Manual de Operador Manual Lumatic 4401

Model 4401
OPERATORS MANUAL
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 INSCRIPTIONS DAVERTISSEMENT ...................................................................... 3
1.2.1 Safety Symbols Le Symboles de Sret .......................................................................................... 3
1.2.2 Safety Terms Terminologie de Sret ............................................................................................ 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 UNPACK INSTRUMENT ......................................................................................................................... 10
3.2 PARTS AND CONTROLS ........................................................................................................................ 12
3.2.1 Parts of the Instrument ................................................................................................................ 12
3.3 INSTRUMENT SETUP & SOFTWARE INSTALLATION .............................................................................. 14
3.3.1 Software Installation.................................................................................................................... 14
3.3.2 USB Port Connection .................................................................................................................. 16
3.4 INSTRUMENT 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 INFORMATION SYSTEM (LIS) ....................................................................................... 94
1. INTRODUCTION
1.1 Applications
1.1.1 Intended Use
The LuMatic Model 4401 CLIA Microplate Reader is a laboratory instrument
intended for in-vitro diagnostic use. It is a user-programmable open system with
selectable plate formatting, alphanumeric test naming, automatic interpretation
options, duplicate well options, curve plotting and editing, and flags and error
messages.
The LuMatic Model 4401 CLIA Microplate Reader is a general purpose
instrument intended to be used by trained laboratory professionals who are
capable of selecting the appropriate features and options for each specific clinical
application. Contact your companys instrument service provider to arrange for
training.
WARNING! FOR IN-VITRO DIAGNOSTIC USE

AVERTISSEMENT! POUR L'USAGE DIAGNOSTIQUE IN VITRO
1.1.2 Summary of the Instrument
The LuMatic Model 4401 CLIA Microplate Reader is a plate
chemiluminescence analyzer optimized for Monobinds AccuLite reagent line
and an excellent plug-in for Monobinds AutoPlex Automated ELISA and CLIA
Analyzer. LuMatic software allows the operator to create, edit and store
assays. Standard curves are also stored in this memory. Test protocols remain
stored 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+ test
menu. Raw data RLU readings and calculation modes such as single point
calibration, point-to-point curve fit, multipoints, polynomial regression, linear
regression (log & linear), cubic spline and cutoff modes are offered. The basic
calculations are permanently stored in memory and include several single and
multi-point equations. Each calculation mode is described in detail in Section
4.2-Assay Modes. Provisions are made in certain cases for reading specimens
in duplicate and/or using the mean reading in calculations.
The LuMatic Model 4401 CLIA Microplate Reader reads a 96-well microplate
and calculates results instantly and automatically; and it accepts all standard
microplates. 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.
Monobind LuMatic Model 4401 Operators Manual Rev. A
The LuMatic Model 4401 CLIA Microplate Reader is a user-friendly instrument

certified by Monobind to ensure the optimal performance of AccuLite reagents
giving users the very best in CLIA testing. Built-in references further maintain
peak 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, reporting
and data storage. It is based on the same software as Monobinds 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 Operation

The plate carrier precisely positions each well to be read by the fiber optic. Light
energy is then collected from the sample through a fiber optic cable. The light is
directed to a photomultiplier (PMT). The PMT converts the transmitted light
energy into an amplified electrical signal, which can be interpreted by comparison
with signals from known concentrations.
Upon entering a Test Mode, calibration is checked to an internal LED to ensure
consistent equipment calibration.
1.2 Warning Markings Inscriptions davertissement

1.2.1 Safety Symbols Le Symboles de Sret
Symbols that may appear on the product:
Les symboles de sret peuvent apparaitre sur le produit:
WARNING
AVERTISSEMENT
Protective Ground
La Terre Electrique
CAUTION
LATTENTION
Risk of Shock
Risque de Choc
(Earth) Terminal
Prise de Terre
Refer to Manual
Se Rapportent
a Manuel
BIOHAZARD
BIOHAZARD
Risk of Infection
Risque dinfection
FUSE: For continued protection against risk of fire, replace fuse only with one of
the specified type and current ratings. Disconnect equipment from power supply
before replacing fuse.
FUSIBLE: Pour la protection continue contre le risque du feu, remplacez le
fusible seulement par une du type spcifique et des estimations courantes.
Dmontez lquipement de lalimentation dnergie avant de remplacer le fusible.
1.2.2 Safety Terms Terminologie de Sret

These terms may appear on the product:
Les marques sur le produit:
DANGER
indicates an injury immediately

accessible as you read this marking
DANGER Le de marque:
DANGER
indique le risque immdiat de dommages

(assessible tandis que vous lisez la
marque)
WARNING
indicates an injury hazard not

immediately accessible as you read this
marking
AVERTISSEMENT! Le de
marque: WARNING
indique quun risque de dommages qui

nest pas immdiat alors vous lisent cette
marque
CAUTION
indicates a hazard to property, including

the product
LATTENTION Le de
marque: CAUTION
indique un risque a la proprit

comprenant ce produit
These terms may appear in this manual:

Les marques dans loprateur manuel:
WARNING
WARNING statements identify conditions

or practices that could result in injury or
loss of life. WARNING indicates an injury
hazard not immediately accessible as you
read this marking.
AVERTISSEMENT! Le de
marque: WARNING
Ces rapports identifient les conditions ou

les pratiques qui pourraient avoir comme
consquence les dommages ou les
pertes humaines.
CAUTION
CAUTION statements identify conditions

or practices that could result in damage
to this product or other property.
LATTENTION Le de
marque: CAUTION
Ces rapports identifient les conditions ou

les pratiques qui pourraient avoir comme
consquence les dommages a ce produit
ou a toute autre proprit.
1.3 Safety Precautions

To assure operator safety and prolong the life of your instrument, carefully follow all
instructions outlined below.
Read Instructions Please take the time to read this manual carefully before using
this instrument. Review the following safety precautions to avoid injury and prevent
damage to this instrument or any products connected to it. To avoid potential
hazards, use this instrument only as specified. For best results, familiarize yourself
with 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 servicing
to qualified service personnel. Use only factory-authorized parts. Failure to do so
may void the warranty.
Wear Protective Apparel Many diagnostic assays utilize materials that are potential
biohazards. Always wear protective apparel and eye protection while using this
instrument.
Follow Operating Instructions Do not use this instrument in a manner not specified
by 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 and
certified for the country of use.
Ground the Product This product is grounded through the grounding conductor of
the power cord. To avoid electric shock, the grounding conductor must be connected
to earth ground. An optional method is to attach a ground strap from the external
grounding terminal on the rear panel of the instrument to a suitable ground such as a
grounded pipe or some metal surface to earth ground.
Warning!
Avertissement!
Warning! To avoid electric shock, the grounding conductor in
the supply cord must be connected to earth ground. An
optional method is to attach a ground strap from the external
grounding terminal on the rear panel of the instrument to a
suitable ground such as a grounded pipe or some metal
surface to earth ground.
Avertissement! Pour viter la dcharge lectrique, vous devez
employer la corde de principal courant avec la terre lectrique
(prise de terre). Vous pouvez attacher un bus de masse du
terminal a terre externe sur le panneau arrire de linstrument
dans une pipe fonde des eaux.
Observe All Terminal Ratings To avoid fire or shock hazard, observe all ratings
and markings on the instrument. Consult this manual for further ratings information
before making connections to the instrument.
Install as Directed Install the instrument on a sturdy, level surface capable of

