Stat Fax 4200 ®

MICROPLATE READER

OPERATOR’S MANUAL

© Awareness Technology Inc. 2008 Stat Fax® 4200 Operator’s Manual Revised 2018 Rev. K
 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 Principles of Operation ...................................................................................................... 2
1.2 Warning Markings Inscriptions d’avertissement ...................................................................... 3
1.2.1 Safety Symbols Le Symboles de Sûreté ........................................................................... 3
1.2.2 Safety Terms Terminologie de Sûreté .............................................................................. 3
1.3 Safety Precautions ................................................................................................................... 4
1.3.1 Disposal ............................................................................................................................. 5
1.4 Specifications ........................................................................................................................... 6
1.5 Installation ................................................................................................................................ 8
1.5.1 General .............................................................................................................................. 8
1.5.2 Installation/Preparation...................................................................................................... 8
1.5.3 Load Paper ........................................................................................................................ 9
1.5.4 Touch Screen Description ............................................................................................... 10
1.6 Parts and Controls ................................................................................................................. 10
1.7 Checkout Procedure .............................................................................................................. 11

2. Operating Procedures ................................................................................... 12

2.1 Operating Precautions ........................................................................................................... 12
2.2 General Selections ................................................................................................................. 12
2.3 Main Display Menu Options ................................................................................................... 13
2.3.1 Run Test .......................................................................................................................... 14
2.3.2 Settings ........................................................................................................................... 15
2.3.2.1 External Output ....................................................................................................... 16
2.3.2.2 USB Mouse Connection ......................................................................................... 16
2.3.3 Manage Tests .................................................................................................................. 17
2.3.3.1 Multi-Test ................................................................................................................ 18
2.3.4 Utilities ............................................................................................................................. 20
2.4 General Operation ................................................................................................................. 22
2.4.1 Bichromatic Differential Operation .................................................................................. 22
2.4.2 Loading and Formatting a Plate ...................................................................................... 22
2.4.2.1 Locating Controls .................................................................................................... 23
2.4.3 Reading a Plate ............................................................................................................... 25
2.4.4 Unit of Measurement Codes (Unit Code) ........................................................................ 26
2.4.5 Offset Absorbance........................................................................................................... 27
2.4.6 Lamp Saver and Lamp Warmup ..................................................................................... 27
2.5 Modes of Operation ............................................................................................................... 28
2.5.1 Absorbance Mode ........................................................................................................... 30
2.5.1.1 Filter Selection ........................................................................................................ 30
2.5.1.2 Blank ....................................................................................................................... 31
2.5.2 Factor Mode .................................................................................................................... 31
2.5.3 Single Standard Mode ..................................................................................................... 34
2.5.4 Multi-Point Modes (Point to Point, Regression and Cubic Spline) .................................. 36
2.5.4.1 - % Absorbance ...................................................................................................... 38
2.5.4.2 – Editing a Curve .................................................................................................... 39
2.5.4.3 – Select Axes .......................................................................................................... 40
2.5.4.4 – Controls ............................................................................................................... 42
2.5.5 Cut Off Mode ................................................................................................................... 43
3. Cleaning and Maintenance ............................................................................ 50
3.1 Cleaning ................................................................................................................................. 50
3.1.1 Exterior ............................................................................................................................ 50
3.2 Maintenance........................................................................................................................... 50
3.2.1 Calibration and Linearity.................................................................................................. 50
3.2.2 Storage ............................................................................................................................ 51

4. Troubleshooting............................................................................................. 52
4.1 Messages and Flags .............................................................................................................. 52
4.2 Error Messages ...................................................................................................................... 55

5. References...................................................................................................... 56

6. Optional Accessories .................................................................................... 57

6.1 Thermal Printer Paper ............................................................................................................ 57
6.2 Dri-Dye® Check Strips ............................................................................................................ 57

7. Information ..................................................................................................... 58

8. Appendix A SF_Capture ................................................................................ 59

9. Appendix B Updating Firmware.................................................................... 60

10. Appendix C Touchpad Alignment .............................................................. 60

1. Introduction

1.1 Applications

1.1.1 Intended Use

The Stat Fax® 4200 is a compact, microprocessor-controlled, multi-purpose photometer
system designed to read and calculate the results of assays, which are read in 96 well
microplates or strip trays.

The Stat Fax® 4200 may be used for in-vitro diagnostics. It is a user-programmable open
system with selectable plate formatting, alphanumeric test naming, automatic interpretation
options, duplicate well options, curve plotting and editing, flags and error messages from
which the user can create a menu of pre-programmed assays for instant recall.

Stat Fax® 4200 is intended to be used as a stand-alone instrument without a PC but it has
a connection in the event a user wishes to download results. For a PC-controlled
microplate reader ask about the ChroMate TM Model 4300.

It 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 company’s instrument service provider to arrange for training if
the information provided in this manual is not sufficient for your applications.

FOR IN-VITRO DIAGNOSTIC USE

POUR L'USAGE DIAGNOSTIQUE IN VITRO

1.1.2 Summary of the Instrument

This instrument reads monochromatically (optional) or bichromatically (optional) and has
two models:

• Four-filter model (405, 450, 492, and 630 nm)

• Six-filter VIS model (405, 450, 492, 545, 600, and 630 nm)

Substitute filters in the range of 405 nm - 750 nm are available on special order models.

Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K 1

Summary of the Instrument (continued)

The Stat Fax® 4200 accepts all standard microplates. Trays containing microstrips may also
be read whether they are 12 wells in length, 8 wells or even partial strips.

 Pre-programmed Modes - The basic calculations are permanently stored in

memory and include several single and multi-point equations. Provisions are
made in certain cases for reading specimens in duplicate and/or using the
mean reading in calculations. Each calculation mode is described in detail in
Section 2.5-Modes of Operation. The following calculation modes are
offered: Factor, Single Standard, Point to Point, Regression, Cubic Spline,
and Cut Off.

 User-programmable Memory

The Stat Fax® 4200 Microplate Reader’s 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.

1.1.3 Principles of Operation

The Stat Fax® 4200 Microplate Reader’s optical system provides an economical and low
maintenance design which reads 8 wells simultaneously. A 96 well plate can be read and
printed in the absorbance mode in approximately twenty seconds.

Light from a lamp installed in a sealed light-tight compartment is filtered using a rotating
filter wheel. The filtered light is then divided into 8 channels using a fiber optic bundle.

The plate carrier precisely positions each row of 8 wells into the optical path for reading.
Light passing through the 8 wells is directed to 8 photo-detectors.

The filter wheel moves to a second position to read the 8 wells at a second wavelength.
Using bichromatic differential absorbance values corrects for optical imperfections in the
plastic wells and removes the effects of meniscus and turbidity.

The photo-detectors generate electronic signals which are amplified and interpreted by the
instrument circuitry.

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

1.2.2 Safety Terms Terminologie de Sûreté

These terms may appear on the product: Les marques sur le produit:
These terms may appear in this manual: Les marques dans l’opérateur manuel:

DANGER Indicates an injury immediately accessible as you read this marking

DANGER Le “de marque: Indique le risque immédiat de dommages (assessible tandis que vous
DANGER” lisez la marque)

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
Ces rapports identifient les conditions ou les pratiques qui pourraient
marque: WARNING”
avoir comme conséquence les dommages ou les pertes humaines.
CAUTION CAUTION statements identify conditions or practices that could result
in damage to this product or other property.

Ces rapports identifient les conditions ou les pratiques qui pourraient

L’ATTENTION “Le de marque:
avoir comme conséquence les dommages a ce produit ou a toute
CAUTION”
autre propriété.
BIOHAZARD BIOHAZARDS are biological agents that can cause disease in
humans. Lab workers handling potentially infectious materials must
use universal precautions to reduce the risk of exposure to these
agents.

Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K 3

1.3 Safety Precautions
To assure operator safety and prolong the life of your instrument, carefully follow all instructions outlined
below.
Read Instructions Take 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 Many diagnostic assays utilize materials that are potential biohazards.
Apparel WARNING: Always wear protective apparel and eye protection while using this
instrument.
Follow Operating WARNING: Do not use this instrument in a manner not specified by the
Instructions manual, or the protection provided by the instrument may be impaired.
Use Proper Power WARNING: Use only the power supply specified for this product and certified
Supply for the country of use.
Observe All Terminal WARNING: To avoid fire or shock hazard, observe all ratings and markings on
Ratings the instrument. Consult this manual for further ratings information before
making connections to the instrument.
Install as Directed This instrument should be installed on a sturdy, level surface capable of safely
supporting the instrument’s weight 12 lbs (5.4kg). The mounting surface should
be free of vibrations.
Provide Proper Refer to the installation instructions for details on installing the product so it has
Ventilation proper ventilation. The instrument should be surrounded by the following
clearances: 10cm around perimeter of unit, 10cm on top, 1.27cm bottom (1/2”).
Do Not Operate WARNING: Do not operate this instrument with covers and panels removed.
Without Protective
Covers
Avoid Exposed WARNING: Do not touch exposed connections and components when power is
Circuitry present.
Avoid Excessive Dust Do not operate in an area with excessive dust.
Do Not Operate With WARNING: If you suspect there is damage to this instrument, have it inspected
Suspected Failures by a qualified service person.
Do Not Operate in WARNING: Do not operate instrument in wet/damp conditions.
Wet/Damp Conditions
Do Not Operate In An WARNING: Do not operate instrument in an explosive atmosphere.
Explosive Atmosphere
Operating Precautions Be sure to run a sufficient number of controls in each assay. If controls are not
within their acceptable limits, disregard test results.
Keep Instrument CAUTION: Solvents such as acetone or paint thinner will damage the
Surfaces Clean and instrument.
Dry √ Do not use solvents to clean the unit. Avoid abrasive cleaners; the display
overlay is liquid-resistant, but easily scratched.
√ 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

4 Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K

 CAUTION! L’ATTENTION!
WARNING: If any materials are overturned during operation,
immediately set the power switch to OFF. 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 matériaux,

coupez immédiatement le courant. Placez le commutateur électrique a
AU LOIN(0). Traitez le matériel comme biohazardous, utilisant
approprie nettoient et des méthodes de disposition.

