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.

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® 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

0123

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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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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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 O		Connector (top faceplate icon).
	O2			2
		(40 - 87 PSIG)

Exhalation Valve (top faceplate icon).

NOT OCC

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	Indicates that an external battery is powering the ventilator.
BATT
	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	Feature OFF -- feature or alarm not selected.
on	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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Abbreviations

A/C- Assist/Control

AEV- Automatic Electrical Ventilator

ACLS- Advanced Cardiac Life Support

ALS- Advanced Life Support

ATLS- Advanced Trauma Life Support

ACV- Assist-Control Ventilation

AMC- Alarm Message Center

APOD- Advanced Probe Off Detection

ATPD - Atmospheric Temperature and Pressure Dry b/min- Beats Per Minute

B/V - Bacterial/Viral Filter

BiPAP- Bilevel positive airway pressure

BPM - Breaths per Minute

cm H2O - Centimeters of Water

CPAP- Continuous Positive Airway Pressure

CPR - Cardiopulmonary Resuscitation

CPU- Central Processor Unit

dBA- Decibel

DISS - Diameter Index Safety System

EMC- Electromagnetic Compatibility

EMV- Emergency Medical Ventilator

ESD- Electrostatic Discharge

FIO2 - Fraction of Inspired Oxygen

HME - Heat and Moisture Exchanger

HMEF - Heat and Moisture Exchanger/Bacterial Viral filter combined

HP O2- High Pressure Oxygen

Hz – Hertz (as in frequency, cycles per second)

I:E- Inverse ratio

ID - Internal Diameter

L - Liters

LCD- Liquid Crystal Display

LED - Light Emitting Diode

LPM - Liters Per Minute ml - Milliliters

mm - Millimeter

MRI- Magnetic Resonance Imaging

NPPV – Noninvasive Positive Pressure Ventilation O2- oxygen

Paw - Airway Pressure

PEEP - Positive End Expiratory Pressure

PIP - Peak Inspiratory Pressure

PPV- Positive-Pressure Ventilation

PS- Pressure support

psig - Pounds per Square Inch Gage

RF- Radio Frequency

RGA #- Returned-Goods-Authorization number

RTC- Real time clock

SIMV- Synchronized Intermittent Mandatory

Ventilation

SPM- Smart Pneumatic Module

USP - United States Pharmacopeia

VAC - Volts AC

VDC - Volts DC

VT - Tidal Volume

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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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 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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•Ensure proper operation of the ventilator’s breathing system.

•12 ft ventilator circuits are available for use with the ventilator -- the additional length enables a suitable separation between the ventilator and the bore opening. (REF 820-130-00 -- Adult/Pediatric Wye Ventilator Circuit; REF 820-131-00 -- Pediatric/Infant Wye Ventilator Circuit).

•The extended tubing length of a 12 ft ventilator circuit can result in loss of volume due to additional compressibility.

--Set the Tubing Compliance (TC) to OFF and ensure that the patient is receiving correct tidal volume.

--Alternatively, calculate the TC as described by the ventilator circuit’s Instructions For Use (IFU) and adjust the TC value to ensure that the patient is receiving the correct tidal volume.

•DO NOT use the 12 ft circuit with settings below 5 cmH20.

•Ensure that the ventilator is able to maintain PEEP -- for patients with short expiratory times, the additional tubing length of the 12 ft circuit may affect system behavior.

Cautions

•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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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: [phone] Telephone: [phone]

Notification of Adverse Events

As a health care provider, you may have responsibilities under the Safe Medical Devices Act (SMDA), for reporting to ZOLL Medical Corporation, and possibly to the FDA, the occurrence of certain events.

These events, described in 21 CFR Part 803, include device-related death and serious injury or illness. In addition, as part of our Quality Assurance Program, ZOLL Medical Corporation requests to be notified of device failures or malfunctions. This information is required to ensure that ZOLL Medical Corporation provides only the highest quality products.

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Software License

Note: Read this Operator’s Guide and License agreement carefully before operating any of the 731 Series Ventilator products.

Software incorporated into the system is protected by copyright laws and international copyright treaties as well as other intellectual property laws and treaties. This software is licensed, not sold. By taking delivery of and using this system, the Purchaser signifies agreement to and acceptance of the following terms and conditions:

1.Grant of License: In consideration of payment of the software license fee which is part of the price paid for this product, ZOLL Medical Corporation grants the Purchaser a nonexclusive license, without right to sublicense, to use the system software in object-code form only.

2.Ownership of Software/Firmware: Title to, ownership of, and all rights and interests in the system software and all copies thereof remain at all times vested in the manufacturer, and Licensors to ZOLL Medical Corporation and they do not pass to purchaser.

3.Assignment: Purchaser agrees not to assign, sublicense, or otherwise transfer or share its rights under the license without the express written permission of ZOLL Medical Corporation.

4.Use Restrictions: As the Purchaser, you may physically transfer the products from one location to another provided that the software/firmware is not copied. You may not disclose, publish, translate, release, or distribute copies of the software/firmware to others. You may not modify, adapt, translate, reverse engineer, decompile, crosscompile, disassemble, or create derivative works based on the software/firmware.

NO IMPLIED LICENSE

Possession or purchase of this device does not convey any express or implied license to use the device with replacement parts which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to this device.

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GENERAL INFORMATION

Limited Warranty

ZOLL warrants the device to be free from all defects in material and workmanship for a period of one (1) year from the date of delivery to the original purchaser.

