Zoll AED Pro User manual

and

Operator’s Guide

9650-0350-01 Rev. GJune 2009

An issue date and revision level for this guide appear on the title page. If more than three years have elapsed since this date, contact ZOLL Medical Corporation to determine if

additional product information updates are available. ZOLL, AED Pro, AED Plus, CPR-D•padz, stat•padz, pedi•padz, RescueNet, Real CPR Help,

See-Thru CPR, “Advancing Resuscitation. Today.” and M Series are registered trademarks of ZOLL Medical Corporation. PowerCharger, Rectilinear Biphasic, and SurePower are trademarks of ZOLL Medical Corporation. All other trademarks and registered trademarks are property of their respective owners.

Table of Contents

Ch a p t e r 1 Product Overview

Defibrillation........................................................................................................................ 1-2

Defibrillation Modes ....................................................................................................1-2

Semiautomatic Mode Defibrillation and CPR Monitoring....................................................1-2

Manual Mode Defibrillation.................................................................................................1-3

ECG Monitoring..................................................................................................................1-3

Audio Recording.................................................................................................................1-4

Nonrescue Mode ................................................................................................................1-5

Data Transfer ..............................................................................................................1-5

Device Configuration ..................................................................................................1-5

Standby State......................................................................................................................1-5

Automatic Shutoff................................................................................................................1-5

Accessories ........................................................................................................................1-6

A-W Accessories ........................................................................................................1-7

The Front Panel..................................................................................................................1-8

Display Screen ..........................................................................................................1-10

Chapter 2 Getting Started

Installing a Battery Pack.....................................................................................................2-2

CHANGE BATTERY Warning ....................................................................................2-4

Preparing the Unit for Clinical Use......................................................................................2-5

Performing a Self-Test ........................................................................................................2-6

Automatic Self-Tests ...................................................................................................2-6

Manual Self-Test .........................................................................................................2-6

Preconnecting the Defibrillation Electrodes Cable..............................................................2-7

Messages ...........................................................................................................................2-8

Ch a p t e r 3 Semiautomatic Mode

Applying Defibrillation Electrode Pads................................................................................3-2

Applying Defibrillation Electrode Pads — Adult CPR-D•padz .....................................3-3

Applying Defibrillation Electrode Pads — Adult CPR stat•padz ................................. 3-5

CPR Monitoring with CPR-D•padz and CPR stat•padz ..............................................3-6

Applying Defibrillation Electrode Pads — Adult stat•padz II .......................................3-7

Applying Defibrillation Electrode Pads — Infant/Child pedi•padzII ............................3-8

Semiautomatic Defibrillation ...............................................................................................3-9

Start with CPR Option ...............................................................................................3-12

Messages in Semiautomatic Mode ...........................................................................3-12

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TABLE OF CONTENTS

Ch a p t e r 4 Manual Mode

About Manual Mode............................................................................................................4-2

Switching to Manual Mode..................................................................................................4-3

Manual Defibrillation ...........................................................................................................4-4

See-Thru CPR....................................................................................................................4-5

Messages in Manual Mode...............................................................................................4-10

Chapter 5 ECG Monitoring Mode

About ECG Monitoring........................................................................................................5-2

ECG Electrode Placement..................................................................................................5-3

Applying ECG Electrodes...................................................................................................5-4

Monitoring the ECG Rhythm...............................................................................................5-6

Monitoring with ECG Electrodes .................................................................................5-6

Monitoring with Defibrillation Electrodes .....................................................................5-7

Messages in ECG Monitoring Mode...................................................................................5-8

Ch a p t e r 6 Nonrescue Mode

Entering Nonrescue Mode..................................................................................................6-2

Data Storage.......................................................................................................................6-3

Device History .............................................................................................................6-3

Patient Clinical Data ...................................................................................................6-3

Communicating with an External Device............................................................................6-4

Setting Up Data Communications with an IrDA Connection .......................................6-4

Downloading Data to a USB Device ...........................................................................6-4

Setting the Date and Time..................................................................................................6-5

Device Configuration ..........................................................................................................6-6

ZOLL Administration Software............................................................................................6-6

Installing ZOLL Administration Software .....................................................................6-6

RescueNet Code Review Software ............................................................................6-7

Messages in Nonrescue Mode...........................................................................................6-8

Chapter 7 Troubleshooting and Maintenance

General Troubleshooting....................................................................................................7-2

ECG Monitoring Troubleshooting........................................................................................7-4

Defibrillator Troubleshooting...............................................................................................7-5

Cleaning the Unit................................................................................................................7-6

Optional Maintenance for Technical Professionals.............................................................7-7

Ap p e n d i x A Specifications

Device Specifications..........................................................................................................A-2

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Battery Pack Specifications................................................................................................A-5

Guidance and Manufacturer’s Declaration — Electromagnetic Emissions.........................A-6

Electromagnetic Immunity Declaration (EID) ..............................................................A-7

Rectilinear Biphasic Waveform Characteristics................................................................A-10

Clinical Trial Results for the M Series Biphasic Waveform...............................................A-13

Randomized Multicenter Clinical Trial for Defibrillation of Ventricular Fibrillation

(VF) and Ventricular Tachycardia (VT) ...................................................................A-13

ECG Analysis Algorithm Accuracy....................................................................................A-15

Ap p e n d i x B Rechargeable Battery Packs

Managing Rechargeable Battery Packs .............................................................................B-2

Recharging and Testing Battery Packs...............................................................................B-2

Achieving Optimal Performance with Rechargeable Batteries...........................................B-3

Ap p e n d i x C Configurable Settings

Descriptions of AED Pro Configurable Settings..................................................................C-2

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TABLE OF CONTENTS

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Preface

The AED Pro® and AED Pro® A-W from ZOLL Medical Corporation is a portable, automated external defibrillator (AED) intended for use by trained rescuers to provide emergency defibrillation and to monitor patient ECG during treatment.

This Preface contains the following sections:

• “How To Use This Guide” on page vi

• “Safety Considerations” on page vii

• “Equipment” on page xi

• “Intended Use” on page xvi

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide v

PREFACE

How To Use This Guide

The AED Pro Operator’s Guide provides information that operators need for the safe and effective use and care of the AED Pro device. Before operating this device, be sure to read and understand all the information contained within.

This guide also describes device setup and maintenance procedures. Separate chapters in this document describe use of the device in either semiautomatic or

manual mode.

Manual Updates

ZOLL Medical Corporation provides manual updates to inform customers of changes in device information and use. Customers should carefully review each update to understand its significance, and then file the u pdate in its appropriat e section within the manual for subsequent reference.

Product documentation is available through the ZOLL website at www.zoll.com. From the Products menu, choose Product Documentation.

Related Manuals

In addition to this manual, the following ZOLL publications provide information about this product and related products and accessories:

REF Title

9650-0054-01 9650-0120-01 9651-0801-01 AED Pro Simulator Operator’s Guide

9650-0535-01 SurePower™ Charger Station Operator’s Guide 9650-0536-01 SurePower Battery Pack Guide

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 Shock button or the DISARM softkey”). This guide uses uppercase italics for audible prompts and for text messages displayed on the

screen (for example, DON’T TOUCH PATIENT, ANALYZING).

ZOLL Base PowerCharger ZOLL Base PowerCharger

4x4

Operator’s Manual

1x1

Operator’s Manual

WARNING! Warni ng stat ements aler t yo u to cond itions o r ac tions 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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Safety Considerations

All operators should review these safety considerations before placing the AED Pro unit into service.

These operating instructions describe the functions and proper operation of the AED Pro unit. This manual does not substitute for a formal training course. Operators must obtain formal training from an appropriate authority before using this device for patient care.

Follow all recommended maintenance instructions. If a problem occurs, obtain service immediately. Do not use the device until it has been inspected by appropriate personnel.

Do not disassemble the unit. A shock hazard exists. Refer all problems to authorized service personnel.

The AED Pro unit is capable of delivering 200 jou les. To completely deactivate the unit, turn it off and remove the battery pack.

To manually disarm a charged (or charging) defibrillator, do one of the following:

• Turn the unit off for at least 3 seconds.

• Press the DISARM softkey (manual mode only).

For safety, the AED Pro unit automatically disarms a fully charged defibrillator after 60 seconds in manual mode or 30 seconds in semiautomatic mode if the Shock button is not pressed.

Safety Considerations

General

Federal (U.S.A.) law restricts this device to use by or on the order of a physician. Proper operation of the unit and correct electrode placement are critical to obtaining optimal

results. Operators must be thoroughly familiar with proper device operation. The use of external defibrillation electrodes or adapter devices from sources other than ZOLL

is not recommended. ZOLL Medical Corporation makes no representations or warranties regarding the performance or effectiveness of its products when used with defibrillation electrodes or adapter devices from other sources. Device failures attributable to the use of defibrillation electrodes or adapters not manufactured by ZOLL might void the warranty on the ZOLL equipment.

This device is protected against interference from radio frequency emissions typical of the two-way radios and cellular phones (digital and analog) used in emergency service or public safety activities. You should assess the device’s performance in your typical operating environment to determine the like lihood of radio frequency interference (RFI) from high-power sources. Radio frequency interference can cause shifts in the monitor baseline, trace compression, changes to brightness of the display, or transient spikes on the screen.

The AED Pro unit might not perform to specifications when stored at the upper or lower extreme limits of storage temperature and then immediately put into use.

Do not use or stack the unit with other equipment. If the unit is used or stacked with other electrical equipment, verify proper operation before using it.

Do not use or place the unit in service if it beeps while turned off. The use of accessories or cables other than those specified in this manual may result in

increased emissions or decreased immunity of the AED Pro.

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide vii

PREFACE

Do not use or place the unit in service if the Ready indicator (at the upper righ t of the front panel) shows a red “X”.

Defibrillation

Emergency defibrillation should be performed only by appropriately trained, skilled personnel who are familiar with the operation of the equipment. The prescribing physician should determine what training, such as Advanced Cardiac Life Support (ACLS) or Basic Life Support (BLS) certification, is appropriate for operating this device.

ECG analysis

A patient must be motionless during ECG analysis. Do not touch the patient during analysis. Cease all patient movement by stretcher or vehicle before beginning ECG analysis in semiautomatic mode.

Cardiopulmonary resuscitation (CPR)

Before performing CPR, place the patient on a firm surface.

Battery care

Keep a fully charged spare battery pack with the device at all times. When the unit displays the message CHANGE BATTERY, immediately replace the battery pack

with a fully charged one. Regular use of a partially charged battery pack without fully recharging it between uses might

permanently reduce the battery’s capacity and result in early failure. Regularly test rechargeable battery packs. A rechargeable battery pack that does not pass its test

could fail without warning. Do not disassemble a battery pack or dispose of it in fire. Do not try to recharge a

nonrechargeable battery pack. If mistreated, a battery pack might explode. Dispose of battery packs in accordance with federal, state, and local regulations. Battery packs

should be shipped to a reclamation facility for recovery of metal and plastic compounds as the proper method of waste management.

Operator Safety

Do not use the unit near oxygen-rich atmospheres, flammable anesthetics, or other flammable agents (such as gasoline).

Do not use the unit within standing water. Before discharging the defibrillator, warn everyone to stand clear of the patient. Do not discharge the defibrillator except as indicated in the instructions. Discharge the

defibrillator only when defibrillation pads are properly attached to the patient. Never discharge the unit with the defibrillation pads shorted together or in open air.

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Safety Considerations

Electrical shock

Before defibrillation, be sure to disconne ct from the patient all el ectromedical equi pment that is not defibrillation-protected. Keep defibrillation electrodes away from all other equipment attached to the patient and from metal objects in contact with the patient.

During defibrillation, do not touch the bed, the patient, conductive material, or any equipment connected to the patient; a severe shock can result. To avoid hazardous pathways for the defibrillation current, do not allow exposed portions of the patient’s body to touch any metal objects, such as a bed frame.

Accessory equipment

The use of accessory equipment that does not comply with the equivalent safety requirements of the AED Pro device could reduce the level of safety of the resulting system. When selecting accessory equipment, consider the following:

• Use of the accessory in the patient vicinity

• Evidence that the safety certification of the accessory has been performed in accordance

with the appropriate IEC (EN) 60601-1 and/or IEC (EN) 60601-1-1 harmonized national standards.

Patient Safety

The AED Pro unit detects ECG electrical signals only and does not detect a pulse (effective circulatory perfusion). Always verify pulse and heart rate by physical assessment of the patient. Never assume that the display of a nonzero heart rate means that the pat ient has a pulse.

ECG rhythm analysis does not warn of patient asystole, which is not a shockable rhythm. Do not connect the AED Pro to a PC or other device (via the USB port) while the unit’s

electrodes are still connected to the patient. Check electrical leakage levels before use. Leakage current might be excessive if more than one

monitor or other piece of equipment is connected to the patient. Do not use this equipment in the presence of electrosurgery.

Defibrillation pads and ECG electrodes

Check the expiration date on the electrode packaging. Do not use electrodes that have passed their expiration date.

Do not use defibrillation pads or ECG electrodes if the gel is dried or damaged; patient burns or poor quality ECG signals might result from using such electrodes.

Poor adherence or air pockets under defibrillation pads can cause arcing, skin burns, or reduced energy delivery . To minimize burning, apply freshly opened and undamaged defibrillation pads to clean and dry skin. Excessive body hair or wet, diaphoretic skin can inhibit electrode pad coupling (contact) with the skin. Clip excess hair and dry any moisture from the area where an electrode pad is to be attached.

To prepare for an emergency, keep the defibrillation electrode cable connected to the unit at all times, even when the unit is not in use.

Use only high-quality ECG electrodes. ECG electrodes are for mo nitoring only; you cannot use ECG electrodes for defibrillation.

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide ix

PREFACE

Implanted pacemakers

Do not place electrodes directly over an implanted pacemaker. Implanted pacemakers might cause the heart rate meter or ECG rhythm analysis to count the pacemaker rate during incidents of cardiac arrest or other arrhythmia. Carefully observe pacemaker patients. Check the patient’s pulse; do not rely solely on heart rate meters. Patient history and physical examination are important factors in determining the presence of an implanted pacemaker.

Cautions

Do not sterilize the device or the ECG monitoring cable. Do not immerse any part of the device into water. Do not use ketones (such as MEK or acetone) on the device. Avoid using abrasives (including paper towels) on the display screen and IrDA port.

