Do you have a question about the NObreath and is the answer not in the manual?
Questions and answers
Светлана
May 5, 2025
Монитор не включается, прибор перед этим 1.5 года не использовался.
1 comments:
Mr. Anderson
May 18, 2025
The Bedfont NObreath monitor may not be turning on after 1.5 years of inactivity because the batteries may be discharged or have leaked. The manual recommends ensuring the battery is charged prior to use and checking for battery leakage after extended periods of non-use.
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. Introduction The production of nitric oxide is often found to be higher in inflammatory conditions such as asthma and can therefore be used for the detection and management of such conditions . Nitric oxide measurement is not intended as a stand-alone method for diagnosis and should be used in conjunction with other evaluation methods and tests Product description The NObreath® is a hand-held breath nitric oxide monitor supplied with the NObreath® Dock, and FeNOCHART™ software. The measurement system uses electrochemical sensor technology, which has been specifically designed for this purpose. The sensor reacts to the presence of nitric oxide producing an electrical output, which is then amplified with the result displayed. The sensor has ambient air flowing into the sensor chamber while the unit is on, but not performing a breath test. The sample system for the NObreath® has been specifically designed in order to meet the breath test guidelines described in the ATS/ERS Recommendations. The ATS/ERS Recommendations are standardized procedures for the online and offline measurement of exhaled upper respiratory nitric oxide and nasal nitric oxide The patient shall exhale at 50ml/sec, using the on screen flow indicator through the sample system, into the instrument, until a reading is displayed. The NObreath® shall also have the capability to perform an ambient air test as required. Bedfont® privacy statement: This product stores the personal information of patients and measurement data. It is the sole obligation of the healthcare professional to make sure this information is secure and compliant with your relevant data protection regulations.
Warnings Read the manual before use. • NEVER use alcohol or cleaning agents containing alcohol or other organic solvents as • these vapours will damage the electrochemical sensor inside. Under NO circumstances should the instrument be immersed or splashed with liquid. • Ensure the unit is properly charged before taking a breath test. • Breath tests must ONLY be carried out with the correct Bedfont® accessories. Failure to • do so will cause incorrect readings and may invalidate your warranty. The vent holes on the rear of the unit must NEVER be covered during normal use. • Covering the vent holes may cause incorrect readings. DO NOT attempt to modify the equipment in any way. Any attempt to do so will • immediately invalidate your warranty, cause incorrect readings, and may compromise the safety of the device. DO NOT leave the NObreath® or docking station in direct sunlight. • It is best practice to NOT let the battery run dead. • Cautions Ensure the monitor is used within the correct temperature and relative humidity (RH) • range, as stated in the specification on page 4. The NObreath® complies with the EMC requirements of IEC 60601-1-2, outside of these • requirements portable and mobile RF communications equipment may affect the device. Federal law restricts the device to sale only by, or on the order of, a physician (USA only) • NObreath® Mouthpiece technical specification A one-way valve to prevent patients drawing air back from the monitor. Infection control An integrated infection control filter removes and traps >99% of airborne bacteria and >96% of viruses Dimensions Approx. 180 x 25 x 15 mm...
NObreath® and NObreath® Dock technical specification Exhaled flow during FeNO measurement at 50ml/sec ±10% at 10cm H 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 10-30°C Temperature Storage/transport 0-40°C Operating 25-75% non-condensing Humidity Storage/transport 0-95% non-condensing Operating/transport/storage pressure Atmospheric ±10%...
Safety information and device symbols 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 IPXO – not protected against water ingress Degree of safety application in the presence of Equipment not suitable for use in the presence a flammable anaesthetic mixture with air, of flammable mixtures. oxygen or 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...
Environment The NObreath® and NObreath® Dock comply with the directive EN60601-1-2:2015 4 edition electromagnetic compatibility. Electromagnetic immunity: The NObreath® and NObreath® Dock comply with the directive EN60601-1-2 electromagnetic compatibility but can be affected by cellular phones and by electromagnetic interference exceeding the levels specified in EN55011:2007 Class B. 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,...
Instrument layout 1. ON/OFF button 2. Touchscreen display 3. Mouthpiece aperture 4. Vent holes 5. Service cover lock 6. Micro USB port 7. NObreath® Dock (applied part) 8. USB cable (applied part) 9. NObreath® single-use mouthpiece 10. Mains power adaptor with connectors...
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Inside the service cover: 11. Rechargeable Li-ion battery 12. Breath drying cartridge 13. Ambient air NO scrubber 14. NO electrochemical sensor...
