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RIDA X-Screen Manual ENG 591 englisch - 0401-RR-0009-07

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Contents

1. o e E ome Pe e PE 000 E RIDA CONTROL SAMPLE QUALITY CONTROL RECORD 28 Control Panel Caution Content Procedure 29 RIDA X Screen 17 CONTROL PANEL QUALITY CONTROL The control panel is provided by the manufacturer and serves to verify the measuring intervals and the light value of the corresponding camera The determination of the additional control panel is to be operated only in case that the camera is not working properly or you are requested by R Biopharm Please perform the determination of the control panel as described below before sending an inquiry or complaint about the RIDA X Screen to the manufacturer Without the data of the control panel a complaint cannot be accepted See Procedure below Within each camera box you will find additionally to the RIDA X Screen camera and the cal strip showing 4 greyish bands a camera specific control panel showing 21 greyish bands The camera and the control panel share the same serial number Therefore the control panel must be used in combination with the corresponding camera only The control panel should be measured with the corresponding camera for the below mentioned rdf calibration file in five independent measurements Please use rdf file Panel 2vxx UK For each single measurement the trough must be removed and replaced in the camera
2. X Screen License Agreement The following conditions for your use of the RIDA X Screen READER SOFTWARE apply to end users licensee By openin g 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 package and return packing to 10 11 it immediately as well as all other parts of the purchased product including all written documents or material hardware components and the place you bought it from Conditions of Contract Subject of contract Subject of this contract are the following components the computer program recorded on a data carrier CD the user manual related hardware 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 mistakes in all applications or combinations possible The product can thus be described as a software which can generally be used as per its description and 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
3. Advice Atthe 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 BUS NEN The program starts by using the correct pass word and the settings which were defined by the user Administrator Cancel 9 USER ADMI NI STRATI ON PROGRAM START USER LOGIN RIDA X Screen 5 USER ADMINISTRATION RIDA USER PROFILES 7242 2 X Screen User profiles With the program module user administration you can add modify or delete an user account quickly and easily In the program EXTRA CHANGE ADVANCED USER ACCOUNT RIDA X Screen User Administrator File Extra Window Help Add Test Change Change Display Resolution Change Address Language k Name User Advanced Camera k Test Mode Measurement Paths Probe Survey Already established user profiles will be shown with name and Status active YES NO see below User status Active status YES The user is able to start the program Active status The user is not able to start the program User Account Administrator RIDA X Screen USE
4. 444 ik s ds 4a TT HHC EI 2 4 Ux LL BUS w WH on ws aun LI Ka es 11 Cisr Jai GR woke 19 PERFORMING EXAMINATION CAMERA PREVIEW PICTURE ADOPTION RIDA 10 MEASUREMENT AND EVALUATION RIDA MEASUREMENT DATA e CURRENT OR PRIOR MEASUREMENTS X Screen Measurement data 10 09 2007 11 57 27 User Administrato 8 Prior measurement e Examinations which were saved or archived can be recalled by clicking the entry in the exam list gt clicking on exam list MEASUREMENT AND EVALUATI ON MEASUREMENT DATA CURRENT OR PRI OR MEASUREMENTS RIDA X Screen 20 RIDA 11 DELETING A PATIENT TO DELETING PATIENT S DATA X Screen Deleting a patient In the program MENU BAR VW NEW EXAMINATION Choose the patient who is going to be deleted e Use DELETE Confirmation RIDA X Screen Are the date af ite palies e e chosen patient s data will be deleted irrevocably e Use YES e Now the patients data are no longer available 21 DELETI NG A PATI ENT DELETI NG PATI ENT S DATA RIDA X Screen 12 DELETING AN EXAMINATION RIDA DELETING SINGLE MEASUREMENTS X Screen Load patient 3 ge bs ed T now IT Emm cuc om Measurements which were saved D 4 a or
