x-screen - R-Biopharm AG
Contents
1. Reader ID Signature 24 RIDA SCREEN 1000000 16 CONTROL SAMPLE QUALITY CONTROL Control sample The control sample is provided by the manufacturer for examination of the performance features of the RIDA X Screen By using the control sample troubles during the measurement of pa tient samples might be detected and or quality control can be car ried out The control sample is a membrane with 9 positive bands and 11 negative bands The positive bands are evenly spread on the mem brane surface to make sure that the camera is working properly over the complete membrane The results which the positive and the negative lines must achieve is stored in the rdf file If the control panel and the RIDA X Screen is working properly tvery line will be attributed with a green passed lf one or more lines achieve wrong values then either the panel is deteriorated or the camera is not working properly In order to find out the reason for the failed quality check of your system you should order another control panel If the measurement is fine with the new one the old panel was deteriorated or in case the problem still exists then the camera must be checked from the manufacturer Please contact your local distributor Caution In case there has not been conducted a documented continu ous examination by using the control sample the manufacturer excludes every warranty for the measurement values Fre2. Even Examination Y Load Patient EZ rroryep01 Beso Repon e Print K Exit Name PUBLIC JOHN Q DOB 01 01 2001 1D la Patient Sample AS P2 28 02 2011 17 51 27 AS P2 28 02 2011 17 50 40 Y Allerg Class Allerg IU ml I z 2 65 2 6 M1 0 00 0 0 D2 3 57 3 0 M2 5 45 3 1 T2 13 24 3 6 M3 0 00 0 0 T3 11 90 3 6 M6 6 71 3 2 TA 10 82 3 5 T7 17 37 3 9 Gx gt 100 6 0 G12 gt 100 6 0 15 06 3 8 5 60 3 1 E1 2 12 25 E3 2 97 2 8 E5 0 26 0 7 E6 0 43 12 E84 0 00 0 0 E82 0 00 0 0 Control gt 100 6 0 Test valid Commen t RIDA 5creen x 4fe ie dale af AE patent ie De mrevocailiy deleted FOL ARE BORE F RIDA X Screen 20 RIDA SCREEN 1000000 13 IMPORT EXPORT OF EXAMINATIONS DATA TRANSFER SAVING DATA Data transfer of single measure e You can import and export the examination data of any pa ments tient to and from any destination on the local drive or on your network e So you can exchange the results of the measurements be tween different RIDA X Screen Reader systems tient E mpon Expon PR roy Re Data transfer In the program ASCII Reader PDF MENU BAR esl Un 17 50 40 E 50740 Import Export 7 x Export Information i Export ASCII CARAPIDIPICTUREPUBLIC Probe Test Panel 2 v50 UK DATE 28 02 201 1 TIME 17 51 27 ASC created Select either ASCII or Reader When having selected ASCII export is generated automatically
3. fore having installed the software completely If you have any questions concerning handling of soft or hardware please contact R Biopharm AG or your distributor by phone fax or email Telephone 49 0 61 51 81 02 0 Telefax 49 0 61 51 81 02 40 e mail info r biopharm de Order orders r biopharm de Address R Biopharm AG An der neuen BergstraBe 17 64297 Darmstadt Germany This manual has been edited conscientiously and complies with the Norm DIN EN 591 Manual Version 0401 RR 0009 10 2011 04 28 Valid for RIDA X Screen with the last 4 figures of the serial number of 5496 or higher R Biopharm AG RIDA SCREEN 1000000 3 TECHNICAL SPECIFICATIONS STORAGE SETTINGS This system can be applied according to the conditions of EN 61326 1997 A 1 1998 Class B for emission and absorption Dimensions 262 x 110 x 200 mms H x W x L Weight 0 9 kg Physical data 5 V 0 5 Ampere Consumption maximally 2 5 Watt Storage and operating Storage temperature should not be under 0 degree and not over 50 temperature degrees Celsius Location or rather operating temperature of the instrument should not be under 10 degrees and not over 40 degrees Celsius Basic settings The factory made basic settings are conducted by the set up routine and can be verified in the manual chapter control sample quality control Measures of installation The instrument should not be exposed to direct and permanent ra diation o
4. Extra Window Help Add Test E Change Change Display Resolution _ Change Address Language ame User Date of birth Advanced Lamera b Test Cutoff Mode Measurement Paths Probe ID Survey Already established user profiles will be shown with name and status active YES NO see below User status e Active status YES The user is able to start the program o Active status NO The user is not able to start the program User Account l Administrator 2100 O 9 R Biopharm AG RIDA SCREEN 000000 5 USER ADMINISTRATION USER PROFILE ICONS Icons The options of the user administration are accessible by using the follow ing 4 icons kh Add User Account Adding a new user profile Close User Account Modify User Account Changing the functions of an user profile Leaving the user administration Add User x User Username Password Password Pl confirm Active v Administrator Add test Change patient data Comments Delete examination Delete patient Examination export Examination import Examination validation Measurement Printout Sample ID modify Service modul Open measurement patient data X Cancel Y Add AAA AAA A ASA A R R Biopharm AG Delete User Account Deleting an user profile if Add User or Modify User is activated a window for changing the user profile appears 10
