Bosch Vivatmo me User manual

English 2
Bosch Healthcare Solutions GmbH
Stuttgarter Straße 130
71332 Waiblingen
Germany
F09G100186_09
Latest change: 04.05.2020
Bosch Healthcare Solutions GmbH
Stuttgarter Straße 130
71332 Waiblingen, Germany Instructions for use

+
-
+
-
+
-
+
-
G
A
F1
Oxycap

© Bosch Healthcare Solutions GmbH2Instructions for use
Vivatmo me
en Content
1 Your Vivatmo me ................................................................................................................................................................................................................ 4
1.1 Welcome to Vivatmo me, the monitoring system for your respiratory disease 4
1.2 Activate your Vivatmo me 5
1.3 Intended use / Indications for use 6
1.4 User interface 8
2 Measurement of FeNO in exhaled breath ...............................................................................................................................................................10
2.1 Attaching the disposable mouthpiece 10
2.2 Performing the measurement 11
2.3 Measurement failed 14
2.4 Interpretation of results 15
2.5 Displaying stored measured values 15
3 Settings / Transmission of Measurement Data.......................................................................................................................................................16
3.1 Deactivate / Activate Bluetooth 16
3.2 Activating / deactivating audio sound 17
3.3 Changing date and time 18
4 Advanced Settings .........................................................................................................................................................................................................19
4.1 Setting the upper and lower thresholds for the traffic light scale 19
4.2 Clearing the memory / reset settings 20

© Bosch Healthcare Solutions GmbH 3Instructions for use
en
5 Maintenance and Troubleshooting............................................................................................................................................................................21
5.1 Battery indicator 21
5.2 Cleaning and Disinfecting 21
5.3 Storage 22
5.4 Reconditioning 23
5.5 Quality Control 24
5.6 Troubleshooting 25
6 Technical information....................................................................................................................................................................................................27
6.1 Device data 27
6.2 EMC information 30
6.3 Symbols 30
6.4 Disposal of device, batteries and mouthpieces 32
6.5 Warranty 33
7 Manufacturer ...................................................................................................................................................................................................................33

© Bosch Healthcare Solutions GmbH4Instructions for use
Vivatmo me
en 1 Your Vivatmo me
1.1 Welcome to Vivatmo me, the monitoring system for your respiratory disease
Please consider before using Vivatmo me:
• Take the time to read these instructions for use carefully before using the monitoring system.
You need to understand the functions, warnings, displays and operations for a safe and reliable use.
• Set the time and date on your Vivatmo me before you begin a measurement.
WARNING Do not use any defective devices or accessories to avoid malfunction or hazardous situations.
If you need service, information, have a problem or want information about data privacy, please visit the Bosch Vivatmo
website at www.vivatmo.com or contact your distributor or the Vivatmo me customer service center at [email protected].
Please have your serial number available when contacting the service center, see 12-digit code on your Vivatmo me
next to the symbol at the bottom of the device.
Please keep these instructions for future reference.
Bosch privacy statement:
This product stores measurement data, but no personal information about the user. Configuration, changes and occur-
ring risks by connection to other devices via Bluetooth® are in the responsibility of the user of Vivatmo me.

© Bosch Healthcare Solutions GmbH 5Instructions for use
Vivatmo me
en
1.2 Activate your Vivatmo me
1. Open the battery compartment on the back of the Vivatmo me as operator.
2. Insert the 4 AAA primary batteries as shown on the inside of the battery compartment.
3. Remove the battery cover.
4. If the batteries are inserted correctly, the device will automatically turn on.
5. After turning on all display icons will be shown and the system displays the software-version.
6. Symbols to attach disposable mouthpiece are shown.
WARNING For safe use:
• Turn device off before battery replacement if batteries are inserted.
• Use batteries from the same type as delivered with the device
(lithium/iron disulfide or alkaline cells).
• The date and time setting will remain stored in the memory for 5 minutes when the batteries
are removed. However, check whether the time and date setting is still correct after the battery
replacement.
• Remove the batteries if you are not using the device for a long period of time. The stored mea-
sured values are retained.

