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

Bosch vivatmo pro Instructions For Use Manual

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Bosch Healthcare Solutions GmbH
Stuttgarter Straße 130
71332 Waiblingen
Germany
F09G100238_02
Latest change: 2018-11-12
Bosch Healthcare Solutions GmbH
Stuttgarter Straße 130
71332 Waiblingen, Germany
Instructions for use
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  • Page 1 Bosch Healthcare Solutions GmbH Stuttgarter Straße 130 71332 Waiblingen Germany Bosch Healthcare Solutions GmbH F09G100238_02 Stuttgarter Straße 130 Instructions for use Latest change: 2018-11-12 71332 Waiblingen, Germany...
  • Page 2 Oxycap...

  • Page 4: Table Of Contents

    Content Initial information ..........................Package contents Before using Vivatmo pro Safety information Intended use/Indications for use System elements .......................... Screen elements Handheld elements Disposable mouthpiece Handheld display Installation ............................User concept Installing the handheld Installing the basestation Login © Bosch Healthcare Solutions GmbH...
  • Page 5 List of measurement orders Settings ............................General settings Ambient NO Quality control (QC) 6.3.1 QC Tester qualification 6.3.2 Performing QC System information Administrator settings 6.5.1 Device settings 6.5.2 Quality Control (QC) settings Instructions for use © Bosch Healthcare Solutions GmbH...
  • Page 6 Maintenance and trouble shooting ..................Maintenance Status information handheld Trouble shooting 7.3.1 Wrong or forgotten passcode 7.3.2 Trouble shooting handheld Disposal ............................Disposing the Vivatmo pro device and the battery Disposing the mouthpiece © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 7 Technical data ..........................Device data Symbols Warranty 10 Manufacturer ..........................11 Appendix ............................11.1 Electromagnetic compatibility 11.2 Compliant cables 11.3 Literature 11.4 Oracle License Terms for End Users Instructions for use © Bosch Healthcare Solutions GmbH...

  • Page 8: Initial Information

    Instructions for use • Power supply unit with connectors • 1 rechargeable lithium-ion battery Keep these Instructions for use for future reference. For frequent used functions see chapter 3, 4, 5, 7 and 8. © Bosch Healthcare Solutions GmbH Instructions for use...

  • Page 9: Before Using Vivatmo Pro

    Bosch Vivatmo website at www.vivatmo.com. Have your serial number of your handheld or your basestation available when you contact the service center. You find the twelve digit code on your Vivatmo pro handheld, next to the symbol at the bottom of the device.

  • Page 10: Safety Information

    Safety information WARNING When using the Vivatmo pro handheld for the first time discard the first 10 measurement results to exclude impact from the initial device setup. The following conditions can cause malfunction or disturbance to the Vivatmo pro and the disposable mouthpiece: •...
  • Page 11 • Vivatmo pro shall not be used in unprotected networks or work environments. Data protection is 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 12: Intended Use/Indications For Use

    The results of the Vivatmo pro should not be used as a sole parameter for the diagnosis or screening of airway diseases. The Vivatmo pro measurement procedure requires patients’ cooperation by breathing into the device via a disposable mouthpiece (Oxycap).

  • Page 13: System Elements

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

  • Page 14: Screen Elements

    Measurement orders from electronic patient record system Manage patients, measurements and orders C O N T I N U E Welcome to Vivatmo pro C O N T I N U E Charging status handheld battery Handheld M E A S U R E...
  • Page 15 User Administration Delete 1 8 PPB Disable access control by user accounts. Deletes the current entry. WWWWWWWWWWWWW WWWWWWWWWWWWW Enable/Disable user 07.04.2016 11:43 WWWWWWWWWWWWW Enables or disables access for user in user management. WWWWWWWWWWWWW Instructions for use © Bosch Healthcare Solutions GmbH...

  • Page 16: Handheld Elements

    System elements Handheld elements On the handheld, you see the following operating elements: Disposable mouthpiece: Interface to breath into the Vivatmo pro handheld. Display: Shows current and stored measuring data and device messages. ON/OFF button: Activate and deactivate the device.