safely supporting the instruments weight 12.5 lbs (5.657 kg). The mounting surface
should be free of vibrations. The instrument does not require fastening to the bench
top.
Provide Proper Ventilation Refer to the installation instructions for details on

installing the product so it has proper ventilation. Provide a minimum 3 inch
clearance (8cm) at the back of the instrument.
Do Not Operate Without Protective Covers Do not operate this instrument with
covers and panels removed.
Use Proper Fuse Use only the fuse type and rating specified by the manufacturer for
this instrument.
Avoid Exposed Circuitry Do not touch exposed connections and components when
power 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 this
instrument, have it inspected by a qualified service person.
Do Not Operate in Wet/Damp Conditions
Do Not Operate In An Explosive Atmosphere
Keep Instrument Surfaces Clean and Dry Solvents such as acetone or thinner will
damage 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. If
needed, a mild all-purpose or nonabrasive cleaner may be used. Use as a
disinfectant a 10% solution of chlorine bleach (5.25% Sodium Hypochlorite) or 70%
isopropyl alcohol. Take special care not to spill liquid inside the instrument.
1.4 Operating Precautions

NOTE: Insufficient RAM will adversely affect the performance of your instrument. For
Microsoft 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 within
their 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 should
be treated as potentially biohazardous. Appropriate cleanup and
disposal of biohazardous waste should be used.
Avertissement! Lors du fonctionnement, si on renverse des
matriaux, coupez immdiatement le courant. Placez le
commutateur lectrique a AU LOIN(0). Traitez le matriel
comme biohazardous, utilisant approprie nettoient et des
mthodes de disposition.
1.4.1 Instrument Warm Up Time

It is advisable that the LuMatic Model 4401 CLIA Microplate Reader be turned
on for a 30 minute warm up before use. This gives the instrument time to warm
up 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 lab
records 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 the
country 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
Software:
PC interface with LuMatic Manager software included (PC not included)
Features:
PC interface software (included) with

complete user prompting, error messages, full
plate 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 (2nd, 3rd, and 4th
order), Linear Regression (log & linear), Dose
Response, Cubic Spline, Cutoff modes
Additional Features:
User-programmable open system, selectable

plate formatting, reporting
QC options:
Store control data, print Levey-Jennings or

QC range plots, calculate SDs
USB port:
USB cable provided
Physical
Enclosure:
Dimensions:
All metal enclosure

7.5 x 8.0 x 16.5
(19x20.3x42cm)
Weight: 12.5 lbs (5.7 kg)
Environmental
Operating Temperature:
Humidity:
15 to 35 C
Between 10 and 85% non-condensing
Storage Temperature:
10 to 50 C
Altitude:
2000m maximum
Design and instrument specifications are subject to change without notice.
3. INSTALLATION
3.1 Unpack Instrument
Carefully unpack the instrument, removing it from its plastic bag. Report any damage
to your freight carrier at once. The box will also contain the Operators 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 the
instrument is shipped to another location or returned for service.
Unpacking Checklist
Quantity
Description
Customer copy of packing list
Unpacking instructions sheet
Certificate of Conformity
Certificate of Quality
Instrument Set Up and Operators Manual
Power cord
USB cable
USB mass storage device
Instrument Mounting and Use

Place the instrument on a flat working surface capable of safely supporting the
instruments weight of 12.5 lbs (5.7 kg). Excessive vibration during reading may
cause poor repeatability; thus, a sturdy working surface is required. A minimum of at
least 3 inches (8cm) clearance around the instrument is required to assure optimal
ventilation.
Power Switch Position
When installing the power cord the unit should be turned off. Look at the rear panel
of the instrument to check that the power switch is in the OFF position. A diagram of
the rear panel can be found in the Section Parts and Controls.
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 a
minimum 18 AWG, Type SVT or SJT three conductor cord, maximum 3 meters (10
feet) in length, rated 10 A, 125 V, with a parallel blade, grounding type attachment
plug.
For 220-240 V units used inside the US use a UL listed cord as above, except rated
250 V, with a tandem blade, grounding type attachment plug. The cord set provided
by the manufacturer meets these requirements.
10
Safety Grounding
Do not alter or defeat the safety grounding methods provided. To avoid the risk of
electric shock, the third prong of the AC power plug must be connected to conductive
parts internal to the equipment. Internal fasteners to grounding points are marked by
. DO NOT loosen or remove these fasteners or
the IEC 417 symbol 5019
connections. An alternate method of grounding is provided by connecting the
grounding terminal located on the rear panel, to a suitable ground.
To avoid electric shock, the power cord protection ground conductor must be
connected to ground.
Assure Clean Power Availability
The circuit used should be substantially free of large voltage transients (Kilovolt amp
loads) such as large pumps, large centrifuges, refrigerators and freezers, air
conditioners, large autoclaves, ovens, and dryers. The instrument may fail to operate
normally if the power supply is interrupted. If this occurs, turn the instrument off for a
moment. When the instrument is turned back on, it will resume normal operation, but
a 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 number
1 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 number
2 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 equipment
requiring service by qualified personnel.
Warning!
Avertissement!
FUSE
Warning! For continued protection against risk of fire, use

the correct fuse. Disconnect power cord from mains supply
before replacing fuses.
FUSIBLE
Avertissement! Pour la protection continue contre le risque

du feu, remplacez le fusible seulement par une du type
spcifique et des estimations courantes. Dmontez
lquipement de lalimentation dnergie avant de
remplacer le fusible.
11
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 the
operation of each feature are provided in Section 4-Operating Procedures.
3.2.1 Parts of the Instrument
A) Door
B) Indicator
light
Figure 3.2.1-1 Front of Instrument
A) Tray out
(extended)
B) Indicator
light
C) Door open
B
C
Figure 3.2.1-2 Door open, tray out
12
A) Power switch
B) Power cord
connection
C) USB
Connection
A
B
Figure 3.2.1-3 Back of Instrument
13
3.3 Instrument Setup & Software Installation

IMPORTANT NOTE:
AS WITH MANY USB DEVICES IT IS CRITICAL THAT YOU DO NOT CONNECT THE
USB CABLE TO THE LUMATIC OR COMPUTER UNTIL THE SOFTWARE HAS
BEEN 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 3.3.2
for USB port connectivity.
3.3.1 Software Installation

Turn on the computer and insert the Compact Disk (CD) supplied with the instrument
into the computers CD drive. Double-click on the setup.exe to begin Setup
installation. Follow the prompts for installing the program and the communications
port drivers.
Steps
Prompts/Screen Display
Double-click on
setup.exe to begin
Setup
Figure 3.3.1-1 Double-Click to Begin Setup
14
Steps
Setup process begins with the Welcome screen:
And then the opportunity to select the destination folder default or choose another folder:
LuMatic Manager
Icon
15
The PC COM port setting does not require an adjustment before activating
LuMatic Manager. However, instructions on how to view and adjust the setting are
provided in Section 6.2.1 PC Communication (COM) Port Setting.
The LuMatic COM port setting does not require an adjustment to match the
computers COM Port setting. However, steps have been provided in Section 6.2.2
LuMatic Communication (COM) Port Setting to view/adjust the setting if
necessary.
3.3.2 USB Port Connection

