Compatibility; Compliance - AGFA DX-G User Manual

Compatibility

The digitizer must only be used in combination with other equipment or
components if these are expressly recognized by Agfa as compatible. A list of
such equipment and components is available from Agfa service on request.
Changes or additions to the equipment must only be carried out by persons
authorized to do so by Agfa. Such changes must comply with best engineering
practices and all applicable laws and regulations that have the force of law
within the jurisdiction of the hospital.
Accessory equipment connected to any interfaces must be certified according
to the respective IEC standards (e.g. IEC 60950 for data processing equipment
or IEC 60601-1 for medical equipment). Furthermore all configurations shall
comply with the requirements for ME systems according to IEC 60601-1.
Everybody who connects additional equipment to the signal input part or
signal output part configures a medical system, and is therefore responsible
that the system complies with the requirements for ME systems according to
IEC 60601-1. If in doubt, consult your local service organization.

Compliance

The digitizer 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 MDD
(European Council Directive 93/42/EEC on Medical Devices).
The digitizer has been designed in accordance with the IEC 60601-1, Ed. 2
and 3: Medical electrical equipment - Part 1: General requirements for basic
safety and essential performance.
Refer to Appendix B for an overview of applied standards.
2321 E EN 20130722
Caution: The digitizer must not be connected to any version of the Agfa
TM
ADC QS or ADC VIPS
TM
Software.
DX-G/DX-M
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