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Appendix A Specifications

Agility System

Operator’s Manual

147

A.7 Regulatory Compliance

Electromagnetic Perturbation

EMC Directive 2004/108/EC

EN 61326-2-6:2006

EN 61326-1:2006

Electrical Safety

BS EN 61010-1:2001

IEC 61010-1:2001

IEC 61010-2-101

Lead-free

All components are RoHS compliant

IVDD

CE marked per IVD 98/79/EC Directive

A.8

System Dimensions

Width

<1250 mm (49

”)

Depth

<900 mm (35

”)

Height

<1230

mm (48”)

Footprint

<1200 x 650 mm (47” x 27”)

Bench Weight

213 kg (469 lb) max.

Ship Weight

296 kg (650 lb) max

Noise

Noise Output <80 dB

A.9

Power Requirements

Voltage

100-240V automatic switching

Frequency

50/60 Hz

Power Consumption

400 VA (online UPS required)

Содержание Agility Automated ELISA System

Страница 1: ...Agility Automated ELISA System Operator s Manual Part Number 91001040 IMPORTANT Please read carefully before using the System ...

Страница 2: ...bes DYNEX reserves the right to make technical improvements to the system and documentation without prior notice as part of a continuous program of product development The information in this manual is of a proprietary nature No part of this publication may be reproduced stored in a retrieval system translated transcribed or transmitted in any form or by any means without prior written permission ...

Страница 3: ... Detection 29 3 4 3 Liquid Level Detection 29 3 5 Reagent Pipettor Arm 30 3 5 1 Overview 30 3 5 2 Reagent Dilution 32 3 5 3 Reagent Mixing 32 3 6 Sample Loading Module 33 3 7 Consumable Drawers 34 3 8 Microplate Washer 35 3 9 Microplate Reader 39 3 10 Temperature Incubators 40 3 10 1 Ambient Incubators 40 3 10 2 Elevated Temperature Incubators 40 3 11 Front Doors 41 Chapter 4 Operating the Agility...

Страница 4: ... 92 5 4 1 Removal of the Fluidics Panel Assembly 93 5 5 Replacing Tubing on the Fluidics Panel 95 Chapter 6 The Graphical User Interface 97 6 1 Introduction 97 6 2 The Administrator Screen 97 6 3 The Home Screen 99 6 4 The Dashboard 103 6 5 Worklist 106 6 6 The Timeline 108 6 6 1 Overview of the Timeline 108 6 6 2 Icons on the Timeline Screen 110 6 6 2 1 Samples Rack Status Screen 111 6 6 2 2 Smar...

Страница 5: ...gent Pipetting Specifications 145 A 4 Reader Specifications 146 A 5 Washer Specifications 146 A 6 Incubator Specifications 146 A 7 Regulatory Compliance 147 A 8 System Dimensions 147 A 9 Power Requirements 147 Appendix B Consumables and Spare Parts 149 Limited Warranty 151 Warranty and Special Provisions 151 Index 153 DYNEX Technologies Contact Information 155 ...

Страница 6: ...Table of Contents 6 Agility System Operator s Manual This page intentionally left blank ...

Страница 7: ...ional point of view Analyzing Samples Chapter 4 discusses the steps involved in loading samples reagents and consumables generating a worklist and obtaining analytical results Maintenance and Troubleshooting Chapter 5 includes a list of activities that should be performed on a periodic basic to ensure optimum operation and explains what to do when there is a problem Details of the User Interaction...

Страница 8: ...About this Manual 8 Agility System Operator s Manual This page intentionally left blank ...

Страница 9: ...terface is used to indicate the desired operation of the system to analyze the samples If desired multiple assays can be performed on a given sample Figure 1 1 The Agility Automated ELISA Processing System In normal operation all materials are inserted into the system and waste is removed via the ports shown in Figure 1 1 The status of each port is indicated by a multi colored LED see Section 4 fo...

Страница 10: ...assay kits and is simply placed into the Agility Automated ELISA Processing System As an alternative a generic pack design can be used to hold standard fluid containers that the laboratory user fills from the bottles of a manufacturers test kit The pack is fitted into a reagent pack holder to be loaded on the system through the reagent pack load position A typical SmartKit and reagent pack holder ...

Страница 11: ...Diameter 10 17mm Internal Diameter 8 14mm Height 40 100mm The system is capable of reading standard laboratory sample barcode labels and identifying the position of each tube Figure 1 3 Sample Loader 1 4 Microplates A microplate is inserted into a microplate holder Figure 1 4 that is used to hold and aid transportation of the microplate around the system The microplate holder is marked with white ...

Страница 12: ...tion is stored in the event log for tracking and usage reference The sample tip rack is loaded on to a consumable drawer and may be loaded in either orientation that fits into any of the four locations on a drawer Figure 1 5 Sample Tip Rack b Reagent Tip Rack Reagent tips are supplied in a reagent tip rack which holds 98 tips and are loaded into a reagent pack holder Figure 1 6 for use on the syst...

Страница 13: ...amples The deep well strip holder is loaded on to a consumable drawer and may be loaded in either orientation that fits into any of the four locations on a drawer The deep well strip holder is refillable with deep well strips and has a two dimensional barcode located on one side of the narrow end of the holder for the camera on the transport arm to identify the consumable as a deep well strip hold...

Страница 14: ...prior to dispense due to time stability of the mixed components The reagent mixing well holder is filled with 18 reagent mixing wells and loaded on to a consumable drawer It may be loaded in either orientation that fits into any of the four locations on a drawer The reagent mixing well holder is refillable with reagent mixing wells and has a two dimensional barcode located on each narrow end of th...

Страница 15: ...te reservoir was emptied and counter reset 1 7 Setting up for LIS Link LIS Link is a separate application that may be installed to enable bidirectional communication with the laboratory s LIS system Worklists may be set up automatically according to downloaded information from the LIS system And results of processing and analysis can be sent automatically or through operator efforts to the LIS sys...

