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Instruction Manual

1. walho Contains the options 4 4 pl X to define the number Pipetting Coord Y nord of wells and their Order Caption rom 1110 mmi Well Color Function positions on the 1 125 100 Round 50 50 Color undefined slide Select the 2 2 125 200 5050 Color undefined well created in the 3 IE 125 300 Round50x50 Color undefined well designer 4 4 d25 Round 50550 J Color undefined color optional 5 125 En Round5050 undefined function optional 6 E 125 600 Round50x50 Color undefined and the substrate Slide Info Manufacturer Color HelMed Instruction Manual Vers 3 0 2008 12 05 To add a Manufacturer right click the mouse on the arrow A window will open Press the plus button You will get an Untitled line in which the name of the manufacturer can be added To delete a manufacturer follow the same procedure but select the manufacturer to delete with a mouse click and press the minus button The manufacturer will be deleted Bd ItemListEditorForm _ Name Im Im AESKU DIAGNOSTICS _ Biosystems 2 Genetic Assays Immcao
2. INOVA 00 MeDiCa Mame LIntilled Use the Color button to select the color of the slide The thickness of the slide can be adjusted using the Thickness field oet the width of the slide by selecting 25mm or 26 mm option I Helmed IFA Slide Designer Slide Info Slide Tools Slide Info Manufacturer AESKU DIAGNOSTICS eaa Thickness 1 10 mm i Manufacturer AESKU DIAGNOSTICS Width y Calor Thickness 1 10 mm 25mm 26mm BEI EE NES ERE eee 4 2 5 Text Info The X and Y positions define the upper left position where the text begins Enter the text in the field Measure the distance from the left edge of the slide to the right edge of the text in ANA HEp2 millimetres Multiply by 10 and enter the value in the X Coord 1 10mm position Measure the distance from the upper front edge of the slide to the top edge of the text in millimetres Multiply by 10 and enter the value in the Y Coord position 1 10mm Texts can be placed left to right bottom to top top to bottom Orientation field HelMed Instruction Manual Vers 3 0 2008 12 05 El cU Text Info 14 4 a vane gt Coord Size Index Caption I jaa new PLA mm Fant Color Orientation 0 2 125 35 30 Arial LeftToRight LN 90 35 Arial Color
3. 2008 12 05 NOTE AESKU tests are pre programmed and should not be edited The Test designer has the flexibility to program most IFA assays The parameters of these assays should be based on the instruction manual contained within the kit It is the responsibility of the user to make proper adjustments and then validate the test before use MiHelmed1FA Select the Tools option at the top of the Helmed IFA Main re _ E m ocreen a Select Test designer from the drop down menu to open the Test Designer screen Select the Test option at the top of the Test Designer Main Helmed IFA Test Designer Screen quem Select New from the drop down menu to create a new test There are two Info fields listed in the Test Designer 5 1 Test Info 9 2 Steps Mew Test Strg h Open Test StrgT o 5 1 Settings for Test Info Select the Manufacturer the Substrate the Well the Slide and Wash type that should be used in the test by using the drop down menu on every line The function Allow Well Pooling is for using different conjugates on one slide For IFA assays requiring incubation s higher than room temperature 23C 25C the Test Run Temperature can be adjusted However the specialized carrousel with the heating specification must be used The standard carrousel will not work hy Helmed IFA Test Designer Test Test Ino NOTE The Test Designer Main Sc
4. File Took te n Slide Designer Test Designer Prime Instrument Change Rack Layout Bar Code Reader Scan Rack Layout Before Run Enable Back Light 2 Select your instrument Prime Instrument Step 1 of 2 Instruments Instrument HelMed Instruction Manual Vers 3 0 2008 12 05 3 Number of cycles Prime Instrument Step 2 of 2 8 2 Weekly maintenance Prime the instrument once a week with 0 3 Sodium Hydrochlorite NaOCl solution Follow the steps from 8 1 to prime instrument Attention After cleaning the instrument with Sodium Hydrochlorite NaOCI solution it is necessary to prime the instrument with distilled water three times with nine cycles each Follow procedure 8 1 to prime instrument 9 Calibration Only trained personnel is allowed to calibrate the carrousels and the peristaltic wash pump For calibrating the wash pump you need the special calibration tube Part No M094 4 Detailed procedures are in the Service Manual
5. LeftTaFRight H 4 2 6 Well Info well Info 14 4 e von dB X Caption EER once Well Color Function Substrate m 125 100 Round50x50 Mj Color undefined E 2 2 125 200 50 50 Color undefined Liver g 3 3 125 300 Round 5050 Color undefined Liver B 4 4 125 400 Round 50550 Color undefined 7 Liver E 5 5 125 500 50 50 Color undefined B Liver 5 F E 4125 B00 5050 J Color undefined Liver B Numbers of wells are defined by pushing the plus button in the Well Info field Complete the Caption column by numbering the wells continuously Wells can also be removed by the minus button se x 4 Loog oord Coord nord 1110 0 mmi 1 710 mm Delete bn 126 TAM Well positions are defined by measuring from the designated front and left edges of the slide to the center of the well A ruler for X and Y positioning is shown on _ the screen The 0 0 axis is in the upper left corner 1 i 2 Measure the X position of the first well in millimetres using a metric 8 3 ruler The X position is the distance from the left edge of the slide to the center of the well Multiply the distance measured by 10 Enter the 5 4 value into the X COORD 1 10 mm field 5 Measure the Y position of the first well in millimetres using a metric ruler The Y position is the distance from the upper front edge of the slide to
