Publicité
Les langues disponibles
Les langues disponibles
A
A – T
PPENDIX
ECHNICAL
The AudioStar Pro is an active, diagnostic medical product. The device is classified as a
class Iia device according to the Medical Device Regulation (EU) 2017/745 and a class II
device according to the US FDA. Manufactured, designed, developed, and marketed under
ISO 13485 certified quality systems.
Standards Compliance
Safety and Electromagnetic
compatibility (EMC)
Calibration and Test Signal
General Specifications
Transport and
Handling
Temperature
Humidity
Ambient air pressure
Location
Expected Service Life
D-0131088 Rev C, 2022-07
GSI AudioStar Pro Instructions for Use
D
ATA
IEC 60601-1,
IEC 60601-1-2
ANSI S3.6 (2018) Type 1
IEC 60645-1 (2017) Type 1
IEC 60645-2 (2017)
ISO 389-2
ISO 389-3
ISO 389-4
ISO 389-5
ISO 389-7
ISO 389-8
ENVIRONMENTAL
Transport package shall be kept away from rain
and in dry conditions
Operation: + 15° C to + 40° C (+ 59° F to + 104° F)
Transport: - 20° C to + 50° C (- 4° F to + 122° F)
Storage: 0° C to + 50° C (+32° F to + 122° F)
Operation: Maximum relative humidity 95 %,
non-condensing
Transport and Storage: Maximum relative
humidity 93 %, non-condensing
98 kPa – 104 kPa
Indoor Use
7 years
Page 44 of 84
Publicité
