Elisa 800: Instructions For Use

Homecare
elisa 800
Pneumology
Neonatology
Anaesthesia
INTENSIVE CARE VENTILATION
Instructions for Use

Sleep Diagnostics
Service
Patient Support
The device operates according to the descriptions in these instructions for use
and on the equipment labelling, provided that it is assembled, operated, main-
tained and repaired according to the enclosed documentation. The device must
be inspected at regular intervals. The device must not be used if found to be de-
fective. Damaged, missing, clearly worn out, warped or contaminated parts must
be replaced immediately. If a repair is necessary, the manufacturer and distributor
recommend requesting advice via telephone or in writing from the nearest re-
gional service centre. Maintenance and repairs must only be carried out at the
service centre or by specialists authorised by the manufacturer. The user of the
device shall have sole responsibility for any malfunction or damage which is due
to improper use, poor maintenance, improper service, improper repairs or mod-
ifications carried out by unauthorised persons.
The devices are provided with serial numbers. Their code system includes the
product group code, year of manufacture and ascending production number for
unique identification.
Ventilator unit 08XX1234

Control unit BEXX1234
XX represents a number which indicates the year of manufacture:
15 = 2015, 16 = 2016, etc.

Contents| 0
0 Contents
0 Contents 3
1 About this manual 9
1.1 About this manual 10
1.2 Safety information in these instructions for use 10
2 Use 11
2.1 Intended use 12
2.2 Areas of application 12
3 General safety instructions 13
3.1 General safety instructions 14
3.1.1 Safety standards 17
3.1.2 Safety functions 18
3.1.3 Work carried out on the device 20
4 Assembly 21
4.1 System overview 22
4.2 Main components 23
4.2.1 Ventilator unit 23
4.2.2 Control unit 25
4.2.3 Valve bar 26
4.2.4 Battery 27
4.3 Cart (option) 28
4.4 Breathing circuit 29
4.5 Tube hanger 29
4.6 Respiratory gas humidification 30
4.6.1 Connection with a passive HME filter 30
4.6.2 Connection with an active respiratory gas humidifier 30
4.7 Nebulized drug delivery 31
4.7.1 Connection of the pneumatic nebulizer set 32
4.7.2 Connection of the mesh nebulizer 33
4.8 Capnometry 36
4.8.1 Connection of the main stream sensor 36
4.8.2 Connection of the side stream sensor 37
5 General information 39
5.1 General functional description 40
5.1.1 Layout of the ventilation screen 40
5.1.2 General operation 41
Instructions for Use elisa 800 | SW 1.05.x | Rev. 10 3

0 | Contents
5.2 Configuration 41
5.2.1 Presetting the ventilation modes 43
5.2.2 Presetting the units 44
5.2.3 Presetting the language 44
5.2.4 Presetting and activating various functions 45
5.2.4.1 Automatic suction routine ASR 45
5.2.4.2 Plimit 45
5.2.4.3 Byflow 45
5.2.4.4 Automatic patient detection APD 46
5.2.4.5 Default ventilation 46
5.2.4.6 Sigh 48
5.2.4.8 Scientific Tool 48
5.2.4.9 Hygiene management 50
5.2.5 Saving trend data to a USB flash drive 51
5.3 Help function 52
5.4 Symbols used on the device 53
5.4.1 Additional symbols used on the packaging 55
5.5 Abbreviations used in the instructions for use and in the user guidance 56
6 Preparing the system for use 61
6.1 Power supply 62
6.1.1 Mains supply 62
6.1.2 Internal power supply (rechargeable battery) 62
6.2 Gas supply 64
6.3 Switching power on and off 65
6.4 Power-on self-test 65
6.5 System test 66
6.5.2 Performing the system test 68
7 Operation 71
7.1 Standby mode 72
7.1.1 Same patient 72
7.1.2 New patient 73
7.1.3 Default ventilation 73
7.1.4 Start ventilation 75
7.1.5 Favourites 75
7.1.6 More functions 75
7.2 Patient interface configuration 75
7.3 Toolbox function keys 77
7.3.1 Help function 77
7.3.2 Screenshot 77
7.3.3 Freeze curve 78
7.3.4 System test 78
7.3.5 Gas supply 78
7.3.6 Battery information 79
7.3.7 Patient data 79
4 Instructions for Use elisa 800 | SW 1.05.x | Rev. 10

Contents| 0
7.8.3 Trend 79
7.3.9 Extended screen display 83
7.4 Ventilation 83
7.4.1 Set ventilation mode 84
7.4.2 Switch between ventilation modes 84
7.4.3 Set ventilation parameters 86
7.4.4 Alarm limits 87
7.4.5 Drug nebulization 87
7.4.6 Tube compensation 88
7.5 System settings 89
7.5.1 Settings 89
7.5.2 Service 90
7.5.3 Hygiene 91
7.5.4 Locking and unlocking the screen 92
7.5.5 Further buttons 92
8 Manoeuvres 93
8.1 Automatic Suction Routine (ASR) 94
8.1.1 Suction with open suction systems 94
8.1.2 Suction with closed suction systems 96
8.1.3 Suction with semi-closed suction systems 97
8.2 P0.1 97
8.3 HOLD manoeuvre 98
8.3.1 Inspiratory Hold (Insp. Hold) 98
8.3.2 Expiratory Hold (Exp. Hold) 98
8.3.3 Manual breath 98
8.4 Maximum inspiratory pressure (MIP) 99
8.6 Sigh function 100
8.6.1 Inspiratory sigh 101
8.6.2 Expiratory sigh 102
9 Measurements and graphics 103
9.1 Curve display 104
9.2 Instant View window 104
9.3 Weaning window 106
9.4 Loop window 106
9.5 Data Table window 108
10 Monitoring 109
10.1 Oxygen measurement (O2) 110
10.2 Capnometry (CO2) 110
10.3 VIT - Ventilator-integrated tomography 111
11 Alarms and troubleshooting 113
11.1 Alarm system 114
11.1.1 Alarm pause 115
11.2 Alarm priorities 116
11.3 Alarm messages during operation 116

0 | Contents
11.4 Alarm messages during power-on self-test 132

11.5 Alarm messages during system test 135
12 Cleaning, disinfection and sterilisation 139
12.1 General information 140
12.1.1 Initial operation 140
12.2 Cleaning and disinfection 141
12.2.1 Ventilator unit and control unit 141
12.2.2 Machine cleaning with disinfection of the valve bar 141
12.3 Sterilisation 144
12.3.1 Valve bar 144
12.4 Visual inspection 145
13 Maintenance 147
13.2 Maintenance intervals 148
13.2.1 Annual maintenance 148
13.2.2 Maintenance every 6 years 148
14 Technical specifications 149
14.2 Supply 151
14.3 Technical data 152
14.4 Control unit 153
14.5 Default parameters 153
14.6 Increments and maximum performance range 154
14.7 Measuring functions 157
14.8 Guidance and manufacturer's declaration 158
A Default parameters 163
A.1 Default parameters 164
A.1.1 Default parameters 164
A.1.2 Adjustment ranges 165
A.1.3 Default alarm limits 165
B Ventilation modes and parameters 167
B.1 Default settings 168
B.2 Default ventilation 168
B.3 Ventilation modes 168
B.3.1 BiLevel ST 170
B.3.2 Dynamic BiLevel ST 171
B.3.3 Dual BiLevel ST 172
B.3.4 BiLevel 173
B.3.5 Mandatory BiLevel 174
B.3.6 Dynamic BiLevel 175
B.3.7 Dual BiLevel 176
B.3.8 Optional BiLevel 176

Contents| 0
B.3.9 Flexible BiLevel 178

B.3.10 PC-SIMV 179
B.3.11 PSV 180
B.3.12 Dynamic PSV 181
B.3.13 Proportional PSV 182
B.3.14 CPAP 183
B.3.15 VCV 184
B.3.16 PLV 185
B.3.17 VC-SIMV 186
B.3.18 Optional VCV 187
B.3.19 Flexible VCV 188
B.3.20 Volume-adaptive BiLevel 189
B.3.21 PC APRV 190
B.3.22 PCV 191
B.3.23 CPR 192
B.3.24 HFOT 194
B.4 Ventilation parameters 195
B.4.1 Trigger 198
B.5 Apnoea ventilation 199
B.6 Setting alarm limits 200
B.7 Overview of alarm limits 201
B.7.1 Ventilation alarms 201
B.7.2 Sensor alarms 202
C Drug nebulization 203
C.1 Intended use 204
C.2 Drug nebulization 204
C.2.1 Pneumatic nebulization 204
C.2.2 Mesh nebulization 207
D Capnometry 209
D.1 Intended use 210
D.2 Measuring principle 210
D.3 Power supply 210
D.4 Breathing circuit 210
D.4.1 Respiratory gas humidification 211
D.4.2 Drug nebulization 211
D.5 Capnometry 211
D.5.1 Zeroing of the CO2 sensor 212
D.5.2 CO2 measurement 213
D.5.3 Trigger 214
D.5.4 Leakage compensation 214
D.6 Alarms 215
D.6.1 Alarm limits 215
D.6.2 Status light of the CO2 sensors 215

1 | About this manual
- This page is intentionally left blank. -

About this manual | 1
1 About this manual
1.1 About this manual 10

1.2 Safety information in these instructions for use 10

1 | About this manual
1.1 About this manual

These instructions for use describe the intended use and the operation of the
following product:
elisa 800 | Intensive care ventilator | Software version 1.05.x
Depending on the configuration of the intensive care ventilator, the basic instruc-
tions for use are supplemented with optional appendices.
The manufacturer reserves the right to further develop the device and/or carry
out changes in terms of technical progress.
The manufacturer's and distributor's contact details are stated on the back cover.
1.2 Safety information in these instructions for use

All warnings and precautions must be read and observed!
The symbols below identify dangerous situations which may occur when users fail
to observe these instructions for use.
Refers to dangerous situations which may occur when failing to

observe the present instructions for use.
"Warning" refers to a situation which may cause injuries to the

Warning
user or the patient.
"Caution" refers to a situation which may cause damage to the
Caution
equipment.

Use | 2
2 Use
2.1 Intended use 12

2.2 Areas of application 12

2 | Use
2.1 Intended use

elisa 800 is an intensive care ventilator which is designed for invasive and non-in-
vasive ventilation of adults and children with a minimum body weight of 3.0 kg.
Optionally, elisa 800 can also be used to ventilate neonates with a minimum body
weight of 0.5 kg (feature available with future software versions).
2.2 Areas of application

elisa 800 is designed for stationary use and intra-hospital transport of patients.
The ventilator must not be used:
• in close proximity to nuclear magnetic resonance equipment

(MRI, NMR DEVICES)
• in potentially explosive areas
• in the presence of flammable anaesthetics or highly flamma-
Warning ble substances
• in hyperbaric chambers
• during out-of-hospital transport of patients
• in EMS settings and ambulances
• in aircrafts or helicopters

General safety instructions | 3
3 General safety instructions
3.1 General safety instructions 14

3.1.1 Safety standards 17
3.1.2 Safety functions 18
3.1.3 Work carried out on the device 20

3 | General safety instructions
3.1 General safety instructions

Reference
These instructions for use describe the product:
elisa 800 | Intensive care ventilator | Software version 1.05.x
Safe operation
In order to guarantee the safe operation of elisa 800, the system must only be
used as described. Before putting the system into operation, users must familiarise
themselves with these instructions for use. As a matter of principle, all guidelines
in these instructions for use and other legal provisions must be observed for the
use of a ventilator.
Secure positioning
Verify the secure positioning of the ventilator unit which must not be tilted or
set up at an angle.
Patient safety
elisa 800 may only be operated by qualified medical staff in order to guarantee an
adequate intervention in the event of a device malfunction.
Patients connected to the device require continuous surveillance by specialist

staff. If a patient is connected to the system, make sure that the alarm limits are
adapted to the patient condition and the alarms are activated.
Keep a manual resuscitation bag ready to be able to continue

ventilation in the event of a device malfunction.
Warning
Accessories:
Accessories approved for use with elisa 800 are specified in the "elisa 800 list of
accessories". If employing different accessories, the user is required to test and
demonstrate the safety of the system prior to its use. All accessories used must
have an EC declaration of conformity in compliance with the medical device di-
rective 93/42/EEC and they must have passed the elisa 800 system test.
The device shall only be applied within the scope of its intended use.
Restrictions regarding the application of the breathing circuits used must be ob-
served (drug nebulization). The use of tube-within-a-tube systems (coaxial tubing
system) is not permitted.
Do not reuse components intended for single use.

Warning

Classification
elisa 800 is a Class IIb device according to Directive 93/42/EEC concerning medi-
cal devices, Annex IX, section 1.3., rule 3, section 3.1., rule 9 and section 3.2., rule
11.
Classification according to EN 60601-1 Medical electrical equipment - General

requirements for basic safety and essential performance:
DEVICE OF PROTECTION CLASS I, with internal power supply. Protection

against electric shock hazards by protective earth terminal.
APPLIED PARTS with an electrical connection:
• Mesh nebulizer (Type BF)
• CO2 sensor (Type BF)
• VIT SensorBelt (Type BF)
Always connect type BF equipment to the device before connect-

ing it to the patient
Warning
Be sure to connect the equipment to the appropriate interfaces

on the back of the device. Check that all connectors are properly
Warning secured.
APPLIED PARTS that conduct patient gases:

• Parts integrated in the elisa 800 system (such as assemblies or modules) are
inspected by the manufacturer.
• External parts conducting patient gases, which are connected to the elisa
800 system, are inspected by the manufacturers of the parts concerned. For
details, please refer to the documents enclosed with these parts.
CONTINUOUS OPERATION if applied in compliance with the INTENDED USE

and within the indicated temperature limits.
Electrical hazard
elisa 800 is exclusively designed for use in an electrical environment according to
VDE 0100 part 710 or EN 60601-1. elisa 800 must not be used if there are doubts
concerning the quality and function of the protective earthing of the electrical
installation.
The housing must be dry before the device is connected to the mains supply. It
must be ensured that the supply voltage corresponds to the ratings on the type
plate on the back panel of the device.
The system must be stored and operated at the temperature and humidity levels

indicated in chapter 14 "Technical specifications".

The system must always be disconnected from the power supply before cleaning,
repair or maintenance work.
Potential equalisation
The potential equalisation connection has been designed for a potential equal-
ization conductor according to DIN 42 801 and EN/IEC 60601-1. The purpose
of this connection is the equalisation of the potentials of the system and that of
other medical electrical equipment which may be touched at the same time.
Connection cable: We recommend using the connection cable from Haeberle
GmbH + Co. KG (e.g., part number 21880 for a 1-metre cable) according to the
manufacturer's directions.
Do not employ the equalisation cable as a protective earth conductor.
Fire hazard
elisa 800 must not be used in potentially explosive atmospheres or in the pres-
ence of flammable anaesthetics.
Risk of electromagnetic disturbance

Devices that generate electromagnetic disturbance at levels exceeding the values
of EN 60601-1-2 can affect the safe operation of the device and endanger the
patient.
Devices that generate high frequency fields and are installed close to the system
can affect the safe operation of elisa 800 and endanger the patient.
The use of mobile communications equipment at a distance of less than 30 cm
from the device can affect the safe operation of elisa 800 and endanger the patient.
elisa 800 must not be used in close proximity to nuclear magnetic

resonance equipment (MRI, NMR devices).
Warning
Electromagnetic compatibility:
elisa 800 is only intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The users of elisa 800 can contribute
towards avoiding electromagnetic interference by maintaining the minimum dis-
tance between portable and mobile high frequency communications equipment
(transmitter) and elisa 800.
The use of other electrical devices, e.g., power cords, may result in
increased emissions or decreased immunity performance of elisa
Warning 800. This may put the patient at risk.

Using other electrical devices with elisa 800 or in its vicinity can
cause interference. The correct performance of the device must
Caution be verified prior to connecting the patient to elisa 800.
Detailed information on electromagnetic compatibility can be

Remark
found in chapter "14.8 Guidance and manufacturer's declaration".
3.1.1 Safety standards

The intensive care ventilator was developed and manufactured according to the
following safety standards:
EN 60601-1
Medical electrical equipment – General requirements for basic safety and essen-
tial performance
EN 60601-1-2
tial performance – Collateral standard: Electromagnetic compatibility - Require-
ments and testing
EN 60601-1-6
tial performance – Collateral standard: Usability
EN 60601-1-8
Medical electrical equipment – General requirements for basic safety and es-
sential performance – Collateral standard: Alarm systems: General requirements,
tests and guidance for alarm systems in medical electrical equipment and medical
systems.
EN 80601-2-12
Medical electrical equipment – Particular requirements for basic safety and essen-
tial performance of critical care ventilators
EN 80601-2-55
Medical electrical equipment – Particular requirements for the basic safety and
essential performance of respiratory gas monitors
EN 62304
Medical device software – Software life-cycle processes

EN 62366
Medical devices – Application of usability engineering to medical devices
ISO 11195
Gas mixers for medical use – Stand-alone gas mixers
ISO 14971
Medical devices – Application of risk management to medical devices
ISO 15001
Anaesthetic and respiratory equipment – Compatibility with oxygen
3.1.2 Safety functions

Power-On Self-Test
When switched on, the device performs the power-on self-test: the hardware
and software modules whose function is relevant for the safety concept and the
supply are checked. For safety reasons it is not possible to bypass this test.
For a list of all alarm messages during the power-on self-test,

Remark please refer to chapter "11.4 Alarm messages during power-on
self-test".
Alarms were implemented in the ventilator as safety functions in order to warn

the user if the patient is at risk.
Device alarms Monitoring

Gas supply
Electrical supply
Sensors
User interface
Device control system
Visual and audible alarms
VIT module (if available)
External components (CO2 sensor, mesh nebulizer)

All device alarms are evaluated during ventilation, in standby

mode and when the automatic patient detection function
does not detect a patient. An alarm is triggered when appli-
cable.
Patient alarms Monitoring

Airway pressures
Tidal volume / minute volume
Respiratory rates (overall/spontaneous)
Leakage
O2 and CO2 concentration
Patient alarms are only evaluated during ventilation and

when the automatic patient detection function detects a pa-
tient. An alarm is triggered when applicable.
System test
As a matter of principle, a system test must be carried out before the ventilator
is used.
Never carry out a system test while a patient is connected to

the device.
Warning
The system test ensures that all safety-related functions and components are
tested before the ventilator is used. The system test can be bypassed in the event
of an emergency.
If the system test was bypassed, the system cannot determine the correct values
of the currently used breathing circuit, which is necessary for optimal compliance
and resistance compensation. In this case, the measurement values of the last
system test are used.
If accessories were modified or the breathing circuit was exchanged, the system
may not be operating within the specified accuracy and tolerance ranges.

3.1.3 Work carried out on the device

Repairs, service and maintenance on the device must only be carried out by au-
thorised personnel. The maintenance intervals and measures are described in
chapter "13 Maintenance".
Do not work on the device while a patient is being ventilated.

Warning

Assembly | 4
4 Assembly
4.1 System overview 22

4.2 Main components 23
4.2.1 Ventilator unit 23
4.2.2 Control unit 25
4.2.3 Valve bar 26
4.2.4 Battery 27
4.3 Cart (option) 28
4.4 Breathing circuit 29
4.5 Tube hanger 29
4.6 Respiratory gas humidification 30
4.6.1 Connection with a passive HME filter 30
4.6.2 Connection with an active respiratory gas humidifier 30
4.7 Nebulized drug delivery 31
4.7.1 Connection of the pneumatic nebulizer set 32
4.7.2 Connection of the mesh nebulizer 33
4.8 Capnometry 36
4.8.1 Connection of the main stream sensor 36
4.8.2 Connection of the side stream sensor 37

4 | Assembly
4.1 System overview

The standard components of the intensive care ventilator elisa 800 are:
A Control unit
B Ventilator unit (including valve bar and battery)
Mesh nebulizer (not shown)
Furthermore, the ventilation system can be expanded to include the following

options:
C Cart with height-adjustable standard rail

• Tube hanger (not shown)
• VIT option (including VIT starter kit) (not shown)
• Capnometry package (not shown)

Assembly | 4
4.2 Main components

4.2.1 Ventilator unit
Front
A A
C E G
D F
H
B
J
A Alarm indicators of the ventilator unit

B ON switch
C Port I
D Expiratory port
E Port II
F Inspiratory port
G Pneumatic nebulizer connection
H Handle or standard rail (on both sides)
J Plug for system test
The ventilator and the connected accessories must not be cov-

ered during operation or while the internal power supply system
Caution is charging.

4 | Assembly
Back
O E
D
G
A C F
B
N
H K I J
M
A Oxygen supply K Serial PDMS interface

B Service port L Power input
C Compressed air supply M Potential equalisation pin
D Mechanical interface for control N Battery compartment
unit O Type plate
E Connections for control unit I & II
F Connection for 3rd gas (option)
G Fan
H VIT interface (option)
I Interface for mesh nebulizer
J Serial CO2 port
Only the original mesh nebulizer may be connected to the mesh

nebulizer interface.
Caution
Only devices which comply with the EN 60601-1 and/or EN

60950 standard may be connected to the serial interfaces of elisa
Caution 800.
The service port is only intended for use by authorised service

staff for maintenance purposes.
Caution

Assembly | 4
For potential equalisation purposes, the ventilator can be connect-

ed to the appropriate device at the intensive care bed by means of
Caution the appropriate cable.
4.2.2 Control unit
B B
D
E
A Control unit
B Alarm indicators of the control unit
C VESA FDMI
D Control unit arm stand
E USB interface
The elisa 800 control unit is usually placed on the ventilator unit by means of the
arm stand. The control unit has a VESA Flat Display Mounting Interface (FDMI)
which allows it to be installed separately.
If you would like to place the control unit in a location other than
Remark on the ventilator unit, you will require the optional extension
cable for the monitor.
Only approved accessories may be connected to the USB inter-

face (refer to separate accessory list).
Caution

4 | Assembly
4.2.3 Valve bar

The elisa 800 valve bar enables a quick exchange of all patient-side connections
and is composed of the 3 following elements:
A Expiratory flow sensor

B Expiratory valve
C Inspiratory valve
A B C
All valve bar components must be prepared before a patient may

be connected to the ventilator.
Warning
E
D F
Actuate the respective release lever to be able to remove the individual elements
one after another.
D Release lever for expiratory flow sensor

E Release lever for expiratory valve
F Release lever for inspiratory valve

Assembly | 4
The valve bar is assembled in reverse order. When inserting the components,
make sure that the mechanical locking device clicks into place.
Observe the correct sequence when inserting the inspiratory

Remark
and expiratory valve!
4.2.4 Battery
elisa 800 can be equipped with a maximum of two batteries. One battery is usually
included in the delivery. To insert or change a battery, remove the battery com-
partment cover on the back of the ventilator. To do so, open the screws manually.
Remove the new battery from its packaging and push it into one of the two
compartments as shown in the illustrations. The guides allow the battery to be
inserted only in one orientation. The capacity indicator faces out.
If you use only one battery, you can place it in any of the two
Remark
battery compartments.
Close the battery compartment with the cover. For further information on using
the battery, please refer to chapter "6.1.2 Internal power supply (rechargeable
battery)".

