Home

SURVIVALINK AED - Public Surplus

Contents

1. 81 Clinical Study Conclusion 0 0 llle esee 82 Section 8 Parts 8 Software 83 Standard Parts and Software ee eee 84 Model 9140 Standard 2 Year IntelliSense Battery 84 Defibrillation Electrodes 2020 cece eee 84 RescueLink Software Program eee eee 84 Serial Communication Cable a 84 RescueLink User Manual 84 Optional Parts and Software cece eee eee 85 Model 9141 5 Year IntelliSense Extended Life Battery 85 PCMCIA Card Adapter cee eee eee 85 300282 002 Rev EO 2002 Cardiac Science Inc Page 5 Table of Contents Rescue Data Storage Card ee 85 MDLink Options Card aaan 2c eee 85 MDLINK 3 struts quede us diss PDA SY wi edes 85 MDLink Manual 20 0000 cece es 85 Page 6 2002 Cardiac Science Inc 300282 002 Rev EO Section 1 Safety Overview This section presents safety information to guard against injury to persons and damage to the Survivalink AED The discussions are Dangers Cautions Warnings and Symbols Topic Page Safety Alert Definitions 8 Safety Alert Descriptions 9 Symbols Descriptions 12 300282 002 Rev EO 2002 Cardiac Science Inc Page 7 Section 1 Safety BB Safety Alert Definitions Before Operating the Survivalink AED Before operating the Survivalink AED become famili
2. eee 32 Survivalink AED Indicators 0 00002 34 Status Indicator 2 eee 34 Audible Maintenance Indicator a 34 Diagnostic Panel ce err eci cerre reide e e eee 34 SmartGauge Battery Status Indicator 35 Electrodes Indicator u 35 Service INdicatO o uuc dea u 35 Rescue Resume Button u 35 Rescue Indicator aaa 36 Resume Indicator llis 36 Text Display Optional enn 36 Section 4 Rescue 2 37 Voice Prompt and Text Display Descriptions 38 Pre Rescue Safety Information 0 0000 u 42 Performing the 66046 22 2 22222 22 eae 43 Place Electrodes 0 6 0 cee AG 43 Survivalink AED Analyzes Rhythm 2 0 44 Analyze Charge Defibrillation Shock 45 OPR MOJE ice Kainang a NAG UTIN ROS e bie dg 46 Repeat Analyze Charge Defibrillation Shock Sequence 46 Non Shockable Rhythm or Patient Converts toNSR 46 Transfer Patient to ALS Persomnel Aa 47 Post Rescue Process 2 1 0 0 0 48 Section 5 Data Management 49 Internal and External Data Storage Capacity 50 Survivalink AED Internal Storage Capacity 50 External Memory Storage 0 0 eee 50 Storing and Ret
3. CAUTION Temperature Humidity Pressure Extremes Exposing the Survivalink AED with the battery installed to extremes outside the following operation and standby conditions will cause the self tests to be disabled and could cause the Survivalink AED to function improperly Storing the Survivalink AED outside the stated temperature conditions for 5 consecutive days will result in a Service required alert Temperature 0 C to 50 C 32 F to 122 F Humidity 5 to 95 non condensing Pressure 57kPa 15 000 ft to 170kPa 15 000 ft 300282 002 Rev EO 2002 Cardiac Science Inc Page 11 Section 1 Safety Symbols Descriptions The following symbols may appear in this manual on the Survivalink AED or on its optional components Some of the symbols represent standards and compliances associated with the Survivalink AED and its use Dangerous Voltage The defibrillator output has high voltage and can present a shock hazard Please read and understand all safety alerts in this manual before attempting to operate the Survivalink AED Attention Identifies important information in this manual on the Survivalink AED or on its component parts regarding the safe and proper use of the Survivalink AED 7 Defibrillator Proof Type BF Equipment The Survivalink AED when connected to the patient s chest by the electrodes can withstand the effects of an externally applied defibrillation shock without diverting
4. Optional Parts and Software PCMCIA Card Adapter NS This adapter permits the use of a compact flash card in the type two or type three PCMCIA readers Rescue Data Storage Card Survivalink AED models 9110 9210 come equipped with a Rescue Data Card slot you can store the rescue data on a removable Rescue Data a Card Upon completing the rescue you can remove the card for data retrieval without taking the Survivalink AED out of use The Rescue Data Card stores ECG and other event data Using the MDLink Options Software and a Rescue Data Card you can program the Survivalink AED to record ECG event data along with the ambient sound at the rescue site The Rescue Data Card has eight megabytes MB of storage memory and is capable of recording up to ten hours of ECG and event data or up to 40 minutes with voice recording MDLink Options Card This card can be programmed with default and selectable software settings used to change the operation of the Survivalink AED using MDLink MDLink This program allows you to select several operating parameters and define identifiers for the Survivalink AED and its associated battery packs MDLink Manual This manual explains how to install and use the MDLink software 300282 002 Rev EO 2002 Cardiac Science Inc Page 85 Section 8 Parts amp Software Page 86 2002 Cardiac Science Inc 300282 002 Rev EO
5. QW IUE cce cp Verifying the Integrity of the Case Examine the molded case of the Survivalink AED for any visible signs of stress If the case shows signs of stress contact Technical Support at one of the following telephone numbers 888 466 8686 USA only 952 939 4181 USA and Canada 45 44 38 05 39 International Cleaning the Survivalink AED Case Gently clean the surface of the Survivalink AED case with a damp sponge or with a cloth and mild soap CAUTION Case Cleaning Solutions When disinfecting the case use a non oxidizing disinfectant such as ammonium salts or a gluteraldehyde based cleaning solution to avoid damage to the metal connectors Verifying the Time Clock At regular intervals verify the time on the Survivalink AED using RescueLink To adjust the internal clock follow the directions in the RescueLink User Manual 300282 002 Rev EO 2002 Cardiac Science Inc Page 57 Section 6 Maintenance amp Troubleshooting Repair Service and Service Indications Authorized Repair Service The Survivalink AED has no user serviceable internal components Try to resolve any maintenance issues with the Survivalink AED by using the Troubleshooting Table presented in this chapter If you are unable to resolve the problem contact Cardiac Science Technical Support for repair information at one of the following telephone numbers 888 466 8686 USA only 952 939 4181 USA and Canada 45 44 38
6. SURVIVALINK AED automated external defibrillator OPERATION amp SERVICE MANUAL 9200 9210 a Wu CARDIAC SCIENCE 0123 4 9100 9110 5 Year Limited Warranty What is Covered Cardiac Science Inc Cardiac Science warrants to the original purchaser that its products will be free of any defect in material and workmanship according to the terms and conditions of this Five year Limited Warranty For purposes of this Limited Warranty the original purchaser is deemed to be the original end user of the product purchased This Limited Warranty is NONTRANSFERABLE and UNASSIGNABLE For How Long Five 5 years from the date of original shipment to original purchaser for all products except those with a date expiration electrodes and lead acid batteries and lithium batteries Products with a date expiration shall be warranted until the expiration date Lithium batteries shall be warranted a shelf life of Five 5 years from date of shipment Lithium batteries shall be warranted for an operating life of Two 2 years from the date of installation into a Cardiac Science AED The terms of the Limited Warranty in effect as of the date of original purchase will apply to any warranty claims What You Must Do To qualify for this Limited Warranty the original purchaser must send the completed Warranty Validation Card within 30 days of original shipment to Cardiac Science Inc 5420 Feltl Road Minneapolis Minnesota 55343 T
7. flashing above the button and Hear the charged tone and Hear the voice prompt say Stand clear Press flashing button to rescue 10 Push the Rescue button to deliver the first defibrillation shock Note If you do not push the Rescue button within 30 seconds of hearing the prompt the Survivalink AED will disarm and re analyze the cardiac rhythm If a shockable rhythm is still detected the Stand clear Press flashing button to rescue prompt repeats If a shockable rhythm continues to be detected but the Rescue button is not pushed for approximately 2 1 2 minutes from the placement of electrodes or performing CPR the voice prompt will say Check pulse If no pulse give CPR Perform CPR if there is no pulse Analyze Charge Defibrillation Shock After the Survivalink AED delivers the first defibrillation shock the voice prompt will say Do not touch patient Analyzing rhythm The Survivalink AED analyzes the cardiac rhythm of the patient again If the Survivalink AED determines that a shockable cardiac rhythm still exists it will charge then issue another voice prompt instructing you to deliver another defibrillation shock 11 Push the Rescue button to deliver the second defibrillation shock Note The analyze charge defibrillation process will occur a maximum of three consecutive times 12 If at any time the patient has a non shockable cardiac rhythm the voice prompt will say Check pulse If
8. INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE Form Cardiac Science Five Year Limited Warranty CARDIAC SCIENCE SY Some states do not allow limitations on how long an implied warranty lasts so this limitation may not apply to you NO PERSON INCLUDING ANY AGENT DEALER OR REPRESENTATIVE OF CARDIAC SCIENCE IS AUTHORIZED TO MAKE ANY REPRESENTATION OR WARRANTY CONCERNING CARDIAC SCIENCE PRODUCTS EXCEPT TO REFER PURCHASERS TO THIS LIMITED WARRANTY YOUR EXCLUSIVE REMEDY WITH RESPECT TO ANY AND ALL LOSSES OR DAMAGES RESULTING FROM ANY CAUSE WHATSOEVER SHALL BE AS SPECIFIED ABOVE CARDIAC SCIENCE SHALL IN NO EVENT BE LIABLE FOR ANY CONSEQUENTIAL OR INCIDENTAL DAMAGES OF ANY KIND INCLUDING BUT NOT LIMITED TO EXEMPLARY DAMAGES COMMERCIAL LOSS FROM ANY CAUSE BUSINESS INTERRUPTION OF ANY NATURE LOSS OF PROFITS OR PERSONAL INJURY EVEN IF CARDIAC SCIENCE HAS BEEN ADVISED OF THE POSSIBILITIES OF SUCH DAMAGES HOWEVER OCCASIONED WHETHER BY NEGLIGENCE OR OTHERWISE Some states do not allow the exclusion or limitation of incidental or consequential damages so the above limitation or exclusion may not apply to you What This Warranty Does Not Cover This Limited Warranty does not cover defects or damages of any sort resulting from but not limited to accidents damage while in transit to our service location alterations unauthorized service unauthorized product case o
9. IntelliSense battery technology allows the Survivalink AED to determine battery capacity even if the battery is moved from one Survivalink AED unit to another Electrodes Proper electrode placement instructions appear on the electrodes and the electrode packaging Use the electrodes for one rescue only RescueReady Diagnostics Self Tests The Survivalink AED automatically performs a comprehensive self test of these internal parts Electronics Battery e Electrodes High voltage circuitry Maintenance Indicators When the Survivalink AED requires maintenance audible and or visible indicators will become active By monitoring these indicators you can be sure the Survivalink AED is ready to perform a rescue Rescue Data Management You can store rescue data in the internal memory of the Survivalink AED or externally on an optional Rescue Data Card with the Survivalink AED Models 9110 or 9210 Using Cardiac Science s RescueLink software program on your personal computer PC you can download the rescue data from the Survivalink AED s internal memory or from the Rescue Data Card to your PC You can then view store or print the data Text Display Optional Survivalink AED Models 9200 and 9210 can be equipped with a text display During a rescue the text display provides the rescuer with the voice prompts in written form elapsed time of rescue and number of Page 20 2002 Cardiac Science Inc 30028
10. LAN Minneapolis MN 55343 CARDIAC SCIENCE 800 991 Link N D 952 939 4181 952 939 4191 FAX Limited Warranty Validation Card Note This card must be returned in order to validate your limited warranty and to insure traceability Prior to usage of this product we recommend training for your personnel Please contact the sales representative or dealer from which you purchased this product to arrange training If you experience difficulty arranging training please contact us Model Number Serial Number Date of Purchase Purchased From Company Name Contact Person Street Address City State Zip Code Telephone Number Extended warranties are available Please contact your sales representative or dealer or Cardiac Science for the details FR996 regg NIN sijodeauuiy peod 1194 00179 9u BJUBNS DeINIeD AASSAYCV A8 Glvd 38 TIM ADVLSOd NIN SNDIdOH SEZ ON LIWAZd TIYN SSVTO LSYIJ Sa er o9 p o SS VW Alda SS3NISh8 SALVLS GALINA AHL NI G31IVW 41 AYVSSAOAN 3OVLSOd ON Survivalink AED Operation and Service Manual CAUTION Survivalink AED is intended for use by or on the order of a Physician or persons licensed by State law IMPORTANT Read this Operation and Service Manual carefully It contains information about your safety and the safety of others Become familiar with the controls and their proper use before operating the product The Surviv