© Bosch Healthcare Solutions GmbH6Instructions for use
en
Your Vivatmo me
1.3 Intended use / Indications for use
Intended use: The Vivatmo me is intended for quantitative
measurement of fractional nitric oxide in human breath.
Indication: Measurement of changes in the fractional
nitric oxide concentration in expired breath aids in evalu-
ating a patient’s response to anti-inflammatory therapy,
as an adjunct to established clinical and laboratory as-
sessments of inflammatory processes such as asthma.
The Bosch Vivatmo me system is a non-invasive self-test-
ing device intended to be used at home (in-vitro diagnos-
tic use) as an aid to monitor airway diseases whilst under
the care of their physician or healthcare expert. Vivatmo
me measurement procedure requires patient’s coopera-
tion by breathing into the device via a disposable mouth-
piece. Patients should be 7 years or older and capable to
complete the breathing maneuver.
The measurement procedure of the Vivatmo me system
generates the fraction of the exhaled breath (FeNO) based
on the recommendations for the measurement of exhaled
respiratory nitric oxide of the European Respiratory Soci-
ety (ERS) and the American Thoracic Society (ATS). FeNO
is recommended by the ATS in the diagnosis of eosinophil-
ic airway inflammation and in determining the likelihood
of responsiveness to anti-inflammatory pharmacological
therapy in individuals with chronic respiratory symp-
toms possibly due to airway inflammation [ATS, 2011].
Vivatmo me should only be used as directed in the
Vivatmo me Instructions for use and as recommended by
healthcare professionals. Regardless of displayed test
results, if signs or symptoms of chest tightness, short-
ness of breath, coughing or wheezing occur, the user
should contact their healthcare professional immediately.
Contra-indications: Not known.

© Bosch Healthcare Solutions GmbH 7Instructions for use
Your Vivatmo me
en
WARNING For individual assignment mark device, if several devices are used in the same household.
When the device shall be used by another patient, continuously stored data must be deleted
to avoid misinterpretation.
The following conditions can influence correct measurement results or cause malfunction or
disturbance to the Vivatmo me and the disposable mouthpiece:
• Smoking or tobacco consumption for at least 30 minutes before the measurement.
• Eating or drinking shortly before the measurement.
• Strenuous exercise.
• Rooms with high air pollution or open flames, for example gas range or tobacco smoke.
• Ingress of moisture or liquid.
Device contains small parts which can lead to choking.
Children shall use the device supervised by an adult only to ensure correct use of the device.
Store the device outside the access of children when not in use.
When liquid ingresses into the device, remove batteries and prevent further usage of the device to avoid malfunction.
Literature
ATS / ERS, 2005: ATS / ERS recommendations for Measurement of Exhaled Respiratory Nitric Oxide.
ATS, 2011: An Official ATS Clinical Practice Guideline: Interpretation of Exhaled Nitric Oxide Levels (FeNO) for Clinical Application.

© Bosch Healthcare Solutions GmbH8Instructions for use
en
Your Vivatmo me
1.4 User interface
Traffic light scale – a bullet point displays the result on the scale
Ask your physician or healthcare professional for interpretation advise
Reconditioning
Trend since last measurement:
The measured value has increased by at least 10 ppb (parts per billion)
The measured value has decreased by 10 ppb (parts per billion) or more
Invalid disposable mouthpiece: Use a new disposable mouthpiece
Attach disposable mouthpiece
Measuring ID
Battery status
Change date and time or device busy
Activate / deactivate audio sound
Activate / deactivate Bluetooth connection
Time and date of the performed measurement
Device ready for measurement
Measured value

© Bosch Healthcare Solutions GmbH 9Instructions for use
Your Vivatmo me
en
A Mouthpiece: Place your lips tightly around the mouthpiece and exhale into the Vivatmo me
Display: Shows current and stored measuring data and device messages
ON / OFF switch: Activate and deactivate the device
ENTER button: Press this button to confirm the selection in the display
ARROW buttons: Press these buttons to change the settings and to access stored measuring data
Breath intensity display LED: During the measurement, you get a feedback on your breath intensity
Blue: Your breath intensity is right
Yellow: Caution, your breath intensity is too weak
Red: Warning, your breath intensity is too strong
Battery compartment: Open the battery compartment to exchange the batteries if required