Restarting the Device

Certain events require a restart of the AED Pro unit after it shuts off, encounters an error, or becomes inoperative. If such an event occurs, always try to restore device operatio n as follow s before seeking alternative methods of patient monitoring or treatment:

1. Press and hold the On/Off button for 1 second to turn the unit off.

2. After the unit has shut down, wait at least 3 seconds.

3. Press and release the On/Off button to restart the unit.

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Equipment

Before unpacking the AED Pro unit, carefully inspect each shipping container for damage. If the container or cushioning material is damaged, keep it until you have checked the contents for completeness, and the unit has been tested for mechanical and electrical integrity.

Examine the unit for any signs of damage that might have occurred during sh ipping. Review the shipping list to ensure that you received all ordered items. If the contents are incomplete, if there is mechanical damage, or if the device does not pass its electrical self-test (as indi cated by a red “X” in the Ready indicator after battery installation), conta ct the ZOLL Technical Service Department or the nearest ZOLL authorized representative. If the shipping container is damaged, notify the carrier also.

Symbols Used on the Equipment

The following symbols might appear in this document or on the AED Pro unit, battery packs, electrodes, or shipping materials.

Symbol Description

Equipment

Dangerous voltage.

Attention, consult accompanying documents.

Fragile, handle with care.

Keep dry.

This end up.

Temperature limitation.

Conformité Européenne Complies with medical device directive 93/42/EEC.

Defibrillator-proof type BF equipment.

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide xi

PREFACE

2%452.

,%!$

2%#9#,%

RETURN

Li-ION

RECYCLE

Li-ION

Symbol Description

Defibrillator-proof type CF equipment.

Contains lead. Recycle or dispose of properly.

Contains lithium. Recycle or dispose of properly.

Keep away from open flame and high heat.

Do not open, disassemble, or intentionally damage.

Do not crush.

Nonrechargeable battery.

Do not discard in trash. Recycle or dispose of properly.

Date of manufacture.

Use by.

Latex-free.

Do not reuse.

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Symbol Description

Do not fold.

Not sterile.

Nonionizing electromagnetic radiation.

Manufacturer.

Authorized representative in the European Community.

Equipment

Serial Number.

Catalogue number.

Consult instructions for use.

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide xiii

PREFACE

FDA Tracking Requirements

U.S. Federal Law (21 CFR 821) requires the tracking of defibrillators. Under this law, owners of this device 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. Part number, model number, and serial number of the device

3. Disposition of the device (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 01824-4105

Fax: (978) 421-0025 Tel: (978) 421-9655

Notification of Adverse Events

Under the Safe Medical Devices Act (SMDA), health care providers are responsible for reporting to ZOLL Medical Corporation, and possibly to the FDA, the occurrence of certain events.

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

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Contacting Technical Service

The AED Pro unit is calibrated at the factory, and does not require periodic recalibration or adjustment. If a unit requires service, contact the ZOLL Technical Service Department.

Telephone: 1-800-348-9011 (within the U.S.A. only)

1-978-421-9655

Fax: 1-978-421-0010

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.

Equipment

Remove the battery pack from the unit. Pack the unit with its cables in the original containers (if available) or equivalent packaging. Be sure the assigned service request number appears on each package.

For customers Return the unit to

ZOLL Medical Corporation 269 Mill Road

In the U.S.A.

In Canada

In other locations

Chelmsford, MA 01824-4105 Attention: Technical Service Department (SR number) Telephone: 1-800-348-9011 ZOLL Medical Canada Inc.

1750 Sismet Road, Unit #1 Mississauga, Ontario L4W 1R6

Attention: Technical Service Department (SR number) Telephone: 1-866-442-1011 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

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide xv

PREFACE

Intended Use

The AED Pro unit is intended to defibrillate victims of ventricular fibrillation or pulseless ventricular tachycardia, for ECG monitoring, and for CPR monitoring of patients. The CPR monitoring function provides a metronome designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a compression depth of 1.5 to 2 inches (3.8 to 5.0 cm) for adult patients.

Indications for Use

Use of the device for defibrillation is indicated on victims of cardiac arrest with apparent lack of circulation as indicated by

• Unconsciousness

• Absence of breathing, and

• Absence of pulse and other signs of circulation.

When the victim is less than 8 years old or weighs less than 55 lb. (25 kg), use ZOLL pedi•padz® II pediatric defibrillation electrodes. Do not delay therapy to determine the patient’s exact age or weight.

The device is also intended for use when ECG monitoring is indicated to evaluate the patient’s heart rate or ECG morphology.

Contraindications for Use

Defibrillation

Never use the AED Pro unit for defibrillation when the patient

• Is conscious

• Is breathing, or

• Has a detectable pulse or other sign of circulation.

CPR Monitoring

The CPR monitoring function is not intended for use on patients under 8 years of age.

Intended Users

In semiautomatic mode, the AED Pro unit is intended to be used by rescuers and emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the operator controls delivery of shocks to the patient.

In manual mode, the AED Pro unit is intended to be used only by qualified medical personnel trained in Advanced Life Support skills.

In ECG monitoring mode, the AED Pro unit is intended to be used by personnel who are qualified by training in the use of the AED Pro device, basic life and/or advanced life support, or other physician-authorized emergency medical trainin g.

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Defibrillator Precautions

Inappropriate defibrillation of a patient (for example, with no malignant arrhythmia) can precipitate ventricular fibrillation, asystole, or other dangerous types of arrhythmia.

Without proper application of electrode pads, defibrillation might be ineffective and cause burns, particularly when repeated shocks are necessary. Erythema or hyperemia of the skin under the defibrillation pads often occurs. This reddening effect, often enhanced along the perimeter of the pad, should diminish substantially within 72 hours.

Defibrillator output energy

The AED Pro unit can deliver as much as 200 joules into a 50 ohm impedance. The energy delivered through the chest wall, however, is determined by the patient’s transthoracic impedance.

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AED PRO OPERATOR’S GUIDE

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9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide xviii

Chapter 1

Product Overview

The AED Pro device provides the following clinical modes:

• Semiautomatic defibrillation with CPR monitoring

• Manual defibrillation

• ECG monitoring

To guide the operator through rescue protocols, the AED Pro unit issues instructions through text messages displayed on its screen and by voice prompts played through a speaker.

This chapter introduces the AED Pro unit, and contains the following sections:

• “Defibrillation” on page 1-2

• “Semiautomatic Mode Defibrillation and CPR Monitoring” on page 1-2

• “Manual Mode Defibrillation” on page 1-3

• “ECG Monitoring” on page 1-3

• “Audio Recording” on page 1-4

• “Nonrescue Mode” on page 1-5

• “Standby State” on page 1-5

• “Automatic Shutoff” on page 1-5

• “Accessories” on page 1-6

• “The Front Panel” on page 1-8

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide 1–1

CHAPTER 1PRODUCT OVERVIEW

Defibrillation

The AED Pro unit uses the ZOLL Rectilinear Biphasic™ waveform and ZOLL single-use defibrillation electrode pads for defibrillation.

Escalating energy levels for the first three shocks are preconfigured into the unit for adult and pediatric patients. (The unit selects the appropriat e levels by detecting the type of defibrillation electrode pads in use.) After the first three shocks, all subsequent shocks are delivered at the same energy as the third shock.

The factory default energy levels in joules are as follows:

First shock Second shock Third shock

Adult 120 150 200 Pediatric 50 70 85

For more information, refer to Appendix C, “Configurable Settings”.

Defibrillation Modes

The AED Pro unit can be manufactured to run in one of three defibrillation modes:

• Semiautomatic Mode Defibrillation with CPR Monitoring

• Manual Mode Defibrillation

• Semiautomatic Mode Defibrillation with CPR Monitoring and Manual Mode Override

Semiautomatic Mode Defibrillation and CPR Monitoring

When the AED Pro unit is configured to run in semiautomatic mode or semiautomatic mode with manual mode override, the unit starts up in semiautomatic mode unless an AED Pro ECG cable is attached to the unit.

In semiautomatic mode, the unit analyzes the patient’s ECG through the defibrillation electrode pads attached to the patient. If the unit detects a shockable rhythm, it automatically charges to the appropriate (preconfigured) energy level. Once the defibrillator is fully charged, the Shock button begins flashing. The unit also emits a charge-ready tone, and directs the rescuer to press the Shock button to deliver therapy. In semiautomatic mode, the rescuer must deliver the shock within 30 seconds of full charge, otherwise the defibrillator automatically disarms itself, and the unit resumes ECG analysis.

After delivering a shock, the unit continues analyzin g the patient’ s ECG, guiding the rescuer to perform CPR or to deliver additional shocks, if needed.

The unit also provides CPR monitoring if ZOLL CPR-D•padz defibrillation electrodes are attached. CPR-D•padz and CPR stat•padz include a sensor to monitor the rescuer’s chest compression rate and depth. The compression data enables the unit to guide the rescuer to perform effective CPR. The unit can be preconfigured to prompt the rescuer to perform a period of CPR before the first ECG analysis cycle begins.

or CPR stat•padz

For more information, refer to Chapter 3, “Semiautomatic Mode”.

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Manual Mode Defibrillation

In manual mode, the rescuer controls each step of defibrillation therapy. The AED Pro unit displays patient ECG data and heart rate on the screen. The rescuer uses this information to determine whether or not the patient has a shockable rhythm.

If the AED Pro unit is configured for semiautomatic mode defibrillation with ECG monitoring enabled and manual mode override, and the ECG cable is not attached, the AED Pro unit starts in semiautomatic mode at power up. If the AED Pro unit is configured for manual mode defibrillation, the AED Pro unit runs only in manual mode.

When a shock is deemed necessary, the rescuer charges the defibrillator by pressing the

CHARGE softkey to charge the unit to the preconfigured energy level. Note: Defibrillation energy levels are preconfigured and cannot be changed during clinical

use.

Once the defibrillator is fully charged, the Shock button begins flashing. The unit also emits a charge-ready tone, continuously for the first 50 seconds, and then intermittently for the final 10 seconds. The rescuer must deliver the shock within this 60-second period, otherwise the defibrillator automatically disarms itself. To recharge the unit, the rescuer must press the CHARGE softkey again.

For more information, refer to Chapter 4, “Manual Mode”.

Manual Mode Defibrillation

ECG Monitoring

The optional ECG monitoring mode provides ECG rhythm and heart rate display, as well as performing background ECG analysis to detect shockable rhythms. If the AED Pro unit detects a shockable rhythm during monitoring, it immediat ely alerts the rescuer through displayed and voiced prompts; if defibrillation pads are attached, the unit automatically switches to semiautomatic mode.

For ECG monitoring, you can use

• AED Pro-compatible defibrillation electrode pads

• Standard ECG electrodes (with an AED Pro ECG cable)

While ECG electrodes (not defibrillation electrode pads) are connected to the unit, the only available mode is ECG monitoring.

All ECG monitoring is performed in the lead II configuration. The operator cannot select another lead.

For more information, refer to Chapter 5, “ECG Monitoring Mode”.

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide 1–3

CHAPTER 1PRODUCT OVERVIEW

Audio Recording

When installed and enabled, the Audio Recording Option allows the AED Pro unit to record up to 20 minutes of continuous audio and clinical event data during a rescue. (The AED Pro unit can record and store at least 5.8 hours of clinical event data when the Audio Recording Option is disabled.) The recorded audio data is synchronized to the clinical event data.

Note: The AED Pro unit records up to 3 minutes of audio data prior to electrode placement. The AED Pro unit can record and store data for only a single rescue when audio recording is

enabled — when the electrode pads are placed on the patient, the unit deletes any stored data (ECG, Audio, and Event data) and begins recording data from the current rescue.

When you start the AED Pro unit in Non-rescue Mode, it does not delete stored rescue data.

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Nonrescue Mode

The AED Pro unit provides the following functions in nonrescue mode :

• Data transfer

• Device configuration

The following sections briefly describe these functions. For more information, refer to Chapter 6, “Nonrescue Mode”.

Data Transfer

The AED Pro unit includes nonvolatile memory, which automatically records

• Device history

• Clinical data

Stored information can be transferred to a remote device (such as a comput er) th ro ugh a USB device or an IrDA (infrared wireless) connection. The clinical data format is compatible with

ZOLL RescueNet data.

The unit retains the device history and clinical data even when powered off or when the battery pack is removed. Clinical d ata is erased only when the device is powered on and electrodes are attached to a new patient. If configured to do so, the unit can store data for more than one patient.

Nonrescue Mode

Code Review software, which can be used to review and analyze the patient

Device Configuration

The AED Pro unit provides configurable settings that can be used to tailor the device for local rescue protocols and procedures. Using the ZOLL Administration Software on a personal computer, you can view or modify the unit’s configuration.

Standby State

When the unit is turned off with a go od ba ttery i nstalle d, the unit enters sta ndby stat e. While in standby, the unit periodically starts up automatically to perform a self-test, and then returns to standby . The Ready indicat or shows the result of the self-test. The frequency of self-tests wh ile the unit is in standby state is a configurable setting.

Automatic Shutoff

The unit automatically powers off if no patient connection is detected within 10 minutes (configurable).

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide 1–5

CHAPTER 1PRODUCT OVERVIEW

Accessories

The following related accessories and equipment are available.

Item REF

Adult CPR-D•padz electrodes 8900-0800-01 Adult CPR stat•padz electrodes 8900-0400 Adult stat•padz Pediatric pedi•padz ECG electrodes: 3 ECG electrodes/pouch (200

pouches / 600 electrodes) AED Pro ECG cable

Defibrillation analyzer (universal) adapter cable 8000-0804-01 Rechargeable PD 4410 battery pack

Disposable sealed lithium manganese dioxide battery pack

AED Pro carry bags

Molded vinyl case with spare battery compartment

IrDA adapter for personal computer

AED Pro simulator 8000-0829-01 See-Thru CPR

AED Pro ZOLL Administration Software (ZAS) CD 9658-0800-01 RescueNet Code

Windows: installation CD and Getting Started Guide AED Pro Service Manual 9650-0309-01 AED Pro Simulator Manual 9651-0801-01 SurePower Charger Station 8050-0030-01 SurePower Battery Pack 8019-0535-01

II electrodes

simulator

Review Standard software for

II electrodes

Smart Ready

Soft carry case

Hard case with foam cut-outs

AAMI

IEC

Standard

Smart

USB

RS-232

8900-0801-01 8900-0810-01 8900-0003

8000-0838 8000-0839

8004-0009 8004-0103-01 8004-0104-01

8000-0860-01

8000-0810-01 8000-0832-01 8000-0875-32

8000-0815 8000-0816

8009-0751-01

8000-0608-01

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A-W Accessories

The following accessories are also available for the AED Pro A-W.

