Bosch Vivatmo me Instructions For Use Manual Download

Page: 33 / 36

Instructions for use

Technical information

Manufacturer address

Reference number / type part number

The IVD product meets the
requirements of applicable
European directives.

Applied part type BF as per
EN 60601-1

Consult instructions for use

In vitro diagnostic medical device

98 / 79 / EEC IVD Directive

WARNING

Important information to avoid a
hazardous situations

Keep dry

INFORMATION

Important advise

IP Protection class

Use-by date

Bluetooth

compatible

For single-use only

Manufacturing date

Batch number

Regulatory compliance mark Australia

Summary of Contents for Vivatmo me

Page 1: ...h 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 ...

Page 2: ... G A F 1 Oxycap ...

Page 3: ......

Page 4: ...n 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 a...

Page 5: ...ttery 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 ...

Page 6: ...oid 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 service vivatmo com Please have your serial number available when contacting the service center see 12 digit code on your Vivatmo me next to th...

Page 7: ...hown 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 H...

Page 8: ...vice 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 recommende...

Page 9: ...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 ing...

Page 10: ... 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...

Page 11: ...e ENTER button Press this button to confirm the selection in the display ARROW buttons Press these buttons to change the settings and to access stored measuring data Breath intensity display LED During the measurement you get a feedback on your breath intensity Blue Your breath intensity is right Yellow Caution your breath intensity is too weak Red Warning your breath intensity is too strong Batte...

Page 12: ...uch The disposable mouthpiece must be attached firmly to perform a measurement 1 Remove the protective cap from the device 2 Open the pouch of the disposable mouthpiece 3 Check the device and disposable mouthpiece and do not use when any damage is noted 4 Attach the disposable mouthpiece firmly and make sure that it fits securely on the device The disposable icon on the display stops moving 5 Inva...

Page 13: ...disposable mouthpieces with white cover lead to 0 ppb measurements see chapter 5 5 Quality Control Use only disposable mouthpieces from unopened and undamaged pouches that has not expired See the expiration date on the package 2 2 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 V...

Page 14: ...n 60 seconds see next steps The LED on the back of the device turns blue 5 Turn the device display downwards and make sure you can see the LED at the back of the device Sit in a relaxed position inhale deeply through the mouth and lift the device to your mouth Avoid inhalation through the nose to exclude influence of nasal NO concentrations 6 Exhale through the disposable mouthpiece in a controlle...

Page 15: ...ce 7 All results are automatically stored on the device If the measurement fails the icon exhalation failed appears on the display 8 Remove and discard the disposable mouthpiece see chapter 6 4 Disposal of device batteries and mouthpieces 9 Place the protective cap on the device To save battery power hold the ON OFF button until the display turns off The device might show being busy with the clock...

Page 16: ...erformed within 60 seconds after completed regeneration process Display shows exhalation failed the LED flashs red and an audio signal occurs The regeneration process must be repeated for a new measurement trial 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 ch...

Page 17: ...in accordance with the ATS Guideline 2011 see Literature in chapter 1 3 Green 25 ppb Yellow 25 ppb 50 ppb Red 50 ppb For children below 12 years ATS guideline defines Green 20 ppb Yellow 20 ppb 35 ppb Red 35 ppb If you have further questions contact your distributor or the Vivatmo me service center 2 5 Displaying stored measured values The Vivatmo me automatically stores up to 1 000 measured FeNO ...

Page 18: ...ne with the Vivatmo app see www vivatmo com 1 Change Bluetooth by holding the ENTER button for 2 seconds The settings toolbar appears 2 In the menu screen use the ARROW buttons to select the Bluetooth icon The icon starts flashing 3 Press the ENTER button to activate deactivate Bluetooth Press one of the ARROW button to confirm selection 4 To exit the basic settings toolbar press the left or right...

Page 19: ...bar appears 2 In the menu screen use the ARROW buttons to select the Audio icon The selected icon flashes 3 Press the ENTER button to activate deactivate the sound If the check mark is shown the audio is on 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 ...

Page 20: ...lect the year then press the ENTER button 5 Use the ARROW buttons to select the month then press the ENTER button 6 Use the ARROW buttons to select the day then press the ENTER button 7 Use the ARROW buttons to switch between 0 24 h and 0 12 h AM PM time format then press the ENTER button 8 If you have chosen 0 12 h time format you can select between AM and PM then press the ENTER button 9 Use the...

Page 21: ...cess the advanced settings press the ENTER button and the right ARROW button for 3 seconds 4 1 Setting the upper and lower thresholds for the traffic light scale The default values set for the traffic light scale are the reference values for adults in accordance with the ATS Guideline 2011 see chapter 2 4 Interpretation of results 1 Use the ARROW buttons to select the Thresholds icon The icon star...

