ZOLL EMV+, AEV, Eagle II User manual

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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”.

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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

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

280 - 600 kPa (40 - 87 PSIG)

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).

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.

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.

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GENERAL INFORMATION

EXT

BATT

off

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).

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

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

- Airway Pressure

Ventilation

VDC - Volts DC

HP O

- High Pressure Oxygen VT -

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

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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

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 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

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

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.

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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 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

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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 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)

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PRODUCT OVERVIEW

345

ZOLL Ventilator Device Description

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

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Item Description

Top

1. Oxygen Inlet Connects the unit to an external oxygen source

2. Status Indicator LED Array Lights up to indicate status of the unit, connected to alarms

3. External Power Input Connector Connects the unit to an external power source

4. USB Connector Connects the unit to a USB drive or USB compatible device

5. Pulse Oximeter Connector Connects the unit to a Pulse Oximeter sensor

Front

6. LCD Display Displays the unit’s settings, patient data, and alarm information

7. Alarm Message Center Displays active alarms and mitigation information

8. Control Panel Access to the unit settings

Bottom

9. Battery Compartment Contains the unit’s rechargeable lithium ion battery

Side

10. Fresh Gas/Emergency Air Intake Allows the unit’s internal compressor to take ambient air and acts as an anti-asphyxia valve

11. Handle

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PRODUCT OVERVIEW

Controls and Indicators

The ZOLL Ventilator has controls and indicators that facilitate ease of use and visibility in all operating environments.

This ventilator’s control panel includes a display screen (liquid crystal display -- LCD), an LED array, and the controls that you use to set up and manage the ventilator.

The ventilator’s controls consist of the following:

1. Power On/Off Switch -- turns the ventilator on and off.

2. Parameter buttons -- chooses parameter values.

3. Menu Button -- displays the main menu.

4. Selection dial -- changes the value of the highlighted parameter value.

5. Mute/Cancel button -- mutes audible alarm indicators and cancels parameter entries.

6. Accept/Select button -- accepts parameter value entries, Pop Up conditions or menu

selections.

7. Manual Breath/P Plat (Plateau Pressure) button -- issues a manual breath, and for the

EMV+ and Eagle II models, provides the ability to conduct a plateau pressure maneuver.

The ventilator’s indicators consist of the following:

8. LCD Display -- Brightness and backlight controls are available in the main menu (we

describe the display in more detail later in this chapter).

9. LED Array -- Indicates status of the v entila tor’s operation by lighting red, yellow, or green

LED’s.

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Display Screen

Message Area

Shared Icon Area

Auxiliary Parameter Boxes

Parameter Windows

The ZOLL Ventilator’s display screen has four functional areas:

Message Area

The display screen’s message area can display the following:

• Airway Pressure and Pleth Waveform Plots -- Under normal operation (as in the example

• Menus -- Displays the Main Menu after you press the menu button on the ventilator’s

• Alarms -- When an alarms occur, the message area displays Smart Help messages that

• Popup Windows -- Display information that assists you when adjusting parameter values.

Parameter Windows

Parameter windows display the measurements, alarm limits, and associated parameters fo r their labeled parameters. Parameter values that you can adjust, such as alarm limits, appear as solid text. Parameter values that you cannot adjust, such as measurements taken by the ventilator, appear as outlined text. We provide information on adjusting parameter values in Chapter 4, “Using the ZOLL Ventilator.”

above), the message area displays plots for airway pressure and, when the pulse oximeter is connected, the Pleth waveform.

control panel, or displays a parameter’s context menu (which appears after you press and hold the associated parameter button on the control panel). When a plot is necessary to facilitate a parameter adjustment, the message area displays both the plot and the parameter’s context menu.

identify the alarms and describe possible causes and actions that you can take in response.

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PRODUCT OVERVIEW

Shared Icon Area

Directly below the message area, the unit displays icons that indicate

• Power source (external power or internal battery)

• Battery Charge Status

• Oxygen Supply attached

• Alarm Muted/Audible

Auxiliary Parameter Boxes

Some parameters have values that the ventilator displays in the parameter boxes at the bottom of the display screen. You can adjust these values using the parameter’s context menu.

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Pneumatic Design

The ZOLL Ventilator includes an oxygen valve and a compressor to provide the gas to the output port. The system includes transd ucers for pressure mea surements includin g input supp ly pressure and barometric readings.

The wye circuit is part of the ventilator’s pneumatic system. The inspiratory side of the wye circuit provides gas to the patient. The expiratory side exhausts directly to atmosphere without returning to the ventilator. The ventilator pneumatically controls the exhalation valve and a transducer within the ventilator measures the airway pressure.

The following image is a diagram of the ventilator’s pneumatic design.

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PRODUCT OVERVIEW

External Power Input

Gas Output

High Pressure Oxygen Input

Transducer (Patient Airway Pressure)

Exhalation Valve

Fresh Gas/ Emergency Air Intake

Pulse Oximeter Connector

+ USB Connector

Fresh Gas Intake and Attachments

The fresh gas intake, which is located on the side of the ventilator, allows ambient air into the unit’s internal compressor. The intake also acts as an anti-asphyxia value that enables the patient to breath ambient air should the ventilator fail.

The fresh gas intake contains a particulate filter and permits the operator to connect either a bacteria/viral or a chemical/biological filter depending on ambient conditions

ZOLL provides an O2 Reservoir Kit to allow for low flow oxygen supply to the ventilator. An oxygen concentrator source provides oxygen to the O2 reservoir.

Top Panel

The ZOLL Ventilator’s top panel appears as follows:

The oxygen hose, ventilator circuit, external power, and pulse oximeter attach to the top panel of the ventilator. The USB port is only used when servicing the unit.

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Oxygen Input: High Pressure Gas Supply

The external high pressure gas source connects to the device using the high pressure oxygen input port.

The device attaches to a regulated supply of 40 to 87 PSIG (280 to 600 kPa). The maximum flow rate of the oxygen supply is 100 liters per minute. This supply can be fro m a medical grade oxygen system or oxygen cylinder (USP).

The OXYGEN IN fitting has a male oxygen Diameter Index Safety System (D.I.S.S.) thread. Note: If external oxygen is connected, the gas pressure must be at least 41-psig (± 2 psig) when

the device performs Self-Check after you power on the unit.

High Pressure Oxygen Supply Hose

A standard 6 foot oxygen hose is available to make the connection to the high pressure oxygen source. The hose is has compatible fittings between the device an the source identified for use. (Also see Chapter 6 “Operating Environments” ). Hose s are avail abl e from ZOLL, or a suitable alternative as described below can be used as indicated in the table below.

High Pressure Hoses need to comply with ISO standards

Device Side

Connections

DISS 6 ft (maximum 20ft)

Green or White (as determined by local regulations)

Non-conductive

Hose Attributes Supply Side Connections

Quick Disconnect, DISS, etc.

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PRODUCT OVERVIEW

Figure 2-1 Ventilator Gas Sources

Ventilator Circuits

The ZOLL Ventilator operates using a standard disposable ventilator circuit. The Ventilator circuit attaches to the device using three ports on the top of the device.

• Gas Output -- connects to the ventilator circuit using 22 mm ID corrugated hose. The

connector is a 22 mm male conical connection.

• Transducer (Patient Airway Pr essure) -- connects to the ventilator circuit using a

3/16 inch ID transducer tubing. The barb-type connector is colored a green/blue to distinguish it from the other connector s .

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• Exhalation Valve -- connects to the ventilator circuit using 1/4 inch ID exhalation valve

tubing. The barb-type con ne cto r is clear anodized aluminum to distinguish it from the oth er connectors (the 1/4 inch ID ventilator circuit exhalation valve tubing is clear).

Ventilator Circuit Connections

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PRODUCT OVERVIEW

Ventilator Circuit Types

The ZOLL Ventilator can use 6 ft or 12 ft ventilator circuits to support adult, pediatric, and infant patients.

Ventilator Circuits

ZOLL provides the following circuit types:

• Pediatric/Adult, 6 ft (REF 820-0106-XX)

Infant/Pediatric, 6 ft (REF 820-0107-XX)

•

Pediatric/Adult, 12 ft (REF 820-0130-XX) Infant/Pediatric, 12 ft (REF 820-0131-XX)

•

Caution Always dispose of the circuit after single patient use following the institutional guidelines for

biologically contaminated material. Reusing the circuit can result in cross contamination between patients.

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Pulse Oximeter Sensors

The Masimo Pulse Oximeter is an optional function of the ZOLL Ventilator. When the appropriate sensor is connected, the pulse oximeter provides continuous noninvasive monitoring of arterial hemoglobin (SpO

adult, pediatric and infant patients. The Masimo LCSN series of probes are approved for use with the ventilator. The Accessory

table in Appendix A lists the sensors which are available for use with the ZOLL Ventilator.

Power Sources

The ZOLL Ventilator can operate using external power or it can operate powered by its internal Lithium Ion Battery.

The external AC/DC Power Supply that ZOLL provides with the ventilator delivers a DC input to the device of 24V at 4.2A. When this external power source is present, the ventilator automatically charges its internal battery while operating.

The external AC/DC Power Supply is a universal supply that can operate with an input of 100-240 VAC 50/60 Hz. The external supply can also power the device when provided with a 400 Hz input.

You should only use the extern al power supp ly provided with th e ventilator when connecting to AC power. This power supply provides both Class I and Class II protection.

) and pulse rate (measured by the SpO2 sensor) for

Operating Using External DC Power

The ZOLL Ventilator can also operate using external DC power. When conne cted to a sta ndard vehicle DC outlet using either the 12 or 28 VDC Power Cable that ZOLL provides, the ventilator automatically charges its internal battery while operating.

Note: The input connector of the ventilator accepts DC voltages between 11.8 to 30.0 VDC.

Caution When using the standard vehicle DC outlet, do not jump start the vehicle during op eration of the

ventilator.

Operating Using Battery Power

When an external power failure occurs, the ventilator automatically switches to its internal battery for operating power and activates the EXTERNA L POWER FAILURE alarm; there is no interruption in operation or loss of any alarms. When external power returns, operating power automatically switches to the external power sourc e.

In the event that the ventilator needs to be shutdown, turn the POWER switch to the OFF ("O") position. If this fails to work or puts the patient or operator at possible risk, disconnect the device from the external power source.

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PRODUCT OVERVIEW

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Chapter 3

Setting Up the ZOLL Ventilator

This chapter describes how to set up the ZOLL Ventilator. It lists the tasks required to set up the ventilator for safe, effective use, and describes each task in detail.

Warning ! You must always p r o perly set up the ventila tor before use. Failure to do so can result in

inadequate care or death of the patient.

To set up the ZOLL Ventilator, you must perform the following tasks:

1. Attach the Ventilator Circu it

2. Attach the High Pressure Oxygen Supply (Optional)

3. Inspect Fresh Gas Intake Filters

4. Connect Fresh Gas Intake Attachments

5. Select the Ventilator’s Power Source

6. Power on the Ventilator

7. Select Start Up Default Values

8. Select Operating Mode (Optional)

9. Change Parameter Values

10.Change Ventilator Settings

11. Perform Operational Test

12.Attach the Pulse Oximeter Probe (Optional)

13.Attach Patient

We describe how to perform these tasks in the following sections of this chapter.

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SETTING UP THE ZOLL VENTILATOR

Warning! Always follow standard of care, which includes preparations to bag the patient.

DO NOT start up the ventilator with the patient attached.

1. Attach the Ventilator Circuit

Select the correct ventilator circuit for the patient and environment (as we describe in the previous chapter). Always follow the instructions included with the circuit.

Attach the ventilator circuit to the ventilator’s top panel. Connect

• The 22 mm corrugated hose to the ventilator’s gas output

• The green/blue 3/16 inch ID airway pressure line to the pressure transducer

• The clear 1/4 inch ID exhalation valve control line to the exhalation valve fitting.

Ventilator Circuit Device Connections

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2. Attach the High Pressure Oxygen Supply (Optional)

Oxygen Inlet

Fresh Gas Intake

Since the ventilator includes an internal compressor, the attachment of a high pressure oxygen supply is optional.

Review the high pressure supply requirements that we describe in Chapter 2, and use the oxygen hose to attach the ventilator’s oxygen inlet to the high pressure gas source.

Note: Use only with medical-grade (USP) oxygen. When using with an oxygen cylinder, the

cylinder must be secured.

Note: The O

Hose is either colored green or white, depending on co untry specifications.