11. 11 seconds to charge to its maximum energy after 15 maximum energy charges A battery with reduced capacity that causes the Replace indicator to initially turn ON typically takes 13 seconds to charge a fully discharged Survivalink AED to maximum energy The maximum time from Power On to Ready to Shock is 28 seconds The maximum time from Analyze to Ready to Shock is 22 seconds Delivery of Three Defibrillation Shocks Page 70 2002 Cardiac Science Inc 300282 002 Rev EO Section 7 Technical Data 55 seconds nominal Survivalink AED Self Test Sequence Frequency of Self Test What is Tested Daily Battery electrodes internal electronics rescue resume button and software Monthly every Battery under load electrodes internal electronics 28 days full energy charge cycle rescue resume button and software 300282 002 Rev EO 2002 Cardiac Science Inc Page 71 Section 7 Technical Data C 0123 MEDICAL ELECTRICAL EQUIPMENT 45i Safety and Performance Standards Survivalink AED Models 9100 9110 amp 9200 9210 The Survivalink AED has been designed and manufactured to conform to the highest standards of safety and performance including electromagnetic compatibility EMC The Survivalink AED Models 9100 9110 and 9200 9210 and electrodes conform to the applicable requirements of the following Classification IEC 601 1 defibril
12. 3 Setup AN A 12V C DATA D GND What You Should Know About the Batteries CAUTION Lithium Sulfur Dioxide Battery Pressurized contents never recharge short circuit puncture deform or expose to temperatures above 65 C 149 F Remove the battery when discharged Lithium Battery 1 E A Lot Option Exp Dere lt FIN EF L read et GNDO IE C IG N mo CS zmierni L D The unigue Cardiac Science IntelliSense battery technology means that vou will never be surprised during a rescue because of a depleted or dead battery Our IntelliSense batteries contain an integrated memory chip that automatically stores important usage information enabling the battery to maintain a complete history of its operation life This history includes Battery Identification Battery Type Original Date of Installation Number of Charges Completed Time in Operation hours minutes Days of Standby Operation Battery Capacity Remaining The IntelliSense battery technology offers you the most advanced battery capabilities available for defibrillators Future battery technologies may be incorporated by simply modifying the programming in the integrated memory chip This means that as battery technologies evolve Cardiac Science will be able to offer you the most current innovations 300282 002 Rev EO 2002 Cardiac Scie
13. 7 7 16 9210 3 55 kg 7 8 16 Operation and Standby Conditions Atmosphere Condition Temperature 0 C to 50 C 32 F to 122 F Humidity 5 to 95 non condensing Pressure 57kPa 15 000 ft to 170kPa 15 000 ft Shipment and Transport Conditions for up to 1 week Atmosphere Condition Temperature 40 C to 65 C 40 F to 149 F Temperature W Display 30 C to 65 C 22 C to 149 F 300282 002 Rev EO 2002 Cardiac Science Inc Page 69 Section 7 Technical Data Atmosphere Condition Humidity 5 to 95 non condensing Pressure 58kPa 15 000 ft to 170kPa 15 000 ft Electrodes ANSI DF 39 1993 Self adhesive disposable defibrillation electrodes Minimum combined surface area 228 cm Extended length of leadwire 1 0 m 1 3 m Lithium Battery Output Voltage and Extended Life Output Voltage for standard and extended life 12VDC max Extended life batteries are disposable and non rechargeable Lithium contents 13 2g max Expected Expected Typical Maximum Battery Operating Shelf Charges Charges Life Life at 20 C at 20 C 9141 Extended Life Lithium 5 years 5 years 300 365 Batteries and Capacitor Charge Times A fully charged battery typically takes 11 seconds to charge a fully discharged Survivalink AED to its maximum energy The Survivalink AED typically takes
14. AED 27 What You Should Know About the Batteries 29 What You Should Know About the Electrodes 32 Survivalink AED Indicators 34 300282 002 Rev EO 2002 Cardiac Science Inc Page 25 Section 3 Setup Unpacking and Inspecting Every attempt is made to ensure your order is accurate and complete However to be sure that your order is correct verify the contents of the box against your packing slip If you have any question about your order contact Cardiac Science Customer Service Department at 800 991 5465 or 952 939 4181 or your local Cardiac Science distributor Page 26 2002 Cardiac Science Inc 300282 002 Rev EO Section 3 Setup Survivalink AED The following drawings show the Survivalink AED parts and their locations A Lid B Latch push in amp up to open C Status indicator D Data access door E Battery compartment F Speaker G Electrode connector H Diagnostic panel I Card Slot models 9110 9210 J Serial communication port K Spare flash card storage L Text display available on models 9200D 9210D gt The term Survivalink AED refers to Models 9100 9110 and 9200 9210 The Survivalink AED will operate within a specified condition This range varies depending on whether the device is in Operating Standby or Storage Mode 300282 002 Rev EO 2002 Cardiac Science Inc Page 27 Section 3 Setup Operating Mode is defined as
15. American Heart Association AHA AED Task Force and approved by the AHA Science Advisory and Coordinating Committee 3 18 97 Table 2 Page 80 2002 Cardiac Science Inc 300282 002 Rev EO Section 7 Technical Data Clinical Study Summary Comparison of Survivalink s Biphasic and Monophasic Truncated Exponential Waveforms An IDE Clinical Study was performed The first shock efficacies of the control Monophasic truncated exponential waveforms were compared to the first shock efficacy of the Biphasic truncated exponential waveforms The study was divided into two sections The first section was a low energy section comparing a 200J low energy Monophasic versus a 2000 low current Biphasic The second section was a high energy section comparing a 360J high energy Monophasic versus a 300J high current Biphasic Each section was a prospective randomized blinded study designed with an independent group of patients for each section All patients undergoing procedures for electrophysiological testing or implantation of ICDs were invited to enroll in the study A total of 115 first shocks were delivered for both the Monophasic and Biphasic waveforms Of the 115 first shock attempts 60 were in the low energy arm and 55 in the high energy arm There were no adverse events associated with any of the treatments TABLE 1 Defibrillation Rate of Survivalink s Monophasic and Biphasic Waveforms Monophasi
16. Data Card two ways Inserting the Rescue Data Card into a compact flash card reader on a personal computer or Inserting the Rescue Data Card into the Survivalink AED card slot connecting the Survivalink AED to a PC using the serial communication cable and retrieving the data using RescueLink Once the rescue data has been retrieved erase the Rescue Data Card to prepare for the next rescue More information on retrieving and erasing data from a Rescue Data Card is in the RescueLink User Manual Page 52 2002 Cardiac Science Inc 300282 002 Rev EO Section 6Maintenance amp Troubleshooting Overview This section presents information about the Survivalink AED diagnostics self tests maintenance and service indications Topic Page Self Tests 54 Maintenance 56 Repair Service and Service Indications 58 Indicator Troubleshooting Table 59 Rescue Questions and Answers 60 Diagnostics Questions and Answers 62 Battery Questions and Answers 65 300282 002 Rev EO 2002 Cardiac Science Inc Page 53 Section 6 Maintenance amp Troubleshooting Self Tests The Survivalink AED has a comprehensive self test system that automatically tests to varying levels the electronics battery electrodes and high voltage circuitry daily and monthly Self tests are also activated every time you open and close the Survivalink AED lid Note On Survivalink AED s equipped with
17. in memory DATA IN MEMORY When all available memory sources are Do not push PUSH BUTTON TO full The YELLOW Resume indica Resume button CLEAR tor flashes and the phrase repeats until until data is down you download the data and clear mem loaded unless you ory press the Rescue Resume button must do a rescue or insert an empty Rescue Data Card Card full Storing CARD FULL When the optional Rescue Data Card internally STORING INTER installed in the Survivalink AED NALLY Model 9110 or 9210 is full The rescue data will be stored in the internal mem ory of the Survivalink AED Remove cable to REMOVE CABLE When a serial communication cable is continue rescue connected to the Survivalink AED dur ing a rescue the phrase repeats until the cable is disconnected Communications COMMUNICATIONS When the lid is open with a serial com Mode MODE munications cable plugged into the Survivalink AED Program Mode PROGRAM MODE One of the following When you install the MDLink Options Card before opening the lid and after opening the lid you immediately hold down the Rescue Resume button see MDLink manual When you are downloading the rescue event data from the internal memory of the Survivalink AED to a blank Rescue Data Card see Data Management section 2002 Cardiac Science Inc 300282 002 Rev EO Section 4 Rescue Voice Prompt Optional Text Display 9200 9210 Models only When
18. lid 4 Place the new electrodes in the storage space 5 Verify that the Replace indicator is not lit If it is replace the battery 6 Close the lid 7 Verify that the Status indicator on the Survivalink AED handle is GREEN 8 Retrieve the rescue data stored in the internal memory of the Survivalink AED or from a Rescue Data Card by using RescueLink installed on a PC Complete this step before the next rescue to prevent loss of rescue data After retrieving the rescue data erase the internal memory of the Survivalink AED or the Rescue Data Card before preparing for a new rescue as outlined in the RescueLink User Manual 9 Insert a blank Rescue Data Card into the Survivalink AED card slot Model 9110 or 9210 only Page 48 2002 Cardiac Science Inc 300282 002 Rev EO Section 5Data Management Overview This section presents information about the Survivalink AED Rescue Data Cards internal and external storage capacities and storing and retrieving rescue data Topic Page Internal and External Data Storage Capacity 50 Storing and Retrieving Rescue Data 51 300282 002 Rev EO 2002 Cardiac Science Inc Page 49 Section 5 Data Management Internal and External Data Storage Capacity Survivalink AED Internal Storage Capacity The Survivalink AED will automatically store internally up to 20 minutes of ECG and other rescue event data when no external memory
19. numbers are located on the bottom of the Survivalink AED Notice of Rights All rights reserved No part of this documentation may be reproduced or transmitted in any form by any means without the express written permission of Cardiac Science Inc Information in this documentation is subject to change without notice Names and data used in the examples are fictitious unless otherwise noted Defibrillator Tracking Defibrillator manufacturers and distributors are required under the Safe Medical Devices Act of 1990 to track the location of defibrillators they sell Please notify Survivalink Technical Support in the event that your defibrillator is sold donated lost stolen exported destroyed or if it was not purchased directly from Cardiac Science Inc Table of Contents Section 1 Safety 2 7 Safety Alert Definitions 0 0 0 2 eee 8 Before Operating the Survivalink AED 8 Safety Terms and DefinitionS 222 8 Safety Alert Descriptions 9 Symbols Descriptions 000 eee 12 Section 2 Introduction 17 Survivalink AED 022 es 18 Survivalink AED Description 020202020 18 Survivalink AED Rescue Sequence 2 18 Survivalink AED Parts and Features ullius 20 IntelliSense
