Zoll Ventilators Guide

Portable Critical Care Ventilator
Operator’s Guide
Models: EMV+, AEV, Eagle II
731 Series
906-0731-01 Rev. M
The issue date for the ZOLL Portable Critical Care Ventilator Operator’s Guide (REF 906-0731-01 Rev. M)
is May 2024.
Copyright © 2024 ZOLL Medical Corporation. All rights reserved. ZOLL, AEV, EMV+, Eagle II and
Smart Help are registered trademarks or trademarks of ZOLL Medical Corporation in the United States and/or
other countries. All other trademarks are the property of their respective owners.
ZOLL Patent Information
Information about ZOLL patents is available online at www.zoll.com/patents.
Masimo Pulse Oximeter
This device uses Masimo SET® technology to provide continuous pulse oximeter and heart rate monitoring.
Information about Masimo patents is available online 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.
ZOLL Medical Corporation
269 Mill Road
Chelmsford, MA USA
01824-4105
ZOLL International Holding B.V.
Einsteinweg 8A
6662 PW Elst
Netherlands
0123
Table of Contents
List of Figures
Chapter 1
General Information
Product Description ............................................................................................................ 1-1
How to Use this Manual ...................................................................................................... 1-1
Operator’s Guide Updates .................................................................................................. 1-1
Unpacking........................................................................................................................... 1-2
Assembly ............................................................................................................................ 1-2
Symbols used on the Equipment ........................................................................................ 1-2
Conventions ........................................................................................................................ 1-5
Abbreviations ...................................................................................................................... 1-6
Indications of Use ............................................................................................................... 1-7
Features ...................................................................................................................... 1-7
Warnings............................................................................................................................. 1-8
General ....................................................................................................................... 1-8
Pulse Oximeter ......................................................................................................... 1-10
Cautions .................................................................................................................... 1-11
FDA Tracking Requirements ............................................................................................. 1-12
Notification of Adverse Events .......................................................................................... 1-13
Software License .............................................................................................................. 1-13
Limited Warranty ....................................................................................................... 1-14
Service.............................................................................................................................. 1-15
Chapter 2
Product Overview
ZOLL Ventilator Models ...................................................................................................... 2-1
Common Features ...................................................................................................... 2-1
EMV+ .......................................................................................................................... 2-2
AEV ............................................................................................................................. 2-2
Eagle II ........................................................................................................................ 2-3
MRI Variants (Eagle II MRI and EMV+ MRI) .............................................................. 2-3
Ventilator Controls and Indicators ....................................................................................... 2-4
ZOLL Ventilator Features ........................................................................................... 2-5
Pneumatic Diagram ............................................................................................................ 2-6
Connector Panel ................................................................................................................. 2-7
Controls and Indicators ....................................................................................................... 2-8
Display Screen .......................................................................................................... 2-17
Pop Up messages .................................................................................................... 2-20
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TABLE OF CONTENTS
Set-up................................................................................................................................2-23
External Gas Sources ...............................................................................................2-24
Ventilator Circuits: Connections ................................................................................2-26
Ventilator Circuits: Patient Connections ....................................................................2-27
Ventilator Circuits: Resistance, Compliance, and Deadspace ..................................2-28
Operating Power Selection and Stopping .................................................................2-29
Power Supply Connections .......................................................................................2-30
Self-Check ................................................................................................................2-31
Transducer Calibration (AUTO CAL) ........................................................................2-31
Pulse Oximeter Principles .................................................................................................2-32
Chapter 3
Operation
Overview .............................................................................................................................3-1
Introduction .................................................................................................................3-1
Pulse Oximeter ...........................................................................................................3-2
Operation ............................................................................................................................3-3
Modes of Operation ....................................................................................................3-3
Additional Adjuncts of Operation .................................................................................3-4
Spontaneous/Assisted Breath Trigger ........................................................................3-6
To Begin Ventilating ....................................................................................................3-7
To Change Settings ....................................................................................................3-8
Back Up Ventilator ......................................................................................................3-9
Pulse Oximeter ...........................................................................................................3-9
Humidification .............................................................................................................3-9
Hazardous Environment Filters......................................................................................... 3-11
Bacterial/Viral Filter Use ...........................................................................................3-11
Chemical/Biological Filter Use ..................................................................................3-12
Check Valve on Breathing Circuit when in Hazardous Environments ......................3-12
Harsh Environment Operation...........................................................................................3-13
Airborne Particulates .................................................................................................3-13
Extreme Temperature Environments ........................................................................3-13
Altitude ......................................................................................................................3-14
Rain and Snow ..........................................................................................................3-14
Use of Low Flow Oxygen ..................................................................................................3-15
Use In an MRI Environment ..............................................................................................3-18
Chapter 4
Alarms
Smart Help Messages.........................................................................................................4-2
Alarm Priorities ............................................................................................................4-3
Ventilator Alarm Categories.................................................................................................4-4
731 Series Ventilator Alarms ...............................................................................................4-9
Patient Alarms .............................................................................................................4-9
Device Alarms ...........................................................................................................4-11
Environmental Alarms ...............................................................................................4-22
Alarm Turn Off and Cancellation .......................................................................................4-25
Alarm Turn Off at Extreme Range Limits ..................................................................4-26
Alarm Cancellation in Alarm Configuration Menu .....................................................4-27
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Chapter 5
Maintenance
Calibration Checks.............................................................................................................. 5-1
General Cleaning................................................................................................................ 5-2
Preventative Maintenance .................................................................................................. 5-2
Removable Foam Filter Replacement ................................................................................ 5-2
Fresh Gas/Emergency Air Intake Disk Filter Replacement................................................. 5-3
Internal Filter Change/Insertion .......................................................................................... 5-4
Post-Contaminated Environment Cleaning......................................................................... 5-6
Battery Maintenance ........................................................................................................... 5-7
Battery Capacity ......................................................................................................... 5-7
Battery Care and Charging ......................................................................................... 5-7
Internal Battery Change/Insertion ............................................................................... 5-9
Recharging Guidelines ............................................................................................. 5-10
Troubleshooting ................................................................................................................ 5-11
Operator Correctable Problems ........................................................................................ 5-11
Operating Problems Requiring Service ............................................................................ 5-11
Storage ............................................................................................................................. 5-11
Appendix A
Specifications
General ...............................................................................................................................A-1
Pulse Oximeter ...................................................................................................................A-3
IEC 60601-1........................................................................................................................A-4
Appendix B Accessories
Index
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List of Figures
EMV+ Ventilator ........................................................................................................................ 2-2
AEV Ventilator ........................................................................................................................... 2-2
Eagle II Ventilator ...................................................................................................................... 2-3
Eagle II MRI Ventilator .............................................................................................................. 2-3
ZOLL Ventilator Features .......................................................................................................... 2-4
Pneumatic Diagram .................................................................................................................. 2-6
Connector Panel ....................................................................................................................... 2-7
Example: Outlined/Normal Text ................................................................................................ 2-8
Controls ..................................................................................................................................... 2-9
Display Screen ........................................................................................................................ 2-17
Pop Up Message Example ..................................................................................................... 2-20
External Gas Sources ............................................................................................................. 2-24
Fresh Gas/Emergency Air Intake ............................................................................................ 2-25
Ventilator Circuit Device Connections ..................................................................................... 2-26
Ventilator Circuit, Patient Connections ................................................................................... 2-27
Connecting and Disconnecting the Power Supply .................................................................. 2-30
Power Supply Latching ........................................................................................................... 2-30
Pulse Oximeter Discrete Saturation Transformation ............................................................... 2-33
Hazardous Environment Filters ............................................................................................... 3-11
Check Valve Connection To Breathing Circuit ........................................................................ 3-12
Oxygen Reservoir Bag Assembly ........................................................................................... 3-17
ZOLL Ventilator Mounted On MRI Rolling Stand With IV Support Arm .................................. 3-19
MR Labels on ZOLL Ventilator ................................................................................................ 3-20
Smart Help Example ................................................................................................................. 4-1
Smart Help Display ................................................................................................................... 4-2
ZOLL Ventilator Storage Case ................................................................................................ 5-10
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Chapter 1
General Information
Product Description
The ZOLL® Portable Critical Care 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.
How to Use this Manual
The ZOLL Portable Critical Care 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 unit care are located in Chapter 5, “Maintenance”.
Operator’s Guide Updates
An issue or revision date for this manual is shown on the front cover.
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 web site at www.zoll.com.
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CHAPTER 1 GENERAL INFORMATION
Unpacking
Carefully inspect each container for damage. If the shipping container or cushion material is
damaged, keep it until the contents have been checked for completeness and the instrument has
been checked for mechanical and electrical integrity. If the contents are incomplete, if there is
mechanical damage, or if the ventilator does not pass its electrical self-test, U.S.A. customers
should call ZOLL Medical Corporation (1-973-882-1212). Customers outside of the U.S.A.
should contact the nearest ZOLL authorized representative. If the shipping container is
damaged, also notify the carrier. If there is no apparent sign of mechanical damage, read
instructions contained within this manual before attempting operation.
Assembly
The unit only requires that the operator attach the breathing circuit to begin ventilation using
either internal or external power. Both the ventilator and breathing circuit are supplied clean
and are ready for use on a patient.
The unit’s batteries may not be installed within the unit (depending on the contractual
requirements or the storage environment as described in the “Battery Care and Charging”
section). Battery installation may be required prior to operation.
Symbols used on the Equipment
Any or all of the following symbols may be used in this manual or on this equipment.
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.
Accept / Confirm: Identifies button which accepts the parameter
selection.
ESD: Warns that connector pins should not be touched.
Defibrillation Proof: Indicates the degree of protection against electrical
shock.
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Symbols used on the Equipment
Symbol
Description
Alarm Bell: Identifies the number of off-screen alarms
Alarm Bell Outline: Identifies alarm limit settings; Identifies the on-screen
alarms.
Attention: High Priority Alarm Active.
Caution: Medium Priority Alarm Active.
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 unit is operating using an external power
source.
No External Power: Indicates the unit is operating without an external
power source.
Internal Battery: Provides indication of battery capacity and charging.
No Internal Battery: Indicates when internal battery is not an available
power source.
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CHAPTER 1 GENERAL INFORMATION
Symbol
Description
Heart: Provides indication that the pulse oximeter is in use.
Rotary Encoder: Identifies the ROTARY ENCODER which allows
adjustment of a selected parameter value.
Do Not Re-Use: This item should not be re-used.
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.
BF Symbol: Protection against electric shock, Type B with floating
(F-type) parts.
Head w/ Mask: The unit is in Non-invasive Positive Pressure Ventilation
(NPPV) mode.
MR Symbol: Identifies the use of the device’s ability to perform in a MRI
environment.
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.
Consult Instruction: Consult the instructions for use or operation manual.
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Conventions
Conventions
This guide uses the following conventions:
Within text, the names and labels for physical buttons and softkeys appear in boldface type (for
example, “Press the CONFIRM/SELECT button”).
This guide uses uppercase italics for text messages displayed on the screen
(for example, LEAD FAULT).
Warning!
Warning statements alert you to conditions or actions that can result in personal injury
or death.
Caution
Caution statements alert you to conditions or actions that can result in damage to the unit.
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CHAPTER 1 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
ATLS- 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
ATPD - Atmospheric Temperature and Pressure Dry
MRI- Magnetic Resonance Imaging
b/min- Beats Per Minute
NPPV – Noninvasive Positive Pressure Ventilation
B/V - Bacterial/Viral Filter
O2- oxygen
BiPAP- Bilevel positive airway pressure
Paw - Airway Pressure
BPM - Breaths per Minute
PEEP - Positive End Expiratory Pressure
cm H2O - Centimeters of Water
PIP - Peak Inspiratory Pressure
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
Ventilation
ESD- Electrostatic Discharge
SPM- Smart Pneumatic Module
FIO2 - Fraction of Inspired Oxygen
USP - United States Pharmacopeia
HME - Heat and Moisture Exchanger
VAC - Volts AC
HMEF - Heat and Moisture Exchanger/Bacterial Viral
filter combined
VDC - Volts DC
HP O2- High Pressure Oxygen
VT - Tidal Volume
Hz – Hertz (as in frequency, cycles per second)
WOB – Work Of Breathing
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Indications of Use
Indications of Use
The devices in the ZOLL ventilator are indicated for use in the management of infant through
adult patients weighing ≥ 5 kg with acute or chronic respiratory failure or during resuscitation
by providing continuous positive-pressure ventilation. They 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, they are suitable
for use in an MRI environment with appropriate precautions. The 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. The EMV+® and Eagle II™
(with and without MRI label) have a full range of ventilation modes (AC, SIMV with or
without PS, CPAP with or without PS with PPC or NPPV-PPV). The AEV® provides specific
modes consistent with pre-hospital care provider’s operating procedures (AC, CPAP with PS
and NPPV-PPV).
The ZOLL ventilators are 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 (ALS, ATLS, ACLS), field hospitals, and hospital settings. Easy-to-use,
durable, lightweight, and portable, the ZOLL ventilators are built with the same standard of
quality, reliability, and performance for which all ZOLL products are known.
Features
• Portable critical care ventilator that can be used in the hospital, aeromedical and ground
transport, mass casualty situations, and extreme environments.
• Multiple modes of ventilation for use with acute or chronic respiratory failure in both
intubated and non-intubated patients.
• Intuitive operator interface minimizes operator training and protects existing settings from
inadvertent contact and manipulation.
• Lightweight (~9.7 lbs, ~4.4 kg) provides for easy transport.
• Rechargable battery provides over 10 hours of operation (at factory default with pulse
oximeter operating).
• Operating temperature range from -25 to 49°C (ZOLL validated testing) and from 10°C to
40°C (SGS listed).
• Altitude compensation from -2,000 to 25,000 ft.
• Self-contained system able to operate with or without external oxygen.
• Gas manifold design allows operation with both high and low-pressure oxygen sources. All
oxygen is delivered to the patient breathing circuit.
• Sealed gas path with chemical/biological filter connected to assure safe breathing gas
supply.
• Sealed case and control panel protects components from weather and fluids.
• Smart Help messages guide the operator through on-screen commands when responding to
alarms.
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CHAPTER 1 GENERAL INFORMATION
Warnings
General
• Electric shock hazard: Do not remove equipment covers except to replace the batteries. An
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operator may only perform maintenance procedures specifically described in this manual.
Refer servicing to ZOLL® or an authorized ZOLL® Service Center in the repair of this
equipment.
The device is intended for use by qualified personnel only. The operator should read this
manual, all precautionary information, and specifications before using the device.
Possible explosion hazard if used in the presence of flammable anesthetics or other
flammable substances in combination with air, oxygen-enriched environments, or nitrous
oxide.
During operation, the unit should not be stacked on top of or under other medical equipment
due to the possibility of electromagnetic interference between the unit and other equipment.
Before using on a patient, the operator should observe the device in its normal configuration
to assure that EMC interference between equipment is not occurring. (The unit was
subjected to EMC testing in accordance with Military Mil-STD-461F, Commercial IEC
60601-1-2, and FDA Reviewers Guidance specification.)
The equipment set up should not prevent this device from being disconnected from the
mains power in an emergency.
The use of accessories and cables other than those specified, with the exception of
accessories and cables sold by ZOLL as replacement parts for internal components, may
result in increased emissions or decreased immunity of this device.
Note: The operator should be aware that this device needs special precautions regarding
EMC and needs to be installed and put into service according to the EMC
information provided in this document.
The operator should be aware that portable and mobile RF communication equipment may
affect the performance of this device. The EMC test specifications for this device are
located in the Specifications section of this operator’s guide.
This equipment/system may cause radio interference or may disrupt the operation of nearby
equipment. It may be necessary to take mitigation measures, such as re-orienting or
relocating of the device or shielding the location.
The protection against defibrillation depends on the use of accessories (including pulse
oximeter) that are specified by ZOLL.
Grounding:
• Connect the unit only to a three-wire, grounded, hospital-grade receptacle. The
three-conductor plug must be inserted into a properly wired three-wire receptacle;
if a three-wire receptacle is not available, a qualified electrician must install one in
accordance with the governing electrical code.
• Do not under any circumstances remove the grounding conductor from the power
plug.
• Do not use extension cords or adapters of any type. The power cord and plug must
be intact and undamaged.
• If there is any doubt about the integrity of the protective earth conductor
arrangement, operate the oximeter on internal battery power until the AC power
supply protective cover is fully functional.
To ensure patient electrical isolation, connect only to other equipment with electronically
isolated circuits.
Do not use anti-static or conductive hoses or tubing with this device.
Do not connect to an electrical outlet controlled by a wall switch or dimmer.
As with all medical equipment, carefully route the ventilator circuit hose and tubing, patient
cabling, and external power cables to reduce the possibility of patient entanglement or
strangulation.
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Warnings
• Do not place the unit or external power supply in any position that might cause it to fall on
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the patient. Do not lift the unit by the power supply cord, ventilator circuit, or pulse
oximeter patient cable.
Do not use the unit during magnetic resonance imaging (MRI) scanning unless it has the
appropriate “MRI conditional” label. See “Use in an MRI Environment” for instructions on
the use of MRI conditional units, which details additional Warnings and Cautions.
The unit must be connected to a grounded AC power supply when connected to AC power.
The unit and its ZOLL-supplied integrated pulse oximeter are referred to as an IEC 601/F
device in the summary situation table contained in IEC-601-1-1.
USB Interconnection: Do not operate the device on a patient when the USB is connected to
any other device.
Note: The USB interconnection does not support automatic record keeping.
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. humidification, filters etc.), the operator should assure they do not degrade the
performance of the device. If non-ZOLL circuits are used, the operator should assure these
circuits do not affect the performance of the device.
This device has altitude compensation between -2000 to 25,000 ft (-610 to 7620 m). If
operating outside this range, an Excessive Altitude (3131) alarm will sound. Compensation
for altitude and the performance of the device outside of this range must be managed by the
operator under the direction of a physician.
This device has been tested to perform in humidity levels as specified in MIL-STD-810F.
Use outside the specified range is not recommended for extended periods.
Do not modify this equipment without authorization of the manufacturer.
Disconnect electrical power supply before servicing.
Never service the ventilator while in use with a patient.
Pins of connectors identified with the ESD warning symbol should not be touched and
connections should be made to these connectors unless ESD precautionary procedures are
used.
Note: Staff must be made aware that accessible pins of connectors identified with the
ESD warning symbol should not be touched with the fingers or with a hand-held
tool unless proper precautionary procedures have been followed.
Precautionary procedures include:
• Methods to prevent build-up of electrostatic charge (e.g. air conditioning,
humidification, conductive floor coverings, non-synthetic clothing).
• Discharging one’s body to the frame of the device or to earth or a large metal
object.
• Bonding oneself by means of a wrist strap to the device or to earth.
Note: Staff that could touch connectors identified with the ESD warning symbol should
receive this explanation and training. This includes clinical/biomedical engineering
and health-care staff.
Note:
ESD training should include an introduction to the physics of electrostatic
discharge, the voltage levels that can occur in normal practice, and the damage that
can be done to electronic components if equipment are touched by an operator who
is electrostatically charged. Further, an explanation should be given of methods to
prevent build-up of electrostatic charge, and how and why to discharge one’s body
to earth or to the frame of the device, or bond oneself by means of a wrist strap to
the device or to earth prior to making a connection.
• 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 batteries.
• This device is not intended for use in explosive atmospheres.
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CHAPTER 1 GENERAL INFORMATION
Pulse Oximeter
• A pulse oximeter should not be used as an apnea monitor.
• A pulse oximeter should be considered an early warning device. As a trend towards patient
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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:
• Incorrect sensor application or use.
• Significant levels of dysfunctional hemoglobin (e.g. carboxyhemoglobin or
methemoglobin).
• Intravascular dyes such as indocyanine green or methylene blue.
• Exposure to excessive illumination, such as surgical lamps (especially ones with a
xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, or
direct sunlight (exposure to excessive illumination can be corrected by covering the
sensor with a dark or opaque material).
• Excessive patient movement.
• Venous pulsations.
• Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter,
or intravascular line.
• The pulse oximeter can be used during defibrillation, but the readings may be
inaccurate for a short time.
Interfering Substances: carboxyhemoglobin may erroneously increase readings. The level of
increase is approximately equal to the amount of carboxyhemoglobin present. Dyes, or any
substance containing dyes, that change usual arterial pigmentation may cause erroneous
readings.
Alarms: Check alarm limits each time the pulse oximeter is used to ensure that they are
appropriate for the patient being monitored.
Loss of pulse signal can occur in any of the following situations:
• The sensor is too tight.
• There is excessive illumination from light sources such as a surgical lamp, a
bilirubin lamp, or sunlight.
• A blood pressure cuff is inflated on the same extremity as the one with an SpO2
sensor attached.
• The patient has hypotension, severe vascoconstriction, severe anemia, or
hypothermia.
• There is arterial occlusion proximal to the sensor.
• The patient is in cardiac arrest or is in shock.
Sensors:
• Before use, carefully read the LNCS® sensor directions for use.
• Use only Masimo oximetry sensors for SpO2 measurements. Other oxygen
transducers (sensors) may cause improper performance.
• Tissue damage can be caused by incorrect application or use of an LNCS® sensor
for example, by wrapping the sensor too tightly. Inspect the sensor site as directed
in the sensor Directions for Use to ensure skin integrity and correct positioning
and adhesion of the sensor.
• Do not damage LNCS® sensors. Do not use an LNCS® sensor with exposed optical
components. Do not immerse the sensor in water, solvents, or cleaning solutions
(The sensors and connectors are not waterproof). Do not sterilize by irradiation,
steam, or ethylene oxide. See the cleaning instructions in the directions for reusable
Masimo LNCS® sensors.
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Warnings
Do not use damaged patient cables. Do not immerse the patient cables in water,
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 or pulse oximetry sensors 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 oximetry
measurements.
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Cautions
• The circuit should be inspected every day to ensure that there is no damage or wear that
could affect its performance. Fluid or other biological material should be removed from the
circuit or the circuit should be replaced following the local standard of care.
• Federal law restricts this device to sale by or on the order of a physician.
• Service is to be performed by qualified biomedical equipment technicians only.
• Internal components are susceptible to damage from static discharge. Do not remove device
covers.
• Possession or purchase of this device does not convey any expressed or implied license to
use the device with unauthorized sensors or cables which would, alone, or in combination
with this device fall within the scope of one or more of the patients related to this device.
ZOLL cannot ensure the proper functioning of this device if it is used with unauthorized
sensors or cables.
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CHAPTER 1 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) 421-0022
Telephone: (973) 882-1212
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Notification of Adverse Events
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.
Software License
Note:
Read this Operator’s Guide and License agreement carefully before operating any of
the ZOLL ventilator products.
Software incorporated into the system is protected by copyright laws and international
copyright treaties as well as other intellectual property laws and treaties. This software is
licensed, not sold. By taking delivery of and using this system, the Purchaser signifies
agreement to and acceptance of the following terms and conditions:
1. Grant of License: In consideration of payment of the software license fee which is part of
the price paid for this product, ZOLL Medical Corporation grants the Purchaser a
nonexclusive license, without right to sublicense, to use the system software in object-code
form only.
2. Ownership of Software/Firmware: Title to, ownership of, and all rights and interests in the
system software and all copies thereof remain at all times vested in the manufacturer, and
Licensors to ZOLL Medical Corporation and they do not pass to purchaser.
3. Assignment: Purchaser agrees not to assign, sublicense, or otherwise transfer or share its
rights under the license without the express written permission of ZOLL Medical
Corporation.
4. Use Restrictions: As the Purchaser, you may physically transfer the products from one
location to another provided that the software/firmware is not copied. You may not disclose,
publish, translate, release, or distribute copies of the software/firmware to others. You may
not modify, adapt, translate, reverse engineer, decompile, crosscompile, disassemble, or
create derivative works based on the software/firmware.
NO IMPLIED LICENSE
Possession or purchase of this device does not convey any express or implied license to use the
device with replacement parts which would, alone, or in combination with this device, fall
within the scope of one or more of the patents relating to this device.
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CHAPTER 1 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
Service
If a unit requires service, contact the ZOLL Technical Service Department.
For customers In the U.S.A.
Telephone:
Fax:
Email:
For customers outside the U.S.A.
1-978-421-9655
Call the nearest authorized ZOLL Medical Corporation
representative.
1-978-421-0010
To locate an authorized service center, contact the
International Sales Department at
[email protected] ZOLL Medical Corporation
27 Fairfield Place, P.O. Box 508
West Caldwell, NJ 07007-0505
Telephone: 1-973-882-1212
When requesting service, please provide the following information to the service
representative:
• Unit serial number
• Description of the problem
• Department using the equipment and name of the person to contact
• Purchase order to allow tracking of loan equipment
• Purchase order for a unit with an expired warranty
Returning a unit for service
Before sending a unit to the ZOLL Technical Service Department for repair, obtain a service
request (SR) number from the service representative.
The Lithium ion battery should remain inside the unit. Follow directions provided on the RGA.
Pack the unit with its cables in the original containers (if available) or equivalent packaging. Be
sure the assigned service request number appears on each package.
For customers
Return the unit to
In the U.S.A.
ZOLL Medical Corporation
27 Fairfield Place, P.O. Box 508
West Caldwell, NJ 07007-0508
Attention: Technical Service Department (SR number)
Telephone: 1-973-882-1212
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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CHAPTER 1 GENERAL INFORMATION
For customers
Return the unit 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
ZOLL Ventilator Models
The ZOLL Critical Care ventilator is designed to manage infant through adult patients with
acute or chronic respiratory failure or during resuscitation by providing continuous
positive-pressure ventilation. (See “Indications of Use”)
The ventilator comes in five models:
•
•
•
•
•
EMV+
EMV+ MRI
Eagle II
Eagle II MRI
AEV
Common Features
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
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Rugged design
Weight: ~10 lbs
10 hour battery life
Rapid charger to achieve 90% battery capacity in 2 hours
Pressure and volume ventilation modes: AC, SIMV with or without PS, CPAP with or
without PS, with and without NPPV/PPV
Pressure support
Leak compensation
High performance internal compressor
PEEP control
Smart Help messages
Masimo SET Measure through Motion
Low-Perfusion Pulse Oximetry
Integral SpO2
Airworthiness Release
Daylight visible display
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CHAPTER 2 PRODUCT OVERVIEW
• Oxygen efficient
• Supports infant, pediatric, and adult patients
• Limited 1 year warranty
EMV+
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 with or
without PS, and CPAP with or without PS with NPPV-PPV.
EMV+ Ventilator
AEV
The AEV ventilator is built for managing ventilator support patients during ambulance
transport. It’s ventilation modes (AC, CPAP with PS and NPPV) are specifically chosen to be
consistent with pre-hospital care provider’s operating procedures.
AEV Ventilator
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ZOLL Ventilator Models
Eagle II
The Eagle II ventilator adapts the ventilation modes for the EMV+ (AC, SIMV with or without
PS, CPAP with or without PS with NPPV-PPV) for use by intensive care units, emergency
departments, and intra-hospital transport. It’s design also allows it to be mounted onto walls or
onto specified boom arms and roll stands as well as gurneys.
