ZOLL Aed Plus Administrator's Manual
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ZOLL Aed Plus Administrator's Manual

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Administrator's Guide
REF 9650-0301-01 Rev. M

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Summary of Contents for ZOLL Aed Plus

  • Page 1 Administrator’s Guide REF 9650-0301-01 Rev. M...
  • Page 2 This issue date for the ZOLL AED Plus Administrator’s Guide, Revision M, is July 2006. If more than three years have elapsed since the revision date, contact ZOLL Medical Corporation to determine if additional product information updates are available. ZOLL, AED Pro, stat•padz, pedi•padz, pro•padz, and v•pack are registered trademarks of ZOLL Medical Corporation.

  • Page 3: Table Of Contents

    Using the CPR Function ..............................2 ..................................3 PERATION Operating Controls and Indicators............................3 Using the ZOLL AED Plus Graphical User Interface ......................5 Voice Prompts..................................6 Using the LCD Display............................... 9 Using the Passive Airway Support System (PASS) ......................10 Using Electrodes ................................
  • Page 4 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions ................29 Rectilinear Biphasic Waveform Characteristics .......................33 Clinical Trial Results for the M Series Biphasic Waveform.....................34 Randomized Multi-Center Clinical Trial for Defibrillation of Ventricular Fibrillation (VF) and Ventricular Tachycardia (VT)..34 ECG Analysis Algorithm Accuracy..........................36 ZOLL AED PLUS Administrator’s Guide...

  • Page 5: Preface

    Safety Summary - Describes General Warnings and Cautions. Introduction- Provides a general product overview of the ZOLL AED Plus. Section 1 - Operation - Describes the functions of all controls and indicator lights of the ZOLL 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 ZOLL 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

    • Absence of a pulse or signs of circulation. 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 ZOLL AED Plus Pediatric Electrodes. Therapy should not be delayed to determine the patient’s exact age or weight.

  • Page 8: Tracking Requirements

    If any of the events described above occur, please contact ZOLL Medical Corporation in writing with the following information: 1. Originator’s organization - Company Name, Address, Contact Name and Contact Phone Number.

  • Page 9: Symbols

    Push button Do not use this manufacturer Ok to use this manufacturer Unit equipped to treat adult and pediatric patients Manufacturer Authorized representative in the European Community Serial Number Catalogue number Consult instructions for use ZOLL AED PLUS Administrator’s Guide...
  • Page 10 ZOLL AED PLUS Administrator’s Guide...

  • Page 11: Introduction

    ECG analysis. Some versions of the ZOLL AED Plus include a cover that can also be used as a PASS (Passive Airway Support System) to support the patient’s neck and shoulders in a position that assists in maintaining an open airway.

  • Page 12: Using The Cpr Function

    60 CPM in cases where the rescuer’s compression rate is substantially below 60 CPM. During CPR, the ZOLL AED Plus may issue one or more audible prompts based on the depth of chest compressions detected. When the CPR monitoring system determines that compression depth is consistently less than 1½...

  • Page 13: Operation

    Operation This section describes the following functions: • Operating Controls and Indicators • Using the ZOLL AED Plus Graphical User Interface • Voice Prompts • Using the LCD Display • Using the Passive Airway Support System (PASS) • Using Electrodes •...
  • Page 14 IrDA equipped device. PASS Cover Some ZOLL AED Plus models include a cover that may be used as a (optional) shoulder support to aid patient airway management. The PASS can be ordered separately for other ZOLL AED Plus models (see "Ordering Accessories"...

  • Page 15: Using The Zoll Aed Plus Graphical User Interface

    Using the ZOLL AED Plus Graphical User Interface The ZOLL 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 ZOLL 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 GOOD COMPRESSIONS. After prompting to Push Harder, rescuer has succeeded in delivering chest compressions at least 1 ½ inches deep. STOP CPR. Stop CPR, the ZOLL AED Plus is about to begin an ECG rhythm analysis. ZOLL AED PLUS Administrator’s Guide...
  • Page 18 Prompts that may be heard during non-clinical use of the ZOLL 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 ZOLL 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 1.5”...

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

    Place the PASS under the patient 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 ZOLL 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. ZOLL Medical Corporation 269 Mill Road Chelmsford, MA 01824-4105 USA 978-421-9655 Figure 5: Placement of CPR-D padz...

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

    6. Roll the patient onto his/her back and follow the ZOLL AED Plus prompts. NOTE The Pedi Padz II (infant/child electrodes) can also be used with ZOLL pacemaker products for up to one hour of pacing (see the M Series Operator’s Guide for information about pacing).

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

    NOTE If the ZOLL AED Plus prompts you to PUSH HARDER, your compressions are less than 1½ inches deep. Increase your compression depth to improve CPR performance.