Страница 16: ...Power receptacle area Three more are located in the power switch area in the front on the lower left Figure 1 11 Power switch area Setup of the port Each port is automatically assigned a name by Windows However LIS Link software only recognizes port names COM1 to COM9 ...

Страница 17: ...ck on Computer to bring up Device Manager Figure 1 12 Computer configuration Figure 1 13 Device Manager Select the Prolific USB to Serial Comm Port If is not named COM1 to COM9 it must be renamed COM8 and COM9 are available for LIS Link and LIMS HOST Renaming a COM port Right click on Properties ...

Страница 18: ...Chapter 1 Overview 18 Agility System Operator s Manual Figure 1 14 COM Port Selection Figure 1 15 COM Port Properties ...

Страница 19: ...proper COM name from COM Port Number list All USB hubs must have power management turned off In Device Manager select Universal Serial Bus Controllers Figure 1 17 Right click and select Properties on every Generic USB Hub and every USB Root Hub For each got to the Power Management tab Figure 1 18 and unselect Allow the Computer to Turn off this device to save power ...

Страница 20: ...Chapter 1 Overview 20 Agility System Operator s Manual Figure 1 17 USB Hub Setup Figure 1 18 USB Hub Setup ...

Страница 21: ...is described below Potential personal injury to the operator or damage the system can result if the labels are not followed Label Description Alternating current is present Caution symbol Refer to the Routine Maintenance chapter Caution motion hazard Caution pinching or mechanical hazard Caution hot surface Laser radiation Do not stare into beam Protective conductor terminal Earth ground terminal ...

Страница 22: ...al to successful sample tube barcode scanning Scanning is in accordance with ASTM E1466 92 defining barcode quality position and orientation of barcode labels The use of non standard barcodes or barcodes with poor print quality may be problematic Barcode labels should be applied using a vertical orientation The barcode label should be oriented so that it faces out of the opening in the sample rack...

Страница 23: ...ed for use to clean and disinfect Agility Please contact your instrument provider if there is any doubt about the compatibility of decontamination or cleaning agents with Agility 17 Agility is tested and compliant to IEC 61326 1 2006 standard for Electrical equipment for measurement Control and laboratory use with particular requirements for in vitro diagnostic devices 18 All parts and accessories...

Страница 24: ...Chapter 2 Safety 24 Agility System Operator s Manual This page intentionally left blank ...

Страница 25: ... workplace In addition a number of other devices such as pipettors to transfer liquids cameras to read the two dimensional labels incubators and an absorbance reader are included in the system 3 2 Workspaces 3 2 1 Lower Workspace The lower workspace area Figure 3 1 provides the locations for SmartKitsTM microplates sample tips deep well strips reagent packs and samples It can contain three SmartKi...

Страница 26: ...Upper Reagent Workspace The Upper reagent workspace Figure 3 2 has four locations capable of holding reagent packs or reagent tips and two locations capable of holding microplate holders deep well strip holders or mixing well holders Figure 3 2 Upper Reagent Workspace ...

Страница 27: ...he operations defined by the controlling software and the worklist The transport arm has gripper arms for positive locking and moving the consumable holders around the system In addition the gripper arms are also used to operate sliding doors and lock mechanisms within the system Figure 3 3 Transport Arm There is a camera associated with the transport arm which is used for reading two dimensional ...

Страница 28: ...lution fluid from the dilution strips to microplate wells Transfers controls or standard fluids from reagent packs to microplate wells or dilution strips Mixes fluid within a dilution strip Figure 3 4 Sample Pipettor The sample pipettor is capable of dispensing between 10 µL and 300 µL in single shot mode with an accuracy of 2 of target volume in its operating range single shot based on using a ne...

Страница 29: ...tor must prevent the spigot from coming in contact with the fluid Before tip eject to check the tip has not fallen off between aspirating the sample and after dispense After tip eject to ensure the tip was ejected Note For every single shot transfer of sample fluid a new tip is used 3 4 3 Liquid Level Detection The sample pipettor is capable of determining a liquid level The tip submersion into th...

Страница 30: ...the reagent tip rack Transfer reagent fluid from a reagent bottle in a reagent pack to a microplate well Transfer reagent fluid from a reagent bottle in a reagent pack to a deep well dilution strip well Transfer reagent fluid from a reagent bottle in a reagent pack to a mixing well Mix reagent fluids through aspirating dispensing in a mixing well Transfer fluid from a mixing well to a microplate w...

Страница 31: ...ed on using a new tip 5 of target volume in operating range multi shot based on using a new tip 5 of target volume in operating range single shot based on reusing a tip Note Accuracy specification based on using de ionized water The Reagent Pipetting Precision is 3 CV at 10 shots at any volume in operating range single shot with a new tip 5 CV at 10 shots at any volume in operating range multi sho...

Страница 32: ...iluent then these should be the volumes that are used to make the dilution even if there is more diluted fluid in the deep well than required However the volumes will scale up to make more fluid available to be pipetted to the microplate if the set volumes are not be sufficient to meet all the microplate dilution requirements When performing a deep well dilution the system dispenses all the diluti...

Страница 33: ...at a time The system includes10 sample tube racks which each hold 20 sample tubes Each rack is capable of holding sample tubes with physical dimensions of External Diameter 10 17 mm Internal Diameter 8 14 mm Height 40 100 mm The system can detect the presence of a sample tube to determine if a tube has been loaded in a sample rack tube position It can determine the height of each loaded sample tub...

Страница 34: ...e custody of the contents of the drawer for usage tracking of consumables and instrument status Once all consumable items on a drawer have been used the drawer is unlocked and the status light changed to a pulsing blue so that the user may reload further drawer items To aid the user as to what to load when additional consumables are required the system will schedule a load wizard window for the op...

Страница 35: ... Wash Head floats mechanically minimum of 3 mm to allow for any inaccuracy of matching the wash head to the plate Figure 3 7 Microplate Washer Module The wash head pin heights are configurable to allow specific wash head heights to be used and adjusted when a specific plate type definition is selected for an assay Wash head heights are configurable for Dispense Height Top of well height Aspirate H...

