NIOX Patient User Manual US.book
Contents
1. Patient Information Date of Birth Physician Patient ID Number Se fam Female Measurement Length Upper Limit Lower Limit 2 Select the relevant text fields and enter information Note Mandatory information Patient ID must be unique Select physician from the drop down list 4 Optional Set upper and lower limits for the patient s FeNO value by entering the limits in the text fields It is also possible to change the limits in the graph 5 Select Save to return to the NIOX Patient view Cancel leaves the view without saving changes 0008 18 02 NIOX Patient User Manual US Search for a patient oa NIOX Patient A N Type in search field for patient journals First Name Last Name Patient ID PHYS e Gender Co ane Doe 500804 7420 2011 11 03 Female Tatiana Durechova 6852216338 2012 04 17 Female Create New Patient uraj Dzima JUDr 8003218003 2012 04 25 Male ulio Fernandez 56749 Male Lucia Filova Ing 8255157999 2012 04 25 Female udmila Galbav 466011747 2012 04 18 Female ana G likov 6456246071 2012 04 23 Female M ria Gondov 445202162 2012 04 24 Female Kamil Gur n 411227714 2012 04 23 Male Dagmara Herbulakova Pharm 8352218017 2012 04 23 Female Patrik Hires 7202267512 2012 04 20 Male ubica Hy kov Ing 6651257030 2012 04 27 Female Helena Jur kov 475922759 Female pavol kabzan 8401317628 Chiesi 2012 04 13 Undefined If not already open open the filter panel2. 1 22 2014 11 58 AM Create Report had an approved daily QC measurement 2 In the filter panel it is possible to Note Instruments marked with a check mark are quality controlled and ready for use e Narrow the log list range by entering interval dates Enter starting date in the top row and ending date in the bottom row 25 Chapter 6 NIOX QC 6 3 1 Export or print QC logs l Choose Create Report and select Quick print or QC Report Quick Print prints what is visible on the screen Export QC Report creates a Word file which allows for further editing Example of report QO NIOX QC Instrument report Instrument NIOX MINO 24263 Report start date 2012 06 18 Report end date 2014 11 20 The following QC measurements are performed for the instrument D Instrument NO value U equence Status Rumoer zore rz 1240 Daily OC Not Passed _2TETTTT 7006 Daily QC Passed rene 7437 Daily GC Not Passed anene 077 Day GCNot Passed i 3 ing j oenn ow Dally OC Not Passed AT aiping O ACANA Daly OC Not Passed 143g rt menm 7825 Daly OC Not Passed a r oatiying 183 Daily OC Not Passed 1 focuser FQ yg ft raora roe Daily GC Not Passed s focuser Og m Ocus Qualified Daily OG Passed acusen Oee 8 erer oss Daily OC Not Passed 17 OCs S Cuad 6r Z012 1047 Daily QC Not Passed 15 OC User Qualified 201212 WHT Daily QC Not Passed 7 OC Use
3. AFA NIOS FUEN ea a e serene taluce nn els ate tude 9 A DGC ALE MCW palen al Genet pone aa T OOT 11 AD oea R Ora palen esra ea EA E tune 11 4A Opel a Paen OUNIA ona eri es aed 12 4 5 Make changes to an opened patient reCOrd ceeceeeeeeeees 13 AGO Alle Nole 2 os zi ier Reena s Oh E a 14 47 Manage MCASUTCINCINS noron i andek eia sasha de mavenshocme unseen 15 4 0 Chale a report OF a Joumal saksnr 16 4 9 Automatic import of measurements from NIOX Panel 17 NIOX Patient User Manual US 0008 18 02 DINIOX AQMD cccvecsutess doosssuteseesuceioaus ie reoi NN 17 Ikat NOK AGN esias e e a T a 18 D ANTOK U STS E A TT 18 Ded Crelle NOW USED anar n a a yes bexaueussMeueenunaaereest 19 5 4 C stomize patient JoU alS onenn a a 20 PEE e T E etl A E E E E 22 KODIDA GS CUD eretic Petre dul macnnti E anc tieeeren tl canna saad 22 Dl CDG NG OIG EEEE iene gaat ences ena non ats casas oe oa ae need aca 24 BINION OG eres aces sees a A a ease cti ds achat 24 Ox Staten OK OC aaie Rice ign watean T EAE A semanas coed 25 6 2 View instrument QC STATUS seictinres otitis ii ceaeha ee eareeenee 25 6 3 VIEW instrument O 1026 araia E 25 Chapter 1 Important information 1 Important information 1 1 Before using NIOX Patient NIOX Patient should only be operated as directed in this manual by trained healthcare professionals Trained status is achieved only after care ful reading of this manual Read the entire instructions for use and ma
4. All Import Selected Cancel Built in report 1 Built in report 2 3 Scroll the list for the measurements to import Select the row s with the measurement s to include in the import The selected row s will be highlighted 5 Select Import Selected to start importing and return to the opened patient Journal view Cancel returns to the opened patient Journal view without importing any measurements Create Report Note In case a measurement is imported to the wrong patient Journal it is possible to delete the measurement from the patient Journal and make it available for reimporting to the correct patient Journal e Quick print Prints the content shown on the screen e Built in report 1 or Custom report 1 Creates a Word file which allows for further editing e Select the faulty imported measurement from the Patient journal e Built in report 2 or Custom report 2 Creates a Word file which measurement list or select it in the graph Then slide the Delete allows for further editing button to display Yes To save changes select Save 2 After saving printing you will return to the opened patient Journal view e To build a customized report start with either PatientReport1 doc or 16 000818 02 NIOX Patient User Manual US Chapter 5 NIOX Admin PatientReport2 doc and save the document with a new name e To load the customized report use NIOX Admin Customize reports on page 21 e To create a completely customized repor
