ergoline ergoselect 400, Руководство оператора

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Clinical criteria
• excessive fatigue
• severe chest pain, dyspnea, or dizziness
• > 20 mmHg reduction in systolic blood pressure
• rise in blood pressure
I
ntended
u
se
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 Specifications).
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 injuries or
property damage resulting from the unintended use of the
equipment.
Note – Applied Parts
• Applied parts are components that are directly in contact
with the human body (e.g., blood pressure measuring devices).
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.
I
ntended
u
ser
Only the intended users are allowed to use the ergometer.
The group of intended users includes
• healthcare professionals thoroughly instructed on the
basis of the instructions for use
• patients of the intended patient group who have been
thoroughly instructed by trained specialists
The group of intended users does not include persons with
special needs, such as:
• impaired mental and physical abilities;
• impaired motor skills
which have an influence on the intended use of the medi‑
cal device.
I
ntended
P
atIent
G
rouP
The intended patient group includes all persons
• with a maximum weight of 140 kg.
• whose body height and age makes them eligible for
exercise testing. Due to various ergonomic aspects,
it is not possible to provide exact data for body height
and age.
• whose medical condition has been checked by a medical
specialist who judged them to be suitable for the appli‑
cation described in the intended use.
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, fulfill the biocompatibil‑
ity requirements of the applicable standards if applied as
intended.
If you have questions in this matter, please contact
ERGOLINE 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