Environmental Factors; Notice - Interacoustics Affinity Compact Instructions For Use Manual

2.3.6 Environmental factors

CAUTION

2.3.7 NOTICE

D-0123672-H – 2022/05
Affinity Compact - Instructions for Use - US
Interacoustics will make available on request circuit diagrams, component part
lists, descriptions, calibration instructions, or other inf ormation 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 f rom 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-def ective ear-tip. Always make sure that the f oam or ear-tip is mounted
correctly. Ear-tips and f oam are f or single use only.
The instrument is not intended f or use in environments exposed to f luid spills.
Check calibration if any parts of the equipment are exposed to shock or rough
handling.
Components marked f or 'single use' are intended f or a single patient during a
single procedure, and there is a risk of contamination if the component is re-
used. Components marked f or '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 f or the patient or user
Interacoustics shall be inf ormed. Beside that the competent authority in
patient's home country shall be inf ormed. Interacoustics has a vigilance
system to help with this.
Storage outside temperature range as specif ied in Section 2.1 may cause
permanent damage to the instrument and its accessories.
Do not use the device in the presence of f luid that can meet any of the
electronic components or wiring. Should the user suspect f luids have contacted
the system components or accessories, the unit should not be used until
deemed saf e by an authorized service technician.
Do not place the instrument next to a heat source of any kind and allow
suf f icient space around the instrument to ensure proper ventilation.
To prevent system f aults, take appropriate precautions to avoid PC viruses and
similar.
Using operating systems where Microsof t have discontinued sof tware and
security support will increase the risk f or viruses and malware, which may result
in breakdowns, data loss and data thef t and misuse.
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