Bedfont FENObreath User Manual Download Page 56 | Manualshive

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55

Humidity limitation

Indicates the range of

humidity to which the

medical device can be

safely exposed

ISO 15223 – 1. Clause 5.3.8

ISO 7000 – 2620

Atmospheric pressure

limitation

Indicates the range of

atmospheric pressure

to which the medical

device can be safely

exposed

ISO 15223 – 1. Clause 5.3.9

ISO 7000 – 2621

General symbol for

recovery/recyclable

To indicate that the

marked item or its

material is part of a

recovery or recycling

process

ISO 7000 – 1135

Non-standard symbols

Title of Symbol

Symbol

Explanatory Test

Symbol and Standard

References

CE mark

Manufacturer’s

declaration of

compliance to all

relevant European

Medical Device

Regulations

European Directive

93/42/EEC

Bedfont® Scientific logo

Manufacturer’s logo

N/A

MGC Diagnostics Corporation

logo

Distributor’s logo

N/A

Type of protection against

electric shock

Internally powered

equipment

N/A

N/A

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.

N/A

N/A

Wireless

This device contains a Microchip Technology Inc. transmitter module IC: 6514A-RN42 FCC ID# T9J-
RN42 in compliance with FCC rules, Part 15 Spread Spectrum Transmitter

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.

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Summary of Contents for FENObreath

Page 1: ......

Page 2: ... 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 vent holes on the device at any time unless instructed to do so during servicing Blocking t...

Page 3: ...ubber contains potassium permanganate and should not be tampered with or exposed to skin CAUTION The NO scrubber contains potassium permanganate and should be disposed of as hazardous waste in accordance with local waste disposal regulations NOTE Ensure the patient inhales through the mouth not the nose before exhaling through the mouthpiece NOTE MGC Diagnostics Corporation advise the FeNObreath i...

Page 4: ...ing a Breath Test 13 Patient profiles 15 Maintenance 19 Settings 21 Data Reset 30 Quality Check and Calibration 32 Calibration using a CaliBag 41 Cybersecurity 45 Technical Specification 46 Buttons Explained 47 Troubleshooting 48 Glossary of Symbols and Safety Information 53 Wireless 55 Emissions 57 Immunity 57 Summary of the clinical data 59 Analytical Performance Data 61 Interpretation of FeNO V...

Page 5: ...lease refer to the Safety Information section of this manual for more information on the compliance of the FeNObreath Intended Use The FeNObreath is a portable non invasive device for the measurement of Fractional Exhaled Nitric Oxide FeNO in human breath The production of nitric oxide is often found to be increased in inflammatory conditions such as asthma Measurement of FeNO by FeNObreath is a m...

Page 6: ...e FeNObreath cannot be used with infants or by children under the age of 7 as measurement requires patient cooperation FeNObreath should not be used in critical care emergency care or in anesthesiology Contraindications There are no known contraindications Parts and Accessories 1 FeNObreath Dock 2 USB cable 3 Power plug and universal adaptors 4 Interpretation chart 5 FeNObreath mouthpiece 6 Microf...

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

Page 8: ...be operated in an environment outside of the temperature or humidity ranges stated in the technical specification 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 How to charge the FeNObreath The FeNObreath FeNO monitor comes with a Dock and charging cable to keep the monitor at hand and full...

Page 9: ...l outlet please make sure that it is plugged in to a location that is safe and easily accessible 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 Place the FeNObreath monitor into the Dock The screen will indicate that the monitor is charging ...

Page 10: ...eNObreath This can then be connected either to the pre approved power adapter or a computer USB port 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 monitor and sensor ...

Page 11: ... 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 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 performin...

Page 12: ...11 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: ...12 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: ...ale through the mouthpiece NOTE Ensure the patient inhales through the mouth not the nose before exhaling 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 second...

Page 15: ...e of the road Keep the dial in the green area Keep the car in the middle of the road Follow the bubbles A green check mark onscreen indicates a successful test 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 ...

Page 16: ...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 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 MGC Diagnostics Corporation or its local distributo...

Page 17: ...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: ...ent profile 3 Take an adult breath test 4 Take a child breath test 5 Return to the profile list 6 Return to the home screen 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 or ID from the list ...

Page 19: ... 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 Press the red x to delete the patient profile ...

Page 20: ...tics Corporation or the local service center The Health Care Professional can check how many breath tests have been performed on the device using the Information Screen Test No as seen below Routine maintenance 1 Mouthpieces are to be replaced after every patient WARNING The mouthpieces are single patient use only and can be used for a maximum of 3 tests Further re use could cause incorrect readin...

