Overview; Intended Use; Warnings; Check Of The Functioning - vygon Plexygon Manuel De L'utilisateur

1. OVERVIEW

This device is manufactured according to current International safety standards .
Please carefully read the following warnings, instructions and safety information
before using the device as recommended by the symbol
device .
1.1

Intended use

Plexygon is an electronic medical device aimed to provide the anaesthetist,
practising peripheral anaesthesia or pain therapy, with an instrument allowing an
easier and more precise localisation of the nerve . Nerve location is achieved by
generating an appropriate electrical stimulation, through a dedicated needle-
electrode, then inducing a muscular reaction on the afferences of the nerve
reached by the stimulation . The PLEXYGON stimulator has been designed to
obtain the best performances in term of reliability, user friendliness, efficacy and
safety .

1.2 Warnings

The warning notes are marked along the following paragraphs by the
symbol

Check of the functioning

- If Plexygon is not working as described in this manual, don't use the device
and call for technical assistance .
- The user must make sure that the device is safe and integral before using it .
Carry out verifications as specified (see paragraph 3.2).
- If at the time of switching on the display is any different from what is
described, the stimulator is not suitable for the use .
- If the symbol of battery is blinking, this means that the battery is not charged
enough and must be changed .
Use of the stimulator
- The stimulator must be used by qualified personnel and only after completely
reading the enclosed manual of instructions for use . These personnel must
also have a sound knowledge of anatomy and neuro-physiology, and
knowledge of the protocols in force for the execution of peripheral blocks
(see paragraph 3.1).
- The injection of anaesthetic drugs causes a variation of the nerve response
to the stimulation; therefore after the injection it will not be possible to
maintain the stimulation at the same levels of current . - Always
aspiration of blood before any injection .
- Using lower charge allows further precision but implies higher risks of direct
contact with the nerve .
- If the sound tone has been deactivated, check the display to make sure that
the current is effectively supplied to the patient (see par. 2.7.2).
- Since the device is not supposed to be sterile, do not bring it in a sterile field
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printed on the
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