samaritan® PAD User Manual
Contents
1. 24 6 4 Understandingcheckpatientmode 28 65 POStuSe procedures si A N 0 YL Y L A Y 28 Understanding the samaritan PAD 29 7 1 What is the samaritan PAD eseese 29 7 2 What does the samaritan PAD do sccccssssssssssssssssssessssssessesstssssssesee 29 7 3 Whatis heartrhythm aaa AAA ARANAN 30 7 4 How does the samaritan PAD work nn 30 7 4 1 Whatisbiphasic 31 742 Escalatingenergyprotocol 32 743 Biphasicwaveformspecification6 32 7 5 Howisimpedancemeasured 33 Understanding the samaritan PAD interface35 8 1 Understandingvisualindicator5 35 8 1 1 Statuslindicator 35 8 1 2 Defibrillation PadsConnectionIndicator 36 8 13 ShockButtonlndicator 37 8 14 RescucActionlndicators 37 8 2 Audiblepromptine eee 38 82 1 Audibleindications 38 82 2 VOICE DLOMD LN SEZ eaa ateteki TENESSE aat IE ER ETELE taia Ea 38 9 Recording the samaritan PAD s usage 39 9 1 RecordeddECGinformation 39 92. 10 4 10 5 LA 10 6 Do not immerse any part of the samaritan PAD in water or any type of fluid Contact with fluids may seriously damage the device or cause fire or shock hazard Do not clean the samaritan PAD with abrasive materials cleaners or solvents Storing the device Important points to remember when storing the samaritan PAD are Store the samaritan PAD in a suitable location for easy access Store the samaritan PAD in a clean and dry environment Changing the language You can use Saver to change the language in which the audible prompts are delivered Refer to the Saver User Manual for further information on using Saver to change the samaritan PAD language Battery specifications The battery lifetime can be up to 6 hours monitoring or 30 shocks or a combination of both Unused batteries have a shelf life of 3 years HeartSine Technologies Inc Version 1 0 Page 43 PAD User Manual 11 Accessories for the samaritan PAD Part Number SAM 300 SPP 301 SPS 301 SPS 302 SPS 303 SPS 304 SPS 305 SSS 021 SDU 002 SPD 303 SPT 305 SPT 302 SPT 303 STU 002 Page 44 Unit samaritan PAD Defibrillator samaritan PAD samaritan Pad Pak Battery samaritan Pad Pak includes battery amp 1 set of pads 8yrs Adult Carrying and Mounting Accessories Soft Carry Case Hard Carry Case Recessed Wall Cabinet with Alarm Wall Bracket Vehicle Bracket
3. 4 particular requirements for the safety of cardiac defibrillators including automated external defibillators b Automatic External Defibrillators for Public Access Defibrillation Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance Incorporating New Waveforms and Enhancing Safety and Efficacy AHA Task Force on Automatic External Defibrillation Subcommittee on AED Safety and Efficacy Circulation 1997 Vol 95 1677 1682 AHA and MIT NST databases Page 56 Version 1 0 HeartSine Technologies Inc User Manual PAD V SCOPE Biphasic Waveform Clinical Summary The HeartSine SCOPE Biphasic waveform has been clinically tested in a three phase validation program Numerous animal studies have been conducted to compare the efficacy of the SCOPE biphasic to other defibrillation waveforms Results of these studies have been published Optimization of transthoracic ventricular defibrillation biphasic and triphasic shocks waveform rounding and synchronized shock delivery Kidwai BJ McIntyre A Anderson J Adgey AAJ Journal of Electrocardiology Vol 35 No 3 2002 In addition a Human Clinical Trial has been conducted comparing the SCOPE biphasic waveform to a currently marketed constant energy biphasic defibrillator Biphasic X Results from this study are submitted below PURPOSE To establish the efficacy of conversion of VF VT at low energies with a new biphasic w
4. AED Wall Sign samaritan Data Storage and recall SAVER Data Management amp Review Software Licenses Additional Samaritan PAD Data Recovery Cable Training Systems samartan PAD Trainer with Trainer Pak amp charger Additional Samaritan PAD Trainer PAK Includes Rechargeable battery and trainer pad Replacement Samaritan PAD Trainer defibrillation pads Set of 3 Replacement Samaritan Trainer battery charger Version 1 0 HeartSine Technologies Inc User Manual PAD 12 Troubleshooting This section provides some useful troubleshooting information for samaritan PAD Samaritan PAD indicator is not flashing e Check that a Pad Pak is inserted into the Samaritan PAD e Check that the Pad Pak is correctly inserted When inserting the Pad Pak you will hear a click once it is properly seated e Ifthe unit is properly powered the Status Indicator flashes every 5 seconds Contact support HeartSine com if you find that the device is still not working correctly HeartSine Technologies Inc Version 1 0 Page 45 User Manual PAD 13 Warranty and Repair HeartSine Technologies will provide the following services under this warranty All faulty components which fail due to defective manufacture will be replaced free of charge for the following periods from the original date of purchase samaritan PAD 5 years Pad Pak 3 years HeartSine is responsible for extens
5. Samaritan disposable defibrillation pads are supplied as standard with each device Standard placement anterior lateral Active Gel Area 100 cm2 Cable Length 3 5 ft 1m Shelf Life 3 years HeartSine Technologies Inc Version 1 0 Page 51 PAD Page 52 User Manual SCOPE Biphasic waveform specifications The HeartSine samaritan PAD delivers a Self Compensating Output Pulse Envelope SCOPE biphasic waveform This waveform automatically optimizes the waveform pulse envelope amplitude slope and duration for a wide range of patient impedances from 20 ohms to 230 ohms The delivered waveform to the patient is an optimized impedance compensated biphasic truncated exponential waveform that incorporates an escalating energy protocol of 100 J 150 J 200 J The duration of each phase is automatically adjusted to compensate for varying patient impedances The first phase T1 duration is always equivalent to the second phase T3 duration The interphase pause is always a constant 0 4 msec for all patient impedances The specific SCOPE waveform characteristics for a 100 J pulse are listed below Volts co Duration msec Version 1 0 HeartSine Technologies Inc User Manual PAD Vi Tilt T T 25 1330 63 1 3 3 50 1380 44 1 3 5 3 5 75 1400 42 5 5 5 100 1410 39 3 6 6 125 1420 39 3 7 5 7 5 150 1420 37 6 8 5 8 5 175 1420 39 3 10 5 10 5 200 1420 37
6. ECG monitoring After CPR has been applied you should periodically pause to allow the samaritan PAD to correctly analyze the patient s ECG HeartSine Technologies Inc Version 1 0 Page 31 PAD 7 4 2 B PH yi Page 32 User Manual Escalating energy protocol The samaritan PAD incorporates an escalating energy protocol This is defined by 1 An initial shock delivered at 100 Joules 2 Heart rhythm analysis indicates if further therapy is advised 3 A subsequent two shocks may be delivered at 150 and 200 Joules respectively 4 CPR will be advised after three consecutive shocks have been delivered 5 Heart rhythm analysis indicates if further therapy is advised If further therapy is required the samaritan PAD will continue at 200 Joules following the set CPR protocol until a non shockable rhythm is restored The escalating energy protocol has been configured by the factory Changes of the escalating energy protocols should only be done on the direction of a physician Refer to the Saver user manual for details on changing the energy protocol The samaritan PAD automatically disables energy charging and delivery for one minute at the end of any sequence of three shocks to allow for CPR Biphasic waveform specifications The samaritan PAD generates therapy in the form of a Biphasic truncated exponential wave The patient s impedance is measured and this forms the basis of the Waveform parameter
