manual de operador manual lumatic 4401

7/23/2019 Manual de Operador Manual Lumatic 4401

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Model 4401

OOPPEERR A ATTOORR’’SS MM A ANNUU A ALL

Doc 4401 09/2010 Rev A www.monobind.com



TABLE OF CONTENTS

1. INTRODUCTION.................................................................................................................................... 1

1.1 APPLICATIONS....................................................................................................................................... 1 1.1.1 Intended Use.................................................................................................................................. 1 1.1.2 Summary of the Instrument............................................................................................................ 1

1.1.3 Key Features.................................................................................................................................. 2 1.1.4 Principles of Operation ................................................................................................................. 2 1.2 WARNING MARKINGS I NSCRIPTIONS D’AVERTISSEMENT ...................................................................... 3

1.2.1 Safety Symbols Le Symboles de Sûreté .......................................................................................... 3 1.2.2 Safety Terms Terminologie de Sûreté .......... ........... ........... ........... ........... .......... ........... ............ ..... 4

1.3 SAFETY PRECAUTIONS........................................................................................................................... 5 1.4 OPERATING PRECAUTIONS .................................................................................................................... 7

1.4.1 Instrument Warm Up Time ............................................................................................................ 7

2. TECHNICAL SPECIFICATIONS ......................................................................................................... 8

3. INSTALLATION ................................................................................................................................... 10

3.1 U NPACK I NSTRUMENT......................................................................................................................... 10 3.2 PARTS AND CONTROLS ........................................................................................................................ 12

3.2.1 Parts of the Instrument ................................................................................................................ 12 3.3 I NSTRUMENT SETUP & SOFTWARE I NSTALLATION .............................................................................. 14

3.3.1 Software Installation.................................................................................................................... 14 3.3.2 USB Port Connection .................................................................................................................. 16

3.4 I NSTRUMENT CHECK OUT ................................................................................................................... 17

4. OPERATING PROCEDURES ............................................................................................................. 18

4.1 GENERAL SELECTIONS ........................................................................................................................ 18 4.1.1 Selecting a Plate Format ............................................................................................................. 19

4.2 ASSAY MODES .................................................................................................................................... 20 4.2.1 RLU Mode ................................................................................................................................... 21 4.2.2 Factor Mode................................................................................................................................ 21 4.2.3 Standard Mode ............................................................................................................................ 22

4.2.4 % RLU Mode............................................................................................................................... 22 4.2.5 Point-to-Point Mode.................................................................................................................... 23 4.2.6 Polynomial Regression Mode...................................................................................................... 25 4.2.7 Linear Regression Mode.............................................................................................................. 26 4.2.8 Dose Response Mode................................................................................................................... 27 4.2.9 Cubic Spline Mode....................................................................................................................... 27 4.2.10 Cutoff Mode............................................................................................................................... 28

4.3 RLU NORMALIZATION ........................................................................................................................ 30 4.4 TWO POINT (2PT) CALIBRATION......................................................................................................... 31

5. LUMATIC™ MANAGER..................................................................................................................... 34

5.1 OPENING LUMATIC™ MANAGER ........................................................................................................ 34 5.1.1 Password Security and Logging In.............................................................................................. 35 5.1.2 LuMatic™ Manager Toolbar Icons............................................................................................. 36

5.2 MAIN MENU SELECTIONS & FEATURES............................................................................................... 37 5.2.1 Management Menu ...................................................................................................................... 37 5.2.2 Tests Menu................................................................................................................................... 38

5.2.2.1 Read Plate RLUs.................................................................................................................................... 38 5.2.2.2 Create Assay .......................................................................................................................................... 39 5.2.2.3 Edit Assay.............................................................................................................................................. 42

5.2.3 Lot # Registration Menu.............................................................................................................. 43 5.2.4 QC Tracking Menu...................................................................................................................... 44



5.2.5 Sample Database ......................................................................................................................... 46 5.2.5.1 Add to Sample Database........................................................................................................................ 46 5.2.5.2 Modify Sample ID ................................................................................................................................. 48 5.2.5.3 Delete Sample ID................................................................................................................................... 48 5.2.5.4 View Log ............................................................................................................................................... 49 5.2.5.5 Import Patient Record ............................................................................................................................ 50 5.2.5.6 Export Patient Record ............................................................................................................................ 51

5.2.5.7 Search Patient Record............................................................................................................................ 51 5.2.5.8 Choose Patient Record........................................................................................................................... 52 5.2.6 Settings ........................................................................................................................................ 53

5.2.6.1 Comm Port, Database, Report Settings.................................................................................................. 53 5.2.6.1.1 Software Settings............................................................................................................................ 54

5.2.6.1.1.1 Start up .................................................................................................................................... 54 5.2.6.1.1.2 Sample Database Settings ....................................................................................................... 55 5.2.6.1.1.3 Report Appearance.................................................................................................................. 56 5.2.6.1.1.4 Report Output.......................................................................................................................... 57

5.2.6.2 Custom Report Settings ......................................................................................................................... 58 5.2.6.2.1 Custom Report Sample................................................................................................................... 59

5.2.6.3 Select Language..................................................................................................................................... 60 5.2.7 Maintenance ................................................................................................................................ 61

5.2.7.1 Firmware Update ................................................................................................................................... 61 5.2.7.2 LuMatic™ Calibration Lock/Unlock ..................................................................................................... 62

5.2.8 Security Menu Options ................................................................................................................ 63 5.2.9 Help ............................................................................................................................................. 66

5.3 LUMATIC™ MANAGER TABS.............................................................................................................. 67 5.3.1 Plate Layout Tab ......................................................................................................................... 68 5.3.2 Assay Calibration ........................................................................................................................ 70

5.3.2.1 Adjusting Curves by a Percentage Factor .............................................................................................. 75 5.3.2.2 Using Stored Curves .............................................................................................................................. 76

5.3.3 Add Samples Tab ......................................................................................................................... 78 5.3.4 Test Results Tab........................................................................................................................... 80 5.3.5 Report Tab................................................................................................................................... 82

6. TROUBLESHOOTING......................................................................................................................... 85

6.1 ERROR MESSAGES ............................................................................................................................... 85

6.2 COM PORT SETTINGS ......................................................................................................................... 88 6.2.1 PC Communication (COM) Port Setting..................................................................................... 88 6.2.2 LuMatic™ Communication (COM) Port Setting......................................................................... 90

7. CONTACT INFORMATION ............................................................................................................... 93

8. APPENDIX ............................................................................................................................................. 94

8.1 LABORATORY I NFORMATION SYSTEM (LIS) ....................................................................................... 94



Monobind LuMatic™

Model 4401 Operator’s Manual Rev. A 1

1. INTRODUCTION

1.1 Applications

1.1.1 Intended Use

The LuMatic™ Model 4401 CLIA Microplate Reader is a laboratory instrumentintended for in-vitro diagnostic use. It is a user-programmable open system withselectable plate formatting, alphanumeric test naming, automatic interpretationoptions, duplicate well options, curve plotting and editing, and flags and errormessages.

The LuMatic™ Model 4401 CLIA Microplate Reader is a general purposeinstrument intended to be used by trained laboratory professionals who arecapable of selecting the appropriate features and options for each specific clinicalapplication. Contact your company’s instrument service provider to arrange fortraining.

WARNING! FOR IN-VITRO DIAGNOSTIC USE

AVERTISSEMENT! POUR L'USAGE DIAGNOSTIQUE IN VITRO

1.1.2 Summary of the InstrumentThe LuMatic™ Model 4401 CLIA Microplate Reader is a platechemiluminescence analyzer optimized for Monobind’s AccuLite

® reagent line

and an excellent plug-in for Monobind’s AutoPlex™ Automated ELISA and CLIA Analyzer. LuMatic™ software allows the operator to create, edit and storeassays. Standard curves are also stored in this memory. Test protocols remainstored until either changed or deleted by the user.

The LuMatic™ Model 4401 CLIA Microplate Reader offers all the benefits of

CLIA technology: sensitivity, speed, and dynamic range. With LuMatic™ and

AccuLite®, Monobind gives you an open-system CLIA platform with a 45+ testmenu. Raw data RLU readings and calculation modes such as single pointcalibration, point-to-point curve fit, multipoints, polynomial regression, linearregression (log & linear), cubic spline and cutoff modes are offered. The basiccalculations are permanently stored in memory and include several single andmulti-point equations. Each calculation mode is described in detail in Section4.2-Assay Modes. Provisions are made in certain cases for reading specimensin duplicate and/or using the mean reading in calculations.

The LuMatic™ Model 4401 CLIA Microplate Reader reads a 96-well microplateand calculates results instantly and automatically; and it accepts all standardmicroplates. Trays containing microstrips may also be read. The robustness of

AccuLite® allows for two-point calibration enabling laboratories to run more

patient samples per plate, reducing reagent use and overall test cost. LuMatic™and AccuLite

® offer a convenient and affordable package designed to bring high

quality immunoassays to markets worldwide.



2 Monobind LuMatic™

Model 4401 Operator’s Manual Rev. A

The LuMatic™ Model 4401 CLIA Microplate Reader is a user-friendly instrumentcertified by Monobind to ensure the optimal performance of AccuLite

® reagents

giving users the very best in CLIA testing. Built-in references further maintainpeak function with continuous instrument calibration.

