Ventilador Zoll 731
Ventilador Zoll 731
Ventilador Zoll 731
Operators Guide
Models: EMV+, AEV, Eagle II
731 Series
906-0731-01 Rev. G
The issue date for the ZOLL Portable Critical Care Ventilator Operators Guide (REF 906-0731-01 Rev. G)
is February, 2017.
Copyright 2015 ZOLL Medical Corporation. All rights reserved. ZOLL, AEV, EMV+, Eagle II and
Smart Help are registered trademarks or trademarks of ZOLL Medical Corporation in the United States and/or
other countries. All other trademarks are the property of their respective owners.
Masimo Pulse Oximeter
This device uses Masimo SET technology to provide continuous pulse oximeter and heart rate monitoring and
is covered under one or more of the following U.S.A. patents: 5,758,644, 5,823,950, 6,011,986, 6,157,850,
6,263,222, 6,501,975 and other applicable patents listed at www.masimo.com/patents.htm.
0123
Table of Contents
List of Figures
Set-up................................................................................................................................ 2-23
External Gas Sources ............................................................................................... 2-24
Ventilator Circuits: Connections ................................................................................ 2-26
Ventilator Circuits: Patient Connections .................................................................... 2-27
Ventilator Circuits: Resistance, Compliance, and Deadspace .................................. 2-28
Operating Power Selection and Stopping ................................................................. 2-29
Power Supply Connections ....................................................................................... 2-30
Self-Check ................................................................................................................ 2-31
Transducer Calibration (AUTO CAL) ........................................................................ 2-31
Pulse Oximeter Principles ................................................................................................. 2-32
Chapter 3 Operation
Overview ............................................................................................................................. 3-1
Introduction ................................................................................................................. 3-1
Pulse Oximeter ........................................................................................................... 3-2
Operation ............................................................................................................................ 3-3
Modes of Operation .................................................................................................... 3-3
Additional Adjuncts of Operation ................................................................................. 3-4
Spontaneous/Assisted Breath Trigger ........................................................................ 3-6
To Begin Ventilating .................................................................................................... 3-7
To Change Settings .................................................................................................... 3-8
Back Up Ventilator ...................................................................................................... 3-9
Pulse Oximeter ........................................................................................................... 3-9
Humidification ............................................................................................................. 3-9
Hazardous Environment Filters......................................................................................... 3-11
Bacterial/Viral Filter Use ........................................................................................... 3-11
Chemical/Biological Filter Use .................................................................................. 3-12
Check Valve on Breathing Circuit when in Hazardous Environments ...................... 3-12
Harsh Environment Operation........................................................................................... 3-13
Airborne Particulates ................................................................................................. 3-13
Extreme Temperature Environments ........................................................................ 3-13
Altitude ...................................................................................................................... 3-14
Rain and Snow .......................................................................................................... 3-14
Use of Low Flow Oxygen .................................................................................................. 3-15
Use In an MRI Environment .............................................................................................. 3-18
Chapter 4 Alarms
Smart Help Messages......................................................................................................... 4-2
Alarm Priorities ............................................................................................................ 4-3
Ventilator Alarm Categories ................................................................................................ 4-4
731 Series Ventilator Alarms............................................................................................... 4-9
Patient Alarms ............................................................................................................. 4-9
Device Alarms ........................................................................................................... 4-11
Environmental Alarms ............................................................................................... 4-22
Chapter 5 Maintenance
Calibration Checks.............................................................................................................. 5-1
General Cleaning ................................................................................................................ 5-2
Preventative Maintenance .................................................................................................. 5-2
Removable Foam Filter Replacement ................................................................................ 5-2
Fresh Gas/Emergency Air Intake Disk Filter Replacement................................................. 5-3
Internal Filter Change/Insertion .......................................................................................... 5-4
Post-Contaminated Environment Cleaning......................................................................... 5-6
Battery Maintenance ........................................................................................................... 5-7
Battery Capacity ......................................................................................................... 5-7
Battery Care and Charging ......................................................................................... 5-7
Internal Battery Change/Insertion ............................................................................... 5-9
Recharging Guidelines ............................................................................................. 5-10
Troubleshooting ................................................................................................................ 5-11
Operator Correctable Problems ........................................................................................ 5-11
Operating Problems Requiring Service ............................................................................ 5-11
Storage ............................................................................................................................. 5-11
Appendix A Specifications
General ...............................................................................................................................A-1
Pulse Oximeter ...................................................................................................................A-3
IEC 60601-1........................................................................................................................A-4
Appendix B Accessories
Index
Unpacking
Carefully inspect each container for damage. If the shipping container or cushion material is
damaged, keep it until the contents have been checked for completeness and the instrument has
been checked for mechanical and electrical integrity. If the contents are incomplete, if there is
mechanical damage, or if the ventilator does not pass its electrical self-test, U.S.A. customers
should call ZOLL Medical Corporation (1-973-882-1212). Customers outside of the U.S.A.
should contact the nearest ZOLL authorized representative. If the shipping container is
damaged, also notify the carrier. If there is no apparent sign of mechanical damage, read
instructions contained within this manual before attempting operation.
Assembly
The unit only requires that the operator attach the breathing circuit to begin ventilation using
either internal or external power. Both the ventilator and breathing circuit are supplied clean
and are ready for use on a patient.
The units batteries may not be installed within the unit (depending on the contractual
requirements or the storage environment as described in the Battery Care and Recharging
section). Battery installation may be required prior to operation.
Off
On
Mute / Cancel: Identifies button which mutes the active alarms or cancels
the parameter selection.
Alarm Bell Outline: Identifies alarm limit settings; Identifies the on-screen
alarms.
Symbol Description
Conventions
This guide uses the following conventions:
Within text, the names and labels for physical buttons and softkeys appear in boldface type (for
example, Press the CONFIRM/SELECT button).
This guide uses uppercase italics for text messages displayed on the screen
(for example, LEAD FAULT).
Warning! Warning statements alert you to conditions or actions that can result in personal injury
or death.
Caution Caution statements alert you to conditions or actions that can result in damage to the unit.
Abbreviations
A/C- Assist/Control I:E- Inverse ratio
ATPD - Atmospheric Temperature and Pressure Dry MRI- Magnetic Resonance Imaging
CPU- Central Processor Unit psig - Pounds per Square Inch Gage
Features
Portable critical care ventilator that can be used in the hospital, aeromedical and ground
transport, mass casualty situations, and extreme environments.
Multiple modes of ventilation for use with acute or chronic respiratory failure in both
intubated and non-intubated patients.
Intuitive operator interface minimizes operator training and protects existing settings from
inadvertent contact and manipulation.
Lightweight (~9.7 lbs, ~4.4 kg) provides for easy transport.
Rechargable battery provides over 10 hours of operation (at factory default with pulse
oximeter operating).
Operating temperature range from -25 to 49C (ZOLL validated testing) and from 10C to
40C (SGS listed).
Altitude compensation from -2,000 to 25,000 ft.
Self-contained system able to operate with or without external oxygen.
Gas manifold design allows operation with both high and low-pressure oxygen sources. All
oxygen is delivered to the patient breathing circuit.
Sealed gas path with chemical/biological filter connected to assure safe breathing gas
supply.
Sealed case and control panel protects components from weather and fluids.
Smart Help messages guide the operator through on-screen commands when responding to
alarms.
Warnings
General
Electric shock hazard: Do not remove equipment covers except to replace the batteries. An
operator may only perform maintenance procedures specifically described in this manual.
Refer servicing to ZOLL or an authorized ZOLL Service Center in the repair of this
equipment.
The device is intended for use by qualified personnel only. The operator should read this
manual, all precautionary information, and specifications before using the device.
Possible explosion hazard if used in the presence of flammable anesthetics or other
flammable substances in combination with air, oxygen-enriched environments, or nitrous
oxide.
During operation, the unit should not be stacked on top of or under other medical equipment
due to the possibility of electromagnetic interference between the unit and other equipment.
Before using on a patient, the operator should observe the device in its normal configuration
to assure that EMC interference between equipment is not occurring. (The unit was
subjected to EMC testing in accordance with Military Mil-STD-461F, Commercial IEC
60601-1-2, and FDA Reviewers Guidance specification.)
The equipment set up should not prevent this device from being disconnected from the
mains power in an emergency.
The use of accessories and cables other than those specified, with the exception of
accessories and cables sold by ZOLL as replacement parts for internal components, may
result in increased emissions or decreased immunity of this device.
Note: The operator should be aware that this device needs special precautions regarding
EMC and needs to be installed and put into service according to the EMC
information provided in this document.
The operator should be aware that portable and mobile RF communication equipment may
affect the performance of this device. The EMC test specifications for this device are
located in the Specifications section of this operators guide.
This equipment/system may cause radio interference or may disrupt the operation of nearby
equipment. It may be necessary to take mitigation measures, such as re-orienting or
relocating of the device or shielding the location.
The protection against defibrillation depends on the use of accessories (including pulse
oximeter) that are specified by ZOLL.
Grounding:
Connect the unit only to a three-wire, grounded, hospital-grade receptacle. The
three-conductor plug must be inserted into a properly wired three-wire receptacle;
if a three-wire receptacle is not available, a qualified electrician must install one in
accordance with the governing electrical code.
Do not under any circumstances remove the grounding conductor from the power
plug.
Do not use extension cords or adapters of any type. The power cord and plug must
be intact and undamaged.
If there is any doubt about the integrity of the protective earth conductor
arrangement, operate the oximeter on internal battery power until the AC power
supply protective cover is fully functional.
To ensure patient electrical isolation, connect only to other equipment with electronically
isolated circuits.
Do not use anti-static or conductive hoses or tubing with this device.
Do not connect to an electrical outlet controlled by a wall switch or dimmer.
As with all medical equipment, carefully route the ventilator circuit hose and tubing, patient
cabling, and external power cables to reduce the possibility of patient entanglement or
strangulation.
Pulse Oximeter
A pulse oximeter should not be used as an apnea monitor.
A pulse oximeter should be considered an early warning device. As a trend towards patient
deoxygenation is indicated, blood samples should be analyzed by a laboratory co-oximeter
to completely understand the patients condition.
Measurements: if the accuracy of any measurement does not seem reasonable, first check
the patients vital signs by alternate means and then check the pulse oximeter for proper
functioning.
Inaccurate measurements may be caused by:
Incorrect sensor application or use.
Significant levels of dysfunctional hemoglobin (e.g. carboxyhemoglobin or
methemoglobin).
Intravascular dyes such as indocyanine green or methylene blue.
Exposure to excessive illumination, such as surgical lamps (especially ones with a
xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, or
direct sunlight (exposure to excessive illumination can be corrected by covering the
sensor with a dark or opaque material).
Excessive patient movement.
Venous pulsations.
Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter,
or intravascular line.
The pulse oximeter can be used during defibrillation, but the readings may be
inaccurate for a short time.
Interfering Substances: carboxyhemoglobin may erroneously increase readings. The level of
increase is approximately equal to the amount of carboxyhemoglobin present. Dyes, or any
substance containing dyes, that change usual arterial pigmentation may cause erroneous
readings.
Alarms: Check alarm limits each time the pulse oximeter is used to ensure that they are
appropriate for the patient being monitored.
