GERATHERM Diffustik Instructions For Use Manual
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GERATHERM Diffustik Instructions For Use Manual

Incl. system variant pftstik
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Diffustik
(incl. system variant PFTstik)
Serial numbers: xx|8|401|yyy and 2401xxxxx
Instructions for Use
Version: 8
Release date: 16. August 2021
Please read carefully and store in a place which is always accessible for future
consultation!

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Summary of Contents for GERATHERM Diffustik

  • Page 1 Diffustik (incl. system variant PFTstik) Serial numbers: xx|8|401|yyy and 2401xxxxx Instructions for Use Version: 8 Release date: 16. August 2021 Please read carefully and store in a place which is always accessible for future consultation!
  • Page 2 Language: English Affected serial numbers: xx|8|401|yyy and 2401xxxxx 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 0494 www.geratherm-respiratory.com EUDAMED SRN: © Geratherm® Respiratory GmbH DE-MF-000006818...

  • Page 3: Table Of Contents

    Structure and General Function of Diffustik resp. the Variant PFTstik ................. 40 Hardware ..................40 4.1.1 Overview of the Complete System of the Diffustik Variant ..... 40 4.1.2 Overview of the Complete System of the PFTstik Variant....41 4.1.3 Diffustik / Variant PFTstik .............. 42 4.1.3.1...
  • Page 4 Power Supply and Computer Connection ........61 Operating Instructions ............63 Checking for Worn Parts .............. 63 Switching Diffustik / Variant PFTstik On / Off ........ 64 Calibrating Diffustik / Variant PFTstik ..........64 Setting the Height-Adjustable Arm ..........65 7.4.1...
  • Page 5 12.2 Installation and Operating Conditions ........... 89 12.3 Electrical Safety Concept .............. 90 12.3.1 Variant Diffustik with Medical Device Cart and Isolation Transformer ..................... 90 12.3.2 Variant PFTstik with Medical Device Cart and Isolation Transformer91 12.4 Electromagnetic Compatibility / EMC Guidelines ......92 12.4.1...

  • Page 6: General Information

    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®.

  • Page 7: Abbreviations

    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/.
  • Page 8 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 Diffustik resp. the variant PFTstik or may Attention indicate that something in its environment may be damaged.

  • Page 9: Symbols

    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. Symbol Explanation Follow the instructions for use! Applied part from type BF corresponding to...
  • Page 10 For single use only! This symbol does not refer to the Diffustik resp. the variant PFTstik itself, but to the consumable items used in connection with it. This is applied to the respective packaging and must be observed.
  • Page 11 Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx Symbol Explanation Conformity mark This symbol indicates conformity with health, safety and environmental protection standards for products sold 0494 within the European Economic Area (EEA). The additional four-digit number identifies the Notified Body involved in the conformity evaluation procedure of this product.

  • Page 12: Copyright

    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.

  • Page 13: Conditions Of 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.
  • Page 14 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 Examination Required option CO Diffusion Variant Diffustik: Included Variant PFTstik: Add-on CO Diffusion (...

  • Page 15: Indication

    Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx 2.1.1 Indication With Diffustik resp. the variant PFTstik, pulmonary function examinations can be carried out for diagnosing, monitoring of process, screening and assessing the severity of pulmonary diseases. In particular, this includes: Obstructive diseases •...

  • Page 16: Contraindication And Side Effect

    Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx 2.1.2 Contraindication and Side Effect 2.1.2.1 Contraindications The following contraindications apply to lung function examinations: Contraindications Absolute Relative Patients with a new (< 1 month old) myocardial infarction...

  • Page 17: Side Effects

    Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx 2.1.2.2 Side Effects If there are no contraindications and the examination is carried out in accordance with the descriptions in the instructions for use, side effects rarely occur in pulmonary function examinations.

  • Page 18: Definition Of The Groups Of People

    Diffustik resp. the variant PFTstik on the patient after verifiable instruction by the responsible organisation and / or is responsible for rectifying faults to the Diffustik resp. the variant PFTstik, as well as its calibration. Users must be aware of the clinical meaning and, for example, be a physician, physician’s assistant, assistant or trained...

  • Page 19: Intended Use

    Construction and Electrical Safety". If you have any questions, please contact your local specialist dealer. In all cases, the Diffustik resp. the variant PFTstik is only intended for use in closed, pleasantly temperature-controlled (19 °C - 25 °C) rooms in a clinical area.
  • Page 20 Chapter 11.1 "Expected Service Life") and the maintenance work required for this (see chap. 8 "Servicing / Maintenance"). The Diffustik resp. the variant PFTstik may only be used for the duration of its service life if the specifications are observed.