5. 9 performing an examination CONTROL SAMPLE QUALITY CONTROL 26 RIDA 16 CONTROL SAMPLE X Screen QUALI TY CONTROL Measuring range The measurement below is an example and interpretation Line 1 L1 Test passed test failed Line 2 L2 4 Test passed test failed Line 3 L3 4 Test passed test failed Line 4 L4 4 Test passed test failed When test failed is stated in one or more lines L1 to L4 the result is out of specification Contact your technical support or distributor Telephone 49 0 6151 8102 0 R Biopharm AG Control sample Handling Note control sample e UL ENKE control sample should be stored at room temperature in a dark and dry place in the original package Record the date opened the package However after the first measurement the control sample Should not be used longer than 6 months Do not use control card beyond the expiration date printed on the package You can obtain new control samples from your distributor R Biopharm AG e Telephone 49 0 6151 8102 0 27 CONTROL SAMPLE QUALITY CONTROL RIDA X Screen 16 CONTROL SAMPLE RIDA QUALITY CONTROL RECORD aa X Screen User Further proceeding when test Abbrev signature generated failed EE __ eMe eee 6 Yes No ok failed oo e el o
6. 3MEMA v1 Allerqu5 creen Panel 1PE v1 E AllerqyS creen Panel 1 1 D AllergyS creen Panel 1 v1 TR AllerqyS creen Panel 1 s1 AllerqyS creen Panel 2 v1 D A lergyS creen Panel 2 v1 TH AllerqyS creen Panel 2 v1 AllerqyS creen Panel 3 1 D AllerqyS creen Panel 3 1 TR AllerqyS creen Panel 3 1 UK AllergyS creen Panel 4 v1 D Allergy S creen Panel 4 vi AllerqyS creen Panel 4 1 UK AllergyS creen Panel 1T v1 LIE AllerqyS creen Panel 2TR v1 TR AllerqyS creen Panel 2TR v1 UK AllergyS creen Panel v1 TH Allergy 5 creen Panel 3TA v1 AllerqyS creen Panel 2H v4 UK Allergy 5 creen Panel 1KO v4 UK AllerqyS creen Panel 260 v4 UK Al lergyS creen Panel v4 UK AllergyS creen Panel 4 v4 AllerqyS creen Panel v4 Remove test Info Install test Select All Unselect Select Invers Cancel Continue ADDING A NEW TEST 14 RIDA X Screen The blue running bar and the test 7 ADDING A NEW TEST RIDA X Screen User Administration File Extra Window Help text inform about the installation process of the tests Examination qu Load Patient SC E Print Exit Name Date of birth ID e Theinstallation may take a few seconds e After completion of the installation a test report is depicted for all installed tests e Use OK Report TEST wl CAL 05 v1 UK AllergyS creen Panel 2H v1
7. Add test Adds a new test by using the key number Inthe program EXTRA ADD TEST Change patient s data Changes the patient s data or other data base information 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 samples 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 RIDA USER ADMI NI STRATI ON USER PROFILE OPTIONS 12 13 RIDA 6 MENU BAR PROGRAM OPTIONS X Screen nen mmm reenen EE Adds new test using the key number Change CHANGE DISPLAY RESOLUTION RESOLUTION Changes the graphic resolution LANGUAGE ENGLISH GERMAN Selects Change address Edits the data of the performing laboratory Technical support Shows the address of the technical support concerning help about the RIDA X Screen software About 0000000 Shows copyright information MENU BAR PROGRAM OPTIONS RIDA 7 ADDING NEW TEST System Key New Test In the program MENU BAR ww EXTRA ADD TEST In the program e The system key a
8. UK AllergyScreen Panel 1KD v1 AllergyScreen Panel 260 v1 UK AllergyS creen Panel v1 UK AllergyS creen Panel 460 1 UK AllergyS creen Panel 2 v1 AllergyScreen Panel 3ME v1 E AllergyS creen Panel 2 vi LIE Allergy creen Panel vi UK AllerquS creen Panel 1PE v1 E AllerquS creen Panel 1 vi D AllerquS creen Panel 1 1 TR AllerquS creen Panel 1 v1 UE Allergy Screen Panel 2 v1 D Allerqy5 creen Panel 2 v1 TR AllerquS creen Panel 2 v1 Uk Allerqu5 creen Panel 3 v1 D AllerguS creen Panel 3 v1 TR Allergy Screen Panel 3 v1 UK AllerqyS5 creen Panel 4 v1 D AllerquS creen Panel 4 1 TR AllergyS creen Panel 4 v1 AllergyScreen Panel 1T v1 AllerqyScreen Panel 2TR v1 TR AllergyS creen Panel 2 v1 UK AllergyScreen Panel 3TA v1 TR AllerguS creen Panel 3TA v1 UK AllerqyS5 creen Panel 2H v4 UK AllergyS creen Panel 1KO v4 UK AllerquS creen Panel 2K0 v4 UK AllerguS creen Panel 3KO v4 UK AllerqyS creen Panel 4 LIE Allerqy5 creen Panel 2 v4 E Info Testinstaled Test removed AllergyScreen Panel 3 v1 done 15 ADDI NG A NEW TEST RIDA X Screen 8 ADDING NEW PATIENT OPENING CHANGING PATIENT S DATA Adding a patient In the program MENU BAR NEW EXAMINATION click on to confirm Practice mode Type in the patient s data Type in the patient s data into the form e DE Now can perform examination with this patient T
