Awarenes Statfax-4500 Userman

Stat Fax ® 4500 CHEMISTRY CHEMISTRY ANALYZER ANA LYZER

OPER A TOR’ S M M A NU A L

©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........................................ Use....................................................... ............................. ............................ ............................ ........................... ............................ .................... ..... 1 1.1.2 Summary of the Instrument ............................ .......................................... ............................ ............................ ............................ ........................... ....................... .......... 1 1.1.3 Principles of Operation......................... Operation...................................... ........................... ........................... ........................... ........................... ........................... ...................... ........ 2

1.2 Specifications........................................................................................................................ 3

d’avertissement ............................................................... 5 1.3 Warning Markings Inscriptions d’avertissement 1.3.1 Safety Symbols Le Symboles de Sûreté ............................ .......................................... ............................ ............................ ........................... ................... ...... 5 1.3.2 Safety Terms Terminologie de Sûreté ........................... ......................................... ............................ ............................ ............................ ...................... ........ 5

1.4 Safety Precautions................................................................................................................ 7 1.5 Installation............................................................................................................................ 9 1.5.1 General ............................ .......................................... ............................ ............................ ............................. ............................. ............................ ........................... ......................... ............ 9 1.5.2 Installation/Preparation................. Installation/Preparation............................... ........................... ........................... ........................... ........................... ............................ ............................ ................ 9 1.5.3 Parts and Controls....................... Controls..................................... ............................ ........................... ........................... ............................ ............................. ............................ ............. 12 1.5.4 Touch Screen Description................... Description................................ ........................... ........................... ........................... ........................... ........................... ...................... ........ 13

1.6 Checkout Procedure ................................... ................. .................. .................. .................. .................. ................. 14

2. Operating Procedures .................................................... .................................................................................................. .............................................. 16 2.1 Main Menu Display ........................................................................................................... 16 2.1.1 Run Test...................... Test.................................... ............................ ............................ ........................... ........................... ............................ ............................. ............................. ................ 16 2.1.2 Settings ........................... ......................................... ............................ ............................ ........................... ........................... ............................ ........................... .......................... ............. 17 2.1.3 Manage Tests.................................... Tests................................................. ........................... ............................ ............................ ........................... ............................ ....................... ........ 19 2.1.4 Utilities ............................ .......................................... ............................ ............................ ............................ ............................ ............................ ........................... ........................ ........... 21

2.2 General Operation ................................... ................. .................. ................................... ................. .................. .................. .................... . 22 2.2.1 Bichromatic Differential 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................................... Mode................................................. ............................ ............................ ............................ ............................ ............................ ................ 26 2.3.3 Factor Mode.......................... Mode........................................ ............................ ............................ ............................ ............................ ............................ ........................... ................... ...... 28 2.3.4 Standard Mode............................. Mode........................................... ............................ ............................ ............................. ............................. .......................... ......................... ............. 31 2.3.5 Point to Point Mode..................................... 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........................ Exterior...................................... ............................ ........................... ........................... ............................ ............................ ............................ ............................ ................ 45 3.1.2 Flowcell (Optional)..................... (Optional)................................... ........................... ........................... ............................ ............................ ........................... ........................... ................ 45 3.1.3 Waste Bottle (Optional)................................. (Optional).............................................. ........................... ........................... ........................... ............................ ........................ .......... 46

3.2 Maintenance ................................... ................. .................. ................................... ................. .................. ................................... ................. .................. .............. 46 3.2.1 Calibration and Linearity................................. Linearity.............................................. ........................... ........................... ........................... ............................ ...................... ........ 46 3.2.2 Storage................................. 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 1.1 Applic ations 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 37°C 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 use d 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 curvefitting software, and a built-in printer to meet the requirements of modern laboratories. ®

The Stat Fax 4500 Chemistry A nalyzer nalyzer is 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 commonly applied data reduction formulae are preprogrammed 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 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 also contains a 37°C 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 37°C this is often essential to the precision of rate determinations.

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Stat Fax 4500 Operator’s

Manual Doc. 4500 Rev. C

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The Stat Fax 4500 offers quick, accurate, reproducible results; maintenancefree, 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:

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Ab so rb anc e Mod e Reads monochromatic or bichromatic differential absorbances at userselected wavelengths.

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

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

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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.

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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.

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

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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.

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1.2 Specification s 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, Pointto-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)

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Environmental Conditi ons fo r Safe Operation Indoor use Altitude up to 2000m Temperature 5°C to 40°C (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 31°C, decreasing linearity to 50% humidity at 40°C Mains supply voltage fluctuations not to exceed + 10% of nominal voltage Recommended Environmental Conditions Recommended Operating Temperature ....18-35°C Recommended Operating Humidity:..........less than 80% Design and inst rument specific ations are subject to change without noti ce.

