Table of Contents
Troubleshooting
Related Manuals for Bosch Vivatmo me
Summary of Contents for Bosch Vivatmo me
- Page 1 Bosch Healthcare Solutions GmbH Stuttgarter Straße 130 71332 Waiblingen Germany English Bosch Healthcare Solutions GmbH F09G100186_09 Stuttgarter Straße 130 Latest change: 04.05.2020 71332 Waiblingen, Germany Instructions for use...
- Page 2 Oxycap...
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Page 4: Table Of Contents
Vivatmo me Content Your Vivatmo me ..........................................Welcome to Vivatmo me, the monitoring system for your respiratory disease Activate your Vivatmo me Intended use / Indications for use User interface Measurement of FeNO in exhaled breath ................................Attaching the disposable mouthpiece Performing the measurement... - Page 5 Maintenance and Troubleshooting .................................... Battery indicator Cleaning and Disinfecting Storage Reconditioning Quality Control Troubleshooting Technical information ........................................Device data EMC information Symbols Disposal of device, batteries and mouthpieces Warranty Manufacturer ........................................... Instructions for use © Bosch Healthcare Solutions GmbH...
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Page 6: Your Vivatmo Me
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. © Bosch Healthcare Solutions GmbH... -
Page 7: Activate Your Vivatmo Me
Vivatmo me 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. -
Page 8: Intended Use / Indications For Use
[ATS, 2011]. tic use) as an aid to monitor airway diseases whilst under Vivatmo me should only be used as directed in the Vivatmo me Instructions for use and as recommended by the care of their physician or healthcare expert. Vivatmo me measurement procedure requires patient’s coopera-... - Page 9 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.
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Page 10: User Interface
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 © Bosch Healthcare Solutions GmbH Instructions for use... - Page 11 Your Vivatmo me Mouthpiece: Place your lips tightly around the mouthpiece and exhale into the Vivatmo me Display: Shows current and stored measuring data and device messages ON / OFF switch: Activate and deactivate the device ENTER button: Press this button to confirm the selection in the display ...
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Page 12: Measurement Of Feno In Exhaled Breath
Measurement of FeNO in exhaled breath Attaching the disposable mouthpiece The Vivatmo me disposable mouthpiece chemically prepares the breath test sample. Human breath is cleaned from contaminants and stabilized to guarantee reliable test results. Use the disposable mouthpiece directly after opening the pouch. -
Page 13: Performing The Measurement
For measuring the FeNO value, you have to exhale through the device with a constant breathing rate: 1. Turn ON the device, see “1.2 Activate your Vivatmo me”. 2. Attach a new disposable mouthpiece, see chapter “2.1 Attaching the disposable mouthpiece”. - Page 14 Measurement of FeNO in exhaled breath If the Vivatmo me device has been stored in warm and humid environment or not been in use for a longer time, the wrench symbol may appear and a reconditioning will start automatically to provide consistent measurement performance, see chapter “5.4 Reconditioning”.
- Page 15 To save battery power hold the ON / OFF button until the display turns off. The device might show being busy with the clock icon blinking. If you press the ON / OFF button in this mode, the device will turn off afterwards. The device will turn off automatically after 5 minutes of inactivity. Instructions for use © Bosch Healthcare Solutions GmbH...
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Page 16: Measurement Failed
1. If the clock icon is blinking, the device is busy. Wait until the blinking stops. 2. Press the ENTER button. 3. When the device is ready to measure, perform steps 3 to 7 of the procedure, see chapter “2.2 Performing the measurement”. © Bosch Healthcare Solutions GmbH Instructions for use... -
Page 17: Interpretation Of Results
Displaying stored measured values The Vivatmo me automatically stores up to 1,000 measured FeNO values identified by time, date, and ID number. The measured values are stored in descending order starting with the latest. You can retrieve the measured values anytime. -
Page 18: Settings / Transmission Of Measurement Data
Press one of the ARROW button to confirm selection. 4. To exit the basic settings toolbar press the left or right ARROW button repeatedly until icons stop flashing, then press the ENTER button. © Bosch Healthcare Solutions GmbH Instructions for use... -
Page 19: Activating / Deactivating Audio Sound
Press one of the ARROW buttons to confirm selection. 4. To exit the basic settings toolbar press the left or right ARROW button repeatedly until no icons are flashing, then press the ENTER button. Instructions for use © Bosch Healthcare Solutions GmbH... -
Page 20: Changing Date And Time
