HeartSine Samaritan PAD SAM 350P User Manual
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HeartSine Samaritan PAD SAM 350P User Manual

Semi-automatic defibrillator, fully automatic defibrillator, semi-automatic defibrillator with cpr rate advisor
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Summary of Contents for HeartSine Samaritan PAD SAM 350P

  • Page 1 EN-US HeartSine samaritan ® ® user manual SAM 350P semi-automatic defibrillator SAM 360P fully automatic defibrillator SAM 450P semi-automatic defibrillator with CPR Rate Advisor...

  • Page 2: Table Of Contents

    Safety and effectiveness data SAM 350P layout SAM 360P layout SAM 450P layout Set-up Unpacking Pad-Pak Putting the HeartSine samaritan PAD into service Preparation checklist Using the HeartSine samaritan PAD Pad-Pak and Pediatric-Pak Electrode placement Adult Pediatric After using the HeartSine samaritan PAD...
  • Page 3 Appendix F Limited warranty statement Use of This Manual It is important that you read this manual carefully before using your HeartSine samaritan 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.

  • 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 following signs: •...

  • Page 5: Warnings And Cautions

    Avoid explosive or flammable gases HeartSine samaritan PAD to provide treatment. The HeartSine samaritan PAD is safe to use with The HeartSine samaritan PAD uses an interchangeable oxygen mask delivery systems. However, to avoid the battery and electrode pack called Pad-Pak.
  • Page 6 12 in (30 cm) to any part of the HeartSine samaritan PAD including CAUTIONS cables specified by the manufacturer. Otherwise,...
  • Page 7 HeartSine samaritan PAD in water or any type of the region where it is to be used. fluid. Contact with fluids may seriously damage the device or cause fire or a shock hazard.

  • Page 8: Overview

    This treatment is called defibrillation. It is important to note that cardiac defibrillators, like the HeartSine samaritan PAD, will not administer a Ventricular tachycardia shock unless a lifesaving shock is required.

  • Page 9: Introduction

    About the HeartSine samaritan PAD WARNING The SAM 360P is a fully The HeartSine samaritan PAD family of AEDs is automatic defibrillator. When required, it will deliver designed to quickly deliver a defibrillation shock to a shock to the patient WITHOUT user intervention.

  • Page 10: Cpr Rate Advisor

    The HeartSine samaritan PAD is intended for use by Research has demonstrated that non-professional personnel who have been trained in its operation.

  • Page 11: Sam 350P Layout

    EN-US SAM 350P layout Data port Status indicator Remove blue cover and The SAM 350P is plug in the custom USB ready for use when data cable to download this indicator is flashing event data from the green. AED. Shock button Attach pads icon/ Press this button to action arrows...

  • Page 12: Sam 360P Layout

    Introduction SAM 360P layout Data port Status indicator Remove blue cover and The SAM 360P is plug in the custom USB ready for use when data cable to download this indicator is event data from the flashing green. AED. Attach pads icon/ Shock icon action arrows Flashes to indicate...

  • Page 13: Sam 450P Layout

    EN-US SAM 450P layout Data port Status indicator Remove blue cover and plug in the The SAM 450P is custom USB data cable to download ready for use when event data from the AED. this indicator is flashing green. Attach pads icon/ action Shock button arrows Press this button to...

  • Page 14: Set-Up

    Set-up Unpacking Verify that the contents include the HeartSine samaritan PAD, carry case, Pad-Pak, user manual and warranty registration 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 15: Putting The Heartsine Samaritan Pad Into Service

    Pad-Pak at this time. If you have pulled the tab 2. Unpack the Pad-Pak and retain the packaging in and opened the electrode drawer, you may need to case you need to return the Pad-Pak to HeartSine replace your Pad-Pak. Technologies.

  • Page 16: Preparation Checklist

    7. Place the HeartSine samaritan PAD in its supplied soft carry case. Store the HeartSine samaritan ¨ Step 3. Turn on the HeartSine samaritan PAD to PAD where it will be seen and heard in an check operation.

  • Page 17: Using The Heartsine Samaritan Pad

    For a full list of voice prompts for your device see Voice prompts in Appendix D. CAUTION Once a non-shockable rhythm is detected, the HeartSine samaritan PAD will end its ready to shock condition if it had previously decided to shock. 1. REMOVE DANGER If necessary, move the patient to a safe location, or remove any source of danger.
  • Page 18 Using the HeartSine samaritan PAD 4. CALL FOR MEDICAL ASSISTANCE 5. RETRIEVE THE AED Ask others nearby to do so. 6. PERFORM CPR While waiting for the AED, begin CPR, pushing hard and fast at a rate of between 100 and 120 compressions per minute (cpm) and a depth of 2 to 2.4 in (5 to 6 cm).
  • Page 19 EN-US 9. BARE THE CHEST AREA Remove clothing from patient’s chest to expose bare skin, removing any metal (bras or jewelry) where possible from the pad placement area. 10. DRY THE PATIENT’S CHEST Dry the patient’s chest if wet or clammy, and if a lot of chest hair is present, shave the patient’s chest where the electrodes will be placed.
  • Page 20 Using the HeartSine samaritan PAD 13. PLACE THE ELECTRODE PADS Peel the liner from each electrode pad and apply each electrode pad firmly to the patient’s bare chest. For a patient over 8 years of age or weighing over 55 lb (25 kg), place one electrode pad horizontally on the right chest, and the other vertically on the left rib cage.
  • Page 21 EN-US 16. STAND CLEAR WHEN ADVISED 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 22: Pad-Pak And Pediatric-Pak