© Bosch Healthcare Solutions GmbH10 Instructions for use
en
Measurement of FeNO in exhaled breath
2 Measurement of FeNO in exhaled breath
2.1 Attaching the disposable mouthpiece
The Vivatmo me disposable mouthpiece chemically prepares the breath test sample. Human breath is cleaned from
contaminants and stabilized to guarantee reliable test results. Use the disposable mouthpiece directly after opening the
pouch. The disposable mouthpiece must be attached firmly to perform a measurement.
1. Remove the protective cap from the device.
2. Open the pouch of the disposable mouthpiece.
3. Check the device and disposable mouthpiece and do not use when any damage is noted.
4. Attach the disposable mouthpiece firmly and make sure that it fits securely on the device.
The disposable icon on the display stops moving.
5. “Invalid mouthpiece” is shown on the display if more than 5 attempts have been performed with
the same mouthpiece or if the filter capability is used up by the reconditioning.
Remove the mouthpiece and attach a new one.

© Bosch Healthcare Solutions GmbH 11Instructions for use
Measurement of FeNO in exhaled breath
en
WARNING Disposable mouthpiece shall be handled with care for correct measurement results:
• Only use disposable mouthpieces approved for this device.
• Avoid leakage when fitting the disposable to the device.
• Do not clean or dry the disposable mouthpiece.
• Use each disposable mouthpiece for one person and one measurement only, 5 attempts are
maximal possible with 1 mouthpiece. Use the mouthpiece within 15 minutes after opening its
pouch.
• Take care to use regular disposable mouthpieces with transparent cover. Level-0 disposable
mouthpieces with white cover lead to 0 ppb measurements, see chapter ”5.5 Quality Control”.
• Use only disposable mouthpieces from unopened and undamaged pouches that has not
expired. See the expiration date on the package.
2.2 Performing the measurement
For measuring the FeNO value, you have to exhale through the device with a constant breathing rate:
1. Turn ON the device, see “1.2 Activate your Vivatmo me”.
2. Attach a new disposable mouthpiece, see chapter “2.1 Attaching the disposable mouthpiece”.
3. Press the ENTERbutton to start the regeneration process and wait until the regeneration process
is completed. This may take up to 100 seconds. During the regeneration process segments of
the display will be animated to indicate the regeneration process is working and the remaining
regeneration time is shown.

© Bosch Healthcare Solutions GmbH12 Instructions for use
en
Measurement of FeNO in exhaled breath
If the Vivatmo me device has been stored in warm and humid environment or not been in use
for a longer time, the wrench symbol may appear and a reconditioning will start automatically
to provide consistent measurement performance, see chapter “5.4 Reconditioning”.
4. When the display shows the exhaling icon, perform the measurement within 60seconds (see
next steps). The LED on the back of the device turns blue.
5. Turn the device display downwards and make sure you can see the LED at the back
of the device. Sit in a relaxed position, inhale deeply through the mouth and lift the
device to your mouth. Avoid inhalation through the nose, to exclude influence of nasal
NO concentrations.
6. Exhale through the disposable mouthpiece in a controlled manner like blowing into a flute or
cooling a hot drink for 10 seconds. Feedback given by the LED on the back of the device:
LED color Breathing advise for your exhalation
blue correct
yellow too weak, caution
red too strong, warning

© Bosch Healthcare Solutions GmbH 13Instructions for use
Measurement of FeNO in exhaled breath
en
If the measurement is successful, the LED flashes blue and the result appears on the display.
The result “5 ppb -LO-” represents a result below the lower detection limit of the device.
The result “300 ppb -HI-” represents a result above the upper detection limit of the device.
7. All results are automatically stored on the device. If the measurement fails, the icon
“exhalation failed” appears on the display.
8. Remove and discard the disposable mouthpiece, see chapter “6.4 Disposal of device, batteries
and mouthpieces”.
9. Place the protective cap on the device.
To save battery power hold the ON / OFF button until the display turns off. The device might show being busy with the clock
icon blinking. If you press the ON / OFF button in this mode, the device will turn off afterwards. The device will turn off
automatically after 5 minutes of inactivity.

