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Bosch Healthcare Solutions GmbH
Stuttgarter Straße 130
71332 Waiblingen
Germany
F09G100512_04
Latest change:
draft
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 F09G100512_04 Bosch Healthcare Solutions GmbH Stuttgarter Straße 130 Latest change: Instructions for use draft 71332 Waiblingen, Germany...
  • Page 2 Oxycap...
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  • Page 4: Table Of Contents

    Before using Safety information Intended use/Indications for use System elements .......................... Screen elements Handheld elements Disposable mouthpiece Handheld display Installation ............................Installing the handheld Installing the basestation 3.2.1 User concept 3.2.2 Onboarding © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 5 Patient records List of measurements 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 Instructions for use © Bosch Healthcare Solutions GmbH...
  • Page 6 6.5.6 Network configuration 6.5.7 Order/result interface 6.5.8 Export and Backup file configuration 6.5.9 Vivasuite configuration User administration Data backup Maintenance and trouble shooting ..................Maintenance Status information handheld Reconditioning Remote Software Update © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 7 Disposing the mouthpiece Technical data ..........................Device data Device Performance Symbols Warranty 10 Manufacturer ..........................11 Appendix ............................11.1 Electromagnetic compatibility 11.2 Compliant cables 11.3 Literature 11.4 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 frequently 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

    Initial information Safety information WARNING The following conditions can cause malfunction or disturbance to the Vivatmo pro and the disposable mouthpiece: • High humidity, extreme temperature (see “9.1 Device data”). • Direct sun radiation or high exposure to dust or volatile substances, e.g., disinfectants or nail polish remover.
  • 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

    Intended use/Indications for use Vivatmo pro Nitric Oxide Test is a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. FeNO is increased in some airway inflammatory processes, such as asthma, and often decreases in response to anti-inflammatory treatment.
  • Page 13: System Elements

    System elements System elements Basestation frontside Basestation backside Handheld Ethernet port Charging cradle USB ports Power adapter port On/Off button 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 P A T I E N T R E C O R D Releases measurement result from set of Prints the current data file. patient data. Delete 1 8 PPB Deletes the current entry. WWWWWWWWWWWWW WWWWWWWWWWWWW 07.04.2016 11:43 WWWWWWWWWWWWW 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 breathe 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

    (parts per billion) 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 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

    Installing the handheld To install the handheld, insert the rechargeable battery. 1. Open the battery compartment on the back of the Vivatmo pro handheld. 2. Hold the handling tab with two fingers and insert the rechargeable battery into the battery compartment. Mind the triangle marks on the battery and inside the battery compartment.
  • Page 21: Installing The Basestation

    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 22: Onboarding

    Avoid connection of the Vivatmo pro basestation to a multiple socket-outlet to prevent interference 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 23 Installation Software setup When you start your Vivatmo pro basestation for the first time, you will be guided through a setup procedure of 5 simple steps, which helps you to enter all the required settings. 1. Switch on the basestation, by pressing the ON/OFF button.
  • Page 24 The User administration screen opens. C O N T I N U E 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 service personnel.
  • Page 25: Login

    0987654321 2. On the 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. Instructions for use...
  • Page 26 The Home screen opens. Select the MEASURE button to start a measurement, see “4 Measure”. • Welcome to Vivatmo pro, Jouko Kinnunen Select the MANAGE button to manage the data, see “5 Manage”. • M E A S U R E...
  • Page 27: Measure

    Measure WARNING If the Vivatmo pro device has been stored in warm and humid environment or not been in use for a longer time, reconditioning may be required and starts automatically during first measurement. Therefore per- form a test measurement every day before using the device with the patient, see “7.3 Reconditioning”.
  • Page 28: Measurement Using The Basestation

    1. Ensure that your handheld is switched on and connected to the basestation (the bluetooth symbol on the handheld finished blinking, the handheld connected icon is shown). Welcome to Vivatmo pro, Jouko Kinnunen 2. On the Home screen, select the MEASURE button. M E A S U R E...
  • Page 29 Measure Attaching the mouthpiece 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. Visualization and regeneration 4. On the VISUALIZATION screen, select the button for the visualization you want to use, either the fish or the scale.
  • Page 30 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. 3. Select the x to leave the Result screen. The Patient File screen opens. © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 31 TION screen and the animation on the screen indicates that the regeneration the Enter-button to star t a new process is ongoing. measurement. The display depends on the selected visualization, see “Visualization and regeneration” in 4.1. Instructions for use © Bosch Healthcare Solutions GmbH...
  • Page 32: 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 33 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”. 8. Remove the mouthpiece. 9. Discard the mouthpiece, see “8.2 Disposing the mouthpiece”. Instructions for use © Bosch Healthcare Solutions GmbH...
  • Page 34 Repeat the measurement, see “4.2 Measurement stand-alone with the handheld”, start at point 4. 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 35: Manage

