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Bedfont NObreath FeNO User Manual

Fractional exhaled nitric oxide device
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For Healthcare Professionals only
NObreath
®
Fractional Exhaled Nitric Oxide (FeNO) Device
User Manual
FeNO testing without limits.

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Summary of Contents for Bedfont NObreath FeNO

  • Page 1 For Healthcare Professionals only NObreath ® Fractional Exhaled Nitric Oxide (FeNO) Device User Manual FeNO testing without limits.

  • Page 2: Definitions

    NOTE: Only technical data and no patient data is collected by Bedfont®. NOTE: The NObreath® should be charged for a minimum of 24 hours before first use. NOTE: The default PIN for the NObreath® is 0000. Bedfont® strongly advises that this PIN is changed upon installation and set-up of the device.
  • Page 3 NOTE: Ensure the patient inhales through the mouth, before exhaling through the mouthpiece. NOTE: Bedfont® advise the NObreath® is charged monthly to ensure calibration data is not lost. NOTE: When selecting an accessory for the NObreath® device, please be advised that an accessory not recommended by Bedfont®...
  • Page 4 The user might need to take mitigation measures, such as relocating or re-orienting the equipment. NOTE: Bedfont® will make available on request service training to appropriately qualified personnel. Official Bedfont Distributor USA Representative for Sales, Service & Support:...

  • Page 5: Table Of Contents

    Contents Definitions ............................1 Important Information/Reminders ..................... 1 Introduction ............................5 Compliance ............................5 Intended Use ............................5 Contraindications ..........................6 Parts and accessories .......................... 6 Instrument Layout..........................7 Installation and Set-up ........................8 User Interface ........................... 11 Demo mode ............................12 Performing a Breath Test ........................

  • Page 6: Introduction

    Introduction The User Manual provides instructions on how to operate NObreath® FeNO device and its accessories. It contains relevant information about the device, its uses and its care, including step- by-step instructions with screens and illustrations. Compliance NObreath® is CE marked according to the Medical Device Directive 93/42/EEC. NObreath®...

  • Page 7: Contraindications

    Contraindications There are no known contraindications. Parts and accessories Quick Start Guide 1. NObreath® Dock - Discontinued 7. Microfiber cloth 2. 1.8m USB cable 8. Quick Start Guide 3. Mains plug and universal adaptors 9. Screwdriver 4. NObreath® Forum information 10.

  • Page 8: Instrument Layout

    Instrument Layout 1. ON/OFF switch 5. Manufacturer label 2. Touchscreen 6. Vent hole 3. Mouthpiece aperture 7. Serial label 4. Screw 8. Vent hole 9. USB port...

  • Page 9: Installation And Set-Up

    When selecting an accessory for the NObreath® device, please be advised that an accessory not recommended by Bedfont® may result in loss of performance and damage to the NObreath® device. The product warranty does not cover product failure or damage resulting from use with non- approved accessories.
  • Page 10 How to charge the NObreath® The NObreath® FeNO device comes with a charging cable to keep the device at hand and fully charged. NOTE: The NObreath® should be charged for a minimum of 24 hours before first use. NOTE: It is best practice to not let the battery run flat. If the NObreath® does not switch on, or displays the battery symbol on the last bar of charge, the NObreath®...
  • Page 11 Contact coVita to schedule a complimentary overview/training of the NObreath® Official Bedfont Distributor USA Representative for Sales, Service & Support: coVita 212 Cottage Grove Ave Suite C Santa Barbara, CA 93101 Tel: 800.707.5751 Fax: 800.721.2377 Email: service@covita.net Website: www.covita.net...

  • Page 12: User Interface

    User Interface Home Screen 1. Information button 2. Battery status 3. Adult breath test 4. Child breath test 5. Demo mode 6. Patient profiles 7. Settings The information screen displays information about the device and sensor. Settings Menu Page 1 1.

  • Page 13: Demo Mode

    Settings Menu Page 2 1. Increase screen brightness 2. Decrease screen brightness 3. Enable/disable Bluetooth® 4. Bluetooth® pairing PIN 5. Go to Settings Menu Page 1 Demo mode The NObreath® has an in-built demonstration video of the breath test process. It is recommended to watch this video prior to using the device for the first time.
  • Page 14 The zero screen will briefly display as in a real test. A demonstration will run through the breath test process. The whole test will be shown, but at an accelerated speed.
  • Page 15 Only a successful test will be demonstrated. Once the result is displayed, the demo is complete. Press the home icon to return to the home screen.

