User Manual samaritan® PAD 450P SAM 450P
Contents
1. The SAM 450P is intended for use in the electromagnetic environment specified below The customer or user of the SAM 450P 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 6 kV contact 8 kV air 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 Surge IEC EN 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC EN 61000 4 11 1kV differential mode 2 kV common mode 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 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 Technical Data nufac2. HeartSine Inventor Innovator Lifesaver samaritan PAD 450P SAM 450P User Manual Contents Contents Indications for Use Indications for use Contraindications for use Intended users Warnings and Cautions Introduction The SAM 450P Sudden cardiac arrest SCA Ventricular fibrillation CPR Rate Advisor Impedance cardiogram Recommended training CPR metronome SAM 450P Overview Preparation Unpacking Checks before putting into service Preparation checklist Using the SAM 450P When to use Using the SAM 450P After use O nA KR BP BD 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 CPR Rate Advisor If a shock is not required If a shock is required Symbols used in this manual Symbols used on this device Warning Risk of death or serious injury Caution Risk of injury Notice Risk of damage to data or material Further information On Off Ingress protection classified as IP56 according to IEC 60529 a a a Consult operating instructions Single use item Do not re use k Defibrillation protected Type BF connection Do not expose to high heat or open flame Do not incinerate xE X DOs KK 8 H
3. 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 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 Rate Advisor 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 450P with CPR Rate Advisor The SAM 450P with CPR Rate Advisor provides feedback to the rescuers on the rate of the cardiopulmonary resuscitation CPR they are providing to the victim The SAM 450P uses impedance cardiogram measurements to analyze the speed of compressions and provide the user with instructions to push faster or push slower or to continue to provide compressions at an optimal speed according to the AHA resuscitation guidelines The SAM 450P uses both
4. Check the expiration date year Manual soft case Pad Pak Registration month day on the rear of the Pad and Warranty Card and Emergency Pak see the illustration below If the User Guide expiration date has passed you must P l the Pad Pak A Pad Pak is a single use removable oplaca Me pagka battery and electrode pack in one unit It is available in two versions gray colored Pad Pak for use with adults and a pink colored Pediatric Pak for use with children see the illustration below 2017 05 01 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 450P on a flat surface Insert the Pad Pak into the SAM 450P see the illustration below Listen for the click sound and ensure both tabs are fully engaged n yY 3 If required the SAM 450P 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 450P Overview on page 13 will blink If so your SAM 450P is ready for use 4 Turn on the SAM 450P 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 ta
5. audible and visual feedback to give the responder instruction on CPR rate Warning The CPR Rate Advisor function is intended for use on adult patients 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 Rate 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 450P uses these measurements to estimate the impedance changes in the chest as a way to determine the effectiveness of compression rate 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 450P 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 450P are not trained in these techniques contact your authorized or HeartSine Technologies directly Either can arrange for training
6. delivered Avoid opening or repairing The SAM 450P 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 450P immediately i Warnings and Cautions Avoid explosive or flammable gases It has been determined that the SAM 450P 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 450P in the vicinity of explosive gases including flammable anesthetics or concentrated oxygen A Caution Correct placement of the electrode pads Proper placement of the SAM 450P 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
7. AGE OR WEIGHT 21 Service and Maintenance HeartSine recommends users perform 0 Check the expiration date of the SAM regular maintenance checks The 450P Pad Pak see Preparation on recommended maintenance checks are page 14 for the location of the date If the date has expired or is near Weekly expiration replace with a new Pad 0 Check the status indicator If the Pak or contact your local HeartSine green status indicator is not flashing authorized distributor for a replacement every 5 to 10 seconds or if the red If you hear a warning message when status indicator is flashing or if you you turn on your SAM 450P or if for hear beeping a problem has been any reason you have suspicions that detected See Troubleshooting on your SAM 450P is not working correctly page 25 The SAM 450P performs read the section Troubleshooting a self test routine at midnight GMT on page 25 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 450P has a fault see Troubleshooting on page 25 Monthly a If the device shows any signs of physical damage contact your authorized distributor or HeartSine Technologies directly Tracking Requirements Medical Devices Regulations require us to track the location of a
