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GERATHERM Ambistik PFT Instructions For Use Manual

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Ambistik PFT /
Ambistik CPET
Serial numbers: 2024xxxxx / 2025xxxxx
Instructions for Use
Version: 1
Release date: 31 January 2022
Please read carefully and store in a place which is always accessible for future
consultation!

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Summary of Contents for GERATHERM Ambistik PFT

  • Page 1 Ambistik PFT / Ambistik CPET Serial numbers: 2024xxxxx / 2025xxxxx Instructions for Use Version: 1 Release date: 31 January 2022 Please read carefully and store in a place which is always accessible for future consultation!
  • Page 2 TDOAM2004R1 Language: English Affected serial numbers: 2024xxxxx / 2025xxxxx Software version: valid from 1.2.0 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...

  • Page 3: Table Of Contents

    Safety in Handling ..............20 General Safety at Work and Personnel Qualification ..... 21 Storage Conditions stipulated by the Manufacturer ...... 22 The Technical State of Ambistik PFT / Ambistik CPET and System Construction ................. 22 Operation / Servicing and Maintenance ........24 Electromagnetic Compatibility (EMC) ..........
  • Page 4 Installation and Operating Conditions ........... 56 12.3 Electrical Safety Concept .............. 57 12.3.1 Ambistik PFT / Ambistik CPET with Medical Device Cart and Isolation Transformer .................. 57 12.3.2 Ambistik PFT / Ambistik CPET without Medical Device Cart and without Isolation Transformer ............58 12.4...
  • Page 5 Instructions for Use Ambistik PFT-CPET Serial no.: 2024xxxxx / 2025xxxxx Product Labeling / Type Label ..........65 Warranty and Service ............67 15.1 General Conditions ............... 67 15.2 Warranty Exemption ..............67 15.3 Packaging and Shipping ............... 68 Authorised Specialist Retail Partner ........69 Attachment –...

  • Page 6: General Information

    Serial no: 2024xxxxx / 2025xxxxx Foreword Thank you for purchasing a medical device from Geratherm® Respiratory GmbH. Ambistik PFT / Ambistik CPET is a part of our product family with solutions for cardiopulmonary function diagnostics which are operated using the common software platform BLUE CHERRY®.

  • Page 7: Abbreviations

    Instructions for Use Ambistik PFT-CPET Serial no.: 2024xxxxx / 2025xxxxx 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/.

  • Page 8: 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 PFT / Ambistik CPET or may Attention indicate that something in its environment may be damaged.

  • Page 9: Symbols

    Instructions for Use Ambistik PFT-CPET Serial no.: 2024xxxxx / 2025xxxxx 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!
  • Page 10 Instructions for Use Ambistik PFT-CPET Serial no: 2024xxxxx / 2025xxxxx 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 11 Instructions for Use Ambistik PFT-CPET Serial no.: 2024xxxxx / 2025xxxxx Symbol Explanation Atmospheric pressure limitation The product can be safely transported, stored or operated within the permissible atmospheric pressure. Version: 1 | Release date: 31 January 2022 Page 11...

  • Page 12: Copyright

    Instructions for Use Ambistik PFT-CPET Serial no: 2024xxxxx / 2025xxxxx 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 13: Conditions Of Use

    Ambistik PFT-CPET Serial no.: 2024xxxxx / 2025xxxxx Conditions of Use Any other use of Ambistik PFT / Ambistik CPET which is not described in this IFU is deemed improper use. The responsible organisation of Ambistik PFT / Ambistik CPET alone is liable for any direct or indirect damage resulting from not adhering to these conditions (see chap.

  • Page 14: Definition Of The Groups Of People

    Groups of people named in this IFU are defined as follows: Manufacturer specifies all measures to ensure the safe and proper handling and application of Ambistik PFT / Ambistik CPET. They are responsible for instructing the users in relation to this via the corresponding specialist retailer’s partner.

