DD+DIS238.06E
Generic Safety Directions
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Edition 1, Revision 3 Generic Safety Directions for HealthCare Imaging Products Page 14 of 28
11 Accessories and Spare Parts
Parts and accessories replacement:
WARNING:
Hazards may be introduced because of component failure or improper operation.
INSTRUCTION:
• Replace defective parts with Agfa HealthCare original spare parts.
• Use only tools and measuring instruments which are suitable for the procedure.
• Only approved Agfa HealthCare accessories must be used. For a list of compatible
accessories contact your local Agfa HealthCare organization or www.agfa.com.
12 Compliance
Directive for HealthCare Imaging Products:
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
(OJ No L 169/1 of 1993-07-12)
• ANNEX I - ESSENTIAL REQUIREMENTS - GENERAL REQUIREMENTS The
products are designed and manufactured in such a way that, when used under the
conditions and for the purposes intended and, where applicable, by virtue of the
technical knowledge, experience, education or training of intended users, they will not
compromise the clinical condition or the safety of patients, or the safety and health of
users.
• ANNEX II - EC DECLARATION OF CONFORMITY: Full quality assurance system
ISO 13485
• ANNEX X - CLINICAL EVALUATION: The clinical evaluation follows a defined and
methodologically sound procedure.
07-2009 Agfa Company Confidential
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