  • Page 21: Original Spare Parts / Accessories / Optional Expansions

    The installation or use of other products can, under certain circumstances, negatively change constructive prescribed properties of Diffustik resp. the variant PFTstik and, in the worst case, impair the safety of the patient, user / operator and / or third parties.

  • Page 22: Original Spare Parts / Accessories

    Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx 2.2.1.1 Original Spare Parts / Accessories The following components can be purchased via specialist retail partners. You will find: • A list of specialist retail partners as an insert in this IFU...
  • Page 23 281404 [old:40.702-06]  Height adjustable Adapter Stand Clamp 421998  Adapter Stand Clamp to mount arm of PFTstik or Diffustik to a PFT cart. Table Clamp, Arm 420241 Can be [old:10.906]  Table Clamp to mount arm of ordered PFTstik or Diffustik to a instead of suitable table.
  • Page 24 Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx Component Description / name Supply scope in units USB-Docking Station 652725  Docking station (1.5 m) for [old:40.300-01] USB based devices. Ergoflow 139094 [old:10.600]  Re-useable lightweight flow...
  • Page 25 Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx Component Description / name Supply scope in units Shutter Plug 1* from 347975 11 / 2018 [old:40.622]  Plug to close opening for demand valve in shutter block ...
  • Page 26 Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx Component Description / name Supply scope in units Softclip 787158  Disposable noseclip [old:10.200] for lung function tests  Made of soft, skin-friendly foam for best wearing comfort ...
  • Page 27 Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx Component Description / name Supply scope in units O-Ring Set, Shutter Head 01* until 952017  O-Ring Set 11 / 2018 [old:40.616] 2 x 23.52 x 1.78 mm and 2 x 30 x 2 mm for shutter head and shutter head CO.

  • Page 28: Optional Expansions

    0 – 3000 ppm, : 0 – 3000 ppm), Demand Valve and Connection Tubes / Cable. The Add-on CO Diffusion is already included as an integral part of the Diffustik variant. Pressure Regulator, Diffusion 659623  Pressure Regulator for CO Diffusion [old:10.822]...

  • Page 29: Consumable Items / Auxilary Materials

    Maximum expiratory pressure (MEP) P0.1. 2.2.2 Consumable Items / Auxilary Materials The following items were tested by the manufacturer for Diffustik resp. the variant PFTstik. The use of other consumable items as well as auxiliary materials with different properties is deemed improper use.
  • Page 30 Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx Component Description / name Softclip 787158  Single use disposable noseclip [old:10.200] for use in pulmonary function testing.  Made of soft foam for best wearing comfort.  One size fit all.

  • Page 31: Safety In Handling

    In spite of this, dangers of injury to users / operators, patients and third parties as well as damage to Diffustik resp. the variant PFTstik or other materials may occur if this is: •...
  • Page 32 Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx In order for Diffustik resp. the variant PFTstik or the total system to be operated in accordance with its intended use, the safety information and procedures in this IFU must be understood.

  • Page 33: 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 Diffustik resp. the variant PFTstik may not be altered or removed! Have missing or not readable information replaced immediately! •...

  • Page 34: The Technical State Of Diffustik / Variant Pftstik And System Construction

    Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx The Technical State of Diffustik / Variant PFTstik and System Construction Possible danger to life. Reason: Electric shock. Cross-contamination. Misdiagnosis caused by measurement error. Therefore: • Do not overstress Diffustik resp. the variant PFTstik! Use with care! •...
  • Page 35 (ergoline ergocar PC) offered by manufacturer! Reason: Electrical shock. Therefore: • Only connect the Diffustik resp. the variant PFTstik to a supply system with a protective earth conductor! Version: 8 | Release date: 16. August 2021...

  • Page 36: Operation / Servicing And Maintenance

    • When using the optional diffusion measurement, note the separate IFU Add-on CO Diffusion! • Do not operate Diffustik resp. the variant PFTstik if there are flammable or explosive gases in the room! • Do not operate Diffustik resp. the variant PFTstik near the magnetic field of an MRT system! Possible danger to life.
  • Page 37 Therefore: • Calibrate the Diffustik resp. the variant PFTstik at the specified intervals! • Do not let any objects fall on the Diffustik resp. the variant PFTstik! • Do not put any objects on the Diffustik resp. the variant PFTstik! •...

