Puritan Bennett 980
Puritan Bennett 980
Puritan Bennett 980
Puritan Bennett
980 Series Ventilator
TM
Copyright Information
COVIDIEN, COVIDIEN with logo, and positive results for life are U.S and internationally registered trademarks of COVIDIEN AG. All other brands are trademarks of a Covidien company or
of their respective owners.
2014 COVIDIEN.
The information contained in this manual is the sole property of Covidien and may not be
duplicated without permission. This manual may be revised or replaced by Covidien at any time
and without notice. Ensure this manual is the most current applicable version. If in doubt,
contact Covidiens technical support department or visit the Puritan Bennett product manual
web page at:
http://www.covidien.com
Click: Our Products > Respiratory & Monitoring Products > Brands > Puritan Bennett. Click
Sales and Support Center > Product Manuals and Directions for Use, then follow the prompts
to select the desired manual.
While the information set forth herein is believed to be accurate, it is not a substitute for the
exercise of professional judgement.
The ventilator should be operated and serviced only by trained professionals.
Covidiens sole responsibility with respect to the ventilator and software, and its use, is as
stated in the limited warranty provided.
Nothing in this document shall limit or restrict in any way Covidiens right to revise or otherwise
change or modify the equipment (including its software) described herein, without notice. In
the absence of an express, written agreement to the contrary, Covidien has no obligation to
furnish any such revisions, changes, or modifications to the owner or user of the equipment
(including its software) described herein.
Table of Contents
1
Introduction
1.1
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1
1.1.1 Related Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1
1.2
Global Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . .1-2
1.3
Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
1.3.1 Safety Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
1.3.2 Warnings Regarding Fire Hazards
. . . . . . . . . . . . . . . . . . . . .1-3
1.3.3 General Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4
1.3.4 Warnings Regarding Environment of Use . . . . . . . . . . . . . . . .1-7
1.3.5 Warnings Before Using Equipment
. . . . . . . . . . . . . . . . . . . .1-8
1.3.6 Warnings Regarding Electrical Power . . . . . . . . . . . . . . . . . . .1-8
1.3.7 Warnings Regarding Ventilator Settings . . . . . . . . . . . . . . . . .1-9
1.3.8 Warnings Regarding Hoses, Tubing, and Accessories . . . . . . .1-9
1.3.9 Warnings Regarding Gas Sources
. . . . . . . . . . . . . . . . . . . .1-11
1.3.10 Warnings Regarding Infection Control . . . . . . . . . . . . . . . . .1-12
1.3.11 Warnings Regarding Ventilator Maintenance . . . . . . . . . . . .1-13
1.3.12 Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-13
1.3.13 Notes
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-14
1.4
Obtaining Technical Assistance . . . . . . . . . . . . . . . . . . . .1-15
1.4.1 Technical Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-15
1.4.2 On-Screen Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-18
1.5
Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . .1-19
1.6
Manufacture Date
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-19
1.7
Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-20
1.8
Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . .1-20
2
Product Overview
2.1
2.2
2.3
2.4
2.5
2.6
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1
Ventilator Description . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2
Indications For Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4
Components List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-5
Product Views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-6
GUI Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-6
GUI Rear View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7
BDU Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8
BDU Rear View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-10
2.6.1
2.6.2
2.6.3
2.6.4
Installation
3.1
3.2
3.3
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-1
Safety Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-1
Product Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2
How to Assemble Ventilator Components . . . . . . . . . . . . . . .3-2
Product Power Sources . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2
Product Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4
Product Connectivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5
Connecting the Ventilator to AC Power . . . . . . . . . . . . . . . .3-5
Connecting the Gas Supplies . . . . . . . . . . . . . . . . . . . . . . . . .3-7
Filter Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10
Connecting the Patient Circuit . . . . . . . . . . . . . . . . . . . . . . .3-14
How to Install Accessories . . . . . . . . . . . . . . . . . . . . . . . .3-18
Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-18
Battery Testing
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-23
Battery Performance Test Results . . . . . . . . . . . . . . . . . . . . .3-23
Battery Life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-25
Battery Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-25
Flex Arm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-25
Humidifier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-27
Ventilator Operating Modes . . . . . . . . . . . . . . . . . . . . . .3-30
Normal Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-30
Quick Start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-30
3.3.1
3.3.2
3.4
3.5
3.5.1
3.5.2
3.5.3
3.5.4
3.6
3.6.1
3.6.2
3.6.3
3.6.4
3.6.5
3.6.6
3.6.7
3.7
3.7.1
3.7.2
ii
Operation
4.1
4.2
4.3
4.4
4.5
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-1
Ventilator Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-1
Ventilator Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2
User Interface Management . . . . . . . . . . . . . . . . . . . . . . .4-2
Ventilator Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7
Ventilator Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-10
Apnea Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-15
Alarm Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-16
Alarm Screen During Operation . . . . . . . . . . . . . . . . . . . . . .4-18
Making Ventilator Settings Changes . . . . . . . . . . . . . . . . . .4-19
Constant Timing Variable During Respiratory Rate Changes .4-20
Predicted Body Weight (PBW) Calculation . . . . . . . . . . .4-21
Non-invasive Ventilation (NIV) . . . . . . . . . . . . . . . . . . . .4-22
NIV Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-22
NIV Breathing Interfaces . . . . . . . . . . . . . . . . . . . . . . . . . . .4-22
NIV Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-23
Conversion from INVASIVE to NIV Vent Type . . . . . . . . . . . .4-24
Conversion from NIV to INVASIVE Vent Type . . . . . . . . . . . .4-25
High Spontaneous Inspiratory Time Limit Setting . . . . . . . . .4-26
NIV Apnea Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-27
NIV Alarm Settings
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-27
Manual Inspiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-28
Respiratory Mechanics Maneuvers . . . . . . . . . . . . . . . . .4-28
Inspiratory Pause Maneuver . . . . . . . . . . . . . . . . . . . . . . . . .4-30
Expiratory Pause Maneuver . . . . . . . . . . . . . . . . . . . . . . . . .4-31
Other Respiratory Maneuvers . . . . . . . . . . . . . . . . . . . . . . . .4-32
Oxygen Sensor Function . . . . . . . . . . . . . . . . . . . . . . . . .4-32
4.5.1
4.5.2
4.5.3
4.5.4
4.5.5
4.5.6
4.6
4.7
4.7.1
4.7.2
4.7.3
4.7.4
4.7.5
4.7.6
4.7.7
4.7.8
4.8
4.9
4.9.1
4.9.2
4.9.3
4.10
iii
5.1
5.2
5.3
5.4
5.6
5.7
5.8
5.9
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-1
Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-1
Data Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-1
Data Transfer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-1
GUI Screen Capture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2
Communication Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-3
Comm Port Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . .5-4
Serial Commands
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-5
RSET Command . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-5
SNDA Command . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-6
SNDF Command . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-10
Communication Ports . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-17
Port Use
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-19
Retrieving Stored Data . . . . . . . . . . . . . . . . . . . . . . . . . . .5-20
Display Configurability
. . . . . . . . . . . . . . . . . . . . . . . . . .5-20
Printing Data or Screen Captures . . . . . . . . . . . . . . . . . .5-21
Connectivity to External Systems . . . . . . . . . . . . . . . . . .5-21
Performance
5.4.1
5.4.2
5.4.3
5.4.4
5.4.5
5.4.6
5.4.7
5.5
5.5.1
6.1
6.2
6.3
6.4
iv
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-1
System Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-1
Environmental Considerations . . . . . . . . . . . . . . . . . . . . .6-1
Ventilator Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-1
6.4.1 Ventilation Type
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-2
6.4.2 Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-2
Preventive Maintenance
7.1
7.2
7.3
7.4
7.5
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-1
Ventilator Operational Time . . . . . . . . . . . . . . . . . . . . . . .7-1
Preventive Maintenance Intervals . . . . . . . . . . . . . . . . . . .7-1
Surface Cleaning of Exterior Surfaces . . . . . . . . . . . . . . . .7-4
Component Cleaning and Disinfection . . . . . . . . . . . . . . .7-6
Condensate Vial Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . .7-8
Expiratory Filter Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-9
Exhalation Valve Flow Sensor Assembly Disinfection
. . . . . .7-12
Exhalation Valve Flow Sensor Assembly Reassembly . . . . . . .7-20
Exhalation Valve Flow Sensor Assembly Replacement . . . . . .7-22
Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-23
Component Sterilization . . . . . . . . . . . . . . . . . . . . . . . . .7-23
Service Personnel Preventive Maintenance . . . . . . . . . .7-25
Safety Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-25
7.5.1
7.5.2
7.5.3
7.5.4
7.5.5
7.5.6
7.6
7.7
7.8
vi
7.9
7.10
7.11
Troubleshooting
8.1
8.2
8.3
8.4
8.5
8.6
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1
Problem Categories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1
How to Obtain Ventilator Service . . . . . . . . . . . . . . . . . . .8-1
Used Part Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1
Ventilator Logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2
Diagnostic Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-4
Accessories
9.1
9.2
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-1
General Accessory Information . . . . . . . . . . . . . . . . . . . . .9-2
10
Theory of Operations
10.1
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-1
10.2
Theoretical Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-3
10.3
Applicable Technology . . . . . . . . . . . . . . . . . . . . . . . . . . .10-3
10.4
Inspiration Detection and initiation . . . . . . . . . . . . . .10-4
10.4.1 Pressure Triggering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-5
10.4.2 Flow Triggering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-6
10.4.3 Time Triggers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-8
10.4.4 Operator-initiated Triggers . . . . . . . . . . . . . . . . . . . . . . . . . .10-8
10.4.5 IE Sync Trigger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-8
10.5
Exhalation Detection and Initiation . . . . . . . . . . . . . .10-9
10.5.1 Airway Pressure Method . . . . . . . . . . . . . . . . . . . . . . . . . . .10-9
10.5.2 Percent Peak Flow Method . . . . . . . . . . . . . . . . . . . . . . . .10-10
10.5.3 Time-cycling Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-11
10.5.4 IE Sync Cycling
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-11
10.5.5 Backup Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-12
10.5.6 Time Limit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-12
10.5.7 High Circuit Pressure Limit . . . . . . . . . . . . . . . . . . . . . . . . .10-12
10.5.8 High Ventilator Pressure Limit . . . . . . . . . . . . . . . . . . . . . .10-12
10.5.9 High Inspired Tidal Volume Limit . . . . . . . . . . . . . . . . . . . .10-12
10.6
Compliance and BTPS Compensation . . . . . . . . . . . . . .10-13
10.6.1 Compliance Compensation in Volume-based Breaths
. . . .10-13
vii
viii
Specifications
11.1
11.2
11.3
11.4
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-1
Measurement Uncertainty . . . . . . . . . . . . . . . . . . . . . . . .11-1
Physical Characteristics
. . . . . . . . . . . . . . . . . . . . . . . . . .11-2
Electrical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . .11-6
ix
11.5
Interface Requirements . . . . . . . . . . . . . . . . . . . . . . . . . .11-6
11.6
Environmental Specifications . . . . . . . . . . . . . . . . . . . . .11-7
11.7
Performance Specifications . . . . . . . . . . . . . . . . . . . . . . .11-8
11.7.1 Ranges and Resolutions . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-8
11.8
Regulatory Compliance . . . . . . . . . . . . . . . . . . . . . . . . .11-28
11.9
Manufacturers Declaration . . . . . . . . . . . . . . . . . . . . . .11-30
11.10
Safety Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-35
11.11
Essential Performance Requirements . . . . . . . . . . . . . .11-35
A
A.1
A.2
A.3
A.4
A.5
A.6
A.7
A.8
A.9
A.9.1
A.9.2
A.9.3
A.9.4
A.10
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
Safety Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . A-2
Setting Up BiLevel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
Using Pressure Support with BiLevel . . . . . . . . . . . . . . . A-4
Manual Inspirations in BiLevel Mode . . . . . . . . . . . . . . . A-5
Respiratory Mechanics Maneuvers in BiLevel . . . . . . . . A-6
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-6
Technical Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-6
Synchrony in BiLevel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7
Patient Monitoring in BiLevel . . . . . . . . . . . . . . . . . . . . . . . . A-8
APRV Strategy in BiLevel . . . . . . . . . . . . . . . . . . . . . . . . . . . A-9
Technical Structure of BiLevel
. . . . . . . . . . . . . . . . . . . . . . A-10
Mode Changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-10
B.1
B.2
B.3
B.4
B.5
B.6
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
Safety Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . B-2
Leak Sync . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-2
Setting Up Leak Sync . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3
When Leak Sync is Enabled . . . . . . . . . . . . . . . . . . . . . . . B-4
Adjusting Disconnect Sensitivity (DSENS) . . . . . . . . . . . . . . . . .B-5
Monitored Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-6
Technical Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-8
Inspired Tidal Volume (VTL) Accuracy During Leak Sync . . . . .B-8
Exhaled Tidal Volume (VTE) Accuracy During Leak Sync . . . . .B-8
%LEAK Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-9
Circuit Disconnect Alarm During Leak Sync . . . . . . . . . . . . . .B-9
B.6.1
B.6.2
B.7
B.7.1
B.7.2
B.7.3
B.7.4
IE Sync Appendix
C.1
C.2
C.3
C.4
C.5
C.6
C.7
C.8
C.9
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Safety Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . .
IE Sync Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Setting Up IE Sync
..............................
Setting Up IE Sync for Monitoring Only . . . . . . . . . . . . .
IE Sync Monitoring Display . . . . . . . . . . . . . . . . . . . . . . .
Technical Description . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Alarms during IE Sync
...........................
PAV+ Appendix
D.1
D.2
D.3
D.4
D.4.1
D.4.2
D.4.3
D.4.4
D.4.5
D.4.6
D.4.7
D.4.8
D.5
D.5.1
D.5.2
D.5.3
D.5.4
D.5.5
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-1
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-1
Safety Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . D-2
PAV+ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-3
Setting Up PAV+ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-5
PBW and Tube ID
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-6
Apnea Parameters Adjustment
. . . . . . . . . . . . . . . . . . . . . . D-7
Alarm Settings Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . D-8
PAV+ Ventilator Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . D-8
PAV+ Alarm Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-8
Monitored Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-9
PAV+ Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-10
Ventilator Settings/Guidance . . . . . . . . . . . . . . . . . . . . D-10
Specified performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-11
Graphics Displays in PAV+ . . . . . . . . . . . . . . . . . . . . . . . . . D-11
WOB Terms and Definitions . . . . . . . . . . . . . . . . . . . . . . . . D-12
Technical Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-14
Protection Against Hazard . . . . . . . . . . . . . . . . . . . . . . . . . D-19
E.1
E.2
E.3
E.4
E.5
E.6
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-1
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-1
Safety Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . .E-1
Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-2
Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-3
Neonatal Door and Filter Installation . . . . . . . . . . . . . . . .E-3
C-1
C-1
C-1
C-2
C-2
C-4
C-5
C-7
C-7
xi
E.7
E.8
E.9
E.9.1
E.9.2
E.9.3
E.9.4
E.9.5
E.9.6
E.9.7
F
F.1
F.2
F.3
F.4
F.5
F.6
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .F-1
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .F-1
Safety Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . .F-1
Software/Hardware Requirements . . . . . . . . . . . . . . . . . .F-2
Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .F-2
Proximal Flow Option Description . . . . . . . . . . . . . . . . . .F-5
Proximal Flow Option components
. . . . . . . . . . . . . . . . . . . . F-5
On-screen symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .F-6
Sensor Calibration and Sensor Line Purging . . . . . . . . . .F-8
SST Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .F-9
Attaching the Proximal Flow Sensor for SST . . . . . . . . . . . . . F-11
Disabling/Enabling the Proximal Flow Option . . . . . . . .F-12
Using the Proximal Flow Sensor . . . . . . . . . . . . . . . . . . .F-13
How to Perform a Manual Purge . . . . . . . . . . . . . . . . . . . . . F-15
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .F-16
Ranges, Resolutions, and Accuracies
. . . . . . . . . . . . . . .F-17
Proximal Flow Sensor Specifications . . . . . . . . . . . . . . . . . . . F-17
Part Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .F-18
F.6.1
F.7
F.8
F.9
F.9.1
F.10
F.11
F.11.1
F.12
F.13
F.13.1
F.14
Glossary
xii
List of Tables
Table1-1.
Table1-2.
Table2-1.
Table2-2.
Table2-3.
Table2-4.
Table2-5.
Table2-6.
Table2-7.
Table2-8.
Table2-9.
Table2-10.
Table2-11.
Table3-1.
Table3-2.
Table3-3.
Table3-4.
Table3-5.
Table3-6.
Table3-7.
Table3-8.
Table3-9.
Table4-1.
Table4-2.
Table4-3.
Table4-4.
Table5-1.
Table5-2.
Table6-1.
Table6-2.
Table6-3.
Table6-4.
Table6-5.
Table6-6.
Table7-1.
Table7-2.
Table7-3.
Table7-4.
Table7-5.
xiii
Table9-1.
Table10-1.
Table10-2.
Table10-3.
Table10-4.
Table10-5.
Table10-6.
Table10-7.
Table10-8.
Table10-9.
Table10-10.
Table11-1.
Table11-2.
Table11-3.
Table11-4.
Table11-5.
Table11-6.
Table11-7.
Table11-8.
Table11-9.
Table11-10.
Table11-11.
Table11-12.
Table11-13.
Table11-14.
Table11-15.
Table11-16.
Table11-17.
Table11-18.
TableA-1.
TableB-1.
TableB-2.
TableB-3.
TableC-1.
TableD-1.
TableD-2.
TableD-3.
TableD-4.
TableE-1.
TableE-2.
TableE-3.
xiv
TableE-4.
Monitored Inspired Volume (VTI) Accuracy . . . . . . . . . . . . . . . . . . E-12
Monitored Exhaled Tidal Volume (VTE) Accuracy . . . . . . . . . . . . E-13
TableE-5.
TableF-1.
Safety Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-2
TableF-2.
Proximal Flow Option Patient Data Symbols . . . . . . . . . . . . . . . . . F-8
TableF-3.
Proximal Flow Option SST test Sequence. . . . . . . . . . . . . . . . . . . . F-10
TableF-4.
Proximal Flow Sensor Volume Accuracy. . . . . . . . . . . . . . . . . . . . . F-17
TableF-5.
Proximal Flow Sensor Specifications . . . . . . . . . . . . . . . . . . . . . . . . F-18
TableF-6.
Proximal Flow Option Component Part Numbers. . . . . . . . . . . . F-18
TableGlossary-1.Glossary of Ventilation Terms . . . . . . . . . . . . . . . . . . . . . Glossary-1
TableGlossary-2.Units of Measure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Glossary-9
TableGlossary-3.Technical Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . .Glossary-10
xv
xvi
List of Figures
Figure2-1.
Figure2-2.
Figure2-3.
Figure2-4.
Figure2-5.
Figure2-6.
Figure2-7.
Figure2-8.
Figure2-9.
Figure2-10.
Figure2-11.
Figure2-12.
Figure3-1.
Figure3-2.
Figure3-3.
Figure3-4.
Figure3-5.
Figure3-6.
Figure3-7.
Figure3-8.
Figure3-9.
Figure3-10.
Figure3-11.
Figure3-12.
Figure3-13.
Figure3-14.
Figure3-15.
Figure4-1.
Figure4-2.
Figure4-3.
Figure4-4.
Figure4-5.
Figure4-6.
Figure4-7.
Figure4-8.
Figure4-9.
Figure4-10.
Figure4-11.
Figure4-12.
xvii
xviii
xix
xx
1 Introduction
1.1
Overview
This manual contains information for operating the Puritan Bennett 980
Series Ventilators. Before operating the ventilator system, thoroughly read this
manual. The latest version of this manual is available on the Internet at:
http://www.covidien.com
Related Documents
Documentation is available online at the URL above. Covidien makes available
all appropriate information relevant to use and service of the ventilator. For
further assistance, contact your local Covidien representative.
The Puritan Bennett 980 Series Ventilator Service Manual Provides information to Covidien-trained service technicians for use when testing, troubleshooting, repairing, and upgrading the ventilator.
Symbol definitions
1-1
Introduction
1.2
Description
Serial number
Part number
Manufacturer
This side up
Fragile
Humidity limitations: 10% to 95% relative humidity, non-condensing (operation and storage)
Keep dry
CSA certification mark that signifies the product has been evaluated
to the applicable ANSI/Underwriters Laboratories Inc. (UL) and CSA
standards for use in the US and Canada.
1-2
Operators Manual
Safety Information
Description
US federal law restricts this device to sale by or on the order of a
physician.
1.3
1.3.1
Safety Information
Safety Symbol Definitions
This section contains safety information for users, who should always exercise
appropriate caution while using the ventilator.
Table1-2.Safety Symbol Definitions
Symbol
Definition
WARNING
Warnings alert users to potential serious outcomes (death, injury, or adverse
events) to the patient, user, or environment.
Caution
Cautions alert users to exercise appropriate care for safe and effective use of the
product.
Note
Notes provide additional guidelines or information.
1.3.2
Operators Manual
1-3
Introduction
1.3.3
1-4
WARNING:
To avoid a fire hazard, keep all components of the system away from all
sources of ignition (such as matches, lighted cigarettes, flammable medical
gases, and/or heaters). Oxygen-rich environments accelerate combustibility.
WARNING:
In case of fire or a burning smell, immediately take the following actions if it
is safe to do so: disconnect the patient from the ventilator and disconnect the
ventilator from the oxygen supply, facility power, and all batteries. Provide
alternate method of ventilatory support to the patient, if required.
WARNING:
Replacement of batteries by inadequately trained personnel could result in an
unacceptable risk, such as excessive temperatures, fire, or explosion.
WARNING:
To minimize fire hazard, inspect and clean or replace, as necessary, any
damaged ventilator parts that come into contact with oxygen.
WARNING:
To prevent electrostatic discharge (ESD) and potential fire hazard, do not use
antistatic or electrically conductive hoses or tubing in or near the ventilator
breathing system.
General Warnings
WARNING:
To ensure proper operation and avoid the possibility of physical injury, only
qualified medical personnel should attempt to set up the ventilator and
administer treatment with the ventilator.
WARNING:
In case of ventilator failure, the lack of immediate access to appropriate
alternative means of ventilation can result in patient death. An alternative
source of ventilation, such as a self-inflating, manually-powered resuscitator
(as specified in ISO 10651-4 with mask) should always be available when
using the ventilator.
Operators Manual
Safety Information
WARNING:
Patients on mechanical ventilation should be monitored by clinicians for
proper patient ventilation.
WARNING:
The ventilator system is not intended to be a comprehensive monitoring
device and does not activate alarms for all types of conditions. For a detailed
understanding of ventilator operations, be sure to thoroughly read this
manual before attempting to use the ventilator system.
WARNING:
To prevent patient injury, do not use the ventilator if it has a known
malfunction. Never attempt to override serious malfunctions. Replace the
ventilator and have the faulty unit repaired by trained service personnel.
WARNING:
To prevent patient injury, do not make unauthorized modifications to the
ventilator.
WARNING:
To prevent injury and avoid interfering with ventilator operation, do not
insert tools or any other objects into any of the ventilators openings or ports.
WARNING:
The audio alarm volume level is adjustable. The operator should set the
volume at a level that allows the operator to distinguish the audio alarm
above background noise levels. Reference To adjust alarm volume, p. 3-41 for
instructions on alarm volume adjustment.
WARNING:
Do not silence, disable, or decrease the volume of the ventilators audible
alarm if patient safety could be compromised.
WARNING:
If increased pressures are observed during ventilation, it may indicate a
problem with the ventilator. Check for blocked airway, circuit occlusion,
and/or run SST.
Operators Manual
1-5
Introduction
1-6
WARNING:
The LCD panel contains toxic chemicals. Do not touch broken LCD panels.
Physical contact with a broken LCD panel can result in transmission or
ingestion of toxic substances.
WARNING:
If the Graphical User Interface (GUI) display/LCD panel is blank or experiences
interference and cannot be read, check the patient, then verify via the status
display that ventilation is continuing as set. Because breath delivery is
controlled independently from the GUI, problems with the display will not, by
themselves, affect ventilation. The ventilator, however, should be replaced as
soon as possible and repaired by qualified service personnel.
WARNING:
The Puritan Bennett 980 Series Ventilator contains phthalates. When used
as indicated, very limited exposure to trace amounts of phthalates may occur.
There is no clear clinical evidence that this degree of exposure increases
clinical risk. However, in order to minimize risk of phthalate exposure in
children and nursing or pregnant women, this product should only be used as
directed.
WARNING:
Even though the 980 Series Ventilator meets the standards listed in
Chapter 11, the internal Lithium-ion battery of the device is considered to
be Dangerous Goods (DG) Class 9 - Miscellaneous, when transported in
commerce. The 980 Series Ventilator and/or the associated Lithium-ion
battery are subject to strict transport conditions under the Dangerous
Goods Regulation for air transport (IATA: International Air Transport
Association), International Maritime Dangerous Goods code for sea and
the European Agreement concerning the International Carriage of
Dangerous Goods by Road (ADR) for Europe. Private individuals who
transport the device are excluded from these regulations although for air
transport some requirements may apply.
Operators Manual
Safety Information
1.3.4
limit the air circulation around the ventilator, potentially causing overheating;
WARNING:
To avoid injury, do not position the ventilator in a way that makes it difficult
to disconnect the patient.
WARNING:
To ensure proper operation, do not position the ventilator in a way that
makes it difficult to access the AC power cord.
WARNING:
Do not use the ventilator in a hyperbaric chamber. It has not been validated
for use in this environment.
WARNING:
Do not use the ventilator in the presence of strong magnetic fields. Doing so
could cause a ventilator malfunction.
WARNING:
Do not use the ventilator during radiotherapy (i.e. cancer treatment using
ionizing radiation), as doing so could cause a ventilator malfunction.
WARNING:
To avoid the risk of ventilator malfunction, operate the ventilator in an
environment that meets specifications. Reference Environmental
Specifications, p. 11-7.
Operators Manual
1-7
Introduction
1.3.5
1.3.6
1-8
WARNING:
Do not use the ventilator as an EMS transport ventilator. It has not been
approved or validated for this use.
Operators Manual
Safety Information
1.3.7
1.3.8
Operators Manual
1-9
Introduction
1-10
WARNING:
Adding accessories to the ventilator can change the pressure gradient across
the ventilator breathing system (VBS) and affect ventilator performance.
Ensure that any changes to the ventilator circuit configurations do not exceed
the specified values for circuit compliance and for inspiratory or expiratory
limb total resistance. Reference Technical Specifications, p. 11-3. If adding
accessories to the patient circuit, always run SST to establish circuit
compliance and resistance prior to ventilating the patient.
WARNING:
Use of a nebulizer or humidifier can lead to an increase in the resistance of
inspiratory and expiratory filters. Monitor the filters frequently for increased
resistance or blockage.
WARNING:
During transport, the use of breathing tubing without the appropriate cuffed
connectors may result in the circuit becoming detached from the ventilator.
WARNING:
The added gas from an external pneumatic nebulizer can adversely affect
spirometry, delivered O2%, delivered tidal volumes, and breath triggering.
Additionally, aerosolized particulates in the ventilator circuit can lead to an
increase in expiratory filter resistance.
WARNING:
Carefully route patient tubing and cabling to reduce the possibility of patient
entanglement or strangulation.
WARNING:
Always use filters designed for use with the Puritan Bennett 980 Series
Ventilator. Do not use filters designed for use with other ventilators.
Reference Covidien Accessories and Options, p. 9-4 for relevant filter part
numbers.
WARNING:
To avoid liquid entering the ventilator, empty the expiratory condensate vial
before fluid reaches the maximum fill line.
Operators Manual
Safety Information
1.3.9
WARNING:
Accessory equipment connected to the analog and digital interfaces must be
certified according to IEC 60601-1. Furthermore, all configurations shall
comply with the system standard IEC 60601-1-1. Any person who connects
additional equipment to the signal input part or signal output part of the
ventilator system configures a medical system, and is therefore responsible
for ensuring the system complies with the requirements of the system
standard IEC 60601-1-1. If in doubt, consult Covidien Technical Services at
1.800.255.6774 or your local representative.
Operators Manual
1-11
Introduction
WARNING:
The ventilator should be connected to a gas pipeline system compliant to ISO
7396-1:2007 because:
Installation of the ventilator on a non-ISO 7396-1:2007 compliant gas pipeline system may exceed the pipeline design flow capacity.
1.3.10
1-12
The ventilator is a high-flow device and can interfere with the operation
of other equipment using the same gas source if the gas pipeline system
is not compliant to ISO 7396-1:2007.
Operators Manual
Safety Information
1.3.11
1.3.12
Cautions
Caution:
To prevent possible equipment damage, ensure the casters are locked to
prevent inadvertent movement of the ventilator during routine maintenance,
or when the ventilator is on an incline.
Caution:
Do not use sharp objects to make selections on the display or keyboard.
Caution:
To ensure optimal performance, keep the GUI touch screen and keyboard
clean and free from foreign substances. Reference Surface Cleaning Agents,
p. 7-5.
Caution:
To avoid moisture entering the ventilator and possibly causing a malfunction,
Covidien recommends using a wall air water trap when using piped medical
air from a facility-based air compressor.
Caution:
Use only the cleaning agents specified. Reference Surface Cleaning Agents, p.
7-5. for approved cleaning agents.
Operators Manual
1-13
Introduction
1.3.13
1-14
Caution:
Do not block cooling vents.
Caution:
Ensure proper connection and engagement of expiratory and inspiratory
filters.
Caution:
Follow instructions for proper GUI and BDU (breath delivery unit) mounting
as described in the Puritan Bennett 980 Series Ventilator Installation
Instructions.
Caution:
Follow proper battery installation instructions as described in this manual.
Caution:
When transferring the ventilator from storage conditions, allow its
temperature to stabilize at ambient conditions prior to use.
Caution:
Remove extended and primary batteries from ventilator prior to transporting
in a vehicle. Failure to do so could result in damage to the ventilator.
Notes
Note:
Federal law (USA) restricts the sale of this device except by or on the order of a
physician.
Note:
When using non-invasive ventilation (NIV), the patients actual exhaled volume may
differ from the exhaled volume reported by the ventilator due to leaks around the
mask.
Operators Manual
Safety Information
1.4
1.4.1
Note:
When utilizing a closed-suction catheter system, the suctioning procedure can be
executed using existing mode, breath type, and settings. To reduce potential for
hypoxemia during the procedure, elevated delivered oxygen can be enabled using the
Elevate O2 control. Reference To adjust the amount of elevated O2 delivered for two
minutes, p. 3-40.
The following table lists Covidien Service Centers, addresses, telephone, and
Fax numbers:
Operators Manual
1-15
Introduction
1-16
Covidien Argentina
Aguero 351
Capital Federal - 1171
ABC, Argentina
Tel: (5411) 48635300
Fax: (5411) 48634142
Covidien Asia
Singapore Regional
Service Centre
15 Pioneer Hub, #06-04
Singapore 627753
Tel (65) 6578 5288
Fax (65) 6515 5260
Covidien Australia
52A Huntingwood Drive
Huntingwood, NSW
2148
Australia
Tel: (+61) 1800 - 350702
Fax: (+61) 2967 - 18118
Covidien Belgium
BVBA/SPRL.
Generaal De Wittelaan 9/5
2800 Mechelen
Belgium
Tel +32 15 29 44 50
Fax +32 15 29 44 55
Covidien Brazil
Av. Das Naes Undias
12995 Andar 23 - Brooklin
So Paulo, SP
Brasil 04578-000
Tel: (5511) 2187-6200
Fax: (5511) 2187-6380
Covidien Canada
19600 Clark Graham
Baie d'Urfe, QC, H9X
3R8
Canada
Tel:1-514-332-1220,
Select Option 2
Fax: 1-514-695-4965
Covidien Chile
Camino lo Boza (Ex 8395)
Pudehuel
Santiago
Chile
Tel: (562) 739 - 3000
Fax: (562) 783 - 3149
Covidien China
2F, Tyco Plaza
99 Tian Zhou Rd
Shang Hai 200233
P.R. China
Tel: (+86) 4008 1886
86
Fax: (+86) 2154 4511
18
Covidien Colombia
Edificio Prados de la
Morea
Carretera Central Del
Norte
(Cra 7a)Kilometro 18,
Chia-Cundinamarca
Bogota, Colombia
Tel: (571) 619-5469
Fax: (571) 619-5425
Covidien ECE
Proseck 851/ 64
190 00 Prague
Czech Republc
Tel +42 024 109 57 35
Fax + 42 02 3900 0437
Covidien Danmark
A/S
Langebrogade 6E, 4.
th
DK-1411 Kbenhavn
K
Danmark
Tel +45 4368 2171
Fax:+45 4368 2172
Covidien Deutschland
GmbH
Gewerbepark 1r
D-93333 Neustadt/
Donau
Germany
Tel + 49 (0) 9445 95 9 0
Fax + 49 (0) 9445 95 9
155
Covidien ECE
Galvahiho 7 / A
82104 Bratislava Slovakia
Tel +420 2 41 095 735
Fax +420 2 39 000 437
Covidien Finland Oy
Pursimiehenkatu
26-39C,
PL407
FIN-00151 Helsinki
Finland
Te. +358 9725 192 88
Fax +358 9725 192 89
Covidien France
SAS
2 Rue Denis Diderot
78990 Elancourt
France
Tel +33 (0) 13079 80
00
Fax +33 (0) 130 79 80
30
Covidien India
10th Floor Building No
9B
DLF Cyber City Phase III
Gurgaon
Haryana - 122002
India
Tel + 91 1244 709800
Fax + 91 1244 206850
Covidien ECE
Marissy u.7.
1095 Budapest
Hungary
Tel + 36 1880 7975
Fax + 36 1777 4932
Operators Manual
Safety Information
Covidien Ireland
Block G, Ground
Floor,
Cherrywood Business
Park,
Loughlinstown
County Dublin,
Ireland
Tel +353 (0)
1.4073173
Fax +353(0)
1.4073174
Covidien Israel
5, Shasham St.
North Industrial Park
POB3069
Caesarea, 38900
Tel +972 4.627 73 88
Fax+972 4.627 76 88
Covidien Korea
5F, Hibrand Living
Gwan, #215,
Yangjae-Dong,
Seocho-Gu
Seoul, Korea
Tel: +822 570 5459
Fax: +822 570 5499
Covidien Mexico
Insurgentes Sur # 863,
Piso 16
Col. Npoles
Del. Benito Juarez
Mexico, D.F. 03810
Mexico
Tel: (5255) 5804-1524
Fax: (5255) 5536-1326
Covidien Nederland
BV
Hogeweg 105
NL5301 LL
ZaltbommelNederland
Tel0418 57 66 00
Fax 0418 57 67 91
Covidien Norge AS
Bankveinen 1,
Postboks 343
N-1372 Askerr
Norway
Tel +47 2415 98 87
Fax +47 2415 15 98
88
Covidien Panama
Parque Industrial Costa
del Esta
Calle Primera, Edifio #
109
Panama City, Panama
Tel: (507) 264-7337
Fax: (507) 236-7408
Covidien Polska
Al. Jerozolimskie 162
02-342 Warszawa.
Polska
Tel +48 22 312 20 00
Fax +48 22 312 20 20
Covidien Puerto
Rico
Palmas Industrial Park
Road 869 Km 2.0
Bdlg. #1
Catao, PR 00962
Tel. 787-993-7250
Ext. 7222 & 7221
Fax 787-993-7234
Covidien Russia
53 bld. 5 Dubininskaya
StreetMoscow
RUSSIA. 119054
Tel +70 495 933 64 69
Fax +70 495 933 64 68
Operators Manual
1-17
Introduction
Covidien Sverige AB
Hemvrnsgatan 9, Box
54
SE-171 74 Solna
Sweden
Tel +46(0)8517 615 73
Fax + 46 (0)8 517 615 79
Covidien UK
4500 Parkway
Whiteley, Fareham
Hampshire
PO157NY, United
Kingdom
Tel +44 (0) 1329
2240002
Fax +44 (0) 1329
220213
Covidien USA
2101 Faraday Ave
Carlsbad, CA 92008
Phone: 1-800-255-6774
(option 4
Email: VentTechSupport@covidien.com
Covidien Switzerland
Roosstrasse 53
Ch-8832 Wollerau
Switzerland
Tel +41(0)44 786 50 50
Fax +41 (0) 44 78650 10
Covidien Thailand
319 Chamchuri Square 17th
Floor, Unit 1-8,
Phayathai Road
Pathumwan, Bangkok
10330, Thailand
Tel +66-2 207-3 100
Fax +66-2 207 - 3101
For online Technical support, visit the SolvITSM Center Knowledge Base at
www.covidien.com. The SolvIT Center provides answers to frequently asked
questions about the ventilator system and other Puritan Bennett products 24
hours a day, seven days a week.
1.4.2
On-Screen Help
The ventilator is equipped with an on-screen help system that enables users to
select an item on the screen and display a description of that item. Follow the
procedure below to access and use on-screen help.
Accessing On-screen Help Topics
Help topics on the ventilator are called tooltips. If a tooltip is available, a glowing
blue outline appears around the item in question.
To access tooltips
1.
Touch the item in question for a period of at least 0.5 s, or drag the help icon (the
question mark icon appearing at the lower right of the GUI screen) to the item in question. A tooltip appears with a short description of the item. Most screen items have
tooltips associated with them, providing the operator with access to a multitude of
help topics.
2.
1-18
Operators Manual
Safety Information
3.
Touch close to close the dialog, or let it fade away after five (5) seconds.
Note:
Dragging the help icon causes the tooltip to display in its unexpanded state.
Dragging the help icon and pausing causes a tooltip to display. Continue dragging
to another item to dismiss the last tooltip and display another tooltip.
Other Resources
Additional resources for information about the ventilator can be found in the
Puritan Bennett 980 Series Ventilator Service Manual and appendices in this
manual for BiLevel 2.0, IE Sync, Leak Sync, PAV+, NeoMode 2.0, and Proximal
Flow Sensor options.
1.5
Warranty Information
To obtain warranty information for a covered product, contact Covidien Technical Services at 1.800.255.6774 or call a local Covidien representative.
1.6
Manufacture Date
The graphical User Interface (GUI) and Breath Delivery Unit (BDU) each possess
a specific year of manufacture applicable only for that assembly. These dates
are contained in the serial numbers for each assembly or option. Serial
numbers for the 980 Ventilator final units consist of ten digits, in the following
format:
35ZYYXXXXX
where
Z represents the product code (B= breath delivery unit, G= GUI, P = Proximal Flow
Monitoring option). The product codes shown here are typically the most
common. There may be other product codes shown in the serial number depending upon the particular option(s) purchased.
XXXXX is a sequential number that resets at the beginning of each new year
Operators Manual
1-19
Introduction
Serial numbers are located on labels on the back panels of the GUI and BDU,
and in various locations on product options.
1.7
Manufacturer
Covidien llc, 15 Hampshire Street, Mansfield, MA 02048 USA.
1.8
Electromagnetic Compatibility
The ventilator system complies with the requirements of IEC 60601-1-2:2007
(EMC Collateral Standard) including the E-field susceptibility requirements at a
level of 10 volts per meter, at frequencies from 80 MHz to 2.5 GHz. However,
even at this level of device immunity, certain transmitting devices (cellular
phones, walkie-talkies, cordless phones, paging transmitters, RFID devices,
etc.) emit radio frequencies that could interrupt ventilator operation if operated in a range too close to the ventilator. Practitioners should be aware of possible radio frequency interference if portable devices are operated in close
proximity to the ventilator.
The Puritan Bennett 980 ventilator requires special precautions to be taken
regarding electromagnetic compatibility (EMC) and must be installed and put
into service according to the EMC information provided in Chapter 11 in this
manual.
1-20
Operators Manual
2 Product Overview
2.1
Overview
This chapter contains introductory information for the Puritan Bennett 980
Series Ventilator.
Note:
Items shown in bold-italic font are contained as entries in the glossary.
2-1
Product Overview
The ventilator recognizes the patients breathing effort using pressure triggering (P-TRIG), flow triggering (V-TRIG) or IE Sync triggering (if the IE Sync Option
is installed).Reference Appendix C for more information on the IE Sync Option.
During pressure triggering, as the patient inhales, the airway pressure decreases and the inspiratory pressure transducer (PI) monitors this pressure
decrease.When the pressure drops to at least the value of the pressure sensitivity (PSENS) setting, the ventilator delivers a breath. During flow triggering,
the difference between inspiratory and expiratory flows is monitored. As the
patient inhales, the exhalation valve flow sensor measures less flow, while the
delivery flow sensor measurement remains constant. When the difference
between the two measurements is at least the value of the operator-set flow
sensitivity (VSENS), the ventilator delivers a breath. If the patient is not inhaling,
any difference between delivered flow and expiratory flow is due to flow
sensor inaccuracy or leaks in the ventilator breathing circuit. To compensate for
leaks, which can cause autotriggering, the clinician can increase the VSENS
setting or enable Leak Sync, if available.
Note:
Leak Sync is a software option. Details on its operation are provided in the Leak Sync
appendix in this manual. Reference Appendix B.
A backup pressure triggering threshold of 2 cmH2O is also in effect. This provides enough pressure sensitivity to avoid autotriggering, but will still allow the
ventilator to trigger with acceptable patient effort.
The exhalation valve controls Positive End Expiratory Pressure (PEEP) using
feedback from the expiratory pressure transducer (PE). The valve controller
also cycles the ventilator into the exhalation phase if the PE measurement
equals or exceeds the operator-set high circuit pressure limit. The PE measurement also controls when the safety valve (SV) opens. If PE measures 110
cmH2O or more in the ventilator breathing circuit, the safety valve opens,
allowing the patient to breathe room air (if able to do so) through the valve.
2.2
Ventilator Description
The ventilator system is available in three models. All ventilators provide continuous ventilation to patients requiring respiratory support.
2-2
Operators Manual
Puritan Bennett 980 Neonatal Ventilator The Neonatal model ventilates Neonatal patients with predicted body weights from 0.3 kg to 7.0 kg, and
with tidal volumes for mandatory volume-controlled breaths from 2 mL to 320
mL.
Protection class I
Type BF
Mobile
Internally powered
IP 21 equipment
Continuous operation
Not suitable for use with flammable medical gases (not AP or APG)
Reference BDU Rear Label or Panel Symbols and Descriptions, p. 2-11 for a
description of the meaning of the IP classification.
The ventilator system uses a graphical user interface (GUI) and breath
delivery unit (BDU) for entering patient settings and delivering breaths to the
patient. The GUI contains electronics capable of transferring the clinicians
input (by touching the screen) to the BDU where pneumatic and electronic systems, respectively, generate the breathing parameters.
Operators Manual
2-3
Product Overview
2.3
Note:
Intended typical usage may be defined to include the following for the ventilator
system:
Hospital Use Typically covers areas such as general care floors (GCFs), operating
rooms, special procedure areas, intensive and critical care areas within the hospital
and in hospital-type facilities. Hospital-type facilities include physician office-base
facilities, sleep labs, skilled nursing facilities, surgicenters, and sub-acute centers.
Intra-hospital transport Includes transport of a patient within the hospital or
hospital-type facility. All external hospital transportation (i.e. ambulance or aircraft) is excluded.
2.4
Note:
Federal law (USA) restricts the sale of this device except by or on the order of a
physician.
Contraindications
Do not operate the ventilator in a magnetic resonance imaging (MRI) environment.
2-4
Operators Manual
2.5
Components List
Note:
No parts of the ventilator system contain latex.
Note:
The components in the gas pathway that can become contaminated with bodily fluids
or expired gases during both normal and single fault conditions are:
The typical ventilator system ships with the following packing list. Depending
upon the ventilator system purchased, your list may vary.
Table2-1.Typical Packing List
Quantity
Operators Manual
Item
Inspiratory filter
Expiratory filter
Condensate vial
Power cord
Operators Manual CD
Flex arm
Drain bag
2-5
Product Overview
2.6
2.6.1
Product Views
GUI Front View
Figure2-1.GUI Front View
2-6
Operators Manual
2.6.2
Reference Common Symbols Found on GUI or BDU Labels, p. 2-13 for symbols
found on the GUI or BDU. The Do Not Push symbol found on the GUI, only,
is shown in this table.
Operators Manual
2-7
Product Overview
2.6.3
2-8
Condensate vial
Power switch
Expiratory filter
Status display
AC power indicator
Operators Manual
Description
To Patient port
Operators Manual
2-9
Product Overview
2.6.4
Standard base
Air inlet
Oxygen inlet
Software option labels are applied to the grid located on the back of the ventilator, as shown below and in the previous image (item 4).
2-10
Operators Manual
The following table lists the symbols and descriptions found on BDU or base
labels.
Table2-3.BDU Rear Label or Panel Symbols and Descriptions
Symbol
Description
US federal law restricts this device to sale by or on the order of a physician.
User must consult instructions for use. Symbol is also found on Do not
obstruct labels on both left and right sides of the ventilator, and on
label indication supply gas connections.
Keep away from fire or flame. Oxygen rich environments accelerate
combustibility.
Atmospheric pressure limitations The operational atmospheric pressure range 70 kPa to 106 kPa (10.2 psi to 15.4 psi).
Operators Manual
2-11
Product Overview
Description
Type BF applied part.
CB1
CB2
2-12
Operators Manual
Description
Service mode button (at rear of ventilator).