  • Page 16: Performing A Breath Test

    Performing a Breath Test Open and insert a new mouthpiece into the NObreath® device. To start a breath test, select either the adult or child patient. As prompted onscreen, take a deep breath. WARNING: Do not inhale through the mouthpiece. NOTE: Ensure the patient inhales through the mouth, before exhaling through the mouthpiece.
  • Page 17 The onscreen flow meter will guide the patient on the exhalation rate: Keep the Keep the Keep the dial car in the middle car in the middle Follow the bubbles. in the green area. of the road. of the road. A green tick onscreen indicates a successful test.

  • Page 18: Patient Profiles

    If the PIN has not been entered in the last 30 minutes, the 4-digit code will be required before the patient profiles can be accessed. NOTE: If the PIN has been forgotten, please contact Bedfont® or its local distributor to reset it.
  • Page 19 A list of patient profiles will show onscreen. Create a new patient profile To create a new profile, choose an empty name slot. Use the keypad to enter a name or reference. Click the save icon to create the profile. To cancel, press the back arrow to return to the list of profiles or the home icon to return to the main screen.
  • Page 20 Once the profile has been created the following options will become available: 1. See a graph of results 2. Delete the patient profile 3. Take an adult breath test 4. Take a child breath test 5. Return to the profile list 6.
  • Page 21 Edit a patient profile To edit a patient’s profile, select their name/ID from the list. Use the keypad to edit the profile. Click the save icon to save the changes. To cancel, press the back arrow to return to the list of profiles or the home icon to return to the main screen.
  • Page 22 Press the red ‘x’ to delete the patient profile. Press the tick to confirm. The profile will be deleted the profile screen will be displayed.

  • Page 23: Maintenance

    The NObreath® has been validated for up to 29,000 tests when used as instructed and properly maintained and serviced. The number of tests can be periodically checked within the settings of the device; when 29,000 tests are reached a service is recommended. Contact Bedfont® or the local service centre.

  • Page 24: Quality Check

    NObreath® is within specification. The 2-step quality check will be carried out using filtered ambient air and 100 ppb Nitric Oxide. Bedfont® or the local service center can do this or a Quality Check CaliBag® kit can be purchased separately (see Quality Check CaliBag® component layout below).
  • Page 25 How to carry out a Quality Check for 0 ppb Attach the Scrubber Adapter to the Scrubber. CAUTION: NO scrubber contains potassium permanganate and should not be tampered with and should not be exposed to skin. Next, attach the scrubber to the CaliAdapter. Insert the Bung into the bottom vent hole on the back of the NObreath®.
  • Page 26 Insert the other end of the CaliAdapter into the NObreath®. Press the Settings icon. Press the Ambient Test icon. An hourglass will appear onscreen while the NObreath® performs the Quality Check without gas.
  • Page 27 A reading will appear onscreen; a successful Quality Check will display an NO reading ≤ 5 ppb. If the NO reading is > 5 ppb, please follow the next steps on replacing the NO scrubber and performing a Quality Check with gas. Remove the Bung from the NObreath®.
  • Page 28 How to replace the NO Scrubber Please ensure the NObreath® device is switched off before removing the back cover. Using the screwdriver provided with the NObreath®, unscrew the screw on the back of the device. Remove the back cover by sliding and lifting it off.
  • Page 29 Slide out the scrubber then lift to remove. CAUTION: NO scrubber contains potassium permanganate and should be disposed of as hazardous waste in accordance with local waste disposal regulations. Using the same NO Scrubber from the Quality Check without gas, insert this into the NObreath®. Please ensure the CaliAdapter and Scrubber Adapter have been removed from the scrubber before inserting into the NObreath®.
  • Page 30 How to carry out a Quality Check with Gas Attach the Bag Adapter to the rubber end of the CaliAdapter. Ensure both Bag Clamps on the Quality Check Bag are closed and remove a Blue Plug from one end. NOTE: Make sure the Quality Check Bag is being used. Insert the Bag Adapter into the Quality Check Bag.
  • Page 31 Turn on the NObreath®. With the Quality Check Bag attached, insert the CaliAdapter into the NObreath®. Press the Settings icon. Press the Ambient Test icon.
  • Page 32 When an hourglass appears, open the clamp while the NObreath® performs the Quality Check with gas. The device will automatically draw gas from the Quality Check Bag. A reading will appear on-screen; a successful Quality Check will display an NO reading within ± 10% of the gas concentration written on the Quality Check Bag label.
  • Page 33 2. Send the device back to Bedfont® or local service center for investigation. 3. Replace with a pre-calibrated sensor; Bedfont® or the local service center can do this for or a sensor replacement kit can be purchased separately which is supplied with replacement...