4 | Assembly
4.3 Cart (option)

Place the ventilator on the cart. Be sure to hold it only at the handles on the side.
Fasten the ventilator using the locking mechanism on the bottom of the platform.
The cart has a height-adjustable standard rail to which accessories can be fas-
tened.
Do not use the cart in case of apparent damage.

Warning
All devices and accessories must be securely fastened to the cart

and checked for tightness. Insufficient fastening can result in dam-
Warning age to the device and/or personal injury.
The user must apply the brakes on the cart wheels during sta-
tionary use of the ventilator.
Caution
Do not sit or stand on the cart!

Caution
In addition to elisa 800, the cart accepts a maximum load of 10

kg, which is limited to 5 kg per standard rail on the cart or ven-
Caution tilator unit.

Assembly | 4
4.4 Breathing circuit

Operate elisa 800 only in conjunction with breathing circuits and accessories
that meet the requirements specified in chapter "3.1 General safety instructions".
Compliance, resistance and leakage of the tubing system used are measured indi-
vidually in the system test.
Do not use any anti-static or conductive tubes or breathing cir-

cuits as they may pose an electrical hazard to the patient!
Warning
Using a tube hanger is recommended in order to guide the tubing

Remark
system between the ventilator and the patient.
4.5 Tube hanger

A tube hanger is optionally available as a strain relief for the ventilation tubes.You
can fasten the hanger to one of the two side handles on the ventilator unit.

4 | Assembly
4.6 Respiratory gas humidification

For warming and humidifying the inspired air, elisa 800 can be combined with var-
ious accessories for respiratory gas conditioning. Use only equipment that meets
the requirements specified in chapter 3.1 General safety instructions.
To avoid additional flow resistances, filter systems (e.g., HMEs)

should not be used at the same time as active humidifiers!
Warning
4.6.1 Connection with a passive HME filter

Connect the passive HME filter between the Y-connector and the patient.
Filters increase the dead space volume and the resistance of the
Remark
ventilation system.
4.6.2 Connection with an active respiratory gas humidifier

Fasten the active humidifier to the standard rail of the cart and integrate it into
the ventilation system.

Assembly | 4
For additional information on connecting the breathing circuit

Remark to the active respiratory gas humidifier, refer to the information
provided by the manufacturer.
Active humidifiers increase the resistance of the ventilation sys-

tem!
Warning
4.7 Nebulized drug delivery

Medication can be nebulized with elisa 800 by means of the pneumatic nebulizer
or the mesh nebulizer.
Remark Ensure that all connections are secure and tight.
Remark The nebulizer can be used within the patient environment.
HMEs or bacteria filters between the nebulizer set and the pa-
tient must not be used during drug nebulization. There is a risk of
Warning increasing the airway resistance!

4 | Assembly
4.7.1 Connection of the pneumatic nebulizer set

The nebulizer set can be integrated on the inspiratory side of the breathing circuit
to avoid additional dead space volume.
Remark It must be ensured that the nebulizer set is in an upright position.
Alternatively, the nebulizer set can be integrated between the HME filter and the
tube.

Assembly | 4
The pneumatic nebulizer set should be measured in the system

test before use for the best possible application of oxygen, vol-
Remark
ume, and pressure during nebulization. This helps achieve an al-
most complete compensation for all parameters.
4.7.2 Connection of the mesh nebulizer

The inhalation unit of the mesh nebulizer set consists of the following compo-
nents:
A Closing cap
B Medication chamber A
C Patient connection adapter
B
The mesh nebulizer can be integrated on the inspirato-
ry side of the breathing circuit to avoid additional dead C
space volume. Using the connection cable, connect the
inhalation unit to the interface for the mesh nebulizer
on the back of the ventilator.

4 | Assembly
HMEs or bacteria filters between the nebulizer set and the pa-
tient must not be used during drug nebulization. There is a risk of
increasing the airway resistance!
Warning
To enable monitoring of the medication level, the nebulizer head

Remark must be perpendicular to the tubing (90° angle). Otherwise, false
alarms may occur during nebulization.
patient tubing
90°
Remark Ensure that all connections are secure and tight.
The inhalation unit can be adapted to the position of the tube via
Remark
the patient connection adapter.
First connect the mesh nebulizer to the power supply before it

comes into contact with the patient or with the respired gases.
Warning
Be sure to connect the mesh nebulizer to the appropriate inter-

face on the back of the device. Secure the connector with the
Warning screws.

Assembly | 4
Alternatively, the mesh nebulizer can be integrated between the HME filter and
the tube.

4 | Assembly
4.8 Capnometry
Connect the CO2 sensor to the serial interface of the ventilator using the con-
nection cable.The system automatically recognises whether a main stream or side
stream sensor is connected.
Remark The CO2 sensor can be used within the patient environment.
First connect the CO2 sensor to the power supply before it

Warning
Be sure to connect the CO2 sensor to the appropriate interface

on the back of the device. Secure the connector with the screws.
Warning
4.8.1 Connection of the main stream sensor

Assembly | 4
Integrate the measuring cuvette between the Y-connector and HME filter close to
the patient. After zeroing of the CO2 sensor, push it on to the measuring cuvette.
4.8.2 Connection of the side stream sensor

Using the approved support, fasten the side stream sensor to either one of the
two side handles of the ventilator. Using a sampling tube, connect the sensor to
the HME filter with the appropriate connection.
The sampling tube must be replaced after each patient to avoid

cross-contamination.
Warning

4 | Assembly

General information | 5
5 General information
5.1 General functional description 40

5.1.1 Layout of the ventilation screen 40
5.1.2 General operation 41
5.2 Configuration 41
5.2.1 Presetting the ventilation modes 43
5.2.2 Presetting the units 44
5.2.3 Presetting the language 44
5.2.4 Presetting and activating various functions 45
5.2.4.1 Automatic suction routine ASR 45
5.2.4.2 Plimit 45
5.2.4.3 Byflow 45
5.2.4.4 Automatic patient detection APD 46
5.2.4.5 Default ventilation 46
5.2.4.6 Sigh 48
5.2.4.8 Scientific Tool 48
5.2.4.9 Hygiene management 50
5.2.5 Saving trend data to a USB flash drive 51
5.3 Help function 52
5.4 Symbols used on the device 53
5.4.1 Additional symbols used on the packaging 55
5.5 Abbreviations used in the instructions for use and in the
user guidance 56

5 | General information
5.1 General functional description

5.1.1 Layout of the ventilation screen
The ventilation screen is divided into the following areas:
A B C D E
G J K L
A Alarm window
B Patient interface configuration
C Tool box
D Ventilation and apnoea mode window
E Alarm pause key
F Alpha key (stops the input or returns to ventilation)
G Weaning window (extended screen display)
H Loop window (extended screen display)
I Data table window (extended screen display)
J Curve window
K Instant View window
L Selector
M Menu window
N Enter key (confirms selected actions or parameters)
By touching panes (G) and (H), you enlarge the views and they move to the centre
of the screen.
When you touch pane (I), the table extends to the right, presenting a total of 15
values in 3 columns.

5.1.2 General operation

The intensive care ventilator is controlled via the capacitive multi-touch screen
of the control unit. Windows or menus are opened or closed immediately after
selecting the appropriate button.
Changes, such as entering a parameter, changing the ventilation mode or starting

and stopping a function, must always be confirmed with the Enter key. In this case,
the Enter key is marked in green.
If you activate a button, its colour will change from grey to green.
To change a parameter, select the corresponding button.The selector is shown on

the right-hand side of the screen. Turn the selector by swiping to the new value
and confirm the selection with the Enter key.
To cancel the entry and return to the main screen, press the button of the select-
ed parameter once again or close the selector with the Alpha key.
5.2 Configuration
Via the "Configuration" button on the system test screen, the system can be con-
figured to match the requirements of different situations (also refer to chapter
"6.5 System test"). The configuration menu allows the user to set and preselect
the following items:
• ventilation modes
• units
• language for the user interface
• various functions, including their activation
• default ventilation parameters
• storage of trend data on a USB flash drive
Your authorised sales and service partner will be available for

Remark
assistance when you configure the device for the first time.
Your authorised sales and service partner will provide the access
Remark
code for the configuration area.

To change configuration levels, you will first have to "save" your

selections or "cancel" the procedure. When you leave a configu-
Remark
ration level with the button in the upper right hand corner of the
screen without saving your selections, these will be lost.
Remark Functions, modes, and settings that can be activated or set at

the respective configuration level are identified with this icon
throughout the manual. You will find detailed descriptions of the
functions, modes, and settings in the corresponding chapters.

5.2.1 Presetting the ventilation modes
A maximum of 10 tab positions is available to which you can assign your preferred
ventilation modes. To do so, activate the button of the mode you want to include
in your tab bar. A window opens showing an illustration and a short description
of the selected mode.
Then touch the button in the tab bar to which you want to assign the mode.
The ventilation mode assigned to the first tab of the tab bar au-
Remark
tomatically becomes the default ventilation mode.
You can save this setting at any time with "Save", abort the procedure with "Can-
cel" or return to the default settings with "Default".

5.2.2 Presetting the units
5.2.3 Presetting the language

5.2.4 Presetting and activating various functions
5.2.4.1 Automatic suction routine ASR

Besides the suction routine for open suction systems, an additional suction rou-
tine for closed or semi-closed suction systems can be activated here (see chapter
"8.1 Automatic Suction Routine (ASR) 2").
5.2.4.2 Plimit
A pressure limiting function (Plimit) is available as a safety feature that limits
undesired pressure peaks. It opens the overpressure valve, thus terminating the
ventilation stroke. This function can be configured to be automatically set, or a
manual adjustment by the user can be selected. Depending on the selected ven-
tilation mode, the limit will be set at 10 mbar or 10 cmH2O above the Pmax. or
Pinsp. setting.
5.2.4.3 Byflow
The manual byflow adjustment function can be enabled and disabled from the
configuration menu. When disabled, i.e., the button is removed from the display,
the byflow setting auto-adjusts in response to the patient requirements. Byflow
adjustment by the user is only recommended in conjunction with uncuffed tubes
and helmet ventilation.

5.2.4.4 Automatic patient detection APD

During ventilation with a tube or an endotracheal cannula, the automatic patient
detection feature prevents inadvertent activation of the standby function while a
patient is connected. Once activated at the configuration level, the safety feature
is permanently enabled for invasive ventilation. To terminate ventilation by activa-
tion of the standby function, the tubing system needs to be disconnected first.The
ventilator detects the disconnection, and the dimmed standby button is enabled.
It is now possible to terminate the ventilation by activating the standby function.
Caution:The automatic patient detection feature is only available for invasive ven-
tilation by means of a tube or endotracheal cannula. This safety feature is disabled
for non-invasive ventilation modes.
5.2.4.5 Default ventilation

With the "Default ventilation" function, the parameters can be adapted to the
patient's clinical requirements at the beginning of the ventilation session.
The following options are presented in the configuration menu for assistance:
Weight: The tidal volume or the delta pressure will be determined on the basis
of the actual weight.
Size: The tidal volume or the delta pressure will be determined on the basis
of the calculated ideal weight derived from the body height. With this
option, the patient interface will display the tidal volume in l/kg IBW.

An analysis function is available for pressure-controlled ventilation modes. In

the first 30 seconds, this function determines the pressure setting necessary to
achieve the set tidal volume. When the analysis function is deactivated, the nec-
essary pressure is not determined. Instead, a fixed delta pressure of 10 mbar will
be applied.
After input of the weight, the desired tidal volume is set per kg of body weight.
The default value is 6 ml per kg of body weight.

5.2.4.6 Sigh
Both the inspiratory and the expiratory sigh function can be activated and deacti-
vated. For more information, please refer to chapter "8.6 Sigh function".
5.2.4.8 Scientific Tool

elisa 800 allows the ventilation and VIT data to be saved to a USB stick for sci-
entific purposes. This Scientific Tool function is activated and deactivated on this
screen. When the function is enabled, the corresponding key will be displayed in
the VIT view screen.You start and stop storing the ongoing ventilation procedure
by touching the key. An external software program is available for conversion and
analysis of the data.
Please contact your authorised service partner if you need the
Remark
conversion and analysis software "Scientific Data Tool 1.0".


5.2.4.9 Hygiene management

To reduce the risk of nosocomial infection (hospital-acquired infection) the venti-
lator has a hygiene management function, which monitors the timely replacement
of accessories that are in direct contact with the patient (tubing system, valve bar,
suction system, HME filter, nebulizer, and CO2 adapter). The hygiene management
function can be configured according to the hygiene policy of the respective unit,
or it can be disabled.
By entering the maximum period of service for an accessory with the selector,
this accessory will be activated.
When the function is set to OFF, the usage of the accessory will not be monitored
by the hygiene management function.
To view the remaining time of use or confirm the replacement of an accessory,

select the "More Functions" button to access the hygiene management function.
Accessories which were disabled (set to OFF) at the configuration level will not
be displayed though.

5.2.5 Saving trend data to a USB flash drive

This function can be used to save trend data to a USB flash drive.
Initially, the button is dimmed. It becomes active when a USB flash drive is con-
nected to the control unit. Use the selector to define the time window for the
trend to be saved.
Only approved accessories may be connected to the USB inter-

face (refer to separate accessory list).
Caution
Additional functions
The following functions can be activated and deactivated:

• Patient category
- Adult
- Paediatric
• Intensive care ventilation
- with tube (including tube compensation)
- with endotracheal cannula (including tube compensation)
• Non-invasive ventilation
- with mask
- Highflow Oxygen Therapy
• CO2 available / not available
• Mesh nebulizer available / not available

5.3 Help function

You can press the Help button to view additional information.
On the power-on self-test screen and the system test screen, you will find a Help
button which can be pressed to view instructions for the correct assembly and
positioning of the valve bar components.
Press the button again to close the Help window.

In the standby mode and during ventilation, you can activate the Help function to
obtain information about the different ventilation modes, parameter settings, and
alarm limits. Use the Help button in the toolbox to view the Help texts (also refer
to chapter "7.3 Toolbox function keys").
Press the button again to close the Help window.
5.4 Symbols used on the device

On switch
Power indicator
Gas outlet
Gas inlet
Port I & II
Expiratory flow sensor
Nebulizer port
Release lever for valve bar

Connection control unit I & II
BF type applied part
VIT interface
Serial interface
Unlock arm stand
Lock arm stand
Equipotential
Battery compartment
Observe service instructions!
Observe instructions for use!
Do not step onto surface!
Do not sit!
Follow the instructions for use!
elisa 800 fulfils the requirements of Directive 93/42/EEC concerning medical devic-
es, provided it is operated according to the instructions for use.
'0123' is the identification number of the notified body.
Weight in kg
Manufacturer and date of manufacture

20xx
IP22 Protection class according to DIN EN ISO 80601-2-12
This symbol identifies electrical and electronic devices that must not be disposed
of with ordinary, unsorted household waste but must be treated separately. Please
contact the manufacturer for more information regarding the disposal of the de-
vice.

5.4.1 Additional symbols used on the packaging
Medical device, handle with care
Humidity from 0 to 99%, no condensation
Atmospheric pressure from 50 kPa to 110 kPa
Fragile, handle with care
Transport and storage at temperatures from -20°C to +60°C
This side up
Box supports a maximum load of 30 kg
Keep dry
Protect from heat and radioactive radiation

5.5 Abbreviations used in the instructions for use and in

the user guidance
Ventilation modes
VCV Volume-controlled ventilation
PLV Pressure limited ventilation (VCV with pressure limitation)
VC-SIMV Synchronised intermittent mandatory ventilation –
volume controlled
Opt.VCV Optional VCV
Flex.VCV Flexible VCV
PCV Pressure-controlled ventilation
PC-SIMV Synchronised intermittent mandatory ventilation –
pressure controlled
PC-APRV BiLevel airway pressure release ventilation
BiLevel Pressure-controlled BiLevel ventilation
BiLevel ST Pressure-controlled BiLevel ventilation (spontaneous/timed)
Dyn. BiLevel ST Pressure-controlled BiLevel ST ventilation, dynamic
Dual BiLevel ST dual pressure-controlled BiLevel ST ventilation
Mand. BiLevel Mandatory BiLevel ventilation
Opt. Bi-Level Optional BiLevel ventilation
Dyn. BiLevel Pressure-controlled BiLevel ventilation with volume guarantee
Dual BiLevel Dual BiLevel ventilation
Flex. BiLevel Flexible BiLevel ventilation
VA BiLevel Volume-adaptive BiLevel ventilation
CPAP Continuous positive airway pressure
PSV Pressure-supported spontaneous breathing
Dyn. PSV Dynamic pressure support
Prop. PSV Proportional pressure support
CPR Reanimation mode
Further abbreviations
IV Invasive ventilation
NIV Non-invasive ventilation
APD Automatic patient detection
ASR Manoeuvre for automatic bronchial suction
(Automatic Suction Routine)
Endot. Endotracheal tube

Trach. Tracheal tube

Expirat. (here) expiratory tube compensation
Compensat. Tube compensation level
Adult Patient category: Adult
Paediatric Patient category: Paediatric
Pmax Upper pressure limit, configured value
Pmin Lower pressure limit, configured value
Plimit Safety pressure and adjustable alarm limit
Pmean max Maximum mean airway pressure, adjustable alarm limit
Pmean min Minimum mean airway pressure, adjustable alarm limit
Pinsp Inspiratory pressure, configured value
PS Pressure support, configured value
PEEP Positive end-expiratory pressure, configured value
PEEP max maximum positive end-expiratory pressure, adjustable alarm limit
PEEP min minimum positive end-expiratory pressure, adjustable alarm limit
Ppeak Peak pressure of the last breath, measured value
Pplateau Plateau pressure, measured value
Pplateau max Plateau pressure, adjustable alarm limit
Pmean Mean airway pressure, measured value
Pmin Minimum airway pressure of the last breath, measured value
Ppeep Positive end-expiratory pressure, measured value
PEEPi Intrinsic, positive end-expiratory pressure, measured value
RCexp Expiratory time constant, measured value
Vtrap Trapped gas volume in the lungs due to PEEPi, measured value
RSBI Rapid shallow breathing index
MIP Negative inspiratory force generated by the patient during an
expiratory hold manoeuvre (Maximum Inspiratory Pressure),
measured value
P0.1 Occlusion pressure of the P0.1 manoeuvre, measured value
Paw Airway pressure in general, measured value
P/V Tool Manoeuvre to determine the inflection points
Flow Flow in general, measured value
Vol Volume in general, measured value
t Time in general
Rate Respiratory rate, breaths per minute, configured value
RR Respiratory rate, breaths per minute, measured value
F sp. Respiratory rate per minute, spontaneous, measured value

F max Maximum rate, adjustable alarm limit

F min Minimum rate, adjustable alarm limit
F max spont Maximum spontaneous breathing rate, adjustable alarm limit
F min spont Minimum spontaneous breathing rate, adjustable alarm limit
I:E Inspiratory to expiratory time ratio, configured value
Ramp Time between lower and upper BiLevel, configured value
PS ramp Time between PEEP and PS pressure level, configured value
Tinsp Inspiratory time, configured value
I Inspiratory time, configured value
E Expiratory time, configured value
P Inspiratory pause as a percentage of the inspiratory time, config-
ured value
Apnoea Maximum time without inspirations,
adjustable alarm limit
R Resistance of the respiratory system plus the patient, measured
value
C Compliance of the respiratory system plus the patient, measured
value
TV Tidal volume, configured value
Vt max Maximum tidal volume, adjustable alarm limit
Vt min Minimum tidal volume, adjustable alarm limit
Vt-E Expiratory tidal volume, measured value
Vt-I Inspiratory tidal volume, measured value
MV-E Overall expiratory minute volume, measured value
MV max Maximum minute volume, adjustable alarm limit
MV min Minimum minute volume, adjustable alarm limit
MVsp Spontaneous minute volume, measured value
MVsp% Spontaneous minute volume in percent of the overall minute
volume, measured value
I-Flow Inspiratory flow, configured value
Trigg Flow or pressure trigger required for synchronisation of a breath,
configured value
Exp Trigger Trigger option for synchronisation of expiration in pressure-con-
trolled ventilation modes
ByFlow Bias flow, configured value
PS Endflow Criterion for stopping the inspiratory phase of the spontaneous
breathing activity, configured value
Leakage Leakage rate (determined overall leakage in percent), measured
value in table and maximum allowed leakage,

Insp. Hold Duration of the Inspiratory Hold manoeuvre, configured value

Exp. Hold Duration of the Expiratory Hold manoeuvre, configured value
O2 Inspiratory O2 concentration, configured value
O2 max Maximum inspiratory O2 concentration,
O2 min Minimum inspiratory O2 concentration,
etCO2 max Maximum expiratory CO2 concentration,
etCO2 min Minimum expiratory CO2 concentration,
inCO2 max Maximum inspiratory CO2 concentration,
Vol./Paw Loop Volume vs. pressure loop
Flow/Vol. Loop Flow vs. volume loop
Ref. Loop Reference loop
or AC Alternating current
or DC Direct current
Ser. No. Serial number
SW y.zz.x Software revision number
HW y/x Hardware revision number
O2 40 … 90 PSI Inlet O2 gas supply with a pressure range from 40 to 90 PSI
AIR 40 … 90 PSI Inlet AIR gas supply with a pressure range from 40 to 90 PSI


Preparing the system for use | 6
6 Preparing the system for use
6.1 Power supply 62

6.1.1 Mains supply 62
6.1.2 Internal power supply (rechargeable battery) 62
6.2 Gas supply 64
6.3 Switching power on and off 65
6.4 Power-on self-test 65
6.5 System test 66
6.5.2 Performing the system test 68

6 | Preparing the system for use
6.1 Power supply

6.1.1 Mains supply
Connect the ventilator to the mains supply. The power indicator on the front
panel ON switch turns green.
Remark Only use the original power cord.
Set up the ventilator so that it can be easily disconnected from

Remark
the mains supply at any time.
The fan is always switched on whenever the device is connected

Remark to the mains supply (safety precaution because oxygen leakage
may occur).
Do not use the power cord if it is damaged.

Warning
For safety reasons operation with an extension cable and/or a

multiple socket outlet is not permitted.
Warning
To avoid the risk of electric shock, this device must only be con-
nected to a power supply with a protective earth conductor.
Warning
The power cord is protected against accidental disconnection. This retainer clos-
es automatically when the cord is plugged into the power input.
To remove the power cord, first release the red retainer on the device.
6.1.2 Internal power supply (rechargeable battery)

elisa 800 is equipped with an internal power supply which ensures continued op-
eration if the mains supply fails or during intra-hospital patient transports. If the
mains supply fails, a medium-priority alarm is triggered.

