Bosch vivatmo pro Instructions For Use Manual
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Bosch vivatmo pro Instructions For Use Manual

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  • Page 1 Instructions for use...

  • Page 2: Table Of Contents

    Before using Vivatmo pro Safety information Intended use/Indications for use System elements ......................9 Screen elements Handheld elements Handheld display Disposable mouthpiece Installation ........................16 Installing the handheld Installing the basestation 3.2.1 User concept 3.2.2 Onboarding Login © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 3 List of measurement orders Settings ........................34 Ambient NO Quality control (QC) 6.2.1 QC Tester qualification 6.2.2 Performing QC System information Administrator settings 6.4.1 Quality Control (QC) setting Maintenance and troubleshooting ................42 Maintenance Instructions for use © Bosch Healthcare Solutions GmbH...
  • Page 4 7.5.2 Troubleshooting handheld Disposal ........................47 Technical data ......................48 Device data Symbols Warranty 10 Manufacturer ......................53 11 Appendix ........................53 11.1 Electromagnetic compatibility 11.2 Compliant cables 11.3 Literature 11.4 License Terms for End Users © Bosch Healthcare Solutions GmbH Instructions for use...

  • Page 5: Initial Information

    You find the twelve digit code on your Vivatmo pro handheld, next to the symbol at the bottom of the device. Bosch privacy statement: This product stores the measurement data and personal information of patients. Instructions for use © Bosch Healthcare Solutions GmbH...

  • Page 6: Safety Information

    • Rooms with open flames, gas range, smoke, or tobacco consumption. • Adjacent or stacked use close to other systems. If adjacent or stacked use is necessary, observe normal operation of the Vivatmo pro. WARNING • Use of mobile phones and other devices even if compliant with CISPR emission requirements.
  • Page 7 • Vivatmo pro shall not be used in unprotected networks or work environments. Data protection is WARNING under the responsibility of the organization using Vivatmo pro and can be supported by the use of credentials on your network. When connecting the basestation to the local area network consider that data is transmitted unencryptedly with the risk of unprotected access to patient data.

  • Page 8: Intended Use/Indications For Use

    Intended use/Indications for use The Bosch Vivatmo pro system is intended for quantitative measurement of fractional nitric oxide (FeNO) in human breath. Measurement of changes in the fractional nitric oxide concentration in expired breath aids in evaluating a patient’s response to anti-inflammatory therapy, as an adjunct to establish clinical and laboratory assessments of inflammatory processes such as asthma.

  • Page 9: System Elements

    System elements System elements Basestation frontside Basestation backside Handheld Ethernet port Charging cradle USB ports On/Off button Power adapter port Touchscreen Instructions for use © Bosch Healthcare Solutions GmbH...

  • Page 10: Screen Elements

    Elements of the basestation homescreen Measurement orders from electronic patient record system Manage patients, measurements and orders Welcome to Vivatmo pro C O N T I N U E C O N T I N U E Charging status handheld battery...
  • Page 11 P A T I E N T R E C O R D Releases measurement result from set of Deletes the current entry. patient data. 1 8 PPB WWWWWWWWWWWWW WWWWWWWWWWWWW 07.04.2016 11:43 Instructions for use © Bosch Healthcare Solutions GmbH WWWWWWWWWWWWW WWWWWWWWWWWWW...

  • Page 12: Handheld Elements

    Warning, the breath intensity is too strong. Procedure correct: Blue blinking. Procedure failed: Red blinking. When the handheld is placed on the basestation blue blinking indicates the charging of the battery. Battery compartment. © Bosch Healthcare Solutions GmbH Instructions for use...

  • Page 13: Handheld Display

    Invalid disposable mouthpiece: Use a new disposable mouth piece Attach disposable mouthpiece Measurement procedure incorrect Measuring ID Time and date of the stored measurement result Device busy Measurement mode Device ready for measurement Instructions for use © Bosch Healthcare Solutions GmbH...
  • Page 14 The battery charge is low. Recharge the handheld device as soon as possible. Battery icon blinking: The battery charge is too low to perform measurements. No battery icon displayed: The battery charge is sufficient. © Bosch Healthcare Solutions GmbH Instructions for use...

