H017-019-126-2 UL 300P User Manual UK English
Contents
1. If the measured field strength in the location where the HeartSine Samaritan PAD SAM 300P is used exceeds the applicable RF compliance level see above the HeartSine Samaritan PAD SAM 300P should be observed to verify that it is operating normally If abnormal operation is observed additional measures may be necessary such as re orienting or relocating the HeartSine Samaritan PAD SAM 300P c Over the frequency range 150 kHz to 80 MHz field strength should be less than V1 V m 33 Appendix A Voice prompts Adult Patient Child Patient If a shock is not required Call for Medical Assistance No shock advised Remove Clothing from Patient s Chest Begin CPR to Expose Bare Skin It Is Safe to Touch the Patient Pull Green Tab to Remove Pads Place overlapping hands on Peel Pads from Liner centre of chest Apply Pads to Patient s Bare Chest as Press down in time with the Shown in Picture metronome Press Pads Firmly to Patient s Remain calm Bare Skin Assessing Heart Rhythm Do Not Touch the Patient If a shock is required Stand Clear of Patient Shock Advised Stand Clear of Patient Press the Orange Shock Button Now Shock Delivered Begin CPR It Is Safe to Touch the Patient Place overlapping hands on centre of chest Press down in time with the metronome Remain calm 352. Shock 200 J Paediatric 1 Shock 50 J 2 Shock 50 J 3 Shock 50 J Internal memory 90 minutes of ECG full disclosure and event incident recording Custom USB cable directly connected to a PC and Saver EVO Windows based data review software 25 Technical Data Electromagnetic compatibility EMC EN 60601 1 2 Radiated Emissions EN55011 1999 A2 Electrostatic Discharge EN61000 4 2 8 kV RF Immunity EN61000 4 3 80 MHz 2 5 GHz 10 V m Magnetic Field Immunity _EN61000 4 8 3 A m Aircraft RTCA DO 160D Section 21 Category M RTCA DO 227 TSO C142a HeartSine Quality Management System ISO 9001 GB02 54194 ISO 13485 GB02 54195 EEC 92 43 GB02 54193 26 SCOPE Biphasic Waveform The SAM 300P delivers a Self Compensating Output Pulse Envelope SCOPE biphasic waveform This waveform automatically optimises 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 optimised impedance compensated biphasic truncated exponential waveform that incorporates an escalating energy protocol of 150 joules 150 joules and 200 joules 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
3. suspect that the Pad Pak is damaged you must replace it immediately t Notice Susceptibility to electromagnetic interference To safeguard against interference you must operate the SAM 300P at least 2 m 6 feet away from all radio frequency devices and other susceptible equipment Alternatively switch off the equipment affected by or causing electromagnetic interference Temperature range for operation The SAM 300P with its battery pads and electrodes is designed to operate in the temperature range of 0 C to 50 C Use of the device outside this range may cause malfunction Environmental protection 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 or cause fire or a shock hazard Prolonging standby life Do not turn the device on unnecessarily as this may reduce the standby life of the device Standby storage outside the range of 0 C to 50 C may decrease the shelf life of the device Do not test on simulators and manikins Our devices cannot be tested using industry standard simulators and manikins Standard simulators have a constant r r spacing and do not produce the variability displayed in the normal human heart Our algorithm uses heart rate variability as one of its criteria for measuring ventricular fibrillation VF Consequently we do not recommend the use of normal simulators to
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5. Pak Before installing check the Pad Pak expiry date see Preparation on page 12 After installation check the status indicator is blinking green Service and Maintenance HeartSine recommends users perform regular maintenance checks A suggested maintenance check would be Weekly 1 Check the status indicator If the green status indicator is not flashing approximately every 5 seconds a problem has been detected See Troubleshooting on page 21 The SAM 300P performs a self test routine at midnight GMT on Sunday During this self test period the status light blinks red but returns to green on successful completion of the self test routine The self test takes no more than 10 seconds to complete If the status indicator continues to flash red the SAM 300P has a fault see Troubleshooting on page 21 Monthly 2 If the device shows any signs of physical damage contact your authorised distributor or HeartSine Technologies directly 3 Check the expiry date of the SAM 300P Pad Pak see Preparation on page 12 for the location of the date If the date has expired replace with a new Pad Pak or contact your local HeartSine distributor for a replacement 4 If you hear a warning message when you turn on your SAM 300P or if for any reason you have suspicions that your SAM 300P is not working correctly contact your authorised distributor or HeartSine Technologies directly support HeartSine com 18 Trac