7. HeartSine Technologies Inc User Manual PAD 2 Warnings A A A A A The samaritan PAD has the capability to deliver therapeutic electrical shocks The electrical shock can cause serious harm to either operators or bystanders Caution must be taken to ensure that neither the operators or bystanders touch the patient when a shock is to be delivered The samaritan PAD has been designed to work on unconscious non responding patients Movement of the patient during analysis of heart rhythm can cause an error or delay in diagnosis Care must be taken to minimise movement of the patient while analysis of their heart rhythm is being carried out Touching the patient during the analysis phase of treatment can cause interference with the diagnostic process Avoid physical contact with the patient until analysis and or treatment has been completed unless the device instructs the operator to perform CPR It has been determined that the samaritan PAD is safe to use in conjunction with oxygen mask delivery systems However due to the danger of explosion it is strongly advised that the samaritan PAD should not be used in the vicinity of explosive gases This includes flammable anaesthetics or concentrated oxygen Only be used on patients greater than 8 years old HeartSine Technologies Inc Version 1 0 Page 9 PAD A A A A Page 10 User Manual Proper placement of the samaritan PAD pads is critical Strict observanc
8. number of charges shocks per use Version 1 0 HeartSine Technologies Inc User Manual PAD 10 Maintaining the samaritanePAD 10 1 This chapter contains the following sub sections e Checking after each use e Monthly checks to perform e Cleaning the device e Storing the device e Changing the language e Battery specifications It is imperative that you maintain the samaritan PAD correctly to ensure that you can rely on the device in times of an emergency The samaritan PAD performs weekly self checks to verify the readiness of the unit Improper maintenance may damage the samaritan PAD or cause malfunction The device must be maintained and cleaned as advised To properly maintain the samaritan PAD you must carry out regular checks e after each use e monthly This section includes instructions for performing these checks and instructions for cleaning and storage Checking after each use The following procedure should be followed each time the samaritan PAD is used 1 Dispose of the existing Pad Pak 2 Use Saver to download information about the therapy performed and erase memory 3 Install anew Pad Pak 4 Check the Status Indicator HeartSine Technologies Inc Version 1 0 Page 41 PAD A 5 6 ds LA 10 2 LA 10 3 Page 42 User Manual If the Status Indicator is not flashing a problem has been detected You should refer to troubleshooting in this manual and or contact H
9. research into the accurate detection and identification of Ventricular Fibrillation and Ventricular Tachycardia The device is therefore highly reliable in advising you when to deliver a shock How does the samaritan PAD work HeartSine and Academia have spent several years researching the analysis of heart rhythms to identify the optimal technique of applying the lowest possible amount of electrical energy in order to resuscitate a victim of SCA The samaritan PAD incorporates an advanced cardiac rhythm detection algorithm and the patented SCOPE biphasic energy delivery system This ensures a high degree of defibrillation efficacy and patient safety The samaritan PAD works as follows 1 The electrical rhythm of the heart is monitored via disposable defibrillation pads 2 The samaritan PAD automatically analyzes the heart rhythm 3 Ifthe samaritan PAD decides the heart rhythm is one of a number of potentially fatal heart arrhythmias the samaritan PAD delivery system is charged and the operator will be advised to shock the patient by pressing the flashing Shock button 4 The samaritan PAD provides the operator with audio and visual prompts These prompts e instruct the operator on the next step when using the device e signal to the operator the current activity of the samaritan PAD Version 1 0 HeartSine Technologies Inc User Manual PAD e warm of any problems that have occurred advise on sa
10. samaritan PAD is always ready for use 1 Ensure that the samaritan PAD is clean and dry 2 Insert a new Pad Pak into the samaritan PAD 3 Check that the Status Indicator is flashing 4 Position the samaritan PAD in a suitable and pre arranged location Understanding the Pad Pak The Pad Pak contains the power source for the samaritan PAD and the defibrillation pads This combined package comes with one expiration date that encompasses the battery and defibrillation pads A The Pad Pak must be installed into the samaritan PAD by the install before date printed on the Pad Pak There is a non rechargeable integrated battery inside each Pad Pak therefore each Pad Pak must be disposed of carefully after use HeartSine Technologies Inc Version 1 0 Page 17 PAD User Manual 4 2 1 Installing the Pad Pak Before you begin to use the samaritan PAD the Pad Pak must be fitted correctly This is easily achieved as the tray can be inserted in only one direction To insert the Pad Pak you Slide the Pad Pak fully into the slot on the underside of the samaritan PAD until it clicks Figure 2 The Inserting the Pad Pak a Once the Pad Pak has been successfully inserted the Status Indicator flashes approximately every 5 seconds Page 18 Version 1 0 HeartSine Technologies Inc User Manual PAD 4 3 gt gt 4 4 1 Ensuring the samaritan PAD is working cor
11. the therapy to be unsuccessful Placing pads on the patient It is essential that the disposable defibrillation pads are connected correctly to the patient It is these pads that monitor the heart and deliver the therapeutic shock treatment To connect the pads to the patient you 1 Pull out defibrillation pads pouch 2 Open the pouch and remove the defibrillation pads HeartSine Technologies Inc Version 1 0 Page 21 PAD User Manual 3 Peel pads one at a time from the protective backing firmly place the pads sticky side down on the patient s bare chest and ensure the pads are completely adhered to the skin 4 Place one pad just below the right collarbone and place the other pad over the patient s ribs in line with the armpit and below the left breast See Figure 3 below XW The correct placement of each pad is clearly illustrated on the Pad Pak A The defibrillation pads must not touch each other This can cause electrical arcing and possible skin burns and may divert defibrillating energy away from the heart Figure 3 Where to place the pads Page 22 Version 1 0 HeartSine Technologies Inc User Manual PAD 6 Using the samaritansPAD This chapter contains the following sub sections e Quick Start e Useful Hints Step by step Instructions Understanding Check Patient Mode e Post use procedure This chapter provides you with all of the instructions that you need to use the samaritan PA
12. 2 Events LOG sccsscscssseecssceceoscecesescescecsecsecesnseis iuseespsneveesy ba so Base GeL SEE 39 Version 1 0 HeartSine Technologies Inc User Manual PAD 93 Otherinformationrecorded 40 10 Maintaining the samaritan PAD 41 10 1 Checking after cach use ankamall akla Kami 41 10 22Monthlycheckstoperform 42 10 3Cleaningthedevice 42 10 4 Storing the devices 050 Fes cacesvescsdssetecutsseeesedscptaseusceuessueests ope riaan 43 10 55Changingthelanguagt 43 LOG Battery Specifications 221111410 L 43 11 Accessories for the samaritan PAD 44 12 Troubleshooting cccceeeeeeeeeeeeeeeeeeeeeeeeeeeeees 45 13 WarrantyandRepair 47 yo oT go E rey KERR ERKE eee 48 i Samaritan PAD technical specificatlon 49 ii SCOPE Biphasic waveform specificatlon 52 iii ECGanalysisdetectionsystemdeseription 54 iv ECG arrhythmia analysisalgorithmperformance 55 v SCOPE BiphasicClinicalSummaly 57 GIOSSALY ve slm sl alda ln sadi sa ag sl e Bags sasi s s god Ya E L 60 aa R A i
