Bosch vivatmo pro User manual

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

Oxycap

© Bosch Healthcare Solutions GmbH2Instructions for use
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Content
1 Initial information............................................................................................................................6
1.1 Package contents 6
1.2 Before using Vivatmo pro 7
1.3 Safety information 8
1.4 Intended use/Indications for use 10
2 System elements .......................................................................................................................... 11
2.1 Screen elements 12
2.2 Handheld elements 14
2.3 Disposable mouthpiece 15
2.4 Handheld display 16
3 Installation...................................................................................................................................... 18
3.1 User concept 18
3.2 Installing the handheld 19
3.3 Installing the basestation 21
3.4 Login 24

© Bosch Healthcare Solutions GmbH 3Instructions for use
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4 Measure ........................................................................................................................................... 26
4.1 Measurement using the basestation 27
4.2 Measurement stand-alone with the handheld 31
5 Manage............................................................................................................................................. 34
5.1 Patient records 34
5.2 List of measurements 38
5.3 List of measurement orders 38
6 Settings............................................................................................................................................ 39
6.1 General settings 39
6.2 Ambient NO 40
6.3 Quality control (QC) 41
6.3.1 QC Tester qualification 42
6.3.2 Performing QC 44
6.4 System information 46
6.5 Administrator settings 47
6.5.1 Device settings 47
6.5.2 Quality Control (QC) settings 50

© Bosch Healthcare Solutions GmbH4Instructions for use
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6.5.3 Printer configuration 52
6.5.4 Assigning the handheld 53
6.5.5 Network configuration 56
6.5.6 Order/result interface 62
6.5.7 Export file configuration 64
6.6 User administration 65
7 Maintenance and trouble shooting......................................................................................... 69
7.1 Maintenance 69
7.2 Status information handheld 70
7.3 Trouble shooting 70
7.3.1 Wrong or forgotten passcode 70
7.3.2 Trouble shooting handheld 72
8 Disposal ........................................................................................................................................... 75
8.1 Disposing the Vivatmo pro device and the battery 75
8.2 Disposing the mouthpiece 75

© Bosch Healthcare Solutions GmbH 5Instructions for use
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9 Technical data................................................................................................................................ 76
9.1 Device data 76
9.2 Symbols 78
9.3 Warranty 80
10 Manufacturer ................................................................................................................................. 80
11 Appendix ......................................................................................................................................... 81
11.1 Electromagnetic compatibility 81
11.2 Compliant cables 84
11.3 Literature 85
11.4 Oracle License Terms for End Users 85

© Bosch Healthcare Solutions GmbH6 Instructions for use
Initial information
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1 Initial information
1.1 Package contents
• Vivatmo pro basestation
• Handheld device
• 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 7Instructions for use
Initial information
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1.2 Before using Vivatmo pro
Welcome to Vivatmo pro, the measurement system to support a monitoring of respiratory diseases.
Please consider the following before using Vivatmo pro:
• Take enough time to carefully read the instructions for use before using the measurement system. You must understand the
functions, warnings, displays, and operations for a safe and reliable use.
• Inspect the basestation, the handheld, the disposable mouthpiece and the mouthpiece pouch before use. If you notice any
damage do not use the device or accessories.
WARNING
Do not use any defective devices or accessories to avoid malfunction or hazardous situations.
If you need any support or have additional questions including information about data privacy, please contact your distribution
partner or visit the 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.
Bosch privacy statement: This product stores the measurement data and personal information of patients.

© Bosch Healthcare Solutions GmbH8Instructions for use
Initial information
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1.3 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:
• High humidity, extreme temperature („9.1 Device data“ on page 76).
• Direct sun radiation or high exposure to dust or volatile substances, e.g. disinfectants or nail polish
remover.
• Places that are subject to vibration or shock, or near hot surfaces.
• 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.
• Use of mobile phones and other devices even if compliant with CISPR emission requirements.
• Ingress of moisture or liquid.
• Immerse the device or disposable mouthpiece into water or other liquids.
• More than 10 hours nonstop usage with a frequency above 10 measurement trials/hour.
Use the device for a maximum of 10 hours nonstop and allow a break of 10 hours before restarting to
avoid system overload.
When you disconnect the device from the power line, first remove the plug from the wall outlet, then
disconnect the cable from the device to avoid contact to line voltage.