  • Page 17: Disposable Mouthpiece

    The measurement procedure is guided by an animation on the display of the basestation or the LED on the back of the handheld. 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 18: Handheld Display

    Measurement procedure incorrect Measuring ID Delete all settings Status rechargeable battery Device busy Audio sound activated/deactivated Bluetooth connection activated/deactivated Ambient NO measurement Time and date of the stored measurement result Device ready for measurement © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 19 Ambient NO measurement in progress. The memory is cleared. The Vivatmo pro handheld is connected to the Vivatmo pro basestation. The icon disappears when the Vivatmo pro handheld is used as a stand-alone device without the Vivatmo pro basestation. The audio sound is activated. The icon appears when audio sound is activated.

  • Page 20: Installation

    User accounts protect your patient data by access control to the system. When the user management is activated, the access is protected by the user name and a numeric passcode. You can use Vivatmo pro also when the user management is deactivated.

  • Page 21: Installing The Handheld

    Install printers and export locations, see „6.5.3 Printer configuration“ on page 52 and „6.5.7 Export file configuration“ on page 64. • Change Vivatmo pro handheld used with the basestation, see „6.5.4 Assigning the handheld“ on page 53. • Configure network, see „6.5.5 Network configuration“ on page 56.
  • Page 22 • Remove the battery if you are not using the device for a prolonged period of time. • Dispose of the used battery in compliance with the national or local regulations for battery disposal, see „8.1 Disposing the Vivatmo pro device and the battery“ on page 75. © Bosch Healthcare Solutions GmbH...

  • Page 23: Installing The Basestation

    Avoid to connect the Vivatmo pro basestation to a multiple socket-outlet to prevent interferences by other devices. 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.
  • Page 24 As administrator you can add or edit user 2. Select the CONTINUE button after the successful addition of an administrator. accounts and change system settings. The User administration screen opens. C O N T I N U E © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 25 The NOT NOW button skips the creation of additional user accounts. You can activate or deactivate user accounts within the settings as well. Using the Vivatmo pro without the user management is only recommended when you do not use patient records. When you select the NOT NOW button, the user identifi cation will be deactivated.

  • Page 26: Login

    2. On the success screen, select the FINISH button.The setup procedure is completed. Login When user accounts are enabled, Vivatmo pro demands authentication on the system. You have to login before you can start using the system. The Welcome screen opens automatically, when you turn on the basestation. You see the list of all users.
  • Page 27 F O R G O T The Home screen opens. Select the MEASURE button to start a measurement, see „4 Measure“ on • Welcome to Vivatmo pro, Jouko Kinnunen page 26. Select the MANAGE button to manage the data, see „5 Manage“ on •...

  • Page 28: Measure

    Measure WARNING When using the Vivatmo pro handheld for the first time or after a storage period of more than 2 weeks neglect the first 10 measurements result to exclude environmental impact. Environmental impact can be excluded by at least 3 measurements with included regeneration per week.

  • Page 29: Measurement Using The Basestation

    The following chapters describe how to perform the measurement with the basestation. 1. Check if the Vivatmo pro handheld is switched on and the bluetooth symbol on the handheld fi nished blinking. The handheld connected icon on the display is closed then.
  • Page 30 The regeneration lasts up to 100 seconds. During this time, a circular animation on the screen indicates that the regenera- tion process is working. Stop the regeneration if required by detaching the disposable mouthpiece from the handheld. © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 31 60 seconds. Before the next FeNO determination, you must remove and The measurement was successful. dispose the mouthpiece, see „8.2 Disposing the mouthpiece“ Please remove the mouthpiece. on page 75. Instructions for use © Bosch Healthcare Solutions GmbH...
  • Page 32 Enter-button to star t a new ongoing. measurement. The display depends on the selected visualization, see „Visualization and regeneration“ on page 28. © Bosch Healthcare Solutions GmbH Instructions for use...

  • Page 33: 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 34 Failed measurement: The LED fl ashes red and the Exhalation failed icon appears on the display, see „Failed measurement“ on page 30. 8. Remove the mouthpiece. 9. Discard the mouthpiece, see „8.2 Disposing the mouthpiece“ on page 75. © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 35 Repeat the measurement, see „4.2 Measurement stand-alone with the handheld“ on page 31, start at point 3. Displaying stored measured values Your Vivatmo pro handheld automatically stores up to 1,000 measured FeNO values, identified by time, date and measuring ID. The measured values are stored in descending order starting with the latest.