9. 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 including 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 liability 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 respective hardware all components work faultlessly under normal operating conditions and with standard maintenance If a da
10. archived can be recalled by clicking the entry in the exam list Deleting measurement data load the measurement which is going to be deleted Click on the result domain with the right mouse button The button Delete appears gt Click on delete Confirmation RIDA X Screen The measurement data chosen will Are the date af ihe patient te be srevocebily deleted be deleted irrevocably Use Now the measurement data are no longer available RIDA aA 5creen OLARE SOAP RIDA X Screen DELETING AN EXAMI NATI ON DELETING SINGLE MEASUREMENTS 22 RIDA 13 IMPORT EXPORT _ _ OF EXAMI NATIONS X Screen DATA TRANSFER SAVING DATA Data transfer You can import and export the examination data of any patient to and from any destination on the local drive or on your network So you can exchange the results of the measurements between different RIDA X Screen Reader systems Data transfer m Ai imporyexpon Print In the program ASCII MENU BAR RM IMPORT EXPORT Select either ASCII or Reader Busan xj G Export ASCII CARAPIDYIEXPORT CALIBRATION Probe 03041 00006734 Test Allergy Screen Panel 2 v4 7 0 D4TE 05 04 20044 TIME 14 20 04 45C created When having selected ASCII export is generated automatically Confirm by clicking on OK When having selected READER Export Reader RIDA X Screen File k x Choose directory cd Sa EXPOR
11. 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 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 redevelop 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 ownership 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 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
12. R ADMI NI STRATI ON USER PROFILES 10 RIDA X Screen Icons 11 5 USER ADMINISTRATION USER PROFILE ICONS The options of the user administration are accessible by using the following 4 icons Modify User Account Changing the functions of an user profile Delete User Account Deleting an old user profile Close User Account Leaving the user administration Ler Username Fassmord Password conim Acte O Administrator LJ Add test Change patient data lvl Comm ente _ Delete exnmminatian CI Delete patient expor C Examination impari L Examination validation Meacuramatt Printout ei Sample 10 modity USER ADMI NI STRATI ON USER PROFILE ICONS Add User Account Adding a new user profile Add User Modify User is activated a window for changing the user profile appears RIDA X Screen 5 USER ADMINISTRATION RIDA USER PROFILE OPTIONS DE SZ S X Screen OPTIONS DESCRIPTIONS User Name of the user Allowed signs 4 2 0 9 Password Type in password Allowed signs A 4 2 0 9 Password confirm Type in password Allowed signs A Z a 2 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 cannot be deleted
13. S TET P 104 769 Colors True Color 32 Bit 1024x758 Colors True Color 32 Bit X Cancel Edi Company Adoress Company Street City State ZIP Country R Biopharm An der Neuen 17 Darmstadt 64297 Germany Te FAX Website e mail Cost Center Number 43 6151 8102 0 49 6151 8102 40 Certification QA Manager Code QC Manager QC Code Reader ID Signature EXTRAS SETTI NGS GRAPHI C MODUS ADDRESS 24 RIDA 15 PRINTING OUT AN EXAMINATION __ PRINT PREVIEW PRINTOUT X Screen Preview printout You can activate the preview and printout by using the icon Print in the respective window Preview the program e The result is shown in the window USING THE ICON Mame JOHN Q iD 135 noa uj d Tt PRINT PREVIEW Date 307 14 7 54 Tz T wk Eb P Coed DF pti keg wi EI EE E Allargen Allergen Cae waluadcn Lada Hanna Di ra mmt Jij E Iu Des Cep EI kabi abida 1122 E bebe ERT RI Printout pas TM In the program Away Report P The printout is shown in the window