  • Page 15: Intended Use

    Geratherm® Respiratory GmbH products via the universal software BLUE CHERRY®. (See chap. 4.1.3 “System Construction and Electrical Safety”) In all cases, the Ambistik PFT / Ambistik CPET is only intended for use in closed, pleasantly temperature-controlled (19 °C - 25 °C) rooms in a clinical area.

  • Page 16: Original Spare Parts / Accessories / Optional Expansions

    Serial no: 2024xxxxx / 2025xxxxx Electromagnetic compatibility (EMC) in accordance with EN 61000-6-1:2007 / EN 6100-6-3:2007+A1:2011+A11 / AC:2012. Ambistik PFT / Ambistik CPET is suitable for use in all institutions including those in residential areas and those which Attention are directly connected to the public supply network which also supplies buildings used for residential purposes.

  • Page 17: Original Spare Parts / Accessories

    Instructions for Use Ambistik PFT-CPET Serial no.: 2024xxxxx / 2025xxxxx Possible physical injury. Reason: Device damage as well as impurities / contamination due to improper handling of components. Therefore: • Protect separately stored components, accessories and consumable materials from unauthorised access! •...
  • Page 18 Instructions for Use Ambistik PFT-CPET Serial no: 2024xxxxx / 2025xxxxx Component Description / name Supply Supply scope in scope in units units Ambistik Ambistik CPET Ambistik PFT 654063 Ambistik CPET 493425 USB cable type-A to 104080 type-C BLUE CHERRY® Media...

  • Page 19: Auxiliary Materials

    Instructions for Use Ambistik PFT-CPET Serial no.: 2024xxxxx / 2025xxxxx 2.2.2 Auxiliary Materials You will find a list of specialist retail partners as an insert in this IFU or in your medical device book, as well as the most updated version at www.geratherm-respiratory.com/login/...

  • Page 20: Safety In Handling

    In spite of this, dangers of injury to operators / users, patients and third parties as well as damage to Ambistik PFT / Ambistik CPET or other materials may occur if this is: •...

  • Page 21: 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 PFT / Ambistik CPET may not be altered or removed! Have missing or not readable information replaced immediately! •...

  • Page 22: 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 PFT / Ambistik CPET and System Construction Possible danger to life. Reason: Electric shock. Cross-contamination. Misdiagnosis caused by measurement error.
  • Page 23 If a maintenance schedule is exceeded, do not continue to use the total system! Request maintenance work from your authorised specialist retail partner! For this: Only use Ambistik PFT / Ambistik CPET within its performance limits! Therefore: • Only use accessories, components and...

  • Page 24: Operation / Servicing And Maintenance

    Therefore: • In principle, observe chap. 12 “Technical Specifications”! • Do not operate Ambistik PFT / Ambistik CPET if there are flammable or explosive gases in the room! • Do not operate Ambistik PFT / Ambistik CPET near the magnetic field of an MRI system! Possible danger to life.
  • Page 25 Instructions for Use Ambistik PFT-CPET Serial no.: 2024xxxxx / 2025xxxxx • If there are any damages, do not operate the system. The damaged parts must be replaced or repaired properly! Reason: Misdiagnosis caused by measurement error due to incorrect components or improper use.
  • Page 26 Ambistik PFT / Ambistik CPET could be damaged. Reason: Penetrating liquid. Uncleanliness. External exposure. Condensation Therefore: • Do not use any liquids near Ambistik PFT / Ambistik CPET! • Do not expose Ambistik PFT / Ambistik CPET or the entire system to dust or other contamination! •...

  • Page 27: Electromagnetic Compatibility (Emc)

    No stacking of devices on top of each other and no close arrangement. Observe the installation and operating conditions from the manufacturer! • Check the correct function of the Ambistik PFT / Ambistik CPET! Ambistik PFT / Ambistik CPET could be damaged. Reason: Electrostatic discharges. Therefore: •...

  • Page 28: Cleaning And Disinfection

    Follow the instructions on the concentration and dwell time stated by the cleanser and disinfectant manufacturer! • Do not place Ambistik PFT / Ambistik CPET in the Attention cleaning and disinfection solution! The device contains electrical components that will be damaged by doing...

