Instructions for Use
Ergostik
Serial no.: xx|8|201|yyy and 2201xxxxx
Page 20
Version: 7 | Release date: 02. August 2021
As the transitions between absolute and relative
contraindication can be fluid in the assessment, the assertion of
a physician should be regarded as binding.
(Source: Deutsche Gesellschaft für Kardiologie. 2000. Leitlinien zur Ergometrie.
Z Kardiol. 89:821–837.)
2.1.3
Definition of the Groups of People
Groups of people named in this IFU are defined as follows:
Manufacturer
specifies all measures to ensure the safe and proper handling
and application of Ergostik. They are responsible for instructing
the operator in relation to this via the corresponding specialist
retail partner.
Responsible Organisation
is any natural or legal person who is responsible for the
operation of the health institution where Ergostik is used by their
employees (users).
User
is a medically trained specialist who is familiar with cardio-
pulmonary exercise tests, who uses Ergostik on the patient after
verifiable instruction by the responsible organisation and / or is
responsible for rectifying faults to the Ergostik, as well as its
calibration.
Users must be aware of the clinical meaning and, for example,
be a physician, physician’s assistant, assistant or trained
maintenance personnel with basic electrical or mechanical
training. The user is able to identify, assess and, in the best
case, to avoid possible hazards when using Ergostik.
Trainee medical specialists must also be supervised in addition
to receiving training in how to use Ergostik.
Operator
is a person who has received instruction on cleaning Ergostik by
a medically trained specialist.
