Instructions for Use
Diffustik / Variant PFTstik
Serial no.: xx|8|401|yyy and 2401xxxxx
Page 18
Version: 8 | Release date: 16. August 2021
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 Diffustik resp. the variant PFTstik. They are
responsible for instructing the user 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 Diffustik resp. the variant
PFTstik is used by their employees (users / operators).
User
is a medically trained specialist who is familiar with spirometry
examinations, who uses Diffustik resp. the variant PFTstik on the
patient after verifiable instruction by the responsible organisation
and / or is responsible for rectifying faults to the Diffustik resp.
the variant PFTstik, 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 Diffustik resp. the
variant PFTstik.
Trainee medical specialists must also be supervised in addition
to receiving training in how to use Diffustik resp. the variant
PFTstik.
Operator
is a person who has received instruction on cleaning Diffustik
resp. the variant PFTstik 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. The persons can be adults without an
age limitation as well as children form 4 years of age.
A requirement for carrying out the examination is the ability to
follow the instructions of the user.