Loss of pulse signal can occur in any of the following situations:
The sensor is too tight.
There is excessive illumination from light sources such as a surgical lamp, a
bilirubin lamp, or sunlight.
A blood pressure cuff is inflated on the same extremity as the one with an SpO2
sensor attached.
The patient has hypotension, severe vascoconstriction, severe anemia, or
hypothermia.
There is arterial occlusion proximal to the sensor.
The patient is in cardiac arrest or is in shock.
Sensors:
Before use, carefully read the LNCS sensor directions for use.
Use only Masimo oximetry sensors for SpO2 measurements. Other oxygen
transducers (sensors) may cause improper performance.
Tissue damage can be caused by incorrect application or use of an LNCS sensor
for example, by wrapping the sensor too tightly. Inspect the sensor site as directed
in the sensor Directions for Use to ensure skin integrity and correct positioning
and adhesion of the sensor.
Do not damage LNCS sensors. Do not use an LNCS sensor with exposed optical
components. Do not immerse the sensor in water, solvents, or cleaning solutions
(The sensors and connectors are not waterproof). Do not sterilize by irradiation,
steam, or ethylene oxide. See the cleaning instructions in the directions for reusable
Masimo LNCS sensors.
Cautions
The circuit should be inspected every day to ensure that there is no damage or wear that
could affect its performance. Fluid or other biological material should be removed from the
circuit or the circuit should be replaced following the local standard of care.
Federal law restricts this device to sale by or on the order of a physician.
Service is to be performed by qualified biomedical equipment technicians only.
Internal components are susceptible to damage from static discharge. Do not remove device
covers.
Possession or purchase of this device does not convey any expressed or implied license to
use the device with unauthorized sensors or cables which would, alone, or in combination
with this device fall within the scope of one or more of the patients related to this device.
ZOLL cannot ensure the proper functioning of this device if it is used with unauthorized
sensors or cables.
Software License
Note: Read this Operators Guide and License agreement carefully before operating any of
the ZOLL ventilator products.
Software incorporated into the system is protected by copyright laws and international
copyright treaties as well as other intellectual property laws and treaties. This software is
licensed, not sold. By taking delivery of and using this system, the Purchaser signifies
agreement to and acceptance of the following terms and conditions:
1. Grant of License: In consideration of payment of the software license fee which is part of
the price paid for this product, ZOLL Medical Corporation grants the Purchaser a
nonexclusive license, without right to sublicense, to use the system software in object-code
form only.
2. Ownership of Software/Firmware: Title to, ownership of, and all rights and interests in the
system software and all copies thereof remain at all times vested in the manufacturer, and
Licensors to ZOLL Medical Corporation and they do not pass to purchaser.
3. Assignment: Purchaser agrees not to assign, sublicense, or otherwise transfer or share its
rights under the license without the express written permission of ZOLL Medical
Corporation.
4. Use Restrictions: As the Purchaser, you may physically transfer the products from one
location to another provided that the software/firmware is not copied. You may not disclose,
publish, translate, release, or distribute copies of the software/firmware to others. You may
not modify, adapt, translate, reverse engineer, decompile, crosscompile, disassemble, or
create derivative works based on the software/firmware.
NO IMPLIED LICENSE
Possession or purchase of this device does not convey any express or implied license to use the
device with replacement parts which would, alone, or in combination with this device, fall
within the scope of one or more of the patents relating to this device.
Limited Warranty
ZOLL warrants the device to be free from all defects in material and workmanship for a period
of one (1) year from the date of delivery to the original purchaser.
During the warranty period, ZOLL will repair or replace the device or any part which upon
examination is shown to be defective. At its sole discretion, ZOLL may choose to supply a new
or equivalent replacement product or refund the amount of the purchase price (on the date sold
by ZOLL). To qualify for such repair, replacement, or refund, the defective device must be
returned to the ZOLL Service Center within thirty (30) days from the date that the defect is
discovered. This warranty does not apply if the device has been repaired or modified without
the authorization of ZOLL or if the damage was caused by incorrect (off-label) use, negligence,
or an accident.
Batteries, which by their nature are consumable and subjected to environmental extremes, will
be warranted only for a period of ninety (90) days. Accessories, also consumable in usage, such
as connecting hose and breathing circuits, are not warranted.
DISCLAIMER OF IMPLIED & OTHER WARRANTIES:
THE PRECEDING WARRANTY IS THE EXCLUSIVE WARRANTY AND ZOLL
MAKES NO OTHER WARRANTY OR REPRESENTATION OF ANY KIND
WHATSOEVER, EXPRESS OR IMPLIED, WITH RESPECT TO MERCHANTABILITY,
FITNESS FOR A PARTICULAR PURPOSE, OR ANY OTHER MATTER. THE
REMEDIES STATED IN THIS DOCUMENT WILL BE THE EXCLUSIVE REMEDIES
AVAILABLE TO THE CUSTOMER FOR ANY DEFECTS OR FOR DAMAGES
RESULTING FROM ANY CAUSE WHATSOEVER AND WITHOUT LIMITATION.
ZOLL WILL NOT IN ANY EVENT BE LIABLE TO THE CUSTOMER FOR
CONSEQUENTIAL OR INCIDENTAL DAMAGES OF ANY KIND, WHETHER FOR
DEFECTIVE OR NONCONFORMING PRODUCTS, BREACH OR REPUDIATION OF
ANY TERM OR CONDITION OF THIS DOCUMENT, NEGIGENCE, OR ANY OTHER
REASON.
When requesting service, please provide the following information to the service
representative:
Unit serial number
Description of the problem
Department using the equipment and name of the person to contact
Purchase order to allow tracking of loan equipment
Purchase order for a unit with an expired warranty
The ZOLL Critical Care ventilator is designed to manage infant through adult patients with
acute or chronic respiratory failure or during resuscitation by providing continuous
positive-pressure ventilation. (See Indications of Use)
The ventilator comes in five models:
EMV+
EMV+ MRI
Eagle II
Eagle II MRI
AEV
Common Features
Rugged design
Weight: ~10 lbs
10 hour battery life
Rapid charger to achieve 90% battery capacity in 2 hours
Pressure and volume ventilation modes: AC, SIMV with or without PS, CPAP with or
without PS, with and without NPPV/PPV
Pressure support
Leak compensation
High performance internal compressor
PEEP control
Smart Help messages
Masimo SET Measure through Motion
Low-Perfusion Pulse Oximetry
Integral SpO2
Airworthiness Release
Daylight visible display
906-0731-01 Rev. G ZOLL Portable Critical Care Ventilator 2-1
PRODUCT OVERVIEW
Oxygen efficient
Supports infant, pediatric, and adult patients
Limited 1 year warranty
EMV+
The EMV+ ventilators rugged design makes it ideal for use in emergency vehicle and air
transport of patients. It has a wide range of ventilation modes, such as AC, SIMV with or
without PS, and CPAP with or without PS with NPPV-PPV.
EMV+ Ventilator
AEV
The AEV ventilator is built for managing ventilator support patients during ambulance
transport. Its ventilation modes (AC, CPAP with PS and NPPV) are specifically chosen to be
consistent with pre-hospital care providers operating procedures.
AEV Ventilator
Eagle II Ventilator
6.
8.
7.
9.
10.
2. Status Indicator LED Array Lights up to indicate status of the unit, connected to alarms
3. External Power Input Connector Connects the unit to an external power source
4. USB Connector Connects the unit to a USB drive or USB compatible device
6. Fresh Gas/Emergency Air Intake Allows the units internal compressor to take ambient air and acts as an
anti-asphyxia valve
7. LCD Display Displays the units settings, patient data, and alarm information
10. Battery Compartment Contains the units rechargable lithium ion battery
Pneumatic Diagram
The following image is a diagram of the ZOLL ventilators pneumatic design.
Pneumatic Diagram
PULSE
PRESSURE)
OXIMETER
CONNECTOR
EXHALATION
VALVE
FRESH
GAS/EMERGENCY
AIR INTAKE
Connector Panel
The connector panel for the ZOLL ventilator unit has the following components:
Oxygen Input -- connects the unit to the output of an appropriate oxygen regulator attached to
a medical-grade (USP) oxygen cylinder. The OXYGEN IN fitting has a male oxygen Diameter
Index Safety System (D.I.S.S.) thread. A green (white in some installations), 6 foot long
high-pressure oxygen hose with compatible fittings that provides for connection between the
unit and the oxygen source is required. (Also see Harsh Environment Operation section).
Note: If external oxygen is connected, the gas pressure must be at least 41-psig ( 2 psig)
when SELF-CHECK is performed.
Gas Output -- connects to the ventilator circuit 22 mm ID corrugated hose. The connector is a
22 mm male conical connection.
Fresh Gas/Emergency Air Intake -- allows ambient air into the units internal compressor.
The port also functions as the internal anti-asphyxia valve, which allows the patient to breathe
ambient air in the event of a ventilator failure. The intake contains a particulate filter and
permits the operator to connect either a bacterial/viral or a chemical/biological filter depending
on ambient conditions.
Transducer (Patient Airway Pressure) -- connects to the ventilator circuit 3/16 ID
transducer tubing. The barb-type connector is colored a green/blue to distinguish it from the
other connectors.
Note: The 3/16 ID ventilator circuit transducer tubing is a green/blue (darker) color.
Exhalation Valve -- connects to the ventilator circuit 1/4 ID exhalation valve tubing.
The barb-type connector is clear anodized aluminum to distinguish it from the other connectors.
Note: The 1/4 ID ventilator circuit exhalation valve tubing is clear.
External Power Input -- accepts DC voltage between 12.5 and 28 volts (negative ground).
The input mates with the output connector plug of the AC/DC Power Supply, 12 and 28 VDC
Power Cables (both are available as accessories) or the external battery.
USB Connector -- connects the unit to a USB drive or any USB compatible device.
Pulse Oximeter Connector -- connects the unit to a pulse oximeter sensor probe.
The Control Panel incorporates all controls and the LCD display. The controls consist of
buttons, a Power Off/On switch, and a Rotary Encoder that we describe in the following
section. Context Menu controls are shown in tables associated with their parameter button.
1. HR -- Pressing the HR button highlights the High Heart Rate alarm limit and enables its
value to be changed. Pressing the HR button a second time will highlight the current value
of the Low Heart Rate Alarm limit and enable its value to be changed. The HR parameters
are functional only when the pulse oximeter is connected. Both limits are adjustable by
1 b/min. The default value at start up for the high alarm limit is 120 b/min; the low alarm
Note: PIP values greater than 60 cm H2O require the operator to perform a separate
confirmation.
5. VT (Tidal Volume) -- In volume targeted modes, pressing the VT button highlights the
current set tidal volume and enables it to be changed. In pressure targeted breaths, the
delivered tidal volume is shown as outlined text and is based on the patient pulmonary
mechanics. The VT High and Low Limits are also available as secondary parameters.
Note: In the CPAP-NPPV, the VT delivered and Vmin may be overestimates of the true
volume going to the patient when leaks are present. The O2 Use values will accurately
display the O2 use though the amount used will be more than if no leak was present.
