User Manual HeartSine samaritan® PAD SAM 300P
Contents
1. 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 to application of the test level 35 Technical Data Guidance and manufacturer s declaration electromagnetic immunity The SAM 300P is intended for use in the electromagnetic environment specified below The customer or user of the SAM 300P must assure that it is used in such an environment IEC 60601 Compliance test level level2. 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 User Interface Visual prompts Attach pads stand clear perform CPR shock now self test pass ready state Audible prompts Extensive voice prompts guide the user through the operation sequence see List of Voice Prompts on page 39 Languages Contact your HeartSine authorised distributor Controls Two buttons On Off and Shock Defibrillator performance Times to shock delivery fresh battery or after 6 shocks Charging time Typically 150J in lt 8 sec 200 Jin lt 12 sec Following CPR Typically 8 seconds Impedance range 20 Q to 230 Q Therapeutic shock Waveform biphasic escalating waveform Optimised biphasic waveform compensates energy slope and envelope for patient impedance Energy Pre configured factory settings for escalating energy are Version AHA ERC 2010 29 Technical Data Event recording Type Internal memory Memory of ECG full disclosure and event incident recording Review Custom USB cable directly connected to a PC and Saver EVO Windows based data review software Electromagnetic compatibility EMC IEC60601 1 2 Radiated Emissions IEC55011 Electrostatic Discharge IEC61000 4 2 8 kV RF Immunitv IEC61000 4
3. 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 G ENI detectes a fault Contact vour authorised distributor 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 Pad Pak pack
4. 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 300P is used exceeds the applicable RF compliance level see above the 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 SAM 300P 37 Recommended separation distances between portable and mobile RF communication equipment and the SAM 300P The SAM 300P is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the SAM 300P can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equ
5. separately as an infectious waste material 3 The Pad Pak contains Lithium batteries 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 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 Notice Do not clean the SAM 300P with abrasive materials cleaners or solvents 18 5 Check the SAM 300P for damage If the SAM 300P 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 Electrode Placement The Pediatric Pak is intended to provide For pediatric patients there are two options therapy for pediatric child victims of for electrode placement SCA between the ages of 1 and 8 years a If a child s chest is small it may be Did whale necessary to place one pad on the child s Unconscious BARE chest in the center and the other pad on the child s BARE back in the center Not breathing of the ribcage as shown in Method a Without circulation 00
6. the illustration below Listen for the click sound and ensure both tabs are fully engaged r 3 1 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 13 will blink If so your SAM 300P is ready for use Ea 15 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 Preparation 6 Place the SAM 300P in its supplied Preparation checklist soft carry case Store the SAM 300P in an unobstructed secure U Step 1 Check the Pad Pak expiry date location in a clean dry environment 0 Step 2 Install the Pad Pak specifically where it will be seen and heard Be sure to store according to 4 Step 3 Check for a successful specifications see Technical Data completion of the self test routine on page 27 0 Step 4 Turn on to check operation Standby 0 to 50 C 0 Step 5 Turn off temperature 50 to 122 F U Step 6 Store the SAM 300P correctly Relative 5 to 95 humidity non condensing U Step 7 Register your SAM 300P Notice HeartSine recommends Il Step 8 Create a service schedule that vou keep a spare Pad Pak see Service and Maintenance with vour SAM 300P Vou can on page 22 store it in the rear section of the soft carrv case 7 Complete the guarantee card and return it to vour authorised distributo
7. 3 80 MHz 2 5 GHz 10 V m Magnetic Field Immunity IEC61000 4 8 3 A m Aircraft RTCA DO 160F Section 21 Category M RTCA DO 227 ETSO C142a 30 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 ener rotocol of 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 n jii 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 Roe Arrhyth
8. 8 ANTERIOR POSTERIOR Method a 20 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 Warning Defibrillation A electrodes must be at least 1 inch approx 2 5 cm apart and should never be touching one another HS A patients Not for use on A 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 0 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 on page 25 The SAM 300P 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 indica
9. 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 e CSA C22 2 NO 60601 1 2008 e IEC60601 2 4 2010 Follow instructions for use Indications for Use Indications for use Intended users The HeartSine samaritan PAD 300P is indicated for use on victims of cardiac arrest who are exhibiting the following signs Users should have received training in basic life support AED advanced life support or a physician l Unconscious authorized emergencv medical response 7 Not breathing training program 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 e Without circulation The samaritan PAD 300P is indicated for use on patients greater than 8 vears 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 300P is indicated for use on children between 1 and 8 vears 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 300P to provide treatment b Warnings and Cautions A War
