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QIAsymphony SP/AS Consolidated Operating Guide 12/2017

205

Appendix A

Declaration of Conformity

Declaration of conformity — QIAsymphony SP

Name and address of the company

QIAGEN GmbH
QIAGEN Strasse 1
40724 Hilden
Germany

Declaration of conformity — QIAsymphony AS

Name and address of the company

QIAGEN GmbH
QIAGEN Strasse 1
40724 Hilden
Germany

An up-to-date Declaration of Conformity can be requested from QIAGEN Technical Services.

Содержание QIAsymphony AS

Страница 1: ...Sample to Insight__ December 2017 QIAsymphony SP AS Consolidated Operating Guide For use with software versions 4 0 and 4 1 Version 1 QIAGEN GmbH QIAGEN Strasse 1 40724 Hilden GERMANY R2 1112127...

Страница 2: ...2 1 3 1 Training for QIAsymphony SP AS users 12 1 4 QIAsymphony Cabinet SP AS 12 1 5 User manual references 13 1 6 Glossary 13 1 7 QIAsymphony SP AS accessories 13 2 Safety Information 14 2 1 Proper u...

Страница 3: ...tion settings 29 4 2 User accounts 29 4 2 1 Create new users 30 4 2 2 Activate inactivate user accounts 31 4 2 3 System request for password change 32 4 2 4 User request for password change 33 4 3 Lan...

Страница 4: ...6 6 Deleting files 47 7 QIAsymphony SP Features 48 7 1 Workflow principle 48 7 1 1 Basic principle 49 7 2 Instrument features 49 7 2 1 Magnetic head 49 7 2 2 Lysis station 50 7 2 3 Robotic arm 50 7 3...

Страница 5: ...74 8 5 1 Loading tube carriers 74 8 5 2 Loading the plate carrier 83 8 6 Performing inventory scans SP 83 8 6 1 Inventory scan of the Reagents and Consumables drawer 83 8 6 2 Inventory scan of the Was...

Страница 6: ...101 12 1 3 Run with normalization 101 12 1 4 Standard curve 101 12 2 Preparing a run 102 12 2 1 Assay favorites 102 12 3 Integrated run 103 12 3 1 Defining an integrated run 104 12 3 2 Loading an inte...

Страница 7: ...153 12 5 3 Transfer to a PCR cycler 153 13 Troubleshooting 154 13 1 Error messages and warnings 154 13 1 1 Errors indicated in the status bar 154 13 1 2 Errors indicated in the tab headers 154 13 1 3...

Страница 8: ...definition errors 175 13 7 2 Inventory scan errors 176 13 7 3 Errors occurring during an assay run 177 13 7 4 Data analysis errors 178 13 8 Integrated run errors that do not have error codes 179 13 8...

Страница 9: ...188 14 5 5 Cleaning the optical sensor SP 188 14 5 6 Magnetic head SP 188 14 5 7 Liquid waste container SP 189 14 5 8 Cleaning adapters AS 189 14 6 UV decontamination of the worktable 189 14 7 Mainte...

Страница 10: ...taffed by experienced scientists with extensive practical and theoretical expertise in molecular biology and the use of QIAGEN products If you have any questions or experience any difficulties regardi...

Страница 11: ...SP instrument is designed to perform automated purification of nucleic acids It is intended to be used only in combination with QIAsymphony Kits indicated for use with the QIAsymphony SP for the appl...

Страница 12: ...nce QIAGEN Field Service Specialists only Regularly trained certified and authorized by QIAGEN 1 3 1 Training for QIAsymphony SP AS users Customers are trained by a QIAGEN representative upon installa...

Страница 13: ...hony SP QIAsymphony SP AS User Manual Operating the QIAsymphony AS QIAsymphony Management Console User Manual QIAsymphony Cabinet SP AS User Guide 1 6 Glossary For a glossary of terms used in this con...

Страница 14: ...owing safety conventions are used throughout this consolidated operating guide WARNING The term WARNING is used to inform you about situations that could result in personal injury to other persons Det...

Страница 15: ...SP AS instruments and unplug the power cord from the power outlet 2 2 Electrical safety Important If operation of the instruments is interrupted in any way e g due to interruption of the power supply...

Страница 16: ...perating them and contact QIAGEN Technical Services The instruments may be electrically unsafe when The QIAsymphony SP AS or the line power cord appears to be damaged The QIAsymphony SP AS has been st...

Страница 17: ...ined in publications such as Biosafety in Microbiological and Biomedical Laboratories HHS www cdc gov od ohs biosfty biosfty htm 2 5 1 Samples WARNING Samples containing infectious agents Some samples...

Страница 18: ...logical as defined in the applicable Safety Data Sheets SDSs or OSHA ACGIH or COSHH documents Venting for fumes and disposal of wastes must be in accordance with all national state and local health an...

Страница 19: ...storage systems e g computer discs Do not use metal tools when handling the magnetic rods Do not allow the magnetic rods to come into contact with other magnets CAUTION Damage to the instrument s Mak...

Страница 20: ...disinfectant leave the instrument hoods open to allow flammable vapors to disperse Only clean QIAsymphony SP AS instruments with alcohol based disinfectant when worktable components have cooled down...

Страница 21: ...e QIAsymphony SP AS instruments Only perform maintenance as described in this consolidated operating guide CAUTION Damage to the instrument s Make sure to install the tip guards correctly before opera...

