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IFU-3393 Rev C Instructions for Use, Fenom Pro,

Asthma Monitor

Instructions for Use

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Содержание FenomPro

Страница 1: ...IFU 3393 Rev C Instructions for Use Fenom Pro Asthma Monitor Instructions for Use R...

Страница 2: ...ructions 8 Compliance 8 Warnings 8 Electromagnetic Emissions 9 Electromagnetic Immunity 9 Chapter 3 Fenom Pro Quick Start Guide 10 Chapter 4 FeNO Measurement Preparation 12 Wake up Device 12 Pre test...

Страница 3: ...onsumables 21 Limited Warranty 21 Chapter 11 Troubleshooting 22 Support 22 Add Tests 22 Error and Codes 23 Table 4 Error Codes 23 Chapter 12 Technical Data 26 Dimensions and Weight 26 Electrical Data...

Страница 4: ...city After the patient has taken in the deepest possible breath this is the volume of air that can be forcibly and maximally exhaled out of the lungs until no more can be expired usually measured in l...

Страница 5: ...patients that often occurs after treatment with anti inflammatory pharmacological therapy as an indication of therapeutic effect in patients with elevated FeNO levels FeNO measurements are to be used...

Страница 6: ...r Battery strength is below 25 if only one bar is illuminated 4 AC Power Indicator Indicator is green when the device is powered on and connected to an electrical outlet 5 Power Button Hold for one se...

Страница 7: ...s few tests are remaining Contact your distributor to order additional tests Quality Control Status Button QC Status Pass Button used to indicate current QC Mode Status Green icon indicates current QC...

Страница 8: ...ure Inc Technical Support o o DO NOT bring Fenom Pro in a room containing magnetic resonance equipment o o DO NOT bring Fenom Pro to a room adjacent to magnetic resonance equipment Compliance Fenom Pr...

Страница 9: ...ld ensure that their security systems and other equipment do not interfere with Fenom Pro o o DO NOT block device vents and ports while in use or while charging o o DO NOT drop the device or subject i...

Страница 10: ...ull capacity place mouth on the mouthpiece ensuring to keep tight seal so no air escapes and exhale for the full breath test duration at a steady flow 1 Select Start test on the Home Screen Remove a n...

Страница 11: ...11 3 The Fenom Pro will display the Stop Now screen and play an audible chime once the patient has successfully completed the breath maneuver Results will display in 28 seconds 4 Press the Done butto...

Страница 12: ...device is on a flat stable surface while performing a FeNO measurement 3 Confirm that the patient meets eligibility requirements o o Age 7 and up o o Has not consumed food or fluids other than water...

Страница 13: ...ockwise until secure 4 Hand the handpiece to the patient with the mouthpiece attached 5 Press the Start button on the test selection screen 6 Provide the patient with a brief overview on how to use th...

Страница 14: ...handpiece 2 Properly dispose of the used mouthpiece 3 Replace the handpiece in its cradle on top of the device View Results Upon completion of the FeNO test the patient s breath is analyzed and the r...

Страница 15: ...Touch the SELECT QC USER button 3 Select the user listed in the SELECT USER FOR TEST window that corresponds to the actual user that will perform a test If the user is not listed create a new user by...

Страница 16: ...ot recorded in this mode IMPORTANT Using the Practice mode counts as one exhalation toward the maximum six exhalations per patient per day and toward the maximum three exhalations per mouthpiece To ac...

Страница 17: ...handpiece in the cradle on top of the device 4 Connect the power cable from the rear panel of the device to an outlet See Table 1 for power connection location The AC Power Indicator displays green wh...

Страница 18: ...s These settings are accessed through the Settings icon See Table 2 Indicators and Icons Time Date 1 Touch Time Date on the Settings screen to set the date and time on the device 2 Use the and buttons...

Страница 19: ...ntive Sound on the Settings screen to set the desired volume level High Low or Off 2 A check mark indicates the current selection System Information 1 Touch System Info on the Settings screen to view...

Страница 20: ...pre moistened with 5 bleach solution at the end of each day of use o o DO NOT use spray detergents Handling o o Take care while handling the device o o DO NOT drop the device or the handpiece o o Car...

Страница 21: ...posal of Used Expired Equipment and Consumables o o Expired devices should be recycled according to the local program for electronic equipment o o Used or expired mouthpieces should be recycled accord...

Страница 22: ...eNO measurements When the number of licensed tests approaches zero the Licensed Tests Status Button will turn red To order additional tests follow three simple steps 1 Contact Spirosure support repres...

Страница 23: ...performing a shortened test See Chapter 10 Shortened Test Mode For Research Only 10 020 The test was stopped because breath airflow exceeded the maximum threshold Please try again Restate the proper b...

Страница 24: ...em persists contact Technical Support 40 066 The test was stopped because flow variability was outside the allowed threshold Please try again Wait one minute and try again If problem persists contact...

Страница 25: ...lease contact customer support Issue Board Temperature High Contact Technical Support 45 063 A failure has occurred on the device hardware Please contact support Issue Battery Charger Failure Contact...

Страница 26: ...ative humidity of 20 80 and pressure range of 106 80 kPa Linearity Slope 1 00 0 05 Squared correlation coefficient r2 0 998 Precision NO concentrations 50 ppb 5 ppb NO concentrations 50 ppb 10 of the...

Страница 27: ...entration were made eight times a day for five days across five different devices Repeatability is an estimated of variation withing one test run in one day Within device precision is an estimate of v...

Страница 28: ...elow The accuracy for all test cases within the technical specification Device 10 ppb 25 ppb 75 ppb 100 ppb 200 ppb 100179 1 8 2 8 3 8 1 4 0 4 100180 2 0 2 2 0 4 0 4 3 4 100183 2 0 3 4 1 8 0 0 2 8 100...

Страница 29: ...s not rated for use near magnetic resonance Caution consult accompanying documents Type BF applied part complying with IEC 60601 1 Non Sterile Consult instructions for use Operating humidity range Int...

Страница 30: ...alth and safety problems or other problems caused by the use of accessories not approved by Spirosure Parts o o Fenom Pro Model No 900 0001 o o Packaged Fenom Pro P N 900 0005 o o Fenom Pro Power Cabl...

Страница 31: ...in an allergy clinic population Allergy Asthma Proc 2011 vol 32 pp 119 126 6 K Ansarin J M Chatkin I M Ferreira C A Gutierrez N Zamel and K R Chapman Exhaled nitric oxide in chronic obstructive pulmo...

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