5. CS database NIOX QC Select users or instrument log 1 Select an instrument This opens the QC log view displaying the instrument ID and QC logs e Scroll using the vertical bar to see the entire list Ov 6 e2 Oo aE 030800412 030800398 031100714 24263 NIOX OG In Sou ment log NIOX MINO 24263 Date amp Time Status Status ppb Number 1 22 2014 12 40PM Daily QC Not Passed QC _Userl Qualifying lt 5 510 9 22 2014 10 03AM Daily QC Passed 4 Qualified 14 152 9 22 2014 9 55AM Daily QC Passed 4 Qualified 15 151 9 19 2014 9 55AM Daily QC Not Passed 4 Qualifying 16 149 9 18 2014 1 10PM Daily QC Not Passed 2 Qualifying 14 148 9 18 2014 12 38PM Daily QC Not Passed 4 Qualifying 15 147 9 18 2014 12 33PM Daily QC Not Passed a Qualifying 16 146 9 16 2014 3 00PM Daily QC Not Passed a Qualifying 13 145 9 16 2014 2 19PM Daily QC Not Passed 4 Qualifying 15 144 9 16 2014 2 11PM Daily QC Not Passed 3 Qualifying 15 143 9 16 2014 2 02PM Daily QC Not Passed 2 Qualifying 16 142 9 15 2014 2 22PM Daily QC Not Passed 3 Qualifying 13 141 9 15 2014 2 12PM Daily QC Not Passed 2 Qualifying 11 140 9 15 2014 2 04PM Daily QC Not Passed 1 Qualifying 14 139 9 15 2014 1 51PM Daily QC Not Passed a Qualifying 14 138 m m 1 22 2014 12 14PM Daily QC Not Passed QC_Userl Qualifying 14 71 6 n 2 Vi ew l n st ru m e nt QC stat u S Daily QC Not Passed QC_User1 Qualifying 14 70 In the NIOX QC start view it is easy to verify which of the instruments has V
6. NIQX Admin Database Setup Current Mode Local Database Single user SQL CE Restore DM Database Point out the location of the DataManagement backup le to restore Restore Database Point out the location of the backup file No Restore done Clear Database This will erase all data from the database No Clear done When restoration of the database is complete the button changes to Back up database NIOX Admin Database Setup Current Mode Local Database Single user SQL CE Backup Database Point out the location where to save the backup file No Backup taken Restore Database Point out the location of the backup file No Restore done Clear Database This will erase all data from the database Last Cleared 6Days ago For network database contact the network administrator Aerocrine rec ommends creating a new single user database importing as described above exporting SQL CE definitions and data to a SQL script and running the script on the SQL Server 3 5 Set NIOX administrator privileges the first time The system comes with a default administrator account in NIOX Admin 1 Select the Ad icon on the start menu This opens the NIOX Admin application 2 Select NIOX User This opens the NIOX User view 3 Log in as User name a Password p 0008 18 02 NIOX Patient User Manual US Chapter 4 NIOX Patient 4 Select the user from the list and set a new user name opti
7. button opens the Edit Patient Details view Refer to Edit patient details on page 13 for details e Journal Notes displays the number of available Journal notes and the latest note and date in full Selecting this button opens the Journal Notes view Refer to View Journal note on page 14 for details 12 e Import Measurement from Database Selecting this button allows for adding measurements to the patient Journal Refer to Import measurements to a Journal on page 15 for details Manually Create Measurement Select this button to manually enter measurement details Refer to page 15 for details In the bottom search bar there are also options Show measurement mode Select any option to display of the available measurement modes by clicking on it Select the date time range displayed in the Journal by entering time intervals in the search field select the arrow down button and set year month day The interval starting time is entered in the top row and ending time in the bottom row Select how to display the measurements To show the graph slide the Graph slide button to the right The text beside the button will display Graph ON To display the view without showing the graph slide the Graph slide button to the left The text beside the button will display Graph OFF NIOX Patient Journal Sven Eric Aberg December 23 1948 7 QNA 4812232751 om So om Gey O A Dr Tester Journal Not
8. by setting the Show users that are slide button to Inactive 2 The results matching the search will be presented in the list Note Scroll using the vertical bar to view all information in the search result list 5 3 2 Edit user 1 Select a user from the list This opens the Edit User view 2 Edit the relevant information by selecting the text box and enter the new information using the keyboard e Set privileges by selecting the relevant check box A check marked box gives the user access to the application vi e To remove privileges uncheck the check box e Set the user status by setting User Status button to display Active or Inactive 3 Select Save to save the changes and return to the NIOX Users view Cancel leaves the view without saving changes 5 3 3 Set global account rules Global account setting regulate the general rules on password usage and account duration for all users included in the system Setting or changing global account rules requires administrator privileges Note Administrator accounts never expires 19 Chapter 5 NIOX Admin 1 Select Account settings This opens the Global Account Settings view NIOX Admin Global Account Settings Password Required Yes pma No lale Duration Minimum number of Characters 6 v Account Expires No i 1 Days v Strong Password Required A strong password must contain at least one 1 of each upper case letter ABC lower case letter