Страница 22: ...to the crushing hazard label on the robotic arm Turn off the UV lamp before opening the lid or for servicing During decontamination the housing must remain closed Avoid looking directly into UV light...

Страница 23: ...of the instrument RCM former C Tick for Australia supplier identification N17965 Type plate on the back of the instrument RoHS mark for China the restriction of the use of certain hazardous substances...

Страница 24: ...temperature fluctuations WARNING Risk of overheating To ensure proper ventilation maintain a minimum clearance of 5 cm 1 97 in at the rear of the QIAsymphony SP AS Slits and openings that ensure the...

Страница 25: ...essing of the current protocol step is finished In some cases this may take some time 3 2 2 Touchscreen The QIAsymphony SP AS is controlled using a swivel mounted touchscreen The touchscreen allows th...

Страница 26: ...work cable 3 2 5 Status LEDs Light emitting diodes LEDs at the front of QIAsymphony SP AS instruments are illuminated when sample preparation or assay setup is in progress The status LEDs flash when a...

Страница 27: ...containers are empty 2 Make sure that all drawers and both hoods are closed If the hood s is opened during instrument startup the system test will fail After successful startup QIAsymphony SP AS inst...

Страница 28: ...he QIAsymphony SP AS instruments press the power switch at the front of the QIAsymphony SP in the lower left corner We recommend switching off the instruments after use Important Do not switch off the...

Страница 29: ...tom configuration profiles In addition the Supervisor can Transfer input and output files process files and most instrument setup files from QIAsymphony SP AS instruments to the USB stick Transfer rac...

Страница 30: ...pervisor password To do this follow the instructions in the touchscreen The Sample Preparation screen will be displayed again The Supervisor user ID is now visible in the status bar on the lower right...

Страница 31: ...eps 1 3 of Section 4 2 1 for more information 2 Press the Tools tab The Tools menu will be displayed 3 Press the User Management button The User overview Please Select User Supervisor login screen app...

Страница 32: ...onfiguration menu in the System 1 tab It is also possible to deactivate the password expiration setting If a password has expired you will be prompted to enter a new password after logging in To chang...

Страница 33: ...r Management The User Overview Your user data screen appears 4 Press Change PWD The User Overview Please enter your new password screen appears 5 Press Old Password text field 6 Enter the old password...

Страница 34: ...ing the USB stick or the QIAGEN Management Console QMC 4 3 1 Setting up the USB stick and transferring language files from the USB stick Add the data translation folder to the USB stick and copy the l...

Страница 35: ...he file transfer tool of the QIAsymphony Management Console QMC version 4 1 and are visible in the respective selections Translation file s have to be located in the root data translation folder 4 3 3...

Страница 36: ...t In Windows 7 the QMC has to be in the Run as Administrator mode To enter this mode right click on QMC Installation Directory bin qClient exe and then select Run as Administrator 1 Select Tools 2 Sel...

Страница 37: ...eparate tables For more detailed information see Section 16 5 1 1 Status bar Batch status icon The batch status icon provides the user with information about each sample batch The color of each tube c...

Страница 38: ...utton is pressed If insufficient consumables and reagents are loaded for the queued batches the R C button becomes yellow and flashes After opening the Consumables Cartridges Filter Tips screen the R...

Страница 39: ...shes yellow In this situation if you press the button a message appears informing the user why it is not possible to start the run 5 1 2 Tab menus The Integrated Run tab is used to Define integrated r...

Страница 40: ...phony SP AS instruments messages may appear that provide the user with general information inform the user that operator input is required or provide information about warnings and errors Each type of...

Страница 41: ...ick downloading Log files Result file SP Result file AS Confirmation files Loading information files Cycler files Instrument report files Rack files Work lists From USB stick to QIAsymphony SP AS inst...

Страница 42: ...only be used for QIAsymphony SP AS data transfer Make sure that the file folder structure of the USB stick is correct and that enough storage space is available Important Do not remove the USB stick...

Страница 43: ...solidated Operating Guide 12 2017 43 3 Press File Transfer in the Tools screen The In Output Files tab of the File Transfer menu opens 4 Select one of the file transfer tabs In Output Files Process Fi...

Страница 44: ...rmation message will be displayed After successful data transfer a message will appear confirming data transfer 8 Remove the USB stick 6 4 Transferring files from the USB stick Important File transfer...

Страница 45: ...the files will be transferred from the USB stick to the QIAsymphony SP AS instruments 8 Press Yes to confirm that the files should be transferred During data transfer an information message will be di...

Страница 46: ...ny SP AS instruments that should be synchronized with the files on the USB stick by pressing the appropriate button s in the Transfer from USB stick panel 6 Set Synchronize files to Yes by pressing th...

Страница 47: ...pressing the Yes button 7 Press the Transfer button in the command bar of the screen to synchronize the selected files A message appears informing you that the files will be synchronized Check that t...

Страница 48: ...the rod covers or not The QIAsymphony SP is preinstalled with various protocols and corresponding Assay Control Sets for purification of RNA genomic DNA and viral and bacterial nucleic acids The user...

Страница 49: ...c particles Sample prep cartridges are positioned below the magnetic rod with its cover The QIAsymphony SP uses a magnetic head containing an array of 24 magnetic rods and can therefore process 24 sam...

