HeartSine samaritan PAD User Manual
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HeartSine samaritan PAD User Manual

Semi-automatic defibrillator
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HeartSine
user manual
SAM 350P
Semi-automatic defibrillator
Important:
Please watch online training videos
heartsine.com/videos
samaritan
®
EN-US
PAD
®

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Summary of Contents for HeartSine samaritan PAD

  • Page 1 EN-US HeartSine samaritan ® ® user manual SAM 350P Semi-automatic defibrillator Important: Please watch online training videos heartsine.com/videos...

  • Page 2: Table Of Contents

    Introduction About HeartSine samaritan PAD Recommended training Safety and effectiveness data Getting to know your HeartSine SAM 350P AED About Pad-Pak and Pediatric-Pak Set up your AED Use your AED on an adult Use your AED on a young child...
  • Page 3 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

    It is indicated for use on children between 1 and 8 years of age or up to 55 lb (25 kg) when used with the Pediatric-Pak (Pad-Pak-02). Contraindications for use Do not use the HeartSine samaritan PAD to provide treatment if the patient is responsive or conscious. EN-US...

  • Page 5: Warnings And Cautions

    Warnings and cautions Avoid explosive or flammable gases Warnings HeartSine samaritan PAD is safe to use with oxygen mask delivery systems. However, to avoid Patients suitable for treatment the risk of an explosion, it is strongly advised that you HeartSine samaritan PAD has been designed to work do not use HeartSine samaritan PAD in the vicinity on unconscious, nonresponsive patients.

  • Page 6: Cautions

    However, the IP56 the location of an implanted device. rating does not cover the immersion of any part of HeartSine samaritan PAD in water or any type of fluid. Contact with fluids may seriously damage the Cautions device or cause fire or a shock hazard.

  • Page 7: Notes

    SAM 350P is intended for use in the public access Testing with simulators and manikins and home environments. Anyone who might use HeartSine AEDs cannot be tested using industry- HeartSine SAM 350P should: standard simulators and manikins. • Watch the training videos at heartsine.com/videos Symbols •...

  • Page 8: Overview

    It is important to note that cardiac defibrillators, like heart. This treatment is called defibrillation. HeartSine samaritan PAD, will not administer a shock Ventricular tachycardia unless a lifesaving shock is required.
  • Page 9 Overview When should I use the AED? You should use your HeartSine SAM 350P on a person suffering cardiac arrest who is: • Unconscious • Not breathing normally You can tell this by doing the following: Shake the person • Gently shake the person to see if they respond •...

  • Page 10: Introduction

    AED tells you that a shock is required. • Review these materials periodically HeartSine samaritan PAD is designed to operate in Training on CPR and in the use of an AED is strongly accordance with the current joint American Heart recommended.

  • Page 11: Getting To Know Your Heartsine Sam 350P Aed

    Introduction Getting to know your HeartSine SAM 350P AED Data port Status indicator Remove blue cover and 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.

  • Page 12: About Pad-Pak And Pediatric-Pak

    Each Pad-Pak and Pediatric-Pak is a single-use removable cartridge that includes the battery and One Pad-Pak is always provided as standard with electrode pads in a single unit, for use with HeartSine each HeartSine samaritan PAD. Pediatric-Pak or samaritan PAD. Each Pad-Pak and Pediatric-Pak additional Pad-Paks are available as an option.
  • Page 13 Introduction Table 1. Comparing Pad-Pak, Pediatric-Pak and Aviation Pad-Pak Feature Pad-Pak Pediatric-Pak Aviation Pad-Pak Color Gray Pink Gray (with aircraft symbol) Intended patient Adult and children Children Adult and children age and weight > 8 years or 1 – 8 years or >...

  • Page 14: Set Up Your Aed

    > 8 years or > 25 kg (55 lb). • Pediatric-Pak: Intended for use on children between the age of 1-8 years or < 25 kg (55 lb). LiMnO2 Note: Retain the Pad-Pak packaging in case you need to return the Pad-Pak to HeartSine Technologies EN-US...
  • Page 15 3. Remove AED from carry case and place AED and Pad-Pak on a table • Remove AED from carry case • Place your HeartSine SAM 350P AED and Pad-Pak face up on a table • Check that the expiration date (YYYY-MM-DD) on the back of...
  • Page 16 text goes here Set up your AED 5. Check the language on the AED • Press the On/Off button to turn on the AED • Listen for – but do not follow – the voice prompts to ensure that you hear English and do not hear a warning message •...
  • Page 17 • Find the expiration date on the rear of the Pad-Pak (YYYY-MM-DD) and write it in the space provided • Write the date you purchased your HeartSine AED and the name of the company or store where you bought your AED...
  • Page 18 Set up your AED 8. Register your AED We are required to track the location of each HeartSine AED in the Scan the QR code with your market. Therefore, it is very important that you register your AED.
  • Page 19 32°F to 122°F (see environmental specifications in Technical data in Appendix C on page C-1) CAUTION: HeartSine Technologies recommends that you store a spare Pad-Pak with your HeartSine samaritan PAD in the rear section of the soft carry case User manual...
  • Page 20 text goes here Set up your AED 12. Create a service schedule • Create a weekly and monthly service schedule • See Maintain your AED on page 41 13. Check that you completed all of the set up steps: ¨ Step 1. Watch the Set up your AED video. ¨...