1.3.1 Disposal
Dispose of according to local regulations.

Before the instrument is removed from the laboratory for disposal or servicing, it must be
decontaminated.

Decontamination should be performed by a well-trained authorized person, observing all

necessary safety precautions. Instruments to be returned must be accompanied by a
decontamination certificate completed by the responsible laboratory manager. If a
decontamination certificate is not supplied, the returning laboratory will be responsible for
charges resulting from non-acceptance of the instrument by the servicing center or from
any authority’s intervention.

CAUTION! L’ATTENTION!
Caution: Treat all components during use and disposal as you would any
biohazardous material.

L’Attention: Utiliser et disposer des matériaux de la même manière que vous

utilisé et disposer des matières infectieuses.

Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K 5

1.4 Specifications
Photometric

Linear Measurement Range: ..................................... 0.0 to 4.0 Absorbance Units (A)

Photometric Accuracy: ............................................... +/- (1% +/- 0.010) 0.0 through 1.5 ABS

+/- (2% +/- 0.010) 1.5 through 3.0 ABS

Stability: ...................................................................... Drift of no more than 0.005A in 8 hours

Light Source: .............................................................. Halogen lamp with lamp saver feature

Standard Wavelengths: .............................................. 405, 450, 492, and 630nm. 6-filter: 405,
450, 492, 545, 600, and 630nm. Filter
options from 405nm to 700nm.

Filter Type: ................................................................. IAD hardcoat interference, 10nm half

bandpass

Vessel:........................................................................ Standard 96-well microplates or strip

trays

Electronic

Display:....................................................................... Interactive touch screen 4.5”x3.5”

(14.5cm) LCD color graphic display

Printer: ........................................................................ Thermal 64 characters per line, plus

graphics

Power Requirements:................................................. 100-240V AC, 1.2A, 50-60Hz (universal

input, auto sensing)

Microprocessor: .......................................................... eZ80, 64K EEPROM

Memory: ..................................................................... 2MB Flash Memory, 1MB RAM Memory

Interface: .................................................................... USB mouse; USB port used for thumb

drive interface for firmware updates
(mouse not included; thumb drive not
included)

6 Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K

Software

Speed: ........................................................................ Reads absorbance of 96 wells in about

10 seconds

Calculation Modes:..................................................... Factor, Single Standard, Point-to-Point,

Regression, Cubic Spline, Cut Off Mode

Test Storage: .............................................................. Stores 120 tests; stores all parameters

including wavelengths, calculations, unit
codes, linear and normal ranges,
standard values, test names, and
previous standard curve.

Other

Enclosure: .................................................................. Flame-retardant ABS/PVC alloy material

cover with aluminum base

Dimensions: ............................................................... Approximately 13.5”Wx17”Dx8-1/4”H

(34.3cmx43.2cmx21cm)

Weight ........................................................................ 12 lbs (5.5kg)

Certifications: ............................................................. CE, ETL listed,

NRTL listed (USA/CAN)

Recommended Environmental Conditions

Indoor use
Mains supply voltage: Fluctuations not to exceed + 10% of
nominal voltage
Recommended Operating Temperature .................... 18-35°C
Recommended Operating Humidity: .......................... less than 80%
Storage Temperature: ................................................ 10 to 50°C

NOTE: Although it may be safe to operate in these conditions, it may not be

suitable for the performance of your tests. Check with your reagent supplier.
Accessories sold separately: Thermal paper (contact your dealer)

Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K 7

1.5 Installation

1.5.1 General
Carefully unpack the instrument, removing it from its plastic bag. Report any damage to
your freight carrier at once. Retain the original packing material for future use in the event
that the instrument is shipped to another location or returned for service. Items packed with
the instrument include:

1.5.2 Installation/Preparation
Instrument Placement Place the instrument on a flat working surface capable of safely
and Use supporting the weight of the instrument, approximately 5.4 kg (12lbs).
A clearance of at least 8cm (3”) around the instrument is required to
assure optimal ventilation.
Assure Clean Power The circuit used should be substantially free of large voltage
Availability 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 data that was not stored in
nonvolatile memory will be lost. If power fluctuations or loss are
frequent, an Uninterruptible Power Supply (UPS) is recommended.
Power Switch Position The ON/OFF switch is on the back of the instrument. The power
switch should be in the OFF position (down) before connecting the
power cord to the power supply.

8 Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K

Power Cord With the power switch in the OFF [down] position, insert the DC
Requirements connector attached to the end of the power supply module cable to
the instrument. Insert the mating end of the AC power cord to the
inlet of the power supply module, and plug the other end of the AC
power cord into an AC outlet. Use only the power cord and supply
module specified for this product and certified for the country of
use.

For 110-120 V used in the United States, use a UL listed cord set
consisting of an 18 AWG, Type SPT-1 two conductor cord
maximum 3 meters (10 feet) in length, rated 7 A, 125 V, with a
polarized parallel blade type attachment plug.

For 220-240 V used inside the United States, use a UL listed cord as
above, except rated 250V.

For other locations, use the power cord certified for the country of
use.

1.5.3 Load Paper

Printer paper
Figure 1.5.3-2 Printer paper installed
compartment
release button Pull up at least 1 inch of paper and then
A press the compartment cover down until it
snaps closed. Turn the power switch OFF
and back ON. The wake up routine will
follow. The printer will print several lines.
Figure 1.5.3-1 Paper compartment lid

Locate the roll of thermal printer paper P/N Wait until it has stopped. If there is no
150003. printing, the internal printer is disabled
(reference Section 2.3.2 Settings).
Press down on the printer paper compartment
release button (A) and the paper compartment lid NOTE: The printer manufacturer strongly
will open. recommends the use of thermal paper
part number 150003 to reduce lint and
Place the paper roll in the well such that the
extend printer life. Contact your dealer for
leading edge of the paper feeds upward from the
replacement rolls.
front of the printer as shown.

Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K 9

 1.5.4 Touch Screen Description
The touch screen responds to touch pressure which causes electrical contact between the
conductive and resistive layers. The touch screen provides the following advantages:

• High touch resolution

• Pressure sensitive, works with any stylus
• Not affected by dirt, dust, water or light
• Durable technology

1.6 Parts and Controls

The following terms are used in this manual to describe parts and controls of the Stat Fax® 4200
microplate reader. More details on the operation of each feature are provided in Section 2-
Operating Procedures.
A) Door open
B
B) Printer and printer
paper compartment C
C) Display

Figure 1.6-1 Front of instrument

A) Power supply module

B) Power switch
C) Power supply connection
D) USB Port
E) USB ports: mouse and thumb drive
F) Stylus

Figure 1.6-2 Connections

10 Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K

1.7 Checkout Procedure
Follow this procedure to verify that the instrument is ready for use.

Checkout Procedure
Visually confirm the following items:
√ Power supply is connected to the unit and the power plug is inserted into an AC
outlet.
√ Power switch is set to OFF.
The instrument is now ready for power-up. Confirm that the instrument responds as
described.
√ Set the power switch to the ON position.
The printer will print out the
instrument model, serial
AWARENESS
number, laboratory name (if TECHNOLOGY
defined under the Settings INC
menu Laboratory Name option;
the default is no laboratory Stat Fax
name), firmware version,
revision level, date and time 4200
(Figure 1.7-2).
Loading …
Click Tray Out and make sure
Figure 1.7-1 Power up Screen Display
door opens and microplate tray
extends out.

Click Tray In and make sure

door closes.
Stat Fax 4200 Ver: Eng-01.26.00
Before running any assays,
read at least one plate in Laboratory Name (if defined)
absorbance mode to verify
plate carrier operation Serial Number: 9999

If the instrument still produces 12-20-2018 16:34:40

results other than those
Figure 1.7-2 Representation of the power up
described here, refer to Section
print out
4. Troubleshooting, or contact
your dealer for assistance.

Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K 11

2. Operating Procedures

2.1 Operating Precautions

• 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.

2.2 General Selections

For every test, the instrument will require a mode selection and filter combination. Thereafter,
only those questions that pertain to the mode selected will be asked. In the Absorbance Mode, for
example, there are no further selections required.

Review the following questions before beginning a test (refer to the reagent kit insert for required
information):

1. How will absorbance readings be converted into a final result?

2. Is a Blank required? Which filters are optimal? (primary and differential
wavelengths)
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 one 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 that 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 which cutoff should be labeled as negative?
10. Will only a partial plate be read?

12 Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K

2.3 Main Display Menu Options
The Main display menu options are:

• Run Test explained in Section 2.3.1

• Settings explained in Section 2.3.2

• Manage Tests explained in Section 2.3.3

• Utilities explained in Section 2.3.4

• Tray In – the plate carrier transports the plate into the and the door closes

• Tray Out – the door opens and the plate carrier extends out for the ease of
inserting a test plate on the carrier

Lamp status indicator Time Reprint button

Figure 2.3-1 Main display menu screen

The status line displays the Lamp status (OFF or ON) and the time. The printer button (PRN) has
two options: 1. to advance the paper, 2. to reprint the last 64 lines of data. NOTE: PRN does not
print graphs, only data.

