Awareness Technology Stat Fax 4700 Operator's Manual

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Stat Fax 4700

MICROSTRIP READER

OPPEE

RAATT

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MAA

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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

1.4 Specifications ........................................................................................................................... 6

1.5 Installation ................................................................................................................................ 8

1.5.1 General .............................................................................................................................. 8

1.5.2 Installation/Preparation...................................................................................................... 9

1.5.3 Touch Screen Description ............................................................................................... 10

1.5.4 Load Paper ...................................................................................................................... 11

1.6 Parts and Controls ................................................................................................................. 12

1.6.1 Strip Carrier Loading and Positioning ............................................................................. 13

1.6.2 Auto-Track ....................................................................................................................... 14

1.7 Checkout Procedure .............................................................................................................. 17

2. Operating Procedures ................................................................................... 18

2.1 Operating Precautions ........................................................................................................... 18

2.2 General Selections ................................................................................................................. 18

2.3 Main Display Menu Options ................................................................................................... 19

2.3.1 Run Test .......................................................................................................................... 20

2.3.2 Settings ........................................................................................................................... 21

2.3.2.1 External Output ....................................................................................................... 22

2.3.2.2 Mouse Connection .................................................................................................. 22

2.3.3 Manage Tests .................................................................................................................. 23

2.3.4 Utilities ............................................................................................................................. 24

2.4 General Operation ................................................................................................................. 25

2.4.1 Bichromatic Differential Operation .................................................................................. 25

2.4.2 Unit of Measurement Codes (Unit Code) ........................................................................ 26

2.5 Modes of Operation ............................................................................................................... 27

2.5.1 Absorbance Mode ........................................................................................................... 29

2.5.1.1 Filter Selection ........................................................................................................ 29

2.5.1.2 Offset Absorbance .................................................................................................. 30

2.5.1.3 Blank ....................................................................................................................... 30

2.5.1.4 Lamp Saver ............................................................................................................ 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

2.5.5 Cut Off Mode ................................................................................................................... 42

3. Cleaning and Maintenance ............................................................................ 48

3.1 Cleaning ................................................................................................................................. 48

3.1.1 Exterior ............................................................................................................................ 48

3.2 Maintenance........................................................................................................................... 48

3.2.1 Calibration and Linearity.................................................................................................. 48

3.2.2 Storage ............................................................................................................................ 49

4. Troubleshooting ............................................................................................. 50

4.1 Messages and Flags .............................................................................................................. 50

4.2 Error Messages ...................................................................................................................... 53

5. References...................................................................................................... 55

6. Optional Accessories .................................................................................... 55

6.1 Thermal Printer Paper ............................................................................................................ 55

6.2 Dri-Dye® Check Strips ........................................................................................................... 55

7. Information ..................................................................................................... 56

8. Appendix A – SF_Capture ............................................................................. 57

9. Appendix B - Installing new software .......................................................... 58

10. Appendix C – Touchpad Alignment ........................................................... 58

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 microtiter strips or break apart wells.

The Stat Fax open system with selectable strip formatting, alphanumeric test naming, automatic interpretation options, duplicate well options, curve plotting and editing, and flags and error messages.

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 in this manual is not sufficient.

1.1.2 Summary of the Instrument

The Stat Fax is also capable of monochromatic reading using four standard filters (405, 450, 492, and 630 nm) Special models are available with either six VIS (405, 450, 492, 545, 600, and 630 nm) or six UV (340, 405, 450, 492, 545, and 630 nm). Alternate filters are available from 340 to 700 nm.

4700 is a compact, microprocessor-controlled, multi-purpose photometer

4700 may be used for in-vitro diagnostic testing. It is a user-programmable

FOR IN-VITRO DIAGNOSTIC USE

POUR L'USAGE DIAGNOSTIQUE IN VITRO

4700 is specifically designed for bichromatic absorbance reading, however it

This instrument is programmed with many keypad-selectable general purpose programs. Each mode is self-prompting, to reduce error and simplify operation. The general purpose programs include relative light unit, multi-point linear and log-logit regressions, and point-topoint connections.

These calculation modes have been selected to facilitate the performance of Elisa immunoassays.

Convenience features include automatic blanking options, the ability to indicate the locations of positive and negative controls, and to enter control acceptance criteria for automatic comparisons, to select positive and negative interpretations based on concentration value, and to edit out discrepant duplicates with automatic re-calculation. In addition, userprogrammable memory allows the operator to store test protocols, recall tests by number, and delete unwanted tests from a user-generated test menu. Instructions for each of these modes and convenience features are provided in this manual.

Besides quick, accurate, and reproducible results, the instrument offers maintenance-free and easy operation, versatility, and economy. A stable, factory-calibrated durable design assures the reliability of the instrument.

Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G 1

Summary of the Instrument (Continued)

The Auto-Track feature enables all three strips to be read automatically, rather than having to read each strip individually. The Stat Fax

4700 uses a specialized strip carrier. Be sure

to use only this carrier. Starting from Position A (home position), the Auto-track feature transports the carrier such that all of the wells in all strips in the carrier are read; user is prompted to place the carrier into position by changing the background color and emitting a sound.

• Features

Store up to 120 tests Starting from the home position, the Auto-track feature transports the carrier such that all of the wells in all strips in the carrier are read; sounds and colorful displays guide the user. Transmit and capture data via USB to PC connectivity using SF_Capture

software (see External Output section).

 Pre-programmed Modes

In addition to reading absorbance, this instrument can be programmed to calculate concentrations based on stored formulas using absorbance readings of one or more calibrators. 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: Single point calibration by standard or factor, multi-point calibration with point-to-point curve fit, linear regressions with log, linear, and log-logit selections, cubic spline and cutoff mode selections.

 User-programmable Memory

The instrument’s software allows the operator to create, edit and store a menu of assay programs. 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 strip carrier precisely positions each well into the optical path for reading. Light energy from a lamp is focused by an integral lens, directed through an aperture, and then passed vertically through the sample. A wheel below the sample positions the filters so that readings can be taken very quickly at both the operating and differential wavelengths. (Using bichromatic differential absorbance values improves precision by correcting for optical imperfections in the plastic wells and removes the effects of meniscus and turbidity.) A photo detector converts transmitted light energy into electrical signals, which are amplified and interpreted.

2 Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G

1.2 Warning Markings Inscriptions d’avertissement

Risk of Shock

Risque de Choc

(Earth) Terminal

Prise de Terre

Refer to Manual

Se Rapportent a Manuel

Risk of Infection

Risque d’infection

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

DANGER”

CAUTION statements identify conditions or practices that could result

autre propriété.

BIOHAZARDS are biological agents that can cause disease in

agents.

