User Manual (H017-001-300-3)
Contents
1. samaritan PAD SAM3O00P USERS MANUAL TABLE OF CONTENTS Introduction Sudden Cardiac Arrest Heart Rhythm Detecting Fibrillation Training Intended Users samaritan PAD model sam300P configuration CPR Guidelines 2005 Your samaritan PAD Unpacking your samaritan PAD samaritan PAD Features Please Note samaritan PAD features Preparing your samaritan PAD for Use Installation Where to Store your samaritan PAD Maintenance Self Test Status Indicator When to replace the Pad Pak How to replace the Pad Pak Storage Temperature When to use the samaritan PAD When to use the samaritan PAD Pre Defibrillation Action Adult or pediatric patient CPR Fundamentals CPR with defibrillation fundamentals Performing Defibrillation Step by Step Introduction Incident Notification After Using the samaritan PAD Post use checklist Disposal instructions Troubleshooting Fault identification Warnings and precautions Technical Data Scope Biphasic Waveform Clinical Results Electromagnetic Emmissions Glossary Abbreviations OOO WO ooo N DOMDNDOH A HB WWW W W amp Icons used in this manual Note Warning Voice Prompt To do ABOUT THIS EDITION The information in this manual applies to the HeartSine Technologies samaritan PAD sam300P automatic external defibrillator Information in this document is subject to change without notice and does not represent a commitment on behal2. 0 to 50 C 32 to 122 F 10 to 50 C 50 to 122 F 10 to 50 C 14 to 122 F for up to two days 5 to 95 non condensing IEC 60529 EN 60529 IP56 0 to 15 000 feet 0 4 575 meters MIL STD 810F Method 516 5 Procedure 40G s MIL STD 810F Method 514 5 Category 4 Truck Transportation US Highways MIL STD 810F Method 514 5 Category 7Aircraft Jet 737 amp General Aviation EN 60601 1 2 2002 EN55 11 1999 A2 2001 EN61000 4 2 2001 8kV EN61000 4 3 2001 80MHz 2 5GHz 10V m EN61000 4 8 2001 3 A m RTCA DO 160D 1997 Section 21 Category M TSO C142 RTCA DO 227 Disposable single use combined battery and defibrillation electrode cartridge Check expiration date typically 3 2 years from manufacture 0 44 Ibs 0 2kg 3 93in x 5 24in x 0 94in 10cm x 13 3cm x 2 4cm Lithium Manganese Dioxide LiMnO2 18V 0 8 Amp Hrs gt 30 shocks at 200J or 6 hours of continuous monitoring Check expiration date typically 31 2 years from manufacture For use on patients over eight years old and 25Kg 55 Ib in weight Single Pad Pak supplied as standard with every samaritan PAD Single use pre attached combined ECG sensor Defibrillation electrodes Anterior lateral 100cm 1m 3 5 ft Check expiration date typically 3 2 years from manufacture For use on patients over one year old and under eight years old weighing less than 25kg 551b Available as an optional accessory Single use pre attached combined ECG sens
3. F In this situation the device can be safely used in the lower temperature range for a period of up to 1 hour after it has been exposed to the lower temperature When using the samaritan PAD in low temperature conditions HeartSine recommend that it is not exposed to the lower temperatures until it is about to be used The samaritan PAD is not intended to be used in ambient temperatures below 0 C 32 F or above 50 C 122 F sam300P user manual samaritan PAD SOFT CARRY CASE The samaritan PAD and samaritan PAD soft carry case have been designed to allow the rescuer to use the samaritan PAD without having to open the carry case e FRONT a A clear plastic cover protects the samaritan PAD while allowing the rescuer to operate the unit If your samaritan PAD is stored in the soft carry case itis not necessary to remove it from the case to operate it AY Pull GREEN tab to expose electrodes package BACK Clear window for quick start card CLEANING YOUR samaritan PAD To clean the samaritan PAD wipe the device with a soft cloth that has been dampened by one of the following gt Soapy water Isopropyl alcohol 70 solution or any type of fluid Contact with fluids may seriously A Do not immerse any part of the samaritan PAD in water damage the device or cause fire or shock hazard Do not clean the samaritan PAD with abrasive materials cleaners or solvents 11 When to use
4. performed prior to seeking the advice of a physician In order to properly diagnose this condition HeartSine recommends that all potential users of the samaritan PAD as a minimum are fully trained in cardiopulmonary resuscitation CPR basic life support BLS and in particular the use of an Automated External Defibrillator specifically the samaritan PAD It is also recommended that this training be kept up to date by means of regular refresher courses as and when recommended by your training provider If potential users of the samaritan PAD are not trained in these techniques contact your HeartSine distributor or HeartSine directly either of whom can arrange for training to be provided Alternatively contact your local government health department for information on certified training organisations in your region sam300P user manual INTENDED USERS The samaritan PAD is intended for use by those who have been trained in its operation It is highly recommended that any potential user receives training in cardiopulmonary resuscitation CPR emergency a care ECC and or the use of an AED specifically the use of the samaritan PAD Many training organizations offer a course that combines CPR and defibrillator CPR D use Course lengths and detail covered vary but most basic courses can be completed in one day For information on how to get training contact your local authorised distributor or HeartSine Technologies directly
5. state and local requirements Alternatively return the unit to your local dealer or HeartSine Technologies for disposal Within the European Union Do not dispose of the PAD unit as unsorted municipal waste Collect the PAD separately to be reused or recycled in accordance with Directive 2002 96 EEC of the European Parliament and the Council of the European Union on Waste Electronic and Electrical Equipment WEEE or return to your local dealer or HeartSine Technologies for disposal Pad Pak The Pad Pak is a single use accessory and must be replaced after use or when its expiry date has been exceeded The Pad Pak may be disposed of in accordance with the instructions for the PAD unit however special consideration must be given to the battery and defibrillation electrodes contained within the device Battery The Pad Pak battery must be recycled separately in accordance with your national state and local regulations or return to your local dealer or HeartSine for disposal Electrodes When disposing of a used Pad Pak the defibrillation electrodes may be contaminated with human bodily tissue fluid or blood Cut the electrode wires The electrodes should be controlled and disposed of as infectious waste material Dispose of this material in accordance with your national state and local regulations If the Pad Pak electrodes have not been used they may be considered non infectious waste www HeartSine com F
