Instructions for Use
Spirostik
Serial no.: xx|8|001|yyy and 2001xxxxx
Version: 6 | Release date: 14. July 2021
Page 29
3.2
The Technical State of Spirostik and System Construction
Possible danger to life.
Reason: Electric shock. Cross-contamination.
Misdiagnosis caused by measurement error.
Therefore:
•
Do not overstress Spirostik! Use with care!
•
Do not modify or use Spirostik or total system
contrary to the respective manufacturer's
specification!
•
Only use Spirostik within its expected service life,
determined by the manufacturer!
•
Under no circumstances use or connect any
devices, systems, equipment and other products
that are not part of the total system! This also
includes only components approved by the
manufacturer such as (connection) cables and
computers that are not permitted by the
manufacturer. See chap. 12 "Technical
Specifications"!
•
Do not connect any other Bluetooth devices
which have not been approved by the
manufacturer!
•
Do not install any other software!
•
Ensure that in the patient environment – a
distance of 1.5 meters to the patient
−
there are
no accessible electrical parts (interfaces, plugs,
etc.) that are not isolated from the mains with an
isolation voltage of 4 kV!
•
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!
