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PERIPHERAL NERVE STIMULATOR, monitoring (SunStim), electr.

https://unicat.msf.org/cat/product/71531
STD EANENESE2--

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CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
Z12101106 - Neurological stimulators
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
IIa
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
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The order of this product needs to be justified and is only acceptable under certain conditions.
OC subscriptions: included in supply or field order tools (e.g. UniField)
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PERIPHERAL NERVE STIMULATOR (SunStim)

Definition

An assembly of battery-powered devices designed to apply electrical stimuli to a peripheral nerve (e.g. the ulnar or lower extremity nerve) to assess the adequacy of neuromuscular block during surgery, and its reversal during the recovery period. The system typically uses four kinds of stimulation: twitch, train-of-four, tetanic, and double burst. It typically includes conventional electrocardiographic electrodes and/or bipolar surface electrodes (ball electrodes), and a pulse generator.

Specifications

Pulse generator for peripheral nerves to monitor the neuro-muscular block during surgical intervention.

  • Ball electrodes (8-1053-76)
  • 6' lead wire with clips (8-1051-79)
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Quality Standards Comment

See introduction on electro mechanical medical devices

Technical specifications

  • Stimulator output current adjustable from 0-70 mA
  • Switch functions:
    • Stand-by position: no stimulus pulses are generated
    • Twitch: 1 pulse per second
    • Tetanus: 100 Hz (100 pulses/s)
    • Built-in train of four: 4 pulses in a period of 2 seconds
  • LED (green) battery light indicates that the unit is on, flashes on low battery
  • LED (red) flashes with audible indicator sounds each time a stimulus pulse is generated
  • Battery
    • 9V alkaline battery
    • indicator light flashes when battery needs to be replaced
  • Power consumption: +/- 15.0 mA
  • Weigth: lightweight: 120 g/ 0.25lbs including battery
  • Dimensions: 95 x 57 x 25.4 mm

To be Ordered Separately

Pole mount bracket

Instructions for use

Use in operating theatre to monitor level of neuro-muscular block.

Use in Critical Care Unit to monitor level of neuro-muscular blockwhen indicated.

Precautions for Use

Use strictly limited to qualified staff.

Read carefully the user's manual of the manufacturer.

Maintenance

Cleaning and disinfection of the generator:

  • Use a detergent/disinfectant for surfaces/non-invasive medical equipment. Prepare use-solution in concentration required. Always read the label and product information before use. Do not mix with other products.
  • Make sure to wet the surfaces completely, use a wipe or towel, keep them wet for the whole exposure time.
  • Do not dry in sunlight.

MSF requirements

Intra-operative neuromuscular block monitoring is recommended when using neuromuscular blocking agents such as succinylcholine or atracurium, vecuronium

The PERIPHERAL NERVE STIMULATOR Stimuplex HNS12 (EANENESE1--) is intended for the localization of the nerves, whilst the Sunstim is to monitor the nerve block (grade of of the block)

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