Awareness Technology Stat Fax 4200 Operator's Manual

Download

Stat Fax 4200

MICROPLATE READER

OPPEE

RAATT

’

SS M

’

MAA

UAALL

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 system designed to read and calculate the results of assays, which are read in 96 well microplates or strip trays.

4200 is a compact, microprocessor-controlled, multi-purpose photometer

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

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 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 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.

4200 Microplate Reader’s software allows the operator to create, edit and

4200 Microplate Reader’s optical system provides an economical and low

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.

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

Refer to Manual

Manuel

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

DANGER

Indicates an injury immediately accessible as you read this marking

WARNING

CAUTION

BIOHAZARD

BIOHAZARDS are biological agents that can cause disease in

agents.

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

AVERTISSEMENT

Risk of Shock

Risque de Choc

Protective Ground

La Terre Electrique

(Earth) Terminal

Prise de Terre

1.2.2 Safety Terms Terminologie de Sûreté

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

DANGER Le “de marque:

DANGER”

AVERTISSEMENT! Le “de

marque: WARNING”

L’ATTENTION “Le de marque: CAUTION”

Indique le risque immédiat de dommages (assessible tandis que vous lisez la marque)

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.

Ces rapports identifient les conditions ou les pratiques qui pourraient avoir comme conséquence les dommages ou les pertes humaines.

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 avoir comme conséquence les dommages a ce produit ou a toute autre propriété.

CAUTION

L’ATTENTION

Se Rapportent a

BIOHAZARD

Risk of Infection

Risque d’infection

humans. Lab workers handling potentially infectious materials must use universal precautions to reduce the risk of exposure to these

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

1.3 Safety Precautions

below.

Refer any questions to your instrument service provider.

may void the warranty.

instrument.

Instructions

manual, or the protection provided by the instrument may be impaired.

Supply

for the country of use.

making connections to the instrument.

be free of vibrations.

clearances: 10cm around perimeter of unit, 10cm on top, 1.27cm bottom (1/2”).

Covers

Circuitry

present.

Avoid Excessive Dust

Do not operate in an area with excessive dust.

Suspected Failures

by a qualified service person.

within their acceptable limits, disregard test results.

To assure operator safety and prolong the life of your instrument, carefully follow all instructions outlined

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.

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

Wear Protective Apparel

Follow Operating

Use Proper Power

Observe All Terminal Ratings

Install as Directed This instrument should be installed on a sturdy, level surface capable of safely

Provide Proper Ventilation

Do Not Operate Without Protective

Avoid Exposed

Do Not Operate With

Do Not Operate in Wet/Damp Conditions

Do Not Operate In An Explosive Atmosphere

Operating Precautions Be sure to run a sufficient number of controls in each assay. If controls are not

Many diagnostic assays utilize materials that are potential biohazards.

WARNING: Always wear protective apparel and eye protection while using this

WARNING: Do not use this instrument in a manner not specified by the

WARNING: Use only the power supply specified for this product and certified

WARNING: To avoid fire or shock hazard, observe all ratings and markings on

the instrument. Consult this manual for further ratings information before

supporting the instrument’s weight 12 lbs (5.4kg). The mounting surface should

Refer to the installation instructions for details on installing the product so it has proper ventilation. The instrument should be surrounded by the following

WARNING: Do not operate this instrument with covers and panels removed.

WARNING: Do not touch exposed connections and components when power is

WARNING: If you suspect there is damage to this instrument, have it inspected

WARNING: Do not operate instrument in wet/damp conditions.

WARNING: Do not operate instrument in an explosive atmosphere.

Keep Instrument Surfaces Clean and Dry

CAUTION: Solvents such as acetone or paint thinner will damage the instrument.

√ 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!

utilisé et disposer des matières infectieuses.

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: 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

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

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.

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

Accessories sold separately: Thermal paper (contact your dealer)

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

1.5 Installation

frequent, an Uninterruptible Power Supply (UPS) is recommended.

power cord to the power supply.

