731 Series Ventilator Operators Guide Rev E March 2020

The issue date for the ZOLL Ventilator Operator’s Guide (REF 9650-002363-05 Rev E) is March, 2020. Copyright © 2020 ZOLL Medical Corporation. All rights reserved. ZOLL and Smart Help are trademarks and/ or registered trademarks of ZOLL Medical Corporation in the United States and/or other countries. All other trademarks are the property of their respective owners.

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

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

Contents

Chapter 1

General Information

Product Description ... 1-1 How to Use this Guide ... 1-1 Operator’s Guide Updates ... 1-2 Unpacking... 1-2 Assembly ... 1-2 Product Symbols... 1-2 Symbols on the Ventilator Graphical User Interface ... 1-5 Conventions ... 1-7 Abbreviations ... 1-8 Indications for Use ... 1-9 Ventilation ... 1-9 Pulse Oximetry (SpO2) ... 1-9 Features ... 1-9 Warnings... 1-10 General ... 1-10 Ventilator ... 1-10 Pulse Oximeter ... 1-11 Batteries ... 1-12 User Safety ... 1-12 Patient Safety ... 1-12 MR Conditional Equipment ... 1-13 Cautions ... 1-14 FDA Tracking Requirements ... 1-14 Notification of Adverse Events ... 1-15 Software License ... 1-15 NO IMPLIED LICENSE ... 1-15 Limited Warranty ... 1-15 Technical Support ... 1-16 Returning a Ventilator for ZOLL Service ... 1-17

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Chapter 2

Product Overview

Ventilator Models ... 2-1 Operating Mode Support ... 2-2 Manual Breath and Pressure Plateau Feature ... 2-2 Ventilator Description ... 2-3 Main Features ... 2-3 Controls and Indicators ... 2-4 Controls ... 2-4 Indicators ... 2-5 Display Screen ... 2-5 Message Area ... 2-6 Parameter Windows ... 2-6 Shared Icon Area ... 2-6 Auxiliary Parameter Boxes ... 2-6 Fresh Gas/Emergency Air Intake and Attachments ... 2-7 Oxygen Reservoir Kit (Optional) ... 2-7 Top Panel ... 2-8 Pulse Oximeter Compatibility ... 2-9 Power Sources ... 2-9 Operating Using External DC Power ... 2-9 Operating Using Battery Power ... 2-9 Pneumatic Design ... 2-10 Oxygen Input: High Pressure Gas Supply ... 2-11 High Pressure Oxygen Supply Hose ... 2-11 Patient Circuits... 2-13 Intended Use ... 2-14 Use of Heat and Moisture Exchangers ... 2-14 Attaching a Patient Circuit to the Ventilator ... 2-15 Specifications ... 2-16 Pediatric/Adult, 6 ft Patient Circuit ... 2-16 Pediatric/Adult, 12 ft Patient Circuit ... 2-16 Infant/Pediatric, 6 ft Patient Circuit ... 2-16 Infant/Pediatric, 12 ft Patient Circuit ... 2-17 Reusable Circuit ... 2-17

Chapter 3

Setting Up the Ventilator

1. Attach the Patient Circuit ... 3-2 2. Attach the High Pressure Oxygen Supply (Optional) ... 3-3 3. Inspect Fresh Gas/Emergency Air Intake Filters ... 3-3 4. Connect Fresh Gas/Emergency Air Intake Attachments (Optional) ... 3-4 Oxygen Reservoir Kit ... 3-4 Bacterial/Viral (BV) Filter ... 3-5 Chemical/Biological C2A1 Filter ... 3-5 5. Select the Ventilator’s Power Source... 3-6 Connecting the Power Supply ... 3-7 6. Turn On the Ventilator... 3-8 7. Select Start Menu Option... 3-8

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8. Change Operating Mode (Optional)... 3-9 9. Change Parameter Values... 3-10 10. Perform Operational Test ... 3-10 11. Attach the Pulse Oximeter (Optional)... 3-11 12. Attach Patient... 3-12

