1-6 MAC™ 3500 Resting ECG Analysis System Revision L
2021337-036
Introduction: Safety Messages
General
The intended use of this device is to record ECG signals from surface ECG
electrodes. This device can analyze, record, and store electrocardiographic
information from adult and pediatric populations. This data can then be computer
analyzed with various algorithms such as interpretive ECG and signal averaging for
presentation to the user.
This device is intended for use under the direct supervision of
a licensed health care
practitioner.
Failure on the part of the responsible individual, hospital, or institution using this
equipment to implement
a satisfactory maintenance schedule may cause undue
equipment failure and possible health hazards.
To ensure patient safety, use only parts and accessories manufactured
or
recommended by GE Healthcare.
Contact GE Healthcare for i
nformation before connecting any devices to this
equipment that are not recommended in this manual.
If the installation of this equipment, in t
he USA, will use 240 V rather than 120 V,
the source must be a center-tapped, 240 V, single-phase circuit.
Parts and accessories used must meet the requireme
nts of the applicable IEC 60601
series safety standards, and/or the system configuration must meet the requirements
of the IEC 60601-1-1 medical electrical systems standard.
The use of ACCESSORY equipment not complying with the equivalent safety
requirements of this equipment may
lead to a reduced level of safety of the resulting
system. Consideration relating to the choice shall include:
use of the accessory in the PATIENT VICINITY; and
evidence that the safety certification of the ACCESSORY has been
performed
in accordance to the appropriate IEC 60601-1
and/or IEC
60
601-1-1 harmonized national standard.
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