© Bosch Healthcare Solutions GmbH 9Instructions for use
Initial information
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WARNING The assembly of Vivatmo pro and modifications during the actual service life require
evaluation to the requirements of the applied standard. Only connect printers and comput-
ers that comply with IEC/EN 60950-1, IEC 60601-1 or IEC 61010-1 standards, or that bear
the UL or CSA mark. Modifications of the system can lead to endangerments and result in
the warranty becoming invalid.
Data security and protection
• 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.
• Setup, changes and reconfigurations to the network or connected devices is under the
responsibility of the organization using the system and might introduce new risks.
• Delete the personal data on the basestation and handheld device prior to disposal or service
returns.
Bluetooth is activated as long as the basestation is power supplied.

© Bosch Healthcare Solutions GmbH10 Instructions for use
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1.4 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.
The Bosch Vivatmo pro system is a non-invasive measuring device intended to be used in health care environment (in-vitro
diagnostic use) by healthcare professional users only.
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). Patients should be 7 years or older and capable to complete the breathing maneuver.
The measurement procedure of the Vivatmo pro generates the fraction of the exhaled breath (FeNO) based on the
recommendations for the measurement of exhaled respiratory nitric oxide of the European Respiratory Society (ERS) and the
American Thoracic Society (ATS).
FeNO is recommended by the ATS in the diagnosis of eosinophilic airway inflammation and in determining the likelihood of
responsiveness to anti-inflammatory pharmacological therapy in individuals with chronic respiratory symptoms possibly due to
airway inflammation [ATS, 2011].
The Vivatmo pro should only be used as directed in the Vivatmo pro Instruction for Use (IFU). Regardless of displayed measured
results mind signs or symptoms of chest tightness, shortness of breath, coughing or wheezing for decision about treatment.

© Bosch Healthcare Solutions GmbH 11Instructions for use
System elements
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2 System elements
Basestation frontside
1Handheld
2Charging cradle
3On/Off button
4Touchscreen
Basestation backside
1Ethernet port
2USB ports
3Power adapter port
11
4
2 3 2 3

© Bosch Healthcare Solutions GmbH12 Instructions for use
System elements
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2.1 Screen elements
Elements of the basestation homescreen
PATIENTS
AND RESULTS
START NEW
MEASUREMENT
MANAGE
MEASURE
Welcome to Vivatmo pro
3
2
1
6
5
4
1Measurement orders from electronic patient record
system
2Manage patients, measurements and orders
3Charging status handheld battery
4Handheld
4
CONTINUE
connected
4
CONTINUE
disconnected
5Start measurement
6Settings menu/logout
You see the basestation homescreen when you finished the
installation, see „3 Installation“ on page 18.
Screen elements
Element Function Element Function
Help
Opens the Help screen.
4
CONTINUE
Close
Closes the current file.
4
CONTINUE
Arrow left
Moves one screen backward.
4
CONTINUE
Arrow right
Moves one screen forward.

