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HeartSine samaritan PAD SAM 500P User Manual

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SAM 500P
User Manual

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Summary of Contents for HeartSine samaritan PAD SAM 500P

  • Page 1 HeartSine samaritan ® SAM 500P User Manual...

  • Page 2: Table Of Contents

    Contents Contents After use Indications for Use Pediatric-Pak Indications for use Service and Maintenance Contraindications for use Tracking Requirements Intended users Data Management Warnings and Cautions Troubleshooting Introduction Status indicator flashing red The SAM 500P Low battery warning Sudden cardiac arrest (SCA) Memory full warning Ventricular fibrillation Audible warnings...
  • 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: Indications For Use

    Indications for Use Indications for use Intended users The samaritan® PAD 500P is intended The HeartSine samaritan® PAD for use by personnel who have been 500P is indicated for use on victims of trained in its operation. Users should have...

  • Page 5: Warnings And Cautions

    Warnings and Cautions CPR Advisor is currently only intended to Warning provide feedback on adult patients. Do not delay treatment trying to find out Patients suitable for treatment the patient’s exact age and weight. The SAM 500P has been designed to work on unconscious, nonresponsive Risk of electric shock patients.
  • Page 6 Warnings and Cautions Avoid explosive or flammable Caution gases It has been determined that the SAM Correct placement of the electrode 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.
  • Page 7 Do not use if the pouch containing Notice the electrodes is not sealed The Pad-Pak is a single-use item and you Susceptibility to electromagnetic must replace it after each use or if the interference pouch that seals defibrillation pads has To safeguard against interference, you been broken or compromised in any way.
  • Page 8 Our algorithm uses heart rate variability as represent a commitment on behalf of one of its criteria for measuring ventricular HeartSine Technologies. No part of this fibrillation (VF). Consequently we do not manual may be reproduced or transmitted recommend the use of normal simulators in any form or by any means, electrical or to test our device.
  • Page 9 Check the device periodically. See ‘Service and Maintenance’ on page 22. Correct disposal of the device Dispose of the device in accordance with your national or local regulations, or contact your HeartSine distributor. Please follow the ‘After use’ on page 18.

  • Page 10: Introduction

    Introduction The SAM 500P The use of an external defibrillator within the first few minutes of collapse can The SAM 500P is a semi-automatic greatly improve patient’s chances of external defibrillator designed to quickly survival. Heart attack and SCA are not deliver a defibrillation shock to victims of the same, though sometimes a heart sudden cardiac arrest (SCA).

  • Page 11: Cpr Quality

    CPR Advisor feedback. professional responders regularly provide ineffective CPR due to inexperience. As Impedance cardiogram (ICG) a response to this problem, HeartSine The impedance cardiogram is a method has developed the SAM 500P with of measuring changes in the patient’s CPR-Advisor.

  • Page 12: Recommended Training

    Use the metronome as a guide on how To properly diagnose this condition, frequently to compress a patient’s chest if HeartSine recommends that all potential you need to apply CPR. users of the SAM 500P are fully trained in cardiopulmonary resuscitation (CPR),...

  • Page 13: Sam 500P Overview

    SAM 500P Overview Attach pads icon Status indicator Data port The action arrows around this When the indicator is icon will flash to instruct you flashing green the SAM to attach the electrode pads to 500P is ready for use. Shock button the patient as indicated.

  • Page 14: Preparation

    Preparation Unpacking Checks before putting into service Check that the contents include the User 1. Check the expiry date (year/month) Manual, soft case, Pad-Pak, guarantee on the rear of the Pad-Pak (see card and Emergency User Guide. the illustration below). If the expiry date has passed, you must replace A Pad-Pak is a single-use removable the Pad-Pak.
  • Page 15 4. Turn on the SAM 500P by pressing packaging in case you need to return on the front panel to check that the Pad-Pak to HeartSine. Place the the device is operating correctly. SAM 500P on a flat surface. Insert...

  • Page 16: Preparation Checklist

    22). with your SAM 500P. You can store it in the rear section of the soft carry case. 7. Complete the guarantee card and return it to your authorised distributor or HeartSine Technologies directly (see ‘Tracking Requirements’ on page 23).

  • Page 17: Using The Sam 500P

    Using the SAM 500P When to use Using the SAM 500P The SAM 500P is indicated for use on Refer to the separate Emergency User victims of sudden cardiac arrest who are Guide. During use the SAM 500P will give exhibiting the following signs: extensive voice prompts to guide a user.

  • Page 18: After Use

    Using the SAM 500P After use Do not dispose of the SAM 500P or Pad-Pak in the normal waste. 1. Turn off the SAM 500P by pressing Dispose of it at an appropriate on the front panel. recycling facility according to local requirements.
  • Page 19 5. Check the SAM 500P for damage. If the SAM 500P is damaged, replace it immediately. 6. Install a new Pad-Pak. Before installing, check the Pad-Pak expiry date (see ‘Preparation’ on page 14). After installation check the status indicator is blinking green.

