ZOLL AED Plus Administrator's Manual
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ZOLL AED Plus Administrator's Manual

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AED Plus
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Administrator's Guide
9650-0301-01 Rev. YA

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  • Page 1 AED Plus ® Administrator’s Guide 9650-0301-01 Rev. YA...
  • Page 2 This issue date for the ZOLL AED Plus Administrator’s Guide, (REF 9650-0301-01 Rev YA) is May, 2017. Copyright © 2017 ZOLL Medical Corporation. All rights reserved. AED Plus, AED Pro, CPR-D-padz, M Series, Pedi-padz, Real CPR Help, Rectilinear Biphasic, RescueNet, Stat-padz and ZOLL are trademarks or registered trademarks of ZOLL Medical Corporation in the United States and/or other countries.

  • Page 3: Table Of Contents

    Using Real CPR Help ....................................2 ......................................3 PERATION Operating Controls and Indicators................................3 Using the AED Plus Graphical User Interface.............................5 Voice Prompts ......................................6 Using the LCD Display .....................................9 Using the Passive Airway Support System (PASS) .......................... 10 Using Electrodes...................................... 11 Applying CPR-D-padz .................................... 12 Applying Pedi-padz II (Infant/Child Electrodes)..........................
  • Page 4 Clinical Trial Results for the M Series Biphasic Waveform......................40 Randomized Multi-Center Clinical Trial for Defibrillation of Ventricular Fibrillation (VF) and Ventricular Tachycardia (VT) ..40 Pre-Clinical Study ........................................41 Published Clinical Data ....................................... 42 ECG Analysis Algorithm Accuracy..............................43 ZOLL AED PLUS Administrator’s Guide...

  • Page 5: Preface

    Introduction- Provides a general product overview of the AED Plus. Section 1 - Operation - Describes the functions of all controls and indicator lights of the AED Plus. Section 2 - Installation, Self Test, Maintenance and Troubleshooting- Describes configuration of the unit, data communications, troubleshooting, maintenance and how to order accessories and supplies.

  • Page 6: Safety Summary

    • DO NOT recharge, disassemble, or dispose of batteries in fire. Batteries may explode, if mistreated. • Do not use or stack the AED Plus unit with other equipment. If the unit is used or stacked with other equipment, verify proper operation prior to use.

  • Page 7: Cautions

    When the victim is less than 8 years of age, or weighs less than 55 lbs (25 kg), the ZOLL AED Plus should be used with the ZOLL AED Plus Pediatric Electrodes. Therapy should not be delayed to determine the victim’s exact age or weight.

  • Page 8: Tracking Requirements

    U.S Federal Law (21 CFR 821) requires the tracking of defibrillators. As an owner of this device, you have the responsibility under this law to notify ZOLL Medical Corporation if this product has been received, lost, stolen or destroyed or has been donated, resold or otherwise distributed to a different organization.

  • Page 9: Symbols

    Unit equipped to treat adult and pediatric victims Manufacturer Return to a collection site intended for waste electrical and electronic equipment (WEEE). Do not dispose of in unsorted trash. Authorized representative in the European Community ZOLL AED PLUS Administrator’s Guide...
  • Page 10 Serial Number Catalogue number Consult instructions for use Prescription only. ZOLL AED PLUS Administrator’s Guide...

  • Page 11: Introduction

    CPR for a period of 2 minutes, after which the unit automatically initiates a new ECG analysis. The AED Plus has an optional cover that can be used as a PASS (Passive Airway Support System) to support the victim’s neck and shoulders in a position that assists in maintaining an open airway. Some versions also contain disposable accessories (razor, barrier mask, scissors, and a towel).

  • Page 12: Using Real Cpr Help

    CPR compressions, the sensor detects their rate and depth and sends the information to the AED Plus unit. When used with CPR-D-padz, the AED Plus monitors the depth and rate of CPR chest compressions. It provides a CPR metronome function designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute (CPM) as well as voice and visual prompts to encourage a minimum compression depth of 2 inches for adult victims.