Using the USB cable provided, connect the computers USB port to the LuMatic
USB port (reference Figure 3.3.2-1 Back of Instrument).
Connect to the
USB port
connection on the
back of the
Connect to the
computers USB
port
LuMatic
instrument (A)
USB cable
Figure 3.3.2-1 Back of Instrument
16
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 computer
and the LuMatic instrument refer to the instructions found under Section 6.2 - COM
Port 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 short
beeping 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.
17
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 those
questions that pertain to the mode selected will be asked. In the RLU mode, for
example, there are no further selections required.
Review the following questions before beginning a test (refer to the CLIA kit insert for
required 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 are
used interchangeably to designate reference materials of known
concentrations
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 are
used 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 automatic
comparison? 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 which
begins the positive range will be required.
9. Will a cutoff value be used to label negative samples or define an equivocal
zone? If so, results less than what cutoff should be labeled as negative?
18
4.1.1 Selecting a Plate Format

Opaque microplates can be read in either the left/right direction (8 well strips) or
in 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 is

connected via USB cable to your personal
computer (see Section Instrument Setup &
Software Installation) and power up the
instrument.
The instrument will annunciate a beeping
sound; the LED power indicator will light
(the light will pulse/flash); and the
instrument will warm-up.
When the instrument has completed its
initialization process, it will annunciate
three short beeping sounds signaling it is
operational.
Click to
choose
8 way
or
12 way
plate
format:
Click on the LuMatic Manager icon:
The Plate Layout screen will display on the

PC monitor.
The plate format is chosen by clicking on
the 8-way or 12-way buttons. Once a
format is selected, it stays selected until
the user changes it.
Plate
Layout
screen:
19
4.2 Assay Modes

The LuMatic software contains several pre-programmed general-purpose
calculations selected to facilitate data handling for enzyme immunoassays and other
similar tests.
Access the Assay Modes via LuMatic Manager Tests Menu (refer to Section
5.2.2)
20
RLU
Factor
Standard
% RLU
Point to Point
Polynomial Regression (Polynomial 2nd, 3rd, 4th Order)
Linear Regression
Dose Response
Cubic Spline
Cut Off
4.2.1 RLU Mode

RLU Mode
Description:
The LuMatic Model 4401 CLIA Microplate
Reader reads and prints RLUs.
Blanking is optional.
4.2.2 Factor Mode

Factor Mode
Description:
In Factor Mode, the instrument
reads and calculates
concentrations by multiplying
the RLU readings by the user
supplied factor.
21
4.2.3 Standard Mode

Standard Mode
Description:
The instrument first accepts a calibrator
read singly or in multiple numbers and then
calculates concentrations based on a singlepoint standard curve passing through the
point (0,0).
A blank is required to determine the (0,0)
point.
4.2.4 % RLU Mode

% RLU Mode
Description:
This mode is a point-to-point calibration
mode which calculates a % RLU for each
sample and calibrator in addition to a
concentration value.
The highest calibrator is assigned a value
of 100% and each sample and calibrator
is calculated as a percentage of this value
and displayed in the Interpretation field of
the report. This mode does not support ln,
logit or log scales for the RLU axis.
The instrument accepts a number of
calibrators (from 2 to 30) read singly or in
multiple numbers.
Blanking, graphing, and editing options
are available.
22
4.2.5 Point-to-Point Mode

Point to Point Mode
Description:
The instrument accepts a number of
calibrators (from 2 to 30) read singly or in
multiple numbers.
It then calculates concentrations based on
the point-to-point calibration curve.
Data may be entered for linearlinear, ln ( = natural log)-linear,
linear-ln, or ln-ln calculations.
Blanking, graphing, and editing options
are available.
NOTE: Assay axis types are

available under other regression
modes as well.
Assay Axis Types:

Data may be entered for linear-linear,
ln (= natural log)-linear, linear-ln, or lnln calculations. A logit-log calculation is
also available. RLUs, or ln of (1000 *
RLU), is always on the Y axis.
Concentration, or ln of concentration, is
always on the X axis.
1. Y= RLU, X=CONC - both the RLU
data (y) and the concentration data
(x) are linear.
2. Y=Ln (1000*RLU), X=Conc - the
natural log of the RLU reads is
plotted against the concentration.
The values are multiplied by 1000
before taking the logs.
3. Y=RLU, X=Ln(Conc) RLUs reads
areas plotted against the natural log of
the concentration.
4. Y= Ln (1000*RLU), X=Ln(Conc) the natural log of the RLU reads is
plotted against the natural log of the
concentration.
23
Point to Point Mode (Continued)

Point to Point Mode (Continued)
Description:
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 as
part of the curve; it is used only for
the calculations.
6. Y=Log(1000*RLU), X=Conc - the
base-10 log of the RLU read is
plotted against the concentration.
The values are multiplied by 1000
before taking the logs.
7. Y=RLU, X=Log(Conc) reads are
plotted against the base-10 log of the
concentration.
8. Y=Log(1000*RLU), X=Log(Conc) -the base-10 log is plotted against the
base-10 log of the concentration.
In the Linear Regression mode, resulting
concentrations will be the same no
matter what base is used (ln or log).
However, slopes and intercepts will vary.
When using a format which calculates
the ln or log of the concentration, (do not
use 0.0 for the concentration, since ln 0
and log 0 are not defined. If a 0.0
concentration Calibrator is used, it will be
ignored when the regression is
calculated.
Note that in the logarithmic modes, any
values which require the log of a zero or
negative number are invalid, and will
either invalidate the curve (if in the
Calibrators) or invalidate the specimen.
Likewise, when using ln of 1000*RLU,
the RLU values must be nonzero and
positive.
24
4.2.6 Polynomial Regression Mode

Polynomial Regression Mode:
Description:
The instrument accepts a number
of calibrators (from 3 to 30),
subsequently calculating
concentrations based upon the
best fit (polynomial regression)
calibration curve.
These modes use nonlinear
regression to fit the calibration
curve to polynomial equations.
The order of the polynomial
equation tells you how many
terms are in the equation.
Higher order equations have more
inflection 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 are

available.
25
4.2.7 Linear Regression Mode

Linear Regression Mode:
Description:
The instrument accepts a number
of calibrators (from 2 to 30),
subsequently calculating
concentrations based on the best
fit (linear regression).
Data may be entered for linearlinear, ln (= natural log)-linear,
linear-ln, or ln-ln calculations.
A logit-log calculation is also
available.
Blanking, graphing and editing
options are available.
RLUs, or ln of (1000 * RLU), are
always on the Y axis, and
concentration, or ln of
concentration, is always on the
X axis.
26
4.2.8 Dose Response Mode