14. T Save file File name File tup Reader FILE BCD Cancel Schreibschutz offnen Saving data I xi Exporthile L RAPIDSERPURTSR Biapharmm TEST BUI created IMPORTANT d e tis recommended to run backups of the acquired data on an external storage system on a regular basis e The file might be sent to all RIDA x Screen 15675 Data can be shown at the receiver s places by clicking on import 23 I MPORT EXPORT OF EXAMINATIONS DATA TRANSFER SAVING DATA RIDA X Screen 14 5 SETTINGS GRAPHIC MODUS ADDRESS Settings The EXTRA option allows you to alter several settings Monitor resolution You can change the resolution of your monitor for maximum comfort Address You can edit the address of the location at which the examination is performed RIDA X Screen RIDA X Screen RIDA X 5creen User Administrator Change Change Address File Extra Window Help Add Test ES e Change Display Resolution ImportfExy German User English Advanced Spanish Portuguese French Italian Turkishly Allowed Graphic modi Afowed Graphic mO 000 600 Colors True Color Bit alib n0 Colors True Color 32 Bit 900600 Colors True Color 32 Bit 000x600 Colors True Color 32 Bit P SE EE UE ES us EE UO ETENIM Colors R
15. USER MANUAL FOR RIDA X Screen r Diooharm CE Urgently to be read before initial operation e Observe safety instructions DESCRIPTION CONTENTS RIDA X Screen Chapter Page 1 General 3 2 Equipment supplied e Remarks 4 3 Technical specifications e Storage Settings 5 4 System requirements software installation 6 5 User administration e program start user login 9 User administration e user profiles 10 User administration e user profiles icons 11 User administration e user profiles options 12 6 Menu bar Program options 13 7 Adding a new test 14 8 Adding a new patient opening e changing patient data 16 9 Performing an examination prepare measurement 17 Performing an examination e new examination 18 opening changing patient s data Performing an examination camera preview picture adoption 19 10 Measurement and Evaluation measurement data current or 20 prior measurements 11 Deleting a patient deleting patient s data 21 12 Deleting an examination e deleting single measurements 22 13 Import Export of examinations e data transfer e saving data 23 14 Extras settings e graphic modus e address 24 15 Printing out an examination print preview e printout 25 16 Control sample e quality control 26 Control sample quality control record 28 17 Control panel quality control 29 Control panel e quality control record 30 18 Troub
16. USING THE ICON ww PRINT PRINTOUT mood m ois um j t gen me Aiei e 2 EEEEHUBUUBSzSRUU d 25 PRI NTI NG OUT AN EXAMI NATI ON PRINT PREVI EW PRINTOUT RIDA 16 CONTROL SAMPLE QUALITY CONTROL Control sample Caution Performing control measurement RIDA X Screen RIDA X Screen 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 patient samples might be detected and or quality control can be carried out In case there has not been conducted a documented continuous examination by using the control sample the manufacturer excludes every warranty for the measurement values Frequency of measurements by using the control sample should correspond to the location and safeguard a closed control 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 Control measurement is carried out by using the test CAL 05 v2 UK RDF and is already preinstalled together with all other tests Please go to MENUTASK EXTRAS ADDTEST And proceed according to chapter 7 adding a new test and carry out measurement according to chapter
17. again After this the mean value for each line has to be calculated and afterwards compared with the preset value as shown in the certificate of the RIDA X Screen The mean value should show a max deviation of 0 3 classes from the preset value on the certificate Evaluation of the control panel RIDA X screen Laboratory Serial No X Screen CONTROL PANEL QUALITY CONTROL RIDA 5 17 CONTROL PANEL RIDA QUALITY CONTROL RECORD pU X Screen Storage of the The control panel must be protected against camera specific control panel e light e humidity e fingerprints Please don t touch the surface of the membrane and store it in the included aluminium bag with silica gel Example The following picture shows one measurement of a control After five independent measurements the calculated mean value for each line can be compared with the given class value in the certificate of the RIDA X Screen I n case the mean value does not meet the specifications mentioned on the camera specific certificate please contact your local distributor RIDA CONTROL PANEL QUALI TY CONTROL EXAMPLE 30 RIDA 18 TROUBLE SHOOTING as MAINTENANCE X Screen i Message You tried to import a file that is The file is already on the PC target and source equal already on the PC when importing Image of test strip T
