intended use, contraindications, risks
&
forbidden use
file: n:\article\cos14310m5-v1_08hpc-en\20150130_cos14310m5-v1.08hpc-en_instructions_for_use_h-p-cosmos_treadmill.doc
© 2015 h/p/cosmos sports & medical gmbh author: fh [email protected] created 30.01.2015 printed 30.01.2015 page: 17 of 216
3.3
Risks
In the event of overload of the patient due to wrong application and/or wrong assessment and/or unexpected problems,
the following risks, problems and injuries may occur. Risks are reduced by correct load dosing (according to the clinical
picture and condition of the patient). Especially for ergometry (stress-test) application, the patient is subject to additional
risk since the test is designed to stress the patient until cardiovascular problems may occur. The risk remains even in
the presence of trained, medical staff and even when medical equipment and a defibrillator for reanimation are
available. The higher risk cannot be reduced even with the knowledge of contraindications. Neither can loading capacity
nor cognition restrictions be excluded by contraindications.
The risk of falling and consequential injuries is reduced by the safety equipment and application of a fall prevention
system.
Remaining risks in ergometry / stress testing
The following complications are mentioned in the “Praxisleitlinien Ergometrie”:
(Wonisch M, Berent R, Klicpera M, Laimer H, Marko C, Pokan R, Schmid P, Schwann H. [Practice Guidelines for
ExerciseTesting], J Kardiol 2008; 15 (Suppl A): 3-17)
Cardiac complications
Frequency
Morbidity
< 0.05 %
Lethal complications
0.03 – 0.04 %
Non-lethal complications
0.07 – 0.15 %
Acute MCI
0.035 – 0.1 %
Acute cardiac death
< 0.005 %
Ventricular tachyarrhythmia
0.05 % - 2.3 %
Supraventricular tachyarrhythmia
- in case of known paroxysmal
supraventricular arrhythmia
- atrial fibrillation, atrial flutter
3.4 – 15 %
< 1 %
Ventricular extrasystoly
2 – 20 %
Supraventricular extrasystoly
4 – 24 %
Paroxysmal atrial fibrillation
0.8 %
Transient left bundle-branch block
0.4 %
Bradyarrhythmia
Hypotony
3 – 9 %
Hypertensive blood pressure
regulation
n.s.
Ventricular rupture
n.s.
Papillary muscle rupture
n.s.
Non-cardiac complications
Intracranial haemorrhage
n.s.
Thromboembolic event
n.s.
Transient global amnesia
n.s.
Arthralgia
n.s.
Myalgia
n.s.
Low back pain
n.s.
n.s.: not specified
