HeartSine samaritan SAM 350P User Manual
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HeartSine samaritan SAM 350P User Manual

Pad (automatic defibrillator)
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USER MANUAL
HeartSine
samaritan
PAD
®
®
SAM 350P Semi-Automatic Defibrillator
SAM 360P Fully Automatic Defibrillator
SAM 450P Semi-Automatic Defibrillator

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Summary of Contents for HeartSine samaritan SAM 350P

  • Page 1 USER MANUAL HeartSine samaritan ® ® SAM 350P Semi-Automatic Defibrillator SAM 360P Fully Automatic Defibrillator SAM 450P Semi-Automatic Defibrillator...
  • Page 2 ® PAD. 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. CAUTION: U.S. Federal law restricts this device to sale by or on the order of a physician.

  • Page 3: Table Of Contents

    Contents SAM 350P 360P 450P User Manual Indications for Use ........2 Using the samaritan PAD ......16 Pediatric-Pak ..........21 Contraindications for use ......2 Caution ............2 Treating Small Children and Infants ..21 Warnings and Precautions ......3 Electrode Placement ........21 Overview ............6 After Using the samaritan PAD ....

  • Page 4: Indications For Use

    Indications for Use The HeartSine samaritan PAD SAM 350P (SAM 350P), HeartSine samaritan PAD SAM 360P (SAM 360P) and HeartSine samaritan PAD SAM 450P (SAM 450P) all have the identical indications for use. Each is indicated for use on victims of cardiac arrest who are exhibiting the the following signs: •...

  • Page 5: Warnings And Precautions

    Warnings and Precautions WARNINGS Patients Suitable for Treatment Risk of Electric Shock The samaritan PAD has been designed to work The samaritan PAD delivers therapeutic electrical on unconscious, nonresponsive patients. If the shocks that can cause serious harm to either patient is responsive or conscious, do not use the users or bystanders.
  • Page 6 Warnings and Precautions continued WARNINGS PRECAUTIONS Fully Automatic Defibrillator (SAM 360P) Correct Placement of Electrode Pads The SAM 360P is a fully automatic defibrillator. Proper placement of the samaritan PAD electrode When required, it will deliver a shock to the patient pads is critical.
  • Page 7 Ingress Protection Regular Maintenance The samaritan PAD has an IP56 rating against Check the device periodically. See Service and dust and sprays of water. However, the IP56 rating Maintenance on page 27. does not cover the immersion of any part of the Correct Disposal of the Device samaritan PAD in water or any type of fluid.

  • Page 8: Overview

    Overview Sudden Cardiac Arrest sinus rhythm by means of an electric shock across Sudden cardiac arrest (SCA) is a condition in which the heart. This treatment is called defibrillation. the heart suddenly stops pumping blood effectively Ventricular Tachycardia due to a malfunction of the heart’s electrical system. Ventricular tachycardia (VT) is a type of tachycardia Often victims of SCA have no prior warning signs (rapid heartbeat) that arises from improper...
  • Page 9 The samaritan PAD uses the HeartSine samaritan ECG arrhythmia analysis algorithm. This algorithm will evaluate the patient’s ECG to ascertain if a therapeutic shock is appropriate. If a shock is required, the samaritan PAD will charge and advise the user to press the shock button (SAM 350P/450P) or will automatically deliver a shock (SAM 360P).

  • Page 10: Introduction

    Introduction This manual provides instructions for the following The SAM 350P is a semi-automatic defibrillator, the models of the HeartSine samaritan PAD: SAM 360P is a fully automatic defibrillator, and the SAM 450P is a semi-automatic defibrillator with samaritan PAD 350P (SAM 350P) integrated CPR Rate Advisor ™...

  • Page 11: Recommended Training

    The SAM 450P uses emergency medical response training program. impedance cardiogram measurements to analyze HeartSine Technologies also recommends that the speed of compressions and provide the user this training be kept up to date by regular...

  • Page 12: Sam 350P Layout

    Introduction continued SAM 350P Layout Attach Pads Icon/Action Arrows Status Indicator Data Port Attach the electrode pads to the The SAM 350P is ready for Plug the custom USB cable patient’s bare chest as indicated use when this indicator is into this port to download when the action arrows are flashing.

  • Page 13: Sam 360P Layout

    SAM 360P Layout Attach Pads Icon/Action Arrows Status Indicator Data Port Attach the electrode pads to the The SAM 360P is ready for Plug the custom USB cable patient’s bare chest as indicated use when this indicator is into this port to download when the action arrows are flashing.

