Osicus User Guide V8
09/09/2021
Page
7
of
46
CAUTIONS
Federal (USA) law restricts this device to sale by or on the order of a physician.
The use of the Osicus near to sources of electromagnetic radiation, such as mobile
phones, radio transmitters, x-ray equipment etc, may prevent it from functioning
correctly. Appendix 1 provides guidance on the Electromagnetic environment in which to
operate the instrument.
This is a medical instrument, which has an electrical classification of Class 1 Type B and a
Medical Device Directive classification of Class IIa.
A Class 1 Type B device categorisation is used to describe an instrument which:-
a) Does not rely on basic insulation only to provide protection against electrical shock but
is constructed in such a way that accessible metal parts cannot become live in the event
of failure of the basic insulation and
b) Applied parts offer protection to the subject against electrical shock and in the event of
a single fault condition arising, leakage current will be limited to less than 0.5 mA.
Any incident, which results in actual or potential injury or death to a subject while using
the Osicus should be immediately communicated to GM Instruments at the address
below.
The Osicus should only be connected to other mains powered devices such as computers
and printers, which comply with EN 60950-1 and we also advise the use of a separating
transformer. Unless computers and printers built to EN 60950 are used, patient safety
might be compromised.
Non-medical equipment such as computers and printers should be kept out of reach of
subjects being tested as such equipment does not comply with medical safety standards.
Refer to clause 16 of EN 60601-1:2006 to ensure compliance.
If the PC is allowed to go in to sleep mode, the USB interface is powered down. When
brought out of sleep mode, the PC does not re initialise the USB interface, and therefore it is
effectively not present. A solution is to remove the USB connection at the PC or instrument
side then re connect. That may be sufficient, but if not, save any results, then close down the
instrument software and restart it
Servicing can only be carried out by GMI approved and
authorised personnel. No modifications are allowed
.