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 and Use

Place the instrument on a flat working surface capable of safely 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 Availability

The circuit used should be substantially free of large voltage transients (Kilovolt amp loads) such as large pumps, large centrifuges, refrigerators and freezers, air conditioners, large autoclaves, ovens, and dryers. The instrument may fail to operate normally if the power supply is interrupted. If this occurs, turn the instrument off for a moment. When the instrument is turned back on, it will resume normal operation, but data that was not stored in nonvolatile memory will be lost. If power fluctuations or loss are

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

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

Power Cord

Printer paper

Requirements

1.5.3 Load Paper

With the power switch in the OFF [down] position, insert the DC 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.

compartment release button

Figure 1.5.3-1 Paper compartment lid

Locate the roll of thermal printer paper P/N

150003.

Press down on the printer paper compartment release button (A) and the paper compartment lid will open.

Place the paper roll in the well such that the leading edge of the paper feeds upward from the front of the printer as shown.

Figure 1.5.3-2 Printer paper installed

Pull up at least 1 inch of paper and then 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.

Wait until it has stopped. If there is no printing, the internal printer is disabled (reference Section 2.3.2 Settings).

NOTE: The printer manufacturer strongly recommends the use of thermal paper part number 150003 to reduce lint and extend printer life. Contact your dealer for replacement rolls.

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

1.5.4 Touch Screen Description

B A C

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 microplate reader. More details on the operation of each feature are provided in Section 2- Operating Procedures.

A) Door open B) Printer and printer paper compartment C) Display

4200

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

Visually confirm the following items:

Power switch is set to OFF.

described.

Loading …

AWARENESS

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

Checkout Procedure

√ Power supply is connected to the unit and the power plug is inserted into an AC

outlet.

√

The instrument is now ready for power-up. Confirm that the instrument responds as

√ Set the power switch to the ON position.

The printer will print out the instrument model, serial number, laboratory name (if defined under the Settings

menu Laboratory Name option; the default is no laboratory name), firmware version,

revision level, date and time (Figure 1.7-2).

Click Tray Out and make sure door opens and microplate tray extends out.

Click Tray In and make sure door closes.

Before running any assays, read at least one plate in absorbance mode to verify plate carrier operation

Figure 1.7-1 Power up Screen Display

Stat Fax 4200 Ver: Eng-01.26.00

Laboratory Name (if defined)

Serial Number: 9999

TECHNOLOGY

INC

Stat Fax

4200

If the instrument still produces results other than those described here, refer to Section

4. Troubleshooting, or contact your dealer for assistance.

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

12-20-2018 16:34:40

Figure 1.7-2 Representation of the power up print out

2. Operating Procedures

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

wavelengths)

materials of known concentrations.

4. What is the calibrator value or values?

to mean materials of unknown concentrations.

row number, and well number for each.

comparison? If so, what cutoffs or ranges are to be used for each?

the positive range will be required.

If so, results less than which cutoff should be labeled as negative?

10. Will only a partial plate be read?

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):

2. Is a Blank required? Which filters are optimal? (primary and differential

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

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

6. Will locations of one or more controls be marked? If so, indicate plate number,

7. Will acceptance cutoffs or ranges for controls be entered for automatic

8. Will a cutoff value be used to label positive samples? If so, the value that begins

9. Will a cutoff value be used to label negative samples or define an equivocal zone?

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.

Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K 13

2.3.1 Run Test

Arrows

Use the ^ UP and V DOWN arrow keys to highlight

screen

Select

The highlighted test is executed once the Select key is pressed

By #

Allows the user to enter a specific test number to Cancel

Returns to the main power on display screen

1 – TSH

2 – T3

3 – T3 Uptake

4 – T4

5 – T4 Total

6 – FSH

7 – hCG

8 – LH

9 – Testosterone

By #

Cancel

Select

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.

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

Feature Function

selection; use the >> side arrows to advance to the next screen; use << arrows for previous

recall.