  • Page 14: Sam 450P Layout

    Introduction continued SAM 450P Layout Attach Pads Icon/Action Arrows Status Indicator Data Port Attach the electrode pads to the The SAM 450P is ready for Plug the custom USB cable patient’s bare chest as indicated use when this indicator is into this port to download when the action arrows are flashing.

  • Page 15: Set-Up

    Set-up Unpacking Verify that the contents include the samaritan PAD, carry case, Pad-Pak, User Manual, Warranty Statement and Warranty Card. Pad-Pak A Pad-Pak is a single-use removable cartridge that includes the battery and electrode pads in a single unit. The Pad-Pak is available in two versions: 1.

  • Page 16: Putting The Samaritan Pad Into Service

    Pad-Pak to PRECAUTION: Do NOT pull the green tab on HeartSine Technologies. the Pad-Pak at this time. If you have pulled the tab 3. Place the samaritan PAD face up on a flat surface...

  • Page 17: Preparation Checklist

    8. Register online, or complete the Warranty Card ▫ Step 7. Create a service schedule. and return it to your Authorized Distributor or (See Service and Maintenance on HeartSine Technologies directly (see Tracking page 27.) Requirements on page 26). 9. Create a service schedule (see Service and...

  • Page 18: Using The Samaritan Pad

    Using the samaritan PAD Using the samaritan PAD 2. If the patient is non-responsive, shake the Follow these steps to use your AED, which will patient by the shoulders while speaking loudly. provide you with step-by-step voice prompts. If the patient becomes responsive, do not use For a full list of voice prompts for your device see the AED.
  • Page 19 4. Call for medical assistance. 7. Press the On/Off Button to turn on the AED. 5. Retrieve the AED, asking others nearby to do so. TURN ON 6. While waiting for the AED, begin CPR, pushing THE AED hard and fast at a rate of between 100 and 120 compressions per minute (cpm) and a depth of 5 to 6 cm.
  • Page 20 Using the samaritan PAD continued 9. Remove clothing from patient’s chest to expose 12. Tear open the pouch to remove the electrode pads. bare skin, removing any metal (bras or jewelry) OPEN where possible from the pad placement area. ELECTRODE BARE THE POUCH CHEST...
  • Page 21 13. Peel the liner from each electrode pad and 14. If you again hear the prompt to apply pads apply each electrode pad firmly to the patient’s firmly to patient’s bare chest, check that the: bare chest. For a patient over 8 years of age or •...
  • Page 22 Using the samaritan PAD continued 16. When advised that a shockable rhythm is detected, stand clear of patient as directed. When advised to do so, press the orange shock button (SAM 350P/SAM 450P) to deliver a shock, or if using a SAM 360P, the AED will automatically deliver the shock after a verbal 3, 2, 1 countdown.

  • Page 23: Pediatric-Pak

    Pediatric-Pak Treating Small Children and Infants ANTERIOR-POSTERIOR PLACEMENT The Pediatric-Pak is intended to provide therapy for If a child’s chest is small it may be necessary to pediatric (child) victims of SCA between the ages of place one electrode pad in the centre of the child’s 1 and 8 years old or weighing less than BARE chest (anterior), and the other electrode pad 55 lb/25 kg who are:...
  • Page 24 Pediatric-Pak continued ANTERIOR-LATERAL PLACEMENT If a child’s chest is large enough to permit a 1 in/2.5 cm gap between the electrode pads, OR if trauma does not allow for placement on the back, the pads can be placed according to the adult anterior-lateral placement.

  • Page 25: After Using The Samaritan Pad

    Pad-Pak, check the expiration date (see Set-up on page 14). After installation, confirm that the Status Indicator is blinking green. 6. Report the use of the samaritan PAD to HeartSine Technologies or your Authorized Distributor. (See back cover for contact details.) Figure 7. Removing the Pad-Pak...

  • Page 26: Downloading And Submitting Event Information

    After using the samaritan PAD continued Downloading and Submitting Event Information The optional HeartSine Saver EVO™ software can be downloaded at no charge from: http://heartsine.com/support/upload-saver-evo/ This software lets you manage the events in which your samaritan PAD was used. You can provide this data to a patient’s doctor, and/or use it to...

  • Page 27: Disposal

    4. Follow the instructions provided in the Saver EVO manual to save or erase the event data on your samaritan PAD. 5. Upload the Saver EVO file on the HeartSine Technologies site. For further information on managing the event data on your samaritan PAD, contact your Authorized Distributor or HeartSine Technologies directly.

