2 Definitions
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201000401000 / Rev 04
2.2 Intended Use
The 1-channel system is a device for recording of a single-channel, bipolar surface ECG (frontal
plane) acquired with two ECG electrodes. The ECG is transmitted to another ME device or a medi-
cal application software that processes it to continuously monitor and document the heart rate
and the cardiac rhythm and to control the training load for rehabilitation or preventive training
activities.
The signal is acquired on the intact skin of adult patients.
The medical device is intended for use in professional healthcare institutions for inpatient and
outpatient care.
2.2.1
User Characterization
2.2.1.1 Primary Users
2.2.1.2 Secondary Users
User Group:
Primary Users
Typical professional title(s):
Cardiologist, sports therapist, physiotherapist,
nurse
Expected education (formation, degree, training):
Three-year professional education and training
Expected professional experience (related to
the product, similar products or IT in general):
No product-specific professional experience
required, specified education is sufficient
Core task (related to the medical device):
Prepare patient for ECG monitoring, perform
follow-up tasks (cleaning, disinfection)
Replace battery of 1-channel transmitter
Equipment (typically used to perform the tasks):
Application software, ECG system, ECG elec-
trodes
Expected training (related to the medical device):
Approx. 30 minutes of training encompassing
application of the device and patient prepa-
ration
User Group:
Secondary Users
Typical professional title(s):
Biomedical technician, application specialist
Expected education (formation, degree, training):
Three-year professional education and train-
ing, training by manufacturer
Expected professional experience (related to
the product, similar products or IT in general):
No product-specific professional experience
required, specified education is sufficient
Core tasks (related to the medical device):
Training of primary users, firmware update of
the 1-channel transmitter, functional and
safety checks
