Page 1 English 12-3501-20/12 Phadia ® User Manual...
Page 2 Phadia 100 instrument. The third party software is provided only for use in accordance with these end user license terms.
Page 3: Table Of Contents
Instrument Specification and Installation Routine Assay Run Reagent and Sample Handling Assay Run Editing Functions Assay Run Data Evaluation Assay Run Quality Control Monthly Calibration Quality Assurance Methods, Test Panels, Article Management 10. Printouts 11. Maintenance 12. Error Handling 13. Repacking 14.
Page 4 Phadia 100 - User Manual Instrument Specification and Installation Chapter 1 - Instrument Specification and Installation This chapter describes technical specifications and installation procedure Instrument Intended Use Principal functionality Instrument Guide Sample Carousel Instrument Lifting Points ImmunoCAP/EliA Well Dispenser USB ports/Diskette Drive...
Page 5: Instrument
Principal functionality Phadia 100 is designed to be used together with ImmunoCAP and EliA in vitro diagnostic tests manufactured by Phadia AB. Phadia 100 yields the same analytical results from samples of the same specimen as Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000 within stated tolerance limits.
Page 6: Instrument Guide
Phadia 100 - User Manual Instrument Specification and Installation Instrument Guide Instrument Front Pipette Pipette Arm USB ports/ Washing Solution, Diskette Drive Rinse Solution and Waste Bottles ImmunoCAP/ Sample Carousel EliA Well Dispenser Cover Printer Sample Keyboard Processing Lid/ Carousel...
Page 7 Instrument Specification and Installation Phadia 100 - User Manual Instrument Rear Instrument equipped with USB ports: USB ports Cooling fan COM 2 port TCP/IP connector (COM 1 is used VGA connector internally in (for service only) the instrument) Washing Solution,...
Page 8: Sample Carousel
Phadia 100 - User Manual Instrument Specification and Installation Instrument Lifting Points Lift the instrument by holding under the instrument. Do not lift the instrument by the areas indicated in the picture. Too much weight on these spots might damage the instrument.
Page 9: Immunocap/Elia Well Dispenser
Instrument Specification and Installation Phadia 100 - User Manual ImmunoCAP/EliA Well Dispenser You load ImmunoCAP/EliA Well carriers in the ImmunoCAP/EliA Well Dispenser. The ImmunoCAP/EliA Well Dispenser is placed on top of the processing chamber. Push the cap away and push the carrier downwards until you feel it clicking into place.
Page 10: Washing Solution, Rinse Solution And Waste Bottles
Phadia 100 - User Manual Instrument Specification and Installation Washing Solution, Rinse Solution and Waste Bottles You find the Washing Solution, Rinse Solution and waste bottles to the left of the instrument, behind the Sample Carousel. When you connect these bottles to the instrument, please be sure you connect them in the correct order.
Page 11: Immunocap Waste Container
Instrument Specification and Installation Phadia 100 - User Manual ImmunoCAP Waste Container ImmunoCAP Waste Container is located on the lower left side of ImmunoCAP Carousel in the Processing Chamber. The instru- ment will not indicate when the container is full.
Page 12: Technical Specification
Phadia 100 - User Manual Instrument Specification and Installation Technical Specification Instrument Specification Dimensions Width: 680 mm Depth: 600 mm Height: 440 mm Weight Instrument: 46 kg Total Weight (packaged): 86 kg Mains Power Supply AC 100 V, 50/60 Hz...
Page 13 Instrument Specification and Installation Phadia 100 - User Manual Working Conditions Ambient temperature: 18ºC to 32ºC Ambient air humidity: 10% to 85% RH Ambient air pressure: 860 hPa to 1060 hPa Ambient temperature change: 2ºC/hour (max.) Heat Contribution 310 W (average) 1058 Btu/h Storage Conditions Ambient temperature: -20ºC to +70ºC...
Page 14 Phadia 100 - User Manual Instrument Specification and Installation ImmunoCAP 100 equipped with diskette drive: The serial ports (COM 1, COM 2 and COM 3) are located at the upper part of the rear side of the instrument. These connections will handle serial data communication in accordance with the RS 232 C standard.
Page 15 Processing Errors as well as Assay Result Errors. Problems can occur which have to be solved by an authorized Phadia AB service technician. Before handing over Phadia 100 for service, it must be cleaned with Maintenance Solution kit. Please follow the Directions for Use in Maintenance Solution kit.
Page 16: Solid Phase Specification
Phadia 100 - User Manual Instrument Specification and Installation Training All necessary information about installation and how to operate Phadia 100 safely is included in the shipment. However, if you feel that additional training is required please contact your local Phadia AB representative.
Page 17: Operational Precautions And Limitations
When handling human blood, be aware that there is a biological risk involved. This warning label is to be placed on the waste bottle (see Installation Instructions). Phadia 100 waste bottle collects waste liquids containing human body fluids, which might be infected.
Page 18 EliA methods can not be used together with ImmunoCAP methods. Precaution Phadia 100 is intended for in vitro diagnostic testing, using reagents of Phadia only. When operating Phadia 100, reagents manufactured from human blood components are frequently used.
Page 19: Installation
Instrument Specification and Installation Phadia 100 - User Manual Installation NOTE! Do not unpack until the instrument has reached room temperature. If major temperature differences exist (~10ºC), condensation will occur in the instrument. Accessory box Manual box Remove the metallic clips at the top of the plywood box with a screwdriver.
Page 20: Contents
Phadia 100 - User Manual Instrument Specification and Installation Contents Phadia 100 is delivered in one box containing the instrument and the accessory box. The contents in the accessory box should be according to the following list. Accessory Box The following accessories are included:...
Page 21: Installation Instructions
Instrument Specification and Installation Phadia 100 - User Manual Installation Instructions Remove the accessory and the manual Let the instrument rest bottom plate using the Allen box. on its back on a table with key to unscrew the hexago- the wooden bottom plate nal screws.
Page 22 Phadia 100 - User Manual Instrument Specification and Installation Remove the tape from Remove the tape from the Sample Carousel Cover and the tape the Pipette Arm. Gently lift around the Rinse Solution, Washing Solution and Waste bottles. the arm straight up and move it to the right, away from the Sample Carousel.
Page 23 Instrument Specification and Installation Phadia 100 - User Manual Take out Elution Wells NOTE! The ImmunoCAP Disc and ImmunoCAP Holder ImmunoCAP Holder Disc Elution Wells Disc Holder Disc is fragile and Disc from the accessory box should be handled as glass.
Page 24 The instrument should now be ready to use. WARNING! Do not use radio transmitters or mobile telephones within a radius of 2 metres from Phadia 100. The use of such devices close to the instrument may impair the instrument's performance. 12-3501-20/12...
Page 25: Parameter Set Up
Instrument Specification and Installation Phadia 100 - User Manual Parameter Set Up It is possible to change the default settings for different parameters to adapt Phadia 100 to your needs. Date/Time In Prepare Run mode press Phadia 100 Ver.3.0 14:10:17 1.Prepare Run?
Page 26: Language
For more characters press the shift key and key 0-9 at the same time. Default Method It is possible to choose the method that Phadia 100 displays as a default method in different functions. In Install/Service mode 6.Install/Service press 4.
Page 27: Set Sige Method
Instrument Specification and Installation Phadia 100 - User Manual Press yes. 6.Install/Service 4.System parameters? In System Parameters 6.4.System parameters mode press 2. 1.Language? Press yes. 6.4.System parameters 2.Default Method? Press no until the method 6.4.2.Default Method you want as default appears, Method: ImmunoCAP Specific IgE 0-100? then press yes.
Page 28: Set And Change Passwords
Phadia 100 - User Manual Instrument Specification and Installation Press yes. 6.5.Contrasts 1.Set LCD Contrast? Change the LCD contrast SELECT LCD CONTRAST by pressing the key below BRIGHTER DARKER BRIGHTER or DARKER. Press enter when the contrast is set. Press no.
Page 29: Communication Parameters
Instrument Specification and Installation Phadia 100 - User Manual Type in the new password, 6.1.3.Change Password then press enter. New password:_ Retype the new password, 6.1.3.Change Password then press enter. Confirm password:_ The new password is set. 6.1.3.Change Password NEW PASSWORD SET Communication Parameters To enter this menu you need access to the laboratory password.
Page 30: Configure Phadia 100 For Tcp/Ip
Phadia 100 - User Manual Instrument Specification and Installation Press no until the data bits 6.7.2.Data bits COM2 you want appear, then press Data bits: 8? yes. Press no. 6.7.Communication parameters COM2 2.Data bits? Press yes. 6.7.Communication parameters COM2 3.Stop bits? Press no until the stop bits 6.7.3.Stop bits...
Page 31: Configure Computer Name
Enter. Configure computer name When using more than one Phadia 100 in the same network, the computer name has to be set. To enter this menu you need access to the laboratory password. Follow the steps below when you set the computer name.
Page 32: Routine Assay Run
Phadia 100 - User Manual Routine Assay Run Chapter 2 - Routine Assay Run This chapter describes the set ups and the functions of a routine assay with Phadia 100. Menu Structure Moving in Menus To Enter Data Select Alternatives...
Page 33 Phadia 100 - User Manual Menu Structure When you switch on the instrument normally "Phadia 100" will be displayed for about one minute. For version 2.34 and lower, If the instrument has been in use for a very long time without being switched off, it will take longer time before it is ready for use.
Page 34 Phadia 100 - User Manual Routine Assay Run If you press no you will come to Phadia 100 Ver.3.0 13:48:33 the next menu item (in this case 2.Abort Run? 2.Abort Run). You can also select a key that represents the...
Page 35 Routine Assay Run Phadia 100 - User Manual Select Alternatives In this case you can select an 3.2.2.Specific Run alternative by pressing no and Run: (23) 090522 11:05? then yes on the option you want. You can also enter the sequence number using the number keys.
Page 36 Phadia 100 - User Manual Routine Assay Run Error Messages There are three different types 5.1.Add Method of error messages that can be E103: FILE NOT FOUND! displayed. This is the type that will remain on the display until you press a key (any key).
Page 37 Routine Assay Run Phadia 100 - User Manual The message information may also be displayed automatically when an error occurs. At the message information you can step back in the list of previous errors by pressing message. With no you can step forward again.
Page 38 Phadia 100 - User Manual Routine Assay Run Instrument Panel 12-3501-20/12 Page 2.7...
Page 39 Routine Assay Run Phadia 100 - User Manual Panel The panel consist of the keyboard and the display. The backlit display contains two rows with 40 characters in each row. The keyboard contains 51 keys. The printer is a 40/80 character width printer.
Page 40 Phadia 100 - User Manual Routine Assay Run Menus 1.Prepare Run 1.1.Enter Request 1.2.Print Lists 1.3.Load and Start 1.3.1.Load Samples 1.3.2.Load Reagents 1.3.3.Load ImmunoCAP/Load EliA Well 1.3.4.Start Process 1.4.Edit Request 1.4.1.Edit Sample ID 1.4.1.1.Change Sample ID 1.4.1.2.Change Test 1.4.1.3.Add Test 1.4.1.4.Delete Test...
Page 41 Routine Assay Run Phadia 100 - User Manual 3.Data Evaluation 3.1.Print Patient Report 3.1.1.All Samples in a Run 3.1.2.Specific Sample 3.2.Print Laboratory Report 3.2.1.Summary of Runs 3.2.2.Specific Run 3.2.3.Specific Run, Select Calibrators 3.2.4.Specific Run, switch CC 3.2.5.Specific Run, disable CC 3.2.6.Specific Run, disable blank error...
Page 42 Phadia 100 - User Manual Routine Assay Run 5.Method Setup* 5.1.Add Method 5.2.Edit Method 5.2.1.General parameters 5.2.1.1.Name** 5.2.1.2.Abbreviated name** 5.2.1.3.Allow Monthly calibration** 5.2.1.4.Cal code on ImmunoCAP/EliA Well 5.2.1.5.Sequence number** 5.2.1.6.Method priority** 5.2.1.7.Diluent** 5.2.1.8.Diluent in pos. G 5.2.1.9.Action list number** 5.2.1.10.Reverse Calibrators** 5.2.1.11.Default Cut-off Concentration**...
Page 43 Routine Assay Run Phadia 100 - User Manual 5.2.4.Presentation** 5.2.4.1.X-axis** 5.2.4.1.1.Text** 5.2.4.1.2.Scale** 5.2.4.1.3.Unit** 5.2.4.2.Y-axis** 5.2.4.2.1.Text** 5.2.4.2.2.Scale** 5.2.4.2.3.Unit** 5.2.4.2.4.Fixed scale 5.2.5.Calculation** 5.2.5.1.Calculation type** 5.2.5.2.Normal Weight** 5.2.5.3.Predicted Variance A** 5.2.5.4.Predicted Variance B** 5.2.5.5.Robust Weight** 5.2.5.6.Min. Coeff. of Correlation** 5.2.5.7.Zero-point 5.2.5.8.Lowest concentration 5.2.6.Report Type 5.2.6.1.Cut-off...
