Instructions for Use
Spirostik
Serial no.: xx|8|001|yyy and 2001xxxxx
Page 6
Version: 6 | Release date: 14. July 2021
Foreword
Thank you for purchasing a medical device from Geratherm®
Respiratory GmbH. Spirostik is 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
Spirostik 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 Spirostik, 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 Spirostik 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
Spirostik. 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.
