Pediatric Reduced Energy Defibrillation
Contents
1. 01 international cardiacscience com United Kingdom The Manse 39 Northenden Road Sale Manchester M33 2DH United Kingdom 44 161 926 0000 uk cardiacscience com France Parc de la Duranne 565 Rue Ren Descartes F 13857 Aix en Provence Cedex 3 France 433 4 88 19 92 92 france cardiacscience com Central Europe D A CH Oskar Schindler Strasse 3 D 50769 K ln Germany e 449 2132 93 5750 centraleurope cardiacscience com China 6 F South Building 829 Yi Shan Road Shanghai 200233 China 86 21 6495 9121 china cardiacscience co C Cardiac Science the Shielded Heart logo FirstSave Powerheart MasterTrak MDLink STAR IntelliSense RescueReady 0086 RescueCoach RescueLink RHYTHM x and Survivalink are trademarks of Cardiac Science Corporation Copyright 2008 Cardiac Science Corporation All Rights Reserved S C e N C e MDSS GmbH Schiffgraben 41 D 30175 Hannover Germany M 112 2013 003 A HM AUY ONN UOUN N N T T TNT2. Pediatric Reduced Energy Defibrillation Electrodes Instructions for Use 112 2013 003 A Copyright 2008 Cardiac Science Corporation All rights reserved For use with the following Cardiac Science Automated External Defibrillators AEDs only Powerheart AED 9200 series Powerheart AED G3 9300 series and FirstSave AED 9300 series Caution Restricted sale Federal law restricts this device to sale by or on the order of a physician or other licensed practitioner CARDIAC AT THE HEART OF SAVING Science LiyES gt Indications for Use Indications for Use Cardiac Science Pediatric Reduced Energy Defibrillation Electrodes are intended for use with only the following Cardiac Science Automated External Defibrillators AEDs Powerheart AED 9200 series Powerheart AED G3 9300 series and FirstSave AED 9300 series These electrodes when used with the AED provide reduced defibrillation energy and are intended for use only on children or infants up to 8 years old or up to 55 lbs 25 kg If the child appears older or larger use Cardiac Science adult defibrillation electrodes Do not delay treatment to determine the child s exact age or weight The AED is intended for use by personnel who have been trained in its operation The user should be qualified by training in basic life support or other physician authorized emergency medical response The AED is indicated for emergency treatment of victims exhibiting symptoms of sudd
3. acscience com 112 2013 003 A 7 Pediatric Reduced Energy Defibrillation Electrodes Instructions for Use cr F 2 Iv y M Iv 2 v 3 1 4 A 112 2013 003 A Summary of RHYTHM x Clinical Results Summary of RHYTHMx Clinical Results The Powerheart AED employs the patented RHYTHMx analysis algorithm designed and developed by Cardiac Science The RHYTHMXx algorithm was first marketed in the Powerheart AECD for in hospital use and later adapted for use in the Powerheart AED No modifications have been made to the RHYTHM x algorithm for pediatric applications The RHYTHM x analysis algorithm has a proven history of successful clinical use on thousands of adult patients over the past several years In addition Cardiac Science has completed extensive database testing with che RHYTHM lt x algorithm that demonstrates an extremely high rate of sensitivity and specificity SVT Detection Feature A feature that makes the RHYTHMX algorithm uniquely suited for pediatric applications is its SVT detection and discrimination function It uses two distinct rates for determining when a rhythm is shockable For chaotic heart rhythms such as VF the default rate for deciding when the rhythm is shockable is 160 beats per minute BPM For organized rhythms such as SVT or Normal Sinus Rhythm NSR the default rate is 200 BPM This unique feature is particularly significant for children since a pediatric heart may be perfusing while able
4. clinical use on adults in three commercially marketed products Powerheart AED Powerheart AECD and the Powerheart CRM Cardiac Rhythm Module Previous studies demonstrated that pediatric patients can be effectively treated with standard adult defibrillation algorithms Cardiac Science demonstrated through performance testing that the pediatric attenuator does not affect the ECG signal and performance of the Powerheart AED to detect and analyze ECG waveforms The Powerheart AED with pediatric electrodes was found to detect rhythm changes from SV VF as effectively as without the pediatric electrodes Adult and pediatric database testing clearly demonstrate that the Powerheart AED can perform well above the American Heart Association s performance recommendations of 75 to 90 for sensitivity and 95 to 99 for specificity 112 2013 003 A 12 Cardiac Science Corporation 3303 Monte Villa Parkway Bothell WA 98021 USA e 425 402 2000 US toll free 800 426 0337 e Fax 425 402 2001 info cardiacscience com Orders and Customer Care US and International 425 402 2000 US toll free 800 426 0337 Fax 425 402 2001 carecardiacscience com Technical Support US Fax 425 402 2022 e technicalsupport cardiacscience com http websupport cardiacscience com webchat International internationalsupport cardiacscience com Cardiac Science International A S Kirke Vaerloesevej 14 DK 3500 Vaerloese Denmark 45 4438 0500 Fax 45 4438 05