6. the actions that the user should be performing Preparing your samaritane PAD for use PAD PAK INSTALLATION The Pad Pak includes the battery and defibrillation electrodes in one cartridge See expiry date for both on label INSTALL 1 Remove Pad Pak from its packaging Place the samaritan PAD and the Pad Pak on a flat surface Push Pad Pak into the opening and listen for the click sound to ensure it is properly inserted Once the Pad Pak is installed properly the PAD STATUS INDICATOR will begin to blink Green every 5 seconds Do not open Pad Pak tray or open defibrillation pads Ee protective packaging until the time of emergency use when they are applied to a patient INSTALL 2 INSTALL 3 CHECK DEVICE is working optimally gt PUSH the ON Button Ensure you can hear the voice prompts ag Adult patient or Child patient if CALL for medical assistance gt Switch OFF by pressing the Button Place the samaritan PAD into its Soft Carry Case For alternative transport cases ask HeartSine or your distributor STALL Put into a wall case or safe visible location Wall cases differ in some countries Ask HeartSine or your authorised distributor The samaritan PAD should be kept in a convenient central area Place it near a telephone so that the rescuer can call emergency medical services and retrieve the samaritan PAD without wasting time Some important poi
7. the samaritan PAD WHEN TO USE THE samaritan PAD The HeartSine samaritan PAD is designed for the treatment of sudden cardiac arrest SCA It should only be used to treat someone who may be a victim of a SCA and is gt unresponsive to stimulus b gt not breathing normally D gt no apparent circulation If the person is unresponsive but you are unsure that they have suffered from a SCA begin CPR When appropriate apply the defibrillator and follow the audible instructions A The samaritan PAD has been designed to work on unconscious non responding patients If the patient is responsive or conscious do not use the samaritan PAD to provide treatment PRE DEFIBRILLATION ACTIONS Prior to using a Samaritan PAD it is advised to perform the following checks and actions in order to prepare the patient gt Determine if the person may have suffered a sudden cardiac arrest Remove clothing to expose bare chest All clothing must be removed including undergarments If excessively hairy shave hair from the areas to which the defibrillation pads are to be applied Ensure that the patients chest is dry If necessary dry the chest area Ensure no rescuers or bystanders are in contact with the patient while the samaritan PAD is assessing the patients heart rhythm or while defibrillation shock is being applied 12 www HeartSine com ADULT OR PEDIATRIC CHILD PATIENT The samaritan PAD SAM300P is capable of pro
8. 6 Ensure no one is in contact with the patient and proceed as before D gt Follow the voice prompts until the emergency medical services arrive Ee Your HeartSine dealer will have trained you in the particular SCA treatment protocol you have chosen In all cases follow the audio and visual prompts given by your PAD sam300P user manual 17 After using the samaritan PAD POST USE CHECKLIST After using your samaritan PAD HeartSine Technologies recommend you perform the following actions 1 Use Saver EVO software to download information about the therapy performed and store appropriately If you do not have Saver EVO software please contact your dealer who can arrange for the incident to be downloaded After downloading the defibrillation event data erase the memory of your samaritan PAD 2 Remove the used Pad Pak from your samaritan PAD and dispose of in a suitable manner For recommended disposal methods please refer to disposal instructions section 3 Check the exterior of the samaritan PAD for cracks or other signs of damage Contact your distributor or HeartSine Technologies immediately if any damage is found 4 Check the exterior of the samaritan PAD for dirt or contamination If needed clean device with approved cleaning products 5 Check supplies accessories and spares for damage or expiration Replace immediately if any damage or expiration is found Contact your local HeartSine approv
9. AULT IDENITIFICATION If the samaritan PAD detects a problem it will indicate to the user that there may be a problem by two ways Status indicator see maintenance section for details This should flash GREEN once every five seconds If it is not flashing there may be a problem Refer to troubleshooting section for further advice Warning message While turned on the samaritan PAD may play audible warning messages to indicate that there may be a problem These messages are nd Warning Memory Full This message indicates that the memory for the event recording facility on the samaritan PAD is full The therapeutic capabilities of the device will be in unaffected but it will no longer be able to record information for any incident it is used in If you hear this message during an emergency response continue to use the samaritan PAD until emergency services arrive Warning Low battery This message indicates that the battery in the Pad Pak may have less than ten defibrillation shocks left If you hear this message during an emergency response continue to use the samaritan PAD until emergency services arrive If available prepare the spare Pad Pak for use and be prepared to change it quickly d Warning Device service required This warning indicates that the samaritan PAD has detected a fault Contact your authorised distributor or HeartSine Technologies directly for further instruction If you hear this mes
10. HeartSine Technologies recommend that users are trained A in Cardiopulmonary Resuscitation with Defibrillator use CPR D Check with local government health department for A information about any requirements associated with ownership and use of a defibrillator in the region where it is to be used Store this manual with the samaritan PAD it will fit into the back section of the soft carry case Ensure all potential users of the samaritan PAD have read this manual and are familiar with its operation Within the United States of America only Within the United States of America federal U S law A restricts this device to sale by or on the order of a licensed practitioner WARRANTY REGISTRATION Under the Medical Devices Regulations we are required to track the location of all medical devices sold It is important that you complete the Warranty Registration card with your details and return to your authorised distributor or HeartSine Technologies directly Your participation will allow us to contact you in the event of important notifications about the HeartSine samaritan PAD such as any future software updates or field safety corrective actions Please complete the Warranty Registration card included with the samaritan PAD Registration is required to validate the product warranty The information provided will be kept strictly confidential and will not be shared with other companies samaritan _ PAD model SAM300P config
