2 Definitions
ers2 – 1-Channel ECG Telemetry System 11
201000401000 / Rev 04
2.2.2 Patient Characterization
Indications
• Adult patients whose electrical activity of the heart needs to be continuously monitored to control
the training sessions.
Contraindications
• The general, absolute contraindications to cardiac stress testing (according to the ergometry
guidelines, DGSP (German Sports Physicians Association)) apply.
Acute myocardial infarction
Unstable angina
Cardiac arrhythmia causing symptoms and/or hemodynamic instability
Symptomatic severe aortic stenosis
Decompensated heart failure
Acute pulmonary embolism
Acute myocarditis
Acute pericarditis
Acute aortic dissection
• Patients with physical, psychological, or mental afflictions who cannot be mobilized and are
therefore not capable of using rehabilitation facilities.
Application
• Applied parts are only used on healthy, intact skin.
• The application is transient (less than 60 minutes under normal conditions), cumulative use for
20 training sessions.
2.2.3 Characterization of the Environment of Use
The ECG system is intended for use in medical training therapy for inpatient and outpatient care in
professional healthcare institutions.
2.2.4 Essential Performance
The 1-channel system fulfills the applicable requirements of IEC 60601-2-27 for the essential perfor-
mance of electrocardiographic monitoring equipment regarding signal accuracy and protection against
the effects of defibrillation. As defined by its intended purpose, the device can be used to monitor the
cardiac rhythm and calculate the heart rate during training units in rehabilitation therapy.
Equipment (typically used to perform the tasks): Application software, ECG maintenance soft-
ware, ECG simulator
Expected training (related to the medical device): One 1-hour training session by manufacturer
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