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Summary of Contents for GERATHERM Ambistik
- Page 1 Ambistik Serial numbers: xx|4500|004|yyy Instructions for Use Version: 6 Release date: 14. July 2021 Please read carefully and store in a place which is always accessible for future consultation!
- Page 2 14. July 2021 Filename: TDOAMB0034R6 Language: English Affected serial numbers: xx|4500|004|yyy Software version: valid from 1.1.0 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 EUDAMED SRN: © Geratherm® Respiratory GmbH DE-MF-000006818...
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Page 3: Table Of Contents
Safety in Handling ..............18 General Safety at Work and Personnel Qualification ..... 19 Storage Conditions stipulated by the Manufacturer ...... 20 The Technical State of Ambistik and System Construction ... 20 Operation / Servicing and Maintenance ........22 Electromagnetic Compatibility (EMC) ..........24 Cleaning and Disinfection ............. - Page 4 12.2 Installation and Operating Conditions ........... 46 12.3 Electrical Safety Concept .............. 47 12.3.1 Ambistik with Medical Device Cart and Isolation Transformer ..47 12.3.2 Ambistik without Medical Device Cart and without Isolation Transformer .................. 48 12.4 Electromagnetic Compatibility / EMC Guidelines ......49 12.4.1...
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Page 5: General Information
Serial no.: xx|4500|004|yyy Foreword Thank you for purchasing a medical device from Geratherm® Respiratory GmbH. Ambistik is 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®... -
Page 6: Abbreviations
Abbreviations The following simplified style of writing and abbreviations are used hereinafter to make this IFU easier to read. Instructions for Use IFU Geratherm® Respiratory GmbH Manufacturer Medical specialist personnel User(s) Personnel instructed in cleaning / maintenance work ... -
Page 7: Explanations
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 Ambistik or may indicate that something in Attention its environment may be damaged. -
Page 8: Symbols
Instructions for Use Ambistik Serial no.: xx|4500|004|yyy Symbols Symbols displayed in this IFU, on the medical device itself and / or on its packaging are standardised symbols. Symbol Explanation Follow the instructions for use! Only use indoors! IP20 Protection type (safe environmental conditions) - Page 9 Instructions for Use Ambistik Serial no.: xx|4500|004|yyy Symbol Explanation Manufacturer This symbol identifies the manufacturer of a product. Date of manufacture This symbol indicates the date on which a product is manufactured. Conformity mark This symbol indicates conformity with health, safety and environmental protection standards for products sold within the European Economic Area (EEA).
- Page 10 Instructions for Use Ambistik Serial no.: xx|4500|004|yyy Symbol Explanation Atmospheric pressure limitation The product can be safely transported, stored or operated within the permissible atmospheric pressure. Page 10 Version: 6 | Release date: 14. July 2021...
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Page 11: Copyright
Instructions for Use Ambistik Serial no.: xx|4500|004|yyy 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. -
Page 12: Conditions Of Use
Ambistik Serial no.: xx|4500|004|yyy Conditions of Use Any other use of Ambistik which is not described in this IFU is deemed improper use. The responsible organisation of Ambistik alone is liable for any direct or indirect damage resulting from not adhering to these conditions. They are then... -
Page 13: Definition Of The Groups Of People
Responsible Organisation is any natural or legal person who is responsible for the operation of the health institution where Ambistik is used by their employees (users / operators). User is a medically trained specialist who is familiar with lung function... -
Page 14: Intended Use
11.1 "Expected Service Life") and the maintenance work required for this (see chap. 8 "Servicing / Maintenance"). The Ambistik may only be used for the duration of its service life if the specifications are observed. Any changes to Ambistik, in particular unauthorised modifications, are prohibited. -
Page 15: Original Spare Parts / Accessories / Optional Expansions
