ZOLL EMV+, AEV, Eagle II User manual
ZOLL Ventilator Operator’s
Guide
Models: EMV+, AEV, Eagle II
906-0731-01-05 Rev. B
The issue date for the ZOLL Ventilator Operator’s Guide (REF 906-0731-01-05 Rev. B) is May, 2017.
0123
ZOLL Medical Corporation
269 Mill Road
Chelmsford, MA USA
01824-4105
ZOLL International Holding B.V.
Newtonweg 18
6662 PV ELST
The Netherlands
Copyright © 2017 ZOLL Medical Corporation. All rights reserved. ZOLL, AEV, and EMV+ are registered
trademarks of ZOLL Medical Corporation in the United States and/or other countries. Eagle II and Smart Help
are 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® tec hnology to provide conti nuous 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.
Chapter 1 General Information
PRODUCT DESCRIPTION .................................................................................................. 1-1
HOW TO USE THIS MANUAL............................................................................................. 1-1
OPERATOR’S GUIDE UPDATES ......................................................................................... 1-2
UNPACKING .................................................................................................................... 1-2
ASSEMBLY ...................................................................................................................... 1-2
SYMBOLS ON THE VENTILATOR1-..................................................................................... 1-2
SYMBOLS ON THE VENTILATOR’S GRAPHICAL USER INTERFACE (GUI)............................... 1-5
CONVENTIONS ................................................................................................................ 1-7
ABBREVIATIONS .............................................................................................................. 1-8
ZOLL VENTILATOR INDICATIONS FOR USE........................................................................ 1-9
WARNINGS.....................................................................................................................1-11
FDA TRACKING REQUIREMENTS .................................................................................... 1-16
SOFTWARE LICENSE...................................................................................................... 1-17
SERVICE....................................................................................................................... 1-19
Chapter 2 Product Overview
ZOLL VENTILATOR MODELS ............................................................................................ 2-2
ZOLL VENTILATOR FEATURES ......................................................................................... 2-3
ZOLL VENTILATOR DEVICE DESCRIPTION ........................................................................ 2-4
CONTROLS AND INDICATORS............................................................................................ 2-6
DISPLAY SCREEN ............................................................................................................ 2-7
PNEUMATIC DESIGN ........................................................................................................ 2-9
FRESH GAS INTAKE AND ATTACHMENTS ......................................................................... 2-10
TOP PANEL ................................................................................................................... 2-10
VENTILATOR CIRCUITS................................................................................................... 2-12
PULSE OXIMETER SENSORS .......................................................................................... 2-14
POWER SOURCES......................................................................................................... 2-14
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Chapter 3 Setting Up the ZOLL Ventilator
1. ATTACH THE VENTILATOR CIRCUIT ............................................................................... 3-2
2. ATTACH THE HIGH PRESSURE OXYGEN SUPPLY (OPTIONAL) ......................................... 3-3
3. INSPECT FRESH GAS INTAKE FILTERS .......................................................................... 3-3
4. CONNECT FRESH GAS INTAKE ATTACHMENTS............................................................... 3-4
5 SELECT THE VENTILATOR’S POWER SOURCE ................................................................ 3-5
6. POWER ON THE VENTILATOR....................................................................................... 3-7
7. SELECT START UP DEFAULT VALUES ........................................................................... 3-8
8. SELECT OPERATING MODE (OPTIONAL) ..................................................................... 3-10
9. CHANGE PARAMETER VALUES ....................................................................................3-11
10. CHANGE VENTILATOR SETTINGS ...............................................................................3-11
11. PERFORM OPERATIONAL TEST................................................................................. 3-12
12. ATTACH THE PULSE OXIMETER PROBE (OPTIONAL) .................................................. 3-13
13. ATTACH PATIENT ..................................................................................................... 3-13
Chapter 4 Using the ZOLL Ventilator
THE VENTILATOR INTERFACE ........................................................................................... 4-2
PARAMETER BUTTONS..................................................................................................... 4-3
MODE............................................................................................................................. 4-3
BPM (BREATHES PER MINUTE) -- TIMING AND RATE MANAGEMENT .................................. 4-5