10. HeartSine samaritan PAD SAM 300P User Manual Contents Contents Indications for Use Indications for use Contraindications for use Intended users Warnings and Cautions Introduction The SAM 300P Sudden cardiac arrest SCA Ventricular fibrillation Recommended training CPR metronome SAM 300P Overview Preparation Unpacking Checks before putting into service Preparation checklist Using the SAM 300P When to use Using the SAM 300P After use RSP BR ND 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 22 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 i Further information Symbols used on this device On Off according to EN 60529 Consult operating instructions Single use item Do not re use Og gt d w x lt zZ o A 2 SJ IM KIS KOS B B Z EN an 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
11. Immunity test Electromagnetic environment guidance Conducted RF 3 Vrms Not IEC EN 61000 4 6 150 kHz to 80 MHz applicable outside ISM bands Not applicable 10 Vrms Not 150 kHz to 80 MHz applicable Notapplicabie in ISM bands Radiated RF 10 V m 10 V m Fe a3 80 Mewes cue 80MHz 4512 VP 80 MHz to 800 MHz CIEN 61000 4 3 80 MHz to 2 5 GHz 452 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 36 Guidance and manufacturer s declaration electromagnetic immunity compliance level in each frequency range Interference 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
12. It is important that you read this manual carefully before using the 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 p Warnings and Cautions Operator training The samaritan PAD 300P is intended for use by personnel who have been trained in its operation 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 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 10 Compliance with local regulations Check with the relevant local government health department for information about any requirements associated with ownership and use o
13. aging is not returned The device has been tested using unapproved methods or inappropriate equipment see Warnings and Cautions on page 6 Technical Data Environmental Operating temperature Standby temperature Transport temperature Relative humidity Enclosure Altitude Shock Vibration Physical parameters with Pad Pak installed 0 to 50 C 32 to 122 F 0 to 50 C 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 Battery type Battery capacity new lithium manganese dioxide hours of continuous monitoring Battery capacity 4 years 510 shocks or 20 mins of continuous monitoring Standby life Electrode type Electrode placement Electrode active area Electrode cable length Electrode shelf life 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
14. atus indicator When the indicator is flashing green the SAM 300P is ready for use Data port 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 Safe to touch icon to deliver a It is safe to touch the therapeutic shock Dr fe patient when the action arrows around this icon are flashing jie A TR P B a ww ready icon ho e 7 a Action arrows On Off button Press this button to turn the device on or off Do not touch icon Do not touch the patignt when the action arrows around this icon are Speaker flashing The SAM 300P may be analysing the patient s heart rhythm i or about to charge Green tab Electrode drawer preparing to deliver a 13 shock 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 passed you must replace the Pad Pak coloured 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 300P on a flat surface Insert the Pad Pak into the SAM 300P see
15. eflection from structures objects and people List of Voice Prompts Listed below are the voice prompts used by the SAM 300P 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 chest in time with the metronome Remain calm 39 Authorised Distributor www heartsine com info heartsine com US Americas EMEA ASP CE HeartSine Technologies Inc HeartSine Technologies 121 Friends Lane Suite 400 203 Airport Road West 0120 Newtown PA 18940 Belfast NorthernirelandBT39ED Te
16. f a defibrillator in the region where it is to be used Introduction The SAM 300P The 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 and effective 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 fibrillation The normal electrical rhythm by which the heart muscle contracts to create blood flow around the body is known as normal sinu
17. hythms Specificity 95 95 04 No error to measure 33 Technical Data Guidance and manufacturer s declaration electromagnetic emissions The SAM 300P is intended for use in the electromagnetic environment specified below The customer or user of the SAM 300P must assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance The SAM 300P 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 Net appli abie 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 Net applicable 34 Guidance and manufacturer s declaration electromagnetic immunity The SAM 300P is intended for use in the electromagnetic environment specified below The customer or user of the SAM 300P 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
