User’s Guide Cardiac Science Powerheart® Automated External Defibrillator 70-01704-01 B
USER’S GUIDE POWERHEART® G5 AUTOMATED EXTERNAL DEFIBRILLATOR 70-01704-01 B
Information in this document is subject to change without notice. Names and data used in the examples are fictitious unless otherwise noted. Trademark Information Cardiac Science, the Shielded Heart logo, Powerheart, STAR‚ Intellisense‚ Rescue Ready‚ RescueCoach‚ and RHYTHMx are trademarks or registered trademarks of Cardiac Science Corporation. All other product and company names are trademarks or registered trademarks of their respective companies. Copyright © 2015 Cardiac Science Corporation.
Contents Chapter 1: About the AED Appendix A: RescueCoach™ Voice and Text Prompts AED overview...........................................................................................................1-1 AED parts...................................................................................................................1-2 The display panel....................................................................................................1-2 Defibrillation pads.....................................
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1 About the AED Contents ◆ AED overview .......................................................................................1-1 ◆ AED parts ...............................................................................................1-2 ◆ The display panel ................................................................................1-2 ◆ Defibrillation pads ............................................................................. 1-3 ◆ CPR feedback device ......................................
About the AED AED parts Pad expiration window Rescue Ready® status indicator Lid Battery compartment (on bottom) Pad package holders Latch (press to open) Speaker RE RE Y A D RE Pad socket/USB port S CUE S CUE RE Y A D Display (details below) AED is not Rescue Ready. AED is Rescue Ready. Rescue Ready technology assesses the AED, battery, and pads to ensure they are ready to perform a rescue.
About the AED Defibrillation pads The AED comes with defibrillation pads installed. Pads are stored in a ready-to-use, sealed package. The preinstalled pads are for use with adults and children 8 years and older or over 55lbs. If the child appears younger or lighter do not delay treatment to determine the child’s exact age or weight, use the preinstalled pads. Pads are self-adhesive with an attached cable and connector for power and ECG transmission. Pads are disposable; discard after use in a rescue.
About the AED 1-4 70-01704-01 B Powerheart® G5 Automated External Defibrillator
2 Steps to a Rescue These are the general steps in performing a rescue: 1: Assess the patient (page 2-2) 2: Prepare the patient (page 2-2) 3: Place the defibrillation pads (page 2-2) 4: Analyze the patient’s ECG (page 2-3) 5: Deliver a defibrillation shock (page 2-3) 6: Give CPR (page 2-4) 7: Prepare the AED for the next rescue (page 2-4) Powerheart® G5 Automated External Defibrillator 70-01704-01 B 2-1
Steps to a Rescue 1: Assess the patient 2: Prepare the patient Determine that the patient is more than 8 years of age or weighs more than 25 kg (55 lbs) and is both: 1. Place the AED next to the patient. Note: The normal use for the AED is with it lying horizontally. ◆ Unresponsive 2. Open the AED lid. ◆ Not breathing or not breathing normally 3. Remove clothing from the patient’s chest. DO NOT delay therapy to determine the patient’s exact age or weight. CALL EMERGENCY MEDICAL SERVICES! 4.
Steps to a Rescue 4: Analyze the ECG When the AED prompts… Do this… “Do not touch the patient! Analyzing heart rhythm. Please wait.” 1. Do not touch the patient. 2. Wait for the next prompt. The AED begins analyzing the cardiac rhythm of the patient. During the analysis phase, you may hear one or more of these prompts: If the AED prompts… This is the problem… Do this… “Open lid to continue rescue” The lid of the AED is closed. Ensure that the lid is fully open.
Steps to a Rescue 6: Give CPR After the AED delivers a shock or detects a non-shockable rhythm, it enters CPR mode. When the AED prompts… Do this… “If needed, perform CPR as instructed.” Perform CPR according to the prompts. Follow the countdown timer on the text display. Important: If the AED is not operating as expected, it is preferable to perform CPR without the aid of the AED than to delay providing CPR.
3 Safety Contents ◆ Indications for use ............................................................................. 3-1 ◆ Safety alert descriptions ................................................................. 3-1 ◆ Warnings and cautions .................................................................... 3-1 ◆ Symbols and labels ........................................................................... 3-3 Before operating the AED, become familiar with the various safety alerts in this section.