© Bosch Healthcare Solutions GmbH 13Instructions for use
System elements
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Element Function Element Function
4
CONTINUE
Orientation beads
Show the current step during the installation
procedure.
4
CONTINUE
Handheld disconnected
Shows that the handheld is not connected to
the basestation.
4
CONTINUE
View trials
Shows the number of measuring trials.
4
CONTINUE
Handheld connected
Shows that the handheld is connected to the
basestation.
4
CONTINUE
Comment
Adds a comment to the current patient data
file.
4
CONTINUE
Add new user/patient
Opens the screen for the data input of a new
user/patient.
4
CONTINUE
Search
Opens a window for entering search criteria.
4
CONTINUE
Pencil
Opens the current data file for editing.
18PPB
07.04.2016 11:43
PATIENT RECORD
QC !
Quality Control (QC) status
Shows the QC status.
4
CONTINUE
Export
Exports the current data file.
18PPB
NEW MEASUREMENT
07.04.2016 11:43
Joel Linnasalo
* 10.01.2000, m
PID 123123123
WWWWWWWWWWWWW
WWWWWWWWWWWWW
WWWWWWWWWWWWW
WWWWWWWWWWWWW
PATIENT RECORD
Unassign measurement result
Releases measurement result from set of
patient data.
4
CONTINUE
Print
Prints the current data file.
4
CONTINUE
User Administration
Disable access control by user accounts.
4
CONTINUE
Delete
Deletes the current entry.
4
CONTINUE
Enable/Disable user
Enables or disables access for user in user
management.

© Bosch Healthcare Solutions GmbH14 Instructions for use
System elements
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2.2 Handheld elements
On the handheld, you see the following operating elements:
pro
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.
ENTER button: Press this button to start the
regeneration or to confirm selection.
ARROW buttons: Press these buttons to change
the settings and to access stored measuring data.
Breath intensity display:
Feedback during the measurement
Yellow: Caution, the breath intensity is too weak.
Blue: The breath intensity is right.
Red: Warning, the breath intensity is too strong.
Procedure correct: Blue blinking.
Procedure failed: Red blinking.
Charging mode:
When the handheld is placed on the basestation blue
blinking indicates the charging of the battery.
Battery compartment

© Bosch Healthcare Solutions GmbH 15Instructions for use
System elements
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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.
2.3 Disposable mouthpiece
To perform a measurement with the Vivatmo pro system a disposable mouthpiece is needed.
Regular disposable mouthpiece (Oxycap)
The regular Vivatmo pro disposable mouthpiece must be attached for performing
all measurements (except of QC Level 0 measurements as described below).
The outside of the regular disposable mouthpiece is transparent.
The disposable mouthpiece chemically prepares the test sample. Human breath is
cleaned from contaminants and stabilized to guarantee reliable test results.
QC Level 0 disposable mouthpiece
Level 0 Quality Control (QC) measurement is performed with a specific Level 0
disposable mouthpiece, see „6.3.2 Performing QC“ on page 44. A comparison
measurement is performed for a concentration below 5 ppb. The outside of the
Level 0 disposable mouthpiece is white.

© Bosch Healthcare Solutions GmbH16 Instructions for use
System elements
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2.4 Handheld display
1
9
1011
12
14
2
3
4
5
6
7
13
8
1Measured value
2Concentration of nitric oxide (NO) in exhaled breath in
ppb (parts per billion)
3Invalid disposable mouthpiece: Use a new disposable
mouth piece
4Attach disposable mouthpiece
5Measurement procedure incorrect
6Measuring ID
7Delete all settings
8Status rechargeable battery
9Device busy
10
Audio sound activated/deactivated
11
Bluetooth connection activated/deactivated
12
Ambient NO measurement
13
Time and date of the stored measurement result
14
Device ready for measurement

© Bosch Healthcare Solutions GmbH 17Instructions for use
System elements
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Handheld symbols
Icon Function
Concentration of NO in exhaled breath in parts per billion.
Permissible number of measurement trials reached soon.
Disposable mouthpiece is not valid.
Regeneration in progress.
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.
Battery icon displayed: 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 GmbH18 Instructions for use
Installation
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3 Installation
Before you start using your Vivatmo pro perform the following steps:
• Install the handheld.
• Install the basestation.
3.1 User concept
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.
Vivatmo pro supports 2 levels of user access:
Professionals can:
• Perform measurements, see „4. Measure“ on page 26.
• Manage patient data and measurement orders, see „5. Manage“ on page 34.
• Change display, see „Setting the display“ on page 39.
• Perform Ambient NO measurement, see „6.2 Ambient NO“ on page 40.
• Perform QC-measurement, see „6.3.2 Performing QC“ on page 44.
• Export and print.