    Table 2 below. is opened or damaged. This may result in the It is recommended that the HeartSine samaritan PAD electrode gel being dry. The electrodes are sealed in a be stored with an Adult Pad-Pak inserted and that a protective foil and should only be opened during use.
  • Page 23 EN-US Adult Pad-Pak WARNING Not for use on patients under 1 year old. WARNING DO NOT DELAY THERAPY IF YOU ARE UNSURE OF THE EXACT AGE OR WEIGHT. If the Pediatric-Pak is unavailable, you may use the Pad-Pak. CAUTION Single Use ONLY. Reuse may cause device to be unable to deliver therapy leading to Pediatric Pad-Pak a failure to resuscitate.

  • Page 24: Electrode Placement

    Electrode Placement Adult placement For a patient over 8 years of age or weighing over 55 lb (25 kg), place the electrodes on the patient’s BARE chest as shown in Figure 5. In large-breasted individuals, place the left electrode pad lateral to or underneath the left breast, avoiding breast tissue.

  • Page 25: Pediatric

    EN-US Pediatric placement For pediatric patients, there are two options for WARNING Electrode pads must be at least 1 electrode placement: anterior-posterior and anterior- in (2.5 cm) apart and should never touch one another. lateral. Pad placement for children Pad placement for smaller children If a child’s chest is large enough to permit at least a If a child’s chest is small, it may be necessary to place 1 in (2.5 cm) gap between the electrode pads, OR if...

  • Page 26: After Using The Heartsine Samaritan Pad

    After using the HeartSine samaritan PAD Cleaning the HeartSine samaritan PAD 3. Check the HeartSine samaritan PAD for dirt or contamination. If necessary, clean the device using 1. Remove the electrode pads from the patient and a soft cloth dampened by one of the following: stick the pads together face to face.

  • Page 27: Downloading And Submitting Event Information

    3. Install and launch the HeartSine Saver EVO software. 4. Follow the instructions provided in the Saver EVO manual to save or erase the event data on your HeartSine samaritan PAD. 5. Upload the Saver EVO file on the HeartSine Technologies site. User manual...

  • Page 28: Tracking

    Tracking Tracking requirements Medical device regulations require HeartSine Technologies to track the location of each HeartSine samaritan PAD AED, Pad-Pak, and Pediatric-Pak sold. Therefore, it is important that you register your device, either using our on-line registration tool at: https://secure.heartsine.com/ UserRegistration.html...

  • Page 29: Maintenance

    Maintenance EN-US HeartSine AEDs do not require any servicing or testing as the devices are designed to perform a weekly self-test. However, HeartSine Technologies recommends users perform regular maintenance checks, which include the following: Weekly ¨ Check the status indicator. The HeartSine Figure 10.

  • Page 30: Appendices

    Appendices Appendix A Symbols Appendix B Troubleshooting Appendix C Technical data Appendix D Voice prompts Appendix E Safety and effectiveness data Appendix F Limited warranty statement...

  • Page 31: Appendix A Symbols

    EN-US Appendix A Symbols Expiration date for On/Off Medical device Pad-Pak; YYYY-MM-DD Consult operating Dispose of in accordance Pressure limitations instructions with country requirements Single use item; do not DO NOT use if opened or Humidity limitations re-use damaged RX Only A-Recyclable Catalog number Caution: US Federal law...

  • Page 32: Appendix B Troubleshooting

    HeartSine samaritan PAD and listen for the voice prompt “Call for medical assistance”. Then press the On/Off button again to turn off the device. If either of these actions do not correct the problem, contact your Authorized Distributor or HeartSine Technologies immediately.
  • 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. “Warning off button You have pressed the On/Off button while the AED is being used to treat pressed”...
  • Page 34 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 under warranty if one or more of the following conditions apply: • Device has been opened.
  • Page 35 Service life Expected service life: Service life is defined as the length of the warranty period. Please refer to the HeartSine limited warranty statement for details (Appendix F). 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)