Page 21: ...placed annually and is included in the CaliBag kit and NO sensor exchange kit 3 The FeNObreath is warranted for 5 years providing calibrations are performed annually and the device is intended to be replaced or refurbished at the end of 5 years This is to include replacing the NO sensor breath drying cartridge and pump MGC Diagnostics Corporation or a local distributor can arrange for this service...

Page 22: ...d 12h or 24h for the time format The gray 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 Test log To access the test log press the log icon on the 1st page of the settings menu ...

Page 23: ...on to return to the main screen 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 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 MGC Diagnostics Corporation or its local distri...

Page 24: ...23 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: ...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 Enable disable PIN To disable the PIN press the enable disable PIN icon on the 1st page of the settings menu ...

Page 26: ...he 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 Change flow meter style To change the flow meter style press the flow meter button on the 1st page of the settings menu ...

Page 27: ...26 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: ...n 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 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: ...to return to the main screen To adjust the brightness of the display 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 30: ...the settings menu or the home icon to return to the main screen Bluetooth pairing To pair a device with the FeNObreath go to the 2nd page of the settings menu and press the Bluetooth pairing icon The screen will display the Bluetooth pairing PIN Please make sure the Bluetooth on the FeNObreath and the other device is switched on in order to pair with the FeNObreath Press the back arrow to return t...

Page 31: ...h 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 This will reveal the Data Reset button at the top right of the FeNObreath ...

Page 32: ... reset to the default 0000 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 Ensure that the breath drying cartridge has been re inserted and then reattach the back cover ...

Page 33: ...arried out using filtered ambient air and 100ppb Nitric Oxide Quality Check Bag MGC Diagnostics Corporation or the local service center can do this or a CaliBag kit can be purchased separately see CaliBag component layout below Before carrying out the 2 step quality check ensure the ambient level of nitric oxide is 100ppb To carry out an ambient check follow the procedure within this manual If the...

Page 34: ... 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 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: ...O reading 5ppb in which you may proceed to carrying out the 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: ...itched 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 To remove the scrubber first press down on clip at the top left hand side of the monitor ...

Page 38: ...sal regulations Using the same NO Scrubber from the Quality Check without gas insert this into the FeNObreath 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: ...heck Bag are closed and remove a Blue Plug from one end NOTE Make sure the Quality Check Bag is being used The Quality Check Bag contains the lower concentration of 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: ...39 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: ...tion written on the Quality Check Bag label For guidance please refer to the Quality Check conversion chart which can be found in the Calibration Kit Quick Start Guide If the NO reading is not within 10 of the concentration written on the Quality Check Bag label your FeNObreath requires a calibration To calibrate your device with the CaliBag follow the instructions provided Ensure both Bag Clamps ...

Page 42: ... replacement kit can be purchased separately which is supplied with replacement instructions 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 Device too cold to be calibrated Leave device in an atmospheric te...

Page 43: ... to the rubber end of the CaliAdapter 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: ...s to adjust the NO concentration on screen to match the value of the 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: ...tomatically calibrate drawing the gas from the CaliBag A successful calibration is shown by a green check mark Press save to complete the calibration An unsuccessful calibration is shown by a red cross If an unsuccessful calibration is shown by a red cross contact MGC Diagnostics Corporation or the local distributor ...

Page 46: ... to a PC laptop via USB or Wireless Ensure the PC laptop is in a secured environment e g has a firewall and anti virus software in order to not expose the FeNObreath to malwares CAUTION The operating system of the PC laptop should be kept up to date 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 f...

Page 47: ...ut 100 240V 50 60Hz 0 2A Output 5 0V 1 0A T90 response time 10 seconds Temperature Operating 15 30 C 59 86 F Storage transport 0 50 C 32 122 F Calibration 21 C 4 C 17 C 24 C 70 F 7 F 63 F 77 F Humidity Operating 20 80 RH non condensing Storage transport 5 95 RH non condensing Operating transport storage Altitude 1700 ft to 6300 ft Operating transport storage pressure 800 1080mbar Expected sensor o...

Page 48: ...02lb Materials Polypropylene Buttons Explained Information Retry Change PIN Adult test Save Disable PIN Child test Next screen Enable PIN Demo mode Previous screen Change flow meter style Patient profiles Settings Ambient test Home button Date time Disable Bluetooth Graph of results Selected Enable Bluetooth Delete patient Increase Service Area See service manual Confirm Decrease 5 year service Ca...