  • Page 29: Structure And General Function Of Ambistik Pft / Ambistik Cpet

    Instructions for Use Ambistik PFT-CPET Serial no.: 2024xxxxx / 2025xxxxx Structure and General Function of Ambistik PFT / Ambistik CPET Hardware 4.1.1 Overview Ambistik PFT / CPET Type label (see also chap. 14) Touch button with LED status display (see also chap. 4.1.2)

  • Page 30: Leds For Status Indication

    The LED ring indicates the operating status and status of the environmental parameters. 4.1.2.1 Function test When the Ambistik PFT / CPET is connected, the LED function test starts. The LED ring is white and starts to rotate. Should the device become defective, contact your specialist retail partner immediately.

  • Page 31: Measuring Mode

    Instructions for Use Ambistik PFT-CPET Serial no.: 2024xxxxx / 2025xxxxx Afterwards, the LED ring changes from blue rotating to blue pulsating. This phase lasts about 1:10 minutes. 4.1.2.3 Measuring mode Humidity Temperature Air pressure After the warm-up phase, the colour of the status LEDs changes in the best case to green and the device is in the temperature measuring channel.
  • Page 32 Instructions for Use Ambistik PFT-CPET Serial no: 2024xxxxx / 2025xxxxx In the general mode, a white pulsating indicator LED is not visible and the LED ring shows the status of all four measuring channels. If the LED ring colour changes to yellow, one of the measured values is in a critical range and something should be done.

  • Page 33: Error Display

    Chap. 10 "Fault Indication and Repair". Possible conditions: Display Explanation Action None Ambistik PFT / Ambistik Connect the Ambistik PFT / CPET not connected Ambistik CPET to the (LEDs off) computer's USB 2.0 port Ambistik PFT / Ambistik Connect the Ambistik PFT /...
  • Page 34 Instructions for Use Ambistik PFT-CPET Serial no: 2024xxxxx / 2025xxxxx Status LED Ambistik PFT / Ambistik Do not perform a CPET shows values beyond measurement the critical range Ambistik PFT / Ambistik Restart, correct sensor error (flashing) CPET has a communication...

  • Page 35: 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 PFT / Ambistik CPET or total system contrary to the respective manufacturer's specification! Version: 1 | Release date: 31 January 2022...
  • Page 36 • When connecting Ambistik PFT / Ambistik CPET to other devices, make sure that all connections and cables are secured and cannot come loose by themselves! •...

  • Page 37: Bluetooth / Computer / Printer Data Connection

    Otherwise a relative air humidity of at least 30 % is required! 4.1.3.1 Bluetooth / Computer / Printer Data Connection The Ambistik PFT / Ambistik CPET only communicates with the diagnostic software platform for pulmonary function BLUE CHERRY®. For further information see: •...

  • Page 38: Technical Protection Measures

    Ambistik PFT-CPET Serial no: 2024xxxxx / 2025xxxxx Technical Protection Measures Ambistik PFT / Ambistik CPET 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 39: Transport, Storage And Assembly

    Unpacking and transport to the actual place of use are the responsibility of the responsible organisation. Storage The Ambistik PFT / Ambistik CPET is a mobile, portable device. Requirements regarding space requirements, media connections and operating conditions can be found in chap. 12 "Technical specifications".

  • Page 40: Assembly

    Chap. 4.1.3 “System Construction and Electrical Safety” Assembly work is not required for the initial operation of Ambistik PFT / Ambistik CPET, as this is supplied in a ready-for- operation state. Page 40 Version: 1 | Release date: 31 January 2022...

  • Page 41: Operation

    Ambistik PFT-CPET Serial no.: 2024xxxxx / 2025xxxxx Operation The initial operation of Ambistik PFT / Ambistik CPET, 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...

  • Page 42: System Overview

    PFT / Ambistik CPET. In order to capture the ambient conditions as accurately as possible, the docking station with the Ambistik PFT / Ambistik CPET 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 PFT / Ambistik CPET.