Eagle II Ventilator
MRI Variants (Eagle II MRI and EMV+ MRI)
The Eagle II MRI and EMV+ MRI ventilators have been approved for use in MRI suites. These
devices have been successfully tested to 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. The
devices come with two 12 ft. MRI patient circuits and can be mounted on an available MRI
conditional roll stand.
Eagle II MRI Ventilator
Note:
The Pulse Oximeter cannot be used in an MRI environment.
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CHAPTER 2 PRODUCT OVERVIEW
Ventilator Controls and Indicators
The following illustration shows the ZOLL ventilator’s main features:
1.
2.
3.
4.
5.
6.
8.
7.
9.
10.
ZOLL Ventilator Features
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Ventilator Controls and Indicators
ZOLL Ventilator Features
Item
Description
1.
Oxygen Inlet
Connects the unit to an external oxygen source
2.
Status Indicator LED Array
Lights up to indicate status of the unit, connected to alarms
3.
External Power Input Connector
Connects the unit to an external power source
4.
USB Connector
Connects the unit to a USB drive or USB compatible device
5.
Pulse Oximeter Connector
Connects the unit to a Pulse Oximeter sensor
6.
Fresh Gas/Emergency Air Intake
Allows the unit’s internal compressor to take ambient air and acts as an
anti-asphyxia valve
7.
LCD Display
Displays the unit’s settings, patient data, and alarm information
8.
Alarm Message Center
Displays active alarms and mitigation information
9.
Control Panel
Access to the unit settings
10.
Battery Compartment
Contains the unit’s rechargable lithium ion battery
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Pneumatic Diagram
The following image is a diagram of the ZOLL ventilator’s pneumatic design.
Pneumatic Diagram
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Connector Panel
Connector Panel
The ZOLL ventilator Connector Panel appears as follows:
HIGH PRESSURE
OXYGEN INPUT
GAS
OUTPUT
EXTERNAL POWER
INPUT
USB
CONNECTOR
TRANSDUCER
(PATIENT
AIRWAY
PRESSURE)
PULSE
OXIMETER
CONNECTOR
EXHALATION
VALVE
FRESH
GAS/EMERGENCY
AIR INTAKE
Connector Panel
The connector panel for the ZOLL ventilator unit has the following components:
Oxygen Input -- connects the unit to the output of an appropriate oxygen regulator attached to
a medical-grade (USP) oxygen cylinder. The OXYGEN IN fitting has a male oxygen Diameter
Index Safety System (D.I.S.S.) thread. A green (white in some installations), 6 foot long
high-pressure oxygen hose with compatible fittings that provides for connection between the
unit and the oxygen source is required. (Also see “Harsh Environment Operation” section).
Note:
If external oxygen is connected, the gas pressure must be at least 41-psig (± 2 psig)
when SELF-CHECK is performed.
Gas Output -- connects to the ventilator circuit 22 mm ID corrugated hose. The connector is a
22 mm male conical connection.
Fresh Gas/Emergency Air Intake -- allows ambient air into the unit’s internal compressor.
The port also functions as the internal anti-asphyxia valve, which allows the patient to breathe
ambient air in the event of a ventilator failure. The intake contains a particulate filter and
permits the operator to connect either a bacterial/viral or a chemical/biological filter depending
on ambient conditions.
Transducer (Patient Airway Pressure) -- connects to the ventilator circuit 3/16” ID
transducer tubing. The barb-type connector is colored a green/blue to distinguish it from the
other connectors.
Note:
The 3/16” ID ventilator circuit transducer tubing is a green/blue (darker) color.
Exhalation Valve -- connects to the ventilator circuit 1/4” ID exhalation valve tubing.
The barb-type connector is clear anodized aluminum to distinguish it from the other connectors.
Note:
The 1/4” ID ventilator circuit exhalation valve tubing is clear.
External Power Input -- accepts DC voltage between 12.5 and 28 volts (negative ground).
The input mates with the output connector plug of the AC/DC Power Supply, 12 and 28 VDC
Power Cables (both are available as accessories) or the external battery.
USB Connector -- connects the unit to a USB drive or any USB compatible device.
Pulse Oximeter Connector -- connects the unit to a pulse oximeter sensor probe.
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CHAPTER 2 PRODUCT OVERVIEW
Controls and Indicators
The unit contains various controls and indicators that are placed to facilitate ease of use and
visibility in all operating environments. A liquid crystal display (LCD) provides continuous
display of control settings, operating conditions, power, and alarm status information. The
location of each control and indicator is shown in the figure below (their respective location
callouts are listed below). Most unit functions are controlled by pressing the Parameter button
associated with the parameter you wish to change. Pressing the Parameter button highlights the
primary parameter; additional presses highlight secondary parameters moving in a clockwise
direction. When the parameter you wish to change is highlighted, turn the ROTARY
ENCODER clockwise or counter clockwise to adjust the parameter to the desired value and
confirm the new value by pressing the CONFIRM/SELECT button. Once this is done, the
highlight goes away and the unit begins operation using the new parameter. The operator may
cancel any operation and return to the primary operating screen by pressing the
MUTE/CANCEL button. A parameter stays highlighted for 5 seconds; after this time, the unit
automatically cancels the operation and returns to the default screen. Additional functionality
associated with a parameter is viewed in Context Menus which are accessed by pressing and
holding the parameter button for ~1 second. Parameter and their associated Context Menus are
described below.
To assist the operator in recognizing parameters that can be changed and those that are
dependent on the patient, the unit uses “Outlined” text to demonstrate patient dependent values.
Parameters in Outlined text cannot be adjusted. For example, during volume targeted
ventilation the PIP value is displayed as outlined text because it is dependent on the patient’s
resistance and compliance. In pressure targeted ventilation the tidal volume is outlined text.
Example: Outlined/Normal Text
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Controls and Indicators
Controls
The Control Panel incorporates all controls and the LCD display. The controls consist of
buttons, a Power Off/On switch, and a Rotary Encoder that we describe in the following
section. Context Menu controls are shown in tables associated with their parameter button.
1. HR -- Pressing the HR button highlights the High Heart Rate alarm limit and enables its
value to be changed. Pressing the HR button a second time will highlight the current value
of the Low Heart Rate Alarm limit and enable its value to be changed. The HR parameters
are functional only when the pulse oximeter is connected. Both limits are adjustable by
1 b/min. The default value at start up for the high alarm limit is 120 b/min; the low alarm
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CHAPTER 2 PRODUCT OVERVIEW
limit is 40 b/min. To access the HR context menu, press and hold the HR parameter button.
The HR context menu provides control of the pulse oximeter settings.
Masimo Context Menu
Menu Item
Range
Description
Averaging
2-4, 4-6, 8, 10, 12, 14, 16 (t=sec)
Adjusts the SpO2 and HR averaging durations
Sensitivity
Norm, Max
Default: Norm, adjusts the pleth signal
sensitivity. Max is designed to interpret and
display data for even the weakest of signals.
This choice is recommended during procedures
and when clinician and patient contact is
continuous.
Fast SAT
Off, On
Default: Off, 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 SpO2 is paramount
such as induction, intubation, and sleep
studies.
APOD
Off, On
Default: Off, 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.
Signal Strength
0 to 20
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.
Signal IQ
Bar graph
Bar graph displays the relative reliability of the
pulse oximeter signal.
2. SpO2 -- Pressing the SpO2 button highlights the Low SpO2 Alarm Limit and enables its
value to be changed. The SpO2 display is active only when the pulse oximeter is connected.
When no SpO2 sensor is connected or if the probe is off the patient during start up or the
operator places the pulse oximeter in standby (stby) is displayed in the parameter window.
The default low SpO2 value at start up is 94%. SpO2 uses the same Context Menu as HR.
3. FIO2 -- Pressing the FIO2 button highlights the current value and enables it to be changed.
There are no adjustable secondary parameters. The default values at start up is 21% whether
oxygen is present or not. If an FIO2 value greater than 21% is saved and used for Power Up
settings, the unit will start up with that saved FIO2 value if high-pressure oxygen is present.
If high-pressure oxygen is not present, the unit will start up with FIO2 = 21% and O2 SUPPLY
PRESSURE LOW alarm will not be activated. The secondary display in the parameter
window is O2 Use1. This is the flow (liters/min) of high pressure oxygen used by the unit to
support the patient at the current settings. O2 Reservoir mode is indicated on the display with
a plus “+” sign next to the FIO2 value when this mode is active. (The “O2 Use” value does
not include oxygen use in the O2 Reservoir.)
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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Controls and Indicators
4. PIP (Peak Inspiratory Pressure) -- 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.
PIP Context Menu
Menu Item
Range
Description
Pressure Support*
0 to 60
PS value is the pressure over the PEEP setting
*See “Additional Modes of Operation” for additional information on Pressure Support
Note:
PIP values greater than 60 cm H2O require the operator to perform a separate
confirmation.
5. VT (Tidal Volume) -- In volume targeted modes, pressing the VT button highlights the
current set tidal volume and enables it to be changed. In pressure targeted breaths, the
delivered tidal volume is shown as outlined text and is based on the patient pulmonary
mechanics. The VT High and Low Limits are also available as secondary parameters.
Note:
Warning!
In the CPAP-NPPV, the VT delivered and Vmin may be overestimates of the true
volume going to the patient when leaks are present. The O2 Use values will accurately
display the O2 use though the amount used will be more than if no leak was present.
If significant leaks are present during CPAP-NPPV, the VT delivered and Vmin shown
may be overestimates of what is actually being delivered to the patient. The adequacy of
ventilation should be assessed using an alternate method.
6. BPM (Breaths Per Minute) -- Pressing the BPM button highlights the current breathing rate
and enables it to be changed. Secondary parameters include high breath rate, low breath rate,
and I:E ratio, which can be adjusted by pressing the Parameter button the appropriate number
of times. During CPAP operation, the patient’s actual breathing rate is displayed as the BPM
primary parameter in outlined text.
BPM Context Menu
Menu Item
Range
Description
Control Parameter
I:E, TI
Allows operator to select independent variable
Rise Time
1 to 10
Determines the speed of the rise flow: low
values fast rise, high values low rise
Cycle Off%
10 to 70% (default 25%)
Allows operator to adjust Cycle Off%
Control Parameter -- the operator can select which parameter is dependent or independent.
Selecting I:E results in the ventilator maintaining the I:E Ratio while the Inspiratory time
(TI) varies when the breathing rate is changing. Selecting TI maintains a constant
Inspiratory time while the I:E ratio varies when the rate is changed.
Rise Time -- the unit allows the operator to adjust the time it takes to reach the full
respiratory flow and peak Inspiratory pressure during pressure targeted breathing and when
pressure support is being used. The range is 1 to 10 where 1 is the shortest rise time and 10
is the longest rise time. When the unit is turned on, either the default Rise Time or a User
Rise Time will be used. Using the Pressure-Time waveform as reference will assist the
operator in setting the Rise Time.
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CHAPTER 2 PRODUCT OVERVIEW
The Rise Time settings should be reassessed and adjusted after the patient is placed on the
ventilator and initially stabilized. To minimize patient’s work of breathing and potential for
pressure overshoots, operators 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
Rise Time
5
1
20
3
50
5
200
10
An adult patient with high Resistance may benefit from a Rise Time setting of 3 to 4 for
optimal breath delivery. Rise Times of 8-10 are optimized for infants and are flow limited.
(The infant circuit is not intended for flows > 60 LPM.)
Cycle Off% -- the unit allows the operator to adjust the Cycle Off%. The primary purpose
of this parameter is to set a fraction of peak flow at which inspiration ends and exhalation
begins. A key application for Cycle Off% is to adjust for leaks present in and around the
patient circuit or the patient themselves.
Note:
The longest duration of a spontaneous pressure supported breath is limited to 5
seconds. At the end of this time, the ventilator ends flow and opens the exhalation
valve. (All other breaths are time cycled.)
Cycle Off% is principally made available as a parameter for NPPV mode, where a
much higher setting is required to cycle the breath properly in the presence of a
leak. If a higher value is not used and there is a leak, the tendency will be for the
system to time cycle at 5 seconds instead of flow cycle. This is due to the fact that
the leak flow might be higher than 25% of the peak flow, so the cycle threshold is
never crossed.
• If there is no leak, increasing the Cycle Off% will cause breaths to cycle sooner,
thus delivering less volume. If it is set too high, the breath will end early relative to
patient effort and may lead to the triggering of a second breath.
Note: Clinicians must carefully assess the patient’s response to the Cycle Off%
application and must carefully adjust the flow cycle setting to optimize patient
ventilatory support and comfort.
•
7. Mode -- Pressing the MODE button will highlight the current ventilation mode. Pressing the
Parameter button again will allow for the selection of volume or pressure targeting which is
shown as either “(V)” for volume or “(P)” for pressure. Selecting volume assures a constant
volume is delivered to the patient in the inspiratory time using a constant flow. Pressure
targeting ventilation provides a constant airway pressure for the duration of the inspiratory
time using a decelerating flow pattern. See “Additional Modes of Operation” for a
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Controls and Indicators
description of how to enter the NPPV (Noninvasive Positive Pressure) adjunct in the Mode
parameter window. To access the Mode Context menu, press and hold the MODE parameter
button. This will permit the Apnea Back Up settings to be set.
Mode Context Menu
Menu Item
Range
Description
BPM
1 to 60
Allows operator to select BPM for Apnea Back
Up
PIP Target
10 to 80
Allows operator to select the PIP Target for
Apnea Back Up
I:E, TI
1:1 to 1:99, 0.3 to 3
Allows operator to select either I:E or TI for
Apnea Back Up
When going into Apnea Back Up from CPAP in the EMV+® and Eagle II™ (NPPV and
PPV), and in the AEV® (NPPV only), the unit will automatically return to Pressure with the
following back up settings:
PIP Target
I:E OR TI
BPM
20
12
1:2.5 OR 1.42
All other parameters will remain as they were previously set. When leaving CPAP, the new
operating mode will be Pressure Targeted and will use Apnea Back Up settings as the new
settings.
Caution
These Apnea Back Up settings are appropriate for an adult. For pediatric and infant patients, the
operator should adjust the Apnea Back Up settings so they are appropriate for the patient.
8. Confirm/Select -- Press the CONFIRM/SELECT button to confirm a new control setting
or to select from a menu or setting option. The CONFIRM/SELECT button switch is
labeled with a green check mark “√”.
9. Power Off/On -- Turn the POWER OFF/ON switch to apply or remove operating power to
the unit.
10. Manual Breath -- Pressing the MANUAL BREATH button delivers one control breath
based on the VT or PIP settings. If the MANUAL BREATH button is pressed during
inspiration or before baseline is reached in the expiratory period, a manual breath will not be
triggered. If there is incomplete exhalation, it will not be possible to trigger a manual breath.
This is to prevent accidental breath stacking. When operating in CPAP, a breath is delivered
using the PIP value from the Apnea Back Up settings.
11. Rotary Encoder -- Turn the ROTARY ENCODER to change a value or highlight a
particular menu option.
12. Mute/Cancel -- Press the MUTE/CANCEL button to mute most Medium Priority alarms, to
cancel/acknowledge Low Priority alarms, or to cancel an action that is no longer desired (for
example: a parameter value change). Pressing the MUTE/CANCEL button can also be used
to cancel any current operation and return to the normal operating screen.
The MUTE/CANCEL button switch is labeled with a red “X”
13. Menu -- Pressing the MENU button provides access to user menus and special functions.
Use the ROTARY ENCODER to scroll to the desired menu option and press the
CONFIRM/SELECT button to access the menu control. Pressing CONFIRM/SELECT
then accesses the parameter variable which is changed by turning the ROTARY ENCODER
to the desired value. To accept the new parameter value, press the CONFIRM/SELECT
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(the highlight moves from the parameter variable back to the parameter label). For
parameters with multiple options, pressing CONFIRM/SELECT opens a submenu where
the various parameters are selected using the ROTARY ENCODER and changed using the
process described above. At any point, the operator can cancel an operation, return to the
previous menu level, or exit the menu control by pressing the MUTE/CANCEL button.
1. Alarm Configuration -- allows the operator to disable the audible and visible alarm
alerts associated with specific alarm in order to prevent nuisance alarms. While the
menu shows all of the alarms that can be disabled, the system only allows you to disable
active alarms. This approach assures that the operator has been advised of the alarm and
has decided that it does not affect safe and effective management of the patient. It is
important to recognize that Low Priority alarms are Advisory and the patient and device
are performing as configured, but there is information that could affect management of
the patient.
2. Power Up Settings -- allows the operator to select startup settings different from the
factory defaults. The menu allows the operator to select the current ventilator settings for
use at startup. There are 3 options: default, user 1, and user 2. User 1 and user 2 allow the
operator to establish different startup settings based on the intended patient population.
ZOLL is constantly focused on providing clinically safe, effective and timely support to
patients requiring ventilator support as well as ease of use to their care providers. The
initial focus and area for application of the unit platform is Acute Patient Care in many
varied and austere environments. This patient area of need has historically been the
Adult range of patients. ZOLL has used this historical data and experience as
its rationale for the unit to start-up in the Adult patient Assist-Control Volume mode and
associated parameters which have been deemed as clinically safe and acceptable starting
points and limits by international experts and standards committees.
ZOLL also strives to provide user-friendly options to our customers and allow them to
set up certain USER Start-up selected modes after their acquisition of the equipment as
they know best what their patient base and needs for mechanical ventilatory support are
within their respective region or facilities. Realizing that varied levels of need and
experience exist, as well as knowing that each patient is different and clinician
assessment is required prior to application to the patient, certain mode and parameter
configurations are not available as User setup options in an effort to maximize patient
safety.
To configure startup settings other than the default, press the MENU button, select
POWER UP SETTINGS; select SAVE SETTINGS and select either user 1 or user 2
and press CONFIRM/SELECT. To start with the new setting, select POWER UP
WITH and select which user setting you would like to use at startup and press
CONFIRM/SELECT. Assure the proper startup setting by turning the ventilator off
then on again. The unit will being operation with the new settings. Limits for stored
parameters are shown on the table below. Default startup modes are limited to AC and
SIMV (SIMV available for EMV+® and Eagle II™ only); CPAP cannot be stored as a
stored default.
2-14
Parameter
Limitations
VT Setting
≤1000 ml
VT High Limit
10ml resolution, only recalled if the target is pressure or in SIMV(V)
VT Low Limit
10ml resolution, only recalled if the target is pressure or in SIMV(V)
Constant I time vs. constant I:E
No limit
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906-0731-01 Rev. M
Controls and Indicators
Caution
Parameter
Limitations
Target (P or V)
No limit
BPM
6 to 60
BPM High Limit
No limit
BPM Low Limit
>6 bpm
I time
No limit
PIP Target
≤35 cmH2O
PIP High Target
≤35 cmH2O
PIP Low Target
No limit
PEEP
No limit
The operator should set the PIP Low Limit to be at least PEEP + 5. This is to reduce the
likelihood of not detecting a kinked hose. If the PIP Low Limit is set > PEEP and < PIP, the PIP
Low Limit can also serve as a PEEP compensated disconnect threshold.
3. Pulse Oximeter -- allows the operator to turn the pulse oximeter on or place it in standby.
4. Trigger Lever -- allows the operator to adjust the assisted breath trigger from -6 to -0.5
cm H2O to optimize the patient/ventilator interaction; the default value is -2 cm H2O
below baseline. The setting is not retained when the device is powered off.
Caution
The operator should take care in setting the trigger level so as to minimize work of breathing and
prevent auto-triggering. Ventilating infants and other patients with weak inspiratory effort, the
trigger threshold should be reduced (>-2 cm H2O) to reduce the work required for the patient to
trigger a breath. During NPPV with a large leak, the trigger threshold may need to be increased
to prevent auto-triggering with the variable baseline pressure.
5. O2 Reservoir -- allows the operator to tell the device that the 3-liter O2 Reservoir
Assembly is in use. Using the reservoir can cause a Fresh Gas Intake Fault alarm to occur.
Turning this function on disables this alarm and prevents nuisance alarms. The device is
still able to detect and alarm if the Fresh Gas/Compressor Intake is blocked and the
compressor is not able to deliver its contribution to the breath. Operation in extremely
high vibration environments can also trigger this alarm. Using this mode in these
situations can reduce nuisance alarms. The setting is not retained when the device is
powered off.
6. Unit Info -- lists the serial number for the unit and Smart Pneumatic Module (SPM),
software version, hours of use, and last calibration date.
A. Date: the current date (day/month/year), based on the time and date when the
calibration was performed.
B. Cal date: displays the date of the last calibration.
C. Hours of Op: displays the hours of operation since the last calibration.
D. EMV Soft Rev: displays the ZOLL ventilator software revision that is in use with
the device.
E. EMV SN: displays the serial number of the ZOLL ventilator.
F. SPM Soft Rev: displays the SPM software revision that is in use with the device.
G. SPM SN: displays the serial number of the SPM.
H. EMV Model: displays the model number of the EMV portion of the ZOLL
ventilator.
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CHAPTER 2 PRODUCT OVERVIEW
I. SPM Model: displays the model number of the SPM portion of the ZOLL
ventilator.
7. Contrast -- allows the operator to adjust the contrast of the LCD to optimize visibility in
the current lighting environment. The default is 213; increasing the value increases the
contrast while decreasing the value decreases the contrast. During cold weather operation
(below 0°C), the contrast can fade. The operator can improve visibility by increasing the
contrast. During operation at temperature extremes, the device may start with the display
not clearly visible. In these situations, the operator can directly access the contrast control
by pressing and holding the Menu and then adjusting the contrast with the ROTARY
ENCODER.
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906-0731-01 Rev. M
Controls and Indicators
Display Screen
The LCD parameter windows present information relating to settings, menus/instructions,
alarm information, pressure measurement data, pulse oximeter data, and heart rate data. When a
parameter, secondary parameter, or alarm limit is associated with an active alarm, the parameter
flashes to help the operator better understand the nature of the alarm condition.
Display Screen
A. HR -- Displays the HR and Low/High HR alarm limits. A heart icon is also displayed in this
window when the pulse oximeter is in use. The icon flashes in sequence with the patient’s
heart rate. Immediately to the left of the HR and SpO2 parameter windows is the pulse
oximeter pleth display. When no alarms are present, the pleth is displayed. When alarms
occur, the pleth is removed to allow room for the alarm name and mitigation instructions.
When a Low priority alarm is muted, the pleth is returned to the screen. For all priority
alarms, the LED indication lights remain active even if the alarm information is not shown
on the screen.
B. SpO2 -- Displays the SpO2 and Low/High SpO2 alarm limits.
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CHAPTER 2 PRODUCT OVERVIEW
C. FIO2 -- Displays the set fraction of inspired oxygen. The window also displays the O2 Use
value.
D. PIP -- Displays the peak airway pressure, PEEP, and Low/High PIP alarm limits. During
volume targeted ventilation, the PIP is displayed as outlined text to remind the operator that
it is dependent on the set volume and patient’s respiratory mechanics.
E. VT -- Displays the set tidal volume during volume targeted ventilation. During pressure
targeted ventilation, it displays the delivered tidal volume. This is indicated by the outlined
text and by displaying (Del) next to VT. In pressure targeted ventilation, the Low/High tidal
volume alarm limits are displayed.
F. BPM -- Displays the set breath rate, the Low/High breath rate alarm limits, and either the
I:E ratio or inspiratory time (depending on the operator configuration). During operation in
CPAP, the BPM primary parameter is the patient’s actual breathing rate in outlined text.
G. Mode -- Displays the operating mode and the breath target (V) for volume or (P) for
pressure. The upper right corner of this window also displays if the unit is in the NPPV
adjunct (Noninvasive Positive Pressure Ventilation) or the default PPV adjunct (Positive
Pressure Ventilation).
H. Status Indicator LED Array -- The Status Indicator LED Array contains green, yellow,
and red LED’s. During normal operation, the Status Indicator LED Array is enabled.
• Green -- Indicates operating power and that all ventilator and patient parameters
are operating as intended.
• Yellow -- Indicates that a Low Priority alarm has been detected or that a persistent
alarm condition is active. The unit will continue to operate within its safety limits
while the yellow LED provides a constant reminder that although it was
acknowledged, the condition remains.
• Red -- Indicates High and Medium Priority alarm conditions. The Alarm LED
flashes when the alarm occurs.When the MUTE/CANCEL button is pushed, the
LED illuminates continuously during the 30 seconds that the audible alarm is
muted during Medium Priority alarms. Pressing the MUTE/CANCEL button
during High Priority alarms has no effect.
I. Pulse Pleth/Time Plot -- Displays the pulse pleth waveform if no medium/high priority
alarms are displayed.
J. Pressure/Time Plot -- Displays the PIP versus time plot if no medium/high priority alarms
are displayed. The numbers indicate the PIP readings, and are not displayed when the PIP is
above/below the PIP limits. This pressure information is to assist both in diagnostic
evaluation and in setting the rise time.
Note:
When no alarms are present, the pulse pleth/time and pressure/time plots are
displayed. When alarms occur, the plots are removed to allow room for alarm name
and mitigation instructions. When a low priority alarm is muted, the plots are
returned to the screen. For all priority alarms, the LED indication lights remain
active even if the alarm information is not shown on the main screen.
K. Current Mode -- Displays the current Mode plus any adjuncts that are in effect (for
example, CPAP + NPPV, AC(Volume) etc.) The pressure value for the pressure support (PS)
is indicated by the number (cm H2O) in parenthesis after PS (for example, PS (40)).
L. External Power Icon/Indicator -- Indicates the presence of external power. When no
external power is sensed, the icon/indicator presents with a diagonal line. If an External
Power Low or External Power Fail/Disconnect alarm occurs, the icon flashes off/on.
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906-0731-01 Rev. M
Controls and Indicators
M. Battery Icon/Indicator -- Indicates (1) the presence of a functional battery, (2) when the
battery is charging, and (3) the current battery capacity. The Battery icon appears in outline
form and is filled with horizontal lines indicating its current capacity. When the battery is
charging, these horizontal lines cyclically scroll vertically, one row at a time, from the
bottom to the top. The scroll rate is faster when the battery is charging faster and it slows
down when slower trickle charging. The charge level is indicated numerically under the
battery icon. When the battery is fully charged, the icon is completely filled and scrolling
stops. Each line represents approximately 5% of battery capacity. During internal battery
operations, a horizontal line is removed with each 5% decrement of battery capacity. The
Battery icon will flash off/on when a Battery Power Low alarm occurs. The icon will flash
off/on and present with a diagonal line when no battery is connected.
N. Oxygen Supply Icon/Indicator -- Indicates the presence of external high-pressure oxygen
(55 psig source). The icon only appears when high-pressure oxygen is detected by the
pressure transducer. The icon flashes off/on when the Oxygen Low/Fail alarm occurs.
O. Speaker (Mute or Unmute) Icon/Indicator -- Indicates whether the alarm sound has been
muted or is active. The Muted speaker icon is present during the startup 2 minute mute, with
the remaining muted time indicated under this icon.
O. Head with Mask Icon/Indicator -- Indicates if the NPPV adjunct is in effect for ventilatory
support of spontaneously breathing patients. This icon replaces the Unmuted Speaker and/or
the Muted Speaker icon for Low priority alarms. (This icon does not appear if a Medium
priority alarm has been muted.)