  • Page 36: Appendix C Technical Data

    Appendix C Technical data Pad-Pak and Pediatric-Pak specifications Weight: 0.44 lb (0.2 kg) Battery type: Disposable single-use combined battery and defibrillation electrode cartridge (lithium manganese dioxide (LiMnO ) 18V) Battery capacity (new): >60 shocks at 200J or 6 hours of battery use Battery capacity (4 years): >10 shocks at 200 J Electrode type:...
  • Page 37 EN-US Languages: HeartSine samaritan PAD is available in English or Spanish. Contact your HeartSine Authorized Distributor. Controls: On/Off button (all models), shock button (SAM 350P and 450P only) and green tab Defibrillator performance Charging time: Typically 150J in < 8 seconds, 200J in < 12 seconds...
  • Page 38 Technical data SCOPE Biphasic Waveform The HeartSine samaritan PAD delivers a Self-Compensating Output Pulse Envelope (SCOPE) biphasic waveform (see Figure 13) 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 EN-US Table 3. Pad-Pak waveform specification Resistance (Ohms) Waveform voltages (Volts) Waveform duration (ms) 1880 1880 1880 1880 1880 1880 14.5 14.5 1880 17.5 17.5 1880 1880 20.5 20.5 Table 4. Pediatric-Pak waveform specification Resistance (Ohms) Waveform voltages (Volts) Waveform duration (ms) 10.8 11.5 NOTE: All values are nominal.
  • Page 40 Appendix C Technical data Table 5. Adult energy delivery range Patient resistance Rated delivered energy Actual delivered energy (Joules) (Ohms) (Joules) Min-max (150/200 J ± 10%) 135 - 165 135 - 165 135 - 165 135 - 165 135 - 165 135 - 165 135 - 165 135 - 165...
  • Page 41 EN-US Table 6. Pediatric energy delivery range Patient resistance Rated delivered energy Actual delivered energy (Joules) (Ohms) (Joules) Min-max (50 J ± 15%) 42.5 - 57.5 42.5 - 57.5 42.5 - 57.5 42.5 - 57.5 42.5 - 57.5 42.5 - 57.5 42.5 - 57.5 Table 7.
  • Page 42 The HeartSine 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 HeartSine 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 43 EN-US Table 8. Performance of the HeartSine samaritan PAD ECG arrhythmia analysis algorithm Rhythm class Minimum test Test sample Performance Observed sample size size goal performance Shockable rhythm: Sensitivity Coarse ventricular >90% fibrillation Shockable rhythm: Sensitivity Rapid ventricular >75% (AAMI...
  • Page 44 Appendix C 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”...
  • Page 45 The HeartSine samaritan PAD is intended for use in the electromagnetic environments specified in Table 10 below and Table 11 on the following page. The user of the HeartSine samaritan PAD should assure that it is used in such an environment.
  • Page 46 Appendix C Technical data Table 11. Electromagnetic immunity Immunity test IEC 60601 test level Compliance level Electrostatic discharge (ESD) ± 8kV Contact ± 8kV Contact IEC/EN 61000-4-2 ± 15kV Air ± 15kV Air Electrical fast transients/bursts Not applicable Not applicable IEC/EN 61000-4-4 Surges, line to line Not applicable...
  • Page 47 If the measured field strength in the location in which the HeartSine samaritan PAD is Power frequency magnetic fields should be at levels intended to be used exceeds the applicable RF compliance...

  • Page 48: Appendix D Voice Prompts

    Appendix D Voice prompts Following are the voice prompts used by the HeartSine 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.
  • Page 49 EN-US For all patients PROMPT SAM 350P SAM 360P SAM 450P 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”* “Remain calm”* If a shock is required “Stand clear of patient;...

  • Page 50: Appendix E Safety And Effectiveness Data

    2,3,4 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 51 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 52 . 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 53 EN-US Table 12: Summary of successful defibrillation episodes with both devices HeartSine samaritan Philips HeartstreamXL (100-150-200J) (150-150-150J) Success by Frequency Proportion Frequency Proportion Mean Probability that difference samaritan better than Heartstream First shock 0.582 0.642 -0.0598 0.0742 0.210 Second shock 0.823...
  • Page 54 (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 55 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 56: Appendix F Limited Warranty Statement

    For how long? HeartSine warrants, from the date of the sale to the original end user, the HeartSine samaritan PAD for the full eight (8) year service life and the HeartSine samaritan PAD Trainer and HeartSine Gateway for a period of two (2) years.
  • Page 57 800 442 1142. Our technical representative will try to resolve your issue over the phone. If necessary, and at our sole discretion, we will arrange for service or a replacement of your HeartSine product. You must not send back any product without our authorization.
  • Page 58 References 1. Panchal R, Bartos JA, Cabañas JG, et al. Part 3: Adult Basic and Advanced Life Support 2020 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2020;142(suppl 2):S366–S468. 2. Berg RA, Chapman FW, Berg MD, et al. Attenuated adult biphasic shocks compared with weight-based monophasic shocks in a swine model of prolonged pediatric ventricular fibrillation.
  • Page 60 HeartSine samaritan PAD user manuals in all available languages can be found on our website at heartsine.com/product-manuals To view information regarding environmental regulatory requirements, including the European REACH regulation, please refer to heartsine.com/environmental-regulations For further information contact us at heartsinesupport@stryker.com or visit our web site at...

This manual is also suitable for:

Samaritan pad sam 360pSamaritan pad sam 450p

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