Safety ! WARNING! Shock hazard Defibrillation shock current flowing through unwanted pathways is potentially a serious electrical shock hazard. To avoid this hazard during defibrillation, abide by all of the following: • • • • • Do not use in standing water or rain.
Safety ! CAUTION. Use only Cardiac Science approved equipment Using batteries, pads, cables, or optional equipment other than those approved by Cardiac Science may cause the AED to function improperly during a rescue; therefore Cardiac Science does not endorse their use. The use of non-approved accessories, if proved to contribute to a device malfunction, shall void any and all support from Cardiac Science. ! CAUTION. Possible improper AED performance ! CAUTION.
Symbol Description Symbol Description Manufacturer. Product model number. Lot number. LOT Date of manufacture, year, month and day. Dispose of properly in accordance with all state, province, and country regulations. YYYY-MM-DD Use pads by the date shown. Recycle cardboard according to local law. Latex free. Not made with natural rubber latex. Disposable. Single patient use only. Waste Electronic Electrical Equipment (WEEE). Separate collection for waste electrical and electronic equipment.
4 AED Features Contents ◆ Dual languages .................................................................................. 4-1 ◆ Prompting levels ................................................................................ 4-1 ◆ CPR behavior types ........................................................................... 4-2 ◆ AED device history and rescue data recording ...................... 4-2 ◆ AED Manager software ...................................................................
AED Features CPR behavior types The AED includes optional settings for configuring the style of CPR. Combining the prompting levels and CPR behavior types, AEDs can be configured in many ways.
5 Troubleshooting Contents ◆ Self-tests ............................................................................................... 5-1 ◆ Troubleshooting of indicators ...................................................... 5-2 ◆ Maintenance and service messages ........................................... 5-3 ◆ Diagnostic mode messages ...........................................................
Troubleshooting Troubleshooting of indicators Use this table to troubleshoot the AED if an indicator is lit. Important: Do not delay calling emergency medical services and delivering CPR even if the AED cannot assist with the rescue. Indicator RE S CUE Symptom Resolution Rescue Ready status indicator is red and the service indicator is NOT lit. Close and reopen the lid of the AED. The Rescue Ready indicator may return to green. Both the Rescue Ready status indicator and the service indicator are red.
Troubleshooting Maintenance and service messages These messages may appear during a periodic self-test or during a rescue at any prompt level. Use the following table to resolve messages that the AED might display. Voice prompt Text display Line 1 Line 2 Battery Low Situation Resolution BATTERY LOW The battery charge is low, although a rescue can continue for approximately 9 more shocks. Replace the battery before the next rescue.
Troubleshooting Diagnostic mode messages Diagnostic mode provides detail on the maintenance and service conditions of the AED. For example, if the AED is not Rescue Ready, diagnostic mode displays additional information about the status. To enter Diagnostic mode: ◆ Press and hold both buttons on the AED display panel for three seconds. Press The following prompts appear when the AED is in Diagnostic mode. Use the table to resolve the reported conditions.
6 Product Care Contents ◆ Periodic maintenance ...................................................................... 6-1 ◆ Cleaning and care .............................................................................. 6-2 ◆ Authorized service ............................................................................ 6-2 This section presents information about AED product care and cleaning. Periodic maintenance Cardiac Science Corporation provides customer service and technical support.
4. Confirm that the Rescue Ready indicator turns red and the AED beeps at a regular interval. If no sound is heard, contact Cardiac Science Technical Support, or outside the U.S., your local representative. 5. Check the expiration date of the pads; if expired, replace the package. 6. Check that the pads packaging is not ripped or punctured. Replace the package as needed. 7. Open the lid and confirm that the defibrillation pads indicator is lit. 8.
A RescueCoach™ Voice and Text Prompts Contents ◆ Start up ..................................................................................................A-1 ◆ Pads placement ..................................................................................A-2 ◆ Pads prompts ......................................................................................A-3 ◆ Analysis .................................................................................................