9. NIOX Patient User Manual NIOX Patient Journal ae Linda Miller Mars 05 1985 Doctor Smith ppb 3 ia r a px ee A Create Manually Create Journal Note Measurement TIMESTAMP NO ppb COMMENT SIGNATURE 2014 09 19 13 42 15 e 2014 09 12 08 05 23 year 2014 08 21 12 51 15 Measurement from 2014 07 01 16 02 19 Database 2014 04 23 15 44 13 2014 01 24 15 45 29 2014 01 13 14 43 20 v 2013 12 13 14 24 12 2012 v November vi 18 V GRAPH On al Q Measurement Mode 2014 September v v Limits Off al Create Report 10 seconds NIOX Patient User Manual US 0008 18 02 EPM 000225 Table of contents 1 Important informa hoM vss ssescsccbessecves tes evens sevec SS 3 ll Berre usine NIOK PRENE cren nn eae S 3 KADOU STANU eia AN 3 LFC ONDIN O NN 3 1 4 Responsible manufacturer and contacts 1sseeeeeeeeeeeeeeeeeeees 3 PINARIN OS seis eE a E E T 3 LOINENdEO USET uraian E N 4 2 Product description oecon E E 4 ANON PaT ON ee eee r E T T eee 4 3 Installation and setup isvessscssvsessassccesrsanasndesasascaewuadewetesesnsnscevenseadess 5 SA che TOO UNC TIVC INES iiss cesaerac scan O 5 PR o AW AU OW TET E satel NE alice bie E EN E T 5 B D Database setU ranna e EE TEA N 7 DA server regquremen raean a E 7 3 5 Set NIOX administrator privileges the first time 0000000000000000 8 3 6 Installation of NIOX Database on SQL Servel 0eeee 9 A NIOX Pafient oinin anaa e A R 9
10. abc digit 123 2 Slide the button Password required to show Yes or No If password is not required then go to step 6 below 3 Select the arrow down button and select a number for the minimum numbers of characters for the required password 4 Slide the button Strong password to show Yes or No Slide the button Account expires to show Yes or No 6 Select the arrow down button and select values for the account duration Select Save to save the changes and return to the NIOX Admin Users amp Settings view Cancel leaves the view without saving changes 5 4 Customize patient Journals This option enables NIOX Users to customize patient Journals and Re ports 5 4 1 Custom fields To add custom fields to patient Journals 1 Select Report amp Setup in the NIOX Admin view This opens the Customization view NIOX Admin Customization Custom Customize Content Fields In Reports ae 2 3 4 Oe 5 Display Patient Name 2 Select a custom field and enter the title of the custom field to appear on the patient Journal Repeat to add more fields 3 Slide the button next to the relevant custom field to show On for it to be displayed 4 Slide the button Display patient name to show On for it to be displayed 20 Chapter 5 NIOX Admin 5 4 2 Customize content in reports The report is created in open xml standard and is available in word format The relevant information in the patient journal is sho
11. ally collected even if they are performed on several different in struments 2 1 1 NIOX Panel NIOX Panel is described in the NIOX VERO User Manual and a separate user manual for NIOX MINO NIOX Panel is a visual aid that allows the user to operate the instrument from a PC and store measurements in the database 0008 18 02 NIOX Patient User Manual US Chapter 3 Installation and setup 3 Installation and setup 3 1 PC requirements Operating systems e Windows 7 32 or 64 bit e Windows 8 1 Pro 32 or 64 bit Supported screen resolutions e 1024x768 e 1366x768 e 1280x800 e 1920x1080 3 2 Installation 1 Select the file setup exe in the installation folder 0008 18 02 NIOX Patient User Manual US 2 An installation wizard opens accept license agreement 3 NIOX Apps Setup Please read the NIOX Apps License Agreement License Agreement NIOX Apps Software This is a License Agreement Agreement between you the Licensee and Aerocrine AB the Licensor regarding the NIOX hoon Software the Software and any upgrades thereof ATTENTION PLEASE READ THIS DOCUMENT CAREFULLY BEFORE CLICKING ON THE I ACCEPT BUTTON IN THE INSTALLATION PROGRAM BY PRESSING I ACCEPT THE LICENSEE ACKNOWLEDGES TO HAVE READ THIS AGREEMENT AND AGREES TO BE BOUND BY ITS TERMS AND CONDITIONS IF THE LICFNSFF NOFS NOT AGRFF TO THF TFRMS OF THIS E I accept the terms in the Licen
12. and restore functions Note In a Multi User setup the backup is performed by the network administrator and there is no option to clear database 22 Chapter 5 NIOX Admin Note The setup can be changed later Refer to the Database setup on page 7 for details 5 6 1 Start Database amp Setup Select Database amp Setup in the NIOX Admin view This opens the Data base Management view displaying current setup and status For the Multi User setup go to section 5 6 5 Check connection to Network database NIOX Admin Database Setup Current Mode Local Database Single user SQL CE Backup Database Point out the location where to save the backup file No Backup taken Restore Database Point out the location of the backup file No Restore done Clear Database This will erase all data from the database Last Cleared 6Days ago 5 6 2 Clear a Single User database Clearing the database can be relevant if the system has been used for test purposes and to erase all test data permanently before clinical use It can also be useful after archiving backup of a database to start with a new empty database WARNING Clearing the database will erase all stored data permanently 1 Select Clear Database A popup warning appears 2 Complete the dialog This will erase all data from the database Note Itis possible to import a database from NIOX MINO Data Management Program version 2 1 0 1 or 2 2 0 0 when the da
