Instructions for Use
Ambistik PFT-CPET
Serial no:
2024xxxxx / 2025xxxxx
Page 6
Version: 1 | Release date: 31 January 2022
Foreword
Thank you for purchasing a medical device from Geratherm®
Respiratory GmbH. Ambistik PFT / Ambistik CPET is 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
Ambistik PFT / Ambistik CPET fulfills the regulatory requirements
for medical devices (class I).
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 Ambistik PFT / Ambistik CPET, 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 Ambistik PFT /
Ambistik CPET 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
Ambistik PFT / Ambistik CPET. 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 IFU of the BLUE CHERRY®
software platform for pulmonary function diagnostics.