13. 9 11 5 11 5 225 1430 38 2 13 13 HeartSine Technologies Inc Version 1 0 Page 53 PAD User Manual iii ECG analysis detection system description The HeartSine samaritan ECG Analysis Detection System has been designed to provide a Shock Advised decision for the following ECG Arrhythmias e Ventricular Fibrillation consisting of peak to peak amplitude of 200 uV e Ventricular Tachycardia consisting of a heart rate 180 BPM and a QRS duration equivalent to gt 0 14 seconds The HeartSine Samaritan ECG Analysis Detection System has been designed to provide a No Shock Advised decision for ECG Arrhythmias consisting of but not limited to e Normal Sinus Rhythm NSR e Supraventricular Tachycardia SVT Bradycardia e Pulseless electrical activity PEA The HeartSine samaritan ECG Analysis Detection System analyzes 4 second segments of the patient s ECG Should 2 contiguous segments of the patient s ECG meet the shockable rhythm criteria then the HeartSine Samaritan PAD shall provide a SHOCK ADVISED audible and visual prompt Should one segment of the patient s ECG meet the non shockable rhythm criteria then the HeartSine samaritan PAD shall provide a NO SHOCK ADVISED audible and visual prompt Even after a SHOCK ADVISED decision is rendered the Samaritan ECG Analysis Detection System continuously assesses the patient s ECG and if the patient s heart rhythm spontaneously r
14. D in an emergency This section has been designed for quick reference in times of emergency but users should also read this section whenever they receive the equipment 6 1 Quick start To use the samaritan PAD you 1 Press the On Off button 2 Pull out the defibrillation pads pouch 3 Open the pouch and remove the defibrillation pads 4 Peel pads from liner and apply pads to patient s bare chest B Refer to section 5 2 Placing pads on the patient of this manual for further details on placing the pads on the patient 5 Follow audio guidance 6 If directed administer therapy by pressing the Shock button HeartSine Technologies Inc Version 1 0 Page 23 PAD User Manual 6 2 Useful hints Don t worry the samaritan PAD will provide audio prompts during the entire procedure Good contact between the defibrillation pads and the patient is essential 6 3 Step by step instructions 1 Press On Off button to turn on samaritan PAD The samaritan PAD is activated and you hear the audio prompt Call for medical assistance Remove clothing from patient s chest to expose bare skin Pull green tab to remove pads samaritan PAD Figure 4 Pull out defibrillation pads pouch Page 24 Version 1 0 HeartSine Technologies Inc User Manual PAD 2 Pull out defibrillation pads pouch 3 Open the pouch remove the defibrillation pads peel pads from liner and apply pads to pat
15. ERE TERRENCE 8 1 1 3 Referencestoothersourcesofinformation 8 14 Lists of instructions amaaan amm l lim Miles 8 lin BULLONSE ea a a la mi asa a lale emma 8 gg ge Ke ee 9 3 Overview of the samaritan PAD 11 Sal e a K ei e 11 3 2 Thesamaritan amp PADcontrols 13 3 3 Samaritan PAD symbol 15 4 Preparing the samaritan PAD for use 17 AN QUICK TASES ost ME EMAN O MA RR EYER KE EE RE AR ME 17 42 UnderstandingthePad Pak M 17 421 lastallingthePad PakTM 18 4 3 Ensuring the samaritan PAD is working cotrecily 19 4 4 Where to place the samaritan PAD eee 19 4 4 1 Electromagnetic mterferencePrecaution 19 4 4 2 TemperaturcandHumidityConstraints 20 5 Preparingthepatient 21 Sl Patient hek Siz eae crearse sedescdecedcdedasedesecdedesest ededecasedesebsvedigns 21 5 2 Placing Pads oni the Patenti isminize seye 21 HeartSine Technologies Inc Version 1 0 Page 1 PAD Page 2 User Manual 6 Usingthesamaritan PAD 23 6 1 Quick stat aa sew kee ae Aaa ANNES 23 0 25 Useful hints os ictece S L NEN SL DE S N N an 24 6 3 Step by stepinstructions
16. HEARTSINE TECHNOLOGIES samaritan PAD User Manual Information in this document is subject to change without notice and does not represent a commitment on behalf of HeartSine Technologies Inc No part of this manual may be reproduced or transmitted in any form or by any means electrical or mechanical including photocopying and recording for any purpose without the express written permission of HeartSine Technologies Inc Copyright 2004 HeartSine Technologies Inc All rights reserved Printed in the United Kingdom samaritan is a registered trademark of HeartSine Technologies Inc Saver and SCOPE are trademarks of HeartSine Technologies Inc All other trademarks and registered trademarks are the property of their respective owners samaritan PAD August 2004 H017 001 010 0 HeartSine Technologies Inc HeartSine Technologies Ltd Worldwide Headguarters European Operations 940 Calle Amanecer Suite E Canberra House San Clemente CA 92673 203 Airport Road West Telephone 1 949 218 0092 Belfast BT3 9ED Fax 1 949 218 0093 Northern Ireland Telephone 44 28 9093 9400 Fax 44 28 9093 9401 Website www HeartSine com Email support HeartSine com User Manual PAD Contents IMC OCUCUION PA 5 1 Overviewofthismanual 7 1 1 Conventionsusedinthismanual 7 LL Noteszand hints sepya mim iie nm sys 7 1 12 Warm i eeren e E
17. aritan PAD is either still performing the self test or the self test has detected one or more errors HeartSine Technologies Inc Version 1 0 Page 35 PAD User Manual A Do not use the samaritan PAD if the Status Indicator is not flashing 8 1 2 Defibrillation Pads Connection Indicator The Defibrillation Pads Connection Indicator is a diagram illustrating a patient and defibrillation pads If the arrows and defibrillation pads on this diagram are illuminated the defibrillation pads are not yet attached or are not attached correctly If the defibrillation pads are attached then only the pads located on the patient s torso in this diagram are illuminated The Defibrillation Pads Connection Indicator is illustrated below Illuminated Arrows and Pads Illuminated pads Figure 5 Defibrillation Pads Connection Indicator Page 36 Version 1 0 HeartSine Technologies Inc User Manual PAD 8 1 3 Shock Button Indicator The Shock button Indicator illuminates If illuminated the samaritan PAD is fully charged and ready to deliver therapy once the Shock button is pressed Be sure to verbally and visually clear the patient before pressing the shock button Figure 6 The Shock button 8 1 4 Rescuer Action Indicators The Rescuer Action Indicators are two diagrams located just below the shock button illustrating a rescuer and a patient The Rescuer Action Indicator is illustrated below o r KN N G AV Sta
18. aveform by demonstrating that the HeartSine samaritan SCOPE is at least equivalent to another clinically marketed constant energy biphasic system Biphasic X METHODS Standard disposable defibrillator pads were used by both devices The shock protocol used by the arrest team followed the hospital standard of care 150J shocks for the Ist 2nd and 3rd shocks on each VF VT episode The samaritan was used to deliver a 1 shock energy of 100J followed by 150J and then 200J for the 2nd and 3rd shocks respectively Any shocks delivered after these first three shocks were at the discretion of the attending physician for either device CPR proceeded as per UK Resuscitation Council Guidelines HeartSine Technologies Inc Version 1 0 Page 57 PAD User Manual DATA COLLECTION The two devices to be compared were utilized on alternate days The responding team arrived at each arrest with the defibrillator appropriate to the day of attendance Inclusion Known or suspected cardiac arrest patients Exclusion Any patient who has already received a thoracic shock therapy prior to the resuscitation team Patients lt 36Kg Patients with do not resuscitate DNR instructions Patients whose cardiac arrest has obviously resulted from a non cardiac cause trauma drowning etc ANALYSIS Each record was interpreted by a qualified cardiologist and annotated to detail each VF VT episode and determine the success or failure of a de
