Bosch Vivatmo me Manuale utente

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

Oxycap

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

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

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.

Vivatmo me

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.

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.

Your Vivatmo me

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.

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

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