The operating time on battery power depends on the number of inserted batter-
ies, on the accessories in use, and on the selected ventilation parameters. Please
refer to chapter "14.2 Supply" for more information.
The integrity and capacity of the internal power supply are monitored and inte-
grated in the alarm management. When the remaining operating time on battery
power is less than 10 minutes, a low-priority alarm will be released (yellow),
which is followed by a high-priority alarm (red) for a battery run time of less than
5 minutes (also refer to chapter "11.3 Alarm messages during operation").
To extend the operating time, the screen brightness is automatically reduced
when the ventilator runs off battery power.
If the device is connected to the mains supply, the battery is automatically charged.
Battery charging does not interfere with an ongoing ventilation

Remark
procedure.
A battery that has not been fully charged is also charged when
Remark the device is switched off but connected to the mains supply. In
this case, the fan in the device is switched on.
Improper handling of the battery can pose a risk to the user and/
or patient!
Warning
Protectg of the bat8 (y )0.7 (against )1.4 (heat,)99.9 ( )]TJ 0oo1otect brheat
Warning

6.5.1 Select patient category

Start by selecting the patient category (L). You can choose between "Adult" and
"Paediatric".
In compliance with the intended use, the current software ver-

Remark sion is designed for the invasive and non-invasive ventilation of
patients with a minimum body weight of 3.0 kg.
C
A
B J
E F
D G H
The choice of the patient category affects the following functions:
• default parameters
• alarm limits
• dynamic behaviour of the ventilation control
Please refer to chapter "A.1 Default parameters" for details on parameters and
limit values.
The patient category can only be changed when the ventilation is stopped and
the "System test" function is activated via "More Functions" and confirmed with
"Enter".
The device performs the power-on self-test and after that, you can select another
patient category. Once the appropriate breathing circuit and components have
been connected, the system test should be carried out. Then, the ventilator can
be operated in the new patient category.

6.5.2 Performing the system test

Set the elisa 800 up with the breathing circuit and all accessories used during
ventilation.
Connect the Y-piece of the ventilation tube to the system test plug on the left of
the device and start the system test.
The system test lasts approx. 45 seconds. The remaining test time is displayed on
the screen.
Open the Y-connector when instructed to do so. The device automatically rec-
ognises when the Y-connector has been opened and continues the system test.
Always open the circuit directly at the Y-connector to avoid an

incorrect evaluation of the expiratory resistance.
Caution
Never carry out a system test if a patient is connected to the

device.
Warning
After a successful system test, a summary of the compliance, resistance, leakage

and nebulizer flow values (A) is displayed.
If a pneumatic nebulizer set was not connected during the system

test, the most recently measured nebulizer flow with the notifi-
Remark
cation "last value" is displayed. The values for the nebulizer flow
depend on the type of nebulizer set used.
If a malfunction is identified during the system test, a message with an error code
and further information (A) and short instructions (B) appears. Depending on
the instructions you can either "Acknowledge" (C) the error and continue the
system test, carry out corrections and "Repeat" (J) the system test, or "Switch
OFF device" (G).
All entries must be confirmed with the Enter key (H).
From this screen, you can also access the following functions: (D) Service, (E)
Configuration, and (F) Calibrate touchscreen.
After the system test, the ventilator switches to the standby mode.
In emergencies, when there is no time for the system test, you can skip it ("Skip

system test" (K)). Ventilation can be started within approx. 15 seconds of switch-
ing the device on (i.e., on completion of the power-on self-test) in this case.
A notification will be displayed in the toolbox, indicating that "No test" was car-
ried out. It is strongly recommended to carry out the system test as soon as
possible.
If a system test is skipped, the ventilator will use the measure-

ments of the most recent system test. If the installed accessories
are very different from the components of the last setup, the
Warning ventilation parameters may deviate. This may pose a risk to the
patient!
The compliance and resistance of the connected breathing circuit

are determined during a system test and compensated during
Remark ventilation. If the resistance exceeds 6 mbar/l/s and/or the com-
pliance exceeds 3 l/mbar, the system test is terminated with an
error message.
For a list of all alarm messages during the system test, please refer
Remark
to chapter "11.5 Alarm messages during system test".


Operation | 7
7 Operation
7.1 Standby mode 72
7.1.1 Same patient 72
7.1.2 New patient 73
7.1.3 Default ventilation 73
7.1.4 Start ventilation 75
7.1.5 Favourites 75
7.1.6 More functions 75
7.2 Patient interface configuration 75
7.3 Toolbox function keys 77
7.3.1 Help function 77
7.3.2 Screenshot 77
7.3.3 Freeze curve 78
7.3.4 System test 78
7.3.5 Gas supply 78
7.3.6 Battery information 79
7.3.7 Patient data 79
7.8.3 Trend 79
7.3.9 Extended screen display 83
7.4 Ventilation 83
7.4.1 Set ventilation mode 84
7.4.2 Switch between ventilation modes 84
7.4.3 Set ventilation parameters 86
7.4.4 Alarm limits 87
7.4.5 Drug nebulization 87
7.4.6 Tube compensation 88
7.5 System settings 89
7.5.1 Settings 89
7.5.2 Service 90
7.5.3 Hygiene 91
7.5.4 Locking and unlocking the screen 92
7.5.5 Further buttons 92

7 | Operation
7.1 Standby mode

The entire patient ventilation protocol can be pre-configured and the procedure
started in the standby mode.
A B
D G I
F
E H J
All ventilation-relevant alarms are inactive in the standby mode.

Supply and device alarms are suppressed in the standby mode and
Remark are only displayed as a message with the alarm-pause symbol in
the alarm window. However, these alarm management provisions
do not include the power supply alarms.
7.1.1 Same patient

By selecting "Same Patient" (A), you continue with the previously selected venti-
lation mode including all ventilation parameters and alarm limits.

Operation | 7
7.1.2 New patient

If "New Patient" (B) is selected, the alarm limits, ventilation mode and the venti-
lation parameters are all reset to the elisa 800 default values. The automatically
activated default ventilation mode is the first mode on the tab bar (BiLevel in our
example).
If the default parameters are adapted to the patient condition

Remark prior to starting ventilation (C), these will be reset to the defaults
when "New Patient" (B) is selected.
7.1.3 Default ventilation

With the "Default ventilation" function, parameters will automatically adapt to
the patient's clinical requirements at the beginning of the ventilation session. The
function is available when you confirm the "New patient" selection:

7 | Operation
The settings specified in the configuration menu will be applied:

•• ideal weight calculated on the basis of the body height (after entering the body
height, you will see the measured tidal volume on the patient interface after
a few breaths)
•• actual weight
•• specified target tidal volume in millilitres per kilogram of body weight

The activated ventilation mode is the mode assigned to the first tab during con-
figuration. The following rules apply:
•• for volume-controlled modes: adjustment of the tidal volume based on the
body weight
•• for pressure-controlled modes with volume guarantee: adjustment of the tidal
volume based on the body weight
•• for pressure-controlled modes with analysis function activated at the configu-
ration level: adjustment of Pinsp after a 30-second analysis phase to guarantee
the appropriate tidal volume
•• for pressure-controlled modes with analysis function deactivated at the con-
figuration level: adjustment of Pinsp to a fixed value of 10 mbar
The following options and associated values are additionally available for the initial
adjustment of PEEP, rate, inspiratory time, and O2:
Disease-related Normal ventilation Disease-related hyper-

hypoxia situation capnia
Rate 12 /min 12 /min 16 /min
Tinsp 2.0 s 1.5 s 1.2 s
PEEP 8 mbar 5 mbar 5 mbar
O2 100% 50% 50%
Please review the parameters and alarm limits set with the default
ventilation function.
Warning
When the analysis function is deactivated, the necessary pressure

is not determined. Instead, a fixed delta pressure of 10 mbar will
Warning be applied.

Operation | 7
For paediatric patients the actual weight needs to be entered. No

other options are available in this case.
Warning
7.1.4 Start ventilation

Start the configured ventilation mode by selecting the "Start Ventilation" (C) but-
ton.
All entries must be confirmed with the Enter key (J).
7.1.5 Favourites
Irrespective of the direct selection keys, selected functions can be accessed and
activated from the "Favourites" tab.
7.1.6 More functions

Furthermore, the following functions can be accessed with "More Functions" (I)
in the standby mode.
For further information on "More Functions", please refer to

Remark
chapter "7.5 System settings".
7.2 Patient interface configuration

In the patient interface configuration window, you can select the patient interface
(K) used (options deselected at the configuration level are not available).

7 | Operation
L M N O
These are your options:
L HFOT (nasal CPAP: non-invasive)

M Mask (non-invasive)
N Endotracheal tube (invasive)
O Tracheal tube (invasive)
To be able to switch between invasive and non-invasive ventilation, the ventilation

procedure must be interrupted and the ventilator set to the standby mode (More
Functions, Stop ventilation). Then you can switch to another interface.
In the case of non-invasive ventilation, the displayed expiratory

volume may differ from the actual volume applied due to leakage.
Warning
Use CO2 monitoring for non-invasive ventilation because CO2

rebreathing may occur.
Warning
Furthermore you can directly access the menus of the following applications:
Q Automatic suction routine

R Capnometry main stream or side stream sensor
S Drug nebulization

Operation | 7
Q R S
After input of the patient's weight, the measured tidal volume referred to the
ideal body weight will continuously be displayed (l/kg IBW) during the ventilation
procedure (U).
7.3 Toolbox function keys

The function keys in the toolbox provide quick access to important information
about the elisa 800 operating status.
7.3.1 Help function

View information on ventilation modes and parameters (see chapter "5.3 Help
function").
7.3.2 Screenshot
The Screenshot function allows you to make a copy of the visible items displayed
on the screen in the form of a digital image. A USB flash drive is needed for us-
ing the function. The flash drive is plugged into the USB port on the back of the
monitor. The device will detect the USB flash drive and activate the button. When
the button is pressed, an audible feedback signal confirms that the screenshot has
been made and saved on the flash drive.

Operation | 7
7.3.6 Battery information

Indication of the availability of power sources (one battery or two), capacity of
batteries in percent, and the remaining operating time on the internal power sup-
ply. In the battery information window that you open with the "Battery" button a
battery in use is marked green.
In the first 2 minutes after switching on elisa 800, a minimum

operating time on the internal power supply is indicated. Finally,
Remark
an exact calculation of the remaining time is made on the basis of
the current load.
The remaining time can vary depending on the load.The informa-
Remark
tion is updated in intervals of one minute.
7.3.7 Patient data

Open the patient data menu with the button in the tool box.
In the menu, enter the following data for the patient to be ventilated:
• Height
• Weight
• Age
• Gender
• ½ chest circumference
The half chest circumference needs to be entered only if the ventilator integrated
tomography application will be used. The recommended SensorBelt size is calcu-
lated on the basis of the value entered for the chest circumference. Make sure
that the recommended size matches the size of the attached SensorBelt.
7.8.3 Trend
Touch this button to view the trend data.
elisa 800 stores the ventilator settings, logs changes to the ventilator settings,
saves status information, active alarms and the measured patient parameters. In
normal operation in the adult mode the memory can hold the data for a period
of up to three months.

7 | Operation
When you press the Update button while the trend window is open,
you will update the trend data with the continuously acquired read-
ings.
By default, the tabular trend is displayed with a resolution of one minute. It pre-
sents the following measured values:
• expiratory minute volume (MV e)
• expiratory tidal volume (Vt e)
• respiratory rate (RR)
• peak inspiratory pressure (Peak)
• inspiratory oxygen concentration (O2)
• plateau pressure (Pplateau)
• PEEP
• percentage of the spontaneous minute volume (MV spont.)
You scroll through the measured values by a swiping gesture.The associated
time bar ensures that the parameters corresponding to the point in time
will be displayed:
• Ventilation mode
• Inspiratory oxygen concentration (O2)
• Ramp
• Inspiratory pressure (P insp)
• Inspiratory time (T insp)
• Rate
• Tidal volume (Vt)
• Inspiratory flow (I-Flow)
• Pressure limit (Pmax)
• PEEP

Operation | 7
• Pressure support (PS)

• Trigger
The trend display can be configured for different user requirements. With the
"Config." button, the user activates the following selection fields, each of which
can be configured as needed:
• Resolution
(1, 5, 15, 30 or 60 minutes)
• Measurement data
expiratory minute volume (MV e)
intrinsic PEEP (PEEPi)
expiratory tidal volume (Vt e)
trapped volume (Vtrap)
respiratory rate (RR)
inspiratory tidal volume (Vt i)
peak inspiratory pressure (Peak)
expiratory minute volume for spontaneous breathing (MV spont.)
minimum pressure during the ventilation cycle (Pmin)
inspiratory oxygen concentration (O2)
peak
end-tidal CO2 concentration (etCO2)
leakage in percent (Leakage)
plateau pressure (Pplateau)
resistance
mean ventilation pressure (Pmean)
PEEP

percentage of the spontaneous minute volume (MV spont.)
expiratory time constant (RCexp)
• Parameters
inspiratory oxygen concentration (O2)
ramp
ramp for pressure support (PS Ramp)
inspiratory pressure (P insp)
inspiratory time (T insp)
maximum inspiratory time with pressure support (PS TImax)
expiratory trigger (Exp. Trigger)
PS Endflow
rate
tidal volume (Vt)
inspiratory flow (I-Flow)
byflow
pressure limit (Pmax)
PEEP
pressure support (PS)
trigger
• Alarms
system alarms
ventilation alarms
• Events
parameter changes
status changes
alarms
Instructions for Use elisa 800 | SW 1.05.x | Rev. 10

Operation | 7
To clear the current settings and prepare the system for a new configuration,
press the "View" button, and then press "Reset".
You restore the default device settings with the Default button.
7.3.9 Extended screen display

Pressing this button will display more data windows.
7.4 Ventilation
The availability of the ventilation modes is determined by the software version
and the configuration of your device.
For a description of the different ventilation modes, please refer

Remark
to appendix B "Ventilation modes and parameters".
An apnoea ventilation mode, which completely takes over the patient's ventilation
in case of apnoea, is associated with each ventilation mode.

7 | Operation
7.4.1 Set ventilation mode

The currently selected modes are displayed in the ventilation and apnoea mode
window (A). The ventilation mode is identified by the background colour:
NIV (non-invasive) green
IV (invasive) grey
Apnoea ventilation yellow
Resuscitation (or CPR) mode red
Open the menu for selection of the ventilation mode with the "Ventilation" but-
ton (D). Select one of the preconfigured ventilation modes and adapt the ventila-
tion parameters to the patient's needs (also refer to chapter 7.4.3 "Set ventilation
parameters").
7.4.2 Switch between ventilation modes

To switch between ventilation modes during ventilation, select the "Ventilation"
button (D). Activate the new ventilation mode in the ventilation mode bar (G),
then press the "Change Mode: manual" button (E) or "Change Mode: Assistant"
button, and confirm the change with the Enter key (F).
An assistant is available for switching between volume-controlled and pres-

sure-controlled ventilation modes. On the basis of the measured values, the assis-
tant recommends a pressure or a volume setting.
The plateau pressures measured last, for example, are used to set Pinsp.

Operation | 7
The "Change Mode: Assistant" function is not available when the

Remark current measured values cannot be used as the basis for an auto-
matic switchover. The button is inactive.
During ventilation, the new ventilation mode becomes active with

Remark
the start of the next inspiration.
If the new ventilation mode has more parameters than the pre-
vious mode, these will be displayed on a yellow button. Default
values are activated for these parameters.
Warning Adapt the parameters to the current patient condition!

7 | Operation
7.4.3 Set ventilation parameters

A
E
G
To set the ventilation parameters, open the menu with the "Ventilation" button.
Select the parameter that you would like to change. Adjust the value with the
selector and confirm your entry with the Enter key.
For a description of the different ventilation parameters, please

Remark
refer to appendix B "Ventilation modes and parameters".
Below the parameter buttons, there is a bar graph that shows the
Remark
current value in relation to the adjustment range.
The adjustment ranges of the ventilation parameters can limit

each other and may vary, depending on the situation.
Remark
The selector indicates the parameter which is limiting an adjust-
ment range.
To cancel the entry, press the button of the selected parameter once again or
close the selector with the Alpha key (B).

Operation | 7
7.4.4 Alarm limits

Several alarms with variable alarm limits are available for adequate monitoring of
the patient's ventilation and of the ventilator. The alarm limits must be regularly
checked and adapted to the patient's condition if necessary.
Open the menu with the "Alarms" (C) button. Select the alarm limit that you
would like to change. Change the value with the selector and confirm your entry
with the Enter key (F).
To cancel the entry, press the button of the selected parameter once again or
close the selector with the Alpha key (B).
For a description of the different alarm limits, please refer to

Remark
appendix B "Ventilation modes and parameters".
7.4.5 Drug nebulization

or the mesh nebulizer.
Both drug nebulization methods are available for each selected patient category
and in each ventilation mode.
For a detailed description of the nebulizer application, please re-

Remark
fer to appendix C "Drug nebulization".
The use of an externally driven nebulizer can affect the accuracy

of the ventilator.
Warning
If the compensation values are high, the activation of expiratory

Remark compensation can lead to auto-triggering of the pressure sup-
port. In this case, a higher trigger sensitivity should be selected.
Visible overshoots and undershoots are not transferred to the

Remark
patient via the tube.

7 | Operation
7.4.6 Tube compensation

elisa 800 offers a tube compensation feature which can be activated to reduce the
increased tube-related work of breathing of the spontaneously breathing patient.
Tube compensation is adjustable by entering the tube size, by the degree of com-
pensation and by switching the expiratory tube compensation on or off.
Tube compensation reduces the tube-related work of breathing during sponta-

neous breathing by compensating the inspiratory and (alternatively) expiratory
resistance.
Tube compensation can be adjusted in the "Patient interface" menu.
Tube compensation is deactivated and cannot be accessed when

Remark
mask ventilation is selected.
Set the desired degree of compensation in percent and the internal diameter of
the tube in millimetres.
The tube diameter must always be set to the size of the tube
used. A tube diameter that is too small can lead to overcompen-
Warning sation and oscillation during ventilation.
The internal diameter is printed on the outside of the tube or its

Remark
packaging.
Inspiratory or expiratory tube compensation can be activated once the degree of

compensation and tube diameter have been set.
When the compensation function is activated, the calculated tracheal pressure is

superimposed on the pressure curve acquired at the Y-connector before the tube.
If the compensation values are high, the activation of expiratory

Remark compensation can lead to auto-triggering of the pressure sup-
port. In this case, a higher trigger sensitivity should be selected.

Operation | 7
Visible overshoots and undershoots are not transferred to the

Remark
patient via the tube.
7.5 System settings

System settings are performed in the "More Functions" menu. The options availa-
ble in the menu depend on the selected ventilator mode.
7.5.1 Settings
The Settings menu is available in the system test screen, in the standby mode and
during ventilation.
To change a setting, touch the appropriate button, set the new value with the
selector, and confirm the new value with the Enter key.
Date/Time
Setting date and time. This function is not available during ventilation when the
field is dimmed.
Display
Setting display brightness.
Two brightness levels can be preset with the selector: a maximum and a minimum
brightness. By selecting the day or night mode you activate the corresponding
brightness level.
If an alarm occurs, the display brightness is automatically set to 100% for medium
priority alarms and above.

7 | Operation
Alarms
Setting the brightness of the alarm indicators and the alarm volume.
Alarm volume: during normal operation (no alarms), elisa 800 continuously meas-
ures the ambient noise level. When the ambient noise is very loud and an alarm
occurs, the volume of the alarm tone is automatically adapted to the ambient
noise level (Auto Volume ON). The maximum value is 20% above the set value in
this case, but not more than 100%.
However, the volume of the alarm tone will never drop below the preset value
(80% is the default value).
When you adjust the alarm tone volume, the ventilator will emit a tone with the
actual volume so that a volume suitable for the environment can be selected.
The alarm tone volume must allow the user to distinguish be-
tween alarm tones and the background noise.
Warning
7.5.2 Service
The service menu is available in the system test screen and in the standby mode.
It is only intended for authorised service technicians and secured with an access
code.

Operation | 7
7.5.3 Hygiene
To view the remaining time of use or confirm the replacement of an accessory,

select the "More Functions" button to access the hygiene management function.
Components which were set to OFF at the configuration level are not visible in
this screen.
When the period of service of an accessory has expired, the alarm window will
display a message. The change of an accessory is also documented in the trend
data.
Selecting a new patient in the standby mode will set all accessories to the
"changed" status.

7 | Operation
7.5.4 Locking and unlocking the screen

You can "Lock screen" in order to prevent unintentional entries. To unlock the
screen you must hold down the "Unlock screen" button and confirm with the
Enter key.
7.5.5 Further buttons

Further buttons to control the intensive care ventilator in the "More Functions"
menu:
• Start system test
• Stop ventilation
• Switch OFF Device
The "More Functions" menu can also be opened with the ON

Remark
switch.

Manoeuvres | 8
8 Manoeuvres
8.1 Automatic Suction Routine (ASR) 94

8.1.1 Suction with open suction systems 94
8.1.2 Suction with closed suction systems 96
8.1.3 Suction with semi-closed suction systems 97
8.2 P0.1 97
8.3 HOLD manoeuvre 98
8.3.1 Inspiratory Hold (Insp. Hold) 98
8.3.2 Expiratory Hold (Exp. Hold) 98
8.3.3 Manual breath 98
8.4 Maximum inspiratory pressure (MIP) 99
8.6 Sigh function 100
8.6.1 Inspiratory sigh 101
8.6.2 Expiratory sigh 102

8 | Manoeuvres
8.1 Automatic Suction Routine (ASR)
elisa 800 offers a number of manoeuvres to accompany bronchial aspiration with

different suction systems. Depending on the configuration, you can choose from
the following manoeuvres (see chapter "5.2 Configuration"):
8.1.1 Suction with open suction systems

Preoxygenation Suctioning Postoxygenation
2:00 min 2:00 min 2:00 min
Once the suction routine has been started, it can be terminated during any phase
and at any time by pressing and confirming the "Stop" function key.
Preoxygenation phase
The user can change the default O2 concentration value to any desired O2 value.
The set O2 concentration is stored and automatically adopted when the ASR ma-
noeuvre is accessed again. This applies until a new system test is carried out and
the default value is set again.
Once the preoxygenation phase has been started, the remaining time is displayed
by a count-down timer in the form of a bar chart.
The preoxygenation phase can be terminated at any time with the "Stop" function

Manoeuvres | 8
key or the suction phase can be started prematurely via the "Suction" function key.
If the breathing circuit is opened during the preoxygenation

Remark phase, elisa 800 switches to the suction phase after detecting the
open circuit.
Suction phase
Upon completion of the preoxygenation phase, the ventilator sends a short
acoustic signal and switches to the suction phase.
The remaining time of the suction phase is displayed by a count-down timer in

the form of a bar chart. The gas supply valves are closed and the expiratory valve
is opened at the start of the suction phase. Thus, the pressure in the breathing
circuit is relieved and the patient tube connection can be opened without any risk
for contamination.
All patient alarms are deactivated once the breathing circuit has
been opened. A short acoustic signal is repeated every 10 sec-
Warning onds to remind the user that ventilation is not active.
The inspiratory flow and the expiratory valve are reconnected 10 seconds after
starting the suction phase.

