User Manual - AEDUniverse.com
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1. 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 SAM 300P is assessing the patients heart rhythm or while defibrillation shock is being applied wy w w V www heartsine com Adult Or Pediatric Child Patient Adult Or Pediatric Child Patient The SAM 300P is capable of providing therapy to either adult or pediatric child victims of SCA Patients who are less than eight years old and weigh 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 SAM 300P Full pediatric user instructions are provided with the Pediatric Pak A HeartSine Technologies recommend a Pediatric Pak is kept with the SAM 300P 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 SAM 300P A 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 su2. Be aware of your own safety to help you Get PAD 5 Switch on and 6 Remove Clothes 7 Open Pad Pak remove electrodes follow instructions peel electrodes from liner Apply electrodes to bare chest as shown below If necessary shave chest at electrodes site Dry Skin 8 Follow Instructions EITHER 9 Press OR 10 Perform CPR for shock button 2 minutes or 5 cycles Alternate with second person after one cycle until professional rescue service arrives www heartsine com Performing Defibrillation Step 1 Call for medical assistance Step 5 Remove clothing to expose the patient s chest If the patient Step 2 Lay the SAM 300P on a flat surface has an excessively hairy chest shave the area where the electrodes are about to be applied A To safeguard against interference you must operate the SAM 300P at least 2m 6 feet away K Peel pads from liner from all radio frequency devices and other susceptible equipment Alternatively switch off equipment affected by or causing the electromagnetic interference Step 3 Apply pads to patient s bare chest as shown in picture Press ON OFF Button and open the green tab of the soft carry case Listen for the audio prompts Adult patient or Child patient Call for medical assistance Press pads firmly to patient s bare skin Remove clothing from patients chest to expose bare skin Place the electrodes on the patients chest as indicated below Sternum and Apex
3. If your SAM 300P is stored in the soft carry case it is not necessary to remove it from the case to operate it Pull green tab to expose electrodes package Cleaning The samaritan PAD To clean the SAM 300P wipe the device with a soft cloth that has been dampened by one of the following gt Soapy water Isopropyl alcohol 70 solution Do not immerse any part of the SAM 300P in water or any type of fluid Contact with fluids may seriously damage the device cause fire or shock hazard Do not clean the SAM 300P with abrasive materials cleaners or solvents gt A A When To Use 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 gt Not breathing normally 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 SAM 300P has been designed to work on unconscious non responding patients If the patient is responsive or conscious do not use the SAM 300P to provide treatment Pre Defibrillation Actions Prior to using a SAM 300P it is advised to perform the following checks and actions in order to prepare the patient Remove clothing to expose bare chest
4. These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the 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 calculating the recommended separation distance for transmitters in these frequency ranges Field strengths from fixed transmitters 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 SAM 300P is used exceeds the applicable RF compliance level above the SAM 300P should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the SAM 300P 3 Over the frequency range 150 kHz to 80 MHz field strengths should be less than V1 V m www heartsine com Glossary Pad Pak Pediatric Pak The Pad Pak Pediatr
5. an accessory HeartSine offer a Data Management package for the SAM 300P The package contains both the software and cable which allows users to download and manage recorded incidents from the memory of the SAM 300P For further information on this optional accessory please contact your HeartSine authorized distributor Optional Data Management Package Saver EVO Software amp USB Cable USB Port www heartsine com samaritan PAD 300P Features gt X TI r 0 O U gt Data Port Status Indicator Shock Button Safe To Touch Indicator Speaker Pad Pak Cartridge On Off Button Do Not Touch Indicator Pads Placement Indicator SAM 300P label Action Arrows SAM 300P 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 SAM 300P is ready for use Attach PADs indicator The action arrows around this icon will flash to instruct the user that the SAM 300P 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 SAM 300P may be analysing the patients heart rhythm or preparing to deliver a shock Ac
