GE CASE V6.7, Operator'S Manual

Page: 19 / 342

Revision C CASE 1-5
2060290-201
Safety Information
General Information

This manual is an integral part of the device. It should always be
kept near the device. Close observance of the information given in
the manual is a prerequisite for proper device 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.

To ensure maximum patient safety, interference-free operation and
the specified measuring accuracy, we recommend using only original
GE Healthcare 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.

GE Healthcare is responsible for the effects on safety, reliability, and
performance of the device, only if:

assembly operations, extensions, readjustments, modifications,
or repairs are carried out by GE Healthcare or by persons
authorized by GE Healthcare.

the electrical installation of the relevant room complies with the
requirements of the appropriate regulations, and

the device is used in accordance with the instructions given in
this manual.

This equipment is protected against the effects of cardiac
defibrillator discharge to ensure recovery as required by test
standards.

Accuracy of the Input Signal Reproduction

Recording speed accuracy is tested using the method described in
IEC 60601-2-51 sub-clause 51.108.4.4. The maximum error is +/-
5 %.

Frequency Response is tested according to IEC 60601-2-51 sub-
clause 51.107.1 conforming to the specifications of sub-clause
51.107.1.1.

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 Healthcare 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