5. en cardiac arrest who are unresponsive and not breathing Post resuscitation if the victim is breathing the AED should be left attached to allow for acquisition and detection of the ECG rhythm If a shockable ventricular tachyarrhythmia recurs the AED will charge automatically and advise the operator to deliver therapy Contraindications for Use Do not use with Cardiac Science 9100 series AEDs FirstSave 9200 AEDs or non Cardiac Science AEDs 112 2013 003 A 1 Pediatric Reduced Energy Defibrillation Electrodes Instructions for Use Warnings and Cautions gt PRP BP BP ER WARNING Improper function For use only with the following Cardiac Science AEDs Powerheart AED 9200 series Powerheart AED G3 9300 series and FirstSave AED 9300 series These pads will not function properly with any other AEDs or defibrillators WARNING Shock hazard During shock delivery an AED applies high voltage to the patient Do not touch the patient pads or any other equipment connected to the patient when defibrillating WARNING Improper connection DO NOT pre connect Pediatric electrodes to an AED while in standby mode Caution Electrode degradation DO NOT open the package until ready to use the pads Caution Equipment damage Remove the Cardiac Science pediatric electrode pads before using other manufacturers defibrillation equipment Caution Improper equipment performance Using pads that are damaged or expired may r
6. equired Consult the accompanying AN documents or AED Operation and Service Manual for additional information Lia Consult instructions for Use Operating Storage Conditions 110 F Store electrodes in a cool dry place 0 C to 43 C or 32 F to 110 F sor f Humidity 5 to 95 non condensing 0 C Shipping Temperature Range 30 C to 65 C 22 F to 149 F 112 2013 003 A 3 Pediatric Reduced Energy Defibrillation Electrodes Instructions for Use Instructions for Use AN WARNING AED not rescue ready If the rescuer performs the steps below in a different sequence than outlined the AED may give a check electrodes or check pads message Unlike Cardiac Science adult defibrillation electrodes the construction of our pediatric electrodes does not allow a Cardiac Science AED to check that there is an adequate connection and that the electrodes are ready to use prior to their being applied to the patient 1 Remove clothing from the patient s chest and make sure the patient s chest is clean and dry 2 Tear open the pediatric pads package and remove the pads 3 Carefully peel one pad away from the liner 4 Standard pads placement Figure 1 a Place one pad with the sticky side to the patient s bare skin on the upper right chest as shown in Figure 1 Press the pad firmly to the patient s skin Carefully peel the second pad away from the liner Place the second pad on the patient s lo
7. esult in improper AED performance Examine the pads before use the package should be sealed and the expiration date should not have passed Do not use pads if expired 112 2013 003 A Operating Storage Conditions The Cardiac Science Pediatric Electrode System is FDA cleared for use with the Powerheart AED 9200 series Powerheart AED G3 9300 series and FirstSave AED 9300 series to treat children less than 8 years of age or less than 55 lbs who suffer cardiac arrest FDA 510 k marketing clearance was received with the adult energy protocol set to the 200J Variable Energy VE protocol and by demonstrating the ability of Cardiac Science s Pediatric Electrode System to automatically and safely reduce or attenuate the energy level of defibrillation shock s for children to approximately 50J Your AED medical director may choose this energy protocol or any of the other energy protocols which can be programmed in the Powerheart AED by using the MDLink software and connecting your PC via the enclosed serial cable to the Powerheart AED 9200 series and Powerheart AED G3 9300 series FirstSave AED G3 is preset to 200J variable energy Please call customer service at 888 466 8686 if you need assistance The Cardiac Science Pediatric Defibrillation Electrodes are Disposable Q Single patient use only Do not reuse x Latex Free These symbols can be found on the packaging or on the electrodes Attention r
8. he University of Michigan database containing actual pediatric patient data The analysis tested 384 episodes of non shockable rhythms and 1 episode of shockable rhythm in pediatric patients results of this analysis showed the Powerheart AED performed with 100 sensitivity and 99 1 specificity Animal Study In addition pre clinical animal testing was conducted on seven 7 pigs domestic crossbreeds weighing 14 to 24 kg using the Powerheart AED with model 9730 pediatric electrodes Testing showed the Cardiac Science pediatric waveform demonstrated excellent performance in shock efficacy in resuscitation of pigs with a short duration of ventricular fibrillation Out of the 7 pigs tested 5 were defibrillated with the first shock and the remaining 2 were defibrillated on the second shock This data was previously presented in the original premarket notification submission Although the pre clinical animal study was not specifically designed to analyze the algorithm 16 analysis cycles 1 Cecchin et al Is Arrhythmia Detection by Automatic External Defibrillation Accurate for Children Sensitivity and Specificity of an AED Algorithm in 696 Pediatric Arrhythmias Circulation 2001 103 2483 2488 May 22 2001 112 2013 003 A 11 Summary of RHYTHM x Clinical Results were obtained from the test data and all results showed that the algorithm performed as intended Conclusions The RHYTHMX analysis algorithm has a proven history of