5. R Biopharm AG RIDA X Screen User Administration File Extra Window Help new Examination qi Load Patient Le mporvexpor E Print x Exit Name Date of birth ID AllergyScreen Panel 3 v1 done W CAL 05 v1 UK AllergyS creen Panel 2H v1 UE AllergyS creen Panel 1 0 v1 UE AllerguS creen Panel 2 0 v1 UK AllerguS creen Panel 3KO v1 UK AllergyS creen Panel 4E0 v1 UK Allergy5creen Panel ME v1 E AllergyScreen Panel 3ME v1 E AllergyS creen Panel MENA v1 UE AllergyScreen Panel SMENA v1 UE AllergyScreen Panel 1PE v1 E AllerqyScreen Panel 1 v1 D AllergyScreen Panel 1 v1 TR AllergyScreen Panel 1 v1 UE AllergyScreen Panel 2 v1 O AllergyScreen Panel 2 v1 TR AllergyScreen Panel 2 v1 Uk AllergyScreen Panel 3 v1 D Allergus creen Panel 3 v1 TR AllergyS creen Panel 3 v1 UK Allergy Screen Panel 4 w1 D Allergy creen Panel 4 v1 TR AllergyS creen Panel 4 v1 UE Allergy5 creen Panel 1T v1 UE allerguS creen Panel 2TA v1 TR AllergyS creen Panel 27TA v1 UK AllerguS creen Panel 3TA v1 TR AllerguS creen Panel 3TA v1 UK Allergy5 creen Panel 2H v4 UK AllergyS creen Panel 1KO v4 UK Allergu5 creen Panel 2 0 v4 UK AllergyS creen Panel SEO v4 UE AllergyS creen Panel 460 v4 UE AllergyScreen Panel 2ME v4 E Info e Testinstalled Test removed 14 RIDA SCREEN PYYYYY TT 8 ADDING A NEW PATIENT OPENING CHANGING PATIENT S DATA Explorer x Set Hew Examination Name Firstname Da
6. 0 00 ac2i 28 02 2011 10 55 33 pel ace 28 02 2011 10 36 23 1 ee F13 gt 100 6 0 Control gt 100 6 0 Test valid Commen t R Biopharm AG 18 RIDA SCREEN vee 10 MEASUREMENT AND EVALUATION MEASUREMENT DATA CURRENT OR PRIOR MEASUREMENTS Measurement data RIDA X Screen Rel 615f User Administrator Panel 1 a Extra Window Help kE E A A A E New Examination y Load Patient 2 Import Export g Name QC 5496 5525 DOB 28 02 2011 ID Prior measurement O Examinations which were saved or archived can be re AS P1 v13 28 02 2011 17 35 57 called by clicking the entry in ac 21 28 02 2011 17 35 09 the exam list QC 21 28 02 201 11 41 19 QC 21 2802201 11 41 06 e 0c 21 28 02 2011 11 40 57 gt clicking on exam list Qc 21 28 02201 11 36 32 QC 21 28 02 2011 11 36 23 QC 21 28 02 2011 11 36 11 QC 21 2802 2011 11 31 32 QC 21 28 02 2011 11 31 15 11 DELETING A PATIENT DELETING PATIENT S DATA Deleting a patient Explorer OOOO O Name Firstname Date of birth 79 72 2777 In the program ALL ae co EF GH U KL MN oP 08 st Juv sv 10 03 1554 MENU BAR y NEW EXAMINATION O Select the patient who is going to be deleted Delete Use Delete Add Street State City Country ZIF ID Confirmation RIDA X Screen xj J E T A r pe e The selected patient s data Are ite dela af ihe patent ie De irevocabile deleted will be deleted ir
7. Panel 2 v50 UK DATE 28 02 201 1 TIME 17 51 2 a AddOn 5 005496 5525 021110005516 0C 21 2011 02 28 11 36 32 351 PDF H f Backup 005496 5525 021110005522 00 21 2011 02 28 11 40 57 352 PDF E CAL DATA 12 005496 5525 021110005522 00 21 2011 02 28 11 41 06 353 PDF E E DATA 0C5496 5525 021110005522 QC 21 201 1 02 28 11 41 19 354 PDF DATABASE 0C5496 5525 091010005399 QC 21 201 1 02 28 17 35 09 355 PDF 005496 5525 AS P1 v13 2011 02 28 17 35 57 356 PDF E DATABASE 10 leer test PDF j 22 RIDA SCREEN 10000000 14 PRINTOUT OF RESULTS PREVIEW PRINTOUT Preview printout You can activate the preview and printout by using the icon Print in the respective window Preview and printout of the current result pot Pint gt E ient Sample In the program PRINT Actual gox f Screen EM Full Page Pin gt Yee The result is shown in the preview window Assay Report AllergyScreen Panel 2 v4 D Screen performed by erformed for In order to print the preview click eee on the button print in this preview 01 01 2001 window 10 09 2007 an The report is printed out on the default printer of Windows D1 mI lma f Tl D2 7 MEN we Meg ES ez in Aa Allergen Allergen Me Class Valuation Code Name D1 Derm pteronyssinus 3 42 2 9 erh ht D2 Derm farinae 8 27 3 3 deutlich erh ht T2 Erle 11 33 335 deutlich erh ht T3 Birke 13 60 37 deutlich erh ht Print ou
8. the R BIOPHARM AG copyright mark on the disk and include it Neither the notice of copyright nor the registration number shall be removed It is explicitly forbidden to copy the software and written material neither entirely nor partially in its original or altered format in a mixed version with another software or in a version combined with another software Transfer of right of use The right of use of the software may only be transferred to a third party with the prior written approval by R BIOPHARM AG and only under the conditions of the terms of this contract Giving away for free leasing renting out or lending are explicitly forbidden Duration of contract The contract shall last for an unspecified period of time The licensee s right to use the software automatically expires without notice if he breaks one of the conditions mentioned in this contract The licensee shall destroy the original CD as well as all copies of the software includ ing software versions which have been altered plus all documents upon termination of the right of use Compensation for damages due to break of contract R BIOPHARM AG will make you liable for all damages resulting from copyright infringements which arise from breaking any condition of this contract Alterations and updates R BIOPHARM AG is allowed to create updates at its own discretion R BIOPHARM AG is not obliged to provide such updates to licensees who did not pay the update fee Warranty and liabi
