Home

Elisys Uno

1. Curve Based on Selected records The curve based upon the calibrators selected in the Curve box Select calibrators by clicking on the box to the left of the calibrator name Current Curve When the desired calibrators have been selected as shown above click on the Activate Selected button to accept The curve is displayed in the window The current curve will then be used for sample calculations Human gt as Diagnostics Worldwide 33 138 4 3 2 Sample Tab ri Elisys Uno EIA Mode af x Managemer Routines Lot Registration IC Tracking ample DE jettings ecurit He SE e AEO i w Enter sample IDs Choose tests Work list rack2 available positions 96 selected samples 0 ID Total 1 Test Current Calibration Status Test Reps Urgent 122 A 10ulS ample Incomplete No items to show A 10ulS ample Read Expired A Absorbance A Anti HA DiaSorin No Curve Incomplete A Anti HA DiaSorin short No Curve Incomplete A Anti HA DiaSorin _ No Curve Incomplete A Anti HAy_ No Curve Incomplete LA A Anti HBc DiaSorin No Curve A AntiHBc DiaSorin short No Curve Add Numerical ID A Anti HBc_ No Curve AntiHBe DiaSorin NoCuyk be ae eee er Lea refiz A will be automatically used to ra DiaSorin Curve differenciate numerical ID bd ID A B 2 Micro MixFix 3W ash A B 2 MicroG W ashtest No Curve A 8 2 Microgl MixFix Aa First 1D il A B 2 Microglobuli
2. Sep wal inital Eher Lino 6 2 inthe folowing Folder Tolima do vs folder obok Newt O A o Vonn henin raal E koe Uro 2 by ding Cancel la Figure 2 1 6 Choose Destination Folder vr E Elisys Uno Figure 2 1 8 Icons Appear on Desktop Elisys Uno 6 2 See nn r an have naang Go Mes ico vote Sean pap WAPRANG Thir pogaes a protected by copyright lar and Unedthoaned reproduction a duttuten of hier prog a sy py ll et ata cs Figure 2 1 5 Welcome to ELISYS UNO 6 2 Setup has finished installing Elisys Uno 6 2 on your computer Setup can launch the Read Me file and Elisys Uno 6 2 Choose the options you want below Click Finish to complete Setup Figure 2 1 7 Finish Installation x User ID Admin Password Cancel Figure 2 1 9 Admin Login Connect the power cord to the instrument then to an approved power source It is strongly advised that a UPS Uninterruptible Power Supply be used to avoid power interruptions to the ELISYS UNO and to the computer Human A A Diagnostics Worldwide 9 138 9 Place a rack onto each of the two rack holders The default positioning places the Reagent rack on the left and the Sample rack on the right Place the plate loaded with microwells into the plate carrier at the right 10 The program default is to use COM1 for communication with the instrument If connecting the instrument to a different port go to the Settings Menu and se
3. Add i Properties wA Remove El Remove All Human gt Diagnostics Worldwide 103 138 2 Standard Properties AE O Advanced Button Optional Mame TSH Calibrators Concentration 0 0 Minimum number to use 2 2 Figure 6 6 4 Standard Properties The Standard Properties dialog shows possible Advanced parameters for special cases NOTE To enter the concentration register a lot number for this standard in the ELISYS UNO Manager A Advanced Button Optional This should only be used if you need to set up different parameters than in the Add Sample Step Need Different Parameters than Add Sam ple S x NOTE Use this dialog only if you need to set different parameters than those set in Add Sample step Needs Different Volume l uL Needs Different Advanced Parameters Advanced Parameters Cancel Figure 6 6 5 Advanced Button Needs different volume Check this box if the Standard needs a volume that is different that the volume defined in the Add Sample Step When checked the Volume field is enabled Needs Different Advanced Parameters Optional Check this box if the Standard needs advanced parameter s different than those defined in the Add Sample Step When checked the Advanced button is enabled 104 138 Human Elisys Uno User Manual xi Aspiration Speed z Air Gap 2 Dispense Speed 2 E Dispense Height Lor
4. Assay Name New Assay El4 passa Made Type Ela JY Flat bottom wells Eut ai Formula Temperature PE Room Temp Cov X mean Nc Y mean Pcl F Assay Description 3 p 1 000 Y 1 000 EE 0 000 Figure 7 1 1 3 Assay Definition and Set Formula Variables COV X mean Nc F Use this equation if only a negative control is used to determine the COV COV Y mean Pc F Use this equation if only a positive control is used to determine the COV For interpretation you may chose either the Regular Cut Off Mode positive gt cut off negative lt cut off or the Reverse Cut Off Mode With the Reverse Cut Off option the Samples with values lower than the cut off are labelled as positive If you choose this option be careful to follow the lt and gt signs in the prompts for entering cut offs and ranges Human gt Diagnostics Worldwide 113 138 7 1 1 2 Cut Off Standard Mode ELISYS UNO reads a calibrator then calculates concentrations based on a single point standard curve passing through the point 0 0 A blank is required to determine the 0 0 point A factor equal to the concentration of calibrator the absorbance of calibrator is generated in this mode and then multiplied by subsequent absorbance readings to determine concentrations In the Cut Off Standard mode you may assign a concentration value to one of the controls to be treated as a calibrator and select cut offs
5. Diluent Volume Amount of diluent to be added to a Sample B ASPIRATION SETTINGS Aspirate Separately If this option is not checked both the diluent and the Sample are aspirated in a single step and then dispensed together to the vial on the sample rack Separation Air Pocket What should be diluted in addition to Samples o Dilute Standards Check this option if you want to dilute both samples and standards o Dilute Controls Check this option if you want to dilute both samples and controls o Use Diluent For Blank Check this option if you want to use the diluent for blanking C DILUTION MIXING IN RACK2 Mix by Aspirate Dispense o Mixes the dilution before loading by repetitive aspiration and dispensing o The number of times and the percentage of volume can be set Human gt ae Diagnostics Worldwide 91 138 6 3 1 2 Add Reagent CI Add Sample Min HCI pea I Albumin Reagent Mak Phos Reagent New Incubate Lag time E ee pet Read T BUN RI EUN R2 Clean Probe Rinze Probe WB Calcium 42 IIl Reagent Calcium Buffer Reagent Wash Welle Calcium CPC Reagent MA Chloride Reagent E Cholesterol Reagent MI Creatinine Buffer A1 Creatinine Picric A1 Creatinine R2 Creatinine Working Direct Rilinihin NCA z if Figure 6 3 1 2 1 Select or create a Substance Reagent Select Add Reagent from the list Select an existing Substance or Reagent or create a new one E Add Reagent Step Parameters xl
6. Assay Steps Add Step pastes Volume 100 0 uL Exclude Blanks When Dispensing Reagent Ai Delete Step Dispense One By One Cancel Advanced il Copy Step Figure 6 3 1 2 2 Add Reagent Step Parameters Change button Enables changing the reagent for this step Volume Desired reagent volume to be added to a well Exclude Blanks When Dispensing In common practice Blank wells contain a reagent only If you do not want to dispense the reagent into the Blanks check this option Dispense One By One ELISYS UNO tries to be as efficient as possible and aspirates the reagent for several samples at once If you want the reagent to be aspirated for only one Sample resulting in better precision for small reagent volumes check this option 92 138 Human Elisys Uno User Manual Advanced Button optional xi Aspiration Speed UT Air Gap 50 Frewarm Time 00 00 Dispense Speed Es Dispense Height High y Special Volumes ea _ Figure 6 3 1 2 3 Add Reagent Step Advanced Parameters Aspiration Speed The acceptable range is O to 4 The fastest speed is 4 Default speed is 2 Air Gap Amount of air in microliters that will separate the substance being aspirated from the de ionized DiH20 water in the diluter system Default values are automatically selected based on the aspiration volume Pre warm Time Most kinetic tests require the reagent to be pre warmed after aspiration and before it i
7. Figure 6 4 5 Positive Negative Reversed Human P Diagnostics Worldwide 99 138 6 5 Special Groups Assay Editor Assay View Substances Panels Indices Security Settings Help a ma ma y WHS AAN X Y a CHEM WY EIA AS Cte Std Assay Name Mew Assay El Assay Mode Standards Type EIA i Flat bottom wells Absorbance Temperature Room Temp JE Assay Description Assay Sheps Curve Valid Time Add Step Blank Blank Used Sample Run samples as doubles QC Criteria AE EEE Controls Add Interpretation Settings Urita Normal Range Positive Negative Cone of Decimals 1 kd el Special Groups Figure 6 5 1 Special Group Special Groups can be defined based on Age Gender or Keyword In Figure 6 5 2 Special Group Edit Menu Adult is defined as a patient who is greater than 18 years old To access Special Groups click on Normal Range see diagram box 1 in the Interpretation Settings section of the screen The Special Groups button see diagram box 2 will appear in the lower left hand corner of the screen 100 138 Human Elisys Uno User Manual The Special Groups Interpretation window will open A list of defined groups will display Defined groups may be added edited and deleted Special Groups Interpretation If Edit Group is chosen the Special Group Edit window will open The Group ID is the group definition Age range and gender may be selected Keywords should
8. Select all Progress Close The screen will display a message when the pack file operation has completed Pack Unpack a certain files to do migration Pack Unpack all root files for touble shooting r Direction t Pack C Unpack From root folder Action Pack ASSAY files To pck file AREA Roco lab_assap pok 1 Pack File R Rootilab_assay pck is created successfully VWesayeChen E sample Assays Example WesaysChem E sample Assays E sample VWwesapsChem E sample Assays E sample WesaysChem Example Assays E sample 3 A bere TS E a a Select all L I e ce EE The packed file will be located in the directory with the filename shown in the To display box on the screen Human gt Diagnostics Worldwide 49 138 4 4 8 3 About 3 Secunty Help Self Test Launch Assay Editor Launch Pack bottle Er The About selection will open a window and display the version of the ELISYS UNO Manager installed in your instrument A Elisps Uno 6 2 0 4710400 31 0 390 E Human Copyright C 2004 2005 50 138 Human Elisys Uno User Manual 5 Running ELISYS UNO This section will take you through the steps necessary to prepare for the day s work and set up a run using the ELISYS UNO Manager 5 1 General Settings When you first open the ELISYS UNO Manager there are several settings to choose from and a few tasks that must be performed before running samples 5 1 1 Au
9. 10 RK2 02 gt D04 4 T 5 10 05 4 08 32 PM Normal Control 0 176 Abs 95 1 mg dl 99 10 RK2 02 gt B01 2 T 5 10 05 4 08 32 PM Abnormal Control 0 584 Abs 315 6 mg dL 323 32 RK2 03 gt E01 3 T 5 10 05 4 08 32 PM Abnormal Control 0 574 Abs 310 2 ma dL 323 32 RK2 03 gt B04 1 L Example LDH T 5 10 05 4 08 32 PM Normal Control 0 0104 d amp bs min 125 IU L 157 32 RK2 02 gt F04 4 T 5 10 05 4 08 32 PM Normal Control 0 0118 d bs min 142 IU L 157 32 RK2 02 gt G01 3 T 5 10 05 4 08 32 PM Abnormal Control 0 0317 d bs min 381 IU L 407 81 RK2 03 gt G04 4 T 5 10 05 4 08 32 PM Abnormal Control 0 0328 d bs min 394 IU L 407 81 RK2 03 gt H01 3 L Performance Check T 5 10 05 12 38 17 PM 0 5N NaQH 0 0012 0 0017 RKO 0 gt 401 2 T 5 10 05 12 38 17 PM 0 5N NaOH 0 0005 0 0007 RKO 0 gt D01 3 T 5 10 05 12 38 17 PM 0 5N NaQH 0 0010 0 0015 AKO0 0 gt 404631 T 5 10 05 12 38 17 PM 0 5N NaQH 0 0017 0 0025 RKO 0 gt D04 4 I 5 10 05 12 38 17 PM Medium Sample 1 4344 1 4411 RKO 0 gt B01 2 T 5 10 05 12 38 17 PM Medium Sample 1 4479 1 4424 RKO 0 gt E01 3 I 5 10 05 12 23 17 PM Medium Sample 1 4442 1 4391 RKO 0 gt B04 1 5 AAN 17 28 17 PM Meriva Saranle 1 ARAR 14781 a T Select all T Fold all Sor by Test y Print Previews Pritt Erpat Remove Retest Layout kS Calibration A Sample gO Testlist Report 1 Select All Check this box to select all Names IDs Only selected results will be printed 2 Print Print all selected Results 3
10. Remove Remove all selected Results 4 Report Content Results listed with Assay Absorbance Concentration and Interpretation Selected under Report Settings Section 5 1 3 5 Retest add to Sample Tab Add the selected items to the sample tab to be retested 6 Export Export selected reports to a text file txt MS Excel file xIs or XML file xml Save for future reference Human gt Diagnostics Worldwide 37 138 Past results may be searched by selecting the checkbox next to History refer to Figure 4 3 5 1 Report Tab and Figure 4 3 5 3 Results of Search Using History Option Input as much search criteria as possible for more precise search results Management Routines Lot Registration QC Tracking Patient DB Settings Security Help E Erg TELE From g 3 30 2005 Name ID Blank IV History Search To Iv 3 30 2005 Test y q Request Time Name ID Test Absombanes Concentration Interpretation Note Reference Position Li Blank 7 3 30 2005 2 56 21 PM Albumin Pointe 0 281 Abs RKO 0 gt 401 2 3 30 2005 2 59 38 PM Albumin Pointe 1 527 Abs RKO 0 gt 405 31 1 3 30 2005 3 36 59 PM Albumin Pointe 0 430 Abs RKO 0 gt 402 2 3 30 2005 3 36 59 PM Example Calcium AZ III 0 000 Abs RKO 0 gt C01 32 7 3 30 2005 3 36 59 PM Example Direct Bilirubin 0 052 Abs RKO 0 gt 401 2 4 7 Select all Fold all Sort by Name ID y rr 2 Layout
11. Cancel Figure 6 6 6 Advanced Parameters Aspiration Speed The acceptable range is 0 to 4 where 4 is the fastest speed Default speed is 2 Air Gap Amount of air in microliters that will separate the substance being aspirated from the de ionized DiH20 water aspirated It separates prime bottle substance from the aspirated substance Default values are automatically selected based on the aspiration volume Pre warm Time Some tests require you to pre warm the standard after aspiration before it is added to the well The pre warm time can be set here Dispense Speed The acceptable range is 0 to 4 where 4 is the fastest speed Default speed is 2 Dispense Height There are two different levels of dispensing you can choose from High or Low 3 Arrow Buttons Select a Standard in the list to the left and click the arrow for the direction in which to move it in the list 4 Remove Select a Standard from the list on the left and click Remove to eliminate it from the list 5 Curve Valid Time x Valid Time E Dayle O0 Hours Cancel Figure 6 6 7 Curve Info Menu Set the amount of time in days hours or both that the Standard Curve should remain valid Default is 7 days Human gt Diagnostics Worldwide 105 138 6 7 Blank Bank AHAAQX_Yy _ N _ _ __ ___ W Blank Used Properties Figure 6 7 1 Blank Using a Blank is optional in all modes except Standard mode To use a Blank check
12. Figure 2 1 2 Install Prime Bottle 6 Using the serial cable provided connect the computer s serial port to the ELISYS UNO serial port reference Figure 2 1 3 Back of Instrument If necessary purchase a USB to serial converter available through other sources Power Cord i gt ii Reset Button Serial Port gt 5 2 rmn Tae Beebe py OES LN sitet g mae Ts 7 oe ere ee ri ee a t pa Figure 2 1 3 Back of Instrument 8 138 Human Elisys Uno User Manual Turn on the computer and insert the installation CD The installer should automatically start if not select Run from the Windows Start Menu run CD ROM drive setup and follow the prompts for installing the program Run the ELISYS UNO program after installation Enter Admin as the user ID and Admin as the password Reference Figures 2 1 4 through 2 1 9 below laa _inst32Lex_ 11 19 97 4 05 PM F_isdel exe 8KB Application 11 19 97 4 05 PM s _setup dll 11KB Application Extensi 11 19 97 4 08 PM 3_sys1 cab 183KB Cabinet 10 10 05 10 13 4M ES _userl cab 44KB Cabinet 10 10 05 10 13 4M 1KB TAG File 10 10 05 10 13 AM 6 770KB Cabinet 10 10 05 10 14 4M 5KB DAT File 5 30 97 11 31 4M 1KB BIN File 10 10 05 10 14 4M 1KB DAT File 5 6 97 2 15 PM 245KB Bitmap Image 8 12 05 9 22 AM 59KB Application 11 19 97 4 09 PM 1KB Configuration Setti 10 10 05 10 13 AM setup ins 57KB Internet Communic 10 10 05 10 13 AM laa setup lid 1KB LID File 10 10 05 10 14 4M
13. Normal Control NOTE To enter a target value and a range please register a lot number for this control in Chemwell manager Action to take when result is out of range Warn and Continue Y Valid Time 7 Dayls O Hours Cancel Advanced Figure 6 8 3 Control Properties Human Ex EEE _ E EE EEE EEE A gt A A gt Diagnostics Worldwide 107 138 Action to take when result is out of range o Warn and continue Continue the test when absorbance is out of the range but put a warning to the report o Invalidate tests Invalidate the assay results Valid Time Blank result valid time in days and hours Default value is 7 days Advanced Button Optional This should only be used if you need to set up different parameters than in the Add Sample Step Need Different Parameters than Add Sample Ste j NOTE Use this dialog only if you need to set different parameters than those set in Add Sample step Needs Different Volume pL Needs Different Advanced Parameters Advanced Parameters Cancel Figure 6 8 4 Need Different Parameters than Add Sample Step Needs Different Volume Check this box if the standard needs a volume that is different that the volume defined in the Add Sample Step When checked the Volume field is enabled Needs Different Advanced Parameters Optional Check this box if the standard needs advanced parameter s different than thos
14. R1 TSH Complete 0 291 Abs 1 4 plUtmL T R 2 TSH Complete 0 397 Abs 2 0 WUmL M R 3 TSH Complete 0 403 Abs 2 0 plUtmL T R 4 TSH Complete 0 307 Abs 1 4 plU mL Tas TSH Complete 0 542 Abs 2 9 plUtmL M A6 TSH Complete 0 204 Abs 0 8 plUtmL Ta TSH Complete 0 452 Abs 2 3 plU mL Tr 8 TSH Complete 0 798 Abs 46 plU mL T RY TSH Complete 0 389 Abs 1 9 plU mL M R 10 TSH Complete 0 495 Abs 2 6 ulU mL 9000000 29000006 29000090 29000000 090000000 00000000 9000000090 29000000 290090000 a i g 22 e z 41 a _ 999900000 F Select all Accept Delete View Schedule Resume All Le a Layout Bt Testis Report Figure 8 2 9 TSH Results The percent adjust feature can be used when stored curves are used and there is evidence that the current run has resulted in increased or decreased absorbance levels than what is expected NOTE Decreasing the standard curve by a percentage will result in increasing the sample concentration values Human D Diagnostics Worldwide 127 138 C Adjusting Curves by Running Less than All the Calibrator Values Less than all the calibrators used in an assay can be run and the stored curve can be adjusted accordingly The adjustment factor will be calculated based on the average percent change of all the new calibrators run compared to their stored absorbance values The new curve will be generated from the new calibrator s absorbance values which are currently run and the adjusted absorbance values of t
15. The sample handling system will be primed with deionised water The washer if applicable will be primed with wash solution and the lamps will turn on NOTE Observe the fluid handling system and ensure there are no leaks After running the Start of Day program visually check the sample handling tubing and the syringe for the presence of any bubbles If bubbles are present repeat the Start of Day program tapping the tubing where the bubbles are present If this does not eliminate the trapped bubbles perform the Weekly Alcohol Cleaning procedure found in Section 5 2 1 1 Human ss eee Diagnostics Worldwide 57 138 S211 Weekly Alcohol Cleaning Perform this procedure to purge the tubing of trapped air bubbles Weekly Alcohol Cleaning Replace the prime bottle with a bottle containing 70 Isopropyl Alcohol From the Routines Menu Select Prime Syringe Routines Lot Registra Start of Day End of Day Wash Probe Prime Syringes Prime washer Prime Rinse Temperature On Temperature OFF Filter voltages Read Wells Custom Script When the cycle is complete replace the bottle containing 70 Isopropyl Alcohol with the prime bottle containing fresh deionised water and repeat the Prime Syringe procedure 58 138 Human Elisys Uno User Manual 5 2 2 Sample Database Setup 5 2 2 1 Add Sample ID Add Sample ID 1 Select Sample DB from the menu M
16. approx weight 35kg Reagent and Sample Dispensing Capabilities Dilutions predilutions single or multiple reagents Pumps One syringe pump sized 2 5 ml Probe 316 stainless steel for maximum reagent compatibility level sensing Minimum and Maximum Volume 5 ul 1 95 ml Maximum number of specimens 96 including calibrators and controls Maximum number of reagents Typically 27 or 44 o Assorted replaceable racks and custom designed racks are available for various bottle sizes o Reagents can also be programmed to go to the Sample rack Reaction vessel Standard microwells strips Instrument bottles 1L Priming bottle 2L Wash bottle w low volume warning sensor 1L Rinse bottle or 2nd wash w low volume warning sensor Incubation timing and temperature control Thermal control Plate Well 25 C 37 C or ambient temperature o Temperature controlled to 25 C providing the ambient room temperature is below 25 C o Sample Rack is not temperature controlled Washing Wash Head 8 probe automatic prime and rinse Programs Create and run user programmable protocols aspirate dispense soak Can wash wells for re use as applicable Reading Reads absorbance in four simultaneous channels NIST traceable calibration user selects monochromatic or bichromatic results Optical design Light Source 4 position filter wheel Interference filters Linear range Photometric Accuracy 14 138 Human E
