HeartSine SAM 500P User Manual
  1. Manuals
  2. Brands
  3. HeartSine Manuals
  4. Medical Equipment
  5. samaritan PAD SAM 500P
  6. User manual

HeartSine SAM 500P User Manual

Samaritan pad with cpr advisor
Hide thumbs Also See for SAM 500P:
Table of Contents

Advertisement

Quick Links

HeartSine samaritan PAD
with CPR Advisor
SAM 500P
User Manual

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the SAM 500P and is the answer not in the manual?

Questions and answers

Sally Ng
July 10, 2025

Hi, I would like to enquire 1 no of HeartSine SAM 500P CPR Advisor

0

Related Manuals for HeartSine SAM 500P

Summary of Contents for HeartSine SAM 500P

  • Page 1 HeartSine samaritan PAD with CPR Advisor SAM 500P User Manual...

  • Page 2: Table Of Contents

    Contents Contents Service and Maintenance Warnings and Cautions Tracking Requirements Introduction Data Management The HeartSine Samaritan PAD with CPR- Troubleshooting Advisor SAM 500P Status indicator flashing red Sudden Cardiac Arrest (SCA) Low battery warning Ventricular fibrillation Memory full warning CPR Quality...
  • Page 3 Symbols used in this manual Defibrillation protected, Type BF connection Warning: Risk of death or Do not expose to high heat or open serious injury flame. Do not incinerate Does not contain natural rubber latex Non-sterile Caution: Risk of injury Recyclable Non- rechargeable battery Do not short circuit battery...

  • Page 4: Warnings And Cautions

    Risk of electric shock patients. If the patient is responsive or The SAM 500P delivers therapeutic conscious, do not use the SAM 500P to electrical shocks that can cause serious provide treatment. harm to either operators or bystanders.
  • Page 5 500P is safe to use with oxygen mask pads delivery systems. However, to avoid Proper placement of the SAM 500P’s the risk of an explosion, it is strongly electrode pads is critical. You must strictly advised that you do NOT use the SAM...
  • Page 6 To safeguard against interference, you broken or compromised in any way. If you must operate the SAM 500P at least 2 suspect that the Pad-Pak is damaged, you m (6 feet) away from all radio frequency must replace it immediately.
  • Page 7 Our HeartSine Technologies. No part of this algorithm uses heart rate variability as manual may be reproduced or transmitted one of its criteria for measuring ventricular in any form or by any means, electrical or fibrillation (VF).
  • Page 8 Use of accessories The SAM 500P is a self-contained device. Do not use any unauthorised accessories with it. The SAM 500P may malfunction if non-approved accessories are used. Regular maintenance Check the device periodically. See ‘Service and Maintenance’...

  • Page 9: Introduction

    SCA. If you are Sudden Cardiac Arrest (SCA). experiencing symptoms of a heart attack The SAM 500P is designed to operate (chest pain, pressure, shortness of breath, in accordance with the joint European tight feeling in the chest or elsewhere...

  • Page 10: Cpr Quality

    SAM 500P uses these measurements resuscitation (CPR) they are providing to estimate the impedance changes in to the victim. The SAM 500P uses the chest and so as a way to determine ICG measurements to analyse the the effectiveness of compressions given effectiveness and rate of compressions during CPR.

  • Page 11: Recommended Training

    SCA is a condition requiring immediate CPR metronome emergency medical intervention. Due to the nature of the condition, this The SAM 500P will play an audible intervention can be performed before click and flash the Safe To Touch seeking the advice of a physician.

  • Page 12: Sam 500P Overview

    Do not touch icon to deliver a Do not touch the patient therapeutic shock. when the action arrows around this icon are flashing. The SAM 500P may be analysing the patient’s heart rhythm or about to charge, preparing to deliver a shock. Paediatric...

  • Page 13: Preparation

    Preparation Unpacking Checks before putting into service Check that the contents include the User Check the expiry date (year/month) on the Manual, soft case, Pad-Pak, guarantee rear of the Pad-Pak (see the illustration card and Quick Start Guide. below). If the expiry date has passed, you must replace the Pad-Pak.
  • Page 14 (see ‘SAM 500P Overview’ on page 12) will blink. If so, your SAM 500P is ready for use. Notice: Do NOT pull the green tab on the Pad-Pak. If you have opened the electrode drawer, you must replace your Pad-Pak.