13. ange by entering an interval Set the year month day by selecting Enter starting date in the top Vv row and ending date in the bottom row e Select to show or hide graph by sliding the button to show Graph ON or OFF e View a single measurement by selecting its row e Print or export the log by selecting Create report For details refer to section Create a report of a Journal on page 16 27 Chapter 6 NIOX QC 6 3 3 Add comments to QC measurements ie In the User Journal view select the measurement row to add a comment This will open the Measurement Details view NIOX QC Measurement Details RA Add Comment O Measurement id aaa 2014 w November vi 5 v eq no 159 14 v 12 v nstrument id 24263 MINO NO value ppb 13 Signature SystemAdministrator a Comment SAVE CANCEL Select the comments text field and enter the comment using the keyboard Adding a comment requires a signature when saving a login window will open Enter user name and password and select OK 28 Information in this document is subject to change Amendments will be made available by Aerocrine AB as they occur Copyright 2015 Aerocrine AB Solna Sweden Based on the company s intellectual property Aerocrine develops and commercializes products for the monitoring of nitric oxide NO as a marker of inflammation to improve the management and care of patients with inflammatory disease in the airways Pa
14. at the bottom of the screen by the up arrow button N Enter the patient details and select Go e To search enter a first name last name or a patient ID to find the relevant patient e The search results will be presented in a list e Leaving the search field empty and selecting go will show the patient records with the most recently performed FeNO measurements in a list e To hide the filter panel select the arrow down button M 11 Chapter 4 NIOX Patient Note Scroll using the vertical bar to view all information in the search result list 4 4 Open a patient Journal 1 Inthe search results list select a row to open the corresponding record The Journal for the selected patient is opened NIOX Patient Journal Sven Eric Aberg December 23 1948 es 4812232751 ee ee ok ed y O Pa CO Dr Tester Journal Notes Q 2014 04 03 The patient is suffering from season allergy TIMESTAMP NO ppb COMMENT SIGNATURE 2 2013 09 18 08 37 19 2013 09 12 16 55 22 Q 2013 09 12 11 20 22 2013 09 10 11 29 27 Import Manually Create Measurement from Measurement 2013 09 09 15 24 30 Database Q 2013 09 09 13 57 28 2013 September R 8 Measurement Mode 10 seconds 2 The Journal view displays an overview and several additional options for viewing patient data The fields tiles to the left e Patient ID displays the latest measurement result date and physician Selecting this
15. cluding ID with the keyboard e User name and Identity must be unique e User name first name last name and identity is mandatory to enter e Enter notes by selecting the Notes text box 6 NIOX QC The NIOX QC application enables the user to view QC users QC mea surements and instruments with measurements stored in the database It is also possible to create a report of a QC user or an instrument The QC measurement is performed on an instrument together with NIOX Panel and is thus described in detail in the relevant NIOX MINO NIOX VERO or NIOX Panel user manuals Note Note The external Quality Control QC is a procedure designed to ensure the instrument is operating within its specifications The NIOX QC application is used for managing QC users status of QC users and for managing the quality control of each connected instrument The Quality Control function in NIOX instruments must always be activated as a daily QC measurement is mandatory when the instrument is clinically used 24 Chapter 6 NIOX QC 6 1 Start NIOX QC 6 3 View instrument QC logs 1 Select NIOX QC This opens the Instrument amp Users view If a This feature enables printing of a list for the specific instrument and the Multi user network setup is selected the Instrument amp Users view will measurements performed The list is primarily intended for review purpos display all instruments that have QC measurements stored in the
16. eden www aerocrine com WWW NIOx com 1 5 Warnings e NIOX Patient should only be operated by healthcare professionals e Operate NIOX Patient as stated in this manual Aerocrine accepts no responsibility for damaged application or faulty results if the application is not handled according to this manual e Modification of NIOX Patient application is not allowed e Do not use a damaged application e All warnings in the NIOX MINO User Manual are also applicable when NIOX MINO is used together with NIOX Patient Chapter 2 Product description e All warnings in the NIOX VERO User Manual are also applicable when NIOX VERO is used together with NIOX Patient 1 6 Intended use NIOX Patient is a PC application designed to store display and report a patient s FeENO measurements obtained from any NIOX instrument As NIOX Patient is preferably used in conjunction with NIOX Panel and NIOX instruments it is recommended to read their corresponding user manuals in conjunction with the use of NIOX Patient NIOX Patient can store data either locally or in a network database 2 Product description 2 1 NIOX Patient NIOX Patient is designed to manage patient records measurements re ports and database administration The software contains an administra tive mode to manage user information customize patient records and reports The database allows measurements pertaining to a specific patient to be centr
17. es 2014 04 03 The patient is suffering from season 2 allergy TIMESTAMP NO ppb COMMENT SIGNATURE 2013 09 18 08 37 19 2013 09 12 16 55 22 C 6 2013 09 12 11 20 22 2013 09 10 11 29 27 Import Manually Create Measurement from Measurement 2013 09 09 15 24 30 Dabas 2013 09 09 13 57 28 GRAPH On il Measurement Mode ge Fae v 18 Limits Off W 10 seconds valid for printout Create Report 0008 18 02 NIOX Patient User Manual US Chapter 4 NIOX Patient Note A measurement in the graph marked with red is performed with an instrument with Daily QC not approved 4 To show the limits slide the Limits slide button to the right The text beside the button will display Limits ON To display the view without showing the limits slide the Limits slide button to the left The text beside the button will display Limits OFF Note To change limits just drag the numbers on the left side of the graph to the correct value 5 To printa report select Create Report See details in the section Create a report of a Journal on page 16 4 5 Make changes to an opened patient record When a patient Journal is opened it is possible to edit patient details enter a new Journal note delete Journal notes manually add measurements or import from an earlier connected instrument If several instruments have been connected to the database measurements can be imported from any of the instrume
