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ZOLL Ventilator Operator’s
Guide
Models: EMV+, AEV, Eagle II
906-0731-01-01 Rev. A
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The issue date for the ZOLL Ventilator Operator’s Guide (REF 906-0731-01-01 Rev. A) is December, 2017.
0123
ZOLL Medical Corporation
269 Mill Road
Chelmsford, MA USA
01824-4105
ZOLL International Holding B.V.
Newtonweg 18
6662 PV ELST
The Netherlands
Copyright © 2017 ZOLL Medical Corporation. All rights reserved. ZOLL, AEV, EMV+, Eagle II, and
Smart Help are trademarks or registered 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
.
Limited Copyright Release
Permission is hereby granted to any military/governmental agency to reproduce all materials furnished herein
for use in a military/governmental service training program and/or other technical training program.
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Contents
Chapter 1 General Information
Product Description ............................................................................................................ 1-1
How to Use this Manual...................................................................................................... 1-1
Operator’s Guide Updates .................................................................................................. 1-2
Unpacking...........................................................................................................................1-2
Assembly ............................................................................................................................ 1-2
Symbols on the Ventilator ................................................................................................... 1-2
Symbols on the Ventilator’s Graphical User Interface (GUI)............................................... 1-5
Conventions........................................................................................................................ 1-7
Abbreviations ...................................................................................................................... 1-8
ZOLL Ventilator Indications for Use .................................................................................... 1-9
Ventilation ...................................................................................................................1-9
Pulse Oximetry (SpO2) ............................................................................................... 1-9
Features .................................................................................................................... 1-10
Warnings........................................................................................................................... 1-11
General .....................................................................................................................1-11
Ventilator ................................................................................................................... 1-11
Pulse Oximeter ......................................................................................................... 1-12
Batteries .................................................................................................................... 1-13
Operator Safety ........................................................................................................ 1-13
Patient Safety ........................................................................................................... 1-14
Ferromagnetic Equipment ........................................................................................ 1-14
Cautions ....................................................................................................................1-15
FDA Tracking Requirements............................................................................................. 1-16
Notification of Adverse Events .................................................................................. 1-16
Software License ..............................................................................................................1-17
NO IMPLIED LICENSE ...................................................................................... 1-17
Limited Warranty ....................................................................................................... 1-18
Service..............................................................................................................................1-19
Returning a Device for Service .......................................................................... 1-19
Chapter 2 Product Overview
ZOLL Ventilator Models ......................................................................................................2-2
ZOLL Ventilator Features.................................................................................................... 2-3
ZOLL Ventilator Device Description.................................................................................... 2-4
Controls and Indicators....................................................................................................... 2-6
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Display Screen.................................................................................................................... 2-7
Message Area ............................................................................................................. 2-7
Parameter Windows ................................................................................................... 2-7
Shared Icon Area ........................................................................................................ 2-8
Auxiliary Parameter Boxes ......................................................................................... 2-8
Pneumatic Design............................................................................................................... 2-9
Fresh Gas Intake and Attachments .................................................................................. 2-10
Top Panel.......................................................................................................................... 2-10
Oxygen Input: High Pressure Gas Supply ................................................................ 2-11
High Pressure Oxygen Supply Hose ................................................................. 2-11
Ventilator Circuits.............................................................................................................. 2-12
Ventilator Circuit Types ............................................................................................. 2-14
Heat and Moisture Exchangers (HMEs) ............................................................ 2-15
Pulse Oximeter Sensors ................................................................................................... 2-15
Power Sources ................................................................................................................. 2-15
Operating Using External DC Power ........................................................................ 2-16
Operating Using Battery Power ................................................................................ 2-16
Chapter 3 Setting Up the ZOLL
Ventilator
1. Attach the Ventilator Circuit............................................................................................. 3-2
2. Attach the High Pressure Oxygen Supply (Optional)...................................................... 3-3
3. Inspect Fresh Gas Intake Filters..................................................................................... 3-3
4. Connect Fresh Gas Intake Attachments ......................................................................... 3-4
Oxygen Reservoir Bag ......................................................................................... 3-4
Bacterial/Viral (BV) Filter ..................................................................................... 3-4
Chemical/Biological C2A1 Filter .......................................................................... 3-4
5. Select the Ventilator’s Power Source.............................................................................. 3-5
Connecting the Power Supply .................................................................................... 3-6
6. Power On the Ventilator.................................................................................................. 3-7
7. Select Start Up Default Values ........................................................................................ 3-8
Adult Default Parameter Values .......................................................................... 3-8
Pediatric Default Parameter Values ..................................................................... 3-8
Mask CPAP Default Parameter Values ............................................................... 3-9
8. Select Operating Mode (Optional) ................................................................................ 3-10
9. Change Parameter Values............................................................................................ 3-11
10. Change Device Settings ............................................................................................. 3-11
Alarm Configuration .................................................................................................. 3-11
Powerup Settings ...................................................................................................... 3-12
Specifying Powerup Settings ............................................................................. 3-12
Specifying Custom Settings ............................................................................... 3-12
Specifying a Language ...................................................................................... 3-13
LCD Contrast ............................................................................................................3-13
LCD Brightness ......................................................................................................... 3-13
UTC Offset ................................................................................................................ 3-14
Unit Info .................................................................................................................... 3-14
Alarm History ............................................................................................................ 3-15
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11. Perform Operational Test ............................................................................................ 3-16
12. Attach the Pulse Oximeter Probe (Optional)............................................................... 3-17
13. Attach Patient..............................................................................................................3-18
Chapter 4 Using the ZOLL Ventilator
The Ventilator Interface....................................................................................................... 4-2
Changing Parameter Values ....................................................................................... 4-2
Parameter Buttons.............................................................................................................. 4-2
Mode...................................................................................................................................4-2
Breath Target .............................................................................................................. 4-3
Leak Compensation .................................................................................................... 4-3
BPM (Breathes Per Minute) -- Timing and Rate Management ........................................... 4-5
Control Parameter ...................................................................................................... 4-5
Rise Time .................................................................................................................... 4-5
Cycle Off % Parameter ........................................................................................ 4-6
Spont Ti Limit Parameter ..................................................................................... 4-6
Manual Breath/Plateau Pressure Button ............................................................. 4-6
BPM Parameter Settings ............................................................................................ 4-7
Vt (Tidal Volume) ................................................................................................................ 4-8
PIP (Peak Inspiratory Pressure) -- Pressure Management ................................................ 4-9
Spontaneous/Assisted Breath Trigger ...................................................................... 4-10
Plateau Pressure ...................................................................................................... 4-10
Pressure Management ............................................................................................. 4-11
FIO2 (Fraction of Inspired Oxygen) -- Oxygen Delivery Management.............................. 4-12
SpO2 -- Using the Pulse Oximeter.................................................................................... 4-13
SpO2 Parameter Values ........................................................................................... 4-14
HR (Heart Rate)................................................................................................................ 4-16
Managing Pop Up Messages............................................................................................ 4-17
Managing Alarms.............................................................................................................. 4-18
Smart Help Messages .............................................................................................. 4-19
Alarm Priorities ......................................................................................................... 4-20
Silencing Alarms ............................................................................................................... 4-21
Alarm Preemptive Mute upon Power up ............................................................ 4-21
Turning Off Alarms at Extreme Range Limits ........................................................... 4-22
Alarm Cancellation in Alarm Configuration Menu ..................................................... 4-23
Chapter 5 Alarms
Alarm Overview ..................................................................................................................5-1
Alarm Priorities ................................................................................................................... 5-3
High Priority ......................................................................................................... 5-3
Medium Priority .................................................................................................... 5-3
Low Priority (Advisory) ......................................................................................... 5-3
Pop Up Messages ............................................................................................... 5-3
Muting Alarms..................................................................................................................... 5-4
Alarms Types ......................................................................................................................5-4
Alarm Groups...................................................................................................................... 5-5
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High Priority Alarms ............................................................................................................5-6
Medium Priority Alarms..................................................................................................... 5-11
Low Priority Alarms........................................................................................................... 5-21
Pop Up Messages ............................................................................................................ 5-31
Chapter 6 Operating Environments
Using the ZOLL Ventilator in Harsh Environments ............................................................. 6-1
Airborne Particulates .................................................................................................. 6-1
Extreme Temperature Environments .......................................................................... 6-2
Operating at High Temperatures ......................................................................... 6-2
Operating at Low Temperatures .......................................................................... 6-2
Altitude ........................................................................................................................ 6-3
Rain and Snow ........................................................................................................... 6-4
Using the ZOLL Ventilator in Hazardous Environments...................................................... 6-4
Bacterial/Viral Filter Use ...................................................................................... 6-5
Chemical/Biological Filter Use ............................................................................. 6-5
Check Valve on Breathing Circuit when in Hazardous Environments ................. 6-5
Using the ZOLL Ventilator in an MRI Environment ............................................................. 6-7
Chapter 7 Maintenance
Inspecting the ZOLL Ventilator ........................................................................................... 7-1
Cleaning.............................................................................................................................. 7-2
Post-Contaminated Environment Cleaning ................................................................. 7-3
Gas Intake Filters................................................................................................................ 7-3
Inspecting and Replacing the Foam Filter .................................................................. 7-3
Inspecting and Replacing the Disk Filter .................................................................... 7-3
Replacing the ZOLL Ventilator’s Filters ..............................................................................7-4
Replacing the Foam Filter ........................................................................................... 7-4
Replacing the Disk Filter ............................................................................................. 7-5
Battery Maintenance........................................................................................................... 7-5
Battery Storage ........................................................................................................... 7-7
Ventilator Storage ....................................................................................................... 7-8
Battery Replacement and Shipping Regulations ........................................................ 7-8
Calibration Checks..............................................................................................................7-8
Electrical Safety Check....................................................................................................... 7-8
Troubleshooting .................................................................................................................. 7-9
Appendix A Specifications
General ...............................................................................................................................A-1
Pulse Oximeter ...................................................................................................................A-3
Device Classification...........................................................................................................A-4
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Appendix B Accessories
Appendix C Pulse Oximeter Principles
Appendix D Patient Circuits
Pediatric/Adult, Infant/Pediatric, Single-Limb, Wye Patient Circuits ...................................D-2
Intended Use -- Pediatric/Adult Patient Circuits ..........................................................D-2
Specifications ..............................................................................................................D-2
General ................................................................................................................D-2
Pediatric/Adult, 6 ft Patient Circuit .......................................................................D-3
Infant/Pediatric, 6 ft Patient Circuit ......................................................................D-3
Pediatric/Adult, 12 ft Patient Circuit .....................................................................D-3
Infant/Pediatric, 12 ft Patient Circuit ....................................................................D-3
Directions for Use .......................................................................................................D-4
Troubleshooting Patient Circuits .................................................................................D-5
Troubleshooting -- Infant/Pediatric Patient Circuits .............................................D-6
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Page 9
This chapter provides general information about the ZOLL ventilator and the ZOLL Ventilator
Operator’s Guide, which we provide with this product. Specifically, this chapter provides
• A brief description of the ZOLL Ventilator.
• Information about this manual (ZOLL Ventilator Operator’s Guide).
• A table that describes the symbols that appear on the ventilator and in this manual.
• The ZOLL Ventilator’s Indications for Use.
• A list of Warnings and Cautions regarding the use of the ventilator.
• Information regarding FDA tracking requirements, and the product’s warranty and software
license.
• How to contact ZOLL Medical Corporation for service to this product.
Product Description
The ZOLL Ventilator is a small, extremely durable, full-featured portable mechanical ventilator
designed to operate in hospitals or severe and under-resourced environments. It can be used in
prehospital, field hospital and hospital settings.
Chapter 1
General Information
How to Use this Manual
The ZOLL Ventilator Operator’s Guide provides information that operators need for the safe
and effective use and care of the ventilator. It is important that all persons using this device read
and understand all the information contained within.
Please throughly read the warnings section.
Procedures for device care are located in Chapter 7, “Maintenance”.
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General Information
Operator’s Guide Updates
An issue or revision date for this manual is shown on the front cover. If more than 3 years have
elapsed since this date, contact ZOLL Medical Corporation to determine if additional product
information updates are available.
All users should carefully review each manual update to understand its significance and then
file it in its appropriate section within this manual for subsequent reference.
Product documentation is available through the ZOLL website at www.zoll.com. From the
Products menu, choose Product Manuals.
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 Self Check, U.S.A. customers should
call ZOLL Medical Corporation (1-978-421-9655). 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 device only requires that you 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.
Symbols on the Ventilator
The following symbols appear on the ventilator or in this manual:
Symbol Description
Off
On
Direct Current: Identifies the location to connect external DC Power.
Mute / Cancel: Identifies button which mutes the active alarms or cancels
the parameter selection.
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Symbol Description
Accept / Confirm: Identifies button which accepts the parameter
selection.
ESD: Warns that connector pins should not be touched.
Identifies the dial that allows the selection of parameter values.
Do Not Re-Use: This item should not be re-use
Do Not Discard: Follow all governing regulations regarding the disposal
of any part of this medical device.
Serial Number: Numbers following “SN” indicate the serial number.
Defibrillation Proof: Indicates the degree of protection against electrical
shock.
BF Symbol: Protection against electric shock, Type B with floating
(F-type) parts.
MR Symbol: Identifies the use of the device’s ability to perform in a MRI
environment.
d.
Power Input Orientation: Locates the DC input identifying its point of
insertion.
Manufacturer: This symbol shall be adjacent to the name and address of
the manufacturer.
Manufacturer Date: Manufacturer Date Symbol identifies the device’s
date of manufacture.
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General Information
280 - 600 kPa
(40 - 87 PSIG)
O
2
NOT OCC
Symbol Description
Consult Instruction: Consult the instructions for use or operation manual.
Refer to instruction manual.
Menu icon. This icon identifies the button that, when pressed, displays a
menu of options that you can select to configure the ventilator.
High Pressure O
Connector (top faceplate icon).
2
Exhalation Valve (top faceplate icon).
Exhaust Do Not Occlude (top faceplate icon).
Transducer (top faceplate icon).
Gas Output -- Patient Circuit Connector (top faceplate icon).
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Symbols on the Ventilator’s Graphical User Interface (GUI)
+
LC
LC
_ _ _
_ _
The following symbols appear on the ventilator’s Graphical User Interface (GUI):
Symbol Description
Heart: Provides indication that the pulse oximeter is in use.
Alarm Bell: Identifies the number of off-screen alarms
Alarm Bell Outline: Identifies alarm limit settings; Identifies the on-screen
alarms.
O2 reservoir mode is in use.
Leak Compensation (LC) feature is ON.
Leak Compensation Feature is OFF.
Patient Detect Mode: Backup Ventilation Started.
Not receiving a reading.
Attention: High Priority Alarm Active.
Caution: Medium Priority Alarm Active.
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General Information
EXT
BATT
off
on
Symbol Description
Warning: Low Priority Alarm Active.
Mute: Active Alarm Audible Signal Muted.
Speaker: Active Alarm Audible Signal
Oxygen Supply: Oxygen Supply Connected.
