Stat Fax 4500

CHEMISTRY ANALYZER

OPERATORS MANUAL

Copyright 2009 Awareness Technology Inc. Doc. 4500 06/2009 Rev. C

 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 Specifications........................................................................................................................ 3
1.3 Warning Markings Inscriptions davertissement ............................................................... 5
1.3.1 Safety Symbols Le Symboles de Sret ......................................................................................... 5
1.3.2 Safety Terms Terminologie de Sret ........................................................................................... 5
1.4 Safety Precautions................................................................................................................ 7
1.5 Installation............................................................................................................................ 9
1.5.1 General .......................................................................................................................................... 9
1.5.2 Installation/Preparation.................................................................................................................. 9
1.5.3 Parts and Controls........................................................................................................................ 12
1.5.4 Touch Screen Description............................................................................................................ 13
1.6 Checkout Procedure .......................................................................................................... 14
2. Operating Procedures .................................................................................................. 16
2.1 Main Menu Display ........................................................................................................... 16
2.1.1 Run Test....................................................................................................................................... 16
2.1.2 Settings ........................................................................................................................................ 17
2.1.3 Manage Tests............................................................................................................................... 19
2.1.4 Utilities ........................................................................................................................................ 21
2.2 General Operation ............................................................................................................. 22
2.2.1 Bichromatic Differential Operation ............................................................................................. 22
2.2.2 Blanking ...................................................................................................................................... 22
2.2.3 Unit of Measurement Codes (Unit Code) .................................................................................... 23
2.3 Modes of Operation ........................................................................................................... 23
2.3.1 Kinetic [Rate] .............................................................................................................................. 24
2.3.2 Absorbance Mode........................................................................................................................ 26
2.3.3 Factor Mode................................................................................................................................. 28
2.3.4 Standard Mode............................................................................................................................. 31
2.3.5 Point to Point Mode..................................................................................................................... 34
2.3.6 Regression Mode ......................................................................................................................... 38
2.3.7 Cubic Spline Mode ...................................................................................................................... 41
3. Cleaning and Maintenance ......................................................................................... 45
3.1 Cleaning .............................................................................................................................. 45
3.1.1 Exterior ........................................................................................................................................ 45
3.1.2 Flowcell (Optional)...................................................................................................................... 45
3.1.3 Waste Bottle (Optional)............................................................................................................... 46
3.2 Maintenance ....................................................................................................................... 46
3.2.1 Calibration and Linearity............................................................................................................. 46
3.2.2 Storage......................................................................................................................................... 47
4. Troubleshooting ........................................................................................................... 48
4.1 Error Messages .................................................................................................................. 48
5. Optional Accessories .................................................................................................... 52
5.1 Flowcell (Optional) ............................................................................................................ 52
5.2 Thermal Printer Paper...................................................................................................... 53
5.3 REDI-CHECK Photometer QA Kit ............................................................................... 53
6. Contact Information .................................................................................................... 54
1. INTRODUCTION
1.1 Applications

1.1.1 Intended Use

The Chemistry Analyzer is a laboratory instrument intended for in-vitro diagnostic
use. It is a compact, microprocessor-controlled, bichromatic photometer system with
six filters and 37C incubation. The standard diameter for the round tubes used with
the instrument is 12mm. The instrument can be used to measure absorbances or
concentrations based on standard points or rates of change, as described in this
manual. This general purpose instrument is intended to be used by trained laboratory
professionals capable of selecting the appropriate features and options for each
specific clinical application.

1.1.2 Summary of the Instrument

The Stat Fax 4500 is a compact, standalone, Chemistry Analyzer. Its
streamlined design offers touch screen interface, superb optics, on-board curve-
fitting software, and a built-in printer to meet the requirements of modern
laboratories.

The Stat Fax 4500 Chemistry Analyzer is designed for the processing of
biochemistries, tube method immuno assays, and drug assays from human serum,
plasma, or urine. The instrument accepts standard 12 mm round tubes. The primary
function of Chemistry Analyzer is to read and calculate the results of both endpoint
and kinetic colorimetric assays. Any test procedure that calls for absorbance reading
at or near one of the available wavelengths can be performed with this instrument.
Additionally, the most commonly applied data reduction formulae are pre-
programmed to further facilitate laboratory testing. These programs include rate
calculation and single and multipoint standardization. Through the LCD touch screen
display, the instrument prompts the operator to read the tubes in the appropriate
sequence. It then performs the necessary calculations and prints out test results.

In addition to the six primary filter choices, the operator may select a differential
wavelength for bichromatic reading in any operating mode. This corrects for
imperfections in the test tubes and often removes the effects of unwanted turbidity.

Each mode of operation is self-prompting, to reduce error and simplify operation. In

all modes the instrument will reference air, request and read the blank tube, and then
read and print automatically whenever a tube is inserted. All modes may be read
kinetically.

The Stat Fax 4500 Chemistry Analyzer includes non-volatile memory, a

feature that allows test parameters and standard curves to be stored for rapid future
recall.

The Stat Fax 4500 Chemistry Analyzer also contains a 37C incubation
block with 12 stations. The incubator will accommodate 12 mm diameter round test
tubes (size may be specified at time of purchase). A similar self-monitoring
incubation system is built into the read well for temperature controlled absorbance
reading at 37C this is often essential to the precision of rate determinations.

Stat Fax 4500 Operators Manual Doc. 4500 Rev. C 1

 The Stat Fax 4500 offers quick, accurate, reproducible results; maintenance-
free, easy operation; versatility, and economy. The durable design of the instrument
includes many features to minimize operator error, such as stable factory calibration,
automatic zeroing, complete operator prompting, detailed labeling, pre-programmed
calculations, visual and audible feedback, and error messages.

User-friendly features such as an internal printer and a touch screen LCD display.
The timed lamp saver feature further assures the continuous reliability of the
Chemistry Analyzer (see Settings section for more information on Lamp Control).

The operating modes are:

Absorbance Mode
Reads monochromatic or bichromatic differential absorbances at user-
selected wavelengths.

Factor Mode
Reports concentrations by multiplying absorbance values by a specified
factor. Differential samples (against sample blanks) are supported.

Standard Mode
Reports concentrations based on a single standard concentration. Differential
samples (against sample blanks) are supported.

Point to Point Mode

The Stat Fax 4500 chemistry analyzer accepts a number of calibrators
and calculates concentrations based on the point-to-point calibration curve.

Kinetics [Rate] Mode

Reports concentrations either based on the average absorbance per
minute multiplied by a user supplied factor (Rate by Factor), or based on the
absorbance per minute of a standard (Rate by Standard). A fixed-time
kinetic mode calculates based on absorbance over a specified interval. The
Rate Mode includes a Batch option that permits kinetic assays to be run
simultaneously.

Regression Mode
Accepts a number of calibrators and calculates concentration values based
on a best fit curve.

Cubic Spline
Accepts a number of Calibrators and calculates concentrations based on the
Cubic Spline (Constrained) calibration curve. The resulting calibrator curve is
a smooth curve connecting the Calibrator points, which may be entered in
ascending or descending order of absorbance. A constraining algorithm is
applied to prevent curve overshoot based on a single standard concentration.
Differential samples (against sample blanks) are supported.