RescueCoach™ Voice and Text Prompts Table A-2: Pads placement Voice prompt Text display Line 1 Line 2 Begin by exposing patient’s bare chest. BARE PATIENT’S CHEST REMOVE ALL CLOTHING Remove or cut clothing if needed. Prompt level Adv Std Prompts the rescuer to remove patient clothing. X X BARE PATIENT’S CHEST REMOVE ALL CLOTHING Prompts the rescuer to remove patient clothing. X When patient’s chest is bare, remove the white, square package from lid of AED.
RescueCoach™ Voice and Text Prompts Table A-3: Pads prompts Text display Line 1 Line 2 Situation Pediatric Pads Connected PEDIATRIC PADS Make sure pad connector is plugged into AED Press pads firmly to patient’s bare chest Voice prompt Prompt level Adv Std Bas Notifies rescuer that the pediatric pads are connected to the AED. X X X CHECK CONNECTOR IS PLUGGED INTO AED Prompts when defibrillation pads connector is not inserted into the pad socket.
RescueCoach™ Voice and Text Prompts Table A-5: Delivering therapy - G5 semi-automatic (continued) Voice prompt Text display Line 1 Line 2 Shock not delivered. SHOCK NOT DELIVERED It is now safe to touch the patient. NOW SAFE TO TOUCH PATIENT Prompt level Situation Adv Std Bas Plays for either of these situations: • The SHOCK button is not pressed within 30 seconds of the AED giving the “Press red flashing button...” prompt. • The AED is unable to deliver a shock because of a fault condition.
RescueCoach™ Voice and Text Prompts Table A-7: CPR Voice prompt Text display Line 1 Line 2 Prompt level Situation If needed, perform compressions as instructed. IF NEEDED GIVE COMPRESSIONS Give compressions as instructed Adv Std Bas If the AED detects a nonshockable rhythm, prompts rescuer to prepare to provide compressions-only CPR. X X GIVE COMPRESSIONS Prompts rescuer to prepare to provide compressionsonly CPR. X X If needed, perform CPR as instructed.
RescueCoach™ Voice and Text Prompts Table A-8: CPR feedback device (optional) Voice prompt Text display Line 1 Line 2 Prompt level Situation Remove green square package from lid of AED. REMOVE GREEN SQUARE PACKAGE FROM AED LID Tear open green package and remove CPR device. Adv Std Prompts at the beginning of a CPR session. The green package contains the CPR device. X X TEAR OPEN PACKAGE REMOVE CPR DEVICE Prompts to remove the CPR device.
RescueCoach™ Voice and Text Prompts Table A-9: Data transfer Voice prompt Text display Line 1 Line 2 Prompt level Situation Communications mode COMMUNICATIONS MODE Adv Std Bas Played when AED enters Communications mode. X X X DO NOT DISCONNECT USB Prompts when data is transferred between the AED and the flash drive. Disconnecting the flash drive can corrupt the data being transferred. X X X SAFE TO REMOVE USB Prompts after the data transfer completes. Remove the flash drive.
RescueCoach™ Voice and Text Prompts Table A-10: Language selection Voice prompt A-8 70-01704-01 B Text display Line 1 Line 2 Prompt level Situation Adv Std Bas ENGLISH On multi-lingual AED models only: appears above a button on the display panel. Press the button to switch the prompting language (both audio and text) to this language. X X X FRENCH On multi-lingual AED models only: appears above a button on the display panel.
B Technical Data Contents ◆ Powerheart G5 parameters ............................................................ B-1 ◆ Defibrillation pads .............................................................................B-3 ◆ Intellisense® battery (model XBTAED001) .................................B-3 This section lists the physical, operating, standby, and storage parameters of the AED, and the physical parameters of the defibrillation pads and AED battery.
Technical Data Table 3: Functionality Table 3: Functionality (Continued) Parameter Detail Parameter Detail RHYTHMx® ECG analysis performance The AED RHYTHMx ECG Analysis system analyzes the patient’s ECG and advises you when the AED detects a shockable or non-shockable rhythm. Internal data storage 90 minutes This system makes it possible for a person, with no training in the interpretation of ECG rhythms, to offer defibrillation therapy to victims of sudden cardiac arrest.