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

2.3.2 Settings

Adjust Date and Time

Printer Setup

Lamp Control

Plate Assignment

Sound Settings

Laboratory Name

External Output

Plate Print Format

Printer Setup

Enables/disables the internal printer. Graphs can be printed when

Arrow Keys: Utilize the

Select

Done

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

The functions of the Unit Settings features are:

Feature Function

Unit Settings

arrow keys to scroll up and down the list of options or press the option directly from the list; the option will highlight

Select: The high-lighted option is executed once the Select key is pressed

Figure 2.3.2-1 Unit Settings

Adjust Date and Time

Provides access to the Set Time option Hours, Minutes, Seconds as well as Month, Day, Year

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.

Stat Fax® 4200 Operator’s Manual Doc. 4200 Rev. K 15

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

Create Test Multi-Test

Edit Test Clone Test

Delete Test

Print Test List Exit

Create Test

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:

Figure 2.3.3-1 Manage Tests options

The functions of the Manage Tests options are:

Feature Function

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

Print Test List

Prints the list of stored tests (maximum 120 tests)

Feature Function

Create Test (Continued)

• Set Blank Minimum and or Maximum

• 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.

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

Change Access Level

Show Version Details

Erase ALL Tests

Recall Calibration Print Unit Settings

Filter Voltages

Check Wheel Speed

Technical Support for pass code.

number, build date, current time.

Arrow Keys: Utilize the arrow

Select

Done

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

keys to scroll up and down the list of options or press the option directly from the list; the option will be highlighted.

Select: The high-lighted option is executed once the Select key is pressed.

Done: Returns to the Main

display screen

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

Show Version Details Displays current firmware version, model, serial

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

Place the plate into the

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.

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) alw

ays is located in A1.

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

Loading & Formatting a Plate (Continued)

TEST DEFINITION Control 1

Enabled YES

# Replicates 1

Name ^

Range Low v

Range High

Action Edit

Done

Location

Control 1

Warn, Continue

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.

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

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).

Figure 2.4.2.1-1

H G F E D C B A

NC 1

2 3 4

PC PC 5 Location

6 A5 7 8 Select

9 10 11 Defaul t 12 Cancel

H G

D C

B A

NC PC PC 1

2 3 4 5 Location 6 7 8 Select

9 10 11

Def ault

Cance l

G F

D C

B A PC

PC 1

2 3 4

NC 5

Location

6 A5 7 8 Select

9 10 11 Default 12 Cancel

NOTE: If the

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. .

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

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.

Controls or their Replicates overlap due to the plate setup, an error flag will display to warn the operator:

“Enabled control location already identified!”

Figure 2.4.2.1-4

S6 S5 S4 S3 S2

B2 B1

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

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.

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

Figure 2.4.3-1

2.4.4 Unit of Measurement Codes (Unit Code)

Exit

Pos/Neg

Conc ^

1 v 1

Edit

<< Save Run Print

TEST DEFINITION Final page

Interpretation Mode

Units

Decimals

# Sample Replicates

Conc

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.

Figure 2.4.4-1 Test Definition Final page

IU/mL

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

Name Exit Mode

Primary Filter 405 v

Differential Filter 630

Blank NO Edit

Offset Absorbance

Print Save Run

TEST DEFINITION

Absorbance

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

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 userselected 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

Absorbance Cancel

Factor

Single Standard ^

Point to Point

Regression v

Cubic Spline

Cut Off Select

SELECT MODE

CAUTION!

is applied to prevent curve overshoot.

options and Quality Control options.

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

Cut Off See Section 2.5.5 – Cut Off Mode provides Cut Off Value (COV) formula

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.

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

Available Modes

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.

2.5.1 Absorbance Mode

Name Exit Mode

Primary Filter 405 v

Differential Filter 630

Blank NO Edit

Print Save Run

TEST DEFINITION

Absorbance

405 Cancel 450 ^ 492 v 630 Select

SELECT FILTERS

None Cancel

405 ^ 450 492 v 630 Select

SELECT FILTERS

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.

