64 09 713 D3610
D3610
.
201.01.08
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02 09.2016
23
Sirona Dental Systems GmbH
3 System description
Operating Instructions and Installation XIOS XG USB module and sensors
3.10 Certification, registration and standards
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Operating and transport conditions
3.10
Certification, registration and standards
Certification
The XIOS XG USB system complies with the following standards, among
others. It complies with the requirements of these regulations:
EMC / safety
● IEC 60601-1 (Standard for Safety Medical Electrical Equipment -
Part 1: General Requirements for Safety)
● IEC 60601-1-1 (Medical electrical equipment - Part 1-1: General
requirements for safety; 1. Collateral standard: Safety requirements
for medical electrical systems)
● IEC 60601-1-2 (Medical electrical equipment - Part 1: General
requirements for safety; 2. Collateral standard: Electromagnetic
compatibility - Requirements and tests)
Quality
● AAMI TIR12:2004 (Designing, testing and labeling reusable medical
devices for reprocessing in health care facilities: A guide for device
manufacturers)
● CAN/CSA C22.2 No.601.1-M90 (Medical Electrical Equipment -
Part 1: General Requirements for Safety)
Active sensor area:
Size 0 - sensor = 18 x 24 mm
Size 1 - sensor = 20 x 30 mm
Size 2 - sensor = 25.6 x 36 mm
External dimensions:
Size 0 - sensor = 23.6 x 32 x 7.5 mm
Size 1 - sensor = 25.4 x 38.3 x 7.5 mm
Size 2 - sensor = 31.2 x 43 x 7.5 mm
Cable length:
max. 2.70 m
Mode of operation:
Continuous operation
Additional information:
The unit must not be used near flammable
anesthesia gas mixtures containing air,
oxygen or nitrogen oxide.
Transport and storage
conditions:
Temperature: -40 °C (-40 °F) to 70 °C (158
°F)
Relative humidity: 20 % to 85 %
Air pressure: 500 to 1060 hPa
Operating conditions:
Temperature: 10 °C (50 °F) to 40 °C (104 °F)
Relative humidity: 20 % to 85 %
Air pressure: 700 to 1060 hPa
Operating altitude:
≤ 2000 m