Page 44 Phadia 100 - User Manual Routine Assay Run 5.2.7.Tests 5.2.7.1.Add Test 5.2.7.2.Edit Test 5.2.7.2.1.Test name 5.2.7.2.2.Full name 5.2.7.2.3.Replicate 5.2.7.2.4.Report concentration 5.2.7.2.5.Report class 5.2.7.2.6.Report cut-off 5.2.7.2.7.Report cut-off 2/Report ASM class 5.2.7.2.8.Report quotient 5.2.7.2.9.Concentration unit** 5.2.7.2.10.Concentration factor** 5.2.7.2.11.Highest concentration** 5.2.7.2.12.Decimals for conc <10** 5.2.7.2.13.Use Lot Specific Code**...
Page 45 Routine Assay Run Phadia 100 - User Manual 5.3.Delete Method** 5.4.Print Method 5.4.1.Summary of Methods 5.4.2.Specific Method 5.4.3.All Methods 5.5.Export Method 5.5.1.Specific Method 5.5.2.All Methods 5.6.Import Method 6.Install/Service 6.1.Login/Logout 6.1.1.Login 6.1.2.Logout 6.1.3.Change Password 6.2.Test Panels 6.2.1.Add Test Panel 6.2.2.Edit Test Panel 6.2.2.1.Add Test...
Page 46 Phadia 100 - User Manual Routine Assay Run 6.4.8.External Printer Settings 6.4.9.Set sIgE Method 6.5.Contrasts 6.5.1.Set LCD Contrast 6.5.2.Set Printer Contrast 6.6.Article Management* 6.6.1.Add Article 6.6.2.Edit Article 6.6.3.Delete Article 6.7.Communication Parameters* 6.7.1.Baud rate 6.7.2.Data bits 6.7.3.Stop bits 6.7.4.Parity 6.7.5.Port Usage 6.7.6.IDM TCP/IP Address...
Page 47 Routine Assay Run Phadia 100 - User Manual Verification of Instrument Performance To verify the instrument performance before using the instrument in routine runs, please follow the instructions below. A number of laboratories have accreditation for running specified tests. To receive and obtain this accreditation proof regarding the quality of the results is requested.
Page 48 Phadia 100 - User Manual Routine Assay Run • ImmunoCAP Specific IgE Negative Control tested for the same three allergens as above, in duplicate • At least six individual patient samples in duplicate, any allergens Criteria for acceptance of Run 1: •...
Page 49 Routine Assay Run Phadia 100 - User Manual ImmunoCAP Specific IgE Reagents for ImmunoCAP Specific IgE ImmunoCAP Specific IgE ImmunoCAP Specific IgE Calibrators ImmunoCAP Specific IgE Control ImmunoCAP Specific IgE Negative Control Anti-IgE ImmunoCAP ImmunoCAP Allergen d1 ImmunoCAP Allergen e1 ImmunoCAP Allergen t3 or other allergens included in ImmunoCAP Specific IgE Control;...
Page 50 Phadia 100 - User Manual Routine Assay Run Criteria for acceptance of Runs 2 and 3: • Curve controls are within range, the run is accepted by the instrument software • The mean values for ImmunoCAP Specific IgE Control are within given ranges •...
Page 51 Routine Assay Run Phadia 100 - User Manual Criteria for acceptance of Run 1: • The instrument software accepts the curve • The mean values for ImmunoCAP Total IgE Controls are within given ranges Run 2 and 3: • Curve controls 1 and 2 (single replicate, as default) •...
Page 52 Phadia 100 - User Manual Routine Assay Run Protocol for acceptance of ImmunoCAP ECP and ImmunoCAP Tryptase Below you see an example for ImmunoCAP ECP. This is applicable also for ImmunoCAP Tryptase. The reagents differ depending on selected method. Run 1: •...
Page 53 Routine Assay Run Phadia 100 - User Manual ImmunoCAP Specific IgG and ImmunoCAP Specific IgA Reagents for ImmunoCAP Specific IgG ImmunoCAP Specific IgG IgA/IgG Calibrator ImmunoCAP ImmunoCAP Specific IgG Calibrators ImmunoCAP Specific IgG Curve Controls ImmunoCAP Gliadin ImmunoCAP i1 ImmunoCAP Gliadin Control IgA/IgG LMH...
Page 54 Phadia 100 - User Manual Routine Assay Run Criteria for acceptance of Runs 2 and 3: • Curve controls are within range, the run is accepted by the instrument software • The mean values for the controls are within given ranges Criteria for total acceptance of ImmunoCAP Specific IgG: •...
Page 55 Routine Assay Run Phadia 100 - User Manual Protocol for acceptance of ImmunoCAP Specific IgG4 Run 1: • Full calibration curve (0, 3, 15, 35, 120, 300 µg/l, in duplicates - this is set as default in the software when a calibration curve is requested) •...
Page 56 Phadia 100 - User Manual Routine Assay Run EliA IgG, EliA IgA, EliA IgM and EliA Calprotectin Reagents for EliA IgG EliA IgG Conjugate EliA Diluent EliA ANA Control EliA IgG Calibrators EliA dsDNA Wells In addition six individual patient samples per method are required.
Page 57 Tables 3 and 4 are examples of typical results. For your own calculations of CV (%), use the link to the calculation form on the Start Up page on the Phadia 100 cd. P a g e 2 . 2 6...
Page 58 Phadia 100 - User Manual Routine Assay Run Forms for calculation Calculation of CV (%) with two replicates in each of three runs. Table 1 Replicate Run 1 Run 2 Run 3 Mean Within Mean Variance √ V Within Total CV (%) within runs = 100 M Tot √...
Page 59 Routine Assay Run Phadia 100 - User Manual Examples of calculation Calculation of CV (%) with two replicates in each of three runs: Table 3 Replicate Run 1 Run 2 Run 3 Mean Within 2.87 3.43 2.98 3.01 3.27 3.20 Mean 2.94...
Page 60 Mode if you select the menu 6.10.Training-Mode on your display. As long as you are in this mode you can use Phadia 100 without changing anything. This is a copy of the entire software and nothing that you do in this software mode will affect the actual instrument software.
Page 61 Phadia Laboratory Systems consists of the Phadia 100 instrument with software for immunodiagnostic laboratory testing and of ImmunoCAPreagents. Phadia 100 instrument is designed to handle all the steps from request to result. It distributes samples, ImmunoCAP and reagents and processes all the steps from incubation, washing, measuring to calculation and printing of results.
Page 62 Phadia 100 - User Manual Routine Assay Run Monthly Calibration You can choose to run a calibration curve in your run or use a stored calibration curve. The stored calibration curve is valid for the specific calibration code for a maximum time of 28 days as long as the curve controls are within the limits.
Page 63 Routine Assay Run Phadia 100 - User Manual Principles of Operation The instrument is controlled from the panel at the front of the instrument. You load the reagents and samples in the Sample Carousel to the left of the instrument. Positions are marked to simplify the loading of the reagents.
Page 64: Reagent And Sample Handling
Phadia 100 - User Manual Routine Assay Run Load and Start Select 1.3.Load and Start; the software will guide you through loading of reagents and samples. Be sure to load the correct reagent/sample in the correct place in the sample carousel. Inspect the surface of all reagents/samples for air bubbles or film.
Page 65 Routine Assay Run Phadia 100 - User Manual Notes and Warnings When operating Phadia 100 please take the following notes and warnings into consideration: NOTE! Phadia 100 must only be connected to a grounded power outlet (protective ground). NOTE! Before closing the processing lid, check...
Page 66 Wear protective gloves! WARNING! Do not use radio transmitters or mobile telephones within a radius of 2 metres from Phadia 100. The use of such devices close to the instrument may impair the instrument's performance. BIOHAZARD! Two multilingual labels with this message are included in the shipment.
Page 67 Routine Assay Run Phadia 100 - User Manual Calibration Curve Assay A calibration curve must be performed after 28 days or when a new lot number of conjugate or ImmunoCAP (for Total IgE, ECP, Tryptase) is introduced. For more information see chapter 7, Monthly Calibration.
Page 68 Phadia 100 - User Manual Routine Assay Run Messages that can occur CALIBRATION CURVE ALREADY EXISTS. RUN NEW? There are already calibrators for the method you selected. If you press yes you will add new calibrators to the run. If you press no, the existing ones will be used.
Page 69 Routine Assay Run Phadia 100 - User Manual Enter Request You enter a request by starting with the sample identity and then adding the test identities. You can enter the identities from the keyboard or with a barcode reader. If a calibration curve is to be included in the run, you specify the calibration curve as described in the Calibration Curve Assay.
Page 70: Assay Run Editing Functions
Phadia 100 - User Manual Routine Assay Run Type the sample ID (up to 1.1.Enter Request [48] 16 characters) and press enter. Enter Sample ID:_ If you use a barcode reader, the sample ID is entered when you read the barcode.
Page 71 Routine Assay Run Phadia 100 - User Manual Messages that can occur NO ACTIVE CALIBRATORS, ADD TO RUN? There is no stored calibration curve for the method. NO TEST POS LEFT, Skip Sample ID? There is no position left for ImmunoCAP/EliA Well. If you press yes the sample identity will be removed.
Page 72 Phadia 100 - User Manual Routine Assay Run INSTRUMENT DILUTION TOO HIGH Instrument dilution exceeds 100. DILUTION GREATER THAN 100. CONTINUE Instrument dilution and pre.dilution exceeds 100. Press yes if you want to 1235 (sIgE)Test:f3 skip the test. You can enter this NO TEST POS.
Page 73 Routine Assay Run Phadia 100 - User Manual Load and Start These steps will include the loading of system liquids, reagents, samples, ImmunoCAP/EliA Wells and finally starting up the run. There will be an amount and a position given for each component. In some cases you have to enter the calibration code of the conjugate and ImmunoCAP/EliA Wells.
Page 74 Phadia 100 - User Manual Routine Assay Run Warnings that may prevent entering RUN IS NOT PREPARED There is no currently prepared run. PROCESS IS RUNNING There is an assay run being processed. You may prepare a new run, but you cannot load and start.
Page 75 Routine Assay Run Phadia 100 - User Manual Messages that can occur WASH SOLUTION LOT NUMBER REGISTRERED You can use the barcode reader to register the lot number for Washing Solution. Add all the required 1.3.1.Load Samples samples. Press enter until all LOAD 120 ul SOI IN POS 4 solutions are loaded.
Page 76 Phadia 100 - User Manual Routine Assay Run Check the calibration 1.3.2.Load Reagents Cal Code:1A_ code of the conjugate and load LOAD 1800 ul sIgE-CONJ IN POS A the conjugate in the instrument. You find the calibration code on the bottle. Type the calibra-...
Page 77 Routine Assay Run Phadia 100 - User Manual Press yes to start loading 1.3.Load and Start ImmunoCAP/EliA Wells. 3.Load ImmunoCAP/EliA Well? Press enter to start a 1.3.3.Load ImmunoCAP/EliA Well blank check. PRESS ENTER TO START A BLANK CHECK If a blank error occurs, se chapter 12, Error Handling.
Page 78 Phadia 100 - User Manual Routine Assay Run LOT SPECIFIC CODE NOT EQUAL Present Lot Specific Code is not the same as the code used for the calibrators. When all ImmunoCAP/ 1.3.3.Load ImmunoCAP/EliA Well EliA Wells are loaded, remove ALL LOADED. REMOVE CARRIER. PRESS ENTER the carrier.
Page 79 Routine Assay Run Phadia 100 - User Manual EXPIRY DATE PASSED, CONTINUE? This question will appear on the display if bar-code is read on a reagent if the expiry date is passed. Press yes to use anyway or no to use another reagent.
Page 80 Phadia 100 - User Manual Routine Assay Run DAILY MAINTENANCE NOT PERFORMED Perform Daily Maintenance. WEEKLY MAINTENANCE NOT PERFORMED Perform Weekly Maintenance. MONTHLY MAINTENANCE NOT PERFORMED Perform Monthly Maintenance. TEMPERATURE SENSORS DIFFER For corrective actions see Action list. To start the process press 1.3.4.Start Process...
Page 81 Routine Assay Run Phadia 100 - User Manual P a g e 2 . 5 0 12-3501-20/12...
Page 82 Phadia 100 - User Manual Reagent and Sample Handling Chapter 3 - Reagent and Sample Handling This chapter describes reagent and sample handling, the use of different tubes and dilutions Reagent Handling, General Reagent Handling, ImmunoCAP Specific IgA, ImmunoCAP Specific IgG,...
Page 83 Reagent and Sample Handling Phadia 100 - User Manual Reagent Handling, General General and specific Calibrators, Curve Controls, Conjugate, Quality reagents Control, Development Solution, Stop Solution, FluoroC and Diluent are reagents for the Phadia 100 methods. The ones used in the Phadia instrument can be divided into method specific reagents and general reagents.
Page 84 Phadia 100 - User Manual Reagent and Sample Handling Pooling In general it is not recommended to pool reagents. Conjugates can be pooled once, but only with another conjugate having the same lot number and only from a new vial to an old vial.
Page 85 It is also very important that the instrument is well maintained according to the maintenance procedures in Chapter 11 in Phadia 100 User Manual. Things to be aware of before and after an assay •...
Page 86 • Do a thorough cleaning of the instrument by performing Monthly Maintenance, see chapter 11 in Phadia 100 User Manual. When performing Monthly Maintenance, it is very important to clean the Washing- and Rinse Solution bottles and the Elution Wells Disc thoroughly to get rid of all the Maintenance Solution.
