NIOX FLEX Technical Manual sw ver 3.0.X Sept 2007

Table of contents Intended use . ... 2 Warning! ... 2 Caution! ... 3 Symbols ... 4 Installation... 5 NIOX® Flex receipt ... 5 Unpacking ... 5 Checking delivered equipment ... 6 Hardware installation ... 6 Connect NIOX Flex ... 8 External equipment installation... 8 Uninterrupted power supply (UPS) . ... 8 Connection... 9 Software set-up . ... 10 Date and time settings ... 10 Language and date format settings ... 10 Set password protected screensaver... 10 Database handling... 11 Backup... 11 Restore... 11 Export patient data... 11 Archive Patients... 12 Import Data... 12 Changing patient name ... 13 Import/export user profiles . ... 13 Import... 13 Export... 13 Set a header/footer on the print-out ... 13 Maintenance... 15 Maintenance reminder ... 15 Maintenance Guide settings... 15 Changing the fan filters . ... 15 Cleaning the NIOX Breathing Handle ... 16 Scheduled service ... 16

NO scrubber replacement ... 16 When to change the NO scrubber ... 16 Exchanging the NO scrubber . ... 17 Disposing of the used NO scrubber ... 18 Handling the LCD monitor ... 18 Enter Windows during start-up ... 18 Re-enter the NIOX Flex start-up process . ... 18 Troubleshooting ... 19 LCD monitor... 19 Service Mode ... 19 Enter service mode... 19 Change tolerances . ... 19 View log files... 20 Export log files... 20 Calibration... 22 Deadspace ... 23 Return of NIOX Flex ... 24 Preparations for packing... 24 Packing a complete system ... 25 Technical data... 27 LCD monitor technical data... 27 Standardization of exhaled NO measurements ... 28 FENO measurement criteria ... 28 Measurement technique ... 28 Patient factors1 . ... 29 References ... 30 Guidance and manufacturer’s declaration... 31 Electromagnetic emissions... 31 Electromagnetic immunity... 31 Recommended separation distances between portable and mobile RF communications equipment and NIOX Flex . ... 34

Technical Manual EPM-000069, version 02, September 2007, for systems with NIOX Software version 3.0.X. X can be any number between 0 and 9. The version number for your software can be seen in the Help – About screen. Information in this document is subject to change. Amendments will be made available by Aerocrine as they occur.



• NIOX® Flex is CE-marked according to Medical Device Directive MDD93/42/EEC and approved for clinical use in EEC countries. • NIOX Flex is cleared by FDA for clinical use in the USA according to 510(k) no: k021133. • NIOX Flex is ETL-Classified according to General Requirements for Safety (CAN/ CSA-C22.2 No. 601.1) and (UL-60601-1) • Copyright © 2007 Aerocrine AB, Solna, Sweden. • NIOX is a registered trademark of Aerocrine AB. • Windows XP® is a registered trademark of Microsoft Corporation.

Intended use Please refer to the chapter ”Intended Use” in the NIOX Flex Daily Use Manual.

Warning! Indicates that an accident may occur if the precautions stated under the heading are not taken. The accident may be fatal or cause injuries to human beings or may create essential damage to the product. • NIOX Flex Nitric Oxide Monitoring System unit must always be used and handled as stated in this manual. Aerocrine accepts no responsibility for damaged equipment or faulty results, if the equipment is not handled according to this manual. • The equipment is not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide. • Parts of the equipment are still supplied even when NIOX Flex is shut down. To power off NIOX Flex completely, withdraw the mains plug. • NIOX Flex contains an ozone generator. The maximum leakage is set below hazardous levels. If a any point the leakage should exceed given limits, the system will shut down automatically. Do not restart. Contact support personnel immediately. • Only Aerocrine or their appointed organizations or specially trained personnel may perform technical maintenance. The device warranty does not apply, if anyone other makes attempts to open or in any way dismantle NIOX Flex. • External equipment intended for connection to signal input, signal output or other connectors, shall comply with relevant IEC standard (e.g. IEC 60950 for IT equipment and IEC 60601 series for medical electrical equipment). In addition, all such combinations – systems – shall comply with the standard IEC 60601-11, Safety Requirements for medical electrical systems. Equipment not complying to IEC 60601 shall be kept outside the patient environment, at least 1.5 m from the patient or the patient support. • Any person who connects external equipment to signal input, signal output or other connectors has formed a system and is therefore responsible for the system to comply with the requirements of IEC 60601-1-1. If in doubt, contact a qualified technician, or your local Aerocrine representative.