The LuMatic™ Model 4401 CLIA Microplate Reader uses the power and

efficiency of your PC to deliver sophisticated data analysis, curve fitting, reportingand data storage. It is based on the same software as Monobind’s Autoplex™ Analyzer, and may be used together with a single interface. Simply connect via

USB and load the LuMatic™ software containing the device manager and AccuLite test data. Then select desired assay(s) and start running AccuLite

®

CLIA right away.

1.1.3 Key Features Drag and drop test selection to easily format plate

Multiple analytes per plate (up to 12)

Two-point calibration using stored curve

Storage of unlimited protocols (only limit is PC memory)

Full support of kit lot numbers

Storage of assay results, allowing offline re-evaluation

Curve plotting and editing

Open instrument for use with other CLIA assays

1.1.4 Principles of OperationThe plate carrier precisely positions each well to be read by the fiber optic. Lightenergy is then collected from the sample through a fiber optic cable. The light is

directed to a photomultiplier (PMT). The PMT converts the transmitted lightenergy into an amplified electrical signal, which can be interpreted by comparisonwith signals from known concentrations.

Upon entering a Test Mode, calibration is checked to an internal LED to ensureconsistent equipment calibration.



Monobind LuMatic™


1.2 Warning Markings Inscriptions d’avertissement

1.2.1 Safety Symbols Le Symboles de Sûreté

Symbols that may appear on the product:

Les symboles de sûreté peuvent apparaitre sur le produit:

WARNING Protective Ground CAUTION BIOHAZARD AVERTISSEMENT La Terre Electrique L’ATTENTION BIOHAZARD

Risk of Shock (Earth) Terminal Refer to Manual Risk of Infection Risque de Choc Prise de Terre Se Rapportent Risque d’infection

a Manuel

FUSE: For continued protection against risk of fire, replace fuse only with one ofthe specified type and current ratings. Disconnect equipment from power supplybefore replacing fuse.

FUSIBLE: Pour la protection continue contre le risque du feu, remplacez lefusible seulement par une du type spécifique et des estimations courantes.Démontez l’équipement de l’alimentation d’énergie avant de remplacer le fusible.





1.2.2 Safety Terms Terminologie de Sûreté

These terms may appear on the product:Les marques sur le produi t:

DANGER

DANGER Le “de marque:DANGER”

indicates an injury immediatelyaccessible as you read this marking

indique le risque immédiat de dommages(assessible tandis que vous lisez lamarque)

WARNING

AVERTISSEMENT! Le “ demarque: WARNING”

indicates an injury hazard notimmediately accessible as you read thismarking

indique qu’un risque de dommages quin’est pas immédiat alors vous lisent cette

marque

CAUTION

L’ATTENTION “ Le demarque: CAUTION”

indicates a hazard to property, includingthe product

indique un risque a la propriétécomprenant ce produit

These terms may appear in this manual:Les marques dans l’opérateur manuel:

WARNING

AVERTISSEMENT! Le “ demarque: WARNING”

WARNING statements identify conditionsor practices that could result in injury orloss of life. WARNING indicates an injuryhazard not immediately accessible as youread this marking.

Ces rapports identifient les conditions oules pratiques qui pour raient avoir commeconséquence les dommages ou lespertes humaines.

CAUTION

L’ATTENTION “ Le demarque: CAUTION”

CAUTION statements identify conditions

or practices that could result in damageto this product or other property.

Ces rapports identifient les conditions oules pratiques qui pour raient avoir commeconséquence les dommages a ce produitou a toute autre propriété.



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1.3 Safety Precautions

To assure operator safety and prolong the life of your instrument, carefully follow allinstructions outlined below.

• Read Instructions Please take the time to read this manual carefully before usingthis instrument. Review the following safety precautions to avoid injury and preventdamage to this instrument or any products connected to it. To avoid potentialhazards, use this instrument only as specified. For best results, familiarize yourselfwith the instrument and its capabilities before attempting any clinical diagnostic tests.Refer any questions to your instrument service provider.

• Servicing There are no user-serviceable parts inside the instrument. Refer servicingto qualified service personnel. Use only factory-authorized parts. Failure to do somay void the warranty.

• Wear Protective Apparel Many diagnostic assays utilize materials that are potentialbiohazards. Always wear protective apparel and eye protection while using thisinstrument.

• Follow Operating Instructions Do not use this instrument in a manner not specifiedby the manual, or the protection provided by the instrument may be impaired.

• Use Proper Power Cord Use only the power cord specified for this product andcertified for the country of use.

• Ground the Product This product is grounded through the grounding conductor ofthe power cord. To avoid electric shock, the grounding conductor must be connectedto earth ground. An optional method is to attach a ground strap from the externalgrounding terminal on the rear panel of the instrument to a suitable ground such as agrounded pipe or some metal surface to earth ground.

Warning!

Avertissement!Warning! To avoid electric shock, the grounding conductor inthe supply cord must be connected to earth ground. Anoptional method is to attach a ground strap from the externalgrounding terminal on the rear panel of the instrument to asuitable ground such as a grounded pipe or some metalsurface to earth ground.

Avert issement ! Pour évi ter la décharge élec tr ique, vous devezemployer la corde de principal courant avec la terre électrique(prise de terre). Vous pouvez attacher un bus de masse duterminal a terre externe sur le panneau arrière de l’instrumentdans une p ipe fondée des eaux.





• Observe All Terminal Ratings To avoid fire or shock hazard, observe all ratingsand markings on the instrument. Consult this manual for further ratings informationbefore making connections to the instrument.

• Install as Directed Install the instrument on a sturdy, level surface capable ofsafely supporting the instrument’s weight 12.5 lbs (5.657 kg). The mounting surface

should be free of vibrations. The instrument does not require fastening to the benchtop.

• Provide Proper Ventilation Refer to the installation instructions for details oninstalling the product so it has proper ventilation. Provide a minimum 3 inchclearance (8cm) at the back of the instrument.

• Do Not Operate Without Protective Covers Do not operate this instrument withcovers and panels removed.

• Use Proper Fuse Use only the fuse type and rating specified by the manufacturer forthis instrument.

• Avoid Exposed Circuit ry Do not touch exposed connections and components whenpower is present.

• Avoid Excessive Dust Do not operate in an area with excessive dust.

• Do Not Operate With Suspected Failures If you suspect there is damage to thisinstrument, have it inspected by a qualified service person.

• Do Not Operate in Wet/Damp Conditi ons

• Do Not Operate In An Explosive Atmosphere

• Keep Instrument Surfaces Clean and Dry Solvents such as acetone or thinner willdamage the instrument. Do not use solvents to clean the unit. Avoid abrasive

cleaners. Clean the exterior of the instrument with a soft cloth using plain water. Ifneeded, a mild all-purpose or nonabrasive cleaner may be used. Use as adisinfectant a 10% solution of chlorine bleach (5.25% Sodium Hypochlorite) or 70%isopropyl alcohol. Take special care not to spill liquid inside the instrument.



Monobind LuMatic™


1.4 Operating Precautions

NOTE: Insufficient RAM will adversely affect the performance of your instrument. ForMicrosoft

® Windows XP, the recommended minimum amount of RAM is 512 MB.

• Avoid lifting, leaning or turning the instrument over when a plate is in place.

• Be sure to run a sufficient number of controls in each assay. If controls are not withintheir acceptable limits; or if incomplete, disregard test results.

Biohazard Precautions

Warning!

Avertissement!

WARNING: If any materials are overturned during operation,immediately set the power switch to OFF (0). This material shouldbe treated as potentially biohazardous. Appropriate cleanup anddisposal of biohazardous waste should be used.

Avert issement ! Lors du fonct ionnement, si on renverse desmatériaux, coupez immédiatement le courant. Placez lecommutateur électrique a AU LOIN(0). Traitez le matérielcomme biohazardous, utilisant approprie nettoient et desméthodes de disposition.

1.4.1 Instrument Warm Up Time

It is advisable that the LuMatic™ Model 4401 CLIA Microplate Reader be turnedon for a 30 minute warm up before use. This gives the instrument time to warmup and stabilize.





2. TECHNICAL SPECIFICATIONS

The plate moves toward the front and back of the instrument.

Depending on the setup, reports may be displayed or printed to create permanent labrecords and physician reports.

