HeartSine samaritan PAD 450P User Manual
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HeartSine samaritan PAD 450P User Manual

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SAM 450P
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Summary of Contents for HeartSine samaritan PAD 450P

  • Page 1 samaritan PAD 450P ® SAM 450P User Manual...

  • Page 2: Table Of Contents

    Contents Contents Pediatric-Pak Indications for Use Service and Maintenance Indications for use Tracking Requirements Contraindications for use Data Management Intended users Troubleshooting Warnings and Cautions Status indicator flashing red Introduction Low battery warning The SAM 450P Memory full warning Sudden cardiac arrest (SCA) Audible warnings Ventricular fibrillation Device service required...
  • Page 3 Symbols used in this manual Does not contain natural rubber latex Warning: Risk of death or Non-sterile serious injury Recyclable Non-rechargeable battery Caution: Risk of injury Do not short circuit battery Notice: Risk of damage to Do not crush battery data or material Temperature limitation as indicated Further information...

  • Page 4: Indications For Use

    Without circulation • US Federal law restricts this device to sale The samaritan PAD 450P is indicated for by or on the order of a physician. use on patients greater than 8 years old or over 55 lbs (25 kg) when used with the adult samaritan Pad-Pak™...

  • Page 5: Warnings And Cautions

    Warnings and Cautions CPR Rate Advisor is currently only Warning intended to provide feedback on adult patients. Patients suitable for treatment Do not delay treatment trying to find out The SAM 450P has been designed to work the patient’s exact age and weight. on unconscious, unresponsive patients.
  • Page 6 Warnings and Cautions Avoid explosive or flammable Caution gases It has been determined that the SAM Correct placement of the electrode 450P is safe to use with oxygen mask pads delivery systems. However, to avoid Proper placement of the SAM 450P 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 authorized distributor. Please follow the ‘After use’ on page 18.

  • Page 10: Introduction

    Introduction The SAM 450P The use of an external defibrillator within the first few minutes of collapse can The SAM 450P 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 Rate Advisor

    CPR but receives no professional responders regularly provide CPR Rate Advisor feedback. ineffective CPR due to inexperience. As a response to this problem, HeartSine Impedance cardiogram (ICG) has developed the SAM 450P with CPR The impedance cardiogram is a method Rate 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 450P are fully trained in cardiopulmonary resuscitation (CPR),...

  • Page 13: Sam 450P Overview

    SAM 450P Overview Attach pads indicator 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 450P 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 expiration date (year- Manual, soft case, Pad-Pak, Registration month-day) on the rear of the Pad- and Warranty Card and Emergency Pak (see the illustration below). If the User Guide.
  • Page 15 4. Turn on the SAM 450P 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 450P on a flat surface. Insert...

  • Page 16: Preparation Checklist

    SAM 450P. You can on page 22). store it in the rear section of the soft carry case. 7. Complete the Registration and Warranty Card and return it to your authorized or HeartSine Technologies directly (see ‘Tracking Requirements’ on page 23).

  • Page 17: Using The Sam 450P

    Using the SAM 450P When to use Using the SAM 450P The SAM 450P is indicated for use on Refer to the separate Emergency User victims of sudden cardiac arrest who are Guide. During use the SAM 450P will exhibiting the following signs: give extensive voice prompts and LED indications to guide a user.

  • Page 18: After Use

    Using the SAM 450P After use Do not dispose of the SAM 450P or Pad-Pak in the normal waste. 1. Turn off the SAM 450P by pressing Dispose of it at an appropriate on the front panel. recycling facility according to local requirements.
  • Page 19 5. Check the SAM 450P for damage. If the SAM 450P is damaged, replace it immediately. 6. Install a new Pad-Pak. Before installing, check the Pad-Pak expiration 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 1 inch (approx 2.5 cm) apart pads, pad placement can be used similar 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

    14 for the location of the date). If the date has expired, or is near Weekly expiration, replace with a new Pad- Pak or contact your local HeartSine Check the status indicator. If the authorized distributor for a replacement. green status indicator is not flashing...

  • Page 23: Tracking Requirements

    SAM 450P, contact us with the updated It is important that you complete the information. Registration and Warranty Card with your details and return it to your authorized distributor or HeartSine Technologies directly. Alternatively send an email, to support@ heartsine.com, containing: Name...

  • Page 24: Data Management

    Data Management The HeartSine Saver EVO software 2. Connect the USB cable to a PC. ® is an optional accessory. Contact your 3. Launch the HeartSine authorized distributor or HeartSine Saver EVO utility. Technologies directly about the after-use data management service.

  • Page 25: Troubleshooting

    SAM 450P by pressing on the contact HeartSine Technologies technical front panel and listen for the voice prompt support. Alternatively, use the HeartSine ‘call for medical assistance’. Then turn Saver EVO software to clear the memory off by pressing on the front panel.

  • Page 26: Device Service Required

    Troubleshooting Device service required Warranty exclusion If the device plays the message ‘device HeartSine or its authorized distributors service required’, then it has detected a are not obliged to replace or repair under fault. Contact your authorized 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: 8.0 in x 7.25 in x 1.9 in (20 cm x 18.4 cm x 4.8 cm) Weight: 2.4 lbs (1.1 kg) Environmental Operating temperature: 32 °F to 122 °F (0 °C to 50 °C) Standby temperature: 32 °F to 122 °F (0 °C to 50 °C) Transport temperature:...
  • Page 28 Technical Data Pad-Pak and Pediatric-Pak Weight: 0.44 lbs (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 200 J or 6 hours of continuous monitoring Battery capacity (4 years): >10 shocks at 200 J Standby life: See the expiration date on the Pad-Pak.

  • Page 29: User Interface

    Extensive voice prompts guide the user through the operation sequence (see ‘List of Voice Prompts’ on page 41) Languages: Contact your HeartSine authorized 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 Event 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:...
  • Page 31 SCOPE Biphasic Waveform 2000 The SAM 450P delivers a Self 1000 Compensating Output Pulse Envelope (SCOPE) biphasic waveform. This Volts waveform automatically optimizes 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 450P uses the HeartSine Resistance Energy (volts) (ms) samaritan ECG arrhythmia analysis (joules) (ohms) Tilt algorithm. This algorithm will evaluate the patient’s ECG to ascertain if a therapeutic 47.5 55.6...
  • Page 33 The SAM 450P ECG arrhythmia analysis algorithm performance is summarized in the table below: 90% Lower Total Blocks Required Rhythm Class Results (%) Confidence (seconds) Performance Limit Shockable Rhythm: 14538 Sensitivity > 90% 97.03 95.31 Ventricular Fibrillation (VF) Shockable Rhythm: 2321 Sensitivity >...
  • Page 34 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 35 Pediatric restriction Use of the CPR Rate Advisor function must be restricted to adult patients only. Chest compression techniques differ for the different ages and sizes of pediatric patients (up to eight years old). For younger pediatric 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 450P is intended for use in the electromagnetic environment specified below. The customer or user of the SAM 450P 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 450P is intended for use in the electromagnetic environment specified below. The customer or user of the SAM 450P 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 450P is intended for use in the electromagnetic environment specified below. The customer or user of the SAM 450P 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 450P The SAM 450P is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the SAM 450P can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SAM 450P 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… Some of the voice prompts used by the SAM 450P are listed below. Read the “No shock advised” voice prompts before you use the SAM “Begin CPR” 450P so you are familiar with the types of “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 EMEA/APAC US/Americas HeartSine Technologies, Ltd. HeartSine Technologies, Inc. 203 Airport Road West 121 Friends Lane, Suite 400...

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