Chapter 4

Using the Ventilator

Operating Mode Availability ... 4-2 Initial Operation with Default Parameter Settings ... 4-3 Default Parameter Settings for Adult, Pediatric and Mask CPAP ... 4-3 Adult Default Parameter Setting Values ... 4-3 Making a Choice From the Start Menu ... 4-4 Changing Parameter Settings... 4-5 Navigating the Parameter Windows Using Parameter Buttons ... 4-6 Changing a Parameter Setting ... 4-7 Example 1 - Changing a Primary Parameter ... 4-7 Example 2 - Changing a Secondary Parameter ... 4-7 Example 3- Changing a Context Menu Parameter ... 4-7 Saving Changed Parameters for Future Use... 4-8 Using the Last Settings Enabled on the Ventilator... 4-8 Mode Parameter Window Options ... 4-9 Primary Parameter ... 4-9 Secondary Parameters and Alarm Thresholds/Limits ... 4-9 Breath Target ... 4-9 Leak Compensation ... 4-10 Context Menu ... 4-10 Mode Parameter Window Reference ... 4-11 BPM Parameter Window Options ... 4-12 Secondary Parameters and Alarm Thresholds/Limits ... 4-12 Context Menu ... 4-12 Control Parameter (I:E or Ti) ... 4-13 Rise Time ... 4-13 Cycle Off % Parameter ... 4-14 Spont Ti Limit Parameter ... 4-14 BPM Parameter Window Reference ... 4-15 Vt Parameter Window Options ... 4-16 Secondary Parameters and Alarm Thresholds/Limits ... 4-16 Context Menu ... 4-17 Vt Parameter Window Reference ... 4-18 PIP Parameter Window Options ... 4-18 Secondary Parameters and Alarm Thresholds/Limits ... 4-18 Context Menu ... 4-19 PIP Parameter Window Reference ... 4-20 FIO2 Parameter Window Options ... 4-21 Secondary Parameters and Alarm Thresholds/Limits ... 4-21 Context Menu ... 4-21 FIO2 Parameter Window Reference ... 4-22

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SpO2 Parameter Window Options ... 4-22 Secondary Parameters and Alarm Thresholds/Limits ... 4-23 Context Menu ... 4-23 SpO2 Parameter Window Reference ... 4-24 HR (Heart Rate) ... 4-25 Secondary Parameters and Alarm Thresholds/Limits ... 4-25 Context Menu ... 4-25 HR Parameter Window Reference ... 4-26 Manual Breath ... 4-27 Plateau Pressure ... 4-27 Plateau Pressure Maneuver ... 4-27 Popup Messages ... 4-28 Popup Message List ... 4-29 Transitions ... 4-36 Using the Menu... 4-37 Alarm Configuration ... 4-37 Powerup ... 4-37 Specifying Powerup Settings ... 4-38 Specifying Custom Settings ... 4-38 Specifying a Language ... 4-38 LCD Contrast ... 4-38 LCD Brightness ... 4-39 UTC Offset ... 4-39 Unit Info ... 4-40 Alarm History ... 4-40

Chapter 5

Alarms

Alarm Overview ... 5-1 Muting Alarms ... 5-3 Alarm Priorities ... 5-3 High Priority ... 5-3 Medium Priority ... 5-3 Low Priority (Advisory) ... 5-3 Popup Messages ... 5-4 Alarm Types ... 5-4 Patient Safety Alarm Type ... 5-4 Environmental and Use Alarm Types ... 5-7 Complete Power Failure ... 5-9 Self-Check Alarm Types ... 5-9 Managing Alarms ... 5-11 Alarm Muting ... 5-12 Start Up Muting ... 5-12 Preemptive Muting ... 5-12 Disabling Alarms from the Alarm Configuration Menu ... 5-14 Patient Detect Mode ... 5-14 Backup Modes ... 5-15 Apnea Backup Mode ... 5-15

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Alarm Summary ... 5-16 High Priority Alarms ... 5-16 Medium Priority Alarms ... 5-22 Low Priority Alarms ... 5-31

