ZOLL aed plus Administrator's Manual
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ZOLL aed plus Administrator's Manual

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Fully Automatic
AED Plus
Administrator's Guide
REF 9650-0311-05 Rev. B

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  • Page 1 Fully Automatic AED Plus Administrator’s Guide REF 9650-0311-05 Rev. B...
  • Page 2 This issue date for the ZOLL Fully Automatic AED Plus Administrator’s Guide, REF 9650-0311-05 Rev. B, is November, 2013. If more than three years have elapsed since the revision date, contact ZOLL Medical Corporation to determine if additional product information updates are available.

  • Page 3: Table Of Contents

    Using Real CPR Help ....................................2 ......................................3 PERATION Operating Controls and Indicators................................3 Using the Fully Automatic 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 ....................................
  • Page 4 Rectilinear Biphasic Waveform Characteristics ..........................36 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 ECG Analysis Algorithm Accuracy..............................42 Fully Automatic AED Plus Administrator’s Guide...

  • Page 5: Preface

    Fully Automatic AED Plus Operator’s Guide ( 9650-0310-01). The Fully Automatic AED Plus is to be used by trained rescuers to provide emergency defibrillation. It incorporates a sequence of visual and voice prompts to help rescuers follow established AHA/ERC Guidelines 2010 protocols for use of AEDs.

  • Page 6: Safety Summary

    (located on the left side of the handle) displays a red “X”. • DO NOT use or place the Fully Automatic AED Plus unit in service if the unit emits a beeping tone. • Connect the electrode cable to the Fully Automatic AED Plus unit after installing batteries.

  • Page 7: Cautions

    CPR-D-padz. Indications for Use Use the Fully Automatic AED Plus when a suspected cardiac arrest victim has an apparent LACK OF CIRCULATION as indicated by: • Unconsciousness; and •...

  • 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 victims Manufacturer Authorized representative in the European Community Serial Number Catalogue number Consult instructions for use Fully Automatic AED Plus Administrator’s Guide...
  • Page 10 Fully Automatic AED Plus Administrator’s Guide...

  • Page 11: Introduction

    ECG analysis. Some versions of the Fully Automatic AED Plus include a cover that can also 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.

  • Page 12: Using Real Cpr Help

    The metronome beeps at a minimum rate of 60 CPM in cases where the rescuer’s compression rate is substantially below 60 CPM. During CPR, the Fully Automatic AED Plus may issue one or more audible prompts based on the depth of chest compressions detected. When Real CPR Help determines that compression depth is consistently less than 5 cm, a PUSH HARDER prompt will be issued.

  • Page 13: Operation

    Operation This section describes the following functions: • Operating Controls and Indicators • Using the Fully Automatic AED Plus Graphical User Interface • Voice Prompts • Using the LCD Display • Using the Passive Airway Support System (PASS) • Using Electrodes •...
  • Page 14 Provides a communications link between the defibrillator and a personal computer or another IrDA equipped device. PASS Cover Some Fully Automatic AED Plus models include a cover that may be used as (optional) a shoulder support to aid victim airway management. The PASS can be ordered separately for other Fully Automatic AED Plus models (see “Ordering Accessories”...

  • Page 15: Using The Fully Automatic Aed Plus Graphical User Interface

    Using the Fully Automatic AED Plus Graphical User Interface The Fully Automatic 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 Fully Automatic 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 5 cm deep. STOP CPR. Stop CPR, the Fully Automatic AED Plus is about to begin an ECG rhythm analysis. Prompts that may be heard during non-clinical use of the Fully Automatic AED Plus unit include: Fully Automatic AED Plus Administrator’s Guide...
  • Page 18 ALL batteries in the device with new batteries. NON-RESCUE MODE. Fully Automatic AED Plus device has entered the diagnostics/data communications mode. COMMUNICATIONS IrDA Communications between the Fully Automatic AED Plus and a ESTABLISHED. personal computer or modem have been established. Fully Automatic AED Plus Administrator’s Guide...

  • Page 19: Using The Lcd Display

    Using the LCD Display The Fully Automatic 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...

  • 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 Fully Automatic AED Plus Administrator’s Guide...

  • Page 21: Using Electrodes

    WARNING! DO NOT use adult electrode pads or CPR-D-padz on victims under 8 years of age. The Fully Automatic AED Plus uses electrode packs that are connected to the unit by a cable. The package contains electrodes that you attach to the victim.

  • 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 Fully Automatic AED Plus Administrator’s Guide...