The installation or use of other products can, under certain circumstances, negatively change constructive prescribed properties of Ambistik and, in the worst case, impair the safety of the patient, user / operator and / or third parties. The manufacturer assumes no liability for such consequences. -
Page 16: 2.2.1.1 Original Spare Parts / Accessories
• Instructions on safe system construction in chap. 4.1.2 of this IFU • Further information on Ambistik in the separate Ambistik Page 16 Version: 6 | Release date: 14. July 2021... -
Page 17: Auxiliary Materials
Instructions for Use Ambistik Serial no.: xx|4500|004|yyy Component Description / name Supply scope in units Ambistik 884000 [old:40.300] USB 2.0 ambient conditions module for accurate online BTPS conditions. Continuous measurement of ambient temperature, pressure and humidity. Runs on modular and... -
Page 18: Safety In Handling
In spite of this, dangers of injury to operators / users, patients and third parties as well as damage to Ambistik or other materials may occur if this is: •... -
Page 19: General Safety At Work And Personnel Qualification
Always comply with general national regulations on accident prevention! Instruct users / operators accordingly! • Safety and warning information on Ambistik may not be altered or removed! Have missing or not readable information replaced immediately! • When working with auxiliary materials, always... -
Page 20: Storage Conditions Stipulated By The Manufacturer
Reason: Measurement error due to leakage caused by incorrect assembly of components. Therefore: • Carefully observe the assembly instructions! The Technical State of Ambistik and System Construction Possible danger to life. Reason: Electric shock. Cross-contamination. Misdiagnosis caused by measurement error. - Page 21 If a maintenance schedule is exceeded, do not continue to use the complete system! Request maintenance work from your authorised specialist retail partner! For this: Only use Ambistik within its performance limits! Therefore: • Only use accessories, components and consumable materials which have been...
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Page 22: Operation / Servicing And Maintenance
Therefore: • In principle, observe chap. 12 “Technical Specifications”! • Do not operate Ambistik if there are flammable or explosive gases in the room! • Do not operate Ambistik near the magnetic field of an MRI system! Possible danger to life. - Page 23 Reason: Penetrating liquid. Uncleanliness. External exposure. Condensation Therefore: • Do not use any liquids near Ambistik! • Do not expose Ambistik or the entire system to dust or other contamination! • Do not drop any objects on Ambistik! • Do not lay any objects on it! •...
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Page 24: Electromagnetic Compatibility (Emc)
Therefore: • While using Ambistik, do not use any transmitting devices (e.g. mobile phones, portable phones, power lines …) within close proximity (< 30 cm) that exceed the immunity levels as specified in the EMC guidelines! •... -
Page 25: Cleaning And Disinfection
Attention • Do not place Ambistik in the cleaning and disinfection solution! The device contains electrical components that will be damaged by doing this! Reason: Ambistik sensors are precise and high-resolution components. For this: Ensure the respective functions are preserved! Therefore: •... -
Page 26: Structure And General Function Of Ambistik
Instructions for Use Ambistik Serial no.: xx|4500|004|yyy Structure and General Function of Ambistik Hardware 4.1.1 Overview Ambistik Docking station with data connection port and power connection port (see also chap. 4.1.2) USB cable Type label (see also chap. 14) Page 26... -
Page 27: System Construction And Electrical Safety
Independent of this, the following should also be observed: Possible danger to life. Reason: Electric shock. Misdiagnosis. Therefore: • Do not modify or use the Ambistik or complete system contrary to the respective manufacturer's specification! Version: 6 | Release date: 14. July 2021... - Page 28 (interfaces, plugs, etc.) that are not isolated from the mains with an isolation voltage of 4 kV! • When connecting Ambistik to other devices, make sure that all connections and cables are secured and cannot come loose by themselves! •...