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 2.3.1 Run Test
The Run Test feature allows the operator to recall user tests that have been stored in the
instrument’s memory (see example in Figure 2.3.1-1). The Stat Fax® 4200 stores up to
120 complete test setups in nonvolatile memory, making it easy for the user to recall
complete test configurations.

Select Run Test from the Main display. Tests programmed and saved on the instrument
will display sorted by their test number. Each of the test parameters, including the mode,
wavelengths, standards, units, and the ranges are all stored for reuse.

Blanks and standards (including entire standard curves) that have been read are also
saved. When the test is recalled, the user has the option of using the previous saved
curve or reading a new one.

1 – TSH
Cancel
2 – T3
SAMPLE
3 – T3 Uptake
4 – T4 <<
5 – T4 Total
6 – FSH v >>
7 – hCG
Select
8 – LH
9 – Testosterone
By #

Figure 2.3.1-1 Run Test - Example of stored test menu

Feature Function
Arrows Use the ^ UP and V DOWN arrow keys to highlight
selection; use the >> side arrows to advance to
the next screen; use << arrows for previous
screen
Select The highlighted test is executed once the Select
key is pressed
By # Allows the user to enter a specific test number to
recall.
Cancel Returns to the main power on display screen

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 2.3.2 Settings
Select the Settings option on the main display screen and the Unit Settings will display:

Unit Settings
Arrow Keys: Utilize the
Adjust Date and Time ^ arrow keys to scroll up and
down the list of options or
Printer Setup press the option directly
v from the list; the option will
Lamp Control
highlight
Plate Assignment Select

Sound Settings
Done Select: The high-lighted
Laboratory Name
option is executed once the
External Output Select key is pressed

Plate Print Format

Figure 2.3.2-1 Unit Settings

The functions of the Unit Settings features are:

Feature Function
Adjust Date and Provides access to the Set Time option Hours, Minutes, Seconds
Time as well as Month, Day, Year
Printer Setup Enables/disables the internal printer. Graphs can be printed when
the internal printer is set to OFF. Allows the contrast to be
adjusted light to dark. It is advisable to print at contrast level set at
3. Higher t levels may degrade after several lengthy printouts.
Text height options are small, medium and large.

Lamp Control Lamp idle feature will automatically turn off the lamp; the default
setting is 600 seconds (10 minutes). Lamp Warm up range is
between 45 and 240 seconds (45 seconds is the default setting).
Plate Assignment Offers plate format options such as 8 way or 12 way; duplicates
side by side.
Sound Settings Provides access to and status of touch screen sound settings (ON
or OFF), and sound volume (1=low to 8=high). Sound options are:
start up sound, key press & release and other sounds (i.e. sound
when the Quit button is selected).
Laboratory Name Allows a laboratory named to be entered; laboratory name will
print out (reference Checkout Procedure in Section 1.8).
External Output Allows external output to be turned ON or OFF. Reference the
External Output Section 2.3.2.1 for setup instructions.
Plate Print Format User can select either a 1 to 12 or H to A printout of plate data.

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 2.3.2.1 External Output
To enable output to be sent to a personal computer, a user must use a software
application such as SF_Capture to transmit and store data from the Stat Fax® 4200
and have the following in place:

• Power on the instrument and set the External Output to “ON” by: (a) selecting
Settings from the main display, (b) highlight External Output on the Unit Settings
display, (c) press the Select button, (d) on the External Output Setup display
select the ON button and ensure that the Status field displays ON, (e) select the
Save button, and then, (f) select the Done button.
• Connect the type B end of the USB cable to the type B port of the
instrument.
• With the personal computer (PC) powered on, connect the type A end of the USB
cable to a USB port on the PC.
Type A

Figure 1 USB Type A port and connector

Type B

Figure 2 USB Type B port and connector

2.3.2.2 USB Mouse Connection

To use a USB mouse with the Stat Fax® 4200, be sure that the mouse is connected
to the USB port A on the instrument before the instrument is powered on. If the
mouse is plugged in after the instrument is on, it will not be operational.

16 Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K

 2.3.3 Manage Tests
Detailed descriptions of the Modes of Operation may be found in Section 2.5.

Select Manage Tests on the Main display screen and the following options will display:

Create Test Multi-Test

Edit Test Clone Test

Delete Test

Print Test List Exit

Figure 2.3.3-1 Manage Tests options

The functions of the Manage Tests options are:

Feature Function
Create Test Allows user to:

• Name the test

• Select the Mode (Absorbance, Factor, Single Standard, Point to

Point, Regression, Cubic Spline, Cut Off)

• Select the Primary Filter

• Select the Differential Filter

• Enable/Disable Blank (Yes or No) Note: Default is ‘yes’ for

Single Standard Mode.
• Set number of blank replicates

• Interpretation Criteria (Positive and Negative interpretation, or

Normal and Valid Ranges)
• Select Units
• Input Decimals

• Enable % Absorbance (Yes or No)

• Input number of Standards
• Input number of Sample Replicates

• Select Axes
• Controls management (Enable; name; number of replicates;
input low/high ranges; input action to take (i.e. warn, continue
or end test); record Lot Number; input expiration date; location).

Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K 17

 Feature Function
Create Test • Set Blank Minimum and or Maximum
(Continued) • Set Normal Range Low and or High
• Define Valid Range Low and or High
Edit Test Used to change test programming. Editing a test will erase any
stored blank or standard values for that test
Delete Test Allows selection and deletion of user programmed and stored
tests
Multi Test User can select a number of different tests to be read in the same
plate. (2, 3, or 6 in an 8-way formatted plate or 2 or 4 in a 12-way
formatted plate)
Clone Test Duplicates an existing test.
Print Test List Prints the list of stored tests (maximum 120 tests)
Exit Returns to the Main power on display screen

2.3.3.1 Multi-Test
With the Multi-Test option, any stored assay regardless of mode or wavelength may
be used. The read direction (8 or 12-way) will be the instrument was set to read in the
Settings menu. With the 8-way format, two, three or six different test modes may be
run in the same plate; with the12-way format up to four tests may be run.

If any test is selected to run in the multi-test plate that has a stored curve, the user
will be prompted to accept, print or discard the curve.

The instrument will prompt the user to select the next test. To read less than a full
plate, select “Cancel” after choosing the last test to be run.

Print Plate will enable the location and absorbance reading of each well to be printed,
as shown on the plate map.

In order to print the test information and results, after each test is run, select
“Results”.

If all tests in the multi-test plate have the same filter configuration, then the plate is
read only one time. The user can select “Print Plate” and “Results” for each test.

If different filters are used for any other test(s), the plate will automatically be read
again.

There is no option to select number of wells in Multi-Test.

18 Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K

Multi-Test (Continued)
Example 1

1) Two tests with different wavelengths have been selected to run.

2) Select “Read Plate” and the first test will run. When that test is done, use the
“Results” button to printout out data. (Print Plate can be used to verify well and
well absorbance reading location.)

3) The next test will be recalled and run automatically.

Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K 19

Multi-Test (Continued)
Example 2,

1) Three tests – 2, 1 and 3 - were selected to run;

2) Reading of the Standards in the second test, TSH, results in an invalid curve.

3) The next test in the plate will not run. Multi-test mode is ended.

20 Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K

2.3.4 Utilities
Select Utilities from the Main display screen and Utility Menu options used for diagnostic
purposes will display. The arrow keys control movement up and down the list of options as
well as using the edge of the list to scroll up and down. To select an option from the list,
press the Select button. Press the Done button when finished.

Utility Menu
Change Access Level Arrow Keys: Utilize the arrow
^ keys to scroll up and down
Show Version Details
the list of options or press the
option directly from the list;
Erase ALL Tests v the option will be highlighted.

Recall Calibration Select: The high-lighted

Select
option is executed once the
Print Unit Settings Select key is pressed.
Done
Filter Voltages Done: Returns to the Main
display screen
Check Wheel Speed

Figure 2.3.4-1 Utility Menu options

The functions of the Utility Menu options are:

Feature Function
Change Access Level Display prompts to ‘Enter Pass Code’. Contact
Technical Support for pass code.
Show Version Details Displays current firmware version, model, serial
number, build date, current time.
Erase All Tests Display will prompt “Please Confirm. Erase All Tests?”
press OK to clear all tests or Cancel.
Recall Calibration Allows user to restore the original factory settings,
including calibration.
Print Unit Settings Prints all information about an individual instrument’s
calibration settings and other information.
Filter Voltages Displays real time filter wheel voltages; provides
option to print them out. Acceptable range is from 2 to
10 v.
Check Wheel Speed Displays results as the wheel speed is tested.

Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K 21

2.4 General Operation

2.4.1 Bichromatic Differential Operation

The option to operate this instrument using differential absorbance readings is available for
every mode. The absorbance readings at the differential wavelength are subtracted from
the absorbance readings at the operating (primary) wavelength. Use of the bichromatic
differential absorbance values corrects for optical imperfections in the plastic wells and
removes the effects of meniscus and turbidity.

Whenever possible, differential reading is recommended because precision is significantly

improved.

In order to preserve sensitivity, it is important not to choose a differential wavelength where

the chromophore being assayed exhibits substantial absorbance. To test your
chromophore, read a darkly colored solution in the Absorbance Mode at the operating
wavelength with no differential filter, and again at the operating wavelength with the
differential filter selection. If the two absorbance readings are within 10% of each other,
then bichromatic differential reading is beneficial. If the difference between the absorbance
readings with and without a differential wavelength is greater than 25%, then the
chromophore is absorbing at or near the differential wavelength and bichromatic reading at
this wavelength is probably not desirable.