9. 0 Bb O 11 12 13 15 16 17 18 19 19 20 21 22 24 26 2 28 29 RIDA SCREEN 1000000 1 GENERAL Purpose Performance features Output of analytical data Scope of use Application not recommended by the manufacturer Safety instructions and cautions Action in case of emergency The RIDA X Screen is an instrument that evaluates the reflection or optical density of a biochemical reaction compared to the environ mental background of the measured sample The RIDA X Screen can detect optical density signals of 0 25 or greater When there is an optical density of 5 reproducibility of 0 2 optical density can be achieved The performance of the RIDA X Screen is heavily dependent on the computer used however it is possible to read a test every 30 seconds In order to achieve this optimum performance level it is recommended to use the computer specified Measurement values of the RIDA X Screen are correlated linearly to the reflected density measurements of the control function Optical densities are divided into several segments The figure shows a high signal generated by the RIDA X Screen The measurement of the reflected density allows the interpretation of a negative test result negative result RIDA X Screen Signal 1 positive result reflected density 1 During the set up routine different tests released by the manufacturer are transferred on the
10. Confirm by clicking on OK The ASCIl file will be stored under CARAPID Export When having selected READER or PDF ae E e Choose directory e Enter file name O Save file The file is stored in the selected Filename directory as a BCD or PDF file File typ Rapid Reader FILE BED H Cancel T Mit Schreibschutz offnen Saving data Information SS IMPORTANT i Exporttile CARAPIDAE PERTAR Biophara TEST BCO created O lt is recommended to run back ups of the acquired data on an external storage system on a regular basis e The BCD file might be sent to all RIDA X Screen users Data can be shown at the receiver s places by clicking on import 21 R Biopharm AG RIDA SCREEN Export of several measurements Select all measurements you want to export and click in the list with the right mouse button click on Selected and the on PDF Now all measurements will be stored under C Rapid Export The file name consists of the pa tient s name the panel date time running number paf If you have selected Clipboard you can enter the measurement data in text editor programs or spread sheets R Biopharm AG e You can printout or export as PDF or store in the clipboard the data of multiple measurements 3 Selected Print ER w13 25 06 2008 33 13 25 06 2008 Blipboard E a 5 PAPD a gt EINGANG Probe Test Panel 2 v13 UK DATE 23 07 2009 TIME 10 5E a PUBLIC Probe Test
11. Line Value QC C 4 2 passei 16 6 0 passed 1 2 4 passed 1 0 0 passed 2 0 0 passed 18 0 0 passed 3 0 0 passed 19 25 passed 4 0 0 passed 20 42 passed 5 0 0 passed 6 6 0 passed Ref QC line Target Range 7 0 0 passed 2 5 7 9 11 13 15 17 18 00 lt 1 0 8 3 1 passed 1 10 1419 25 2 1 2 9 9 0 0 passed i 31 a a A 10 2 5 passed C 20 4 2 3 8 4 6 11 0 0 passed 6 16 6 0 gt 5 8 12 0 0 passed 13 0 0 passed 14 2 8 passed FAR i 15 0 0 passed QC Reader 021110005523 passed Comment Note Handling e The control sample should be stored at room temperature control sample under dark and dry conditions in the original package e Record the date opened on the package o However after the first measurement the control sample should not be used longer than 6 months e You can obtain new control samples from your distributor R Biopharm AG Telephone 49 0 6151 8102 0 R Biopharm AG 26 RIDA SCREEN 1000000 16 CONTROL SAMPLE QUALITY CONTROL RECORD A A e Further proceeding when test signature generated failed PEO IESO Id Eno IO PO IESO Id Eno IO PO IESO tad id IS PO IESO ese associated TA aae AA aana Bic sn A cia cn AAA a A eens A AA ene AA AA aaa AAA AAA ce ts AAA COI Mii aas A ci cc AA ss CCC AA a A sr A e AA N R Biopharm AG RIDA SCREEN 1000000 17 TROUBLE SHOOTING MAINTENANCE Target and source equal You tried to import a file that The file is already on the PC w