17. 100 250VAC 50 60Hz 160W Fluctuations not to exceed 10 of the nominal voltage Up to 2000 m 80 for temperatures up to 31 C decreasing linearly to 50 humidity at 40 C 5 C to 40 C See NOTE 18 35 C recommended Less than 85 recommended Human gt e Diagnostics Worldwide 15 138 16 138 Human Elisys Uno User Manual 4 ELISYS UNO Manager 4 1 Opening the Software and Security ELISYS UNO uses the standard Windows controls windows and dialogs Refer to your Windows documentation to become familiar with these controls and how to use them 4 1 1 Opening the ELISYS UNO Program Power on the instrument Double click on the ELISYS UNO icon to open the ELISYS UNO Manager software NOTE It is not necessary to turn the instrument off when restarting the software 4 1 2 Password Security and Logging In When either the ELISYS UNO Manager or Assay Editor software are opened for the first time a User name and a Password must be entered For User name type Admin For Password type Admin There are three security access levels Administrator Manager and Operator View Figure 4 1 2 1 for security levels Security Level Administrator Manager Operator Disable Security Y N N Enable Security Create Manager Create Operator Remove Manager Remove Operator Change Password View Log File lt lt lt lt lt lt lt Z2 lt lt 2 lt zZ22 Z lt 222 22 Figure 4 1 2 1 Security Levels Human gt ao D
18. 254 2688 j 2536 64135 387F 340 2 426 3 530 1 102 2 446 3 847 1 401 2 233 3 3557 1 124 2 533 3 644 1 111 630 5 035 6 459 1424 4382 5009 0 627 4299 6112 1813 600 6 126 7 306 1 178 5 378 5 726 0 348 5 233 6 999 1 7566 5 536 7 137 1 601 4 946 6512 1666 4342 5249 0907 4171 6 358 2187 505 4 854 6 901 2 047 4 310 5 602 1 292 4 087 6 688 2 601 4 422 6 6185 2 396 5 668 6 495 0 827 5 236 5588 0352 4800 6 309 1 509 405 4 568 6 228 1 660 4 396 6 061 1 665 3 976 6 058 2 082 4 495 6 400 1 905 The stored filter voltages data was saved at 111 7 04 7 56 26 4M Test Current Voltages Save Current Voltages Export Stored folkages Figure 4 2 3 2 Current Voltages Test Results All filter voltages should be between 2 00 and 10 00 reference Figure 4 2 3 2 Current Voltages Test Results Lower readings might indicate that a lamp is misaligned or partially blocked The data storage buttons on this window are for troubleshooting and are only used when instructed to do so by service engineers Click Close to exit If abnormally low voltage is detected the user will be prompted to mark the wells read by that lamp as unavailable If not able to immediately replace the lamp at that time allow the software to mark the wells as unavailable until it can be replaced 26 138 Human Elisys Uno User Manual 4 2 4 Channel Blanks Note Please see S
19. A constraining algorithm is applied to prevent curve overshoot 86 138 Human Elisys Uno User Manual Custom Formula Mode Assay Custom Formula Editor ELISYS UNO allows for custom formula to be entered Diagnostics Worldwide 87 138 6 3 Assay Steps Assay Steps Add Step Edit Step da Delete Sten Eopy Step El Figure 6 3 1 Assay Steps Dialogue Box An ELISYS UNO Assay is constructed of several successive steps They are Add Step Section 6 3 1 Edit Step Section 6 3 2 Order of the Various Steps Section 6 3 3 Delete Step Section 6 3 4 Copy Step Section 6 3 5 6 3 1 Select Step x Add Reagent Incubate Lag time Cancel Read Clean Probe Wash Wells Figure 6 3 1 1 Select Step Dialogue Box NOTE For advanced users Additional Parameters Advanced Button may be altered Otherwise default parameters will be used 88 138 Human Elisys Uno User Manual 6 3 1 1 Add Sample 4dd Sample Step Parameters i x Volume 2 0 pL Predilute Sample Cancel Advanced Figure 6 3 1 1 1 Add Sample Step Parameters Dialog 1 Enter the Sample volume to be added to a well 2 If predilution is needed enter the dilution ratio or manually enter the volume of Sample to volume of diluent being used When entering the dilution ratio the total predilution volume must be specified 3 If aclean rinse step between each pre dilution is needed choose the opti
20. ELISYS UNO reads and prints the monochromatic or bichromatic differential absorbance at the user selected wavelengths Blanking is optional Most Assays require a mode other than Absorbance Mode In this mode no calculations are made only absorbance values are reported y WE 5 7 KA n Assay Mode E Paint ta Point Axis T Y Abs X Conc Figure 6 2 3 Assay Definition Point to Point Mode ELISYS UNO accepts a number of calibrators and calculates concentrations based on the point to point calibration curve Calibrator materials of known concentrations are used to calibrate ELISYS UNO so that concentrations of unknown samples may be calculated The resulting calibrator curve is a series of lines connecting the calibrator points which may be entered in ascending or descending order of absorbance The direction of slope between the first and second calibrators determines the direction of the curve If the direction of the curve changes direction the curve will be flagged as being invalid and no interpretations will be printed Unknown samples are calculated as follows o The unknown sample s absorbance is read and compared to the absorbance of the calibrator o The line selected as the calibration curve used to determine the concentration of the unknown Sample is the line that connects the pair of Calibrators with absorbance values closest above and below the value of the unknown absorbance of the Sample o An unknown
21. ID or test name 36 138 Human Elisys Uno User Manual Management Routines Lot Registration OC Tracking Patient DB Settings Security Help 281 58800 4 44 O From Y 5 10 05 Name ID y l za T History Search To Y 5 10 05 Test y E Request Time Name ID Test Absorbance Concentration Interpretation Note F Kinetic trend abs vs sec E Example AST T 5 10 05 4 08 32 PM Normal Control 0 0076 d amp bs min 23 U L Failed Low T 5 10 05 4 08 32 PM Normal Control 0 0076 d bs min 23 U L Failed Low E 5 10 05 4 08 32 PM Abnormal Control 0 0550 d bs min T 5 10 05 4 08 32 PM Abnormal Control 0 0532 d bs min 160 U L Failed Low E Example Albumin T 5 10 05 4 08 32 PM Blank 0 055 Abs T 5 10 05 4 08 32 PM Chemistry Calibrator 0 406 Abs 3 5 g dL T 5 10 05 4 08 32 PM Chemistry Calibrator 0 403 Abs 3 5 g dL T 5 10 05 4 08 32 PM Normal Control 0 315 Abs 2 7 g dL Failed Low T 5 10 05 4 08 32 PM Normal Control 0 316 Abs 2 7 g dL Failed Low T 5 10 05 4 08 32 PM Abnormal Control 0 439 Abs 3 8 g dL Failed Low EW 7 5 10 05 4 08 32 PM Abnormal Control 0 452 Abs 3 9 g dL Failed Low 0 3060 30 130 180 L Example Glucose I 5 10 05 4 08 32 PM Blank 0 096 Abs RKO 0 gt 401 2 T 5 10 05 4 08 32 PM Chemistry Calibrator 0 390 Abs 210 8 mg dL 207 RK2 01 gt D01 3 T 5 10 05 4 08 32 PM Chemistry Calibrator 0 377 Abs 203 8 mg dL 207 AK2 01 gt 404 31 T 5 10 05 4 08 32 PM Normal Control 0 176 Abs 95 1 ma dL 99
22. Manager Toolbar Icons HA Elisys Uno EIA Mode Management Routines Lot Registration OC Tracki a et Be ae 1 2 3 4 5 6 7 8 9 10 1 Initialize 6 Communication Window 2 Pause or Resume Engine 7 Calibration Event 3 Pause or Resume Probe 8 Lot Registration 4 Reload Assay Files 9 QC Tracking 5 Switch Mode Not Available 10 Sample Database Human gt Diagnostics Worldwide 29 138 4 3 ELISYS UNO Manager Tabs 4 3 1 Layout Tab The default window which is open when the user starts the software is the Layout Tab y Elisys Uno EIA Mode a Management Routines Lot Registration QC Tracking Sample DB Settings Utilities Security Help 4 58 80H M4 0 Instrument Status 1 Loading Instruction Plate temperature 221C Waste bottle Empty Name ID Position Volume Probe temperature 26 6 C Wash bottle Full No items to show Temperature is changing to Room Temperature Rinse bottle Full All Rows 01 F Row o2 FP Row2 0000000003 FT Row3 090000000001 F Rows 0000000005 F Rows 0000000006 T Rows 0000000007 TF Row O08 F Rows 9 Rows O Row10 Row 11 Row12 Ou 005uU 007 00u O gt IE Figure 4 3 1 Layout Tab This window displays the current status of the instrument including the temperatures Also shown are the currently loaded racks and plate The software automatically keeps track of which wells in the reaction plate have been used Feature Description Item No Stat
23. Patient Report the Index is reported only if there was a valid test result for that patient for each of the Assays required to calculate the Index Assay Index Index Name New Index ElA Index Type Index Formula Editor Assays double click Operators Total IgE w A Toxo IgG Toxo IgM Treponema Pallidum TP TSH t Transglutaminase Ak U1 snRNP AB Cut off MEF Interpretation Settings C Normal Range C Positive Negative O Index Description Optional Figure 6 1 5 2 Create a New Index 80 138 Human Elisys Uno User Manual 6 1 6 Security SS Sth Security Help w Enabled Log in as different user Log out Create Mew User Remove User Change Password Who is logged in wiew Log File Figure 6 1 6 1 Security Menu Security allows the Administrator to designate other users as Operators or Managers The user s security level will decide what they are authorized to use Security Level Administrator Manager Operator Disable Security Y N N Enable Security Y N N Create Manager Y N N Create Operator Y Y N Remove Manager Y N N Remove Operator Y Y N Open Assay Y Y Y Save Assay Y Y N Open Panel Y Y Y Save Panel Y Y N Open Index Y Y Y Save Index Y Y N Create Substance Y Y N Edit Substance Y Y N Delete Substance Y Y N Figure 6 1 6 2 Security Access Table Enabled When Enabled is checked the password protection and security restrictions are being used Login as Different User Shows the Login scr
24. Sample with absorbance higher than the calibrator with the highest absorbance value is calculated using a line that passes through the two Calibrator points with the highest absorbance value An unknown Sample with absorbance lower than the lowest Calibrator absorbance is calculated from the line that passes through the two Calibrators with the lowest absorbance values Human J Diagnostics Worldwide 85 138 Regression Mode ELISYS UNO accepts a number of Calibrators and calculates concentration values based on a best fit curve linear regression Assay Mode Linear Regression 35 Axis Y Abs x Cone Ny Ln 1000 Abs Cone Y Abs s Ln Conc Figure 6 2 5 Regression Mode Data may be entered for linear linear In natural log linear linear In or In In calculations A logit log calculation is also available Absorbance or In of 1000 absorbance is always on the Y axis Concentration or In of concentration is always on the X axis pa Y ABS X CONC both the absorbance data y and the concentration data x are linear Y Ln 1000 ABS X Conc the natural log of the absorbance is plotted against the concentration The absorbance values are multiplied by 1000 before taking the logs Y ABS X Ln Conc absorbance is plotted against the natural log of the concentration 4 Y Ln 1000 ABS X Ln Conc the natural log of the absorbance is plotted
25. as you read this marking CAUTION CAUTION statements identify conditions or practices that could result in damage to this product or other property 2 138 Human Elisys Uno User Manual 1 3 Safety Precautions To assure operator safety and prolong the life of your instrument carefully follow all instructions outlined below Read Instructions Please take the time to read this manual carefully before using this instrument Review the following safety precautions to avoid injury and prevent damage to this instrument or any products connected to it To avoid potential hazards use this instrument only as specified For best results familiarise yourself with the instrument and its capabilities before attempting any clinical diagnostic tests Refer any questions to your instrument service provider Servicing There are no user serviceable parts inside the instrument Refer servicing to qualified service personnel Use only factory authorised parts Failure to do so may void the warranty Wear Protective Apparel Many diagnostic assays utilise materials that are potential biohazards Always wear protective apparel and eye protection while using this instrument Always operate this instrument with the aerosol shield lowered Follow Operating Instructions Do not use this instrument in a manner not specified by the manual or the protection provided by the instrument may be impaired Use Proper Power Cord Use only the power cord specified for this
26. based upon the concentrations 7 1 1 3 Dose Response Mode This mode uses nonlinear regression Levenberg Marquardt method to fit the calibration curve to a four parameter logistic equation defined by Y Bottom Top Bottom 1 10 LogEC50 X HillSlope This yields a sigmoid curve The parameter Bottom is the absorbance value at the bottom of the plateau Top is the absorbance value at the top of the plateau and LogEC50 is the concentration value halfway between the Bottom and Top The parameter HillSlope describes the steepness of the curve When the Hillslope is less than 1 0 the curve is shallower when the Hillslope is greater than 1 0 the curve is steeper 7 1 1 4 Polynomial Modes These modes use nonlinear regression to fit the calibration curve to polynomial equations The order of the polynomial equation tells you how many terms are in the equation Higher order equations have more inflection points Second order is defined by Y A B X C X 2 Third order is defined by Y A B X C X 2 D X 3 Forth order is defined by Y A B X C X 2 D X 3 E X 4 Assay Mode Assay Mode Assay Mode Polynomial 2nd order Polynomial drd order Y Polynomial 4th order Duz Asis Axis v 46s 4 Conc Y Abs Conc Y Abs X Conc La1000 4 bs Conc Y Lap 0008 b lt lt Conc Y Laf1000 8b Conc Y Abs Ln Conc Y Abs 4 Ln Conc Y Abs Lal Conc Y Laf1 DD
27. down window for menu items under Assay Human gt Diagnostics Worldwide 75 138 There are eight main parts to the Assay Editor E Assay Editor Assay View Substances Panels Indices Security Settings Help P His oan X Y EIA AS CtrIW Std Assay Name New Assa EIA Assay Mode Type El Version 1 Absorbance y D Temperature Room Temp ps V Flat bottom wells Assay Description Assay Steps Interpretation Settings TL Pane Normal Range C Positive Negative of Decimals 1 v Figure 6 2 Working Screen Item Section Location 1 Main Menu and Toolbar Section 6 1 2 Creating Assays Section 6 2 3 Assays Steps Section 6 3 4 Interpretation Settings Section 6 4 5 Special Groups Assay Editor Section 6 5 6 Standards Section 6 6 7 Blank Section 6 7 8 Controls Section 6 8 Controls Standards Curve Yalid Time Blank Blank Used Sample Run samples as doubles QC Criteria A a a HEME e E REEVE 76 138 Human Elisys Uno User Manual 6 1 Main Menu and Toolbar El Assay Editor Assay View Substances Panels Indices Security Settings Help Figure 6 1 1 Main Menu and Toolbar 6 1 1 Assay New ELISA Clears all entries and allows building of a new Assay Open ELISA Opens an existing Assay 6 1 2 View ay Substances f w Toolbar lg w Status Bar Figure 6 1 2 1 View Menu Toolbar Uncheck to close Status Bar Closed by default Human D D
28. eres 34 AS MESAS et sra o SAA eee ea 35 SAL oa a e o scsi etecsecteeececicciecieciccse seated ccc oeiecicc osc aidaiecacicdcceeeccuoeccucesseuseuaeeeeaoeaees 36 A Main et WUE CsI ie o 39 A IV A aan 39 AZ FOUE NE e oa 42 AS OE RE GISTN OM 43 A E T E 43 A SaMO DDA 44 A AAE E 44 A E Ad 44 7 7 St S m o 45 5 ROH ga SN E E ET 51 A a a e ee ee III 51 E O id 51 Bee o o Oo O o eo 52 Sa Sta OF DAV eer er tet eee eee eee rn 57 ye Fal e A 57 A A osas 59 5 2 3 O 65 Bs RUGMNE SANDIE Giaccone AAE EATA AA cescescescescescovensenscnycuseescoscoses cea cescescescescasco AANE AAAA 70 6 AS E E E 75 6 1 Main Menu and Toolbar Pi IS EOS EN e eds 77 A A S CO 77 O cA ee eee nn 77 e SSNS e MN e EEE N AA T AE E 78 O H T aE E 79 O INC E A 79 O a 81 OTS SENINE A ee 82 A A cccaeo create cs catoccscasa cscuenccscucucevec cucu sescacosescaco cscnco cscmto cscacaseseesseate 83 6 2 Creating ELISA ASSayS ue esesssssssecsssecessescsessssesussecusscsucsesucsecucscsussesusuecusuesussecussecussesucuesussesucuesucsesucsesucussucaesusaccucessucsesucucanenseneesees 84 TS Ty E E 0 AAA O 88 EAE E E E cece A E 88 C E E 96 A o Ee ULEO o A PO O E O 96 O E 0 E EA ee ert 97 o is A A SS II O N 97 64 MA O ae 98 So SOS Cla COU DS ASS IMEI 100 IS 103 O Py A 106 6 8 A een ee ee ee 107 7 Enzyme MUNAS ay FEON O iion nE OOOO OOOO OAE 113 Mi NGS EO a E S a E EEEE EE EEEE EEEE NTEE 113 7 1 1 ELISA SPECIES caia 114 7 2 ASSAY Select St
29. following the same protocol The protocol for data exchange is listed below Import Process o Select Management gt LIS Import o Choose a file containing LIS requests o Requested tests are added automatically to request list in the Sample tab Export Process o Inthe Report tab user will select records and press Export button o Inthe Save As Type drop down list the user will select LIS files lis User types in a filename and a folder for the file and presses Save button Record Definitions and Specifications Record Type Definitions H Indicates a Header Record primarily for informational purposes P Indicates a Patient Record and is patient specific information Indicates a Requested Assay to be run for the preceding patient Results from the Requested Assay preceding Indicates the End of the file Append this information to the preceding record may be used on any record Figure 4 4 1 2 Record Type Definitions A Carriage return is used to indicate the end of the line 220 is the maximum Record Layout Specifications Minimum Requirements 40 138 Human Elisys Uno User Manual Message A yop Append to the Previous J fJ J E Te E EIC NE A SAA Patient P Transmission Seq Patient ID Patient Name Sex Address Doctor Observation Order A Assay OBR Sequence Number Name ee ee HERA Aa EN acts ey CCT MS RS A Se a IN E E Nature of O
30. for this product with the grounding conductor of the power cord connected to earth ground Use only the fuse type and rating specified by the manufacturer for this instrument use of fuses with improper ratings may pose electrical and fire hazards To avoid fire or shock hazard observe all ratings and markings on the instrument Do not power the instrument in potentially explosive environment or at risk of fire Prior to cleaning and or maintaining the instrument switch off the instrument and remove the power cord For cleaning use only materials specified in this manual otherwise parts may become damaged It is recommended always to wear protective apparel and eye protection while using this instrument Respective warning symbols if appearing in this manual should be carefully considered Human gt Diagnostics Worldwide 5 DISPOSAL MANAGEMENT CONCEPT The currently valid local regulations governing disposal must be observed It is in the responsibility of the user to arrange proper disposal of the individual components All parts which may comprise potentially infectious materials have to be disinfected by suitable validated procedures autoclaving chemical treatment prior to disposal Applicable local regulations for disposal have to be carefully observed The Instruments and electronic accessories without batteries power packs etc must be disposed of according to the regulations for the disposal of electronic componen
31. in each assay If controls are not within their acceptable limits or if incomplete or non uniform washing is suspected disregard test results Since the ambient light may interfere with the optical sensors used to monitor mechanical movements always operate the instrument with the top cover down Do not operate the instrument if the probe is damaged or the pressure is unstable Do not operate the instrument if the wash head probes are damaged If the Waste bottle is overturned during operation set it upright When the run has finished check that the filter has not become wet and replace it if necessary If the hydrophobic filter becomes wet due to an overturned Waste bottle it will be blocked Continued use of the instrument with a blocked filter will impair washer effectiveness and may result in damage to the instrument Do not fill reagent bottles past the neck Doing so may cause the system to inadvertently aspirate air Do not fill Wash or Rinse bottles into the neck to prevent fluid from entering the pressure tube The Wash and Rinse bottles are pressurised during normal operation and the Waste bottle is under vacuum Do not remove bottle caps or tubing connections while the bottles are pressurised evacuated Turn the instrument off or click the Pause Engine in the Management menu before adding more solution changing bottles or connecting tubing The quality of washing often affects the validity of test results To assure adequate w
32. lot numbers for them is optional Lot Registration GX Management Routine Lota Registration QC Tracking SampleDB Settings Security Help Open Lot Registration from the top menu t OO Lot Registration fa Click the Substance in the left column Substance 0 5N NaOH you would like Specity standard s concentration for curve caculation specify range to monitor the quality optional 0 5N MaQH to register Lott 100 mg L Gallic Acid Std Nx 100ul PHP l 10ul PNP O E S Data For es 150 maL Gallic Acid Std 7 00 10 of 30 110 a o _ Cone Rana 50 mg L Gallic Acid Std 5ul PHP ul PHF 50 mg L Gallic Acid Std Click on 500 mo L Gallic Acid Std EDul PNP Register Sul PHP New Lot Abnormal Control Active LotH 334403 Anti HA Calibrator Anti HA Neg Control Active Lott 12 Anti HA Pos Control Anti HEc Heg Control Anti HEc Pos Control Anti HBe Neg Control AnttHBe Pos Control Anti HBs Neg Control Anti HBs Pos Control Ant HBs Pos Control 4nt NBe Pos Control Figure 5 2 3 1 Choose the corresponding name Enter Lot Substance Abnormal Control Lot E spiration Note M Cop data from current activated lott Figure 5 2 3 2 Enter Lot and optional description Enter the Lot and a description optional Click OK to Save a gt Diagnostics Worldwide 65 138 Concentration Range Lot Registration Specii standard s concentration for curve caculation pecite range to monitor the quality
33. optional Substance Lott 334403 5442005 Data For example vou can enter 5 as a standard s concentration enter 1 00 10 or 90 110 as a range Assay Abs Range AFP PSA CEA Conc Range Figure 5 2 3 3 Entering Concentration Range Specify standard s concentration for curve calculation specify range to monitor the quality optional Highlight the field to change type in new value Press the Close button to save 66 138 Human Elisys Uno User Manual New Curve and New Control In the Calibration tab add the New Curve and New Control to the Work List by selecting the corresponding option from the drop down menu In the above example refer to Figure 5 2 3 3 Entering Concentration Range ALL has been selected All programmed Calibrators and Controls will be added to the Work List You may run more than one of each of the calibrators In Figure 5 2 3 4 Select Curve we are only running one of each Change the numbers by using menu options Show backup FP Validity Add calibration test Work list Mame Figure 5 2 3 4 Select Curve Reps MI md Mi PAPI PhP Use drop down menu to change the number of copies A Select Curve from the drop down menu Press the New Curve button once for each blank and calibrator you intend to run Select Controls to add controls If you wish to save this as a Work List for validating your calibrators in the future press Save c