VT (TIDAL VOLUME) ........................................................................................................ 4-8
PIP (PEAK INSPIRATORY PRESSURE) -- LUNG PRESSURE MANAGEMENT........................... 4-9
FIO2 (FRACTION OF INSPIRED OXYGEN) -- OXYGEN DELIVERY MANAGEMENT..................4-11
SPO2 -- USING THE PULSE OXIMETER........................................................................... 4-12
HR (HEART RATE) ........................................................................................................ 4-15
MANAGING POP UP MESSAGES..................................................................................... 4-16
MANAGING ALARMS....................................................................................................... 4-17
SILENCING ALARMS....................................................................................................... 4-21
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Chapter 5 Alarms
ALARM OVERVIEW .......................................................................................................... 5-2
ALARM PRIORITIES.......................................................................................................... 5-4
MUTING ALARMS ............................................................................................................. 5-5
ALARMS TYPES............................................................................................................... 5-5
ALARM GROUPS ............................................................................................................. 5-6
HIGH PRIORITY ALARMS .................................................................................................. 5-8
MEDIUM PRIORITY ALARMS............................................................................................ 5-12
LOW PRIORITY ALARMS ................................................................................................. 5-18
POP UP MESSAGES ...................................................................................................... 5-26
Chapter 6 Operating Environments
USING THE ZOLL VENTILATOR IN HARSH ENVIRONMENTS ................................................ 6-1
USING THE ZOLL VENTILATOR IN HAZARDOUS ENVIRONMENTS ........................................ 6-4
USING THE ZOLL VENTILATOR IN AN MRI ENVIRONMENT ................................................. 6-7
Chapter 7 Maintenance
INSPECTING THE ZOLL VENTILATOR ................................................................................ 7-1
CLEANING....................................................................................................................... 7-2
GAS INTAKE FILTERS....................................................................................................... 7-3
REPLACING THE ZOLL VENTILATOR’S FILTERS ................................................................. 7-4
BATTERY MAINTENANCE.................................................................................................. 7-5
CALIBRATION CHECKS..................................................................................................... 7-8
TROUBLESHOOTING......................................................................................................... 7-9
Appendix A Specifications
GENERAL........................................................................................................................A-1
PULSE OXIMETER ...........................................................................................................A-3
DEVICE CLASSIFICATION..................................................................................................A-4
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Appendix B Accessories
Appendix C
Pulse Oximeter Principles
Appendix D Patient Circuits
PEDIATRIC/ADULT, SINGLE-LIMB, WYE PATIENT CIRCUITS .................................................D-2
INFANT/PEDIATRIC, SINGLE-LIMB, WYE PATIENT CIRCUITS ................................................D-8
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This chapter provides general information about the ZOLL ventilator and the ZOLL Ventilator
Operator’s Guide, which we provide with this product. Specifically, this chapter provides
• A brief desc ription of the ZOLL Ventilator.
• Information about this manual (ZOLL Ventilator Operator’s Guide).
• A table th at desc ri bes the symbols that appear on the ventilator and in this manual.
• The ZOLL Ventilator’s Indications for Use.
• A list of Warnings and Cautions regarding the use of the ventilator.
• Information regarding FDA tracking requirements, and the product’s warranty and software
license.
• How to contact ZOLL Medical Corporation for service to this product .
Product Description
The ZOLL Ventilator is a small, extremely durable, full-featured portable mechanical ventilator
designed to operate in hospitals or severe and under-resourced environments. It can be used in
prehospital, field hospital and hospital settings.
Chapter 1
General Information
How to Use this Manual
The ZOLL Ventilator Operat or’s Guide provides information that operators need for the safe
and effective use and care of the ventilator. It is import ant that all persons using this device rea d
and understand all the information contained within.
Please throughly read the warnings section.
Procedures for unit care are located in Chapter 7, “Maintenance”.
906-0731-01-05 Rev. B ZOLL Ventilator Operator’s Guide 1-1
GENERAL INFORMATION
Operator’s Guide Updates
An issue or revision date for this manual is sh own on the front cove r. If more than 3 years have
elapsed since this date, contact ZOLL Medical Corporation to determine if additional product
information updates are available.
All users should carefully review each manual update to understand its significance and then
file it in its appropriate section within this manual for subsequent reference.