Description
Do Not Push - Do not push on the GUI
Serial number.
Manufacture date The manufacture date is contained in the serial
number. Reference Manufacture Date, p. 1-19 for details regarding
interpretation of the serial number.
WEEE Proper waste disposal. Follow local governing ordinances
regarding disposing of waste labeled with the WEEE symbol.
Operators Manual
2-13
Product Overview
2.6.5
2-14
Operators Manual
2.7
Mounting Configurations
The ventilator system can be mounted as a free-standing unit standing at the
patients bedside; the BDU with the GUI is mounted on a base with casters and
includes a handle for ease of movement.
2.8
Battery Backup
The ventilator system uses a battery to provide backup power in case AC
power is lost. When operating on battery power, the status display shows the
On Battery Power image, and the GUI displays a representation of battery
charge levels. Reference Typical Status Display Indicators and Messages, p. 230 to for a description of the status display images and messages. An optional,
extended battery is available to lengthen the amount of time the ventilator can
operate on battery power. Reference Using Battery Power, p. 3-3.
Operators Manual
2-15
Product Overview
2.9
2.9.1
Primary Display
The GUI incorporates a 15 display that rotates throughout a 170 angle about
a vertical axis in either direction. The GUI can also be tilted up to 45 from vertical.
The clinician enters ventilation parameters via the GUIs touch screen, also
known as the ventilators primary display. The GUIs keys activate other ventilator functions including screen brightness, display lock, alarm volume, manual
inspiration, inspiratory pause, expiratory pause, alarm reset, and alarm silence.
The GUI displays the following information depending on the state of the ventilator:
2.10
2.10.1
Patient data
Waveforms
Key symbol
Description
Brightness control key Adjusts the GUI screen brightness. Press the key and turn
the knob to adjust the brightness.
2-16
Operators Manual
Description
Display lock key Actuates a lock to prevent inadvertent settings changes to the
ventilator (including the knob function) while the display is locked. The display lock
is useful when cleaning the touch screen. Press the key again to unlock the display.
Alarm volume key Adjusts the alarm volume. The alarm volume cannot be
turned OFF.
Manual inspiration key In A/C, SIMV, and SPONT modes, delivers one manual
breath to the patient in accordance with the current mandatory breath parameters.
In BiLevel mode, transitions from low pressure (PL) to high pressure (PH) (or vice
versa). To avoid breath stacking, a manual inspiration is not delivered during inspiration or during the restricted phase of exhalation. Reference Manual Inspiration,
p. 10-22 for information on the restricted phase of exhalation.
The Manual inspiration key can be used to deliver mandatory breaths to the patient
or to run an inspiratory pause maneuver in SPONT mode. The manual inspiration
key cannot be used to run an expiratory pause maneuver in SPONT mode.
Inspiratory pause key Initiates an inspiratory pause which closes the inspiratory
and exhalation valves and extends the inspiratory phase of a mandatory breath for
the purposes of measuring end inspiratory pressure (PI END) for calculation of
plateau pressure (PPL), static compliance (CSTAT), and static resistance (RSTAT).
Expiratory pause key Initiates an expiratory pause which extends the expiratory
phase of the current breath in order to measure total PEEP (PEEPTOT).
Alarm reset key Clears active alarms or resets high-priority alarms and cancels an
active alarm silence. An alarm reset is recorded in the alarm log if there is an active
alarm. DEVICE ALERT alarms cannot be reset.
Alarm silence key Silences alarms for two minutes. Cancel the alarm silence
function by touching the on-screen Cancel button.
2.10.2
Visual Indicators
The table below shows the GUIs visual indicators. Reference Areas of the GUI,
p. 4-3 for area names.
The alarm silence function has two visual indicators the alarm silence key on
the GUI bezel glows yellow during an alarm silence interval, and a visual count-
Operators Manual
2-17
Product Overview
down timer appears, showing the amount of time the alarm silence interval
has remaining.
Table2-6.GUI Visual Indicators
Symbol
Description
Ventilator Setup (Vent Setup) button. Located at
the lower left corner of the GUI. Touch this
button to open the ventilator setup screen.
Pediatric patient circuit indicator. Indicates pediatric circuit type tested during SST, and in
use.Appears above the Vent Setup button.
Neonatal patient circuit indicator. Indicates neonatal circuit type tested during SST, and in
use.Appears above the Vent Setup button.
2-18
Operators Manual
Description
Elevate O2 control. A constant access icon. Reference Areas of the GUI, p. 4-3. Touch this icon to
increase the set the elevated oxygen concentration to the institutional default O2 configuration
(if institutional default has been configured) for
two minutes, or allows the operator to determine
the additional percentage of oxygen to increase.
The O2 concentration for the two-minute
increase can be set to any value between 1% and
100% O2. If the Elevate O2 function is active,
touching Extend re-starts the two-minute interval. The Elevate O2 function can be terminated
prior to completion of the two-minute interval by
touching Stop. Any time the Elevate O2 control is
activated, an entry is made to the patient data
log.
Screen capture icon. A constant access icon. Reference Areas of the GUI, p. 4-3. Touch this icon
to capture the image displayed on the GUI
screen. Reference To capture GUI screens, p. 5-2
to read the complete procedure for capturing
screen images.
Help icon. A constant access icon. Reference
Areas of the GUI, p. 4-3. Drag this icon to the
item in question and release. A tooltip will appear
describing the items function.
Unread items icon. When this icon appears overlaid on another icon or tab (the logs icon, for
example) it indicates there are unread items at
this location.
Configure icon. A constant access icon. Reference Areas of the GUI, p. 4-3. Touch this icon to
display the configure screen. Tabs with SST
results, options, Comm setup, and date/ time
change are displayed.
Pause icon. Located above the constant access
icons. Touch this icon to pause the waveform
graph.
Waveform layout icon. Located above the constant access icons area.Touch this icon to open
the waveform layout dialog.
Operators Manual
2-19
Product Overview
Description
Grid lines icon. Located above the constant
access icons area. Touch this icon to turn waveform grid lines ON or OFF.
Maximize waveform icon. Located at the upper
right portion of each waveform. Touch this icon
to enlarge the waveform to its maximum size.
Restore waveform icon. Restores waveform to its
original size. Located at the upper right of the
maximized waveform.
Pushpin icon pinned state. When in the pinned
state, prevents a dialog from closing (under
certain conditions). Located in the upper right
corner of the GUI on the vent setup screen. Reference Pushpin Icon, p. 4-5.
Pushpin icon unpinned state. When the
unpinned icon is touched, the pinned state
becomes active. Located in the upper right corner
of the GUI on the vent setup screen. Reference
Pushpin Icon, p. 4-5.
Low priority alarm icon (appears on alarm banner).
Medium priority alarm icon (appears on alarm
banner).
High priority alarm icon (appears on alarm banner).
2.10.3
2-20
Operators Manual
Definition
TA
Apnea interval
DSENS
Disconnect sensitivity
CDYN
Dynamic compliance
RDYN
Dynamic resistance
EEF
PI END
LEAK
Exhalation leak
VTE MAND
VE TOT
VE SPONT
VTE SPONT
VTE
ESENS
Expiratory sensitivity
TE
Expiratory time
Flow pattern (ramp)
Flow pattern (square)
Operators Manual
VSENS
Flow sensitivity
V-TRIG
Flow triggering
PH
TH
TH:TL
I:E
C20/C
VLEAK
Inspiratory leak
TI
Inspiratory time
2-21
Product Overview
2-22
Symbol or Abbreviation
Definition
PI
Inspiratory pressure
VTI
VTL
PEEPI
PEEPI PAV
PL
TL
PMEAN
NIF
O2%
Oxygen percentage
P0.1
CPAV
EPAV
% Supp
RPAV
RTOT
WOBTOT
PPEAK
PEF
VMAX
PSF
PEEP
%Leak
Percent leak
PPL
Plateau pressure
TPL
Plateau time
PCOMP
Compensation pressure
Operators Manual
Definition
PSENS
Pressure sensitivity
PSUPP
P-TRIG
Pressure triggering
VTIY
VTEY
VTI MANDY
VTI SPONTY
VTLY
2.10.4
f/VT
TI SPONT
TI/TTOT
CSTAT
Static compliance
RSTAT
Static Resistance
VT
Tidal Volume
PEEPTOT
Total PEEP
fTOT
VC
Vital Capacity
VS
Volume support
Audible Indicators
A tone sounds when a button on the GUI is touched, and also when settings
are accepted. Audible indicators include pitched tones, beeps, and key clicks.
Key clicks sound whenever a key on the GUI is pressed. Various tones annunciate patient alarms.
Operators Manual
2-23
Product Overview
Note:
Pressing ALARM SILENCE mutes alarms for the two-minute alarm silence duration
period.
Caregivers may choose to silence alarms by pressing the ALARM SILENCE key.
A two-minute countdown timer appears on the GUI during the alarm silence
interval. Cancel the alarm silence function by touching Cancel.
Click each icon below to listen to a sample of the corresponding tones:
Note:
To hear the tones, Adobe Acrobat Reader version 10 or higher must be installed on
your computer. Get Adobe Acrobat Reader, free, here.
Table2-8.GUI Audible Indicator Functions
Function
2-24
Description
Operators Manual
The clinician enters ventilation parameters via the GUIs touch screen. Reference GUI Front View, p. 2-6. The keys activate other ventilator functions. Reference GUI Control Keys, p. 2-16.
2.11
2.11.1
Operators Manual
ON/OFF switch Lift the switch cover and turn the ventilator ON or OFF.
2-25
Product Overview
2-26
AC power indicator
ON/OFF switch
Service mode button Press and release this button when the Covidien splash
screen appears on the status display after powering on the ventilator to enter
Service mode. Reference Service Mode Button (TEST), p. 2-27. Reference Status
Display Indicators and Descriptions, p. 2-30 for an image of the splash screen.
Operators Manual
Note:
The Covidien splash screen shows the Covidien logo and appears momentarily as a
banner on the status display.
BDU AC Indicator
The status display and the AC power indicator are the only visual indicators on
the BDU. The AC indicator illuminates green whenever the ventilator is connected to AC power. All other visual indicators on the ventilator are on the
GUI. Reference Typical Status Display Indicators and Messages, p. 2-30 for a
description of the status display indicators and symbols. Reference the section
below for a summary of the information appearing on the status display.
Operators Manual
2-27
Product Overview
Status Display
The status display is a separate display located on the BDU. Reference BDU
Front View, p. 2-8, item 6. The status display provides the following information according to the state of the ventilator:
During normal ventilation the status display shows
Circuit pressure graph displaying pressure units, 2PPEAK alarm setting and current
PPEAK and PEEP values
Note:
The status display provides a redundant check of ventilator operation.If the GUI stops
operating for any reason, ventilation continues as set.
The figure below shows a sample of the status display during normal ventilation.
2-28
Operators Manual
Power status
Measured PEEP
Measured peak circuit pressure (updated at the end of the current breath)
Operators Manual
2-29
Product Overview
Meaning
Splash screen. Appears when the ventilators
power switch is turned on. When this image
appears, press and release the TEST button at the
back of the ventilator to enter Service mode.
2-30
Operators Manual
Meaning
Stand-by state. The status display appears as
shown when the ventilator is in stand-by state.
Operators Manual
2-31
Product Overview
Meaning
On battery power. Alerts the operator there is
insufficient AC power to operate the ventilator.
Ventilator is operating on battery power with
greater than ten minutes of capacity remaining.
Note the appearance of the battery icon.
Critically low battery. Identifies that the ventilators primary battery has less than five minutes of
battery capacity remaining. A percentage indicator shows the remaining battery capacity. If an
extended battery is installed, the image would
show a similar representation in the extended
battery location.
2-32
Operators Manual
Meaning
Battery inoperative. This image appears on the
status display when a battery fault renders the
battery inoperative.
Operators Manual
2-33
Product Overview
Meaning
Safety Valve Open (SVO) indicator. During SVO,
the patient can breathe room air through the
safety valve, to the extent the patient is able to
breathe unaided. Reference Safety Valve Open
(SVO), p. 4-36 for more information on the SVO
state.
2-34
Operators Manual
Description
2.11.2
Connectors
The ventilator incorporates the following connectors:
2.12
Exhalation port (From patient) port The expiratory limb of the patient
circuit attaches to the inlet of the expiratory bacteria filter. This port is compatible
with a standard 22mm (OD) conical connection.
Proximal Flow sensor A keyed pneumatic connector for the Proximal Flow
Sensor is provided with a locking feature to prevent inadvertent disconnection.
The proximal flow sensor measures flow and pressure at the patient wye. The
Proximal Flow Sensor is an optional sensor. Details on operation are provided in
the appendix in this manual. Reference Appendix F.
Special Features
A Proximal Flow option is available. The proximal Flow Sensor is used to
measure low flows and pressures associated with neonatal ventilation. If the
ventilator is configured with this option, Reference Appendix F for more information.
Operators Manual
2-35
Product Overview
2.13
Color Definitions
Reference the following figures to view the ventilators pneumatic diagram
during inspiration with various colors representing the gases as shown below.
Table2-11.Color Legend
Color or
Symbol
Description
High-pressure Oxygen (NFPA 99 designation)
Atmosphere
Vacuum
Water
2.14
Pneumatic Diagrams
The following figures illustrate the ventilators pneumatics with and without
the optional Proximal Flow System. The Proximal Flow System is only for use
with neonatal patients.
2-36
Operators Manual
Figure2-11.Pneumatic Diagram
Operators Manual
12
13
14
15
16
17
18
19
20
Humidifier
10
21
11
22
2-37
Product Overview
23
34
24
35
25
36
26
37
27
38
28
39
29
40
30
41
31
42
32
43
33
44
2-38
Operators Manual
Note:
Items enclosed by dotted line represent components internal to the ventilator.
Operators Manual
Humidifier
2-39
Running H/F 1
2-40
Running H/F 3
3 Installation
3.1
Overview
This chapter contains information for the installation and set up of the Puritan
Bennett 980 Series Ventilator. Before operating the ventilator system, thoroughly read this Operators Manual.
Topics include:
3.2
Safety reminders
Ventilator setup
Battery information
Safety Reminders
WARNING:
Explosion hazard Do not use in the presence of flammable gases. An
oxygen-rich environment accelerates combustibility.
WARNING:
To ensure proper operation and avoid the possibility of physical injury, only
qualified medical personnel should attempt to set up the ventilator and
administer treatment with the ventilator.
WARNING:
To prevent electrostatic discharge (ESD) and potential fire hazard, do not use
antistatic or electrically conductive hoses or tubing in or near the ventilator
breathing system.
3-1
Installation
3.3
3.3.1
WARNING:
Use only gas supply hoses approved by Covidien. Other hoses may be
restrictive and may cause improper ventilator operation.
WARNING:
To avoid possible injury, lock the ventilators casters prior to installing or
removing ventilator components.
Caution:
To ensure optimum performance, Covidien recommends preventive
maintenance be performed by factory-trained Biomedical Engineers per the
schedule specified. Reference Service Preventive Maintenance Frequency, p.
1-2 in the Operators Manual Addendum in this manual.
Note:
US federal law restricts this device to sale by or on the order of a physician.
Product Assembly
How to Assemble Ventilator Components
Ventilator setup should have already been completed by factory-trained service
personnel including successfully passing EST. This manual does not include
ventilator assembly instructions.
3.3.2
3-2
Operators Manual
Product Connectivity
WARNING:
Use only Covidien-branded batteries. Using other manufacturers brands
could result in the batteries operating the ventilator for less than the
specified amount of time or could cause a fire hazard.
WARNING:
One primary battery must be installed at all times in the BDUs primary
battery slot for proper ventilator operation. The ventilator will not complete
the startup process without the primary battery installed. Reference Battery
Compartment Locations, p. 3-21 for identification of battery slots.
Operators Manual
3-3
Installation
Battery Charging
Batteries requiring charging are charged whenever the ventilator is connected
to AC power, whether operating or not.
The ventilator charges its primary battery first, then its extended battery. The
time required to charge a single battery (either primary or extended) is approximately six hours at room temperature whether the ventilator is turned off (but
connected to AC power) or operating, but charging time can vary based on
temperature or depletion state of the battery. The status display provides the
batterys capacity.
Green LED bars located on the ends of both primary and extended batteries (if
installed) scroll upwards indicating battery charging. A white LED bar represents the battery is in use and a round LED indicator illuminates red if there
is a battery fault. When running on battery power, battery capacity is determined by the number of green LED bars illuminated. Reference Proper Battery
Orientation, p. 3-20 to view the LEDs. Reference p. 3-19 for information on
interpreting the battery capacity. Green LED bars do not scroll if the battery is
not charging or is in use.
If a battery fault occurs, the fault is annunciated, charging of the faulty battery
discontinues, but charging of any other non-faulty battery continues. A faulty
battery will cause annunciation of the error and battery power will not be available for the ventilator.
The ventilator status display indicates the charge level of the installed batteries,
the presence of one or more battery faults, and which battery is being charged.
The ventilator operates no differently when its batteries are charging than it
does when the batteries are fully charged.
The ventilator continues operating as set when the ventilator switches from AC
power to battery power and illuminates an indicator on the status display alerting the operator that the ventilator is now operating on battery power and AC
POWER LOSS alarm annunciates. A medium priority alarm annunciates when
the remaining run-time for the ventilator drops to ten (10) minutes and a high
priority alarm annunciates when the remaining time drops to five (5) minutes.
3.4
Product Placement
The ventilator is positioned standing on its casters next to the patients bedside, as shown below.
3-4
Operators Manual
Product Connectivity
Move the ventilator using the handle encircling the BDU and roll the ventilator
to the desired location.
Figure3-1.Example of Freestanding Ventilator Placement
3.5
3.5.1
Product Connectivity
Connecting the Ventilator to AC Power
Note:
Power outlet access and power cord position Ensure that the power outlet
used for the ventilator is easily accessible; disconnection from the outlet is the only
way to completely remove power from the ventilator.
To connect the power cord to AC power
1.
Plug the ventilator into a properly grounded power outlet rated for at least 15 A.
Operators Manual
3-5
Installation
2.
Verify the connection by checking the AC indicator below the power switch on
the front of the BDU. Reference Ventilator Power Switch and AC Indicator, p. 226 for the power switch and AC indicator locations.
Use the power cord hook located at the back of the ventilator for power cord
storage.
3-6
WARNING:
For proper ventilator operation, and to avoid the risk of electric shock,
connect the ventilator to a grounded, hospital grade, AC electrical outlet.
Operators Manual
Product Connectivity
3.5.2
Operators Manual
3-7
Installation
WARNING:
Due to excessive restriction of the Air Liquide, SIS, and Drger hose
assemblies, reduced ventilator performance levels may result when oxygen
or air supply pressures < 50 psi (345 kPa) are employed.
Gas cross flow from one high pressure input port of one type of gas to another
high pressure input port of a different gas will not exceed 100 mL/h under
normal or single fault conditions. If, during a single fault condition, cross flow
exceeds 100 mL/h, an audible alarm annunciates.
WARNING:
Use of only one gas source could lead to loss of ventilation and/or hypoxemia
if that one gas source fails and is not available. Therefore, always connect at
least two gas sources to the ventilator to ensure a constant gas supply is
available to the patient in case one of the gas sources fails. The ventilator has
two connections for gas sources: air inlet, and oxygen inlet. Reference Nontechnical Alarm Summary, p. 6-18 for alarms that occur due to a loss of either
gas supply.
To connect the gas sources
1.
Connect the oxygen hose to the oxygen inlet fitting (item 1) as shown. Ensure use
of a medical grade oxygen source.
2.
3-8
Connect the air hose to the air inlet fitting (item 2) Reference Connecting the Ventilator to the Gas Supplies, p. 3-9.
Operators Manual
Product Connectivity
O2 gas connection
WARNING:
To prevent a potential fire hazard and possible damage to the ventilator,
ensure the connections to the gas supplies are clean and unlubricated, and
there is no water in the supply gas. If water is suspected, use an external wall
air water trap to prevent damage to the ventilator or its components.
The ventilator system can be purchased with the following gas inlet fittings for
both air and O2: BOC, DISS, female, NIST, Air Liquide, SIS, and Drger.
Operators Manual
3-9
Installation
Reference Covidien Accessories and Options, p. 9-4 for part numbers of gas
hoses. For countries outside the USA, contact your local Covidien representative for the proper gas hoses.
3.5.3
Filter Installation
The ventilator is shipped with internal and external inspiratory filters. Reference
Covidien Accessories and Options, p. 9-4 for the part numbers of expiratory filters. To prevent infection and contamination, both inspiratory and expiratory
filters must be used with the ventilator.
WARNING:
In order to reduce the risk of infection, always use the ventilator with
inspiratory and expiratory bacteria filters.
WARNING:
Do not attempt to use inspiratory or expiratory filters designed for use with
ventilators other than the Puritan Bennett 980 Series Ventilator. Reference
Covidien Accessories and Options, p. 9-4 for relevant part numbers.
WARNING:
Refer to the filters instructions for use for details such as cleaning and
sterilization requirements, filtration efficiency, proper filter usage, and
maximum filter resistance, particularly when using aerosolized medications.
Caution:
Ensure both inspiratory and expiratory filters are properly attached to the
ventilator.
To install the inspiratory filter
1.
Attach the inspiratory filter to the To Patient port.
2.
3-10
Ensure the direction of flow arrow is pointing outward, toward the patient circuits inspiratory limb.
Note:
Refer to the inspiratory filter IFU for information on proper use and handling of
the filter.
Operators Manual
Product Connectivity
WARNING:
Refer to the expiratory filter instructions for use (IFU) for information on
reusable filter cleaning and sterilization and filter efficiency.
Note:
Refer to the expiratory filter IFU for information on proper use and handling of the
filter and for emptying the condensate vial for adult and pediatric patients. Reference
Appendix E for information on emptying the condensate vial when using neonatal
expiratory filters.
WARNING:
Do not re-use disposable inspiratory or expiratory filters, and dispose
according to your institutions policy for discarding contaminated waste.
The condensate vial must be assembled to the reusable expiratory filter prior
to installing the assembly to the ventilator.
To assemble the Adult/Pediatric reusable expiratory filter and condensate vial
1.
Seat the filter to the condensate vial, ensuring alignment of the condensate vials
seal with the mating edge of the expiratory filter.
2.
Twist the condensate vial in a counterclockwise direction until the stops on the vial
and expiratory filter meet.
Raise the expiratory filter latch to unlock (item 6).Reference Adult/Pediatric Filter
Installation, p. 3-12. This raises the exhalation valve assembly and allows the filter
door to swing away from the ventilator.
3.
4.
5.
Insert the new filter by sliding the filter along the tracks in the door. Ensure the
From Patient port aligns with the cutout in the door and points away from the
ventilator.
6.
7.
Operators Manual
3-11
Installation
WARNING:
Do not operate the expiratory filter latch during patient ventilation.
Opening the latch during ventilation will result in a patient disconnect
condition and corresponding alarm.
Figure3-4.Adult/Pediatric Filter Installation
Condensate vial
Expiratory filter
3-12
2.
Lift expiratory filter latch. Reference Installing the Neonatal Filter, p. 3-13 (item 3).
3.
Remove existing expiratory filter door by lifting it off of the pivot pins.
Operators Manual
Product Connectivity
4.
Note:
Unlike the pediatric/adult expiratory filter and condensate vial, the neonatal filter and
condensate vial assembly is provided assembled. The condensate vial is removable for
discarding accumulated liquid, by turning the vial clockwise to remove and
counterclockwise to install.
To install the neonatal expiratory filter assembly
1.
With the door still open, push the neonatal filter assembly straight up into the
adapter.
2.
3.
4.
Operators Manual
Attach the drain bag tube to the condensate vials drain port.
3-13
Installation
3.
Hang the drain bag on the holder located on the ventilators accessory rail, as
shown below. Reference Covidien Accessories and Options, p. 9-4 for part
number of drain bag holder.
Figure3-6.Drain Bag
3.5.4
3-14
Operators Manual
Product Connectivity
WARNING:
Use patient circuits of the lowest compliance possible with the ventilator
system to ensure optimal compliance compensation and to avoid reaching the
safety limit of five times set tidal volume or the compliance compensation
limit. Reference the table below for circuit types corresponding with
predicted body weight (PBW).
Table3-1.Patient Types and PBW Values
Circuit Type
PBW in kg (lb)
Neonatal
Not applicable
Pediatric
Adult
7.0 kg to 24 kg
(16 lb to 53 lb)
Note:
Refer to the patient circuits instructions for use (IFU) for information on proper use
and handling and care and maintenance of the circuit.
Operators Manual
3-15
Installation
3-16
Humidifier
Inspiratory limb
Expiratory filter
Circuit wye
To Patient port
Expiratory limb
Inspiratory filter
Condensate vial
Operators Manual
Product Connectivity
Humidifier
Circuit wye
To patient port
Inspiratory filter
Condensate vial
Operators Manual
3-17
Installation
3.6
3.6.1
3-18
WARNING:
Do not attempt to sterilize single-patient use circuits.
Operators Manual
Product Connectivity
Figure3-9.Ventilator Battery
Battery connector
Primary Batteries
The ventilators primary battery is located in the rearward battery receptacle on
the right side of the BDU. Reference Battery Compartment Locations, p. 3-21.
The primary battery may be hot swapped, that is it can be replaced while
the ventilator is operating.
To install or replace the primary battery in the BDU
1.
With the battery not installed in the ventilator, or if the ventilator is turned off and
not connected to AC power, check the charge level by pressing the charge level
button on the battery and verifying the charge level LEDs illuminate. Reference
Proper Battery Orientation, p. 3-20. for the location of the charge level button.
Five green LED segments illuminate, indicating 90% battery capacity. From
bottom to top, the first LED indicates 10% capacity, the second LED indicates
Operators Manual
3-19
Installation
25% capacity, the third LED indicates 50% capacity, and the fourth LED indicates 75% capacity. An illuminated red LED at the top of the battery indicates
a battery fault. If no LEDs illuminate it means there is < 10% battery capacity
remaining.
2.
If the charge level is sufficient, orient the battery as shown, Reference Proper
Battery Orientation, p. 3-20, face the front of the ventilator and locate the battery
compartments on the right side of the BDU. Reference Battery Compartment
Locations, p. 3-21. The receptacle towards the rear of the ventilator houses the
primary battery while the receptacle towards the front of the ventilator houses the
extended battery.
3.
The primary battery is fastened in place with a thumbscrew (item 3). Loosen the
thumbscrew approximately four to five turns to allow battery installation.
4.
Insert the battery and push into its receptacle all the way until it clicks, indicating
it is latched. The battery will only fit into the slot one way.
Figure3-10.Proper Battery Orientation
3-20
Operators Manual
Product Connectivity
Tighten the thumbscrew to secure the battery and prevent the primary battery
from being removed.
5.
Note:
Remove the primary battery by reversing the steps. After loosening the
thumbscrew, slide the battery ejector to the left to eject the battery.
Figure3-11.Battery Compartment Locations
Operators Manual
3-21
Installation
Extended batteries
The extended battery receptacle is located forward of the primary battery. Like
the primary battery, the extended battery may be hot swapped.
To install or remove an extended battery in the BDU
1.
Properly orient the battery as shown above.
2.
3-22
Push the battery into the forward receptacle in the BDU all the way until it clicks,
indicating the battery is latched. Reference Battery Compartment Locations, p. 321.
Note:
Remove the battery by sliding the battery ejector to the left. The battery ejects
itself from its receptacle. There is no thumbscrew for extended batteries.
WARNING:
Even though the Puritan Bennett 980 Ventilator meets the standards
listed in Chapter 11, the internal Lithium-ion battery of the device is
considered to be Dangerous Goods (DG) Class 9 - Miscellaneous, when
transported in commerce. As such, the Puritan Bennett 980 Ventilator and/
or the associated Lithium-ion battery are subject to strict transport
conditions under the Dangerous Goods Regulation for air transport (IATA:
International Air Transport Association), International Maritime
Dangerous Goods code for sea and the European Agreement concerning
the International Carriage of Dangerous Goods by Road (ADR) for Europe.
Private individuals who transport the device are excluded from these
regulations although for air transport some requirements may apply.
WARNING:
To avoid the risk of fire, explosion, electric shock, or burns, do not short
circuit, puncture, crush, heat above 60C, incinerate, disassemble the
battery, or immerse the battery in water.
Note:
Reference Battery Charging, p. 3-4 for battery charging information when
batteries are installed in ventilator.
Operators Manual
Product Connectivity
3.6.2
Battery Testing
To test the batteries
1.
Push the battery charge level button located on the battery. A series of LEDs illuminates, indicating the charge level of the battery. When the bottom LED is illuminated, there is 10% of full battery capacity. The next LED illuminates when
there is 25% capacity. the third lamp illuminates when there is 50% capacity
available. The fourth LED illuminates when there is 75% capacity, and when the
top LED is illuminated, it represents 90% capacity. Reference Proper Battery Orientation, p. 3-20 to view the battery test button and LEDs.
3.6.3
Operators Manual
Ventilator settings
PEEP = 8 cmH2O
3-23
Installation
3-24
PEEP = 35 cmH2O
Operators Manual
Product Connectivity
The run time does not vary significantly between typical and heavy load settings. The ventilator can be expected to run approximately 75 minutes at
typical settings with new batteries. When running batteries nearing end of life
(batteries with 1000 charge/discharge cycles were used for this data) the run
time can be expected to be approximately 55 minutes.
3.6.4
Battery Life
Battery life for both primary and extended batteries is approximately three (3)
years. Actual battery life depends on the history of use and ambient conditions.
As the batteries age with use, the time the ventilator will operate on battery
power from a fully charged battery will decrease. Replace the battery every
three (3) years or sooner if battery operation time is insufficient for your usage.
3.6.5
Battery Disposal
The battery is considered electronic waste and must be disposed of according
to local regulations. Follow local governing ordinances and recycling plans
regarding disposal or recycling of the battery.
3.6.6
Flex Arm
Use the flex arm to support the patient circuit between the patient and the
ventilator. Reference Flex Arm Installation, p. 3-26, which illustrates flex arm
installation into the sockets provided.
Operators Manual
3-25
Installation
3-26
2.
3.
Hang the patient circuit using the circuit management supports included with the
flex arm.
4.
Remove the flex arm by first removing the patient circuit, then un-fastening the
flex arm from the threaded fastener in the handle.
Operators Manual
Product Connectivity
3.6.7
Humidifier
Use the humidifier to add heat and moisture to the inhaled gas. Connect the
humidifier to a hospital grade electrical outlet. Choose the humidifier (type and
volume appropriate for the patient). The humidifier may be mounted with the
humidifier bracket as shown. Reference Covidien Accessories and Options, p.
9-4 for the part number of the humidifier bracket.
WARNING:
Selection of the incorrect humidifier type and/or volume during SST or during
patient ventilation can affect the accuracy of delivered volume to the patient
by allowing the ventilator to incorrectly calculate the compliance correction
factor used during breath delivery. This can be a problem, as the additional
volume required for circuit compressibility compensation could be incorrectly
calculated, resulting in over- or under-delivery of desired volume.
WARNING:
To ensure proper compliance and resistance calculations, perform SST with
the humidifier and all accessories used for patient ventilation installed in the
ventilator breathing system.
WARNING:
Follow the humidifier manufacturers Instructions for Use (IFU) when using a
humidifier with patient ventilation.
Caution:
Follow humidifier manufacturers instructions for use (IFU) for proper
humidifier operation.
To install the humidifier bracket
1.
Attach humidifier bracket to the ventilators accessory rail by placing the bracket
behind the railing and fastening the bracket clamp to the bracket with four (4)
5/32 inch hex screws, capturing the railing between the bracket and the clamp.
Ensure the humidifier mounting slots are facing outward from the ventilator.
Operators Manual
3-27
Installation
3-28
Operators Manual
Product Connectivity
2.
3.
Install the chamber to the humidifier, connect the patient circuit, then run SST.
Operators Manual
3-29
Installation
3.7
3.7.1
4.
5.
Note:
Complete instructions for the humidifier bracket and humidifier installation are given
in the Puritan Bennett 980 Series VentilatorHumidifier Bracket Installation
Instructions, which includes humidifier bracket part numbers and descriptions.
3.7.2
Quick Start
Quick Start is an extension of Normal mode, where institutionally configured
default settings are applied after the patients PBW or gender and height are
entered and Quick Start is touched to begin ventilation.
3-30
Operators Manual
Product Connectivity
3.7.3
Stand-By State
Stand-By state can be used when the clinician needs to disconnect the patient
for any reason (prior to a suction procedure, for example). The ventilator enters
Stand-By state if a request is made by the clinician, a patient is disconnected
within a fixed time period determined by the ventilator software, and the clinician confirms the patient has been disconnected intentionally. If a patient
becomes disconnected from the patient circuit after the time period elapses,
an alarm sounds and the patient-disconnect sequence is initiated. In Stand-by
state, gas output is reduced to ten (10) L/min to limit gas consumption and to
allow for detection of patient reconnection, and O2 concentration becomes
100% for adult and pediatric circuit types and 40% for neonatal circuit types.
Stand-by state is available in all ventilation modes except during Inspiratory and
Expiratory BUV, Occlusion Status Cycling (OSC), Safety Valve Open
(SVO), or Ventilator Inoperative (Vent Inop) conditions.
Note:
Do not block patient circuit wye while in Stand-By state. If the wye is blocked, the
ventilator detects a patient connection and will attempt to resume normal ventilation.
To enter Stand-By state
1.
Touch the Menu tab on the left side of the GUI. The menu appears.
2.
Touch Stand-By. A Stand-By state pending dialog appears instructing the clinician
to disconnect the patient circuit. A timer starts which allows 30 s to disconnect
the patient.
3.
Disconnect the patient circuit and confirm the disconnection by touching Confirm.
A timer starts which allows 30 s for confirmation of disconnect.
Operators Manual
3-31
Installation
Ventilator settings can be changed, if desired, and will be applied upon patient
reconnection.
The ventilator displays an indicator that it is in Stand-by State, and a timer indicating the elapsed time the ventilator has been in Stand-by state.
3-32
Operators Manual
Product Connectivity
3.7.4
Service Mode
WARNING:
Before entering Service Mode, ensure a patient is not connected to the
ventilator. Ventilatory support is not available in Service Mode.
Service Mode is used for Extended Self Test (EST), ventilator calibration, configuration, software upgrades, option installation (all of which must be performed by Covidien factory-trained service personnel), and for making
adjustments to institutional settings. All information stored in the individual
logs is available in Service Mode. Service Mode logs include:
Settings Log
Alarms Log
Service log
Reference the Puritan Bennett 980 Series Ventilator Service Manual for
details about Service Mode logs.
A patient must not be attached to the ventilator when entering Service Mode.
Specific actions must be performed to enter this mode, prior to POST completion.
To access Service Mode
1.
Remove the ventilator from patient usage.
2.
3.
Press and release the Service Mode button (TEST) at the back of the ventilator,
when the Covidien splash screen appears on the status display after powering on
the ventilator. Reference Service Mode Button (TEST), p. 3-34. Reference Status
Display Indicators and Descriptions, p. 2-30 for an image of the splash screen. The
ventilator prompts to confirm no patient is attached.
Operators Manual
3-33
Installation
4.
5.
Confirm a patient is not connected to the ventilator by touching the corresponding button. The message SERVICE MODE VENTILATION SUPPORT IS NOT AVAILABLE appears on the graphical user interface.
6.
7.
Reference the Puritan Bennett 980 Series Ventilator Service Manual for
information on which keys are disabled during EST.
In addition to allowing SST to be run, Service Mode also allows configuration
of various items. Reference Ventilator Configuration, p. 3-35 for a list of institutionally- and operator-configurable items.
3-34
Operators Manual
Product Connectivity
3.8
Product Configuration
The ventilator is shipped configured with factory defaults for new patient
parameters which can be configured to suit institutional preferences. The
operator may configure any desired parameter as long as this option has not
been locked out and rendered unavailable. When configuring the ventilator, it
displays the parameters associated with the operators last configuration. The
following table lists the factory-configured settings, the institutionally-configurable settings, and the operator-configurable settings.
WARNING:
If the ventilator fleet in your institution uses multiple institutionally
configured presets and/or defaults, there can be risks of inappropriate alarm
settings.
Table3-2.Ventilator Configuration
Feature
Factory Configured
Institutionally Configurable
Operator
Configurable
Vital patient
data banner
Large font
patient data
panel
Waveform
layout
Display
brightness
(Light settings)
Alarm volume
Elevate O2
control
Date/time
format
Default mL/kg
ratio
Operators Manual
Configured
by Circuit
Type
User Lockable
X
Cant be
changed in
Normal mode
3-35
Installation
Table3-2.Ventilator Configuration
Feature
3-36
Factory Configured
Institutionally Configurable
New patient
startup
defaults
(including
PBW, vent
type, mode,
mandatory
type, trigger
type, O2%,
elevate O2)
Opacity
Operator
Configurable
Configured
by Circuit
Type
User Lockable
Operators Manual
Product Connectivity
3.8.1
Caution:
Do not lean on the GUI or use it to move the ventilator. Doing so could break
the GUI, its locking mechanism, or tip the ventilator over.
Mode.
2.
Touch Configuration at the top of the screen in Service Mode. A list of buttons
appears allowing configuration of the corresponding parameters.
3.
Reference the sections below for specific instructions on institutional configuration of each parameter.
3.8.2
2.
Touch Configuration at the top of the screen in Service Mode. A list of buttons
appears allowing configuration of the corresponding parameters.
3.
Select the desired modified setting from the left-hand menu options.
4.
Touch Default.
Operators Manual
3-37
Installation
The settable date corresponds to the number of days in the set month and
accounts for leap years.
To institutionally configure the ventilators date and time settings
1.
Enter Service Mode, and confirm no patient is attached by touching Configuration. Reference Service Mode, p. 3-33 for instructions on entering Service
Mode.
3-38
2.
3.
4.
Touch Hour and turn the knob to enter the correct hour.
5.
6.
7.
8.
Operators Manual
Product Connectivity
Pressure Units
The ventilators pressure units can be configured for hPa or cmH2O.
To institutionally configure pressure units
1.
Enter Service Mode, and confirm no patient is attached by touching Configuration. Reference Service Mode, p. 3-33 for instructions on entering Service
Mode.
2.
3.
4.
Mode.
2.
Touch Light Settings. Sliders appear to adjust the screen brightness and keyboard
backlight.
3.
Move the sliders to increase or decrease the brightness and backlight levels. Alternatively, turn the knob to increase or decrease the brightness and backlight levels.
4.
5.
Slide the brightness slider or turn the knob to adjust the brightness level.
3.
Dismiss the slider by touching anywhere on the GUI screen or allow to time out in
five (5) s.
Operators Manual
3-39
Installation
Touch the Vent type, Mode, Mandatory type, and Trigger type buttons corresponding to the desired parameters.
6.
Configure the default PBW and mL/kg ratio, Elevate O2 and O2% by touching its
button and turning the knob.
7.
8.
9.
Elevate O2
Note:
The Elevate O2 control adds a percentage of O2 to the breathing mixture for two
minutes. The additional percentage is shown on the icon in the constant access icon
area. The allowable range is 1% to 100%.
To adjust the amount of elevated O2 delivered for two minutes
1.
In the vent setup dialog in Normal mode, touch the Elevate O2 icon in the constant
access icons area of the GUI screen. The icon glows and a dialog appears with a
countdown timer, Elev O2 button highlighted and ready for changes, and Extend,
Stop, and Close buttons.
2.
Turn the knob to increase or decrease the amount of oxygen by the amount
shown on the button. The allowable range is +1% to +100% oxygen.
3.
Touch Extend to extend the two-minute interval. Touching Extend restarts the
two-minute countdown timer.
4.
Touch Stop to stop additional oxygen from being delivered and dismiss the countdown timer.
3-40
Operators Manual
Product Connectivity
If the current O2 setting is 80% or above and the selected delivery increment is
> 20%, the ventilator will deliver 100% O2 for two (2) minutes, after which the
oxygen sensor will be calibrated as long as the full two-minute interval elapses
without a change in O2 delivery.
If apnea ventilation occurs during the two-minute interval, the apnea % O2 delivery also increases by the configured amount.
During LOSS OF AIR SUPPLY or LOSS OF O2 SUPPLY alarm conditions, the Elevate
O2 function is canceled if in progress, and is temporarily disabled until the alarm
condition no longer exists.
During Safety PCV, the Elevate O2 control has no effect. During circuit disconnect
and stand-by states (when the ventilator is turned on but not ventilating) the
Elevate O2 function affects the currently delivered oxygen concentration, not the
set oxygen concentration.
Alarm Volume
WARNING:
The audio alarm volume level is adjustable. The operator should set the
volume at a level that allows the operator to distinguish the audio alarm
above background noise levels.
To institutionally configure the alarm volume
1.
Enter Service Mode, and confirm no patient is attached by touching Configuration. Reference Service Mode, p. 3-33 for instructions on entering Service
Mode.
2.
3.
Slide the alarm slider for each circuit type (adult, pediatric, or neonatal) or turn the
knob to configure the alarm volume. The volume settings range from 1 (minimum)
to 10 (maximum).
4.
Operators Manual
3-41
Installation
Note:
A sample alarm tone sounds for verification at each volume level change. If
necessary, re-adjust the alarm volume by moving the alarm volume slider to
increase or decrease the volume.
Note:
The alarm volume reverts to the institutionally configured default alarm volume or
factory default if the ventilators power is cycled.
2.
Dismiss the slider by touching anywhere on the GUI screen or allow to time out in
five (5) seconds.
Mode.
3-42
2.
Touch Patient Data Defaults. Five (5) layout preset buttons appear along with a list
of parameters and descriptions.
3.
Touch a preset button and individually select a parameter from the scrollable list
below to appear in that presets vital patient data banner. Use the right- and leftpointing arrows to configure default values for all available parameters.Additionally, touch the padlock icon above each patient data parameter on the data
banner to allow (unlocked) or restrict (locked) operator configurablity of that
parameter during normal ventilation.
Operators Manual
Product Connectivity
4.
When done configuring the selected preset, touch Accept and select another
preset to configure, if desired.
5.
6.
3.
Remaining user selected patient data values (up to 14, including waveforms and
loops)
Mode.
2.
Touch Large Font Patient Data Defaults. Five layout presets appear along with a
list of parameters and descriptions.
3.
Touch a preset button and individually select a parameter for each of the desired
patient data values.
4.
Choose the desired scalar and loop waveforms for the large font patient data display. Waveform thumbnails appear in the three right-most cells of the large font
data panel.
5.
Touch any of the padlock icons along the right-most edge of the selected layout
to prevent operator configurability of the selected row.
Operators Manual
3-43
Installation
6.
7.
8.
Swipe the additional patient data banners tab downward or touch the additional
patient data banners tab. Patient data appear in a larger font.
3.
Swipe the large font patient data panel tab upward or touch the tab to return to
the banner to its normal font size.
The large font patient data parameters are configured in the same way as
described in the patient data configuration section above.
Waveforms
Green waveforms denote a mandatory inspiration, yellow waveforms denote
exhalation, and orange waveforms denote a spontaneous inspiration.
The GUI can be configured to display up to three waveforms and two loops
simultaneously in the waveform area. Reference Areas of the GUI, p. 4-3. The
allowable waveforms include flow vs. time, pressure vs. time, volume vs. time,
and PSYNC vs. time (if IE Sync is installed and in IE Sync Monitoring). Reference
Appendix C for more information on IE Sync. Allowable loops include pressure
vs. volume and flow vs. volume. The waveforms display 60 seconds of information and can be shown in a redrawing format, or paused with the ability to
enable a cursor to trace the waveform by turning the knob.
To institutionally configure waveforms and loops
1.
Enter Service Mode, and confirm no patient is attached by touching Configuration. Reference Service Mode, p. 3-33 for instructions on entering Service
Mode.
3-44
2.
Touch Graph Defaults. Five (5) layout presets appear along with a list of parameters and descriptions.
3.
Touch a layout preset button. The parameter(s) button outline glows, signifying
that it can be changed. If more than one parameter can be changed, touch that
parameter to make its outline glow.
Operators Manual
Product Connectivity
4.
Select the parameter from the list whose waveform is desired to appear on the
waveforms screen.
5.
6.
Touch the padlock icon above each graphic layout to prevent operator configuration of the selected layout.
7.
8.
Touch the desired waveform(s) icon to display. The selected waveform(s) appear
on the GUI screen and the dialog closes.
Turn the knob to change the value. For each axis, turn the knob to the right to
decrease the values, and turn to the left to increase the values.
To pause waveforms
1.
Touch the pause icon, located below the waveforms area. The icon glows yellow
and allows the breath to complete. A cursor appears and travels along the waveform while turning the knob, displaying the x- and y-axis values.
2.
Mode.
2.
3.
Operators Manual
3-45
Installation
4.
Touch the padlock icon at the right side of the screen to allow or prevent operator
adjustment of the screen opacity.
5.
3.9
Note:
The opacity icon can be found on the vent setup screen and on any of the respiratory
mechanics maneuvers screens.
Installation Testing
Fully charge the batteries before placing the ventilator into clinical use. Reference Battery Charging, p. 3-4 for information on battery charging. Reference
p. 3-19 for the meaning of battery charge status LEDs and Reference p. 3-20
for the location of battery test switch and status LEDs.
