Osicus User Guide V8
09/09/2021
Page
44
of
46
Appendix 2: Technical Information (relative to EN 60601-
1:2006+A12:2014)
No modification to this equipment is allowed
.
6.2
The Osicus Audiometer is powered from a laptop or PC via the supplied USB cable. Power can
be removed by unplugging the USB cable from either the PC/laptop or the back of the Osicus.
It complies with the specification for Class 1 ME equipment, and can be used along with a PC and
printer, normally supplied by the customer. NB the warning made earlier about the PC and printer
being compliant with EN 60950 and placing these items out of the reach of a subject.
The Applied Parts comprise, Right and Left Headset and the Response Button, which are classified
as type B applied part.
The Applied Parts (headphones and response switch) are the only parts used in the patient
environment.
The laptop/PC are used in the non-patient environment.
6.3
The enclosure does not provide protection against the ingress of liquids and is therefore
classified as IPX0. The supplied PSU enclosure does not provide protection against the ingress of
liquids but does have level 2 degree of protection and is rating IP20.
6.4
There are no parts which are supplied sterile or are required to be sterile.
6.5
The Osicus Audiometer is
NOT
suitable for use in an oxygen rich environment.
6.6
The Osicus Audiometer is rated for continuous use.
7.2.2
The Osicus serial number can be found on the label on the back panel, and the software
version number can be viewed on the start-up screen and by clicking on Help, found on the top
bar of the software (when fitted)
7.2.3
Information is given in the Warning and Caution section of this manual, which the user must
read prior to operating this instrument. Appropriate labels are fixed to the back panel
7.2.4
The Headset and Response Button are identified as accessories with part numbers
7.2.5
The Osicus power is intended to receive power via a USB connection with a ISO 60950
compliant laptop/PC. The USB connection is marked with ISO 7010-M002 safety sign.
7.2.6
The Osicus power supply module, provides DC voltages of 9 volts dc from an input which can
range from 100 to 240 volts, AC at 50 to 60 Hz.
7.2.11
The Osicus Audiometer is rated for continuous use.