11. ONS CPR Cardiopulmonary resuscitation CPR D Cardiopulmonary resuscitation Defibrillation SCA Sudden cardiac arrest VF Ventricular Fibrillation BLS Basic Life Support ACLS Advanced Cardiac Life Support 27 HeartSine Worldwide Headquarters HeartSine Technologies Inc 105 Terry Drive nberr Newtown PA 18940 203 Airport R USA Belfast BT Tel 1 215 860 8100 Fax 1 215 860 8192 Authorised Distributor support heartsine com H017 001 300 3 English www heartsine com October 2008
12. Pad Pak has exceeded its use by date remove it from the Lot No samaritan PAD and replace with a new Pad Pak 143 Contact your local authorised HeartSine distributor for replacements 3 Check supplies accessories and spares for damage or expiration Replace any accessories found to be damaged or that have exceeded their expiration date 4 Check the exterior of the samaritan PAD for cracks or other signs of damage Contact your authorised HeartSine distributor if any damage is found 5 Check that trained responders are aware of the samaritan PADs location and that it is easily accessible for those responders at all times 6 Ensure all trained responders have up to date training for both CPR and AED use For recommended retraining intervals please consult the organisation or body used to provide the training SELF TEST The samaritan PAD includes an automatic self test which is performed on a weekly basis The self test program will run automatically and requires no user interaction Upon completion of self test the samaritan PAD will emit a beep The self test program will test your samaritan PAD and ascertain if its functions are running If the self test should fail then the LED will stop flashing Self test is not able to determine if the battery and defibrillation pads currently inserted in samaritan PAD are within their use by date You must remember to check the expiration date on the Pad
13. Pak regularly er sam300P user manual STATUS INDICATOR The samaritan PAD sam300P includes a status indicator This is an indicator which will flash Green approximately once every five seconds When it is flashing GREEN itis an indication that the samaritan PAD is ready for use If this indicator is not flashing there is a problem with your samaritan PAD If this is the case please refer to the troubleshooting section for further guidance and fault finding advice This is an indicator which will flash green once every five seconds When it is flashing green it is an indication that the samaritan PAD is ready for use Check that the samaritan PAD status indicator can be seen easily Ensure that it is flashing GREEN approximately once every 5 seconds It is not necessary to power up your samaritan PAD to check the status REGULARLY TURNING ON THE DEVICE HeartSine recommend that users do not activate the samaritan PAD on a regular basis to check its functionality Regularly turning on the samaritan PAD is not necessary as the status indicator informs the user if there is a problem with the samaritan PAD Please note Every time the samaritan PAD is turned on it uses power from the battery contained in the Pad Pak Continued regular periodic activation of the samaritan PAD to check functionality may reduce the standby life of your Pad Pak resulting in the need for premature replacement When the
14. ak should not be used beyond the stated expiry date The Pad Pak and Pediatric Pak are both single use items If a Pad Pak or Pediatric Pak are used on a patient they must not be used again PLEASE NOTE HeartSine Technologies or the authorised distributor are not obliged to carry out service repairs 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 indications for use or the instructions provided in this manual The serial number of the apparatus is removed defaced misused or altered The device electrodes or batteries are stored or used operationally outside of environmental specifications Pad Pak packaging is not returned The device has been tested using unapproved methods or inappropriate equipment see maintenance section Any claims made under warranty must be directed via your distributor from whom the device was originally purchased Before carrying out service under warranty HeartSine Technologies require evidence of purchase The product must be used in accordance with the user manual and for the purpose for which it was intended If you have a query please contact support HeartSine com for assistance OPTIONAL DATA MANAGEMENT PACKAGE As an accessory HeartSine offer a Data Management package for the samaritan PAD The package contains both the software and
15. amaritan PAD should assure that it is used in such an environment Emissionstest Compliance Electromagnetic environment guidance RF emissions The samaritan PAD uses RF energy only for its CISPR 11 internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B CISPR 11 Harmonic emissions Not applicable IEC 61000 3 2 Voltage fluctuations flicker Not applicable emissions IEC 61000 3 3 The samaritan PAD is intended for use in the electromagnetic environment specified below The customer or the user of the samaritan PAD should assure that itis used in such an environment Immunity test IEC 60601 Compliance level Electromagnetic environment test level guidance Electrostatic discharge Floors should be wood concrete or ESD 6kV contact 6 kV contact ceramic tile If floors are covered with IEC 61000 4 2 8kV air 8 kV air synthetic material the relative humidity should be a least 30 Power frequency Power frequency magnetic fields 50 60 Hz magnetic should be at levels characteristic of a field typical location in a typical IEC 61000 4 8 commercial or hospital environment sam300P user manual 25 26 Guidance and Manufacturers declaration Electromagnetic Emissions The samaritan PAD is intended for use in the electromagnetic environment specified below The customer or the user of the samar
16. cable which allows users to download and manage recorded incidents from the memory of the samaritan PAD For further information on this optional accessory please contact your HeartSine authorised distributor Data Port Optional Data Management Package q TENS ARDAN my ty Pe y jea fes jas jas Saver EVO Software amp USB Cable www HeartSine com samaritane PAD features samaritan PAD FEATURES Data Port Status Indicator Shock button Safe to touch indicator Speaker Pad Pak cartridge On Off button Do not touch indicator Pads placement indicator sam300P label Action arrows sam300P user manual On Off button Press this button to turn the device on and off Shock button Press this button to deliver a therapeutic shock Status indicator When the indicator is flashing green the samaritan PAD is ready for use Attach PADs indicator The action arrows around this icon will flash to instruct the user that the sam300P pads should be attached to the patient as indicated Safe to touch indicator It is safe to touch the patient when the action arrows around this icon are flashing You may perform CPR or check the patient Do not touch indicator Do not touch the patient when the action arrows around this icon are flashing The samaritan may be analysing the patients heart rhythm or preparing to deliver a shock Action arrows The action arrows arround an icon will flash to indicate