9. Use the ARROW buttons to set the hours, then press the ENTER button. Then set the minutes and press the ENTER button. 10. To exit the basic settings toolbar, press the left or right ARROW button repeatedly until icons stop flashing, then press the ENTER button. © Bosch Healthcare Solutions GmbH Instructions for use... -
Page 21: Advanced Settings
If you have further questions, contact the Vivatmo me service center. In order to access the advanced settings, press the ENTER button and the right ARROW button for 3 seconds. -
Page 22: Clearing The Memory / Reset Settings
The Clear memory icon is shown and flashes. 4. To exit the advanced settings toolbar, press the ARROW buttons until no icons are flashing, then press the ENTER button to return to the main screen. © Bosch Healthcare Solutions GmbH Instructions for use... -
Page 23: Maintenance And Troubleshooting
1. Turn off the device. Wash hands thoroughly with soap and water. 2. Wipe the entire Vivatmo me with disinfectant wipes with maximum 30 % alcohol e.g. Mikrobac Tissues (Bode Chemie GmbH) or Sagrotan wipes (Reckitt Benckiser) or with a soft cloth, moistened with soap cleaning agents. Carefully wipe around openings. -
Page 24: Storage
• Always attach the protective cap when Vivatmo me is not in use. • Keep the Vivatmo me and its components in a clean, cool and dry place. The following conditions can cause damage and may cause malfunction to the Vivatmo me and the WARNING disposable mouthpiece: •... -
Page 25: Reconditioning
Reconditioning If the Vivatmo me device has been stored in warm and humid environment or not been in use for a longer time, the wrench symbol may appear and a reconditioning is required to provide consistent measurement performance. In this case the wrench symbol appears during the regeneration process on the pacifier screen and the device automatically starts the reconditioning. -
Page 26: Quality Control
• Change the batteries if E-6 and the blinking battery symbol appears during reconditioning, see chapter “1.2 Activate your Vivatmo me”. • Change the disposable mouthpiece if the “Invalid mouthpiece” screen appears during recondi- tioning, see chapter “2.1 Attaching the disposable mouthpiece”. -
Page 27: Troubleshooting
Maintenance and Troubleshooting Troubleshooting When using the Vivatmo me, an error message may indicate a problem. The following table gives explanations of the error messages as well as recommendations for solving the problem. Display Description Solution Regeneration or reconditioning process Wait for the process to be completed. - Page 28 If you have any problems which you cannot solve with these Instructions for use or the device shows unexpected opera- tions, contact your distributor or the Vivatmo me customer service center at service@vivatmo.com. For the contact data see chapter “7 Manufacturer”. Please indicate the following information: •...
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Page 29: Technical Information
Technical information Device data Product description FeNO monitoring system Model Vivatmo me, catalogue number F09G100149 Measuring range 5 ppb to 300 ppb Accuracy ± 5 ppb below 50 ppb, ±10 % for ≥50 ppb, ± 15 % for ≥ 160 ppb... - Page 30 Electromagnetic emissions CISPR 11 Group 1 (battery operated) Electromagnetic immunity EN 61000-4-2, EN 61000-4-3 (battery operated), EN 61000-4-8 Sensor Chemical field-effect transistor Data transfer Bluetooth Smart (low energy), 2.4 GHz frequency band © Bosch Healthcare Solutions GmbH Instructions for use...
- Page 31 Further purchase: Vivatmo Oxycap mouthpieces (catalogue number F09G100152), Level 0 mouthpieces (catalogue number F09G100174). Limitations of the System: Exchange your Vivatmo me at the latest 3 years after manufacturing date. Information concerning candidates of the REACH regulation can be found at www.vivatmo.com.
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Page 32: Emc Information
Important information regarding electromagnetic compatibility (EMC) Hereby, Bosch Healthcare Solutions GmbH, declares that the radio equipment type Vivatmo me is in compliance with Directive 2014/53/EU. The full text of the EU declaration of conformity is available at the following internet address: https://www.vivatmo.com/en/service-support/additional-information.html... - Page 33 98 / 79 / EEC IVD Directive WARNING Important information to avoid a Keep dry hazardous situations INFORMATION Important advise IP Protection class Use-by date Bluetooth compatible For single-use only Manufacturing date Batch number Regulatory compliance mark Australia Instructions for use © Bosch Healthcare Solutions GmbH...
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Page 34: Disposal Of Device, Batteries And Mouthpieces
Technical information The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Bosch Healthcare Solutions GmbH is under license. Disposal of device, batteries and mouthpieces INFORMATION Delete the data on the device prior to disposal (see chapter 4.2). -
Page 35: Warranty
WARNING Do not disassemble Vivatmo me or its components, and do not try to repair it by yourself. Any changes or modifications to Vivatmo me that are not approved by the manufacturer may cause malfunction and result in the warranty becoming invalid. - Page 36 Manufacturer © Bosch Healthcare Solutions GmbH Instructions for use...