ZOLL 731 Series Manual

Portable Critical Care Ventilator
Operator’s Guide
Models: EMV+, AEV, Eagle II
731 Series
906-0731-01 Rev. J

The issue date for the ZOLL Portable Critical Care Ventilator Operator’s Guide (REF 906-0731-01 Rev. J)
is June, 2017.
Copyright © 2015 ZOLL Medical Corporation. All rights reserved. ZOLL, AEV, EMV+, Eagle II and
Smart Help are registered trademarks or trademarks of ZOLL Medical Corporation in the United States and/or
other countries. All other trademarks are the property of their respective owners.
Masimo Pulse Oximeter
This device uses Masimo SET® technology to provide continuous pulse oximeter and heart rate monitoring and
is covered under one or more of the following U.S.A. patents: 5,758,644, 5,823,950, 6,011,986, 6,157,850,
6,263,222, 6,501,975 and other applicable patents listed at www.masimo.com/patents.htm.
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.
0123
ZOLL Medical Corporation
269 Mill Road
Chelmford, MA USA
01824-4105
ZOLL Medical Corporation
Newtonweg 18
6662 PV ELST
The Netherlands

906-0731-01 Rev. J ZOLL Portable Critical Care Ventilator i
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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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

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Alarm Turn Off and Cancellation....................................................................................... 4-25
Alarm Turn Off at Extreme Range Limits .................................................................. 4-26
Alarm Cancellation in Alarm Configuration Menu ..................................................... 4-27
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 1906-0731-01 Rev. J
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. If more than 3 years have
elapsed since this date, contact ZOLL Medical Corporation to determine if additional product
information updates are available.
All users should carefully review each manual update to understand its significance and then
file it in its appropriate section within this manual for subsequent reference.
Product documentation is available through the ZOLL website at www.zoll.com. From the
Products menu, choose Product Manuals.

GENERAL INFORMATION
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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 Recharging”
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.

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Defibrillation Proof: Indicates the degree of protection against electrical
shock.
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.
Symbol Description

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No Internal Battery: Indicates when internal battery is not an available
power source.
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.
Symbol Description

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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.
Consult Instruction: Consult the instructions for use or operation manual.
Symbol Description

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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
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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Warnings
General
•Electric shock hazard: Do not remove equipment covers except to replace the batteries. An
operator may only perform maintenance procedures specifically described in this manual.
Refer servicing to ZOLL®or an authorized ZOLL®Service Center in the repair of this
equipment.
•The device is intended for use by qualified personnel only. The operator should read this
manual, all precautionary information, and specifications before using the device.
•Possible explosion hazard if used in the presence of flammable anesthetics or other
flammable substances in combination with air, oxygen-enriched environments, or nitrous
oxide.
•During operation, the unit should not be stacked on top of or under other medical equipment
due to the possibility of electromagnetic interference between the unit and other equipment.
Before using on a patient, the operator should observe the device in its normal configuration
to assure that EMC interference between equipment is not occurring. (The unit was
subjected to EMC testing in accordance with Military Mil-STD-461F, Commercial IEC
60601-1-2, and FDA Reviewers Guidance specification.)
•The equipment set up should not prevent this device from being disconnected from the
mains power in an emergency.
•The use of accessories and cables other than those specified, with the exception of
accessories and cables sold by ZOLL as replacement parts for internal components, may
result in increased emissions or decreased immunity of this device.
Note: The operator should be aware that this device needs special precautions regarding
EMC and needs to be installed and put into service according to the EMC
information provided in this document.
•The operator should be aware that portable and mobile RF communication equipment may
affect the performance of this device. The EMC test specifications for this device are
located in the Specifications section of this 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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•Do not place the unit or external power supply in any position that might cause it to fall on
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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Pulse Oximeter
•A pulse oximeter should not be used as an apnea monitor.
•A pulse oximeter should be considered an early warning device. As a trend towards patient
deoxygenation is indicated, blood samples should be analyzed by a laboratory co-oximeter
to completely understand the 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 SpO2measurements. 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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•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.
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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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
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906-0731-01 Rev. J ZOLL Portable Critical Care Ventilator 1-13
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.

GENERAL INFORMATION
1-14 www.zoll.com 906-0731-01 Rev. J
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.