AED Plus Administrator’s Guide ® 9650-0301-01 Rev.
This issue date for the ZOLL AED Plus Administrator’s Guide, (REF 9650-0301-01 Rev V) is September, 2012. 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 © 2012 ZOLL Medical Corporation. All rights reserved.
Table of Contents PREFACE ................................................................................................................................................................................................... v SAFETY SUMMARY.................................................................................................................................................................................. vi Warnings....................................................................................
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions ................................................................................... 32 Rectilinear Biphasic Waveform Characteristics ............................................................................................................................... 36 Clinical Trial Results for the M Series Biphasic Waveform...........................................................................................................
Preface The AED Plus® Administrator’s Guide is to be used by responsible medical authorities in conjunction with the ZOLL AED Plus Operator’s Guide (REF 9650-0300-01). The 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.
Safety Summar y The following section describes general warnings and safety considerations for administrators, rescuers, and patients. Warnings • Use the AED Plus unit only as described in this manual. Improper use of the device can cause death or injury. • DO NOT use or place the AED Plus unit in service until you have read the AED Plus Operator’s and Administrator’s Guides.
Cautions • Do not disassemble the unit. A shock hazard exists. Refer all servicing to qualified personnel. • Use only commercially available type 123A lithium manganese dioxide batteries. Discard batteries properly after removal from unit. Use only batteries from recommended manufacturers. • If the device is stored outside the recommended environmental conditions, the electrode pads and/ or batteries may be damaged or their useful life reduced.
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. If any of the events described above occur, please contact ZOLL Medical Corporation in writing with the following information: 1.
Symbols Symbols used in this manual or on the equipment include the following: Class II equipment Defibrillation protected Type BF patient connection ATTENTION: Refer to manual for more information DANGEROUS VOLTAGE Not new battery cells New battery cells Do Not push button 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
x ZOLL AED PLUS Administrator’s Guide
Introduction Using the ZOLL AED Plus The AED Plus is an automated external defibrillator (AED) that uses voice prompts and visual indicators to guide the rescuer through a resuscitation sequence that may include defibrillation and/or cardiopulmonary resuscitation (CPR). The unit incorporates the ZOLL Rectilinear Biphasic Defibrillation waveform, and operates in either adult or pediatric mode.
Using Real CPR Help ® The CPR-D•padz include a sensor that detects the rate and depth of CPR chest compressions. This sensor is placed (as part of the electrodes application) on the victim’s chest so that it is located between the rescuer’s hands and the victim’s lower sternum during chest compressions. When the rescuer performs CPR compressions, the sensor detects their rate and depth and sends the information to the AED Plus unit.
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 • Applying pedi-padz II® (Infant/Child Electrodes) • Using the CPR Monitoring Function — Real CPR Help • Using the Audio Recording Option Operating Controls and Indicators See Table 1: Control Functions for an explanation of each of these co
Table 1: Control Function Control/Indicator Description ON/OFF Button Turns power ON or OFF. When held depressed for > 5 seconds initiates self test or data communications. Indicator lights 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.
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. Each pictogram on the device is associated with an indicator light (LED) and voice prompts.
The AED Plus automatically adjusts defibrillation energy to adult or pediatric levels based on the type of electrodes attached to the unit. In its factory default configuration, the unit delivers the first three shocks at 120J, 150J, and 200J respectively in adult mode, and at 50J, 70J, and 85J in pediatric mode. However, the device can be configured to deliver shocks at other energy levels, as long as the setting for each successive shock is the same or greater than the setting for the preceding shock.
Voice Prompt Definition ADULT PADS. AED Plus has detected adult electrode pads connected to it and adjusted defibrillation energy settings to adult levels. PEDIATRIC PADS. AED Plus has detected pediatric electrode pads connected to it and adjusted defibrillation energy settings to pediatric levels. DON’T TOUCH PATIENT, ANALYZING. Do not touch victim, an ECG rhythm analysis is in progress or about to begin. SHOCK ADVISED.