Warning! If significant leaks are present during CPAP-NPPV, the VT delivered and Vmin shown
may be overestimates of what is actually being delivered to the patient. The adequacy of
ventilation should be assessed using an alternate method.
6. BPM (Breaths Per Minute) -- Pressing the BPM button highlights the current breathing rate
and enables it to be changed. Secondary parameters include high breath rate, low breath rate,
and I:E ratio, which can be adjusted by pressing the Parameter button the appropriate number
of times. During CPAP operation, the patients actual breathing rate is displayed as the BPM
primary parameter in outlined text.
BPM Context Menu
Menu Item Range Description
Control Parameter I:E, TI Allows operator to select independent variable
Rise Time 1 to 10 Determines the speed of the rise flow: low
values fast rise, high values low rise
Cycle Off% 10 to 70% (default 25%) Allows operator to adjust Cycle Off%
Control Parameter -- the operator can select which parameter is dependent or independent.
Selecting I:E results in the ventilator maintaining the I:E Ratio while the Inspiratory time
(TI) varies when the breathing rate is changing. Selecting TI maintains a constant
Inspiratory time while the I:E ratio varies when the rate is changed.
Rise Time -- the unit allows the operator to adjust the time it takes to reach the full
respiratory flow and peak Inspiratory pressure during pressure targeted breathing and when
pressure support is being used. The range is 1 to 10 where 1 is the shortest rise time and 10
is the longest rise time. When the unit is turned on, either the default Rise Time or a User
Rise Time will be used. Using the Pressure-Time waveform as reference will assist the
operator in setting the Rise Time.
The Rise Time settings should be reassessed and adjusted after the patient is placed on the
ventilator and initially stabilized. To minimize patients work of breathing and potential for
pressure overshoots, operators must take the following into consideration when setting the
Rise Time:
Patients respiratory pattern
Patients comfort
Patients flow demand
Resistance (Mechanical/Physiological)
Compliance characteristics
The Rise Time for a passive lung is driven primarily by airway resistance, and is fairly
independent of compliance.
Resistance Rise Time
5 1
20 3
50 5
200 10
An adult patient with high Resistance may benefit from a Rise Time setting of 3 to 4 for
optimal breath delivery. Rise Times of 8-10 are optimized for infants and are flow limited.
(The infant circuit is not intended for flows > 60 LPM.)
Cycle Off% -- the unit allows the operator to adjust the Cycle Off%. The primary purpose
of this parameter is to set a fraction of peak flow at which inspiration ends and exhalation
begins. A key application for Cycle Off% is to adjust for leaks present in and around the
patient circuit or the patient themselves.
Note: The longest duration of a spontaneous pressure supported breath is limited to 5
seconds. At the end of this time, the ventilator ends flow and opens the exhalation
valve. (All other breaths are time cycled.)
Cycle Off% is principally made available as a parameter for NPPV mode, where a
much higher setting is required to cycle the breath properly in the presence of a
leak. If a higher value is not used and there is a leak, the tendency will be for the
system to time cycle at 5 seconds instead of flow cycle. This is due to the fact that
the leak flow might be higher than 25% of the peak flow, so the cycle threshold is
never crossed.
If there is no leak, increasing the Cycle Off% will cause breaths to cycle sooner,
thus delivering less volume. If it is set too high, the breath will end early relative to
patient effort and may lead to the triggering of a second breath.
Note: Clinicians must carefully assess the patients response to the Cycle Off%
application and must carefully adjust the flow cycle setting to optimize patient
ventilatory support and comfort.
7. Mode -- Pressing the MODE button will highlight the current ventilation mode. Pressing the
Parameter button again will allow for the selection of volume or pressure targeting which is
shown as either (V) for volume or (P) for pressure. Selecting volume assures a constant
volume is delivered to the patient in the inspiratory time using a constant flow. Pressure
targeting ventilation provides a constant airway pressure for the duration of the inspiratory
time using a decelerating flow pattern. See Additional Modes of Operation for a
When going into Apnea Back Up from CPAP in the EMV+ and Eagle II (NPPV and
PPV), and in the AEV (NPPV only), the unit will automatically return to Pressure with the
following back up settings:
PIP Target BPM I:E OR TI
20 12 1:2.5 OR 1.42
All other parameters will remain as they were previously set. When leaving CPAP, the new
operating mode will be Pressure Targeted and will use Apnea Back Up settings as the new
settings.
Caution These Apnea Back Up settings are appropriate for an adult. For pediatric and infant patients, the
operator should adjust the Apnea Back Up settings so they are appropriate for the patient.
(the highlight moves from the parameter variable back to the parameter label). For
parameters with multiple options, pressing CONFIRM/SELECT opens a submenu where
the various parameters are selected using the ROTARY ENCODER and changed using the
process described above. At any point, the operator can cancel an operation, return to the
previous menu level, or exit the menu control by pressing the MUTE/CANCEL button.
1. Alarm Configuration -- allows the operator to disable the audible and visible alarm
alerts associated with specific alarm in order to prevent nuisance alarms. While the
menu shows all of the alarms that can be disabled, the system only allows you to disable
active alarms. This approach assures that the operator has been advised of the alarm and
has decided that it does not affect safe and effective management of the patient. It is
important to recognize that Low Priority alarms are Advisory and the patient and device
are performing as configured, but there is information that could affect management of
the patient.
2. Power Up Settings -- allows the operator to select startup settings different from the
factory defaults. The menu allows the operator to select the current ventilator settings for
use at startup. There are 3 options: default, user 1, and user 2. User 1 and user 2 allow the
operator to establish different startup settings based on the intended patient population.
ZOLL is constantly focused on providing clinically safe, effective and timely support to
patients requiring ventilator support as well as ease of use to their care providers. The
initial focus and area for application of the unit platform is Acute Patient Care in many
varied and austere environments. This patient area of need has historically been the
Adult range of patients. ZOLL has used this historical data and experience as
its rationale for the unit to start-up in the Adult patient Assist-Control Volume mode and
associated parameters which have been deemed as clinically safe and acceptable starting
points and limits by international experts and standards committees.
ZOLL also strives to provide user-friendly options to our customers and allow them to
set up certain USER Start-up selected modes after their acquisition of the equipment as
they know best what their patient base and needs for mechanical ventilatory support are
within their respective region or facilities. Realizing that varied levels of need and
experience exist, as well as knowing that each patient is different and clinician
assessment is required prior to application to the patient, certain mode and parameter
configurations are not available as User setup options in an effort to maximize patient
safety.
To configure startup settings other than the default, press the MENU button, select
POWER UP SETTINGS; select SAVE SETTINGS and select either user 1 or user 2
and press CONFIRM/SELECT. To start with the new setting, select POWER UP
WITH and select which user setting you would like to use at startup and press
CONFIRM/SELECT. Assure the proper startup setting by turning the ventilator off
then on again. The unit will being operation with the new settings. Limits for stored
parameters are shown on the table below. Default startup modes are limited to AC and
SIMV (SIMV available for EMV+ and Eagle II only); CPAP cannot be stored as a
stored default.
Parameter Limitations
VT Setting 1000 ml
VT High Limit 10ml resolution, only recalled if the target is pressure or in SIMV(V)
VT Low Limit 10ml resolution, only recalled if the target is pressure or in SIMV(V)
Target (P or V) No limit
BPM 6 to 60
I time No limit
PEEP No limit
Caution The operator should set the PIP Low Limit to be at least PEEP + 5. This is to reduce the
likelihood of not detecting a kinked hose. If the PIP Low Limit is set > PEEP and < PIP, the PIP
Low Limit can also serve as a PEEP compensated disconnect threshold.
3. Pulse Oximeter -- allows the operator to turn the pulse oximeter on or place it in standby.
4. Trigger Lever -- allows the operator to adjust the assisted breath trigger from -6 to -0.5
cm H2O to optimize the patient/ventilator interaction; the default value is -2 cm H2O
below baseline. The setting is not retained when the device is powered off.
Caution The operator should take care in setting the trigger level so as to minimize work of breathing and
prevent auto-triggering. Ventilating infants and other patients with weak inspiratory effort, the
trigger threshold should be reduced (>-2 cm H2O) to reduce the work required for the patient to
trigger a breath. During NPPV with a large leak, the trigger threshold may need to be increased
to prevent auto-triggering with the variable baseline pressure.
5. O2 Reservoir -- allows the operator to tell the device that the 3-liter O2 Reservoir
Assembly is in use. Using the reservoir can cause a Fresh Gas Intake Fault alarm to occur.
Turning this function on disables this alarm and prevents nuisance alarms. The device is
still able to detect and alarm if the Fresh Gas/Compressor Intake is blocked and the
compressor is not able to deliver its contribution to the breath. Operation in extremely
high vibration environments can also trigger this alarm. Using this mode in these
situations can reduce nuisance alarms. The setting is not retained when the device is
powered off.
6. Unit Info -- lists the serial number for the unit and Smart Pneumatic Module (SPM),
software version, hours of use, and last calibration date.
A. Date: the current date (day/month/year), based on the time and date when the
calibration was performed.
B. Cal date: displays the date of the last calibration.
C. Hours of Op: displays the hours of operation since the last calibration.
D. EMV Soft Rev: displays the ZOLL ventilator software revision that is in use with
the device.
E. EMV SN: displays the serial number of the ZOLL ventilator.
F. SPM Soft Rev: displays the SPM software revision that is in use with the device.
G. SPM SN: displays the serial number of the SPM.
H. EMV Model: displays the model number of the EMV portion of the ZOLL
ventilator.
Display Screen
A. HR -- Displays the HR and Low/High HR alarm limits. A heart icon is also displayed in this
window when the pulse oximeter is in use. The icon flashes in sequence with the patients
heart rate. Immediately to the left of the HR and SpO2 parameter windows is the pulse
oximeter pleth display. When no alarms are present, the pleth is displayed. When alarms
occur, the pleth is removed to allow room for the alarm name and mitigation instructions.
When a Low priority alarm is muted, the pleth is returned to the screen. For all priority
alarms, the LED indication lights remain active even if the alarm information is not shown
on the screen.
B. SpO2 -- Displays the SpO2 and Low/High SpO2 alarm limits.
C. FIO2 -- Displays the set fraction of inspired oxygen. The window also displays the O2 Use
value.
D. PIP -- Displays the peak airway pressure, PEEP, and Low/High PIP alarm limits. During
volume targeted ventilation, the PIP is displayed as outlined text to remind the operator that
it is dependent on the set volume and patients respiratory mechanics.
E. VT -- Displays the set tidal volume during volume targeted ventilation. During pressure
targeted ventilation, it displays the delivered tidal volume. This is indicated by the outlined
text and by displaying (Del) next to VT. In pressure targeted ventilation, the Low/High tidal
volume alarm limits are displayed.
F. BPM -- Displays the set breath rate, the Low/High breath rate alarm limits, and either the
I:E ratio or inspiratory time (depending on the operator configuration). During operation in
CPAP, the BPM primary parameter is the patients actual breathing rate in outlined text.
G. Mode -- Displays the operating mode and the breath target (V) for volume or (P) for
pressure. The upper right corner of this window also displays if the unit is in the NPPV
adjunct (Noninvasive Positive Pressure Ventilation) or the default PPV adjunct (Positive
Pressure Ventilation).