8 | Manoeuvres
Postoxygenation phase
If a closed tubing system is detected, the suction phase is terminated and ven-
tilation in the postoxygenation phase is started. Ventilation will also start if the
patient is still not disconnected after 10 seconds.
Alternatively, the ventilator switches to the postoxygenation phase once the suc-
tion phase has been completed and starts ventilation. If this is not possible be-
cause the breathing circuit is still open, a corresponding alarm is triggered.
Once ventilation is resumed, the ventilation parameters and alarm limits of the
preoxygenation phase are used. Even a modified O2 value is maintained but it can
be changed at any time.
The postoxygenation phase is terminated after 2 minutes. The O2 value is auto-

matically reset to the value which was set prior to starting the automatic suction
routine. The automatic suction routine switches off automatically.
8.1.2 Suction with closed suction systems

Preoxygenation Suctioning Postoxygenation
2:00 min 2:00 min 2:00 min
The suction routines for open and closed suction systems are almost identical.
Since the ventilation system is still connected, ventilation is not interrupted and
the user has to indicate the different phases of the suction routine (preoxygena-
tion, suction and postoxygenation) to the device by pressing the respective keys.
The BiLevel ventilation mode should be selected for suction with

Remark closed suction systems because negative pressures may occur or
control algorithms may be altered in other modes.
8.1.3 Suction with semi-closed suction systems

Suctioning
2:00 min
With this suction routine, the set oxygen concentration is applied for 120 seconds
as complementary oxygenation, during which the audible alarms are disabled.

Manoeuvres | 8
8.2 P0.1
P0.1 occlusion pressure identifies the negative value which is established in the
first 100 milliseconds (0.1 s) of an inspiration phase (with closed valves) and rep-
resents a measure for the neuromuscular respiratory drive of the spontaneously
breathing patient.
The values in a patient with healthy lungs who is breathing calmly are up to -3 and
-4 mbar.Values greater than -6 mbar indicate imminent respiratory fatigue.
The manoeuvre can be started in all ventilation modes. The only condition is the
patient being able to reach the trigger value.
The manoeuvre can be activated as a manual single measurement or for regular
monitoring at defined intervals. After the manoeuvre, the respective measured
value is displayed in the measurement value table of the extended screen display
and in the trend graph in the P0.1 menu.

8 | Manoeuvres
8.3 HOLD manoeuvre

8.3.1 Inspiratory Hold (Insp. Hold)
The inspiratory hold manoeuvre is a function to perform an inspiratory hold of
up to 30 seconds at the end of the mandatory inspiration phase. Set the desired
hold time and finally start the manoeuvre. The remaining time of the manoeuvre
is displayed in a bar chart. The manoeuvre can be terminated prematurely at any
time.
Please note that the inspiratory hold manoeuvre will be aborted when the set
maximum tidal volume VT max is reached. This means that the time can be con-
siderably shorter.
Remark After a manoeuvre, the function is blocked for 15 seconds.
8.3.2 Expiratory Hold (Exp. Hold)

The expiratory hold manoeuvre is a function to perform an expiratory hold of up
to 20 seconds at the end of the mandatory expiration phase. The intrinsic PEEP
(PEEPi), trapping volume (Vtrap) and the Maximum Inspiratory Pressure (MIP)
value are determined during the manoeuvre. The measured values are presented
on the extended screen display.
Set the desired hold time and finally start the manoeuvre. The remaining time
of the manoeuvre is displayed in a bar chart. The manoeuvre can be terminated
prematurely at any time.
Remark After a manoeuvre, the function is blocked for 15 seconds.
8.3.3 Manual breath

The "Manual breath" manoeuvre is a function used to deliver a single machine
breath immediately upon activation.
With each activation of the Enter button the patient receives a manual breath,
similar to ventilation with a manual resuscitation bag.

Manoeuvres | 8
8.4 Maximum inspiratory pressure (MIP)

The maximum inspiratory pressure corresponds to the negative inspiratory force
that the patient can exert.The negative value is determined during the expiratory
hold manoeuvre and terminates it. The measured value is presented on the ex-
tended screen display.
8.5 O2 Flush
Selecting and confirming the O2 Flush button will briefly increase the inspiratory
oxygen concentration to 100% for 180 seconds. After this period or when the
Cancel button is pressed, ventilation continues with the previously set oxygen
concentration.

8 | Manoeuvres
8.6 Sigh function

The Sigh function regularly applies breaths with increased PEEP, pressure, or vol-
ume that are intended to ventilate little-used regions of the lung. The deeper
breaths are intended to prevent atelectasis and protect unventilated regions of
the lung from collapsing. The user can define the frequency, number of breaths
with activated sigh function, and level of increase.
The function and its mode of operation (inspiratory or expiratory sigh) are de-
fined at the configuration level.
If both sigh modes are enabled in the configuration menu, either the inspiratory
sigh or the expiratory sigh can be selected. The expiratory sigh function is acti-
vated in our example.
A message indicates the onset of the sigh function.

Manoeuvres | 8
8.6.1 Inspiratory sigh

With the inspiratory sigh function, the machine delivered breaths are intensified
regularly as follows:
•• in volume-controlled or pressure-controlled modes: by increasing the tidal
volume by the set factor
•• in pressure-controlled modes: by increasing the inspiratory pressure (Pinsp)
by the set factor
The user can define the following settings:

•• Interval: Number of breaths between two sigh phases
•• Cycle: Number of breaths with activated sigh function
•• Factor: Multiplier by which the tidal volume or Pinsp. is to increase

8 | Manoeuvres
8.6.2 Expiratory sigh

With the expiratory sigh function, the machine delivered breaths are intensified
regularly by increasing the PEEP by the set factor.
The user can define the following settings:
•• Interval: Number of breaths with activated sigh function
•• Cycle: Number of breaths with activated sigh function
•• Factor: Multiplier by which PEEP is to increase
In order to prevent volutraumas and barotraumas, the set alarm limits remain
active during delivery of breaths with activated sigh function.

Measurements and graphics | 9
9 Measurements and graphics
9.1 Curve display 104

9.2 Instant View window 104
9.3 Weaning window 106
9.4 Loop window 106
9.5 Data Table window 108

9 | Measurements and graphics
9.1 Curve display

The conventional curve display shows pressure, flow, and volume over time. The
time axis is fixed at 15 seconds.
All trigger points reached are identified by green marks.
If tube compensation is active, the calculated tracheal pressure is

Remark superimposed as a black line on the grey pressure curve meas-
ured at the Y-connector in front of the tube.
9.2 Instant View window

The following measurement values and the corre-
sponding alarm limits are displayed in the Instant
View window:
• Expiratory minute volume: MVe

• Expiratory tidal volume:VTe
• Peak pressure of the last breath: PEAK
• Positive end-expiratory pressure: PEEP
• Respiratory rate: F
• Oxygen concentration: O2

• End-expiratory CO2 concentration: etCO2
Colour codes highlight measurement values and indicate their status with respect
to the defined alarm limits, while there is no need to read off the exact measure-
ment value.
If a measurement value reaches or exceeds an alarm limit, the display field of the
measurement value turns red and the appropriate alarm is triggered. A measure-
ment value getting close to a defined alarm limit is identified by a yellow display
field. The threshold values of the individual alarm limits are summarised in the
following table:
Adult patients Paediatric patients

≤ lower limit ≥ upper limit ≤ lower limit ≥ upper limit
MVe + 500 ml - 500 ml + 50 ml - 50 ml
VTe + 50 ml - 50 ml + 5 ml - 5 ml
PEAK + 2 mbar - 2 mbar + 1 mbar - 1 mbar
PEEP + 2 mbar - 2 mbar + 1 mbar - 1 mbar
F + 5 /min - 1 /min + 5 /min - 1 /min
etCO2 + 2 mmHg - 2 mmHg + 2 mmHg - 2 mmHg
Remark A threshold range for oxygen concentration is not available.
In addition to the measurement values, a bar chart shows the ratio of the sponta-
neous to the mandatory breathing portions in graphical form. In the graphic, the
spontaneous part is shown in green and the mandatory part in white.

9.3 Weaning window

Important measurement values and indexes can be easily monitored in the Wean-
ing window. The values determined are displayed as follows:
Red Yellow Green Yellow Red

RSBI - - ≤ 105 106 to 109 ≥ 110
P0.1 ≤ -6 -5 to -4 ≥ -3 - -
MIP ≤ 15 16 to 19 ≥ 20 - -
VT sp. ≤ 249 250 to 299 300 to 550 551 to 599 ≥ 600
F sp. ≤7 8 to 10 11 to 30 31 to 34 ≥ 35
etCO2 < 25 25 to 30 31 to 45 46 to 50 ≥ 51
9.4 Loop window

Open the extended screen display to see the loop view. This view shows the fol-
lowing ratios in graphical from: pressure - volume, volume - CO2, volume - flow,
flow - pressure, and flow - tracheal pressure.
The loop of the current breath is a black line, the loop of the previous breath is a
grey area. The scales of the loop view adapt automatically.
When you touch the loop on the extended screen display, the associated menu
opens and a loop is shown in a larger format. To facilitate the evaluation, the loop
can be started and stopped with the Start and Stop keys.

On the Reference tab, up to ten reference loops can be saved with the corre-
sponding times:
• First select the key to which you want to assign the loop.
• The selected key turns green when touched.
• Touch the Save key and then touch Enter to save the reference loop; the date
and time will be displayed in the designated key.
• When you touch the designated key again, the stored reference loop will be
shown as a green area under the current loop.
You can overwrite stored reference loops by selecting the corresponding key and
saving another loop.
The stored reference loops will be deleted when you select a new patient.

9.5 Data Table window

In the extended screen display, the following measurement values are available in
all ventilation modes in the Data Table window:
• Mean pressure value of a breath: Pmean

• Determined leakage rate: Leakage
• Volume trapped in the lungs (due to intrinsic PEEP) Vtrap
• Intrinsic positive end-expiratory pressure PEEPi
• Occlusion pressure of the P0.1 manoeuvre: P0.1
When you touch the Data Table window, the display is expanded by the following
measurement values:
• Spontaneous minute volume: MV spont.

• Portion of spontaneous MV in the overall MV: MV spont. %
• Rapid Shallow Breathing Index: RSBI
• Maximum inspiratory pressure: MIP
• Expiratory time constant: RCexp
• Compliance of the whole respiratory system: Compliance
• Resistance of the whole respiratory system: Resistance
• Inspiratory applied tidal volume:VT i
• SPO2 (the function will be available in a later software version)
• Inspiratory CO2 concentration: inCO2
Touching the Data Table window on the extended screen display once again hides
the additionally displayed measurement values.
The expiratory time constant is a measure of the complete ex-

piration while avoiding an auto-PEEP situation. For this measure-
ment, the expiratory flow is determined at 75% of the expiratory
vital volume and the necessary expiration time is calculated.
The following standard values are applicable for the necessary

Remark
expiration time:
1 x RCexp 63%
2 x RCexp 86.5%
3 x RCexp 95%
4 x RCexp 98%

Monitoring | 10
10 Monitoring
10.1 Oxygen measurement (O2) 110

10.2 Capnometry (CO2) 110
10.3 VIT - Ventilator-integrated tomography 111

10 | Monitoring
10.1 Oxygen measurement (O2)

A paramagnetic O2 sensor without consumables is used to monitor the inspir-
atory oxygen concentration. The sensor is calibrated by the authorised service
technician as part of the annual maintenance procedure.
When using oxygen concentrators or when the oxygen concen-

tration from the central gas supply is insufficient, the sensor cali-
Warning bration may not be correct.
The paramagnetic oxygen sensor has an automatic compensation

Remark
for the barometric pressure.
Measurement accuracy of the O2 value:

Remark
2.5% volume per cent + 2.5% gas concentration
Long-term drift of the O2 measurement values:

Remark
0.4% in the first month and 0.2% for each additional month
10.2 Capnometry (CO2)

elisa 800 can be used in combination with approved main and side stream sensors
to measure CO2. Integrate the CO2 sensor as described in chapter 4.8 and con-
nect it to the serial interface of the ventilator using the connection cable.
Measuring accuracy of the CO2 value (according to manufactur-

Remark er's specifications):
0.3% volume per cent + 4% gas concentration

Monitoring | 10
Open the menu for configuration of the CO2 sensor by pressing the CO2 icon (A)
in the patient configuration area.The device automatically detects the sensor type:
main stream or side stream. Set the number of breaths for averaging of the etCO2
value. Start the measurement of the CO2 sensor by selecting the "On" button and
confirm with the Enter key.
Calibration with ambient air is recommended before use. To do so connect the

side stream sensor with the measuring line or place the main stream sensor on
the measuring cuvette.
After a warm-up phase of 15 seconds, the "Zero Adjust" button in the "CO2 Sen-
sor" menu will be enabled and the sensor can be zeroed.
Disconnect the patient from the ventilator while the sensor is

Remark
being zeroed.
After the zero adjustment, the CO2 measurement is performed continuously and
the result is displayed in the Instant View window.
In the current software version, the end-tidal CO2 concentration

Remark
is only displayed as a numeric value in mmHg.
The CO2 measurement can be terminated by switching off the CO2 sensor in the
appropriate menu.
10.3 VIT - Ventilator-integrated tomography

Ventilation-associated complications can be made visible on intensive care venti-
lators with the help of non-invasive lung monitoring.
For a detailed description of the ventilator-integrated tomogra-

Remark
phy feature, please refer to the "VIT" module handbook.

10 | Monitoring

Alarms and troubleshooting | 11
11 Alarms and troubleshooting
11.1 Alarm system 114

11.1.1 Alarm pause 115
11.2 Alarm priorities 116
11.3 Alarm messages during operation 116
11.4 Alarm messages during power-on self-test 132
11.5 Alarm messages during system test 135

11 | Alarms and troubleshooting
11.1 Alarm system

The intensive care ventilator is equipped with alarms to support patient safety.
The system classifies the alarms in 7 different priority levels which can also esca-
late and de-escalate.
Alarm messages are shown in the alarm window and sorted according to activity,
priority and time of occurrence. If more than 4 alarms occur at the same time, the
4 alarm messages with the greatest importance will be shown.
The acoustic and visual alarms are always those of the active alarm with the high-
est priority.
An additional window containing information on the cause and possible correc-

tive measures is opened by touching the displayed alarm message in the alarm
window. If an alarm becomes inactive, the acoustic and visual alarms are also deac-
tivated. The alarm message remains visible in the alarm window for informational
purposes until it is acknowledged with the alarm pause key (A).
The ventilator logs all alarms that occur, and authorised service
Remark
technicians can access this alarm log even after a device failure.
If the storage capacity of the internal memory is exhausted, the

Remark
oldest data of the alarm history is overwritten.
The set alarm limits are stored in a non-volatile memory and

Remark can be accessed at any time after switching on the ventilator and
selecting "Same patient". This also applies after a power failure.
At the beginning of the ventilation procedure, audible alarms are

disabled for 120 seconds. During this period, ventilator settings
can be adjusted without annoying alarms, and the first measure-
Remark
ments can be performed.
This measure is intended to reduce the number of unnecessary
alarms and the associated stress.

11.1.1 Alarm pause

An alarm can be suppressed for a maximum of 2 minutes. Pressing the alarm pause
key (A) deactivates the acoustic and visual alarms.The alarm message remains vis-
ible in the alarm window and an alarm pause symbol is additionally shown. The
remaining alarm suppression time is displayed in the alarm pause key (B).
New alarms occurring during an alarm pause will trigger a new

Remark
alarm!
During absence of alarms, all alarms can be suppressed in advance

Remark
(C) for 2 minutes.
A B C

11.2 Alarm priorities

The different alarm priorities are displayed in different forms:
Alarm priority Alarm text Alarm light Alarm sound

Blue on a white back-
1 - information OFF OFF
ground
Blue on a yellow back-
2 - low priority Yellow ON
ground
Blue on a yellow back-
3 - low priority Yellow ON
ground
Black on a yellow back-
4 - medium priority Yellow flashing ON
ground
Black on a yellow back-
5 - medium priority Yellow flashing ON
ground
White on a red back- Red
6 - high priority ON
ground flashing
White on a red back-
7 - high priority ground (flashing in reverse Red flashing ON
video)
Remark Alarm priority 1 is purely advisory, no risk potential.
11.3 Alarm messages during operation

In the following tables, you will find an overview of the different alarm messag-
es, their error codes, priorities, causes with delay times and possible corrective
measures.
Remark Please note down the displayed error codes for service purposes.
The alarm messages are sorted numerically in ascending order.

Patient alarms
Code Priority Alarm Cause Corrective measure

message
- Check patient condition and
breathing pattern
Expiratory Minute - Rule out auto triggering
6
#101 MV high Volume > Upper - Remove condensation from
7
Alarm Limit breathing circuit
- Consider adjusting alarm limits
or ventilator settings
breathing pattern
- Check breathing circuit, tube
connector and humidifier for
Expiratory Minute
6 leaks
#102 MV low Volume < Lower
7 - Rule out insufficient blocking of
Alarm Limit
the tube
- Check correct assembly of
breathing circuit
Tidal volume - Check patient condition and
> Upper Alarm breathing pattern
6 Limit - Consider changing ventilation
#103 VT high
7 mode or adjusting ventilator
Delay: settings
2 breaths max. - Consider adjusting alarm limits
breathing pattern
Tidal volume - Check breathing circuit, tube
< Lower Alarm connector and humidifier for
6 Limit
#104 VT low leaks
7
- Check correct mask position
Delay:
2 breaths max. - Check correct assembly of
breathing circuit
breathing pattern
Leakage connector and humidifier for
#105 2 Leakage high > Upper Alarm leaks
Limit - Check correct mask position
breathing circuit


message
breathing pattern
leaks
High leakage,
- Check correct mask position
#106 7 Leakage high beyond compen-
sation
breathing circuit
If the above measures do not
correct the problem, replace
device and immediately continue
ventilation with another ventilator
Respiratory Rate breathing pattern
> Upper Alarm - Rule out auto triggering
Limit - Remove condensation from
#107 4 Rate high breathing circuit
Delay: - Consider adjusting alarm limits
2 breaths or 5 sec- or ventilator settings
onds max. - Consider reviewing sedation
protocol
Respiratory Rate - Check patient condition and
< Lower Alarm breathing pattern
4 Limit - Consider adjusting alarm limits
#108 Rate low
6 or ventilator settings
Delay:
2 breaths or 5 sec-
- Consider reviewing sedation
onds max. protocol

breathing pattern
Apnoea venti- Apnoea ventilation - Consider changing ventilation
#109 7
lation is enabled mode or adjusting ventilator
settings
breathing pattern
- Consider changing ventilation
#110 7 Apnoea Apnoea
mode or adjusting ventilator
settings
breathing pattern
Airway Pressure - Check breathing circuit, tube
> PLimit connector and tube for kinks
Airway pressure
#111 6 - Rule out that patient is fighting
high
Cancellation of the ventilator
breath initiated - Consider reviewing sedation
protocol


message
breathing pattern
Airway Pressure
> 2 mbar above
connector and tube for kinks
Airway pressure PLimit
#112 7 - Rule out that patient is fighting
high
the ventilator
Safety valve
opened
protocol
breathing pattern
connector and tube for kinks
- Rule out that patient is fighting
1
Airway pressure PLimit will limit the the ventilator
#113 2
high current breath - Consider reviewing sedation
4
protocol
- Check correct tube placement
- Consider performing bronchial
toilet
Airway Pressure breathing pattern
> 20 mbar above - Check breathing circuit, tube
Pmax or > 10 connector and tube for kinks
Airway pressure
#114 7 mbar above PLimit - Rule out that patient is fighting
high
the ventilator
Safety valve - Consider reviewing sedation
opened protocol
breathing pattern
Airway pressure
Airway pressure leaks
#115 4 < Lower Alarm
low - Rule out insufficient blocking of
Limit
the tube
breathing circuit
Pmean > Upper - Check patient condition and
Mean airway Alarm Limit breathing pattern
#116 4
pressure high - Consider adjusting alarm limits
Delay:
2 breaths max. or ventilator settings
Pmean < Lower - Check patient condition and

Mean airway Alarm Limit breathing pattern
#117 4
pressure low - Consider adjusting alarm limits
Delay:
2 breaths max. or ventilator settings


message
breathing pattern
PEEP > Upper - Check expiratory limb of
Alarm Limit breathing circuit including acces-
#118 7 PEEP high
sories for kinks
Delay:
2 breaths max. Check expiratory flow sensor for
defects, contamination and humid-
ity and replace if needed
breathing pattern
PEEP < Lower - Check breathing circuit, tube
Alarm Limit connector and humidifier for
#119 7 PEEP low leaks
Delay: - Rule out insufficient blocking of
2 breaths max. the tube
breathing circuit
O2 > Upper Alarm
Limit
#120 5 O2 high
Delay: - Calibrate oxygen sensor
15 seconds max. - Check O2 concentrator if
required
O2 < Lower Alarm - Check O2 delivery setting at O2
5 Limit concentrator if required
#121 O2 low
7
Delay:
15 seconds max.

breathing pattern
etCO2 > Upper - Check respiratory minute vol-
#122 4 etCO2 high ume, tidal volume and respiratory
Alarm Limit
rate
- Investigate for additional dead
space due to accessories
- Rule out contamination of CO2
cuvette
etCO2 < Lower - Consider performing a CO2
#123 4 etCO2 low zero adjustment
Alarm Limit
- Rule out CO2 rebreathing

- Check central gas supply or
inCO2 > Alarm compressor
#124 4 inCO2 high
Limit - Assess risk potential and consid-
er contacting authorised service
agent or adjusting alarm limits


message
1 Airway pressure PAW < -1cmH2O, - Contact authorised service
#131
4 negative (multiple breaths) agent
PAW < -1cmH2O,
Airway pressure - Contact authorised service
#132 7 (5 seconds or
negative agent
more)
breathing pattern
Airway pressure connector and tube for kinks
1 Pressure limi-
#133 ≥ ventilation pa- - Rule out that patient is fighting
2 tation
rameter Pmax the ventilator
protocol
High Leakage or
Tube Disconnected - Check correct assembly of
#134 7 Disconnection
breathing circuit
Delay:
15 seconds max.
breathing pattern
- Rule out occlusion in tube and
breathing circuit
Unable to apply - Check mask if required
adequate volume - Consider performing bronchial
#135 7 Tube blocked toilet
Delay: - Rule out that patient is fighting
2 breaths max. the ventilator
protocol
Set alarm limit - Adapt O2 alarm settings
#136 1 O2 alarm limits? greater than 5% or - Consider alternative FiO2 meas-
alarm system OFF urement method
- Volume measurement not
Expiratory
possible
measurement
- No trigger detection possible
impossible because
Expiratory - No leak compensation possible
#137 7 expiratory flow
sensor? - No tube compensation possible
sensor missing
- Check expiratory flow sensor
or measurement
- Replace expiratory flow sensor
error
if required
Suction routine
- To terminate suction, press
#138 5 Closed suction for closed suction
Post-oxygen. or Stop
system activated


message
Suction routine
- To terminate suction, re-connect
#139 5 Open suction for open suction
patient
systems activated
Ventilator Unit Alarms
Code Priority Alarm message Cause Corrective measure