8. 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 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz 40 66 MHz to 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 450P is used exceeds the applicable RF compliance level see above the SAM 450P should be observed to verify that it is operating normally If abnormal operation is observed additional measures may be n
9. 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 center and the other pad on the child s BARE back in the center of the ribcage as shown in Method a N 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
10. 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 analyze 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 authorized 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 authorized distributor or HeartSine Technologies Technical Support at support HeartSine com 26 Warranty exclusion HeartSine or its authorized distributors are not obliged to replace or repair under warranty if one or more of the following conditions apply The device has been opened Unauthorized 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 ha
11. support AED advanced life support or a physician authorized emergency medical response training program Caution US Federal law restricts this device to sale by or on the order of a physician Warnings and Cautions A Warning Patients suitable for treatment The SAM 450P has been designed to work on unconscious unresponsive patients If the patient is responsive or conscious do not use the SAM 450P to provide treatment The SAM 450P uses an interchangeable battery and electrode pack called Pad Pak The SAM 450P in combination with an adult Pad Pak is suitable for use on patients of over 55 Ibs 25 kg 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 If you treat a pediatric patient with an adult Pad Pak ignore any voice prompts regarding the rate of the cardiopulmonary resuscitation CPR The CPR Rate 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 450P 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
12. C lt 3 y 2 Ro S gl c w x Zz BK N 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 dd 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 Serial number e g yyG01234567 where yy year of manufacture Indications for Use Indications for use The HeartSine samaritan PAD 450P is indicated for use on victims of cardiac arrest who are exhibiting the following signs e Unconscious e Not breathing e Without circulation The samaritan PAD 450P 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 SAM 450P 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 450P to provide treatment Intended users The SAM 450P is intended for use by personnel who have been trained in its operation Users should have received training in basic life
13. b on the Pad Pak If you have opened the electrode drawer you may have to replace your Pad Pak Turn the SAM 450P on only 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 Turn off the SAM 450P by pressing on the front panel Check the status indicator see SAM 450P 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 16 Preparation 6 Place the SAM 450P in its supplied soft carry case Store the SAM 450P 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 32 F to 122 F temperature 0 C to 50 C 5 to 95 non condensing Relative humidity 1 Notice HeartSine recommends that you keep a spare Pad Pak with your SAM 450P You can store it in the rear section of the soft carry case 7 Complete the Registration and Warranty Card and return it to your authorized or HeartSine Technologies directly see Tracking Requirements on page 23 Preparation checklist o oO oOo oF oO Oo Step 1 Check the Pad Pak expiration date Step 2 Install the Pad Pak Step 3 Check for a successful completion of the self test routine Step 4 Turn on to
14. cator flashing red If the status indicator is flashing red or if the device is emitting a beep check the expiration date on your Pad Pak see Preparation on page 14 If the expiration date has not been passed turn on the SAM 450P 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 authorized 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 prepare the spare Pad Pak for use and be prepared to swap it quickly Order a new Pad Pak as soon as possible This message does not indicate a fault 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 analyze and deliver a shock if required If you hear this message contact HeartSine Technologies technical support Alternatively use the HeartSine Saver EVO software to clear the memory refer to the Saver EVO user manual 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
