Diffustik (incl. system variant PFTstik) Serial numbers: xx|8|401|yyy and 2401xxxxx Instructions for Use Version: 14 Release date: 21 July 2022 Please read carefully and store in a place which is always accessible for future consultation!

Version: Release date: Filename: Language: Affected serial numbers: Software version: Geratherm® Respiratory GmbH Kasernenstraße 4 97688 Bad Kissingen, GERMANY Tel.: +49 971 7857043-0 Fax: +49 971 7857043-30 [email protected] www.geratherm-respiratory.com © Geratherm® Respiratory Gmb

Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx Version: 14 | Release date: 21 July 2022

Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx Version: 14 | Release date: 21 July 202

Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx Version: 14 | Release date: 21 July 2022

Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx Version: 14 | Release date: 21 July 2022

Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx 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. General...

Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx If, in spite of careful reading of this IFU, you require more information, please contact your specialist retail partner on site. You can obtain the contact details via a form provided by the manufacturer at www.geratherm-respiratory.com/login/. Abbreviations The following simplified style of writing and abbreviations are used hereinafter to make this IFU easier to read. Instructions for Use Geratherm® Respiratory GmbH Medical specialist personnel Personnel instructed in cleaning / maintenance work  IFU ...

Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx Indicates a directly hazardous situation. Not observing and not avoiding the situation will lead to death or severe injuries. The signal word DANGER is only used for extreme situations. Indicates a possibly hazardous situation. Not observing and not avoiding the situation may lead to death or severe injuries. Indicates a possibly hazardous situation. Not observing and not avoiding the situation may lead to minor or moderate injuries. Not observing this warning information may lead to faults or malfunctions...

Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx Symbols Symbols displayed in this IFU, on the medical device itself and / or on its packaging are standardised symbols. Explanation Follow the instructions for use! Applied part from type BF corresponding to DIN EN 60601-1 The applied part is in direct contact with the patient (BF: Body Floating). In order to comply with the limit value for the patient leakage current, the applied part is insulated from earth. Only use indoors! Protection type (safe environmental conditions) IP2x: Protection of enclosure against...

Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx Explanation Do not dispose of the device along with general household waste! It must be disposed of in a proper and correct manner via the specialist retail partner. By marking a device with this symbol, the manufacturer also declares that he fulfills all the requirements of the law on the distribution, return and environmentally friendly disposal of electrical and electronic devices. (Rechargeable) batteries must be taken to a central collection point for used batteries or to the manufacturer. For single...

Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx Explanation Conformity mark This symbol indicates conformity with health, safety and environmental protection standards for products sold within the European Economic Area (EEA). The additional four-digit number identifies the Notified Body involved in the conformity evaluation procedure of this product. In this case 0494 identifies SLG Prüf- und Zertifizierungs GmbH as Notified Body. Caution, non-ionizing electromagnetic radiation Precautions must be taken to avoid an unexpected effect of non-ionizing radiation....

Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx Copyright The manufacturer reserves all rights to this document and the information contained therein. No part of this document or the information contained herein may be reproduced or transmitted without the written consent of the manufacturer. All information or brand names of a third party contained in this document are subject to the copyright of that third party. Limitation of Liability The manufacturer emphasises the creation of accompanying documents for his products. Despite careful checking, errors...

Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx Conditions of Use Any other use of Diffustik resp. the variant PFTstik which is not described in this IFU is deemed improper use. The responsible organisation of Diffustik resp. the variant PFTstik alone is liable for any direct or indirect damage resulting from not adhering to these conditions. They are then solely responsible for the fulfillment of the basic requirements of the medical device and assumes complete product liability for the whole system. Intended Purpose For the Diffustik variant, the separate...

Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx For a detailed description of the option ”CO Diffusion“, please refer to the separate IFU: • Add-on CO Diffusion Required option Variant Diffustik: Included Variant PFTstik: Add-on CO Diffusion ( Breathing Pattern Analysis You can find more information in: • IFU Spirometry for carrying out the examination • IFU BLUE CHERRY® for the general operation of the software and carrying out the examination Version: 14 | Release date: 21 July 2022