Instructions for Use
Ambistik PFT-CPET
Serial no:
2024xxxxx / 2025xxxxx
Page 14
Version: 1 | Release date: 31 January 2022
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 Ambistik PFT / Ambistik CPET. They are
responsible for instructing the users in relation to this via the
corresponding specialist retailer’s partner.
Responsible Organisation
is any natural or legal person who is responsible for the
operation of the health institution where Ambistik PFT / Ambistik
CPET is used by their employees (users / operators).
User
is a medically trained specialist who is familiar with lung function
examinations, who uses Ambistik PFT / Ambistik CPET after
verifiable instruction by the responsible organisation and / or is
responsible for rectifying faults to the Ambistik PFT / Ambistik
CPET.
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 Ambistik PFT /
Ambistik CPET. Trainee medical specialists must also be
supervised in addition to receiving training in how to use
Ambistik PFT / Ambistik CPET.
Operator
is a person who has received instruction on cleaning Ambistik
PFT / Ambistik CPET 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.
