KLS Martin CEMOR, Mounting Instructions

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Mounting Instructions
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CEMOR Monitor Suspension System
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3.4 Notes for Operators
• The device is manufactured according to the current state of technology and is safe to
operate. Potential dangers may still be present, however, when using this device. This
applies in particular if the device is operated by personnel without the necessary
qualifications, or if it is used improperly and not in accordance with its intended purpose.
•
The device may be operated, cleaned, and disinfected solely by qualified medical staff.
•
All the assembly, disassembly and adjustment work described in these mounting
instructions may be performed only by qualified staff assigned and instructed by the
operator.
•
For reasons of safety, any actions or interventions extending beyond this scope may be
carried out only by Gebrüder Martin or by a company authorized by Gebrüder Martin.
Authorization of a company requires successful participation of the company’s service
technicians in a technical training course conducted by Gebrüder Martin. The authorization
is granted for a limited time period.
3.5 Standards and Guidelines
The device meets the safety requirements of the following standards, regulations and
guidelines:
Abbreviation Designation
MPG German Medical Devices Act (Medizinproduktegesetz)
93/42/EWG German Medical Devices Directive (Medizinprodukterichtlinie)
IEC 60601-1
Electrical medical devices, Part 1: General specifications for safety, including the
essential performance features
DIN EN 62353
Medical electrical equipment – Recurrent test and test after repair of medical
electrical equipment
3.6 Combination with Products by Other Manufacturers
It is the responsibility of the operator to validate the complete system and, if applicable,
complete a conformity evaluation procedure and submit a declaration in accordance with
Article 12 of 93/42/EWG.
Please refer to the instruction manuals of the respective manufacturer for the information
required to operate the end device.
Power supply units provided for supplying end devices must ensure galvanic separation and be
equipped with two protective measures in accordance with IEC 60601-1.