34. running is shown to the right of the drop down menus 3 Select All and Buttons Select All selects all patient ID s or patients may also be selected individually Check the box next to the ID s that you are choosing When at least one of the ID s is checked the row of buttons at the bottom is highlighted Click Accept to accept the results of the selected ID Rerun to run the selected ID again or Delete to discard the selected ID Choose Resume All to continue the tests Results must be accepted to allow you to view them in the Report tab 4 Legend Used by Software used to identify the processes and results being used Human gt e Diagnostics Worldwide 35 138 4 3 4 Report Tab Management Routines Lot Registration QC Tracking Sample DB Settings Security Help c BOA OD Name ID m Test Concentration Interpretation Absorbance Name ID Test I M 9 23 04 3 07 41 PM Creat r62 val 0 0009 d4bs 60sec 111 3 ma dL High Iv Creat r62 val 0 0003 d4 amp bs 60sec ls 8 eta 7 5 High High z Example ALT 0 0002 d bs min 1 Low Y Iv Creat r62 val 0 0004 d amp bs 60sec 5 0 mg dl High Iv Creat r62 val 0 0012 d amp bs 60sec f 15 0 moe 5 0 Low Low Iv Example ALT 0 0008 d amp bs min 2 UAL Low Iv R 3 M 9 23 05 3 07 41 PM Creat r62 val 0 0010 d bs b0sec 12 5 mg dl High M 9 23 05 3 07 41 PM Crea
35. the picture below a TSH standard curve is displayed This assay uses a 2nd order polynomial curve fit Moving the mouse pointer over the plotted curve will display the fit parameters v Add calibration test v Show backup Work list TSH Incomplete Abnormal Curve recent white current blue backup gray Control current pink Criteria CEE Absorbance Concentration Interpretation The curve based on selected records 4 15 2005 10 47 06 AM TSH Standard 1 0 011 Abs lt 0 0 Wum Out LR TSH Standard 1 0 010 Abs lt DO pl mL Dut LA I TSH Standard 2 0 246 Abs 0 7 pml E M TSHStandard2 0 244 Abs 0 7 pll mb No Data TSH Standard 3 0 455 Abs 3 0 plum M TSH Standard 3 0 463 Abs 3 1 HUM TSH Standard 4 0 854 Abs 2 4 pl mL Y A B X C X 2 I TSH Standard 4 0 868 Abs 7 5 pim A 0 185233 C TSH Standard5 0 134 Abs lt 0 0 pIUAmL Dut LR ez I TSH Standard 5 1 697 Abs 16 3 plUzmL Roan TOS TSH Standard 6 2 607 Abs gt 25 0 plU mL Dut LR M TSHStandad6 2563 Abs 25 0 plU mL jj gt Print Preview Print Report Factor joz Figure 8 2 1 Unedited Curve Layout l Calibration Clicking on the Test List tab will display the patient results sample shown below Highlight By Name ID y Highlight By Assay Current Step None Name ID Time Left Absorbance Concentration Interpretation Tra TSH Complete 0 291 Abs 1
36. 0 Next Assay Step EIAWASHWELL 00 36 27 GEE lt gt gt coosrnasrnl Y a Busy time block Incubation time block Mixing Close Figure 8 1 6 ELISA Work Schedule When Assays are complete the curve can be accepted refer to Figure 8 1 7 Statistics Patient concentrations will be calculated If controls are run in an Assay the Statistics can be displayed Select the Controls with the left mouse button and hold down the Ctrl key Absorbance MEAN 0 68 D 0 008 CV fizo DIFF Y Add calibration test i y Show backup Work list f oncentration 1 ACV 2320 DIFF pretation The curve based on selected records MEAN 2520 sD 0 084 TSH Standard 1 0 010 Abs lt 0 0 WUL TSH Standard 2 0 246 Abs 0 9 Wml l TSH Standard 2 0 244 Abs 0 8 plU mL No Data TSH Standard 3 0 455 Abs 2 4 pim i TSH Standard 3 0 463 Abs 2 5 pIU mL TSH Standard 4 0 854 Abs 5 6 plll me F TSH Standard 4 0 868 Abs 5 7 plU mL l TSH Standard 5 0 875 Abs 5 7 Wml TSH Standard 5 1 697 Abs 13 4 wlU mL TSH Standard 6 2 607 Abs gt 26 0 plU mL TSH Standard 6 2 563 Abs 24 8 plU mL MEA Level 1 Control Level 1 Control Level 1 Control Level 1 Control Level 1 Control Absorbance ian o Figure 8 1 7 Statistics 122 138 Human Elisys Uno User Manual 8 2 Accepting and Adjusting Standard Curves A Deleting Calibrators In
37. 0 ABS lt LafConc Y Ln 1000 4B 5 Ln Lonc Y Ln 10004B 5 Lo Lonc ABS L BS L ABS s L 114 138 Human Elisys Uno User Manual 7 2 Assay Select Steps Refer to Section 6 Assay Manager 1 Add Sample 2 Add Reagent 3 Incubate Lag time 4 Read 5 Rinse Probe 6 Wash Wells Wash Step Parameters xj How many times bo wash 4 z Wash Volume 00 a pL Soak Time 10 a SEC Cancel Figure 7 2 1 Wash Wells Step Parameters Human gt Diagnostics Worldwide 115 138 7 3 OC Criteria In New Assay ELISA the QC Criteria button will display as shown in Figure 7 3 1 NOTE There must be substances standards controls blank in the assay before selecting QC Criteria Clicking the OC button brings up the OC Criteria window shown in Figure 7 3 1 From this window one can add new control criteria delete edit or change the checked order of the control criteria defined in the Assay Assay Editor New Assay ELA Cut Off Standard oom Temp Point to Point Linear Regression Cubic Spline Constrained Dose Response Folnomial 2nd order H Polunomial 3rd order HOL LOL Calibrator m Figure 7 3 1 OC Criteria 116 138 Human Elisys Uno User Manual Pressing the OC Criteria button will open the OC Criteria window QC Criteria Correction invalidate Delete Al Delete Er EN Edit Close Options to delete all delete scroll using arrow keys and edit ass
38. 00 90000000 90000000 90000000 900000000 900000000 ulu Figure 8 2 5 Accept Results B Adjusting Curves by a Percentage Factor Curves can also be adjusted by a percentage factor This is set by the factor setting in the calibration tab Normally this value is set to 0 and the actual standard curve absorbance values are used with no adjustment TSH Incomplete Abnormal Y Add calibration test l Curve recent white current blue backup gray Control current pink Criteria Show backup Work list Absorbance Concentration Interpretation The curve based on selected records lt 00 plm Dut LA I QUA oO o o oO Absorbance 2222 i O oO DuLA Figure 8 2 6 TSH Curve 0 Factor The resulting concentration values for the samples run are shown below in Figure 8 2 7 TSH Results Human gt a Diagnostics Worldwide 125 138 Name ID Time Left Highlight By Name ID y Highlight By Assay 7 Current Step None Absorbance Concentration d q A Interpretation TSH TSH TSH TSH TSH TSH TSH TSH TSH TSH ACACIA IA Spd a bras brag ted Eva ep e es 10 0 J M0 MH uN o l Select all Accept a View Schedule Complete Complete Complete Complete Complete Complete Complete Complete Complete Complete 0 291 Abs 0 397 Abs 0 403 Abs 0 307 Abs 0 542 Abs 0 204 Abs 0 452 Abs 0 798 Ab
39. 0600 4 9450 3 9430 3 8820 4 5640 3 7770 Channel4 3 3410 3 9350 5 9220 7 2910 6 0770 61160 7 6280 6 6630 Type Wel Chn Readings 405 630 Mean SD CY Blank 401 2 0 0002 0 0024 0 0019 0 0012 0 0012 0 0014 0 0008 D01 3 0 0011 0 0001 0 0004 0 0002 0 0004 0 0000 0 0006 404 1 0 0004 0 0010 0 0011 0 0020 0 0020 0 0011 0 0010 D04 4 0 0006 0 0012 0 0010 0 0007 0 0017 0 0010 0 0004 Small B01 2 0 2926 0 2924 0 2930 0 2927 0 2940 0 2929 0 0006 0 2154 2 0 2900 0 2899 0 2905 0 2897 0 2897 0 2900 0 0003 0 1133 E01 3 0 2949 0 2954 0 2951 0 2956 0 2951 0 2952 0 0003 0 0940 FO1 3 0 2885 0 2882 0 2876 0 2886 0 2885 0 2883 0 0004 0 1418 B04 1 0 2961 0 2957 0 2954 0 2962 0 2947 0 2956 0 0006 0 2049 CO4 1 0 2891 0 2881 0 2884 0 2896 0 2891 0 2889 0 0006 0 2086 E04 4 F04 4 0 2944 0 2940 0 2950 0 2945 0 2964 0 2949 0 0009 0 3160 0 2886 0 2885 0 2892 0 2886 0 2889 0 2888 0 0003 0 0998 Medium 402 2 1 3439 1 3449 1 3447 1 3450 1 3432 1 3443 0 0008 0 0573 i BO2 2 1 3401 1 3411 1 3411 1 3400 1 3427 1 3410 0 0011 0 0810 Self Test Failure Checklist Self Test failure is defined as follows Type CV Criteria Large 18ul sample gt 2 Medium 10pl sample gt 2 Small 2ul sample gt 3 Please note e Verify start and ending temperatures are room temperature e All blanks should be between 0 005 and 0 005 If not repeat setting blanks e Filter Voltages must be between 2 and 10 e Make sure the plate positio
40. 2 07 19 pa Busy time block Incubation time block Mixing Figure 8 1 2 Work Scheduler 4 After reviewing the work schedule click on OK The Wash bottle selection window Figure 8 1 3 Select Bottle will be displayed Select whether the Assays will use the Wash or the Rinse bottle for the plate washing steps Click the OK button te ee att Select Bottle Please select the bottle used in wash step for each assay Bottle Used In wash Step Wash Bottle Wash Bottle Wash Bottle Wash Bottle Assay E h fa Figure 8 1 3 Select Wash Bottle 5 Place all the needed reagents and samples into the correct rack locations place the proper coated ELISA strips into a plastic strip tray and click All are Loaded The Assay processing will begin The time remaining for completion of each Calibrator Standard Control and Sample is displayed on the screen refer to Figure 8 1 4 Test List 120 138 Human Elisys Uno User Manual Highlight By Name ID y Highlight By Assay 7 Current Step Wait Name ID T T3 Standard 1 3 M T3 Standard 1 T3 TimeLeft Absorbance Concentration Interpretation A M T3 Standard 2 T3 lt 66 min TF T3 Standard 2 T3 lt 66 min M T3 Standard 3 T3 lt 66 min M T3 Standard 3 T3 lt 66 min T3 Standard 4 T3 lt 66 min T3 Standard 4 T3 lt 66
41. 2 wWlU mL TP R 2 TSH Complete 0 397 Abs 2 4 pU mL M R 3 TSH Complete 0 403 Abs 2 4 plU mL T R 4 TSH Complete 0 307 Abs 1 4 WUL Tas TSH Complete 0 542 Abs 40 plU mL Tas TSH Complete 0 204 Abs 0 2 WUL Low Ta TSH Complete 0 452 Abs 3 0 plU mL M R 8 TSH Complete 0 798 Abs 6 8 Uml High 009004000 T R9 TSH Complete 0 389 Abs 2 3 wWlU mL E E R 10 TSH Complete 0 495 Abs 3 5 WU tm 00000000 2000090000 90000900000 90090090000 29000000 29000000 29000000 90000000 29000000 9000000 20000006 29009000 29000000 29000000 29000000 299000000 29000000 29000000 lt y 33933033 I ees 9000000009 Select all View Schedule Layout yo Calibration 2 Sample ib TestList Report Figure 8 2 2 Un edited results This data shows that the first copy of standard 5 appears incorrect By checking the boxes to the left of each standard a corrected curve can be generated Once a satisfactory curve is generated clicking on the Activate Selected button will cause this curve to be the current standard curve in use and will update the concentration values of the samples in the Sample Tab The corrected curve is shown below in Figure 8 2 3 TSH Results Edited The patient sample results are now updated which you can see by clicking on the Test List tab Human D Diagnostics Worldwide 123 138 TSH Incomplete Abnormal Y 7 A BEX C X 2 Curve recent white current blue backup qray Control current pink Criteria ist
42. Calibration Sample Figure 4 3 5 3 Results of Search Using History Option 1 Search by Date Use the drop down menus to select the dates to search for results 2 By Name ID Search for results for a specific Patient 3 By Assay Use this menu to search for results from a specific assay 4 Buttons These work the same way as described in previous section Note If needed an Assay Report or a Calibration Report may be printed from the Calibration window See Section 4 3 2 Calibration Tab for more information 38 138 Human Elisys Uno User Manual 4 4 Main Menu Selections and Features Management Routines Lot Registration GC Tracking Sample DB Settings Security Help This section will introduce you to the items located in the ELISYS UNO Manager s main menu 4 4 1 Management Menu OPTION Initialize Pause Engine Reload Assay Files Switch Mode Change Temperature Change Rack1 Auto Wash Plate Multi Plate Test Communication Window Calibration Event LIS Import Exit nm Elisys Uno EIA Mode Routines Lot Registratia Initialize Pause Engine Ctrl F 1 Reload Assay Files Switch to Chemistry Mode Change Temperature Change Rack Multi plate Test Communication Window FS Calibration Event F8 LIS Import Exit Figure 4 4 1 1 Management Menu Options DESCRIPTION Establish or re establish communication between the software and the instrument without restarting the s
43. Custom Report ri co o aoo Probe vs Wash Cup Washer vs Plate Rack Dispense Height Channel Blank Display Instrument Parameters Restore Instrument Parameters Human gt Diagnostics Worldwide 23 138 Alignment Continued Insert a plate or strip tray when ted Click th be button prompted Click the probe button a The plate will move under the wash head and the wash head will asher vs Plate xj lower into the wells The plate and wash head should be positioned so that the aspiration needles are centred left to right toward the back of the wells touching but not pressing on the bottoms of the wells Use the arrows to position the wash head correctly a Please Wait es When finished click Test to check new alignment If aligned click Save then Close 24 138 Human Elisys Uno User Manual 4 2 2 Rack2 Dispense Height Used to select the dispense height when dispensing to a sample rack for pre dilution purposes reference Figure 4 2 2 1 Adjust Probe Dispense Height select the Low dispense height the up and down arrows will adjust the probe up and down the button will move the probe to its actual position setting Low is normally used for dispensing small volumes such as serum to a predilution High is normally used for dispensing a large volume of diluent these settings are specified when programming the assay in Assay Editor Low should be s
44. E Air Gap 2 Dispense Speed 2 E Dispense Height Low d a Cancel Figure 6 3 1 1 4 Advanced Parameters Click the Advanced button Optional Feature Description Item No Aspiration The acceptable range is 0 to 4 where 4 is the fastest speed 1 Speed Default speed is 2 Slower speeds result in better precision but decreased throughput Air Gap Amount of air in micro litres that will separate the substance 2 aspirated from the de ionized DiH20 water in the system Default values are automatically selected based on the aspiration volume Dispense Speed The acceptable range is 0 to 4 where 4 is the fastest speed 3 Default speed is 2 Slower speeds result in better precision but decreased throughput Dispense There are two levels of dispensing High or Low The default is 4 Height Low for a Sample and High for a Reagent 90 138 Human Elisys Uno User Manual A MAIN SETTINGS Dilution Ratio Ratio of sample volume to total volume Total Volume Total predilution volume Sample Volume Sample volume to be added to the diluent to make the dilution Advanced Button optional Opens the advanced parameter dialog where the Aspiration Speed and Air Gap can be changed Dilute to Plate instead of sample rack Check this option if you want the dilution to be sent directly to the well Set the Volumes Manually Manually specify the volume of Sample and diluent to be used for the predilution
45. E Row 4 Instructions Row 5 Row 6 to load the Row Rows Rows F Row 10 FP Row FP Row 12 racks When all are correctly loaded press the All are Loaded button NOTE Use the drag and drop feature to change reagent or sample locations within their rack location and between racks as well Human gt ms Diagnostics Worldwide 71 138 The Test List tab opens as shown in Figure 5 3 4 Test List Tab Opens After the tests are complete you must Accept Delete or Rerun the tests Tests must be accepted before they can be viewed in the Report tab Click the Report tab to get reports on all of the results refer to Section 4 3 5 Report tab Management Routines Lot Registration QC Tracking Sample DB Settings Security Help 8453 80 4 400 Highlight By Name ID Highlight By Assay y Current Step None En Time Left ERES 122456573 90000000s 00000000000 00000000000 O T Select all 2a rr ese AT Legend used by software 5 TEHTE E Cain qa renta E Figure 5 3 4 Test List Tab Opens Layout 5 4 End of Day At the end of the day place deionised water in the Rinse bottle if it does not already contain it Place a bottle of approximately 30 chlorine bleach chlorine bleach 5 25 Sodium Hypochlorite in Rack1 Position1 Select End of Day from the Routines menu and follow the prompts This will completely bleach the sample handl
46. EIAWASHWELL lt Layout WASHPRB ASP DISP WASHPRB_GRP ASP_GRP DISP_GRP WAIT WASHPRB_GRP ASP_GRP DISP_GRP WASHPRB_GRP ASP_GRP WASHPRB_GRP WAIT WASH_ASP WASH_DISP WAIT WASH_ASP WASH_DISP WAIT WASH_ASP Skip 0 AirBag 11 14 02 07 Skip 0 Name T3 Standard 1 Vol 60 0 AirPlug 0 14 02 08 Skip 0 Name T3 Standard 1 Vol 50 0 DispHigh C 14 02 09 Skip 0 AirBag 25 14 02 50 Skip 0 Name T 3 Antibody Reagent Vol 60 0 AirP 14 02 51 Skip 0 Name T3 Antibody Reagent Vol 50 0 Disp 14 02 53 Seconds 20 Skip 0 AirBag 25 14 02 55 14 03 18 Skip 0 Name T3 Working Conjugate Yol 120 0 A 14 03 19 Skip 0 Name T3 Working Conjugate Yol 100 0 D 14 03 20 Skip 0 AirBag 50 Skip 0 Name 1N HCI Vol 500 0 AirPlug 0 Skip 0 AirBag 1 Seconds 3600 Seconds 1 Seconds 1 Calibration 2 Sample ist 14 03 26 14 03 27 14 03 28 14 03 22 Test List Figure 8 1 5 Step Log 14 02 12 14 02 11 14 02 11 14 02 55 14 02 54 14 02 55 14 03 15 14 03 23 14 03 22 14 03 22 14 03 31 14 03 30 14 03 33 00 51 59 Report Human A Diagnostics Worldwide 121 138 Check the Assay processing status by clicking on View Schedule button This will display an approximated time line of the Assay processing refer to Figure 8 1 6 ELISA Work Schedule EIA Work Schedule The schedule performed by current work which is being updated theoretically while time passing 00 30 00 01 00 00 01 30 0
47. ELISYS UNO User Manual Elis CE Cat No 17350 1 No 01 02 03 Rev DATE 01 2006 06 02 2008 02 03 2009 05 REVISION LIST OF THE MANUAL REVISION DESCRIPTION First edition Adaptation to new corporate design Performance check kit added NOTICE Analytical instruments for in vitro diagnostic application involve the handling of human samples and controls which should be considered at least potentially infectious Therefore every part and accessory of the respective instrument which may have come into contact with such samples must equally be considered as potentially infectious BIOHAZARD The BIOHAZARD warning label must be affixed to instrument prior to first use with biological material Servicing Note Before doing any servicing on the instrument it is very important to thoroughly disinfect all possibly contaminated parts Before the instrument is removed from the laboratory for disposal or servicing it must be decontaminated Decontamination should be performed by authorised well trained personnel only observing all necessary safety precautions Instruments to be returned have to be accompanied by a decontamination certificate completed by the responsible laboratory manager If a decontamination certificate is not supplied the returning laboratory will be responsible for charges resulting from non acceptance of the instrument by the servicing centre or from authority s interventions HU
48. Ge Ele Edt Search Help 12 Eample ID Family Hame Given Hame Middle Hame Sex Po DE 12 122 Smith Jane F Diabeti o Se abetic 2 Click on File and select Save Close the window when finished Human gt ms Diagnostics Worldwide 63 138 5 2 2 7 Search Patient Record Search Patient Record 1 Enter criteria into Search Database area press OK All records containing the specified criteria will display l Sample Database Search database T 0 T aE g Sample ID Familt Name Given Name Middle Name Sex DOB Address Doctor Keyword Custom Pine RUE ERNE MME E REE RENE MERE REE MON E MRE E E BERNE REE E Pr r rere peepee eet tee E p eee ao lr do Gries Ee ad pes he oh SPS SME OAS SAS SHS AS SAS SAS SH OAS SH OA OS rot E EE EEk Aer HEERST ETHERS EE EEEE PEE EERE ieee eae ete eae eae eco EEEE IEEE enn mn ia Search result displayed 5 2 2 8 Choose Patient Record Choose Patient Record 1 Select the Choose button to add a selected patient to the Sample ID list in the Sample tab i Elisys Uno EIA Mode Management Routines Lot Regist rice Be Enter sample IDs Choose ID Total 1 64 138 Human Elisys Uno User Manual 5 2 3 Calibrators Before Samples can be read Calibrators must be registered and read Open the Calibration Tab and choose Example Albumin from the Choose Assay drop down menu NOTE For ELISAs calibrator standard values are set in the Assay Editor and entering
49. MAN Gesellschaft f r Biochemica und Diagnostica mbH Max Planck Ring 21 65205 Wiesbaden Germany Tel 49 61 22 99 88 0 Fax 49 61 22 99 88 100 e Mail human human de www human de Human ss A Diagnostics Worldwide a 1 INTRODUCTION This manual is considered as a part of the instrument it has to be at the operator s hand as well as at the maintenance operator s availability For accurate installation use and maintenance please read the following instructions carefully In order to avoid instrument or personal damages carefully read the GENERAL SAFETY WARNINGS describing the suitable operating procedures In case of breakdowns or any troubles with the instrument apply to the local Technical Service 2 USER WARRANTY HUMAN warrants that instruments sold by one of its authorised representatives shall be free of any defect in material or workmanship provided that this warranty shall apply only to defects which become apparent within one year from the date of delivery of the new instrument to the purchaser The HUMAN representative shall replace or repair any defective item at no charge except for transportation expenses to the point of repair This warranty excludes the HUMAN representative from liability to replace any item considered as expendable in the course of normal usage e g lamps valves syringes glassware fuses diskettes tubing etc The HUMAN representative shall be relieved of any liability under
50. No Curve A 8 2 Microglob in MixFix Total f A B 2 Microg4bulin MixFix No Curve A B 2 Micyfalobulin MixFi A 8 2 eroglobulin MisFi No Curve Close A B Microalobulin NoDi No Curve 2 Microglobulin testw No Curve Incomplete BYDY Unitech Invalidated Abnormal Expired A BYDY Unitech No Curve Invalidated Incomplete A CMY IgG DiaSorin No Curve Incomplete A CRP Incomplete Expired A CRP BioCheck No Curve Incomplete A CRP BioCheck MixFix No Curve Incomplete _ A CRP BioCheck _ No Curve Incomplete Add Sample ID A CRP dilutiontest No Curve Incomplete 3 Remove Add Select all T Export it equ Figure 4 3 3 1 Sample Tab This tab can be used to set up a quick and easy work list NOTE The drag and drop feature allows reagents and sample racks to be changed within their rack location and between racks as well 1 Enter Sample IDs Press the Add Numerical ID button to enter samples by number After pressing the button follow the instructions in the pop up Press Add Patient ID to choose a patient from the Patient Database Reference Section 5 2 3 Patient Database Setup for more information 2 Choose Tests Click on one or more of the patient ID s on the left With the patient s highlighted choose the assay or assays to run with the chosen patients Click on the test and press Add test Click on the same test again to d
