Awareness Technology Stat Fax 4700 User manual

© Awareness Technology Inc. 2010 Doc. 4700 Revised 2018 Rev. G
Stat Fax 4700
MICROSTRIP READER
O
OP PE ER RA AT TO OR R’
’S
S M MA AN NU UA AL L
®

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

Stat Fax®4700 Operator’s Manual Doc. 4700 Rev. G 1
1. Introduction
1.1 Applications
1.1.1 Intended Use
The Stat Fax®4700 is a compact, microprocessor-controlled, multi-purpose photometer
system designed to read and calculate the results of assays, which are read in microtiter
strips or break apart wells.
The Stat Fax®4700 may be used for in-vitro diagnostic testing. It is a user-programmable
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.
FOR IN-VITRO DIAGNOSTIC USE
POUR L'USAGE DIAGNOSTIQUE IN VITRO
1.1.2 Summary of the Instrument
The Stat Fax®4700 is specifically designed for bichromatic absorbance reading, however it
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.
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-to-
point 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, user-
programmable 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.

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

Stat Fax®4700 Operator’s Manual Doc. 4700 Rev. G 3
1.2 Warning Markings Inscriptions d’avertissement
1.2.1 Safety Symbols Le Symboles de Sûreté
Symbols that may appear on the product:
Les symboles de sûreté peuvent apparaitre sur le produit:
WARNING
AVERTISSEMENT
Protective Ground
La Terre Electrique
CAUTION
L’ATTENTION
BIOHAZARD
BIOHAZARD
Risk of Shock
Risque de Choc
(Earth) Terminal
Prise de Terre
Refer to Manual
Se Rapportent a Manuel
Risk of Infection
Risque d’infection
1.2.2 Safety Terms Terminologie de Sûreté
These terms may appear on the product: Les marques sur le produit:
These terms may appear in this manual: Les marques dans l’opérateur manuel:
DANGER
DANGER Le “de marque:
DANGER”
Indicates an injury immediately accessible as you read this marking
Indique le risque immédiat de dommages (assessible tandis que vous
lisez la marque)
WARNING
AVERTISSEMENT! Le “de
marque: WARNING”
WARNING statements identify conditions or practices that could
result in injury or loss of life. WARNING indicates an injury hazard not
immediately accessible as you read this marking.
Ces rapports identifient les conditions ou les pratiques qui pourraient
avoir comme conséquence les dommages ou les pertes humaines.
CAUTION
L’ATTENTION “Le de marque:
CAUTION”
CAUTION statements identify conditions or practices that could result
in damage to this product or other property.
Ces rapports identifient les conditions ou les pratiques qui pourraient
avoir comme conséquence les dommages a ce produit ou a toute
autre propriété.
BIOHAZARD
BIOHAZARDS are biological agents that can cause disease in
humans. Lab workers handling potentially infectious materials must
use universal precautions to reduce the risk of exposure to these
agents.

4 Stat Fax®4700 Operator’s Manual Doc. 4700 Rev. G
1.3 Safety Precautions
To assure operator safety and prolong the life of your instrument, carefully follow all instructions outlined
below.
Read Instructions Take time to read this manual carefully before using this instrument. Review
the following safety precautions to avoid injury and prevent damage to this
instrument or any products connected to it. To avoid potential hazards, use
this instrument only as specified. For best results, familiarize yourself with the
instrument and its capabilities before attempting any clinical diagnostic tests.
Refer any questions to your instrument service provider.
Servicing There are no user-serviceable parts inside the instrument. Refer servicing to
qualified service personnel. Use only factory-authorized parts. Failure to do
so may void the warranty.
Wear Protective Apparel Many diagnostic assays utilize materials that are potential biohazards.
WARNING: Always wear protective apparel and eye protection while using
this instrument.
Follow Operating
Instructions
WARNING: Do not use this instrument in a manner not specified by the
manual, or the protection provided by the instrument may be impaired.
Use Proper Power Cord WARNING: Use only the power cord specified for this product and certified for
the country of use.
Observe All Terminal
Ratings
WARNING: To avoid fire or shock hazard, observe all ratings and markings on
the instrument. Consult this manual for further ratings information before
making connections to the instrument.
Install as Directed The instrument should be installed on a sturdy, level surface capable of safely
supporting the instrument’s weight 5 lbs (2.3kg). The mounting surface should
be free of vibrations.
Provide Proper
Ventilation
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
(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.

Stat Fax®4700 Operator’s Manual Doc. 4700 Rev. G 5
Safety Precautions (Continued)
Do Not Operate With
Suspected Failures
WARNING: If you suspect there is damage to this instrument, have it
inspected by a qualified service person.
Do Not Operate in
Wet/Damp Conditions
WARNING: Do not operate instrument in wet/damp conditions.
Do Not Operate In An
Explosive Atmosphere
WARNING: Do not operate instrument in an explosive atmosphere.
Operating Precautions Be sure to run a sufficient number of controls in each assay. If controls are not
within their acceptable limits, disregard test results.
Keep Instrument
Surfaces Clean and Dry
CAUTION: Solvents such as acetone or paint thinner will damage the
instrument.
•Do not use solvents to clean the unit. Avoid abrasive cleaners; the display
overlay is liquid-resistant, but easily scratched.
•Clean the exterior of the instrument with a soft cloth using plain water. If
needed, a mild all-purpose or nonabrasive cleaner may be used.
•Use as a disinfectant a 10% solution of chlorine bleach (5.25% Sodium
Hypochlorite) or 70% isopropyl alcohol
•Take special care not to spill liquid inside the instrument
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.

6 Stat Fax®4700 Operator’s Manual Doc. 4700 Rev. G
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 non-break apart strips.
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.
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; thumb drive 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