Instructions for Use
Ergostik Blueflow
Serial no.: xx|8|201|yyy and 2203xxxxx
Page 22
Version: 6 | Release date: 02 August 2022
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 Blueflow. 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 Blueflow is
used by their employees (users).
User
is a medically trained specialist who is familiar with cardio-
pulmonary exercise tests, who uses Ergostik Blueflow on the
patient after verifiable instruction by the responsible organisation
and / or is responsible for rectifying faults to the Ergostik
Blueflow, 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 Blueflow.
Trainee medical specialists must also be supervised in addition
to receiving training in how to use Ergostik Blueflow.
Operator
is a person who has received instruction on cleaning Ergostik
Blueflow by a medically trained specialist.