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

Protective Ground

La Terre Electrique

1.2.2 Safety Terms Terminologie de Sûreté

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

DANGER

DANGER Le “de marque:

WARNING

AVERTISSEMENT! Le “de

marque: WARNING”

CAUTION

L’ATTENTION “Le de marque: CAUTION”

Indicates an injury immediately accessible as you read this marking

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.

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

CAUTION

L’ATTENTION

BIOHAZARD

Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G 3

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

1.3 Safety Precautions

below.

Refer any questions to your instrument service provider.

so may void the warranty.

this instrument.

Instructions

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

the country of use.

making connections to the instrument.

be free of vibrations.

(1/2”).

Do Not Operate Without Protective Covers

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

Avoid Exposed Circuitry

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

Avoid Excessive Dust

Do not operate in an area with excessive dust.

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

Wear Protective Apparel Many diagnostic assays utilize materials that are potential biohazards.

WARNING: Always wear protective apparel and eye protection while using

Follow Operating

Use Proper Power Cord WARNING: Use only the power cord specified for this product and certified for

Observe All Terminal Ratings

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

Provide Proper Ventilation

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

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 5 lbs (2.3kg). 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 clearances: 8cm (3”) around perimeter of unit, 8cm on top, and 1.27cm bottom

4 Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G

Wet/Damp Conditions

Safety Precautions (Continued)

Do Not Operate With Suspected Failures

Do Not Operate in

WARNING: If you suspect there is damage to this instrument, have it inspected by a qualified service person.

WARNING: Do not operate instrument 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

Keep Instrument Surfaces Clean and Dry

WARNING: Do not operate instrument in an explosive atmosphere.

within their acceptable limits, disregard test results.

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

CAUTION! L’ATTENTION!

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

Avertissement! Lors du fonctionnement, si on renverse des matériaux, coupez immédiatement le courant. Placez le commutateur électrique a AU LOIN(0). Traitez le matériel comme biohazardous, utilisant approprie nettoient et des méthodes de disposition.

Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G 5

1.4 Specifications

Photometric

Linear Measurement Range: ............ 0.00 to 3.0 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 bichromatic

Light Source: .................................... Tungsten-Xenon lamp with lamp saver feature

Standard Wavelengths: .................... Standard: 405, 450, 492, and 630nm Six Filter VIS: 405,

450, 492, 545, 600, and 630nm.Six Filter UV: 340, 405, 450, 492, 545, and 630nm

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

Carrier Format: ................................. Strip carrier can hold three break apart 12-well strips or

three 8-well

Vessel: ............................................ Single, or break apart and non-break apart strips up to 12

wells long, 3 strip loading capacity. 1 – 36 well loading capacity. User can select Number of Samples to be read

non-break apart strips.

Electronic

Display: ............................................. Interactive touch screen 3.5” (8cm) LCD, color graphic

display

Printer: .............................................. Thermal with graphic capability, approximately 29

characters per line

Power Requirements: ....................... 100-240 VAC, 1.2 A MAX universal input (no user

replaceable fuse)

Microprocessor: ................................ 50MHz eZ80, 64K EEPROM

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

Interface Options .............................. USB mouse; USB port used for thumb drive interface for

firmware updates (mouse not included). PC connectivity via SF_Capture software and USB cable (cable not included)

Software

Speed: .............................................. Reads, calculates and prints results, 30 seconds per 12-

well strip

included; thumb drive not

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Calculation Modes: ........................... Single point calibration by standard or factor, multi-point

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.

calibration with point-to-point curve fit, linear regressions with log, linear, and log-logit selections, cubic spline and cut off mode selections

Test Storage: .................................... Total of 120 open channels to store tests. Stores all

parameters including wavelengths, calculations, unit codes, ranges, interpretations, calibrator values, test names, and previous curve

Other

Enclosure: ......................................... Flame-retardant ABS plastic cover and base

Dimensions: ...................................... Approximately 9”x13”x5” (24x34x13cm) weight: 5 lbs

(2.3kg)

Certifications: .................................... CE, ETL listed, NRTL listed (USA/CAN)

Recommended Environmental Condition:

Indoor Use Mains supply voltage: Fluctuations not to exceed ±10% of the nominal

voltage Operating Temperature: 18-35°C recommended Operating Humidity: Less than 85% recommended Storage Temperature: 10 to 50°C

Accessories sold separately: ............... Thermal paper (contact your dealer)

Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G 7

1.5 Installation

QTY

PART

NO.

DESCRIPTION

QTY

PART

NO.

DESCRIPTION

47XX

Microstrip Reader

*Spare Parts Kit

993085

8-Way Carrier

150006

Printer Paper

993086

12-Way Carrier

112007

Lamp 6V 1amp (Prepared)

US or Euro Power Cord

OM4700

Operator’s Manual

004245

Stylus Pen Clip

47010

*Spare Parts Kit

954715

Lamp Replacement Instructions

1 Declaration of Conformity

Certificate of Quality

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. The operator’s manual, stylus, thermal printer paper, power supply module, and a spare parts kit will be packed with the instrument. Please locate each item now before continuing.

Packing List

101245 or 101246

1 004245 Stylus Pen

8 Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G

Instrument Placement

Place the instrument on a flat working surface capable of safely

Assure Clean Power

The circuit used should be substantially free of large voltage

Power Switch Position

The ON/OFF switch is on the back of the instrument. The power

Power Cord

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

1.5.2 Installation/Preparation

and Use

Availability

Requirements

supporting the weight of the instrument, approximately 2.3kg (5 lbs.). A clearance of at least 8cm (3”) around the instrument is required to assure optimal ventilation.

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

switch should be in the OFF position (down) before connecting the power cord to the power supply.

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.

Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G 9

1.5.3 Touch Screen Description

The Stat Fax 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

Excessive pressure can damage the touch screen. Use of the stylus provided is recommended for easy, accurate use and long life of the touch screen.

4700 touch screen responds to touch pressure which causes electrical contact

10 Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G

1.5.4 Load Paper

Locate the roll of thermal printer paper P/N 150006.

Lift the printer paper compartment lid at the tab location to open.

Caution: Be gentle lifting the latch on the printer. Once it is slightly open, release the latch and lift it from the sides of the lid

Figure 1.5.4-1 Paper compartment lid

location

Insert finger and lift tab to open lid. Place the paper roll in the well (A) such that the leading edge of the paper feeds upward from the front of the printer from the bottom of the paper roll.

Pull up at least 1 inch of paper and then press the compartment cover down until it snaps closed. Turn the power switch ON and the wake up

Figure 1.5.4-2 Printer paper

compartment lid open

routine will follow. Sounds will play during the brief initialization process. 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 150006 to reduce lint and extend printer life. Contact your dealer for replacement rolls.

Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G 11

1.6 Parts and Controls

The following terms are used in this manual to describe parts and controls of the Stat Fax® 4700

Carrier Track

Printer and

Touch Screen

Alignment

Power supply F

Power switch

Power

USB Type B

USB Type A

Stylus

E F G H I

Lead Pin Groove for Carrier Bar

Well Position A1

A C B

Microstrip Reader. More details on the operation of each feature are provided in Section 2Operating Procedures.

Printer Paper Compartment

Display

Arrow

Figure 1.6-2 Alignment

arrow

Figure 1.6-1 Front view

Figure 1.6-3 Carrier designed for non-break apart wells

module

connection

port

port: mouse and thumb drive

12 Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G

Figure 1.6-4 Back of instrument

1.6.1 Strip Carrier Loading and Positioning

Groove

Right

Front

Left

Groove for Carrier

Well Position A1

Lead Pin

The Strip Format must be selected before programming a new assay. Use the instructions from the table that follows to set the strip format, load, and properly position the strip carrier into the instrument. Place the carrier in the instrument as instructed; for proper alignment utilize the alignment arrow located inside the cover of the instrument (Figure 1.6.1-2).

Figure 1.6.1-1 Strip Carrier

To format an 8 well (A-H) or 12 well strip type: from the Settings menu, select the ‘Strip Format’ option. 8 and 12 well strip types will display. Make a selection and press Save. The printer will print out the enabled strip format.

Ensure that the wells are pushed down and seated firmly into the tray so that they will not cause the plate to jam on entry. Use care that well tabs do not extend over other wells. Use caution when attaching labels so they do not jam in reader or interfere with read path. Be sure to place the tabbed strip ends at the back of the carrier, well position 8 or 12.

Before installing the strip carrier, note the location of the lead pin and groove on the carrier; note the location of the alignment arrow inside the cover of the instrument (Figure 1.6.1-2).

WARNING: To prevent sample misidentification, use care when placing strips and wells into the strip carrier. Ensure the strips are not reversed so that the last patient ID is not read first. Wells are read in the direction in which they are loaded.

Front

bar

Figure 1.6.1-2 Strip Carrier with Well A1 in

position

CAUTION: Place the end of the strip carrier with the lead pin into the instrument first and place the groove over the groove bar. Slide the carrier into position all the way to left side so that position A1 on the strip is aligned with the instrument’s alignment arrow (Figure 1.6.1-2).

Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G 13

Strip Carrier Loading and Positioning (Continued)

Place the plate into

UNLOAD

QUIT

START

Select and confirm a stored test, or create a new test. The display will show the strip carrier, indicating where Blanks, Standards and Controls are located.

Two carriers are supplied with the instrument. The one without posts is for use with 3 strip, non-break apart wells configuration. (Refer to Figure 1.6-3.)

If fewer than three strips are to be read, select the #Samples button.

Once the wells have been read, (Accept, followed by OK), absorbance readings will be on the display for each well. The message “Press CONTINUE for Next Carrier” will appear. The user can choose whether or not to read more samples, using the same standard curve or calibration.

1.6.2 Auto-Track

The Auto-Track feature enables all three strips to be read automatically, rather than having to read each strip individually. The Auto-Track feature uses a specialized strip carrier (see Section 1.6.1 Strip Carrier Loading and Positioning). Be sure to use only approved carriers

the instrument with well A-1 at the right rear so that row 1 is going into the reader first.

14 Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G

Figure 1.6.2-1 Well Strip

Auto Track (continued)

C B A

3 4 5 6 7

START

UNLOAD

QUIT

The carrier must always be placed in the left-most position, so that A1 is the first well to be read.

• The footprint for most 8 and 12 well, single and break apart strips are similar and non-break apart strips will fit the Auto Track carrier. Be sure that all wells are seated firmly and evenly.

• 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 the carrier so they do not jam in the reader or interfere with the read path.

• Auto Eject feature - The software provides a “Load” and “Unload” option that will appear on the Main Screen. These options move the carrier bar in for reading, and out for ease of removing the strip carrier.

• Next, enter the number of samples, and then press ‘Accept’. A layout of the strip will display and prompt:

Set carrier to first strip, press START

Figure 1.6.2-2 On Screen Layout

Choose from the following options when prompted:

Option: Function:

Start The reader will begin to read the strip once ‘START’ is pressed.

Unload Extends the carrier out for ease of removal.

Quit Returns the user to the Main Menu.

Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G 15

If more wells/strips are to be read following the first selection, two additional buttons are

1 2 3 4 5

UNLOAD

REPEAT

QUIT

CONTINUE

added to the display - ‘CONTINUE’ and ‘REPEAT’.

Figure 1.6.2-3 Options to Continue or to Repeat

Choose from the following options when prompted:

Option: Function:

Continue

Repeat

If more wells/strips are to be read following the first selection, “Continue” will allow the user to select additional numbers of Samples to be read.

This allows the user to reread blank(s), standards, any controls and any samples over again without having to restart the test.

16 Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G

1.7 Checkout Procedure

Checkout Procedure

Visually confirm the following items:

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

Power switch is set to OFF.

The instrument is now ready for power-up. Confirm that the instrument responds as Set the power switch on the instrument to the ON position.

Loading …

Stat Fax 4700-1001

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

described.

The power up screen will display (Figure 1.7-1).

The instrument will play its “wakeup” sound track when powered on. The Stat Fax® 4700 logo will display as the program loads.

The printer will print the instrument model and 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).

Caution: Run the carrier empty at least once to verify mechanical parts before reading a real strip. (Refer to Section 1.6.1)

If the instrument produces results other than those described here, set the power switch to OFF. Refer to Section 1.5 Installation and review all steps carefully. If the instrument still produces results other than those described here, refer to Section 4. Troubleshooting, or contact your distributor for assistance.

Stat Fax

Figure 1.7-1 Power up Screen Display

Ver: Eng-00.44.00

Serial Number: 1234

Laboratory Name (if defined)

03-11-2018 11:23:56

Representation of power up print out

4700

Figure 1.7-2

Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G 17

2. Operating Procedures

CAUTION! Verify mode selection matches with the test kit package insert

2.1 Operating Precautions

• Avoid lifting, leaning or turning the instrument over when a strip carrier 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

or manufacturer’s instructions before reporting test results! Always include normal and abnormal controls.

CAUTION! L’ATTENTION!