18. ft corner 0008 18 02 NIOX Patient User Manual US Chapter 5 NIOX Admin 5 3 Create new user 1 Select Create New user This opens the New User view NIOX Admin User Details User Account User name r must be unique Role Privileges NIOX QC B NIOX Admin NIOX Patient User Details First Name f Last Name _ Identity e g employee no must be unique User Status Active or Inactive t in Dalahase Active KAE SAVE CANCEL 2 Select the relevant text boxes and enter the user account information and user details including ID with the keyboard e User name and Identity must be unique e User name password first name last name and identity is mandatory to enter e Enter notes by selecting the Notes text box Note Remember to note the user name and password to give to the new user 3 Check the relevant privileges check box es to give the user access to NIOX Admin NIOX Patient and or NIOX QC applications Note To inactivate a user in the database slide the User status button to show Inactive 4 Select Save to save the changes and return to the NIOX Admin Users amp 0008 18 02 NIOX Patient User Manual US Settings view Cancel leaves the view without saving changes 5 3 1 Search user 1 Select the search text field at the bottom of the screen enter the user details and select Go e Type a name or user name or an ID in the search field e Search among inactive users
19. ke cer tain that you fully understand the safety information NIOX MINO User Manual or NIOX VERO User Manual respectively ap plies for how to use the different devices Symbol Description WARNING Indicates a potentially hazardous situation that if not avoided can result in bodily harm or injury CAUTION Indicates a potentially hazardous situation that if not avoided can damage a product or system cause loss of data or harm to business Note Alerts the reader to important information on the proper use of the product user expectations error situations and actions related to these 1 2 About this manual NIOX Patient User Manual English US 000818 EPM 000225 version 02 May 2015 Information in this document is subject to change Amendments will be made by Aerocrine as they occur Aerocrine NIOX NIOX MINO and NIOX VERO are registered trademarks of Aerocrine AB 0008 18 02 NIOX Patient User Manual US The User Manual provides instructions on how to operate NIOX Patient It contains numbered step by step instructions with screens and illustrations Buttons are illustrated in bold or as icons Choices within steps are dis played with bullet points 1 3 Compliance NIOX Patient is CE marked according to In Vitro Diagnostics Directive 98 79 EC 1 4 Responsible manufacturer and contacts Aerocrine AB Rasundavagen 18 169 67 Solna Sweden Aerocrine AB P O Box 1024 SE 171 21 Solna Sw
20. lled in a per user folder and be available just for your user account You do not need local Administrator privileges Install for all users of this machine NIOX Apps will be installed in a per machine folder by default and be available for all users You can change the default installation folder You must have local Administrator privileges This feature requires 14MB on your hard drive Pep NIOX Apps Setup Destination Folder Click Next to install to the default folder or dick Change to choose another Install NIOX Apps to Please wait while the Setup Wizard installs NIOX Apps C Program Files x86 Aerocrine 8 The programs are now available in the selected location or in the start menu 000818 02 NIOX Patient User Manual US Chapter 3 Installation and setup 3 3 Database setup NIOX Patient is connected to a SQL CE database by default NIOX Database Setup NIOX Database Setup Use SQL CE 4 0 local database Use SQL CE 4 0 local database Use Sql server Use Sql server 3 3 1 SQL CE Single user database setup 1 Start the Database Db program from the start menu 2 Select SQL CE local database 3 Select Test connection 4 Select Save connection 5 NIOX Patient is now connected to the local database installed on the computer 3 3 2 Note SQL Multiuser Database setup Before NIOX Patient can be connected to a multiuser Database the database ha
21. n Qualifying ooo 0e 1717 Daily QC Not Passed 14 QC Usen o ving o o a oe o OC Disabled n OcU Ouayg o Daily QC Passed 8 OC User Database Qualified 62 O aaa Day OC Passed 6 OC User Database Qualified e 6 3 2 View QC Users details In the QC Users view it is possible to see all QC users and what status they have NIOX QC Select users or instrument log QC Users Data amp Details 030800412 030800398 Versor 10 4629 dbver 1 Y v 031100714 24263 1 Select QC Users Data amp Details This opens the QC Users view 26 Chapter 6 NIOX QC 2 Search for a user by entering a user name in the search field at the 3 Select a user in the list This opens the QC User Journal view bottom of the screen and select Go NIOX QC User Journal NIOX QC Users Yki Seb Tom Type in search field to filter users QC User Stage ihe SE Comment System Administrator C000 Cr Qualifying Anna Meier 0o Qualifying Johnny Jones eeo Qualifying Jimmy jones eeo 14 12 12 2014 EEM ae Snaps TIMESTAMP oi mi Re COMMENT SIGNATURE 11 19 2014 11 49 AM 17 5 lt QCD lt 24 24263 11 13 2014 12 00PM 11 031100714 11 11 2014 10 12 AM 16 030800398 11 10 2014 3 31PM 14 030800398 GRAPH On i i Create Report 4 Inthe QC User Journal view it is possible to review the specific QC users measurements and select among the following options e To narrow the log list r
