User Manual HeartSine samaritan® PAD SAM 500P
Contents
1. User Interface Visual prompts Audible prompts Languages Controls Attach pads stand clear perform CPR shock now self test pass ready state Extensive voice prompts guide the user through the operation sequence see List of Voice Prompts on page 41 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 Therapeutic shock Waveform Energy Typically 150J in lt 8 sec 200 J in lt 12 sec Typically 8 seconds 20 Q to 230 Q 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 Shock 1 150J Shock 2 150J Shock 3 200J Paediatric Shock 1 50J Shock 2 50J Shock 3 50J 29 Technical Data Event recording Type Memory Review 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 Electromagnetic compatibility EMC Radiated Emissions Electrostatic Discharge RF Immunity Magnetic Field Immunity Aircraft 30 IEC60601 1 2 IEC55011 IEC61000 4 2 8 kV IEC61000 4 3 80 MHz2. 12 CPR metronome During CPR the SAM 500P will play an audible beep and flash the Safe To Touch indicator at a rate compliant with 2010 AHA ERC guidelines This feature is referred to as the CPR metronome Use the metronome as a guide on how frequently to compress a patient s chest if you need to apply CPR SAM 500P Overview Attach pads icon Status indicator Data port When the indicator is flashing green the SAM 500P is ready for use The action arrows around this icon will flash to instruct you to attach the electrode pads to the patient as indicated Shock button Press this button to deliver a therapeutic shock Do not touch icon Do not touch the patient when the action arrows around this icon are flashing The SAM 500P may be analysing the patient s heart rhythm or about to charge preparing to deliver a shock Paediatric ready icon 5 CPR advisor Y Action arrows On Off button Press this button to turn the device on or off Safe to touch icon Speaker It is safe to touch the patient when the action arrows a around this icon are flashing Green tab Electrode drawer Preparation Unpacking Checks before putting into service Check that the contents include the User 1 Check the expiry date year month Manual soft case Pad Pak guarantee on the rear of the Pad Pak see card and Emergency User Guide the illustration below If the expiry date has pa
3. 2 5 GHz 10 V m IEC61000 4 8 3 A m RTCA DO 160F Section 21 Category M RTCA DO 227 ETSO C142a SCOPE Biphasic Waveform The SAM 500P 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 T2 is always a constant 0 4 ms for all patient impedances The specific SCOPE waveform characteristics for a 150 joules pulse are listed opposite T T T T T T T T 23456789 Duration msec r Waveform Duration ms Waveform Voltages volts Resistance ohms Tilt 25 1640 63 1 50 1650 52 7 75 1660 51 4 6 5 6 5 100 1670 48 7 8 8 125 1670 50 4 10 5 10 5 150 1670 48 7 12 12 175 1670 48 7 14 14 200 1670 47 6 15 5 15 5 225 1680 46 7 17 17 Adult Pad Pak waveform specification All values are nominal 31 Technical Data Noe Arrhythmia analysis algorit
4. been broken or compromised in any way If you 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 500P at least 2 m 6 feet away from all radio frequency devices Alternatively switch off the equipment causing the electromagnetic interference Temperature range for operation The SAM 500P 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 Ingress protection The IP56 rating does not cover the immersion of any part of the SAM 500P in water or any type of fluid Contact with fluids may seriously damage the device or cause fire or a shock hazard l Warnings and Cautions Prolonging battery life Do not turn on the device 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 Pad Pak Do not test on simulators and manikins Our devices cannot be tested using industry standard simulators and manikins 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 test our device Further Information Use of this manual It is important that you read thi
5. 95 38 Sensitivity gt 83 40 Specificity gt 90 Specificity gt 93 11 Specificity gt 82 19 CPR force 108728 Sensitivity gt 90 Sensitivity gt 99 96 Sensitivity gt 99 54 adequate Specificity gt 90 Specificity gt 98 47 Specificity gt 96 29 34 Paediatric restriction Use of the CPR Advisor function must be restricted to adult patients only Chest compression techniques differ for the different ages and sizes of paediatric patients up to eight years old For younger paediatric patients rescuers should compress the lower half of the sternum but not compress over the xiphoid For patients at the upper end of the paediatric range adult style compressions should be performed The force required for the paediatric patients is less than that required in adult CPR CPR advisor is currently configured only to advise compressions at a force and rate suitable for adult patients over eight years old weighing more than 25 kgs 55 Ibs Electrode placement may also differ in paediatric patients Depending on the patient size the electrodes may be placed anterior posterior front and back or anterior lateral standard adult placement Differing electrode positions may result in different ICG readings Current technology does not support CPR advisor in determining which electrode placements are being used and therefore electrodes must be placed anterior lateral for CPR advisor to function correctly For these reasons CPR adviso
