CAIRE
FenomPro Instructions for Use Rev G
Instructions for Use
30 Pages
Preview
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Asthma Monitor
Instructions for Use
IFU-3393 Rev G Instructions for Use, Fenom Pro,
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Table of Contents Definitions
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Chapter 1: System Overview
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System Description Indications for Use Clinical Limitations Risks to Health Fenom Pro Components Table 1: Fenom Pro Components Display Buttons Table 2: Button and Indication Icons
Chapter 2: Safety and Warnings
Safety Instructions Compliance Warnings Electromagnetic Emissions Electromagnetic Immunity
5 5 5 5 6 6 7 7
8 8 8 8 9 9
Chapter 3: Fenom Pro Quick Start Guide
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Chapter 4: FeNO Measurement Preparation
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Wake up Device Pre-test Check
Chapter 5: Perform FeNO Measurement Perform a FeNO Test Remove Mouthpiece
12 12
13 13 14
Chapter 6: Quality Control 15 Perform a QC Test
15 15 15
Chapter 7: Power Off Device
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Chapter 8: Practice Mode
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Chapter 9: Device Setup
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QC User Status Create QC Users
Initial Setup Configuration Settings Device Settings Time/Date Language
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17 17 17 17 17
IFU-3393 Rev G Instructions for Use, Fenom Pro
System Information Test Incentive Sound Add Tests Quality Control Status
Chapter 10: General Care
Operating Conditions Cleaning Handling Storage Preventive Inspections Rechargeable Battery Maintenance Disposal of Used/Expired Equipment and Consumables Limited Warranty
Chapter 11: Troubleshooting
Support Add Tests Error and Codes Table 4: Error Codes
Chapter 12: Technical Data
Dimensions and Weight Electrical Data Exhaled NO Performance Linearity Precision Accuracy Limit of Detection Measurement Range Exhalation Parameters
Chapter 13: Device Performance Accuracy Limit of Detection
Chapter 14: Reference
Symbol Explanation
Chapter 14: Parts and Accessories Parts Accessories
IFU-3393 Rev G Instructions for Use, Fenom Pro
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20 20 20 20 20 21 21 21 21 21
22 22 22 23 23
26 26 26 26 26 26 26 26 26 26
27 28 28
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30 30 30
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Definitions The following are the definitions for terms and abbreviations used in this manual
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FeNO
Fractional exhaled nitric oxide – Amount of nitric oxide in the exhaled breath originating from the bronchial passages, not the nasal passages nor upper airway.
FEV1
Forced Expiratory Volume in One Second - Volume of air that can be forcibly exhaled from the lungs in the first second of a forced expiratory maneuver, measured in liters.
FEV6
Forced Expiratory Volume in Six Seconds - Volume of air that can be forcibly exhaled from the lungs in the six seconds of a forced expiratory maneuver, measured in liters.
FVC
Forced Vital Capacity - 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 liters.
NO
Nitric oxide – Produced by the human lung and is present in the exhaled breath. It has been implicated in the pathophysiology of lung diseases, including asthma.
PEF
Peak Expiratory Flow - Maximal flow (or speed) achieved during the maximally forced expiration initiated at full inspiration, measured in liters per minute or in liters per second.
Spirometry
Common office test used to assess how well a patient’s lungs work by measuring how much air is inhaled, how much is exhaled, and how quickly it is exhaled.
IFU-3393 Rev G Instructions for Use, Fenom Pro
Chapter 1: System Overview System Description CAIRE Diagnostics Fenom Pro is a point-of-care breath analyzer that uses electrochemical sensor technology to measure the fraction of exhaled nitric oxide (FeNO), a marker for airway inflammation, in human exhaled breath. Measurement of FeNO by Fenom Pro is quantitative, non-invasive (only the mouthpiece comes in contact with the patient), simple and safe. Fenom Pro is designed as a hand-held device for measuring FeNO in exhaled breath from humans. The level of exhaled nitric oxide (NO) is frequently increased in some inflammatory processes such as asthma. The fractional NO concentration in expired breath can be measured by the Fenom Pro device according to guidelines for NO measurement established by the American Thoracic Society (ATS) and European Respiratory Society (ERS). Fenom Pro provides direct sampling with result report within 30 seconds of sequentially collected and analyzed exhaled air. No subsequent specific specimen collection, specimen preparation, or reagents are required. The emissions characteristics of the Fenom Pro device make it suitable for use in point of care sites and hospitals (CISPR 11 class A).