Display symbols Device information Save Adult breath test Home screen Child breath test Next screen Demo mode Previous screen Patient profiles Patient results (PIN protected) Battery (full) Delete patient Battery (half) Settings Battery (critical) Date/time Selected Inhale (adult) Unselected Exhale (adult) Increase Inhale (child) Decrease Exhale (child) Test log Pass Change PIN Fail Disable PIN Retry Enable PIN Set measurement incentive Diagnostics preference...
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Ambient mode Diagnostics log Screen brightness Sensor Disable Bluetooth Maintenance due reminder Maintenance overdue Enable Bluetooth reminder Maintenance overdue Bluetooth PIN locked reminder Bluetooth enabled display Rear cover off Service access No sensor warning No scrubber cartridge Pump calibration warning Refer to manual Reset Gas calibration Ambient mode locked Temperature too low to Adult breath test locked calibrate...
Temperature too high to Child breath test locked calibrate Sensor zeroing Charging Confirm Cancel Demo mode The NObreath® has an in-built demonstration video of the breath test process. We recommend watching 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. 1. The demo video can be accessed from the home screen by pressing the icon. 2. Select either the or icon. 3. A demonstration will run through the breath test process. The whole test will be shown, but at an accelerated speed. Performing a breath test 1. Turn the NObreath® monitor ON by pressing the power button, once. 2. Open a new NObreath® mouthpiece and insert it into the front of the unit. 3. To start a breath test, touch the or icon on the screen. NOTE: To cancel the breath test, press the icon. 4. As prompted onscreen by or , inhale until prompted to exhale. Do not inhale through the mouthpiece.
5. When directed to do so by either or , keep the monitor upright and blow gently into the mouthpiece. Make sure you are not covering the vent holes. NOTE: The exhalation time is approximately 12 seconds for an adult and 10 for a child. 6. The onscreen flow meter will guide you on the exhalation rate: continue blowing until the green tick appears on screen to indicate a successful test. NOTE: If you outside of the exhalation guidelines, the test will beep, before indicating a fail, and a red cross will appear. Touch to retry the test or to view the result. 7. Following the tick, a result will appear on the screen, in ppb. 8. You may save this result by pressing NOTE: If you have not entered your PIN in the last 30 minutes, you will be asked to enter it before you can access the patient profiles. If your PIN is entered incorrectly, you will be notified and the screen will refresh for you to re-enter your PIN. If you have forgotten your PIN, please contact Bedfont® or your local distributor to reset it. 9. Alternatively, you can return to the home screen by pressing Patient profiles The NObreath® is designed to be capable of storing results in up to 50 patient profiles. From the home screen, select the icon to access patient profiles. If you have not entered your PIN in the last 30 minutes, you will be asked to enter it before you can access the patient profiles. Enter your 4 digit PIN and if successful you will be presented with a list. If your PIN is entered incorrectly, you will be notified and the screen will refresh for you to re-enter your PIN. If you have forgotten your PIN, please contact Bedfont® or your local distributor to reset it. To create a new patient profile To create a new profile, choose an empty profile box and enter a name or reference. Then press Alternatively - press a profile name to open it.
Take a breath test To take a test directly from a patient’s profile, open the profile and select either the ADULT or CHILD icons and follow the on-screen instructions. NOTE: once an has been selected from a patient’s profile screen, the profile will ONLY display the option you selected from then onwards. View the results When in a patient’s profile, you can press the icon to show a graphical representation of all the tests saved to that profile. Each point on the graph shows the numerical reading, and the date/time at which it was logged. Edit a profile To edit a patient’s profile, select their name/ID from the list and then press their name/ID again. Edit as desired using the keypad and either touch to keep the changes or to cancel. Delete a profile Select the patient you wish to delete from the list and press the icon. Press the tick to confirm. The profile will be deleted and you will be returned to the profile screen. Device information For information on the device, the current version of software, serial number and calibration date, touch the icon in the top left corner of the home screen.
