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Manual Bodystik™ Bodyplethysmograph
Manual Bodystik™ Bodyplethysmograph
The Bodystik is a medical device for cardiopulmonary diagnostics, manufactured by Geratherm® Respiratory GmbH. It is a class IIa medical device intended for use by qualified healthcare professionals and operates on the BLUE CHERRY® software platform.
The device is intended for specific diagnostic purposes and must be used with original parts and accessories. It is designed for specific patient groups, and contraindications and side effects should be considered.
Emphasizes safety at work, personnel qualification, and maintaining the device's technical state. Includes guidelines for operation, servicing, maintenance, and ensuring electromagnetic compatibility.
Details hardware components, system construction, electrical safety, and technical protection measures like emergency stops.
Instructions for transporting, storing, and assembling the device to ensure correct setup.
Covers initial operation, recommissioning, and assembly of the flow measuring system, including detailed steps for use and maintenance.
Outlines responsibilities for regular checks and maintenance tasks to ensure device functionality.
Guidelines for cleaning and disinfection to maintain hygiene standards.
Describes how to identify and address faults to keep the device operational.
Details service life, decommissioning procedures, and disposal methods for the device and components.
Lists technical data, installation, and operating conditions, along with electrical safety and electromagnetic compatibility guidelines.
Discusses product labeling requirements and safety measures for regulatory compliance.
Outlines warranty conditions, exemptions, and procedures for packaging and shipping.
Confirms the device meets necessary regulatory standards.
Explains standardized symbols used in the instructions, on the device, and packaging.
Manufacturer retains rights to the document, limiting reproduction and liability for errors.
Bodystik is used for diagnosing pulmonary diseases and allergy diagnosis in clinical settings by trained professionals.
Includes contraindications like recent myocardial infarction and potential side effects such as dizziness.
Defines roles and responsibilities of Manufacturer, Responsible Organisation, User, Operator, and Patient.
Device should be used in controlled environments by trained personnel with approved accessories.
Only manufacturer-approved parts should be used to ensure safety and functionality.
The Bodystik is a USB 2.0 Bodyplethysmograph for pulmonary function testing, featuring an electromagnetic door-lock and electronic height adjustment.
Lists add-ons like CO Diffusion for additional measurements and software options.
Specifies tested consumable items like disposable nose clips and bacterial filters.
Outlines safety protocols to prevent cross-contamination and device misuse.
Emphasizes compliance with health and safety regulations and proper training for users.
Advises on correct use within performance limits and maintaining electrical safety standards.
Ensure compliance with conditions to prevent electric shock and device damage. Regular inspections and calibrations are necessary.
Avoid using transmitting devices near Bodystik to prevent interference.
Regular cleaning and disinfection are crucial to prevent cross-contamination.
Includes a pressure-stable cabin, adjustable chair, and user/patient panels.
Only authorized specialists should set up the system, ensuring compliance with safety standards.
Must meet IEC 60601 standards and use approved power supply units.
Includes protective systems activated in emergencies, with regular safety checks.
EMERGENCY OFF button disconnects power and data lines, deactivating the cabin door lock.
The cabin door can be opened by the patient in emergencies.
Uses BLUE CHERRY® software for managing patient data and conducting measurements.
Transported securely and must be unpacked by authorized specialists.
Initial operation and recommissioning after maintenance are conducted by qualified personnel.
System reset and communication re-establishment after an emergency stop.
Detailed steps for assembling the flow measuring system and shutter system.
Use manufacturer-approved power supplies and cables to avoid electric shock.
Daily checks for worn parts and regular calibration are required.
Designed for continuous operation, with specific procedures for recommissioning.
Daily and additional tests are required for accurate volume measurement.
Proper patient positioning is crucial for accurate measurements.
Avoid using transmitting devices near Bodystik to prevent interference.
Single-use items must be disposed of after each use to prevent cross-contamination.
Regular maintenance by authorized personnel is required for safety and accuracy.
Regular disinfection is necessary, with specific cleaning schedules for components.
Clean tubes externally and replace dirty ones to prevent damage.
Components in contact with patient respiratory flow must be cleaned and disinfected weekly.
Perform wipe disinfection and ensure thorough drying after cleaning.
Disassemble and clean components, ensuring no residues remain.
Common errors can be rectified by checking connections and power supply.
Expected service life of 8 years, with disposal complying with national regulations.
Class IIa medical device with specific dimensions, weight, and electrical data.
Specific temperature, humidity, and pressure ranges for storage and operation.
Must be used with a medical device cart and isolation to ensure safety.
Catalog excerpts
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!
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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
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Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx Version: 11 | Release date: 21 Juli 2022
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Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx Version: 11 | Release date: 21 Juli 2022
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Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx Version: 11 | Release date: 21 Juli 2022
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Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx Version: 11 | Release date: 21 Juli 2022
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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 manufactured...
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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 GmbH...
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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 or...
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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 solid...
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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 identifies...
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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 pressure...
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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 in...
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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 to...
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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 stress...
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