  • Page 36: Manage

    Search patients, see „Searching patients“ on page 36. *1976-09-20 PID 123123123 Yue Ying Lung • Edit patient data, see „Editing patients“ on page 37. *2001-02-21 PID 123456789 • Delete patient data, see „Deleting patients“ on page 37. © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 37 3. Select the the fi rstname, lastname and date of birth if required, change content on the selected screen and confi rm with DONE. 4. The gender of the patient can be change in a drop-down menue. . ? 1 2 3 D o n e Instructions for use © Bosch Healthcare Solutions GmbH...
  • Page 38 2. Enter name or patient-ID. 3. Confi rm with DONE. A list opens that shows all patients that correspond to your search criteria. . ? 1 2 3 D o n e © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 39 8 PPB 13: 16 2015-06-21 09: 55 9 PPB Deleting patients 1. In the patient list, select the Delete button. You are asked to confi rm before a patient fi le is deleted. Instructions for use © Bosch Healthcare Solutions GmbH...

  • Page 40: List Of Measurements

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

  • Page 41: General Settings

    The access to settings depends on the login as professional or administrator, see „3.1 User concept“ on page 18. 1. On the Home screen, select the Settings menu. G E N E R A L Welcome to Vivatmo pro, Jouko Kinnunen Welcome to Vivatmo pro, Jouko Kinnunen...

  • Page 42: Ambient No

    When the ambient NO measurement is done, you see the result on the screen. Ambient Measurement last measurement : 2018-03-12 - 07:02 18 PPB The measurement was successful. Please remove the mouthpiece. © Bosch Healthcare Solutions GmbH Instructions for use...

  • Page 43: Quality Control (Qc)

    Quality control (QC) External QC tests are used to control the measurements of the Vivatmo pro handheld in comparison to reference concentrations of nitric oxide (NO). The system documents the tester who performs the QC tests by the user login.

  • Page 44: Qc Tester Qualification

    The QC-measurement on the fourth day must be within ± 10 ppb from the mean value. The moving mean value is recalculated when the QC tester performs a new QC-measurement within 7 days. © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 45 When the qualifi cation procedure is passed, the qualifi cation status of the QC tester is changed to Qualifi ed. The qualifi ed QC tester can perform the defi ned NO reference measurement test. Instructions for use © Bosch Healthcare Solutions GmbH...

  • Page 46: Performing Qc

    In the list, you see all users with their QC status. Your account is highlighted and Administrator 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 © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 47 C O N T I N U E QC-measurement QC tester The second reference QC-measurement is performed by a qualifi ed QC tester. For the QC tester qualifi cation procedure, see „6.3.1 QC Tester qualifi cation“ on page 42. Instructions for use © Bosch Healthcare Solutions GmbH...

  • Page 48: System Information

    2. Select Open Source Software to fi nd information and a written off er 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 © Bosch Healthcare Solutions GmbH Instructions for use...

  • Page 49: Administrator Settings

    The Device Settings screen opens for changing Language, Date and Time, Language Auto-Lock or Factory Reset. Factory Reset resets all stored data and settings. Language Date and Time Auto-Lock Factor y Reset Instructions for use © Bosch Healthcare Solutions GmbH...
  • Page 50 Date and Time 2. Enter day, month, year and the time. Y Y Y Y 3. Confi rm with DONE. 4. Select the CONTINUE button to confi rm your settings. D o n e © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 51 Factory reset removes all stored measurements from the basestation and all data of patients and users. Date and time are reset and no handheld will be connected afterwards. Use factory reset prior to disposal or service returns only. Instructions for use © Bosch Healthcare Solutions GmbH...

  • Page 52: Quality Control (Qc) Settings

    • by time: select daily, weekly, bi-weekly or Select Inter val by number of performed measurements: select After x measurements. • Daily Select the Arrow Right button. Weekly Bi-Weekly After x measurements © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 53 QC settings. Status 10. Check your QC confi guration. Inter val After x measurements Level 0 11. Confi rm with SAVE to save the QC confi guration. QC Tester S A V E Instructions for use © Bosch Healthcare Solutions GmbH...

  • Page 54: Printer Configuration

    4. On the Select Printer screen, select the desired printer. HP 550 PCS 5. Select the Right Arrow to move to the Select Printer Driver screen. D o n e 6. Select the printer driver. © Bosch Healthcare Solutions GmbH Instructions for use...

