HeartSine samaritan PAD User Manual
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HeartSine samaritan PAD User Manual

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HeartSine
user manual
SAM 350P semi-automatic defibrillator
SAM 360P fully automatic defibrillator
SAM 500P semi-automatic defibrillator with CPR Advisor™
samaritan
®
EN-UK
PAD
®

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Summary of Contents for HeartSine samaritan PAD

  • Page 1 EN-UK HeartSine samaritan ® ® user manual SAM 350P semi-automatic defibrillator SAM 360P fully automatic defibrillator SAM 500P semi-automatic defibrillator with CPR Advisor™...
  • Page 2 Pad-Pak expiration date (YYYY/MM/DD or YYYY-MM-DD) Write information about your automated external defibrillator (AED) in this section. Model ¨ HeartSine SAM 350P ¨ HeartSine SAM 360P ¨ HeartSine SAM 500P Serial number __________________________________________ Pad-Pak expiration date _______________________________ Date of purchase ______________________________________...

  • Page 3: Table Of Contents

    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 Authorised Distributor or HeartSine Technologies directly.

  • Page 4: Intended Use

    Intended use Intended purpose Contraindications for use Do not use the HeartSine samaritan PAD to provide The HeartSine samaritan PAD family of AEDs is designed to automatically assess the patients heart treatment if the patient is responsive or conscious. rhythm, advise and/or automatically deliver a...

  • 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 oxygen mask delivery systems. However, to avoid...

  • Page 6: Cautions

    30 cm pacemaker. A noticeable lump with a surgical scar (12 in) to any part of the HeartSine samaritan PAD should indicate the location of an implanted device. including cables specified by the manufacturer.

  • Page 7: Symbols

    HeartSine samaritan PAD in water or any type of in the region where it is to be used. fluid. Contact with fluids may seriously damage the Symbols device or cause fire or a shock hazard.

  • Page 8: Overview

    If a contract properly. Ventricular fibrillation is the most shock is required, the HeartSine samaritan PAD will commonly identified arrhythmia in SCA patients. charge and advise the user to press the shock button...

  • Page 9: Introduction

    SAM 360P IS A FULLY About the HeartSine samaritan PAD AUTOMATIC DEFIBRILLATOR. WHEN REQUIRED, The HeartSine samaritan PAD family of AEDs is IT WILL DELIVER A SHOCK TO THE PATIENT designed to quickly deliver a defibrillation shock WITHOUT USER INTERVENTION to victims of sudden cardiac arrest (SCA).

  • Page 10: Recommended Training

    The SAM 500P uses may be used by an untrained lay rescuer impedance cardiogram measurements to analyse If potential users of the HeartSine samaritan PAD the force and rate of compressions and provide the are not trained in these techniques, contact your...

  • Page 11: Sam 350P Layout

    EN-UK text goes here Introduction SAM 350P layout Data port Status indicator Remove blue cover The SAM 350P is and plug in the custom ready for use when USB data cable to this indicator is download event data flashing green. from the AED.

  • Page 12: Sam 360P Layout

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

  • Page 13: Sam 500P Layout

    EN-UK text goes here Introduction SAM 500P layout Data port Status indicator Remove blue cover and plug in the The SAM 500P is custom USB data cable to download ready for use when event data from the AED. this indicator is flashing green.

  • Page 14: Set-Up

    Figure 2) for use on smaller children (from 1 to 8 Verify that the contents include the HeartSine years old and weighing under 25 kg (55 lb)). samaritan PAD, carry case, Pad-Pak, user manual, and warranty registration card. WARNING: DO NOT DELAY TREATMENT Pad-Pak TRYING TO DETERMINE THE PATIENT’S EXACT...

  • Page 15: Putting The Heartsine Samaritan Pad Into Service

    Pad-Pak at this time. If you have pulled the tab and opened the electrode drawer, you may need to 3. Place the HeartSine samaritan PAD face up on replace your Pad-Pak a flat surface and slide the Pad-Pak into the HeartSine samaritan PAD (see Figure 4) until you hear the “double click”...

  • Page 16: Preparation Checklist

    Store the HeartSine samaritan ¨ Step 4. Turn on the HeartSine samaritan PAD to PAD out of reach of small children and pets. Be sure to store the device according to the check operation.