  • Page 15: Disposable Mouthpiece

    Level 0 Quality Control (QC) measurement is performed with a specific Level 0 disposable mouthpiece, see “6.2.2 Performing QC”. A comparison measurement is performed for a concentration below 5 ppb. The outside of the Level 0 disposable mouthpiece is white. Instructions for use © Bosch Healthcare Solutions GmbH...

  • Page 16: Installation

    5. Press the ON/OFF button to turn on the handheld. You see all screen icons and the system performs a brief self-test. Then the software version on the handheld is shown. 6. Turn off the device before you replace the battery. © Bosch Healthcare Solutions GmbH Instructions for use...

  • Page 17: Installing The Basestation

    • Do not touch the battery contacts to avoid electrical shortcut. • Dispose of the used battery in compliance with the national or local regulations for battery disposal, see “8 Disposing the Vivatmo pro device and the battery”. Installing the basestation 3.2.1 User concept...

  • Page 18: Onboarding

    1. Connect the jackplug from the power supply unit into the power adapter port on the rear of the Vivatmo pro basestation. 2. Plug the suitable adapter for your country firmly on the power supply unit. 3. Plug the main plug into a suitable socket. The Vivatmo pro basestation starts automatically. © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 19 2. Select the CONTINUE button after the successful addition of an administrator. The User accounts screen opens. You need at least one administrator account to use Vivatmo pro. Remember this access code carefully. The reset of the administrator account can only be done by INFORMATION service personnel. Instructions for use © Bosch Healthcare Solutions GmbH...
  • Page 20 1. Select the CONTINUE button to set up and install the handheld. To assign the handheld press SCAN FOR HANDHELDS. For details, see “5.1.1 Assigning the handheld” in Administration instructions. 2. On the screen, select the FINISH button. The setup procedure is completed. © Bosch Healthcare Solutions GmbH Instructions for use...

  • Page 21: Login

    The Welcome screen opens automatically, when you turn on the basestation. You see the list of all users. Welcome to Vivatmo pro 1. Select your account from the user list. 2. Enter your passcode. Professionals use a 4-digit passcode, administrators an 8-digit passcode.

  • Page 22: Measure

    A mouthpiece can be used for one patient measurement only. In case of an unsuccessful measurement note that 5 attempts are maximal possible with 1 mouthpiece. Use the mouthpiece within 15 minutes after opening its pouch. © Bosch Healthcare Solutions GmbH Instructions for use...

  • Page 23: Measurement Using The Basestation

    Attaching the mouthpiece INFORMATION The Vivatmo pro disposable mouthpiece cleans and stabilizes the breath sample from contaminants to guarantee reliable test results. Use the disposable mouthpiece directly after opening the pouch. Instructions for use © Bosch Healthcare Solutions GmbH...
  • Page 24 60 seconds. According to your selection, the respective visualization is shown. The regeneration may last up to 100 seconds and is needed to guarantee reliable results. To stop INFORMATION the regeneration, remove the mouthpiece from the handheld. © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 25 Before the next FeNO determination, you must remove The measurement was successful. and dispose the mouthpiece, see “8 Disposing the Please remove the mouthpiece. mouthpiece”. 3. Select the x to leave the Result screen. The Patient File screen opens. Instructions for use © Bosch Healthcare Solutions GmbH...
  • Page 26 VISUALIZATION screen and the animation on the screen indicates that the has disappeared. Then press the Enter-button to star t a new regeneration process is ongoing. measurement. The display depends on the selected visualization, INFORMATION see “Visualization and regeneration” in 4.1. © Bosch Healthcare Solutions GmbH Instructions for use...

  • Page 27: Measurement Stand-Alone With The Handheld

    The measurement procedure is guided by the handheld display and the LED on the upper side. Synchronize measurement results of stand-alone measurements with the Vivatmo pro handheld by placing the switched on Vivatmo pro handheld in the cradle of the Vivatmo pro basestation.
  • Page 28 All results are automatically stored on the device. Failed measurement: The LED flashes red and the Exhalation failed icon appears on the display, see “Failed measurement”. 9. Remove the mouthpiece. 10. Discard the mouthpiece, see “8 Disposing the mouthpiece”. © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 29 Press the Arrow left button to show older measured values. • Press the Arrow right button to scroll to the more recent values. Press the Enter button to exit the view. • Instructions for use © Bosch Healthcare Solutions GmbH...