  • Page 34: Calibration Using A Calibag

    Calibration using a CaliBag® NOTE: The device must be calibrated annually at the following temperature of 21°C ± 4°C (17°C - 24°C) or 70°F ± 7°F (63°F - 77°F). The device will indicate whether the temperature range is out of specification by the following. Leave device in an atmospheric temperature of 21°C ±...
  • Page 35 Insert the Bung into the bottom vent hole on the back of the NObreath® and turn the device on. Press the Settings icon, followed by the Service Area icon. Press the Calibration icon to begin. Use the arrows to adjust the NO concentration on- screen to match the value of the NO concentration written on the CaliBag®.
  • Page 36 With the CaliBag® attached, insert the CaliAdapter into the NObreath®. Press the next arrow once to continue. NOTE: Make sure the calibration gas CaliBag® is being used. Open the Bag Clamp and press the next arrow to continue. An hourglass will display on-screen as the device will automatically calibrate, drawing the gas from the CaliBag®.
  • Page 37 NObreath® is within specification. The 2-step quality check will be carried out using filtered ambient air and 100ppb Nitric Oxide. Alternatively the unit can be sent back to Bedfont® or local service provider.
  • Page 38 Possible Cause Recommended Action The sensor requires The calibration or change of the sensor and the replacement of calibrating or changing the NO scrubber is due by the and the NO scrubber date displayed onscreen. requires replacing within ≤ 30 days. This reminder will be displayed every day until it has been reset by performing a sensor...
  • Page 39 Possible Cause Recommended Action The NObreath® is due The NObreath® is due its full its full service in ≤ 30 service by the date displayed. days. A service reminder will be displayed every day until a full service has been carried out by a trained engineer.
  • Page 40 Cleaning Bedfont® recommends wiping the instrument’s external surfaces with a product specifically developed for this purpose. An EPA registered alcohol free disinfectant should be used, such as Sani- Cloth AF3 Germicidal Disposable Wipe. Cleaning should be performed following the instructions for use specified by the manufacturer of the EPA registered disinfectant.

  • Page 41: Settings

    Settings Change the date/time To change the date or time, press the edit date/time icon on the 1 page of the settings menu. Select either d-m-y or m-d-y for the date format and 12h or 24h for the time format. The purple circle, , indicates the selected option.
  • Page 42 To change the PIN number, press the change PIN icon from the 1 page of the settings menu. A prompt will ask for the current PIN to be entered. If the PIN has been forgotten, please contact Bedfont® or its local distributor to reset it.
  • Page 43 Enter the current PIN and press the next arrow to proceed. A prompt will then ask for a new PIN number to be entered. Enter a new memorable 4 digit code and press the next arrow to continue.

  • Page 44: Enable/Disable Pin

    A prompt will ask for the new PIN number to be re-entered for confirmation. Re-enter the PIN to confirm the new 4 digit code and press the tick to register the change. To cancel, press the back arrow to return to the settings menu or the home icon to return to the main screen.
  • Page 45 A prompt will ask for the PIN number to be entered in order to disable the PIN function. Once the PIN function is disabled, it will be crossed out in the settings menu. To re-enable the PIN function, simply press the enable/disable button again and re-enter the PIN to confirm.
  • Page 46 Select either the adult or child test mode to change the flow-meter style. The current flow-meter style will be highlighted. Select the new style and press the save icon to register.
  • Page 47 The new flow-meter style will now be used for that breath test mode and the relevant demo mode. Press the back arrow to return to the settings menu or the home icon to return to the main screen. Ambient air test To perform an ambient air test, press the ambient test icon on the 1 page of the settings menu.