• Optical:

Detection Mode: Glow Luminescence

Sensitivity/Detection limit: HRP 1x10-18

moles, ALP 1x10-21

moles

Linear Dynamic Range: 106 RLU

Cross talk: Less than 2.5 x 10-4

Detector: Photomultiplier (PMT)

Spectral Response Range: 300-650 nm

Peak Wavelength: 400 nm

Vessel: 96 wells in opaque strip tray or plate

• Electronic:

Power Requirements: 100 - 240VAC, 50-60Hz 90W maximum. All power cords must be approved for thecountry of use

PC Connection: USB Port

Microprocessor: eZ80

Speed: Reads 96 wells in approximately two minutes

Plate Transport: Stepper motor

Certifications: NRTL Listed, CE mark



Monobind LuMatic™


• Software:

PC interface with LuMatic™ Manager software – inc luded (PC not included)

Features: PC interface software (included) withcomplete user prompting, error messages, fullplate reporting, automatic interpretation

options, duplicate options, controls locator,curve plotting and editing

Format: CD-ROM and internet upgrades

Operating Systems: Microsoft® Windows XP, Vista or Windows 7

Minimum System: Microsoft® Windows XP 256 RAM; USB port

Secondary menu options: Create/edit protocols, import/export data, LIS

Calculation modes: RLU, Factor, Standard, %RLU, Point to Point,Polynomial Regression (2

nd, 3

rd, and 4

th

order), Linear Regression (log & linear), Dose

Response, Cubic Spline, Cutoff modes

Additional Features: User-programmable open system, selectableplate formatting, reporting

QC options: Store control data, print Levey-Jennings orQC range plots, calculate SDs

USB port: USB cable provided

• Physical

Enclosure: All metal enclosureDimensions: 7.5” x 8.0” x 16.5”(19x20.3x42cm)Weight: 12.5 lbs (5.7 kg)

• Environmental

Operating Temperature: 15 to 35◦

C

Humidity: Between 10 and 85% non-condensing

Storage Temperature: 10 to 50◦

C

Altitude: 2000m maximum

Design and instrument specifications are subject to change without not ice.





3. INSTALLATION

3.1 Unpack Instrument

Carefully unpack the instrument, removing it from its plastic bag. Report any damageto your freight carrier at once. The box will also contain the Operator’s Manual, a

power cord, a USB cable, and a USB mass storage device.

NOTE: Retain the original packing material for future use in the event that theinstrument is shipped to another location or returned for service.

Unpacking Checklist

Quantity Description

1 Customer copy of packing list

1 Unpacking instructions sheet

1 Certificate of Conformity

1 Certificate of Quality

1 Instrument Set Up and Operator’s Manual

1 Power cord

1 USB cable

1 USB mass storage device

Instrument Mounting and Use

Place the instrument on a flat working surface capable of safely supporting theinstrument’s weight of 12.5 lbs (5.7 kg). Excessive vibration during reading maycause poor repeatability; thus, a sturdy working surface is required. A minimum of atleast 3 inches (8cm) clearance around the instrument is required to assure optimalventilation.

Power Switch Posit ion When installing the power cord the unit should be turned off. Look at the rear panelof the instrument to check that the power switch is in the OFF position. A diagram ofthe rear panel can be found in the Section Parts and Contro ls.

Power Cord Requirements Use only the power cord specified for this product and certified for the country of use.For 110-120 V units used inside the US use a UL listed cord set consisting of aminimum 18 AWG, Type SVT or SJT three conductor cord, maximum 3 meters (10feet) in length, rated 10 A, 125 V, with a parallel blade, grounding type attachmentplug.

For 220-240 V units used inside the US use a UL listed cord as above, except rated250 V, with a tandem blade, grounding type attachment plug. The cord set providedby the manufacturer meets these requirements.



Monobind LuMatic™


Safety GroundingDo not alter or defeat the safety grounding methods provided. To avoid the risk ofelectric shock, the third prong of the AC power plug must be connected to conductiveparts internal to the equipment. Internal fasteners to grounding points are marked by

the IEC 417 symbol 5019 . DO NOT loosen or remove these fasteners or

connections. An alternate method of grounding is provided by connecting thegrounding terminal located on the rear panel, to a suitable ground.

To avoid electric shock, the power cord protection ground conductor must beconnected to ground.

Assure Clean Power Availabi li tyThe circuit used should be substantially free of large voltage transients (Kilovolt amploads) such as large pumps, large centrifuges, refrigerators and freezers, airconditioners, large autoclaves, ovens, and dryers. The instrument may fail to operatenormally if the power supply is interrupted. If this occurs, turn the instrument off for amoment. When the instrument is turned back on, it will resume normal operation, buta standard curve which was not stored in non-volatile memory will be lost.

Fuse Requirements The fuses are located internally in the instrument; there are two fuses. Fuse number1 is located on the main printed circuit board near power connector J4. It is a 4 Amp,medium acting, 250V, 5 x 20mm, Littlefuse type 0234004 or equivalent. Fuse number2 is located on the power supply. It is a 2.5 Amp, fast acting, 250V, 5 x 20mm,Littlefuse type 21602.5P or equivalent.

Fuse failure is a very rare occurrence and may indicate malfunction of the equipmentrequiring service by qualified personnel.

Warning!

Avertissement!

FUSE

FUSIBLE

Warning! For continued protection against risk of fire, usethe correct fuse. Disconnect power cord from mains supplybefore replacing fuses.

Avert issement ! Pour la protection cont inue contre le r isquedu feu, remplacez le fusible seulement par une du type

spécifique et des estimations courantes. Démontezl’équipement de l’alimentation d’énergie avant deremplacer le fusib le.





3.2 Parts and Controls

The following labeled diagrams illustrate the terms used in this manual to describe parts

and controls of the LuMatic™ Model 4401 CLIA Microplate Reader. More details on theoperation of each feature are provided in Section 4-Operating Procedures.

3.2.1 Parts of the Instrument

Figure 3.2.1-1 Front of Instrument

Figure 3.2.1-2 Door open, tray out

A) Door

B) IndicatorlightB A

A) Tray out(extended)

B) Indicatorlight

C) Door open A

C

B



Monobind LuMatic™


Figure 3.2.1-3 Back of Instrument

C) USBConnection

A

CB

A) Power switch

B) Power cordconnection





3.3 Inst rument Setup & Software Installation

IMPORTANT NOTE:

AS WITH MANY USB DEVICES IT IS CRITICAL THAT YOU DO NOT CONNECT THEUSB CABLE TO THE LUMATIC™ OR COMPUTER UNTIL THE SOFTWARE HASBEEN INSTALLED. DOING SO MAY AFFECT THE INSTALLATION OF THE

APPLICABLE DRIVERS NEEDED TO RUN LUMATIC™ MANAGER.

Follow the steps in Section 3.3.1 Software Installation and then reference Section 3.3.2for USB port connectivity.

3.3.1 Software InstallationTurn on the computer and insert the Compact Disk (CD) supplied with the instrumentinto the computer’s CD drive. Double-click on the setup.exe to begin Setupinstallation. Follow the prompts for installing the program and the communicationsport drivers.

Steps Prompts/Screen Display

Double-click onsetup.exe to beginSetup

Figure 3.3.1-1 Double-Click to Begin Setup



Monobind LuMatic™



Setup process begins with the Welcome screen:

And then the opportunity to select the destination folder default or choose another folder:

LuMatic™ ManagerIcon





The PC COM port setting does not require an adjustment before activating

LuMatic™ Manager . However, instructions on how to view and adjust the setting areprovided in Section 6.2.1 PC Communication (COM) Port Setting.

The LuMatic™ COM port setting does not require an adjustment to match thecomputer’s COM Port setting. However, steps have been provided in Section 6.2.2

LuMatic™ Communication (COM) Port Setting to view/adjust the setting ifnecessary.

3.3.2 USB Port ConnectionUsing the USB cable provided, connect the computer’s USB port to the LuMatic™USB port (reference Figure 3.3.2-1 Back of Instrument).

USB cable

Figure 3.3.2-1 Back of Instrument

A

Connect to theUSB portconnection on theback of the

LuMatic™instrument ( A)

Connect to thecomputer’s USBport



Monobind LuMatic™


3.4 Instrument Check Out

Follow the instructions under the Instrument Setup & Software Installation section to

ensure that the LuMatic™ Manager software is installed and the computer and the

LuMatic™ Model 4401 CLIA Microplate Reader are powered on.

NOTE: If it is necessary to view / adjust the communication port settings of the computerand the LuMatic™ instrument refer to the instructions found under Section 6.2 - COMPort Settings.

When the LuMatic™ instrument powers up, note the following actions:

The instrument annunciates a beep sound

The LED power indicator will light (light will flash/pulse)

The instrument will perform an initialization process and annunciate three shortbeeping sounds signaling it is operational

If the instrument powers up, but the actions described above do not occur, check the

USB cable connections and COM port settings.





4. OPERATING PROCEDURES

Section 4.1 – General Selections provides questions for review before beginning a test,and information about plate format selection

Section 4.2 - Assay Modes mode-specific description for each general purpose

calculation program

4.1 General Selections

For every test, the instrument will require a mode selection. Thereafter, only thosequestions that pertain to the mode selected will be asked. In the RLU mode, forexample, there are no further selections required.

Review the following questions before beginning a test (refer to the CLIA kit insert forrequired information):

1. What calculating program will be used?

2. Is a blank required? Desired?

3. How many calibrators will be used?

NOTE: For the purpose of this manual, the terms calibrator and standard areused interchangeably to designate reference materials of knownconcentrations

4. What is the calibrator value or values?

5. Will calibrators and /or specimens be read in duplicate, or singly?

NOTE: For the purpose of this manual, the terms specimen and sample areused interchangeably to mean materials of unknown concentrations.

6. Will locations of 1 or more controls be marked? If so, indicate plate number,row number, and well number for each.

7. Will acceptance cutoffs or ranges for controls be entered for automaticcomparison? If so, what cutoffs or ranges are to be used for each?

8. Will a cutoff value be used to label positive samples? If so, the value whichbegins the positive range will be required.