6. electrode pads are clearly identified on the respective electrodes 9 AA V K Pull green tab to remove pads gt Press the electrodes firmly to the patient s bare chest to Grip the second green tab of Pad Pak and PULL ensure proper contact is made SAM 300P User Manual Performing Defribrillation Step 6 When the electrode pads are attached correctly to the patient you will hear the audio prompts K Assessing heart rhythm lt Do not touch the patient Stand clear of patient The do not touch indicator above on the samaritan PAD will be illuminated e Follow audio guidance Do not touch patient or allow others to touch patient while the SAM 300P is analyzing After completion of analysis the SAM 300P will advise you of treatment recommended Care must be taken to keep 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 which may cause increased analysis time Avoid contact with the patient while analysis is being carried out The device will instruct you when it is safe to touch the patient A 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 sk
7. indicator can be seen easily Ensure that it is flashing green approximately once every 5 seconds It is not necessary to power up your SAM 300P to check the status The SAM 300P performs a self test routine at midnight GMT on Sunday During this self test period the status light will blink red The status light shall return to green on successful completion of the self test routine Regularly Turning On Device HeartSine recommend that users do not activate the SAM 300P on a regular basis to check its functionality Regularly turning it on is not necessary as the status indicator informs the user if there is a problem with the SAM 300P Please note Every time the SAM 300P is turned on it uses power from the battery contained in the Pad Pak Continued regular periodic activation of the device to check functionality may reduce the standby life of your Pad Pak resulting in the need for premature replacement When the SAM 300P 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 SAM 300P using Saver EVO software Maintenance Replacing The Pad Pak The battery lifetime in use can be up to 6 hours monitoring 30 shocks or a combination of both A Pad Pak in the stand by mode inserted into the SAM 300P has a shelf life indicated by the expiration date typically 3 5 ye
8. service i 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 SAM 300P 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 SAM 300P look when the Pad Pak has been removed xuyan Se To ensure proper operation using your finger press lightly on each of the four pins in turn Each pin will push back into the SAM 300P Check that each pin springs back after it has been released Testing The samaritan PAD The Self Test function of the SAM 300P will determine if the device is ready for use The SAM 300P should not be tested using standard ECG simulators A Testing the SAM 300P with unapproved testing equipment may damage the device and will invalidate your warranty Contact your HeartSine authorized distributor or HeartSine Technologies directly for details on how to get your SAM 300P tested www heartsine com Maintenance Operating Standby Conditions The SAM 300P is intended to be stored at a temperature of between 0 C to 50 C 32 F to 122 F HeartSine recommend that if possible the device is stored at room temperature as this will ensure the peak performance for both the SAM 300P and the Pad Pak A Ensure that the location where the SAM 300P is stored is maintained at a temperature in the range of 0 C to 50 C 32 F t
9. spare Pad Pak for use and be prepared to change it quickly Warning Device Service Required This warning indicates that the SAM 300P has detected a fault Contact your authorized distributor or HeartSine Technologies directly for further instruction If you hear this message during an emergency response seek an alternative defibrillator immediately SAM 300P User Manual Troubleshooting The following is brief set of instructions of what to do if you suspect a fault on the SAM 300P or if the SAM 300P gives an indication that there may be a fault see fault identification section a 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 Paks contact your authorized distributor or HeartSine Technologies b 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 SAM 300P plays no warning messages and the status indicator is flashing green then the samaritan PAD can be returned to service Turn the SAM 300P on Listen for the appropriate voice prompts Turn the SAM 300P 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 SAM 300P to service d Check for any signs of
10. users perform regular maintenance checks A suggested maintenance check would be a Check the Status Indicator If the Status Indicator is not flashing or is flashing red a problem has been detected Refer to the troubleshooting section of this manual P17 b Check the expiration date of the Pad Pak currently inserted into the SAM 300P If the Pad Pak has exceeded its use by date remove it from the SAM 300P and replace with a new Pad Pak Contact your local authorized HeartSine distributor for replacements C Check supplies accessories and spares for damage or expiration Replace any accessories found to be damaged or that have exceeded their expiration date d Check the exterior of the SAM 300P for cracks or other signs of damage Contact your authorized HeartSine distributor if any damage is found e Check that trained responders are aware of the SAM 300P s location and that it is easily accessible for those responders at all times f 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 SAM 300P includes an automatic self test which is performed on a weekly basis The self test program will run automatically and requires no user interaction The SAM 300P performs a self test routine at midnight GMT on Sunday During this self test period the status light will blink red