12. REEN 2000000 4 SYSTEM REQUIREMENTS SYSTEM CHECK System check The installation program tests all essential points of the installed compo nents in the computer The RIDA X Screen has special system require ments Test function Error handling Operating System Windows XP Windows 3 1 95 98 98SE ME 2000 are Windows Vista detected Windows 7 The computer is not adapted for the installa tion of the software Error correction Installation of an appro priate operating system any existing data should be stored on external media Graphic resolution Graphic depth Current Colors Hard drive free Printer default Printer installed Windows XP Windows Vista Windows 7 See Operating System requirements Minimum 1024 x 768 Pixel Resolution 1024x768 Pixel not found The graphic card is not sufficient for this program The resolution is not adequate Error correction Change the current graphic card and use a card with a resolution of minimum 1024 x 768 with a color depth of 16 bits or more 16 bit or more The current settings do not correspond to the required values but will be sup ported by the graphic card Refer to the manual Monitor Resolution Minimum 10 GB The hard disk space free is less than 850 MB Delete files that are not required from the hard drive or increase the size of the hard drive Data should be stored on external media Printer ins
13. RIDA SCREEN 1000000 9 USER ADMINISTRATION USER PROFILE OPTIONS OPTIONS DESCRIPTIONS User Name of the user Allowed signs A Z a z 0 9 Password Type in password Allowed signs A Z a z 0 9 Password confirm Type in password Allowed signs A Z a z 0 9 v the user is able to start the program Administrator Only the program administrator can use all program functions inclusive the user administration The user profile ADMINISTRATOR can not be deleted Add test Adds a new test In the program EXTRA ADD TEST Change patient s data Changes the patient s data or other data base informa tion Adds comments to the single measurements Delete examination patient Deletes single measurements and or patient s data Examination import export Can import or export single measurements Examination validation Can validate single measurements Measurement Can perform examination measurement of patient sam ples Prints out the measurement results Sample ID modify Changes the sample ID numbers Can change the internal program settings Open measurement Archived data can be opened and regarded from the data bank patient s data 11 R Biopharm AG RIDA SCREEN 2000000 6 MENU BAR PROGRAM OPTIONS SUB MENU DESCRIPTION New examination Creates a new examination for an existing patient Load patient Loads a patient and its existing examinations Import Export Allows data transfer be
14. UNISTRASSE 4 State BERLIN Cancel City BERLIN Country DEUTSCHLAND C ick O n Accept to zip 10789 ID 15656 145640 Accept continue Select Test x 004004 Sllerguscreen Panel 1 v4 D 004004 AllergyScreen Panel 1 v4 TR 2004004 AllergyScreen Panel 1 v4 UK 2039004 AllergyScreen Panel 160 v4 UE 021004 AllergyScreen Panel TPE v4 E 005004 AllergyScreen Panel 2 v4 D 005004 AllergyScreen Panel 2 v4 TR 005004 AllergyScreen Panel 2 v4 UE 036004 AllergyScreen Panel 2H w4 UK 2041004 AllergyScreen Panel 2KO vd UE 023004 AllergyScreen Panel ME v4 E 2025004 Allerguscreen Panel MENA vd LE 04004 AllergyScreen Panel TR v4 TR 04 004 AllergyScreen Panel TR v4 UE 06004 AllergyScreen Panel 3 v4 O 006004 AllergyScreen Panel 3 v4 TR 006004 AllergyScreen Panel 3 v4 UK Select test In the program O Select a test e Continue with Accept 2042004 AllergyScreen Panel SEO v4 UE ee Dees 2024004 Allerquscreen Panel SME v4 E 026004 AllergyS creen Panel 3ME NA v4 UE Accept gt gt 048004 AllergyScreen Panel 3TA v4 TR hd Camera contact The RIDA X Screen software starts the camera This procedure takes a few seconds 17 R Biopharm AG RIDA SCREEN PYYYYYY YT 9 PERFORMING AN EXAMINATION CAMERA PREVIEW PICTURE ADOPTION Camera preview In the program Adopt the picture with e Continue or break off with O Cancel Pictur
15. USER MANUAL FOR RIDA X Screen rbiopharm f C e Urgently to be read before initial operation e Observe safety instructions RIDA SCREEN 2000000 DESCRIPTION OF CONTENT Chapter 1 General 2 Equipment supplied e Remarks 3 Technical specifications Storage Settings 4 System requirements 4 System requirements Software installation 4 System requirements system check 5 User administration program start user login 5 User administration user profiles 5 User administration user profiles icons 5 User administration user profiles options 6 Menu bar Program options 7 Adding a new test 8 Adding a new patient opening changing patient s data 9 Performing an examination prepare measurement 9 Performing an examination new examination opening changing pa tient s data 9 Performing an examination camera preview picture adoption 10 Measurement and Evaluation measurement data current or prior measurements 11 Deleting a patient deleting patient s data 12 Deleting an examination deleting single measurements 13 Import Export of examinations data transfer saving data 14 Printout of results preview printout 15 Extras settings graphic modus address 16 Control sample quality control 16 Control sample quality control record 17 Troubleshooting Maintenance 18 Licence conditions R Biopharm AG Page CO N OD