Prompts that may be heard during non-clinical use of the AED Plus unit include: Table 2b Non-Clinical Voice Prompts 8 Voice Prompt Definition IF NEW BATTERIES, PRESS BUTTON. Press the Battery Reset Button located in the battery compartment after replacing ALL batteries in the device with new batteries. NON-RESCUE MODE. AED Plus device has entered the diagnostics/data communications mode. COMMUNICATIONS ESTABLISHED.
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: Shock Count Elapsed Time CPR Depth of Compression Indicator 05:25 SHOCKS: 05 CHECK RESPONSIVENESS SHOCKS: 05 2” (5 cm) depth CHECK RESPONSIVENESS 2.4” (6 cm) depth With ECG 05:25 2” (5 cm) depth 2.4” (6 cm) depth Without ECG Figure 3: LCD Displays NOTE Some special AED Plus models do not have an LCD.
Using the Passive Airway Support System (PASS) If there is no evidence of head or neck trauma, the head tilt chin lift method is the recommended maneuver for opening the airway. The PASS may be placed under the victim’s shoulders to help maintain head tilt. WARNING! DO NOT use PASS if suspected head or neck injury. Place victim on a firm surface before performing CPR.
Using Electrodes WARNING! DO NOT reuse electrodes. The AED Plus supports both adult and pediatric electrode pads. The device automatically adjusts defibrillation energy to adult or pediatric levels depending on the type of electrodes connected to it. Make sure that the electrode pads used are appropriate for the victim. WARNING! DO NOT use adult electrode pads or CPR-D•padz on victims under 8 years of age. The AED Plus uses electrode packs that are connected to the unit by a cable.
Applying CPR-D-padz Prepare the victim before attaching the electrodes. WARNING! CPR-D-padz are intended for use on adult victims only; do not use on victims under 8 years of age. To prepare the victim: 1. Remove all clothing covering the victim’s chest. 2. Ensure the victim’s chest is dry. 3. If the victim has excessive chest hair, clip or shave the hair to help ensure proper adhesion of the electrodes. To apply the electrodes: 1. Tear open the electrode package and unfold the electrodes.
Applying pedi•padz II (Infant/Child Electrodes) Prepare the victim before attaching the electrodes. Important! 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.
Using the CPR Monitoring Function — Real CPR Help When used with ZOLL CPR-D-padz, the AED Plus monitors the rate and depth of CPR chest compressions. The AED Plus provides a CPR adaptive metronome function 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 minimum compression depth of 2 inches for adult victims.
Installation and Self Test This section describes the following functions to prepare the AED Plus for use: • Inspecting the Unit • Preparing the AED Plus for Use • Using the Self Test Feature • Installing or Replacing Batteries • Identifying Battery Condition Inspecting the Unit Once unpacked, inspect the device for any signs of damage due to shipping. Check for accessories and any other parts ordered.
Using the Self Test Feature The AED Plus performs the following self tests to verify unit integrity and its readiness for emergency use: • Battery Installation Self Test • Power On Self Test • Manual Self Test • Automatic Self Test • Automatic Monthly Test (software version 5.32 or higher only) Following successful completion of all self tests, the AED Plus’s status indicator displays a green check () to show that all tests passed and that the unit is ready to use.
Power On Self Test The AED Plus performs a self test whenever the unit is turned on and verifies the following functions: 1. Battery Capacity: Verifies that the battery usage indicator shows adequate battery capacity remaining. 2. Defibrillation Electrodes Connection: Verifies that the defibrillation electrodes are properly preconnected to the device. 3. ECG Circuitry: Verifies that the ECG signal acquisition and processing electronics are functional. 4.
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. Battery Capacity: Verifies that the battery usage indicator shows adequate battery capacity remaining. NOTE For units with softeware below version 5.32, batteries must be replaced every 3 years regardless of test results. 2.