20. the Survivalink AED To place an order call Cardiac Science customer service at 800 991 5465 or 952 939 4181 Fax 952 939 4191 Topic Page Standard Parts and Software 84 Optional Parts and Software 85 300282 002 Rev EO 2002 Cardiac Science Inc Page 83 Section 8 Parts amp Software Standard Parts and Software Defibrillation Electrodes U Model 9130 Two Year Defibrillation Electrodes lt lt Z Model 9610 One Year Pacing Monitoring Defibrillation Electrodes The adhesive backed electrodes with an attached cable and connector come in a sealed package ready to use RescueLink Software Program This software allows you to transfer view and store rescue data recorded by the Survivalink AED You can transfer the data from the Survivalink AED to your personal computer where you can print out the data You can also set the Survivalink AED s internal clock using this software Serial Communication Cable This cable connects the Survivalink AED to your PC for downloading rescue data The gray nine pin connector plugs into the PC and the other end plugs into the Survivalink AED Model 9141 IntelliSense Extended Life Battery This extended life battery installed in Survivalink AED operates for up to 5 years in Standby mode or can typically deliver 300 shocks before requiring replacement Page 84 2002 Cardiac Science Inc 300282 002 Rev EO Section 8 Parts amp Software
21. the shock from the patient or into the Survivalink AED CE Mark This equipment conforms to essential requirements of the Medical Device Directive 93 42 EEC 0123 IP23 The Survivalink AED is protected against the effects of spraying water in accordance with IEC 529 NUS Classified by Underwriters Laboratories Inc with respect to electric shock fire and mechanical hazards only in accordance with UL 2601 1 C US and IEC 601 2 4 IEC SC 62D WG2 O Dowd and CAN CSA C22 2 No 601 1 M90 MEDICAL ELECTRICAL EQUIPMENT 45 International symbol for ON Open the lid to turn ON the Survivalink AED Page 12 2002 Cardiac Science Inc 300282 002 Rev EO Section 1 Safety TSO C97 P om RESCUE OQ RESUME FAA TSO marking This battery conforms to the FAA lithium sulfer dioxide batteries technical standard order TSO C97 International symbol for OFF Close the lid to turn OFF the Survivalink AED Open the lid to turn ON the Survivalink AED Indicates the Survivalink AED battery status The shaded areas indicate the remaining battery capacity Check the electrodes The electrodes are either missing or out of specification Also on the electrode packaging this symbol represents one pair Indicates Survivalink AED requires maintenance by authorized service personnel When lit push this button to deliver a defibrillation shock When lit push this button to clear the internal memory to allow sto
22. the Survivalink AED only for emergency treatment of sudden cardiac arrest if the patient Is unconscious Is not breathing Has no pulse What are the Contraindications for Use Do not use the Survivalink AED for emergency treatment if the patient s conscious or s breathing or e Has a pulse or s under eight years of age 4 American Heart Association Advance Cardiac Life Support edited by R O Cummins page 4 11 1994 Page 22 2002 Cardiac Science Inc 300282 002 Rev EO Section 2 Introduction Survivalink AED Operator Training Requirements Persons authorized to operate the Survivalink AED must have all of the following minimum training and experience CPR certification Defibrillation training and other training as required by state province or country regulations Survivalink AED training before use in an actual rescue Additional training as required by the Medical Director A thorough understanding of the procedures in this manual gt Keep certificates of training and certification as reguired by state province or country regulations 300282 002 Rev EO 2002 Cardiac Science Inc Page 23 Section 2 Introduction Page 24 2002 Cardiac Science Inc 300282 002 Rev EO Section 3 Setu p Overview This section presents information on unpacking and setting up the Survivalink AED Topic Page Unpacking and Inspecting 26 Survivalink
23. the Survivalink AED recommends a defibrillation shock When a defibrillation shock is advised you determine if or when to deliver the shock Cardiac Rhythms Used to Test the Rhythm Recognition Detection System for Survivalink AED Models 9100 9110 Rhythm Class Models ECG Specifications Test Sample Size Shockable 9100 9110 304 Survivalink AED meets the AAMI Rhythm VF 9200 9210 318 DF39 requirement and AHA rec ommendation of Sensitivity gt 90 Shockable 9100 9110 12 Survivalink AED meets the AAMI Rhythm VT 9200 9210 53 DF39 requirement and AHA rec ommendation of Sensitivity gt 75 Non shockable 9100 9110 1082 Survivalink AED meets the AAMI rhythm Normal DF39 reguirement of Specificity gt 9200 9210 1207 Sinus Rhythms 95 and AHA recommendation of Specificity gt 99 Non shockable 9100 9110 10 Survivalink AED meets the AAMI rhythm Asys 9200 9210 16 DF39 Fequirstient and the AHA tole recommendation of Specificity 5 95 Non shockable 9100 9110 1729 Survivalink AED meets the AAMI rhythm all other 9200 9210 2363 DF39 requirement and AHA rec non shockable rhythms ommendation of Specificity gt 95 a From Survivalink ECG rhythm databases b Automatic External Defibrillators for Public Access Defibrillation Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance Incorporating New Waveforms and Enhancing Safety
24. the following a Make sure the electrodes are firmly placed on clean dry skin b Electrode cables are securely plugged into the Survivalink AED Energy can only be delivered to the electrodes after the electrodes are properly placed the Rescue indicator is flashing and the Survivalink AED is sounding a continuous charged tone Ensure the patient is not being moved while the Survivalink AED is analyzing because this may cause incorrect rhythm analysis Survivalink AED Analyzes Rhythm As soon as the Survivalink AED detects proper electrode placement the voice prompt will say Do not touch patient Analyzing rhythm The Survivalink AED will begin to analyze the cardiac rhythm of the patient Page 44 2002 Cardiac Science Inc 300282 002 Rev EO Section 4 Rescue RESCUE O a Ifthe Survivalink AED detects a shockable cardiac rhythm the voice prompt will say Charging and the Survivalink AED prepares to deliver a defibrillation shock b Ifthe Survivalink AED does not detect a shockable rhythm the voice prompt will say Check pulse If no pulse give CPR Note If the Asystole prompt has been enabled using MDLink and the Survivalink AED detects Asystole you will hear the Asystole voice prompt before the Check pulse If no pulse give CPR voice prompt See the MDLink Manual When the Survivalink AED is ready to deliver a defibrillation shock you will See the word Rescue
25. them from the Survivalink AED and placing them inside your coat 300282 002 Rev EO 2002 Cardiac Science Inc Page 65 Section 6 Maintenance amp Troubleshooting Page 66 2002 Cardiac Science Inc 300282 002 Rev EO Section 7 Technical Data Overview This section presents technical data about the Survivalink AED Topic Page Parameters 68 Safety and Performance Standards 72 Clinical Study Summary 81 300282 002 Rev EO 2002 Cardiac Science Inc Page67 Section 7 Technical Data Parameters Operation Semi automatic shock advisory Audible Alerts Voice prompt Charged tone Maintenance alert Card insert alert Visible Indicators Status indicator Battery status indicators Service indicator Electrodes indicator Optional Text Display Rescue Data Storage Storage Capacity Internal 20 minutes ECG data with event annotation External With 8 MB minimum Rescue Data Card option Removable 40 minutes ECG with voice and event annotation e Ten hours continuous ECG data with event annotation Page 68 2002 Cardiac Science Inc 300282 002 Rev EO Section 7 Technical Data Dimensions Measurement Dimension Height 8 cm 3 3 in Width 27 cm 10 6 in Depth 31 cm 12 4 in Weight Model Weight with Batteries and Electrodes 9100 3 36 kg 7 4 Ib 9110 3 41 kg 7 5 Ib 9200 3 50 kg
26. 05 39 International Warning Shock hazard Do not disassemble the Survivalink AED Failure to observe this warning can result in personal injury or death Refer maintenance issues to Cardiac Science authorized service personnel gt The warranty will be void upon unauthorized disassembly or service of the Survivalink AED Service Indications The Survivalink AED is designed to be reliable and easy to maintain When the Survivalink AED requires maintenance the Status indicator turns RED and or an audible maintenance alert will sound Lift the lid and note which indicator s is lit Use the Troubleshooting Table to determine the maintenance requirement Page 58 2002 Cardiac Science Inc 300282 002 Rev EO Section 6 Maintenance amp Troubleshooting Indicator Troubleshooting Table The following is a troubleshooting table for the Survivalink AED indicators Symptom Solution EHI gt RED Service indicator LED Maintenance by authorized service is lit personnel is required Call Cardiac Science Technical Support at 888 466 8686 USA only or 952 939 4181 USA and Canada or 45 44 38 05 39 International LI m RED Electrodes indicator LED is lit Connect the electrodes or replace with a new pair Battery Replace indicator LED is RED The battery is low Replace with a new battery Status indicator is RED and no other indicators on the
27. 2 002 Rev EO Section 7 Technical Data Survivalink AED Models 9100 9110 Waveform AAMI DF 2 1996 Section 4 3 4 2 truncated exponential 2500 2000 Output 4500 Voltage V 1000 500 10 15 Time ms 200 Joule Survivalink AED Models 9100 9110 Waveform all values are typical Patients Impedance Ohms Voltage Volts Duration ms 25 1900 3 0 50 1900 4 0 72 1900 6 1 100 1900 8 1 125 1900 10 1 300 Joule Survivalink AED Models 9100 9110 Waveform all values are typical Patients Impedance Ohms Voltage Volts Duration ms 25 2000 3 5 50 2000 6 9 75 2000 10 4 100 2000 13 9 125 2350 9 8 300282 002 Rev EO 2002 Cardiac Science Inc Page 75 Section 7 Technical Data 360 Joule Survivalink AED Models 9100 9110 Waveform all values are typical Patients Impedance Ohms Voltage Volts Duration ms 25 2000 5 8 50 2000 11 5 75 2000 17 3 100 2000 23 0 125 2350 13 2 Energy Levels and Patient Impedance The Survivalink AED Monophasic Truncated Exponential MTE waveform has energy levels of 200 J 300 J 360 J 15 at 50 Ohms patient impedance This allows for escalating energies of subsequent shocks The automatic waveform correction for patient impedance is shown in the preceding Survivalink AED Models 9100 9110 Waveform tables Page 76 2002 Cardiac Science Inc 3002
28. 2 002 Rev EO Section 2 Introduction shocks delivered The text screen also provides instruction during service mode Internal Clock Survivalink AED s internal clock is used to record the time of all significant rescue events The internal clock is set using the RescueLink software program The internal clock will automatically adjust itself for daylight savings time leap years etc The daylight savings time feature can be disabled with MDLink 300282 002 Rev EO 2002 Cardiac Science Inc Page 21 Section 2 Introduction Survivalink AED Operators and Indications for Use Who Can Use the Survivalink AED After meeting the Survivalink AED training requirements the following persons qualify to operate the Survivalink AED Physicians or persons authorized by state province or country regulations in which they practice Persons trained in basic life support advanced cardiac life support or emergency medical response while under the direction of a Physician What is the Operator s Responsibility The operator is responsible for the safe and effective use of the Survivalink AED and its accessories This involves Following the safety alerts and operating procedures in this manual Following maintenance schedules and operating procedures for the Survivalink AED and its accessories Obtaining training in the use of the Survivalink AED and its accessories What are the Indications for Use Use
29. 200 9210 RTCA DO 199 Section 6 2 1 during analysis only Immunity Field Models Standard or Compliance E M 9100 9110 IEC 801 3 1984 Level 3 9200 9210 EN 61000 4 3 Level 3 Magnetic 9100 9110 MIL STD 462D Method RS101 9200 9210 EN 61000 4 8 80A m for 47 5Hz 1320Hz ESD 9100 9110 IEC 801 2 1991 Level 2 9200 9210 EN 61000 4 2 Level 2 300282 002 Rev EO 2002 Cardiac Science Inc Page 73 Section 7 Technical Data Environmental Conditions Condition Models Standard or Compliance Temperature 9100 9110 RTCA DO 160D Section 4 Category Altitude 9200 9210 A4 Operating 0 C to 50 C Ground Sur Decompres vival 0 C to 50 C sion Overpres sure Temperature 9200 9210 RTCA DO 160D Section 5 Category C Variation Free Fall Drop 9100 9110 IEC 68 2 32 1975 1 meter 9200 9210 Shock Bump 9100 9110 IEC 68 2 29 25g and 6000 bumps 9200 9210 IEC 68 2 29 40g and 6000 bumps Vibration 9100 9110 RTCA DO 160D Section 8 Category S Random 9200 9210 9200 9210 IEC 68 2 64 10Hz 2kHz at 0 0500 0 0012 g2 Hz Vibration 9100 9110 IEC 68 2 6 10Hz 40 7Hz at 0 15 mm Sine and 40 7Hz 150Hz at 1g 9200 9210 IEC 68 2 6 10Hz 57 6Hz at 0 15 mm and 57 6Hz 150Hz at 2g Enclosure Pro 9100 9110 IEC 529 IP23 tection 9200 9210 Shipping and Transport Conditions ASTM D4169 92 2002 Cardiac Science Inc 30028
