Bosch vivatmo pro User manual

Bosch Healthcare Solutions GmbH
Stuttgarter Straße 130
71332 Waiblingen, Germany
Bosch Healthcare Solutions GmbH
Stuttgarter Straße 130
71332 Waiblingen
Germany
F09G100512_04
Latest change:
draft Instructions for use

Oxycap

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© 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 Installing the handheld 18
3.2 Installing the basestation 19
3.2.1 User concept 19
3.2.2 Onboarding 20

© Bosch Healthcare Solutions GmbH 3Instructions for use
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3.3 Login 23
4 Measure ........................................................................................................................................... 25
4.1 Measurement using the basestation 26
4.2 Measurement stand-alone with the handheld 30
5 Manage............................................................................................................................................. 33
5.1 Patient records 33
5.2 List of measurements 37
5.3 List of measurement orders 37
6 Settings............................................................................................................................................ 38
6.1 General settings 38
6.2 Ambient NO 39
6.3 Quality control (QC) 40
6.3.1 QC Tester qualification 41
6.3.2 Performing QC 43
6.4 System information 45
6.5 Administrator settings 46
6.5.1 Device settings 46

© Bosch Healthcare Solutions GmbH4Instructions for use
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6.5.2 Quality Control (QC) settings 49
6.5.3 Printer configuration 51
6.5.4 Assigning the handheld 52
6.5.5 Release the handheld 54
6.5.6 Network configuration 55
6.5.7 Order/result interface 60
6.5.8 Export and Backup file configuration 62
6.5.9 Vivasuite configuration 63
6.6 User administration 65
6.7 Data backup 68
7 Maintenance and trouble shooting......................................................................................... 68
7.1 Maintenance 68
7.2 Status information handheld 69
7.3 Reconditioning 70
7.4 Remote Software Update 71

© Bosch Healthcare Solutions GmbH 5Instructions for use
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7.5 Trouble shooting 72
7.5.1 Wrong or forgotten passcode 72
7.5.2 Trouble shooting handheld 73
8 Disposal ........................................................................................................................................... 75
8.1 Disposing the Vivatmo pro device and the battery 75
8.2 Disposing the mouthpiece 75
9 Technical data................................................................................................................................ 76
9.1 Device data 76
9.2 Device Performance 79
9.3 Symbols 80
9.4 Warranty 81
10 Manufacturer ................................................................................................................................. 82
11 Appendix ......................................................................................................................................... 82
11.1 Electromagnetic compatibility 82
11.2 Compliant cables 84
11.3 Literature 84
11.4 License Terms for End Users 85

© Bosch Healthcare Solutions GmbH6Instructions 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 frequently 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 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 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.
• 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. Changes or modifications made to
this equipment not expressly approved by Bosch Healthcare Solutions may void the FCC
authorization to operate this equipment. Only connect printers and computers that comply
with EN 60950-1, EN 60601-1 or EN 61010-1 standards, or that bear the UL or CSA mark.
Connect ethernet port only to networks with galvanic isolation certified to EN 60601-1 or
use an external network isolator certified to EN 60601-1. 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 personal data on the basestation and handheld prior to disposal or service returns.
Bluetooth is activated as long as the basestation is power supplied.

© Bosch Healthcare Solutions GmbH10 Instructions for use
Initial information
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1.4 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. Measurement of FeNO by Vivatmo pro is a method to measure the decrease in FeNO concentration in asthma patients
that often occurs after treatment with anti- inflammatory pharmacological therapy as an indication of therapeutic effect in pa-
tients with elevated FeNO levels. FeNO measurements are to be used as an adjunct to established clinical assessments.
Vivatmo pro is suitable for children, approximately 7-17 years, and adults 18 years and older.
Testing using the Vivatmo pro should only be done in a point- of-care healthcare setting under professional supervision. Vivatmo
pro should not be used in critical care, emergency care or in anesthesiology.

© 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 the installation is
complete, see “3 Installation”.
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
Shows the current step during the
installation procedure.
4
CONTINUE
User Administration
Disable access control by user accounts.
4
CONTINUE
View trials / Reconditioning active
Shows the number of measuring trials.
4
CONTINUE
Enable/Disable user
Enables or disables access for user in user
management.
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
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
QC
Unassign measurement result
Releases measurement result from set of
patient data.
4
CONTINUE
Print
Prints the current data file.
4
CONTINUE
Delete
Deletes the current entry.

© 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 breathe 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.
When the handheld is placed on the basestation blue
blinking light indicates that battery is charging.
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”. 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
2
3
4
5
6
7
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
7Time and date of the stored measurement result
8Device busy
9Device ready for measurement

© Bosch Healthcare Solutions GmbH 17Instructions for use
System elements
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Handheld symbols
Icon Function
Reconditioning active.
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 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.
3. Apply the battery cover.
4. Remove protective cap and place the handheld on the basestation cradle
for charging. Charge before first use. The recharging time for a
completely exhausted battery is about 12 hours. As long as the LED is
blinking blue, the handheld is charging.
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.