Page 87 Reagent and Sample Handling Phadia 100 - User Manual performed as a corrective action according to the action list when having problems with the IgG, IgA and IgM assays. • For the next assay run, use a new bottle of conjugate. In the case when the message: Reagent blank is too high occurs, use a new Development Solution bottle as well.
Page 88 It is very important to know the dead volume of the tubes used. Phadia 100 will prompt you by the software to place a specific volume of the samples into the sample carousel.
Page 89 Reagent and Sample Handling Phadia 100 - User Manual Brand Inner diameter Outer diameter Height Comment Dead volume (mm) (mm) (mm) (µl) Source unknown gl, f Sarstedt pl, f Sarstedt pl, cp Sarstedt pl, c Note! Cap must be cut off...
Page 90 Phadia 100 - User Manual Reagent and Sample Handling Instrument Dilutions and Type of Sample Instrument dilutions with higher dilution factor than 10 are made in Diameter two steps and require an empty tube - dilution tube- to make the first approximately step of the dilution in (dilution 1:10).
Page 91 Reagent and Sample Handling Phadia 100 - User Manual P a g e 3 . 1 0 12-3501-20/12...
Page 92 Phadia 100 - User Manual Assay Run Editing Functions Chapter 4 - Assay Run Editing Functions This chapter describes how to select, add, change and delete a prepared assay run Edit Request Change Dilution for Sample Change Replicate or Dilution for Test...
Page 93: Edit Request
Assay Run Editing Functions Phadia 100 - User Manual Edit Request In Edit Request mode you can change sample identity, delete sample identity, change test name, add test name, delete test name and delete calibrators from a prepared assay run.
Page 94: Change Dilution For Sample
Phadia 100 - User Manual Assay Run Editing Functions Change Dilution for Sample The following steps describes how you change the replicate and dilution for a sample when you are in Enter Request in the Prepare Run mode. You can change the dilu- 1.1.Enter Request...
Page 95: Change Replicate Or Dilution For Test
Assay Run Editing Functions Phadia 100 - User Manual Change Replicate or Dilution for Test When you are entering a request you can change the dilution factor for a sample being run in the Specific IgE, Specific IgA, Specific IgG, EliA IgA, EliA IgG or EliA IgM method by pressing the shift and enter when you have typed the test name.
Page 96: Change Sample Id
Phadia 100 - User Manual Assay Run Editing Functions Change Sample ID The following steps describe how you can change the identity of a specific sample. In Prepare Run mode Phadia 100 Ver.3.0 14:10:17 press yes. 1.Prepare Run? In Enter Request press 4.
Page 97 Assay Run Editing Functions Phadia 100 - User Manual Messages that can occur SAMPLE ID ALREADY ENTERED The entered sample ID has already been used in this run. YOU CANNOT CHANGE TO CALIBRATORS It is not possible to enter "cal" here if you want to add calibrators.
Page 98: Delete Sample Id
Phadia 100 - User Manual Assay Run Editing Functions Delete Sample ID The following steps describes how you can delete a sample and all included tests. In Prepare Run mode Phadia 100 Ver.3.0 14:10:17 press yes. 1.Prepare Run? In Enter Request press 4.
Page 99: Delete Calibrators
Assay Run Editing Functions Phadia 100 - User Manual Delete Calibrators The following steps describes how you can delete calibrators from a run. In Prepare Run mode press Phadia 100 Ver.3.0 14:10:17 yes. 1.Prepare Run? In Enter Request press 4.
Page 100: Select New Method
Phadia 100 - User Manual Assay Run Editing Functions Select New Method The following steps describes how you change the method when you are in Enter Request in the Prepare Run mode. You can enter tests belonging to different methods.
Page 101: Select Quality Control Manually
Assay Run Editing Functions Phadia 100 - User Manual Select Quality Control Manually The following steps describes how you choose quality controls with status Manual when you are in Enter Request in the Prepare Run mode. NOTE! In each method a maximum of 26 quality controls can be defined. In EliA method 13 quality controls are predefined and the operator can define the remaining 13.
Page 102: Change Test
Phadia 100 - User Manual Assay Run Editing Functions Change Test In Change Test you can change test name, replicate and dilution factor for a specific sample. In Prepare Run mode press Phadia 100 Ver.3.0 14:10:17 yes. 1.Prepare Run? In Enter Request press 4.
Page 103 Assay Run Editing Functions Phadia 100 - User Manual Delete the old test name 1.4.1.2.Change Test [1239] and type the new test name (up Enter new Test name: (sIgE) t3_ to five characters) over the old and press enter. If you want to change the method, press alt before you enter the new test.
Page 104 Phadia 100 - User Manual Assay Run Editing Functions Type the desired number 1.4.1.2.Change Test [1239] (between 1 and 5) of replicates Enter Replicate Number:1_ for the selected test and press enter. If you do not want to change the replicate just press enter.
Page 105 Assay Run Editing Functions Phadia 100 - User Manual METHOD NOT COMPATIBLE Adding this method is not possible, there is already a method used that is not compatible with the method you selected. INSTRUMENT DILUTION TOO HIGH The wanted instrument dilution exceeds 100.
Page 106: Add Test
Phadia 100 - User Manual Assay Run Editing Functions Add Test The following steps describes how you can add tests to a specific sample. In Prepare Run mode press Phadia 100 Ver.3.0 14:10:17 yes. 1.Prepare Run? In Enter Request press 4.
Page 107 Assay Run Editing Functions Phadia 100 - User Manual Type the test names and 1239 (sIgE)Test:_ [09] press enter for each test name. t3, f2 You can also use the barcode reader to enter tests. To change the method press alt.
Page 108 Phadia 100 - User Manual Assay Run Editing Functions To save the entered tests 1239 (sIgE)Test:_ [08] press enter again. g2. t3. f2 If you do not want to save the tests press mode. Messages that can occur NO ACTIVE CALIBRATORS, ADD TO RUN? There is no stored calibration curve for the method.
Page 109: Delete Test
Assay Run Editing Functions Phadia 100 - User Manual Delete Test The following steps describes how you can delete tests from a specific sample. In Prepare Run mode Phadia 100 Ver.3.0 14:10:17 press yes. 1.Prepare Run? Press 4. 1.Prepare Run 1.Enter Request?
Page 110 Phadia 100 - User Manual Assay Run Editing Functions To delete the selected test 1.4.1.4.Delete Test [1239] press enter. PRESS ENTER TO DELETE TEST If you do not want to delete the test, press mode. If all tests are deleted the sample ID will be deleted as well.
Page 111: Add Qc
Assay Run Editing Functions Phadia 100 - User Manual Add QC To reach this function, you first have to login with the laboratory password (the password at delivery is “unicap”). It is recommended to use the minimum and maximum range values given in the Directions for Use for the Quality Control, or for EliA on the package certificate.
Page 112 Phadia 100 - User Manual Assay Run Editing Functions Type the Identity of the 5.2.9.1.Add QC [sIgE] Quality Control (up to eight Identity: characters) and press enter to confirm this step. Messages that can occur SAME QUALITY CTRL IDENTITY ALREADY EXISTS The identity is already used by another QC.
Page 113 Assay Run Editing Functions Phadia 100 - User Manual Type the maximum al- 5.2.9.1.Add QC [sIgE] lowed % CV (10.0 is default). %CV limit resp: 10.0 Press enter to confirm this step. NOTE! Make sure not to enter values for ex-...
Page 114 Phadia 100 - User Manual Assay Run Editing Functions If you are using ImmunoCAP Specific IgE Negative control as quotient, type 0 for Range minimum. NOTE! If expected mean value, expected standard deviation and maximal allowed standard deviation have been defined, the Range minimum will be overridden.
Page 115 Assay Run Editing Functions Phadia 100 - User Manual NOTE! Only use this function if you want to change the default order of the Quality Controls. The instrument displays a 5.2.9.1.Add QC [sIgE] message that the quality con- QUALITY CONTROL ADDED trol is added.
Page 116: Edit Qc
Phadia 100 - User Manual Assay Run Editing Functions Edit QC In the Edit QC mode it is possible to change status, identity, test name, replicate, response, expected concetration, standard deviation, limit standard deviation, range minimum and maximum, log start date and lot number.
Page 117: Set Status
Assay Run Editing Functions Phadia 100 - User Manual Warnings that may prevent entering NO QUALITY CONTROLS EXIST There is no QC defined for the method. Select the Quality Control 5.2.9.2.Edit QC [sIgE] you want to edit by pressing no...
Page 118: Test Name
Phadia 100 - User Manual Assay Run Editing Functions Messages that can occur SAME QUALITY CTRL IDENTITY ALREADY EXISTS The identity is already used by another QC. Test name The following step describes how you can change the test name for the Quality Control.
Page 119: Coefficient Of Variance Limit Response
Assay Run Editing Functions Phadia 100 - User Manual Delete or type over the 5.2.9.2.Edit QC [sIgE/sIgE Pos] old number of replicates. Press Replicate: 1 1, 2, 3, 4 or 5 depending on how many replicates you want to run. Press enter to confirm this step.
Page 120: Expected Standard Deviation
Phadia 100 - User Manual Assay Run Editing Functions LOG DATA RUN DATE, TIME---LOT NO---CAL CODE--CONCENTRATION 090512 11:14 AVMAB 0.72 0.65 090513 11:18 AVMAB 0.66 0.68 090514 12:58 AVMAB 0.61 0.69 090515 13:02 AVMAB 0.70 0.69 090516 11:05 AVMAB 0.73 0.69...
Page 121: Limit S
Assay Run Editing Functions Phadia 100 - User Manual LOG DATA RUN DATE, TIME---LOT NO---CAL CODE--CONCENTRATION 090512 11:14 AVMAB 0.72 0.65 090513 11:18 AVMAB 0.66 0.68 090514 12:58 AVMAB 0.61 0.69 090515 13:02 AVMAB 0.70 0.69 090516 11:05 AVMAB 0.73 0.69...
Page 122: Range Minimum
Phadia 100 - User Manual Assay Run Editing Functions Press yes. 5.2.9.2.Edit QC [sIgE/sIgE Pos] 8.Limit s? Delete or type over the 5.2.9.2.Edit QC [sIgE/sIgE Pos] old maximum allowed stan- Limit s: 3 dard deviation. Type the new maximum allowed standard de-...
Page 123: Log Start Date
Assay Run Editing Functions Phadia 100 - User Manual Press yes. 5.2.9.2.Edit QC [sIgE/sIgE Pos] 10.Range maximum? Delete or type over the 5.2.9.2.Edit QC [sIgE/sIgE Pos] old highest allowed concentra- Range maximum: 4.2 tion. Type the new highest al- lowed concentration or type 0 (zero) to deactivate the func- tion.
Page 124: Predilution Factor
Phadia 100 - User Manual Assay Run Editing Functions Predilution factor The following step describes how you can change the predilution factor. In Edit QC mode press 13. 5.2.9.2.Edit QC [sIgE/sIgE Pos] 1.Status? Press yes. 5.2.9.2.Edit QC [sIgE/sIgE Pos] 13.Predilution factor? Delete or type over the 5.2.9.2.Edit QC...
Page 125: Order
Assay Run Editing Functions Phadia 100 - User Manual Choose the type of QC 5.2.9.2.Edit QC [sIgE/sIgE Pos] you want, CONCENTRA- Type of QC: CONCENTRATION? TION, QUOTIENT QUALITATIVE, by pressing no until the desired type is dis- played. Then press yes.
Page 126: Change Qc With New Lot
Phadia 100 - User Manual Assay Run Editing Functions Change QC with new Lot When changing to a new lot number, it is necessary to change the expected concentration, the expected s and the limit s, or the range minimum and maximum, besides the lot number.
Page 127: Skip Immunocap/Elia Well Loading
Assay Run Editing Functions Phadia 100 - User Manual Skip ImmunoCAP/EliA Well Loading The following steps describes how to skip loading a specific ImmunoCAP/EliA Well when you are in Load and Start mode. This can be done if for example you find that you do not have the required ImmunoCAP in stock.
Page 128: Load Old Run
Phadia 100 - User Manual Assay Run Editing Functions Load Old Run In some cases you may want to load a stored run. This function will make a copy of requests for one already assayed and stored run, for example if you want to rerun a whole assay run.
Page 129 Assay Run Editing Functions Phadia 100 - User Manual Messages that can occur METHOD NOT COMPATIBLE Currently defined methods does not match the methods in the selected run. P a g e 4 . 3 8 12-3501-20/12...
Page 130: Abort Prepared Run
Phadia 100 - User Manual Assay Run Editing Functions Abort Prepared Run If you want to abort a prepared run or a run that is being processed select the Abort Run mode. When you aborted the process you have to remove the reagents, samples and ImmunoCAP/EliA Well from the instrument.
Page 131: Delete All Request Data
Assay Run Editing Functions Phadia 100 - User Manual Delete All Request Data In Abort Prepared Run 2.1.Abort Prepared Run mode press yes to delete all the 1.Delete all Request Data? request data for the prepared run. Warnings that may prevent entering RUN IS NOT PREPARED There is no run currently prepared.
Page 132: Remove Single Immunocap/Elia Well
Phadia 100 - User Manual Assay Run Editing Functions Remove Single ImmunoCAP/EliA Well This is used in case the wrong ImmunoCAP/EliA Well was loaded, and this was noticed before starting the process. In the Abort Prepared Run 2.1.Abort Prepared Run mode press no.