  • Page 38: Electromagnetic Compatibility (Emc)

    Therefore: • While using Diffustik resp. the variant PFTstik, do not use any transmitting devices (e.g. mobile phones, portable phones, power lines …) within close proximity (< 30 cm) that exceed the...

  • Page 39: Cleaning And Disinfection

    Possible danger to life. Reason: Cross-contamination. For this: Observe the general medical principles! Therefore: • Clean and disinfect the Diffustik resp. the variant PFTstik and its reusable components as instructed by the manufacturer at regular intervals as specified! Possible severe physical injury.

  • Page 40: Structure And General Function Of Diffustik Resp. The Variant Pftstik

    Structure and General Function of Diffustik resp. the Variant PFTstik Hardware For the Diffustik variant, or when the "CO Diffusion" option is added to the PFTstik variant, the complete system also includes the components described in the separate IFU Add-on CO Diffusion.

  • Page 41: Overview Of The Complete System Of The Pftstik Variant

    [3] Connections for gas sample and gas supply CO Diffusion (see also chap. 4.1.3.3 [4] Diffustik / Variant PFTstik (see also chap. 4.1.2) [5] Type label on the bottom of the case (see also chap. 14) Version: 8 | Release date: 16. August 2021...

  • Page 42: Diffustik / Variant Pftstik

    Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx 4.1.3 Diffustik / Variant PFTstik 4.1.3.1 Height-Adjustable Arm with Flow Measurement / Shutter System Variant Diffustik Height- adjustable arm Connection sockets (see photo below) Demand valve (see also chap. 6.2.3) Shutter drive with shutter cage (see also chap.

  • Page 43: Height-Adjustable Arm With Flow Measurement / Shutter System Variant Pftstik

    Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx 4.1.3.2 Height-Adjustable Arm with Flow Measurement / Shutter System Variant PFTstik From Prod. 11 / 2018 Height-adjustable arm Lever for height regulation and for moving (see also chap. 7.4)

  • Page 44: Diffustik Device / Connections

    Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx For the Diffustik variant resp. when the "CO Diffusion" option is added to the PFTstik variant, the connection of the relevant components is described in the separate IFU Add-on CO Diffusion.

  • Page 45: Connection On The Height-Adjustable Arm

    Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx For the Diffustik variant resp. when the "CO Diffusion" option is added to the PFTstik variant, the connection of the relevant components is described in the separate IFU Add-on CO Diffusion.

  • Page 46: Sensors

    • The separate IFU Volume Calibration. Flow Sensor The heart of the Diffustik resp. the variant PFTstik for precise flow measurement is the Ergoflow flow sensor. It must be calibrated after every cleaning and before the first examination of a day.

  • Page 47: Pressure Reducer (Optional With Extension „Diffusion Measurement")

    For a complete explanation of the diffusion measurement with the Diffustik variant resp. when the "CO Diffusion" option is added to the PFTstik variant, please refer to the separate IFU Add-on CO Diffusion.

  • Page 48: System Construction And Electrical Safety

    • The technical manual "Formation of Systems". For the Diffustik variant resp. when the "CO Diffusion" option is added to the PFTstik variant, the connection of the relevant components is described in the separate IFU Add-on CO Diffusion.
  • Page 49 Do not install any other software! • Ask your authorised specialist retail partner which devices are approved by the manufacturer! Diffustik resp. the variant PFTstik could be damaged. Reason: Electrostatic discharges. Therefore: • Preferably no floor made of synthetic material! Attention •...

  • Page 50: Equipment Cart With Isolating Transformer

    Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx 4.1.4.1 Equipment Cart with Isolating Transformer The cart, approved by the manufacturer, meets the requirements of the IEC 60601 series of standards and is mandatory to use. You will find more detailed information in: •...

  • Page 51: Technical Protection Measures

    Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx Technical Protection Measures Diffustik resp. the variant PFTstik have 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 specialist retail partner of the manufacturers within the framework of technical monitoring (see also chap.

  • Page 52: Transport Storage And Assembly

    Chap. 11 “Decommissioning / Disposal” • Chap. 15 “Warranty and Service“ The specialist retail partner authorised by the manufacturer is responsible for supplying Diffustik resp. the variant PFTstik to the responsible organisation. Storage Requirements regarding space requirements, media connections and operating conditions can be found in chap. 12 "Technical Specifications".
  • Page 53 Reason: Electric shock. Misdiagnosis caused by measurement error. Therefore: • Prevent improper assembly / installation! • Diffustik resp. the variant PFTstik should only be assembled and installed by officially trained personnel authorised by the manufacturer! For further information see: •...

