Instructions for Use
Spirostik
Serial no.: xx|8|001|yyy and 2001xxxxx
Version: 6 | Release date: 14. July 2021
Page 17
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 Spirostik. 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 Spirostik is used by
their employees (users).
User
is a medically trained specialist who is familiar with spirometry
examinations, who uses Spirostik on the patient after verifiable
instruction by the responsible organisation and / or is
responsible for rectifying faults to the Spirostik, 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 Spirostik.
Trainee medical specialists must also be supervised in addition
to receiving training in how to use Spirostik.
Operator
is a person who has received instruction on cleaning Spirostik
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.