If no bichromatic wavelength is selected, exercise every measure to enhance repeatability.

2.4.2 Loading and Formatting a Plate

The footprint for most 96 well plates and strip trays are similar and will fit the Stat Fax®
4200. Test the fit of an empty plate before beginning an assay. Place the plate into the
instrument with well A-1 at the rear right corner so that row 1 is going into the reader first.
As you press the first row back and down you will feel slight tension on the plate stretching
the carrier so that the front fits in. The plate requires a snug fit.

Place the plate into the

instrument with well A-1 at the
right rear so that row 1 is
going into the reader first.
When using a single Blank(s)
always is located in A1.

22 Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K

Loading & Formatting a Plate (Continued)
When using a strip tray, make sure wells are pushed down into tray so that they will not
cause the plate to jam on entry. Use care that well tabs do not extend over other wells.

Do not place the tabbed ends of strips in row 1; they should be in row 12. Be sure to place
the strips in the order in which Blanks, Calibrators and Samples are to be read.

When using a Blank, it should always be located in Well A1. If replicate blanks are used,
they will be placed on the plate map as the next well from A1, to B1 if reading 8 way strips,
or below if reading 12 way strips.

For best results, do not fill wells completely; 200-250µl depending on well total volume is
the maximum fill recommended.

Use caution when attaching labels to plates so they do not jam in reader or interfere with
read path.

The microplate may be formatted for 8 way or 12 way placement of Blanks, Controls and
Samples. Selecting 8 way or 12 way is done on the Settings screen, Plate Alignment
option.

2.4.2.1 Locating Controls

Unlike Blank(s), Controls can be located in any location of the strip carrier.

The default location is the well or wells adjacent to the Blank(s). To use a different
location, while enabling the use of Controls, select the Location field (Figure 2.4.2.1-
1).

TEST DEFINITION Control 1

Enabled YES
# Replicates 1
Name Control 1 ^
Range Low v
Range High
Action Warn, Continue Edit
Lot Number Done
Expiration [mm.yyyy]
Location

Figure 2.4.2.1-1

Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K 23

 A new screen will open up showing the current plate map (Figure 2.4.2.1-2). Controls
can be placed anywhere on the map by manually selecting a well location. The well
location selected will then be displayed in the box “Location”.

In the example below, a cutoff mode assay is being run and strips are to be read in
the 8 way read direction. Duplicate Positive Controls (PC) and a single Negative
Controls (NC) are being used in the assay (Figure 2.4.2.1-2).

The Negative control is to be read in well A5. This is done by selecting that box on
the screen. The new location is presented in the Location box. .

H G F E D C B A H G F E D C B A
NC PC PC 1 PC PC 1
2 2
3 3
4 4
5 Location NC 5 Location
6 6 A5
7 7
8 Select 8 Select
9 9
10 10
11 Default 11 Default
12 Cancel 12 Cancel

Figure 2.4.2.1-2 Figure 2.4.2.1-3

When using replicates, only the location of one Control is to be selected. The
replicates will follow according to the Plate Alignment chosen in Settings.

NOTE: If the
H G F E D C B A
Controls or their NC 1
Replicates overlap 2
due to the plate 3
setup, an error flag 4
will display to warn PC PC 5 Location
the operator: 6 A5
7
“Enabled control 8 Select
location already 9
identified!” 10
11 Default
12 Cancel

Figure 2.4.2.1-4

24 Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K

2.4.3 Reading a Plate
Select and confirm a stored test, or create a new test. The display will show the plate,
indicating where Blanks, Standards and Controls are located.

The example below (Figure 2.4.3.-1) shows the layout of a Point to Point mode assay that
has duplicate Blanks, 5 Standards, using all three Controls read in duplicate.

H G F E D C B A P1
S6 S5 S4 S3 S2 S1 B2 B1 1
2 1 C3 C3 C2 C2 C1 C1 2
10 9 8 7 6 5 4 3 3
4
5
6
7
8
9
10
11
12
QUIT # Samples Read Plate

Figure 2.4.3-1
If fewer than a full plate of wells is to be read, select the ‘#Samples’ button. Once the
plate has been read (via Read Plate), absorbance readings will be on the display for each
well.

There is an option of ‘Print Plate’ to print out the plate as seen on the display. This is
especially useful when running Absorbance mode.

Select the Results button and the test results will be printed. The message “Run another
plate of samples” will appear. The user can choose to read more or to Quit.

Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K 25

 2.4.4 Unit of Measurement Codes (Unit Code)
To access the list of Unit Codes, select Manage Tests, select Create Test select any mode
except Absorbance, and advance to the Test Definition Final Page. Select the Units field
and the list will display. Seven units of measurement designations are stored for labeling
the concentration column plus a blank customizable selection.

TEST DEFINITION Final page

Exit
Interpretation Mode Pos/Neg
Units Conc ^
Decimals 1 v
# Sample Replicates 1
Edit
<< Save Run Print

Figure 2.4.4-1 Test Definition Final page

Conc

IU/mL
e
g/dL

mmol/L

umol/L

ppm

ppb

Customize

Figure 2.4.4-2 Units of Measure

Create a customized label for the concentration column by selecting the option
‘Customize’ from the list of units available. A keyboard will display, enter the desired
label name and press Enter. The custom Unit label will display in the Unit field.

26 Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K

2.4.5 Offset Absorbance
If Differential Filter is set to "None", then the Offset Absorbance field is displayed.

TEST DEFINITION
Name Exit
Mode Absorbance
^

Primary Filter 405 v

Differential Filter 630
Blank NO Edit
Offset Absorbance
Print Save Run

Test Definition – Offset Absorbance field displayed

The user should determine the value of the Offset Absorbance. This value will be
subtracted from the absorbance readings to correct for the meniscus effect for the test that
is being run. Select the Offset Absorbance field and enter the user-determined offset
absorbance value. Press the Save button to save the settings.

Offset Absorbance feature is only needed when both of these conditions occur:

 Monochromatic reading
 No blank well

It is a mathematical blank to correct for the differential between air and liquid with a
meniscus.

To determine the user-entered value, pipette a volume of wash buffer into a well that is
equal to the total volume in test wells at the read time.

For example, if the well has 100µl of Substrate Part A per 100µl of Substrate Part B, plus
50µl of stop solution, the total volume in the test wells at the read time is 250µl. Therefore
read the absorbance of 250µl of colorless wash buffer to determine the correct value for
the Offset Absorbance. Typical values are from .250 to .400A.

2.4.6 Lamp Saver and Lamp Warmup

After a period of inactivity, there is a lamp time-out feature that will automatically turn off
the lamp. The default setting is 600 seconds (10 minutes). This can be adjusted using the
Lamp Control feature located in Settings. The range is 30 to 3600 seconds.

Lamp Warmup has a default setting of 45 seconds. This can also be adjusted from the
Lamp Control feature. The range is 45 to 240 seconds.

Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K 27

2.5 Modes of Operation

Mode Function
Absorbance See Section 2.5.1 - Absorbance mode reads and prints the
monochromatic or bichromatic differential absorbance at the user-
selected wavelengths. Blanking is optional. Most Assays require a mode
other than Absorbance Mode. In this mode, no calculations are made -
only absorbance values are reported.
Factor See Section 2.5.2 – In Factor Mode, the endpoint absorbance readings
will be multiplied by a user-entered factor to calculate a result.
Single Standard See Section 2.5.3 – Single Standard mode reads a calibrator, and then
calculates concentrations based on a single-point standard curve
passing through the point (0,0). A blank is required to determine the
(0,0) point. A factor (equal to the concentration of calibrator ÷ the
absorbance of calibrator) is generated in this mode, and then multiplied
by subsequent absorbance readings to determine concentrations.
Point to Point See Section 2.5.4 – The plate reader accepts a number of calibrators
and calculates concentrations based on the point-to-point calibration
curve. The resulting calibrator curve is a series of lines connecting the
calibrator points, which may be entered in ascending or descending
order of absorbance. The direction of slope between the first and
second calibrators determines the direction of the curve. If the direction
of the curve changes direction, the curve will be flagged as being
“invalid” and no interpretations will be printed.
Unknown samples are calculated as follows:
The unknown sample’s absorbance is read and compared to the
absorbance of the calibrator.
An unknown Sample, with absorbance higher than the calibrator with
the highest absorbance value, is calculated using a line that passes
through the two Calibrator points with the highest absorbance value. An
unknown Sample with absorbance lower than the lowest Calibrator
absorbance is calculated from the line that passes through the two
Calibrators with the lowest absorbance values.

28 Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K

Regression See Section 2.5.4- In Regression mode, the instrument accepts a
number of Calibrators and calculates concentration values based on a
best-fit curve (linear regression).
Cubic Spline See Section 2.5.4– Cubic Spline Mode accepts a minimum of 3 and a
maximum of 8 calibrators and calculates concentrations based on the
Cubic Spline (constrained) calibration curve.

Calibrator materials of known concentrations are used to calibrate the

instrument so that concentrations of unknown Samples are calculated
from the generated curve. The resulting calibrator curve is a smooth
curve connecting the Calibrator points, which may be entered in
ascending or descending order of absorbance. A constraining algorithm
is applied to prevent curve overshoot.
Cut Off See Section 2.5.5 – Cut Off Mode provides Cut Off Value (COV) formula
options and Quality Control options.

Mode options are located under Manage Tests on the Main display screen. Select Create
Test and the Test Definition screen will display; select the Mode field and the list of Mode
options will display.

Each of the seven (7) modes follow the same basic pattern of options, with other variables
available for selection dependent upon the mode being used.