H. Status Indicator LED Array -- The Status Indicator LED Array contains green, yellow,
and red LEDs. During normal operation, the Status Indicator LED Array is enabled.
Green -- Indicates operating power and that all ventilator and patient parameters
are operating as intended.
Yellow -- Indicates that a Low Priority alarm has been detected or that a persistent
alarm condition is active. The unit will continue to operate within its safety limits
while the yellow LED provides a constant reminder that although it was
acknowledged, the condition remains.
Red -- Indicates High and Medium Priority alarm conditions. The Alarm LED
flashes when the alarm occurs.When the MUTE/CANCEL button is pushed, the
LED illuminates continuously during the 30 seconds that the audible alarm is
muted during Medium Priority alarms. Pressing the MUTE/CANCEL button
during High Priority alarms has no effect.
I. Pulse Pleth/Time Plot -- Displays the pulse pleth waveform if no medium/high priority
alarms are displayed.
J. Pressure/Time Plot -- Displays the PIP versus time plot if no medium/high priority alarms
are displayed. The numbers indicate the PIP readings, and are not displayed when the PIP is
above/below the PIP limits. This pressure information is to assist both in diagnostic
evaluation and in setting the rise time.
Note: When no alarms are present, the pulse pleth/time and pressure/time plots are
displayed. When alarms occur, the plots are removed to allow room for alarm name
and mitigation instructions. When a low priority alarm is muted, the plots are
returned to the screen. For all priority alarms, the LED indication lights remain
active even if the alarm information is not shown on the main screen.
K. Current Mode -- Displays the current Mode plus any adjuncts that are in effect (for
example, CPAP + NPPV, AC(Volume) etc.) The pressure value for the pressure support (PS)
is indicated by the number (cm H2O) in parenthesis after PS (for example, PS (40)).
O. Speaker (Mute or Unmute) Icon/Indicator -- Indicates whether the alarm sound has been
muted or is active. The Muted speaker icon is present during the startup 2 minute mute, with
the remaining muted time indicated under this icon.
O. Head with Mask Icon/Indicator -- Indicates if the NPPV adjunct is in effect for ventilatory
support of spontaneously breathing patients. This icon replaces the Unmuted Speaker and/or
the Muted Speaker icon for Low priority alarms. (This icon does not appear if a Medium
priority alarm has been muted.)
P. Alarm Triangle Icon/Indicator -- Indicates if there is an active alarm. The priority of the
alarm is indicated by the interior of the triangle: empty for Low priority, one exclamation
point for Medium priority, and two exclamation points for High priority.
Q. Airway Pressure/Measured Values -- Provides a continuous display of airway pressure. Its
absolute range is from -10 to 100 cm H2O ATPD with a horizontal resolution of 1cm
H2O/pixal. The scale below the indicator is graduated in 10 cm H2O increments with
numerical markers appearing at 0, 50, and 100 cm H2O. Above the bar graph, measured
values for delivered minute volume, mean airway pressure (MAP), and actual breathing rate
(set plus spontaneous) are displayed.
Pop Up messages
To prevent setting of unwanted or inadvertent parameter values that are outside the typical
clinical range of settings, the unit presents Pop Up messages that ask the operator if they are
sure they would like to set the parameter beyond the typical range. When a message occurs, the
operator is asked to press the CONFIRM/SELECT button before they can adjust a parameter
beyond the typical range. Pop Up messages are also used to alert the operator that certain
settings are not permitted. In addition, Pop Up messages can call for the operator to
CONFIRM/SELECT that they are entering configurations where certain alarms are being
suppressed, turned off, and/or cancelled.
BPM LIMIT CONFLICT Cannot adjust high limit lower than low limit
BPM LIMIT CONFLICT Cannot adjust low limit higher than high limit
HEART RATE LIMIT CONFLICT Cannot adjust high limit lower than low limit
HEART RATE LIMIT CONFLICT Cannot adjust low limit higher than high limit
HIGH VT LIMIT SETTING Confirmation required-press accept key for values above
1500ml
LOW BREATH RATE SETTING Confirmation required-press accept key for values below 6
BPM
PEEP BACKUP SETTING Cannot adjust PEEP target to within 5 of backup PIP target
CONFLICT
PEEP SETTING CONFLICT Cannot adjust PEEP target to within 5 of PIP High Limits
PEEP SETTING CONFLICT Cannot adjust PEEP target to within 5 of PIP target
PEEP SETTING CONFLICT PEEP + PS cannot be greater than PIP High Limit
PIP LIMIT BACKUP SETTING Cannot adjust high limit lower than backup PIP target
CONFLICT
PIP LIMIT CONFLICT Cannot adjust high limit lower than low limit
PIP LIMIT CONFLICT Cannot adjust high limit lower than PIP target
PIP LIMIT CONFLICT Cannot adjust high limit lower than PS + PEEP
PIP LIMIT CONFLICT Cannot adjust low limit higher than high limit
PIP SETTING CONFLICT Cannot adjust PIP target higher than PIP High Limit
PIP SETTING CONFLICT Cannot adjust PIP target to less than 5 more than PEEP
REQUESTED O2 FLOW TOO Reduce FIO2, increase BPM, reduce I Time, or increase VT
LOW
TOTAL REQUESTED FLOW TOO Cannot exceed 100 LPM total flow
HIGH
TOTAL REQUESTED FLOW TOO Cannot flow less 2 LPM total flow
LOW
VT LIMIT BACKUP SETTING Cannot adjust high limit lower than Backup VT Setting
CONFLICT
VT LIMIT BACKUP SETTING Cannot adjust low limit higher than Backup VT Setting
CONFLICT
VT LIMIT CONFLICT Cannot adjust high limit lower than low limit
VT LIMIT CONFLICT Cannot adjust low limit higher than high limit
Warning! Always assure that there is an alternate means of providing ventilation. A bag-valve
resuscitator and an appropriate mask for the patient being ventilated should be
immediately available.
Warning! This units USB connection does not provide any signal output or input to the operator.
It is for the use of ZOLL-trained personnel only. The operator should not connect
anything to the USB connection.
Warning! Never block the Fresh Gas/Emergency Air Intake. A free flow of air is required during
compressor operation or in the event of a device failure to allow spontaneous breathing.
The Fresh Gas/Emergency Air Intake also acts as an anti-asphyxia port in the event of a
ventilator failure.
Caution Always dispose of the circuit after single patient use following the institutional guidelines for
biologically contaminated material. Reusing the circuit can result in cross contamination
between patients.
Adult 40 60
Pediatric 12-50 30
Infant 5-12 5
ZOLL provides four ventilator circuits depending on patient size and longer length required for
MRI operation, as indicated in the following table:
Warning! Adult patients should only be ventilated with Pediatric/Adult circuits. Infant patients
should only be ventilated with Infant/Pediatric circuits.
Pediatric patients can be ventilated with either the Pediatric/Adult or Infant/Pediatric circuits.
However, ventilation of Pediatric patients in the higher weight range (30-40 kg) with
Infant/Pediatric circuits requires gas flows that result in noisy operation. There is no patient risk
to this noise, except that it could disturb the patient and distract the operator. To avoid this
noise, the recommended Pediatric patient weight ranges for use with the various circuits, and
the corresponding Resistance and Compliance measurements, are indicated in the following
table:
Warning! If circuits with different resistance/compliance are used or additional adjuncts are
placed in line with the circuit, the operator must make sure that the appropriate circuit
resistance/compliance factors for the new circuit are used as well as dead space volume
of the added adjunct(s) is/are factored into the equation for effective tidal volume
delivery to the patient.
Caution When using the standard vehicle DC outlet, the vehicle should not be jump started during
operation of the ventilator.
Warning! Never start the ventilator with the patient connected. Always start the ventilator, select
the patient settings, ensure operation, and then connect the patient. Always manually
ventilate the patient when they are not connected to the ventilator.
The unit is designed to use external power when available rather than its internal battery pack.
When an acceptable external power source is present, the internal battery pack is automatically
charged while the unit operates. When an external power failure occurs, the unit automatically
switches to its internal battery pack for operating power and activates the EXTERNAL POWER
FAILURE alarm; there is no interruption in operation and/or loss of any alarms. When external
power returns, operating power automatically switches from internal power to the external
source. In the event that the device needs to be shutdown, the procedure consists of turning the
POWER switch to the OFF (O) position. If this fails to work or puts the patient or operator at
possible risk, the device should be disconnected for the mains power.
Caution Do not twist the power cable connection plug. Pinch the plug and slide up to release the safety
latches. Failure to do so may damage the power connection plug and prevent it from functioning.
Warning! If the power supply, power cable, or power connection plugs are damaged or become
damaged during use, immediately disconnect the power cable from external power and
the power supply assembly.
Warning! Until the operator has determined that the ventilator is functioning properly and that
the ventilator parameters are set correctly for the patient, the patient should not be
connected to the ventilator.
Pulse Oximeter
At start up, the pulse oximeter is in standby (pulse oximeter on and ready to monitor) and the
parameter windows for SpO2 and Heart Rate read stby and operational alarms are suppressed.
As soon as a valid patient signal is detected 10 seconds, the pulse oximeter comes out of
standby, a pulse search is performed to obtain the optimum signal and then the parameters are
displayed, and all alarms are active. The pulse oximeter can be turned on via the Pulse
Oximeter submenu in the main menu by changing stby to On. Similarly, if the probe is
removed from the patient and monitoring is no longer desired, the pulse oximeter can be placed
back in standby via the Pulse Oximeter menu submenu. See the Pulse Oximeter Principles
section and the Pulse Oximeter section of Specifications.
The pulse oximeter and its accessory probes and cables are intended for continuous
noninvasive monitoring of arterial hemoglobin (SpO2) and pulse rate (measured by the SpO2
sensor) for adult, pediatric and infant patients using the appropriate sensor for the patient. The
pulse oximeter is operational in all ventilator modes when its cable and sensor are properly
attached to the SpO2 connector.
To operate the pulse oximeter, connect the probe to the patient cable and the patient cable to the
SpO2 connector on the unit. The monitoring function will continuously display the patients
pulse rate and SpO2 value. See the Pulse Oximeter Alarms in the Ventilator Alarm Categories
section for more information on pulse oximeter alarms.
Note: The pulse oximeter can only be placed in standby when the probe is disconnected from
the patient. A valid signal will automatically bring the pulse oximeter out of standby.
The pulse oximeter reading can be affected by the following conditions:
1. The sensor is too tight.
2. There is excessive illumination from light sources such as a surgical lamp, a bilirubin
lamp, or sunlight.
3. A blood pressure cuff is inflated on the same extremity as the one with a SpO2 sensor
attached.
4. The patient has hypotension, severe vascoconstriction, severe anemia, or hypothermia.
5. There is an arterial occlusion proximal to the sensor.
6. The patient is in cardiac arrest or is in shock.
Modes of Operation
The unit offers a range of modes using both pressure and volume targeting that can be selected
to optimally manage the patient.
Assist/Control (AC) -- The patient receives either controlled or assisted breaths. When the
patient triggers an assisted breath, they receive a breath based on either the volume or pressure
target.