  • Page 48: Enable/Disable Bluetooth

    The result will be shown onscreen. Press the back arrow to return to the settings menu or the home icon to return to the main screen. To adjust the brightness of the display, go to the page of the settings menu and use the arrows to increase/decrease the brightness of the screen.

  • Page 49: Bluetooth Pairing

    Once Bluetooth® is enabled, the Bluetooth® symbol will no longer be crossed out on the 2 page of the settings menu and a Bluetooth® symbol will appear next to the battery status icon. Press the icon again to switch Bluetooth® off. Press the back arrow to return to the settings menu or the home icon to return to the main screen.

  • Page 50: Data Reset

    Data Reset Using the screwdriver provided with the NObreath®, unscrew the screw on the back of the device. Remove the back cover by sliding and lifting it off. To access the Data Reset button, first remove the back cover and the breath drying cartridge. This will reveal the Data Reset button at the top right of the NObreath®.
  • Page 51 Press and hold the Data Reset button for 5 seconds and the screen will reveal the reset icon. NOTE: A data reset will erase all patient data from the device the PIN will be reset to the default, 0000. Press the tick to confirm the data reset or cross to cancel.

  • Page 52: Cybersecurity

    WARNING: Any data on the NObreath® device needs to be cleared (via a reset) before returning to Bedfont® or one of its distributors for service or repair and before the unit is disposed at end-of-life. WARNING: The NObreath® needs to be stored in a secure place, e.g. a locked room or desk...

  • Page 53: Technical Specification

    Technical Specification NObreath ® device and dock Concentration range 5 – 500 ppb Display Full colour touchscreen Detection principle Electrochemical sensor ± 5 ppb of measured value ≤ 50 ppb Repeatability ± 10% of measured value > 50 ppb ± 5 ppb of measured value ≤ 50 ppb Accuracy ±...

  • Page 54: Using The Nobreath® With Fenochart

    NObreath ® mouthpiece An integrated infection control filter removes and Infection control traps > 99% of airborne bacteria and > 98% of viruses. Dimensions Approx. 180 x 25 x 15 mm (7 x 1 x 0.59 in) Weight Approx. 11 g (0.02lb) Materials Polypropylene Using the NObreath®...

  • Page 55: Troubleshooting

    Troubleshooting Possible Cause Recommended Action The sensor requires The calibration or change of the sensor and the calibrating or changing replacement of the NO and the NO scrubber scrubber is due by the date requires replacing displayed onscreen. within ≤ 30 days. This reminder will be displayed every day until it has been reset by...
  • Page 56 Possible Cause Recommended Action The calibration or The calibration or changing of the sensor and changing of the replacement of the NO sensor and scrubber was due on the replacement of the date displayed. NO scrubber is now overdue by This reminder will be ≥...
  • Page 57 During this period, testing will not be possible. This screen will clear automatically after 24 hours. Possible Cause Recommended Action There has been a Contact Bedfont® or their local sensor calibration distributor. error.
  • Page 58 Possible Cause Recommended Action There has been a Contact Bedfont® or their local verification error in distributor. the flash memory of the device. Possible Cause Recommended Action There has been an Contact Bedfont® or their local error in the distributor.
  • Page 59 Possible Cause Recommended Action There has been a Contact Bedfont® or their local database failure. distributor. Possible Cause Recommended Action The back cover of the Make sure the back of the device is device is open. secure and the turn lock is closed.
  • Page 60 Possible Cause Recommended Action No sensor detected. Ensure a sensor is inserted into the device. The sensor is not Ensure the sensor is correctly correctly inserted. inserted by pushing firmly in the top connector. Check the date & time. Change the date/time to the If this does not show current date/time and charge the the current date &...
  • Page 61 CaliBag® from Bedfont® or the local distributor, or send to the local service centre. The device may have Allow the device to rest for up to 24 been exposed to high hours in a VOC free environment.
  • Page 62 The device consistently reads 0 ppb Possible Cause Recommended Action The drying cartridge is Take the back cover off and check missing or breath drying cartridge is present disconnected. and fully located into the device. Replace the back cover. The NO scrubber is Take the back cover off and check missing or NO scrubber is present and fully...
  • Page 63 See ‘Installation and Setup’ section of this manual. The battery has been inserted incorrectly The device is not charging Contact Bedfont® or the local distributor for The battery contacts are blocked assistance. The power button is damaged There is a screen issue...