SELECT MODE
Absorbance Cancel
Factor
Single Standard ^
Point to Point
Regression v
Cubic Spline
Cut Off Select

Available Modes

CAUTION!
CAUTION! Verify mode selection matches with the test kit package
insert or manufacturer’s instructions before reporting test results! Always
include normal and abnormal controls.

Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K 29

 2.5.1 Absorbance Mode
NOTE: Every user should begin by learning to use the Absorbance Mode.

Absorbance mode will read and print sample absorbance values at user selected
wavelengths. All of the other modes that follow function the same way but use the
measured absorbance to calculate final results. Press Manage Tests, press Create Test,
and the Test Definition window will display.

TEST DEFINITION
Name Exit
Mode Absorbance
^

Primary Filter 405 v

Differential Filter 630
Blank NO Edit
Print Save Run

Initial Test Definition display

2.5.1.1 Filter Selection

To edit the Primary or Differential Filter wavelength fields, use the arrow keys to advance
to the desired field, and then press the Edit key. The Select Filters screen will display the
available filter options; make a selection and press the Select button.

SELECT FILTERS
SELECT FILTERS None Cancel
405 Cancel 405 ^
450 ^ 450
492 v 492 v
630 Select 630 Select

Primary Filter display Differential Filter display

If Differential Filter is set to "None", then the Offset Absorbance field is displayed.

30 Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K

 2.5.1.2 Blank
The Test Definition Blank screen will display when the Blank field is selected. This screen
allows for the Blank setting to be enabled (Yes or No); and for inputting the number of
Replicates. Press the Done button when editing is completed.

TEST DEFINITION Blank

^
Enabled Yes v
# Replicates 1
Edit
Done

Test Definition Blank display

NOTE: All of the other modes function the same way but use the measured absorbance
to calculate final results.

2.5.2 Factor Mode

Factor Mode will read and print sample concentrations at user selected wavelengths. A
previously determined factor is entered by the operator, and the measured absorbance is
then multiplied by the factor to obtain concentration.

To operate in Factor Mode, press Manage Tests and then press Create Test. A Test
Definition window will display. Press the Mode field and the Select Mode screen will
display. Use the arrow keys to advance through the list to the desired mode and press
Select or use the stylus to highlight Factor.

SELECT MODE
Absorbance Cancel
Factor
Single Standard ^
Point to Point
Regression v
Cubic Spline
Cut Off Select

Select Mode screen

The Factor Mode Test Definition first page will display the available options: Name, Mode
(Factor), Primary Filter, Differential Filter, and Blank. Enter each as done in Absorbance
Mode Section 2.5.1.

Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K 31

Factor Mode (Continued)
The Test Definition 2nd page will display and allow editing of Factor and Controls. Use the
arrow keys to advance through the options, press the Edit key to change the values
displayed on the screen.

NOTE: The Factor comes from the assay package insert or from a previous assay in the
Single Standard Mode.

TEST DEFINITION 2nd page

Exit
Factor 10
^
Control 1 Disabled
Control 2 Disabled v
Control 3 Disabled Edit

<< Save Run >>

Factor Mode Test Definition – 2nd Page

Selecting any of the Control fields will open a Test Definition Control screen with options to
enable the Control (Yes or No), input the number of Replicates, Name the Control, input a
Low and a High Range, set the Action to Take (Warn, Continue or End Test), input a Lot
Number, input an Expiration Date, and input a Location. Press the Done button when
finished with editing fields.

TEST DEFINITION Control 1

Enabled NO
# Replicates 1
Name Control 1 ^
Range Low v
Range High
Action Warn, Continue Edit
Lot Number Done
Expiration [mm.yyyy]
Location

Test Definition Control screen

32 Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K

Factor Mode (Continued)
The Factor Mode Test Definition Final Page will display and allow editing of Interpretation
Mode, Units, Decimals, and number of Sample Replicates. Selecting the Units field on the
Factor Mode Test Definition – Final Page will display a list of seven measurement
designations including a customizable selection, which are stored for labeling the
concentration column (see Section 2.4.3 Unit of Measurement Codes). Use the arrow keys
to advance through the options and press the Edit key to change the values of the
selections on the screen. Press Save to save the selections.

TEST DEFINITION Final page

Exit
Interpretation Mode Pos/Neg
Units Conc ^
Decimals 1 v
# Sample Replicates 1
Edit
<< Save Run Print

Factor Mode Test Definition - Final Page

Selecting the Interpretation Mode field will open the Test Definition Interpretation screen for
editing the Interpretation controls. Use the arrow keys to advance through the options,
press the Edit key to change the value of the selection.
NOTE: Double
TEST DEFINITION Interpretation check that the
Interpretation Pos/Neg ^ interpretation
Pos >= v information you
Neg < entered is correct.
Reversed NO Edit
Done

Factor Mode Test Definition –Pos/Neg Interpretation

Editing the Interpretation Pos/Neg field will display the Interpretation Normal option for
inputting Normal Range Low, Normal Range High, Valid Range Low, or Valid Range High.

Press the Done button when editing is completed.

TEST DEFINITION Interpretation

Interpretation Normal ^
Normal Range Low v
Normal Range High
Valid Range Low Edit
Valid Range High Done

Factor Mode Test Definition –Normal Interpretation

Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K 33

 2.5.3 Single Standard Mode
To operate in Single Standard Mode, select Manage Tests and then select Create Test.
The Test Definition screen will display. Select the mode field and the Select Mode screen
will display the list of modes. Use the arrow keys to scroll through the mode selections to
the desired selection and press Select, or use the stylus to highlight Single Standard.

SELECT MODE
Absorbance Cancel
Factor
Single Standard ^
Point to Point
Regression v
Cubic Spline
Cut Off Select

Select Mode screen

The Single Standard Mode Test Definition first page will display the available options:
Name, Mode (Single Standard), Primary Filter, Differential Filter, and Blank. These
operate the same as in the Absorbance Mode except that the Blank is required, therefore
‘YES’ will automatically appear in the Blank enabled field.

TEST DEFINITION
Name Exit
Mode Single Standard
^

Primary Filter 405 v

Differential Filter 630
Blank YES Edit
Print Save >>

Single Standard Mode Test Definition – 1st Page

The Single Standard Mode Test Definition 2nd page will display and allow editing of
Standard Concentration, Controls, and number of Standard Replicates. Use the arrow
keys to advance through the options and press the Edit key to change the values of the
selections on the screen.

TEST DEFINITION 2nd page

Exit
Standard Conc 10
# Std Replicates 1 ^
Control 1 Disabled
Control 2 Disabled v
Control 3 Disabled Edit

<< Save Run >>

Single Standard Mode Test Definition –2nd Page

34 Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K

Single Standard Mode (Continued)
Selecting any of the Control fields will open a Test Definition Control screen with options to
enable the Control (Yes or No), input the number of Replicates, Name the Control, input a
Low and a High Range, set the Action to Take (Warn, Continue or End Test), input a Lot
Number, input an Expiration Date, and input a Location. Press the Done button when
finished with editing fields.

When Controls are read in duplicate, the mean of the duplicates can be calculated and that
one value used, or, each Control can be required to fall within the ranges individually. The
instrument will prompt ‘Check Mean?’ once duplicate Controls are selected.

TEST DEFINITION Control 1

Enabled NO
# Replicates 1
Name Control 1 ^
Range Low v
Range High
Action Warn, Continue Edit
Lot Number Done
Expiration [mm.yyyy]
Location

Test Definition Control screen

When setting the Controls, if there are Replicates, the Location will be the starting location.
If the Controls or their Replicates overlap due to the plate setup, an error flag will display
while running the test to warn the operator.

The Single Standard Mode Test Definition Final page will display and allow editing of
Interpretation Mode, Units, Decimals, and number of Sample Replicates. Use the arrow
keys to advance through the options; press the Edit button to change the values of the
selections on the screen. Press Save to save the selections.

TEST DEFINITION Final page

Exit
Interpretation Mode Pos/Neg
Units Conc ^
Decimals 1 v
# Sample Replicates 1
Edit
<< Save Run Print

Single Standard Mode Test Definition - Final Page

Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K 35

Single Standard Mode (Continued)
Selecting the Interpretation Mode field will open the Test Definition Interpretation screen for
editing Interpretation controls. Use the arrow keys to advance through the options, press
the Edit key to change the value of the selection. Press the Done button when editing is
complete.
NOTE: Double check
TEST DEFINITION Interpretation that the interpretation
Interpretation Pos/Neg ^ information entered is
Pos >= v correct.
Neg <
Reversed NO Edit
Done

Single Standard Mode Test Definition - Interpretation

2.5.4 Multi-Point Modes (Point to Point, Regression and Cubic Spline)

The Stat Fax® 4200 offers three varieties of multi-point modes: Point-to-Point, Regression
and Cubic Spline.

In Point to Point and Cubic Spline modes, the standard concentrations must be read in
either increasing or decreasing order.

All of the Test Definition screens, use of Controls, and items related to Interpretations work
the same for each type of multi-point. Use the arrow keys to scroll through the mode
selections to the desired selection and press Select or use the stylus to highlight
selections.

MULTI-POINT
MODES

Select Mode screen

36 Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K

Multi-Point Modes (Point to Point, Regression and Cubic Spline)
(Continued)
The Test Definition first page displays the available options.

TEST DEFINITION
Name Exit
Mode Point to Point
^

Primary Filter 405 v

Differential Filter 630
Blank NO Edit
Offset Absorbance 0.000
Print Save Run

Test Definition – 1st page with Offset Absorbance field displayed

If Differential Filter is set to "None", then the Offset Absorbance field is displayed

The Test Definition 2nd page includes use of % Absorbance, number of Standards,
number of Standard replicates, selection of Axes, and the use of Controls.