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.

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

TEST DEFINITION Blank

Yes v

Edit

Done

# Replicates

Enabled

Absorbance Cancel

Factor

Single Standard ^

Point to Point

Regression v

Cubic Spline

Cut Off Select

SELECT MODE

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 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.

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.

Select Mode screen

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

Factor Mode (Continued)

Exit

Factor

Control 1

Control 2 v

Control 3 Edit

<< Save Run >>

Disabled

TEST DEFINITION 2nd page

Enabled NO

# Replicates 1

Name ^

Range Low v

Range High

Action Edit

Lot Number Done

Expiration [mm.yyyy]

Location

TEST DEFINITION Control 1

Control 1

Warn, Co ntinue

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.

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.

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

Test Definition Control screen

Factor Mode (Continued)

Exit

Pos/Neg

Conc ^

1 v 1

Edit

<< Save Run Print

TEST DEFINITION Final page

Interpretation Mode

Units

Decimals

# Sample Replicates

Interpretation ^

NO Edit

Done

Neg <

Reversed

TEST DEFINITION Interpretation

Pos/Neg

Pos >=

Interpretation ^

Normal Range Low v

Normal Range High

Valid Range L ow Edit Valid Range High Done

Normal

TEST DEFINITION Interpretation

NOTE: Double

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.

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.

check that the interpretation information you

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.

Factor Mode Test Definition –Normal Interpretation

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

2.5.3 Single Standard Mode

Absorbance

Cancel

Factor

Single Standard

Point to Point

Regression v

Cubic Spline

Cut Off Select

SELECT MODE

Name Exit Mode

Primary Filter

405 v

Differential Filter 630

Blank YES

Edit

Print Save

TEST DEFINITION

Single Standard

Exit

Standard C onc

# Std Replicates 1 ^

Control 1

Control 2 v

Control 3 Edit

<< Save Run >>

TEST DEFINITION 2nd page

Disabled

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 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.

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.

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

Single Standard Mode Test Definition – 1

Page

Single Standard Mode Test Definition –2nd Page

Single Standard Mode (Continued)

Enabled NO

# Replicates 1

Name ^

Range Low v

Range High

Action Edit

Lot Number Done

Expiration [mm.yyyy]

Location

TEST DEFINITION Control 1

Control 1

Warn, Co ntinue

Exit

Pos/Neg

Conc ^

1 v 1

Edit

<< Save Run Print

TEST DEFINITION Final page

Interpretation Mode

Units

Decimals

# Sample Replicates

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.

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.

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

Test Definition Control screen

Single Standard Mode Test Definition - Final Page

Single Standard Mode (Continued)

Interpretation

^ v

NO Edit

Done

TEST DEFINITION Interpretation

Pos/Neg

Pos >=

Neg <

Reversed

NOTE: Double check

MULTI-POINT

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.

that the interpretation information entered is correct.

Single Standard Mode Test Definition - Interpretation

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

The Stat Fax and Cubic Spline.

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

4200 offers three varieties of multi-point modes: Point-to-Point, Regression

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.

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)

Name Exit Mode

Primary Filter 405 v

Differential Filter 630

Blank NO Edit

Offset Absorbance 0.000

Print Save Run

TEST DEFINITION

Point to Point

% Absorbance NO Exit

Standards

# Std Replicates 1 ^

Axes

Control 1 Disabled v

Control 2

Disabled

Control 3 Disabled

Edit

<< Save Run >>

Y=Abs X=Conc

TEST DEFINITION 2nd page

(Continued)

The Test Definition first page displays the available options.

Test Definition – 1

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.

page with Offset Absorbance field displayed

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

Test Definition –2nd Page

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

2.5.4.1 - % Absorbance

Standards Exit

Number of Standards 3 ^

Std1 Concentration 10.0 v Std2 Concentration 20.0 Std3 Concentration 30.0 Edit

Done

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 Test Definition screen

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

2.5.4.2 – Editing a Curve

An “X” will appear in the

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

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.

