Instructions for Use
Ergostik Blueflow
Serial no.: xx|8|201|yyy and 2203xxxxx
Page 20
Version: 6 | Release date: 02 August 2022
2.1.2.2
Side Effects
If there are no contraindications and the examination is carried
out in accordance with the descriptions in the IFU, cardio-
pulmonary exercise testing is a safe examination, but in rare
cases (1 per 10,000 examinations) serious cardiac incidents and
death (2-5 per 100,000 examinations) can occur. Therefore, the
following safety measures must be observed when conducting
cardio-pulmonary exercise tests:
•
Presence of a physician for timely detection and
assessment of termination criteria (see table below)
•
Presence of emergency equipment (defibrillator,
emergency medication)
•
Availability of emergency medically trained personnel for
assistance
The following side effects may also occur:
Side effect / Frequency
Rules of conduct
Exhaustion / Frequent
Stopping the exercise after medical
assessment.
Shortness of breath /
Frequent
Stopping the exercise after medical
assessment.
Chest pain / Frequent
Stopping the exercise after medical
assessment, monitoring of the patient for
cardiac events and, if necessary, treatment of
these.
Cardiac arrhythmias /
Frequent
Stopping the exercise after medical
assessment, monitoring of the patient for
cardiac incidents and treatment of these if
necessary.
Bronchospasm / Rare
Stopping the exercise after medical
assessment, monitoring of the patient after the
examination and administration of a
bronchodilator if necessary.