1.1.3 Principles of Operation

Light energy from the lamp is focused by a lens, directed through an aperture, and
then passed horizontally through the sample. A continuously rotating wheel positions
the filters so that readings can be taken very quickly at 2 wavelengths. (Using
bichromatic differential absorbance values corrects for optical imperfections in the
tubes.) A photo detector converts transmitted light energy into electrical signals,
which are amplified and interpreted.

2 Stat Fax 4500 Operators Manual Doc. 4500 Rev. C

1.2 Specifications
Photometric
Linear Measurement Range: .....................Tube or cuvette 0.00 to 3.0
Absorbance Units (A)
Photometric Accuracy:...............................+/- 1% of the reading + 0.005A
Stability: .....................................................Drift of no more than 0.005A in 8
hours/bichromatic
Light Source: .............................................Tungsten lamp with lamp saver
feature
Standard Wavelengths: .............................340, 405, 505, 545, 580, and 630nm
alternate filters available from 340 to
700nm
Filter Type:.................................................IAD hardcoat interference, 10nm half
bandpass
Tube Size: .................................................12mm round is standard
Minimum Sample Volume:.........................1mL for 12mm round tube

Electronic
Display:......................................................Interactive touch screen 3.5 LCD,
color graphic display
Printer: .......................................................Thermal dot matrix with graphic
capability
Power Requirements: ................................115V or 230V AC, 1.5A, 50-60Hz
(universal input)
Microprocessor: .........................................eZ80, 64K EEPROM
Memory:.....................................................768K bytes Flash Memory, 512K static
RAM Memory
Interface:....................................................USB mouse, USB 2.0 compatible

Software
Speed: .......................................................Reads, calculates and prints results, 3
seconds per tube
Calculation Modes: ....................................Absorbance, Factor, Standard, Point-
to-Point, Regression, Cubic Spline (all
modes kinetically)
Test Menu:.................................................Stores 99 tests. Stores all parameters
including wavelengths, calculations,
unit codes, linear and normal ranges,
rate timing, standard values, test
names, and previous standard curve.
Other
Temperature Control:.................................Read cell and incubation block, user
selectable (OFF/ON)
Enclosure:..................................................Flame-retardant ABS plastic cover
and base
Dimensions: ...............................................Approximately 9x13.5x5
(24x34x13cm) weight: 10 lbs (4.5kg)

Stat Fax 4500 Operators Manual Doc. 4500 Rev. C 3

 Environmental Conditions for Safe Operation
Indoor use
Altitude up to 2000m
Temperature 5C to 40C (Although it
may be safe to operate in these
conditions, it may not be suitable for
the performance of your tests; check
with your supplier.)
Humidity 80% for temperatures up to
31C, decreasing linearity to 50%
humidity at 40C Mains supply voltage
fluctuations not to exceed + 10% of
nominal voltage
Recommended Environmental Conditions
Recommended Operating Temperature ....18-35C
Recommended Operating Humidity:..........less than 80%

Design and instrument specifications are subject to change without notice.

4 Stat Fax 4500 Operators Manual Doc. 4500 Rev. C

1.3 Warning Markings Inscriptions davertissement

1.3.1 Safety Symbols Le Symboles de Sret

Safety symbols which may appear on the product:
Les symboles de sret peuvent apparaitre sur le produit:

WARNING Protective Ground CAUTION BIOHAZARD

AVERTISSEMENT La Terre Electrique LATTENTION BIOHAZARD
Risk of Shock (Earth) Terminal Refer to Manual Risk of Infection
Risque de Choc Prise de Terre Se Rapportent Risque dinfection
a Manuel

FUSE: For continued protection against the risk of fire, replace only with fuse of the
specified type and current ratings. Disconnect equipment from supply before replacing
fuse.

FUSIBLE: Pour la protection continue contre le risque du feu, remplacez le

fusible seulement par une du type spcifique et des estimations courantes.
Dmontez lquipement de lalimentation dnergie avant de remplacer le fusible.

1.3.2 Safety Terms Terminologie de Sret

These terms may appear on the product:

Les marques sur le produit:
DANGER indicates an injury immediately accessible as you read
this marking
DANGER Le de
marque: DANGER indique le risque immdiat de dommages (assessible
tandis que vous lisez la marque)

WARNING indicates an injury hazard not immediately accessible as

you read this marking
AVERTISSEMENT!
Le de marque: indique quun risque de dommages qui nest pas
WARNING immdiat alors vous lisent cette marque

CAUTION indicates a hazard to property, including the product

LATTENTION Le indique un risque a la proprit comprenant ce produit

de marque:
CAUTION

Stat Fax 4500 Operators Manual Doc. 4500 Rev. C 5

 These terms may appear in this manual:
Les marques dans loprateur manuel:
WARNING WARNING statements identify conditions or practices
that could result in injury or loss of life. WARNING
indicates an injury hazard not immediately accessible
as you read this marking.

Ces rapports identifient les conditions ou les pratiques

AVERTISSEMENT!
qui pourraient avoir comme consquence les
Le de marque:
dommages ou les pertes humaines.
WARNING

CAUTION CAUTION statements identify conditions or practices

that could result in damage to this product or other
property.
LATTENTION Le Ces rapports identifient les conditions ou les pratiques
de marque: qui pourraient avoir comme consquence les
CAUTION dommages a ce produit ou a toute autre proprit.

BIOHAZARD BIOHAZARDS are biological agents that can cause

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

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

Avertissement! Lors du fonctionnement, si on renverse des

matriaux, coupez immdiatement le courant. Placez le
commutateur lectrique a AU LOIN(0). Traitez le matriel
comme biohazardous, utilisant approprie nettoient et des
mthodes de disposition.

6 Stat Fax 4500 Operators Manual Doc. 4500 Rev. C

1.4 Safety Precautions
To assure operator safety and prolong the life of your instrument, carefully follow all
instructions outlined below.

Read Instructions Take time to read this manual carefully before using this
instrument. Review the following safety precautions to avoid injury
and prevent damage to this instrument or any products connected
to it. To avoid potential hazards, use this instrument only as
specified. For best results, familiarize yourself with the instrument
and its capabilities before attempting any clinical diagnostic tests.
Refer any questions to your instrument service provider.

Servicing There are no user-serviceable parts inside the instrument. Refer

servicing to qualified service personnel. Use only factory-
authorized parts. Failure to do so may void the warranty.

Wear Protective Many diagnostic assays utilize materials that are potential
Apparel biohazards. WARNING: Always wear protective apparel and eye
protection while using this instrument.

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

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

Observe All Terminal WARNING: To avoid fire or shock hazard, observe all ratings and
Ratings markings on the instrument. Consult this manual for further
ratings information before making connections to the instrument.

Install as Directed Stat Fax 4500 should be installed on a sturdy, level surface
capable of safely supporting the instruments weight 10 lbs (4.5
kg). The mounting surface should be free of vibrations.

Provide Proper Refer to the installation instructions for details on installing the
Ventilation product so it has proper ventilation. The instrument should be
surrounded by the following clearances: 10cm around perimeter of
unit and 10cm on top.