External Power: Indicates the device is operating using an external
power source.
No External Power: Indicates the device is operating without an external
power source.
Internal Battery: Provides indication of battery capacity and charging.
Indicates that an external battery is powering the ventilator.
No Internal Battery: Indicates when internal battery is not an available
power source.
Head with Mask: the device is in Non-invasive Positive Pressure
Ventilation (NPPV) mode.
Feature OFF -- feature or alarm not selected.
Feature ON -- feature or alarm has been selected.
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Symbol Description
srch
stby
Conventions
This guide uses the following conventions:
Search
Contains PhthalatesStandby.
Contains Phthalates
Non-Sterile
Within text, the names and labels for physical buttons and soft-keys appear in boldface type
(for example, “Press the Confirm button”).
This guide uses uppercase italics for text messages displayed on the screen.
(for example, EXTERNAL POWER FAILURE).
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 device.
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General Information
Abbreviations
A/C- Assist/Control I:E- Inverse ratio
AEV- Automatic Electrical Ventilator ID - Internal Diameter
ACLS- Advanced Cardiac Life Support L - Liters
ALS- Advanced Life Support LCD- Liquid Crystal Display
ATL S- Advanced Trauma Life Support LED - Light Emitting Diode
ACV- Assist-Control Ventilation LPM - Liters Per Minute
AMC- Alarm Message Center ml - Milliliters
APOD- Advanced Probe Off Detection mm - Millimeter
ATP D - Atmospheric Temperature and Pressure Dry MRI- Magnetic Resonance Imaging
b/min- Beats Per Minute NPPV – Noninvasive Positive Pressure Ventilation
B/V - Bacterial/Viral Filter O
BiPAP- Bilevel positive airway pressure P
BPM - Breaths per Minute PEEP - Positive End Expiratory Pressure
cm H
O - Centimeters of Water PIP - Peak Inspiratory Pressure
2
CPAP- Continuous Positive Airway Pressure PPV- Positive-Pressure Ventilation
CPR - Cardiopulmonary Resuscitation PS- Pressure support
CPU- Central Processor Unit psig - Pounds per Square Inch Gage
dBA- Decibel RF- Radio Frequency
DISS - Diameter Index Safety System RGA #- Returned-Goods-Authorization number
EMC- Electromagnetic Compatibility RTC- Real time clock
EMV- Emergency Medical Ventilator SIMV- Synchronized Intermittent Mandatory
ESD- Electrostatic Discharge SPM- Smart Pneumatic Module
FIO
Fraction of Inspired Oxygen USP - United States Pharmacopeia
2 -
HME - Heat and Moisture Exchanger VAC - Volts AC
HMEF - Heat and Moisture Exchanger/Bacterial Viral
filter combined
- oxygen
2
- Airway Pressure
aw
Ventilation
VDC - Volts DC
HP O
- High Pressure Oxygen VT - Tidal Volume
2
Hz – Hertz (as in frequency, cycles per second) WOB – Work Of Breathing
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ZOLL Ventilator Indications for Use
Ventilation
Each model of the ZOLL 731 Series of Ventilators is indicated for use in the management of
infant through adult patients weighing greater than or equal to 5 kg with acute or chronic
respiratory failure or during resuscitation by providing continuous positive-pressure
ventilation. ZOLL Ventilators are appropriate for use in hospitals, outside the hospital, during
transport and in severe environments where they may be exposed to rain, dust, rough handling,
and extremes in temperature and humidity. With an appropriate third-party filter in place, they
may be operated in environments where chemical and/or biological toxins are present. When
marked with an "MRI conditional" label, ZOLL Ventilators are suitable for use in an MRI
environment with appropriate precautions. ZOLL Ventilators are intended for use by skilled
care providers with knowledge of mechanical ventilation, emergency medical services (EMS)
personnel with a basic knowledge of mechanical ventilation, and by first responders under the
direction of skilled medical care providers.
Pulse Oximetry (SpO2)
The ZOLL Ventilator pulse oximeter with Masimo Rainbow® SET technology is intended for
use for continuous noninvasive monitoring of functional oxygen saturation of arterial
hemoglobin (SpO
use on adult and pediatric patients during both no motion and motion conditions, and for
patients who are well or poorly perfused, in hospitals, hospital-type facilities, or in mobile
environments.
), and pulse rate. The pulse SpO2 oximeter and accessories are indicated for
2
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General Information
Features
• Portable ventilator that you can use in the hospital, aeromedical and ground transport, mass
• Multiple modes of ventilation for use with acute or chronic respiratory failure in both
• Intuitive operator interface minimizes operator training and protects existing settings from
• Lightweight -- less than 10 lbs (4.4 kg) -- for easy transport.
• Rechargeable battery provides over 10 hours of operation (at factory default with pulse
• Operating temperature range for extreme conditions: -26 to 55C (-15 to 131F).
• Altitude compensation from -2,250 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
• Sealed gas path with chemical/biological filter connected to assure safe breathing gas
• Sealed case and control panel protects components from weather and fluids.
• Smart Help messages guide the operator through on-screen commands when responding to
casualty situations, and extreme environments.
intubated and non-intubated patients.
inadvertent contact and manipulation.
oximeter operating).
oxygen is delivered to the patient breathing circuit.
supply.
alarms.
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Warnings
General
Ventilator
• The ZOLL Ventilator is intended for use by qualified personnel only. You should read this
manual before using the device.
• Before using the ventilator on a patient, you must test the device in its normal configuration
to ensure proper operation.
• Do not modify this equipment without authorization of the manufacturer.
• This operator’s guide is not meant to supersede any controlling operating procedure
regarding the safe use of assisted ventilation.
• Follow all governing regulations regarding the disposal of any part of this medical device,
the handling of materials contaminated by body fluids, and shipment of the Li-ION
batteries.
• The ZOLL Ventilator can operate from its internal battery or from an external power source.
When using an external power source, position the supply cables to avoid accidental
disconnect.
• The use of accessories and cables other than those sold by ZOLL may result in increased
emissions or decreased immunity of this device.
• Portable and mobile RF communication equipment may affect the performance of this
device. We describe the EMC performance for this device in the Specifications section of
this operator’s guide.
• The ventilator 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.
• Do not connect to an electrical outlet controlled by a wall switch or dimmer.
• The protection against defibrillator depends on the use of accessories (including Pulse
Oximeter) that are specified by ZOLL.
• Grounding:
• 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 taximeter on internal battery power until the AC power
supply protective cover is fully functional.
• As with all medical equipment, carefully route the ventilator circuit, patient cabling, and
external power cables to reduce the possibility of patient entanglement or strangulation.
The product design includes materials with phthalates in the pressure lines of
both the manifold design and patient circuit. Patient mask accessories used
with the device also are made with materials containing phthalates.
Phthalates are NOT present in the inspiratory line (Gas Hose) of the patient
circuit.
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General Information
• Do not use the device during magnetic resonance imaging (MRI) scanning unless it has the
appropriate “MRI conditional” label. See “Using the ZOLL Ventilator in an MRI
Environment” for instructions on the use of MRI conditional units, which gives additional
Warnings and Cautions.
• Do not operate the ZOLL Ventilator on a patient when the USB port is connected to any
other device (you use the USB port only for servicing the ventilator).
• The ZOLL-supplied ventilator circuit’s labeling provides the resistance and compliance
values for the circuits under normal operating conditions. If added accessories are used
(e.g. HME, filters etc.), you should assure they do not degrade the performance of the
device.
Pulse Oximeter
• Do not use the pulse oximeter 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 patient’s condition.
• Measurements: if the accuracy of any measurement does not seem reasonable, first check
the patient’s vital signs by alternate means and then check the pulse oximeter for proper
functioning.
Inaccurate measurements may be caused by:
• 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.
• 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.
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• Loss of pulse signal can occur in any of the following situations:
• The sensor is too tight.
• Excessive illumination from light sources such as a surgical lamp, a Rubin lamp, or
sunlight.
• A blood pressure cuff is inflated on the same extremity as the one with an SpO
2
sensor attached.
• The patient has hypotension, severe vascoconstriction, severe anemia, or
hypothermia.
• Arterial occlusion proximal to the sensor.
• The patient is in cardiac arrest or is in shock.
• Sensors:
• Before use, carefully read the LNCS
• Use only Masimo oximetry sensors for SpO
®
sensor directions for use.
measurements. Other oxygen
2
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
• Do not use damaged patient cables. Do not immerse the patient cables in water,
sensors.
solvents, or cleaning solutions (the patient cables are not waterproof). Do not
sterilize by irradiation, steam, or ethylene oxide. See the cleaning instructions in
the directions for reusable Masimo patient cables.
• Do not use the pulse oximeter sensor during magnetic resonance imaging (MRI) scanning.
Inducing current could potentially cause burns. The pulse oximeter may affect the MRI
image and the MRI unit may affect the accuracy of the dosimetry measurements.
Batteries
• Only use the Power Supply provided with the device. Use of any other power supply could
cause damage or create a fire and/or destroy the battery and device.
• If you witness a battery or the battery compartment starting to balloon, swell up, smoke, or
feel excessively hot, turn off the device, disconnect external power, and observe it in a safe
place for approximately 15 minutes and send the device for service. Never puncture or
disassemble the battery packs or cells.
Operator Safety
• Electric shock hazard: Do not remove equipment covers. You may only perform
maintenance procedures specifically described in this manual. Refer all servicing to
ZOLL or a ZOLL-authorized service center.
• 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.
• This device is not intended for use in explosive atmospheres.
• Pins of connectors identified with the ESD warning symbol should not be touched. Always
use precautionary procedures with ESD-sensitive connections.
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General Information
Patient Safety
• To ensure patient electrical isolation, connect only to other equipment with electronically
isolated circuits.
• Do not place the device or external power supply in any position that might cause it to fall
on the patient. Do not lift the device by the power supply cord, ventilator circuit, or pulse
taximeter patient cable.
• Never service the ventilator while in use with a patient.
Ferromagnetic Equipment
• Failure to follow all instructions can result in MRI artifacts, injury to the patient or
operator, or malfunction of the device.
• You must follow all safety procedures that are in effect for the MRI Environment. Do
not use the ventilator in an MRI Environment with greater than 3T magnetic force.
• You must secure the device to a suitable MRI-compatible cart -- ZOLL MRI Roll
Stand (REF 816-0731-01); Optional IV Arm Assembly (REF 707-0731-09).
• You must place the ventilator behind the 2000 Gauss field line -- approximately 2
meters to the bore opening of the MRI magnet.
• The ventilator must be attended by a person with no other responsibility than
monitoring the device and patient while in the MRI Environment.
• You must visually monitor the ventilator for alarms at all times -- during imaging,
the alarms may not be audible beyond the area immediately adjacent to the MRI.
• Danger! Possible Missile Projection.
• DO NOT position any person between the bore entrance and an unsecured cart or
device.
• Lock the wheels when the rolling stand is in place.
• We recommend that you tether the rolling stand in place when in the MRI
Environment.
• Place the ventilator and stand in its position before the patient is positioned on the
scanner table and advanced into the bore.
• Remove the patient from the MRI Environment before removing the ventilator and
roll stand.
• Unapproved device apparatus shall NOT be allowed in the MRI Environment,
including:
• Pulse Oximeters sensors and cabling.
• External AC/DC Power Supply.
• Rolling Cart Breathing Circuit Arm.
• Active Humidification and associated support apparatus.
• Ensure proper configuration of the ventilator.
• DO NOT attach the pulse oximeter sensor to the patient and remove it from the
device.
• The ventilator should run only on battery power in the MRI Environment
-- DO NOT use an external AC/DC power supply.
• The ventilator’s battery should be fully charged before entering the MRI
Environment.
• Oxygen Supply -- an aluminum, non-magnetic cylinder must provide the oxygen
supply.
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Cautions
• Ensure proper operation of the ventilator’s breathing system.
• 12 ft ventilator circuits are available for use with the ventilator -- the additional
length enables a suitable separation between the ventilator and the bore opening.
(REF 820-130-00 -- Adult/Pediatric Wye Ventilator Circuit; REF 820-131-00 -Pediatric/Infant Wye Ventilator Circuit).
• The extended tubing length of a 12 ft ventilator circuit can result in loss of volume
due to additional compressibility.
-- Set the Tubing Compliance (TC) to OFF and ensure that the patient is
receiving correct tidal volume.
-- Alternatively, calculate the TC as described by the ventilator circuit’s
Instructions For Use (IFU) and adjust the TC value to ensure that the patient is
receiving the correct tidal volume.
• DO NOT use the 12 ft circuit with settings below 5 cmH20.
• Ensure that the ventilator is able to maintain PEEP -- for patients with short
expiratory times, the additional tubing length of the 12 ft circuit may affect system
behavior.
• Inspect the circuit every day to ensure that there is no damage or wear that could affect its
performance. Remove Fluid or other biological material from the circuit or replace the
circuit following the local standard of care.
• Federal law restricts this device to sale by or on the order of a physician.
• Only qualified biomedical equipment technicians should service the device.
• 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, cables, or patient circuits.
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General Information
FDA Tracking Requirements
U.S. Federal Law (21 CFR 821) requires the tracking of ventilators. Under this law, owners
of this ventilator must notify ZOLL Medical Corporation if this product is
• received
• lost, stolen, or destroyed
• donated, resold, or otherwise distributed to a different organization
If any such event occurs, contact ZOLL Medical Corporation in writing with the following
information:
1. Originator's organization – Company name, address, contact name, and contact phone
number
2. Model number, and serial number of the ventilator
3. Disposition of the ventilator (for example, received, lost, stolen, destroyed, distributed to
another organization), new location and/or organization (if known and different from
originator’s organization) – company name, address, contact name, and contact phone
number
4. Date when the change took effect
Please address the information to:
ZOLL Medical Corporation
Attn: Tracking Coordinator
269 Mill Road
Chelmsford, MA 01824-04105
Fax: (978) 421-0007
Telephone: (978) 421-9655
Notification of Adverse Events
As a health care provider, you may have responsibilities under the Safe Medical Devices Act
(SMDA), for reporting to ZOLL Medical Corporation, and possibly to the FDA, the occurrence
of certain events.
These events, described in 21 CFR Part 803, include device-related death and serious injury or
illness. In addition, as part of our Quality Assurance Program, ZOLL Medical Corporation
requests to be notified of device failures or malfunctions. This information is required to ensure
that ZOLL Medical Corporation provides only the highest quality products.
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Software License
Note: Read this Operator’s Guide and License agreement carefully before operating any of
the 731 Series 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.
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General Information
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.
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Service
If a device requires service, contact the ZOLL Technical Service Department.
For customers In the U.S.A. For customers outside the U.S.A.
Telephone:
Fax:
1-973-882-1212
1-978-421-0010
Call the nearest authorized ZOLL Medical Corporation
representative.
To locate an authorized service center, contact the
International Sales Department at
ZOLL Medical Corporation
269 Mill Road
Chelmsford, MA 01824
Telephone: 1-978-421-9655
When requesting service, please provide the following information to the service
representative:
• Device 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 device with an expired warranty
Returning a Device for Service
Before sending a device to the ZOLL Technical Service Department for repair, obtain a service
request (SR) number from the service representative.