P. Alarm Triangle Icon/Indicator -- Indicates if there is an active alarm. The priority of the
alarm is indicated by the interior of the triangle: empty for Low priority, one exclamation
point for Medium priority, and two exclamation points for High priority.
Q. Airway Pressure/Measured Values -- Provides a continuous display of airway pressure. Its
absolute range is from -10 to 100 cm H2O ATPD with a horizontal resolution of 1cm
H2O/pixal. The scale below the indicator is graduated in 10 cm H2O increments with
numerical markers appearing at 0, 50, and 100 cm H2O. Above the bar graph, measured
values for delivered minute volume, mean airway pressure (MAP), and actual breathing rate
(set plus spontaneous) are displayed.
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CHAPTER 2 PRODUCT OVERVIEW
Pop Up messages
To prevent setting of unwanted or inadvertent parameter values that are outside the typical
clinical range of settings, the unit presents Pop Up messages that ask the operator if they are
sure they would like to set the parameter beyond the typical range. When a message occurs, the
operator is asked to press the CONFIRM/SELECT button before they can adjust a parameter
beyond the typical range. Pop Up messages are also used to alert the operator that certain
settings are not permitted. In addition, Pop Up messages can call for the operator to
CONFIRM/SELECT that they are entering configurations where certain alarms are being
suppressed, turned “off”, and/or cancelled.
Pop Up Message Example
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906-0731-01 Rev. M
Controls and Indicators
The following is an alphabetical list of all Pop Up messages and their meaning:
Pop Up Message
Explanation
ALARM DISABLE
Confirmation required-press accept key to disable alarm
BPM LIMIT CONFLICT
Cannot adjust high limit lower than low limit
BPM LIMIT CONFLICT
Cannot adjust low limit higher than high limit
BPM SETTING CONFLICT
I Time cannot exceed 3 seconds
BPM SETTING CONFLICT
I:E > 1:99 not allowed
CPAP + NPPV
Some Alarms Disabled! Configure Alarms for Patient!
HEART RATE LIMIT CONFLICT
Cannot adjust high limit lower than low limit
HEART RATE LIMIT CONFLICT
Cannot adjust low limit higher than high limit
HIGH PRESSURE TARGETING
SETTING
Confirmation required-press accept key to exceed 60 cm H2O
HIGH VT LIMIT SETTING
Confirmation required-press accept key for values above
1500ml
HIGH VT SETTING
Confirmation required-press accept key to allow VT > 1000ml
I TIME RANGE EXCEPTION
I Time cannot exceed 3 seconds
I TIME RANGE EXCEPTION
I Time must be greater than 0.3 seconds
I:E RANGE EXCEPTION
I:E > 1:99 not allowed
I:E RANGE EXCEPTION
Inverse I:E not allowed
LOW BREATH RATE SETTING
Confirmation required-press accept key for values below 6
BPM
PEEP BACKUP SETTING
CONFLICT
Cannot adjust PEEP target to within 5 of backup PIP target
PEEP SETTING CONFLICT
Cannot adjust PEEP target to within 5 of PIP High Limits
PEEP SETTING CONFLICT
Cannot adjust PEEP target to within 5 of PIP target
PEEP SETTING CONFLICT
PEEP + PS cannot be greater than PIP High Limit
PEEP + PS SETTING CONFLICT
PEEP + PS must be ≥ 3 cm H2O, Adjust Setting to Assure
Patient Safety
PIP LIMIT BACKUP SETTING
CONFLICT
Cannot adjust high limit lower than backup PIP target
PIP LIMIT CONFLICT
Cannot adjust high limit lower than low limit
PIP LIMIT CONFLICT
Cannot adjust high limit lower than PIP target
PIP LIMIT CONFLICT
Cannot adjust high limit lower than PS + PEEP
PIP LIMIT CONFLICT
Cannot adjust low limit higher than high limit
PIP SETTING CONFLICT
Cannot adjust PIP target higher than PIP High Limit
PIP SETTING CONFLICT
Cannot adjust PIP target to less than 5 more than PEEP
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CHAPTER 2 PRODUCT OVERVIEW
Pop Up Message
2-22
Explanation
PS CONFLICT
Cannot adjust PS higher than PIP High Limit - PEEP
REQUESTED COMPRESSOR
FLOW TOO HIGH
Cannot exceed 100 LPM total flow
REQUESTED COMPRESSOR
FLOW TOO LOW
Reduce FIO2, increase BPM, reduce I Time, or increase VT
REQUESTED O2 FLOW TOO
HIGH
Cannot exceed 100 LPM total flow
REQUESTED O2 FLOW TOO
LOW
Reduce FIO2, increase BPM, reduce I Time, or increase VT
TOTAL REQUESTED FLOW TOO
HIGH
Cannot exceed 100 LPM total flow
TOTAL REQUESTED FLOW TOO
LOW
Cannot flow less 2 LPM total flow
VT LIMIT BACKUP SETTING
CONFLICT
Cannot adjust high limit lower than Backup VT Setting
VT LIMIT BACKUP SETTING
CONFLICT
Cannot adjust low limit higher than Backup VT Setting
VT LIMIT CONFLICT
Cannot adjust high limit lower than low limit
VT LIMIT CONFLICT
Cannot adjust high limit lower than VT Setting
VT LIMIT CONFLICT
Cannot adjust low limit higher than high limit
VT LIMIT CONFLICT
Cannot adjust low limit higher than VT Setting
VT LIMIT CONFLICT
Cannot adjust VT Setting above VT High Limit
VT LIMIT CONFLICT
Cannot adjust VT Setting above VT Low Limit
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906-0731-01 Rev. M
Set-up
Set-up
The unit can be configured to suit most applications. Additional hoses, fittings, and adapters
may be required for particular uses.
1. For use with external oxygen: connect a green (white for some installations) high-pressure
oxygen hose to the OXYGEN IN fitting and a 55 psig external source.
Note:
Use only with medical-grade (USP) oxygen. When using with an oxygen cylinder,
the cylinder must be secured.
2. Connect the disposable ventilator circuit to the GAS OUTPUT, TRANSDUCER, and
EXHALATION VALVE connectors on the unit’s Connector Panel. Follow the directions
included with the disposable ventilator circuit.
3. In a high-dust or biological environment, a bacterial/viral filter should be attached to the
Fresh Gas/Emergency Air Intake to prevent entrainment of particulate or biological matter.
(See “Hazard Environment Filters” section.)
4. In toxic biological or chemical environments, the operator can attach a chemical/biological
filter to the Fresh Gas/Emergency Air Intake. The threaded interface accommodates
chemical/biological filters with an Rd 40 x 1/7 interface (see BS EN 148-1 1999 Respiratory
protective devices-threads for face pieces). (For more information, see the “Hazard
Environment Filters” section of this manual.)
5. For use with AC power: connect the AC/DC Power Supply (supplied) to the External Power
Input.
Note:
The unit can operate from internal batteries or from external AC or DC power
sources.
Warning!
Always assure that there is an alternate means of providing ventilation. A bag-valve
resuscitator and an appropriate mask for the patient being ventilated should be
immediately available.
Warning!
This unit’s USB connection does not provide any signal output or input to the operator.
It is for the use of ZOLL-trained personnel only. The operator should not connect
anything to the USB connection.
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CHAPTER 2 PRODUCT OVERVIEW
External Gas Sources
The unit can operate using high-pressure oxygen from either oxygen cylinders or piped oxygen
sources, as illustrated below:
External Gas Sources
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906-0731-01 Rev. M
Set-up
The duration of use for a gas cylinder depends on the size and pressure of the cylinder, and the
rate at which gas is being used to support the patient. The formula to calculate the operating
duration of any cylinder (based on the Ideal Gas Law) is given below. An example is worked
out for a typical large cylinder. It is recommended that the gas cylinder pressure not be allowed
to fall below 300 psi.
V start = 9540 liter at 1 atm/ 70F (21C): from label on cylinder
P start =2640 psig: from label on cylinder
P present in cylinder = 300 psig: from pressure gauge on cylinder
V present in cylinder = volume remaining in cylinder = (P present/ P start) V start = 1084 liter at
1 atm/ 70°F (21°C)
V delivered = 9540 - 1084 = 8456 liter at 1 atm/ 70°F (21°C)
For a typical ventilator setting (20 BPM, VT = 500 mi, FIO2 = 100%, I time = 1 sec,
I:E = 1:2:0), the gas consumption is 10 liter/min.
Note:
Whenever external high-pressure oxygen is used, the unit automatically determines the
oxygen usage and displays it in the FIO2 parameter window. (See O2 Use under FIO2
in “Description of Controls and Display.”)
Total duration of the gas cylinder in the above example = V delivered/(10 liter/min) = 8456/10
min = ~14 hours.
Fresh Gas/Emergency Air Intake
Warning!
Never block the Fresh Gas/Emergency Air Intake. A free flow of air is required during
compressor operation or in the event of a device failure to allow spontaneous breathing.
The Fresh Gas/Emergency Air Intake also acts as an anti-asphyxia port in the event of a
ventilator failure.
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CHAPTER 2 PRODUCT OVERVIEW
Ventilator Circuits: Connections
The unit is designed to operate using a standard disposable ventilator circuit. The circuit is
attached to the ventilator as shown below:
Ventilator Circuit Device Connections
Caution
2-26
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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906-0731-01 Rev. M
Set-up
Ventilator Circuits: Patient Connections
The unit uses two different single limb vent non-MRI circuits to support patients from ≥ 5 kg to
adult: Infant/Pediatric (Part #820-0107-00) and Pediatric/Adult (Part #820-0106-00). Similar
circuits (differing only in hose length) are available for use in an MRI environment:
Infant/Pediatric (Part #820-0131-00) and Pediatric/Adult (Part #820-0130-00). The circuits are
illustrated below:
Ventilator Circuit, Patient Connections
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CHAPTER 2 PRODUCT OVERVIEW
Ventilator Circuits: Resistance, Compliance, and Deadspace
Appropriate ventilation depends on the patient lung volume, which is related to the patient
weight. Based on Ventilation Standards, patients are divided into three categories (Infant,
Pediatric, and Adult). The details of these patient categories and the Flow required by
regulations for Resistance measurement are indicated in the following table:
Patient
Patient Weight (kg)
Resistance measured at Flow (l/min)
Adult
≥ 40
60
Pediatric
12-50
30
Infant
5-12
5
ZOLL provides four ventilator circuits depending on patient size and longer length required for
MRI operation, as indicated in the following table:
Ventilation Circuit
ZOLL Part Number
Warning!
Dead Space (ml)
Pediatric/Adult
#820-0106-00
Do not use on Infant patients.
17
Pediatric/Adult-MRI
#820-0130-00
Do not use on Infant patients.
17
Infant/Pediatric
#820-0107-00
Do not use on Adult patients.
4.2
Infant/Pediatric-MRI
#820-0131-00
Do not use on Adult patients.
4.2
Warning!
Adult patients should only be ventilated with Pediatric/Adult circuits. Infant patients
should only be ventilated with Infant/Pediatric circuits.
Pediatric patients can be ventilated with either the Pediatric/Adult or Infant/Pediatric circuits.
However, ventilation of Pediatric patients in the higher weight range (30-40 kg) with
Infant/Pediatric circuits requires gas flows that result in noisy operation. There is no patient risk
to this noise, except that it could disturb the patient and distract the operator. To avoid this
noise, the recommended Pediatric patient weight ranges for use with the various circuits, and
the corresponding Resistance and Compliance measurements, are indicated in the following
table:
Standard Circuit Length
Patient
Recommended
Patient Weight
(kg)
Inspiratory
Resistance
(cm H2O)
Breathing Circuit
Expiratory
Resistance
(cm H2O)
Compliance
(ml/cm H2O)
Adult
≥ 40
Pediatric/Adult
1.44
4.82
1.2
Pediatric
12-50
Pediatric/Adult
0.39
2.99
1.2
Pediatric
12-30
Infant/Pediatric
5.99
5.21
0.44
Infant
5-12
Infant/Pediatric
0.24
1.78
0.44
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Set-up
MRI Longer Circuit Length
Patient
Recommended
Patient Weight
(kg)
Breathing Circuit
Inspiratory
Resistance
(cm H2O)
Expiratory
Resistance
(cm H2O)
Compliance
(ml/cm H2O)
Adult
≥ 40
Pediatric/Adult
2.33
4.44
2.1
Pediatric
12-50
Pediatric/Adult
0.65
2.63
2.1
Pediatric
12-30
Infant/Pediatric
1.28
1.75
0.75
Infant
5-12
Infant/Pediatric
0.39
1.25
0.75
Warning!
If circuits with different resistance/compliance are used or additional adjuncts are
placed in line with the circuit, the operator must make sure that the appropriate circuit
resistance/compliance factors for the new circuit are used as well as dead space volume
of the added adjunct(s) is/are factored into the equation for effective tidal volume
delivery to the patient.
Operating Power Selection and Stopping
The POWER switch is the master power switch. Use this switch to indicate or end operation.
The unit is designed to operate using any one of three power sources:
1. Internal 14.8V lithium ion (Li Ion) rechargable battery with 6.6 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 (110-240 VAC 50/60 and 400 Hz--ZOLL verified testing,
and 110-240 VAC 50/60--SGS listed) with IEC 320 style AC input connector (supplied). 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 the 12 or 28 VDC Power Cables.
The input connector of the EMV+ is designed to accept DC voltages between 12.5 to 28.0
VDC +/- 10% volts, negative ground.
Caution
When using the standard vehicle DC outlet, the vehicle should not be jump started during
operation of the ventilator.
Warning!
Never start the ventilator with the patient connected. Always start the ventilator, select
the patient settings, ensure operation, and then connect the patient. Always manually
ventilate the patient when they are not connected to the ventilator.
The unit is designed to use external power when available rather than its internal battery pack.
When an acceptable external power source is present, the internal battery pack is automatically
charged while the unit operates. When an external power failure occurs, the unit automatically
switches to its internal battery pack for operating power and activates the EXTERNAL POWER
FAILURE alarm; there is no interruption in operation and/or loss of any alarms. When external
power returns, operating power automatically switches from internal power to the external
source. In the event that the device needs to be shutdown, the procedure consists of turning the
POWER switch to the OFF (“O”) position. If this fails to work or puts the patient or operator at
possible risk, the device should be disconnected for the mains power.
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CHAPTER 2 PRODUCT OVERVIEW
Power Supply Connections
The following illustration demonstrates how to properly connect the external power cable.
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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Set-up
Self-Check
At start up, the unit automatically performs a self-check that includes a check for pre-existing
alarm conditions. Following start up, the presence of alarm conditions is checked continuously.
The ventilator circuit must be open to ambient atmosphere (not connected to the patient) during
start up. Ventilator operation begins immediately following the self-check.
Warning!
Until the operator has determined that the ventilator is functioning properly and that
the ventilator parameters are set correctly for the patient, the patient should not be
connected to the ventilator.
Transducer Calibration (AUTO CAL)
The AUTO CAL affects 3 transducer systems: Compressor Flow, Oxygen Flow, and Airway
Pressure. Its purpose is to compensate for small temperature related drifts in the transducer
offset (zeroing). The AUTO CAL is performed during self-check, and then every 5 minutes
thereafter. However, if a temperature change exceeding +/- 1.5°C is sensed, the AUTO CAL
time interval is reduced automatically to assure a stable pressure measurement baseline.
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CHAPTER 2 PRODUCT OVERVIEW
Pulse Oximeter Principles
The Masimo SET® MS board pulse oximeter is based on three principles:
1. Oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light
(spectrophotometer).
2. The volume of arterial blood in tissue and the light absorbed by the blood changes during
the pulse (plethysmography).
3. Arterio-venous shunting is highly variable and that fluctuating absorbance by venous
blood is a major component of noise during the pulse.
The Masimo SET MS board pulse oximeter as well as traditional pulse oximetry determines
SpO2 by passing red and infrared light into a capillary bed and measuring changes in light
absorption during the pulsatile cycle. Red and infrared light-emitting diodes (LEDs) in
oximetry sensors serve as the light sources, a photodiode serves as the photodetector.
Traditional pulse oximetry assumes that all pulsations in the light absorbance are caused by
oscillations in the arterial blood volume. This assumes that the blood flow in the region of the
sensor passes entirely through the capillary bed rather than through any arterio-venous shunts.
The traditional pulse oximeter calculates the ratio of pulsatile absorbance (AC) to the mean
absorbance (DC) at each of two wavelengths, 660 nm and 905 nm:
S(660) = AC(660)/DC(660)
S(905) = AC(905)/DC(905)
The oximeter then calculates the ratio of these two arterial pulse-added absorbance signals:
R = S(660)/S(905)
This value of R is used to find the saturation SpO2 in a look-up table built into the oximeter’s
software. The values in the look-up table are based upon human blood studies against a
laboratory co-oximeter on healthy adult volunteers in induced hypoxia studies.
The Masimo SET MS board pulse oximeter assumes that arterio-venous shunting is highly
variable and that fluctuating absorbance by venous blood is the major component of noise
during the pulse. The MS board decomposes S(660) and S(905) into an arterial signal plus a
noise component and calculates the ratio of the arterial signals without the noise:
S(660) = S1 + N1
S(905) = S2 + N2
R = S1/S2
Again, R is the ratio of two arterial pulse-added absorbance signals and its value is used to find
the saturation SpO2 in an empirically derived equation into the oximeter’s software. The values
in the empirically derived equation are based upon human blood studies against a laboratory
co-oximeter on healthy adult volunteers in induced hypoxia studies.
The above equations are combined and a noise reference (N’) is determined:
N’ = S(660) - S(905) x R
If there is no noise, N’ = 0: then S(660) = S(905) x R, which is the same relationship for
traditional pulse oximeter.
The equation for the noise reference is based on the value of R, the value being sought to
determine the SpO2. The MS board software sweeps through possible values of R that
correspond to SpO2 values between 1% and 100% and generates an N’ value for each of these
R-values. The S(660) and S(905) signals are processed with each possible N’ noise reference
through an adaptive correlation canceler (ACC), which yields an output power for each
possible value of R (i.e., each possible SpO2 from 1% to 100%). The result is a Discrete
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Pulse Oximeter Principles
Saturation Transform (DST™) plot of relative output power versus possible SpO2 value as
shown in the following figure where R corresponds to SpO2 = 97%:
Pulse Oximeter Discrete Saturation Transformation
The DST plot has two peaks: the peak corresponding to the higher saturation is selected as the
SpO2 value. This entire sequence is repeated once every two seconds on the most recent four
seconds of raw data. The MS board SpO2 therefore corresponds to a running average of arterial
hemoglobin that is updated every two seconds.
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Chapter 3
Operation
Overview
Introduction
The ZOLL ventilator is a volume and pressure targeted, time or flow cycled ventilator designed
to use either oxygen from a 55 psig source or fresh air using its internal compressor to deliver a
positive pressure breath. The user interface allows the operator to initiate the unit at default
setting values.
When high-pressure oxygen is connected, the internal blender allows the FIO2 to be set from 21
to 100%. Backpressure from the patient connection does not affect the delivered accuracy of
the volume, flow, pressure, or FIO2. When the FIO2 is set to 21%, operators may connect a low
flow oxygen source at the Fresh Gas/Emergency Air Intake using the reservoir (See “Use of
Low Flow Oxygen” section). A suite of alarms alert the operator when conditions exceed
parameter limits or when operation is affected by an external or internal fault or failure. When
an alarm occurs, the operator is alerted by audible and visual indicators while context sensitive
help messages are displayed in the LCD’s Alarm Message Center. Operating power is from an
external AC/DC power converter connected to live AC mains, external DC power, or from the
internal rechargeable lithium ion battery. Fresh air is filtered using a particulate filter or, when
the operating environment requires, a bacterial/viral filter or a chemical/biological filter may be
attached.
When the unit is first powered up, certain patient circuit alarms are preemptively muted for
120 seconds, to allow the operator time to attach the patient circuit, pulse oximeter, and
properly adjust the ventilator without nuisance alarms. For a list of these preemptively muted
alarms, see the “Alarms Turn Off & Cancellation” section. The time remaining for the mute
period is displayed on a countdown clock shown beneath the speaker icon.
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Pulse Oximeter
At start up, the pulse oximeter is in standby (pulse oximeter on and ready to monitor) and the
parameter windows for SpO2 and Heart Rate read stby and operational alarms are suppressed.
As soon as a valid patient signal is detected ≥ 10 seconds, the pulse oximeter comes out of
standby, a pulse search is performed to obtain the optimum signal and then the parameters are
displayed, and all alarms are active. The pulse oximeter can be turned on via the “Pulse
Oximeter” submenu in the main menu by changing stby to On. Similarly, if the probe is
removed from the patient and monitoring is no longer desired, the pulse oximeter can be placed
back in standby via the “Pulse Oximeter” menu submenu. See the “Pulse Oximeter Principles”
section and the “Pulse Oximeter” section of “Specifications”.
The pulse oximeter and its accessory probes and cables are intended for continuous
noninvasive monitoring of arterial hemoglobin (SpO2) and pulse rate (measured by the SpO2
sensor) for adult, pediatric and infant patients using the appropriate sensor for the patient. The
pulse oximeter is operational in all ventilator modes when its cable and sensor are properly
attached to the SpO2 connector.
To operate the pulse oximeter, connect the probe to the patient cable and the patient cable to the
SpO2 connector on the unit. The monitoring function will continuously display the patient’s
pulse rate and SpO2 value. See the Pulse Oximeter Alarms in the Ventilator Alarm Categories
section for more information on pulse oximeter alarms.
Note:
The pulse oximeter can only be placed in standby when the probe is disconnected from
the patient. A valid signal will automatically bring the pulse oximeter out of standby.
The pulse oximeter reading can be affected by the following conditions:
1. The sensor is too tight.
2. There is excessive illumination from light sources such as a surgical lamp, a bilirubin
lamp, or sunlight.
3. A blood pressure cuff is inflated on the same extremity as the one with a SpO2 sensor
attached.
4. The patient has hypotension, severe vascoconstriction, severe anemia, or hypothermia.
5. There is an arterial occlusion proximal to the sensor.
6. The patient is in cardiac arrest or is in shock.
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Operation
Operation
The unit has been designed to ease the learning transition commonly associated with new
equipment. Turning the POWER switch to “1” starts an internal Self Check and begins
operation with the default settings. The operator has the option of delivering volume targeted or
pressure targeted breaths. An internal blender enables the unit to deliver oxygen concentrations
from 21 to 100% using its internal compressor and/or a standard medical-grade oxygen source.
Additionally, low-pressure oxygen can be entrained through the Fresh Gas/Compressor Intake
using the reservoir accessory except when a chemical/biological filter is connected. When
using the reservoir, the FIO2 should be set to 21% and enable the O2 Reservoir mode from the
User Menu (enabling this avoids nuisance alarms from the compressor inlet sensors). The
operator should titrate the flow of oxygen to the reservoir to maintain an adequate SpO2 value.
O2 Reservoir mode is indicated on the display with a plus “+” sign next to the FIO2 value.
Modes of Operation
The unit offers a range of modes using both pressure and volume targeting that can be selected
to optimally manage the patient.
Assist/Control (AC) -- The patient receives either controlled or assisted breaths. When the
patient triggers an assisted breath, they receive a breath based on either the volume or pressure
target.
Synchronized Intermittent Mandatory Ventilation (SIMV) -- The patient receives
controlled breaths based on the set breathing rate. Spontaneous breaths can be either
unsupported demand flow or supported using Pressure Support. (This mode is not available in
the AEV® unit.)
Continuous Positive Airway Pressure (CPAP) -- The patient receives constant positive
airway pressure while breathing spontaneously. Spontaneous breaths can be either demand flow
or supported using Pressure Support.
EMV+®, Eagle II™: The default CPAP provides positive end-respiratory pressure with
and without Pressure Support. The operator has the option of adding leak compensation
(NPPV) if desired to support the patient. The minimum baseline pressure (PEEP) in
CPAP-NPPV is 3 cm H2O regardless of the Pressure Support setting.
AEV®: Only provides for CPAP with leak compensation (NPPV) with or without Pressure
Support. The minimum baseline pressure (PEEP) in CPAP-NPPV is 3 cm H2O regardless
of the Pressure Support setting.
Note:
In the SIMV(P), SIMV(V), and CPAP modes, the sum (PEEP + PS) must be ≥ 3 cm
H2O.
Note:
In transitioning from AC to either CPAP or SIMV, if the starting PEEP value is 3 cm
H2O or less, the PEEP shall be set to 3.0 cm H2O during the transition. (This is to
assure that there is never a situation when both the PS and PEEP are zero, which would
violate (PEEP + PS) ≥ 3 cm H2O.
Note:
Negative pressure is not available in the expiratory phase.
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Additional Adjuncts of Operation
In addition to Modes of Operation, the unit also provides various adjuncts that can be used to
manage the patient. Two adjuncts are Pressure Support (PS) and Noninvasive Positive Pressure
Ventilation (NPPV). The following table shows which adjuncts can be used with which modes.
It is possible to use more than one adjunct, if the mode permits.
Mode
Breath Target
Pressure Support (PS)
Noninvasive Positive Pressure Ventilation (NPPV)
AC
V&P
No
No
SIMV
V&P
Yes
No (SIMV is not available in AEV®)
CPAP
N/A
Yes
Yes (CPAP-NPPV is Automatic in AEV®)
Pressure Support (PS) -- Can be used to assist spontaneous breaths in both SIMV and CPAP
modes. To set pressure support, press and hold the PIP parameter button (while the mode is set
to either SIMV or CPAP), press the CONFIRM/SELECT button to highlight the PS value,
then turn the ROTARY ENCODER to the desired value. Once the desired value is selected,
press the CONFIRM/SELECT button to enable the value and then the MUTE/CANCEL
button to return to the main screen. The Current Mode display will denote the value of this
pressure support by the number (cm H2O) in parenthesis after PS (value).
Noninvasive Positive Pressure Ventilation (NPPV) -- Provides flow during the expiratory
phase to maintain the baseline pressure (CPAP) in spontaneously breathing patients with a
leaking airway or facemask. The amount of leak compensation depends on the leak flow rate
during the expiratory period and ranges from 0 to 15 liters/min and is automatically adjusted by
the ventilator in order to maintain the CPAP target. In the AEV® model, the NPPV is
automatically in place when the CPAP mode is entered.
Caution
The operator should take care in setting the VT alarms and trigger level. The trigger level should
be adjusted to minimize work of breathing and prevent auto-triggering. The VT alarms should
bracket average tidal volume so that pending respiratory failure (low tidal volumes) and
excessive leaks (high tidal volumes) are detected.
Caution
The transition into NPPV automatically sets the rise time to 3, which may be too fast for infants
and small children. Before using with an infant or small child, the operator should always
configure the ventilator appropriately before attaching the patient.
Warning!
In CPAP-NPPV, a VT that is lower than anticipated given the patient’s size may be an
indication that the patient is not able to adequately spontaneously ventilate.
