731 Series Models EMV+, AEV and Eagle II Operators Guide Rev C Jan 2018

The issue date for the ZOLL Ventilator Operator’s Guide (REF 906-0731-01-05 Rev. C) is January, 2018. Copyright © 2018 ZOLL Medical Corporation. All rights reserved. ZOLL, AEV, EMV+, Eagle II, and Smart Help are trademarks or registered trademarks of ZOLL Medical Corporation in the United States and/or other countries. All other trademarks are the property of their respective owners.

Masimo Pulse Oximeter This device uses Masimo SET® technology to provide continuous pulse oximeter and heart rate monitoring and is covered under one or more of the following U.S.A. patents: 5,758,644, 5,823,950, 6,011,986, 6,157,850, 6,263,222, 6,501,975 and other applicable patents listed at www.masimo.com/patents.htm.

Limited Copyright Release Permission is hereby granted to any military/governmental agency to reproduce all materials furnished herein for use in a military/governmental service training program and/or other technical training program.

ZOLL Medical Corporation 269 Mill Road Chelmsford, MA USA 01824-4105 ZOLL International Holding B.V. Newtonweg 18 6662 PV ELST The Netherlands

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Contents

Chapter 1

General Information

Product Description ... 1 How to Use this Manual ... 1 Operator’s Guide Updates ... 2 Unpacking ... 2 Assembly ... 2 Symbols on the Ventilator ... 2 Symbols on the Ventilator’s Graphical User Interface (GUI)... 5 Conventions ... 7 Abbreviations ... 8 ZOLL Ventilator Indications for Use ... 9 Ventilation ... 9 Pulse Oximetry (SpO2) ... 9 Features ... 10 Warnings...11 General ... 11 Ventilator ... 11 Pulse Oximeter ... 12 Batteries ... 13 Operator Safety ... 13 Patient Safety ... 14 Ferromagnetic Equipment ... 14 Cautions ... 15 FDA Tracking Requirements... 16 Notification of Adverse Events ... 16 Software License ... 17 Limited Warranty ... 18 Service... 19

Chapter 2

Product Overview

ZOLL Ventilator Models ... 2 ZOLL Ventilator Features... 3 ZOLL Ventilator Device Description ... 4 Controls and Indicators ... 6

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Display Screen... 7 Message Area ... 7 Parameter Windows ... 7 Shared Icon Area ... 8 Auxiliary Parameter Boxes ... 8 Pneumatic Design... 9 Fresh Gas Intake and Attachments ... 10 Top Panel ... 10 Oxygen Input: High Pressure Gas Supply ... 11 Ventilator Circuits ... 12 Ventilator Circuit Types ... 14 Pulse Oximeter Sensors ... 15 Power Sources ... 15 Operating Using External DC Power ... 15 Operating Using Battery Power ... 15

Chapter 3

Setting Up the ZOLL Ventilator

1. Attach the Ventilator Circuit... 2 2. Attach the High Pressure Oxygen Supply (Optional)... 3 3. Inspect Fresh Gas Intake Filters ... 3 4. Connect Fresh Gas Intake Attachments ... 4 5. Select the Ventilator’s Power Source... 5 Connecting the Power Supply ... 6 6. Power On the Ventilator ... 7 7. Select Start Up Default Values... 8 8. Select Operating Mode (Optional) ... 10 9. Change Parameter Values...11 10. Change Ventilator Settings ...11 11. Perform Operational Test ... 12 12. Attach the Pulse Oximeter Probe (Optional)... 13 13. Attach Patient... 13

Chapter 4

Using the ZOLL Ventilator

The Ventilator Interface... 2 Changing Parameter Values ... 2 Parameter Buttons ... 2 Mode... 2 Breath Target ... 4 Leak Compensation ... 4 BPM (Breathes Per Minute) -- Timing and Rate Management ... 5 Control Parameter ... 5 Rise Time ... 5 BPM Parameter Settings ... 7 Vt (Tidal Volume) ... 8

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PIP (Peak Inspiratory Pressure) -- Pressure Management ... 9 Spontaneous/Assisted Breath Trigger ... 9 Plateau Pressure ... 10 Pressure Management ... 11 FIO2 (Fraction of Inspired Oxygen) -- Oxygen Delivery Management... 12 SpO2 -- Using the Pulse Oximeter... 13 SpO2 Parameter Values ... 14 HR (Heart Rate) ... 16 Managing Pop Up Messages... 17 Managing Alarms ... 18 Smart Help Messages ... 19 Alarm Priorities ... 20 Silencing Alarms ... 21 Turning Off Alarms at Extreme Range Limits ... 22 Alarm Cancellation in Alarm Configuration Menu ... 23