The Li-ion battery should remain inside the device. Follow directions provided on the return
authorization form. Pack the device with its cables in the original containers (if available) or
equivalent packaging. Be sure the assigned service request number appears on each package
and follow the Shipping Regulations as described in Chapter 7 of this manual..
For customers Return the device to
In the U.S.A. ZOLL Medical Corporation
269 Mill Road
Chelmsford, MA 01824
Attention: Technical Service Department (SR number)
Telephone: 1-978-421-9655
In Canada ZOLL Medical Canada Inc.
1750 Sismet Road, Unit #1
Mississauga, ON L4W 1R6
Attention: Technical Service Department (SR number)
Telephone: 1-866-442-1011
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General Information
For customers Return the device to
In other locations The nearest authorized ZOLL Medical Corporation
representative.
To locate an authorized service center, contact the
International Sales Department at
ZOLL Medical Corporation
269 Mill Road
Chelmsford, MA 01824-4105
Telephone: 1-978-421-9655
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Chapter 2
Product Overview
This chapter provides an overview of the ZOLL Ventilator, which you can use to manage infant
through adult patients with acute or chronic respiratory failure or patients that you are
resuscitating by providing continuous positive-pressure ventilation. (See Indications for Use
in Chapter 1.)
This chapter describes the ZOLL Ventilator models, providing a list of common features and
attributes, as well as descriptions of each model. This chapter also provides more detailed
descriptions of the following ventilator features:
• Controls and Indicators
• Display Screen
• Pneumatic Design
• Fresh Gas Intake
• Connector Panel
• Ventilator Circuits
• Pulse Oximeter
• Power Sources
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Product Overview
ZOLL Ventilator Models
The ZOLL Ventilator is available as the AEV, EMV+, and Eagle II models. The ventilator
offers a range of ventilatory modes to support EMS, military, air transport, and hospital
transport needs.
The AEV ventilator is designed for managing ventilator support patients during ambulance
transport. Its ventilation modes (AC, CPAP with PS, and BL) are specifically chosen to be
consistent with pre-hospital care provider's operating procedures.
The EMV+ ventilator's 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, CPAP, and
BL.
The Eagle II ventilator adapts the design of for the EMV+ for use by emergency departments
and intra-hospital transport. Its design also allows it to be mounted onto walls or onto specified
boom arms and roll stands as well as gurneys.
The ZOLL MRI ventilators have been approved for use in MRI suites. The EMV+ and Eagle II
ventilators have MRI-compatible variants available. The MRI-compatible ventilators can
operate in 3.0 Tesla environments and can be placed approximately 6 1/2 ft. from the bore
opening for easy and safe access to the patient. See Chapter 3 for more information regarding
safe operation in the MRI Environment.
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ZOLL Ventilator Features
The ZOLL Ventilator models have these common features:
• Rugged design
• Weight: ~10 lbs
• 10 hour battery life
• Rapid charger to achieve 90% battery capacity in 2 hours
• High performance internal compressor
• Smart Help messages
• Integral SpO
• Airworthiness Release
• Daylight visible display
• Oxygen efficient
• Supports infant, pediatric, and adult patients
• Limited 1 year warranty
(Masimo)
2
Product Overview
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Product Overview
1
2
345
10
6
7
8
9
11
ZOLL Ventilator Device Description
The following illustration shows the ZOLL Ventilator’s main features:
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Product Overview
Item Description
Top
1. Oxygen Inlet Connects the device to an external oxygen source
2. Status Indicator LED Array Lights up to indicate status of the device, connected to alarms
3. External Power Input Connector Connects the device to an external power source
4. USB Connector Connects the device to a USB drive or USB compatible device
5. Pulse Oximeter Connector Connects the device to a Pulse Oximeter sensor
Front
6. LCD Display Displays the device’s settings, patient data, and alarm information
7. Alarm Message Center Displays active alarms and mitigation information
8. Control Panel Access to the device settings
Bottom
9. Battery Compartment Contains the device’s rechargeable Li-ion battery
Side
10. Fresh Gas/Emergency Air Intake Allows the device’s internal compressor to take ambient air and acts as
an
anti-asphyxia valve
11. Handle
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Product Overview
1
6
2
4
7
5
3
8
9
Controls and Indicators
The ZOLL Ventilator has controls and indicators that facilitate ease of use and visibility in all
operating environments.
This ventilator’s control panel includes a display screen (liquid crystal display -- LCD), an LED
array, and the controls that you use to set up and manage the ventilator.
The ventilator’s controls consist of the following:
1. Power On/Off Switch -- turns the ventilator on and off.
2. Parameter buttons -- chooses parameter values.
3. Menu Button -- displays the main menu.
4. Selection dial -- changes the value of the highlighted parameter value.
5. Mute/Cancel button -- mutes audible alarm indicators and cancels parameter entries.
6. Accept/Select button -- accepts parameter value entries, Pop Up conditions or menu
selections.
7. Manual Breath/P Plat (Plateau Pressure) button -- issues a manual breath, and for the
EMV+ and Eagle II models, provides the ability to conduct a plateau pressure maneuver.
The ventilator’s indicators consist of the following:
8. LCD Display -- Brightness and backlight controls are available in the main menu (we
describe the display in more detail later in this chapter).
9. LED Array -- Indicates status of the ventilator’s operation by lighting red, yellow, or green
LED’s.
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Display Screen
Message Area
Shared Icon Area
Auxiliary Parameter Boxes
Parameter Windows
The ZOLL Ventilator’s display screen has four functional areas:
Product Overview
Message Area
The display screen’s message area can display the following:
• Airway Pressure and Pleth Waveform Plots -- Under normal operation (as in the example
• Menus -- Displays the Main Menu after you press the menu button on the ventilator’s
• Alarms -- When an alarms occur, the message area displays Smart Help messages that
• Popup Windows -- Display information that assists you when adjusting parameter values.
Parameter Windows
Parameter windows display the measurements, alarm limits, and associated parameters for their
labeled parameters. Parameter values that you can adjust, such as alarm limits, appear as solid
text. Parameter values that you cannot adjust, such as measurements taken by the ventilator,
appear as outlined text. We provide information on adjusting parameter values in Chapter 4,
“Using the ZOLL Ventilator.”
above), the message area displays plots for airway pressure and, when the pulse oximeter is
connected, the Pleth waveform.
control panel, or displays a parameter’s context menu (which appears after you press and
hold the associated parameter button on the control panel). When a plot is necessary to
facilitate a parameter adjustment, the message area displays both the plot and the
parameter’s context menu.
identify the alarms and describe possible causes and actions that you can take in response.
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Product Overview
Shared Icon Area
Directly below the message area, the device displays icons that indicate
• Power source (external power or internal battery)
• Battery Charge Status
• Oxygen Supply attached
• Alarm Muted/Audible
Auxiliary Parameter Boxes
Some parameters have values that the ventilator displays in the parameter boxes at the bottom
of the display screen. You can adjust these values using the parameter’s context menu.
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Pneumatic Design
The ZOLL Ventilator includes an oxygen valve and a compressor to provide the gas to the
output port. The system includes transducers for pressure measurements including input supply
pressure and barometric readings.
The wye circuit is part of the ventilator’s pneumatic system. The inspiratory side of the wye
circuit provides gas to the patient. The expiratory side exhausts directly to atmosphere without
returning to the ventilator. The ventilator pneumatically controls the exhalation valve and a
transducer within the ventilator measures the airway pressure.
The following image is a diagram of the ventilator’s pneumatic design.
Product Overview
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Product Overview
External Power Input
Gas Output
High Pressure
Oxygen Input
Transducer
(Patient Airway
Pressure)
Exhalation
Valve
Fresh Gas/
Emergency
Air Intake
Pulse Oximeter Connector
+ USB Connector
Fresh Gas Intake and Attachments
The fresh gas intake, which is located on the side of the ventilator, allows ambient air into the
device’s internal compressor. The intake also acts as an anti-asphyxia value that enables the
patient to breath ambient air should the ventilator fail.
The fresh gas intake contains a particulate filter and permits the operator to connect either a
bacteria/viral or a chemical/biological filter depending on ambient conditions
ZOLL provides an O
oxygen concentrator source provides oxygen to the O
Top Panel
The ZOLL Ventilator’s top panel appears as follows:
Reservoir Kit to allow for low flow oxygen supply to the ventilator. An
2
reservoir.
2
The oxygen hose, ventilator circuit, external power, and pulse oximeter attach to the top panel
of the ventilator. The USB port is only used when servicing the device.
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Oxygen Input: High Pressure Gas Supply
The external high pressure gas source connects to the device using the high pressure oxygen
input port.
The device attaches to a regulated supply of 40 to 87 PSIG (280 to 600 kPa). The maximum
flow rate of the oxygen supply is 100 liters per minute. This supply can be from a medical
grade oxygen system or oxygen cylinder (USP).
The OXYGEN IN fitting has a male oxygen Diameter Index Safety System (D.I.S.S.) thread.
Note: If external oxygen is connected, the gas pressure must be at least 41-psig (± 2 psig) when
the device performs Self-Check after you power on the device.
High Pressure Oxygen Supply Hose
A standard 6 foot oxygen hose is available to make the connection to the high pressure oxygen
source. The hose is has compatible fittings between the device an the source identified for use.
(Also see Chapter 6 “Operating Environments”). Hoses are available from ZOLL, or a suitable
alternative as described below can be used as indicated in the table below.
High Pressure Hoses need to comply with ISO standards
Product Overview
Device Side
Connections
DISS 6 ft (maximum 20ft)
Green or White (as determined by local regulations)
Non-conductive
Hose Attributes Supply Side Connections
Quick Disconnect, DISS, etc.
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Product Overview
Figure 2-1 Ventilator Gas Sources
Ventilator Circuits
The ZOLL Ventilator operates using a standard disposable ventilator circuit.
The Ventilator circuit attaches to the device using three ports on the top of the device.
• Gas Output -- connects to the ventilator circuit using 22 mm ID corrugated hose. The
connector is a 22 mm male conical connection.
• Transducer (Patient Airway Pressure) -- connects to the ventilator circuit using a
3/16 inch ID transducer tubing. The barb-type connector is colored a green/blue to
distinguish it from the other connectors.
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Product Overview
• Exhalation Valve -- connects to the ventilator circuit using 1/4 inch ID exhalation valve
tubing. The barb-type connector is clear anodized aluminum to distinguish it from the other
connectors (the 1/4 inch ID ventilator circuit exhalation valve tubing is clear).
Ventilator Circuit Connections
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Product Overview
Ventilator Circuit Types
The ZOLL Ventilator can use 6 ft or 12 ft ventilator circuits to support adult, pediatric, and
infant patients.
:
Ventilator Circuits
ZOLL provides the following circuit types:
• Pediatric/Adult, 6 ft (REF 820-0106-XX)
Infant/Pediatric, 6 ft (REF 820-0107-XX)
•
•
Pediatric/Adult, 12 ft (REF 820-0130-XX)
Infant/Pediatric, 12 ft (REF 820-0131-XX)
•
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.
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Product Overview
Heat and Moisture Exchangers (HMEs)
Heat and Moisture Exchangers (HMEs) can be used with the device. While HMEs may not be
suitable for all applications, they facilitate potability in a way that conventional humidifiers
cannot. The unit can be used with 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 heat
and moisture contained in the patient's exhaled gas. Be sure to follow all instructions provided
by the manufacturer.
Note: Use of the HME/HMEF will cause a slight increase in the inspiratory effort to trigger
an Assisted Breath (approximately 1 cm H
Note: ZOLL does not offer a heated humidification option for the device.
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 than 25% of the set
Tidal Volume. Always select an HME/HMEF that is appropriate for the patient. For
very small tidal volumes (50 to 70 ml), it may not be advisable to use an HME.
Warning! Always monitor the patine 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.
O)
2
Pulse Oximeter Sensors
The Masimo Pulse Oximeter is an optional function of the ZOLL Ventilator. When the
appropriate sensor is connected, the pulse oximeter provides continuous noninvasive
monitoring of arterial hemoglobin (SpO
adult, pediatric and infant patients.
The Masimo LCSN series of probes are approved for use with the ventilator. The Accessory
table in Appendix A lists the sensors which are available for use with the ZOLL Ventilator.
Power Sources
The ZOLL Ventilator can operate using external power or it can operate powered by its internal
Li-ion Battery.
The external AC/DC Power Supply that ZOLL provides with the ventilator delivers a DC input
to the device of 24V at 4.2A. When this external power source is present, the ventilator
automatically charges its internal battery while operating.
The external AC/DC Power Supply is a universal supply that can operate with an input of
100-240 VAC 50/60 Hz. The external supply can also power the device when provided with a
400 Hz input.
You should only use the external power supply provided with the ventilator when connecting to
AC power. This power supply provides both Class I and Class II protection.
) and pulse rate (measured by the SpO2 sensor) for
2
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Product Overview
Operating Using External DC Power
The ZOLL Ventilator can also operate using external DC power. When connected to a standard
vehicle DC outlet using either the 12 or 28 VDC Power Cable that ZOLL provides, the
ventilator automatically charges its internal battery while operating.
Note: The input connector of the ventilator accepts DC voltages between 11.8 to 30.0 VDC.
Caution When using the standard vehicle DC outlet, do not jump start the vehicle during operation of the
ventilator.
Operating Using Battery Power
When an external power failure occurs, the ventilator automatically switches to its internal
battery for operating power and activates the EXTERNAL POWER FAILURE alarm; there is no
interruption in operation or loss of any alarms. When external power returns, operating power
automatically switches to the external power source.
In the event that the ventilator needs to be shutdown, turn the POWER switch to the OFF ("O")
position. If this fails to work or puts the patient or operator at possible risk, disconnect the
device from the external power source.
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Chapter 3
Setting Up the ZOLL
Ventilator
This chapter describes how to set up the ZOLL Ventilator. It lists the tasks required to set up the
ventilator for safe, effective use, and describes each task in detail.
Warning! You must always properly set up the ventilator before use. Failure to do so can result in
inadequate care or death of the patient.
To set up the ZOLL Ventilator, you must perform the following tasks:
1. Attach the Ventilator Circuit
2. Attach the High Pressure Oxygen Supply (Optional)
3. Inspect Fresh Gas Intake Filters
4. Connect Fresh Gas Intake Attachments
5. Select the Ventilator’s Power Source
6. Power on the Ventilator
7. Select Start Up Default Values
8. Select Operating Mode (Optional)
9. Change Parameter Values
10. Change Ventilator Settings
11. Change Device Main Menu Options
12. Perform Operational Test
13. Attach the Pulse Oximeter Probe (Optional)
14. Attach Patient
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Setting Up the ZOLL Ventilator
We describe how to perform these tasks in the following sections of this chapter.
Warning! Always follow standard of care, which includes preparations to bag the patient.
DO NOT start up the ventilator with the patient attached.