11. 300P unit it should be disposed of at an appropriate recycling facility according to national state and local requirements Alternatively return the unit to your local distributor or HeartSine Technologies for disposal Within the European Union Do not dispose of the SAM 300P unit as unsorted municipal waste Collect the SAM 300P 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 distributor 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 SAM 300P unit However special consideration must be given to the battery and defibrillation electrodes contained within the device Alternatively please contact your local distributor to organise the disposal of the Pad Pak Battery The Pad Pak battery must be recycled separately in accordance with your national state and local regulations Please contact your local distributor or HeartSine Technologies to organise disposal Electrodes When disposing of a used Pad Pak the defibrillation electrodes may be contaminated with human bodily tissue fluid or blood Detach the electrodes from the Pad Pak Place the electrodes together The electrod
12. HeartSine samaritan PAD SAM 300P User Manual HeartSine Contents Introduction samaritan PAD Model SAM 300P configuration CPR Guidelines 2005 Your samaritan PAD samaritan PAD 300P Features Preparing Your samaritan PAD For Use Maintenance When To Use The samaritan PAD Adult Or Pediatric Child Patient CPR With Defibrillation CPR D Fundamentals Performing Defibrillation After Using samaritan PAD Troubleshooting Warnings And Precautions Technical Data SCOPE Biphasic Waveform ECG Arrhythmia Analysis Algorithm Guidance And Manufacturers Declaration Glossary 10 11 12 14 16 17 18 19 21 22 23 25 About This Edition The information in this manual applies to the HeartSine Technologies samaritan PAD 300P automatic external defibrillators which have serial numbers where the first two digits are 08 or above Information in this document is subject to change without notice and does not represent a commitment on behalf 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 2009 HeartSine Technologies All rights reserved samaritan is a registered trademark of HeartSine Technologies Saver EVO and SCOPE are trademarks of He
13. Immunity test Compliance level test level guidance Electrostatic discharge C y c ntac Be coitac Floors should be wood concrete or ceramic tile ESD E soer E SON ae If floors are covered with synthetic material the IEC 61000 4 2 E E relative humidity should be a least 30 Power frequency Power frequency magnetic fields should be at 50 60 Hz magnetic field levels characteristic of a typical location in a IEC 61000 4 8 typical commercial or hospital environment SAM 300P User Manual Guidance and Manufacturers declaration Electromagnetic Emissions The SAM 300P is intended for use in the electromagnetic environment specified below The customer or the user of the device 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 d 1 2 VP 80MHz to 800 MHz IEC 61000 4 3 80 MHz d 2 3 VP 800 MHz to 2 5 GHz to 2 5 GHz Where P is the maximum output power rating of the transmitter 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 Co NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2
14. The status light shall return to green on successful completion of the self test routine The self test will take no more than 10 seconds to complete The flashing green LED indicates the availability of the device for immediate use Upon completion of self test the SAM 300P will emit a beep The self test program will test your SAM 300P and ascertain if its functions are running If the self test should fail then the LED will flash red and the device will emit a beep approximately once every 5 seconds Self test is not able to determine if the battery and defibrillation pads currently inserted in SAM 300P are within their use by date Remember to check the expiration date on the device SAM 300P User Manual T The SAM 300P contains no user serviceable parts therefore an annual service is not required Status Indicator The SAM 300P includes a status indicator This is an indicator which will flash green approximately once every five seconds When it is flashing green it is an indication that the SAM 300P is ready for use If this indicator is flashing red or not flashing there is a problem with your SAM 300P 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 approximately once every five seconds When it is flashing green it is an indication that the SAM 300P is ready for use Check that the SAM 300P status
