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

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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

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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

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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.