Do Not Operate WARNING: Do not operate this instrument with covers and panels
Without Protective removed.
Covers

Avoid Exposed WARNING: Do not touch exposed connections and components

Circuitry when power is present.

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

Dust

Stat Fax 4500 Operators Manual Doc. 4500 Rev. C 7

Safety Precautions (Continued)
Do Not Operate With WARNING: If you suspect there is damage to this instrument,
Suspected Failures have it inspected by a qualified service person.

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

Wet/Damp
Conditions

Do Not Operate In An WARNING: Do not operate instrument in an explosive

Explosive atmosphere.
Atmosphere

Keep Instrument CAUTION: Solvents such as acetone or thinner will damage the
Surfaces Clean and instrument.
Dry
Do not use solvents to clean the unit. Avoid abrasive
cleaners; the display overlay is liquid-resistant, but easily
scratched.

Clean the exterior of the instrument with a soft cloth using

plain water. If needed, a mild all-purpose or nonabrasive
cleaner may be used.

Use as a disinfectant a 10% solution of chlorine bleach (5.25%

Sodium Hypochlorite) or 70% isopropyl alcohol.

Take special care not to spill liquid inside the instrument

Operating Be sure to run a sufficient number of controls in each assay. If

Precautions controls are not within their acceptable limits, disregard test
results.

8 Stat Fax 4500 Operators Manual Doc. 4500 Rev. C

1.5 Installation

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

1.5.2 Installation/Preparation

Installation/Preparation:
Instrument Place the instrument on a flat working surface capable of safely
Placement supporting the weight of the instrument, approximately 4.5 kg (10 lbs). A
and Use clearance of at least 8cm (3) around the instrument is required to assure
optimal ventilation.

Assure Clean The circuit used should be substantially free of large voltage transients
Power (Kilovolt amp loads) such as large pumps, large centrifuges, refrigerators
Availability 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.

Power Switch Ensure that the power switch located on the power supply module is in the
Position OFF (0) position. Install the power cord with the unit power switch in the
OFF (0) position.

Stat Fax 4500 Operators Manual Doc. 4500 Rev. C 9

 AC Power Supply attached to the back of the instrument

Installation/Preparation: (Continued)
Power Cord With the power switch on the power supply module in the OFF [0]
Requirements position, insert the DC connector attached to the end of the power
supply module cable to the instrument. Insert the mating end of the AC
power cord to the inlet of the power supply module, and plug the other
end of the AC power cord into an AC outlet. Use only the power cord
and supply module specified for this product and certified for the
country of use.

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

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

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

10 Stat Fax 4500 Operators Manual Doc. 4500 Rev. C

Installation/Preparation: (Continued)
The printer will print several lines. Wait until it has stopped. If there is no printing, the
internal printer is disabled.

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

NOTE: The printer manufacturer strongly recommends the use of

thermal paper part number 150006. Contact your dealer for
replacement rolls.

Lift the tab handle located on the top of the paper

compartment toward you to open.

Place the paper roll such that the leading edge of the
paper feeds toward the front of the printer from the
bottom of the paper roll.

Leading edge of paper roll

Pull up at least 1 inch of paper and then press the compartment

cover down until it snaps closed.

NOTE: The paper will form feed when the FF key in upper right
hand corner of the display screen is pressed.

To tear the paper off the roll, gently pull the paper diagonally and
forward across the serrated tear bar. Pulling the paper straight
out may cause the gears to strip.

Stat Fax 4500 Operators Manual Doc. 4500 Rev. C 11

 1.5.3 Parts and Controls

A Cell Block
B Printer
C Read Well Top view of instrument
D Display/Touch Screen

E Power Supply Module

F Fan
G Power Supply Connection

Rear view of instrument

F
H I J
E G
K
H USB Port Type B (to be implemented in the
future)
I USB Port Type A for use with mouse; and may also
be used to upgrade firmware with a USB thumb drive.
J Stylus Holder
K Stylus

12 Stat Fax 4500 Operators Manual Doc. 4500 Rev. C

1.5.4 Touch Screen Description
The Stat Fax 4500 touch screen responds to touch pressure which
causes electrical contact between the conductive and resistive layers. The
Stat Fax 4500 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

Stat Fax
4500
Loading

Stat Fax 4500 Start up Screen

The status line displays the Lamp status (OFF or ON), the temperature of the read
well and the cell block temperature; indicates if the optional Flowcell is installed (FC)
or if in Tube (TU) mode; displays the time. The Form Feed (FF) key advances the
paper when pressed.

Flowcell (optional) installed indicator FC

Lamp status Tube mode (default) indicator TU
indicator Time

Lamp L=ON 37.0/37.0C FC 10:45 FF

Read well
Form feed key
temperature
advances the
paper when
Cell block
pressed.
temperature

Figure 1.5.4 Representation of the Stat Fax 4500 Touch Screen with optional
Flowcell installed

Stat Fax 4500 Operators Manual Doc. 4500 Rev. C 13

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

Checkout Procedure:
Visually confirm the following items:

Power cable is plugged into rear of unit and into an AC outlet.

Power switch is set to OFF (0).

The instrument is now ready for power-up.

Confirm that the instrument responds as described.

Set the power switch on the power supply module to the ON (1) position.

The screen will display as

shown in Figure 1.6-1 Screen
Display (Checkout).

The instrument will chirp

when powered on. The Stat Fax
screen will display the
Stat Fax 4500 logo 4500
as the program loads:

Loading

Figure 1.6-1 Screen Display

The printer will print out the

instrument model; firmware
information: language and
revision level; the laboratory
name (entered via Settings
menu Laboratory Name option;
default is no laboratory name);
and date and time.

Refer to Section 2.1.2 Setings

to change settings such as the
Laboratory Name, date and Figure 1.6-2 Power up print out
time.

14 Stat Fax 4500 Operators Manual Doc. 4500 Rev. C

Checkout Procedure (Continued):
The instrument will emit two chirps The screen will display time, cell and cell block
temperatures, program options, the Laboratory Name (if entered via Settings Laboratory
Name option; default is no laboratory name).

Lamp L=ON 37.0/37.0C FC 10:45 FF

Run Test Manage Tests

Settings Utilities

Figure 1.6-3 Menu

If the instrument produces results other than those described here, set the power
switch to OFF (O).

Refer to the Section 1.5.2 Installation/Preparation and review all steps carefully.

If the instrument still produces results other than those described here, refer to
Section 4. Troubleshooting, or contact your dealer for assistance.

Stat Fax 4500 Operators Manual Doc. 4500 Rev. C 15

2. OPERATING PROCEDURES
2.1 Main Menu Display

2.1.1 Run Test

User tests are stored in the instruments memory. The Stat Fax 4500 stores
up to 99 complete test setups in nonvolatile memory, making it easy for the user to
recall complete test configurations.

Tests programmed and saved on the instrument will be displayed in the Test Menu
and sorted by their test number (see sample).

Each of the test parameters, including the mode, wavelengths, standards, units, and
the ranges are all stored for reuse.

Blanks and standards (including entire standard curves) that have been read are also
saved.

When the test is recalled, the user has the option of using the previous
stored/accepted curve or reading a new one.