15. aners or solvents The IP56 rating does not cover the immersion of any part of the SAM 300P in water or any type of fluid Contact with fluids may seriously damage the device cause fire or shock hazard The SAM 300P 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 The SAM 300P performs a self test routine at midnight GMT on Sunday During this self test period the status light will blink red The status light shall return to green on successful completion of the self test routine The self test will take no longer than 10 seconds to complete www heartsine com Technical Data Physical Size Weight Defibrillator Waveform Energy Adult Pediatric Charging Time New Battery After 6 discharges Analysis amp Discharge Time New battery After 6 discharges Time to shock following CPR Control Buttons Impedance range Patient analysis system Method Specificity Sensitivity Display Visual Prompts Audible prompts Alarms Event documentation Type Memory capacity Review capabilities SAM 300P User Manual 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 s
16. aration kits or fire extinguishers etc If possible these should be located close to a telephone so that the rescuer can call emergency services and retrieve the SAM 300P without wasting time Some important points to remember when selecting a storage location for the SAM 300P a Ensure the SAM 300P 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 b The location selected should be clean and dry Avoid using locations which may be damp or dusty C The location should be maintained at a temperature between 0 C and 50 C 32 F to 122 F Do not select locations which may expose the defibrillator to extreme temperatures even if this is for small amounts of time d Where possible the SAM 300P should be stored along with other appropriate CPR accessories such as CPR mask razor scissors etc e Ensure that the SAM 300P status indicator can be seen f Make all necessary arrangements to ensure that the device is accessible at all times Inform any possible users of the location of the SAM 300P A er HeartSine recommend that an additional spare Pad Pak is kept with your SAM 300P A spare Pad Pak can be stored in the back section of the SAM 300P Soft Carry Case Contact HeartSine or an authorized distributor to order spare or replacement Pad Paks www heartsine com Maintenance HeartSine recommends
17. ars from manufacture Replacement of the battery and defibrillation pack must be carried out if j 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 cartridge If the status indicator on the SAM 300P is flashing red or not flashing you may need to replace the Pad Pak For diagnosis of the reason for the status indicator flashing red or not flashing please refer to the troubleshooting section of this manual How To Replace A Pad Pak Take the replacement Pad Pak from its protective bag Remove the old Pad Pak which is to be replaced C Follow the instruction for Pad Pak installation which can be found on the page titled Preparing your SAM 300P for use Push the Pad Pak firmly to ensure it is fully inserted e Check status indicator If the Pad Pak has been inserted correctly status indicator flashes green approximately every 5 seconds f 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 approximately once every five seconds g If necessary inform relevant safety officer or person responsible for maintenance of the SAM 300P h Update the relevant records to show the date that the replacement Pad Pak was placed into
18. artSine Technologies All other trademarks and registered trademarks are the property of their respective owners Symbol Definitions kk Note A Warning K Voice Prompt To Do www heartsine com Introduction The SAM 300P The SAM 300P 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 SCA victims depends on immediate cardiopulmonary resuscitation CPR The use of an external defibrillator within the first few minutes of collapse can greatly improve the survival chances of a patient Heart attack and SCA are not the same though sometimes a heart attack can lead to a SCA If you are 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 hea
19. d 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 gt gt PPP Pr PRR B gt The SAM 300P 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 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 SAM 300P Ensure you are familiar with the instructions on how to change a Pad Pak Ensure that the location where the SAM 300P is stored is maintained at a temperature in the range of 0 to 50 C 32 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 SAM 300P is not damaged in any way Testing the SAM 300P with unapproved testing equipment may damage the device and will invalidate your warranty Do not clean the SAM 300P with abrasive materials cle