Change the date/time Press and then to access the date/time menu. You can then select either d-m-y or m-d- y for the date format and 12h or 24h for the time format. To adjust the date/time, select the number you wish to change and pressing or to increase/decrease. Press to save your settings or to abort changes and return the previous screen. Press to return to the main screen. Test log A log of the most recent 150 test results are saved automatically in the log. To view the log, press then the icon and scroll through using the arrows. Press to return the previous screen or to return to the main screen. Change PIN 1. Each device will automatically be pre-set to the PIN code 0000. It is highly recommended that you change this PIN to a 4 digit number that you will remember. 2. To change the PIN, press the change PIN icon from the settings menu and you will prompted to enter the current PIN. NOTE: If your PIN is entered incorrectly, you will be notified and the screen will refresh for you to re-enter your PIN. If you have forgotten your PIN, please contact Bedfont® or your local distributor to reset it. 3. Enter the 4 digit code and press to continue 4. Enter a new memorable 4 digit PIN and press to continue 5. Re-enter your PIN to confirm the new 4 digit code and press the tick to register...
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6. If at any point you change your mind, press to return the previous screen or to return to the main screen. Disable/enable PIN For data security reasons, the list of patient profiles on the NObreath® FeNO monitor is PIN protected and you are required to enter a 4 digit code after switch-on and every 30 minutes thereafter for optimum security. Although it is not recommended, there is the option disable/enable the PIN from the settings menu. If the PIN is enabled, press and enter your 4 digit code to disable it. If the PIN is disabled, press and enter your 4 digit code to enable it. NOTE: If your PIN is entered incorrectly, you will be notified and the screen will refresh for you to re- enter your PIN. If you have forgotten your PIN, please contact Bedfont® or your local distributor to reset it. Change the flow-meter display To change the flow-meter display, touch the icon in the settings menu. You will be shown which meters are currently set for both the Adult and Child settings. Touch each to be shown other flow-meter options. Choose a flow-meter display and press to save the changes. If you do not wish to change the flow-meter display, simply select save to keep the current option. Press to return the previous screen or to return to the main screen. Ambient testing To conduct an ambient air test, touch the icon. A test will begin automatically and a timer will be shown onscreen. When the test is complete, a result will be displayed. This is important as...
Press to return the previous screen or to return to the main screen. Screen brightness To adjust the brightness of the display, once in the settings menu, press to access the second page where you will find the brightness settings . Use the arrows or to increase/decrease the brightness of the display. Press to return the previous screen or to return to the main screen. Bluetooth To turn Bluetooth ON/OFF, once in the settings menu, press to access the second page and then press or to toggle Bluetooth ON or OFF. If Bluetooth is enabled, the Bluetooth icon will be visible at the top left-hand of the monitor, next to the battery symbol . To pair another Bluetooth enabled device with the NObreath®, select the Bluetooth PIN icon to show the pairing PIN onscreen. Press to return the previous screen or to return to the main screen. Maintenance The NObreath® should be calibrated at least annually or the NO sensor should be replaced. • The breath drying cartridge and NO scrubber should be replaced annually. • NOTE: The unit is designed to provide maintenance reminders when re-calibration is required. You will be prompted to service the unit when necessary. The NO sensor and pump should be replaced every 5 years • The maintenance reminder screen shall be displayed at switch-on if the service • date is due in ≤ 30 days & displayed every day until it has been reset by performing a...
The maintenance overdue reminder screen shall be displayed at switch-on if a • required service has elapsed 365 days since the last service & displayed every day until it has been reset by performing a calibration or sensor change. The maintenance overdue reminder screen shall be displayed at switch-on if a • required service has elapsed 395 days since the last service & displayed every day until it has been reset by performing a calibration or sensor change. Each mouthpiece is single-patient use, and must be disposed of after each test • Never open the unit without prior training from Bedfont® or an authorized representative. • Doing so will invalidate the warranty and may impair the performance of the unit Bedfont® will make available upon request any additional technical information, and service • training, to appropriately qualified persons Service settings The service menu can be accessed from the settings menu by pressing the service access icon from the settings menu. Pump calibration To calibrate the pump, click on the and follow the instructions below: 1. Connect the flow meter to the mouthpiece aperture and block the bottom vent hole. 2. Use the arrows onscreen, or , to increase/decrease the flow rate until the flow meter reads 350 mL/min. 3. Press to save the pump calibration or to cancel and return to the previous screen. 4. Return to the home screen by pressing Gas calibration...