9. Will a cutoff value be used to label negative samples or define an equivocalzone? If so, results less than what cutoff should be labeled as negative?



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4.1.1 Selecting a Plate FormatOpaque microplates can be read in either the left/right direction (8 well strips) orin the front/back direction (12 well strips) beginning at well A-1.

It may be necessary to switch formats in order to perform assays from different

manufacturers. LuMatic™ software can be configured for reading and

presenting data using either format.

Selecting a Plate Format: Description

To begin, ensure that the LuMatic™ isconnected via USB cable to your personalcomputer (see Section Instrument Setup &Software Installation) and power up theinstrument.

The instrument will annunciate a beepingsound; the LED power indicator will light(the light will pulse/flash); and the

instrument will warm-up.

When the instrument has completed itsinitialization process, it will annunciatethree short beeping sounds signaling it isoperational.

Click on the LuMatic™ Manager icon:

The Plate Layout screen will display on thePC monitor.

The plate format is chosen by clicking onthe 8-way or 12-way buttons. Once aformat is selected, it stays selected untilthe user changes it.

Click tochoose8 way

or12 wayplate

format:

PlateLayout

screen:





4.2 Assay Modes

The LuMatic™ software contains several pre-programmed general-purposecalculations selected to facilitate data handling for enzyme immunoassays and othersimilar tests.

Access the Assay Modes viaLu

Matic

™ Manager Tests Menu (refer to Section5.2.2)

RLU

Factor

Standard

% RLU

Point to Point

Polynomial Regression (Polynomial 2nd

, 3rd,

4th

Order)

Linear Regression

Dose Response

Cubic Spline

Cut Off



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4.2.1 RLU Mode

RLU Mode Descrip tion:

The LuMatic™ Model 4401 CLIA Microplate

Reader reads and prints RLUs.

Blanking is optional.

4.2.2 Factor Mode

Factor Mode Descrip tion:

In Factor Mode, the instrumentreads and calculatesconcentrations by multiplyingthe RLU readings by the usersupplied factor.





4.2.3 Standard Mode

Standard Mode Descrip tion:

The instrument first accepts a calibrator

read singly or in multiple numbers and thencalculates concentrations based on a single-point standard curve passing through thepoint (0,0).

A blank is required to determine the (0,0)point.

4.2.4 % RLU Mode

% RLU Mode Descrip tion:

This mode is a point-to-point calibrationmode which calculates a % RLU for eachsample and calibrator in addition to aconcentration value.

The highest calibrator is assigned a valueof 100% and each sample and calibratoris calculated as a percentage of this value

and displayed in the Interpretation field ofthe report. This mode does not support ln,logit or log scales for the RLU axis.

The instrument accepts a number ofcalibrators (from 2 to 30) read singly or inmultiple numbers.

Blanking, graphing, and editing optionsare available.



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4.2.5 Point-to-Point Mode

Point to Point Mode Descrip tion:

The instrument accepts a number ofcalibrators (from 2 to 30) read singly or inmultiple numbers.

It then calculates concentrations based onthe point-to-point calibration curve.

Data may be entered for linear-linear, ln ( = natural log)-linear,linear-ln, or ln-ln calculations.

Blanking, graphing, and editing optionsare available.

NOTE: Assay axis types areavailable under other regressionmodes as well.

Assay Axis Types:

Data may be entered for linear-linear,ln (= natural log)-linear, linear-ln, or ln-ln calculations. A logit-log calculation isalso available. RLUs, or ln of (1000 *RLU), is always on the “Y” axis.Concentration, or ln of concentration, isalways on the “X” axis.

1. “ Y= RLU, X=CONC” - both the RLUdata (y) and the concentration data(x) are linear.

2. “ Y=Ln (1000*RLU), X=Conc” - thenatural log of the RLU reads isplotted against the concentration.The values are multiplied by 1000before taking the logs.

3. “ Y=RLU, X=Ln(Conc)” – RLUs readsareas plotted against the natural log ofthe concentration.

4. “ Y= Ln (1000*RLU), X=Ln(Conc)” -the natural log of the RLU reads isplotted against the natural log of the

concentration.





Point to Point Mode (Continued)

Point to Point Mode (Continued) Descrip tion:

5. Select “ Y= Logit (RLU), X=

Log(Conc)” to calculate unknowns

using the equation: RLU Logit = Ln

[(sample/0 cal) / 1-(sample/0 cal)]

When using the Logit calculation,the “0” calibrator is not plotted aspart of the curve; it is used only forthe calculations.

6. “Y=Log(1000*RLU), X=Conc” - thebase-10 log of the RLU read isplotted against the concentration.The values are multiplied by 1000before taking the logs.

7. “Y=RLU, X=Log(Conc)” – reads areplotted against the base-10 log of theconcentration.

8. “Y=Log(1000*RLU), X=Log(Conc)” --the base-10 log is plotted against thebase-10 log of the concentration.

In the Linear Regression mode, resultingconcentrations will be the same nomatter what base is used (ln or log).However, slopes and intercepts will vary.

When using a format which calculatesthe ln or log of the concentration, (do notuse 0.0 for the concentration, since ln 0and log 0 are not defined. If a 0.0concentration Calibrator is used, it will beignored when the regression iscalculated.

Note that in the logarithmic modes, anyvalues which require the log of a zero ornegative number are invalid, and willeither invalidate the curve (if in the

Calibrators) or invalidate the specimen.Likewise, when using ln of 1000*RLU,the RLU values must be nonzero andpositive.



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4.2.6 Polynomial Regression Mode

Polynomial Regression Mode: Descrip tion:

The instrument accepts a number

of calibrators (from 3 to 30),subsequently calculatingconcentrations based upon thebest fit (polynomial regression)calibration curve.

These modes use nonlinearregression to fit the calibrationcurve to polynomial equations.The order of the polynomialequation tells you how manyterms are in the equation.

Higher order equations have moreinflection points.

Second order is defined by:

Y = A + B * X + C * X ^2

Third order is defined by:

Y = A + B * X + C * X^2 + D * X ^3

Fourth order is defined by:

Y = A + B * X + C * X^2 + D * X ^3 + E

* X ^4

Graphing and editing options areavailable.





4.2.7 Linear Regression Mode

Linear Regression Mode: Descrip tion:

The instrument accepts a number

of calibrators (from 2 to 30),subsequently calculatingconcentrations based on the bestfit (linear regression).

Data may be entered for linear-linear, ln (= natural log)-linear,linear-ln, or ln-ln calculations.

A logit-log calculation is alsoavailable.

Blanking, graphing and editingoptions are available.

RLUs, or ln of (1000 * RLU), arealways on the “Y” axis, andconcentration, or ln ofconcentration, is always on the“X” axis.



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4.2.8 Dose Response Mode

Dose Response Mode: Descript ion:

Dose Response mode uses non-

linear regression (Levenberg-Marquardt method) to fit thecalibration curve to a four-parameter logistic equationdefined by:

Y = Bottom + (Top-Bottom) / (1 +10 ^ ((LogEC50-X) * HillSlope))yielding a sigmoid curve.

The parameter “Bottom” is theRLU value at the bottom of theplateau, “Top” is the value at thetop of the plateau, and LogEC50is the concentration value halfwaybetween the “Bottom” and “Top”.

The parameter HillSlopedescribes the steepness of thecurve. When the Hillslope is lessthan 1.0 the curve is shallower,when the Hillslope is greater than1.0 the curve is steeper.

4.2.9 Cubic Spl ine Mode

Cubic Spline Mode: Descrip tion:

Cubic Spline mode accepts anumber of calibrators andcalculates concentrations basedon the Cubic Spline (Constrained)calibration curve.

The resulting calibrator curve is asmooth curve connecting thecalibrator points, which may beentered in ascending ordescending order of RLU reads. Aconstraining algorithm is appliedto prevent curve overshoot.





Cubic Spline Mode (Continued)

Cubic Spline Mode (Continued): Descrip tion:

4.2.10 Cutoff Mode

Cutoff Mode: Descrip tion:

A number of negative controls areread, followed by a number ofpositive controls.

Blanking is optional.

COV = X * mean (Nc) + F

• Use this equation if only a

negative control is used todetermine the COV.

COV = Y * mean (Pc) +F

• Use this equation if only apositive control is used todetermine the COV.

COV = X*mean (NC) + Y*mean(Pc) + F

Use this equation when

LuMatic™ must calculate the

cutoff value based uponreadings or positive and/ornegative controls.



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Cutoff Mode (Continued)

Cutoff Mode (Continued): Descript ion:

• For interpretation, you may chose either the Regular Cut Off Mode(positive >= cutoff, negative < cutoff), or the Reverse Cut Off Mode.With the Reverse Cut Off option, the Samples with values lower thanthe cut off are labeled as “positive”. If you choose this option, be

careful to follow the < and > signs in the prompts for entering cut offsand ranges.

• In this equation, NC and PC are used to determine the COV (cutoffvalue).

• Enter the variables provided in the package insert.

• LuMatic™ calculates the mean of the positives and the mean of thenegatives.

COV = X*mean (Cc) + F

• COV = cut off value for positive or negative interpretation

• X = a variable provided in the assay kit package insert. NOTE: X willequal 1 if no value of variable provided.

