9
Ergometer custo ec5000 | EXT 0001 – DK 1585 | Version 001 – 2015-11-13
S
AFETY
I
NFORMATION
FOR
N
ON
-I
NVASIVE
B
LOOD
P
RESSURE
M
EASUREMENT
Warning
• Patient Hazard •
Do not take blood pressure measurements with a cuff on pa-
tients suff ering from sickle cell anemia or if 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 measurements.
Caution
• Compromised Measuring Accuracy •
Arrhythmias occurring frequently during a measurement may
compromise the accuracy of the measurement.
Valid measurements may not be possible under certain circum-
stances.
Electromagnetic fi elds are also capable of impairing the measur-
ing accuracy.
Note
•
If the cuff pressure exceeds the maximum value of
300 mmHg during infl ation, the infl ation procedure will
be aborted and the cuff defl ated. As a redundant safety
precaution, the cuff is immediately defl ated when the cuff
pressure exceeds 320 mmHg.
You can check the proper functioning of this safety precau-
tion by abruptly bending your arm while the cuff is being
infl ated, causing a brief overpressure in the cuff . The cuff
must defl ate immediately.
•
Measurements that did not yield a valid measurement will
not be repeated during the exercise test.
•
If the infl ation 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 defl ated.
•
If a valid measurement cannot be completed within
120 seconds, the measurement will be aborted and the cuff
defl ated.
•
If the cuff pressure remains constant for some time, the
measurement will also be aborted and the cuff defl ated.
I
NTENDED
U
SE
The ec5000 is a computer-controlled medical ergometer,
which operates at pedal speeds between 30 and 130 RPM
and loads between 6 and 999 W.
The speed-independent range is shown in the Appendix
(Specifi cations).
The ec5000 ergometer may only be used in exercise testing
as well as for rehabilitation of cardiac and cardiovascular
patients according to the instructions given in this manual.
If the ergometer is used for other purposes, the manufac-
turer cannot be held liable for personal injuries or property
damage resulting from the unintended use of the equip-
ment.
Note - Applied Parts
•
Applied parts are components that are directly in contact with
the human body (e.g., blood pressure measuring devices).
B
IOCOMPATIBILITY
The parts of the product described in this manual,
including all accessories that come in contact with the
patient during the intended use, fulfi ll the biocompatibil-
ity requirements of the applicable standards if applied as
intended.
If you have questions in this matter, please contact
custo med or one of their representatives.
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
Note - Stability
•
Ensure the stability of the ergometer. If the maximum per-
mitted patient weight is exceeded by 10%, the stability of
the ergometer can no longer be guaranteed. It may become
unstable as a result.
Summary of Contents for Ergometer custo ec5000
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