6. arrest who are exhibiting the following signs Unconscious Not breathing Without circulation The SAM 500P has been designed to work on unconscious nonresponsive patients If the patient is responsive or conscious do not use the SAM 500P to provide treatment The SAM 500P 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 smaller children from 1 to 8 years old remove the adult Pad Pak and install a Pediatric Pak If a Pediatric Pak or an alternative suitable defibrillator is not available you may use an adult Pad Pak Using the SAM 500P Refer to the separate Emergency User Guide During use the SAM 500P will give extensive voice prompts to guide a user For full list of voice prompts see List of Voice Prompts on page 41 Notice The SAM 500P aborts 1 a ready to shock condition once a non shockable rhythm is detected 17 Using the SAM 500P After use 1 Turn off the SAM 500P by pressing on the front panel 2 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 3 The Pad Pak contains Lithium batteries It is a single use item and must be replaced after each use Remove the Pad Pak by pressing the two tabs on either si
7. on page 25 The SAM 500P performs a self test routine at midnight GMT every Sunday During this self test 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 500P has a fault see Troubleshooting on page 25 Monthly 0 If the device shows any signs of physical damage contact your authorised distributor or HeartSine Technologies directly oO Check the expiry date of the SAM 500P Pad Pak see Preparation on page 14 for the location of the date If the date has expired or is near expiry replace with a new Pad Pak or contact your local HeartSine distributor for a replacement If you hear a warning message when you turn on your SAM 500P or if for any reason you have suspicions that your SAM 500P is not working correctly read the section Troubleshooting on page 25 22 Tracking Requirements 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 Alternatively send an email to support heartsine com containing Name Address Device serial number or use our on line registration tool at https secure heartsine com UserRegistration html Your participation will allow us t
8. 32 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 1 40G s MIL STD 810F Method 514 5 Procedure 1 Category 4 MIL STD 810F Method 514 5 Procedure 1 Category 7 27 Technical Data Pad Pak and Pediatric Pak Weight Battery type Battery capacity new Battery capacity 4 years Standby life Electrode type Electrode placement Electrode active area Electrode cable length Electrode shelf life 0 2 kg 0 44 Ibs Disposable single use combined battery and defibrillation electrode cartridge lithium manganese dioxide LiMnO 18V gt 60 shocks or 6 hours of continuous monitoring gt 10 shocks or 20 mins of continuous monitoring See the expiry date on the Pad Pak Single use pre attached combined ECG sensor defibrillation pad Adult anterior lateral Paediatric electrodes anterior posterior or anterior lateral 100 cm 3 5 ft 1 m See the expiry date on the Pad Pak Patient analysis system Method Sensitivity Specificity 28 Evaluates the patient s ECG signal quality electrode contact integrity and patient impedance to determine if defibrillation is required Meets IEC 60601 2 4
9. AM 500P has no serviceable 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 500P immediately i Warnings and Cautions Avoid explosive or flammable gases It has been determined that the SAM 500P 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 500P 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 500P s electrode pads is critical You must strictly observe the instructions shown in the Emergency User 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 reduce defibrillation effectiveness 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 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 the pouch that seals defibrillation pads has
10. Does not contain natural rubber latex Non sterile Recyclable Non rechargeable battery Do not short circuit battery Do not crush 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 CSA C22 2 NO 60601 1 2008 e IEC60601 2 4 2010 Follow instructions for use Indications for Use Indications for use The HeartSine samaritan PAD 500P is indicated for use on victims of cardiac arrest who are exhibiting the following signs Unconscious Not breathing Without circulation The samaritan PAD 500P is indicated for use on patients greater than 8 years old or over 55 Ibs 25 kg when used with the adult samaritan Pad Pak Pad Pak 01 or Pad Pak 07 The samaritan PAD 500P is indicated for use on children between 1 and 8 years of age or up to 55 Ibs 25 kg when used with the samaritan Pediatric Pak Pad Pak 02 Contraindications for use If the patient is responsive or conscious do not use the SAM 500P to provide treatment Intended users The samaritan PAD 500P is intended for use by personnel who have been trained in its operation Users should have received training in basic life support AED advanced life support or a physician authorized emergency medical response training progr