17. cond person after one cycle until professional rescue service arrives www HeartSine com Performing defibrillation STEP 5 Call for medical assistance Remove clothing to expose the patient s chest If the patient has an excessively hairy chest shave the area where the electrodes are about to be applied id Peel pads from liner STEP 2 Lay the samaritan PAD on a flat surface m To safeguard against interference you must operate the PAD at least 2 m 6 feet away from all radio frequency devices and other susceptible equipment Alternatively switch off equipment affected by or causing the electromagnetic interference Peel the electrodes from the liner Apply pads to patient s bare chest as shown in picture gt Press ON OFF Button and open the GREEN Tab of the soft carry case lt The samaritan PAD is activated and you hear the audio prompts and apply them to the bare chest as illustrated on the electrodes Adult patient or Child patient d Press pads firmly to patient s bare skin CALL for medical assistance Remove clothing from patients i Place the electrodes on the patients chest as indicated below chest to expose bare skin Sternum and Apex electrode pads are clearly identified on the respective electrodes Pull green tab to remove pads Press the electrodes firmly to the patient s bare chest to ensure tact is made Grip the SECOND GREEN Tab of Pad Pak and PULL
18. e experiencing symptoms of a heart attack pain pressure shortness of breath squeezing feeling in chest or elsewhere in the body seek emergency medical attention immediately HEART RHYTHM The normal electrical rhythm by which the heart muscle contracts to create blood flow around the body is known as Normal Sinus Rhythm NSR Ventricular Fibrillation VF caused by chaotic electrical signals in the heart is often the cause of SCA but an electrical shock can be administered to re establish normal sinus rhythm This treatment is called defibrillation The samaritan PAD is a device designed to automatically detect Ventricular Fibrillation VF and perform defibrillation on victims of sudden cardiac arrest DETECTING FIBRILLATION The electrical rhythm by which the heart muscle contracts can be detected and used for medical diagnosis and the resulting reading is called an Electrocardiogram ECG The samaritan PAD has been designed to analyze a patients ECG in order to detect Ventricular Fibrillation VF in the heart If Ventricular Fibrillation VF is detected the samaritan PAD will deliver a carefully engineered electrical shock designed to stop the chaotic electrical activity experienced within the heart muscle during SCA This may allow the victim s heart to return to a normal sinus rhythm TRAINING SCA is a condition requiring immediate emergency medical intervention This intervention due to the nature of the condition can be
19. e or cause fire or shock hazard The samaritan PAD contains no user serviceable parts It is not safe for users to attempt to open it or any of its accessories Opening the device will nullify all warranties www HeartSine com Physical Size Weight Defibrillator Waveform Energy Adult Pediatric Charging Time New Battery After 6 discharges Analysis amp Discharge Time New battery After 6 discharges Control Impedance range Patient analysis system Method Sensitivity Sensitivity Display Visual Prompts Audible prompts Indicators Event documentation Type Memory capacity Review capabilities Languages sam300P user manual Technical Data With Pad Pak Battery inserted 8 0x7 25x1 9in 20x18 4x4 8cm 1 1kg 2 4 Ibs SCOPE Self Compensating Output Pulse Envelope Biphasic escalating waveform Optimized biphasic waveform compensates energy slope and envelope for patient impedance Pre configured factory settings for escalating energy are Version AHA ERC 2005 1 Shock 150J 2 Shock 150J 3 Shock 200J 1 Shock 50J 2 Shock 50J 3 Shock 50J Typically 150J in lt 8 sec 200J in lt 12 sec Typically 150J in lt 8 sec 200J in lt 12 sec Maximum time from first analysis period to readiness for discharge 200J in lt 20 sec 200J in lt 20 sec On Off and Shock 200 2300 for details read clinical information section Evaluates patient s ECG signa
20. ed dealer 6 Install a new Pad Pak Before installing the new Pad Pak check that its expiration date has not been exceeded Refer to the Pad Pak installation section for full instructions 7 After installation of the new Pad Pak Check the Status Indicator If the status indicator is not flashing GREEN refer to the troubleshooting section of this manual If the problem persists contact HeartSine Technologies or your local approved distributor for technical support 8 Turn on the PAD and verify that the PAD operates in the correct manner i e audible prompt Call for medical assistance can be heard Turn off the PAD 9 Contacting HeartSine Technologies after use At HeartSine we like to hear from our customers whenever they have any occasion to use any of our products even if therapy is not delivered as part of the incident This information is vital to the continued development and constant improvement we strive for in the treatment of sudden cardiac arrest 18 DISPOSAL INSTRUCTIONS samaritan PAD The samaritan PAD is a re useable device If maintained in accordance with the instruction in this manual it has a warranty period of seven years from the date of manufacture The year of manufacture of the device is indicated by the first two digits of the serial number Disposal If you wish to dispose the samaritan PAD unit it should be disposed of at an appropriate recycling facility according to national
21. edance measurement is a check that is performed to check the integrity of PAD patient contact samaritan PAD SAM300P The PAD is a semi automatic device used for the delivery of external defibrillation therapy to resuscitate victims of SCA who are unresponsive are not breathing or without life signs Saver EVO Software Saver is software that can be used in conjunction with the PAD and a USB cable It can retrieve and view information about therapy delivered using the samaritan PAD Also Saver software can be used to configure the PAD SCOPE SCOPE stands for Self Compensating Output Pulse Envelope Waveform This is the biphasic technology developed by HeartSine that is incorporated into the samaritan PAD Sinus Rhythm Sinus Rhythm is the normal electrical rhythm which causes the heart muscle to contract to create blood flow around the body Self Test A self test is an automatic test that is used to check that the samaritan PAD is working correctly sam300P user manual Glossary Ventricular Fibrillation Is a life threatening heart rhythm that is treatable with the therapy using the samaritan PAD MORE INFORMATION Acopy ofthis manual is available online at www heartsine com or can be requested on CD USA If you have had any occasion to use your samaritan PAD or if you require any further information on the samaritan PAD its accessories or any other products please contact us ABBREVIATI