Note: Point-to-Point and Regression require at least two Standards, Cubic Spline mode
requires at least three.

TEST DEFINITION 2nd page

% Absorbance NO Exit
Standards 5
# Std Replicates 1 ^
Axes Y=Abs X=Conc
Control 1 Disabled v
Control 2 Disabled
Control 3 Disabled Edit

<< Save Run >>

Test Definition –2nd Page

Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K 37

 2.5.4.1 - % Absorbance
The % Absorbance option is used with multipoint uptake assays.

% Absorbance assigns a value of 100% to the first Standard, which must be entered from
darkest to lightest.

An additional calculation (%A/A0) is calculated, which is the absorbance of the sample

divided by the absorbance of the first calibrator, or “percent of first calibrator”. The first
calibrator is considered 100%, and all subsequent samples are calculated as percent of
calibrator.

The %Abs value is displayed in the Interpretation field of the report. This mode does not
support ln, logit or log scales for the absorbance axis. Upon recall of a % Absorbance
mode test, the user will be asked whether to reread the highest value Standard.

Select the Standards field and the Standards Test Definition screen will open.

Standards Exit
Number of Standards 3 ^
Std1 Concentration 10.0 v
Std2 Concentration 20.0
Std3 Concentration 30.0 Edit
Done

Standards Test Definition screen

38 Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K

 2.5.4.2 – Editing a Curve
When Duplicate Standards are used, the curve may be edited by deleting one of any pair
of standards. For Point to Point and Regression Modes, the minimum is two; for Cubic
Spline Mode, the minimum is three.

Once the curve has been read, select the ‘Edit’ option before the ‘Accept’ or ‘Print’
options. Using the stylus, select the duplicate standard to be deleted.

An “X” will appear in the

location on the display
that is to be deleted.
The curve will be
recalculated and the
options to Accept, Edit,
Print or Quit will be
available.

Example of editing a curve with Duplicate Standards

As shown in the example below, Duplicate Standards are labeled as ‘Dupl I’ and ‘Dupl II’.

Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K 39

 2.5.4.3 – Select Axes
Axes selections include linear-linear, ln (= natural log)-linear, linear-ln, or ln-ln
calculations. A logit-log calculation is also available. Absorbance, or ln of (1000 *
absorbance), is always on the “Y” axis. Concentration, or ln of concentration, is always on
the “X” axis.

SELECT AXES
Y=Abs X=Conc Cancel
Y=Ln(1000*Abs) X=Conc ^
Y=Abs X=Ln(Conc) v
Y=Ln(1000*Abs) X=Ln(Conc) Select
Y=Logit(Abs) X=Log(Conc)

Calculation Explanation
“Y= ABS, X=CONC” Both the absorbance data (y) and the
concentration data (x) are linear.
“Y=Ln (1000*ABS), X=Conc” The natural log of the absorbance is plotted
against the concentration. The absorbance
values are multiplied by 1000 before taking the
logs.
“Y=ABS, X=Ln(Conc)” Absorbance is plotted against the natural log of
the concentration.
“Y= Ln (1000*ABS), X=Ln(Conc)” The natural log of the absorbance is plotted
against the natural log of the concentration.
“Y= Logit(Abs), X= Log(Conc)” Select to calculate unknowns using the
equation: Abs Logit = Ln [(sample/0 cal) / 1-
(sample/0 cal)]
Refer carefully to the Reagent Kit product insert for correct selection.

NOTE: Remember log of 0 is undefined so do not set concentration to 0 (zero) on a

logarithmic scale.

Point-to-Point and Regression modes require at least two standards, Cubic Spline
requires at least three standards.

40 Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K

Select Axes (Continued)
The Log / Logit option is available under the Point to Point Mode, Regression Mode,
and the Cubic Spline Mode. Concentrations must be greater than zero in this axes
mode. The program automatically increases the number of Standards by one.

Log / logit SELECT AXES

option –
Y=Abs X=Conc Cancel
the program Y=Ln(1000*Abs) X=Conc ^
automatically
increases the
Y=Abs X=Ln(Conc) v
number of Y=Ln(1000*Abs) X=Ln(Conc) Select
Standards by Y=Logit(Abs) X=Log(Conc)
one.

When using a non-linear axis:

If absorbance of a Sample is > than the highest calibrator's absorbance, “ ****** “ is

reported for the Concentration

• Standards must be read in descending absorbance order

• If no Standard programmed has a 0.0 concentration assigned to it, an additional

Standard is forced, and the concentration for that Standard is replaced with a
series of stars [ **** ]

Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K 41

 2.5.4.4 – Controls
Selecting any of the Control fields will open a Test Definition Control screen with
options to enable the Control (Yes or No), input the number of Replicates, Name the
Control, input a Low and a High Range, set the Action to Take (Warn, Continue or
End Test), input a Lot Number, and input an Expiration Date. Press the Done button
when finished with editing fields.

When Controls are read in duplicate, the mean of the duplicates can be calculated
and that one value used, or, each Control can be required to fall within the ranges
individually. The instrument will prompt ‘Check Mean?’ once duplicate Controls are
selected.

TEST DEFINITION Control 1

Enabled NO
# Replicates 1
Name Control 1 ^
Range Low v
Range High
Action Warn, Continue Edit
Lot Number Done
Expiration [mm.yyyy]
Location

Test Definition Control screen

The Test Definition Final page will display Interpretation Mode, Units, Decimals, and
number of Sample Replicates.

TEST DEFINITION Final page

Exit
Interpretation Mode Pos/Neg
Units Conc ^
Decimals 1 v
# Sample Replicates 1
Edit
<< Save Run Print

Test Definition – Final Page

Selecting the Interpretation Mode field will open the Test Definition Interpretation screen
for editing the Interpretation controls.

TEST DEFINITION Interpretation

NOTE: Double check
Interpretation Pos/Neg ^
that the interpretation
Pos >= v
information you
Neg <
entered is correct.
Reversed NO Edit
Done

Test Definition –Pos/Neg Interpretation

42 Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K

Controls (Continued)
Editing the Interpretation Pos/Neg field will display the Interpretation Normal option
for inputting Normal Range Low, Normal Range High, Valid Range Low, or Valid
Range High.

Press the Done button when editing is completed.

TEST DEFINITION Interpretation

Interpretation Normal ^
Normal Range Low v
Normal Range High
Valid Range Low Edit
Valid Range High Done
Test Definition –Normal Interpretation

2.5.5 Cut Off Mode

Many qualitative assays interpret results based on a pre-determined, or cut off, absorbance
such that a sample absorbance greater than the cut off absorbance is interpreted as
positive (or negative) and samples with absorbance less than the cut off be interpreted as
negative (or positive). Companies that manufacture these assays use a variety of means of
obtaining (reading or calculating) the essential cut off point. Stat Fax® 4200 employs a
universal equation that can be adapted to fit most commercially available kits by inserting
user-entered factors ‘X’ and/or ‘Y’ as well as a coefficient ‘F’. The equation is (X)(mNC) +
(Y)(mPC)+F = COV (Cut Off Value).

In the Cut Off Mode, ‘X ‘is multiplied by the mean of the negative controls. ‘Y’ is multiplied
by the mean of the positive controls, and each of these two numbers is added to ‘F’ to
arrive at the Cut Off Value (COV). The ‘X’, ‘Y’ and ‘F’ factors can be positive or negative
numbers, one or zero, or decimals such as 0.5 to fit the test requirements provided in the
Kit package insert or as instructed by the Kit manufacturer. In this mode be careful to enter
all QC parameters completely and correctly. They are usually provided as Absorbance
limits.

To operate in Cut Off Mode, select Manage Tests and then select Create Test. The Test
Definition screen will display. Select the Mode field and the Select Mode screen will display
the list of modes. Use the arrow keys to scroll through the mode selections to the desired
selection and press Select or use the stylus to highlight Cut Off.

SELECT MODE
Absorbance Cancel
Factor
Single Standard ^
Point to Point
Regression v
Cubic Spline
Cut Off Select

Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K 43

Cut Off Mode (Continued)
The Cut Off Mode Test Definition first page displays the available options: Name, Mode
(Cut Off), Primary Filter, Differential Filter, and Blank. Enter wavelength and blank as
shown in Section 2.5.1 Absorbance Mode.

TEST DEFINITION
Name Exit
Mode Cut Off
^

Primary Filter 405 v

Differential Filter 630
Blank NO Edit
Print Save >>

Sample of Cut Off Mode Test Definition 1st page

The Test Definition Cutoff 2nd page allows editing of Cut Off Value (COV), values of X, Y,
and F; Negative Control; Positive Control; and QC Criteria.

TEST DEFINITION Cutoff

COV= X*mNC+Y*mPC+F Exit
X= 1
Y= 1 ^
F= 0 v
Neg Ctrl Enabled
Pos Ctrl Enabled Edit

QC Criteria COV, mNC, mPC

<< Save Run >>

Sample of Cut Off Mode Test Definition 2nd page

44 Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K

Cut Off Mode (Continued)
Selecting any of the Control fields will open a Test Definition Control screen with options to
enable the Control (Yes or No), input the number of Replicates (1 to 5), Name the Control,
input a Low and a High Range, set the Action to Take (Warn, Continue or End Test), input
a Lot Number, input an Expiration Date, and input a Location. Press the Done button when
finished editing fields.