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

Example of editing a curve with Duplicate Standards

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

2.5.4.3 – Select Axes

SELECT AXES

Cancel

Y=Ln(1000*Abs) X=Conc ^

v Y=Ln(1000*Abs) X=Ln(Conc) Select Y=Logit(Abs) X=Log(Conc)

Y=Abs X=Ln(Conc)

Y=Abs X=Conc

concentration data (x) are linear.

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.

Calculation Explanation

“Y= ABS, X=CONC” Both the absorbance data (y) and the

“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)

SELECT AXES

Cancel

Y=Ln(1000*Abs) X=Conc

v Y=Ln(1000*Abs) X=Ln(Conc) Select Y=Logit(Abs) X=Log(Conc)

Y=Abs X=Ln(Conc)

Y=Abs X=Conc

Log / logit

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.

option –

the program automatically increases the number of Standards by 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

Enabled NO

# Replicates 1

Name ^

Range Low v

Range High

Action Edit

Lot Number Done

Expiration [mm.yyyy]

Location

TEST DEFINITION Control 1

Control 1

Warn, Co ntinue

Exit

Pos/Neg

Conc ^

1 v 1

Edit

<< Save Run Print

Decimals

# Sample Replicates

TEST DEFINITION Final page

Interpretation Mode

Units

Interpretation Pos/Neg ^

NO Edit

Done

TEST DEFINITION Interpretation

Pos >=

Neg <

Reversed

NOTE: Double check

entered is correct.

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.

Test Definition Control screen

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

Test Definition – Final Page

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

that the interpretation information you

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

Test Definition –Pos/Neg Interpretation

Controls (Continued)

Interpretation ^

Normal Range High

Valid Range Lo w Edit

Valid Range High Done

TEST DEFINITION Interpretation

Normal

Absorbance Cancel

Factor

Single Standard ^

Point to Point

Regression v

Cubic Spline

Cut Off Select

SELECT MODE

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 –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 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.

4200 employs a

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

Cut Off Mode (Continued)

Name Exit Mode

Primary Filter 405 v

Differential Filter 630

Blank NO Edit

Print Save >>

TEST DEFINITION

Cut Off

COV=

Exit X= 1 Y= 1 ^ F= 0 v

Neg Ctrl Enabled

Pos Ctrl Enabled Edit

QC Criteria

<< Save Run >>

TEST DEFINITION Cutoff

X*mNC+Y*mPC+F

COV, mNC, mPC

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.

Sample of Cut Off Mode Test Definition 1

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.

page

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

Sample of Cut Off Mode Test Definition 2nd page

Cut Off Mode (Continued)

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 Neg Ctrl

When Cutoff Controls are read in multiples, the mean of the replicates

Controls are selected.

mean

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 Control Screen

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

Example - Cut Off Mode output showing mean

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

Cut Off Mode (Continued)

to determine the COV.

See explanation

Select COV Formula X*mNC+Y*mPC+F Exit

Select

X*mNC+F

y*mPC+F

X*mCC+F

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

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.

of choices in the table below.

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

4200 offers three more optional formulas.

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

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

Cut Off Mode (Continued)

and ranges.

QC criteria.

COV Formula Explanation

Y * mean(PC) +F

X*mean(CC) + 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

• 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

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

Cut Off Mode (Continued)

Exit

Pos/Neg

Abs/COV ^

3 v 1

Edit

<< Save Run Print

# Sample Replicates

TEST DEFINITION Final page

Interpretation Mode

Units

Decimals

(mPC / mNC):

(mPC – mNC): Enter

Note: ‘Reversed’ field is ‘YES’

Positive and High Absorbances are Negative.

Backup to be used in case

too low.