22. en inserted correctly status indicator flashes green approximately every 5 seconds 6 Press the On Off button to turn the device on Listen for the appropriate messages to start Press the On Off button again to turn the device off Ensure no warning messages are issued by the device and that the status indicator continues to flash GREEN once every five seconds 7 lf necessary inform relevant safety officer or person responsible for maintenance of the samaritan PAD 8 Update the relevant records to show the date that the replacement Pad Pak was placed into service 9 Dispose of the old Pad Pak CHECK THE samaritan PAD CONTACT PINS When changing the Pad Pak HeartSine recommend that users check the contact pins on the samaritan PAD These pins are spring loaded and will retract when the Pad Pak is inserted The picture shown below shows how the contact pins on the samaritan PAD look when the Pad Pak has been removed To ensure proper operation with your finger press lightly on each of the four pins in turn Each pin will push back into the samaritan PAD Check that each pin springs back after it has been released TESTING THE samaritan PAD The Self Test function of the samaritan PAD will determine if the device is ready for use It is strongly recommended that the samaritan PAD should not be tested using standard ECG simulators which have not been approved by HeartSine Testing the samaritan PAD w
23. evice on and off If no warning messages are heard and the status indicator is flashing GREEN then you may return the samaritan PAD to service Leave the working Pad Pak in the samaritan PAD Contact your authorised distributor or HeartSine Technologies directly with details of the fault If this fails or if for any reason you have suspicions that your PAD is not working correctly contact your authorised distributor or HeartSine Technologies directly for support A The samaritan PAD contains no user serviceable parts It is not safe for users to attempt to open it or any of its accessories Opening the device will nullify all warranties 19 Warnings and Precautions gt gt gt gt gt p gt 20 HeartSine Technologies recommend that users are trained in Cardiopulmonary Resuscitation with Defibrillator use CPR D Check with local government health department for information about any requirements associated with ownership and use of a defibrillator in the region where it is to be used Within the United States of America federal U S law restricts this device to sale by or on the order of a licensed practitioner The samaritan PAD has been designed to work on unconscious non responding patients If the patient is responsive or conscious do not use the samaritan PAD to provide treatment The samaritan PAD has the capability to deliver therapeutic electrical shocks The electrical shock can cause
24. f of HeartSine Technologies 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 Copyright 2008 HeartSine Technologies All rights reserved samaritan is a registered trademark of HeartSine Technologies Saver EVO and SCOPE are trademarks of HeartSine Technologies All other trademarks and registered trademarks are the property of their respective owners www HeartSine com Introduction THE samaritan PAD sam300P The HeartSine samaritan PAD is an Automated External Defibrillator AED used for the fast delivery of defibrillation electric shock therapy to resuscitate victims of Sudden Cardiac Arrest SCA SUDDEN CARDIAC ARREST SCA Sudden cardiac arrest is a condition in which the heart suddenly stops pumping effectively due to a malfunction of the heart s electrical system Often victims of SCA have no prior warning signs or symptoms SCA can also occur in people with previously diagnosed heart conditions Survival for an SCA victim depends on immediate cardiopulmonary resuscitation CPR The use of an external defibrillator within the first few minutes of collapse can greatly improve the patients chances of survival Heart attack and SCA are not the same though sometimes a heart attack can lead to a SCA If you ar
25. houlder Send for an AED l Q OPEN THE AIRWAY Watch feel listen P CHECK FOR BREATHING T 2 breaths if necessary PERFORM CPR until an AED is available i k gre OR arrival of emergency physician 2 Breaths 30 Compressions LO Engage other people to help you and alternate CPR If AED AVAILABLE switch ON amp follow instructions If available use an AED ANALYSIS SHOCK DECISION YES NO DELIVER SHOCK Continue CPR until Emergency Medical Services arrive fh T Alternate with second person after one cycle or 2 minutes CONTINUE CPR FOR 2 MINUTES 5 CYCLES sam300P user manual 5 Your samaritane PAD Open the outer box remove the samaritan PAD and all accessories Fill out the Warranty Registration card and send to HeartSine Technologies Read this User Manual Ensure all potential users are suitably trained Place the HeartSine samaritan PAD into service WARRANTY The samaritan PAD is supplied with a seven year warranty from the date of manufacture The year of manufacture of the samaritan PAD is indicated by the first two digits of the serial number s The Pad Pak and Pediatric Pak are single use devices with a stated expiry date The expiry date is stated on the Pad Pak and Pediatric Pak The expiry date is given beside the symbol shown below The Pad Pak and Pediatric Pak has a warranty for use up until the date stated The Pad Pak and Pediatric P
26. itan PAD should assure that it is used in such an environment Immunity test IEC 60601 Compliance Electromagnetic environment guidance test level level Radiated RF 10 V m IEC 61000 4 3 80 MHz to 2 5 GHz d 1 24 P 80MHz to 800 MHz a Sap 800 MHz to 2 5 GHz Where P is the maximum output power rating of the trans mitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol gt NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in fhe frequency range 80 MHZ to 2 5 GHz are intended to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas For this reason an additional factor of 10 3 has been incorporated into the formulae used in calaulating the recommended separation distance for transmitters in these frequency ranges b Field strengths from fixed transmitters