Synchronized Intermittent Mandatory Ventilation (SIMV) -- The patient receives
controlled breaths based on the set breathing rate. Spontaneous breaths can be either
unsupported demand flow or supported using Pressure Support. (This mode is not available in
the AEV unit.)
Continuous Positive Airway Pressure (CPAP) -- The patient receives constant positive
airway pressure while breathing spontaneously. Spontaneous breaths can be either demand flow
or supported using Pressure Support.
EMV+, Eagle II: The default CPAP provides positive end-respiratory pressure with
and without Pressure Support. The operator has the option of adding leak compensation
(NPPV) if desired to support the patient. The minimum baseline pressure (PEEP) in
CPAP-NPPV is 3 cm H2O regardless of the Pressure Support setting.
AEV: Only provides for CPAP with leak compensation (NPPV) with or without Pressure
Support. The minimum baseline pressure (PEEP) in CPAP-NPPV is 3 cm H2O regardless
of the Pressure Support setting.
Note: In the SIMV(P), SIMV(V), and CPAP modes, the sum (PEEP + PS) must be 3 cm
H2O.
Note: In transitioning from AC to either CPAP or SIMV, if the starting PEEP value is 3 cm
H2O or less, the PEEP shall be set to 3.0 cm H2O during the transition. (This is to
assure that there is never a situation when both the PS and PEEP are zero, which would
violate (PEEP + PS) 3 cm H2O.
Note: Negative pressure is not available in the expiratory phase.
Mode Breath Target Pressure Support (PS) Noninvasive Positive Pressure Ventilation (NPPV)
AC V&P No No
SIMV V&P Yes No (SIMV is not available in AEV)
CPAP N/A Yes Yes (CPAP-NPPV is Automatic in AEV)
Pressure Support (PS) -- Can be used to assist spontaneous breaths in both SIMV and CPAP
modes. To set pressure support, press and hold the PIP parameter button (while the mode is set
to either SIMV or CPAP), press the CONFIRM/SELECT button to highlight the PS value,
then turn the ROTARY ENCODER to the desired value. Once the desired value is selected,
press the CONFIRM/SELECT button to enable the value and then the MUTE/CANCEL
button to return to the main screen. The Current Mode display will denote the value of this
pressure support by the number (cm H2O) in parenthesis after PS (value).
Noninvasive Positive Pressure Ventilation (NPPV) -- Provides flow during the expiratory
phase to maintain the baseline pressure (CPAP) in spontaneously breathing patients with a
leaking airway or facemask. The amount of leak compensation depends on the leak flow rate
during the expiratory period and ranges from 0 to 15 liters/min and is automatically adjusted by
the ventilator in order to maintain the CPAP target. In the AEV model, the NPPV is
automatically in place when the CPAP mode is entered.
Caution The operator should take care in setting the VT alarms and trigger level. The trigger level should
be adjusted to minimize work of breathing and prevent auto-triggering. The VT alarms should
bracket average tidal volume so that pending respiratory failure (low tidal volumes) and
excessive leaks (high tidal volumes) are detected.
Caution The transition into NPPV automatically sets the rise time to 3, which may be too fast for infants
and small children. Before using with an infant or small child, the operator should always
configure the ventilator appropriately before attaching the patient.
Warning! In CPAP-NPPV, a VT that is lower than anticipated given the patients size may be an
indication that the patient is not able to adequately spontaneously ventilate.
To avoid nuisance alarms in patients with active leaks, operation using NPPV suppresses
certain alarms. The alarms which are suppressed are:
1. Incomplete Exhalation (Alarm #3091)
2. Insufficient Flow (Alarm #2095)
When the NPPV adjunct is in operation, the head with mask icon will appear in the location
used by the speaker/mute icons. Low and Medium priority alarms will cause this head with
mask icon to disappear. It will reappear when Low priority alarms are muted. When Medium
priority alarms are muted, the muted speaker icon will appear.
When transitioning to NPPV mode, the following parameters/alarm limits will automatically be
adjusted to the following default values:
Alarm/Parameter CPAP into NPPV Default Value
PEEP 5 cm H2O
Rise Time 3
When transitioning from the NPPV mode to another mode, the following parameters/alarm
limits will reset to the default values. This is done to assure appropriate monitoring in an active
ventilating mode:
Low Airway Pressure Alarm (PIP Target = -3) (PIP Target = -3)
Warning! Never use the CPAP with or without Noninvasive Positive Pressure Ventilation (NPPV)
adjunct on a patient that is NOT spontaneously breathing and/or may stop
spontaneously breathing. CPAP is intended for ventilatory support, NOT ventilation.
To Begin Ventilating
Procedure:
1. Attach the disposable patient circuit to the ventilator. If you wish to use a Heat and
Moisture Exchanger (HME), attach it to the patient connector of the ventilator circuit.
2. Attach the AC/DC Converter to an appropriate AC power source if available.
3. Turn the POWER switch on to initiate the Self Check and start the ventilator. When Self
Check is complete, operation will begin at default values.
Parameter Mode BPM VT PEEP FIO2 I:E High PIP Limit
Warning! Default settings are intended to provide basic support and prevent unintended injury.
Particular care should be taken to adjust the ventilator appropriately before ventilating
infants and children. The ventilator should always be adjusted before placing the
patient on the ventilator.
4. Allow at least one breath to occur; during this time, the PATIENT DISCONNECT alarm
will activate as the ventilator does not detect the minimum required airway passage.
5. Attach the ventilator circuit connector1 to the patients endotracheal tube, tracheostomy
tube, or other airway that supports positive pressure ventilation2. Delivery of the first
breath will automatically cancel the PATIENT DISCONNECT alarm.
Warning! Avoid high airway pressure as this increases the risk of aspiration.
Warning! Deadspace increases with mask ventilation; always follow the mask manufacturers
directions.
Warning! During pressure-targeted ventilation, always set the high tidal volume just above the
patients maximum tidal volume. In the event of disconnection or decannulation, the
alarm will activate indicating more volume is required to reach the set pressure target.
Warning! Always set the Low Airway Pressure Limit at least 5 cm H2O above PEEP. Ideally, the
value should be 5 cm H2O < PIP.
7. Start a record of the date, time, ventilator settings, power source, and patient status.
8. Check the patient and ventilator on a regular basis to assure adequate ventilation and
device performance. Listen for, and respond to, all alarms.
9. During transport, reassess the patient and ventilator at least every hour or whenever the
patient is moved. When operating on battery power, always monitor the battery charge.
To Change Settings
Each Parameter button of the unit is associated with a parameter window; each parameter
window has a primary parameter and as many as 3 secondary parameters that can be adjusted
by the operator based on the mode of operation and breath target. To adjust the primary
parameter, press the Parameter button one time; to adjust a secondary parameter, press the
Parameter button a second or third time. Each time you press the Parameter button, a different
parameter is highlighted in the parameter window. To change a primary or secondary
parameter, use the following sequence:
1. Press the Parameter button one or more times to select either the primary parameter or
secondary parameters.
2. With the appropriate parameter highlighted, turn the ROTARY ENCODER clockwise
or counterclockwise to raise or lower the value.
3. Press the CONFIRM/SELECT button switch to complete the value change.
3. If the accuracy of any measurements does not seem reasonable, first check the patients vital signs by
alternate means and then check the pulse oximeter for proper functioning.
Back Up Ventilator
The unit contains a built-in back up ventilator mode that is designed to provide a limited degree
of operation should certain types of failures occur to the primary operating system. Depending
upon the pre-existing conditions at the time of failure, the backup ventilator will begin
operation in one of two ways:
1. If no pre-existing alarm condition(s) exists: backup operation will continue using the
current settings.
2. If a pre-existing alarm condition(s) exists: backup operation will revert to the startup
default settings (Mode AC (P), volume target, BPM 12, PIP 20 cm H2O, FIO2 21%, PEEP
5 cm H2O, I:E 1:2.5, PIP High Limit 35 cm H2O).
Pulse Oximeter
The pulse oximeter and its accessory probes and cables are intended for continuous
noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and
pulse rate (measured by the SpO2 sensor) for infant through adult patients. The pulse oximeter
becomes operational in all ventilator modes when its cable and sensor are properly attached to
the SpO2 connector.
To operate the pulse oximeter, connect the sensor probe and the patient cable to the SpO2
connector on the top of the ventilator. The monitoring function initiates automatically when a
valid patient signal is detected for > 10 seconds. The operator can set low and high alarm limits.
If an alarm occurs, the operator can use this mitigation to assess the condition of the patient and
as an aid in determining what intervention is required.
Humidification
Heat and Moisture Exchangers (HMEs) can be used with the unit. While HMEs may not be
suitable for all applications, they facilitate portability in a way that conventional humidifiers
cannot. The unit can be used with an optional HME or an optional HME/bacterial viral filter
(HMEF). The HME provides heat and moisture to the inspired gas by recycling the head and
moisture contained in the patients exhaled gas. Use of an HMEF may help reduce the risk of
cross contamination of biological pathogens that might be transmitted in the patients exhaled
gas. HMEs or HMEFs attach between the disposable ventilator circuit and patients
endotracheal tube. Be sure to follow all instructions provided by the manufacturer.
The following table gives guidance on appropriate tidal volume range using various HMEs
with Adult, Pediatric, and Infant patients.
ZOLL does not offer a heated humidifier option for the unit. Users are cautioned to carefully
consider the ramifications of such use and the effect it may have upon device performance and
the patients comfort. Such humidifiers have been shown to increase the work of breathing in
portable ventilators4. Any humidification device should be connected and operated only in
accordance with directions provided by its respective manufacturer. Humidifiers are not
recommended for transport. Observe all safety and cautionary statements.
Warning! Use of the HME or HME/Bacterial Viral filter (HMEF) may not be indicated in patients
with small tidal volumes as the dead space may be greater that 25% of the set Tidal
Volume. Always select an HME/HMEF that is appropriate for the patient. For very
small tidal volumes (50 to 75 ml), it may be advisable to not use an HME.
Warning! Use of the HME or HME/Bacterial Viral filter (HMEF) will cause a slight increase in
the inspiratory effort to trigger an Assisted Breath (approximately 1 cm H2O).
Warning! Always monitor the patient and ventilator when using restrictive external filters or the
external O2 reservoir. Changing modes with these restrictions can cause false
compressor failure alarms under parameter configurations where high air flow is
required.
Warning! The Medical Control Officer and/or Incident Commander should determine which, if
any, external filter is used based on the potential hazard.
Warning! The operator must ensure that nothing blocks the inlet of the external filter; failure to
do so could prevent the patient from breathing and cause an ventilator failure.
Caution If filters have been exposed to biological matter, dispose of them following the Universal
Precaution procedures for your facility.
Warning! The unit is shipped with both the pediatric/adult and infant/pediatric single limb
circuits. A Check Valve (704-0700-01) is required with these breathing circuits when
operating in a hazardous environment. The correct mating of the Check Valve with the
breathing circuit is shown below. Operators who anticipate use in these environments
should also stock the Check Valve.
5. A 3M C2A1 canister (3M St. Paul, MN) was used in our validation testing to represent the class of filters
generically known as C2A1 under the NSN number 4240-01-361-1319. These tests confirmed the
performance of the ventilator when operating with these devices as a class. Use of the 3M canister does not
constitute endorsement or recommendation of the 3M device. Use and selection of the appropriate filter
should always be under the direction of the Incident Commander.
