Bedfont FENObreath User Manual
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Bedfont FENObreath User Manual

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  • Page 2: Important Information/Reminders

    WARNING: Ensure the patient uses a single use mouthpiece for performing a breath test. WARNING: The USB port is to be used for charging the FeNObreath™ device, this should be carried out via the supplied USB cable and also can be used for transferring encrypted patient data. The FeNObreath™...
  • Page 3 CAUTION: Portable and mobile RF communications equipment can affect the FeNObreath™. CAUTION: A great way to keep the FeNObreath™ charged when not in use is to use the docking station included. This can be connected via the pre-approved power adapter supplied, or plugged into a working USB port, to ensure the FeNObreath™...

  • Page 4: Table Of Contents

    Contents Important Information/Reminders ....................1 Introduction ..........................4 Definitions ............................. 4 Compliance ........................... 4 Intended Use ..........................4 Contraindications .......................... 5 Parts and Accessories ........................5 Instrument Layout ......................... 6 Installation and Set-up ........................7 User Interface ..........................9 Demo mode..........................10 Performing a Breath Test ......................

  • Page 5: Introduction

    The fractional NO concentration in expired breath (FeNO), can be measured by FeNObreath™ according to guidelines for NO measurement established by the American Thoracic Society. FeNObreath™ is intended for children, 7-17 years, and adults 18 years and older. FeNObreath™ 12 second test mode is for age 7 and up.

  • Page 6: Contraindications

    FeNO measurements provide the physician with means of evaluating an asthma patient's response to anti-inflammatory therapy, as an adjunct to the established clinical and laboratory assessments in asthma. The FeNObreath™ cannot be used with infants or by children under the age of 7 as measurement requires patient cooperation.

  • Page 7: 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 8: Installation And Set-Up

    ‘Parts and Accessories’ section of this manual. Please keep the screwdriver supplied for future servicing requirements. The FeNObreath™ should be charged for 4 hours prior to first use. Remove the plastic film from the display and follow the next steps on how to charge the FeNObreath™ below.
  • Page 9 When receiving power, the LED on the Dock will light up green and the FeNObreath™ can be placed in the Dock to charge. If the LED light is red, please see ‘Troubleshooting’.

  • Page 10: User Interface

    Alternatively, the FeNObreath™ FeNO monitor can be charged by plugging the micro USB cable provided directly into the FeNObreath™. This can then be connected either to the pre- approved power adapter or a computer USB port. User Interface Home Screen 1.

  • Page 11: Demo Mode

    4. Bluetooth pairing PIN 5. Go to Settings Menu Page 1 Demo mode The FeNObreath™ 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. This demo can also be used to explain to patients how the test will run, prior to performing one.
  • Page 12 Select either the adult or child patient. The zero screen will briefly display as in a real test. A demonstration will run through the breath test process.
  • Page 13 The whole test will be shown, but at an accelerated speed. 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 14: Performing A Breath Test

    Performing a Breath Test Open and insert a new mouthpiece into the FeNObreath™ monitor. 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.
  • Page 15 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 check mark onscreen indicates a successful test.

  • Page 16: Patient Profiles

    Press the retry icon to retake the test or the next arrow to view the result. Patient profiles The FeNObreath™ is designed to be capable of storing up to 25 results in up to 50 patient profiles. Press the profiles icon to access patient profiles.
  • Page 17 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 patient name or ID. 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 18 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 19 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. Delete a patient profile Select the patient that will be deleted to load their profile.

  • Page 20: Maintenance

    Maintenance FeNObreath™ - FeNO testing without limits The FeNObreath™ 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 MGC Diagnostics Corporation or the local service center.
  • Page 21 4. It is best practice to not let the battery run flat, if the FeNObreath™ indicates the battery level is on the last bar on the display, we recommend charging the device. If the FeNObreath™...

