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PERIPHERAL NERVE STIMULATOR (Stimuplex HNS12), electrical

https://unicat.msf.org/cat/product/12540
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Former Code(s): EANENERS1--
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.
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In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
PM
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)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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Documents

NERVE STIMULATOR (Stimuplex HNS12)

Definition

The electrical stimulation of peripheral nerves facilitates the atraumatic performance of regional anaesthesia blocks.

This technique allows the localisation of nerve plexuses and peripheral nerves with a motor component. During injection of local anaesthetics, the immediate simultaneous disappearance of the motor response helps to confirm the right position of the needle.

The nerve stimulator is used by anaesthetists.

Specifications

Stimulator for the pre-operative localisation of peripheral nerves.

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Quality standards

EN 60601-2-10, 2015, +A1 2016 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

Quality Standards Comment

See introduction on electro mechanical medical devices

Technical specifications

  • Stimuplex HNS 12 generates square pulses with selectable stimulus duration and continuously adjustable stimulation current.
  • The current control display enables the following adjustments
    • The range of adjustment of the pulse current from 0 to 5 mA can be reduced to 0 to 1 mA with the ”mA” button
    • This 1 mA range allows extremely precise adjustments of the stimulation current
  • Current range intensity :
    • 0.00 – 5.00 mA
    • 0.00 – 1.00 mA
  • Stimulation frequency: 1 Hz / 2 Hz
  • Stimulus duration of 0.05 ms – 0.10 ms – 0.30 ms – 0.50 ms – 1.00 ms ± 1%
  • Impedance of eligible load : 0 – 12 Ω
  • Precision of the current measure : ± 0,02 mA 1 Ω– 90 Ω for a target current > 0,5 mA

Dimensions

  • Weight 250 g
  • Length 16 cm, Width 8 cm

Packaging & Labelling

Unit packaging

Dimensions box: Length 33 cm, Width 40 cm

Supplied with the Article

Stimuplex® HNS 12 is supplied with the following basic equipment:

  • nerve stimulator Stimuplex HNS 12
  • 9-volt alkaline manganese battery
  • cable for connecting B. Braun stimulation needles (cable length 1.25 m)
  • 10 kΩ test resistance
  • electronic version of user manuals in different languages
  • brief instructions for use
  • storage case for keeping Stimuplex HNS 12 and accessories

To be Ordered Separately

Echogenic needles Stimuplex Ultra 360: 20 or 22G

Instructions for use

Use strictly limited to qualified staff.

Read carefully the user's manual of the manufacturer.

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Precautions for Use

  • The nerve stimulator is intended only for the pre-operative localization of nerves; under no circumstances may it be used on a patient undergoing surgery.
  • The nerve stimulator should not be used on patients with implanted electrical devices (e.g. cardiac pacemakers) without prior consultation with an appropriate medical specialist.
  • To avoid damage to the connecting cable and the device, do not hold or carry the device by its connecting cables and/or its accessories. Do not wrap the cable around the device or around other equipment.
  • Under no circumstance should the device be operated with accessories other than those released and supplied by the manufacturer or listed in the user's manual.

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.
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