• mCC = the calculated mean of the RLU values of the cutoff controlswhen test is run

• Blanking is optional, dependent upon the assay kit





Cutoff Mode (Continued)

Cutoff Mode (Continued):

• F = factor added to the mCC. If needed, this value is provided in the Assay Kit package insert. If none provided, use zero for the value of

F.

• Positive and/or negative controls may be used for QC criteria.

The user may choose either the regular cutoff mode (positive >= cutoff,negative < cutoff), or the reverse cutoff mode (positive <= cutoff,negative > cutoff). The instrument calculates the mean of the positivesand the mean of the negatives.

User programmable QC Criteria is available on all controls.

4.3 RLU Normalization

The LuMatic software features an automatic standard curve normalization feature inwhich the mean of the highest standard RLU value is normalized to 100,000 RLUsand all the other standards and samples RLU readings are adjusted by the samefactor. Since a Relative Light Unit (RLU) is not a standardized unit, assay RLUvalues can vary greatly when read on different instruments. Standard curvenormalization allows chemiluminescent results read on different luminometers to bedirectly compared. The actual measured RLUs for each well are displayed in theReading field of the results database while the normalized RLU values are displayedin the RLU field of the database. See the example below:

Example - RLU values

RLUs normalized RLUs actual



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4.4 Two Point (2PT) Calibration

Two point (2PT) calibrations are available in Point to Point (Monobind AccuLite®

tests) and Regression modes.

Monobind developed 2PT calibrations to provide users efficiency and confidence in

CLIA testing. For same lot reagents with a full calibration (all standards) made in thelast thirty days, users may select 2PT calibrators and fit data (patient unknowns) to astored curve that is validated and adjusted by two calibrators (the second lowest andthe second highest: i.e. B & E in a six-standard assay or B & F in a seven- standardassay). Additionally, commercial controls should be included in the run and thedetermined values should fall within established ranges.

Figure 1 shows a standard curve (with calibrators labeled A-G) being used toascertain the concentration of TSH in unknown specimens:

Note: Due to the inherent variability in light and CLIA testing, Monobind does notrecommend the use of stored curves alone.

A

BCD

E

F

G





Two Point (2PT) Calibration (Continued)

Choose 2Pt Calibration from the Add calibration test drop down menu ( A)

Click on the Add to Plate button (B), and then add the samples to the plate (refer to

Add Samples to Tab section for more information).

A

B



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Two Point (2PT) Calibration (Continued)

After the run completes, the screen will display the curve (C) and the RLU data of thetwo adjustment points. The samples run with the 2 point adjustment will have theirread RLU values adjusted based on the RLU values of the two adjustment points.

C

Valuesof twoadjust-mentpoints





5. LUMATIC™ MANAGER

5.1 Opening LuMatic™ Manager

LuMatic™ uses the standard Microsoft® Windows controls, windows, and dialogs. Refer

to your Microsoft® Windows documentation to become familiar with these controls and

how to use them.

Ensure that the LuMatic™ Model 4401 CLIA Microplate Reader is connected via USBcable to the computer (see Section 3.3 Instrument Setup & Software Installation).

Power on the computer.

Power on the LuMatic™ instrument and wait for the initialization to complete.

Double-click on the LuMatic™ icon to open the LuMatic™ Manager software.

NOTE: It is not necessary to turn the instrument off when restarting the software.

Figure 5.1-1 LuMatic™ Manager Icon



Monobind LuMatic™


5.1.1 Password Security and Logging InWhen the LuMatic

™ Manager software is opened for the first time, a User name and

a Password must be entered.

o For User ID, type Admin

o

For Password, type Admin

There are three security access levels: Administrator, Manager, and

Operator. View Figure 5.1.1-1 for security levels. Reference Section 5.2.8Security Menu Options for security settings such as change password, createnew user, etc.

While the Stored Curve Option is available, it is not encouraged byMonobind. The Stored Curve Option should only be used by highlyexperienced technicians practicing disciplined testing procedures withminimal run-to-run variance, and must be accompanied by the use ofcontrols. Keep the installation CD in a secure location because theinstallation CD may be used to reset the Admin password.

In order to access stored curves, a security password must be established bythe Administrator for the Manager(s). Operator level access does not allow

for access to stored curve. Reference Section 5.3.2.2, Using Stored Curvesand Section 5.2.8, Security Menu Options.

Securi ty Level Administ rator Manager Operator

Disable Security Y N N

Enable Security Y N N

Create Manager Y N N

Create Operator Y Y N

Remove Manager Y N N

Remove Operator Y Y N

Change Password Y Y YView Log File Y N N

Access stored curve (referenceUse of Stored Curves section)

Y Y N

Figure 5.1.1-1 Secur ity Levels

Admin

Admin





5.1.2 LuMatic™ Manager Toolbar Icons

1 2 3 4 5

Figure 5.1.2-1 Toolbar Icons

1 Connect

2 New Assay Calibration Data

3 Lot # Registration

4 QC Tracking

5 Sample Database



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5.2 Main Menu Selections & Features

Figure 5.2-1 LuMatic™ Manager Menu Bar

5.2.1 Management Menu

OPTION DESCRIPTION

Connect Establishes or re-establishes communication between LuMatic™ software on the PC to the instrument.

Communication

Window

Opens the interactive Communication Window used for certain

diagnostics. Should only be used by trained service personnel.

LIS Import See Laboratory Information System (LIS) section in the Appendix forinformation explaining the LIS Import Option and examples of importand export files.

New AssayCalibration Data

Displays current assay calibration list.

Exit Click Exit to close the program and a dialog window will display:





5.2.2 Tests Menu

5.2.2.1 Read Plate RLUsRead Plate RLUs is accessed via the Tests Menu selection on the LuMatic™Manager Menu Bar:

OPTION DESCRIPTION

Use Blank Click on the check box if Blank is used.

Read Plate Click on the Read Plate button to activate.

Last Read Well

(Empty=Read All)

If an end of read location is desired, indicate well androw, such as F12. Otherwise, the entire plate is read.

Export Click on the Export button to send the RLU readings toNotepad, creating a .txt file:



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5.2.2.2 Create AssayCreate Assay accessed via the Tests Menu selection on the LuMatic™

Manager Menu Bar:

OPTIONS DESCRIPTION

Assay Name Enter the name of the assay ( A)

Select an AssayMode

Select an Assay Mode from the drop down window

(B)

Calibration But ton Press the Calibration button (C) to continue to the

next window to enter the standard properties.

A B

C





Create Assay (Continued)

Select Standards: Click on the Properties button to enter the standard’s

concentration for curve calculation (D), and then press the OK button.

Select Blanks: Click on the Properties button to enter the RLU range, selectthe action to take when result is out of range from the dropdown menu(choices are Issue Warning or Invalidate Tests), enter a minimum number touse, and then press the OK button.

D

E





Create Assay (Continued)

For Positive/Negative Interpretation results click on the Positive/Negative

button (H):

Click on the Save Assay button (I).

Use Print Preview (J) to view, and Print (K) to obtain a printout of the assaycreated.

5.2.2.3 Edit AssayEdit Assay is accessed via the Tests Menu selection on the LuMatic™Manager Menu Bar:

Select the Assay from the drop down menu. Dialog window will open withoptions based on the assay type.

H

IJ K



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5.2.3 Lot # Registration MenuCalibrator (standard) values are set in the Create or Edit an Assay Section andentering lot numbers for them is optional. See steps below:

Figure 5.2.3-1 Choose the corresponding name

STEPS DESCRIPTION

1 Click on Lot # Registration from the Management Menu.

2 Identify the Substance to be registered by clicking on thesubstance title from the dropdown menu.

3 Click “Register”

4 Enter the lot number and a description (optional). Click OK toSave.

Figure 5.2.3-2 Enter Lo t # and optional description





5.2.4 QC Tracking Menu QC Tracking enables Controls and Calibrators to be tracked using a Levy-Jennings chart.

Figure 5.2.4-1 QC Tracking Menu Page

Figure 5.2.4-2 QC Tracking Example



Monobind LuMatic™


QC Tracking (Continued)

Feature / Description: Steps:

Search by Assay or Name. 1

Choose an Assay, choose a name, or choose a Lot # from thedrop down menus.

2

Edit QC points by clicking on an item in the list and highlightingit.

3

The curve may be viewed by RLU or Concentration results. 4

Data can be printed from this screen by pressing the Print QCReport button. NOTE: Lot numbers are entered in the tab labeledLot # Registration.

5

Edit by selecting the Select QC Points button or by un-checkingthe checkbox for specific QC points.

6

Select the Save QC Points button to save the QC pointsdisplayed.

7





5.2.5 Sample DatabaseSelect Sample DB from the LuMatic™ Manager Menu Bar:

When first opened, the Sample Database window will not have any records todisplay:

5.2.5.1 Add to Sample DatabaseSelect the Edit button to enter Sample ID, Family Name, Given Name, etc. Thiswill be helpful as search criteria when searching the database. Press the Donebutton when finished.

Click onthe Editbutton toenter data.The Editbutton willtoggle toDone.

Click onthe Donebuttonwhen

finishedenteringdata.



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An instructional dialog box will open.

Navigate through the fields on the screen by using the Tab or arrow keyson the keyboard.

Create a Sample ID by typing in the Sample ID field.