  • Page 22: 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 gray circle, , indicates the selected option.
  • Page 23 The most recent test results are automatically saved in the log and the FeNObreath™ can store 250 at a time. Use the arrow to scroll through the log. Press the back arrow to return to the settings menu or the home icon to return to the main screen.
  • Page 24 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 25 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 check mark 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 26 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 27 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 28 To perform an ambient air test, press the ambient test icon on the 1 page of the settings menu. NOTE: The ambient level of nitric oxide should be below 350ppb. The FeNObreath™ will begin sampling the atmosphere and an hourglass be shown onscreen.
  • Page 29 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 30 Bluetooth pairing To pair a device with the FeNObreath™, go to the page of the settings menu and press the Bluetooth pairing icon. The screen will display the Bluetooth pairing PIN.

  • Page 31: Data Reset

    Data Reset Using the screwdriver provided with the FeNObreath™, unscrew the screw on the back of the monitor. 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.
  • Page 32 Press the tick to confirm the data reset or cross to cancel. An hourglass will display onscreen as the FeNObreath™ begins erasing all data. NOTE: This can take up to 5 minutes to complete. Once complete, the screen will prompt for the back cover to be replaced.

  • Page 33: Quality Check And Calibration

    Quality Check and Calibration The FeNObreath™ will allow a 2-step quality check to be performed, this should be performed within 6 months before an annual calibration, or more frequently if required. This is to ensure the FeNObreath™ is within specification. The 2-step quality check will be carried out using filtered ambient air and 100ppb Nitric Oxide (Quality Check Bag).
  • Page 34 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 FeNObreath™. Turn on the FeNObreath™.
  • Page 35 Insert the other end of the CaliAdapter into the FeNObreath™. Press the Settings icon. Press the Ambient Test icon. An hourglass will appear onscreen while the FeNObreath™ performs the Quality Check without gas.
  • Page 36 Quality Check with gas. If the NO reading is >5ppb, please follow the next steps on replacing the NO scrubber and performing a Quality Check with gas. Remove the Bung from the FeNObreath™. Press the Home icon to return to the home screen.
  • Page 37 How to replace the NO Scrubber Please ensure the FeNObreath™ monitor is switched off before removing the back cover. Using the screwdriver provided with the FeNObreath™, unscrew the screw on the back of the monitor. Remove the back cover by sliding and lifting it off.
  • Page 38 Please ensure the CaliAdapter and Scrubber Adapter have been removed from the scrubber before inserting into the FeNObreath™. Re-attach the back cover of the FeNObreath™ monitor. To secure the FeNObreath™ back cover in place, use the screwdriver to rescrew the screw into place.
  • Page 39 NO gas which will be close to, but may not be exactly, 100ppb. Insert the Bag Adapter into the Quality Check Bag. Insert the Bung into the bottom vent hole on the back of the FeNObreath™.
  • Page 40 Turn on the FeNObreath™. With the Quality Check Bag attached, insert the CaliAdapter into the FeNObreath™. Press the Settings icon. Press the Ambient Test icon.
  • Page 41 When an hourglass appears, open the clamp while the FeNObreath™ 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...

  • Page 42: Calibration Using A Calibag

    Remove the Bung from the FeNObreath™. Press the Home icon to return to the home screen. If the reading is not within the specification of the concentration range, one of the following should be carried out: 1. Calibrate using a CaliBag®...
  • Page 43 Ensure both Bag Clamps on the CaliBag® are closed and remove a Blue Plug from one end. Insert the Bag Adapter into the CaliBag®. Insert the Bung into the bottom vent hole on the back of the FeNObreath™ and turn the device on.
  • Page 44 NO concentration written on the CaliBag®. Press the arrow icon twice to continue. With the CaliBag® attached, insert the CaliAdapter into the FeNObreath™. Press the next arrow once to continue. NOTE: Make sure the calibration gas CaliBag® is being used.
  • Page 45 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®. A successful calibration is shown by a green check mark. Press save to complete the calibration.

  • Page 46: Cybersecurity

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

  • Page 47: Technical Specification

    Technical Specification FeNObreath™ monitor and Dock Concentration range 5-500ppb Display Full colour touchscreen Detection principle Electrochemical sensor ±5ppb of measured value ≤ 50ppb Repeatability ±10% of measured value > 50ppb ±5ppb of measured value ≤ 50ppb Accuracy ±10% of measured value > 50ppb 1 x main rechargeable Li-ion battery –...

  • Page 48: Buttons Explained

    FeNObreath™ 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. 11g (0.02lb) Materials Polypropylene...