  • Page 21: Use Your Aed On An Adult

    Use your AED on an adult Defibrillation therapy is tailored depending on whether a Pad-Pak or Pediatric-Pak is installed. For an adult patient or a child patient over 8 years of age or weighing 55 lb or over, use the Pad-Pak. Follow these steps to use your AED, which will provide you with step-by-step voice prompts.
  • Page 22 text goes here Use your AED on an adult 3. Check for airway • Check that the patient’s airway is not blocked, using a head-chin tilt if necessary 4. Call 911 for medical help 5. Get the AED • Ask others nearby to get the AED EN-US...
  • Page 23 text goes here Use your AED on an adult 6. Begin CPR (until AED arrives) While waiting for the AED, begin CPR. • Push hard between 2 to 2.4 inches (5 to 6 cm) deep • Push fast at a rate of between 100 and 120 compressions per minute •...
  • Page 24 text goes here text goes here Use your AED on an adult 9. Pull the green tab • Pull the green tab to remove the electrode pad pouch from the AED “Pull green tab to remove pads.” 10. Open the electrode pouch •...
  • Page 25 text goes here Use your AED on an adult 12. Place first pad • Place the first pad as shown in picture • For a patient over 8 years of age or weighing over 55 lb (25 kg), place the first pad vertically on the bare right chest •...
  • Page 26 text goes here Use your AED on an adult 14. Place second pad • Place the second pad as shown in picture • For a patient over 8 years of age or weighing over 55 lb (25 kg), place the second pad horizontally on the bare left rib cage •...
  • Page 27 CAUTION: Once a non-shockable rhythm is detected, HeartSine samaritan PAD will end its ready to shock condition if it had previously decided to shock “Stand clear of patient. Shock advised.”...
  • Page 28 text goes here Use your AED on an adult 17. Begin CPR when directed • When you hear “Begin CPR,” begin CPR on the patient • Place overlapping hands in the middle of the patient’s chest • With your arms straight, press down hard and quickly in time with the beat •...

  • Page 29: Use Your Aed On A Young Child

    Use your AED on a young child Defibrillation therapy is tailored depending on whether a Pad-Pak or Pediatric-Pak is installed. If the person is a young child (from 1 to 8 years of age or weighing 55 lb or less), you should use a pink Pediatric-Pak in place of the gray Pad-Pak, if available.
  • Page 30 Use your AED on a young child 3. Check for airway • Check that the patient’s airway is not blocked, using a head- chin tilt if necessary 4. Call 911 for medical help 5. Get the AED 6. Begin CPR (until AED arrives) •...
  • Page 31 • If you don’t have a Pediatric-Pak, continue to use the Pad-Pak • Press the On/Off button to turn on AED • Follow the directions Note: When you switch on your HeartSine AED with a Pediatric-Pak inserted you should hear the voice prompt “Child patient” 8. Expose and dry chest area •...
  • Page 32 Use your AED on a young child 10. Open the electrode pouch • With both thumbs on the foil tabs, open the foil to release the pads WARNING: DO NOT USE THE PADS IF POUCH IS OPENED OR DAMAGED; IMMEDIATELY REPLACE THE PAD-PAK OR PEDIATRIC-PAK 11.
  • Page 33 Use your AED on a young child 13. Peel second pad from liner • With both thumbs on the white and clear round tabs, peel the first pad from the plastic liner 14. Place second pad • If the child’s chest is small and you cannot place the pads at least 1 inch apart, place the second pad on the center of the ribcage on the child’s bare back as shown •...
  • Page 34 Use your AED on a young child 15. Do not touch the child When you hear “Analyzing, do not touch the patient,” make sure no one is touching the child “Analyzing, do not touch the patient.” 16. If a shock is needed, stand clear and press the shock button (as directed) •...
  • Page 35 Use your AED on a young child 17. Begin CPR when directed • When you hear “Begin CPR,” begin CPR on the child • Place overlapping hands in the middle of the child’s chest • With your arms straight, press down hard and fast in time with the beat •...

  • Page 36: After You Use Your Aed

    AED, follow the steps in the next section, Maintain your AED, to ensure that your AED is ready to use. In the event you have used your HeartSine samaritan PAD, you must clean the AED and replace the Pad-Pak, which can be used only once.
  • Page 37 After you use your AED 3. Separate electrode pads from battery • Cut both cords to separate pads, tray and foil from the battery cartridge 4. Dispose of electrode pads and battery separately • As the electrode pads may have contacted human bodily tissue, fluid or blood, they should be disposed of as infectious waste •...
  • Page 38 • You may use soapy water or 70% isopropyl alcohol to remove dirt that is hard to clean CAUTION: Do not clean HeartSine SAM 350P with abrasive materials, cleaners or solvents CAUTION: Do not place any part of the AED in water or...
  • Page 39 After you use your AED 7. Insert a new Pad-Pak and note new expiration date • Before you insert the new Pad-Pak, note the expiration date on the inside front cover of your User Handbook (see Set up your AED on page 14) 8.
  • Page 40 After you use your AED 9. Tell us when you use your AED! Data captured when you use your AED on a patient is kept on HeartSine SAM 350P until it is erased or overwritten. You can retrieve this data...