Страница 36: ...re moving on to strip 3 until the required number of strips is completed Four different wash operations can be programmed a Standard Wash If a Standard Wash operation is programmed the wash head will initially aspirate the well prior to dispensing the programmed dispense volume to the well from the dispense height set in the plate definition usually above the well b Bottom Wash If a Bottom Wash op...

Страница 37: ...sh soak time time fluid is left in the well before being aspirated a Soak at end of cycle A soak period is specified to be performed at the end of each programmed wash cycle b Synchronized Soak A synchronized soak is specified This soak functions in Strip Wise wash mode and calculates a soak delay for washing each strip from the time it takes to perform the pipette to plate operation on each strip...

Страница 38: ...aintains a constant cycle soak time regardless of the actual number of test strips run and is designed to improve reproducibility c Auto Wash The washer has an Auto Wash feature that automatically flushes clean fluid at a user set volume after each wash program is completed This is designed to flush the wash head at completion of the wash operation with distilled water to prevent the wash head bec...

Страница 39: ...t filter wavelength and the readings are reported as the optical density OD b Dual Wavelength Mode This mode reads the plate twice using two different specified filters test reference The values read using the specified reference filter are subtracted from the readings obtained from reading with the test wavelength and the net value is reported as the optical density c Blank Mode The reader can bl...

Страница 40: ...esigned to be no greater than the laboratory ambient temperature 3 C The user can program the length of time for an incubation operation The ambient incubators are capable of shaking at three speeds low medium high The incubators shake for the duration of the incubation period or a set initial period The ambient temperature in the well during the shake will remain below ambient 3 C Special custom ...

Страница 41: ...Doors The two main front doors are locked electronically by the instrument when the instrument is powered up and in use In the event of a power failure the doors are also locked The doors can be opened using a manual key in the event of a power failure On start up following a power failure a user request will be required to determine if the user has opened the doors manually If the doors have not ...

Страница 42: ...Chapter 3 System Design 42 Agility System Operator s Manual This page intentionally left blank ...

Страница 43: ...em A worklist can be created manually as described in Section 4 5 1 or via a Laboratory Information System LIS The analysis of samples will begin when all required materials and information for an assay on the worklist has been loaded onto the system and the Start button is pressed on the Worklist Filter screen The order of the various operations for the assay is determined by the specific require...

Страница 44: ...a front loading bay The transport arm camera will scan the barcode to determine how many reagent tips are available and will move the rack to one of the internal upper reagent pack holding positions 6 Load the SmartKits needed for the worklist into the front loading bays The transport arm camera will scan each position to determine which assays are available and how many samples may be run against...

Страница 45: ...lly present the user with the screen shown in Figure 4 1 Figure 4 1 The Start Screen There are three large buttons Agility This button enters the standard mode of operation and presents the Home screen Figure 4 2 CTV This button activates routines for control test and verification It is used for service and maintenance It should only be used by trained service technicians Explorer This button lets...

Страница 46: ...f Test Procedure When the Home screen Figure 4 2 is presented a number of self tests will be automatically performed The results of the self tests will be presented on the screen along with additional support information During the self tests the screen will include the message Initializing Figure 4 2 The Home Screen ...

Страница 47: ...th filters installed on the six position filter wheel for use with the absorbance OD reader However there may be a need to reconfigure the system with new filters if different wavelengths are required for certain assays If any filters are changed on the filter wheel they must be defined and stored in the instrument database such that the operation can move to the filter designated by the assay On ...

Страница 48: ... highest OD reading permitted as valid for reporting is designated as Over Range This has not yet been implemented in Agility version 1 0 4 4 5 System Dashboard To access the user interface press the Dashboard button to present the Dashboard which is a snapshot of the system status Figure 4 4 Figure 4 4 The Dashboard Screen ...

Страница 49: ...ntainer is empty and there is sufficient Washer Fluid to perform the desired assays To disconnect a fluid line press the metal spring on the spigot Figure 4 5 Waste Fluid and Washer Fluid Containers All waste fluids should be discarded in a manner that meets the safety and environmental requirements of your facility Warning Chemical and Biological Hazards The wash solution and waste may contain co...

Страница 50: ...ould be primed and conditioned to ensure proper volume delivery The start of day aspirate and dispense assays must be imported onto the Agility using the Transfer from USB device to system feature These assays automatically install in the C Assays directory when Agility version 1 05 or higher is installed however they must be imported onto the system before use After transferring the assays onto t...

Страница 51: ...h 12 strips When performing the Dispense Assay the plate will be left full of fluid Operators should verify wells are filled evenly Dynex recommends repeating the Dispense Assay for all wash bottle positions that will be used during the course of the worklist to verify bottle and tubing functionality After performing the Dispense Assay s perform the Aspirate Assay When prompted for the plate inser...

Страница 52: ...Chapter 4 Operating the Agility System 52 Agility System Operator s Manual Figure 4 9 Wash Assay Screen ...

Страница 53: ...System Agility System Operator s Manual 53 Empty the Used Tip Container The Used Tip container is located behind the right lower panel Figure 4 10 The operator should ensure that the container is empty Figure 4 10 Tip Waste Container ...

Страница 54: ...each session It should be noted that the status of consumables and SmartKits is monitored by the system and messages will be provided when additional items need to be loaded to meet the workload requirements 4 7 1 Loading Samples The Agility system can hold 200 Sample Tubes 10 racks of 20 Tubes and can detect the tube Position Sample ID Barcode and the Sample Tube size detection Height x Diameter ...

Страница 55: ...racters are correct for the barcode symbology that is being used Use the correct number of data digits for a specific barcode symbology 10 The following symbologies are supported by Agility Codabar Code 39 Code 93 Code 128 Standard 2 of 5 Interleaved 2 of 5 MSI Plessey and UPC EAN JAN Symbologies with poor internal verification or partial decodes such as Interleaved 2 of 5 Standard 2 of 5 and MSI ...

