D-0133833-A – 2022/09
AD629 - Instructions for Use - EN
Page 2
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.
1.4 Warnings
Throughout this manual, the following meaning of warnings, cautions and notices are used:
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
Included parts
DD45 Audiometric headset
1
B71 Bone conductor
1
APS3 Patient response button
1
Goose neck microphone
Power cable
Operation manual CD
Multilingual Instructions for Use
Optional parts
Diagnostic Suite software
OtoAccess® database
21925 Amplivox audio cups, noise reducing headset
1
Carrying case (Standard or Trolly Style)
EARTone3A/5A Audiometric insert phones
1
IP30 Audiometric insert phones
1
HDA300 Audiometric headset with double mono 6.3mm jack
TDH39 Audiometric headset
1
DD450 Audiometric headset
1
DD65v2 Audiometric headset
1
B81 Bone conductor
1
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
NOTICE
is used to address practices not related to personal injury or
damage of the equipment.