  • Page 54: Operation

    Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx Operation For the Diffustik variant resp. when the "CO Diffusion" option is added to the PFTstik variant, the safety instructions in the separate IFU Add-on CO Diffusion also apply: Initial Operating The first commissioning of the Diffustik resp.

  • Page 55: Assembly Flow Measuring System

    On / Off switch of the equipment cart! Disconnection of the power supply must be easily accessible! Before the Diffustik resp. the variant PFTstik can be used to perform measurements again, all components must be properly reconnected, the USB connection to the computer must be established, and the Diffustik resp.
  • Page 56 Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx Functional disorders possible. Reason: Components and e.g. plug connections can be damaged. Therefore: Attention • All connections must be made carefully and without too much force! Flow measuring system and shutter...
  • Page 57 Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx 2. a) Connect the shutter block [4a] to the mounting plate from prod. 11/2018 pressing in the dovetail of the shutter block into the appropriate groove [5] of the mounting plate [2].

  • Page 58: Assembly Shutter System

    11 / 2018: Connect shutter plug [7] to shutter block [4a] For the Diffustik variant resp. when the "CO Diffusion" option is added to the PFTstik variant, the connection of the relevant components is described in the separate IFU •...
  • Page 59 If possible, observe the sequence of the work steps, because otherwise it is more difficult to assemble! For the Diffustik variant resp. when the "CO Diffusion" option is added to the PFTstik variant, the connection of the relevant components is described in the separate IFU •...

  • Page 60: Inserting The Flow Sensor

    Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx 6.2.3 Inserting the Flow Sensor 1. Open the closing clap [2] on the flow unit For this: Turn the closure panel [1] on the left and right side Open the closure cap [2] upwards.

  • Page 61: Power Supply And Computer Connection

    The device may only be operated in conjunction with the equipment cart (ergoline ergocar PC) offered by manufacturer! To make the Diffustik resp. the variant PFTstik ready for operation, connect it: 1. USB-connection cable to USB socket of the Diffustik device to free USB port of the computer 2.
  • Page 62 Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx The Diffustik resp. the variant PFTstik is only ready for operation again after a new calibration. See also: • Chap. 7.3 ”Calibrating Diffustik / Variant PFTstik“ • Separate IFU Volume Calibration For the Diffustik variant resp.

  • Page 63: Operating Instructions

    Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx Operating Instructions For the Diffustik variant resp. when the "CO Diffusion" option is added to the PFTstik variant, the work steps in the separate IFU Add-on CO Diffusion also apply: Checking for Worn Parts The Diffustik resp.

  • Page 64: Switching Diffustik / Variant Pftstik On / Off

    Switching Diffustik / Variant PFTstik On / Off When using a cart, this is done via the On / Off switch on the cart. Otherwise the On / Off switch on the back of the Diffustik device must be activated. The Diffustik resp. the variant PFTstik is designed for permanent operation and doesn't need to be switched on and off daily.

  • Page 65: Setting The Height-Adjustable Arm

    Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx Setting the Height-Adjustable Arm Lever [1] for height regulation and [2] to swivel to the side (horizontal) 7.4.1 Height Adjustment 1. Hold the height-adjustable arm 2. Move the lever [1] counterclockwise ...

  • Page 66: Horizontal Adjustment

    (infinitely variable) 3. Move the lever [2] counterclockwise Height-adjustable arm is locked  again 4. Check secure locking Using Diffustik / Variant PFTstik / Performing measurements Descriptions of the individual examinations can be found in the separate IFUs: • Spirometry •...
  • Page 67 • Ask your authorised specialist retail partner! Reason: Electric shock. Device Damage. Therefore: • Do not let any objects fall on the Diffustik resp. the variant PFTstik! • Do not put any objects on the Diffustik resp. the variant PFTstik! •...
  • Page 68 Do not touch shutter drive in case of excessive heat! Diffustik resp. the variant PFTstik could be damaged Reason: Penetrating liquid. Uncleanliness. Therefore: • Do not use any liquids near the Diffustik resp. the variant PFTstik! • Do not expose the Diffustik resp. the variant PFTstik or Attention the entire system to dust or other contamination! Reason: Condensation.

  • Page 69: Exchange Of Disposable Products / Disinfection

    Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx Exchange of Disposable Products / Disinfection 7.6.1 Bacteria- and Virus Filter / Noseclip Possible danger to life. Reason: Cross-contamination. For this: Observe the general medical principles! Therefore: •...