Страница 56: ...le depressing the handle button move the Sample Loading Handle Figure 4 12 to a slot with a white indicator light and slide the rack slowly and steadily into the rack guide until the rack locks in place Moving the racks too quickly into place may result in erroneous barcode interpretation Figure 4 12 Sample Loading Handle ...

Страница 57: ...rack detection error or the sample barcode was not successfully read A sample alert will be displayed on the screen to alert the operator to reload or retry the scanning of the rack Blue Light The samples are being analyzed The sample rack light will change from green to blue when at least one sample on the rack has been included in a running worklist Sample racks must not be removed while the lig...

Страница 58: ...l appear in the top right position which when pressed will access the sample rack status screen The tabs at the bottom are shown here in green which indicates all tubes in these rack positions have tubes that have had the sample ID read or manually entered and are ready for testing The tabs will be blue if the samples have been aspirated for an assay The sample ID information is still available at...

Страница 59: ... in Figure 4 14 If desired the Tube Type and Tube Description fields can be edited via the drop down menu The last column in the Sample Load screen indicates the assay to be performed on the sample this is provided through worklist assignment or through the LIS Link interface with the laboratory s LIS system If desired sample information can be edited by pressing a sample ID box to present a keybo...

Страница 60: ...ting the Agility System 60 Agility System Operator s Manual Figure 4 15 Sample Rack Status Editing If a sample ID has been entered manually it will be shown with a hatched pattern radio button as shown in Figure 4 16 ...

Страница 61: ...Chapter 4 Operating the Agility System Agility System Operator s Manual 61 Figure 4 16 Sample Rack Status Screen with manually entered sample ID ...

Страница 62: ...the same manner and the sample loading handle should be moved to the new rack position so that the samples are read Note Samples can be added while other operations are being performed by withdrawing any rack that is in a slot indicated by a white light and repeating the above operations 7 After all samples have been loaded press the button Figure 4 16 to accept the scan s ...

Страница 63: ...drawer 1 in positions 1 and 2 That is they may be inserted such that the system scans this drawer for the consumables before a worklist is submitted for scheduling The lights adjacent to each tray signify the following White Light Drawer position is empty a drawer with new items may be loaded in that position Orange Light Drawer has been recognised as loaded by the system but pending an item scan ...

Страница 64: ...een read When the barcodes have been read the indicator light will turn blue and the consumables inventory in the system computer will be updated The system may not read the consumables inventory right away as it may be busy with other activities Note Consumables can be added while other operations are being performed by withdrawing any rack that is in a slot indicated by a pulsing blue LED indica...

Страница 65: ...as the position is empty Orange Light SmartKit Detected A SmartKit has been loaded awaiting barcode read to determine SmartKit Item Red light Error on SmartKit Load Barcode not read or no matching Assay loaded Blue Light SmartKit Position busy either the SmartKit has been recognised and is in use or empty position is busy awaiting SmartKit placement by instrument It may also have been designated t...

Страница 66: ...s press the rack information area of the Dashboard Figure 4 20 Figure 4 20 Rack Information Area of the Dashboard 4 7 4 Load Reagent Tip Racks Place the fully loaded Reagent Tip Rack in any pack door rack loading bay position with a white indicator light The pack should be loaded so that the large label faces inside the system When the reagent pack is detected the indicator light will change to or...

Страница 67: ...or and the light will change to blue 4 8 Performing an Assay If the SmartKits consumables and other materials required for the assay s are present in the system the Timeline screen Figure 4 21 will be presented and assays will be initiated Figure 4 21 A Timeline If an item required for the assay is not present in the system the timeline may not be initiated and an icon corresponding to the missing...

Страница 68: ...ished the system will indicate that a microplate that matches a SmartKit assay is required via a white light indicator surrounding the microplate loading bay In addition the icon will be placed at the top of the screen Selecting this alert icon shows the plate to be loaded according to the worklist Figure 4 22 Plate Status A plate nickname can be entered on this screen to aid the user in identifyi...

Страница 69: ...example shown above the assay definition has indicated position A1 is a blank gray B1 a negative control green C1 through E1 are standards blue G1 is a positive control red and the rest are test samples white To obtain an overall view of the status of the system press the Dashboard button A typical Dashboard presentation is presented in Figure 4 24 This screen will provide information about the pr...

Страница 70: ...igure 4 24 A Typical Dashboard during System Operation To determine the detailed status of various consumables press the appropriate area on the right side of the Dashboard screen 1 Plates Region top fields Presents Figure 4 25 which provides information about the active plate ...

Страница 71: ...Chapter 4 Operating the Agility System Agility System Operator s Manual 71 Figure 4 25 Plate Information 2 Reagents Region Second Region Presents Figure 4 26 describing the status of the reagents ...

Страница 72: ...Chapter 4 Operating the Agility System 72 Agility System Operator s Manual Figure 4 26 Reagents Status 3 Fluids Status Third Region Presents information about the buffers and wash fluids Figure 4 27 ...

Страница 73: ...way from this screen and then return to see the new fluid levels The amount of fluid available for a worklist is assigned at the start of the worklist If an operator removes the bottle and fills it with more fluid the instrument is not aware of the new fluid levels for that worklist that has already started Starting a new worklist via continuous loading the operator must once again input the fluid...

Страница 74: ...Chapter 4 Operating the Agility System 74 Agility System Operator s Manual Figure 4 28 Consumables Status ...

Страница 75: ...ator s Manual 75 4 9 Viewing Data To generate a search for data 1 Press the button to present the Search screen Figure 4 29 Figure 4 29 Search Screen 2 Enter the desired parameter to define the data to be viewed A typical results screen is shown in Figure 4 30 ...

Страница 76: ...ity System 76 Agility System Operator s Manual Figure 4 30 Typical Results Screen The results can be viewed in a variety of formats by selecting the appropriate button on the left side of the results screen as shown in Figure 4 31 ...