Select Test to RUN

Exit
1 - ABS
2 - FAC
3 - STD
4 - PTOP
SAMPLE ^
5 - REG v
6 - CS
7 - PA
Select
8 - D ABS
9 - R2
>>

Sample Test Menu

Feature Function
Arrows Use the ^ UP and V DOWN arrow keys to
highlight selection; use the >> side
arrows to advance to the next screen

Select The highlighted test is executed once the

Select key is pressed

Exit Returns to the main power on display

screen

16 Stat Fax 4500 Operators Manual Doc. 4500 Rev. C

2.1.2 Settings

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

Unit Settings
Flowcell Settings* ^
Printer Setup
Temperature Control v
Adjust Date and Time
Lamp Control Select
Beep Settings
Laboratory Name Done
Kinetic Graph Size
The functions of the Unit Settings features are:

Feature Function
Arrow Keys Utilize the arrow keys to scroll up
and down the options list or press
the option directly from the list; the
option will highlight

Select The highlighted setting is executed

once the Select key is pressed

Done Returns to the main power on

display screen

Flowcell Settings* *The Flowcell is an optional

accessory. Reference Section 5 for
more information.

Printer Setup Enables/disables the internal

printer
Allows the contrast to be adjusted
light to dark. NOTE: It is advisable
to print at contrast level 3. Higher
contrast levels may degrade after
several lengthy printouts.

Temperature Control Enables/disables cell heat and / or

block heat
Adjust Date and Time Provides access to the Set Time
option Hours, Minutes, Seconds as
well as Month, Day, Year

Stat Fax 4500 Operators Manual Doc. 4500 Rev. C 17

 Settings (Continued)

Feature Function
Lamp Control Provides access to lamp settings:
lamp idle timeout (1200 seconds)
and lamp warm up (45 seconds).

Beep Settings Provides access to touch screen

beep volume, and touch screen
beep ON or OFF settings

Laboratory Name Allows the user to customize the

laboratory name displayed. Select
Edit and an alpha-numeric keypad
displays on the screen; letters are
in lower case; for all capital letters,
press the CAP key. To enter a
space, press the SPC key. To back
space and clear, press the arrow
key. To clear the complete entry,
press the Clear key. To accept and
save the entry, press Enter. To exit
without saving the entry, press
Quit.

ACME LABS INC.

The Laboratory Name displays on

the screen as well as on printouts
(if defined).

18 Stat Fax 4500 Operators Manual Doc. 4500 Rev. C

 Settings (Continued)

Feature Function
Kinetic Graph Size The user may choose the Full
Screen option which utilizes the
whole screen, or Small. The
default is the Small setting. Once
saved, the setting remains in
effect until changed.

2.1.3 Manage Tests

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

Exit
Create Test

Edit Test
Clone Test
Delete Test

Print Test List

Figure 2.1.3-1 Manage Tests options

The functions of the Manage Tests options are:

Feature Function
Create Test Allows user to:
Name the test
Select the mode
(Absorbance, Factor,
Standard, Point to Point,
Regression, Cubic Spline)
% Absorbance
Kinetic [Rate]
o Set the Lag/Read
settings
Primary Filter
Differential Filter
Units
Decimals
Sample Blank

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 Manage Tests (Continued)

Feature Function
Create Test (Continued) Allows user to:
Standards
Controls management
Set Blank Minimum
Set Blank Maximum
Set Normal Range Low
Set Normal Range High
Define Valid Range Low
Define Valid Range High
Edit Test Lists available Tests to edit
Clone Test Allows user to duplicate an existing
test; assigns the next available test
slot number allowing for the test to
be stored.
Delete Test Lists available Tests to delete
Print Test List Printer will print the list of available
tests (maximum 99 tests)
Exit Returns to the main power on
display screen

20 Stat Fax 4500 Operators Manual Doc. 4500 Rev. C

2.1.4 Utilities
Utility menu options are as follows. Use the up and down arrow keys to view the
options or scroll along the edge to view the list. To selection an option from the list,
press the Select button. Press the Done button when finished.

Utility Menu Use these

buttons to
Show Version Details make a
Change Access Level
^ selection,
scroll
v between
options, or
Select press
Done to
Done exit.

The functions of the Utility options are:

Feature Function
Show Version Details The display will prompt:
Firmware version will
display; touch the screen Firmware Version:
to continue. Boot Loader Ver:
FTDI Ver
NOTE: THIS IS A Model: -- SAMPLE --
SAMPLE OF WHAT Build Date:
MAY BE DISPLAYED Current Time:
ON YOUR
INSTRUMENT - - - - Touch to Continue - - - -

Change Access Level Contact Technical Support for Access

Access code is for Code
technical support use only.

Stat Fax 4500 Operators Manual Doc. 4500 Rev. C 21

2.2 General Operation

2.2.1 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 generally increases precision, since the
element of variation caused by optical imperfections and non-uniform wall
thicknesses in disposable glass and plastic test tubes are removed from the results.

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. Choose a better quality reading vessel and wipe fingerprints from each
tube before reading. Mark each tube for uniform orientation when multiple readings
are desired. Determine the acceptability of the precision by reading the same tube
several times and observing the variation of the readings. Depending on the
precision requirements of your assay, monochromatic reading may or may not be
acceptable with certain plastic tubes.

TIPS FOR TUBE READING:

Wipe any dust, moisture, or fingerprints from the tubes before using.

Do not read tubes that contain bubbles or condensation.

Use a blank material with absorbance of less than 0.400A.

Use the same type and size of tube for the blank as you use for the
samples.

2.2.2 Blanking
The blank absorbance is relative to air. The user should evaluate the suitability of the
blank before using it.

Whenever additional blanking is desired, select the BLANK option.

Automatic blanking for each sample may be selected during entry of parameters in
the Standard, Factor, and Multipoint modes.

22 Stat Fax 4500 Operators Manual Doc. 4500 Rev. C

 2.2.3 Unit of Measurement Codes (Unit Code)
The list of Unit Codes will display on the Test Definition Final Page of the Factor,
Standard, Point to Point, Regression and Cubic Spline modes (see example below).
Thirteen units of measurement designations are stored for labeling the concentration
column plus a customizable designation. Select Manage Tests, select Create Test,
select a mode, and advance to the Test Definition Final Page.

Example - Mode Test Definition - Final page

2.3 Modes of Operation

Mode options are located under Manage Tests, select Create Test and the Test
Definition screen will display; press Mode and the options will display.

SELECT MODE

Absorbance Exit
Factor

Standard

Point to Point

Regression ^

Cubic Spline v

Select

Available Modes

Stat Fax 4500 Operators Manual Doc. 4500 Rev. C 23

 2.3.1 Kinetic [Rate]
All modes can be kinetic. To access the Kinetic [Rate] field, press Manage Tests,
press Create Test or Edit a Test, and a Test Definition window will display:

Example of a Test Definition page showing the Kinetic [Rate] field

To access Kinetic Parameters, select the Kinetic [Rate] field and the Test Definition
Kinetic Parameters window will display:

Kinetic [Rate] Parameters

NOTE: Most rate reactions are temperature dependent. Make sure that the cell
temperature control is enabled. Allow a minimum of 15 minutes for the cell
temperature to equilibrate.

