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Section 7: Technical Data

Page 72

300282-002 Rev. E0

Safety and Performance Standards

Survivalink AED Models 9100/9110 & 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, defibrillator-proof type BF patient connection, internally

powered only, continuous operation, IP23 & 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 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) & 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/AAMI DF-39(1993) Section 3.3.21

Содержание SURVIVALINK AED

Страница 1: ...O P E R A T I O N S E R V I C E M A N U A L 9100 9110 9200 9210 S U R V I V A L I N K AED automated external defibrillator...

Страница 2: ...ND REPLACES ALL OTHER EXPRESS OR IMPLIED WARRANTIES INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE Some states do not allow limitations on...

Страница 3: ...m which you purchased this product to arrange training If you experience difficulty arranging training please contact us Extended warranties are available Please contact your sales representative or d...

Страница 4: ...STAGE NECESSARY IF MAILED IN THE UNITED STATES BUSINESS REPLY MAIL FIRST CLASS MAIL PERMIT NO 2135 HOPKINS MN POSTAGE WILL BE PAID BY ADDRESSEE Cardiac Science Inc 5420 Feltl Road Minneapolis MN 55343...

Страница 5: ...anner 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 Serv...

Страница 6: ...ts 20 Maintenance Indicators 20 Rescue Data Management 20 Text Display Optional 20 Internal Clock 21 Survivalink AED Operators and Indications for Use 22 Who Can Use the Survivalink AED 22 What is the...

Страница 7: ...mpt and Text Display Descriptions 38 Pre Rescue Safety Information 42 Performing the Rescue 43 Place Electrodes 43 Survivalink AED Analyzes Rhythm 44 Analyze Charge Defibrillation Shock 45 CPR Mode 46...

Страница 8: ...Questions and Answers 62 Battery Questions and Answers 65 Section 7 Technical Data 67 Parameters 68 Safety and Performance Standards 72 Survivalink AED Models 9100 9110 9200 9210 72 Clinical Study Su...

Страница 9: ...Table of Contents Page 6 2002 Cardiac Science Inc 300282 002Rev E0 Rescue Data Storage Card 85 MDLink Options Card 85 MDLink 85 MDLink Manual 85...

Страница 10: ...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...

Страница 11: ...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 DAN...

Страница 12: ...l 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 pati...

Страница 13: ...ay 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 1 Howeve...

Страница 14: ...e 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 temperat...

Страница 15: ...s regarding the safe and proper use of the Survivalink AED Defibrillator Proof Type BF Equipment The Survivalink AED when connected to the patient s chest by the electrodes can withstand the effects o...

Страница 16: ...dicates 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...

Страница 17: ...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...

Страница 18: ...maximum energy delivered 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...

Страница 19: ...diac Science Inc 300282 002 Rev E0 Serial Number Lot Number Additional information is provided in the Survivalink AED Operation and Service Manual Points to important information regarding the use of...

Страница 20: ...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 Oper...

Страница 21: ...ndicators Survivalink AED Rescue Sequence The Survivalink AED rescue sequence is consistent with the guidelines recommended by the American Heart Association AHA 2 and the European CPR Guidelines or U...

Страница 22: ...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 energ...

Страница 23: ...Battery 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...

Страница 24: ...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 cl...

Страница 25: ...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 p...

Страница 26: ...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 Addit...

Страница 27: ...Section 2 Introduction Page 24 2002 Cardiac Science Inc 300282 002 Rev E0...

Страница 28: ...Overview This section presents information on unpacking and setting up the Survivalink AED Topic Page Unpacking and Inspecting 26 Survivalink AED 27 What You Should Know About the Batteries 29 What Yo...

Страница 29: ...o 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 Ca...

Страница 30: ...k AED will operate within a specified condition This range varies depending on whether the device is in Operating Standby or Storage Mode A B C E D F G H I J K L F Speaker G Electrode connector H Diag...

Страница 31: ...to perform self tests or rescues Survivalink AED Operating and Standby Conditions CAUTION Temperature Humidity Pressure Extremes Exposing the Survivalink AED with the battery installed to extremes out...

Страница 32: ...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...

Страница 33: ...ngth 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 t...

Страница 34: ...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 th...

Страница 35: ...ill 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...

Страница 36: ...shown in the drawing until the electrode connector fully mates to the connector of the Survivalink AED 4 Slide the electrode package fully into the Survivalink AED electrode compartment inserting the...

Страница 37: ...s RED maintenance is required 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 o...

Страница 38: ...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 installatio...

Страница 39: ...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...

Страница 40: ...ection 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 Informatio...

Страница 41: ...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...

Страница 42: ...n 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...

