General Technical Specifications - Interacoustics Callisto Gebrauchsanweisung

Callisto™ Instructions for Use - EN

5. General technical specifications

Callisto™ general technical dpecifications
Medical CE-mark:
Standards:
Specifications Callisto™ Hardware:
PC requirements:
Supported Systems:
Available modules:
Database:
Computer
Communication:
Construction
:
Power:
Battery :
Battery working
voltage :
Operation
environment:
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 no. 0123.
IEC/ES 60601-1, 2005
Safety:
CAN/CSA-C22.2 No. 601.1-M90
IEC 60601-1 1988 .A1:1991, A2:1995
UL 60601-1:2003
Class I, Type B
IEC 60601-1-1 2000
EMC:
IEC 60601-1-2 :2007
Audiometer Tone: IEC 60645-1 2001/ANSI S3.6-2010 , Type 1 Tone audiometer
IEC 60645-4 1994/ANSI S3.6-2010 , High frequency audiometer
Audiometer Speech: IEC 60645-2 1997/ANSI S3.6-2010 Type A or A-E, STAF-1996,
Norway. Speech audiometer
Audiometer
AC: DD45 PTB/DTU report 2009
Calibration:
TDH39: ISO 389-1 1998, ANSI S3.6-2010
HDA200: ISO 389-5 2006, ANSI S3.6-2010
HDA300: PTB Report 1.61-4064893/13 2013
E.A.R Tone 3A/5A: ISO 389-2 1994, ANSI S3.6-2010
BC: B71: ISO 389-3 1994, ANSI S3.6-2010
FF:
HF:
Effective masking: ISO 389-4 1994, ANSI S3.6-2010
Hearing Aid
IEC 60118-0 1983, IEC60118-1 1998, IEC 60118-7 2005, ANSI
Analyzer: S3.22-2003.
Real ear
IEC61669 2001, ISO12124 2001, ANSI S3.46-1997
measurement:
2 GHz Intel Core 2 Duo CPU
2GB Ram
1.5 GB available disk space
1024x768 resolution (1280x1024 or higher recommended)
Hardware accelerated DirectX/Direct3D graphics card.
Windows® 7 SP1 (x86 and x64)
Windows 8 / 8.1 (x86 and x64)
Windows 10 (x86 and x64)
Callisto™ Suite AUD, REM, HIT.
OtoAccess and Noah-compatible office systems or later releases
USB interface, compatible with USB1.1 or later.
Plastic cabinet.
USB-powered with an internal "power boost" rechargeable battery
and load balancer.
Average: 300mA (Max: 500mA)
NP120 3.7V 1700 mAH battery lithium ion 53x35.2x11.
3.2 to 4.2V
ISO 389-7 2005, ANSI S3.6-2010
ISO 389-8 2004, ANSI S3.6-2010
Page 59