D-0123672-H – 2022/05
Affinity Compact - Instructions for Use - US
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9
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.
2.3.6 Environmental factors
Storage outside temperature range as specified in Section 2.1 may cause
permanent damage to the instrument and its accessories.
Do not use the device in the presence of fluid that can meet 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.
2.3.7 NOTICE
To prevent system faults, take appropriate precautions to avoid PC viruses and
similar.
Using operating systems where Microsoft have discontinued software and
security support will increase the risk for viruses and malware, which may result
in breakdowns, data loss and data theft and misuse.
CAUTION
