Related Manuals for Spirosure FenomPro
Summary of Contents for Spirosure FenomPro
- Page 1 Asthma Monitor Instructions for Use IFU-3264 Rev B Instructions for Use, Fenom Pro...
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Page 2: Table Of Contents
Table of Contents Table of Contents Definitions Chapter 1: System Overview System Description Indications for Use Clinical Limitations Risks to Health Fenom Pro Components Table 1: Fenom Pro Device Components Display Buttons Table 2: Button and Indication Icons Chapter 2: Safety and Warnings Safety Instructions Compliance Warnings... - Page 3 Chapter 9: General Care Operating Conditions Cleaning Handling Storage Preventive Inspections Rechargeable Battery Maintenance Disposal of Used/Expired Equipment and Consumables Limited Warranty Chapter 10: Troubleshooting Support Add Tests Errors and Codes Table 4: Error Codes Chapter 11: Technical Data Dimensions and Weight Electrical Data Exhaled NO Performance Linearity...
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Page 4: Definitions
Definitions The following are the definitions for terms and abbreviations used in this manual Fractional exhaled Nitric Oxide – Amount of nitric oxide in the exhaled breath originating FeNO from the bronchial passages, not the nasal passages or upper airway. Forced Expiratory Volume in One Second –... -
Page 5: Chapter 1: System Overview
Chapter 1: System Overview System Description The Fenom Pro™ Asthma Monitor (henceforth known as Fenom Pro) is a point-of-care breath analyser that uses electrochemical technology to measure the fraction of exhaled nitric oxide (FeNO), a marker for airway inflammation, in human exhaled breath. -
Page 6: Fenom Pro Components
Fenom Pro Components Table 1: Fenom Pro Device Components Description Touch Screen Handpiece Battery Indicator – Battery strength is below 25% if only one bar is illuminated AC Power Indicator – Indicator is green when the device is powered on and connected to an electrical outlet. Power Button –... -
Page 7: Display Buttons
Display Buttons There are several button icons that Fenom Pro utilises to help you easily navigate through the menu screens. Table 2: Button and Indication Icons Buttons Icon Name Description Button used to open the Settings Menu. This menu allows for setting Time/ Settings Button Date, selecting Language, viewing System Information, selecting Volume Level, and Ordering Tests. -
Page 8: Chapter 2: Safety And Warnings
The following warnings apply in the handling and operation of Fenom Pro: Fenom Pro should only be operated by trained healthcare professionals. Operate Fenom Pro as stated in this manual. Spirosure accepts no responsibility for damaged equipment or faulty results if the equipment is not handled according to this manual. -
Page 9: Electromagnetic Emissions
DO NOT reuse the single-patient-use mouthpiece on other patients. DO NOT open, crush, incinerate, or heat the lithium-ion battery in the device above 140°F/60°C. DO NOT use the USB port to connect Fenom Pro to a computer. DO NOT touch the part of the mouthpiece that will go into the patient’s mouth. Either hold the mouthpiece using the plastic packaging or wear latex gloves while attaching to the handpiece. -
Page 10: Chapter 3: Fenom Pro Quick Start Guide
Chapter 3: Fenom Pro Quick Start Guide To perform a FeNO test, follow these three simple steps. For full test guidelines and instructions, see Chapters 4 and 5. For set-up instructions, see Chapter 8. NOTE: Check to make sure the device is powered on. If the device is on but the display is blank, touch the screen to wake up the device. - Page 11 The Fenom Pro will display the Stop Now screen and play an audible chime once the patient has successfully completed the breath manoeuvre. Results will display in 28 seconds. If the patient has the Fenom Connect™ Asthma Assistant installed on their mobile phone, allow the patient to scan the QR Code displayed in the bottom left corner.