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Page 29: 4.1.2.1 Bluetooth / Computer / Printer Data Connection
• Otherwise a relative air humidity of at least 30 % is required! 4.1.2.1 Bluetooth / Computer / Printer Data Connection The Ambistik only communicates with the diagnostic software platform for pulmonary function BLUE CHERRY®. For further information see: •... -
Page 30: Technical Protection Measures
Instructions for Use Ambistik Serial no.: xx|4500|004|yyy Technical Protection Measures Ambistik has been designed and built in accordance with the recognised state of technology and the requirements of the applicable, safety-relevant regulations. The technical safety condition is checked by the authorised... -
Page 31: Transport, Storage And Assembly
Transport, Storage and Assembly Transport to the Location of Use Ambistik is secured against damage during transport in a carton. The packaging must be kept by the user / operator in case the device must be returned to the authorised specialist retail partner or manufacturer. -
Page 32: Assembly
For further information see • Chap. 4.1.2 “System Construction and Electrical Safety” Assembly work is not required for the initial operation of Ambistik, as this is supplied in a ready-for-operation state. Page 32 Version: 6 | Release date: 14. July 2021... -
Page 33: Operation
Ambistik Serial no.: xx|4500|004|yyy Operation The initial operation of Ambistik, as well as any return to operation after service work in accordance with the duties of the responsible organisation (see chap. 8 “Servicing / Maintenance”), may be carried out by the responsible organisation's own authorised specialist personnel. -
Page 34: System Overview
USB cable [3]. In order to capture the ambient conditions as accurately as possible, the docking station with the Ambistik is placed in a well- ventilated area near the patient. It must be ensured that there is no heat source in the immediate proximity that may distort the measurement data of the Ambistik. -
Page 35: Operating Instructions
Reason: Penetrating liquid. Uncleanliness. External exposure. Therefore: • Do not use any liquids near the Ambistik! • Do not expose Ambistik or the entire system to dust or other contamination! Attention • Do not drop any objects on Ambistik! •... -
Page 36: Initial Operating
Instructions for Use Ambistik Serial no.: xx|4500|004|yyy Initial Operating The measurements of the Ambistik are processed by the diagnostic platform BLUE CHERRY®. 1. Startup the PC and press the “BLUE CHERRY®” icon on the desktop to start the software. 2. Press the “BTPS” button to get access to the ambient conditions. -
Page 37: Servicing / Maintenance
The expected service life of Ambistik is 8 years. In its development, a great deal of value was placed on making the servicing of all device components as simple as possible. -
Page 38: Cleaning And Disinfection
The devices of the manufacturer were designed in such a way that minimal effort is required for cleaning and disinfection. This is why just a few tasks are necessary to keep Ambistik functional and clean. The following intervals apply: Component... - Page 39 Attention • Do not place Ambistik in the cleaning and disinfection solutions! The device contains electrical components that will be damaged by doing so! • Wipe off any remaining moisture with a dry cloth! •...
- Page 40 Instructions for Use Ambistik Serial no.: xx|4500|004|yyy When selecting a suitable disinfectant, please observe • chap. 2.2.2 “Auxiliary Materials” Information on the application and dosing of the disinfectant can be found in the separate manual of the respective manufacturer. The safety instructions contained must be observed.
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Page 41: Fault Indication And Repair
Ambistik Serial no.: xx|4500|004|yyy Fault Indication and Repair Simple errors which occur when using Ambistik can be recognised quickly and rectified using the following table. If you cannot find the error in the table or the problem cannot be rectified using the method described, please contact your specialist retail partner. - Page 42 Instructions for Use Ambistik Serial no.: xx|4500|004|yyy Error Rectification Ambistik is not detected. Check the USB connection. Choose a different USB port. Ambistik transmits no Check the USB connector. measurement data. Measurement data are Check installation location – install the device as not plausible.
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Page 43: Decommissioning / Disposal
11.2.2 Ambistik Ambistik is an active medical device and is thus subject to the WEEE directive 2012 / 19 / EU and the German law on electrical and electronic devices (ElektroG) for the disposal for old electrical items. -
Page 44: Technical Specifications
Instructions for Use Ambistik Serial no.: xx|4500|004|yyy Technical Specifications 12.1 Technical Data Medical device: Class I (in accordance with MDD 93 / 42 Council Directive of 14.6.1993 annex IX) Dimensions: (L) 76.5 mm x (W) 30 mm x (H) 18.5 mm... - Page 45 Instructions for Use Ambistik Serial no.: xx|4500|004|yyy Accuracy: ±10 hPa Minimum PC system requirements: Standard: at least EN 62368-1 / EN 60950 recommended EN 60601 Processor: X86 / amd64 compatible, 1 GHz or higher RAM storage: 1 GB or higher...
