Biocompatibility; Legal Notice - GE MAC 5 A4 Operator's Manual

Essential Performance
Defibrillation Protection
ECG Measurements *
FILTERS (Including Line
Frequency Disturbance FILTERS)
* Essential performance is amplitude measurement accuracy as defined by IEC 60601-2-25 Section
202.6.2. The difference for each amplitude measurement shall not deviate from the reference value
by more than ± 50 μV for reference values ≤ 500 μV, or by more than 5 % or ±100 μV (whichever is
greater) for reference values > 500 μV.

Biocompatibility

The parts of the system described in this manual that come into contact with the
patient during the intended use, including all accessories, fulfill the biocompatibility
requirements of the applicable standards. If you have questions in this matter contact
your GE Healthcare representative.

Legal Notice

GE Healthcare software contains several fields that can be populated before
performing an ECG. Some of these fields are required, others are optional and
left to the user to assess whether they are needed to perform the exam. The field
Race is one of these optional fields. Race 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 make sure that you comply with all
applicable legal requirements.
5864335-001-1
Degradation Caused by
Electromagnetic Disturbances
No degradation.
Temporary function loss during
Electrostatic Discharge (ESD)
and Electrical Fast Transient/
Burst (EFT) disturbances.
No degradation.
MAC ™ 5 A4/MAC ™ 5 A5/MAC
Regulatory and Safety Information
Essential Performance
Maintainance
Not applicable.
The device resumes normal
operation within 10 seconds
after the disturbance is
removed:
• No operator setting or
stored data loss;
• Will continue to perform its
intended functions;
• Will maintain the essential
performance.
Not applicable.
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