Airborne Particulates
Under normal operating conditions, the internal 2-stage filtration system protects the gas flow
path from particulates entrained through the Fresh Gas/Emergency Air Intake. However, when
operating in areas where fine dust or dirt is airborne due to wind or vehicle movement, the
operator should use a disposable bacterial/viral filter (sometimes called HEPA filter) to
preserve the internal filter. Use of these filters will prevent the operator from having to change
the internal filters. For extended operation in these environments, the operator should change
the filter as it becomes dirty (visually inspect the filter for dust/dirt build up). The primary
effect of entrained particles is on the operation of the flow pneumotach used to control the gas
delivered to the patient. Dirt on the pneumotach screens affects the calibration. Cleaning the
screens requires a biomedical technician to disassemble the device and ultrasonically clean the
screens. The best way to prevent taking the unit out of service is to use a filter in dusty
environments. In addition to using the filter, the operator can also keep the unit in the soft case,
which will protect the unit case and the LCD from becoming scratched or damaged. It is also
easier to clean the padded case following use in a dusty/dirty environment than the device.
Altitude
The unit is designed to operate from -2,000 to 25,000 feet (-610 to 7620 meters). An absolute
barometric pressure sensor monitors ambient pressure and this information is used to
continuously correct the output of the device to maintain the ventilation parameters. When the
altitude is > 25,000 feet, the unit activates a Low Priority alarm. When this occurs, the operator
should monitor the peak inspiratory pressure (PIP) and adjust the tidal volume to maintain the
PIP and monitor breath sounds and chest excursion to assure adequate ventilation is
maintained. The tidal volume increases as altitude increases, so the operator should look to
prevent over pressurization of the lung when the altitude increases beyond 25,000 feet. If
changes are made above 25,000 feet, the operator should revert to the initial settings once
operation resumes in the compensated range (the LED will turn from yellow to green).
Warning! The unit is not intended for hyperbaric operation. Use in a hyperbaric chamber can
result in harm to the patient and/or damage to the device.
Procedure
1. Press the MENU button and use the ROTARY ENCODER to select O2 Reservoir On.
This tells the unit that the reservoir is attached and prevents the FRESH GAS INTAKE
RESTRICTED alarm.
2. Attach the oxygen supply hose to the nipple on the reservoir assembly (see figure below).
3. Attach the O2 Reservoir Bag Assembly to the Fresh Gas/Emergency Air Intake as shown.
Warning! Always monitor the patient and ventilator when using restrictive external filters or the
external O2 Reservoir. Changing modes with these restrictions can cause false
compressor failure alarms under parameter configuration where high flow is required.
Note: The assembly will function when the reservoir bag is hanging down or lying
horizontally, provided the bag does not fall in such a way that closes the neck of the
bag.
Note: The ventilator will sound a Low priority FRESH GAS INTAKE RESTRICTED alarm if
the menu has not been changed (see #1 above). Operating with the alarm active does
not affect the ability of the ventilator to deliver breaths at the current settings. It is to
alert the operator that a restriction has been detected at the inlet.
4. Adjust the oxygen flow to achieve an acceptable oxygen saturation.
Note: Always allow 5 to 10 minutes between adjustments to assure the patient oxygenation
has stabilized. This is very important when delivering the oxygen supply where it may
several minutes for a patient to stabilize as the new oxygen flow.
Note: Never use oxygen flows greater than the patients consumption. Flows greater than this
may cause the baseline pressure to drift, waste oxygen, and may cause an
INCOMPLETE EXHALATION alarm.
Operating Notes
Note: When the reservoir is removed, be sure that the 22 mm adapter is removed with the
assembly.
Due to the slight difference between the densities of air and oxygen, the tidal volume will
decrease slightly as oxygen is entrained. The worst case is a < 10% decrease in tidal volume
when the entrained oxygen results in a FIO2 of 100%. The following tables show both effect on
tidal volume and the resultant FIO2 for various oxygen supply rates:
O2 Flow 0 1 2 3 4 5 6 7 8
l/min
FIO2 21 30 38 48 57 70 80 89 100
VT(set) 740 732 725 718 711 703 691 689 682
VT(actual) 700 692 685 678 671 663 651 649 642
O2 Flow 0 1 2 3 4 5 6
l/min
FIO2 21 30 43 56 69 89 100
O2 Flow 0 1 2 3 4 5 6
l/min
FIO2 21 32 47 62 76 96 100
Field of View 35 x 26 cm 35 x 26 cm
Slice Thickness 6 mm 4 mm
6. www.fda.gov A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems,
2/7/1997, R.A. Phillips & M. Skopec; www.ecri.org Use of equipment in the magnetic resonance (MR)
environment Health Devices, April 2005; www.acr.org ACR Guidance Document for safe MR Practices:
2007 AJR:188 June 2007, E. Kanal et al.; http://www.MRIsafety.com Dr. F.G. Shellock; http://
www.patientsafety.gov/alerts/MRI.doc MRI Hazard Summary August 2001, J. Gosbee and J. DeRosier,
VA National Center for Patient Safety.
Parameter 3.0 T
Echo Time, TE 20 ms 15 ms
Field of View 30 x 30 cm 30 x 30 cm
Slice Thickness 3 mm 3 mm
Flip Angle 90 20
Warning! Only ZOLL ventilators marked with an MRI conditional label should be used in the
MRI environment.
The four main MRI hazard concerns regarding the use of the ZOLL ventilator in an MRI
environment and their remediation are as follows:
Hazard Hazard Remediation
The static field effects interfere with the Operator warned to use a distance of 2 meters or
operation of the ventilator. more. (Test demonstrates this is not a problem
for operation at 2 meters.)
The ventilator could interfere with the MRI Operator warned to use a distance of 2 meters or
imaging and introduce image artifacts. more. (Test demonstrates this is not a problem
for operation at 2 meters.)
The ventilator, ventilator accessories, and/or cart Operator warned to use proper anchoring and
could feel magnetic attraction and become a not to stand between bore opening and unit/cart.
projectile missile hazard to both operator and the (Test demonstrates this is not a problem for
patient. operation at 1 meter.)
The pulse oximeter can heat up in the MRI Operator warned not to use the pulse oximeter.
environment due to induced current from the
magnetic field and result in possible burning of
the patient and/or the operator.
Only ZOLL ventilators marked with an MRI conditional label should be used in the MRI
environment.
The operator shall follow all safety procedures that are in effect for the MRI environment.
Failure to follow these ventilator/MRI instructions can result in the malfunction of the
ventilator, MRI artifacts, and/or possible injury to patient/operator.
The ventilator was successfully tested in a 3.0 T environment when placed behind the 2,000
gauss field line. ZOLL recommends placing the ventilator at least 2m or 6.6 from the
magnets bore opening.
The unit should not be used in an MRI environment which has > 3T magnetic strength.
The units power transformer shall not be brought into the MRI environment. The unit shall
operate on battery power only. The battery should be fully charged before bringing into the
MRI environment.
The units pulse oximeter cables shall not be brought into the MRI environment.
The unit shall be secured to a ZOLL MRI roll stand (Part #816-0731-01) or properly
secured to another suitable MRI compatible cart prior to entering the MRI environment.
Failure to do so could result in the unit becoming a missile projectile.
The ZOLL MRI roll stand shall be used with the IV arm (aluminum) only
(Part #704-0731-09). It shall not be used with the breathing circuit arm (ferrous). The cart
shall not have any other ferrous materials placed on it due to projectile missile danger.
The operator shall use only aluminum, non-magnetic oxygen cylinders, and oxygen
regulators.
The operator shall not use an active humidifier or humidifier holder/bracket in the MRI
environment. These could become projectile missiles.
At no time shall any person be permitted to be between the bore entrance and an unsecured
unit/roll stand, due to possible missile projectile danger.
When the roll stand is in place, the wheels shall be locked. If possible, it is recommended
that the stand be tethered in position.
The unit/roll stand shall be in place and secured in position before the patient is placed on
the scanner table and advanced into the bore. It is recommended that the unit/roll stand be
tested in the MRI environment prior to its use in patient support. If this is not possible, extra
care must exercised and the unit shall be removed if there is any sign of attractive force with
its potential projectile missile danger.
The patient shall be removed from the MRI environment before the unit/roll stand is
removed from the MRI environment.
The units screen shall be visually monitored for alarms at all times if there is a risk that
audible alarms will not be heard, for example during image acquisition.
The operator shall use only ZOLL MRI breathing circuits
(pediatric/adult Part #820-0130-00, infant/pediatric Part #820-0131-00) or other MRI safe
breathing circuits that will permit suitable separation between the unit and the bore opening
of the magnet.
Extended length of tubing can result in loss of volume due to additional compressibility.
Insure that the patient is receiving correct tidal volume when this circuit is used.
Do not use this circuit with PEEP settings below 5 cm H2O.
Given the additional length of the circuit, the system may not be able to trap PEEP with
patients with short expiratory times. Always assure the device is performing as required
before beginning MRI study.
The longer breathing circuits may affect the required settings of the vent from the settings used
with the shorter breathing circuits in a non-MRI environments.
Caution The use of longer breathing circuits may increase the risk of self-triggering of ventilator breaths.
Reducing the pressure trigger sensitivity may solve this problem.
Above is an illustration of what is seen if there are several alarms. The Alarm message refers to
the alarm bell that is dark. The Operator can cycle through the various alarms by turning the
ROTARY ENCODER. If there are less than 5 alarms, this alarm list will also include a plot
icon, where the alarm screen will be replaced by the Pulse Pleth/Time and Pressure/Time plots.
If the alarms are Low Priority, then muting these Low Priority alarms will cause the Pleth and
Pressure/Time plots to appear permanently on the screen. If the alarms are Medium Priority,
the unit will cycle through each Medium Priority Alarm for a 20 second period. The ROTARY
ENCODER can be used to select a particular Medium Priority Alarm and/or Plot for 20
seconds, after which the above cycling rotation will resume. New Alarms will overwrite the
screen at any time.
Alarm Priorities
Alarm priorities define the operational state of the device regarding it ability to provide
mechanical ventilation. The alarm priority determines what effect pressing the
MUTE/CANCEL button will have. There are three priorities:
High Priority: Mechanical ventilation under operator control is no longer possible. This
alarm category requires immediate intervention by the operator. This includes system failure
alarms where the CPU has failed and a backup has taken over to sound the audible and
visual alarms. It also includes when the device is turned on and there is no internal or
external power source. Pressing the MUTE/CANCEL button has no affect on the High
Priority alarm. The alarm can only be silenced by turning off the ventilator.
Medium Priority: Mechanical ventilation is active or is possible (maybe for a finite period
of time), but there is a failure/fault with the patient, ventilator circuit, a pneumatic
subsystem, or pulse oximeter. This alarm category requires immediate intervention by the
operator. Pressing the MUTE/CANCEL button mutes Medium Priority alarms for 30
seconds. If after 30 seconds the alarm-causing condition still exists, the audible alarm will
recur until it is muted again for another 30 second period or resolves.