6. Pumps One peristaltic pump for aspiration of fluids One peristaltic pump for slide well and MTP well washing 1 x 50 uL syringe 1 x 1 mL syringe Precision CV lt 3 5uL CV lt 1 10 uL Plate washer 1 channel Power consumption 210 W Fuse T4A 250V 5x20mm Ceramic breaking capacity 1 500 V Voltage range Input 115 240 Volt 50 60 Hz Output 24 Volt DC 5 Volt DC Operating Temperature 20 35 C 10 90 non conducting Weight 28 Kg HelMed Instruction Manual Vers 3 0 2008 12 05 8 0 Maintenance The daily maintenance is important for the proper operation of the instrument The following procedure is recommended We recommend to calibrate the carrousels during the yearly maintenance Only trained lab personnel is it allowed to calibrate the instrument To calibrate the peristaltic wash pump please look at section 3 3 of the Service Manual 8 1 Daily Shutdown After a finished worklist the instrument has to be primed with distilled water This keeps the fluid lines in good condition and avoid particles in the needle and the tubings Replace wash solution with distilled water Empty the wash bottle 1 and fill it with distilled water or disconnect the quick connector on the bottle top and use a new bottle with distilled water Prime the instrument 1 Select Tools from the IFA Main Screen Then select Prime Instrument Helmed IFA __ E
7. screen Helmed IFA 1 File Contains options for creating a new work list to open a work list already processed to close one all work list s to print the preview to save the work list and to exit the program 2 Tools Contains the modules for the slide designer and the test designer It also contains the order to prime the instrument scan the rack layout switch on off the barcode reader and the backlight and the function to scan rack layout before run 3 Help Contains the information on the IFA software version and the contact for the manufacturer 41 File There are 9 options given in the file menu 1 New Helmed IFA Allows the user to create a new work list for Strg h MM Open Strgro 2 Open Allows the user to open a previously saved work list file of a run 3 Close Close all To close one all work list s 4 Save Save as To save a programmed work list file and to give it a name 5 Print Print Preview To print the work list of the programmed run 6 EXIT To leave the Helmed IFA program 4 2 Tools There are seven options listed in the tools menu i Helmed IFA Ce is en 3 Site ume eR p le BENE Help Weri ore HelMed Instruction Manual Vers 3 0 2008 12 05 1 Slide designer Opens the Slide Designer screen Contains the Well Designer Module Refer to section 4 2 1 for details of the Slide Designer screen 2 Test designer Open
8. the center of the well Multiply the distance measured by 10 8 6 Enter the value into the Y COORD 1 10 mm field x Repeat these steps for all other wells on the slide 17 HelMed Instruction Manual Vers 3 0 2008 12 05 Select a Well using the drop down menu in the Well column The Well has been defined and previously saved in the Well Designer Refer to section 4 2 2 for further information Funt Using the color column the well can be colored Grundtarberr mi wl Functian undefined undefined To define a function for a well position i e the position of a calibrator select gt the drop down menu of the function column Select a Substrate by using the drop down menu in the Substrate column oubstrates can be added by a right mouse click on the arrow A window will open Press the plus button to get an Untitled line in which the name of an additional Substrate can be added Saving the slide design Once the slide is defined with all information needed it has to be saved 1 Select Slide from the Slide Designer Screen 2 Select Save as from the drop down menu 3 Enter a slide name and select Save The slide will be saved in the Helmed IFA Software 5 Test Designer The Test Designer is used to create a new test or to change settings of an existing test if required Refer to section 4 2 1 for details on creating a new slide 18 HelMed Instruction Manual Vers 3 0
9. Do not place the equipment out of doors Do not place the equipment on a surface of flammable material Do not place the equipment so that it is difficult to access for maintenance or servicing Do not block air openings Do not place the equipment where it could get wet Do not position the equipment so that it is difficult to operate the mains disconnecting switch Do not let the equipment or its flexible cord come into contact with surfaces that are too hot to touch Check that the nominal voltage shown on the equipment matches the supply voltage Check for a horizontal work surface Avoid to adjoin and to swinging the instrument during the operation 1 1 2 Accessories 1 x HelMed Unit 1 x Power Cord Schuko German 1 x Fuse Power switch 1 x USB Cable 1xWash 1 Bottle with Tube 1xWash 2 Bottle with Tube 1 xWaste Bottle with Tube 1 x Reagent Rack Standard 2 x Sample Racks 1 50 and 51 100 1 x Calibration Tube 1 x Starter Kit includes 50 x 4 ml empty vials caps 50 x 20 ml empty vials caps 4 x Uncoated Nunc MTP Also included Software CD with latest Software version Instruction manual and Service manual Printed Version of the Instruction manual 1 2 Unpacking the HelMed The HelMed equipment normally ships in an industrial strength cardboard box set ona pallet Remove the upper part of the cardboard box Remove all boxes of the accessories Place the instrument in its designated area Open t