2.2 General Selections

Every test requires a mode selection and filter combination. Thereafter, only those options pertaining to the mode selected will be asked. In the Absorbance Mode, for example, there are no further selections required, although additional options are provided. Review the following questions before beginning a test (refer to the reagent kit insert or kit manufacturer for required information):

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

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

3. How many calibrators will be used? NOTE: For the purpose of this manual, the terms

calibrator and standard are used interchangeably to designate reference materials of known concentrations.

4. What is the calibrator value or values?

5. Will calibrators and /or specimens be read in duplicate, or singly? NOTE: For the purpose

of this manual, the terms specimen and sample are used interchangeably to mean materials of unknown concentrations.

6. Will locations of one or more controls be marked? Controls are automatically placed in the

location of the first empty well following Blank(s) and or Standards.

7. Will acceptance cutoffs or ranges for controls be entered for automatic comparison? If so,

what cutoffs or ranges are to be used for each?

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

positive range will be required.

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

results less than which cutoff should be labeled as negative?

10. Will only partial strips be read?

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2.3 Main Display Menu Options

Lamp status

Time

Reprint button

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

• Load - the reader positions the carrier in the Home position.

• Unload - the reader positions the carrier for ease of removal.

indicator

Figure 2.3-1 Representation of the Main 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® 4700 Operator’s Manual Doc. 4700 Rev. G 19

2.3.1 Run Test

1 – T3

2 – T4

3 - TSH

4 – TFSH/FSH

5 – T3-Uptake

6 – LH/LH

7 - PRL

8 - hCG

9 - Digoxin

By #

Allows the user to enter a specific test number to recall.

Cancel

Returns to the main power on display screen

By #

Cancel

Select

SAMPLE

Select Test to RUN

The Run Test feature allows the operator to recall user tests that have been stored in the instrument’s memory. The instrument 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. If no assays have been programmed yet, the instrument will open to the Create Test screen automatically (see Section 2.3.3 Manage Tests). Otherwise, tests programmed and saved on the instrument will display sorted by their test number. 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 Sample - User Stored Tests

Feature Function

Arrows Use the ^ UP and V DOWN arrow keys to highlight selection; use the

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

Select The highlighted test is executed once the Select key is pressed

20 Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G

2.3.2 Settings

Printer Setup

Enables/disables the internal printer. Allows the contrast to be adjusted

Adjust Date

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

Lamp

Lamp idle feature will automatically turn off the lamp; the default setting is

seconds (45 seconds is the default setting).

Laboratory

Allows a laboratory named to be entered; laboratory name will print out

Strip Format

Allows the user to select 8 Well (A-H) or 12 Well (1-12) format. Note: Test

Strip Carrier Loading and Positioning).

Sound

Provides access to and status of touch screen sound settings (ON or

External

Allows external output to be turned ON or OFF. (Reference the External

Arrow Keys: Utilize the arrow

Select

Done

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

Printer Setup

Adjust Date and Time

Lamp Control

Laboratory Name

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

Strip Format

Select: The high-lighted

Sound Settings

option is executed once the Select key is pressed

External Output

Figure 2.3.2-1 Unit Settings

The functions of the Unit Settings features are:

Feature Function

light to dark. Text height options are small, medium and large.

Note Graphs can be printed when the internal printer is set to OFF.

and Time

Control

Name

Settings

Output

Note: It is advisable to print at contrast level set at 3. Higher contrast levels may degrade after several lengthy printouts.

as Month, Day, Year (MM/DD/YY) or Day, Month, Year (DD/MM/YY) format.

600 seconds (10 minutes). Lamp Warm up range is between 45 to 120

(reference Checkout Procedure in Section 1.7).

programs may be stored in either format but the strip format setting must be selected before programming a new assay. (Reference Section 1.6.1

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).

Output Section 2.3.2.1 for setup instructions).

Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G 21

2.3.2.1 External Output

To enable output to be sent to a personal computer, a user must have a USB cable with Type A and Type B end connections, and use a software application such as SF_Capture to transmit and store data from the instrument. (Refer to Section 8, Appendix B for SF_Capture software setup

• 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. (Cable is not supplied with instrument.)

Type A

Figure 1 USB Type A port and connector

Type B

Figure 2 USB Type B port and connector

2.3.2.2 Mouse Connection

To use a USB mouse with the Stat Fax 4700

, 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.

22 Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G

2.3.3 Manage Tests

Create Tes t

Edit Test Clone Test

Delete Test

Print Tes t List Exit

Create Test

Depending upon the mode, Create Test allows user to:

Edit Test

Used to change test programming. Editing a test will erase any stored blank or standard values for that test.

Clone Test

Delete Test

Provides option to delete a test from the user’s stored menu.”

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

Feature Function

CAUTION! To avoid confusion due to carry over of test settings, it is recommended that users save tests once they are created, or exit the Create Test option properly before accessing another mode. This ensures that the instrument’s memory has been cleared of all settings before creating the next test or performing the next operation.

• Name the test

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

to-Point, Regression, Cubic Spline, Cutoff)

• 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, number of replicates

• 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).

Allows user to duplicate an existing test; assigns the next available test slot number allowing for the test to be stored. The cloned test can then be edited. This feature provides a programming short cut when assays with similar programming are needed.

Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G 23

Manage Tests (Continued)

Change Access Level

Show Version Details

Erase All Tests

Recall Calibration

Print Unit Settings

Filter Voltages

Arrow Keys: Utilize the

Select

Done

Feature Function

Restore Tests (OEM models only)

User can choose to restore just one of the pre-programmed tests, or to restore all of the pre-programmed tests.

Print Test List Prints out the list of stored tests (maximum 120 tests)

Exit Returns to the Main display screen

2.3.4 Utilities

Select Utilities from the Main display screen and Utility Menu options used for diagnostic troubleshooting 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

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.

Done: Returns to the Main display screen.

Figure 2.3.4-1 Utility Menu options

Feature Function

Change Access Level Display prompts to ‘Enter Pass Code’. Contact Technical

Support for pass code.

Show Version Details Displays current firmware version, model, serial number, build

date, current time.

Erase All Tests “Please Confirm: Erase All Tests?”

CAUTION: Selecting ‘OK’ will delete ALL stored tests.

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

24 Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G

2.4 General Operation

2.4.1 Bichromatic Differential Operation

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

Whenever possible, differential reading is recommended because precision is significantly improved.

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

If no bichromatic wavelength is selected, exercise every measure to enhance repeatability such as checking that well bottoms are not wet, dirty or scratched. Use a blank in the assay to remove meniscus effect, and cover wells during incubation to prevent dust.

Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G 25

2.4.2 Unit of Measurement Codes (Unit Code)

Exit

Pos/Neg

Conc ^

1 v 1

Edit

Save Run

Decimals

# Sample Replicates

TEST DEFINITION Final page

Interpretation Mode

Units

SELECT UNITS

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. Check the container for the calibrator(s) to determine the units for results. Select the Units field and the list will display. Seven units of measurement designations are stored for labeling the concentration column heading on the printed results plus a blank customizable selection

Figure 2.4.2-1 Example – Interpretation Mode

Test Definition - Final page

Conc

IU/mL

g/dL

mmol/L

umol/L

ppm

ppb

Customize

Figure 2.4.2-2 Example –

Option to add a unit 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.

CAUTION: Be sure to use the same units for the calibrators, control criteria and interpretation criteria within a test.

26 Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G

lowest absorbance values.

2.5 Modes of Operation

Mode Function

Absorbance Section 2.5.1 - Absorbance mode reads and prints the monochromatic or

bichromatic differential absorbance at the user-selected wavelengths. Blanking is optional. Most Assays require a mode other than Absorbance Mode. In this mode, no calculations are made - only absorbance values are reported.

Factor 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

Point-toPoint

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.

Section 2.5.4 – The microstrip 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 line segments 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, 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 then compared to the absorbance of the calibrators. Its concentration is calculated on the segment connecting the closest points above and below it.

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

Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G 27

overshoot.

SELECT MODE

Absorbance

Cancel

Factor

Single Standard

Point to Point

Regression

Cubic Spline

Cut Off

Select

Regression Section 2.5.4 Regression mode accepts a number of calibrators and

calculates concentration values based on a best-fit curve (linear regression).

Cubic Spline Section 2.5.4 – Cubic Spline Mode accepts a minimum of 3 to 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 analyzer so that concentrations of unknown Samples are calculated from the generated curve. The resulting calibrator curve is a smooth curve connecting the Calibrator points, which may be entered in ascending or descending order of absorbance. A constraining algorithm is applied to prevent curve

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.

Figure 2.5-1Available Modes

28 Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G

2.5.1 Absorbance Mode

1st page Name Exit Mode

Primary Filter 405 v

Differential Filter 630

Blank YES Edit

Print Save >>

TEST DEFINITION

Absorbance

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. Press Manage Tests, press Create Test, and the Test Definition window will display.

Figure 2.5.1-1 Initial Test Definition display

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

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

Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G 29

2.5.1.2 Offset Absorbance

Name Exit Mode

Primary Filter 405 v

Differential Filter None

Blank NO Edit

Offset Absorbance 0.000

Print Save Run

TEST DEFINITION

Absorbance

Enabled YES v

# Replicates 1.0

Range Low Edit Range High Done

TEST DEFINITION Blank

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

Figure 2.5.1.2-1Test 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 100 µl 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.

2.5.1.3 Blank

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

30 Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G

Figure 2.5.1.3-1 Test Definition Blank display

2.5.1.4 Lamp Saver

Exit

Factor

Control 1

Control 3 Edit

<< Save Run >>

Disabled

TEST DEFINITION 2nd page

Disabled

Ten minutes after reading the last sample, the Lamp Idle Timeout feature will automatically turn off the lamp. 600 seconds (ten minutes) is the default setting. The Minimum Lamp Warmup will occur (45 seconds is the default setting), and then operation will resume where it left off. Refer to Settings to access the Lamp Control feature.

2.5.2 Factor Mode

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.

After pressing the advance arrows ‘>>’ in the first screen, the Test Definition second 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.

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.

Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G 31

Figure 2.5.2-1 Factor Mode Test Definition – 2

Page

Factor Mode (continued)

TEST DEFINITION Control 1

Enabled

YES

# Replicates 1

Name ^

Range Low v Range High

Action Edit

Lot Number Done

Expiration [mm.yyyy]

Location

Control 1

Warn, Co ntinue

Exit

Pos/Neg

Conc ^

1 v 1

Edit

<< Save Run Print

Units

Decimals

# Sample Replicates

TEST DEFINITION Final page

Interpretation Mo de

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.

Figure 2.5.2-2 Test Definition Control screen

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 2.4.2 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.

Figure 2.5.2-3 Factor Mode Test Definition - Final Page

“Decimals” refers to the number of places after the decimal point that will be displayed in a result. For example, a user has select that results should report out to 2 decimal places. The calculated result is 0.235. Rounding will result in this being reported as 0.24. If the calculated result is 0.234, the result will be reported as 0.23.

32 Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G

Factor Mode (Continued)

TEST DEFINITION Interpretation

Interpretation Pos/Neg ^

NO Edit

Done

Pos >=

Neg <

Reversed

Interpretation ^

Normal Range Low v

Normal Range High

Valid Range Low Edit

Valid Range High Done

TEST DEFINITION Interpretation

Normal

NOTE: Double check

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.

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.

that the interpretation information you entered is correct.

Figure 2.5.2-4 Factor Mode Test Definition –Pos/Neg Interpretation

Figure 2.5.2-5 Factor Mode Test Definition –Normal Interpretation

Press the Done button when editing is completed.

Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G 33

2.5.3 Single Standard Mode

1st page Name Exit Mode

Primary Filter 405 v

Differential Filter 630

Blank YES Edit

Print Save >>

TEST DEFINITION

Single Standard

Enabled

1.0 v

# Replicates

Range Low Edit Range High Done

TEST DEFINITION Blank

Figure 2.5.3-1 Single Standard Mode Test

Figure 2.5.3-2 Blank options

Exit

Standard Conc

# Std Replicates ^

Control 1

Control 2 v

Control 3 Edit

<< Save Run >>

Disabled

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.

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.

Definition – 1st Page

The Single Standard Mode Test Definition second 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.

Figure 2.5.3-3 Single Standard Mode Test Definition –2

34 Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G

Page

Single Standard Mode (Continued)

Enabled NO

# Replicates 1

Name ^

Range Low v Range High

Action Edit

Lot Number Done

Expiration [mm.yyyy]

Location

Control 1

Warn, Co ntinue

TEST DEFINITION Control 1

Exit

Pos/Neg

Conc ^

1 v 1

Edit

Save Run Print

Decimals

# Sample Replicates

TEST DEFINITION Final page

Interpretation Mo de

Units

TEST DEFINITION Interpretation

Interpretation Pos/Neg ^

NO Edit

Done

Pos >=

Neg <

Reversed

NOTE: Double check

is correct.

Figure 2.5.3-4 Test Definition Control screen

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.

Figure 2.5.3-5 Single Standard Mode Test Definition - Final Page

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.

Figure 2.5.3-6 Single Standard Mode Test Definition - Interpretation

Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G 35

that the interpretation information you entered

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

Absorbance

Cancel

Factor

Single Standard ^

Point to Point

Regression v

Cubic Spline

Cut Off Select

SELECT MODE

1st page Name Exit Mode

Primary Filter 405 v

Differential Filter 630

Blank NO Edit

Print Save >>

Point to Point

TEST DEFINITION

MULTI-POINT

The Stat Fax Cubic Spline.