Dose Response Mode:
Description:
Dose Response mode uses nonlinear regression (LevenbergMarquardt method) to fit the
calibration curve to a fourparameter logistic equation
defined by:
Y = Bottom + (Top-Bottom) / (1 +
10 ^ ((LogEC50-X) * HillSlope))
yielding a sigmoid curve.
The parameter Bottom is the
RLU value at the bottom of the
plateau, Top is the value at the
top of the plateau, and LogEC50
is the concentration value halfway
between the Bottom and Top.
The parameter HillSlope
describes the steepness of the
curve. When the Hillslope is less
than 1.0 the curve is shallower,
when the Hillslope is greater than
1.0 the curve is steeper.
4.2.9 Cubic Spline Mode

Cubic Spline Mode:
Description:
Cubic Spline mode accepts a
number of calibrators and
calculates concentrations based
on the Cubic Spline (Constrained)
calibration curve.
The resulting calibrator curve is a
smooth curve connecting the
calibrator points, which may be
entered in ascending or
descending order of RLU reads. A
constraining algorithm is applied
to prevent curve overshoot.
27
Cubic Spline Mode (Continued)

Cubic Spline Mode (Continued):
Description:
4.2.10 Cutoff Mode

Cutoff Mode:
Description:
A number of negative controls are
read, followed by a number of
positive controls.
Blanking is optional.
COV = X * mean (Nc) + F
Use this equation if only a

negative control is used to
determine the COV.
COV = Y * mean (Pc) +F
Use this equation if only a

positive control is used to
determine the COV.
COV = X*mean (NC) + Y*mean
(Pc) + F
Use this equation when

LuMatic must calculate the
cutoff value based upon
readings or positive and/or
negative controls.
28
Cutoff Mode (Continued)

Cutoff Mode (Continued):
Description:
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 than
the cut off are labeled as positive. If you choose this option, be
careful to follow the < and > signs in the prompts for entering cut offs
and ranges.
In this equation, NC and PC are used to determine the COV (cutoff

value).
Enter the variables provided in the package insert.
LuMatic calculates the mean of the positives and the mean of the
negatives.
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 will
equal 1 if no value of variable provided.
mCC = the calculated mean of the RLU values of the cutoff controls
when test is run
Blanking is optional, dependent upon the assay kit
29
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 positives
and 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 in
which the mean of the highest standard RLU value is normalized to 100,000 RLUs
and all the other standards and samples RLU readings are adjusted by the same
factor. Since a Relative Light Unit (RLU) is not a standardized unit, assay RLU
values can vary greatly when read on different instruments. Standard curve
normalization allows chemiluminescent results read on different luminometers to be
directly compared. The actual measured RLUs for each well are displayed in the
Reading field of the results database while the normalized RLU values are displayed
in the RLU field of the database. See the example below:
RLUs normalized
RLUs actual
Example - RLU values
30
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 the
last thirty days, users may select 2PT calibrators and fit data (patient unknowns) to a
stored curve that is validated and adjusted by two calibrators (the second lowest and
the second highest: i.e. B & E in a six-standard assay or B & F in a seven- standard
assay). Additionally, commercial controls should be included in the run and the
determined values should fall within established ranges.
Figure 1 shows a standard curve (with calibrators labeled A-G) being used to
ascertain the concentration of TSH in unknown specimens:
G
F
D
C
Note: Due to the inherent variability in light and CLIA testing, Monobind does not
recommend the use of stored curves alone.
31
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).
32
Two Point (2PT) Calibration (Continued)

After the run completes, the screen will display the curve (C) and the RLU data of the
two adjustment points. The samples run with the 2 point adjustment will have their
read RLU values adjusted based on the RLU values of the two adjustment points.
Values
of two
adjustment
points
33
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 USB
cable 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
34
5.1.1 Password Security and Logging In
When 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
For Password, type Admin
Admin
Admin
There are three security access levels: Administrator, Manager, and

Operator. View Figure 5.1.1-1 for security levels. Reference Section 5.2.8
Security Menu Options for security settings such as change password, create
new user, etc.
While the Stored Curve Option is available, it is not encouraged by
Monobind. The Stored Curve Option should only be used by highly
experienced technicians practicing disciplined testing procedures with
minimal run-to-run variance, and must be accompanied by the use of
controls. Keep the installation CD in a secure location because the
installation CD may be used to reset the Admin password.
In order to access stored curves, a security password must be established by
the Administrator for the Manager(s). Operator level access does not allow
for access to stored curve. Reference Section 5.3.2.2, Using Stored Curves
and Section 5.2.8, Security Menu Options.
Security Level
Administrator
Manager
Disable Security
Y
N
Enable Security
Y
N
Create Manager
Y
N
Create Operator
Y
Y
Remove Manager
Y
N
Remove Operator
Y
Y
Change Password
Y
Y
View Log File
Y
N
Access stored curve (reference
Y
Y
Use of Stored Curves section)
Figure 5.1.1-1 Security Levels
Operator
N
N
N
N
N
N
Y
N
N
35
5.1.2 LuMatic Manager Toolbar Icons
Figure 5.1.2-1 Toolbar Icons
36
Connect
New Assay Calibration Data
Lot # Registration
QC Tracking
Sample Database
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 for

information explaining the LIS Import Option and examples of import
and export files.
New Assay
Calibration Data
Displays current assay calibration list.
Exit
Click Exit to close the program and a dialog window will display:
37
5.2.2 Tests Menu
5.2.2.1 Read Plate RLUs

Read Plate RLUs is accessed via the Tests Menu selection on the LuMatic
Manager Menu Bar:
OPTION
Use Blank
Click on the check box if Blank is used.
Read Plate
Click on the Read Plate button to activate.
Last Read Well
If an end of read location is desired, indicate well and

row, such as F12. Otherwise, the entire plate is read.
(Empty=Read All)
Export
38
DESCRIPTION
Click on the Export button to send the RLU readings to

Notepad, creating a .txt file:
5.2.2.2 Create Assay

Create 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 Assay
Mode
Select an Assay Mode from the drop down window

(B)
Calibration Button
Press the Calibration button (C) to continue to the

next window to enter the standard properties.
39
Create Assay (Continued)

Select Standards: Click on the Properties button to enter the standards
concentration for curve calculation (D), and then press the OK button.
Select Blanks: Click on the Properties button to enter the RLU range, select
the action to take when result is out of range from the dropdown menu
(choices are Issue Warning or Invalidate Tests), enter a minimum number to
use, and then press the OK button.
40

Select Controls: The controls will be accepted even if they read out of range
if the Control Properties are set to Issue Warning. To check your Control
Properties or change this setting, see the Assay Calibration Tab. Click on the
Interpretation button (F).
Specify range by clicking the Normal/Linear Range button (G) to monitor the
quality (optional). Highlight the field to change, type in new value.
41

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 assay
created.
5.2.2.3 Edit Assay

Edit 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 with
options based on the assay type.
42
5.2.3 Lot # Registration Menu

