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Certificate of conformity and system validation – Metrohm 754 Dialysis Unit User Manual

Page 45

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5 Appendix

754 Dialysis Unit

42

5.4.3 Certificate of conformity and system validation

Certificate of Conformity and System Validation

This is to certify the conformity to the standard specifications for electrical appli-
ances and accessories, as well as to the standard specifications for security and
to system validation issued by the manufacturing company.

Name of commodity:

754 Dialysis Unit

Name of manufacturer:

Metrohm Ltd., Herisau, Switzerland

Principal technical information:

Voltages:

100…120, 220…240 V

Frequency:

50

60 Hz

This Metrohm instrument has been built and has undergone final type testing
according to the standards:

IEC801-2/IEC1000-4-2 (class 4), IEC801-3/IEC1000-4-3 (class 3),
IEC801-4/IEC1000-4-4 (class 4), IEC801-6/IEC1000-4-6 (class 3),
IEC1000-4-11, EN55011 (class B), EN55022 (class B), EN50081-1,
EN50082-2, EN60555-2

Electromagnetic compatibility

IEC1010, EN61010, UL3101-1

Security specifications

The technical specifications are documented in the instruction manual.

Metrohm Ltd. is holder of the SQS-certificate of the quality system ISO 9001 for
quality assurance in design/development, production, installation and servicing.

Herisau, September 27, 1997

Dr. J. Frank

Ch. Buchmann

Development Manager

Production and
Quality Assurance Manager