To avoid nuisance alarms in patients with active leaks, operation using NPPV suppresses
certain alarms. The alarms which are suppressed are:
1. Incomplete Exhalation (Alarm #3091)
2. Insufficient Flow (Alarm #2095)
To start NPPV in either EMV+® and/or Eagle II™:
1. Press MODE button to highlight mode.
2. Select CPAP and press Accept.
3. Press MODE button until the PPV field is selected.
4. Adjust to NPPV.
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Operation
5. Pop Up message will appear and ask for confirmation.
6. Press Accept.
7. Once the patient has reached steady state, the alarms should be configured to closely
monitor the patient.
To start NPPV in AEV®:
1. Press MODE button to highlight mode.
2. Adjust to CPAP.
3. Pop Up message will appear and ask for confirmation.
4. Press Accept.
5. Once the patient has reached steady state, the alarms should be configured to closely
monitor the patient.
When the NPPV adjunct is in operation, the head with mask icon will appear in the location
used by the speaker/mute icons. Low and Medium priority alarms will cause this head with
mask icon to disappear. It will reappear when Low priority alarms are muted. When Medium
priority alarms are muted, the muted speaker icon will appear.
When transitioning to NPPV mode, the following parameters/alarm limits will automatically be
adjusted to the following default values:
Alarm/Parameter
CPAP into NPPV Default Value
High BPM Alarm
40
Low BPM Alarm
4
Low Airway Pressure Alarm
Off
PEEP
5 cm H2O
VT High Limit
Off
VT Low Limit
Off
Rise Time
3
Pressure Support
2 cm H2O
When transitioning from the NPPV mode to another mode, the following parameters/alarm
limits will reset to the default values. This is done to assure appropriate monitoring in an active
ventilating mode:
Alarm/Parameter
NPPV into CPAP Default Value
NPPV to P Default Value
High BPM Alarm
25
25
Low BPM Alarm
8
8
Low Airway Pressure Alarm
(PIP Target = -3)
(PIP Target = -3)
PEEP
No change
No change
VT High Limit
750
750
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Warning!
Alarm/Parameter
NPPV into CPAP Default Value
NPPV to P Default Value
VT Low Limit
250
250
Rise Time
No change
No change
Pressure Support
No change
If ACP, Pressure Support = 0
Never use the CPAP with or without Noninvasive Positive Pressure Ventilation (NPPV)
adjunct on a patient that is NOT spontaneously breathing and/or may stop
spontaneously breathing. CPAP is intended for ventilatory support, NOT ventilation.
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 value can be adjusted in the User Menu.
Operational Test Procedure
Before attaching the patient to the ventilator, the operator should perform an Operational Test to
ensure that the breathing circuit is properly attached and that the primary patient safety alarms
(PATIENT DISCONNECT, HIGH AIRWAY PRESSURE LIMIT) are functioning properly. The
test should be performed following connection of the breathing circuit.
Procedure:
1. With the breathing circuit connected, turn the POWER switch to ON, to allow the
ventilator to complete Self Check and begin operation with its default values.
2. The PATIENT DISCONNECT alarm should be active. (The audible alarm will be muted
during the 2 minute initial mute.)
3. Press the MANUAL BREATH button; gas should flow out of the patient connection
each time the button is pressed.
Note:
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.)
4. Close the patient port with a clean hand or gloved hand. During inspiratory phase, the
HIGH AIRWAY PRESSURE LIMIT alarm should activate after 2 breaths that reach the
PIP High Limit.
5. If the HIGH AIRWAY PRESSURE LIMIT 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.
6. After a breath or two, release the patient port while allowing the ventilator to operate. The
PATIENT DISCONNECT alarm should activate.
7. 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.
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Operation
8. 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 unit in for service.
9. 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.
Note:
The trigger automatically adjusts when the PEEP is changed.
To Begin Ventilating
Procedure:
1. Attach the disposable patient circuit to the ventilator. If you wish to use a Heat and
Moisture Exchanger (HME), attach it to the patient connector of the ventilator circuit.
2. Attach the AC/DC Converter to an appropriate AC power source if available.
3. Turn the POWER switch on to initiate the Self Check and start the ventilator. When Self
Check is complete, operation will begin at default values.
Parameter
Mode
BPM
VT
PEEP
FIO2
I:E
High PIP Limit
Default Value
AC(V)a
12
500 ml
5 cm
H2O
21%b
1:2.5
35 cm H2O
a. (V): indicates volume targeted ventilation
b. If external oxygen is attached, the default FIO2 will be 100%
Warning!
Default settings are intended to provide basic support and prevent unintended injury.
Particular care should be taken to adjust the ventilator appropriately before ventilating
infants and children. The ventilator should always be adjusted before placing the
patient on the ventilator.
4. Allow at least one breath to occur; during this time, the PATIENT DISCONNECT alarm
will activate as the ventilator does not detect the minimum required airway passage.
5. Attach the ventilator circuit connector1 to the patient’s endotracheal tube, tracheostomy
tube, or other airway that supports positive pressure ventilation2. Delivery of the first
breath will automatically cancel the PATIENT DISCONNECT alarm.
Warning!
During noninvasive ventilation, NEVER LEAVE THE PATIENT UNATTENDED!
Warning!
Avoid high airway pressure as this increases the risk of aspiration.
Warning!
Deadspace increases with mask ventilation; always follow the mask manufacturer’s
directions.
1. 22 mm OD/15 mm ID standard conical interface for use with respirator devices.
2. Other airways can include: laryngeal mask airway, esophageal obturator airway, and combination
esophageal-tracheal tubes though their use should be under the direction of the attending physician. See
AARC Clinical Practice Guideline, Management of Airway Emergencies Respiratory Care 1995;40(7):
749-760 Section 10.2.2.
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CHAPTER 3 OPERATION
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.
6. Once connected to the ventilator, carefully assess the following:
a. Attach the pulse oximeter probe and begin monitoring HR and SpO2 (See instructions
provided with the pulse oximeter)3.
b. Set the high and low HR alarms appropriately for the patient.
c. Set the low SpO2 limit appropriately for the patient.
d. Assess the patient’s breath sounds for bilateral ventilation.
e. If this is not possible, watch the rise and fall of the chest wall to determine if there is
adequate movement on both sides of the chest.
f. Check Airway Pressure indicator to determine the peak airway pressure. Set the high
and low airway pressure limits 5 to 10 cm H2O above/below the peak pressure. This
will prevent excess airway pressure and leaks.
g. Set the high and low tidal volume alarms and breathing rate during pressure-targeted
breathing.
Warning!
Always set the Low Airway Pressure Limit at least 5 cm H2O above PEEP. Ideally, the
value should be 5 cm H2O < PIP.
7. Start a record of the date, time, ventilator settings, power source, and patient status.
8. Check the patient and ventilator on a regular basis to assure adequate ventilation and
device performance. Listen for, and respond to, all alarms.
9. During transport, reassess the patient and ventilator at least every hour or whenever the
patient is moved. When operating on battery power, always monitor the battery charge.
Warning!
Do not leave the patient unattended.
To Change Settings
Each Parameter button of the unit is associated with a parameter window; each parameter
window has a primary parameter and as many as 3 secondary parameters that can be adjusted
by the operator based on the mode of operation and breath target. To adjust the primary
parameter, press the Parameter button one time; to adjust a secondary parameter, press the
Parameter button a second or third time. Each time you press the Parameter button, a different
parameter is highlighted in the parameter window. To change a primary or secondary
parameter, use the following sequence:
1. Press the Parameter button one or more times to select either the primary parameter or
secondary parameters.
2. With the appropriate parameter highlighted, turn the ROTARY ENCODER clockwise
or counterclockwise to raise or lower the value.
3. Press the CONFIRM/SELECT button switch “√” to complete the value change.
3. If the accuracy of any measurements does not seem reasonable, first check the patient’s vital signs by
alternate means and then check the pulse oximeter for proper functioning.
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Operation
4. At any time, the operator can exit from any operation by pressing the MUTE/CANCEL
button “X”.
Examples
Example 1-To change the ventilation rate from 12 to 16:
Step 1: Press the BPM button once.
Step 2: Turn the Rotary Encoder clockwise to 16.
Step 3: Press the Confirm/Select button.
Example 2-To change from volume targeted breaths to pressure targeted breaths:
Step 1: Press the Mode parameter twice.
Step 2: Turn the Rotary Encoder clockwise to switch from “(V)” volume to “(P)” pressure.
Step 3: Press the Confirm/Select button.
Back Up Ventilator
The unit contains a built-in back up ventilator mode that is designed to provide a limited degree
of operation should certain types of failures occur to the primary operating system. Depending
upon the pre-existing conditions at the time of failure, the backup ventilator will begin
operation in one of two ways:
1. If no pre-existing alarm condition(s) exists: backup operation will continue using the
current settings.
2. If a pre-existing alarm condition(s) exists: backup operation will revert to the startup
default settings (Mode AC (P), volume target, BPM 12, PIP 20 cm H2O, FIO2 21%, PEEP
5 cm H2O, I:E 1:2.5, PIP High Limit 35 cm H2O).
Pulse Oximeter
The pulse oximeter and its accessory probes and cables are intended for continuous
noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and
pulse rate (measured by the SpO2 sensor) for infant through adult patients. The pulse oximeter
becomes operational in all ventilator modes when its cable and sensor are properly attached to
the SpO2 connector.
To operate the pulse oximeter, connect the sensor probe and the patient cable to the SpO2
connector on the top of the ventilator. The monitoring function initiates automatically when a
valid patient signal is detected for > 10 seconds. The operator can set low and high alarm limits.
If an alarm occurs, the operator can use this mitigation to assess the condition of the patient and
as an aid in determining what intervention is required.
Humidification
Heat and Moisture Exchangers (HME’s) can be used with the unit. While HME’s may not be
suitable for all applications, they facilitate portability in a way that conventional humidifiers
cannot. The unit can be used with an optional HME or an optional HME/bacterial viral filter
(HMEF). The HME provides heat and moisture to the inspired gas by recycling the head and
moisture contained in the patient’s exhaled gas. Use of an HMEF may help reduce the risk of
cross contamination of biological pathogens that might be transmitted in the patient’s exhaled
gas. HMEs or HMEFs attach between the disposable ventilator circuit and patient’s
endotracheal tube. Be sure to follow all instructions provided by the manufacturer.
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The following table gives guidance on appropriate tidal volume range using various HMEs
with Adult, Pediatric, and Infant patients.
Patient
Weight
(kg)
VT Range
(ml)
HMEF
Dead Space
Circuit Dead
Space (ml)
Total Dead
Space (ml)
Minimum
VT (ml)
Adult
≥ 40
≥ 400
≤ 75 ml
17 (ped/ adult)
≤ 92
360
Pediatric
12 to 50
120 to 500
≤ 25 ml
17 (ped/ adult)
≤ 42
168
Pediatric
12 to 50
120 to 500
≤ 25 ml
4 (infant/ ped)
≤ 29
117
Infant
5 to 12
50 to 120
≤ 10 ml
4 (infant/ ped)
≤ 14
56
ZOLL does not offer a heated humidifier option for the unit. Users are cautioned to carefully
consider the ramifications of such use and the effect it may have upon device performance and
the patient’s comfort. Such humidifiers have been shown to increase the work of breathing in
portable ventilators4. Any humidification device should be connected and operated only in
accordance with directions provided by its respective manufacturer. Humidifiers are not
recommended for transport. Observe all safety and cautionary statements.
Warning!
Use of the HME or HME/Bacterial Viral filter (HMEF) may not be indicated in patients
with small tidal volumes as the dead space may be greater that 25% of the set Tidal
Volume. Always select an HME/HMEF that is appropriate for the patient. For very
small tidal volumes (50 to 75 ml), it may be advisable to not use an HME.
Warning!
Use of the HME or HME/Bacterial Viral filter (HMEF) will cause a slight increase in
the inspiratory effort to trigger an Assisted Breath (approximately 1 cm H2O).
Warning!
Always monitor the patient and ventilator when using restrictive external filters or the
external O2 reservoir. Changing modes with these restrictions can cause false
compressor failure alarms under parameter configurations where high air flow is
required.
4. Kacmarek et al (Respiratory Care 1990;35:405)
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Hazardous Environment Filters
Hazardous Environment Filters
The unit can be used in environments where chemical and/or biological toxins are present. To
do this safely, all gas delivered to the patient comes from either a pressurized medical-grade
oxygen source and/or filtered ambient air entrained through the Fresh Gas/Emergency Air
Intake. Operators can chose between a bacterial/viral filter and a chemical/biological filter
based on the direction of the Medical Control Officer.
To prevent the patient from breathing contaminated ambient air in the event of a ventilator
failure, the unit contains an internal anti-asphyxia valve that allows the patient to inspire gas
through the external filter. While this design assures that no contaminated gas reaches the
patient, it requires that the operator ensure that nothing blocks the input of the external filter.
Warning!
The Medical Control Officer and/or Incident Commander should determine which, if
any, external filter is used based on the potential hazard.
Warning!
The operator must ensure that nothing blocks the inlet of the external filter; failure to
do so could prevent the patient from breathing and cause an ventilator failure.
Fresh Gas/Emergency Air Intake
Bacterial/Viral Filter
Chemical/Biological Filter
Hazardous Environment Filters
Bacterial/Viral Filter Use
Bacterial/Viral filters (B/V) can be used in environments where the patient is at risk to cross
contamination or airborne pathogens. When used in accordance with the manufacturer’s
instructions, these filters can help prevent inhalation of infectious matter. In dusty
environments, the B/V filters can also be used to prevent entrainment of particulate matter that
could affect the ventilators pneumatic components. To use a bacterial/viral filter, insert the
filter's male 22 mm conical fitting into the Fresh Gas/Emergency Air Intake.
Caution
If filters have been exposed to biological matter, dispose of them following the Universal
Precaution procedures for your facility.
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Chemical/Biological Filter Use
The unit is designed to allow attachment of chemical/biological filter/canister (type C2A15) for
use in contaminated environments. The Fresh Gas/Emergency Air Intake fitting allows for
attachment of standard Rd 40 x 1/7 threads. A complete description of this standard can be
found in BS EN 148-1:1999 Respiratory protective devices - Threads for face pieces.
Check Valve on Breathing Circuit when in Hazardous Environments
When operating in a Hazardous Situation where a chemical/biological filter is in use, the
operator should use a Check Valve (Part #704-0700-01) to prevent hazardous gas from entering
the patient’s breathing circuit. The exhalation valve on the breathing circuit is not adequate to
protect patients if they rapidly inhale/exhale as the valve may not fully close in time to prevent
hazardous gas entrainment. Also, if the PEEP is set low, patients may inhale faster than the flow
is delivered which could cause hazardous gas entrainment. Consequently, a Check Valve is
required to protect patients.
Warning!
The unit is shipped with both the pediatric/adult and infant/pediatric single limb
circuits. A Check Valve (704-0700-01) is required with these breathing circuits when
operating in a hazardous environment. The correct mating of the Check Valve with the
breathing circuit is shown below. Operators who anticipate use in these environments
should also stock the Check Valve.
Check Valve Connection To Breathing Circuit
5. A 3M C2A1 canister (3M St. Paul, MN) was used in our validation testing to represent the class of filters
generically known as C2A1 under the NSN number 4240-01-361-1319. These tests confirmed the
performance of the ventilator when operating with these devices as a class. Use of the 3M canister does not
constitute endorsement or recommendation of the 3M device. Use and selection of the appropriate filter
should always be under the direction of the Incident Commander.
3-12
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906-0731-01 Rev. M
Harsh Environment Operation
Harsh Environment Operation
The unit is designed to operate in harsh prehospital environments and during air and ground
transport. In order to safely manage the patient, the operator must understand the operating
characteristics of the ventilator and diligently monitor the patient and device in these
environments. The unit continuously monitors environmental conditions (temperature and
ambient pressure) and when extreme environments are detected, the operator is alerted by a
Low Priority alarm which defines the operating condition and prompts the actions of the
operator. Low Priority alarms are advisory and the operator should remember that the device is
operating as designed.
Airborne Particulates
Under normal operating conditions, the internal 2-stage filtration system protects the gas flow
path from particulates entrained through the Fresh Gas/Emergency Air Intake. However, when
operating in areas where fine dust or dirt is airborne due to wind or vehicle movement, the
operator should use a disposable bacterial/viral filter (sometimes called HEPA filter) to
preserve the internal filter. Use of these filters will prevent the operator from having to change
the internal filters. For extended operation in these environments, the operator should change
the filter as it becomes dirty (visually inspect the filter for dust/dirt build up). The primary
effect of entrained particles is on the operation of the flow pneumotach used to control the gas
delivered to the patient. Dirt on the pneumotach screens affects the calibration. Cleaning the
screens requires a biomedical technician to disassemble the device and ultrasonically clean the
screens. The best way to prevent taking the unit out of service is to use a filter in dusty
environments. In addition to using the filter, the operator can also keep the unit in the soft case,
which will protect the unit case and the LCD from becoming scratched or damaged. It is also
easier to clean the padded case following use in a dusty/dirty environment than the device.
Extreme Temperature Environments
Traditional transport ventilators typically operate from 0° to 40°C (32° to 104°F). The unit has
been validated by ZOLL to be capable of operating over a range of -25° to 49°C
(-13° to 120°F) and above when required during emergency situations. (The SGS listed
operation range is 10° to 40°C/50° to 104°F.) The primary limit to operating at low or high
temperatures is the performance of commercially available Li ion batteries which limit the
charging temperature to 0° to 45°C (32° to 113°F). However, the batteries have been validated
by ZOLL of being capable of discharging from -25° to 49°C (-13° to 120°F). In addition, the
device has been validated by ZOLL to be capable of operating over the entire range using
external power. When the internal battery temperature drops below 0° or goes above 45°C, a
Low Priority alarm activates, alerting the operator that the battery is no longer charging. This
prevents damage to the Li ion battery from charging at high temperatures, which would void
the battery warranty and create a potential hazard. The battery is still capable of discharging
and powering the unit. Operators can improve temperature performances by making sure that
the unit is in the padded case when operating at low temperatures. The padded case insulates
the unit and allows it to retain the heat generated by the compressor, circuit boards, and AC/DC
Power Supply. When operating at high temperatures, the operator should remove the unit from
the padded case, which allows the unit to pass heat into the surrounding environment.
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ZOLL Portable Critical Care Ventilator Operator’s Guide
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CHAPTER 3 OPERATION
Altitude
The unit is designed to operate from -2,000 to 25,000 feet (-610 to 7620 meters). An absolute
barometric pressure sensor monitors ambient pressure and this information is used to
continuously correct the output of the device to maintain the ventilation parameters. When the
altitude is > 25,000 feet, the unit activates a Low Priority alarm. When this occurs, the operator
should monitor the peak inspiratory pressure (PIP) and adjust the tidal volume to maintain the
PIP and monitor breath sounds and chest excursion to assure adequate ventilation is
maintained. The tidal volume increases as altitude increases, so the operator should look to
prevent over pressurization of the lung when the altitude increases beyond 25,000 feet. If
changes are made above 25,000 feet, the operator should revert to the initial settings once
operation resumes in the compensated range (the LED will turn from yellow to green).
Warning!
The unit is not intended for hyperbaric operation. Use in a hyperbaric chamber can
result in harm to the patient and/or damage to the device.
Rain and Snow
Like any electronic device, the operator should attempt to prevent exposure to rain or snow.
This can be accomplished by using the optional padded case that can be purchased with the
unit. The unit is capable of operating in these conditions if the operator keeps the device in the
padded case and uses the rain flap, which is provided with the padded case. The padded case
and rain flap prevent rain and snow from puddling on any of the device’s surfaces. In cases of
driving rain, where water could possibly enter the unit’s compressor, a bacterial/viral filter can
be used to protect the compressor inlet.
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Use of Low Flow Oxygen
Use of Low Flow Oxygen
Introduction
The unit can use oxygen from low flow sources, oxygen flow meters, and oxygen concentrators
to provide supplemental oxygen to patients. To do this, oxygen is delivered through the Fresh
Gas/Emergency Air Intake when the unit’s internal compressor cycles to deliver a breath. In
order to assure efficient oxygen delivery, ZOLL recommends that the operator use the Oxygen
Reservoir Bag Assembly (Part #704-0004-00). The assembly performs a number of functions.
The Reservoir Bag Assembly
• Acts as a reservoir, collecting oxygen during the expiratory phase of ventilation.
• Provides interference to the ventilator and the attachment of the low-flow oxygen supply
hose.
• Provides an inlet in the event the low-flow oxygen supply fails or the tidal volume is greater
than the supplied oxygen.
Procedure
1. Press the MENU button and use the ROTARY ENCODER to select O2 Reservoir On.
This tells the unit that the reservoir is attached and prevents the FRESH GAS INTAKE
RESTRICTED alarm.
2. Attach the oxygen supply hose to the nipple on the reservoir assembly (see figure below).
3. Attach the O2 Reservoir Bag Assembly to the Fresh Gas/Emergency Air Intake as shown.
Warning!
Always monitor the patient and ventilator when using restrictive external filters or the
external O2 Reservoir. Changing modes with these restrictions can cause false
compressor failure alarms under parameter configuration where high flow is required.
Note:
The assembly will function when the reservoir bag is hanging down or lying
horizontally, provided the bag does not fall in such a way that closes the neck of the
bag.
Note: The ventilator will sound a Low priority FRESH GAS INTAKE RESTRICTED alarm if
the menu has not been changed (see #1 above). Operating with the alarm active does
not affect the ability of the ventilator to deliver breaths at the current settings. It is to
alert the operator that a restriction has been detected at the inlet.
4. Adjust the oxygen flow to achieve an acceptable oxygen saturation.
Note:
Note:
906-0731-01 Rev. M
Always allow 5 to 10 minutes between adjustments to assure the patient oxygenation
has stabilized. This is very important when delivering the oxygen supply where it may
several minutes for a patient to stabilize as the new oxygen flow.
Never use oxygen flows greater than the patient’s consumption. Flows greater than this
may cause the baseline pressure to drift, waste oxygen, and may cause an
INCOMPLETE EXHALATION alarm.
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CHAPTER 3 OPERATION
Operating Notes
Note:
When the reservoir is removed, be sure that the 22 mm adapter is removed with the
assembly.
Due to the slight difference between the densities of air and oxygen, the tidal volume will
decrease slightly as oxygen is entrained. The worst case is a < 10% decrease in tidal volume
when the entrained oxygen results in a FIO2 of 100%. The following tables show both effect on
tidal volume and the resultant FIO2 for various oxygen supply rates:
AC 12, VT 700, PEEP 5, I:E 1:2.5
O2 Flow
l/min
0
1
2
3
4
5
6
7
8
FIO2
21
30
38
48
57
70
80
89
100
VT(set)
740
732
725
718
711
703
691
689
682
VT(actual)
700
692
685
678
671
663
651
649
642
% Chg
0
-1.1
-2.1
-3.1
-4.1
-5.3
-7.0
-7.3
-8.3
AC 12, VT 500, PEEP 5, I:E 1:2.5
O2 Flow
l/min
0
1
2
3
4
5
6
FIO2
21
30
43
56
69
89
100
VT(set)
527
523
514
506
502
493
486
VT(actual)
500
496
487
479
479
466
459
% Chg
0
-0.8
-2.6
-4.2
-5.0
-6.8
-8.2
AC 18, VT 300, PEEP 5, I:E 1:2.5
3-16
O2 Flow
l/min
0
1
2
3
4
5
6
FIO2
21
32
47
62
76
96
100
VT(set)
312
307
303
299
298
291
287
VT(actual)
300
295
291
287
286
279
275
% Chg
0
-1.7
-3.0
-4.3
-4.7
-7.0
-8.3
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Use of Low Flow Oxygen
Oxygen Reservoir Bag Assembly
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ZOLL Portable Critical Care Ventilator Operator’s Guide
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CHAPTER 3 OPERATION
Use In an MRI Environment
You can use ventilator in an MRI environment using a ZOLL MRI Roll Stand with an
Aluminum IV Support Arm. To securely mount the ventilator, tighten the knob on the back
plate of the roll stand to hold the ventilator in position, then lock the roll stand wheels
(we also recommend that you tether the rolling stand in place). See Figure below:
ZOLL Ventilator Mounted On MRI Rolling Stand With IV Support Arm
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Use In an MRI Environment
MRI/Ventilator Hazard Assessment
Warning!
Only ZOLL ventilators marked with an “MRI conditional” label should be used in the
MRI environment.
MR Labels on ZOLL Ventilator
The four main MRI hazard concerns regarding the use of the ZOLL ventilator in an MRI
environment and their remediation are as follows:
Hazard
Hazard Remediation
The static field effects interfere with the
operation of the ventilator.
Operator must place the ventilator behind the
130 Gauss field line (approximately 2 meters to
the bore opening of a 3T MRI magnet).
The ventilator could interfere with the MRI
imaging and introduce image artifacts.
Operator must place the ventilator behind the
130 Gauss field line (approximately 2 meters to
the bore opening of a 3T MRI magnet).
The ventilator, ventilator accessories, and/or cart Operator warned to use proper anchoring and
could feel magnetic attraction and become a
not to stand between bore opening and unit/cart.
projectile missile hazard to both operator and the
patient.
The pulse oximeter can heat up in the MRI
environment due to induced current from the
magnetic field and result in possible burning of
the patient and/or the operator.
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Operator warned not to use the pulse oximeter.
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CHAPTER 3 OPERATION
MRI/Ventilator Warnings
To address the above potential hazards, the following Warnings apply when using the ZOLL
ventilator unit in an MRI environment:
• Only ZOLL ventilators marked with an “MRI conditional” label should be used in the MRI
environment.
• The operator shall follow all safety procedures that are in effect for the MRI environment.
• Failure to follow these ventilator/MRI instructions can result in the malfunction of the
ventilator, MRI artifacts, and/or possible injury to patient/operator.
• The Ventilator shall be placed no closer than the 130 Gauss field line (approximately 2
meters to the bore opening of a 3T MRI magnet).
• The unit should not be used in an MRI environment which has > 3T magnetic strength.
• The unit’s power transformer shall not be brought into the MRI environment. The unit shall
•
•
•
•
•
•
•
•
•
•
•
•
•
•
operate on battery power only. The battery should be fully charged before bringing into the
MRI environment.
The unit’s pulse oximeter cables shall not be brought into the MRI environment.
The unit shall be secured to a ZOLL MRI roll stand (Part #816-0731-01) or properly
secured to another suitable MRI compatible cart prior to entering the MRI environment.
Failure to do so could result in the unit becoming a missile projectile.
The ZOLL MRI roll stand shall be used with the IV arm (aluminum) only
(Part #704-0731-09). It shall not be used with the breathing circuit arm (ferrous). The cart
shall not have any other ferrous materials placed on it due to projectile missile danger.
The operator shall use only aluminum, non-magnetic oxygen cylinders, and oxygen
regulators.
The operator shall not use an active humidifier or humidifier holder/bracket in the MRI
environment. These could become projectile missiles.
At no time shall any person be permitted to be between the bore entrance and an unsecured
unit/roll stand, due to possible missile projectile danger.
When the roll stand is in place, the wheels shall be locked. If possible, it is recommended
that the stand be tethered in position.
The unit/roll stand shall be in place and secured in position before the patient is placed on
the scanner table and advanced into the bore. It is recommended that the unit/roll stand be
tested in the MRI environment prior to its use in patient support. If this is not possible, extra
care must exercised and the unit shall be removed if there is any sign of attractive force with
its potential projectile missile danger.