  • Page 20: Pediatric-Pak

    Pediatric-Pak Using the Pediatric-Pak Electrode Placement: For pediatric patients there are two options The Pediatric-Pak is intended to provide for electrode placement: therapy for pediatric (child) victims of SCA between the ages of 1 and 8 years a. If a child’s chest is small it may be old who are: necessary to place one pad on the child’s BARE chest in the center, and the other...
  • Page 21 b. If a child’s chest is large enough to Warning: Defibrillation permit a 1 inch (2.5cm) gap between the electrodes must be at least pads, pad placement can be used similar 1 inch (approx 2.5 cm) apart to adult placement. Place one pad on and should never be touching child’s BARE upper right chest above one another.

  • Page 22: Service And Maintenance

    If the date has expired, or is near expiry, replace with a new Pad-Pak or contact your local HeartSine distributor for a replacement. 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, read the section ‘Troubleshooting’...

  • Page 23: Tracking Requirements

    Name Address Device serial number or use our on-line registration tool at https://secure.heartsine.com/UserRegistration.html Your participation will allow us to contact you with any important notifications about the SAM 500P, such as any future software updates or field safety corrective actions.

  • Page 24: 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 25: Troubleshooting

    If you hear this SAM 500P by pressing on the front message, contact HeartSine Technologies panel and listen for the voice prompt technical support. illate ‘call for medical assistance’. Then turn...

  • Page 26: Device Service Required

    Troubleshooting 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 27: 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 (32 to 122 °F) Transport temperature: -10 to 50 °C (14 to 122 °F) for up to two days.
  • Page 28 Technical Data Pad-Pak and Pediatric-Pak Weight: 0.2 kg (0.44 lbs) Battery type: Disposable single-use combined battery and defibrillation electrode cartridge (lithium manganese dioxide (LiMnO ) 18V) Battery capacity (new): >60 shocks Battery capacity (4 years): >10 shocks Standby life: See the expiry date on the Pad-Pak. Electrode type: Single-use pre-attached combined ECG sensor/ defibrillation pad...
  • Page 29 Extensive voice prompts guide the user through the operation sequence (see ‘List of Voice Prompts’ on page 41). 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 150J in <...
  • Page 30 Event recording Type: Internal memory Memory: 90 minutes of ECG (full disclosure) and event/ incident recording Review: Custom USB cable directly connected to a PC and Saver™ EVO Windows-based data review software Electromagnetic compatibility EMC: IEC60601-1-2 Radiated Emissions: IEC55011 Electrostatic Discharge: IEC61000-4-2 (8 kV) RF Immunity: IEC61000-4-3 80 MHz –...
  • Page 31 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 1000 -1 0 230 ohms.
  • Page 32 Technical Data Arrhythmia analysis algorithm Waveform Waveform Voltages Duration The SAM 500P uses the HeartSine Energy Resistance (volts) (ms) samaritan ECG arrhythmia analysis ® (ohms) (joules) Tilt algorithm. This algorithm will evaluate the patient’s ECG to ascertain if a therapeutic 47.5...
  • Page 33 The SAM 500P ECG arrhythmia analysis algorithm performance is summarised in the table below: ECG Test 90% One- Required Sample Performance Sided Lower Rhythm Class Performance Size Results (%) Confidence Specifications (seconds) Limit Shockable Rhythm: 13341 Sensitivity > 90% 96.97 96.72 Ventricular Fibrillation (VF) Shockable Rhythm:...
  • Page 34 Technical Data 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 35 Paediatric restriction Use of the CPR-Advisor function must be restricted to adult patients only. Chest compression techniques differ for the different ages and sizes of paediatric patients (up to eight years old). For younger paediatric patients, rescuers should compress the lower half of the sternum but not compress over the xiphoid.
  • Page 36 Technical Data Guidance and manufacturer’s declaration – electromagnetic emissions The SAM 500P is intended for use in the electromagnetic environment specified below. The customer or user of the SAM 500P must assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –...
  • Page 37 Guidance and manufacturer’s declaration – electromagnetic immunity The SAM 500P is intended for use in the electromagnetic environment specified below. The customer or user of the SAM 500P must assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance Electromagnetic environment...
  • Page 38 Technical Data Guidance and manufacturer’s declaration – electromagnetic immunity The SAM 500P is intended for use in the electromagnetic environment specified below. The customer or user of the SAM 500P must assure that it is used in such an environment. IEC 60601 Compliance Immunity test...
  • Page 39 Guidance and manufacturer’s declaration – electromagnetic immunity ... compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol: Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations.
  • Page 40 Technical Data Recommended separation distances between portable and mobile RF communication equipment and the SAM 500P The SAM 500P is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the SAM 500P can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SAM 500P as recommended below, according to the maximum output power of the communications equipment.

  • Page 41: List Of Voice Prompts

    List of Voice Prompts If a shock is not required… Listed below are the voice prompts used by the SAM 500P. Read the voice prompts “No shock advised” in advance of use to be familiar with the “Begin CPR” types of instructions given. “It is safe to touch the patient”...
  • Page 42 Notes...
  • Page 44 . 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...

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