19. dverse Events Requirements The Safe Medical Device Act requires that the defibrillator manufacturer and the FDA be notified of specific adverse events These reporting events pertain to device related death serious injury or illness Who is required to report and what events are considered a reportable event can be found in the U S Federal Regulations 21 CFR 803 If you are unsure of what to do always report any samaritan malfunctions or failures to HeartSine Technologies W The requirement to report these events in the EU incident reporting and Canada mandatory problem reporting is covered in the medical device directive 93 42 EEC and the Canadian medical devices regulations HeartSine Technologies Inc Version 1 0 Page 5 User Manual PAD 1 1 1 Overview of this manual This manual describes how you use the samaritan PAD It helps you to understand the background to the device and provides instructions for performing tasks using the device Conventions used in this manual To draw your attention to certain items of importance in the manual and to help you understand instructions this guide presents particularly important items in a stylised way Conventions are used for the following e notes and hints e warnings e references to other sources of information e lists of instructions e buttons Notes and hints Points worthy of note or that provide you with a hint are shown in italic lettering with a pe
20. dvised by the device When a shock is advised the Shock button is illuminated Electrode Connection Indicator the electrode connection arrows are illuminated when the pads need to be applied to the patient or are not correctly attached Data Port the Data Port is provided so that you can connect the samaritan PAD to a PC computer and download therapy information In order to download information connect the samaritan PAD to your computer using the data recovery cable SPD 303 Saver data management software for the samaritan PAD must be installed on your PC in order to review the event data HeartSine Technologies Inc Version 1 0 Page 13 PAD User Manual 7 DataPort samaritan PAD 2 Status Indicator 6 Electrode Connection Indicator 5 Shock Button 1 On Off Button 4 Pad Pak 3 Speaker Figure 1 The samaritan PAD Controls Page 14 Version 1 0 HeartSine Technologies Inc User Manual PAD 3 3 Samaritan PAD symbols The samaritan PAD device and carry case use certain symbols to represent warnings Depending on the type of danger apparent different symbols are used The table below provides an outline of the different symbols used Meaning This symbol appears on the samaritan PAD and represents a general warning to take care This symbol appears on the samaritan PAD and represents a warning against the danger of electric shock Th
21. e of pad positioning instructions as indicated on the labelling and in training is essential Care must be taken to ensure pads are adhered to the patients skin properly Air pockets between the adhesive pad and skin must be eliminated Failure in pad adhesion may hinder effectiveness of therapy or cause excessive skin burns to the patient if a therapeutic shock is applied Reddening of the skin may appear after use this is normal Periodic as defined in manual checks of this device must be undertaken to ensure among other things that the samaritan PAD is not damaged in any way The Pad Pak is a single use item and must be replaced after the Pad Pak pouch seal has been broken or compromised in any way If damage is suspected the Pad Pak must be replaced immediately This device is to be used by a person trained in the use of the product Version 1 0 HeartSine Technologies Inc User Manual PAD 3 3 1 Overview of the samaritan PAD This section provides you with essential information that you can use to prepare yourself for using the samaritan PAD and as reference information for use while you use the device This section contains chapters such as preparing the patient and provides instructions on how to use the device to deliver therapy Indications for Use The HeartSine samaritan PAD is indicated for use on victims of cardiac arrest who are exhibiting the following signs 1 Unconscious 2 Not Breat
22. eartSine Technologies or your local HeartSine distributor for technical support Check supplies accessories and spares for damage or expiration and replace immediately if any damage or expiration is found Check the exterior of the samaritan PAD for cracks or other signs of damage and contact HeartSine Technologies if any damage is found Check the exterior of the samaritan PAD for dirt or contamination Clean the samaritan PAD if dirt or contamination is found Refer to section 10 3 Cleaning the device of this guide for information on how to clean the samaritan PAD Monthly Checks to perform The following checks should be performed monthly Check supplies accessories and spares for damage or expiration Replace immediately if any damage or expiration is found Check the exterior of the samaritan PAD for cracks or other signs of damage Contact HeartSine Technologies if any damage is found Check the exterior of the samaritan PAD for dirt or contamination Clean the samaritan PAD if dirt or contamination is found Refer to section 10 3 Cleaning the device on page 42 of this guide for information on how to clean the samaritan PAD Cleaning the device To clean the samaritan PAD you e Wipe the samaritan PAD with a soft cloth that has been dampened by one of the following oSoapy water e Isopropyl alcohol 70 solution Version 1 0 HeartSine Technologies Inc User Manual PAD A A
23. er Manual ENVIRONMENTAL Operating Temperature 0 to 50 C 432 to 122 F Storage Temperature 10 to 50 Relative Humidity 5 to 95 non condensing Water Resistance IEC 60529 EN 60529 IP44 Altitude 0 to 15 000 feet 0 4 575 meters Shock MIL STD 810F Method 516 5 Procedure I 40G s Vibration e MIL STD 810F Method 514 5 e Category 4 Truck Transportation US Highways e Category 7 Aircraft Jet 737 amp General Aviation Exposure EMC EN 60601 1 2 Second Edition 2001 Radiated Emissions CISPR11 1997 1A 1999 A2 2001 Group 1 Class B Electrostatic Discharge Immunity EN61000 4 2 1995 8K V A1 1998 A2 2000 RF Immunity EN61000 4 3 1996 80 MHz 2 5 GHz 10V m A1 1998 A2 2000 Magnetic Field Immunity EN61000 4 8 1993 3 A m A1 2000 Aircraft RTCA DO 160D 1997 Section 21 Category M Version 1 0 HeartSine Technologies Inc User Manual PAD EVENT DOCUMENTATION Type Internal memory Memory Capacity 45 minutes of ECG full disclosure and event incident recording Playback Capabilities Custom USB cable directly connected to PC and SAVER windows based data review software Pad Pak BATTERY PACK Pak Shelf Life 3 years Weight 0 44 lbs 0 2kg Size 3 93in x 5 24in x 94in 100mm x 133mm x 24mm BATTERY Type Lithium Manganese Dioxide LiMnO2 18V 0 8 Amp Hrs Capacity gt 30 shocks at 200J or 6 hours of continuous monitoring Standby Life 3 year ELECTRODES pads Electrodes