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

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

The Test Definition first page displays the available options.

4700 offers three varieties of multi-point modes: Point-to-Point, Regression and

Figure 2.5.4-1 Select Mode

36 Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G

Figure 2.5.4-2 Point to Point Mode – 1

page

Multi-Point Modes (Continued)

% Absorbance

NO Exit

Standards 5

# 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

Standards

Exit

Number of Standards 3 ^

Std1 Concentration 10.0 v Std2 Concentration 20.0 Std3 Concentration 30.0 Edit

Done

The Test Definition second page will display and allow use of % Absorbance, editing of the number of Standards and to enable the use of Controls. Note: The number of Standards must be at least two for Point-to-Point and Regression. Cubic Spline mode requires at least three Standards.

The Test Definition second page options include use of % Absorbance, Standards, number of Standard Replicates, selection of Axes, and Controls.

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

Figure 2.5.4-3 Test Definition – 2

Page

% Absorbance assigns a value of 100% to the first Standard, which must be the Standard with the greatest absorbance. Then the % absorbance relative to the first Standard is calculated for each Standard and Sample, in addition to a concentration value. 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.

After entering or editing the number of standards, a dialog box will open prompting the user for a Yes or No response to ‘Off Curve OK?’ “Off Curve” allows the user to determine whether concentration results are reported when an absorbance is greater than or less than the Standards that make up the curve. Select ‘Yes’ to report the results that are ‘off curve’ otherwise select ‘No’.

Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G 37

Figure 2.5.4-4 Standards Test Definition Screen

Multi-Point Modes (Continued)

Dup#

Dupl 1

Dupl 2 1 X

Using Edited Curve

S1 = .789 Deleted

r=0.999

v=1.2077

Re-calculating……

Y = Logit(Abs) X = Log(Conc)

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

When Duplicate Standards are used, the curve may be edited by deleting one of a pair of standards. Once the curve has been read, before the ‘Accept’ or ‘Print’, select ‘Edit’. Using the stylus, select the duplicate standard to be deleted. As shown below, they are labeled as ‘Dupl I’ and ‘Dupl II’.

m=0.738

Figure 2.5.4-5 Duplicate Standards Screen

An “X” will appear in the location on the display that is to be deleted. The curve will be recalculated and the options to Accept, Edit, Print or Quit will be available.

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.

When using Regression mode, the standard curve, y-intercept (y), slope (m) and Correlation coefficient ® will be printed. Printing the graph is also optional.

SELECT AXES

Figure 2.5.4-6 Axis Selection Screen

38 Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G

Multi-Point Modes (Continued)

SELECT AXES

Cancel

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

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

Y=Abs X=Ln(Conc)

Y=Abs X=Conc

The program

Calculation Explanation

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

data (x) are linear.

“Y=Ln (1000*ABS), X=Conc” The natural log of the absorbance is plotted against

the concentration. The absorbance values are multiplied by 1000 before taking the logs.

“Y=ABS, X=Ln(Conc)” Absorbance is plotted against the natural log of the

concentration.

“Y= Ln (1000*ABS), X=Ln(Conc)” The natural log of the absorbance is plotted against

the natural log of the concentration.

“Y= Logit(Abs), X= Log(Conc)” Select to calculate unknowns using the equation:

Abs Logit = Ln [(sample/0 cal) / 1-(sample/0 cal)]

Refer carefully to the Reagent Kit product insert for correct selection.

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

For Point-to-Point and Regression modes, number of standards can be between two and eight. Cubic Spline mode requires at least three standards.

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..

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® 4700 Operator’s Manual Doc. 4700 Rev. G 39

Figure 2.5.4-7 Log/Logit Options

Multi-Point Modes (Continued)

TEST DEFINITION Control 1

Enabled YES

# Replicates 1

Name ^

Range Low v Range High

Action Edit

Lot Number Done

Expiration [mm.yyyy]

Location

Control 1

Warn, Co ntinue

Exit

Pos/Neg

Conc ^

Edit

<< Save Run Print

Units

Decimals

# Sample Replicates

TEST DEFINITION Final page

Interpretation Mo de

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

40 Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G

Figure 2.5.4-8 Test Definition Control screen

Figure 2.5.4-9 Test Definition – Final Page

Multi-Point Modes (Continued)

Interpretation ^

Normal Range Low v

Normal Range High

Valid Range Low Edit

Valid Range High

Done

TEST DEFINITION Interpretation

Normal

Interpretation ^

NO Edit

Done

Neg <

Reversed

TEST DEFINITION Interpretation

Pos/Neg

Pos >=

NOTE: Double check

is correct.

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

that the interpretation information you entered

2.5.4-10 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.

Figure 2.5.4-11 Test Definition – Normal Interpretation

Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G 41

2.5.5 Cut Off Mode

Absorbance Cancel

Factor

Single Standard ^

Point to Point

Regression v

Cubic Spline

Cut Off Select

SELECT MODE

1st

Primary Filter

405

Differential

Blank

Save

Figure 2.5.5-2 Sample of Cut Off Mode Test

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 cutoff 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

4700 employs a universal

equation that can be adapted to fit most commercially available kits by inserting user-entered factors ‘X’ and/or ‘Y’ as well as a coefficient ‘F’. The equation is (X)(mNC) + (Y)(mPC)+F = COV (Cut Off Value).

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

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

Figure 2.5.5-1 Initial Test Definition

display

TEST DEFINITION

Name

page

Exit

Mode Cut Off ^

Filter

630

Definition 1st page

42 Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G

Cut Off Mode (Continued)

COV= Exit

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

TEST DEFINITION Control 1

Enabled YES

# Replicates 1

Name ^

Range Low 0.2 v Range High 0.4

Action Edit

Lot Number Done

Expiration [mm.yyyy] 03.2016

Neg Ctrl

Warn, Co ntinue

122

The Cut Off Mode Test Definition first page displays the available options: Name, Mode (Cut Off), Primary Filter, Differential Filter, and Blank.

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

Figure 2.5.5-3 Sample of Cutoff 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, 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 editing fields.

Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G 43

Figure 2.5.5-4 Test Definition Control screen

Cut Off Mode (Continued)

X*mNC+Y*mPC+F

X*mNC+F

Y*mPC+F

X*mCC+F

Cancel

Select

See explanation

Note: When Cut Off Controls are read in multiples (replicates), the mean of the replicates can be calculated and that value used, or each Control can be required to fall within the ranges set. “Check Mean?” will display if replicate Controls are selected.