- Safe operation cannot be guar-
anteed
- Disconnect patient from
#201 3 Pressure, flow or device and immediately continue
to and/or voltage measure- Sensor problem ventilation therapy with another
#269 7 ment error ventilator
- Immediately remove ventilator
from service
- Contact authorised service agent
If a sensor problem occurs, the ventilator must be immediately

removed from service! Note down the alarm code and contact
Warning an authorised service agent
Control Unit Alarms
No. Priority Alarm message Cause Corrective measure

Control unit - Control unit will restart auto-
#301
matically
to 3 Control unit
Delay: - if alarm persists, contact author-
#303 5 seconds max. ised service agent
- Automatic brightness control
by ambient light sensor may be
disabled
#304
Left/Right Light - No effect on ventilator function
and 1 Light sensor
Sensor Failure - Adjust brightness of control unit
#305
manually if needed
- if alarm persists, contact author-
ised service agent
- Temperature sensor for fan
Control Unit Tem- regulation in control unit may be
perature Sensor defective
Temperature Failure - Fan in control unit operates at
#306 3
sensor maximum power
Delay: - No effect on ventilator function
1 minute max. - if alarm persists, contact author-
ised service agent


message
- Check ambient temperature
- Ensure unobstructed space
around control unit for heat
Control Unit Tem- dissipation
perature Outside - Displayed information may be
Temperature Operating Range reduced due to impaired comput-
#307 3
sensor ing capacity of the control unit
Delay: - If temperature continues to rise,
1 minute max. a forced shut-down of the control
unit may occur
ised service agent
- Displayed information may be
reduced due to impaired comput-
Fan Sensor Defect ing capacity of the control unit
or Fan Failure - If temperature continues to rise,
#308 3 Fan failure
a forced shut-down of the control
Delay:
30 seconds max. unit may occur
ised service agent
- Alarm condition will be signalled
by buzzer in ventilator unit
Control Unit
Loudspeaker - Disconnect, then reconnect
#309 3 Loudspeaker Error
error control unit
(Main Alarm)
ised service agent
- Automatic volume control
disabled
- No effect on ventilator function
Automatic Volume
#310 3 Volume control - Adjust volume manually if
Control Error
needed
ised service agent
- Alarm condition will be signalled
Control Unit by alarm lights on ventilator unit
#311 3 Alarm light
Alarm Light Failure - if alarm persists, contact author-
ised service agent
Control Unit
#312 - Replace control unit
Backlight Error /
to 3 Power failure - if alarm persists, contact author-
Control Unit Pow-
#317 ised service agent
er Supply Error

Power Management Alarms

message
Communication anteed
error between - Disconnect patient from
ventilator unit device and immediately continue
and mains power ventilation therapy with another
#401 7 Battery
supply ventilator
Delay: from service
15 seconds max. - if alarm persists, contact author-
ised service agent
Mains Power - Restore mains power supply
Supply Failure - Check power cord
#402 2 Mains failure - Check power supply
Delay: - Consider contacting an author-
15 seconds max. ised service agent
No Battery - Safe operation cannot be guar-
Available anteed
#403 7 No battery
- Insert battery immediately or
Delay:
15 seconds max. remove ventilator from service
Lower / Upper
#404 Battery Defect - Replace lower / upper battery
and 2 Battery - Consider contacting an author-
#405 Delay: ised service agent
15 seconds max.
- Ventilation is ensured
Battery Overload - Additional functions be may
#406 2 Battery overload disabled
Delay:
ised service agent
AC Adapter - Ventilation is ensured
Overload - Additional functions be may
AC adapter
#407 2 disabled
overload Delay: - if alarm persists, contact author-
1
Lower / Upper - Remaining usage time on battery
2
#408 Battery Low power is less than 10 minutes
3
and Battery - Restore mains power supply or
4
#409 Delay: install additional battery in upper /
6 15 seconds max. lower battery compartment
7
- To prevent overheating inside
the device remove device from
Fan Failure in
#410 5 Fan failure service
Ventilator Unit
ised service agent


message
Communication
error between
ventilator unit and - Switch OFF by disconnecting
mains power sup- mains plug and removing batteries
#411 3 Internal fault ply, device cannot - if alarm persists, contact author-
be switched off ised service agent
Delay:
15 seconds max.
- Charging continues when
Temperature of temperature returns to operating
lower / upper range
#412 battery outside - Check ambient temperature
and 1 Battery operating range - Rule out presence of exter-
#413 during charge cycle nal heat sources causing rise in
temperature
Delay:
15 seconds max. - After transport in cold environ-
ment, allow device to warm up
Lower / upper
battery charging
#414 circuit failure, no - if alarm persists, contact author-
and 1 Battery charging possible ised service agent
#415
Delay:
15 seconds max.
Lower / upper bat-
#416 tery overheated - Replace battery
and 6 Battery - Have authorised service agent
#417 Delay: check removed battery
15 seconds max.
Unable to switch - Safe operation cannot be guar-

to mains power anteed
supply (defect) - Immediately remove ventilator
#418 3 Battery
from service
Delay: - Contact authorised service
15 seconds max. agent
Charging circuit
error - unable to - Remove battery and install in
#419 charge lower / upper / lower battery compart-
and 1 Battery upper battery ment
#420 - if alarm persists, contact author-
Delay: ised service agent
15 seconds max.
Unable to switch - Safe operation during mains

to battery power failure cannot be guaranteed
(defect) - Immediately remove ventilator
#421 7 Battery
from service
Delay: - Contact authorised service
15 seconds max. agent


message
Expiratory Flow - Expiratory measuring values may
Sensor Heating be incorrect
Expiratory flow Error
#501 4 - As a precaution, device should
Sensor
be removed from service
Delay:
30 seconds max. - Contact authorised service
agent
- Rule out presence of exter-
nal heat sources causing rise in
Temperature inside temperature
ventilator unit - After transport in cold environ-
Device temper- deviating from ment, allow device to warm up
#502 5 operating range
ature - Expiratory measuring values may
be incorrect
Delay:
10 seconds max. - As a precaution, device should
- Consider contacting an author-
ised service agent
- Rule out presence of external
heat sources causing rise in tem-
perature
Temperature inside - If connected to air compressor
ventilator unit or oxygen concentrator, check
deviating from temperature of supplied respired
Device temper-
#503 5 operating range gases
ature
- After transport in cold environ-
Delay: ment, allow device to warm up
10 seconds max. - If alarm condition persists,
device should be removed from
service as a precaution
ised service agent
ON switch stuck - Ventilation is ensured
or pressed too - Do not press ON switch longer
#504 4 ON switch error long than 10 seconds
Delay:
- Ventilation is ensured, but visual

indication of alarms may not be
possible
Ventilator unit
#505 3 Alarm light - As a precaution, device should
alarm LED failure
ised service agent


message
- Ventilation is ensured, but audi-
ble indication of alarms may not
be possible
Ventilator unit
#506 7 Buzzer fault - As a precaution, device should
buzzer failure
ised service agent
O2 Measurement - Have paramagnetic O2 sensor
Error calibrated
#507 3 Oxygen sensor
Delay:
anteed
Internal device Sensor Communi-
#508 7 ventilation therapy with another
failure cation Failure
ventilator
from service
- Check all ventilator settings and
Default Configura-
#509 2 Memory error alarm limits, adapt if required
tion Load Error
ised service agent
anteed
Internal device Internal Power
#510 7 ventilation therapy with another
failure Supply Failure
ventilator
from service
- Disconnect CO2 sensor from
CO2 sensor serial interface, then reconnect
reports error - Replace defective CO2 sensor if
CO2 sensor and cannot be applicable
#511 3 activated.
defect - use external CO2 monitoring if
required
Delay:
ised service agent
CO2 adapter
reports error - use external CO2 monitoring if
CO2 sensor and cannot be required
#512 3 activated.
defect - if alarm persists, contact author-
ised service agent
Delay:
30 seconds max.


message
CO2 Sensor Cali-
bration Required - Rule out contamination of CO2
#513 3 CO2 calibration sensor
Delay: - Perform calibration
30 seconds max.
- Disconnect CO2 sensor from
CO2 sensor serial interface, then reconnect
reports error - Replace defective CO2 sensor if
CO2 sensor and cannot be applicable
#514 3 activated.
defect - use external CO2 monitoring if
required
Delay:
ised service agent
Unsafe detection - Rule out leak in breathing circuit
of end-tidal range and measuring line
Invalid CO2 or breath
#515 3 - Watch patient to determine
measurement
pathological breathing patterns
Delay:
30 seconds max. - Check ventilator settings
Mesh Nebulizer Alarms

message
Expiratory Flow - Expiratory measuring values may
Sensor Heating be incorrect
#530 3 Mesh nebulizer Error - As a precaution, device should
Delay:
ised service agent
- Rule out presence of exter-
nal heat sources causing rise in
Temperature inside temperature
ventilator unit - After transport in cold environ-
Device temper- deviating from ment, allow device to warm up
#531 3 operating range
ature - Expiratory measuring values may
be incorrect
Delay:
30 seconds max. - As a precaution, device should
ised service agent


message
Fill level in inha- - Switch off nebulizer
lation unit below - Check medication level
1 minimum - refill medication solution if
#532 Mesh nebulizer
2 applicable
Delay: - Switch on nebulizer and check
30 seconds max. for proper functioning
Inhalation unit in - Replace defective mesh nebuliz-
mesh nebulizer er if applicable
defective - replace defective connection ca-
#533 3 Mesh nebulizer
ble of mesh nebulizer if applicable
Delay: - if alarm persists, contact author-
No or wrong
inhalation unit
Wrong inhalation connected to mesh
534 3 nebulizer - Connect approved nebulizer unit
unit
Delay:
30 seconds max.

message
- Remove and clean expiratory
Expiratory flow flow sensor
sensor may be - Check measuring cell in expira-
Flow measure- contaminated or tory flow sensor for damage
#650 2 defective
ment error - Replace expiratory flow sensor
if required
Delay:
30 seconds max. - If alarm persists,
contact service agent
- Check gas wall outlet
- Open pressure relief valve at
oxygen cylinder if applicable
- Replace oxygen cylinder if
3 Low oxygen inlet
#654 O2 supply required
7 pressure
- Check gas supply hoses for leaks
if applicable
- If alarm persists,


message
anteed
3 High oxygen inlet
#655 O2 supply ventilation therapy with another
7 pressure
ventilator
from service
- Contact service agent
- Open pressure relief valve
at compressed air cylinder if
applicable
3 Low air inlet - Replace compressed air cylinder
#656 Air supply
7 pressure if required
if applicable
- If alarm persists, contact service
agent
anteed
3 High air inlet
#657 Air supply ventilation therapy with another
7 pressure
ventilator
from service
- Open pressure relief valve at
pressure cylinder if applicable
- Replace pressure cylinder if
3 Low 3rd gas supply
#658 3rd gas supply required
7 pressure
if applicable
- If alarm persists,
anteed
3 High 3rd gas sup-
#659 3rd gas supply ventilation therapy with another
7 ply pressure
ventilator
from service


message
anteed
#660 device and immediately continue
Controller Failure
to 7 Internal fault ventilation therapy with another
in Ventilator Unit
#665 ventilator
from service
anteed
#666 7 Internal error Internal safety fault ventilation therapy with another
ventilator
from service
- To terminate the simulation
Simulation Mode -
#668 1 Simulation mode mode, switch device off and on
No Ventilation
again
- Possible impaired functionality
or restricted ventilator operation
Software Revision - Exchange control unit or dis-
#669 of Control Unit connect patient from device and
Control unit 1
and 5 1/2 Incompatible immediately continue ventilation
Control unit 2
#670 with Ventilator therapy with another ventilator
Unit - Immediately remove ventilator
from service

11.4 Alarm messages during power-on self-test

Code Error message Corrective measure

#201
Do not use ventilator, switch OFF,
to Sensor problem
contact authorised service agent
#269
#301
to Control unit error
#318
O2 supply Correct or acknowledge error,
#654
Low oxygen inlet pressure contact authorised service agent
O2 supply Do not use ventilator, switch OFF,
#655
High oxygen inlet pressure contact authorised service agent
Air supply Correct or acknowledge error,
#656
Low air inlet pressure contact authorised service agent
Air supply Do not use ventilator, switch OFF,
#657
High air inlet pressure contact authorised service agent
#801
Fault Alarm LEDs Ventilator Do not use ventilator, switch OFF,
to
Unit contact authorised service agent
#805
#811
and Fault Buzzer Ventilator Unit
#812
#813
Fault Power Supply Main Do not use ventilator, switch OFF,
and
Controller contact authorised service agent
#814
#815
Fault Power Supply Sensor Do not use ventilator, switch OFF,
and
Controller contact authorised service agent
#816


#817
Fault Power Supply Main Do not use ventilator, switch OFF,
to
Board contact authorised service agent
#826
Set date and time,
Buffer Battery
#827 ventilator may be used,
RTC Drained
#831
Measurement of ventilator
and Allow device to warm up
unit temperature < 5°C
#833
#832
Rule out presence of external heat sources
and Check ambient temperature
causing rise in temperature
#834
#835
Expiratory flow sensor heating Do not use ventilator, switch OFF,
to
defect contact authorised service agent
#837
Acknowledge error,
#841
Check all ventilator settings and alarm limits,
to Internal Memory Error
adapt if required
#847
Contact authorised service agent
#851
to Internal Safety Circuit Error
#855
#861
Defective battery in lower Replace battery or insert additional
to
compartment battery in upper compartment
#867
Remaining usage time on
#868 Connect Device to Mains
lower battery < 5 minutes
Capacity of battery in lower
#869 compartment is insufficient for Connect Device to Mains
number of accessory devices
#870
Defective battery in lower Replace battery or insert additional
to
compartment battery in upper compartment
#876
#877
Defective battery in upper Replace battery or insert additional
to
compartment battery in lower compartment
#883
Remaining usage time on
#884 Connect Device to Mains
upper battery < 5 minutes
Capacity of battery in upper
#885 compartment is insufficient for Connect Device to Mains
number of accessory devices


#886
Defective battery in Replace battery or insert additional battery in
to
upper compartment lower compartment
#892
#893 No Mains Voltage Connect Device to Mains
Mains connection cannot be Acknowledge error,
#894
established contact service agent
#895 Internal safety fault
#896 Fault Power Supply
Acknowledge error,
#897 Charging Circuit Defect
Acknowledge error,
#899 No battery ready for use
Insufficient battery charge Acknowledge error,
#900
level contact authorised service agent
AC Adapter in Ventilator Unit Acknowledge error,
#901
defect contact authorised service agent
Acknowledge error,
#902 Battery Charge Circuit Defect
#903 Fan Failure in Ventilator Unit
Acknowledge error,
#904 Battery Charge Circuit Defect
#906
to Power Manager Fault
#909
#911
to Internal Communication Error
#915
#921 O2 Sensor Defect
#922 Calibrate O2 sensor,
O2 Sensor Fault
and if problem persists, contact authorised service
Implausible values
#923 agent
#931
to Trend Memory Error Disable trending or overwrite trend memory
#939


Recommendation: do not use with patient,
#951 Restart after severe exception
#961 Maintenance Overdue Notify service
Firmware update of ventilator

#971 unit failed. Repeat firmware update
Please repeat firmware update
11.5 Alarm messages during system test


O2 supply System test continues when error has been
#654
Low oxygen inlet pressure acknowledged
O2 supply
#655 Repeat system test
High oxygen inlet pressure
Air supply System test continues when error has been
#656
Low air inlet pressure acknowledged
Air supply
High air inlet pressure
#1001
Fault Internal O2 Flow Meas-
to Repeat system test
urement Ventilator Unit
#1004
System test continues when error has been
#1005 Insufficient O2 Gas Supply
acknowledged, or repeat system test
Fault Internal O2 Flow Meas-
#1007
Fault Internal Air Flow Meas-
#1010
System test continues when error has been
#1011 Insufficient Air Gas Supply
acknowledged, or repeat system test


Fault Internal Air Flow Meas-
#1012 urement Repeat system test
Ventilator Unit
Repeat system test
- Check breathing circuit
#1013 Fault Internal Expiratory Flow
- Check correct assembly and order of inspira-
to Measurement
tory and expiratory valves
#1017 Ventilator Unit
- Check humidifier if applicable
Repeat system test
#1031
and Deviating Expiratory Pressure
- Check correct assembly of expiratory valve
#1036
#1041 Fault Internal Expiratory Pres-
and sure Measurement Repeat system test
Repeat system test
#1042
and Leak in Pneumatic System
#1046
Repeat system test
#1044
and Deviating Expiratory Pressure
- Check correct assembly of expiratory valve
#1048
#1045 Fault Internal Inspiratory
and Pressure Measurement Repeat system test
#1052
Internal Fault Process Gas
Valve
#1055
Repeat system test
#1051
and Leak in Pneumatic System
#1061
Repeat system test
- Check correct assembly inspiratory valve, or
#1056 Fault Safety Valve
replace valve
- If problem persists, contact service agent


Internal Fault Proportional
Valves
Repeat system test
Major Leakage in Breathing
#1063 - Check Y-connector, breathing circuit, expiratory
Circuit
valve, and expiratory flow sensor for leaks
#1071
to Pneumatic Nebulizer Fault Repeat system test
#1074
Repeat system test
#1075 - Check correct assembly and order of inspira-
Fault Internal Expiratory Flow
to tory and expiratory valves
Measurement Ventilator Unit
#1078 - Check expiratory flow sensor
- Calibrate oxygen sensor if applicable
#1079
O2 measurement outside Repeat system test
and
measuring range - Calibrate oxygen sensor
#1080
Repeat system test
- Check patient category
- Rule out use of coaxial breathing circuits
Measured Overall Resistance - Check breathing circuit for kinks
#1091
High - Check correct assembly and order of inspira-
Repeat system test
Oscillation Due to High - Check patient category
#1092
Resistance - Rule out use of coaxial breathing circuits
- Check breathing circuit for kinks
Repeat system test
Measured Inspiratory Resist- - Check patient category
#1093
ance High - Rule out use of coaxial breathing circuits
- Check breathing circuit for kinks
#1101
CO2 sensor reports error and
and Repeat system test
cannot be activated
#1102
CO2 Sensor Calibration Repeat system test
#1103
Required - Calibrate CO2 sensor
CO2 sensor reports error and
cannot be activated


Cleaning, disinfection, sterilisation | 12
12 Cleaning, disinfection and

sterilisation

12.1.1 Initial operation 140
12.2 Cleaning and disinfection 141
12.2.1 Ventilator unit and control unit 141
12.2.2 Machine cleaning with disinfection of the valve bar 141
12.3 Sterilisation 144
12.3.1 Valve bar 144
12.4 Visual inspection 145

12 | Cleaning, disinfection, sterilisation
12.1 General information

Important safety precautions:
• Observe the instructions for use and data sheets of the

cleaning agents and disinfectants.
Warning • Wear protective gloves and safety goggles.
• Do not inhale fumes.
Avoid damage:
• Do not use any organic, halogenated or mineral oil based

solvents, volatile anaesthetics, glass cleaners, acetone, sharp
or abrasive cleaning agents, e.g., steel wool, silver polish or
silver cleaners.
• Do not allow liquids to enter into the housing.
Caution • Keep liquids away from electronic components.
• Only autoclave parts that have been declared as detachable
and autoclavable in these instructions for use.
• Contact the manufacturer if you have questions concerning
cleaning agents or disinfectants.
Avoid patient contamination:
• Clean elisa 800 and sterilise the connected accessories after

each patient.
Warning • Comply with the general hygiene regulations of the hospital
or the national hygiene recommendations.
• Do not reuse components intended for single use.
12.1.1 Initial operation

At the time of delivery the ventilator is not sterilised or cleaned by the manufac-
turer in the clinical sense. Prior to initial operation on a patient, the device must
be prepared appropriately.

12.2 Cleaning and disinfection

12.2.1 Ventilator unit and control unit
Use a soft cloth and mild cleaning agent to clean the surface of the housing and
of the control unit.
'mikrozid® sensitive liquid' by 'Schülke & Mayr GmbH' (www.schuelke.com) is rec-

ommended for disinfection of the surface (use per manufacturer's instructions).
Do not allow liquid to enter the housing.
First lock the screen before disinfecting the surface of the control
unit during operation.
Remark
For further information, please refer to chapter 7.8.3 Lock and
unlock screen.
Before the equipment is put into service again, it must be ensured

that the ventilator unit and the control unit are completely dry.
Caution
12.2.2 Machine cleaning with disinfection of the valve bar

For machine cleaning and disinfection of the valve bar, an EN ISO 15883 compliant
washer disinfector can be used. It is suggested to use the cart for anaesthesia and
ventilation accessories for loading the item into the machine. Reliable flushing and
cleaning of the valve bar is facilitated by special adapters for the expiratory flow
sensor and the inspiratory and expiratory valves.
Please note that all valve bar parts may be contaminated by bodily
fluids or exhaled gases!
Warning
Observe the manufacturer's instructions for use of the cleaning

Remark
agents and disinfectants.

Remove the individual elements from the valve bar and separate all silicone parts.
In the case of normal contamination, the PEEP membrane (expiratory valve) can
remain assembled for cleaning and sterilisation. In the case of heavy contamina-
tion, it is also possible to completely disassemble the PEEP membrane. Place the
individual silicone parts in a separate preparation container for small parts.
Position all elements on the cart for anaesthesia and ventilation accessories so
that all interior spaces and surfaces are completely rinsed. Cleaning adapters are
used for this purpose.These will ensure that the gas-conveying interior spaces are
completely flushed and the water can run off freely.
The cleaning adapters are connected to the washer disinfector via four rinsing
nozzles and connected to the valve bar elements according to the following im-
ages:
A Expiratory flow sensor adapter

B Expiratory valve adapter
C Inspiratory valve adapter
S
S Flushing nozzle connections

S

Remark Observe the instructions for use of the washer disinfector.
Remark Use a cleaning agent suitable for anaesthesia accessories:
For machine cleaning with disinfection, "neodisher® MediClean forte" by "Chemis-

che Fabrik Dr. Weigert GmbH & Co. KG" (www.drweigert.de), applied according
to the manufacturer's instructions, is recommended.
Select a programme for anaesthesia accessories (e.g. Vario TD). Cleaning is per-
formed at 55°C (131°F) for a minimum of 10 minutes and thermal disinfection at
93°C (199.4°F) for a minimum of 5 minutes.
The final rinse must be carried out with demineralised water.
Pay attention to the correct order of the individual parts during the assembly of
the expiratory valve:
D
D Expiratory valve membrane
E Disc
F Silicone disc
E
Check that the free breathing membrane is placed correctly in the valve basket.
G Free breathing membrane

H Valve basket with mushroom valve G

After cleaning and disinfection take the valve bar from the washer disinfector and
carry out a visual inspection.
Subsequently, allow the parts to dry for at least 40 minutes.
12.3 Sterilisation
12.3.1 Valve bar
All valve bar components can be steam sterilised at 134°C (273.2°F). Minimum
sterilisation period is 3 minutes.
Use DIN EN 285 compliant vacuum steam sterilisers for sterilisation, preferably
with fractional vacuum.
Remark Observe the instructions for use of the autoclave.
Autoclave the expiratory flow sensor, expiratory and inspiratory

Remark
valves assembled.
Ethylene oxide diffusing into the components of the valve bar

pose a health hazard to the patient.Therefore, do not sterilise the
Warning valve bar with ethylene oxide.
All silicone parts of the valve bar must be replaced after 500 ster-
ilisation cycles or during annual maintenance, whichever occurs
Warning first.