Chapter 5

Alarms

Alarm Overview ... 2 Alarm Priorities ... 4 Muting Alarms ... 5 Alarms Types ... 5 Alarm Groups... 6 High Priority Alarms ... 8 Medium Priority Alarms... 12 Low Priority Alarms ... 18 Pop Up Messages ... 26

Chapter 6

Operating Environments

Using the ZOLL Ventilator in Harsh Environments ... 1 Airborne Particulates ... 1 Extreme Temperature Environments ... 2 Altitude ... 3 Rain and Snow ... 4 Using the ZOLL Ventilator in Hazardous Environments... 4 Using the ZOLL Ventilator in an MRI Environment ... 7

Chapter 7

Maintenance

Inspecting the ZOLL Ventilator ... 1 Cleaning... 2 Post-Contaminated Environment Cleaning ... 3 Gas Intake Filters... 3 Inspecting and Replacing the Foam Filter ... 3 Inspecting and Replacing the Disk Filter ... 3

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Replacing the ZOLL Ventilator’s Filters ... 4 Replacing the Foam Filter ... 4 Replacing the Disk Filter ... 5 Battery Maintenance ... 5 Battery Storage ... 7 Ventilator Storage ... 8 Battery Replacement and Shipping Regulations ... 8 Calibration Checks... 8 Electrical Safety Check ... 8 Troubleshooting ... 9

Appendix A Specifications General ... 1 Pulse Oximeter ... 3 Device Classification... 4

Appendix B Accessories Appendix C Pulse Oximeter Principles Appendix D Patient Circuits Pediatric/Adult, Single-Limb, Wye Patient Circuits ... 2 Intended Use -- Pediatric/Adult Patient Circuits ... 2 Specifications ... 2 Directions for Use -- Pediatric/Adult Patient Circuits ... 4 Troubleshooting -- Pediatric/Adult Patient Circuits ... 5 Infant/Pediatric, Single-Limb, Wye Patient Circuits... 8 Intended Use ... 8 Specifications ... 8 Directions for Use -- Infant/Pediatric Patient Circuits ... 10 Troubleshooting -- Infant/Pediatric Patient Circuits ... 11

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Chapter 1 General Information This chapter provides general information about the ZOLL ventilator and the ZOLL Ventilator Operator’s Guide, which we provide with this product. Specifically, this chapter provides A brief description of the ZOLL Ventilator. Information about this manual (ZOLL Ventilator Operator’s Guide). A table that describes the symbols that appear on the ventilator and in this manual. The ZOLL Ventilator’s Indications for Use. A list of Warnings and Cautions regarding the use of the ventilator. Information regarding FDA tracking requirements, and the product’s warranty and software license. • How to contact ZOLL Medical Corporation for service to this product. • • • • • •

Product Description The ZOLL Ventilator is a small, extremely durable, full-featured portable mechanical ventilator designed to operate in hospitals or severe and under-resourced environments. It can be used in prehospital, field hospital and hospital settings.

How to Use this Manual The ZOLL Ventilator Operator’s Guide provides information that operators need for the safe and effective use and care of the ventilator. It is important that all persons using this device read and understand all the information contained within. Please throughly read the warnings section. Procedures for unit care are located in Chapter 7, “Maintenance”.

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GENERAL INFORMATION

Operator’s Guide Updates An issue or revision date for this manual is shown on the front cover. If more than 3 years have elapsed since this date, contact ZOLL Medical Corporation to determine if additional product information updates are available. All users should carefully review each manual update to understand its significance and then file it in its appropriate section within this manual for subsequent reference. Product documentation is available through the ZOLL website at www.zoll.com. From the Products menu, choose Product Manuals.

Unpacking Carefully inspect each container for damage. If the shipping container or cushion material is damaged, keep it until the contents have been checked for completeness and the instrument has been checked for mechanical and electrical integrity. If the contents are incomplete, if there is mechanical damage, or if the ventilator does not pass its Self Test, U.S.A. customers should call ZOLL Medical Corporation (1-978-421-9655). Customers outside of the U.S.A. should contact the nearest ZOLL authorized representative. If the shipping container is damaged, also notify the carrier. If there is no apparent sign of mechanical damage, read instructions contained within this manual before attempting operation.

Assembly The 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.

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GENERAL INFORMATION 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.

280 - 600 kPa High Pressure O2 Connector (top faceplate icon). O2 (40 - 87 PSIG)

HAUST NOT OCC

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) 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.

LC

Leak Compensation (LC) feature is ON.

LC

Leak Compensation Feature is OFF.

___

Patient Detect Mode: Backup Ventilation Started.

__

Not receiving a reading.

Attention: High Priority Alarm Active.

Caution: Medium Priority Alarm Active.

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GENERAL INFORMATION 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.

EXT BATT

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.

off on

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Feature OFF -- feature or alarm not selected.

Feature ON -- feature or alarm has been selected.

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Symbol

Description

srch

Search

stby

Standby.