30. 82 002 Rev EO Section 7 Technical Data Survivalink AED Models 9200 9210 Waveform AAMI DF 2 1996 Section 4 3 4 3 other waveforms 1 Output Voltage 500 V 2500 PONG ns es Ka ce nct UE M AE 1500 000 0 500 4 1000 1500 Time ms Low Current Survivalink AED Models 9200 9210 Waveform all values are typical Phase 1 Phase 2 Patient s Impedance Voltage Duration Voltage Duration Energy Ohms Volts ms Volts ms Joules 25 1570 3 3 825 3 2 180 250 50 1600 4 5 1031 3 2 170 220 75 1620 5 8 1111 3 2 150 210 100 1630 7 0 1158 3 2 140 190 125 1650 8 3 1193 3 2 140 190 High Current Survivalink AED Models 9200 9210 Waveform all values are typical Phase 1 Phase 2 Patient s Impedance Voltage Duration Voltage Duration Energy Ohms Volts ms Volts ms Joules 25 1890 3 3 993 32 270 360 50 1920 4 5 1238 32 240 320 300282 002 Rev EO 2002 Cardiac Science Inc Page 77 Section 7 Technical Data Phase 1 Phase 2 Patient s Impedance Voltage Duration Voltage Duration Energy Ohms Volts ms Volts ms Joules 75 1930 5 8 1324 3 2 220 290 100 1940 7 0 1379 3 2 200 270 125 1950 8 3 1410 3 2 190 260 Energy Levels and Patient Impedance The Survivalink Biphasic Truncated Exponential BTE waveform utilizes varia
31. Battery 0 0 0 cee ee 20 Electrodes 5 ooi aed AN Dee 20 RescueReady Diagnostics Self Tests 20 Maintenance Indicators cee eee eee 20 Rescue Data Management 00 eee eee 20 Text Display Optional leeren 20 Internal Clock 0000 cee eee 21 Survivalink AED Operators and Indications for Use 22 Who Can Use the Survivalink AED 22 What is the Operator s Responsibility 22 What are the Indications for Use 4 22 What are the Contraindications for Use 22 Survivalink AED Operator Training Requirements 23 Section 3 Setup 2 25 Unpacking and Inspecting 26 Survivalink AED 4 4 7 3 Ka ADA Gand edad id beds 27 Survivalink AED Operating and Standby Conditions 28 Survivalink AED Shipping and Transport Conditions 28 What You Should Know About the Batteries 29 Lithium Battery 29 Battery Life oci see ee eee bees AA 30 Battery Shelf Life 30 To Install the Battery 31 300282 002 Rev EO 2002 Cardiac Science Inc Page 3 Table of Contents Activating the Survivalink AED Self Tests 31 What You Should Know About the Electrodes 32 To Install the Electrodes 0 0
32. EO 2002 Cardiac Science Inc Page 41 Section 4 Rescue AN AN Pre Rescue Safety Information The following cautions must be observed to prevent problems during the rescue CAUTION Fire and Explosion Hazard Exercise caution when operating the Survivalink AED close to flammable gases including concentrated oxygen to avoid possible explosion or fire hazard CAUTION Possible Radio Frequency RF Susceptibility RF susceptibility from cellular telephones CB radios and FM 2 way radio may cause incorrect rhythm recognition and a subsequent shock advisory When attempting a rescue using the Survivalink AED do not operate wireless radiotelephones within one meter of the Survivalink AED turn power OFF to the radiotelephone and other like equipment near the incident CAUTION Possible Improper AED Performance The Survivalink AED will not function during a rescue when the serial communication cable is connected to its serial port When the serial communication cable is connected to the Survivalink AED during a rescue the prompt will say Remove cable to continue rescue until you remove the serial communication cable from the Survivalink AED CAUTION Possible Interference With Implanted Pacemaker The Survivalink AED may not advise a defibrillation shock when the patient has an implanted pacemaker However a defibrillation attempt should be made if the patient Is unconscious and s not breathing an
33. Press the Resume button to clear the internal memory and continue or insert a blank Rescue Data Card before placing the electrodes 300282 002 Rev EO 2002 Cardiac Science Inc Page 51 Section 5 Data Management Data Access Door Card Slot Transferring Data to a Rescue Data Card Rescue data can be transferred from the Survivalink AED s internal memory to a blank Rescue Data Card To transfer the rescue data from internal memory to a rescue data card 1 Close the Survivalink AED lid 2 Open the data access door 3 Insert a blank Rescue Data Card into the card slot 4 Open the lid 5 Hold down the Rescue Resume button When the GREEN Battery Status indicators begin to rapidly sequence the rescue data will transfer the from the Survivalink AED s internal memory to the Rescue Data Card The voice prompt will say Program mode Note While transferring data to a rescue card Survivalink AEDs equipped with the optional text display will display the following COPYING DATA TO CARD To prevent loss of data press the Rescue Resume button only while the Battery Status indicators are sequencing 6 When the data transfer is complete the voice prompt will say Card full Storing internally Remove the Rescue Data Card from the card slot 7 Close the lid and data access door Retrieving Data From a Rescue Data Card You can retrieve rescue data from a Rescue
34. You Will Hear the Prompt Audible alerts Two Tone Beep occurs after insert ing an optional Rescue data card or a MDLink options card into the Surviv alink AED s card slot with the lid open Also occurs in 15 second inter vals during CPR when enabled by the MDLink software program Warble Beep occurs when the Sur vivalink AED requires maintenance Press flashing but ton to continue rescue PRESS BUTTON TO CONTINUE RESCUE When you open the Survivalink AED lid and the electrodes are attached to the patient and connected to the Surviv alink AED The YELLOW Resume indicator flashes and the phrase will repeat until you press the Rescue Resume button Continue CPR CPR X XX Phrase repeats in 15 second intervals during CPR mode You can enable the Continue CPR prompt using the MDLink software program Asystole ASYSTOLE Occurs when the Survivalink AED detects Asystole during ECG analy sis You can enable the Asystole prompt using the MDLink software program Service required SERVICE REQUIRED Occurs when the self tests determine that the Survivalink AED is not func tioning properly The RED Service indicator will illu minate and Service required will repeat until you close the lid After closing the lid a warble beep will be heard until the battery is removed or becomes completely depleted 300282 002 Rev
35. alink AED Models 9100 9110 9200 9210 are manufactured by Manufacturer Survivalink Corporation wholly owned subsidiary of Cardiac Science Inc 5420 Feltl Road Minneapolis MN 55343 7982 Authorized European Representative Cardiac Science International Kirke Vaerloesevej 14 3500 Vaerloese Denmark Trademark Information Survivalink MDLink SmartGauge STAR IntelliSense RescueReady and RescueLink are trademarks and registered trademarks of Cardiac Science Inc Microsoft and Windows are registered trademarks of Microsoft Corporation COMPACTFLASH is a trademark of SanDisk Corporation Limited Warranty The Survivalink AED Operation and Service Manual and any and all information contained herein does not constitute any warranty as to the Survivalink AED or any related products in any manner whatsoever The Limited Warranty is shipped with the Survivalink AED products and serves as the sole and exclusive warranty provided by Cardiac Science regarding the Survivalink AED Customer Service For Customer Service call 800 991 5465 952 939 4181 952 939 4191 fax Technical Support For 24 hour service contact Technical Support at 888 466 8686 USA only 952 939 4181 USA and Canada 952 939 4191 fax 45 44 38 05 39 International There is no charge to the customer for a Technical Support call Please have the serial and model numbers available when contacting Technical Support The serial and model
36. ar with the various safety alerts in this section Safety alerts identify potential hazards using symbols and words to explain what could potentially harm you the patient or the Survivalink AED Safety Terms and Definitions The triangle attention symbol shown below left identifies the potential hazard categories The definition of each category is as follows DANGER This alert identifies hazards that will cause serious personal injury or death WARNING This alert identifies hazards that may cause serious personal injury or death CAUTION This alert identifies hazards that may cause minor personal injury product damage or property damage The term Survivalink AED refers to Models 9100 9110 amp 9200 9210 Page 8 2002 Cardiac Science Inc 300282 002 Rev EO Section 1 Safety AN AN gt po p Safety Alert Descriptions The following is a list of Survivalink AED safety alerts that appear in this section and throughout this manual You must read understand and heed these safety alerts before attempting to operate the Survivalink AED DANGER Fire and Explosion Hazard Exercise caution when operating the Survivalink AED close to flammable gases including concentrated oxygen to avoid possible explosion or fire hazard WARNING Shock Hazard Defibrillation shock current flowing through unwanted pathways is potentially a serious electrical shock hazard To avoid this hazard during defibrillat
37. ardia cardiac rhythm rate is at least 180 bpm Supraventricular tachycardia cardiac rhythm rate is at least 180 bpm The Survivalink AED uses one button for all operations It also guides you through the rescue using a combination of voice prompts audible alerts and visible indicators Survivalink AED Rescue Sequence The Survivalink AED rescue sequence is consistent with the guidelines recommended by the American Heart Association AHA and the European CPR Guidelines or Universal ALS European Precool Upon detecting a shockable cardiac rhythm the Survivalink AED advises you to press the Rescue button to deliver a series of up to three 3 defibrillation shocks followed by performing one minute of CPR The Survivalink AED will prompt for one 1 minute of CPR per AHA Guidelines Note The European CPR Protocol can be enabled using Cardiac Science s MDLink software All units shipped to European countries that follow the European Resuscitation Council s guidelines will have this option enabled at the factory When enabled three 3 minutes of CPR will be administered if the first analysis decision is non shockable or following two consecutive non shockable analysis decisions 1 Guidelines for Cardiopulmonary Resuscitation and Emergency Care Journal of the American Medical Associa tion Oct 28 1992 Vol 268 No 16 2211 2212 2 Defibrillation In Cummins R ed Advanced Cardiac Life Suppor
38. ble energy The precise energy delivered will vary with the patient s impedance Energy will be delivered at two different levels referred to as low current and high current as shown in the preceding Survivalink AED Models 9200 9210 Waveform tables This allows for escalating energies of subsequent shocks 1 Survivalink AED Models 9200 9210 The low current and high current shocks are variable energy The actual energy is determined by the patient s impedance Page 78 2002 Cardiac Science Inc 300282 002 Rev EO Section 7 Technical Data Rhythm Recognition Detection System The Survivalink AED Rhythm Recognition Detection system analyzes the patient s ECG and advises you when the Survivalink AED detects a shockable or non shockable rhythm This system makes it possible for a person with no training in the interpretation of ECG rhythms to offer defibrillation therapy to victims of ventricular fibrillation pulseless ventricular tachycardia or pulseless supraventricular tachycardia The Survivalink AED Rhythm Recognition Detection System contains Electrode contact determination Automated interpretation of the ECG Operator control of defibrillation shock therapy The transthoracic impedance of the patient is measured through the defibrillation electrodes When the baseline impedance is higher than a maximum limit the Survivalink AED determines that the electrodes are not in sufficient contact with the patient or a