6. specific SCOPE waveform characteristics for a 150 joules pulse are listed opposite 1000 T1111 11 234567 Duration msec a all o o Waveform Duration ms A Waveform Resistance Voltages volts ohms V Tilt 1 Adult Pad Pak waveform specification 27 Technical Data Waveform Duration ms Waveform Voltages volts Tilt Resistance Energy ohms joules Paediatric Pad Pak waveform specification 28 Arrhythmia analysis algorithm The SAM 300P uses the HeartSine samaritan ECG arrhythmia analysis algorithm This algorithm will evaluate the patient s ECG to ascertain if a therapeutic shock is appropriate If a shock is required the SAM 300P 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 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 SAM 300P ECG arrhythmia analysis algorithm s sensitivity an specificity meet the AAMI DF80a 2003 requirements and AHA recommendations The SAM 300P ECG arrhythmia analysis algorithm performance is summarised in the table below Rhythm Class S
7. 40 Vim Field strengths from fixed RF transmitters as determined IEC 61000 4 3 to 2 5 GHz 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 C At 80 MHz and 800 MHz the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people See footnotes on next page 32 uidance and manufacturer s declaration electromagnetic immunity a 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 b 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
8. HeartSine samaritan PAD SAM 300P User Manual Contents Contents 2 Service and Maintenance 18 Warnings and Cautions 4 Tracking Requirements 19 Introduction 9 Data Management 20 The HeartSine samaritan PAD SAM 300P 9 Troubleshooting 2 Sudden Cardiac Arrest SCA 9 Status indicator flashing red 21 Ventricular fibrillation 9 Low battery warning 21 Recommended training 10 Memory full warning 21 CPR metronome 10 Audible warnings 21 SAM 300P Overview 11 Device service required 22 Preparation 12 Sources of support 22 Unpacking 12 Warranty exclusion 22 Checks before putting into service 12 Technical Data 23 Guidelines for storage 14 Appendix A 34 Register your SAM 300P 14 Voice prompts 34 Using the SAM 300P 15 When to use 15 Using the SAM 300P 15 After use 16 Symbols used in this manual Warning Risk of death or serious injury A Caution Risk of injury Notice Risk of damage to data or material Further information Symbols used on this device On Off IP56 Ingress protection classified as IP56 according to EN 60529 Ti Consult operating instructions Follow instructions for use Q Single use item Do not re use R S ma IIS MC L h R oii c UL u 3XN6 Defibrillation protected Type BF connection Do not expose to high heat or open flame Do not incinerate Does not contain natural rubber latex Non sterile Recyclable Non rechargeable battery Do not short circuit battery Do not cru
9. cator at a rate compliant with current AHA ERC guidelines This feature is referred to as the CPR metronome Responders should use this as a guide to the rate for performing compressions SAM 300P Overview Attach pads icon Status indicator Data port The action arrows around this When the indicator is icon will flash to instruct you flashing green the SAM to attach the electrode pads to 300P is ready for use the patient as indicated Shock button Press this button to deliver a therapeutic shock Safe to touch icon Itis safe to touch the patient when the action arrows around this icon are flashing Paediatric ready icon Action arrows On Off button Press this button to turn the device on or off Do not touch icon Do not touch the patient when the action arrows around this icon are flashing The SAM 300P may be analysing the patient s heart rhythm or about to charge Green tab Electrode drawer 1 preparing to deliver a shock Speaker Preparation Unpacking Check that the contents include the User Manual soft case Pad Pak guarantee card and Quick Start Guide A Pad Pak is a single use removable battery and electrode pack in one unit It is available in two versions a pink coloured Pad Pak for use with children and a grey coloured Pad Pak for use with adults see the illustration below Adult Pad Pak Paediatric Pad Pak 12 Checks before putting into service Check the