Chapter 6

Operating Environments

Using the Ventilator in Transport Environments... 6-1 Using the Ventilator in Harsh Environments ... 6-1 Airborne Particulates ... 6-2 Extreme Temperature Environments ... 6-2 Operating at High Temperatures ... 6-2 Operating at Low Temperatures ... 6-2 Altitude ... 6-3 Rain and Snow ... 6-3 Using the Ventilator in Hazardous Environments ... 6-4 Bacterial/Viral Filter Use ... 6-4 Chemical/Biological Filter Use ... 6-4 Check Valve on Patient Circuit when in Hazardous Environments ... 6-5 Using the Ventilator in an MRI Environment ... 6-6

Chapter 7

Maintenance

Inspecting the Ventilator ... 7-1 Cleaning... 7-2 Post-Contaminated Environment Cleaning ... 7-2 Fresh Gas/Emergency Air Intake Filters ... 7-3 Inspecting and Replacing the Foam Filter ... 7-3 Inspecting and Replacing the Disk Filter ... 7-3 Replacing Ventilator Filters ... 7-4 Replacing the Foam Filter ... 7-4 Replacing the Disk Filter ... 7-4 Battery Maintenance ... 7-5 Battery Storage ... 7-7 Ventilator Storage ... 7-7 Battery Replacement and Shipping Regulations ... 7-8 Calibration Checks... 7-8 Pulse Oximeter Check ... 7-8 Electrical Safety Check ... 7-8 Troubleshooting ... 7-9

Appendix A

Specifications

General ...A-1 Pulse Oximeter ...A-3 Device Classification...A-4 Emissions and Immunity Compliance ...A-5 Electromagnetic Immunity ...A-6 Basic Safety and Essential Performance...A-7 9650-002363-05 Rev E

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Appendix B Accessories Appendix C Pulse Oximeter Principles Pulse Oximeter Signaling ...C-1 Successful Monitoring for SpO2, PR and Pi ...C-2 Functional Oxygen Saturation (SpO2) ...C-2 Pulse Oximeter Operation ...C-2 Understanding Alarm Response Delay ...C-3

Appendix D Troubleshooting Patient Circuits Troubleshooting Procedure...D-1

Index

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Chapter 1 General Information This chapter provides general information about the ZOLL ventilators and the ZOLL Ventilator Operator’s Guide, which we provide with this product. Specifically, this chapter provides: A brief description of the ventilator. Information about this manual (ZOLL Ventilator Operator’s Guide). A table that describes the symbols that appear on a ventilator and in this manual. Ventilator Indications for Use. A list of Warnings and Cautions regarding the use of ZOLL ventilators. 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 ZOLL ventilators are small, extremely durable, full-featured portable mechanical ventilator designed to operate in hospitals or severe and under-resourced environments. They can be used in prehospital, aeromedical, field hospital and hospital settings.

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

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Chapter 1 General Information

Operator’s Guide Updates An issue or revision date for this manual is shown on the front cover. If more than 3 years have elapsed since this date, contact ZOLL Medical Corporation to determine if additional product information updates are available. All users should carefully review each manual update to understand its significance and then file it in its appropriate section within this manual for subsequent reference. Product documentation is available through the ZOLL web site 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 device has been checked for mechanical and electrical integrity. If the contents are incomplete, if there is mechanical damage, or if the ventilator does not pass its Self-Check test when turned on, U.S.A. customers should call ZOLL Medical Corporation (1-978-421-9655). Customers outside of the U.S.A. should contact the nearest ZOLL authorized representative. If the shipping container is damaged, also notify the carrier. If there is no apparent sign of mechanical damage, read instructions contained within this manual before attempting operation.

Assembly The device only requires that you attach the breathing circuit to begin ventilation using either battery or external power. Both the ventilator and breathing circuit are supplied clean and are ready for use on a patient.