The patient shall be removed from the MRI environment before the unit/roll stand is
removed from the MRI environment.
The unit’s screen shall be visually monitored for alarms at all times if there is a risk that
audible alarms will not be heard, for example during image acquisition.
The operator shall use only ZOLL MRI breathing circuits
(pediatric/adult Part #820-0130-00, infant/pediatric Part #820-0131-00) or other MRI safe
breathing circuits that will permit suitable separation between the unit and the bore opening
of the magnet.
Extended length of tubing can result in loss of volume due to additional compressibility.
Insure that the patient is receiving correct tidal volume when this circuit is used.
Do not use this circuit with PEEP settings below 5 cm H2O.
Given the additional length of the circuit, the system may not be able to trap PEEP with
patients with short expiratory times. Always assure the device is performing as required
before beginning MRI study.
The longer breathing circuits may affect the required settings of the vent from the settings used
with the shorter breathing circuits in a non-MRI environments.
Caution
3-20
The use of longer breathing circuits may increase the risk of self-triggering of ventilator breaths.
Reducing the pressure trigger sensitivity may solve this problem.
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906-0731-01 Rev. M
Chapter 4
Alarms
The ZOLL Portable Critical Care Ventilator uses Smart Help™ messages that provide a
comprehensive suite of alarms to alert operators and guide their actions to resolve alarm
conditions and assure patient safety. At the onset of an alarm, the screen displays the alarm
name and then a series of context-sensitive Smart Help messages. These Smart Help messages
serve to guide the operator by presenting suggestions as to the cause and resolution of a
particular alarm. When multiple alarms occur they are prioritized and displayed based on the
risk to the patient.
Smart Help Example
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CHAPTER 4 ALARMS
Above is an illustration of what is seen if there are several alarms. The Alarm message refers to
the alarm bell that is dark. The Operator can cycle through the various alarms by turning the
ROTARY ENCODER. If there are less than 5 alarms, this alarm list will also include a “plot”
icon, where the alarm screen will be replaced by the Pulse Pleth/Time and Pressure/Time plots.
If the alarms are Low Priority, then muting these Low Priority alarms will cause the Pleth and
Pressure/Time plots to appear permanently on the screen. If the alarms are Medium Priority,
the unit will cycle through each Medium Priority Alarm for a 20 second period. The ROTARY
ENCODER can be used to select a particular Medium Priority Alarm and/or Plot for 20
seconds, after which the above cycling rotation will resume. New Alarms will overwrite the
screen at any time.
Smart Help Messages
At the onset of an alarm, the Alarm Message Center (AMC) in the upper left-hand corner of the
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 number of active alarms is
indicated at the bottom of the AMC as a series of Alarm Bell icons with each bell indicating an
active alarm. Alarms are prioritized based on the risk to the patient. The alarm with the greatest
risk to the patient is always presented first. All messages are context-based and suggest what is
causing the condition and/or how it can be resolved.
Smart Help Display
4-2
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Smart Help Messages
Smart Help Messages are presented using the following format, based on the image above:
• Alarm Message Center (AMC): Smart Help messages contain the information and
instructions for all active alarms, such as:
a.
b.
c.
d.
e.
f.
Alarm Name/Description: Describes the nature and/or cause of the fault or
failure. The Alarm Name/Description appears at the top of the AMC. When more
than one alarm occurs at the same time, the unit prioritizes them based on patient
safety.
Mitigation/Resolution Instructions: Instructions for the operator as to how the
alarm state may be resolved.
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...**.
Alarm Number Icon: 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 ROTARY ENCODER to scroll through all active alarms. If there are less then
5 alarms, the plot icon will also appear.
Service Code: Each alarm has a 4 digit number associated with it, which helps the
operator communicate with technical assistance or biomedical technician support.
1###: High Priority alarms
2###: Medium Priority alarms
3###: Low Priority alarms
Attention Warning Icon: Identifies the severity of the alarm: Low, Medium, or
High priority.
Alarm Priorities
Alarm priorities define the operational state of the device regarding it ability to provide
mechanical ventilation. The alarm priority determines what effect pressing the
MUTE/CANCEL button will have. There are three priorities:
• High Priority: Mechanical ventilation under operator control is no longer possible. This
alarm category requires immediate intervention by the operator. This includes system failure
alarms where the CPU has failed and a backup has taken over to sound the audible and
visual alarms. It also includes when the device is turned on and there is no internal or
external power source. Pressing the MUTE/CANCEL button has no affect on the High
Priority alarm. The alarm can only be silenced by turning off the ventilator.
• Medium Priority: Mechanical ventilation is active or is possible (maybe for a finite period
of time), but there is a failure/fault with the patient, ventilator circuit, a pneumatic
subsystem, or pulse oximeter. This alarm category requires immediate intervention by the
operator. Pressing the MUTE/CANCEL button mutes Medium Priority alarms for 30
seconds. If after 30 seconds the alarm-causing condition still exists, the audible alarm will
recur until it is muted again for another 30 second period or resolves.
• Low Priority (Advisory): Safe mechanical ventilation is active, but there is a fault that the
operator must be aware of to ensure safe management of the patient and/or ventilator. Low
Priority alarms present with both an audible and yellow LED alarm signal alerting the
operator to the condition. Pressing the MUTE/CANCEL button cancels the audible signal.
If the alarm is not resolved, the yellow LED remains illuminated to remind the operator of
the fault or failure. Some Low Priority alarms may be canceled to avoid nuisance alarms.
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ZOLL Portable Critical Care Ventilator Operator’s Guide
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CHAPTER 4 ALARMS
Ventilator Alarm Categories
Alarms are presented and grouped as categories rather than individual alarms because any
given fault/failure may have a different effect on patient safety based on what operating
resources are available, environmental conditions, and the severity of the fault/failure. In each
case, the unit analyzes the fault/failure and attempts to continue ventilating the patient while
guiding the operator to make an appropriate intervention to resolve the condition.
• CPU Failure: An unrecoverable failure of the central processor unit (CPU) that controls the
user interface and SpO2 monitoring. When this High Priority alarm occurs, the user
interface goes blank and the audible and red LED indicators are active. The backup
ventilation system automatically continues to provide ventilation based on the last good
settings. The alarm can only be silenced by turning the ventilator off.
• Compressor Fault/Failure: Faults or failures with the internal compressor which is used to
deliver electrically powered breaths. High Priority alarms occur when the compressor is no
longer able to deliver breaths based on the ventilator parameters and there is no 55 psig
oxygen supply to operate the O2 Valve as a backup. When a compressor failure occurs with
55 psig oxygen available, the unit automatically begins ventilation using the O2 Valve and
sounds a Medium Priority alarm. To clear the alarm, the operator is required to manually set
the FIO2 to 100%; the Medium Priority alarm changes to a Low Priority alarm, with a
yellow LED and persistent message. Low Priority alarms associated with the compressor
system involve restrictions through the pneumotach screen or internal gas path that are
detected by an internal sensor. Although outside the normal operating conditions, the unit is
still able to deliver breaths within the ventilator parameters.
Note: Failures of the compressor will prevent the entrainment of low flow oxygen
through the Fresh Gas/Emergency Air Intake.
• O2 Valve Fault/Failure: Faults or failures of the O2 Valve which is used to control
pneumatically/oxygen powered breaths. High Priority alarms occur when there is a failure
of the O2 Valve and the internal compressor is not available for backup due to a secondary
failure. When the O2 Valve fails and the FIO2 is > 21%, the unit automatically begins
ventilation using the compressor and sounds a Medium Priority alarm. To clear the alarm,
the operator is required to manually set the FIO2 to 21%; the Medium Priority alarm
changes to a Low Priority alarm, with a yellow LED and persistent message. Low Priority
alarms associated with the O2 Valve involve restrictions through the pneumotach or internal
gas path that are detected by internal sensors. Although outside the normal operating
conditions, the unit is still able to deliver breaths within the ventilator parameters.
• Oxygen Supply Pressure Low Fault/Failure: Faults or failures of the 55 psig oxygen
supply and/or the unit’s ability to detect the presence of high-pressure oxygen. High Priority
alarms occur when the oxygen supply pressure drops below 35 psig and the internal
compressor is not available for backup due to a secondary failure. When the oxygen supply
pressure drops below 35 psig and the FIO2 is > 21%, the unit automatically begins
ventilation using the compressor and sounds a Medium Priority alarm. To clear the alarm,
the oxygen supply pressure must be > 45 psig or the operator must manually set the FIO2 to
21%; the Medium Priority alarm is then canceled.
Note: The operator should recognize that setting the FIO2 to 21% is acknowledging that
the patient is being ventilated without supplemental oxygen. There are no Low
Priority alarms associated with this fault/failure.
• Oxygen Supply Pressure High Fault/Failure: Faults or failures of the 55 psig oxygen
supply and/or the unit’s ability to detect the presence of high-pressure oxygen. High Priority
alarm occurs when the oxygen supply pressure is ≥ 80 psig. When the oxygen supply
pressure is >80 psig, the unit automatically shuts down to prevent harm to the patient and/or
damage to the unit. When the pressure is ≥ 75 and ≤ 80 psig, a Low Priority alarm sounds,
warning the operator of the potential shutdown should pressure increase beyond the current
level.
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Ventilator Alarm Categories
• Fresh Gas Intake Fault/Failure: Obstructions of the Fresh Gas/Emergency Air Intake.
These obstructions can be the result of mechanical blockage of the intake (such as a plastic
bag) or by using an inappropriate filter, when the internal or external filters become dirty or
clogged, or when the low pressure oxygen reservoir is used. The pressure drop across the
intake is continuously monitored. A High Priority alarm occurs when the obstruction
prevents the compressor from delivering a breath that meets the ventilator settings and there
is no 55 psig oxygen supply to operate the O2 Valve as a backup. A Medium Priority alarm
occurs when the obstruction prevents the compressor from delivering a breath that meets the
ventilator settings and there is a 55 psig oxygen supply to operate the O2 Valve as a backup.
Changing FIO2 to 100% will downgrade this alarm to Low Priority. A Low Priority alarm
will occur when the intake is restricted, but the compressor can still deliver a breath that
meets the ventilator settings.
• Power Fault/Failure: Power management and the supply of power from external sources
and the internal rechargable battery. High Priority alarms alert the operator to power failures
where there is no backup power alternative or failures of the internal power management
system. The alarm can only be silenced by turning the ventilator off. Low Priority alarms are
associated with faults or failures that occur where a backup power source is available either
by using the internal battery or through use of the external power source. Pressing the
MUTE/CANCEL button cancels the audible alarm while a persistent message remains.
Note: The unit has the ability to automatically disconnect itself from external power
sources that are providing power outside of the safe power range. When the unit
detects that the external power supply is within range, it automatically reconnects
to the external source to power operation and recharging of the internal battery.
• Low Battery Power: Power remaining in the internal battery and its ability to continue
•
•
•
•
ventilator operation. High Priority alarms signal that the battery no longer has the power to
continue ventilator operation and there is no external source detected. The alarm can only be
silenced by turning the ventilator off. Medium Priority alarms alert the operator that the unit
has approximately 5 minutes of operating time remaining. Pressing the MUTE/CANCEL
button mutes the audible alarm for 30 seconds. The Low Priority alarm occurs during
internal battery operation when the unit determines that there is approximately 30 minutes
of operating time remaining. Pressing the MUTE/CANCEL button cancels the audible
alarm, but the persistent message and yellow LED remain.
Missing Battery: Operating the unit without an internal battery or operation when the
ventilator is not able to detect the internal battery. The Low Priority alarm alerts the operator
that the device is operating on external power and that the unit does not have the ability to
automatically switch to internal battery power in the event of an external power failure.
Pressing the MUTE/CANCEL button cancels the audible alarm, but the persistent message
and yellow LED remain.
SPM Change: Occurs when the CPU does not recognize the smart pneumatic module
(SPM). The failure is most often associated with a mix up during servicing where the
complete unit was not properly calibrated after a new SPM was installed. The alarm can
only be silenced by turning the ventilator off and sending it in for service.
Calibration Fault/Failure: Internal sensors that monitor and control breath delivery. High
Priority alarms occur when there is a failure in one or more of the sensors that prevent the
unit from safely delivering breaths. Medium Priority faults occur when the sensors are not
able to establish an airway pressure baseline. While the unit attempts to recalibrate the
sensor, the audible and visible alarms sound. Pressing the MUTE/CANCEL button mutes
the alarm for 30 seconds.
Exhalation System Fault/Failure: The control of the exhalation valve and airway pressure.
High Priority alarms occur when the airway pressure exceeds the Pressure Limit value or 40
cm H2O for more than 5 seconds, or when the airway pressure is > 75 cm H2O for more than
1.5 seconds. Medium Priority alarms occur when the end expiratory pressure does not reach
the baseline pressure before the start of the next breath. Resolution of this fault is typically
associated with problems causing restrictions to the exhalation valve. Pressing the
MUTE/CANCEL button mutes the audible alarm for 30 seconds.
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ZOLL Portable Critical Care Ventilator Operator’s Guide
4-5
CHAPTER 4 ALARMS
• Airway Pressure High: Triggered when the airway pressure exceeds the High Airway
•
•
•
•
•
•
4-6
Pressure Limit value for two consecutive breaths. Patient related causes for this Medium
Priority alarm are patient coughing, ventilator dissynchrony, or excess secretions in the
airway. Other causes include kinks in the ventilator circuit tubing or a High Airway Pressure
value that is too low given the airway pressure. The default value at start up is 35 cm H2O.
Pressing the MUTE/CANCEL button mutes the audible alarm for 30 seconds.
PEEP Not Met/Leak: Triggered when the ventilator detects a drift of more than 2 cm H2O
in the end expiratory pressure. This Medium Priority alarm is most often associated with a
loose or disconnected circuit hose or tube. The alarm can also be triggered when leaks are
present during noninvasive mask ventilation or when uncuffed endotracheal or
tracheostomy tubes are used. The operator should also check to make sure the exhalation
valve is firmly attached to the circuit and that the cap is securely attached to the body of the
assembly. Pressing the MUTE/CANCEL button mutes the audible alarm for 30 seconds.
Disconnect: Triggered when the peak airway pressure fails to go 5 cm H2O above the
baseline pressure before the end of the inspiratory phase. This Medium Priority alarm is
associated with disconnects between the patient port of the circuit and the patient airway. It
can also be caused by a loose or disconnected circuit hose or tube. Pressing the
MUTE/CANCEL button mutes the audible alarm for 30 seconds.
RTC Battery Fault/Failure: The voltage of the real-time clock (RTC) battery that powers
the memory that stores calibration and service information. The operator should take the
ventilator out of service when appropriate. A Low Priority alarm is sounded when RTC
battery voltage drops below the replacement threshold. Pressing the MUTE/CANCEL
button mutes the audible alarm, but the persistent message and yellow LED remain.
Calibration Due: This Low Priority alarm is triggered when the time since its last
calibration has passed its next due date. Pressing the MUTE/CANCEL button mutes the
audible alarm, but the persistent message and yellow LED remain.
Ambient Pressure Fault: Triggered when the ventilator senses that it is operating outside
of its designed ambient pressure range (-2,000 to 25,000 feet altitude). This Low Priority
alarm alerts the operator that there may be some effect on the delivered volume and to
monitor the airway pressure and breath sounds to assure adequate ventilation of the patient.
Pressing the MUTE/CANCEL button mutes the audible alarm, but the persistent message
and yellow LED remain.
Ambient Temperature Fault: Triggered when the ventilator senses that it is operating
outside of its designed temperature range (-25 to 50°C). This Low Priority alarm alerts the
operator that there may be some effect on the delivered volume and to monitor the airway
pressure and breath sounds to assure adequate ventilation of the patient. Pressing the
MUTE/CANCEL button mutes the audible alarm, but the persistent message and yellow
LED remain.
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906-0731-01 Rev. M
Ventilator Alarm Categories
Pulse Oximeter Alarms
• Low SpO2: Triggered when the SpO2 value drops below the Low SpO2 alarm limit. The
Medium Priority alarm alerts the operator to a decrease in the patient’s oxygenation status.
Resolution of the alarm may involve increasing the FIO2 or suctioning the patient. Pressing
the MUTE/CANCEL button mutes the audible alarm for 30 seconds. The default low alarm
limit at start up is 94%.
• High Heart Rate: Triggered when the heart rate (HR) monitored by the pulse oximeter is
above the High HR alarm limit. The Medium Priority alarm alerts the operator to
bradycardia. Pressing the MUTE/CANCEL button mutes the audible alarm for 30 seconds.
The default high alarm limit at start up is 120 beats/minute.
• Low Heart Rate: Triggered when the heart rate (HR) monitored by the pulse oximeter is
below the Low HR alarm limit. The Medium Priority alarm alerts the operator to
bradycardia. Pressing the MUTE/CANCEL button mutes the audible alarm for 30 seconds.
The default high alarm limit at start up is 40 beats/minute.
• SpO2 Shutdown: Failure of the pulse oximeter. This Medium Priority alarm alerts the
operator to a failure of the pulse oximeter that is nonrecoverable or that communication
between the CPU and pulse oximeter has failed. Pressing the MUTE/CANCEL button
mutes the audible alarm for 30 seconds. In order to suspend the alarm, the operator is
required to use the Menu controls to place SpO2 monitoring in standby (stby). Doing this
cancels the Medium Priority alarm, but the persistent message and yellow LED remain.
• No SpO2 Sensor Connected: Triggered during SpO2 monitoring when the pulse oximeter
does not detect the presence of a functioning SpO2 sensor. This alarm will not occur when
the pulse oximeter is in standby (stby). The Low Priority alarm most often occurs when the
SpO2 sensor cable becomes disconnected from the ventilator. To clear the alarm, reattach
the sensor cable to the ventilator. The alarm can also be suspended, by pressing the
MUTE/CANCEL button, pressing the Menu button, selecting Pulse Oximeter, and setting
the field to standby (stby).
Note: If the unit is started without a pulse oximeter sensor cable attached, pulse oximeter
monitoring does not start and the alarms are not enabled. At any time after start up,
attaching the sensor to the ventilator and patient automatically starts monitoring
and all alarms are enabled.
• Defective SpO2 Sensor: Triggered when the pulse oximeter detects a bad sensor. The Low
•
•
•
•
Priority alarm prompts the operator to check and/or replace the sensor as needed. Pressing
the MUTE/CANCEL alarm cancels the alarm. To clear the alarm, check/replace the sensor
or suspend SpO2 monitoring by placing it in standby (stby).
Low SpO2 Perfusion: Triggered when the pulse waveform is marginal. The Low Priority
alarm alerts the operator to check the sensor site and reposition as needed. Pressing the
MUTE/CANCEL button cancels the alarm. To clear the alarm, check/replace the sensor or
suspend SpO2 monitoring by placing it in standby (stby).
Poor SpO2 Signal: Triggered when the pulse waveform is marginal. The Low Priority
alarm alerts the operator to check the sensor site and reposition as needed. Pressing the
MUTE/CANCEL button cancels the alarm. To clear the alarm, check/replace the sensor or
suspend SpO2 monitoring by placing it in standby (stby).
SpO2 Pulse Search: Triggered whenever the pulse oximeter is not able to detect a pulse
waveform. The Low Priority alarm alerts the operator to check the position of the sensor,
patient movement, and/or the perfusion at the sensor site. Pressing the MUTE/CANCEL
button cancels the alarm. To clear the alarm, reposition the sensor to a better site or suspend
SpO2 monitoring by placing it in standby (stby).
SpO2 Interference Detected: Triggered when the sensor and/or cable are exposed to
significant electromagnetic interference. This Low Priority alarm can be caused by powerful
radio or radar equipment. Pressing the MUTE/CANCEL button cancels the alarm. To clear
the alarm, reposition the sensor to a better site or suspend SpO2 monitoring by placing it in
standby (stby).
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CHAPTER 4 ALARMS
• SpO2 Sensor Off Patient: Triggered when the pulse oximeter detects that it is no longer
connected to the patient. The Medium Priority alarm alerts the operator to check the position
of the sensor, patient movement, and/or the perfusion at the sensor site. Pressing the
MUTE/CANCEL button cancels the alarm. To clear the alarm, reposition the sensor to a
better site or suspend SpO2 monitoring by placing it in standby (stby).
• SpO2 Light Contamination: Triggered when the SpO2 signal is corrupted by an external
light signal. The Low Priority alarm alerts the operator that too much external light
(sunlight, surgical light, etc) is affecting the sensor. Pressing the MUTE/CANCEL button
cancels the alarm. To clear the alarm, shield the sensor from direct light using a cloth or
paper towel.
• Unrecognized SpO2 Sensor: Triggered when the pulse oximeter detects connection with
an inappropriate sensor to the ventilator. The Low Priority alarm alerts the operator that the
attached probe is not designed to work with the pulse oximeter in the ventilator. Pressing the
MUTE/CANCEL button cancels the alarm. To clear the alarm, use an appropriate sensor or
suspend SpO2 monitoring by placing it in standby (stby).
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906-0731-01 Rev. M
731 Series Ventilator Alarms
731 Series Ventilator Alarms
The ZOLL 731 Series Ventilator displays alarms that indicate the following types of alarm
conditions:
• Patient Alarms -- triggered by the actions or condition of the patient
• Device Alarms -- triggered by a malfunction or internal fault with the device
• Environmental Alarms -- triggered by environmental conditions beyond the device’s
operational limits or faults caused by external forces
The following tables list the 731 Series Ventilator’s alarms and provide information about the
alarm:
• Alarm Description -- briefly states the conditions that caused the alarm
• Mitigation Information and Recommended Resolutions -- describes actions to perform
in response to the alarm. Information under “Miltigation/Info” states how to resolve the
alarm, while information within “**...**” are performed when the previous information
does not resolve the alarm.
• Service Code -- four-digit code used to identify each alarm
Patient Alarms
Patient alarms are triggered by the actions or the condition of the patient.
Service Code
Alarm Name/Mitigation/Resolution
2074
High Breath Rate
The actual breathing rate (set rate plus spontaneous patient rate) exceeds the high alarm limit. This
can be caused by the patient breathing too fast due to anxiety or pending respiratory failure. It can
also be caused by autotriggering due to a leak or when the spontaneous/assisted breath trigger is
set too close to the baseline pressure (PEEP).
Mitigation/Info: Check for Loose Hose/Tube, Is Trigger Lever Too Sensitive? Is High Alarm Limit Set
Correctly?
**Consult Physician**
2075
Low Breath Rate/Apnea
The actual breathing rate (set rate plus spontaneous patient rate) is less than the low alarm limit.
Mitigation/Info: Is Patient Breathing Spontaneously?, If Trigger Level Sensitive Enough?, Is Low
Alarm Limit Set Correctly?, Increase Breath Support
**Manually Ventilate Patient**
2076
Apnea
The spontaneous breathing rate is less than the low alarm limit. This alarm only occurs in CPAP
and CPAP-NPPV.
Mitigation/Info: Apnea Backup Ventilation Started, Set Mode to AC or SIMV, Set Rate and Tidal
Volume/Pressure Target
**Manually Ventilate Patient**
2100
Patient Disconnect
The Paw fails to exceed the PEEP setting by ~7 cm H2O.
Mitigation/Info: Check Patient Connection, Check Circuit For Loose Hose/Tube, Check Exhalation
Valve, Patient Breathing With Ventilator?, Replace Circuit
**Manually Ventilate Patient**
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CHAPTER 4 ALARMS
Service Code
Alarm Name/Mitigation/Resolution
2410
Heart Rate High
The heart rate is greater than the High Heart Rate Limit. The default value for the limit is 120 beats/
minute.
Mitigation/Info: Heart Rate Above Limit
**Consult Physician**
2411
Heart Rate Low (Pulse Rate Low)
The heart rate is less than the Low Heart Rate Limit. The default value for the limit is 40 beats/
minute.
Mitigation/Info: Heart Rate Below Limit
**Consult Physician**
3091
Incomplete Exhalation
The exhaled flow from the patient continues throughout the expiratory period causing the expiratory
control valve to cycle throughout the period to maintain the baseline pressure.
Mitigation/Info: Incomplete Exhalation, Increase Expiratory Time, Decrease Inspiratory Time,
Decrease Respiratory Rate
**Consult Physician**
3092
Patient Inspiratory Demand Not Met
The end Inspiratory Paw is < -1.0 cm H2O for 3 consecutive breaths. (3 breaths are required to
eliminate nuisance alarms when the patient takes a single deep breath.) This can occur due to
changes in the patient’s status, where the patient will attempt to inspire more gas than what is
currently being delivered.
Mitigation/Info: Patient Breathing/Fighting with Vent?, Increase Flow Rate or Reduce Rise Time,
Adjust Alarm Settings if Required, Consult Physician
**Manually Ventilate Patient**
3313
SpO2 Signal Interference
An outside signal or energy source prevents accurate reading by the device.
Mitigation/Info: External Signal Interfering With Measurement, Remove Patient from Location
**Turn Off Pulse Ox Monitoring**
3317
Low SpO2 Perfusion (Low Perfusion)
The amplitude of the arterial pulsation is weak. Low perfusion typically occurs in patients with poor
circulation or when the sensor is applied to the same limb as the noninvasive blood pressure
(NIBP) cuff.
Mitigation/Info: Arterial Pulsation Weak, Check Sensor Placement, Check Sensor Operation
**Turn Off Pulse Ox Monitoring**
3318
Low SpO2 Perfusion (Poor SpO2 Signal)
The pulse oximeter determines the quality of the input signal is low due to excessive motion or
artifact.
Mitigation/Info: Signal Artifact, Minimize Patient Movement, Check Sensor Placement, Check
Sensor Operation
**Turn Off Pulse Ox Monitoring**
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906-0731-01 Rev. M
731 Series Ventilator Alarms
Device Alarms
Device alarms are triggered by a malfunction or internal fault with the ventilator device.
Service Code
Alarm Name/Mitigation/Resolution
1001
Compressor Failure (Compressor Control Fault - No Backup)
The compressor fails to operate or fails to provide the flow required to deliver a breath and
high-pressure oxygen (HP O2) is not available to provide ventilation.
Mitigation/Info: Manually Ventilate Patient, Connect HP O2, Restart Ventilator With HP O2
**Replace/Service Ventilator**
1002
Compressor Failure (Compressor Signal Chain Fault - No Backup)
Communication between the compressor controller and Smart Pneumatic Module (SPM) is lost and
high-pressure oxygen (HP O2) is not available to provide ventilation.
Mitigation/Info: Manually Ventilate Patient, Connect HP O2, Restart Ventilator With HP O2
**Replace/Service Ventilator**
1003
Self Check Failure
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 operator.
Mitigation/Info: Manually Ventilate Patient
**Replace/Service Ventilator**
1010
O2 Valve Failure (O2 Valve Failed Open)
The O2 Valve fails in the open position which results in continuous inspiratory flow. When this
occurs, the unit automatically opens the exhalation valve to prevent pressure from accumulating in
the circuit and ventilation stops.
Mitigation/Info: Manually Ventilate Patient
**Replace/Service Ventilator**
1011
O2 Valve Failure (O2 Valve Control Fault - No Back Up)
The signal to the O2 Valve is not delivering the required flow rate and the compressor is not
available to provide ventilation.