11. HeartSine samaritan PAD SAM 500P User Manual Contents Contents Indications for Use Indications for use Contraindications for use Intended users Warnings and Cautions Introduction The SAM 500P Sudden cardiac arrest SCA Ventricular fibrillation CPR quality Impedance cardiogram Recommended training CPR metronome SAM 500P Overview Preparation Unpacking Checks before putting into service Preparation checklist Using the SAM 500P When to use Using the SAM 500P After use Pediatric Pak Service and Maintenance Tracking Requirements Data Management Troubleshooting Status indicator flashing red Low battery warning Memory full warning Audible warnings Device service required Sources of support Warranty exclusion Technical Data List of Voice Prompts Adult patient child patient If a shock is not required If a shock is required Symbols used in this manual A i Warning Risk of death or serious injury Caution Risk of injury Notice Risk of damage to data or material Further information Symbols used on this device IP56 BE On Off Ingress protection classified as IP56 according to EN 60529 Consult operating instructions Single use item Do not re use P w 1G 9 gt na 2 s A xi DI DH amp jii Z Z N Defibrillation protected Type BF connection Do not expose to high heat or open flame Do not incinerate
12. Turn off the SAM 500P by pressing on the front panel Check the status indicator see SAM 500P Overview on page 13 is flashing green If you have heard no warning messages and the status indicator is flashing green the device is ready for use 15 Preparation 6 Place the SAM 500P in its supplied soft carry case Store the SAM 500P in an unobstructed secure location in a clean dry environment specifically where it will be seen and heard Be sure to store according to specifications see Technical Data on page 27 Standby 0 to 50 C temperature 50 to 122 F Relative 5 to 95 humidity non condensing Notice HeartSine recommends that you keep a spare Pad Pak with your SAM 500P You can store it in the rear section of the soft carry case H 7 Complete the guarantee card and return it to your authorised distributor or HeartSine Technologies directly see Tracking Requirements on page 23 Preparation checklist 0 0 0 Ooo oO J Step 1 Check the Pad Pak expiry date Step 2 Install the Pad Pak Step 3 Check for a successful completion of the self test routine Step 4 Turn on to check operation Step 5 Turn off Step 6 Store the SAM 500P correctly Step 7 Register your SAM 500P Step 8 Create a service schedule see Service and Maintenance on page 22 Using the SAM 500P When to use The SAM 500P is indicated for use on victims of sudden cardiac
13. am Caution Within the United States of America federal U S law restricts this device to sale by or on the order of a licensed practitioner Warnings and Cautions A Warning Patients suitable for treatment The SAM 500P has been designed to work on unconscious nonresponsive patients If the patient is responsive or conscious do not use the SAM 500P to provide treatment The SAM 500P uses an interchangeable battery and electrode pack called Pad Pak The SAM 500P 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 smaller children from 1 to 8 years old remove the adult Pad Pak and install a Pediatric Pak If a Pediatric Pak or an alternative suitable defibrillator is not available you may use an adult system If you treat a paediatric patient with an adult Pad Pak ignore any voice prompts regarding the quality of the cardiopulmonary resuscitation CPR The CPR Advisor is currently only intended to provide feedback on adult patients Do not delay treatment trying to find out the patient s exact age and weight Risk of electric shock The SAM 500P 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 S
14. de of the Pad Pak The Pad Pak will slide forward see the illustration below Do not dispose of the SAM 500P 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 500P 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 part of the SAM 500P in water or any type of fluid Contact with fluids may seriously damage the device or cause a fire or a shock hazard 500P with abrasive materials cleaners or solvents t Notice Do not clean the SAM 5 Check the SAM 500P for damage If the SAM 500P is damaged replace it immediately 6 Install a new Pad Pak Before installing check the Pad Pak expiry date see Preparation on page 14 After installation check the status indicator is blinking green Pediatric Pak Using the Pediatric Pak The Pediatric Pak is intended to provide therapy for pediatric child victims of SCA between the ages of 1 and 8 years old who are Unconscious Not breathing Without circulation 20 Electrode Placement For pediatric patients there are two options for electrode placement a If a child s chest is small it may be necessary to place one pad on the child s BARE chest in the cen
15. ded for use in the electromagnetic environment specified below The customer or user of the SAM 500P must assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC EN 61000 4 2 6 kV contact 8 kV air Complies Complies Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC EN 61000 4 4 2kV for power supply lines 1 kV for input output lines Not Applicable Not Applicable Not Applicable Surge IEC EN 61000 4 5 1kV differential mode 2 kV common mode Not Applicable Not Applicable Not Applicable Voltage dips short interruptions and voltage variations on power supply input lines IEC EN 61000 4 11 lt 5 Ut gt 95 dip in Ut for 0 5 cycle 40 Ut 60 dip in Ut for 5 cycles 70 Ut 30 dip in Ut for 25 cycles lt 5 Ut gt 95 dip in Ut for 5 sec Not Applicable Not Applicable Not Applicable Not Applicable Not Applicable Power frequency 50 60 Hz magnetic field IEC EN 61000 4 8 3 A m 3A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Note Ut is the a c mains voltage prior