22. nt Journal view Cancel leaves the view without saving changes 1 To delete a Journal note select the row with the relevant Journal note The Edit Journal Notes view opens Slide the button Deleted to display Yes Select Save to save the changes and return to the Open Patient Journal view 14 0008 18 02 NIOX Patient User Manual US Chapter 4 NIOX Patient 4 7 Manage measurements 4 7 1 Manually add measurement to a Journal 1 To add a measurement to an open patient Journal select Manually Create Measurement The Measurement Details view opens NIOX Patient Measurement Details RA New Measurement 2013 v September vi j11 v 15 v 36 vi SAVE CANCEL 2 Select the relevant text box es and enter changes with the keyboard or select the arrow down button and then mark a value in the appearing drop down list Note Mandatory information must be entered FeNO value 3 Select Save to save the changes and return to the Open Patient Journal view Cancel leaves the view without saving changes 0008 18 02 NIOX Patient User Manual US 4 7 2 Add comments to a measurement To add comments to a measurement select the measurement in the list add the comment and click Save The signature of the current user will be added automatically 4 7 3 Import measurements to a Journal 1 To import measurements to an open patient Journal select Import Measurement from Database The Import Measurements view opens ill
23. nts in the network 0008 18 02 NIOX Patient User Manual US 4 5 1 Edit patient details 1 To edit patient details select the button displaying the patient ID This opens the Edit Patient Details view NIOX Patient Patient Details Patient Physician Information Dr Tester v Aberg 1948 12 23 4812232751 mf ate Measurement Upper Limit 25 SAVE CANCEL 2 Select the relevant text box es and enter changes with the keyboard E 3 Select Save to save the changes and return to the open patient Journal view Cancel leaves the view without saving changes e To change physician select and choose a physician from the appearing drop down list Note To add a physician use NIOX Admin new physician 13 Chapter 4 NIOX Patient 4 6 Patient Notes 4 6 2 View Journal note 1 Select Journal Notes in the patient Journal view This opens the Journal 4 6 1 Enter Journal note Notes view 1 To enter a new Journal note select Create Journal Notes The Journal Notes view opens NIOX Patient Journal Notes D Sven Eric berg ID 4812232751 TIMESTAMP g o Date amp Tim Soe N IOX P ati e ane J O u AA a N ote 2014 04 03 11 55 The patient is suffering from season allergy Anna Anna Add The patient is suffering from season allergy Journal Note 4 6 3 Delete a Journal note 2 Enter the new Journal note in the text field Select Save to save the changes and return to the open patie
24. onal and a new password recommended Refer to Edit user on page 19 5 Print and save the new administrator credentials in a secure place Note Make sure that the password is saved in a secure way 3 6 Installation of NIOX Database on SQL server Before NIOX Patient can be connected to a multiuser Database the data base has to be created The database should be created by a network ad ministrator 1 Start Microsoft SQL Server Management Studio log on to the SQL server 2 Select Create new Database Name the database i e NIOX 4 Open New Query in Management Studio Copy the T sql script available on the USB stick in the SqlServerScript folder to the query window Change use database name to use NIOX 5 Run the T sql script This creates all necessary tables to store NIOX information and also initializes the user table with the built in administrator account 6 Connect to the database with NIOX Database and then start NIOX Admin to change the user name and password for the built in administrator account 0008 18 02 NIOX Patient User Manual US 4 NIOX Patient NIOX Patient is used to administrate information regarding a specific pa tient create new patient records search for specific patient records view records add or delete notes manually add measurements or import mea surements from an instrument It is also possible to print the records in various formats NIOX Panel is used
25. ou want to do NIOX Users Database amp Setup Manage Users amp Credentials Link amp Backup Physician Report amp Setup Add amp Inactivate Physicians Setup amp Configure If the multiuser network database setup is implemented the system can ac cess data from all connected instruments 17 Chapter 5 NIOX Admin One or several users may be appointed administrators of the system Ad 1 ministrators can add and delete NIOX users and set privileges and status 51 Start NIOX Admin 1 Select NIOX Admin This opens the NIOX Admin view where further choices can be made 2 Toreturn to the NIOX Admin view from any other view select the arrow icon next to the view title in the top left hand corner of the screen 3 To close NIOX Admin select the X in the top right corner 5 2 NIOX Users NIOX Users allows administrators to add or inactivate users and set rele vant privileges to the users 18 Select NIOX Users This opens the NIOX Admin login view NIOX Admin Enter your credentials Username Password oc Enter User name and password This opens the Users amp Settings view displaying users and applications access e Applications marked with a check mark are accessible e Applications without a mark are not accessible V Select which category of users to display by setting the slide button Show users that are to show Active or Inactive in the bottom le