If the instrument is left idle in Kinetic [Rate] mode, the lamp may be OFF. Be
sure to turn the lamp on and allow the instrument warm-up time before starting
a reaction.

Bichromatic readings should be used in any rate test. Always select a

differential filter; 630 nm is suggested for readings at 340 or 405 nm (reference
Section on Bichromatic Readings).

In Kinetic [Rate], the instrument takes periodic readings of a Sample at intervals.

24 Stat Fax 4500 Operators Manual Doc. 4500 Rev. C

Kinetic [Rate] (Continued)
The user supplies the Lag Time and the Read Time both in seconds:

Lag Time is the length of time that the instrument pauses before it takes the first reading,
and is measured from the point at which the user inserts the tube or aspirates the
Sample.

The Lag Time is 2 to 30,000 seconds. NOTE: The recommended Lag Time is 30
seconds or more.

Read Time is the total length of time over which the reaction is monitored.

The Read Time is 30 to 30,000 seconds.

The combined total of Lag Time plus Read Time cannot exceed 60,000 seconds.

Lag Time + Read Time # 60,000 seconds

Read Interval is the interval at which the intermediate readings are taken and recorded.

The Read Interval is 2 to 600 seconds per interval.

The A/min. or rate of the standard is determined by a linear regression calculation

covering the read interval. This A/min. is printed beside S1 and is used to determine the
rate factor.

Concentration of Standard = Factor

A/min
Alternatively, the instrument will determine the rate factor by reading a standard
of known concentration. In this case, the operator will enter the concentration
value assigned to the standard rather than a rate factor.

Choose from three calculation methods in Kinetics [Rate] mode:

Rate by Factor: Enter a factor that the instrument uses to calculate the
concentration of the sample at each reading.

Rate by Supply a standard material that the instrument reads and uses
Standard: to calculate a factor to obtain the concentration of each sample.

Fixed Time Enter a factor or supply a standard material as described

Kinetic: above. However, results are based on total , not A/min.

Note that although U/L is the common unit code for kinetic assays, the user may
select any of the 13 unit codes or customize a unit.

Most rate reactions are temperature dependent. Before beginning, verify that the
incubation block and tube well are both at 37C. Place the tubes containing the
reaction mixture into the incubation block for pre-warming. If the reagents are cold it
may take several additional minutes for them to reach 37C.

Stat Fax 4500 Operators Manual Doc. 4500 Rev. C 25

 Kinetic [Rate] (Continued)
In some cases, a Fixed Time Kinetic mode is needed, where a specific read time is
required, and the A alone is determined (not A/min).

For kinetically run tests, a color legend will display for the different colored dots on
the graph if the large kinetic graph has been selected (see Settings for more on
graph sizes).

2.3.2 Absorbance Mode

This mode will read and print sample absorbances at user selected wavelengths.

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

Absorbance Mode Test Definition page

To display the list of available modes, press the mode field with the stylus and the
Select Mode screen will display.

Select Mode screen

Use the arrow keys to scroll through the list to the desired mode, and then press the
Select button, or use the stylus to highlight a mode on the list and the Test Definition
page will display.

26 Stat Fax 4500 Operators Manual Doc. 4500 Rev. C

Absorbance Mode (Continued)
To display the Kinetic Parameters, press the Kinetic [Rate] field and the Kinetic
Parameters Test Definition page will display. For more detail, see the Kinetic [Rate]
section.

Kinetic Parameters

Select filter wavelengths by using the arrow key to scroll to the Primary Filter or
Differential Filter selection and press the Edit key. The Select Filters window will
open and display the available options:

Select Filters

Scroll up or down to highlight a selection and then press the Select key.

One by one, insert each sample tube and the differential absorbance results will print
and display.

Twenty minutes after reading the last sample, the Lamp Idle Timeout feature will
automatically turn off the lamp. 1200 seconds (twenty minutes) is the default setting.
To continue reading, place a tube in the well. The Minimum Lamp Warmup will occur
(45 seconds is the default setting), and then operation will resume where it left off.
See Settings section for more information on Lamp Control.

Stat Fax 4500 Operators Manual Doc. 4500 Rev. C 27

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

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

Select Mode screen

The Factor Mode Test Definition first page will display:

Factor Mode Test Definition - 1st Page

To display the Kinetic Parameters, press the Kinetic [Rate] field and the Kinetic
Parameters Test Definition page will display. For more detail, see the Kinetic [Rate]
section.

Kinetic Parameters

28 Stat Fax 4500 Operators Manual Doc. 4500 Rev. C

Factor Mode (Continued)
Select filter wavelengths by using the arrow key to scroll to the Primary Filter or
Differential Filter selection and press the Edit key. The Select Filters window will
open and display the available filter options:

Select Filters

Scroll up or down to highlight a filter selection and then press the Select key, or use
the stylus to make a selection.

Blank Options allows Blank to be enabled Yes/No, Sample Blank Yes/No, Range
Low, and Range High. Scroll up or down to highlight a selection and then press the
Select key.

Test Definition - Blank options

The 2nd page of the Test Definition window will display and allow editing of Factor
and Controls. Use the arrow keys to advance through the options and press the Edit
key to change the values of the selections on the screen.

Factor Mode Test Definition 2nd page

Stat Fax 4500 Operators Manual Doc. 4500 Rev. C 29

 Factor Mode (Continued)
The final page of the Test Definition window will display and allow editing of
Interpretation Mode, Units, and Decimal places.

Factor Mode Test Definition - Final page

Selecting the Interpretation Mode will open the Test Definition Interpretation window
for editing Normal Range Low, Normal Range High, Valid Range Low, and Valid
Range High. Use the arrow keys to scroll through the options, press the Edit key to
change the value of the selection. Press Save to save the selections. Note, it is very
important to use the same type and size tube for the blank as will be used for the
samples.

Factor Mode Test Definition - Interpretation

30 Stat Fax 4500 Operators Manual Doc. 4500 Rev. C

2.3.4 Standard Mode
This mode will read and print sample concentrations. A single standard material of
known concentration is used to calibrate the instrument so that concentrations of
unknown samples can be calculated according to Beer's Law. The bichromatic
absorbances at the selected wavelengths will be read, printed, and used in the
concentration calculations. The calibration factor (standard concentration / standard
absorbance) will be printed for future use.

To operate in 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
Standard.

Select Mode screen

The Standard Mode Test Definition first page will display:

Standard Mode Test Definition - 1st Page

Stat Fax 4500 Operators Manual Doc. 4500 Rev. C 31

 Standard Mode (Continued)
To display the Kinetic Parameters, press the Kinetic [Rate] field and the Kinetic
Parameters Test Definition page will display. For more detail, see the Kinetic [Rate]
section.

Kinetic Parameters

Select filter wavelengths by using the arrow key to scroll to the Primary Filter or
Differential Filter selection and press the Edit key. The Select Filters window will
open and display the available options:

Select Filters

Scroll up or down to highlight a selection and then press the Select key.