Product documentation is available through the ZOLL website at www.zoll.com. From the
Products menu, choose Product Manuals.
Unpacking
Carefully inspect each container for damage. If the shipping container or cushion material is
damaged, keep it until the contents have been checked for completeness and the instrument has
been checked for mechanical and electrical integrity. If the contents are incomplete, if there is
mechanical damage, or if the ventilator doe s not pass its Self Test, U.S.A. customers should call
ZOLL Medical Co rporation (1 -978-421-965 5). Customers out side of the U .S.A. should co ntact
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 you attach the breathing circuit to begin ventilation using either
internal or external power. Both the ventilator and breathing circuit are supplied clean and are
ready for use on a patient.
Symbols on the Ventilator
The following symbols appear on the ventilator or in this manual:
Symbol Description
Off
On
Direct Current: Identifies the location to connect external DC Power.
Mute / Cancel: Identifies button which mutes the active alarms or cancels
the parameter selection.
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Symbol Description
Accept / Confirm: Identifies button which accepts the parameter
selection.
ESD: Warns that connector pins should not be touched.
Identifies the dial that allows the selection of parameter values.
Do Not Re-Use: This item should not be re-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.
Defibrillation Proof: Indicates the degree of protection against electrical
shock.
BF Symbol: Protection against electric shock, Type B with floating
(F-type) parts.
MR Symbol: Identifies the use of the device’s ability to perform in a MRI
environment.
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.
906-0731-01-05 Rev. B ZOLL Ventilator Operator’s Guide 1-3
GENERAL INFORMATION
280 - 600 kPa
(40 - 87 PSIG)
O
2
NOT OCC
Symbol Description
Consult Instruction: Consult the instructions for use or operation manual.
Refer to instruction manual.
Menu icon. This icon identifies the button that, when pressed, displays a
menu of options that you can select to configure the ventilator.
High Pressure O
Connector (top faceplate icon).
2
Exhalation Valve (top faceplate icon).
Exhaust Do Not Occlude (top faceplate icon).
Transducer (top faceplate icon).
Gas Output -- Patient Circuit Connector (top faceplate icon).
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Symbols on the Ventilator’s Graphical User Interface (GUI)
+
LC
LC
_ _ _
_ _
The following symbols appear on the ventilator’s Graphical User Interface (GUI):
Symbol Description
Heart: Provides indication that the pulse oximeter is in use.
Alarm Bell: Identifies the number of off-screen alarms
Alarm Bell Outline: Identifies alarm limit settings; Identifies the on-screen
alarms.
O2 reservoir mode is in use.
Leak Compensation (LC) feature is ON.
Leak Compensation Feature is OFF.
Patient Detect Mode: Backup Ventilation Started.
Not receiving a reading.
Attention: High Priority Alarm Active.
Caution: Medium Priority Alarm Active.
906-0731-01-05 Rev. B ZOLL Ventilator Operator’s Guide 1-5
GENERAL INFORMATION
EXT
BATT
off
on
Symbol Description
Warning: Low Priority Alarm Active.
Mute: Active Alarm Audible Signal Muted.
Speaker: Active Alarm Audible Signal
Oxygen Supply: Oxygen Supply Connected.
External Power: Indicates the 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.
Indicates that an external battery is powering the ventilator.
No Internal Battery: Indicates when internal battery is not an available
power source.
Head with Mask: the unit is in Non-invasive Positive Pressure Ventilation
(NPPV) mode.
Feature OFF -- feature or alarm not selected.
Feature ON -- feature or alarm has been selected.
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Symbol Description
srch
stby
Conventions
This guide uses the following conventions:
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).
Search
Standby.