  • Page 28: Tracking

    Or by completing the samaritan PAD Warranty Card and returning it to your Authorized Distributor or HeartSine Technologies directly. As an alternative to the card and on-line registration tool, you may send an email to: heartsinesupport@stryker.com The email should contain the following information: •...

  • Page 29: Service And Maintenance

    ▫ If you hear a warning message when you turn Testing with Simulators and Manikins on your samaritan PAD or if, for any reason, you HeartSine devices cannot be tested using industry- suspect that your samaritan PAD is not working standard simulators and manikins. Therefore, properly, consult Troubleshooting in Appendix B.

  • Page 30: Appendices

    Appendices...

  • Page 31: Appendix A Symbols

    APPENDIX A Symbols Symbols Used in this Manual Do not crush battery WARNING: Risk of death or serious injury Temperature limitation as indicated PRECAUTION: Risk of injury Expiration date for Pad-Pak; YYYY-MM-DD Symbols Used on the samaritan PAD Dispose of in accordance with country requirements On/Off Automated External Defibrillator...

  • Page 32: Appendix B Troubleshooting

    ECG data or events. However, the device can still analyze and deliver a shock if required. Contact HeartSine Technologies Technical Support for guidance on how to clear the memory. Three Rapid Beeps When Device Is...
  • Page 33 If you hear this message during use, seek an alternative defibrillator immediately. Do not attempt to service the device as no modification of this equipment is possible. Contact HeartSine Technologies or your Authorized Distributor immediately. “You have pressed the off You have pressed the On/Off button while the AED is being button”...
  • Page 34 Troubleshooting continued Obtaining Support If you have completed the troubleshooting steps and find the device is still not working correctly, contact your Authorized Distributor or HeartSine Technologies Technical Support at: heartsinesupport@stryker.com Warranty Exclusion HeartSine Technologies or its Authorized Distributors are not obliged to replace or repair...

  • Page 35: Appendix C Technical Data

    APPENDIX C Technical Data Physical Specifications (with Pad-Pak installed) Size: 8.0 in x 7.25 in x 1.9 in/20 cm x 18.4 cm x 4.8 cm Weight: 2.4 lb/1.1 kg Environmental Specifications Operating temperature: 32°F to 122°F/0°C to 50°C Standby temperature: 32°F to 122°F/0°C to 50°C Transport temperature: 14°F to 122°F/-10°C to 50°C for up to two days.
  • Page 36 Extensive voice prompts guide the user through the operation sequence (see Voice Prompts in Appendix D) Languages: samaritan PAD is available in English and Spanish. Contact your HeartSine Authorized Distributor. Controls: On/Off Button (all models), Shock Button (SAM 350P and 450P only) and...
  • Page 37 Defibrillator Performance Charging time: Typically 150J in < 8 seconds, 200J in < 12 seconds Time to shock delivery following CPR: SAM 350P: Typically 8 seconds SAM 360P: Typically 19 seconds SAM 450P: Typically 12 seconds Impedance range: 20 Ω to 230 Ω Therapeutic Shock Waveform: SCOPE...
  • Page 38 APPENDIX C Technical Data continued SCOPE Biphasic Waveform The samaritan PAD delivers a Self-Compensating Output Pulse Envelope (SCOPE) biphasic waveform which 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.
  • Page 39 Table 3. Pediatric-Pak Waveform Specification Waveform Waveform Voltages Duration Resistance Energy (volts) (ms) (ohms) (joules) Tilt 47.5 55.6 51.3 50.4 52.1 47.1 51.8 44.3 10.8 52.4 41.4 11.5 NOTE: Table contains example Pediatric-Pak waveform parameters. Motion Detection Algorithm (SAM 360P only) The SAM 360P uses the samaritan PAD ICG analysis to detect chest compression artefact and other forms of motion in order to play a verbal warning to stop CPR or other motion.
  • Page 40 APPENDIX C Technical Data continued Arrhythmia Analysis Algorithm The samaritan PAD uses its ECG arrhythmia analysis algorithm to evaluate the patient’s ECG to determine if a therapeutic shock is appropriate. If a shock is required, the samaritan PAD will charge and advise the user to stand clear and to press the shock button (SAM 350P and 450P) or automatically shock the patient after a verbal 3, 2, 1 countdown (SAM 360P).
  • Page 41 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”...
  • Page 42 APPENDIX C Technical Data continued Pediatric Restriction Use of the CPR Rate Advisor function is 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.
  • Page 43 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The samaritan PAD is intended for use in the electromagnetic environment specified in Table 6. The customer or the user of the samaritan PAD should assure that it is used in such an environment. Table 6.
  • Page 44 APPENDIX C Technical Data continued Table 7. Electromagnetic Immunity Immunity Test IEC 60601 Test Level Compliance Level Electrostatic discharge (ESD) ± 6 kV contact ± 6 kV contact IEC/EN 61000-4-2 ± 8 kV air ± 8 kV air Electrical fast transient/burst ±2kV for power supply lines Not Applicable IEC/EN 61000-4-4...
  • Page 45 Electromagnetic Environment – Guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Not Applicable Not Applicable Not Applicable Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
  • Page 46 APPENDIX C Technical Data continued 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.
  • Page 47 Recommended Separation Distances between Portable and Mobile RF Communication Equipment and the samaritan PAD The samaritan PAD is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the samaritan PAD can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the samaritan PAD as recommended in Table 8, according to the maximum output power of the communications equipment.
  • Page 48 APPENDIX C Technical Data continued 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;...