    Add new patients, see “Adding patients”. Joel Linnasalo • Search patients, see “Searching patients”. *1976-09-20 PID 123123123 Yue Ying Lung • Edit patient data, see “Editing patients”. *2001-02-21 PID 123456789 • Delete patient data, see “Deleting patients”. Instructions for use © Bosch Healthcare Solutions GmbH...
  • Page 36 3. Select the the firstname, lastname and date of birth if required, change content on the selected screen and confirm with DONE. . ? 1 2 3 D o n e 4. The gender of the patient can be changed in a drop-down menu. © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 37 Nikol 2. Enter name or patient-ID. 3. Confirm with DONE. A list opens that shows all patients that correspond to your search criteria. . ? 1 2 3 D o n e Instructions for use © Bosch Healthcare Solutions GmbH...
  • Page 38 8 PPB 2015-10-07 13: 16 9 PPB 2015-06-21 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 39: List Of Measurements

    When the measurement is done, the result is send back to the electronic patient Yue Ying Lung PID 123456789 *2001-02-21 record system. Nikola Matějková PID 123456788 *1987-11-07 The patient is added to the list of patients on the Vivatmo pro basestation. Instructions for use © Bosch Healthcare Solutions GmbH...
  • Page 40: General Settings

    1. On the Home screen, select the Settings menu. G E N E R A L Welcome to Vivatmo pro, Jouko Kinnunen A M B I E N T N O P E R F O R M Q C...
  • Page 41: 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. Instructions for use © Bosch Healthcare Solutions GmbH...
  • Page 42: 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 43: Qc Tester Qualification

    The moving mean value is recalculated when the QC tester performs a new QC-measurement within 7 days. The qualification of a QC tester expires after 30 days. Then the qualification is suspended and the QC tester needs to qualify again, according to the qualification procedure. Instructions for use © Bosch Healthcare Solutions GmbH...
  • Page 44 • Failed: Result is outside acceptance range of the mean of the last 3 measurements. When the qualification procedure is passed, the qualification status of the QC tester is changed to Qualified. The qualified QC tester can perform the defined NO reference measurement test. © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 45: 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 Instructions for use © Bosch Healthcare Solutions GmbH...
  • Page 46 C O N T I N U E QC-measurement QC tester The second reference QC-measurement is performed by a qualified QC tester. For the QC tester qualification procedure, see “6.3.1 QC Tester qualification”. © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 47: 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 Instructions for use © Bosch Healthcare Solutions GmbH...
  • Page 48: 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 © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 49 Date and Time 2. Enter day, month, year and the time. Y Y Y Y 3. Confirm with DONE. 4. Select the CONTINUE button to confirm your settings. D o n e Instructions for use © Bosch Healthcare Solutions GmbH...
  • Page 50 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. © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 51: 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 Instructions for use © Bosch Healthcare Solutions GmbH...
  • Page 52 The QC Configuration screen opens with an overview of the current QC settings. Status Inter val 10. Check your QC configuration. After x measurements Level 0 11. Confirm with SAVE to save the QC configuration. QC Tester S A V E © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 53: 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. Instructions for use © Bosch Healthcare Solutions GmbH...
  • Page 54: 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 Vivasuite Configuration © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 55 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 56: Release The Handheld

    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. © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 57: Network Configuration

    6.5.6 Network configuration 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 Ethernet and Wireless via WLAN connection.
  • Page 58 3. Select the Networktype Ethernet in the drop down menu. DHCP enabled 4. Enable DHCP. D o n e 5. Confirm with SAVE. Network Configuration Networktype Ethernet DHCP enabled S A V E © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 59 8. On the next screen, enter the WLAN Password of your WLAN. 9. Select the Right Arrow or confirm with DONE to leave the screen. WPA2 10. Confirm with SAVE. D o n e Instructions for use © Bosch Healthcare Solutions GmbH...
  • Page 60 5. Enter the IP-Address of your network and the Subnet Mask of your network. Network Configuration 6. Enter the Gateway ID. IP-Address Enter IP … 7. Select the Right arrow or confirm with DONE to leave the screen. D o n e © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 61 4. Follow steps 4 to 8 of “Supported installation of a WLAN connection”. 5. Follow step 5 to 8 of “Manual ethernet configuration”. After a successful configuration, the Network Configuration screen is displayed. 6. Confirm with SAVE. Instructions for use © Bosch Healthcare Solutions GmbH...
  • Page 62: Order/Result Interface

    Settings 6.5.7 Order/result interface Vivatmo pro can receive measurement orders from and send results to an electronic patient record system (EPR), if the network is configured. The interface standards GDT (German Data Transfer) and HL7 are supported. To configure the interface to your patient management system follow the installation wizard: 1.
  • Page 63 Inbox Location smb://example/vivatmo/inbox If you delete the inbox and the outbox, the order button disappears from the Outbox Location home screen. smb://example/vivatmo/outbox Username Praxis-admin-1 Password •••••••••• Communication Test Positive S A V E Instructions for use © Bosch Healthcare Solutions GmbH...
  • Page 64: Export And Backup File Configuration

