8
ergoselect 1
2 Safety Information
Clinical criteria
• excessive fatigue
• severe chest pain, dyspnoea, or dizziness
• > 20 mmHg reduction in systolic blood pressure
• rise in blood pressure
2.2 Intended Use
The medical device is a stationary ergometer used for
reproducible, controlled stress testing of the cardiovascular
system.
It is employed as a training device in the field of ortho‑
pedics, in rehabilitation and secondary prevention for the
treatment of decreased physical fitness resulting from the
following conditions:
• cardiovascular diseases
• metabolic disorders
• cancers
• pulmonary diseases
• sedentary lifestyle
Furthermore, it is a diagnostic tool in performing exercise
stress tests.
2.3 Intended User
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 operator manual
• patients of the intended patient group who have been
thoroughly instructed by trained specialists
The group of intended users does not include persons
whose mental and physical capabilities and skills have an
adverse effect on their ability to use the medical device in
accordance with its intended purpose.
2.4 Intended Patient Group
The intended patient group includes all persons
• with a maximum weight of 160 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.
2.5 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, fulfill the biocompatibility require‑
ments of the applicable standards if applied as intended.
If you have questions in this matter, please contact
ergoline GmbH or an ergoline representative.
2.6 Applicable Laws, Regulations
and Directives
If you have questions regarding laws, regulations or direc‑
tives related to the product, please contact ergoline GmbH.