Страница 77: ...Chapter 4 Operating the Agility System Agility System Operator s Manual 77 Figure 4 31 Data Format Options The various formats are described in Chapter 6 ...

Страница 78: ...iled or all plates depending on the user selection All unused plates and SmartKits used for to those plates will be returned to the loading bays The system may not stop immediately Some actions being performed at the time may need to arrive at a state where the system can be safely stopped before discontinuation The plate may continue through the operation sequence but no further samples will have...

Страница 79: ...ks open the left and right doors respectively When the doors have been opened this screen must remain active The doors must be closed and locked before proceeding once again by exiting this screen by selecting the green arrow button To Pause the System 1 Press the Pause button on the touchscreen 2 To unlock a door select the lock for the door to be opened The green arrow button will disappear and ...

Страница 80: ...n button to go back to the home operations screen To Abort Plates Select the icon Select the plates wished to be aborted Select Abort Plates button Figure 4 34 Abort Plates Screen 4 10 2 System Shutdown 1 At the end of a session or any other time the system should be shut down after worklist operation press the Instrument Stop button ...

Страница 81: ...nd plates The indicator lights will change to white 3 Select Shutdown on the screen The consumables will be returned to the to the consumables drawers the drawers will be unlocked and the indicator light will change to pulsing blue 4 The screen will show the 3 button launch screen and then power off ...

Страница 82: ...Chapter 4 Operating the Agility System 82 Agility System Operator s Manual This page intentionally left blank ...

Страница 83: ...iohazards Always wear protective gloves when handling potentially hazardous substances 2 Empty and clean the liquid waste container as needed Note If desired the waste tip container and the liquid waste container can be disinfected with 70 ethanol The containers must be thoroughly rinsed with deionized water before replacing as residual alcohol fumes may affect the results of ELISA assays 3 Clean ...

Страница 84: ...uffer bottles with distilled water d Run several wash assays using fluid from each buffer bottle until alcohol disinfectant is removed from the tubing lines Annual Maintenance Agility Preventative Maintenance One annual visit includes the following System Self Test check that all tests pass Clean all exterior surfaces Replace tubing set including filter and verify bottles Replace lamp once per yea...

Страница 85: ...must certify that the unit has been decontaminated 5 2 1 Cleaning the System The system is constructed from materials that are resistant to chemical attack Spills should be cleaned up as soon as possible and all external surfaces should be kept clean Warning Make certain that the power cable is disconnected before cleaning the instrument To Clean the System 1 Clean external surfaces waste containe...

Страница 86: ...ogies facility the customer must decontaminate the system before shipment and a decontamination certificate must be submitted with the unit To Decontaminate the System 1 Wipe the surfaces with a cloth moistened with a 70 v v solution of alcohol 2 Clean the waste containers wash containers and tubing lines with 70 alcohol Run 70 alcohol through the tubing lines Run deionized water through the tubin...

Страница 87: ...y and fit for transport Signed ____________________________________________ Title ____________________________________________ Date __________________ DYNEX Technologies reserves the right to refuse improperly cleaned equipment Shipping address DYNEX Technologies Attn Above return number 14340 Sullyfield Circle Chantilly VA 20151 1683 Suggested decontamination methods Readers Wipe all surfaces wit...

Страница 88: ... Section 1 3 2 A 405 nm filter is placed in position 1 of the filter wheel which is mounted on the lamp assembly and additional filters are fitted to meet the requirements of the facility Replacement of filters is described in Section 1 3 3 5 3 1 Accessing the Lamp and Filters The Reader Assembly is located in the Reader Enclosure and can be removed from the system by removing the two fittings as ...

Страница 89: ...g the Lamp To replace the lamp 1 Open the door to the Primary Optics Assembly 2 Slide out the Primary Optics Assembly Figure 5 3 Figure 5 3 Primary Optics Assembly 3 Remove the Reader Lamp Assembly from Lamp Bracket by unscrewing the screws that attach the assembly from the bracket Figure 5 4 ...

Страница 90: ... lamp and place a new lamp in position Note When replacing the lamp take care not to get fingerprints or other foreign material on it It is recommended that gloves are worn during this procedure If fingerprints or other foreign material gets deposited on the lamp remove it with a soft tissue saturated with methanol 6 After the cap head screws are tightened place Loctite 425 on them to secure them ...

Страница 91: ...mbly and additional filters are fitted to meet the requirements of the facility On a periodic basis it may be necessary to change a filter To replace a filter remove the existing filter and install a new filter into the desired position of the Filter Wheel Push filter past spring tines such that annular grove aligns with the filter wheel slot Figure 5 5 405 Filter Note Position 1 must contain a 40...

Страница 92: ...enance and Troubleshooting 92 Agility System Operator s Manual 5 4 Replacing Tubing The Fluidics Panel Assembly is located on the lower left of the system Figure 5 6 Figure 5 6 Location of the Fluidics Panel Assembly ...

Страница 93: ...anual 93 5 4 1 Removal of the Fluidics Panel Assembly To remove the Fluidics Panel Assembly 1 Remove the four screws attaching it to the system Figure 5 7 2 Disconnect the Vacuum Tube from the bulkhead as shown in Figure 5 8 Figure 5 7 Fluidics Panel Assembly Connections ...

Страница 94: ...Chapter 5 Maintenance and Troubleshooting 94 Agility System Operator s Manual Figure 5 8 Disconnecting the Vacuum Tubing 3 Disconnect the Pinch Valve tubing from the T connectors ...

Страница 95: ...ld be replaced as necessary It is recommended that the tubing be replaced when cloudiness or cracking is observed The dispense valve tubing is depicted in Figure 5 9 The 45 mm tube end should be connected to the KNF pump outlet Figure 5 9 Dispense Valve Tubing The tubing from the KNF pump should be connected to the wash head manifold as shown in Figure 5 10 ...

