General
• The product has been designed in accordance with the MEDDEV
Guidelines relating to the application of Medical Devices and have been
tested as part of the conformity assessment procedures required by
93/42/EEC Medical Device Directive (European Council
Directive93/42/EEC on Medical Devices).
• IEC 62366
Safety
• IEC 60601-1
• IEC 60601-1-6
X-Ray Safety
• IEC 60601-2-54
• IEC 60601‐1‐3
Electromagnetic Compatibility
• IEC 60601-1-2
Restrictions on outdoor use
There are restrictions on the outdoor use of the U-NII Low (5150-5250 MHz)
and U-NII Mid (5250-5350 MHz) bandwidths of the WLAN module
incorporated in the device in the following Member States: Belgium (BE),
Bulgaria (BG), Czech Republic (CZ), Denmark (DK), Germany (DE), Estonia
(EE), Ireland (IE), Greece (EL), Spain (ES), France (FR), Croatia (HR), Italy
(IT), Cyprus (CY), Latvia (LV), Lithuania (LT), Luxembourg (LU), Hungary
(HU), Malta (MT), Netherlands (NL), Austria (AT), Poland (PL), Portugal
(PT), Romania (RO), Slovenia (SI), Slovakia (SK), Finland (FI), Sweden (SE)
and United Kingdom (UK).
Earthquake resistance
Earthquake resistance is available on system configurations containing the
earthquake kit.
• CBSC Title 24, Part 2 (OSHPD)
After an earthquake, preventive maintenance is recommended.
After an earthquake, the lifetime of the system may be reduced and there is no
warranty for the complete lifetime anymore.
DR 800 | Product Information | 277
0392C EN 20210309 1049
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