Interacoustics AD629 - Technical Specifications and Compliance; AD629 Technical Specifications

D-0133833-A – 2022/09
AD629 - Instructions for Use - EN Page 44
5 General technical specifications
5.1 AD629 technical specification
Medical CE-mark:
The CE-mark indicates that Interacoustics A/S meets the requirements of
Annex II of the Medical Device Directive 93/42/EEC.
Approval of the quality system is made by TÜV – identification no0123
Standards:
Safety:
IEC 60601-1 2005/EN 60601-1 2006 and A1 2012
ANSI/AAMI ES60601-1:2005/(R)2012
CAN/CSA-C22.2 No. 60601-1:14
Class II, Type B applied parts
EMC:
IEC 60601-1-2 (2014)
Audiometer:
Tone Audiometer: IEC 60645 -1 (2017), ANSI S3.6 (2010),
Type 2
Speech Audiometer: IEC 60645-1 (2017)/ANSI S3.6 (2010)
type B or B-E.
Auto threshold tests: ISO 8253-1 (2010)
Calibration
Calibration information and instructions is located in the AD629 Service
manual
Air
Conduction
DD45: PTB/DTU report 2009
TDH39: ISO 389-1 1998, ANSI S3.6-2010
HDA300: PTB report PTB 1.61 – 4064893/13
HDA280 PTB report 2004
DD65 v2
PTB 1.61-4091606 2018
& AAU 2018
E.A.R Tone 3A/5A: ISO 389-2 1994, ANSI S3.6-2010
IP 30: ISO 389-2 1994, ANSI S3.6-2010 DES-2361
Bone
Conduction
B71: ISO 389-3 1994, ANSI S3.6-2010
Placement: Mastoid
Free Field
ISO 389-7 2005, ANSI S3.6-2010
High
Frequency
ISO 389-5 2004, ANSI S3.6-2010
Effective
masking
ISO 389-4 1994, ANSI S3.6-2010
Transducers
DD45 Headband Static Force 4.5N ±0.5N
TDH39 Headband Static Force 4.5N ±0.5N
HDA300 Headband Static Force 4.5N ±0.5N
HDA280 Headband Static Force 5N ±0.5N
DD450 Headband Static Force 10N ±0.5N
DD65 v2 Headband Static Force 10N ±0.5N
B71 Bone Headband Static Force 5.4N ±0.5N
E.A.R Tone 3A/5A:
IP30
Patient Response switch
One hand held push button.
Patient communication
Talk Forward (TF) and Talk Back (TB).
Monitor
Output through built-in speaker or through external earphone or speaker.