51. Reagent bottles and sample tubes are placed into the removable instrument racks The instrument is programmed to pick up from one place dispense to another wash the probe read the wells incubate mix etc 1 1 Intended Use FOR IN VITRO DIAGNOSTIC USE This instrument is designed for use in processing ELISA tests for in vitro diagnostic application It is an instrument intended to be used by trained laboratory professionals who are capable of selecting the appropriate features and options for each specific clinical application Human gt ae Diagnostics Worldwide 1 138 1 2 Warning Markings 1 2 1 Safety Symbols Symbols that may appear on the product ADA WARNING Protective Ground CAUTION BIOHAZARD Risk of Shock Earth Terminal Refer To Manual Risk of Infection I f FUSE For continued protection against risk of fire replace with fuse only with one of the specified type and current ratings Disconnect equipment from supply before replacing fuse These terms may appear on the product DANGER indicates an injury immediately accessible as you read this marking WARNING indicates an injury hazard not immediately accessible as you read this marking CAUTION indicates a hazard to property including the product These terms may appear in this manual WARNING WARNING statements identify conditions or practices that could result in injury or loss of life WARNING indicates an injury hazard not immediately accessible
52. S Standard TSH Standard 1 TSH Standard 2 TSH Standard 3 MA TEH Standard 4 TSH Standard 5 TSH Standard lx Felt Or Figure 6 1 3 4 Manage Standards 6 1 4 Panels This feature allows you to set up and save panels of assays to be run as a group Use the Add and Remove buttons to edit the Panel Assays list Assays can belong to more than one panel bstances Indices Security New EIA Open EIA gt y Assay ELA iw el Version 1 f Ta OO Figure 6 1 4 1 Panel Menu Sy PanelsEla qe E Cancel ZA Figure 6 1 4 2 Select an Existing or Newly Created Panel 6 1 5 Indices Sometimes a test result is not a measurement but a calculation made from other measurements To create an equation that calculates a test result select New ELISA Human gt Diagnostics Worldwide 79 138 Refer to Figure 6 1 5 2 Create a New Index that follows 1 Index Name Give the New Index a name 2 Assays Click an Assay twice to add it to the Index Formula Editor 7 3 Operators Click once to insert into the equation 4 Numbers Click to add numbers to the equation 5 Backspace Click to remove last action 6 Interpretation Settings See Section 6 4 for more information 7 Index Formula Editor Displays the equation you built Be sure the formula is correct before saving 8 Index Description Optional Type a description of your Index When making a
53. Test List tab shows the status of the current run When ELISYS UNO is finished reading the Calibration Event window opens This window shows whether the new curves and controls were accepted If the curve is not accepted this procedure must be repeated 68 138 Human Elisys Uno User Manual The controls will be accepted even if they read out of range if the Control Properties are set to Warn and Continue To check your Control Properties or change this setting see Section 6 7 in Assay Editor If you do not want to see this window every time click the Do not automatically show up box in the bottom left corner of the window refer to Figure 5 2 3 7 Calibration Event If checked the Calibration Event can only be viewed by selecting it from the Routines window or by pressing the F8 key on your keyboard at any time Calibration Event Calibration event list double click to go to calibration tab to check detail Name Event Status Time Performance Check Control Activated 5 10 05 12 48 31 PM Performance Check Status Example 45T Control Activated 5 10 05 4 16 40 PM Example AST Status Abnormal Example LDH Control Activated 5 10 05 4 18 20 PM Example LDH Status Example Albumin Curve Activated 5 10 05 4 18 23 PM Example Albumin Control Activated 5 10 05 4 18 23 PM Example Albumin Status Abnormal Example Glucose Curve Activated 5 10 05 4 20 45 PM Example Glucose Control Activated 5 10 05 4 20 45 PM E
54. U C 0 00382888 R2 coef 0 99571 Mo MT MI Vv Ka WT VT E V TS MT eS i ed Activate Selected TSH Incomplete Abnormal v Add calibration test y Curve recent white current blue backup gray Control current pink Criteria Show backup Work list The curve based on selected records No Data AAA AAA Request Save Activate Selected Disoatd Recent Print Preview Print Report Factor jox Load Remove Figure 8 2 4 TSH ma Activated You can now choose to accept or delete any of the sample results by clicking on the buttons In Figure 8 2 5 Accepted Results all Samples are selected 124 138 Human Elisys Uno User Manual Highlight By Name ID y Highlight By Assay y Current Step None Name ID Time Left Absorbance Concentration Interpretation lv R1 TSH Complete 0 291 Abs 1 2 pl mL Iv R 2 TSH Complete 0 397 Abs 1 8 plUtmL Iv R 3 TSH Complete 0 403 Abs 1 8 plU mL IV R 4 TSH Complete 0 307 Abs 1 3 plU me Vas TSH Complete 0 542 Abs 2 6 WUmL MV R 6 TSH Complete 0 204 Abs 0 7 plU mL Iv R 7 TSH Complete 0 452 Abs 2 1 plUmL Iv R 8 TSH Complete 0 798 Abs 41 plU mL lv R 9 TSH Complete 0 389 Abs 1 7 plUtmL M R 10 TSH Complete 0 495 Abs 2 3 wWU mL lt Mil M Select all Accept Delete View Schedule Resume All 969000000 900900090 9000009000 90000000 9000000009 900000000 900000
55. against the natural log of the concentration 5 Select Y Logit Abs X Log Conc to calculate unknowns using the equation Abs Logit Ln sample 0 cal 1 sample 0 cal N W When using the Logit calculation the O calibrator is not plotted as part of the curve it is used only for the calculations In the Linear Regression mode resulting concentrations will be the same no matter what base is used In or log However slopes and intercepts will vary When using a format which calculates the In of the concentration do not use 0 0 for the concentration since In O is not defined If a 0 0 concentration Calibrator is used it will be ignored when the regression is calculated Note that in the logarithmic modes any values which require the log of a zero or negative number are invalid and will either invalidate the curve if in the Calibrators or invalidate the specimen Likewise when using In of 1000 Abs the absorbance values must be nonzero and positive Cubic Spline Constrained Mode ELISYS UNO accepts a number of Calibrators and calculates concentrations based on the Cubic Spline Constrained calibration curve Calibrator materials of known concentrations are used to calibrate ELISYS UNO so that concentrations of unknown Samples are calculated from the generated curve The resulting calibrator curve is a smooth curve connecting the Calibrator points which may be entered in ascending or descending order of absorbance
56. ally assigned at run time 102 138 Human Elisys Uno User Manual 6 6 Standards Standards are used to create the curve for calculating concentration from absorbance Standards are available in all calculation modes except Absorbance and Factor Assay editor has one standard predefined called Standard Standards Eure valid Jime Figure 6 6 1 Add Standards G Add Button 2 Properties Properties t al Ca Arrow Keys Remove 4 Remove Remove All Curve Valid Time NOTE The Add button is disabled when the chosen assay mode does not use a Standard It also becomes disabled when the maximum number of Standards for a selected mode has been added to the assay 1 Add Select an existing Standard or create a new one Select a Standard or define a new one E Toxo IgM Neg Cntr ES Toxo IgM Pos Ctr E Transglutam IgA 1 ES Transglutam lg 2 E Transglutam IgA 53 E Transglutam Ig 54 E Transglutam Ig 55 MA SH Calibrator 4 TSH Calibrator B _ TSH Calibrator C TSH Calibrator D EE TSH Calibrator E MA TSH Calibrator F tT3 Calibrator 4 2 tT3 Calibrator B tT3 Calibrator C E T3 Calibrator D E T3 Calibrator E MT 3 Calibrate F Figure 6 6 2 Select or Create a Standard M Standards SH TSH Calibrator 4 0 0 o Ste TSH Calibrator B 0 5 St TSH Calibrator E 3 0 St TSH Calibrator D 6 0 55 TSH Calibrator E 15 0 ES SG TSH Calibrator F 30 0 Curve Valid Time Figure 6 6 3 Standard Selected
57. anagement Routines Lote Registration QC Tracking Sample DB Settings Security Help 2 When first opened the Sample Database window will not have any records to display Sample Database Search database lr E A on 20 Sample 1D Family Name __ Given Name _ Middle Name Sex DOB Address Doctor Keyword Custom 3 Select the Edit button to enter Sample ID Family Name Given Name etc This will be helpful as search criteria when searching the database Press the Done button when finished NOTE The Edit button toggles to Done 4 An instructional dialog box will open Navigate through the fields on the screen by using the Tab or arrow keys on the keyboard Create a Sample ID by typing in the Sample ID field Modify a Sample ID record by clicking on the field to edit and typing Delete a Sample ID by highlighting the record to delete and press the Delete key on the keyboard Elisys Uno Mavigate press Tab or arrow keys Create type in the last Sample ID Field Modify type in other white fields Delete select a Sample ID and press Delete key Diagnostics Worldwide 59 138 Add Sample ID Continued Additional criterion includes Keyword or Custom Information that can be useful in either Keyword or Custom can include but is not limited to medical issuer study ID numbers or
58. ashing follow these precautions Perform End of Day to clean probe with bleach and flush wash head with H20 Handle and store the wash head carefully to prevent damage Use the prime cycle before each wash Human gt as Diagnostics Worldwide 5 138 Notes 6 138 Human Elisys Uno User Manual 2 Installation How to unpack set up and check out your ELISYS UNO instrument ELISYS UNO is carefully packaged in a custom made container to assure its safe arrival If upon receipt the outer packaging is damaged report damage to your freight carrier immediately When shipping it is important that the instrument be anchored and packaged in the original manner to prevent shipping damage Therefore retain all shipping screws and packaging in the event the instrument requires future relocation The details how to unpack the instrument once it is removed from its crate can be found in the Unpacking Instructions Manual Cat No 17350 4 2 1 Instrument Setup 1 Connect the drain tube to the drain tube connector on the bottom of the instrument by pushing the tubing over the fitting on the connector 2 Place the other end of the drain tube into a drain container at least 2L not included Next the bottle must be placed at a level below the instrument either by using an access hole on the lab bench or by routing the tubing to the front or the back of the instrument as desired The drain line may also be connected to an approved
59. ay criteria are presented Pressing the New button brings up QC Criteria Templates window This window contains most of the OC equation types that are typically needed for validating cut off ELISAs Choose the equation template that matches your equation and then assign the substance s variable s and operator used in the equation You can also set correction options such as dropping the worst value and recalculating or allowing a set number of controls to be cut QC criteria templates 3 xX ABS Blank lt 1 000 Formula Parameters Criterion type ABS S lt gt 4 n 5 lt gt x A ABS 5 lt Y A lt Mean 5 lt Y A Mean 5 lt 4B5 5 lt Y Mean 5 IFABS 5 lt gt amp THEN ABS S 1 IF Meand S lt gt lt THEN Mean 5 Y A ABS LS lt 4B5 5 lt 1 ABS AS A ABS LS lt Mean 5 lt ABS AS 5 Substance General Formula Substance Blank Operator c 5 es 1 000 Correction Mo Correction Y Cancel Figure 7 3 2 OC Criteria Templates Human gt Diagnostics Worldwide 117 138 If no suitable template exists for the required equation define a custom equation by clicking on the General Formula button This brings up the window shown in Figure 7 3 3 Cut off OC General Criterion By clicking on the SubstancesO Operators and Numbers you can enter any QC equation that you would like This General Formula option is also access
60. be separated by a comma The keyword characterizes the group It may be matched with a keyword in the Sample ID database or entered for numerical ID when assigning tests for a sample Example Pregnant non smoker Special Group Edit Figure 6 5 2 Special Group Edit Menu Human Diagnostics Worldwide 101 138 Keywords can also be used to determine the group assignment When the keyword is found in the patient database keyword field that patient will be automatically assigned to the defined group It is important to note that the text used to name the Group ID is not searched by the database the user must enter the keyword s used to define the group in the Keyword text box Figure 6 5 3 Special Group Edit Using Keyword s is an example of a special group definition for a pregnant patient Special Group Edit l x Group ID Pregnant Age Range Minimum Age Maximurn Age IY Mot Relevant Any JY Not Relevant Any Gender Not Relevant Any Male f Female Keywords Please enter keywords separated by a comma Keyword ls a word that characterizes the group It may by matched with a keyword in patent database or entered for numerical ID when assigning tests for a sample Example pregnant non smaker pr Caneel Figure 6 5 3 Special Group Edit using Keyword s Refer to the ELISYS UNO Manager section for entering keywords in the Patient Database When running samples with numerical IDs the group can be manu
61. ble that plugs in the back of the diluter Unable to communicate with coprocessor Make sure that the serial cable is firmly connected to both the computer and the instrument Use the cable and adapter if needed provided with the instrument Make sure the ELISYS UNO is powered up See Error Code 010 See Error Code 013 Check levels A problem exists with fluid sensing circuitry See Error Code 013 Make sure you have the proper size bottle not too small or tapered Check that the cap has been removed from the bottle Try adding more reagents Check the probe depth setting for the rack in Instrument Setup Error Code s Problem 022 Large syringe stroke error 504 Plate X axis is jammed 505 Plate Y axis is jammed 506 Wash axis is jammed 511 Wash movement errors Wash aborted Solution Check the assay programs to make sure that the 2 5 ml maximum has not been exceeded Select the Routines tab from the ELISYS UNO Manager menu and click on the Wash Probe option to reset the syringe position Check for physical obstructions blocking the path of the plate in the X direction Check for physical obstructions blocking the path of the plate in the Y direction Select Initialize from the Management tab on the ELISYS UNO Manager menu If the wash head does not lift free loosen the two thumbscrews that connect the wash head to the wash arm Figure 9 1 2 1 ea f MT Figure 9 1 2 1 Possible cause
62. bservation Reference Abnormal abnormal OBX Sequence Number Value Type Value Units Range Flags checking Patient L Sequence Number Count Line Count Batch Number Note A solid bar indicates the field is for future use The bar delimiter is necessary for correct formatting within the record HI VSl IIIT IL P a 2 200502231044 Al Sel III IIIT LIP amp 2 200504121156 F 1 123783479 Doe John Pl i 123783479 Doe John 11111 OBR 1 Example Albumin OBEJ 1 Example Albumin OBR 2 Example Cholesterol O0BZ 1 5T 4 0JoafdaL 3 5 5 2 OBR 3 Example Glucose OBR 2 Example Cholesterol P 2 239393850 Smith Betty QOBE Z ST 137 2 mg dL lt 200 0 OBR 3 Example Glucose OBZE 3 5T 95 3 mgdaL 70 0 110 0 Pl 2 23593593650 S5mith Betty 11111 OBR 1 Example Albumin OBE L ST 3 3 q dL 3 5 5 2 Low QOBR 2 Example Cholesterol QOBE 2Z ST 119 3 mgq adL lt 200 0 OBR 3 Example Glucose OBR 1 Example Albumin OBR 2 Example Cholesterol OBR 3 Example Glucose F 3 450862376 Jones David OBR 1 Example Albumin OBR 2 Example Cholesterol OBR 3 Example Glucose RUE OBX 3 5T 75 2 madL 70 0 110 0 PL 3 450862376 Jones David 1111 Figure 4 4 1 3 Import File Example OBR 1 Example Albumin LIS file extension OBE 1 5T 3 2 g9fdL 3 5 5 2 OBR Example Cholesterol 0BX 2 37 130 9 m9 daL lt 200 0 OBR 3 Examp
63. chniques and components become available HUMAN GmbH therefore has to reserve the right to change specifications if necessary in the course of such improvements Human gt Diagnostics Worldwide Contents 1 shel efel Vie dlc y Reece te ene TET EEE 1 CE TE UC US eae UA A aac ec ec ee ese aac secac a aa cassis 1 P2 e o rare Sil e IP o E O RR 2 1 2 1 Safety Symbols AA 2 A e I 3 E OU O S aaeeeo EEEE EEEE EEEE EEEE EEEE EE EEEE EEEE EEEE EEE EEE EEEE EEEE EEEE EER 5 2 AEREE OVO ate 7 2 ata AA A A A a Gacatsasens 7 2 2 Instrument Check A a 11 3 PING MDS SaR a A A o II III II 13 le E E NAN SU LN O II II ON 14 4 EE IN ON O T 17 4 1 Opening the Software and Security ssssssssssssssssssssssstesssssssteesssssteeesssstteesssstteesssstreeessstteeessssreeesssstreesssstteesssstreesssstteeessssreeesss 17 ALT OPERACION 17 E Pa NO I E rel EG IA is 17 a Ee AU A sos 18 A NIA al gaa gies 80 COR Re ee eae ee een er 19 42i Alignment ninnisi iineoae TPT rT Terre n gt T TET nT TET TTT ETT ETP PT PT TTT Tete Teer HET AOE EEOAE EE OSEERE OEEO ECETIA 19 42 2 lt Rack2 Dispe se pf 24 AP nn nnn eS 25 a A WOM A o 26 424 SA A 27 425 A aU Ng dL anal Paramete Seina reer nse 29 420 RESTOFE ASTUR EA AFABLE SS ppp AA 29 a ES SUN ia 29 4 3 ELISYS UNO EA 30 IS WAV OUT E 1 o 30 A AMS AHO A TaD Benne reer renee eee reer PEr Sree r errr oor oor ore reer rere errr ere cer oor oor ore terre rer rrr rrr ere oecer ooronre ore terrerrer rrr errr errr
64. chronic diagnosis a os Address A Doctor Keyword Custorn Smoker Sample Database Search database C o O O Sample ID Family Name Given Name Middle Name ME DUB RIMAS James irene Bam x oS oe re eee eee F AE O Brown F PERRETE REEE Information entered in the keyword field will be matched to keywords entered in Special Interpretation Groups see Figure 6 5 1 Special Groups in Section 6 5 60 138 Human Elisys Uno User Manual 5 2 2 2 Modify Sample ID Modify Sample ID 1 Select Edit to edit an existing patient s information or create a new one 5 Sample Database Search databaze A rr A 2 Modify the information and then press the Done button to save the changes Elisys Uno A Delete the record with sample ID 122 5223 Delete Sample ID Delete Sample ID 1 Highlight the items to be deleted then press the Delete key on the keyboard A dialog box will open prompting the user to confirm the deletion of the record Press Yes to delete press No to cancel the deletion process Elisys Uno A Delete the record with sample ID 122 Press the Close button to close the Sample DB window Human gt Eee Diagnostics Worldwide 61 138 5 2 2 4 View Log 1 Select the View Log button to view the Patient DB log in Notepad The log will display the modification date time and the change that was made Sample ID PERERA ma Fil Edit 5 h Hel ea AE El
65. complete No Curve Incomplete Incomplete Expired No Curve Incomplete No Curve Incomplete No Curve Incomplete No Curve Incomplete seres v Select all V Remove Export Calibrate Request ox Click on Patient to ae G select Work list rack2 available positions 96 selected JE A Reps Urgent Sa d T z IC MESE 1 JN Click Test or Tests to be added Then click Add Test Print Work List if required Press Request to begin Layout 7 Calibration j Sample a ae S Report Figure 5 3 2 Assigned Assays Management Routines Lot Registration OC Tracking Sample DB Settings Security Help 28153805 Instrument Status Plate temperature SUE Probe temperature 2 Fula ES 37 0 C Temperature is changing to Rack1 UCC prog 00000 F Rack2 12345 00000 00000 00000 00000 00000 00000 00000 00000 00000 00000 00000 00000 Waste bottle HGFEDCBA 0000000801 0000000002 0000000003 00000008 DE 000000000s 0000000006 0000000007 0000000008 0000000009 0000000010 0000000011 0000000012 Figure 5 3 3 Layout Tab with Load Positions Emp a T ectiuction Locations for Name ID Position samples outlined Creatinine Picric A1 Rack1 1 Creatinine A2 Rack1 27 Calcium CPC Reagent Rack1 5 Calcium Buffer Reagent Rack1 6 122 211 Rack2 F All Rows Rack2 8 Row 1 Row 2 Use these Row 3
66. down menu to select the units of measure for an assay Figure 6 4 2 Select Units 2 of Decimals Choose the number of decimal places needed for results 3 Normal Range Choose this option to set the range which identifies that a Sample is normal If a result is out of normal range it will be interpreted as High or Low You can also define the linear valid test range If a result is out of linear valid range it will be interpreted as Above linear range or Below linear range gt Interpretation Settings Units ES Normal Range C Positive Negative ImbLI4L of Decimals Mormal E to 16 2 Linear to e Figure 6 4 3 Normal Range Choose this option to set the range which identifies that a Sample is normal If a result is out of normal range it will be interpreted as High or Low 98 138 Human Elisys Uno User Manual 4 Positive Negative Interpretation Settings Units mg dL of Decimals Poz gt C Normal Range e Positive Negative fi Meg z Special Groups Reversed Figure 6 4 4 Positive Negative Choose this option to set Positive and Negative limits Results will be interpreted as Positive or Negative Samples in a range between the Positive and Negative limit are interpreted as Equivocal Check the Reversed box to switch the settings see below Positive Negative Fos lt Neg gt
