2.3.6 Environmental Factors - Interacoustics OtoRead Instructions For Use Manual

2.3.6 Environmental factors

CAUTION
D-0116684-B – 2020/03
OtoRead™ - Instructions for Use - US
Interacoustics will make available on request circuit diagrams, component
part lists, descriptions, calibration instructions, or other information that will
assist authorized service personnel to repair those parts of this instrument
that are designated by Interacoustics as repairable by service personnel.
No parts of the equipment can be serviced or maintained while in use with
the patient.
Connect only accessories purchased from Interacoustics to the instrument.
Only accessories which have been stated by Interacoustics to be compatible
are allowed to be connected to the device.
Never insert, or in any way use, the insert headset without a new clean and
non-defective ear-tip. Always make sure that the foam or ear-tip is mounted
correctly. Ear-tips and foam are for single use only.
The instrument is not intended for use in environments exposed to fluid
spills.
Check calibration if any parts of the equipment are exposed to shock or
rough handling.
Components marked for 'single use' are intended for a single patient during
a single procedure, and there is a risk of contamination if the component is
re-used. Components marked for 'single use' are not intended to be
reprocessed.
Use only transducers calibrated with the actual instrument.
In case of a serious incident with serious health impact for the patient or
user Interacoustics shall be informed. Beside that the competent authority in
patient's home country shall be informed. Interacoustics has a vigilance
system to help with this.
Storage outside temperature range as specified in Section 6 may cause
permanent damage to the instrument and its accessories.
Do not use the device in the presence of fluid that can come into contact
with any of the electronic components or wiring. Should the user suspect
fluids have contacted the system components or accessories, the unit
should not be used until deemed safe by an authorized service technician.
Do not place the instrument next to a heat source of any kind, and allow
sufficient space around the instrument to ensure proper ventilation.
Page 9