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). CAUTION! Use Duracell, Sanyo or Varta batteries only. Do not use Panasonic or Rayovac batteries.
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). 2) Lift cover here Battery Compartment Door 1) Depress latch here Figure 7: Removing the Battery Compartment Door 2. Remove all batteries at once and dispose of batteries properly.
3. After installing new batteries, press the Battery Reset Button inside the battery compartment when prompted (see Figure 8). Pressing the button resets the battery usage indicator to full charge. CAUTION! You MUST replace all 10 batteries at once. Do not replace individual batteries. The AED Plus cannot detect whether all batteries or only a few batteries have been replaced. Do not place used batteries into the AED Plus. Using less than fully charged batteries can affect the unit when performing a rescue.
Maintenance and Troubleshooting This section describes the following functions to maintain the AED Plus: • Maintaining the AED Plus • Cleaning the AED Plus • Optional Maintenance for Technical Professionals • Troubleshooting Maintaining the AED Plus • • • • • • Inspect frequently, as necessary. Check for the green check () showing that the AED Plus is ready to use. Verify that electrodes are within their expiration date. Verify that batteries are within their expiration date.
Optional Maintenance for Technical Professionals The AED Plus automatically performs maintenance testing during periodic self tests. However, if a qualified technical professional wishes to test the AED Plus further, the following checkout procedure can be followed: 1. Connect an AED Plus Simulator/Tester (or equivalent) to the AED Plus electrode connector. 2. Power on the simulator and AED Plus.
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 24 Technical Problem Recommended Action Self test failed. Initiate manual self test by pressing and holding the ON/OFF Button for more than 5 seconds. Attempt to repair the device by replacing the batteries or electrodes.
Contacting Technical Service If a ZOLL product requires service, contact the ZOLL Technical Service Department: Telephone: Toll free: Fax: 1-978-421-9655 1-800-348-9011 1-978-421-0010 Have the following information available for the Technical Service representative: • Unit serial number. • Description of the problem. • Purchase Order or credit card number to allow tracking of loan equipment. • Purchase Order or credit card number for a unit with an expired warranty.
ZOLL Administration Software ZOLL Administration Software (ZAS) helps you perform software maintenance tasks when your defibrillator is connected to your personal computer (PC). ZAS lets you upload data from a defibrillator to a PC, then transmit that data to your main network, or print the data locally from your PC to your printer. See the online Help for instructions on how to use ZAS. Installing ZOLL Administration Software To install ZAS, insert the ZAS CD into the CD-ROM drive on your PC.
Ordering Accessories You can order the following accessories from the ZOLL Customer Service Department.
REF Item Trainer AC Adapter US EURO UK Switzerland Australia Trainer Cord 28 9355-0802 9355-0803 9355-0804 9355-0805 9355-0806 9355-0801 ZOLL AED PLUS Administrator’s Guide
Appendix A: Specifications Table 7: General Specifications DEVICE Size (H x W x D) 5.25" x 9.50" x 11.50"; 13.3 cm x 24. 1 cm x 29.2 cm Weight 6.7 lbs.; 3.1 kg Power User Replaceable Batteries.
DEFIBRILLATOR (cont’d) Maximum time from power on to unit charged and ready to shock at 200J 22.6 seconds Electrodes ZOLL stat-padz II, CPR-D-padz or pedi-padz II Built in Defibrillator Self Test Included CPR *Metronome Rate: Variable 60 to 100 CPM Depth: ¾" to 3"; 1.9 to 7.6 cm Defibrillation Advisory Evaluates electrode connection and patient ECG to determine if defibrillation is required.
DEFIBRILLATOR (cont’d) PC Minimum Requirements Windows® 98, Windows® 2000 Windows®NT, Windows® XP IBM-compatible PII with 16550 UART (or higher) computer 64MB RAM.