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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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 O
BiPAP- Bilevel positive airway pressure P
BPM - Breaths per Minute PEEP - Positive End Expiratory Pressure
cm H
O - Centimeters of Water PIP - Peak Inspiratory Pressure
2
CPAP- Continuous Positive Airway Pressure PPV- Positive-Pressure Ventilation
CPR - Cardiopulmonary Resuscitation PS- Pressure support
CPU- Central Processor Unit psig - Pounds per Square Inch Gage
dBA- Decibel RF- Radio Frequency
DISS - Diameter Index Safety System RGA #- Returned-Goods-Authorization number
EMC- Electromagnetic Compatibility RTC- Real time clock
EMV- Emergency Medical Ventilator SIMV- Synchronized Intermittent Mandatory
ESD- Electrostatic Discharge SPM- Smart Pneumatic Module
FIO
Fraction of Inspired Oxygen USP - United States Pharmacopeia
2 -
HME - Heat and Moisture Exchanger VAC - Volts AC
HMEF - Heat and Moisture Exchanger/Bacterial Viral
filter combined
- oxygen
2
- Airway Pressure
aw
Ventilation
VDC - Volts DC
HP O
- High Pressure Oxygen VT -
2
Hz – Hertz (as in frequency, cycles per second) WOB – Work Of Breathing
Tidal Volume
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ZOLL Ventilator Indications for Use
Ventilation
Each model of the ZOLL 731 Series of Ventilato rs is i ndicated for use in the management of
infant through adult patients weighing greater than or equal to 5 kg with acute or chronic
respiratory failure or during resuscitation by providing continuous positive-pressure
ventilation. ZOLL Ventilators are appropriate for use in hospitals, outside the hospital, during
transport and in severe environments where they may be expo sed to rai n, du st, rough handli ng,
and extremes in temperature and humidity. With an appropriate third-party filter in place, they
may be operated in environments where chemical and/or biological toxins are present. When
marked with an "MRI conditional" label, ZOLL Ventilators are suitable for use in an MRI
environment with appropriate precautions. ZOLL Ventilators are not intended to operate in
explosive environments. ZOLL Ventilators are intended for use by skilled care providers with
knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a
basic knowledge of mechanical ventilation, and by first responders under th e direction of
skilled medical care providers
Pulse Oximetry (SpO2)
The ZOLL Ventilator pulse oximeter with Masimo Rainbow® SET technology is intended for
use for continuous noninvasive monitoring of functional oxygen saturation of arterial
hemoglobin (SpO
use on adult, pediatric, and ne onatal patie nts during both no moti on and motio n conditio ns, and
for patients who are well or poorly perfused, in hospitals, hospital-type facilities, or in mobile
environments.
), and pulse rate. The pulse SpO2 oximeter and accessories are indicated for
2
906-0731-01-05 Rev. B ZOLL Ventilator Operator’s Guide 1-9
GENERAL INFORMATION
Features
• Portable ventilator that you can use 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 -- less than 10 lbs (4.4 kg) -- for easy transport.
• Rechargeable battery provides over 10 hours of operation (at factory default with pulse
oximeter operating).
• Operating temperature range for extreme conditions: -25 to 49C.
• 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 hi gh and low- pressure o xy gen source s. 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
Ventilator
• The ZOLL Ventilator is intended for use by qualified personnel only. You should read this
manual before using the device.
• Before using the ventilator on a patient, you must test the dev ice in its normal co nfiguratio n
to ensure proper operation .
• Do not modify this equipment without authorization of the manufacturer.
• This operator’s guide is not meant to supersede any controlling operating procedure
regarding the safe use of assisted ventilation.
• Follow all governing regulations regarding the disposal of any part of this medical device,
the handling of materials contaminated by body fluids, and shipment of th e Li-ION
batteries.
• The ZOLL Ventilator can operate from its internal battery or from an e xternal po wer source.
When using an external power source, position the supply cables to avoid accidental
disconnect.
• The use of accessories and cables other than those sold by ZOLL may result in increased
emissions or decreased immunity of this device.
• Portable and mobile RF communication equipment may affect the performance of this
device. We describe the EMC performance for this device in the Specifications section of
this operator’s guide.
• The ventilator may cause radio interference or may disrupt the operation of nearby
equipment. It may be necessary to take mitigation measures, such as re-orienting or
relocating of the device or shielding the location.
• Do not connect to an electrical outlet controlled by a wall switch or dimmer.
• The protection against defibrillator depends on the use of accessories (including pulse
taximeter) that are specified by ZOLL.
• Grounding:
• Do not under any circumstances remove t he grounding conductor from the power
plug.
• Do not use extension cords or adapters of any type. The power cord and plug must
be intact and undamaged.