1. Attach the Ventilator Circuit
Select the correct ventilator circuit for the patient and environment (as we describe in the
previous chapter). Always follow the instructions included with the circuit.
Attach the ventilator circuit to the ventilator’s top panel. Connect
• The 22 mm corrugated hose to the ventilator’s gas output
• The green/blue 3/16 inch ID airway pressure line to the pressure transducer
• The clear 1/4 inch ID exhalation valve control line to the exhalation valve fitting.
Ventilator Circuit Device Connections
Warning! Adult patients should only be ventilated with Pediatric/Adult circuits. Infant patients
should only be ventilated with Infant/Pediatric circuits.
Warning! If circuits with different resistance/compliance are used or additional accessories are
placed in line with the circuit, you must use the appropriate compliance factors for the
new circuit, and that the dead space volume of the added accessories are considered so
that the device delivers effective tidal volume to the patient.
Warning! Dead space increases with mask ventilation; always follow the mask manufacturer's
directions.
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Setting Up the ZOLL Ventilator
Oxygen Inlet
Fresh Gas Intake
2. Attach the High Pressure Oxygen Supply (Optional)
Since the ventilator includes an internal compressor, the attachment of a high pressure oxygen
supply is optional. Review the high pressure supply requirements that we describe in Chapter 2,
and use the oxygen hose to attach the ventilator’s oxygen inlet to the high pressure gas source.
Note: Use only with medical-grade (USP) oxygen. When using with an oxygen cylinder, the
cylinder must be secured.
The O
Hose is either colored green or white, depending on country specifications.
2
3. Inspect Fresh Gas Intake Filters
The fresh gas intake is the gas source for the ventilator’s internal compressor. The ventilator
normally operates with two built-in filters:
1. Removable Foam Filter (
2. Fresh Gas Intake Disk Filter (REF 465-0027-00)
Inspect the filters and, if dirty, replace them (See Chapter 7, “Replacing the Ventilator’s
Filters”).
REF 465-0028-00)
Warning! Never block the Fresh Gas/ Emergency Air Intake, A free flow of air is required during
compressor operation or in the event of 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.
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Setting Up the ZOLL Ventilator
4. Connect Fresh Gas Intake Attachments
The operating environment of the ventilator may require you to connect the following
attachments to the Fresh Gas Intake:
Oxygen Reservoir Bag
If the ventilator will use oxygen from low-flow sources, you may choose to attach an Oxygen
Reservoir Bag Assembly (
Warning! Always monitor the patient and ventilator when using restrictive external filters or the
external O
when the device’s parameter configurations require high oxygen flow.
Reservoir. Changing modes can trigger false compressor failure alarms
2
Bacterial/Viral (BV) Filter
If the ventilator will operate in an environment where the patient is at risk from cross
contamination or airborne pathogens, you may choose to attach a BV filter (See Chapter 6,
“Using the ZOLL Ventilator in Hazardous Environments”).
REF 704-0004-00).
Chemical/Biological C2A1 Filter
If the ventilator will operate in a contaminated environment, you may choose to attach a
chemical/biological C2A1 filter (See Chapter 6, “Using the ZOLL Ventilator in Hazardous
Environments”).
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5. Select the Ventilator’s Power Source
The ZOLL Ventilator can run using one of the following power sources:
1. Internal 14.4V Li-ion rechargeable battery with 6.75 Ah capacity (fully charged, the battery
provides 10 hours of operation at factory default settings with pulse oximeter operating at
25C).
2. External AC/DC Power Supply that ZOLL provides (100-240 VAC 50/60 and 400 Hz with
an IEC 320 style AC input connector. The AC/DC Power Supply provides a DC output of
24V at 4.2A.
3. External DC power from a standard vehicle DC outlet using either the 12 or 28 VDC Power
Cable that ZOLL provides to connect the ventilator to the DC outlet. The ZOLL Ventilator’s
input connector accepts DC voltages between 11.8 to 30.0 VDC.
4. An external battery.
The ZOLL Ventilator uses external power when available rather than its internal battery pack.
When an acceptable external power source is present, the ventilator automatically charges the
internal battery while the device operates. When an external power failure occurs, the device
automatically switches to its internal battery for operating power and activates the EXTERNAL
POWER FAILURE alarm; there is no interruption in operation or loss of any alarms. When
external power returns, operating power automatically switches from internal power to the
external source.
Setting Up the ZOLL Ventilator
In the event that the device needs to be shutdown, turn the POWER switch to the OFF (“O”)
position. If this fails to work or puts the patient or operator at possible risk, disconnect the
device from the mains power.
To connect the ventilator to an external power source, connect an AC/DC Power Supply plug to
the device’s External Power Input and an acceptable electrical outlet.
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Connecting the Power Supply
Connect the external power cable to the ventilator as follows:
Connecting and Disconnecting the Power Supply
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.
Power Supply Latching
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6. Power On the Ventilator
To power on the ventilator, turn the POWER switch to “1”.
After powering on, the device performs its Self Check procedure, which checks for preexisting
alarm conditions and the operation of the pneumatic system, internal communications, and
power system. After completing the Self Check, the ventilator waits for the user to select a
mode before it begins to operate and monitors the presence of alarms continuously.
Setting Up the ZOLL Ventilator
Power Switch
During normal start-up, the ventilator’s alarms are disabled for 15 seconds to allow you to
properly adjust the patient circuit, pulse oximeter, and ventilator settings without distraction. In
the event the ventilator sees alarms at startup, alarms are muted for 120 seconds to allow the
user to address the alarm conditions.
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.
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7. Select Start Up Default Values
When you power on the ventilator, the Start Menu appears, from which you choose appropriate
parameter default values for the patient. You can select these patient parameter defaults:
Note: The ventilator can may be configured to automatically select the Adult parameter
defaults at start up.
• Adult
• Pediatric
• Mask CPAP -- Continuous Positive Airway Pressure (CPAP)
• Custom -- Values saved in a previous session
• Last Settings -- Values set for the patient last using the device before powering down
Note: Gas flows at start up to detect the patient in event proper procedures are not followed.
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.
Adult Default Parameter Values
The Adult default parameter values are as follows:
Mode AC (V)
BPM 12
I:E 1:3
VT 450
PEEP 5
PIP Limit 35
FIO2 21
Pediatric Default Parameter Values
The Pediatric default parameter values are as follows:
Model EMV+, Eagle II AEV
Mode SIMV (P) AC(P)
BPM 20
Ti 0:6
PIP 20
PEEP 4
PIP Limit 30
FIO2 21
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Mask CPAP Default Parameter Values
The Mask CPAP default parameter values are as follows:
Mask CPAP Parameter Start-Up Defaults
Mode CPAP
Backup BPM 12
Backup I:E 1:3.0
Backup PIP 20
PEEP 5
PIP Limit 30
FIO2 21
To select the device’s default parameter values, highlight one of the above settings in the Start
Menu and press the Confirm button. To operate with parameter values that differ from the
default values, use the device’s Parameter buttons (see the “Changing Parameter Values”
section later in this chapter).
Note: You can configure the ventilator to automatically select Adult parameter defaults at
start up.
Warning! Never use the Noninvasive Positive Pressure Ventilation (NPPV) modes on a patient
that is NOT spontaneously breathing and/or may stop spontaneously breathing. CPAP
and BL are intended for ventilatory support, NOT ventilation.
When an NPPV mode is in operation, the head with mask icon appears in the location used by
the speaker/mute icons. Low and Medium priority alarms cause this head with mask icon to
disappear.
It reappears when Low priority alarms are muted.
When Medium priority alarms are muted, the muted speaker icon appears.
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8. Select Operating Mode (Optional)
The ventilator offers four operating modes that you can select to optimally manage the patient
(each mode can use either pressure or volume targeting):
1. AC (Assist/Control) -- 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.
2. SIMV (Synchronized Intermittent Mandatory Ventilation)-- The patient receives controlled
breaths based on the set breathing rate. Spontaneous breaths are either unsupported demand
flow or supported using Pressure Support. (This mode is not available in the AEV
3. CPAP (Continuous Positive Airway Pressure) -- The patient receives constant positive
airway pressure while breathing spontaneously. Spontaneous breaths are either demand flow
or supported using Pressure Support.
4. BL (bilevel) -- the ventilator provides two pressure settings to assist patients breathing
spontaneously: a higher inhalation pressure (IPAP) and a lower exhalation pressure (EPAP).
To select the operating mode, press the Mode parameter button, turn the Dial to highlight the
mode you want to use, and press the Confirm button.
When transitioning from active ventilation to NPPV modes, or from NPPV Modes to active
ventilation modes, the following parameter/alarm limit may be adjusted:
®
device.)
Alarm/Parameter
Low BPM Alarm
High BPM Alarm
Low Airway Pressure Alarm
PEEP
V
High Limit
T
V
Low Limit
T
Rise Time
Pressure Support
Warning! The transition into NPPV automatically sets the rise time to 3, which may be too fast for
infants and small children. Before using the ventilator with an infant or small child, you
should always configure the ventilator appropriately before attaching the patient.
Note: An alarm triggers when you connect the patient to the ventilator while the Start Menu
is still active. To resolve the alarm, you must select a mode of ventilation and configure
the device appropriately for the patient. In addition, you should perform the
Operational Test procedure before reconnecting the patient to the device.
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9. Change Parameter Values
If the patient requires parameter values that differ from the default values, you can use the
parameter buttons to change these values, as necessary. To change the parameter values, press
the Parameter buttons to display the primary parameter and secondary parameter values, or
Press and hold the parameter button to display the parameter’s context menu. Use the Dial to
adjust the highlighted parameter. Press the Confirm button to implement the change.
Warning! Avoid high airway pressure as this increases the risk of aspiration.
Warning! The alarm limits must be appropriate for the patient being monitored. If a parameter is
changed, adjust the high and low alarm limit to bracket selected value.
10. Change Device Settings
The Main Menu button displays the Main Menu, which allows you to change various
Ventilator settings, such as the contrast or brightness of the device’s Display Screen (LCD
Contrast/LCD Brightness).
When you press the Main Menu button, the main menu appears:
• Alarm Config
• Powerup Settings
• LCD Contrast
• LCD Brightness
• UTC Offset
• Unit Info
• Alarm History
Alarm Configuration
Selecting Alarm Configuration allows the operator to enable or disable the audible and visible
alerts associated with specific alarms to prevent nuisance alarms.
Refer to, “Alarm Cancellation in Alarm Configuration Menu” in Chapter 4.
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Powerup Settings
You can configure how the device starts (powers up) based on your use or patient population.
The device Powerup settings (options) include:
Powerup Setting
(Option)
Powerup Adult, Pediatric, or Start Menu
Custom Settings Save the currently set operating parameters if different that the Adult or
Language English, Language Option
Setting Choices
Pediatric defaults
In addition to controlling how the device starts up, the Powerup settings sub-menu also allows
the user to save the current device configuration for use as the Custom starting configuration and
which language will be used when the device starts.
Specifying Powerup Settings
To configure new Powerup settings, follow these steps:
1. Press the Main Menu button to display the Main Menu, then turn the Dial to highlight
Powerup Settings.
2. Press the Confirm button. The following list of configurable alarms items with
Powerup highlighted.
• Powerup
• Custom Settings
• Language
3. Press the Confirm button, then turn the Dial to the desired starting configuration.
• Adult (default)
• Pediatric (default)
• Start Menu
4. Press the Confirm button to confirm the new starting configuration.
5. Press the Mute/Cancel button to return to the Main Menu.
6. Press the Mute/Cancel button again to return to the configured Powerup setting (Start
Menu, Adult, or Pediatric).
Specifying Custom Settings
To save the current configuration (if different than Adult or Pediatric default parameter
settings) for use at start up, follow these steps:
1. Press the Main Menu button, then turn the Dial to Powerup Settings, then press the
Confirm button.
2. Turn the Dial to highlight the Custom Settings choice, and then press the Confirm button
(Save becomes highlighted).
3. Press the Confirm button again to save the current parameter settings.
4. Press the Mute/Cancel button to return to the Main Menu.
5. Press the Mute/Cancel button again to return to the configured Powerup setting (Start
Menu, Adult, or Pediatric).
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Specifying a Language
The device is provided with the English language. (This feature is limited to devices with
multiple languages)
LCD Contrast
The LCD Contrast choice allows the user to adjust the contrast of the ventilator display screen
to optimize visibility in the current lighting environment. Given the use environment, the device
automatically compensates for the temperature changes that can effect LCD performance. However, in
temperatures outside its performance specification, -26° C to 55° C, or when the device temperature is
rapidly changing (warm storage into a very cold environment) the contrast can fad making viewing
difficult. The initial contrast value is 0 and rangers from -42° C to 42° C.
To adjust the LCD screen contrast, follow these steps:
1. Press the Main Menu button to display the menu.
2. Turn the Dial to highlight LCD Contrast, and then press the Confirm button.
3. Turn the Dial clockwise to increase contrast (counterclockwise to decrease it) while watching
4. Press the Mute/Cancel button to return to the configured Powerup setting (Start Menu,
Note: The contrast value is saved between uses. This may require that the contrast value be
Note: In the event the LCD is not viewable due to extreme temperature conditions there is a
Setting Up the ZOLL Ventilator
the LCD screen to determine the best contrast value based on visibility, then press the
Confirm button to set the new contrast value.
Adult, or Pediatric).
readjusted when the temperature is within the device operating range or with the next
use.
short cut to the contrast control. Press and hold the Main Menu button for 2 to 3
seconds. Doing this, jumps the menu highlight directly to the contrast control where
the contrast can be adjust as described above.
LCD Brightness
The LCD Brightness control allows the user to adjust the brightness of the LCD display screen
to optimize visibility in the current lighting environment.
The initial numerical value is 25. The brightness ranges from 0 to 31.
To adjust the LCD screen brightness, follow these steps:
1. Press the Main Menu button to display the menu.
2. Turn the Dial to highlight LCD Brightness, and then press the Confirm button.
3. Turn the Dial clockwise to increase brightness (counterclockwise to decrease it) while
watching the LCD screen to determine the best contrast value based on visibility, then press
the Confirm button to set the new contrast value.
4. Press the Mute/Cancel button to return to the configured Powerup setting (Start Menu,
Adult, or Pediatric).
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UTC Offset
The UTC Offset control allows the user to set the ventilator clock to match the local time zone
relative to Coordinated Universal Time (UTC). Matching the local time zone through the
UTC Offset setting allows an accurate time record of events recorded in the alarm log.
Before setting the UTC Offset, the user must know the UTC Offset value for your timezone.
When determining the UTC Offset value, remember to consider variances for Daylight Saving
Time (DST).
Unit Info
Once set,
• You change the setting (required for daylight savings time)
• The device is serviced.
the setting is retained until:
To adjust the UTC Offset, follow these steps:
1. Press the Main Menu button to display the menu.
2. Turn the Dial to highlight UTC Offset, and then press the Confirm button.
3. Turn the Dial clockwise or counterclockwise to find the offset value for your timezone, then
press the Confirm button to set the new contrast value.