24. er to the samaritan PAD You open this tray to access the defibrillation pads Biphasic Shock A biphasic shock is an electrical current that is passed through the heart firstly in one direction and then in another Defibrillation Electrodes Defibrillation Electrodes are pads that are connected to the patient s chest in order to administer therapy Electromagnetic Interference Electromagnetic interference is radio interference that may cause erroneous operation of the samaritan PAD Impedance Measurement Impedance measurement is a check that is performed to check the integrity of pad patient contact PAD The PAD is a semi automatic device used for the delivery of external defibrillation therapy to resuscitate victims of sudden cardiac arrest SCA who are unresponsive to stimulus are not breathing or have no detectable pulse Saver Saver is software that can be used in conjunction with the samaritan PAD to retrieve and view information about therapy delivered using the samaritan PAD and to configure the samaritan PAD so that it you can tailor the device to suit your requirements Version 1 0 HeartSine Technologies Inc User Manual PAD SCOPE SCOPE stands for Self Compensating Output Pulse Envelope Waveform This is the biphasic technology developed by HeartSine that is incorporated 7 NK into the samaritan PAD Sinus Rhythm Sinus Rhythm is the normal electrical rhythm by which the
25. ered the samaritan PAD will enter Check Patient Mode and you will here the following prompts Tt is safe to touch the patient Check Airway Check Breathing Check for circulation If needed begin CPR This mode lasts 60 seconds During this period the patient should be reassessed by the rescuer Check for signs of consciousness breathing and circulation If the patient is not breathing CPR should be performed Once the samaritan PAD has completed the Check Patient Mode automated operation of the samaritan PAD will resume If no shock is advised you will hear the following audio prompt No Shock Advised XW If no shock has been advised during any of the three automated shock delivery sequences the samaritan PAD enters Check Patient Mode HeartSine Technologies Inc Version 1 0 Page 27 PAD 6 4 6 5 Page 28 User Manual Understanding check patient mode The samaritan PAD enters Check Patient mode under the following circumstances if the samaritan PAD hasn t delivered or advised a shock after a specific time period determined by the diagnostic algorithm e if the samaritan PAD has delivered three consecutive shocks if the samaritan PAD has charged twice and a shock hasn t been delivered If the samaritan PAD has entered Check Patient mode you hear the following audio prompts Check Airway Check Brea
26. eturns to a non shockable rhythm the samaritan PAD will automatically disarm and advise the operator Page 54 Version 1 0 HeartSine Technologies Inc User Manual PAD iv ECG arrhythmia analysis algorithm performance The HeartSine samaritan ECG Arrhythmia Analysis Algorithm Performance has been extensively evaluated by using the American Heart Association s AHA Database and the Massachusetts Institute of Technology MIT NST database The HeartSine samaritan ECG Arrhythmia Analysis Algorithm Sensitivity and Specificity meets the AAMI DF80 2003 requirements and AHA recommendations The HeartSine samaritan ECG Arrhythmia Analysis Algorithm performance is summarized in the table HeartSine Technologies Inc Version 1 0 Page 55 PAD User Manual 90 One RARA CIRES Performance Performance Sided Lower y Specifications Results Confidence Limit Shockable Rhythm Ventricular Fibrillation VF 1 392 Sensitivity gt 90 VF 95 75 94 75 and Ventricular Tachycardia ne VT Sensitivity gt 75 VT 100 100 Non Shockable Rhythm ifici 9 220s eae 99 80 99 76 Normal Sinus Rhythm NSR NSR Non Shockable Rhythm ifici 9 Ne 100 100 Asystole Non Shockable Rhythm ifici 9 BRE e 99 74 99 68 All other Rhythms NSR No error to measure a Association for the Advancement of Medical Instrumentation DF 80 2003 Standard for Medical electrical equipment part 2
27. fety requirements W All events during the monitoring and delivery of the defibrillation therapy are recorded and stored by the samaritan PAD and can be reviewed later using a PC LA Refer to the Saver software manual for further information on reviewing details of therapy 7 4 1 What is biphasic A biphasic shock involves an electrical current being passed through the heart initially in one direction then in another in order to restart the heart Therapy must not only deliver energy but discharge it in a controlled and clinically effective manner Extensive research and clinical trials have led to the recognition of the biphasic shock as the best definitive therapy for treating victims of cardiac arrest A biphasic shock has been found to be as effective as higher energy monophasic shocks HeartSine have developed the samaritan PAD using SCOPE biphasic technology The Self Compensating Output Pulse Envelope Waveform is incorporated in the samaritan PAD and delivers maximum effective therapy while minimizing any damage that could be caused by excess current SCOPE is able to do this by adjusting the biphasic energy waveform in terms of e slope e amplitude width The above manipulation is based on a patient s impedance and provides the most effective defibrillation for the specific patient Performing Cardiopulmonary Resuscitation CPR on a patient connected to the samaritan PAD may interfere with accurate
28. heart muscle contracts and expands to create blood flow around the body Self test A Self test is a semi automatic test that is used to check that the samaritan PAD is working correctly Ventricular Fibrillation Ventricular Fibrillation is a life threatening heart rhythm that is treatable with the therapy using the samaritan PAD HeartSine Technologies Inc Version 1 0 Page 61 User Manual PAD Index YANIN e EYE ee MER 38 Preparing the samaritan PAD 15 PCy a e AMONG ctarinrtnninnctn a Quick Km leli 15 Biphasic sc sccsccecssesesecstecssecsesespesseeesteceses 57 Quick start a a 21 Constraints Pad Pak Teriperature amp Humidity W gelsene 16 Electromagnetic Imterference 19 Understanding 15 G1OSSALY eeens 60 Recording usage verememe 39 Heart rhythm 30 ECG trace 39 Hints A el A ll 24 Events imam n n 39 Impedance eror esse lee alan 33 inf rmaton recorded eke 40 Language eee 43 e msceecrsceeie 47 MA bee medy a S Da a aaa 17 PAD Step by step instructions 22 Battery Specifications 44 S DDOL sarisi sess sekis sens 45 47 YE IEW OBEN april m Sa C 13 Langugge 44 The samaritan PAD Interface 35 Moamienange yana aiai a Troubleshooting 45 S OLME senalar 43 Using the alar END mar 21 tanding EYE MENE ENER 2 ne gt Visualindicators 35 Whatdoes
29. hing 3 Without Circulation The samaritan PAD is intended for use by personnel who have been trained in its operation Users should have received training in basic life support AED advanced life support or a physician authorized emergency medical response training program The samaritan PAD is not currently indicated for use on children less than 8 years old HeartSine Technologies Inc Version 1 0 Page 11 User Manual PAD 3 2 The samaritan PAD controls This section of the manual contains a brief description of each of the functions on the samaritan PAD This section is a good starting point for new users of the samaritan PAD as it introduces each control on the device and explains their use Figure illustrates each of these controls The controls available on the samaritan PAD are l On Off button Use the On Off button to turn the samaritan PAD on or off Status Indicator this indicator is a green icon that flashes approximately every five seconds when the device is operating correctly When the Status Indicator isn t flashing there is a problem with the device Speaker the device provides audible prompts and information on the status of the device Pad Pak the patient pads and battery are contained in a tray on the underside of the device The pads are attached to the device by a I meter cable Shock button the Shock button can be pressed to deliver a shock when a shock is a