Blank Options allows Blank to be enabled Yes/No, Sample Blank Yes/No, Range
Low, and Range High. Scroll up or down to highlight the desired selection and then
press the Select key.

Test Definition - Blank options

32 Stat Fax 4500 Operators Manual Doc. 4500 Rev. C

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

Standard Mode Test Definition 2nd page

The final page of the Test Definition window will display and allow editing of
Interpretation Mode, Units, and Decimal places.

Standard Mode Test Definition - Final page

Selecting the Interpretation Mode will open the Test Definition Interpretation window
for editing Normal Range Low, Normal Range High, Valid Range Low, and Valid
Range High. Use the arrow keys to scroll through the options, press the Edit key to
change the value of the selection. Press Save to save the selections. Note, it is very
important to use the same type and size tube for the blank as will be used for the
samples.

Standard Mode Test Definition Interpretation

Stat Fax 4500 Operators Manual Doc. 4500 Rev. C 33

 2.3.5 Point to Point Mode
The Stat Fax 4500 Chemistry Analyzer accepts a number of calibrators and
calculates concentrations based on the point-to-point calibration curve. Calibrator
materials of known concentrations are used as calibrators so that concentrations of
unknown samples may be calculated. The resulting calibrator curve is a series of
lines connecting the calibrator points, which may be entered in ascending or
descending order of absorbance. The direction of slope between the first and second
calibrators determines the direction of the curve. If the direction of the curve changes
direction, the curve will be flagged as being invalid and no interpretations will be
printed.

Unknown samples are calculated as follows:

The unknown samples absorbance is read and compared to the absorbance of

the calibrator.

The line selected as the calibration curve for determining concentration at the
unknown is the line connecting the pair of standards whose absorbance are
closest above and below the unknown substance.

An unknown Sample, with absorbance higher than the calibrator with the highest
absorbance value, is calculated using a line that passes through the two
Calibrator points with the highest absorbance value. An unknown Sample with
absorbance lower than the lowest Calibrator absorbance is calculated from the
line that passes through the two Calibrators with the lowest absorbance values.

To operate in Point to Point 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
Point to Point.

Select Mode screen

34 Stat Fax 4500 Operators Manual Doc. 4500 Rev. C

Point to Point Mode (Continued)
The Point to Point Test Definition 1st Page will display the options such as a Test
Name field, Mode, Kinetic [Rate], Primary Filter, Differential Filter, and Blank Options.

Point to Point Test Definition - 1st Page

To display the Kinetic Parameters, press the Kinetic [Rate] field and the Kinetic
Parameters Test Definition page will display. For more detail, see the Kinetic [Rate]
section.

Kinetic Parameters

Select filter wavelengths by using the arrow key to scroll to the Primary Filter or
Differential Filter selection and press the Edit key. The Select Filters window will
open and display the available options:

Select Filters

Scroll up or down to highlight a selection and then press the Select key.

Stat Fax 4500 Operators Manual Doc. 4500 Rev. C 35

 Point to Point Mode (Continued)
Blank Options allows Blank to be enabled Yes/No, Sample Blank Yes/No, Range
Low, and Range High. Scroll up or down to highlight a selection and then press the
Select key.

Test Definition - Blank options

The second page of the Test Definition window will display and allow editing of
% Absorbance, Standards, and Controls. Use the arrow keys to advance
through the options and press the Edit key to change the values of the
selections on the screen. The maximum number of standards is eight.

Point to Point Test Definition 2nd page

NOTE: % Absorbance option is used with multipoint uptake assays. The standards
must be entered from darkest to lightest.

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

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

The % Absorbance option is available under the Point to Point Mode, the Regression
Mode, and the Cubic Spline Mode.

36 Stat Fax 4500 Operators Manual Doc. 4500 Rev. C

Point to Point Mode (Continued)
The final page of the Test Definition window will display and allow editing of
Interpretation Mode, Units and Decimal places.

Point to Point Test Definition - Final page

Selecting the Interpretation Mode will open the Test Definition Interpretation screen
for editing the Normal Range Low, Normal Range High, Valid Range Low, and Valid
Range High. 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. Note, it is very important to use the same type and size tube for the blank
as will be used for the samples.

Point to Point Test Definition - Interpretation

Stat Fax 4500 Operators Manual Doc. 4500 Rev. C 37

 2.3.6 Regression Mode
The instrument accepts a number of calibrators (from 2 to 7), subsequently
calculating concentrations based on the best fit (linear regression).

To operate in Regression 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 mode and press Select or use the stylus to highlight
Regression.

Select Mode screen

The Regression Mode Test Definition 1st Page will display:

Regression Mode Test Definition - 1st Page

To display the Kinetic Parameters, press the Kinetic [Rate] field and the Kinetic
Parameters Test Definition page will display. For more detail, see the Kinetic [Rate]
section.

Kinetic Parameters

38 Stat Fax 4500 Operators Manual Doc. 4500 Rev. C

Regression Mode (Continued)
Select filter wavelengths by using the arrow key to scroll to the Primary Filter or
Differential Filter selection and press the Edit key. The Select Filters window will
open and display the available options:

Select Filters

Scroll up or down to highlight a selection and then press the Select key.

Blank Options allows Blank to be enabled Yes/No, Sample Blank Yes/No, Range
Low, and Range High. Scroll up or down to highlight a selection and then press the
Select key.

Test Definition - Blank options

The second page of the Regression Mode Test Definition window will display and
allow editing of % Absorbance, Standards, and Controls. Use the arrow keys to
advance through the options; press the Edit key to change the values of the
selections on the screen. The maximum number of standards is eight.

Regression Mode Test Definition 2nd page

Stat Fax 4500 Operators Manual Doc. 4500 Rev. C 39

 Regression Mode (Continued)
NOTE: % Absorbance option is used with multipoint uptake assays. The standards
must be entered from darkest to lightest.

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

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

The % Absorbance option is available under the Point to Point Mode, the Regression
Mode, and the Cubic Spline Mode.

The final page of the Test Definition window will display and allow editing of
Interpretation Mode, Units and Decimal places.

Regression Mode Test Definition - Final page

Selecting the Interpretation Mode will open the Test Definition Interpretation screen
for editing the Normal Range Low, Normal Range High, Valid Range Low, and Valid
Range High. 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. Note, it is very important to use the same type and size tube for the blank
as will be used for the samples.

Regression Mode Test Definition - Interpretation

40 Stat Fax 4500 Operators Manual Doc. 4500 Rev. C

2.3.7 Cubic Spline Mode
Cubic Spline accepts a number of calibrators and calculates concentrations based on
the Cubic Spline (Constrained) calibration curve.

The resulting calibrator curve is a smooth curve connecting the calibrator points,
which may be entered in ascending or descending order of absorbance. A
constraining algorithm is applied to prevent curve overshoot. Concentrations of
samples which fall outside of the range of the standards (higher than the highest
standard or lower than the lowest standard) for Cubic Spline are calculated as a
Point to Point calculation. In other words, it will take the two points closest to the
sample and calculate the slope for them and then use that calculation to determine
the concentration in a linear fashion.

To select Cubic Spline mode, press Manage Tests; press Create Test; press Mode
for a list of available modes, and then select Cubic Spline.