27. ith unapproved testing equipment may damage the device Contact HeartSine for details on approved testing equipment and procedure If end users wish to test their samaritan PAD with an ECG simulator or a defibrillator tester only HeartSine approved ECG simulators and or defibrillator testers should be used Contact your authorised distributor or HeartSine directly for details of HeartSine approved simulators www HeartSine com Maintenance STORAGE TEMPERATURE The samaritan PAD is intended to be stored at a temperature of between 10 to 50 C 50 to 122 F The samaritan PAD can be temporarily stored in the range 10 to 10 C 14 to 50 F for up to two days If you believe that the samaritan PAD has been stored below 10 C 50 F it should be returned to an ambient temperature of between 10 to 50 C 50 to122 F for a period of at least 24 hours before the device is considered ready for use Ensure that the location where the samaritan PAD is stored is maintained at a temperature in the range of 10 to 50 C 50 to 122 F Long term storage outside of this temperature range may adversely affect the performance of the device LOW TEMPERATURE USAGE If the samaritan PAD has been kept in accordance with the storage conditions indicated in this manual between 10 to 50 C 50 to 122 F for a period of at least twenty four hours it may be used in responses where the ambient temperature is between 0 to 10 C 32 to 50
28. l quality electrode contact integrity and patient impedance to determine if defibrillation is required Meets ISO 60601 2 4 and AAMI DF80 2003 Visual and audible prompts instructing user in steps to be taken in order to provide safe and appropriate therapeutic intervention Attach PADs Stand Clear Perform CPR Shock now Self Test Pass Ready State Extensive voice prompts guide the user through the operation sequence Low battery voice prompt at least 10 discharges remain audible prompt alerts the user of electrode disconnect status indicator flashes Green if device ready for use Internal memory 45 minutes of ECG full disclosure and event incident recording Custom USB cable directly connected to PC and Saver EVO windows based data review software Contact your HeartSine Technologies authorised dealer 21 Environmental operating limits Operating temperature Standby temperature Temporary transportation temperature Relative Humidity Water Resistance Altitude Shock Vibration EMC Radiated Emissions Electrostatic Discharge RF Immunity Magnetic Field Immunity Aircraft Pad Pak and Pediatric Pak Shelf Life Weight Size Battery type Capacity Shelf Life Pad Pak Adult Electrodes type Placement Active Area Cable Length Shelf Life Pediatric Pak Pediatric Electrodes type Placement Active Area Cable Length Shelf Life 22 Technical Data
29. ll only administer a shock if it is needed A voice prompt will tell you when to press the shock button to administer defibrillation therapy PPP PrP Pr PRR PPE The Pad Pak must be used on patients over 8 years old The Pediatric Pak must be used on patients less than 8 years old Do not delay treatment trying to find out the patients exact age and weight The Pad Pak is a single use item and must be replaced after each use or if pouch that seals defibrillation pads has been broken compromised in any way If damage is suspected the Pad Pak must be replaced immediately HeartSine Technologies recommend that an additional spare Pad Pak is kept with your samaritan PAD Ensure you are familiar with the instructions on how to change a Pad Pak Ensure that the location where the samaritan PAD is stored is maintained at a temperature in the range of 10 to 50 C 50 to 122 F Storage outside of this temperature range may adversely effect the performance of the device Periodic checks of this device must be undertaken to ensure among other things that the samaritan PAD is not damaged in any way The samaritan PAD must only be tested using approved methods and appropriate equipment For details contact HeartSine Do not clean the samaritan PAD with abrasive materials cleaners or solvents Do not immerse any part of the PAD in water or any type of fluid Contact with fluids may seriously damage the devic
30. nce Do not touch the patient while the PAD is analysing or defibrillation therapy is in process Defibrillation energy can cause injury The Pad Pak must be used on patients over 8 years old The Pediatric Pak must be used on patients less than 8 years old ES When performing CPR watch and listen to the PAD The OK to touch indicator will flash The PAD will emit 100 beeps per minute as a guide to CPR 100 is the recommended rate to perform compressions under AHA ERC 2005 guidelines i 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 STEP 10 The PAD will remain in CPR mode for 2 minutes After 2 minutes of l See Warnings and Precautions for complete list of warnings CPR you will hear the following audible prompt and precautions id Stop CPR INCIDENT NOTIFICATION A As a user of an automated external defibrillator it is essential that you inform HeartSine Technologies of any incident where your samaritan PAD is suspected to have caused a death serious injury or illness If you have any suspicions that this is the case you must inform HeartSine Technologies directly or through your authorised distributor The PAD will then return to Step
31. nisations state that the 2000 guidelines continue to offer safe therapy for patients suffering from Sudden Cardiac Arrest SCA MAIN CHANGES IN DEFIBRILLATION THERAPY BETWEEN AHA ERC 2000 TO 2005 Treat Ventricular Fibrillation VF or Pulseless Ventricular Tachycardia VT with a single shock followed by immediate resumption of CPR 2 ventilations and 30 compressions Do not reassess the rhythm or feel for a pulse After 2 min of CPR 5 cycles of 30 2 check the rhythm and give another shock if indicated The recommended initial energy for biphasic defibrillators is 150J 200J Give second and subsequent shocks at 150J or greater The 2000 guidelines recommended up to 3 shocks followed by 1 minute of CPR 15 compressions to 1 ventilation Further details can be found on the AHA and ERC websites 4 www HeartSine com CPR Guidelines 2005 The following is a brief overview of the fundamentals of CPR for lay rescuers as advised by both the American Heart Association AHA and the European Resuscitation Council ERC in their 2005 published Guidelines for CPR and ECC This is intended only as a quick reference for trained CPR providers HeartSine recommend that all potential users of the samaritan PAD are trained by a competent training organisation in both CPR and samaritan PAD use prior to placing of a samaritan PAD into service CALL Emergency Medical gt aid PERSON Se g er Services 911 112 He ress person amp shake on s
32. nts to remember when selecting a storage location for the samaritan PAD Ensure the samaritan PAD can be retrieved easily at any time HeartSine recommend that the location selected should not be locked as finding key holders may delay the provision of therapy The location selected should be clean and dry The location should be maintained at a temperature between 10 C and 50 C 50 F to 122 F Where possible the samaritan PAD should be stored along with other appropriate CPR accessories such as CPR mask razor scissors etc Ensure that the samaritan PAD status indicator can be seen Make all necessary arrangements to ensure that the device is accessible at all times Inform any possible users of the location of the samaritan PAD HeartSine recommend that an additional spare Pad Pak is kept with your samaritan PAD A spare Pad Pak can be stored in the back section of the samaritan PAD Soft Carry Case Contact HeartSine or an authorised distributor to order spare or replacement Pad Pak s www HeartSine com Maintenance MAINTENANCE HeartSine recommends users perform regular maintenance checks A suggested maintenance check would be 1 Check the Status Indicator If the Status Indicator is not flashing a problem has been detected Refer to the troubleshooting section of this manual 2 x Use Check the expiration date of the Pad Pak currently on BiLA inserted into the samaritan PAD If the
