Instructions for Use
Spirostik Complete
Serial no.: xx|8|102|yyy and 2103xxxxx
Page 30
Version: 7 | Release date: 14. July 2021
Reason: Disregard of a contraindication. Misdiagnosis
caused by measurement error. Cross-contamination.
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)!
•
Do not use single use products more than once!
3.4
Electromagnetic Compatibility (EMC)
Possible danger to life.
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!
•
No stacking of devices on top of each other and
no close arrangement. Observe the installation
and operating conditions from the manufacturer!
•
Check the correct function of the Spirostik
Complete!