10. HelMed Instruction Manual Vers 3 0 2008 12 05 AESKU SYSTEMS AESKU SYSTEMS e K The Diagnostic Automation Company Mikroforum Ring 3 55234 Wendelsheim Germany Instruction Manual IFA 1 Helmed Installation HelMed Instruction Manual Vers 3 0 2008 12 05 Table of Contents Introduction Theory of operation 1 1 Installation Requirements 1 1 2 Accessories 1 2 Unpacking the Equipment 1 2 1 Placing the Helmed in its designated area 1 3 Installing the Helmed amp 1 3 1 Connectors on the instrument 1 4 Connecting the Helmed Warning Labels 1 5 Replacing the fuse on main power inlet Helmed Software 21 Requirements 22 Software Installation 23 Software structure Accessories 3 1 IFA Module Software Overview 4 1 Files 4 2 Tools 4 2 1 Slide Designer 4 2 2 Tools 4 2 3 Slide 4 2 4 Slide Info 4 2 5 Text Info 4 2 6 Well Info 5 Test Designer 5 1 Settings for Test Info 5 2 Settings for Steps Helmed Instrument Version 1 0 Ne L Il Il 2 1 2 1 2 1 D 45 bi DN gt 4 ume HelMed Instruction Manual Vers 3 0 2008 12 05 6 Run a Worklist 6 1 7 General Specifications 7 1 8 Maintenance 8 1 8 1 Daily shut down procedure 8 1 8 2 Weekly shut down procedure 8 1 9 Calibration 9 1 9 1 Only trained personnel is allowed to calibrate the carrousels and the peris
11. STEMS LKS 8w SHORT HEp2 12w IMMMC O monkey heart Bw IMMC O monkey heart SHORT IMMCO_Skeletal_ HelMed Instruction Manual Vers 3 0 2008 12 05 2 New Worklist Step 3 of 5 shows the selected test New VWorklist Step of 5 Selected Test AESKU_ANA HEp2 12w 51 100 5 Selected test is stated The slide that belongs to the selected test is shown in the drop down Use the Side drop down menu in the MODE line Mode Add Another Test to select between doing screening or titration of the samples Enable the Add another test button let the user come back to New worklist Step 2 of 5 to add additional tests Press NEXT 3 Using Barcode labeld samples the barcode reader has to be enable before creating a new worklist M Helmed IFA File Em Slide Designer Test Designer Prime Instrument Change Rack Layout Bar Code Reader Scan Rack Layout Before Run Enable Back Light 4 New worklist Step 5 of 5 New YvYorklist Step 5 of 5 The following worklist will be configured Instrument HelMMediti Select Tools from the HelMed IFA main screen Enable the Barcode reader in the drop down menu The barcodes of the samples and the racks as well will be scanned in New Worklist Step 4 of 5 otandard sample tubes are 5 ml tube 13 x 75mm New VWorklist Step 4 of 5 Please place all of the sample tubes on t
12. code reader Fill in the Sample ID Click all samples and dilutions that should be processed in the run Y Helmed IFA Y Helmed IFA S IPS IF 1520 oe EXIT n me rr me Pe ETC ad EA nra ma Sal Sa Sa 0 da e it o it eet et amp 3 zl sz C NNN N CN exl Feet Fen Es PR T E ES a L LG L LS zie am epo SES e 3 ga ag alaa E el e e E e e E cte ag 5 2131231512121 9 3 3 m Z2 Z zZ z z oF 0 lt I Cr Lj Lj Lj Lu 2 A eR t xc xc ox Rack Pasition Sample Id S S 3 S B S e 5 5 8 5 8 1 21 1 d Rack Position Sample Id Pa eene 2 22 2 a po ECCE C AE 3 23 3 2 22 2 e 24 a m 23 3 ooooooo ooo 5 25 n p e n oooooooo oo MTP shows how many strips are needed for the pre dilution steps Y Helmed IFA Status Status gives the information about the action Y Helmed IFA Layout Sample Data MTP a Ga ean a starting the Worklist to run a program 29 HelMed Instruction Manual Vers 3 0 2008 12 05 After all slides reagents controls and samples are loaded return to the Status option on the top of the Workl
13. e with a circular well It is possible to set multiple dispensing points in this module recommended for slides with large wells Y Helmed IFA Well Designer Well Info Well Preview XSize 1 10 mm YSize 1 10 mm Dispense Points 4 gt 8 x HelMed Instruction Manual Vers 3 0 2008 12 05 4 2 3 Slide The Slide Designer is used to modify an existing slide layout or to define new slides for additional assays that will be run using the Helmed IFA Module NOTE AESKU slides are pre programmed and should not be edited The Slide Designer has the flexibility to program most IFA slides It is the responsibility of the user to make proper adjustments if needed and to verify the slide designer settings prior to use This section will describe how to design a new slide NOTE The Slide Designer Main Screen will open a default slide file This slide has to be changed There are three Info fields listed in the Slide Designer 1 Slide Info Contains options to select the Helmed IFA Slide Designer Slide Into m manufacturer color Color Cater Thickness 1 10 mm 25mm O 26mm and width Fettin 4 4 vni bk bl oP X 2 Text Info The Text option can Index Caption Coord Size Font Color fimm 1210 mm 110mm C be used to place text DENN 50 50 50 8 ona slide 3 Well Info
14. er minute of the volumetric pump during dispensing The Aspiration Height is the height of the aspiration needle above the slide when aspirating the fluid If the option Enforce Timing is selected then the Incubation time of the step before the washing will be strictly adhered too Steps After these settings are entered press OK The Washing Step appears under Step on the left side of the screen Dilution Incubatian Wash o M Conjugate Addition If Enforce Timing has been selected the incubation time will be strictly ord adhered to and the Wash Step appears in red fonts 7 As an optional step for IFA you may select Counterstain Addition from the right side of the screen double click or add button Define the Volume needed to cover the entire well The dispensing height is the height of the dispensing needle above the slide when dispensing fluid The dispensing Speed is arbitrary and relates to the revolutions per minute of the volumetric pump during dispensing The Aspiration height is the height of the aspiration needle above the slide when aspirating the fluid Settings such as Volume Dispensing Height Dispensing Speed and Aspiration Height must be verified and validated otep 6 and Step 7 can be combined in a Composite Step The function of this step is to immediately add counterstain to each well after it is washed Select Composite from the right side of the screen Composite appears under Step
