AED Pro and Pro A-W Operators Guide Rev L

The issue date for the AED Pro Operator’s Guide (REF 9650-0350-01 Rev. L) is June, 2019. If more than 3 years have elapsed since the issue date, contact ZOLL Medical Corporation to determine if additional product information updates are available. Copyright © 2019 ZOLL Medical Corporation. All rights reserved. AED Plus, AED Pro, CPR-D-padz, M Series, Pedi-padz, PowerCharger, Real CPR Help, Rectilinear Biphasic, RescueNet, See-Thru CPR, Stat-padz, SurePower and ZOLL are trademarks or registered trademarks of ZOLL Medical Corporation in the United States and/or other countries. All other trademarks and registered trademarks are property of their respective owners. Caution: Federal law restricts this device to sale by or on the order of a licensed practitioner.

Indication of use

Indication of use The AED Pro system is indicated for use 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.

The device is also indicated for use when ECG monitoring is indicated to evaluate the patient’s heart rate or ECG morphology. The AED Pro system is indicated for adult and pediatric patients.

Contraindication of use Never use the unit for defibrillation when the patient • Is conscious • Is breathing, or • Has a detectable pulse or other sign of circulation.

General Information Federal (U.S.A.) law restricts this defibrillator to sale by or on the order of a physician.

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Table of Contents Indication of use... iii Contraindication of use ... iii General Information ... iii

Chapter 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

Chapter 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-padz II ... 3-8

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TABLE OF CONTENTS Semiautomatic Defibrillation ... 3-9 Start with CPR Option ... 3-12 Messages in Semiautomatic Mode ... 3-12

Chapter 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

Chapter 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

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Appendix A

Specifications

Device Specifications...A-2 Battery Pack Specifications ...A-6 Guidance and Manufacturer’s Declaration - Electromagnetic Compatibility...A-7 Electromagnetic Immunity Declaration (EID) ...A-8 Rectilinear Biphasic Waveform Characteristics ...A-12 Clinical Trial Results for the M Series Biphasic Waveform ...A-15 Randomized Multicenter Clinical Trial for Defibrillation of Ventricular Fibrillation (VF) and Ventricular Tachycardia (VT) ...A-15 Pre-Clinical Study ...A-16 Published Clinical Data ...A-17 ECG Analysis Algorithm Accuracy ...A-18

Appendix 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

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

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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 x “Safety Considerations” on page xi “Equipment” on page xv “Intended Use” on page xx

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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 update in its appropriate 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

ZOLL Base PowerCharger 4x4 Operator’s Manual

9650-0120-01

ZOLL Base PowerCharger 1x1 Operator’s Manual

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).

WARNING!

Warning statements alert you to conditions or actions that can result in personal injury or death.

Caution

Caution statements alert you to conditions or actions that can result in damage to the unit.

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Safety Considerations

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. There are no replaceable parts in this unit without the use of tools, and no user replaceable parts while the unit is in clinical operation on a patient. 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 joules. 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.

General 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 likelihood 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. MR Unsafe: Keep the AED Pro defibrillator away from magnetic resonance imaging (MRI) equipment. Do not use or place the unit in service if it beeps while turned off. 9650-0350-01 Rev. L

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PREFACE 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. Do not use or place the unit in service if the Ready indicator (at the upper right 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 disconnect from the patient all electromedical equipment that is not defibrillation-protected. Keep 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 patient 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. Disconnect the AED Pro from the patient before performing defibrillation with another defibrillator. If the AED Pro shuts down or malfunctions during defibrillation of the patient with a different defibrillator, turn the AED Pro unit off and then back on, and continue normal use. 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.

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PREFACE 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 monitoring only; you cannot use ECG electrodes for defibrillation.

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 operation as follows 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

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 shipping. 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 indicated by a red “X” in the Ready indicator after battery installation), contact 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 Dangerous voltage.

MR unsafe: keep away from magnetic resonance imaging equipment

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.

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PREFACE Symbol

Description

Defibrillator-proof type BF equipment.

Defibrillator-proof type CF equipment.

,%!

2. 45

$

2%

Contains lead. Recycle or dispose of properly.

2%#9#,%

IO

RN

TU

Li-

RE

N

0B

Contains lithium. Recycle or dispose of properly.

RECYCLE

Li-ION

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.

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Equipment Symbol

Description Do not reuse.

Do not fold.

Not sterile.

Nonionizing electromagnetic radiation.

Manufacturer.

Authorized representative in the European Community.

Serial Number.

Catalogue number.

Consult instructions for use.

Prescription only.

Return to a collection site intended for waste electrical and electronic equipment (WEEE). Do not dispose of in unsorted trash.

Class II equipment.

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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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Equipment

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. 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. s

For customers

In the U.S.A.

Return the unit to ZOLL Medical Corporation 269 Mill Road Chelmsford, MA 01824-4105 Attention: Technical Service Department (SR number) Telephone: 1-800-348-9011

In Canada

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

In other locations

ZOLL Medical Corporation 269 Mill Road Chelmsford, MA 01824-4105 Telephone: 1-978-421-9655

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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 at least 2 inches (5 cm) for adult patients.

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 training.

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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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

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CHAPTER 1 PRODUCT 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 appropriate 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

These energies will be delivered by the AED Pro into a 50Ω patient load. 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 analyzing 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® or CPR Stat-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. For more information, refer to Chapter 3, “Semiautomatic Mode”. 1–2

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