  • Page 25: Installation And Self Test

    ZOLL AED Plus cover. NOTE If the electrodes are not connected to the ZOLL 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 ZOLL AED Plus is not ready for use and may be defective. Remove the ZOLL AED Plus from service and consult the Troubleshooting section of this guide to help determine the problem.

  • Page 27: Power On Self Test

    Manual Self Test You can initiate a manual self test on the ZOLL AED Plus unit by pressing and holding the unit’s On/ Off button for 5 seconds. The ZOLL 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...

  • Page 28: Automatic Self Test

    Automatic Self Test By default, the ZOLL AED Plus unit performs an automatic self test once every seven (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.
  • Page 29 After placing the first 5 to 9 batteries in the battery well, the INSTALL BATTERIES audio prompt reminds you to install the remaining batteries in the battery compartment. Battery Reset Button Figure 8: Battery Compartment ZOLL AED PLUS Administrator’s Guide...

  • Page 30: Identifying Battery Condition

    Replace batteries as soon as powered on. (unit powered on). possible. Dead Battery. Status Indicator has red “X” Replace batteries. If red “X” indicating failure to operate remains, return to ZOLL (when off). Technical Support for service. ZOLL AED PLUS Administrator’s Guide...

  • Page 31: Maintenance And Troubleshooting

    Maintenance and Troubleshooting This section describes the following functions to maintain the ZOLL AED Plus: • Maintaining the Unit • Cleaning the Unit • Optional Maintenance for Technical Professionals • Troubleshooting Maintaining the Unit • Inspect frequently, as necessary. • Check for the green check ( showing that the unit is ready to use.

  • Page 32: Optional Maintenance For Technical Professionals

    (since power-up) appears in the upper right corner of the screen. 3. Using the simulator, input a VF rhythm to the ZOLL AED Plus. Verify that after the ZOLL AED Plus unit proceeds through its sequence of patient assessment prompts, it: •...

  • Page 33: Troubleshooting

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

  • Page 34: Contacting Technical Service

    • Purchase Order or credit card number for a unit with an expired warranty. If you need to send the unit to ZOLL Medical Corporation, obtain a service order request number from the Technical Service representative. Units are available on loan at an additional cost while your unit is being repaired.

  • Page 35: Zoll Administration Software

    See the RescueNet Code Review User’s Guide for more information. Setting Up Data Communications You can exchange data between a ZOLL AED Plus unit and a personal computer without any cable ™ connection by transferring data using two IrDA (infrared interface standard) ports. One IrDA port ™...

  • Page 36: 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...

  • Page 37: Appendix A: Specifications

    (Adult mode: 120J, 150J, 200J; Pediatric mode: 50J, 70J, 85J) Patient Safety All patient connections are electrically isolated. Charge Time Less than 10 seconds with new batteries. Electrodes ZOLL stat padz II, CPR-D padz or Pedi Padz II Built in Defibrillator Self Test Included ZOLL AED PLUS Administrator’s Guide...
  • Page 38 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 39: Guidance And Manufacturer's Declaration - Electromagnetic Emissions

    Table 8: EMC Specifications The ZOLL AED Plus is intended for use in the electromagnetic environment specified below. The customer or the user of the ZOLL AED Plus should assure that it is used in such an environment. Emissions test...
  • Page 40 NOTE Ut is the a.c. mains voltage prior to application of the test level. The ZOLL AED Plus is intended for use in the electromagnetic environment specified below. The customer or the user of the ZOLL AED Plus should assure that it is used in such an environment.
  • Page 41 If the measured field strength in the location in which the ZOLL AED Plus is used exceeds the applicable RF compliance level above, the ZOLL 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 ZOLL AED Plus.
  • Page 42 ZOLL AED Plus The ZOLL AED Plus is intended for use in an environment in which radiated RF disturbances are controlled. The customer or the user of the ZOLL AED Plus can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ZOLL AED Plus as recommended below, according to the maximum output power of the communications equipment.

  • Page 43: Rectilinear Biphasic Waveform Characteristics

    Ventricular 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 ZOLL AED Plus's rectilinear biphasic waveform employs the same first and second phase timing,...

  • Page 44: 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 45 “... the task force suggests that to demonstrate superiority of an alternative waveform over standard waveforms, the upper boundary of the 90% confidence interval of the difference between standard and alternative waveforms must be < 0% (i.e., alternative is greater than standard).” ZOLL AED PLUS Administrator’s Guide...

  • Page 46: Ecg Analysis Algorithm Accuracy

    (as a percentage of the total number of non-shockable rhythms). The data in Table 10 and Table 11 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 47 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...
  • Page 48 ZOLL AED PLUS Administrator’s Guide...

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