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GSI AudioStar Pro™ Clinical Audiometer
92
D-0100778 Rev C
Quality System
Manufactured, designed, developed and marketed under ISO 13485 certified quality systems
Compliance/Regulatory
Designed, tested and manufactured to meet the following domestic (USA), Canadian, European and
Standards
International Standards:
ANSI S3.6, IEC 60645-1, IEC 60645-2, ISO 389
UL 60601-1 American Standards for Medical Electrical Equipment
IEC/EN 60601-1 International Standards for Medical Electrical Equipment
CSA C22.2 # 601-1-M90
Medical Device Directive (MDD) to comply with EC Directive 93/42/EEC
Notes:
* Optional configuration
** The maximum HL values are applicable to the middle frequencies only
***RETSPL values interpolated