Product Description; Warnings; Complaints/Safety Reporting - Interacoustics AD629 Instructions For Use Manual

1.3 Product description

The AD629 is a 2 channel clinical audiometer offering air, bone, speech and free field line output. It
offers a wide range of clinical test features such as high frequency, SISI, etc.
Included parts
Optional parts

1.4 Warnings

Throughout this manual, the following meaning of warnings, cautions and notices are used:
NOTICE

1.5 Complaints/safety reporting:

Please contact your local distributor in case of any incident related to product defects (hardware
defects or software bugs) or adverse events (which does not necessarily have a causal
association to the product). It is recommended for a user to report all the known facts about the
incident. Upon receipt of any serious incident with serious health impact for the patient or user
(serious adverse events), local distributor shall report to Interacoustics through its appropriate
vigilance system. Interacoustics shall ensure that the regulatory authority in patient's home country is
informed according to the vigilance requirements. Interacoustics shall handle all the product complaints and
adverse events as per the internal procedure.
1)
Applied parts according to IEC60601-1
D-0133833-A – 2022/09
AD629 - Instructions for Use - EN
DD45 Audiometric headset
B71 Bone conductor
APS3 Patient response button
Goose neck microphone
Power cable
Operation manual CD
Multilingual Instructions for Use
Diagnostic Suite software
OtoAccess® database
21925 Amplivox audio cups, noise reducing headset
Carrying case (Standard or Trolly Style)
EARTone3A/5A Audiometric insert phones
IP30 Audiometric insert phones
HDA300 Audiometric headset with double mono 6.3mm jack
TDH39 Audiometric headset
DD450 Audiometric headset
DD65v2 Audiometric headset
B81 Bone conductor
Talk back microphone
Sound field speakers SP90 (with external power amp)
AP12 Power Amplifier 2x12 Watt
AP70 Power Amplifier 2x70 Watt
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 damage of the equipment.
NOTICE is used to address practices not related to personal injury or
damage of the equipment.
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