• Always read accompanying product documentation before handling gas cylinders and valves. Always check applicable protocols at your clinic before handling. • Never restore data without first contacting support personnel. If you restore data with a database backup older than the existing database, it will write over the existing data with old data. • Handling of NIOX® Flex must be performed by personnel who have attended the Aerocrine NIOX Flex System Training Program or NIOX Flex Support Training Program. • Use only cables supplied with NIOX Flex for connection, (power cable, monitor signal cable, monitor power cable and network cable [LAN]).

Caution! Indicates that malfunction of the product may occur if the precautions stated under the heading are not taken. • Ensure that a NIOX Filter is attached to the NIOX Breathing Handle at all times. • Do not place any electrical and/or magnetic equipment closer than 1.5 meters to NIOX Flex as this may influence the measurements and cause incorrect test results. • Do not use any cellular or other portable phones near NIOX Flex as this may influence the measurements and cause incorrect results. • Ensure to wipe off the ventilation grids at regular intervals and change fan filters monthly. • Never start NIOX Flex until all steps in the chapters "Hardware installation" and "Connect NIOX Flex" have been completed. • Do not immerse any parts of the device in water or any other liquids. • Do not cover ventilation grids at the back of the main unit. Ensure that there is at least 0.5 meter free space between the ventilation grids and the wall. • Do not touch the ozone scrubber behind the maintenance hatch. • Data- and system errors may occur if system is not correctly shut down. • Keep the monitor away from overly hot, cold or humid places, places directly under sunlight, dusty surroundings, and equipment that generate strong magnetic fields. • Place the monitor in a well-ventilated place, and on a flat and leveled surface. • Do not insert sharp objects or spill liquid into the LCD monitor through the cabinet slots. This may cause accident fire, electric shock, or failure. • Do not cover or block the monitor vent holes. • Always backup the NIOX Flex data before repair or scheduled service. The user is responsible for performing a backup copy of the patient data before the device is picked up. Back up of data should always be performed to separate media, e.g to a network server or a USB memory stick.



• Daily maintenance and preventive inspections must be performed by properly trained personnel. • Each customer carries the sole responsibility for data in the patient database. If the data has been changed after exportation from NIOX® Flex. Aerocrine does not assume responsibility. • It is recommended to manually initiate self test (OptionsPerform Self Test) after every third measurement in Research Mode. • It is necessary to recalibrate the system, if the operating temperature deviates more than ±5ºC from the operating temperature at time of calibration. • The sampling tube can only be removed and reassembled 10 times before it must be replaced with a new sampling tube. The edge of the tube may release plastic pieces that may clog the sampling inlet and seriously damage the NIOX Flex. The warranty does not apply if the sampling tube has been frequently removed and assembled. • Keep the transportation package for shipment to service and repair if needed. If shipped in other packages the device warranty does not apply. • Always remove the NIOX Filter from the Breathing Handle, do not pack it with the NIOX Flex system.

Symbols The product should be recycled according to the local regulations for electronic equipment. Refer to Correct disposal of this product in Daily Use Manual The equipment meets the requirements of all applicable European directives Carefully read the Technical Manual and Daily Use Manual before starting the system ETL-Classified according to General Requirements for Safety (CAN/CSA-C22.2 No. 601.1) and (UL-60601-1)



Type B applied part 100–240 V ~ 50–60 Hz 2A For single use only

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Certified according to EN/IEC 60601-1 by Intertek-SEMKO Intertek-SEMKO’s number as a Notified Body Fuse type: T5 AL 250 V

Installation NIOX® Flex receipt Warning! Handling of NIOX Flex must be performed by personnel who have attended the Aerocrine NIOX Flex System Training Program or NIOX Flex Support Training Program. Before signing transport documents, make sure that the goods have not been damaged during transportation. If the package has been damaged or turned in any other way than with the right side up and the wooden pallet at the bottom, do the following: 1. Describe the damage on the waybill. 2. Let the driver sign the waybill. 3. Document the damage in any other way, with a photograph if possible. 4. Send a copy of the signed waybill and a photograph to the local Aerocrine representative.