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Page 46: Installation And Operating Conditions
12.2 Installation and Operating Conditions The following conditions supplement chap. 2.2 "Intended Use" and must be observed to maintain the properties of the Ambistik guaranteed by the manufacturer and for the safety of the patient and operator. Storage / Transport: min. -
Page 47: Electrical Safety Concept
Instructions for Use Ambistik Serial no.: xx|4500|004|yyy 12.3 Electrical Safety Concept 12.3.1 Ambistik with Medical Device Cart and Isolation Transformer Version: 6 | Release date: 14. July 2021 Page 47... -
Page 48: Ambistik Without Medical Device Cart And Without Isolation Transformer
Instructions for Use Ambistik Serial no.: xx|4500|004|yyy 12.3.2 Ambistik without Medical Device Cart and without Isolation Transformer Page 48 Version: 6 | Release date: 14. July 2021... -
Page 49: Electromagnetic Compatibility / Emc Guidelines
12.4.1 Emitted Interference Guideline and Manufacturer Declaration Guidelines and manufacturer’s declaration – electromagnetic emissions The Ambistik is determined for operation in an electromagnetic environment as specified below. The user / operator of the Ambistik should ensure that it is operated in this environment. Measurement of Compliance Electromagnetic environment –... -
Page 50: Interference Resistance For All Me Systems Guideline And Manufacturer Declaration
Guidelines and manufacturer’s declaration – electromagnetic interference immunity The Ambistik is determined for operation in an electromagnetic environment as specified below. The user / operator of the Ambistik should ensure that it is operated in this environment. Measurement of IEC 60601 Compliance Electromagnetic environment –... -
Page 51: Interference Resistance For Non-Life-Supporting Me Systems Guideline And Manufacturer Declaration
Guidelines and manufacturer’s declaration – electromagnetic interference immunity The Ambistik is determined for operation in an electromagnetic environment as specified below. The user / operator of the Ambistik should ensure that it is operated in this environment. Measurement IEC 60601 –... - Page 52 If the measured field strength at the site where the Ambistik is used exceeds the abovementioned compliance levels, the Ambistik should be observed to demonstrate its intended function. If unusual performance characteristics are observed, additional measures may be required, such as a change in orientation or in location of the Ambistik.
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Page 53: Recommended Safety Distances For Non-Life-Supporting Me Systems
Recommended safety distance between portable and mobile RF communication devices and the Ambistik The Ambistik is determined for operation in an electromagnetic environment in which the RF disturbances are controlled. The user / operator of the Ambistik may help to avoid... -
Page 54: Safety Of Product And Material
DIN EN ISO 10993- 1:2017-04 "Biological evaluation of medical devices" (biocompatibility). Ambistik is a class I active medical device. Conformity with the underlying standards and directives is certified in the declaration of conformity which is included in the documentation accompanying the device. -
Page 55: Product Labeling / Type Label
Instructions for Use Ambistik Serial no.: xx|4500|004|yyy Product Labeling / Type Label The type label can be found on the back of the Ambistik. • See chap. 1.3 “Symbols”. Manufacturer logo Product name Product application Serial number Catalog number Manufacturer details... -
Page 56: Warranty And Service
Instructions for Use Ambistik Serial no.: xx|4500|004|yyy Warranty and Service 15.1 General Conditions The manufacturer guarantees that the products you have purchased fulfill the listed technical data and that the medical devices are free from technical material and production defects. -
Page 57: Packaging And Shipping
Instructions for Use Ambistik Serial no.: xx|4500|004|yyy 15.3 Packaging and Shipping To avoid damage during transport, devices must be sent along with the warranty claim in the original packaging. This also applies for defective devices being repaired. Transport damage arising from improper packing is the responsibility of the customer. -
Page 58: Authorised Specialist Retail Partner
Instructions for Use Ambistik Serial no.: xx|4500|004|yyy Authorised Specialist Retail Partner You can reach your responsible specialist retail partner via a contact form of the manufacturer www.geratherm-respiratory.com/login/ See depositors Page 58 Version: 6 | Release date: 14. July 2021... -
Page 59: Attachment - Declaration Of Conformity
Instructions for Use Ambistik Serial no.: xx|4500|004|yyy Attachment – Declaration of Conformity The Ambistik declaration of conformity is enclosed with each device by the manufacturer. Version: 6 | Release date: 14. July 2021 Page 59...
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