Prior to connecting a patient to the ventilator for the first time, a qualified
service technician must have calibrated the ventilators exhalation valve, flow
sensors, and atmospheric pressure transducer and performed and successfully
passed EST. Reference the Puritan Bennett 980 Ventilator Service Manual for
instructions.
In addition, the clinician must also perform SST.
3.9.1
3-46
Operators Manual
Product Connectivity
WARNING:
When changing any accessories in the patient circuit or changing the patient
circuit itself, run SST to check for leaks and to ensure the correct circuit
compliance and resistance values are used in ventilator calculations.
When a patient is not attached to the ventilator, run SST to check the patient
circuit for:
Gas leaks
SST is a five-minute test and must be run under any of the following conditions:
When adding or removing accessories to the breathing system such as a humidifier or water trap
No external test equipment is required, and SST requires minimal operator participation.
Humidification type and volume can be adjusted after running SST, however
the ventilator makes assumptions when calculating resistance and compliance
if these changes are made without re-running SST. For optimal breath delivery,
run SST after changing humidification type and humidifier volume.
SST results are recorded in the SST results log, viewable in Service mode and in
Normal mode using the configuration (wrench) icon.
Required Equipment
Operators Manual
3-47
Installation
Humidifier, if applicable
Two gas sources (air and oxygen) connected to the ventilator) at a pressure
between 35 psi and 87 psi (241.3 kPa and 599.8 kPa
3-48
2.
So that the ventilator does not detect a patient connection, ensure that the
breathing circuit wye is not attached to a test lung or covered in any way that
would cause an increase in pressure at the wye.
3.
Turn the ventilator on using the power switch located at the front of the BDU,
below the status display. The ventilator runs POST when the power switch is
turned on. Ensure the ventilator is operating on full AC power. Otherwise, SST test
failures may result.
4.
Wait at least 15 minutes to allow the ventilator to warm up and stabilize to ensure
accurate results.
5.
At the ventilator startup screen, touch SST or the Configure icon (wrench) displayed in the lower right area of the GUI. The SST history log appears along with
Patient Setup, Run Leak Test, and Run All SST buttons.
6.
Connect the patient circuit, filters, condensate vial, and all accessories to be used
in patient ventilation. Ensure the patient wye is not blocked.
7.
Touch Run All SST to perform all SST tests or touch Run Leak Test to perform the
SST Leak test of the ventilator breathing circuit.
8.
9.
After accepting, touch the Circuit Type button corresponding to the patient circuit
type used to perform SST and to ventilate the patient (adult, pediatric, or neonatal.
10.
Operators Manual
Product Connectivity
11.
12.
Follow the prompts. Certain SST tests require operator intervention, and will
pause indefinitely for a response. Reference Individual SST Results, p. 3-51 for a
summary of the SST test sequence and results.
13.
After each test, the ventilator displays the results. If a particular test fails, the test
result appears on the screen and a choice to repeat the test or perform the next
test is given. When all of the SST tests are complete, the SST status screen displays
the individual test results.
14.
To proceed to patient set up, (if SST did not detect an ALERT or FAILURE) touch
EXIT SST, then touch Accept or cycle the ventilators power.
Function
Checks for inspiratory and expiratory limb occlusions, and calculates and stores the inspiratory and expiratory limb resistance
parameters.
Note:
The humidifier volume setting entered during SST should always be equal to the
chambers or columns empty compressible volume. Please do not enter either the
containers compressible volume when full or the containers water volume when full.
Operators Manual
3-49
Installation
For humidifier containers not listed, please enter the manufacturers published
compressible volume-empty (column A) value during SST.
Table3-4.Humidifier Volumes
Model
Description
(A)
Published Compressible
Volume-Empty
(mL)
Humidifier
Volume Setting
for SST (mL)
MR225
300
300
MR290
380
380
MR250
Adult, Disposable,
Manual Feed
480
480
MR210
Adult, Disposable,
Manual Feed
480
480
MR370
Adult, Reusable,
Manual Feed
725
725
MR340E
Infant, Reusable,
Manual Feed
310
310
Teleflex (Concha)
382-60
Standard compliance
296
296
Teleflex (Concha)
382-30
Low compliance
300
300
Teleflex (Concha)
385-40
Minimal compliance
164
164
Manufacturer
SST Results
SST reports results for each individual test.Three status indicators identify the
SST results and actions to take for each.
3-50
Alert Alerts occur when the ventilator detects one or more non-critical faults.
Fail The individual SST test did not meet its requirements.
Operators Manual
Product Connectivity
Meaning
Response
PASS
ALERT
FAIL
Repeat Test
Next Test
Exit SST
SST Outcomes
WARNING:
Choose to override the ALERT status and authorize ventilation only when
absolutely certain this cannot create a patient hazard or add to risks arising
from other hazards.
Meaning
Response
PASS
ALERT
FAIL
Operators Manual
3-51
Installation
SST did not detect any failures or alerts before the interruption, and
there were no changes to the circuit type at the start of the interrupted SST.
During SST, the ventilator displays the current SST status, including the test
currently in progress, results of completed tests. Test data are available in
Service Mode where applicable or are displayed on the screen. The ventilator
logs SST results, and that information is available following a power failure.
The alarm silence and alarm reset keys are disabled during SST, as well as the
Manual Inspiration, Inspiratory Pause, and Expiratory Pause keys.
3.9.2
Note:
SST is not part of the EST test suite. To determine patient circuit resistance and
compliance, run SST.
3-52
1.
Collect all required equipment prior to performing any self test of the ventilator.
Successful self test is not possible without the use of the listed equipment.
2.
3.
Operators Manual
Product Connectivity
4.
Connect the ventilator to AC power using the hospital-grade power cord until
completion of any self test.
5.
6.
Ensure both air and oxygen sources register pressure between 35 and 87 psi (241
to 599 kPa).
Note:
15. While in the Service Mode, normal ventilation is not allowed.
WARNING:
Always disconnect the ventilator from the patient before running EST.
Running EST while the ventilator is connected to the patient can injure the
patient.
WARNING:
A fault identified during this test indicates the ventilator or an associated
component is defective. Rectify the fault and perform any required repairs
prior to releasing the ventilator for patient use, unless it can be determined
with certainty that the defect cannot create a hazard for the patient, or add
to the risks which may arise from other hazards.
During EST, the ventilator displays the current EST status, including the test
currently in progress, results of completed tests, and measured data (where
applicable). The ventilator logs EST results, and that information is available following a power failure. The ventilator disables several offscreen keys located
on the bezel of the GUI during EST.
Operators Manual
Alarm silence
3-53
Installation
Alarm reset
Manual inspiration
Inspiratory pause
Expiratory pause
3.9.3
Note:
Attempts to run EST with a Neonatal filter can cause some EST tests to fail.
Note:
If using Air Liquide*, Drger*, and SIS air/oxygen hose assemblies, certain EST
tests may fail when using supply pressures less than50 psi (345 kPa) based on
excessive hose restriction.
3-54
2.
3.
Operators Manual
Product Connectivity
4.
Verify all three CALIBRATION tests under the CALIBRATION tab have passed.
5.
Touch the SELF TEST tab from the horizontal banner at the top of the monitoring
screen.
6.
7.
Touch Run All to run all tests in sequence or select the desired individual test.
8.
Choose one of the available options: touch Accept to continue; touch Cancel to
go back to the previous screen; or touch Stop to cancel EST.
9.
Follow the prompt to remove the inspiratory filter and connect the gold standard
circuit.
10.
Touch Accept.
11.
Follow prompts to complete EST. The EST tests require operator intervention, and
will pause indefinitely for a response. Reference EST Test Sequence, p. 3-54.
12.
13.
At the CONNECT AIR AND O2 prompt, connect both high pressure air and oxygen
sources.
14.
Touch Run All or select the desired individual test. After each test, the ventilator
displays the results.
15.
If a particular test fails, either repeat the test or perform the next test.
16.
When all of the EST tests complete, review test results by pressing each individual
test listed on the left side of the GUI.
17.
18.
Touch ACCEPT. The ventilator reruns POST and then displays the ventilator startup
screen.
Operators Manual
Function
Tests inspiratory and expiratory pressure transducers
and flow sensors at ambient pressure.
Required User
Interaction
Follow prompts
3-55
Installation
3-56
Function
Required User
Interaction
Leak Test
Follow prompts
Mix Leak
Follow prompts
Mix PSOL
None
Mix Accumulator
None
Circuit Pressure
Cross-checks safety valve, inspiratory and expiratory pressure transducers at various pressures
None
None
Delivery PSOL
None
Exhalation Valve
(EV) Loopback
None
Exhalation Valve
(EV) Pressure Accuracy
None
Exhalation Valve
(EV) Performance
Verifies the exhalation valve operates within specifications of the last exhalation valve calibration.
None
Exhalation Valve
(EV) Velocity Transducer
None
Safety System
None
Backup Ventilation
None
Communication
None
Internal Storage
None
LCD Backlight
None
Operators Manual
Product Connectivity
3.9.4
Function
Required User
Interaction
None
GUI Audio
Follow prompts
BD Audio
Follow prompts
Follow prompts
Follow prompts
Ventilator Battery
Follow prompts
Meaning
Response
PASS
ALERT
FAIL
Select:
REPEAT TEST,
NEXT TEST, or
STOP,
then touch ACCEPT.
NEVER RUN
Operators Manual
3-57
Installation
Meaning
Response
PASS
ALERT
FAIL
OVERRIDDEN
3.10
WARNING:
Choose to override the ALERT status and authorize ventilation only when
absolutely certain this cannot create a patient hazard or add to risks arising
from other hazards.
Operation Verification
Before ventilating a patient, you must perform SST and alarms tests with
passing results. Reference To run SST, p. 3-48 and Reference Alarm Testing,
p. 6-9 as well.
3-58
Operators Manual
4 Operation
4.1
Overview
This chapter describes Puritan Bennett 980 Series Ventilator operation and
includes the following sections:
4.2
Ventilator Function
Air and oxygen from wall sources or cylinders enter the ventilator and flow
through individual oxygen and air flow sensors. The gases are then mixed in the
mix modules accumulator. A pressure-relief valve in the mix modules accumulator prevents over-pressurization. The mix module also contains an oxygen
sensor which monitors the air-oxygen mixture according to the operator-set
O2% setting.
After the gas mixes, it flows to the inspiratory pneumatic system, where the
breath delivery flow sensor measures the gas flow and controls a PSOL valve
for proper breath delivery tidal volumes and pressures. The inspiratory pneumatic system contains a safety valve to avoid over-pressure conditions before
flowing through bacteria filters to the patient through the inspiratory limb of
the patient circuit. Upon exhalation, gas flows out the patient circuit expiratory
limb, through the expiratory bacteria filter, through the exhalation valve,
4-1
Operation
which includes the exhalation valve flow sensor, and through the exhalation
port.
4.3
Ventilator Setup
WARNING:
To avoid interrupted ventilator operation or possible damage to the
ventilator, always use the ventilator on a level surface in its proper
orientation.
To set up the ventilator
1.
Connect the ventilator to the electrical and gas supplies. Reference Power Cord
Retainer on BDU, p. 3-7 and Reference Connecting the Ventilator to the Gas Supplies, p. 3-9.
4.4
2.
Connect the patient circuit to the ventilator. Reference the figures on p. 3-16 and
p. 3-17 to connect the adult/pediatric or neonatal patient circuits, respectively.
3.
Turn the ventilator ON using the power switch. Reference Ventilator Power Switch
and AC Indicator, p. 2-26.
4.
Before ventilating a patient, run SST to calculate the compliance and resistance
with all items included in the patient circuit. Reference To run SST, p. 3-48.
4-2
Circuit pressure graph displaying PPEAK, PEEP, and pressure-related alarm settings
Operators Manual
Ventilator Shutdown
Reference Status Display, p. 2-28 for information about displayed items during
Service mode.
Caution:
Do not lean on the GUI or use it to move the ventilator. Doing so could break
the GUI, its locking mechanism, or tip the ventilator over.
1.
Note:
A soft bound is a selected value that exceeds its recommended limit and requires
acknowledgment to continue. Hard bounds have minimum and maximum limits
Operators Manual
4-3
Operation
beyond which values cannot be selected, however if the desired value is equal to
a settings hard bound, then it is allowable.
2.
Menu tab Located on the left side of the GUI screen. Swiping the tab to the
right and touching Setup causes the Vent, Apnea, Alarm, and More Settings tabs
to appear. Touching those tabs opens screens so that changes to ventilator settings, apnea settings and alarm settings can be made.
3.
Waveform area Located in the center of the GUI screen. Shows various
breath waveforms. Reference To configure waveforms and loops, p. 3-45 for
information on how to configure graphics.
4.
Breath Phase Indicator During normal ventilation, the GUI displays a breath
indicator in the upper left corner which shows the type of breath [Assist (A), Control
(C), or Spontaneous (S)] currently being delivered to the patient, and whether it is in
the inspiratory or expiratory phase. The breath indicator is updated at the beginning
of every inspiration, and persists until the next breath type update. During inspiration,
assist (A) and control (C) breath indicators glow green and spontaneous (S) breath indicators glow orange, each appearing in inverse video where the indicator appears black
surrounded by the colored glow. Reference Areas of the GUI, p. 4-3. During the expiratory phase the breath indicators appear as solid colors (green during assist or control
breaths and orange during spontaneous breaths).
5.
Vital Patient data banner Located across the top of the GUI screen. The
patient data banner displays monitored patient data and can be configured to
show desired patient data. Reference Vital Patient Data, p. 3-42 for information
on configuring patient data for display.
6.
Alarm banners Located on the right side of the GUI screen. Indicates to the
operator which alarms are active, and shown in a color corresponding to priority
(high is red and flashing, medium is yellow and flashing, low is yellow and steady).
7.
Constant access icons Located at the lower right of the GUI screen. This area
allows access to home (house), configure (wrench), logs (clipboard), elevate
oxygen percentage (O2), and help (question mark) icon. These icons are always
visible regardless of the function selected on the GUI.
8.
Constant access area Consists of the Current Settings area and the Constant
access icons. This area allows access to any of the patient setup variables shown
in these areas. Touching an icon causes the particular menu for that variable to
appear.
9.
Current settings area Located at the lower center of the GUI screen. The
ventilators current active settings display here. Touching any of the current settings buttons causes a dialog to appear, allowing changes using the knob.
10.
Vent Setup Button Located at the lower left of the GUI screen. Touching this
button allows access to the ventilator setup screen.
4-4
Operators Manual
Ventilator Shutdown
Screen Opacity
The opacity control enables the operator to adjust the opacity of the displayed
information between 50% and 100%. At 50%, the displayed image is semitransparent, and at 100%, the displayed image is opaque. The opacity value
remains as set if power is cycled and if the same patient is ventilated. If a new
patient is ventilated, the opacity defaults to 85%. Reference To adjust the
screen opacity, p. 3-46 for instructions on adjusting this feature.
Pushpin Feature
The pushpin feature prevents a dialog from closing under certain conditions
when it is pinned. Like the opacity control, the pushpin appears on the settings
screen after a new patient starts ventilation.
Figure4-2.Pushpin Icon
1
1
2
2
Display Brightness
Display brightness can be controlled manually.This feature is institutionally
configurable. Reference Screen Brightness and Keyboard Backlight (Light Settings), p. 3-39. The brightness range is from 1% to 100% with 1% resolution.
The default value is 80%.
To manually adjust display brightness
1.
Press the display brightness key.
2.
Operators Manual
Slide the brightness slider to the right to increase the brightness level or to the left
to decrease the brightness level. Alternatively, turn the knob to increase or
decrease the brightness level. The control disappears from the screen in approximately five (5)seconds.
4-5
Operation
Display Lock
The primary display provides a display lock key to prevent inadvertent changes
to settings. When active, the display lock disables the touch screen, knob, and
off-screen keys (other than the display lock key) and illuminates an LED on the
display bezel. An image of the display lock icon appears transparently over anything displayed on the GUI, should the operator attempt to use the GUI. Any
new alarm condition disables the display lock and enables normal use of the
GUI.
To lock and unlock the display
1.
Press the display lock key on the GUI. The keyboard LED illuminates and a transparent locked icon appears on the screen, indicating display lock. The icon shortly
disappears, but if the operator tries to activate any of the touch screen controls,
the icon re-appears.
2.
To unlock the display, press the display lock key again. The display lock LED turns
off and an unlocked image briefly appears on the screen.
4-6
Description
Used for
How to Use
Operators Manual
Ventilator Shutdown
Description
Used for
How to Use
Double-tap
Maximizing or minimizing
the viewable area of a
dialog, control, or waveform, expanding or collapsing tooltips
Drag
Touch and
hold
Touch an item
and hold for at
least 0.5 seconds.
N/A
Drag and
drop
4.5
Ventilator Operation
Caution:
Do not set containers filled with liquids on the ventilator, as spilling may
occur.
Operators Manual
4-7
Operation
After turning on the ventilator, it will display a Covidien splash screen, and
run Power On Self Test (POST). After the splash screen appears, the ventilator
gives a choice to ventilate the same patient or a new patient, or run SST.
Ventilation parameters are entered via the graphical user interface
(GUI) using the following general steps:
1.
2.
Turn the knob to the right to increase or to the left to decrease the value.
3.
Touch Accept to apply the setting or Accept ALL to apply several settings at once.
Note:
Quick Start allows for rapid setup and initiation of mechanical ventilation. Review
Quick Start parameters and ensure they are consistent with institutional practice
before using this feature.
WARNING:
Prior to patient ventilation, select the proper tube type and tube ID.
To use Quick Start
1.
Touch New Patient.
4-8
2.
3.
Turn the knob to adjust the patients PBW or gender and height (if gender is
selected, the height selection becomes available).
4.
5.
Connect the circuit wye adapter to the patient's airway or interface connection.
The patient is ventilated with the institutionally configured or factory configured
QUICK START defaults according to the PBW or gender/height entered, and circuit
type used during SST. There is no prompt to review the settings and the waveforms display appears.
Note:
Connecting the circuit wye adapter to the patient's airway or interface connection
prior to making the ventilation settings causes the ventilator to begin ventilation using
Safety Pressure Control Ventilation (Safety PCV) and annunciate a PROCEDURE ERROR
alarm. As soon as the ventilator receives confirmation of its settings (by touching
Accept or Accept ALL), it transitions out of safety PCV, resets the alarm, and
delivers the chosen settings. Reference Safety PCV Settings, p. 10-72 for a listing of
Operators Manual
Ventilator Shutdown
these settings.
To resume ventilating the same patient
1.
Touch Same Patient on the GUI screen. The previous ventilator settings are displayed on the screen for review prior to applying the settings to the patient.
2.
If the settings are acceptable, touch Accept to confirm. To change any settings,
touch the setting, turn the knob clockwise to increase the value of the setting or
counter-clockwise to decrease the value of the setting, and touch Accept to confirm. To make several settings changes at once, make the desired changes, then
touch Accept ALL to confirm. The appearance of the settings changes from white,
non-italic font showing the current setting to yellow italics (noting the pending
setting). After the settings are accepted, the appearance changes back to white
non-italic font.
3.
2.
Operators Manual
Enter the patients PBW or gender and height (if gender is selected, the height
selection becomes available).
4-9
Operation
4.5.1
3.
If the default ventilator settings are appropriate for the patient, touch START to
confirm the settings, otherwise, touch a ventilator setting and turn the knob to
adjust the parameter. Continue this process for all parameters needing adjustment.
4.
5.
Ventilator Settings
WARNING:
The ventilator offers a variety of breath delivery options. Throughout the
patient's treatment, the clinician should carefully select the ventilation mode
and settings to use for that patient based on clinical judgment, the condition
and needs of the patient, and the benefits, limitations and characteristics of
the breath delivery options. As the patient's condition changes over time,
periodically assess the chosen modes and settings to determine whether or
not those are best for the patient's current needs.
The following ventilator settings appear at the new patient setup screen:
4-10
Predicted Body Weight (PBW) Adjust the patients PBW, or select the
patients gender and height. Reference Predicted Body Weight (PBW) Calculation,
p. 4-21.
Operators Manual
Ventilator Shutdown
Note:
VS, PAV+, and TC are only available during INVASIVE ventilation.
Swipe the menu tab on the left side of the GUI and touch Setup.
Figure4-4.Open Menu Tab
Operators Manual
Setup button
4-11
Operation
3.
4.
Continue in this manner until all changes are made, then touch Accept or Accept
ALL.
5.
Touch START. Ventilation does not begin until the breathing circuit is connected
to the patients airway. After ventilation begins, waveforms begin plotting on the
displayed waveforms axes. Reference Waveforms, p. 3-44 for information on
setting up the graphics display.
If changes to any settings are required, return to the Vent Setup screen as
described above, or touch a setting icon in the current settings area. Reference
Areas of the GUI, p. 4-3, item 9.
4-12
Operators Manual
Ventilator Shutdown
Note:
A yellow triangle icon appears on tabs and buttons displayed on the GUI containing
unread or un-viewed items. When the item containing the icon is touched, the icon
disappears.
Note:
To make any settings changes after completing patient setup, touch the Vent tab on
the left side of the Setup dialog and make settings changes as described above. The
current setting appears in white font and changes to yellow italics to note the new
value is pending.Touch Accept or Accept ALL to confirm a single change or a batch of
changes. Once the settings are accepted, their appearance changes to white font.
Note:
Selecting QUICK START, Accept, Accept ALL or Start from the Setup dialog
implements all settings in ALL four Setup tabs (Vent Setup, Apnea, Alarms, and More
Settings) and dismisses the Setup dialog.
Tube Compensation
Tube Compensation is a spontaneous breath type selected during ventilator
setup. It allows the ventilator to deliver additional positive pressure to overcome the resistance imposed by the patients artificial airway.
Reference p. 4-12 for more information on setting up the ventilator. Reference
Ventilator Settings Range and Resolution, p. 11-8 for details of specific tube
compensation settings.
To enable TC
1.
Touch the VENT tab on the GUI screen. Reference New Patient setup Screen, p. 412.
2.
3.
4.
5.
Select the tube type (either endotracheal or tracheostomy) and set the tube ID to
correspond to patient settings.
After making the changes, touch Accept to apply the new settings, or Cancel to
cancel all changes and dismiss the dialog.
Operators Manual
4-13
Operation
WARNING:
To prevent inappropriate ventilation with TC, select the correct Tube Type (ET
or Tracheostomy) and tube inner diameter (ID) for the patients ventilatory
needs. Inappropriate ventilatory support leading to over-or under-ventilation
could result if an ET tube or trach tube setting larger or smaller than the actual
value is entered.
To select new settings for the tube, follow these steps
1.
Touch Vent Setup on the GUI screen to display the Ventilator setup screen.
2.
3.
4.
5.
Touch Accept or Accept ALL to apply the new settings, or Cancel to cancel all
changes and dismiss the dialog.
Note:
The tube type and tube ID indicators flash if TC is a new selection, indicating the
need for entry of the correct tube type and tube ID.
.
To select new settings for the humidifier, follow these steps
1.
From the Ventilator setup screen, touch the More Settings tab. A dialog appears
containing selections for humidifier type and volume.
A Humidifier Volume button appears below the selection only if Non-Heated
Expiratory Tube or Heated Expiratory Tube is selected as the humidifier type.
4-14
2.
Turn the knob to enter a value equal to the dry volume of the humidifier chamber
being used.
3.
Touch Accept or Accept ALL to apply the new settings, or Cancel to cancel all
changes and dismiss the dialog.
Operators Manual
Ventilator Shutdown
4.5.2
Apnea Settings
After making the necessary changes to the ventilator settings touch the Apnea
tab on the left side of the Setup dialog. Although changing the apnea settings
is not required, confirm the default settings are appropriate for the patient.
Apnea ventilation allows pressure control or volume control breath types.
Parameters in pressure-controlled apnea breaths include f, PI, TI O2%, and TA.
Volume controlled apnea breath parameters are f, VT, VMAX, Flow pattern,
O2%, and TA.
Note:
If QUICK START is chosen, the apnea tab on the Vent Setup screen shows a yellow
triangle, indicating the apnea settings have not been reviewed.
Figure4-6.Apnea Setup Screen
Enter the desired apnea settings in the same manner as for the ventilator settings.
3.
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4-15
Operation
During apnea pressure ventilation, apnea rise time % is fixed at 50%, and the
constant parameter during a respiratory rate change is TI.
4.5.3
Alarm Settings
After accepting the apnea settings, the display returns once more to show the
waveforms. Return to the Vent Setup dialog and touch the Alarms tab on the
left side of the GUI screen or touch the alarm icon in the constant access icons
area of the GUI screen. The alarms screen appears with the default alarm settings. Reference Alarms Settings Screen, p. 4-17. Review and adjust the alarm
settings appropriately for the patient.
4-16
Note:
If Quick Start is chosen, the alarms tab on the dialog shows a yellow triangle,
indicating the alarm settings have not been reviewed.
Note:
Reference Alarm Settings Range and Resolution, p. 11-17 for new patient default
alarm values. These defaults cannot be changed. The clinician can adjust alarm
settings by following the procedure below. The alarm settings are retained in memory
when the ventilators power is cycled and same patient is selected.Otherwise, current
settings revert to new patient defaults when a new patient is selected.
Operators Manual
Ventilator Shutdown
2
1
2.
3.
4.
Note:
There is an additional alarm setting for TC, PAV+, VS, and VC+ breath types: High
inspired tidal volume (2VTI). This alarm condition occurs when the inspired tidal
volume is larger than the setting value. A 1VTI alarm will also cause breath delivery to
transition to the exhalation phase to avoid delivery of excessive inspiratory volumes.
WARNING:
Prior to initiating ventilation and whenever ventilator settings are changed,
ensure the alarm settings are appropriate for the patient.
Operators Manual
4-17
Operation
WARNING:
Setting any alarm limits to OFF or extreme high or low values, can cause the
associated alarm not to activate during ventilation, which reduces its efficacy
for monitoring the patient and alerting the clinician to situations that may
require intervention.
4.5.4
Note:
A sample alarm tone sounds for verification at each volume level change. Re-adjust
the alarm volume by moving the alarm volume slider to increase or decrease the alarm
volume.
Note:
Do not block the patient wye while the ventilator is waiting for a patient connection.
Otherwise the blockage could imitate a patient connection.
4-18
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Ventilator Shutdown
4.5.5
Operators Manual
4-19
Operation
Touch and turn the knob for any other settings that need to be changed.
3.
3.
The ventilator settings and the alarm settings chosen remain in memory after
the a power cycle, as long as the same patient is chosen when the ventilator is
set up again. If a new patient is being ventilated, the ventilator and alarm settings revert to their default values. If all power is lost (both AC and battery),
the ventilator and alarm settings in effect prior to the power loss are automatically restored if the power loss duration is five (5)minutes or less. If the power
loss lasts longer than five minutes, ventilation resumes in Safety PCV. Ventilator and alarm settings must be reset for the patient being ventilated. Reference
Safety PCV Settings, p. 10-72 for a list of these settings.
To use the Previous Setup button
1.
To return to the previous settings, touch Previous Setup on the GUI screen. The
ventilator restores the main control and breath settings previously used, as well as
the alarm and apnea settings, and prompts a review by highlighting the previous
values in yellow. The ventilator, alarm, and apnea settings tab text is also shown
in yellow and the tabs show a yellow triangle, indicating there are previous settings that have not been reviewed.
2.
The Previous Setup button disappears when the previous settings are confirmed and re-appears when ventilating with new settings.
4.5.6
4-20
Operators Manual
Ventilator Shutdown
respiratory rate, and the effects on breath timing due to flow pattern, tidal
volume, and VMAX during mandatory PC, VC, BiLevel, or VC+ breaths. With
BiLevel, PC and VC+ breaths, three padlock icons are located underneath
the breath timing graph allowing the operator to select, from left to right, TI,
I:E ratio, or TE as the constant variable during rate changes (or TH, TH:TL ratio,
or TL in BiLevel). If the ventilation mode is SPONT, the padlock icons do not
appear, and the breath timing graph only displays TI for a manual inspiration.
If the mandatory type is VC, the icons do not appear, but the breath timing
graph displays TI, I:E ratio, and TE.
To choose a constant timing variable for rate changes
1.
Touch a padlock icon corresponding to the parameter to make constant during
rate changes (this changes the padlocks appearance from unlocked to locked).
The locked parameter glows in the settings area.
4.6
2.
3.
Touch Accept.
Operators Manual
4-21
Operation
that include the 20- to 23-week gestational-age neonates and the young male
and female adolescent adults at the foot of the ARDS tables, their PBW values
were taken as the 50th percentile numbers in the Fenton tables and the CDC
and NCHS charts and tables, respectively. Note that the Fenton tables provided
the exclusive information for premature and infant data between 20 weeks
and 50 weeks of fetal and gestational growth.123
4.7
Note:
Any repeated values noted in the tables are the result of decimal rounding.
4.7.1
4.7.2
Full-face Mask: Puritan Bennett Benefit Full Face Mask (large, part number
4-005253-00), ResMed Mirage Non-Vented Full Face Mask (medium)
Infant Nasal Prongs: Sherwood Davis & Geck Argyle CPAP Nasal Cannula (small),
Hudson RCI Infant Nasal CPAP System (No. 3)
4-22
Operators Manual
Ventilator Shutdown
4.7.3
WARNING:
Use only non-vented patient interfaces with NIV. Leaks associated with
vented interfaces could result in the ventilators inability to compensate for
those leaks, even if Leak Sync is employed.
WARNING:
Full-face masks used for non-invasive ventilation should provide visibility of
the patient's nose and mouth to reduce the risk of emesis aspiration.
WARNING:
When Using NIV, the patients exhaled tidal volume (VTE) could differ from
the ventilators monitored patient data VTE reading due to leaks around the
interface. To avoid this, ensure Leak Sync is installed.
NIV Setup
NIV can be initiated from either the New Patient Setup screen during Vent
start-up or while the patient is being ventilated invasively. Reference the table
below for using NIV patient setup information.
2.
3.
4.
5.
Select mode.
6.
7.
Operators Manual
2.
3.
4.
4-23
Operation
4.7.4
Some ventilator settings available during INVASIVE ventilation are not available
during NIV. Reference the following table for automatic settings changes
when changing vent type from INVASIVE to NIV.
Table4-3. INVASIVE to NIV on Same Patient
Current INVASIVE setting
Mandatory type:
Neonatal: PC
Adult/Pediatric: VC
Spontaneous type: PS
(not user-settable)
DSENS
Note:
In any delivered spontaneous breath, either INVASIVE or NIV, if Pressure Support is set
to 0 cmH2O, there is always a target inspiratory pressure of 1.5 cmH2O applied.
When in NIV, the Vent Setup buttons appearance changes, letting the operator know the vent type is NIV.
4-24
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Ventilator Shutdown
4.7.5
N/A
Alarm settings:
4PPEAK, 4VE TOT, 4VTE MAND, 4VTE SPONT
DSENS
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4-25
Operation
4.7.6
WARNING:
No audible alarm sounds in conjunction with the visual 2TI SPONT indicator,
nor does the indicator appear in any alarm log or alarm message.
It is possible the target inspiratory pressure may not be reached if the 2TI SPONT
setting is not long enough, or if system leaks are so large as to cause the ventilator to truncate the breath at the maximum allowable2TI SPONT setting.
4-26
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Ventilator Shutdown
4.7.7
Note:
To reduce the potential for not reaching the target pressure, minimize the leaks in the
system and increase the Rise time % and/or decrease the ESENS setting, if appropriate.
4.7.8
Touch the Alarms tab at any time during ventilation to show the current limits
and the monitored patient value shown in white on the indicating arrows for
each alarm. If an alarm is occurring, the indicator LED color changes based on
alarm priority Reference Alarm Prioritization, p. 6-16 for colors and meanings
Operators Manual
4-27
Operation
4.8
Note:
The upper and lower limits of an alarm cannot conflict with each other.
Note:
The upper limits for the spontaneous exhaled tidal volume and mandatory exhaled
tidal volume alarms are always the same value. Changing the upper limit of one alarm
automatically changes the upper limit of the other.
Manual Inspiration
A manual inspiration is an operator-initiated mandatory (OIM) inspiration.
When the operator presses the Manual inspiration key, the ventilator delivers
the currently specified apnea breath setting for spontaneous breaths, or the
currently specified mandatory breath setting for mandatory breaths, either
volume- or pressure-based. A volume-based manual inspiration is compliancecompensated. Pressing the Manual inspiration key while in BiLevel mode will
transition from TH to TL or TL to TH depending on when in the breath cycle the
key was pressed.
4.9
4-28
Touch RM.
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Ventilator Shutdown
3.
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4-29
Operation
4.9.1
4.
5.
Accept or reject the maneuver results. If the result is accepted, its value is saved.
Touch Accept or Reject to save or dismiss results. If Accept is touched, the results
are displayed.
4-30
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Ventilator Shutdown
2.
Touch Accept or Reject to save or dismiss results. If Accept is touched, the results
are displayed.
Operators Manual
4-31
Operation
4.10
4-32
O2 sensor enabled
Neonatal 40% O2
Pediatric/adult 100% O2
Operators Manual
Ventilator Shutdown
Note:
The oxygen sensor has three states: Enabled, Disabled, and Calibrate. The oxygen
sensor is enabled at ventilator startup regardless if New Patient or Same Patient setup
is selected.
To enable, or disable the O2 sensor
1.
2.
Touch the More Settings tab. The more settings screen appears.
Figure4-14.More Settings Screen with O2 Sensor Enabled
4.10.1
3.
Touch the button corresponding to the desired O2 sensor function (Enable or Disable).
4.
Touch Accept.
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4-33
Operation
always produces a voltage. The useful life of the cell can also be shortened by
exposure to elevated temperatures and pressures. During normal use in the
ICU, the oxygen sensor lasts for approximately one year the interval for
routine preventive maintenance.
Because the oxygen sensor constantly reacts with oxygen, it requires periodic
calibration to prevent inaccurate O2% alarm annunciation. Once a calibrated
oxygen sensor and the ventilator reach a steady-state operating temperature,
the monitored O2% will be within three percentage points of the actual value
for at least 24 hours. To ensure the oxygen sensor remains calibrated, recalibrate the oxygen sensor at least once every 24 hours.
Typically, the clinician uses an O2 analyzer in conjunction with the information
given by the ventilator. If a NO O2 SUPPLY alarm occurs, compare the O2 analyzer reading with the ventilators O2 reading for troubleshooting purposes.
The ventilator automatically switches to delivering air, only (21% oxygen).
4.10.2
4.10.3
1.
2.
3.
Touch the Calibrate for the O2 sensor. The oxygen sensor calibrates within two
minutes. Reference More Settings Screen with O2 Sensor Enabled, p. 4-33.
4-34
1.
Connect the ventilators oxygen hose to a known 100% O2 source (for example,
a medical-grade oxygen cylinder).
2.
Operators Manual
Ventilator Shutdown
4.11
3.
Connect the ventilator oxygen hose to another known 100% O2 source (for
example, a second medical-grade oxygen cylinder).
4.
Set O2% to each of the following values, and allow one minute after each for the
monitored value to stabilize: 21%, 40%, 90%
5.
Watch the GUI screen to ensure the value for O2 (delivered O2%) is within 3% of
each setting within one minute of selecting each setting.
4.11.1
4.11.2
Technical Fault
A technical fault occurs if a POST or background test has failed. Reference
Power On Self Test (POST), p. 10-76. Based on the test that failed, the ventilator will either ventilate with current settings, ventilate with modified settings,
or enter the Vent Inop state. A technical fault cannot be cleared by pressing
the alarm reset key. It can only be cleared by correcting the fault that caused
it or if alarm reset criteria have been met.
4.11.3
SST
In addition to characterizing the ventilator breathing circuit, SST performs basic
checks on the ventilator's pneumatic system including the breath delivery
Operators Manual
4-35
Operation
PSOL, the Flow Sensors and the Exhalation Valve. Faults detected during SST
must be corrected before ventilation can be started.
4.11.4
Procedure Error
A procedure error occurs when the ventilator senses a patient connection
before ventilator setup is complete. The ventilator provides ventilatory support
using default Safety Pressure Controlled Ventilation (Safety PCV) settings. Reference Safety PCV Settings, p. 10-72
4.11.5
Ventilation Assurance
During ventilation, the ventilator performs frequent background checks of its
breath delivery sub-system (Reference Safety Net, p. 10-71). In the event that
certain critical components in the pneumatics fail, Ventilation Assurance provides for continued ventilatory support using one of three Backup Ventilation
(BUV) strategies, bypassing the fault to maintain the highest degree of ventilation that can be safely delivered (Reference Background Diagnostic System, p.
10-74 for a full description of the Backup Ventilation strategies).
4.11.6
Note:
Do not confuse BUV with Safety PCV, which occurs when a patient is connected
before ventilator setup is complete, or with Apnea ventilation, which occurs in
response to patient apnea.
4-36
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Ventilator Shutdown
connects. If the condition causing SVO can only be corrected by servicing the
ventilator, the SVO alarm cannot be reset by pressing the alarm reset key.
4.11.7
4.12
Ventilator Shutdown
When the ventilator power switch is turned OFF, the ventilator executes an
orderly shutdown routine, saving patient data before removing power. If the
ventilator detects a patient connected when the power switch is turned OFF, a
high priority alarm is annunciated and a banner on the display requires the
operator to confirm that a power down was requested. Only after the operator
confirms will the ventilator execute the shutdown command.
All logs are retained in the ventilators memory upon ventilator shutdown.
When the logs reach the maximum number of entries, the oldest values are
overwritten with new values. Reference Ventilator Logs, p. 8-2 for information
on ventilator logs.
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Operation
4-38
Operators Manual
5.1
Overview
This chapter describes the features of the Puritan Bennett 980 Series Ventilator designed to provide output to the clinician. This includes language,
methods of displaying and transferring data, types of displayed data, and types
of external device ports. Connectivity to an external patient monitoring system
is also included.
5.2
Language
The language used on the ventilator is configured at the factory.
5.3
Data Display
Displayed data are updated in real-time. The practitioner can display up to 60
seconds of waveform data and pause and capture up to two loops using the
screen capture function. The operator can pause the displays and when the
displays are paused, a cursor appears with the relevant numeric values for the
intersecting points of the cursor and waveform or loop. The scalar waveform
contains a single value, but loops contain both x- and y-axis data. The operator
can move the cursor along the waveform or loop using the knob, and read the
corresponding data. Reference Waveforms, p. 3-44 for details regarding configuring and displaying waveforms.
5.4
Data Transfer
Data from the ventilator can be accessed via USB or RS-232 connectors. The
following data are available for downloading via connection to a remote device
or flash drive:
5-1
5.4.1
Waveform data: RS-232 port, USB port with USB to serial conversion capability
(per Comm port configuration)
Results from DCI commands: RS-232 port, USB port with USB to serial conversion
capability (per Comm port configuration)
Covidien recommends a minimum 128 MB flash drive storage device formatted in the 32-bit file format.
To capture GUI screens
1.
Navigate to the desired screen from which you wish to capture an image (for
example, the waveforms screen). There is no need to pause the waveform before
performing the screen capture.
2.
Touch the screen capture icon in the constant access icons area of the GUI screen.
If desired, navigate to another screen and repeat steps 1 and 2 for up to ten (10)
images. If another image is captured, increasing the queue to eleven images, the
newest image overwrites the oldest image so there are always only ten images
available.
Note:
If the camera icon appears dim, it means that the screen capture function is
currently processing images and is unavailable. When processing is finished, the
camera icon is no longer dim and the screen capture function is available.
To transfer the captured images to a USB storage device
1.
Swipe the Menu on the left side of the GUI. Reference Open Menu Tab, p. 4-11.
5-2
2.
Touch Screen Capture. A list of screen captures appears, identified by time and
date. A slider also appears if more images than shown are present.
3.
Insert a passive USB storage device (flash drive) into one of the USB ports at the
rear of the ventilator. Reference Port Locations, p. 5-18. If more than one USB
storage device is installed in the ventilator, touch the button of the destination
USB device where the image will be copied.
Operators Manual
Data Transfer
5.4.2
4.
5.
Touch Copy. The image is stored on the destination USB storage device.
6.
Alternatively, touch Select All, and all images in the list are stored on the USB
device and which can then be viewed and printed from a personal computer.
Note:
The file format of screen captures is .PNG.
Communication Setup
To specify the communication configuration for the ventilator
1.
Touch the Configure icon in the constant access icons area of the GUI. A menu
appears with several tabs.
2.
Touch Comm Setup tab. The Comm Setup screen appears allowing three (3) ports
that can be configured. These ports can be designated as DCI, Philips, Spacelabs,
or Waveforms.
Note:
Waveforms can be selected on any port, but only on one port at a time.
Operators Manual
5-3
5.4.3
3.
Select the desired baud rate. If waveforms was selected, the baud rate automatically becomes configured to 38400.
4.
5.
Connect the device to the previously configured port. Reference Port Locations, p. 5-18 for a description and the locations of the Comm ports.
5-4
Operators Manual
Data Transfer
Note:
When a USB port is configured as a Comm port, it is necessary to use a USB-to-serial
adapter cable. This adapter must be based on the chipset manufactured by Prolific.
For further information, contact your Covidien representative.
Serial Commands
The ventilator system offers commands that allow communication to and from
the ventilator using a Comm port. Commands to the ventilator from a remote
device include:
5.4.5
Note:
The ventilator responds only if it receives a carriage return <CR> after the command
string.
RSET Command
The RSET command clears data from the ventilator receive buffer. The ventilator does not send a response to the host system. Enter the RSET command
exactly as shown:
Operators Manual
5-5
RSET<CR>
5.4.6
SNDA Command
The SNDA command instructs the ventilator to send information on ventilator
settings and monitored patient data to the host system. Enter the SNDA
command exactly as shown:
SNDA<CR>
When the ventilator receives the command SNDA<CR>, it responds with the
code MISCA, followed by ventilator settings and monitored patient data information.
The MISCA response follows this format:
MISCA
706
97
<STX>
<ETX>
<CR>
Fields not available are marked as Not used. Underscores represent one or
more spaces that pad each character string.
The table below lists MISCA responses to SNDA commands.
Table5-1.MISCA Response
Component
5-6
Description
MISCA
706
97
<STX>
Operators Manual
Data Transfer
Operators Manual
Description
Field 5
Field 6
Field 7
Field 8
Field 9
Field 10
Field 11
Field 12
Field 13
Field 14
Field 15
Field 16
Field 17 - 20
Field 21
Field 22
Field 23
Field 24
Field 25
Field 26
Field 27
Field 28 - 29
Field 30
Field31 - 33
Field 34
Field 35
Field 36
Field 37
5-7
5-8
Description
Field 38
Field 39
Field 40
Field 41
Expiratory component of monitored value of I:E ratio, assuming inspiratory component of 1 (6 characters)
Field 42
Field 43 - 44
Field 45
Field 46
Field 47
Field 48
Field 49 - 50
Field 51
Field 52
Field 53
Field 54
Field 55
Field 56
Field 57
Field 58 - 59
Field 60
Field 61
Field 62
Field 63
Field 64
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Data Transfer
Operators Manual
Description
Field 65
Field 66
Field 67
Field 68
Field 69
Field 70
Field 71
Field 72 - 83
Field 84
Field 85
Field 86
Field 87
Field 88
Field 89
Field 90
Field 91
Field 92
Field 93
Field 94
Field 95
Field 96
Field 97
Field 98
Field 99
5-9
5.4.7
Description
Field 100
Constant during rate setting change for pressure control mandatory breaths
(I-TIME or I/E___ or______) (6 characters) (where ______ represents TE or PCV not
active)
Field 101
<ETX>
<CR>
SNDF Command
SNDF is a command sent from an external host device to the ventilator system
instructing it to transmit all ventilator settings data, monitored patient data,
and alarm settings and occurrences. Enter the SNDF command exactly as
shown:
SNDF<CR>
When the ventilator receives the command SNDF<CR>, it responds with the
code MISCF, followed by ventilator settings, monitored patient data, and
alarm information
The MISCF response follows this format:
MISCF
1225*
169
<STX>
<ETX>
<CR>
5-10
Operators Manual
Data Transfer
Note:
Non-applicable fields will either contain zero or be blank.