  • Page 70: Servicing / Maintenance

    Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx Servicing / Maintenance For the Diffustik variant resp. when the "CO Diffusion" option is added to the PFTstik variant, the work steps in the separate IFU Add-on CO Diffusion also apply.

  • Page 71: Servicing / Maintenance By The User / Operator

    8.2 “Servicing / Maintenance by the User / Operator”! Servicing / Maintenance by the User / Operator In order to ensure a flawless operation of Diffustik resp. the variant PFTstik over its whole service life, regular servicing and repairs, if applicable, are required.
  • Page 72 If there are any damages, do not operate the system. The damaged parts must be replaced or repaired properly! Reason: Electric shock. Triggering malfunctions of Diffustik resp. the variant PFTstik. Unqualified user / operator can detect sources of failures too late or even cause them. Therefore: •...

  • Page 73: Checking / Exchange Of Tubes And Cables

    Serial no.: xx|8|401|yyy and 2401xxxxx 8.2.1 Checking / Exchange of Tubes and Cables All parts of Diffustik resp. the variant PFTstik should be checked for visible mechanical damage (cracks, tears) each day. If damage is ascertained, the corresponding component must be replaced.
  • Page 74 Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx [1a] Insert with a slight rotation O-Rings Shutter Head [1b] Press firmly [2a] Insert one side into the groove [2b] Slightly screw in [2c] Press the second side into the...

  • Page 75: 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 Diffustik resp. the variant PFTstik functional and clean. Cleaning and disinfection may cause discolouration of the components, but without impairing their function.

  • Page 76: Single Use

    (drift) caused by liquid in the tubes. Therefore: • Clean tubes only externally! • Replace dirty tubes! Diffustik resp. the variant PFTstik could be damaged or fail. Reason: Penetrating liquid into electrical components. Therefore: • Disconnect the Diffustik device before cleaning and disinfecting! •...

  • Page 77: Disinfection

    This applies to the flow unit, Ergoflow, shutter cage and shutter head or shutter block. All parts of the Diffustik resp. the variant PFTstik can be cleaned from dirt with a soft cloth using a cleaning solution / weak soapy water.
  • Page 78 Diffustik resp. the variant PFTstik could be damage. Reason: Improper treated components. Therefore: • For cleaning and disinfection only use those active substances that are approved by the manufacturer (see chap.

  • Page 79: Height-Adjustable Arm

    Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx 9.2.1 Height-Adjustable Arm All parts of the height adjustable arm which come or could come into contact with the patient must be treated with surface disinfection. 9.2.2 Flow Unit 1.

  • Page 80: Ergoflow / Flow Sensor

    Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx 9.2.3 Ergoflow / Flow Sensor Diffustik resp. the variant PFTstik could be damaged. Reason: destruction of the orifice. Therefore: • Do not clean the interior of the sensor, mechanical or with hard water jet! Attention •...

  • Page 81: Shutter System

    Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx 9.2.4 Shutter System 9.2.4.1 Shutter-Cage or Shutter Block 1. Disassemble the shutter system For this: Procced in reverse order as described in chap. 6.2.2 ”Assembly Shutter System“ 2. a) Until product. 11 / 2018:...

  • Page 82: Shutter-Drive

    Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx 9.2.4.2 Shutter-Drive Perform a wipe disinfection For this: Wipe the surface with a wet disinfecting cloth. Page 82 Version: 8 | Release date: 16. August 2021...

  • Page 83: Fault Indication And Repair

    Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx Fault Indication and Repair For the Diffustik variant resp. when the "CO Diffusion" option is added to the PFTstik variant, the notes in the separate IFU • Add-on CO Diffusion also apply.
  • Page 84 (see chap. 6.2.1) the valid range". Checking the connection of the flow unit and the height-adjustable arm (see chap. 4.1.3.3) System restart – Computer and Diffustik resp. the variant PFTstik (see chap. 6.2) Obvious measuring error Checking the last calibration date and recalibrate if necessary (see chap.

  • Page 85: Decommissioning / Disposal

    Decommissioning / Disposal 11.1 Expected Service Life The expected service life of Diffustik resp. the variant PFTstik has been stated by the manufacturer as 8 years. This applies provided the operating conditions, the prescribed servicing intervals, taking into account and complying with all safety information such as is described in this IFU as well as other technical standard regulations are adhered to.