Product Symbols The following symbols appear on a ventilator or in this manual: Symbol

Description Off

On

Direct Current: Identifies the location to connect external DC Power.

Mute / Cancel: Identifies button which mutes the active alarms or cancels the parameter selection.

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Symbol

Description Accept /Select: 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 identifies the name and address of the manufacturer.

Manufacturer Date: Manufacturer Date Symbol identifies the device’s date of manufacture.

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Symbol

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

Refer to instruction manual.

Menu icon. This icon identifies the button that, when pressed, displays a menu of options that you can select to configure the ventilator.

280 - 600 kPa High Pressure O2 Connector (top faceplate icon). O2 (40 - 87 PSIG) Maximum Operational Flow Rate: 100 l/m (liters per minute).

HAUST NOT OCC

Exhalation Valve (top faceplate icon).

Exhaust Do Not Occlude (top faceplate icon).

Transducer (top faceplate icon).

Gas Output -- Patient Circuit Connector (top faceplate icon).

Contains Phthalates

Non-Sterile

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Symbols on the Ventilator Graphical User Interface 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 Outline: Identifies alarm limit settings; Identifies the on-screen alarms.

Alarm Bell: Identifies the number of off-screen alarms.

+

O2 reservoir mode is in use.

LC

Leak Compensation (LC) feature is ON.

LC

Leak Compensation Feature is OFF.

___

Patient Detect Mode: Backup Ventilation Started.

__

Not receiving a reading from the pulse oximeter.

Warning: High Priority Alarm Active.

Caution: Medium Priority Alarm Active.

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Symbol

Description Attention: Low Priority Alarm Active.

Mute: Active Alarm Audible Signal Muted.

Speaker: Active Alarm Audible Signal.

Oxygen Supply: Oxygen Supply Connected.

External Power: Indicates the device is operating using an external power source.

No External Power: Indicates the device is operating without an external power source.

Internal Battery: Provides indication of battery capacity and charging.

EXT BATT

Indicates that an external battery is powering the ventilator.

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

Head with Mask: the device is in the non-invasive positive pressure ventilation modes, CPAP or BL, with Leak Compensation turned on.

off on

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Feature OFF -- feature or alarm not selected.

Feature ON -- feature or alarm has been selected.

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Symbol

Description

srch

Search (Pulse oximeter searching for a patient signal.)

stby

Standby (Pulse oximeter in standby.).

Conventions This guide uses the following conventions: • Within text, the names and labels for physical buttons and soft-keys appear in boldface type

(for example, “Press the Accept button”). • Within text, system and alarm messages which display on the screen appear with initial

capitalization.(for example, External Power Failure).

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 device.

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Chapter 1 General Information

Abbreviations A/C - Assist/Control

ID - Internal Diameter

AEV - Automatic Electrical Ventilator

IPAP - Inspiratory Positive Airway Pressure.

