Sirona Dental Systems GmbH
Gebrauchsanweisung und Installation
3 System description
64 08 137 D3610
D3610.201.02.09.02 11.2017
29
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
3.13
Certification, registration and standards
The XIOS XG WiFi system complies with the following standards,
among others. It complies with the requirements of these regulations:
● CAN/CSA C22.2 No.601.1-M90 (Medical Electrical Equipment -
Part 1: General Requirements for Safety)
● ETSI-EN 301 489-3 (Electromagnetic Compatibility and Radio
Spectrum Matters (ERM); Electromagnetic Compatibility (EMC)
Standard for Radio Equipment and Services - Part 1: Common
Technical Requirements)
● IEC 60601-1 (Electro-Medical Devices - Part 1: General
Requirements for Safety)
● IEC 60601-1-2 (Medical electrical equipment - Part 1: General
requirements for safety; 2. Collateral standard: Electromagnetic
compatibility - Requirements and tests)
0413
This product bears the CE mark in accordance with the provisions of the
Council Directive 93/42/EEC of June 14, 1993 concerning medical
devices.
Original language of the present document: English
3.14
Symbols
Device with protection class II in accordance with IEC 60601-1
Type BF applied part according to IEC 60601-1
Please refer to manual first
0413
CE mark in accordance with Council Directive 93/42/EEC, stating the
manufacturer’s Notified Body.
This identification signifies fulfillment of the requirements of the national
standards of the USA and Canada.
Содержание XIOS XG Select
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