  • Page 17: Using The Heartsine Samaritan Pad

    Once a non-shockable rhythm is provide you with step-by-step voice prompts. For a detected, the HeartSine samaritan PAD will end its full list of voice prompts for your device see Voice ready to shock condition if it had previously decided prompts in Appendix D.
  • Page 18 Using the HeartSine samaritan PAD 4. Call for medical assistance 5. Get the AED • Ask others nearby to get the AED 6. Begin CPR (until AED arrives) While waiting for the AED, begin CPR • Push hard between 5 to 6 cm (2 to 2.4 inches) deep •...
  • Page 19 EN-UK text goes here Using the HeartSine samaritan PAD 7. Press the On/Off button to turn on the AED and follow the voice directions • Kneel next to the patient • Place the AED on the floor next to you •...
  • Page 20 Using the HeartSine samaritan PAD 10. Pull the green tab • Pull the green tab to remove the electrode pad pouch from the AED “Pull green tab to remove pads.” 11. Open the electrode pouch • With both thumbs on the foil tabs, open the foil to release...
  • Page 21 EN-UK text goes here Using the HeartSine samaritan PAD 13. Place first pad • Place the first pad as shown in picture • For a patient over 8 years of age or weighing over 25 kg (55 lb), apply the first electrode pad firmly to the patient’s bare chest, vertically as shown in picture •...
  • Page 22 Using the HeartSine samaritan PAD 15. Place second pad • For a patient over 8 years of age or weighing over 25 kg (55 lb), apply the second electrode pad firmly to the patient’s bare chest, horizontally on the rib cage as shown in picture •...
  • Page 23 EN-UK Using the HeartSine samaritan PAD 16. Do not touch the patient • When you hear “Analysing, do not touch the patient,” make sure no one is touching the patient “Analysing, do not touch the patient.” 17. If a shock is needed, stand clear and press the shock button (as directed) •...
  • Page 24 Using the HeartSine samaritan PAD 18. 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 25: Pad-Pak And Pediatric-Pak

    PAD with a Pediatric-Pak inserted you The Pad-Pak or Pediatric-Pak accessory contains should hear the voice prompt “Child patient” the battery to power the HeartSine samaritan PAD and two electrode pads to provide the electrical Note: The Pediatric-Pak contains a magnetic connection to the patient’s chest for delivery of...
  • Page 26 text goes here Pad-Pak and Pediatric-Pak 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: Pad-Pak and Pediatric-Pak are single use only.

  • Page 27: Electrode Placement

    Electrode placement EN-UK Adult placement For a patient over 8 years of age or weighing over 25 kg (55 lb), 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 28: Pediatric Placement

    text goes here Electrode placement Pediatric placement WARNING: ELECTRODE PADS MUST BE AT For pediatric patients, there are two options LEAST 2.5 CM (1 IN) APART AND SHOULD NEVER for electrode placement: anterior-posterior and TOUCH ONE ANOTHER anterior-lateral. Pad placement for smaller children Pad placement for children If a child’s chest is small, it may be necessary to If a child’s chest is large enough to permit at least...

  • Page 29: After Using The Heartsine Samaritan Pad

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

  • Page 30: Downloading And Submitting Event Information

    Authorised Distributor or HeartSine Technologies HeartSine Saver EVO software lets you manage the directly. event data after your HeartSine samaritan PAD is used. You can provide this data, if requested, to a Disposal patient’s doctor, and/or use it to obtain a free Pad- The Pad-Pak and Pediatric-Pak contain lithium Pak if you have an eligible event.

  • Page 31: Tracking

    When you register your AED, we will contact you with any important notifications about the HeartSine samaritan PAD, such as software updates or field safety corrective actions. User manual...

  • Page 32: Maintenance

    Authorised Distributor for a replacement. ¨ If you hear a warning message when you turn Testing with simulators and manikins on your HeartSine samaritan PAD or if, for HeartSine AEDs cannot be tested using industry- any reason, you suspect that your HeartSine standard simulators and manikins.

  • Page 33: Appendix A Symbols

    Appendix A EN-UK Symbols Consult operating Distributor On/Off instructions Date of Manufacture; Single use item; do not Medical device YYYY-MM-DD re-use Temperature limitation as 50ºC 0ºC (122ºF) A-Recyclable Pressure limitations indicated (32ºF) Expiration date for Non-rechargeable battery Humidity limitations Pad-Pak; YYYY-MM-DD Dispose of in accordance Do not short circuit battery Catalogue number...