Modify a Sample ID record by clicking on the field to edit and typing.

Delete a Sample ID by highlighting the record to delete and press theDelete key on the keyboard.

Additional criterion includes Custom1 or Custom2. Information that can be usefulin either Custom1 or Custom2 can include, but is not limited to, medical issuer,study ID numbers, or chronic diagnosis.





5.2.5.2 Modify Sample IDSelect Edit to edit an existing patient’s information, create a new one or deleteone.

Modify the information and then press the Done button to save the changes.

5.2.5.3 Delete Sample IDHighlight the items to be deleted then press the Delete key on the keyboard.NOTE: The user must be in EDIT mode to be able to delete. A dialog box will

open prompting the user to confirm the deletion of the record. Press Yes todelete, press No to cancel the deletion process.



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5.2.5.4 View Log

Select the View Log button to view the Patient.DB.log in Notepad.

Figure 5.2.5.4-1 View Log button

The log will display the modification date, time and the change that was made:

Figure 5.2.5.4-2 Modified date and time





5.2.5.5 Import Patient Record

Import Patient Record

1) Click to highlight the Sample ID to import. Select the Import button to migrate

the selected record to a text file in Notepad.



Monobind LuMatic™


5.2.5.6 Export Patient Record

Export Patient Record

1) Click to highlight the Sample ID to export. Select the Export button to send the

selected record to the Patient DB.log in Notepad.

2) Click on File and select Save. Close the window when finished.

5.2.5.7 Search Patient Record

Search Patient Record

1) Enter criteria into Search Database area, press OK. All records containing the specifiedcriteria will display.

Searchresult

displayed





5.2.5.8 Choose Patient Record

Choose Patient Record

1) Select the Choose button to add a selected patient to the Sample ID list in the Sample tab.



Monobind LuMatic™


5.2.6 SettingsThe Settings tab provides the user control over certain settings that pertain toStartup, Sample Database, Report Appearance, Report Output, Software,Custom Report and Select Language settings.

Refer to the Sample Report that follows for an example of the custom reports thatmay be generated.

Language selections are English, Spanish and Chinese.

5.2.6.1 Comm Port, Database, Report Settings

OPTION DESCRIPTION

Comm Port, Database,Report…:

Refer to the steps in Section 6.2 COM Port Settings toview / adjust the COM Port Setting of the computer and

the LuMatic™ Model 4401 CLIA Microplate Reader.





5.2.6.1.1 Software Settings

5.2.6.1.1.1 Start up

OPTION DESCRIPTION

Startup Allows the user to adjust settings such that numerical IDand sample ID records will be retained for a specifiedamount of time; and adjust the COM Port setting tomatch the COM Port setting of the computer.

Refer to Section 6.2COM Port Settings



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5.2.6.1.1.2 Sample Database Settings

OPTION DESCRIPTION

Sample Database Allows the user to customize the field names used in thesample database. Click on the checkbox to uncheck the

selection; only selections that are checked boxes will beapplied. Click the OK button once all the selections havebeen made.





5.2.6.1.1.3 Report Appearance

OPTION DESCRIPTION

NOTE: Refer to Figure A fora logo example and reportsample.

Report Appearance allows the user to specify theirpreferences such as margins, page orientation, logo, font etc.

Figure A - Logo Example and Report



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5.2.6.1.1.4 Report Output

OPTION DESCRIPTION

Report Output Report Output allows the user to specify data to print for

different report types.





5.2.6.2 Custom Report Settings

OPTION DESCRIPTION

Custom Report…

Two types of Custom

Report Templates areavailable:

A) Result reporttemplates which arefor custom reports thathave been sorted byrequest time, sorted by

name/ID, or sorted byassay.

B) Assay specificcalibration templatesallow the user toproduce a report fromthe data of a specificassay.

The Custom Report Template screen allows users tochoose a report template for each type of report they

desire to run.Choose the type of report to run and click on the SetTemplate button. The report will be formatted according tothe chosen template until the Custom Report template hasbeen cleared by clicking on the Clear button.

Custom Report…

Click on the Set Templatebutton to select a CustomReport template. Previewcalibration reports via theCalibration Tab andpreview button; previewsample reports via theReport Tab and preview

button. Modify theexample Custom Reportand save it to a new filename.



Monobind LuMatic™


5.2.6.2.1 Custom Report Sample

Figure 5.2.6.2-1 Custom Report Sample





5.2.6.3 Select LanguageTo change the language setting from the default, choose Select Languageunder the Settings menu.

A list of the available language choices will display. After selecting a language, itwill be necessary to close the Manager and restart the software to initialize theselected language.

The selected language will remain in effect until another language is selectedand the software is restarted as in the step above.



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5.2.7 Maintenance The Maintenance option allows the user to update the firmware via the

LuMatic™ Firmware Update selection; and lock / unlock calibration via the

LuMatic™ Calibration Lock/Unlock option.

5.2.7.1 Firmware UpdateThe Firmware Update option allows the user to update to a new firmwareversion. Access to this option is password protected. Contact technical supportfor the password.

Once the correct password is entered the Firmware Update window will openenabling the user to browse the list of files. Technical support will advise whichfile to select. The progress of the update is displayed in the Update Progressfield.

NOTE: The instrument will reboot itself after the firmware update is complete.

Figure 5.2.7.1-1 Firmware Update





5.2.7.2 LuMatic™ Calibration Lock/UnlockThe calibration settings for the LuMatic™ Model 4401 CLIA Microplate Reader

are set by the factory. The LuMatic™ Calibration Lock/Unlock feature is lockedat the factory as well. This feature is for emergency use only by authorizedpersonnel in case the device would need to be recalibrated. Contact technicalsupport for direction.



Monobind LuMatic™


5.2.8 Securi ty Menu Options

The LuMatic™ can be set up with or without a password security system. When theEnabled option is checked (default), the password protection and security restrictionsare enforced.

To remove the password security system so that a login ID is no longer

required, go to the “Security” menu (view Figure 4.1.5-1) and uncheck‘Enabled’.

Clicking on the ‘Enabled’ option disables the security option and the user isprompted:

With ‘Enabled’ checked, the security system is ON. Only Administrators haveaccess to this option.

Figure 5.2.8-1 Security Menu Options

Login as Different User displays the Login screen and allows user to loginwith a different name and password.





Security Menu Options (Continued)

Logout logs current user out of the system, prompts user first:

Create New User creates a new user with ID, password, and security level.The Administrator and Manager(s) may create users.

The software confirms with ‘user has been added’ window.

Remove User The Administrator and Manager(s) may remove users.Highlight the user to delete and press OK.



Monobind LuMatic™


Security Menu Options (Continued)

Warning dialog prompts before removing user:

Change Password All security levels may use this feature. Enter the oldpassword followed by the new password, and confirm new password.

Who is logged in Security access window appears to show who is logged inand their access level (view Figure 5.2.8-2).

Figure 5.2.8-2 Security Access w indow

View Log File opens a log of every user name that has logged on, includinga time and date stamp and a running count of entries.





5.2.9 Help

The Help option provides a dialog window that displays the version of LuMatic™and the version of firmware that is currently installed.



Monobind LuMatic™


5.3 LuMatic™ Manager Tabs

The LuMatic™ Manager Tabs are located at the bottom of the screen:

Tab Title: Descr iption: Item No.:

Plate Layout Tab Plate Layout is the LuMatic™ defaultwindow. Refer to Section 5.3.1.

1

AssayCalibration Tab

Refer to Section 5.3.2 2

Add Samples Tab Refer to Section 5.3.3 3

Test Results Tab Refer to Section 5.3.4 4

Report Tab Refer to Section 5.3.5 5

The list above is the order in which the tabs appear on the menu. In practice, theorder the tabs will be used / repeated are:

Assay Calibration Tab

Add Samples Tab

Plate Layout Tab

Assay Calibration Tab

Test Results

Report Tab

1 2 3 4 5





5.3.1 Plate Layout TabPlate Layout is the LuMatic™ default window and displays when the program isstarted.

Figure 5.3.1-1 Plate Layou t Tab

This window displays the current status of the instrument. Also shown is the currentlyloaded plate.

Feature: Description: Item No.:

Auto Assign Auto Assign allows the user to select 8-way or 12-way trays. This setting will remain in force untilchanged.

1

Tray In /Tray Out

Tray In / Tray Out buttons are provided to allowthe user to manipulate the instrument door to theOpen or Closed position.

2

Load Plate /Save Plate

Load Plate sets up a previously stored assay andSave Plate allows saving a set up assay for futureuse.

3

Plate Location of 96 wells 4Well

AssignmentDisplays area for the position of blanks, thestandard, blank, control(s), Sample ID, and nameof the Assay.

5

1

2

45

3 87

6



Monobind LuMatic™


Plate Layout Tab (Continued)


Reset Clears the layout. 6

Re-Assign Provides the ability to change location of the wells

on the plate.

7

Remove Removes well assignments. 8





5.3.2 Assay Calibration

Assay Calibration Tab features are described in the table below.

Figure 5.3.2-1 Assay Calibrati on Tab

Feature: Descrip tion: ItemNo.:

Choose Assay

Use the drop-down menu ( A) to choose one of the assaysfrom the list.