Item REF

CPR-D•padz® one piece defibrillation and CPR

System Adult Electrode (Airworthy Certified) Airworthy stat•padz

Electrodes w/ Ferrite (1 pair) (Airworthy Certified) Airworthy stat•padz® II Adult Multi-Function

Electrodes w/ Ferrite (Case of 12) (Airworthy

Certified)

AED Pro ECG Cable AAMI (Airworthy Certified) 8000-0838 AED Pro A-W non-rechargeable lithium battery pack

(Airworthy Certified)

II Adult Multi-Function

Accessories

8900-0800-01

8900-0840-30

8900-0841-30

8000-0860-30

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide 1–7

CHAPTER 1PRODUCT OVERVIEW

On/Off button

Ready indicator

Display screen

Shock button

Patient cable connector

Softkeys

Battery compartment

latch

Battery compartment cover

IrDA port

Speaker

ZM040001A

Microphone (optional)

ZM050001A

USB connector

(inside battery compartment)

The Front Panel

Figure 1-1 shows the front panel of the AED Pro unit. Table 1-1 describes each of the unit’s front panel features.

Figure 1-1. AED Pro Front Panel

Figure 1-2. USB Connector

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The Front Panel

ZM040010A

This connector is a defibrillator-proof type BF patient connection.

Table 1-1. AED Pro Front Panel Features

Feature Description Shock button When the defibrillator is fully charged and ready, the Shock button

repeatedly flashes. To deli ver a shock, press and hold the button.

On/Off button To start the unit, press this button and release it within 5 seconds.

To start the unit in nonrescue mode, press and hold this button for more than 5 seconds.

To turn the unit off and place it in standby state, press and hold this button for 1 second.

Ready indicator Shows the status of the unit, based on

its last self-test. A green check indicates the unit is

ready for use. A red “X” indicates the unit is not ready

for use.

IrDA port Provides a way to connect the unit to an external device for

transferring patient data, unit status information, or conf ig uration information.

Speaker Issues voice prompts and alerts.

Battery compartment Holds the battery pack.

Battery compartment latch Provides access to the battery compartment.

Softkeys Directly below the display, two unlabeled buttons control various

functions depending on the operating mode. Labels for the softkeys appear at the bottom of the display above each softkey to indicate its function.

Patient cable connector Used for plugging in defibrillation electrodes or an AED Pro ECG

cable.

USB connector Allows you to download patient data to a USB device. Microphone (optional) Allows the AED Pro Unit to record audio rescue data. Only AED Pro

units that have been ordered with the Audio Recording Option have a microphone installed.

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide 1–9

CHAPTER 1PRODUCT OVERVIEW

Display Screen

The display screen shows the following items (depending on the activity in progress): Elapsed time — Shows the total time (in hours, minutes, and seconds) since the unit was

turned on. The counter resets to 00:00:00 after 23 hours, 59 minutes, and 59 seconds, or when the unit is turned off.

ECG size — Shows the amplitude scale for the displayed ECG in centimeters per millivolt (cm/mV). The device adjusts the scale automatically.

Heart rate and heartbeat symbol — (Manual and ECG monitoring modes only) Shows the current heart rate in beats per minute. The symbol flashes with each detected heartbeat.

Chest compression depth gauge— Shows the depth of chest compression during CPR when ZOLL CPR-D•padz are connected. The bar extends downward as the depth of compression increases, with scale marks representing 0, 1.5 inches, and 2 inches.

Softkey labels — Labels for the softkeys appear at the bottom of the display directly above each softkey to indicate its function.

Text prompts and messages — In semiautomatic mode, text prompts guide the rescuer. In all modes, messages alert the operator about problem conditions.

ECG rhythm — Displays the patient’s ECG. Shock symbol and number of shocks delivered — Shows the number of shocks delivered

since the unit was powered on. Current mode — Displays MANUAL in manual mode, or MONITOR in ECG monitoring

mode. No mode label appears in semiautomatic mode.

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The Front Panel

00:03:45

142

MANUAL

CHARGE

ECG X0.5

150 J SELECTED

Elapsed time Heart rate and

heartbeat symbol

ECG rhythm

Text prompts

and messages

Number of shocks

delivered

Chest compression depth gauge (with CPR-D•padz only)

Current mode

Left softkey

label location

Right softkey label location

ECG size

Shock symbol

Figure 1-3 shows the layout of the screen and the location of the above items.

Figure 1-3. AED Pro Display Screen Elements

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AED PRO OPERATOR’S GUIDE

(This page intentionally left blank.)

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide 1-12

Chapter 2

Getting S t arted

This chapter describes some common tasks that you must do to get the AED Pro unit ready to use, and contains the following sections:

• “Installing a Battery Pack” on page 2-2

• “Preparing the Unit for Clinical Use” on page 2-5

• “Performing a Self-Test” on page 2-6

• “Preconnecting the Defibrillation Electrodes Cable” on page 2-7

• “Messages” on page 2-8

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide 2–1

CHAPTER 2GETTING STARTED

ZM040004A

Installing a Battery Pack

The AED Pro unit accepts the following types of battery packs:

• Rechargeable PD 4410-series battery packs

• Disposable sealed lithium manganese dioxide battery packs

• SurePower rechargeable lithiu m io n bat tery packs

When the unit displays the message CHANGE BATTERY, imme diatel y replace t he batte ry with a fully charged battery pack.

Before you begin

Be sure the unit is turned off. Be sure the battery pack to be installed is fully charged.

WARNING! Do not use a rechargeable battery pack if the unit’s standby period will exceed 90 days.

Procedure

To install or replace a battery pack:

Step Action Notes

1 Pull the bottom edge of the battery

compartment latch outward. When released, the latch slides upward.

2 Pull the top edge of the latch toward you

and then downward.

3 Lift the edge of the battery compartment

cover.

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Step Action Notes

ZM040006A

ZM040005A ZM040007A

ZM040007A

4 Slide out the cover panel. 5 If a battery is installed, remove it from the

compartment by pressing the tab on the battery pack.

Installing a Battery Pack

6 Align the tab of the new battery with the

finger access area on the left side of the battery compartment, then place the battery into the compartment.

7 Press the edge of the battery pack until it

clicks into place.

8 Slide the cover panel back into place, and

then lower the edge of the cover.

The shape of the battery pack allows it to seat itself properly .

9 Raise the compartment latch, and tilt the

top edge toward the unit.

10 Press the bottom edge of the latch toward

the unit to lock the cover in place.

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide 2–3

CHAPTER 2GETTING STARTED

Important: If you change the battery while the unit is in clinical use (that is, with a cable

connected), the unit automatically powers on in nonrescue mode and then shuts down. Press and release the On/Off button to restart the unit.

CHANGE BATTERY Warning

When the unit detects a low energy condition, it issues the voice and text prompt CHANGE BATTERY o nce every minute. Depe nding on the ag e and condition of the battery, the remaining

operating time of the unit might be extremely limited. The warning message continues until the device shuts down.

WARNING! T o ensur e the availability of adequate power during an emer gency, keep a fully charged

spare battery pack with the device at all times.

Whenever the unit issues the prompt CHANGE BATTERY, immediately replace the used battery pack with a fully charged one to ensure continuous operation and to avoid unexpected device shutdown. After removing a depleted rechargeable battery pack from the unit, recharge the pack as soon as possible.

Battery Condition Indications Correction

Low energy detected during power-on self-test.

Low energy or other self-test failure while the unit is powered off (standby).

Low energy detected while the unit is powered on.

Dead battery Ready indicator shows a

Message: CHANGE BATTERY

Ready indicator shows a red “X”. Unit beeps once every minute for 30 minutes.

Message:

CHANGE BATTERY

red “X”.

Replace battery pack.

Replace battery pack. Check or replace

preconnected electrodes. If the red “X” remains, contact

ZOLL Technical Service. Replace battery pack as soon

as possible. Replace battery pack. If the red “X” remains, contact

ZOLL Technical Service.

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Preparing the Unit for Clinical Use

The following setup and checkout procedures should be performed before placing the unit into service and after each clinical use.

Before you begin

You need the following items:

• A fully charged battery

• Defibrillation electrode pads

Procedure

To prepare an AED Pro unit for clinical use:

Step Action

1 Inspect all external surfaces of the unit to ensure that they are clean (with no flu id spills)

and free from structural damage, such as cracks and broken or missing parts.

2 Inspect the patient cable connector to ensure that the pins are not broken, bent, or missing.

Preparing the Unit for Clinical Use

3 Inspect all cables. Repl ace any item that is cut or frayed, or that has bent pins. 4 Install a fully charged battery pack that is appropriate for your application. 5 Ensure that you have an adequate supply of defibrillation and ECG electrodes. 6 Verify that the defibrillation electrodes have not expired and are not close to expiration. 7 Follow the instructions provided with the defibrillation electrodes to preconnect them to the

patient cable connector.

Note: If electrodes are not preconnected, the unit will fail its next self-test in standby state.

8 Press and release the On/Off button to turn on the unit and initiate a power-on self-test.

The message UNIT OK indicates that the battery pack and electrodes are properly installed and that the unit is ready for service.

The message UNIT FAILED ind icates that the unit is not ready for servi ce.

9 Verify that the unit correctly detects the type of electrodes that are attached (with the

message ADULT PADS or PEDIATRIC PADS).

10 Press and hold the On/Off button for 1 second to turn off the unit. 11 Wait 2 minutes. Verify that the Ready indicator displays a green check, and that the unit

does not beep.

12 Place the unit into service.

While the unit is in service, periodically check the Ready indicator to ensure that it displays a green check and inspect the unit for physical damage.

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide 2–5

CHAPTER 2GETTING STARTED

ZM040010A

VERSIONS

00:00:12

UNIT OK

B:01.51 L:01.67 P:02.61 H:02.00 C:02.00

USB

SET TIME

Performing a Self-Test

The AED Pro unit performs automatic or manual self-tests to verify its integrity and readiness for emergency use. These tests verify the following:

• Battery energy — Verifies that the battery energy is sufficient for at least 2 hours of

continuous monitoring and ten shocks at maximum energy.

• Defibrillation electrodes connection — Verifies that defibrillation electrodes are properly

preconnected to the unit.

• ECG circuitry — Verifies that the ECG signal acquisition and processing electronics are

functional.

• Defibrillator charge and discharge circuitry — Verifies that the defibrillator electronics are

functional and can charge and discharge at 2 joules.

• Microprocessor hardware and software — Verifies the proper function of the

microprocessor electronics and the integrity of the software.

• CPR circuitry and sensor — Verifies that the CPR monitoring and compression depth

detection are functional (when CPR-D•padz or CPR stat•padz are attached).

• Audio circuitry — Verifies that the audio output circuitry is functional.

• Display — Verifies that the visual indicators are functional.

After the successful completion of the self-test, the Ready indicator displays a green check, indicating that the unit is ready for use.

Automatic Self-Tests

The unit performs a self-test whenever it is turned on or a battery pack is installed, or at periodic intervals while in standby state. The interval for automatic self-tests in standby state is a configurable setting; the default interval is one day. For more information, refer to Appendix C, “Configurable Settings”.

Manual Self-Test

You can manually initiate a self-test by pressing and holding the On/Off button for 5 seconds. The unit illuminates the Shock button and issues voice and text messages so that you can verify the visual and auditory output functions. In addition, the screen shows information about the unit’s hardware and software.

If the Ready indicator displays a red “X” after a self-test, the unit is not ready for use and might be defective. Remove the unit from service and consult the Troubleshooting chapter of this guide.

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Preconnecting the Defibrillation Electrodes Cable

ZM040008A

Preconnecting the Defibrillation Electrodes Cable

WARNING! To prepare for an emergency, keep the defibrillation electrodes cable connected to the

unit at all times.

WARNING! Do not reuse defibrillation electrodes.

The AED Pro unit supports both adult and pediatric electrode pads. The device adjusts defibrillation energy to adult or pediatric levels depending on the type of electrodes connected to it. Always use electrode pads that are appropriate for the patient.

WARNING! Do not use adult defibrillation electrode pads or CPR-D•padz on patients under 8 years

of age.

The electrode packaging allows you to connect the cable to the unit while the pads remain in a sealed envelope.

• To prepare for future emergencies, after each use connect a new package of electrodes by

plugging the electrode cable into patient cable connector.

• T o ensure that the ele ctrodes are fresh and ready to use in an emer ge ncy, regularly check the

electrode expiration date on the preconnected electrode pack.

• Replace expired electrodes.

• After completing its power-on self-test, the unit issues a voice and text message to indicate

the type of electrodes that are connected (ADUL T PADS or PEDIATRIC PADS). Verify that the connected electrodes are appropriate for the patient. If necessary, replace the connected electrodes with appropriate ones.

If the electrode cable is not properly connected to the unit, the unit issues the voice and text prompt PLUG IN CABLE.

If the electrodes are not properly attached to the patient, the unit issues the voice and text prompt CHECK DEFIB PADS or ATTACH DEFIB PADS TO PATIENT’S BARE CHEST.

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide 2–7

CHAPTER 2GETTING STARTED

Messages

While preparing the AED Pro unit for use, the following messages can be seen and/or heard:

Message Description

UNIT OK The unit successfully passed its power-on self-test.

UNIT FAILED The unit failed its power-on self-test and is not usable

CHANGE BATTERY The self-test detected a low energy condition that is

for patient care.

insufficient for patient care. Replace the battery pack immediately.

ADUL T PADS PEDIATRIC PADS

PLUG IN CABLE The unit started up without an electrode cable plugged

NON-RESCUE MODE The device is operating in nonrescue mode and an IrDA

POWERING OFF The On/Off button was pressed and held for 1 second

The unit detected the specified type of electrode pads and adjusted defibrillation energy settin gs ac cordingly.

in. Plug the cable into the unit.

connection is established.

to turn the unit off.