Indications for Use Fenom Pro Nitric Oxide Test is a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. FeNO is increased in some airway inflammatory processes, such as asthma, and often decreases in response to anti-inflammatory treatment [1]. Measurement of FeNO by Fenom Pro is a method to measure the decrease in FeNO concentration in asthma 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 as an adjunct to established clinical assessments. Fenom Pro is suitable for children, approximately 7-17 years, and adults 18 years and older. Testing using the Fenom Pro should only be done in a point-of-care healthcare setting under professional supervision. Fenom Pro should not be used in critical care, emergency care or in anesthesiology.
Clinical Limitations Fenom Pro may not be used by children under the age of approximately 7 years, including infants, as measurement requires patient cooperation. Fenom Pro may not be used by children under the age of 7 years, or by patients who are unable to understand and execute the instructions given by healthcare providers, as measurement requires patient cooperation. Fenom Pro should not be used in critical care, emergency care, or in anesthesiology. All subjects should refrain from eating or drinking for at least 60 minutes before the FENOM test. Recent intake of nitrate rich food, such as lettuce, spinach, beets, walnuts, peanuts, and animal organs, can lead to increased FeNO levels [2]. Smoking reduces exhaled NO levels [3]. Fenom results obtained from subjects who smoke should only be considered after considering the subject’s smoking history and the potential impact on NO levels.
Risks to Health There are no known direct risks to patient health posed by use of Fenom Pro. However, failure of the test to perform as indicated or erroneous interpretation of results may lead to improper patient management. Therefore, use of FeNO measurement results to adjust a treatment regimen without consideration of other clinical factors could pose a risk. [1] “ATS/ERS Recommendations for Standardized Procedures for the Online and Offline Measurement Exhaled Lower Respiratory Nitric Oxide and Nasal Nitric Oxide, 2005.” Am. J. Respir. Crit. Care Med., 2005; vol. 171, pp. 912–930. [2] A. C. Olin, A. Aldenbratt, A. Ekman, G. Ljungkvist, L. Jungersten, K. Alving, and K. Toren, “Increased nitric oxide in exhaled air after intake of a nitrate-rich meal.” Respir. Med., 2001; vol. 95, pp. 153–158. [3] Buszewski B, Ulanowska A, Ligor T, Denderz N, Amann A., “Analysis of exhaled breath from smokers, passive smokers and non-smokers by solid phase microextraction gas chromatography/mass spectrometry” Biomed Chromatogr. 2009 May;23(5):551-6. doi: 10.1002/bmc.1141.
IFU-3393 Rev G Instructions for Use, Fenom Pro
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Fenom Pro Components 2
3 4 5
1
7 6
2 8
9 Table 1: Fenom Pro Components
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No.
Description
1
Touch Screen
2
Handpiece
3
Battery Indicator –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 second to power on/off.
6
Single-Patient-Use Mouthpiece (accessory)
7
Carrying Handle
8
24 V Power Connection
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USB Type-B Port IFU-3393 Rev G Instructions for Use, Fenom Pro
Display Buttons There are several button icons that Fenom Pro utilizes to help you easily navigate through the menu screens. Table 2: Button and Indication Icons Buttons Icon
Name
Description
Settings Button
Button used to open the Settings Menu. This menu allows for setting Time/Date, selecting Language, viewing System Information, selecting Volume Level, and Ordering Tests.
Test License Status Button (Tests available)
Button used to open Order Tests box. Green checkmark indicates that the device has tests available. Not used in some configurations.
Test License Status Button (Few tests available)
Button used to open Order Tests box. Red exclamation point indicates few tests are remaining. Contact your distributor to order additional tests. Not used in some configurations.
