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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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

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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

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.

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.

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.

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