CE-2 ApexPro™ 2001989-200E
CE marking information
assembly operations, extensions, readjustments, modifications, or repairs are
carried out by persons authorized by GE;
the electrical installation of the relevant room complies with the
requirements of the appropriate regulations; and,
the device is used in accordance with the instructions for use.
All publications conform with the product specifications and applicable IEC
publications on safety and essential performance of electromedical equipment as
well as with applicable UL and CSA requirements and AHA recommendations
valid at the time of printing.
The quality management system complies with the international standards ISO
9001 and ISO 13485, and the Council Directive on Medical Devices 93/42/EEC
Annex II.
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