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Chapter 3

Semiautomatic Mode

In semiautomatic mode, the unit uses voice prompts and visual indicators to guide the rescuer through a resuscitation sequence that can include defibrillation and/or cardiopulmonary resuscitation (CPR).

AED models start up in semiautomatic mode unless an AED Pro ECG cable is connected to the unit. For more information, refer to Chapter 5, “ECG Monitoring Mode”.

After guiding the rescuer through patient assessment by issuing voice and text messages, the unit issues the voice and text prompt DON’T TOUCH PATIENT, ANALYZING. The unit then begins analysis of the patient’s ECG to determine whether the rhythm is shockable or not and announces and displays the result (SHOCK ADVISED or NO SHOCK ADVISED).

If defibrillation is needed, ECG analysis ends and the unit charges to the preconfigured energy level. When charged, the unit emits a charge-ready tone, repeatedly flashes the Shock button, and issues the voice and text prompt PRESS FLASHING SHOCK BUTTON. After the rescuer presses the button to deliver therapy, the unit resumes analysis and can guide the rescuer through an escalating series of three shocks if necessary.

This chapter contains the following sections:

• “Applying Defibrillation Electrode Pads” on page 3-2

• “Semiautomatic Defibrillation” on page 3-9

• “Messages in Semiautomatic Mode” on page 3-12

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide 3–1

CHAPTER 3SEMIAUTOMATIC MODE

Applying Defibrillation Electrode Pads

To deliver defibrillation therapy to a patient, you must use AED Pro-compatible defibril lat ion electrode pads:

• ZOLL CPR-D•padz (adult patients; includes CPR sensor)

• CPR stat•padz (adult patients; includes CPR sensor)

• ZOLL stat•padz® II (adult patients)

• ZOLL pedi•padz® II (pediatric patients)

Defibrillation electrode pads connect to the AED Pro unit through the patient cable connector. Preconnect a set of electrode pads so that they are ready for use in an emergency.

WARNING! Do not open the sealed electrodes until immediately prior to use.

You can also use defibrillation electrode pads for ECG monitoring. Before applying defibrillation electrode pads to the pat ient, be sure to

• Remove all clothing covering the patient’s chest.

• Clip or shave any excessive hair to ensure proper adhesion of the pads.

• Use alcohol to wash away any oil or dirt at the electrode site.

• Dry any moisture at the electrode site.

WARNING! Poor adherence or air p ockets under the de fibrillation electr ode pads can lead to ar cing,

skin burns, or reduced energy delivery.

For proper placement of electrodes for defibrillation, refer to the graphics on the electrode packaging.

Check the expiration date on the defibrillation electrode packaging. Do not use expired pads.

This symbol on the electrode label is accompanied by the expiration date.

Note: ZOLL electrodes contain no hazardous materials and may be disposed of in general

trash unless contaminated with pathogens. Use appropriate precautions when disposing of contaminated electrodes.

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Applying Defibrillation Electrode Pads

Applying Defibrillation Electrode Pads — Adult CPR-D•padz

WARNING! ZOLL CPR-D•padz are for adult patients only; do not use them on patients under

8 years of age.

To apply CPR-D•padz defibrillation electrodes:

Step Action

1 Tear open the electrode package and unfold the

electrodes.

2 Using the cross hairs on the CPR sensor to guide you,

place the sensor on the middle of the patient’s breastbone, between the nipples.

3 Hold the CPR sensor in place with your right hand, and

use your left hand to pull the number 2 tab and peel the protective backing from the electrode.

Note: If the patient has an implanted pacemaker or

defibrillator in his/her upper right chest, angle the electrode slightly to avoid placing it over the device. Ensure that the CPR sensor remains over the lower half of the breastbone.

Press the electrode from the center of the chest outward to push out air from beneath the pad, and to make sure the pad adheres properly to the patient’s skin.

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CHAPTER 3SEMIAUTOMATIC MODE

Step Action

4 Hold the CPR sensor in place with your left hand, and

use your right hand to pull the number 3 tab and peel the protective backing from the electrode.

Press the electrode from the center of the abdomen outward to push out air from beneath the pad, and to make sure the pad adheres properly to the patient’s skin.

If the patient is large or there is a need to place the electrode under a breast, you can detach the lower pad at the perforation and extend it for effective positioning.

Place the pad slightly to the patient’s left and below the patient’s left breast.

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Applying Defibrillation Electrode Pads

Applying Defibrillation Electrode Pads — Adult CPR stat•padz

WARNING! ZOLL CPR stat•padz are for adult patients only; do not use them on patients under

8 years of age.

To apply CPR stat•padz defibrillation electrodes:

Step Action

1 Tear open the electrode package and expose the

electrodes. Grasp the square electrode at the bottom (with the attached sensor) and peel from the plastic liner.

2 Place the CPR sensor on the sternum, lining up the

cross hairs with the patient’s nipple line and center of the sternum. Place the electrode in the mid clavicular line below the patient’s right clavicle as shown in the diagram. Avoid any contact between the nipple and gel treatment area.

3 Gently roll the electrode onto the chest, pushing any air

out from beneath the electrode. Note: If the patient has an implanted pacemaker or

defibrillator in his/her upper right chest, angle the electrode slightly to avoid placing it over the device. Ensure that the CPR sensor remains over the lower half of the breastbone.

4 Grasp the round electrode at the bottom and peel it

from the plastic liner. Apply the electrode so it lines up with the bottom of the pectoral muscle on a male patient, as shown in the diagram. For female patients, place the electrode under the breast.

Note: A more lateral placement increases the

likelihood that more of the heart musculature will be within the current.

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CHAPTER 3SEMIAUTOMATIC MODE

CPR Monitoring with CPR-D•padz and CPR stat•padz

ZOLL CPR-D•padz and CPR stat•padz electrodes include a sensor that detects the rate and depth of chest compressions. When the electrodes are properly positioned on the patient, the sensor lies between the rescuer’s hands and the patient’s lower sternum. While the rescuer performs chest compressions, the sensor detects the rate and depth and sends the information to the AED Pro unit.

If the unit does not detect chest compressions during a CPR period, it periodically issues the voice and text prompt CONTINUE CPR (if configured to do so).

ZOLL CPR-D•padz and CPR stat•padz electrodes can be connected to other ZOLL defibrillators, and defibrillation can be administered through other ZOLL defibrillators. The CPR function, however , d oes not o perate with any device other than the ZOLL AED Pro or the

ZOLL AED Plus

Chest compression rate

With CPR-D•padz and CPR stat•padz, the unit provides a metronome function to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute.

When CPR is indicated, the metronome begins to beep after detecting the first few chest compressions. The metronome continues (at rates described below) until a few seconds after the rescuer halts compressions or until the recommended CPR period ends (2 minutes for AHA and ERC protocols).

The metronome beeps 100 times per minute to encourage the rescuer to increase the rate of chest compressions to achieve the recommended rate of 100 cpm.

During the CPR period, if the rescuer stops chest compressions, the metronome stops within a few seconds. If chest compressions resume, the metronome starts again.

The metronome is disabled whenever CPR should not be performed (for example, during ECG analyses and defibrillation shock sequences).

Chest compression depth

With CPR-D•padz and CPR stat•padz, the unit provides visual indicators and voice prompts to encourage a chest compression depth of 1.5 to 2 inches (3.8 to 5.0 cm) for adult patients.

The screen displays a gauge, which shows the dept h of chest compressio ns. Compression de pth is correct when the bar extends downward between the lower two lines, which represent 1.5 and 2 inches (3.8 to 5.0 cm).

When the detected compression depth is consistently less than 1.5 inches (3.8 cm), the unit issues the voice and text prompt PUSH HARDER. If the rescuer responds by increasing compression depth to 1.5 inches (3.8 cm) or more, the unit issues the voice and text message GOOD COMPRESSIONS.

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Applying Defibrillation Electrode Pads

Applying Defibrillation Electrode Pads — Adult stat•padz II

WARNING! ZOLL stat•padz II electrodes are for adult patients only; do not use them on patients

under 8 years of age.

To apply stat•padz II defibrillation electrode pads:

Step Action

1 Tear open the electrode package and unfold the inner

package to expose the electrodes.

2 Remove the square electrode from its backing material,

and place it on the patient’s upper right chest as shown.

3 Place your hand on the electrode edge. Using your

other hand, gently roll the electrode onto the patient’s chest, pushing out air from beneath the electrode as you go.

4 Remove the round electrode from its backing material,

and place it on the patient’s lower left chest as shown.

5 Place your hand on the electrode’s edge. Using your

other hand, roll the electrode onto the patient’s skin, pushing out air from beneath the electrode as you go.

For female patients, place the electrode under the patient’s left breast.

6 Follow the AED Pro prompts.

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CHAPTER 3SEMIAUTOMATIC MODE

Applying Defibrillation Electrode Pads — Infant/Child pedi•padzII

WARNING! ZOLL pedi•padz II electrodes are for pediatric patients only; these pads provide

defibrillation energy levels that might be inadequate for adult patients.

Procedure

To apply pedi•padz II defibrillation electrode pads:

Step Action

1 Tear open the electrode package and unfold the inner

package to expose the electrodes.

2 Remove the round electrode from its backing material.

3 Position the electrode on the patient’s chest as shown.

Place your hand on the electrode edge. Using your other hand, gently roll the electrode onto the patient’s chest, pushing out air from beneath the electrode as you go.

4 Roll the patient onto his/her chest. 5 Remove the square electrode from its backing material. 6 Position the electrode on the patient’s back as shown.

Place your hand on the electrode’s edge. Using your other hand, roll the electrode onto the patient’s skin, pushing out air from beneath the electrode as you go.

7 Roll the patient onto his/her back, and follow the

AED Pro prompts.

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Semiautomatic Defibrillation

In semiautomatic mode, the AED Pro unit analyzes the patient’s ECG rhythm to determine whether it is shockable or not. If a shock is needed, follow the text and voice prompts to defibrillate the patient.

WARNING! During ECG analysis, do not touch or move the patient. If conveying the patient in a

vehicle or stretcher, cease all patient movement.

After an ECG analysis resulting in delivery of a shock, or after any no-shock-ad vised result, the unit initiates a period of CPR.

Note: If the AED Pro unit is configured to use a two or three shock sequence, the unit

initiates a period of CPR after two episodes of ECG analysis and shock (two shock sequence) or three successive episodes of ECG analysis and shock (three shock sequence), or after a no-shock-advised result.

In semiautomatic mode, the screen shows the shock count, elapsed time, ECG size, ECG rhythm, and text messages.

If CPR-D•padz or CPR stat•padz are attached to the patient, the screen includes a chest compression gauge that shows the depth of each chest compression as detected by the CPR sensor.

02:04:45

ECG X1.5

GOOD COMPRESSIONS

The rhythm recognition detector continues analyzing the ECG after detecting a shockable rhythm and the defibrillator is charged and ready but will not bring the unit into a state where defibrillation is prohibited.

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide 3–9

CHAPTER 3SEMIAUTOMATIC MODE

Before you begin

Be sure the defibrillation cable is plugged into the unit.

Procedure

To defibrillate the patient in semiautomatic mode:

Step Action Result

1 Press and release the On/Off button to turn

on the unit.

2 If prompted, apply defibrillation electrode

pads to the patient. (Refer to “Applying Defibrillation Electrode

Pads” on page 3-2.)

3 Allow the unit to analyze the patient’s ECG. The unit determines whether or not the

On successful completion of the power-on self-test, the unit issues the voice an d te xt message:

UNIT OK

and then indicates the type of attached electrodes.

If the defibrillation pads are not attached to the patient, the unit issues the voice and text prompt:

ATTACH DEFIB PADS TO PATIENT’S

BARE CHEST

When the pads are properly attached to the patient, the unit issues the voice and text message:

DON’T TOUCH PATIENT, ANALYZING

and then begins ECG analysis.

patient has a shockable rhythm and then displays and voices its recommendation:

SHOCK ADVISED

NO SHOCK ADVISED

4 After ECG analysis, which message

appears? — If SHOCK ADVISED, continue with step 5.

— If NO SHOCK ADVISED, go to step 8.

5 Wait for the defibrillator to charge. When fully charged, the unit emits a

If a shock is needed, the defibrillator automatically begins charging.

If a shock is not needed, the unit prompts you to perform CPR.

charge-ready tone, repeatedly flashes the Shock button, and issues the voice and text prompts:

DON’T TOUCH PATIENT

PRESS FLASHING SHOCK BUTTON

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Semiautomatic Defibrillation

ZM040011A

Step Action Result

WARNING! You have 30 seconds to perform the following step, otherwise the

defibrillator automatically disarms itself. (During the final 10 seconds, the charge-ready tone sounds intermittently to indicate that time is expiring.)

Before discharging the defibrillator, warn everyone to STAND CLEAR. Verify that no one is touching the patient, the bed rails, or any other potential pathway for electrical current.

6 Press and hold the Shock button until

treatment is delivered.

7 Does the unit resume ECG analysis?

— If NO, continue with step 8. — If YES, return to step 3.

8 Follow the prompts to perform CPR, until

directed to stop.

(CPR-D•padz or CPR stat•padz only) After the first few chest compressions, the metronome begins beeping. Try to time each compression with the metronome beep. Check the on-screen gauge to ensure that the compression depth is adequate.

The unit delivers the shock and updates the shock count.

Depending on the number of shocks that have been delivered, the unit either resumes ECG analysis or prompts you to perform CPR.

When the unit resumes ECG analysis, it displays the message:

DON’T TOUCH PATIENT, ANALYZING

The unit displays the message:

START CPR

At the end of the defined CPR period, the unit displays the message:

STOP CPR

Note: If CPR-D•padz or CPR stat•padz are attached, the unit also monitors the rate and depth of chest compressions and can issue these related voice and text prompts:

• PUSH HARDER

• GOOD COMPRESSIONS

In addition, if the unit does not detect chest compressions, it issues the following voice and text prompt every 15 seconds:

• CONTINUE CPR

9 When the unit resumes ECG analysis, return

to step 3.

During ECG analysis, keep the patient motionless, and do not touch the patient.

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide 3–11

CHAPTER 3SEMIAUTOMATIC MODE

Start with CPR Option

Your AED Pro unit may be configured to start a rescue with a CPR period of 30 to 180 seconds that begins after you power on the AED Pro unit. You can end this initial CPR period at any time by pressing the Analyze softkey. When you press the Analyze softkey, the AED Pro unit immediately begins analyzing the patient’s ECG rhythm if the electrode pads are attached correctly. The Analyze softkey appears only during the initial CPR period and does not appear during any subsequent CPR periods unless it is configured to do so and/or the subsequent CPR intervals are set to Extended.

