MAC 5000 Resting ECG Analysis System ... - Jaken Medical...

Introduction: Safety Information
Legal Notice
Our equipment contains several fields which can be filled in
before performing an ECG. Some of these fields must be
filled in before performing an exam, some are optional and
therefore left to the user to assess whether they are needed
to perform the exam. A field RACE is one of these optional
fields. It has been acknowledged by the medical profession
as useful to analyze some pathologies. You should be aware
that, in some jurisdictions, the processing of data revealing
an individual’s racial origin is subject to legal
requirements, such as obtaining the patient’s prior consent.
If you elect to collect this type of data, it is your
responsibility to ensure that you comply with all applicable
legal requirements.
Responsibility of the Manufacturer
GE Medical Systems Information Technologies is
responsible for the effects of safety, reliability, and
performance only if:
n Assembly operations, extensions, readjustments,
modifications, or repairs are carried out by persons
authorized by GE Medical Systems Information
Technologies.
n The electrical installation of the relevant room
complies with the requirements of the appropriate
regulations.
n The equipment is used in accordance with the
instructions for use.
MAC 5000 System — 2000657-033, Revision A 1-7