  • Page 30: Manage

    A D D N E W P AT I E N T • Search patients, see “Searching patients”. Joel Linnasalo *1976-09-20 PID 123123123 • Edit patient data, see “Editing patients”. Yue Ying Lung *2001-02-21 PID 123456789 • Delete patient data, see “Deleting patients”. © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 31 DONE. D o n e . ? 1 2 3 4. The gender of the patient can be changed in a drop-down menu. 5. Confirm all entries with SAVE. Instructions for use © Bosch Healthcare Solutions GmbH...
  • Page 32 5. Confirm all entries with SAVE. 2015-06-21 9 PPB 09: 55 Deleting patients 1. In the patient list, select the Delete button. You are asked to confirm before a patient file is deleted. © Bosch Healthcare Solutions GmbH Instructions for use...

  • Page 33: List Of Measurements

    When the measurement is done, the result is send back to the electronic Yue Ying Lung PID 123456789 *2001-02-21 patient record system. Nikola Matějková The patient is added to the list of patients on the Vivatmo pro basestation. PID 123456788 *1987-11-07 Instructions for use © Bosch Healthcare Solutions GmbH...

  • Page 34: Settings

    1. On the Home screen, select the Settings menu. Following options are available: G E N E R A L Welcome to Vivatmo pro, Jouko Kinnunen A M B I E N T N O General Settings to change the brightness of the display.

  • Page 35: Quality Control (Qc)

    For the tester qualification, you have to meet the following criteria: • Over 18 years of age. 1 8 PPB • No ongoing cold or known airway disease. • Non-smoker. • Expected stable FeNO values below 50 ppb. 07.04.2016 11:43 Instructions for use © Bosch Healthcare Solutions GmbH...
  • Page 36 Jeppe M. Gregersendan Qualifiying Administrator 1/3 Passed The QC Tester screen opens and the actual user is highlighted and can Konsta Haapakoski Qualified Professional be selected. Oona Pakarinen-Kattilakoski 2. Select the QUALIFY button. Professional © Bosch Healthcare Solutions GmbH Instructions for use...

  • Page 37: Performing Qc

    In the list, you see all users with their QC status. Your account is highlighted Jeppe M. Gregersendan Qualified Administrator and can be selected. Konsta Haapakoski Qualified Professional If no user management is enabled only the administrator is shown in the list. Oona Pakarinen-Kattilakoski Professional Instructions for use © Bosch Healthcare Solutions GmbH...
  • Page 38 Repeat the measurement and take care to use a new Level 0 mouthpiece. When the Level 0 QC test still fails, contact the service. The measurement was successful. C O N T I N U E © Bosch Healthcare Solutions GmbH Instructions for use...

  • Page 39: System Information

    2. Select Open Source Software to find information and a written offer Software Revision Rev. 2541 concerning open source software components used in the product. Kernel Version 4.4.38 Firmware Version 1.1.25 Open Source Software (OSS) Instructions for use © Bosch Healthcare Solutions GmbH...

  • Page 40: Administrator Settings

    Device settings e.g. language, date and time and Auto-lock • Quality Control (QC) settings, see “6.4.1 Quality Control (QC) setting” • Printer configuration • Vivatmo pro handheld seetings • Network configuration • Order/result interface (HL7 or GDT) • Export and Backup file configuration •...
  • Page 41 The QC Configuration screen opens with an overview of the current QC settings. 10. Check your QC configuration. 11. Confirm with SAVE to save the QC configuration. Find the Administration instructions here: INFORMATION www.vivatmo.com/en/for-doctors/downloads/ Instructions for use © Bosch Healthcare Solutions GmbH...

  • Page 42: Maintenance And Troubleshooting

    Mayr GmbH) or with a soft cloth, moistened with soap cleaning agents. Carefully wipe around openings. 3. For disinfecting repeat step 2 with alcohol disinfectant wipes with maximum 30% alcohol following the wipe’s manufacturer’s instructions for disinfecting. © Bosch Healthcare Solutions GmbH Instructions for use...

  • Page 43: Status Information Handheld

    1. The wrench symbol on the handheld and the basestation indicates that the reconditioning process is on going. The remaining reconditioning time is shown in minutes. 2. The handheld beeps and blinks 3 times blue when reconditioning is finished. 3. Dispose mouthpiece after reconditioning. Instructions for use © Bosch Healthcare Solutions GmbH...