Quality Control Status Button (QC Status - Pass) Quality Control Status Button (QC Status - Fail) Quality Control Status Button (QC Status - Disabled)
Humidity Error Button
Humidity Warning Button
Service Due Button
IFU-3393 Rev G Instructions for Use, Fenom Pro
Button used to indicate current QC Mode Status. Green icon indicates current QC Mode status is passed.
Button used to indicate current QC Mode Status. Red icon indicates current QC Mode status is failed or expired.
Button used to indicate current QC Mode Status. Gray icon indicates current QC Mode status is temporarily disabled or analyzing.
Button used to open the current humidity error condition status. When displayed, FeNO tests are disabled.
Button used to open the current humidity condition warning status
Button used to open the Service Due warning. If displayed, Fenom Pro service is due soon. Contact your distributor to schedule service.
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Chapter 2: Safety and Warnings Safety Instructions The following safety instructions apply in the handling and operation of Fenom Pro: o
DO NOT inhale through the device.
o
DO NOT inhale through the mouthpiece.
o
DO NOT exhale beyond the limits of your physical ability.
o
Discontinue measurements if the breath maneuver is laborious for the patient.
o
DO NOT allow use of Fenom Pro within 15 minutes after performing spirometry testing such as: FEV1, FEV6, FVC, PEF, etc.
o
DO NOT allow use of Fenom Pro within 60 minutes after exercising or smoking.
o
DO NOT use the Fenom Pro device without a new single-patient-use mouthpiece.
o
DO NOT perform more than six breath attempts on a single patient within one day.
o
If repeated measurements taken for at least two consecutive days are more than 10 ppb different contact CAIRE Diagnostics Inc. Technical Support.
o
DO NOT bring Fenom Pro in a room containing magnetic resonance equipment.
o
DO NOT bring Fenom Pro to a room adjacent to magnetic resonance equipment.
Compliance Fenom Pro is CE-marked according to the In Vitro Diagnostics Directive 98/79/EC. Fenom Pro is RoHS compliant according to Directive 2011/65/EU Restriction of Hazardous Substances in Electrical and Electronic Equipment as amended by Directive 2015/863.
Warnings The following warnings apply in the handling and operation of Fenom Pro:
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Fenom Pro should only be operated by trained healthcare professionals.
o
Operate Fenom Pro as stated in this manual. CAIRE Diagnostics accepts no responsibility for damaged equipment or faulty results if the equipment is not handled according to this manual.
o
DO NOT use a damaged Fenom Pro device, damaged components, or damaged accessories.
o
Use only power supply unit provided.
o
Keep the device out of water. Ensure no liquid is spilled or dripped on the device.
o
DO NOT use the Fenom Pro device adjacent to or stacked with other equipment because it could result in improper operation.
IFU-3393 Rev G Instructions for Use, Fenom Pro
o
DO NOT block device vents and ports while in use or while charging.
o
DO NOT drop the device or subject it to strong impact.
o
No modification of the Fenom Pro device, handpiece, or mouthpiece is allowed.
o
DO NOT use Fenom Pro in the proximity of areas where volatile substances such as organic fluids or disinfectants are being used. Special attention should be paid to aerosols and disinfection baths.
o
DO NOT use Fenom Pro in the presence of flammable vapors or liquids
o
Use of substances containing alcohol close to the Fenom Pro device may cause erroneous measurement results. [4]
o
Single-patient-use mouthpiece should be used immediately after opening.
o
DO NOT reuse the single-patient-use mouthpiece on other patients.
o
When not in use, the Fenom Pro device should be stored in the packaging provided. (See Chapter 12: General Care.)
o
DO NOT open, crush, heat above 140 °F/60 °C, or incinerate the lithium-ion battery in the device.
Electromagnetic Emissions The emissions characteristics of this equipment make it suitable for use in hospitals and other healthcare settings (CISPR 11 class A).