20. der If potential users of the SAM 300P 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 A HeartSine Technologies recommend that users are trained in Cardiopulmonary Resuscitation with the use of a Defibrillator CPR D A 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 Store this manual with the SAM 300P it will fit into the back section of the soft carry case Ensure all potential users of the SAM 300P have read this manual and are familiar with its operation A Within the United States of America federal U S law restricts this device to sale by or on the order of a licensed practitioner Warranty Registration Under internationally agreed 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 and return it to your authorized distributor or HeartSine Technologies directly Your participation will allow us to contact you in the event of important notifications about the SAM 300P such as any future software updates or field safety corrective actions Please complete t
21. e Limit Shockable Rhythm Ventricular Fibrillation VF and 2453 Sensitivity gt 90 93 48 90 58 Ventricular Tachycardia VT SOTAA A anil AU 1902 Specificity gt 95 100 100 Asystole Non Shockable Rhythm v All other Rhythms 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 defibrillators www heartsine com Guidance And Manufacturers Declaration Electromagnetic Emissions The SAM 300P is intended for use in the electromagnetic environment specified below The customer or the user of the SAM 300P should assure that it is used in such an environment Emissionstest Compliance Electromagnetic environment guidance The SAM 300P uses RF energy only for its internal RF emissions function Therefore its RF emissions are very low CISPR 11 and are not likely to cause any interference in nearby electronic equipment RF emissions Harmonic emissions Notapolicabl IEC 61000 3 2 PP Voltage fluctuations flicker emissions Not applicable IEC 61000 3 3 The SAM 300P is intended for use in the electromagnetic environment specified below The customer or the user of the SAM 300P should assure that it is used in such an environment IEC 60601 Electromagnetic environment
22. es must be disposed of separately as an 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 Troubleshooting Fault Identification If the SAM 300P detects a problem it will indicate to the user that there may be a problem by two ways Status indicator This should flash green approximately once every five seconds If it is flashing red or not flashing at all there may be a problem Refer to troubleshooting section for further advice see maintenance section for details Warning message While turned on the SAM 300P may play audible warning messages to indicate that there may be a problem These messages are rf Warning Memory Full This message indicates that the memory for the event recording facility on the SAM 300P is full The therapeutic capabilities of the device will be 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 SAM 300P until emergency services arrive E 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 SAM 300P until emergency services arrive If available prepare the
23. ettings 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 for first analysis period to readiness for discharge 200J in lt 20 sec 200J in lt 20 sec Typically 8 sec On Off and Shock 200 2300 For details read clinical information section Evaluates patient s ECG signal 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 typically 10 discharges remain if stored and maintained in accordance with HeartSine recommendations audible prompt alerts the user of electrode disconnect status indicator flashes red if self test fail or when service required 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 Technical Data Languages Environmental operat
24. ggest to continue to defibrillate using an adult system HeartSine recommend that the SAM 300P is kept with a Pad Pak adult inserted in preparation for use on adult patients Do not delay treatment trying to find out the patients exact age and weight SAM 300P User Manual Pad Pak or Pediatric Pak Patient HeartSine Technologies have developed two versions of the Pad Pak The standard Pad Pak is intended to be used with suspected victims of SCA who are over eight years old or weigh more than 25kg 551b 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 SAM 300P the Pediatric Pak will protrude from the bottom of the samaritan PAD as shown above CPR With Defibrillation CPR D Fundamentals 1 Safety 2 Not responsive 3 Contact 4 Perform CPR until No sign of life Check emergency a PAD is available breathing open airway services Remove patient from risk area Engage other people
25. he PAD The safe to touch icon will flash The PAD emits 100 beeps per minute as a guide to CPR 100 is the recommended rate to perform compressions under AHA ERC 2005 guidelines Step 10 The SAM 300P will remain in CPR mode for 2 minutes After 2 minutes of CPR you will hear the following audible prompt E Stop CPR The SAM 300P will then return to Step 6 Ensure no one is in contact with the patient and proceed as before Follow the voice prompts until the emergency medical services arrive gt SAM 300P User Manual 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 SAM 300P 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 SAM 300P cannot deliver a shock unless electrodes are applied to someone who exhibits signs of suffering from cardiac arrest and whose heart is in need of a shock Do not touch the patient while the SAM 300P is in the process of delivering defibrillation therapy 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 Do not delay treatment through trying to find out the age and weight of