Selecting the ‘COV =’ field will open the Select COV Formula screen. In addition to the universal equation, Stat Fax

When COV is the Cut Off 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.

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

of choices in the table on the next page.

4700 offers three optional formulas.

Figure 2.5.5-5 Cut Off Formula Screen

44 Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G

Cut Off Mode (Continued)

X*mean(NC) + Y*mean(PC) + F

Universal equation, used to calculate the cut off value

X* mean(NC) + F

Use this equation if only negative controls are used to

Y * mean(PC) +F

Use this equation if only positive controls are used to

X*mean(CC) + F

COV = cut off value for positive or negative interpretation

COV Formula Explanation

based upon readings of positive and/or negative controls.

In this equation, NC and PC are used to determine the COV (cut off value).

Enter the variables provided in the package insert.

This will calculate the mean of the positives and the mean of the negatives.

determine the COV.

For interpretation, you may choose either the Regular Cut Off Mode (positive >= cutoff, negative < cutoff), or the Reverse Cut Off Mode. With the Reverse Cut Off option, the Samples with values lower than the cut off are labeled as “positive”. If you choose this option, be careful to follow the < and > signs in the prompts for entering cut offs and ranges.

Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G 45

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 cut off controls when test is run

Blanking is optional, dependent upon the Assay Kit

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

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

Cut Off Mode (Continued)

TEST DEFINITION Cutoff Quality

Minimum COV

Maximum COV

(mPC/mNC).=

(mPC-mNC).= Edit

Reversed

NO Done

Note: ‘Reversed’ field is ‘YES’ when low absorbances are positive and high absorbances are negative, ‘Blank’ is not subtracted.

Exit

Pos/Neg

Abs/COV ^

3 v 1

Edit

<< Save Run Print

TEST DEFINITION Final page

Interpretation Mo de

Decimals

# Sample Replicates

Units

TEST DEFINITION Interpretation

Interpretation Pos/Neg ^

Edit

Done

Pos >=

Neg <

Reversed

Figure 2.5.5-7 Cut Off Mode Test

Figure 2.5.5-8 Cut Off Mode Test

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

(mPC / mNC): Enter the lowest acceptable ratio for the mean of the positive controls to the mean of the negative controls

(mPC – mNC): Enter the lowest acceptable difference for the mean absorbance of the

Figure 2.5.5-6 Cut Off Mode – Quality

Criteria screen

If the Reversed field reads ‘YES’ the samples with values lower than the cutoff are labeled as positive. In addition, the Blank is not subtracted in the Reverse Cut Off 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.

positive controls minus the mean absorbance of the negative controls.

Definition - Final page

NOTE: Double check that the COV

calculations and interpretation information

you entered is correct.

Definition – Interpretation

46 Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G

Cut Off Mode (Continued)

Interpretation

Normal Range Low

Normal Range High

Valid Range Low

Edit

Valid Range High

Done

TEST DEFINITION Interpretation

Normal

Figure 2.5.5-9

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.

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

Press the Done button when finished editing.

Test Definition - Interpretation

Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G 47

3. Cleaning and Maintenance

3.1 Cleaning

3.1.1 Exterior

CAUTION: Solvents such as acetone or paint 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 also be used as a disinfectant. Take special care not to spill any liquid into the read well.

3.2 Maintenance

3.2.1 Calibration and Linearity

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

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

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

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

A reduction in linearity may be indicative of filter deterioration. In this event, filter replacement is required for continued reliable operation. A monthly verification of instrument linearity is generally required to comply with regulatory agencies.

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

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

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

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

48 Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G

Calibration and Linearity (Continued)

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

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:

• Place the instrument in the original packaging material.

Check Strips.

• When returning the instrument to service from storage, it is recommended that functional tests be performed as if setting up the instrument for the first time.

Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G 49

4. Troubleshooting

If the factory default settings, which include stored calibration,

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 (column only prints six characters maximum)

“******”

“>3” Prints in ABS column if an absorbance is greater than the

“%Absorbance Mode should not be used with negative absorbances!”

“Assay Cannot Be Edited!” User has tried to edit an OEM preprogrammed test that has

“Cannot match test wavelength with filters currently installed on device!

• 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.

• Will print if a curve with a log axis tries to log a zero, a negative number, or an invalid curve has been read.

• Prints in Concentration column whenever an error occurs while calculating the concentration.

maximum readable absorbance for the device.

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

flag set to prevent it from being edited.

Indicates that a filter has been changed and a test has been recalled that was stored before the filter change. Create and store a new test with the new filter(s).

“Carrier out of position” This message will be posted if the carrier is not loaded in the

correct beginning position, with A1 the first well to be read.

“Default settings loaded.”

do not load, then default parameters are used.

50 Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G

Differential filters.

Messages and Flags (Continued)

Message/Flag Explanation

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

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

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

and greater than the NEG cutoff concentration. (If it is reversed, then the sample is > value POS cutoff and < value NEG cutoff.)

“Factory Settings Restored””

“User Settings Restored “

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.

“Invalid Curve!” This message indicates that readings for standards cannot be

used to obtain a valid curve for the calculation mode being used. If duplicate standards are used, the user has the option to edit the curve if there are enough points (minimum 3 for Point-to-Point and Regression; minimum 4 for Cubic Spline).

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

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

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

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

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

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

“Mechanism Error”

“Mechanism Jam

Indicates that the mechanism is not receiving any updated position information from the sensors.

• Be sure you use the correct carrier.

• Check for incorrectly placed carrier and free the jam,

otherwise notify Technical Support

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

sample is >NEG value).

“Not enough wells selected to run assay as defined”

This indicates that the “# Wells” selected were too few to run the Blanks/Standards/Controls as defined in the test.

Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G 51

Messages and Flags (Continued)

Message/Flag Explanation

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

valid range values It also appears in Cubic Spline mode, when the sample is outside the range of valid standards

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

value.

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

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

>Ref Prints when a sample exceeds the absorbance of the

Test Data Corrupted!

Test Definition Corrupted!

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.

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 increasing concentration.

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.

“When reversed, pos must be less than neg!”

“Wrong date format (mm.yyyy)!”

52 Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G

If using both positive and negative interpretations during test definition, AND if the positive value is greater than the negative value, AND Reverse has been selected, this message will be posted.

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

"i2c Bus error, 0xNN. Unit

If restarting the instrument does not clear this message,

"BAD" next to a filter

This message will be posted if an assay was previously

“Calibration Checksum Faulty”

Contact Technical Support

“Check unit calibration”

In the event calibration has become corrupted. Recall

“Default settings loaded”

Retrieval of unit parameters changed since the instrument was “Error: Offset value out of

Offset value is not in the range of 20 – 250 – contact technical

Error Saving Assay Data!

