Instructions for Use
Spirostik Complete
Serial no.: xx|8|102|yyy and 2103xxxxx
Page 6
Version: 7 | Release date: 14. July 2021
Foreword
Thank you for purchasing a medical device from Geratherm®
Respiratory GmbH. Spirostik Complete 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 Complete 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 Complete, 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
Complete 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 Complete. 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.