16. d the corresponding user manual Scope of use R BIOPHARM AG grants a single non exclusive and personal right to use the enclosed copy of software on one computer and to use it only at one work station license A licensee is allowed to record the software in corporeal form from one computer to another i e recorded on a data carrier provided that it will be used only on one single computer at any time Parallel use on two or more computers is strictly forbidden Special conditions Without previous written approval from R BIOPHARM AG the licensee shall not surrender the software to a third party or allow access to it nor shall he send the software via net or other data transmission channels to another computer It is also forbidden to copy alter translate re develop decompile disassemble or develop derived products neither software nor written material without prior approval from R BIOPHARM AG Ownership of rights By purchasing this product you are given the sole ownership of the corporeal data carrier which the software is recorded on A right of owner ship of the software itself is not included R BIOPHARM AG has all rights reserved e g rights of publication copy handling adaptation and utilization Duplication Software and written documentation are copyright protected As far as the software is not provided with a copy protection you are allowed to generate one single copy for security purposes only You are obliged to install
17. duction of a usable software as per sentence 1 is not possible within an adequate expenditure range R BIOPHARM AG is not responsible for damages unless a damage is the result of intention or negligence by R BIOPHARM AG Liability for gross negligence is excluded towards businessmen The liability regarding assured characteristics remains untouched Liability for non insured subsequent damages is also excluded Place of Jurisdiction German law only applies to this contract The place of jurisdiction is Darmstadt Germany Concerning questions regarding these licence conditions please contact R BIOPHARM AG AG An der Neuen Bergstr 17 64297 Darmstadt Germany R Biopharm AG
18. e adoption The results appear on the screen after a few seconds Preview QC 71 w50 UR _ X Cancel Continue RIDA X Screen Rel 615f User Administrator Panel 1 v50 UK v66 28 02 2011 17 35 57 Q Fie Extra Window Help le x nen examination al Losa Patient Emo E rosa Report e Print Ze Exit Name QC 5496 5525 DOB 28 02 2011 ID ime Patient Sample 28 02 2011 Qc 21 28 02 2011 17 35 09 ac 21 28 02 2011 11 41 19 ac 21 28 02 2011 11 41 06 ac 21 28 02 2011 11 40 57 ac 21 28 02 2011 11 36 32 analysed tes a ac 21 28 02 2011 11 36 11 i ac 21 28 02 2011 11 31 32 ac 21 28 02 2011 11 31 15 strip cassette en aem m ac 21 28 02 2011 11 27 51 ac 21 28 02 2011 11 27 32 ac 21 28 02 2011 11 27 15 ac 21 28 02 2011 11 24 09 aczi 28 02 2011 11 23 56 i ac 21 28 02 2011 11 23 44 o ac 21 28 02 2011 11 19 06 ensitometry evaluation ac E ac 21 28 02 2011 11 18 41 ac 21 28 02 2011 11 13 46 ac 21 28 02 2011 11 13 20 ac 21 20 02 2011 11 12 49 59 ac 21 28 02 2011 11 02 44 ac 21 28 02 2011 11 02 36 0 ac 21 28 02 2011 11 02 22 ac 21 28 02 2011 10 57 28 QC 21 28 02 2011 10 57 10 ac 21 28 02 2011 10 56 52 0 00 e calculated values el Meat Ha ac 21 28 02 2011 10 56 13 5 ac 21 28 02 2011 10 56 04 a ac 21 28 02 2011 10 55 55 0 00 ac 21 28 02 2011 10 55 46
19. el 4 v50 BG Panel 4 50 D Panel 4 v50 E Panel 4 v50 F Panel 450 H Panel 4 50 MK Panel 4v50 PL Panel 4v50 RO Panel 4 v50 RUS Panel 4v50 TR Panel 4v50 UK Panel 4KO v50 UK Panel IR1 v50 UK PanelHVEN v50 H Panel HYEN v50 MK Panel HYEN v50 UK QC 21 v50 UK All tests released from the manufac turer are depicted in the Test Explorer window e By clicking on Select all you can select all tests e By clicking on Unselect all you can call off all selected tests O By clicking on Select invers you can convert all selected tests into not selected tests or convert all not selected tests into selected ones e Continue with Accept SILSILSILSILSILSILSILSILSILSILSILSILSILSILSILSILSILSILSILSILSILSILSILSILSILSILSILSILSILSILSILSILSILSILS M Install test Remove test o SelectAll UnselectAll SelectInwvers Cancel Accept Caution If this window pops up asking for a sys tem key number it is a sign that the RIDA X Screen has not been con nected properly to the computer used MESSUTES a a e Shut down computer e Connect RIDA X Screen to the PC e Start software again 13 R Biopharm AG RIDA SCREEN e The blue running bar and the test text inform about the installation process of the tests Su O The installation may take a few seconds After completion of the installation a test report is depicted for all installed tests e Continue with OK
20. f sun or light Please pay attention for the operating and storage temperature Please follow the installation instructions On the rear side of the the RIDA X Screen a Warranty Seal is adhered This seal serves to prohibit unauthorized unscrewing or dismantling of the the RIDA X Screen device Breaking of the Warranty Seal is considered to be a breach of warranty Warranty claims will not be accepted if the Warranty Seal is broken 5 R Biopharm AG RIDA SCREEN 2000000 4 SYSTEM REQUIREMENTS System requirements e Operating system Windows XP Windows Vista Windows 7 all 32 Bit versions See Operating System requirements Win NT Win 98 98 SE Win ME Win 2000 are not supported O Hard disk space 10 GB CD ROM 24x speed or better Display resolution min 1024x768 16 bit colour or better o 1 free USB port 4 SYSTEM REQUIREMENTS SOFTWARE INSTALLATION Installation e First keep the RIDA X Screen disconnected e Put the enclosed RIDA X Screen program CD in your CD drive e f your system supports Autorun the setup program will launch itself Oo f not e go to START RUN e type in X install X letter of your CD path e then press ENTER After installation of the software please connect the RIDA X Screen device with a free USB port of your PC To interrupt power supply remove the USB plug of the RIDA X Screen from the PC USB port R Biopharm AG RIDA SC