15. er should be deleted then select the one to delete with a mouse click and press the minus button The wash buffer will be deleted oelecting Allow Well Pooling uses different conjugates on one well Run Test Temperature can be increased for a special test a special heater carrousel is needed available on request 5 2 Settings for Steps lt Add Select from the list on the right side the steps that should Bener Mh iion be processed in a test There are seven options listed Dilution ounterstain Addition Incubation Wash Conjugate Addition Counterstain Addition m mee Mounting Medium Addition and Composite ove E dit Steps etia Incubation eas Addi Mounting Medi Composite nes The steps to process slides must be defined Selecting Test Steps from the right side of the screen following the instruction manual of the manufacturer NOTE All step files will open with default settings These settings have to be changed before adding to the Step AESKU test steps are pre programmed and should not be edited The following instructions for creating test steps are an example only and refer to the AESKU IFA Kit instruction manual 1 Select Dilution from the right side of the screen double click or add button A window will open in order to define samples controls diluent and dispensing transfer to the slide 1 1 Define the Screening dilutions for the Samples This dil
16. f the screen there are now three Gree a different steps available Wash Conjugate Addition and Counterstain Addition e 3p Select Wash and follow the instructions above The Wash appears under Composite on the left side of the screen E Then select Conjugate Addition and follow the instructions in 4 above o Composite The Conjugate Addition appears under Composite on the left side of o Wash the screen To continue defining Steps click once on Step on the left oniugate ddton side of the screen To continue defining steps click once on Step on the left side of the screen HelMed Instruction Manual Vers 3 0 2008 12 05 5 Select Incubation from the right side of the screen double click or add button and define the Incubation time needed for the Conjugate incubation Then click OK Incubation step appears under Step on the left side of the screen ubation Wash Conju Incubation gate Addition al 6 Select Wash from the right side of the screen double click or add button Define how many cycles a well is required to be washed Settings such as Volume Dispensing Height Dispensing Speed Aspiration Height have to be verified and validated The volume needed to cover the entire well depends on the size of the well The Dispensing Height is the height of the dispensing needle above the slide when dispensing fluid The Dispensing Speed is arbitrary and relates to the revolutions p
17. ght Dispense Speed and Aspirate Height These settings must be verified and validated 4b a gt Aspirate Height 1 10 5 AP of Cycles Volume 1 uL co 4 Volume 2 Volume 3 pL If it is necessary to first wash the wells with Conjugate then the Conjugate number of cycles must be defined Up to three cycles are possible 20 o eo D i 24 ar o 5 e 3 e n3 n3 e e e Dispense Speed 50 For every cycle edit the Volume needed to cover the entire well gt lt v q T T O car ce a Volume 1 uL Volume 2 uL If there is no need for more than one cycle of Conjugate addition then only fill in the ul s needed for Volume 1 After these settings are entered press OK Volume 3 uL ssi The Conjugate Addition step appears under Step on the left side of the Dilution screen Incubation Wash Conjugate Addition Step 3 and Step 4 can be combined in a Composite Step The function of this step is to immediately add conjugate to each well after it is washed SS Select Composite from the right side of the screen Composite Steps Dilution ______ appears under Steps on the left of the screen when this step is Incubation eene ta nabled On the right side of the screen there are now thr enabled On the right side o
18. he green cover and carefully remove the cardboard protections If there are any damages of the cardboard box and or the instrument please contact your local distributor HelMed Instruction Manual Vers 3 0 2008 12 05 1 2 4 Placing the HelMed in its designated area Two people one on each side of the instrument are required to move it once it has been unpacked One hand holds the bottom front of the instrument The other hand holds the bottom back of the instrument This method prevents any tendency for the instrument to tip It should be lifted equally by the two people and set on the designated table 1 3 Installing the HelMed amp First installation should be done by trained people only according to the Service Manual 1 3 1 Connectors on the instrument 1 Fluid lines In the rear of the instrument you have the quick connectors for the wash solutions and for the waste bottle See bottle installation 2 Main power inlet The power inlet is located at the back of the instrument The instrument power cord is plugged into it 3 USB Port The instrument is connected to the PC via a USB cable The USB port necessary for this connection is located at the back of the instrument 4 Bottle Installation The bottles are labeled as follows WASH 1 red WASH 2 blue WASTE black The tubing is correspondingly color coded The quick connectors for the bottles are located at the back of the instrument 5 USB Connection C