TEST DEFINITION Cutoff Quality

^ Minimum COV v Maximum COV

Edit (mPC/mNC)>= Done (mPC-mNC)>=

Reversed

Selecting the QC Criteria field opens the Test Definition Cutoff Quality screen:

Enter the lowest acceptable ratio for the mean of the positive controls to the mean of the negative controls

the lowest acceptable difference for the mean absorbance of the positive controls minus the mean absorbance of the negative controls.

controls read are too high or

when Low Absorbances are

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.

Cut Off Mode Test Definition - Final page

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

Cut Off Mode (Continued)

Pos >=

1.000 *COV v

Neg < 1.000 *COV Edit

Reversed NO Done

TEST DEFINITION Interpretation

NOTE: Double check

interpretation

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.

that the COV calculations and

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

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

Check Strips can also be used to verify linearity.

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

Calibration and Linearity (Continued)

Place the instrument in the original packaging material.

functional tests be performed as if setting up the instrument for the first time.

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.



When returning the instrument to service from storage, it is recommended that

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

4. Troubleshooting

while calculating the concentration.

the maximum readable absorbance for the device.

negative absorbances!”

absorbance.

Edited!”

flag set to prevent it from being edited.

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

“>3” Prints in ABS column if a read absorbance is greater than

“%Absorbance Mode

should not be used with

“Assay Cannot Be

“Cannot match test

wavelength with filters currently installed on device!”

“Do not select the same filter for primary and differential”

This message will display if the user is in %Absorbance Mode and a standard is read which has a negative

User has tried to edit an OEM preprogrammed test that has

Pop up message that appears when running a test; occurs if the device cannot find filters for the wavelengths set in the test definition.

Appears on Page 1 of Test Definition when the same wavelengths are entered for the Primary and the Differential filters.

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

Messages and Flags (continued)

and < value NEG cutoff.)

Regression; minimum 4 for Cubic Spline).

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

“Factory Settings Restored”

“User Settings Restored “

“Invalid Curve!” This message indicates that readings for standards

“Invalid Curve – Log Error” An error in the creation of a curve or readings of a

”log(<=0)” Prints in Interpretation column whenever a curve axis

“LOW”, “HIGH” Prints in Interpretation column whenever a value is

“NEG” Negative – prints if a Sample is <NEG value (or if

“OUT” Blank is outside min/max range or sample is outside

“POS” Sample is >= POS value (or if reversed, sample is

One of these messages can be triggered when the operator chooses to restore parameters or could be seen at startup if the unit is forced to recover from bad settings.

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

negative absorbance will result in this message, followed by Test Ended.

mode with a log tries to log a zero or negative number.

lower or higher than the range of values entered to create the test.

reversed, sample is >NEG value).

low/high valid range values. Also appears in Cubic Spline mode when the sample is outside of the range of valid standards.

<=POS value.

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

Messages and Flags (continued)

increasing concentration.

Message/Flag Explanation

“Pos must be greater than or equal to Neg!”

“Range Error” This indicates there is a limit to the range of numbers

“>Ref” Prints when a sample exceeds the absorbance of the

Test Data Corrupted!

Test Definition Corrupted!

“Unable to assign control!” This message refers to control location in the test

“When reversed, Pos must be less than Neg!”“POS”

“Wrong date format (mm.yyyy)!”

This message appears during test definition when the 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.

that can be entered

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

Test (assay) Data (including calibration data) does not match what was stored.

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.

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.

Pop up message that appears during test definition 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.

This message indicates the expiration date for a control is not entered in the correct format

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

4.2 Error Messages

Open the Utility menu and select Print Unit Settings. power-off, wait, power-on"

Contact Technical Support

a plate to see

Indicates a problem was encountered and the

This indicates the instrument is not able to store assay

Contact Technical Support

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

Provide this information to Technical Support.

Error 109 “Air Values Too Dark”

“201, Read/Plate: Aborted, Plate Movement Error”

"i2c Bus error, 0x%02x. Unit may need service. Try

“Calibration Checksum Faulty”

Although anything that blocks the path of the light to the photometer can cause this, a burned out lamp is usually the cause.