Table5-2.MISCF Response
Component
Operators Manual
Description
MISCF
1225*
169
<STX>
Field 5
Field 6
Field 7
Field 8
Field 9
Field 10
Field 11
Field 12
Field 13
Field 14
Field 15
Field 16
Field 17
Field 18
Field 19
Field 20
Field 21
Field 22
Field 23
5-11
5-12
Description
Field 24
Field 25
Field 26
Field 27
Field 28
Field 29
Inspiratory component of Apnea I:E ratio (if apnea mandatory type is PC)
(6 characters)
Field 30
Expiratory component of Apnea I:E ratio (if apnea mandatory type is PC)
(6 characters)
Field 31
Field 32
Field 33
Field 34
Field 35
Field 36
High exhaled minute volume (2VE TOT) alarm setting in L/min or OFF
(6 characters)
Field 37
Low exhaled minute volume (4VE TOT) alarm setting in L/min or OFF (6 characters)
Field 38
High exhaled mandatory tidal volume (2VTE MAND) alarm setting in mL or OFF
(6 characters)
Field 39
Low exhaled mandatory tidal volume (4VTE MAND) alarm setting in mL or OFF
(6 characters)
Field 40
High exhaled spontaneous tidal volume (2VTE SPONT alarm setting in mL or OFF
(6 characters)
Field 41
Low exhaled spontaneous tidal volume (4VTE SPONT) alarm setting in mL or OFF
(6 characters)
Field 42
Field 43
Field 44
Field 45
Operators Manual
Data Transfer
Operators Manual
Description
Field 46
Field 47
Field 48
Inspiratory component of I:E ratio setting or High component of H:L ratio setting
(6 characters)
Field 49
Expiratory component of I:E ratio setting or Low component of H:L ratio setting
(6 characters)
Field 50
Field 51
Field 52
Field 53
Humidification type setting (Non-heated exp tube, Heated exp tube, or HME)
(18 characters)
Field 54
Field 55
Field 56
Field 57
Field 58
Field 59
Field 60
Field 61
Field 62
Field 63
Field 64
Field 65
Field 66
Field 67
Field 68
Field 69
5-13
5-14
Description
Field 70
Field 71
Field 72
Field 73
Field 74
Field 75
Expiratory component of monitored value of I:E ratio, assuming inspiratory component of 1 (6 characters)
Field 76
Field 77
Field 78
Field 79
Field 80
Field 81
Field 82
Field 83
Field 84
Not used
Field 85
Field 86
Field 87
Field 88
Field 89
Field 90
Field 91
Field 92
Field 93
Operators Manual
Data Transfer
Description
Field 94
Field 95
Field 96
Field 97
Field 98
Field 99
Field 100
Field 101
Field 102
Field 103
Field 104
Field 105
Field 106
Field 107
Field 108
Field 109
Field 110
Field 111
Field 112
Field 113
Field 114
Field 115
Field 116
Field 117
Field 118
Operators Manual
5-15
Description
Field 119
Field 120
Field 121
Field 122
Field 123
Reserved
Field 124
Field 125
Field 126
Field 127
Field 128
Field 129
Field 130
Field 131
Field 132
Field 133
Field 134
Field 135
Field 136
Field 137
Field 138
Field 139
Field 140
Field 141
Field 142
Field 143
Field 144
5-16
Operators Manual
Data Transfer
Description
Field 145
Field 146
Field 147
Field 148
Field 149
Field 150
Field 151
Field 152
Field 153
Field 154
Field 155
Field 156
Field 157
%LEAK (6 characters)
Field 158
LEAK (6 characters)
Field 159
VLEAK (6 characters)
Field 160
Reserved
<ETX>
<CR>
5.5
Communication Ports
WARNING:
To avoid possible injury, only connect devices that comply with IEC 60601-1
standard to any of the ports at the rear of the ventilator, with the exception
of passive memory storage devices (flash drives) and serial-to-USB adapter
cables. If a serial-to-USB adapter cable is used, it must be connected to an IEC
60601-1-compliant device.
Operators Manual
5-17
WARNING:
To avoid possible injury, do not connect a device that is attached to the
patient to any of the non-clinical ports listed below when the ventilator is
ventilating a patient.
Figure5-2.Port Locations
5-18
Operators Manual
Data Transfer
5.5.1
Port Use
Reference Data Transfer, p. 5-1 for data transfer details.
RS-232 Port
To use the RS-232 port
1.
Obtain a cable with a male DB-9 connector to connect to the RS-232 port on the
ventilator.
2.
3.
Ensure to specify the baud rate, parity, and data bits in the ventilator communication setup to correctly match the parameters of the monitoring device.
4.
A monitor designed to use this port is required for obtaining data from the ventilator. Set up the monitoring device to receive ventilator data. These data can
include waveform data.
5.
Operators Manual
5-19
USB Ports
The USB ports are used for screen captures, or receiving serial data when a USB
port has been configured as a serial port. This is also known as transferring
data via a serial-over-USB protocol. Reference Communication Setup, p. 5-3
for Comm setup configuration. Screen captures require an external USB
memory storage device (flash drive) for screen captures. Instructions for
using this port for screen captures are given. Reference To capture GUI screens,
p. 5-2.
HDMI Port
An external display can be used via connection with the HDMI port.
To use the HDMI port with an external display
1.
Connect one end of an HDMI cable to the HDMI port at the back of the ventilator
(item 6, above).
2.
Connect the other end of the cable to the external display. An HDMI to DVI
adapter may be used.
3.
Turn the device on. The appearance of the GUI now displays on the external
display device.
Service Port
The Service port is used by service personnel only.
5.6
5.7
Display Configurability
The operator can configure some ventilator parameters according to personal
preference. Reference Ventilator Configuration, p. 3-35 for a table showing
which parameters are configurable and by whom.
5-20
Operators Manual
Data Transfer
Reference Preparing the Ventilator for Use, p. 3-37 for information on configuring each display item.
5.8
5.9
Note:
Not all patient monitors are compatible with the Puritan Bennett 980 Series
Ventilator.
Operators Manual
5-21
5-22
Operators Manual
6 Performance
6.1
Overview
This chapter contains detailed information about Puritan Bennett 980 Series
Ventilator performance including:
6.2
Ventilator settings
System Options
Various software options are available for the ventilator. Details for each of
these options are described in the appendices included in this manual.
6.3
6.4
Environmental Considerations
WARNING:
Use of the ventilator in altitudes higher or barometric pressures lower than
those specified could compromise ventilator operation. Reference
Environmental Specifications, p. 11-7 for a complete list of environmental
specifications.
Ventilator Settings
Default ventilator settings are based on the circuit type selected during SST. A
neonatal, pediatric or adult patient circuit can be used, and all accessories
needed to ventilate the patient should be attached when SST is performed.
6-1
Performance
6.4.1
Ventilation Type
The clinician enters the vent type, specifying how the patient will be ventilated;
invasively or non-invasively (NIV). The vent type optimizes the alarm limits for
NIV patients, and disables some settings for NIV ventilation.
6.4.2
Mode
Available ventilation modes are mandatory (A/C) or spontaneous (SPONT)
modes, as well as two mixed modes: SIMV and BiLevel.
BiLevel BiLevel is also a mixed mode which overlays the patients spontaneous breaths onto the breath structure for PC mandatory breaths. Two levels of
pressure, PL and PH are employed. The breath cycle interval for both SIMV and
BiLevel modes is 60/f where f is the respiratory rate set by the operator.
CPAP CPAP is available only when circuit type is neonatal and vent type is NIV.
Breath Type
Mandatory breath types for A/C and SIMV modes include volume controlled
(VC), pressure controlled (PC), or volume control plus (VC+) breath types, also
called Mandatory Type.
6-2
Operators Manual
Ventilator Settings
Flow Trigger (V-TRIG) Changes in flow in the circuit cause the ventilator to
deliver a breath. The breath delivery and exhalation valve flow sensors measure
gas flow in the ventilator breathing system. As the patient inspires, the delivered
flow remains constant and the exhalation valve flow sensor measures decreased
flow. When the difference between the two flow measurements is at least the
operator-set value for flow sensitivity (VSENS), the ventilator delivers a breath.
Operator Trigger (OIM) The operator presses the Manual inspiration key.
An operator initiated mandatory breath is also called an OIM breath. During an
OIM breath, the breath delivered is based on the current settings for a mandatory
breath.
Spontaneous breathing modes such as SIMV, BiLevel, and SPONT include the
following breath types (called Spontaneous Types):
PS (Pressure Support) The ventilator delivers an operator-set positive pressure above PEEP (or PL in BiLevel) during a spontaneous breath. If SIMV is selected
as the mode, PS is automatically selected for spontaneous type.
VS (Volume Support) The ventilator delivers an operator-set positive pressure above PEEP during a spontaneous breath and automatically adjusts the pressure level from breath to breath to consistently deliver the set tidal volume.
Operators Manual
6-3
Performance
IE Sync Trigger When this software option is installed and the IE Sync trigger
type is selected, triggering and cycling of spontaneous breaths occur based on the
patients intra-pleural pressure.
Operator Trigger (OIM) Since the operator can only initiate a mandatory
breath by pressing the Manual inspiration key, spontaneous mode allows OIMs,
but the breath delivered is based on the current apnea breath settings.
Reference Inspiration Detection and initiation, p. 10-4 for details on the different trigger methods.
6.5
Alarms
This manual uses the following conventions when discussing alarms:
A description or name of an alarm without specifying the alarm setting is
denoted with an upward or downward pointing arrow (1 or 3) preceding the
specific alarm name. An alarm setting is denoted as an upward or downward
pointing arrow with an additional horizontal limit symbol (2 or 4) preceding the
specific alarm. Some alarm conditions actually limit breath delivery such as
1PPEAK and 1VTI by truncating inspiration and transitioning to the exhalation
phase. These alarm conditions are denoted as alarm limits. Reference Alarm
Descriptions and Symbols, p. 6-6.
6.5.1
Alarm Messages
Alarms are visually annunciated using an indicator on the top of the GUI, which
has a 360 field of view. If an alarm occurs, this indicator flashes at a frequency
and color matching the alarm priority. The alarms also appear as colored
banners on the right side of the GUI screen. If an alarm occurs, this indicator
appears in the color matching the alarm priority (yellow for low (!) and medium
(!!) priority; red for high (!!!) priority. For technical alarm and non-technical
alarm details, reference the respective tables on p. 6-18 and p. 6-29.
An alarm is defined as a primary alarm if it is the initial alarm. A dependent
alarm arises as a result of conditions that led to the primary alarm. This is also
referred to as an augmentation. An augmentation strategy is built into the ventilator software to handle occurrences where the initial cause of the alarm has
the potential to precipitate one or more additional alarms. When an alarm
occurs, any subsequent alarm related to the cause of this initial alarm aug-
6-4
Operators Manual
Ventilator Settings
ments the initial alarm instead of appearing on the GUI as a new alarm. The
initial alarms displayed analysis message is updated with the related alarms
information, and the Alarm Log Event column shows the initial alarm as Augmented.
A primary alarm consists of a base message, analysis message, and a
remedy message. The base message describes the primary alarm. The analysis message describes the likely cause of the alarm and may include alarm augmentations. The remedy message provides information on what to do to
correct the alarm condition.
Alarm banners, when dragged leftward from the right side of the GUI, display
messages for the indicated active alarms. The figure below, shows the alarm
message format.
Figure6-1.Alarm Message Format
Base message
Analysis message
Remedy message
A latched alarm is one whose visual alarm indicator remains illuminated even
if the alarm condition has autoreset. Latched alarm indicators are located on
the sides of the omni-directional LED. A latched alarm can be manually reset
by pressing the alarm reset key. If no alarms are active, the highest priority
Operators Manual
6-5
Performance
Note:
When a new lockable alarm occurs, the alarm will not start to sound audibly if the
previous lockable alarm was silenced.
The system adds dependent alarms to the analysis messages of each active
primary alarm with which they are associated. If a dependent alarm resets, the
system removes it from the analysis message of the primary alarm.
The priority level of a primary alarm is equal to or greater than the priority level of
any of its active dependent alarms.
If a primary alarm resets, any active dependent alarms become primary unless they
are also dependent alarms of another active primary alarm. This is due to different
reset criteria for primary and dependent alarms.
The system applies the new alarm limit to alarm calculations from the moment a
change to an alarm limit is accepted.
The priority level of a dependent alarm is based solely on its detection conditions
(not the priority of any associated alarms.
When an alarm causes the ventilator to enter OSC or safety valve open (SVO), the
patient data display (including waveforms) is blanked. The elapsed time without
ventilatory support (that is, since OSC or SVO began) appears on the GUI screen.
If the alarm causing OSC or SVO is autoreset, the ventilator resets all patient data
alarm detection algorithms.
6-6
Symbol
1PCOMP
1O2%
Operators Manual
Ventilator Settings
1VE TOT
2VE TOT
1VTE
2VTE
2VTI
1PVENT
1fTOT
2fTOT
1TI SPONT
2TI SPONT
1PPEAK
2PPEAK
3PPEAK
4PPEAK
3VTE MAND
4VTE MAND
3VE TOT
4VE TOT
3VTE SPONT
4VTE SPONT
Operators Manual
Symbol
3O2%
6-7
Performance
6.5.2
6.5.3
6.5.4
6-8
Operators Manual
Ventilator Settings
6.5.5
WARNING:
The audio alarm volume level is adjustable. The operator should set the
volume at a level that allows the operator to distinguish the audio alarm
above background noise levels. Reference To adjust alarm volume, p. 3-41.
Alarm Testing
Testing the alarms requires oxygen and air sources and stable AC power. Test
the alarms at least every six months, using the procedures described.
Required Equipment
If the alarm does not annunciate as indicated, verify the ventilator settings and
repeat the test. The alarm tests check the operation of the following alarms:
CIRCUIT DISCONNECT
SEVERE OCCLUSION
AC POWER LOSS
APNEA
NO O2 SUPPLY
Disconnect the patient circuit from the ventilator and turn the ventilator off for at
least five minutes.
2.
Operators Manual
6-9
Performance
3.
4.
5.
30 L/min
TPL: 0 s
Flow pattern: SQUARE
VSENS:
3 L/min
O2%: 21%
PEEP: 5 cmH2O
6.
7.
6-10
Operators Manual
Ventilator Settings
8.
Set the graphics display to a volume-time plot (for use in the APNEA alarm test).
9.
Connect an Adult patient circuit to the ventilator and attach a test lung to the
patient wye.
Note:
To ensure proper test results, do not touch the test lung or patient circuit during the
CIRCUIT DISCONNECT alarm test.
CIRCUIT DISCONNECT alarm test
1.
Allow the ventilator to deliver at least four breaths. During the inspiratory phase
of a breath, disconnect the inspiratory filter from the To Patient port. The ventilator annunciates a CIRCUIT DISCONNECT alarm after the inspiratory filter is disconnected.
2.
Connect the inspiratory filter to the To Patient port to autoreset the alarm.
30 L/min
2PPEAK: 20 cmH2O
2.
After one breath, the ventilator annunciates a HIGH CIRCUIT PRESSURE (1PPEAK)
alarm. If the alarm does not sound, check the patient circuit for leaks.
Operators Manual
6-11
Performance
2.
3.
4.
Disconnect the ventilator breathing circuit from the FROM PATIENT port and block
the gas flow.
5.
While maintaining the occlusion, ensure the safety valve open indicator appears
on the status display, the GUI shows the elapsed time without normal ventilation
support, and the test lung inflates and deflates rapidly with small pulses as the
ventilator delivers trial pressure-based breaths.
6.
Connect the power cord to AC facility power. The AC POWER LOSS or LOW
BATTERY alarm autoresets.
Note:
To avoid triggering a breath during the apnea interval, do not touch the test lung
or patient circuit.
Note:
For the apnea alarm test, the exhaled tidal volume (VTE) displayed in the patient
data area must be greater than half the delivered volume shown on the volumetime plot in the graphics display in order for apnea to autoreset. Reference Apnea
Ventilation, p. 10-41 for a technical description of apnea ventilation.
2.
6-12
Operators Manual
Ventilator Settings
3.
Squeeze the test lung twice to simulate two subsequent patient-initiated breaths.
The APNEA alarm autoresets.
4.
3.
Slowly squeeze the test lung to simulate spontaneous breaths. The ventilator
annunciates a LOW EXHALED SPONTANEOUS TIDAL VOLUME (3VTE SPONT) alarm
at the start of the fourth consecutive spontaneous inspiration.
4.
5.
Press the alarm reset key to reset the 4VTE SPONT alarm.
2.
Connect the oxygen inlet supply. The NO O2 SUPPLY alarm autoresets within two
breaths after oxygen is reconnected.
2.
3.
Operators Manual
Attach the ventilators oxygen gas hose to a known air supply (for example, a
medical grade air cylinder) or a wall air outlet.
6-13
Performance
6.5.6
4.
attach the ventilators air gas hose to a known medical oxygen supply.
5.
Observe the GUI screen. The delivered O2% display should decrease, and the ventilator should annunciate a medium priority 3O2% alarm within 60 s and a high
priority 3O2% alarm within two (2) minutes.
6.
7.
Observe the GUI screen. The delivered O2% display should increase, and the ventilator should annunciate a a medium priority 1O2% alarm within 60 s and a high
priority 1O2% alarm within two (2) minutes.
8.
Remove the air gas hose from the oxygen supply and reconnect the hose to a
known medical air supply.
9.
Remove the oxygen gas hose from the air supply and reconnect the hose to a
known oxygen supply.
10.
WARNING:
Before returning the ventilator to service, review all settings and set
appropriately for the patient to be ventilated.
Viewing Alarms
When an alarm occurs, the omni-directional LED at the top of the GUI flashes
in a color corresponding to the alarm priority, an audible series of tones
sounds, and an alarm banner displays on the GUI. Reference Areas of the GUI,
p. 4-3. When the alarm banner appears, it displays its base message. Touching
the individual alarm causes an expanded explanation to appear, containing
analysis and remedy messages, and may contain a link to the alarm log or the
alarms settings screen. Touch the link to display requested information. The
omni-directional LED remains steadily lit and may appear multicolored,
meaning that multiple alarms with varying priority levels have occurred. During
an event that causes multiple alarms, the ventilator simultaneously displays the
two highest priority active alarms.
6-14
Operators Manual
Ventilator Settings
6.5.7
Alarm Delay
Determination of an Alarm Condition
The delay time from the moment the alarm condition first occurs until the
alarm is annunciated is imperceptible.
Delay to/from a Distributed Alarm System
For alarm conditions relayed via the serial port, the overall delay is dependent
upon the polling rate of the external device. The delay from the time the serial
port is polled by the external device, until the alarm message leaves the serial
port does not exceed 3 seconds. An example of an external device is a patient
monitor.
6.5.8
Alarm Handling
Current alarm settings are saved in the ventilators non-volatile memory
(NVRAM). If the alarm settings are changed by another clinician, those settings become applicable. For example, there are no operator-selectable default
alarm settings.
The ventilator systems alarm handling strategy is intended to
Detect and call attention to legitimate causes for caregiver concern as quickly as
possible, while minimizing nuisance alarms.
Identify the potential cause and suggest corrective action for certain types of
alarms. However, the clinician must make the final decision regarding any clinical
action.
Ventilator alarms are categorized as high priority, medium priority, or low priority, and are classified as technical or non-technical.
The ventilator is equipped with two alarms the primary alarm and secondary
alarm. The primary alarm annunciates high, medium, and low priority alarms
when they occur. The secondary alarm (also named immediate priority in the
table below) is a continuous tone alarm and annunciates during Vent Inop conditions or complete loss of power. This alarm is powered by a capacitor and
lasts for at least 120 seconds.
Operators Manual
6-15
Performance
The table below lists alarm priority levels and their visual, audible, and autoreset characteristics. An alarm autoresets when the condition causing the alarm
no longer exists.
Table6-2.Alarm Prioritization
6-16
Priority Level
Visual indicator
Audible indicator
Autoreset
characteristics
Immediate
Continuous tone
alarm sounding for at
least 120 s.
N/A
High-priority audible
alarm (a sequence of
five tones that repeats
twice, pauses, then
repeats again).
Medium: Prompt
attention necessary.
Medium-priority
audible alarm (a
repeating sequence of
three tones).
Steadily illuminated
yellow omni-directional LED located on the
top of the GUI, yellow
alarm banner on GUI
screen, and yellow bar
next to alarm setting
icon on Alarms screen.
Low-priority audible
alarm (two tone, nonrepeating).
Operators Manual
Ventilator Settings
Visual indicator
Audible indicator
Autoreset
characteristics
Steadily illuminated
green omni-directional
LED located on the top
of the GUI, no alarm
banner, and white
values next to alarm
setting icon on Alarms
screen.
None.
None
Immediate
None
Name
Priority
System Response
Vent-Inop
High
Exh BUV
High
Backup ventilation
Insp BUV
High
Backup ventilation
Mix BUV
High
Backup ventilation
High
SVO
Caution
High
Warning
Medium
Notification
Low
Reference the table below for a list of ventilator technical alarms, their meaning, and what to do if they occur.
Operators Manual
6-17
Performance
Reference Alarm Settings Range and Resolution, p. 11-17 for the settings,
ranges, resolutions, new patient default values, and accuracies of all the ventilator alarms.
Table6-4. Technical Alarms
Alarm message
Meaning
What to do
O2 SENSOR
Re-calibrate or replace O2
sensor.
DEVICE ALERT
A non-technical alarm is an alarm caused due to a fault in the patient-ventilator interaction or a fault in the electrical or gas supplies that the practitioner
may be able to alleviate.
6-18
Base message
Priority
AC POWER LOSS
Low
Analysis
message
Operating on
vent main battery.
Remedy
message
N/A
Comments
Ventilators power
switch is ON. Ventilator automatically
switches to battery
power. AC power
not available.
Battery operating
indicator on status
display turns on.
Resets when AC
power is restored.
Operators Manual
Ventilator Settings
CIRCUIT
DISCONNECT
COMPLIANCE
LIMITED VT
(alarm is not
adjustable)
(patient data
alarm)
Operators Manual
Priority
Analysis
message
Medium
High
Extended apnea
duration or multiple apnea
events.
High
Remedy
message
Comments
No ventilation
Check patient
Reconnect circuit.
Ventilator has
recovered from
unintended power
loss lasting more
than five minutes,
detects circuit disconnect. The GUI
screen displays
elapsed time
without ventilator
support. Resets
when patient is
reconnected.
High
No ventilation
Check patient.
Reconnect circuit.
Ventilator detects
circuit disconnect;
the GUI screen displays elapsed time
without ventilator
support. Resets
when patient is
reconnected.
Low
Compliance
compensation
limit reached
Compliance volume
required to compensate delivery of
a VC, VC+ or VS
breath exceeds the
maximum allowed
for 3 of the last 4
breaths.
6-19
Performance
1PCOMP (patient
data alarm)
Priority
Analysis
message
Low
Medium
Last 3 breaths
set limit.
High
Last 4 or more
breaths set
limit.
Low
Last spont
breath set
PPEAK limit - 5
cmH2O.
Medium
High
Last 3 spont
breaths set
PPEAK limit - 5
cmH2O.
Last 4 or more
spont breaths
set PPEAK limit- 5
cmH2O.
Remedy
message
Comments
Check patient,
circuit & ET tube.
Measured airway
pressure set limit.
Ventilator truncates current breath
unless already in
exhalation. Possible
dependent alarms:
3VTE MAND,
3 VE TOT, 1fTOT. Corrective action:
Check patient.
Check tube type/ID
setting. Consider
reducing % Supp
setting or increasing 2PPEAK.
In TC:
Check for
leaks, tube
type/ID setting.
6-20
Operators Manual
Ventilator Settings
Priority
Analysis
message
Low
Last 2 breaths,
pressure set
limit.
Medium
Last 4 breaths,
pressure set
limit
High
Last10 or more
breaths, pressure set limit
Remedy
message
Check for leaks.
Comments
Peak inspiratory
pressure alarm
setting. (Available
only when Mandatory Type is VC+* or
when Vent Type is
NIV. Target pressure = the low limit:
PEEP + 3 cmH2O.
Ventilator cannot
deliver target
volume. Possible
dependent alarms:
1fTOT.
Corrective action:
Check patient and
settings; check for
leaks.
* Because the VC+ pressure control algorithm does not allow the target inspiratory pressure to fall
below PEEP + 3 cmH2O, attempting to set the 4PPEAK alarm limit at or below this level will turn the
alarm off.
1O2% (patient
data alarm)
Operators Manual
Medium
Measured O2%
> set for 30 s
but < 2 min
High
Measured O2%
> set for 2
min.
6-21
Performance
Priority
Analysis
message
Remedy
message
Comments
3O2% (patient
data alarm)
High
Measured O2%
< set O2%.
1VTE (patient
data alarm
Low
Last 2 breaths
set limit.
Medium
Last 4 breath s
set limit.
Check settings,
changes in
patient's R&C.
High
Last 10 or more
breaths set
limit.
Exhaled tidal
volume set limit.
Alarm updated
whenever exhaled
tidal volume is
recalculated. Possible dependent
alarm: 1VE TOT
Low
Medium
High
Expiratory minute
volume set limit.
Alarm updated
whenever an
exhaled minute
volume is recalculated. Possible
dependent alarm:
1VTE.
Low
Medium
High
Total respiratory
rate set limit.
Alarm updated at
the beginning of
each inspiration.
Reset when measured respiratory
rate falls below the
alarm limit. Possible
dependent alarms:
3VTE MAND,
3VTE SPONT, 3VE TOT.
1fTOT (patient
data alarm)
6-22
Operators Manual
Ventilator Settings
Priority
Analysis
message
Low
1 breath limit.
Medium
2 breaths limit.
High
INOPERATIVE
BATTERY
Operators Manual
Low
Remedy
message
Check patient,
circuit & ET tube.
3 or more
breaths limit.
Inadequate
charge or nonfunctional ventilators primary
battery.
Service/replace
ventilators primary
battery.
Comments
Inspiratory pressure
> 100 cmH2O and
mandatory type is
VC or spontaneous
type is TC or PAV+.
Ventilator truncates current breath
unless already in
exhalation. Possible
dependent alarms:
3VTE MAND,
3VE TOT, 1fTOT.
Corrective action:
1.
Check patient
for agitation.
Agitated
breathing,
combined with
high % Supp
setting in PAV+
can cause
over-assistance. Consider reducing %
Supp setting.
2.
6-23
Performance
PAV STARTUP
TOO LONG
(patient data
alarm) (occurs
only if PAV+ is in
use)
6-24
Priority
Analysis
message
Low
Last 2 spont
breaths = PBW
based TI limit.
Medium
Last 4 spont
breaths = PBW
based TI limit.
High
Last 10 or more
spont breaths =
PBW based TI
limit.
Low
Medium
High
Remedy
message
Comments
Check patient.
Check for leaks.
Unable to assess
patients resistance
and compliance
during PAV startup.
Possible dependent
alarms 3VTE SPONT,
3VE TOT, 1fTOT. Corrective action:
Check patient.
(Patients inspiratory times may be too
short to evaluate
resistance and compliance.) Check that
selected humidification type and empty
humidifier volume
are correct.
Operators Manual
Ventilator Settings
Priority
Analysis
message
Remedy
message
Comments
Low
R and/or C over
15 minutes old.
Medium
R and/or C over
30 minutes old.
Unable to assess
resistance and/or
compliance during
PAV+ steady-state.
Startup was successful, but later
assessments were
unsuccessful. Corrective action:
Check patient.
(Patients inspiratory times may be too
short to evaluate
resistance and compliance.) Check that
selected humidification type and empty
humidifier volume
are correct.
LOSS OF POWER
Immediate
N/A
N/A
The ventilator
power switch is ON
and there is insufficient power from
AC and the battery.
There may not be a
visual indicator for
this alarm, but an
independent audio
alarm sounds for at
least 120 seconds.
Alarm annunciation can be reset by
turning power
switch to OFF position.
Operating on
battery.Ventilator battery operational time <
10 minutes.
Replace or allow
ventilator battery
to recharge.
Resets when
battery has ten
minutes of operational time remaining or when AC
power is restored.
LOW BATTERY
Operators Manual
Medium
6-25
Performance
Priority
Analysis
message
LOW BATTERY
High
Operating on
battery. Ventilator battery operational time < 5
minutes
Replace or allow
ventilator battery
to recharge
Resets when
battery has five
minutes of operational time remaining or when AC
power is restored.
3VTE MAND
(patient data
alarm)
Low
Last 2 mand
breaths set
limit.
Medium
Last 4 mand
breaths set
limit.
Exhaled mandatory
tidal volume set
limit. Alarm
updated whenever
exhaled mandatory
tidal volume is
recalculated. Possible dependent
alarms: 3VE TOT,
1fTOT.
3VTE SPONT
(patient data
alarm)
High
Last 10 or more
mand breaths
set limit.
Low
Last 4 spont
breaths set
limit
Medium
Last 7 spont
breaths set
limit
High
6-26
Last 10 or more
spont breaths
set limit
Remedy
message
Comments
Operators Manual
Ventilator Settings
Priority
Low
Last spont
breath set
limit.
In TC, VS, or
PAV+:
Medium
Last 3 spont
breaths set
limit.
High
Operators Manual
Analysis
message
Remedy
message
Check patient
and settings.
Last 4 or more
spont breaths
set limit.
Low
Medium
High
Comments
Delivered inspiratory volume inspiratory limit. Ventilator
transitions to exhalation. Possible
dependent alarms:
3VTE SPONT,3VE TOT,
1fTOT
Corrective action:
Check for leaks.
Check for the
correct tube type.
Check the VTI or VTI
setting. In PAV+,
check for patient
agitation, which
can cause miscalculation of RPAV and
CPAV. Consider
reducing % Supp
setting. Check 2VTI.
Total minute
volume set limit.
Alarm updated
whenever exhaled
minute volume is
recalculated. Possible dependent
alarms3VTE MAND,
3VTE SPONT, 1fTOT
6-27
Performance
Priority
Analysis
message
Remedy
message
Comments
Low
Medium
Last 10 or more
spont (or mand)
breaths, pressure > max
allowable level.
SPONT,
1fTOT
3VE TOT,
Corrective action:
Check patient and
settings.
NO AIR SUPPLY
High
NO O2 SUPPLY
Low
Check O2 source.
Operator-set O2%
equals 21%. Resets
if O2 supply connected
High
Ventilator delivers
21% O2 instead of
set O2%. Resets if
oxygen supply connected.
High
Provide alternate
ventilation. Complete setup process.
Ventilator begins
safety ventilation.
Resets when ventilator startup procedure is complete.
PROCEDURE
ERROR
6-28
Operators Manual
Ventilator Settings
Priority
Analysis
message
SEVERE
OCCLUSION
High
Little/no ventilation.
Check patient.
Provide alternate
ventilation. Clear
occlusions; drain
circuit.
Ventilator enters
occlusion status
cycling (OSC).
Patient data displays are blanked
and GUI screen displays elapsed time
without ventilator
support.
Low
Check proximal
flow sensor connections and tubes
for occlusions or
leaks
Ventilator
switched OFF
with patient
connected to
breathing circuit.
Return power
switch to ON position and disconnect patient before
turning power off.
INADVERTENT
POWER OFF
High
Remedy
message
Comments
Meaning
Response
AC POWER LOSS
Operators Manual
6-29
Performance
Meaning
Response
CIRCUIT DISCONNECT
* Because the VC+ pressure control algorithm does not allow the target inspiratory pressure to fall
below PEEP + 3 cmH2O, attempting to set the 4PPEAK alarm setting at or below this level will turn the
alarm off.
1O2% (patient data alarm)
6-30
Operators Manual
Ventilator Settings
Meaning
The O2% measured during any
phase of a breath cycle is 7%
(12% during the first hour of
operation) or more below the
O2% parameter for at least 30
seconds. The percentage
window increases by 5% for
four minutes after increasing
the set O2% value.
Response
Use an external O2
monitor and disable the O2
sensor.
Re-run SST.
INOPERATIVE BATTERY
Operators Manual
The battery charge is inadequate after 6 hours of attempted charge time or the battery
system is non-functional.
6-31
Performance
LOSS OF POWER
Meaning
The PBW-based inspiratory time
for the last two spontaneous
breath exceeds the ventilatorset limit. Active only when Vent
Type is INVASIVE.
Response
6-32
Operators Manual
Ventilator Settings
NO AIR SUPPLY
NO O2 SUPPLY
1PCOMP
Meaning
The minute volume for all
breaths is alarm setting.
Response
In TC:
In PAV+:
PROCEDURE ERROR
Operators Manual
Complete ventilator
startup procedure.
6-33
Performance
Meaning
The patient circuit is severely
occluded. The ventilator enters
occlusion status cycling. The
elapsed time without ventilatory support appears.
Response
Insp target pressure > (PPEAK PEEP - 3 cmH2O), when spontaneous type is VS or when mandatory type is VC+.
PROX INOPERATIVE
6-34
Operators Manual
Ventilator Settings
6.5.9
6.5.10
Apnea Alarm
The APNEA alarm indicates neither the ventilator nor the patient has triggered
a breath for the operator-selected apnea interval (TA). TA is measured from the
start of an inspiration to the start of the next inspiration and is based on the
ventilators inspiratory detection criteria. TA can only be set via the apnea ventilation settings.
The APNEA alarm autoresets after the patient initiates two successive breaths,
and is intended to establish the patient's inspiratory drive is reliable enough to
resume normal ventilation. To ensure the breaths are patient-initiated (and not
due to autotriggering), exhaled volumes must be at least half the inspired VT
(this avoids returning to normal ventilation if there is a disconnect).
6.5.11
Operators Manual
6-35
Performance
6.5.12
Note:
6.5.13
6.5.14
6-36
Operators Manual
Ventilator Settings
The 1PPEAK alarm truncates inspiration and transitions the ventilator into the
exhalation phase and the limit cannot be set less than
PEEP + 7 cmH2O, or
PEEP + PI + 2 cmH2O, or
Operators Manual
6-37
Performance
O2 SUPPLY alarm. The ventilator checks the 1O2% alarm limit against the measured oxygen percentage at one-second intervals.
6.5.16
6.5.17
6.5.18
6-38
Operators Manual
Ventilator Settings
6.5.19
6.5.20
6.5.21
Operators Manual
6-39
Performance
The 3PPEAK alarm is active for mandatory and spontaneous breaths, and is
present only when Vent Type is NIV or Mandatory Type is VC+. During VC+,
the 3PPEAK alarm can be turned OFF. The 3PPEAK alarm can always be turned
OFF during NIV. The 4PPEAK alarm limit cannot be set to a value greater than
or equal to the 2PPEAK alarm limit.
WARNING:
Because the VC+ pressure control algorithm does not allow the target
inspiratory pressure to fall below PEEP + 3 cmH2O, attempting to set the
4PPEAK alarm limit at or below this level will turn the alarm off.
6-40
Operators Manual
Ventilator Settings
oxygen sensor is shown in the patient data area. Reference Vital Patient Data,
p. 3-42 to include O2% if it is not displayed.
6.5.23
6.5.24
6.5.25
Operators Manual
6-41
Performance
The 3VE TOT alarm can detect a leak or obstruction in the patient circuit, a
change in compliance or resistance, or a change in the patient's breathing pattern. The 3VE TOT alarm can also detect too-small tidal volumes, which could
lead to hypoventilation and hypoxia (oxygen desaturation).
The ventilator phases in changes to the 3VE TOT alarm limit immediately to
ensure prompt notification of prolonged low tidal volumes.
6.5.26
6.5.27
6.6
6-42
Operators Manual
Ventilator Settings
Reference Vital Patient Data, p. 3-42 to change the displayed patient data
parameters or the order in which they are displayed.
If any patient data values are displayed continuously blinking, it means their
values are shown clipped to what has been defined as their absolute limits. If
the values are displayed in parentheses ( ), it means they are clipped to their
variable limits.Variable limits are calculated values derived from the set PBW
and ventilator settings. Displayed patient data values that have been clipped
should be viewed as suspect.
Dashes (--) are displayed if the patient data value is not applicable based on
mode/breath type combinations.
Note:
If no value is displayed, then the ventilator is in a state where the value cannot be
measured.
6.6.1
Note:
All displayed patient volume data represent lung volumes expressed under BTPS
conditions.
6.6.2
6.6.3
Operators Manual
6-43
Performance
6.6.4
6.6.5
6.6.6
6.6.7
6.6.8
6.6.9
6-44
Operators Manual
Ventilator Settings
6.6.10
6.6.11
6.6.12
I:E Ratio
The ratio of inspiratory time to expiratory time for the previous breath, regardless of breath type. Updated at the beginning of the next inspiration. When I:E
ratio is 1:1, it is displayed as XX:1. Otherwise it is displayed as 1:XX.
6.6.13
Note:
Due to limitations in setting the I:E ratio in PC ventilation, the monitored data display
may not exactly match the I:E ratio setting.
6.6.14
6.6.15
Operators Manual
6-45
Performance
6.6.16
6.6.17
6.6.18
6.6.19
6.6.20
6.6.21
6.6.22
6-46
Operators Manual
Ventilator Settings
6.6.24
6.6.25
6.6.26
6.6.27
6.6.28
Operators Manual
6-47
Performance
V pt
C STAT = ------------------------------ C ckt
P ckt PEEP
C STAT
Static compliance
P ckt
The pressure in the patient circuit measured at the end of the 100 ms interval
defining the pause-mechanics plateau
V pt
PEEP
C ckt
RSTAT is calculated using this equation after CSTAT is computed and assuming
a VC breath type with a SQUARE waveform:
R STAT
6-48
Static resistance
C STAT
Static compliance
Operators Manual
Ventilator Settings
R STAT
C ckt
V pt
C ckt
1 + -------------- P PEAK P PL
C STAT
= -------------------------------------------------------------------V pt
P PL
P PEAK
During the pause, the most recently selected graphics are displayed and
frozen, to determine when inspiratory pressure stabilizes. CSTAT and RSTAT are
displayed at the start of the next inspiration following the inspiratory pause
and take this format:
CSTAT xxx
or
RSTAT yyy
Special formatting is applied if the software determines variables in the equations or the resulting CSTAT or RSTAT values are out of bounds:
6.6.30
Parentheses ( ) signify questionable CSTAT or RSTAT values, derived from questionable variables.
RSTAT ------ means resistance could not be computed, because the breath was not
of a mandatory, VC type with square flow waveform.
Operators Manual
6-49
Performance
6.6.31
6.6.32
C20/C
C20/C is the ratio of compliance of the last 20% of inspiration to the compliance of the entire inspiration.
6.6.33
6.6.34
6.6.35
Displayed O2%
The percentage of oxygen in the gas delivered to the patient, measured at the
ventilators outlet, upstream of the inspiratory filter. It is intended to provide a
check against the set O2% for alarm determination, and not as a measurement
of oxygen delivered to the patient. O2% data can be displayed as long as the
O2 monitor is enabled. If the monitor is disabled, dashes (--) are displayed. If a
device alert occurs related to the O2 monitor, a blinking 0 is displayed.
6-50
Operators Manual
7 Preventive Maintenance
7.1
Overview
This chapter contains information on maintenance of the Puritan Bennett
980 Series Ventilator. It includes
7.2
How to clean, disinfect, or sterilize the ventilator and its main components
7.3
7-1
Preventive Maintenance
Maintenance
Replace bowl if it is
cracked.
7-2
Frequency
Operators Manual
Condensate vial
Frequency
Maintenance
Operators Manual
7-3
Preventive Maintenance
Frequency
Maintenance
Battery
Battery
Replace
7.4
Replace. Run flow sensor calibration, exhalation valve calibration, EST and SST after
replacing the exhalation valve
flow sensor assembly.
Caution:
Use specified cleaning, disinfecting, and sterilization agents and procedures
for the appropriate part as instructed.
7-4
2.
Wipe the GUI, BDU, and ventilator base, removing any dirt or foreign substances.
3.
4.
If necessary, vacuum any cooling vents on the GUI and BDU with an electrostatic
discharge (ESD)-safe vacuum to remove any dust.
Operators Manual
Procedure
Comments/Cautions
Operators Manual
7-5
Preventive Maintenance
Procedure
Vacuum the vents at the back
of the GUI and BDU to remove
dust.
Comments/Cautions
N/A
1. Chemicals stated are the generic equivalents of Mr. Muscle Window & Glass
7.5
Risks associated with reuse of single-patient use items include but are not
limited to microbial cross-contamination, leaks, loss of part integrity, and
increased pressure drop. When cleaning reusable components, do not use
hard brushes or implements that could damage surfaces.
Table7-3.Component Cleaning Agents and Disinfection Procedures
Part
Exhalation valve flow sensor
assembly
Cleaning Agent/Procedure
Comments/Cautions
Sporox II (Sultan)
.
Reusable patient circuit tubing
7-6
Operators Manual
Cleaning Agent/Procedure
Comments/Cautions
Discard
N/A
Battery
Expiratory filter
Operators Manual
Metrizyme (Metrex
Research Corporation)
ENZOL (ASP)
7-7
Preventive Maintenance
Cleaning Agent/Procedure
Reference Condensate Vial
Cleaning, p. 7-8 for cleaning
instructions.
Other accessories
Comments/Cautions
Clean condensate vial
Metrizyme (Metrex
Research Corporation)
ENZOL (ASP)
N/A
To clean parts
1.
Wash parts in warm water using a mild soap solution.
2.
Thoroughly rinse parts in clean, warm water (tap water is acceptable) and wipe
dry.
3.
Clean or disinfect ventilator surfaces and component parts per the procedures
listed for each component. Reference Surface Cleaning Agents, p. 7-5. Reference
Component Cleaning Agents and Disinfection Procedures, p. 7-6 for acceptable
cleaning and disinfecting agents.
4.
5.
Visually inspect the components for cracks or other damage prior to use.
Dispose of damaged parts according to the institutions policy.
Note:
The o-ring (1) should remain in place during cleaning.
To clean the condensate vial
1.
Un-cap (2) the drain port from the condensate vial, but do not detach the retainer
(3).
7-8
Operators Manual
2.
Rinse the condensate vial in water to remove any accumulations prior to cleaning.
3.
Wipe the condensate vial assembly with the suggested cleaning solution to
remove any accumulated material. The vial assembly may be fully immersed in the
cleaning solution. Reference Component Cleaning Agents and Disinfection Procedures, p. 7-6 for the proper condensate vial cleaning solution.
4.
Rinse the vial assembly with clean water. The assembly may be fully immersed to
rinse.
5.
7.5.2
O-ring
Drain cap
Retainer
Operators Manual
7-9
Caution:
Do not immerse the expiratory filter in liquid cleaning agent. Use care to
prevent the cleaning agent from making contact with the filter media inside
the filter housing.
Note:
Follow the institutions protocol for handling, storage, and disposal of potentially
biocontaminated waste.
To clean the expiratory filter
1.
Spray or wipe down surfaces of the exterior housing and housing bottom with
cleaning solution. Reference Component Cleaning Agents and Disinfection Procedures, p. 7-6, for appropriate cleaning solutions. Use care to prevent the solution
from contacting the filter media via the filter outlet, or entering the filter intake
opening or from patient port.
7-10
Operators Manual
External housing
Housing bottom
2.
Operators Manual
Wipe the interior surface of the from patient port with the solution to clean it.
7-11
Preventive Maintenance
3.
Allow to dry by orienting the filter in the upright position for the contact time
period recommended by the solutions manufacturer.
7-12
Operators Manual
7.5.3
4.
Rinse all filter surfaces that were exposed to the cleaning solution with water,
using care to prevent liquid from entering the filter.
5.
Allow the filter housing to dry until all liquid has evaporated.
The exhalation valve flow sensor assembly contains the exhalation valve body,
exhalation valve flow sensor, exhalation valve diaphragm, expiratory filter seal,
and pressure sensor filter. The expiratory flow sensor electronics consist of the
hot film wire and the thermistor. Since it is protected by the expiratory filter, it
does not require or need replacement or disinfection on a regular basis. It is,
however, removable and may be disinfected. Expected service life is 25 disinfection cycles.
Caution:
To avoid damage to the expiratory flow sensor element
Do not touch the hot film wire or thermistor in the center port
Do not vigorously agitate fluid through the center port while immersed.
Do not forcefully blow compressed air or any fluid into the center cavity.
Operators Manual
7-13
Preventive Maintenance
7-14
WARNING:
Damaging the flow sensors hot film wire or thermistor in the center port can
cause the ventilators spirometry system to malfunction.
Operators Manual
Top view
Bottom view
Electrical contacts
Filter grommet
Removal
To remove the exhalation valve flow sensor assembly
1.
Lift up on the expiratory filter latch and open the expiratory filter door.
2.
Operators Manual
With thumb inserted into the plastic exhalation port and four (4) fingers under the
exhalation valve flow sensor assembly, pull it down until it snaps out. To avoid
7-15
Preventive Maintenance
damaging the flow sensor element, do not insert fingers into the center
port.
Figure7-7.Exhalation Valve Flow Sensor Assembly Removal
7-16
Operators Manual
2.
Dispose of removed items according to the institutions protocol. Follow local governing ordinances regarding disposal of potentially bio-contaminated waste.
Disinfection
WARNING:
Do not steam autoclave the exhalation valve flow sensor assembly or sterilize
with ethylene oxide gas. Either process could cause the ventilators
spirometry system to malfunction when reinstalled in the ventilator.
Operators Manual
7-17
Preventive Maintenance
WARNING:
Use only the disinfectants described. Reference Component Cleaning Agents
and Disinfection Procedures, p. 7-6. Using disinfectants not recommended by
Covidien may damage the plastic enclosure or electronic sensor components,
resulting in malfunction of the ventilators spirometry system.
WARNING:
Follow disinfectant manufacturers recommendations for personal protection
(such as gloves, fume hood, etc.) to avoid potential injury.
1.
Pre-soak exhalation valve flow sensor assembly in the enzymatic solution.Reference Operator Preventive Maintenance Frequency, p. 7-2. The purpose for this
pre-soak is to break down any bio-film that may be present. Follow manufacturers instructions regarding duration of soak process.