  • Page 43: Recommissioning

    Instructions for Use Ambistik PFT-CPET Serial no.: 2024xxxxx / 2025xxxxx Recommissioning The operator is responsible for recommissioning after maintenance / cleaning work for which the user is authorised. For the steps for recommissioning correspond to the initial commissioning, see chap. 7.2 “Initial Operating".

  • Page 44: Operating Instructions

    Ambistik PFT / Ambistik CPET could be damaged. Reason: Penetrating liquid. Uncleanliness. External exposure. Therefore: • Do not use any liquids near the Ambistik PFT / Ambistik CPET! • Do not expose Ambistik PFT / Ambistik CPET or the entire system to dust or other contamination! Attention •...

  • Page 45: Initial Operating

    Instructions for Use Ambistik PFT-CPET Serial no.: 2024xxxxx / 2025xxxxx Initial Operating The measurements of the Ambistik PFT / Ambistik CPET are processed by the diagnostic platform BLUE CHERRY®. 1. Start the software. For this: Start the PC and press the "BLUE CHERRY"...

  • Page 46: Additionally For Ambistik Cpet

    Instructions for Use Ambistik PFT-CPET Serial no: 2024xxxxx / 2025xxxxx 7.2.1 Additionally for Ambistik CPET 1. Start the software. For this: Start the PC and press the "BLUE CHERRY" symbol on the desktop. The Ambistik CPET with the serial number and the measured CO...

  • Page 47: Servicing / Maintenance

    The expected service life of Ambistik PFT / Ambistik CPET 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 48: 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 PFT / Ambistik CPET functional and clean. The following intervals...
  • Page 49 Follow the instructions on the concentration and dwell time stated by the cleanser and disinfectant manufacturer! • Do not place Ambistik PFT / Ambistik CPET in the Attention cleaning and disinfection solutions! The device contains electrical components that will be damaged by doing •...

  • Page 50: Fault Indication And Repair

    Serial no: 2024xxxxx / 2025xxxxx Fault Indication and Repair Simple errors which occur when using Ambistik PFT / Ambistik CPET 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 51 Instructions for Use Ambistik PFT-CPET Serial no.: 2024xxxxx / 2025xxxxx Error Rectification Ambistik PFT / Ambistik Check the USB connection. CPET is not detected. Choose a different USB port. Check the USB connector. Ambistik PFT / Ambistik CPET transmits no measurement data.
  • Page 52 Instructions for Use Ambistik PFT-CPET Serial no: 2024xxxxx / 2025xxxxx Error Rectification Error message “Measured Check the installation location - install the device values outside the as close as possible to the patient. Do not install measuring range” the device a heat outlet of the computer (for example fan) or other devices (for example air-condition).

  • Page 53: Decommissioning / Disposal

    11.2.2 Ambistik PFT / Ambistik CPET Ambistik PFT / Ambistik CPET 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 54: Technical Specifications

    Instructions for Use Ambistik PFT-CPET Serial no: 2024xxxxx / 2025xxxxx 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 55 Instructions for Use Ambistik PFT-CPET Serial no.: 2024xxxxx / 2025xxxxx measurement: Measurement range: 0-5000 ppm Resolution: 1 ppm Scan rate: 0.03125 Hz (16s) Accuracy: +-50 ppm Pressure measurement: Measurement range: 300 – 1100 hPa Resolution: 1 hPa Scan rate: 2 Hz Accuracy: ±10 hPa...

  • Page 56: Installation And Operating Conditions

    Instructions for Use Ambistik PFT-CPET Serial no: 2024xxxxx / 2025xxxxx 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 PFT / Ambistik CPET guaranteed by the manufacturer and for the safety of the patient and operator.

  • Page 57: Electrical Safety Concept

    Ambistik PFT-CPET Serial no.: 2024xxxxx / 2025xxxxx 12.3 Electrical Safety Concept 12.3.1 Ambistik PFT / Ambistik CPET with Medical Device Cart and Isolation Transformer Ambistik PFT/CPET Power Supply and Communication via USB Interface With Isolation Transformer via Medical Device Cart Patient >...