39. c Biphasic Statistical Waveform Waveform Analysis Overall First Shock Success n 115 97 4 100 p 0 0001 95 Confidence Interval 94 5 100 100 Low Energy First Shock Success n 604 96 7 100 p 0 002 95 Confidence Interval 92 2 100 100 High Energy First Shock Success n 55 98 2 100 p 0 0001 95 Confidence Interval 94 7 100 100 highly statistically significant Survivalink AED Models 9200 9210 The low current and high current shocks are variable energy The actual energy is determined by the patient s impedance 300282 002 Rev EO 2002 Cardiac Science Inc Page 81 Section 7 Technical Data Clinical Study Conclusion The overall efficacy rate of Survivalink s Biphasic waveform is equivalent to the overall efficacy rate of Survivalink s Monophasic waveform The efficacy rates of the stacked shock sequence of Survivalink s Biphasic waveform are equivalent to the Survivalink AED Monophasic waveform stacked shock sequence Monophasic stacked shock sequence 200J 300J 360J is equivalent to the Biphasic 200J 300J 300J stacked shock sequence Monophasic stacked shock sequence 360J 360J 360J is equivalent to the Biphasic 300J 300J 300 stacked shock sequence Page 82 2002 Cardiac Science Inc 300282 002 Rev EO Section 8 Parts amp Software Overview This section presents standard and optional parts and software for
40. d Has no pulse Placing Electrodes Do not place the electrodes directly over an implanted device Place the electrode pad at least one inch from any implanted device 1 Cummins R ed Advanced Cardiac Life Support AHA 1994 Ch 4 Page 42 2002 Cardiac Science Inc 300282 002 Rev EO Section 4 Rescue Performing the Rescue Assess the Patient 1 Determine that the patient is over 8 years of age and exhibits all of the following Unconscious Not breathing Has no pulse 2 Turn the Survivalink AED ON by pushing the lid s release button In and Up to open the lid The LEDs on the diagnostic panel will sequence On and Off until the self test is completed at which time the voice prompt will say Place Electrodes D ngg e c If you close the lid during a rescue you must re open the lid within 15 seconds to continue the rescue Ifthe lid remains closed for more than 15 seconds a new rescue will initiate when the lid is re opened Note During a rescue the text display provides the rescuer with the voice prompts in written form elapsed time of rescue and number of shocks delivered For a complete description of displayed text see Voice Prompt and Text Display Descriptions on page 36 Place Electrodes A 3 With the electrodes connected to the Survivalink AED as shown in the drawing tear the outer electrode package along the dotted line and pull the el
41. diag nostic panel are lit The battery power is completely depleted Replace with a new bat tery 300282 002 Rev EO 2002 Cardiac Science Inc Page 59 Section 6 Maintenance amp Troubleshooting Rescue Questions and Answers The following table answers frequently asked questions about the Rescue Questions and Answers Can I skip the CPR mode No CPR is a very important part of the optimal resuscitation protocol gt OI O Can I give CPR while the Survivalink AED is analyzing No As with all AEDs the rescuer should stop CPR compressions during the analy sis phase CPR may interfere with the analysis of the cardiac rhythm we gt Can I transport the victim while the Survivalink AED is analyzing No Vehicle motion may cause noise artifacts that could interfere with proper car diac rhythm analysis Stop the vehicle when cardiac rhythm analysis is necessary When will the Survivalink AED prompt for CPR The Survivalink AED will prompt for CPR e After the Survivalink AED delivers 3 consecutive defibrillation shocks or After the Survivalink AED detects a non shockable cardiac rhythm during cardiac rhythm analysis or When the Survivalink AED detects a shockable cardiac rhythm but the Rescue button is not pushed for approximately 2 1 2 minutes from the placement of electrodes on the patient or after performing CPR Do I need to prepare the chest prior to electr
42. e disabled and could cause the Survivalink AED to function Page 54 2002 Cardiac Science Inc 300282 002 Rev EO Section 6 Maintenance amp Troubleshooting improperly Storing the Survivalink AED outside these conditions for 5 consecutive days will result in a service required alert Temperature 0 C to 50 C 32 F to 122 F Humidity 5 to 95 non condensing Pressure 57kPa 15 000 ft to 170kPa 15 000 ft Daily Self Test Every day at 3 03 03 a m the daily self test occurs checking the battery electrodes electronics Rescue Resume button and the software These components are also tested each time you open and close the Survivalink AED lid Monthly Self Tests A full charge is discharged internally to test the high voltage circuitry This additional test occurs every 28 days when the daily self test occurs 300282 002 Rev EO 2002 Cardiac Science Inc Page 55 Section 6 Maintenance amp Troubleshooting JM Maintenance Daily Perform the following test daily to confirm that the Survivalink AED RescueReady diagnostics are functioning properly Check the Status indicator to ensure that it is GREEN When the indicator is GREEN the Survivalink AED is ready for a rescue If the indicator turns RED refer to the Troubleshooting Table in this chapter Performing the Annual Maintenance Perform the following tests annually to confirm that the Survivali
43. ectrodes from the package Leave the package attached to the electrode wires L Before placing electrodes remove the chest clothing of the patient gt exposing the bare skin Prepare the chest of the patient as directed by the medical director and make sure the skin 16 as clean dry and oil free as practical 300282 002 Rev EO 2002 Cardiac Science Inc Page 43 Section 4 Rescue Note The electrodes are self adhesive and ready to apply 5 With a firm steady pull carefully peel one electrode away from the release liner 6 Place the electrode with the adhesive side on the patient s skin on the upper right chest placing the top of the electrode on the collarbone as shown in the drawing Avoid placing the electrode directly over the sternum 7 With a firm steady pull carefully peel the other electrode away from the release liner 8 Place the other electrode on the lower left chest placing the bottom on the lower margin of the rib cage Note Standard defibrillation electrodes can be placed in either position as shown on the electrode package When using pacing monitoring electrodes refer to the placement instructions on the pacing monitoring electrode package 9 When the electrodes are placed the voice prompt will say Do not touch patient Analyzing rhythm If the electrodes become disconnected from the Survivalink AED or the patient the voice prompt will say Check electrodes Check
44. g the rescue CAUTION Use only Survivalink Approved Equipment Using batteries electrodes cables or optional equipment other than those approved by Survivalink may cause the Survivalink AED to function improperly during a rescue CAUTION Serial Communications Cable The Survivalink AED will not perform a rescue when a serial communication cable is connected to its serial connector The voice prompt will say remove cable to continue rescue CAUTION Possible Interference With Implanted Pacemaker The Survivalink AED may not advise a defibrillation shock when the patient has an implanted pacemaker However a defibrillation attempt should be made if the patient s unconscious and s not breathing and Has no pulse Placing Electrodes Do not place the electrodes directly over an implanted device Place the electrode pad at least one inch from any implanted device CAUTION Lithium Sulfer Dioxide Battery Pressurized contents never recharge short circuit puncture deform or expose to temperatures above 65 C 149 F Remove the battery when discharged CAUTION Battery Disposal Recycle or dispose of the lithium battery in accordance with all federal state and local laws To avoid fire and explosion hazard do not burn or incinerate the battery 1 Cummins R ed Advanced Cardiac Life Support AHA 1994 Ch 4 Page 10 2002 Cardiac Science Inc 300282 002 Rev EO Section 1 Safety
45. having the battery installed and the lid open This is the mode it would be in during an actual rescue situation Standby Mode is when the battery is installed but the lid is closed This is the normal mode for the Survivalink AED to be in between rescues In this mode the device will conduct its routine self tests to determine that it is operating correctly Storage Mode is when the battery is removed such as during shipping or transport With the battery removed the Survivalink AED is unable to perform self tests or rescues Survivalink AED Operating and Standby Conditions Temperature 0 C to 50 C 32 F to 122 F Humidity 5 to 95 non condensing Atmospheric Pressure 57kPa to 170kPa CAUTION Temperature Humidity Pressure Extremes Exposing the Survivalink AED with the battery installed to extremes outside the operation and standby conditions will cause the self tests to be disabled and could cause the Survivalink AED to function improperly Storing the Survivalink AED outside these conditions for 5 consecutive days will result in a service required alert Survivalink AED Shipping and Transport Conditions for up to 1 week Temperature 40 C to 65 C 40 F to 149 F Temperature W Display 30 C to 65 C 22 F to 149 F Humidity 5 to 95 non condensing Atmospheric Pressure 57kPa to 170kPa Page 28 2002 Cardiac Science Inc 300282 002 Rev EO Section
46. ion abide by all of the following Do not touch the patient unless performance of CPR in indicated Do not touch metal objects in contact with the patient Keep defibrillation electrodes clear of other electrodes or metal parts in contact with the patient Disconnect all non defibrillator proof equipment from the patient before defibrillation WARNING Shock and Possible Equipment Damage Disconnect all non defibrillator proof equipment from the patient before defibrillation to prevent electrical shock and potential damage to the equipment WARNING Battery is Not Rechargeable Do not attempt to recharge the battery Any attempt to recharge the battery may result in an explosion or fire hazard CAUTION Possible Radio Frequency RF Susceptibility RF susceptibility from cellular telephones CB radios and FM 2 way radio may cause incorrect rhythm recognition and subsequent shock advisory When attempting a rescue using the Survivalink AED do not operate wireless radiotelephones within 1 meter of the Survivalink AED turn power OFF to the radiotelephone and other like equipment near the incident 300282 002 Rev EO 2002 Cardiac Science Inc Page 9 Section 1 Safety ee lee Et pr CAUTION Moving the Patient During a Rescue During a rescue attempt excessive jostling or moving of the patient may cause AEDs to improperly analyze the patient s cardiac rhythm Stop all motion or vibration before attemptin
47. is reached Non Shockable Rhythm or Patient Converts to NSR If the patient has a non shockable rhythm or at some point during the rescue sequence converts to a non shockable rhythm the voice prompt will say Check pulse If no pulse give CPR If the patient is not breathing continue CPR If the patient has a pulse is conscious and breathing normally make the patient as comfortable as possible and wait for Advanced Life Support ALS to arrive Continue to follow the voice prompts until the ALS personnel arrive or proceed as recommended by the Medical Director Page 46 2002 Cardiac Science Inc 300282 002 Rev EO Section 4 Rescue Transfer Patient to ALS Personnel 1 With the electrodes still attached to the patient disconnect the electrodes from the Survivalink AED 2 Close the lid of the Survivalink AED 3 Allow the ALS personnel to transport the patient to the hospital or proceed as recommended by the Medical Director 300282 002 Rev EO 2002 Cardiac Science Inc Page 47 Section 4 Rescue Post Rescue Process After transferring the patient to ALS personnel do the following to prepare the Survivalink AED for the next rescue 1 Connect a new pair of electrodes to the Survivalink AED 2 Check the expiration date on the electrode package for expiration 3 Place one electrode expiration date sticker on the outside of Survivalink AED where it can be viewed without opening the
48. k AED Indicators The following indicators are located on the Survivalink AED Status Indicator The status indicator is located on the Survivalink AED handle When this indicator turns GREEN the Survivalink AED is RescueReady This C means the Survivalink AED self tests have verified the following Battery has an adequate charge Electrodes are properly connected Integrity of the internal circuitry is good When the Status indicator is RED maintenance is required Nf Audible Maintenance Indicator When the daily or monthly self tests determine maintenance is required an audible warble beep is sounded every 30 seconds until the lid is opened the battery is removed or the battery power is depleted For maintenance not requiring qualified service personnel closing the lid will deactivate the audible warble beep until the next self test determines the need for maintenance Refer to the Maintenance amp Troubleshooting section when maintenance is required Diagnostic Panel The diagnostic panel is under the lid of the Survivalink AED and contains various indicators and a button A SmartGauge Battery Status Indicator B Electrodes Indicator RESCUE QD RESUME Page 34 2002 Cardiac Science Inc 300282 002 Rev EO Section 3 Setup SmartGauge Battery Status Indicator The SmartGauge Battery Status indicator has five 5 LEDs four 4 GREEN and one 1 RED The top four GREEN LEDs di