TEST DEFINITION Neg Ctrl

Enabled YES
# Replicates 1
Name Neg Ctrl ^
Range Low 0.200 v
Range High 0.400
Action End Test Edit
Lot Number 1222 Done
Expiration [mm.yyyy] 12.2013

Test Definition Control Screen

When Cutoff Controls are read in multiples, the mean of the replicates
can be calculated and that value used, or each Control can be required
to fall within the ranges set. “Check Mean” will display once replicate
Controls are selected.

mean

Example - Cut Off Mode output showing mean

Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K 45

Cut Off Mode (Continued)
Set the Controls by selecting the appropriate control field.

Note: When setting the Controls, if there are Replicates, the Location will be the starting
location. If the Controls or their Replicates overlap due to the plate setup, an error flag will
display while running the test to warn the operator. (Reference Section 2.4.2.1)

Selecting the ‘COV =’ field will open the Select COV Formula screen. In addition to the
universal equation, Stat Fax® 4200 offers three more optional formulas.

Where COV is the Cutoff Absorbance Value, mNC is the mean of the Negative Controls;
mPC is the mean of the Positive Controls. X, Y, and F are user-entered coefficients that
can have any positive or negative numerical value including zero and 1.

Select COV Formula

X*mNC+Y*mPC+F Exit
See explanation X*mNC+F ^
of choices in y*mPC+F
the table below. X*mCC+F v
Select

Highlight the desired formula from the list and press the Select button.

COV Formula options

COV Formula Explanation

X*mean(NC) + Y*mean(PC) + F Universal equation, used to calculate the cutoff
value based upon readings or positive and/or
negative controls.
• In this equation, NC and PC are used to determine
the COV (cutoff value).
• Enter the variables provided in the package insert.
The software calculates the mean of the positives
and the mean of the negatives.
X * mean(NC) + F • Use this equation if only a negative control is used
to determine the COV.

46 Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K

Cut Off Mode (Continued)

COV Formula Explanation

Y * mean(PC) +F • Use this equation if only a positive control is used
to determine the COV.
• For interpretation, you may choose 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.
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 absorbance
values of the cutoff controls when test is run
• Blanking is optional, dependent upon the Assay
Kit
• 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.

Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K 47

Cut Off Mode (Continued)
Selecting the QC Criteria field opens the Test Definition Cutoff Quality screen:

(mPC / mNC):
Enter the lowest Backup to be used in case
acceptable ratio for controls read are too high or
the mean of the TEST DEFINITION Cutoff Quality too low.
positive controls to ^
the mean of the Minimum COV v
negative controls Maximum COV
Note: ‘Reversed’ field is ‘YES’
Edit
when Low Absorbances are
(mPC/mNC)>= Done
(mPC – mNC): Enter Positive and High Absorbances
(mPC-mNC)>=
the lowest are Negative.
acceptable difference Reversed
for the mean
absorbance of the
positive controls
minus the mean
absorbance of the
negative controls.

Quality Criteria screen

The Blank is not subtracted in the Reverse Cutoff option. Pay close attention to “<” less
than and “>” greater than symbols when entering control limits in this case.

The Cut Off Mode Test Definition final page displays Interpretation Mode, Units, Decimals,
and number of Sample Replicates.

TEST DEFINITION Final page

Exit
Interpretation Mode Pos/Neg
Units Abs/COV ^
Decimals 3 v
# Sample Replicates 1
Edit
<< Save Run Print

Cut Off Mode Test Definition - Final page

48 Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K

Cut Off Mode (Continued)
By selecting Pos/Neg, Positive and Negative Interpretations can be entered. It is not
necessary to enter both Positive and Negative. These can also be set to be evaluated in
the reverse, where Positive is LESS than or equal to (<=) the value entered.

NOTE: Double check

that the COV
calculations and
interpretation
TEST DEFINITION Interpretation
^
Pos >= 1.000 *COV v
Neg < 1.000 *COV Edit
Reversed NO Done

Cut Off Mode Test Definition – Interpretation

Press the Done button when finished editing.

Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K 49

3. Cleaning and Maintenance

3.1 Cleaning

3.1.1 Exterior
CAUTION: Solvents such as acetone or thinner will damage the instrument! Use only water
and recommended cleaners! Avoid abrasive cleaners. The display area is liquid-resistant,
but is easily scratched.

The exterior of the instrument may be cleaned with a soft cloth using plain water. If
needed, a mild all-purpose (nonabrasive) cleaner may be used. A 10% solution of
chlorine bleach (5.25% Sodium Hypochlorite) or 70% isopropyl alcohol may be used as a
disinfectant. Take special care not to spill any liquid into the read well.

3.2 Maintenance

3.2.1 Calibration and Linearity

Each instrument is calibrated during manufacturing using standards that are traceable to the
National Institute for Standards and Testing (NIST), and is tested to verify its linearity to 3A.
This preset calibration is very stable. Absolute calibration can be verified with the use of
NIST filters, or by periodic comparison to a reference instrument that is known to be
calibrated to NIST filters.

Absolute calibration can be verified using a specifically designed product called DRI-DYE®
Check Strips, available from your instrument supplier.

The best way to assure quality instrument performance is to include a sufficient number of
controls in each assay to cover the entire operational range.

In vertical photometry, the fill volume and degree of meniscus determine the pathlength; and
absorbance is proportional to pathlength. Since lab test results are typically based upon
standards rather than upon absolute absorbances, the linearity of the instrument is the more
critical indicator of instrument performance.

A reduction in linearity may be indicative of filter deterioration. In this event, filter

replacement is required for continued reliable operation. A monthly verification of instrument
linearity is generally required to comply with regulatory agencies.

DRI-DYE® Check Strips can also be used to verify linearity.

Alternately, the degree of linearity can be checked by reading a 1:2 serial dilution of a
material having a peak absorbance at or near one of the wavelengths, and observing a 1:2
ratio in the absorbance readings.

If you prepare dilutions to verify linearity, uniform pipetting (pathlength) and minimal transfer
error are important, since the tolerance limits which you will establish must take into
consideration the sources of error that are not due to the instrument.

50 Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K

Calibration and Linearity (Continued)
Pipetting errors can be identified by comparing duplicate readings. The instrument should
give the expected value ± (1% of the expected value + .01A).

For example, if the 1/4 dilution reads .520 A, then you can expect your 1/2 dilution sample to
read twice as much or 1.04 A ± [(1% of 1.04) +0.01 A], which is ± .02.

A good working instrument would then give a result between 1.02 A and 1.06 A. You will
know that your filters are deteriorating when darkly colored solutions consistently read
lower than expected.

Since the procedures for verifying the calibration and linearity of a vertical photometer are
quite cumbersome and not conducive to stringent criteria, the best way to assure quality
instrument performance is with DRI-DYE® Check Strips.

3.2.2 Storage
The instrument may be stored under the following recommended environmental conditions:

• Temperature: 10 to 50°C

• Humidity: Less than 80% relative humidity, non-condensing.

Store the instrument using original packaging if possible.

Perform the following steps before storing:

 Set the power switch to OFF and remove the power cord.
 Place the instrument in the original packaging material.
 When returning the instrument to service from storage, it is recommended that
functional tests be performed as if setting up the instrument for the first time.

Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K 51

4. Troubleshooting

4.1 Messages and Flags

Messages are displayed to alert the operator when certain limits are approached. After displaying
the warning the instrument will continue to function normally.

Flags are displayed, for example, when an invalid range is entered. They are intended to help the
user correct the problem. Some error messages appear as dialog boxes that require action in
order to clear; others appear on the display screen and appear on the printout.

Message/Flag Explanation
>10**6” Appears in Concentration Column when Concentration is
greater than 10**6
“******” 1. A sample has exceeded the absorbance of the reference
well in a log-logit test. Curve Axes is Y=Logit(Abs),
X=Log(Conc) and Absorbance >reference(zero) absorbance
value.
2. Will print if a curve with a log axis tries to log a zero, a
negative number, or an invalid curve has been read.
3. Prints in Concentration column whenever an error occurs
while calculating the concentration.
“>3” Prints in ABS column if a read absorbance is greater than
the maximum readable absorbance for the device.
“%Absorbance Mode This message will display if the user is in %Absorbance
should not be used with Mode and a standard is read which has a negative
negative absorbances!” absorbance.
“Assay Cannot Be User has tried to edit an OEM preprogrammed test that has
Edited!” flag set to prevent it from being edited.
“Cannot match test Pop up message that appears when running a test; occurs if
wavelength with filters the device cannot find filters for the wavelengths set in the
currently installed on test definition.
device!”
“Do not select the same Appears on Page 1 of Test Definition when the same
filter for primary and wavelengths are entered for the Primary and the Differential
differential” filters.

52 Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K

Messages and Flags (continued)

Message/Flag Explanation

“EQUIV” This is reported when a Sample is less than the POS

cutoff and greater than the NEG cutoff concentration.
(If it is reversed, then the sample is > value POS cutoff
and < value NEG cutoff.)
“Factory Settings Restored” One of these messages can be triggered when the
OR operator chooses to restore parameters or could be
seen at startup if the unit is forced to recover from bad
“User Settings Restored “
settings.
“Invalid Curve!” This message indicates that readings for standards
cannot be used to obtain a valid curve for the
calculation mode being used. If duplicate standards are
used, the user has the option to edit the curve if there
are enough points (minimum 3 for Point-to-Point and
Regression; minimum 4 for Cubic Spline).
“Invalid Curve – Log Error” An error in the creation of a curve or readings of a
negative absorbance will result in this message,
followed by Test Ended.
”log(<=0)” Prints in Interpretation column whenever a curve axis
mode with a log tries to log a zero or negative number.
“LOW”, “HIGH” Prints in Interpretation column whenever a value is
lower or higher than the range of values entered to
create the test.
“NEG” Negative – prints if a Sample is <NEG value (or if
reversed, sample is >NEG value).
“OUT” Blank is outside min/max range or sample is outside
low/high valid range values. Also appears in Cubic
Spline mode when the sample is outside of the range
of valid standards.
“POS” Sample is >= POS value (or if reversed, sample is
<=POS value.

Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K 53

Messages and Flags (continued)

Message/Flag Explanation
“Pos must be greater than or This message appears during test definition when the
equal to Neg!” user is defining positive/negative interpretations. A
value was entered for both the positive and negative,
but the positive value is less than the negative value
entered.
“Range Error” This indicates there is a limit to the range of numbers
that can be entered
“>Ref” Prints when a sample exceeds the absorbance of the
reference well in a log-logit test.. This is usually due to
the calibrator concentrations being entered incorrectly
or the calibrators being pipetted into the strip
incorrectly. The first, or "Zero" calibrator must have the
highest absorbance (darker) and the remaining
calibrators must be of descending absorbance and
increasing concentration.
Test Data Corrupted! Test (assay) Data (including calibration data) does not
match what was stored.
OR
OR
Test Definition Corrupted!
Test Definition does not match the data stored.

Once a test shows that it is corrupted, there is no way

to edit the test. It must be reprogrammed.
“Unable to assign control!” This message refers to control location in the test
definition. If there are Replicates, then the location will
be the starting location. If the Controls or their
Replicates overlap due to user error (plate setup -
direction or side by side duplicates can affect this) the
user is warned and the test is ended.
“When reversed, Pos must be Pop up message that appears during test definition
less than Neg!”“POS” when the user is defining Positive/Negative
interpretations; a value was entered for both the
positive and negative and the reverse was selected,
but the positive value is greater than the negative value
entered. Sample is >= POS value (or if reversed,
sample is <=POS value.
“Wrong date format This message indicates the expiration date for a control
(mm.yyyy)!” is not entered in the correct format

54 Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K

4.2 Error Messages
Error Messages are displayed when the instrument fails to operate correctly. They are intended to
help the user locate the problem. Some error messages require action in order to clear. Most
require help from technical support.

Error Message Explanation

Error 102 Open the Utility menu and select Print Unit Settings.
Provide this information to Technical Support.
Error 109 “Air Values Too Although anything that blocks the path of the light to the
Dark” photometer can cause this, a burned out lamp is usually
the cause.
“201, Read/Plate: Aborted, If an error occurs during plate movement or during running
Plate Movement Error” a test, message will display and terminate the test.
Contact Technical Support for assistance.
"i2c Bus error, 0x%02x. If restarting the instrument does not clear this message,
Unit may need service. Try contact technical support.
power-off, wait, power-on"
“Calibration Checksum Contact Technical Support
Faulty”

“Check unit Calibration” Go to the "Utilities" menu

Or
Run "Recall Calibration"
“Check Calibration”
Message will be posted “Reload Factory Settings?”. Select
YES. “Factory Settings Restored” will be printed.

Select “done to return to the main menu”

Turn the instrument off, then back on and read a plate to see
the message has been eliminated

If the message still appears, contact Technical Support.

“Default Settings Loaded” Indicates a problem was encountered and the
instrument’s settings have been returned to the same
status as when instrument was shipped from the factory.
“Error Saving Assay Data!” This indicates the instrument is not able to store assay
information into memory. If less than 120 assays have
already been stored, contact technical support.
“Factory Data Not Saved” Contact Technical Support

Factory Settings Invalid Contact Technical Support

OR

User Settings Invalid

Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K 55

Error Messages (continued)

Error Message Description

FTDI initialization error This message will be seen if the FTDI startup
initialization fails, tries again, but then fails a second
=========================== time.
Hardware Init Error (#10) =======================================

If the FTDI initialization fails again, the user will see

this message. If turning the instrument off and then
back on does not resolve the error, there is a
Troubleshooting button which requires contacting
Technical Support for a passcode.
Updating internal firmware If the system finds an older version of FTDI firmware,
this message will be displayed and the update will
happen automatically. Do not turn off the unit until the
update is complete

5. References

1. Engineering data supplied by Awareness Technology, Inc. Palm City, Florida (1987 to
current date)

2. Data on DRI-DYE® Check Strips, provided by Awareness Technology, Inc. Palm City,
Florida (1989 to current date)

56 Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K

6. Optional Accessories

6.1 Thermal Printer Paper

Reorder replacement Thermal Printer Paper Roll P/N 15003. NOTE: The printer manufacturer
strongly recommends the use of thermal paper part number 150003 to ensure the best print
quality and the effective operation of the print head. Contact your dealer for replacement rolls.

6.2 Dri-Dye® Check Strips

®
• Dri-Dye Check Strips offer an easy method of verifying proper calibration and linearity
on a routine basis. The charts provided allow simple interpretation of results. If a strip or
plate reader can repeatedly obtain acceptable results with this kit, then the instrument
demonstrates linearity, calibration, filter integrity, repeatability, and lack of stray light.
®
• Proper use of the Dri-Dye Check Strips, along with good record keeping, will constitute
compliance with most quality control and licensing agency requirements for instrument
performance verification.
®
• Dri-Dye Check Strips allow the instrument owner to perform testing that is very similar
to the Q.A./Q.C. testing initially done by the instrument manufacturer. Dye absorbance
values are determined by a reference instrument that is routinely calibrated with materials
traceable to the National Institute of Standards and Technology (NIST, formerly NBS).
Dyes are then precisely dispensed into the wells, dried, and packaged.

• Using pre-dispensed dyes reduces the degree of pipetting precision required to

reconstitute the check set strips. Since the readers look through the samples from top to
bottom, volume is proportional to path-length, and therefore, to absorbance. If a well is
reconstituted with too much water, the decrease in concentration will be corrected by the
increase in path-length. Simply stated, the system is self-correcting for random pipetting
errors up to 10%.
®
• DRI- DYE Check Strips can be ordered from your dealer.

The charts provided with these kits are designed to replace the normal calculations with easy
to visualize, built-in acceptance ranges. Kits are available for the following wavelengths:
®
o DRI-DYE Check Strips-405 - for 405nm
®
o DRI-DYE Check Strips-450 - for 450nm
®
o DRI-DYE Check Strips-492 - for 492nm

Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K 57

7. Information
In the unlikely event that a problem occurs with the instrument, please contact your instrument
supplier.

Factory Information:

Telephone: USA 772-283-6540

Fax: USA 772-283-8020
E-mail: support@awaretech.com

Mailing Address:

Awareness Technology, Inc.

1935 SW Martin Highway
Palm City FL 34990 USA

Important: When contacting us, please have the Model and Serial Number of the Stat Fax® 4200 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.

Model:__________________

Serial Number:_____________

WARNING: Instruments to be returned must be accompanied by a

decontamination certificate completed by the responsible laboratory manager. If a
decontamination certificate is not supplied, the returning laboratory will be
responsible for charges resulting from non-acceptance of the instrument by the
servicing center or from any authority’s intervention.

58 Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K

8. Appendix A SF_Capture
SF_Capture is a software program for use with this reader. Contact your dealer for a copy of the
program. To install drivers, refer to Section 2.3.2.1 External Output.

Install the program by double clicking on the setup.exe file found in the SF_Capture folder. The
installation process is the same as other software – follow the prompts until it is done.

Power on the instrument, connect the serial port to USB cable from the reader to the PC. Verify
that External Export has been switched to ON from the instrument's Settings menu

NOTE: An installation of drivers will need to be done the first time SF_Capture is installed
on a PC.
Once the cable connection is made between the reader and the PC, Windows® will pop up a
message box stating that the VNC1-A As Slave is not installed and that drivers will need to be
found.

Correct response is to let Windows® look for the appropriate driver this one time.

First, it will search for and install USB Serial Converter driver(s).

The cables can be connected and the instrument's power up can be done in any sequence. If the
instrument is OFF, but SF_Capture is open and the cable is connected to the instrument, select
ReConnect.

Select Settings. This will open a dialog box where you select the instrument type and the COM
port connected to on the PC side

Data is exported to Excel, to Notepad and to a Log file each time QUIT/Test Ended occurs.

The default location for these files is C:\4200. This can be changed from the default by using the
Browse option for the Device Root Folder.

Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K 59

9. Appendix B Updating Firmware
To update firmware, follow the instructions below. Contact your dealer or technical support if you
have any questions.

1. Erase/delete anything that is on the USB pen drive (or any USB drive used).
2. Unzip the attached file and install the folder romimage.42x on the USB drive.
3. Turn off the reader and insert the USB drive with only the one romimage.42x folder
on it into the port.
4. Place a finger on the display and then power up the reader.
5. After the instrument begins to beep you can remove your finger from the screen.
6. The update process will take about 3-5 minutes, depending upon the instrument’s
bootloader version. To determine the version installed, go to Utilities – Show Version
Details.
.

10. Appendix C Touchpad Alignment

The ‘TouchPad Align’ feature is enabled via pass code from your Administrator. This feature
provides the ability to adjust the touchpad ranges by using the stylus or the mouse.

Selection of each of the eight squares should produce numbers on the display. If an area outside
of the acceptable range is pressed with the stylus or mouse, a sound will be produced. Each of
the pairs (top, left, bottom and right) must have a difference between them of not more than 3
points, such as on the left, 17 and 20 are good, whereas 17 and 24 are not. The SAVE button will
not appear until acceptable points have been selected. It is necessary to select SAVE in order to
store the new values.

Touch Pad Align

Please carefully use a stylus to touch each of

the 8 small squares on the edges to help
Adjustment adjust the touchpad ranges. Touch as closely
square to the outside edge of the screen as possible
for best results. If the points are not close
enough (3 points apart), some pairs may be
reset.

60 Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K