Calibrator (standard) values are set in the Create or Edit an Assay Section and
entering lot numbers for them is optional. See steps below:
Figure 5.2.3-1 Choose the corresponding name
STEPS
DESCRIPTION
Click on Lot # Registration from the Management Menu.
Identify the Substance to be registered by clicking on the

substance title from the dropdown menu.
Click Register
Enter the lot number and a description (optional). Click OK to

Save.
Figure 5.2.3-2 Enter Lot # and optional description
43
5.2.4 QC Tracking Menu

QC Tracking enables Controls and Calibrators to be tracked using a LevyJennings chart.
Figure 5.2.4-1 QC Tracking Menu Page
Figure 5.2.4-2 QC Tracking Example
44
QC Tracking (Continued)
Feature / Description:
Steps:
Search by Assay or Name.
Choose an Assay, choose a name, or choose a Lot # from the

drop down menus.
Edit QC points by clicking on an item in the list and highlighting

it.
The curve may be viewed by RLU or Concentration results.
Data can be printed from this screen by pressing the Print QC

Report button. NOTE: Lot numbers are entered in the tab labeled
Lot # Registration.
Edit by selecting the Select QC Points button or by un-checking

the checkbox for specific QC points.
Select the Save QC Points button to save the QC points

displayed.
45
5.2.5 Sample Database

Select Sample DB from the LuMatic Manager Menu Bar:
When first opened, the Sample Database window will not have any records to
display:
5.2.5.1 Add to Sample Database

Select the Edit button to enter Sample ID, Family Name, Given Name, etc. This
will be helpful as search criteria when searching the database. Press the Done
button when finished.
Click on
the Edit
button to
enter data.
The Edit
button will
toggle to
Done.
Click on
the Done
button
when
finished
entering
data.
46
An instructional dialog box will open.
Navigate through the fields on the screen by using the Tab or arrow keys
on 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 the

Delete key on the keyboard.
Additional criterion includes Custom1 or Custom2. Information that can be useful

in either Custom1 or Custom2 can include, but is not limited to, medical issuer,
study ID numbers, or chronic diagnosis.
47
5.2.5.2 Modify Sample ID

Select Edit to edit an existing patients information, create a new one or delete
one.
Modify the information and then press the Done button to save the changes.
5.2.5.3 Delete Sample ID

Highlight 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 to
delete, press No to cancel the deletion process.
48
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
49
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.
50
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 specified
criteria will display.
Search
result
displayed
51
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.
52
5.2.6 Settings
The Settings tab provides the user control over certain settings that pertain to
Startup, 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 that
may be generated.
Language selections are English, Spanish and Chinese.
5.2.6.1 Comm Port, Database, Report Settings

OPTION
Comm Port, Database,
Report:
DESCRIPTION
Refer to the steps in Section 6.2 COM Port Settings to
view / adjust the COM Port Setting of the computer and
the LuMatic Model 4401 CLIA Microplate Reader.
53
5.2.6.1.1 Software Settings
5.2.6.1.1.1 Start up
OPTION
Startup
DESCRIPTION
Allows the user to adjust settings such that numerical ID
and sample ID records will be retained for a specified
amount of time; and adjust the COM Port setting to
match the COM Port setting of the computer.
Refer to Section 6.2

COM Port Settings
54
5.2.6.1.1.2 Sample Database Settings

OPTION
Sample Database
DESCRIPTION
Allows the user to customize the field names used in the
sample database. Click on the checkbox to uncheck the
selection; only selections that are checked boxes will be
applied. Click the OK button once all the selections have
been made.
55
5.2.6.1.1.3 Report Appearance

OPTION
DESCRIPTION
Report Appearance allows the user to specify their
preferences such as margins, page orientation, logo, font etc.
NOTE: Refer to Figure A for

a logo example and report
sample.
Figure A - Logo Example and Report
56
5.2.6.1.1.4 Report Output

OPTION
Report Output
DESCRIPTION
Report Output allows the user to specify data to print for
different report types.
57
5.2.6.2 Custom Report Settings

OPTION
Custom Report
Two types of Custom
Report Templates are
available:
DESCRIPTION
The Custom Report Template screen allows users to
choose a report template for each type of report they
desire to run.
Choose the type of report to run and click on the Set
Template button. The report will be formatted according to
the chosen template until the Custom Report template has
been cleared by clicking on the Clear button.
A) Result report
templates which are
for custom reports that
have been sorted by
request time, sorted by
name/ID, or sorted by
assay.
B) Assay specific
calibration templates
allow the user to
produce a report from
the data of a specific
assay.
Custom Report
Click on the Set Template
button to select a Custom
Report template. Preview
calibration reports via the
Calibration Tab and
preview button; preview
sample reports via the
Report Tab and preview
button. Modify the
example Custom Report
and save it to a new file
name.
58
5.2.6.2.1 Custom Report Sample
Figure 5.2.6.2-1 Custom Report Sample
59
5.2.6.3 Select Language

To change the language setting from the default, choose Select Language
under the Settings menu.
A list of the available language choices will display. After selecting a language, it
will be necessary to close the Manager and restart the software to initialize the
selected language.
The selected language will remain in effect until another language is selected
and the software is restarted as in the step above.
60
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 Update

The Firmware Update option allows the user to update to a new firmware
version. Access to this option is password protected. Contact technical support
for the password.
Once the correct password is entered the Firmware Update window will open
enabling the user to browse the list of files. Technical support will advise which
file to select. The progress of the update is displayed in the Update Progress
field.
NOTE: The instrument will reboot itself after the firmware update is complete.
Figure 5.2.7.1-1 Firmware Update
61
5.2.7.2 LuMatic Calibration Lock/Unlock

The calibration settings for the LuMatic Model 4401 CLIA Microplate Reader
are set by the factory. The LuMatic Calibration Lock/Unlock feature is locked
at the factory as well. This feature is for emergency use only by authorized
personnel in case the device would need to be recalibrated. Contact technical
support for direction.
62
5.2.8 Security Menu Options

The LuMatic can be set up with or without a password security system. When the
Enabled option is checked (default), the password protection and security restrictions
are 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 is
prompted:
With Enabled checked, the security system is ON. Only Administrators have
access to this option.
Figure 5.2.8-1 Security Menu Options
Login as Different User displays the Login screen and allows user to login
with a different name and password.
63
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.
64
Remove User The Administrator and Manager(s) may remove users.