Select Mode screen

The Cubic Spline Mode Test Definition 1st Page will display:

Cubic Spline Test Definition - 1st Page

Stat Fax 4500 Operators Manual Doc. 4500 Rev. C 41

 Cubic Spline Mode (Continued)
To display the Kinetic Parameters, press the Kinetic [Rate] field and the Kinetic
Parameters Test Definition page will display. For more detail, see the Kinetic [Rate]
section.

Kinetic Parameters

Select filter wavelengths by using the arrow key to scroll to the Primary Filter or
Differential Filter selection and press the Edit key. The Select Filters window will
open and display the available options:

Select Filters

Scroll up or down to highlight a selection and then press the Select key.

Blank Options allows Blank to be enabled Yes/No, Sample Blank Yes/No, Range
Low, and Range High. Scroll up or down to highlight a selection and then press the
Select key.

Test Definition - Blank options

42 Stat Fax 4500 Operators Manual Doc. 4500 Rev. C

Cubic Spline Mode (Continued)
The second page of the Cubic Spline Test Definition window will display and allow
editing of % Absorbance, Standards, and Controls. Use the arrow keys to advance
through the options; press the Edit key to change the values of the selections on the
screen. The maximum number of standards is eight.

Cubic Spline Mode Test Definition 2nd page

NOTE: % Absorbance option is used with multipoint uptake assays. The standards
must be entered from darkest to lightest.

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

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

The % Absorbance option is available under Point to Point Mode, Regression Mode,
and Cubic Spline Mode.

The final page of the Cubic Spline Mode Test Definition window will display and allow
editing of Interpretation Mode, Units, and Decimal places.

Cubic Spline Mode Test Definition - Final page

Stat Fax 4500 Operators Manual Doc. 4500 Rev. C 43

 Cubic Spline Mode (Continued)
Selecting the Interpretation Mode will open the Test Definition Interpretation screen
for editing Normal Range Low, Normal Range High, Valid Range Low, and Valid
Range High. 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. Note, it is very important to use the same type and size tube for the blank
as will be used for the samples.

Cubic Spline Mode Test Definition - Interpretation

44 Stat Fax 4500 Operators Manual Doc. 4500 Rev. C

3. CLEANING AND MAINTENANCE
3.1 Cleaning

3.1.1 Exterior

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

Use only water and recommended cleaners! Avoid abrasive cleaners. The
display area is liquid-resistant, but is easily scratched.

The exterior of the instrument may be cleaned with a soft cloth using plain water. If
needed, a mild all-purpose (nonabrasive) cleaner may be used. A 1.5% solution of
chlorine bleach or 70% isopropyl alcohol may be used as a disinfectant. Take special
care not to spill any liquid into the read well.

3.1.2 Flowcell (Optional)

The Flowcell should be cleaned when the instrument will not be used for an extended
period, e.g. overnight, end of shift, and when storing the Flowcell. Proper cleaning
will help to prevent clogging of the Flowcell tubing and valve tubing. Cleaning is
extremely important to obtaining accurate, repeatable results. If reagent, serum, or
other proteinaceous fluid is allowed to dry in the Flowcell, it is difficult to remove and
its presence can affect test results.

To clean the Flowcell:

1) Enable the Flowcell (use Flowcell Settings under the Utility Menu),
and place the Flowcell in the cell opening.

2) Purge with air for at least five seconds.

3) Locate the bottle of Flowcell cleaning solution. Open the bottle and
position the sample tube immersing it in the solution.

4) Aspirate a small amount of Flowcell cleaning solution into the

Flowcell by pressing the sample bar. Allow the solution to remain in
the Flowcell for three minutes.

5) Remove the bottle of Flowcell cleaning solution and replace the

cap.

6) Position a container of distilled water so that the sample tube

remains immersed.

7) Press the sample bar to aspirate distilled water into the Flowcell.
Allow the water to remain in the Flowcell for three minutes.

Stat Fax 4500 Operators Manual Doc. 4500 Rev. C 45

 To clean the Flowcell: (Continued)

OPTIONAL Aspirate 0.1N hydrochloric acid (HCI). Allow the solution to remain
in the Flowcell for three minutes.
STEP:
Purge with at least 15 mL of deionized water.

8) Press and hold the sample bar to purge until no more liquid can be
seen flowing into the Waste bottle.

9) Leave the Flowcell filled with water.

NOTE: If preparing the Flowcell for storage, follow the same instructions as
above but purge completely after cleaning.

3.1.3 Waste Bottle (Optional)

The waste bottle may be cleaned with a commercially available all-purpose cleaner
or disinfectant. A 1.5% chlorine bleach solution or 70% isopropyl alcohol may also be
used. Always turn instrument OFF before disconnecting the waste bottle.

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.

Calibration may be confirmed using Awareness Technologys Redi-Check; a

commercially available calibration check set which can be obtained from your
distributor. A periodic verification of instrument linearity is advised.

Since most lab test results are based upon standards rather than upon absolute
absorbance, the linearity of the instrument is the more critical indicator of instrument
performance. A reduction in linearity with age may be indicative of optical filter
deterioration. In this event, filter replacement is required for continued reliable
operation.

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.

46 Stat Fax 4500 Operators Manual Doc. 4500 Rev. C

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

Temperature: 10 to 50C

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

Store the instrument using original packaging if possible.

Perform the following steps before storing:

9 Set the power switch to OFF (O) and remove the power cord.

9 Place the instrument in the original packaging material.

9 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.

9 NOTE: If preparing the Flowcell for storage, follow the same instructions found in
Cleaning and Maintenance but purge completely after cleaning.

Stat Fax 4500 Operators Manual Doc. 4500 Rev. C 47

4. TROUBLESHOOTING
4.1 Error Messages
Error Messages are displayed when the instrument fails to operate correctly or
when an invalid range is entered. They are intended to help the user locate 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.

Type/Mode Error Message Solution

Calibration Error Calibration status is unknown Contact your dealer for

technical support
Example: immediately.

EEPROM Errors Test data corrupted! Checksum for Assay Data

pop-up message (including calibration data)
does not match what was
stored for that Assay

Test Definition Corrupted! Checksum for Test

Definition does not match
what was stored for that
Assay

Error Saving Assay Data! Unable to store Assay

information into EEPROM

48 Stat Fax 4500 Operators Manual Doc. 4500 Rev. C

 Error Messages (Continued)

Below is a sample of a printout which provides a representation of the location of the

Units column, the Interpretation Column, and the Results window that are mentioned
in the Error Messages that follow.

SAMPLE

In this example the

Units column is
labeled Conc.
Next is the
Interpretation column
labeled Intrp.

Results window

Type/Mode Error Message Solution

General Errors <Abs_Min Prints in ABS column if a read

displayed on screen absorbance is less than the minimum
readable absorbance for the device.

Cannot match test When running a test, if the device

wavelength with filters cannot find filters for the wavelengths
currently installed on set in the test definition.
device!

Check Linearity In Kinetic [Rate] mode, if the

absorbance per minute for any of the
intervals is more than 20% from the
mean absorbance per minute, the
printer shows Check Linearity, and
the screen will display this message.
Press the DATA button to examine the
data. See section Kinetics [Rate].

