Manual Bodystik™ Bodyplethysmograph
114Pages

Bodystik Serial numbers: xx|8|301|yyy and 2301xxxxx Instructions for Use Version: 11 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 info@geratherm-respiratory.com www.geratherm-respiratory.com © Geratherm® Respiratory Gmb

Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx Version: 11 | Release date: 21 Juli 2022

Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx Version: 11 | Release date: 21 Juli 2022

Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx Version: 11 | Release date: 21 Juli 2022

Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx Version: 11 | Release date: 21 Juli 2022

Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx Foreword Thank you for purchasing a medical device from Geratherm® Respiratory GmbH. Bodystik 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 optimizing 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 Information All our medical devices are...

Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx Please refer to the separate IFU of the BLUE CHERRY® software platform for pulmonary function diagnostics. 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...

Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx 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 of the Bodystik...

Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx 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 ingress of...

Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx Explanation For single use only! This symbol does not refer to the Bodystik itself, but to the consumable items used in connection with it. This is applied to the respective packaging and must be observed. Batch number This symbol identifies the batch or lot code given by the manufacturer. The code is placed adjacent to the symbol. Serial number This symbol identifies the serial number given by the manufacturer. Catalog number This symbol identifies the catalog number given by the manufacturer. Manufacturer This symbol...

Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx Explanation Fragile, handle with care The package contains a product that must be handled with appropriate care to prevent damage during transport and storage. Keep away from rain The package contains a product that must be protected from moisture during transport and storage. Temperature limitation The product can be safely transported, stored or operated within the specified temperature range. Humidity limitation The product can be safely transported, stored or operated within the specified humidity range. Atmospheric...

Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx 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 or inaccuracies...

Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx Conditions of Use Any other use of Bodystik which is not described in this IFU is deemed improper use. The responsible organisation of Bodystik 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 The Bodystik is a medical electrical device. As a PC connected bodyplethysmograph, it is mainly intended...

Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx You can find more information in: • IFU Spirometry and Bodyplethysmography for carrying out the examination. • IFU BLUE CHERRY® for the general operation of the software and carrying out the examination. 2.1.1 Indication With the Bodystik bodyplethysmographic examinations can be performed for diagnosis, follow-up, screening and severity assessment of pulmonary diseases. In particular, this includes: Obstructive diseases • • • • Complaints such as dyspnea (shortness of breath) or coughing when at rest as well as under...