6
ergoselect 1
ergoselect 1
7
2 Safety Information
Caution
Additional equipment connected to medical electrical
equipment must comply with the respective IEC or
ISO standards (e.g., IEC 60950 for data processing
equipment).
Furthermore, all configurations must meet the requirements of
the applicable medical systems standards (see 3rd edition of
IEC 606011).
Anybody connecting additional equipment to medical electri
cal equipment configures a medical system and is therefore
responsible for the system's compliance with the requirements
for medical electrical systems. Attention is drawn to the fact
that local laws take priority over the above mentioned require
ments.
If in doubt, please consult your local dealer or ergoline GmbH.
Note
Applied Parts
Applied parts are components that are in direct
contact with the human body (e.g., sphygmoma
nometers).
Note
Stability
Ensure the stability of the ergometer. If the max
imum permitted patient weight is exceeded, the
stability of the ergometer can no longer be guaran
teed. It may become unstable as a result.
2.1 Contraindications
• The general, absolute contraindications to cardiac stress
testing apply.
• Patients with physical, psychological, or mental afflic‑
tions who cannot be mobilized and are therefore not
capable of using rehabilitation facilities.
The following patient categories are excluded from using
the device:
• dizziness, nausea, or pain
• patients under the influence of substances that may
impair vigilance (alcohol, drugs, medication).
Contraindications in exercise testing carried
out with ergometers
(source: Banerjee A et al., 2012)
Contraindications in exercise testing:
• acute myocardial infarction in the previous 4 to 6 days
• unstable angina with rest pain in the previous 48 hours
• uncontrolled heart failure
• acute myocarditis or pericarditis
• acute systemic infection
• deep vein thrombosis as it is likely to shift and cause
pulmonary embolism
• uncontrolled hypertension with systolic blood pressure
> 220 mmHg or diastolic blood pressure > 120 mmHg
• severe aortic stenosis
• severe hypertrophic obstructive cardiomyopathy
• untreated life‑threatening arrhythmia
• dissecting aneurysm
• recent aortic surgery
• abnormalities during testing include:
− abnormal ST‑segment response (horizontal, planar,
or down‑sloping depression of > 1 mm).
− T‑wave elevation of > 1 mm in non‑Q‑wave leads.
− T‑wave changes such as inversion and pseudo‑nor‑
malization when an inverted T‑wave becomes
upright are non‑specific changes.
Criteria for stopping bicycle-based exercise
testing
(source: Banerjee A et al., 2012).
Criteria for stopping bicycle based exercise testing include:
ECG criteria
• severe ST depression of > 3 mm
• ST elevation > 1 mm in non‑Q‑wave lead
• frequent ventricular extra systoles
• onset of ventricular tachycardia
• new atrial fibrillation or supraventricular tachycardia
• development of new bundle branch block
• progression of heart block to second or third degree
• cardiac arrest