ACLS - Advanced Cardiac Life Support

L - Liters

ALS - Advanced Life Support

LC - Leak Compensation

ATLS - Advanced Trauma Life Support

LCD - Liquid Crystal Display

ACV - Assist-Control Ventilation

LED - Light Emitting Diode

AMC - Alarm Message Center

LPM - Liters Per Minute

APOD - Advanced Probe Off Detection

ml - Milliliters

ATPD - Ambient Temperature and Pressure Dry

mm - Millimeter

b/min - Beats Per Minute

MRI - Magnetic Resonance Imaging

B/V - Bacterial/Viral Filter

O2 - Oxygen

BL - Bilevel positive airway pressure

Paw - Airway Pressure

BPM - Breaths per Minute

PEEP - Positive End Expiratory Pressure

cm H2O - Centimeters of Water

PIP - Peak Inspiratory Pressure

CPAP - Continuous Positive Airway Pressure

PPV - Positive-Pressure Ventilation

CPR - Cardiopulmonary Resuscitation

PS - Pressure Support

CPU- Central Processor Unit

psig - Pounds per Square Inch Gage

CT - Tubing Compliance

RF - Radio Frequency

dBA - Decibel

RGA # - Returned-Goods-Authorization number

DISS - Diameter Index Safety System

RTC - Real Time Clock

EMC - Electromagnetic Compatibility

SIMV - Synchronized Intermittent Mandatory Ventilation

EMV - Emergency Medical Ventilator

SPM - Smart Pneumatic Module

EPAP - Expiratory Positive Airway Pressure

SpO2 - Oxyhemoglobin Saturation,%

ESD - Electrostatic Discharge

USP - United States Pharmacopoeia

FIO2 - Fraction of Inspired Oxygen

VAC - Volts AC

HME - Heat and Moisture Exchanger

VDC - Volts DC

HMEF - Heat and Moisture Exchanger/Bacterial Viral filter combined

VT - Tidal Volume

hPa - Hectopascal

WOB – Work Of Breathing

HP O2 - High Pressure Oxygen Hz - Hertz (as in frequency, cycles per second) I:E- Inspiratory/Expiratory Ratio

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Indications for Use Ventilation The ZOLL ventilator is indicated for use in the management of infant through adult patients weighing ≥ 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. ZOLL ventilators are appropriate for use in hospitals, outside the hospital, during transport and in severe environments where they may be exposed to rain, dust, rough handling, and extremes in temperature and humidity. With an appropriate third-party filter in place, they may be operated in environments where chemical and/or biological toxins are present. When marked with an “MRI conditional” label, the ZOLL ventilators are suitable for use in an MRI environment with appropriate precautions. ZOLL ventilators are intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation, and by first responders under the direction of skilled medical care providers.

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

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 user interface minimizes user training and protects existing settings from

inadvertent contact and manipulation. • Smart Help™ messages guide the user through on-screen commands when responding to • • • • • • • •

alarms. Lightweight < 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: -26 to 55 °C. Altitude compensation from 110 to 37.6 kPa (-2,250 to 25,000 ft). Self-contained system able to operate with or without external oxygen. Gas manifold design allows operation with both high and low-pressure oxygen sources. All oxygen is delivered to the patient breathing circuit. Sealed gas path with chemical/biological filter connected to assure safe breathing gas supply. Case and control panel protects components from weather and fluids.

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Warnings General • ZOLL ventilators are intended for use by qualified personnel only. You should read this • • • •

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

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

When using external power, position the power cord to avoid accidental disconnect. • The use of accessories and cables other than those sold by ZOLL may result in increased •

•

• • •

•

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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 Appendix A Specifications of this guide. ZOLL ventilators 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 Oximeter) that are specified by ZOLL. Grounding: • Do not under any circumstances remove the grounding conductor from the power plug. • Do not use extension cords or adapters of any type. The power cord and plug must be intact and undamaged. • If there is any doubt about the integrity of the protective earth conductor or power supply, operate on internal battery power. As with all medical equipment, carefully route the patient circuit, patient cabling, and external power cords to reduce the possibility of patient entanglement or strangulation. The product design includes materials with phthalates in the pressure lines of both the manifold design and patient circuit. Patient mask accessories used with the device also are made with materials containing phthalates. Phthalates are NOT present in the inspiratory line (blue hose/tube) of the patient circuit.

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Chapter 1 General Information • Do not use in MRI environment unless MRI marking is present. • Do not operate the ventilator on a patient when the USB port is connected to any other

device (the USB port is only for servicing the ventilator). • The ZOLL-supplied patient circuit’s labeling provides the resistance and compliance values

for the circuits under normal operating conditions. If added accessories are used (e.g. HME, filters etc.), you should assure they do not degrade the performance of the device.