Highlight the user to delete and press OK.
Security Menu Options (Continued)

Warning dialog prompts before removing user:
Change Password All security levels may use this feature. Enter the old
password followed by the new password, and confirm new password.
Who is logged in Security access window appears to show who is logged in

and their access level (view Figure 5.2.8-2).
Figure 5.2.8-2 Security Access window
View Log File opens a log of every user name that has logged on, including
a time and date stamp and a running count of entries.
65
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.
66
5.3 LuMatic Manager Tabs

The LuMatic Manager Tabs are located at the bottom of the screen:
Tab Title:
Description:
Item No.:
Plate Layout Tab
Plate Layout is the LuMatic default

window. Refer to Section 5.3.1.
Assay
Calibration Tab
Refer to Section 5.3.2
Add Samples Tab
Test Results Tab
Report Tab
The list above is the order in which the tabs appear on the menu. In practice, the
order the tabs will be used / repeated are:
Assay Calibration Tab
Add Samples Tab
Plate Layout Tab
Assay Calibration Tab
Test Results
Report Tab
67
5.3.1 Plate Layout Tab

Plate Layout is the LuMatic default window and displays when the program is
started.
5
4
1
6
3
Figure 5.3.1-1 Plate Layout Tab
This window displays the current status of the instrument. Also shown is the currently
loaded plate.
68
Feature:
Description:
Item No.:
Auto Assign
Auto Assign allows the user to select 8-way or 12way trays. This setting will remain in force until
changed.
Tray In /
Tray Out
Tray In / Tray Out buttons are provided to allow

the user to manipulate the instrument door to the
Open or Closed position.
Load Plate /
Save Plate
Load Plate sets up a previously stored assay and

Save Plate allows saving a set up assay for future
use.
Plate
Location of 96 wells
Well
Assignment
Displays area for the position of blanks, the

standard, blank, control(s), Sample ID, and name
of the Assay.
Plate Layout Tab (Continued)

Feature:
Description:
Item No.:
Reset
Clears the layout.
Re-Assign
Provides the ability to change location of the wells

on the plate.
Remove
Removes well assignments.
69
5.3.2 Assay Calibration
Assay Calibration Tab features are described in the table below.

1
Figure 5.3.2-1 Assay Calibration Tab
Feature:
Choose
Assay
Description:
Use the drop-down menu (A) to choose one of the assays
from the list.
70
Item
No.:
1
Assay Calibration Tab (Continued)

Feature:
Description:
Add Calibration
Test Information
Item
No.:
2
Selections
Select the Curve option to run a new curve, inserts
a blank and a calibrator for the assay into the work
list. Select multiple times to add more copies of
each. This button is not active if the user is running
an assay that does not require calibrators.
The 2PT Calibration option is available in Point to
Point (Monobind AccuLite tests) and Regression
modes and may be used to adjust stored
calibration curves. Once a calibration curve is run
for an assay the user can run a 2-point calibration
which will run the second and the next to the last
calibrators of the calibration curve. The RLUs of
these calibrators will be compared to their values in
the stored calibration curve. The sample
concentration values of the samples run with the 2point calibration will be calculated based on the
degree of luminescence change detected in the
stored values of these two calibrators. This allows
the software to compensate for any run-to-run
variability in the assay calibration without having to
rerun the complete calibration curve. Reference
Section 4.2.1 Two Point (2PT) Calibration for more
information.
Select the Control option to add all of the Controls
specified in the assay. Press the button multiple
times to add multiple copies of the controls.
NOTE: The user may also select calibrators,
controls, and blanks individually.
Calibration/Controls
List
View the calibration and control results in this area.

Lists the calibrators and controls by name, copies
required, and whether or not they are valid.
71

Feature:
Accept
Selected
Button
Description:
To edit the curve, check the curve records (choose part of
curve records which look good to user), then click the Accept
Selected button.
Item
No.:
4
This button will be enabled if the software determines that the

selected points will yield a valid curve.
After activating new curve records, the stored curve is
changed. The software will look at the test list to recalculate all
finished tests of this assay.
Discard
New
The Discard New button allows the user to discard the newly
created curve and return to the previous curve.
Print
Preview
Preview calibration and control results before printing statistics

such as %CV, %Dif, and mean values are also shown.
Print
Report
Allows the user to print the selected assay.
Curve
Button
Toggles between substances selected (calibrators, controls)

and calibration curves.
New Curve Based on Selected Records: - The new curve is

based upon the calibrators selected in the Calibration/
Controls List. Select calibrators by clicking on the box to the
left of the calibrator name.
Stored Curve - When the desired calibrators have been
selected, click on the Accept Selected button to accept.
The stored curve is displayed in the window. The stored
curve will then be used for sample calculations.
72

In the Assay Calibration tab, add the New Curve and New Control to the Work List by
selecting the corresponding option from the drop-down menu (1). In the example
shown below (Figure 5.3.2-2), [ALL] has been selected. All programmed Calibrators
and 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 replicates
are from 1 to 96.
1
2
Figure 5.3.2-2 Worklist displayed
Select Curve from the drop-down menu. Press the New Curve button once for each
blank 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 sample
layout 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 to
change the curve is available. If the curve is invalid, it will need to be selected and
then 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 viewed
by selecting this option from the Management drop down menu or by pressing the F8
key on your keyboard at any time. This window shows whether the new curves and
controls were accepted. If the curve is not accepted, this procedure must be
repeated.
73

Accepting calibrators moves them from the LuMatic Manager Test Results Tab to
the 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 graph
visible. 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).
1
Figure 5.3.2-3 Standard Curve Example
The stored curve which is active is displayed on the bottom of the screen. This may
be the previously stored curve or a newly accepted curve. Before the curve is
accepted it can be reviewed for any adverse outlying calibrators. If the outlying
values are seen for any of the calibrators, these may be removed by unchecking the
check box next to this calibrator.
The resulting calibration curve is shown in the upper graph. Once you are satisfied
with the calibration curve in the upper graph, click the Accept Selected button and
this 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 order
polynomial curve fit. Moving the mouse pointer over the plotted curve will display the
fit parameters.
At this point concentration values will be calculated for the samples and displayed in
the Test List Tab.
74

You can now choose to accept or delete any of the sample results by clicking on the
buttons.
The samples can now be accepted by clicking on the Accept button. The sample
results 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 Adjusting Curves by a Percentage Factor

Curves can also be adjusted by a percentage factor. This is set by the factor
setting in the Calibration tab. This value is normally set to 0%, and the actual
standard curve values are used with no adjustment.
-10% - Factor below the calibration curve is adjusted by -10%. Factor
adjustments occur immediately and do not require clicking on the Accept
Selected 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 there
is evidence that the current run has resulted in increased or decreased RLU
levels than what is expected.
NOTE: Decreasing the standard curve by a percentage will result in increasing
the sample concentration values.
Less than all of the calibrators used in an assay can be run and the stored curve
can be adjusted accordingly. The adjustment factor will be calculated based on
the average percent change of all the new calibrators run compared to their
stored 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 remaining
calibrators from the stored curve. This feature can be used to control for
changes in activity when using stored curves.
By selecting this standard and all the stored standards the new adjusted curve
can be activated.
Once accepted the original RLU values remain, but the new calculated
concentration values of the standards are displayed.
Even though the samples show decreased RLU values similar to the one
adjustment standard run, the resulting concentration values for the samples are
the same as when they were run with the original complete standard curve.
75
5.3.2.2 Using Stored Curves

While the stored curve option is available, it is not encouraged by Monobind.
Therefore a password is necessary to access the stored curve option for those
few distributors that request it. The stored curve option should only be used by
highly experienced technicians practicing disciplined testing procedures with
minimal 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 Menu
Options, for information on creating user IDs, passwords, and security levels.
The LuMatic software will force a standard curve to be run with Samples if a
stored curve does not exist. If a valid stored curve exists, the user will have the
choice of running a new curve or performing a 2-point adjustment from the stored
curve.
The LuMatic software will allow a user to use a stored curve without
performing a 2-point adjustment if the users security level is at Manager or
Administrator level. With the proper security level enabled, the software will
display the following dialog box when the Read Plate button is pressed and
Samples are added to the plate without any calibrators.
If the user is logged in with an Operator security level and no standard curve or
2-point adjustment is added with the Samples when the Read Plate button is
pressed, the following Login dialog box will display allowing a Manager or the
Administrator to log in.
76
Using Stored Curves (Continued)

