Instructions for Use
Spirostik Complete
Serial no.: xx|8|102|yyy and 2103xxxxx
Page 56
Version: 7 | Release date: 14. July 2021
7.5
Using Spirostik Complete / Carrying Out Measurements
For further information see:
•
The separate IFU Spirometry
•
The separate IFU BLUE CHERRY®
Possible danger to life.
Reason: Ignoring a contraindication.
Misdiagnosis caused by measurement error. For this:
Observe the general medical principles!
Therefore:
•
Inform yourself and observe the respective
contraindications before each test!
•
When carrying out tests, observe the content of
the applicable guidelines and recommendations
(e.g. ATS / ERS Guidelines)!
•
Replace the flow sensor immediately in case of
saliva or moisture inside the flow sensor!
Reason: Misdiagnosis due to measurement error
caused by a system failure due to uncontrollable
electromagnetic fields of inadmissible transmitting
devices. Therefore:
•
While using Spirostik Complete, do not use any
transmitting devices (e.g. mobile phones, portable
phones, power lines …) within close proximity (<
30 cm) that exceed the immunity levels as
specified in the EMC guidelines!
•
Ask your authorised specialist retail partner about
this!
Reason: Electric shock. Therefore:
•
Ensure that the users or third party persons do
not touch the patient and any conductive
connections or parts of the device that are
located outside the patient environment at the
same time!
