Idmed Algiscan, Руководство пользователя

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User Manual AlgiScan 5
About this manual
This operating manual contains all the information necessary to set up and use the
portable pupillometer AlgiScan manufactured by IDMED. It also describes the specific cleaning
and checking procedures that you may need to perform. This manual is intended for use by
qualified medical personnel only (state registered nurses, anaesthetists and doctors).
Keep this operating manual with the AlgiScan. It serves as a maintenance and repair manual.
Read the safety information in this manual carefully before using the AlgiScan.
Indications of use
The AlgiScan is a portable video pupillometer, intended to:
- Measure patients’ pupils quickly and easily,
- Evaluate the pupillary light reflex of the patient following a photo-stimulation
- Evaluate nociceptive responses and the extent of analgesic response following an electrical
stimulation, in patients in the operating theatre, in recovery or in critical care
These patients are sedated and unable to communicate.
The usage mode for this device in non-continuous.
It provides the user with reliable, accurate and reproducible measurements. In a few
seconds the user has access not only to the measurement of the pupil diameter, but also
to the characteristics of its dynamic evolution: minimum, maximum, latency and speed of
evolution.
The size and reactivity of the pupil are considered as supplementary data which provide
more precise information on the analgesic condition and hypnotic state of the patient and his
pupillary light reflex.
The use of AlgiScan allows to adjust the sedation dosage without replacing the usual practice
(clinical or pharmacological).
Two parts of the Algiscan may be in contact with the patient: the stimulation cable via the
appropriate electrodes and the eyecup.
Expected performance
The following features are the essential performance characteristics of the AlgiScan:
- Measure the average diameter of a patient’s pupil to an accuracy of +/- 0.1 mm (simulated
pupil of 3 mm diameter).
- Generate a white light stimulation with an intensity of 320 lux +/- 10%, and a duration of
1 sec +/- 0.1 sec.
- Generate electrical skin stimulation in the form of pulse train of 200μs, 100Hz, with an
amplitude between 0 and 60mA and a total duration between 0 and 8s.
Its characteristics are produced with an accuracy of +/- 10%.
Clinical Benefits
The clinical benefits of the AlgiScan are:
- A measurement of the patient’s analgesia level using their pupillary dilation reflex.
- A precise measurement of the pupillary dilatation reflex.
- A reproducible and quantitative measurement of the photomotor reflex (Pupil Light Reflex)
in neurological assessment.