  • Page 55: Assigning The Handheld

    2. Select the Delete button to delete a printer from the list. 3. Select the x button to close the list. 6.5.4 Assigning the handheld 1. On the Administration screen, select Network/Interfaces. Network/Interfaces Language Assign Handheld Network Order/Result Interface Export Location Instructions for use © Bosch Healthcare Solutions GmbH...
  • Page 56 You see the list of active handhelds. If no handheld is active, you see the message: “No handhelds available”. 6. Compare the number of the Vivatmo pro handheld in the list with the serial number beneath the symbol on the handle of the handheld.
  • Page 57 3. Press the ENTER button to confirm the clear memory. An animation is shown while the Clear memory icon flashes. 4. Press the ENTER button to return to the main screen. 5. Switch off the handheld. Instructions for use © Bosch Healthcare Solutions GmbH...

  • Page 58: Network Configuration

    6.5.5 Network confi guration Vivatmo pro can be connected to a local area network to receive measurement orders, send back measurement results, export patient related measurement data, or use a network printer. Vivatmo pro supports 2 types of network connections: •...
  • Page 59 Select Networksetup 2. On the Network screen, select Confi gure Network. Networktype Ethernet 3. Select the Networktype Ethernet in the drop down menue. DHCP enabled 4. Enable DHCP. D o n e Instructions for use © Bosch Healthcare Solutions GmbH...
  • Page 60 4. On the Set network SSID screen, enter the name of the WLAN. 5. Select the Right Arrow or the DONE button to leave the screen. . ? 1 2 3 D o n e © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 61 Manual ethernet confi guration 1. Plug in the ethernet cable in the ethernet port of the basestation. Network 2. On the Network screen, select Confi gure Network. Language Configure Network Show Network Configuration Instructions for use © Bosch Healthcare Solutions GmbH...
  • Page 62 6. Enter the Subnet Mask of your network. Network Configuration 7. Enter the Gateway ID. Subnet Mask Enter Subnet Mask … 8. Select the Right arrow or confi rm with DONE to leave the screen. D o n e © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 63 4. Follow steps 4 to 8 of „Supported installation of a WLAN connection“ on page 58. 5. Follow step 5 to 8 of „Manual ethernet confi guration“ on page 59. After a successful confi guration, the Network Confi guration screen is displayed. 6. Confi rm with SAVE. Instructions for use © Bosch Healthcare Solutions GmbH...

  • Page 64: Order/Result Interface

    Settings 6.5.6 Order/result interface Vivatmo pro can receive measurement orders from and send results to an electronic patient record system (EPR) , if the network is confi gured. The interface standards GDT (German Data Transfer) and HL7 are supported. To confi gure the interface to your patient management system follow the installation wizzard using the Arrows and the DONE buttons: 1.
  • Page 65 Inbox Location smb://example/vivatmo/inbox Outbox Location smb://example/vivatmo/outbox If you delete the inbox and the outbox, the order button disappears from the home screen. Username Praxis-admin-1 Password •••••••••• Communication Test Positive S A V E Instructions for use © Bosch Healthcare Solutions GmbH...

  • Page 66: Export File Configuration

    6.5.7 Export fi le confi guration When your Vivatmo pro is connected to a network, you can export data from patient records and from the list of measurements. Export fi les of a patient can be identifi ed by the time stamp and the patient name. Measurements are exported with time stamp too.

  • Page 67: User Administration

    Access control by user accounts can be disabled by the button Language Language Language Language A D D N E W U S E R Jeppe M. Gregersendan Administrator Konsta Haapakoski Professional Oona Pakarinen-Kattilakoski Professional Instructions for use © Bosch Healthcare Solutions GmbH...
  • Page 68 1. On the User Accounts screen, select the ADD NEW USER button. 2. Select the desired user type, see „3.1 User concept“ on page 18. New User Account • Administrator Select User type • Professional Administrator Professional D o n e © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 69 1. On the User Accounts screen, select the user you want to edit. 2. Select the Pencil button. 3. Enter your changes to user name and passcode. 4. Confi rm with DONE. Instructions for use © Bosch Healthcare Solutions GmbH...
  • Page 70 When lock is open, the user access is enabled. Deleting user accounts 1. On the User Accounts screen, select the user you want to delete. 2. Select the Delete button. The account is deleted. © Bosch Healthcare Solutions GmbH Instructions for use...