Low Priority (Advisory): Safe mechanical ventilation is active, but there is a fault that the
operator must be aware of to ensure safe management of the patient and/or ventilator. Low
Priority alarms present with both an audible and yellow LED alarm signal alerting the
operator to the condition. Pressing the MUTE/CANCEL button cancels the audible signal.
If the alarm is not resolved, the yellow LED remains illuminated to remind the operator of
the fault or failure. Some Low Priority alarms may be canceled to avoid nuisance alarms.
Airway Pressure High: Triggered when the airway pressure exceeds the High Airway
Pressure Limit value for two consecutive breaths. Patient related causes for this Medium
Priority alarm are patient coughing, ventilator dissynchrony, or excess secretions in the
airway. Other causes include kinks in the ventilator circuit tubing or a High Airway Pressure
value that is too low given the airway pressure. The default value at start up is 35 cm H2O.
Pressing the MUTE/CANCEL button mutes the audible alarm for 30 seconds.
PEEP Not Met/Leak: Triggered when the ventilator detects a drift of more than 2 cm H2O
in the end expiratory pressure. This Medium Priority alarm is most often associated with a
loose or disconnected circuit hose or tube. The alarm can also be triggered when leaks are
present during noninvasive mask ventilation or when uncuffed endotracheal or
tracheostomy tubes are used. The operator should also check to make sure the exhalation
valve is firmly attached to the circuit and that the cap is securely attached to the body of the
assembly. Pressing the MUTE/CANCEL button mutes the audible alarm for 30 seconds.
Disconnect: Triggered when the peak airway pressure fails to go 5 cm H2O above the
baseline pressure before the end of the inspiratory phase. This Medium Priority alarm is
associated with disconnects between the patient port of the circuit and the patient airway. It
can also be caused by a loose or disconnected circuit hose or tube. Pressing the
MUTE/CANCEL button mutes the audible alarm for 30 seconds.
RTC Battery Fault/Failure: The voltage of the real-time clock (RTC) battery that powers
the memory that stores calibration and service information. The operator should take the
ventilator out of service when appropriate. A Low Priority alarm is sounded when RTC
battery voltage drops below the replacement threshold. Pressing the MUTE/CANCEL
button mutes the audible alarm, but the persistent message and yellow LED remain.
Calibration Due: This Low Priority alarm is triggered when the time since its last
calibration has passed its next due date. Pressing the MUTE/CANCEL button mutes the
audible alarm, but the persistent message and yellow LED remain.
Ambient Pressure Fault: Triggered when the ventilator senses that it is operating outside
of its designed ambient pressure range (-2,000 to 25,000 feet altitude). This Low Priority
alarm alerts the operator that there may be some effect on the delivered volume and to
monitor the airway pressure and breath sounds to assure adequate ventilation of the patient.
Pressing the MUTE/CANCEL button mutes the audible alarm, but the persistent message
and yellow LED remain.
Ambient Temperature Fault: Triggered when the ventilator senses that it is operating
outside of its designed temperature range (-25 to 50C). This Low Priority alarm alerts the
operator that there may be some effect on the delivered volume and to monitor the airway
pressure and breath sounds to assure adequate ventilation of the patient. Pressing the
MUTE/CANCEL button mutes the audible alarm, but the persistent message and yellow
LED remain.
SpO2 Sensor Off Patient: Triggered when the pulse oximeter detects that it is no longer
connected to the patient. The Medium Priority alarm alerts the operator to check the position
of the sensor, patient movement, and/or the perfusion at the sensor site. Pressing the
MUTE/CANCEL button cancels the alarm. To clear the alarm, reposition the sensor to a
better site or suspend SpO2 monitoring by placing it in standby (stby).
SpO2 Light Contamination: Triggered when the SpO2 signal is corrupted by an external
light signal. The Low Priority alarm alerts the operator that too much external light
(sunlight, surgical light, etc) is affecting the sensor. Pressing the MUTE/CANCEL button
cancels the alarm. To clear the alarm, shield the sensor from direct light using a cloth or
paper towel.
Unrecognized SpO2 Sensor: Triggered when the pulse oximeter detects connection with
an inappropriate sensor to the ventilator. The Low Priority alarm alerts the operator that the
attached probe is not designed to work with the pulse oximeter in the ventilator. Pressing the
MUTE/CANCEL button cancels the alarm. To clear the alarm, use an appropriate sensor or
suspend SpO2 monitoring by placing it in standby (stby).
Patient Alarms
Patient alarms are triggered by the actions or the condition of the patient.
Service Code Alarm Name/Mitigation/Resolution
2076 Apnea
The spontaneous breathing rate is less than the low alarm limit. This alarm only occurs in CPAP
and CPAP-NPPV.
Mitigation/Info: Apnea Backup Ventilation Started, Set Mode to AC or SIMV, Set Rate and Tidal
Volume/Pressure Target
**Manually Ventilate Patient**
1012 O2 Valve Failure (O2 Valve Signal Chain Fault - No Back Up)
The communication between the O2 Valve and the SPM fails and the compressor is not available to
provide ventilation.
Mitigation/Info: Manually Ventilate Patient
**Replace/Service Ventilator**
The compressor fails to operate or fails to provide the flow required to deliver a breath within 10%
of the current settings, HP O2 is available to provide ventilation and the operator has set the FIO2
to 100%.
Mitigation/Info: Assure 55 psig O2, O2 Operation Only!
**Replace/Service Ventilator**
Environmental Alarms
Environmental alarms are triggered by environmental conditions beyond the devices
operational limits or faults caused by outside forces.
Service Code Alarm Name/Mitigation/Resolution
3450 Battery Fault (Battery Nearly Too Hot For Discharge-w/External Power Connected)
The battery temperature reaches 70C (158F), which is 5C from its maximum operating
temperature and external power is connected. When the battery temperature reaches 75C
(167F), the battery will shut down to prevent failure. When this occurs, the unit will continue
operation using external power only.
Mitigation/Info: Battery Too Hot to Discharge, DO NOT Remove External Power!, Remove Padded
Case, Assure Ability to Manually Ventilate Patient, Shade Patient and Ventilator
**Move to Cooler Location**
3451 Battery Fault (Battery Too Hot For Discharge-w/External Power Connected)
The battery temperature reaches 75C (167F) and external power is connected. Discharging the
battery beyond this temperature could destroy the battery and damage the unit. During the alarm
condition, the unit will continue operation using external power only.
Mitigation/Info: Battery Too Hot to Discharge, DO NOT Remove External Power!, Remove Padded
Case, Assure Ability to Manually Ventilate Patient, Shade Patient and Ventilator
**Move to Cooler Location**
2076 Apnea
High Breath PIP Low VT High VT Low Low SpO2 High Heart Low Heart
Rate Rate Rate
Calibration Checks
Calibration checks should be done every 12 months or 1500 service hours, unless significant
usage warrants a shorter period between preventative maintenance inspections. The device
performs a calibration check as part of the start up routine when the device is powered on.
Following 6-months of continuous storage/non-use, or longer, this device should be examined,
operationally tested, and its batteries recharged before patient-use is attempted. A complete
calibration check should be made by a competent biomedical equipment technician at
12 month/1500 service hour intervals. Calibration checks should be performed as required and
the results recorded. A secure record of these calibration checks should be maintained for
devices not returned to ZOLL for calibration/maintenance. Calibration checks should also be
performed whenever the operator suspects that the unit is not functioning properly or following
mass deployment before the device is returned to storage. If the unit being tested fails the
calibration check, it should be returned to an authorized ZOLL Service Center or ZOLL for
calibration.
Contact an authorized ZOLL Service Center or ZOLL prior to returning this instrument for
scheduled maintenance, calibration, or service (Telephone: 1-973-882-1212,
email: www.zoll.com). A Returned-Goods-Authorization number (RGA #) will be issued. The
RGA # must appear on both the packing slip and address label. This will facilitate better
tracking of the returned item and result in improved scheduling and handling.
General Cleaning
Keep the unit and its accessories clean at all times. Never allow grease and/or oil to enter the
system or coat its components. Exposed parts should be dried following usage in wet
environments. Users are encouraged to clean this device and its accessories at regular intervals
and maintain up-to-date records of maintenance and inspections. Internal pneumatic
components are sealed, thus routine maintenance is not required. Pressure hose connections
should be wiped with a damp, soapy cloth and throughly dried with a lint-free cloth. The units
housing should also be cleaned as necessary with damp, soapy cloth and throughly dried with a
lint-free cloth. Do not clean with abrasives or chlorinated hydrocarbon cleansers.
Warning! Never use oil or grease of any kind with oxygen or compressed gas equipment.
Preventative Maintenance
Routine maintenance should be performed on this instrument at regular intervals and prior to its
being placed into service. Routine maintenance should consist of the following:
1. Storage -- make sure the ventilator is stored in a clean and dry environment.
2. Operational checks -- with the ventilator not connected to a patient, power cycle the
ventilator after every 1000 hours of use and using a ventilator circuit and test lung, operate
the ventilator at default settings, then change various settings and confirm proper operation,
test disconnect, airway pressure, and SpO2 alarms.
3. Tubing and hose checks -- replace crimped, cracked, or worn tubing and hoses as required.
4. Mechanical components are subject to wear and fatigue over time. Components will
deteriorate more quickly when used continuously. To insure compliance with operating
specifications, it is the users responsibility to insure that periodic preventative maintenance
is performed. It is recommended that the In-Field Calibration Check be performed by ZOLL
or a certified ZOLL service facility.
5. ZOLL recommends that on a daily basis, the operator examine the breathing circuit for
damage or wear including but not limited to cracking, discoloration, or disfigurement. If there
is any sign of physical degradation or the unit is indicating breathing circuit problems, the
operator should replace with a new breathing circuit.
Caution There are no user serviceable parts except the filter components above.
Caution When used in dusty/dirty environments, the foam and disk filters should be checked, and
replaced as needed. This will prevent particle build up on the transducer screen and the need to
take the unit out of service for maintenance by a biomedical technician.
Caution If filters have been exposed to biological matter, dispose of them following Universal Precaution
procedures for your facility.
Note: Do not attempt to clean this filter and do not operate internal compressor without a
filter in place.
Warning! Before attempting to replace filters, make sure that external power is disconnected and
the units Power Switch is set to OFF.
Procedures:
Foam Filter:
The Foam Filter is located inside the
Compressor Inlet Fitting.
Set the lower segment of the Compressor Inlet Fitting Assembly into the unit, making
sure that its alignment pin mates.
Shoulder
Alignment
Hole
Set the upper segment of the Compressor Inlet Fitting Assembly into the lower segment,
making sure that its alignment pin mates.
Secure the Compressor Inlet Fitting Assembly to the SPM Chassis by equally tightening
each of the four (4) 8-32 x 3 Phillips Flat Head screws.
Momentarily turn the units POWER switch to its ON position to confirm operating
power.
A DISCONNECT alarm will sound.
Turn the units POWER switch to its OFF position.
Battery Capacity
While the unit is operating on battery power, operators can best determine the relative amount
of charge in the internal battery by looking at the Battery Icon/Indicator. The Battery icon
appears in outline form and is filled with horizontal rows of lines indicating its current capacity.
Each line represents 5% of battery capacity.