67. e Edt Seah Nep A EREE HHMHH SNH pee eho Given Name James gt James Hiddle Hame Jerome gt Jero SPR DOB Address gt Doctor Barry gt Barry Keyword gt oker Custom gt fHodify 16 16 05 2 22 13 PH Sample ID 123 gt 123 Family Hame Brown gt Braun Given Hame James gt James Middle Hame Jerome gt Jerome Sex DOB Address gt Doctor gt Barry Keyword smoker gt Smoker Custom 5 2 2 5 Import Patient Record Import Patient Record 1 Click to highlight the Sample ID to export Select the Import button to migrate the selected record to a text file in Notepad EA la IO E II OK Migrate data by importing a text file exported from MS must be Tab as delimiter No text qualifier Field name on first row and First field is an unige key Keyword Custom Excel MS Access MS SOL Server etc The file format is relationship between fields 122 es IEA FRRRERAS Database Field Text File Field Sample ID Family Name Given Name Middle Name T Do not update record if its sample ID exists Progress ar IE Sta m E 55 ai pan a OO e Close 62 138 Human Elisys Uno User Manual 5 2 2 6 Export Patient Record Export Patient Record 1 Click to highlight the Sample ID to export Select the Export button to send the selected record to the Sample Record text file in Notepad f Samy F Sample Record txt Notepad Fa
68. e SD 1 054 Cone CV 11 341 5 Edit QC points 1 0162 Abs 76 6 mg dL 2 0 164 Abs 77 6 mg dL 077 3 0165 Abs 78 0 mg dL 077 4 0 168 Abs 79 5 mg dL 077 5 0 167 Abs 79 0 mg dL 077 Te ME 0 167 Abs 79 0 mg dL 077 E M7 0 170 Abs 80 4 mg dL 077 i E78 6 8 0 167 Abs 79 0 mg dL o fE M39 0168 Abs 79 5 mg dL 077 fE 10 0164 Abs 77 6 mg dL orig 775 11 0 172 Abs 81 4 mg dL 077 12 0 170 Abs 80 4 mg dL 077 765 7 13 0 171 Abs 80 9 mg dL 077 14 0 167 Abs 79 0 mg dL 077 Y 15 0 165 Abs 78 0 mg dL oza f 754 gt QC Points By absorbance ees By concentration Detras Figure 4 4 4 3 Edited OC Report The OC Report can be printed The curve can be viewed by Absorbance or by Concentration results 4 4 5 Sample DB Refer to Section 5 2 2 Sample Database Setup for details 4 4 6 Settings Refer to Section 4 2 Alignment Settings and Section 5 Running ELISYS UNO for details on Software Settings and Custom Report Settings 4 4 7 Security Refer to Section 4 1 2 Password Security and Logging in for more information 44 138 Human Elisys Uno User Manual 44 8 Help 4 4 8 1 Self Test Self Test presents the user with the status of the instrument by recording data into the Self Test log in Notepad The self test requires the ELISYS UNO Performance check kit Cat No 17350 11 Refer also to the corresponding leaflet page 47 The Performance check kit is used for blanking the instru
69. e defined in the Add Sample Step When checked the Advanced button is enabled 108 138 Human Elisys Uno User Manual x p NOTE Aspiration Speed parame Air Gap 2 TN Dispense Speed 2 E Moni Dispense Height Low v Blank Used C i Cancel Figure 6 8 5 Advanced Aspiration and Dispense Aspiration Speed The acceptable range is O to 4 where 4 is the fastest speed Default speed is 2 Air Gap Amount of air in microliters that will separate the substance being aspirated from the de ionized DiH20 water aspirated It separates prime bottle substance from the aspirated substance Default values are automatically selected based on the aspiration volume Pre warm Time Some tests require you to pre warm the standard after aspiration before it is added to the well The pre warm time can be set here Dispense Speed The acceptable range is O to 4 where 4 is the fastest speed Default speed is 2 Dispense Height There are two different levels of dispensing you can choose from High or Low 3 Arrow Buttons Select a Standard in the list to the left and click the arrow for the direction in which to move it in the list reference Figure 6 8 1 4 Remove Select a Standard from the list on the left and click Remove to eliminate it from the list see Figure 6 8 1 Human gt Diagnostics Worldwide 109 138 110 138 Human Elisys Uno User Manual 7 Enzyme Immuno Assay Edito
70. ection 5 and run Start of Day before performing Channel Blanks for the first time if this has not already been done with the Quick Start Guide Select Channel Blank from the Settings gt Alignment menu dialog Settings Security Help Alignment t Probe vs Racki Software Probe ys Rack2 Custom Report A A Probe ys Plate Probe ys Wash Cup Washer vs Plate Rack Dispense Height o Channel Blank Channel Blank Display Instrument Parameters Restore Instrument Parameters Figure 4 2 4 1 Select Channel Blank from Settings menu This will allow the user to blank the four photometer channels on a wetted optically clear solution example blanking solution included 0 5N NaOH with 100uL Triton X 100 L The ELISYS UNO software will show which wells it will be using for channel blanks preferably use a new set of wells and then prompt to put Blanking Solution in position 1 of Rack 1 never use plain water Reset Channel Blank xj Please load wetted material to Rack1 1 and make sure wells 407 001 404 and DO4 are all empty Click Start button to run OOSoooCeocooocga 0000000000000 000000000000 000000000000 000000000000 Result Close Figure 4 2 4 2 Load the wetted blanking material into position Human O Diagnostics Worldwide 27 138 The ELISYS UNO will then pipette the four blank wells read and store them then do a confirmatory reading The absorbance values o
71. een and allows you to login with a different name and password Logout You are logged out and the Login screen appears and waits for next user Press Cancel to quit Assay Editor Create New User Create a new user with ID password and security level The manager can create users but will only be able to give them Operator level security Remove User Administrators can remove any user Managers can only remove operators Change Password Any level can use this feature Enter your old password followed by the password you want to change it to Human gt Diagnostics Worldwide 81 138 Who is Logged In Security Access window appears to show who is logged in and their Security Access Security Access xx MON Logged in Admin Security level Administrator Figure 6 1 6 3 Who Is Logged In View Log File Displays a text file listing logins anything that has been modified date time and by whom 6 1 7 Settings iby Help i Printout Font Filters Select Language Figure 6 1 7 1 Settings Printout Font Allows user to select a font style for printouts O Arial Unicode MS Ena Arial T Arial Alternative F Arial Alternative Symbol Arial Black O Arial Narrow O Arial Unicode MS Sample AaBLbYy z Figure 6 1 7 2 Printout Font selection Filters Displays the currently installed filters in a particular instrument Filter Settings The chosen set of filters will be used for programming
72. egistration QC Tracking 85000540 Choose tests Test A 10ulSample A 10ulS ample Read A Absorbance A Anti HAY DiaS arin A Anti HAY DiaSorin sho Antas orin Anti HAV_ A Anti HBc DiaSorin Anti HBc DiaSorin short A Anti HBc_ A Anti HBe DiaSorin Anti HBs DiaSorin Anti HBs_ A B 2 Micro MixFix 3Wash A B 2 MicroG Washtest B 2 Microgl MixFix Wa A 8 2 Microglobulin A B 2 Microglobulin MixFix A B 2 Microglobulin MixFix A B 2 Microglobulin MixFi A B 2 Microglobulin MixFi A 8 2 Microglobulin NoDi A B 2 Microglobulin testw A BVDV Unitech A BVDV Unitech A CMY IgG DiaSorin A CRP CRP BioCheck A CRP BioCheck MixFix AA CRP BioCheck _ AX CRP dilutiontest a Enter sample IDs ID Total 2 Add Numerical ID Add Sample ID Re Sample DB Settings Security Help Current Calibration Status Incomplete Expired No Curve complete retive Incomplete No Curve Incomplete No Curve Incomplete No Curve Incomplete No Curve Incomplete No Curve Incomplete No Curve Incomplete No Curve Incomplete No Curve Incomplete Incomplete Expired No Curve Incomplete Incomplete Expired No Curve Incomplete Expired No Curve Incomplete Incomplete Expired No Curve Incomplete No Curve Incomplete No Curve Incomplete Invalidated Abnormal Expired No Curve Invalidated In
73. eps ce 117 De E EE E h E PEA 118 8 ENSYS UNO Mana ser aid EUGA Senrose ae ae ERRER 121 Se RURO Po near enerr ener ener ere 121 8 2 Accepting and Adjusting Standard CURVES i 125 9 A OO 133 A A as 133 A ele E 133 P ERORAR a a E TOTO PE Ter TO PTO IT Tern nO TT Or TORT eT erer nO Tee TOIT 135 ii iv Human Elisys Uno User Manual Human as ae Diagnostics Worldwide ii iv iv iv Human Elisys Uno User Manual 1 Introduction ELISYS UNO is a computer controlled instrument system capable of automating any or all stages of ELISA assay processing that involve these functions e Fluid Handling aspirates and dispenses from 5 uL to 1 95 ml e Incubating heating temperatures coil heats to 37 C plate heats to 25 C or 37 C or no temperature control ambient e Mixing reaction plate only e Timing from 1 second to 24 hours e Optical Reading UV visible range e Calculating uses numerous pre programmed equations e Data Storage unlimited capacity e Data Reporting many options and customisations to choose from The system allows one to define and program an unlimited number of customised protocols by selecting displayed menu options from a Microsoft Windows software program see Operating Precautions Section 1 4 ELISYS UNO may also be used in production processes involving micro volume dispensing diluting incubating and reading ELISYS UNO is a unique automatic system Reactions occur in standard plastic microwells
74. eselect it 3 Work List Lists the IDs and assays assigned to each requested copies and a column labelled Urgent where checkboxes appear To add more copies to a test highlight that row and use the hidden pull down to change the number If it is important to get certain Patient ID s sampled first check the Urgent space that corresponds to the Patient ID in question To remove a Patient click the row and press the Remove button You can then print the work list and or press the Request button When you choose Request the layout tab opens Verify the location of all samples and press All Are Loaded when done loading the racks The test will now begin 34 138 Human Elisys Uno User Manual 4 3 3 Test List Tab Management Routines Lot Registration GC Tracking Sample DB Settings Security Help 204158005400 Highlight By Name ID y Highlight By Assay Current Step None Name ID TimeLeft Absorbancg Concentration Interpret Beak AQ 4 F Select all Layout Figure 4 3 4 1 Test List Tab 1 Layout Indicates the location of patient samples reagents and pertinent assays For more information on a particular substance highlight it with the mouse cursor 2 List Use Highlight by Name ID drop down menu to highlight a patient or use Highlight by Assay drop down menu to highlight by type of assay All of the assays are listed and the Current Step that is
75. et inside the tube to eliminate splashing and loss of sample High should be set as high as possible to thoroughly mix the sample diluent but not high enough to cause reagent foaming Use the top set of three buttons to select the High dispense height and the bottom set of three buttons to T Test with your particular reagents for appropriate dispense heights Click Save on each to save the new settings then click Close Rack Dispense Height X Dispense High 42 Please wait Close Figure 4 2 2 1 Adjust Probe Dispense Height Human gt mo Diagnostics Worldwide 25 138 4 2 3 Filter Voltages Select Filter Voltages from the Routines menu anager Chemistry Routines Lot Registra Start of Day End of Day wash Probe Prime Syringes Prime Washer Prime Rinse Temperature On Temperature OFF Filter voltages Read Wells Custom Script Figure 4 2 3 1 Select Filter Voltages from Routines menu Press the Test Current Voltages button to view the filter voltage readings for all four channels at each of the eight wavelengths If nothing happens wait for the automatic lamp warm up time Filter Voltages x Click the Test button to retrieve current filter voltages You may want to save current values for quality control purpose The data is dizplaped in the format of Current Stored Difference Filters Channel 1 Channel 2 Channel 3 Channel 4 2 566 5
76. f the readings will be displayed and should be 0 0 0050A These blanks will automatically be subtracted from absorbance readings Reference Figure 4 2 4 3 notice at the bottom of the window the Result is displayed Reset Channel Blank Please load wetted maternal to Rack1 1 and make sure wells 401 001 A04 and O04 are all empto Click Start button to run Plate HGFEDCEA 100000000 O0 0 OIDOS M06 dd o Ob os M Mag Result OO OO Po OO 12 PASSED channel blank haz been reset with correct values 401 0 0006 001 0 001 2 404 0 0006 O04 0 001 4 Figure 4 2 4 3 Reset Channel Blank Results If one of the values is not between 0 0 0050 follow the instructions and try doing channel blanks again Do make sure there are clean wells in the positions indicated to run channel blanks again 28 138 Human Elisys Uno User Manual 4 2 5 Display Instrument Parameters Choose Display Instrument Parameters in the Settings menu Notepad opens and the following text is shown File Edit Format View Help B 31 2005 10 19 54 AM Figure 4 2 5 1 Notepad file This file can be saved and or printed or filed for future reference 4 2 6 Restore Instrument Parameters Select restore instrument parameters to restore parameters from the copy saved at the last initialization Restore Instrument Parameters xj Restore instrument parameters from the copy saved st the last initialization seen 4 2 7 ELISYS UNO
77. ghlight By Name ID Highlight By Assay 7 Current Step None Time Left Absorbance Concentration Interpretation Tal TSH Complete 0 233 Abs 1 2 WU mL T a2 TSH Complete 0 316 Abs 1 7 Wem T R 3 TSH Complete 0 322 Abs 1 8 plU mL T R 4 TSH Complete 0 246 Abs 1 3 plU mL Tas TSH Complete 0 434 Abs 2 5 W m T R6 TSH Complete 0 163 Abs 0 7 wWU mL az TSH Complete 0 361 Abs 2 0 plU mL T R8 TSH Complete 0 638 Abs 4 0 Uml 09909000 R 9 TSH Complete 0 311 Abs 1 7 wm pb ap pth ded E R 10 TSH Complete 0 396 Abs 2 3 WU tl 00000000 00000000 00000000 0009000000 00000000 0000900000 000900000 900000000 0009000000 000090000 29900000 9090000000 90009000000 0009000000 00000000 000000090 29900000 20900000 lt M gt ssssseee PS 29900000 l Select all Accept Delete View Schedule He ae eee a ee Oe Layout y Calibration 2 Sample 107 Test List Report Figure 8 2 13 TSH Standard 5 Results 130 138 Human Elisys Uno User Manual 9 Troubleshooting 9 1 Flags and Error Messages Flags are warning messages to the user of a possible problem condition that will need to be corrected The instrument will continue to operate under these conditions An example of a Flag is Wash Bottle is Low Error Messages indicate a condition that causes the instrument to be unable to proceed and must be corrected before the instrument is used further An example of an Err
78. he items in the work list and click the Remove button to delete them from your worklist Press the Request button to go to the layout tab to load and verify the locations of the reagents calibrators etc 5 Activate Selected Button To edit the curve check the curve records choose part of curve records which look good to user then click the Activate Selected button This button will be enabled once the software calculates based on time logic math etc a valid curve After activating new curve records the current curve is changed The software will look at the test list to recalculate all finished tests of this assay 6 Discard Recent Upon accepting the new adjusted curve with the settings in Strategy Settings set to Auto the option to discard recent is no longer available Reference Accept Curve and Control Results Menu in Section 5 1 4 Strategy Settings However if Strategy Settings remain defaulted to manual the user has the option to discard recent and return to the previous curve With Strategy Settings set to Manual the new concentration values will display however the original values remain allowing the user to discard recent 7 Print Preview Preview calibration and control results before printing statistics such as CV Dif and mean values are also shown 8 Print Report 9 Curve Button Toggles between substances selected calibrators controls and calibration curves
79. he menu To check the current alignment click the probe button 20 138 Human Elisys Uno User Manual Alignment Continued To check new alignment select Test When finished click Save then click Next to continue with Step 2 of 2 The next step prompts to replace Rack 2 and place a sample cup in Probe vs Rack Step 2 of 2 x position number 96 in the back of Now load Rack back and put a sample cup in E position 96 Use buttons to adjust the masimum probe sample rack view Figure 4 2 1 foie 3 Figure 4 2 1 3 Step 2 Adjust Probe Depth for Rack2 NOTE Select Close to pass the option to set an alternate depth Otherwise select the probe button a Use the arrow keys to move the probe until it almost reaches the bottom of the sample cup When the correct depth has been reached click Save and then the Close button Human gt mo Diagnostics Worldwide 21 138 Alignment Continued Select Probe vs Plate from the J menu Settings Security Help Alignment b Probe vs Rack Probe vs Rack2 E Software Probe vs Plate Custom Report Probe vs Wash Cup DE _ Washer vs Plate Rack2 Dispense Height Channel Blank Display Instrument Parameters Restore Instrument Parameters Insert a plate or strip tray into position when prompted Probe vs Plate AS Please wat Figure 4 2 1 4 Adjust P
80. he probe so that the probe tip will remain just below the liquid surface when the aspiration is finished This calculation is based on the diameter of the rack hole cut out and it assumes a straight walled bottle If a much smaller diameter bottle or a conical vessel is used the liquid surface will descend faster and could result in the aspiration of some air and less than the desired reagent volume Human gt ae Diagnostics Worldwide 131 138 Liquid Surface Reagent Reagent Reagent Bottle Bottle gt Bottle Area of Area of Area of Error Error Error Rak iii Rac IM Rack i Correct Too Narrow Conical Figure 9 1 1 1 Probe Insertion Depth Illustration Lesson Pipette errors may occur if reagent bottles are used which have a smaller diameter than that for which the rack was designed This can result in inaccurate volumes or no reagent being dispensed to some reaction wells Flags Continued Wash Rinse Bottle Low When the wash or rinse bottle is low you will be warned as appropriate The software will automatically check the status of the bottles when preparing to run assays Refill the bottle s before starting the assays If one of the bottles becomes low during the run the Error Status Board will display a message Wash bottle empty or Rinse bottle empty and will continue to perform the wash with the remaining solution To refill the wash bottle select Pause Engine from the Management Menu Refill the wa
81. he remaining calibrators from the stored curve This feature can be used to control for changes in reagent activity when using stored curves In the Figure 8 2 10 TSH Adjusted With Standard 5 TSH Standard 5 is used to adjust the stored curve shown in Figure 8 2 6 TSH Curve 0 Factor Instead of requesting an entire new curve Standard 5 is requested individually TSH Incomplete Abnormal v Add calibration test y Curve recent white current blue backup gray Control current pink Criteria Show backup Work list Name Absorbance Concentration Interpretation ha Assay Name 4 18 2005 9 40 44 AM TSH Standard 5 TSH Standard 1 0 011 Abs lt 0 0 plU mL Dut LA TSH Standard 1 0 010 Abs lt 0 0 plUl Out LR TSH Standard 2 0 246 Abs 0 9 plU mL TSH Standard 2 0 244 Abs 0 9 plU mL TSH Standard 3 0 455 Abs 2 1 plU mL TSH Standard 3 0 463 Abs 2 1 plU mL TSH Standard 4 0 854 Abs 4 4 plU mL TSH Standard 4 0 868 Abs 45 plUmL TSH Standard 5 1 716 Abs 10 5 llr TSH Standard 5 1 697 Abs 10 3 plU mL TSH Standard 6 2 607 Abs gt 25 0 plU mL Dut LR M TSH Standard 6 2 563 Abs 22 9 wll n Copy gt Save Request Print Preview Print Report Factor lox Load Remove Figure 8 2 10 TSH Adjusted With Standard 5 In this example TSH Standard 5 yielded an absorbance value of 1 366 This is an absorbance drop compared to the Standard 5 absorbance va
82. hoose a location enter a name and press OK Press Request the Layout tab will open kipina iie Fii hrpa 56 4 T Proba anpara Sa et Torgaun E charra ADT 04 O 100000 1000900 66 Hors Macia baie itech boti Fam baia Piana a Char Cabral AE Oe te eS eS 64 DPOPOAPADT BSDSOS OS a DPOPOAPOD A DOS Ga Hora nea ERA HG 4 E Z a IA Aiea ma 000 01 F Aol 203 t sO T Ami SOSORSRBBos E Aw BaSaSHSH 04 M Ami Hii 05 F Roet Spa MODO D M Aem OF E How o O Pel PAOLO M Ac mi D2 f Rog tats SOS S10 A Rev id POP OPS pov PDPO M Ami HoH Verify locations Figure 5 2 3 5 Verify Reagent Calibrator and Controls Are Properly Loaded Laag kinai oe Pop Fiacki 1 Hagari Fiacki a fa k tristan Fas Make sure your Jal Ifi sel nm reagents are loaded Charm Cabbradar Had i oe ine properly Press All are Loaded if placements are OK Carcel PM sas bene Diagnostics Worldwide 67 138 Load Sample and Reagent racks as instructed and press the All are Loaded button refer to Figure 5 2 3 5 Verify Reagent Calibrator and Controls Are Properly Loaded The Test List tab opens and the ELISYS UNO begins the run The status and current step are both shown Management Routines Lot Registration GC Tracking SampleDB Settings Security Help 8535600200 Highlight By Name ID y Highlight By Assay y Current Step None Figure 5 2 3 6
83. iagnostics Worldwide 17 138 4 1 3 Security Menu Options Enabled When Enabled is checked the password protection and security restrictions are being used ELISYS UNO can be set up with or without a password security system To remove the password security system so that a login is no longer required go to the Security menu view Figure 4 1 3 1 and uncheck Enabled With Enabled checked the security system is on Only Administrators have access to this option Security Help w Enabled Log in as different user Log aut Create Mew User Remove User Change Password Who is logged in View Log File Figure 4 1 3 1 Security Menu Options Login as Different User displays the Login screen and allows you to login with a different name and password Logout logs current user out of the system Create New User creates a new user with ID password and security level The manager can create users but will only be able to give them operator level security Remove User Administrators can remove any user Managers can only remove operators Change Password Any security level can use this feature Enter the old password followed by the new password Who is logged in Security access window appears to show who is logged in and their access level view Figure 4 1 3 2 Security Access xx Ady Logged in Admin Security level Administrator Figure 4 1 3 2 Security Access Window View Log File opens a l