1

12

3

8

5 4 6

7

A



Monobind LuMatic™


Assay Calibration Tab (Continued)


Add CalibrationTest Information

Selections –

• Select the Curve option to run a new curve, insertsa blank and a calibrator for the assay into the worklist. Select multiple times to add more copies ofeach. This button is not active if the user is runningan assay that does not require calibrators.

•

The 2PT Calibration option is available in Point toPoint (Monobind AccuLite® tests) and Regression

modes and may be used to adjust storedcalibration curves. Once a calibration curve is runfor an assay the user can run a 2-point calibrationwhich will run the second and the next to the lastcalibrators of the calibration curve. The RLUs ofthese calibrators will be compared to their values inthe stored calibration curve. The sampleconcentration values of the samples run with the 2-point calibration will be calculated based on thedegree of luminescence change detected in thestored values of these two calibrators. This allows

the software to compensate for any run-to-runvariability in the assay calibration without having torerun the complete calibration curve. ReferenceSection 4.2.1 Two Point (2PT) Calibration for moreinformation.

• Select the Control option to add all of the Controlsspecified in the assay. Press the button multipletimes to add multiple copies of the controls.

• NOTE: The user may also select calibrators,controls, and blanks individually.

2

Calibration/Controls

List

View the calibration and control results in this area.

Lists the calibrators and controls by name, copiesrequired, and whether or not they are valid.

3







AcceptSelectedButton

To edit the curve, check the curve records (choose part ofcurve records which look good to user), then click the AcceptSelected button.

This button will be enabled if the software determines that theselected points will yield a valid curve.

After activating new curve records, the stored curve ischanged. The software will look at the test list to recalculate allfinished tests of this assay.

4

DiscardNew

The Discard New button allows the user to discard the newlycreated curve and return to the previous curve.

5

PrintPreview Preview calibration and control results before printing statisticssuch as %CV, %Dif, and mean values are also shown. 6

PrintReport

Allows the user to print the selected assay. 7

CurveButton

Toggles between substances selected (calibrators, controls)and calibration curves.

• New Curve Based on Selected Records: - The new curve isbased upon the calibrators selected in the Calibration/Controls List. Select calibrators by clicking on the box to theleft of the calibrator name.

• Stored Curve - When the desired calibrators have beenselected, click on the Accept Selected button to accept.The stored curve is displayed in the window. The storedcurve will then be used for sample calculations.

8



Monobind LuMatic™



In the Assay Calibration tab, add the New Curve and New Control to the Work List byselecting the corresponding option from the drop-down menu (1). In the exampleshown below (Figure 5.3.2-2), [ALL] has been selected. All programmed Calibratorsand Controls will be added to the Work List. You may run more than one of each of

the calibrators.Change the repetition numbers by using menu options (2). The allowable replicatesare from 1 to 96.

Figure 5.3.2-2 Worklist displayed

Select Curve from the drop-down menu. Press the New Curve button once for eachblank and calibrator you intend to run. Select Controls to add controls.

Press Add to Plate (3); the Plate Layout tab will open. Once the correct samplelayout is confirmed, click on the Read plate button to read the plate.

A new assay with a correct valid curve is automatically accepted. The option tochange the curve is available. If the curve is invalid, it will need to be selected andthen accepted before it can be used to calculate sample concentrations. Click on the

Accept button to accept results.

When LuMatic™ is finished reading, the New Assay Calibration Data may be viewedby selecting this option from the Management drop down menu or by pressing the F8key on your keyboard at any time. This window shows whether the new curves andcontrols were accepted. If the curve is not accepted, this procedure must berepeated.

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Accepting calibrators moves them from the LuMatic™ Manager Test Results Tab tothe Assay Calibration Tab.

Once the calibrators have been moved into the Assay Calibration Tab they need to

be accepted. However, selecting the calibration does not make the calibration graphvisible. Select the assay from the drop down list and then click on the graph icon (1)and the calibration curve will display on the right hand side of the screen (2).

Figure 5.3.2-3 Standard Curve Example

The stored curve which is active is displayed on the bottom of the screen. This maybe the previously stored curve or a newly accepted curve. Before the curve isaccepted it can be reviewed for any adverse outlying calibrators. If the outlyingvalues are seen for any of the calibrators, these may be removed by unchecking thecheck box next to this calibrator.

The resulting calibration curve is shown in the upper graph. Once you are satisfiedwith the calibration curve in the upper graph, click the Accept Selected button andthis will move the curve from the upper graph to the lower current graph.

In Figure 5.3.2-3, a standard curve is displayed. This assay uses a 2nd orderpolynomial curve fit. Moving the mouse pointer over the plotted curve will display thefit parameters.

At this point concentration values will be calculated for the samples and displayed inthe Test List Tab.

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Monobind LuMatic™



You can now choose to accept or delete any of the sample results by clicking on thebuttons.

The samples can now be accepted by clicking on the Accept button. The sampleresults will be moved from the Test Results Tab to the Report Tab where they are

automatically stored in the LuMatic™ database and may be printed in reports.

Clicking on the Test Results tab will display the patient results.

5.3.2.1 Adjus ting Curves by a Percentage FactorCurves can also be adjusted by a percentage factor. This is set by the factorsetting in the Calibration tab. This value is normally set to 0%, and the actualstandard curve values are used with no adjustment.

-10% - Factor below the calibration curve is adjusted by -10%. Factoradjustments occur immediately and do not require clicking on the AcceptSelected button.

The new concentration values are displayed in the Add Samples Tab.

The percent adjust feature may be used when stored curves are used and thereis evidence that the current run has resulted in increased or decreased RLUlevels than what is expected.

NOTE: Decreasing the standard curve by a percentage will result in increasingthe sample concentration values.

Less than all of the calibrators used in an assay can be run and the stored curvecan be adjusted accordingly. The adjustment factor will be calculated based onthe average percent change of all the new calibrators run compared to theirstored RLU values. The new curve will be generated from the new calibrator(s)

RLU values which are currently run and the adjusted values of the remainingcalibrators from the stored curve. This feature can be used to control forchanges in activity when using stored curves.

By selecting this standard and all the stored standards the new adjusted curvecan be activated.

Once accepted the original RLU values remain, but the new calculatedconcentration values of the standards are displayed.

Even though the samples show decreased RLU values similar to the oneadjustment standard run, the resulting concentration values for the samples arethe same as when they were run with the original complete standard curve.





5.3.2.2 Using Stored CurvesWhile the stored curve option is available, it is not encouraged by Monobind.Therefore a password is necessary to access the stored curve option for thosefew distributors that request it. The stored curve option should only be used byhighly experienced technicians practicing disciplined testing procedures withminimal run-to-run variance, and must be accompanied by the use of controls.

Reference Section 5.1.1, Password Security, and Section 5.2.8, Security MenuOptions, for information on creating user IDs, passwords, and security levels.

The LuMatic™ software will force a standard curve to be run with Samples if astored curve does not exist. If a valid stored curve exists, the user will have thechoice of running a new curve or performing a 2-point adjustment from the storedcurve.

The LuMatic™ software will allow a user to use a stored curve withoutperforming a 2-point adjustment if the user’s security level is at Manager or

Administrator level. With the proper security level enabled, the software willdisplay the following dialog box when the Read Plate button is pressed andSamples are added to the plate without any calibrators.

If the user is logged in with an Operator security level and no standard curve or2-point adjustment is added with the Samples when the Read Plate button ispressed, the following Login dialog box will display allowing a Manager or the

Administrator to log in.



Monobind LuMatic™


Using Stored Curves (Continued)

If the user logs in as Operator, the message below is displayed and the softwarewill not allow the plate to be read without running a new curve or a 2-point curve.





5.3.3 Add Samples TabThe Add Samples Tab may be used to set up a quick and easy work list. Afterthe Assay is run, return to the Assay Calibration tab to view curve data.

Figure 5.3.3-1 Add Samples Tab


Enter

Sample IDs

Press the ‘Add Sample ID’ to choose a patient

from the Sample Database (refer to Section5.2.5).

Press the ‘Add Numerical ID’ button to entersamples by number.

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Monobind LuMatic™


Add Samples Tab (Cont inued)


ChooseTests

Click on one or more of the numeric/sample ID’son the left to highlight, choose a test to run with

the chosen IDs. Click on the test and press ‘AddTest’.

2

Work List The Work List area of the screen lists the IDs andassays assigned to each, and the number ofrequested copies (Reps).

To add more copies to a test, highlight that rowand use the hidden pull down to change thenumber and click on Add to Plate.

3

If the Add to Plate button has been selected, the screen will be directed to PlateLayout where you will have several options: Load Plate, Save Plate, Reset, Re-

Assign, Read Plate or Remove.





5.3.4 Test Results TabFeatures of the Test Results Tab are described in the table below.

Figure 5.3.4-1 Test Resul ts Tab


Layout Area

Indicates the location of patient samples,reagents, and pertinent assays. For more

information on a particular substance, highlightit with the mouse cursor. For example:

1

List Use the ‘Highlight by Name/ID’ drop down menuto highlight a patient, or use ‘Highlight by Assay’drop down menu to highlight by type of assay. Alist of all of the assays will display. The CurrentStep that is running displays to the right of thedrop down menus.