© Bosch Healthcare Solutions GmbH14 Instructions for use
en
Measurement of FeNO in exhaled breath
2.3 Measurement failed
Measurement failed when
• the exhalation through the device was excessively weak or strong.
• the measurement was not performed within 60 seconds after completed regeneration process.
Display shows exhalation failed, the LED flashs red and an audio signal occurs.
The regeneration process must be repeated for a new measurement trial:
1. If the clock icon is blinking, the device is busy. Wait until the blinking stops.
2. Press the ENTER button.
3. When the device is ready to measure, perform steps 3 to 7 of the procedure, see chapter
“2.2 Performing the measurement”.

© Bosch Healthcare Solutions GmbH 15Instructions for use
Measurement of FeNO in exhaled breath
en
2.4 Interpretation of results
The measured value is shown on the display. The bullet point under traffic light scale ranks the result relative to the
patient’s threshold references.
INFORMATION Interpretation of the results and setting of thresholds must be advised by your physician
or healthcare professional.
Default values set for the traffic light scale for adults in accordance with the ATS Guideline 2011,
see “Literature” in chapter 1.3:
Green: < 25 ppb, Yellow: 25 ppb - 50 ppb, Red: > 50 ppb
For children below 12 years ATS guideline defines:
Green: < 20 ppb, Yellow: 20 ppb - 35 ppb, Red: > 35 ppb
If you have further questions, contact your distributor or the Vivatmo me service center.
2.5 Displaying stored measured values
The Vivatmo me automatically stores up to 1,000 measured FeNO values identified by time, date, and ID number. The
measured values are stored in descending order starting with the latest. You can retrieve the measured values anytime.
• Press one of the ARROW buttons to show older measured values.
• Press the ENTER button to exit the view.

© Bosch Healthcare Solutions GmbH16 Instructions for use
en
Settings / Transmission of Measurement Data
3 Settings / Transmission of Measurement Data
3.1 Deactivate / Activate Bluetooth
Measurement data can be transmitted encryptedly via Bluetooth to a remote device like a smartphone with the Vivatmo app
(see www.vivatmo.com).
1. Change Bluetooth by holding the ENTER button for 2 seconds.
The settings toolbar appears.
2. In the menu screen, use the ARROW buttons to select the Bluetooth icon.
The icon starts flashing.
3. Press the ENTER button to activate / deactivate Bluetooth.
Press one of the ARROW button to confirm selection.
4. To exit the basic settings toolbar press the left or right ARROWbutton repeatedly until icons
stop flashing, then press the ENTER button.

© Bosch Healthcare Solutions GmbH 17Instructions for use
Settings / Transmission of Measurement Data
en
3.2 Activating / deactivating audio sound
1. Hold the ENTER button for 2 seconds. The settings toolbar appears.
2. In the menu screen, use the ARROW buttons to select the Audio icon. The selected icon flashes.
3. Press the ENTER button to activate / deactivate the sound. If the check mark is shown, the audio
is on. Press one of the ARROWbuttons to confirm selection.
4. To exit the basic settings toolbar press the left or right ARROWbutton repeatedly until no icons
are flashing, then press the ENTER button.

© Bosch Healthcare Solutions GmbH18 Instructions for use
en
Settings / Transmission of Measurement Data
3.3 Changing date and time
1. Hold the ENTER button for 2 seconds.
The settings toolbar appears.
2. In the menu screen, use the ARROW buttons to select the Clock icon, the icon starts flashing,
then press the ENTER button.
3. Use the ARROWbuttons to choose the date format dd.mm.yy or mm/dd/yy, then press the
ENTER button.
4. Use the ARROW buttons to select the year, then press the ENTERbutton.
5. Use the ARROW buttons to select the month, then press the ENTERbutton.
6. Use the ARROW buttons to select the day, then press the ENTERbutton.
7. Use the ARROW buttons to switch between 0-24h and 0-12h,AM / PM time format, then
press the ENTERbutton.
8. If you have chosen 0-12h time format, you can select between AM and PM, then press the
ENTERbutton.
9. Use the ARROW buttons to set the hours, then press the ENTERbutton. Then set the minutes
and press the ENTERbutton.
10. To exit the basic settings toolbar, press the left or right ARROWbutton repeatedly until icons
stop flashing, then press the ENTERbutton.