7-18
Caution:
Do not use any type of brush to scrub the exhalation valve flow sensor
assembly, as damage to the flow sensing element could occur.
2.
3.
4.
Immerse the in the disinfectant solution, oriented as shown, and rotate to remove
trapped air bubbles in the its cavities. Keep immersed for the minimum time
period by the manufacturer or as noted in the institutions protocol.
Operators Manual
Figure7-11.Immersion Method
5.
At the end of the disinfecting immersion period, remove and drain all disinfectant.
Ensure all cavities are completely drained.
Rinsing
1.
Rinse the exhalation valve flow sensor assembly using clean, de-ionized water in
the same manner used for the disinfection step.
2.
Drain and repeat rinsing three times with clean, de-ionized water.
WARNING:
Rinse according to manufacturers instructions. Avoid skin contact with
disinfecting agents to prevent possible injury.
3.
Operators Manual
After rinsing in de-ionized water, immerse in a clean isopropyl alcohol bath for
approximately 15 seconds. Slowly agitate and rotate to empty air pockets.
7-19
Preventive Maintenance
Drying
1.
Dry in a low temperature warm air cabinet designed for this purpose. Covidien
recommends a convective drying oven for this process, with temperature not
exceeding 60C (140F).
Caution:
Exercise care in placement and handling in a dryer to prevent damage to
the assemblys flow sensor element.
Inspection
Reference Exhalation Valve Flow Sensor Components, p. 7-15 while inspecting
the exhalation valve flow sensor assembly.
7-20
1.
Inspect the plastic body, diaphragm sealing surface, filter grommet and the seal
groove on the bottom side for any visible damage, degradation, or contamination.
2.
Inspect electrical contacts for contaminating film or material. Wipe clean with a
soft cloth if necessary.
3.
Inspect the hot film wire and thermistor in the center port for damage and for contamination.DO NOT ATTEMPT TO CLEAN EITHER OF THESE. If contamination
exists, rinse again with de-ionized water. If rinsing is unsuccessful or hot film wire
or thermistor is damaged, replace the exhalation valve flow sensor assembly.
Operators Manual
7.5.4
Diaphragm
1.
After drying the exhalation valve flow sensor assembly, remove the pressure
sensor filter from the reprocessing kit and install its large diameter into the filter
grommet with a twisting motion until flush with the plastic valve body, as shown.
The narrow end faces out.
Figure7-13.Installing the Pressure Sensor Filter
2.
Remove the expiratory filter seal from the kit and turn the assembly so its bottom
is facing up.
3.
Install the seal into the recess with the flat side facing outward, away from the
recess. Reference Installing the Expiratory Filter Seal, p. 7-22.
Operators Manual
7-21
Preventive Maintenance
1
4.
7-22
Remove the diaphragm from the kit and install it. The outer seal bead rests in the
outer groove.
Operators Manual
1
5.
7.5.5
Replace the exhalation valve flow sensor assembly any time if cracked or damaged
in use, or if a malfunction occurs during SST or EST.
2.
Replace the assembly if damage is noted to the hot film wire and thermistor in the
center port.
3.
To install the exhalation valve flow sensor assembly into the ventilator
1.
With the expiratory filter door open, insert the assembly directly under the exhalation valve and push straight up until it snaps into place. Reference Installing the
Exhalation Valve Flow Sensor Assembly, p. 7-24. To avoid damaging the hot film
wire, do not insert fingers into any opening.
2.
Install the expiratory filter by sliding it onto the tracks in the door, and orienting
the filters From Patient port through the hole in the door.
3.
Operators Manual
7-23
Preventive Maintenance
4.
7.5.6
7.6
Storage
1.
Pre-test the exhalation valve flow sensor assembly before storage by installing it
into the ventilator and running SST to test the integrity of the breathing system.
Reference To run SST, p. 3-48
2.
After performing SST, remove the assembly and place it into a protective bag or
similar covered container.
Component Sterilization
To sterilize parts
1.
Sterilize per the components instructions-for use or the steam sterilization procedure described. Reference Sterilization Parameters, p. 7-25 and Component Sterilization Procedures on page 7-25.
7-24
2.
After the components are sterilized, visually inspect them for cracks or other
damage.
3.
Operators Manual
Table7-4.Sterilization Parameters
Autoclave sterilization
Effective sterilization occurs by pre-vac sterilization of wrapped goods (132C for 4 minutes). Refer to
pre-vac system manufacturers program parameters or follow the steam sterilizer manufacturers
instructions.
1.
2.
3.
Wrap each component in a legally marketed sterilization wrap that has been cleared by FDA for
use in pre-vac sterilization using the parameters described above.
4.
5.
6.
7.
8.
Run SST.
Procedure
Operators Manual
Comments/Cautions
7-25
Preventive Maintenance
Procedure
Clean and autoclave the reusable tubing; clean the clamp.
Reference Surface Cleaning
Agents, p. 7-5 for approved
cleaning agents.
Comments/Cautions
N/A
7.8
Safety Checks
Covidien factory-trained service personnel should perform Extended Self Test
(EST) on the ventilator after servicing it at the intervals specified in the table
above. Reference the Puritan Bennett 980 Series Ventilator Service Manual
for details on performing EST.
7.9
7.10
Documentation
Covidien factory-trained service personnel should manually enter the service
date, time, and nature of repair/preventive maintenance performed into the
log using a keyboard on the GUI.
7-26
Operators Manual
7.11
2.
3.
4.
Select Add Entry, and using the buttons to the right of each line, complete the
entry.
5.
Recharge batteries prior to patient ventilation. If batteries are older than three (3)
years, use new batteries.
3.
Operators Manual
7-27
Preventive Maintenance
7-28
Operators Manual
8 Troubleshooting
8.1
Overview
This chapter contains information regarding ventilator logs on the Puritan Bennett 980 Series Ventilator.
8.2
WARNING:
To avoid a potential electrical shock, do not attempt to correct any electrical
problem with the ventilator while it is connected to AC power.
Problem Categories
For the Puritan Bennett 980 Series Ventilator Operators Manual, troubleshooting is limited to responding to ventilator alarms and reviewing various
ventilator logs. For detailed alarm information, including how to respond to
alarms, Reference Chapter 6 to address individual alarms that may occur
during ventilator use. Qualified service personnel who have attended the Covidien training class for Puritan Bennett 980 Series Ventilators should consult the
Puritan Bennett 980 Series Ventilator Service Manual for detailed repair
information and ventilator diagnostic codes.
8.3
8.4
8-1
Troubleshooting
8.5
Ventilator Logs
The ventilator uses various logs to store event information for later retrieval
when managing a patients treatment. Some of the logs are accessible during
ventilation and some logs are only available to Covidien personnel when the
ventilator is in Service mode. The Puritan Bennett 980 Series Ventilator
Service Manual gives more details regarding logs available to qualified service
personnel.
When New Patient is selected during ventilator setup, patient data, ventilator
settings, and alarm logs are cleared, but this information is available for Service
personnel review following New Patient selection when the ventilator is set up.
8-2
Alarms Log The alarm log records up to 1000 alarms that have occurred,
whether they have been reset or autoreset, the priority level, and their analysis
messages. The alarm log is accessible during normal ventilation and in Service
mode. A date- and time-stamped entry is made in the log whenever an alarm is
detected, escalated, reset or auto-reset. An entry is also made when an alarm
silence interval begins, ends, or is canceled. If one or more alarms have occurred
since the last time the alarm log was viewed, a triangular icon appears on the GUI
indicating there are unread items. The alarm log is stored in non-volatile memory
(NVRAM) and may be re-displayed after the ventilators power is cycled.If the ventilator enters BUV for any reason, this is also entered into the alarm log. The alarm
log is cleared by setting the ventilator up for a new patient.
Settings Log The settings log records changes to ventilator settings for retrospective analysis of ventilator-patient management. The time and date, old and
new settings. and alarm resets are recorded. A maximum of 500 settings changes
can be stored in the log. The settings log is cleared when the ventilator is set up
for a new patient. The settings log is accessible in normal ventilation mode and
Service mode.
Patient Data Log This log records every minute (up to 4320 patient data
entries) consisting of date and time of the entry, patient data name, and the
patient data value during ventilator operation. It is cleared when the ventilator is
set up for a new patient. Three tabs are contained in the patient data log:
Vital Patient data The log contains the same information that the clinician
has configured in the patient data banner at the top of the GUI. If the patient
data parameters in the banner are changed, these changes are reflected the
next time the patient data log is viewed.
Additional Patient Data 1 This log corresponds to the patient data parameters set on page 1 of the additional patient data banner. A total of 15 parameters are stored here, consisting of date and time of the entry (recorded every
minute), patient data name, and the patient data value during ventilator operation.
Operators Manual
Ventilator Logs
Additional Patient Data 2 This log corresponds to the patient data parameters set on page 2of the additional patient data banner. A total of ten (10)
parameters are stored here, consisting of date and time of the entry (recorded
every minute), patient data name, and the patient data value during ventilator
operation.
System Diagnostic Log The System Diagnostic Log contains the date and
time when an event occurred, the type of event, the diagnostic code(s) associated with the event and any notes.Reference the Puritan Bennett 980
Series Ventilator Service Manual (10078090) for specific information contained in the System Diagnostic Log. The diagnostic log is not cleared when
the ventilator is set up for a new patient.
System Communication Log This log contains diagnostic information generated by the ventilators communication software. Reference the Puritan
Bennett 980 Series Ventilator Service Manual (10078090) for specific information contained in the System Communication Log.
EST/SST Diagnostic Log The EST/SST diagnostic log displays the time, date,
test/event, system code (reference the Puritan Bennett 980 Series Ventilator
Service Manual), type, and notes.
EST/SST status log The EST and SST status log displays the time, date, test,
test status (passed or failed).
General Event log The general event log contains ventilator-related information not found in any other logs. It includes changes in alarm volume, when the
ventilator entered and exited Stand-By, GUI key presses, respiratory mechanics
maneuvers, O2 calibration, patient connection, elevate O2, and warning notifications. The General event log can display up to 256 entries and is not cleared upon
new patient setup.
Service Log The service log is accessible during normal ventilation and Service
modes and contains the nature and type of the service, reference numbers specific
to the service event (for example, sensor and actuator ID numbers), manual and
automatic serial number input, and the time and date when the service event
occurred. It is not cleared upon new patient setup.
Operators Manual
8-3
Troubleshooting
3.
Ventilator logs can be saved by entering Service mode, and downloading them
via the ethernet port. Reference the Puritan Bennett 980 Series Ventilator
Service Manual for instructions on downloading ventilator logs.
8.6
Diagnostic Codes
Refer to the diagnostic log for the codes generated during patient ventilation.
For a more information on the diagnostic codes, reference the Puritan Bennett 980 Series Ventilator Service Manual or contact Covidien Technical Support.
8-4
Operators Manual
9 Accessories
9.1
Overview
This chapter includes accessories that can be used with the Puritan Bennett
980 Series Ventilator. Reference Covidien Accessories and Options, p. 9-4 for
part numbers of any items available through Covidien.
The following commonly available accessories from the listed manufacturers
can be used with the ventilator system:
WARNING:
The Puritan Bennett 980 Series Ventilator contains phthalates. When used
as indicated, very limited exposure to trace amounts of phthalates may occur.
There is no clear clinical evidence that this degree of exposure increases
clinical risk. However, in order to minimize risk of phthalate exposure in
children and nursing or pregnant women, this product should only be used as
directed.
9-1
Accessories
9.2
9-2
Operators Manual
Operators Manual
9-3
Accessories
Figure9-2.Additional Accessories
Reference Ventilator with Accessories, p. 9-3 and the figure above for the parts
listed in the following table.
Note:
Occasionally, part numbers change. If in doubt about a part number, contact your
local Covidien representative.
Table9-1.Covidien Accessories and Options
Item
number
9-4
Part number
Test lung
10005490
4-048493-00
4-048491-00
4-048492-00
10063033
10043551
10097468
10086051
Operators Manual
Operators Manual
Part number
10087151
10087159
10087155
10087157
10087152
10087154
10081056
10087156
10087160
10087153
4-074696-00
9-5
Accessories
Part number
4-074712-00
4-074709-00
4-074706-00
10001777
4-074703-00
4-074707-00
4-006541-00
Air hose assembly; Germany, Luxembourg, Austria, Netherlands, Belgium, Croatia, Turkey, Russia, Slovenia, Serbia, Bulgaria, Romania
4-074714-00
4-074713-00
4-074697-00
4-074710-00
4-074705-00
10001766
4-074705-00
4-074708-00
4-001474-00
4-074715-00
Oxygen hose assembly; United Kingdom, Ireland, Switzerland, Hungary, Slovakia, Czech
4-074698-00
For countries not identified, contact your local Covidien representative for the proper
air and oxygen hose part numbers.
9-6
10
10086050
11
4-032006-00
12
10086042
Operators Manual
Part number
13
Humidifier bracket
10086049
14
10087137
4-074600-00
351U5856
16
10063031
17
4-074613-00
G-061235-00
G-061237-00
G-061223-00
6-003030-00
3078447
780-06
RT235
19
10085527
20
4-076900-00
21
10047078
10086048
15
18
Not shown
Hardware options
Not shown
--
4-018506-00
10084331
Software options
Operators Manual
Not shown
10086418
Not shown
10096528
Not shown
IE Sync Software
10086354
Not shown
10096529
9-7
Accessories
Part number
Not shown
10086743
Not shown
10096526
Not shown
PAV+ Software
10086283
Not shown
10096530
Not shown
10086682
Not shown
10096527
1. Reusable filtration system does not include condensate vial. Reusable condensate vial must be ordered separately.
9-8
Operators Manual
10 Theory of Operations
10.1
Overview
This chapter provides specific details on breath delivery functions of the Puritan
Bennett 980 Series Ventilator. The chapter is organized as shown below.
Section Number
Title
Page
10.1
Overview
p. 10-1
10.2
Theoretical Principles
p. 10-3
10.3
Applicable Technology
p. 10-3
10.4
p. 10-4
10.5
p. 10-9
10.6
p. 10-13
10.7
p. 10-17
10.8
p. 10-22
10.9
A/C Mode
p. 10-31
10.10
SIMV Mode
p. 10-34
10.11
p. 10-39
10.12
Apnea Ventilation
p. 10-41
10.13
p. 10-45
10.14
Respiratory Mechanics
p. 10-49
10.15
Ventilator Settings
p. 10-57
10.16
Safety Net
p. 10-71
10.17
p. 10-76
10.18
p. 10-77
10.19
p. 10-77
10-1
Theory of Operations
WARNING:
The ventilator offers a variety of breath delivery options. Throughout the
patient's treatment, the clinician should carefully select the ventilation mode
and settings to use for that patient based on clinical judgment, the condition
and needs of the patient, and the benefits, limitations and characteristics of
the breath delivery options. As the patient's condition changes over time,
periodically assess the chosen modes and settings to determine whether or
not those are best for the patient's current needs.
The gas supplies to which the ventilator are connected must be capable of
delivering 200 L/min flow with the supply pressure between 35 psig and 87
psig (241.8 kPa to 599.8 kPa). These supplies may be compressed air from an
external source (wall or bottled) air or oxygen.
Air and oxygen hoses connect directly to fittings at the rear of the breath delivery unit (BDU). The flow of each gas is metered by a Proportional Solenoid
(PSOL) valve to achieve the desired mix in the Mix Module. The flow through
each PSOL is monitored by separate flow sensors to ensure the accuracy of the
mix. The mixed gases then flow to the Inspiratory Module.
The blended gas in the Inspiratory Module is metered by the Breath Delivery
PSOL and monitored by the Breath Delivery Flow Sensor to ensure that the gas
is delivered to the patient according to the settings specified by the operator.
Delivered tidal volumes are corrected to standard respiratory conditions (BTPS)
to ensure consistent interpretation by the clinician. The Inspiratory Module also
incorporates the Safety Valve, which opens to vent excess pressure and allows
the patient to breathe room air (if able to do so) in the event of a serous malfunction.
Breathing gas exits the Inspiratory Module, passes through an internal bacteria
filter leaving the ventilator via the To Patient port. The ventilator breathing circuit, including the external bacteria filter and humidification means, carries the
breathing gas to the patient.
Exhaled gas leaves the expiratory limb of the breathing circuit through the
From Patient port. The gas is conducted through a condensate vial, the expiratory bacteria filter and the exhalation valve assembly (EVQ) which includes a
pressure sensing port, a flow sensor, and the exhaust port. The gas then flows
through the exhalation valve, which actively controls PEEP while minimizing
pressure overshoot and relieving excess pressures.
Pressure transducers in the inspiratory pneumatic system (PI) and exhalation
compartment (PE) monitor pressures for accurately controlling breath delivery.
10-2
Operators Manual
10.2
Theoretical Principles
This theory of operations is described mainly from a clinical standpoint, discussing how the ventilator responds to various patient inputs, but also including a
general description of the ventilators components and how they work together to manage breath delivery.
10.3
Applicable Technology
The ventilators control is provided by Breath Delivery (BD) and Graphical User
Interface (GUI) Central Processing Units (CPUs). The BD CPU manages all
breath delivery functions and provides background checks on the subsystems
required for breath delivery. The GUI CPU controls the primary display, operator input devices, and the alarm system. The status display, a small, non-interactive LCD display located on the Breath Delivery Unit (BDU) is controlled by its
own processor. Reference Status Display, p. 2-28 for more information.
USB, Ethernet, and HDMI interfaces are provided on the ventilator. The USB
interface supports items such as transferring data to an external monitor via a
serial -over-USB protocol and saving screen captures to a memory storage
device or flash drive. Reference To configure Comm ports, p. 5-4 for information on serial-over-USB data transfer. The Ethernet interface is used by qualified service personnel for accessing ventilator logs and performing software
options installation, and the HDMI interface provides the ability to display the
GUI screen on an external video display device.
Pressure and flow sensors in the inspiratory and expiratory modules to manage
breath delivery processes. Sensor signals are used as feedback to the breath
delivery PSOL and exhalation valve controllers. Additional flow and pressure
sensors are used in the mix module to control the breathing gas composition.
In addition, gas temperature is measured for temperature compensation of
flow readings. Atmospheric pressure is measured in the inspiratory module
and used for BTPS compensation. The sensor signals are filtered using antialiasing filters and sampled with A/D converters. Additional low-pass filters
precondition the signals, the signals are then used for controls and display purposes.
Closed-loop control is used to maintain consistent pressure and flow waveforms in the face of changing patient/system conditions. This is accomplished
by using the output as a feedback signal that is compared to the operator-set
input. The difference between the two is used to drive the system toward the
Operators Manual
10-3
Theory of Operations
Input
Error
signal
Controller
(software)
Actuator
(hardware)
Manipulated
Controlled
Plant
Variable
Variable
Feedback Signal
10.4
+
Note:
In the diagram
above, the plant is the patient and the connected breathing circuit.
10-4
Time-triggered
Operator-initiated
IE Sync triggered (if the IE Sync option is installed) (in SPONT mode, only)
Operators Manual
Note:
Reference Appendix C in this manual for more information on IE Sync.
If the ventilator detects a drop in pressure at the circuit wye or when there is a
decrease in base flow measured at the exhalation valve, the patient is said to
trigger the breath. Mandatory breaths triggered by the patient are referred to
as PIM or patient-initiated mandatory breaths.
All spontaneous breaths are patient-initiated, and are also triggered by a
decrease in circuit pressure or measured base flow indicating the patient is initiating an inspiration.
Another term, autotriggering, is used to describe a condition where the ventilator triggers a breath in the absence of the patients breathing effort. Autotriggering can be caused by inappropriate ventilator sensitivity settings, water
in the patient circuit, or gas leaks in the patient circuit.
10.4.1
Pressure Triggering
If pressure triggering (P-TRIG) is selected, the ventilator transitions into inspiration when the pressure at the patient circuit wye drops below positive end
expiratory pressure (PEEP) minus the operator-set sensitivity level (PSENS). Reference the figure below. As the patient begins the inspiratory effort and
breathes gas from the circuit (event 5, the A-B interval in the figure, below),
pressure decreases below PEEP. When the pressure drops below PEEP minus
PSENS (event 6), the ventilator delivers a PIM breath. The pressure-decline time
interval between events A and B determines how aggressive the patients
inspiratory effort is. A short time interval signifies an aggressive breathing
effort. The A-B interval is also affected by PSENS. A smaller PSENS setting means
a shorter A-B time interval. (The minimum PSENS setting is limited by autotriggering, and the triggering criteria include filtering algorithms that minimize the
probability of autotriggering.)
Operators Manual
10-5
Theory of Operations
10.4.2
Exhalation
Inspiration
A-B interval
Flow Triggering
If flow triggering (V-TRIG) is selected the BDU provides a constant gas flow
through the ventilator breathing circuit (called base flow) during exhalation.
The base flow is 1.5 L/m greater than the value selected for flow sensitivity
(VSENS). Reference Inspiration Using Flow Sensitivity, p. 10-7 where the top
graphic represents expiratory flow and the bottom graphic represents inspiratory flow.]
The ventilators breath delivery flow sensor measures the base flow delivered
to the circuit and the exhalation valve flow sensor measures the flow entering
the exhalation valve. The ventilator monitors patient flow by measuring the difference between the inspiratory and exhaled flow measurements. If the
patient is not inspiring, any difference in measured flows is due to leaks in the
breathing system or flow sensor inaccuracy. The clinician can compensate for
leaks in the breathing system by increasing VSENSto a value equal to desired
VSENS + leak flow.
10-6
Operators Manual
As the patient begins the inspiratory effort and inspires from the base flow, less
exhaled flow is measured, while the delivered flow remains constant. Reference the figure below (event A). As the patient continues to inspire, the difference between the delivery and exhalation valve flow sensor measurements
increases. The ventilator initiates an inspiration when the difference between
the two flow measurements is greater than or equal to the operator-set flow
sensitivity value. Reference Inspiration Using Flow Sensitivity, p. 10-7, (event B).
As with pressure triggering, the time delay between onset of the patients
effort and actual gas delivery depends on
How quickly the exhaled flow declines (that is, the aggressiveness of the inspiratory effort). The more aggressive the inspiratory effort, the shorter the interval,
and
the flow sensitivity value. The smaller the value, the shorter the delay
1.5 L/min
Operators Manual
10-7
Theory of Operations
10.4.3
Time Triggers
The ventilator measures the time interval for each breath and breath phase. If
the ventilator is in Assist/Control (A/C) mode (where the ventilator delivers
breaths based on the breath rate setting), a VIM or ventilator initiated mandatory breath is delivered after the appropriate time interval. The duration of the
breath in seconds (Tb) is 60/f.
Figure10-3.Breath Activity During Time-triggered Inspiration
10.4.4
Operator-initiated Triggers
If the operator presses the Manual inspiration key, an OIM (operator-initiated
mandatory) breath is delivered. The ventilator will not deliver an OIM under the
following conditions:
IE Sync Trigger
IE Sync is a software option that allows the ventilator to trigger a breath based
on a model of the movement of the patients respiratory system. Reference
Appendix C in this manual for a detailed description of the IE Sync option.
10-8
Operators Manual
10.5
10.5.1
IE Sync cycled (in SPONT mode only, if the IE Sync option is installed)
Note:
The allowable incremental value above the target pressure is 1.5 cmH2O once a
portion of inspiration time (Tn) has elapsed. Before Tn, the incremental value is higher
to allow for transient pressure overshoots. For the first 200 ms of inspiration, the
incremental pressure is 10% of the target pressure, up or 8 cmH2O, whichever is
greater. From 200 ms to Tn, the incremental pressure decreases in a linear fashion
from the initial value to 1.5 cmH2O.
Operators Manual
10-9
Theory of Operations
10.5.2
Pressure target
200 ms
Tn
Start breath
10-10
Operators Manual
10.5.3
Inspiration
Trigger
VMAX x ESENS/100
Note:
PAV+ uses a flow-based cycling method, also called ESENS, but it is expressed in L/min
rather than in % of VMAX.
Time-cycling Method
In pressure ventilation, the set inspiratory time (TI) defines the duration of the
inspiratory phase. In volume ventilation, TI depends on the tidal volume (VT)
setting, peak flow (VMAX), flow pattern, and plateau time (TPL). The ventilator
cycles into exhalation when the set TI (pressure ventilation) or computed TI
(volume ventilation) lapses.
10.5.4
IE Sync Cycling
IE Sync detects the end of inspiration when a real-time estimate of the timederivative of intra-pleural pressure,
threshold.
Operators Manual
10-11
Theory of Operations
10.5.5
Backup Methods
There are four backup methods for preventing excessive duration or pressure
during inspiration
10.5.6
Time limit
Time Limit
For adult and pediatric patients, the time limit method ends inspiration and
begins exhalation when the duration of a spontaneous inspiration is greater
than or equal to [1.99 s + 0.02 x PBW (kg)] s.
10.5.7
10.5.8
10.5.9
10-12
Note:
The ventilator does not generate subatmospheric airway pressures during exhalation.
Operators Manual
10.6
10.6.1
Flow (y-axis)
Actual VMAX
Set VT
Set VMAX
TI
Operators Manual
10-13
Theory of Operations
Flow (y-axis)
Set VT
Actual VMAX
TI
Set VMAX
Minimum VMAX
10-14
Operators Manual
C pt ckt
Factor = --------------C pt
Factor
C pt ckt
C pt
V C = C pt ckt P wye P
VC
C pt ckt
Compliance volume
P wye
Operators Manual
10-15
Theory of Operations
10-16
PBW (kg)
Factor
PBW (kg)
Factor
10
10
15
4.6
11
3.5
30
3.4
12.5
2.9
60
2.75
15
2.7
150
2.5
30
2.5
Note:
Compliance compensation calculations are also in effect during exhalation to ensure
spirometry accuracy.
Operators Manual
If the patients compliance decreases beyond the limits of compliance compensation, the ventilator relies on the 2PPEAK alarm setting to truncate the breath
and switch to exhalation.
10.6.2
10.7
I:E ratio
Operators Manual
10-17
Theory of Operations
Rise time %
10-18
Pressure (cmH2O)
Inspiration phase
Flow (L/min)
Expiration phase
Volume (mL)
Constant flow
Operators Manual
10.7.2
Pressure (cmH2O)
Inspiration phase
Flow (L/min)
Expiration phase
Volume (mL)
Descending ramp
Operators Manual
10-19
Theory of Operations
10.7.3
Pressure (cmH2O)
PEEP
Flow (L/min)
Inspiration phase
Volume (mL)
Expiration phase
Target pressure
VC+
VC+ breaths require initialization and must go through a startup routine.
VC+ Startup
During VC+ startup, the ventilator delivers at least one breath (test breath) to
determine the pressure target needed to deliver the desired (set) volume.
During the time the ventilator is delivering the test breaths, the message VC+
startup is displayed in the GUIs prompt area.
10-20
Note:
To allow for optimal function of startup and operation of VC+ in the ventilator it is
important not to block the tubing while the patient is undergoing suctioning or other
treatment that requires disconnection from the ventilator. The ventilator has a
disconnect detection algorithm that suspends ventilation while the patient is
disconnected.
Operators Manual
After VC+ Startup, the ventilator will make adjustments to the target pressure
in order to deliver the set volume (VT). In order to reach the desired volume
promptly, the maximum allowed pressure adjustments for an Adult or Pediatric
patient will be greatest during the first five breaths following Startup or a
change in VT or VT SUPP. The values of the maximum pressure adjustments for
each patient type are summarized below.
15 PBW < 25 kg
PBW < 15 kg
10.0 cmH2O
6.0 cmH2O
3.0 cmH2O
3.0 cmH2O
3.0 cmH2O
3.0 cmH2O
COMPLIANCE LIMITED VT
During VC+, inspiratory target pressure cannot be lower than PEEP + 3 cmH2O
and cannot exceed PPEAK - 3 cmH2O.
10.7.4
Rise time %
If PC or VC+ is selected as the Mandatory type, adjust rise time % for optimum
flow delivery into the lungs. Patients with high impedance (low compliance,
high resistance) may benefit from a lower rise time% whereas patients with
low impedance may better tolerate a more aggressive rise time setting. The rise
time % setting specifies the speed at which the inspiratory pressure reaches
Operators Manual
10-21
Theory of Operations
95% of the target pressure. The rise time setting applies to PS (including a
setting of 0 cmH2O), PC, or VC+ breaths. To match the flow demand of an
actively breathing patient, observe simultaneous pressure-time and flow-time
curves, and adjust the rise time % to maintain a smooth rise of pressure to the
target value. A rise time % setting reaching the target value well before the
end of inspiration can cause the ventilator to supply excess flow to the patient.
Whether this oversupply is clinically beneficial must be evaluated for each
patient. Generally, the optimum rise time % for gently breathing patients is
less than or equal to the default (50%), while optimum rise time % for more
aggressively breathing patients can be 50% or higher.
10.7.5
WARNING:
Under certain clinical circumstances (such as stiff lungs, or a small patient with
a weak inspiratory drive), a rise time % setting above 50% could cause a
transient pressure overshoot and premature transition to exhalation, or
pressure oscillations during inspiration. Carefully evaluate the patients
condition before setting the rise time % above the default setting of 50%.
Manual Inspiration
When pressed, the Manual Inspiration key delivers one OIM breath to the
patient, using set breath delivery parameters. The ventilator will not allow a
manual inspiration during the restricted phase of exhalation or when the ventilator is in the process of delivering a breath (whether mandatory or spontaneous). All manual inspiration attempts are logged in the General Event log.
The restricted phase of exhalation is the time period during the exhalation
phase where an inspiration trigger is not allowed. The restricted phase of exhalation is defined as the first 200 ms of exhalation OR the time it takes for expiratory flow to drop to 50% of the peak expiratory flow, OR the time it takes
for the expiratory flow to drop to 0.5 L/min (whichever is longest). The
restricted phase of exhalation will end after five (5) s of exhalation have elapsed
regardless of the measured expiratory flow rate.
10.8
10-22
Operators Manual
After selecting the spontaneous breath type, choose the level of pressure
support (PSUPP) for PS, Support volume (VT SUPP) for VS or percent support for
TC and PAV+ (if the PAV+ option is installed) and specify the rise time % and
ESENS, where available. Changes to the spontaneous breath type setting phase
in at the start of the next inspiration.
Note:
In any delivered spontaneous breath, either INVASIVE or NIV, there is always a target
inspiratory pressure of at least 1.5 cmH2O applied.
During spontaneous breathing, the patient's respiratory control center rhythmically activates the inspiratory muscles. The support type setting allows selection of pressure-assist to supplement the patient's pressure-generating
capability.
Table10-3.Spontaneous Breath Delivery Characteristics
Characteristic
Implementation
Inspiratory detection
Operators Manual
10-23
Theory of Operations
10-24
Implementation
Expiratory detection
Operators Manual
10.8.1
10.8.2
Rise time %
Technical Description
Volume Support (VS) breaths are patient-triggered, pressure-supported spontaneous breaths. The VS algorithm varies the inspiratory pressure of each
breath to deliver the operator-set target tidal volume (VT SUPP). If the delivered
volume for a breath is above or below the set target volume, VS adjusts the
target pressure for the next breath up or down, as necessary, to deliver more
or less volume. As the patient's condition improves allowing more patient
control over spontaneous ventilation, the VS algorithm decreases the amount
of inspiratory pressure necessary to deliver the target volume. Conversely, VS
increases inspiratory pressure if the patient's respiratory drive becomes compromised.
In the absence of leaks or changes in patient resistance or compliance, Volume
Support achieves and maintains a steady, breath-to-breath tidal volume within
five (5) breaths of VS initiation or startup.
During VS, the inspiratory pressure target cannot be lower than PEEP + 1.5
cmH2O, and cannot exceed PPEAK - 3 cmH2O.
Operators Manual
10-25
Theory of Operations
VS Startup
During startup, the ventilator delivers a breath (test breath) to determine the
pressure target needed to deliver the desired (set) volume. During the time the
ventilator is delivering the test breath, the message VS startup is displayed
in the GUIs prompt area.
Test breaths are defined as:
15 kg PBW < 25 kg
PBW < 15 kg
10.0 cmH2O
6.0 cmH2O
3.0 cmH2O
3.0 cmH2O
3.0 cmH2O
3.0 cmH2O
10-26
COMPLIANCE LIMITED VT
Operators Manual
Tube Compensation
Tube Compensation (TC) is a pressure-supported spontaneous breath type
available in SIMV, SPONT and BiLevel modes. When TC is enabled, the patients
respiratory muscles are not required to work as hard to draw gases into the
lungs as they would in the absence of the pressure assistance provided by the
TC feature. This is particularly important for patients whose respiratory systems
are already functioning poorly, and would have to exert even greater muscular
effort to overcome the increased resistance to flow through the artificial
airway.
Tube Compensation provides programmable, inspiratory pressure assistance
during otherwise unsupported spontaneous breaths. This assists the patient in
overcoming the flow resistance of the artificial airway. Pressure is programmed
to vary in accordance with the resistance to flow of the artificial airway. The
ventilator continuously calculates the pressure differential and adjusts the
compensation pressure accordingly.
Tube Compensation also includes safety protection, safety checks, and logic
checks which prevent the operator from entering certain incompatible settings, such as a large airway size paired with a small predicted body weight.
If the type of humidifier has been changed after running SST with TC, the
volume can be adjusted at the same time to avoid a reduction in compensation
compliance accuracy.
Technical Description
Tube Compensation is a spontaneous mode enhancement which assists
patients spontaneous breaths not already supported by specific pressurebased breath types (such as PS, VS, and PAV+) by delivering positive pressure
proportional to the flow-based, resistive pressure developed across the artificial airway. TC causes the sensation of breathing through an artificial airway
to diminish because the TC algorithm instructs the ventilator to develop just
the correct amount of forward pressure to offset (cancel) the back pressure
developed across the artificial airway during the inspiratory phase. The degree
Operators Manual
10-27
Theory of Operations
10-28
Operators Manual
WARNING:
Greater than expected ventilatory support, leading to unknown harm, can
result if the specified tube type or tube ID is smaller than the actual tube type
or tube ID.
Ventilator Settings/Guidelines
The estimation of settings to use with TC is aided by an understanding of: the
ventilator settings, the data used for determination of the compensation
values, and the specified performance or accuracy of the TC function.
The setting for 2PPEAK must take the estimated tube compensation into consideration. The target pressure (compensation) at the patient wye is derived
from the knowledge of the approximate airway resistance of the ET or tracheostomy tube being used. The compensation pressure in cmH2O for available
tube sizes and gas flows is shown. Reference ET Tube Target Pressure vs. Flow,
p. 10-30 and Reference Tracheostomy Tube Target Pressure vs. Flow, p. 10-31.
The estimated compensation must be added to the value of PEEP for calculation and setting of 2PPEAK.
Specified Performance
Performance using TC is specified to be (0.5 + 10% of actual) joules/liter
(residual work during inspiration at the 100% support (% Supp) level). Work
is computed over the entire inspiratory interval.
k P E END P TR V dt
W = -----------------------------------------------------------------V dt
Work [J/L]
PTR
Tracheal pressure
PE END
Operators Manual
10-29
Theory of Operations
The following figures indicate pressures at steady-state flows for ET tubes and
tracheostomy tubes, respectively, at 100% support at the wye for sizes
between 4.5 mm and 10 mm.
Figure10-11.ET Tube Target Pressure vs. Flow
10-30
Pressure (cmH2O)
Flow (L/min)
Operators Manual
10.8.4
Pressure (cmH2O)
Flow (L/min)
10.9
A/C Mode
When the ventilator is in assist-control (A/C) mode, only mandatory breaths
are delivered. These mandatory breaths can be PC, VC, or VC+ breaths. Reference Mandatory Breath Delivery, p. 10-17 for a more detailed explanation of
VC+ breaths. As for any mandatory breath, the triggering methods can be
P-TRIG, V-TRIG, time-triggered, or operator initiated. If the ventilator senses the
patient initiating the breath, a PIM or assist breath is delivered. Otherwise,
VIM breaths (control breaths) are delivered based on the set respiratory rate.
The length of the breath period is defined as
Operators Manual
10-31
Theory of Operations
where:
Tb = 60 f
T E = Tb T I
where:
TE = length of the expiratory phase (s)
TI = length of inspiratory phase(s) including plateau time, TPL
The figure shown below illustrates A/C breath delivery when there is no patient
inspiratory effort detected (all inspirations are VIMs).
Figure10-13.No Patient Inspiratory Effort Detected
10-32
VIM
Tb
Operators Manual
The figure below shows A/C breath delivery when patient inspiratory effort is
detected. The ventilator allows PIM breaths to be delivered at a rate greater
than or equal to the set respiratory rate.
Figure10-14.Patient Inspiratory Effort Detected
PIM
Tb set
The figure shown below illustrates A/C breath delivery when there are both
PIM and VIM breaths. delivered.
Figure10-15.Combined VIM and PIM Breaths
VIM
PIM
Tb set
If changes to the respiratory rate are made, they are phased in during exhalation only. The new breath period depends on the new respiratory rate, is based
on the start of the current breath, and follows these rules
A new inspiration is not delivered until at least 200 ms of exhalation have elapsed.
The maximum time t until the first VIM for the new respiratory rate is delivered is
3.5 times the current inspiratory time or the length of the new breath period
(whichever is longer), but t is no longer than the old breath period.
If the patient generates a PIM after the ventilator recognizes the rate change and
before time t, the new rate begins with the PIM.
Operators Manual
10-33
Theory of Operations
10.9.1
The ventilator ensures the apnea interval elapses at least five (5) s after the beginning of exhalation.
Any other specially scheduled event (for example, a respiratory mechanics maneuver or any pause maneuver) is canceled and rescheduled at the next interval.
When the first VIM of the new A/C mode is delivered depends on the mode
and breath type active when the mode change is requested.
10.10
SIMV Mode
Synchronous Intermittent Mandatory Ventilation (SIMV) mode is a mixed ventilation mode allowing both mandatory and spontaneous breaths using pressure- or flow-triggering. The mandatory breaths can be PC, VC, or VC+, and
the spontaneous breaths are pressure-assisted with either PS or TC. SIMV guarantees one mandatory breath per SIMV breath period, which is either a PIM or
VIM. OIM breaths are allowed in SIMV and are delivered at the setting selected
for Mandatory Type. Reference the figure below which shows the two parts of
the SIMV breath period.
Figure10-16.Mandatory and Spontaneous Intervals
10-34
Operators Manual
The first part of the period is the mandatory interval (Tm) which is reserved for
a PIM. If a PIM is delivered, the Tm interval ends and the ventilator switches to
the second part of the period, the spontaneous interval (Ts), which is reserved
for spontaneous breathing for the remainder of the breath period. At the end
of an SIMV breath period, the cycle repeats. If a PIM is not delivered during the
mandatory interval, the ventilator delivers a VIM at the end of the mandatory
interval, then switches to the spontaneous interval. The following figure shows
an SIMV breath period where a PIM is delivered within the mandatory interval.
Any subsequent trigger efforts during Ts yield spontaneous breaths. As shown,
Tm transitions to Ts when a PIM is delivered.
Figure10-17.PIM Delivered Within Mandatory Interval
PIM
Tb
The following figure shows an SIMV breath period where a PIM is not delivered
within the mandatory interval.
Figure10-18.PIM Not Delivered Within Mandatory Interval
Operators Manual
VIM
Ts
10-35
Theory of Operations
Tb
In SIMV, mandatory breaths are identical to those in A/C mode if the ventilators respiratory rate setting is greater than the patients natural respiratory
rate. Spontaneous breaths are identical to those in SPONT mode if the ventilator setting for respiratory rate is significantly below the patients natural respiratory rate. Patient triggering must meet the requirements for pressure and
flow sensitivity.
The procedure for setting the respiratory rate in SIMV is the same as in A/C
mode. Once the respiratory rate (f) is set, the SIMV interval period Tb in
seconds is
Tb = 60 f
During the mandatory interval, if the patient triggers a breath according to the
current setting for pressure or flow sensitivity, the ventilator delivers a PIM.
Once a mandatory breath is triggered, Tm ends, Ts begins, and any further
trigger efforts yield spontaneous breaths. During the spontaneous interval, the
patient can take as many spontaneous breaths as allowed. If no PIM or OIM is
delivered by the end of the mandatory interval, the ventilator delivers a VIM
and transitions to the spontaneous interval at the beginning of the VIM.
The SIMV breathing algorithm delivers one mandatory breath each period
interval, regardless of the patients ability to breathe spontaneously. Once a
PIM or VIM is delivered, all successful patient efforts yield spontaneous breaths
until the cycle interval ends. The ventilator delivers one mandatory breath
during the mandatory interval, regardless of the number of successful patient
efforts detected during the spontaneous interval. (An OIM delivered during the
mandatory interval satisfies the mandatory breath requirement, and causes Tm
to transition to Ts.)
The maximum mandatory interval for any valid respiratory rate setting in SIMV
is defined as the lesser of
ten s.
10-36
Operators Manual
+ ten (10) s. At high respiratory rates and too-large tidal volumes, breath
stacking (the delivery of a second inspiration before the first exhalation is
complete) is likely. In volume ventilation, breath stacking during inspiration
and early exhalation leads to hyperinflation and increased airway and lung
pressures, which can be detected by a high pressure limit alarm. In pressure
control ventilation (with inspiratory pressure remaining constant), breath
stacking leads to reduced tidal volumes, which can be detected by the low tidal
volume and minute ventilation alarms.
In SIMV mode it is possible for the respiratory rate to drop temporarily below
the f setting (unlike A/C mode, in which fTOT is always greater than or equal to
the f setting). If the patient triggers a breath at the beginning of a breath
period, then does not trigger another breath until the maximum mandatory
interval for the following breath has elapsed, a monitored respiratory rate less
than the respiratory rate setting can result.
If a spontaneous breath occurs toward the end of the spontaneous interval,
inspiration or exhalation can still be in progress when the SIMV interval ends.
No VIM, PIM, or OIM is allowed during the restricted phase of exhalation. In
the extreme, one or more expected mandatory breaths could be omitted.
When the expiratory phase of the spontaneous breath ends, the ventilator
reverts to its normal criteria for delivering mandatory breaths.
If an OIM is detected during the mandatory interval, the ventilator delivers the
currently specified mandatory breath then closes Tm and transitions to Ts. If an
OIM is detected during the spontaneous interval, the ventilator delivers the
currently specified mandatory breath, but the SIMV cycle timing does not
restart if OIM breaths are delivered during Ts.
10.10.1
The VIM breath is not delivered during an inspiration or during the restricted
phase of exhalation.
If the current mode is A/C, the first SIMV VIM is delivered after the restricted phase
of exhalation plus the shortest of the following intervals, referenced to the beginning of the last or current inspiration: 3.5 TI, current TA, or the length of the
current breath period.
Operators Manual
10-37
Theory of Operations
If the current mode is SPONT, and the current or last breath type was spontaneous
or OIM, the first SIMV VIM is delivered after the restricted phase of exhalation plus
the shortest of the following intervals, referenced to the beginning of the last or
current inspiration: 3.5 x TI, or current TA.
If the current mode is BiLevel in the PH state and the current breath is mandatory,
the PEEP level will be reduced to PL once the exhalation phase is detected
The time t until the first VIM of the new A/C mode is the lesser of:
PEEP transition time + 2.5 x duration of the active gas delivery phase, or
If the current mode is BiLevel in the PH state and the current breath is spontaneous:
the PEEP level will be reduced once the exhalation phase is detected
The time t until the first VIM of the new A/C mode is the lesser of:
10-38
the start time of the spontaneous breath + the length of the apnea interval
(TA).
If the current mode is BiLevel in the PL state and the current breath is mandatory,
the time t until the first VIM of the new A/C mode is the lesser of:
PEEP transition time + 2.5 x duration of the active gas delivery phase, or
If the current mode is BiLevel in the PL state and the current breath is spontaneous
and the spontaneous start time has occurred during PL, the time t until the first
VIM of the new A/C mode is the lesser of:
Operators Manual
If the current mode is BiLevel in the PL state and the current breath is spontaneous
and the spontaneous start time has occurred during PH, the time t until the first
VIM of the new A/C mode is the lesser of:
the start time of the spontaneous breath + the length of the apnea interval
(TA).
If the command to change to SIMV occurs after the restricted phase of exhalation has ended, and before a next breath or the apnea interval has elapsed,
the ventilator delivers the first SIMV VIM at the moment the command is recognized.
The point at which the new rate is phased in depends on the current phase of
the SIMV interval and when the rate change command is accepted. If the rate
change occurs during the mandatory interval, the maximum mandatory interval is that for the new or old rate, whichever is less. If the patient generates a
successful inspiratory effort during the spontaneous interval, the ventilator
responds by delivering a spontaneous breath.
Respiratory rate changes are phased in during exhalation only. The new SIMV
interval is determined by the new respiratory rate and is referenced to the start
of the current SIMV period interval, following these rules:
The new inspiration is not delivered until 200 ms of exhalation have elapsed.
10.11
whichever is greater: the new SIMV period interval or 3.5 x the last or current TI,
PS
VS
TC
Operators Manual
10-39
Theory of Operations
The inspiratory phase begins when the ventilator detects patient effort during
the ventilators exhalation phase. Breath delivery during the inspiratory phase
is determined by the settings for pressure support, PEEP, rise time%, and expiratory sensitivity, unless the breath is an OIM breath.