Unpacking 1. Unfasten and remove the straps around the container and lift the hood off. 2. Remove the plastic protecting the container. 3. Take out the boxes and support cushions inside and open up the boxes. 4. Save all the packing material, including plastic bags, for later use/resending. The original packing material is needed for warranty shipment. Note! Please, report any damage immediately to the local Aerocrine representative and the transportation company involved.



Checking delivered equipment Carefully check the packing list enclosed with NIOX® Flex and tick off the different articles. A standard shipment includes the following: • NIOX Flex Main Unit (1) • NIOX Breathing Handle including: Sam(2) (1) pling Tube and Breathing Tube (2) • NIOX Flex User Interface, including: Keyboard with Keyboard Cable, Monitor with Monitor Power Cable (3 m) and Monitor Signal Cable (3) • NIOX Filter, pkg/50 (4) (4) • NIOX Flow Control, 50 ml/s (5) • Calibration Tube (3) • Sampling Tube (5) • PC Mouse • Three Power Cables: EU (2 m), GB (2 m), US (1.8 m) • Network Cable (LAN) (3 m) Optional items: • Network Cable Crossover (3 m) • Dummy NIOX Breathing Handle (for demonstration purpose only) Note! If any device listed above is missing or damaged, immediately contact your local Aerocrine representative.

Hardware installation 1. Place the User Interface on a desk or similar working area. 2. Place the NIOX Flex Main Unit on the floor e.g. under the desk, on a table or on a cart table. Caution! • Do not place any electrical and/or magnetic equipment closer than 1.5 meters to NIOX Flex as this may influence the measurements and cause incorrect test results. • Do not cover ventilation grids at the back of the main unit. Ensure that there is at least 0.5 meter free space between the ventilation grids and the wall.



(A) 3. Attach the sampling tube to the sampling tube connector, and the breathing tube to the breathing tube connector on the main unit. The sampling tube has a bayonet connector (A). Ensure that the sampling tube has a clean cut end and is inserted competely into the connector until it cannot be pushed in any further.

4. Open the service hatch on the front of the main unit.

(B) 5. Release the top of the Y-piece (B) by gently pulling it down.

(C)

6. Insert the NIOX® Flow Control (C). Do not turn or twist. 7. Reattach the Y-piece. 8. Close the service hatch.



Connect NIOX® Flex External equipment installation Warning! • External equipment intended for connection to signal input, output or other connectors shall comply with relevant IEC standard (e.g. IEC 60950 for IT equipment and IEC 60601 series for medical electrical equipment). In addition, all such combinations – systems – shall comply with the standard IEC 60601-1-1, Safety Requirements for medical electrical systems. Equipment not complying with IEC 60601 shall be kept outside the patient environment, that is at least 1.5 m from the patient or the patient support. • Any person who connects external equipment to signal input, output or other connectors has formed a system and is therefore responsible for the system to comply with the requirements of IEC 60601-1-1. If in doubt, contact a qualified technician, your local representative or Aerocrine. Contact Aerocrine for information regarding different equipment, verified by Aerocrine to work with NIOX Flex.

Uninterrupted power supply (UPS) If NIOX Flex is connected to an electrical environment, where spikes or power failures are common, it is strongly recommended to use an external backup battery with a power surge protection function, i.e. an Uninterrupted Power Supply (UPS). Note! The UPS must not require any software to be installed on NIOX Flex for monitoring and controlling the UPS. NIOX Flex has a power consumption of maximum 2 A. A UPS with a minimum capacity of 1000 W will keep NIOX Flex and printer running for approximately five minutes. NIOX Flex is delivered with three different power cables, use the one that suites the electrical outlet in your country. When ordering a UPS, make sure that the voltage for the power cable is correct, e.g. 100–240 V. For installation follow the instructions delivered with the UPS regarding charging and connection.



Connection Warning! Use only cables supplied with NIOX® Flex for connection, (power cable, monitor signal cable, monitor power cable and network cable [LAN]). 1. Connect the monitor signal cable (A) and the monitor power cable (B) to the connectors on the main unit. 2. Connect the monitor power cable and the monitor signal cable to the NIOX Flex User Interface. The connectors are located on the bottom side of the monitor, on the lower left hand side.