4. Press the Mute/Cancel button to return to the configured Powerup setting (Start Menu,
Adult, or Pediatric).
The Unit Info choice allows the user to view the following information abut the ventilator as
follows:
Item Description
Use Statistics Provides access to ventilator usage in hours and minutes.
Date The current calendar date
Cal Date Last date the calibration was checked
PM Cycle Annual, Stockpile I, stockpile II
SPM SW Rev Software revision of the Smart Pneumatic Module
SPM SN Serial number of the Smart Pneumatic Module
SPM Model Smart Pneumatic Module model
EMV Soft Rev Software revision of the ventilator model
Device SN Serial number of the ventilator model
Device Model Ventilator model
To view unit information for the ventilator, follow these steps:
1. Press the Main Menu button to display the menu.
2. Turn the Dial to highlight Unit Info, and then press the Confirm button. The list of
information displays with Use Statistics highlighted.
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3. Press the Confirm button to display ventilator usage in hours and minutes (hh:mm)
4. Press the Mute/Cancel button to return to the configured Powerup setting (Start Menu,
Alarm History
The Alarm History provides a list of the alarm messages generated by the ventilator during use.
The history holds a maximum of 256 events.
Note: Power cycling does not clear the alarm history
Each list entry provides the following information
• The Alarm Name
• The Service Code
• The calendar date the event was entered
• Whether the alarm is set or cleared
• The log entry number <NNN> The higher the number the more recent the alarm message
To adjust the GMT Offset, follow these steps:
1. Press the Main Menu button to display the menu.
2. Turn the Dial to highlight Alarm History, and then press the Confirm button. the most
3. Turn the Dial counterclockwise to view earlier entries. Turn the Dial clockwise to view more
4. Press the Mute/Cancel button to return to the Main Menu.
5. Press the Mute/Cancel button again to return to the configured Powerup setting (Start
Setting Up the ZOLL Ventilator
Adult, or Pediatric).
event was logged
recent history entry displays.
recent entries.
Menu, Adult, or Pediatric).
The alarm condition is not logged when alarm is active but not displayed (due to other higher
priority alarm indication as explained in the Alarms Chapter of this manual), or if the alarm is
disabled in the alarm configuration the condition is not logged.
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11. Perform Operational Test
Before attaching the patient to the ventilator, you must perform an Operational Test to ensure
that the breathing circuit is properly attached and that the primary patient safety alarms, such as
PATIENT DISCONNECT and AIRWAY PRESSURE HIGH are functioning properly.
Operational Test Procedure
Press the MANUAL BREATH button; gas should flow out of the patient connection each time
the button is pressed.
The minimum period between manual breaths is limited by the tidal volume and the time
required to complete a full exhalation based on the I:E ratio.)
Close the patient port with a gloved hand. During inspiratory phase, the HIGH AIRWAY
PRESSURE LIMIT alarm should activate after 2 breaths that reach the PIP High Limit.
If the AIRWAY PRESSURE HIGH alarm fails to activate, ensure that all of the tubing
connections are secure, the exhalation valve is closing during inhalation, and that the High
Airway Pressure Limit is set to 35 cm H2O or less.
After a breath or two, release the patient port while allowing the ventilator to operate. The
PATIENT DISCONNECT alarm should activate.
Partially close the patient port to reset the PATIENT DISCONNECT alarm. With no other
alarms occurring, remove external power from the ventilator. The EXTERNAL POWER
LOW/DISCONNECT alarms should activate. Reconnect external power to reset alarms.
If either the HIGH AIRWAY PRESSURE, PATIENT DISCONNECT, or EXTERNAL POWER
LOW/DISCONNECT alarms fail to activate, continue to manually ventilate the patient, replace
the ventilator, and send the device in for service.
If operating using the internal battery, verify that the Battery icon indicates sufficient available
battery capacity remains to support the anticipated duration of operation. If not, begin
ventilation and find an alternate source of power.
The trigger automatically adjusts when the PEEP is changed.
Until you have determined that the ventilator is functioning properly and that the ventilator
parameters are set correctly for the patient, do not connect the patient to the ventilator.
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12. Attach the Pulse Oximeter Probe (Optional)
The pulse oximeter becomes operational in all ventilator modes when its cable and sensor are
properly attached to the SpO
SpO2 and HR Parameter Windows display stby).
connector (during start up, the pulse oximeter is on standby -- the
2
To operate the pulse oximeter, connect the sensor probe to the patient and the cable to the SpO
connector on the top of the ventilator as shown in the following illustration:
2
Connecting the Pulse Oximeter Sensor
The monitoring function begins automatically when a valid patient signal is detected for > 10
seconds.
For more information about the Masimo pulse oximetry technology that the ZOLL Ventilator
uses, see Appendix C, Pulse Oximeter Principles.
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13. Attach Patient
After you confirm that the ventilator is operating correctly, detach the test lung (if used in the
Operational Test) from the ventilator circuit.
Attach the patient to the ventilator using the appropriate connector (endotracheal tubes, trach
tubes, subglottic airways or a laryngeal mask) to the ventilator circuit.
Warning! Never leave the patient unattended.
Warning! Always assure that there is an alternate means of providing mechanical ventilation. A
bag-valve resuscitator and an appropriate mask for the patient being ventilated should
be immediately available.
Warning! Do not connect the patient to the ventilator until the operator has determined that the
ventilator is functioning properly and that the ventilator parameters are set correctly
for the patient, the patient.
Warning! Do not connect anything to the USB connection.
The USB connection does not provide any signal output or input to the operator. The
USB connection is a tooled access used by service.
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Chapter 4
Using the ZOLL Ventilator
This chapter describes how to use the ZOLL Ventilator.
Effective operation of the ventilator requires understanding of the following information:
• The ZOLL Ventilator Interface and Parameter Windows
• Changing Parameter Values
• Selecting Ventilation Mode Options
• Using the Pulse Oximeter
• Managing Pop Up Messages
• Managing Alarms
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Using the ZOLL Ventilator
The Ventilator Interface
The ZOLL Ventilator uses a Graphical Use Interface (GUI) to display the parameter settings
and patient readings.
Changing Parameter Values
The ZOLL Ventilator helps you to manage the patient by organizing ventilatory parameters in
parameter windows on the right side of the display screen. These parameter windows display
the primary and secondary parameters and the alarm settings for that parameter. In addition, set
values and measurements appear in the auxiliary boxes at the bottom of the display screen.
Additional settings used to manage the patient are applied using the context menu for parameter
group.
The sections below describe the parameter windows and the associated context menus for each
parameter. A table addresses availability of the parameter and its use in the device models.
The parameter window values are chosen with the parameter button:
Single Press: chooses primary parameter
Multiple Presses: chooses the secondary parameter and alarm limits
Press and Hold: chooses the context menu
To prevent setting of parameter values that are outside the typical clinical range of settings, the
ZOLL Ventilator displays Pop Up messages that ask if you are sure you would like to set the
parameter beyond the typical range. We describe Pop Up messages in more detail in Chapter 5.
Parameter Buttons
The parameter windows, from lowest to highest, are
• Mode
• BPM (Breaths per Minute)
• Vt (Tidal Volume -- V
• PIP (Peak Inspiratory Pressure)
• FIO2
• SpO2
• HR (Heart Rate)
Mode
The ZOLL Ventilator allows you to select different ventilation modes that you can select to
optimally manage the patient:
• AC (Assist/Control) -- 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.
• SIMV (Synchronized Intermittent Mandatory Ventilation) -- The patient receives
controlled breaths based on the set breathing rate. Spontaneous breaths are either
unsupported demand flow or supported using Pressure Support.
)
T
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• CPAP (Continuous Positive Airway Pressure) -- The patient receives constant positive
airway pressure while breathing spontaneously. Spontaneous breaths are either demand flow
or supported using Pressure Support.
• BL (Bi Level) -- the ventilator provides two pressure settings to assist patients breathing
spontaneously: a higher inhalation pressure (IPAP) and a lower exhalation pressure (EPAP).
Press the Mode parameter button to highlight the current ventilation mode. Press the Mode
parameter button again to select volume or pressure targeting which is shown as either “(V)”
for volume or “(P)” for pressure.
Breath Target
The selected ventilation mode, and the selection of breath target (volume or pressure)
predetermines the parameter availability for the BPM, Vt, and PIP parameter windows.
Volume targeting assures a constant volume is delivered to the patient in the inspiratory time
using a constant flow.
Pressure targeting provides a constant airway pressure for the duration of the inspiratory time
Warning! During pressure-targeted ventilation, always set the high tidal volume just above the
patient's 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.
Leak Compensation
Leak Compensation provides flow during the expiratory phase to maintain the baseline
pressure in patients that are breathing spontaneously, but have a leaking airway or facemask.
To avoid nuisance alarms in patients with active leaks, Leak Compensation suppresses the
following alarms:
• Low Airway Pressure (# 2071)
• High Tidal Volume (# 2072)
• Low Tidal Volume (#2073)
The following table lists the ventilator modes and their availability in the ZOLL ventilator
models, and gives the options and ranges for the ventilation mode parameters:
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Parameter Window Options /
Availability/Notes Models
Range
Primary Value Mode AC All
SIMV EMV+, Eagle II
CPAP All
BL All
Secondary
Target (V) or (P) AC and SIMV modes All
parameter Values
(SIMV not available
with AEV)
LC On or OFF
Default off
AC(P), SIMV(P) modes EMV+, Eagle II
BL modes All
CPAP
Default on
Alarms N/A
Measured Value N/A
Apnea Back Up Context Menu CPAP and BL modes
Apnea Back Up BPM 1 to 80 All
Apnea Back Up PIP 10 to 80 All
Apnea Back Up I:E , Ti 1:1 to
Control selected in context BPM Context Menu
1:99, 0.1 to 3
Warning! These Apnea backup settings are appropriate for adult patients.
For pediatric patients, adjust the Apnea backup settings so that they are appropriate
for the pediatric or infant patient.
All
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BPM (Breathes Per Minute) -- Timing and Rate Management
The BPM parameter describes the number of breaths-per-minute. The selected ventilation
mode determines when this value is a setting or a measurement.
Assisted and controlled breaths are time-cycled. For spontaneous breaths, the ventilator uses
the percent of the peak flow to terminate the breath being delivered (flow cycled).
Control Parameter
The Ti (Inspiratory Time) parameter adjustment sets the inspiratory time for the control and
assisted breaths (AC and SIMV modes). For volume targeted breaths, the Ti parameter affects
the gas flow rate (the device displays Pop-Up messages when the minimum and maximum flow
rate values have been reached).
Rise Time
When PS is selected, you can adjust the time it takes to reach PIP. You can specify an index of
1 (shortest) to 10 (longest). The device uses the PIP waveform as a reference when selecting the
Rise Time for the patient.
You should reassess and readjust the Rise Time settings after the patient is placed on the
ventilator and initially stabilized. To minimize patient's work of breathing and potential for
pressure overshoots, you must take the following into consideration when setting the Rise
Time:
• Patient's respiratory pattern
• Patient's comfort
• Patient's 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 RiseTime
51
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 to 10 are optimized for infants and are flow limited.
(The infant circuit is not intended for flows > 60 LPM.)
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Cycle Off % Parameter
The ZOLL Ventilator transitions from inspiratory to expiratory phase when the flow drops
below a set percentage of the peak flow.
You can adjust the Cycle % value to account for patient leaks.
Note: The longest duration of a spontaneous breath is 5 seconds. At the end of this time, the
ventilator ends flow and opens the exhalation valve.
Clinicians must carefully assess the patient's response when applying the adjusted % -- you
must adjust the % value carefully to optimize patient ventilatory support and comfort.
The Cycle Off % parameter is principally for noninvasive modes 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 system tends to time cycle at 5 seconds instead of flow cycle (if the leak
flow is higher than 25% of the peak flow, the cycle threshold is never crossed.)
If there is no leak, increasing the Cycle Off % parameter causes breaths to cycle sooner, and
deliver less volume. If you set the Cycle Off % parameter too high, the breath ends early
relative to patient effort, which may lead to the triggering of a second breath.
Spont Ti Limit Parameter
The Spont Ti Limit parameter provides an additional method to operate the delivery of breaths
and maximize patient comfort.
Manual Breath/Plateau Pressure Button
The Manual Breath/Plateau Pressure button delivers a breath only if pressed during the
expiratory phase when the airway pressure drops to the PEEP target.
In AC and SIMV, pressing the Manual Breath/Plateau Pressure button delivers a breath defined
by the settings.
In CPAP and BL, pressing the Manual Breath/Plateau Pressure button delivers a breath defined
by Apnea Back-Up settings.
Press and hold the Manual Breath/Plateau Pressure button to perform a plateau pressure
maneuver.
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BPM Parameter Settings
The following table gives the options and ranges for the BPM parameters:
Using the ZOLL Ventilator
Parameter Window Options /
Range
Primary Value BPM
Breaths per
minute
Secondary
parameter Values
Alarm Limits High breath rate 20 to 99, off
Measured Value Minute Volume
BPM Context Menu
Ti (sec)
|or
I:E
Low breath rate 2 to 40
Vmin (ml)
0 to 80 Volume Target: Control Setting
Ti 0.1 to 3.0
or
1:1 to 1:99
Ti 0.1 to 5.0
or
I:E 4:1 to 1:99
0 to 99.9
Availability/Notes Models
All
Pressure Target: Measured
See BPM context menu: Control Parameter
Inverse I:E EMV+,
All
Eagle II
Control
Parameter
Rise Time - Default 3 1 to 10 Auxiliary Box All
Cycle Off %
(% Cycle )
Spont Ti Limit Default
Default I:E 1:1 to
1:99, 0.3 to 3
Ti 0.1 to 5.0
or
I:E 4:1 to 1:99
Default 25% 10 to 70% Auxiliary Box All
0.30 to 4.00
Adult = 3.00
Infant = 2.00
Mask CPAP =
3.00
The control value is shown in
the Parameter window, the
dependent value is shown in the
Auxiliary Box.
Inverse I:E EMV+,
All
Eagle II
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Vt (Tidal Volume)
The Vt parameter gives the tidal volume (ml) delivered to the lung. The selected ventilation
mode determines if this value is a setting or a measurement.
In volume targeted modes, pressing the VT parameter 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.
Warning! In NPPV, a VT that is lower than anticipated given the patient's size may be an
indication that the patient is not able to adequately spontaneously ventilate.
The ventilator circuit is part of the breathing system of the ventilator. Tubing compliance of the
circuit is a physical property that affects the tidal volume delivered to the patient. The ZOLL
Ventilator allows you to adjust the compliance value of the circuit (see Chapter 6 for more
information).
Note: In the CPAP-NPPV, the V
volume going to the patient when leaks are present. The O
display the O
use, though the amount used is more than if no leak was present.