12.4 Visual inspection

The faultless condition of all valve bar elements must be examined after prepa-
ration. Check that the following components are available and intact after prepa-
ration:
A Expiratory flow sensor

B Sealing plate B
C Sealing ring expiratory flow sensor
D Expiratory valve
E Expiratory valve membrane
F Disc
G Silicone disc
H Sealing ring expiratory valve
I Inspiratory valve A
C
J Metal disc
K Inspiratory valve membrane
L Free breathing membrane
M Valve basket
J
K
E
F
G
I
H L
D
M
Damaged or deformed parts must be replaced!

Warning
Please ensure that all individual parts are completely dry.

Caution


Maintenance | 13
13 Maintenance

13.2 Maintenance intervals 148
13.2.1 Annual maintenance 148

13 | Maintenance

elisa 800 has been designed as an intensive care ventilator that requires little
maintenance. The user does not have to perform any calibration. Maintenance
must be performed annually by an authorised service technician according to the
service interval indication. Detailed information can be found in the current elisa
800 Technical Manual.
Before and during maintenance or repair, it must be ensured that:

• elisa 800 is switched off and the power plug has been removed
• the batteries have been removed
• all tube components have been removed
These conditions do not apply for the technical safety inspections.
Preparation of the valve bar is mandatory after any service inter-

vention involving the valve bar.
Warning
13.2 Maintenance intervals

13.2.1 Annual maintenance
Annual maintenance includes:
• a technical safety inspection

• the replacement of filters and seals/gaskets
• the replacement of membranes and valve bar seals
• the calibration of the O2 sensor
13.2.2 Maintenance every 6 years

In addition to the annual maintenance measures, maintenance every six years
includes:
• the replacement of the O2 pressure regulator
13.2.3 Maintenance every 12 years

It is necessary to replace all active components of elisa 800 for safety reasons
during maintenance after 12 years.

Technical specifications | 14
14 Technical specifications

14.2 Supply 151
14.3 Technical data 152
14.4 Control unit 153
14.5 Default parameters 153
14.6 Increments and maximum performance range 154
14.7 Measuring functions 157
14.8 Guidance and manufacturer's declaration 158

14 | Technical specifications

Application
Intended use: Ventilation of humans
Area: Intensive care, recovery room, general ventilation,
intra-hospital patient transport
Use: stationary, mobile
Patient category: adults and children greater than 3.0 kg in weight
Neonates with a minimum body weight of 0.5 kg
(optional)
Dimensions and weight

Ventilator unit
width x depth x height: 400 x 350 x 220 mm
weight, net: 23 kg (incl. control unit)
Control unit
Cart
weight, net: 23 kg
Total
weight, net: 46 kg
Max. load: 10 kg
Operation
Menu control Touchscreen
Menu language: German, English, French, Italian, Dutch, Norwegian,
Swedish, Polish, Slovenian, Turkish, Spanish
Classification
Device class: II b (according to Directive 93/42/EEC, Annex IX)
Protection class: I (Protection against electric shock hazards by
protective earth terminal)
Applied part: Type BF (in accordance with EN 60601-1)
Duration of use: Continuous operation
Protection class: IP22
IP22:
Protected against solid objects with a diameter over 12 mm and
Remark
against falling drops of water when the housing is tilted at an
angle up to 15°.

Interfaces
Serial interface for connection of the CO2 sensor
Serial PDMS interface for transfer of patient data
Mesh nebulizer interface for connection of the mesh nebulizer
VIT interface interface for connection of VIT (option)
USB (rear of control unit) for saving screenshots and short-term trends
Electromagnetic compatibility
Tested according to: IEC/EN 60601-1-2
Noise emission
Sound pressure level: ≤ 50 dbA
Sound power level: ≤ 10-6 W
Environmental conditions
During operation
Temperature: 10 to 40°C
Atmospheric pressure: 60 to 106 kPa
Relative humidity: 0 to 95% (without condensation)
During storage and transport

Temperature: -20 to 60°C
Atmospheric pressure: 50 to 110 kPa
Relative humidity: 0 to 99% (without condensation)
At high humidity levels, it is not possible to completely rule out

condensation. If the device is constantly operated at high humidi-
Caution ty levels, corrosion can be expected.
14.2 Supply
Electrical supply
Main supply
Supply voltage 230 VAC (± 10%), 50 Hz
Power consumption: < 170 VA
Emergency supply
Battery type: Lithium ion
Quantity: 1 (+1 optional battery)
Activation: automatic if main supply fails
(can be replaced during operation)
Operating time: 120 minutes (depending on device configuration, the
operating time can be extended by reducing the screen
brightness)
Duration of charge: < 4h for one battery

The charge cycle may take significantly longer at temperatures

Remark
> 35°C.
Gas supply
Oxygen supply (O2) / Compressed air supply (AIR)
Pressure range: 200 to 600 kPa (29 to 87 PSI)
> 270 kPa (for flows greater than 100 l/min)
Max. overpressure: 1000 kPa (145 PSI)
Quality: medical gas, dry, oil and particle free
Connection: NIST
The operating pressure is set via the electromechanical expira-

Remark
tory valve.
All volume, flow and leakage data on the patient side refer to
Remark
BTPS, all others refer to STPD.
14.3 Technical data

Ventilation
depending on software revision
Ventilation modes:
and device configuration
Safety functions
Free breathing valve: mechanical
Safety valve: electric, pneumatic
Patient category: Adult, Paediatric
Max. inspiratory pressure: 100 mbar

Max. inspiratory flow: 180 l/min for each gas
Device compliance: < 2.0 ml/mbar*
Insp. resistance: < 1.5 mbar/l/s*
Exp. resistance: < 4.5 mbar/l/s*
* with breathing circuit, adults, 2 x 22 mm, length 1.8 m

14.4 Control unit

General
Screen type: 16:9 LCD display
Screen diagonal: 18.5"
Input system: Touchscreen (capacitive multi-touch)
Support: detachable
Display:
Curve presentation: three curves simultaneously, measurement
value table
Curve parameters: flow, airway pressure and volume over time
Curves: synchronised
Curve scale: automatic
Measurement value table: can be hidden
Display brightness
Brightness: adjustable
Adjustment range: 5 to 100%
In alarm condition: 100%, independent of the setting
Acoustic alarm
Alarm volume: adjustable
Adjustment range: 20 to 100% (55 to 95 dbA)
40 to 60% (72 to 82 dbA) in SW 1.00.0
Visual alarm
Display: Alarm messages on screen
red alarm light, yellow alarm light
Power indicator
Mains supply green LED on ON switch
14.5 Default parameters

The default parameters depend on the software version and the configuration of
your device. An authorised service technician can switch to another configuration
(password-protected).
A detailed overview of the default parameters can be found in

Remark
Appendix A "Default parameters".

14.6 Increments and maximum performance range

Parameter
Patient Min. value Max. value
Increment
category "configured" "configured"
O2 all 1% 21 % 100 %
Adult, Paedi- 100 /min
Rate 1 /min 0 /min
atric () (120 /min)
0.01 @ 0.0 - 1.0 s
Tinsp all 0.05 @ 1.0 - 1.5 s 0.2 s 15 s
0.10 @ 1.5 - 15 s
3.00 s or
Ramp all 0.05 s 0.05 s
0.8 * Tinsp
Pmax all 1 mbar 10 mbar 100 mbar
100 mbar
Pmin all 1 mbar 0 mbar
"60 mbar"
100 mbar -
Pinsp all 1 mbar 0 mbar
PEEP
0.5 @ 1 – 10 mbar
PEEP all OFF, 1 mbar 50 mbar
1.0 @ 10 – 50 mbar
100 mbar -
PS all 1 mbar 0 mbar
PEEP
PS Ramp all 0.05 s 0.05 s 2.00 s
0.1 @ 0.1 – 3.5 l/min
Flow trigger all OFF, 0.1 l/min 20.0 l/min
0.5 @ 3.5 – 20.0 l/min
Pressure 0.1 @ -0.1 – -3.5 l/min -20 mbar
all -0.1 mbar
trigger 0.5 @ -3.5 – -20.0 l/min "-10mbar"
Exp. trigger all 1% 0 25 %
1 @ 0 – 20 ml
2 @ 20 – 50 ml
5 @ 50 – 100 ml
Adult, Paedi- "50 ml" 4000 ml
Vt 10 @ 100 – 300 ml
atric () (10 ml) "2600 ml"
20 @ 300 – 1000 ml
50 @ 1000 – 1500 ml
100 @ 1500 – 4000 ml
0.1 @ 2.0 – 10.0 l/min
0.5 @ 10.0 – 30.0 l/
I-Flow all min 2.0 l/min 120.0 l/min
1.0 @ 30.0 – 120.0 l/
min
ByFlow all 0.5 l/min 3.0 l/min 30.0 l/min
PS Endflow all 5% 10 % 130 %
Adult, Paedi-
PS TI max 0.5 s 1.0 s 5.0 s
atric
Adult, Paedi-
Insp. Hold 1s 2s 30 s
atric
Adult, Paedi-
Exp. Hold 1s 2s 20 s
atric

Patient
Increment Min. value Max. value
category
Body weight Adult, Paediatric 1 kg 5 kg 500 kg
Acoustic alarm all 5% 20 % 100 %
Alarm
all 5% 20 % 100 %
brightness
Display
all 5% 5% 100 %
brightness
Alarm limits
Patient
category
0.1 @ 0.6 – 10.0
0.6 l, MV min
Adult 0.5 @ 10.0 – 20.0 60 l, OFF
+ 1 increment
MV max 1.0 @ 20.0 – 60.0
0.1 @ 0.6 – 10.0 0.6 l, MV min
Paediatric 20 l, OFF
0.5 @ 10.0 – 20.0 + 1 increment
0.1 @ 0.6 – 10.0
49.9 l, MV max –
Adult 0.5 @ 10.0 – 20.0 OFF or 0.5 l
1 increment
MV min 1.0 @ 20.0 – 50.0
0.1 @ 0.6 – 10.0 19.9 l, MV max
Paediatric OFF or 0.1 l
0.5 @ 10.0 – 20.0 – 1 increment
2 @ 10 – 50 50, TV min
Adult 5 @ 50 – 100 4000 ml, OFF
TV max + 1 increment
10 @ 100 – 300
Pressure
20 @ 300 – 1000
modes 10, TV min
Paediatric 50 @ 1000 – 1500 1000 ml, OFF
+ 1 increment
100 @ 1500 – 4000
2 @ 10 – 50 3900, TV max
Adult 5 @ 50 – 100 OFF 50
TV min - 1 increment
10 @ 100 – 300
Pressure
20 @ 300 – 1000
modes 980, TV max
Paediatric 50 @ 1000 – 1500 OFF 10
100 @ 1500 – 4000 - 1 increment
TV min Adult 5%
OFF, - 20% - 95%
Volume modes Paediatric 1%
Leakage all 5% 5% 95 %
60 s, ≤ apnoea
Apnoea Alarm all 5s 10 s
ventilation
Apnoea venti- 120 s, ≥ apnoea
all 5s 10 s
lation alarm
1 @ 3 – 100 /min 3 /min, Fmin
Fmax all 250 /min
5 @ 100 – 250 /min + 1 increment

Patient
category
1 @ 2 – 100 /min 245 /min, Fmax
Fmin all 2 /min
5 @ 100 – 245 /min - 1 increment
10 mbar , P
130, Pmax /
Plimit all 1 mbar min
Pinsp +10
+ 1 increment
50 mbar , Plimit -
Pmin all 1 mbar OFF, 0 mbar
1 increment
130, Pmax /
Pplateau max all 1 mbar OFF
Pinsp +10
Pmean min
Pmean max all 1 mbar 80 mbar, OFF
+ 1 mbar
80 mbar,
Pmean min all 1 mbar 1 mbar, OFF Pmean max
- 1 increment
PEEP max all 1 mbar 1 mbar + 20 mbar, OFF
OFF, - 20
PEEP min all 1 mbar - 1 mbar
mbar
O2 max
(relative to all 1% 1% 20 %, OFF
FiO2)
O2 min
(relative to all 1% - 20 %, OFF -1%
FiO2)
1 mmHg 115.0 mmHg,
etCO2 max all 1 mmHg
+ etCO2 min OFF
etCO2 max
etCO2 min all 1 mmHg OFF, 0 mmHg
– 1 mmHg
i CO2 max all 1 mmHg OFF, 0 mmHg 115 mmHg
Tube compensation
Patient
category
Diameter Adult, Paediatric 0.5 mm 4.0 mm 12.0 mm
Compensation all 5% 25 % 100 %
Nebulizer
Patient
category
60 min,
time all 5 min 5 min
continuous

14.7 Measuring functions

Instant View window
Range Resolution Accuracy
± 10 % or 100 ml
MV e 0.1 to 50 l 0.1 l
(greater value)
± 10 % or 10 ml
VT e 0 to 5000 ml 1 ml
(greater value)
PEAK -50 to 150 mbar 1 mbar ± (0.5 mbar + 2 %)
PEEP -50 to 150 mbar 1 mbar ± (0.5 mbar + 2 %)
F 0 to 200 /min 1 /min ± 1 /min
± 2.5 %
The O2 measurement accuracy is independent of
the respiratory rate, ambient pressure and I:E ratio.
The deviation from the calibrated value is:
<±0.4 % O2 in the first 24 hours
<±0.4 % O2 in the subsequent week (additional
deviation)
O2 15 to 110 % 1%
<±0.2 % O2 in each of the subsequent months (addi-
tional deviation)
Main stream CO2 sensor
Response time: < 4s, Rise time: < 0.4s
Side stream CO2 sensor: Response time: < 1s
O2 sensor inside device: Response time: < 11s
(according to EN ISO 80601-2-55:2012)
± (0.2 vol% + 2%
etCO2 0 to 15 vol% 0.1 vol% of the current
measured value)
Data Table window

Range Resolution Accuracy
Pmean -50 to 150 mbar 1 mbar ± (0.5 mbar + 2 %)
Pplateau -50 to 150 mbar 1 mbar ± (0.5 mbar + 2 %)
Leakage 0 to 99 % 1% ± 10 %
Vtrap 0 to 1000 ml 1 ml ± 20 %
0 to 99.9 mbar
PEEPi 0.1 mbar ± (0.5 mbar + PEEP + 2 %)
+ PEEP
P0.1 0 to -20 mbar 0.1 mbar ± 0.5 mbar
± 10% or 150 ml
MV spont. 0.1 to 50 l 0.1 l
(greater value)
MV spont. % 0 to 100 % 1% ± 10 %
RSBI 0 to 999 1 ± 10 %
MIP 0 to -50 mbar 0.1 mbar ± (0.5 mbar + 2 %)
RCexp 0.1 to 6 s 0.1 s ± 0.1 s

Compliance 0 to 250 ml/mbar 1 ml/mbar ± 20 %

Resistance 0 to 500 mbar/l/s 1 mbar/l/s ± 40 %
± 15 % or 10 ml
VTi 50 to 5000 ml 1 ml
(greater value)
14.8 Guidance and manufacturer's declaration

Electromagnetic emissions:
elisa 800 is intended for use in the electromagnetic environment specified below.
It is the responsibility of the customer or user to ensure that elisa 800 is operated
in such an environment.
Electromagnetic environ-
Emission tests Compliance
ment - guidance
RF emissions to CISPR 11 Class A

The system uses RF energy
only for its internal function.
Harmonic emissions to
Therefore, its RF emissions
IEC 61000-3-2 Class A
are very low and are not likely
to cause any interference in
Voltage fluctuations/flicker
nearby electronic equipment.
emissions to IEC 61000-3-3 Complies
Electromagnetic immunity:
elisa 800 is intended for use in the electromagnetic environment specified below.
It is the responsibility of the customer or user to ensure that elisa 800 is operated
in such an environment.
Electromagnetic
IEC 60601 test
Immunity test Compliance level environment -
level
guidance
Floors should be
± 6 kV ± 6 kV wood, concrete or ce-
Electrostatic discharge contact contact ramic tile. If floors are
(ESD) to IEC 61000- covered with synthet-
4-2 ± 8 kV ± 8 kV ic material, the relative
air air humidity should be at
least 30%.
Electromagnetic
IEC 60601 test
Immunity test Compliance level environment - guid-
level
ance

± 2 kV for power ± 2 kV for power

The mains power
Electrical fast supply lines supply lines
quality should be that of
transients/bursts to
a typical commercial or
IEC 61000-4-4 ± 1 kV for input/out- ± 1 kV for input/out-
hospital environment.
put lines put lines
±1 kV ±1 kV The mains power
Surges to differential mode differential mode quality should be that of
IEC 61000-4-5 a typical commercial or
± 2 kV common mode ± 2 kV common mode hospital environment.
< 5% UT < 5% UT
(> 95% dip in UT) for (> 95% dip in UT) for
The mains power
½ cycle ½ cycle
quality should be that of
40% UT 40% UT
(60% dip in UT) (60% dip in UT)
Voltage dips, short If the user of elisa 800
for 5 cycles for 5 cycles
interruptions and requires continued
voltage variations to operation during power
70% UT 70% UT
IEC 61000-4-11 mains interruptions, it
(30% dip in UT) (30% dip in UT)
is recommended that
for 25 cycles for 25 cycles
elisa 800 be powered
from an uninterruptible
< 5% UT < 5% UT
power supply (UPS).
(> 95% dip in UT) (> 95% dip in UT)
for 5 seconds for 5 seconds
Power frequency mag-
netic fields should be
Power frequency (50
at levels characteristic
Hz) magnetic field to 3 A/m 3 A/m
of a typical location in
IEC 61000-4-8
Remark: UT is the AC mains voltage prior to application of the test level.

Electromagnetic
IEC 60601 test
Immunity test Compliance level environment -
level
guidance
Portable and mobile RF communications equipment should be used no closer to elisa 800, includ-
ing cables, than the recommended separation distance calculated from the equation applicable to
the frequency of the transmitter.
3 V rms
150 kHz to 80 MHz 3V d = 1.2√P
Conducted RF to outside the ISM bands a
IEC 61000-4-6 10 V rms
150 kHz to 80 MHz 10 V d = 1.2√P
within the ISM bands a
d = 1.2√P
Radiated RF to 10 V/m for 80 MHz to 800 MHz
10 V/m
IEC 61000-4-3 80 MHz to 2.5 GHz d = 2.3√P
for 800 MHz to 2.5 GHz
Recommended separation distance: where P is
the output power rating of the transmitter in
watts (W) according to the transmitter manu-
facturer and d is the recommended separation
distance in metres (m). b Field strengths from
fixed RF transmitters, as determined by an elec-
tromagnetic site survey c, should be less than
the compliance level in each frequency range. d
Interference may occur in the vicinity of equip-
ment marked with the following symbol.
Note 1 At 80 MHz and 800 MHz, the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic

Note 2 propagation is affected by absorption and reflection from struc-
tures, objects, and people.

a
The ISM bands (for industrial, scientific and medical application) between 150 kHz
and 80 MHz are 6.765 MHz to 6.795 MHz, 13.553 MHz to 13.567 MHz, 26.957
MHz to 27.283 MHz and 40.66 MHz to 40.70 MHz.
b
The compliance level in the ISM frequency bands between 150 kHz and 80 MHz
and in the frequency range of 80 MHz to 2.5 GHz is intended to reduce the prob-
ability that portable communications equipment could cause interference if it is
inadvertently brought into patient areas.
This is why an additional factor of 10/3 is used in order to calculate the recom-
mended distance for transmitters in these frequency ranges.
c
Field strengths from fixed transmitters, such as base stations for radio (cellular/
cordless) telephones and land mobile radios, amateur radios, 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 electro-
magnetic site survey should be considered. If the measured field strength in the
location in which the equipment is used exceeds the applicable RF compliance
level above, the equipment should be observed to verify normal operation. If ab-
normal performance is observed, additional measures may be necessary, such as
re-orienting or relocating the system.
d
Over the frequency range of 150 kHz to 80 MHz, field strengths should be less
than 3 V/m.