(B) (E) (D) (C) (A)

3. Connect the keyboard cable (C) and the mouse cable (D) to the connector on the main unit. 4. If using a printer, connect the printer. Please refer to the manual delivered with the printer regarding connection. 5. If using NIOX Flex in a network, connect the network cable (LAN) to the network connector (E) on the main unit and to the network provision.

(F)

6. Connect the power cable to the connector (F) on the back of the main unit. 7. Attach a new NIOX Filter to the NIOX Breathing Handle. Note! For information on start-up, calibration, and use, please refer to the Daily Use Manual.



Software set-up Date and time settings Note! • Contact local support or system administrator before changing date or time in the system. • When opening the NIOX® Software from Windows the waiting time is four (4) hours before calibration and use of the system. 1. Select Options – Configuration – Windows Settings. 2. Click OK. 3. Click the Start menu at the bottom of the screen and select Control Panel. 4. In the Control Panel, right-click the Date/Time icon and select Open. 5. Adjust date and time according to your geographic position and time zone 6. Click OK. 7. On the Windows desktop, right-click on the NIOX Flex icon and select Open. 8. Refer to step 2-7 in the start-up section of the Daily Use Manual.

Language and date format settings 1. Select Options – Configuration – Language Settings. 2. Select language. 3. Select date format. 4. Click OK.

Set password protected screensaver 1. Select Options – Configuration – Windows Settings. 2. Click OK. 3. Click the Start menu at the bottom of the screen and select Control Panel. 4. In the Control Panel screen, right-click the Display icon and select Open. 5. Click the Screen Saver tab. 6. In the Screen saver frame mark the box On resume, password protect Note! The default user on NIOX Flex is: Niox The default password on NIOX Flex is: nioxflex

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Database handling Measurements are saved in a Microsoft Access database in NIOX® Flex. The patient data in the database is sorted according to a Patient ID with a maximum of 40 characters (letters and numbers). The Patient ID is entered in the Enter Patient Information screen (Patient – New Patient). In case a loaner NIOX Flex is used when the original NIOX Flex is sent for service, the original database should be backed up and restored in the loaner for continued use. When the original NIOX Flex is returned, the complete database should be backed up from the loaner and restored in the original NIOX Flex again. For additional information on how to move data between a NIOX Flex and a loaner NIOX Flex please contact your local Aerocrine representative. The backed up data is stored in a folder named Backup followed by the date and time of the backup e.g Backup2006-10-02 15-25-23. That folder contains another folder named Test parameters which includes the User profiles from different modes.

Backup A backup is performed to obtain a copy of the complete database file. The backup file is for the restoration of data in case of unforeseable damage to the file or moving the database between NIOX Flex systems. Note! Daily database backups are recommended. Always perform backup before service. Each customer carries the sole responsibility to perform a backup copy of the patient data. Refer to Daily Use Manual for back up data instructions

Restore Warning! Never restore data without first contacting support personnel. If you restore data with a database backup older than the existing database, it will write over the existing data with old data. Restoring data means exchanging the complete existing NIOX Flex database with an older backup copy. 1. Select Options – Backup – Restore Data. 2. Select backup directory. 3. Click Restore.

Export patient data When exporting patient data the information will be copied from the database. No data will be removed. To remove data please refer to Archive Patients 1. Select File – Export Data 2. Use the parameters in the drop-down lists as a query filter along with the date interval. Click Search to sort out the data to export.

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3. Select data to export by clicking the appropriate row. (To select more than one row press the Ctrl key at the same time as clicking the rows) alternatively click the Select All button 4. Choose to Export to TAB delimited text file or Export to XML file with the radio buttons 5. Click Export 6. Choose destination for the exported data 7. Enter a file name for the exported data in the New File Name field. 8. Click Select. Note! When exporting to an XML file all curve data from the graphs will be included . When exporting to a TAB delimited text file only the average FENO-, VNOand Flow values will be included

Archive Patients When archiving a Patient file the data will be removed from the database and saved in a default destination folder. Archived Patient files can later be retrieved from this folder, from File – Import. Note! • Only complete Patient files can be archived • An active Patient cannot be archived • All archived Patient files are saved in XML format with an ‘.arc’ suffix 1. Select File – Archive Data 2. Use the parameters in the drop-down lists as a query filter along with the date interval. Click Search to sort out the Patient files to export. 3. Select Patient to archive by clicking the appropriate row. (To select more than one Patient press the Ctrl key at the same time as clicking the rows) alternatively click the Select All button 4. Click Archive 5. Choose destination for the archived Patient file and click Select. (It is recommended to archive the Patient files in the Archived Patients folder which is set as default.) 6. Enter a file name for the exported data in the New File Name field. 7. Click Select.