10. e HeartSine Samaritan PAD SAM 300P should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic 6 kV contact Complies Floors should be wood concrete or discharge ESD ceramic tile If floors are covered IEC 61000 4 2 with synthetic material the relative 8 kV air Complies humidity should be at least 30 Power frequency Power frequency magnetic fields 50 60 Hz 3 Alm Complies should be at levels characteristic magnetic field of a typical location in a typical IEC 61000 4 8 commercial or hospital environment Surge 1 kV line s to line s Not applicable IEC 61000 4 5 2 kV line s to earth Not applicable 31 Technical Data Guidance and manufacturer s declaration electromagnetic immunity The HeartSine Samaritan PAD SAM 300P is intended for use in the electromagnetic environment specified below The customer or user of the HeartSine Samaritan PAD SAM 300P should assure that it is used in such an environment IEC 60601 Compliance Immunity test Electromagnetic environment guidance test level level d 1 2 VP 800 Mhz to 800 Mhz d 2 3 VP 800 Mhz 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 10 Vim distance in metres m Radiated RF 80 MHz
11. eartSine Technologies directly 20 Troubleshooting Status indicator flashing red If the status indicator is flashing red or if the device is emitting a beep check the expiry date on your Pad Pak see Preparation on page 12 If the expiry date has not been passed turn on the SAM 300P by pressing on the front panel and listen for the voice prompt call for medical assistance Then turn off by pressing on the front panel If this action does not correct the problem contact your authorised distributor or HeartSine Technologies immediately Low battery warning The first time the device plays the message warning low battery it will still continue to function properly However it may have fewer than 10 shocks left If you hear this message during use continue to use the SAM 300P until the emergency services arrive If available prepare the spare Pad Pak for use and be prepared to swap it quickly Order a new Pad Pak as soon This message does not indicate a fault as possible Memory full warning If the device plays the message warning memory full then the memory can record no further ECG data or events However the device can still analyse and deliver a shock if required If you hear this message contact HeartSine Technologies technical support Audible warnings If the device emits 3 beeps rapidly when turned off it has sensed that the ambient temperature is outside of t
12. ed temperature range The Pad Pak packaging is not returned The device has been tested using unapproved methods or inappropriate equipment see Warnings and Cautions on page 4 Technical Data Physical parameters with Pad Pak installed Size Weight Environmental Operating temperature Standby temperature Transport temperature Relative humidity Enclosure Altitude Shock Vibration 20 x 18 4 x 4 8 cm 8 0 x 7 25 x 1 9 in 1 1 kg 2 4 Ibs 0 to 50 C 32 to 122 F 0 to 50 C 50 to 122 F 10 to 50 C 14 to 122 F for up to two days If the 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 to 4575 metres MIL STD 810F Method 516 5 Procedure 40G s MIL STD 810F Method 514 5 Procedure 1 Category 4 MIL STD 810F Method 514 5 Procedure 1 Category 7 Pad Pak and Pediatric Pad Pak Shelf Life Weight Battery type Check expiration date 0 2 kg 0 44 Ibs Meets ISO 60601 2 4 and AAMI DF80 2003 23 Technical Data Patient analysis system Method Sensitivity Specificity User Interface Visual prompts Audible prompts Languages Controls Evaluates patient s ECG signal quality electrode contact integrity and patient impedance to determine if defibrillation is requi
13. ent health department for information about any requirements associated with ownership and use of a defibrillator in the region where it is to be used Introduction The HeartSine Samaritan PAD SAM 300P The HeartSine Samaritan PAD SAM 300P is a semi automatic external defibrillator designed to quickly deliver a defibrillation shock to victims of Sudden Cardiac Arrest SCA The SAM 300P is designed to operate in accordance with the joint European Resuscitation Council ERC and American Heart Association AHA 2010 guidelines on Cardiopulmonary Resuscitation CPR and Emergency Cardiovascular Care ECC 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 from SCA depends on immediate cardiopulmonary resuscitation CPR The use of an external defibrillator within the first few minutes of collapse can greatly improve patient s chances of survival Heart attack and SCA are not the same though sometimes a heart attack can lead to an SCA If you are experiencing symptoms of a heart attack chest pain pressure shortness of breath tight feeling in the chest or elsewhere in the body seek emergency medical attention immediately Ventricular fibril