26. he Warranty Registration card included with the SAM 300P Registration is required to validate the product warranty The information provided will be kept strictly confidential and will not be shared with other organisations samaritan PAD model SAM 300P configuration The SAM 300P Label The SAM 300P can be identified by the label above attached It will be located on the front of the device as shown below AHA ERC 2005 guidelines HeartSine Technologies provides you with a fully configured system to allow you to comply with your chosen SCA treatment protocol Our current device is configured to be compliant with the 2005 version of the American Heart Association 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 authorized 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
27. ial users of the SAM 300P are trained by a competent training organisation in both the use of CPR and SAM 300P prior to placing a SAM 300P into service CALL Emergency Services 999 911 112 etc Send for an AED Person not responsive Address person and shake on shoulder Open the airway check for breathing Address person and shake on shoulder Perform CPR until an AED is available OR arrival of emergency physician Engage other people to help you and alternate CPR If AED is available switch on and follow instructions Watch feel listen 2 Breaths 30 Compressions AHA 30 compressions 2 Breaths ERC Analysis shock decision If available use an AED YES NO DELIVER SHOCK Continue CPR until Emergency Services arrive Alternate with second person after one cycle or 2 minutes Continue CPR for 2 minutes 5 cycles SAM 300P User Manual Your samaritan PAD Unpacking Your SAM 300P a Open the outer box remove the SAM 300P and all the accessories b Fill out the warranty registration card and return to Heartsine Technologies Read this User Manual Ensure all potential users are suitably trained e Place the SAM 300P into service Warranty The SAM 300P is supplied with a seven year warranty from the date of manufacture e7 The Pad Pak and Pediatric Pak has a warranty for use up until the date stated The Pad Pak and Pediatric Pak should not be used beyond the stated e
28. ic 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 Impedance measurement is a check that is performed to check the integrity of PAD patient contact samaritan PAD The samaritan 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 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 SAM 300P User Manual Sinus Rhythm Sinus Rhythm is the normal elect
29. ient is responsive or conscious do not use the SAM 300P to provide treatment The SAM 300P 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 nor bystanders touch the patient when a shock is to be delivered To safeguard against interference you must operate the SAM 300P 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 which may cause increased analysis time 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 SAM 300P is safe to use in conjunction with oxygen mask delivery systems However due to the danger of explosion it is strongly advised that the SAM 300P should not be used in the vicinity of explosive gases This includes flammable anaesthetics or concentrated oxygen Proper placement of the SAM 300P 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 pa
30. in burns to the patient if a therapeutic shock is applied Step 7 If the patient requires a therapeutic shock the SAM 300P will start to charge In such a scenario you will hear the following prompts d Shock advised of A Stand clear of patient The SAM 300P delivers electrical shocks which can cause 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 SAM 300P has charged to the required level you will hear the audio prompt if Press Shock button now Above left is the do not touch the patient icon When you are certain that no one is touching the patient press the shock button above right to deliver the therapy A The SAM 300P 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 ef It is safe to touch the patient K Begin CPR Begin CPR immediately Use the metronome sound from the SAM 300P for compression rate the unit emits a tone corresponding to 100 beats per minute to current AHA ERC guidelines Note too that the safe to touch icon flashes above at the same rate for additional guidance e When performing CPR watch and listen to t
31. ing limits Operating Standby temperature Shipping 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 Size Battery type Capacity Pad Pak Adult Electrodes type Placement Active Area Cable Length Shelf Life Pediatric Pak Pediatric Electrodes type Placement Active Area Cable Length Shelf Life Contact your HeartSine Technologies authorized distributor 0 to 50 C 32 to 122 F 10 to 50 C 14 to 122 F for up to two days If device has been stored below 0 C 32 F it should be returned to an ambient temperature of between 0 to 50 C 32 to 122 F for at least 24 hours before use 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 ISO 9001 GB02 54194 ISO 13485 GB02 54195 EEC 92 43 GB02 54193 Disposable single use combined battery and defibrillation elect
