General; Safety; Electromagnetic Compatibility - AGFA DR 10e User Manual

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 Directive
93/42/EEC on Medical Devices).

Safety

• IEC 60601-1

Electromagnetic Compatibility

• IEC 60601-1-2
• The product has been designed in accordance with 2014/53/EU Radio
Equipment Directive (RED)
Topics:
• Local regulations
• Restrictions on outdoor use
Local regulations
This product complies with local radio frequency regulations in the country or
region where you purchased the product. Note that it cannot be used in any
areas other than the country or region of its purchase.
The radio frequency channel (5 GHz) configured for indoor use may not be
usable in outdoor areas, depending on local radio frequency regulations.
If you would like to add other equipment to the environment where this
product is installed, or to use this product in other environments, please
consult your sales representative or local dealer for details.
Related Links
Remarks for HF-emission and immunity
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).
DR 10e, DR 14e, DR 17e | Introduction to the DR Detector | 33
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0370C EN 20200228 1449