18. ct the RIDA X Screen reader device to the PC before 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 Bergstrafse 17 64297 Darmstadt Germany This manual has been edited conscientiously and complies with the Standard DI N EN 591 This user manual is effective from date of software version 490g Manual Version 0401 RR 0009 07 2009 05 06 RIDA X Screen EQUI PMENT SUPPLI ED 4 Dimensions Weight Physical data Consumption Storage and operating temperature Basic settings Measures of installation RIDA X Screen 3 TECHNICAL SPECIFICATIONS STORAGE SETTINGS This system can be applied according to the conditions of EN 61326 1997 A 1 1998 Class for emission and absorption 262 x 110 x 200 mm H x W xL 1 7 kg 5 V 0 5 Ampere maximally 2 5 Watt Storage temperature should not be under 0 degree and not over 50 degree Celsius Location or rather operating temperature of the instrument should not be under 10 degree and not over 40 degree Celsius The factory made basic settings are conducted by the set up routine and can be verified in the manual chapter control sample quality cont
19. est strip holder Enter licence number x In case no second part 2 LASTER key number is available 554453753794 4651 0 ID please enter 506989598488 45120 999999999999 99993 Use CONTINUE Follow the instructions second part key number 7 SYSTEM REQUIREMENTS SOFTWARE INSTALLATION SYSTEM CHECK I RIDA Screen SYSTEM REQUIREMENTS RIDA SOFTWARE INSTALLATION SYSTEM CHECK II X Screen System check The installation program tests all essential points of the installed components in the computer The RAPID READER has special system requirements Test function Error handling Operating System Windows Windows 3 1 95 98 985 ME Windows Vista 32 Bit detected The computer is not adapted for the installation of the software Error correction Installation of an appropriate operating system any existing data should be stored on external media Processor s Intel Pentium IV or better Processor 386 486 or higher has been Processor CPU Celeron detected type The speed of the CPU is not appropriate to install the software Error correction a newer faster processor should be used Less than 512 MB memory has been found The physical memory RAM should be RAM Windows XP Min 512 MB Windows Vist Min 1 GB increased to minimum 512 MB 512 MB or more recommended Graphic resolution Minimum 1024 x 768 Pixel Re
20. he test strip cassette wasn t Insert the test strip cassette properly into the cassette seems off inserted accurately holder Genter OrstOpe Retry the examination Image of test strip The Insert holder completely cassette seems very enurey Retry the examination light or overexposed Assessment is The wrong test strip cassette Insert correct test to the test list completely impossible or Select the correct test for examination the wrong test was selected Retry the examination There is no visible light Lack of power Check the connection between the inside the RIDA X RIDA X Screen and the USB Port Screen device Installation under Lacking administrator rights You need to log in as administrator to be allowed Windows 2000 iS not to install possible Maintenance Standard maintenance is not designated for the RIDA X Screen In case of trouble or defective control samples please contact R Biopharm AG Telephone 49 0 6151 8102 0 Cleaning of case Wipe the case by using ordinary laboratory notuse acid agents or solvents detergents disinfectant e Please use scratch free wipes Cleaning of test 4 Wipe and wipe out the test strip holder and e notuse acid agents or solvents strip holder depressions by using ordinary laboratory detergents disinfectant e Please use scratch free wipes 31 TROUBLE SHOOTING MAINTENANCE RIDA X Screen 19 LICENCE CONDITIONS RIDA PREFACE