49. lator proof type BF patient connection internally powered only continuous operation IP23 amp not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide The device output has been tested and found to withstand the effects of another defibrillator without damage CE CE Marked by TUV Product Services 0123 per the Medical Device Directive 93 42 EEC of the European Nations UL and cUL Classified by Underwriters Laboratories Inc with respect to electric shock fire and mechanical hazards only in accordance with UL 2601 1 and IEC 601 2 4 IEC SC 62D WG2 O Dowd and CAN CSA C22 2 No 601 1 M90 and 45JF Electrical Construction Safety and Performance IEC 601 1 1988 Amendments 1 1991 amp 2 1995 IEC 601 2 4 2nd Edition IEC SC 62D WG2 O Dowd 97 08 ANSI AAMI DF 39 1993 Electromagnetic Compatibility EMC IEC 601 1 2 1993 ANSI A AMI DF 39 1993 Section 3 3 21 Page 72 2002 Cardiac Science Inc 300282 002 Rev EO Section 7 Technical Data Emissions Field Models Standard or Compliance E M 9100 9110 EN 55011 C I S P R 11 Group 1 Category B 9200 9210 RTCA DO 160D Section 21 Category L Category B during charging RTCA DO 199 Section 6 2 2 Magnetic 9100 9110 AAMI DF39 0 5mT on surface except for 9200 9210 within 5cm of the lid magnet and the speaker RTCA DO 160D Section 15 Category Z 9
50. link AED performs its daily self tests After the Survivalink AED completes the tests you will hear the voice prompt Place Electrodes The status indicator on the Survivalink AED handle will switch to GREEN 2 Close the lid the Survivalink AED is RescueReady 300282 002 Rev EO 2002 Cardiac Science Inc Page 31 Section 3 Setup What You Should Know About the Electrodes The electrodes come in a ready to use sealed package containing one pair of self adhesive electrodes with an attached cable and connector The electrodes are disposable and should be thrown away after one rescue The electrodes have a limited shelf life and should not be used beyond the expiration date Keep a fresh pair of electrodes plugged into the Survivalink AED at all times Refer to the operating instructions on the electrode package for operation temperatures Note Storing the Survivalink AED with the electrodes installed at extreme temperatures may decrease electrode shelf life An audible alert will be heard after the daily self test if the electrodes are missing damaged or unplugged The audible alert will not be heard if the Electrode Test selectable option is disabled using MDLink CAUTION Use Only Cardiac Science Approved Equipment Using batteries electrodes cables or optional equipment other than those approved by Cardiac Science may cause the Survivalink AED to function improperly during a rescue CAUTION Pos
51. mits 300282 002 Rev EO 2002 Cardiac Science Inc Page 15 Section 1 Safety Serial Number SN Lot Lot Number Additional information is provided in the Survivalink AED Operation and 1 Service Manual gt Points to important information regarding the use of the Survivalink AED Lift Here Page 16 2002 Cardiac Science Inc 300282 002 Rev EO Introduction Overview This section presents information about the Survivalink AED its use and the training requirements for operation Topic Page Survivalink AED 18 Survivalink AED Parts and Features 20 Survivalink AED Operators and Indications for Use 22 Survivalink AED Operator Training Requirements 23 300282 002 Rev EO 2002 Cardiac Science Inc Page 17 Section 2 Introduction Survivalink AED Survivalink AED Description The Survivalink AED is a self testing battery operated automated external defibrillator AED After applying the Survivalink AED s electrodes to the patient s chest the Survivalink AED automatically analyzes the patient s Electrocardiogram ECG The Survivalink AED advises you to deliver a defibrillation shock upon analyzing one of the following shockable cardiac rhythms Ventricular fibrillation when peak to peak amplitude is greater than asystole threshold 0 15 mV nominal and the cardiac rhythm rate is at least 180 bpm Beats Per Minute Ventricular tachyc
52. move the electrodes place them on the patient and press the Rescue Resume button to continue the rescue Ifthe electrodes are soiled expired or damaged replace the electrodes with a new pair place them on the patient and press the Rescue Resume button to continue the rescue e Ifa rescue is not in progress plug in a pair of room temperature packaged electrodes and the voice prompt should stop Page 64 2002 Cardiac Science Inc 300282 002 Rev EO Section 6 Maintenance amp Troubleshooting Battery Questions and Answers The following table answers frequently asked questions about the battery Questions and Answers gt When is the battery considered low The battery is considered low when the Replace indicator is lit and there are approximately 9 more defibrillation shocks remaining If I have a spare battery for my Survivalink AED should 1 rotate the batteries No Replace the battery when the Replace indicator is lit Is there a volume adjustment for the voice prompt No The volume level is preset at the factory 20 DI O O gt What can I do to keep the Survivalink AED warm when a rescue is in an isolated area and at subzero temperatures When travel to a rescue involves exposing the Survivalink AED to extremely cold temperatures for an extended period of time as with a snowmobile keep the elec trodes and the battery warm by removing
53. n you do the following Open the lid of the Survivalink AED and Apply the electrodes to the patient s chest After recording the rescue data it can be retrieved stored and printed using a personal computer and RescueLink See the RescueLink Manual for details Inserting a Rescue Data Card Into the Survivalink AED Insert a blank Rescue Data Card into Survivalink AED s card slot before beginning a rescue Do this as part of the initial Survivalink AED setup Data Access Door procedure and after each rescue To insert the Rescue Data Card 1 Open the data access door 2 Insert the Rescue Data Card arrows side up by sliding it into the card slot with the arrows pointing toward the Survivalink AED Card Slot dl 3 After firmly seating the Rescue Data Card close the data access door Storing Data on a Rescue Data Card Rescue Data storage conditions RESUME When you insert a blank Rescue Data Card before placing the electrodes on the patient the rescue data will record on the card If you place the electrodes on a patient with a full Rescue Data Card in the slot the voice prompt will say Card full Storing internally and the rescue data will be stored in internal memory of Survivalink AED When the internal memory and the Rescue Data Card are both full the voice prompt will say Data in memory Do not push Resume button until data is downloaded unless you must do a rescue
54. nce Inc Page 29 Section 3 Setup pg gt Battery Life The expected life of a Cardiac Science battery is defined as the number of vears the battery can be expected to last when installed in the Survivalink AED The following table represents the expected life of the Survivalink AED when used in Standby Mode Model Expected Operating Life 9141 Extended Life Lithium 5 years The expected life will decrease as the Survivalink AED is used in Operating Mode Store the Survivalink AED with the battery installed at temperatures between 0 C to 50 C 32 F to 122 F and relative humidity between 5 to 95 non condensing Note Storing the Survivalink AED with the battery installed at extreme temperatures may decrease battery life Battery Shelf Life All Cardiac Science batteries have a shelf life of five years Shelf life is defined as the length of time a battery can be stored prior to installation into the Survivalink AED without degrading its performance Store batteries not installed in the Survivalink AED at temperatures between 0 C to 50 C 32 F to 122 F and relative humidity between 5 to 95 non condensing WARNING Battery is Not Rechargeable Do not attempt to recharge the battery Any attempt to recharge the battery may result in an explosion or fire hazard CAUTION Battery Disposal Recycle or dispose of the lithium battery in accordance with all federal state and local la
55. nk AED RescueReady diagnostics are functioning properly and to verify the integrity of the case Verifying the Integrity of the Electrodes and Circuitry To verify the integrity of the electrodes and circuitry do the following 1 Open the Survivalink AED lid 2 Remove the electrodes 3 Close the lid 4 Confirm that the Status indicator turns RED You must enable the Electrode self test for this test Refer to the MDLink manual 5 Open the lid and confirm that the Electrode indicator is lit 6 Reconnect the electrodes and close the lid 7 Verify that the Status indicator turns to GREEN 8 Open the lid and confirm that no diagnostic indicators are lit 9 Check the expiration date for the electrodes if expired replace them 10 Check the electrode s packaging integrity 11 Close the lid Page 56 2002 Cardiac Science Inc 300282 002 Rev EO Section 6 Maintenance amp Troubleshooting Verifying the Integrity of the Service Indicator LED and Cir cuitry To verify the integrity of the service indicator LED and circuitry do the following 1 Immediately after opening the Survivalink AED lid press and hold the Rescue Resume button and confirm that the Service LED is lit Release the Rescue Resume button Close the lid Verify that the Status indicator returns to GREEN Open the lid and confirm that no diagnostic indicators are lit Close the lid
56. no pulse give CPR Perform CPR if there is no pulse 300282 002 Rev EO 2002 Cardiac Science Inc Page 45 Section 4 Rescue Note During a rescue the text display provides the rescuer with the voice prompts in written form elapsed time of rescue and number of shocks delivered For a complete description of displayed text see Voice Prompt and Text Display Descriptions on page 36 CPR Mode After the third defibrillation shock is delivered the voice prompt will say Check pulse Ifno pulse give CPR Note During CPR AED s equipped with the optional text display will show a countdown CPR timer 13 Perform CPR if the patient has no pulse Note Ifthe Continue CPR prompt or two toned beep option has been enabled using MDLink you will hear a Continue CPR voice prompt or a beep every 15 seconds during the CPR session See the MDLink Manual Repeat Analyze Charge Defibrillation Shock Sequence After CPR the voice prompt will say Do not touch patient Analyzing rhythm The Survivalink AED will again analyze the patient s cardiac rhythm upon detecting a shockable rhythm the three shock sequence will repeat The analyze charge defibrillation shock sequence of three defibrillation shocks followed by CPR will repeat until one of the following occurs A non shockable rhythm is detected Electrodes are disconnected The maximum number of defibrillation shocks per rescue
57. o cause this prompt 300282 002 Rev EO 2002 Cardiac Science Inc Page 63 Section 6 Maintenance amp Troubleshooting Diagnostics Questions and Answers continued Questions and Answers 14 The Survivalink AED did not sound an audible alert when I removed the electrodes and closed the lid Why Missing electrodes or a low battery will only trigger the audible maintenance indi cator after the Daily self test The lid closed self test only activates the Status indicator providing the rescuer with time to replace the electrodes after a rescue without triggering the audible alert 15 O How many defibrillation shocks can I deliver when the Replace indicator is lit Survivalink AED can deliver approximately 9 defibrillation shocks from the time the indicator is initially lit However you should replace the battery as soon as pos sible If you must replace the battery during a rescue you have one minute to replace the battery or a new rescue will begin 16 Why do I get the voice prompt Press flashing button to continue rescue when I open the lid How do I get the message to stop Several conditions may initiate this prompt including cold soiled or expired elec trodes Ifthe prompt occurs while the electrodes are on the patient push the Rescue Resume button and continue with the rescue Ifthe prompt occurs and the electrodes are in the package re
