ergoline ergoselect 100 User Manual

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safety information for
non‑invasive BlooD Pressure
measurement
Warning
• Patient Hazard •
Do not take blood pressure measurements with a cu on
patients suering from sickle cell anemia or where skin lesions
are likely to occur.
The cu may cause hematomas in patients with severe blood
coagulation disease. In these instances, the user must take
a decision for or against automatic blood pressure measure-
ments.
Caution
• Compromised Measuring Accuracy •
Arrhythmias occurring frequently during a measurement may
compromise the accuracy of the measurement.
In certain cases, a valid measurement will not be possible.
Electromagnetic elds are also capable of impairing the mea-
suring accuracy.
Note
• The blood pressure module and the approved accessories
are debrillation-proof and may remain attached to the
patient during debrillation.
• If the cu pressure exceeds the maximum value of
300 mmHg during ination, the ination procedure will be
aborted and the cu deated.
As a redundant safety precaution, the cu is immediately
deated when the cu pressure exceeds 320 mmHg.
You can check the proper functioning of this safety precau-
tion by abruptly bending your arm while the cu is being
inated, causing a brief overpressure in the cu. The cu
must deate immediately.
• Measurements that did not yield a valid measurement will
not be repeated during the exercise test.
• If the ination phase takes longer than 40 seconds or if an
adequate pressure does not build up in the cu within a
reasonable period of time, the measurement will be aborted
and the cu deated.
• If a valid measurement cannot be completed within
120 seconds, the measurement will be aborted and the cu
deated.
• If the cu pressure remains constant for some time, the
measurement will also be aborted and the cu deated.
intenDeD use
The ergoselect is a computer‑controlled medical ergometer.
At pedal speeds between 30 and 130 RPM and loads
between 6 and 999 watt, the ergometer operates indepen‑
dent of the pedal speed.
The speed‑independent range is shown in the Appendix
(Technical Specications).
The ergoselect ergometer may only be used in exercise
testing as well as for rehabilitation of cardiac and cardio‑
vascular patients according to the instructions given in
this manual. If the ergometer is used for other purposes,
the manufacturer cannot be held liable for personal inju‑
ries or property damage resulting from the unintended use
of the equipment.
BioComPatiBility
The parts of the product described in this manual, includ‑
ing all accessories that come in contact with the patient
during the intended use, fulll the biocompatibility
requirements of the applicable standards if applied as
intended.
If you have questions in this matter, please contact
ERGOLINE or a representative.
aPPliCaBle laws, reGulations anD
DireCtives
• 93/42/EEC (Medical Device Directive of the EU)
• 89/336/EEC (Electromagnetic Compatibility Directive
of the EU)
• EN 1060‑1 Non‑invasive sphygmomanometers, Part 1:
General requirements
• EN 1060‑3 Non‑invasive sphygmomanometers, Part 3:
Supplementary requirements for electro‑mechanical
blood pressure measuring systems

ergoline ergoselect 100 Specifications

General

Brand	ergoline
Model	ergoselect 100
Category	Exercise Bike
Language	English