Страница 50: ...station a heated orbital shaker enables automated lysis of up to 24 samples in 1 batch After sample lysis the lysis station moves upward so that samples can be transferred for further processing QIAs...

Страница 51: ...pacitive based liquid level detection cLLD and pressure based liquid level detection pLLD To detect the liquid level changes in capacitance or pressure between the disposable filter tip and the liquid...

Страница 52: ...with bar codes tubes containing small volumes of liquid or clear liquids may not be detected In this case use a blank bar code label to enable detection of the sample tube For more information refer...

Страница 53: ...o tubes refer to Appendix A of the QIAsymphony SP AS User Manual General Description 7 3 4 Handheld scanner The handheld scanner may be connected via USB connection to one of the USB ports of the QIAs...

Страница 54: ...drawer 8 1 Using the software Wizard The QIAsymphony SP operating software offers a Wizard that provides step by step guidance for setting up a run The Wizard takes you through Loading the Waste drawe...

Страница 55: ...nstruction for loading QIAsymphony drawers 8 2 Loading the Waste drawer Used 8 Rod Covers and sample prep cartridges are discarded by the robotic gripper into the Waste drawer and are collected in 4 u...

Страница 56: ...ep To load the tip park station into the Waste drawer follow the steps below 1 Open the Waste drawer 2 Ensure that the tip park station is properly inserted otherwise an error may occur during the inv...

Страница 57: ...nt If using the QIAsymphony SP instrument with the QIAsymphony Cabinet SP refer to the QIAsymphony Cabinet SP AS User Guide for information about setup of the tip chutes The tip chute will be detected...

Страница 58: ...er will vary To load the Waste drawer with unit boxes follow the steps below 1 Remove the lid from the unit box 2 If the unit box contains a spacer make sure to remove this 3 Place the unit box into o...

Страница 59: ...d to cover partially filled unit boxes 8 2 6 Closing the Waste drawer After preparing the Waste drawer the drawer must be closed to initiate the inventory scan 8 3 Loading the Eluate drawer 8 3 1 Feat...

Страница 60: ...hnical reasons 96 well elution racks cannot be used on Elution slot 4 Adapters Adapters are available for the following types of consumables Microplate round bottom Sarstedt screw cap tubes 2 ml PCR p...

Страница 61: ...that you want to add a rack to 5 If the elution rack is bar code labeled scan the bar code using the handheld scanner Alternatively press Rack ID and enter the elution rack ID manually using the Keybo...

Страница 62: ...you are using an Elution Microtube Rack EMTR scan the bar code of the rack and the elution rack type will be automatically selected by the QIAsymphony SP Important If the elution rack was used in a p...

Страница 63: ...elution racks can be automatically transferred from the QIAsymphony SP via the transfer module to slot 2 of the Eluate and Reagents drawer of the QIAsymphony AS instrument The transfer frame consists...

Страница 64: ...tegrated run mode an elution rack on Elution slot 1 will be automatically transferred from the QIAsymphony SP to the AS module to start the reaction setup Afterwards the elution rack will be automatic...

Страница 65: ...e downloaded using the QIAsymphony Management Console or via file transfer from the QIAsymphony SP to the USB stick For a detailed description of how to manually remove elution racks see the following...

Страница 66: ...ppears 8 Press OK The QIAsymphony SP performs an inventory scan of the Eluate drawer Afterwards the Sample Preparation Overview screen is displayed Important If eluate cooling in Elution slot 1 was tu...

Страница 67: ...it box and keep for later use Lids can be used to reclose partially used unit boxes 2 Place unit boxes containing either unused 8 Rod Covers or sample prep cartridges into the Reagents and Consumables...

Страница 68: ...maximum of twelve 8 Rod Covers There is a spacer between the bottom of the unit box and the last 8 Rod Cover A specific pattern on the top and bottom edge of an 8 Rod Cover enables automatic detectio...

Страница 69: ...p rack slots Tip racks can be placed in any of the slots since rack position tip type and number of tips are detected during the inventory scan The number of tips required per sample varies depending...

Страница 70: ...rst vortexes the magnetic particle trough and then removes the seal from the magnetic particle trough 2 Remove the lids from the tubes and place into the appropriate slot to prevent mix up 3 When the...

Страница 71: ...The composition of the reagent cartridge is kit specific Do not mix troughs from different kits Visually check all reagent troughs for precipitates If precipitates are present refer to the handbook o...

Страница 72: ...s additional ethanol this must be poured by the user into an Accessory Trough which is then placed into either tip rack slot 5 or 12 These slots can be used for either tip racks or Accessory Troughs I...

Страница 73: ...d store according to the instructions in the kit handbook The reagent cartridge holder can then be used in combination with other kits Store the enzyme rack according to the instructions in the kit ha...

Страница 74: ...for collection of used sample prep cartridges and 8 Rod Covers in the Waste drawer 8 5 Loading the Sample drawer Samples can be loaded into the Sample drawer in either primary or secondary tubes For m...

Страница 75: ...tube carrier If a tube is used that is not the default tube type for a certain insert the user must specify the tube type when defining the sample batch Default tubes can also be configured Inserting...

Страница 76: ...ide 12 2017 76 Examples of slot status LED illumination 2 Gently slide the tube carrier into the appropriate slot Insert up to the stop line and wait until the bar code reader has moved forward Slidin...

