Instructions for Use
Safestik
Serial no.:
2011xxxxx
Page 12
Version: 4 | Release date: 14. July 2021
2.1.1
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 Safestik. They are responsible for instructing
the users 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 Safestik is used by their
employees (users / operators).
User
is a medically trained specialist who is familiar with lung function
examinations, who uses Safestik after verifiable instruction by the
responsible organisation and / or is responsible for rectifying
faults to the Safestik.
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 Safestik.
Trainee medical specialists must also be supervised in addition
to receiving training in how to use Safestik.
Operator
is a person who has received instruction on cleaning Safestik by
a medically trained specialist.
Patient
is a person undergoing medical treatment (check-up, initial
diagnosis as well as progress / treatment monitoring) to assess
their pulmonary function.
