GE MAC 1600, Operator'S Manual

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1-10 MAC™ 1600 2028451-182B
Introduction
Biocompatibility
The parts of the product described in this operator’s manual, including
all accessories, that come in contact with the patient during the intended
use, fulfill the biocompatibility requirements of the applicable standards.
If you have questions in this matter, please contact GE or its
representatives.
Legal Notice
Our equipment contains several fields which can be filled in before
performing an ECG. While some of these fields are required, some are
optional and 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 is responsible for the effects of safety, reliability, and performance
only if:
„
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.
„
The equipment is used in accordance with the instructions for use.
General Information
Indications of Use
The MAC 1600 ECG Analysis System is a portable ECG acquisition,
analysis, and recording system. It is intended:
„
to acquire, analyze, display, and record information from adult and
pediatric populations,
„
to be used under the direct supervision of a licensed health care
practitioner,
„
to be used by trained operators in a hospital or medical professional’s
facility environment to record ECG signals from surface electrodes,
„
to offer two basic modes of operation: (1) resting ECG mode and
(2) arrhythmia mode
„
to print 6 or 12 leads of ECGs,