3. Inspect Fresh Gas Intake Filters

The fresh gas intake is the gas source for the ventilator’s internal compressor. The ventilator normally operates with two built-in filters:

1. Removable Foam Filter (

2. Fresh Gas Intake Disk Filter (REF 465-0027-00)

Inspect the filters and, if dirty, replace them (See Chapter 7, “Replacing the Ventilator’s Filters”).

REF 465-0028-00)

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SETTING UP THE ZOLL VENTILATOR

4. Connect Fresh Gas Intake Attachments

The operating environment of the ventilator may require you to connect the following attachments to the Fresh Gas Intake:

Oxygen Reservoir Bag

If the ventilator will use oxygen from low-flow sources, you may choose to attach an Oxygen Reservoir Bag Assembly (

Bacterial/Viral (BV) Filter

If the ventilator will operate in an environment where the patient is at risk from cross contamination or airborne pathogens, you may choose to attach a BV filter (See Chapter 6, “Using the ZOLL Ventilator in Hazard ous Environments”).

Chemical/Biological C2A1 Filter

If the ventilator will operate in a contaminated environment, you may choose to attach a chemical/biological C2A1 filter (See Chapter 6, “Using the ZOLL Ventilator in Hazardous Environments”).

REF 704-0004-00).

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5. Select the Ventilator’s Power Source

The ZOLL Ventilator can run using one of the following power sources:

1. Internal 14.4V lithium ion (Li Ion) rechargeable battery with 6.75 Ah capacity (fully charged, the battery provides 10 hours of operation at factory default settings with pulse oximeter operating at 25C).

2. External AC/DC Power Supply that ZOLL provides (100-240 VAC 50/60 and 400 Hz with

an IEC 320 style AC input connector. The AC/DC Power Supply provides a DC output of 24V at 4.2A.

3. External DC power from a standard vehicle DC outlet using either the 12 or 28 VDC Power

Cable that ZOLL provides to connect the ventilat or to the DC ou tlet. The ZOLL Ventilator’s input connector accepts DC voltages between 11.8 to 30.0 VDC.

4. An external battery.

The ZOLL Ventilator uses external power when available rather than its internal battery pack. When an acceptable external power source is present, the ventilator automatically charges the internal battery while the unit operates. When an external power failure occurs, the unit automatically switches to its internal ba tte ry for operati ng power and activate s the EXTERNAL POWER FAILURE alarm; there is no interruption in operation or loss of any alarms. When external power returns, operating power automatically switches from internal power to the external source.

In the event that the device needs to be shutdown, turn the POWER switch to the OFF (“O”) position. If this fails to work or puts the patient or operator at possible risk, disconnect the device from the mains power.

T o connect t he ventilator to an external power source, c onnect an AC/DC Power Supply plug to the unit’s External Power Input and an acceptable electrical outlet.

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SETTING UP THE ZOLL VENTILATOR

Connecting the Power Supply

Connect the external power cable to the ventilator as follows:

Connecting and Disconnecting the Power Supply

Caution Do not twist the power cable connection plug. Pinch the plug and slide up to release the safety

latches. Failure to do so may damage the power co nnection plug and prevent it fro m functioning.

Warning ! If the power supply, power cable, or power connection plugs are damaged or become

damaged during use, immediately disconnect the power cable from external power and the power supply assembly.

Power Supply Latching

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6. Power On the Ventilator

To power on the ventilator, turn the POWER switch to “1”.

After powering on, the unit performs its Self Check procedure, which checks for preexisting alarm conditions and the operation of the pneumatic system, internal communications, and power system. After completing the Self Check, the ventilator begins to operate immediately, and monitors the presence of alarms continuously.

Power Switch

During start-up, the ventilator’s alarms are disabled for 120 seconds to allow you to properly adjust the patient circuit, pulse oxim eter, and ventilator settings without distraction.

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SETTING UP THE ZOLL VENTILATOR

7. Select Start Up Default Values

When you power on the ventilator, the Start Menu appears, through which you choose the appropriate parameter default values for the patient. You can select the following patient parameter defaults:

• Adult

• Pediatric

• Mask CPAP -- Continuous Positive Airway Pressure (CPAP)

• Custom -- Values saved in a previous session

• Last Settings -- Values set for the patient last using the device before powering down

Note: The ventilator can may be configured to automatically select the Adult parameter

defaults at start up.

Adult Default Parameter Values

The Adult default parameter values are as follows:

Adult Parameter Default Values

Mode AC (V) BPM 12 I:E 1:3 VT 450 PEEP 5 PIP Limit 35 FIO2 21

Pediatric Default Parameter Values

The Pediatric default parameter values are as follows:

Pediatric Parameter Start-Up Defaults

Mode SIMV (P) BPM 20 Ti 0:6 PIP 20 PEEP 4 PIP Limit 30 FIO2 21

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Mask CPAP Default Parameter Values

The Mask CPAP default parameter values are as follows:

Mask CPAP Parameter Start-Up Defaults

Mode CPAP

Backup BPM 12 Backup I:E 1:3.0 Backup PIP 20 PEEP 4 PIP Limit 30 FIO2 21

To select the unit’s default parameter values, highlight one of the above settings in the Start Menu and press the ACCEPT/SELECT button. To operate with parameter values that dif fer from the default values, use the unit’s Parameter buttons (see the “Changing Parameter Values” section later in this chapter).

Note: You can configure the ventilator to automatically select Adult parameter defaults at

start up.

To adjust the parameter settings, always work from the lowest parameter button, Mode, to the highest button, HR. The values that you select in a lower parameter window may affect the values that appear in higher parameter windows

Warning! Never use the Noninvasive Positive Pressure Ventilation (NPPV) modes on a patient

that is NOT spontaneously breathing and/or may stop spontaneously breathing. CPAP and BL are intended for ventilatory support, NOT ventilation.

When an NPPV mode is in operation, the head with mask icon appears in the location used by the speaker/mute icons. Low and Medium priority alarms cause this head with mask ico n to disappear.

It reappears when Low priority alarms are muted. When Medium priority alarms are muted, the muted speaker icon appears.

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SETTING UP THE ZOLL VENTILATOR

8. Select Operating Mode (Optional)

The ventilator offers four operating modes that you can select to optimally manage the patient (each mode can use either pressure or volume targeting):

1. AC (Assist/Control) -- The patient receives either controlled or assisted breaths. When the patient triggers an assisted breath, they receive a breath based on either the volume or pressure target.

2. SIMV (Synchronized Intermittent Mandatory Ventilation)-- The patient receives controlled

breaths based on the set breathing rate. Spontaneous breat hs are eith er unsup ported de mand flow or supported using Pressure Support. (This mode is not available in the AEV

3. CPAP (Continuous Positive Airway Pressure) -- The patient receives constant positive

airway pressure while breathing spontaneously . Sp ontaneous breaths are either demand flow or supported using Pressure Support.

4. BL (bilevel) -- the ventilator prov ides two pressure settings to assist patients breathing

spontaneously: a higher inhalation pressure (IPAP) and a lower exhalation pressure (EPAP).

To select the operating mode, press the Mode parameter button, turn the selection dial to highlight the mode you want to use, and press the Accept/Select button.

When transitioning from active ventilation to NPPV modes, or from NPPV Modes to active ventilation modes, the following parameter/alarm limit may be adjusted:

unit.)

Alarm/Parameter

Low BPM Alarm

High BPM Alarm

Low Airway Pressure Alarm

PEEP

High Limit

Low Limit

Rise Time

Pressure Support

Warning! The transition into NPPV automatically sets the rise time to 3, which may be too fast for

infants and small children. Befor e using the ventilator with an infant or small child, you should always configure the ventilator appropriately before attaching the patient.

Note: An alarm triggers when you connect the patient to the ventilator while the Start Menu

is still active. To resolve the alarm, you must select a mo de of ventilation and configure the device appropriately for the patient. In addition, you should perform the Operational Test procedure before reconnecting the patient to the device.

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9. Change Parameter Values

If the patient requires parameter values that differ from the default values, you can use the parameter buttons to change these values, as necessary. To change the parameter values, press the Parameter buttons to display the primary parameter and secondary parameter values, or Press and hold the parameter button to display the pa rameter’ s contex t menu. Use th e selection dial to adjust the highlighted parameter. Press the Accept/Select button to implement the change.

10. Change Ventilator Settings

The Menu button displays the Main Menu, which allows you to change various Ventilator settings, such as the contrast or brightness of the unit’s Display Screen (LCD Contrast/LCD Brightness).

When you press the Menu button, the Main Menu appears:

• Alarm Config

• Powerup Settings

• LCD Contrast

• LCD Brightness

• GMT Offset

• Unit Info

• Alarm History

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SETTING UP THE ZOLL VENTILATOR

11. Perform Operational Test

Before attaching the patient to the ventilator, you must perform an Operational Test to ensure that the breathing circui t is prop erly atta ched an d that the primary pat ient safety alarms, such as PATIENT DISCONNECT and AIRWAY PRESSURE HIGH are functioning properly.

Operational Test Procedure Press the MANUAL BREATH button; gas should flow out of the patient connection each time

the button is pressed. The minimum period between manual breaths is limited by the tidal volume and the time

required to complete a full exhalation based on the I:E ratio.) Close the patient port with a gloved hand. During inspiratory phase, th e HIGH AIRWAY

PRESSURE LIMIT alarm should activate after 2 breaths that reach the PIP High Limit. If the AIRWAY PRESSURE HIGH alarm fails to activate, ensure that all of the tubing

connections are secure, the exhalation valve is closing during inhalation, and that the High Airway Pressure Limit is set to 35 cm H2O or less.

After a breath or two, release the patient port while allowing the ventilator to operate. The PATIENT DISCONNECT alarm should activate.

Partially close the patient port to reset the PATIENT DISCONNECT alarm. With no other alarms occurring, remove external power from the ventilator. The EXTERNAL POWER

LOW/DISCONNECT alarms should activate. Reconnect external power to reset alarms. If either the HIGH AIR WAY PRESSURE, PATIENT DISCONNECT, or EXTERNAL POWER

LOW/DISCONNECT alarms fail to activate, continue to manually ventilate the patient, replace the ventilator, and send the unit in for service.

If operating using the internal battery, verify that the Battery icon indicates sufficient available battery capacity remains to support the anticipated duration of operation. If not, begin ventilation and find an alternate source of power.

The trigger automatically adjusts when the PEEP is changed. Until you have determined that the ventilator is functioning properly and that the ventilator

parameters are set correctly for the patient, do not connect the patient to the ventilator.

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12. Attach the Pulse Oximeter Probe (Optional)

The pulse oximeter becomes operational in all ventilator modes when its cable and sensor are properly attached to the SpO

SpO2 and HR Parameter Windows display stby).

connector (during start up, the p ulse oximeter is o n standby -- the

T o operate the pulse oximet er, connect the sensor probe to the patient and the cable to the SpO connector on the top of the ventilator as shown in the following illustration:

Connecting the Pulse Oximeter Sensor

The monitoring function begins automatically when a valid patient signal is detected for > 10 seconds.

For more information about the Masimo pulse oximetry technology that the ZOLL Ventilator uses, see Appendix C, Pulse Oximeter Principles.

13. Attach Patient

After you confirm that the ventilator is operating correctly, detach the test lung (if used in the Operational Test) from the ventilator circuit.

Attach the patient to the ventilator using the appropriate connector (tracheal tube or laryngeal mask) to the ventilator circuit.

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SETTING UP THE ZOLL VENTILATOR

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Chapter 4

Using the ZOLL Ventilator

This chapter describes how to use the ZOLL Ventilator. Effective operation of the ventilator requires understanding of the following information:

• The ZOLL Ventilator Interface and Parameter Windows

• Changing Parameter Values

• Selecting Venti lation Mode Options

• Using the Pulse Oximeter

• Managing Pop Up Messages

• Managing Alarms

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USING THE ZOLL VENTILATOR

The Ventilator Interface

The ZOLL Ventilator uses a Graphical Use Interface (GUI) to display the parameter settings and patient readings.

Changing Parameter Values

The ZOLL Ventilator helps you to manage the patient by organizing ventilatory parameters in parameter windows on the right side of the display screen. These parameter windows display the primary and secondary parameters and the alarm settin gs for that parameter. In addition, set values and measurements appear in the auxiliary boxes at the bottom of the display scre en .

Additional settings used to manage t he patient are applied usi ng the context menu fo r parameter group.

The sections below describe the parameter windows and the associated context menus for each parameter. A table addresses availability of the parameter and its use in the device models.