32. nd spares for damage or expiration Replace immediately if any damage or expiration is found Contact your local HeartSine approved distributor f 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 g 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 h Turn on the SAM 300P and verify that the SAM 300P operates in the correct manner i e audible prompt Call for medical assistance can be heard Turn off the SAM 300P i Contact 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 SCA Disposal Instructions SAM 300P The SAM 300P is a reusable 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 of the SAM
33. o 122 F Long term storage outside of this temperature range may adversely affect the performance of the device When using the samaritan PAD in low temperature conditions HeartSine recommends that it is not exposed to the lower temperatures until it is about to be used S Shipping And Transportation Temperature The SAM 300P may be temporarily stored in the range 10 C to 50 C 14 F to 122 F for up to two days If you believe that the SAM 300P has been stored below 0 C 32 F it should be returned to an ambient temperature of between 0 C to 50 C 32 F to 122 F for a period of at least 24 hours before the device is considered ready for use A The SAM 300P is not intended to be used in ambient temperatures below 0 C 32 F or above 50 C 122 F On Board Temperature Sensor The SAM 300P incorporates a temperature sensor When the SAM 300P is turned on it will check the ambient temperature of the device The SAM 300P will detect if it is outside of its intended storage temperature range of 0 C to 50 C 32 F to 122 F by emitting three beeps when turned off SAM 300P User Manual samaritan PAD Soft Carry Case The SAM 300P and Soft Carry Case have been designed to allow the rescuer to use the device without having to open the SAM 300P carry case Back view With clear window for quick start card Front view A clear plastic cover protects the SAM 300P while allowing the rescuer to operate the unit
34. physical damage such as cracks in the plastic If any are found remove the SAM 300P from service and contact HeartSine Technologies or your authorized distributor for further advice e Change the Pad Pak Again try turning the device on and off If no warning messages are heard and the status indicator is flashing green then you may return the SAM 300P to service Leave the working Pad Pak in the SAM 300P Contact your authorized distributor or HeartSine Technologies directly with details of the fault If this fails or if for any reason you have suspicions that your SAM 300P is not working correctly contact your authorized distributor or HeartSine Technologies directly for support A The SAM 300P 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 Warnings And Precautions A A A A A A A A gt 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 SAM 300P has been designed to work on unconscious non responding patients If the pat
35. rical 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 Ventricular Fibrillation Is a life threatening heart rhythm that is treatable with the therapy using the samaritan PAD More Information A copy of this manual is available for download online at www heartsine com or can be requested on CD USA Abbreviations CPR Cardiopulmonary Resuscitation CPR D Cardiopulmonary Resuscitation Defibrillation SCA Sudden Cardiac Arrest VF Ventricular Fibrillation BLS Basic Life Support ACLS Advanced Cardiac Life Support NSR Normal Sinus Rhythm HeartSinee Worldwide Headquarters HeartSine Technologies Inc 121 Friends Lane Suite 400 Newtown PA 18940 Tel 1 215 860 8100 Fax 1 215 860 8192 Manufactured by HeartSine Technologies Ltd Canberra House 203 Airport Road West Belfast BT3 9ED Northern Ireland Tel 44 0 28 9093 9400 www heartsine com support heartsine com Authorised Distributor Ce 0120 H017 001 400 8 English March 2009
36. rode cartridge Check expiration date typically 3 years from manufacture 0 44 Ibs 0 2kg Lithium Manganese Dioxide LiMnO2 18V 0 8 Amp Hrs gt 30 shocks at 200J or 6 hours of continuous monitoring 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 100cm2 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 55lb Available as an optional accessory Single use pre attached combined ECG sensor Defibrillation electrodes Anterior Posterior or Anterior Lateral 100cm2 1m 3 5 ft Check expiration date typically 32 years from manufacture www heartsine com SCOPE Biphasic Waveform The HeartSine SAM 300P 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 pha