  • Page 71: Maintenance And Trouble Shooting

    • Fractures in the housing. • Ingress of spray, moisture or liquid. The Vivatmo pro is easy to maintain. Clean the device in accordance with the hygienic standards of your organization. Cleaning and Disinfecting 1. Turn off the device. Wash hands thoroughly with soap and water.

  • Page 72: Status Information Handheld

    Maintenance and trouble shooting Status information handheld C O N T I N U E The number of measurement trials you can perform with one Vivatmo pro handheld is limited. Your handheld 234094758 1. Slide up the handheld connected icon to view the number of trials left.
  • Page 73 C O N T I N U E The system needs at least 1 administrator login. If the administrator passcode is forgotten, Vivatmo pro needs to be reset by a service technician. Instructions for use © Bosch Healthcare Solutions GmbH...

  • Page 74: Trouble Shooting Handheld

    31. time-limit after regeneration was exceeded. Permissible number of measurements See display for number of remaining measurements. Order new reached soon, measurements still Vivatmo pro handheld. possible. © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 75 Display Description Solution Number of permissible measurements Connect a new Vivatmo pro handheld and dispose the old one, reached. Device does not perform any see chapter „8.1 Disposing the Vivatmo pro device and the measurements after maximum number battery“ on page 75.
  • Page 76 Display Description Solution Ambient temperature and air pressure Use the Vivatmo pro in location with permissible ambient (altitude) is outside the specifi ed range. conditions. When transporting the device from one place to another, a stabilization period of at least 20 minutes should be observed before use.

  • Page 77: Disposal

    Disposal Disposal Disposing the Vivatmo pro device and the battery Delete the data on your device prior to disposal or service returns. For the purpose of disposal, please separate this device from other waste to prevent possible harm to the environment or human health from uncontrolled waste disposal. Turn in the device for recycling in order to promote the sustainable reuse of material resources (in compliance with EU directive 2012/19/EU).

  • Page 78: Technical Data

    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 79 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) Instructions for use © Bosch Healthcare Solutions GmbH...

  • Page 80: Symbols

    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. Symbols...
  • Page 81 Electrical safety class II 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. Instructions for use © Bosch Healthcare Solutions GmbH...

  • Page 82: Warranty

    The statutory provisions on warranty rights in consumer goods sales in the country of purchase shall apply. 10 Manufacturer Bosch Healthcare Solutions GmbH Stuttgarter Str. 130 71332 Waiblingen, Germany E-Mail:[email protected] Internet: www.vivatmo.com © Bosch Healthcare Solutions GmbH Instructions for use...

  • Page 83: Appendix

    – electromagnetic emissions EN60601-1-2:2015 both in terms of immunity and of emissions and does therefore not need any service and maintenance regarding EMC and ESD over lifetime. Vivatmo pro basestations with a date of manufacture before 1st November 2018 comply with EN 61326-1:2013 for EMC.
  • Page 84 Electromagnetic environment – guidance RF emissions CISPR 11 Group 1 The Vivatmo pro uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
  • Page 85 Pulse modulation 217 Hz* 1970 2450 Pulse modulation 217 Hz* 5240 5500 Pulse modulation 217 Hz* 5785 Supplementary information: * the carrier shall be modulated using a 50% duty cycle square wave signal Instructions for use © Bosch Healthcare Solutions GmbH...

  • Page 86: Compliant Cables

    Medical devices may be affected by cellular telephones and other personal or household devices not intended for medical facilities. It is recommended that all equipment used near the Vivatmo pro device comply with the medical electromagnetic compatibility standard and to check before use that no interference is evident or possible. If interference is suspected or possible, switching off the offending device is the normal solution, as is required in aircraft and medical facilities.

  • Page 87: Literature

    11.4 Oracle License Terms for End Users The following Oracle License Terms apply to your use of a BOSCH Vivatmo Pro device (the “Bosch Product”) wherein Java Programs 1. Definitions:“Java Program” refers to (a) Oracle Java SE Embedded, a Java™ software product in binary code form owned by Oracle Americas, Inc.
  • Page 88 Programs (the foregoing prohibition includes but is not limited to review of data structures or similar materials produced by Java Programs); d. install or permit third parties to install the Java Programs separately and independently from the Bosch Product you licensed or acquired.

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