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1.3 Warning Markings Inscriptions d’avertissement 1.3.1 Safety Sym bol s Le Symboles de Sûreté Safety symbols w hich may appear on the product : Les symbol es de sûreté peuvent apparaitre sur le prod uit:

WARNING AVERTISSEMENT

Protecti ve Groun d La Ter re El ectri qu e

CAUTION L’ ATTENTION

BIOHAZARD BIOHAZARD

Risk of Shock Risque de Choc

(Earth) Terminal Prise de Terre

Refer to Manual Se Rapport ent a Manuel

Risk of Infection Risque d’in fection

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 spécifique et des estimations courantes. Démontez l’équipement de l’alimentation d’énergie avant de remplacer le fusible.

1.3.2 Safety Terms Termin ologi e de Sûreté These terms may appear on the produ ct : Les marques sur le produi t: DANGER DANGER Le “ de marque: DANGER” WARNING AVERTISSEMENT! Le “ de marque: WARNING”

indicates an injury immediately accessible as you read this marking indique le r isque imm édiat de dommages (assessible tandis que vo us l isez la marque) indicates an injury hazard not immediately accessible as you read this marking indique qu’un r isque de dommages qui n’est pas immédiat alors vous lis ent cette marque

CAUTION

indicates a hazard to property, including the product

L’ATTENTION “ Le de marque: CAUTION”

indique un risque a la propriété comprenant c e produit

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These terms may appear in this manual: Les marques dans l’o pérateur m anuel: WARNING

WARNING statements identify conditi ons o r practices that could r esult in injur y or los s of life. WARNING indicates an injury hazard not immediately accessible as you read this marking.

AVERTISSEMENT! Le “ de marque: WARNING”

Ces rapports i dentifient les conditions ou les pratiques qui po urraient avoir c omme conséquence les dommages ou l es pertes humaines.

CAUTION

CAUTION statements identify conditio ns or practices that could result in d amage to this produc t or other property.

L’ATTENTION “ Le de marque: CAUTION”

Ces rapports i dentifient les conditions ou les pratiques qui po urraient avoir c omme conséquence les dommages a ce produit ou a toute autre propriété.

BIOHAZARD

BIOHAZARDS are biol ogic al agents that can cause disease in hum ans. Lab work ers handling potentially infectious m aterials must use universal precautions to reduce the risk of exposure to these agents.

Warning! Avertissement! WARNING: If any materials are overturned du ring 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. Av ert is sem ent ! L or s d u f on ct io nn emen t, si o n r env ers e des matériaux, coupez imm édiatement le courant. Placez le commutateur électrique a AU LOIN(0). Traitez le matériel comme biohazardous, utilisant appropr ie nettoient et des méthodes de disposition.

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1.4 Safety Precauti ons To assure operator safety and prol ong the life of your in strument, carefully foll ow all instructions outlined below. Read Instruction s

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 factoryauthorized parts. Failure to do so may void the warranty.

Wear Protective Ap par el

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

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Stat Fax 4500 should

be installed on a sturdy, level surface capable of safely supporting the instrument’s weight 10 lbs (4.5 kg). 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 and 8cm (3”) on top.

Do Not Operate Without Protective Covers

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

Avoi d Ex po sed Circuitry

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

Avoi d Exces si ve Dust

Do not operate in an area with excessive dust.

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Safety Precautions (Contin ued) 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 Atmo sp her e Keep Instru ment Surfaces Clean and Dry

Operating Precautions

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WARNING: Do not operate instrument in an explosive atmosphere. CAUTION: Solvents such as acetone or thinner will damage the instrument.

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Do not use solvents to clean the unit. Avoid abrasive cleaners; the display overlay is liquid-resistant, but easily scratched.

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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.

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Use as a disinfectant a 10% solution of chlorine bleach (5.25% Sodium Hypochlorite) or 70% isopropyl alcohol.

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Take special care not to spill liquid inside the instrument

Be sure to run a sufficient number of controls in each assay. If controls are not within their acceptable limits, disregard test results.

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

1.5.2 Installation/Preparation Installation/Preparation: Instrument Placement and Use

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

As su re Cl ean Power Av ail abi li ty

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

Power Switch Position

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

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AC Pow er Su pp ly att ached to th e bac k of th e in st ru men t

Installation/Preparation: (Contin ued) Power Cord Requirements

With the power switch on the power supply module in the OFF [0] 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.

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Installation/Preparation: (Contin ued) 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.

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1.5.3 Parts and Cont rol s A B C D

Cell Block Printer Read Well Display/Touch Screen

Top view of instrument

B A

D

C

E Power Supply Module F Fan G Power Supply Connection Rear view of instrument

F H E

J

I 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

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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:

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High touch resolution

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Pressure sensitive, works with any stylus

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Not affected by dirt, dust, water or light

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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 Tube mode (default) indicator TU

Lamp status indicator Lamp

L=ON

37.0/37.0C

FC 10:45

Read well temperature

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Figure 1.5.4 Representation of the Stat Fax Flowcell installed

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FF

Form feed key advances the paper when pressed.