Messages in Semiautomatic Mode

During semiautomatic mode, the unit can issue the following voice prompts and text messages. The unit issues each voice prompt only once, bu t the equivalent message remains on the screen until you take action, time expires, or the device status changes.

Message Description

UNIT OK The unit successfully passed the power-on self-test.

UNIT FAILED The unit failed the power-on self-test and is not usable for

CHANGE BATTERY The self-test detected a low energy condition that is insufficient

ADUL T PADS PEDIATRIC PADS PLUG IN CABLE The unit started up without an electrode cable plugged in. Plug

ATTACH DEFIB PADS TO PATIENT’S BARE CHEST

CHECK PATIENT Check the patient for responsiveness or consciousness by

CHECK PULSE Check the patient for a pulse or other signs of circulation, such

START CPR Indicates the beginning of a CPR period. Begin CPR. STOP CPR Indicates the end of the CPR period. Discontinue CPR.

patient care.

for patient care. Replace the battery pack immediately. The unit detected the specified type of electrode pads and

adjusted defibrillation energy settings accordingly.

the cable into the unit. The unit does not detect attachment of the defibrillation

electrode pads to the patient. Check the cable for damage. Make sure that the pads are properly applied to the patient. If this message continues, check the electrode sites to ensure

that they are clean, dry, and free of excess hair. Check the expiration date on the electrode package.

gently shaking the patient and shouting “Are you all right?”

as normal breathing, movement, or coughing.

DON’T TOUCH PATIENT, ANALYZING

NO SHOCK ADVISED ECG analysis did not de tect a shockable rhythm.

SHOCK ADVISED ECG analysis detected a shockable rhythm that requires

Indicates the beginning of an ECG analysis period. Make sure everyone stands clear of the patient. Keep the patient motionless during ECG analysis.

therapy.

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Semiautomatic Defibrillation

Message Description

DON’T TOUCH PATIENT The unit is analyzing the patient’s ECG, charging the

defibrillator, or holding a charge. Do not touch the patient.

PRESS FLASHING SHOCK BUTTON

RELEASE SHOCK BUTTON The Shock button was depressed too soon. Wait until the unit

CHECK DEFIB PADS The defibrillation electrode pads became disconnected.

RELEASE LEFT SOFTKEY

RELEASE RIGHT SOFTKEY ANALYSIS HALTED. KEEP

PATIENT STILL.

SHOCK DELIVERED A shock was delivered to the patient.

After detecting a shockable rhythm, the unit is charged to the preselected energy level. Within 30 seconds, press the Shock button to deliver a shock to the patient.

issues the prompt PRESS FLASHING SHOCK BUTTON.

Check the pads to ensure that they are properly applied to the patient, and verify that the cable is undamaged and plugged into the unit.

A softkey was pressed for more than 10 seconds. Release the softkey.

ECG rhythm analysis halted due to excessive ECG signal artifact. Stop CPR, and keep the patient as motionless as possible.

NO SHOCK DELIVERED No shock was delivered to the patient because the rescuer

failed to press the Shock button, or an error condition was detected.

STAY CALM Relax as much as possible and focus on the rescue effort.

CALL FOR HELP Activate the local emergency medical services (EMS) system

or ask a bystander to do it for you.

OPEN AIRWAY Place the patient in the supine position and perform a head tilt,

chin lift, or jaw thrust to open the patient’s airway.

CHECK BREATHING Look, listen, or feel for signs of breathing or airflow from the

patient’s lungs.

GIVE TWO BREATHS If the patient is not breathing, give two rescue breaths.

CONTINUE CPR (Optional prompt) Perform CPR until directed to stop. PUSH HARDER (With CPR-D•padz and CPR stat•padz only) Apply more force

so that chest compressions are at least 1.5 inches (3.8 cm) deep. Observe the compression indicator on the display screen.

GOOD COMPRESSIONS (With CPR-D•padz and CPR stat•padz only) The unit dete cted

proper chest compression depth during CPR.

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide 3–13

CHAPTER 3SEMIAUTOMATIC MODE

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Chapter 4

Manual Mode

In manual mode, the AED Pro unit displays the patient’s ECG, while the rescuer evaluates the rhythm to determine if a shock is needed. The rescuer can charge the unit to a preselected energy level. Once the defibrillator is fully charged, the rescuer presses the Shock button to deliver therapy.

Note: Manual mode is not available on AED-only models. This chapter contain s the following sections:

• “About Manual Mode” on page 4-2

• “Switching to Manual Mode” on page 4-3

• “Manual Defibrillation” on page 4-4

• “See-Thru CPR” on page 4-5

• “Messages in Manual Mode” on page 4-10

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide 4–1

CHAPTER 4MANUAL MODE

About Manual Mode

In manual mode, you must evaluate the patient’s rhythm to determine whether or not it is shockable. If a shock is required, you manually charge the defibrillator to the preselected energy level.

Once the defibrillator is fully charged, the Shock button begins flashing. The unit also emits a charge-ready tone to indicate that the defibrillator is ready to deliver a shock. The tone is continuous for the first 50 seconds and then sounds intermittently for 10 seconds more. Press the Shock button to deliver therapy.

If you do not deliver a shock within this 60-second period, the defibrillator automatically disarms itself. To recharge the defibrillator, you must press the CHARGE softkey again.

WARNING! During shock delivery, do not touch the patient or any other equipment connected to

the patient. A severe shock can result. To avoid unwanted pathways for defibrillation current, do not allow exposed portions of the patient’ s body to touch metal objects, such as a bed frame.

In manual mode, the screen shows the shock count, elapsed time, mode (MANUAL), heart rate, heartbeat symbol, ECG size, ECG rhythm, text messages, and the label CHARGE or DISARM above the left softkey.

CHARGE

00:03:45

MANUAL

150 J SELECTED

142

ECG X1.5

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Switching to Manual Mode

When the unit is operating in semiautomatic mode, you can override the automated functions and switch to manual operation. Changing modes does not affect the preselected energy level.

Before you begin

Be sure the defibrillation electrode pads are properly attached to the patient and are plugged into the unit. (For more information, refer to Chapter 3.)

Procedure

To override semiautomatic mode and begin manual mode:

Step Action Result

Switching to Manual Mode

1 Press and hold both (unlabeled) softkeys

simultaneously for at least 3 seconds.

2 To change to manual mode, press the

MANUAL softkey.

Or to remain in semiautomatic mode, press the SEMI-AUTO softkey.

Note: If you do not press either softkey

within 10 seconds, the unit reverts to semiautomatic mode.

The MANUAL and SEMI-AUTO softkey labels appear.

The unit changes to manual mode, and displays the CHARGE softkey label.

To return to semiautomatic mode after manual override, turn the unit off and then back on again.

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide 4–3

CHAPTER 4MANUAL MODE

ZM040011A

Manual Defibrillation

With manual defibrillation, you must evaluate the ECG rhythm to determine whether or not it is shockable. If a shock is needed, you manually charge the defibrillator and then deliver a shock to the patient.

Before you begin

Prepare the patient as described in “Applying Defibrillation Electrode Pads” on page 3-2.

Procedure

To manually defibrillate the patient:

Step Action Result

1 Press the CHARGE softkey to begin

charging the defibrillator. If you need to disarm the defibrillator before

it reaches full charge, press the DISARM softkey.

The unit displays the message:

DON’T TOUCH PATIENT, CHARGING

The CHARGE softkey label changes to DISARM.

The charge-ready tone indicates that the defibrillator is charged and ready. The Shock button flashes repeatedly.

WARNING! You have 60 seconds to perform the following step, otherwise the

defibrillator automatically disarms itself. (During the final 10 seconds, the charge-ready tone sounds intermittently to indicate that time is expiring.)

Before discharging the defibrillator, warn everyone to STAND CLEAR. Verify that no one is touching the patient, the bed rails, or any other potential pathway for electrical current.

2 Press and hold the Shock button until

treatment is delivered.

Or to disarm the defibrillator, press the DISARM softkey.

The unit delivers the shock to the patient. The unit updates the shock count and shows

the energy level for the next shock:

XXX J SELECTED

3 Continue evaluating the patient.

If additional shocks are needed, repeat this procedure.

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See-Thru CPR

See-Thru CPR® enables the rescuer to see a close approximation of the patient’s underlying ECG rhythm while performing CPR. See-Thru CPR is an optional feature that must be configured using the ZOLL Administration Software.

Chest compressions introduce CPR artifact into the ECG signal. See-Thru CPR uses a filter that relies on the correlation between CPR compressions, as detected by the ZOLL CPR-D•padz or CPR stat•padz electrodes, and the CPR artifact to remove much, but not al l, of the artifact from the ECG signal. Under some conditions, residual noise after filtering can obscure the ECG rhythm, requiring the rescuer to stop CPR to assess the ECG. For example, in the case of asystole or low amplitude PEA, the residual artifact seen after filtering may look like fine ventricular fibrillation.

Because the filtered ECG signal may contain residual chest compression and/or filtering artifacts, a rescuer should always follow the standard protocol of stopping CPR to assess the patient’s ECG rhythm before determining treatment.

Using See-Thru CPR

To use See-Thru CPR:

• The AED Pro unit must be operating in Manual Mode.

• CPR-D•padz or CPR stat•padz electrodes must be attached to the unit.

• The AED Pro unit must be configured to use See-Thru CPR (using the ZOLL

Administration Software).

When a rescue begins, an AED Pro unit that has been configured to use See-Thru CPR automatically starts filtering the CPR artifact after detecting the first 3 to 6 chest compressions. The filtered ECG is displayed along with the CPR FLTR message on the top left of the LCD screen.

See-Thru CPR

WARNINGS

See-Thru CPR filtering continues as long as the CPR-D•padz or CPRstat•padz electrodes detect compressions. When no compressions are detected, filtering stops, unfiltered ECG signals are displayed, and the unit removes the CPR FLTR message from the LCD screen. When compressions resume, filtering automatically restarts after 3 to 6 chest compressions.

• The See-Thru CPR filter works only when the AED Pro defibrillator is operating

in Manual Mode.

• The See-Thru CPR filter does not remove all CPR artifact. Always stop CPR to

verify the patient’s ECG rhythm before making treatment decisions.

• The See-Thru CPR filter does not operate during ECG rhythm analyses. Always

stop chest compressions during ECG rhythm analyses to avoid incorrect results caused by the presence of CPR artifact.

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide 4–5

CHAPTER 4MANUAL MODE

FineVF

0:00 0:12

Raw ECG Raw ECG

Filtered ECG Filtered ECG

CPR CPR

| Filter ON

•

FineVF

0:12 0:24

Raw ECG Raw ECG

Filtered ECG Filtered ECG

CPR CPR

| Filter OFF

• | Filter ON

•

FineVF

0:24 0:36

Raw ECG Raw ECG

Filtered ECG Filtered ECG

CPR CPR

| Filter OFF

•

12.5 mm/sec, 5 mm/mV

Examples

The following examples show the effects of See-Thru CPR filtering on ECG signals contaminated with CPR artifact.

Each example includes:

• ECG signal with CPR artifact.

• ECG signal after the See-Thru-CPR filter has removed CPR artifact.

• Indication of the period during which See-Thru CPR is active.

• CPR signal to show when CPR activity occurred.

Figure 1 shows a patient in Fine VF. It is difficult for a rescuer to discern this rhythm during CPR compressions. When the CPR filter turns on, the Fine VF rhythm becomes more obvious.

Figure 1.

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CoarseVF

0:00 0:12

Raw ECG Raw ECG

Filtered ECG Filtered ECG

CPR CPR

CoarseVF

0:12 0:24

Raw ECG Raw ECG

Filtered ECG Filtered ECG

CPR CPR

| Filter ON

•

CoarseVF

0:24 0:36

Raw ECG Raw ECG

Filtered ECG Filtered ECG

CPR CPR

| Filter OFF

•

12.5 mm/sec, 5 mm/mV

See-Thru CPR

Figure 2 shows a patient in VF, which during compressions, is slightly more difficult to discern. When viewing this ECG, it is possible to view the underlying rhythm as the filter is able to reject all of the CPR artifact.

Figure 2.

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide 4–7

CHAPTER 4MANUAL MODE

Asystole

0:00 0:12

Raw ECG Raw ECG

Filtered ECG Filtered ECG

CPR CPR

| Filter ON

•

Asystole

0:12 0:24

Raw ECG Raw ECG

Filtered ECG Filtered ECG

CPR CPR

| Filter OFF

• | Filter ON

•

Asystole

0:24 0:36

Raw ECG Raw ECG

Filtered ECG Filtered ECG

CPR CPR

| Filter OFF

•

12.5 mm/sec, 5 mm/mV

Figure 3 shows a patient in PEA, which could easily be mistaken for Fine VF because enough of the compression artifact leaks through to distort this signal. When th e CPR filter turns on, the PEA is still not obvious because of the left over ripples from the CPR signal. About 14 seconds into this chart, the rhythm chan ges to asystole, which could easily be mistaken for coarse VF. When the CPR filter turns on, the CPR compression ripples are still obvious, making the rhythm look like Fine VF.

Figure 3.

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SinusRhythm

0:00 0:12

Raw ECG Raw ECG

Filtered ECG Filtered ECG

CPR CPR

| Filter ON

•

SinusRhythm

0:12 0:24

Raw ECG Raw ECG

Filtered ECG Filtered ECG

CPR CPR

| Filter OFF

• | Filter ON

•

SinusRhythm

0:24 0:36

Raw ECG Raw ECG

Filtered ECG Filtered ECG

CPR CPR

| Filter OFF

•

12.5 mm/sec, 5 mm/mV

See-Thru CPR

Figure 4 shows a patient with an organized rhythm where See-Thru CPR effectively filters out artifact created by CPR.

Figure 4.

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide 4–9

CHAPTER 4MANUAL MODE

Messages in Manual Mode

During manual mode, the following messages can be displayed:

Message Description

PLUG IN CABLE The unit started up without an electrode cable plugged

CHECK DEFIB PADS The defibrillation electrode pads became disconnected.

