Bedfont NObreath FeNO User Manual
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Bedfont NObreath FeNO User Manual

Breath monitor
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NObreath
®
FeNO Breath Monitor
User Manual
0086
Aids in the diagnosis & management of asthma,
one breath at a time.

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Summary of Contents for Bedfont NObreath FeNO

  • Page 1 NObreath ® FeNO Breath Monitor User Manual 0086 Aids in the diagnosis & management of asthma, one breath at a time.

  • Page 2: Important Information/Reminders

    Important Information/Reminders NOTE: The NObreath® should be charged for a minimum of 4 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. WARNING: Please read the manual before use. WARNING: Never use alcohol or cleaning agents containing alcohol or other organic solvents as these vapours will damage the electrochemical sensor inside. WARNING: Under no circumstances should the instrument be immersed or splashed with liquid. WARNING: Breath tests must only be carried out with Bedfont accessories. Failure to do so may cause incorrect readings. WARNING: The mouthpieces are single patient use only and can be used for a maximum of 3 tests. Further re-use could cause incorrect readings and could increase the risk of cross infection. The mouthpiece should be disposed of after use, in accordance with local waste disposal guidance. WARNING: Patients should exhale for the duration of time indicated by the monitor during a breath test. Failure to do so may cause incorrect readings. WARNING: To ensure a breath sample is taken at the correct flow rate, the monitor must be held upright at all times during a breath test. WARNING: Do not block the exhaust ports on the device at any time. Blocking the exhaust ports may cause erroneous readings. CAUTION: Ensure the monitor is used within the stated operating temperature and humidity ranges. Operating temperature is 15-35 C. Operating humidity is 25-80% RH (non-condensing). CAUTION: Portable and mobile RF communications equipment can affect the NObreath®. CAUTION: It is best practice to keep the NObreath® battery at 2 blocks charged. Do not keep the NObreath on charge 24/7. Do not let the NObreath® battery run flat. NOTE: See Bedfont’s infection control and maintenance guidelines for further information on infection control. NOTE: Please do not attempt to modify the equipment in any way or use accessories not specified by the manufacturer. Any attempt to do so, will invalidate the warranty and may compromise the safety of the device. NOTE: Bedfont® will make available on request service training to appropriately qualified personnel.

  • Page 3: Table Of Contents

    Contents Important Information/Reminders .................... 1 Introduction ............................ 3 Definitions ............................ 3 Compliance ............................ 3 Intended Use ............................ 3 Contraindications .......................... 3 Instrument Layout .......................... 4 Installation and Set-up ........................ 5 User Interface ............................. 5 Demo mode ............................ 8 Performing a Breath Test ......................... 1 Patient profiles .......................... 1 Maintenance ............................ 2 Settings ............................. 2 Data Reset ............................ 3 Technical Specification ........................ 3 Using the NObreath® with FeNOchart™ .

  • Page 4: Introduction

    Introduction The User Manual provides instructions on how to operate NObreath® FeNO monitor and its accessories. It contains relevant information about the monitor, its uses and its care, including step- by-step instructions with screens and illustrations. Definitions WARNING: indicates a potentially hazardous situation, which, if not avoided, may result minor or moderate injury. CAUTION: indicates a potentially hazardous situation, which, if not avoided, may result in damage to the device. NOTE: used to call attention to notable information that should be followed during use. Compliance NObreath® is CE marked according to the Medical Device Directive 93/42/EEC. Please refer to the ‘Safety Information’ section of this manual for more information on the compliance of the NObreath®. Intended Use The NObreath® is a breath nitric oxide (NO) test system intended to measure fractional exhaled nitric oxide (FeNO) in parts per billion (ppb) in exhaled breath. The measurement is taken to evaluate airway inflammation and should be used in conjunction with other clinical and laboratory evaluations where appropriate when making a diagnosis or treatment plan. The measurements are intended for interpretation by healthcare professionals and for use in a healthcare environment, where patients will complete measurements under supervision. Contraindications There are no known contraindications.