15. check operation Step 5 Turn off Step 6 Store the SAM 450P correctly Step 7 Register your SAM 450P Step 8 Create a service schedule see Service and Maintenance on page 22 Using the SAM 450P When to use The SAM 450P is indicated for use on victims of sudden cardiac arrest who are exhibiting the following signs Unconscious Not breathing Without circulation The SAM 450P has been designed to work on unconscious unresponsive patients If the patient is responsive or conscious do not use the SAM 450P to provide treatment When used with an adult Pad Pak the SAM 450P is suitable for use on patients of over 55 Ibs 25 kg 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 450P Refer to the separate Emergency User Guide During use the SAM 450P will give extensive voice prompts and LED indications to guide a user See List of Voice Prompts on page 41 and the LED sequence shown in the table on page 34 Notice The SAM 450P aborts 1 a ready to shock condition once a non shockable rhythm is detected 17 Using the SAM 450P After use 1 Turn off the SAM 450P by pressing on the front panel 2 Remove the electrode pads fro
16. e Further Information Use of this manual It is important that you read this manual carefully before using the SAM 450P This manual is presented in support of any training you may have received If you have any questions contact your authorized distributor or HeartSine Technologies directly support heartsine com 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 SAM 450P 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 450P is a self contained device Do not use any unauthorized accessories with it The SAM 450P 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 authorized distributor Please follow the A
17. ecessary such as re orienting or relocating the SAM 450P 39 The SAM 450P is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the SAM 450P can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the SAM 450P as recommended below according to the maximum output power of the communications equipment Not applicable 0 12 3 z For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters 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 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz 40 66 MHz to 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 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz to decrease the likelihood that mobile portable communications equipment could cause interference if it i
18. fter use on page 18 Compliance with local regulations Check with the relevant local government health department for information about any requirements associated with ownership and use of a defibrillator in the region where it is to be used Introduction The SAM 450P The SAM 450P is a semi automatic external defibrillator designed to quickly deliver a defibrillation shock to victims of sudden cardiac arrest SCA The SAM 450P is designed to operate in accordance with the joint American Heart Association AHA and European Resuscitation Council ERC 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 the patient is experiencing symptoms of a heart attack chest pain pressure shortness of breath tight feeling in the chest or elsewhere in the body
19. ge lithium manganese dioxide LiMnO 18V gt 60 shocks at 200 J or 6 hours of continuous monitoring gt 10 shocks at 200 J See the expiration date on the Pad Pak Single use pre attached combined ECG sensor defibrillation pad Adult anterior lateral Pediatric electrodes anterior posterior or anterior lateral 15 5 inch 100 cm 3 25 ft 1 m See the expiration date on the Pad Pak Patient analysis system Method Sensitivity Specificity 28 Evaluates the patients ECG signal quality electrode contact integrity and patient impedance to determine if defibrillation is required Meets IEC 60601 2 4 User Interface Visual prompts Audible prompts Languages Controls Attach pads stand clear perform CPR shock now status indicator CPR Rate Advisor indicator Extensive voice prompts guide the user through the operation sequence see List of Voice Prompts on page 41 Contact your HeartSine authorized 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 Optimized biphasic waveform compensates energy slope and envelope for patient impedance Pre confi
20. gured factory settings for escalating energy are Version AHA ERC 2010 Adult Shock 1 150J Shock 2 150J Shock 3 200J Pediatric Shock 1 50J Shock 2 50J Shock 3 50J 29 Technical Data Event recording Type Memory Event 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 MHz 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 450P delivers a Self Compensating Output Pulse Envelope SCOPE biphasic waveform This waveform automatically optimizes the waveform pulse envelope amplitude slope and duration for a wide range of patient impedances from 20 ohms to 230 ohms The delivered waveform to the patient is an optimized impedance compensated biphasic truncated exponential waveform that incorporates an escalating energy protocol of 150 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 a