CHECK PATIENT Evaluate the status of the patient. The unit detected

DON’T TOUCH PATIENT, CHARGING The defibrillator is charging.

RELEASE SHOCK BUTTON The Shock button was pressed while the unit was

in. Plug the cable into the unit.

Check the pads to ensure that they are properly applied to the patient, and verify that the cable is undamaged and plugged into the unit.

either a shockable rhythm or a low heart rate.

Do not touch the patient.

charging. Do not press the Shock button until the unit emits the

charge-ready tone, and the button begins flashing.

RELEASE LEFT SOFTKEY

RELEASE RIGHT SOFTKEY

A softkey was pressed for more than 10 seconds; the unit automatically switched to semiautomatic mode.

Release the softkey.

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Chapter 5

ECG Monitoring Mode

You can use the AED Pro unit for short-term monitoring of the patient’s electrocardiogram (ECG). The AED Pro unit monitors lead II only.

Rescue protocol voice prompts are disabled in ECG monitoring mode. This chapter contains the following sections:

• “About ECG Monitoring” on page 5-2

• “ECG Electrode Placement” on page 5-3

• “Applying ECG Electrodes” on page 5-4

• “Monitoring the ECG Rhythm” on page 5-6

• “Messages in ECG Monitoring Mode” on page 5-8

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide 5–1

CHAPTER 5ECG MONITORING MODE

About ECG Monitoring

For ECG monitoring, you can use

• Standard ECG electrodes (with an AED Pro ECG cable)

• AED Pro-compatible defibrillation electrode pads

The AED Pro ECG cable is an applied type CF defibrillator-proof device.

In ECG monitoring mode, the screen shows the shock count, el apsed time, mode (MONITOR), heart rate, heartbeat symbol, ECG size, ECG rhythm, and text messages.

If defibrillation electrode pads are in use, the label SEMI-AUTO appears above the right softkey.

00:24:18

MONITOR

ECG X1.0

CHECK PATIENT

SEMI-AUTO

WARNING! An implanted pacemaker might cause the heart rate meter or ECG rhythm analysis to

count the pacemaker rate during incidents of cardiac arrest or other arrhythmia.

Carefully observe pacemaker patients. Check the patient’s pulse; do not rely solely on the heart rate meter. Patient history and physical examination are important in determining the presence of an implanted pacemaker.

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ECG Electrode Placement

3-lead

configuration

(AHA)

3-lead

configuration

(IEC)

ZM048004A

ZM048003A

Before applying ECG electrodes, be sure to

• Remove all clothing covering the patient’s chest.

• Clip or shave any excessive hair to ensure proper adhesion of the electrodes.

• Use alcohol to wash away any oil or dirt at the electrode site.

• Dry any moisture at the electrode site.

Some skin abrasion is necessary to remove the top layer of dead skin cells and expose moist living cells for better electrical contact. Proper skin preparation reduces baseline wander and noise and provides a noise-free signal more quickly after electrode application.

Place ECG electrodes on the patient’s chest as shown in Table 5-1.

Table 5-1. ECG Electrode Labeling and Placement

ECG Electrode Placement

IECa Label

AHAb Label

Placement

R (red) RA (white) Patient’s right

midclavicular line, directly below clavicle.

L (yellow) LA (black) Patient’s left midclavicular

line, directly below clavicle.

F (green) LL (red) Between sixth and

seventh intercostal space on the patient’s left midclavicular line.

a. International Electrotechnical Commission b. American Heart Association

RA LA

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide 5–3

CHAPTER 5ECG MONITORING MODE

ZM040030A

ZM040031A

ZM040032A

Applying ECG Electrodes

Proper application and placement of electrodes is essential for ECG monitoring. Good contact between the electrode and the skin minimizes motion artifact and signal interference. ZOLL recommends the use of high-quality Ag/AgCl (silver/silver chloride) ECG electrodes.

Before you begin

Check the electrodes to ensure they are free from damage and are not past the expiration date on the packaging.

Procedure

To apply ECG electrodes to the patient:

Step Action

1 Identify the appropriate sites for electrode placement

(refer to “ECG Electrode Placement” on page 5-3 ).

2 Clean and abrade the patient’s skin to remove the outer

layer of dead tissue. Ensure that the skin at the electrode site is dry.

3 Snap the leads onto each electrode.

Check for good contact between the electrode and the lead termination.

4 Peel the protective backing from the ECG electrode.

Keep the adhesive surface free of electrolyte gel. WARNING! Do not use electrodes if the gel is dried or

damaged.

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Step Action

ZM040030A

5 Apply the adhesive side of each ECG electrode firmly to

the patient’s skin, pressing around the entire perimeter of the electrode.

6 Plug the ECG cable into the patient cable connector on

the unit. Note: Arrange the ECG cable so that it does not pull on

any of the electrodes.

Applying ECG Electrodes

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide 5–5

CHAPTER 5ECG MONITORING MODE

Monitoring the ECG Rhythm

You can monitor a patient’s ECG using standard ECG electrodes or defibrillation electrode pads.

Monitoring with ECG Electrodes

When it detects an AED Pro ECG cable at startup, the unit enters ECG monitoring mode (if monitoring mode is enabled) and displays the patient’s ECG rhythm and heart rate.

Procedure

To start and operate the unit in ECG monitoring mode:

Step Action Result

1 Be sure the AED Pro ECG cable is plugged

into the unit, the electrodes are snapped onto the cable, and the electrodes are attached to the patient.

2 Press and release the On/Off button to turn

on the unit.

3 Allow the unit to monitor th e patient’s ECG. If it detects a shockable rhythm while

4 If prompted, check the patient.

If prompted to plug in defibrillation cable, replace the ECG electrodes and cable with defibrillation electrode pads.

The unit starts up and the screen displays MONITOR as the current mode.

monitoring, the unit issues the voice and text prompts:

CHECK PATIENT

PLUG IN DEFIB CABLE

The latter message remains on screen until defibrillation pads are attached.

If the detected heart rate is lower than the configured minimum heart rate limit, the unit issues the voice and text prompt:

CHECK PATIENT

This message remains on screen as long as the patient’s heart rate is below the limit.

If it detects defibrillation pads, the unit changes to semiautomatic mode.

For more information, refer to Chapter 3, “Semiautomatic Mode”.

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Monitoring with Defibrillation Electrodes

00:24:18

MONITOR

SEMI-AUTO

ECG X1.0

CHECK PATIENT

With defibrillation electrodes in use, you can change from semiautomatic mode to ECG monitoring mode.

If the unit detects a shockable rhythm while in ECG monitoring mode and defibrillation electrodes are in use, the unit prompts you to check the patient and then changes to semiautomatic mode.

For more information, refer to Chapter 3, “Semiautomatic Mode”.

Before you begin

Attach defibrillation electrode pads to the patient (refer to Chapter 3.)

Procedure

To change from semiautomatic to ECG monitoring mode:

Step Action Result

Monitoring the ECG Rhythm

1 Press and hold the left (unlabele d) softkey

for at least 5 seconds.

2 Monitor the patient’s ECG. If it detects a shockable rhythm while

3 To manually return to semiautomatic mode,

press and release the SEMI-AUTO softkey.

The unit displays MONITOR as the current mode, and the SEMI-AUTO softkey label appears.

monitoring, the unit prompts you to check the patient and changes to semiautomatic mode.

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide 5–7

CHAPTER 5ECG MONITORING MODE

Messages in ECG Monitoring Mode

The following voice prompts and text messages can occur while using the unit for ECG monitoring:

Message Description

CHECK PATIENT ECG monitoring detected a shockable rhythm or low

heart rate. Evaluate the status of the patient.

PLUG IN DEFIB CABLE The unit detected a shockable rhythm while monitoring

the patient with ECG electrodes. An ECG cable was plugged in, but the unit is not

configured for ECG monitoring. Plug in the defibrillation cable.

CHECK ECG ELECTRODES Ensure that the ECG electrodes are properly attached

to the patient and that the cable is plugged into the unit.

CHECK DEFIB PADS Ensure that the defibrillation electrode pads are

properly attached to the patient and that the cable is plugged into the unit.

ATTACH DEFIB PADS TO PATIENT’S BARE CHEST

The unit does not detect attachment of the defibrillation electrode pads to the patient.

Attach defibrillation pads to the patient.

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Chapter 6

Nonrescue Mode

For the AED Pro device, Nonrescue Mode includes:

• Managing device history and clinical data

• Configuring the device

The unit includes nonvolatile memory for storing device status and clinical event information. You can retrieve stored data using a personal computer or personal digital assista nt with ZO LL RescueNet Code Review software through a USB device or an IrDA connection with the AED Pro unit.

You can configure an AED Pro device using a personal computer with ZOLL Administration Software (ZAS) through an IrDA connection with the unit.

This chapter contains the following sections:

• “Entering Nonrescue Mode” on page 6-2

• “Data Storage” on page 6-3

• “Communicating with an External Device” on page 6-4

• “Setting the Date and Time” on page 6-5

• “Device Configuration” on page 6-6

• “ZOLL Administration Software” on page 6-6

• “Messages in Nonrescue Mode” on page 6-8

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide 6–1

CHAPTER 6NONRESCUE MODE

VERSIONS

00:00:12

UNIT OK

B:01.51 L:01.67 P:02.61 H:02.00 C:02.00

USB

SET TIME

Entering Nonrescue Mode

To place the AED Pro unit in Nonrescue Mode:

Step Action Result

1 If the unit is on, press and hold the On/Off

The unit powers off.

button for 1 second to turn off the unit. Wait until the message POWERING OFF

disappears.

2 Press and hold the On/Off button for at

least 5 seconds.

The unit issues the voice and text message:

UNIT OK

If using an IrDA connection, make sure the connection is established before starting the AED Pro unit. Refer to “Setting Up Data Communications with an IrDA Connection” on page 6-4.

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Data Storage

The AED Pro unit stores device history and patient clinical data in nonvolatile memory . The unit retains the device history and clinical data even when powered off or when the battery

pack is removed. Clinical d ata is erased only when the device is powered on and electrodes are attached to a new patient. If configured to do so, the unit can store data for more than one patient.

Device History

The AED Pro unit keeps a log of its status information, including:

• Unit model name

• Device serial number

• Hardware revision number

• Application software and boot code revisi on numbe r s

• Language file version number

• Total shocks delivered

• Battery life status (percentage of charge remaining)

• Ready indicator status

• Elapsed time since installation of the battery

• Date and results of last self-test

• Error log

Data Storage

To view device history, use ZOLL Administration Software.

Patient Clinical Data

During clinical mode, the device stores the following, with date and time notation:

• Electrode attachment

• Electrode type (CPR-D•padz, CPR stat•padz, stat•padz II, or pedi•padz II defibrillation

pads, or AED Pro ECG cable)

• Results of ECG analysis

• Continuous ECG data

• Number of shocks delivered

• Energy delivered

• Patient impedance

• Voice prompts

• CPR data (depth and rate of chest co mpressions)

To view and analyze patient clinical data, use ZOLL RescueNet Code Review software.

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide 6–3

CHAPTER 6NONRESCUE MODE

VERSIONS

00:00:38

B:01.51 L:01.67 P:02.61

H:02.00 C:02.00

NEW

ALL

Communicating with an External Device

For many nonrescue operations (such as data transfer or device configuration), the AED Pro unit must establish a connection with an external device.

Setting Up Data Communications with an IrDA Connection

You can transfer data from an AED Pro unit to an external device through an IrDA (infrared wireless) connection. The AED Pro unit has an IrDA port on its right side, near the Ready indicator. The external device (such as a personal computer or personal digital assistant) must have an IrDA port as well. For IrDA adapters, refer to “Accessories” on page 1-6.

For best transmission results, the IrDA ports must be facing each other, with a clear 10- to 18-inch line-of-sight between devices.

Start the ZOLL Administration Software or RescueNet Code Review software on the computer. Press and hold the On/Off button on the AED Pro unit for at least 5 seconds to enter nonrescue mode (see page 6-2). The AED Pro unit establishes contact with the computer within 5 seconds and issues the voice and text message COMMUNICATIONS ESTABLISHED; otherw ise, it shuts down.

Downloading Data to a USB Device

You can also download patient data to a portable USB device for use with RescueNet Code Review software.

Press and hold the On/Off button on the AED Pro unit for at least 5 seconds to enter nonrescue mode (see page 6-2). Attach a USB device to the port inside the battery compartment, then press the USB softkey. The unit issues the voice and text message USB DEVICE CONNECTED.

Press the New softkey to download all new patient data since the last download. Press the All softkey to download all patient data on the unit. The unit issues the voice and text message DOWNLOADING DATA.

If there is no USB device attached, or if the unit fails to establish a connection with the USB device, the unit issues the command INSERT USB DEVICE.

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Setting the Date and Time

WARNING! Do not connect the AED Pro to a PC or other device (via the USB port) while the unit’s

electrodes are still connected to the patient.

When the AED Pro has finished downloading data, it issues the prompt DATA DOWNLOAD COMPLETE and then immediately powers off. To ensure that the unit has finished writing to

the device, wait 5 seconds or until the unit powers of f before removin g the device from the unit. You can now plug your USB device into a PC for use with the RescueNet Code Review software.

Note: While in Nonrescue Mode, the AED Pro allows you to download data to a USB device

at any time, with or without an IrDA connection established.

While in the USB menu, if no softkeys are pressed and t here is no IrDA connection established, the unit powers off after 30 seconds.

Setting the Date and Time

T o set the current date and time in the AED Pro, make sure that you are in Nonrescue Mode by holding down the On/Off button for 5 seconds (see page 6-2).

Press the SET TIME softkey. The unit then prompts you to set the year, month, day, hour, minute, and second. To advance to each subsequent screen, press the

 softkey.

• SET YEAR: Press the + softkey to advance to the desired year, using numbers 2000 through

2037. Press the

• SET MONTH: Press the + softkey to advance to the desired month, using numbers 01

 softkey to advance to the next screen.

through 12.

• SET DAY: Press the + softkey to advance to the desired day, using numbers 01 through 31.

• SET HOUR: The AED Pro has a 24-hour clock. Press the + softkey to advance to the desired

hour, using numbers 01 through 24.

• SET MINUTE: Press the + softkey to advance to the desired minute, using numbers 00

through 59.

• SET SECOND: Press the + softkey to advance to the desired second, using numbers 00

through 59.