30. ient s bare chest as illustrated The samaritan PAD will continue with audio prompts Peel pads from Liner Apply pads to patient s bare chest as shown in picture Press pads firmly to patient s bare skin LO Refer to section 5 2 Placing pads on the patient for further details on placing the pads on the patient A The Pads Connection Indicator indicates if the pads are attached to the patient If the pads are not attached to the patient you will hear the audio prompts Check Pads If the pads are attached to the patient the samaritan PAD will begin to monitor the patient 4 Assessing the patient When pads are attached to the patient you will hear the audio prompt Assessing heart Rhythm Do not touch the patient HeartSine Technologies Inc Version 1 0 Page 25 PAD User Manual A You must ensure the patient is kept still and that no one is in contact with the patient during analysis and therapy Moving the patient can lead to incorrect or delayed diagnosis 2 Administering a shock If a defibrillation shock is required on the first application to the patient the samaritan PAD will prepare for shock delivery by automatically charging the energy delivery system You will hear the audio prompts Analyzing do not touch the patient Stand clear of patient Shock advised Stand clear of patient Verbally and visually clear the pa
31. ions of the warranty period only when specifically agreed between HeartSine Technologies and the distributor A Please Note HeartSine Technologies or the distributor are not obliged to carry out service under warranty if Unauthorized modifications have been made to the device Non standard components are used The user has not used the device in accordance with the instructions provided in this manual The serial number of the apparatus is removed defaced misused or altered The device pads or batteries are stored or used operationally outside of environmentally specified conditions listed within this manual Defibrillation pad packaging is not returned Any claims made under warranty must be directed via the distributor from whom the device was originally purchased The distributor before carrying out service under warranty may require evidence of purchase The product must be used in accordance with the user manual and for the purpose that it was intended If you have a query please contact support HeartSine com for assistance HeartSine Technologies Inc Version 1 0 Page 47 PAD User Manual Appendix This chapter contains the following sub sections e samaritan PAD technical specifications e SCOPE Biphasic waveform specifications e ECG analysis detection system description e ECG arrhythmia analysis algorithm performance e SCOPE Biphasic waveform Clinical Summary Page 48 Version 1 0 Hear
32. is activated a new session begins and the data recorded during this session is retrievable via Saver Refer to the Saver user manual for information on retrieving information saved by the samaritan PAD The three types of information the Event Recording System records are ECG information events that occur during the therapy and other information such as date time and serial number This chapter provides information on each of these different types of information Recorded ECG information The samaritan PAD is able to record the electrical activity of the heart ECG before during and after therapy A clear indication of the heart s activity is given Transience and other adverse effects are suppressed Events log The samaritan PAD recording system can record events that take place during the therapy session The time and date is stored with each event HeartSine Technologies Inc Version 1 0 Page 39 PAD User Manual The types of events that can be recorded are buttons pressed power up monitoring charging therapy delivery charge disarm self test shut down error codes the error code associated with any error messages 9 3 Other information recorded Other information specific to the particular samaritan PAD and battery pack is recorded for reference The types of specific information stored are Page 40 time date samaritan PAD serial number operating software revision number
33. is symbol appears on the samaritan PAD and represents a warning against the danger of explosion This symbol appears on the samaritan PAD and represents a reference to the user manual This symbol appears on the battery and is a warning not to recharge the battery This symbol appears on the battery and is a warning not to short circuit the battery This symbol appears on the battery and is a warning not to crush or puncture the battery This symbol appears on the battery and is a warning not to overheat the battery This symbol appears on the battery and is a warning not to incinerate the battery ISKOLDE er that the samaritan PAD uses a defibrillation protected x This symbol appears on the samaritan PAD and indicates Type BF patient connection HeartSine Technologies Inc Version 1 0 Page 15 User Manual PAD 4 Preparing the samaritan PAD for use 4 1 4 2 This chapter contains the following sub sections e uick list e Understanding the Pad Pak e Ensuring the samaritan PAD is working correctly e Where to place the samaritan PAD It is imperative that the samaritan PAD is always prepared for operational use since it is designed for use in emergency situations This section provides you with information that will help you ensure that the device is always ready for emergency use Quick list Ensure that you follow this quick list to ensure that the
34. itdo 29 Volume 37 What isit seescscsrocstecsuves cocsgeespesyecsees 29 Marie 13 45 Wheretoplace 17 anali 49 Patient a Waveform specifications 55 CHE CkIISts sereni eee b 19 Electrodes pads 19 33 Prepaus 19 HeartSine Technologies Inc Version 1 0 Page 63 Worldwide H eadquarters H eartsine Technologies Inc 940 Calle Amanecer Suite E San Clemente CA 92673 Td 1 949 218 0092 Fax 1 949 218 0093 M anufactured by H eartSine Technologies Ltd Canberra H ouse 203 Airport Road West Belfast BT 3 9ED Northern Ireland Td 44 0 28 9093 9400 Fax 44 0 28 9093 9401 support heartsine com www heartsine com CE 0120 H017 001 010 0
35. ivered in order to customize the delivery pattern to the requirements of the individual patient HeartSine Technologies Inc Version 1 0 Page 33 User Manual PAD 8 Understanding the samaritane PAD interface This section contains the following sub sections Understanding visual indicators e Audible prompting The samaritan PAD provides audio and visual indicators that the operator must be able to see hear and understand to use the device correctly This chapter provides you with the information required to successfully understand and interpret the samaritan PAD interface 8 1 Understanding visual indicators The samaritan PAD employs three different indicators in order to signal that something is wrong or to tell you the status of the device These are the e Status Indicator e Defibrillation Pads Connection Indicator e Shock button Indicator e Rescuer Action Indicator This section provides you with information on understanding the messages conveyed by each of these indicators 8 1 1 Status Indicator The Status Indicator is located on the face of the samaritan PAD The Status Indicator verifies that the samaritan PAD is operating correctly The Status Indicator can be interpreted in the following ways e if the Status Indicator is flashing the Pad Pak is inserted correctly and f samaritan PAD is operating correctly and ready for use e ifthe Status Indicator is not flashing the sam