The parameter window values are chosen with the parameter button:

Single Press: chooses primary parameter Multiple Presses: chooses the secondary parameter and alarm limits Press and Hold: chooses the context menu

T o prevent setting of para meter val ues th at are outside th e typica l clinic al rang e of setting s, the ZOLL Ventilator displays Pop Up messages that ask if you are sure you would like to set the parameter beyond the typical range. We describe Pop Up messages in more detail in Chapter 5.

Parameter Buttons

The parameter windows, from lowest to highest, are

• Mode

• BPM (Breaths per Minute)

• Vt (Tidal Volume -- V

• PIP (Peak Inspiratory Pressure)

• FIO2

• SpO2

• HR (Heart Rate)

Mode

The ZOLL Ventilator allows you to select different ventilation modes that you can select to optimally manage the patient:

• AC (Assist/Control) -- The patient receives either controlled or assisted breaths. When the

patient triggers an assisted breath, they receive a breath based on either the volume or pressure target.

• SIMV (Synchronized Intermittent Mandatory Ventilation) -- The patient receives

controlled breaths based on the set breathing rate. Spontaneous breaths are either unsupported demand flow or supported using Pressure Support.

)

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• CPAP (Continuous Positive Airway Pressure) -- The patient receives constant positive

airway pressure while breathing spontaneously. Spontane ous breaths are either demand flow or supported using Pressure Support.

• BL (B i Leve l) -- the ventilator provides two pressure settings to assist patients breathing

spontaneously: a higher inhalation pressure (IPAP) and a lower exhalation pressure (EPAP).

Press the Mode parameter button to highlight the current ventilation mode. Press the Mode parameter button again to select volume or pressure targeting which is shown as either “(V)” for volume or “(P)” for pressure.

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USING THE ZOLL VENTILATOR

Breath Target

The selected ventilation mode, and the selection of breath target (volume or pressure) predetermines the parameter availability for the BPM, Vt, and PIP parameter windows.

Volume targeting assures a constant volume is delivered to the patient in the inspiratory time using a constant flow.

Pressure targeting provides a constant airway pressure for the duration of the inspiratory time

Leak Compensation

Leak Compensation provides flow during the expiratory phase to maintain the baseline pressure in patients that are breathing spontaneously, but have a leaking airway or facemask

To avoid nuisance alarms in patients with active leaks, Leak Compensation suppresses he following alarms:

• Incomplete Exhalation (Alarm #3091)

• Insufficient Flow (Alarm #2095)

The following table lists the ventilator modes and their availability in the ZOLL ventilator models, and gives the options and ranges for the ventilation mode parameters:

Parameter Window Options /

Availability/Notes Models

Range

Primary Value Mode AC All

SIMV EMV+, Eagle II CPAP All BL All

Secondary

Target (V) or (P) AC and SIMV modes All parameter Values

(SIMV not available with AEV)

LC On or OFF

Default off

AC(P), SIMV(P) modes EMV+, Eagle II BL modes All

CPAP

Default on

Alarms N/A

Measured Value N/A

Apnea Back Up Context Menu CPAP and BL modes

Apnea Back Up BPM 1 to 80 All

Apnea Back Up PIP 10 to 80 All

Apnea Back Up I:E , Ti 1:1 to

Control selected in con-

All

text BPM Context Menu

1:99, 0.1 to 3

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BPM (Breathes Per Minute) -- Timing and Rate Management

The BPM parameter describes the number of breaths-per -minute . The selected ventilation mode determines when this value is a setting or a measurement.

Assisted and controlled breaths are time-cycled. For spontaneous breaths, the ventilator uses the percent of the peak flow to terminate the breath being delivered (flow cycled).

Control Parameter

The Ti (Inspiratory Time) parameter adjustment sets the inspiratory time for the control and assisted breaths (AC and SIMV modes). For volume targeted breaths, the Ti parameter affects the gas flow rate (the device displays Pop-U p messages when the mini mum and maximum flow rate values have been reached).

Rise Time

When PS is selected, you can adjust the time it takes to reach PIP. You can specify an index of 1 (shortest) to 10 (longest). The device uses the PIP waveform as a reference when selecting the Rise Time for the patient.

You should reassess and readjust the Rise Time settings after the patient is placed on the ventilator and initially stabilized. To minimize patient's work of breathing and potential for pressure overshoots, you must take the following into consideration when setting the Rise Time:

• Patient's respiratory pattern

• Patient's comfort

• Patient's flow demand

• Resistance (Mechanical/Physiological)

• Compliance characteristics

The Rise Time for a passive lung is driven primarily by airway resistance, and is fairly independent of compliance.

Resistance Rise Time

20 3

50 5

200 10

An adult patient with high Resistance may benefit from a Rise Time setting of 3 to 4 for optimal breath delivery. Rise Times of 8 to 10 are optimized for infants and are flow limited. (The infant circuit is not intended for flows > 60 LPM.)

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USING THE ZOLL VENTILATOR

Cycle Off % Parameter

The ZOLL Ventilator transitions from inspiratory to expiratory phase when the flow drops below a set percentage of the peak flow.

You can adjust the Cycle % value t account for patient leaks. Note: The longest duration of a spontaneous breath is 5 seconds. At the end of this time, the

ventilator ends flow and opens the exhalation valve.

Clinicians must carefully assess the patient's response when applying the adjusted % -- you must adjust the % value carefully to optimize patient ventilatory support and comfort.

The Cycle Off % parameter is principally for noninvasive modes where a much higher setting is required to cycle the breath properly in the presence of a leak. If a higher value is not used and there is a leak, the system tends to time cycle at 5 seconds instead of flow cycle (if t he leak flow is higher than 25% of the peak flow, the cycle threshold is never crossed.)

If there is no leak, increasing the Cycle Off % parameter causes breaths to cycle sooner, and deliver less volume. If you set the Cycle Off % parameter too high, the breath ends early relative to patient effort, which may lead to the triggering of a second breath.

Spont Ti Limit Parameter

The Spont Ti Limit parameter provides an additional method to operate the delivery of breaths and maximize patient comfort.

Manual Breath/Plateau Pressure Button

The Manual Breath/Plateau Pressure button delivers a breath only if pressed during the expiratory phase when the airway pressure drops to the PEEP target.

In AC and SIMV, pressing the Manual Breath/Plateau Pressure button deliv ers a breath defined by the settings.

In CPAP and BL, pressing the Manual Breath/Pl ateau Pressure button delivers a breath defined by Apnea Back-Up settings.

Press and hold the Manual Breath/Plateau Pressure button to perform a plateau pressure maneuver.

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BPM Parameter Settings

The following table gives the options and ranges for the BPM parameters:

Parameter Window Options /

Range

Primary Value BPM

Breaths per

minute Secondary

parameter Values

Alarm Limits High breath rate 20 to 99, off

Measured Value Minute Volume

BPM Context Menu

Ti (sec)

|or

I:E

Low breath rate 2 to 40

Vmin (ml)

0 to 80 Volume Target: Control Setting

Ti 0.1 to 3.0 or 1:1 to 1:99

Ti 0.1 to 5.0 or I:E 4:1 to 1:99

0 to 99.9

Availability/Notes Models

All

Pressure Target: Measured

See BPM context menu: Control Parameter

Inverse I:E EMV+,

All

Eagle II

Control Parameter

Rise Time - Default # 1 to 10 Auxiliary Box All

Cycle Off %

(% Cycle ) Spont Ti Limit Default

Default I:E 1:1 to

1:99, 0.3 to 3

Ti 0.1 to 5.0 or

I:E $:1 to !:99

Default 25% 10 to 70% Auxiliary Box All

0.30 to 4.00 Adult = 3.00 Infant = 2.00 Mask CPAP =

3.00

The control value is shown in the Parameter window, the dependent value is shown in the Auxiliary Box.

Inverse I:E EMV+,

All

Eagle II

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USING THE ZOLL VENTILATOR

Vt (Tidal Volume)

The Vt parameter gives the tidal volume (ml) delivered to the lung. The selected ventilation mode determines if this value is a setting or a measurement.

In volume targeted modes, pressing the VT parameter button highlights the current set tidal volume and enables it to be changed.

In pressure targeted breaths, the delivered tidal volume is shown as outlined text and is based on the patient pulmonary mechanics. The VT High and Low Limits are also available as secondary parameters.

Warning! In NPPV, a VT that is lower than anticipated given the patient's size may be an

indication that the patient is not able to adequately spontaneously ventilate.

The ventilator circuit is part of the breathing system of the ventila tor. Tubing compliance of the circuit is a physical property that affects the tidal volume delivered to the patient. The ZOLL Ventilator allows you to adjust the compliance value of the circuit (see Chapter 6 for more information).

Note: In the CPAP-NPPV, the V

volume going to the patient when leaks are present. The O display the O

use, though the amount used is more than if no leak was present.

delivered and V

may be overestimates of the true

min

Use values accurately

Warning! If significant leaks are present during NPPV modes, the VT delivered and V

may be overestimates of what is actua lly being deli vered to the pati ent. The adequacy of ventilation should be assessed using an alternate method.

min

shown

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The following table gives the options and ranges for the Vt parameters:

Parameter Window Options /

Range

Primary Value Vt

Secondary

Alarm Limits High Vt 50 to 2000,

Low Vt 5 to 500,

Vt Context Menu

Tubing Compliance (CT)

Adult Default: 1.60 0 to 3.50 The changed value is not

Infant Default: 0.50 0 to 2.00 All

Compliance Volume (ml)

Default : Off OFF, Adult,

(Measured value )

50 to 2000 Volume Target: Control Setting

Off

Infant

0 to 349 All

Availability/Notes Models

All

Pressure Target: Measured

Auxiliary Box All

All retained when the device is turned OFF

PIP (Peak Inspiratory Pressure) -- Pressure Management

In volume targeted modes, the primary field shows the delivered PIP as outline text. In pressure targeted modes, the PIP target is displayed and is adjustable. The PIP High Limit, PIP Low Limit, and PEEP are also available as second ary parame ters.

During the exhalation phase, the ventilator opens the exhalation valve when the pressure is above the PEEP setting, and closes it when below the setting.

In Bilevel Ventilation Mode, the ventilator provides noninvasive ventilation with the ability to manage the patient by adjusting the IPAP and EPAP parameters.

Caution Set the trigger level to minimize the work of breathing for the patient and prevent

auto-triggering. Set the Vt alarms to bracket average tidal volume so that the unit detec ts pending respiratory failure (low tidal volumes) and excessive leaks (h ig h tid al vo lumes).

Spontaneous/Assisted Breath Trigger

The Spontaneous/Assisted Breath Trigger is preset to -2.0 cm H2O and can be adjusted from-

6.0 to -0.5 cm H2O below the baseline (PEEP) pressure. In order to initiate a spontaneous or assisted breath, the patient must generate -2.0 cm H2O. When the pressure drop is detected, an assisted breath is delivered.

The trigger automatically adjusts when the PEEP is changed.

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USING THE ZOLL VENTILATOR

Plateau Pressure

Press and hold the Manual Breath/Plateau Pressure button to perform a plateau pressure maneauver.

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Pressure Management

The following table gives the options and ranges for pressure management.

Parameter Window Options /

Range

Primary Value

Secondary Value

PIP

cm H2O

PEEP 0 to 30 AC Modes (ACV, SIMV, CPAP,

PS 0 to 60 Spontaneous Breaths

EPAP 3 to 30 Spontaneous Breaths

IPAP 6 to 60

10 to 80 Volume Target: Measurement

3 to 30

Availability/Notes Models

All

Pressure Target: Control Setting

PIP values greater than 60 cm H2O require the operator to perform a separate confirmation.

All

BL Modes

(SIMV and CPAP )

All

Alarm Limits High PIP 20 to 100 PEEP cannot be within 5 cm

O of the PIP High Limit

setting.

Low PIP 3 to 35, Off All

Measured Value

PIP Context Menu All

Breath Trigger

Mean Airway Pressure

MAP Paw Waveform 0 to 100 All

Default : -2

0 to 99.9 All

-6 to -0.5

Adjustment Increments: .5 All

All

(Assisted, Spontaneous)

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USING THE ZOLL VENTILATOR

FIO2 (Fraction of Inspired Oxygen) -- Oxygen Delivery Management

Pressing the FIO2 parameter button highlights the current FIO2 value and enables you to adjust it. There are no adjustable secondary parameters. The default values at start up is 21% whether

oxygen is present or not. If an FIO settings, the unit start ups with that saved FIO high-pressure oxygen is not present, the unit starts up with FIO PRESSURE LOW alarm is not activated. The seconda ry di splay i n the parameter wi ndow is O

Use1. This is the flow (liters/min) of high pressure oxygen used by the unit to support the patient at the current settings. O

sign next to the FIO oxygen use in the O

The following table lists the options and ranges for the FIO2 parameter:

value when this mode is active. (The “O2 Use” value does not include

Reservoir.)

value greater than 21% is saved and used for Power Up

value if high-pressure oxygen is present. If

= 21% and O2 SUPPLY

Reservoir mode is indicated on the display with a plus “+”

Parameter Window

Primary Value FiO2

Secondary Values

Alarm Limits

Not Applicable

Not Applicable All

Measured Values O2 Use (L/min)

FiO2 Context Menu

O2 Reservoir Default : off

Options /

Availability/Notes Models

Range 21 to 100 All breaths are delivered from

the compressor at 21%

All breaths are delivered from the High Pressure O2 Source at 100%

0 to 99.9

Off / On

Shows when High Pressure Oxygen Supply is present.