9. tionally Cardiac Science has evaluated the performance of the Powerheart AED using adult clinical waveforms from separate databases these testing results have been previously submitted and reviewed by FDA and are summarized as follows Database testing utilizing 3 396 episodes of non shockable and 289 episodes of shockable rhythms from the MIT and AHA databases The Powerheart AED using the RHYTHMXx algorithm demonstrated 99 sensitivity and 99 4 specificity Database testing utilizing 1 626 episodes of non shockable and 66 shockable rhythms obtained from Cardiac Sciences previous testing of the RHYTHM Xx software algorithm conducted under IDE G920078 demonstrated that the 112 2013 003 A Summary of RHYTHMx Clinical Results RHYTHMXx algorithm detected all rhythm types with 100 sensitivity and 100 specificity Due to the rare incidence of pediatric defibrillation it is very difficult to perform prospective and statistically significant defibrillation clinical trials on children to test for shock efficacy using actual shocks Other studies have demonstrated that pediatric patients can be effectively treated with standard adult defibrillation algorithms Consequently the focus of Cardiac Science s performance testing has been to demonstrate the safety of the Powerheart AED with the pediatric attenuation electrodes Cardiac Science performed a database analysis of the Powerheart AED with the pediatric attenuation electrodes using t
10. to sustain high rate heart rhythms The two distinct default rate settings allow for a broader spectrum of heart rate analysis particularly for pediatric ECG rhythms which have higher perfusing rates than adult ECG rhythms Using Cardiac Science s MDLink software the Medical Director can pre program shock analysis rates between 140 BPM to 240 BPM or has the option to disable the SVT analysis function 112 2013 003 A 9 Pediatric Reduced Energy Defibrillation Electrodes Instructions for Use 10 Pediatric Attenuator Design The pediatric defibrillation electrode pads include a pediatric attenuator as an integral part of the design The attenuator is designed to absorb a portion of the energy delivered to the child infant When the Powerheart AED energy protocol setting is programmed to the Non Escalating Low Energy Option 200VE 200VE 200VE the defibrillation energy will be reduced to 50 when the pediatric electrodes are used The pediatric attenuator is specifically designed to not have an impact to the ECG analysis The RHYTHMx algorithm is specifically designed to be tolerant of a wide range of signal amplitudes and impedances Performance testing has been conducted to demonstrate that the addition of the pediatric electrodes attenuator when used with the Powerheart AED has no significant effect on the ECG waveform Adult and Pediatric Database Testing The Powerheart AED has extensive clinical use in adult applications Addi
11. uced Energy Defibrillation Electrodes Instructio ns for Use Attenuated Energy Values With Cardiac Science Pediatric Electrode Pads and STAR Biphasic Waveform 1000 800 Typical waveform 600 50J 50 ohm patient impedance 400 200 Ouput Voltage V 200 400 600 12 Time ms 50J All values are typical Phase 1 Phase2 Patient s Impedance Voltage Duration Voltage Duration Energy ohms volts ms volts ms Joules 25 442 6 1 301 3 2 40 50 632 7 3 427 3 2 50 75 738 8 6 489 3 2 51 100 806 9 9 520 3 2 50 125 852 11 1 535 3 2 46 112 2013 003 A Changing the Shock Protocol Changing the Shock Protocol To change the shock protocol you must have the MDLink software installed on your PC MDLink is shipped with your AED on the Quick Start CD ROM Note MDLink is not for use with the FirstSave G3 AED After installing the MDLink software on the PC and connecting the AED use the serial communication cable that was shipped with your AED 1 Click Get AED Configuration 2 Set the Shock Energy Protocol to the last selection 200VE 200VE 200VE Click Set AED Configuration 4 Click Exit This completes the programming of your AED and sets it to the proper protocol when potentially using pediatric electrodes If you have any questions or problems please contact Cardiac Science s 24 hour customer care at 1 800 425 402 2000 or care cardi
12. wer left chest as shown in Figure 1 Figure 1 Standard pads placement recommended 5 Open the AED lid If adult electrode pads are attached to the AED disconnect them before connecting the pediatric pads 112 2013 003 A Instructions for Use 6 Connect the pediatric pads to the AED To attach match 7 8 the connector colors red to red from the pads to the AED and slide together until the connectors are firmly attached The AED begins patient analysis Refer to the AED Operator s and Service Manual for additional operating information Note Pads can be placed in either position on the patient e g either pad can be placed on the chest or back position as shown in Figure 1 standard pads placement Alternative pads placement Figure 2 a Place one pad with the sticky side to the patient s bare skin in the center of the chest as shown in Figure 2 Press the pad firmly to the patient s skin Carefully peel the second pad Figure 2 Alternative away from the liner pads placement Place the second pad on the patient s back as shown in Figure 2 Note Pediatric electrode pads are for short term use only One set of Cardiac Science Pediatric Electrode Pads can be used to monitor a patient for 2 hours and deliver up to 15 shocks To remove electrode pads slowly peel back the edge of the pads away from the patient s skin Dispose of the used pads 112 2013 003 A Pediatric Red
Download Pdf Manuals
Related Search