Mitigation/Info: Manually Ventilate Patient
**Replace/Service Ventilator**
1012
O2 Valve Failure (O2 Valve Signal Chain Fault - No Back Up)
The communication between the O2 Valve and the SPM fails and the compressor is not available to
provide ventilation.
Mitigation/Info: Manually Ventilate Patient
**Replace/Service Ventilator**
1020
O2 Supply Pressure Low
The oxygen supply pressure is ≤ 35 psig and the compressor is not available to support ventilation.
If the oxygen source can be restored, the unit should be cycled off then on to reset. By design, the
unit will not reestablish oxygen operation unless the supply pressure is ≥ 40 psig.
Mitigation/Info: Manually Ventilate Patient, Connect 55 psig O2 then Restart, Check O2 Supply for
Leaks,Replace Regulator
**Replace/Service Ventilator**
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CHAPTER 4 ALARMS
Service Code
Alarm Name/Mitigation/Resolution
1041
O2 Supply Pressure High
The oxygen supply is >80 psig. Pressures above 80 psig could result in a catastrophic failure, harm
to the patient and/or damage to the unit.
Mitigation/Info: Manually Ventilate Patient, Decrease O2 Supply to 55 psig, Replace Regulator,
Connect Low Flow O2
**Restart Ventilator without O2 Supply**
1051
Run-Time Calibration Failure
There is a failure of the calibration system.
Mitigation/Info: Manually Ventilate Patient
**Replace/Service Ventilator**
1052
Airway Pressure Sensing Failure
Communication between the airway pressure sensor and SPM is lost.
Mitigation/Info: Manually Ventilate Patient
**Replace/Service Ventilator**
1061
Exhalation System Failure (Excessive Airway Pressure)
The airway pressure (Paw) is above 40 cm H2O, the PIP High Limit (when PIP High Limit is <35 cm
H2O) for >5 seconds, or when the Paw is above 75 cm H2O for >1.5 seconds. When this happens,
the unit stops ventilating and attempts to discharge the pressure in the breathing circuit to
atmosphere.
Mitigation/Info: Manually Ventilate Patient, Replace Circuit and Restart
**Replace/Service Ventilator**
1061
Exhalation System Failure (Excessive Airway Pressure)
The airway pressure (Paw) is above 40 cm H2O, the PIP High Limit (when PIP High Limit is <35 cm
H2O) for >5 seconds, or when the Paw is above 75 cm H2O for >1.5 seconds. When this happens,
the unit stops ventilating and attempts to discharge the pressure in the breathing circuit to
atmosphere.
Mitigation/Info: Manually Ventilate Patient, Replace Circuit and Restart
**Replace/Service Ventilator**
1172
5 Volt Self Check Failure
The 5 volt power bus fails to provide the required voltage.
Mitigation/Info: Manually Ventilate Patient, Ventilator Not Functioning
**Replace/Service Ventilator**
1173
Internal Communication Failure (Host Device Communication Failure)
Communication fails between one of the subcomponents and the hose processor.
Mitigation/Info: Manually Ventilate Patient, Backup Ventilator Enabled
**Replace/Service Ventilator**
1174
Off Set Self Check Failure
The device is not able to calibrate the one or more transducers and is no longer able to operate
safely.
Mitigation/Info: Manually Ventilate Patient, Ventilator Not Functioning
**Replace/Service Ventilator**
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906-0731-01 Rev. M
731 Series Ventilator Alarms
Service Code
Alarm Name/Mitigation/Resolution
1175
Internal Communication Failure
There is a failure of the internal communication bus and the host is not able to communicate with
the subassemblies.
Mitigation/Info: Manually Ventilate Patient, Ventilator Not Functioning
**Replace/Service Ventilator**
1176
Off Set Self Check Failure
The calibration file fails its integrity check.
Mitigation/Info: Manually Ventilate Patient, Ventilator Not Functioning
**Replace/Service Ventilator**
1420
Complete Power Failure
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 for approximately two minutes.
Mitigation/Info: No LCD Display
1430
Empty Battery
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 operator.
Mitigation/Info: Manually Ventilate Patient, Connect to External Power, Restart Ventilator
**Replace/Service Ventilator**
1471
Internal Communication Failure
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.
Mitigation/Info: Manually Ventilate Patient, Backup Ventilator Enabled
**Replace/Service Ventilator**
1472
Internal Communication Failure
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.
Mitigation/Info: Manually Ventilate Patient, Backup Ventilator Enabled
**Replace/Service Ventilator**
1473
Internal Communication Failure
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.
Mitigation/Info: Manually Ventilate Patient, Backup Ventilator Enabled
**Replace/Service Ventilator**
1475
LCD Control Failure
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 settings and the High Priority alarm sounds.
Mitigation/Info: Manually Ventilate Patient, Backup Ventilator Enabled
**Replace/Service Ventilator**
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CHAPTER 4 ALARMS
Service Code
Alarm Name/Mitigation/Resolution
1480
SPM Compatibility Failure
The unit and SPM software loads are not compatible. This alarm is typically associated with an
SPM change where the technician failed to update the unit and SPM to the current software
revision. Ventilation is provided using the backup mode settings.
Mitigation/Info: Manually Ventilate Patient, Software Compatibility Failure
**Replace/Service Ventilator**
1485
Power-On Self Check Failure
The Smart Pneumatic Module (SPM) software fails and is shut down. Powering the unit off allows
the software to reset and may allow operation to continue.
Mitigation/Info: Manually Ventilate Patient, Abnormal Reset Detected, Restart Ventilator
**Replace/Service Ventilator**
2001
Compressor Fault
The communication between the compressor and the SPM fails and HP O2 is available to provide
ventilation.
Mitigation/Info: Operation Switched to O2 valve, Set FIO2 to 100%
**Replace/Service Ventilator**
2002
Compressor Fault
The communication between the compressor controller and the SPM is lost and HP O2 is available
to provide ventilation.
Mitigation/Info: Operation Switched to O2 valve, Set FIO2 to 100%
**Replace/Service Ventilator**
2011
O2 Valve Fault
The signal to the O2 Valve is outside of the calibration range for the required flow rate and the
compressor is available to provide ventilation.
Mitigation/Info: Operation Switched to Compressor, Set FIO2 to 21%, Connect Low Flow O2,
Monitor SpO2
**Replace/Service Ventilator**
2012
O2 Valve Fault
The communication between the O2 Valve and the SPM fails and the compressor is available to
provide ventilation.
Mitigation/Info: Operation Switched to Compressor, Set FIO2 to 21%, Connect Low Flow O2,
Monitor SpO2
**Replace/Service Ventilator**
2020
O2 Valve Fault
The oxygen supply pressure is <35 psig and the compressor is available to provide ventilation.
Note: The device is designed to work with or without external oxygen. If HP O2 is connected, the
unit will not continue oxygen operation unless the supply pressure is ³ 40 psig. This is done
to prevent continuous cycling between alarms during the inspiratory phase and not alarm
during expiratory phases. If low flow oxygen is available, it can be entrained through the
Fresh Gas/Emergency Air Intake using the optional O2 Reservoir. Maintain an acceptable
SpO2 by adjusting the oxygen supply up or down to increase or decrease the amount of
oxygen delivered to the patient.
Mitigation/Info: Operation Switched to Compressor, Check O2 Supply Pressure, Check/Replace
Regulator, Set FIO2 to 21%, Connect Low Flow O2, Monitor SpO2
**Replace/Service Ventilator**
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906-0731-01 Rev. M
731 Series Ventilator Alarms
Service Code
Alarm Name/Mitigation/Resolution
2053
Suspicious Triggers
Airway pressure sensor fails to calibrate the expiratory phase of a breath. When this occurs, the
unit attempts to reestablish a baseline by momentarily setting PEEP to 0 cm H2O and suspending
triggered breaths. This interruption lasts no longer than 2 breath cycles.
Mitigation/Info: Attempted Self-Calibration, Momentarily Disabling Triggers and PEEP, Check
Circuit for Leak/Disconnects, Check Tube Placement/Cuff
**Replace/Service Ventilator**
2062
Exhalation Fault
The airway pressure (Paw) measured at the end of expiration is >5 cm H2O above the baseline
pressure (PEEP pressure).
Mitigation/Info: Check Circuit for Kinked Hose/Tube, Check for Blocked Exhalation Valve, Replace
Circuit, Replace/Service Ventilator
**Manually Ventilate Patient**
2070
Airway Pressure High
The Paw meets or is greater than the High Airway Pressure Limit for 2 consecutive breaths. When
this occurs, flow decelerates to maintain Paw at the High Airway Pressure Limit for the duration of
the breath (inspiratory time).
Mitigation/Info: Pressure Exceeds Limit Setting, Check Circuit for Kinked Hose/Tube, Check for
Airway Obstructions, Suction Airway if Necessary, PIP High Limit Set Too Low?
**Manually Ventilate Patient**
2071
Low Airway Pressure
The Paw is less than the Low Airway Pressure Limit for 2 consecutive breaths..
Mitigation/Info: Check Patient Connection, Check Circuit for Loose Hose/Tube, Check Exhalation
Valve, Check Tube Placement/Cuff, Is High Limit Set Correctly?
**Manually Ventilate Patient**
2072
High Tidal Volume
Operating with a pressure target and the delivered tidal volume exceeds the operator defined limit
for 2 consecutive breaths.
Mitigation/Info: Check Patient Connection, Check Circuit for Loose Hose/Tube, Check Exhalation
Valve, Check Tube Placement/Cuff, Is High Limit Set Correctly?
**Monitor Patient**
2073
Low Tidal Volume
Operating with a pressure target and the delivered tidal volume does not reach the operator defined
limit for 2 consecutive breaths. When this occurs, flow decelerates to maintain the Paw at airway
pressure limit for the duration of the breath (inspiratory time). If the PIP setting is set properly, the
breath should be greater than the low limit (provided it is set properly as well).
Mitigation/Info: Check Circuit for Kinked Hose/Tube, Check For Airway Obstruction, Suction Airway
If Necessary, If Low Limit Set Correctly?
**Manually Ventilate Patient**
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CHAPTER 4 ALARMS
Service Code
Alarm Name/Mitigation/Resolution
2090
PEEP Not Met/Circuit Leak
Paw drops below the PEEP setting by 2 cm H2O during the expiratory phase of the breath. This can
be caused by a leak in the breathing circuit, exhalation valve, or patient airway..
Mitigation/Info: Check Patient Connection, Check Circuit For Loose Hose/Tube, Check Exhalation
Valve, Check Tube Placement/Cuff
**Replace Circuit**
2095
Insufficient Flow
The pressure target is not reached during the inspiratory period during pressure targeted
ventilation. Typically, this can occur when the Rise Time is set too low for the patient and their
respiratory mechanics.
Mitigation/Info: Pressure Target Not Met, Decrease Rise Time, Press/Hold BPM Button
**Ventilate With Volume Target**
2170
Spontaneous Breath-PIP High
The Paw exceeds the High PIP Limit setting during 2 consecutive spontaneous breaths.
Mitigation/Info: Pressure Exceeds Limit Setting, Check Circuit for Kinked Hose/Tube, Check for
Airway Obstruction, Suction Airway If Necessary, PIP High Limit Set Too Low?
**Manually Ventilate Patient**
2171
Spontaneous Breath-PIP Low
The Paw exceeds the Low PIP Limit setting during 2 consecutive spontaneous breaths.
Mitigation/Info: Check Circuit for Loose Hose/Tube, Check Exhalation Valve, Check Tube
Placement/Cuff, Is Low Limit Set Correctly?
**Manually Ventilate Patient**
2172
Spontaneous Breath-VT High
The High VT Limit is exceeded during 2 consecutive spontaneous breaths.
Mitigation/Info: Check Circuit for Loose Hose/Tube, Check Exhalation Valve, Check Tube
Placement/Cuff, Is High Limit Set Correctly?
**Manually Ventilate Patient**
2173
Spontaneous Breath-VT Low
The Low VT Limit is not achieved during 2 consecutive spontaneous breaths.
Mitigation/Info: Check Circuit for Kinked Hose/Tube, Check For Airway Obstruction, Suction Airway
If Necessary, Is Low Limit Set Correctly?
**Manually Ventilate Patient**
2300
Pulse Ox Module Failed
The pulse oximeter module fails while in use. There is no operator intervention. When the alarm is
active, “-- --” will display in the HR and SpO2 windows.
Mitigation/Info: Internal Failure, SpO2/HR Not Available, Turn Off Pulse Ox
**Replace/Service Ventilator**
2301
Internal Communication Failed
The communication between the pulse oximeter and the unit fails.
Mitigation/Info: Pulse Ox Module Failure, SpO2/HR Not Available, Turn Off Pulse Ox
**Replace/Service Ventilator**
4-16
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906-0731-01 Rev. M
731 Series Ventilator Alarms
Service Code
Alarm Name/Mitigation/Resolution
2401
SpO2 Low
The SpO2 value drops below the Low SpO2 Limit. The default value for the limit is 94%.
Mitigation/Info: SpO2 Below Limit, Increase FIO2, Check O2 Supply, Increase PEEP Per Physician
**Consult Physician**
2421
Input Protection Circuit Failed
There is a failure of the input protection circuit and the unit is able to operate.
Mitigation/Info: Input Protection Circuit Failure, Power System Needs Repair, Internal Battery
Operation
**Replace/Service Ventilator**
2423
Power Circuit Hardware Fault
The internal power circuit has failed and external power is connected but cannot be used. The fault
cannot be repaired by the operator.
Mitigation/Info: Power System Needs Repair, Internal Battery Operation
**Replace/Service Ventilator**
2430
Low Battery
The unit detects that there is ≤5 minutes of battery operation remaining and external power is not
connected.
Mitigation/Info: Less Than 5 Minutes Operation, Connect External Power, Assure Ability to
Manually Ventilate
**Replace/Service Ventilator**
2455
Battery Fault-No External Power Connected
The unit is not able to communicate with the internal battery. When this occurs, the device does not
know the current charge in the battery and operation could stop at any time.
Mitigation/Info: Battery Communication Failure!, Connect External Power, Assure Ability to
Manually Ventilate Patient
**Replace/Service Ventilator**
3001
Compressor Fault
The compressor fails to operate or fails to provide the flow required to deliver a breath within ±10%
of the current settings, HP O2 is available to provide ventilation and the operator has set the FIO2
to 100%.
Mitigation/Info: Assure 55 psig O2, O2 Operation Only!
**Replace/Service Ventilator**
3002
Compressor Fault
Communication between the compressor controller and SPM is lost, HP O2 is available to provide
ventilation, and the operator has set the FIO2 to 100%.
Mitigation/Info: Assure 55 psig O2, O2 Operation Only!
**Replace/Service Ventilator**
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ZOLL Portable Critical Care Ventilator Operator’s Guide
4-17
CHAPTER 4 ALARMS
Service Code
Alarm Name/Mitigation/Resolution
3011
O2 Valve Fault
The signal to the O2 valve is outside of the calibration range for the required flow rate, the
compressor is available to provide ventilation, and the operator has acknowledged that ventilation
is being provided using the compressor by setting the FIO2 to 21%.
Mitigation/Info: Compressor Operation Only!, Keep FIO2 at 21%, Connect Low Flow O2, Monitor
SpO2
**Replace/Service Ventilator**
3012
O2 Valve Fault
Communication between the O2 Valve is lost, the compressor is available is available to provide
ventilation, and the operator has set the FIO2 to 21%.
Mitigation/Info: Operation Switched to Compressor!, Keep FIO2 at 21%, Connect Low Flow O2,
Monitor SpO2
**Replace/Service Ventilator**
3032
Fresh Gas Intake Fault
Communication between the Fresh Gas/Emergency Air Intake pressure sensor is lost. Normal
operation will continue, but if the condition is not cleared by powering off and restarting, the unit
should be send for service. When used during this alarm condition, the operator should be sure to
keep the Fresh Gas/Emergency Air Intake clear and assure that external filters are checked
regularly.
Mitigation/Info: Intake Pressure Sensor Failure, Unable to Detect Filter Obstruction
**Replace/Service Ventilator**
3041
O2 Supply Pressure High
The oxygen supply pressure is ≥75 psig and < 80 psig. The alarm automatically cancels when the
supply pressure drops below 66 psig. Pressures above 80 psig could result in a catastrophic failure,
harm to the patient, and/or damage to the unit.
Mitigation/Info: Decrease O2 Supply Pressure, Replace Regulator, Connect Low Flow O2, Monitor
SpO2
**Monitor O2 Supply Pressure**
3110
RTC Battery Fault
The real-time clock (RTC) battery is < ~2.5 volts.
Mitigation/Info: RTC Battery Low, Schedule Service Immediately
**Replace/Service Ventilator**
3120
Self Check Fault
Start up when the preselected number of days has elapsed from the last calibration. Calibration is
due every 365 days or 1500 hours of service.
Mitigation/Info: Calibration Due, Schedule Service Immediately
**Replace/Service Ventilator**
3130
Ambient Pressure Fault (Excessive Altitude Sensor Failure)
The ambient pressure transducer fails. When this occurs, the unit is no longer able to automatically
compensate for changes in altitude especially in situations where the ambient pressure could
change rapidly as during air transport.
Mitigation/Info: Barometric Pressure Sensor, Altitude Compensation Disable, Maintain Airway
Pressure, Check Patient Chest Rise, Avoid Use At Varying Altitude
**Replace/Service Ventilator**
4-18
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906-0731-01 Rev. M
731 Series Ventilator Alarms
Service Code
Alarm Name/Mitigation/Resolution
3143
Self Check Fault
The failure of the internal temperature sensors. When this occurs, the unit is no longer able to
detect if it is operating outside the allowable temperature range.
Mitigation/Info: Temperature Sensor Fault, Temperature Changes Do Not Affect Autocal Cycle,
Schedule Service Immediately
**Replace/Service Ventilator**
3300
SpO2 Shutdown (MS 11 Failure-Monitor Not In Use)
The pulse oximeter module fails and the operator has turned off pulse oximeter monitoring
acknowledging the condition.
Mitigation/Info: Internal Failure, SpO2.HR Not Available
**Replace/Service Ventilator**
3301
SpO2 Shutdown (Communication Failure EMC-Pulse Ox-Monitor Not In Use)
Communication between the pulse oximeter module and the unit fails and the operator has turned
off pulse oximeter monitoring acknowledging the condition.
Mitigation/Info: Pulse Oximeter Failure, SpO2.HR Not Available
**Replace/Service Ventilator**
3310
No SpO2 Sensor Connected (No Sensor Connected)
The pulse oximeter detects that no SpO2 sensor is connected after a period of successful
operation.
Note: During start up, the unit automatically detects if a sensor is connected. If it is, the unit begins
operation with the pulse oximeter active. If no sensor is detected, the unit turns off this
function.
Mitigation/Info: Check Pulse Ox Sensor, Check Sensor/Ventilator Connection, Reinsert Sensor,
Cable/Sensor Damaged?, Replace Sensor
**Turn Off Pulse Ox Monitoring**
3311
Defective Sensor
The pulse oximeter cannot identify the connected sensor or the sensor has failed. Cause for this
alarm include broken sensor cable, inoperative LEDs and/or faulty detector.
Mitigation/Info: Check Pulse Ox Sensor, Check Sensor/Ventilator Connection, Reinsert Sensor,
Cable/Sensor Damaged?, Replace Sensor
**Turn Off Pulse Ox Monitoring**
3312
SpO2 Pulse Search
The pulse oximeter is searching for a pulse. If values are not displayed within 30 seconds,
disconnect and reconnect the sensor and reapply to the patient. If pulse search continues, remove
the sensor and replace on a better perfused site. Replace the sensor if another sensor is available
Mitigation/Info: Please Wait, Check Sensor Placement, Change Placement, Minimize Patient
Movement, Check Sensor Operation/Replace
**Turn Off Pulse Ox Monitoring**
3316
Invalid SpO2 Sensor (Unrecognized Sensor)
The pulse oximeter does not recognize the connected sensor. The alarm can also occur when there
is a broken sensor cable, inoperative LEDs, a fault is detected, and/or the sensor has failed.
Mitigation/Info: Invalid Pulse Ox Sensor, Replace Sensor
**Turn Off Pulse Ox Monitoring**
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ZOLL Portable Critical Care Ventilator Operator’s Guide
4-19
CHAPTER 4 ALARMS
Service Code
Alarm Name/Mitigation/Resolution
3421
External Power Fail/Disconnect
The external power (either AC or DC) drops below minimum level (~11 VDC as supplied by either
the AC/DC Power Supply or a direct DC source) or power is intentionally disconnected.
Mitigation/Info: Internal Battery Operation, Check Power Connection/Supply, Monitor Battery Status
**Replace/Service Ventilator**
3422
Missing Battery
The internal battery is removed or communication between the battery and CPU has failed. When
external power is applied, the unit is capable of operation; however, loss of external power will
result in loss of ventilation and a High Priority alarm. Operating in this state should only be done
when no other alternatives are available.
Mitigation/Info: No Battery Detected, DO NOT Remove External Power!, Maintain External Power!
**Replace/Service Ventilator**
3423
Battery Charge Circuit Failed
The Battery Charge Circuit has failed. Under this condition, the battery cannot be charged.
Mitigation/Info: Power System Needs Repair, Battery Cannot Charge, Maintain External Power!
**Replace/Service Ventilator**
3430
Low Battery (Low Battery-Warning)
The unit detects that there are ≤30 minutes of battery operation remaining and no external power is
connected.
Mitigation/Info: Less Than 30 Minutes Operation, Connect External Power, Assure Ability to
Manually Ventilate
**Replace/Service Ventilator**
3431
Low Battery
External power is connected to a unit that has an internal battery that has drained to a Low Battery
status.
Mitigation/Info: Less Than 30 Minutes Internal Backup, Operating With External Power, Continue
Charging With External Power, Assure Ability to Manually Ventilate
**Replace/Service Ventilator**
3441
External Power Failed (External Voltage High)
The supplied DC power is >33 VDC. When this occurs, the unit automatically switches to operation
using the internal battery. If the supplied voltage drops to <30 VDC, the unit automatically switches
to operation using external power.
Mitigation/Info: External Voltage Too High, Internal Battery Operation, Check/Replace Power
Supply
**Remove DC Connection**
3442
External Power Failed (Insufficient Current)
The external power supply has insufficient current. When this occurs, the unit automatically
switches to operation using the internal battery.
Mitigation/Info: Internal Battery Operation, Check/Replace Power Supply, Change Power Source
**Remove DC Connection**
4-20
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906-0731-01 Rev. M
731 Series Ventilator Alarms
Service Code
Alarm Name/Mitigation/Resolution
3444
External Power Failed
The voltage polarity is reversed when the unit is attached to an external DC source. When this
occurs, the unit automatically switches to operation using the internal battery.
Mitigation/Info: DC Voltage Reversed, Internal Battery Operation, Disconnect Power Source
**Replace Power Source**
3455
Battery Fault-With External Power Connected (Battery Communication Failure)
The unit is not able to communicate with the internal battery and external power is connected.
Mitigation/Info: Battery Communication Failure!, DO NOT Remove External Power!, Assure Ability
to Manually Ventilate Patient
**Replace Battery Soon**
3470
Internal Communication (Comm) Failure Fault-PIM Comm
The unit is no longer able to communicate with the Power Interface Module (PIM).
Mitigation/Info: Power Management Failure, Assure Ability To Manually Ventilate Patient, Monitor
Power Source
**Replace/Service Ventilator**
3480
SPM Compatibility Fault
The unit software detects that it has not been calibrated with the SPM that is inside the unit. This
fault occurs when the biomedical technician fails to recalibrate the unit following an SPM change or
service.
Mitigation/Info: Hardware Compatibility Failure, Update Calibration Records
**Replace/Service Ventilator**
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ZOLL Portable Critical Care Ventilator Operator’s Guide
4-21
CHAPTER 4 ALARMS
Environmental Alarms
Environmental alarms are triggered by environmental conditions beyond the device’s
operational limits or faults caused by outside forces.
Service Code
Alarm Name/Mitigation/Resolution
1060
Exhalation System Failure (Exhalation Valve Failure)
The exhalation control valve fails to operate. When this happens, the unit 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.
Mitigation/Info: Manually Ventilate Patient, Replace Circuit and Restart
**Replace/Service Ventilator**
2030
Fresh Gas Intake Fault
The Fresh Gas/Emergency Air Intake is blocked so that the compressor is not able to deliver a
breath within ±10% of the current settings and HP O2 is available to support ventilation.
Mitigation/Info: Operation Switched to O2 Valve, Clear Blocked Intake, Set FIO2 to 100%, Monitor
SpO2
**Replace/Service Ventilator**
2450
Battery Fault-No External Power Connected
The battery temperature reaches 70°C (158°F), which is 5°C from its maximum operating
temperature using the internal battery and external power is not connected. When the battery
temperature reaches 75°C (167°F), the battery will shut down to prevent failure and the unit will
sound a High Priority alarm and shutdown.
Mitigation/Info: Battery Within 5°C of High Limit, Remove Padded Case, Assure External Power
Available, Assure Ability to Manually Ventilate, Shade Patient and Ventilator
**Move to Cooler Location**
3030
Fresh Gas Intake Fault
The Fresh Gas/Emergency Air Intake is blocked so that the compressor is not able to deliver
breaths within 10% of the current settings, HP O2 is available to support ventilation, and the
operator has set the FIO2 to 100%.
Mitigation/Info: O2 Valve Operation, Clear Blocked Intake & Retry Compressor, Keep FIO2 at 100%,
Monitor SpO2
**Replace/Service Ventilator**
3031
Fresh Gas Intake Fault
The Fresh Gas/Emergency Air Intake is blocked but is still capable of delivering breaths within 10%
of the current settings. This could be caused by an external blockage or a dirty external or internal
filter.
Mitigation/Info: Clear Restricted Intake, Patient Breathing with Ventilator?
**Replace/Service Ventilator**
3131
Ambient Pressure Fault (Excessive Altitude)
The ambient pressure transducer detects an altitude >25,000 feet (7620 meters). Beyond this
altitude, compensation remains fixed at the 25,000 ft compensation level.
Mitigation/Info: Excessive Altitude Detected, Beyond Altitude Compensation Limit, Maintain Airway
Pressure, Check Patient Chest Rise, Monitor Ventilator/Patient
**Reduce Altitude**
4-22
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906-0731-01 Rev. M
731 Series Ventilator Alarms
Service Code
Alarm Name/Mitigation/Resolution
3132
Ambient Pressure Fault
The ambient pressure transducer detects an altitude of <-2,000 feet below sea level (610 meters,
15.8 psig, or 1089 mb). This state can be caused by use in subterranean rescue operations or
mistaken use in a hyperbaric chamber. Beyond this pressure level, compensation remains fixed at
the -2,000 ft level
Note: The unit is not intended for use in hyperbaric chambers
Mitigation/Info: High Barometric Pressure Detected, Beyond Compensation Limit, Maintain Airway
Pressure, Check Patient Chest Rise, Monitor Ventilator/Patient
**Reduce Ambient Pressure**
3140
Operational Temperature Fault (Excessive Temperature High)
The ambient temperature exceeds the normal operating range (>131°F, 55°C) for the ventilator.