“+” icon indicates when “on” for low flow oxygen.

All

1. O2 Use = ((FIO2-0.21)/0.79)*Minute Volume where FIO2 is represented as a fraction and minute volume is the actual minute volume (controlled and spontaneous breaths * tidal volume).

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SpO2 -- Using the Pulse Oximeter

The primary use of the device is as a ventilator -- the pulse oximeter operates only when the device is providing ventilation.

The following conditions can affect the pulse oximeter reading:

• The sensor is too tight.

• There is excessive illumination from light sources such as a surgical lamp, a bilirubin lamp,

or sunlight.

• A blood pressure cuff is inflated on the same extremity as the one with a SpO2 sensor

attached.

• The patient has hypotension, severe vascoconstriction, severe anemia, or hypothermia.

• There is an arterial occlusion proximal to the sensor.

• The patient is in cardiac arrest or is in shock.

The SpO standby (and displays stby in the parameter window) when

display is active only when the pulse oximeter is connected. The pulse oximeter is in

• No SpO

• The sensor is off the patient during start up

• You place the pulse oximeter in standby

sensor is connected

Note: You can place the pulse oximeter in standby only when the probe is disconnected from

the patient. A valid signal automatically brings the pulse oximeter out of standby.

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USING THE ZOLL VENTILATOR

SpO2 Parameter Values

Pressing the SpO2 parameter button highlights the Low SpO2 Alarm Limit and enables its value to be changed. The default low SpO the same Context Menu as the HR parameter.

The following table gives the options and ranges for the SpO2 parameter:

Parameter Window Options /Range Availability/Notes Models

value at start up is 94%. The SpO2 parameter uses

Primary Value SpO2

84 to 100

Secondary

Not Applicable

Values

Alarm Limits Low Limit

Measured Values

Pleth Waveform

86 to 99, Off

SpO2 Context Menu (note same

as HR Context Menu) Pulse Ox Default :

Standby

Standby, Off, On

Fast SAT Default : Off Off/On

Measurement

Fast SAT enables rapid tracking of arterial oxygen saturation changes by minimizing the averaging. This mode is clinically applicable during procedures when detecting rapid changes in SpO

is paramount such as induction, intubation, and sleep studies.

All

Sensitivity Norm Max

APOD Off Off, On

Averaging 8 Seconds 2 to 4, 4 to 6,

8, 10, 12, 16

Norm adjusts the pleth signal sensitivity. Max interprets and displays data for even the weakest of signals. Max is recommended during procedures and when clinician and patient contact is continuous.

When on, this mode improves detection of the "probe off patient" condition, but reduces the ability to acquire a reading on patients of low perfusion.

Adjusts the SpO2 and HR averaging durations.

Seconds

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Signal Strength Measured

Value

0 to 20

Current signal strength value, not adjustable. A value of zero indicates that no measurement is available. This value helps clinicians place sensors on optimal sites

Signal IQ Measured

Value

Bar Graph

Bar graph displays the relative reliability of the pulse oximeter signal.

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USING THE ZOLL VENTILATOR

HR (Heart Rate)

The HR (Heart Rate) parameter window displays the patient’s heart rate when the pulse oximeter is working and the sensor is attached.

Pressing the HR parameter button highlights the High Heart Rate alarm limit and enables its value to be changed. Pressing the HR button a second time highlights the current value of the Low Heart Rate Alarm limit and enables its value to be changed. Both limits are adjustable by 1 b/min. The default value at start up for the high alarm limit is 120 BPM (Beats Per Minute); the low alarm limit is 40 BPM.

The following table gives the options and ranges for the HR parameter:

Parameter Window Options /

Range

Primary Value HR

Secondary Values Alarm Limits High Limit 80 to 240,

Measured Values

HR Context Menu (note same as SpO2 Context Menu)

% Not Applicable

Low Limit 30 to 79,

Pleth Waveform

0 to 240 Measurement - Heart Icon blinks

Off

Availability/Notes Models

at the beat rate.

All

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Managing Pop Up Messages

To prevent the setting of parameter values that are outside the typical cl inica l range of settings, the ventilator presents Pop Up messages that ask if you are sure you would like to set the parameter beyond the typical range.

When a message occurs, you are asked to press the Accept/Select button before you can adjust a parameter beyond the typical range. Pop Up messages are also used to alert you that certain settings are not permitted. In addition, Pop Up messages can call for you to press Accept/Select to acknowledge that you are entering configurations where certa in alarms are being suppressed, turned “off”, and/or canceled.

We provide a comprehensive list of pop up messages in Chapter 5, “Alarms.”

Pop Up Message Example

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USING THE ZOLL VENTILATOR

Managing Alarms

The ZOLL Ventilator uses Smart Help™ messages that provide a comprehensive suite of alarms. Smart Help messages alert operators and guide their action s to resolve alarm conditions and ensure patient safety.

At the onset of an alarm, the scree n displays the alarm name and then a series of context-sensitive Smart Help messages, which describe the possible cause and resoluti on of that alarm. When multiple alarms occur, the unit prioritizes alarms and displays those alarms that indicate the greatest risk to the patient first.

Smart Help Example

The previous illustration provi des an exa mple of what the device di spla ys when there are several alarms. The displayed Alarm message corresponds to the dark alarm bell at the bottom of the display. You can cycle through the various alarms by turning the ventilator’s selection dial. If there are less than 5 alarms, this alarm list also includes a “plot” icon, where the alarm screen is replaced by the Pulse Pleth/Time and Pressure/Time plots.

We describe A la rms in det ai l in Chap ter 5, “Alarms” and provide a comprehensive reference.

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Smart Help Messages

At the onset of an alarm, the Alarm Message Center (AM C) in the upper left-hand corner of the device’s LCD screen displays a Smart Help message. The Smart Help message displays the alarm name with a series of messages to help the operator resolve the alarm. The AMC indicates the number of active alarms as a series of Alarm Bell icons at the bottom with each bell indicating an active alarm. The ventilator prioritizes alarms and displays the alarm indicating the greatest risk first. All messages are context-based and suggest what is causing the condition and how it can be resolved.

Smart Help Display

Smart Help messages contain the information and instructions for all active alarms, such as in the previous example:

a. Alarm Name: Describes the nature and/or cause of the fault or failure. The Alarm

Name appears at the top of the AMC. When more than one alarm occurs at the same time, the unit prioritizes them based on patient safety.

b. Mitigation/Resolution Instructions: Instructions for the operator as to how the

alarm state may be resolved.

c. If not Resolved Instructions area: Instructions for the operator on what to do if

they cannot resolve the alarm state. The instruct ion is always shown in the following format **Message...**.

d. Alarm Icons: For each active alarm, an alarm bell appears. When multip le ala rms

are active, the number of bells corresponds to the number of alarms. The alarm in the AMC is demonstrated as the solid bell. To view each active alarm, turn the selection dial to scroll through all active alarms. If there are less then 5 alarms, the plot icon also appears.

e. Service Code: Each alarm has a 4 digit number associated with it, wh ich helps the

operator indicate the specific alarm when communicating with technical support.

f. Attention W arning Icon: Identifies the severity of the alarm: Low, Medium, or

High priority.

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USING THE ZOLL VENTILATOR

Alarm Priorities

Alarm priorities define the operational state of the device regarding its ability to provide mechanical ventilation. The alarm priority determines what effect pressing the MUTE/CANCEL button has. There are three priorities:

• High Priority: Mechanical ventilation under operator control is no longer possible. This

alarm category requires immediate intervention by the operator. This includes system failure alarms where the CPU has failed and a backup has taken over to sound the audible and visual alarms. It also includes when the device is turned on and there is no internal or external power source. Pressing the MUTE/CANCEL button has no affect on the High Priority alarm. The alarm can only be silenced by turning off the ventilator.

• Medium Priority: Mechanical ventilation is active or is possible (maybe for a finite period

of time), but there is a failure/fault with the patient, ventilator circuit, a pneumatic subsystem, or pulse oximeter. This alarm category requires immediate intervention by the operator. Pressing the MUTE/CANCEL button mutes Medium Priority alarms for 30 seconds. If after 30 seconds the alarm-causing condition still exis ts, the audible alarm recurs until it is muted again for another 30 second period or resolves.

• Low Priority (Advisory): Safe mechanical ventilation is active, but there is a fault that the

operator must be aware of to ensure safe management of the patient and/or ventilator. Low Priority alarms present themselves with both an audible and yellow LED alarm signal alerting the operator to the condition. Pressing the MUTE/CANCEL button cancels the audible signal. If the alarm is not resolved, the yellow LED remains illuminated to remind the operator of the fault or failure. You c an cancel some Low Priority alarms to avoid nuisance alarms.

If the alarms are Low Priority, then the Pleth and Pressure/Time plots appear permanently on the screen when the alarms are muted. If the alarms are Medium Priority, the unit cycles through each Medium Priority Alarm for a 20 second period. You can use the selection dial to select a particular Medium Priority Alarm and/or Plot for 20 seconds, after which the above cycling rotation resumes. New Alar ms can overwrite the screen at any time.

The first digit in the service code indicates the alarm priority:

1###: High Priority alarms 2###: Medium Priority alarms 3###: Low Priority alarms

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Silencing Alarms

The operator may decide, based on their clinical assessment, to silence certain alarms that, in the given situation, are considered “nuisance” alarms and do not assist in the safe management of the patient. Before any alarms can be silenced, the operator receives a Pop Up message asking them to confirm their understanding that the alarm is no longer available in the current operating session.

Alarm Preemptive Mute upon Power up

When the unit is first powered up, certain patient circ uit alarms are preempti vely muted for 120 seconds, to allow the operator time to get the patient circuit properly adjusted without nuisance alarms.

Note: During this preemptive mute of this audible alarm, the LED alarm light and alarm

message are still indicated.

There is a countdown timer located under the muted alarm symbol, showing how much time of the 120 seconds is remaining. The alarms that have this preemptive mute are:

Service Code Alarm Name

2062 Exhalation Fault

2070 Airway Pressure High

2071 Low Airway Pressure

2072 High Tidal Volume

2073 Low Tidal Volume

2074 High Breath Rate

2075 Low Breath Rate/Apnea

2076 Apnea

2090 PEEP Leak

2095 Insufficient Flow

2100 Patient Disconnect

2170 Spontaneous Breath-PIP High

2171 Spontaneous Breath-PIP Low

2172 Spontaneous Breath-V

2173 Spontaneous Breath-V

2300 Pulse Ox Module Failed

2301 Internal Communication Failed

2314 SpO2 Sensor Off Patient

2401 SpO2 Low

High

Low

2410 Heart Rate High

2411 Heart Rate Low (Pulse Rate Low)

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USING THE ZOLL VENTILATOR

Service Code Alarm Name

3300 SpO2 Shutdown (MS 11 Failure-Monitor Not In Use)

3301 SpO2 Shutdown (Communication Failure EMV-Pulse Ox-Monitor Not In

Use)

3310 No SpO2 Sensor Connected (No Sensor Detected)

3311 Defective Sensor

3312 SpO2 Pulse Search

3313 SpO2 Signal Interference

3315 Too Much Ambient Light

3316 Invalid SpO2 Sensor (Unrecognized Sensor)

3317 Low SpO2 Perfusion (Low Perfusion)

3318 Low SpO2 Perfusion (Poor SpO2 Signal

Turning Off Alarms at Extreme Range Limits

If the operator sets the following alarm limits to their extreme range, t he ventila tor turns of f the indicated alarms after Pop Up message confirmation:

1. High Breath Rate (Alarm #2074).

2. PIP Low (Alarms #207 1, 21 71) -- the d evice au tomati cally turn s off these alarm limits

in NPPV mode.

3. V

High (Alarms #2072, 2172) -- the device automatically tu rns off these alarm limits

in NPPV mode.

