Idmed Algiscan, User Manual

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User Manual AlgiScan 6
Important information about the use of AlgiScan
The AlgiScan compact video pupillometer is designed to be used by an authorised health
professional (anaesthetist, medical doctor or state registered nurse, anaesthetist nurse)
who has received special training in its use. The system, and all associated parameters, are
designed to be used on adult and paediatric patients in a hospital or health care facility to
monitor the responsiveness of their pupils to various stimuli.
The measurements performed by the AlgiScan on the pupillary reactivity of the patient can be
used to monitor the effects of certain anaesthetic products.
The interpretation of the results provided by the AlgiScan should always be subjected to
clinical judgement and compared with other clinical signs observed. We strongly advise
against relying solely on the results or values provided by the AlgiScan for monitoring sedated
or anaesthetised patients. The values provided by the AlgiScan should also be interpreted
with care when in the presence of certain products such as Barbiturate, Nitrous oxide, etc. It is
also necessary to interpret with care values measured on patients suffering from neurological
problems.
The AlgiScan conforms to the European directive covering medical devices and to the
regulations in force in the country of distribution.
For further information please contact IDMED, the manufacturer of the AlgiScan via their
website WWW.IDMED.FR or by post to the following address:
IDMED
Hôtel Technoptic
2 rue M. DONADILLE
13013 MARSEILLE
FRANCE
Phone : +33 (0)4.91.11.87.84
I Safety measures
INTRODUCTION
The user must read carefully the whole manual before operating the AlgiScan.
WARNING, CAUTION, NOTES
The terms Warning, Caution and Notes have precise meanings in this manual.
• WARNING warns against certain actions or situations likely to cause injury or death.
• CAUTION warns against actions or situations likely to damage the equipment, produce
inaccurate data or cancel a procedure, even if injury is unlikely.
• A NOTE provides useful information about a function or procedure.
EXPLANATION OF SYMBOLS
The symbols that may appear on the AlgiScan display are compiled and explained at the end
of this chapter.
Any serious incident occurring in connection with the device must be notified to the manu -
facturer and to the competent authority of the Member State or country in which the user and
the patient are established.