If an error occurs during plate movement or during running a test, message will display and terminate the test. Contact Technical Support for assistance.

If restarting the instrument does not clear this message, contact technical support.

“Check unit Calibration”

“Check Calibration”

“Default Settings Loaded”

“Error Saving Assay Data!”

“Factory Data Not Saved”

Factory Settings Invalid

Go to the "Utilities" menu

Run "Recall 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 the message has been eliminated

If the message still appears, contact Technical Support.

instrument’s settings have been returned to the same status as when instrument was shipped from the factory.

information into memory. If less than 120 assays have already been stored, contact technical support.

User Settings Invalid

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

Error Messages (continued)

Technical Support for a passcode.

Updating internal firmware

If the system finds an older version of FTDI firmware,

Error Message

FTDI initialization error

===========================

Hardware Init Error (#10)

5. References

Description

This message will be seen if the FTDI startup initialization fails, tries again, but then fails a second time.

=======================================

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

this message will be displayed and the update will happen automatically. Do not turn off the unit until the update is complete

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

2. Data on DRI-DYE Florida (1989 to current date)

Check Strips, provided by Awareness Technology, Inc. Palm City,

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 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%.

Check Strips, along with good record keeping, will constitute

• 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

Check Strips-450 - for 450nm

Check Strips-492 - for 492nm

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

7. Information

Awareness Technology, Inc.

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:

1935 SW Martin Highway

Palm City FL 34990 USA

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

4200 in

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

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

look for the appropriate driver this one time.

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

Adjustment

Touch Pad Align

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.

Please carefully use a stylus to touch each of the 8 small squares on the edges to help adjust the touchpad ranges. Touch as closely

square

to the outside for best results. If the points are not close enough (3 points apart), some pairs may be reset.

edge of the screen as possible

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

Awareness Technology Stat Fax 4200 Operator's Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

1. Introduction

1.1 Applications

1.1.1 Intended Use

1.1.2 Summary of the Instrument

1.1.3 Principles of Operation

1.2 Warning Markings Inscriptions d’avertissement

1.2.1 Safety Symbols Le Symboles de Sûreté

1.2.2 Safety Terms Terminologie de Sûreté

1.3 Safety Precautions

1.3.1 Disposal

1.4 Specifications

1.5 Installation

1.5.1 General

1.5.2 Installation/Preparation

1.5.3 Load Paper

1.5.4 Touch Screen Description

1.6 Parts and Controls

1.7 Checkout Procedure

2. Operating Procedures

2.1 Operating Precautions

2.2 General Selections

2.3 Main Display Menu Options

2.3.1 Run Test

2.3.2 Settings

2.3.2.1 External Output

2.3.2.2 USB Mouse Connection

2.3.3 Manage Tests

2.3.3.1 Multi-Test

2.4 General Operation

2.4.1 Bichromatic Differential Operation

2.4.2 Loading and Formatting a Plate

2.4.2.1 Locating Controls

2.4.3 Reading a Plate

2.4.4 Unit of Measurement Codes (Unit Code)

2.4.5 Offset Absorbance

2.4.6 Lamp Saver and Lamp Warmup

2.5 Modes of Operation

2.5.1 Absorbance Mode

2.5.1.1 Filter Selection

2.5.1.2 Blank

2.5.2 Factor Mode

2.5.3 Single Standard Mode

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

2.5.4.1 - % Absorbance

2.5.4.2 – Editing a Curve

2.5.4.3 – Select Axes

2.5.4.4 – Controls

2.5.5 Cut Off Mode

3. Cleaning and Maintenance

3.1 Cleaning

3.1.1 Exterior

3.2 Maintenance

3.2.1 Calibration and Linearity

3.2.2 Storage

4. Troubleshooting

4.1 Messages and Flags

4.2 Error Messages

5. References

6. Optional Accessories

6.1 Thermal Printer Paper

6.2 Dri-Dye® Check Strips

7. Information

9. Appendix B Updating Firmware

10. Appendix C Touchpad Alignment