The unit allows operation at these temperatures, but alerts the operator to the condition. Operating
above the specified range can affect the longevity of the internal battery and the duration of
operating time.
Mitigation/Info: High Temperature Detected, Remove Padded Case
**Monitor Ventilator**
3141
Operational Temperature Fault (Excessive Temperature Low)
The ambient temperature exceeds the normal operating range (<14°F, -10°C) for the ventilator.
The unit allows operation at these temperatures, but alerts the operator to the condition. Operating
above the specified range can affect the longevity of the internal battery and the duration of
operating time.
Mitigation/Info: Low Temperature Detected, Use Padded Case
**Monitor Ventilator**
3315
Too Much Ambient Light
There is too much ambient light on the SpO2 sensor or there is inadequate tissue covering the
sensor detector.
Mitigation/Info: Shield Sensor From Light, Change Sensor Placement, Check Sensor Operation,
Replace Sensor
**Turn Off Pulse Ox Monitoring**
3450
Battery Fault (Battery Nearly Too Hot For Discharge-w/External Power Connected)
The battery temperature reaches 70°C (158°F), which is 5°C from its maximum operating
temperature and external power is connected. When the battery temperature reaches 75°C
(167°F), the battery will shut down to prevent failure. When this occurs, the unit will continue
operation using external power only.
Mitigation/Info: Battery Too Hot to Discharge, DO NOT Remove External Power!, Remove Padded
Case, Assure Ability to Manually Ventilate Patient, Shade Patient and Ventilator
**Move to Cooler Location**
3451
Battery Fault (Battery Too Hot For Discharge-w/External Power Connected)
The battery temperature reaches ≥75°C (167°F) and external power is connected. Discharging the
battery beyond this temperature could destroy the battery and damage the unit. During the alarm
condition, the unit will continue operation using external power only.
Mitigation/Info: Battery Too Hot to Discharge, DO NOT Remove External Power!, Remove Padded
Case, Assure Ability to Manually Ventilate Patient, Shade Patient and Ventilator
**Move to Cooler Location**
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ZOLL Portable Critical Care Ventilator Operator’s Guide
4-23
CHAPTER 4 ALARMS
Service Code
Alarm Name/Mitigation/Resolution
1060
Exhalation System Failure (Exhalation Valve Failure)
The exhalation control valve fails to operate. When this happens, the unit 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.
Mitigation/Info: Manually Ventilate Patient, Replace Circuit and Restart
**Replace/Service Ventilator**
4-24
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906-0731-01 Rev. M
Alarm Turn Off and Cancellation
Alarm Turn Off and Cancellation
The operator may decide, based on their clinical assessment, either to turn off or cancel certain
alarms that, in the given situation, are considered “nuisance” alarms and are not assisted in the
safe management of the patient. Before any such alarms can be turned off or cancelled, the
operator will receive a Pop Up message asking them to confirm their understanding that the
alarm will no longer be available in current operating session.
Alarm Preemptive Mute upon Power up
When the unit 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 list of alarms that have this preemptive mute are:
Alarm
Number
Alarm Name
2062
Exhalation Fault
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-VT High
2173
Spontaneous Breath-VT Low
2300
Pulse Ox Module Failed
2301
Internal Communication Failed
2314
SpO2 Sensor Off Patient
2401
SpO2 Low
2410
Heart Rate High
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ZOLL Portable Critical Care Ventilator Operator’s Guide
4-25
CHAPTER 4 ALARMS
Alarm
Number
Alarm Name
2411
Heart Rate Low (Pulse Rate Low)
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
Alarm Turn Off at Extreme Range Limits
If the operator sets the following alarm limits to their extreme range, the indicated alarms will
be turned off after the Pop Up message confirmation:
1.
2.
High Breath Rate (Alarm #2074)
PIP Low (Alarms #2071, 2171)
a. This changes automatically to off in NPPV.
3. VT High (Alarms #2072, 2172)
a. This changes automatically to off in NPPV.
4. VT Low (Alarms #2073, 2173)
a. This changes automatically to off in NPPV.
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 will be set to the values indicated in the following table. This is done to ensure
patient safety in the event of an inadvertent value change. These values can be changed by the
operator following the parameter change procedures described above.
High Breath
Rate
99 BPM
4-26
PIP Low
3 cm H2O
VT High
2000 ml
VT Low
0 ml
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Low SpO2
86%
High Heart
Rate
240 BPM
Low Heart
Rate
30 BPM
906-0731-01 Rev. M
Alarm Turn Off and Cancellation
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 cancelled for the remainder of the unit’s operating session. The following
constraints apply to this alarm cancellation:
1.
2.
3.
4.
Only alarms that have occurred in the current operating session can be cancelled.
Alarms which have not occurred since turn on will be indicated with a “--”.
Cancelled alarms will not be saved in the User Settings for the next session.
All cancelled alarms will reappear (if appropriate) when the unit is next turned on. (As
an example, the Self Check Fault, calibration due Alarm # 3120, will reappear in the
next operating session.)
The following alarms may be cancelled in the Alarm Configuration Menu:
1.
2.
3.
4.
5.
6.
906-0731-01 Rev. M
Self Check Fault, calibration due (Alarm #3120)
RTC Battery Fault (Battery Low) (Alarm #3110)
Incomplete Exhalation (Alarm #3110)
PEEP Leak (Alarm #2090)
Fresh Gas Intake Fault (Alarm #3031)
Patient Inspiratory Demand Not Met (Alarm #3092)
ZOLL Portable Critical Care Ventilator Operator’s Guide
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CHAPTER 4 ALARMS
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906-0731-01 Rev. M
Chapter 5
Maintenance
The ZOLL ventilator must be maintained to be ready for immediate use. The device should be
incorporated into a regular preventative maintenance program to insure compliance with
operating specifications.
Calibration Checks
Calibration checks should be done every 12 months or 1500 service hours, unless significant
usage warrants a shorter period between preventative maintenance inspections. The device
performs a calibration check as part of the start up routine when the device is powered on.
Following 6-months of continuous storage/non-use, or longer, this device should be examined,
operationally tested, and its batteries recharged before patient-use is attempted. A complete
calibration check should be made by a competent biomedical equipment technician at
12 month/1500 service hour intervals. Calibration checks should be performed as required and
the results recorded. A secure record of these calibration checks should be maintained for
devices not returned to ZOLL for calibration/maintenance. Calibration checks should also be
performed whenever the operator suspects that the unit is not functioning properly or following
mass deployment before the device is returned to storage. If the unit being tested fails the
calibration check, it should be returned to an authorized ZOLL Service Center or ZOLL for
calibration.
Contact an authorized ZOLL Service Center or ZOLL prior to returning this instrument for
scheduled maintenance, calibration, or service (Telephone: 1-973-882-1212,
email: www.zoll.com). A Returned-Goods-Authorization number (RGA #) will be issued. The
RGA # must appear on both the packing slip and address label. This will facilitate better
tracking of the returned item and result in improved scheduling and handling.
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ZOLL Portable Critical Care Ventilator Operator’s Guide
5-1
CHAPTER 5 MAINTENANCE
General Cleaning
Keep the unit and its accessories clean at all times. Never allow grease and/or oil to enter the
system or coat its components. Exposed parts should be dried following usage in wet
environments. Users are encouraged to clean this device and its accessories at regular intervals
and maintain up-to-date records of maintenance and inspections. Internal pneumatic
components are sealed, thus routine maintenance is not required. Pressure hose connections
should be wiped with a damp, soapy cloth and throughly dried with a lint-free cloth. The unit’s
housing should also be cleaned as necessary with damp, soapy cloth and throughly dried with a
lint-free cloth. Do not clean with abrasives or chlorinated hydrocarbon cleansers.
High Pressure Hoses
Examine hoses for cracking, discoloration, and disfigurement. Wipe the exterior wall with a
damp, soapy cloth. Dry with a lint-free cloth. Examine end connection fittings for damaged
threads and sharp edges. Replace if defective, DO NOT attempt to repair.
Warning!
Never use oil or grease of any kind with oxygen or compressed gas equipment.
Preventative Maintenance
Routine maintenance should be performed on this instrument at regular intervals and prior to its
being placed into service. Routine maintenance should consist of the following:
1. Storage -- make sure the ventilator is stored in a clean and dry environment.
2. Operational checks -- with the ventilator not connected to a patient, power cycle the
ventilator after every 1000 hours of use and using a ventilator circuit and test lung, operate
the ventilator at default settings, then change various settings and confirm proper operation,
test disconnect, airway pressure, and SpO2 alarms.
3. Tubing and hose checks -- replace crimped, cracked, or worn tubing and hoses as required.
4. Mechanical components are subject to wear and fatigue over time. Components will
deteriorate more quickly when used continuously. To insure compliance with operating
specifications, it is the user’s responsibility to insure that periodic preventative maintenance
is performed. It is recommended that the In-Field Calibration Check be performed by ZOLL
or a certified ZOLL service facility.
5. ZOLL recommends that on a daily basis, the operator examine the breathing circuit for
damage or wear including but not limited to cracking, discoloration, or disfigurement. If there
is any sign of physical degradation or the unit is indicating breathing circuit problems, the
operator should replace with a new breathing circuit.
Removable Foam Filter Replacement
The Removable Foam Filter is located on the right side of the ventilator. It should be inspected
and replaced if necessary every 1,000 hours of operation or more frequently if used in dusty
environments. Remove the filter using a pair of tweezers or similar tool. Examine the filter for
dirt, lint, or general wear. Replace if necessary.
(Part #465-0028-00). DO NOT attempt to clean the filter.
Caution
5-2
Do not operate the compressor without a filter in place.
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906-0731-01 Rev. M
Fresh Gas/Emergency Air Intake Disk Filter Replacement
Fresh Gas/Emergency Air Intake Disk Filter Replacement
The Fresh Gas/Emergency Air Intake Disk Filter (Part #465-0027-00) is located behind the
Removable Foam Filter. This filter provides a second level of filtration to the ambient air that is
delivered to the patient. This filter must be checked periodically and replaced if necessary. The
unit triggers an alarm when the combination of Removable Foam Filter and
Fresh Gas/Emergency Air Intake Disk Filter become dirty. This alarm signifies that the unit is
still able to deliver the correct tidal volume but one or more of its filters need replacement. The
Fresh Gas/Emergency Air Intake Disk Filter can be visually inspected after the Removable
Foam Filter is removed. If the filter appears discolored, it must be replaced.
Caution
There are no user serviceable parts except the filter components above.
Caution
When used in dusty/dirty environments, the foam and disk filters should be checked, and
replaced as needed. This will prevent particle build up on the transducer screen and the need to
take the unit out of service for maintenance by a biomedical technician.
Caution
If filters have been exposed to biological matter, dispose of them following Universal Precaution
procedures for your facility.
Note:
906-0731-01 Rev. M
Do not attempt to clean this filter and do not operate internal compressor without a
filter in place.
ZOLL Portable Critical Care Ventilator Operator’s Guide
5-3
CHAPTER 5 MAINTENANCE
Internal Filter Change/Insertion
Tools needed:
Hemostat or tweezers
Phillips Head screwdriver
Warning!
Before attempting to replace filters, make sure that external power is disconnected and
the unit’s Power Switch is set to “OFF”.
Procedures:
Foam Filter:
The Foam Filter is located inside the
Compressor Inlet Fitting.
Carefully remove the Foam Filter using a hemostat or tweezers.
DO NOT reuse or attempt to clean the old filter.
Replace the Foam Filter with a new filter. Lightly tap
the new filter into place. The top of the filter should
reside approximately 3/4 to 7/8” below the height of the
22 mm female connector that is part of the Compressor
Inlet Fitting.
Disk Filter:
Remove the four (4)
8-32 x 3 Phillips Flat Head screws that secure the
Compressor Inlet Fitting Assembly to the SPM Chassis.
Lift the two (2) segments of the
Compressor Inlet Fitting Assembly
away from the unit. If the two
segments come apart, do not lose the
gasket that seats between the parts.
5-4
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Alignment Pins
906-0731-01 Rev. M
Internal Filter Change/Insertion
The Disk Filter is now exposed. Do not
remove the filter at this time.
Examine the surface of the Disk Filter.
Do not replace the Disk Filter if it isn’t
discolored. If the Disk Filter is discolored,
replacement is necessary.
Remove the Disk Filter using the hemostat or
tweezers and replace it with a new, clean filter.
Make sure that the filter sits flat on the shoulder in
its recessed area.
Set the lower segment of the Compressor Inlet Fitting Assembly into the unit, making
sure that its alignment pin mates.
Shoulder
Alignment
Hole
Set the upper segment of the Compressor Inlet Fitting Assembly into the lower segment,
making sure that its alignment pin mates.
Secure the Compressor Inlet Fitting Assembly to the SPM Chassis by equally tightening
each of the four (4) 8-32 x 3 Phillips Flat Head screws.
Momentarily turn the unit’s POWER switch to its “ON” position to confirm operating
power.
A DISCONNECT alarm will sound.
Turn the unit’s POWER switch to its “OFF” position.
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ZOLL Portable Critical Care Ventilator Operator’s Guide
5-5
CHAPTER 5 MAINTENANCE
Post-Contaminated Environment Cleaning
If the ventilator is operated in an environment where it may have been exposed to
contamination from a hazardous materials accident, mass epidemic, or weapon of mass
destruction, ZOLL recommends that the guidelines below are followed:
1. Always follow the decontamination procedures specified by the local Incident Command
Safety Officer.
2. Equipment should be cleaned and decontaminated as soon as possible after use. Personnel
should always wear the appropriate Personal Protective Equipment while decontaminating
equipment.
3. The ventilator’s outer case should be cleaned with a damp, soapy cloth and throughly dried
with a lint-free cloth. Make sure that all exposed surfaces are cleaned and dried.
4. For general decontamination/cleaning situations, a 10% bleach solution applied with a damp
cloth is an effective decontaminant that can be used. Since the potential amount of
contaminants that the ventilator might be exposed to is so large, it is difficult to provide an
appropriate cleaning method for each type of exposure. An effective cleaning agent for one
type of exposure may not be effective with another and cleaning and sterilizing practices may
vary between institutions. ZOLL suggests that each facility have in place a procedure for the
cleaning and disinfection of its medical equipment and that these procedures to consulted for
further guidance.
5. Care must be taken to prevent liquids from entering the ventilator. Never submerge the
ventilator and avoid using excessive amounts of water that might enter the unit.
6. Never use abrasives or chlorinated hydrocarbon based cleansers when cleaning the ventilator,
they will damage the plastic and interface lens.
5-6
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906-0731-01 Rev. M
Battery Maintenance
Battery Maintenance
Battery Capacity
While the unit is operating on battery power, operators can best determine the relative amount
of charge in the internal battery by looking at the Battery Icon/Indicator. The Battery icon
appears in outline form and is filled with horizontal rows of lines indicating its current capacity.
Each line represents 5% of battery capacity.
Battery Care and Charging
The unit uses a rechargable lithium-ion battery, which offers a wide temperature operating
range, does not exhibit “memory” characteristics (reduced capacity), or vent hydrogen gas. The
life of this battery depends, to a great extent, upon the care it receives. Avoid exposing it to
direct sunlight or heat sources and never store the battery at temperatures above 76°C (170°F)
for more than 2 hours. Following these simple guidelines will prevent premature charge
depletion and reduction of battery life.
Caution
Only use the Power Supply provided with the unit (ZOLL PN 703-0731-01). Use of any other
power supply could cause damage or create a fire and/or destroy the battery and unit.
Caution
If you witness a battery or the battery compartment starting to balloon, swell up, smoke, or feel
excessively hot, turn off the unit, disconnect external power, and observe it in a safe place for
approximately 15 minutes and send the unit for service. Never puncture or disassemble the
battery packs or cells.
Caution
Never attempt to completely discharge the battery by shorting or some other method and never
ship the battery in a completely discharged state.
Caution
During continuous, uninterrupted use (>100 hours), it is recommended that the ventilator be
disconnected from AC power for 30 seconds to allow the battery to run diagnostics while the
battery is discharging.
Note:
The ventilator continuously monitors the available power sources; occasionally a false
Low Priority power alarm can be triggered for ~1 second. These false alarms
immediately clear themselves.
1. Battery charging is controlled by the ventilator in the temperature range of 0°C to 45°C
(32°F to 113°F) to provide the best life time for the battery.
2. The battery has a discharge (operational) temperature range of -25°C to 49°C (5°F to 71°F)
(as verified by ZOLL).
3. DO NOT store the ventilator with the batteries discharged. Always store with the battery fully
charged.
4. For long-term storage, the optimum storage temperature range is -15°C to 21°C (5°F to
71°F).
906-0731-01 Rev. M
ZOLL Portable Critical Care Ventilator Operator’s Guide
5-7
CHAPTER 5 MAINTENANCE
Lithium-ion batteries exhibit excellent charge retention characteristics. Prolonged periods of
disuse will not substantially reduce operating capability. If long-term storage/non-use is
common, recharge the unit every six months; this will insure that battery charge is maintained
at 80% capacity or better. The unit battery rapidly recharges to 90% of its capacity in
approximately 2 hours. It will take approximately another 2 hours of trickle-charging to top off
the battery to 100% of its capacity. Continuous charging is permissible with the supplied 12
VDC Power Cable or AC/DC Power Supply.
Operating power will always default to the external power source to preserve the internal
battery charge. This assure that power is available for transport use or emergency back up. If
the EXTERNAL POWER LOW/FAIL alarm occurs, the unit will automatically revert to its
internal batteries for operating power.
The Battery Icon/Indicator indicates (1) the presence of a functional battery, (2) when the
battery is charging, and (3) what its current capacity is. The Battery icon appears in outline
form and is filled with horizontal rows of lines indicating its current capacity. When the battery
is charging, these horizontal lines cyclically scroll vertically, one row at a time, from the bottom
row to the top. When the battery is fully charged, the icon is completely filled with lines and
scrolling stops. Each line represents approximately 5% of battery capacity. During internal
battery operation, a horizontal line “disappears” as battery capacity is reduced by a 5%
increment. The Battery icon will flash off/on when a BATTERY POWER LOW alarm occurs.
The icon will flash off/on and present a diagonal line when no battery is connected.
5-8
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906-0731-01 Rev. M
Battery Maintenance
Internal Battery Change/Insertion
Tools needed:
Phillips Head
Screwdriver
Warning!
Before attempting to replace the battery pack (ZOLL PN 703-0731-01), make sure that
external power is disconnected and the unit’s Power Switch is set to “OFF”.
Procedure:
Remove the four (4) 6-32 x 5/16 Phillips Pan Head screws
located at the bottom of the unit. This will release the
Battery Pack Compartment Cover and expose the Battery
Pack and its integral mounting bracket.
Remove the four (4) 6-32 x 2 1/4 Phillips Pan Head screws that
hold the Battery Pack and its integral mounting bracket to the
unit’s Lower Case.
The unit’s Battery Pack is wired to a mating plug-and-socket
connector that remains electrically attached to the unit. This
mating connector includes a locking latch.
While holding the Battery Pack in one hand, pinch the
connector plug locking latch while pulling outward. This
will release the plug from its mating socket and free the
Battery Pack.
Replace the old Battery Pack with a new Battery Pack.
Align the plug, then insert the Battery Pack into its mating socket. The plug and socket are
keyed to protect against misconnection.
Momentarily turn the unit’s POWER switch to its “ON”
position to confirm operating power. A DISCONNECT Alarm
will sound.
Turn the unit’s POWER switch to its “OFF” position.
Secure the Battery Pack with its integral mounting bracket to
the unit’s Lower Case using the four (4) 6-32 x 2 1/4 Phillips Pan Head screws.
Warning!
Make sure that none of the Battery Pack wires get pinched between the bracket and
case enclosure.
Align the Battery Pack Compartment Cover and secure it with the four (4) 6-32 x 5/16 Phillips
Pan Head screws.
Momentarily turn the unit’s POWER switch to its “ON” position to confirm operating power.
A DISCONNECT Alarm will sound. Verify the charge status of the new Battery Pack. Turn the
unit’s POWER switch to its “OFF” position. If required, place the unit on charge.
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ZOLL Portable Critical Care Ventilator Operator’s Guide
5-9
CHAPTER 5 MAINTENANCE
Recharging Guidelines
1. Do not store the ventilator at 100% battery charge in a high temperature environment
(~40°C/104°F and above) for long periods. Doing this may affect the usable life of the
battery.
2. When charging in the storage case, be advised that the battery may stop charging if ambient
temperature is above 40°C/104°F even though the unit is still connected to external power.
Under these conditions, battery temperature can get as high as 10°C/50°F above the ambient
temperature. Charging will automatically start when the ambient temperature drops.
ZOLL Ventilator Storage Case
5-10
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906-0731-01 Rev. M
Troubleshooting
Troubleshooting
Authorization to service this instrument by other than factory-trained and certified personnel
will not be given, nor does ZOLL assume any responsibility and/or liability resulting from such
unauthorized servicing.
Operator Correctable Problems
Common problems may be quickly rectified by the operator following the alarm mitigation
instructions. Should this device fail to operate properly, verify the integrity of all hose, tubing,
and fitting connections. Check all control panel settings and follow the alarm mitigation
instructions provided in the Alarm Message Center (AMC). Verify that the
Fresh Gas/Emergency Air Intake Disk Filter and Removable Foam Filter are not clogged or
dirty. Check for operating power with internal batteries and external power source(s).
Operating Problems Requiring Service
If the tests above do not resolve an operating problem, service is required. Should servicing be
necessary, contact the closest authorized ZOLL Service Center or the ZOLL Customer Service
Department (1-973-882-1212). When calling or emailing for support, be sure to have the
service code number associated with the fault or failure. A Returned-Goods-Authorization
number (RGA #) will be issued if the problem cannot be resolved. The RGA # must appear on
both the packing slip and address label. This will facilitate better tracking of returned items and
result in improved scheduling and handling. Please have the model and serial number ready and
any other pertinent data you wish to include in the service request. The unit’s Serial Number
Label is affixed to the back cover. This information is also contained in the User Menu, Unit
Info.
Storage
For optimal prolonged storage periods, the unit should be stored indoors. The environment
should be clean and out of direct sunlight. Storage in non-controlled environments is
permissible if batteries are removed.
Short-term storage temperature should range between -15°C to 40°C (5°F to 104°F) and
relative humidity should be low. For long-term storage, the optimum storage temperature range
is -15°C to 21°C (5°F to 71°F). Battery life is diminished at temperatures above 35°C (95°F). It
is recommended that batteries be discharged to 50% capacity if long-term storage above 35°C
(95°F) is expected.
Caution
DO NOT store batteries in a discharged condition.
When batteries are in extended storage, it is recommended that they receive a refresh charge at
recommended intervals when not continuously connected to an external power source:
STORAGE AMBIENT
RECHARGE INTERVAL
Below 68°F (20°C)
12 months
68°F to 86°F (20°C to 30°C)
6 months
86°F to 104°F (30°C to 40°C)
3 months
906-0731-01 Rev. M
ZOLL Portable Critical Care Ventilator Operator’s Guide
5-11
CHAPTER 5 MAINTENANCE
Following periods of extended storage in non-controlled environments, allow the unit sufficient
time to stabilize to a temperature within its specified operating range.
Following 6 months of continuous storage/non-use, or longer, the device should be examined,
operationally tested, and its batteries recharged before patient use is attempted. Service may be
required. Servicing should be performed by only qualified personnel.
5-12
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906-0731-01 Rev. M
Appendix A
Specifications
General
Parameter
Operating Range
Operating Modes
EMV+® and Eagle II™: AC,SIMV, CPAP with and without Pressure Support, and with
and without Noninvasive Positive Pressure Ventilation (NPPV/PPV)
AEV®: AC, CPAP with and without Pressure Support, and with Noninvasive Positive
Pressure Ventilation (NPPV)
Breath Target
Volume and pressure
Flow Rate
0 to 100 LPM at 40 cm H2O (3922 Pa)
Breath Rate
1 to 60 BPM
Tidal Volume
50 to 1500 ml ATPD +/- 10% of setting
Inspiratory Time
0.3 to 3.0 seconds
FIO2
21 to 100% +/- 3% of full scale +/- 10% of setting
PEEP
0 to 25 cm H2O (0 to 2451 Pa) (The minimum PEEP in CPAP-NPPV mode is 3 cm
H2O)
Peak Inspiratory Pressure
(PIP)
10 to 80 cm H2O (980 to 7845 Pa) (values >60 cm H2O require secondary user
confirmation) +/- 5 cm H2O +/- 10% of setting
Oxygen Input Pressure
55 psig (-25%; +20%) (379170 Pa)
Airway Pressure High
Limit
20 to 100 cm H2O (1961 to 9806 Pa)
Airway Pressure Low
Limit
Off, 3 to 35 cm H2O (294 to 3432 Pa)
Breath Trigger
-6.0 to -0.5 cm H2O (-588 to -49 Pa) below baseline/PEEP
PIP Bar Graph
-10 to 100 cm H2O (-980 to 9806 Pa)
906-0731-01 Rev. M
ZOLL Portable Critical Care Ventilator Operator’s Guide
A-1
SPECIFICATIONS
Parameter
Operating Range
LED Status/Alarm
Indicator
Red, Yellow, and Green
Alarm Volume
82 dBA @ 1 meter
Noise Level
~60 dBA when measured at 1 meter (operating at default settings using the
compressor only)
Operating Voltages
100 to 240 VAC (50/60 and 400 Hz) or 12.5 to 28.0 VDC, verified by ZOLL
100 to 240 VAC (50/60 Hz) or 12.5 to 28.0 VDC, SGS listed
Operating Time
Internal Battery
Temperature Ranges
Operating
10 hours at default settings
-25°C to 49°C (-13°F to 120°F) with battery discharge and AC power operation based
on ZOLL validation
10°C to 40°C (50°F to 104°F) with battery charging, battery discharge, and AC power
operation (SGS listed)
Battery Charging
0°C to 45°C (32°F to 113°F)
Long Term Storage
-15°C to 21°C (5°F to 71°F) Optimal storage conditions
Control
Accuracy/Precision
± 10% of setting for all measured values and controls not other specified
Size
8.0” Wide X 12.5” High X 4.5” Deep (20.3 cm Wide X 31.8 cm High X 11.4 cm Deep)
Weight
~9.7 lbs (4.4 kg)
Warranty
Limited, 1 year
A-2
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906-0731-01 Rev. M
Pulse Oximeter
Pulse Oximeter
Range
Saturation (% SpO2)
Pulse Rate (bpm)
Perfusion
1%-100%
25-240
0.02%-20%
Accuracy
Saturation (% SpO2)-During No Motion Conditions
Adults, Pediatrics 70%-100% ± 2 digits
0%-69% unspecified
Neonates
70%-100% ± 3 digits
0%-69% unspecified
Saturation (% SpO2)-During Motion Conditions
Adults, Pediatrics 70%-100% ± 3 digits
0%-69% unspecified
Neonates
70%-100% ± 3 digits
0%-69% unspecified
Pulse Rate (bpm)-During No Motion Conditions
Adults, Pediatric, Neonates 25 to 240 ± 3 digits
Pulse Rate (bpm)-During Motion Conditions
Adults, Pediatric, Neonates 25 to 240 ± 5 digits
Resolution
Saturation (% SpO2) 1%
Pulse Rate (bpm) 1
Low Perfusion Performance
>0.02% Pulse Amplitude Saturation (% SpO2) ± 2 digits
and% Transmission >5% Pulse Rate ± 3 digits
Interfering Substances
Carboxyhemoglobin may erroneously increase readings. The level of increase is approximately equal
to the amount of carboxyhemoglobin present. Dyes, or any substance containing dyes, that change
usual arterial pigmentation may cause erroneous readings.