Страница 96: ...nance and Troubleshooting 96 Agility System Operator s Manual Figure 5 10 Connecting the KNF Pump to the Wash Head Manifold After the tubing has been replaces connect the vacuum tubing and reinstall the entire assembly ...

Страница 97: ...ht corner of the instrument A number of USB ports and Ethernet ports are provided to input assay files and related information and to output data When the system is powered up Administrator screen Figure 6 1 will ultimately be All instrument lights will illuminate for a short period of time during the initial power up procedure 6 2 The Administrator Screen The Administrator screen Figure 6 2 provi...

Страница 98: ...Chapter 6 The Graphical User Interface 98 Agility System Operator s Manual Figure 6 1 The Administrator Screen ...

Страница 99: ...screen is selected the Home screen Figure 6 2 will be presented Figure 6 2 The Home Screen When the Initialize All Modules button is selected the self test the homing procedure and the recognition of the status of all modules and consumables will be performed The results are shown at completion of the process Figure 6 3 and the instrument is then ready for operation ...

Страница 100: ...6 The Graphical User Interface 100 Agility System Operator s Manual Figure 6 3 The Startup Status Report Screen The hardware module versions can be viewed by pressing the arrow icon on the top right Figure 6 4 ...

Страница 101: ...Chapter 6 The Graphical User Interface Agility System Operator s Manual 101 Figure 6 4 The Version Report Screen ...

Страница 102: ...sent information about the system status The Instrument Dashboard is described in Section 6 4 SmartKit Tools accesses a screen that allows the user to open programs that relate to the use and maintenance of SmartKits File Management accesses a screen for File Management e g entering a new assay LIS Link Reset resets LIS Link transmission parameters The buttons on the bottom of the Welcome screen a...

Страница 103: ...ashboard is used to present a summary of the present status of the system and present operation When the system is initiated the Upcoming Tasks In Progress Scheduled Plates and Completed Plates fields will be empty A typical screen during operation is presented in Figure 6 5 Figure 6 5 The Dashboard Screen The Upcoming Tasks field indicates operations that the system will perform in the near futur...

Страница 104: ... Agility System Operator s Manual The In Progress field indicates the most current five actions and the time for which they were performed or will be performed The Completed field tells how many tests have been completed in the day s operation ...

Страница 105: ...us components e g the temperature of the incubators Log Viewer Section 6 8 accesses a series of screens that are used to view data system events and related issues Reagent Packs Section 6 9 accesses a series of screens that describe the various reagent packs that are loaded Results Section 6 9 accesses a series of screens that present analytical results Home returns the Home screen Figure 6 2 The ...

Страница 106: ... A typical worklist is presented in Figure 6 8 When additional information becomes available through the loading of SmartKits Reagent tip packs or the LIS Link interface the screen will be populated with what is known Figure 6 6 The Worklist When the sample racks loaded with sample tubes are inserted the laser scanner will automatically recognize the size of the tubes and their locations and reads...

Страница 107: ... status of each sample If the Agility is interfaced to an LIS system the assays to be performed on each sample will be automatically indicated in the column otherwise the operator must check the samples to be run with each test in figure 6 6 all samples are to be assayed via PLAC When all of the information needed for processing is available and all samples are successfully loaded the Next Worklis...

Страница 108: ...e area on that timeline for which greater detail is desired The timeline for plate processing is accompanied by its corresponding plate description to the left in a corresponding table If there are more than six plates running the table can be adjusted via the arrows on the left showing the plates running in order to scroll through all plates Alternatively the arrow pointing downwards on the right...

Страница 109: ...e left side of the screen are used to determine the status of various aspects of the system Section 6 4 3 The button accesses the User Timeline screen Figure 6 9 Figure 6 9 The User Timeline Screen The upper half of the user timeline Figure 6 10 provides a rapid way of determining when plates fluids SmartKits and various consumables may need to be replaced and when the waste fluid must be drained ...

Страница 110: ... The icons on the left side of the time line access additional screens which provide details about various aspects of the system Timeline Section 6 5 Samples Section 6 5 2 1 SmartKits Section 6 5 2 2 Plates Section 6 5 2 3 Consumables Section 6 5 2 4 Incubators Section 6 5 2 5 Buffers and Waste Section 6 5 2 6 ...

Страница 111: ...anual 111 6 6 2 1 Samples Rack Status Screen The Samples Rack Status Screen Figure 6 10 indicates that status of each sample in each rack The various racks can be accessed by pressing the rhomboid tabs at the bottom of the screen Figure 6 10 Sample Rack Status Screen ...

Страница 112: ...een The SmartKit screen Figure 6 11 lists the reagent packs that are resident in the system along with the type of liquids volume of each liquid Kit Lot and expiration date for each kit To select the kit to be viewed press the appropriate item in the listing Figure 6 11 SmartKit Information Screen ...

Страница 113: ...E1 are standards blue F1 is a positive control red and the rest are test samples white Figure 6 12 Plate Status Screen Each plate in the system can be accessed via a drop down menu adjacent to the Plate ID information If there are many plates some plates may be beyond view More plates may be seen by clicking on the arrow scroll button Plate Maps can be printed from the Plate Status Screen by selec...

Страница 114: ...Status screen Figure 6 13 provides information about the contents of the five drawers on the right side of the system The lock sign indicates that the drawer is locked and in use for current assays while the unlocked icon indicates that the drawer is not locked and could be restocked by the user Figure 6 13 Consumables Screen ...

Страница 115: ... Incubator Screen The Incubator Status screen Figure 6 14 presents the present temperature of each of the incubators Figure 6 14 Incubator Status Screen As shown here there will be an indicator when the temperature does not fall within instrument specifications and may need servicing ...

Страница 116: ...ace 116 Agility System Operator s Manual 6 6 2 6 Wash Bottle Status Screen The Wash Bottle Status screen Figure 6 15 presents the level of each of the washer fluid containers and the waste fluid container Figure 6 15 Washer Status Screen ...