21. leshooting e Maintenance 31 19 Licence conditions 32 RIDA Screen DESCRIPTION CONTENTS 2 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 RIDA 1 GENERAL X Screen The RIDA X Screen iS an instrument that evaluates the reflection or optical density of a biochemical reaction compared to the environmental 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 v reflected density 1 During the set up routine different tests released by the manufactu
22. o edit the data of an existing patient click Ud pa chande and type in the new data Laboratory mode Type in the laboratory s data Type the laboratory s data into the form Now you can perform an examination with these laboratory s data RIDA X Screen ADDING A NEW PATI ENT OPENING CHANGING PATIENT S DATA Explorer Set New Examination Lastname Firstname ALL ABEL BERND Steet MANSTREET UPTOWN State Country Po nm _ M Mew measurement RIDA X Screen Address EI Create New Patient First JOHN Name SMITH Date Of Birth 19 02 1966 Sex MALE D Patient ID 451 245 Group ZIP 78457 16 RIDA 9 PERFORMING AN EXAMINATION X Screen PREPARE MEASUREMENT Patient s data Make sure that the patient s data are acquired in the database Prepare measurement Correct After the end of the reaction time also see test conduction please insert the test strip into the holder of the RIDA X Screen Remark Please pay attention to a correct insert of the test strip into the test strip holder False Please put in the test strip into the depression the way it fits evenly exactly and appropriately Pay attention not to touch the surface of the membrane Correct The test strip holder has to be d pushed in exac
23. rer are transferred on the personal computer These tests cover the product and scope of use of the Reader provided by the manufacturer This instrument only should be used for measurements and evaluation of tests released by the manufacturer The manufacturer 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 samples can be examined at every time by interrupting the routine work and performing the examination according to the instruction sheet GENERAL RIDA X Screen 2 EQUIPMENT SUPPLIED e REMARKS RIDA X Screen Packing list 1 RIDA X Screen Reader instrument 1 Test strip holder 1 CD ROM with RIDA X Screen Reader software 1 control sample e 1 control panel e Manual e Brief instructions Advice Should any piece of equipment be missing or damaged please contact your distributor IMPORTANT e 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 See the license agreements for further details page 32 e Do not conne
24. rol The instrument should not be exposed to direct and permanent radiation of sun or light Please pay attention for the operating and storage temperature Please follow the installation instructions 5 TECHNICAL SPECIFICATIONS STORAGE SETTINGS RIDA RIDA X Screen 4 SYSTEM REQUIREMENTS SOFTWARE INSTALLATION System requirements Operating system Windows XP Windows Vista 32 Bit Win NT Win 98 98 SE Win ME are not supported e Windows XP 512 MB Vista Vista 1 GB e Celeron Pentium IV or better e Hard disk space 850 MB e CD ROM 24x speed or better Display resolution min 1024x768 16 bit color or better e 1 free USB port RIDA SYSTEM REQUI REMENTS SOFTWARE INSTALLATI ON 6 Installation System Key RIDA X Screen SYSTEM CHECK 4 SYSTEM REQUIREMENTS SOFTWARE INSTALLATION First keep the RIDA X Screen disconnected Put the enclosed RIDA X Screen program CD in your CD drive f your system supports Autorun the setup program will launch itself e f not e goto START RUN type in install X letter of your CD path e then press ENTER Each test strip holder has its own system key which has to be kept well The system key has to be entered during the installation routine Remark The system key is stipulated on the outer packing carton of the RIDA X Screen as well as on the bottom side of the t
25. s well as the number entered while installing appear Please enter the new system key number in case you wantto use another RIDA X Screen or another test strip holder In case no second part key number is available please enter 999999999999 99999 e Use CONTINUE In the program e clicking on Select all you can select all tests e Byclicking on Unselect all you can call off all selected tests e Byclicking on Select invers you can convert all selected tests into not selected tests or convert all not selected tests into selected ones e Use CONTINUE RIDA X Screen RIDA X Screen Each test strip holder and RIDA X Screen has got its own system key This key already has been entered while installing RIDA 5 User Administrator File Extra Window Help Change Change Address Enter System Key 1 ll SYSTEM KEY 554453753794 46510 7 4 506989598488 45120 lt lt Back Continue gt gt second part key number All tests released from the manufacturer are depicted in the Test Explorer TEST Explorer 05 v1 UK Allergy creen Panel 2H v1 UK W AllerquS creen Panel 1KD v1 UK AllergyS creen Panel 260 vi UK Al lergyS creen Panel vi UK AllerqyS creen Panel 4 v1 UK Allerqu5 creen Panel 2 v1 AllerqyS creen Panel SME v1 E AllergyS creen Panel 2 v1 LIE AllergyS creen Panel