Default parameters | A
A Default parameters
A.1 Default parameters 164

A.1.1 Default parameters 164
A.1.2 Adjustment ranges 165
A.1.3 Default alarm limits 165

A | Default parameters
A.1 Default parameters

A.1.1 Default parameters
Patient category Adult Paediatric
BiLevel BiLevel
Ventilation mode at
start-up
Body weight 75 kg 25 kg
compensation: 100 % compensation: 50 %
diameter: 7.5 mm diameter: 6.0 mm
Tube compensation
inspiratory: ON inspiratory: OFF
expiratory: OFF expiratory: OFF
O2 50 % 50 %
P insp 10 mbar + PEEP 7 mbar + PEEP
PEEP 5 mbar 5 mbar
Ramp 0.10 s 0.10 s
Rate 10 /min 20 /min
T insp 1.5 s 1.0 s
Vt 400 ml 150 ml
I-Flow 24 l/min 18 l/min
Trigger (Flow) 5.0 l/min 3.0 l/min
Exp. trigger OFF OFF
PS 10 mbar + PEEP 9 mbar + PEEP
PS Endflow 25 % 25 %
PS Ramp 0.10 s 0.10 s
PS TImax 4.0 s 3.0 s
T_exsp 4.0 s 2.0 s
P min 0 mbar 0 mbar
P max 35 mbar 20 mbar
Byflow 3.0 l/min 3.0 l/min

Default parameters | A
A.1.2 Adjustment ranges
O2 21 - 100 %
Flow trigger 0.1 - 20 l/min
Pressure trigger 0.1 - 10 mbar
PEEP 0 - 50 mbar
P insp 0 - 60 mbar
Vt 10 - 2600 ml
PS 0 - 100 mbar
Pmax 10 - 100 mbar
Ramp 0.05 - 3 s
PS Ramp 0.05 - 2 s
Exp. trigger 0 - 25 %
PS Endflow 5 - 70 %
Rate 0 - 100 /min (children: 0-120/min)
A.1.3 Default alarm limits

Patient category Adult Paediatric
MVmin 2.5 l 2.5 l
MVmax 12.0 l 5.0 l
Vtmin (pressure modes) 150 ml 50 ml
Vtmax OFF OFF

Fmin 6 /min 14 /min
Fmax 50 /min 60 /min
Apnoea alarm 20 s 20 s
Apnoea ventilation 30 s 30 s
Plimit
40 mbar 20 mbar
(a)VCV, SIMV, Dyn.
or Pmax + 10 mbar or Pmax + 10 mbar
BiLevel
Plimit 40 mbar or 20 mbar or
Bilevel, CPAP / PS Pinsp + PEEP + 10 mbar Pinsp + PEEP + 10 mbar
Pmin OFF OFF

A | Default parameters
Pmean max OFF OFF

Pmean min OFF OFF
Pplateau max OFF OFF
PEEPmax + 2 mbar + 2 mbar
PEEPmin - 2 mbar - 2 mbar
Leakage 50 % 50 %
O2 max set FiO2 + 5% set FiO2 + 5%
O2 min set FiO2 - 5% or 18% set FiO2 - 5% or 18%
etCO2 max 8.0 Vol% or 60 mbar 8.0 Vol% or 60 mbar
etCO2 min OFF OFF
inCO2 max OFF OFF
F spont. max OFF OFF
F spont. min OFF OFF

Ventilation modes and parameters | B
B Ventilation modes and

parameters
B.1 Default settings 168
B.2 Default ventilation 168
B.3 Ventilation modes 168
B.3.1 BiLevel ST 170
B.3.2 Dynamic BiLevel ST 171
B.3.3 Dual BiLevel ST 172
B.3.4 BiLevel 173
B.3.5 Mandatory BiLevel 174
B.3.6 Dynamic BiLevel 175
B.3.7 Dual BiLevel 176
B.3.8 Optional BiLevel 176
B.3.9 Flexible BiLevel 178
B.3.10 PC-SIMV 179
B.3.11 PSV 180
B.3.12 Dynamic PSV 181
B.3.13 Proportional PSV 182
B.3.14 CPAP 183
B.3.15 VCV 184
B.3.16 PLV 185
B.3.17 VC-SIMV 186
B.3.18 Optional VCV 187
B.3.19 Flexible VCV 188
B.3.20 Volume-adaptive BiLevel 189
B.3.21 PC APRV 190
B.3.22 PCV 191
B.3.23 CPR 192
B.3.24 HFOT 194
B.4 Ventilation parameters 195
B.4.1 Trigger 198
B.5 Apnoea ventilation 199
B.6 Setting alarm limits 200
B.7 Overview of alarm limits 201
B.7.1 Ventilation alarms 201
B.7.2 Sensor alarms 202

B | Ventilation modes and parameters
B.1 Default settings

Once a new patient has been selected in the standby mode, the default ventila-
tion mode including all default parameters is automatically activated. The default
settings can be configured as needed (see chapter "5.2 Configuration"). The au-
tomatically activated default ventilation mode is the first mode on the tab bar
(BiLevel in our example).
The tab with the name of the active ventilation mode is highlighted with a differ-
ent colour.
The following colour scheme helps to quickly identify the mode:
NIV (non-invasive) green

IV (invasive) grey
Apnoea ventilation yellow
Resuscitation (or CPR) mode red
B.2 Default ventilation

(see chapter "5.2 Configuration").
B.3 Ventilation modes

The ventilation modes available depend on the software revision, the device con-
figuration and the selected patient settings (e.g., mask, tube, HFOT, etc.).
Tube Mask Nasal cannula

BiLevel ST ---
Dynamic BiLevel ST ---
Dual BiLevel ST ---
BiLevel ---
Mandatory BiLevel ---

Dynamic Bi-Level ---

Dual BiLevel ---
Optional Bi-Level ---
Flexible Bi-Level --- ---
PC-SIMV --- ---
PSV ---
Dynamic PSV ---
Proportional PSV ---
CPAP ---
VCV --- ---
PLV --- ---
VC-SIMV --- ---
Optional VCV --- ---
Flexible VCV --- ---
VA BiLevel ---
PC APRV --- ---
PCV ---
CPR --- ---
HFOT --- ---

B.3.1 BiLevel ST
BiLevel Spontaneous Timed.
Synchronised, pressure-controlled ventilation which allows the patient to breathe
spontaneously during the entire respiratory cycle.
The patient has the option of unrestricted spontaneous breathing at both adjust-
able pressure levels. Switching between both pressure levels guarantees a man-
datory minute volume and facilitates spontaneous breathing at the PEEP level on
the lower pressure level or pressure support. In contrast to conventional BiLevel
ventilation, the ventilator calculates a cycle time on the basis of the set respirato-
ry rate. If spontaneous breathing activity does not occur within the cycle time, a
mandatory BiLevel stroke is triggered.

B.3.2 Dynamic BiLevel ST

Dynamic BiLevel Spontaneous Timed.
Combination of BiLevel ST mode and dynamic BiLevel with dynamic adjustment
of the mandatory ventilation pressure and the possibility of spontaneous breath-
ing during the entire ventilation cycle.
Breath cycles are defined by setting a fixed respiratory rate (60/f). If spontaneous
breathing results in the machine's trigger threshold being reached, the spontane-
ous breath will be supported with the set pressure. If the patient fails to breathe
spontaneously during the cycle, the machine will initiate a conventional BiLevel
breath with volume guarantee (= dynamic BiLevel) at the end of the calculated
cycle time. In patients with no spontaneous breathing activity, ventilatory support
is delivered in the form of the set mandatory minute volume (f x Vt). In patients
who stop breathing for short periods of time, the mandatory ventilation compo-
nents provide an intelligent back-up system for apnoea ventilation.

B.3.3 Dual BiLevel ST

Dual BiLevel Spontaneous Timed.
Combination of BiLevel ST mode and dual BiLevel, allowing spontaneous breaths
during the entire respiratory cycle. The dynamic adaption of the ventilation pres-
sure refers to the mandatory and spontaneous portions of the respiratory cycle.
Breath cycles are defined by setting a fixed respiratory rate (60/f). If spontane-
ous breathing results in the machine's trigger threshold being reached, pressure
support with volume guarantee (= dynamic PSV) will be provided for the spon-
taneous breath. If the patient fails to breathe spontaneously during the cycle,
the machine will initiate a conventional BiLevel breath with volume guarantee
(= dynamic BiLevel) at the end of the calculated cycle time. In patients with no
spontaneous breathing activity, ventilatory support is delivered in the form of the
set mandatory minute volume (f x Vt). In patients who stop breathing for short
periods of time, the mandatory ventilation components provide an intelligent
back-up system for apnoea ventilation.

B.3.4 BiLevel
spontaneously during the entire respiratory cycle.
The patient has the option of unrestricted spontaneous breathing at both adjust-
able pressure levels. Switching between both pressure levels guarantees a man-
datory minute volume and facilitates spontaneous breathing at PEEP level at the
lower pressure level or pressure support.
The desired minute volume is determined by the set pressure difference be-
tween the upper (Pinsp) and lower CPAP level (PEEP) and the set respiratory
rate (Rate). The tidal volume achieved depends mainly on the compliance and re-
sistance of the patient's lungs. Inspiration and expiration times (I:E) and the ramp
time between the lower and upper pressure level have an impact on the pressure
and flow curves.
The base pressure level is set with the positive end-expiratory pressure (PEEP).
Although this is a mandatory mode, the patient is allowed to breathe sponta-
neously during the inspiration and expiration phase. This enables the patient to
increase the minute volume beyond the mandatory values set.

B.3.5 Mandatory BiLevel

Synchronised, pressure-controlled ventilation mode, allowing the patient to
breathe spontaneously at the upper level and initiating a mandatory breath for
each trigger variable.
In contrast to the conventional BiLevel mode, the ventilator performs the entire
work of breathing. Consequently, BiLevel breaths are time-cycled via the set res-
piratory rate and also initiated via the trigger function.
This mode does not allow additional pressure-support, nor does it allow man-
datory inspiration time to be shortened in response to an expiratory trigger
variable, which would relieve the patient significantly. The tidal volume delivered
is determined by the difference between the lower pressure level (PEEP) and the
upper pressure level (Pinsp), and is dependent upon lung elasticity (compliance).

B.3.6 Dynamic BiLevel

Synchronised, volume-targeted, pressure-controlled ventilation with dynamic ad-
justment of the mandatory ventilation pressure and spontaneous breaths during
the entire ventilation cycle.
This enhancement of the conventional BiLevel mode reduces the need for ad-
justments and prevents overdistension of the lungs with improving mechanics of
breathing.With dynamic BiLevel the advantages of pressure-controlled ventilation
are combined with the possibility of unrestricted spontaneous breathing at both
pressure levels with a constant volume.
Depending on the current lung situation, the ventilator adapts the upper pressure
level so that the set tidal volume is applied with the lowest possible inspiratory
pressure.
The Pmax. and Pmin. parameters determine a range in which the ventilator is
allowed to automatically readjust the necessary pressure to achieve the desired
tidal volume.

B.3.7 Dual BiLevel

Synchronised, volume-targeted, pressure-controlled ventilation with the pos-
sibility of spontaneous breaths during the entire ventilation cycle. The dynamic
adaption of the ventilation pressure refers to the mandatory and spontaneous
portions of the respiratory cycle.
With Dual BiLevel the advantages of pressure-controlled ventilation are com-

bined with the possibility of unrestricted spontaneous breathing at both pressure
levels with a constant volume.
level or the necessary pressure support for spontaneous breathing so that the set
tidal volume is applied with the lowest possible inspiratory pressure.
tidal volume.
B.3.8 Optional BiLevel

spontaneously during the entire respiratory cycle. If the measured minute volume
is above the setting (Rate x Vt), the patient is able to breathe spontaneously. If the
minute volume drops below the setting, BiLevel strokes are triggered.

This mixed form of ventilation combines a synchronised, pressure-controlled, vol-

ume-targeted ventilation mode to ensure a specified minute volume with the
possibility of achieving deeper breaths using pressure support.
Depending on the current lung situation, the ventilator adapts the mandatory
pressure level so that the set tidal volume is applied with the lowest possible
inspiratory pressure.
tidal volume.
In contrast to conventional SIMV ventilation, the user defines a minimum minute

volume by setting the respiratory rate and tidal volume. No mandatory breaths
are initiated if the minute volume can be achieved by the patient's spontaneous
breathing.
The ventilator continuously monitors the patient's respiratory activity. If the min-
ute volume drops below the preselected value, a mandatory breath is initiated. If
spontaneous breathing fails completely, the patient is ventilated with the selected
mandatory respiratory rate.

B.3.9 Flexible BiLevel

spontaneously during the entire respiratory cycle. If the measured minute volume
is above the setting (Rate x Vt), the patient is able to breathe spontaneously. BiLev-
el strokes are triggered with a dynamic adjustment of the mandatory ventilation
pressure if the minute volume drops below the setting.
With flexible BiLevel the advantages of pressure-controlled ventilation are com-

bined with the possibility of unrestricted spontaneous breathing at both pressure
levels with a constant volume.
level or the necessary pressure support of spontaneous breathing so that the set
tidal volume is applied with the lowest possible inspiratory pressure.
tidal volume.
In contrast to conventional SIMV ventilation, the user defines a minimum minute

breathing.

The ventilator continuously monitors the patient's respiratory activity. If the min-
ute volume drops below the preselected value, a mandatory breath is initiated. If
spontaneous breathing fails completely, the patient is ventilated with the selected
mandatory respiratory rate.
B.3.10 PC-SIMV
Pressure Controlled - Synchronised Intermittent Mandatory Ventilation. Synchro-
nised, pressure-controlled ventilation with the possibility of spontaneous breath-
ing between the controlled breaths.
This mixed form of ventilation combines a synchronised, pressure-controlled ven-

tilation mode to ensure a specified minute volume with the possibility of achieving
deeper spontaneous breaths using pressure support.
rate (Rate). The tidal volume achieved depends mainly on the compliance and
resistance of the patient's lungs. Inspiration and expiration time (I:E) and the ramp
time between the lower and upper pressure level have an impact on the pressure
and flow curves.
In this mixed form of ventilation the system permits spontaneous breathing at the
lower pressure level. As a result, the minute volume may exceed the set mandato-
ry value. By setting the PS pressure support, the patient's work of breathing at the
lower pressure level can be reduced. Initiated by reaching the set trigger thresh-

old, the ventilator delivers the required flow in order to increase the pressure to
the specified PS pressure beyond the PEEP value.
The pressure-supported mandatory breath is terminated when the flow to the

patient (measured in percent of the highest PS flow) drops to the specified PS
end flow.
The pressure rise time from the PEEP value to the PS pressure (PS) can be set via
the PS ramp time. The shorter the ramp time, the higher the initial PS flow.
B.3.11 PSV
Pressure Support Ventilation. Pressure-supported spontaneous breathing at the
CPAP pressure level.
Pressure support reduces the patient's work of breathing by increasing the tidal
volume. Initiated by reaching the set trigger threshold, the ventilator delivers the
required flow in order to increase the pressure to the specified PS pressure be-
yond the PEEP value.

patient (measured in percent of the highest PS flow) drops to the specified PS end
flow. The pressure rise time from the PEEP value to the PS pressure (PS) can be
set via the PS ramp time.The shorter the ramp time, the higher the initial PS flow.

B.3.12 Dynamic PSV

Pressure Support Ventilation. Pressure-supported spontaneous breathing at the
CPAP pressure level with dynamic adjustment of the pressure support.
Pressure support reduces the patient's work of breathing by increasing the tidal
volume. Initiated by reaching the set trigger threshold, the ventilator delivers the
required flow increase the pressure to the PS pressure beyond the PEEP value,
which is required to achieve the specified tidal volume.
The PLimit alarm limit determines a range in which the ventilator is allowed to
automatically readjust the necessary pressure to achieve the desired tidal volume.

patient (measured in percent of the highest PS flow) drops to the specified PS
end flow.
The pressure rise time from the PEEP value to the PS pressure (PS) can be set via
the PS ramp time. The shorter the ramp time, the higher the initial PS flow.

B.3.13 Proportional PSV

Proportional Pressure Support Ventilation
A technological advancement over conventional PSV. In spontaneously breath-

ing patients, pressure support is delivered at a level that is proportional to the
degree of compensation required in relation to flow resistance (Flow Support)
and airway resistance (Volume Support). This partially replaces the patient's work
of breathing and allows deeper breaths. The level of pressure support delivered
varies from breath to breath and is dependent upon air flow and inspired volume.
As a measure to prevent pressure peaks resulting from potential

overcompensation, both the upper pressure limit (Pmax) and the
Warning alarm limits need to be adapted to the patient condition.
This ventilation mode relies on a stable respiratory drive.

Warning
Before activating proportional pressure support, bronchopleural

fistulas and uncuffed endotracheal tubes must be ruled out.
Warning
Remark This mode is not available for non-invasive ventilation.

B.3.14 CPAP
Continuous Positive Airway Pressure Spontaneous breathing at ambient pressure
level or with continuous positive airway pressure (CPAP).
CPAP ventilation is a form of ventilation that combines that patient's spontane-

ous breathing with a constant overpressure (PEEP). The patients themselves can
determine the depth of their respirations, the rate and the flow.

B.3.15 VCV
Volume controlled ventilation with constant mandatory minute volume (Volume
Constant, Controlled Ventilation).
The desired mandatory minute volume is determined by the set tidal volume (Vt)
and the set rate (Rate). Inspiration and expiration times (I:E) and the inspiratory
flow (I-flow) determine the pressure and flow curves. The system automatically
generates an inspiratory pause (plateau) and its duration depends on the flow
and times. The higher the I-flow the longer the pause (plateau)-time. Spontane-
ous breathing at PEEP level which can increase the respiratory minute volume
is possible. The patient can trigger additional mandatory breaths once the set
trigger variable has been reached.This changes the actual respiratory rate and the
respiratory minute volume.

B.3.16 PLV
Conventional volume-controlled ventilation (pressure limited ventilation) with
optional pressure control.
By setting a pressure limit (Pmax), undesired pressure peaks can be prevented.

When reaching the pressure limit, the flow velocity will drop and a decelerating
flow pattern emerges. The resulting slower flow reduces the duration of the pla-
teau pressure interval within the set inspiratory time. The set tidal volume can
be applied at a constant level as long as an arithmetical minimum plateau time is
available.
When the pressure limit is reached, a message rather than a me-

Remark
dium priority alarm is output.

B.3.17 VC-SIMV
Volume Controlled - Synchronised Intermittent Mandatory Ventilation. Synchro-
nised, volume-controlled ventilation with the possibility of breathing spontane-
ously between the controlled breaths.
This mixed form of ventilation combines a synchronised, volume-controlled venti-

lation mode to ensure a defined minute volume with the possibility of deepening
the patient's spontaneous breaths by pressure support. The desired mandatory
minute volume is determined by the set tidal volume (Vt) and the set rate (Rate).
Inspiration and expiration times (I:E) and the inspiratory flow (I-flow) determine
the pressure and flow curves. The system automatically generates an inspiratory
pause (plateau) and its duration depends on the flow and times. The higher the
I-flow the longer the pause (plateau)-time.

B.3.18 Optional VCV

Synchronised, volume-controlled ventilation, allowing the patient to breathe
spontaneously at PEEP level or with the set pressure support. If the measured
minute volume is above the setting (Rate x Vt), the patient is able to breathe
spontaneously. If the minute volume drops below the setting, volume-controlled
respirations are triggered.
Optional VCV combines the advantages of volume-controlled ventilation with the

possibility of spontaneous breathing at PEEP level with a set pressure support. In
contrast to conventional SIMV ventilation, the user defines a minimum minute
breathing.

B.3.19 Flexible VCV

Synchronised, volume-controlled ventilation, allowing the patient to breathe
spontaneously at PEEP level or with dynamic pressure support. If the measured
minute volume is above the setting (Rate x Vt), the patient is able to breathe
spontaneously. The dynamic adjustment of the pressure support adjustment cor-
responds with the set tidal volume. If the minute volume drops below the setting,
volume-controlled respirations are triggered.
Flexible VCV combines the advantages of volume-controlled ventilation with the

possibility of spontaneous breathing at PEEP level with a dynamic adjustment of
the pressure support. In contrast to conventional SIMV ventilation, the user de-
fines a minimum minute volume by setting the respiratory rate and tidal volume.
No mandatory breaths are initiated if the minute volume can be achieved by the
patient's spontaneous breathing.

B.3.20 Volume-adaptive BiLevel

Synchronised, volume-targeted, pressure-controlled ventilation with dynamic ad-
justment of the mandatory ventilation pressure and spontaneous breaths during
the entire ventilation cycle.
This enhancement of the conventional BiLevel mode reduces the need for ad-
justments and prevents overdistension of the lungs with improving mechanics of
breathing.
With VA BiLevel the advantages of pressure-controlled ventilation are combined

with the possibility of unrestricted spontaneous breathing at both pressure levels
with a constant volume.
Each of the patient's inspiratory efforts (attaining the set trigger threshold) on the
PEEP level will trigger a synchronised mandatory ventilation stroke. This allows
the patient to determine the timing and number of mandatory breaths.
level so that the set tidal volume is applied with the lowest possible inspiratory
pressure.
tidal volume.

B.3.21 PC APRV
Airway Pressure Release Ventilation is a modified BiLevel mode with inverse in-
spiratory to expiratory time ratio. Patients normally breathe spontaneously on
the upper pressure level. CO2 elimination is achieved by briefly lowering airway
pressure to the lower pressure level (PEEP). At the same time, these short pres-
sure release phases are intended to prevent the collapse of lung areas that are
ventilated more slowly.

B.3.22 PCV
Synchronised, time- and pressure-controlled ventilation mode with two adjust-
able pressure levels, allowing unimpeded spontaneous breathing on the lower
pressure level. Switching between both pressure levels guarantees a mandatory
minute volume and facilitates spontaneous breathing at PEEP level on the lower
pressure level, which increases the respiratory volume. Additional triggers start
additional mandatory breaths.
rate (Rate). The tidal volume achieved depends mainly on the compliance and
resistance of the patient's lungs.

B.3.23 CPR
In the CPR mode, the ventilation settings automatically adapt to the individual
conditions of ventilated patients in need of resuscitation. Additionally, some of the
audible alarms are deactivated, while measurement of the end-tidal CO2 concen-
tration is activated.
The CPR mode is only available in the Adult patient category and can be enabled
at the configuration level.
When you select and confirm the CPR mode, the patient will receive modified
BiLevel ventilation with the following parameter settings:
O2: 100%
PEEP: unchanged
Pinsp: 20 (+PEEP) mbar
Tinsp: 1.0 s
Trigger: inactive
The window of the active ventilation mode is highlighted red.
The end-tidal CO2 measurement is activated automatically. The displayed meas-

ured values are based on the last calibration values. Audible alarms are deactivat-
ed to reduce the stress level; hence, the alarm limits in the Instant View window
are highlighted red. At the same time, the info bar continuously indicates the
duration of the CPR mode.

Some of the audible alarms are inactive.The CPR mode shall only
be applied in the presence and under direct supervision of quali-
Warning fied healthcare professionals.
The compliance of the thorax changes during resuscitation meas-

ures, which is reflected by appropriate parameter settings in the
CPR mode. The user is required to adapt these settings to the
Warning clinical situation when needed.
To continue ventilating the patient after the resuscitation inter-

vention
• select another mode
Warning • check the parameter settings and alarm limits and adapt them
to the clinical situation.

B.3.24 HFOT
In the High Flow Oxygen Therapy mode, elisa 800 can also be used as flow gener-
ator for nasal CPAP therapy. For this application, the flow setting determines the
therapeutic CPAP level.
Select this mode with the "nasal cannula" button in the patient interface area.
On the selector, flow rates greater than 60 litres per minute

are coloured yellow. When operating in this range, the clinical
Warning risk-benefit ratio must be critically assessed.
Using a respiratory gas humidifier which humidifies and heats the

respiratory gas is the prerequisite for higher flow rates and ulti-
Warning mately for generating PEEP.