If the user logs in as Operator, the message below is displayed and the software
will not allow the plate to be read without running a new curve or a 2-point curve.
77
5.3.3 Add Samples Tab

The Add Samples Tab may be used to set up a quick and easy work list. After
the Assay is run, return to the Assay Calibration tab to view curve data.
3
Figure 5.3.3-1 Add Samples Tab
Feature:
Enter
Sample IDs
Description:
Press the Add Sample ID to choose a patient
from the Sample Database (refer to Section
5.2.5).
Press the Add Numerical ID button to enter
samples by number.
78
Item No.:
1
Add Samples Tab (Continued)

Feature:
Description:
Item No.:
Choose
Tests
Click on one or more of the numeric/sample IDs

on the left to highlight, choose a test to run with
the chosen IDs. Click on the test and press Add
Test.
Work List
The Work List area of the screen lists the IDs and
assays assigned to each, and the number of
requested copies (Reps).
To add more copies to a test, highlight that row

and use the hidden pull down to change the
number and click on Add to Plate.
If the Add to Plate button has been selected, the screen will be directed to Plate
Layout where you will have several options: Load Plate, Save Plate, Reset, ReAssign, Read Plate or Remove.
79
5.3.4 Test Results Tab

Features of the Test Results Tab are described in the table below.
3
4
Figure 5.3.4-1 Test Results Tab
Feature:
80
Description:
Item No.:
Layout
Area
Indicates the location of patient samples,

reagents, and pertinent assays. For more
information on a particular substance, highlight
it with the mouse cursor. For example:
List
Use the Highlight by Name/ID drop down menu

to highlight a patient, or use Highlight by Assay
drop down menu to highlight by type of assay. A
list of all of the assays will display. The Current
Step that is running displays to the right of the
drop down menus.
Test Results Tab (Continued)

Feature:
Description:
Item No.:
Select All
The Select All button selects all of the entries

in the list. Items may also be selected
individually.
Action
buttons
Click Accept to accept the results of the

selected ID.
Press Delete to discard the selected ID.

NOTE: Results must be accepted to allow them
to be viewed in the Report Tab.
81
5.3.5 Report Tab

By 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).
1
Feature:
82
Description:
Item No.:
History
Checkbox
Select the History checkbox to begin searching

for results by date, Name/ID or test name.
Sorting
Option
Select the Sorting Option from the drop down

menu to change the way the results are
displayed.
Report Tab (Continued)
6
4
Feature:
10
Description:
Item No.:
Search by
Date
Use the drop down menus to select the dates to

search for results.
By
Name/ID
Search for results for a specific Patient.
By Test
Use this menu to search for results from a

specific assay.
Select All
Check this box to select all of the results. Only

the selected results will appear in printouts.
Note: If needed, an Assay Report or a Calibration Report may be printed from the
Calibration window. See the Section Assay Calibration Tab for more information.
83
Report Tab (Continued)

Feature:
84
Description:
Item No.:
Fold All
Fold All narrows the display down to the selection made

in the Sorting Options. For example, after sorting by
Name/ID, click on the Fold All checkbox. The screen
displays only the Name/ID column:
Print
Preview
Select the Print Preview button, the report will display

providing an advanced glance of what the output will look
like:
Print
Selecting the Print button will print the selected Results in

report format.
Remove
Selecting the Remove button will remove all selected

items from the results display.
Retest
(add to
Sample
Tab)
Adds the selected items to the Sample Tab to be retested.
Export
Exports selected results to a text file (*.txt), MS Excel file

(*.xls), or XML file (*.xml). Save for future reference.
10
6. TROUBLESHOOTING
6.1 Error Messages
Explanation of Error Messages generated by the communications programming of
the LuMatic instrument:
Error Code(s)/Problem:
001 Invalid Command
Solution:
Check command for spelling and validity.
003 Invalid Row Number,

%d
Row number must be in valid range (1-12)
004 Invalid Device Number,

%d
Device number must be in valid range (0-3), contact

Customer Service
005 Invalid wiper value, %d
Wiper number must be in valid range (0-3), contact

Customer Service
006 Invalid Cal Value, %d
Value must be in valid range (20-110), contact

Customer Service
007 Invalid Offset Value, %d
Offset value must be in valid range (5-250) contact

Customer Service
008 Invalid Gain Value, %d
Gain value must be in valid range (5-250) contact

Customer Service
009 Invalid Number of

Steps, %d
Number of steps must be in valid range (0-1200)
010 Invalid Code
Invalid code entered
012 Invalid Serial ID
Serial ID must be number (1-99999)
102 Calibration Data

Checksum Failure
Internal checksum doesnt match, contact customer

service
103 EEPROM not

acknowledging
201 Extra movement of
(%d) needed at home
EEPROM didnt acknowledge command, contact

customer service
Check that microplate is seated properly in the plate
carrier. If using removable strips (8 or 12 well) check
that they are seated properly in the microplate.
Check that X motor is not jammed
211 Extra steps needed in X

direction
212 X Mover Jammed.
Position of Jam: -734,
Destination Req: -854
Check motor and shuttle travel for debris, tightness in

rotation or encoder not turning. Repeat test without a
plate to determine if the plate is causing the skid plate
to stall the motor.
85
Error Messages (Continued)
86
301 Pot %d, wiper %d,
Setting %d returned
%d (not 24)
Solution:
Contact Customer Service
302 Pot %d, wiper %d not

ack
303 Pot %d, wiper %d not

ack
411 Offset search error
Background error. Record the difference between the

Read Value and the Target Value. If Read Value is 0
then there is a fault in the light conversion and read
circuits. If Read Value is higher than the target value
then the likely cause is lack of warm-up time or light
leakage into the PMT mounting block. (If the unit has
been dismantled in any way, then check that
everything 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 OFF
Value using the "RDREF()" command. See fault
finding procedure for Error "503 Reference
adjustment out of range".
Read Value = 0
Cable connections may not be correctly seated.
(It is important that all connections are exactly
correct both destination and orientation). If any
cable has been plugged into the wrong socket
and the machine has been powered on, some
circuits may have been damaged which will show
as multiple faults.
High Voltage board may not be working (see LED
lamp on board).
Error Messages (Continued)

