General Technical Specifications - Interacoustics AD629 Manual De Instrucciones

5 General technical specifications

AD629 technical specification
Medical CE-mark:
Standards:
Calibration
Air
Conduction
Bone
Conduction
Free Field
High
Frequency
Effective
masking
Transducers
Patient Response switch
Patient communication
Monitor
AD629 - Instructions for Use - EN
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
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 information and instructions is located in the AD629 Service
manual
DD45:
TDH39:
HDA300:
HDA280
DD65 v2
E.A.R Tone 3A/5A:
IP 30:
B71:
Placement: Mastoid
ISO 389-7 2005, ANSI S3.6-2010
ISO 389-5 2004, ANSI S3.6-2010
ISO 389-4 1994, ANSI S3.6-2010
DD45
TDH39
HDA300
HDA280
DD450
DD65 v2
B71 Bone
E.A.R Tone 3A/5A:
IP30
One hand held push button.
Talk Forward (TF) and Talk Back (TB).
Output through built-in speaker or through external earphone or speaker.
PTB/DTU report 2009
ISO 389-1 1998, ANSI S3.6-2010
PTB report PTB 1.61 – 4064893/13
PTB report 2004
PTB 1.61-4091606 2018
& AAU 2018
ISO 389-2 1994, ANSI S3.6-2010
ISO 389-2 1994, ANSI S3.6-2010 DES-2361
ISO 389-3 1994, ANSI S3.6-2010
Headband Static Force 4.5N ±0.5N
Headband Static Force 4.5N ±0.5N
Headband Static Force 4.5N ±0.5N
Headband Static Force 5N ±0.5N
Headband Static Force 10N ±0.5N
Headband Static Force 10N ±0.5N
Headband Static Force 5.4N ±0.5N
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