36. mperature and humidity constraints Successful operation and storage of the samaritan PAD is restricted by important environmental factors Operating during operation of the samaritan PAD the temperature must be between 0 to 50 C with relative humidity non condensing between 5 to 95 Storage amp Transport during storage of the samaritan PAD temperature must be between 100 and 500 C between 5 and 95 non condensation Version 1 0 HeartSine Technologies Inc User Manual PAD 5 5 1 5 2 Preparing the patient This chapter contains the following sub sections e Patient checklist e Placing pads on the patient It is imperative that the patient is fully prepared prior to the use of the samaritan PAD This chapter provides you with instructions that you should follow to ensure that they are ready to receive therapy Patient checklist When preparing the patient for therapy you should use the checklist below to ensure that patient is correctly prepared Important points to remember when preparing the patient are 1 Dry the patient s chest and remove excessive hair 2 Ensure the disposable defibrillation pads are properly attached to the patient s skin 3 Ensure the patient is not in contact with metal objects 4 Remove any non defibrillator proof equipment attached to the patient Delivering a shock to a patient that is not adequately prepared can have fatal consequences or may cause
37. ncil symbol to bring them to your attention for example The samaritan PAD will automatically disable energy charging and delivery for one minute at the end of any sequence of three automated deliveries to allow for CPR Warnings Warnings are shown in bold lettering with a red triangle and exclamation mark to bring them to your attention for example A To safeguard against interference you must operate the samaritan PAD at least 2 meters 6 feet away from all RF devices and other susceptible equipment Alternatively switch off the equipment affected by or causing the Electromagnetic Interference HeartSine Technologies Inc Version 1 0 Page 7 PAD 1 1 5 Page 8 User Manual References to other sources of information References to other sources of information are shown in sans serif lettering with a book symbol to bring them to your attention for example Refer to the Saver online help for further information about configuring the samaritan PAD Lists of instructions Instructions that you must follow in a sequential order are shown in a numbered list for example 1 Open the Pad Pak and ensure that pads cable and connector are undamaged 2 Use the On Off button to turn the samaritan PAD on or off 3 Apply pads to patient s bare chest Buttons Device buttons are shown in bold sans serif lettering with initial capital letters for example e Press the Shock button Version 1 0
38. nd Clear It s Ok to touch the patient when illuminated when illuminated Figure 7 Rescuer Action Indicator HeartSine Technologies Inc Version 1 0 Page 37 PAD 8 2 8 2 1 8 2 2 Page 38 User Manual Audible prompting The samaritan PAD employs two types of audible prompting e Audible indications such as a short tone to indicate that the device has powered on e Voice prompting such as instructions or warnings Audible indications An audible indication is used to alert you when the device has been powered up When the On Off button is pressed the samaritan PAD emits a short audible tone to indicate that power has been applied Voice prompting The samaritan PAD features a voice prompt to guide the user Voice messages are used to provide the following types of information e Incorrect use e o Progress e Instructions e Warnings Version 1 0 HeartSine Technologies Inc User Manual PAD 9 9 1 9 2 Recording the samaritansPAD s usage This section contains the following sub sections Recorded ECG information Events log Other information recorded A sophisticated event recording system is automatically started each time the samaritan PAD is powered on The samaritan PAD can hold all the information gathered during a session of therapy without the need for retrieval The samaritan PAD can record up to 45 minutes of ECG therapy Each time the samaritan PAD
39. rectly The samaritan PAD automatically performs a weekly self test to ensure that the device is working correctly If the Status Indicator is not flashing the device is not working correctly If the Status Indicator is not flashing a problem has been detected You should refer to troubleshooting in this manual and or contact HeartSine Technologies or your local HeartSine distributor for technical support Where to place the samaritan PAD The samaritan PAD should be placed in an easily accessible location when in use The Status Indicator must be clearly visible The samaritan PAD must be stored with a Pad Pak installed The samaritan PAD must not be used or stored in the presence of flammable agents or oxygen enriched atmospheres Electromagnetic Interference Precaution The samaritan PAD has successfully passed stringent electromagnetic interference tests However devices such as cellular phones and two way radios may cause the samaritan PAD to operate erroneously due to radio frequency interference RFI The samaritan PAD may also adversely affect other susceptible equipment To safeguard against interference you must operate the samaritan PAD at least 2 meters 6 feet away from all RF devices and other susceptible equipment Alternatively switch off the equipment affected by or causing the Electromagnetic Interference HeartSine Technologies Inc Version 1 0 Page 19 PAD Page 20 User Manual Te
40. s which are adjusted by the samaritan PAD before therapy The samaritan PAD charges the internal storage capacitors to a selected level The output pulse phase is adjusted to ensure delivery of the selected level of energy Phase A and Phase B of the output pulse envelope are always of the same duration Version 1 0 HeartSine Technologies Inc User Manual PAD 7 5 How is impedance measured An impedance measurement is performed when the samaritan PAD is switched on This measurement is important for the following reasons e It checks the integrity of the electrode patient contact and of the electrode leads If the impedance is too high electrode patient contact is poor If the impedance is too low the pads may be touching each other e It is used to adjust the Biphasic Waveform parameters to ensure optimum efficacy of the therapy When the samaritan PAD is switched on 1 The patient pad impedance is measured and the samaritan PAD determines if the pads are correctly connected to the patient 2 Ifa problem is found the samaritan PAD will alert the operator and further use of the defibrillator will be disabled until the problem is corrected Measurement of the impedance level is continuous Therapy cannot be delivered if proper connection between the pads and patients is lost at any stage The impedance value is used to determine some of the primary parameters of the waveform of the energy that is del