  • Page 49: Troubleshooting

    Troubleshooting Possible Cause Recommended Action The service date is This will be displayed every day until 365 days has due in ≤30 days. surpassed or it has been reset by performing a calibration or sensor change. Possible Cause Recommended Action 365 days has This will be displayed every day until it has been reset...
  • Page 50 Possible Cause Recommended Action The back cover of Make sure the back of the the device is open device is secure and the turn lock is closed. The back cover Take the back cover off, button is check the back cover button damaged, lost or is present.
  • Page 51 Possible Cause Recommended Action The device battery is Place the monitor in the flat/empty charging dock and plug into a power source. Alternatively, plug the device directly into a power source. See ‘Installation and Setup’ section of this manual. Possible Cause Recommended Action The device may be out If the user suspects the device...
  • Page 52 The device consistently reads 0ppb Possible Recommended Cause Action The drying Take the back cartridge is cover off and missing or check drying disconnected cartridge is present and fully located into the device. Replace the back cover. The NO Take the back scrubber is cover off and missing or...
  • Page 53 Notification Issue Possible Cause Recommended Action The device will not switch on The battery is missing Take the back cover off, check battery is present and fully located into the device. Replace back cover The battery is flat Place the monitor in the charging dock and plug into a power source.

  • Page 54: Glossary Of Symbols And Safety Information

    This is from the scrubber material This is not an issue. Scrubber has potassium permanganate and charcoal buds inside the device to scrub ambient NO FeNObreath™ Dock is Indicates a fault, overcurrent, showing a red light undervoltage or overvoltage Contact MGC Diagnostics Corporation or the local protection circuit has triggered distributor for assistance.
  • Page 55 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 56: Wireless

    Wireless Bluetooth Low Energy (BLE) is used as a means of communication between the monitor and FeNOchart™ software running on a PC. The FeNOchart™ software is a charting program that retrospectively collects data from the FeNObreath™ monitor when it is not monitoring. It is not time critical, there are no alarms.
  • Page 57 The USB port is to be used for charging the FeNObreath™ device, this should be carried out via the supplied USB lead and also can be used for transferring encrypted patient data. The FeNObreath™ is not intended to be connected to any wireless adaptors or any other USB Host.

  • Page 58: Emissions

    Immunity Guidance and manufacturer’s declaration: Electromagnetic immunity The FeNObreath™ is intended for use in the electromagnetic environment specified below. The customer or the user of the FeNObreath™ should ensure that it is used in such an environment. Immunity test...
  • Page 59 IEC 61000-4-8 environment. Electromagnetic Immunity The FeNObreath™ is intended for use in the electromagnetic environment specified below. The customer or the user of the FeNObreath™ should assure that it is used in such an environment. Immunity Test Compliance Level Electromagnetic Environment –...

  • Page 60: Summary Of The Clinical Data

    Study 1: A clinical Precision study comparing intra and inter usability of FeNO measurement using the FeNObreath™. In one of the studies conducted, the clinical precision, as it relates to user bias of the FeNObreath™, was evaluated in a mixed study population of 76 participants - including 24 pediatric participants (ages 7-17 years) and 52 adults (18 years+).
  • Page 61 For those with elevated initial FeNO defined by ATS >25ppb for adults and >20ppb for children (total n=139),there was a fall in mean FeNO measured by FeNObreath™ in patients with elevated FeNO levels for combined adult and pediatric treatment population (n=139).

  • Page 62: Analytical Performance Data

    Analytical Performance Data Linearity Four FeNObreath™ 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 63: Interpretation Of Feno Values

    Warranty MGC Diagnostics Corporation warrants the FeNObreath™ monitor 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. MGC Diagnostics Corporation’s sole obligation under this warranty is...

  • Page 64: Returns

    Please contact MGC Diagnostics Corporation or its local distributor for instructions on returning goods. Responsible Manufacturer and Contacts Distributed by: MGC Diagnostics Corporation 350 Oak Grove Pkwy Manufactured by Bedfont® Scientific Ltd. Saint Paul, MN, USA 55127 Station Yard, Station Road, 651-484-4874 Harrietsham, www.mgcdiagnostics.com Maidstone, Kent, info@mgcdiagnostics.com...

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