  • Page 34: 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...
  • Page 35 WARNING: 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 AUTHORISED DISTRIBUTOR IMMEDIATELY “Warning, off button You have pressed the On/Off button while the AED is being used to pressed”...
  • Page 36 Authorised Distributor or HeartSine Technologies Technical Support at: heartsinesupport@stryker.com Warranty exclusion HeartSine Technologies or its Authorised Distributors are not obliged to replace or repair under warranty if one or more of the following conditions apply: • AED has been opened •...
  • Page 37 Service life Service life is defined as the length of the warranty period. Please refer Expected service life: to the HeartSine limited warranty statement for details (Appendix E) Physical specifications (with Pad-Pak installed) Size: 20 cm x 18.4 cm x 4.8 cm (8.0 in x 7.25 in x 1.9 in) Weight: 1.1 kg (2.4 lb)

  • Page 38: Appendix C Technical Data

    Appendix C Technical data Pad-Pak and Pediatric-Pak specifications Weight: 0.2 kg (0.44 lb) Disposable single-use combined battery and defibrillation electrode Battery type: cartridge (lithium manganese dioxide (LiMnO ) 18V) Battery capacity (new): >60 shocks at 200 J or 6 hours of battery use Battery capacity (4 years): >10 shocks at 200 J Electrode type:...
  • Page 39 Extensive voice prompts guide the user through the operation Audible prompts: sequence (see Voice prompts in Appendix D) Languages: Contact your HeartSine Authorised Distributor. On/Off button (all models), shock button (SAM 350P and 500P) and Controls: green tab Defibrillator performance Charging time: Typically 150 J in <...
  • Page 40 Appendix C Technical data Event recording Type: Internal memory Memory: 90 minutes of ECG (full disclosure) and event/incident recording Custom USB data cable (optional) directly connected to a PC with Review: Saver EVO Windows-based data review software Electromagnetic compatibility/battery safety EMC: IEC/EN 60601-1-2 (see pages C-12 to C-14 for full details) RTCA/DO-160G, Section 21 (Category M)
  • Page 41 Technical data EN-UK SCOPE biphasic waveform The HeartSine samaritan PAD delivers a Self-Compensating Output Pulse Envelope (SCOPE) biphasic waveform (see Figure 13) which automatically optimises 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 optimised, impedance-compensated, biphasic, truncated exponential waveform that incorporates an escalating energy protocol of 150 Joules, 150 Joules, and 200 Joules.
  • Page 42 Appendix C Technical data 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) 11.5 175*...
  • Page 43 Technical data EN-UK 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 44 Appendix C Technical data 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 - 57.5 175* 42.5 - 57.5...
  • Page 45 Technical data EN-UK Motion detection algorithm (SAM 360P only) The SAM 360P uses the HeartSine 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 46 Appendix C Technical data 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%...
  • Page 47 Technical data EN-UK CPR Advisor analysis algorithm SAM 500P utilises the ICG (Impedance Cardiogram) capability to assess the force and rate of chest compressions being applied during cardiopulmonary resuscitation (CPR). Based on the measured rate, SAM 500P provides verbal feedback to the user to “Push faster” or “Push slower” in accordance with the current ERC/AHA resuscitation guidelines (target CPR rate of at least 100-120 CPM).
  • Page 48 The HeartSine samaritan PAD is intended for use in the electromagnetic environments specified in Table 9 below and Table 10 on the following page. The user of the HeartSine samaritan PAD should assure that it is used in such an environment.
  • Page 49 Technical data EN-UK Table 10. 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 50 Portable and mobile RF communications equipment should be used IEC/EN 61000-4-3 no closer to any part of the HeartSine samaritan PAD, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter, or 30...
  • Page 51 If the measured field strength in the location in which the 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 the HeartSine samaritan PAD if possible.

  • Page 52: Appendix D Voice Prompts

    Appendix D Voice prompts ollowing are the voice prompts used by the HeartSine samaritan PAD. 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...
  • Page 53 Voice prompts EN-UK For all patients Prompt SAM 350P SAM 360P SAM 500P 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 54: 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. Products with a stated expiration date are warranted until such expiration date.
  • Page 55 You must not send back any product without our authorisation. What we will do: If your HeartSine product contains defects in material or workmanship and it is returned, at the direction of a technical service representative, within the warranty period, we, at our sole discretion, will repair your product or replace it with a new or reconditioned product of the same or similar design.
  • Page 56 HeartSine samaritan PAD user manuals in all available languages can be found on our website at uk.heartsine.com/product-manuals The HeartSine samaritan PAD (SAM 350P, SAM 360P and SAM 500P) Summary of Safety and Clinical Performance (SSCP) will be available via EUDAMED when fully implemented by the European Commission.

This manual is also suitable for:

Sam 350pSam 360pSam 500p

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