26. rt by selecting Upload Replace button 2 Select a report to be uploaded 3 Slide the button next to the uploaded report to ON 4 Click Save and the uploaded report is available in NIOX Patient for print 21 Chapter 5 NIOX Admin 5 5 Physicians The option Physicians available in NIOX Admin is used to create user profiles for the professionals working with the NIOX instruments Entering the physician is useful for a doctor when searching for a patient 5 5 1 Add physicians 1 Select Physicians in the NIOX Admin view This opens the Physicians view 2 Select New Physician This opens the New Physicians view NIOX Admin Physician Details 3 Enter the physicians name Note Physicians name must be unique 4 Set the Physician status by sliding the button to show Active or Inactive 5 Select Save to save the changes and return to the Physicians view Cancel leaves the view without saving changes 5 5 2 Edit physicians entry 1 Select the physician in the appearing list This opens the Edit Physicians view NIOX Admin Physician Details e Select the text box and edit the physicians name e Change the Physician status by sliding the button to show Active or Inactive 2 Select Save to save the changes and return to the Physicians view Cancel leaves the view without saving changes 5 6 Database amp Setup The option Database Setup available in the NIOX Admin view is used to manage backup
27. s to be created For instructions Installation of NIOX Database on SQL server on page 9 1 Start the Database Db program from the start menu 2 Select Use SQL Server 3 Enter the address of the SQL Server computer name database instance name 0008 18 02 NIOX Patient User Manual US 4 Enter the name of the database Select Authentication Method Windows Authentication continue with step 7 or SQL Server Authentication 6 Enter SQL Server user name and password Note Print and save the credentials in a secure place 7 Select Test connection 8 If the test is successful select Save connection 3 4 Server requirements Server requirements e Microsoft SQL Sever 2008r2 3 4 1 Server installation and configuration 3 4 2 Network requirements To be able to connect to the multiuser database a network connection be tween the computer and the network database is needed Contact your net work administrator 3 4 3 Import database from DataManagement Program It is possible to import a database from NIOX MINO DataManagement Pro gram version 2 1 0 1 or 2 2 0 0 to an empty single user database For in structions on how to create a backup from Data Management Program refer to the Data Management Program User Manual Chapter 3 Installation and setup Start Admin select Database amp Setup If the database is empty select Re store DM Database Select the backup file to import the database
28. se Agreement Click Install to install the product with default options for all users Click Advanced to To create a standard installation select install and continue with step Ve To change installation path or add more features than predefined select advanced F if NIOX Apps Setup x4 Please read the NIOX Apps License Agreement License Agreement NIOX Apps Software a This is a License Agreement Agreement between you the Licensee and Aerocrine AB the Licensor regarding the NIOX Apps Software the Software and any upgrades thereof ATTENTION PLEASE READ THIS DOCUMENT CAREFULLY BEFORE CLICKING ON THE I ACCEPT BUTTON IN THE INSTALLATION PROGRAM BY PRESSING I ACCEPT THE LICENSEE ACKNOWLEDGES TO HAVE READ THIS AGREEMENT AND AGREES TO BE BOUND BY ITS TERMS AND CONDITIONS IF THE LICENSEE DOES NOT AGREE TO THE TERMS OF THIS AGREEMENT THE X V I accept the terms in the License Agreement Click Install to install the product with default options for all users Click Advanced to change installation options Print Advanced Install Cancel Chapter 3 Installation and setup 6 Select what features to be installed and then click install 1 4 aa Product Features Select the way you want features to be installed Choose the installation scope and folder Install just for you thbj NIOX Apps will be insta
29. t refer to BuiltinReportVariables docx BuiltinReportVariables docx contains all possible variables to use in a customized report 4 9 Automatic import of measurements from NIOX Panel NIOX Panel is an optional visual aid and software allowing the user to op erate the NIOX instrument from a PC Provided that the patient ID is entered a patient measurement performed using NIOX Panel will automatically be saved to the correct patient in the NIOX database Note Note A measurement performed with NIOX Panel without entering the patient ID is stored in the NIOX database and must be matched manually to the correct patient in the database If a patient Journal is already opened the patient will be selected in NIOX Panel patient ID search field 0008 18 02 NIOX Patient User Manual US 5 NIOX Admin The application NIOX Admin is used to manage user information and user privileges It contains several options NIOX Users is used to manage users edit user information add new users and manage account credentials Physician is used to add or edit physicians QC Users is used to add or edit QC Users Database amp Setup is used to perform backup restore or clear the database for standalone usage Report amp Setup is used to customize the information shown in Journals and reports NIOX Users allows administrators to add or inactivate users and set relevant privileges to the users NIOX Admin What do y