Страница 43: ...the internal mem ory of the Survivalink AED Remove cable to continue rescue REMOVE CABLE When a serial communication cable is connected to the Survivalink AED dur ing a rescue the phrase repeats unti...

Страница 44: ...ator 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 usin...

Страница 45: ...telephone 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...

Страница 46: ...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 co...

Страница 47: ...he 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 disconnec...

Страница 48: ...ink 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 detec...

Страница 49: ...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...

Страница 50: ...ient 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 transpo...

Страница 51: ...s 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...

Страница 52: ...gement 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 Ex...

Страница 53: ...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...

Страница 54: ...escue Data Card arrows side up by sliding it into the card slot with the arrows pointing toward the Survivalink AED 3 After firmly seating the Rescue Data Card close the data access door Storing Data...

Страница 55: ...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...

Страница 56: ...s 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 Troublesh...

Страница 57: ...y 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...

Страница 58: ...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...

Страница 59: ...tics 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...

Страница 60: ...he 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 888 466 868...

Страница 61: ...6 8686 USA only 952 939 4181 USA and Canada 45 44 38 05 39 International Warning Shock hazard Do not disassemble the Survivalink AED Failure to observe this warning can result in personal injury or de...

Страница 62: ...ervice 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 RED Electrodes indicator LED is lit Connect...

Страница 63: ...alink AED prompt for CPR A The Survivalink AED will prompt for CPR After the Survivalink AED delivers 3 consecutive defibrillation shocks or After the Survivalink AED detects a non shockable cardiac r...

Страница 64: ...eplace 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 seque...

Страница 65: ...ctive 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 indica...

Страница 66: ...ta 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 inter...

Страница 67: ...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 Q Why do I get the voice prompt...

Страница 68: ...re battery for my Survivalink AED should I rotate the batteries A No Replace the battery when the Replace indicator is lit 19 Q Is there a volume adjustment for the voice prompt A No The volume level...

Страница 69: ...Section 6 Maintenance Troubleshooting Page 66 2002 Cardiac Science Inc 300282 002 Rev E0...

Страница 70: ...2002 Cardiac Science Inc Page67 Section 7 Technical Data Overview This section presents technical data about the Survivalink AED Topic Page Parameters 68 Safety and Performance Standards 72 Clinical...

Страница 71: ...ard 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...

Страница 72: ...3 in Width 27 cm 10 6 in Depth 31 cm 12 4 in Model Weight with Batteries and Electrodes 9100 3 36 kg 7 4 lb 9110 3 41 kg 7 5 lb 9200 3 50 kg 7 7 lb 9210 3 55 kg 7 8 lb Atmosphere Condition Temperatur...

Страница 73: ...Survivalink AED to its maximum energy The Survivalink AED typically takes 11 seconds to charge to its maximum energy after 15 maximum energy charges A battery with reduced capacity that causes the Re...

Страница 74: ...inal Survivalink AED Self Test Sequence Frequency of Self Test What is Tested Daily Battery electrodes internal electronics rescue resume button and software Monthly every 28 days Battery under load e...

Страница 75: ...n 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...

Страница 76: ...n 6 2 2 Magnetic 9100 9110 9200 9210 AAMI DF39 0 5mT on surface except for within 5cm of the lid magnet and the speaker RTCA DO 160D Section 15 Category Z 9200 9210 RTCA DO 199 Section 6 2 1 during an...

Страница 77: ...mperature Variation 9200 9210 RTCA DO 160D Section 5 Category C Free Fall Drop 9100 9110 9200 9210 IEC 68 2 32 1975 1 meter Shock Bump 9100 9110 IEC 68 2 29 25g and 6000 bumps 9200 9210 IEC 68 2 29 40...

Страница 78: ...9100 9110 Waveform all values are typical 300 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 75 1900 6...

Страница 79: ...sic 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...

Страница 80: ...are typical Phase 1 Phase 2 Patient s Impedance Ohms Voltage Volts Duration ms Voltage Volts Duration ms Energy 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 15...

Страница 81: ...red 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 75 1930 5 8 1324 3 2 220 290...

Страница 82: ...llation 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 Recognitio...

Страница 83: ...rhythmia Analysis Algorithm Performance Incorporating New Waveforms and Enhancing Safety American Heart Association AHA AED Task Force and approved by the AHA Science Advisory and Coordinating Committ...

Страница 84: ...ch 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 Monop...

Страница 85: ...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 sta...

Страница 86: ...Overview This section presents standard and optional parts and software for the Survivalink AED To place an order call Cardiac Science customer service at 800 991 5465 or 952 939 4181 Fax 952 939 419...

Страница 87: ...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 cloc...

Страница 88: ...ther 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 Ca...

Страница 89: ...Section 8 Parts Software Page 86 2002 Cardiac Science Inc 300282 002 Rev E0...

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