58. o obtain warranty service for your product call us toll free at 800 991 5465 or 952 939 4181 seven days a week 24 hours a day Our technical service representative will try to resolve your issue over the phone If necessary and in our sole discretion we will arrange for service or a replacement of our product What We Will Do If your Cardiac Science product contains defects in material or workmanship and is returned within 30 days of the date it was purchased at the direction of a technical service representative we will replace it with a new product of equal value at no charge to you provided the warranty applies If your Cardiac Science product contains defects in material or workmanship and is returned at the direction of a technical service representative after 30 days but within the warranty period Cardiac Science at its sole discretion will repair your product or replace it with a new or reconditioned product of the same or similar design The repaired or replacement product will be warranted subject to the terms and conditions of this Limited Warranty for either a 90 days or b the remainder of the original warranty period whichever is longer provided the warranty applies and the warranty period has not expired Obligations and Warranty Limits Limited Warranty Obligation Exclusive Remedy THE FOREGOING LIMITED WARRANTY IS IN LIEU OF AND SPECIFICALLY EXCLUDES AND REPLACES ALL OTHER EXPRESS OR IMPLIED WARRANTIES
59. ode application No Special preparation is not usually necessary However the chest should be as clean dry and as oil free as practical How do I know when the electrodes are safe to touch The only time energy can be delivered to the electrodes is when the Rescue indica tor is flashing and the Survivalink AED is sounding the charged tone The elec trodes are safe to touch at all other times However touching the electrodes during analysis mode may interfere with rhythm analysis Page 60 2002 Cardiac Science Inc 300282 002 Rev EO Section 6 Maintenance amp Troubleshooting Rescue Questions and Answers continued Questions and Answers 7 Q What happens if the battery is low when I begin a rescue A When the Replace indicator is initially lit when the lid is first opened or at any time during a rescue the Survivalink AED issues the Battery Low prompt once however the Survivalink AED is still capable of delivering approximately 9 more defibrillation shocks When the Survivalink AED is not capable of delivering any more shocks it contin uously repeats the Battery low prompt To continue the rescue attempt leave the lid open and replace the battery You must install the replacement battery within 60 seconds to continue the current rescue When battery replacement takes longer than 60 seconds or the lid is closed the rescue sequence starts over 8 Q How do I set
60. pening failure to follow instructions improper use abuse neglect fire flood war or acts of God Cardiac Science does not warrant your Cardiac Science product to be compatible with any particular other medical device This Limited Warranty is Void if Any Cardiac Science product is serviced or repaired by any person or entity other than Cardiac Science unless specifically authorized by Cardiac Science Any Cardiac Science product case is opened by unauthorized personnel or if a product is used for an unauthorized purpose Any Cardiac Science product is used in conjunction with incompatible parts or accessories including but not limited to batteries Parts and accessories are not compatible if they are not Cardiac Science products or the functional equivalent If The Warranty Period has Expired If your Cardiac Science product is not covered by our Limited Warranty call us toll free at 800 991 5465 or 952 939 4181 for advice as to whether we can repair your Cardiac Science product and for other repair information including charges Charges for non warranty repairs will be assessed and are your responsibility Upon completion of the repair the terms and conditions of this Limited Warranty shall apply to such repair or replacement product for a period of 90 days This warranty gives you specific legal rights and you may also have other rights which vary from state to state 400474 002 Rev CO 5420 Feltl Road
61. rage of new rescue data in the Survivalink AED 300282 002 Rev EO 2002 Cardiac Science Inc Page 13 Section 1 Safety Unconscious th A RED with a BLACK X means the Survivalink AED requires operator attention or maintenance and is not RescueReady For purposes of retaining simple clear instructions this symbol will be referred to as RED in the remainder of this manual GREEN without a BLACK X means the Survivalink AED is RescueReady For purposes of retaining simple clear instructions this symbol will be referred to as GREEN in the remainder of this manual Use by or install by date Expiration Date Replace by this date Latex Free Disposable Single patient use only Tear here to open Do not recharge battery The patient is unconscious Page 14 2002 Cardiac Science Inc 300282 002 Rev EO Section 1 Safety Not Breathing The patient is not breathing M No Pulse The patient has no pulse Place the electrodes on the chest of the patient The maximum energy delivered m max For use by or on the order of a Physician or persons licensed by state law Dispose of properly in accordance with all state province and country regulations Do not incinerate or expose to open flame Explosion Hazard Do not use in the presence of a flammable gas including concentrated oxygen Upper and lower temperature li
62. re not properly connected to the Survivalink AED ECG analysis and defibrillation shock delivery are therefore inhibited The voice prompt will say Check Electrodes when electrode contact is inadequate Automated Interpretation of the ECG The Survivalink AED Rhythm Recognition Detection System is designed to recommend a defibrillation shock when placed on a patient who is unconscious not breathing and has no pulse when it detects Ventricular fibrillation when peak to peak amplitude is greater than asystole threshold 0 15 mV nominal and cardiac rhythm rate of at least 180 bpm Ventricular tachycardia cardiac rhythm rate is at least 180 bpm Supraventricular tachycardia cardiac rhythm rate is at least 180 bpm The Survivalink AED Recognition Detection System will not recommend a defibrillation shock for all other ECG rhythms that do not meet these criteria including Asystole and normal sinus rhythms ECG analysis is performed on a 9 second sample of ECG Operator Control of Defibrillation Shock Delivery The Survivalink AED Recognition Detection System causes the Survivalink AED to automatically charge when the Survivalink AED detects a shockable cardiac rhythm Audio and visual prompts are used to 2 Defibrillation In Cummins R ed Advanced Cardiac Life Support American Heart Association 1997 4 9 300282 002 Rev EO 2002 Cardiac Science Inc Page 79 Section 7 Technical Data advise you that
63. rieving Rescue Data eee 51 Inserting a Rescue Data Card Into the Survivalink AED 51 Storing Data on a Rescue Data Card 91 Transferring Data to a Rescue Data Card 92 Page 4 2002 Cardiac Science Inc 300282 002 Rev EO Table of Contents Retrieving Data From a Rescue Data Card 52 Section 6 Maintenance 8 Troubleshooting 53 SelfsTests souls ai ee baled oy wa omic reme Late WE ada 54 Daily Self Test 00 0 ee eee ee 55 Weekly Self Test 0 0 ee ee 55 Monthly Self Tests 55 Maintenance 2 20 eee 56 Daily sang i pb eqs 56 Performing the Annual Maintenance 56 Repair Service and Service Indications 58 Authorized Repair Service u 58 Service Indications 0c eee eee 58 Indicator Troubleshooting Table 0 0 00 cee eee 59 Rescue Questions and Answers el essen 60 Diagnostics Questions and Answers 00 a 62 Battery Questions and Answers 02 eee 65 Section 7 Technical Data 67 Parameters 0c eee eee 68 Safety and Performance Standards 00 eee u 72 Survivalink AED Models 9100 9110 amp 9200 9210 72 Clinical Study Summary isses 81 Comparison of Survivalink s Biphasic and Monophasic Truncated Exponential Waveforms
64. rompt Optional Text Display 9200 9210 Models only When You Will Hear the Prompt Check pulse If no pulse give CPR CHECK PULSE IF NO PULSE GIVE CPR One of the following e After the Survivalink AED delivers 3 consecutive defibrillation shocks and suspends analyzing for one minute After the Survivalink AED detects a non shockable cardiac rhythm during cardiac rhythm analysis When the Survivalink AED detects a shockable cardiac rhythm but the Rescue button is not pushed for approximately 2 1 2 minutes from the placement of electrodes on the patient or performing CPR Check electrodes CHECK ELECTRODES During the rescue if the electrodes become detached from the patient or the Survivalink AED so the Surviv alink AED cannot detect the cardiac rhythm The rescue will continue after you correct the electrode placement problem Battery low BATTERY LOW Occurs once when the battery voltage becomes low although a rescue can continue for approximately 9 more shocks When the battery is too low to do a rescue the phrase repeats continu ously and you must replace the battery before continuing with the rescue If completely depleted all Survivalink AED activity will terminate 300282 002 Rev EO 2002 Cardiac Science Inc Page 39 Section 4 Rescue Optional Text Display Voice Prompt 9200 9210 Models only When You Will Hear the Prompt Data
65. rvivalink AED Models equipped with the text display the text displayed mimics most of the audible voice prompts Also displayed is system initialization rescue and diagnostics information In some cases the text displayed is an abbreviated version of the actual voice prompts The following table lists the voice and text prompts and their respective meanings Optional Text Display Voice Prompt 9200 9210 Models only When You Will Hear the Prompt Place electrodes PLACE ELECTRODES When you open the lid of the Surviv alink AED the phrase repeats every 5 seconds until you place the electrodes on the patient or you close the lid Do not touch DO NOT TOUCH PATIENT Repeatedly while the Survivalink AED patient Analyz ANALYZING RHYTHM analyzes the cardiac rhythm of the ing rhythm patient after the electrodes have been placed and again after CPR has been performed Charging CHARGING When the Survivalink AED is prepar ing to deliver a defibrillation shock Stand clear Push STAND CLEAR After the Survivalink AED is fully flashing button to PUSH BUTTON TO SHOCK charged and ready to deliver the rescue defibrillator shock Stand Clear means that no one should be touching the patient The RED Rescue indica tor flashes and the phrase repeats for 30 seconds or until you push the Rescue button Page 38 2002 Cardiac Science Inc 300282 002 Rev EO Section 4 Rescue Voice P
66. sible Improper AED Performance Using electrodes that are damaged or expired may result in improper AED performance Examine the electrodes before use The electrode package seal should be intact and the electrode expiration date should not be expired Do not open or remove the outer wrapper of the electrode package until performing a rescue If the wrapper is opened or damaged do not use the electrodes To Install the Electrodes 1 Remove one of the expiration date stickers from the surface of the electrode package and apply it to the outside of the Survivalink AED The expiration date of the electrodes will then be readable without opening the lid of the Survivalink AED 2 Open the lid of the Survivalink AED Page 32 2002 Cardiac Science Inc 300282 002 Rev EO Section 3 Setup Match the color code of the connectors red to red then slide the electrode connector along the recess in the Survivalink AED case as shown in the drawing until the electrode connector fully mates to the connector of the Survivalink AED Slide the electrode package fully into the Survivalink AED electrode compartment inserting the cable end first as shown in the drawing Loop the excess cable length as shown in the drawing With the electrode package completely under the Survivalink AED lid as shown in the drawing close the lid 300282 002 Rev EO 2002 Cardiac Science Inc Page 33 Section 3 Setup Survivalin
