Warnings - Interacoustics affinity 2.0 Instructions For Use Manual

Affinity Instructions for Use - US
Optional special tests:
•
High Frequency audiometry
(HF440)
•
Multi Frequency module
(MF440)
•
Speech from hard-drive
(SFH440)
•
SISI test
•
Master Hearing Aid
(MHA440),
•
Hearing Loss Simulator
(HLS440)
•
Loudness Scaling (LS440)
•
QuickSIN
•
TEN test

1.5 Warnings

Throughout this manual the following meaning of warnings, cautions and notices are used:
1. The Affinity2.0 are class I medical products and they must only be connected to a power outlet with a
functional protective ground.
2. When connecting this device to a computer it is essential to insert a galvanic separation between the
device and the computer, unless the computer is battery operated or supplied by a medical approved
power supply.
3. If a mains powered computer is used without galvanic separation, it must be supplied from a medical
isolation transformer fulfilling the requirements of IEC/ES 60601-1.
4. Although the instrument fulfils the relevant EMC requirements precautions should be taken to avoid
unnecessary exposure to electromagnetic fields, e.g. from mobile phones etc. If the device is used
adjacent to other equipment it must be observed that no mutual disturbance appears, e.g. unwanted
noise in headphones. If disturbances are observed, try to separate the Affinity2.0 .0/Equinox2.0 from
the disturbing device.
5. If this apparatus is connected to one or more other devices with medical CE marking, to make up a
system or pack, the CE marking is only valid also for the combination if the supplier has issued a
declaration stating that the requirements in the Medical Device Directive article 12 are fulfilled for the
combination.
WARNING indicates a hazardous situation which, if not avoided, could result
in death or serious injury.
CAUTION, used with the safety alert symbol, indicates a hazardous situation
which, if not avoided, could result in minor or moderate injury.
NOTICE is used to address practices not related to personal injury.
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