Страница 77: ...es in different slots follow procedure as described in this section Otherwise close the Sample drawer Important Be sure to support the tube carrier with your second hand during the loading process Oth...

Страница 78: ...ded that the consumables drawer is fully loaded before commencing the first batch After loading the samples the system allows the user to correct bar code reading errors change labware assign Assay Co...

Страница 79: ...Assigning an Assay Control Set to a sample not only specifies which protocol should be used but also which internal control should be added to the sample The QIAsymphony SP supports the use of interna...

Страница 80: ...nter information about the internal control 1 Press the IC button to check or modify the internal controls The Internal Controls screen appears 2 Select the position that needs an internal control to...

Страница 81: ...n internal control or it was manually assigned to a particular position in the fifth tube carrier These internal controls are listed under the category In use Important If the internal control was lab...

Страница 82: ...in Slot A the internal controls can be unloaded Remove the carrier with internal controls from Slot A by gently sliding it out of the Sample drawer The status of the internal controls changes from LO...

Страница 83: ...able can be scanned The inventory scan is drawer specific This means that only the drawer that has been opened will be scanned for changes 8 6 1 Inventory scan of the Reagents and Consumables drawer T...

Страница 84: ...d are scanned to determine the number of tips If a tip is detected in the first and last position of the tip rack the tip rack will be categorized as full If the first or last tip is missing a full sc...

Страница 85: ...orm a partial inventory scan 8 6 2 Inventory scan of the Waste drawer The inventory scan of the Waste drawer consists of a laser scan It does not perform 2D bar code scans liquid level detection or ch...

Страница 86: ...ter bar code specified in the labware file are different A bar code is detected but the selected labware file does not specify an adapter bar code No bar code is detected but the selected labware file...

Страница 87: ...stopped Other batches with the status QUEUED can be processed in another run after following the cleanup procedure If the run is stopped all processed samples are flagged with invalid It is not possi...

Страница 88: ...ired for the next sample batch Seal the troughs with Reuse Seal Strips and store according to the instructions in the kit handbook 8 9 End of working day 1 Empty the liquid waste container 2 Unload th...

Страница 89: ...ich the sample type shall be changed by pressing the corresponding buttons 3 Press EC or EC to change the sample type from Sample to positive extraction control EC or negative extraction control EC Im...

Страница 90: ...ed in the tube carrier Assigning different Assay Control Sets to a sample batch To assign samples to a batch follow the steps in sections Without work list or With work list below Without work list 1...

Страница 91: ...vailable Assay Control Sets for the selected application 5 Select the Assay Control Set that should be used with the selected samples 6 As soon as the first Assay Control Set has been selected only As...

Страница 92: ...nish the batch definition workflow With work list 1 If all sample tubes have been correctly identified and if there are no unidentified samples or duplicate entries depends on the software configurati...

Страница 93: ...e compatible with the selected work list are displayed in the list of available work lists Important To deselect a work list select it in the Selected Work Lists field and then press the arrow button...

Страница 94: ...for the batch to be defined by pressing the corresponding slot button 8 To overwrite the default elution volume select the required elution volume from the list by pressing the appropriate button Use...

Страница 95: ...or a defined run e g number and type of filter tips volume of reagent An automated inventory scan performed when the drawers are closed or before an assay run starts ensures that each drawer is correc...

Страница 96: ...ransfer positions Tip waste Input adapters Eluate and Reagents drawer PCR output adapters Assays drawer Disposable tips Robotic arm 10 2 1 QIAsymphony AS hood During an assay run the QIAsymphony AS ho...

Страница 97: ...or occurs Touching the screen turns off the flashing 10 2 3 Robotic arm This feature is the same as for the QIAsymphony SP except it does not support a robotic gripper The QIAsymphony AS pipettor head...

Страница 98: ...s Adapters are available for the following types of consumables 96 well plates Microplates Sarstedt screw cap tubes PCR plates Elution Microtubes CL cat no 19588 For more information about the types o...

Страница 99: ...s case slots 4 6 must be covered with the Rotor Disc Adapter Base Unit QS and up to 2 Rotor Disc 72 Loading Blocks A Rotor Disc 72 can then be placed onto each Rotor Disc 72 Loading Block Important As...

Страница 100: ...the QIAsymphony AS at the same time where neither run influences the other It is also possible to perform an independent run on the QIAsymphony SP and then transfer eluates via the transfer module to...

Страница 101: ...QIAsymphony AS can perform a normalization step i e eluates of known concentration are diluted to target concentrations before assay setup This option is available for most assay definitions in combin...

Страница 102: ...ction 6 12 2 1 Assay favorites In the integrated mode personalized assay favorites can be defined for quicker assignment within the setup screen for Integrated Operation 1 Press the Tools tab and sele...

Страница 103: ...grated Run user interface 5 Load the QIAsymphony SP Waste drawer 6 Load the Eluate drawer with the correct rack inside the corresponding cooling adapter together with the transfer frame on Elution slo...

Страница 104: ...thawed If desired enter a kit bar code for each assay 22 Load disposable filter tips into the Eluate and Reagents and Assays drawers Load at least the required number of each tip type 23 Close the Elu...