B.4 Ventilation parameters

Different parameters are available to set the ventilation modes:
O2 Inspiratory O2 concentration
PEEP Positive end-expiratory pressure
Ramp Time ramp between PEEP and Pinsp
PS Ramp Time ramp between PEEP and PS
Pinsp Inspiratory pressure
PS Pressure support
Inspiratory time,
Tinsp
inspiratory/expiratory ratio I:E is also shown
PS TImax Maximum duration of inspiratory phase with pressure support
Expiratory trigger with pressure-controlled ventilation
Exp. trigger Percentage of the trigger expectation window
for the synchronised switch to expiration
PS Endflow Stop criterion of inspiratory phase with pressure support
Rate Respiratory rate
The ventilator detects the patient's attempts to breathe in via the trigger.
Trigger sensitivity can be individually adapted to the patient. The lower the
Trigger set value the more sensitive the ventilator is to patient's attempts at inhaling.
At very low sensitivities, the elasticity of the ventilation tubes could cause a
trigger signal (auto-triggering).
Vt Tidal volume
As bias flow, the Byflow provides the set trigger flow and simultaneously pre-
sents a kind of "flow reservoir" for the spontaneously breathing patient. The
Byflow function is available in all ventilation modes. The setting can be in-
Byflow
creased if the dynamic behaviour of the device is unsatisfactory during or after
a triggering with uncuffed tubes or if rebreathing of CO2 is to be prevented
when a ventilation helmet is used.
A pressure limitation can be set in order to rule out excessively high pressure
values in case of an acute worsening of the mechanics of breathing. No further
pressure adjustments are carried out if the pressure limit has been reached.
Pmax
The "Pressure Limitation" alarm is triggered. The VTmin alarm limit must be
set in order to be able to recognise that the set tidal volume has not been
reached.
In pressure-controlled or pressure-supported ventilation modes with speci-
fied volumes, Pmin represents the lower pressure adaptation window. If the
Pmin required pressure drops below this setting, the automatic pressure adaptation
is suspended. To prevent unintended high tidal volumes, it is necessary to set
the Vtmax alarm limit.
I-Flow inspiratory gas flow rate
Flow support Extent of the resistance compensation
Volume sup-
Extent of the compliance compensation
port

The tables below provide an overview of the adjustable ventilation parameters:
Dual BiLevel ST
Dyn. BiLevel ST
Mand. BiLevel
Opt. Bi-Level
Dual BiLevel
Dyn. BiLevel
VA BiLevel
BiLevel ST
PC-APRV
BiLevel
PCV
O2 x x x x x x x x x x x
PEEP x x x x x x x x x x x
Ramp x x x x x x x x x x x
PS Ramp x x x x x x x x x
Pinsp x x x x x
PS x x x x x
Tinsp x x x x x x x x x x x
Texp x
PS TImax x x x x x x x
Exp. trigger x x x x x x x x x
PS Endflow x x x x x x x
Rate x x x x x x x x x x
Trigger x x x x x x x x x x x
Vt x x x x x x
Byflow x x x x x x x x x x x
Pmax x x x x x x
Pmin x x x x x x
Flex. PC-SIMV PSV Dyn. PSV Prop. PSV CPAP

BiLevel
O2 x x x x x x
PEEP x x x x x x
Ramp x x
PS Ramp x x x x
Pinsp x
PS x x
Tinsp x x x x
Texp

PS TImax x x x x x
Exp. trigger x x
PS Endflow x x x x x
Rate x x
Trigger x x x x
Vt x x
Byflow x x x x x
Pmax x x x
Pmin x x
Flow support x
Vol. support x
VCV VC-SIMV Opt.VCV Flex.VCV PLV HFOT

O2 x x x x x x
PEEP x x x x x
Ramp
PS Ramp x x x
P insp
PS x x
Tinsp x x x x x
Texp
PS TImax x x x
Exp Trigger
PS Endflow x x x
Rate x x x x x
Trigger x x x x x
Vt x x x x x
I-Flow x x x x x x
Byflow x x x x x
Pmax x x x x x x
Pmin x

B.4.1 Trigger
The trigger function synchronises the ventilator and the patient. Depending on
the selected ventilation mode and patient activities, mandatory ventilation strokes
can be initiated via a flow or pressure trigger or the pressure support can be acti-
vated to enable deeper spontaneous breaths. The ventilator detects the patient's
attempts to breathe in via the trigger, and the trigger sensitivity can be individually
adapted to the patient. The lower the set value the more sensitive the ventilator
is to patient's attempts at inhaling. At very low sensitivities, the elasticity of the
ventilation tubes could cause a trigger signal (auto-triggering).
On the pressure curve, inspirations initiated by the trigger variable are marked
by a different colour.
Switching between flow and pressure trigger is done with the selector at the
minimum trigger value or at OFF. The indication "Flow trig." and "Press. trig." is
displayed as appropriate. The desired trigger function is available after selection
and confirmation.
When the trigger function is switched off, no pressure support

Remark
is available in any of the modes to assist spontaneous breathing.

B.5 Apnoea ventilation

An apnoea ventilation mode, which completely takes over the patient's ventilation
in case of apnoea, is available in each ventilation mode.
To change the settings of the apnoea ventilation parameters, open the menu with
the (A) button in the ventilation and apnoea mode window.
The button shows the selected apnoea mode, the set rate and tidal volume or
inspiratory pressure.
By pressing the "No Apnoea Ventilation" button (B), you can deactivate the ap-
noea ventilation function. If the apnoea mode is deactivated, the button is yellow
and displays the message "Apnoea Ventilation not activated".

Only some specific parameters can be set in the apnoea ventila-

Remark tion mode. The other parameters depend on the settings for the
normal ventilation mode.
The apnoea interval, i.e., the time after which apnoea ventilation
Remark is activated, can be set in the ventilation alarms under "Apnoea
ventilation".
The apnoea ventilation function can be terminated as follows:

(C) manually: with the "Terminate Apnoea Mode" button
(D) automatically: by setting the "Trigger counter" function. With this func-
tion, the user specifies the number of successfully triggered spontaneous breaths
after which the apnoea ventilation mode will be terminated and the selected
ventilation mode resumed.
D
C
B.6 Setting alarm limits

Several alarms with variable alarm limits are available for adequate monitoring of
the patient's ventilation and of the ventilator. The alarm limits must be regularly
checked and adapted to the patient's condition if necessary.
Open the menu with the "Alarms" button. The menu is divided into ventilation
and sensor alarms. Select the alarm limit that you would like to change. Adapt the
value by using the selector and confirm your entry with the Enter key.
If you would like to cancel the entry, press the button of the selected parameter
once again or close the selector with the Alpha key.

B.7 Overview of alarm limits

B.7.1 Ventilation alarms
MV max Upper alarm limit for the expiratory minute volume
MV min Lower alarm limit for the expiratory minute volume
Vt max Upper alarm limit for the expiratory tidal volume
Vt min Lower alarm limit for the expiratory tidal volume
Criterion for the "Leakage High" alarm.The percentage describes the leak-
Leakage
age rate which is calculated from the total values (100 x (TVi-TVe)/TVi).
Plimit Maximum peak airway pressure
Pmin Minimum pressure within a breath
PEEPmax Upper alarm limit for the measured PEEP
PEEPmin Lower alarm limit for the measured PEEP
Fmax Upper alarm limit for the measured respiratory rate
Fmin Lower alarm limit for the measured respiratory rate
Fmax_spontan Upper alarm limit for the measured spontaneous respiratory rate
Fmin_spontan Lower alarm limit for the measured spontaneous respiratory rate
Pmean Upper alarm limit for the measured mean airway pressure
Pplateau max Upper alarm limit for the measured plateau pressure
Pressure limitation. Once the pressure limit has been reached no further
Pmax pressure adjustments are carried out so that the set tidal volume may no
longer be applied.
Criterion for apnoea alarm The criterion will be deemed fulfilled if, within
the set period since the end of the last inspiration, a new inspiration was
Apnoea Alarm
not detected.
Apnoea alarm ≤ Apnoea vent.
Criterion to start apnoea ventilation. The criterion will be deemed fulfilled
if, within the set period since the end of the last inspiration, a new inspira-
Apnoea Vent.
tion was not detected.
Apnoea Vent. ≥ Apnoea alarm
Depending on the selected configuration, the alarm limit for the

Remark maximum peak airway pressure PLimit can be set manually or it is
linked with the Pinsp setting and adjusted automatically.

B.7.2 Sensor alarms

Upper alarm limit for the inspiratory oxygen concentration. The difference
between the alarm limit and set inspiratory oxygen concentration (O2) is
+ O2 max maintained if the O2 value changes. The alarm criterion can be switched off
at the upper end of the adjustment range. In this case, the "O2 limit values?"
message appears.
Lower alarm limit for the inspiratory oxygen concentration. The difference
between the alarm limit and set inspiratory oxygen concentration (O2) is
- O2 min maintained if the O2 value changes. The alarm criterion can be switched off
at the lower end of the adjustment range. In this case, the "O2 limit values?"
message appears.
etCO2 max Upper alarm limit for the expiratory CO2 concentration
etCO2 min Lower alarm limit for the expiratory CO2 concentration
inCO2 max Upper alarm limit for the inspiratory CO2 concentration

Drug nebulization | C
C Drug nebulization
C.1 Intended use 204

C.2 Drug nebulization 204
C.2.1 Pneumatic nebulization 204
C.2.2 Mesh nebulization 207

C | Drug nebulization
C.1 Intended use

When the nebulizer function is used, the patient receives medical aerosol via the
breathing circuit during ventilation.
Depending on the configuration of the device, it is possible to nebulize medication

by means of a pneumatic nebulizer or a mesh nebulizer.
Depending on the set O2 concentration, the nebulizer operates with AIR or with
O2:
O2 concentration < 60% = operation with AIR
O2 concentration ≥ 60% = operation with O2
Algorithms are implemented to compensate variations in the inspiratory oxygen

concentration during pneumatic drug nebulization.
Observe the intended use of the elisa 800 instructions for use and the instruc-
tions for use of the nebulizer used.
C.2 Drug nebulization

or the mesh nebulizer. Both drug nebulization methods are available for each
selected patient category and in each ventilation mode.
C.2.1 Pneumatic nebulization

The nebulizer sets used for pneumatic drug nebulization should meet the follow-
ing minimum requirements:
• Nebulizer flow between 4 and 12 l/min at a supply pressure of 130 kPa

• Pressure-stable up to a breath pressure of 80 mbar
• Leakage under 200 ml/min at an airway pressure up to 50 mbar
The tested nebulizer sets are listed in the "elisa 800 accessories
Remark
list".
In case of drug nebulization procedures requiring a defined aer-

Remark osol output and/or a defined particle size distribution, the manu-
facturer of the nebulizer set must be contacted.
The components are intended for single use in order to prevent
Remark
cross-contamination.

To achieve the best possible application of oxygen, volume and pressure during
nebulization, the pneumatic nebulizer set should be included in the system test
before use. This helps achieve an almost complete compensation for all parame-
ters.
If the system test is performed without the nebulizer, the nebulizer data of the last
system test are used to calculated the compensation.
Fill the medication chamber of the nebulizer set according to the

Remark
manufacturer's specifications. Observe the maximum filling level.
Integrate the nebulizer set as described in chapter "4.7.1 Connection of the pneu-
matic nebulizer set".
When the nebulizer is switched on, no HME filters or bacteria fil-

ters should be used between the nebulizer and the patient. There
Warning is a risk of increasing the airway resistance.
Nebulized aerosols can be deposited in the expiratory flow sen-

sor and can have a severe impact on the measuring accuracy. A
bacteria filter in front of the expiratory valve can protect the
Caution flow sensor.
Check the proper functioning of the nebulizer set used. The ven-
tilator does not monitor the nebulizer function.
Warning
Open the menu for configuration of the drug nebulization function with the nebu-
lizer symbol (A) in the patient configuration area.

Select the pneumatic nebulizer in the menu. The application time is adjustable
between 5 and 60 minutes or the nebulizer can operate continuously ("cont." for
"continuously).
Start the pneumatic nebulization procedure by selecting the "On"
button and confirm with the Enter key. During active nebulization
the remaining nebulization period is shown in the nebulizer symbol.
Once the set application time has been reached, the nebulizer
switches off automatically. It can be deactivated manually at any time
(by pressing the button again). If you stop the drug nebulization pro-
cedure, the nebulizer symbol in the patient configuration area is
dimmed.
Synchronisation
The nebulizer function is synchronised with the inspiratory flow at respiratory
rates ≤ 25 /min.
The nebulizer is permanently active at respiratory rates > 25/min.
In spontaneously breathing patients, the respiratory rate can fluctuate around a

value of 25/min. In order to prevent frequent switching between inspiratory syn-
chronised and permanent nebulization, the device will analyse three consecutive
breaths to determine whether they were above or below the value of 25/min.
Pneumatic nebulization and O2 concentration

The nebulizer is operated with air at a set oxygen concentration (FiO2) ≤ 60 %
and with oxygen at a concentration > 60%.
The oxygen concentration of the inspiratory flow and the byflow are adapted
such that the set oxygen concentration (FiO2) at the Y-connector is guaranteed
within a tolerance range of +/- 4%.
If the pneumatic nebulizer is switched on, the Instant View window no longer
shows the measured FiO2 value but rather the value calculated at the Y-connector.
In this case the colour coding of the display field is hidden.

C.2.2 Mesh nebulization

Using the connection cable, connect the inhalation unit to the serial mesh nebu-
lizer interface on the back of the ventilator.
Only use approved inhalation units!

Caution
Integrate the inhalation unit as described in chapter "4.7.2 Connection of the

mesh nebulizer".
Use a syringe with an attached cannula to fill in the medication.

Remark
The maximum volume is 8 ml.
In case of drug nebulization procedures requiring a defined aer-

Remark osol output and/or a defined particle size distribution, the manu-
facturer of the inhalation unit must be contacted.
The selected medication must be approved by the manufacturers

for this type of mesh nebulizer application.
Caution
When the nebulizer is switched on, no HME filters or bacteria fil-

ters should be used between the nebulizer and the patient. There
Warning is a risk of increasing the airway resistance.
First connect the mesh nebulizer to the power supply before it

Warning
Be sure to connect the mesh nebulizer to the appropriate inter-

face on the back of the device. Secure the connector with the
Warning screws.
Select the mesh nebulizer from the menu. The application time is adjustable be-
tween 5 and 60 minutes or the nebulizer can operate continuously ("cont." for
"continuously).

Start the mesh nebulization procedure by selecting the "On" button

and confirm with the Enter key. During active nebulization the re-
maining nebulization period is shown in the nebulizer symbol.
Once the set application time has been reached, the nebulizer
switches off automatically.
It can be deactivated manually at any time (by pressing the button
again). If you stop the drug nebulization procedure, the nebulizer
symbol in the patient configuration area is dimmed.
Synchronisation
The nebulizer function is synchronised with the inspiratory flow at respiratory
rates ≤ 25 /min
The nebulizer is permanently active at respiratory rates > 25/min.
In spontaneously breathing patients, the respiratory rate can fluctuate around a

value of 25/min. In order to prevent frequent switching between inspiratory syn-
chronised and permanent nebulization, the device will analyse three consecutive
breaths to determine whether the respiratory rate is above or below the value
of 25/min.
After its activation, check the function of the mesh nebulizer. Fur-
thermore, elisa 800 monitors the mesh nebulizer. Please refer
to chapter "11 Alarms and troubleshooting" for alarm message
Warning details.

Capnometry | D
D Capnometry
D.1 Intended use 210

D.2 Measuring principle 210
D.3 Power supply 210
D.4 Breathing circuit 210
D.4.1 Respiratory gas humidification 211
D.4.2 Drug nebulization 211
D.5 Capnometry 211
D.5.1 Zeroing of the CO2 sensor 212
D.5.2 CO2 measurement 213
D.5.3 Trigger 214
D.5.4 Leakage compensation 214
D.6 Alarms 215
D.6.1 Alarm limits 215
D.6.2 Status light of the CO2 sensors 215

D | Capnometry
D.1 Intended use

With the following CO2 sensors, the functionality of the elisa 800 intensive care
ventilator can be expanded by CO2 monitoring of the respired gases.
• Main stream CO2 sensor IRMA CO2

• Side stream CO2 sensor ISA CO2
Observe and adhere to the intended use of the elisa 800

Remark instructions for use and the instructions for use of the CO2
sensor.
D.2 Measuring principle

The CO2 sensor sends infra-red light of a specific wavelength through the respira-
tory air. The absorbed portion of transmitted light is determined with a light-sen-
sitive detector and the end-tidal CO2 concentration is calculated from it.
D.3 Power supply

Both types of CO2 sensors (main and side stream) are powered via the serial
interface.
If the main power supply fails, the sensor continues to be powered from the elisa
800 unit as long as the elisa 800 battery maintains the ventilation function.
D.4 Breathing circuit

The CO2 sensors are compatible with all approved breathing circuits (also refer
to chapter "3.1 General safety instructions").
Integrate the CO2 sensor as described in chapter "4.8 Capnometry".
When using a side stream CO2 sensor, you can choose between sampling tubes
with Luer-Lock connectors (such as on the HME filter) or with a tube adapter
(e.g., for combination with heated tubing systems). The respective sampling tube
is first connected to the gas inlet of the side stream CO2 sensor and then to the
corresponding connection in the breathing circuit.
D.4.1 Respiratory gas humidification

Capnometry | D
The CO2 sensors can be combined with active and passive humidifiers.
The use of heated tubes is recommended when using the main

Remark
stream CO2 sensor with an active humidifier.
D.4.2 Drug nebulization
Drug nebulization and CO2 measurement must not be performed

at the same time!
Warning
D.5 Capnometry
Open the menu for configuration of the CO2 sensor by pressing the CO2 icon (A)
in the patient configuration area.
Set the number of breaths for averaging of the etCO2 value. Switch on the CO2
sensor and confirm your selection with the Enter key.
The system automatically detects the sensor type: main stream or

side stream. During measurement of the CO2 concentration, the icon
is presented in a different colour and the set number of breaths for
averaging is shown.

D | Capnometry
Remark The CO2 sensor is disabled during non-invasive ventilation.
First connect the CO2 sensor to the power supply before it

Warning
Be sure to connect the CO2 sensor to the appropriate interface

on the back of the device. Secure the connector with the screws.
Warning
D.5.1 Zeroing of the CO2 sensor

Calibration with ambient air is recommended before use. To do so connect the
side stream sensor with the measuring line or place the main stream sensor on
the measuring cuvette.
After a warm-up phase of 15 seconds, the "Zero Adjust" button in the "CO2 Sen-
sor" menu will be enabled and the sensor can be zeroed.

Capnometry | D
A ventilated patient must not be connected while the sensor is

being zeroed.
Warning
Main stream method:

For zeroing, no CO2 is allowed in the ventilation system.
Warning
Side stream method:

It must be ensure that the ambient air inlet of the CO2 sensor is
positioned in a well ventilated location.
Warning Avoid breathing in close proximity to the sensor during zeroing.
Side stream method:

Remark During long-term applications, the side stream CO2 sensor auto-
matically performs zero adjustments at least once every 24 hours.
If the CO2 sensor is connected at the time of the system test, its
Remark function is tested and a zero adjustment is automatically carried
out.
D.5.2 CO2 measurement

After the zero adjustment, the end-expiratory CO2 concentration (end tidal) is
constantly measured and shown along with the associated alarm limits in the
Instant View window. At the same time the CO2 curve is superimposed on the
volume curve.

D | Capnometry
The end-tidal CO2 concentration will be displayed in the unit

Remark
(mmHg, vol%, kPa) selected at the configuration level.
The CO2 measurement can be terminated by switching off the CO2 sensor in the
appropriate menu.
D.5.3 Trigger
When using the side stream CO2 sensor, the flow requirement of the CO2 sensor
should be borne in mind in case of very small flow trigger values (values < 1 l/min)
(see manufacturer's specifications for sample flow rate).
D.5.4 Leakage compensation

Leakage compensation of the intensive care ventilator can fully compensate the
gas used by the side stream CO2 sensor.

D.6 Alarms
D.6.1 Alarm limits
The following alarm limits are available for an adequate monitoring of the CO2
measurement:
etCO2 max Upper alarm limit for the expiratory CO2 concentration
etCO2 min Lower alarm limit for the expiratory CO2 concentration
inCO2 max Upper alarm limit for the inspiratory CO2 concentration
D.6.2 Status light of the CO2 sensors

The CO2 sensors each have a status light which indicates the following system
statuses:
Green System OK
static
Green Zeroing in progress
flashing
Red Sensor problem
static
Red Check adapter or sample line
flashing
Distributor: Manufacturer:
Heinen + Löwenstein SALVIA medical GmbH & Co. KG
Arzbacher Straße 80 Niederhöchstädter Str. 62
56130 Bad Ems, Germany 61476 Kronberg, Germany
Tel.: +49 26 03 96 00 0 Tel.: +49 6173 9333 0
Fax: +49 26 03 96 00 50 Fax: +49 6173 9333 29
www.hul.de www.salvia-medical.de
Instructions for Use elisa 800 | Language: English | Item no.: CM-929851 | Rev.: 10 | 30th of August 2016
© 2016 SALVIA medical GmbH & Co. KG | All rights reserved. Subject to technical changes.

Elisa 800: Instructions For Use

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Elisa 800: Instructions For Use

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Instructions for Use

Ventilator unit 08XX1234

Instructions for Use elisa 800 | SW 1.05.x | Rev. 10 3

4 Instructions for Use elisa 800 | SW 1.05.x | Rev. 10

Instructions for Use elisa 800 | SW 1.05.x | Rev. 10 5

11.4 Alarm messages during power-on self-test 132

6 Instructions for Use elisa 800 | SW 1.05.x | Rev. 10

B.3.9 Flexible BiLevel 178

Instructions for Use elisa 800 | SW 1.05.x | Rev. 10 7

- This page is intentionally left blank. -

8 Instructions for Use elisa 800 | SW 1.05.x | Rev. 10

1 About this manual

1.1 About this manual 10

Instructions for Use elisa 800 | SW 1.05.x | Rev. 10 9

1.1 About this manual

elisa 800 | Intensive care ventilator | Software version 1.05.x

1.2 Safety information in these instructions for use

Refers to dangerous situations which may occur when failing to

"Warning" refers to a situation which may cause injuries to the

10 Instructions for Use elisa 800 | SW 1.05.x | Rev. 10

2.1 Intended use 12

Instructions for Use elisa 800 | SW 1.05.x | Rev. 10 11

2.1 Intended use

2.2 Areas of application

The ventilator must not be used:

• in close proximity to nuclear magnetic resonance equipment

12 Instructions for Use elisa 800 | SW 1.05.x | Rev. 10

3 General safety instructions

3.1 General safety instructions 14

Instructions for Use elisa 800 | SW 1.05.x | Rev. 10 13

3.1 General safety instructions

Patients connected to the device require continuous surveillance by specialist

Keep a manual resuscitation bag ready to be able to continue

Do not reuse components intended for single use.

14 Instructions for Use elisa 800 | SW 1.05.x | Rev. 10

Classification according to EN 60601-1 Medical electrical equipment - General

DEVICE OF PROTECTION CLASS I, with internal power supply. Protection

Always connect type BF equipment to the device before connect-

Be sure to connect the equipment to the appropriate interfaces

APPLIED PARTS that conduct patient gases:

CONTINUOUS OPERATION if applied in compliance with the INTENDED USE

Instructions for Use elisa 800 | SW 1.05.x | Rev. 10 15

indicated in chapter 14 "Technical specifications".

Risk of electromagnetic disturbance

elisa 800 must not be used in close proximity to nuclear magnetic

16 Instructions for Use elisa 800 | SW 1.05.x | Rev. 10

Detailed information on electromagnetic compatibility can be

3.1.1 Safety standards

Instructions for Use elisa 800 | SW 1.05.x | Rev. 10 17

3.1.2 Safety functions

For a list of all alarm messages during the power-on self-test,

Alarms were implemented in the ventilator as safety functions in order to warn

Device alarms Monitoring

18 Instructions for Use elisa 800 | SW 1.05.x | Rev. 10

All device alarms are evaluated during ventilation, in standby

Patient alarms Monitoring

Patient alarms are only evaluated during ventilation and

Never carry out a system test while a patient is connected to

Instructions for Use elisa 800 | SW 1.05.x | Rev. 10 19

3.1.3 Work carried out on the device

Do not work on the device while a patient is being ventilated.

20 Instructions for Use elisa 800 | SW 1.05.x | Rev. 10