CardioSoft - Jaken Medical...

Introduction: Safety Information
GE Medical Systems Information Technologies is responsible for the
effects on safety, reliability, and performance of the product, only if:
assembly operations, extensions, readjustments, modifications,
or repairs are carried out by GE Medical Systems Information
Technologies or by persons authorized by GE Medical Systems
Information Technologies.
the electrical installation of the relevant room complies with the
requirements of the appropriate regulations, and
the product is used in accordance with the instructions given in
this manual.
The acquisition module is protected against the effects of cardiac
defibrillator discharge to ensure recovery as required by standards.
Accuracy of the Input Signal Reproduction
Overall System Error is tested using the method described in
AAMI EC11 3.2.7.1. The maximum overall system error is ± 5%.
Frequency Response is tested according to AAMI EC11 3.2.7.2,
methods A and D.
Modulating Effects in the Digital System
This device uses digital sampling techniques that may produce some
variation in amplitude of Q, R, and/or S waves. This effect may be
particularly noticeable in pediatric recordings. If this phenomenon is
observed, the clinician should be aware that the origin of amplitude
variations is not entirely physiologic. For measuring voltages of Q, R,
and S waves, it is advisable to use the QRS complexes with the
largest deflection of the particular waves.
Contact GE Medical Systems Information Technologies for
information before connecting any devices to this system that are not
recommended in this manual.
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 accessories not complying with the equivalent safety
requirements of this equipment may lead to a reduced level of safety
of the resulting system. Considerations 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.
Revision A CardioSoft 1-7
2023324-053