• If there is any doubt about the integrity of the protective earth conductor
arrangement, operate the taximeter on internal battery power until the AC power
supply protective cover is fully functional.
• As with all medical equipment, carefully route the ventilator circuit, patient cabling, and
external power cables to reduce the possibility of patient entanglement or strangulation.
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GENERAL INFORMATION
• Do not use the unit during magnetic resonance imaging (MRI) scanning unless it has the
appropriate “MRI conditional” label. See “Using the ZOLL Ventilator in an MRI
Environment” for instructions on the use of MRI conditional units, which gives additional
Warnings and Cautions.
• Do not operate the ZOLL Ventilator on a patient when the USB port is connected to any
other device (you use the USB port only for servicing the ventilator).
• The ZOLL-supplied ventilator circuit’s labeling provides the resistance and compliance
values for the circuits under normal operating conditions. If added accessories are used
(e.g. humidification, filters etc.), you should assure they do not degrade the performance of
the device.
Pulse Oximeter
• Do not use the pulse oximeter as an apnea monitor.
• A pulse oximeter should be considered an early warning device. As a trend towards patient
deoxygenation is indicated, blood samples should be analyzed by a laboratory co-oximeter
to completely understand the patient’s condition.
• Measurements: if the accuracy of any measurement does not seem reasonable, first check
the patient’ s vital signs by alternate means and then check the pulse oximeter for proper
functioning.
Inaccurate measurements may be caused by:
• Interfering Substances: carboxyhemoglobin may erroneously increase readings. The level of
increase is approximately equal to the amount of carboxyhemoglobin present. Dyes, or any
substance containing dyes, that change usual arterial pigmentation may cause erroneous
readings.
• Alarms: Check alarm limits each time the pulse oximeter is used to ensure that they are
appropriate for the patient being monitored.
• Incorrect sensor application or use.
• Significant levels of dysfunctional hemoglobin (e.g. carboxyhemoglobin or
methemoglobin).
• Intravascular dyes such as indocyanine green or methylene blue.
• Exposure to excessive illumination, such as surgical lamps (especially ones with a
xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, or
direct sunlight (exposure to excessive illumination can be corrected by c overing the
sensor with a dark or opaque material).
• Excessive patient movement.
• Venous pulsations.
• Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter,
or intravascular line.
• The pulse oximeter can be used during defibrillation, but the readings may be
inaccurate for a short time.
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• Loss of pulse signal can occur in any of the following situations:
• The sensor is too tight.
• Excessive illumination from light sources such as a surgical lamp, a Ru bin lamp, or
sunlight.
• A blood pressure cuff is inflated on the same extremity as the one with an SpO
2
sensor attached.
• The patient has hypotension, severe vascoconstriction, severe anemia, or
hypothermia.
• Arterial occlusion proximal to the sensor.
• The patient is in cardiac arrest or is in shock.
• Sensors:
• Before use, carefully read the LNCS
• Use only Masimo oximetry sensors for SpO
®
sensor directions for use.
measurements. Other oxygen
2
transducers (sensors) may cause improper performance.
• Tissue damage can be caused by incorrect application or use of an LNCS
®
sensor
for example, by wrapping the sensor too tightly. Inspect the sensor site as directed
in the sensor Directions for Use to ensure skin integrity and correct positioning
and adhesion of the sensor.
• Do not damage LNCS
®
sensors. Do not use an LNCS® sensor with exposed optical
components. Do not immerse the sensor in water, solvents, or cleaning solutions
(The sensors and connectors are not waterproof). Do not sterilize by irradiation,
steam, or ethylene oxide. See the cleaning in structions in the direct ions for reusable
®
Masimo LNCS
• Do not use damaged patient cables. Do not immerse the patient cables in water,
sensors.
solvents, or cleaning solutions (the patient cables are not waterproof). Do not
sterilize by irradiation, steam, or ethylene oxide. See the cleaning instructions in
the directions for reusable Masimo patient cables.
• Do not use the pulse oximeter sensor during magnetic resonance imaging (MRI) scanning.
Inducing current could potentially cause burns. The pulse oximeter may affect the MRI
image and the MRI unit may affect the accuracy of the dosimetry measurements.
Batteries
• Only use the Power Supply provided with the device. Use of any other power supp ly could
cause damage or create a fire and/or destroy the battery and unit.
