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HeartSine samaritan PAD 450P, Руководство пользователя

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User Manual

samaritan

®

 PAD 450P 
SAM 450P

Содержание samaritan PAD 450P

Страница 1: ...User Manual samaritan PAD 450P SAM 450P ...

Страница 2: ...hecks before putting into service 14 Preparation checklist 16 Using the SAM 450P 17 When to use 17 Using the SAM 450P 17 After use 18 Pediatric Pak 20 Service and Maintenance 22 Tracking Requirements 23 Data Management 24 Troubleshooting 25 Status indicator flashing red 25 Low battery warning 25 Memory full warning 25 Audible warnings 25 Device service required 26 Sources of support 26 Warranty ex...

Страница 3: ...expose to high heat or open flame Do not incinerate Does not contain natural rubber latex Non sterile Recyclable Non rechargeable battery Do not short circuit battery Do not crush battery Temperature limitation as indicated Use by yyyy mm dd Dispose of in accordance with country requirements 3XN6 Automated External Defibrillator With respect to electrical shock fire and mechanical hazards only in ...

Страница 4: ...se on children between 1 and 8 years of age or up to 55 lbs 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 support AED advan...

Страница 5: ...illator 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 deliver...

Страница 6: ... 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 t...

Страница 7: ...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 protec...

Страница 8: ... 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 not...

Страница 9: ...e 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 After use on page 18 Compliance with local regulations Check with the rel...

Страница 10: ...pends 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 the patient is experiencing symptoms of a heart attack chest pain pressure shortness of breath tight feeling in t...

Страница 11: ...rdiogram 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 audible and visual feedback to give the responder instruction on CPR rate Warning The CPR Rate Advisor function is intended for use on adult pat...

Страница 12: ... 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 to be provided Alternatively contact your local government health department for information on certified training organizations in your region CPR metro...

Страница 13: ...r It is safe to touch the patient when the action arrows around this icon are flashing Action arrows CPR Rate Advisor icon Speaker Pediatric ready icon 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 Data port Shock button Press this button to...

Страница 14: ...1 gray colored Pad Pak for use with adults and a pink colored Pediatric Pak for use with children see the illustration below 1 A third version is also available specifically for airlines Checks before putting into service 1 Check the expiration date year month day on the rear of the Pad Pak see the illustration below If the expiration date has passed you must replace the Pad Pak Preparation Pediat...

Страница 15: ...r 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 tab 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 y...

Страница 16: ... 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 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 ...

Страница 17: ...eight 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...

Страница 18: ...ide 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 4 Check the SAM 450P for dirt or contamination If necessary clean it using a soft cloth dampened by one of the following Soapy water ...

Страница 19: ...or 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 ...

Страница 20: ...rs old who are Unconscious Not breathing Without circulation 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 Method a ...

Страница 21: ...f their chest is large enough OR if trauma does not allow for the placement as shown in Method a 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 y...

Страница 22: ...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 If the device shows any signs of physical damage contact your authorized distributor or HeartSine Technologies directly Check the expiration date of the SAM 450P Pad Pak see Preparation on page 14 for the location of the date If the date has expir...

Страница 23: ...ne 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 addr...

Страница 24: ...e supplied separately to the SAM 450P see illustration below 2 Connect the USB cable to a PC 3 Launch the HeartSine Saver EVO utility Notice The SAM 450P should 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 Data Mana...

Страница 25: ...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 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 S...

Страница 26: ...Technologies Technical Support at support HeartSine com 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 bee...

Страница 27: ...or 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 Relative humidity 5 to 95 non condensing Enclosure IEC 60529 EN 60529 IP56 Altitude 0 feet to 15 000 feet 0 meters to 4575 meters Shock MIL STD 810F Method 516 5 Procedure 1 40G s Vibration MIL STD 810F Method 514 5 Pro...

Страница 28: ...d Pak Electrode type Single use pre attached combined ECG sensor defibrillation pad Electrode placement Adult anterior lateral Pediatric electrodes anterior posterior or anterior lateral Electrode active area 15 5 inch2 100 cm2 Electrode cable length 3 25 ft 1 m Electrode shelf life See the expiration date on the Pad Pak Patient analysis system Method Evaluates the patient s ECG signal quality ele...

Страница 29: ...r performance Times to shock delivery fresh battery or after 6 shocks Charging time Typically 150J in 8 sec 200 J in 12 sec Following CPR Typically 8 seconds Impedance range 20 Ω to 230 Ω Therapeutic shock Waveform SCOPE Self Compensating Output Pulse Envelope biphasic escalating waveform Optimized biphasic waveform compensates energy slope and envelope for patient impedance Energy Pre configured ...

Страница 30: ...nnected 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 immunity IEC61000 4 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 Technical Data ...

Страница 31: ...omatically 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 2000 1 0 V1 V3 T3 T2 T1 1 2 3 4 5 6 7 8 9 1000 500 0 500 1000 Resistance ohms Waveform V...

Страница 32: ...scertain if a therapeutic shock is appropriate If a shock is required the SAM 450P will charge and advise the user to press the shock button If no shock is advised the device will pause to allow the user to deliver CPR The SAM 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 ...

Страница 33: ...al Blocks seconds Required Performance Results 90 Lower Confidence Limit Shockable Rhythm Ventricular Fibrillation VF 14538 Sensitivity 90 97 03 95 31 Shockable Rhythm Ventricular Tachycardia VT 2321 Sensitivity 75 92 55 80 52 Non Shockable Rhythm Combined Non Shockable Rhythms 301177 Specificity 95 98 30 95 02 ...

Страница 34: ...e 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 Description Audio message LED sequence N A Begin CPR Compression rate is slower than 90 per minute Push Faster Compression ...

Страница 35: ...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...

Страница 36: ...e 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 Class B The device is suitable for use in all establishments including domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purpose...

Страница 37: ...lectrical 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 1kV differential mode 2 kV common mode Not Applicable Not Applicable Voltage dips short interruptions and voltage variations on power supply input lines IEC EN 61000 4 11 5 Ut 95 dip in Ut for 0 5 cycle 40 Ut 60 dip in Ut for 5 cycles 70 Ut 30 ...

Страница 38: ...ble Not applicable 10 V m 80 MHz to 2 5 GHz 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 Not applicable Not applicable d 1 2 P 80 MHz to 800 MHz d 2 3 P 800 MHz to 2 5 GHz Where ...

Страница 39: ...le 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 a...

Страница 40: ...or 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 app...

Страница 41: ...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 shoc...

Страница 42: ...42 Notes ...

Страница 43: ...43 ...

Страница 44: ...ies Inc 121 Friends Lane Suite 400 Newtown PA 18940 Tel 1 215 860 8100 Toll Free 1 866 478 7463 Fax 1 215 860 8192 EMEA APAC HeartSine Technologies Ltd 203 Airport Road West Belfast Northern Ireland BT3 9ED Tel 44 28 9093 9400 Fax 44 28 9093 9401 Authorized Distributor H041 019 100 2 English US ...

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