21. he test strip holder Do not use acid agents or membrane and depressions by using ordinary labo solvents holder ratory detergents disinfectant Please use scratch free wipes R Biopharm AG 28 RIDA SCREEN 1000000 18 LICENCE CONDITIONS License Agreement Preface The following conditions for your use of the RIDA X Screen READER SOFTWARE apply to end users licensee By opening the sealed data carrier package you agree to the following licence agreement Please read this agreement carefully If you do not agree to the conditions mentioned below you are not allowed to open the sealed data carrier package In this case do not open the pack age and return it immediately as well as all other parts of the purchased product including all written documents or material hardware components and packing to the place you bought it from Conditions of Contract 1 10 11 29 Subject of contract Subject of this contract are the following components the computer program recorded on a data carrier CD the user manual related hard ware components and written material These components are referred to as software R BIOPHARM AG explicitly states that based on today s technology it is not possible to issue a software in such a way that it is free of mis takes in all applications or combinations possible The product can thus be described as a software which can generally be used as per its de scription an
22. hen importing is already on the PC Image of test membrane The test membrane cassette Insert the test membrane cassette properly cassette seems off cen wasn t inserted accurately into the holder ter or slope Retry the examination Image of test membrane The holder wasn t inserted en Insert holder completely cassette seems very ey Retry the examination light or overexposed Assessment is com The wrong test membrane Insert correct test to the test list pletely impossible cassette or the wrong test Select the correct test for examination was selected Retry the examination There is no visible light Lack of power Check the connection between the a inside the RIDA X RIDA X Screen and the USB Port Screen device Installation under Win Lacking administrator rights You need to log in as administrator to ha 2000 is not possi be allowed to install e Enter System Key num RIDA X Screen has not Exit the software ber been connected properly to Shut down computer mle COMPARIRE Connect RIDA X Screen to the PC otart software Maintenance Standard maintenance is not designated for the RIDA X Screen In case of trouble or defective control samples please contact R BiopharmAG Telephone 49 0 6151 8102 0 Cleaning of case Wipe the case by using ordinary labora e Do not use acid agents or tory detergents disinfectant solvents Please use scratch free Cleaning of test Wipe and wipe out t
23. iopharm AG RIDA SCREEN 1000000 9 PERFORMING AN EXAMINATION PREPARE MEASUREMENT Patient s data Make sure that the patient s data are acquired in the data base Prepare measurement Correct After the end of the reaction time also see test conduction please insert the test membrane into the holder of the RIDA X Screen Remark Please pay attention to a correct insert of the test membrane into False the test membrane holder Please put the test membrane into the depression the way it fits evenly exactly and appropriately Pay attention not to touch the sur face of the membrane The test membrane holder has to Correct be pushed in exactly into the RIDA X Screen Please take care for a complete closing of the test membrane holder False R Biopharm AG 16 RIDA SCREEN 1000000002 9 PERFORMING AN EXAMINATION NEW EXAMINATION OPENING CHANGING PATIENT S DATA Choose patient Set Hew Examination Name Firstname Date of birth 22 22 2777 ALL aB cD EF GH w KL MN oP aR st Juvw xyz f Lastname Firstname Group Date of bith In the program AB BERND A CE BEN MUSA RAINER 15 07 64 JUDITH 15 12 72 M E N U BAR WILLI 12 03 85 CHRISTA 21 06 02 SVEN 12 10 75 bd CAL 01 10 02 SENEM 12 07 72 TORSTEN 01 12 72 NEW EXAMINATION T mE LILLI 26 03 02 Delete TINA 26 03 02 KLAUS 26 03 02 Add SIMONE 26 03 02 K NAST 26 03 02 Change C hoose a patie nt Street