14. es for storage Place the SAM 300P in its supplied soft carry case Store the SAM 300P in an unobstructed secure location in a clean dry environment Be sure to store according to specifications see Technical Data on page 23 that you keep a spare Pad Pak with your SAM 300P You can store it in the rear section of the soft carry case Register your SAM 300P Complete the guarantee card and return it to your authorised distributor or HeartSine Technologies directly see Tracking Requirements on page 19 1 Notice HeartSine recommends 14 Using the SAM 300P When to use Using the SAM 300P The HeartSine Samaritan PAD SAM 300P Refer to the separate Quick Start Guide is indicated for use on victims of sudden During use the SAM 300P will give cardiac arrest who are exhibiting the extensive voice prompts to guide the user following signs For full list of voice prompts see Appendix F A on page 34 Unconscious Not breathing i Notice PAD aborts a ready to shock condition once a non No life signs shockable rhythm is detected The SAM 300P has been designed to work on unconscious nonresponsive patients If the patient is responsive or conscious do not use the SAM 300P to provide treatment The SAM 300P is suitable for use on patients of over 25 kg 55 Ibs in weight or equivalent to a child of approximately eight years old or over For use on younger children remove the adult Pad Pak and insta
15. expiry date year month on the rear of the Pad Pak see the illustration below If the expiry date has passed you must replace the Pad Pak Unpack the Pad Pak Retain the packaging in case you need to return the Pad Pak to HeartSine Insert the Pad Pak into the SAM 300P see the illustration below Listen for the click sound and ensure both tabs are fully engaged Zw The SAM 300P will run a self test routine The action arrows will flash during this process On successful completion of the self test routine the green status indicator see SAM 300P Overview on page 11 will blink If so your SAM 300P is fr for use Notice Do NOT pull the green tab on the Pad Pak If you have opened the electrode drawer you must replace your Pad Pak Turn on the SAM 300P by pressing on the front panel To check that the device is operating correctly listen for appropriate voice prompts and make sure that no warning messages are played Notice Only turn the SAM 300P 1 on ONCE If you turn it on and off repeatedly you will exhaust the batteries prematurely and you will need to replace the Pad Pak Turn off the SAM 300P by pressing on the front panel Check the status indicator see SAM 300P Overview on page 11 is flashing green If you have heard no warning messages and the status indicator is flashing green the device is ready for use 13 Preparation Guidelin
16. he specified operating range This beeping could also occur during the weekly self test During use if the status indicator changes from green to red and the device starts to beep there is insufficient battery capacity to deliver a shock The device will continue to analyse the patient s heart rhythm and advise when CPR is needed 21 Troubleshooting Device service required If the device plays the message device service required then it has detected a fault Contact your authorised distributor or HeartSine directly for further instruction Warning If you hear this message during use seek an alternative defibrillator immediately Sources of support If you have completed the troubleshooting steps above and you find the device is still not working correctly contact your authorised distributor or HeartSine Technologies Technical Support at support HeartSine com Warning No modification of this equipment is allowed 22 Warranty exclusion HeartSine or its authorised distributors are not obliged to replace or repair under warranty if one or more of the following conditions apply The device has been opened Unauthorised modifications have been made The device has not been used in accordance with the instructions provided in this manual The serial number has been removed defaced altered or by any other means made unreadable The device has been used or stored outside its indicat
17. hockable rhythm Ventricular fibrillation VF ECG Test Sample Size Performance Specifications Performance Results 90 One Sided Lower Confidence Limit pal 2453 Sensitivity gt 90 93 48 90 58 ventricular tachycardia VT Mon shocKabIg rhythm 1902 Specificity gt 95 100 100 Asystole Non shockable rhythm on shockable rhythm 46711 Specificity gt 95 99 11 95 04 All other rhythms No error to measure 29 Technical Data Guidance and manufacturer s declaration electromagnetic emissions The HeartSine Samaritan PAD SAM 300P is intended for use in the electromagnetic environment specified below The customer or user of the HeartSine Samaritan PAD SAM 300P should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance The HeartSine Samaritan PAD SAM 300P uses RF RF emissions CISPR 11 Group 1 energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B Harmonic emissions Not ih IEC 61000 3 2 applicable Voltage fluctuations flicker emissions IEC 61000 3 3 Mor applicable 30 anufacturer s declaration electromagnetic immunity The HeartSine Samaritan PAD SAM 300P is intended for use in the electromagnetic environment specified below The customer or user of th