  • Page 5: Instrument Layout

    Instrument Layout 1. ON/OFF switch 5. Manufacturer label 2. Touchscreen 6. Exhaust port 3. Mouthpiece aperture 7. Serial label 4. ¼ turn lock 8. Exhuast port...

  • Page 6: Installation And Set-Up

    Installation and Set-up NOTE: The NObreath® should not be operated in an environment outside of the temperature or humidity ranges stated in the technical specification. The NObreath® should be charged for 4 hours prior to first use. The default PIN is 0000. It is strongly recommended to change this prior to first use – please refer to the ‘Change PIN’ section of this manual for instructions. 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...
  • Page 7 The information screen displays information about the monitor and sensor. Settings Menu Page 1 1. Date and time options 2. Test log 3. Change PIN number 4. Enable/disable PIN use 5. Change flow-meter style 6. Start ambient air test 7. Service Area 8. Home button 9. Go to Settings Menu Page 2 NOTE: The Service Area must only be accessed by trained personnel.
  • Page 8 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...

  • Page 9: Demo Mode

    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. This demo can also be used to explain to patients how the test will run, prior to performing one. Press the demo icon to begin. Select either the adult or child patient.
  • Page 10 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 11 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 12: Performing A Breath Test

    Performing a Breath Test Open and insert a new mouthpiece into the NObreath® monitor. To start a breath test, select either the adult or child patient. As prompted onscreen, take a deep breath. NOTE: Do not inhale through the mouthpiece. Press the home button at any time to cancel the breath test. When the exhale icon displays, keep the monitor upright and blow gently into the mouthpiece. NOTE: Make sure the vent holes are not covered. The exhalation time is approximately 12 seconds for an adult and 10 for a child.
  • Page 13 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 14: Patient Profiles 1

    The results will then be shown onscreen in ppb. Return to the home screen by pressing the home button or save the result to a patient profile. If the patient exhales outside of the exhalation guidelines, the test will beep before indicating a fail and a red cross will appear. Press the retry icon to retake the test or the next arrow to view the result.

  • Page 15: Patient Profiles

    Patient profiles The NObreath® is designed to be capable of storing results in up to 50 patient profiles Press the profiles icon to access 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 16 A list of patient profiles will show onscreen. Create a new patient profile To create a new profile, choose an empty name slot.
  • Page 17 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. 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. Return to the main screen...
  • Page 18 Once an adult or child breath test has been selected, the profile will only offer that breath test mode in future. Edit a patient profile To edit a patient’s profile, select their name/ID from the list.
  • 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 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 21: Maintenance

    Maintenance ® Lifetime of a NObreath The NObreath has unlimited uses. Subject to correct use, maintenance and service. Tested up to 30,000 tests. Routine maintenance 1. Mouthpieces are to be replaced after every patient. 2. Hands should be washed regularly in accordance with infection control practice. CAUTION: Do not use sanitising products containing alcohol as this may damage the sensors. 3. Only use accessories approved by Bedfont®. CAUTION: Use of accessories not approved by the manufacturer will invalidate the warranty and may compromise the safety of the device. 4. It is best practice to not let the battery run flat. If this occurs, the device may need calibration. Please contact Bedfont or its local distributor for advice. Servicing 1. The NObreath® should be calibrated annually or the NO sensor should be replaced. 2. The NO scrubber should be replaced annually. 3. The NO sensor, breath drying cartridge and the pump should be replaced every 5 years WARNING: Do not open the NObreath® device. This could result in bodily harm and a void in warranty. Servicing should only be carried out by a Bedfont® trained representative. Cleaning Bedfont® recommends wiping the instrument’s external surfaces with a product specifically developed for this purpose. Bedfont® provides instrument cleaning wipes. The device or consumables cannot be sterilised. It is recommended that wipes are used once and for one surface only. The NObreath® device should be cleaned for initial use and after each patient use. CAUTION: Do not use any substances containing alcohol on or near the NObreath®. Under no circumstances should the instrument be immersed in liquid or splashed with liquid.