19. he instrument then select Next to continue Gives the information about the instrument selected test s for the worklist that will be configured AESKUL 124 51 100 Substrate AESKU_HEp2 Slide AESKU ANA 2_ 12w 51 100 Run Press FINISH to come to the layout Mode Screening screen The worklist layout will open as a default setting with an Info field on the right 2 HelMed Instruction Manual Vers 3 0 2008 12 05 side of the screen containing Test Info Wash Solution Info Reagent Rack Info Slide Info Layout Test Info Number Name Manufacturer AESKU ANA H AESKU DIAGNOSTICS Wash Solution Info Number Name Manufacturer Aesku Wash Bu AESKLI DIAGNOSTICS Reagent Rack Info Rack Rack 12 be Number Position Name e Aesku Cell Diluent 1 AESKU IgG ANA HEp 1 MountingMedium Slide Info Position Name Manufacturer AESKU ANA H AESKU DIAGNOSTICS HelMed Instruction Manual Vers 3 0 2008 12 05 The Layout screen gives the information about where to put the reagents controls samples and slides After all samples are filled in and selected refer to 2 Sample Data by ticking the layout default screen become the real layout screen where the amount of slides needed will be shown Sample Data Sample Data has to be defined Select the plus button to add samples when not using the bar
20. ht of the aspiration needle above the slide when aspirating the fluid Sep 7 tis recommended to select Enforce Timing for the Counterstain Incubation By doing so the incubation time will be strictly adhered nim too Wash Then click OK Wash step appears under Step on the left side of the Conjugate Addition screen Incubation B Composite Wash Counterstain Addition Incubation Wash 10 Select Mounting Medium Addition from the right side of the screen double click or add button Define the settings of the Mounting Medium Addition Volume Dispense Height Dispense Speed and Aspirate Height These settings have to be verified and validated After these settings are programmed press OK Volume Dispense Height 1 10 mm Dispense Speed e n3 oo ce e e Aspirate Height 1 10 mm Steps The Mounting Medium Addition step appears under Step on the left Steps side of the screen Dilution Incubation Wash Conjugate Addition Steps ncubatrinr T NE Selecting Counterstain Addition as an Mounting Medium Addition optional step for IFA an Composite step Wash see the ranking of the steps in the following Conjugate Addition Im ag e Incubation Composite n Wash Counterstain Addition 25 Incubation Wash Mounting Medium Addition HelMed Instruction Manual Vers 3 0 2008 12 05 Saving the Test Once a
21. ist screen and press START Helmed IFA RENI While running the software m depicts two clocks The large clock shows the remaining time of the whole run while the small clock shows the Sample Dilution remaining time of the actual Time remaining 00 01 50 i Started at 00 00 00 action currently taking place Finished at 00 00 00 If needed it is possible to pause the run using the PAUSE button Time remaining 01 13 40 As the system is then N unlocked e g the samples 3 may be removed Press CONTINUE and the run will go on If there is any reagent missing buffers controls conjugates the instrument will give an Irc T alarm beep as well as a red alarm light The system is unlocked during this time and the run is stopped The carrousel will turn to the position where the reagent is missing After refilling the reagent bottle the cover has to be closed Press OK to go on with the run The ERROR report is shown in the status option HelMed Instruction Manual Vers 3 0 2008 12 05 7 0 General and technical Specifications Sample capacity With barcode IFA up to 100 Without barcode IFA up to 150 With barcode EIA up to 120 Without barcode EIA up to 192 Dilution Capacity IFA 192 positions 1 1 to 1 160 one step one well 1 161 to 1 25600 two step two wells EIA 1 1 to 1 101 one step 1 102 to 25000 using a predilution tube
22. ll test steps are defined the test has to be saved 1 Select Test from the Test Designer Screen 2 Select Save from the drop down menu 3 Enter a Test name and select Save The Test will be saved in the Helmed IFA Software 6 Run a Worklist Up to four different tests with four different substrates and four different conjugates are allowed to run on one HelMed Workstation Select the HelMed IFA Software icon on the desktop to open the main screen Select the File option at the top of the HelMed IFA main screen Selecting New from the drop down menu allows the user to create a new worklist Selecting Open from the drop down menu allows the user to open a previously saved work list file of a run A Open StrgT o Dien Erin The following instructions for creating a worklist are an example only and refer to the AESKU IFA ANA Hep2 12w 51 100 Kit Select New from the drop down menu in the file option of the HelMed IFA main screen New worklist Step 1 of 5 will open where all available instruments are shown New Worker Sram Tor 5 Select one instrument of this list and press the Instruments N EXT b utton emo Instrument HelMed 1 HelMed 2 1 Select one of the available tests shown In the next window New worklist Step 2 of 5 by pushing ae aa the Add button and then the NEXT Available Tests Selected Tests b u tto n AESKU hep2 12w green AESKLU hep2 12 orange esku LKS BIOSYSTEMS LKS 8w BIOSY
