Bosch vivatmo pro User manual

Instructions for use

© Bosch Healthcare Solutions GmbH2Instructions for use
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Content
1 Initial information.......................................................................................................5
1.1 Before using Vivatmopro 5
1.2 Safety information 6
1.3 Intended use/Indications for use 8
2 System elements ........................................................................................................9
2.1 Screen elements 10
2.2 Handheld elements 12
2.3 Handheld display 13
2.4 Disposable mouthpiece 15
3 Installation................................................................................................................16
3.1 Installing the handheld 16
3.2 Installing the basestation 17
3.2.1 User concept 17
3.2.2 Onboarding 18
3.3 Login 21

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4 Measure ....................................................................................................................22
4.1 Measurement using the basestation 23
4.2 Measurement stand-alone with the handheld 27
5 Manage .....................................................................................................................30
5.1 Patient records 30
5.2 List of measurements 33
5.3 List of measurement orders 33
6 Settings.....................................................................................................................34
6.1 Ambient NO 34
6.2 Quality control (QC) 35
6.2.1 QC Tester qualification 35
6.2.2 Performing QC 37
6.3 System information 39
6.4 Administrator settings 40
6.4.1 Quality Control (QC) setting 40
7 Maintenance and troubleshooting ...........................................................................42
7.1 Maintenance 42

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7.2 Status information handheld 43
7.3 Reconditioning 43
7.4 Remote Software Update 44
7.5 Troubleshooting 45
7.5.1 Wrong or forgotten passcode 45
7.5.2 Troubleshooting handheld 45
8 Disposal ....................................................................................................................47
9 Technical data...........................................................................................................48
9.1 Device data 48
9.2 Symbols 51
9.3 Warranty 52
10 Manufacturer ............................................................................................................53
11 Appendix...................................................................................................................53
11.1 Electromagnetic compatibility 53
11.2 Compliant cables 54
11.3 Literature 55
11.4 License Terms for End Users 55

© Bosch Healthcare Solutions GmbH 5Instructions for use
Initial information
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1 Initial information
INFORMATION
Keep these Instructions for use for future reference. For frequent used functions see chapter3, 4,
5,7 and8. For Administration instructions see specific manual at
www.vivatmo.com/en/for-doctors/downloads/.
1.1 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.
INFORMATION
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 GmbH6Instructions for use
Initial information
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1.2 Safety information
WARNING
The following conditions can cause malfunction or disturbance to the Vivatmopro and the disposable
mouthpiece:
• High humidity, extreme temperature (“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 7Instructions 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
computers that comply with EN60950‑1, EN60601‑1 or EN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 personal data on the basestation and handheld prior to disposal or service returns.
INFORMATION Bluetooth is activated as long as the basestation is power supplied.

© Bosch Healthcare Solutions GmbH8Instructions for use
Initial information
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1.3 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 healthcare 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 9Instructions 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 GmbH10 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
1
Measurement orders from electronic patient
recordsystem
2
Manage patients, measurements and orders
3
Charging status handheld battery
4
Handheld
4
CONTINUE
connected
4
CONTINUE
disconnected
5
Start measurement
6Settings menu/logout
You see the basestation homescreen when you finished the
installation, see “3 Installation”.
Screen elements
Element Function Element Function
Help
Opens the Help screen.
4
CONTINUE
Close
Closes the current file.

© Bosch Healthcare Solutions GmbH 11Instructions for use
System elements
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Element Function Element Function
4
CONTINUE
Arrow left
Moves one screen backward.
4
CONTINUE
Arrow right
Moves one screen forward.
4
CONTINUE
Orientation beads
Show the current step during the installation
procedure.
4
CONTINUE
User Administration
Disable access control by user accounts.
Notification
New/open notifications available.
4
CONTINUE
Enable/Disable user
Enables or disables access for user in user
management.
4
CONTINUE
View trials / Reconditioning active
Shows the number of measuring trials.
4
CONTINUE
Add new user/patient
Opens the screen for the data input of a new
user/patient.
4
CONTINUE
Comment
Adds a comment to the current patient data
file.
4
CONTINUE
Pencil
Opens the current data file for editing.
4
CONTINUE
Search
Opens a window for entering search criteria.
4
CONTINUE
Export
Exports the current data file.
18PPB
07.04.2016 11:43
PATIENT RECORD
QC
QC !
Quality Control (QC) status
Shows the QC status.
4
CONTINUE
Print
Prints 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
Delete
Deletes the current entry.