  • Page 13: Operation

    Operation This section describes the following functions: • Operating Controls and Indicators • Using the AED Plus Graphical User Interface • Voice Prompts • Using the LCD Display • Using the Passive Airway Support System (PASS) • Using Electrodes • Applying CPR-D padz ®...
  • Page 14 Illuminates to indicate which step rescuer must take to treat a victim. Shock Button Illuminates when the AED Plus is charged and ready to deliver a shock to the victim. When pressed, causes the charged and ready AED Plus to discharge its energy into the victim.

  • Page 15: Using The Aed Plus Graphical User Interface

    Using the AED Plus Graphical User Interface The AED Plus graphical user interface (see Figure 2) is visible on the top of the unit when the cover is removed. The pictograms are reminders of the steps to follow when performing a rescue and reinforce instructions provided through voice prompts and optional display messages.

  • Page 16: Voice Prompts

    Consult the AED Plus Operator’s Guide for more details on the graphics included in the unit’s graphic interface, the audio prompts issued at each step in the treatment protocol and the rescuer action associated with these audio and visual prompts.
  • Page 17 No shock was delivered to the victim because rescuer failed to press Shock Button or an error condition was detected. n SHOCKS DELIVERED. A total of n shocks have been delivered since the AED Plus was turned on. START CPR.
  • Page 18 Prompts that may be heard during non-clinical use of the AED Plus unit include: Table 2b Non-Clinical Voice Prompts Voice Prompt Definition IF NEW BATTERIES, Press the Battery Reset Button located in the battery compartment PRESS BUTTON. after replacing ALL batteries in the device with new batteries.

  • Page 19: Using The Lcd Display

    Using the LCD Display The AED Plus is equipped with a 1.3 x 2.6 inch LCD screen (see Figure 3) that displays the following information: CPR Depth of Compression Indicator Shock Count Elapsed Time 05:25 05:25 SHOCKS: 05 SHOCKS: 05 CHECK 2”...

  • Page 20: Using The Passive Airway Support System (Pass)

    Place the PASS under the victim to lift his/her shoulders. The unit cover also functions as the Passive Airway Do not use the PASS if there is a suspected head or neck Support System (PASS). injury. Figure 4: Using the PASS Cover ZOLL AED PLUS Administrator’s Guide...

  • Page 21: Using Electrodes

    • Replace electrodes, if expired • After the AED Plus is powered on and completes its self-test, the unit will issue an “Adult Pads” voice prompt or a “Pediatric Pads” voice prompt to indicate the type of electrodes connected to the unit.

  • Page 22: Applying Cpr-D-Padz

    Make certain that the CPR sensor maintains a position over the lower half of the breastbone. ® 0123 ® ZOLL Medical Corporation 269 Mill Road Chelmsford, MA 01824-4105 USA 978-421-9655 Figure 5: Placement of CPR-D-padz ZOLL AED PLUS Administrator’s Guide...

  • Page 23: Applying Pedi-Padz Ii (Infant/Child Electrodes)

    This symbol indicates that an AED Plus unit is equipped for treating adult and pediatric victims. An AED Plus unit without this symbol is not equipped to treat pediatric victims and will NOT work with the Pedi-padz II pediatric electrodes. To upgrade an AED Plus unit for use with ZOLL Pedi-padz II pediatric electrodes, contact ZOLL Medical Corporation or an authorized ZOLL distributor for information on the ZOLL AED Plus Pediatric Upgrade Kit.

  • Page 24: Using The Cpr Monitoring Function - Real Cpr Help

    Ensure that the CPR sensor is centered on the lower half of the victim’s sternum. 3. If no signs of circulation are present when the AED Plus issues the START CPR prompt, place your hands on top of the CPR sensor and push on the sensor to deliver chest compressions to the victim.

  • Page 25: Installation And Self Test

    AED Plus cover. NOTE If the electrodes are not connected to the AED Plus unit, the device will fail the self test and display a red “X” in the status indicator window.

  • Page 26: Using The Self Test Feature

    If the status indicator displays a red X following completion of any self test, the AED Plus is not ready for use and may be defective. Remove the AED Plus from service and consult the Troubleshooting section of this guide to help determine the problem.