Electromagnetic Immunity Fenom Pro has been tested to comply with the emission and immunity requirements described in IEC 606011-2:2014 (4th Edition) General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests and AIM 7351731:2017 Medical Electrical Equipment and System Electromagnetic Immunity Test for RFID Readers. Fenom Pro is not compatible with magnetic resonance systems, and is labeled as MR Unsafe. The Fenom Pro should not be used in a room containing a magnetic resonance system or adjacent rooms to a magnetic resonance system. Note: Sites should ensure that their security systems and other equipment do not interfere with Fenom Pro.
[4] R. J. Meijer, H. A. Kerstjens, D. S. Postma, G. H. Koeter, T. W. van der Mark, “Exhaled nitric oxide concentration is influenced by alcohol containing disinfectants.” Eur. Respir. J., 1996; vol. 9, p.1111.
IFU-3393 Rev G Instructions for Use, Fenom Pro
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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 setup instructions, see Chapter 9. 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. The device may take one minute to warm up.
1.
Select Start test on the Home Screen. Remove a new single-patient-use mouthpiece from its packaging and attach it to the hand-piece by pressing the mouthpiece towards the top of the hand-piece and twist clockwise to secure. Be careful to not touch the part of the mouthpiece that will have patient contact.
NOTE: See Chapter 8: Practice Mode if patient requires a demonstration before taking the test. 2.
Touch the Begin Test button and instruct the patient to inhale naturally to full 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.
Instruct the patient to keep the indicator over the star at the top of the gauge. NOTE: Having the indicator within the green range is also acceptable.
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IFU-3393 Rev G Instructions for Use, Fenom Pro
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 button and properly dispose of the used mouthpiece.
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Chapter 4: FeNO Measurement Preparation NOTE: See Chapter 2: Safety and Warnings for list of safety instructions and warnings.
Wake up Device 1.
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. Allow the device to warm-up for one minute.
Pre-test Check 1.
Check the battery indicator to ensure the unit has sufficient battery power to perform a FeNO measurement. If the battery indicator is below 25%, plug device into the power supply before using.
2.
Check that device is on a flat, stable surface while performing a FeNO measurement.
3.
Confirm that the patient meets eligibility requirements: o Age 7 and up. o Has not consumed food or fluids other than water in the preceding 60 minutes. o Has not exercised or smoked in the preceding 60 minutes.
4.
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When pre-test check is complete, proceed with Chapter 5: Perform FeNO Measurement.
IFU-3393 Rev G Instructions for Use, Fenom Pro
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 touch display. Once a sufficient amount of the patient’s breath is captured, the sensor analyzes the breath and reports a FeNO score in parts per billion (ppb).
Perform a FeNO Test NOTE: Complete the steps in Chapter 4: FeNO Measurement Preparation before continuing with the steps below. 1.
Lift the handpiece out of the cradle on top of the Fenom Pro.
2.
Remove the new, single-patient-use mouthpiece from its packaging without touching the part that will go into the patient’s mouth.
3.
Attach the mouthpiece to the handpiece by firmly grasping the outer diameter of the mouthpiece and pushing towards the top of the handpiece while twisting clockwise 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 the Fenom Pro device. o
Instruct patient to inhale naturally to full capacity before placing mouth on the mouthpiece.
o
Instruct patient to place mouth on the mouthpiece and exhale for a full 10 seconds at a steady flow.
o
Instruct patient to keep lips sealed around the mouthpiece so no breath escapes from patient’s lips.
NOTE: See Chapter 8: Practice Mode if patient requires a demonstration before taking the test.
7.
Touch the Begin Test button when the patient understands the instructions and is ready to begin.
8.
The visual incentive gauge displays.
9.
Instruct the patient to begin exhaling into the mouthpiece whenever ready.
10. Ensure that the patient stops exhaling once the Stop Now screen is displayed. 11. If the patient was unsuccessful in performing a breath maneuver, review the reason for the failure. If necessary, patient can attempt a test in Practice Mode (Chapter 8) before repeating. 12. Proceed to instructions in View Results section of this Chapter.
IFU-3393 Rev G Instructions for Use, Fenom Pro
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View Results Upon completion of the FeNO test, the patient’s breath is analyzed, and the results are displayed in ppb. It takes approximately 28 seconds for the results to display. 1.