4. V

Low (Alarms #2073, 2173) -- the device automatically turns off these alarm limits

in NPPV mode.

5. Low SpO2 (Alarm #2410)

6. High Heart Rate (Alarm #2410)

7. Low Heart Rate (Alarm #2411)

If an alarm has been turned off and is then modified, but is not accepted, then the alarm parameter is set to the values indicated in the following table. This is done to ensure patient safety in the event of an inadvertent value change. You can change these values following the parameter change procedures described above.

High

Breath

PIP Low

VT High VT Low

Low SpO2

Rate

99 BPM 3 cm H2O 2000 ml 0 ml 86% 240 BPM 30 BPM

High

Heart Rate

Low Heart

Rate

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Alarm Cancellation in Alarm Configuration Menu

There are clinical situations where an alarm occurs, and in the ope rator’s clinical judgment, this alarm should be canceled for the remainder of the unit’s operating session. The following constraints apply to alarm cancellation:

1. Only alarms that have occurred in the current operating session can be canceled.

2. Alarms which have not occurred since turn on are indicated with a “--”.

3. Canceled alarms are not be saved in the User Settings for the next session.

4. All canceled alarms reappear (if appropriate) when the unit is next turned on. (As an

example, the Self Check Fault, calibration due Alarm # 3120, reappears in the next operating session.)

You may cancel the following alarms in the Alarm Configuration Menu:

1. Self Check Fault, calibration due (Alarm #3120)

2. RTC Battery Fault (Battery Low) (Alarm #3110)

3. Incomplete Exhalation (Alarm #3110)

4. PEEP Leak (Alarm #2090)

5. Fresh Gas Intake Fault (Alarm #3031)

• Patient Inspiratory Demand Not Met (Alarm #3092)

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USING THE ZOLL VENTILATOR

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Chapter 5

Alarms

This chapter provides a detailed description and comprehensive reference for the ZOLL Ventilator’s alarms and Pop Up Messages. This chapter

• Describes the display format of ZOLL’s Smart Help messages in detail.

• Describes alarm types and priorities.

• Provides a comprehensive list of alarms and Pop Up messages.

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ALARMS

Alarm Overview

To safeguard the patient, the ZOLL Ventilator continuously monitors the patient, device, and environment to ensure that all of the systems are functioning as intended. When device detects a problem, it triggers an alarm and displays a Smart Help message to alert you.

On the Smart Help message, a multi-line message screen appears in the upper left-hand corner of the display screen. This screen area is the Alarm Message Center (AMC). The AMC displays the alarm name with a series of messages to help you resolve the alarm. The device prioritizes alarms based on the risk to the patient and always presents the alarm with the greatest risk to the patient first. All messages are context-based and suggest what is causing the alarm and how it can be resolved.

The Alarm Message Center (AMC) contains the information and instructions for all active alarms, as in the following example:

Smart Help Alarm Display

a. Alarm Name: describes the type or cause of the alarm. The Alarm Name appears

at the top of the AMC. When more than one alarm occurs at the same time, the device prioritizes the alarms based on the highest risk to the patient.

b. Mitigation/Resolution Instructions: prioritized instructions that descri be how to

resolve the alarm state.

c. If not Resolved Instructions: Instructions on what to do you cannot resolve the

alarm state. The instruction is always shown in the following format **Message...**.

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d. Alarm Icons: For each active alarm, an alarm bell appears. When multip le ala rms

are active, the number of bells corresponds to the number of alarms. The alarm in the AMC is displayed as the solid bell. To view each active alarm, turn the Dial to scroll through all active alarms. The plot icon is also in this list. It allows you to see the current waveform to better assess the nature of the failure. A maximum of six alarms can be displayed without the plot icon.

e. Service Code: Each alarm has a 4 digit number associated with it, wh ich helps the

operator indicate the specific alarm when communicating with technical support. The service codes appear in the following format:

1### High Priority Alarm 2### Medium Priority Alarm 3### High Priority Alarm

f. Attention W arning Icon: Identifies the severity of the alarm: Low, Medium, or

High priority . See the Symbols tabl e in Chapter 1 for the appearance of the warning triangle for each of these three alarms.

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ALARMS

Alarm Priorities

Alarm priorities define the operation al status of the device and its abilit y to provide mecha nical ventilation. The alarm priorities are as follows:

High Priority

Mechanical ventilation under user control is no longer possible. This alarm priority requires immediate intervention. This includes system failure alarms where the CPU has failed and a backup has taken over to sound the audible and visual alarms. It also includes when the device is turned on and there is no internal or external power source.

Pressing the Mute button has no effect on a high priority alarm. The alarm can only be silenced by turning off the ventilator.

Medium Priority

Mechanical ventilation is active or is possib le (may be for a finite period of time) but, there is a failure or fault with the patient, ventilator circuit, a pneumatic subsystem, or pulse oximeter. This alarm priority requires immediate intervention by the user.

Pressing the Mute button mutes medium priority alarms for 30 seconds. If the alarm trigger still exists after 3 seconds, the audible alarm recurs until you mute it again for another 30 second period or the alarm is resolved.

Low Priority (Advisory)

Safe mechanical ventilation is active but, there is a fault that you must be aware of to ensure safe management of the patient or ventilator. Low priority alarms present with both an audible and yellow LED alarm signal alerting you to the condition. Pressing the Mute button cancels the audible signal. If the alarm is not resolved, the yellow LED remains illuminated to remind you of the fault or failure.

Note: Some Low Priority alarms are canceled and the Alarm LED turns green when you

push the Mute button. For others, the audible alarm is canceled but the Alarm LED stay yellow to remind you that the device is operating in a state that needs careful monitoring.

Popup Messages

These alerts appear whenever you attempt to adjust that device in a way that is outside clinical norms or is outside the performance range of the ventilator. Pop Up Messages also appear when you are required to confirm their action before you proceed.For example, if you try to set the low breath rate alarm below 4 that would, practically, disable the alarm. If the desired value is outside the performance range, the Pop Up message alerts you to why cannot make the change. (Example: trying to set the PEEP level greater than the PIP setting).

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Muting Alarms

Under most conditions, pressing the Mute button mutes the audible alarm for 30 seconds. As describe in the previous section, pressing the Mute button when a high priority alarm is active does not. Using the ZOLL Ventilator, muting functions as follows:

Preemptive Mute -- to prevent excessive noise in the patient care environment patient, safety alarms, such as Patient Disconnect, PEEP Leak, and so on, can be preemp tively muted for 30 seconds. This enables you to prevent the audible alarm, by pressing the Mute button, before initiating a procedure that could trigger an alarm.

2-Minute Startup Mute -- at start up, the ventilator suspends active patient safety alarms, with the exception of those alarms that could affect the performance of the devic e. This prevents nuisance alarms during start up while you configure the ventilator. When the Start Menu is used, the 2-minute countdown starts onc e you se lec t a start opt ion. Once the pati ent connected, the mute cancels automatically after 15 seconds when there are no active alarms.

Use in High Noise Environments -- in high noise environments, you may be inclined not to mute the alarm while addressing the problem. Not pressing Mute limits the user's ability to resolve the alarm because with each breath the alarm is retriggered and any parameter changes you are attempting are canceled as the alarm retriggers

Alarms Types

The ZOLL Ventilator’s alarm types provide a framework for you to see the scope and range of the alarms that the device uses. The alarm types are:

• Patient Safety -- Patient Safety Alarms address the ventilation of the patient and their

respiratory effort. Pulse oximetry monitoring and circuit/exhalation valve issues are also part of this group.

• Environment - Environment Alarms address the device inputs: external power, battery,

high pressure O2 supply, and the fresh gas intake. Ambient and device temperature, barometric pressure, and altitude are also part of this group.

• Self Check -- Self Check Alarms address the performance of the device systems and

include

2. Pneumatic Sensor: faults/failures of the pneumotachographs that measure gas flow or the

3. Pneumatic System: faults/failures of the compressor of O

4. Power System: faults/failures of the power system that render the device unable to operate

5. Pulse Oximeter (Ox) Module: faults/failures of the pulse oximeter module that are not related

6. Preventive Maintenance: alarms that occur when device is due for preventive maintenance.

Internal Communication (Comm): faults/failures of interdevice communication, cyclic redundancy checking, or processor-related issues

pressure transducers

from external power or charge/operate from the internal rechargeable battery.

to monitoring of the patient, a fault or failure of the module.

supply proportional valve.

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ALARMS

Alarm Groups

The following table displays the ZOLL Ventilator’s Alarm Groups:

Patient Safety Environment Self Check

Alarm Groups

Airway Pressure

-- High/Low

Apnea External Power

AutoPEEP Gas Intake

Breath Rate (BPM)

-- High/Low

Exhalation

-- Fault/Failure

Battery

-- Battery Drained

-- Battery Nearly Drained

-- Battery Low

-- Discharge Fault

-- Too Hot/Cold

-- Current High

-- DC Power Reversed

-- High

-- Low/Disconnect

-- Blocked

-- Restricted

O2 Supply

-- High/Low - Disconnect

Ambient Pressure

-- High/Low

Firmware Mismatch

Internal Comm

-- Fault/Failures

Pneumatic Sensor

-- Airway

-- Autocal

-- Pneumotach

-- Transducer

Pneumatic System

-- Compressor

-- O2 Valve

Heart Rate (HR)

-- High/Low

Inspiratory Demand Preventive Maintenance

Insufficient Flow Pulse Oximeter

Patient Detected Temperature

PEEP Leak

Power Cycle Needed

-- Comm Failure

-- Module Failure

-- High/Low

-- Sensor Failure

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SpO2

-- Low

-- Disconnect

-- Defective Sensor

-- Not Connected

-- Invalid Sensor

-- Light Contamination

-- Low Perfusion

-- Search

Tidal Volume

-- High/Low

Tubing Compliance

Alarm Groups

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ALARMS

High Priority Alarms

Service Code

1001

1002

Alarm Name/Mitigation/Resolution

Self Check Failure

Alarm triggers when the compressor fails to operate or fails to provide the flow required to deliver a breath and high pressure O

Mitigation/Info: Pneumatic System: Compressor, Manually Ventilate Patient, Connect 55 psig/380 kPa O2, Restart Ventilator with O2, **Contact Service Center**

Self Check Failure

Alarm triggers when communication between the compressor controller and Smart Pneumatic Module (SPM) is lost and high pressure O

Mitigation/Info: Pneumatic System: Compressor, Manually Ventilate Patient, Connect 55

is not available to provide ventilation.

1003

1010 Self Check Failure

1011

1012 Self Check Failure

1020 Low O2 Supply Failure

Self Check Failure

Alarm triggers when the flow from the first breath is ± 20% of the expected flow for the tidal volume at start up. This unusually low RPM is a symptom of a dirty flow screen which cannot be serviced by the user.

Mitigation/Info: Pneumatic Sensor: Pneumotach, Manually Ventilate Patient, **Contact Service Center**

Alarm triggers when the O this occurs the device automatically opens the exhalation valve to prevent pressure from accumulating in the

circuit and ventilation stops.

Mitigation/Info: Pneumatic System: O2 Valve, Manually Ventilate Patient, **Contact Service Center**

Self Check Failure

Alarm occurs when the signal to the O not available to provide ventilation.

Mitigation/Info: Pneumatic System: O2 Valve, Manually Ventilate Patient, **Contact Service Center**

Alarm occurs when the communication between the O available to provide ventilation.

Mitigation/Info: Pneumatic System: O2 Valve, Manually Ventilate Patient, **Contact Service Center**

Alarm occurs when the O port ventilation. If the O the device will not reestablish O pressure is between 40 and 87 psig (276 to 600 kPa) the user should check the hose connections for leaks.

Occasionally, this alarm can be caused by a regulator that provides a static pressure within range but is not able to provide the flow necessary to meet the patient flow demand.

Mitigation/Info: Manually Ventilate Patient, Connect 55 psig/380 kPa O2, Restart, Check O2 Supply for

valve fails in the open position which results in continuous inspiratory flow. When

valve is not delivering the required flow rate and the compressor is

valve and the SPM fails and the compressor is not

supply pressure is <35 psig (241 kPa) and the compressor is not available to sup-

source can be restored the device should be cycled off then on to reset. By design

operation unless the supply pressure is ≥40 psig (276 kPa). If the supply

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1030

Gas Intake Failure

Alarm occurs when the Fresh Gas/Emergency Air Inlet is blocked so that the compressor is not able to deliver flow sufficient for the current settings and high pressure O

is not available to support ventilation. The

user should clear the blockage and restart the ventilator. A false alarm can be triggered in very high vibration environments.