37. rt is often the cause of SCA but an electrical shock can be administered to re establish NSR This treatment is called defibrillation The samaritan PAD is a device designed to automatically detect 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 SAM 300P has been designed to analyze a patients ECG in order to detect VF in the heart If VF is detected the SAM 300P 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 NSR SAM 300P User Manual Training SCA is a condition requiring immediate emergency medical intervention This intervention due to the nature of the condition can be performed prior to seeking the advice of a physician In order to properly diagnose this condition HeartSine recommends that all potential users of the SAM 300P 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 SAM 300P 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 provi
38. se 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 150J pulse are listed below V 150 2 00 25 150 1660 1 Pad Pak adult waveform specification Energy Waveform Voltages Volts Pad Pak adult waveform specification 1 SAM 300P User Manual ECG Arrythmia Analysis Algorithm The SAM 300P 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 samaritan 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 SAM 300P 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 SAM 300P ECG Arrhythmia Analysis Algorithm Sensitivity and Specificity meet the AAMI DF80a 2003 requirements and AHA recommendations The HeartSine SAM 300P ECG Arrhythmia Analysis Algorithm performance is summarized in the table below Rhythm Class ECG Test Performance Performance 90 One Sided Lower y Sample Size Specifications Results Confidenc
39. the patient It has been determined that the SAM 300P is safe to use in conjunction with oxygen mask delivery systems However due to the danger of explosion it is strongly advised that the SAM 300P should not be used in the vicinity of explosive gases This includes flammable anaesthetics or concentrated oxygen See Warnings and Precautions for complete list of warnings and precautions Incident Notification As a user of an AED it is essential that you inform HeartSine Technologies of any incident where your SAM 300P 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 authorized distributor After Using samaritan PAD Post Use Checklist After using your SAM 300P HeartSine Technologies recommend you perform the following actions a For data download please contact your authorized distributor or HeartSine Technologies b Remove the used Pad Pak from your SAM 300P and dispose of in a suitable manner For recommended disposal methods please refer to disposal instructions section C Check the exterior of the SAM 300P for cracks or other signs of damage Contact your distributor or HeartSine Technologies immediately if any damage is found d Check the exterior of the SAM 300P for dirt or contamination If needed clean device with approved cleaning products e Check supplies accessories a
40. tion arrows The action arrows around an icon will flash to indicate the actions that the user should be performing Preparing Your samaritan 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 Installation 1 Remove the Pad Pak from its packaging and place the SAM 300P and the Pad Pak ona flat surface Z 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 protective packaging until the time of emergency use when they are applied to a patient er Installation 2 Test SAM 300P Push the ON Button Ensure you can hear the voice prompts Adult patient or Child patient Call for medical assistance Switch Off by pressing OFF Button Installation 3 Place the SAM 300P into its Soft Carry Case For alternative transport cases ask HeartSine or your distributor Installation 4 SAM 300P Storage Put into a wall case or safe visible location Wall cases differ in some countries Contact HeartSine or your authorized distributor for more information The SAM 300P should be kept in a convenient central location Ideally keep it alongside other emergency equipment such as first aid CPR prep
41. to the recommended procedures for both CPR and 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 organisations state that the 2000 guidelines continue to offer safe therapy for patients suffering from Sudden Cardiac Arrest SCA Main Changes In Defribrillation 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 Breaths and 30 compressions AHA or 30 compressions and 2 Breaths ERC 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 web sites www heartsine com CPR Guidleines 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 potent
42. xpiry date The expiry date is given beside the symbol shown below The year of manufacture of the device is indicated by the first two digits of the serial number The Pad Pak and Pediatric Pak are both single use items If a Pad Pak or a Pediatric Pak are used on a patient they must not be used again Warranty Exclusion HeartSine Technologies or the authorized distributor are not obliged to carry out service repairs under warranty if a 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 d 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 meh Pad Pak or Pediatric Pak packaging is not returned g 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
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