• If you witness a battery or the battery c ompartment 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 punctu re or
disassemble the battery packs or cells.
Operator Safety
• Electric shock hazard: Do not remove equipment covers. You may only perform
maintenance procedures specifically described in this manual. Refer all servicing to
ZOLL or a ZOLL-authorized service center.
• Possible explosion hazard if used in the presence of flammable anesthetics or other
flammable substances in combination with air, oxygen-enriched environments, or ni trous
oxide.
• This device is not intended for use in explosive atmospheres.
• Pins of connectors identified with the ESD warning symbol should not be touched. Always
use precautionary procedures with ESD-sensitive connection s.
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GENERAL INFORMATION
Patient Safety
• To ensure patient electrical isolation, connect only to other equipment with electronically
isolated circuits.
• Do not place the 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
taximeter patient cable.
• Never service the ventilator while in use with a patient.
Ferromagnetic Equipment
• Failure to follow all instructions can result in MRI artifacts, injury to the patient or
operator, or malfunction of the device.
• You must follow all safety procedures that are in effect for the MRI Environment. Do
not use the ventilator in an MRI Environment with greater than 3T magnetic force.
• You must secure the unit to a suitable MRI-compatible cart -- ZOLL MRI Roll
Stand (REF 816-0731-01); Optional IV Arm Assembly (REF 707-0731-09).
• You must place the ventilator behind the 2000 Gauss field line -- approximately 2
meters to the bore opening of the MRI magnet.
• The ventilator must be attended by a person with no other responsibility than
monitoring the device and patient while in the MRI Environment.
• You must visually mo n itor the ventilator for alarms at all times -- during imaging,
the alarms may not be audible beyond the area immediately adjacent to the MRI.
• Danger! Possible Missile Projection.
• DO NOT position any person between the bore entrance and an unsecured cart or
device.
• Lock the wheels when the rolling stand is in place.
• We recommend that you tether the rolling stand in place when in the MRI
Environment.
• Place the ventilator and stand in its position before the patient is positioned on the
scanner table and advanced into the bore.
• Remove the patient from the MRI Environment before removing the ventilator and
roll stand.
• Unapproved device apparatus shall NOT be allowed in the MRI Environment,
including:
• Pulse Oximeters sensors and cabling.
• External AC/DC Power Supply.
• Rolling Cart Breathing Circuit Arm.
• Active Humidification and associated support apparatus.
• Ensure proper configuration of the ventilator.
• DO NOT attach the pulse oximeter sensor to the patient and remove it from the
device.
• The ventilator should run only on battery power in the MRI Environment
-- DO NOT use an external AC/DC power supply.
• The ventilator’s battery should be fully charged before entering the MRI
Environment.
• Oxygen Supply -- an aluminum, non-magnetic cylinder must provide the oxygen
supply.
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Cautions
• Ensure proper operation of the ventilator’s breathing system.
• 12 ft ventilator circuits are available for use with the ventilator -- the additional
length enables a suitable separation between the ventilator and the bore opening.
(REF 820-130-00 -- Adul t/Ped iatric Wy e Ventilator Circuit; REF 820-131-00 -Pediatric/Infant Wye Ventilator Circuit).
• The extended tubing length of a 12 ft ventilator circuit can result in loss of volume
due to additional compressibility.
-- Set the Tubing Compliance (TC) to OFF and ensure that the patient is
receiving correct tidal volume.
-- Alternatively, calculate the TC as described by the ventilator circuit’s
Instructions For Use (IFU) and adjust the TC value to ensure that the patient is
receiving the correct tidal volume.
• DO NOT use the 12 ft circuit with settings below 5 cmH20.
• Ensure that the ventilator is able to maintain PEEP -- for patients with short
expiratory times, the additional tubing length of the 12 ft circuit may affect system
behavior.
• Inspect the circuit very day to ensure that there is no damage or wear that could affect its
performance. Remove Fluid or other biological material from the circuit or replace the
circuit following the local standard of care.
• Federal law restricts this device to sale by or on the order of a physician.
• Only qualified biomedical equipment technicians should service the device.
• Internal components are susceptible to damage from static discharge. Do not remove device
covers.