30. tabase is empty 5 6 3 Perform a backup of a Single User database 1 Select Backup Database This opens a popup dialog 2 Select a folder where to store the backup file 3 Select Save This creates a backup file of the database 5 6 4 Restore database to previous version If the data stored in the database has been corrupted in any way choose to restore the database from a previously saved backup file 1 Select Restore Database This opens a popup dialog 2 Select the backup file 3 Select Open This restores the database to the selected version 5 6 5 Check connection to Network database 1 Select Check connection with Database This verifies the network connection e A fully functioning connection is reported with Connection successful e A malfunctioning connection is reported with Connection not successful Contact the system administrator to address the problem 23 Chapter 6 NIOX QC 5 7 QC Users QC Users allows to add or inactivate QC users and view all QC Users 5 7 1 Create new QC User 1 Start NIOX Admin 2 Select QC Users This opens the QC Users view 3 Select Create New The new users view opens NIOX Admin User Details User Account Role Privileges ser name NIOX QC must be unique User Details First Name Last Name Identity e g employee no must be unique CANCEL 4 Select the relevant text boxes and enter the QC user account information and user details in
31. tents For information about patents relating to Aerocrine products see www aerocrine com Aerocrine An ISO 13485 certified company Aerocrine Inc 5151 McCrimmon Parkway Morrisville Suite 260 NC 27560 USA Phone 1 866 275 6469 Fax 1 866 329 6469 E mail service us aerocrine com www aerocrine com Copyright 2015 Aerocrine AB Solna Sweden Aerocrine NIOX NIOX MINO and NIOX VERO are registered trademarks of Aerocrine AB
32. to automatically store measurements in the database or directly into a patient record Note To avoid having to import measurements from instruments Aerocrine recommends selecting the patient in NIOX Panel before performing a new measurement If the patient does not exist use NIOX Patient to create the patient 4 1 Start NIOX Patient 1 Select NIOX Patient This opens the login view NIOX Patient Enter your credentials Username Password Chapter 4 NIOX Patient 2 Enter user name in the User name text field 3 Enter password and select OK This opens the NIOX Patient view Canne NIOX Patient Session Management SystemAdministrator a what would you like to do NIOX Patient P Type in search field for patient journals Change Switch Password User A Patient Logoff close program DATE OF Co z BIRTH Create New 5 In the Session Management there are three options e Select Change password to change password 4 The name of the current user will be displayed in the top right hand e Select Switch user to log in as a different user corner Select the name and the Session Management view will open e Select Log off to close NIOX Patient 10 0008 18 02 NIOX Patient User Manual US Chapter 4 NIOX Patient 4 2 Create new patient 1 In the NIOX Patient view select Create new patient The Patient Details view opens NIOX Patient Patient Details
33. ustrating which instruments are connected to the database via NIOX Panel 2 Select which instrument to import measurements from This opens the Select Measurements to Import view Note The measurements displayed are performed on an instrument when connected to NIOX Panel and not matched to a patient ID For more details see page 17 Note If only one instrument has been connected to the database step 2 is not available Proceed to step 3 Note The search field is automatically populated with the opened patient journal ID 15 Chapter 4 NIOX Patient 4 8 Create a report of a Journal In the opened patient Journal view there are several print options NIOX Patient Import Measurements Note The report will contain the content shown on the screen Select whether to include or exclude graphs limits and time intervals SEQNUMBER TIMESTAMP ID from INSTR NO ppb Mode 2013 09 02 125 Tense according to the descriptions on page 12 2013 09 02 125 TenSe oes bina Note If Microsoft Word is not installed there is an installation file for 2013 08 29 125 TenSe 2013 08 29 125 Tense Word viewer available on the USB stick Just click on the setup file a la and follow the instructions on the screen 2013 08 23 12 TenSe 2013 08 22 0123456789 TenSe 2013 08 22 0123456789 Tensecon 1 Select Create Report A view with print options will open 2013 03 06 1234 SixSecond Quick Print 2012 02 03 12345 TenSecon Select
34. wn in the word doc as unique identifiers Built in reports are installed during the installation and saved in the folder c programfiles x86 aerocrine NIOX Apps built in reports Note Patient report can be selected from NIOX Patient Journal view To customize the appearance of a report 1 Open the built in reports folder c programfiles x86 aerocrine NIOX Apps built in reports 2 Select one report edit the report by placing the unique identifiers at preferred look save Note Make sure to not change the unique identifiers because then the information will not be recognized and not shown in the report For a complete customization of a report open the Reporting Variables file to identify all possible information to be shown in the report Patient name Patient identification Patient date of birth Patient gender Patients current physician Upper limit when not set Lower limit when not set Latest FeNO value for the patient Date and time for latest FeNO value Date only for latest FeNO value Latest ambient NO value Date and time for latest ambient NO value Date only for latest ambient value Latest nate text for the selected patient Date and time for latest note Date only for latest note Instrument identification when applicable for example QC reports Note If Microsoft Word is not installed Word viewer is available on the USB stick 5 4 3 Upload a customized report 1 Upload the customized repo
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