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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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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ZOLL Ventilator Indications for Use Ventilation Each model of the ZOLL 731 Series of Ventilators is indicated for use in the management of infant through adult patients weighing greater than or equal to 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. ZOLL Ventilators are appropriate for use in hospitals, outside the hospital, during transport and in severe environments where they may be exposed to rain, dust, rough handling, and extremes in temperature and humidity. With an appropriate third-party filter in place, they may be operated in environments where chemical and/or biological toxins are present. When marked with an "MRI conditional" label, ZOLL Ventilators are suitable for use in an MRI environment with appropriate precautions. ZOLL Ventilators are 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 the direction of skilled medical care providers

Pulse Oximetry (SpO2) The ZOLL Ventilator pulse oximeter with Masimo Rainbow® SET technology is intended for use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), and pulse rate. The pulse SpO2 oximeter and accessories are indicated for use on adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, or in mobile environments.

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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 • • • • • • • • •

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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 49C. 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 • The ZOLL Ventilator is intended for use by qualified personnel only. You should read this • • • •

manual before using the device. Before using the ventilator on a patient, you must test the device in its normal configuration to ensure proper operation. Do not modify this equipment without authorization of the manufacturer. This operator’s guide is not meant to supersede any controlling operating procedure regarding the safe use of assisted ventilation. Follow all governing regulations regarding the disposal of any part of this medical device, the handling of materials contaminated by body fluids, and shipment of the Li-ION batteries.

Ventilator • The ZOLL Ventilator can operate from its internal battery or from an external power source.

• •

•

• • •

•

When using an external power source, position the supply cables to avoid accidental disconnect. The use of accessories and cables other than those sold by ZOLL may result in increased emissions or decreased immunity of this device. Portable and mobile RF communication equipment may affect the performance of this device. We describe the EMC performance for this device in the Specifications section of this operator’s guide. The ventilator may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating of the device or shielding the location. Do not connect to an electrical outlet controlled by a wall switch or dimmer. The protection against defibrillator depends on the use of accessories (including pulse taximeter) that are specified by ZOLL. Grounding: • Do not under any circumstances remove the grounding conductor from the power plug. • Do not use extension cords or adapters of any type. The power cord and plug must be intact and undamaged. • If there is any doubt about the integrity of the protective earth conductor arrangement, operate the taximeter on internal battery power until the AC power supply protective cover is fully functional. As with all medical equipment, carefully route the ventilator circuit, patient cabling, and external power cables to reduce the possibility of patient entanglement or strangulation.

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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: • 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.

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• Loss of pulse signal can occur in any of the following situations: • The sensor is too tight. • Excessive illumination from light sources such as a surgical lamp, a Rubin lamp, or

sunlight. A blood pressure cuff is inflated on the same extremity as the one with an SpO2 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® 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. • 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 sensor during magnetic resonance imaging (MRI) scanning. Inducing current could potentially cause burns. The pulse oximeter may affect the MRI image and the MRI unit may affect the accuracy of the dosimetry measurements. •

Batteries • Only use the Power Supply provided with the device. Use of any other power supply could

cause damage or create a fire and/or destroy the battery and unit.

• 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.

Operator Safety • Electric shock hazard: Do not remove equipment covers. You may only perform

maintenance procedures specifically described in this manual. Refer all servicing to ZOLL or a ZOLL-authorized service center. • Possible explosion hazard if used in the presence of flammable anesthetics or other flammable substances in combination with air, oxygen-enriched environments, or nitrous oxide. • This device is not intended for use in explosive atmospheres. • Pins of connectors identified with the ESD warning symbol should not be touched. Always use precautionary procedures with ESD-sensitive connections.

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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 monitor the ventilator for alarms at all times -- during imaging, the alarms may not be audible beyond the area immediately adjacent to the MRI. • Danger! Possible Missile Projection. • DO NOT position any person between the bore entrance and an unsecured cart or device. • Lock the wheels when the rolling stand is in place. • We recommend that you tether the rolling stand in place when in the MRI Environment. • Place the ventilator and stand in its position before the patient is positioned on the scanner table and advanced into the bore. • Remove the patient from the MRI Environment before removing the ventilator and roll stand. • Unapproved device apparatus shall NOT be allowed in the MRI Environment, including: • Pulse Oximeters sensors and cabling. • External AC/DC Power Supply. • Rolling Cart Breathing Circuit Arm. • Active Humidification and associated support apparatus. • Ensure proper configuration of the ventilator. • DO NOT attach the pulse oximeter sensor to the patient and remove it from the device. • The ventilator should run only on battery power in the MRI Environment -- DO NOT use an external AC/DC power supply. • The ventilator’s battery should be fully charged before entering the MRI Environment. • Oxygen Supply -- an aluminum, non-magnetic cylinder must provide the oxygen supply.

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