  • Page 41: Maintain Your Aed

    Your HeartSine SAM 350P AED runs a self-test each Sunday at 7 p.m. Eastern Time. If an issue is found during the self-test, the status indicator will change from flashing green to flashing red and you will hear an alert and voice instructions.

  • Page 42: Each Month

    • If the AED is damaged, replace it immediately or contact your Authorized Distributor or email heartsinesupport@stryker.com 3. Look at the Pad-Pak expiration date • If the Pad-Pak expiration date (YYYY-MM-DD) has passed or is close, immediately replace the Pad-Pak ©2021 HeartSine Technologies heartsinesupport@stryker.com > 25kg (55 lb) heartsine.com (> 8 years) H061-019-020-AC HeartSine Technologies Ltd.
  • Page 43 Appendix A Symbols Authorized Representative in On/Off Lot number the European community Date of manufacture; Consult operating YYYY-MM-DD Medical device instructions Temperature limitation as 122ºF 32ºF (50ºC) Single use item; do not indicated (0ºC) Pressure limitations re-use Expiration date for Pad-Pak;...
  • Page 44 Pad-Pak. If the expiration date has not passed, press the On/ Off button on the face to turn on 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.
  • Page 45 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 pressed” You have pressed the On/Off button while the AED is being used prompt to treat a patient.
  • Page 46 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: • AED has been opened •...
  • Page 47 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 48 Audible prompts: Extensive voice prompts guide the user through the operation sequence (See Voice prompts in Appendix D) Languages: HeartSine samaritan PAD 350P is available in English Controls: On/Off button, Shock button and green tab EN-US...
  • Page 49 Technical data Defibrillator performance Charging time: Typically 150 J in < 8 seconds, 200 J in < 12 seconds Time to shock delivery Typically 8 seconds following CPR: Impedance range: Adult: 20 Ω to 230 Ω Pediatric: 0 Ω to 176 Ω Therapeutic shock Waveform: SCOPE (Self Compensating Output Pulse Envelope) optimized biphasic...
  • Page 50 Technical data SCOPE biphasic waveform HeartSine samaritan PAD delivers a Self-Compensating Output Pulse Envelope (SCOPE) biphasic waveform (see Figure 1) 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 51 Technical data Table 2. 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 3. Pediatric-Pak waveform specification Resistance (Ohms) Waveform voltages (Volts) Waveform duration (ms) 10.8 11.5...
  • Page 52 Appendix C Technical data Table 4. 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 53 Technical data Table 5. 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 6.
  • Page 54 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, HeartSine samaritan PAD will charge and advise the user to stand clear and to press the shock button. If no shock is advised, the device will pause to allow the user to deliver CPR.
  • Page 55 Technical data Table 7. 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%...
  • Page 56 (MRI) equipment. HeartSine samaritan PAD is intended for use in the electromagnetic environments specified in Table 8 below and Table 9 on the following page. The user of HeartSine samaritan PAD should assure that it is used in such an environment.
  • Page 57 Technical data Table 9. 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 Not applicable...
  • Page 58 Portable and mobile RF communications equipment should be used IEC/EN 61000-4-3 no closer to any part of HeartSine samaritan PAD, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter, or 12 in (30...
  • Page 59 If the measured field strength in the location in which HeartSine samaritan PAD is intended to be used exceeds the applicable RF compliance levels noted above, the device should be observed to verify normal operation. If abnormal performance is observed, consideration should be given to relocating HeartSine samaritan PAD if possible.
  • Page 60 Appendix D Voice prompts Following are the voice prompts used by HeartSine samaritan PAD. Read the voice prompts in advance of use to be familiar with the types of instructions given. Prompt Before and during analysis “Adult patient” (heard when Pad-Pak installed) “Child patient”...
  • Page 61 Voice prompts Prompt 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 62 In lieu of such a trial, the risks of the device are based on nonclinical laboratory and animal studies as well as data collected in published literature 2,3,4 The results from the preclinical laboratory testing performed on the HeartSine 350P device demonstrated appropriate electrical safety, electromagnetic compatibility, biocompatibility, mechanical integrity, and overall performance.
  • Page 63 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; and •...
  • Page 64 . 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 .
  • Page 65 Safety and effectiveness data Table 10. Summary of successful defibrillation episodes with both devices HeartSine samaritan Philips HeartstreamXL (100-150-200 J) (150-150-150 J) Success by Frequency Proportion Frequency Proportion Mean Probability that difference samaritan better than Heartstream First shock 0.582 0.642 -0.0598...
  • Page 66 (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 67 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 68 Stryker please contact Customer Support at 800 442 1142 or heartsinesupport@stryker.com. 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. Products with a stated expiration date are warranted until such expiration date.
  • Page 69 800 442 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 70 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 72 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, please refer to heartsine.com/environmental-regulations For further information contact us at heartsinesupport@stryker.com or visit our website at heartsine.com...

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