• Possession or purchase of this device does not convey any expressed or implied license to
use the device with unauthorized sensors or cables which would, alone, or in combination
with this device fall within the scope of one or more of the patients related to this device.
ZOLL cannot ensure the proper functioning of this device if it is used with unauthorized
sensors, cables, or patient circuits.
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GENERAL INFORMATION
FDA Tracking Requirements
U.S. Federal Law (21 CFR 821) requires the tracking of ventilators. Under this law, owners
of this ventilator must notify ZOLL Medical Corporation if this product is
• received
• lost, stolen, or destroyed
• donated, resold, or otherwise distributed to a different organization
If any such event occurs, contact ZOLL Medical Corporation in writing with the following
information:
1. Originator's organization – Company name, address, contact name, and contact phone
number
2. Model number, and serial number of the ventilator
3. Disposition of the ventilator (for example, received, lost, stolen, destroyed, distributed to
another organization), new location and/or organization (if known and different from
originator’s organization) – company name, address, contact name, and contact phone
number
4. Date when the change took effect
Please address the information to:
ZOLL Medical Corporation
Attn: Tracking Coordinator
269 Mill Road
Chelmsford, MA 01824-04105
Fax: (978) 421-0007
Telephone: (978) 421-9655
Notification of Adverse Events
As a health care provider, you may have responsibilities under the Safe Medical Devices Act
(SMDA), for reporting to ZOLL Medical Corporation, and possibly to the FDA, the occurrence
of certain events.
These events, described in 21 CFR Part 803, include device-related death and serious injury or
illness. In addition, as part of our Quality Assurance Program, ZOLL Medical Corporation
requests to be notified of device failures or malf unctions. This information is required to ensure
that ZOLL Medical Corporation provides only the highest quality pro ducts.
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Software License
Note: Read this Operator’s Guide and License agreement carefully before operating any of
the 731 Series Ventilator products.
Software incorporated into the system is protected by copyright laws and international
copyright treaties as well as other intellectual property laws and treaties. This software is
licensed, not sold. By taking delivery of and using this system, the Purchaser signifies
agreement to and acceptance of the following terms and conditions:
1. Grant of License: In consideration of payment of the software license fee which is part of
the price paid for this product, ZOLL Medical Corporation grants the Purchaser a
nonexclusive license, without right to sublicense, to use the system software in object-code
form only.
2. Ownership of Software/Firmware: Title to, ownership of, and all rights and interests in the
system software and all copies thereof remain at all times vested in the manufacturer, and
Licensors to ZOLL Medical Corporation and they do not pass to purchaser.
3. Assignment: Purchaser agrees not to assign, sublicense, or otherwise transfer or share its
rights under the license without the express written permission of ZOLL Medical
Corporation.
4. Use Restrictions: As the Purchaser, you may physically transfer the products from one
location to another provided th at the soft ware/firmware i s not cop ied. 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.
906-0731-01-05 Rev. B ZOLL Ventilator Operator’s Guide 1-17
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 amoun t of th e pu rcha se price (on the date sold
by ZOLL). To qualify for such repair, replacement, or refund, the defective device must be
returned to the ZOLL Service Center within thirty (30) days from the date that the defect is
discovered. This warranty does not apply if the device has been repaired or modified without
the authorization of ZOLL or if the damage was caused by incorrect (off-label) use, negligence,
or an accident.
Batteries, which by their nature are consumable and subjected to environmental extremes, will
be warranted only for a period of ninety (90) days. Accessories, also consumable in usage, such
as connecting hose and breathing circuits, are not warranted.
DISCLAIMER OF IMPLIED & OTHER WARRANTIES:
THE PRECEDING WARRANTY IS THE EXCLUSIVE WARRANTY AND ZOLL
MAKES NO OTHER WARRANTY OR REPRESENTATION OF ANY KIND
WHATSOEVER, EXPRESS OR IMPLIED, WITH RESPECT TO MERCHANTABILITY,
FITNESS FOR A PARTICULAR PURPOSE, OR ANY OTHER MATTER. THE
REMEDIES STATED IN THIS DOCUMENT WILL BE THE EXCLUSIVE REMEDIES
AVAILABLE TO THE CUSTOMER FOR ANY DEFECTS OR FOR DAMAGES
RESULTING FROM ANY CAUSE WHATSOEVER AND WITHOUT LIMITATION.