24. lity R BIOPHARM AG grants to the original license that at the time of providing the data carrier which the software is recorded on and the respec tive hardware all components work faultlessly under normal operating conditions and with standard maintenance If a data carrier CD or hardware should be defective within the warranty period of 24 months the buyer may ask for a replacement He shall return the CD the re spective hardware any spare copy and written material as well as provide a copy of the corresponding invoice or receipt Should a defect arise as per this sentence 10 which cannot be solved by replacing components within a reasonable period of time the buyer is entitled to ask for a reduction in price or cancellation of the contract R BIOPHARM AG does not grant entirely faultless software due to the reasons mentioned in sentence 1 of this contract R BIOPHARM AG does not warrant that the software entirely meets the purpose and request of the buyer himself or works without problems when it is combined with other software programmes chosen by the buyer The buyer himself is responsible for the correct choice and combination of products the results of the use of software as well as the results he intends to achieve or gets The same applies to the written material accompanying the software In case the basic software is not usable due to reasons mentioned in sentence 1 the buyer may cancel the contract The same applies to R BIOPHARM AG if pro
25. personal computer These tests cover the prod uct and scope of use of the Reader provided by the manufacturer This instrument only should be used for measurement and evaluation of tests released by the manufacturer The manufac turer excludes warranty when other tests are used Correct capture and treatment of the tests only is possible when the test used has been handled according to its instruction sheet Especially one should care for time limits and sample quantity as these factors have a great influence on the measurement results In case of samples taken of patient cases of emergency these sam ples can be examined at every time by interrupting the routine work and performing the examination according to the instruction sheet R Biopharm AG RIDA SCREEN 1000000 2 EQUIPMENT SUPPLIED e REMARKS Packing list 1 RIDA X Screen Reader instrument 1 Test membrane holder 1 CD ROM with RIDA X Screen Reader software 1 control sample User Manual Brief instructions ZG1101 Order Number Advice Should any piece of equipment be missing or damaged please contact your distributor IMPORTANT O Please read this manual entirely prior to first use e Follow the instruction closely e R Biopharm AG is not responsible for any damage occurring due to misuse or wrong handling of soft and hardware O See the license agreements for further details page 32 e Do not connect the RIDA X Screen reader device to the PC be
26. quency of measurements by using the control sample should correspond to the location and safeguard a closed con trol of the system These measurements should be entered into a separate table and a printout of the measurement values of the control sample should be archived See page 28 record of measurements of the control sample Performing control Control measurement is carried out by using the test QC 21 v50 UK measurement which is already preinstalled If the test is not installed please goto MENU BAR EXTRAS gt ADDTEST and proceed according to chapter 7 ADDING A NEW TEST Carry out the measurement according to chapter 9 PERFORMING AN EXAMINATION Printout of the operator If the person who has performed the control panel and or the person and or QC Manager who Is responsible for the quality control the data of these persons and the codes can be entered in the address in the lower part See page 24 Address 25 R Biopharm AG RIDA SCREEN 10000000 Measuring range The measurement below is an example and interpretation Line 1 L1 gt passed failed Line 2 L2 gt passed failed Line 3 L3 gt passed failed Line 4 L4 gt passed failed When failed is stated in one or more lines the result is out of specification Contact your technical support or distributor R Biopharm AG Telephone 49 0 6151 8102 0 Patient Sample 983397698829 45411 5 Control sample Line Value QC
27. revocably O Use Yes e Now the patient s data are no longer available 19 R Biopharm AG RIDA SCREEN 12 DELETING AN EXAMINATION DELETING SINGLE MEASUREMENTS Load patient o Measurements which were saved or archived can be recalled by clicking the entry in the exam list Deleting measurement data Load the measurement which is going to be deleted e Click on the result domain with the right mouse button e The button Export gt Delete appears gt Click on delete Confirmation e The measurement data chosen will be deleted irrevocably Oo Use Yes O Now the measurement data are no longer available R Biopharm AG RIDA X Screen Rel 615f User Adminis el 2 v Fie Esra Window Help New eceminaion qu tons Patient EB monjen Era Renon Pin W k Exit Name PUBLIC JOHN trator Panel 2 v50 UK v66 28 02 2011 17 51 27 Q DOB 01 01 2001 ID A 28 02 2011 i AS P2 28 02 2011 17 50 40 Ti Allerg IU ml Class Allerg IU ml Class D1 2 65 2 6 M1 0 00 0 0 D2 3 3 0 M2 5 45 3 1 T2 13 24 3 6 M3 0 00 0 0 T3 11 90 3 6 M6 6 71 3 2 TA 10 82 3 5 17 37 3 9 x gt 100 6 0 G12 gt 100 6 0 15 06 3 8 5 60 3 1 El 2 12 25 E3 2 97 28 E5 0 26 0 7 E6 0 43 1 2 E84 0 00 0 0 E82 0 00 0 0 Contro 100 6 0 T lid Comment Screen Rel 615f User Administrator Panel 2 v50 UK v66 28 02 2011 17 51 27 p File Extra Window Help 114