© Bosch Healthcare Solutions GmbH12 Instructions for use
System elements
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2.2 Handheld elements
On the handheld, you see the following opterating 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.
When the handheld is placed on the basestation blue
blinking indicates the charging of the battery.
Battery compartment.

© Bosch Healthcare Solutions GmbH 13Instructions for use
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2.3 Handheld display
1
9
10
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
9Measurement mode
10 Device ready for measurement

© Bosch Healthcare Solutions GmbH14 Instructions for use
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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 GmbH 15Instructions for use
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2.4 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 “6.2.2 Performing QC”. A comparison measurement
is performed for a concentration below 5ppb. The outside of the Level0
disposable mouthpiece is white.

© Bosch Healthcare Solutions GmbH16 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. Pick 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.

© Bosch Healthcare Solutions GmbH 17Instructions for use
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WARNING
• After 5 minutes of inactivity, the handheld will turn off automatically.
• The stored measured values and the date, time setting will remain stored in the memory for 5 minutes
when the rechargeable battery might need to be changed.
• Remove the battery if you are not using the device for a prolonged period of time.
• 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”.
3.2 Installing the basestation
3.2.1 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”.
• Manage patient data and measurement orders, see “5 Manage”.
• Change display, see “6 Settings”.
• Perform Ambient NO measurement, see “6.1 Ambient NO”.
• Perform QC-measurement, see “6.2.2 Performing QC”.
• Export and print.

© Bosch Healthcare Solutions GmbH18 Instructions for use
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Administrators can additionally:
• Change QC settings, see “6.2 Quality control (QC)”.
• Change language, see “2.1Setting the language” in Administration instructions.
• Change time and date, see “2.2Setting date and time” in Administration instructions.
• Activate/de-activate auto-lock, see “2.3Setting Auto-Lock” in Administration instructions.
• Install printers and export locations, see “4Printer configuration” and “5.4Export and Backup file configuration” in
Administration instructions.
• Change Vivatmopro handheld used with the basestation, see “5.1.2Release the handheld” in Administration instructions.
• Configure network, see “5.2Network configuration” in Administration instructions.
• Configure HL7 or GDT interfaces, see “5.3Order/result interface” in Administration instructions.
• Manage user accounts, see “6User administration” in Administration instructions.
3.2.2 Onboarding
WARNING
Only use the Vivatmopro basestation with the provided low voltage power supply unit. Attempted use
with other power sources may cause irreparable damage and invalidate the warranty.
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.
3. Plug the main plug into a suitable socket. The Vivatmopro basestation starts automatically.

© Bosch Healthcare Solutions GmbH 19Instructions for use
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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.
Region and Language (Basestation‑Software V1.6.0 and higher)
1. Switch on the basestation, by pressing the ON/OFF button.
2. Select a region
The region selection defines the functionality approved for the region.
The Language Screen is displayed.
3. Select a language.
Date and Time
1. Set up date and time. For details, see “2.2Setting date and time” in Administration instructions.
2. Confirm with DONE after successful setting. The Administrator Account screen opens.
Administrator account
1. Create an administrator account. For details, see “6.1Add new user” in Administration instructions.
2. Select the CONTINUE button after the successful addition of an administrator. The User accounts screen opens.
INFORMATION
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.

© Bosch Healthcare Solutions GmbH20 Instructions for use
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User accounts
1. Select ENABLE to activate the user accounts.
2. Create a new user by entering a user name and a passcode. For details, see “3.2.1User concept” and “6.1Add new user”
in Administration instructions.
3. Select CONTINUE after successful addition of a user and see the list of user accounts.
4. Select the Arrow to leave the list.
5. On the next screen, select the CONTINUE button. The Handheld screen opens.
INFORMATION
When you select the NOT NOW button, the user identification will be deactivated. 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 identification will be deactivated.
Assign handheld
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.