18. ipment transmitters and the SAM 300P as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of transmitter output power of m transmitter 1450 kHz to 80 MHz 150 kHzto 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5GHz outside ISM bands in ISM bands d 1 2 VP d 2 3 SP For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres 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 the 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 r
19. l 215 860 8100 Toll Free 866 478 7463 Tel 44 0 28 9093 9400 H017 019 100 0 Fax 215 860 8192 Fax 44 0 28 9093 9401 English US
20. mia analysis algorithm Resistance Energy ET e The SAM 300P uses the HeartSine ohms joules samaritan ECG arrhythmia analysis algorithm This algorithm will evaluate the patient s ECG to ascertain if a therapeutic 25 47 5 514 55 6 7 8 5 4 shock is appropriate If a shock is required 20 513 671 50 4 88 6 the SAM 300P will charge and advise the 75 52 1 754 47 1 10 6 6 user to press the shock button If no shock 100 51 8 813 44 3 10 8 6 8 is advised the device will pause to allow 125 524 858 41 4 11 5 7 3 the user to deliver CPR Pediatric Pak waveform specification All values are nominal 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 and specificity meet the requirements of IEC60601 2 4 32 The SAM 300P ECG arrhythmia analysis algorithm performance is summarised in the table below ECG Test 90 One Sample Redulted Performance Sided Lower Size me Results Confidence Specifications r Sas seconds Limit Rhythm Class Shockable Rhythm Ventricular Fibrillation VF and 2453 Sensitivity gt 90 93 48 90 58 Ventricular Tachycardia VT Non Shockable Rhythm on shackable Rhythim 1902 Specificity gt 95 100 100 Asystole Non Shockable Rhythm e All other r
21. ning 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 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 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 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 strongl advised that you A Caution Correct placement of the electrode pads Proper placement of the SAM 300P s electrode pads is critical Slightly red skin after shock therapy is normal Do not touch the patient during analysis T
22. ouching 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 p Warnings and Cautions Do not use if the pouch containing the electrodes is not sealed t Notice The Pad Pak is a single use item and you nal must replace it after each use or if the suseepeniity to slsgiromagnene pouch that seals defibrillation pads has interference been broken or compromised in any way If To Safeguard against interference you you suspect that the Pad Pak is damaged Must operate the SAM 300P at least 2 m you must replace it immediately 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 Ingress 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 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 Further Information Use of this manual
23. pdated information 23 Data Management The HeartSine Saver EVO software is an 2 optional accessory Contact your authorised distributor or HeartSine Technologies 3 Launch the HeartSine Saver directly about the After Use Data Eve aul Management Service Notice The SAM 300P should A oniv be connected toan 1 Connect the supplied USB cable to the IEC60950 PC SAM 300P see illustration below Caution Vou cannot defibrillate while the SAM 300P is connected to a PC For further information on this optional accessorv contact vour authorised distributor or HeartSine Technologies directiv 24 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 expir date has not been passed 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 IET 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 However the device can still analyse and deliver a shock if required If you hear this message contact HeartSine Technologies technical support Audible warnings his beeping
24. r or HeartSine Technologies directiv see Tracking Requirements on page 23 16 Using the SAM 300P When to use Using the SAM 300P The SAM 300P is indicated for use on Refer to the separate Emergency User victims of sudden cardiac arrest who are Guide During use the SAM 300P will give exhibiting the following signs extensive voice prompts to guide a user For full list of voice prompts see List of Unconscious Voice Prompts on page 39 Not breathing Without circulation t 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 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 17 Using the SAM 300P After use 1 Turn off the SAM 300P by pressing on the front panel 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 2 Remove the electrode pads from requirements Alternatively return the patient and stick them together face to face The electrodes may be contaminated with human bodily it to your distributor for disposal or replacement Check the SAM 300P for dirt or tissue fluid or blood Dispose of the electrodes
25. s 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 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 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 12 CPR metronome 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 300P Overview Attach pads icon St
26. tor continues to flash red the SAM 300P has a fault see Troubleshooting on page 25 a Ifthe device shows any signs of physical damage contact your authorised distributor or HeartSine Technologies directly 0 Check the expiry date of the SAM 300P 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 300P or if for any reason you have suspicions that your SAM 300P 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 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 contact us with the u
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