41. should not be used on children under 8 years of age What does the samaritan PAD do The samaritan PAD provides the rapid application of defibrillation therapy the only definitive treatment for potentially fatal heart arrhythmias When the disposable defibrillation pads are properly applied to the patient s chest and the samaritan PAD is used the device e monitors heart rhythm e advises whether or not therapy should be applied by providing audio instructions e delivers therapy using a carefully defined electrical shock designed to stop the chaotic electrical activity experienced within the heart muscle during SCA and return the heart to a normal rhythm HeartSine Technologies Inc Version 1 0 Page 29 PAD 7 3 7 4 Page 30 User Manual What is heart rhythm The normal electrical rhythm by which the heart muscle contracts and expands to create blood flow around the body is known as Sinus Rhythm When an individual suffers a sudden cardiac arrest SCA the heart may lose this rhythm and cease pumping This results in a life threatening but shockable rhythm Ventricular Fibrillation VF An electrical shock can be administered to re establish normal sinus rhythm Shock therapy should be used only when appropriate Therapy can result in injury or death to the patient if delivered when it is not required The samaritan PAD embeds cardiac rhythm software This software has been developed through many years of
42. strict 63 HeartSine Technologies Inc Version 1 0 Page 3 User Manual PAD Introduction This section introduces you to the samaritan PAD user manual This manual explains how you use the samaritan PAD PAD stands for Public Access Defibrillator The samaritan PAD is a semi automatic device used for the delivery of external defibrillation therapy to resuscitate victims of sudden cardiac arrest SCA who are unresponsive to stimulus are not breathing or have no detectable pulse The samaritan PAD is designed for infrequent use The samaritan PAD can also be used in conjunction with the Saver data management system Saver data management software is used to configure and to review the use of the samaritan PAD Information about Saver data management software is provided in the separate Saver user manual za Note United States Federal Law restricts the use of this device by or on the order of a physician Regulatory Requirements Defibrillator Tracking Requirements The U S Federal Regulations 21 CFR 821 requires that manufacturers of defibrillators track the location of each defibrillator it manufactures This regulation further requires that each purchaser or owner of a defibrillator notify the manufacture if the product is lost stolen or destroyed If the defibrillator changes ownership either by donation reselling or distribution the manufacturer must be notified of the new location Notification of A
43. tSine Technologies Inc User Manual PAD i Samaritan PAD Technical specifications PHYSICAL Size 8 0in x 7 25in x 1 9in 20mm x 18 4mm x 4 8mm Weight 1 1kg 2 4 lbs including Pad Pak Battery DEFIBRILLATOR Waveform SCOPE self compensating output pulse envelope Biphasic Escalating waveform Optimized biphasic waveform compensates energy slope and envelope for patient impedance Energy Selection Pre configured automated protocol escalating from 100J 150J to 200J Charge Time 100J in less than 7 seconds and 200J in less than 12 seconds 200J from a SA message with new Pad Pak Shock Cycle Time lt 60 seconds for three analyze shock cycles Controls Shock On Off PATIENT ANALYSIS SYSTEM Method Evaluates patient s ECG signal quality electrode contact integrity and patient impedance to determine if defibrillation is required Sensitivity Specificity Meets AAMI DF 80 requirements DISPLAY Visual Prompts Attach Pads Stand Clear Perform CPR Shock Now Self tests Pass Ready State Indicators Low battery voice prompt at least 10 discharges remaining audible prompt alerts user of electrode disconnect service icon stops flashing if self tests fail no battery or when service required Voice and icon prompts Extensive voice and icon prompts guide the user through the operation sequence Languages English HeartSine Technologies Inc Version 1 0 Page 49 PAD Page 50 Us
44. thing Check for circulation If needed begin CPR At this stage you can perform CPR on the patient if required After 1 minute has elapsed you hear the audio prompt Stop CPR The device returns to Monitoring Mode Post Use Procedure Once therapy is completed power off the device and replace Pad Pak 1 Press On off button to turn samaritan PAD off 2 Completely remove the Pad Pak from the samaritan PAD and dispose of it safely 3 Clean the samaritan PAD properly as described in the Cleaning and Maintenance section of this manual 4 Insert anew Pad Pak in the samaritan PAD 5 Check the Status Indicator 6 Position the samaritan PAD in a suitable and pre arranged location Version 1 0 HeartSine Technologies Inc User Manual PAD Ti 7 1 7 2 Understanding the samaritan PAD This chapter contains the following sub sections e What is the samaritan PAD What does the samaritan PAD do e What is heart rhythm How does the samaritan PAD work e How is impedance measured What is the samaritan PAD PAD stands for Public Access Defibrillator The samaritan PAD is a semi automatic device used for the delivery of external defibrillation therapy to resuscitate victims of sudden cardiac arrest SCA who are unresponsive to stimulus are not breathing or have no detectable pulse The samaritan PAD is designed for infrequent use The samaritan PAD
45. tient Once the samaritan PAD is charged you will see the Shock button flashing and hear the audio prompts Press the Shock button now Press the Shock button now Visually and verbally CLEAR the patient Ensure no one is in contact with the patient Then Press the Shock button to deliver the therapy A Do not touch the patient while defibrillation therapy is in process Page 26 Defibrillation energy can cause injury The patient s heart rhythm will automatically be analyzed to determine if the shock was successful For safety precautions if the Shock button is not pressed within 30 seconds after recommendation the device will disarm and resume analyzing the patient s heart rhythm Version 1 0 HeartSine Technologies Inc User Manual PAD Follow the audio instructions to repeat therapy if the initial shock was unsuccessful XS The samaritan PAD uses an escalating energy protocol to provide the Shock If the initial shock is unsuccessful the device will use the next highest energy level that has been specified in the configuration of the samaritan PAD to deliver another shock It is possible to adjust this protocol using the HeartSine Saver software Please refer to the Saver User Manual for instructions LA Refer to Section 7 4 2 Escalating energy protocol for further information on this feature Check Patient Mode After a successful shock or after three shocks have been deliv
46. vice to terminate the arrhythmia Successful defibrillation was defined as termination of VF for gt 5 seconds or termination of other shockable Ventricular Tachyarrhythmia for gt 5 seconds Any subsequent recurrence was defined as a new episode Page 58 Version 1 0 HeartSine Technologies Inc User Manual PAD RESULTS Total number of patients HeartSine samaritan 8 Biphasic X 23 VF Summary HeartSine Biphasic samaritan y Parameter Total number of episodes 28 0 100 0 62 0 100 0 Total number of successful shocks 28 0 66 7 61 0 39 4 Total number of unsuccessful 14 0 33 3 94 0 60 6 shocks Success within 1 shock 18 0 64 3 36 0 58 1 Success within 2 shocks 24 0 85 7 43 0 69 4 Success within 3 shocks 28 0 100 0 48 0 77 4 Average number of shocks required ka 2 5 Average energy required J 125 0 150 0 Average energy reduction J 25 0 16 6 SUMMARY The initial results from the Human Clinical trial shows that the HeartSine SCOPE biphasic waveform is at least as effective as the other marketed constant energy biphasic waveform system HeartSine Technologies Inc Version 1 0 Page 59 PAD Page 60 User Manual Glossary Pad Pak The Pad Pak is a tray that fits into the samaritan PAD This pack contains the defibrillation pads that you must connect to the patient s chest and the battery that supplies pow
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