23. oated cells then they will bind during the first incubation Washing steps will remove any unbound material The bound antibodies are detected by Fluorescein conjugated anti human Immunoglobulins during a second incubation A specific green fluorescent staining of the antigen antibody complex can be visualized by the use of a fluorescent microscope The Helmed IFA software automates the processing of IFA slides For in vitro Diagnostic use only In addition to the main software there are three additional software modules well designer slide designer and test designer The well designer module is used to define the well on a slide size diameter type shape rectangle The slide designer module is used to define the positions of the wells along with the surfaces texts and substrates affixed onto the slide to be processed The test designer module is used to define how a slide should be processed during a run Defined here are the dilution factors for screening or titration the positions of controls and samples on the slide and the steps required for processing Test steps include the volumes needed for transfer to the slide incubation times number of wash cycles volume of wash buffer s counterstain optional and mounting medium dispensing optional HelMed Instruction Manual Vers 3 0 2008 12 05 1 1 Installation requirements The requirements for the site where the equipment is to be installed are the following
24. onnect the instrument to the PC with the provided USB cable HelMed Instruction Manual Vers 3 0 2008 12 05 1 4 Connecting the HelMed Equipment Warning Labels CONNECTING TO THE MAIN ELECTRICAL SUPPLY The HelMed equipment is connected via the socket on the back of the instrument using the supplied power cord Warning Electromagnetic compatibility and electrical safety tests have been performed using the cord supplied by the manufacturer However if it is necessary to use another cord be sure that the new cord meets the following specifications Cable type flexible cable with insulation and PVC cover with 3 conductors neutral live and earth Cord length 2m Connector type For IEC inlet Connector for class appliances Plug type Plug type used in the country where the equipment is installed and with grounded connection Connector cable and plug must comply with the electrical safety requirements applicable in your country It should be remembered that the equipment uses a switched power supply which automatically adapts to the main electrical supply voltage and therefore does not require any type of switching Consult the specifications in order to check the operating margins CAUTION Using cables other than those specified may result in degraded electromagnetic compatibility of the equipment DANGER To avoid the risk of electric shock this equipment must be connected to the main grounded elect
25. reen will open sii with default settings Test Info These settings have S to be changed before starting with the Step Side 7 Wash Allow Well Pooling Test Run Temperature Select a Manufactu rer by USING the drop down menu in the Manufacturer line A Manufacturer s name can be added by a right mouse click on the arrow A window will open Press the plus button to get an Untitled line in which the name of an additional manufacturer can be added lf a Manufacturer should be deleted then select the manufacturer to delete with a mouse click and press the minus button The manufacturer will be deleted Select a Substrate by using the drop down menu in the Substrate line Substrates are defined in the Slide Designer For further information refer to Selection 4 2 6 Select a Well by using the drop down menu in the Well line Wells are defined in the Well Designer Slide Designer Tools For further information refer to Selection 4 2 2 HelMed Instruction Manual Vers 3 0 2008 12 05 Select a Slide by using the drop down menu in the Slide line Slides are defined in the Slide Designer For further information refer to Selection 4 2 1 Select a Wash type by using the drop down menu in the Wash type line Wash types can be added by a right mouse click on the arrow A window will open Press the plus button to get an Untitled line in which the name of an additional wash buffer can be added If a wash buff
26. rical supply 1 5 HelMed Instruction Manual Vers 3 0 2008 12 05 Warning labels on the instrument LN Caution In case of a malfunction of the incubator the labeled Microtiter Plate Holder may be hot AA Caution Do not open the waste container peristaltic pump cover while the pump is rotating The cylinders of the rotating pump may crush your fingers or cause other injury A Caution The waste solution in the two liter waste bottle may contain infectious material Please follow your internal guidelines for biohazard infectious waste disposal According to WEEE 2002 96 EG for a proper disposal of the instrument you have to follow local regulations or return the instrument to the manufacturer Caution Replacing the fuse in the main cable inlet DANGER HelMed Instruction Manual Vers 3 0 2008 12 05 If you need to replace the fuse T4A 250V 5x20mm be sure that the power supply cord is unplugged before opening the fuse cover Do not plug in the power supply cord when the cover for the fuse is open Plug in the power supply cord only after first replacing the fuse and closing the fuse cover THIS PRODUCT IS FOR IN VITRO DIAGNOSTIC USE ONLY Only trained staff specially advised in methods of in vitro diagnostic testing may operate the instrument Although this instrument is not considered toxic or dangerous in conditions of normal use refer to the following for maximum safety Recommendation