Note: You cannot go backwards when scrolling through the numbers. If you go past the

number you want, keep pressing the + softkey until it resets to the desired number.

The unit then displays the selected date and time.To save changes, press the

 softkey. The text

message SAVING DATA appears. To cancel changes and revert to the previously set date and time, press the X softkey.

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide 6–5

CHAPTER 6NONRESCUE MODE

VERSIONS

00:00:26

2007-06-25,

B:01.51 L:01.67 P:02.61

H:02.00 C:02.00



18:02:02

While in the SET TIME menu, if no softkeys are presssed and there is no IrDA connection established, the unit powers off after 30 seconds.

Device Configuration

The AED Pro unit provides configurable settings to suit the needs of your organization and its medical protocols. Before putting the unit into service for the first time, the administrator should inspect the factory settings and make any required adjust ments.

Operators cannot adjust these settings while the unit is in clinical use. For more information, refer to Appendix C, “Configurable Settings.”

ZOLL Administration Software

ZOLL Administration Software (ZAS) helps you perform software maintenance tasks when the AED Pro unit is communicating with a personal computer. Using ZAS, you can transfer data from the AED Pro unit to a computer. From the computer, you can transmit the data to a network or print the data to a local printer.

For instructions on using ZAS, refer to its online help.

Installing ZOLL Administration Software

T o i nstall ZOLL Admi nistration Softwa re, inse rt the ZOLL Ad ministration Softwa re CD into a CD-ROM drive on the computer. The installation program starts automatically.

If the installation program does not start, do the following:

1. From the Windows Start menu, select Run.

2. In the Open field, type

3. Click OK.

Follow the on-screen instructions to complete the installation.

x:setup.exe (where x is the letter of the CD-ROM drive that contains the ZAS CD).

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RescueNet Code Review Software

T o anal yze incident i nformation transferred from the AED Pro unit to a personal computer , use RescueNet Code Review software. With this software, you can

• Transfer patient data from the AED Pro unit to a personal computer

• Access and review patient case data

• Add or modify patient information

• View an animated ECG

• Annotate the ECG

• Print ECG stripcharts and case reports

For more information, refer to the RescueNet Code Review User’s Guide.

ZOLL Administration Software

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide 6–7

CHAPTER 6NONRESCUE MODE

Messages in Nonrescue Mode

The unit can display the following messages when exchanging data:

Message Description

COMMUNICATIONS ESTABLISHED

DATA DOWNLOAD COMPLETE Data transfer was successful. DATA DOWNLOAD FAILED Data transfer halted because th e external device detected

NON-RESCUE MODE The unit is operating in nonrescue mode and connected to

USB DEVICE CONNECTED The unit recognizes that an external USB device has been

USB DEVICE FULL The attached USB device is full, and cannot receive data. INSERT USB DEVICE Prompts you to insert a USB device into the USB port

NO DATA There is no new patient data to download to the USB device.

The unit successfully contacted an external IrDA device.

an error or the operator canceled transmission through the communication program.

Check the communications p ackage or utility on the external device for the source of the error.

an external IrDA device.

connected.

located inside the battery compartment.

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Chapter 7

T roubleshooting and

Maintenance

To ensure that the AED Pro unit is functioning properly and is ready for use in an emergency, general maintenance procedures should be performed before putting the unit in to service and after each clinical use.

This chapter contains the following sections:

• “General Troubleshooting” on page 7-2

• “ECG Monitoring Trou bl esho oting” on page 7-4

• “Defibrillator Troubleshooting” on page 7-5

• “Cleaning the Unit” on page 7-6

• “Optional Maintenance for Technical Professionals” on page 7-7

If trouble persists after consulting this chapter, contact the appropriate technical personnel or ZOLL Technical Service Department.

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide 7–1

CHAPTER 7TROUBLESHOOTING AND MAINTENANCE

General Troubleshooting

Table 7-1 lists general issues with the unit and their associated corrective action.

Table 7-1. General Issues

Symptom Corrective Action

Unit beeps or displays a red “X” while turned off.

Ready indicator shows a red “X” while the device is powered on.

Power-on self-test failed. F ollow the prompts to resolve the problem.

Unexpected shutdown in clinical mode. Note: In clinical mode, the unit automatically powers

Unexpected shutdown in nonrescue mode.

Turn the unit on. Follow the prompts to resolve the problem.

If the unit continues to fail, take it out of service, and contact ZOLL Technical Service.

Turn the unit off and then on again. Follow the prompts to resolve the problem.

If the unit continues to fail, take it out of service, and contact ZOLL Technical Service.

off if it does not detect a patient connection within 10 minutes (configurable).

Turn the unit on. Follow the prompts to resolve the problem.

If the unit continues to fail, take it out of service, and contact ZOLL Technical Service.

Note: The unit automatically powers off if an

established IrDA connection is lost.

Press and hold the On/Off button for at least 5 seconds. Follow the prompts to resolve the problem.

If the unit still is not ready for use, take it out of service. Contact ZOLL Technical Service.

Message:

CHANGE BATTERY

Message:

PLUG IN CABLE

Message:

RELEASE SHOCK BUTTON

Replace the battery pack with a fully charged battery pack as soon as possible.

Ensure that the electrode cable is properly connected to the unit.

Remove the cable and check for bent or broken pins. Replace the electrode cable.

Release the Shock button. Wait until the unit issues the prompt PRESS FLASHING SHOCK BUTTON before pressing the button.

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Table 7-1. General Issues (continued)

Symptom Corrective Action

General Troubleshooting

Message:

PLUG IN DEFIB CABLE

Message:

RELEASE LEFT SOFTKEY

RELEASE RIGHT SOFTKEY

Note: This prompt appears if an ECG cable is

connected, but the unit is not configured for ECG monitoring.

Check the cable, and replace if necessary. A softkey was pressed for more than 10 seconds; the

unit automatically switched to semiautomatic mode. Release the softkey.

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide 7–3

CHAPTER 7TROUBLESHOOTING AND MAINTENANCE

ECG Monitoring T roubleshooting

Table 7-2 lists common issues with ECG monitoring and their associated corrective action.

Table 7-2. ECG Monitoring Issues

Symptom Corrective Action

Messages:

CHECK ECG ELECTRODES ATTACH ECG ELECTRODES

Noisy ECG, artifact, or wandering baseline.

Poor ECG signal level. Replace the ECG electrodes, and change their

Irregular heart rate. Observe the patient’s ECG. Verify that the irregular

Ensure that the ECG cable is connected to each electrode and to the unit.

Ensure that the ECG electrodes are making good contact with the patient and are not dried out.

Replace the ECG electrodes. Replace the ECG cable.

Turn off nearby two-way radios and cell phones. Before attaching electrodes, properly prepare the

patient’s skin (refer to “Applying ECG Electrodes” on page 5-4).

Check for proper adhesion of the electrodes to the patient.

Arrange the cable and leads so that they do not pull on the electrodes or swing excessively.

position on the patient.

heart rate is not caused by noise, low amplitude R waves, extra-systoles, or arrhythmias.

Replace the ECG electrodes, and change their position on the patient.

Message:

PLUG IN DEFIB CABLE

ECG data recording stops. If the unit is turned off and then turned on again within

ECG analysis detected a shockable rhythm. Replace the ECG electrodes and cable with

defibrillation pads to deliver therapy.

10 seconds, ECG recording is interrupted.

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Defibrillator T roubleshooting

Table 7-3 lists common issues with defibrillation and their associated corrective action.

Table 7-3. Defibrillator Issues

Symptom Corrective Action

Defibrillator does not charge. The patient’s ECG rhythm is not shockable because it

Defibrillator Troubleshooting

is not either ventricular fibrillation (VF) or wide complex ventricular tachycardia (VT), or is VF with amplitude less than 100 V (semiautomatic mode only). Verify the rhythm.

Confirm that the defibrillation cable is plugged in and the pads are attached to the patient.

Install a fully charged battery pack.

Defibrillator takes more than 15 seconds to charge.

Energy does not discharge when the Shock button is pressed.

No apparent energy delivery to patient. Under certain circumstances, a patient might not

Message:

CHECK DEFIB PADS

Install a fully charged battery pack.

A fully charged defibrillator automatically disarms itself after 60 seconds in manual mode or 30 seconds in semiautomatic mode. Charge the defibrillator again, and deliver the shock while the charge-ready tone sounds.

The Shock button was pressed before the unit was fully charged. Wait for the charge-ready tone and a flashing Shock button before pressing and holding the Shock button.

display a physical reaction when energy is delivered. Replace the electrodes if they are dried out or expired. Ensure that the electrodes are making proper contact

with the patient’s skin. Test the defibrillator. (Refer to “Optional Maintenance

for Technical Professionals” on page 7-7.) If the message CHECK DEFIB PADS appears, check

and correct the attachment or position of the electrodes.

Ensure that the defibrillation electrode pads are making proper skin contact and that patient does not have excessive hair beneath electrodes.

If message persists, change the defibrillation cable.

Message:

ANALYSIS HALTED. KEEP PATIENT STILL.

Message:

DEFIB MAINTENANCE REQUIRED

Check for proper application and adhesion of the defibrillation electrode pads.

Ensure that no one is touching the patient and that the patient is motionless during ECG analysis.

Contact ZOLL Technical Service.

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide 7–5

CHAPTER 7TROUBLESHOOTING AND MAINTENANCE

Cleaning the Unit

After each use, clean and disinfect the unit and ECG cables with a soft, damp cloth using any of the following cleaning agents:

• Soap and water

• Chlorine bleach solution (30 milliliters per liter of water)

• 90% isopropyl alcohol

The AED Pro unit and its accessories are chemically resistant to most common cleaning solutions and noncaustic detergents.

Refer to the “Cautions” on page x.

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Optional Maintenance for Technical Professionals

The AED Pro is calibrated at the factory and requires no testing other than the self-tests it performs. Qualified professionals who want to perform additional tests can use the following procedure.

Required equipment

• AED Pro simulator (or equivalent)

Before you begin

Be sure the unit and the simulator/tester are turned off.

Procedure

To test the unit:

Step Action

1 Connect the AED Pro simulator to the unit’s patient cable connector. 2 Power on the simulator and the AED Pro unit. 3 Verify that all of the following occur:

• The Ready indicator initially displays a red “X”, which changes to a green check within 10 seconds after the unit is turned on.

• The unit issues the voice and text message UNIT OK within 10 seconds (if configured).

• The screen displays the shock count and the elapsed time.

4 Set the simulator to send a VF rhythm to the AED Pro unit. 5 After the sequence of patient assessment prom pts, verify that the unit does the following:

• Issues the voice and text prompt DON’T TOUCH PATIENT, ANALYZING.

• Analyzes the ECG rhythm.

• Issues the voice and text message SHOCK ADVISED.

• Charges the defibrillator.

• Issues the voice and text prompts DON’T TOUCH PATIENT and PRESS FLASHING

SHOCK BUTTON.

6 Verify that the AED Pro unit sounds the charge-ready tone and that the Shock button

flashes repeatedly.

7 Press the Shock button. Verify that the simulator indicates that a shock was delivered and

that the unit updates the displayed shock count. Note: The simulator can verify the unit’s ability to deliver energy but cannot verify that the

correct energy was delivered. To verify the level of delivered energy, use a defibrillator analyzer and universal adapter cable in place of the simulator.

8 Immediately after shock delivery, change the simulator to send a normal sinus rhythm

(NSR) to the AED Pro unit.

9 Verify that the AED Pro unit performs a new rhythm analysis, resulting in the message NO

SHOCK ADVISED, followed by the voice and text prompt: START CPR

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CHAPTER 7TROUBLESHOOTING AND MAINTENANCE

Step Action

10 Activate the simulator’s CPR function. 11 Verify that the metronome begins to beep.

Verify that the AED Pro unit issues the following voice and text prompts within 60 seconds (unless CPR monitoring is disabled on the unit):

PUSH HARDER GOOD COMPRESSIONS

Verify that the chest compression gauge functions properly.

12 After approximately 2 minutes of CPR, verify that the unit issues the voice and text prompt

STOP CPR.

13 Verify that the AED Pro unit begins a new ECG analysis. 14 Turn off the AED Pro unit and the simulator. 15 Verify that the Ready indicator displays a green check before disconnecting the simulator

and attaching defibrillation electrode pads.

For instructions on placing the unit back into service, refer to “Preparing the Unit for Clinical Use” on page 2-5.

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Appendix A

S pecifications

This appendix describes the specifications for the AED Pro unit and contains the following sections:

• “Device Specifications” on page A-2

• “Battery Pack Specifications” on page A-5

• “Guidance and Manufacturer’s Declaration — Electromagnetic Emissions” on page A-6

• “Rectilinear Biphasic Waveform Characteristics” on page A-10

• “Clinical Trial Results for the M Series Biphasic Waveform” on page A-13

• “ECG Analysis Algorithm Accuracy” on page A-15

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide A–1

APPENDIX ASPECIFICATIONS

Device Specifications

General

Size (height • width • length)

Weight 5.19 lb. (2.35 kg) without battery pack

Power Battery pack

Device classification Class II and internally powered per EN 60601-1

Design standards Meets applicable requirements of UL 2601, AAMI DF80,

Patient safety All patient connections are electrically isolated.

Environmental

Temperature Operating: 0°C to 50°C

Humidity 10% to 95% relative humidity, noncondensing

3 in • 9.24 in • 9.4 in

7.62 cm • 23.47 cm • 23.88 cm

5.97 lb. (2.70 kg) with nonrechargeable battery pack

IEC 60601-2-4, EN 60601-1, IEC 60601-1-2

Storage and shipping: –30°C to 70°C

Vibration MIL-STD-810F, Integrity Test for Helicopters

Shock IEC 60068-2-27; 100G

Altitude Height: –300 to 15,000 ft; –91 to 4573 m

Pressure: 768 to 429 mmHg; 1024 to 572 millibars

Particle and water ingress

Drop test 1.5 m per IEC 68-2-32

Defibrillator

Waveform ZOLL Rectilinear Biphasic waveform

Energy selection Configurable preset energy levels for adult and pediatric patients in

Charge time Less than 10 seconds with a new, fully charged battery; with depleted

Charge hold time Semiautomatic mode: 30 seconds

Energy display Display screen shows selected energy level (manual mode only).