During the warranty period, ZOLL will repair or replace the device or any part which upon examination is shown to be defective. At its sole discretion, ZOLL may choose to supply a new or equivalent replacement product or refund the amount of the purchase price (on the date sold by ZOLL). To qualify for such repair, replacement, or refund, the defective device must be returned to the ZOLL Service Center within thirty (30) days from the date that the defect is discovered. This warranty does not apply if the device has been repaired or modified without the authorization of ZOLL or if the damage was caused by incorrect (off-label) use, negligence, or an accident.

Batteries, which by their nature are consumable and subjected to environmental extremes, will be warranted only for a period of ninety (90) days. Accessories, also consumable in usage, such as connecting hose and breathing circuits, are not warranted.

DISCLAIMER OF IMPLIED & OTHER WARRANTIES:

THE PRECEDING WARRANTY IS THE EXCLUSIVE WARRANTY AND ZOLL MAKES NO OTHER WARRANTY OR REPRESENTATION OF ANY KIND WHATSOEVER, EXPRESS OR IMPLIED, WITH RESPECT TO MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR ANY OTHER MATTER. THE REMEDIES STATED IN THIS DOCUMENT WILL BE THE EXCLUSIVE REMEDIES AVAILABLE TO THE CUSTOMER FOR ANY DEFECTS OR FOR DAMAGES RESULTING FROM ANY CAUSE WHATSOEVER AND WITHOUT LIMITATION.

ZOLL WILL NOT IN ANY EVENT BE LIABLE TO THE CUSTOMER FOR CONSEQUENTIAL OR INCIDENTAL DAMAGES OF ANY KIND, WHETHER FOR DEFECTIVE OR NONCONFORMING PRODUCTS, BREACH OR REPUDIATION OF ANY TERM OR CONDITION OF THIS DOCUMENT, NEGIGENCE, OR ANY OTHER REASON.

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Service

If a unit requires service, contact the ZOLL Technical Service Department.

For customers In the U.S.A.		For customers outside the U.S.A.
Telephone:	1-973-882-1212	Call the nearest authorized ZOLL Medical Corporation
		representative.
Fax:	1-978-421-0010	To locate an authorized service center, contact the
		International Sales Department at
		ZOLL Medical Corporation
		269 Mill Road
		Chelmsford, MA 01824
		Telephone: [phone]

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 available) or equivalent packaging. Be sure the assigned service request number appears on each package.

For customers	Return the unit to
In the U.S.A.	ZOLL Medical Corporation
	269 Mill Road
	Elmsford, MA 01824
	Attention: Technical Service Department (SR number)
	Telephone: [phone]
In Canada	ZOLL Medical Canada Inc.
	1750 Sismet Road, Unit #1
	Mississauga, ON L4W 1R6
	Attention: Technical Service Department (SR number)
	Telephone: [phone]

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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: [phone]

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Chapter 2

Product Overview

This chapter provides an overview of the ZOLL Ventilator, which you can use to manage infant through adult patients with acute or chronic respiratory failure or patients that you are resuscitating by providing continuous positive-pressure ventilation. (See Indications for Use in Chapter 1.)

This chapter describes the ZOLL Ventilator models, providing a list of common features and attributes, as well as descriptions of each model. This chapter also provides more detailed descriptions of the following ventilator features:

•Controls and Indicators

•Display Screen

•Pneumatic Design

•Fresh Gas Intake

•Connector Panel

•Ventilator Circuits

•Pulse Oximeter

•Power Sources

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PRODUCT OVERVIEW

ZOLL Ventilator Models

The ZOLL Ventilator is available as the AEV, EMV+, and Eagle II models. The ventilator offers a range of ventilatory modes to support EMS, military, air transport, and hospital transport needs.

The AEV ventilator is designed for managing ventilator support patients during ambulance transport. Its ventilation modes (AC, CPAP with PS, and BL) are specifically chosen to be consistent with pre-hospital care provider's operating procedures.

The EMV+ ventilator's rugged design makes it ideal for use in emergency vehicle and air transport of patients. It has a wide range of ventilation modes, such as AC, SIMV, CPAP, and BL.

The Eagle II ventilator adapts the design of for the EMV+ for use by emergency departments and intra-hospital transport. Its design also allows it to be mounted onto walls or onto specified boom arms and roll stands as well as gurneys.

The ZOLL ventilators have been approved for use in MRI suites. The EMV+ and Eagle II ventilators have MRI-compatible variants available. The MRI-compatible ventilators can operate in 3.0 Tesla environments and can be placed approximately 6 1/2 ft. from the bore opening for easy and safe access to the patient. See Chapter 3 for more information regarding safe operation in the MRI Environment.

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ZOLL Ventilator Features

The ZOLL Ventilator models have these common features:

•Rugged design

•Weight: ~10 lbs

•10 hour battery life

•Rapid charger to achieve 90% battery capacity in 2 hours

•High performance internal compressor

•Smart Help messages

•Integral SpO2 (Masimo)

•Airworthiness Release

•Daylight visible display

•Oxygen efficient

•Supports infant, pediatric, and adult patients

•Limited 1 year warranty

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PRODUCT OVERVIEW

ZOLL Ventilator Device Description

The following illustration shows the ZOLL Ventilator’s main features:

1 3 4 5

2		10

6

7		11

8

9

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