  • Page 58: Ambistik Pft / Ambistik Cpet Without Medical Device Cart And Without Isolation Transformer

    Instructions for Use Ambistik PFT-CPET Serial no: 2024xxxxx / 2025xxxxx 12.3.2 Ambistik PFT / Ambistik CPET without Medical Device Cart and without Isolation Transformer Ambistik PFT/CPET Power Supply and Communication via USB Interface Without Medical Device Cart, without Isolation Transformer Patient >...

  • Page 59: Electromagnetic Compatibility / Emc Guidelines

    Guidelines and manufacturer’s declaration – electromagnetic emissions The Ambistik PFT / Ambistik CPET is determined for operation in an electromagnetic environment as specified below. The user / operator of the Ambistik PFT / Ambistik CPET should ensure that it is operated in this environment.

  • Page 60: Interference Resistance For All Me Systems Guideline And Manufacturer Declaration

    Guidelines and manufacturer’s declaration – electromagnetic interference immunity The Ambistik PFT / Ambistik CPET is determined for operation in an electromagnetic environment as specified below. The user / operator of the Ambistik PFT / Ambistik CPET should ensure that it is operated in this environment.

  • Page 61: Interference Resistance For Non-Life-Supporting Me Systems Guideline And Manufacturer Declaration

    Guidelines and manufacturer’s declaration – electromagnetic interference immunity The Ambistik PFT / Ambistik CPET is determined for operation in an electromagnetic environment as specified below. The user / operator of the Ambistik PFT / Ambistik CPET should ensure that it is operated in this environment.
  • Page 62 If the measured field strength at the site where the Ambistik PFT / Ambistik CPET is used exceeds the abovementioned compliance levels, the Ambistik PFT / Ambistik CPET should be observed to demonstrate its intended function.

  • Page 63: Recommended Safety Distances For Non-Life-Supporting Me Systems

    PFT / Ambistik CPET may help to avoid electromagnetic interference by keeping the minimum distance between portable and mobile RF telecommunication devices (transmitters) and the Ambistik PFT / Ambistik CPET, depending on the emitted power of the communication device as indicated below:...

  • Page 64: Safety Of Product And Material

    DIN EN ISO 10993- 1:2017-04 "Biological evaluation of medical devices" (biocompatibility). Ambistik PFT / Ambistik CPET 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 65: Product Labeling / Type Label

    Instructions for Use Ambistik PFT-CPET Serial no.: 2024xxxxx / 2025xxxxx Product Labeling / Type Label The type label can be found on the back of the Ambistik PFT / Ambistik CPET. • See chap. 1.3 “Symbols”. Manufacturer logo Product name...
  • Page 66 93 / 42 / EEC with identification of the involved notified body [13] Date of manufacture Safety symbols have been applied to the Ambistik PFT / Ambistik CPET type label. It may not be changed or removed. If information should become unreadable, the type label should be replaced immediately.

  • Page 67: Warranty And Service

    Instructions for Use Ambistik PFT-CPET Serial no.: 2024xxxxx / 2025xxxxx 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 68: Packaging And Shipping

    Instructions for Use Ambistik PFT-CPET Serial no: 2024xxxxx / 2025xxxxx 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.

  • Page 69: Authorised Specialist Retail Partner

    Instructions for Use Ambistik PFT-CPET Serial no.: 2024xxxxx / 2025xxxxx 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 Version: 1 | Release date: 31 January 2022...

  • Page 70: Attachment - Declaration Of Conformity

    Instructions for Use Ambistik PFT-CPET Serial no: 2024xxxxx / 2025xxxxx Attachment – Declaration of Conformity The Ambistik PFT / Ambistik CPET declaration of conformity is enclosed with each device by the manufacturer. Page 70 Version: 1 | Release date: 31 January 2022...

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