Stat Fax 4500 Operators Manual Doc. 4500 Rev. C 49

Error Messages (Continued)

Type/Mode Error Message Solution

General Errors Curve Invalid!! Standards are not steadily increasing

(Continued) - or decreasing.
displayed on screen
Printed in multi-point modes only:
Multi-point, Regression and Cubic
Spline.

Check to make sure the standards are

in decreasing order of absorbance in
the Multi-Point % Abs.

If standards are not in increasing or

decreasing order, the points will not be
connected on the graph and INVALID
CURVE! Will be displayed on the
screen as well as output to the printer.

User then has option to edit the curve if

there are enough points (minimum 3
for Point-to-Point and Regression;
minimum 4 for Cubic Spline).

Do not select the same Appears on Page 1 of Test Definition

filter for primary and when the same wavelengths are
differential entered for the Primary and the
Differential filters.

Must be between XX and Number pad range error. This occurs

XX when the user enters something
outside of the set range for that value.

Percent Absorbance This message will display if the user is

Mode should not be used in Percent Absorbance Mode and a
with negative standard is read which has a negative
absorbances! absorbance.

Wait for Lamp Warmup This message appears when the lamp
on the Photometer is not ready. It will
count down the time and the message
box will close when the lamp is ready.

Wrong date format This message refers to control (lot

(mm.yyyy)! expiration date) information on Page 2
of Test Definition, the date is not
entered in the correct format.

50 Stat Fax 4500 Operators Manual Doc. 4500 Rev. C

Error Messages (Continued)

Type/Mode Error Message Solution

Error messages >100 Appears during Percent Absorbance

that appear in the Mode when the calculated percentage
Interpretation is greater than 100 percent. In other
Column words, when the absorbance is greater
than the first standard.

DEL Standard was deleted. The

Stat Fax 4500 allows
only one standard to be
deleted.

LOW Refers to Page 3 of Test Definition.

Sample is outside Low/High range
values. OR refers to Page 2 of Test
Definition. Control is outside the
Low/High range values.

OUT Refers to Page 1 of Test Definition,

Blank is outside the Min/Max range OR
refers to Page 3 of Test Definition,
Sample is outside Low/High valid
range values.

Miscellaneous >ABS_MAX and CONC-> This message will occur if a read

****** absorbance is above the maximum
readable absorbance for the device
(Abs_Max) and the test is NOT
Absorbance Mode.

Miscellaneous >10**7 or <-10**6 Appears in Concentration Column

(Continued) when Concentration is greater than
10**7 or less than -10**6 (column only
holds seven characters maximum)

Messages that may Check Waste Bottle Will flash at the top of the screen (main
appear if the (FULL) screen or results screen in Flowcell
Flowcell (optional) Mode) if the waste bottle full sensor is
is installed triggered.

Vacuum Error Will flash at the top of the screen if the

vacuum has been running continuously
for 20 seconds. It will flash for another
40 seconds and then the machine will
be placed in Standby Mode with a
message box displaying.

Stat Fax 4500 Operators Manual Doc. 4500 Rev. C 51

5. OPTIONAL ACCESSORIES
5.1 Flowcell (Optional)
The Flowcell assembly is an optional accessory for the Stat Fax 4500 chemistry
analyzer.

Install the Flowcell assembly into the instrument:

Hold the Flowcell handle (reference Figure 5.1-1) and align the orientation pin (E),
the Flowcell (D) and the exit luer (F) into the slots provided on the instrument. Press
the button on the Flowcell handle (B) to secure the seal between the luer fittings
located on the instrument and on the bottom of the Flowcell handle (F).

To remove the Flowcell it is necessary to release the seal of the luer fittings. This is
accomplished by grasping the Flowcell handle and pulling up with a firm motion.
NOTE: Do NOT press the button as you lift the Flowcell. Pressing the button ensures
a secure seal of the luer fittings it does NOT release the seal.

A) Flowcell
handle B
B) Button
C) Sample
tube A
D) Flowcell
E) Orientation
pin D E F
F) Exit luer

Figure 5.1-1 Flowcell Assembly

When the Flowcell is installed, the user may access the Flowcell Settings under the
Utility Menu to enable and disable the Flowcell, and adjust the Sample Volume. The
Default Sample Volume is 500 l. Press the Save button to store selections.

Enable the
Status is shown
Flowcell mode
here as OFF.
by pressing ON
or OFF.

Press Save to
store settings.

52 Stat Fax 4500 Operators Manual Doc. 4500 Rev. C

 When the Flowcell is enabled, FC displays on the Main display window.

Lamp L=ON 37.0/37.0C FC 10:45 FF

Run Test Manage Tests

Settings Utilities

To initially set the value of the Blank, the Flowcell should be active but NOT inserted into
the read well. Set the reference for Blank from the Utility menu with the Flowcell
removed. Select Flowcell Adjustment, press Air Read.

Insert the Flowcell as described above making sure that the button on the Flowcell
handle as been pressed to ensure a seal of the luer fittings. Hold the container with the
fluid to be sampled so that the sample tube is below the fluid surface. Do not allow the
sample tube to lie against the bottom of the container. Press the Purge button for
aspiration to take place. The instrument will emit a beep, a click sound, followed by a
second click sound. At the second click, the container of sample fluid may be removed
from the sample tube. The instrument will perform a test reading. Press the Save button
to save the Blank reading. When prompted if loaded with water, respond Yes; when
prompted, respond Yes to store blank.

When the sample is complete, press the Purge button and the fluid will be drawn into the
Waste bottle at the rear of the instrument.

Reference Cleaning and Maintenance Section for information on cleaning the Flowcell
and Waste Bottle.

5.2 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.
Contact your dealer for replacement rolls.

5.3 REDI-CHECK Photometer QA Kit

REDI-CHECK is a photometer check set used to verify the absorbance calibration, linearity,
and precision of filter photometers on a routine basis. The kit contains four different
chromophore solutions to cover a wide range of wavelengths between 340nm and 630nm.
Instructions are included for preparing dilutions of the chromophore to check linearity.

Acceptance ranges are provided for both bichromatic and monochromatic readings, with
technical information traceable to NIST. The kit, which is designed for monthly use, also
includes a record keeping system which visually indicates instrument performance and
performance trends. For more information on REDI-CHECK, contact your dealer.

Stat Fax 4500 Operators Manual Doc. 4500 Rev. C 53

6. CONTACT INFORMATION
In the unlikely event that a problem occurs with the instrument, please consult your
dealer first.

Dealer:

If the dealer is unable to resolve the problem, support staff at Awareness Technology,
Inc. are happy to assist, and can be reached in the United States by:

Telephone: USA 772-283-6540

Fax: USA 772-283-8020

E-mail: support@awaretech.com

Mailing Address:

Awareness Technology, Inc.

P.O. Box 1679
Palm City FL 34991 USA

Important: When contacting us, please have the Model and Serial Number of the
instrument in question. Have a description of the problem with as much detail as
possible. Save any relevant printouts and send or e-mail us the information.

54 Stat Fax 4500 Operators Manual Doc. 4500 Rev. C