Intended Use, Safety Information - GE eBike with Control Terminal PC Operator's Manual

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Figure 1-1 Controls and indicators eBike basic (top),
eBike comfort (bottom)
1 Control terminal
2 Connection for blood-pressure cuff, type B applied
part ( )
3 Adjusts angle of handlebar
4 Blood pressure cuff
5 Adjusts height of handlebar (eBike comfort only)
6 Castors
7 Speed readout for patient
8 Adjusts height of saddle (eBike basic only)
9 Indicates saddle height
10 Power switch
11 Connection panel
12 Leg levellers to ensure ergometer stability
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Intended Use, Safety Information

1 Intended Use, Safety Information
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1.1 Intended Use
The eBike with control terminal PC is a computer-
controlled, medical-grade bicycle ergometer. At pedal
speeds between 30 and 130 RPM and loads between 20
and 999 W, the ergometer operates independent of the
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pedal speed.
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The ergometer is only intended to be used as instructed in
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this manual for exercise tests as well as for rehabilitation
of cardiac and cardiovascular patients. If the ergometer is
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used for other purposes, the manufacturer cannot be held
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liable for personal injuries or property damage resulting
from unintended use of the equipment.
Two eBike models are available: eBike basic and eBike
comfort. What differentiates the eBike comfort from the
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eBike basic is the manual height adjustment for the
handlebar and the electric height adjustment for the
saddle. The patient may remain seated on the saddle
while it is raised or lowered.
The eBike with control terminal PC can be used both as a
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stand-alone device and in conjunction with GE Medical
Systems Information Technologies electrocardiographs
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(See "Connection to Electrocardiographs" on page 11).
When used in conjunction with an electrocardiograph,
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the electrocardiograph will control the bicycle ergometer.
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Furthermore, the electrocardiograph starts the
sphygmomanometer (option) integrated in the ergometer.
Additional blood-pressure measurements can be initiated
manually.
The display on the control terminal indicates the current
measuring values.
The connected electrocardiograph provides a full
documentation of the test.
The parts of the equipment described in this
manual, including all accessories, that come in
contact with the patient during the intended use,
fulfill the biocompatibility requirements of the
applicable standards if used as intended. If you
have questions in this matter, please contact GE
Medical Systems Information Technologies or its
Sales Representatives.
eBike with Control Terminal PC
Biocompatibility
2018112-001 Revision B