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

    6. Roll the victim onto his/her back and follow the Fully Automatic 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

    Shortly after you stop chest compressions to deliver rescue breaths the metronome will stop beeping. NOTE If the Fully Automatic AED Plus prompts you to PUSH HARDER, your compressions are less than 5 cm deep. Increase your compression depth to improve CPR performance.

  • Page 25: Installation And Self Test

    Fully Automatic AED Plus cover. NOTE If the electrodes are not connected to the Fully Automatic 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

    6. Audio Circuitry: Verifies that voice prompts are functional. At the end of this self test, the Fully Automatic AED Plus prompts the user to press the Battery Reset Button, located inside the battery compartment. Pressing this button resets the unit’s battery usage indicator to full charge.

  • 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 Fully Automatic AED Plus by pressing and holding the unit’s On/Off button for 5 seconds. The Fully Automatic AED Plus illuminates all graphic indicators and issues voice and LCD display messages to allow user verification of the device’s visual and auditory...

  • Page 28: Automatic Self Test

    Automatic Self Test By default, the Fully Automatic 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.
  • Page 29 The date code is MMYY. To install the batteries: 1. Ensure that the Fully Automatic AED Plus is turned off. Open the battery compartment by removing the battery cover from the back of the unit. To remove the battery cover, insert a small tool (e.g., flat blade screw driver) into the two slots on the rear of the unit to depress the latches, then insert the tool into the groove on the bottom to lift the cover (see Figure 7).

  • Page 30: Identifying Battery Condition

    Fully Automatic AED Plus: • emits an audible alarm or “beep” once every minute, if the Fully Automatic AED Plus is off • issues the CHANGE BATTERIES audio prompt, if the Fully Automatic AED Plus is on...
  • Page 31 • displays a red “X” in the status indicator window, indicating that the batteries are at low capacity or that the Fully Automatic AED Plus has failed other self tests. Table 3: Battery Condition Battery Condition Indications Correction Low Battery with Fully Audible beep from Fully Replace batteries.

  • Page 32: Maintenance And Troubleshooting

    Cleaning the Fully Automatic AED Plus • After each use, clean and disinfect the Fully Automatic 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

    (and displays the message if equipped with an LCD). • If the Fully Automatic 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 Fully Automatic AED Plus, and their associated corrective action. Return the Fully Automatic AED Plus to ZOLL’s Technical Service Department if the Fully Automatic AED Plus is not working properly.

  • Page 35: Contacting Technical Service

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

  • Page 36: Zoll Administration Software

    IrDA (infrared interface standard) ports. One IrDA port is located on the side of the Fully Automatic 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 Fully Automatic 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 Fully Automatic AED Plus Administrator’s Guide...

  • Page 39: Appendix A: Specifications

    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 Fully Automatic 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: Guidance And Manufacturer's Declaration - Electromagnetic Emissions

    Table 8: EMC Specifications The Fully Automatic AED Plus is intended for use in the electromagnetic environment specified below. The customer or the user of the Fully Automatic AED Plus should assure that it is used in such an environment.
  • Page 42 NOTE Ut is the a.c. mains voltage prior to application of the test level. The Fully Automatic AED Plus is intended for use in the electromagnetic environment specified below. The customer or the user of the Fully Automatic AED Plus should assure that it is used in such an environment.
  • Page 43 If the measured field strength in the location in which the Fully Automatic AED Plus is used exceeds the applicable RF compliance level above, the Fully Automatic 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 Fully Automatic AED Plus.
  • Page 44 Fully Automatic AED Plus The Fully Automatic AED Plus is intended for use in an environment in which radiated RF disturbances are controlled. The customer or the user of the Fully Automatic AED Plus can help prevent electromagnetic...
  • Page 45 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 Fully Automatic 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 ®...

  • Page 46: Rectilinear Biphasic Waveform Characteristics

    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 47 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) Fully Automatic AED Plus Administrator’s Guide...
  • Page 48 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 Fully Automatic AED Plus Administrator’s Guide...

  • Page 49: 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 50 “... 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).” Fully Automatic AED Plus Administrator’s Guide...
  • Page 51 • Measures amplitude and temporal regularity (“auto-correlation”) of peaks and troughs. • Determines if multiple 3 second segments are shockable then prompts the user to treat patient. • Stops analyzing the ECG after detecting a shockable rhythm and the AED Plus unit is charged and automatically delivers a shock.

  • Page 52: Ecg Analysis Algorithm Accuracy

    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. Fully Automatic AED Plus Administrator’s Guide...

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