18. king Requirements The Medical Devices Regulations require us to track the location of all medical devices sold It is important that you complete the warranty card with your details and return it to your authorised distributor or HeartSine Technologies directly Alternativley please send an email to support heartsine com containing the following information Name Address Device serial number or use our on line registration tool at https secure heartsine com UserRegistration html Your participation will allow us to contact you with any important notifications about the SAM 300P such as any future software updates or field safety corrective actions If there is a change in the information you have provided to us such as a change of address or a change in ownership of your SAM 300P please contact us with the updated information 19 Data Management The HeartSine Saver EVO software 2 Connect the USB cable to a PC is an optional accessory Contact your i TM authorised distributor or HeartSine 3 Launch the HeartSine Saver Technologies directly about the After Use EVO utility Data Management Service Notice The SAM 300P should only be connected to an 1 Connect the supplied USB IEC60950 PC cable to the SAM 300P see illustration below Caution You cannot defibrillate A while the SAM 300P is connected to a PC For further information on this optional accessory contact your authorised distributor or H
19. lation 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 In victims of SCA it is possible to re establish normal sinus rhythm by means of an electric shock across the heart This treatment is called defibrillation Introduction Recommended training SCA is a condition requiring immediate emergency medical intervention Due to the nature of the condition this intervention can be performed before seeking the advice of a physician To properly diagnose this condition HeartSine recommends that all potential users of the SAM 300P are fully trained in cardiopulmonary resuscitation CPR basic life support BLS and in particular the use of an automated external defibrillator HeartSine also recommends that this training be kept up to date by regular refresher courses as and when recommended by your training provider If potential users of the SAM 300P are not trained in these techniques contact your authorised distributor or HeartSine Technologies directly Either can arrange for training to be provided Alternatively contact your local government health department for information on certified training organisations in your region 10 CPR metronome The SAM 300P will play an audible click and flash the Safe To Touch indi
20. ll a paediatric Pad Pak If a paediatric Pak Pad or an alternative suitable defibrillator is not available you may use an adult Pad Pak 15 Using the SAM 300P After use Turn off the SAM 300P by pressing on the front panel Remove the electrode pads from the patient and stick them together face to face The electrodes may be contaminated with human bodily tissue fluid or blood Dispose of the electrodes separately as an infectious waste material The Pad Pak is a single use item and must be replaced after each use Remove the Pad Pak by pressing the two tabs on either side of the Pad Pak The Pad Pak will slide forward see the illustration below 16 Do not dispose of the SAM 300P or Pad Pak in the normal waste Dispose of it at an appropriate recycling facility according to local requirements Alternatively return it to your distributor for disposal or replacement Check the SAM 300P for dirt or contamination If necessary clean it using a soft cloth dampened by one of the following Soapy water Isopropyl alcohol 70 solution Caution Do not immerse any A part of the SAM 300P in water or any type of fluid Contact with fluids may seriously damage the device or cause a fire or a shock hazard Notice Do not clean the SAM 300P with abrasive materials cleaners or solvents Check the SAM 300P for damage If the SAM 300P is damaged replace it immediately Install a new Pad
