Revision B1-6
Introduction: Safety Information
MAC 5000 resting ECG analysis system
2000657-002
Responsibility of the
Manufacturer
GE Marquette Medical Systems 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 Marquette.
■ 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
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 Marquette Medical Systems.
Contact GE Marquette Medical Systems 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 601 series safety standards, and/or the system
configuration must meet the requirements of the IEC 601-1-1 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 601-1
and/or IEC 601-1-1 harmonized national standard.