GSi TYMPSTAR PRO - Appendix B: Technical Data; Standards Compliance and Environmental Specs

GSI TympStar Pro User Manual
D-0129427 Rev. B Page 141 of 162
APPENDIX B – TECHNICAL DATA
The TympStar Pro is an active, diagnostic medical product. The device is classified as a
class IIa device according to the EU medical directive 93/42/EEC and a class II device
according to the US FDA.
Standards Compliance
Safety and Electromagnetic
compatibility (EMC)
IEC 60601-1: 2012
IEC 60601-1-2: 2015
Calibration and Test Signal
ISO 389-2: 1994
ISO 389-4: 1994
Immittance
IEC 60645-5: 2004, Type 1
ANSI S3.39 (1987+R2002)
Protection from Fluids
IPX0 – Ordinary equipment
General Specifications
ENVIRONMENTAL
Transport and
Handling
Transport package shall be kept away from rain
and in dry conditions
Temperature
Operation: + 15° C to + 35° C (+ 59° F to + 95° F)
Transport: - 20° C to + 50° C (- 4° F to + 122° F)
Storage: 0° C to + 50° C (+32° F to + 122° F)
Humidity
Operation: Maximum relative humidity 90 %,
non-condensing, at 40° C
Transport and Storage: Maximum relative
humidity 93 %, non-condensing
Ambient air pressure
98 kPa – 104 kPa
Altitude
Maximum altitude: 4000 m (13,123 feet) above
sea level
Location
Indoor use, quiet environment
Mode of Operation
Continuous
Degree of Mobility
Portable equipment