Page 133 Assay Run Editing Functions Phadia 100 - User Manual NOTE! ImmunoCAP and EliA Wells are not la- belled. Due to this fact you have to discard them. P a g e 4 . 4 2 12-3501-20/12...
Page 134: Remove All Immunocap/Elia Well
Phadia 100 - User Manual Assay Run Editing Functions Remove All ImmunoCAP/EliA Well In the Abort Prepared Run 2.1.Abort Prepared Run mode press 3. 1.Delete all Request Data? Press yes. 2.1.Abort Prepared Run 3.Remove all ImmunoCAP/EliA Well? Warnings that may prevent entering...
Page 135: Abort Process
Assay Run Editing Functions Phadia 100 - User Manual Abort Process If you want to abort a run that is being processed, you can select the Abort Run mode. When you have aborted the process, you have to remove the reagents and ImmunoCAP/EliA Well from the instrument.
Page 136 Phadia 100 - User Manual Assay Run Data Evaluation Chapter 5 - Assay Run Data Evaluation This chapter describes the data evaluation with Phadia 100 Data Evaluation Print Patient Report Print All Samples in a Run Print Specific Sample Print Laboratory Report...
Page 137: Data Evaluation
Assay Run Data Evaluation Phadia 100 - User Manual Data Evaluation In the Data Evaluation mode you can print patient reports, laboratory reports and export/import data for storage or evaluation. The last 20 assay runs are automatically stored. The laboratory report and patient reports for these runs can be printed at any time.
Page 138: Print Patient Report
Phadia 100 - User Manual Assay Run Data Evaluation Print Patient Report Patient reports can be printed for a whole assay run or a specific sample in a run. In Prepare Run mode Phadia 100 Ver.3.0 14:10:17 press 3. 1.Prepare Run? Press yes.
Page 139: Print Specific Sample
Assay Run Data Evaluation Phadia 100 - User Manual Print Specific Sample In Print Patient Report 3.Data Evaluation press yes. 1.Print Patient Report? Press no. 3.1.Print Patient Report 1.All Samples in a Run? Press yes. 3.1.Print Patient Report 2.Specific Sample?
Page 140: Print Laboratory Report
Phadia 100 - User Manual Assay Run Data Evaluation Print Laboratory Report In this module you can print a summary of processed runs stored in the instrument, laboratory reports for processed runs and a laboratory report for processed runs with selected calibrators.
Page 141: Re-Evaluate And Print Specific Run With Selected Calibrators
Assay Run Data Evaluation Phadia 100 - User Manual Warnings that may prevent entering NO RUNS EXIST There is no processed run to print laboratory reports for. Select the assay run you 3.2.2.Specific Run want to print by pressing no...
Page 142: Switch Curve Controls
Phadia 100 - User Manual Assay Run Data Evaluation Press yes. 3.2.Print Laboratory Report 3.Specific Run, select Calibrators? Select the assay run you 3.2.3.Specific Run, select Calibrators want to print by pressing no Run: (34) 090503 08:57? until the run appears, then press yes.
Page 143: Disable Curve Control
Assay Run Data Evaluation Phadia 100 - User Manual Press yes. 3.2.Print Laboratory Report 4.Specific Run, switch CC? Press yes. 3.2.4.Specific Run,switch CC Run: (34) 090503 08:57? Press yes for each method 3.2.4.Specific Run, switch CC you want to switch.
Page 144: Disable Blank Error
Phadia 100 - User Manual Assay Run Data Evaluation Disable Blank Error There is a possibility to print results when the Blank Check has detected a Blank Error. This function should only be used under certain circumstances and only for the following two Blank Errors:...
Page 145 Assay Run Data Evaluation Phadia 100 - User Manual To disable fatal error han- 3.2.Print Laboratory Report dling, press 7 in Print Labora- 1.Summary of Runs? tory Report mode. Press yes. 3.2.Print Laboratory Report 7.Specific Run, disable fatal error? Select the assay run in 3.2.7.Specific Run, disable fatal error...
Page 146: Print Lists
Phadia 100 - User Manual Assay Run Data Evaluation Print Lists In Prepare Run mode Phadia 100 Ver.3.0 14:10:17 press yes. 1.Prepare Run? Press 2. 1.Prepare Run 1.Enter Request? Press yes. 1.Prepare Run 2.Print Lists? To select the list to be...
Page 147 Assay Run Data Evaluation Phadia 100 - User Manual Run Summary This printout lists processed runs stored in the instrument, with date and time for run, methods, calibration code and mode. To print the summary of runs select the option 3.2.1.Summary of Runs on the instrument.
Page 148: Export Data
Phadia 100 - User Manual Assay Run Data Evaluation Export Data Data can be exported to a USB memory, an external USB hard drive or a diskette and then be evaluated. In Prepare Run mode press Phadia 100 Ver.3.0 14:10:17 1.Prepare Run?
Page 149 Assay Run Data Evaluation Phadia 100 - User Manual Messages that can occur MEDIA IS FOR OTHER INSTRUMENT The USB memory, external USB hard drive or diskette is labeled with another instrument Id. Data can only be exported to media labeled with the same instrument Id.
Page 150: Import Data
Phadia 100 - User Manual Assay Run Data Evaluation Import Data Data can be imported from a USB memory, an external USB hard drive or a diskette and then be evaluated. In Prepare Run mode press Phadia 100 Ver.3.0 14:10:17 1.Prepare Run?
Page 151 Assay Run Data Evaluation Phadia 100 - User Manual Messages that can occur NO DATA ON MEDIA There is no data stored on the USB memory, external USB hard drive or diskette. MEDIA IS FOR OTHER INSTRUMENT The USB memory, external USB hard drive or diskette is labeled with another instrument Id.
Page 152: Assay Run Quality Control
Phadia 100 - User Manual Assay Run Quality Control Chapter 6 - Assay Run Quality Control This chapter describes the actions in the Quality Control mode Quality Control Print Log Print Quality Control Log Print Curve Control-Log Edit Log Edit Quality Control-Log...
Page 153: Quality Control
Assay Run Quality Control Phadia 100 - User Manual Quality Control From this mode you can print, edit and export quality control-logs. You can also deactivate and activate control points from this mode. Deactivated control points will not be included in the calculation when the average and CV (coefficient of variation) is calculated for the log.
Page 154: Print Log
Phadia 100 - User Manual Assay Run Quality Control Print Log In this mode you can print quality control-logs and curve control-logs. In Prepare Run mode Phadia 100 Ver.3.0 14:10:17 press 4. 1.Prepare Run? In Quality Control mode Phadia 100 Ver.3.0 14:10:17 press yes.
Page 155: Print Curve Control-Log
Assay Run Quality Control Phadia 100 - User Manual Warnings that may prevent entering NO QUALITY CONTROL-LOGS EXIST There are no quality controls defined in the selected method. Press no until the quality 4.1.1.Quality control-log [sIgE] control-log you want appears, Quality ctrl-log: QC-1 t1? then press yes.
Page 156: Edit Log
Phadia 100 - User Manual Assay Run Quality Control Edit Log You can inactivate and activate points in the quality control and curve control logs. In Prepare Run mode Phadia 100 Ver.3.0 14:10:17 press 4. 1.Prepare Run? Press yes. Phadia 100 Ver.3.0 14:10:17 4.Quality Control?
Page 157: Edit Curve Control-Log
Assay Run Quality Control Phadia 100 - User Manual Warnings that may prevent entering NO QUALITY CONTROL-LOGS EXIST There are no quality controls defined in the selected method. Press no until the quality 4.2.1.Quality control-log [sIgE] control-log you want appears, Quality ctrl-log: QC-1 t1? then press yes.
Page 158 Phadia 100 - User Manual Assay Run Quality Control Press no until the curve 4.2.2.Curve Control Log [sIgE] control-log you want appears, Curve ctrl-log: CC-1? then press yes. Press no until the curve 4.2.2.Curve Control Log [sIgE] control you want appears, then CC-1: 090405 14:29 0.71?
Page 159: Print Calibrators
Assay Run Quality Control Phadia 100 - User Manual Print Calibrators You can print calibration curve and data for selected calibrators. In Prepare Run mode Phadia 100 Ver.3.0 14:10:17 press 4. 1.Prepare Run? Press yes. Phadia 100 Ver.3.0 14:10:17 4.Quality Control? In Print Log press 3.
Page 160: Edit Calibrators
Phadia 100 - User Manual Assay Run Quality Control Edit Calibrators You can press and set calibrators to be the active calibrators for a method. You can also set the acceptance for calibrators to OK, FLAGGED and NOT OK. There is also a password protected function where you can change the response of calibrators.
Page 161: Accept Calibrators
Assay Run Quality Control Phadia 100 - User Manual Warnings that may prevent entering NO CALIBRATORS EXIST There are no stored calibrators for the selected method. Select the calibrators you 4.4.1.Set Active Calibrators [sIgE] want by pressing no until the...
Page 162: Edit Calibrator Point
Phadia 100 - User Manual Assay Run Quality Control Warnings that may prevent entering NO CALIBRATORS EXIST There are no stored calibrators for the selected method. Select the calibrators you 4.4.2.Accept Calibrators [sIgE] want by pressing no (or no and...
Page 163: Export Quality Control-Logs
Assay Run Quality Control Phadia 100 - User Manual Press no until the calibra- 4.4.3.Edit Calibrator Point [sIgE] tor point you want appears and Point: CAL-0.35? then press yes. Type the new response of 4.4.3.Edit Calibrator Point [sIgE] the calibrator point and press Response: (2) 58.3_...
Page 164: Export Curve Control Logs
Phadia 100 - User Manual Assay Run Quality Control Messages that can occur MEDIA IS FOR OTHER INSTRUMENT The USB memory, external USB hard drive or diskette is labeled with another instrument Id. Data can only be exported to media labeled with the same instrument Id.
Page 165 Assay Run Quality Control Phadia 100 - User Manual Warnings that may prevent entering NO CURVE CONTROL-LOGS EXIST There are no Curve Controls for the selected method. CANNOT SELECT THIS METHOD The selected method cannot be used for this operation.
Page 166: Export Calibrators
Phadia 100 - User Manual Assay Run Quality Control Export Calibrators In the Export Quality con- 4.5.ImmunoCAP<->PC trol-log press 3. 1.Export Quality control-logs? Press yes. 4.5.ImmunoCAP<->PC 3.Export Calibrators? Press no until the method 4.5.3.Export Calibrators you want appears, then press Method: ImmunoCAP Specific IgE 0-100? yes.
Page 167 Assay Run Quality Control Phadia 100 - User Manual Messages that can occur MEDIA IS FOR OTHER INSTRUMENT The USB memory, external USB hard drive or diskette is labeled with another instrument Id. Data can only be exported to media labeled with the same instrument Id.
Page 168: Monthly Calibration
Phadia 100 - User Manual Monthly Calibration Chapter 7 - Monthly Calibration This chapter describes the run and acceptance of the monthly calibration Concept General Flow in Phadia 100 Acceptance of Calibration Curve Assay Runs Acceptance of Assay Runs 12-3501-20/12...
Page 169 Monthly Calibration Phadia 100 - User Manual Concept Traditionally a complete set of calibrators has been run in each assay run. The introduction of this integrated immunoassay instrument, comprising sample and reagent pipetting, temperature control, washing and fluorometric measure- ments, has enabled the use of stored calibration curves. The high reproducibility of the reagents and the automated instrument allow established calibration curves to be stored and used in following assay runs.
Page 170 Monthly Calibration Acceptance of Calibration Curve Assay Runs In Phadia 100 numerous functions are checked before the assay is judged by the software as accepted or not. The instrument will automatically after each assay self-check important functions; the assay blank and signal of calibration controls, and the curve fitting.
Page 171 Monthly Calibration Phadia 100 - User Manual Acceptance of Assay Runs There might be occasions when, for example, the curve controls are outside the expected concentration limits. Improper handling and storage of reagents, for instance, will affect the performance negatively. There are two levels of limits for acceptance of curve controls, inner and outer limits.
Page 172 Phadia 100 - User Manual Monthly Calibration Methods using two curve controls The following results are possible in the first run for methods using two curve controls: Results/Curve status Results calculated 1. Both curve Run accepted (OK) controls are OK.
Page 173 Monthly Calibration Phadia 100 - User Manual If the calibration curve was flagged in the first run, the following results are possible in the second run: Results/Curve status Results calculated 1. Both curve Curve flag removed (OK) controls are OK.
Page 174 Phadia 100 - User Manual Monthly Calibration Methods using one curve control in duplicate The following results are possible in the first run for methods using one curve control in duplicate: Results/Curve status 1. Both replicates Results calculated are OK.
Page 175 Monthly Calibration Phadia 100 - User Manual If the calibration curve was flagged in the first run, the following results are possible in the second run: Results/Curve status 1. Both replicates Results calculated Curve flag removed (OK) are OK. 2. One replicate is...
Page 176 Phadia 100 - User Manual Quality Assurance Chapter 8 - Quality Assurance This chapter describes the quality assurance of Phadia 100 in vitro allergy, asthma and autoimmunity testing Introduction Quality Assurance Internal (day-to-day) Quality Control Criteria for Control Samples Quality Control of Specific IgE Assays...