27. s and precautions We recommend avoiding contact with eyes and skin and wearing disposable gloves when you are working with human specimens 2 HelMed Software 2 1 PC Requirements Windows XP or Windows Vista Windows 2000 will also work Older systems should comply with the specifications below Both 32bit and 64bit operating systems are fine At least 512 MB RAM At least a 20 GB hard drive Monitor must support a minimum resolution of 1280x1024 PH 2 2 Software Installation Installing the HelMed software Insert the HelMed program installation CD into the computer disk drive Run the installation program with the file HelmedlFASetup xxx exe on the CD Accept the default options and follow the instructions as they are displayed A HelMed Icon will be installed on the desktop amp Helmed IFA Software xxx 3 Accessories 3 1 IFA Module Software Helmed System IFA Software 1 0 HelMed Instruction Manual Vers 3 0 2008 12 05 Hardware Slide Carrousel MTP Carrousel Reagent Rack Sample Racks Bottles and Tubings WASH 1 red including the tubing which is correspondingly color coded WASH 2 blue including the tubing which is correspondingly color coded WASTE black including the tubing which is correspondingly color coded 4 Software Overview IFA Software Main Screen Helmed IFA HelMed Instruction Manual Vers 3 0 2008 12 05 There are three options along the top of the
28. s on the left of the screen Coca cin when this step is enabled On the right side of the screen there are now three different steps available Wash Conjugate Addition and Counterstain Addition Select Wash and follow the instructions in 3 6 HelMed Instruction Manual Vers 3 0 2008 12 05 Sep The Wash appears under Composite on the left side of the screen 5 Steps Then select Counterstain Addition follow the instructions in 7 ium The Counterstain Addition appears under Composite on the left side B of the screen ed To continue defining Steps click once on Step on the left side of the Conjugate Addition screen 8 Select Incubation from the right side of the screen double click or add button and define the incubation time needed for the counterstain incubation Then click OK Incubation step appears under Step on the left side of the screen 9 Select Wash from the right side of the screen double click or add button Define how many wash cycles are required Settings as Volume Dispensing Height Dispensing Speed Aspiration Height have to be verified and validated The volume needed to cover the entire well depends on the size of the well The dispensing height is the height of the dispensing needle above the slide when dispensing fluid The dispensing Speed is arbitrary and relates to the revolutions per minute of the volumetric pump during dispensing The Aspiration height is the heig
29. s the Test Designer screen Refer to section 5 for details of the Test Designer creen 3 Prime Instrument Primes the Instrument with Wash solution Wash 1 Wash 2 at the beginning of a run or as a shut down procedure at the end of a day Slide Designer 4 Change Rack Layout Test Designer Scans the positions of each rack Prime Instrument 5 Bar Code Reader To switch the Barcode reader on off Change Rack Layout Bar Code Reader Scan Rack Layout Before Run 6 Scan Rack Layout before When this function is enabled the rack layout will be scanned before a run Enable Back Light 7 Enable Back Light When this function is enabled the Backlight will work in the different colors each color has a different meaning 4 3 Help There are two options listed in the Help menu My Helmed IFA User manual Contains the User manual as a Pie Tools paf file About Information about the software version 4 2 1 Slide Designer Helmed IFA Slide Designer Test Designer HelMed Instruction Manual Vers 3 0 2008 12 05 First select the Tools option at the top of the Helmed IFA main screen Second select Slide designer from the drop down menu to open the Slide Designer screen The slide must be designed before creating a new test design The Helmed IFA software is pre programmed for AESKU IFA slides but is open to allow the user to define slides
30. size of the well The Dispensing Height is the height of the dispensing needle above the slide when dispensing fluid The Dispensing Speed is arbitrary and relates to the revolutions per minute of the volumetric pump during dispensing The Aspiration Height is the height of the aspiration needle when aspirating the fluid from the slide If the option Enforce Timing is selected then the Incubation Time of the step prior to washing will be strictly adhered too Cycles Volume uL Dispense Height 1 10 mm Dispense Speed uL s Aspirate Height 1 10 mm Enforce Timing A ak emet Prime Needles First Sheps After these settings are entered press OK The washing step appears under Inubai Step on the left side of the screen Wash Steps m If Enforce Timing was selected for the incubation time then the Wash Step Incubation X appears red font Wash oo Wash HelMed Instruction Manual Vers 3 0 2008 12 05 Cs jc 4 Select Conjugate Addition from the C5 right side of the screen double click or c add button Select a conjugate using the drop down menu in Conjugate line Conjugates can be added by a right mouse click on the arrow A window will open Press the plus button to get an Untitled line in which the name of an additional Conjugate can be added as well as its Manufacturer Define the settings for the Conjugate Addition Dispense Hei
