Biocompatibility; Legal Notice; Supplies And Accessories - GE MAC 2000 Service Manual

These devices are also possible sources of interference as they may emit higher
levels of electromagnetic radiation.
WARNING:
EQUIPMENT MALFUNCTION/INTERFERENCE — Use of portable phones or other
radio frequency (RF) emitting equipment near the system may cause unexpected
or adverse operation.
Do not use portable phones or other electronic equipment that may emit radio
frequency (RF) near this system.
WARNING:
EQUIPMENT MALFUNCTION/INTERFERENCE — Do not use the equipment or system
adjacent to, or stacked with, other equipment.
If adjacent or stacked use is necessary, test the equipment or system to verify
normal operation in the configuration in which you are using it.
WARNING:
ACCESSORIES/COMPONENTS — Adding accessories or components, or modifying
the medical device or system, may result in increased EMISSIONS or decreased
IMMUNITY of the device or system.
Use the following resources for more information on EMI/EMC and RF concerns:
• The Supplies and Accessories Reference Guide for your system
• Qualified GE Healthcare or approved third-party personnel
• The Electromagnetic Compatibility appendix in your system service or operator's
manual

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 filled in before performing
an ECG. Some of these fields are required, while 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 ensure that you comply with all applicable
legal requirements.

Supplies and Accessories

You should use only supplies and accessories that GE Healthcare recommends. For
a list of recommendations, refer to the supplies and accessories reference guide
for this system
Contact GE Healthcare before using anything that is not recommended for this system.
2053535-003C
MAC™ 2000 ECG Analysis System
Introduction
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