View the FeNO result. If the result is less than 10 ppb, “< 10” will be displayed. If the result is greater than 200 ppb, “>200 ppb” will be displayed.
2.
Touch the Done button.
Remove Mouthpiece When the patient has completed performing a FeNO measurement: 1.
Remove the mouthpiece by firmly grasping around the outer diameter and twist counter-clockwise while pulling away from the handpiece.
2.
Properly dispose of the used mouthpiece.
3.
Replace the handpiece in its cradle on top of the device.
This can be done during analysis.
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IFU-3393 Rev G Instructions for Use, Fenom Pro
Chapter 6: Quality Control The quality control (QC) measurement is performed on a Fenom Pro device by qualified operators. QC Mode is designed to ensure the instrument is operating within its specifications. QC consists of two test types: a Negative Control, and a User Control. The Negative Control test begins with a standard breath maneuver, but analyzes ambient air that has been scrubbed of Nitric Oxide. The User Control test is performed by a Qualified User, and checks whether that user’s result is within 9 ppb from their median qualifying test. In order to be a Qualified user for User Control tests, a health care professional must first satisfy the following criteria: over 18 years of age, non-smoker, no known airway disease or chronic cold, preferably no allergies or asthma. That user must create a username for themselves, and then perform four User Control tests each separated by at least 12 hours. The first three tests determine whether this user qualifies: they must all be below 40 ppb, and the difference between the lowest and highest result must be less than 10 ppb. If these conditions are met, this user is qualified and their fourth test determines their QC User Status. Its result, and all future results for this user, are compared to the median result from the first three tests. If the first three tests do not meet the qualification criteria, this user is disqualified and a new user must be created.
Perform a QC Test 1. Touch the QUALITY CONTROL STATUS button from the Settings screen or the title bar at the top of the screen. 2. 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 selecting the NEW USER button and following the instructions in the Create QC User section of this chapter. 4. Once a user is selected, touch SELECT TEST button. 5. Follow the instructions in Chapter 5: Perform FeNO Measurement to perform a QC test NOTE: Each day, the system requires a valid User Control and Negative Control test. Any user can perform the Negative Control breath maneuver, since their breath sample is not being analyzed.
Device QC Status o
Passed - the most recent User Control test and Negative Control test were done within the past 24 hours, and both passed.
o
Failed - the most recent User Control test and Negative Control tests were done within the past 24 hours, but at least one of those tests failed.
o
Expired - No User Control test, or no Negative Control test, has been performed within the past 24 hours.
QC User Status NOTE: If a QC User result fails, then an alternative QC User should perform the QC Measurements to determine if the first QC User may have a changing condition or if the system may require service. If the 2nd QC User fails QC please contact customer support. o
Passed - latest test is within the expected range for this QC user.
o
Failed - latest test is outside the expected range for this QC user.
o
Expired - 24 hours or greater have elapsed since the last passing test for this QC user.
o
Insufficient Data - fewer than four tests have been performed for this QC user.
Create QC User 1.
Touch the NEW USER button from the SELECT USER FOR TEST window.
2.
Enter a USERNAME. The USERNAME may not contain spaces or match existing users.
3.
Touch the SAVE button.
IFU-3393 Rev G Instructions for Use, Fenom Pro
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Chapter 7: 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. Your device will only charge when ON.
To power off the device: 1.
Hold the POWER button down for at least 1 second.
2.
Touch OK on the confirmation window. NOTE: It is recommended to keep the Fenom Pro device connected to a power supply whenever possible when powered on.
Chapter 8: Practice Mode Practice mode is an option for use by a new patient in order to demonstrate the steps for performing a FeNO test. Results are not recorded in this mode. To access the Practice mode: 1.
On the Home screen, select the Start.
2.
Touch the Practice button.
3.
Attach a new, single-patient-use mouthpiece to the handpiece and review how to use the Fenom Pro device with the patient. (See Chapter 5: Perform FeNO Measurement for detailed instructions.)