Mitigation/Info: Manually Ventilate Patient, Clear Blocked Intake, Connect 55 psig/380 kPa O2, Restart Venti-

1041

1051

1052

1060

High O2 Supply Failure

Alarm triggers when the O

supply pressure is >87 psig (600 kPa). Pressures above 87 psig (600 kPa) can

result in a catastrophic failure, harm to the patient and/or damage to the device. While the patient is manually ventilated the user or assistant should seek to reduce the O2 supply pressure. Sometimes this requires

changing the regulator which is not functioning as required. If the pressure cannot be reduced and a low flow device like a flow meter is available the user can provide supplemental O

via the optional low flow O2 reser-

voir. To clear the alarm the device should be turned off and then restarted with supply pressure in the appropriate range (40 to 87 psig, 276 to 600 kPa) or without the high pressure O2 source connected.

Self Check Failure

Alarm triggers when the autocal procedure is not able to zero the airway pressure transducer to ambient pressure. When this occurs, manually ventilate the patient, replace the ventilator replaced and contact the service center for additional information. Note: a false alarm can be triggered during operation in very high vibration environments when the device is not mounted correctly. If this could be the cause, restart the ventilator and continue operation if no alarms are triggered.

Mitigation/Info: Pneumatic Sensor: Autocal, Manually Ventilate Patient, **Contact Service Center**

Self Check Failure

Communication between the airway pressure sensor and SPM is lost. When this happens, manually ven-

tilate the patient, replace the ventilator and contact the service center for additional information. Mitiga-

tion/Info: Pneumatic Sensor: Airway Pressure, Manually Ventilate Patient, **Contact Service Center**

Exhalation System Failure

Alarm occurs when the PIP fails to return to the baseline pressure for 3 consecutive breaths, indicating that the exhalation control valve has failed. When triggered, the device stops ventilating and attempts to discharge the pressure in the breathing circuit to atmosphere. This failure may be caused by a significant blockage of the exhalation valve or an occlusion/kink in the exhalation valve tube. If possible, the user should replace the breathing circuit and restart the ventilator. If this does not resolve the failure, replace the ventilator and contact the service center for additional information.

Mitigation/Info: Patient Can Not Exhale, Manually Ventilate Patient, Check for Kinked Hose/Tube, Replace

1061

Exhalation System Failure

The airway pressure, PIP, is >40 cm H seconds, or when the PIP is >75 cm H

O, the PIP High Limit (when PIP High Limit is < 35 cm H2O) for > 5

O for > 1.5 seconds. When this happens, the device stops ventilating

and attempts to discharge the pressure in the breathing circuit to atmosphere. This failure may be caused by a significant blockage of the exhalation valve or an occlusion/kink in the exhalation valve tube. If possible, the user should replace the breathing circuit and restart the ventilator. If this does not resolve the problem, replace the ventilator and contact the service center for additional information.

Mitigation/Info: Patient Can Not Exhale, Manually Ventilate Patient, Check for Kinked Hose/Tube, Replace

1172

Self Check Failure

Alarm occurs when the 5 volt power bus fails to provide the required voltage. If this failure occurs, the user should manually ventilate the patient, replace the ventilator and contact the service center for additional information.

Mitigation/Info: Pneumatic Sensor: Autocal, Manually Ventilate Patient, **Contact Service Center**

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ALARMS

1173

1174

1175

1176

1420 Self Check: Complete Power Failure

Self Check Failure

Alarm occurs when communication fails between one of the subcomponents and the host processor. If this failure occurs, the user should manually ventilate the patient, replace the ventilator and contact the service center for additional information.

Mitigation/Info: Intern al COMM, Manually V entilate Patient, Backup Ventilator Started, **Contact Service

Self Check Failure

Alarm occurs when the device is not able to calibrate the one or more transducers and is no longer able to operate safely. If this failure occurs, the user should manually ventilate the patient, replace the ventilator and contact the service center for additional information.

Mitigation/Info: Pneumatic Sensor: Transducer, Manually Ventilate Patient, Restart Ventilator, **Contact Service Center**

Self Check Failure

Alarm triggers when the internal communication bus and the host are not able to communicate with the subassemblies. If this failure occurs, the user should manually ventilate the patient, replace the ventilator and contact the service center for additional information.

Mitigation/Infor: Internal COMM, Manually Ventilate Patient, **Contact Service Center**

Self Check Failure

Alarm triggers when the calibration file fails its integrity check. The user should manually ventilate the patient, replace the ventilator and contact the service center for additional information.

Mitigation/Info: Internal COMM, Manu a l ly V e n t ila t e Pa t i e nt, **Contact Service Center**

Alarm triggers when power is lost from both the internal battery and an external source during operation. When this occurs, the LCD blanks (no power for operation), the audible alarm pulses rapidly, and the visual alarm flashes rapidly. This alarm will last approximately two minutes. If the device can be recharged after the failure and there are no other issues it can be returned to service. If there are any questions, contact the service center for additional information.

1430 Drained Battery

Alarm triggers when the internal battery power drops below the amount required to provide ventilation and external power is not connected. When this occurs there is enough power to operate the user interface and provide information to the user. The user should be manually ventilate the patient while an external source of power is sought. To cancel the alarm and begin operation with external power the device must be turned off and then back on.

Mitigation/Info: Manually Ventilate Patient, Connect External Power, **Contact Service Center**

1471

1472 Self Check Failure

Self Check Failure

Alarm triggers when the device is no longer able to communicate with the User Interface Module (UIM) and the interface controls. When this occurs ventilation continues at the current settings or the backup mode settings and the high priority alarm sounds. The user should manually ventilate the patient, replace the ventilator and contact the service center for additional information.

Mitigation/Info: Internal COMM, Manually Ventilate Patient, **Contact Service Center**

Alarm triggers when the device is no longer able to communicate with the Smart Pneumatic Module (SPM). When this occurs ventilation continues at the current settings or the backup mode settings and the high priority alarm sounds. The user should manually ventilate the patient, replace the ventilator and contact the service center for additional information.

Mitigation/Info: Internal COMM, Manually Ventilate Patient, **Contact Service Center**

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1473 Self Check Failure

Alarm triggers when no valid data is sent from the SPM within 1 second. When this occurs ventilation continues at the current settings or the backup mode settings and the high priority alarm sounds. The user should manually ventilate the patient, replace the ventilator and contact the service center for additional information.

Mitigation/Info: Internal COMM, Manually Ventilate Patient, **Contact Service Center**

1474

1475

1480

Self Check Failure

Alarm triggers when cyclic redundancy checking between the device and SPM fails. When this occurs ventilation continues at the current setting or the backup mode settings and the high priority alarm sounds. The user should manually ventilate the patient, replace the ventilator and contact the service center for additional information.

Mitigation/Infor: Internal COMM, Manually Ventilate Patient, **Contact Service Center**

Self Check Failure

Alarm triggers when the device has lost communication with the contrast control and in most instances the content of the LCD is not visible. When this occurs ventilation continues at the current settings or the backup mode setting and the high priority alarm sounds. The user should manually ventilate the patient, replace the ventilator and contact the service center for additional information.

Mitigation/Info: Intern al COMM, Manually Ventilate Patient, Backup Ventilator Started, **Con tact Service Center**

Self Check Failure

Alarm triggers when the device and SPM software loads are not compatible. This alarm is typically associated with an SPM change where the technician failed to update the device and SPM to the current software revision. Ventilation is provided using the backup mode settings. The user should manually ventilate the patient, replace the ventilator and contact the service center for additional information.

Mitigation/Info: Firmware Mismatch, Manually Ventilate Patient, Software Compatibility Failure, **Contact Service Center**

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ALARMS

Medium Priority Alarms

2001 Self Check Fault

Alarm triggers when the communication between the compressor and the SPM fails and high pressure O available to provide ventilation. The alarm will continue to sound as a medium priority alarm until the user

acknowledges that ventilation is being provided using O changes to low priority. While operating in this state the user should ensure an adequate supply of O2. Fail-

ure to maintain the O

Mitigation/Info: Pneumatic System: Compressor, Operation Switched to O2 Supply, Set FIO2 to 100%, Moni-

2002

Self Check Fault

Alarm triggers when the communication between the O able to provide ventilation. The alarm will continue to sound as a medium priority alarm until the user

acknowledges that ventilation is being provided using the compressor by setting the FIO the alarm priority changes to low. While operating in this state the user should monitor the SpO2 to ensure that adequate oxygenation is maintained. If low flow O Gas/Emergency Air Intake port using the optional O

supply up or down to increase or decrease the amount of O2 delivered to the patient.

Mitigation/Info: Pneumatic System: Compressor, Operation Switched to O2 Supply, Set FIO2 to 100%, Moni-

2011 Self Check Fault

Alarm triggers when the signal to the O the compressor is available to provide ventilation. The medium priority alarm will continue until the user

acknowledges that ventilation is being provided using the compressor by setting the FIO2 to 21%. At this time the alarm priority changes to low priority. While operating in this state the user should monitor the SpO ensure that adequate oxygenation is maintained. If low flow O Fresh Gas/Emergency Air Intake port using the optional O adjusting the O2 supply up or down to increase or decrease the amount of O2 delivered to the patient.

Mitigation: Pneumatic System: O2 Valve, Operation Switched to Compressor, Connect Low Flow O2, Monitor

2012 Self Check Fault

Alarm triggers when the communication between the O2 valve and the SPM fails and the compressor is available to provide ventilation. The alarm will continue to sound as a medium priority alarm until the user

acknowledges that ventilation is being provided using the compressor by setting the FIO2 to 21%. At this time the alarm priority changes to low. While operating in this state the user should monitor the SpO that adequate oxygenation is maintained. If low flow O Gas/Emergency Air Intake port using the optional O O2 supply up or down to increase or decrease the amount of O2 delivered to the patient.

Mitigation/Info: Pneumatic System O2 Valve, Set FIO2 To 21%, Connect Low Flow O2, Monitor SpO2

supply will result in a high priority alarm.

by setting the FIO2 to 100%. At this time the priority

valve and the SPM fails and the compressor is avail-

to 21%. At this time

is available it can be entrained through the Fresh

reservoir. Maintain an acceptable SpO2 by adjusting the

valve is outside of the calibration range for the required flow rate and

is available it can be entrained through the

reservoir. Maintain an acceptable SpO2 by

to ensure

is available it can be entrained through the Fresh

reservoir. Maintain an acceptable SpO2 by adjusting the

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2020 Low O2 Supply Fault

Alarm triggers when the O tilation. When this occurs the device begins ventilation using the compressor. The alarm will continue to

sound as a medium priority alarm until the user acknowledges that ventilation is being provided using the compressor by setting the FIO

The device works with or without external O2. If O2 is connected the device will not continue O2 operation unless the supply pressure is ≥40 psig (276 kPa). This is done to prevent continuous cycling between alarms

during the inspiratory phase and no alarm during the expiratory phases. If low flow O entrained through the Fresh Gas/Emergency Air Intake port using the optional O acceptable SpO2 by adjusting the O2 supply up or down to increase or decrease the amount of O2 delivered

to the patient.

2030 Gas Intake Fault

Alarm triggers when the Fresh Gas/Emergency Air Inlet is blocked so that the compressor is not able to deliver a breath within ±10% of the current settings and high pressure O

When this occurs the ventilator immediately switches to O the FIO set the FIO

to 100% to acknowledge that the patient is being ventilated at 100%, clear the blockage and then

back to the original value. Once the blockage has been cleared operation with the compressor

will restart. If the blockage cannot be cleared, the alarm will resound, continue ventilation with FIO2 set to 100% and ensure an adequate supply of O necessary, the user can activate the O press the alarm.

2053 Self Check Fault

Alarm triggers when the expiratory time is <170 ms for 3 consecutive breaths. When this occurs the device attempts to reestablish a baseline by momentarily setting PEEP to 0 cm H

breaths. This interruption lasts no longer than 2 breath cycles. The user should also check for leaks in the hose and tubes, patient airway and exhalation valve. If recalibration is successful the alarm will automatically cancel. If the device does not reset, manually ventilated the patient, replace the ventilator and contact the service center for additional information.

Mitigation/Info: Pneumatic Sensor: Airway Pressure, Check Circuit for Leaks/Disconnects, , Check Tube

2062 Exhalation System Fault

Alarm triggers when the airway pressure, PIP, measured at the end of expiration is >5 cm H

baseline pressure, PEEP. This is typically caused by a restriction of the exhalation valve or an occlusion/kink in one or more of the breathing circuit tubes or hose. If the breathing circuit tubes appear to be intact the circuit should be replaced to eliminate the possibility of a bad exhalation valve. If the condition does not resolve the user should manually ventilate the patient, replace the ventilator and contact the service center for additional information.