16. e frequency range 80MHz to 2 5GHz to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas NOTE 4 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people List of Voice Prompts Listed below are the voice prompts used by the SAM 500P Read the voice prompts in advance of use to be familiar with the types of instructions given Adult patient child patient Call for medical assistance Remove clothing from patient s chest to expose bare skin Pull green tab to remove pads Peel pads from liner Apply pads to patient s bare chest as shown in picture Press pads firmly to patient s bare skin Assessing heart rhythm do not touch the patient If a shock is not required No shock advised Begin CPR It is safe to touch the patient Place overlapping hands in middle of chest Press directly down on the chest in time with the metronome Remain calm 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 in middle of chest Press directly down on the ches
17. h 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 SAM 500P The SAM 500P is a semi automatic external defibrillator designed to quickly deliver a defibrillation shock to victims of sudden cardiac arrest SCA The SAM 500P 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 and effective cardiopulmonary resuscitation CPR 10 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 fibrillation The normal electrical rhythm by w
18. hich 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 CPR quality When providing cardiopulmonary resuscitation CPR treatment to a victim of sudden cardiac arrest it is vital the chest compressions are of a good quality If the quality of the CPR provided is good the chances of successfully resuscitating a patient are greatly increased Research has demonstrated that non professional responders regularly provide ineffective CPR due to inexperience As a response to this problem HeartSine has developed the SAM 500P with CPR Advisor The SAM 500P with CPR Advisor can provide feedback to rescuers on the effectiveness of the cardiopulmonary resuscitation CPR they are providing to the victim The SAM 500P uses ICG measurements to analyse the effectiveness and rate of compressions given and then based on this analysis advises the rescuer to push harder faster or slower as appropriate The SAM 500P uses both audible and visual prompts to give the responder feedback on the quality of the compressions administered Warning The CPR Advisor function is intended for use on adult patie
19. hm Ea RR E XUR The SAM 500P uses the HeartSine cae Aone vole ms samaritan ECG arrhythmia analysis algorithm This algorithm will evaluate the patient s ECG to ascertain if a therapeutic 47 5 514 55 6 78 54 shock is appropriate If a shock is required 30 51 3 671 5044 88 6 the SAM 500P will charge and advise the 75 52 1 r51 47 1 10 6 6 user to press the shock button If no shock 100 51 8 813 44 3 10 8 6 83 is advised the device will pause to allow 125 52 4 858 41 4 11 5 7 3 the user to deliver CPR Pediatric Pak waveform specification The SAM 500P ECG arrhythmia analysis Alivaluesare nominal 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 500P ECG arrhythmia analysis algorithm s sensitivity and specificity meet the requirements of IEC60601 2 4 32 The SAM 500P ECG arrhythmia analysis algorithm performance is summarised in the table below ECG Test Required 90 One Sample q Performance Sided Lower Performance Size TETEE Results Confidence Specifications SERA seconds Limit Rhythm Class Shockable Rhythm RD Ventricular Fibrillation VF 14538 Sensitivity gt 90 97 03 95 31 Shockable Rhythm eR 2321 tiv
20. ity gt 759 2 52 Ventricular Tachycardia VT SENSUM yek ret o 99 3 Non Shockable Rhythm oe Combined Non Shockable Rhythms 301177 Specificity gt 95 98 30 95 02 Non Shoekable Rhythim 11507 Specificity gt 95 100 100 Asystole No error to measure 33 The following summary shows the results produced by the CPR component of the diagnostic algorithm when run against the clinical database The importance of administering effective chest compressions can mean the difference between a patient having a good quality of life following a cardiac arrest and having the misfortune of suffering neurological impairment due to inadequate cerebral oxygenation Most modern defibrillators and mechanical resuscitation systems have a metronome facility to ensure an operator administers CPR at the correct rate A feedback system to ensure the operator delivers compressions at the correct depth so enabling adequate re filling time would optimise coronary perfusion pressures Impedance cardiography ICG measures the changes of shape and movement of blood in the thorax which can be a useful indicator of perfusion levels during external cardiac massage The impedance cardiogram can be accurately measured using two standard defibrillator electrodes Combining both the force and speed CPR management tools will enhance CPR efficacy for both lay users and minimally trained bystanders CPR speed good 82377 Sensitivity gt 90 Sensitivity gt