33. or Defibrillation electrodes Anterior Posterior or Anterior Lateral 100cm 1m 3 5 ft Check expiration date typically 3 2 years from manufacture www HeartSine com SCOPE Biphasic Waveform 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 150 J 150 J amp 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 ms for all patient impedances The specific SCOPE waveform characteristics for a 150 J pulse are listed below Pad Pak adult waveform specification Waveform Voltages Volts Waveform Duration ms 3 Duration msec Energy Joules Tilt T1 8 8 sam300P user manual 23 24 ECG Arrythmia Analysis Algorithm The samaritan PAD uses the HeartSine samaritan ECG Arrhythmia Analysis Algorithm This Algorithm will evaluate the patients ECG to ascertain if a therapeutic shock is appropriate If a shock is required the sama
34. p E agent nee sam300P user manual Performing defibrillation STEP 6 When the electrode pads are attached correctly to the patient you will hear the audio prompts ng Assessing heart rhythm id Do not touch the patient K Stand clear of patient The do not touch indicator left on the samaritan PAD will be illuminated Follow audio guidance Do not touch patient or allow any others to touch the patient while the PAD is analyzing After completion of analysis the PAD will advise you of treatment recommended Care must be taken to keep the patient still A moving patient can lead to incorrect delayed or less effective diagnosis and therapy Touching the patient during the analysis phase of treatment can cause interference with the diagnostic process Avoid contact with the patient while analysis is being carried out The device will instruct you when it is safe to touch the patient Placement of the pads is critical Strict observance of pad positioning instructions as indicated on the labeling and in training is essential Failure in pad adhesion may hinder effectiveness of therapy or cause excessive skin burns to the patient if a therapeutic shock is applied 16 STEP 7 If the patient requires a therapeutic shock the PAD will start to charge In such a scenario you will hear the following prompts if Shock advised ig Stand clear of patient The samaritan PAD delivers electrical shocks which can cau
35. ritan PAD will charge and advise the user to press the shock button If no shock is advised the device will pause to allow the user to deliver CPR The HeartSine samaritan ECG Arrhythmia Analysis Algorithm Performance has been extensively evaluated by using several Databases of real life ECG traces included in this are 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 below Perfomance Performance 90 One Sided Lower ELSES ECG Test Sample Size Specifications Confidence Limit Shockable Rhythm Ventricular Fibrillation VF and Sensitivity gt 90 93 48 90 58 h A eg A 1902 Specificity gt 95 100 aer 46711 Specificity gt 95 99 11 95 04 No error to measure a Association for the Advancement of Medical Instrumentation DF 80 2003 Standard for Medical electrical equipment part 2 4 particular requirements for the safety of cardiac defibrillators including automated external defibillators www HeartSine com Guidance and Manufacturers declaration Electromagnetic Emissions The samaritan PAD is intended for use in the electromagnetic environment specified below The customer or the user of the s
36. sage during an emergency response seek an alternative defibrillator immediately sam300P user manual Troubleshooting TROUBLE SHOOTING The following is a brief set of instructions of what to do if you suspect a fault on the samaritan PAD or if the samaritan PAD gives an indication that there may be a fault see fault identification section 1 Check the expiry date of the Pad Pak battery If the expiry date has been exceeded change the Pad Pak immediately For replacement and spare Pad Pak s contact your authorised distributor 2 Ensure that the Pad Pak has been correctly installed Press the Pad Pak firmly into place Turn the device on and let the first audible message play Turn the device off If the samaritan PAD plays no warning messages and the status indicator is flashing green then the samaritan PAD can be returned to service 3 Turn the samaritan PAD on Listen for the appropriate voice prompts Turn the samaritan PAD off Ensure no warning messages are played Check that the status indicator is flashing GREEN If there have been no warning messages and the status indicator is flashing GREEN you may return the samaritan PAD to service 4 Check for any signs of physical damage such as cracks in plastic If any are found remove the samaritan PAD from service and contact HeartSine Technologies or your authorised distributor for further advice 5 Change the Pad Pak Again try turning the d
37. samaritan PAD is switched on the event recording facility is activated Switching on repeatedly will deplete the memory and could lead to insufficient memory to record a defibrillation event The memory can be erased from the samaritan PAD using Saver EVO software Maintenance WHEN TO REPLACE THE PAD PAK The battery lifetime in use can be up to 6 hours monitoring or 30 shocks or a combination of both A Pad Pak in the stand by mode inserted into the samaritan PAD has a shelf life indicated by the expiration date typically 3 5 years from manufacture Replacement of the battery and defibrillation pack must be carried out if gt the expiry date of the Pad Pak has been exceeded When the Pad Pak has been used it is a single use item it must be replaced with a new Pad Pak gt cartridge If the status indicator on the samaritan PAD is not flashing you may need to replace the Pad Pak For diagnosis of the reason for the status indicator not flashing please refer to the troubleshooting section of this manual HOW TO REPLACE A PAD PAK 1 Take the replacement Pad Pak from its protective bag 2 Remove the old Pad Pak which is to be replaced 3 Follow the instruction for Pad Pak installation which can be found on the page titled Preparing your samaritan PAD for use 4 Push the Pad Pak firmly to ensure it is fully inserted 5 Check status indicator If the Pad Pak has be