906-0731-01 Rev. M
ZOLL Portable Critical Care Ventilator Operator’s Guide
A-3
SPECIFICATIONS
IEC 60601-1
This unit meets the Classification requirements of IEC 60601-1 (3.1 edition) as indicated by the
following table:
IEC 60601-1 Clause
Category
Classification
6.2
Type of Protection against Electric Class I: Protection against electric shock does not
Shock
rely on Basic Insulation only, but includes an
additional safety precaution in that means are
provided for the connection of the equipment to the
protective earth conductor in the fixed wiring of the
installation in such a way that accessible metal parts
cannot become live in the event of a failure of the
basic insulation. The medical power supply (which
contains the system’s safety barrier) is labeled as
Class I or Class II. Electrical shock protection is not
dependent upon earthing since this power supply
design includes double insulation.
6.2
Degree of Protection against
Electric Shock
BF: Type B with floating (F-type) parts
6.3
Degree of Protection against
Harmful Ingress of Water
IPX4: Splash-proof equipment (protected against
splashing water when enclosed in padded case/rain
flap with bacterial/viral filter protecting compressor.)
6.4
Method of Sterilization or
Disinfection
Pressure hose connections should be wiped with a
damp, soapy cloth and throughly dried with a
lint-free cloth. The unit’s housing should also be
cleaned as necessary with a damp, soapy cloth and
throughly dried with a lint-free cloth. Do not clean
with abrasives or chlorinated hydrocarbon cleansers.
6.5
Degree of Safety of Application in Equipment not suitable for use in presence of
the presence of a Flammable
Flammable Anesthetic Mixture of Air or with Oxygen
Anesthetic Mixture with Air or with or Nitrous Oxide
Oxygen or Nitrous Oxide
6.6
Mode of Operation
Continuous Operation
7.9.2.5
Applied Parts
Ventilator circuit is Type BF applied part. Pulse
Oximeter is Type BF Defibrillation Proof Applied
Part.
A-4
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906-0731-01 Rev. M
IEC 60601-1
The following tables provide the EMC test specifications as required by IEC 60601-1-2.
IEC 60601-1-2 clause 5.2.2.1 c
Guidance and manufacturer’s declaration-electromagnetic emissions
The ZOLL ventilators are intended for use in the electromagnetic environment specified below. The customer or user of
the ventilator should ensure that they are used in such an environment
Emissions test
Compliance
Electromagnetic environment-guidance
RF emissions
CISPR 11
Group 1
The ZOLL ventilators use RF energy only for their internal function.
Therefore, their RF emissions are very low and are not likely to cause
any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class A
Harmonic emissions
IEF 61000-3-2
Class A
The ZOLL ventilators are suitable for use in all establishments other
than domestic and those directly connected to the public
low-voltage power supply network that supplies buildings used for
domestic purposes.
Voltage
fluctuations/flicker
emissions
IEC 61000-3-3
Complies
IEC 60601-1-2 clause 5.2.2.1 f
Guidance and manufacturer’s declaration-electromagnetic emissions
The ZOLL ventilators are intended for use in the electromagnetic environment specified below. The customer or user of
the ventilator should ensure that they are used in such an environment
Immunity Test
IEC 60601 test level
Compliance level
Electromagnetic environment-guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
+/- 6 kV contact
+/- 8 kV air
+/- 6 kV contact
+/- 8 kV air
Floors should be wood, concrete, or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
+/- 2 kV for power
supply lines
+/- 1 kV for
input/output lines
+/- 2 kV for power
supply lines
+/- 1 kV for
input/output lines
Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
+/- 1 kV line(s) to
line(s)
+/- 2 kV line(s) to earth
+/- 1 kV line(s) to
line(s)
+/- 2 kV line(s) to earth
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips, short
interruptions, and
voltage variations
on power supply
input lines
IEC 61000-4-11
< 5% UT
(> 95% dip in UT)
for 0.5 cycles
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
< 5% UT
(> 95% dip in UT)
for 5 sec
< 5% UT
(> 95% dip in UT)
for 0.5 cycles
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
< 5% UT
(> 95% dip in UT)
for 5 sec
Mains power quality should be that of a typical
commercial or hospital environment. If the
user of the ZOLL ventilators requires
continued operation during power mains
interruptions, it is recommended that the
ventilator be powered from an uninterruptible
power supply or a battery.
Power frequency
(50/60) magnetic
field IEC 6100-4-8
3 A/m
3 A/m
Power frequency magnetic fields should be at
levels characteristic of a typical location at a
typical commercial or hospital environment.
Note:
UT is the AC mains voltage prior to application of the test level
906-0731-01 Rev. M
ZOLL Portable Critical Care Ventilator Operator’s Guide
A-5
SPECIFICATIONS
IEC 60601-1-2 clause 5.2.2.2: life support equipment
Guidance and manufacturer’s declaration-electromagnetic emissions
The ZOLL ventilators are intended for use in the electromagnetic environment specified below. The customer or user of the
ventilator should ensure that they are used in such an environment
Immunity Test
IEC 60601 test level
Compliance level
Electromagnetic environment-guidance
Portable and mobile RF communications
equipment should be used no closer to any part
of the ZOLL ventilator, including cables, then
the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter. Recommended
separation distance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
outside ISM bandsa
3V
d = 1.17 √P
10 Vrms
150 kHz to 80MHz
outside ISM bandsa
10 V
d = 1.12 √P
10 V/m
80 MHz to 2.5 GHz
20 V/m
d = 0.6 √P 80 MHz to 800 MHz
d = 1.15 √P 800 MHz to 2.5 MHz
Where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters
(m).b
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site surveyc,
should be less than the compliance level in
each frequency range.d
Interference may occurring the vicinity of
equipment marked with the following symbol:
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people.
a. The ISM (industrial, scientific, and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to
13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
b. The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz
are intended to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently
brought into patient areas. For this reason, an additional factor of 10/3 has been incorporated into the formula used in calculating the
recommended separation distance for transmitters in these frequency ranges.
c. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur
radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the ventilator is used exceeds the applicable RF compliance level above, the ventilator should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or
relocating the ventilator.
d. Over the frequency range 150 kHz to 80 MHz, field strength should be less than 3 V/m.
A-6
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906-0731-01 Rev. M
IEC 60601-1
IEC 60601-1-2 clause 5.2.2.2: life support equipment
Recommended separation distances between portable and mobile RF communications equipment and the
ZOLL ventilators.
The ZOLL ventilators are intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the ZOLL ventilators can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and the
ZOLL ventilators as recommended below, according to the maximum output power of the communication
equipment.
Rated maximum output
power of transmitter (W)
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz
outside ISM bands
150 kHz to 80
MHz in ISM bands
80 MHz to 800
MHz
800 MHz to 2.5
GHz
d = 1.17 √P
d = 1.12 √P
d = 0.6 √P
d = 1.15 √P
0.01
0.117
0.12
0.06
0.115
0.1
0.37
0.38
0.19
0.36
1
1.17
1.2
0.6
1.15
10
3.7
3.8
1.9
3.6
100
11.7
12
6
11.5
For transmitters rated at a maximum output power not listed above, the recommended separation distance d
in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is
the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency applies.
Note 2: The ISM (industrial, scientific, and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795
MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
Note 3: An additional factor of 10/3 has been incorporated into the formula used in calculating the recommended
separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the
frequency range of 80 MHz to 2.5 GHz to decrease the likelihood that mobile/portable communications
equipment could cause interference if it is inadvertently brought into patient areas.
Note 4: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects, and people.
906-0731-01 Rev. M
ZOLL Portable Critical Care Ventilator Operator’s Guide
A-7
SPECIFICATIONS
The unit was tested for the effect of pressure at the patient connection port (e.g airway pressure)
on the VT and Oxygen concentration.
The tests consisted of a core matrix of volume or pressure targets for a set of resistances and
compliances, based on the ASTM F1100 guidance. These test cases were then performed at
different PEEP targets, FIO2 settings, and with different patient circuit accessories and Fresh
Gas Intake accessories. The possible settings and accessories are listed below:
Setting/Accessories
Value
PEEP Settings
0, 5, 25
FIO2 Settings
21, 30, 50, 90, 100
Patient Circuit Accessories
No Accessory
HME
HME + BV
HMEBV
Intake Filter Accessories
No Accessory
C2A1
BV Filter
O2 Reservoir
The following accuracies/precision were observed for adult settings with non-MRI breathing
circuit:
A-8
Parameter
Accuracy/Precision
VT, Tidal Volume
± 10% of setting
Pressure Target Accuracy
± 5 cm H2O for setting < 30, else ± 10 cm H2O
PEEP Accuracy
± 1.5 cm H2O ± 10 of setting
FIO2 Accuracy
± 3% of full scale ± 10 of setting
www.zoll.com
906-0731-01 Rev. M
Appendix B
Accessories
The following accessories are comparable for use with the ZOLL ventilator. To order any of
these items, contact ZOLL or your local distributor.
Part Number
Part Description
024-0012-00
AC/DC Power Supply, 100-240 VAC, 100 W, 24 V, 4.2 A, IEC 320 Plug
708-0042-00
AC Power line cord, 6’ (United States Version)
703-0731-01
Battery Pack, 6.6 Ah, 14.8 V, Lithium-Ion, 4S3P
710-0731-01
AC/DC Power Supply and Line Cord with NEMA 5-15P termination
704-0EMV-XX
Extension Cord 8’ US Hospital Grade Female Plug to Country-Specific Connector (Contact
factory for complete part number for each country)
708-0041-XX
Cordset, 6’, IEC 60320-C5 Plug to Country-Specific Connector (Contact factory for complete
part number for each country)
402-0032-00
Padded Carry Case, Tan, for Ventilator and Accessories
465-0024-00
Filter, Bacterial/Viral (B/V)
465-0025-00
Filter, HME/B/V, Heat and Moisture Exchanger
465-0027-00
Filter, Disk, B/V, Emergency Air Intake
465-0028-00
Removable foam compressor inlet filter
820-0108-00
Heat and Moisture Exchanger/Bacterial and Viral Filter (HMEF), Adult, Deadspace ≤ 75ml
820-0108-25
Heat and Moisture Exchanger/Bacterial and Viral Filter (HMEF), Adult, Deadspace ≤ 75ml
(Case of 25)
820-0109-00
Heat and Moisture Exchanger/Bacterial and Viral Filter (HMEF), Pediatric, Deadspace ≤ 25ml
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ZOLL Portable Critical Care Ventilator Operator’s Guide
B-1
ACCESSORIES
Part Number
Part Description
820-0109-25
Heat and Moisture Exchanger/Bacterial and Viral Filter (HMEF), Pediatric, Deadspace ≤ 25ml
(Case of 25)
820-0110-00
Heat and Moisture Exchanger/Bacterial and Viral Filter (HMEF), Inant, Deadspace ≤ 10ml
820-0110-25
Heat and Moisture Exchanger/Bacterial and Viral Filter (HMEF), Inant, Deadspace ≤ 10ml
(Case of 25)
820-0111-00
Adaptor, Metered Dose Inhaler, Adult
820-0111-25
Adaptor, Metered Dose Inhaler, Adult (Case of 25)
820-0112-00
Adaptor, Metered Dose Inhaler, Pediatric/Infant
820-0112-25
Adaptor, Metered Dose Inhaler, Pediatric/Infant (Case of 25)
704-0004-00
3 Liter O2 Reservoir Kit
704-0EMV-05
DC Power Cable, 28 VDC, Military Vehicle
704-0EMV-06
DC Power Cable, 12 VDC. Ambulance
708-0036-00
Cable, 3ft, Masimo SET Oximeter, LNCS Type DC-1, Adult Digit Sensor to DB9 Male
Note: All LNCS Masimo cables are approved for use with the ZOLL ventilators
708-0037-00
Cable, 4ft, Masimo LNCS Patient Cable Type LNC-4, DB9 Female to Male
Note: All LNCS Masimo cables are approved for use with the ZOLL ventilators
708-0039-00
Cable, 3ft, Masimo Adult Ear Sensor, LNCS Type DC-1, Adult Sensor to DB9 Male
Note: All LNCS Masimo cables are approved for use with the ZOLL ventilators
708-0046-00
Cable, 6ft, BS 546 (UK-SA) Plug Right Angle
708-0047-00
Cable, 3ft, Masimo SET Oximeter, LNCS Type Inf/Inf-3, Infant Sensor to DB9 Male
708-0052-00
Cable, 3ft, Pulse Oximeter, Reusable, Finger Sensor, Pediatric
708-0053-00
Cable, 18”, Pulse Oximeter, Disposable, Finger Sensor, Adult
708-0054-00
Cable, 18”, Pulse Oximeter, Disposable, Finger Sensor, Pediatric
708-0056-00
Cable, 3ft, Masimo SET Oximeter, LNCS Type DC-1, Adult Digit Sensor to DB9 Male, Single
Patient
Note: All LNCS Masimo cables are approved for use with the ZOLL ventilators
708-0057-00
Cable, 3ft, Masimo SET Oximeter, LNCS Type DC-1, Pediatric Digit Sensor to DB9 Male,
Single Patient
Note: All LNCS Masimo cables are approved for use with the ZOLL ventilators
708-0063-00
Extension Cord Assembly, AS 3112 (Australian) Plug to US Hospital Grade Plug
708-0064-00
Cable, 6ft, Continental Europe CEE 7/7 to IEC-60320-C5 2.5 Amp Connector
820-0106-00
Circuit, Vent, Single Limb, Pediatric/Adult (disposable)
820-0106-15
Circuit, Vent, Single Limb, Pediatric/Adult (disposable) (Case of 15)
820-0107-00
Circuit, Vent, Single Limb, Infant/Pediatric (disposable)
820-0107-20
Circuit, Vent, Single Limb, Infant/Pediatric (disposable) (Case of 20)
B-2
www.zoll.com
906-0731-01 Rev. M
Part Number
Part Description
820-0130-00
MRI Circuit, Vent, Single Limb, Pediatric/Adult (disposable)
820-0130-10
MRI Circuit, Vent, Single Limb, Pediatric/Adult (disposable) (Case of 10)
820-0131-00
MRI Circuit, Vent, Single Limb, Infant/Pediatric (disposable)
820-0131-10
MRI Circuit, Vent, Single Limb, Infant/Pediatric (disposable) (Case of 10)
820-0133-00
Circuit, Vent, Single Limb, Wye, Adult/Pediatric (disposable) with Accessory Port Connector
820-0133-15
Circuit, Vent, Single Limb, Wye, Adult/Pediatric (disposable) with Accessory Port Connector
(Case of 15)
820-0134-00
MRI Circuit, Vent, Single Limb, Wye, Adult/Pediatric (disposable) with Accessory Connector
820-0134-10
MRI Circuit, Vent, Single Limb, Wye, Adult/Pediatric (disposable) with Accessory Connector
(Case of 10)
825-0002-00
High pressure Oxygen Hose, DISS x DISS, oxygen, 6’
907-0731-03
Quick Reference Guide, laminated, Model 731 (non-MRI)
907-0731-04
Quick Reference Guide, laminated, Model 731 (MRI)
907-0731-05
Tag, Laminated, MRI Cautions/Warnings
906-0731-01
Operator’s Guide (Commercial), Model 731
909-0731-01
CD format Operator’s Guide (Commercial), Model 731
906-0731-03
Operator’s Guide (Military), Model 731
909-0731-02
CD format Operator’s Guide (Military), Model 731
906-0731-06
Operator’s Guide (Commercial, Spanish), Model 731
909-0731-06
CD format Operator’s Guide (Commercial, Spanish), Model 731
906-0731-07
Operator’s Guide (Commercial, Portuguese), Model 731
909-0731-07
CD format Operator’s Guide (Commercial, Portuguese), Model 731
906-0731-08
Operator’s Guide (Commercial, Polish), Model 731
909-0731-09
CD format Operator’s Guide (Commercial, Polish), Model 731
906-0731-04
Service Manual
909-0731-04
CD format Service Manual
816-0731-00
Non-MRI Rolling Cart
816-0731-01
MRI conditional Rolling Cart
704-0731-09
IV support arm for Rolling Cart (aluminum, MRI safe)
820-0124-00
Breathing Circuit support arm for Rolling Cart (ferrous, not for MRI use)
800-0904-01
CCLAW (Critical Care Litter Attachment Widget) Mounting Bracket
703-0731-03
Carry-all Case with Foam Inserts, without AC Receptacle
703-0EMV-03
Carry-all Case with AC Receptacle
906-0731-01 Rev. M
ZOLL Portable Critical Care Ventilator Operator’s Guide
B-3
ACCESSORIES
Part Number
Part Description
703-0731-11
Case, Transit Carry
703-0731-12
Case, Transit Carry, with AC Bulkhead Connector
703-0731-13
Case, Transit Carry, with AC Bulkhead & USB Connectors
703-0731-14
Case, Transit Carry, with Wheels & Pull-Out Handle
703-0731-15
Case, Transit Carry, with Wheels & Pull-Out Handle, AC Bulkhead Connector
704-0700-01
Check Valve Kit
812-0011-00
Mask, CPAP, #6, Large Adult
812-0011-20
Mask, CPAP, #6, Large Adult (Case of 20)
812-0010-00
Mask, CPAP, #5, Adult
812-0010-20
Mask, CPAP, #5, Adult (Case of 20)
812-0009-00
Mask, CPAP, #4, Child
812-0009-20
Mask, CPAP, #4, Child (Case of 20)
812-0008-00
Mask, CPAP, #3, Small Child
812-0008-20
Mask, CPAP, #3, Small Child (Case of 20)
812-0008-40
Mask, CPAP, #3, Small Child (Case of 40)
812-0007-00
Mask, CPAP, #2, Infant
812-0007-20
Mask, CPAP, #2, Infant (Case of 20)
812-0007-40
Mask, CPAP, #2, Infant (Case of 40)
812-0006-00
Mask, CPAP, #1, Small Infant
712-0004-00
Mask, CPAP, #4, Child with harness
712-0004-20
Mask, CPAP, #4, Child with Harness (Case of 20)
712-0004-50
Mask, CPAP, #4, Child with Harness (Case of 50)
712-0002-00
Mask, CPAP, #5, Adult with Harness
712-0002-20
Mask, CPAP, #5, Adult with Harness (Case of 20)
712-0002-50
Mask, CPAP, #5, Adult with Harness (Case of 50)
712-0003-00
Mask, CPAP, #6, Large Adult with Harness
712-0003-20
Mask, CPAP, #6, Large Adult with Harness (Case of 20)
712-0003-50
Mask, CPAP, #6, Large Adult with Harness (Case of 50)
334-0125-00
Harness, Mask, Universal
334-0125-00
Harness, Mask, Universal (Case of 10)
820-0132-00
600 ml ZOLL Test Lung, plastic/silicone
B-4
www.zoll.com
906-0731-01 Rev. M
Index
A
Abbreviations .............................................................................................................................. 1-6
Accessories .........................................................................................................................B-1–B-4
Adjuncts of Operation .......................................................................................................... 3-4–3-6
Alarm
Cancellation in Alarm Configuration Menu ....................................................................... 4-27
Categories ...................................................................................................................... 4-4–4-8
List ............................................................................................................................... 4-9–4-24
Device .................................................................................................................. 4-11–4-21
Environmental ...................................................................................................... 4-22–4-24
Patient .................................................................................................................... 4-9–4-10
Priorities ................................................................................................................................ 4-3
Turn Off and Cancellation ......................................................................................... 4-25–4-26
Turn Off at Extreme Range Limits ..................................................................................... 4-26
Assembly .................................................................................................................................... 1-2
B
Back Up Ventilator ..................................................................................................................... 3-9
Battery
Capacity ................................................................................................................................ 5-7
Care and Charging ......................................................................................................... 5-7–5-8
Change/Insertion ................................................................................................................... 5-9
Recharging .......................................................................................................................... 5-10
Begin Ventilating ................................................................................................................. 3-7–3-8
C
Cautions .................................................................................................................................... 1-11
Change Settings ................................................................................................................... 3-8–3-9
Connector Panel
Exhalation Valve ................................................................................................................... 2-7
External Power Input ............................................................................................................ 2-7
Fresh Gas/Emergency Air Intake .......................................................................................... 2-7
Gas Output ............................................................................................................................ 2-7
Oxygen Input ........................................................................................................................ 2-7
Pulse Oximeter Connector .................................................................................................... 2-7
Transducer (Patient Airway Pressure) .................................................................................. 2-7
USB Connector ..................................................................................................................... 2-7
Controls .............................................................................................................................. 2-8–2-16
BPM (Breathing Rate) ............................................................................................... 2-11–2-12
Confirm/Select .................................................................................................................... 2-13
FIO2 .................................................................................................................................... 2-10
HR ................................................................................................................................ 2-9–2-10
Manual Breath ..................................................................................................................... 2-13
Menu ..........................................................................................................................2-13–2-16
Mode ..........................................................................................................................2-12–2-13
906-0731-01 Rev. M
ZOLL Portable Critical Care Ventilator Operator’s Guide
Index-1
Mute/Cancel ........................................................................................................................ 2-13
PIP ....................................................................................................................................... 2-11
Power Off/On ...................................................................................................................... 2-13
Rotary Encoder ................................................................................................................... 2-13
SpO2 ................................................................................................................................... 2-10
Tidal Volume ...................................................................................................................... 2-11
Conventions ................................................................................................................................ 1-5
D
Display Screen .................................................................................................................2-17–2-19
Airway Pressure/Measured Values ..................................................................................... 2-19
Alarm Triangle Icon ............................................................................................................ 2-19
Battery Icon ......................................................................................................................... 2-19
BPM (Breathing Rate) ........................................................................................................ 2-18
Current Mode ...................................................................................................................... 2-18
External Power Icon ............................................................................................................ 2-18
FIO2 .................................................................................................................................... 2-18
Head with Mask Icon .......................................................................................................... 2-19
HR ....................................................................................................................................... 2-17
Mode ................................................................................................................................... 2-18
Oxygen Supply Icon ........................................................................................................... 2-19
PIP ....................................................................................................................................... 2-18
Pressure/Time Plot .............................................................................................................. 2-18
Pulse Pleth/Time Plot .......................................................................................................... 2-18
Speaker (Mute/Unmute) Icon ............................................................................................. 2-19
SpO2 ................................................................................................................................... 2-17
Status Indicator LED Array ................................................................................................ 2-18
Tidal Volume ...................................................................................................................... 2-18
F
FDA Tracking ........................................................................................................................... 1-12
Features ....................................................................................................................................... 2-4
G
Gas Sources ...................................................................................................................... 2-24–2-25
Guide Updates ............................................................................................................................. 1-1
H
Harsh Environment Operation
Airborne Particulates .......................................................................................................... 3-13
Altitude ............................................................................................................................... 3-14
Extreme Temperature Environments .................................................................................. 3-13
Rain and Snow .................................................................................................................... 3-14
Hazardous Environment Filters ....................................................................................... 3-11–3-12
Bacterial/Viral ..................................................................................................................... 3-11
Change/Insertion ............................................................................................................ 5-4–5-5
Check Valve on Breathing Circuit ...................................................................................... 3-12
Chemical/Biological ........................................................................................................... 3-12
Foam Filter ............................................................................................................................ 5-2
Fresh Gas/Emergency Air Intake Disk Filter ....................................................................... 5-3
Index-2
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906-0731-01 Rev. M
How to Use ................................................................................................................................. 1-1
Humidification ...................................................................................................................3-9–3-10
I
Indications ................................................................................................................................... 1-7
Features ................................................................................................................................. 1-7
L
Limited Warranty ...................................................................................................................... 1-14
M
Maintenance
Calibration Checks ................................................................................................................ 5-1
General Cleaning .................................................................................................................. 5-2
Operating Problems Requiring Service .............................................................................. 5-11
Operator Correctable Problems .......................................................................................... 5-11
Post-Contaminated Environment Cleaning .......................................................................... 5-6
Preventative Maintenance ..................................................................................................... 5-2
MRI
Hazard Assessment ............................................................................................................. 3-20
Test Details ................................................................................................................ 3-18–3-19
Ventilator and Stand Configuration .................................................................................... 3-19
Warnings and Cautions .............................................................................................. 3-21–3-22
N
Notification of Adverse Events ................................................................................................. 1-13
O
Operation
Additional Adjuncts ....................................................................................................... 3-4–3-6
Modes of ............................................................................................................................... 3-3
P
Pneumatic Diagram ..................................................................................................................... 2-6
Pop Up Messages ............................................................................................................. 2-20–2-22
List ............................................................................................................................. 2-21–2-22
Power
Connections ........................................................................................................................ 2-30
Selection .............................................................................................................................. 2-29
Pulse Oximeter
Description ............................................................................................................................ 3-9
Principles ................................................................................................................... 2-32–2-33
Specifications ....................................................................................................................... A-3
S
Self-Check ................................................................................................................................ 2-31
Service ............................................................................................................................. 1-15–1-16
Set-up ........................................................................................................................................ 2-23
Smart Help Messages ........................................................................................................... 4-2–4-3
Software License ....................................................................................................................... 1-13
Specifications
Accuracy/Precision .............................................................................................................. A-8
General ......................................................................................................................... A-1–A-2
906-0731-01 Rev. M
ZOLL Portable Critical Care Ventilator Operator’s Guide
Index-3
IEC 60601-1 Classifications ........................................................................................ A-4–A-7
Pulse Oximeter ..................................................................................................................... A-3
Spontaneous/Assisted Breath Trigger .................................................................................. 3-6–3-7
Storage ............................................................................................................................. 5-11–5-12
Symbols ............................................................................................................................... 1-2–1-5
T
Transducer Calibration (AUTO CAL) ...................................................................................... 2-31
U
Unpacking ................................................................................................................................... 1-2
Use of Low Flow Oxygen ................................................................................................ 3-15–3-17
Operating Notes ......................................................................................................... 3-16–3-17
Procedure ............................................................................................................................ 3-15
V
Ventilator Circuit
Connections ........................................................................................................................ 2-26
Patient Connections ............................................................................................................ 2-27
Resistance, Compliance, and Deadspace ................................................................... 2-28–2-29
Ventilator Models
AEV ...................................................................................................................................... 2-2
Common Features ................................................................................................................. 2-1
Eagle II .................................................................................................................................. 2-3
EMV+ ................................................................................................................................... 2-2
MRI Variants ........................................................................................................................ 2-3
W
Warnings ............................................................................................................................ 1-8–1-11
General ........................................................................................................................... 1-8–1-9
Pulse Oximeter ........................................................................................................... 1-10–1-11
Index-4
www.zoll.com
906-0731-01 Rev. M
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