Страница 105: ...ut solving the problem The Integrated Setup screen provides an overview of the defined batches and or allows batches to be defined To define a batch follow the steps below 1 Select the batch button an...

Страница 106: ...SP batches can be processed in one AS batch To define an integrated batch follow the steps below 1 Load a tube carrier The loaded batch is displayed on the touchscreen 2 Assign assays to sample positi...

Страница 107: ...These will be shown in light blue before selection and darker blue after selection 5 Alternatively select all the samples by pressing Select All 6 Select the desired assay from the Assays list The se...

Страница 108: ...e changed using the touchscreen Important It is not possible to modify assays in work list mode 1 Press the Specification button The Assay Specifications screen will appear 2 Select the assays for whi...

Страница 109: ...side of the screen by pressing the appropriate button 8 Press OK to save the changes and to return to the Assay Assignment screen Important If the parameters are modified the changes will not be save...

Страница 110: ...n AS batch follow the steps below 1 In the integrated setup Overview screen press one or more SP batches to select them 2 When selected the batch button s will change to gray 3 Press the Create AS Bat...

Страница 111: ...om the default press the IC Tubes button and select a tube type 5 Select an internal control from the Internal controls list The selected internal control will be assigned to the selected loaded inter...

Страница 112: ...tch from the integrated run of the related SP batch This button is unavailable if the AS batch has been started 3 The Edit Samples button allows bar code reading errors for sample tubes to be resolved...

Страница 113: ...portant At least one assay has to be assigned to samples of the QIAsymphony SP batch Important This action can also be performed for completed QIAsymphony SP batches allowing automated assay setup of...

Страница 114: ...n also use the arrows to select a position When Sample is pressed the sample ID sample type status and sample volume are displayed as well as the assay to which this sample has been assigned To view i...

Страница 115: ...sample ID sample type status and volume are displayed as well as the assay to which this sample has been assigned To view information about all of the positions in the assay rack in tabular format pr...

Страница 116: ...en press the first Assay slot to be loaded highlighted yellow Detailed loading information for the slot is shown 3 Assign rack type and rack ID For details see this section Assigning assay racks or th...

Страница 117: ...ly be changed to an assay rack that uses the same adapter type If Assay Parameter Sets have been assigned that have different default rack types no rack type will be specified in the corresponding ass...

Страница 118: ...lly enter an assay rack ID Alternatively use the bar code scanner to enter a rack ID The entered assay rack ID will appear in the corresponding Assay slot If a rack type has already been assigned to t...

Страница 119: ...gent adapter with reagents follow the steps below 1 Open the Eluate and Reagents drawer 2 In the Assay Setup Loading information screen press the first Reagents slot shown in yellow The detailed loadi...

Страница 120: ...ayed in the table 6 To view loading information about all reagents for a particular assay press List View 7 Select different assay tabs to see reagent information for the different assays To view reag...

Страница 121: ...code using the bar code scanner 5 Press OK to return to the Loading Reagents screen If the bar code scanner was used the Loading Reagents screen will automatically reappear 6 The software validates th...

Страница 122: ...ding disposable filter tips Up to 6 tip racks can be placed in the Eluate and Reagents drawer and the Assays drawer i e a total of 12 tip racks Tip rack position tip type and number of tips are detect...

Страница 123: ...tip racks will be identified during the inventory scan 12 3 3 Checking cooling temperatures Cooling temperatures are shown in an overview screen Press the Cooling button in the Loading information scr...

Страница 124: ...button to the left of the cooling position to be switched off The snowflake button will appear gray Important When a Rotor Disc is assigned as an assay rack slots 4 6 are covered with the Rotor Disc A...

Страница 125: ...lots Cooling for the eluate rack s is also switched off at this point In an integrated run the eluate rack is moved back to the QIAsymphony SP and is cooled there 4 Open the Assays drawer and the Elua...

Страница 126: ...and stopping an integrated run Pausing a QIAsymphony SP or a QIAsymphony AS run A run on the QIAsymphony SP or the QIAsymphony AS can be paused by pressing the Pause SP or Pause AS button in the Integ...

Страница 127: ...ony AS run is paused press the Stop SP or Stop AS button to stop the integrated run On pressing Stop SP all batches currently being processed will be stopped although AS batches previously started wil...

Страница 128: ...slot This cannot be changed Slot 2 is automatically preselected in the Sample Rack s screen and is highlighted dark yellow Slot 1 is by default defined as a Reagents slot If required slot 1 can be red...

Страница 129: ...he steps below 1 Press a Sample slot to select it A selected Sample slot is highlighted dark yellow 2 Select a rack type from the Select rack type list The selected rack type will be assigned to the s...

Страница 130: ...n to the Sample Rack s screen The entered rack ID will appear If a rack type has already been assigned to the Sample slot the slot will now appear blue Automatically assigning a sample rack ID 1 Selec...

Страница 131: ...rack files Sample Racks and Assay Racks Sample Racks are standard sample rack files for defining an assay run In some cases the assay rack can be used as a sample rack e g for setting up two step RT...

Страница 132: ...e additional sample positions If rack file s were not assigned sample positions control positions and volumes must be manually defined When a rack file has not been assigned it is also possible to edi...

Страница 133: ...volume of eluate Selecting positions in the sample rack Before samples controls and volumes can be defined positions in the sample rack must be selected To select individual position s press individua...