To calibrate the NObreath®, follow the steps below to complete calibration: NOTE: 200ppb NO gas, a flow meter that is set or can be adjusted to 1 litres per minute (L/pm) and a device temperature of 21°C ±4°C (68°F ±39°F) is required to complete this task. 1. In the server settings menu, start the calibration process by pressing 2. The device will perform a zero indicated by : do not apply gas at this stage 3. Follow the onscreen instructions to finish the calibration process 4. Gas flow should be set to 1 L/pm 5. A successful calibration will be indicated by the . Press to save the calibration. NOTE: If you click on the home icon before confirming the calibration, it will be dismissed and you will have to repeat the calibration. 6. A failed calibration will be indicated by . Press to attempt calibration again. If the problem persists see ‘Troubleshooting’ or call your local supplier of Bedfont® products. 7. Return to the home screen by pressing View device diagnostics To access the diagnostics information screen, press the icon followed by the icon. From here you can also see the diagnostics log by pressing the icon. This will list all the service dates and times alongside their success or failure as indicated by the tick/cross. Press to return to the previous screen or to return to the main screen. Sensor replacement To replace the NObreath® sensor, click on the icon in the service settings and then refer to ‘Service access section of this manual. Servicing NOTE: Before undertaking any of the actions below, please make sure that the device is switched off.
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Accessing the serviceable components of the NObreath® Using the screwdriver provided with the NObreath®, turn the quarter-turn lock anti-clockwise to open and slide and lift off the back cover. Breath drying cartridge replacement Grip the breath drying cartridge as shown below and tug lightly until you hear a click. Then, simply lift the cartridge out and replace by sliding a new one into place. NO scrubber replacement As shown below, press down on clip on the left-hand side of the monitor and slide out the NO scrubber then lift to remove and replace with a new one.
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Battery removal/replacement Remove the breath drying cartridge to access the battery. Using the groove, pull the battery out towards you, as demonstrated below, and replace. Sensor replacement 1. Using your thumb and forefinger, lift the tab on the sensor and apply pressure to the top and pull directly up to gently lift the sensor up and out. 2. Replace by slotting the new sensor in. 3. Reassemble the NObreath® and switch the device back on.
4. Press to continue. 5. A successful replacement will be indicated by the . A failed replacement will be indicated by . Press to re-attempt. If the problem persists see ‘Troubleshooting’ or call your local supplier of Bedfont® products. Factory reset To access the factory reset button, remove the breath drying cartridge to reveal the button at the top right of the NObreath®. Press and hold the reset button for 5 seconds and the screen will reveal the factory reset icon . NOTE: A factory reset will erase all patient data from the device the PIN will be reset to the default, 0000. Press to confirm the factory reset or to cancel. Cleaning Wipe the instrument and external surfaces with alcohol-free wipes. If in doubt, Bedfont® • supply instrument cleansing wipes, which we recommend and have tested with the device. NEVER use alcohol, cleaning agents that contain alcohol, or any other organic solvents on • the unit. The vapours produced will damage the electrochemical sensor inside and result in fault. NEVER immerse, or splash the device with liquid of any kind. •...
Operation Ensure the units battery is charged prior to use. If the device has been left for an extended • period of time, you may need to re-charge the unit. Press the ON/OFF button and release when the display becomes active. • The device can take up to 60 seconds to start up due to the stabilisation period, whilst air is • pumping over the sensor. NOTE: Make sure the vent holes are not covered at this time. Once switched on – all functions are controlled via the touchscreen interface. • Accessories NObreath® Dock The NObreath® monitor supplied is with a charging and synching docking station. This docking station is supplied with a USB cable which can be connect to the computer for synchronisation with the FeNOCHART™ software or plugged into the mains power adapter for charging the NObreath®. NOTE: Please only use the mains adapter and provided with the NObreath®. Failure to do so will may damage the monitor and invalidate the warranty. FeNOCHART™ software – connecting to the PC The NObreath® monitor is supplied with FeNOCHART™ software, which allows you to synchronise patient data from the device to your computer, where you can safely store and analyse results. 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, you can connect the micro USB lead directly 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.
Troubleshooting Issue/Alarm Possible Problem Remedial Action Place the device into the docking station or Battery requires charging connect directly to the USB cable which must be connected to a power source. Remove service door Remove breath dryer cartridge Battery not inserted Insert battery (see ‘preventive The unit fails to turn on maintenance’) Remove service door Remove breath dryer cartridge Battery out of position Reposition battery (see ‘preventive maintenance’) Component/software failure Contact your local Bedfont® representative Remove service door Remove breath dryer cartridge Battery not inserted Insert battery (see ‘preventive maintenance’) Remove service door Remove breath dryer cartridge Battery out of position Device will not charge Reposition battery (see ‘preventive maintenance’) Contact your local Bedfont® representative for Battery failure spares Component/software failure Contact your local Bedfont® representative Leave device in an atmospheric temperature of Device too cold to be calibrated 21°C ±4°C (68°F ±39°F) until the temperature range within the device has equilibrated.