38. se serious harm to operators and bystanders Caution must be taken to ensure no one is in contact with the patient when a shock is delivered STEP 8 When the PAD has charged to the required level you will hear the audio prompt id Press Shock button now The shock button will be flashing Ensure no one is touching the patient When you are certain that no one is touching the patient press the shock button to deliver the therapy The samaritan PAD will only administer a shock if it is needed A voice prompt will tell you when to press the shock button to administer defibrillation therapy www HeartSine com Performing defibrillation STEP 9 When the shock has been delivered or ECG analysis has stopped you will hear the audio prompts USER AND BYSTANDER SAFETY As long as the defibrillator is used according to the directions and no one is in contact with the patient when the Shock button is pressed there is no risk of harm to the rescuer or bystanders The samaritan PAD cannot deliver a shock unless the electrodes are applied to someone who exhibits the signs of suffering from cardiac arrest and whose heart is in need of a shock It is safe to touch the patient og Begin CPR Use the metronome sound from the PAD for compression rate the unit emits a tone corresponding to 100 beats per minute to current AHA ERC guidelines Note too that the OK TO TOUCH Icon flashes at the same rate for additional guida
39. serious harm to either operators or bystanders Caution must be taken to ensure that neither the operators nor bystanders touch the patient when a shock is to be delivered To safeguard against interference you must operate the samaritan PAD 2 meters 6 feet away from all radio frequency devices and other susceptible equipment Alternatively switch off equipment affected by or causing electromagnetic interference Touching the patient during the analysis phase of treatment can cause interference with the diagnostic process Avoid contact with the patient while analysis is being carried out The device will instruct you when it is safe to touch the patient 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 Proper placement of the samaritan PAD pads is critical Strict observance 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 The samaritan PAD wi
40. such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the samaritan PAD is used exceeds the applicable RF compliance level above the samaritan PAD should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the samaritan PAD c Over the frequency range 150 kHz to 80 MHz field strengths should be lessthan 71 V m www HeartSine com Pad Pak Pediatric Pak The Pad Pak Pediatric Pak is a tray that fits into the samaritan PAD This pack contains the defibrillation electrodes and the battery that supplies power to the samaritan PAD Pull the green tab 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 Pads Defibrillation pads are the electrodes 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 electronic equipment Impedance Measurement Imp
41. tims of SCA who are over eight years old or weigh more than 25kg 55lb The Pediatric Pak child is intended for use on suspected victims of SCA who are over one year old and less than eight years old weighing less than 25kg 55lb The Pediatric Pak with electrodes opened is pictured below The Pad Pak adult and Pediatric Pak child can be quickly differentiated by both colour and shape Please familiarize yourself with the alternative battery and electrode cartridges so that you can select the appropriate version in an emergency A Ensure you are familiar with the instructions on how to change a Pad Pak When inserted into the samaritan PAD SAM300P the Pediatric Pak will protrude from the bottom of the samaritan PAD as shown above 13 14 1 GENERAL Remove patient from a risk area Be aware of your own safety Switch on and follow instructions CPR with defibrillation CPR D fundamentals Perform CPR until a PAD is available PERSON NOT RESPONSIVE NO SIGNS OF LIFE Check breathing open the airway AS GS os PES gt Open PAD remove electrodes peel electrodes from liner Apply electrodes to bare chest as shown in the picture If necessary shave part of chest where electrodes are placed K Either press SHOCK 7 d button or FIX GE oui R Ny perform CPR A for 2 minutes or 5 cycles N Alternate with se
42. uration AHA ERC 2005 guidelines HeartSine Technologies provides you with a fully configured samaritan PAD system to allow you to comply with your chosen SCA treatment protocol Our current device is configured to be compliant l with the 2005 version of the American Heart Association The samantant ely can AHA European Resuscitation Council ERC guidelines on Cardiopulmonary Resuscitation CPR and Emergency Cardiovascular Care ECC You should have been trained in the appropriate version of the AHA ERC guidelines and the use of your device configuration Contact HeartSine or your authorised HeartSine distributor for further information CPR GUIDELINES 2005 VERSUS 2000 In December 2005 both the American Heart Association AHA and the European Resuscitation Council ERC in collaboration with the International Liaison Committee on Resuscitation ILCOR released new guidelines for Cardiopulmonary Resuscitation CPR and Emergency Cardiovascular Care ECC These 2005 guidelines superseded the previous guidelines released in 2000 and contained several changes to the recommended procedures for both CPR and samaritan sam300P label be identifed as it will have the label to the left attached It will be located on the front of the device as shown above automated external defibrillation While the AHA ERC 2005 guidelines are based on the latest research and represent what is believed to be best practice by both the AHA and ERC both orga
43. viding therapy to either adult or pediatric child victims of sudden cardiac arrest Patients who are less than eight years old and weight less than 25 kilograms 55 pounds should be treated as a pediatric patients For use on pediatric patients remove the Adult Pad Pak and insert a Pediatric Pak into the samaritan PAD Full pediatric user instructions are provided with the Pediatric Pak HeartSine Technologies recommend a Pediatric Pak is kept with the samaritan PAD when the device is deployed in locations where children under the age of eight may frequent If the patient is more than 25kilograms 55pounds in weight they should be treated as an adult patient For adult patients the adult Pad Pak should be used in the samaritan Pad A Do not delay treatment trying to find out the patients exact age and weight If a Pediatric Pak is not available and an alternative defibrillator with pediatric capabilities can not readily be found the American Heart Association and European resuscitation guidelines suggest to continue to defibrillate using an adult system HeartSine recommend that the samaritan PAD is kept with a Pad Pak adult inserted in preparation for use on adult patients sam300P user manual Adult or Pediatric child patient PAD PAK OR PEDIATRIC PAK HeartSine Technologies have developed two versions of the Pad Pak The standard Pad Pak is intended to be used with suspected vic
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