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

© Bosch Healthcare Solutions GmbH 3Instructions for use
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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

© Bosch Healthcare Solutions GmbH4Instructions for use
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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.