84. iagnostics Worldwide 77 138 6 1 3 Substances Use this menu to choose one of the Substances and manage the list Managing the list refers to adding New Edit or Delete current Substances Panels Reagents ELA Controls Standards ne New say El Were Figure 6 1 3 1 Substances Menu 3 AA X Ma b vWF AFP Conjugate AMA M2 IgG Buffer New Mama M2 IgG CONJ Mana LIA STOP Edit Mana Lia SUB E ANA Screen cut off CONJ Delete MANA screen CONJ BB ANA Screen cut off CON MI ANA ENA Combi CONJ Mi Annexin Y Screen CONJ BB Anti Cig AB CONJ BB anti sp 100 AB loG Buffer BB anti sp 100 AB IgG Conjug anti HBc Conjugate anti HBs Conjugate anti HCY Conjugate anti H S aranle Nik ient Figure 6 1 3 2 Manage Reagents 3 mn X A Controls SS B L4 4B NC Close MM ss 8 L4 48 PC J Wi ssDNA NC BB ssDNA PC ES Syphilis PC MTG Ak Nc MBG ax Pc M Toxo IgG Neg Cntr WB Toxo laG Pos Cntrl High BB Toxo laG Pos Cntrl Low E Toxo IgG Pos Cntrl Medium MTP NC Mirrc M Transalutam IgA NC WB Transalutam 194 PC MA U1 snANP A4b NC BB U1 snRNP Ab PC Mi vwF PC Figure 6 1 3 3 Manage Controls 78 138 Human Elisys Uno User Manual Standards i i Chemistry Calibrator MA HB 249 Neg Control WH HB 49 Pos Control MB HDL LOL Calibrator New HY Non Reactive Control PO Hlv 1 Ab Reactive Control Edit HI 2 Ab Reactive Control E Micro Protein Standard Delete E
85. ible from the OC button in assay modes other than cut off mode Cutoff UC general criterion Substances double click Operators Backspace IS n Meana B lank ABS HOL LOL Calibrate Cancel Mean4 HDL LDL amp F amp l CONCIHOL LE MeanlJAQL LOL Calibrator Figure 7 3 3 Cut off OC General Criterion 118 138 Human Elisys Uno User Manual 8 ELISYS UNO Manager and ELISAs 8 1 Running ELISAs 1 Open the Calibration Tab to add the curve s necessary for the Assay s being run Controls should also be selected at this point Next go to the Sample Tab to enter the patient samples to be run Clicking Request will then process the standards control and samples together as a batch For ELISAs standard values are set in the assay editor and entering lot numbers for standards is optional 2 Click on the Sample Tab in order to enter the patient samples 3 Click on the Request button You will be asked to confirm addition of the calibration standards and asked whether to use a new plate If defined Special Interpretation Groups are in the Assay s being run the Interpretation Group window Figure 8 1 1 Interpretation Group is displayed otherwise the Work Schedule Figure 8 1 2 Work Scheduler is displayed Using Special Groups Interpretation unique normal ranges are used for different group definitions Interpretation Group For a patient ID interpretation group has been determined based on patient s sex age and
86. ing ELISA Assays This section gives a broad overview of creating a new Assay Refer to Chapter 7 for detailed information pa E E E Assay Editor Assay View Substances Panels Indices Security Settings Help y E HE GOAN X Assay Name New Assay EIA Assay Mode Standards Type EA Version 1 Absorbance gt Temperature Room Temp v C V Flat bottom wells Assay Description Curve Valid Time b a Pe Es ell EL LEE Interpretation Settings C Normal Range C Positive Negative Assay Steps Add Step ae an f Blank Used Sample Run samples as doubles OC Criteria Copy Sten Controls Units Conc H of Decimals 1 v Figure 6 2 1 For ELISA Assays 1 Assay Name Enter a name for the new Assay 2 Assay Type Indicates ELISA Assay is being programmed 3 Temperature 4 Assay Description Entering a description for the Assay is optional However a short description of the edited or newly created Assay is recommended 5 Assay Mode There are ten ELISA Modes Assay view Substances Panels Indices Security Settings Help wt Hos oan X Y Assay Name New Assay EIA Assay Mode Tye EA Version 1 Absorbance Temperature Room Temp E Cut Off Cut Off Standard I Flat bottom wells Paint to Point Assay Description j Linear Regression Cubic Spline Constrained Dose Response Figure 6 2 2 Assay Definition Section 84 138 Human Elisys Uno User Manual Absorbance Mode
87. ing system re prime it with deionised water and rinse the wash head if applicable with deionised water It is optional whether you turn the unit off or not NOTE It is important that you place deionised water in the Rinse bottle prior to running End of Day 72 138 Human Elisys Uno User Manual Notes Human gt Diagnostics Worldwide 73 138 74 138 Human Elisys Uno User Manual 6 Assay Editor Assay Editor works in conjunction with ELISYS UNO Manager Although all HUMAN Methods are included and pre programmed in the ELISYS UNO Manager software it is possible to add new methods by choosing Launch Assay Editor in the Utilities menu NOTE Chapter 7 if included with this manual details the use of Assay Editor for programming Enzyme Immuno Assays ELISA E Assay Editor Assay View Substances Panels Indices Security Settings Help y E HES ida XF Welcome to Assay Editor Please use the toolbar BUTTONS ABOVE to open or create an Assay Create a NEW EIA assay i Settings Mies Security Help Alignment j Open an existing EIA assay Chantal bl nt i Self Test Waste bo Filter Voltages Wash Bot Launch Assay Editor Biase Gol Launch Pack hize Datl Launch Report Creator 4 Plate You may also use one of the first four menu items under Assay t og 4 o TEDL EA oo ai COODODOOO 01 Figure 6 1 Welcome Screen user software menu Access Assay Editor by pressing the icons or click on the drop
88. keyword Make sure they are correct For a numerical ID the information will not be stored but you can use it to let the software automatically decide group for you You can always choose group directly for each test Default interpretation will be used if no group is chosen Information of R 3 Interpretation Group planet Estradiol Child prepubertal Estradiol Female pregnant Estradiol Estradiol Male Keyword Female postmenopausal Estradiol Female ovulating Female pregnant Child prepubertal Used in current tests child male F ovulating postmenopausal pregnant prepubertal Used in other tests early follicular l female F follicular phase late follicular luteal Update Figure 8 1 1 Interpretation Group When multiple Assays are run simultaneously the software will automatically generate the best run order based on the shortest total completion time The desired run order can be changed by selecting an alternate schedule The software will delay the start of certain assays so that conflicts do not occur Human Do Diagnostics Worldwide 119 138 EIA Work Schedule Different schedules are available based on assay starting order Please choose Schedule 1 Time Cost 01 48 05 v Schedule 1 Time Cost 01 48 05 Schedule 2 Time Cost 01 48 19 an nn Schedule 3 Time Cost 02 05 31 00 30 00 01 00 00 Schedule 4 Time Cost 02 06 01 Schedule 5 Time Cost 0
89. le Glucose OBX 3 T 126 8 mg AL 70 0 110 0 High L 3 23 Figure 4 4 1 4 Export File Example LIS file extension Human gt ae Diagnostics Worldwide 41 138 442 Routines Menu OPTION Start of Day End of Day Wash Probe Prime Syringe Prime Washer Prime Rinse Temperature On Temperature Off Filter Voltages Read Wells Custom Script 42 138 Human Elisys Uno User Manual Skies Sobers erect Routines Lot Registral Start of Day End of Day Wash Probe Prime Syringes Prime Washer Prime Rinse Temperature On Temperature OFF Filter Voltages Read Wells Custom Script Figure 4 4 2 1 Routines Menu DESCRIPTION Refer to Section 5 2 1 Run Start of Day for more information Refer to Section 5 5 End of Day for more information Select Wash the Probe and reset syringe positions Primes the fluid handling system with the liquid in the Prime bottle Primes the wash system with the solution in the Wash bottle Primes the wash system with the solution in the Rinse bottle Enable and disable temperature control Refer to Section 4 2 3 Filter Voltages for more information Enables selection of wells to be read selection of filters primary and differential number of reads and to use or not use a stored blank Select the Clear button to remove all of the results Select Export to send the results to a text txt file Allows scripts to be run consisting of a serie
90. lect Software Select a communications port and click OK Software Settings 3 x Sample Database What to do after software starts Shrink test database Keep sample ID records 30 days y 3 years y 0 Chemistry Washing 0 Chemistry Strategy AGB EIA Strategy 2 Report 4ppearance 42 Report Output Communication Port Communication Handshaking Communication Speed fi 9200 y Default temperature El Mode Room Temperature y Keep numerical ID records Connect to instrument Figure 2 1 10 Software Settings The Default Mode is greyed out if working with an instrument with no washer Reference Figure 2 1 10 10 138 Human Elisys Uno User Manual 2 2 Instrument Check Out With the instrument connected to a computer start the ELISYS UNO software and switch on the instrument When the instrument powers up note the following actions All racks move to the front home positions The probe moves to its home position to the left over the plate and then to the wash cup The syringe pump primes The instrument and the optical system lights come on These events are controlled by firmware installed in your instrument however the software must be running for proper operation If the instrument s power comes on but these actions do not occur and the beep sound continues there is a problem with the communications setup Check the serial cable connections and COM p
91. lisys Uno User Manual Tungsten Xenon lamp 405 450 490 630 Long life hard coat ion assisted deposition 2nm 10nm typical half band pass 0 2 to 3 0A 1 of the reading 0 005A from 0 to 1 5A 2 of the reading 0 005A from 1 5 to 3 0A Software Format Operating Systems Minimum System Recommended system Secondary menu options Calculation modes Self monitoring modes QC options Serial port Power Voltage Range Frequency Range Power Maximum Environmental Conditions for Safe Operation Mains supply voltage Altitude Humidity Temperature Recommended Environmental Conditions Operating Temperature Operating Humidity CD Rom and Internet upgrades Windows 98 2000 ME NT 4 0 or XP Pentium 133 MHz 64 MB RAM SVGA monitor Serial port or USB port with Serial adapter Pentiumll 333 MHz 128 MB RAM CD drive Windows 98 or above Create edit protocols import export data etc Control Run Setup Absorbance single standard factor fixed time kinetics kinetics by standard or factor multi calibrator point to point linear regressions log logit cubic spline and nonlinear regressions curve fit Lamp bottle volume filters pressure vacuum mechanical function and more Store control data print Levey Jennings or QC range plots calculate SDs RS232 output only 19200 Baud 1 start bit 8 data 1 stop no parity no handshake Serial cable provided
92. lues of the stored curve By selecting this standard and all the stored standards the new adjusted curve can be activated 128 138 Human Elisys Uno User Manual TSH Incomplete Abnormal Recent Add calibration test y Curve recent white current blue backup gray Control current pink Criteria Show backup Work list Absorbance Concentration Interpretation The curve based on selected records 1 366 Abs gt 1 366 Abs gt 10 4 wlU mL Request Aemave Calibration Aur 8 2 11 TSH rre A Once activated the original absorbance values remain but the new calculated concentration values of the standards are displayed TSH Incomplete Abnormal v Add calibration test y Curve recent white current blue backup gray Control current pink Criteria Show backup Work list Interpretation The curve based on selected records No Data Absorbance a an o o o a o PP a Activate Selected Discard Hecent Save equest Print Preview Print Report Factor ox Remove Calbraion Figure 8 2 12 Activated TSH Adjusted Curve Human gt Diagnostics Worldwide 129 138 Even though the samples show decreased absorbance values similar to the one adjustment standard run the resulting concentration values for the samples are the same as when they were run with the original complete standard curve see Figure 8 2 7 TSH Results Hi
93. ment and to verify the instrument s pipetting precision reading reproducibility and photometer accuracy Content of the kit SOL1 120 ml Performance Blanking Solution NaOH 0 1M Triton X 100 0 01 SOL2 23 ml Performance Blanking Solution NaOH 0 1M Triton X 100 0 01 7 ml PNP Solution Para nitrophenol PNP 3 mM NaOH 0 1M Triton X 100 0 01 It is necessary to supply an empty sample vial for to be used when self test is running is intended to refill if required From the ELISYS UNO Manager main screen select Help followed by the Self Test option Sample DE Settings Security Help Launch Assay Editor Launch Pack Waste bottle E aste bottle r About Wash bottle Fu Human gt Diagnostics Worldwide 45 138 Self Test Please load NaDH Diluent in Rack1 1 PNF in Rack2 1 and make sure the plate ts empty Then click Start button to run Rack Rack2 CODODOdOAl COODOCOdA ia 000000000000 46000000 DIDE COODOODOODODODOO OODODOOOODOO Var 1O0dABAAIBBAADA Result Test Progress Metals Close Self Test To begin the test the user selects Self Test from the utilities menu The user then places the bottle containing 23 ml of in position 1 of the reagent rack and puts an aliquot of the in a sample vial placed in position 1 of the sample rack After loading the solutions and inserting a clean plate into the instrument the Start button is pressed and the self test is performed Afte
94. min Mio l T3 Standard 5 T3 lt 66 min oe T3 Standard 5 T3 lt 66 min 00669909 T3 Standard 6 T3 lt 66 min 900009009090 I T3 Standard 6 T3 lt 66 min 90000000 M R 1 T3 lt 66 min o90000090 Maz T3 lt 66 min 90000000 M R23 T3 lt 66 min ee l R 4 T3 lt 66 min Tas T3 lt 66 min M R 6 T3 lt 66 min Far T3 lt 66 min v90000090 Tas T3 lt 66 min 90000000 M 9 T3 lt 66 min SOBOOOO M R10 T3 lt 66 min cosoo M T4 Standard 1 T4 lt 75 min Eee FT T4 Standard 1 T4 lt 75 min I 00000000 9000090009 7 38883883 I Select all View Schedule Fiesune A _ Test List Report Layout yo Calibration 2 Sample Ready NUM Di Figure 8 1 4 Test List Right clicking on any of the Sample rows will display the Step Log refer to Figure 8 1 5 for that Sample This can be helpful for verifying that all the Assay events have occurred reasonably on time For example if a reagent runs out during a test and has to be refilled the timing in this window can help determine whether to accept a result or delete it Step Log Name ID T3 Standard 1 Assay T3 Interp Group Request Time 4 15 2005 2 00 55 PM _AssayStep_ ChemWell Step _ Parameter Statt Time Finish Time ADDSAMPLE ADDSAMPLE ADDSAMPLE ADDREAGENT ADDREAGENT ADDREAGENT WAIT ADDREAGENT ADDREAGENT ADDREAGENT CLEANPRB CLEANPRB RINSEPRB WAIT ElAWASHWELL ElAWASHWELL ElAWASHWELL ElAWASHWELL ElAWASHWELL EIAWASHWELL
95. mple results bianual lah i 54 138 Human Elisys Uno User Manual 5 1 2 3 Report Appearance Software Settings Continued OPTION DESCRIPTION Specify your preferences on the report appearance se 18 Report Appearance 8 Report Appearance Human Diagnostics Worldwide 55 138 5 1 2 4 Report Output Software Settings Continued OPTION DESCRIPTION Specify optional data to print for different report types You can also nate 1 Report Output specify if report should be printed jointly Specify settings press OK when finished to save and exit Report Output Specify optional data to print for different report types Yon can also specify if report should be printed jointly Report Type Time Abs Cone Interop Note Calibration By Request Time By Mames 1D By Test By Interpretation To 2131313131 414141414 4151514177 56 138 Human Elisys Uno User Manual 5 2 Start of Day Running Start of Day at the beginning of every workday is recommended 5 2 1 Run Start of Day Check the bottle volume levels empty the Waste bottle if necessary empty the Prime bottle and refill it with fresh deionised water Start of Day Procedure From the Routines Menu Select Start of Day Routines Lot R Start of Day End of Day Wash Probe Prime Syringes Prime Washer Prime Rinse Temperature On Temperature OFF Filter Voltages Read Wells Custom Script
96. n has passed If running the Self Test yields poor results attempt the following steps 1 If small 2ul CV results are within specifications but medium 10ul and large 18ul are out of range failure is likely not with pipetting accuracy but rather with photometer plate positioning N If small 2ul CV results are not within specifications check the following e Check for diluter system leaks e Check syringes for freedom of movement e Check that probe tip is not partially bent e Rerun channel blanks e Recheck photometer alignment If this is adjusted check plate X Y parms e Recheck probe alignments Note is temperature sensitive Make sure the instrument temperature is set to OFF and the temperature has stabilized irritates eyes skin and mucous membranes Upon contact rinse thoroughly with copious amounts of water and consult a doctor Launch Assay Editor Human gt Diagnostics Worldwide 47 138 The Assay Editor will open when the Launch Assay Editor option is selected from the Help Menu Refer to the Assay Editor in Section 6 for more information Settings Security Help Self Test Launch Assay Editor Launch Pack Waste bottle E aste bottle r p m 4 4 8 2 Launch Pack The Pack application is used by technical support to troubleshoot problems Type in a description of the problem before packing the data Pack Unpack a certain files to do migration Pack Unpack all root file
97. nition Section 7 1 1 ELISA Specific Modes 7 1 1 1 Cut Off Mode Within the cut off mode ELISYS UNO offers four 4 equations to choose from Assay Mode Cut Of Formula Lov mean Nc mean Pc F gt Corse mean Ne F Low mean Pe F Cov s mean Nct rt mean PelF Covw mean Cc F Figure 7 1 1 1 Cut Off Mode Equation Choices COV X mean CC F Cut Off Control COV cut off value for positive or negative interpretation X a variable provided in the Assay Kit package insert NOTE X will equal 1 if no value of variable provided mCC the calculated mean of the absorbance values of the cut off controls when test is run Blanking is optional dependent upon the Assay Kit F factor added to the mCC If needed this value is provided in the Assay Kit package insert If none provided use zero for the value of F Positive and or negative controls may be used for OC criteria 112 138 Human Elisys Uno User Manual Assay Mode Cut OF Formula Lov mean Cc F al X 1 000 F 0 000 Figure 7 1 1 2 Cut Off Control Mode COV X mean NC Y mean PC F Use this equation when ELISYS UNO must calculate the cut off value based upon readings or positive and or negative controls In this equation NC and PC are used to determine the COV cut off value Enter the variables provided in the package insert ELISYS UNO calculates the mean of the positives and the mean of the negatives
98. obulin MisFix AA B 2 Microglobulin MixF ig A B 2 Microglobulin WF fi MixFi No Curve i No Curve No Curve No Curve A CMY IgG Dias orin No Curve A CRP A CRP BioCheck No Curve AA CRP BioCheck MixFix No Curve AS A CAP BioCheckL No Curve AA CRP dilutiontest No Curve Add Sample ID Remove mamm Incomplete Expired Incomplete Incomplete Incomplete Incomplete Add Numerical ID Note Prefix R will be automatically used to differenciate numerical ID with sample ID First ID pc Incomplete Total Invalidated Abnormal Expired No Curve Invalidated Incomplete Incomplete Incomplete Incomplete Incomplete Incomplete Incomplete Expired eee Figure 5 3 1 Sample tab No items to show lt Select all Press Add Numerical ID Type in the First ID and the total number of patients refer to Section 4 3 3 Sample Tab Click OK to add the IDs Refer to Figure 5 3 2 Assigned Assays and click on each patient s and add tests for them to the Work List After pressing Request the Layout tab opens Use loading positions to correctly load the racks refer to Figure 5 3 3 Layout Tab with Load Positions NOTE Press Add Sample ID to access IDs from the Sample Database 70 138 Human Elisys Uno User Manual it Elisys Uno EIA Mode Management Routines Lot R
99. oftware Pauses the process that your ELISYS UNO is doing at that time Resume allows ELISYS UNO to resume the previous task from the point it paused Use this feature after editing or creating new assays with Assay Editor The new or edited assays are then added to the list of available assays in ELISYS UNO Manager Not available Change the temperature for specific tests For instance when running the Performance Check change to Room Temperature Change the rack style Not available Used when running a plate that contains long incubation times Other tests even entirely different modes can be run by loading a different plate There is a reminder to reload the plates when time is almost expired Used for Service Purposes ONLY See Section 5 2 4 Calibrators for more information Read the information that follows this table explaining the LIS Import Option and examples of import and export files Exit the ELISYS UNO Manager Software Human Do mo Diagnostics Worldwide 39 138 4 4 1 1 Laboratory Information System LIS The ELISYS UNO Laboratory Information System LIS provides a method or protocol to allow for ease of information exchange between two systems The patient information from external sources can be easily uploaded into our patient database This database will contain patient information and tests requested Upon job completion the patient information and assay results can be downloaded into a text file
100. og of every user name that has logged on including a time and date stamp and a running count of entries 18 138 Human Elisys Uno User Manual 4 2 Alignment Setup Before running any tests or jobs the instrument must be aligned and setup Use the procedures in this section to ensure that the ELISYS UNO is ready to work When the software is first opened a prompt will ask if the ELISYS UNO has a washer If no select No and again at confirmation 4 2 1 Alignment Under the Settings menu select J Alignment Settings Security Help Probe vs Rackl Software Probe ws Rack2 Custom Report E Probe vs Plate fe _ eee Probe vs Wash Cup Washer vs Plate Rack Dispense Height Channel Blank Display Instrument Parameters Restore Instrument Parameters Figure 4 2 1 1 Settings gt Alignment Menu Select Probe vs Rack1 Probe vs Rack x Figure 4 2 1 2 Adjust Probe Position for Rack1 To check the current alignment lick th click the probe button a Human gt Diagnostics Worldwide 19 138 Alignment Continued Use the arrow buttons to position the probe correctly The probe tip should be centered about 3mm above the rear pin as shown Side to Side blue a Forward and Backward Up and Down red green To check new alignment select Test When finished click Save then click Close Next select Probe vs Rack 2 from t