Import Data 1. Select File – Import Data 2. Select the source directory from where to import Exported or Archived Data 3. Select the data to import

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4. Click Import Note! • It is not possible import Patients with the same Patient ID that already exists in the database • Only exported or archived files with a .xml or .arc suffix may be imported

Changing patient name To change or correct misspelling of existing names of patient early tested and stored in the NIOX® Flex system, without changing or altering any of the Clinical Data: 1. Select Patient – New Patient 2. In the "Enter Patient Information" screen, enter the existing Patient’s ID Number and press the TAB key once. 3. Select the name by highlighting the name and type in the new name. 4. Press the TAB key once. 5. Enter examiner name or initials and press OK. 6. Click Yes.

Import/export user profiles Import 1. Select Options – Test Settings. 2. Click Import/Export User Profile. 3. Select a folder from which the User Profiles will be imported, in the right field. 4. Select the User Profiles to import. 5. Click Import.

Export 1. Select Options – Test Settings. 2. Click Import/Export User Profile. 3. Select the User Profiles to export from the left field. 4. Select a destination for the User Profiles in the right field. 5. Click Export.

Set a header/footer on the print-out 1. Select to print according to Daily Use Manual 2. In the Report Parameters screen click the Select Header or Select Footer button. 3. Select a folder with images from the destination list 4. Click on the image name to view the image

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5. Click the Select button To remove a chosen image and leave the header/footer space blank mark the Select No Image box then click the Select button Note! • The header/footer image needs to have a .gif, .jpg or a .bmp suffix. • The maximum size of the header/footer image is 700 (width) x 100 (height) pixels

Printed report with graphs Example of a printed report with graphs. Space for header

Space for footer

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Maintenance Maintenance reminder Maintenance Guide settings 1. Select Options – Configuration – Maintenance Guide. 2. Choose options to be notified by checking the check boxes. 3. Enter information in the appropriate text fields. A) The gas reminders will notify when the shelf life time has expired. See gas certificate attached to the gas cylinder for data B) Notify time to order NO-Scrubber – 5 months after last replacement. C) Notify time to order 18 Months’ Scheduled Service – 15 months after latest service D) Prompt weekly for backup (every Friday). E) Prompt monthly for fan filter exchange.

A)

B) C) D) E)

Changing the fan filters (Aerocrine article number 02-4638) To prevent too high cabinet temperature due to clogged fan filters Aerocrine recommend to change the fan filters once a month. 1. Grab the filter covers and pull them gently to remove. 2. Remove and discard the old fan filters. 3. Insert one (1) new filter in each retainer. 4. Replace the filter covers. Note! Remember to change both the upper and lower filter on the rear side of the unit

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Cleaning the NIOX® Breathing Handle Note! The sampling tube can not be removed and reassembled more than 10 times before it must be replaced with a new sampling tube. 1. Shut down NIOX Flex, refer to the Daily Use Manual. 2. Remove the breathing tube from the NIOX Breathing Handle. 3. Remove the handle from the sampling tube. Press a long screwdriver against the connector (A) inside the handle and pull on the sampling tube (B). 4. Clean the NIOX Breathing Handle by immersing it into ethanol solution or mild detergent.

(A) (B)

5. Wait until the NIOX Breathing Handle is dry. 6. Ensure that the sampling tube has a clear cut end and insert it to the bottom. 7. Start up NIOX Flex, refer to the Daily Use Manual.

Scheduled service To maintain uninterrupted operation, all NIOX Flex systems must undergo service, when functions and major parts are tested, and if necessary exchanged. This service should be performed after 18 months from the date of start-up and installation. Contact the local Aerocrine distributor for more information. Note! Aerocrine takes no responsibility for the performance of NIOX Flex if the scheduled service is not performend at regular 18 months interval.