21. ll medical devices sold It is important that you complete the Registration and Warranty Card with your details and return it to your authorized 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 450P 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 450P contact us with the updated information 23 Data Management The HeartSine Saver EVO software is an optional accessory Contact your authorized distributor or HeartSine Technologies directly about the after use data management service 1 Connect the custom USB cable supplied separately to the SAM 450P see illustration below 24 2 Connect the USB cable to a PC 3 Launch the HeartSine Saver EVO utility Notice The SAM 450P should 1 only be connected to an IEC60950 PC Caution You cannot defibrillate while the SAM 450P is connected to a PC For further information on this optional accessory contact your authorized distributor or HeartSine Technologies directly Troubleshooting Status indi
22. lways a constant 0 4 ms for all patient impedances The specific SCOPE waveform characteristics for a 150 joules pulse are listed opposite Waveform Waveform Resistance Voltages volts Duration ms ohms Tilt 25 1640 63 1 3 3 50 1650 52 7 4 5 4 5 T9 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 eee Arrhythmia analysis algorithm Voltages Duration The SAM 450P uses the HeartSine A Tans Yona s samaritan ECG arrhythmia analysis algorithm This algorithm will evaluate the patient s ECG to ascertain if a therapeutic 475 514 55 6 78 54 shock is appropriate If a shock is required 30 51 3 671 50 4 88 6 the SAM 450P will charge and advise the 75 52 1 751 4714 10 6 6 user to press the shock button If no shock 100 51 8 813 44 3 10 8 68 is advised the device will pause to allow 125 52 4 858 41 4 11 5 7 3 the user to deliver CPR Example Pediatric Pak waveform parameters The SAM 450P 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 Instit
23. m 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 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 side of the Pad Pak The Pad Pak will slide forward see the illustration below Do not dispose of the SAM 450P or Pad Pak in the normal waste Dispose of it at an appropriate recycling facility according to local requirements Alternatively return it to your authorized distributor for disposal or replacement Check the SAM 450P 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 450P 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 450P with abrasive materials cleaners or solvents 5 Check the SAM 450P for damage If the SAM 450P is damaged replace it immediately 6 Install a new Pad Pak Before installing check the Pad Pak expiration 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
24. mel Begin CPR Compression rate is slower than 90 per minute Push Faster Compression rate is between 90 and 99 per minute Metronome only Compression rate is between 100 and 120 per minute Good Speed Compression rate is between 121 and 130 per minute Metronome only Compression rate is faster than 130 per minute Push Slower 34 Pediatric restriction Use of the CPR Rate Advisor function must be restricted to adult patients only Chest compression techniques differ for the different ages and sizes of pediatric patients up to eight years old For younger pediatric patients rescuers should compress the lower half of the sternum but not compress over the xiphoid For patients at the upper end of the pediatric range adult style compressions should be performed CPR Rate Advisor is currently configured only to advise compressions at a rate suitable for adult patients over eight years old weighing more than 55lbs 25kg Electrode placement may also differ in pediatric 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 Rate Advisor in determining which electrode placements are being used and therefore electrodes must be placed anterior lateral for CPR Rate Advisor to function correctl
25. nds in middle of chest Press directly down on the chest in time with the metronome Remain calm Voice messages not provided when pediatric Pad Pak is installed 41 43 Authorized Distributor www heartsine com info heartsine com EMEA APAC US Americas HeartSine Technologies Ltd HeartSine Technologies Inc 203 Airport Road West 121 Friends Lane Suite 400 Belfast Northern Ireland BT3 9ED Newtown PA 18940 Tel 1 215 860 8100 Tel 44 28 9093 9400 Toll Free 1 866 478 7463 Ho41 019 100 2 Fax 4 4 28 9093 9401 Fax 1 215 860 8192 English US
26. s 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 8 0 in x 7 25 in x 1 9 in 20 cm x 18 4 cm x 4 8 cm 2 4 Ibs 1 1 kg 32 F to 122 F 0 C to 50 C 32 F to 122 F 0 C to 50 C 14 F to 122 F 10 C to 50 C for up to two days If the device has been stored below 32 F 0 C it should be returned to an ambient temperature of between 32 F to 122 F 0 C to 50 C for at least 24 hours before use 5 to 95 non condensing IEC 60529 EN 60529 IP56 0 feet to 15 000 feet 0 meters to 4575 meters 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 44 Ibs 0 2 kg Disposable single use combined battery and defibrillation electrode cartrid
27. s 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 Some of the voice prompts used by the SAM 450P are listed below Read the voice prompts before you use the SAM 450P so you are familiar with the types of instructions given Note This is not a complete list of voice prompts just the ones you will encounter most often 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 CPR Rate Advisor Push faster Push slower Good speed 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 ha