28. t of several measure ments Fie Eta window Help Bro Examination a Load Patient E meonExpon B Name QC 5496 5525 DOB 28 02 2011 1D Select all measurements you e i want to printout and click in the 0c 21 E E list with the right mouse button 4 RT click on Selected and then on Print a 28 02 2011 28 02 2011 28 02 2011 Now all measurements will be printed as single reports 21 m 23 R Biopharm AG RIDA SCREEN 15 EXTRAS SETTINGS GRAPHIC MODUS ADDRESS Settings The EXTRA option allows you to alter several settings Address You can edit the address of the location at which the examination is performed IN the program MENU BAR ww Extras Change address R Biopharm AG E Y RIDA X Screen User Administrator File Extra Window Help Add Test Change Change Display Resolution ImportfEx Change Address Language Name l User English Advanced Spanish Portuguese French Italiar Turkishly far Company facattan Adoress Company R Biopharm AG Street An der Neuen Bergstra e 17 City Darmstadt State ZIP 64297 Country Germany Tel 49 6751 8102 0 Fax 49 6151 8102 40 Website e mail Cost Center Number Certification QA Manager 0A Code QC Manager QC Code
29. talled A printer IS No printer installed installed and connected to a port This printer will be It is strongly recommended to install a printer for the printout of the results used as an output unit for the software R Biopharm AG RIDA SCREEN 1000000 9 USER ADMINISTRATION PROGRAM START USER LOGIN User administration User login R Biopharm AG The RIDA X Screen offers a comfortable user administration Therewith every user can choose and equip program functions and program options individually and flexibly After program start O type in user name O type in password Advice At the first program start the administrator login with the password admin please type in admin in lower case letters Recommendation Choose a new password after the first program starts In the program see picture next page EXTRA CHANGE ADVANCED USER ACCOUNT MODIFY USER ACCOUNT Login RIDA X Screen proceed login by using Administrator Continue BAN The program starts by using the correct pass Error none word and the settings E which were defined by x Cancel ee Continue the user RIDA SCREEN 10000000 5 USER ADMINISTRATION USER PROFILES User profiles With the program module User account you can add modify or de lete an user account quickly and easily In the program EXTRA CHANGE ADVANCED USER ACCOUNT RIDA X Screen User Administrator File
30. te of birth 22 22 2777 ALL AB cD EF GH W KL MN oP 08 sT Juvwxv2 Adding a patient Lastname Firstname Group Date of birth A 15 10 58 BEN 111271 In the program RAINED 150764 JUDITH 15 12 72 WILLI 12 03 85 CHRISTA 21 06 02 SVEN 1210 75 MENU BAR CAL 01 10 02 SENEM 12 07 72 lt j TORSTEN 01 1272 NICOLE 15 1272 LILLI 26 03 02 Delete TINA 26 03 02 NEW EXAMINATION KLAUS 26 03 02 Add SIMONE 26 03 02 KUNAST 26 03 02 Se Street UNISTRASSE 4 State BERLIN ae City BERLIN County DEUTSCHLAND e click on Add to confirm zip 10789 Ip 15656 145640 Accept Practice mode Type in the patient s data FirstName JOHN Name mH ate irth 19 02 1966 ex MALE y O Type in the patient s data et g First Name Name Date o a Of Birth Sex into the form Street MAIN STREET 14 City UPTOWN ZIP 78457 O clickon OK O Now you can perform an County examination with this patient OK Cancel e To edit the data of an existing patient click on Load patient change and type in the new data New measurement E Laboratory mode Se O Type in the laboratory s data Working list EERE Een aA 0 Type in the laboratory s Type of Test AllergyScreen Panel 3 D TST data into the form Lotit K030325 O clickon OK Sample ID 12345 6799 e Now you can perform an Date 04 04 2003 examination with these laboratory s data Cancel 15 R B
31. tween RIDA X Screen Readers Allows to select the printer Allows preview of a printout Closes the program Cascade Cascades all open windows Tile Tiles all open windows Close all windows Closes all open windows Show exam list Shows all open windows Technical support Shows the address of the technical support con cerning help about the RIDA X Screen software Change LANGUAGE Select desired languages gt ADVANCED Mode Measurement gt Practise Laboratory gt Path Service Module gt Sample ID gt on off gt User Account see chapter 5 Change address Edits the data of the performing laboratory Shows copyright information R Biopharm AG 12 RIDA SCREEN 1000000 7 ADDING A NEW TEST System Key Each test membrane holder and RIDA X Screen has got its own system key This key already has been en tered while installing New Test 3 RIDA X Screen User Administrator File Extra Window Help In the program Change MENU BAR Change Address VW EXTRA ADDTEST The camera will detect the correct RIDA X Screen de vice automatically A window will open automatically Panel 3 v50 MK Panel 3 w50 PL Panel 3 v50 RO Panel 3 v50 RUS Panel 3 v50 TR Panel 3 v50 UK Panel 3DOHA w50 UK Panel 3H v50 H Panel 3H v50 UK Panel 3KO v50 UK Panel 3ME w50 E Panel 3IMENA w50 F Panel 3IMENA v50 UK Panel 3TRv50 BG Panel 3TRv50 MK Panel 3TR v50 TR Panel 3TRv50 UK Panel 3VE w50 E Pan
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