  • 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 purple circle, , indicates the selected option. To adjust the date/time, select the number and it will become highlighted. Use the arrows to change as desired. Press the save button to keep the changes. To cancel, press the back arrow to return to the settings menu.
  • Page 23 Test log To access the test log, press the log icon on the 1st page of the settings menu. The most recent test results are automatically saved in the log and the NObreath can store 150 at a time. Use the arrows 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 Change PIN Each device is pre-set to the PIN code 0000. It is highly recommended that the PIN is changed to a memorable 4 digit number. 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 25 Enter the current PIN and press the next arrow to proceed. A prompt will then ask for a new PIN number to be entered.
  • Page 26 Enter a new memorable 4 digit code and press the next arrow to continue A prompt will ask for the new PIN number to be re-entered for confirmation.
  • Page 27 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. Enable/disable PIN To disable the PIN, press the enable/disable PIN icon on the 1 page of the settings menu.
  • Page 28 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 29 Change flow-meter style To change the flow-meter style, press the flow- meter button on the 1 page of the settings menu. Select either the adult or child test mode to change the flow-meter style.
  • Page 30 The current flow-meter style will be highlighted. Select the new style and press the save icon to register.
  • Page 31 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 32 The NObreath® will begin sampling the atmosphere and an hourglass be shown onscreen. 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.
  • Page 33 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. Enable/disable Bluetooth To enable Bluetooth, go to the 2 page of the settings menu and press the enable/disable Bluetooth button.
  • Page 34 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. Bluetooth pairing To pair a device with the NObreath®, go to the 2 page of the settings menu and press the Bluetooth pairing icon.
  • Page 35 The screen will display the Bluetooth pairing PIN. Please make sure the Bluetooth on the NObreath® and the other device is switched on in order to pair with the NObreath®. Press the back arrow to return to the settings menu or the home icon to return to the main screen.

  • Page 36: Data Reset

    Data Reset 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®. 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 37 An egg timer will display onscreen as the NObreath® begins erasing all data. NOTE: This can take up to 5 minutes to complete. Once complete, the screen will prompt you to add the back cover again. Ensure that you have re-inserted the breath drying cartridge and then reattach the back cover.
  • Page 38 All data will be erased and the home screen will display once more.

  • Page 39: Technical Specification

    Technical Specification ® NObreath monitor and dock Concentration range 0-500ppb 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 – Approx. 100 uses on fully charged battery NObreath® monitor 2 x Li-ion coin cell battery – Approx. 5 years Input: 5V, 0.5A Power Mains powered NObreath® Dock Input: 5V, 0.5A Output: 5V, 0.5A Input: 100-240V ~ 50/60Hz., 0.2A Plug Output: 5.0V, 1.0A response time ≤10 seconds Operating 15-35 Temperature Storage/transport 0-50°C Operating 25-80% RH (non-condensing) Humidity Storage/transport 5-95% RH (non-condensing) Operating/transport/storage pressure Atmospheric ±10%...

  • Page 40: Using The Nobreath® With Fenochart

    Using the NObreath® with FeNOchart™ The NObreath® monitor is supplied with FeNOchart™ software, which allows patient data to be synchronised from the device to a computer, where results can be safely stored and analysed. FeNOchart™ can be downloaded directly from www.nobreathfeno.com. Insert the USB lead into the PC, and connect the other end to the rear of the docking station. Place the NObreath® into the docking station, connecting it to the micro USB in the base. Alternatively, the micro USB lead can be directly connected to the base of the NObreath® unit itself. Before starting the software, ensure that the NObreath® is connected to the PC and switched on. Double click the FeNOchart ™ icon on the PC to start the programme. Refer to the FeNOchart ™ manual for how to operate the FeNOchart ™ software. Buttons Explained Information Retry Change PIN Adult test Save Disable PIN Child test Next screen Enable PIN Change flow meter Demo mode Previous screen style Patient profiles Settings Ambient test Home button Date & time Disable Bluetooth Graph of results Selected Enable Bluetooth Service Area Delete patient Increase (See service manual) Confirm Decrease Cancel Test log...

