HeartSine samaritan PAD SAM 300P User Manual
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HeartSine samaritan PAD SAM 300P User Manual

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HeartSine samaritan PAD
SAM 300P
User Manual

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Summary of Contents for HeartSine samaritan PAD SAM 300P

  • Page 1 HeartSine samaritan PAD SAM 300P User Manual...

  • Page 2: Table Of Contents

    Contents Contents Service and Maintenance Warnings and Cautions Tracking Requirements Introduction Data Management The HeartSine samaritan PAD SAM 300P 9 Troubleshooting Sudden Cardiac Arrest (SCA) Status indicator flashing red Ventricular fibrillation Low battery warning Recommended training Memory full warning CPR metronome...
  • 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

    Warnings and Cautions Risk of electric shock Warning The SAM 300P delivers therapeutic electrical shocks that can cause serious Patients suitable for treatment harm to either operators or bystanders. The SAM 300P has been designed to Take care to ensure that nobody touches work on unconscious, nonresponsive the patient when a shock is to be patients.
  • Page 5 Avoid explosive or flammable Caution gases It has been determined that the SAM Correct placement of the electrode 300P is safe to use with oxygen mask pads delivery systems. However, to avoid Proper placement of the SAM 300P’s the risk of an explosion, it is strongly electrode pads is critical.
  • Page 6 Warnings and Cautions 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 pouch interference that seals defibrillation pads has been To safeguard against interference, you broken or compromised in any way.
  • Page 7 Standby storage outside the range of 0 ºC carefully before using the HeartSine to 50 ºC may decrease the shelf-life of Samaritan PAD SAM 300P. This manual the device. is presented in support of any training you may have received. If you have...
  • Page 8 Check the device periodically. See ‘Service and Maintenance’ on page 18. Correct disposal of the device Dispose of the device in accordance with the European WEEE Directive, or contact your HeartSine distributor. Please follow the ‘After use’ on page 16.

  • Page 9: Introduction

    (CPR). 300P The use of an external defibrillator within the first few minutes of collapse can The HeartSine Samaritan PAD SAM 300P greatly improve patient’s chances of is a semi-automatic external defibrillator survival. Heart attack and SCA are not...

  • Page 10: Recommended Training

    To properly diagnose this condition, performing compressions. HeartSine recommends that all potential users of the SAM 300P are fully trained in cardiopulmonary resuscitation (CPR), basic life support (BLS) and, in particular, the use of an automated external defibrillator.

  • Page 11: Sam 300P Overview

    SAM 300P 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 300P is ready for use. Shock button the patient as indicated.

  • Page 12: 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 13 Turn on the SAM 300P by pressing packaging in case you need to return the the front panel. To check that the device is Pad-Pak to HeartSine. Insert the Pad-Pak operating correctly, listen for appropriate into the SAM 300P (see the illustration voice prompts and make sure that no below).

  • Page 14: Guidelines For Storage

    SAM 300P. You can store it in the rear section of the soft carry case. Register your SAM 300P Complete the guarantee card and return it to your authorised distributor or HeartSine Technologies directly (see ‘Tracking Requirements’ on page 19).

  • Page 15: Using The Sam 300P

    Using the SAM 300P When to use Using the SAM 300P The HeartSine Samaritan PAD SAM 300P Refer to the separate Quick Start Guide. is indicated for use on victims of sudden During use the SAM 300P will give cardiac arrest who are exhibiting the extensive voice prompts to guide the user.

  • Page 16: After Use

    Using the SAM 300P After use Do not dispose of the SAM 300P or Pad- Pak in the normal waste. Dispose of it at Turn off the SAM 300P 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 the replacement.
  • Page 17 Check the SAM 300P for damage. If the SAM 300P is damaged, replace it immediately. Install a new Pad-Pak. Before installing, check the Pad-Pak expiry date (see ‘Preparation’ on page 12). After installation check the status indicator is blinking green.

  • Page 18: Service And Maintenance

    Service and Maintenance HeartSine recommends users perform regular maintenance checks. A suggested maintenance check would be: Weekly 1. Check the status indicator. If the green status indicator is not flashing approximately every 5 seconds, a problem has been detected. See ‘Troubleshooting’...

  • Page 19: Tracking Requirements

    The Medical Devices Regulations require us to track the location of all medical devices sold. It is important that you complete the warranty card with your details and return it to your authorised distributor or HeartSine Technologies directly. Alternativley please send an email to support@heartsine.com containing the following information: Name Address Device serial number or use our on-line registration tool at https://secure.heartsine.com/UserRegistration.html...

  • Page 20: 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 Saver™ authorised distributor or HeartSine EVO utility. Technologies directly about the After-Use Data Management Service.

  • Page 21: Troubleshooting

    If you hear this message, contact prompt ‘call for medical assistance’. Then HeartSine Technologies technical support. turn off by pressing on the front panel. If this action does not correct the problem,...

  • Page 22: 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 23: 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 24 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 25 Electrodes Type: Single-use pre-attached combined ECG 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 26 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 27 SCOPE™ Biphasic Waveform 2000 The SAM 300P 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 28 Technical Data Arrhythmia analysis algorithm Waveform Waveform Voltages Duration The SAM 300P 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 29 The SAM 300P 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 90.58 ventricular tachycardia (VT)
  • Page 30 Guidance and manufacturer’s declaration – electromagnetic emissions The HeartSine Samaritan PAD SAM 300P is intended for use in the electromagnetic environment specified below. The customer or user of the HeartSine Samaritan PAD SAM 300P should assure that it is used in such an environment.
  • Page 31 Guidance and manufacturer’s declaration – electromagnetic immunity The HeartSine Samaritan PAD SAM 300P is intended for use in the electromagnetic environment specified below. The customer or user of the HeartSine Samaritan PAD SAM 300P should assure that it is used in such an environment.
  • Page 32 Guidance and manufacturer’s declaration – electromagnetic immunity The HeartSine Samaritan PAD SAM 300P is intended for use in the electromagnetic environment specified below. The customer or user of the HeartSine Samaritan PAD SAM 300P should assure that it is used in such an environment.
  • Page 33 PAD SAM 300P is used exceeds the applicable RF compliance level (see above), the HeartSine Samaritan PAD SAM 300P should be observed to verify that it is operating normally. If abnormal operation is observed, additional measures may be necessary, such as re-orienting or relocating the HeartSine Samaritan PAD SAM 300P.

  • Page 34: 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 35 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” “Press down in time with the metronome”...
  • Page 36 . 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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