Mitigation/Info: Check Patient Exhalation, Check Circuit for Kinked Hose/Tube, Check for Blocked Exhalation

2070 Airway Pressure High

Alarm triggers when the airway pressure, PIP, is > the high airway pressure limit for 2 consecutive breaths. When the limit is reached, the flow decelerates to keep the PIP below the airway pressure for the duration of the breath (inspiratory time). The user should check for kinks or blockage of the breathing circuit, exhalation valve or patient airway. In some instances the cause can be an accumulation of secretions in the airway which will require suctioning to clear. The user should also assess if the patient is fighting the ventilator, asynchrony, or if the high airway pressure limit is set too low.

Mitigation/Info: Pressure Exceeds Limit Setting, Check Circuit for Kinked Hose/Tube, Check fo r Airway

supply pressure is <35 psig (241 kPa) and the compressor is able to support ven-

to 21%. The alarm will cancel completely when the user sets to 21%. NOTE:

is available it can be

reservoir. Maintain an

is available to support ventilation.

powered ventilation. To clear the alarm first set

. NOTE: A high vibration environment can trigger this alarm. If

Reservoir Mode while continuing to operate normally. This will sup-

O and suspending triggered

O above the

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ALARMS

2071 Low Airway Pressure

Alarm triggers when the airway pressure, PIP, is < the low airway pressure limit for 2 consecutive breaths. The user should check for leaks/disconnects in the breathing circuit, patient airway or a failure of the exhalation valve. The user should also assess if the patient is breathing with the ventilator, the PIP or tidal volume are set too low, or if the low airway pressure limit is set too high. If a replacement is available the user should replace the breathing circuit. If these mitigations do not resolve the alarm condition, replace the ventilator and contact the service center for more information.

Mitigation/Info: Check Patient Connection, Check Circuit For Loose Hose/Tube, Check Exhalation Valve,

2072 High Tidal Volume

Alarm triggers during pressure targeted ventilation when the delivered tidal volume exceeds the user defined limit for 2 consecutive breaths. This can be caused by a leak in the patient connection or breathing circuit. When the ventilator is not able to reach the pressure target flow increases to compensate which leads to a high delivered tidal volume. It is critical to set this alarm with infant and pediatric patients given that the high resistance airways used with these patients can provide a false airway pressure even when the patient has extubated or decannulated. The user should check for leaks/disconnects in the breathing circuit, patient airway or a failure of the exhalation valve. Users should also assess if the patient is anxious and breathing deeply or if the high tidal volume limit is set too low. If a replacement is available the user should replace the breathing circuit.

Mitigation/Info: Check Patient Connection, Check Circuit For Loose Hose/Tube, Check Exhalation Valve,

2073 Low Tidal Volume

Alarm triggers during pressure targeted ventilation when the delivered tidal volume does not reach the user defined limit for 2 consecutive breaths. When this occurs flow decelerates to maintain the airway pressure at airway pressure limit for the duration of the breath (inspiratory time). If the PIP setting is set properly the breath should be greater than the low limit, provided it is set correctly. The user should check for kinks or blockage of the breathing circuit or patient airway. In some instances the cause can be an accumulation of secretions in the airway which will require suctioning to clear. The user should also assess if the patient is fighting the ventilator, asynchrony, or if the PIP target is set too low.

Mitigation/Info: Check Circuit For Kinked Hose /Tube, Check For Airway Obstruction, Suction Airway If Nec-

2074 High Breath Rate

Alarm triggers when the actual breathing rate (set rate plus spontaneous patient rate) exceeds the high alarm limit. This can be caused by the patient breathing too fast due to anxiety or pending respiratory failure. It can also be caused by autotriggering due to a leak or the when the spontaneous/assisted breath trigger is set too close to the baseline pressure, PEEP. The user should check for leaks/disconnects in the breathing circuit, patient airway or a failure of the exhalation valve. The user should also assess if the patient is anxious and breathing deeply or if the high tidal volume limit is set too low. If a replacement is available the user should replace the breathing circuit.

Mitigation/Info: Check For Loose Circuit Connection, Check Trigger Setting, Check High Alarm Limit Setting,

2075 Low Breath Rate/Apnea

Alarm triggers when the actual breathing rate (set rate plus spontaneous patient rate) is less than the low alarm limit. This can be caused by the patient not breathing or breathing at a rate less than the limit. If the spontaneous/assisted breath trigger is not sensitive enough the patient may not be able to trigger breaths. The user should also determine if the low rate is set too high for the patient.

Mitigation/Info: Check Patient for Spontaneous Breathing, Adjust Breath Trigger, Check Low Alarm Limit Set-

2076 Apnea

ting, Increase Ventilation Support, ** Manually Ventilate Patient**

Alarm triggers when the spontaneous breathing rate is less than the low alarm limit. This alarm only occurs in noninvasive ventilation, CPAP and BL modes. The alarm can be caused by the patient not breathing or breathing at a rate less than the limit. The apnea backup ventilation starts automatically when the alarm is triggered. The user should select and active mode of ventilation, AC or SIMV, to support the patient.

Mitigation/Info: Apnea Backup Ventilation Started, Set Mode to AC or SIMV, Set Rate and Tidal Volume/ Pressure Target, ** Manually Ventilate Patient**

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2090 PEEP Leak

Alarm triggers when the airway pressure drops below the PEEP setting by 2 cm H phase of the breath. This can be caused by a leak in the breathing circuit, exhalation valve or patient airway.

The user should check the breathing circuit and exhalation valve to ensure that all connections are tight. If the circuit appears damaged or is suspect it should be replaced. The user should also check if there is a cuff leak from the patient’s airway or mask. If these mitigations do not resolve the alarm the user can choose to use leak compensation to provide additional flow during the expiratory phase to compensate for the leak. If you still cannot compensate for the leak, consult the attending physician. If this fails replace the ventilator and contact the service center for more information.

2095 Insufficient Flow

Alarm triggers when the pressure target is not reached during the inspiratory period during pressure targeted ventilation. Typically this can occur when the Rise Time is set too low for the patient and their respiratory mechanics. Decrease the Rise Time and check the circuit and exhalation valve for leaks or disconnects. If the flow cannot be adjusted appropriately then the patient should be ventilated using volume targeted ventilation.

Mitigation/Info: Pressure Target Not Met, Decrease Rise T ime , Press/Hold BPM Button, Consult Physician, ** Ventilate With Volume Target**

2100 Patient Disconnect

Alarm triggers when the airway pressure fails to exceed the PEEP setting by ~7 cm H the user should quickly check the patient connection, breathing circuit connections and the exhalation valve.

At times this alarm can be caused by the patient breathing with the ventilator during inspiration which prevents the PIP from passing the minimum pressure. While resolving the alarm condition the user should be sure to manually ventilate the patient.

Mitigation/Info: Check Patient Connection, Check Circuit for Loose Hose/Tube, Check Exhalation Valve, Check Patient, Replace Circuit, **Manually Ventilate Patient**

O during the expiratory

O. When this occurs

2110 Patient Detected

An alarm triggers when you connect the patient to the ventilator while the Start Menu is still active. To resolve the alarm, you must select a mode of ventilation and configure the device appropriately for the patient. In addition, you should perform the Operational Test procedure before reconnecting the patient to the device.

Mitigation/Info: Backup Ventilation Started, Set Mode (AC, SIMV, CPAP, BL), Configure Other Settings, **Manually Ventilate Patient and Restart**

2170 Spont. Breath PIP High

Alarm triggers when the airway pressure, PIP, exceeds the High PIP Limit Setting during 2 consecutive spontaneous breaths. The user should quickly check for kinked hoses/ tubes and check for airway obstruction. Suctioned the patient if necessary. The user should also check if the High PIP limit is set correctly of if the pressure support (PS) level is set too high. While resolving the alarm condition the user should be sure to manually ventilate the patient.

Mitigation/Info: Pressure Exceeds Limit Setting, Check Circuit for Kinked Hose/Tube, Check fo r Airway Obstruction, Suction Airway if Necessary, Check High Limit Setting, **Manually Ventilate Patient**

2171 Spont. Breath PIP Low

Alarm triggers when the airway pressure, PIP, exceeds the Low PIP Limit Setting during 2 consecutive spontaneous breaths. The user should quickly check circuit for loose hoses/ tubes and also check the exhalation valve and the tube placement/ cuff. The user should also check if the Low PIP Limit is set correctly. While resolving the alarm condition the user should be sure to manually ventilate the patient.

Mitigation/Info: Check Patient Connection, Check Circuit for Loose Hose/Tube, Check Exhalation Valve, Check Tube Placement/ Cuff, Check Low Limit Setting, **Manually Ventilate Patient**

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ALARMS

2172 Spont. Breath Vt High

Alarm triggers when the high VT Limit is exceeded during 2 consecutive spontaneous breaths. The user should check: the patient connection, airway placement, breathing circuit for loose hoses/ tubes and also check the exhalation valve. The user should also check if the High VT Limit is set correctly. While resolving the alarm condition the user should be sure to manually ventilate the patient.

Mitigation/Info: Check Patient Connection, Check Circuit for Loose Hose/Tube, Check Exhalation Valve, Check Tube Placement/ Cuff, Check Limit Setting, **Monitor Patient**

2173 Spont. Breath Tt Low

Alarm triggers when the Low VT Limit Setting is not achieved during 2 consecutive spontaneous breaths. When this occurs, the user should quickly check for kinked hoses/ tubes and check for airway obstruction. The patient should be suctioned if necessary. The user should also check if the Low VT limit is set correctly. While resolving the alarm condition the user should be sure to manually ventilate the patient.

Mitigation/Info: Check Circuit f o r Kinked Hose/Tube, Check for Airway Obstruction, Suction Airway if Necessary, Check Low Limit Setting, **Manually Ventilate Patient**

2300 Self Check Fault

Alarm triggers when the pulse oximeter module fails while in use. The user cannot resolve the fault. When the alarm is active “-- --” displays in the HR and SpO

audible alarm for 30 seconds. To resolve the alarm, remove the probe from the device and put the pulse oximeter in standby “stby”. Contact the service center for additional information.

Mitigation/Info: Pulse Ox Module, Internal Failure, SpO2/HR Not Available from Pulse Ox, Turn Off Pulse Ox,

windows. Pressing the Mute/Cancel button silences the

2301 Self Check Fault

Alarm triggers when the communication between the pulse oximeter module and device fails. When this occurs the user must turn off the pulse oximeter monitor to end the alarm condition through the SpO

menu while also removing the probe from the device. When this is done “stby“ appears in the parameter windows for SpO

and HR as those parameters are no longer available. When appropriate the user should

replace the ventilator and contact the service center for additional information.

Mitigation/Info: Internal COMM: Pulse Ox Module, SpO2/HR Not Available from Pulse Ox, Turn Off Pulse Ox, Remove SpO2 Cable from Ventilator, **Contact Service Center**

2314 Pulse Ox Sensor Off Patient

Alarm triggers when an operating sensor loses the patient signal. The most common cause is when the sensor disconnects from the patient or is misaligned with the sensor site. This alarm can also be caused by poor perfusion at the sensor site which doesn’t provide an adequate signal. In these cases try another site. Replace the sensor if another sensor is available. If the alarm condition cannot be resolved the user should remove the sensor from the patient and put the pulse oximetry monitor in standby “stby”.

Mitigation/Info: Check Pulse Ox Sensor Site, Check Patient for Peripheral Pulse, Change Placement, Check Sensor Operation, Replace Sensor,**Turn Off Pulse Ox Monitorin g**

2401 SpO2 Low

Alarm triggers whenever the SpO2 value drops below the Low SpO2 Limit. The default value for the limit is 94%. Corrective actions are increasing oxygenation by increasing the FIO only be changed based on consultation with the attending physician. When using low flow O2 the user should increase the flow of O

to the low flow O2 reservoir.

Mitigation/Info: SpO2 Below Limit, Increase FIO2, Check O2 Supply, Increase PEEP Per Physician, **Con-

2410 Heart Rate High

Alarm triggers when the heart rate is greater than the High Heart Rate Limit. The default value for the limit is 120 beats/minute. The user should consult with the attending physician on how best to reduce the heart rate to an acceptable level.

Mitigation/Info: Heart Rate Above Limit, Check High Limit Setting, **Consult Physician**

Context

or PEEP settings. PEEP should

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2411 Heart Rate Low

Alarm triggers when the heart rate is less than the Low Heart Rate Limit. The default value for the limit is 40 beats/minute. The user should consult with the attending physician on how best to increase the heart rate to an acceptable level.