21. red Meets ISO 60601 2 4 and AAMI DF80 2003 Attach Pads Stand Clear Perform CPR Shock now Self Test Pass Ready State Extensive voice prompts guide the user through the operation sequence Contact your HeartSine authorised distributor Two buttons On Off and Shock Defibrillator performance Times to shock delivery fresh battery or after 6 shocks Charging time Following CPR Impedance range Battery Battery type Battery capacity Standby life 24 Typically 150 J in lt 8 sec 200 J in lt 12 sec Typically 8 seconds 25 Q to 230 Q Disposable single use combined battery and defibrillation electrode cartridge lithium manganese dioxide LiMnO2 18V gt 60 shocks at 200 J or 6 hours of continuous monitoring See the expiry date on the product Electrodes Type Placement Active area Cable length Shelf life Therapeutic shock Waveform Energy Event recording Type Memory Review Single use pre attached combined ECG sensor defibrillation pad Adult anterior lateral Paediatric electrodes anterior posterior or anterior lateral 100 cm 3 5 ft 1m See the expiry date on the product SCOPE Self Compensating Output Pulse Envelope biphasic escalating waveform Optimised biphasic waveform compensates energy slope and envelope for patient impedance Pre configured factory settings for escalating energy are Version AHA ERC 2010 Adult 1 Shock 150 J 2 Shock 150 J 3
22. sh battery Temperature limitation as indicated Use by yyyy mm Dispose of in accordance with country requirements Automated External Defibrillator With respect to electrical shock fire and mechanical hazards only in accordance with e ANSI AAMI ES60601 1 2005 s CSA C22 2 NO 60601 1 2008 IEC60601 2 4 2010 UL60601 1 2006 CSA C22 2 No 601 1 M90 IEC60601 2 4 2002 l Warnings and Cautions A Warning Patients suitable for treatment The SAM 300P has been designed to work on unconscious nonresponsive patients If the patient is responsive or conscious do not use the SAM 300P to provide treatment The SAM 300P uses an interchangeable battery and electrode pack called Pad Pak The SAM 300P in combination with an adult Pad Pak is suitable for use on patients of over 25 kilograms 55 pounds in weight or equivalent to a child of approximately eight years old or over For use on children remove the adult Pad Pak and install a paediatric Pad Pak If a paediatric Pad Pak or an alternative suitable defibrillator is not available you may use an adult system Do not delay treatment trying to find out the patient s exact age and weight Risk of electric shock The SAM 300P delivers therapeutic electrical shocks that can cause serious harm to either operators or bystanders Take care to ensure that nobody touches the patient when a shock is to be delivered Avoid opening or repairing The SAM 300P has no ser
23. test our device Further Information Use of this manual It is important that you read this manual carefully before using the HeartSine Samaritan PAD SAM 300P This manual is presented in support of any training you may have received If you have any questions contact your authorised distributor or HeartSine Technologies directly for advice or explanation The information in this manual 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 l Warnings and Cautions Operator training HeartSine recommends that the SAM 300P is used by people trained in cardiopulmonary resuscitation defibrillation CPR D Use of accessories The SAM 300P is a self contained device Do not use any unauthorised accessories with it The SAM 300P may malfunction if non approved accessories are used Regular maintenance Check the device periodically See Service and Maintenance on page 18 Correct disposal of the device Dispose of the device in accordance with the European WEEE Directive or contact your HeartSine distributor Please follow the After use on page 16 Compliance with local regulations Check with the relevant local governm
24. viceable parts Do NOT open or repair the device under any circumstances as there could be danger of electric shock If damage is suspected replace the SAM 300P immediately Avoid explosive or flammable gases It has been determined that the SAM 300P is safe to use with oxygen mask delivery systems However to avoid the risk of an explosion it is strongly advised that you do NOT use the SAM 300P in the vicinity of explosive gases including flammable anaesthetics or concentrated oxygen A Caution Correct placement of the electrode pads Proper placement of the SAM 300P s electrode pads is critical You must strictly observe the instructions shown in the Quick Start Guide and on the device Wrong placement or the presence of air hair surgical dressings or medicine patches between the pads and the skin could cause skin burns Slightly red skin after shock therapy is normal Do not touch the patient during analysis 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 l Warnings and Cautions Do not use if the pouch containing the electrodes is not sealed The Pad Pak is a single use item and you must replace it after each use or if pouch that seals defibrillation pads has been broken or compromised in any way If you
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