31. t and Volume uL x Dispensing Speed c The volume needed to cover the entire well depends on the well size i e Round 50x50 30ul Round 80x80 80yl The Dispensing Height is the dispensing needle height above the slide when dispensing fluid The Dispensing Speed is arbitrary and relates to the revolutions per minute of the volumetric pump during dispensing These Parameters must be verified and validated for the slides Samples Controls Diluent s Dispensing After these settings are entered press OK The first test step appears under Step on the left side of the screen HelMed Instruction Manual Vers 3 0 2008 12 05 2 Select Incubation from the right side of the screen double click or add button and define the incubation time needed for the first incubation Then click OK Stps Incubation step appears under Step on the left side of the screen Steps Dilution lt Incubation a 3 Select Wash from the right side of Meaning Medium ain the screen double click or add button Enter the number of required wash er cycles Volume Dispensing Height Dispensing Speed and Aspiration Height settings have to be verified and validated Cycles Volume pL Dispense Height 1 10 mm Dispense Speed e Aspirate Height 1 10 mm Enforce Timing Prime Needles First The volume needed to cover the entire well depends on the
32. taltic wash pump HelMed Instruction Manual Vers 3 0 2008 12 05 Introduction The Helmed IFA module is the software application for the Helmed system It provides programming options for the processing of IFA slides The system requires the addition of the supplied slide carrousel the reagent rack and the sample rack to accommodate IFA kit components To run the IFA module a complete Helmed system is required The Helmed System consists of the following the Helmed workstation a computer not provided a monitor not provided and a printer not provided Up to ten Helmed workstations may be connected to a single computer The system automates the processing of IFA slides The Helmed IFA software contains AESKU IFA test files but also allows the user to define slides types and test files for other IFA Kits Since the HelMed is evaluated on AESKU IFA Kits AESKU Systems can not take responsibility for processing IFA kits of other manufacturers A fluorescence microscope not provided is required in order to read the slides processed by the Helmed workstation Please follow the instruction of the IVD kit used Theory of Operation The detection of antibodies is based on the principle of indirect immunofluorescence assay Glass microscope slides are coated with tissue sections or cells Hep 2 cells Granulocytes ANCA or Crithidia luciliae nDNA If the patient s serum contains specific antibodies to these c
33. types from any manufacturer There are two options along the top of the screen 1 M Helmed IFA Slide Designer _ 1 Slide c E m Contains options for creating a new slide or to open an existing slide 2 Tools Contains the module of the well designer for creating a new well or to open an existing well 4 2 2 Tools Helmed IFA Slide Designer Slide zaj Tools Well Designer mu i Helmed IFA Well Designer Em 1 New JU Mew Stra To create a new well type Open Strg O 2 Open To open an existing well type 3 Save To quick save a programmed well 4 Save as To save a programmed well as a named well 5 Close To close the well designer and come back to the slide designer Create a new well by filling in the information about type and size X amp Y Size of a well HelMed Instruction Manual Vers 3 0 2008 12 05 ai Helmed IFA Well Designer Helmed IFA Well Designer W ell Info shape Size 1 10 mm Size 1 10 mm Well Info Shape Hound esent Y Size 1 10 mm Measure the size of a circular or rectangular well For circular wells measure the diameter across the center of the well For rectangular wells measure the width and the height of the wells All measurements are in millimetres Multiply the result by 10 and enter the value into the X Coord and the Y Coord field X Coord amp Y Coord must be the sam
34. ution will be used for all patient samples Define the Titration dilutions of interest for the samples as well The titration dilutions are added by clicking the ADD button HelMed Instruction Manual Vers 3 0 2008 12 05 1 2 Define the Controls Add the Controls eT Diluent Dispersing needed with the plus button Select the position default setting undefined Tintin C starts always at the first position of a slide undefined Negative Conti 17 m Edit the names of the controls Select a dilution if needed default setting 1 1 for ready to use controls Select between controls dispensed before first patient or controls dispensed on every slide 1 3 Select the Diluent by using the drop down EE menu of the dilution medium line Select between Dite with Wash Solution and Diluent If Wash Solution is a _ selected then the Wash Buffer of the test will be used If Diluent is selected then the Diluent line will be enabled and the test Diluent will be used A Diluent can be selected by using the drop down menu in this line Diluent types can be added by a right mouse click on the arrow A window will open Press the plus button to get an Untitled line in which the name of an additional Diluent can be added as well as its Manufacturer 1 4 Define the Dispensing settings for the transfer to the slide These settings are divided by Dispensing Volume Dispensing Heigh

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