  • Page 86: Infectious / Contaminated Single Use Items

    Serial no.: xx|8|401|yyy and 2401xxxxx In order to ensure environmentally friendly disposal, please contact the authorised specialist retail partner where you purchased Diffustik resp. the variant PFTstik and / or the accessories. 11.3.3 Infectious / Contaminated Single Use Items All contaminated items such as single use flow sensors, filters, mouthpieces and noseclips must be disposed of trough the hospital or medical practice waste.

  • Page 87: Technical Specifications

    Serial no.: xx|8|401|yyy and 2401xxxxx Technical Specifications 12.1 Technical Data For the Diffustik variant resp. when the "CO Diffusion" option is added to the PFTstik variant, the technical specifications described in the separate IFU • Add-on CO Diffusion also apply.
  • Page 88 Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx Flow measurement: Flow sensor: Ergoflow Measuring principle: Differential pressure Measuring range: ±16 l/s Ventilation measuring range: 0 – 300 l/min Flow resistance: < 0.12 kPa / (l/s) < 14 l/s Dead space: <...

  • Page 89: Installation And Operating Conditions

    Installation and Operating Conditions The following conditions supplement chap. 2.2 "Intended Use" and must be observed to maintain the properties of the Diffustik resp. the variant PFTstik guaranteed by the manufacturer and for the safety of the patient and user / operator.

  • Page 90: Electrical Safety Concept

    Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx 12.3 Electrical Safety Concept 12.3.1 Variant Diffustik with Medical Device Cart and Isolation Transformer Page 90 Version: 8 | Release date: 16. August 2021...
  • Page 91 Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx 12.3.2 Variant PFTstik with Medical Device Cart and Isolation Transformer Version: 8 | Release date: 16. August 2021 Page 91...

  • Page 92: Electromagnetic Compatibility / Emc Guidelines

    12.4.1 Emitted Interference Guideline and Manufacturer Declaration Guidelines and manufacturer’s declaration – electromagnetic emissions The Diffustik is determined for operation in an electromagnetic environment as specified below. The user / operator of the Diffustik should ensure that it is operated in this environment. Measurement of Compliance Electromagnetic environment –...

  • Page 93: Interference Resistance For All Me Systems Guideline And Manufacturer Declaration

    Guidelines and manufacturer’s declaration – electromagnetic interference immunity The Diffustik is determined for operation in an electromagnetic environment as specified below. The user / operator of the Diffustik should ensure that it is operated in this environment. Measurement of IEC 60601 – test...

  • Page 94: Interference Resistance For Non-Life-Supporting Me Systems Guideline And Manufacturer Declaration

    Guidelines and manufacturer’s declaration – electromagnetic interference immunity The Diffustik is determined for operation in an electromagnetic environment as specified below. The user / operator of the Diffustik should ensure that it is operated in this environment. Measurement of IEC 60601 -level...
  • Page 95 Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx 7 MHz to 3 MHz 10.1 MHz to 10.15 MHz 14 MHz to 14.2 MHz 18.07 MHz to 18.17 MHz 21.0 MHz to 21.4 MHz 24.89 MHz to 24.99 MHz...
  • Page 96 If the measured field strength at the site where the Diffustik is used exceeds the abovementioned compliance levels, the Diffustik should be observed to demonstrate its intended function.

  • Page 97: Recommended Safety Distances For Non-Life-Supporting Me Systems

    Recommended safety distance between portable and mobile RF communication devices and the Diffustik The Diffustik is determined for operation in an electromagnetic environment in which the RF disturbances are controlled. The user / operator of the Diffustik may help to avoid...

  • Page 98: Safety Of Product And Material

    DIN EN ISO 10993-1:2017- 04 "Biological evaluation of medical devices" (biocompatibility). Diffustik resp. the variant PFTstik is a class IIa 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 99: Product Labeling / Type Label

    Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx Product Labeling / Type Label The Type Label can be found on the bottom of the Diffustik device housing. See: • Chap. 4.1.1 “Overview” point [6]. For more information about the symbols, please read: •...

  • Page 100: Warranty And Service

    Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx 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 101: Packaging And Shipping

    Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx 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 102: Authorised Specialist Retail Partner

    Instructions for Use Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx 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 102 Version: 8 | Release date: 16. August 2021...

  • Page 103: Attachment - Declaration Of Conformity

    Diffustik / Variant PFTstik Serial no.: xx|8|401|yyy and 2401xxxxx Attachment – Declaration of Conformity The Diffustik resp. the variant PFTstik declaration of conformity is enclosed with each device by the manufacturer. Version: 8 | Release date: 16. August 2021 Page 103...

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