101. on to dilute in the sample rack and clean rinse after dilution 4 Press OK or click the Advanced button for Advanced Parameters such as aspiration speed air gap dispense speed dispense height NOTE Dilution ratios and total volume being specified must result in a Sample volume of greater than 2uL Predilute Parameters Main settings Dilution Ratio le 25 Total Volume 50 0 Sample LT Diluent Volume 20 pL Advanced Mang pet Change phate Set the volumes manually Volume 40 1 uL i Dilute to plate Instead of sample rack Advanced Aspiration settings What should be diluted in addition to samples Aspirate Separately e cio Separation Air Pocket F Dilute Controls Dilution in sample rack Cancel Figure 6 3 1 1 2 Pre dilute Parameters Human gt Diagnostics Worldwide 89 138 Predilute Parameters E Main sethings Dilution Ratio 1 25 Total Volume 50 0 sample Diluent Volurne ae Clean Rinse Probe steps after Dilution A ATE Add Clean Frobe Add Rinse Probe Set the volume Dilute to plate Advanced Aspirati ion to samples 5 tion Air F eparation Ar Foc Edit Step q 4 Delete Step cos Mix by Aspirate Dispense Predilution Incubation Time E Clean Rinze after Dilution Cancel OK Figure 6 3 1 1 3 Clean step after dilution 00 00 00 Advanced Parameters x _ __ Aspiration Speed
102. or Message is Probe Z axis is jammed 9 1 1 Flags Possible Insufficient Aspiration This flag may appear If incorrect bottle sizes are used in the reagent rack If reagent bottles are filled past the neck Volume Calculation ELISYS UNO automatically detects liquid surfaces and makes approximate volume calculations based upon the diameters of the rack cut outs and the distance between the detected surface and the bottom of the rack Hanging containers that do not rest on the bottom of the rack will introduce error to the volume approximation if the container bottom level is not set to a new value These types of containers can only be used provided the new container bottom level is properly set using Rack 2 setup see Section 4 2 Instrument Setup A CAUTION Conical containers and containers narrower than the rack openings will always result in volume calculation errors Flags Continued Possible Insufficient Aspiration Continued Probe Insertion Depth For reagents it is important to choose straight walled bottles that snugly fit the rack hole cut outs Refer to Figure 9 1 1 1 Probe Insertion Depth Illustration Sample volumes are usually so small that the vessel configuration is not a factor Reagent handling however can be adversely affected by significantly tapered or under sized vessels This is why the probe detects the liquid surface at the start then ELISYS UNO calculates the proper insertion depth for t
103. ort settings For the Instrument with Washer At this time the wash arm is raised from its shipping position Install the wash head found in the accessories carton to the wash arm using the two attached thumbscrews The luer fittings must face outward toward the user and the colour coded fittings on the tubing should be fastened finger tight to the wash head Refer to Figure 2 2 1 Wash Head Installation Figure 2 2 1 Wash Head Installation Human gt ae Diagnostics Worldwide 11 138 12 138 Human Elisys Uno User Manual 3 Principles and Specifications The syringe pump is used to make precise dilutions The syringe measures volumes of 2 5 ml or less The single probe moves left and right as well as vertically It is equipped with a liquid surface detection mechanism that stops the probe automatically when the tip is sufficiently submerged Probe washing uses de ionised H2O from the prime bottle and drains to the bottle below Each of the two racks and the plate move independently toward the front and back of the instrument Commonly referred to as a reagent rack a Sample rack and a Reaction plate However reagents can be placed in the Sample rack or two racks can be used to perform pre dilutions Each rack has an arrangement of holes or grooves configured to hold different types of tubes bottles micro tubes microwells and other containers Racks are identified in the software in order to tell the instrument which configura
104. permanent drain CAUTION Do not allow the end of the tubing to rest in the drain container below the expected level of the waste liquid 3 Match the colour coded connectors on the three bottle cap assemblies to the coloured connectors on the right side of the instrument Turn each connector about 1 4 turn clockwise to lock it in place Insert the sensor cable jacks matching the coloured tie wrap with the colour coded connectors Figure 2 1 1 Connectors CAUTION The hydrophobic filter on the waste bottle is designed to protect the pump from liquid and may become clogged when wet Arrange the tubing so that the filter hangs down below the connecter on the side of the ELISYS UNO to prevent clogging Human s e Diagnostics Worldwide 7 138 4 Put de ionised water into the bottle marked Rinse Put wash buffer provided into the bottle marked Wash for ELISA tests Leave the Waste bottle empty Check that each bottle cap is securely fastened and that no sensor wires are crossed Note that the Waste bottle has short sensor leads in order to detect when waste is nearly full Rinse and Wash bottles have long leads in order to sense when bottles are nearly empty 5 Fill the Prime bottle with fresh clean de lonised water This should be done each day this water enters the precision calibrated syringe pump and therefore must be very pure to avoid damage and prolong the life of these components Prime bottle installed as shown in Figure 2 1 2
105. ppears look for a physical obstruction to remove and verify correct instrument set up alignments 007 Probe X axis is jammed Make sure the probe is properly seated with the retention hook over the collar 008 Rack 1 is jammed Possible causes are bottles that are too tall or have too small of a diameter for the rack cut out 009 Rack 2 is jammed Make sure bottle caps have been removed correct rack files are being used and the setup alignment parameters including probe depth and wash head depth are correct Human SP ae Diagnostics Worldwide 133 138 Error Code s Problem Rack is jammed Continued 010 Diluter not acknowledging 011 CSI O Inactive 013 Timeout waiting for coprocessor message 014 Diluter not responding 015 Timeout waiting for completion of last coprocessor command 016 Check reagent sample level 018 Probe sensor malfunction 019 Parameter checksum error 020 Probe jammed while trying to detect the liquid surface 134 138 Human Elisys Uno User Manual Solution If normal operation does not resume after clearing the obstruction select Initialize from the Management tab on the ELISYS UNO Manager menu If the problem is not solved by re initializing make a service report Turn the instrument off and restart it If the jam has not cleared send the service report NOTE The service report should be made BEFORE restarting the software so that important information will not be lost Check the ca
106. product and certified for the country of use Ground the Product This product is grounded through the grounding conductor of the power cord To avoid electric shock the grounding conductor must be connected to earth ground An optional method is to attach a ground strap from the external grounding terminal on the rear panel of the instrument to a suitable ground such as a grounded pipe or some metal surface to earth ground Observe All Terminal Ratings To avoid fire or shock hazard observe all ratings and markings on the instrument Consult this manual for further ratings information before making connections to the instrument Install as Directed Install the instrument on a sturdy level surface capable of safely supporting the instrument s weight 45 kg The mounting surface should be free of vibrations The instrument does not require fastening to the bench top Provide Proper Ventilation Refer to the installation instructions for details on installing the product so it has proper ventilation The instrument should be surrounded by the following clearances 46cm on each side 117cm on top 15cm in front and 18cm in back Do Not Operate Without Protective Covers Do not operate this instrument with covers and panels removed Do Not Operate Without Probe Shield Do not operate this instrument with shield removed Doing so risks the operator to biohazard injury from the probe Use Proper Fuse Use only the fuse type and rating specified by
107. r The following information is Enzyme Immuno Assay ELISA testing specific 7 1 Assay Editor and ELISAs E GEST Editor Assay View Substances Panels Indices Securty Settings Help o y y ee ee SS OA N CHEM Y EIA mj AS Cti Std Assay Name New Assay El Assay Mode Type ElA I Flat bottom wells Absorbance Absorbance Temperature Room Temp a E Cut Off Cut Off Standard Point to Font Linear Regression Cubic Spline Constrained Dose Response Assay Description A B B Figure 7 1 1 Assay Definition Menu 1 Assay Name Enter a name for the new Assay 2 Type Indicates that an ELISA Assay is being programmed 3 Flat bottom wells if not checked single final aspirate from the centre of the well will occur during programmed well wash steps Check box for Flat bottom wells or side to side aspiration double aspiration 4 Temperature Room Temperature 370 or 250 selection 5 Assay Description Entering a description for the Assay is optional However a short description of the edited or newly created Assay is recommended 6 Assay Mode There are ten 10 ELISA Modes available Those specific to running ELISAs are described below Human gt Diagnostics Worldwide 111 138 Assay Mode Absorbance Y Absorbance Cut OFF Cut Off Standard Point to Point Linear Regression Cubic Spline Constrained Dose Response ind Figure 7 1 2 Assay Mode Defi
108. r the self test completes the instrument displays Pass Fail results on the screen Clicking the Details button will display the complete self test report The screen will track the progress of the test Self Test Pleaze load NaDH Diluent in Rack7 1 PNP in Rack2 1 and make sure the plate is empty Then click Start button to run Lag i LE Self Test PASSED 0000000000008 HOCH CCReOCBGOr RRpRoooooooDooO Pipetting Accuracy Small Sample OR Medium Sample OF Large Sample OK PhotometerPlate Positioning PASSED Test Progress EERE See eee staile Close 46 138 Human Elisys Uno User Manual Pressing the Details button once the Self Test is completed will open the Self Test log in Notepad The Self Test log in Notepad displays the date time status of Lamps Blank Pipetting Accuracy Photometer Plate Positioning Temperature Blank Abs Filter Volts etc P SelfTest4 log Notepad File Edit Format View Help Friday October 07 2005 09 18 Lamps OK Blank OK Pipetting Accuracy Small Sample OK Medium Sample OK Large Sample OK Photometer Plate Positioning PASSED DETAILS 6 2 0 43 1044 0 9110 90 Temperature at start 22 5 C Temperature at end 22 6 C Blank Abs 0 0003 Filter Wolts 700 340 630 600 545 505 450 405 Channel 2 9300 2 3850 5 0830 6 2150 4 9740 4 8870 5 7030 4 5580 Channel2 2 4330 2 2830 4 1930 5 1640 41460 41150 4 9890 41530 Channels 2 3680 2 1080 4
109. read steps in assays All filter wavelengths are in nanometers nm Filters installed on recently connected analyzer FOU 340 630 EDO 045 505 450 405 Use these Special filters Use when programming assays for an analyzer with different filters C Use these YOO 340 630 600 545 505 450 405 cancel Figure 6 1 7 3 Installed Filters may vary 82 138 Human Elisys Uno User Manual 6 1 8 Icons To see the function each icon has place the mouse cursor over the icon in Assay Editor A description will appear ae Create a new ELISA Assay ay EIA Open an existing ELISA Assay Save Saves the current Assay under the name entered in the Assay Definition Section See Section 6 2 for more information ALS Save As Allows the Assay to be saved under a different name or to save another copy of the Assay Print Assay Prints the current Assay gt Manage Reagents Same function as selecting Reagents under the Substances menu See Section 6 1 3 for details Ctr Manage Controls Same function as selecting Controls under the Substances menu See Section 6 1 3 for details on 3 Manage Standards Same function as selecting Standards under the Substances menu See Section 6 1 3 for details Y Help Opens the Help window See Section 6 1 8 for details Human gt Diagnostics Worldwide 83 138 6 2 Creat
110. robe Position for Plate To check the current alignment lick th be button click the probe button a Use the arrows to move the probe The probe tip should be centred in well HO1 and almost into the correct position touching the bottom Press Test to confirm When finished click Save and then the Close button 22 138 Human Elisys Uno User Manual Alignment Continued Select Probe vs Wash Cup from the menu Press the aT button The probe will move to the centre wash position and lower into the cup The probe tip should be centred in and at the surface of the small centre wash cup If it is not in position use the arrow keys to move the probe into position Settings Security Help Software Probe vs Rackl Probe vs Rack2 Custom Report Probe ys Plate 11 2 III I ION Probe vs Wash Cup Washer vs Plate Rack2 Dispense Height Channel Blank Display Instrument Parameters Restore Instrument Parameters Figure 4 2 1 1 Settings gt Alignment Menu Probe ys Wash Cup E ox eel e 2 a Please watt Figure 4 2 1 5 Adjust Probe Position with Wash Cup When finished click Test to check new alignment If aligned click Save then Close Choose Washer vs Plate from the menu Software Settings Security Help Probe vs Rackl Probe vs Rack2 Probe vs Plate Alignment j
111. s ola 1000 uL Humber of times 1 So Enables Rinse Probe Human gt Diagnostics Worldwide 95 138 6 3 2 Edit Step Edit Step Select the Edit Step button to Assay Prescription change settings in an existing step ee Assay Sheps Edit Step Delete Step Copy Step Limits Conc j or one 6 3 3 Arrow Buttons Arrow Buttons _ SS See oe Assap Sheps Edit Step Delete Step Copy Step Select a step in the list to the right and use the arrows to move that step higher or lower in the sequence 96 138 Human Elisys Uno User Manual 6 3 4 Delete Step Delete Step SS Se r Azay Description Assay Sheps me Edit Step 1 xs Delete Step Copy Step Select a step from the list on the right and click Delete Step to remove it from the list 6 3 5 Copy Step Copy Step _ See oe noo Select the Copy Step button to copy an existing step Assay Steps Edit Step Delete Step Copy Step Units Cone A pane eg fee a Human gt Diagnostics Worldwide 97 138 6 4 Interpretation Settings Interpretation Settings Units e E Posit mg dL Normal Range Positives Negative of Decimals Pos gt 1 ka Meg z Special Groups Reversed Figure 6 4 1 Interpretation Settings 1 Units Use this drop
112. s Abs SD 0 003 Conc SD 1 347 C Name Name Normal Control Conc 99 10 Abs CV 1 630 Conc XEY 1 704 Abs Mean fo 67 Conc Mean ra 060 Time 07712704 11 15 50 07412204 11 15 50 07412204 11 15 50 07712704 11 15 50 07412204 11 15 50 07412204 11 15 50 07412204 11 15 50 07712704 11 15 50 07412204 11 15 50 07712704 11 15 50 07712704 11 15 50 07412204 11 15 50 07712704 11 15 50 07412204 11 15 50 07712704 11 15 50 Concentration 8 QC Points Print QC Report By absorbance By concentration Figure 4 4 4 2 OC Tracking Example Enter the assay control and lot number information in the drop down menus to select the control that you wish to review Human gt Diagnostics Worldwide 43 138 Points can be edited and data can be printed from this screen Lot numbers are entered in the tab labelled Lot Registration In Figure 4 4 4 3 Edited OC Report three low points 11 12 and 13 have been removed from the curve displayed in Figure 4 4 4 2 OC Tracking Example Make sure to select Save The new curve is shown below QC Tracking Ed 1 Search by Assay C Name QC Title 2 Choose an assay QC Glucose y Assay QC Glucose Name Normal Control Lot 027302 Abs Conc 99 10 3 Choose a name Normal Control 4 Choose a Lott foz y 27300 Abs Mean Jo 66 Abs SD fo 002 Abs ZEY fi Eme Conc Mean 78 600 Con
113. s 0 389 Abs 0 495 Abs Resume 4ll 1 2 WU seme 1 7 WUmL 1 8 plU mL 1 3 plU mL 2 5 plU mL 0 7 plUtmL 2 0 wWlU Ame 4 0 plU mbL 1 7 WUmL 2 3 plUtmL LUGS ooo OO 000 000 000 000 000 miss woe JHE al Report Figure 8 2 7 TSH Results In Figure 8 2 8 TSH Curve 10 Factor below the calibration curve is adjusted by 10 Factor adjustments occur immediately and do not require clicking on the Activate Selected button Y Add calibration test v Show backup Work list Interpretation TSH Incomplete Abnormal Curve recent white current blue backup gray Control current pink Criteria Absorbance Concentration The curve based on selected records oo oo oo oo No Data Absorbance Soo ooo o oO oooO Oooo o0o0oo D 0 0 0 0 0 0 0 0 0 0 00 0 0 00 0 0 The current curve Nm F O O Absorbance sia ra o o Pq i Save Request Ditcatd Recent Print Preview Print Report Factor 0 7 Load gt Calibration 2 Sample TH Test List 2 Report Figure 8 2 8 TSH Curve 10 Factor The new concentration values are displayed in the Sample Tab as shown below in Figure 8 2 9 TSH Results 126 138 Human Elisys Uno User Manual Highlight By Name ID Highlight By Assay 7 Current Step None Name ID Assay TimeLeft Absorbance Concentration Interpretation
114. s added to the well The pre warm time can be set up to 59 minutes and 59 seconds Dispense Speed The acceptable range is 0 to 4 The fastest speed is 4 Default speed is 2 Dispense Height There are two levels of dispensing High or Low The default is Low for a Sample and High for a reagent 63 13 Incubate Lag Time Incubate Step Parameters x Time To Incubate oo 00 Cancel Figure 6 3 1 3 1 Incubate Step Parameters Reference Figure 6 3 1 3 1 Incubate Step Parameters Enables an incubation lag time in hh mm ss format where hh hours mm minutes ss seconds NOTE For Rate Mode test this is where the lag time is set Human gt Diagnostics Worldwide 93 138 6 3 1 4 Read NOTE If using a differential blank or sample a Read step must be added both before and after the Incubation step Read Step Parameters Read Step Parameters xX Primary Filter 405 Y Differential Filter 530 Cancel Primary Filter Select a primary filter to be used for readings There is no default value A primary filter must be selected before continuing Differential Filter Select a differential filter that should be used for readings if any There is no default value One of the options from the list must be selected to continue One of the options is None The differential filter cannot be the same as the primary filter NOTE A differential filter should always be used if at all possible when running a
115. s for touble shooting Direction e Pack Action Pack ROOT files y C Unpack To pek file From root folder some R6SRoot Content de File Name F dbPatient mdb M dbTest mdb Y Other root files 7 Select all Progress Select Pack options from the drop down menu Options include packing assay files root files lot files and rack files An individual file may be selected by clicking in the check box next to the file name or all files may be selected by clicking on the Select all checkbox ion PackUnpack all root files for touble shooting ler EN Whe RESA oot Fack ASSAY files Fack ROOT files Pack ASSAT files Pack LOTE files Pack RACK files 48 138 Human Elisys Uno User Manual Pack Pack Unpack a certain files to do migration Pack Unpack all root files for touble shooting m Direction f Pack C Unpack From root folder Action To pck file e REMBootilab_assay pck Content ope POUT description File Name e VWassayelhem Example 4esays E sample W VesayeChemExample Assays E sample VaesayeChem Example Assays Example WWesayslhem Example AssaysE sample Weeayslhem Example Assays sample Wesayslhem Example Assays sample WesayslhemsExample A4esaps Example VWoesaysChem Example Assays Example Weave hem Example Assays FE sample Wesayslhem Example Assays sample Wesayslhem Example 4ezap Example WA sol bare Diana la Aaa seh Daneel 414 aaa aaa
116. s include setting the washer depth too low or setting it such that the wash head tubes hit the edge of the reaction plate wells See Instrument Set Up The Set Up should be re checked so that the long tubes of the wash head just lightly touch the microwells and are set toward the back of the centre of the wells Make sure that the wash head appears level after installation and that the screws are snug Check for physical jams blocking the path of the wash head Human SP ae Diagnostics Worldwide 135 138 Error Code s Problem Solution 512 Waste bottle is full Pause the Engine by clicking on the Pause Engine icon il Pausejresume Engine Click on icon again when finished to Resume Engine Carefully unscrew the cap and empty the waste bottle A CAUTION Protect yourself from contact with hazardous waste Make sure the aerosol filter does not get wet in the process replace ifthis happens If the Waste bottle is already empty when the error message is observed check that the sensors are not shorted by foam or touching each other Clean the inside of the cap with a paper towel Close the cap tightly and assure that the coloured luer locks and sensor are plugged in before resuming operation 513 Wash bottle is empty Wash Rinse bottles are low The instrument detected an empty condition on the wash or rinse bottle If the bottle is full check that the sensor s lead is securely connected to the bottle cap and pl