  • Page 27: Power On Self Test

    7. Audio Circuitry: Verifies that voice prompts are functional. Manual Self Test You can initiate a manual self test on the AED Plus by pressing and holding the unit’s On/Off button for 5 seconds. The AED Plus illuminates all graphic indicators and issues voice and LCD display messages to allow user verification of the device’s visual and auditory output functionality.

  • Page 28: Automatic Self Test

    Automatic Self Test By default, the AED Plus unit performs an automatic self test once every 7 days (this interval can be configured to 1, 2, 3, 4, 5, 6, or 7 days) when the unit is stored with batteries installed. This self test verifies the following AED Plus functions: 1.
  • Page 29 For AED Plus units running software version 5.32 or higher, replace batteries every 5 years or if unit prompts. For earlier software versions, replace batteries every 3 years. A dated AED Plus battery replacement reminder label can be placed next to the On/Off button (available from ZOLL Customer Service).

  • Page 30: Identifying Battery Condition

    AED Plus. Using less than fully charged batteries can affect the unit when performing a rescue. DO NOT press the Battery Reset Button if all the batteries are not new. The AED Plus then assumes that they are the same batteries that were just removed.
  • Page 31 • displays a red “X” in the status indicator window, indicating that the batteries are at low capacity or that the AED Plus has failed other self tests. Table 3: Battery Condition Battery Condition Indications Correction Low Battery with AED Audible beep from AED Plus Replace batteries.

  • Page 32: Maintenance And Troubleshooting

    Check for adequate supplies. Cleaning the AED Plus • After each use, clean and disinfect the AED Plus with a soft, damp cloth using 90% isopropyl alcohol, or soap and water, or chlorine bleach and water mixture (30 ml/liter water).

  • Page 33: Optional Maintenance For Technical Professionals

    LCD). • If the AED Plus has an LCD, the message “SHOCKS: 0” appears in the upper left corner and the elapsed time (since power-up) appears in the upper right corner of the screen.

  • Page 34: Troubleshooting

    Troubleshooting The following table summarizes common error indications on the AED Plus, and their associated corrective action. Return the AED Plus to ZOLL’s Technical Service Department if the AED Plus is not working properly. Table 5: Troubleshooting Technical Problem Recommended Action Self test failed.

  • Page 35: Contacting Technical Service

    AED Plus is being repaired. Remove all batteries from the AED Plus and return the unit and batteries in its original container (or equivalent packaging) with the service order request number on it to the following address:...

  • Page 36: Zoll Administration Software

    AED Plus. The second IrDA port may be on your personal computer. In some cases, you will be sending data from the IrDA port on your AED Plus to an IrDA port on a modem which then transmits the data to a remote computer.

  • Page 37: Ordering Accessories

    Ordering Accessories You can order the following accessories from the ZOLL Customer Service Department. Table 6: Ordering Accessories Item CPR-D-padz electrode including accessory kit 8900-0800-01 Adult Stat-padz II electrode (single) 8900-0801-01 Adult Stat-padz II electrode (case) 8900-0802-01 Pedi-padz II electrode (single)
  • Page 38 Item Trainer AC Adapter 9355-0802 EURO 9355-0803 9355-0804 Switzerland 9355-0805 Australia 9355-0806 Trainer Cord 9355-0801 ZOLL AED PLUS Administrator’s Guide...

  • Page 39: Appendix A: Specifications

    Charge Time Less than 10 seconds with new batteries. Maximum time from first rhythm With new batteries: 12 seconds analysis to unit charged and ready With batteries depleted by 15 200J discharges: 13 seconds to shock ZOLL AED PLUS Administrator’s Guide...
  • Page 40 PASS (Passive Airway Support System) cover function are on file with ZOLL Medical Corporation and are available for review. Contact ZOLL Technical Support to request a copy of the following report(s) if desired: •...
  • Page 41 20MB disk space DATA RECORDING AND STORAGE Type Nonvolatile memory Capacity 7 hours of ECG and CPR data If audio recording option is installed and enabled: 20 minutes of audio recording, ECG, and CPR data ZOLL AED PLUS Administrator’s Guide...