NO scrubber replacement The NIOX NO scrubber (article number 02-1508) needs replacement when used more than 4 300 hours or every six months.

When to change the NO scrubber 1. In Clinical Mode, select Mode – Service Mode – Service Mode. 2. Type the password zenon and click OK. 3. Select Options – View Operation Log. 4. Locate the three parameters “Accumulated ON time for the NO filter”, “Date of last NO filter change” and “Accumulated System On time”. 5. If the values complies with the following criteria, the NO scrubber needs to be exchanged: • either “Accumulated ON time for the NO filter” > 4 300 h

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• or “Date of last NO filter change” > 6 months and “Accumulated system ON time” > 4 300 h 6. Click Close and then Exit to leave Service Mode.

Exchanging the NO scrubber 1. Carefully unpack the new NO Scrubber. Inspect for any transportation damages. Please, report any damage immediately to the local Aerocrine representative. 2. Remove the two plastic plugs, one on each side of the NO Scrubber. 3. Select Options – Backup – Backup Data. Select destination directory D:, or any other destinations except C: and click Backup. 4. Select File – Shut Down and click OK. 5. Unplug the mains power cable 6. Remove the service hatch.

7. Loosen and remove the old NO Scrubber by turning it counter clockwise.

8. Replace the old NO scrubber with the new one. Keep the NO scrubber straight and tighten it firmly by turning it clockwise. 9. Put the service hatch back in place. 10.Insert the mains power cable into the mains inlet and turn the system on by using the on-button. 11.Click the OK button in the NIOX Flex Start-up screen to start the software and to warm up the system. 12.Enter Clinical Mode without performing a calibration. 13.In Clinical Mode enter Service Mode and type the password zenon. 14.Select File – Unlock and enter the password nofilter.

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15.In section Component change in the upper right hand corner, check the new NO filter box and click Update logging. 16.Click Exit. 17.You have now completed the NO Scrubber exchange.

Disposing of the used NO scrubber NO Scrubbers are to be disposed of in accordance with the applicable local waste disposal regulations. Appropriate information can be obtained from the pertinent local authorities.

Handling the LCD monitor On the front of the screen, there are five buttons and an indicator. Their functions are, from the left to the right: [–] Adjust the decreasing value of the selected OSD control option. [+] Adjust the increasing value of the selected OSD option. [Power Switch] Turn the display system power on or off. [Arrow pointing down] Activate the pop-up menu on the screen, and select direction “down” while scrolling through the options. [Arrow pointing up] Activate the pop-up menu on the screen, and select direction “up” while scrolling through the options. [Power indicator] Indicates status when the unit operates in different modes.

Enter Windows during start-up 1. Turn on NIOX® Flex using the on-button on the rear side of the main unit 2. When the NIOX Flex start-up screen appears press Esc and Q on the keyboard 3. Click OK in the alert screen

Re-enter the NIOX Flex start-up process 1. On the Windows desktop, right-click on the NIOX Flex icon and select Open 2. Refer to step 2-7 in the start-up section of the Daily Use Manual

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Troubleshooting LCD monitor Fault

Action

Monitor does not respond after the system is turned on.

Check that the power is turned on. Turn off the power and check the monitor’s power cable and signal cable for proper connection.

The characters on the screen are dim.

Refer to Maintenence – LCD monitor to adjust the brightness.

The screen is blank.

During operation, the monitor screen may automatically turn off as a result of the power saving feature. Press any key to see if the screen comes back. If it does not, refer to Maintenence – LCD monitor to adjust the brightness.

The screen flashes when it is initialized.

Turn off the monitor and turn it on again.

Patient files cannot be imported/exported 1. Insert a USB memory stick in one of the USB slots and try again. 2. If files to be imported are located on the network, make sure the correct path is provided and make sure the network is running. 3. Patient files with the same ID as one already registered in the database cannot be imported.

Service Mode Enter service mode 1. Select Mode – Service Mode – Service mode 2. Enter password 'zenon' and click OK

Change tolerances Note! Only with guidance from service personnel, and using another password, the parameter tolerances in Service Mode can be changed. The table below presents the tolerated minimum and maximum values: Parameter

Range

Actual PMT HV [V]

620–720

RC temperature [C]

38.5–41.5

RC pressure [V]

0.55–0.95

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