Page 177: Introduction
This chapter gives the basis for how to introduce and use such programs in laboratories using Phadia 100 for in vitro allergy, asthma and auto-immunity testing. P a g e 8 .
Page 178: Quality Assurance
Phadia 100 - User Manual Quality Assurance Quality Assurance The American Society for Quality Control defines quality assurance as “all those planned or systematic actions necessary to provide adequate confidence that a product or service will satisfy given needs”. See Glossary and tables for statistical quality control.
Page 179: Internal (Day-To-Day) Quality Control
Quality Assurance Phadia 100 - User Manual Internal (day-to-day) Quality Control Criteria for Control Samples An ideal control sample should simulate the human serum matrix as closely as possible with respect to biological proteins, lipids, pH, ionic strength and other components.
Page 180 Phadia 100 - User Manual Quality Assurance ImmunoCAP Gliadin IgA Control H are human serum pools at a high concentration level. Ready to use. ImmunoCAP Gliadin IgA/IgG Control L are human serum pools at a low concentration level. Ready to use.
Page 181: Quality Control Of Specific Ige Assays
The mean and SD should be recalculated at regular intervals when more data are collected. For Phadia 100 this is done using the inbuilt software. In this way the laboratory range for each allergen will be more precise, thus avoiding false alarms due to erroneous target value and limits.
Page 182: Quality Control Of Other Allergy, Autoimmunity And Asthma Methods
Phadia 100 - User Manual Quality Assurance Quality control of other allergy, autoimmunity and asthma methods Controls of preferably different concentration levels are used. Sets of control samples are included in each run. Minimum 20 results per control sample are collected from different runs and the mean values ±2 SD and ±...
Page 183: Inspection Of Control Charts
Quality Assurance Phadia 100 - User Manual Example of Control Chart + 3 S D + 2 S D -2 S D -3 S D A control chart is constructed by plotting observed values of control samples from each test occasion in a diagram. After collecting sufficient observa- tions, a statistical calculation is made and control limits of usually mean ±2...
Page 184: Interpretation Of Control Charts
Phadia 100 - User Manual Quality Assurance Example of systematic shift + 3 S D + 2 S D - 2 S D - 3 S D A systematic drift is observed when control results from consecutive assay runs gradually move away from the established mean value.
Page 185 Quality Assurance Phadia 100 - User Manual Rule 1: 1 means one observation exceeding x ± 2 SD. This provides a “warning” and need for further inspection of control data in the assay run. Rule 2: 1 means a run is not accepted if one result is outside x ± 3 SD. This rule is mainly sensitive to random errors but can also detect large systematic errors.
Page 186: External Quality Assessment
Quality Club is an international quality assessment program for laboratories using Phadia 100, Phadia 250 or Phadia 1000 for in vitro allergy, asthma and autoimmunity testing. Today, more than 800 testing laboratories are active club members.
Page 187: Monthly Report
Quality Assurance Phadia 100 - User Manual Participation in the external quality assessment programs of Quality Club gives the laboratory management and staff a possibility to compare their in vitro test results with results obtained in other laboratories worldwide. As there are no established true values for in vitro allergy, asthma and autoimmunity testing, the common mean values obtained in Quality Club programs are considered to be the best estimates of true values.
Page 188: Summary Reports
Phadia 100 - User Manual Quality Assurance Results from all labs Cat dander (e1) N (except outliers) No of participating labs: 530 Median 28,9 kU Mean 28,8 kU 2,52 kU 8,74 % Mean - 2 SD 23,8 kU Mean + 2 SD...
Page 189: Quality Control With Phadia 100
Quality Assurance Phadia 100 - User Manual Quality Control with Phadia 100 Control Charts The instrument software program uses control charts to monitor internal quality control. There are two ways to define the limit lines. When a new quality control sample is used, no expected values obtained in the laboratory are available.
Page 190: Expected Results
Quality Club program than for other immunodiagnostic procedures. External quality assessment programs involving different specific IgE methods show Phadia 100 to be the most robust user-independent and reproducible specific IgE test on the market. 12-3501-20/12...
Page 191: Quality Costs
Quality Assurance Phadia 100 - User Manual Quality Costs It is important to understand that the concept of quality costs is broader than the cost of quality control. Without this basic understanding, the only costs considered will be the costs associated with day-to-day quality control and external quality assessment.
Page 192: Methods, Test Panels, Article Management
Phadia 100 - User Manual Methods, Test Panels, Article Management Chapter 9 - Methods, Test Panels, Article Management This chapter describes how to add, edit and delete methods, test panels and article management 5.Method Setup* 5.1.Add Method 5.2.Edit Method 5.2.1.General Parameters 5.2.2.Reagents**...
Page 193: Method Setup
Methods, Test Panels, Article Management Phadia 100 - User Manual 5.Method Setup* The Phadia 100 instrument offers several methods to use: • ImmunoCAP Specific IgE • ImmunoCAP Specific IgE 0-100 • ImmunoCAP Total IgE • ImmunoCAP ECP • ImmunoCAP Tryptase •...
Page 194 Phadia 100 - User Manual Methods, Test Panels, Article Management Press yes. 5.Method Setup 1.Add Method? In Method Setup you can: 5.1.Add Method 5.2.Edit Method 5.3.Delete Method 5.4.Print Method 5.5.Export Method 5.6.Import Method You can find the whole Method Setup structure in chapter 2.
Page 195: Add Method
Methods, Test Panels, Article Management Phadia 100 - User Manual 5.1.Add Method Here you can add new methods USE EXISTING METHOD AS TEMPLATE The easiest way to create a new method is to select one of the existing. Confirm with yes.
Page 196: Edit Method
Phadia 100 - User Manual Methods, Test Panels, Article Management 5.2.Edit Method You can select to edit presentations, calculation, report types, tests, unknowns and Quality Control. These functions are described in the following sections. NOTE! It is not possible to edit general para-...
Page 197 Methods, Test Panels, Article Management Phadia 100 - User Manual 5.2.1.3.Allow Monthly calibration** Select monthly calibration or not with the yes or no keys. Confirm with yes. 5.2.1.4.Cal code on ImmunoCAP/EliA Well Select yes if batches of ImmunoCAP and conjugate has to be connected, for example Total IgE, ECP och Tryptase.
Page 198: Reagents
Phadia 100 - User Manual Methods, Test Panels, Article Management 5.2.2.Reagents** You can set parameters about the volumes, incubation times and the identity of the reagents. First step is to select type of reagent; Sample, Conjugate, Development Solution, or Stop Solution. Confirm with yes.
Page 199 Methods, Test Panels, Article Management Phadia 100 - User Manual 5.2.3.1.2.2.Identity** Type the identity of the curve control. Confirm with enter. 5.2.3.1.2.3.Test name** Type the Test name of the ImmunoCAP, maximum 5 characters, that will be used together with the curve control, confirm with enter.
Page 200 Phadia 100 - User Manual Methods, Test Panels, Article Management 5.2.3.1.3.Delete Curve ctrl** Select the Curve Control you want to delete by pressing no until it appears, then press yes. You will be prompted to PRESS ENTER TO DELETE CURVE CTRL.
Page 201 Methods, Test Panels, Article Management Phadia 100 - User Manual 5.2.3.2.6.Low RU on zero-point** You can enable or disable this function. Disable for example when you run EliA methods in order to avoid Low RU error. 5.2.3.2.7.Quotient Point Define the default calibrator point to be used for calculating the quotient when reporting results.
Page 202: Presentation
Phadia 100 - User Manual Methods, Test Panels, Article Management 5.2.4.Presentation** In this function you can change the presentation of results on the X and/or the Y-axis. 5.2.4.1.X-axis** Press the yes key to be able to change parameters of the X-axis of the calibration curve graph.
Page 203: Calculation
Methods, Test Panels, Article Management Phadia 100 - User Manual 5.2.4.2.3.Unit** Type the unit you want and press enter. 5.2.4.2.4.Fixed scale** Select yes or no. If yes enter min. and max. limits. 5.2.5.Calculation** In this function you can change calculation-parameters.
Page 204: Report Type
Phadia 100 - User Manual Methods, Test Panels, Article Management 5.2.5.7.Zero-point Here you define a curve with the lower part linear and the upper part curved. Zero-point switch: >0 index for the calibrator where the curve switch from linear regression to a logistic function.
Page 205 Methods, Test Panels, Article Management Phadia 100 - User Manual 5.2.6.2.1.Concentration unit** Type the unit you want, confirm with enter. 5.2.6.2.2.Text below lowest Type the text you want, confirm with enter. 5.2.6.2.3.Add Class border** Define concentration and class text. 5.2.6.2.4.Edit Class border Select class border, type the text for samples with results above.
Page 206 Phadia 100 - User Manual Methods, Test Panels, Article Management 5.2.6.3.Cut-off 2 (for ASM class) 5.2.6.3.1.Text below lowest Type text for below lowest cut-off 2/ASM class. 5.2.6.3.2.Add Class border** Define limit and text for a new Class border. 5.2.6.3.3.Edit Class border Select Class border, type new text for values above.
Page 207: Tests
Methods, Test Panels, Article Management Phadia 100 - User Manual 5.2.6.5.3.Edit Class border 5.2.6.5.4.Delete Class border** 5.2.7.Tests In this function it is possible to add, edit, and delete tests, and to change report. 5.2.7.1.Add Test Type a new test name, confirm with enter.
Page 208 Phadia 100 - User Manual Methods, Test Panels, Article Management 5.2.7.2.Edit Test Type the test name of the test you want to edit, confirm with enter. Messages that can occur ENTERED TEST DOES NOT EXISTS The entered test does not exist. Please, check the spelling.
Page 209 Methods, Test Panels, Article Management Phadia 100 - User Manual 5.2.7.2.8.Report quotient Select report quotient, YES, YES PERCENT, or NO. Confirm with yes. Quotient is the ratio between a sample value and the class border. 5.2.7.2.9.Concentration unit** 5.2.7.2.10.Concentration factor** 5.2.7.2.11.Highest concentration** 5.2.7.2.12.Decimals for conc <10**...
Page 210 Phadia 100 - User Manual Methods, Test Panels, Article Management 5.2.7.2.18.Emphasize on reports** Select how the test shall be reported with the yes or no keys. Confirm with yes. 5.2.7.2.19.Quant Below undiluted Type in text to be written on lab report. For undiluted tests below the curve.
Page 211: Unknowns
Methods, Test Panels, Article Management Phadia 100 - User Manual 5.2.7.4.Change Report for All In this function you can change report parameters for all tests within a method, that have the same parameters. To make the selection step through and define the parameters from Report concentration to Report quotient.
Page 212: Quality Control
Phadia 100 - User Manual Methods, Test Panels, Article Management 5.2.8.3.%CV limit** Type the largest allowed %CV. This function will be disabled if you type 0. 5.2.9.Quality control Here you define how you want controls to be handled in an assay. Once a control is defined as Status ACTIVE in the method, the result will automatically be logged.
Page 213 Methods, Test Panels, Article Management Phadia 100 - User Manual 5.2.9.2.Edit QC In the Edit mode it is possible to change status, identity, test name, replicate, response, expected conc. and s, limit s, range minimum and maximum as well as log start date and number.
Page 214 Phadia 100 - User Manual Methods, Test Panels, Article Management Messages that can occur ENTERED TEST DOES NOT EXIST The test name does not exist for the method. Please, check the spelling. SAME QC IDENTITY ALREADY EXISTS The identity is already used by another QC.
Page 215 Methods, Test Panels, Article Management Phadia 100 - User Manual 5.2.9.2.11.Log start date Type the the first date you want the QC to be included in the print-out. QC before that date will not be printed. Use the format year-month-day.
Page 216: Delete Method
Phadia 100 - User Manual Methods, Test Panels, Article Management 5.3.Delete Method Select Method, confirm with yes. The display will prompt you to PRESS ENTER TO DELETE METHOD Press enter, and you will get the message METHOD DELETED If you try to delete a default method the display shows...
Page 217: Print Method
Methods, Test Panels, Article Management Phadia 100 - User Manual 5.4.Print Method In the Print Method mode it is possible to print summary, specific method or all method. See chapter 10, Printout, for examples of the printing lists. 5.4.1.Summary of Methods Selecting Summary of methods will give you a list of all methods that are defined in the actual Phadia 100.
Page 218: Export Method
Phadia 100 - User Manual Methods, Test Panels, Article Management 5.5.Export Method In the Export Method mode it is possible to export methods to a USB memory, an external USB hard drive or a diskette to store the data or distribute to another instrument.
Page 219: All Methods
Methods, Test Panels, Article Management Phadia 100 - User Manual MEDIA WRITE-PROTECTED, ABORT? Remove the write protection or change the USB memory, external USB hard drive or diskette. Press no to continue or press yes to abort. 5.5.2.All Methods After selecting All methods you will be prompted to...
Page 220: Import Method
Phadia 100 - User Manual Methods, Test Panels, Article Management 5.6.Import Method In this mode it is possible to import methods from a USB memory, an external USB hard drive or a diskette. After selecting Import Method the display will prompt you to...
Page 221: Test Panels
Methods, Test Panels, Article Management Phadia 100 - User Manual 6.2.Test Panels If you want to create an assay run set up for repeated use, you can create test panels. You can add a maximum of 50 test panels with 46 tests each. A panel can consist of up to 4 methods.