117. s of commands Recommended for advanced users 4 4 3 Lot Registration Refer to Section 5 2 3 Calibrators for more information 44 4 QC Tracking Enables Controls and Calibrators to be tracked using a Levy Jennings chart In past versions OC tracking could be accessed at the assay level through the QC tab With ELISYS UNO this feature is accessed by selecting OC Tracking from OC on the main menu QC Tracking 1 Search by 2 Choose an assay 3 Choose a name 4 Choose a Lot 5 Edit QC points Index Abs e Assay QC Title Assay C Name Lot Abs Mean fo 000 Conc Mean o 000 Abs Abs SD 0 000 Conc SD 0 000 Conc Abs ZC o 000 Cone ZCW 10 000 No items to show lt MT No points to show Select QC points Save GC points Assay foc Glucose y Normal Control x 027302 QC Tracking 1 Search by 2 Choose an assay 3 Choose a name 4 Choose a Lot 5 Edit OC points Abs Cone Abs 76 6 mg dL Abs 77 6 mg dL Abs 78 0 mg dL Abs 79 5 ma dL Abs 79 0 mg dL Abs 79 0 mg dL Abs 80 4 mg dL Abs 79 0 ma dL Abs 79 5 ma dL Abs 77 6 mg dL Abs 81 4 ma dL Abs 80 4 mg dL Abs 80 9 mg dL Abs 79 0 mg dL Abs 78 0 mg dL ee M Select QC points Saye Wis pants By absorbance Print OC Report By concentration Figure 4 4 4 1 OC Tracking Menu Page x OC Title Assay OC Glucose Lot 027302 Ab
118. sh bottle Select Resume Engine from the Management Menu Waste Bottle Full When the waste bottle becomes full during a run the software will prompt Waste Bottle Full If the message appears to be in error wipe out the inside of the bottle cap with a dry cloth It is very important not to run the instrument when the Waste bottle is full to avoid damage The software does not check the drain waste container NOTE Although the software only checks the Wash Rinse and Waste bottles when necessary for assays the instrument checks itself periodically If the instrument is beeping periodically during periods of inactivity check the bottle volume levels 132 138 Human Elisys Uno User Manual O12 Error Messages Error Code s Problem Solution 001 Unknown Command Check command for spelling and validity 002 Parameter exceeds allowed range 003 Too few or wrong parameters 004 Command has not been implemented 005 Fluid not detected in range Add more fluid to the container and press Resume All Not enough Sample or Reagent When setting up a run be sure to have about 100 ul of extra volume in each serum vial It is also important to place more reagent volume in the reagent bottles than is actually necessary in the assay If the reagent volume is limited the reagent bottle position should be assigned in the assay or in the run to use one of the smaller rack positions 006 Probe Z axis is jammed When a jam message a
119. ssays in ELISYS UNO Some assay inserts do not specify to use a differential filter but when running assays in microplates as in ELISYS UNO a differential reading filter usually improves results It is important to choose a differential wavelength which is at an absorbance minimum in the absorbance spectrum of your reacted reagent If your assay insert does not specify a differential wavelength to use for your reagent and there is no corresponding ELISYS UNO example to use contact the reagent manufacturer for the best wavelength choice 94 138 Human Elisys Uno User Manual 6 3 1 5 Clean Probe The Clean Probe step aspirates the cleanser from the bottle in the rack and dispenses it to waste This is a special step for cleaning the probe with acid bleach or other special cleanser Clean Probe Parameters cea Choose or create cleanser eae Denpi MIN HCI OS Albumin Reagent M i Phos Reagent Eee Assay Sheps MALT Reagent BUM AT Edit Step EUN Re M EUN Reagent ate SE M Calcium 42 Ill Reagent Calcium Butter Reagent i Delete Step O Calcium CPC Reagent NW Chloride Reagent _ Copy Step Cholesterol Reagent MA Creatinine Buffer A1 Creatinine Picric A1 Creatinine R2 Creatinine working iret Rilirnihin 101 I Volume Desired cleanser volume to be aspirated by the probe 6 3 1 6 Rinse Probe Rinse Probe Step Parameters Rinse Probe Step Parameter
120. t r62 val 0 0008 d4 amp bs 60sec 110 0 mg dL 11 3 High High z 9 23 05 3 07 41 PM Example ALT 0 0003 d amp bs min 1 UAL Low Y R 4 M 9 23 05 3 07 41 PM Creat 162 val 0 0008 d4bs 60sec 10 0 mg dl High M 9 23 05 3 07 41 PM Creat r62 val 0 0005 d amp bs 60sec 16 3 mg dL 7 5 High High E 9 23 05 3 07 41 PM Example 4LT 0 0005 d amp bs min 2 UAL Low Y R5 M 9 23 05 3 07 41 PM t r62 val 0 0014 d bs 60sec_ 17 5 m High M 9 23 05 3 07 41 PM t r62 val 0 0009 d bs 60sec 111 2 na 15 0 High High 4 9 23 05 3 07 41 PM ample ALT 0 0001 d amp bs min ou Low IV A 6 M 9 23 05 3 07 41 PM Creat r62 val 0 0009 d4bs 60sec 94 2 mg dl High Dut LA R M_9 23 05 3 07 41 PM Creat val 4 0021 d amp hs ANsec 125 0 moe Hinh A Retest V Select all TT Fold all Sort by Name ID x Print Preview Export ji Layout Calibration f Report Ready e 4 Figure 4 3 5 1 Report Tab By default the Report tab shows the information from the most recent test run In Figure 4 3 5 1 Report Tab the Report Tab shown is displaying information after running the Example Albumin Calibration in Section 5 2 3 Calibrators Results are organised based on the time they are run Select all or individual tests using the checkboxes for printing 1 Select Sorting option from drop down menu to change the way your results are displayed 2 Select the History checkbox to begin searching for results by date substance type name
121. the box next to Blank Used Figure 6 7 1 Blank Properties Set up the Absorbance Range Out of Range Action and the Valid Time for the Blank Figure 6 7 2 Properties ES Absorbance Range 4 From To Action to take when result i out of range farm and Continue am and Continue nvalidate Tests Valid Time 7 Dalel O Hours cae Figure 6 7 2 Blank Properties Absorbance range Expected absorbance range of the blank Action to take when result is out of range 1 Warn and Continue Continue the test when absorbance is out of the range but put a warning to the report 2 Invalidate Tests Invalidate the Assay results Valid Time Blank result valid time in days and hours Default value is 7 days 106 138 Human Elisys Uno User Manual 6 8 Controls Figure 6 8 1 Controls Menu Controls are used to validate tests see Figure 6 8 1 Assay editor has two controls predefined Normal Contro and Abnormal Control New controls can be defined if needed 1 Add Select an existing Control or create a new one Select a Control or define a new one t x BB Abnormal Control half PNP WW Large Sample Lipid Level 1 W Lipid Level 2 Medium Sample new test abnormal M Normal Control Quarter PNP E Small Sample TSH Abnormal COntrol EE TSH normal control Figure 6 8 2 Select or Create Controls 2 Properties Control Properties xj Name
122. the manufacturer for this instrument Avoid Exposed Circuitry Do not touch exposed connections and components when power is present Avoid Excessive Dust Do not operate in an area with excessive dust Do Not Operate With Suspected Failures If you suspect there is damage to this instrument have it inspected by a qualified service person Do Not Operate in Wet Damp Conditions Do Not Operate In An Explosive Atmosphere Keep Instrument Surfaces Clean and Dry Solvents such as acetone or thinner will damage the instrument Do not use solvents to clean the unit Avoid abrasive cleaners the aerosol shield is liquid resistant but easily scratched Clean the exterior of the instrument with a soft cloth using plain water If needed a mild all purpose or Human gt as Diagnostics Worldwide 3 138 nonabrasive cleaner may be used Use as a disinfectant a 10 solution of chlorine bleach 5 25 Sodium Hypochlorite or 70 isopropyl alcohol Take special care not to spill liquid inside the instrument 4 138 Human Elisys Uno User Manual 1 4 Operating Precautions WARNING Insufficient RAM will adversely affect the performance of your instrument Therefore if using Windows ME the minimum RAM required is 96 MB For Windows XP the minimum RAM required is 128 MB Watch the instrument during Start of Day operation to ensure that the probe and wash head dispense functions are operating properly Be sure to run a sufficient number of controls
123. this warranty if the product is not used in accordance with the manufacturer s instructions altered in any way not specified by HUMAN not regularly maintained used with equipment not approved by HUMAN or used for purposes for which it was not designed HUMAN shall be relieved of any obligation under this warranty unless a completed installation warranty registration form is received by HUMAN within 15 days of installation of this product This warranty does not apply to damages incurred in shipment of goods Any damage so incurred shall be re ported to the freight carrier for settlement or claim 3 INTENDED USE OF THE INSTRUMENT The instrument has to be used for the expected purposes and in perfect technical conditions by qualified personnel in working conditions and maintenance operations as described in this manual according to the GENERAL SAFETY WARNINGS This manual contains instructions for professional qualified operators 4 GENERAL SAFETY WARNINGS Use only chemical reagents and accessories specified and supplied by HUMAN and or mentioned in this manual Place the product so that it has proper ventilation The instrument should be installed on a stationary flat working surface free from vibrations Do not operate in area with excessive dust Work at room temperature and humidity according to the specifications listed in this manual Do not operate this instrument with covers and panels removed Only use the power cord specified
124. tion is to be used They are also displayed graphically The incubator plate well can be set to heat to 25 C 37 C or remain at ambient room temperature The plate well will heat to 25 C providing the ambient room temperature is below 25 C It should be noted that the option of heating the plate well to 25 C should only be used when the ambient room temperature is consistently below 20 C When the probe carries a reagent to an incubated reaction plate the temperature controlled coil can be set to pre warm the liquid before dispensing Reagent racks can be loaded and unloaded with bottles from run to run The location of each reagent is indicated using a colour coded computer screen Alternately preferred reagent rack setups can be stored in panels For convenience multiple pre loaded racks can be stored in the refrigerator ready to load and use When taking an optical reading the reaction plate automatically positions itself under the 4 channel optical system Four lamps are aligned to simultaneously shine down through four wells A filter wheel with eight filters rotates constantly below the plate The filter wheel is designed so that four filters align with the four lit wells for absorbance readings Depending on the setup reports may be displayed or printed to create permanent lab records and physician reports Human gt e Diagnostics Worldwide 13 138 3 1 Technical Specifications Overall 86cm W x 51cm Lx 40cm H
125. to Wash Management Routines Lot Registre Initialize Pause Engine Ctrl F 1 Pause Probe atit Reload Assay Files Switch to EIA Mode Change Temperature Change Racki Auto Wash Plate Multi plate Test Communication Window FS Calibration Event Fa LIS Import Exit Figure 5 1 1 1 Management Menu If your ELISYS UNO has a plate washer you may choose Auto Wash Plate shown here as it appears with no plate washer from the Management Menu Activating this option will allow the instrument to automatically wash the plate when finished with tests Human ss ee Diagnostics Worldwide 51 138 5 1 2 Software Settings Choose Software under the Settings menu Figure 5 1 2 1 Selected Database Option Software Settings oa g y dos ELS Strategy a l Report Appearance 12 Report Output Figure 5 1 2 2 Software Settings You may choose to keep the records of numerical ID records from 1 to 10 years choose to keep sample IDs from 1 to 30 days However whatever preferences you choose all sample test records are backed up monthly to an archive database The communication port can be changed The default temperatures are displayed for ELISA mode Press OK when finished 52 138 Human Elisys Uno User Manual Dialed 0d Sample Database Software Settings Continued OPTION DESCRIPTION Customize sample database field names uncheck field name from the E T Sample Database list displayed if yo
126. ts Batteries power packs and similar power source have to be dismounted from electric electronic parts and disposed off in accordance with applicable local regulations 6 INSTRUMENT DISINFECTION Analytical instruments for in vitro diagnostic involve the handling of human samples and controls which should be considered at least potentially infectious Therefore every part and accessory of the respective instrument which may have come into contact with such samples must equally be considered as potentially infectious Before doing any servicing on the instrument it is very important to thoroughly disinfect all possibly contaminated parts Before the instrument is removed from the laboratory for disposal or servicing it must be decontaminated disinfected Decontamination disinfection should be performed by a authorised well trained personnel observing all necessary safety precautions Instruments to be returned have to be accompanied by a disinfection certificate completed by the responsible laboratory manager If a disinfection certificate is not supplied the returning laboratory will be responsible for charges resulting from non acceptance of the instrument by the servicing centre or from authority s interventions 7 NOTICE Every effort has been made to avoid errors in text and diagrams however HUMAN GmbH assumes no responsibility for any errors which may appear in this publication It is the policy of HUMAN GmbH to improve products as new te
127. tubing remains pinched move the tubing so that a different area gets pinched Open the tubing by stretching it and rolling it between your fingers If the aerosol filter on the waste bottle gets wet it will no longer function try changing this filter assembly To prevent accidental flooding of the plate during washing the ELISYS UNO automatically verifies adequate aspiration before beginning a wash cycle by moving down and blocking the aspiration probes against a foam test strip If the foam is worn away or if the wash head is not level air may leak into the system and cause this message Check that the wash head is properly installed Check the wash head alignment setting the wash head height to a lower setting usually solves this problem see Section 4 2 Instrument Setup Check that all tubing is connected and not pinched If this does not solve the problem replace the foam strip Check for obstruction in the head or tubing A clogged aerosol filter may also be the cause try replacing this assembly Human SP e Diagnostics Worldwide 137 138 Error Code s Problem Solution 520 Y slot not detected Y Slot flag not properly situated Physical obstructions in path of Plate Y Malfunctioning Y slot sensor 521 X slot not detected X Slot flag not properly situated Physical obstructions in path of Plate X Malfunctioning X slot sensor 522 Lamp X failure Look for all four lights and replace any burned out bulbs Al
128. u do not want to use it sample Database NOTE The Sample ID field and the Keyword field must be used Cancel za za Human Diagnostics Worldwide 53 138 DAL ELISA Strategy Software Settings Continued OPTION DESCRIPTION Set parameters for how to run the tests and how to handle the results TE Ela Strategy in ELISA Mode gaye Reagent oE instrument performance in I EIA Strategy exchange for reagent economy Auto Accept Curve default How to run the tests and how to handle the results The curve generated is automatically accepted Manual Accept Curve When tests are complete they remain in the test list The user can review the step log to see if 4 Save reagent aspirate extra 100ul instead of 200 there are timing errors etc The user should check the curve set and click the accept button Curve records will be written into the database and displayed in the Calibration tab Activate control results after being accepted Auto bi Accept curve and control results Auto 7 Activate curve resulte after being accepted Auto Manual Activate Curve After accepting the curve the curve records go to the Calibration Print sample report after all being accepted Manual k tab They are available for the user to activate After user activates a curve Sample Cancel Results are calculated This setting is helpful when a user chooses Auto Accept Sample and Auto Print Report Accept sa
129. ugged in properly Check the sensor leads for continuity 514 Rinse bottle is empty The instrument detected an empty condition on the wash or rinse bottle If the bottle is full check that the sensor s lead is securely connected to the bottle cap and plugged in properly Wrong cap has been used Make sure the cap with the long wires is inserted into the bottle and closed snug The black plastic separator should be at the bottom of the wires and the wires should not be crossed or touching each other Check that the sensors are submerged in the liquid Pause resume the engine by clicking on kd icon Unscrew and refill the bottle Close the caps tightly and assure that the coloured luer locks and sensors remain plugged in before resuming operation 136 138 Human Elisys Uno User Manual Error Code s Problem 515 Filter Wheel ErrorWheel is not rotating 516 Pressure System Error 517 Vacuum System Error Pressure not building rapidly enough 518 Possible aspiration failure 519 Vacuum over range Solution Check filters wheel pulleys for freedom of movement Select the option Pause Engine from the Management Tab on the menu Select Resume Engine when finished Open and re close each bottle cap to flatten and reset each gasket Check all of the bottle caps and connections for tightness Make sure there are no cracks in the caps tubing or connections Check the operation of the pinch valves If the valve opens but the
130. urve Incomplete z Add calibration test Curve recent white current blue backup gray Control current pink Criteria Show backup Work list Absorbance Concentration Interpretation No items to show Ej Activate Selected Discard Recent Print Preview Print Report Factor o 4 y Remove Save Load Request Figure 4 3 2 1 Calibration Tab 1 Choose Assay Use the drop down menu to choose one of the assays from the list Press the Print Report button to print for the selected assay 2 Add Calibration Test Information Lists the calibrators and controls by name copies required and whether or not they are valid Selections calibrators Select the Curve option to insert a blank and a calibrator for the assay into the work list Select multiple times to add more copies of each This button is not active if the user is running an assay that does not require Select the Control option to add all of the Controls specified in the assay Press the button multiple times to add multiple copies of the controls NOTE The user may also select calibrators controls and blanks individually 3 View Results View the calibration and control results in this area a 32 138 Human Elisys Uno User Manual 4 Work List Buttons Click Save to save the current work list Pressthe Load button to load a previously saved work list Choose any or all of t
131. us The temperatures of the probe coil and reaction plate are 1 Window continually displayed in the ELISYS UNO Status Window The temperature reading of the probe coil and plate are only accurate near 37 C At normal ambient temperatures the reported temperatures are not accurate and often the displayed temperature of the probe coil and plate do not agree and may report higher than the actual temperature When plate heating is turned off so is probe coil heating When running room temperature assays disregard the displayed temperature values 30 138 Human Elisys Uno User Manual Layout Tab Continued Feature Go Home buttons Reset buttons Save Load Edit Verify Description Use these buttons to return to the home positions Press the Reset buttons in Rack 1 and Rack 2 to reset rack as clean Press Reset under Plate to reset wells as clean If using this button make sure that the positions are clean Any tests running that are waiting for clean well positions will continue Press the Save button to save the rack layout Press the Load button to load a previously saved rack layout Press the edit button to edit the well Reads all 96 wells and marks missing or dirty wells found Item No 2 Human gt ae Diagnostics Worldwide 31 138 Calibration Tab Management Routines Lot Registration OC Tracking Sample DB Settings Security Help 2815000500 Example Calcium 42 III No C
132. ways contact your Instrument Service Provider first If all the lamps are lit check for fluid spillage Spillage or an obstructed or damaged optical filter may also cause this message due to decreased detection of light Clean spills immediately and wipe chemical residue away with repeat cleanings using fresh water 523 Channel blanks are not Under Settings select Alignment click on Channel Blanks valid option Run Channel Blanks using the blanking material provided with ELISYS UNO and new clean and clear flat bottom microwells Follow the instructions as prompted 138 138 Human Elisys Uno User Manual HUMAN Gesellschaft fur Biochemica und Diagnostica mbH Max Planck Ring 21 65205 Wiesbaden Germany Tel 49 61 22 99 88 0 Fax 49 61 22 99 88 100 e Mail humanGhuman de www human de
133. xample Glucose Status I Do not automatically show up Figure 5 2 3 7 Calibration Event When selected Calibration Event will display the blank calibrator and controls valid for 7 days After they expire you will have to re run the Calibrators to use that assay You may run more frequent recalibrations and control checks as often as you like To change the time valid you must edit the assay using Assay Editor Human gt Diagnostics Worldwide 69 138 5 3 Running Samples At this point you are ready to begin running samples Click on the Sample tab refer to Section 4 3 3 Sample Tab H Elisys Uno EIA Mode Lot Registration QC Tracking Sample DB Management Routines Settings Security Help Za Ea e253 L Choose tests Enter sample IDs ID Total 1 Test Current Calibration Status Work list rack2 available positions 96 selected samples 0 Test Reps Urgent 122 A 10ulSample A 10ulS ample Read A Absorbance A Anti HAY DiaSorin No Curve A Anti HAY DiaSorin short No Curve A Anti HAY DiaSorin _ No Curve A Anti Hay_ No Curve A Anti HBc DiaSorin No Curve A Ant HBe DiaSorin short No Curve A Anti HBc_ No Curve A Anti HBe DiaSorin No Curve A Anti HBs DiaSorin No Curve A Anti HBs_ No Curve A B 2 Micro MixFix 3wash A B 2 MictoG Washtest No Curve AV B 2 Mictoal MixFix Wa A B 2 Microglobulin AQ B 2 Microgl

Elisys Uno

Contents

Download Pdf Manuals

Related Search

Related Contents