21. may occur in the vicinity of equipment marked with the following symbol C 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 ISM industrial scientific and medical bands between 150kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 to MHz 13 567 MHz 26 957 to MHz 27 283 MHz 40 66 to MHz 40 70 MHz b 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 c 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 where the SAM 500P is used exceeds the applicable RF compliance level see above the SAM 500P
22. nts only If a Pediatric Pak is used the CPR function is disabled In this case the rescuer is prompted to begin CPR but receives no CPR Advisor feedback Impedance cardiogram ICG The impedance cardiogram is a method of measuring changes in the patient s impedance due to motion blood flow and changes to the shape of the heart The SAM 500P uses these measurements to estimate the impedance changes in the chest and so as a way to determine the effectiveness of compressions given during CPR 11 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 500P 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 500P 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
23. o contact you with any important notifications about the SAM 500P 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 500P contact us with the updated information 23 Data Management The HeartSine Saver EVO software is an optional accessory Contact your authorised distributor or HeartSine Technologies directly about the After Use Data Management Service 1 Connect the supplied USB cable to the SAM 500P see illustration below 24 2 Connect the USB cable to a PC 3 Launch the HeartSine Saver EVO utility Notice The SAM 500P should Hi only be connected to an IEC60950 PC Caution You cannot defibrillate while the SAM 500P is connected to a PC For further information on this optional accessory contact your authorised distributor or HeartSine Technologies directly 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 14 If the expiry date has not been passed turn on the SAM 500P 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 dist
24. r is disabled when a Pediatric Pak is used in the SAM 500P Notice The ECG readings used to determine if the patient requires a defibrillation shock are not affected by the electrode positions selected in paediatric patients ignore the prompts provided The CPR Advisor is currently only intended Warning If a paediatric patient is treated with an adult Pak Pad you must to provide feedback on adult patients 35 Technical Data idance and manufacturer s declaration electromagnetic emissions The SAM 500P is intended for use in the electromagnetic environment specified below The customer or user of the SAM 500P must assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance The SAM 500P uses RF 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 Group 1 RF emissions CISPR 11 Class B The device is suitable for use in all establishments Harmonic emissions IEC Not applicable including domestic and those directly connected to to EN 61000 3 2 PP the public low voltage power supply network that supplies buildings used for domestic purposes Voltage fluctuations flicker emissions IEC EN 61000 3 3 Not applicable 36 Guidance and anufacturer s declaration electromagnetic immunity The SAM 500P is inten
25. r or HeartSine directly for further instruction Warning If you hear this message during use seek an alternative defibrillator immediately No modification of this equipment is allowed 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 26 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 indicated 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 5 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
26. ributor or HeartSine Technologies immediately Low battery warning This message does not indicate a fault 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 prepare the spare Pad Pak for use and be prepared to swap it quickly Order a new Pad Pak as soon as possible Memory full warning If the device plays the message 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 the specified operating range This beeping could also occur during the weekly self test If you hear this beeping please ensure the device is returned to the specified operating conditions 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 25 Troubleshooting Device service required If the device plays the message device service required then it has detected a fault Contact your authorised distributo
27. s manual carefully before using the SAM 500P 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 Operator training The samaritan PAD 500P is intended for use by personnel who have been trained in its operation Users should have received training in basic life support AED advanced life support or a physician authorized emergency medical response training program Use of accessories The SAM 500P is a self contained device Do not use any unauthorised accessories with it The SAM 500P may malfunction if non approved accessories are used Regular maintenance Check the device periodically See Service and Maintenance on page 22 Correct disposal of the device Dispose of the device in accordance with your national or local regulations or contact your HeartSine distributor Please follow the After use on page 18 Compliance with local regulations Check with the relevant local government healt