2
delivered and V
T
may be overestimates of the true
min
Use values accurately
2
Warning! If significant leaks are present during NPPV modes, the VT delivered and V
may be overestimates of what is actually being delivered to the patient. The adequacy of
ventilation should be assessed using an alternate method.
min
shown
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The following table gives the options and ranges for the Vt parameters:
Parameter Window Options /
Availability/Notes Models
Range
Primary Value Vt
ml
50 to 2000 Volume Target: Control Setting
Pressure Target: Measured
All
Secondary
Alarm Limits High Vt 50 to 2000,
Off
Low Vt 5 to 500,
Off
Vt Context Menu
Tubing Compliance (CT)
Adult Default: 1.60 0 to 3.50 The changed value is not
Default : Off OFF, Adult,
Infant
Auxiliary Box All
All
retained when the device is
Infant Default: 0.50 0 to 2.00 All
Compliance
Volume (ml)
(Measured
value )
0 to 349 All
turned OFF
PIP (Peak Inspiratory Pressure) -- Pressure Management
In volume targeted modes, the primary field shows the delivered PIP as outline text. In pressure
targeted modes, the PIP target is displayed and is adjustable. The PIP High Limit, PIP Low
Limit, and PEEP are also available as secondary parameters.
During the exhalation phase, the ventilator opens the exhalation valve when the pressure is
above the PEEP setting, and closes it when below the setting.
In Bilevel Ventilation Mode, the ventilator provides noninvasive ventilation with the ability to
manage the patient by adjusting the IPAP and EPAP parameters.
Caution Set the trigger level to minimize the work of breathing for the patient and prevent
auto-triggering. Set the Vt alarms to bracket average tidal volume so that the device detects
pending respiratory failure (low tidal volumes) and excessive leaks (high tidal volumes).
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Spontaneous/Assisted Breath Trigger
The Spontaneous/Assisted Breath Trigger is preset to -2.0 cm H2O and can be adjusted from-
6.0 to -0.5 cm H2O below the baseline (PEEP) pressure. In order to initiate a spontaneous or
assisted breath, the patient must generate -2.0 cm H2O. When the pressure drop is detected, an
assisted breath is delivered.
The trigger automatically adjusts when the PEEP is changed.
Warning! Set the trigger level so as to minimize work of breathing and prevent auto-triggering.
When ventilating infants and other patients with weak inspiratory effort, lower the
trigger threshold (> 2cm 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.
Plateau Pressure
Press and hold the Manual Breath/Plateau Pressure button to perform a plateau pressure
maneuver.
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Pressure Management
The following table gives the options and ranges for PIP and other pressure settings.
Using the ZOLL Ventilator
Parameter Window Options /
Availability/Notes Models
Range
Primary Value PIP
cm H2O
Secondary
Value
Alarm Limits High PIP 20 to 100 PEEP cannot be within 5 cm H
Measured Value Mean Airway Pressure
PEEP 0 to 30 AC Modes (ACV, SIMV, CPAP, BL
PS 0 to 60 Spontaneous Breaths
EPAP 3 to 30 Spontaneous Breaths
IPAP 6 to 60
Low PIP 3 to 35, Off All
10 to 80 Volume Target: Measurement
Pressure Target: Control Setting
PIP values greater than 60 cm H2O
require the operator to perform a separate
confirmation.
Modes
3 to 30
(SIMV and CPAP )
BL
the PIP High Limit setting.
0 to 99.9 All
O of
2
All
All
All
All
MAP
Paw Waveform 0 to 100 All
PIP Context Menu
Breath Trigger
(Assisted,
Spontaneous)
Default : -2 -6 to -0.5 Adjustment Increments: .5 All
All
Warning! Always set the Low Airway Pressure Limit at least 5 cm H2O above PEEP. Ideally, the
value should be 5 cm H2O < PIP.
Warning! Set the PIP Low Limit to be at least PEEP +5. This reduces the likelihood of not
detecting a kinked hose. Setting the PIP Low Limit to > PEEP and < PIP Low Limit can
also serve as a PIP compensated disconnected threshold.
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FIO2 (Fraction of Inspired Oxygen) -- Oxygen Delivery Management
Pressing the FIO2 parameter button highlights the current FIO2 value and enables you to adjust
it. There are no adjustable secondary parameters. The default values at start up is 21% whether
oxygen is present or not. If an FIO
settings, the device start ups with that saved FIO
high-pressure oxygen is not present, the device starts up with FIO
PRESSURE LOW alarm is not activated. The secondary display in the parameter window is O
Use1. This is the flow (liters/min) of high pressure oxygen used by the device to support the
patient at the current settings. O
sign next to the FIO
oxygen use in the O
The following table lists the options and ranges for the FIO2 parameter:
value when this mode is active. (The “O2 Use” value does not include
2
Reservoir.)
2
value greater than 21% is saved and used for Power Up
2
value if high-pressure oxygen is present. If
2
= 21% and O2 SUPPLY
2
Reservoir mode is indicated on the display with a plus “+”
2
2
ParameterWindow
PrimaryValue FiO2
%
SecondaryValues
AlarmLimits
NotApplicable
NotApplicable All
MeasuredValues O2Use(L/min)
FiO2ContextMenu
O2Reservoir Default:off
Options/
Availability/Notes Models
Range
21to100 Allbreathsaredeliveredfrom
thecompressorat21%
Allbreathsaredeliveredfrom
theHighPressureO2Sourceat
100%
0to99.9
Off / On
Shows when High Pressure
Oxygen Supply is present.
“+”iconindicateswhen“on”for
lowflowoxygen.
All
All
All
All
1. O2 Use = ((FIO2-0.21)/0.79)*Minute Volume where FIO2 is represented as a fraction and minute
volume is the actual minute volume (controlled and spontaneous breaths * tidal volume).
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SpO2 -- Using the Pulse Oximeter
The primary use of the device is as a ventilator -- the pulse oximeter operates only when the
device is providing ventilation.
The following conditions can affect the pulse oximeter reading:
• 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 a SpO2 sensor
attached.
• The patient has hypotension, severe vascoconstriction, severe anemia, or hypothermia.
• There is an arterial occlusion proximal to the sensor.
• The patient is in cardiac arrest or is in shock.
The SpO
standby (and displays stby in the parameter window) when
display is active only when the pulse oximeter is connected. The pulse oximeter is in
2
Using the ZOLL Ventilator
• No SpO
• The sensor is off the patient during start up
• You place the pulse oximeter in standby
sensor is connected
2
Note: You can place the pulse oximeter in standby only when the probe is disconnected from
the patient. A valid signal automatically brings the pulse oximeter out of standby.
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SpO2 Parameter Values
Pressing the SpO2 parameter button highlights the Low SpO2 Alarm Limit and enables its
value to be changed. The default low SpO
the same Context Menu as the HR parameter.
The following table gives the options and ranges for the SpO2 parameter:
Parameter Window Options /Range Availability/Notes Models
value at start up is 94%. The SpO2 parameter uses
2
Primary Value SpO2
84 to 100
%
Secondary
Not Applicable
Values
Alarm Limits Low Limit
Measured
Values
Pleth
Waveform
86 to 99, Off
SpO2 Context Menu (note same
as HR Context Menu)
Pulse Ox Default :
Standby
Standby, Off,
On
Fast SAT Default : Off Off/On
Measurement
Fast SAT enables rapid tracking of
arterial oxygen saturation changes by
minimizing the averaging. This mode is
clinically applicable during procedures
when detecting rapid changes in SpO
is paramount such as induction,
intubation, and sleep studies.
2
All
All
Sensitivity Norm Max
APOD Off Off, On
Averaging 8 Seconds 2 to 4, 4 to 6,
8, 10, 12, 16
Norm adjusts the pleth signal
sensitivity. Max interprets and displays
data for even the weakest of signals.
Max is recommended during
procedures and when clinician and
patient contact is continuous.
When on, this mode improves detection
of the "probe off patient" condition, but
reduces the ability to acquire a reading
on patients of low perfusion.
Adjusts the SpO2 and HR averaging
durations.
Seconds
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Using the ZOLL Ventilator
Signal Strength Measured
Value
Signal IQ Measured
Value
0 to 20
Bar Graph
Current signal strength value, not
adjustable. A value of zero indicates that
no measurement is available. This value
helps clinicians place sensors on
optimal sites
Bar graph displays the relative reliability
of the pulse oximeter signal.
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HR (Heart Rate)
The HR (Heart Rate) parameter window displays the patient’s heart rate when the pulse
oximeter is working and the sensor is attached.
Pressing the HR parameter button highlights the High Heart Rate alarm limit and enables its
value to be changed. Pressing the HR button a second time highlights the current value of the
Low Heart Rate Alarm limit and enables its value to be changed. Both limits are adjustable by
1 b/min. The default value at start up for the high alarm limit is 120 BPM (Beats Per Minute);
the low alarm limit is 40 BPM.
The following table gives the options and ranges for the HR parameter:
Parameter Window Options /
Range
Primary Value HR
Secondary
Values
Alarm Limits High Limit 80 to 240,
Measured
Values
HR Context Menu (note same as SpO2 Context Menu)
%
Not Applicable
Low Limit 30 to 79,
Pleth Waveform
0 to 240 Measurement - Heart Icon blinks
Off
Off
Availability/Notes Models
at the beat rate.
All
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Managing Pop Up Messages
To prevent the setting of parameter values that are outside the typical clinical range of settings,
the ventilator presents Pop Up messages that ask if you are sure you would like to set the
parameter beyond the typical range.
When a message occurs, you are asked to press the Accept/Select button before you can adjust
a parameter beyond the typical range. Pop Up messages are also used to alert you that certain
settings are not permitted. In addition, Pop Up messages can call for you to press Accept/Select
to acknowledge that you are entering configurations where certain alarms are being suppressed,
turned “off”, and/or canceled.
We provide a comprehensive list of pop up messages in Chapter 5, “Alarms.”
Using the ZOLL Ventilator
Pop Up Message Example
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Using the ZOLL Ventilator
Managing Alarms
The ZOLL Ventilator uses Smart Help™ messages that provide a comprehensive suite of
alarms. Smart Help messages alert operators and guide their actions to resolve alarm conditions
and ensure patient safety.
At the onset of an alarm, the screen displays the alarm name and then a series of
context-sensitive Smart Help messages, which describe the possible cause and resolution of
that alarm. When multiple alarms occur, the device prioritizes alarms and displays those alarms
that indicate the greatest risk to the patient first.
Smart Help Example
The previous illustration provides an example of what the device displays when there are
several alarms. The displayed Alarm message corresponds to the dark alarm bell at the bottom
of the display. You can cycle through the various alarms by turning the ventilator’s selection
dial. If there are less than 5 alarms, this alarm list also includes a “plot” icon, where the alarm
screen is replaced by the Pulse Pleth/Time and Pressure/Time plots.
We describe Alarms in detail in Chapter 5, “Alarms” and provide a comprehensive reference.
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Smart Help Messages
a
b
c
d
e
f
At the onset of an alarm, the Alarm Message Center (AMC) in the upper left-hand corner of the
device’s LCD screen displays a Smart Help message. The Smart Help message displays the
alarm name with a series of messages to help the operator resolve the alarm. The AMC
indicates the number of active alarms as a series of Alarm Bell icons at the bottom with each
bell indicating an active alarm. The ventilator prioritizes alarms and displays the alarm
indicating the greatest risk first. All messages are context-based and suggest what is causing the
condition and how it can be resolved.
Using the ZOLL Ventilator
Smart Help Display
Smart Help messages contain the information and instructions for all active alarms, such as in
the previous example:
a. Alarm Name: Describes the nature and/or cause of the fault or failure. The Alarm
Name appears at the top of the AMC. When more than one alarm occurs at the
same time, the device prioritizes them based on patient safety.
b. Mitigation/Resolution Instructions: Instructions for the operator as to how the
alarm state may be resolved.
c. If not Resolved Instructions area: Instructions for the operator on what to do if
they cannot resolve the alarm state. The instruction is always shown in the following
format **Message...**.
d. Alarm Icons: For each active alarm, an alarm bell appears. When multiple alarms
are active, the number of bells corresponds to the number of alarms. The alarm in
the AMC is demonstrated as the solid bell. To view each active alarm, turn the
selection dial to scroll through all active alarms. If there are less then 5 alarms, the
plot icon also appears.
e. Service Code: Each alarm has a 4 digit number associated with it, which helps the
operator indicate the specific alarm when communicating with technical support.
f. Attention Warning Icon: Identifies the severity of the alarm: Low, Medium, or
High priority.
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Alarm Priorities
Alarm priorities define the operational state of the device regarding its ability to provide
mechanical ventilation. The alarm priority determines what effect pressing the
MUTE/CANCEL button has. 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 recurs
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 themselves 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. You can cancel some Low Priority alarms to avoid
nuisance alarms.
If the alarms are Low Priority, then the Pleth and Pressure/Time plots appear permanently on
the screen when the alarms are muted. If the alarms are Medium Priority, the device cycles
through each Medium Priority Alarm for a 20 second period. You can use the selection dial to
select a particular Medium Priority Alarm and/or Plot for 20 seconds, after which the above
cycling rotation resumes. New Alarms can overwrite the screen at any time.
The first digit in the service code indicates the alarm priority:
1###: High Priority alarms
2###: Medium Priority alarms
3###: Low Priority alarms
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Silencing Alarms
The operator may decide, based on their clinical assessment, to silence certain alarms that, in
the given situation, are considered “nuisance” alarms and do not assist in the safe management
of the patient. Before any alarms can be silenced, the operator receives a Pop Up message
asking them to confirm their understanding that the alarm is no longer available in the current
operating session.
Alarm Preemptive Mute upon Power up
When the device is first powered up, certain patient circuit alarms are preemptively muted for
120 seconds, to allow the operator time to get the patient circuit properly adjusted without
nuisance alarms.
Note: During this preemptive mute of this audible alarm, the LED alarm light and alarm
message are still indicated.
There is a countdown timer located under the muted alarm symbol, showing how much time of
the 120 seconds is remaining. The alarms that have this preemptive mute are:
Service Code Alarm Name
2062 Exhalation Fault
Using the ZOLL Ventilator
2070 Airway Pressure High
2071 Low Airway Pressure
2072 High Tidal Volume
2073 Low Tidal Volume
2074 High Breath Rate
2075 Low Breath Rate/Apnea
2076 Apnea
2090 PEEP Leak
2095 Insufficient Flow
2100 Patient Disconnect
2170 Spontaneous Breath-PIP High
2171 Spontaneous Breath-PIP Low
2172 Spontaneous Breath-V
2173 Spontaneous Breath-V
2300 Pulse Ox Module Failed
2301 Internal Communication Failed
High
T
Low
T
2314 SpO2 Sensor Off Patient
2401 SpO2 Low
2410 Heart Rate High
2411 Heart Rate Low (Pulse Rate Low)
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Using the ZOLL Ventilator
Service Code Alarm Name
3300 SpO2 Shutdown (MS 11 Failure-Monitor Not In Use)
3301 SpO2 Shutdown (Communication Failure EMV-Pulse Ox-Monitor Not In
Use)
3310 No SpO2 Sensor Connected (No Sensor Detected)
3311 Defective Sensor
3312 SpO2 Pulse Search
3313 SpO2 Signal Interference
3315 Too Much Ambient Light
3316 Invalid SpO2 Sensor (Unrecognized Sensor)
3317 Low SpO2 Perfusion (Low Perfusion)
3318 Low SpO2 Perfusion (Poor SpO2 Signal
Turning Off Alarms at Extreme Range Limits
If the operator sets the following alarm limits to their extreme range, the ventilator turns off the
indicated alarms after Pop Up message confirmation:
1. High Breath Rate (Alarm #2074).
2. PIP Low (Alarms #2071, 2171) -- the device automatically turns off these alarm limits
in NPPV mode.