26. screen Panel 2H v4 041004 AllergyScreen Panel v4 023004 AllergyS creen Panel v4 E 025004 AllergyS creen 2MEMA 4 LIK T U4 7004 AllergyScreen Panel 2TA v4 047004 AllergyScreen Panel 2TA v4 LIF 006004 AllergyS creen Panel 3 v4 D 7006004 Allergy S creen Panel 3 v4 TR 006004 AllergyScreen Panel 3 v4 LIE 042004 Allergyscreen Panel 3KD v4 UK 024004 Allerg creen Panel 3ME v4 E FUZ6O04 AllergyS creen Panel wd UK 7048004 AllergyScreen Panel 3TA v4 RIDA Name Firstname Date of birth 72 79 7777 Delete Add Change Cancel Accept C lt lt Cancel Accept gt gt RIDA X Screen software starts the camera This procedure takes a few seconds PERFORMING AN EXAMINATION 18 RIDA 9 PERFORMING AN EXAMINATION US CAMERA PREVIEW PICTURE ADOPTION X Screen Camera preview the program Adopt the picture with CONTINUE or break off with CANCEL Picture adoption abe ire The results appear on the diio ce ipd eran Fen een Hams PUBLIC JOHN DC dn ii aW iD 92346 screen after few seconds e analysed test strip cassette e densitometry evaluation Abee Wie Zeen owgan Alt Class ni 1 78 RT KR az e calculated values E mon D 22 Xr ER 16 31
27. solution 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 Current Colors The current settings do Refer to the manual Monitor Resolution not correspond to the required values but will be supported by the graphic card Hard drive free Minimum 850 MB 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 Graphic depth 16 bit or more Printer default Printer installed A printer No printer installed is installed and connected to a port This printer wil be used as an output unit for the software Printer installed List of the installed printers It is strongly recommended to install a printer for the printout of the results RIDA SYSTEM REQUI REMENTS SOFTWARE INSTALLATI ON SYSTEM CHECK II 8 RIDA 5 USER ADMINISTRATION PROGRAM START USER LOGIN X Screen User The RIDA X Screen offers a comfortable user administration administration Therewith every user can choose and equip program functions and program options individually and flexibly User login After program start type in user name type in password
28. ta 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 respective 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 rot 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 if production 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 RBIOPHARM AG Liability for gross negligence is excluded to
29. tly into the RIDA X Screen Please take care for a complete closing of the test strip holder False 17 PERFORMI NG AN EXAMI NATI ON PREPARE MEASUREMENT RIDA 9 PERFORMING EXAMINATION NEW EXAMINATION OPENING CHANGING PATIENT S DATA Choose patient In the program MENU BAR ww NEW EXAMINATION e Choose a patient e Clickon ACCEPT tocontinue Select test In the program e Selecta test e Use ACCEPT Camera contact RIDA X Screen NEW EXAMINATION OPENING CHANGING PATIENT S DATA X Screen Set New Examination AL cD EF B sr xyz Group Date of birth 15 10 58 111271 15 07 64 BEN RAINER BAR JUDITH B20 15 12 72 WILLI MTD 12 03 85 CHRISTA 820 21 06 02 SVEN MOR 12 10 75 CAL CAL 01 10 02 SENEM THC 12 07 72 TORSTEN AMP 01 12 72 NICOLE 1812 72 LILLI BAR 26 03 02 TINA MOR 26 03 02 KLAUS coc 26 03 02 SIMONE MTD 26 03 02 KUNAST 26 03 02 Street UNISTRASSE 4 City BERLIN zip 10789 ID 15656 145640 Select Test 004004 creen Panel 1 v4 D 004004 Allergy S creen Panel 1 v4 004004 AllergyS creen Panel 1 v4 LIE 7039004 AllergyScreen Panel 160 v4 AllergyScreen Panel v4 E 005004 creen Panel 2 v4 D 005004 AllergyScreen Panel 2 v4 7005004 AllergyS creen Panel 2 v4 036004 Allergy
30. wards 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 Neue Bergstr 17 64297 Darmstadt RIDA X Screen LI CENCE CONDITIONS 32

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