    4. In accordance to IT definitions in your organization, define the location for the Select Expor t and Backup Drive storage of the export and backup files on USB or network drive. End the location path always with “/”-symbol. Network D o n e © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 65: Vivasuite Configuration

    Vivasuite is the digital Vivatmo ecosystem allowing use of services such as device management and remote software update. Vivasuite runs in the Bosch IoT Cloud and applies highest standards regarding IT security and data privacy. The Vivasuite service is not available in all countries. Ask your local distributor.
  • Page 66 1. Vivatmo pro: On the Network/Interfaces screen, select Vivasuite Vivasuite Configuration Configuration. Language 2. Vivatmo pro: Select Disconnect. You are asked to confirm before device gets Connection Status Connected disconnected. D I S C O N N E C T ©...
  • Page 67: User Administration

    N O T N O W E N A B L E Add new user For adding a new user, follow the configuration wizard: 1. On the User Accounts screen, select the + ADD NEW USER button. Instructions for use © Bosch Healthcare Solutions GmbH...
  • Page 68 4 digit passcode for a professional user. Enter 4-digit Passcode … Passcode • an 8 digit passcode for an administrator account. 5. Repeat the passcode. 6. Confirm with DONE. The user is successfully added. D o n e © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 69 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. Instructions for use © Bosch Healthcare Solutions GmbH...
  • Page 70: Data Backup

    The backup procedures might take up to 5 minutes. Maintenance and trouble shooting Maintenance WARNING Fractures in the housing and ingress of spray, moisture or liquid may cause malfunction to the Vivatmo pro and disposable mouthpiece. © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 71: Status Information Handheld

    Maintenance and trouble shooting 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. 2. Wipe the entire Vivatmo pro with alcohol disinfectant wipes with maximum 30 % alcohol, e.g., Caviwipes1 (Metrex), Mikrobac Tissues (Bode Chemie GmbH) or mikrozid universal...
  • Page 72: Reconditioning

    Reconditioning Vivatmo pro performs an automatic stability check with the first measurement of the day: If the Vivatmo pro device has been stored in a warm and humid environment or has not been in use for a longer time, the wrench symbol may appear on the bases- tation and the handheld.
  • Page 73: Remote Software Update

    Remote Software Update When the Vivatmo pro is connected to Vivasuite (see “6.5.9 Vivasuite configuration”) new software updates will automatically be available on the device. The device administrator always has full control over new software updates. A notification informs about the availablitiy of a new software update and the administrator can perform the software update whenever it fits the schedule.
  • Page 74: Trouble Shooting

    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. © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 75: Trouble Shooting Handheld

    Vivatmo pro handheld, see “7.2 Status information hand- possible. held”. Number of permissible measurement Connect a new Vivatmo pro handheld and dispose of the old trials reached. Device does not perform one, see chapter “8.1 Disposing the Vivatmo pro device and the any measurements after maximum battery”.
  • Page 76 Humidity in device too high. Check ambient conditions and take a new mouthpiece. Ambient temperature and air pressure Use the Vivatmo pro in a location with permissible ambient (altitude) is outside the specified 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 data on your device prior to disposal or service returns ,see “6.5.1 Factory Reset” and “6.5.5 Release the handheld”. 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.
  • 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 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 81: Device Performance

    Linearity Four Vivatmo pro devices were tested as part of the linearity study. Nitric oxide (NO) was mixed in a balance gas of air to obtain NO concentration levels between 8 to 300 ppb. The data showed that the test is linear across this range. The results are listed in the table below.
  • Page 82: Symbols

    In vitro diagnostic medical device 98/79/EEC IVD Directive Caution, read IFU regarding warnings Keep dry Warning to avoid a hazard Information IP Protection class Bluetooth compatible Date of expiration Date of manufacture YYYY-MM-DD © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 83: Warranty

    60601-1-6:2011 + 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 84: Manufacturer

    Développement économique Canada applicables aux appareils radio exempts de licence. L ’exploitation est autorisée aux deux conditions suivantes: (1) l’appareil ne doit pas produire de brouillage, et (2) l’appareil doit accepter tout brouillage radioélectri- que subi, même si le brouillage est susceptible d’en compromettre le fonctionnement. © Bosch Healthcare Solutions GmbH Instructions for use...
  • Page 85 – 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. For manufacturers declaration regarding EMC see www.vivatmo.com.
  • Page 86: Compliant Cables

    Portable RF communication devices (including peripherals such as antenna cables and external antennas) are not to be used closer than 30 cm next to any part of the Vivatmo pro system. The Vivatmo pro is intended for use in professional healthcare facility environment. The customer or the user of Vivatmo pro should assure that it is used in such an environment.
  • Page 87: 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 Runtime Environment are embedded, see www.vivatmo.com. Instructions for use...

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