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions Table 8: EMC Specifications The AED Plus is intended for use in the electromagnetic environment specified below. The customer or the user of the AED Plus should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR11 Group 1 The AED Plus uses RF energy only for its internal function.
Immunity test IEC 60601 test level Compliance level Voltage dips, short interruptions and voltage variations on power supply input lines. IEC 61000-4-11 <5% Ut (>95% dip in Ut) for 0.
Immunity test (cont’d) IEC 60601 test level (cont’d) Compliance level (cont’d) Electromagnetic environment guidance (cont’d) Recommended separation distance Radiated RF IEC 61000-4-3 10 V/m 80 MHz to 2.5 GHz 10 V/m d = 1.20 P 80 MHz to 800 MHz d = 2.30 P 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 and d is the recommended separation distance in metres (m).
Recommended separation distances between portable and mobile RF communications equipment and the 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.
Rectilinear Biphasic Waveform Characteristics The following table shows the Rectilinear Biphasic waveform’s characteristics when discharged into 25 ohm, 50 ohm, 100 ohm, and 125 ohm loads at a maximum energy setting of 200 joules.
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). The vertical axis shows the current in amperes (A); the horizontal axis shows the duration in milliseconds (ms).
30 Patient Impedance 25ohms 50ohms 75ohms 100ohms 125ohms 150ohms 175ohms 25 20 Current (A) 15 10 5 0 -5 -10 -15 -20 0 2 4 6 8 10 Time (ms) 12 14 16 18 20 Figure 11: Rectilinear Biphasic Waveforms at 120 joules 25 Patient Impedance 25ohms 50ohms 75ohms 100ohms 125ohms 150ohms 175ohms 20 15 Current (A) 10 5 0 -5 -10 -15 -20 0 2 4 6 8 10 Time (ms) 12 14 16 18 20 Figure 12: Rectilinear Biphasic Waveforms at 85 joules 25 Patient Impedance 25ohms 50ohms 75ohms 100ohms 125ohms 150ohm
Figure 13: Rectilinear Biphasic Waveforms at 70 joules 20 Patient Impedance 25ohms 50ohms 75ohms 100ohms 125ohms 150ohms 175ohms 15 Current (A) 10 5 0 -5 -10 -15 0 2 4 6 8 10 Time (ms) 12 14 16 18 20 Figure 14: Rectilinear Biphasic Waveforms at 50 joules ZOLL AED PLUS Administrator’s Guide 39
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. Subsequently a separate, multi-center, randomized clinical trial was performed to verify the waveform’s efficacy.
The difference in efficacy between the rectilinear biphasic and the monophasic shocks was greater in patients with high transthoracic impedance (greater than 90 ohms). The first shock, first induction efficacy of biphasic shocks was 100% versus 63% for monophasic shocks for patients with high impedance (p=0.02, 95% confidence interval of the difference of -0.021% to 0.759% and 90% confidence interval of the difference of 0.037% to 0.706%).
ECG Analysis Algorithm Accuracy Sensitivity and specificity are expressions of ECG analysis algorithm performance when compared to ECG interpretation by a clinician or expert. Sensitivity refers to the algorithm’s ability to correctly identify shockable rhythms (as a percentage of the total number of shockable rhythms); specificity refers to the algorithm’s ability to correctly identify non-shockable rhythms (as a percentage of the total number of non-shockable rhythms).
Table 12: Clinical Performance Results (Pediatric Patients) Rhythms Sample Size (9 second records) Performance Goals Observed Performance 90% One-sided Lower Confidence Limit 42 51 >90% sensitivity >75% sensitivity 100% (42/42) 92.2% (47/51) 93.1% 82.9% 229 415 >99% specificity >95% specificity 100% (229/229) 98.7% 100% (415/415) 99.3% 14 >95% specificity 100% (14/14) 80.7% 0 22 Report only Report only NA 77.3% (17/22) --58.
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