3. V
High (Alarms #2072, 2172) -- the device automatically turns off these alarm limits
T
in NPPV mode.
4. V
Low (Alarms #2073, 2173) -- the device automatically turns off these alarm limits
T
in NPPV mode.
5. Low SpO2 (Alarm #2410)
6. High Heart Rate (Alarm #2410)
7. Low Heart Rate (Alarm #2411)
If an alarm has been turned off and is then modified, but is not accepted, then the alarm
parameter is set to the values indicated in the following table. This is done to ensure patient
safety in the event of an inadvertent value change. You can change these values following the
parameter change procedures described above.
High
Breath
PIP Low
VT High VT Low
Low SpO2
Rate
99 BPM 3 cm H2O 2000 ml 0 ml 86% 240 BPM 30 BPM
High
Heart Rate
Low Heart
Rate
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Alarm Cancellation in Alarm Configuration Menu
There are clinical situations where an alarm occurs, and in the operator’s clinical judgment, this
alarm should be canceled for the remainder of the device’s operating session. The following
constraints apply to alarm cancellation:
• Alarms that have occurred in the current operating session can be canceled.
• Alarms which have not occurred since turn on are indicated with a “--”.
• Canceled alarms are not be saved in the User Settings for the next session.
• All canceled alarms reappear (if appropriate) when the device is next turned on. (As an
example, the Self Check Fault, calibration due Alarm # 3120, reappears in the next
operating session.)
You may cancel the following alarms in the Alarm Configuration Menu:
• PEEP Leak (#2090)
• Annual Check Due (#3120)
• RTC B att Low (#3110)
• Inspiratory Dmnd (#3092)
• Gas Intake Fault (# 3031)
Note: To avoid nuisance alarms, the Auto-PEEP alarm (#3091) is disabled at start up.
The user can choose to activate the alarm if they believe the patient is at risk of AutoPEEP.
Using the ZOLL Ventilator
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Page 87
This chapter provides a detailed description and comprehensive reference for the ZOLL
Ventilator’s alarms and pop up messages. This chapter
• Describes the display format of ZOLL’s Smart Help messages in detail.
• Describes alarm types and priorities.
• Provides a comprehensive list of alarms and pop up messages.
Alarm Overview
To safeguard the patient, the ZOLL Ventilator continuously monitors the patient, device, and
environment to ensure that all of the systems are functioning as intended. When device detects
a problem, it triggers an alarm and displays a Smart Help message to alert you.
On the Smart Help message, a multi-line message screen appears in the upper left-hand corner
of the display screen. This screen area is the Alarm Message Center (AMC). The AMC displays
the alarm name with a series of messages to help you resolve the alarm. The device prioritizes
alarms based on the risk to the patient and always presents the alarm with the greatest risk to the
patient first. All messages are context-based and suggest what is causing the alarm and how it
can be resolved.
Chapter 5
Alarms
The Alarm Message Center (AMC) contains the information and instructions for all active
alarms, as in the following example:
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Alarms
Smart Help Alarm Display
A. Alarm Name: describes the type or cause of the alarm. The Alarm Name appears
at the top of the AMC. When more than one alarm occurs at the same time, the
device prioritizes the alarms based on the highest risk to the patient.
B. Mitigation/Resolution Instructions: prioritized instructions that describe how to resolve
the alarm state.
C. If not Resolved Instructions: Instructions on what to do you cannot resolve the alarm state.
The instruction is always shown in the following format **Message...**.
D. Alarm Icons: For each active alarm, an alarm bell appears. When multiple alarms are
active, the number of bells corresponds to the number of alarms. The alarm in the AMC is
displayed as the solid bell. To view each active alarm, turn the Dial to scroll through all
active alarms. The plot icon is also in this list. It allows you to see the current waveform to
better assess the nature of the failure. A maximum of six alarms can be displayed without
the plot icon.
E. Service Code: Each alarm has a 4 digit number associated with it, which helps the operator
indicate the specific alarm when communicating with technical support. The service codes
appear in the following format:
1### High Priority Alarm
2### Medium Priority Alarm
3### High Priority Alarm
F. Attention Warning Icon: Identifies the severity of the alarm: Low, Medium, or High
priority. See the Symbols table in Chapter 1 for the appearance of the warning triangle for
each of these three alarms.
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Alarm Priorities
Alarm priorities define the operational status of the device and its ability to provide mechanical
ventilation. The alarm priorities are as follows:
High Priority
Mechanical ventilation under user control is no longer possible. This alarm priority requires
immediate intervention. 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 button has no effect on a 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 or fault with the patient, ventilator circuit, a pneumatic subsystem, or pulse oximeter.
This alarm priority requires immediate intervention by the user.
Pressing the Mute button mutes medium priority alarms for 30 seconds. If the alarm trigger still
exists after 3 seconds, the audible alarm recurs until you mute it again for another 30 second
period or the alarm is resolved.
Alarms
Low Priority (Advisory)
Safe mechanical ventilation is active but, there is a fault that you must be aware of to ensure
safe management of the patient or ventilator. Low priority alarms present with both an audible
and yellow LED alarm signal alerting you to the condition. Pressing the Mute button cancels
the audible signal. If the alarm is not resolved, the yellow LED remains illuminated to remind
you of the fault or failure.
Note: Some Low Priority alarms are canceled and the Alarm LED turns green when you
push the Mute button. For others, the audible alarm is canceled but the Alarm LED
stays yellow to remind you that the device is operating in a state that needs monitoring.
Pop Up Messages
These alerts appear whenever you attempt to adjust that device in a way that is outside clinical
norms or is outside the performance range of the ventilator. Pop up messages also appear when
you are required to confirm their action before you proceed.For example, if you try to set the
low breath rate alarm below 4 that would, practically, disable the alarm. If the desired value is
outside the performance range, the pop up message alerts you to why you cannot make the
change. (Example: trying to set the PEEP level greater than the PIP setting).
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Alarms
Muting Alarms
Under most conditions, pressing the Mute button mutes the audible alarm for 30 seconds. As
describe in the previous section, pressing the Mute button when a high priority alarm is active
does not. Using the ZOLL Ventilator, muting functions as follows:
Preemptive Mute -- to prevent excessive noise in the patient care environment patient, safety
alarms, such as Patient Disconnect, PEEP Leak, and so on, can be preemptively muted for 30
seconds. This enables you to prevent the audible alarm, by pressing the Mute button, before
initiating a procedure that could trigger an alarm.
2-Minute Startup Mute -- at start up, the ventilator suspends active patient safety alarms, with
the exception of those alarms that could affect the performance of the device. This prevents
nuisance alarms during start up while you configure the ventilator. When the Start Menu is
used, the 2-minute countdown starts once you select a start option. Once the patient connected,
the mute cancels automatically after 15 seconds when there are no active alarms.
Use in High Noise Environments -- in high noise environments, you may be inclined not to
mute the alarm while addressing the problem. Not pressing Mute limits the user's ability to
resolve the alarm because with each breath the alarm is retriggered and any parameter changes
you are attempting are canceled as the alarm retriggers
Alarms Types
The ZOLL Ventilator’s alarm types provide a framework for you to see the scope and range of
the alarms that the device uses. The alarm types are:
• Patient Safety -- Patient Safety Alarms address the ventilation of the patient and their
respiratory effort. Pulse oximetry monitoring and circuit/exhalation valve issues are also
part of this group.
• Environment - Environment Alarms address the device inputs: external power, battery,
high pressure O2 supply, and the fresh gas intake. Ambient and device temperature,
barometric pressure, and altitude are also part of this group.
• Self Check -- Self Check Alarms address the performance of the device systems and
include
• Internal Communication (Comm): faults/failures of interdevice communication,
cyclic redundancy checking, or processor-related issues
• Pneumatic Sensor: faults/failures of the pneumotachographs that measure gas flow
or the pressure transducers.
• Pneumatic System: faults/failures of the compressor of O
supply proportional
2
valve.
• Power System: faults/failures of the power system that render the device unable to
operate from external power or charge/operate from the internal rechargeable
battery.
• Pulse Oximeter (Ox) Module: faults/failures of the pulse oximeter module that are
not related to monitoring of the patient, a fault or failure of the module.
• Preventive Maintenance: alarms that occur when device is due for preventive
maintenance.
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Alarm Groups
The following table displays the ZOLL Ventilator’s Alarm Groups:
Patient Safety Environment Self-Check
Alarms
Alarm Groups
Airway Pressure
-- High/Low
Apnea External Power
AutoPEEP Gas Intake
Breath Rate (BPM)
-- High/Low
Battery
-- Battery Drained
-- Battery Nearly Drained
-- Battery Low
-- Discharge Fault
-- Too Hot/Cold
-- Current High
-- DC Power Reversed
-- High
-- Low/Disconnect
-- Blocked
-- Restricted
O
Supply
2
-- High/Low - Disconnect
Ambient Pressure
-- High/Low
Firmware Mismatch
Internal Comm
-- Fault/Failures
Pneumatic Sensor
-- Airway
-- Autocal
-- Pneumotach
-- Transducer
Exhalation
-- Fault/Failure
Heart Rate (HR)
-- High/Low
Inspiratory Demand Preventive Maintenance
Insufficient Flow Pulse Oximeter
Pneumatic System
-- Compressor
-- O
Valve
2
Power Cycle Needed
-- Comm Failure
-- Module Failure
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Alarms
Alarm Groups
Patient Safety Environment Self-Check
Patient Detected Temperature
-- High/Low
-- Sensor Failure
PEEP Leak
SpO2
-- Low
-- Disconnect
-- Defective Sensor
-- Not Connected
-- Invalid Sensor
-- Light Contamination
-- Low Perfusion
-- Search
Tidal Volume
-- High/Low
Tubing Compliance
High Priority Alarms
Service Code Alarm Name/Mitigation/Resolution
1001 Self Check Failure
Alarm triggers when the compressor fails to operate or fails to provide the flow
required to deliver a breath and high pressure O
ventilation.
Mitigation/Info: Pneumatic System: Compressor, Manually Ventilate Patient,
Connect 55 psig/380 kPa O
Center**
1002 Self Check Failure
Alarm triggers when communication between the compressor controller and
Smart Pneumatic Module (SPM) is lost and high pressure O2 is not available to
provide ventilation.
Mitigation/Info: Pneumatic System: Compressor, Manually Ventilate Patient,
Connect 55 psig/380 kPa O
Center**
is not available to provide
2
, Restart Ventilator with O2, **Contact Service
2
, Restart Ventilator with O2, **Contact Service
2
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Service Code Alarm Name/Mitigation/Resolution
1003 Self Check Failure
Alarm triggers when the flow from the first breath is ± 20% of the expected flow
for the tidal volume at start up. This unusually low RPM is a symptom of a dirty
flow screen which cannot be serviced by the user.
Mitigation/Info: Pneumatic Sensor: Pneumotach, Manually Ventilate Patient,
**Contact Service Center**
1010 Self Check Failure
Alarm triggers when the O
valve fails in the open position which results in
2
continuous inspiratory flow. When this occurs the device automatically opens the
exhalation valve to prevent pressure from accumulating in the circuit and
ventilation stops.
Mitigation/Info: Pneumatic System: O
Valve, Manually Ventilate Patient,
2
**Contact Service Center**
1011 Self Check Failure
Alarm occurs when the signal to the O
valve is not delivering the required flow
2
rate and the compressor is not available to provide ventilation.
Mitigation/Info: Pneumatic System: O
Valve, Manually Ventilate Patient,
2
**Contact Service Center**
Alarms
1012 Self Check Failure
Alarm occurs when the communication between the O
and the compressor is not available to provide ventilation.
Mitigation/Info: Pneumatic System: O
**Contact Service Center**
1020 Low O2 Supply Failure
Alarm occurs when the O2 supply pressure is < 35 psig (241 kPa) and the
compressor is not available to support ventilation. If the O
restored the device should be cycled off then on to reset. By design the device
will not reestablish O
operation unless the supply pressure is ≥ 40 psig (276
2
kPa). If the supply pressure is between 40 and 87 psig (276 to 600 kPa) the user
should check the hose connections for leaks. Occasionally, this alarm can be
caused by a regulator that provides a static pressure within range but is not able
to provide the flow necessary to meet the patient flow demand.
Mitigation/Info: Manually Ventilate Patient, Connect 55 psig/380 kPa O
Check O
Supply for Leaks, Replace Regulator, **Contact Service Center**
2
1030 Gas Intake Failure
Alarm occurs when the Fresh Gas/Emergency Air Inlet is blocked so that the
compressor is not able to deliver flow sufficient for the current settings and high
pressure O2 is not available to support ventilation. The user should clear the
blockage and restart the ventilator. A false alarm can be triggered in very high
vibration environments.
Mitigation/Info: Manually Ventilate Patient, Clear Blocked Intake, Connect 55
psig/380 kPa O
, Restart Ventilator, **Contact Service Center**
2
valve and the SPM fails
2
Valve, Manually Ventilate Patient,
2
source can be
2
, Restart,
2
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Alarms
Service Code Alarm Name/Mitigation/Resolution
1041 High O2 Supply Failure
Alarm triggers when the O2 supply pressure is > 87 psig (600 kPa). Pressures
above 87 psig (600 kPa) can result in a catastrophic failure, harm to the patient
and/or damage to the device. While the patient is manually ventilated the user or
assistant should seek to reduce the O
supply pressure. Sometimes this requires
2
changing the regulator which is not functioning as required. If the pressure
cannot be reduced and a low flow device like a flow meter is available the user
can provide supplemental O
via the optional low flow O2 reservoir. To clear the
2
alarm the device should be turned off and then restarted with supply pressure in
the appropriate range (40 to 87 psig, 276 to 600 kPa) or without the high
pressure O
source connected.
2
Mitigation/Info: Manually Ventilate Patient, Decrease O2 to 55 psig/380 kPa,
Replace Regulator, Connect Low Flow O
, Restart: **Contact Service Center**
2
1051 Self Check Failure
Alarm triggers when the autocal procedure is not able to zero the airway
pressure transducer to ambient pressure. When this occurs, manually ventilate
the patient, replace the ventilator replaced and contact the service center for
additional information. Note: a false alarm can be triggered during operation in
very high vibration environments when the device is not mounted correctly. If this
could be the cause, restart the ventilator and continue operation if no alarms are
triggered.
Mitigation/Info: Pneumatic Sensor: Autocal, Manually Ventilate Patient, **Contact
Service Center**
1052 Self Check Failure
Communication between the airway pressure sensor and SPM is lost. When this
happens, manually ventilate the patient, replace the ventilator and contact the
service center for additional information.
