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HeartSine SAM300P User Instructions

Pediatric-pak for use with the samaritan pad
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Your Safety Company
800-548-3920
Pediatric-Pak User Instructions
(For Use with the samaritan® PAD Model SAM300P)
CAUTION: Federal (U.S.) law restricts this device to sale by or on the order of a licensed practitioner.
H023-001-009-8

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Summary of Contents for HeartSine SAM300P

  • Page 1 Your Safety Company 800-548-3920 Pediatric-Pak User Instructions (For Use with the samaritan® PAD Model SAM300P) CAUTION: Federal (U.S.) law restricts this device to sale by or on the order of a licensed practitioner. H023-001-009-8...

  • Page 3: Indications For Use

    samaritan® Pediatric-Pak User Instructions INDICATIONS FOR USE: The samaritan® Pediatric-Pak (Model SPP 351) is indicated for use to treat patients in cardiopulmonary arrest who are unconscious, without a pulse and not breathing spontaneously. They should only be used by personnel who have been trained in its operation.
  • Page 4 samaritan® Pediatric-Pak User Instructions This device is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support and use of AEDs’, advanced life support, or a physician-authorized emergency medical response training program. Your Pediatric-Pak contains a magnetic component (surface strength 4500 gauss).
  • Page 5 Refer to the samaritan® PAD User Manual for comprehensive information on how to operate the defibrillator. Note that the Pediatric-Pak gives the capability to use the samaritan® PAD (Model SAM300P) on children. When used this patient group is no longer contraindicated with the samaritan® PAD.
  • Page 6 samaritan® Pediatric-Pak User Instructions Electrode Placement: 1. Due to the smaller size of a pediatric victim, there are two options for electrode placement: a. If a child’s chest is small it may be necessary to place one pad on the child’s BARE chest in the center, and the other pad on the child’s BARE back in the center of the ribcage.
  • Page 7 samaritan® Pediatric-Pak User Instructions Specifications Waveform: Biphasic Truncated Exponential PAD impedance range: 0 – 176 Energy Accuracy: 50J ±15% Impedance, Energy, J 47.4 51.3 52.1 51.8 52.4 Samaritan PAD Resistance Waveform Voltages (Volts) Waveform Duration (msec) (Ohms) Tilt % 55.6 50.4 47.1 10.0...
  • Page 8 Summary of Clinical Studies: ECG Analysis Detection System (EADS) The HeartSine samaritan® EADS has been tested using a database of a broad range pediatric and adult patients ECG exhibiting shockable and non-shockable rhythms. The results for pediatric analysis indicate that the samaritan EADS properly detects shockable and non-shockable rhythms with a sensitivity of 100.00 % and a Specificity of 100.00 %.
  • Page 10 Sales U.S. Worldwide Headquarters: Manufactured by: Your Safety Company HeartSine Technologies Inc HeartSine Technologies, Ltd 105 Terry Drive 203 Airport Road West 111 Quarry Road Newtown Belfast, BT3 9ED Pennsylvania, PA 18940 Northern Ireland Chambersburg PA 17202 Tel: 1.215.860.8100 Tel: +44 (0)28 9093 9400 Fax: 1.215.860.8192...