28. 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 SAM 500P 39 The SAM 500P is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the SAM 500P can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the SAM 500P as recommended below according to the maximum output power of the communications equipment too herapgiean e notappicane fa _ d or transmitters rated at a maximum output power not listed above the recommended separation distance d in na m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts w according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 The ISM industrial scientific and medical bands between 150kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 to MHz 13 567 MHz 26 957 to MHz 27 283 MHz 40 66 to MHz 40 70 MHz NOTE 3 An additional factor of 10 3 has been incorporated into the formulae used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150kHz and 80 MHz and in th
29. ssed you must replace A Pad Pak is a single use removable battery and electrode pack in one unit It is available in two versions grey coloured Pad Pak for use with adults and a pink coloured Pad Pak for use with children see the illustration below the Pad Pak Adult Pad Pak Pediatric Pak 1 A third version is also available specifically for airlines 14 2 Unpack the Pad Pak Retain the packaging in case you need to return the Pad Pak to HeartSine Place the SAM 500P on a flat surface Insert the Pad Pak into the SAM 500P see the illustration below Listen for the click sound and ensure both tabs are fully engaged 3 If required the SAM 500P 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 500P Overview on page 13 will blink If so your SAM 500P is ready for use 4 Turn on the SAM 500P by pressing on the front panel to check that the device is operating correctly Listen for the voice prompts but do NOT follow them Make sure that no warning messages are played Notice Do NOT pull the green tab on the Pad Pak If you have opened the electrode drawer you may have to replace your Pad Pak Only turn the SAM 500P on ONCE If you turn it on and off repeatedly you will exhaust the batteries prematurely and you may need to replace the Pad Pak 5
30. t in time with the metronome Remain calm 41 43 Authorised Distributor www heartsine com info heartsine com US Americas HeartSine Technologies Inc 121 Friends Lane Suite 400 Newtown PA 18940 Tel 215 860 8100 Toll Free 866 478 7463 Fax 215 860 8192 EMEA ASP HeartSine Technologies 203 Airport Road West Belfast Northern Ireland BT3 9ED Tel 44 0 28 9093 9400 Fax 44 0 28 9093 9401 CE 0120 H017 019 200 0 English US
31. ter and the other pad on the child s BARE back in the center of the ribcage as shown in Method a ADA he ANTERIOR POSTERIOR Method a b If a child s chest is large enough to permit a 1 inch 2 5cm gap between the pads pad placement can be used similar to adult placement Place one pad on child s BARE upper right chest above nipple and one pad on child s BARE lower left ribcage below nipple as shown in Method b Method b Electrodes can be placed on the child s chest if their chest is large enough OR if trauma does not allow for the placement as shown in Method a gt gt Warning Defibrillation electrodes must be at least 1 inch approx 2 5 cm apart and should never be touching one another Warning The Pediatric Pak contains a magnetic component surface strength 6500 gauss Avoid storage next to magnetically sensitive storage media Warning Not for use on patients under 1 year old For use with children up to the age of 8 years or up to 55lbs 25kg DO NOT DELAY THERAPY IF YOU ARE NOT SURE OF EXACT AGE OR WEIGHT 21 Service and Maintenance HeartSine recommends users perform regular maintenance checks The recommended maintenance checks are Weekly oO Check the status indicator If the green status indicator is not flashing every 5 to 10 seconds or if the red status indicator is flashing or if you hear beeping a problem has been detected See Troubleshooting
32. to application of the test level 37 Technical Data anufacturer s declaration electromagnetic immunity The SAM 500P is intended for use in the electromagnetic environment specified below The customer or user of the SAM 500P must assure that it is used in such an environment Immunity test IEC 60601 Compliance Electromagnetic environment guidance test level level Portable and mobile RF communications equipment should be used no closer to any part of the SAM 500P including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms Not Not applicable IEC EN 61000 4 6 150 kHz to 80 MHz applicable outside ISM bands 10 Vrms Not Not applicable 150 kHz to 80 MHz applicable in ISM bandsa 10 V m Radiated RE va 80 MHz dis 1 2 VP 80 MHz to 800 MHz IEC EN 61000 4 3 80 MHz to 2 5 GHz to 2 5 GHz 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 distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the next page 38 Guidance and manufacturer s declaration electromagnetic immunity compliance level in each frequency range Interference
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