Mitigation/Info: Pneumatic Sensor: Airway Pressure, Manually Ventilate Patient,
**Contact Service Center**
1060 Exhalation System Failure
Alarm occurs when the PIP fails to return to the baseline pressure for 3
consecutive breaths, indicating that the exhalation control valve has failed. When
triggered, the device stops ventilating and attempts to discharge the pressure in
the breathing circuit to atmosphere. This failure may be caused by a significant
blockage of the exhalation valve or an occlusion/kink in the exhalation valve
tube. If possible, the user should replace the breathing circuit and restart the
ventilator. If this does not resolve the failure, replace the ventilator and contact the
service center for additional information.
Mitigation/Info: Patient Can Not Exhale, Manually Ventilate Patient, Check for
Kinked Hose/Tube, Replace Circuit and Restart, **Contact Service Center**
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Service Code Alarm Name/Mitigation/Resolution
1061 Exhalation System Failure
The airway pressure, PIP, is > 40 cm H
Limit is < 35 cm H
O) for > 5 seconds, or when the PIP is > 75 cm H2O for > 1.5
2
O, the PIP High Limit (when PIP High
2
seconds. When this happens, the device stops ventilating and attempts to
discharge the pressure in the breathing circuit to atmosphere. This failure may
be caused by a significant blockage of the exhalation valve or an occlusion/kink
in the exhalation valve tube. If possible, the user should replace the breathing
circuit and restart the ventilator. If this does not resolve the problem, replace the
ventilator and contact the service center for additional information.
Mitigation/Info: Patient Can Not Exhale, Manually Ventilate Patient, Check for
Kinked Hose/Tube, Replace Circuit and Restart, **Contact Service Center**
1172 Self Check Failure
Alarm occurs when the 5 volt power bus fails to provide the required voltage. If
this failure occurs, the user should manually ventilate the patient, replace the
ventilator and contact the service center for additional information.
Mitigation/Info: Pneumatic Sensor: Autocal, Manually Ventilate Patient, **Contact
Service Center**
1173 Self Check Failure
Alarm occurs when communication fails between one of the subcomponents and
the host processor. If this failure occurs, the user should manually ventilate the
patient, replace the ventilator and contact the service center for additional
information.
Mitigation/Info: Internal COMM, Manually Ventilate Patient, Backup Ventilator
Started, **Contact Service Center**
Alarms
1174 Self Check Failure
Alarm occurs when the device is not able to calibrate the one or more
transducers and is no longer able to operate safely. If this failure occurs, the user
should manually ventilate the patient, replace the ventilator and contact the
service center for additional information.
Mitigation/Info: Pneumatic Sensor: Transducer, Manually Ventilate Patient,
Restart Ventilator, **Contact Service Center**
1175 Self Check Failure
Alarm triggers when the internal communication bus and the host are not able to
communicate with the subassemblies. If this failure occurs, the user should
manually ventilate the patient, replace the ventilator and contact the service
center for additional information.
Mitigation/Infor: Internal COMM, Manually Ventilate Patient, **Contact Service
Center**
1176 Self Check Failure
Alarm triggers when the calibration file fails its integrity check. The user should
manually ventilate the patient, replace the ventilator and contact the service
center for additional information.
Mitigation/Info: Internal COMM, Manually Ventilate Patient, **Contact Service
Center**
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Alarms
Service Code Alarm Name/Mitigation/Resolution
1420 Self Check: Complete Power Failure
Alarm triggers when power is lost from both the internal battery and an external
source during operation. When this occurs, the LCD blanks (no power for
operation), the audible alarm pulses rapidly, and the visual alarm flashes rapidly.
This alarm will last approximately two minutes. If the device can be recharged
after the failure and there are no other issues it can be returned to service. If
there are any questions, contact the service center for additional information.
Mitigation/Info: No LCD Display
1430 Drained Battery
Alarm triggers when the internal battery power drops below the amount required
to provide ventilation and external power is not connected. When this occurs
there is enough power to operate the user interface and provide information to
the user. The user should be manually ventilate the patient while an external
source of power is sought. To cancel the alarm and begin operation with external
power the device must be turned off and then back on.
Mitigation/Info: Manually Ventilate Patient, Connect External Power, **Contact
Service Center**
1471 Self Check Failure
Alarm triggers when the device is no longer able to communicate with the User
Interface Module (UIM) and the interface controls. When this occurs ventilation
continues at the current settings or the backup mode settings and the high
priority alarm sounds. The user should manually ventilate the patient, replace the
ventilator and contact the service center for additional information.
Mitigation/Info: Internal COMM, Manually Ventilate Patient, **Contact Service
Center**
1472 Self Check Failure
Alarm triggers when the device is no longer able to communicate with the Smart
Pneumatic Module (SPM). When this occurs ventilation continues at the current
settings or the backup mode settings and the high priority alarm sounds. The
user should manually ventilate the patient, replace the ventilator and contact the
service center for additional information.
Mitigation/Info: Internal COMM, Manually Ventilate Patient, **Contact Service
Center**
1473 Self Check Failure
Alarm triggers when no valid data is sent from the SPM within 1 second. When
this occurs ventilation continues at the current settings or the backup mode
settings and the high priority alarm sounds. The user should manually ventilate
the patient, replace the ventilator and contact the service center for additional
information.
Mitigation/Info: Internal COMM, Manually Ventilate Patient, **Contact Service
Center**
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Service Code Alarm Name/Mitigation/Resolution
1474 Self Check Failure
Alarm triggers when cyclic redundancy checking between the device and SPM
fails. When this occurs ventilation continues at the current setting or the backup
mode settings and the high priority alarm sounds. The user should manually
ventilate the patient, replace the ventilator and contact the service center for
additional information.
Mitigation/Infor: Internal COMM, Manually Ventilate Patient, **Contact Service
Center**
1475 Self Check Failure
Alarm triggers when the device has lost communication with the contrast control
and in most instances the content of the LCD is not visible. When this occurs
ventilation continues at the current settings or the backup mode setting and the
high priority alarm sounds. The user should manually ventilate the patient,
replace the ventilator and contact the service center for additional information.
Mitigation/Info: Internal COMM, Manually Ventilate Patient, Backup Ventilator
Started, **Contact Service Center**
1480 Self Check Failure
Alarm triggers when the device and SPM software loads are not compatible. This
alarm is typically associated with an SPM change where the technician failed to
update the device and SPM to the current software revision. Ventilation is
provided using the backup mode settings. The user should manually ventilate
the patient, replace the ventilator and contact the service center for additional
information.
Mitigation/Info: Firmware Mismatch, Manually Ventilate Patient, Software
Compatibility Failure, **Contact Service Center**
Alarms
Medium Priority Alarms
Service Code Alarm Name/Mitigation/Resolution
2001 Self Check Fault
Alarm triggers when the communication between the compressor and the SPM
fails and high pressure O
continue to sound as a medium priority alarm until the user acknowledges that
ventilation is being provided using O
the priority changes to low priority. While operating in this state the user should
ensure an adequate supply of O
a high priority alarm.
Mitigation/Info: Pneumatic System: Compressor, Operation Switched to O
Supply, Set FIO
is available to provide ventilation. The alarm will
2
by setting the FIO2 to 100%. At this time
2
. Failure to maintain the O2 supply will result in
2
to 100%, Monitor O2 Supply, **Contact Service Center**
2
2
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Alarms
Service Code Alarm Name/Mitigation/Resolution
2002 Self Check Fault
Alarm triggers when the communication between the O
and the compressor is available to provide ventilation. The alarm will continue to
sound as a medium priority alarm until the user acknowledges that ventilation is
being provided using the compressor by setting the FIO
alarm priority changes to low. While operating in this state the user should
monitor the SpO
is available it can be entrained through the Fresh Gas/Emergency Air Intake
O
2
port using the optional O
supply up or down to increase or decrease the amount of O2 delivered to
the O
2
to ensure that adequate oxygenation is maintained. If low flow
2
reservoir. Maintain an acceptable SpO2 by adjusting
2
the patient.
Mitigation/Info: Pneumatic System: Compressor, Operation Switched to O
Supply, Set FIO
to 100%, Monitor O2 Supply, **Contact Service Center**
2
2011 Self Check Fault
Alarm triggers when the signal to the O
valve is outside of the calibration range
2
for the required flow rate and the compressor is available to provide ventilation.
The medium priority alarm will continue until the user acknowledges that
ventilation is being provided using the compressor by setting the FIO
this time the alarm priority changes to low priority. While operating in this state
the user should monitor the SpO
maintained. If low flow O
is available it can be entrained through the Fresh Gas/
2
Emergency Air Intake port using the optional O
to ensure that adequate oxygenation is
2
reservoir. Maintain an
2
acceptable SpO2 by adjusting the O2 supply up or down to increase or decrease
the amount of O
Mitigation: Pneumatic System: O
delivered to the patient.
2
Valve, Operation Switched to Compressor,
2
Connect Low Flow O2, Monitor SpO2, **Contact Service Center**
valve and the SPM fails
2
to 21%. At this time the
2
2
to 21%. At
2
2012 Self Check Fault
Alarm triggers when the communication between the O2 valve and the SPM fails
and the compressor is available to provide ventilation. The alarm will continue to
sound as a medium priority alarm until the user acknowledges that ventilation is
being provided using the compressor by setting the FIO
alarm priority changes to low. While operating in this state the user should
monitor the SpO
is available it can be entrained through the Fresh Gas/Emergency Air Intake
O
2
port using the optional O
supply up or down to increase or decrease the amount of O2 delivered to
the O
2
the patient.
Mitigation/Info: Pneumatic System O
Flow O
, Monitor SpO2 **Contact Service Center**
2
to 21%. At this time the
2
to ensure that adequate oxygenation is maintained. If low flow
2
reservoir. Maintain an acceptable SpO2 by adjusting
2
Valve, Set FIO2 To 21%, Connect Low
2
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Service Code Alarm Name/Mitigation/Resolution
2020 Low O2 Supply Fault
Alarm triggers when the O
supply pressure is < 35 psig (241 kPa) and the
2
compressor is able to support ventilation. When this occurs the device begins
ventilation using the compressor. The alarm will continue to sound as a medium
priority alarm until the user acknowledges that ventilation is being provided using
the compressor by setting the FIO
to 21%. The alarm will cancel completely
2
when the user sets to 21%. NOTE: The device works with or without external O
is connected the device will not continue O2 operation unless the supply
If O
2
pressure is ≥ 40 psig (276 kPa). This is done to prevent continuous cycling
between alarms during the inspiratory phase and no alarm during the expiratory
phases. If low flow O
is available it can be entrained through the Fresh Gas/
2
Emergency Air Intake port using the optional O2 reservoir. Maintain an
acceptable SpO
the amount of O
by adjusting the O2 supply up or down to increase or decrease
2
delivered to the patient.
2
Mitigation/Info: Operation Switched to Compressor, Check O2 Supply Pressure,
Check/Replace Regulator, Set FIO
, **Contact Service Center**
SpO
2
to 21%. Connect Low Flow O2, Monitor
2
2030 Gas Intake Fault
Alarm triggers when the Fresh Gas/Emergency Air Inlet is blocked so that the
compressor is not able to deliver a breath within ±10% of the current settings and
high pressure O2 is available to support ventilation. When this occurs the
ventilator immediately switches to O
powered ventilation. To clear the alarm first
2
set the FIO2 to 100% to acknowledge that the patient is being ventilated at
100%, clear the blockage and then set the FIO
back to the original value. Once
2
the blockage has been cleared operation with the compressor will restart. If the
blockage cannot be cleared, the alarm will resound, continue ventilation with
set to 100% and ensure an adequate supply of O2. NOTE: A high vibration
FIO
2
environment can trigger this alarm. If necessary, the user can activate the O
Reservoir Mode while continuing to operate normally. This will suppress the
alarm.
Mitigation/Info: Operation Switched to O
to 100%, Monitor SpO
, Monitor O2, **Contact Service Center**
2
Supply, Clear Blocked Intake, Set FIO2
2
Alarms
.
2
2
2053 Self Check Fault
Alarm triggers when the expiratory time is < 170 ms for 3 consecutive breaths.
When this occurs the device attempts to reestablish a baseline by momentarily
setting PEEP to 0 cm H
O and suspending triggered breaths. This interruption
2
lasts no longer than 2 breath cycles. The user should also check for leaks in the
hose and tubes, patient airway and exhalation valve. If recalibration is successful
the alarm will automatically cancel. If the device does not reset, manually
ventilated the patient, replace the ventilator and contact the service center for
additional information.
Mitigation/Info: Pneumatic Sensor: Airway Pressure, Check Circuit for Leaks/
Disconnects, , Check Tube Placement/Cuff, **Contact Service Center**
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Alarms
Service Code Alarm Name/Mitigation/Resolution
2062 Exhalation System Fault
Alarm triggers when the airway pressure, PIP, measured at the end of expiration
is > 5 cm H2O above the baseline pressure, PEEP. This is typically caused by a
restriction of the exhalation valve or an occlusion/kink in one or more of the
breathing circuit tubes or hose. If the breathing circuit tubes appear to be intact
the circuit should be replaced to eliminate the possibility of a bad exhalation
valve. If the condition does not resolve the user should manually ventilate the
patient, replace the ventilator and contact the service center for additional
information.
Mitigation/Info: Check Patient Exhalation, Check Circuit for Kinked Hose/Tube,
Check for Blocked Exhalation Valve, Replace Circuit, Replace/Service Ventilator,
**Manually Ventilate Patient**
2070 Airway Pressure High
Alarm triggers when the airway pressure, PIP, is > the high airway pressure limit
for 2 consecutive breaths. When the limit is reached, the flow decelerates to
keep the PIP below the airway pressure for the duration of the breath (inspiratory
time). The user should check for kinks or blockage of the breathing circuit,
exhalation valve or patient airway. In some instances the cause can be an
accumulation of secretions in the airway which will require suctioning to clear.
The user should also assess if the patient is fighting the ventilator, asynchrony, or
if the high airway pressure limit is set too low.
Mitigation/Info: Pressure Exceeds Limit Setting, Check Circuit for Kinked Hose/
Tube, Check for Airway Obstruction, Suction Airway if Necessary, Check High
PIP Limit Setting, ** Manually Ventilate Patient**
2071 Low Airway Pressure
Alarm triggers when the airway pressure, PIP, is < the low airway pressure limit
for 2 consecutive breaths. The user should check for leaks/disconnects in the
breathing circuit, patient airway or a failure of the exhalation valve. The user
should also assess if the patient is breathing with the ventilator, the PIP or tidal
volume are set too low, or if the low airway pressure limit is set too high. If a
replacement is available the user should replace the breathing circuit. If these
mitigations do not resolve the alarm condition, replace the ventilator and contact
the service center for more information.
Mitigation/Info: Check Patient Connection, Check Circuit For Loose Hose/Tube,
Check Exhalation Valve, Check Tube Placement/Cuff, Check Low Limit Setting,
**Manually Ventilate Patient**
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