IEC 60529, IP 55

three-shock stacks.

battery packs, the charge time is longer. For the fifteenth discharge at maximum energy (200 joules), the

charge time is less than 10 seconds.

Manual mode: 60 seconds

Charge controls Semiautomatic mode: Automated

Manual mode: Softkey

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Device Specifications

Defibrillation electrode pads

Built-in defibrillator self-test

Defibrillation advisory Evaluates electrode attachment and patient ECG to determine if

Valid p atient impedance range

CPR Monitoring

Compression depth 0.75 to 3 inches ±0.25 inches

Compression rate 50 to 150 compressions per minute

ECG Monitoring

Input protection Fully defibrillation-protected

ZOLL single-use, pre-gelled electrode pads:

• CPR-D•padz (includes CPR sensor)

• CPR stat•padz (includes CPR sensor)

• Adult stat•padz II

• Pediatric pedi•padz II

Verifies proper charging and discharging of the defibrillator.

defibrillation is needed. Shockable arrhythmia:

• Ventricular fibrillation (VF) with amplitude greater than 100 V

• Wide-complex ventricular tachycardia (VT)

Adult: greater than 150 beats per minute Pediatric: greater than 200 beats per minute

10 to 300

1.9 to 7.6 cm ±0.6 cm

Bandwidth 1.4 to 22 Hz with defibrillation electrode cable

1.4 to 22 Hz (default) with AED Pro ECG cable;

0.7 to 30 Hz as a configurable option

ECG lead Lead II

ECG amplitude range ±5 mV

Heart rate range 30 to 300 beats per minute

Heart rate accuracy ±5 beats per minute

Heart rate resolution 1 beat per minute

Heart rate alert

Heart rate alarm Voice and text prompt indicates activated/deactivated status.

Tall T-wave rejection 9 mm

• Configurable low heart rate limit in the range 30 to 100 beats per minute

• Off

Tachycardia: 250 bpm Bradycardia: 30 bpm - 100 bpm, user selectable

0.9 mV

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide A–3

APPENDIX ASPECIFICATIONS

Heart rate averaging The AED Pro averages the interval between the last 5 detected beats.

Accuracy and response time to irregular rhythm

Response time to change in heart rate

Time to alarm for tachycardia

Data Recording an d Storage

Type Nonvolatile memory Capacity 5.8 hours of ECG data and CPR data

Display Screen

Display type Liquid crystal display (LCD)

Viewable area (height • width)

Sweep speed 25 mm/s ±5% Viewing time 2.96 seconds (if CPR gauge displayed)

On startup, the AED Pro averages the rate between detected beats once two beats are detected, until a full 5 beats have been received. The rate is updated every beat. After this condition is met, the meter is updated every beat with an average of the last 5 beats.

If a period of time greater than 5 seconds elapses without a beat detected, the heart rate meter reports a rate of 0 bpm, which is repeated every 5 seconds.

Averaging over 5 R-R intervals, per AAMI EC 13:2002 (R2007):

• Ventricular Bigeminy (Figure A1) - 40 bpm

• Slow alternating ventricular bigeminy (Figure A2) - 55-65 bpm

• Rapid alternating ventricular bigeminy (Figure A3) - 59-60 bpm

• Bidirectional systoles (Figure A4) - 59-60 bpm

80 to 120 bpm: 4 seconds 80 to 40 bpm: 4 seconds

(Figure B1) 206 bpm (1 mV): 7.88 seconds

206 bpm (halved amplitude): 8.72 seconds 206 bpm (doubled amplitude): 8.15 seconds

(Figure B2) 195 bpm (2 mV): 7.94 seconds

195 bpm (halved amplitude): 7.10 seconds 195 bpm (doubled amplitude): 7.97 seconds

20 minutes of audio recording and ECG data if Audio Recording Option is enabled

High resolution, 320 pixels by 240 pixels

2.27 in • 3.02 in

5.76 cm • 7.68 cm

3.2 seconds (without CPR gauge)

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Battery Pack Specifications

Type Sealed lead acid

Weight 1 kg

2.2 lb.

Nominal voltage 10 V

Battery Pack Specifications

Rechargeable Sealed Lead Acid

Recharge time 4 hours or less with:

ZOLL Base PowerCharger ZOLL Base PowerCharger ZOLL SurePower Charger Station

Operating time For a new, fully charged battery pack at 20°C:

170 defibrillator discharges at maximum energy (200 joules) or 6 hours of continuous ECG monitoring.

The CHANGE BA TTER Y warning appears after 115 maximum-energy discharges.

Standby life 3 months befo re recharge or retest

Disposable Sealed Lithium Manganese Dioxide

Type Disposable sealed lithium manganese dioxide

Weight 0.4 kg

0.9 lb.

Nominal voltage 12 V

Operating time For a new, fully charged battery pack at 20°C:

300 defibrillator discharges at maximum energy (200 joules) or 15 hours of continuous ECG monitoring.

The CHANGE BATTERY warning appears after 200 maximum- energy discharges.

Standby life 5 years

4x4 1x1

Rechargeable Lithium Ion (SurePower Battery Pack)

Type Rechargeable lithium ion

Weight 0.77 kg

1.7 lb.

Nominal voltage 10.8 V

Recharge time 4 hours or less with SurePowe r Charger Station Operating time For a new, fully charged battery pack at 20°C:

400 defibrillator discharges at maximum energy (200 joules) or 19 hours of continuous ECG monitoring.

The CHANGE BATTERY warning appears after 300 maximum- energy discharges.

Standby life 3 months befo re recharge or retest.

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide A–5

APPENDIX ASPECIFICATIONS

Guidance and Manufacturer’s Declaration — Electromagnetic Emissions

The ZOLL AED Pro device is intended for use in the electromagnetic environment specified below. The customer or operator should ensure that the device is used in such an environment.

Table A-1. EMC Specifications

Emissions Test Compliance

RF emissions CISPR 11

Harmonic emission IEC 61000-3-2 Voltage fluctuations/

flicker emission IEC 61000-3-3 Medical electrical equipment needs special precautions regarding EMC and needs to be

installed and put into service according to EMC information provided in this document.

Group 1 The ZOLL AED Pro unit uses RF energy

Class B

Not applicable

Electromagnetic Environment –

Guidance

for its internal function only. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

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Guidance and Manufacturer’s Declaration — Electromagnetic Emissions

Electromagnetic Immunity Declaration (EID)

The ZOLL AED Pro device is intended for use in the electromagnetic environment specified below. The customer or operator should ensure that the device is used in such an environment.

Immunity Test

Electrostatic discharge (ESD)

IEC 61000-4-2 Electrical fast

transient/burst IEC 61000-4-4

Surge IEC 61000-4-5

Voltage dips, short interruptions, and voltage variations on power supply input lines

IEC 61000-4-11

Power frequency (50/60 Hz) magnetic field

IEC 61000-4-8

IEC 60601

Test Level

±6 kV contact

±8 kV air

±2 kV for power supply lines

±1 kV for input/output lines

±1 kV differential mode ±2 kV for common

mode <5% Ut (>95% dip in

Ut) for 0.5 cycle 40% Ut (60% dip in Ut)

for 5 cycles 70% Ut (30% dip in Ut)

for 25 cycles <5% Ut (>95% dip in

Ut) for 5 seconds Note: Ut is the ac

mains voltage prior to application of the test level.

3 A/m 3 A/m Power frequency magnetic fields

Compliance

Level

±6 kV contact

±8 kV air

Not applicable

±1 kV I/O

Not applicable Not applicable

Not applicable

Electromagnetic Environment –

Guidance

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

should be at levels characteristic of a typical location in a typical commercial or hospital environment.

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide A–7

APPENDIX ASPECIFICATIONS

PPP

P

Immunity Test

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

IEC 60601

T est Level

3 Vrms 150 kHz to 80 MHz outside ISM bands

10 Vrms 150 kHz to 80 MHz in ISM bands

10 V/m 80 MHz to 2.5 GHz

Compliance

3 Vrms

10 Vrms

10 V/m

Level

Electromagnetic Environment –

Guidance

Portable and mobile RF communications equipment should be used no closer to any part of the

AED Pro

device, including cables, than

the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance (d)

in meters

d = 1.17 outside ISM bands d = 1.20 within ISM bands

d = 1.20 80 MHz to 800 MHz d = 2.30 800 MHz to 2.5 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

Field strengths from fixed RF transmitters, as determined by an

electromagnetic site survey

, should be

less than the compliance level in each

frequency range

Interference may occur in the vicinity of equipment marked with the following symbol:

Notes (1) At 80 MHz and 800 MHz, the higher frequency range applies.

(2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and pe ople.

a. The ISM (industrial, scientific, and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to

6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.

b. The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency

range 80 MHz to 2.5 GHz are intended to decrease the likelihood that mobile or portable communications equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in these frequency ranges.

c. Field strengths from fixed transmitters, such as base stations for radio (cellular or cordless) telephones and

land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the AED Pro unit is used exceeds the applicable RF compliance level above, the AED Pro unit should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the AED Pro unit.

d. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

A–8 www.zoll.com 9650-0350-01 Rev. G

Guidance and Manufacturer’s Declaration — Electromagnetic Emissions

d =

P

3.5 3

[

]

d =

P

12 10

[

]

d =

P

12 10

[

]

d =

P

[

]

Recommended separation distances between portable and mobile RF communications equipment and the AED Pro unit

The AED Pro unit is intended for use in an environment in which radiated RF disturbances are controlled. The customer or operator can help prevent electromag netic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the AED Pro unit as recommended below, according to the maximum output power of the communications equipment.

Separation distance in meters (m) according to frequency of transmitter

Rated maximum

output power of

transmitter in watts

(W)

150 kHz to 80 MHz

outside ISM bands

0.01 0.17 0.12 0.12 0.23

0.1 0.370.380.380.73 1 1.171.201.20 2.3

10 3.69 3.79 3.79 7.27

100 11.70 12.00 12.00 23.00

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters can be determined using the equation applicable to the frequency of the transmitter, where

P is the maximum output power rating of the transmitter in watts according to

the transmitter manufacturer. Notes (1) At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. (2) The ISM (industrial, scientific, and medical) bands between 150 kHz and 80 MHz are

6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and

40.66 MHz to 40.70 MHz. (3) An additional factor of 10/3 is used in calculating the recommended separation distance for

transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz to decrease the likelihood that mobile or portable communications equipment could cause interference if it is inadvertently brought into patient areas.

(4) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

150 kHz to 80 MHz

in ISM bands

80 MHz to

800 MHz

800 MHz to

2.5 GHz

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide A–9

APPENDIX ASPECIFICATIONS

Rectilinear Biphasic Waveform Characteristics

The following table shows the characteristics of the Rectilinear Biphasic waveform when discharged into 25 ohm, 50 ohm, 100 ohm, and 125 ohm loads at the maximum energy setting of 200 joules.

Table A-2. Rectilinear Biphasic Waveform Characteristics

200 J discharged into

25 50 100 125

First phase

Maximum initial current 32 A 26 A 21 A 17 A Average current 28 A 22 A 16 A 13 A Duration 6 ms 6 ms 6 ms 6 ms

Interphase duration (between first and second phases)

Second phase

Initial current 33 A 19 A 12 A 11 A Average current 21 A 14 A 11 A 10 A Duration 4 ms 4 ms 4 ms 4 ms

Table A-3. Delivered Energy at Each Defibrillator Setting into a Range of Loads

Load

25 40 J 61 J 66 J 95 J 111 J 146 J 50 51 J 80 J 85 J 124 J 144 J 183 J

75 64 J 89 J 111 J 148 J 172 J 204 J 100 62 J 86 J 108 J 147 J 171 J 201 J 125 63 J 89 J 110 J 137 J 160 J 184 J 150 67 J 93 J 116 J 127 J 148 J 168 J 175 61 J 86 J 107 J 119 J 138 J 155 J

Accuracy ±15% ±15% ±15% ±15% ±15% ±15%

50 J 70 J 85 J 12 0 J 150 J 200 J

200 s 200 s 200 s 200 s

Selected Energy

The AED Pro Rectilinear Biphasic waveform employs the same first and second phase timing, similar first and second phase currents/voltages, and essentially the same mechanisms for controlling defibrillation waveshape as the ZOLL M Series®. The ZOLL M Series and AED Pro defibrillation waveforms are considered substantially equivalent.

Figures A-1 through A-6 show the Rectilinear Bip hasic w avefo rms that are p rod uced wh en the AED Pro defibrillator is discharged into loads of 25, 50, 75, 100, 125, 150, and 175 o hms at each energy setting (200, 150, 120, 85, 70, and 50 joules).

The vertical axis shows the current in amperes (A); the horizontal axis shows the duration in milliseconds (ms).

A–10 www.zoll.com 9650-0350-01 Rev. G

Rectilinear Biphasic Waveform Characteristics

-30

-25

-20

-15

-10

-5

0246 8101214161820

-25

-20

-15

-10

-5

0246 8101214161820

25Ω

50Ω

75Ω

100Ω

125Ω

150Ω

175Ω

-20

-15

-10

-5

0246 8101214161820

Figure A-1. Rectilinear Biphasic Waveforms at 200 Joules

100Ω

125Ω

150Ω

175Ω

25Ω

50Ω

75Ω

Figure A-2. Rectilinear Biphasic Waveforms at 150 Joules

9650-0350-01 Rev. G ZOLL AED Pro Operator’s Guide A–11

Figure A-3. Rectilinear Biphasic Waveforms at 120 Joules

25Ω

50Ω

75Ω

100Ω

125Ω

150Ω

175Ω

APPENDIX ASPECIFICATIONS

-20

-15

-10

-5

0246 8101214161820

-20

-15

-10

-5

0246 8101214161820

-15

-10

-5

0246 8101214161820

25Ω

50Ω

75Ω

100Ω

125Ω

150Ω

175Ω

Figure A-4. Rectilinear Biphasic Waveforms at 85 Joules

25Ω

50Ω

75Ω

100Ω

125Ω

150Ω

175Ω

25Ω

50Ω

75Ω

100Ω

125Ω

150Ω

175Ω

Figure A-5. Rectilinear Biphasic Waveforms at 70 Joules

A–12 www.zoll.com 9650-0350-01 Rev. G

Figure A-6. Rectilinear Biphasic Waveforms at 50 Joules

Zoll AED Pro User manual

Specifications and Main Features

Frequently Asked Questions

User Manual