  • Page 15: Guidelines For Storage

    Guidelines for storage Place the SAM 500P in its supplied soft carry case. Store the SAM 500P in an unobstructed, secure location in a clean, dry environment. Be sure to store according to specifications (see ‘Technical Data’ on page 24).

  • Page 16: Using The Sam 500P

    Using the SAM 500P The HeartSine Samaritan PAD with CPR- Refer to the separate Quick Start Guide. Advisor SAM 500P is indicated for use on During use the SAM 500P will give victims of sudden cardiac arrest who are extensive voice prompts to guide the user.

  • Page 17: After Use

    After use Do not dispose of the SAM 500P or Pad- Pak in the normal waste. Dispose of it at Turn off the SAM 500P by pressing an appropriate recycling facility according the front panel. to local requirements. Alternatively return it to your distributor for disposal or Remove the electrode pads from replacement.
  • Page 18 Using the SAM 500P Check the SAM 500P for damage. If the SAM 500P is damaged, replace it immediately. Install a new Pad-Pak. Before installing, check the Pad-Pak expiry date (see ‘Preparation’ on page 13). After installation check the status indicator is...

  • Page 19: Service And Maintenance

    If the date has expired, replace with a new Pad-Pak or contact your local HeartSine distributor for a replacement. 4. If you hear a warning message when you turn on your SAM 500P or if, for any reason, you have suspicions that your SAM 500P is not working correctly, contact your authorised distributor or HeartSine Technologies directly (support@ HeartSine.com).

  • Page 20: Tracking Requirements

    SAM 500P, 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 address or a change in ownership of your SAM 500P, please contact us with the updated information.

  • Page 21: Data Management

    Data Management The HeartSine Saver™ EVO software is an 2. Connect the USB cable to a PC. optional accessory. Contact your authorised 3. Launch the HeartSine Saver™ distributor or HeartSine Technologies EVO utility. directly about the After-Use Data Management Service.

  • Page 22: Troubleshooting

    The device will continue hear this message during use, continue to analyse the patient’s heart rhythm and to use the SAM 500P until the emergency advise when CPR is needed. services arrive. If available, prepare the...

  • Page 23: Device Service Required

    Device service required Warranty exclusion If the device plays the message ‘device HeartSine or its authorised distributors service required’, then it has detected a are not obliged to replace or repair under fault. Contact your authorised distributor or warranty if one or more of the following HeartSine directly for further instruction.

  • Page 24: Technical Data

    Technical Data Physical parameters (with Pad-Pak installed) Size: 20 x 18.4 x 4.8 cm (8.0 x 7.25 x 1.9 in) Weight: 1.1 kg (2.4 lbs) Environmental Operating temperature: 0 to 50 °C (32 to 122 °F) Standby temperature: 0 to 50 °C (50 to 122 °F) Transport temperature: -10 to 50 °C (14 to 122 °F) for up to two days.