ZOLL WILL NOT IN ANY EVENT BE LIABLE TO THE CUSTOMER FOR
CONSEQUENTIAL OR INCIDENTAL DAMAGES OF ANY KIND, WHETHER FOR
DEFECTIVE OR NONCONFORMING PRODUCTS, BREACH OR REPUDIATION OF
ANY TERM OR CONDITION OF THIS DOCUMENT, NEGIGENCE, OR ANY OTHER
REASON.
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Service
If a unit requires service, contact the ZOLL Technical Service Department.
For customers In the U.S.A. For customers outside the U.S.A.
Telephone:
Fax:
1-973-882-1212
1-978-421-0010
Call the nearest authorized ZOLL Medical Corporation
representative.
To locate an authorized service center, contact the
International Sales Department at
ZOLL Medical Corporation
269 Mill Road
Chelmsford, MA 01824
Telephone: 1-978-421-9655
When requesting service, please provide the following information to the service
representative:
• 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 return
authorization form. Pack the unit with its cables in the original containers (if availabl e) 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
269 Mill Road
Elmsford, MA 01824
Attention: Technical Service Department (SR number)
Telephone: 1-978-421-9655
In Canada ZOLL Medical Canada Inc.
1750 Sismet Road, Unit #1
Mississauga, ON L4W 1R6
Attention: Technical Service Department (SR number)
Telephone: 1-866-442-1011
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GENERAL INFORMATION
For customers Return the 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
This chapter provides an overview of the ZOLL Ventil ator, which you can use to manage infa nt
through adult patients with acute or chronic respiratory failure or pat ients that you are
resuscitating by providing continuous positive-pressure ventilation. (See Indications for Use
in Chapter 1.)
This chapter describes the ZOLL Ventilator models, providing a list of common features and
attributes, as well as descriptions of each model. This chapter also provides more detailed
descriptions of the following ventilator features:
• Controls and Indicators
• Display Screen
• Pneumatic Design
• Fresh Gas Intake
• Connector Panel
• Ventilator Circuits
• Pulse Oximeter
• Power Sources
906-0731-01-05 Rev. B ZOLL Ventilator Operator’s Guide 2-1
PRODUCT OVERVIEW
ZOLL Ventilator Models
The ZOLL Ventilator is available as the AEV, EMV+, and Eagle II models. The ventilator
offers a range of ventilatory modes to support EMS, military, air transport, and hospital
transport needs.
The AEV ventilator is designed for managing ventilator support patients during ambulance
transport. Its ventilation modes (AC, CPAP with PS, and BL) are specifically chosen to be
consistent with pre-hospital care provider's operating procedures.
The EMV+ ventilator's rugged design makes it ideal for use in emergency vehicle and air
transport of patients. It has a wide range of ventilation modes, such as AC, SIMV, CPAP, and
BL.
The Eagle II ventilator adapts the design of for the EMV+ for use by emergency departments
and intra-hospital transport. Its design also allows it to be mounted on to walls or onto specified
boom arms and roll stands as well as gurneys.
The ZOLL ven tila t o r s have been approved for use in MR I suites. The EMV+ and Eagle II
ventilators have MRI-compatible variants available. The MRI-compatible ventilators can
operate in 3.0 Tesla environments and can be placed approximately 6 1/2 ft. from the bore
opening for easy and safe access to the patient. See Chapter 3 for more information regarding
safe operation in the MRI Environment.
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ZOLL Ventilator Features
The ZOLL Ventilator models have these common features:
• Rugged design
• Weight: ~10 lbs
• 10 hour battery life
• Rapid charger to achieve 90% battery capacity in 2 hours
• High performance internal compressor
• Smart Help messages
• Integral SpO
• Airworthiness Release
• Daylight visible display
• Oxygen efficient
• Supports infant, pediatric, and adult patients
• Limited 1 year warranty
(Masimo)
2
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PRODUCT OVERVIEW
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2
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10
6
7
8
9
11
ZOLL Ventilator Device Description
The following illustration shows the ZOLL Ventilator’s main features:
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