This indicates the instrument is not able to store assay

4.2 Error Messages

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

Error Message Explanation

may need service. Try poweroff, wait, power-on"

“Check Calibration”

range”

“Factory Data Not Saved” Contact Technical Support

contact technical support.

programmed with a filter that is no longer in the instrument. Delete or Edit the filters. If this is not the problem, contact technical support.

Calibration from the Utility Menu can be used to restore the Factory Calibration.

first shipped from the factory could not be completed – the original factory unit parameters were restored.

support

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

“Factory Settings Invalid”

“User Settings Invalid “

“Home Sensor Malfunction” This occurs when the mechanism travels to the front and then

“Lamp/Filter Volts Low” This can indicate the use of a faulty or wrong type of carrier.

Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G 53

Contact Technical Support

travels back, searching for home, and finds that it has gone too far. Contact technical support.

If the error message appears when the instrument is turned on, but before attempting to read a strip, be sure that the light is on. If not, check the voltage to the lamp and replace the lamp if necessary. If problem continues, contact Technical Support.

“Mechanism Error”

"Mechanism Timeout"

Indicates that the motor appears to be turning but no

Contact technical support.

“Updating internal firmware”

If the system finds an old version of FTDI firmware, flag

turn off the unit until the update is complete.

“Abnormal filter index cnt=x”

During startup, if the filter wheel index count does not get

Error Messages (Continued)

Error Message Explanation

“Mechanism Jam”

Indicates that the mechanism is not receiving any updated position information from the sensors.

Be sure to use the correct carrier. Check for badly placed carrier and free the jam. 3. Contact Technical Support.

response is received from the sensors.

message displays and it is updated automatically. Do not

“Please turn instrument off, pause, then back on. Call service if problem persists.”

Filter Wheel Error, cnt = “x”

FTDI initialization error

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

Hardware Init Error (#10)

“Wheel Speed out of range”

“Wheel not spinning properly” This message will be posted if the ‘Wheel Speed out of

3 consecutive readings that are either 4, 6, or 8, this error message will show on the display.

When starting an assay, if the filter count does not match the count determined at startup, this error message will show on the display. “x” = the last count.

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 Technical Support for a passcode.

This message indicates a change in filter wheel speed. This is usually temporary. If it becomes persistent it indicates a need for service.

range’ message is displayed more than 3 times.

“Wheel not spinning properly. Fix the issue and restart the unit' will be displayed and all screen functions will be disabled.

Check that filter wheel and filter wheel motor belts are properly installed. Check rotation of filter wheel motor, jack shaft and filter wheel for possible binding. Check that the filter wheel motor is plugged into its connector.

54 Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G

5. References

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,

6. Optional Accessories

6.1 Thermal Printer Paper

Reorder replacement Thermal Printer Paper Roll P/N 150006. NOTE: The printer manufacturer strongly recommends the use of thermal paper part number 150006 to ensure the best print quality and the effective operation of the print head. Contact your distributor for replacement rolls.

6.2 Dri-Dye® Check Strips

DRI-DYE

• 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 reader can repeatedly obtain acceptable results with this kit, then the instrument demonstrates linearity, calibration, filter integrity, repeatability, and lack of stray light.

• Proper use of the Dri-Dye® Check Strips, along with good record keeping, will constitute compliance with most quality control and licensing agency requirements for instrument performance verification.

CHECK STRIPS

• 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 pathlength, and hence, to absorbance. If a well is reconstituted with too much water, the decrease in concentration will be corrected by the increase in pathlength. Simply stated, the system is self-correcting for random pipetting errors up to 10%.

• DRI-DYE® Check Strips can be ordered from your dealer.

The charts provided with these kits are designed to replace the normal calculations with easy to visualize, built-in acceptance ranges. Kits are available for the following wavelengths:

o DRI-DYE® Check Strips-405 - for 405nm

o DRI-DYE® Check Strips-450 - for 450nm

o DRI-DYE® Check Strips-492 - for 492nm

Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G 55

7. Information

Awareness Technology, Inc.

In the unlikely event that a problem occurs with the instrument, please consult your Instrument supplier first. If you continue to have problems after consulting your instrument supplier, contact the factory.

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® 4700 in question. Have a description of the problem with as much detail as possible. Save any relevant jobs or logs and send or e-mail us the information.

Model:______________

Serial #___________

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.

56 Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G

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.

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

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

NOTE: An installation of drivers will need to be done the first time SF_Capture is installed on a PC.

Once the cable connection is made between the reader and the PC, Windows® will pop up a message box stating that the VNC1-A as Slave is not installed and that drivers will need to be found.

Correct response is to let Windows

look for the appropriate driver this one time.

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

The same window will open again. Windows

will search for and install USB Serial Port

driver(s).

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

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

Data is exported to both .xls and.txt files, and to a Log file each time QUIT/Test Ended occurs.

The default location for these files is C:\4700. This can be changed from the default by using the Browse option for the Device Root Folder.

Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G 57

9. Appendix B - Installing new software

Adjustment

Touch Pad Align

1. Erase/delete anything that is on the USB pen drive (or any USB drive).

2. If the software is received in a zip file, double click the zip file to see the romimage.47x folder. The romimage.47x folder will have 2 files inside of it. Do not remove them.

3. Copy and paste the folder “romimage.47x” on to the USB drive.

4. Turn off the instrument and insert the USB into the back of it.

5. Place a finger on the display and then power up the 4700.

6. After the instrument begins to beep you can remove your finger from the screen.

7. The update process will take about 3-5 minutes. 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

58 Stat Fax® 4700 Operator’s Manual Doc. 4700 Rev. G

Awareness Technology Stat Fax 4700 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

1.4 Specifications

1.5 Installation

1.5.1 General

1.5.2 Installation/Preparation

1.5.3 Touch Screen Description

1.5.4 Load Paper

1.6 Parts and Controls

1.6.1 Strip Carrier Loading and Positioning

1.6.2 Auto-Track

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 Mouse Connection

2.3.3 Manage Tests

2.3.4 Utilities

2.4 General Operation

2.4.1 Bichromatic Differential Operation

2.4.2 Unit of Measurement Codes (Unit Code)

2.5 Modes of Operation

2.5.1 Absorbance Mode

2.5.1.1 Filter Selection

2.5.1.2 Offset Absorbance

2.5.1.3 Blank

2.5.1.4 Lamp Saver

2.5.2 Factor Mode

2.5.3 Single Standard Mode

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

2.5.5 Cut Off Mode

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

8. Appendix A – SF_Capture

9. Appendix B - Installing new software

10. Appendix C – Touchpad Alignment