If Tube Compensation (TC), or Proportional Assist Ventilation (PAV+) (if the
PAV+, option is installed) is selected as the spontaneous type, breath delivery
during the inspiratory phase is determined by the settings for% support (%
Supp), expiratory sensitivity, tube ID, and tube type.
Note:
Given the current ventilator settings, if PAV+ would be an allowable spontaneous type
(except that tube ID < 6 mm) then PAV+ becomes selectable. If selected, tube ID is set
to its New Patient default value based on the PBW entered. An attention icon for tube
ID appears.
10.11.1
1PPEAK
10-40
Operators Manual
ments, the ventilator then enters the exhalation phase and waits for the detection of patient inspiratory effort, a manual inspiration, or apnea detection.
10.12
Apnea Ventilation
When a patient stops breathing or is no longer being ventilated, it is called
apnea. When apnea is detected by the ventilator the ventilator alarms and
delivers apnea ventilation according to the current apnea ventilation settings.
10.12.1
Apnea Detection
The ventilator declares apnea when no breath has been delivered by the time
the operator-selected apnea interval elapses, plus a small increment of time
(350 ms). This increment allows time for a patient who has begun to initiate a
breath to trigger inspiration and prevent the ventilator from declaring apnea
when the apnea interval is equal to the breath period.
The apnea timer resets whenever an inspiration begins, regardless of whether
the inspiration is patient-triggered, ventilator-triggered, or operator-initiated.
The ventilator then sets a new apnea interval beginning from the start of the
current inspiration. To hold off apnea ventilation, another inspiration must be
delivered before (the current apnea interval + 350 ms) elapses. Apnea detection is suspended during a disconnect, occlusion, or safety valve open (SVO)
state.
Apnea is not declared when the apnea interval setting equals or exceeds the
breath period. For example, if the respiratory rate setting is 4/min, an apnea
interval of 15 s or more means apnea cannot be detected. The ventilator bases
apnea detection on inspiratory (not expiratory) flow, and allows detection of a
disconnect or occlusion during apnea ventilation. Apnea detection is designed
to accommodate interruptions to the typical breathing pattern due to other
ventilator features that temporarily extend the inspiratory or expiratory intervals (rate changes, for example) but still detect a true apnea event.
The following figure shows an apnea breath where TA equals the breath
period.
Operators Manual
10-41
Theory of Operations
Tb0
PIM
Tb1
TA (apnea interval)
The figure below shows an apnea breath with TA greater than the breath
period.
Figure10-20.Apnea Interval Greater Than Breath Period
Tb0
VIM
Tb1
TA (apnea interval)
PIM
The following figure shows an apnea breath with TA less than the breath
period.
10-42
Operators Manual
Tb0
Apnea interval
Tb1
Apnea Tb0
PIM
Apnea ventilation
Tb (TA<Tb)
Apnea VIM
10.12.2
10.12.3
Operators Manual
10-43
Theory of Operations
10.12.5
If the apnea interval (TA) elapses at any time during the mandatory interval, the
ventilator delivers a VIM rather than beginning apnea ventilation.
10-44
Operators Manual
10.12.6
Tb
TA
VIM
Ts
Tm max
10.13
10.13.1
If the new apnea interval setting is shorter than the current (or temporarily extended) apnea interval, the new value is implemented at the next inspiration.
If the new apnea interval setting is longer than the current (or temporarily extended) apnea interval, the old interval is extended to match the new interval immediately.
Operators Manual
10-45
Theory of Operations
The ventilator EXHAUST port is blocked or resistance through the port is too high.
The exhalation valve fails in the closed position (occlusion detection at the From
patient port begins after 195 ms of exhalation has passed.)
The pressure difference between the inspiratory and the expiratory transducers is
less than or equal to 5 cmH2O.
The exhalation valve fails in the closed position and the pressure in the exhalation
limb is less than 2 cmH2O.
Silicone tubing is attached to the EXHAUST port of the ventilator (i.e. for metabolic monitoring purposes).
The ventilator checks the patient circuit for occlusions during all modes of
breathing (except Stand-by state and Safety Valve Open) at delivery of every
breath. Once the circuit check begins, the ventilator detects a severe occlusion
of the patient circuit within 200 ms. The ventilator checks the EXHAUST port
for occlusions during the expiratory phase of every breath (except during disconnect and safety valve open). Once the EXHAUST port check begins, the
ventilator detects a severe occlusion within 100 ms following the first 200 ms
of exhalation. All occlusion checking is disabled during pressure sensor autozeroing.
When an occlusion is detected, an alarm sounds, the ventilator enters the OSC
(Occlusion Status Cycling) state and displays a message indicating the length
of time the patient has gone without ventilation (how long the ventilator has
been in OSC). This alarm has the capability to autoreset, since occlusions such
as those due to patient activity (for example, crimped, or kinked tubing) can
correct themselves.
Once a severe occlusion is detected, the ventilator acts to minimize airway
pressure. Because any severe occlusion places the patient at risk, the ventilator
minimizes the risk while displaying the length of time the patient has been
without ventilatory support. Severe occlusion is detected regardless of what
mode or triggering strategy is in effect. When a severe occlusion is detected,
the ventilator terminates normal ventilation, terminates any active alarm
silence, annunciates an occlusion alarm, and enters the safe state (exhalation
and inspiratory valve de-energized and safety valve open) for 15 s or until inspiratory pressure drops to 5 cmH2O or less, whichever comes first.
10-46
Operators Manual
Disconnect
A circuit disconnect condition is detected when the ventilator cannot ensure
that a patient is receiving sufficient tidal volume (due to a large leak or disconnected patient circuit). This discussion applies when Leak Sync is disabled.
When a disconnect is detected, an alarm sounds, the ventilator indicates that
a disconnect has been detected, and displays a message indicating the length
of time the patient has gone without ventilation.
Patient data are not displayed during a circuit disconnect condition.
The ventilator monitors the expiratory pressure and flow, delivered volume,
and exhaled volume to declare a disconnect using any of these methods
Operators Manual
The ventilator detects a disconnect when the expiratory pressure transducer measures no circuit pressure and no exhaled flow during the first 200 ms of exhalation. The ventilator postpones declaring a disconnect for another 100 ms to allow
an occlusion (if detected) to be declared first, because it is possible for an occlusion to match the disconnect detection criteria.
10-47
Theory of Operations
If the disconnect occurs at the endotracheal tube, the exhaled volume will be
much less than the delivered volume for the previous inspiration. The ventilator
declares a disconnect if the exhaled volume is lower than the DSENS setting for
three consecutive breaths. The DSENS setting helps avoid false detections due to
leaks in the circuit or the patients lungs, and the three-consecutive-breaths
requirement helps avoid false detections due to a patient out-drawing the ventilator during volume control (VC) breaths.
Flow less than a value determined using the DSENS setting and pressure less than
0.5 cmH2O detected for ten (10) consecutive seconds during exhalation.
WARNING:
When vent type is NIV, and DSENS setting is turned OFF, the system may not
detect large leaks and some disconnect conditions it would declare as alarms
during INVASIVE ventilation.
Once the ventilator detects a patient circuit disconnect, the ventilator declares
a high-priority alarm and discontinues breath delivery, regardless of what
mode (including apnea) was active when the disconnect was detected. If there
is an active alarm silence when the disconnect occurs, the alarm silence is NOT
cancelled. The ventilator displays the length of time the patient has been
without ventilatory support. During the disconnect, the exhalation valve closes,
idle flow (10 L/min flow at 100% O2 or 40% O2 in NeoMode, if available with
Leak Sync disabled and 20 L/min with Leak Sync enabled) begins, and breath
triggering is disabled. A message appears identifying how long the patient has
gone without ventilatory support.
The ventilator monitors both expiratory flow and circuit pressures to detect
reconnection. The ventilator declares a reconnect if any of the following criteria are met for the applicable time interval:
10-48
Inspiratory and expiratory pressures are both above or both below reconnect
threshold levels or,
Operators Manual
10.14
Respiratory Mechanics
Reference Respiratory Mechanics Maneuvers, p. 4-28 for instructions on how
to perform these maneuvers.
In addition to Inspiratory Pause and Expiratory Pause maneuvers, the ventilator
can provide other respiratory maneuvers, including Negative Inspiratory Force
(NIF), Occlusion Pressure (P0.1) and Vital Capacity (VC), as well as automatic calculations of lung function and performance, such as Dynamic Compliance
(CDYN) and Dynamic Resistance (RDYN), Peak Expiratory Flow (PEF), End Expiratory Flow (EEF), C20/C, and Peak Spontaneous Flow (PSF).
Respiratory maneuvers can be performed in all breathing modes (except as
noted below) but are not available during the following conditions:
Apnea ventilation
Safety PCV
Operators Manual
10-49
Theory of Operations
SVO
When any other respiratory maneuver has already taken place during the same
breath
The GUI also displays any maneuver request, distinguishing between requests
that are accepted or rejected, and any maneuver that has begun, ended, or has
been canceled.
When a maneuver is selected, a GUI information panel is opened, displaying
the maneuver name, user prompts and controls, and recent calculated results.
Any maneuver is canceled automatically upon declaration of any of the following alarms:
1PPEAK alarm
1PVENT alarm
1VTI
10.14.1
Occlusion Pressure
VC Vital Capacity
Inspiratory Pause
Note:
Inspiratory pause and expiratory pause maneuvers can be performed directly by
pressing the respective keys on the GUI or by swiping the Menu tab on the left side
of the GUI. For more information on how to perform Respiratory Mechanics
Maneuvers from the Menu tab, Reference Respiratory Mechanics Maneuvers, p. 4-28.
10-50
Operators Manual
static resistance of the respiratory system (RSTAT), and inspiratory plateau pressure (PPL). To calculate these pressures, the inspiratory and exhalation valves
are closed, allowing pressures on both sides of the artificial airway to equalize,
revealing the actual lung inflation pressure during a no-flow condition. An
inspiratory pause can be either automatically or manually administered, and is
only available during the next mandatory breath in A/C, SIMV, BiLevel or
SPONT modes. In BiLevel, an inspiratory pause maneuver is scheduled for the
next inspiration prior to a transition from PH to PL. Only one inspiratory pause
is allowed per breath. An inspiratory pause cannot occur during apnea ventilation, safety PCV, Stand-by state, Occlusion, and SVO.
An automatic inspiratory pause begins when the inspiratory pause key is
pressed momentarily or the maneuver is started from the GUI screen. Reference To access respiratory mechanics maneuvers, p. 4-28 for more information
on performing respiratory mechanics maneuvers from the Menu tab on the
GUI rather than using the keys on the GUI. The pause lasts at least 0.5 second
but no longer than three(3) s. A manual inspiratory pause starts by pressing
and holding the inspiratory pause key. The pause lasts for the duration of the
key press (up to seven(7) s).
An active manual inspiratory pause is considered complete if any of the following occur:
The inspiratory pause key is released and at least two seconds of inspiratory pause
have elapsed or pressure stability conditions have been detected for not less than
0.5 s.
A manual inspiratory pause maneuver request (if the maneuver is not yet
active) will be canceled if any of events1-10 occur. Reference Inspiratory and
Expiratory Pause Events.
Table10-5.Inspiratory and Expiratory Pause Events
Event Identifier
Operators Manual
Event
A disconnect is detected
Occlusion is detected
10-51
Theory of Operations
Event
Apnea is detected
10
11
12
13
14
BUV is entered
15
10-52
Operators Manual
During an inspiratory pause, the apnea interval (TA) is extended by the duration of
the inspiratory pause.
If the ventilator is in SIMV, the breath period during which the next scheduled VIM
occurs will also be extended by the amount of time the inspiratory pause is active.
All activations of the inspiratory pause control are logged in the Patient Data Log.
When calculating I:E ratio, inspiratory pause is considered part of the inspiration
phase.
The expiratory time remains unchanged, and will result in a change in the I:E ratio
for the breath that includes the inspiratory phase.
Once the inspiratory Pause maneuver is completed the operator can review the
quality of the maneuver waveform and accept or reject the maneuver data.
10.14.2
Expiratory Pause
An expiratory pause extends the exhalation phase of a single breath in order
to measure end expiratory lung pressure (PEEPTOT) and allows intrinsic PEEP
(PEEPI) to be calculated as PEEPTOT minus set PEEP. The pressures on either side
of the artificial airway are allowed to equalize by closing the inspiratory and
exhalation valves. Expiratory pause is available in A/C, SIMV, and BiLevel
modes. For A/C and SIMV, the expiratory pause maneuver is scheduled for the
next end-of-exhalation prior to a mandatory breath. In BiLevel, the expiratory
pause occurs at the next end-of-exhalation prior to a transition from PL to PH.
Only one expiratory pause per breath is allowed, and the expiratory pause
request is rejected if an inspiratory pause has already taken place during the
same breath.
A request for an expiratory pause maneuver is ignored in apnea ventilation,
safety PCV, SPONT, OSC, BUV, and Stand-by. Reference To access respiratory
mechanics maneuvers, p. 4-28 for more information on performing these
maneuvers from the GUI screen rather than using the keys on the GUI.
Either manual or automatic expiratory pause maneuvers can occur. A
momentary press of the expiratory pause key begins an automatic expiratory
pause which lasts at least 0.5 s, but no longer than 3.0 s. A manual expiratory
pause starts by pressing and holding the expiratory pause key and lasts for the
duration of the key-press (up to 15 s).
Operators Manual
10-53
Theory of Operations
When calculating I:E ratio, the expiratory pause is considered part of the exhalation phase.
During the expiratory pause, the inspiratory time remains unchanged, so the I:E
ratio is changed for the breath that includes the expiratory pause.
All activations of the expiratory pause control are logged in the Patient Data log.
Once the expiratory pause maneuver is completed the operator can review the
quality of the maneuver waveform and accept or reject the maneuver data.
10.14.3
10-54
Disconnect is detected
Occlusion is detected
Operators Manual
SVO is detected
The maneuver has been active for 30 s and an inspiration is not detected
Disconnect is detected
Occlusion is detected
SVO is detected
Operators Manual
10-55
Theory of Operations
10.14.5
10-56
Disconnect is detected
Occlusion is detected
SVO is detected
Operators Manual
10.15.1
Ventilator Settings
Apnea Ventilation
Apnea ventilation is a backup mode and starts if the patient fails to breathe
within the apnea interval (TA) set by the operator. TA defines the maximum
allowable length of time between the start of inspiration and the start of the
next inspiration. Available settings include mandatory type (PC or VC). For PC
breaths the allowable settings are
Flow pattern
O2 %
During apnea ventilation with PC selected as the mandatory type, rise time %
is fixed at 50%, and the constant parameter during a rate change is inspiratory
time (TI).
If apnea is possible (that is, if (60/f) > TA) increasing the non-apnea O2%
setting automatically changes apnea ventilation O2% if it is not already set
higher than the new non-apnea O2%. Apnea ventilation O2% does not automatically change by decreasing the non-apnea O2%. Whenever there is an
Operators Manual
10-57
Theory of Operations
automatic change to an apnea setting, a message appears on the GUI, and the
apnea settings screen appears.
During apnea ventilation, changes to all non-apnea ventilation settings are
allowed, but the new settings do not take effect until the ventilator resumes
normal ventilation. Being able to change TA during apnea ventilation can avoid
immediately re-entering apnea ventilation once normal ventilation resumes.
Because the minimum value for TA is ten (10) s, apnea ventilation cannot take
place when non-apnea f is greater than or equal to 5.8/min.The ventilator does
not enter apnea ventilation if TA is equal to the breath period interval. Set TA
to a value less than the expected or current breath period interval as a way of
allowing the patient to initiate breaths while protecting the patient from the
consequences of apnea.
10.15.2
Circuit Type
Minimum VT
Neonatal
2 mL if NeoMode 2.0
software option is
installed
315 mL
Pediatric
25 mL
1590 mL
Adult
25 mL
2500 mL
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Operators Manual
Neonatal
30 L/min
Pediatric
60 L/min
Adult
150 L/min
Vent Type
There are two Vent Type choices INVASIVE and NIV (non-invasive). INVASIVE
ventilation is conventional ventilation used with endotracheal or tracheostomy
tubes. All installed software options, breathing modes, breath types, and
trigger types are available during INVASIVE ventilation.
NIV interfaces include non-vented full-faced or nasal masks or nasal prongs.
Reference NIV Breathing Interfaces, p. 4-22 for a list of interfaces that have
been successfully tested with NIV).
NIV enables the ventilator to handle large system leaks associated with these
interfaces by providing pressure-based disconnect alarms, minimizing false disconnect alarms, and replacing the INSPIRATION TOO LONG alarm with a High
Spontaneous Inspiratory Time limit (2TI SPONT) setting and visual indicator.
The following list shows the subset of INVASIVE settings active during NIV:
During NIV alarm setup, the clinician may set alarms to OFF and must determine if doing so is appropriate for the patients condition.
Operators Manual
10-59
Theory of Operations
10.15.4
Mode
Mandatory Breath
Type
A/C
Spontaneous Breath
Type
Sequence
Not allowed
NIV: VC or PC
SIMV
SPONT
PC
PS, TC
VC or PC (allowed only
for OIM breaths)
N/A
BiLevel
(INVASIVE
vent type
only)
CPAP
Breath types must be defined before settings can be specified. There are only
two categories of breath type: mandatory and spontaneous. Mandatory
breaths are volume controlled (VC) or pressure controlled (PC or VC+). The
ventilator currently offers spontaneous breaths that are pressure supported
(PS) volume supported (VS), tube compensated (TC), or proportionally assisted
(PAV+), if the PAV+ option is installed. The figure below shows the modes and
breath types available on the ventilator.
10-60
Operators Manual
A/C,
SIMV,
SPONT,
BiLevel
Mandatory
PC
VC
Spontaneous
VC+
PS
TC
VS
PAV+
The mode setting defines the interaction between the ventilator and the
patient.
Spontaneous (SPONT) mode allows the patient to control ventilation. The patient
must be able to breathe independently, and exert the effort to trigger ventilator
support.
BiLevel is a mixed mode that combines both mandatory and spontaneous breath
types. Breaths are delivered in a manner similar to SIMV mode with PC selected,
but providing two levels of pressure. The patient is free to initiate spontaneous
breaths at either pressure level during BiLevel.
Changes to the mode are phased in at the start of inspiration. Mandatory and
spontaneous breaths can be flow- or pressure-triggered, or IE Sync triggered
(if the IE Sync software option is installed).
The ventilator automatically links the mandatory type setting to the mode setting. During A/C or SIMV modes, once the operator has specified volume or
pressure, the ventilator displays the appropriate breath parameters. Changes
in the mandatory type are phased in at the start of inspiration.
10.15.5
Operators Manual
10-61
Theory of Operations
matically determines the other timing variables. Reference Inspiratory Time (TI),
p. 10-65 for an explanation of the interdependencies of f, TI, TE, and I:E.
Changes to the f setting are phased in at the start of inspiration.
The ventilator does not accept a proposed f setting if it would cause the new
TI or TE to be less than 0.2 second, the TI to be greater than eight(8) s, or I:E
ratio greater than 4.00:1. (The ventilator also applies these restrictions to a proposed change to the apnea respiratory rate, except that apnea I:E cannot
exceed 1.00:1. An exception to this rule occurs in BiLevel ventilation where the
proposed f setting will allow the I:E ratio to be greater than 4.00:1 only until
the minimum TL is reached.
10.15.6
10.15.7
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Operators Manual
10.15.8
10.15.9
Flow Pattern
The flow pattern setting defines the gas flow pattern of volume-controlled
(VC) mandatory breaths only. The selected values for VT and VMAX apply to
both the square or descending ramp flow patterns. If VT and VMAX and are
held constant, TI approximately halves when the flow pattern changes from
descending ramp to square (and approximately doubles when flow pattern
changes from square to descending ramp), and corresponding changes to the
I:E ratio also occur. Changes in flow pattern are phased in at the start of inspiration.
The settings for flow pattern, VT,f, TPL, and VMAX are interrelated. If any setting
change would cause any of the following, the ventilator does not allow that
change
TE < 0.2 s
10.15.10 Flow
Sensitivity (VSENS)
The VSENS setting defines the rate of flow inspired by a patient that triggers the
ventilator to deliver a mandatory or spontaneous breath. When V-TRIG is selected, a base flow of gas (1.5 L/min) travels through the patient circuit during the
Operators Manual
10-63
Theory of Operations
ventilators expiratory phase. Once a value for flow sensitivity is selected, the
ventilator delivers a base flow equal to VSENS + 1.5 L/min (base flow is not userselectable). When the patient inhales and their inspiratory flow exceeds the
VSENS setting, a trigger occurs and the ventilator delivers a breath. Reductions
to VSENS are phased in immediately, while increases are phased in at the start
of exhalation.
When VSENS is active, it replaces pressure sensitivity (PSENS). The VSENS setting
has no effect on the PSENS setting. VSENS can be active in any ventilation mode
(including pressure supported, volume controlled, pressure controlled, and
apnea ventilation). When VSENS is active, a backup PSENS setting of 2 cmH2O is
in effect to detect the patient's inspiratory effort, even if the flow sensors do
not detect flow.
Although the minimum VSENS setting of 0.2 L/min (adult/pediatric circuit types)
or 0.1 L/min (neonatal circuit type) can result in autotriggering, it can be appropriate for very weak patients. The maximum setting of 20 L/min (adult/pediatric
circuit types) or 10 L/min (neonatal circuit type) is intended to avoid autotriggering when there are significant leaks in the patient circuit.
10.15.11 Pressure
Sensitivity (PSENS)
The PSENS setting selects the pressure drop below baseline (PEEP) required to
begin a patient-initiated breath (either mandatory or spontaneous). Changes
to PSENS are phased in immediately. The PSENS setting has no effect on the
VSENS setting and is active only if the trigger type is P-TRIG.
Lower PSENS settings provide greater patient comfort and require less patient
effort to initiate a breath. However, fluctuations in system pressure can cause
autotriggering at very low settings. The maximum PSENS setting avoids autotriggering under worst-case conditions if patient circuit leakage is within specified limits.
10.15.12 Inspiratory
Pressure (PI)
The PI setting determines the pressure at which the ventilator delivers gas to
the patient during a PC mandatory breath. The PI setting only affects the delivery of PC mandatory breaths. The selected PI is the pressure above PEEP. (For
example, if PEEP is set to five cmH2O, and PI is 20 cmH2O, the ventilator deliv-
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ers gas to the patient at 25 cmH2O.) Changes to the PI setting are phased in
at the start of inspiration.
The sum of PEEP + PI + 2 cmH2O cannot exceed the high circuit pressure
(2PPEAK) limit. To increase this sum of pressures, first raise the 2PPEAK limit
before increasing the settings for PEEP or PI. The minimum value for PI is 5
cmH2O and the maximum value is 90 cmH2O.
10.15.13 Inspiratory
Time (TI)
60
T I = ------ I :E 1 + I :E
f
If the f setting remains constant, any one of the three variables (TI, I:E, or TE)
can define the inspiratory and expiratory intervals. If the f setting is low (and
additional spontaneous patient efforts are expected), TI can be a more useful
variable to set than I:E. As the f setting increases (and the fewer patient-triggered breaths are expected), the I:E setting becomes more relevant. Regardless
of which variable is chosen, a breath timing bar always shows the interrelationship between TI, I:E,TE, and f.
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Theory of Operations
10.15.14 Expiratory
Time (TE)
The TE setting defines the duration of exhalation for PC and VC+ mandatory
breaths, only. Changes to the TE setting are phased in at the start of exhalation. Setting f and TE automatically determines the value for I:E ratio and TI.
Reference Inspiratory Time (TI), p. 10-65 for an explanation of the interdependencies of f, TI, TE, and I:E.
10.15.15 I:E
Ratio
The I:E ratio setting is available when I:E is selected as the constant during rate
change. The I:E setting determines the ratio of inspiratory time to expiratory
time for mandatory PC breaths. The ventilator accepts the specified range of
direct I:E ratio settings as long as the resulting TI and TE settings are within the
ranges established for mandatory breaths. Changes to the I:E ratio phase in at
the start of inspiration. Directly setting the I:E ratio in VC mandatory breaths is
not allowed. Reference Inspiratory Time (TI), p. 10-65 for an explanation of the
interdependencies of f, TI, TE, and I:E.
Setting f and I:E automatically determine the values for TI and TE. The
maximum I:E ratio setting of 4.00:1 is the maximum that allows adequate time
for exhalation and is intended for inverse ratio pressure control ventilation.
10.15.16 High
The pressure level entered by the operator for the inspiratory phase of the
mandatory breath in BiLevel ventilation.
10.15.17 Low
The pressure level entered by the operator for the expiratory phase of the mandatory breath in BiLevel ventilation.
10.15.18 High
The duration of time (in seconds) the ventilator maintains the set high pressure
level in BiLevel ventilation.
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Operators Manual
10.15.19 Low
The duration of time (in seconds) the ventilator maintains the set low pressure
level in BiLevel ventilation.
10.15.20 TH:TL
Ratio in BiLevel
This setting defines the positive end-expiratory pressure (PEEP), also called
baseline airway pressure. PEEP is the positive pressure maintained in the
patient circuit during exhalation. Changes to the PEEP setting are phased in at
the start of exhalation.
The sum of
PEEP + 7 cmH2O, or
cannot exceed the 2PPEAK limit. To increase the sum of pressures, first raise the
2PPEAK limit before increasing the settings for PEEP, PI, or PSUPP.
If there is a loss of PEEP from occlusion, disconnect, Safety Valve Open, or loss
of power conditions, PEEP is re-established (when the condition is corrected)
by the ventilator delivering a PEEP restoration breath. The PEEP restoration
breath is a 1.5 cmH2O pressure-supported breath with exhalation sensitivity of
25%, and rise time % of 50%. A PEEP restoration breath is also delivered at
the conclusion of Vent Startup. After PEEP is restored, the ventilator resumes
breath delivery at the current settings.
Note:
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Theory of Operations
10.15.22 Pressure
Support (PSUPP)
The PSUPP setting determines the level of positive pressure above PEEP applied
to the patient's airway during a spontaneous breath. PSUPP is only available in
SIMV, SPONT, and BiLevel, in which spontaneous breaths are allowed. The
PSUPP setting is maintained as long as the patient inspires, and patient demand
determines the flow rate. Changes to the PSUPP setting are phased in at the
start of inspiration. The pressure support setting affects only spontaneous
breaths.
The sum of PEEP +PSUPP +2 cmH2O cannot exceed the 2PPEAK limit. To increase
the sum of pressures, first raise the 2PPEAK limit before increasing the settings
for PEEP or PSUPP. Since the 2PPEAK limit is the highest pressure considered safe
for the patient, a PSUPP setting that would cause a 1PPEAK alarm requires reevaluating the maximum safe circuit pressure.
10.15.23 Volume
Volume support (VT SUPP) is defined as the volume of gas delivered to the
patient during spontaneous VS breaths. Changes to the to the VT SUPP setting
are phased in at the start of inspiration.
10.15.24 %
Supp in TC
In TC, the% Supp setting represents the amount of the imposed resistance of
the artificial airway the TC breath type will eliminate by applying added pressure at the patient circuit wye. For example, if the % Supp setting is 100%, TC
eliminates 100% of the extra work imposed the by the airway. At 50%, TC
eliminates 50% of the added work from the airway. TC is also used with BiLevel, and is available during both PH and PL phases.
10.15.25 %
Supp in PAV+
In PAV+, the % Supp setting represents the percentage of the total work of
breathing provided (WOB) by the ventilator. Higher inspiratory demand yields
greater support from the ventilator. The patient performs the remaining work.
If the total WOB changes (resulting from a change to resistance or compliance)
the percent support remains constant.
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10.15.26 Rise
Time %
The rise time % setting allows adjustment of the speed at which the inspiratory
pressure reaches 95% of the target pressure. Rise time settings apply to PS
(including a setting of 0 cmH2O),VS, PC, or VC+ breaths. The higher the value
of rise time %, the more aggressive (and hence, the more rapid) the rise of
inspiratory pressure to the target (which equals PEEP + PI (or PSUPP)). The rise
time % setting only appears when pressure-based breaths are available. The
range of rise time % is 1% to 100%. A setting of 50% takes approximately
half the time to reach 95% of the target pressure as a setting of 1.
For mandatory PC, VC+, or BiLevel breaths, a rise time setting of 1 produces a
pressure trajectory reaching 95% of the inspiratory target pressure (PEEP + PI) in
two (2) s or 2/3 of the TI, whichever is shortest.
For spontaneous breaths (VS, or PS), a rise time setting of 1 produces a pressure
trajectory reaching 95% of the inspiratory target (PEEP + PSUPP) in (0.4 x PBWbased TI TOO LONG x 2/3) s.
When both PC and PS breaths are active, the slopes and thus the pressure trajectories can appear to be different. Changes to TI and PI cause PC pressure trajectories to change. Changes in rise time % are phased in at the start of inspiration.
When PSUPP = 0, the rise time % setting determines how quickly the ventilator
drives circuit pressure to PEEP + 1.5 cmH2O.
10.15.27 Expiratory
Sensitivity (ESENS)
The ESENS setting defines the percentage of the measured peak inspiratory
flow at which the ventilator cycles from inspiration to exhalation in all spontaneous breath types unless IE Sync has been selected for inspiratory and expiratory detection. When inspiratory flow falls to the level defined by ESENS,
exhalation begins. ESENS is a primary setting and is accessible from the GUI
screen. Changes to ESENS are phased in at the next patient-initiated spontaneous inspiration.
ESENS complements rise time %. Rise time % should be adjusted first to match
the patient's inspiratory drive, and then the ESENS setting should cause ventilator exhalation to occur at a point most appropriate for the patient. The higher
the ESENS setting, the shorter the inspiratory time. Generally, the most appropriate ESENS is compatible with the patient's condition, neither extending nor
shortening the patient's intrinsic inspiratory phase.
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Theory of Operations
Sensitivity (DSENS)
Note:
If DSENS is set to OFF during NIV, the ventilator is still capable of declaring a CIRCUIT
DISCONNECT alarm.
Note:
DSENS cannot be turned OFF if Leak Sync is enabled.
The high spontaneous inspiratory time limit setting (2TI SPONT) is available only
in SIMV or SPONT modes during NIV, and provides a means for setting a
maximum inspiratory time after which the ventilator automatically transitions
to exhalation. The default 2TI SPONT setting is based upon circuit type and PBW.
For pediatric/adult circuit types, the new patient default value is (1.99 + (0.02
x PBW)) s
For neonatal circuit types, the new patient default value is ((1.00 + (0.10 x
PBW) s
The 1TI SPONT indicator appears on the primary display at the beginning of a
ventilator-initiated exhalation and remains visible for as long as the ventilator
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truncates breaths in response to the 2TI SPONT setting. The 1TI SPONT indicator
disappears when the patients inspiratory time returns to less than the 2TI
SPONT setting, or after 15 seconds has elapsed after the beginning of exhalation
of the last truncated breath. Changes to 2TI SPONT are phased in at the start of
inspiration.
10.15.30 Humidification
Type
The humidification type setting sets the type of humidification system (heated
expiratory tube, non-heated expiratory tube, or heat-moisture exchanger -HME) used on the ventilator and can be changed during normal ventilation or
short self test (SST). Changes in humidification type phase in at the start of
inspiration.
SST calibrates spirometry partly based on the humidification type. Changing
the humidification type without rerunning SST can affect the accuracy of spirometry and delivery.
The accuracy of the exhalation valve flow sensor varies depending on the water
vapor content of the expiratory gas, which depends on the type of humidification system in use. Because the temperature and humidity of gas entering the
expiratory filter differ based on the humidification type being used, spirometry
calculations also differ according to humidification type. For optimum accuracy, rerun SST to change the humidification type.
10.15.31 Humidifier
Volume
Safety Net
While the ventilator is designed to be as safe and as reliable as possible, Covidien recognizes the potential for problems to arise during mechanical ventilation, either due to user error, patient-ventilator interactions, or because of
problems with the ventilator itself. Safety Net is a broad term that includes
strategies for handling problems that arise in the patient-ventilator system
(patient problems) as well as strategies to minimize the impact of system faults
on patient safety. In these scenarios, The ventilator is designed to alarm and to
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Theory of Operations
User Error
The ventilator is designed to prevent the operator from implementing settings
that are clearly inappropriate for the patient's predicted body weight (PBW).
Each setting has either soft bounds (can be overridden) or hard bounds (no
override allowed) that alert the operator to the fact that the settings may be
inappropriate for the patient. In the event that the patient is connected
without any parameters being specified, the ventilator enters Safety PCV, a
safe mode of ventilation regardless of the circuit type in use (neonatal, pediatric, or adult) or patient's PBW. Safety PCV is entered after POST, if a patient
connection is made prior to settings confirmation. Safety PCV uses New Patient
default settings with exceptions shown in the following table:
Table10-9.Safety PCV Settings
Parameter
PBW
Neonatal: 3 kg
Pediatric:15 kg
Adult: 50 kg
mode
A/C
mandatory type
PC
Neonatal: 25 1/min
Pediatric: 16 1/min
Adult: 16 1/min
TI
Neonatal: 0.3 s
Pediatric: 0.7 s
Adult: 1 s
PI
15 cmH2O
O2%
10-72
Neonatal: 40%
Pediatric: 100%
Adult: 100%
Operators Manual
10.16.2
3 cmH2O
Neonatal: V-TRIG
Pediatric: P-TRIG
Adult: P-TRIG
PSENS
2 cmH2O
VSENS
1.0 L/min
1PPEAK
20 cmH2O
OFF
0.05 L/min
1VTE alarm
OFF
OFF
OFF
Circuit type
Humidification type
Humidifier volume
Note:
In Safety PCV, expiratory pauses are not allowed.
10.16.3
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Theory of Operations
interface (GUI) and several modules of the breath delivery sub-system have
redundancy that, if certain faults occur, provides for ventilatory support using
settings that do not depend on the suspect hardware. System faults include
the following:
10.16.4
Hardware faults (those that originate inside the ventilator and affect its performance)
Soft faults (faults momentarily introduced into the ventilator that interfere with
normal operation
Ventilation Assurance is a safety net feature invoked if the Background Diagnostics detect a problem with certain components in either the gas mix subsystem, the inspiratory subsystem, or the expiratory subsystem. Each subsystem
has a Backup Ventilation strategy that allows ventilation to continue by bypassing the suspect components giving the operator time to replace the ventilator.
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Mix BUV is invoked if the measured gas mix is significantly different from the
set mix, if the accumulator pressure is out of range or if a fault is indicated in
the mix PSOLs or flow sensors. During MIX BUV, the normal mix controller is
bypassed and ventilation continues as set, except that the gas mix reverts to
100% Oxygen or Air, depending on where the fault indication was detected.
Backup circuits then control the pressure in the accumulator to keep it in the
proper range for the Inspiratory Module.
Inspiratory BUV is invoked if Background Diagnostics detect a problem in the
inspiratory module (PSOL and/or flow sensor signal out of range). In inspiratory
BUV, ventilation continues with the following settings:
Table10-10.Inspiratory Backup Ventilation Settings
Backup Ventilation parameter
Setting
PBW
Mode
A/C
Mandatory type
PC
Neonatal: 25 1/min
Pediatric: 16 1/min
Adult: 16 1/min
TI
Neonatal: 0.3 s
Pediatric: 0.7 s
Adult: 1 s
PI
O2%
PEEP
3 cmH2O
TPL
0s
Trigger type
Gas flow
During inspiratory BUV, the delivery PSOL is disabled, but gas delivery is
achieved via an inspiratory BUV solenoid valve, the gas flow being created by
pressure in the mix accumulator.
Exhalation BUV is invoked if problems with the Exhalation Valve driver are
detected. A backup analog circuit is enabled to control the exhalation valve
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Theory of Operations
though the more advanced control features (active exhalation valve control)
are not functional.
Note:
During Mix and Inspiratory BUV, gas supply to installed options is disabled.
Entry into BUV is logged in the alarm log and system diagnostic log, and the
status display provides an indicator that the ventilator is in BUV and which subsystem is affected.
When in BUV, a high priority alarm is annunciated, and the GUI displays an
alarm banner indicating BUV, blanks patient data, and a displays a pressure
waveform.
If the ventilator cannot provide any degree of reliable ventilatory support and
fault monitoring, then the ventilator alarms and enters the safety valve open
(SVO) emergency state. During SVO, the ventilator de-energizes the safety,
expiratory, and inspiratory valves, annunciates a high-priority alarm, and turns
on the SVO indicator. During SVO, a patient can spontaneously inspire room
air (if able to do so) and exhale. Check valves on the inspiratory and expiratory
sides minimize rebreathing of exhaled gas during SVO. During SVO the ventilator
Visible indicators on the ventilator's GUI and status display illuminate when the
ventilator is in the SVO state. Other safeguards built into the ventilator include
a one-way valve (check valve) in the inspiratory pneumatic circuit allowing the
patient to inhale through the safety valve with limited resistance. This check
valve also limits exhaled flow from entering the inspiratory limb to reduce the
possibility of re-breathing exhaled CO2 gas.
10.17
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Operators Manual
If POST detects a major fault, qualified service personnel must correct the
problem and successfully pass EST. Reference the Puritan Bennett 980 Series
Ventilator Service Manual for more details on POST.
10.18
10.19
SST is a short (about 5 minutes) and simple sequence of tests that verifies
proper operation of breath delivery hardware (including pressure and flow
sensors), checks the patient circuit (including tubing, humidification device,
and filters) for leaks, and measures the circuit compliance and resistance.
SST also checks the resistance of the expiratory filter. SST, in normal mode,
can only be performed at start up, prior to initiation of ventilation. Covidien
recommends running SST every 15 days, between patients, and when
changing the patient circuit or its configuration (including changing circuit
type, adding or removing in-line water traps, or using a different type or
style of patient circuit). Reference To run SST, p. 3-48. The ventilator does not
allow access to SST if it senses a patient is connected.
WARNING:
Do not enter Service mode with a patient attached to the ventilator. Serious
injury could result.
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Theory of Operations
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Operators Manual
11 Specifications
11.1Overview
This chapter contains the following specifications for the Puritan Bennett
980 Series Ventilator:
Physical
Electrical
Interface
Environmental
Performance (Ranges, resolution, and accuracies for ventilator settings, alarm settings, and patient data)
Regulatory Compliance
WARNING:
Due to excessive restriction of the Air Liquide, SIS, and Drger hose
assemblies, reduced ventilator performance levels may result when oxygen
or air supply pressures < 50 psi (345 kPa) are employed.
11.2Measurement Uncertainty
Table11-1.Performance Verification Equipment Uncertainty
Measured Parameter
Offset
Gain
Flow
0.1001 SLPM
2.7642 % reading
Pressure
0.121594 cmH2O
0.195756 % reading
Oxygen Concentration
0.0168 % O2
0.0973 % reading
Temperature
0.886041 C
0.128726 % reading
Atmospheric Pressure
1.76 cmH2O
Specifications
During breath delivery performance verification for flow and pressure based
measurements, the equipment inaccuracy is subtracted from the acceptance
specification as follows:
For derived parameters, such as volume, compliance, etc., the individual sensor
uncertainties are combined and applied as applicable to determine the acceptance limits.
11.3Physical Characteristics
Table11-2.Physical Characteristics
Weight
113 lb (51.26 kg) including BDU, GUI, standard base, and primary
battery
BDU only: 69 lb (31.3 kg)
Dimensions
Connectors
Hectopascal (hPa)
centimeters of water (cmH2O)
Operator's Manual
Physical Characteristics
Table11-3.Pneumatic Specifications
Oxygen and air inlet supplies
Table11-4.Technical Specifications
Maximum limited pressure (PLIMmax)
Measuring devices
Pressure measurements:
Type: Solid stated differential pressure transducer
Sensing position: Inspiratory module; expiratory
module
Mean circuit pressure (PMEAN): -20 cmH2O (-20
hPa) to 130 cmH2O (127 hPa)
Peak circuit pressure (PPEAK): -20 cmH2O (-20
hPa) to 130 cmH2O (127 hPa)
Volume Measurements:
Type: Hot film anemometer
Sensing position: Inspiratory module; expiratory
module
Oxygen measurement:
Type: Galvanic cell
Sensing position: Inspiratory module
Up to 75 L/min
Results of ventilator testing using circuits identified for use with the ventilator system
Operator's Manual
Specifications
> 99.999%
> 99.999%
> 99.999%
> 99.999%
Operator's Manual
Physical Characteristics
> 99.999%
> 99.999%
Circuit compliance
Operator's Manual
Specifications
11.4Electrical Specifications
Table11-5.Electrical Specifications
Electrical ratings
CB1: 4A
300 A
Touch current
100 A
100 A maximum
11.5Interface Requirements
Table11-6.Interface Pin Designations
Pin
Signal
Name
N/C
Not connected
RxD
Receive data
TxD
Transmit data
N/C
Not connected
GND
Ground
N/C
Not connected
RTS
Request to send
CTS
Clear to send
N/C
Mot connected
Operator's Manual
Environmental Specifications
Configuration
Relay common
Not connected
11.6Environmental Specifications
Table11-8.Environmental Specifications
Specification
Operation
Storage
Temperature
10 to 95% non-condensing
Atmospheric Pressure
Altitude
Relative Humidity
Note:
The limits marked on the device label represent out-of-box storage conditions as
follows:
Operator's Manual
Specifications
11.7Performance Specifications
11.7.1Ranges and Resolutions
Reference the table below for ranges, resolutions, accuracies, new patient
default values, and dependencies, where applicable, for ventilator settings.
Reference Alarm Settings Range and Resolution, p. 11-17 for alarm settings,
and Reference Patient Data Range and Resolution, p. 11-19 for displayed
patient data parameters.
Table11-9.Ventilator Settings Range and Resolution
Setting
Description
Apnea ventilation
Range:0.20 s to 59.8 s
Resolution: 0.01 s
Range: 0.20 s to 8 s
Resolution: 0.01 s in PC or VC+,
0.02 s in VC
Operator's Manual
Performance Specifications
Operator's Manual
Description
Apnea O2 %
Range:
NEONATAL: 3 mL to 315 mL
PEDIATRIC/ADULT: 25 mL to
2500 mL
Resolution: 0.1 mL < 5 mL; 1 mL for
5 mL to 100 mL; 5 mL for100 mL to
395 mL; 10 mL for values 400 mL
Range: TI
Range: PC, VC
Circuit type
Specifications
10
Description
Disconnect sensitivity
(DSENS)
The percentage of
returned volume lost,
above which the ventilator
declares a circuit disconnect alarm when Leak
Sync is not enabled or
installed.
Expiratory sensitivity
(ESENS)
Range: 1% to 80%
1 L/min to 10 L/min when Spontaneous Type is PAV+.
Range: 0.20 s
Resolution: 0.01 s
Flow pattern
Operator's Manual
Performance Specifications
Operator's Manual
Description
Range:
NEONATAL: 0.1 L/min to 10 L/min
PEDIATRIC/ADULT: 0.2 L/min to
20.0 L/min
Resolution: 0.1 L/min
Gender
Height
Range:
NEONATAL: 0.2 s to 1.7 s
PEDIATRIC/ADULT: 0.4 s to 5 s
Humidification type
Humidifier volume
Elevate O2%
The percentage of O2 to
be added to the current
air/O2 mixture for two
minutes
Range: 1% to 100%
Resolution: 1% between 1% and
10; 5% between 5% and 75%;
jumps to 100% when increased
above 75%
I:E ratio
11
Specifications
12
Description
Mandatory type
mL/kg ratio
Operator's Manual
Performance Specifications
Operator's Manual
Description
Mode
O2% (delivered)
Percentage of delivered
oxygen in the gas mixture
PEEP
13
Specifications
14
Description
PH
PL
Range: 0s to 2 s
Resolution: 0.1 s
Range:
NEONATAL: 0.3kg (0.66 lb) to 7.0
kg (15 lb) when NeoMode 2.0 option
is installed;
PEDIATRIC: 3.5 kg (7.7 lb) to 35 kg
(77 lb)
ADULT: 25 kg (55.12 lb)
Resolution: 0.01 kg for weights < 1
kg, 0.1 kg for weights 1 kg and <
10 kg, 1 kg for weights 10 kg
Range:
NEONATAL: 1.0 1/min to 150 1/min
PEDIATRIC/ADULT:
Resolution: 0.1 from 1.0 1/min to
9.9 1/min; 1 1/min from 10 1/min to
150 1/min
Operator's Manual
Performance Specifications
Operator's Manual
Description
Rise time %
Range: 1% to 100%
Resolution: 1%
Spontaneous type
% Supp
In Tube Compensation,
specifies the additional
positive pressure desired
to overcome resistance of
the artificial airway.