67. source is available If you attempt a second rescue without retrieving or erasing the rescue data in internal memory upon opening the lid the voice prompt will say Data in memory Do not push Resume button until the data is downloaded unless you must do a rescue Survivalink AEDs equipped with an optional text display will display the following DATA IN MEMORY and PUSH BUTTON TO CLEAR Pressing the Resume button will erase the data and allow the rescue attempt to proceed Note Do not press the Resume button unless you are sure you want to erase the internal memory in the Survivalink AED External Memory Storage Survivalink AED models 9110 9210 come equipped with a Rescue Data Card slot Rescue data can be stored on a removable Rescue Data Card Upon completing the rescue the card can be removed for data retrieval ZA without taking the Survivalink AED out of use The Rescue Data Card stores ECG and other event data Using MDLink and a Rescue Data Card the Survivalink AED can record ECG event data along with the ambient sound at the rescue site The Rescue Data Card has 8 megabytes MB of storage memory The 8 MB card is capable of recording up to ten hours of ECG and event data or up to 40 minutes of voice ECG and event recording Q Page 50 2002 Cardiac Science Inc 300282 002 Rev EO Section 5 Data Management Storing and Retrieving Rescue Data Rescue data recording begins whe
68. splay the remaining capacity of the battery much like a fuel gauge With use the GREEN LEDs gradually go out from top to bottom as battery capacity decreases When the green LEDs go completely out and the bottom RED LED lights replace the battery When the bottom Red LED initially lights upon opening the lid or at any time during a rescue you will hear the Battery Low prompt once However the Survivalink AED should still be capable of delivering approximately 9 more defibrillation shocks When the Survivalink AED battery cannot deliver any more shocks it continuously repeats the Battery low prompt To continue the rescue leave the lid Open and replace the battery You have 60 seconds to install the battery If 60 seconds expire or the lid is closed for more than 15 seconds during battery installation the rescue sequence starts over If the battery is completely depleted of power all Survivalink AED electrical activity will terminate Lr Lal Electrodes Indicator The Electrodes LED lights up when the electrodes are Disconnected from the patient Not properly connected to the Survivalink AED Not within specifications cold dirty damaged EHI gt Service Indicator The Service LED lights up when the Survivalink AED requires maintenance that can only be performed by qualified service personnel Rescue Resume Button The Survivalink AED has one button called the Rescue Resume button it is
69. t American Heart Association 1997 4 9 Page 18 2002 Cardiac Science Inc 300282 002 Rev EO Section 2 Introduction The European CPR Guidelines or Universal ALS European Protocol recommends up to 3 minutes of CPR if the first analysis decision is non shockable or following two consecutive non shockable analysis decisions The three 3 defibrillation shocks are delivered in a pre programmed sequence of escalating monophasic or biphasic energies The Survivalink AED Models 9100 9110 first defibrillation shock is set at 200J The second defibrillation shock is programmable for either 200J or 300J The third defibrillation shock and all subsequent shocks are set at the maximum energy which is 360J The Survivalink AED Models 9200 9210 first defibrillation shock is set at a low current setting The second defibrillation shock is programmable for either low current or high current The third defibrillation shock and all subsequent shocks are set at the high current setting 3 FirstSave Models 9200 9210 The low current and high current shocks are variable energy The actual energy is determined by the patient s impedance 300282 002 Rev EO 2002 Cardiac Science Inc Page 19 Section 2 Introduction Survivalink AED Parts and Features IntelliSense Battery The IntelliSense battery is a non rechargeable battery incorporating an integrated memory chip that maintains the complete battery history
70. tely one year 12 Q When I open the lid why do I get the voice prompt Data in memory Do not push Resume button until data is downloaded unless you must do a rescue How do I get the message to stop occurring Page 62 2002 Cardiac Science Inc 300282 002 Rev EO Section 6 Maintenance amp Troubleshooting Questions and Answers A This message occurs when there is a previously stored rescue in the internal mem ory of the Survivalink AED AND The Rescue Data Card memory is full or The Rescue Data Card is not inserted You can clear the message by 1 Inserting a blank Rescue Data Card and transferring the rescue data from the internal memory of the Survivalink AED to the Rescue data card and erasing the stored rescue data do this if the message does not occur during a rescue attempt 2 Downloading the rescue data with RescueLink and erasing the stored rescue data 3 Pressing the Rescue Resume button to erase the internally stored rescue data 4 Replacing a full Rescue Data Card with an empty one do this when the message occurs during a rescue attempt 13 O When I open the lid why do I get the voice prompt Card full Storing internally A There is a previous rescue in the optional Rescue Data Card and the rescue data from the current rescue will be stored in the internal memory of the Survivalink AED An invalid card other than the Rescue Data Card can als
71. the Survivalink AED internal clock A Set the clock by using the RescueLink Software Program and a PC 9 Q What happens if I close the lid in the middle of a rescue attempt A Ifyou close the lid during a rescue you must re open the lid within 15 seconds to continue the rescue If the lid remains closed for more than 15 seconds a new res cue will initiate when the lid is re opened Note Ifthe lid is closed during a rescue while the electrodes are connected to the patient the status indicator may turn RED When the lid is re opened however the rescue may be continued even though the status indicator remains RED 300282 002 Rev EO 2002 Cardiac Science Inc Page 61 Section 6 Maintenance amp Troubleshooting Diagnostics Questions and Answers The following table answers frequently asked questions about Diagnostics Questions and Answers 10 Q My Survivalink AED is sounding an audible alert Why How do I stop it A The audible alert indicates that the self test detected a need for maintenance or cor rective action Determine the maintenance required by using the Troubleshooting Table in this chapter Opening and closing the lid may turn OFF the audible alert until the next self test The Status indicator however will remain RED 11 Q How long will the audible alert sound before the battery is worn down A A full Extended Life battery can continue an audible alert for approxima
72. the optional text display the top line of the display will show the Control Code Version Prompt Set Identifier and the Text Set Identifier The bottom line will display the date and time information When performing the self tests the Survivalink AED completes the following steps automatically Turns itself ON Performs the associated self test Turns itself OFF When a self test detects an error a visual and or audible alert becomes active By monitoring these visual and audible alerts you can ensure the Survivalink AED has performed its diagnostics and is ready or unable to conduct a rescue For the appropriate response to specific alerts refer to the Troubleshooting Table in this chapter When the Survivalink AED is in use during any scheduled self test time period that self test sequence is postponed 24 hours If you open the Survivalink AED lid while the Daily self tests are in progress the tests stop and the Survivalink AED begins a normal rescue sequence During self tests the status indicator will turn RED Upon successful completion of self tests the indicator will turn back to GREEN There will be no other indication of a self test in progress The self tests do not eliminate the need for scheduled maintenance CAUTION Temperature Humidity Pressure Extremes Exposing the Survivalink AED with the battery installed to extremes outside the following operation and standby conditions will cause the self tests to b
73. urs when the lid is first opened The text display shows the user the identifiers for the internal code voice prompts and text prompts versions The text display also shows the current date and time During a rescue the text display shows the number of shocks delivered and the elapsed time from the beginning of the rescue when the lid was first opened The text version of the voice prompts will also be displayed The text display will also display information useful in assessing the status of the AED and other informational messages Each voice prompt or message may be associated with one or two lines of text If two lines of text are used the text will alternate every 1 1 2 seconds Note There is a 3 second delay between the time the AED lid is opened and the start of the rescue This 3 seconds is not included in the elapsed rescue time Page 36 2002 Cardiac Science Inc 300282 002 Rev EO Section 4Rescue Overview This section presents information about how to use the Survivalink AED to perform a rescue Topic Page Voice Prompt and Text Display Descriptions 38 Pre Rescue Safety Information 42 Performing the Rescue 43 Post Rescue Process 48 300282 002 Rev EO 2002 Cardiac Science Inc Page 37 Section 4 Rescue Voice Prompt and Text Display Descriptions The voice prompts are announced when you open the Survivalink AED lid and at appropriate times during a rescue On Su
74. used for all operations This button is located on the diagnostic panel and serves two functions Delivers a defibrillation shock Rescue Clears the internal memory of previous rescue data so that new rescue data can be stored Resume 300282 002 Rev EO 2002 Cardiac Science Inc Page 35 Section 3 Setup Rescue Button Indicator LEDs RESUME Resume Button Indicator LEDs Text Identifier Voice Identifier Internal Code Identifier XX XX XXKX XXXX Mmm DD YYYY XX Current M Current Time Elapsed Rescue Time Number of Shocks Delivered SHOCKS X XXX ANALYZING RHYTHM Voice Prompt or Message Rescue Indicator The word Rescue and the rescue button indicator LEDs will illuminate RED when the Survivalink AED is ready to deliver a defibrillation shock to the patient Resume Indicator The word Resume will illuminate YELLOW and the resume button indicator LEDs will illuminate RED when one of the following conditions occurs nternal and external memory are already full at the start of a rescue Electrodes are placed on the patient before opening the lid Text Display Optional The text display is a backlit Liquid Crystal Display LCD with 2 lines of text each having 20 characters The text display provides the rescuer with information regarding system initialization text prompts and data during a rescue and diagnostics System initialization occ
75. ws To avoid fire and explosion hazards do not burn or incinerate the battery CAUTION Possible Improper Device Performance Use of any batteries other than those approved by Cardiac Science may cause the Survivalink AED to function improperly during a rescue The use of other brands of batteries other than those approved by Cardiac Science may void the Cardiac Science Limited Warranty Page 30 2002 Cardiac Science Inc 300282 002 Rev EO Section 3 Setup If a depleted battery is not able to be disposed of properly label the battery in some manner to prevent it from being reused To Install the Battery 1 With the label on the battery facing the Survivalink AED battery compartment insert the battery as shown in the drawing 2 Push the latched end of the battery firmly into the Survivalink AED as shown in the drawing until the battery snaps into place you will hear a loud click The exposed side of the battery should be flush with the outside of the Survivalink AED case If the battery is not properly installed the Survivalink AED will not operate Activating the Survivalink AED Self Tests The Status indicator on the Survivalink AED handle will only turn GREEN RescueReady after the self test is complete To activate a self test 1 Open the lid of the Survivalink AED and the following should occur The indicator lights on the diagnostic panel will toggle sequentially On Off while the Surviva

Download Pdf Manuals

Related Search

Related Contents

Bartscher Sushi Bar 5x 1/2 GN 110.135G  12” NON-STICK ELECTRIC SKILLET SARTéN ELéCTRICA  Asset Servicing Client User Manual  Chief Manufacturing XSM Series User's Manual  Kit Veicular Nokia CK-100 Manual do Usuário e de  Model 42i - User Manual  Manual do Usuário Nokia 225 Dual SIM  Exovest User Manual  NORMAND LÉVESQUE  Propane/LP Patio Heater Owner`s Manual IMPORTANT  

Copyright © All rights reserved. Failed to retrieve file