Page 222: Edit Test Panel
Phadia 100 - User Manual Methods, Test Panels, Article Management Type another test name SELECT METHOD (up to five characters) you want sIgE tIgE ECP sIgG sIgA Tryp to add to the test panel. Con- firm this step with enter.
Page 223 Methods, Test Panels, Article Management Phadia 100 - User Manual If you press alt, choose a SELECT METHOD method by pressing the key sIgE tIgE Phad ECP below the name. Type the number of repli- 6.2.2.1.Add Test ["test panel"] cates you want and press en- Enter Replicate number: 1 ter.
Page 224: Delete Test Panel
Phadia 100 - User Manual Methods, Test Panels, Article Management 6.2.3.Delete Test Panel Go to 6.2.Test Panel (as described in the section Add Test Panel) and follow the instructions below. In the Test Panels mode 6.2.Test Panels press 3. 1.Add Test Panel? Press yes.
Page 225: Article Management
Methods, Test Panels, Article Management Phadia 100 - User Manual 6.6.Article Management 6.6.1.Add Article If you are working with a bar code reader and you receive a new article, for example a new allergen you need to add the article package code to the instrument.
Page 226: Edit Article
Phadia 100 - User Manual Methods, Test Panels, Article Management Type the article pack size 6.6.1.Add Article (up to five numbers) and press Article Pack Size: 1_ enter to confirm this step. Press enter. 6.6.1.Add Article Bar-code param.1: Press enter.
Page 227: Delete Article
Methods, Test Panels, Article Management Phadia 100 - User Manual Type the new article pack 6.6.2.Edit Article size over the old one (up to five Article Pack Size: 4_ characters) and confirm this step with enter. Press enter. 6.6.2.Edit Article Bar-code param.1:...
Page 228: Create Instrument Event Log
Phadia 100 - User Manual Methods, Test Panels, Article Management 6.11.3.Create Instrument Event Log Use this function at troubleshooting, when you need to create an instrument event log on a USB memory, an external USB hard drive or a diskette.
Page 229 Methods, Test Panels, Article Management Phadia 100 - User Manual MEDIA FULL, ABORT? The USB memory, external USB hard drive or diskette is full. Delete old files or change media. Press no to overwrite data or press yes to abort.
Page 230 Phadia 100 - User Manual Printouts Chapter 10 - Printouts This chapter describes printouts and results as they are listed by the instrument Description of All Printouts Request List Consumption List Distribution List Laboratory Report Patient Report Calibrators Quality Control Log...
Page 231 Printouts Phadia 100 - User Manual Description of All Printouts In this chapter you will find all the reports and lists that can be printed from the instrument. Each printout is described in detail together with a copy of the printout.
Page 232 Phadia 100 - User Manual Printouts Request List The request list contains all the unknown sample identities and their requested tests from the latest prepared assay run. To print this list select 1.2.Print Lists, REQUEST option on the instrument. REQUEST LIST...
Page 233 Printouts Phadia 100 - User Manual Consumption List The consumption list contains all the components with the amounts needed in the prepared assay run. To print this list select 1.2.Print Lists, CONSUMP option on the instrument. CONSUMPTION LIST Run sequence number...
Page 234 Phadia 100 - User Manual Printouts Distribution List This printout lists the components and where they are placed in the instrument. To print this list select 1.2.Print Lists, DISTR option on the instrument. Run origin: Instrument The run was created...
Page 235 Printouts Phadia 100 - User Manual Laboratory Report The laboratory report contains the results from one assay run. It is automati- cally printed after an assay run has been processed. It can also be printed for any stored assay run by selecting 3.2.2.Specific Run or 3.2.3.Specific Run, select Calibrators.
Page 236 Phadia 100 - User Manual Printouts CURVE DATA Expected dose and slope are only printed if calculation type is other ITEM--------VALUE than cut-off ED-20 9.00 ED-50 27.0 ED-80 57.8 Slope Response (RU) 100000 10000 Graphic image of the calibration curve. If a point is rejected, it will...
Page 237 Printouts Phadia 100 - User Manual QUALITY CONTROLS Quality Controls: Quality Control within NAME----RESP--%CV--CONC--%CV-JUDGED Identity of the QC sample limits HIGH Quality Control above 1465 3.60 limit (t3) Response value for each QC repli- LOW Quality Control below cate limit 2050 4.75...
Page 238 Phadia 100 - User Manual Printouts At the end of the laboratory report Lot Information will be printed. All registered bar-codes will be written next to all reagents and samples. If a bar- code reader is not used there will be an empty line were the lot numbers can be filled in by hand.
Page 239 Printouts Phadia 100 - User Manual Patient Report The patient report lists the results for one patient. To get this printout select 3.1.1.All Samples in a Run or 3.1.2.Specific Sample on the instrument. You can customize the patient report in 6.4.System Parameters as follows: •...
Page 240 Phadia 100 - User Manual Printouts Calibrators This printout lists the data of one stored calibration curve. If the calculation type is other than cut-off, the calibration curve graph is also printed along with some curve quality coefficients. To print this list select 4.3.1.Specific Calibrators.
Page 241 Printouts Phadia 100 - User Manual CALIBRATOR DATA NAME-----CONC--RESP--%CV--CALC--%CV Identity of the calibrator point Coefficient of variation of re- CAL-0.00 0.001 0.00 sponses 0.00 Nominal concentration of calibra- mean 0.0 0.00 tor point Calculated concentration of each replicate and the mean value CAL-0.35...
Page 242 Phadia 100 - User Manual Printouts Quality Control Log This printout lists the data logged for one Quality Control point and a graph of the logged data. To print the Quality Control log select 4.1.1.Quality control- log on the instrument. The latest 100 logs are stored.
Page 243 Printouts Phadia 100 - User Manual Example of Quality Control for EliA test: QUALITY CONTROL Method name Elia IgG Identity of the QC Identity: ANA Pos sy Test name of the QC LOG DATA RUN DATE, TIME---LOT NO--CAL CODE--LIMIT-JUDGE Calibration code of used conju-...
Page 244 Phadia 100 - User Manual Printouts Curve Control Log This printout lists the data logged for one curve control and a graph of the logged data. To print the Curve Control log select 4.1.2.Curve control-log on the instrument. The latest 100 logs are stored.
Page 245 Printouts Phadia 100 - User Manual Run Summary This printout lists processed runs stored in the instrument, with date and time for assay run, methods, calibration code and mode. To print the Run Summary select 3.2.1.Summary of Runs on the instrument.
Page 246: Maintenance
Phadia 100 - User Manual Printouts Action List The instrument will automatically print this list every time a Preparation Error occurs. Action Lists can also be included in Laboratory Reports, FluoroC Run Reports and Bland Reports if errors have occured. For more information about Action Lists, see chapter 12, Error Handling.
Page 247: Error Handling
Printouts Phadia 100 - User Manual FluoroC Run Report A FluoroC Run Report is printed when FluoroC is run from 6.9.3.FluoroC. For more information on how to run FluoroC, see chapter 11, Maintenance. FLUOROC RUN FluoroC voltage and mean value...
Page 248 Phadia 100 - User Manual Printouts Method Setup All the method data can be printed for each method defined in the system. To print the method data select the option 5.4.2.Specific Method or 5.4.3.All Methods on the instrument. For USA; the methods ImmunoCAP ECP and ImmunoCAP Specific IgG4 are for investigational use only.
Page 249 Printouts Phadia 100 - User Manual Number of days before a flagged calibration curve turns NOT OK. 0 CALIBRATORS Number of days until the calibra- means that the function is inacti- tion curve is too old vated Test name: a_IgE...
Page 250 Phadia 100 - User Manual Printouts Alternative scoring method for samples CUT-OFF 2 Text below lowest: LIMIT----------TEXT ABOVE LIMIT----- Limits for classes of sample re- sponse, calculated as percentage 65.0 of the lowest calibrator point 90.0 150.0 360.0 960.0 Dilution method: 4000.0...
Page 251 Printouts Phadia 100 - User Manual P a g e 1 0 . 2 2 12-3501-20/12...
Page 252 Phadia 100 - User Manual Maintenance Chapter 11 - Maintenance This chapter describes the maintenance of Phadia 100 Maintenance Daily Maintenance Daily Rinse Emptying of the Waste Bottle Emptying of ImmunoCAP Waste Container Cleaning of the Processing Chamber Weekly Maintenance...
Page 253: Maintenance
WARNING! Phadia 100 pipettes human body fluids, which might be infected. When servicing and maintaining Phadia 100, take precautions to avoid direct contact with parts that have been in contact with samples. Wear protective gloves! P a g e 1 1 .
Page 254: Daily Maintenance
Daily Rinse Daily rinse is done in order to prevent from blockage, growth and carry over. Perform it at the end of each day you have used Phadia 100. Disconnect the Washing Solution Bottle by using the quick release. Replace the Washing Solution Bottle with a beaker filled with approximately 300 ml purified water.
Page 255: Emptying Of The Waste Bottle
Phadia 100 - User Manual Emptying of the Waste Bottle Empty the Waste Bottle to prevent owerflow and contamination. WARNING! Phadia 100 Waste Bottle collects waste liquids containing human body fluids, which might be infected. When emptying and cleaning the Waste Bottle, take precautions to avoid direct contact with the liquids.
Page 256 NOTE! Before closing the Processing Lid, check that the wash rake is well above the ImmunoCAP Carousel, otherwise it might break something inside. The wash rake can be moved manually. WARNING! Phadia 100 processing chamber is exposed to human body fluids, which might be infected. When servicing and maintaining Phadia...
Page 257: Weekly Maintenance
This can cause problems with insufficient distribution of Washing and Rinse Solutions due to twisted tubings inside the instrument. Fill the Washing Solution and Rinse Solution Bottles with approximately 300 ml purified water and connect them to Phadia 100. Also connect the Waste Bottle to the instrument. In Maintenance mode 6.9.Maintenance...
Page 258: Monthly Maintenance
Please read and follow the warnings and instructions carefully. Monthly Maintenance is also used as a corrective action, see Action List. Monthly Maintenance Procedure A cleaning of Phadia 100 has to be done once a month. When handling Maintenance Solution protective gloves should be used. In Maintenance mode 6.9.Maintenance...
Page 259 Maintenance Phadia 100 - User Manual Add 1 ml of antifoam in 6.9.2.Monthly Maintenance the Waste Bottle. Press the LOAD WASTE WITH ANTIFOAM enter key to confirm this step. Fill the empty Rinse Solu- 6.9.2.Monthly Maintenance tion, Washing Solution and...
Page 260: Lubrication Of O-Rings
Phadia 100 - User Manual Maintenance Disconnect and empty the MONTHLY MAINTENANCE WASH Washing Solution, Rinse Solu- CLEAN PROCESS CHAMBER/EMPTY ALL BOTTLES tion and Waste Bottle. Press enter to confirm this step. NOTE! Do not unscrew the caps from the bottles if the tubings are still connected.
Page 261: Cleaning Of The Sample Carousel
Restart the instrument to maintain a good performance of the internal harddisk. For Phadia 100 Ver.3.0, use the menu 6.13.Shutdown and follow the instruc- tions displayed to safely shut down the instrument. Switch Phadia 100 off, wait 10 seconds and switch the instrument on again.
Page 262: Semiannual Maintenance
Phadia 100 - User Manual Maintenance Semiannual Maintenance The following points are included in the semiannual maintenance: • Replacement of the Wash and Rinse tubings • Replacement of the Drainage Filter. In Maintenance mode 6.9.Maintenance press the number 8 key.
Page 263: Replace Drainage Filter
Maintenance Phadia 100 - User Manual Replace Drainage Filter At the bottom of the Processing Chamber there is a drainage filter (12-3500-75) that prevents particles from entering valves. It is advisable to replace it every six months. Press lid open and open the Processing Lid.
Page 264: Unscheduled Maintenance
For Phadia 100 Ver.3.0, use the menu 6.13.Shutdown and follow the instruc- tions displayed to safely shut down the instrument. Before switching Phadia 100 off for longer than a month a daily maintenance has to be processed twice. The first rinse has to run with purified water, followed by a run without any liquid at all.
Page 265 Maintenance Phadia 100 - User Manual Press the yes key. Phadia 100 Ver.3.0 07:55:06 6.Install/Service? In Install/Service mode 6.Install/Service select the number 9 key. 1.Login/Logout? Press the yes key. 6.Install/Service 9.Maintenance? In Maintenance mode se- 6.9.Maintenance lect the number 6 key.
Page 266: Blank Run
Phadia 100 - User Manual Maintenance Example of a Blank Report: BLANK REPORT Run date, time: 090513 11:13 Source: Other Reagent Blank: 14.2 RU Rinse Blank: 12.3 RU Dark Blank: 7.9 RU 00847,090513 11:13, 2.3, 032 Blank Run The Blank Run checks the cuvette and reagents. The Blank Run is included in 6.9.6.Run Selftest.
Page 267 Maintenance Phadia 100 - User Manual In the Maintenance mode 6.9.Maintenance select the number 5 key. 1.Daily Maintenance? Press the yes key. 6.9.Maintenance 5.Run Blanks? Press the enter key to start 6.9.5.Run Blanks the Blank Run. PRESS ENTER TO START A BLANK CHECK Load the Development 6.9.5.Run Blanks...