  • Page 64: Glossary Of Symbols And Safety Information

    NO NObreath® Dock is showing a Indicates a fault, overcurrent, red light undervoltage or overvoltage Contact Bedfont® or the local distributor for protection circuit has triggered assistance. Glossary of Symbols and Safety Information Glossary of Symbols Title of Symbol...
  • Page 65 Dispose of according to WEEE DO NOT THROW IN EN 50419 GENERAL RUBBISH DISPOSAL/TRASH! – Directive 2012/19/EU, Waste Electronic Annex IX Equipment Serial number Indicates the manufacturers serial ISO 15223 – 1. Clause 5.1.7 number so that a ISO 7000 – 2498 specific medical device can be identified Manufactured by...
  • Page 66 CE mark Manufacturer’s declaration of compliance to all European Directive relevant European 93/42/EEC Medical Device Regulations Bedfont® logo Manufacturer’s logo Type of protection against electric Internally shock powered equipment Degree of safety application in the Equipment not presence of a flammable...

  • Page 67: Wireless

    Wireless This device contains a Microchip Technology Inc. transmitter module: Contains Transmitter Module FCC ID: T9J-RN42 / FCC ID: A8TBM78ABCDEFGH. This is in compliance with Part 15 of the FCC Rules, Spread Spectrum Transmitter. Wireless Bluetooth® Low Energy (BLE) is used as a means of communication between the device and FeNOchart™...

  • Page 68: Emissions

    The NObreath® device should not be used adjacent to or stacked with other equipment. If • adjacent or stacked use is necessary, the NObreath® device should be observed to verify normal operation. If operation is not normal, the NObreath® or the other equipment should be moved.

  • Page 69: Immunity

    NOTE: The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services.
  • Page 70 Electromagnetic Immunity The NObreath® is intended for use in the electromagnetic environment specified below. The customer or the user of the NObreath® should assure that it is used in such an environment. Immunity Test Compliance Level Electromagnetic Environment – Guidance Conducted RF IEC 61000-4-6 3 Vrms (1 kHz 80%) 150 kHz –...

  • Page 71: Summary Of The Clinical Data

    • Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. • Consult the dealer or an experienced radio/TV technician for help. Summary of the clinical data Study 1: A clinical Precision study comparing intra and inter usability of FeNO measurement using the NObreath®.
  • Page 72 Study 2: A clinical study illustrating asthma patient response to anti-inflammatory therapy using the NObreath®. A second study also evaluated the clinical efficacy of the NObreath®; A total of 186 patients (n= 95 18+ and n=91 7 to 17 years of age) participated in a longitudinal study where measurements for FeNO, spirometry, and asthma control questionnaires were completed at baseline (Visit 1) and two weeks later (Visit 2) after therapeutic agents were administered.

  • Page 73: Analytical Performance Data

    Analytical Performance Data Linearity Four NObreath® devices were tested as part of a linearity study. 2 devices were tested in ‘adult mode and 2 devices were tested in ‘child mode’. Nitric oxide was mixed in a balance gas of air to produce NO concentration levels between <5 and >500 ppb.

  • Page 74: Interpretation Of Feno Values

    Warranty Bedfont® Scientific Limited warrants the NObreath® device and sensor to be free of defects in materials and workmanship for a period of 5 years from the date of shipment, subject to service and maintenance requirements. Bedfont®’s sole obligation under this warranty is limited to repairing or replacing, at its choice, any item covered under this warranty when such an item is returned intact and prepaid, to Bedfont®...

  • Page 75: Returns

    At the end of the product’s life, contact Bedfont® or its distributor for disposal instructions. Single-patient use consumables and accessories should be disposed of in line with local clinical waste guidelines.
  • Page 76 Email: ask@bedfont.com Web: www.bedfont.com © Bedfont® Scientific Limited 2024 Issue 20 - September 2024, Part No: LAB759_USA Bedfont® Scientific Limited reserves the right to change or update his literature without prior notice. Registered in: England and Wales. Registered No: 1289798 MD 502905...

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