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Place the device into the docking station or connect directly to the USB cable which must be connected to a Readings erratic Sensor has lost bias power source. Once power has been restored to the device and sensor battery wait 24 hours for sensor to regain bias Smoking status Medications Age/sex See ‘Contraindications section’ Respiratory manoeuvres Airway calibre Consult service manual if you have undergone service training. Pump running too slow Contact your local Bedfont® Readings abnormally low representative Consult service manual if you have undergone service training. Pump not running Contact your local Bedfont® representative Remove service door NO Scrubber not inserted Insert NO scrubber (see ‘preventive maintenance’) Check screen brightness, if able. (see ‘screen Screen brightness too low Pump running but nothing can be brightness’ section) seen on screen Component/software failure Contact your local Bedfont® representative Device is switched off Switch on device Consult service manual if you have undergone service training.
Place the device into the docking station or connect directly to the USB cable which must be connected to a power source RTC battery empty Consult service manual if you have undergone service training. Contact your local Bedfont® representative Only the supplied power adaptor and USB cable Indicates a fault: overcurrent, under should be used to connect the NObreath® dock Red light on the dock voltage or over voltage. to mains power. If yours is lost or damaged, contact your local Bedfont® representative. Returns procedure If your equipment requires servicing, please contact your local Bedfont® Customer Service Department, distributor or supplier before returning any goods. 1. When you have supplied the Customer Repairs Department with the monitor serial number and description of the fault, you will be issued with a returns/ticket number. Please state the returns/ticket number on the outside of the box when returning the monitor and ensure that your full details, telephone, fax number and return address are clearly stated. 2. The product must also be decontaminated before it is returned according to your local regulations. Bedfont® can provide you with a decontamination certificate to complete, which also needs to be attached to the outside of the box. Failure to do so will result in the product being subject to Bedfont® decontamination procedure and will delay your service/repair. 3. Bedfont® advise that you use a courier service when returning monitors. This enables you to insure goods for loss or damage in transit. When your goods are received, you will be sent an email stating so. 4. If the device has been returned for repair it will then be examined and you will be sent an ‘Engineer’s Report’ and a quotation for the repair, which will include an authorisation form. Complete the authorisation form, and ensure that you include the ‘Official Purchase Order Number’. Please contact the Customer Repairs Department if you are unable to supply an ‘Official Purchase Order Number’.
Spares Part Number Description NObreath® Mouthpiece The NObreath® mouthpiece contains a one-way valve to prevent patients drawing air back from the monitor. An integrated infection control filter removes and traps >99% of airborne bacteria and >96% of viruses Monitor cleaning wipes Free from alcohol to ensure continued performance of your monitor. Products containing alcohol cannot be used on any of the Smokerlyzer® range. Warranty Bedfont® Scientific Limited warrants the NObreath®, sensor 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. NOTE: The product warranty is automatically invalidated if the security seal is broken or if the products are repaired, altered or otherwise tampered with by unauthorised personnel, or have been subject to misuse, neglect or accident. 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. Single use consumables and accessories should be disposed of in line with local clinical waste guidelines. References Saito J, Gibeon D, Macedo P, Menzies-Gow A, Bhavsar P, Chung K. Domiciliary diurnal variation of exhaled nitric oxide fraction for asthma control. 2017. Correlation of Exhaled Nitric Oxide, Spirometry and Asthma Symptoms: Journal of Asthma: Vol 42, No 10 [Internet].Tandfonline.com. 2017 [cited 15 March 2017]. Available from: http://www.tandfonline.com/doi/abs/10.1080/02770900500371344 ATS/ERS Recommendations for Standardized Procedures for the Online and Offline Measurement of Exhaled Lower Respiratory Nitric Oxide and Nasal Nitric Oxide, 2005; American Journal of Respiratory and Critical Care Medicine; vol. 171: 912-930;2005 Public Health England. An Evaluation of Filtration Efficiencies Against Bacterial and Viral Aerosol Challenges Report No. 17/001. London: Public Health England; 2017.
Need help?
Do you have a question about the NObreath and is the answer not in the manual?
Questions and answers
Монитор не включается, прибор перед этим 1.5 года не использовался.
The Bedfont NObreath monitor may not be turning on after 1.5 years of inactivity because the batteries may be discharged or have leaked. The manual recommends ensuring the battery is charged prior to use and checking for battery leakage after extended periods of non-use.
This answer is automatically generated