Bosch Vivatmo pro Manual de usuario

Instructions for use

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

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

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

Initial information

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.

Initial information

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.

Initial information

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.

Initial information

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.

System elements

2 System elements

Basestation frontside

1Handheld

2Charging cradle

3On/Oﬀ button

4Touchscreen

Basestation backside

1Ethernet port

2USB ports

3Power adapter port

2 3 2 3

System elements

2.1 Screen elements

Elements of the basestation homescreen

PATIENTS

AND RESULTS

START NEW

MEASUREMENT

MANAGE

MEASURE

Welcome to Vivatmo pro

Measurement orders from electronic patient

recordsystem

Manage patients, measurements and orders

Charging status handheld battery

Handheld

CONTINUE

connected

CONTINUE

disconnected

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.

CONTINUE

Closes the current ﬁle.

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