General Information; Intended Use - GE MAC 5000 Operator's Manual

Responsibility of the Manufacturer
GE Medical Systems Information Technologies is
responsible for the effects of safety, reliability, and
performance only if:
n
Assembly operations, extensions, readjustments,
modifications, or repairs are carried out by persons
authorized by GE Medical Systems Information
Technologies.
n
The electrical installation of the relevant room
complies with the requirements of the appropriate
regulations.
n
The equipment is used in accordance with the
instructions for use.
MAC 5000 System — 2000657-024, Revision A

General Information

Intended Use

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.
This device is not intended for use with high frequency
surgical units. Disconnect the patient from the device
before using the high frequency surgical unit.
This equipment uses a computerized ECG analysis
program which can be used as a tool in ECG tracing
interpretation.
Introduction: Safety Information
1-9