Mitigation/Info: Heart Rate Below Limit, Check Low Limit Setting, **Consult Physician**

2421 Self Check Fault

Alarm triggers when there is a failure of the input protection circuit and the device is able to operate. The alarm will continue until the device is turned off. The user can mute the alarm for 30 seconds by pushing the MUTE/CANCEL button. The user should replace the ventilator and contact the service center for additional information.

Mitigation/Info: Power System, Power System Needs Repa ir, Internal Battery Oper at ion, Monitor B attery %

2423 Self Check Fault

2430 Nearly Drained Battery

Charge, **Contact Service Center**

Alarm triggers when the internal power circuit has failed and external power is connected but cannot be used. The fault cannot be repaired by the user. Pressing the Mute/Cancel button silences the audible alarm for 30 seconds. Replace the ventilator and contact the service center for additional information.

Mitigation/Info: Power System, Power System Needs Repa ir, Internal Battery Oper at ion, Monitor B attery % Charge, **Contact Service Center**

Alarm triggers when the device detects that there is ≤5 minutes of battery operation remaining and external power is not connected. The user should immediately seek a source of external power and/or plan to provide manual ventilation. Attaching external power will immediately clear the alarm though a low priority alarm will remain until the internal battery has recharged so that the device can provide 30 minutes of operating time. This will take approximately 5 to 10 minutes. If recharging the battery does not resolve the issue, contact the service center for additional information.

Mitigation/Info: <5 Minutes Operation, Connect External Power, Ensure Ability to Manually Ventilate, ** Con-

2450 Battery Discharge Fault

Alarm triggers when the battery temperature reaches 70 °C (158 °F) which is 5 °C from its maximum operating temperature using the internal battery and external power is not connected. When the battery temperature reaches 75 °C (167 °F) the battery will shut down to prevent failure and the device will sound a high priority alarm and shutdown. If possible the user should provide a source of external power which will allow operation to continue at the current and higher temperatures. In addition, the device should be removed from the soft case which acts as insulation. Shading the patient and ventilator from direct sunlight may also help reduce the battery temperature.

Mitigation/Info: Battery Within 5 °C of High Limit, Remove Padded Case, Ensure External Power Avail able,

2455 Battery Fault

Ensure Ability to Manually Ventilate, **Move To Cooler Location**

Alarm triggers when the device is not able to communicate with the internal battery. When this occurs the device does not know the current charge of the battery and operation could stop at any time. To continue operation and the user should connect external power and ensure the ability to manually ventilate the patient. When external power is connected the alarm priority decreases to Low Priority, replace the ventilator and contact the service center.

Mitigation/Info: Battery Communication, Connect External Power, Ensure Ability to Manually Ventilate Patient , **Contact Service Center**

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ALARMS

Low Priority Alarms

Service Code

3001

Alarm Name/Mitigation/Resolution

Self Check Fault

Alarm triggers when the compressor fails to operate or fails to provide the flow required to deliver a breath within ±10% of the current settings, high pressure O

set the FIO ure to maintain the O

replace the ventilator and contact the service center for additional information.

Mitigation: Pneumatic System Compressor, Ensure 55 psig/380 kPa O2, O2 Operation Only, **Contact

to 100%. While operating in this state the user should ensure an adequate supply of O2. Fail-

is available to provide ventilation and the user has

supply will result in a high priority alarm. The user cannot repair the compressor,

3002

3011

3012

Self Check Fault

Alarm triggers when communication between the compressor controller and SPM is lost, high pressure O2 is available to provide ventilation and the user has set the FIO user should ensure an adequate supply of O

. Failure to maintain the O2 supply will result in a high priority

to 100%. While operating in this state the

alarm. The user cannot repair the device, replace the ventilator and contact the service center for additional information.

Mitigation: Pneumatic System: Compressor, Ensure 55 psig.380 kPa O2 Supply, O2 Operation Only, **Contact Service Center**

Self Check Fault

Alarm triggers when the signal to the O

valve is outside of the calibration range for the required flow rate,

the compressor is available to provide ventilation and the user has acknowledged that ventilation is being provided using the compressor by setting the FIO2 to 21%. While operating in this state the user should

monitor the SpO entrained through the Fresh Gas/Emergency Air Inlet port using the optional O

to ensure that adequate oxygenation is maintained. If low flow O2 is available it can be

reservoir. Maintain an

acceptable SpO2 by adjusting the O2 supply up or down to increase or decrease the amount of O2 delivered to the patient. The user cannot repair the O

valve, replace the ventilator and contact the service center for

additional information.

Self Check Fault

Alarm triggers when communication between the O able to provide ventilation and the user has set the FIO

valve and SPM is lost, the compressor is avail-

to 21%. While operating in this state the user

should monitor the SpO2 to ensure that adequate oxygenation is maintained. If low flow O2 is available it can be entrained through the Fresh Gas/Emergency Air Inlet port using the optional O voir. Maintain an acceptable SpO amount of O

delivered to the patient. The user cannot repair the O2 valve, replace the ventilator and

by adjusting the O2 supply up or down to increase or decrease the

reser-

contact the service center for additional information.

Mitigation/Info: Pneumatic System: O2 Valve, Compressor Operation Only!, Keep FIO2 at 21%, Con-

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3030

Gas Intake Fault

Alarm triggers when the Fresh Gas/Emergency Air Inlet is blocked so that the compressor is not able to deliver breaths within ±10% of the current settings, high pressure O

the user has set the FIO inal value. If the blockage is cleared operation with the compressor will restart. If the blockage is not

cleared, the alarm will resound, set the FIO2 to 100%, continue ventilation and ensure an adequate supply

. It is possible for this alarm to be a false alarm that is triggered in a very high vibration environment or

of O

if the device is not mounted correctly. If the alarm does not resolve contact the service center for additional information.

Mitigation/Info: O2 Supply Operation, Clear Blocked Intake, Reset FIO2 to Previous, Monitor SpO2, **Con-

3031

Intake Restricted

Alarm triggers when the Fresh Gas/Emergency Air Inlet is blocked but is still capable of delivering breaths within ±10% of the current settings. This could be caused by an external blockage or a dirty/wet external or internal filter. If the blockage is cleared the alarm will automatically cancel. Refer to instructions for changing the internal filters. If the problem does not resolve contact the service center for additional information. On rare occasions, this alarm can be triggered by a patient with a very high inspiratory demand. In this case increase the rise time or shorten the inspiratory time to increase the inspiratory flow rate.

Mitigation/Info: Clear Fresh Gas Intake, Check Filter for Moisture or Dirt, OR, Manage Settings / Inspiratory Demand, **Manually Ventilate Patient**

3032 Self Check Fault

Alarm triggers when communication between the Fresh Gas/Emergency Air Inlet pressure sensor is lost. Normal operation can continue but, if the condition is not cleared by powering off and restarting the device should be replaced when appropriate as. When used during this alarm condition the user should be sure to keep the Fresh Gas/Emergency Air Inlet clear and ensure that external filters are checked regularly.

Mitigation/Info: Pneumatic Sensor, Ventilator Operating, Unable to Detect Inlet Obstruction, **Contact Ser-

is available to support ventilation and

to 100%. To clear the alarm, clear the blockage and set the FIO2 back to the orig-

3041 High O2 Supply Fault

Alarm triggers when the high pressure O automatically cancels when the supply pressure is <80 psig (552 kPa). Pressure above 87 psig (600kPa) could

result in a catastrophic failure, harm to the patient and/or damage to the device. The user should reduce the O2 supply pressure, sometimes this requires replacing the regulator that is not functioning correctly. If the

pressure cannot be reduced and a low flow device like a flow meter is available the user can provide supplemental O2 via the optional low flow O2 reservoir. If not, the user should monitor the O2 supply pressure and

ensure that the pressure does not rise further.

Mitigation/Info: Decrease O2 Supply Pressure, Replace Regulator, Connect Low Flow O2, Monitor SpO2

3073 Tubing Compliance Fault

Alarm is triggered when the tubing compliance correction shows that it is >the set tidal volume indicating that the patient may not be receiving the appropriate tidal volume. In this case the user should assess the patient and settings. Consult the attending physician if there are questions about how to configure the ventilator correctly to support the patient.

Mitigation/Info: Calculated Compliance Volume Larger than Delivered Volume, Check Tubing Compliance vs. Circuit

3091 AutoPEEP

Alarm triggers when the exhaled flow from the patient continues throughout the expiratory period causing the expiratory control valve to cycle throughout the period to maintain the baseline pressure. When this occurs the user should increase the expiratory period by decreasing the inspiratory time, decreasing the breathing rate or both. The physician should also be consulted as this alarm is an indication that Auto-PEEP is occurring. Note: at startup, this alarm is off. The user can choose to activate the alarm if they believe the patient is at risk of Auto-PEEP using the Alarm Configuration submenu that is access using the Main Menu.

Mitigation/Info: Increase Expiratory Time, Decrease Inspiratory Time, Decrease Respiratory Rate, Disable

supply is ≥80 psig (552 kPa) and <87 psig (600 kPa). The alarm

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ALARMS

3092 Inspiratory Demand

Alarm triggers when the end-inspiratory pressure is < -1.0 cm H due to changes in the patient’s status, where the patient attempts to inhale more gas than what is currently set.

When this occurs, the user should note if the patient is breathing or fighting with the vent. The user should increase the flow rate (by decreasing the inspiratory time) and/or reduce the rise time. The physician should be consulted.

Mitigation/Info: Patient May be Breath ing with the Ventilator, Increase I Time and/or Decrease Rise Time, Check Patient and Circuit for Leaks, Disable Alarm, **Consult Physician**

3110 RTC Battery Low

Alarm triggers when the real-time clock (RTC) battery is < ~2.5 volts. The alarm condition is checked at start up and if this alarm occurs the device is safe to operate but the user should replace the device when appropriate and consult the service center for additional information. The user cannot change the RTC battery. The RTC battery provides power for the clock that tracks the local time. It is replaced every 4 years during preventive maintenance.

Mitigation/Info: Vent Fully Functional, **Contact Service Center**

3120 PM Due

Alarm triggers at start up when the preselected number of days has elapsed since the last calibration. When appropriate the device should be replaced and sent for preventive maintenance. The low priority message serves as a reminder. Calibration is due every 365 days or 730 days for devices configured for stockpile use (check with your organization regarding the configuration of your device). Users should schedule the device for service as soon as possible. Users can suspend the yellow alarm notification for the current use by turning the alarm off using the Alarm Configuration submenu in the Main Menu.

Mitigation/Info: Preventive Maintenance Due, Ventilator Functioning with No Faults, **When Appropriate, Con-

O for 3 consecutive breaths. This can occur

3121 Power Cycle Need

This alarm occurs when the device has been running continuously for 30 days. In order to check the flow pneumotach, which is done a startup, the user should manually ventilate the patient and cycle the power. Once this is done the user can select the Last Settings options from the Start Menu and continue operation if not faults are detected during the self check. If nonoperating alarms occur, contact the service center for additional information.

Mitigation/Info: Power-on Self Checks are Due, When Appropriate, Power Off Then On, Verify Proper Settings, **Review Manual For Additional Information**

3130 Self Check Fault

Alarm triggers when the ambient pressure transducer fails. When this occurs, the device is no longer able to automatically compensate for changes in altitude especially in situations where the ambient pressure could change rapidly as during transport by air. When this alarm is active during aeromedical transport the user should ventilate using pressure targeting if the ventilator cannot be replaced. Users should also monitor chest rise and breath sounds to ensure adequate ventilation.

Mitigation/Info: Sensor: Barometer, Altitude Compensation Disabled, Maintain Airway Pressure, Check Patient Chest Rise, Avoid Use At Varying Altitude, **Contact Service Center**

3131 Excessive Altitude

Alarm triggers when the ambient pressure transducer detects an altitude >25,000 feet (7620 meters). Beyond this altitude compensation remains fixed at the 25,000 ft compensation level. The user should monitor the airway pressure and reduce the tidal volume as altitude increases though, there is very little change in performance over this altitude. Where possible cabin pressure should be maintained in the compensated range.

Mitigation/Info: Beyond Altitude Compensation Limit, Maintain Airway Pressure, Check Patient Chest Rise, Monitor Ventilator/Patient,**Reduce Altitude/ Pre ssurize Ca bin if Possibl e**

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ZOLL EMV+, AEV, Eagle II User manual

Specifications and Main Features

Frequently Asked Questions

User Manual