Range:10% to 100%
Resolution: 5%
% Supp
Range: 5% to 95%
Resolution: 5%
TH (time high)
Range: 0.2 s to 30 s
Resolution: 0.01 s
TL (time low)
Range: 0.20 s
Resolution: 0.01 s
TH:TL ratio
15
Specifications
16
Description
Range:
NEONATAL: 2 mL to 315 mL
PEDIATRIC: 25 mL to 1590 mL
ADULT: 25 mL to 2500 mL
Resolution: 0.1 mL < 5 mL; 1 mL for
5 mL and < 100 mL; 5 mL for 100
mL to 395 mL; 10 mL for values
400 mL
Range:
NEONATAL: 2 mL to 310 mL
PEDIATRIC: 25 mL to 1590 mL
ADULT: 25 mL to 2500 mL
Resolution: 0.1 mL for 5 mL; 1 mL
for 5 mL to < 100 mL; 5 mL for 100
mL to < 400 mL; 10 mL 400 mL
Trigger type
Range:
NEONATAL: V-TRIG
PEDIATRIC/ADULT: V-TRIG, P-TRIG or
IE Sync in SPONT (if IE Sync option
installed)
Tube ID
Tube type
Ventilation type
Invasive or non-invasive
(NIV) ventilation type
based upon the type of
breathing interface used.
Invasive: ET or Trach tubes
NIV: masks, infant nasal
prongs, or uncuffed ET
tubes
Operator's Manual
Performance Specifications
Alarm volume
Range: 1 (minimum) to 10
(maximum)
Resolution: 1
Range: 10 s to 60 s or OFF in
CPAP
Resolution: 1 s
Range:
NIV: OFF or 0.5 cmH2O to
<100 cmH2O
Resolution: 0.5 cmH2O for
values < 20.0 cmH2O;
1 cmH2O for values 20
cmH2O
(4PPEAK)
Operator's Manual
Description
17
Specifications
18
Description
Range: 6 mL to 6000 mL
Resolution: 1 mL for values <
100 mL; 5 mL for values 100
mL to < 400 mL; 10 mL for
values 400 mL
Range: OFF or
NEONATAL: 10 1/min to 170
1/min
PEDIATRIC/ADULT: 10 1/min
to 110 1/min
Resolution: 1 1/min
Range:
NEONATAL: 0.2 s to the
value of the NIV inspiratory
time limit trigger for the
patients PBW and circuit type
s
PEDIATRIC/ADULT: 0.4 s to
the value of the NIV inspiratory
time limit trigger for the
patients PBW and circuit type
s
Resolution: 0.1 s
The 3VTE MAND alarm indicates the measured mandatory tidal volume the set
alarm limit.
Operator's Manual
Performance Specifications
Description
The 3VTE SPONT alarm indicates the measured spontaneous tidal volume the set
alarm limit.
Operator's Manual
Description
Breath phase
Range: 0 mL to 6000 mL
Resolution: 0.1 mL for values
< 10 mL; 1 mL for values 10 mL
to 6000 mL
Range: 0 mL to 6000 mL
Resolution: 0.01 mL for 0 mL
to 9.9 mL, 1 mL for values 10
mL to 6000 mL
Range: 0 mL to 6000 mL
Resolution: 1 mL for values <
10 mL; 1 mL for values 10 mL
to 6000 mL
19
Specifications
20
Description
Range: 0 mL to 6000 mL
Resolution: 0.1 mL for 0 mL to
9.9 mL; 1 mL for 10 mL to 6000
mL
Operator's Manual
Performance Specifications
Operator's Manual
Description
Range: 0 mL to 6000 mL
Resolution: 0.1mL for 0 mL to
9.9 mL; 1 mL for 10 mL to 6000
mL
Range: 0 mL to 6000 mL
Resolution: 0.1mL for 0 mL to
9.9 mL; 1 mL for 10 mL to 6000
mL
Range: 0 mL to 6000 mL
Resolution: 0.1mL for 0 mL to
9.9 mL; 1 mL for 10 mL to 6000
mL
I:E ratio
Inspiratory compliance
(C20/C)
Range: 0 to 1.00
Resolution: 0.01
21
Specifications
22
Data Value
Description
O2% (monitored)
Range: 0% to 103%
Resolution: 1%
P0.1
Operator's Manual
Performance Specifications
Operator's Manual
Description
23
Specifications
24
Data Value
Description
Range: 0 mL to 500 mL
Resolution: 0.1mL for values 0
mL to 9.9 mL; 1 mL for values
10 mL to 500 mL
Range: 0 mL to 500 mL
Resolution: 1 mL
Range: 0 s to 10 s
Resolution: 0.01 s
Operator's Manual
Performance Specifications
Operator's Manual
Data Value
Description
Range: 0 to 1
Resolution: 0.01
Resistance (RSTAT)
Range: 0 mL to 6000 mL
Resolution: 0.1 mL for values
< 10 mL; 1 mL for values 10
mL
VLEAK
Range: 0 to 9000 mL
Resolution: 1 mL
25
Specifications
Description
%LEAK
Range: 0 to 100%
Resolution: 1%
LEAK
LEAKY
1. If the estimated value of CPAV, EPAV, RPAV, or RTOT violates expected (PBW-based) limits, parentheses around the value indicate
the value is questionable. If the estimated value exceeds its absolute limit, the limit value flashes in parentheses.
Table11-12.Delivery Accuracy
Parameter
26
Accuracy
Range
5 cmH2O to 90 cmH2O
0 cmH2O to 45 cmH2O
0 cmH2O to 70 cmH2O
O2% (delivered)
3%
21% to 100%
PH
5 cmH2O to 90 cmH2O
Operator's Manual
Performance Specifications
Accuracy
PL
Range
0 cmH2O to 45cmH2O
Operator's Manual
Accuracy
Range
(2 + 4% of reading) cmH2O
5 cmH2O to 90 cmH2O
(2 + 4% of reading) cmH2O
3 cmH2O to 70 cmH2O
(2 + 4% of reading) cmH2O
0 cmH2O to 45cmH2O
(2 + 4% of reading) cmH2O
5 cmH2O to 90 cmH2O
(4 mL + 15% of actual) mL
2 mL to 2500 mL
(4 mL + 10% of actual) mL
2 mL to 2500 mL
27
Specifications
Accuracy
Range
(1 + 10% of reading) mL
2 mL to 310 mL
(1 + 10% of reading) mL
2 mL to 310 mL
O2% (monitored)
3%
15% to 100%
0.8 1/min
Accuracy
Range
10 mL to 100 mL/cmH2O
PAV-based work of
breathing (WOBTOT)
WARNING:
The ventilator accuracies listed in this chapter are applicable under the
operating conditions identified in the table Environmental Specifications on
Reference p. 11-7 .
11.8Regulatory Compliance
The ventilator complies with the following standards:
28
Operator's Manual
Regulatory Compliance
IEC 60601-1-8: 2006, Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance, Collateral Standard: General
requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
EN 60601-1-8:2007, Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance, Collateral Standard: General
requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
IEC 60601-2-12:2001, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance, Collateral standard: Safety
requirements for medical electrical systems
EN 60601-2-12:2005, Medical electrical equipment Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators
ISO 80601-2-55: 2011 and EN ISO 80601-2-55: 2012, Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors - First Edition
IEC 60601-1-4:2000, Medical Electrical Equipment - Part 1-4: General Requirements for Safety - Collateral Standard: Programmable Electrical Medical Systems
IEC 60601-1-6:2010, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability
IEC/EN 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
ISO 14971:2007/EN ISO 14971:2012, Medical devices - Application of risk management to medical devices
Operator's Manual
29
Specifications
11.9Manufacturers Declaration
The following tables contain the manufacturers declarations for the ventilator
system electromagnetic emissions, electromagnetic immunity, separation distances between ventilator and portable and mobile RF communications equipment and a list of compliant cables.
WARNING:
Portable and mobile RF communications equipment can affect the
performance of the ventilator system. Install and use this device according to
the information contained in this manual.
WARNING:
The ventilator system should not be used adjacent to or stacked with other
equipment, except as may be specified elsewhere in this manual. If adjacent
or stacked used is necessary, the ventilator system should be observed to
verify normal operation in the configurations in which it will be used.
Caution:
This equipment is not intended for use in residential environments and may
not provide adequate protection to radio communication services in such
environments.
Table11-15.Electromagnetic Emissions
The ventilator is intended for use in the electromagnetic environment specified below. The customer or the operator of the ventilator should assure that it is used in such an environment.
Emissions Test
30
Compliance
Radiated RF emissions
CISPR 11
Group 1
Class A
Class A
Voltage fluctuations/flicker
IEC 61000-3-3
Complies
Operator's Manual
Manufacturers Declaration
Table11-16.Electromagnetic Immunity
The ventilator is intended for use in the electromagnetic environment specified below. The
customer or the operator of the ventilator should assure that it is used in such an environment.
Immunity Test
Compliance level
Electromagnetic
environment guidance
Electrostatic discharge
(ESD) IEC 61000-4-2
6 kV contact
8 kV air
6 kV contact
8 kV air
Floors should be
wood, concrete, or
ceramic tile. If floors
are covered with synthetic material, the relative humidity should
be at least 30%.
2 kV for power
supply lines
1 kV for input/
output lines
2 kV for power
supply lines
1 kV for input/
output lines
1 kV line(s) to line(s)
2 kV line(s) to earth
1 kV line(s) to line(s)
2 kV line(s) to earth
< 5% UT
(> 95% dip in UT) for
0.5 cycle
40% UT(60% dip in
UT) for 5 cycles
70% UT(30% dip in
UT) for 25 cycles
< 5% UT
> 95% dip in UT for 5 s
< 5% UT
(> 95% dip in UT) for
0.5 cycle
40% UT(60% dip in
UT) for 5 cycles
70% UT(30% dip in
UT) for 25 cycles
< 5% UT
> 95% dip in UT for 5 s
Power frequency
(50/60 Hz) magnetic
field
IE/EN 61000-4-8
3 A/m
3 A/m
Operator's Manual
31
Specifications
Conducted RF IEC/EN
61000-4-6
3 Vrms
150 kHz to 80 MHz
Compliance level
1 Vrms
159 kHz to 80 MHz
Electromagnetic
environment guidance
Portable and mobile
RF communications
equipment should be
used no closer to any
part of the ventilator
system, including
cables, than the separation distance calculated from the
equation applicable to
the frequency of the
transmitter.
Recommended separation distance
d = 3.5 P
10 Vrms in ISM bands1
d = 12 P
32
Operator's Manual
Manufacturers Declaration
Radiated RF IEC/EN
61000-4-3
10 V/m
80 MHz to 2.5 GHz
Compliance level
Electromagnetic
environment guidance
10 V/m Modulation of
80% AM @ 2 Hz
80 MHz to 2.5 GHz
d = 1.2 P
d = 2.3 P
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies
NOTE 2 these guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
1. The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 to 6,795 MHz; 13.553 MHz to
13.567 MHz; 26.957 MHz; and 40.66 MHz to 40.70 MHz. The compliance levels in the ISM frequency bands between 150 kHz
and 80 MHz and in the frequency range 80 MHz to 2.5 GHz are intended to decrease the likelihood mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of
10/3 is used in calculating the separation distance for transmitters in these frequency ranges.
Operator's Manual
33
Specifications
2. The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz
are intended to decrease the likelihood mobile/portable communications equipment could cause interference if it is inadvertently
brought into patient areas. For this reason, an additional factor of 10/3 is used in calculating the separation distance for transmitters
in these frequency ranges.
3. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur
radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in
the location in which the 980 Series Ventilator is used exceeds the applicable RF compliance level above, the 980 Series Ventilator
should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such
as reorienting or relocating the ventilator.
4. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
150 kHz to 80
MHz outside of
ISM bands
150 kHz to 80
MHz inside of
ISM bands
d = 3.5 P
d = 12 P
80MHz to 800
MHz
d = 1.2 P
d = 2.3 P
0.01
0.35
1.2
0.12
0.23
0.1
1.1
3.8
0.38
0.73
3.5
12
1.2
2.3
10
11
38
3.8
7.3
100
35
120
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
34
WARNING:
The use of accessories and cables other than those specified with the
exception of parts sold by Covidien as replacements for internal components,
may result in increased emissions or decreased immunity of the ventilator
system.
Operator's Manual
Safety Tests
Table11-18.
Part number and description
Cable length
10 ft (3 m)
10 ft (3 m)
10 ft (3 m)
10 ft (3 m)
10 ft (3 m)
10 ft (3 m)
10 ft (3 m)
10 ft (3 m)
10 ft (3 m)
10 ft (3 m)
11.10Safety Tests
All safety tests should be performed by qualified Service personnel at the interval specified. Reference Service Preventive Maintenance Frequency, p. 1-2 in
the Operators Manual Addendum on Preventive Maintenance.
Operator's Manual
35
Specifications
36
Operator's Manual
A.1
Overview
This appendix describes the operation of the BiLevel 2.0 ventilation mode on
the Puritan Bennett 980 Series Ventilator.
BiLevel is a mixed mode of ventilation that combines attributes of mandatory
and spontaneous breathing, with the breath timing settings determining
which breath type is favored. In BiLevel Mode, mandatory breaths are always
pressure-controlled, and spontaneous breaths can be pressure-supported (PS)
or tube compensated (TC).
FigureA-1.Spontaneous Breathing at PL
PCIRC (cmH2O)
PH
TH
PL
TL
Spontaneous breaths
BiLevel resembles SIMV mode, except that BiLevel establishes two levels of positive airway pressure. Cycling between the two levels can be triggered by
BiLevel timing settings or by patient effort.
A-1
FigureA-2.BiLevel Mode
Pressure (y-axis)
Synchronized transitions
PL
Pressure support
PH
Time-based transitions
Spontaneous breath
The two pressure levels are called Low Pressure (PL) and High Pressure (PH). At
either pressure level, patients can breathe spontaneously, and spontaneous
breaths can be assisted with tube compensation or pressure support. BiLevel
monitors mandatory and spontaneous tidal volumes separately.
Inspiratory time and expiratory time in BiLevel become Time high (TH) and Time
low (TL), respectively. During these inspiratory and expiratory times, PH is maintained during TH and PL is maintained during TL.
A.2
Intended Use
BiLevel is intended for adult, pediatric, and neonatal patients.
A.3
A-2
Operators Manual
Technical Description
Definition
WARNING
Warnings alert users to potential serious outcomes (death, injury, or adverse
events) to the patient, user, or environment.
Caution
Cautions alert users to exercise appropriate care for safe and effective use of the
product.
Note
Notes provide additional guidelines or information.
A.4
WARNING:
The ventilator offers a variety of breath delivery options. Throughout the
patient's treatment, the clinician should carefully select the ventilation mode
and settings to use for that patient based on clinical judgment, the condition
and needs of the patient, and the benefits, limitations and characteristics of
the breath delivery options. As the patient's condition changes over time,
periodically assess the chosen modes and settings to determine whether or
not those are best for the patient's current needs.
Setting Up BiLevel
BiLevel is a ventilatory mode (along with A/C, SIMV, and SPONT).
To set up BiLevel
1.
At the ventilator setup screen, enter PBW or gender and height.
2.
Touch BiLevel. After selecting BiLevel mode, the ventilator uses the PC mandatory
breath type, which cannot be changed.
3.
4.
5.
Operators Manual
Select desired ventilator settings. The default settings for BiLevel mode appear. To
change a setting, touch its button and turn the knob to set its value. PH must
always be at least 5 cmH2O greater than PL.
A-3
Note:
The rise time % setting determines the rise time to reach target pressure for
transitions from PL to PH and for spontaneous breaths, even when pressure support
(PSUPP) = 0. Expiratory sensitivity (ESENS) applies to all spontaneous breaths.
6.
Set TL, TH, or the ratio of TH to TL. To select settings that would result in a TH:TL
ratio greater than 1:1 or 4:1, you must touch Continue to confirm after reaching
the 1:1 and 4:1 limits.
FigureA-3.BiLevel Setup Screen
A.5
7.
Touch Start.
8.
Set apnea and alarm settings by touching their respective tabs at the side of the
ventilator settings screen and changing settings appropriately.
A-4
Pressure support (PSUPP) can be used to assist spontaneous breaths at PL and PH.
PSUPP is always set relative to PL. Target pressure = PL + PSUPP.
Operators Manual
Technical Description
Spontaneous patient efforts at PH are not pressure supported unless PSUPP > (PH PL). All spontaneous breaths (whether or not they are pressure supported) are
assisted by a pressure of 1.5 cmH2O.
Pressure (y-axis)
PH
PL
During spontaneous breaths, the pressure target is calculated with respect to PL.
A.6
Operators Manual
A-5
To avoid breath stacking, the ventilator does not cycle from one pressure level
to another during the earliest stage of exhalation.
A.7
A.8
Specifications
Reference the table, Ventilator Settings Range and Resolution, in Chapter 11
of this manual for the following specifications:
A.9
TH:TL ratio
Rise time %
Technical Description
BiLevel is a mode of ventilation that alternately cycles between two operatorset pressure levels, PL and PH. The pressure durations are defined by operatorset timing variables TL and TH. Transitions between the two pressure levels, PL
and PH, are analogous to breath phase transitions in PC.
At the extreme ranges of TL and TH, BiLevel can resemble the single breath type
mode A/C - PC, or the more complex breath type mode, an inverted-like
IMV. If TH and TL assume normal values with respect to PBW (for example
A-6
Operators Manual
Technical Description
TH:TL 1:2 or 1:3), then BiLevel assumes a breathing pattern similar to, if not
qualitatively identical to A/C - PC. However, as TL begins to shorten with the
TH:TL ratio extending beyond 4:1, the breathing pattern assumes a distinctly
different shape. In the extreme, the exaggerated time at PH and abrupt release
to PLwould match the pattern patented by John Downs* and defined as APRV.
In between the A/C-PC-like pattern and the APRV-like pattern, there would be
patterns with moderately long TH and TL intervals, allowing the patient sufficient time to breathe spontaneously at both PH and PL. In these types of
breathing patterns, (but less so with APRV) BiLevel, like SIMV, can be thought
of as providing both mandatory and spontaneous breath types. In this sense,
BiLevel and SIMV are classified as mixed modes.
Direct access to any of the three breath timing parameters in BiLevel is accomplished by touching the Padlock icon associated with the TH period, TL period
or the TH:TL ratio displayed on the breath timing bar in the setup screen.
While in BiLevel mode, spontaneously triggered breaths at either pressure level
can be augmented with higher inspiratory pressures using Pressure Support
(PS) or Tube Compensation (TC) breath types.
A.9.1
Synchrony in BiLevel
Just as BiLevel attempts to synchronize spontaneous breath delivery with the
patient's inspiratory and expiratory efforts, it also attempts to synchronize the
transitions between pressure levels with the patient's breathing efforts. This
allows TH to be extended to prevent transitions to PL during the patient's spontaneous inspiration. Likewise, the TL interval may be extended to prevent a
transition to PH during the patient's spontaneous exhalation.
The trigger sensitivity setting (PSENS or VSENS) is used to synchronize the transition from PL to PH. The transition from PH down to PL is synchronized with the
patient's spontaneous expiratory effort. The BiLevel algorithm will vary the TL
and TH intervals as necessary to synchronize the transitions between PL and PH
to match the patient's breathing pattern.
The actual durations of TH and TL vary according to whether or not the patient
makes any spontaneous inspiratory efforts during those periods.
*. Downs, JB, Stock MC. Airway pressure release ventilation: A new concept in ventilatory support. Crit Care Med 1987;15:459-461
Operators Manual
A-7
To manage synchrony with the patient's breathing pattern, the BiLevel algorithm partitions the TH and TL periods into spontaneous and synchronous intervals as shown in the figure below.
FigureA-5.Spontaneous and Synchronous Intervals
Pressure (y-axis)
TL
TH
Synchronous interval
PH
Spontaneous interval
PL
A.9.2
A-8
Operators Manual
Technical Description
PCIRC (cmH2O)
Operators Manual
A-9
In APRV the operator can configure the BiLevel settings to allow direct control
of TL to assure that changes in the f setting will not inadvertently lengthen the
TL period resulting in destabilization of end-expiratory alveolar volume. With
the TL period locked, changes in set f will change the TH period to accommodate the new f setting while maintaining the set TL period.
A.9.4
A.10
Mode Changes
Changing to BiLevel mode from other modes follows the general guidelines for
mode changes:
A-10
Operators Manual
B.1
Overview
This appendix describes the operation of the Puritan Bennett 980 Series Ventilator Leak Sync option. The Leak Sync option enables the ventilator to compensate for leaks in the breathing circuit while accurately detecting the
patients effort to trigger and cycle a breath. Because Leak Sync allows the ventilator to differentiate between flow due to leaks and flow due to patient respiratory effort, it provides dynamic compensation and enhances patientventilator synchrony. Reference Chapter 4 in this manual for general parameter and operational information.
B.2
Intended Use
Leak Sync is designed to compensate for leaks in the breathing circuit during
noninvasive or invasive ventilation. Leak Sync accurately quantifies instantaneous leak rates, therefore detecting patient respiratory phase transitions correctly and may affect work of breathing. Leak Sync is intended for neonatal,
pediatric, and adult patients.
B-1
B.3
Definition
WARNING
Warnings alert users to potential serious outcomes (death, injury, or adverse
events) to the patient, user, or environment.
Caution
Cautions alert users to exercise appropriate care for safe and effective use of the
product.
Note
Notes provide additional guidelines or information.
B.4
WARNING:
The ventilator offers a variety of breath delivery options. Throughout the
patient's treatment, the clinician should carefully select the ventilation mode
and settings to use for that patient based on clinical judgment, the condition
and needs of the patient, and the benefits, limitations and characteristics of
the breath delivery options. As the patient's condition changes over time,
periodically assess the chosen modes and settings to determine whether or
not those are best for the patient's current needs.
Leak Sync
Breathing circuit leaks can cause the ventilator to erroneously detect patient
inspiratory efforts (called autotriggering) or delay exhalation in pressure support. Patient interfaces such as masks are particularly prone to significant leaks.
Inaccurately declaring inspiration or exhalation can result in patient-ventilator
dysynchrony and increased work of breathing.
Changing inspiratory or expiratory sensitivity settings can temporarily correct
the problem, but requires continued frequent clinical intervention to ensure
that sensitivity is adjusted appropriately as conditions change (for example, if
the patient moves or the circuit leak changes).
B-2
Operators Manual
Technical Discussion
Leak Sync adds flow to the breathing circuit to compensate for leaks. The
maximum Leak Sync flow applies to the maximum base flow compensation
during exhalation. During pressure-based inspirations, the total delivered flow
(leak flow plus inspiratory flow) is limited by the maximum total flow.
The following table shows the maximum leak rates at set PEEP pressure that
Leak Sync will compensate based on patient type.
TableB-2.Leak Compensation Volumes Based on Patient Type
Patient type
B.5
Neonatal
15 L/min
Pediatric
40 L/min
Adult
65 L/min
3.
Operators Manual
B-3
B.6
Note:
The default value for Leak Sync is Disabled when the circuit type is Pediatric or Adult
and the Vent Type is Invasive. Otherwise the default value for Leak Sync is Enabled.
Note:
Leak Sync is not allowed for tube compensated (TC) and Proportional Assist
Ventilation (PAV+) breath types.
B-4
The Vent Setup button on the GUI screen indicates Leak Sync is active.
A new leak or change in leak rate is typically quantified and compensated within
three breaths. Monitored patient data stabilizes within a few breaths.
Operators Manual
Technical Discussion
Select inspiratory and expiratory sensitivity settings as usual. If the ventilator autotriggers, try increasing flow sensitivity (VSENS)
Note:
The absence of the Leak Detected message does not mean there is no leak.
Note:
Leak Sync is automatically enabled when ventilating a new patient and the circuit type
is neonatal, regardless of the Vent Type. If Leak Sync is disabled, it remains disabled
when switching between INVASIVE and NIV Vent Types.
FigureB-2.GUI Screen when Leak Sync is Enabled
B.6.1
LS appears on Vent Setup button notifying the operator that Leak Sync is enabled
Operators Manual
B-5
WARNING:
When Vent Type = NIV and Leak Sync is disabled, DSENS is automatically set to
OFF.
Reference the table below for a summary of DSENS settings when Leak Sync is
enabled. Note that it is possible to set DSENS below maximum Leak Sync flow.
TableB-3.DSENS settings
B.6.2
DSENS setting
Neonatal
Range: 1 to 15 L/min
Default: 2 L/min (INVASIVE ventilation) 5 L/min (NIV)
50 L/min
Pediatric
Range: 1 to 40 L/min
Default: 20 L/min
120 L/min
Adult
Range: 1 to 65 L/min
Default: 40 L/min
200 L/min
WARNING:
With significant leaks, pressure targets may not be reached due to flow
limitations.
WARNING:
Setting DSENS higher than necessary may prevent timely detection of
inadvertent extubation.
B-6
Operators Manual
Technical Discussion
Reference the table Patient Data Range and Resolution in Chapter 11 of this
manual for information regarding the following monitored patient data
parameters:
VLEAK
% LEAK
LEAK
Displayed values for Exhaled Tidal Volume (VTE ) and Inspired Tidal Volume
(VTL) are leak-compensated, and indicate the estimated inspired or exhaled
lung volume. The accuracies for VTE and VTL also change when Leak Sync is
enabled (see Technical Discussion for more information). Graphic displays of
flow during Leak Sync indicate estimated lung flows.
Operators Manual
B-7
B.7
Technical Discussion
Managing breathing circuit leaks is important to ensure appropriate breath
triggering and cycling, ventilation adequacy, and valid patient data. Detecting
and monitoring leaks can improve treatment, reduce patient work of breathing, and provide more accurate information for clinical assessments.
Leak Sync recognizes that changing pressures lead to varying deflection of
interface materials and leak sizes. The Leak Sync leak model includes a rigid
leak orifice whose size remains constant under changing pressures, combined
with an elastic leak source whose size varies as a function of applied pressure.
This algorithm provides a more accurate estimate of instantaneous leak to
improve patient-ventilator synchrony under varying airway pressures.
Leak Sync allows the ventilator to determine the leak level and allows the operator to set the flow trigger and peak flow sensitivities to a selected threshold.
The base flow during exhalation is set to:
B.7.1
Flow triggering: 1.5 L/min + estimated leak flow at PEEP + flow sensitivity.
B.7.2
Note:
Inspired tidal volume is labeled as VTL when Leak Sync is enabled, and as VTI when
Leak Sync is disabled.
B-8
Operators Manual
Technical Discussion
For readings < 100 mL, accuracy ranges apply when the percentage of inspiratory leak volume is < 80%, where the percentage of leak volume is:
(Leak volume during inspiration/total delivered inspiratory volume) x 100
B.7.3
%LEAK Calculation
Reference Patient Data Range and Resolution, p. 11-19, % LEAK parameter,
for specifications.
B.7.4
Operators Manual
B-9
B-10
Operators Manual
C IE Sync Appendix
C.1
Overview
This appendix describes the operation of the Puritan Bennett 980 Ventilator
IE Sync option.
When a mechanically ventilated patient is capable of some degree of ventilatory effort, it is essential that the ventilator be as responsive as possible to the
patients efforts. In most modes and breath types, this is done by clinicians estimating PSENS, VSENS, and ESENS.
IE Sync is a ventilator triggering and cycling algorithm based on real-time estimation of the patients intra-pleural pressure. The algorithm processes ventilator pressure and flow measurements in a way that accounts for the variability
of respiratory parameters of the patient population. In a bench-top model simulating patients with flow limitation, incomplete exhalation or weak spontaneous efforts, IE Sync triggering has been shown to decrease the number of
missed breaths when compared to flow triggering.
C.2
Intended Use
IE Sync is intended for invasively ventilated, spontaneously breathing pediatric
and adult patients, only, and not for neonatal patients.
C.3
C-1
IE Sync Appendix
Definition
WARNING
Warnings alert users to potential serious outcomes (death, injury, or adverse events) to
the patient, user, or environment.
Caution
Cautions alert users to exercise appropriate care for safe and effective use of the
product.
Note
Notes provide additional guidelines or information.
C.4
WARNING:
The ventilator offers a variety of breath delivery options. Throughout the
patient's treatment, the clinician should carefully select the ventilation mode
and settings to use for that patient based on clinical judgment, the condition
and needs of the patient, and the benefits, limitations and characteristics of
the breath delivery options. As the patient's condition changes over time,
periodically assess the chosen modes and settings to determine whether or
not those are best for the patient's current needs.
IE Sync Description
IE Sync is a triggering and cycling algorithm based on the estimated patient
intra-pleural pressure. It is only available in SPONT mode, with the following
breath types: PAV+, PS, VS, and TC. A PBW 25 kg is recommended. IE Sync
can also be used in monitoring mode, where it does not control the patient's
breath triggering and cycling, but only indicates where in the patient's breath
cycle an inspiration and expiration would have started if IE Sync were active.
C.5
Setting Up IE Sync
To set up IE Sync
1.
At the ventilator setup screen, enter the patients gender and height or PBW.
2.
C-2
Operators Manual
Technical Description
3.
4.
5.
6.
7.
8.
Note:
If Leak Sync is currently enabled, it becomes disabled when IE Sync is selected as
the trigger type. Leak Sync cannot be selected if using IE Sync as the trigger type.
Conversely, If IE Sync is disabled, then Leak Sync becomes selectable.
A message appears on the GUI stating IE Sync Startup until the IE Sync
startup period completes. The startup period takes three (3) breaths to reach a
steady state, after which it triggers and cycles the ventilator breaths. During
the startup period, the default ventilator settings are:
PSENS 2 cmH2O
Operators Manual
C-3
IE Sync Appendix
ESENS 25% if IE Sync has not been used previously, otherwise default ESENS
setting for the currently active breath type
If IE Sync is enabled while in transition from a different trigger type, then the
trigger type, PSENS, and ESENS settings from the prior breath type shall be used
during startup instead of those stated above.
C.6
Touch Accept.
3.
4.
C-4
Operators Manual
Technical Description
FigureC-3.Monitoring Dialog
C.7
5.
Touch ON.
6.
7.
8.
Touch Close.
Note:
IE Sync-related signals are not displayed during Apnea ventilation.
Operators Manual
C-5
IE Sync Appendix
Note:
IE Sync-related signals are not displayed during Apnea ventilation.
The points at which the actual inspiration and expiration took place under pressure trigger or flow
trigger
I:E signal: The points in the breath where IE Sync would have triggered an inspiration and expiration
if not in monitoring
C-6
Note:
In the PCIRC waveform above, red indicates the current breath trigger and cycle timing,
and blue indicates where IE Sync would have triggered inspiration and exhalation, had
IE Sync been the chosen trigger type.
Operators Manual
Technical Description
C.8
Technical Description
IE Sync uses a real-time estimate,
(PSYNC), of the time-derivative of intrapleural pressure for determining breath phase transitions. PSYNC is computed
every five (5) ms based on a proprietary algorithm that uses the ventilators
pressure and flow sensor readings as its inputs. IE Sync detects the start of
inspiration when PSYNC reaches the set ISENS threshold, and detects the end of
inspiration when the PSYNC signal reaches the set ESENS threshold.
C.9
Circuit occlusion
Circuit disconnect
If there are five (5) internal resets in a 20-minute period, IE Sync will automatically become disabled, and will be set to V-TRIG with new-patient default sensitivities. Reference the table Ventilator Settings Range and Resolution in
Chapter 11 of this manual. A message displays on the GUI if IE Sync becomes
disabled due to internal resets, and the unread items icon appears on the ventilator setup dialog.
Operators Manual
C-7
IE Sync Appendix
C-4
Operators Manual
D PAV+ Appendix
D.1
Overview
This appendix describes the operation of the PAV*+ software option for the
Puritan Bennett 980 Ventilator.
Proportional Assist* Ventilation (PAV+) is designed to improve the work of
breathing of a spontaneously breathing patient by reducing the patients
increased work of breathing when pulmonary mechanics are compromised.
The PAV+ breath type differs from the pressure support (PS) breath type in the
following way:
PAV+ acts as an inspiratory amplifier; the degree of amplification is set by the
% Support setting (% Supp). PAV+ software continuously monitors the
patients instantaneous inspiratory flow and instantaneous lung volume, which
are indicators of the patients inspiratory effort. These signals, together with
ongoing estimates of the patients resistance and compliance, allow the software to instantaneously compute the necessary pressure at the patient wye to
assist the patients inspiratory muscles to the degree selected by the % Supp
setting. Higher inspiratory demand yields greater support from the ventilator.
PAV+ software reduces the risk of inadvertent entry of incompatible settings,
such as small predicted body weight (PBW) paired with a large airway.
D.2
Intended Use
PAV+ is intended for use in spontaneously breathing adult patients whose ventilator predicted body weight (PBW) setting is at least 25.0 kg (55 lb). Patients
must be intubated with either endotracheal (ET) or tracheostomy (Trach) tubes
of internal diameter (ID) 6.0 mm to 10.0 mm. Patients must have satisfactory
neural-ventilatory coupling, and stable, sustainable inspiratory drive.
*. Proportional Assist and PAV are registered trademarks of The University of Manitoba, Canada. Used under license.
D-1
PAV+ Appendix
D.3
Definition
WARNING
Warnings alert users to potential serious outcomes (death, injury, or adverse
events) to the patient, user, or environment.
Caution
Cautions alert users to exercise appropriate care for safe and effective use of the
product.
Note
Notes provide additional guidelines or information.
D-2
WARNING:
The ventilator offers a variety of breath delivery options. Throughout the
patient's treatment, the clinician should carefully select the ventilation mode
and settings to use for that patient based on clinical judgment, the condition
and needs of the patient, and the benefits, limitations and characteristics of
the breath delivery options. As the patient's condition changes over time,
periodically assess the chosen modes and settings to determine whether or
not those are best for the patient's current needs.
WARNING:
PAV+ is not an available breath type in non-invasive ventilation (NIV). Do not
use non-invasive patient interfaces such as masks, nasal prongs, uncuffed ET
tubes, etc. as leaks associated with these interfaces may result in over-assist
and patient discomfort.
WARNING:
Breathing circuit and artificial airway must be free from leaks. Leaks may
result in ventilator over-assist and patient discomfort.
Operators Manual
Ventilator Settings/Guidance
D.4
WARNING:
Ensure high and low tidal volume alarm thresholds are set appropriately
because an overestimation of lung compliance could result in an undersupport condition resulting in the delivery of smaller than optimal tidal
volumes.
PAV+
WARNING:
Ensure that there are no significant leaks in the breathing circuit or around
the artificial airway cuff. Significant leaks can affect the performance of the
PAV+ option and the accuracy of resistance (R) and elastance (E) estimates.
WARNING:
Do not use silicone breathing circuits with the PAV+ option: the elastic
behavior of a silicone circuit at the beginning of exhalation can cause
pressure-flow oscillations that result in underestimates of patient resistance.
Operators Manual
D-3
PAV+ Appendix
D-4
Operators Manual
Ventilator Settings/Guidance
D.4.1
Setting Up PAV+
To set up PAV+
1.
At the ventilator setup screen, enter the patients gender and height or the
patients PBW.
2.
3.
4.
5.
Touch the desired trigger type (P-TRIG, V-TRIG, or IE Sync (if the IE Sync option is
installed).
6.
7.
Select the tube ID. Initially, a default value is shown based on the PBW entered at
ventilator startup. If this ID is not correct for the airway in use, turn the knob to
adjust the ID setting.
Note:
If the operator selects an internal diameter that does not correspond to the PBW/
tube ID range pairs listed in the following table, touch the continue button to
override the tube ID setting. If attempts are made to choose a tube ID less than
6.0 mm or greater than 10 mm, a hard bound limit is reached, as PAV+ is not
intended for use with tubes smaller than 6.0 mm or larger than 10.0 mm. When
touching Dismiss, the setting remains at the last tube ID selected. Touch Accept
or Accept ALL to accept changes, or touch Cancel to cancel changes.
8.
Operators Manual
Note:
If Leak Sync is currently enabled, it becomes disabled when PAV+ is selected.
D-5
PAV+ Appendix
D.4.2
Note:
When the ventilator is used on the same patient previously ventilated using PAV+,
the GUI displays an attention icon and the tube type and tube ID previously used,
as a reminder to the clinician to review those settings during ventilator setup.
D-6
WARNING:
Ensure that the correct artificial airway ID size is entered. Because PAV+
amplifies flow, entering a smaller-than-actual airway ID causes the flow-
Operators Manual
Ventilator Settings/Guidance
To apply new settings for the artificial airway follow these steps
1.
Touch Vent Setup at the lower left of the GUI screen.
2.
Touch Tube Type and turn the knob to select Trach or ET to set the tube type.
3.
Touch tube ID and turn the knob to set the tube ID.
4.
Touch Accept or Accept ALL to apply the new settings, or Cancel to cancel.
D.4.3
2.
3.
For non-HME humidification types, touch Humidifier Volume, then turn the knob
to adjust the (empty) humidifier volume.
4.
WARNING:
To ensure the accuracy of PAV+ breaths and spirometry measurements, run
SST following any change to the humidification type or humidification
volume settings. Ensure that the intended circuit is used with the SST.
Operators Manual
D-7
PAV+ Appendix
D.4.4
Note:
Because of the breathing variability that PAV+ allows, the 4VTE SPONT alarm, by
default, is turned OFF to minimize nuisance alarms. To monitor adequate ventilation,
use the 3VE TOT alarm condition instead.
To adjust alarm settings
1.
Touch the Alarm tab to view the current alarm settings.
D.4.5
2.
3.
Turn the knob to adjust the value of the alarm limit. Proposed values are highlighted. You can change more than one alarm limit before applying the changes.
4.
D.4.6
% Supp
Tube type
Tube ID
Trigger type
D-8
Operators Manual
Ventilator Settings/Guidance
D.4.7
Monitored Data
Reference Patient Data Range and Resolution, in Chapter 11 of this manual for
the following monitored data associated with PAV+:
Operators Manual
PBW (kg)
RPAV (cmH2O/L/s)
CPAV (mL/cmH2O
EPAV (cmH2O/L
25
0 to 50
2.5 to 29
34 to 400
35
0 to 44
3.5 to 41
24 to 286
45
0 to 31
4.5 to 52
19 to 222
55
0 to24
5.5 to 64
16 to 182
65
0 to 20
6.4 to 75
13 to 156
75
0 to 18
7.4 to 87
11 to 135
85
0 to 17
8.4 to 98
10 to 119
95
0 to 16
9.4 to 110
9.1 to 106
105
0 to 15
10 to 121
8.3 to 100
115
0 to 15
11 to 133
7.5 to 91
125
0 to 14
12 to 144
6.9 to 83
135
0 to 14
13to 156
6.4 to 77
145
0 to 14
14 to 167
6.0 to 71
150
0 to 14
15 to 173
5.8 to 67
D-9
PAV+ Appendix
D.4.8
PAV+ Alarms
Reference Non-technical Alarm Summary in Chapter 6 of this manual for a
summary of the following alarms associated with PAV+:
D.5
1VTI
Ventilator Settings/Guidance
WARNING:
For optimal performance of PAV+, it is important to select the humidification
type, tube type, and tube size that match those in use on the patient.
D-10
Note:
PAV+ has a built-in high pressure compensation (1PCOMP) limit that is determined by
the2PPEAK setting minus 5 cmH2O or 35 cmH2O, whichever is less. If the inspiratory
pressure at the patient wye (PI wye) reaches the 1PCOMP limit, the inspiration is
truncated, and the ventilator transitions to exhalation. Reference p. D-21 for more
details regarding 1PCOMP and 1PPEAK.
Operators Manual
Ventilator Settings/Guidance
D.5.1
Specified performance
k P V dt
W = -------------------------------------- i dt
V
Flow [L/s]
Work [J/L]
D.5.2
Operators Manual
the estimated total work of breathing (in Joules/L) of the patient and ventilator during inspiration (WOBTOT)
D-11
PAV+ Appendix
a shadow trace of the estimated lung pressure, shown as a solid area superimposed on the circuit pressure waveform.
PAV-based patient data estimates, including patient resistance (RPAV), lung compliance (CPAV), and intrinsic PEEP (PEEPI PAV).
Note:
Graphic displays of lung pressure and patient work of breathing are not actual
measurements, and are derived from equations using filtered estimates of pressure
and flow.
The WOB graphic is only available when SPONT mode and the PAV+ breath
type are selected. The shadow trace can be enabled or disabled when selecting
the graphic display, or after a display is paused.
The act of pausing does not affect the WOB graphic, but does store the
shadow trace. Once paused, the operator can enable or disable the shadow
trace, then view the paused waveform again with or without the shadow
trace.
D.5.3
D-12
Operators Manual
Ventilator Settings/Guidance
Definition
Description
WOBTOT
WOBPT
WOBPT ELASTIC
WOBPT RESISTIVE
Operators Manual
D-13
PAV+ Appendix
D.5.4
Shadow trace
Technical Description
When PAV+ is selected, the ventilator acts as an inspiratory amplifier, proportionally assisting the pressure generating capability of the inspiratory muscles
(PMUS).
Pressure Gradient Equation of Motion
During spontaneous breathing, PMUS generates a pressure gradient that drives
breathing gas through the artificial airway and the patients airways and into
the elastic lung-thorax, and is described by the equation of motion:
D-14
Operators Manual
Ventilator Settings/Guidance
EQUATION 1
PMUS
VL
ELUNG-THORAX
VL
Operators Manual
D-15
PAV+ Appendix
i
i
i
i
i
P MUS = V L R airway + V L K 1 + V L K 2
K2
EPAV
K1
RPAV
PiMUS could then be estimated at every control period if ViL, Riairway, and ViL
were also known.
Valid Individual Pressure Measurements
Throughout any inspiration, the individual pressure elements that make up
PMUS can be expressed as:
EQUATION 3
FLOW
p MUS = P ARTIFICIAL
VOLUME
+ P PATIENT + P PATIENT
PMUS
PFLOWPATIENT
PFLOWARTIFI-
PVOLUMEPATIENT
CIAL AIRWAY
D-16
FLOW
AIRWAY
Operators Manual
Ventilator Settings/Guidance
Equations 2 and 3 provide the structure to explain how PAV+ operates. The
clinician enters the type and size of artificial airway in use, and the software
uses this information to estimate the resistance of the artificial airway at any
lung flow.
Applying a special pause maneuver at the end of selected inspirations provides
the information the software needs to estimate patient resistance (RPAV) and
compliance (CPAV, which is converted to elastance, EPAV). Immediately following the end of the pause event, software captures simultaneous values for
PLUNG, Pwye, and VE which yield an estimate for RTOT at the estimated flow.
All raw data are subjected to logic checks, and the estimates of RPAV and CPAV
are further subjected to physiologic checks. The estimates of RPAV and CPAV are
discarded if any of the logic or physiologic checks fail. If CPAV is rejected, RPAV
is also rejected.
Valid estimates of RPAV and CPAV are required for breath delivery, and are constantly updated by averaging new values with previous values. This averaging
process smooths data and avoids abrupt changes to breath delivery. If new
values for RPAV and CPAV are rejected, the previous values remain active until
valid new values are obtained. PAV+ software monitors the update process
and generates an escalating alarm condition if the old values do not refresh.
Maneuver Breaths and % Supp
During PAV+, maneuver breaths are randomly performed every four to ten
breaths after the last maneuver breath. A maneuver breath is a normal PAV+
inspiration with a pause at end inspiration. Because muscle activity is delayed
for at least 300 ms following the end of neural inspiration, the patients respiratory control center does not detect the pause. With this approach, maneuver
breaths are delivered randomly so that their occurrence is neither consciously
recognized nor predictable.
A PAV+ breath begins, after the recognition of a trigger signal, with flow
detection at the patient wye. The sample and control cycle of the ventilator
(the value of i in Equation 2) is frequent enough to yield essentially constant
tracking of patient inspiration. At every ith interval, the software identifies
instantaneous lung flow (ViL), which is impeded by the resistances of the artificial airway and patient airways) and integrates this flow to yield an estimate
of instantaneous lung volume, (ViL), which is impeded by the elastic recoil of
the lung and thorax).
Operators Manual
D-17
PAV+ Appendix
Using the values for instantaneous lung flow and lung volume, PAV+ software
calculates each of the pressure elements in Equation 2, which gives the value
of PMUS at each ith interval.
At this point, Equation 2 and the subsequent analysis identifies that an appropriate patient, supported by PAV+ and with an active PMUS (an absolute
requirement) will, within a few breaths, enable the algorithm to obtain reasonable estimates of RPAV and EPAV. Once these physiologic data are captured
(and over a relatively brief time as they are improved and stabilized), the PAV+
algorithm mirrors the patient's respiratory mechanics, which then allows the
ventilator to harmoniously amplify PMUS. The key point to recognize is that
patient's continuous breathing effort drives the PAV+ support no effort,
no support.
The % Supp setting specifies the amount of resistance- and elastic-based pressure to be applied at each ith interval at the patient wye.
By taking all of the above information into consideration, EQUATION 2 can be
rewritten to include the % Supp setting recognizing that ViL and ViL are driven
by the patient, not by the ventilator. (It is important to note that the ventilator
is not amplifying its own flow only the flow generated by PMUS.)
EQUATION 4
i
i
i
i
i
P wye = S V L R airway + S V L K 1 + S V L K 2
Piwye
D-18
Operators Manual
Ventilator Settings/Guidance
PiMUS
PiGRADIENT
piwye
D.5.5
Operators Manual
D-19
PAV+ Appendix
PiL recoil
EL (true)
ViL (true)
Over-inflation will not occur as long as Piwye (elastic) < PiL recoil, which is equivalent to the inequality:
S[ViL (estimated) x K2] < ViL (true) x EL(true)
where:
K2 = EPAV1
1. see equations 2 and 4
As long as EPAV (estimated) = EPAV (true) and ViL (estimated) = ViL (true) then
Pirecoil> Piwye even at high values of % Supp (i.e. between 85% and 95%).