Страница 117: ...meline for plate processing is accompanied by its corresponding plate description to the left in a corresponding table If there are more than six plates running the table can be adjusted via the arrows to scroll through all plates Operation details can be shown by pressing on any operation bar item in the zoomed view On the upper timeline display there is a Now Clock When the arrows to the side of...

Страница 118: ...resent status of the system as described in Section 6 4 The Log Viewer Screen The Log Viewer screen Figure 6 17 presents the ability to query and view the listing of events that have been recorded while the system is running The operator can define the search via the Date Selection parameter or the Category event type parameter using the drop down menus Figure 6 17 Log Viewer Screen ...

Страница 119: ... 6 9 Results The Results screen is used to present the results of the assays The data can be presented in a number of formats as described in this section When the Results icon is selected the Results Data Base Search screen Figure 6 18 is presented Figure 6 18 Results Screen ...

Страница 120: ... the desired search parameters have been selected and the Display Results button is pressed the Results Summary table is presented Figure 6 19 Note The format of the Results Summary table is dependent on the Search Parameters that have been selected Figure 6 19 Results Summary Table ...

Страница 121: ...e left side of Figure 6 22 access a broad variety of data formats as described below Result Lot Info Section 6 9 1 OD Results Table Section 6 9 2 Threshold Table Section 6 9 3 Ratio Table Section 6 9 4 Curve Fit Table Section 6 9 5 Curve Fit Graph Section 6 9 6 Spreadsheet Table Section 6 9 7 ...

Страница 122: ...er Interface 122 Agility System Operator s Manual 6 9 1 Result Lot Table The Result Lot table Figure 6 20 presents information about the assay conditions used to generate the data and is not editable Figure 6 20 Assay Lot Editor ...

Страница 123: ...or s Manual 123 6 9 2 OD Results Table The OD Results table Figure 6 21 presents the raw data statistical information and the results of the assay It also indicates if the raw data meets the quality control requirements of the assay Figure 6 21 OD Results Table ...

Страница 124: ... 9 3 Threshold Table The Threshold table Figure 6 22 presents the raw data statistical information and the results of the assay It also indicates if the raw data meets the pass fail requirements of the assay using the equation s in the assay protocol Figure 6 22 Threshold Table ...

Страница 125: ...25 6 9 4 Ratio Table The Ratio table Figure 6 23 presents the raw data statistical information and the results of the assay It also indicates if the raw data meets the Ratio equation requirements of the assay using the equation s in the assay protocol Figure 6 23 Ratio Table ...

Страница 126: ...Graphical User Interface 126 Agility System Operator s Manual 6 9 5 Curve Fit Table The Curve Fit table Figure 6 24 presents the data used to generate calibration curve used for the assay Figure 6 24 Curve Fit Table ...

Страница 127: ...e outliers choose the outlier to be removed by unselecting the checkbox associated with that standard Once the standard checkbox is unselected the standard curve will be redrawn without the standard included To generate a new report press the Reprocess button in the lower right corner of the screen circled red in Figure 6 26 A plate ID for the new data will be the original plate ID appended with a...

Страница 128: ...Chapter 6 The Graphical User Interface 128 Agility System Operator s Manual Figure 6 26 Outlier Removal 6 9 7 Spreadsheet This view presents spreadsheet function table information ...

Страница 129: ...anual 129 Figure 6 27 Spreadsheet View 6 10 Pause Stop Abort Note A detailed discussion of the Stop operations can be found in Section 4 3 The sequence to Pause Abort Plates or Stop the System is initiated by the button which presents the Stop Abort screen Figure 6 28 ...

Страница 130: ...s failed or all plates depending on the user selection All unused plates and SmartKits used for to those plates will be returned to the loading bays The system may not stop immediately Some actions being performed at the time may need to arrive at a state where the system can be safely stopped before discontinuation Plate maps will be automatically exported for aborted plates Files will be located...

Страница 131: ...t plate maps in xml format for all plates scheduled on the system Files will be located in C Program Data Dynex Technologies Plate 6 11 Utilities Screens Various utilities may be accessed from the Home screen Figure 6 29 Home Screen SmartKit Utilities This button accesses a means to assign information to a SmartKit ...

Страница 132: ...h will contain descriptive information about reagent lot including such things as expiry date individual correction factors and standard values Other SmartKits will not have this larger barcode label or the two smaller labels Information can be entered at this screen Once entered it must be stored to the database by clicking on the disk icon at the top By clicking on the printer icon labels for th...

Страница 133: ...also allows the entry of lot number and expiry date of the fluids in the kit This information is stored in the database by clicking on the printer icon which also will print out a label to the label printer File Management This button accesses the means to add or subtract assay files Assays are stored on a flash drive which must be inserted into one of the three USB ports located near the power sw...

Страница 134: ...File Management Screen Transfer files The drop down menu has four available functions The first is the ability to load files from the USB flash drive to the Agility system or from the folder C assays on the hard drive Clicking on the Current USB Device will toggle between the two locations ...

Страница 135: ...t uses the same SKD SmartKit Definition file Clicking on the white down arrow on the gray title bar will bring up any multiple assays assigned to that SKD One should always be designated as active through the radio button that when selected will be green If the Hide selection is checked that assay will not be displayed when the SmartKit is inserted into the system If none are hidden the user will ...

Страница 136: ...a particular assay Any profiles created will appear in the drop down list If the Use Assay selection is made reports will be produced from the assay as originally created with Assay Editor The Scheduler Incubation Window will give the scheduler more flexibility for complex worklists that may have steps that often overlap with the nominal incubation time Instrument Configuration This button accesse...

Страница 137: ...ace These are wav files that may be found here C ProgramData Dynex Technologies Sounds alert wav C ProgramData Dynex Technologies Sounds error wav If a different sound is wanted new wav files can be put in these locations with those same names The user may also specify how long is permitted to unload an ejected rack or load a requested rack If the user does not respond before these times the opera...