Technical Data Table 4: Applicable standards (continued) Table 7: Pediatric defibrillation pads (model XELAED003) Type Detail Parameter Detail Shipping and transportation ISTA Procedure 2A Type Sensitivity and specificity of Rhythm Detection • Shockable Rhythm—VF: Meets IEC 60601-2-4 requirement and AHA recommendation of Sensitivity of >90% • Shockable Rhythm—VT: Meets IEC 60601-2-4 requirement and AHA recommendation of Sensitivity of >75% • Non-shockable Rhythm—NSR: Meets IEC 60601-2-4 requireme
Technical Data B-4 70-01704-01 B Powerheart® G5 Automated External Defibrillator
C ECG Analysis Algorithm and Rescue Waveform Contents ◆ RHYTHMx® AED ECG analysis algorithm ................................... C-1 ◆ Rescue protocol ................................................................................. C-1 ◆ STAR® biphasic waveform .............................................................. C-1 This section describes the ECG analysis algorithm and Star Biphasic waveform.
ECG Analysis Algorithm and Rescue Waveform Waveform and energy levels for preinstalled defibrillation pads (Model number XELAED001) Waveform and energy levels for pediatric defibrillation pads Table C-1: Ultra-low variable energy waveform (all values are typical) Table C-4: Ultra-low variable energy waveform (all values are typical) Phase 1 Phase 2 Phase 1 Phase 2 Patient’s Impedance (Ohms) Voltage (Volts) (V1) Duration Voltage (ms) (Volts) (T1) (V2) Duration Energy (ms) (Joules) (T2) Patient’s
D Electromagnetic Emissions Standards Compliance Contents ◆ Guidance and manufacturer’s declaration—electromagnetic emissions ...................................D-1 ◆ Guidance and manufacturer’s declaration—electromagnetic immunity ...................................D-1 ◆ Recommended separation distances between portable and mobile RF communications equipment and the AED ..............................................................................................
Electromagnetic Emissions Standards Compliance Immunity test IEC 60601 test level Voltage dips, short interruptions and voltage variations on power supply input lines <5% UT (>95% dip in UT) for 0.5 cycle 61000-4-11 Compliance level Electromagnetic enviroment —guidance Not applicable 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec.
Electromagnetic Emissions Standards Compliance Recommended separation distances between portable and mobile RF communications equipment and the AED The AED is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Electromagnetic Emissions Standards Compliance D-4 70-01704-01 B Powerheart® G5 Automated External Defibrillator
E Waste Electrical and Electronic Equipment (WEEE) Directive Compliance Contents ◆ Manufacturer’s WEEE compliance instructions .......................E-1 Manufacturer’s WEEE compliance instructions Pursuant to European Community Directive 2002/96/EC (effective: February 2003), Cardiac Science Corporation is committed to minimizing the disposal of WEEE as unsorted municipal waste.
Waste Electrical and Electronic Equipment (WEEE) Directive Compliance E-2 70-01704-01 B Powerheart® G5 Automated External Defibrillator
F Limited Warranty Contents ◆ For how long?.......................................................................................F-1 ◆ What you must do:..............................................................................F-1 ◆ What we will do:...................................................................................F-1 ◆ Obligations and warranty limits:....................................................F-1 ◆ What this warranty does not cover:............................................
Limited Warranty YOUR EXCLUSIVE REMEDY WITH RESPECT TO ANY AND ALL LOSSES OR DAMAGES RESULTING FROM ANY CAUSE WHATSOEVER SHALL BE AS SPECIFIED ABOVE.
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Cardiac Science Corporation • N7 W22025 Johnson Drive, Waukesha, WI 53186 USA • 262-953-3500 • US toll-free 800-426-0337 • Fax: 262-953-3499 • care@cardiacscience.com Technical Support • (US) Fax: 262-798-5236 • techsupport@cardiacscience.com • (International) internationalservice@cardiacscience.com Cardiac Science, the Shielded Heart logo, Powerheart, STAR, Intellisense, Rescue Ready, RescueCoach, and RHYTHMx are trademarks of Cardiac Science Corporation. Copyright © 2015 Cardiac Science Corporation.