4.
The patient inhales then begins exhaling into the mouthpiece for 10 seconds when ready.
5.
The patient stops exhaling once the countdown reaches 0 (zero).
6.
If training was successful, Good job! displays.
7.
If training was unsuccessful, Try again displays.
8.
Touch Repeat arrow to perform training again and go back to Step 4, or touch Done if finished to go back to the Home screen.
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IFU-3393 Rev G Instructions for Use, Fenom Pro
Chapter 9: Device Setup Initial Setup To set up the Fenom Pro device: 1.
Remove the device and power cable from the shipping package. NOTE: Retain all packaging for future transportation of the device.
2.
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. The second figure shows an improper breath tube connection.
Correct
Improper
3.
Once the breath tube is connected, place the 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 when the device is plugged in and powered on. NOTE: The device should be allowed to charge for at least 4 hours before operating on battery power. The device can operate normally while charging.
5.
Press the Power button to turn on the device.
6.
The Device Setup screen will display after powering on. From this screen, set the following device settings: o
Select Language
o
Set Time/Date
o
Add Tests (if applicable)
These settings can be accessed and changed at any time. 7.
The Fenom Pro is now ready to begin a test.
IFU-3393 Rev G Instructions for Use, Fenom Pro
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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 1.
The Settings button provides access to set the Time and Date, select Language, view System Info, select Test Incentive Sound level, and Add Tests (if applicable).
Time/Date 1.
Touch Time/Date on the Settings screen to set the date and time on the device.
2.
Use the + and - buttons to set the date and time.
3.
Touch the AM/PM button to toggle between values.
4.
Touch the Time Zone drop-down list and select the correct time zone.
Language 1.
Touch Language on the Settings screen.
2.
Select the desired language.
3.
A check mark next to the language indicates the selected language.
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IFU-3393 Rev G Instructions for Use, Fenom Pro
System Information 1.
Touch 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 1.
Touch Test Incentive Sound on the Settings screen to set the desired volume level, High, Low, or Off.
2.
A check mark indicates the current selection.
Add Tests (if applicable) 1.
Contact your distributor and ask for additional licensed tests for the Fenom Pro.
2.
Enter the code provided by the support representative and press Add Tests.
Note that “Add Tests” only applies to devices that show the triangle icon on the main screen.
Quality Control Status 1.
Touch Quality Control Status on the Settings screen.
2.
See Chapter 6 Quality Control for more instructions..
IFU-3393 Rev G Instructions for Use, Fenom Pro
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Chapter 10: 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 component.
Operating Conditions Ensure stable operating conditions by avoiding placement of the device in direct sunlight, near sources radiating heat, or ventilation. The device operates under the following conditions: o Temperature range of 15 to 30°C (59 to 86°F) o Atmospheric pressure range of 106 to 80 kPa o Relative humidity range of 20 to 80%, non-condensing o Use of the device below 20% relative humidity (RH) increases the risk of inaccurate scores. The device will issue a warning if the measured RH is ≤25% and prevent use if the measured RH is ≤20%.
Cleaning o Clean the external surfaces of the device with a cloth pre-moistened with 5% bleach solution at the end of each day of use. o DO NOT use spray detergents. o The following wipes are known to be compatible with Fenom Pro: Dispatch Hospital Cleaner with Bleach, Clorox Healthcare Bleach. o DO NOT use wipes that contain alcohol.
Handling o Take care while handling the device. o DO NOT drop the device or the handpiece. o Carry the device by placing fingers in the recessed handle on the back and placing thumb over the top of the device. Support the device from the bottom with other hand.
Storage o Clean the device before storing. o When not in use for an extended duration, store the device in its original packaging, including in the resealable bag with the humidity pack. Take care to not crush the humidity pack while storing the device. o Store the device in a location free from dust, free from excessive moisture or water splash, and away from excessive heat, cold, or dry conditions. o DO NOT store the device on tall or unstable surfaces. o Store mouthpieces in original, unbroken packaging.
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IFU-3393 Rev G Instructions for Use, Fenom Pro