  • Page 25: User Interface

    Test Pass - Ready State Audible prompts: Extensive voice prompts guide the user through the operation sequence Languages: Contact your HeartSine authorised distributor Controls: Two buttons: ‘On/Off’ and ‘Shock’ Defibrillator performance Times to shock delivery (fresh battery) or after 6 shocks Charging time: Typically 150 J in <...
  • Page 26 Technical Data Electrodes Type: Single-use pre-attached combined ECG sensor/ICG sensor/ defibrillation pad Placement: Adult: anterior-lateral Paediatric: electrodes anterior-posterior or anterior-lateral Active area: 100 cm Cable length: 3.5 ft (1 m) Shelf life: See the expiry date on the product Therapeutic shock Waveform: SCOPE (Self Compensating Output Pulse Envelope) biphasic escalating waveform.
  • Page 27 EN61000-4-2 (8 kV) RF Immunity: EN61000-4-3 80 MHz – 2.5 GHz, (10 V/m) Magnetic Field Immunity: EN61000-4-8 (3 A/m) Aircraft: RTCA/DO-160D, Section 21 (Category M) RTCA DO-227 (TSO-C142a) HeartSine Quality Management System ISO 9001 GB02/54194 ISO 13485 GB02/54195 EEC 92/43 GB02/54193...
  • Page 28 Technical Data SCOPE™ Biphasic Waveform 2000 The SAM 500P delivers a Self 1000 Compensating Output Pulse Envelope (SCOPE) biphasic waveform. This Volts waveform automatically optimises the waveform pulse envelope (amplitude, slope and duration) for a wide range of patient impedances, from 20 ohms to...
  • Page 29 47.5 55.6 shock is appropriate. If a shock is required, 51.3 50.4 the SAM 500P will charge and advise the user to press the shock button. If no shock 52.1 47.1 is advised, the device will pause to allow 51.8 44.3...
  • Page 30 The SAM 500P ECG arrhythmia analysis algorithm performance is summarised in the table below: 90% One- ECG Test Performance Performance Sided Lower Rhythm Class Sample Specifications Results (%) Confidence Size Limit Shockable rhythm: Ventricular fibrillation (VF) 2453 Sensitivity > 90% 93.48...
  • Page 31 The CPR Advisor Analysis Algorithm The following summary shows the results produced by the CPR component of the diagnostic algorithm, when run against the clinical database. The importance of administering effective chest compressions can mean the difference between a patient having a good quality of life following a cardiac arrest and having the misfortune of suffering neurological impairment due to inadequate cerebral oxygenation.
  • Page 32 CPR advisor to function correctly. For these reasons, CPR advisor is disabled when a paediatric Pad-Pak is used in the SAM 500P. Notice. The ECG readings, used to determine if the patient requires a defibrillation shock, are not affected by the electrode positions selected in paediatric patients.
  • Page 33 Guidance and manufacturer’s declaration – electromagnetic emissions The HeartSine Samaritan PAD with CPR-Advisor SAM 500P is intended for use in the electromagnetic environment specified below. The customer or user of the HeartSine Samaritan PAD with CPR-Advisor SAM 500P should assure that it is used in such an environment.
  • Page 34 Technical Data Guidance and manufacturer’s declaration – electromagnetic immunity The HeartSine Samaritan PAD with CPR-Advisor SAM 500P is intended for use in the electromagnetic environment specified below. The customer or user of the HeartSine Samaritan PAD with CPR-Advisor SAM 500P should assure that it is used in such an environment.
  • Page 35 Guidance and manufacturer’s declaration – electromagnetic immunity The HeartSine Samaritan PAD with CPR-Advisor SAM 500P is intended for use in the electromagnetic environment specified below. The customer or user of the HeartSine Samaritan PAD with CPR-Advisor SAM 500P should assure that it is used in such an environment.
  • Page 36 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location where the HeartSine Samaritan PAD with CPR-Advisor SAM 500P is used exceeds the applicable RF compliance level (see above), the HeartSine Samaritan PAD with CPR-Advisor SAM 500P should be observed to verify that it is operating normally.

  • Page 37: Voice Prompts

    Appendix A Voice prompts Adult Patient/Child Patient If a shock is not required… “Call for Medical Assistance” “No shock advised” “Remove Clothing from Patient’s Chest “Begin CPR” to Expose Bare Skin” “It Is Safe to Touch the Patient” “Pull ‘Green Tab’ to Remove Pads” “Place overlapping hands on centre of chest”...
  • Page 38 Appendix A If a shock is required… “Stand Clear of Patient – Shock Advised” “Stand Clear of Patient – Press the Orange Shock Button Now” “Shock Delivered “Begin CPR” “It Is Safe to Touch the Patient” “Place overlapping hands on centre of chest”...
  • Page 39 Notes...
  • Page 40 . h e a r t s i n e . c o m i n f o @ h e a r t s i n e . c o m US/Americas EMEA/ASP 0120 HeartSine Technologies, Inc. HeartSine Technologies. 121 Friends Lane, Suite 400 203 Airport Road West Newtown, PA. 18940...

Table of Contents

Save PDF