Страница 134: ...EC or EC will appear in each selected position These positions will appear yellow and will be automatically deselected 3 To delete position s that have been assigned select the position s and press C...

Страница 135: ...e volume clear the sample assignment from this position To do this select the sample position in the Sample Rack Layout screen and press Clear When a rack file is used it is not possible to clear a sa...

Страница 136: ...reen will appear 6 Enter a sample ID using the keyboard or enter a sample ID using the bar code scanner 7 Press OK 8 Repeat steps 1 6 for all sample IDs that need to be modified 9 To return to the ori...

Страница 137: ...an Assay Parameter Set including the number of assay standards and controls for specific assays can be defined modified using the touchscreen The parameters can also be modified using the Process Def...

Страница 138: ...individual assays can be selected manually 1 If more than one Sample slot is defined select the slot that you want the assays to be assigned to using the tabs at the top of the Selected assays list If...

Страница 139: ...he Assign each assay individually option appears Yes is selected by default This means that the selected Assay Parameter Sets have to be individually assigned to sample positions in a sample rack i e...

Страница 140: ...eue in the Assay Assignment screen to proceed with loading the QIAsymphony AS The Loading Information screen appears The Queue button is only active when each Assay Parameter Set has been assigned to...

Страница 141: ...pear in the bottom right corner of the assigned sample positions This number indicates the number of Assay Parameter Sets that have been assigned to a particular sample Important The Queue button beco...

Страница 142: ...6 Modify the desired parameters After modifying a parameter the associated value appears green A hand symbol is displayed in the active assay tab and next to the modified parameter 7 Press OK All chan...

Страница 143: ...eturn to the assay definition process 2 The Loading Information screen appears You can now load the instrument worktable Refer to Section 12 4 1 for more information 12 4 7 Validating the assay run QI...

Страница 144: ...mphony AS drawers For detailed information about the Auto Transfer tool refer to Section 8 of the QIAsymphony Management Console User Manual 12 4 8 Loading an independent run For details about how to...

Страница 145: ...riate adapter on slot 6 4 Press Load The Assay Setup Loading information screen reappears The loaded slot is now highlighted blue 5 Leave the Assays drawer open to load disposable filter tips see Load...

Страница 146: ...erformed for each drawer See Section 12 4 7 for detailed information about validating the assay run 12 4 11 Removing assays after an independent run When an assay run is completed or canceled the assa...

Страница 147: ...QIAsymphony SP AS Consolidated Operating Guide 12 2017 147 2 Press the first assay rack to be removed The detailed screen for the slot appears...

Страница 148: ...Press Remove and unload the rack The Assay Setup Loading Information screen appears again The Assay slot now appears white and slot cooling is turned off 4 Close the Assays drawer 5 Press Scan A dialo...

Страница 149: ...etailed screen for that slot appears 3 Unload the selected sample rack from the drawer and then press Remove in the touchscreen If there is a second sample rack repeat this process for the other rack...

Страница 150: ...Remove in the assay setup Overview screen Important A normalization rack containing unused positions cannot be used for subsequent runs 12 4 12 Pausing resuming and stopping an independent run 1 To p...

Страница 151: ...sible to process these samples further on the QIAsymphony AS If a run is canceled follow the procedure outlined in Section 12 3 5 to remove assays It may be possible to continue manually processing th...

Страница 152: ...es on the adapter It is therefore important that the correct plates tubes are loaded on the adapters as defined in the software 2 Tip rack slots are scanned The disposable filter tips are scanned to e...

Страница 153: ...needs to be repeated it is also possible to perform a partial inventory scan where tip racks and adapters can be scanned separately After the inventory scan has been performed the inventory of the QIA...

Страница 154: ...f the message below the error symbol see below The error message is displayed in the middle of the dialog box 13 1 1 Errors indicated in the status bar In some cases errors are indicated by the drawer...

Страница 155: ...Messages with Help button If a message appears with a Help button the user has access to instructions about how to solve the problem Proceed as follows 1 Press the Help button A new message will appea...

Страница 156: ...at is not listed contact QIAGEN Technical Services If the message does not have an error code refer to Section 13 5 for context specific errors and associated instructions Call QIAGEN Technical Servic...

Страница 157: ...Guide 12 2017 157 To return to the original screen press OK inside the help dialog 13 2 1 Structure of software help boxes A help box consists of a maximum of 3 different tabs in the following sequen...

Страница 158: ...1 Make a record of the incident 1 Note down all steps that were performed before and after the error occurred 2 Document any messages that appeared on the touchscreen Note It is important that you can...

Страница 159: ...og in to the instrument s 2 Select Instrument Report in the Tools menu The Overview tab of the Instrument Report menu appears and instrument data will be retrieved 3 To create an instrument report for...

Страница 160: ...software 31658 The Inventory Scan cannot detect an adapter bar code on eluate rack on slot X expected rack type Y A rack has been detected on slot X that does not match the rack that is defined for th...

Страница 161: ...hat there is less than 15 free disk space Result files older than 10 days default can be deleted from the instrument s Press Yes to free up file space and delete older result files Note If you choose...

Страница 162: ...atch and an elution rack ID for all samples Work lists with inconsistencies or errors Worklist_X missing required elution rack ID for samples Y multiple elution rack IDs Z A work list file defines 2 d...