Page 49: ...ossible Cause Recommended Action 365 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 Possible Cause Recommended Action 5 years has elapsed since first calibration 5 year maintenance service is required This should be carried out by a trained engineer This will be displayed every day until a full service h...

Page 50: ...orrectly inserted Ensure the sensor is correctly inserted by pushing firmly in the top connector Check the date time If this does not show the current date time the real time clock battery may be flat empty Change the date time to the current date time and charge the device battery fully Sensor bias battery flat empty Charge the device battery fully This will allow the sensor bias battery to also ...

Page 51: ...ssarily an example of an erroneous reading Possible Cause Recommended Action The device may be out of specification If the user suspects the device is giving erroneous readings stop using it and contact MGC Diagnostics Corporation or the local service center The device may have been exposed to high levels of volatile organic compounds VOC s for example from cleaning agents Allow the device to rest...

Page 52: ...e device Replace the back cover Possible Cause Recommended Action 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 if after multiple attempts the patient is unable to comply the reading can be viewed by pressing the next arrow WARNING Patients should exhale for the duration...

Page 53: ... reading incorrectly or showing 0ppb The pump is not running The battery is low Charge the device battery The mouthpiece connection was loose during the test Ensure the mouthpiece is connected tightly Check if any VOC s or alcohol based products have been used to wipe the device or mouthpiece Alcohol contaminations will affect the Nitric Oxide electro chemical sensor inside the device Ensure no VO...

Page 54: ...itter Make Microchip Module RN42 Bluetooth FCC ID T9J R942 To indicate generally elevated potentially hazardous levels of non ionizing radiation or to indicate equipment or systems e g in the medical electrical area that include RF transmitters or that intentionally apply RF electromagnetic energy for diagnosis or treatment IEC 60601 1 2 Clause 5 1 1 IEC 60417 5140 Direct current To indicate on th...

Page 55: ...SO 7000 2497 FDA 21 CFR 801 Magnetic Resonance MR unsafe 3 1 14 An item which poses unacceptable risks to the patient medical staff or other persons within the MR environment ASTM F2503 20 Table 2 Symbol 7 3 3 7 4 9 1 Fig 9 Caution Indicates that caution is necessary when operating the device or control close to where the symbol is placed or that the current situation needs operator awareness or o...

Page 56: ...ive 93 42 EEC Bedfont Scientific logo Manufacturer s logo N A MGC Diagnostics Corporation logo Distributor s logo N A Type of protection against electric shock Internally powered equipment N A N A 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 N A N A Wireless This...

Page 57: ...putted level A deviation of 5ppb has no physiological significance WARNINGS Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any part of the FeNObreath Monitor including cables specified by the manufacturer Otherwise degradation of the performance of this equipment could result The FeNObreath Mo...

Page 58: ...ded the following warning is heeded WARNING This equipment system is intended for use by healthcare professionals only This equipment system may cause radio interference or may disrupt the operation of nearby equipment It may be necessary to take mitigation measures such as re orienting or relocating the FeNObreath monitor or shielding the location Immunity Guidance and manufacturer s declaration ...

Page 59: ...ptions beyond that provided by the battery it is recommended that the FeNObreath is powered from an uninterruptible power supply 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 commercial or hospital environment Electromagnetic Immunity The FeNObreath is intended for use in the electromagnetic enviro...

Page 60: ...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 Participants were asked to obtain 2 FeNObreath measurements with the assistance of 3 health care professionals HCPs for a total of 6 FeNObreath evaluations per partici...

Page 61: ...fall in mean FeNO measured by FeNObreath in patients with elevated FeNO levels for combined adult and pediatric treatment population n 139 Results showed a mean change of 13 7ppb 27 7 with a mean SD of 17 8 The Decline in FeNO was accompanied by the following changes in subjective and objective asthma measures The following secondary outcome measures showed the following after 2 weeks of corticost...

Page 62: ...formed over 5 days 2 sessions per day 2 measurements per session across 15 separate devices Repeatability is an estimation of variation within 1 test run in 1 day Within device precision is an estimate of variation between test runs and days FeNObreath s precision reproducibility is claimed to be a standard deviation of 5ppb for readings 50ppb and a CV of 10 for readings 50ppb The precision reprod...

Page 63: ...rg statements resources allergy asthma feno document pdf 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 limited to repairing or replacing at its choi...

Page 64: ... 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 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...

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