  • Page 44: Remote Software Update

    4. When the Software Update is completed the basestation will restart Rev 2.3.0 improves overall security of this device and solves a touch button bug automatically. Following tests were added: - ABC © Bosch Healthcare Solutions GmbH Instructions for use...

  • Page 45: Troubleshooting

    Charge the handheld on the basestation cradle, see “3.1 Installing the handheld” on page 16. Disposable mouthpiece is not valid. Exchange the mouthpiece and take a new one from the package, see “4.1 Measurement using the basestation”. Instructions for use © Bosch Healthcare Solutions GmbH...
  • Page 46 If the error persists, contact your distribution partner. E‑8 Regeneration failed. Press the ENTER button to repeat the regeneration. If the errors persists, contact your distribution partner. © Bosch Healthcare Solutions GmbH Instructions for use...

  • Page 47: Disposal

    Disposing the mouthpiece The mouthpiece is a single-use product. It contains small quantities of potassium permanganate KMnO4. Use a new mouthpiece for each measurement and dispose the used one in contaminated patient waste. Instructions for use © Bosch Healthcare Solutions GmbH...

  • Page 48: Technical Data

    Electrical safety ME device with external supply, tested according to EN 60601-1, IP20 for basic safety Wireless charging Charging w/ constant current up to 220 mA followed by constant voltage up to 4.2 V stopping when fully charged © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 49 ME device with internal supply, tested according to EN 60601-1, IP20 for basic safety Maximum surface temperature 58°C, touch time < 60 seconds Electromagnetic emissions CISPR 11 Group 1 (battery operated) Electromagnetic immunity IEC 61000-4-2, IEC 61000-4-3 (battery operated), IEC 61000-4-8 Sensor Chemical field-effect transistor Instructions for use © Bosch Healthcare Solutions GmbH...
  • Page 50 Measurement limited to 5 measurement trials within 15 minutes Useful life of disposable mouthpiece Limited by expiration date Vivatmo pro can contain following substances of the actual candidate list of the EU REACH regulation 1907/2006 in a concentration above 0.1%: Lead-monoxide. © Bosch Healthcare Solutions GmbH...

  • Page 51: Symbols

    98/ 79/ EEC IVD Directive Caution, read IFU regarding warnings Keep dry Warning to avoid a hazard Information and advises WARNING INFORMATION IP Protection class Bluetooth compatible Date of expiration Date of manufacture YYYY-MM-DD Instructions for use © Bosch Healthcare Solutions GmbH...

  • Page 52: Warranty

    + A1: 2015 The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Bosch Healthcare Solutions GmbH is under license. Warranty The statutory provisions on warranty rights in consumer goods sales in the country of purchase shall apply.

  • Page 53: Manufacturer

    11.1 Electromagnetic compatibility Important information regarding electromagnetic compatibility (EMC) Hereby, Bosch Healthcare Solutions GmbH, declares that the radio equipment type Vivatmo pro is in compliance with Directive 2014/53/EU. The full text of the EU declaration of conformity is available at the following internet address: https://www.vivatmo.com/en/service-support/additional-information.html...

  • Page 54: Compliant Cables

    The use of accessories, transducers and cables other than those specified may result in increased WARNING emissions or decreased immunity performance of the equipment or system. The following list shows cables, transducers, and other applicable accessories with which Bosch Healthcare Solutions claims EMC compliance. •...

  • Page 55: Literature

    Am J Respir Crit Care Med 2011;184:602-15. 11.4 License Terms for End Users The following License Terms apply to your use of a BOSCH Vivatmo pro device (the “Bosch Product”) wherein Java Programs are embedded, see www. vivatmo. com. Instructions for use...
  • Page 56 OMAN - TRA TA-R/10512/20 D172338 REGISTERED No. ER92285/20 DEALER No. DA97534/20 Complies with IDMA standards DA105282 72413/SPD- DI/2021 10325 72412/SPD- DI/2021 10325 © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 57 Oxycap...
  • Page 58 Bosch Healthcare Solutions GmbH Stuttgarter Straße 130 71332 Waiblingen Germany F09G100238_08 Instructions for use Bosch Healthcare Solutions GmbH Stuttgarter Straße 130 Latest change: 2021-06-11 71332 Waiblingen, Germany...

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