Page 22: ...utton to return to the main screen 4 2 Clearing the memory reset settings 1 Use the ARROW buttons to select the Clear memory icon The icon start flashing Press the ENTER button to select the flashing icon 2 Use the ARROW buttons to select the check mark 3 Press the ENTER button to confirm the clearing The Clear memory icon is shown and flashes 4 To exit the advanced settings toolbar press the ARRO...

Page 23: ...set of batteries see chapter 1 2 Activate your Vivatmo me 5 2 Cleaning and Disinfecting Clean the device regularly or when used by another patient 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 so...

Page 24: ...e cap when Vivatmo me is not in use Keep the Vivatmo me and its components in a clean cool and dry place WARNING The following conditions can cause damage and may cause malfunction to the Vivatmo me and the disposable mouthpiece Storage in high humidity high temperature direct sun radiation or high exposure to dust or volatile substances e g disinfectants or nail polish remover Places that are sub...

Page 25: ...ess on the pacifier screen and the device automatically starts the reconditioning 1 The wrench symbol indicates that the reconditioning process is working Segments of the display will be animated and the remaining reconditioning time is shown in minutes 2 The system beeps and blinks 3 times blue when reconditioning is finished and the device shows the Exhaling icon when it is ready to measure Perf...

Page 26: ...outhpiece If you push the ON OFF button OFF appears as long as the reconditioning is active 5 5 Quality Control Quality Control lets you know that your device gives reliable results Perform quality control when You dropped the device You want to make sure you are testing correctly Confirm a measurement below the detection limit of 5 ppb by using a white Level 0 disposable mouthpiece Above the dete...

Page 27: ...ible number of measurements 20 See display for number of remaining measurements E 2 Maximum number of permissible measurements reached Device does not perform anymore measurements Dispose Vivatmo me see chapter 6 4 Disposal of device batteries and mouthpieces E 4 Humidity too high Check ambient conditions and take a new mouthpiece see chapter 2 1 Attaching the disposable mouthpiece E 5 Ambient tem...

Page 28: ...one The device will not turn on Batteries are empty Replace batteries with new ones see chapter 1 2 Activate your Vivatmo me Batteries are inserted the wrong way Ensure the batteries are inserted with correct polarity 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...

Page 29: ...0 for 50 ppb 15 for 160 ppb expressed as the upper lower confidence limit of 95 Precision 5 ppb below 50 ppb 10 for 50 ppb 15 for 160 ppb expressed as one standard deviation for replicate measurements with the same instrument Lifetime device service life memory capacity 1 000 measurements Power source 4 AAA batteries 1 5 V Useful life of primary batteries Lithium iron disulfide up to 60 attempts a...

Page 30: ...01 1 11 IP22 protection against solid particles 12 5 mm and ingress of dripping water when tilted up to 15 for basic safety but not for function Maximum surface temperature 58 C touch time 60 seconds 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 Bluet...

Page 31: ... cm x 22 4 cm Package contents Vivatmo me device 5 disposable mouthpieces Oxycaps 4 batteries protec tive cap detachable part Instructions for use Disposable mouthpiece single use accessory Measurement within 15 minutes after opening the pouch Use is limited to 5 attempts and expiration date Lifetime disposable 2 years from date of manufacturing Further purchase Vivatmo Oxycap mouthpieces catalogu...

Page 32: ...c emission values for medical equipment This medical device manufactured by the company complies with the standard EN60601 1 2 2015 both in terms of immunity and of emissions and does therefore not need any service and maintenance regarding EMC and ESD over lifetime For manufacturers declaration regarding EMC see www vivatmo com Please note that portable and mobile HF communication systems may int...

Page 33: ...e European directives Applied part type BF as per EN60601 1 Consult instructions for use In vitro diagnostic medical device 98 79 EEC IVD Directive WARNING Important information to avoid a hazardous situations Keep dry INFORMATION Important advise IP Protection class Use by date Bluetooth compatible For single use only Manufacturing date Batch number Regulatory compliance mark Australia ...

Page 34: ...r human health from uncontrolled waste disposal Turn in the device or recycle in order to promote the sustainable reuse of material resources in compliance with EU directive 2012 19 EU The used or expired device and batteries should be recycled in compliance with the local recycling program for electronic equipment Dispose used batteries in compliance with the national local regulations for the di...

Page 35: ... covered by 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 7 Manufacturer Bosch Healthcare Solutions GmbH Stuttgarter Str 130 71332 Waiblingen Germany E Mail service vivatmo com Internet www ...

Page 36: ... Bosch Healthcare Solutions GmbH 34 Instructions for use en Manufacturer ...

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