Страница 138: ...pter 6 The Graphical User Interface 138 Agility System Operator s Manual Figure 6 36 User Configuration Laboratory Information The information on this input screen will be inserted into reports if desired ...

Страница 139: ...ration The reader filters are configured at the factory but may be changed This screen designates where the new filters are inserted on the filter wheel The criteria for what is displayed as an Over reading and how to specify what value should be provided for either Over or Under is also configured here ...

Страница 140: ...port Profiles Report profiles can be set up and saved using this screen Multiple profiles can be associated with any assay Using the input for Over Incubation Tolerance any incubation that runs longer than the nominal assay definition according to this input will be inserted into the report ...

Страница 141: ... Figure 6 39 Over Incubation Warning If the Report Profile is not used for reporting the default report format defined in the assay will be used The input shown above will insert a warning if any incubation runs longer than the nominal assay definition according to this input ...

Страница 142: ... Graphical User Interface 142 Agility System Operator s Manual Figure 6 40 Logging Purge Setting As logs can be quite lengthy and consume a lot of disk space the setting shown here will continuously purge older logs ...

Страница 143: ...tor s Manual 143 Chapter 7 Error Handling 7 1 Introduction The user will be presented with error message screens should there be a problem in operation The display will guide the user to the proper actions Figure 7 1 Example Error Recovery Dialog ...

Страница 144: ...Chapter 7Error Handling 144 Agility System Operator s Manual This page intentionally left blank ...

Страница 145: ...tubes or deep well plates Sample Pipetting Precision 3 CV at any operating volume above 10 µL Sample Pipetting Accuracy 2 of target volume Dilution Range 1 part in 199 one stage solution 1 part in 39 601 two stage solution Number of Sample Tips 20 racks of 112 tips additional racks can be added using continuous load capacity Sample Tube Dimensions 10 17 mm diameter external dimension 40 100 mm dep...

Страница 146: ...Manifold Configuration 8 way wash head Programmable Volumes 50 999 µL Wash Containers 4 wash bottles at 3 0 L with quantitative level sensing Clean Container 1 wash bottle at 3 0 L with quantitative level sensing Waste Container 10 L with quantitative level sensing Residual Wash Volume 3µL per well with dual axis sweep in a flat bottom well Dispense Precision 5 CV with 300 µL in a 96 well plate A ...

Страница 147: ...0 1 2001 IEC 61010 2 101 Lead free All components are RoHS compliant IVDD CE marked per IVD 98 79 EC Directive A 8 System Dimensions Width 1250 mm 49 Depth 900 mm 35 Height 1230 mm 48 Footprint 1200 x 650 mm 47 x 27 Bench Weight 213 kg 469 lb max Ship Weight 296 kg 650 lb max Noise Noise Output 80 dB A 9 Power Requirements Voltage 100 240V automatic switching Frequency 50 60 Hz Power Consumption 4...

Страница 148: ...Appendix A Specifications 148 Agility System Operator s Manual This page intentionally left blank ...

Страница 149: ...ell Strips 67951 Mixing Well Strips Blue 67910 Sample Tips Box of 896 67920 Reagent Tips Box of 196 67930 Dilution Tray Holder With Barcode Label 67940 Mixing Tray Holder With Barcode Label 24901041 Reagent Rack Holder 13501500 Assembly Plate Carrier 65940 Vials Control With Caps Pack of 33 62920 Tubes Reagent 25ml Pack of 10 24902350 Bronze Kit Insert 24902360 Bronze Kit Trough 67930 Dilution Tra...

Страница 150: ...Appendix B Consumables and Spare Parts 150 Agility System Operator s Manual This page intentionally left blank ...

Страница 151: ...he limit of DYNEX TECHNOLOGIES liability Furthermore DYNEX TECHNOLOGIES shall not be liable for incidental or consequential damages Failure of the Customer to notify DYNEX TECHNOLOGIES of a claimed defect by registered mail within thirty days of the discovery thereof shall constitute a waiver of any claim for breach of warranty When a product is required by DYNEX TECHNOLOGIES to be installed by a ...

Страница 152: ...N AND ACCEPTED IN LIEU OF ANY AND ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING WITHOUT LIMITATION THE IMPLIED WARRANTY OF MERCHANTABILITY AND THE IMPLIED WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY INCIDENTAL INDIRECT SPECIAL OR CONSEQUENTIAL DAMAGES ...

Страница 153: ...s 105 Front Doors 41 G Graphical User Interface 97 H Home 105 I Incubator Screen 115 Initialize All Modules button 99 Introduction 9 L Lamp Assembly Replacing 88 Liquid Level Detection 29 Loading Consumables 54 63 Loading Microplates 66 Loading Reagent Tip Racks 66 Loading Samples 54 Loading SmartKits 65 Log Viewer 105 Logout button 103 Lower Workspace 25 M Maintenance 83 Microplate Reader 39 Micr...

Страница 154: ...ts 105 SmartKits Screen 112 SmartKitTM 10 Specifications 145 Spreadsheet 128 Spreadsheet Table 121 Status Screens 117 Stop 129 Stop the System 129 Stopping the System 78 System Decontamination 86 System Design 25 T Temperature Incubators 40 Threshold table 124 Threshold Table 121 Timeline 105 108 Timeline Screen 117 Tip Detection 29 Tip Waste 15 Transport Arm 27 Tubing Replacing 92 U Upcoming Task...

Страница 155: ...com Dynex Technologies Ltd Columbia House Columbia Drive Worthing West Sussex BN13 3HD England Tel 44 0 1903 267555 FAX 44 0 1903 267722 E mail adminuk dynextechnologies com Dynex Technologies GmbH Heerweg 15D 73770 Denkendorf Germany 49 0 711 900349 66 Phone 49 0 711 900349 68 Fax E mail dynexgermany dynextechnologies com Dynex Technologies Inc 701 7 F Tower 2 Silvercord 30 Canton Road Tsim Sha T...

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