Страница 163: ...en transfer the modified work list file to the QIAsymphony SP AS instruments Restart the assay definition process 75503 Your current process configuration does not allow you to clear an assignment of...

Страница 164: ...Sample volume is too small Or Not enough liquid available Slot x PosY Reagent Z This error code can occur during operation of the QIAsymphony SP and during operation of the QIAsymphony AS Samples may...

Страница 165: ...f sample to assay definitions The sample volume is insufficient for the assay s and or number of replicates Check if the sample volume corresponds to the sample volume defined in the Sample Rack Layou...

Страница 166: ...e and locked If the QIAsymphony instrument s crashed restart the instrument s and the system will unlock the locked rack files 13 5 General errors that do not have error codes Error Comments and sugge...

Страница 167: ...his is not necessarily the case For protocols and Assay Control Sets only check the validity in the QIAsymphony Management Console Delete any unsigned protocols or Assay Control Sets Do not delete oth...

Страница 168: ...e required Assay Parameter Set s are listed If the required Assay Parameter Set s are listed the work list has probably expired Assay list does not display expected Assay Parameter Set Ensure that the...

Страница 169: ...n the correct folder for the QIAsymphony SP result files or the QIAsymphony AS result files The correct folder is log Results SP or log Results AS Sample status If errors problems occur during an assa...

Страница 170: ...t type of eluate rack on the corresponding elution slot Make sure that the elution rack is correctly positioned on the elution slot Only use elution racks that are compatible with the specified adapte...

Страница 171: ...n are saved After starting and closing the Eluate Drawer dialog without changes the inventory scan of the Eluate drawer starts This is the correct behavior if you open and close the hood and press No...

Страница 172: ...ntainer in the correct orientation If the liquid waste container overflowed contact QIAGEN Technical Services Waste drawer cannot be opened The Waste drawer is locked during a run and during the inven...

Страница 173: ...ready been performed do not open the hood before starting the run If the hood was opened after performing an inventory scan the scan has to be carried out again 13 6 6 Protocol errors Error Comments a...

Страница 174: ...aintenance SP menu and select Cleanup under Cleanup Select the Crash occurred branch of the cleanup procedure See Section 2 23 1 of the QIAsymphony SP AS User Manual Operating the QIAsymphony SP Impor...

Страница 175: ...cartridge Inventory scan does not start Close the hood and all drawers and make sure to press Yes in the message that appears Check that the drawer is properly closed Make sure that the instrument is...

Страница 176: ...that all bar codes can be easily read Check that the bar code format can be read by the handheld bar code scanner See Appendix A of the QIAsymphony SP AS User Manual General Description for a list of...

Страница 177: ...ection 9 2 of the QIAsymphony SP AS User Manual General Description Filter tips are bent or deformed after liquid transfer Ensure that the correct rack type is defined on the correct slot Ensure that...

Страница 178: ...the QIAsymphony SP AS instruments for a long time after a run is complete evaporation will occur Ensure that eluate racks and assay racks are removed immediately when a run is completed Wrong volume...

Страница 179: ...d in the Integrated run Overview the Assay Setup has to be manually booked out from the system e g if sample preparation has finished and the AS batch cannot be started due to a previously stopped AS...

Страница 180: ...arting maintenance and servicing work Pay special attention to Section 2 9 14 1 Cleaning Important If liquid is spilt on the QIAsymphony SP AS worktables wipe it away as soon as the run has finished i...

Страница 181: ...cracking Clean the QIAsymphony SP AS hoods and side panels with distilled water or Mikrozid Sensitive Liquid only Europe Gigasept Instru AF Sch lke Mayr GmbH www schuelke mayr com Consists of 14 g co...

Страница 182: ...your local distributor for more information about flexible Service Support Agreements from QIAGEN Important Disconnect the line power cord from the power outlet before servicing 14 3 Regular maintena...

Страница 183: ...ing to the instructions in the handbook of the QIAsymphony Kit you are using Discard used reagent cartridges according to your local safety and environmental regulations 4 Replace the tip disposal or...

Страница 184: ...ocal safety regulations 5 Remove reagent tubes and bottles from the Eluate and Reagents drawer and discard according to your local safety regulations 6 Discard empty tip racks 7 Replace the tip dispos...

Страница 185: ...2 Tip disposal chute Important If using the QIAsymphony Cabinet SP AS refer to the instructions provided in the Maintenance section of the QIAsymphony Cabinet SP AS User Guide QIAsymphony SP 1 Remove...

Страница 186: ...rrectly positioned Take care when cleaning the Reagents and Consumables drawer 14 4 4 Drawers AS 1 Remove all removable objects tubes plates adapters from the drawers 2 Wipe the drawers and the remove...

Страница 187: ...ulations 3 Clean the liquid waste container with a glyoxal and quaternary ammonium salt based disinfectant e g Gigasept Instru AF according to the manufacturer s instructions 4 Rinse the liquid waste...

Страница 188: ...r Mikrozid Sensitive Liquid only 14 5 4 Cleaning the tube carriers SP 1 Remove tube carriers adapters and inserts and soak them in disinfectant e g Gigasept Instru AF Incubate for at least 15 min then...

Страница 189: ...drawers and soak them in disinfectant e g Gigasept Instru AF Incubate for at least 15 min 2 Rinse with water and dry with paper towels 3 Check the condition of the bar code labels and ensure that they...

