CardioSoft - Jaken Medical...

Introduction: Safety Information
Safety Information
Intended Use
CardioSoft is a PC-based system for electrocardiographic (resting
ECGs, exercise tests) and spirometric tests as well as for ambulatory
blood-pressure examinations. The program is intended for use under
the direct supervision of a health-care practitioner.
The PC with CardioSoft is not intended to be used as a vital signs
physiological monitor.
The PC with CardioSoft is not intended for use as an emergency
device.
The PC with CardioSoft will not cause abnormal operation of a
patient's cardiac pacemaker or other electronic stimulator.
The PC with CardioSoft is not intended for use with high frequency
surgical units. Disconnect the patient from the CardioSoft PC before
using the high frequency surgical unit.
CardioSoft uses an analysis program which can be used as a tool in
interpreting ECG waveforms.
The acquisition module is not intended for intracardiac use.
General Information
This manual is an integral part of the product. It should always be
kept near the PC. Close observance of the information given in the
manual is a prerequisite for proper product performance and correct
operation and ensures patient and operator safety. Please read the
manual once in its entirety, because information pertinent to several
chapters is given only once.
The GE Medical Systems Information Technologies quality
management system complies with the standards DIN EN ISO 9001
and EN ISO 13485.
To ensure maximum patient safety, interference-free operation and
the specified measuring accuracy, we recommend using only original
GE Medical Systems Information Technologies accessories. The user
is responsible for application of accessories from other
manufacturers.
The warranty does not cover damage resulting from the use of
unsuitable accessories and consumables from other manufacturers.
1-6 CardioSoft Revision A
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