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Page 12: Chapter 4: Feno Measurement Preparation
Chapter 4: FeNO Measurement Preparation NOTE: See Chapter 2: Safety and Warnings for a list of safety instructions and warnings. Wake up Device If the device is powered off, press the Power button to turn it on. NOTE: If the device is powered on but the display is blank, touch the screen to wake up the device. -
Page 13: Chapter 5: Perform Feno Measurement
Chapter 5: Perform FeNO Measurement The FeNO measurement is performed by the patient blowing into a single-patient-use mouthpiece that is attached to a handpiece. The patient must blow into the mouthpiece at a controlled rate, which is monitored through an animated graphic on the display. -
Page 14: Perform A Child Feno Test
Perform a Child FeNO Test NOTE: Complete the steps in Chapter 4: FeNO Measurement Preparation before continuing with the steps below. Lift the handpiece out of the cradle on top of the Fenom Pro. Remove the new, single-patient-use mouthpiece from its packaging without touching the part that will go into the patient’s mouth. -
Page 15: View Results
View Results Upon completion of the FeNO test, the patient’s breath is analysed, and the results are displayed in ppb. It takes approximately 28 seconds for the results to be displayed. View the FeNO result. If the patient has the Fenom Connect Asthma Assistant installed on their device, instruct the patient to open their app and scan the present QR Code for their test results. -
Page 16: Chapter 6: Power Off Device
Chapter 6: Power Off Device It is OK to leave the device powered-on at all times. Your device will automatically go into sleep mode when not being used. Only power off if you don’t intend to use for extended periods of time. To power off the device: Hold the POWER button down for at least 1 second. -
Page 17: Chapter 8: Device Set-Up
Chapter 8: Device Set-up Initial Set-up To set up the Fenom Pro device: Remove the device and power cable from the shipping package. NOTE: Retain all packaging for future transportation of the device. Connect the breath tube to the orange port at the bottom of the handpiece. Ensure the breath tube is fully seated against the rear surface, as shown in the figure. -
Page 18: Configuration Settings
Configuration Settings There are device settings that require configuring based on location and requirements. These settings are accessed through the Settings icon. (See Table 2: Indicators and Icons.) Device Settings The Settings button provides access to set the Time and Date, select Language, view System Info, select Test Incentive Sound level, and Add Tests. -
Page 19: System Information
System Information Press System Info on the Settings screen to view Device Serial Number, Licensed Tests (number of licensed tests remaining), Service Due Date, Software Version, and Firmware Version. Test Incentive Sound Press Test Incentive Sound on the Settings screen to set the desired volume level, High, Low, or Off. -
Page 20: Chapter 9: General Care
Chapter 9: General Care Follow the recommendations below for cleaning and general care of the Fenom Pro and its accessories. IMPORTANT! Never attempt to open or service the Fenom Pro device or components. Operating Conditions Ensure stable operating conditions by avoiding placement of the device in direct sunlight, near sources radiating heat, or ventilation. -
Page 21: Preventive Inspections
Limited Warranty Spirosure, Inc. warrants the Fenom Pro to be free of defects in materials and workmanship for a period of 18 months from the date of shipment. Spirosure’s sole obligation under this warranty is limited to repairing or replacing, at its discretion, any item covered under this warranty when such an item is returned intact and prepaid, to Spirosure or the local representative. -
Page 22: Chapter 10: Troubleshooting
Chapter 10: Troubleshooting The Fenom Pro device, sub-components, and accessories are not field serviceable. Support Please contact the distributor if the Fenom Pro presents any problems that cannot be solved with the actions stated in this manual. Add Tests The Fenom Pro requires licensed tests in order to perform FeNO measurements. -
Page 23: Errors And Codes
Errors and Codes In the event the device displays an error message, use Table 4 to look up the error code and perform the suggested actions to resolve the issue. Table 4: Error Codes Error Code Error Situation / Error Message Actions Cycle the power on the device. - Page 24 Error Code Error Situation / Error Message Actions Warning that the device date is 10-066 Set the device date in Settings. incorrect There was a failure on the device communicating with the sensors. Cycle the power on the device and try again. 20-001 If problem persists contact If problem persists, contact Technical Support.
- Page 25 Error Code Error Situation / Error Message Actions A failure has occurred on the device hardware. Please contact 45-051 Contact Technical Support. support. Issue: Calibration EEPROM CRC Failure. A failure has occurred on the device hardware. Please contact 45-052 Contact Technical Support. customer support.
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Page 26: Chapter 11: Technical Data
Chapter 11: Technical Data Dimensions and Weight Height: 145 mm Width: 230 mm Depth: 140 mm Weight (including handpiece): 2.4 kg Electrical Data Device power consumption: < 20 VA Power supply mains voltage: 100-240 V ~ 50-60 Hz Exhaled NO Performance The Fenom Pro is verified to fulfil performance herein under temperature ranges of 15-30°C (59-86°F), relative humidity of 20-80%, and pressure range of 106-80 kPa. -
Page 27: Chapter 12: Reference
Chapter 12: Reference Symbol Explanation WEEE Directive 2102/19/EU Manufacturer Keep out of rain & damp conditions Do not reuse Conformité Européenne In vitro diagnostic device conformance European Authorised Representative Use by YYYY-MM-DD (expiry) Caution, consult accompanying Catalogue part number documents Type BF applied part complying with Lot number IEC 60601-1... -
Page 28: Chapter 13: Parts And Accessories
Chapter 13: Parts and Accessories Warning! Any accessory not recommended by Spirosure, Inc. may result in loss of performance, damage to your Fenom PRO, or injury. The product warranty does not cover product failure or damage resulting from use with non-approved accessories. Spirosure, Inc. -
Page 29: Bibliography
QAdvis EAR AB Ideon Science Park Scheelevagen 17 SE-223 70 Lund, Sweden Spirosure Fenom Pro is CE marked according to In Vitro Device Directive IVDD 98/79/EC. FENOM is a registered trademark of Spirosure, Inc. IFU-3264 Rev B Instructions for Use, Fenom Pro...
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