  • Page 42: Guidance And Manufacturer's Declaration - Electromagnetic Emissions

    Compatibility Table 8: EMC Specifications The AED Plus is intended for use in the electromagnetic environment specified below. Operation outside of this environment could result in the misinterpretation of the ECG rhythms or CPR signals, interference to the display or audio messages, or the inability to provide defibrillation therapy.
  • Page 43 NOTE U is the AC mains voltage prior to application of the test level. The AED Plus is intended for use in the electromagnetic environment specified below. Operation outside of this environment could result in the misinterpretation of the ECG rhythms or CPR signals, interference to the display or audio messages, or the inability to provide defibrillation therapy.
  • Page 44 If the measured field strength in the location in which the AED Plus is used exceeds the applicable RF compliance level above, the AED Plus should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the AED Plus.
  • Page 45 AED Plus The AED Plus is intended for use in an environment in which radiated RF disturbances are controlled. The customer or the user of the AED Plus can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the AED Plus as recommended below, according to the maximum output power of the communications equipment.

  • Page 46: Rectilinear Biphasic Waveform Characteristics

    Fibrillation (VF) and Ventricular Tachycardia (VT) defibrillation study. This study (which was conducted using ZOLL M Series defibrillators) and the findings are described below. Since the AED Plus’s 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 ®...
  • Page 47 Figures 9 through 14 show the Rectilinear Biphasic waveforms that the AED Plus defibrillator produces when it discharges into loads of 25, 50, 75, 100, 125, 150, and 175 ohms at each energy setting (200, 150, 120, 85, 70, and 50 joules).
  • Page 48 Figure 11: Rectilinear Biphasic Waveforms at 120 joules Patient Impedance 25ohms 50ohms 75ohms 100ohms 125ohms 150ohms 175ohms Time (ms) Figure 12: Rectilinear Biphasic Waveforms at 85 joules Patient Impedance 25ohms 50ohms 75ohms 100ohms 125ohms 150ohms 175ohms Time (ms) ZOLL AED PLUS Administrator’s Guide...
  • Page 49 Figure 13: Rectilinear Biphasic Waveforms at 70 joules Patient Impedance 25ohms 50ohms 75ohms 100ohms 125ohms 150ohms 175ohms Time (ms) Figure 14: Rectilinear Biphasic Waveforms at 50 joules ZOLL AED PLUS Administrator’s Guide...

  • Page 50: Clinical Trial Results For The M Series Biphasic Waveform

    Clinical Trial Results for the M Series Biphasic Waveform The efficacy of ZOLL’s Rectilinear Biphasic Waveform has been clinically verified during a study of defibrillation of Ventricular Fibrillation (VF)/Ventricular Tachycardia (VT). A feasibility study was performed initially for defibrillation of VF/VT (n=20) on two separate groups of patients to ensure waveform safety and energy selection.

  • Page 51: Pre-Clinical Study

    To support pediatric usage for the ZOLL Rectilinear Bi-Phasic Waveform, ZOLL submitted pre-clinical data to the FDA as part of a 510(k) submission for its AED Plus device (cleared by the FDA under K033474). The protocol for this pre-clinical study, along with a summary of the results, have been submitted to FDA under AED Plus PMA application (P160015).

  • Page 52: Ecg Analysis Algorithm Accuracy

    (as a percentage of the total number of non-shockable rhythms). The data in Table 11 and Table 12 summarizes the accuracy of the ECG analysis algorithm as tested against ZOLL’s ECG Rhythm Database. The algorithm sequence takes approximately 9 seconds and proceeds as follows: •...
  • Page 53 Confidence Limit (%) Coarse VF 93.12 Rapid VT 96.28 98.57 AF, SB, SVT, 99.43 98.20 Heart block, idioventricular, PVCs Asystole 90.19 Fine VF Other VT 81.82 89.58 No Shock Shock Advised Advised Overall Performance Shockable Shockable ZOLL AED PLUS Administrator’s Guide...
  • Page 54 Young KD, Lewis RJ: “What is confidence? Part 2: Detailed definition and determination of confidence intervals”. Annals of Emergency Medicine, September 1997; 30; 311-218 “CRC Standard Mathematical Tables 28 Edition”, William H. Beyer, Ph.D., CRC Press, Inc, Boca Raton, FL., 1981, Percentage Points, F-Distribution Table, pg 573. ZOLL AED PLUS Administrator’s Guide...

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