Bedfont NObreath FeNO User Manual Download Page 43

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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
flammable anaesthetic mixture with air, oxygen or
nitrous oxide

Equipment not suitable for use in the presence of

flammable mixtures.

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

Summary of Contents for NObreath FeNO

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

Page 2: ...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 th...

Page 3: ...ation and Set up 5 User Interface 5 Demo mode 8 Performing a Breath Test 11 Patient profiles 14 Maintenance 20 Settings 21 Data Reset 35 Technical Specification 38 Using the NObreath with FeNOchart 39 Buttons Explained 39 Troubleshooting 40 Safety Information 42 Parts and accessories 44 Warranty 45 Returns 45 Responsible Manufacturer and Contacts 45 ...

Page 4: ...reath 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 in...

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

Page 6: ...on 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: ... 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: ...7 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: ... 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: ...9 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: ...10 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: ...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: ...r will guide the patient on the exhalation rate Keep the car in the middle of the road Keep the dial in the green area Keep the car in the middle of the road Follow the bubbles A green tick onscreen indicates a successful test ...

Page 14: ... 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: ...tient 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: ...15 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: ...o 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: ...17 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: ... 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: ...19 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: ...ervicing 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 ...

Page 22: ...ither 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: ...age 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: ...that the PIN is changed to a memorable 4 digit number To change the PIN number press the change PIN icon from the 1st 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: ...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 ...

Page 26: ...25 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: ...d 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 1st page of the settings menu ...

Page 28: ...er 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: ...28 Change flow meter style To change the flow meter style press the flow meter button on the 1st page of the settings menu Select either the adult or child test mode to change the flow meter style ...

Page 30: ...29 The current flow meter style will be highlighted Select the new style and press the save icon to register ...

Page 31: ... 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 1st page of the settings menu ...

Page 32: ...Obreath 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: ...ay go to the 2nd 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 2nd page of the settings menu and press the enable disable Bluetooth button ...

Page 34: ...tooth 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 2nd page of the settings menu and press the Bluetooth pairing icon ...

Page 35: ...uetooth 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: ...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: ...e 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: ...37 All data will be erased and the home screen will display once more ...

Page 39: ...dity Operating 25 80 RH non condensing Storage transport 5 95 RH non condensing Operating transport storage pressure Atmospheric 10 Sensor operating life 5 years subject to servicing Sensor sensitivity 1ppb Sensor drift 5 per annum Dimensions Approx 90 x 159 x 59 mm Weight Approx 400g Materials NObreath monitor Case polycarbonate ABS blend SteriTouch anti microbial additive NObreath Dock Breath te...

Page 40: ...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 Nex...

Page 41: ...s 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: ... unit is secure and the 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: ...0 not protected against water ingress Degree of safety application in the presence of a flammable anaesthetic mixture with air oxygen or nitrous oxide Equipment not suitable for use in the presence of flammable mixtures 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 Be...

Page 44: ...ply IEC 61000 4 11 Power frequency 50 60Hz Magnetic field IEC 61000 4 8 30 A m 30 A m Power frequency magnetic fields should be at levels characteristic of a typical location environment Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 10V m 1kHz 80 80MHz 2 7GHz 10V m 1kHz 80 80MHz 2 7GHz Portable and mobile RF communications equipment should be used no closer to the NObreath than the recommen...

Page 45: ...rs 4 NObreath Forum information 5 Interpretation chart 6 NObreath mouthpiece 7 Microfiber cloth 8 Quick Start Guide 9 Screwdriver 10 Infection Control Maintenance Guidelines 11 Patient Preparation 1 Quick Start 8 2 9 3 6 7 Infection Control Maintenance Guidelines NObreath Forum 4 5 10 11 ...

Page 46: ...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 domesti...

Page 47: ...854860 Email ask bedfont com www bedfont com 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 Bedfont Scientific Limited 2019 Our family innovating health for yours est 1976 ...

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