Custo Med Bicycle Ergometer ec3000e, Operating Manual

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- 10 -
s
afety
i
nformation for
n
on
‑i
n
‑
vasive
b
looD
P
ressure
m
easure
‑
ment
Warning
• Patient Hazard •
Do not take blood pressure measurements with a cuff on
patients suffering from sickle cell anemia or where skin lesions
are likely to occur.
The cuff 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 fields are also capable of impairing the mea-
suring accuracy.
Note
• If the cuff pressure exceeds the maximum value of
300 mmHg during inflation, the inflation procedure will
be aborted and the cuff deflated.
As a redundant safety precaution, the cuff is immediately
deflated when the cuff pressure exceeds 320 mmHg.
You can check the proper functioning of this safety
precaution by abruptly bending your arm while the cuff
is being inflated, causing a brief overpressure in the cuff.
The cuff must deflate immediately.
• Measurements that did not yield a valid measurement will
not be repeated during the exercise test.
• If the inflation phase takes longer than 40 seconds or if
an adequate pressure does not build up in the cuff within
a reasonable period of time, the measurement will be
aborted and the cuff deflated.
• If a valid measurement cannot be completed within
120 seconds, the measurement will be aborted and the
cuff deflated.
• If the cuff pressure remains constant for some time, the
measurement will also be aborted and the cuff deflated.
i
ntenDeD
u
se
The ec3000e 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 Specifications).
The ec3000e ergometer may only be used in exercise test‑
ing as well as for rehabilitation of cardiac and cardiovas‑
cular 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 injuries or
property damage resulting from the unintended use of the
equipment.
b
ioComPatibility
The parts of the product described in this manual, includ‑
ing all accessories that come in contact with the patient
during the intended use, fulfill the biocompatibility
requirements of the applicable standards if applied as
intended.
If you have questions in this matter, please contact custo
med or a representative.
a
PPliCable
l
aws
, r
eGulations anD
D
ireCtives
•
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