1-6 MAC™ 5000 resting ECG analysis system Revision B
2024917-010
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 Medical Systems Information Technologies.
Contact GE Medical Systems Information Technologies for information
before connecting any devices to this equipment that are not
recommended in this manual.
If the installation of this equipment, in the 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 requirements 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 60601-1-1 harmonized national standard.
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