28. the pouch that seals defibrillation pads has been broken or compromised in any way If you suspect that the Pad Pak is damaged you must replace it immediately 1 Notice Susceptibility to electromagnetic interference To safeguard against interference you must operate the SAM 450P at least 6 feet 2 m away from all radio frequency devices Alternatively switch off the equipment causing the electromagnetic interference Temperature range for operation The SAM 450P with its battery pads and electrodes is designed to operate in the temperature range of 32 F to 122 F 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 450P in water or any type of fluid Contact with fluids may seriously damage the device or cause fire or a shock hazard i 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 32 F to 122 F 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 devic
29. to be provided Alternatively contact your local government health department for information on certified training organizations in your region 12 CPR metronome During CPR the SAM 450P 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 450P Overview Attach pads indicator Status indicator When the indicator is flashing green the SAM 450P 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 to deliver a therapeutic shock Lights indicate when device is ready to shoc Stand clear indicator Do not touch the patient when the action arrows around this icon are flashing The SAM 450P may be analyzing the patient s heart rhythm or about to charge preparing to deliver a shock Action arrows On Off button Press this button to turn the device on or off Safe to touch indicator Speaker It is safe to touch the patient when the action arrows around this icon are flashing Electrode trawe Green tab Pull tab to access electrodes 13 Preparation Unpacking Checks before putting into service Check that the contents include the User 1
30. turer s declarati magnetic immunity The SAM 450P is intended for use in the electromagnetic environment specified below The customer or user of the SAM 450P must assure that it is used in such an environment Immunity test pa soit oa Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the SAM 450P 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 150 kHz to 80 MHz applicable Not applicable in ISM bands Radiated RE 10 V m b be d 1 2 P 80 MHz to 800 MHz IEC EN 61000 4 3 80 MHz to 2 5 GHz to2 5GHz d 2 3 JP 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 meters 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 may occur in the vicinity of equipment marked with the following symbol C Note 1 At 80 MHz and 800 MHz the higher
31. ute of Technology MIT NST database The SAM 450P ECG arrhythmia analysis algorithm s sensitivity and specificity meet the requirements of IEC60601 2 4 32 The SAM 450P ECG arrhythmia analysis algorithm performance is summarized in the table below Rhythm Class Total Blocks Required seconds Performance 90 Lower Results Confidence Shockable Rhythm Limit a a e 14538 Sensitivity gt 90 97 03 95 31 Shockable Rhythm ee Ventricular Tachycardia VT 2321 Sensitivity gt 75 92 55 80 52 Non shockableRhythm 301177 Specificity gt 95 98 30 95 02 Combined Non Shockable Rhythms 33 Technical Data CPR Rate Advisor The SAM 450P utilizes the ICG Impedance Cardiogram capability to assess the rate of chest compressions being applied during cardiopulmonary resuscitation CPR Based on the measured rate the SAM 450P provides verbal feedback to the user to push faster push slower or continue to provide good speed in accordance with the current AHA resuscitation guidelines target CPR rate of at least 100 CPM The SAM 450P also uses the ICG to provide CPR Rate Advisor feedback in the form of a colored traffic light green amber red configuration LED array as shown in the table below The LED array is accompanied by text on the device s top cover membrane to indicate when the operator s compressions are too slow or too fast me cara
32. y For these reasons CPR Rate Advisor is disabled when a Pediatric Pak is used in the SAM 450P Notice The ECG readings used to determine if the patient requires a defibrillation shock are not affected by the electrode positions selected in pediatric patients ignore the CPR Rate Advisor feedback prompts provided CPR Rate Warning If a pediatric patient is treated with an adult Pad Pak you must Advisor is currently only intended to provide feedback on adult patients 35 Technical Data Guidance and manufacturer s declarati agnetic emissions The SAM 450P is intended for use in the electromagnetic environment specified below The customer or user of the SAM 450P must assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance The SAM 450P 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 EN 61000 3 2 PR 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 s declaration elec gnetic immunity
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