  • Page 41: Troubleshooting

    Troubleshooting The service date is due in ≤ 30 days. This will be displayed every day until it has been reset by performing a calibration or sensor change. 365 days has elapsed since the last service. This will be displayed every day until 395 days has surpassed or it has been reset by performing a calibration or sensor change. 395 days has elapsed since the last service. This will be displayed every day until it has been reset by performing a calibration or sensor change. No tests can be performed until the monitor has been serviced.
  • Page 42 The back of the monitor is open. Make sure the back of the unit is secure and the ¼ turn lock is closed to continue. No sensor detected. Verify the sensor is correctly inserted to continue. The battery is flat. Place the monitor in the charging dock or connect directly to the mains. The NObreath® takes 8 hours to charge fully.

  • Page 43: Safety Information

    Safety Information Degree of protection against electric shock Type BF applied part Type of protection against electric shock Internally powered equipment Degree of protection against ingress of liquid IPX0 – not protected against water ingress Degree of safety application in the presence of a Equipment not suitable for use in the presence of flammable anaesthetic mixture with air, oxygen or flammable mixtures. nitrous oxide Refer to manual The device includes a Radio Frequency (RF) transmitter (Bluetooth) CE mark Direct current Dispose of according to WEEE Serial number Manufactured by Manufacture date Bedfont® logo...
  • Page 44 Electromagnetic Immunity The NObreath® and NObreath® Dock comply with the directive EN60601-1-2:2015 4th edition electromagnetic compatibility. Guidance and manufacturer’s declaration: Electromagnetic immunity The NObreath® is intended for use in the electromagnetic environment specified below. The customer or the user of the NObreath® should ensure that it is used in such an environment. Electromagnetic environment Immunity test IEC 60601 test level Compliance level guidance Floor should be wood, concrete or Electrostatic ceramic floor tile. If floors are ±8kV contact ±8kV contact Discharge (ESD) covered with synthetic material the ±15kV air ±15kV air IEC 61000-4-2 relative humidity should be at least 30%. Electrical fast transient/burst – – – IEC 61000-4-5 Surge – – – IEC61000-4-5 Voltage dips, short interruptions and voltage – – –...

  • Page 45: Parts And Accessories

    Parts and accessories Quick Start 1. NObreath® Dock 7. Microfiber cloth 2. USB cable 8. Quick Start Guide 3. Mains plug and universal adaptors 9. Screwdriver 4. NObreath® Forum information 10. Infection Control Maintenance Guidelines 5. Interpretation chart 11. Patient Preparation 6. NObreath® mouthpiece...

  • Page 46: Warranty

    Warranty Bedfont® Scientific Limited warrants the NObreath® monitor, sensors and batteries excepted, to be free of defects in materials and workmanship for a period of 2 years from the date of shipment, subject to service and maintenance requirements. The NO sensor is guaranteed for a period of 6 months only from the date of shipment from Bedfont®. 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® or the local representative. This warranty is automatically invalidated if the products are altered or tampered with by unauthorised personnel, or have been subject to misuse, neglect or accident. At the end of the product’s life, contact Bedfont® or its distributor for disposal instructions. Single use consumables and accessories should be disposed of in line with local clinical waste guidelines. Never dispose of any electronic instrument or batteries in domestic waste. At the end of the product’s life, contact Bedfont® or its distributor for disposal instructions. Returns Please contact Bedfont® or its local distributor for instructions on returning goods. Responsible Manufacturer and Contacts Bedfont Scientific Ltd. www.bedfont.com Station Yard, Station Road, www.nobreathfeno.com Harrietsham, Maidstone, Kent, ask@bedfont.com ME17 1JA 0044 1622 851122 United Kingdom...
  • Page 47 Tel: +44 (0)1622 851122 Fax: +44 (0)1622 854860 Email: ask@bedfont.com www.bedfont.com © Bedfont® Scientific Limited 2019 Issue 5- January 2019, Part No: LAB759 Bedfont® Scientific Limited reserves the right to change or update this literature without prior notice. Registered in: England and Wales. Registered No: 1289798...

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