This means that if the pressure applied to the lung-thorax is never greater than
EL (true) x VL, lung volume will collapse if wye flow vanishes. As long as EPAV
(estimated) EL (true), ViL (estimated) ViL (true), and RPAV (estimated)
RL(true), PMUS is the modulator of Piwye.
Hyperinflation could occur if the estimated EPAV were greater than the true
value of EL. At a high % Supp setting, Piwye (elastic) could exceed PiL recoil,
causing a self-generating flow at the patient wye, which in turn would cause
a self-generating inflation of the lungs. This is part of the reason that the
% Supp setting is limited to 95%.
Likewise, if the estimated RPAV were to exceed the true value of RL at a high
% Supp setting, Piwye (resistive) could exceed the value necessary to compensate for pressure dissipation across the artificial and patient airways, resulting
in early hyperinflation of the lungs. As flow declines after the first third of inspiration, however, the hyperinflating effect would most likely disappear.
D-20
Operators Manual
Ventilator Settings/Guidance
PAV+ software includes these strategies to minimize the possibility of hyperinflation of the lungs:
1.
2.
The raw data for RPAV and CPAV are checked for graph/math logic, and estimated
mechanics values are checked against PBW-based physiologic boundaries. These
checks reduce the possibility of overestimating patient resistance or underestimating patient compliance, which could lead to potential over-inflation.
3.
The high inspiratory tidal volume limit (2VTI) places an absolute limit on the integral of lung flow (including leak flow), which equals lung volume. If the value of
VTI reaches this limit, the ventilator truncates inspiration and immediately transitions to exhalation.
4.
The 2VTI setting places an upper limit on the value of the PVOLUMEPATIENT component of Piwye (see Equations 3 and 4). At the beginning of each new inspiration,
PAV+ software calculates a value for PVOLUMEPATIENT as follows:
The high inspiratory pressure limit (2PPEAK) applies to all breaths, and is used by
PAV+ software to detect the high compensation pressure condition (1PCOMP):
Operators Manual
D-21
PAV+ Appendix
Although this freezes the value of Piwye, patient activity such as coughing could
drive Piwye to 2PPEAK, causing inspiration to end.
The rapid rise of Piwye to the 1PCOMP limit would likely occur in the first third of
inspiration, and only if RPAV were overestimated and % Supp were set above
85%. The 1PCOMP condition guards against over-inflation due to overestimation
of RPAV.
6.
The % Supp setting ranges from 5 to 95% in 5% increments. Reducing the level
of support decreases the possibility of over-inflation. A significant decrease could
produce a sensation of inadequate support, and the patient would absorb the
additional work of inspiration or require an increase in the level of support.
A significant increase could cause a surge in the ventilator generated value for
Pwye, which in turn could cause Piwye to reach 2PCOMP and lead to temporary
patient-ventilator disharmony. To minimize this possibility, PAV+ software limits
the actual increase in support to increments of 10% every other breath until the
new setting is reached.
7.
Spirometry remains active during PAV+ operation. 2VTI can be set high enough to
allow spontaneous sigh breaths, while 4VE TOT and 2VE TOT remain active to reveal
changes in minute ventilation.
Because PAV+ cannot operate without valid estimates of RPAV and CPAV, and
because those values are unknown when PAV+ starts, a startup routine obtains
these values during four maneuver breaths that include an end inspiratory pause
that provides raw data for RPAV and CPAV, and both estimated values must be
valid. If either value is invalid during any of the four startup breaths, the software
schedules a substitute maneuver breath at the next breath. Reference PAV+, p.
D-3.
A low-priority alarm becomes active if a 45-second interval elapses without valid
estimates for RPAV and CPAV. If the condition persists for 90 seconds, the alarm
escalates to medium-priority. If the condition persists for 120 seconds, the alarm
escalates to high priority. The 3VE TOT and1fTOT alarms are also associated with this
condition.
Similarly, if RPAV and CPAV cannot be updated with valid values after a successful
PAV+ startup, a low-priority alarm is activated if the condition persists for 15 minutes. If the values still cannot be updated with valid values after 30 minutes, the
alarm escalates to medium priority.
D-22
Operators Manual
Ventilator Settings/Guidance
If PAV+ estimates a high lung resistance following a sharp spike in the expiratory
flow waveform, then a PBW-based resistance value is used. Reference the waveform and table below.
8.
Flow (V)
Expiration
Inspiration
Resistance
(cmH2O/L/s)
PBW
(kg)
Resistance
(cmH2O/L/s)
PBW
(kg)
Resistance
(cmH2O/L/s)
PBW (kg)
25
18.1
43
13.5
61
11.3
79
10.1
26
17.7
44
13.3
62
11.2
80
10.1
27
17.4
45
13.2
63
11.1
81 to 150
28
17.1
46
13.0
64
11.0
29
16.8
47
12.9
65
10.9
30
16.5
48
12.7
66
10.9
31
16.2
49
12.6
67
10.8
32
15.9
50
12.4
68
10.7
33
15.7
51
12.3
69
10.7
34
15.4
52
12.2
70
10.6
Operators Manual
Resistance
(cmH2O/L/s)
10
D-23
PAV+ Appendix
D-24
PBW
(kg)
Resistance
(cmH2O/L/s)
PBW
(kg)
Resistance
(cmH2O/L/s)
PBW
(kg)
Resistance
(cmH2O/L/s)
35
15.2
53
12.1
71
10.5
36
14.9
54
12.0
72
10.5
37
14.7
55
11.8
73
10.4
38
14.5
56
11.7
74
10.4
39
14.3
57
11.6
75
10.3
40
14.1
58
11.5
76
10.3
41
13.9
59
11.4
77
10.2
42
13.7
60
11.3
78
10.2
PBW (kg)
Resistance
(cmH2O/L/s)
Operators Manual
E.1
Overview
This appendix describes how to use NeoMode 2.0 software on the Puritan Bennett 980 Neonatal Ventilator. NeoMode 2.0 enables the use of the ventilator with neonatal patients and is included with all Puritan Bennett 980
Neonatal Ventilators, and Puritan Bennett 980 Universal Ventilators. In
order for a Puritan Bennett 980 Pediatric-Adult Ventilator to be used with
Neonatal patients, the NeoMode 2.0 software option must be installed.
E.2
Intended Use
NeoMode 2.0 is intended to provide respiratory support to neonatal patients
with predicted body weights as low as 0.3 kg (0.66 lb). It is intended to cover
a wide variety of clinical patient conditions in hospitals and hospital-type facilities, and may be used during intra-hospital and intra-hospital-type facility
transport. It supports delivered tidal volumes as low as two (2) mL.
E.3
E-1
Definition
WARNING
Warnings alert users to potential serious outcomes (death, injury, or adverse
events) to the patient, user, or environment.
Caution
Cautions alert users to exercise appropriate care for safe and effective use of the
product.
Note
Notes provide additional guidelines or information.
E.4
E-2
Safety Information
WARNING:
The Puritan Bennett 980 Series Ventilator contains phthalates. When used
as indicated, very limited exposure to trace amounts of phthalates may occur.
There is no clear clinical evidence that this degree of exposure increases
clinical risk. However, in order to minimize risk of phthalate exposure in
children and nursing or pregnant women, this product should only be used as
directed.
WARNING:
The ventilator offers a variety of breath delivery options. Throughout the
patient's treatment, the clinician should carefully select the ventilation mode
and settings to use for that patient based on clinical judgment, the condition
and needs of the patient, and the benefits, limitations and characteristics of
the breath delivery options. As the patient's condition changes over time,
periodically assess the chosen modes and settings to determine whether or
not those are best for the patient's current needs.
WARNING:
Neonatal patients are at risk for hypercarbia or hypoxemia during
3VE TOT alarm conditions.
Operators Manual
Ventilation Features
E.5
WARNING:
Disabling the low exhaled minute volume (3VE TOT) alarm increases the
patients risk of Hypercarbia or Hypoxemia.
WARNING:
When Using NIV, the patients exhaled tidal volume (VTE) could differ from
the ventilators monitored patient data value for VTE due to leaks around the
interface. To avoid this, ensure Leak Sync is installed. When NIV is selected,
Leak Sync is automatically enabled.
Description
The ventilator determines values for operational variables and allowable settings based on breathing circuit type and predicted body weight (PBW). The
PBW range for neonates is 0.3 kg to 7.0 kg (0.66 lb to 15 lb). Software controls
prevent inadvertent mismatching of patient size and breathing circuit type. A
neonatal breathing circuit connects to a neonatal expiratory filter which must
be used with the neonatal adapter door assembly.
E.6
Note:
To enable NeoMode 2.0, select the neonatal breathing circuit type in Short Self Test
(SST). Breathing circuit type can only be changed during SST. NeoMode 2.0 software
restricts the circuit type selection to neonatal.
Operators Manual
E-3
Note:
Reference the Inspiratory filter and expiratory filter instructions for use (IFU) for
information on filtration efficiency and filter resistance.
To install the neonatal adapter door
1.
Remove expiratory limb of patient circuit from expiratory filter.
2.
Lift expiratory filter latch. Reference Installing Neonatal Filter and Door, p. E-4.
3.
4.
3.
4.
E-4
Operators Manual
Ventilation Features
E.7
WARNING:
To ensure all breathing circuit connections are leak tight, perform a circuit
leak test by running SST every time the filter is installed. The circuit leak
test can be performed as an individual test from the SST startup screen,
but after the leak test is performed, the entire suite of SST tests must be
performed without a failure before ventilation can begin.
Empty the condensate vial before fluid reaches the maximum fill line. Condensate vial overflow can enter the filter or the breathing circuit, and can
cause increased expiratory flow resistance. Change the filter if it appears
to be saturated.
The neonatal expiratory filter and condensate vial is a single unit and is
for single-patient use, only. Do not attempt to sterilize the filter assembly.
WARNING:
Adding accessories to the ventilator can change the pressure gradient across
the ventilator breathing system (VBS) and affect ventilator performance.
Ensure any changes to the recommended ventilator circuit configurations do
not exceed the specified values for inspiratory and expiratory pressure drop.
Reference the table Technical Specifications on p. 11-3 in this manual. If
adding accessories to the patient circuit, always run SST to establish circuit
compliance and resistance prior to ventilating the patient.
Note:
If the ventilator has not reached operating temperature from recent usage, allow it to
warm up for at least 15 minutes before running SST to ensure accurate testing.
Note:
Check the inspiratory and expiratory limbs of the breathing circuit and in-line water
traps regularly for water buildup. Under certain conditions, they can fill quickly. Empty
and clean the in-line water traps as necessary. Reference the manufacturers
instructions for additional information.
Operators Manual
E-5
WARNING:
To avoid liquid entering the ventilator, empty the condensate vial before the
liquid level reaches the maximum fill line.
The condensate vial assembly is integrated with the neonatal expiratory filter
and does not contain a drain port. Empty the condensate vial when fluid
reaches the maximum fill line.
To empty the condensate vial
1.
While holding the expiratory filter, twist the condensate vial clockwise approximately one quarter turn to remove it.
E.8
2.
Remove by carefully lowering the vial all the way down to the base of the exhalation compartment and then slide the vial out.
3.
4.
Replace the condensate vial by carefully sliding the vial into position, lifting it
upward to the filter assembly, and turning counterclockwise until it reaches the
stop.
Note:
Condensate vial removal may cause the loss of system pressure and a disconnect
alarm.
Reference How to Connect the Breathing Circuit, p. E-7 to connect the breathing circuit.
E-6
Operators Manual
Ventilation Features
Humidifier
To Patient port
Inspiratory filter
Condensate vial
Operators Manual
E-7
E.9
Part number
3078447
780-06
RT235
Ventilation Features
Ventilation using NeoMode 2.0 is performed exactly as described in Chapter
4 of this manual. Reference Ventilator Operation, p. 4-7. If using a Puritan Bennett 980 Neonatal Ventilator, NeoMode 2.0 is already in use and a neonatal
patient circuit is the only choice available when performing SST. If using a
Puritan Bennett 980 Pediatric-Adult Ventilator or Puritan Bennett 980Universal Ventilator, the NeoMode 2.0 software option must be installed and SST
must be run using a neonatal patient circuit.
E.9.1
WARNING:
Always run SST prior to patient ventilation, ensuring that all accessories used
during ventilation are in the ventilator breathing system when SST is run. This
ensures correct calculation of compliance and resistance. Reference SST (Short
Self Test), p. 3-46 for more information.
E.9.2
Elevate O2
In NeoMode 2.0, the elevate O2 control works exactly as described in
Chapter 3 of this manual, except when the ventilator is in stand-by or circuit
disconnect states. If the elevate O2 function is used during these conditions,
E-8
Operators Manual
Ventilation Features
the value chosen for elevate O2 applies to the currently delivered oxygen concentration (which is 40% O2 in these cases) and not the set oxygen concentration.
E.9.3
CPAP Mode
When using NeoMode 2.0 and ventilating with non-invasive ventilation (NIV),
a separate CPAP mode allows spontaneous breathing with a desired PEEP
level. In order to limit inadvertent alarms associated with the absence of
returned volumes in nasal CPAP breathing, CPAP does not make available
exhaled minute volume and exhaled tidal volume alarm settings. Since some
neonates dont trigger breaths, the default apnea interval, TA, is set to OFF.
Also, some settings changes will initiate a PEEP restoration breath before
phasing in those changes.
Note:
In CPAP, Apnea Time, TA can be adjusted, if desired. It merely defaults to OFF to avoid
inadvertent alarms. The message APNEA DETECTION DISABLED is displayed at
the bottom of the GUI screen. The attention icons are also displayed.
To set the ventilator for CPAP
1.
Select New Patient from the ventilators startup screen or touch Vent Setup.
2.
3.
4.
Touch CPAP.
5.
Touch each ventilator setting and turn the knob to select appropriate ventilator
settings. When finished, touch Accept or Accept ALL.
6.
Complete the setup by setting the apnea parameters and alarm limits from their
respective tabs.
Operators Manual
E-9
E.9.4
E-10
2.
3.
4.
Note:
Exhaled minute volume (VE TOT), exhaled tidal volume (VTE SPONT), and inspired tidal
volume (VTI) alarms are disabled upon entry into CPAP.
Operators Manual
Ventilation Features
E.9.5
E.9.6
The VE TOT, VTE MAND, VTE SPONT, and VTI alarms are set to their respective new
patient defaults.
When transitioning from apnea interval set to OFF to an apnea interval of time
(TA), the new setting is phased in immediately.
The VE TOT, VTE MAND, VTE SPONT, and VTI alarm sliders appear in the alarm settings
screen according to their applicability to the selected mode.
Compliance Compensation
Reference Compliance Compensation in Volume-based Breaths in Chapter 10
of this manual for a complete discussion of compliance compensation. Compliance compensation in NeoMode 2.0 is implemented exactly as described in
the aforementioned reference.
E.9.7
Note:
If the patients compliance decreases beyond the limits of compliance compensation,
the ventilator relies on the 2PPEAK alarm setting to truncate the breath and switch to
exhalation.
Reference the tables for Ventilator Settings, Alarm Settings, and Patient Data
in Chapter 11 of this manual for the ranges for each ventilator setting or data
value. Most settings, however, are also limited by other settings or conditions
(for example, a low alarm limit is always limited by the corresponding high
alarm limit). Review the prompt area when making settings changes.
Operators Manual
E-11
Volume Accuracy
Volume accuracy testing in VC+ was conducted to demonstrate performance
of delivered and monitored parameters. The following tables provide a
summary of the actual results obtained within the range of two (2) mL to 25
mL collected during test execution.
The first column (Set Tidal Volume) represents the desired volume setting in
milliliters (mL). The second column represents the total number of test points
for test cases executed at that specific setting. The third column is the mean
(Mean Value) of the ventilators and test cases executed for the setting listed.
The fourth column represents the standard deviation of measurements taken
for the ventilators and test cases executed at the setting listed.
The measurements were taken using instrumentation located at the patientconnection port. Accessories such as filters and humidifiers were in the circuit
during the test. Values were BTPS and compliance compensated. A sample size
of five (5) ventilators was used to conduct the testing. Testing was conducted
at 22C 5C.
TableE-3.Delivered Volume Accuracy
Set Tidal Volume
(mL)
Number of Test
Points
Mean Value
STD
150
2.067
0.198
270
4.853
0.324
15
240
15.108
0.383
25
270
24.608
0.607
E-12
Number of Test
Points
Mean Value
STD
150
2.055
0.192
270
4.872
0.346
15
240
15.235
0.379
25
265
24.633
0.566
Operators Manual
Ventilation Features
Operators Manual
Number of Test
Points
Mean Value
STD
150
2.212
0.274
270
5.892
0.607
15
240
16.145
0.851
25
265
25.492
0.819
E-13
E-14
Operators Manual
F.1
Overview
This appendix describes the operation of the Proximal Flow Option for the
Puritan Bennett 980 Series Ventilator. The Proximal Flow Option is solely
used for monitoring flows, pressures, and tidal volumes and does not control
these parameters in any way.
The Proximal Flow Sensor is designed to measure the lower flows, pressures
and tidal volumes at the patient wye typically associated with invasively ventilated neonatal patients.
For general parameter and general ventilator setup information, reference
Chapter 4 in this manual.
F.2
Intended Use
The Proximal Flow Option is used for measuring flows, pressures, and tidal
volumes of invasively ventilated neonatal patients with predicted body weights
(PBW) of 0.3 kg (0.66 lb) to 7.0 kg (15.4 lb) using ET tube sizes from 2.5 mm
to 4.0 mm. The NeoMode 2.0 software option must also be installed on the
ventilator.
F.3
F-1
Definition
WARNING
Warnings alert users to potential serious outcomes (death, injury, or adverse
events) to the patient, user, or environment.
Caution
Cautions alert users to exercise appropriate care for safe and effective use of the
product.
Note
Notes provide additional guidelines or information.
F.4
Software/Hardware Requirements
The Proximal Flow Option requires installation of the NeoMode 2.0 software
option or a Puritan Bennett 980 Neonatal Ventilator must be used. Details
regarding NeoMode 2.0 can be found in the NeoMode 2.0 Appendix .
F.5
F-2
Safety Information
WARNING:
The Puritan Bennett 980 Series Ventilator contains phthalates. When used
as indicated, very limited exposure to trace amounts of phthalates may occur.
There is no clear clinical evidence that this degree of exposure increases
clinical risk. However, in order to minimize risk of phthalate exposure in
children and nursing or pregnant women, this product should only be used as
directed.
WARNING:
The ventilator offers a variety of breath delivery options. Throughout the
patient's treatment, the clinician should carefully select the ventilation mode
and settings to use for that patient based on clinical judgment, the condition
and needs of the patient, and the benefits, limitations and characteristics of
the breath delivery options. As the patient's condition changes over time,
periodically assess the chosen modes and settings to determine whether or
not those are best for the patient's current needs.
Operators Manual
Part numbers
WARNING:
Inspect the Proximal Flow Sensor prior to use, and do not use it if the sensor
body, tubing, or connector are damaged, occluded, or broken.
WARNING:
Do not use the Proximal Flow Sensor if there are kinks in the tubing.
WARNING:
Prior to patient ventilation with the Proximal Flow Option, run SST with the
exact configuration that will be used on the patient. This includes a neonatal
patient circuit, Proximal Flow Sensor, and all accessories used with the patient
circuit. If SST fails any Proximal Flow Sensor test, check the patient circuit and
the Proximal Flow sensor for leaks or occlusions and replace the flow sensor,
if necessary. If SST continues to fail, it may indicate a malfunction or a leak
within the Proximal Flow hardware which could compromise accuracy or
increase the likelihood of cross-contamination; thus, replace the Proximal
Flow hardware.
WARNING:
Changing ventilator accessories can change the system resistance and
compliance. Do not add or remove accessories after running SST.
WARNING:
If the Proximal Flow Option fails to respond as described in this appendix,
discontinue use until correct operation is verified by qualified personnel.
WARNING:
The Proximal Flow Sensor measures gas flow at the patient wye. The actual
volume of gas delivered to the patient may be affected by system leaks
between the patient and the Proximal Flow Sensor, such as a leak that could
occur from the use of an uncuffed endotracheal tube.
WARNING:
Position the Proximal Flow Sensor exactly as described in this appendix or the
Instructions for Use (IFU) provided with the sensor.
Operators Manual
F-3
F-4
WARNING:
Do not position the Proximal Flow Sensor cables or tubing in any manner that
may cause entanglement, strangulation or extubation which could lead to
hypercarbia or hypoxemia. Use the cable management clips supplied to
mitigate this risk.
WARNING:
To reduce the risk of extubation or disconnection, do not apply tension to or
rotate the Proximal Flow Sensor by pulling on the Proximal Flow Sensors
tubing.
WARNING:
Do not install the Proximal Flow Sensor in the patient circuit if the sensor is
not also connected to the BDU.
WARNING:
Excessive moisture in the Proximal Flow Sensor tubing may affect the
accuracy of the measurements. Periodically check the sensor and tubing for
excessive moisture or secretion build-up.
WARNING:
The Proximal Flow Sensor is intended for single use only. Do not re-use the
sensor. Attempts to clean or sterilize the sensor may result in
bioincompatibility, infection, or product failure risks to the patient.
WARNING:
Install the Proximal Flow Sensor as shown. Reference Attaching Proximal
Flow Sensor, p. F-14. Improper orientation of the flow sensor could lead to
misinterpretation of data or incorrect ventilator settings.
Caution:
Do not use aerosolized medications with the Proximal Flow Sensor. Such
medications may damage the sensor.
Caution:
To prevent damage to pneumatic lines, use supplied cable management clips.
Operators Manual
Part numbers
F.6
Caution:
Use only Covidien-branded Proximal Flow Sensors with the Proximal Flow
Option.
F.6.1
Operators Manual
F-5
F.7
On-screen symbols
When using the Proximal Flow Option, flow, pressure, and volume waveform
data, along with delivered and exhaled volumes are derived from Proximal
Flow Sensor measurements at the patient circuit wye. Proximal flow data are
displayed on the waveform plot with a Y appearing in inverse video next to the
measurement symbol.
F-6
Operators Manual
Part numbers
Inspired and exhaled flows and volumes at the patient wye are measured and
identified by the symbols shown below, and correspond to their non-proximal
flow equivalents. These values appear in the patient data panel if so configured. Reference Vital Patient Data on page 3-42, and the figure above.
Operators Manual
F-7
VTEY
VTE SPONTY
VTE MANDY
VE TOTY
VY
VTLY
Description
Note:
In the patient data symbols shown above, the Y appears in inverse video, as shown.
Reference Sample GUI screen Showing Proximal Flow Data, p. F-7.
Note:
When the Proximal Flow and Leak Sync options are enabled, the following parameters
are available for display:
When only the Proximal Flow option is enabled, VTIY and VTI are available for display
When a Y appears in the symbol, the data are measured with the proximal flow
sensor. When a Y is absent from the symbol, the data are measured by the
ventilators internal flow sensors.
F.8
F-8
Operators Manual
Part numbers
The purge function is designed to clear the pneumatic lines of fluids that may
collect, and is performed periodically by sending a brief flow of air through the
sensor lines. Autozero and purge functions are only active during exhalation
which limits the effect of the purge gas on delivered oxygen concentration.
During the autozero or automatic purge processes, the measurement and
display of proximal flow data is not shown in real time and a brief message
appears on the GUI indicating the purge process is occurring.
During autozero or automatic purge processes, the pressure waveforms, when
shown display the current PEEP value and the flow waveform, when shown,
displays a value of 0.
FigureF-3.Message During Autozero and Purge Processes
F.9
SST Requirements
SST must be run prior to ventilation and all circuit components and accessories
must be installed in the configuration to be used on the patient in order for the
ventilator to calculate the correct compliance and resistance. This includes a
neonatal patient circuit, Proximal Flow Sensor, and other accessories used
during ventilation. Reference To run SST in Chapter 3 of this manual. There is
also a table listing the general SST test sequence located in that section. Ref-
Operators Manual
F-9
erence the table below for a listing of the test sequence when running SST
with the Proximal Flow Option.
Note:
Failure of the Proximal Flow Option to pass SST does not prevent ventilation, but will
prevent measurement with the Proximal Flow Option. The ventilator will use its
internal flow sensors for measurement instead of the Proximal Flow Option.
TableF-3.Proximal Flow Option SST test Sequence
Test Step
F-10
Function
Comments
N/A
SST EV Performance
N/A
N/A
SST Leak
N/A
Checks for inspiratory and expiratory limb occlusions, and calculates and stores the
inspiratory and expiratory limb
resistance parameters.
N/A
N/A
SST Prox
Operators Manual
Part numbers
F.9.1
2.
3.
4.
When prompted to attach the Proximal Flow Sensor, unblock the circuit wye and
insert the smaller end of the sensor into the wye.
5.
When prompted, cap or seal the larger end of the sensor (marked with UP and
an arrow).
6.
Operators Manual
F-11
If SST fails, check the patient circuit and flow sensor connections for leaks or
occlusions and replace the Proximal Flow Sensor, if necessary. Replace the
Proximal Flow Option hardware if SST continues to fail, then repeat SST to
determine circuit compliance and resistance. Reference the Puritan Bennett
980 Series Ventilator Hardware Options Installation Instructions, p/n
10084704 for instructions on replacing the Proximal Flow Option hardware.
F.10
F-12
2.
Touch the Options tab. A screen appears containing the Installed Options and Prox
tabs.
3.
Operators Manual
Part numbers
F.11
Note:
If the Proximal Flow Option has been disabled or enabled, SST does not have to be rerun unless the breathing circuit or other breathing system accessories have been
changed, removed, or added.
Operators Manual
Open the connector panel door and firmly attach the sensor connector to the
right-most receptacle in the BDUs front connector port labeled Prox. Reference
Attaching Proximal Flow Sensor to Ventilator, p. F-11.
F-13
To attach the Proximal flow sensor between the endotracheal tube and
patient circuit
1.
Connect the larger end of the sensor (marked with UP and an arrow) to the
endotracheal tube. Reference the figure below. Do not force the connection;
when the sensor is oriented correctly, insertion requires little effort.
Note:
If using a Heat-Moisture Exchanger (HME) on the endotracheal tube, place the
Proximal Flow Sensor between the HME and the breathing circuit wye.
FigureF-6.Attaching Proximal Flow Sensor
F-14
Endotracheal tube
2.
Connect the smaller end of the sensor to the breathing circuit wye.
3.
Grasp the sensors plastic body with one hand and the breathing circuit wye
with the other hand.
b.
Rotate the sensor body and wye towards each other until the sensor tubing is
upright.
c.
Confirm a tight connection between the sensor and breathing circuit wye.
Operators Manual
Part numbers
4.
F.11.1
Use the three cable management clips provided with the sensor to attach the
sensor tubing to the breathing circuit tubing. Space the clips evenly along the
length of the sensor tubing. Twist the ends of each clip to close.
Note:
When the ventilator is set up for Proximal Flow Option operation, the Proximal
Flow Sensor can be switched as necessary. There is no need to run SST after
switching sensors unless the breathing circuit or other ventilator accessories have
been changed.
Touch the Options tab. A screen appears containing the Installed Options and Prox
tabs.
3.
4.
Touch Start that appears next to the text Prox Manual Purge: To begin touch the
Start button. During the purge, a message appears in the GUI prompt area
stating the purge process is being performed.Reference Message During Autozero
and Purge Processes, p. F-9.
Operators Manual
F-15
FigureF-7.Manual Purge
F.12
Alarms
If the Proximal Flow Option becomes inoperable during ventilation, the ventilator annunciates an alarm and flow sensing reverts to the ventilators internal
delivery and exhalation valve flow sensors. This switch over may be triggered
by any of the following events:
There is a communication failure between the ventilator and the Proximal Flow
option
If any of these conditions occur, the GUI displays an alarm message similar the
one shown below.Follow the information contained in the remedy message to
troubleshoot the alarm.
F-16
Operators Manual
Part numbers
F.13
F.13.1
Accuracy1
1. The conditions under which the accuracy values apply are as follows:
Sensor is used as described in this appendix and/or the Instructions for Use provided with the sensor
Operators Manual
F-17
F.14
Parameter
Specification
Weight
6.6 g
Dead space
< 1 mL
Pressure drop
Part Numbers
The table below lists the part numbers for the Proximal Flow Option Kit and
individual components.
TableF-6.Proximal Flow Option Component Part Numbers
Item
Part Number
10084331
Includes:
Installation hardware and accessories
F-18
10047078
10087622
Interconnect PCBA
10083941
10083940
10083966
10083963
10005748
Operators Manual
Glossary
A message displayed on the GUI screen during an alarm condition, identifying the root cause of the alarm.
assist breath
A ventilation mode where only mandatory VC, PC, or VC+ breaths are
delivered to the patient.
augmented alarm
The initial cause of an alarm has precipitated one or more related alarms.
When an alarm occurs, any subsequent alarm related to the cause of this
initial alarm augments the initial alarm.
autotriggering
The ventilator delivers repeated, unintended breaths triggered by fluctuating flows or pressures as opposed to patient demand. Patient circuit
leaks and low flow or pressure sensitivity settings are common causes of
autotriggering.
background checks
backup ventilation
(BUV)
A safety net feature which is invoked if a system fault in the mix subsystem, inspiratory subsystem, or expiratory subsystem occurs compromising the ventilators ability to ventilate the patient as set.
base flow
A constant flow of gas through the patient circuit during the latter part
of exhalation during flow triggering (V-TRIG). The value of this base flow
is 1.5 L/min greater than the operator selected value for flow sensitivity.
base message
batch changes
The system for supplying battery back-up power to a device. The ventilator's battery back-up system consists of a single primary battery to
provide up to one (1) hour of battery power to the ventilator. An optional
extended battery with the same characteristics as the primary battery is
available.
BD, BDU
Glossary-1
Glossary-2
BiLevel mode
BOC
British Oxygen Company. A standard for high pressure gas inlet fittings.
breath stacking
BTPS
cmH2O
compliance volume
The volume of gas that remains in the patient circuit and does not enter
the patient's respiratory system.
One of three breath timing variables (inspiratory time, I:E ratio, or expiratory time) the operator can hold constant when the respiratory rate
setting changes. Applies only to the pressure control (PC) mandatory
breath type (including VC+ and BiLevel).
control breath
CPU
dependent alarm
DSENS
Disconnect sensitivity. A setting that specifies the allowable loss (percentage) of delivered tidal volume, which if equaled or exceeded, causes the
ventilator to declare a DISCONNECT alarm. The greater the setting, the
more returned volume must be lost before DISCONNECT is detected. If
the Leak Sync option is in use, DSENS is the maximum allowable leak rate
and is expressed in terms of L/min.
DISS
Diameter index safety standard. A standard for high pressure gas inlet fittings.
ESENS
Expiratory sensitivity. A setting that determines the percent of peak inspiratory flow (or flow rate expressed in L/min in a PAV breath) at which the
ventilator cycles from inspiration to exhalation for spontaneous breaths.
Low settings will result in longer spontaneous inspirations. In an IE Sync
triggered breath, when the PSYNC signal drops below the ESENS setting,
the ventilator cycles to exhalation.
EST
Operators Manual
The valve in the expiratory limb of the ventilator breathing system that
controls PEEP.
f, fTOT
Respiratory rate, as a setting (f) in A/C, SIMV, and BiLevel the minimum
number of mandatory breaths the patient receives per minute. As a monitored value (fTOT), the average total number of breaths delivered to the
patient.
FAILURE
A category of condition detected during SST or EST that causes the ventilator to enter the safety valve open state. A ventilator experiencing a
FAILURE requires removal from clinical use and immediate service.
flow pattern
A setting that determines the gas flow pattern of mandatory volumecontrolled breaths.
GUI
hard bound
high-priority alarm
HME
hPa
humidification type
A setting for the type of humidification system (HME, non-heated expiratory tube, or heated expiratory tubing) in use on the ventilator.
I:E ratio
The ratio of inspiratory time to expiratory time. Also, the operator- set
timing variable that applies to PC and VC+ mandatory breaths.
inspiratory pause
Operators Manual
Glossary-3
Glossary-4
invasive ventilation
kPa
latched alarm
L/min
low-priority alarm
As defined by international standards organizations, an alarm that indicates a change in the patient-ventilator system. During a low-priority
alarm, the yellow low-priority LED indicator lights, the low-priority
audible alarm (one tone) sounds, and the GUI screen shows an alarm
banner with the ( ! ) symbol.
lockable alarm
maintenance
mandatory breath
A breath whose settings and timing are preset; can be triggered by the
ventilator, patient, or operator.
mandatory type
manual inspiration
medium-priority alarm
As defined by international standards organizations, an abnormal condition that requires prompt attention to ensure the safety of the patient.
When a medium-priority alarm is active, the yellow medium-priority LED
indicator flashes, the medium- priority audible alarm (a repeating
sequence of three tones) sounds, and the GUI screen shows an alarm
banner with the ( !! ) symbol.
mode
NIST
non-technical alarm
normal ventilation
Operators Manual
OIM
Operator-initiated mandatory breath. A breath delivered when the operator presses the MANUAL INSP key.
ongoing background
checks
OSC
OVERRIDDEN
The final status of an SST or EST run in which the operator used the override feature. (The ventilator must have ended the test with an ALERT condition.) Failures cannot be overridden.
patient circuit
patient problems
PBW
PC
PE
PEEP
Positive end expiratory pressure. The measured circuit pressure (referenced to the patient wye) at the end of the expiratory phase of a breath.
If expiratory pause is active, the displayed value reflects the level of any
active lung PEEP.
Operators Manual
Glossary-5
PI
PI
PI END
End inspiratory pressure. The pressure at the end of the inspiration phase
of the current breath. If plateau is active, the displayed value reflects the
level of end-plateau pressure.
PIM
PMEAN
PPEAK
primary alarm
An initial alarm.
PS
PSENS
PSOL
PSUPP
P-TRIG
Glossary-6
remedy message
resistance
Operators Manual
The time period during the exhalation phase where an inspiration trigger
is not allowed. The restricted phase of exhalation is defined as the first
200 ms of exhalation, OR the time it takes for expiratory flow to drop to
50% of the peak expiratory flow, OR the time it takes for the expiratory
flow to drop to 0.5 L/min (whichever is longest). The restricted phase
of exhalation will end after five (5) seconds of exhalation have elapsed
regardless of the measured expiratory flow rate.
rise time %
A setting that determines the rise time to achieve the set inspiratory pressure in pressure-controlled (PC), VC+, BiLevel, or pressure-supported (PS)
breaths. The larger the value, the more rapid the rise of pressure.
safety net
safety ventilation
A mode of ventilation active if the patient circuit is connected before ventilator startup is complete, or when power is restored after a loss of five
(5) minutes or more.
service mode
SIMV
SIS
Sleeved index system. A standard for high pressure gas inlet fittings.
soft bound
A ventilator setting that has reached its recommended high or low limit,
accompanied by an audible tone. Setting the ventilator beyond this limit
requires the operator to acknowledge a visual prompt to continue.
SPONT
spontaneous type
A setting that determines whether spontaneous breaths are pressuresupported (PS), tube-compensated (TC), volume-supported (VS), or proportionally assisted (PAV).
SST
Short self test. A test that checks circuit integrity, calculates circuit compliance and filter resistance, and checks ventilator function. Operator
should run SST at specified intervals and with any replacement or alteration of the patient circuit.
Operators Manual
Glossary-7
Glossary-8
STPD
SVO
Safety valve open. An emergency state in which the ventilator opens the
safety valve so the patient can breathe room air unassisted by the ventilator (if able to do so). An SVO state does not necessarily indicate a ventilator inoperative condition. The ventilator enters an SVO state if a
hardware or software failure occurs that could compromise safe ventilation, with the loss of the air and oxygen supplies, or if the system detects
an occlusion.
system fault
TA
Apnea interval, the operator-set variable that defines the breath-tobreath interval which, if exceeded, causes the ventilator to declare apnea
and enter apnea ventilation.
Tb
TE
technical alarm
An alarm occurring due to a violation of any of the ventilator's self monitoring conditions, or detected by background checks.
TI
Inspiratory time, the inspiratory interval of a breath. Also, the operatorset timing variable that determines the inspiratory interval for pressurecontrolled (PC) or VC+ mandatory breaths.
Tm
TPL
Ts
Spontaneous interval portion of SIMV breath cycle; it is reserved for spontaneous breathing throughout the remainder of the breath cycle.
VE TOT
VBS
Operators Manual
Ventilation Assurance
A feature on the 980 Series Ventilator which enables ventilation to continue when a critical system error occurs, by entering the Backup Ventilation (BUV) state.
Ventilator Inoperative
(vent inop)
VIM
VMAX
Peak flow. A setting of the peak (maximum) flow of gas delivered during
a VC mandatory breath. (Combined with tidal volume, flow pattern, and
plateau, constant peak flow defines the inspiratory time.) To correct for
compliance volume, the ventilator automatically increases the peak flow.
VSENS
Flow sensitivity. A setting that determines the rate of flow inspired by the
patient that triggers the ventilator to deliver a mandatory or spontaneous
breath (when flow triggering is selected).
VT
Tidal volume. A setting that determines the volume inspired and expired
with each breath. The VT delivered by some Puritan Bennett ventilators is
an operator-set variable that determines the volume delivered to the
patient during a mandatory, volume-based breath. VT is compliancecompensated and corrected to body temperature and pressure, saturated (BTPS).
V-TRIG
TableGlossary-2.Units of Measure
Operators Manual
cm
ft
Hz
kg
Glossary-9
lb
mL
ms
VA
TableGlossary-3.Technical Abbreviations
Glossary-10
AC, also ac
ASCII
American Standard Code for Information Interchange. A standard character encoding scheme.
CE
CSA
CRC
DC, also dc
EMC
Electromagnetic compatibility.
EN
ETO
Ethylene oxide.
IEC
ISO
LCD
LED
MRI
Operators Manual
Operators Manual
POST
Power-on self-test. Software algorithms to verify the integrity of application software and the hardware environment. Power-on self-test
generally occurs at power on, after power loss, or when the device
resets due to a detected fault.
RAM
Glossary-11
Glossary-12
Operators Manual
A
A/C mode . . . . . . . . . . . . . 10-3110-34
AC power operation . . . . . . . . . . . . 3-2
accessory
compatibility 9-1
part numbers 9-4
adjusting waveform layout . . . . . 3-45
alarm
AC POWER LOSS 6-35
Apnea 6-35
CIRCUIT DISCONNECT 6-35
dependent 6-4
DEVICE ALERT 6-36
High circuit pressure 6-36
High delivered O2% 6-37
High exhaled minute volume 6-38
High exhaled tidal volume 6-38
High inspired tidal volume 6-38
High respiratory rate 6-39
how to test 6-9
INSPIRATION TOO LONG 6-39
latched 6-5
lockable 6-6
Loss of power 6-36
Low circuit pressure 6-39
Low delivered O2% 6-40
Low exhaled mandatory tidal volume 6-41
Low exhaled spontaneous tidal volume 641
Low exhaled total minute volume 6-41
non-technical 6-18
primary 6-4
prioritization 6-16
PROCEDURE ERROR 6-42
reset 6-8
silence 6-8
symbols 6-6
technical 6-17
volume 6-8
Alarm Functions . . . . . . . . . . . . . . . 6-4
alarm settings range, resolution, accuracy
11-19
alarm settings range, resolution, accuracy
11-17
Apnea Ventilation . . . . . . 10-4110-45
apnea ventilation . . . . . . . . . . . . 10-57
Apnea Ventilation in SIMV . . . . . 10-44
B
Background Diagnostic System . 10-74
battery
life 3-25
battery installation . . . . . . . 3-183-22
BDU indicators
audible 2-35
visual 2-27
BiLevel 2.0 option . . . . . . . . . . . . . .A-1
RS-232 commands
RSET 5-5
SNDA 5-6
SNDF 5-10
O
Occlusion . . . . . . . . . . . . . . . . . . . 10-45
Omni-directional LED . . . . . . . . . . 3-30
On-screen Help . . . . . . . . . . . . . . . 1-18
On-screen Symbols and Abbreviations 2-20
2-23
Operation Verification . . . . . . . . . 3-58
oxygen sensor
calibration 4-34
calibration test 4-34
function 4-32
S
Safety Net . . . . . . . . . . . . . . . . . . 10-71
Serial commands . . . . . . . . . . . . . . . 5-5
serial number interpretation . . . . 1-19
settings
alarm 4-16
apnea 4-15
return to previous 4-20
ventilator 4-10
Short Self Test (SST) . . . . . . . . . . 10-77
SIMV . . . . . . . . . . . . . . . . . . . . . . 10-34
SIMV . . . . . . . . . . . . . . . . . . . . . . 10-39
soft bound . . . . . . . . . . . . . . . . . . . 4-3
Spontaneous (SPONT) Mode 10-3910-41
Spontaneous Breath Delivery . . 10-22
SST
how to run 3-48
outcomes 3-51
results 3-50
test sequence 3-48
Status Display . . . . . . . . . . . . 2-282-34
Storage for Extended Periods . . . 7-26
Surface Cleaning of Ventilator Exterior
Surfaces . . . . . . . . . . . . . . . 7-4
symbols
BDU rear panel label symbols and
descriptions 2-11
safety symbol definitions 1-3
shipping label symbols and descriptions 12
System Related Problems . . . . . . 10-73
P
P0.1 maneuver . . . . . . . . . . . . . . . 10-55
Patient Data Parameters . . . 6-436-50
patient data range and resolution 11-191126
PAV+ option . . . . . . . . . . . . . . . . . .D-1
Peak Inspiratory Flow (VMAX) . . . 10-62
PEEP . . . . . . . . . . . . . . . . . . . . . . . 10-67
PEEP restoration . . . . . . . . . . . . . 10-67
Percent Support (PAV+) . . . . . . . 10-68
Percent Support (TC) . . . . . . . . . . 10-68
Plateau Pressure (PPL) . . . . . . . . . . 6-46
Plateau Time (TPL) . . . . . . . . . . . . 10-63
Pneumatic Diagram . . . . . . . . . . . . 2-36
Power On Self Test (POST) . . . . . 10-76
Preparing the Ventilator for Use . 3-37
Pressure Sensitivity (PSENS) . . . . . 10-64
Pressure Support (PSUPP) . . . . . . . 10-68
primary battery installation . . . . . 3-19
Primary display . . . . . . . . . . . . . . . 2-16
Product Assembly . . . . . . . . . . . . . . 3-2
proximal flow option . . . . . . . . . . . F-1
pushpin . . . . . . . . . . . . . . . . . . . . . . 4-5
Q
quick start use . . . . . . . . . . . . . . . . . 4-8
R
respiratory maneuvers
expiratory pause maneuver 10-53
inspiratory pause maneuver 10-50
NIF maneuver 10-54
respiratory mechanics maneuvers
Negative Inspiratory Force maneuver (NIF)
10-54
P0.1 maneuver 10-55
vital capacity maneuver (VC) 10-56
Respiratory Rate (f) . . . . . . . . . . . 10-61
Rise Time % . . . . . . . . . . . . . . . . . 10-69
T
TC
alarms 10-28
monitored patient data 10-28
PBW and tube ID 10-28
technical description 10-27
tube type, tube ID, humidification 4-14
technical assistance . . . . . . . . . . . 1-15
Technical Services . . . . . . . . . . . . . 1-15
TH:TL ratio (BiLevel) . . . . . . . . . . 10-67
Tidal Volume . . . . . . . . . . . . . . . . 10-62
Tube compensation (TC) . . . . . . 10-27
U
Used Part Disposal . . . . . . . . . . . . . 8-1
Using Battery Power . . . . . . . . . . . . 3-3
V
VC+
maximum pressure adjustments 10-21
startup 10-2010-21
ventilating a new patient . . . . . . . . 4-9
ventilating the same patient . . . . . 4-9
ventilator
alarm log 8-2
available languages 5-1
BDU controls and indicators 2-25
BDU front view 2-8
BDU rear label symbols and descriptions 2112-13
BDU rear view 2-10
BDU right side view 2-14, 2-15
Components List 2-5
connectors 2-35
Description 2-2
EST/SST status log 8-3
function 4-1
gas flow overview 10-2
general event log 8-3
GUI front view 2-6
GUI rear view 2-7
Indications For Use 2-4
Operation 4-74-21
patient data log 8-2
service log 8-3
settings log 8-2
system diagnostic log 8-3
Ventilator Logs . . . . . . . . . . . . . . . . 8-2
Ventilator Operating Modes 3-303-34
ventilator operating modes
Normal mode 3-30
Quick Start mode 3-30
Service mode 3-33
Stand-By state 3-31
Ventilator Protection Strategies 4-354-37
ventilator settings
apnea ventilation 10-57
circuit type and PBW 10-59
configuration 3-373-46
disconnect sensitivity (DSENS) 10-70
DSENS 10-70
ESENS 10-70
flow pattern 10-63
Covidien llc
15 Hampshire Street, Mansfield, MA 02048 USA
,,.
www.covidien.com
[T] 1.800.255.6774