Instructions for Use
Diffustik / Variant PFTstik
Serial no.: xx|8|401|yyy and 2401xxxxx
Page 6
Version: 8 | Release date: 16. August 2021
Foreword
Thank you for purchasing a medical device from Geratherm®
Respiratory GmbH. Diffustik and the variant PFTstik are a part of
our product family with solutions for cardiopulmonary function
diagnostics which are operated using the common software
platform BLUE CHERRY®. This means that you have the option
of optimising the working processes in your practice using the
networked application of further products from Geratherm®
Respiratory GmbH, and to benefit from the simple use of our
products.
1
General Information
All our medical devices are manufactured and tested in
accordance with certified quality standards. This means that
Diffustik and the variant PFTstik fulfills the regulatory
requirements for medical devices (class IIa).
This IFU is a component of the product in accordance with DIN
EN ISO 60601-1. It should make it easier to familiarise yourself
with Diffustik resp. the variant PFTstik, as well as give you
instructions about its intended use and safe operation.
This IFU has been written for healthcare professionals who are
qualified to perform spirometric examinations.
The basic prerequisite for safe working with the Diffustik resp.
the variant PFTstik is to follow all the safety instructions given.
In addition to the notes in this IFU, the local accident prevention
regulations and the national industrial safety regulations apply.
Read this IFU carefully and in its entirety before using Diffustik
resp. the variant PFTstik. For future reference, keep them in
the immediate vicinity of the medical device, ready at hand for
the user / operator and accessible at all times!
Please refer to the separate instructions for use of the
BLUE CHERRY® software platform for pulmonary function
diagnostics.