503 Reference adjustment
is out of range
9001 Cal Page Size >64

bytes
Solution:
Open the Communications window and look at the
read plate results. Check the LumiFactor. If it is
significantly out of range of >1.2 and <0.8, check the
reference LED reading in the same results.
Possibly the Reference LED has drifted from
calibration or is not working at all.
Ref LED NOT working If ON Value is
approximately equal to OFF Value i.e. both are
<10,000=>LED is not switching ON.
If ON Value is approximately equal to OFF Value and
both are ~200,000=>LED is not switching OFF. If ON
Value ~200,000+/-20%, and OFF value is <10,000
then Ref LED is working.
Ref LED drifted check that the Reference LED
Value against the value when it was calibrated. If
this is >+/-10% difference then contact Customer
Service.
9002 Util Page Size >64

bytes
9003 Error Page Size >64

bytes
87
6.2 COM Port Settings

Generally the communication (COM) port setting of the PC and the LuMatic will
not require adjustment. However, the following steps are included just in case the
user needs to view the setting or make an adjustment to the setting.
6.2.1 PC Communication (COM) Port Setting

Follow the steps below to view or adjust the computers COM Port Setting.
Steps
Click on the START

button on the PC menu
bar:
Double-Click on the START button on the PC
Click on Control Panel
The Control Panel

window will open up;
double-click on
System
88
PC Communications (COM) Port Setting (Continued)

Steps
The System Properties

window will open; click
on the Hardware tab
Click on the Device

Manager button
From the Device

Manager window,
double click on the
Ports (COM & LPT)
folder.
89
PC Communications (COM) Port Setting (Continued)

Steps
Click on the Ports

(COM & LPT) folder;
view the USB-to-Serial
Comm Port setting.
Follow the steps under
Section 6.2.2
LuMatic
Communication (COM)
Port Setting to ensure
that the microplate
readers COM port
setting matches the
COM port setting on
your PC.
NOTE: In this instance
the COM port is COM3,
your system may
display a different port.
6.2.2 LuMatic Communication (COM) Port Setting

To adjust the LuMatic COM Port setting to match the computers COM Port setting,
follow these steps:
Steps
Power on the LuMatic
Model 4401 CLIA
Microplate Reader. The
instrument will
annunciate a beeping
sound; the LED power
indicator will light (the
light will pulse/flash);
and the instrument will
warm-up. When the
instrument has
completed its
initialization process, it
will annunciate three
short beeping sounds
signaling it is
operational.
90
The computer screen will display the LuMatic logo:
Steps
LuMatic Communication (COM) Port Setting (Continued):

and then the Plate Layout screen will display:
Plate Layout Display
Click on the Settings tab

on the LuMatic
Manager Menu Bar to
access the Comm Port
setting:
Click on the Comm
Port, Database,
Report option on the
Settings drop down
menu:
91
Steps
The Software Settings

window will open:
Click on the
Communication Port
drop down menu, and
scroll up or down to
locate the COM port
setting that matches
the COM port setting
from your PC (see
Section 6.2.1 PC
Communication
(COM) Port Setting).
Click to highlight the
setting and then click
on the OK button to
save the setting.
NOTE: The COM port
setting will remain at
this setting until it is
changed.
92
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 email us the information.
93
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 job
completion the patient information and assay results can be downloaded into a text
file following the same protocol. The protocol for data exchange is listed below.
Import Process:
o
Select Management > LIS Import
Choose a file containing LIS requests.
Requested tests are added automatically to request list in the Sample

tab.
Export Process:
o
In the Report tab, user will select records and press Export button.
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 Save
button.
Record Definitions and Specifications
Record Type Definitions

H|
Indicates a Header Record, primarily for informational

purposes.
P|
Indicates a Patient Record and is patient specific information.
OBR|
Indicates a Requested Assay to be run for the preceding

patient.
OBX|
Results from the Requested Assay preceding.
L|
Indicates the End of the file.
A|
Append this information to the preceding record; may be

used on any record.
Figure 8.1-1 Record Type Definitions
94
A Carriage return is used to indicate the end of the line (220 is the maximum).
Record Layout Specifications
Minimum Requirements
Message Header
H|
Append to the Previous Record
A|
Patient Segment
Transmission Seq#| Patient-ID |
P|
Observation Order Segment
OBR| Sequence Number|
Patient Name |
Assay
Name
Observation
Value |
Units |
Sex|
Nature of
abnormal
checking
Address|
| Doctor
Result Observation Segment
OBX|
Sequence Number|
Value Type|
Reference Abnormal
Range |
Flags |
Message Terminator
L|
Sequence Number|
Patient
Count | Line Count | Batch Number
NOTE: A solid bar (|) indicates the field is for future use. The bar delimiter is
necessary for correct formatting within the record.
95

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Model 4401

Doc 4401 09/2010 Rev A

5.2.3 Lot # Registration Menu .............................................................................................................. 43

5.2.5 Sample Database ......................................................................................................................... 46

5.2.6 Settings ........................................................................................................................................ 53

5.2.7 Maintenance ................................................................................................................................ 61

5.2.8 Security Menu Options ................................................................................................................ 63

5.3.3 Add Samples Tab ......................................................................................................................... 78

WARNING! FOR IN-VITRO DIAGNOSTIC USE

Monobind LuMatic Model 4401 Operators Manual Rev. A

The LuMatic Model 4401 CLIA Microplate Reader is a user-friendly instrument

1.1.3 Key Features

1.1.4 Principles of Operation

Monobind LuMatic Model 4401 Operators Manual Rev. A

1.2 Warning Markings Inscriptions davertissement

Monobind LuMatic Model 4401 Operators Manual Rev. A

1.2.2 Safety Terms Terminologie de Sret

indicates an injury immediately

indique le risque immdiat de dommages

indicates an injury hazard not

indique quun risque de dommages qui

indicates a hazard to property, including

indique un risque a la proprit

These terms may appear in this manual:

WARNING statements identify conditions

Ces rapports identifient les conditions ou

CAUTION statements identify conditions

Ces rapports identifient les conditions ou

Monobind LuMatic Model 4401 Operators Manual Rev. A

1.3 Safety Precautions

Monobind LuMatic Model 4401 Operators Manual Rev. A

Install as Directed Install the instrument on a sturdy, level surface capable of

Provide Proper Ventilation Refer to the installation instructions for details on

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

Do Not Operate in Wet/Damp Conditions

Do Not Operate In An Explosive Atmosphere

Monobind LuMatic Model 4401 Operators Manual Rev. A

1.4 Operating Precautions

1.4.1 Instrument Warm Up Time

Monobind LuMatic Model 4401 Operators Manual Rev. A

HRP 1x10-18 moles, ALP 1x10-21 moles

Linear Dynamic Range:

Less than 2.5 x 10-4

Spectral Response Range:

96 wells in opaque strip tray or plate

100 - 240VAC, 50-60Hz 90W maximum.

Reads 96 wells in approximately two minutes

NRTL Listed, CE mark

Monobind LuMatic Model 4401 Operators Manual Rev. A

PC interface software (included) with

CD-ROM and internet upgrades

Microsoft Windows XP, Vista or Windows 7

Microsoft Windows XP 256 RAM; USB port

Secondary menu options:

Create/edit protocols, import/export data, LIS

RLU, Factor, Standard, %RLU, Point to Point,

User-programmable open system, selectable

Store control data, print Levey-Jennings or

USB cable provided

All metal enclosure

Design and instrument specifications are subject to change without notice.

Monobind LuMatic Model 4401 Operators Manual Rev. A

Customer copy of packing list

Unpacking instructions sheet