GE CASE V6.7, Operator'S Manual

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1-4 CASE Revision C
2060290-201
Safety Information
Safety Information
Intended Use

CASE is intended to be used by trained operators under direct
supervision of a licensed health care practitioner on adult and
pediatric patients.

CASE is designed to acquire, process, record, archive, analyze and
output ECG data (12 and 15 leads) during a period of physiologic
stress or during a resting ECG test and acquire data from ancillary
devices, such as spirometry and ambulatory blood pressure devices.
Furthermore, it provides median morphology recordings and records
ECG in real-time with and without arrhythmia detection.

The arrhythmia detection algorithm of CASE is provided to the user
for the convenience of automatic detection of arrhythmias but does
not provide alarms.

CASE provides the control of external devices. These are typically
treadmills and bicycle ergometers. Additionally, CASE
communicates with centralized electronic/digital storage systems via
data networks.
WARNING
Patient Hazard—Do not use the digital or analog outputs
to control therapeutic devices such as defibrillators.

CASE provides a user-selectable option for printouts of prognostic
scores on selected reports. Vector loops are also available.

CASE can be configured in a network environment for multiple
CASE and CardioSoft/CS stations allowing the user to create a
central database of patient demographics and collected patient
physiological data.

CASE is intended to be used primarily in the hospital. However, it
can also be used in clinics, physician offices, outreach centers or
wherever exercise stress testing, ECG, spirometry or ambulatory
blood pressure testing is performed.

CASE offers no diagnostic opinion to the user. Instead it provides
interpretive statements of morphology, rhythm, and conduction for
which the physician renders his/her own medical opinion.

CASE is not intended to be used as a transport device or for home
use.

CASE is not intended for use as a vital signs physiological monitor.

CASE is not intended for intracardiac use.

CASE is not intended for use as an emergency device.

CASE will not cause abnormal operation of a patient's cardiac
pacemaker or other electronic stimulators.

CASE is not intended for use with high frequency surgical units.
Disconnect the patient from CASE before using the high frequency
surgical unit.