  • Page 49: Appendix D Voice Prompts

    APPENDIX D Voice Prompts Following are the voice prompts used by the samaritan PAD devices. Models using specific voice prompts are indicated. Read the voice prompts in advance of use to be familiar with the types of instructions given. For All Patients PROMPT SAM 350P SAM 360P...
  • Page 50 APPENDIX D Voice Prompts continued PROMPT SAM 350P SAM 360P SAM 450P 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 metronome”...
  • Page 51 1,2,3 The results from the preclinical laboratory testing performed on the HeartSine SAM 350P, SAM 360P and SAM 450P devices demonstrated appropriate electrical safety, electromagnetic compatibility, biocompatibility, mechanical integrity, and overall performance.

  • Page 52: Safety And Effectiveness Data

    APPENDIX E Safety and Effectiveness Data continued Two animal studies were conducted to determine whether the SCOPE waveform induces refibrillation or increases defibrillation thresholds (DFTs) if the pulse duration exceeds 20 ms. The first of these studies included 6 pigs and the delivery of 208 shocks, including 68 shocks with pulse durations greater than or equal to 20 ms;...
  • Page 53 This study compared two (2) impedance compensated biphasic waveforms: • HeartSine’s samaritan (SAM) (100-150-200 J energy protocol at the time based on the AHA guidelines then in effect) using the same SCOPE defibrillation waveform present in the SAM 350P, SAM 360P and SAM 450P;...
  • Page 54 . These data were not powered to demonstrate differences in return of spontaneous circulation or survival. This study was conducted on the HeartSine samaritan AED (cleared under 510(k) K023854) with the identical SCOPE waveform as used in the SAM 350P, SAM 360P and SAM 450P.
  • Page 55 Table 9: Summary of Successful Defibrillation Episodes with Both Devices HeartSine samaritan Philips HeartstreamXL (100-150-200J) (150-150-150J) Mean Probability that samaritan Success by Frequency Proportion Frequency Proportion Difference Better than Heartstream First Shock 0.582 0.642 -0.0598 0.0742 0.210 Second Shock 0.823 0.779...
  • Page 56 APPENDIX E Safety and Effectiveness Data continued were in ventricular tachycardia. Of these 334 patients, a shock was delivered in 322 patients. Of these 322 events, 220 (68.3%) events involved the SAM 300P device, 37 (11.5%) events involved the SAM 350P device, 2 (0.6%) events involved the SAM 360P device, no (0%) events involved the SAM 450P device and 63 (19.6%) events involved the SAM 500P device.
  • Page 57 (OR = 0.98 for a 1-year increase in age, p = 0.0324). Shock success and survival were similar among the HeartSine public access defibrillators studied in this analysis, which was anticipated since all the devices use the same defibrillation waveform, the same arrhythmia detection algorithm, and the same Pad-Pak electrode-battery packs.
  • Page 58 In summary, the postmarket data collected provides information on the real-world performance of the arrhythmia detection algorithm, waveform effectiveness and the overall usability of HeartSine’s public access defibrillators. First shock success and survival to admission were comparable in this study to rates reported in published literature .
  • Page 59 heartsine.com...
  • Page 60 . c o m For further information contact us at heartsinesupport@stryker.com or visit our website at heartsine.com. EMEA/APAC U.S./Americas The HeartSine SAM 450P is not available for sale outside of the U.S. or Japan.

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Samaritan sam 360pSamaritan sam 450p

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