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5.3.5 Report TabBy default, the Report Tab shows the information from the most recent test run.However, by clicking on the History checkbox (1) it is possible to search by date,Name/ID or test name and display those test results.

Results may be sorted by Request Time, Name/ID, Test, or Interpretation (2).


HistoryCheckbox

Select the History checkbox to begin searchingfor results by date, Name/ID or test name.

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SortingOption

Select the Sorting Option from the drop downmenu to change the way the results aredisplayed.

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Monobind LuMatic™


Report Tab (Continued)


Search byDate

Use the drop down menus to select the dates tosearch for results.

1

ByName/ID

Search for results for a specific Patient. 2

By Test Use this menu to search for results from aspecific assay.

3

Select All Check this box to select all of the results. Onlythe selected results will appear in printouts.

4

Note: If needed, an Assay Report or a Calibration Report may be printed from theCalibration window. See the Section Assay Calibration Tab for more information.

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Report Tab (Continued)


Fold All Fold All narrows the display down to the selection madein the Sorting Options. For example, after sorting byName/ID, click on the Fold All checkbox. The screen

displays only the Name/ID column:

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Print

Preview

Select the Print Preview button, the report will display

providing an advanced glance of what the output will looklike:

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Print Selecting the Print button will print the selected Results inreport format.

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Remove Selecting the Remove button will remove all selecteditems from the results display.

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Retest

(add toSampleTab)

Adds the selected items to the Sample Tab to be re-

tested.

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Export Exports selected results to a text file (*.txt), MS Excel file(*.xls), or XML file (*.xml). Save for future reference.

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Monobind LuMatic™


6. TROUBLESHOOTING

6.1 Error Messages

Explanation of Error Messages generated by the communications programming of

the LuMatic™ instrument:

Error Code(s)/Problem: Solution:

001 Invalid Command

003 Invalid Row Number,%d

004 Invalid Device Number,%d

Check command for spelling and validity.

Row number must be in valid range (1-12)

Device number must be in valid range (0-3), contactCustomer Service

005 Invalid wiper value, %d

006 Invalid Cal Value, %d

007 Invalid Offset Value, %d

008 Invalid Gain Value, %d

Wiper number must be in valid range (0-3), contactCustomer Service

Value must be in valid range (20-110), contactCustomer Service

Offset value must be in valid range (5-250) contactCustomer Service

Gain value must be in valid range (5-250) contactCustomer Service

009 Invalid Number ofSteps, %d

010 Invalid Code

012 Invalid Serial ID

Number of steps must be in valid range (0-1200)

Invalid code entered

Serial ID must be number (1-99999)

102 Calibration DataChecksum Failure

103 EEPROM notacknowledging

Internal checksum doesn’t match, contact customerservice

EEPROM didn’t acknowledge command, contactcustomer service

201 Extra movement of(%d) needed at home

Check that microplate is seated properly in the platecarrier. If using removable strips (8 or 12 well) check

that they are seated properly in the microplate.

211 Extra steps needed in Xdirection

Check that X motor is not jammed

212 X Mover Jammed.Position of Jam: -734,Destination Req: -854

Check motor and shuttle travel for debris, tightness inrotation or encoder not turning. Repeat test without aplate to determine if the plate is causing the skid plateto stall the motor.





Error Messages (Continued)


301 Pot %d, wiper %d,Setting %d returned%d (not 24)

302 Pot %d, wiper %d – notack

303 Pot %d, wiper %d – notack

Contact Customer Service



411 Offset search error Background error. Record the difference between theRead Value and the Target Value. If Read Value is 0then there is a fault in the light conversion and readcircuits. If Read Value is higher than the target valuethen the likely cause is lack of warm-up time or lightleakage into the PMT mounting block. (If the unit hasbeen dismantled in any way, then check thateverything has been correctly re-assembled.)Possible faults: Read Value > Target Value• The unit has not been allowed to fully warm up.• Door is not fully closed.• Main cover is not fitting correctly. Check screws

and fit.• High voltage Cover has not been fitted.• Sealant around the fiber optic to PMT interface

has been disturbed.• Sealant around the PMT to block has been

disturbed.• Fiber is not seated properly at both ends.• The PMT reference LED does not switch off and

gives the same reading for ON Value as OFFValue using the "RDREF()" command. See faultfinding procedure for Error "503 Referenceadjustment out of range".

Read Value = 0• Cable connections may not be correctly seated.

(It is important that all connections are exactlycorrect both destination and orientation). If anycable has been plugged into the wrong socketand the machine has been powered on, some

circuits may have been damaged which will showas multiple faults.

• High Voltage board may not be working (see LEDlamp on board).



Monobind LuMatic™


Error Messages (Continued)


503 Reference adjustmentis out of range

Open the Communications window and look at theread plate results. Check the LumiFactor. If it issignificantly out of range of >1.2 and <0.8, check the

reference LED reading in the same results.Possibly the Reference LED has drifted fromcalibration or is not working at all.

• Ref LED NOT working – If ON Value isapproximately equal to OFF Value i.e. both are<10,000=>LED is not switching ON.

If ON Value is approximately equal to OFF Value andboth are ~200,000=>LED is not switching OFF. If ONValue ~200,000+/-20%, and OFF value is <10,000then Ref LED is working.

• Ref LED drifted – check that the Reference LEDValue against the value when it was calibrated. Ifthis is >+/-10% difference then contact CustomerService.

9001 Cal Page Size >64bytes


9002 Util Page Size >64bytes


9003 Error Page Size >64bytes






6.2 COM Port Settings

Generally the communication (COM) port setting of the PC and the LuMatic™ willnot require adjustment. However, the following steps are included just in case theuser needs to view the setting or make an adjustment to the setting.

6.2.1 PC Communication (COM) Port SettingFollow the steps below to view or adjust the computer’s COM Port Setting.


Click on the STARTbutton on the PC menubar:

Double-Click on the START button on the PC

Click on Contro l Panel

The Control Panelwindow will open up;double-click onSystem



Monobind LuMatic™


PC Communications (COM) Port Setting (Continued)


The System Properties

window will open; clickon the Hardware tab

Click on the DeviceManager button

From the DeviceManager window,

double click on thePorts (COM & LPT)folder.





PC Communications (COM) Port Setting (Continued)


Click on the Ports

(COM & LPT) folder;view the USB-to-SerialComm Port setting.Follow the steps underSection 6.2.2

LuMatic™ Communication (COM)Port Setting to ensurethat the microplatereader’s COM portsetting matches theCOM port setting onyour PC.

NOTE: In this instancethe COM port is COM3,your system maydisplay a different port .

6.2.2 LuMatic™ Communication (COM) Port SettingTo adjust the LuMatic™ COM Port setting to match the computer’s COM Port setting,follow these steps:


Power on the LuMatic™Model 4401 CLIAMicroplate Reader. Theinstrument willannunciate a beepingsound; the LED powerindicator will light (thelight will pulse/flash);and the instrument willwarm-up. When theinstrument hascompleted its

initialization process, itwill annunciate threeshort beeping soundssignaling it isoperational.

The computer screen will display the LuMatic™ logo:



Monobind LuMatic™



LuMatic™ Communication (COM) Port Setting (Continued):

and then the Plate Layout screen will display:

Plate Layout Disp lay

Click on the Settings tab

on the LuMatic™

Manager Menu Bar toaccess the Comm Portsetting:

Click on the “CommPort, Database,Report…” option on theSettings drop downmenu:






The Software Settingswindow will open:

Click on theCommunication Portdrop down menu, andscroll up or down tolocate the COM portsetting that matchesthe COM port settingfrom your PC (seeSection 6.2.1 PCCommunication(COM) Port Setting).

Click to highlight the

setting and then clickon the OK button tosave the setting.

NOTE: The COM portsetting will remain atthis setting until it ischanged.



Monobind LuMatic™


7. CONTACT INFORMATION

If you continue to have problems after consulting your dealer, contact the factory.

Important: When contacting us, please have the Model and Serial Number of the

LuMatic™ Model 4401 CLIA Microplate Reader in question. Have a description of the

problem with as much detail as possible. Save any relevant jobs or logs and send or e-mail us the information.





8. APPENDIX

8.1 Laboratory Information System (LIS)

The LuMatic™ Laboratory Information System (LIS) provides a method, or protocol,to allow for ease of information exchange between two systems. The patient

information from external sources can be easily uploaded into our patient database.This database will contain patient information and tests requested. Upon jobcompletion the patient information and assay results can be downloaded into a textfile following the same protocol. The protocol for data exchange is listed below.

• Import Process:

o Select Management > LIS Import

o Choose a file containing LIS requests.

o Requested tests are added automatically to request list in the Sampletab.

• Export Process:

o In the Report tab, user will select records and press Export button.

o In the Save-As Type drop down list, the user will select LIS files (*.lis).User types in a filename, and a folder, for the file and presses Savebutton.

Record Definitions and Specifications

Record Type Definitions

H| Indicates a Header Record, primarily for informationalpurposes.

P| Indicates a Patient Record and is patient specif ic information.

OBR| Indicates a Requested Assay to be run for the precedingpatient.

OBX| Results from the Requested Assay preceding.

L| Indicates the End of the file.

A| Append this informat ion to the preceding record; may beused on any record.

Figure 8.1-1 Record Type Definitions

manual de operador manual lumatic 4401

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