Caution Only use the Power Supply provided with the unit (ZOLL PN 703-0731-01). Use of any other
power supply could cause damage or create a fire and/or destroy the battery and unit.
Caution If you witness a battery or the battery compartment starting to balloon, swell up, smoke, or feel
excessively hot, turn off the unit, disconnect external power, and observe it in a safe place for
approximately 15 minutes and send the unit for service. Never puncture or disassemble the
battery packs or cells.
Caution Never attempt to completely discharge the battery by shorting or some other method and never
ship the battery in a completely discharged state.
Caution During continuous, uninterrupted use (>100 hours), it is recommended that the ventilator be
disconnected from AC power for 30 seconds to allow the battery to run diagnostics while the
battery is discharging.
Note: The ventilator continuously monitors the available power sources; occasionally a false
Low Priority power alarm can be triggered for ~1 second. These false alarms
immediately clear themselves.
1. Battery charging is controlled by the ventilator in the temperature range of 0C to 45C
(32F to 113F) to provide the best life time for the battery.
2. The battery has a discharge (operational) temperature range of -25C to 49C (5F to 71F)
(as verified by ZOLL).
3. DO NOT store the ventilator with the batteries discharged. Always store with the battery fully
charged.
4. For long-term storage, the optimum storage temperature range is -15C to 21C (5F to
71F).
Tools needed:
Phillips Head
Screwdriver
Warning! Before attempting to replace the battery pack (ZOLL PN 703-0731-01), make sure that
external power is disconnected and the units Power Switch is set to OFF.
Procedure:
Remove the four (4) 6-32 x 5/16 Phillips Pan Head screws
located at the bottom of the unit. This will release the
Battery Pack Compartment Cover and expose the Battery
Pack and its integral mounting bracket.
Remove the four (4) 6-32 x 2 1/4 Phillips Pan Head screws that
hold the Battery Pack and its integral mounting bracket to the
units Lower Case.
The units Battery Pack is wired to a mating plug-and-socket
connector that remains electrically attached to the unit. This
mating connector includes a locking latch.
Align the plug, then insert the Battery Pack into its mating socket. The plug and socket are
keyed to protect against misconnection.
Warning! Make sure that none of the Battery Pack wires get pinched between the bracket and
case enclosure.
Align the Battery Pack Compartment Cover and secure it with the four (4) 6-32 x 5/16 Phillips
Pan Head screws.
Momentarily turn the units POWER switch to its ON position to confirm operating power.
A DISCONNECT Alarm will sound. Verify the charge status of the new Battery Pack. Turn the
units POWER switch to its OFF position. If required, place the unit on charge.
Recharging Guidelines
1. Do not store the ventilator at 100% battery charge in a high temperature environment
(~40C/104F and above) for long periods. Doing this may affect the usable life of the
battery.
2. When charging in the storage case, be advised that the battery may stop charging if ambient
temperature is above 40C/104F even though the unit is still connected to external power.
Under these conditions, battery temperature can get as high as 10C/50F above the ambient
temperature. Charging will automatically start when the ambient temperature drops.
Storage
For optimal prolonged storage periods, the unit should be stored indoors. The environment
should be clean and out of direct sunlight. Storage in non-controlled environments is
permissible if batteries are removed.
Short-term storage temperature should range between -15C to 40C (5F to 104F) and
relative humidity should be low. For long-term storage, the optimum storage temperature range
is -15C to 21C (5F to 71F). Battery life is diminished at temperatures above 35C (95F). It
is recommended that batteries be discharged to 50% capacity if long-term storage above 35C
(95F) is expected.
When batteries are in extended storage, it is recommended that they receive a refresh charge at
recommended intervals when not continuously connected to an external power source:
STORAGE AMBIENT RECHARGE INTERVAL
Below 68F (20C) 12 months
Following periods of extended storage in non-controlled environments, allow the unit sufficient
time to stabilize to a temperature within its specified operating range.
Following 6 months of continuous storage/non-use, or longer, the device should be examined,
operationally tested, and its batteries recharged before patient use is attempted. Service may be
required. Servicing should be performed by only qualified personnel.
Accuracy
Saturation (% SpO2)-During No Motion Conditions
Adults, Pediatrics 70%-100% 2 digits
0%-69% unspecified
Neonates 70%-100% 3 digits
0%-69% unspecified
Saturation (% SpO2)-During Motion Conditions
Adults, Pediatrics 70%-100% 3 digits
0%-69% unspecified
Neonates 70%-100% 3 digits
0%-69% unspecified
Pulse Rate (bpm)-During No Motion Conditions
Adults, Pediatric, Neonates 25 to 240 3 digits
Pulse Rate (bpm)-During Motion Conditions
Adults, Pediatric, Neonates 25 to 240 5 digits
Resolution
Saturation (% SpO2) 1%
Pulse Rate (bpm) 1
Low Perfusion Performance
>0.02% Pulse Amplitude Saturation (% SpO2) 2 digits
and% Transmission >5% Pulse Rate 3 digits
Interfering Substances
Carboxyhemoglobin may erroneously increase readings. The level of increase is approximately equal
to the amount of carboxyhemoglobin present. Dyes, or any substance containing dyes, that change
usual arterial pigmentation may cause erroneous readings.
IEC 60601-1
This unit meets the Classification requirements of IEC 60601-1 (3.1 edition) as indicated by the
following table:
6.2 Type of Protection against Electric Class I: Protection against electric shock does not
Shock rely on Basic Insulation only, but includes an
additional safety precaution in that means are
provided for the connection of the equipment to the
protective earth conductor in the fixed wiring of the
installation in such a way that accessible metal parts
cannot become live in the event of a failure of the
basic insulation. The medical power supply (which
contains the systems safety barrier) is labeled as
Class I or Class II. Electrical shock protection is not
dependent upon earthing since this power supply
design includes double insulation.
6.2 Degree of Protection against BF: Type B with floating (F-type) parts
Electric Shock
6.5 Degree of Safety of Application in Equipment not suitable for use in presence of
the presence of a Flammable Flammable Anesthetic Mixture of Air or with Oxygen
Anesthetic Mixture with Air or with or Nitrous Oxide
Oxygen or Nitrous Oxide
Voltage Complies
fluctuations/flicker
emissions
IEC 61000-3-3
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people.
a. The ISM (industrial, scientific, and medical) bands 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 levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz
are intended to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently
brought into patient areas. For this reason, an additional factor of 10/3 has been incorporated into the formula used in calculating the
recommended separation 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
radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the ventilator is used exceeds the applicable RF compliance level above, the ventilator should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or
relocating the ventilator.
d. Over the frequency range 150 kHz to 80 MHz, field strength should be less than 3 V/m.
The unit was tested for the effect of pressure at the patient connection port (e.g airway pressure)
on the VT and Oxygen concentration.
The tests consisted of a core matrix of volume or pressure targets for a set of resistances and
compliances, based on the ASTM F1100 guidance. These test cases were then performed at
different PEEP targets, FIO2 settings, and with different patient circuit accessories and Fresh
Gas Intake accessories. The possible settings and accessories are listed below:
Setting/Accessories Value
PEEP Settings 0, 5, 25
The following accuracies/precision were observed for adult settings with non-MRI breathing
circuit:
Parameter Accuracy/Precision
024-0012-00 AC/DC Power Supply, 100-240 VAC, 100 W, 24 V, 4.2 A, IEC 320 Plug
710-0731-01 AC/DC Power Supply and Line Cord with NEMA 5-15P termination
704-0EMV-XX Extension Cord 8 US Hospital Grade Female Plug to Country-Specific Connector (Contact
factory for complete part number for each country)
708-0041-XX Cordset, 6, IEC 60320-C5 Plug to Country-Specific Connector (Contact factory for complete
part number for each country)
820-0108-00 Heat and Moisture Exchanger/Bacterial and Viral Filter (HMEF), Adult, Deadspace 75ml
820-0108-25 Heat and Moisture Exchanger/Bacterial and Viral Filter (HMEF), Adult, Deadspace 75ml
(Case of 25)
820-0109-00 Heat and Moisture Exchanger/Bacterial and Viral Filter (HMEF), Pediatric, Deadspace 25ml
820-0109-25 Heat and Moisture Exchanger/Bacterial and Viral Filter (HMEF), Pediatric, Deadspace 25ml
(Case of 25)
820-0110-00 Heat and Moisture Exchanger/Bacterial and Viral Filter (HMEF), Inant, Deadspace 10ml
820-0110-25 Heat and Moisture Exchanger/Bacterial and Viral Filter (HMEF), Inant, Deadspace 10ml
(Case of 25)
708-0036-00 Cable, 3ft, Masimo SET Oximeter, LNCS Type DC-1, Adult Digit Sensor to DB9 Male
Note: All LNCS Masimo cables are approved for use with the ZOLL ventilators
708-0037-00 Cable, 4ft, Masimo LNCS Patient Cable Type LNC-4, DB9 Female to Male
Note: All LNCS Masimo cables are approved for use with the ZOLL ventilators
708-0039-00 Cable, 3ft, Masimo Adult Ear Sensor, LNCS Type DC-1, Adult Sensor to DB9 Male
Note: All LNCS Masimo cables are approved for use with the ZOLL ventilators
708-0047-00 Cable, 3ft, Masimo SET Oximeter, LNCS Type Inf/Inf-3, Infant Sensor to DB9 Male
708-0056-00 Cable, 3ft, Masimo SET Oximeter, LNCS Type DC-1, Adult Digit Sensor to DB9 Male, Single
Patient
Note: All LNCS Masimo cables are approved for use with the ZOLL ventilators
708-0057-00 Cable, 3ft, Masimo SET Oximeter, LNCS Type DC-1, Pediatric Digit Sensor to DB9 Male,
Single Patient
Note: All LNCS Masimo cables are approved for use with the ZOLL ventilators
708-0063-00 Extension Cord Assembly, AS 3112 (Australian) Plug to US Hospital Grade Plug
708-0064-00 Cable, 6ft, Continental Europe CEE 7/7 to IEC-60320-C5 2.5 Amp Connector
820-0130-10 MRI Circuit, Vent, Single Limb, Pediatric/Adult (disposable) (Case of 10)
820-0131-10 MRI Circuit, Vent, Single Limb, Infant/Pediatric (disposable) (Case of 10)
820-0133-00 Circuit, Vent, Single Limb, Wye, Adult/Pediatric (disposable) with Accessory Port Connector
820-0133-15 Circuit, Vent, Single Limb, Wye, Adult/Pediatric (disposable) with Accessory Port Connector
(Case of 15)
820-0134-00 MRI Circuit, Vent, Single Limb, Wye, Adult/Pediatric (disposable) with Accessory Connector
820-0134-10 MRI Circuit, Vent, Single Limb, Wye, Adult/Pediatric (disposable) with Accessory Connector
(Case of 10)
820-0124-00 Breathing Circuit support arm for Rolling Cart (ferrous, not for MRI use)
703-0731-15 Case, Transit Carry, with Wheels & Pull-Out Handle, AC Bulkhead Connector
712-0003-20 Mask, CPAP, #6, Large Adult with Harness (Case of 20)
712-0003-50 Mask, CPAP, #6, Large Adult with Harness (Case of 50)