Pulse Oximeter • Do not use the pulse oximeter as an apnea monitor. • A pulse oximeter should be considered an early warning device. As a trend towards patient

•

•

• •

deoxygenation is indicated, blood samples should be analyzed by a laboratory co-oximeter to completely understand the patient’s condition. Measurements: if the accuracy of any measurement does not seem reasonable, first check the patient’s vital signs by alternate means and then check the pulse oximeter for proper functioning. Inaccurate measurements may be caused by: • Incorrect sensor application or use. • Significant levels of dysfunctional hemoglobin (e.g. carboxyhemoglobin or methemoglobin). • Intra-vascular dyes such as indocyanine green or methylene blue. • Exposure to excessive illumination, such as surgical lamps (especially ones with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, or direct sunlight (exposure to excessive illumination can be corrected by covering the sensor with a dark or opaque material). • Excessive patient movement. • Venous pulsations. • Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line. • The pulse oximeter is defibrillator-proof. The pulse oximeter can be used during defibrillation, but the readings may be inaccurate for a short time. Interfering Substances: carboxyhemoglobin may erroneously increase readings. The level of increase is approximately equal to the amount of carboxyhemoglobin present. Dyes, or any substance containing dyes, that change usual arterial pigmentation may cause erroneous readings. Alarms: Check alarm limits each time the pulse oximeter is used to ensure that they are appropriate for the patient being monitored. Loss of pulse signal can occur in any of the following situations: • The sensor is too tight. • Excessive illumination from light sources such as a surgical lamp, a bilirubin lamp, or sunlight. • A blood pressure cuff is inflated on the same extremity as the one with an SpO2 sensor attached. • The patient has hypotension, severe vascoconstriction, severe anemia, or hypothermia. • Arterial occlusion proximal to the sensor. • The patient is in cardiac arrest or is in shock.

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Chapter 1 General Information • Sensors:

Before use, carefully read the Masimo LNCS® sensor directions for use. Use only Masimo oximetry sensors for SpO2 measurements. Other oxygen transducers (sensors) may cause improper performance. • Tissue damage can be caused by incorrect application or use of an LNCS sensor for example, by wrapping the sensor too tightly. Inspect the sensor site as directed in the sensor Directions for Use to ensure skin integrity and correct positioning and adhesion of the sensor. When operating at extreme temperatures, take care not to apply the sensor with excessive pressure and monitor application to prevent tissue damage. • Do not damage LNCS sensors. Do not use an LNCS sensor with exposed optical components. Do not immerse the sensor in water, solvents, or cleaning solutions (The sensors and connectors are not waterproof). Do not sterilize by irradiation, steam, or ethylene oxide. See the cleaning instructions in the directions for reusable Masimo LNCS sensors. • Do not use damaged patient cables. Do not immerse the patient cables in water, solvents, or cleaning solutions (the patient cables are not waterproof). Do not sterilize by irradiation, steam, or ethylene oxide. See the cleaning instructions in the directions for reusable Masimo patient cables. • Do not use the pulse oximeter sensor during magnetic resonance imaging (MRI) scanning. Inducing current could potentially cause burns. The pulse oximeter may affect the MRI image and the MRI unit may affect the accuracy of the dosimetry measurements. • •

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

cause damage or create a fire and/or destroy the battery and device. • If you witness a battery or the battery compartment starting to balloon, swell up, smoke, or

feel excessively hot, turn off the device, disconnect external power, and observe it in a safe place for approximately 15 minutes and send the device for service. Never puncture or disassemble the battery packs or cells.

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

•

• • • • •

maintenance procedures specifically described in this manual. Refer all servicing to ZOLL or a ZOLL-authorized service center. Possible explosion hazard if used in the presence of flammable anesthetics or other flammable substances in combination with air, oxygen-enriched environments, or nitrous oxide. This device is not intended for use in explosive atmospheres. Pins of connectors identified with the ESD warning symbol should not be touched. Always use precautionary procedures with ESD-sensitive connections. Power source installation must only be carried out by qualified service personnel Verify integrity of the external power source Connect and verify that the fixed equipment is connected to the power source

Patient Safety • To ensure patient electrical isolation, connect only to other equipment with electronically

isolated circuits. • Do not place the device or external power supply in any position that might cause it to fall

on the patient. Do not lift the device by the power cord, patient circuit, or pulse oximeter patient cable. • Never service the ventilator while in use with a patient.

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