Страница 190: ...IAsymphony SP AS instruments 3 Press the Start UV light button The Input UV cleanup Duration screen will open 4 Enter the duration of the decontamination in min The default setting is 15 min The UV ir...

Страница 191: ...left to run overnight 14 7 Maintenance of the tip adapter O ring This section describes replacing the tip adapter O ring using the O Ring Change Tool Set cat no 9019164 to perform O ring change The O...

Страница 192: ...II Air temperature 15 32 C 59 89 6 F Relative humidity 15 75 noncondensing Maximum 75 relative humidity for temperatures up to 31 C 88 F decreasing linearly to 50 humidity at 32 C 89 6 F Altitude Up t...

Страница 193: ...dth 128 cm 50 4 in Height 103 cm 40 6 in Depth 73 cm 28 7 in Weight 175 kg 385 8 lb QIAsymphony AS Dimensions Width 59 cm 23 2 in Height 103 cm 40 6 in Depth 73 cm 28 7 in Weight 90 kg 198 lb QIAsymph...

Страница 194: ...fic descriptions are included For detailed information about the user interface refer to the following Section 3 of the QIAsymphony SP AS User Manual Operating the QIAsymphony SP Section 3 of the QIAs...

Страница 195: ...Loading Information Enables generation of a rack ID only for assay racks AS SP Integrated Setup Sample Preparation Opens the previous screen SP Consumables Cartridges Filter Tips Displays the Keyboard...

Страница 196: ...Run Enables definition of an internal control This button is active only when internal controls are loaded in a tube carrier IR Integrated Setup Opens the Assay Assignment screen Tls File transfer In...

Страница 197: ...the Wizard This button is only visible in the Wizard when the last batch has been defined and no internal control is required AS SP IR Tls Miscellaneous Provides information to help the user complete...

Страница 198: ...and 00 00 of Monday of the current week AS Assay Setup Loading Information Displays a screen that contains information about the assigned Assay Parameter Sets in a table AS IR Assay Setup Loading Inf...

Страница 199: ...EC EC is assigned and all assigned positions have a defined volume SP General Buttons Opens the next screen in the workflow AS Assay Setup Defines a new assay run Available when no assay run is curre...

Страница 200: ...etes the current command and then pauses the assay run Samples will always be flagged as unclear if the run has been paused IR Command bar Pauses the QIAsymphony SP The Pause SP button should only be...

Страница 201: ...ng rack files saved on the QIAsymphony SP AS instrument AS SP Assay Setup Sample Preparation Displays the available rack files in the control panel Tls File Transfer In Output Files Enables upload dow...

Страница 202: ...s Tls File Transfer Instr Setup Files Enables upload download of operator service scripts for the QIAsymphony AS Tls File Transfer Instr Setup Files Enables upload download of operator service scripts...

Страница 203: ...the inventory scan of the Eluate drawer that is in progress and then opens the previous screen Tls Rack browser Sample Racks Rack browser Eluate Racks Rack browser Assay Rack Displays the rack files t...

Страница 204: ...elected position s on the rack grid SP Sample Preparation Starts the Wizard Tls File Transfer In Output Files Enables upload of work list s AS Assay Setup Switches to the work list mode If at least on...

Страница 205: ...ormity QIAsymphony SP Name and address of the company QIAGEN GmbH QIAGEN Strasse 1 40724 Hilden Germany Declaration of conformity QIAsymphony AS Name and address of the company QIAGEN GmbH QIAGEN Stra...

Страница 206: ...t at the time of disposal helps to conserve natural resources and ensures that the product is recycled in a manner that protects human health and the environment Recycling can be provided by QIAGEN up...

Страница 207: ...d and found to comply with the limits for a Class A digital device pursuant to part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference when the...

Страница 208: ...y for the duration of the original warranty period and in no case beyond the original expiration date of original warranty unless authorized in writing by an officer of the Company Read out devices in...

Страница 209: ...exception http www gnu org licenses old licenses gpl 2 0 faq html FontException As a special exception if you create a document which uses this font and embed this font or unaltered portions of this f...

Страница 210: ...QIAsymphony SP AS Consolidated Operating Guide 12 2017 210 Document revision history R2 December 2017 Updates related to standard 61010 were incorporated into the user manual...

Страница 211: ...dent run 128 Installation site requirements 24 Instrument report file 159 Integrated operation 101 Integrated run 103 loading 113 pausing resuming and stopping 126 starting 124 Intended use 11 users 1...

Страница 212: ...tegrated run 124 Startup 26 Storage conditions 192 Switching off 28 Symbols safety 22 software 40 Tab menus 39 Technical assistance 10 Tip disposal bag 57 Training 12 Transportation conditions 192 Tro...

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Страница 214: ...QIAsymphony SP AS Consolidated Operating Guide 12 2017 214 This page intentionally left blank...

Страница 215: ...itusPlus Applichem GmbH Excel Microsoft Windows Microsoft Corporation Gigasept Mikrozid Sch lke Mayr GmbH Incidin Ecolab Inc LightCycler Roche Group Sarstedt Sarstedt AG and Co Registered names tradem...

Страница 216: ...QIAsymphony SP AS Consolidated Operating Guide 12 2017 216 www qiagen com...

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