Page 268 Phadia 100 - User Manual Maintenance FluoroC Run The FluoroC run is used for service and trouble shooting, and checks the performance of the fluorometer. To run FluoroC you need FluoroC Solution and Stop Solution. The FluoroC vial must be at room temperature before the run. Use only new FluoroC vials in each run.
Page 269: Fluoroc Run
Maintenance Phadia 100 - User Manual If the displayed target value is to be used, press the enter key. If a new target value is to be entered, type the value and press the enter key. Confirm the new target value by typing it again and pressing the enter key.
Page 270: Load Printer Paper
Phadia 100 - User Manual Maintenance Load Printer Paper Turn the instrument on. Open the printer lid and take out the old paper roll. View from above with Printer lid open Take new Printer Paper (ArtNo.12-3501-05). Cut the end of the new paper roll to form an arrow.
Page 271: Replace Fuses
Close the cover. Connect the mains power cord. NOTE! Phadia 100 must only be connected to a grounded power outlet (protective ground). P a g e 1 1 . 2 0 12-3501-20/12...
Page 272: Replace Broken Bottle Holders On The Sample Carousel
Place a new fuse in the fuse holder and install it in the instrument. Connect the mains power cord. NOTE! Phadia 100 must only be connected to a grounded power outlet (protective ground). Replace broken Bottle Holders on the Sample Carousel Push the Bottle holder back towards the edge of the Sample Carousel.
Page 273: Replace Broken Tube Holders On The Sample Carousel
Maintenance Phadia 100 - User Manual Press it downwards until it is in position. Be careful not to break the holder at the front of the Bottle holder (marked by being encircled in Fig. 2). Fig.2 Replace broken Tube Holders on the Sample Carousel Unscrew the center screw.
Page 274 Phadia 100 - User Manual Maintenance Place the upper part of the Sample Carousel upside down on a table. Fig. 7. Fig.7 Put the Tube holder guide that you removed from inside the Sample Carousel bowl, on top of the upper part of the Sample Carousel.
Page 275: System Rinse
Maintenance Phadia 100 - User Manual 6.9.4.System Rinse A completed assay run ends with a System Rinse automatically. If the process have been aborted by a processing error, you have to perform 6.9.4.System Rinse. Make sure that there is enough Rinse and space in the Waste Bottle (it normally should if it was enough at the start of the assay run).
Page 276: Log For Maintenance
Phadia 100 - User Manual Maintenance Log for Maintenance Please, copy this form and make a note every time you perform maintenance. Date Action Signature 12-3501-20/12 Page 11.25...
Page 277 Maintenance Phadia 100 - User Manual P a g e 1 1 . 2 6 12-3501-20/12...
Page 278 Phadia 100 - User Manual Error Handling Chapter 12 - Error Handling This chapter describes different error cases and how they are eliminated Introduction Start Up Errors and Start Up Warnings Start Up Errors Start Up Warnings Operator Interaction Messages...
Page 279 Phadia 100 is done carefully according to chapter 11, Maintenance, and reagents are handled according to chapter 3, Reagent and Sample Handling. There are six types of errors: • Start up errors and warnings • Operator interaction messages •...
Page 280 Start switching Phadia 100 off, wait 10 seconds and switch the instrument on again. If the error returns make a note of the error code and contact your local Phadia representative. Example of a start up error: STARTUP ERROR #1201 Startup was aborted.
Page 281 Phadia 100 - User Manual Operator Interaction Messages These types of messages can be shown when operating Phadia 100 using the keyboard. Common sources of problems are disk access, that a specific file on the harddisk cannot be read or written or that there is a problem accessing the USB memory, external USB hard drive or diskette.
Page 282 These errors can occur with error codes between 001-002 and 101-611. For Phadia 100 Ver.3.0, use the menu 6.13.Shutdown and follow the instructions displayed to safely shut down the instrument. Switch Phadia 100 off, wait 10 seconds and switch it on again.
Page 283 Error Handling Phadia 100 - User Manual Preparation Errors These errors may occur during the preparation of an assay run. An Action List with short instructions will be printed every time a message is displayed. Example of a preparation error: 1.3.Load and Start...
Page 284 Phadia 100 - User Manual Error Handling PROCESSING LID IS NOT LOCKED What can cause the problem: Processing Lid is not locked. Corrective actions: Make sure that the Processing Lid is locked properly. ImmunoCAP CAROUSEL IS NOT PRESENT Place the ImmunoCAP Carousel in the Processing Chamber.
Page 285 Error Handling Phadia 100 - User Manual EliA WELL NOT DISPENSED #n What can cause the problem: The instrument cannot detect an EliA Well in the specified position. Corrective actions: Follow instructions in Action List in order to identify or eliminate the errors.
Page 286 Phadia 100 - User Manual Error Handling TEMPERATURE SENSORS DIFFER What can cause the problem: There is a difference in temperature between the sensors in the upper and lower parts of the instrument. Corrective actions: Follow instructions in Action List in order to identify or eliminate the errors.
Page 287 Error Handling Phadia 100 - User Manual Corrective actions: Follow instructions in Action List in order to identify or eliminate the errors. Ensure that Washing Solution and Rinse Solution are properly prepared. The Washing Solution Concentration is of big importance for several tests. Always prepare according to Directions for Use.
Page 288 Phadia 100 - User Manual Error Handling Example of a blank report: BLANK REPORT Run date, time: 090507 10:00 Source: Before Assay Reagent Blank: 13.5 RU Rinse Blank: 11.7 RU Dark Blank: 9.4 RU REMARKS The Blank Check errors are printed...
Page 289 Error Handling Phadia 100 - User Manual NORMAL VALUES For ImmunoCAP between 10 - 20 RU and for EliA between 15 - 35 RU. Corrective actions: Follow instructions in Action List in order to identify or eliminate the errors. Clean and dry (not with Paper tissue) Elution Wells Disc, see Chapter 11, Cleaning of the process chamber.
Page 290 Phadia 100 - User Manual Error Handling Ensure that Washing Solution and Rinse Solution are properly prepared. The Washing Solution Concentration is of big importance for several tests. Always prepare according to Directions for Use. Always use purified water when preparing Washing Solution and Rinse Solution.
Page 291: Index
Error Handling Phadia 100 - User Manual Processing Errors Processing Errors may occur during processing of the assay run. The amount of Processing Errors and the affected positions in the ImmunoCAP Carousel are printed underneath PROCESS ERRORS on the Laboratory Report. You find a list of the errors underneath ERROR LIST.
Page 292 Phadia 100 - User Manual Error Handling Example of an Error List and an Action List printed at the end of a Laboratory Report: A question mark (?) is printed on the Laboratory Report indicating that a Processing Error has occured for the calibrator, curve control, Quality Control or sample.
Page 293 Error Handling Phadia 100 - User Manual 09 32418 Sample 10 33279 Sample The position in the Sample Car- 11 34703 Sample ousel in which the component 12 34703 Empty Instr 10 involved in the error is placed. The position in the ImmunoCAP...
Page 294 Phadia 100 - User Manual Error Handling General explanation of abbreviations XX: Indicate sub-code number Stepper Motor table: XX.x1 Pipette Z Motor XX.x2 Pipette R Motor XX.x3 Pipette Pump Motor XX.x4 Fluorometer Motor XX.x5 ImmunoCAP Carousel Motor XX.x6 Sample Carousel Motor XX.x7 Wash Rake Motor...
Page 295 Error Handling Phadia 100 - User Manual nn: Indicates ImmunoCAP/EliA Well position time: Tells you Number of seconds the incubation has been exceeded with Z: Pipette motor, up and down movement Sometimes Z [nnn] is displayed together with the error message. [nnn] indicates the position of pipette.
Page 296 Phadia 100 - User Manual Error Handling FATAL #03.00 SPURIOUS NMI INTERRUPT What can cause the problem: This error is caused by an external disturbance or it has occurred an error in the electronics. The assay run is aborted. Corrective actions: Follow instructions in Action List in order to identify or eliminate the errors.
Page 297 Error Handling Phadia 100 - User Manual Corrective actions: A solution to this problem can be to install an uninterruptable power supply unit (UPS). [time] FATAL #10.XX-12.XX INC EXCEEDED WITH What can cause the problem: This message occurs when one of the incubations has been too long. There are...
Page 298 Corrective actions: For Phadia 100 Ver.3.0, use the menu 6.13.Shutdown and follow the instruc- tions displayed to safely shut down the instrument. Switch Phadia 100 off, wait 10 seconds and switch on again. Follow instructions in Action List in order to identify or eliminate the errors.
Page 299 Corrective actions: For Phadia 100 Ver.3.0, use the menu 6.13.Shutdown and follow the instruc- tions displayed to safely shut down the instrument. Switch Phadia 100 off, wait 10 seconds and switch on again. Follow instructions in Action List in order to identify or eliminate the errors.
Page 300 Check/remove if the movement of the Sample Carousel has been obstructed. Make sure that nothing is blocking the movement by rotating the Sample Carousel. Switch the Phadia 100 off, wait 10 seconds and switch on again. Clean under the sample carousel if needed.
Page 301 Error Handling Phadia 100 - User Manual #17.09 Contact your local Phadia representative. FATAL #18.00 Position: [nn] ABORTED The operator has aborted the processing. #24.XX CAN'T POS FLAG One of the motors does not seem to work due to an electronical or mechanical malfunction.
Page 302 Check/remove if the movement of the Sample Carousel has been obstructed. Make sure that nothing is blocking the movement by rotating the Sample Carousel. For Phadia 100 Ver.3.0, use the menu 6.13.Shutdown and follow the instructions displayed to safely shut down the instrument. Switch the Phadia 100 off, wait 10 seconds and switch on again.
Page 303 Error Handling Phadia 100 - User Manual FATAL #24.07 WASH RAKE MOTOR CAN'T POS FLAG What can cause the problem: The Wash Rake motor does not seem to work. Make sure that nothing is blocking the up and down movement of the Wash Rake.
Page 304 Phadia 100 - User Manual Error Handling Caused by: Wrong positioning of tube or reagent vial. Touching the pipette arm. Sample Carousel Cover in wrong position. Pipette Wash Position 25.9x (x=1,2) For x see Stepper Motor table. Caused by: Something blocking the Wash Position.
Page 305 Error Handling Phadia 100 - User Manual [nn] #28.XX Position: CANNOT LEAVE FLUID Sub code see Pipette R- position table. What can cause the problem: The level detector detects fluid when it is not supposed to. A droplet of fluid may be stuck between the electrodes and the pipette aspirates air.
Page 306 Phadia 100 - User Manual Error Handling #31.XX Position: [nn] CANNOT FIND CONJUGATE What can cause the problem: This error indicates that the conjugate vial may be out of fluid. The pipette goes to the bottom of the vial and aspirates. Then it continues with the next position.
Page 307 Error Handling Phadia 100 - User Manual [nn] #33.XX Position: CANNOT FIND STOP SOL What can cause the problem: This error indicates that the stop solution vial may be out of fluid. The pipette goes to the bottom of the vial and aspirates. Then it continues with the next position.
Page 308 Phadia 100 - User Manual Error Handling FATAL #36.00 NO LIQUID FOUND What can cause the problem: This error indicates that the vial of Maintenance Solution may be out of fluid. The pipette goes to the bottom of the vial and aspirates. The pipette might not have aspirated the correct volume.
Page 309 Error Handling Phadia 100 - User Manual [nn] FATAL #40.00 Position: DILUENT VIAL/TUBE EMPTY What can cause the problem: The level detector has detected fluid before aspiration but not afterwards when it is leaving the diluent vial or tube. This warning indicates that the diluent vial or tube may be out of fluid.
Page 310 Phadia 100 - User Manual Error Handling [nn] #43.00 Position: STOP SOLUTION VIAL EMPTY What can cause the problem: The level detector has detected fluid before aspiration but not afterwards when it is leaving the stop solution vial. This warning indicates that the stop solution vial may be out of fluid.
Page 311 Check/remove if the movement of the Sample Carousel has been obstructed. Make sure that nothing is blocking the movement by rotating the Sample Carousel. For Phadia 100 Ver.3.0, use the menu 6.13.Shutdown and follow the instructions displayed to safely shut down the instrument. Switch the Phadia 100 off, wait 10 seconds and switch on again.
Page 312 Phadia 100 - User Manual Error Handling #51.XX LAMP VOLTAGE TOO HIGH What can cause the problem: The lamp voltage is too high. This error might be caused by a defect fuse or the lamp beeing too old. Depending on the sub-code different actions have to be taken: WARN #51.00...
Page 313 For Phadia 100 Ver.3.0, use the menu 6.13.Shutdown and follow the instruc- tions displayed to safely shut down the instrument. Switch Phadia 100 off, wait 10 seconds and switch it on again. Rerun the results that have not been reported.
Page 314 Phadia 100 - User Manual Error Handling Assay Result Errors Assay Result Errors may occur during the processing of an assay run. They are divided into six different groups: Calibration Curve Errors Curve Control Errors Quality Control Errors Blank Errors...
Page 315 Error Handling Phadia 100 - User Manual CALIBRATION INFORMATION Calibration number: 23 Run date, time: 090507 16:15 Acceptance of the calibration Calibration code: 1P curve used: Acceptance: NOT OK Calculation type: Rodbard 4-parameters Calibration curve The Calibration Curve Errors are...
Page 316 Phadia 100 - User Manual Error Handling NAME---------RESP----REMARK--------- Estimated and rejected response values are printed here. CAL-15.0 1126 Estimated CAL-15.0 15721 Rejected CAL-15.0 16048 Rejected Example from a Laboratory Report: For further information regarding the Calibration Curve assay, see chapter 7, Monthly Calibration, and regarding the Laboratory Report, see chapter 10, Printouts.
Page 317 Error Handling Phadia 100 - User Manual FLAT CALIBRATION CURVE! What can cause the problem: No Washing Solution going to the Wash Rake. For EliA, wrong Lot Specific Code, no Washing Concentrate in Washing Solution or contamination prob- lems (most likely contamination of conjugate with sample).
Page 318 Phadia 100 - User Manual Error Handling ImmunoCAP Specific IgG, ImmunoCAP Specific IgG4 and EliA, contamination problems. Corrective actions: Follow instructions in Action List in order to identify or eliminate the errors. For additional information see Explanation of Actions, number 7, 22, 24, 38.
Page 319 Error Handling Phadia 100 - User Manual Example from a Laboratory Report: OK, HIGH*, LOW*, HIGH or LOW The Curve Control Error is printed is printed here CURVE CONTROLS here NAME----RESP--%CV--CONC--%CV--JUDGED CC-1 4696 0.51 HIGH CC-2 0.096 CALIBRATION CURVE IS NOT OK...
Page 320 Phadia 100 - User Manual Error Handling Corrective actions: Follow instructions in Action List in order to identify or eliminate the errors. For additional information see Explanation of Actions, number 7, 18, 24, 25, 26, 27. If the error remains contact your local Phadia representative.
Page 321 Error Handling Phadia 100 - User Manual Specific IgE Curve Controls. Corrective actions: Follow instructions in Action List in order to identify or eliminate the errors. For additional information see Explanation of Actions, number 4, 7, 18, 22, 24, 25, 26, 29.
Page 322 Phadia 100 - User Manual Error Handling Corrective actions: No corrective actions proposed. If the error remains contact your local Phadia representative. CC-1 HIGH* and CC-2 HIGH* What can cause the problem: This error might be caused by improper placement of the instrument, but the results might be acceptable.
Page 323 Error Handling Phadia 100 - User Manual Corrective actions: No corrective actions proposed, except for EliA methods. Follow instructions in Action List in order to identify or eliminate the errors. For additional information see Explanation of Actions, number 7, 18, 24.
Page 324 Phadia 100 - User Manual Error Handling CC-1 LOW* and CC-2 HIGH What can cause the problem: This error is very uncommon and is probably caused by more than one error. Corrective actions: Follow instructions in Action List in order to identify or eliminate the errors.
Page 325 Error Handling Phadia 100 - User Manual Example from a Laboratory Report: QUALITY CONTROLS OK, HIGH or LOW is printed here NAME----RESP--%CV--CONC--%CV--JUDGED 0.46 L O W (t3) 0.45 (d1) NAME----EXP CONC--S--LIMIT--MIN--MAX 5.00 0.00 3.0 2.70 6.30 0.00 0.00 1.0 2.00 5.00...
Page 326 Phadia 100 - User Manual Error Handling Corrective actions: No corrective actions proposed in Action List, except for EliA methods. Follow instructions in Action List in order to identify or eliminate the errors. For additional information see Explanation of Actions, number 7, 17, 25, 26, 29.
Page 327 Error Handling Phadia 100 - User Manual REAGENT BLANK IS TOO HIGH If the Reagent blank is >187.5 RU this error message will occur. What can cause the problem: This error might be caused by contamination of the Development Solution or the Elution Wells Disc might need cleaning.
Page 328 Phadia 100 - User Manual Error Handling DARK BLANK IS TOO HIGH If the Dark blank is >15.625 RU this error will occur. Normal values 5 - 10 RU What can cause the problem: This error might be caused by too much light in the Processing Chamber.
Page 329 Error Handling Phadia 100 - User Manual Example from a Laboratory Report: SAMPLES -TEST---RESP---CONC---CLASS---QUOT-- LOW RU is printed instead of the response. No results are pre- 32418 sented ImmunoCAP Specific IgE (kUA/l) LOW RU --.-- ---- 33279 ImmunoCAP Specific IgE (kUA/l) 1591 7.09...
Page 330 Phadia 100 - User Manual Error Handling If the error remains contact your local Phadia representative. Low RU, Whole carousel What can cause the problem: Cuvette broken. Missed pipetting because no Rinse Solution available or no Conjugate, Development Solution or Stop Solution loaded. Stop Solution loaded instead of Washing Solution Concentrate or Washing Solution Additive instead of Development Solution.
Page 331 Error Handling Phadia 100 - User Manual Example of a FluoroC Run Report: FLUOROC The Measurement status can be OK or NOT OK Run date, time: 090507 9:57 Measurement status: OK Target value: DW (12500 RU) RESULTS------------Value--Acceptance The FluoroC %CV can be OK or FluoroC voltage 1: 3923.0 mV...
Page 332 Phadia 100 - User Manual Error Handling FluoroC %CV: NOT OK If you get NOT OK after FluoroC %CV on the FluoroC Run Report the instrument might have run out of FluoroC solution during the FluoroC run or there might be a problem with the pipette.
Page 333 Make sure that nothing is blocking the movement by rotating the Sample Carousel. For Phadia 100 Ver.3.0, use the menu 6.13.Shutdown and follow the instructions displayed to safely shut down the instrument. Switch Phadia 100 off, wait 10 seconds and switch on again. Clean under the sample carousel if needed.
Page 334 Phadia 100 - User Manual Error Handling been recapped. Check that the tubings to the bottle filters are connected properly. See Chapter 11, Semiannual Maintenance. 7 7 7 7 7 Check Wash/Rinse: Consumption, Tubings:Connections and that they are not twisted Make sure that the tubing from the Washing and Rinse Solution bottles are not twisted and that the tubings are properly connected to the bottles.
Page 335 Error Handling Phadia 100 - User Manual problems when there has been ImmunoCAP Dispense errors. Always check that no misplaced ImmunoCAP/EliA Well is in the Processing Chamber after this error message. Always empty the ImmunoCAP Waste Container after every run.
Page 336 Phadia 100 - User Manual Error Handling 20 20 20 20 Empty instrument manually and run Monthly Maintenance Unload Sample Carousel, open Processing lid and lift up ImmunoCAP holder disc. Throw away ImmunoCAP or EliA Wells. Check that no ImmunoCAP or EliA Wells are left in or under the Elution Wells Disc.
Page 337 Error Handling Phadia 100 - User Manual 28 28 28 28 If the error remains, perform Monthly Maintenance It is essential to have a clean instrument for good performance and accepted results.This should be done even if Monthly Maintenance has been done recently on regular basis.
Page 338 Phadia 100 - User Manual Error Handling 36 36 36 36 Check if Washing Solution is loaded Shake Washing Solution bottle gently. The bottle with Washing Solution will foam. Make sure bottle connection is ok. 37 37 37 37 Check that Rinse Solution is loaded in Rinse bottle...
Page 339 Phadia representative. No Power On If you switch Phadia 100 on and the power LED to the right of the display is not lit up, check that the mains power cord is connected and that the cord is undamaged. Connect or replace the cord if necessary.
Page 340 If you do not receive a printout, check that the instrument has not run out of paper. Load a new paper roll if necessary, see chapter 11, Maintenance. If there is paper in the printer switch Phadia 100 off, wait 10 seconds and switch it on again.
Page 341 Error Handling Phadia 100 - User Manual P a g e 1 2 . 6 4 12-3501-20/12...
Page 342 Phadia 100 - User Manual Repacking Chapter 13 - Repacking This chapter describes the cleaning report and the repacking instructions Repacking Cleaning Report Phadia 100 Cleaning Report Repacking Instructions 12-3501-20/12 Page 13.1...
Page 343 Cleaning Report In order to obtain a good safety against transmission of infectious diseases, please make a copy of the cleaning report and fill it in every time you send Phadia 100 to another operator or to Phadia AB. The cleaning report shows the receiver that Phadia 100 was cleaned according to the manual before it was repackaged and transported.
Page 344 Phadia 100 - User Manual Repacking Repacking Instructions Take out the ImmunoCAP Waste Con- Make sure the Washing Solution, Rinse Solution and tainer from the Processing Chamber. Empty Waste Bottles are empty. it and put it in the accessory box.
Page 345 Repacking Phadia 100 - User Manual Fasten the Cleaning Lift the instrument by Report on the instrument the carrying handles and with tape. Put the plastic place it on the bottom plate cover over the instrument. of the plywood box.
Page 346 Phadia 100 - User Manual Accessories Chapter 14 - Accessories This chapter notes the different accessories, spare parts and supplement products to Phadia 100 Accessories for Maintenance Spare Parts Supplement Products Barcode Reader 12-3501-20/12 Page 14.1...
Page 347 12-3500-94 Barcode Reader A barcode reader can be connected to Phadia 100. The barcode reader must be able to read codes 39 and 93, be of RS-232 type, have its own power supply, send decoded data as ASCII-text followed by CR (carriage return) and LF (line feed), and it must be CE-marked.
Page 348 Phadia 100 - User Manual Index Chapter 15 - Index 12-3501-20/12 Page 15.1...
Page 349 Index Phadia 100 - User Manual Bottle Cleaning 11.6 Abort Rinse Solution Prepared Run 4.39 Washing Solution Process 4.44 ACCESS DENIED 12.5 Waste Accessories 14.2 Accessory Box 1.15 1.16 Accuracy Calibration Code 2.31 Pipette volume 1.10 2.45 1.10 Washing solution Calibration Curve Error 12.37...
Page 350 Phadia 100 - User Manual Index CAP TRANSFER MOTOR Communication Error 12.61 CAN'T FIND FLAG 12.23 Communication Parameters 1.25 CAN'T POS FLAG 12.25 Conjugate Handling NOT CALIBRATED 12.20 NOT INITIALIZED 12.20 CONJUGATE VIAL EMPTY 12.31 OUT OF RANGE 12.23 Consumption List 10.4...
Page 351 Index Phadia 100 - User Manual Default Method 1.22 Electrical Safety Classification 1.11 Delete ImmunoCAP 100E 1.11 Article 9.36 UniCAP 100 1.11 Calibrators Electro Magnetic Compatibility Method 9.25 Request Data 4.40 ImmunoCAP 100E 1.11 Sample ID UniCAP 100 1.11 Test 4.18...
Page 352 Phadia 100 - User Manual Index Calibration Curve 12.37 Curve Control 12.41 FluoroC 12.53 LOW RU 12.51 2.31 Quality Control 12.47 ImmunoCAP 1.12 Error Messages 2.30 Evaporation Remove 4.41 Remove All 4.43 Export Skip Loading 4.36 Calibrators 6.14 ImmunoCAP 100 2.30...
Page 353 Index Phadia 100 - User Manual Instrument Performance Mechanical Malfunction 12.61 Verification 2.16 MEDIA Intended Use ERROR 12.4 FULL 12.4 Interface NOT INSERTED 12.4 INTERNAL ERROR 12.10 WRITE-PROTECTED 12.4 Menu Structure Messages Laboratory Report 10.6 12.4 Print Method LAMP VOLTAGE TOO HIGH 12.7...
Page 354 Phadia 100 - User Manual Index Operation 2.32 PRESSURE TOO LOW 12.7 12.33 OUT OF RANGE 12.23 Primary Fuses Replacement 11.20 Specification Password Print Change 1.24 All Samples 1.24 Calibrators Patient Report 10.10 Curve Control Log Print Laboratory Report PC Remote 10.3...
Page 355 Index Phadia 100 - User Manual Coefficient of variance Remove Limit response 4.28 EliA Well 4.43 Edit 4.25 ImmunoCAP 4.43 Expected concentration 4.28 Repacking 13.2 Expected standard deviation 4.29 Replicate Handling Change Identity 4.26 Instrument dilution factor 4.33 Request Internal...
Page 356 Phadia 100 - User Manual Index Sample Tubes Dead volumes Specifications TCP/IP connector Secondary Fuses Replacement 11.21 1.10 Specification Technical Specification Select New Method Temperature Select Quality Control 4.10 TEMPERATURE SENSORS DIFFER 12.9 Selftest 11.13 Test Semiannual Maintenance 11.11 4.15 Service 1.11...
Page 357 Index Phadia 100 - User Manual Washing Solution Bottle Warm-Up Time Cleaning 11.6 Warnings 2.34 Waste Bottle Wash Rake Cleaning 11.6 WASH RAKE MOTOR Emptying 11.4 CAN'T FIND FLAG 12.23 Waste Container CAN'T POS FLAG 12.25 Emptying 11.4 NOT CALIBRATED 12.20...

Thermo Scientific Phadia 100 User Manual

Table of Contents

Chapter 4 - Assay Run Editing Functions

2 Data Evaluation 2

Chapter 6 - Assay Run Quality Control

Chapter 8 - Quality Assurance

Chapter 9 - Methods, Test Panels, Article Management

2 Maintenance 2

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Chapters

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Table of Contents