Cell block temperature


Time

4500 Touch

Screen with optional


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

Checkout Procedure: Visually confirm the following i tems:

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

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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 Figur e 1.6-1 Screen Display (Checkout).

The instrument will ‘chirp’ when powered on. The screen will display the ® Stat Fax 4500 logo as the program loads:

Stat Fax 4500 Loading …

Figur e 1.6-1 Screen Dis play 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 time.

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Figure 1.6-2 Power up print out


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

Run Test

FC 10:45

FF

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. Troubl eshootin g, or contact your dealer for assistance.

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2. OPERATING PROCEDURES

2.1 Main Menu Disp lay 2.1.1 Run Test ®

User tests are stored in the instrument’s memory. The Stat Fax 4500 stores up to 99 complete test setups i n 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 1 - ABS 2 - FAC 3 - STD 4 - PTOP 5 - REG 6 - CS 7 - PA 8 - D ABS 9 - R2

Exit

SAMPLE

^ v Select >>

Sample Test Menu

Feature

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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

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2.1.2 Setting s 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 Adjust Date and Time Lamp Control Beep Settings Laboratory Name Kinetic Graph Size

^ v Select Done

The functions of the Unit Settings features are:

Feature Arrow Keys

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

Adjust Date and Time

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Settin gs (Contin ued) Feature Lamp Control

Function 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).

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Settin gs (Continued) Feature Kinetic Graph Size

Function 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 Figu re 2.1.3-1 Manage Tests op tio ns The functions of the Manage Tests options are: Feature Create Test

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



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Manage Tests (Continu ed) Feature Create Test (Continued)

Edit Test Clone Test

Delete Test Print Test List Exit

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Function 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 Lists available Tests to edit Allows user to duplicate an existing test; assigns the next available test slot number allowing for the test to be stored. Lists available Tests to delete Printer will print the list of available tests (maximum 99 tests) Returns to the main power on display screen



2.1.4 Utili ties 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 Show Version Details Change Access Level

Use these buttons to make a selection, scroll between options, or press Done to exit.

^ v Select Done

The functions of the Utility options are: Feature Show Version Details Firmware version will display; touch the screen to continue. NOTE: THIS IS A SAMPLE OF WHAT MAY BE DISPLAYED ON YOUR INSTRUMENT

Change Access Level Access code is for technical support use only.

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Function The display will prompt: Firmware Version: Boot Loader Ver: FTDI Ver -- SAMPLE Model: Build Date: Current Time:

--

- - - - Touch to Continue - - - -

Contact Technical Support for Access Code



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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 i ncreases 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 i s 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 Blankin g 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.

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2.2.3 Unit of Measur ement 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 Defini tion - 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

Avai lab le Modes

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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 p age showing t he 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.

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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 thr ee calculation methods in Kinetics [Rate] mo de: Rate by Factor:

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

Rate by Standard:

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

Fixed Time Kinetic:

Enter a factor or supply a standard material as described 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 37°C. 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 37°C.

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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 Absor bance 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:

Ab so rb anc e Mod e Test Def in it io n p age

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.

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Absorb ance Mode (Cont in ued) 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.

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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:

st

Factor Mode Test Defini tion - 1 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

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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 opti ons nd

The 2 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.

nd

Factor Mode Test Definition 2 page

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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 Defini tion - 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

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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 hi ghlight Standard.

Select Mode screen

The Standard Mode Test Definition first page will display:

st

Standard Mode Test Defini tion - 1 Page

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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 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 opti ons

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Standard Mode (Continued) nd

The 2 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.

nd

Standard Mode Test Definitio n 2 page

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

Standard Mode Test Defini tion - 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 Definitio n – Interpretatio n

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2.3.5 Poin t to Point Mode ®

The Stat Fax 4500 Chemistry An alyzer accepts a number of calibrators and calculates concentrations based on the point-to-point calibration curve. Calibr ator 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 sample’s 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 hi ghlight Point to Point.

Select Mode screen

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Point to Point Mode (Contin ued) st

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

st

Point to Point Test Definition - 1 Page


Kinetic Parameters


Select Filters

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

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Point to Point Mode (Contin ued) 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.


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.

nd

Point to Point Test Definition 2 page

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

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Point to Point Mode (Contin ued) 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

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2.3.6 Regressi on 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 st

The Regression Mode Test Definition 1 Page will display:

st

Regression Mode Test Definition - 1 Page


Kinetic Parameters 38

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Regression Mode (Contin ued) 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.


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.

nd

Regression Mode Test Definition 2 page

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

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2.3.7 Cubi c 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 st

The Cubic Spline Mode Test Definition 1 Page will display:

st

Cubic Spline Test Definition - 1 Page

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Cubic Splin e Mode (Contin ued) 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 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.


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Cubic Splin e Mode (Contin ued) 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 i s eight.

nd

Cubic Spline Mode Test Definition 2 page

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

Cubic Spline Mode Test Definition - Final page

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Cubic Splin e Mode (Contin ued) 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

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3. CLEANING AND MAINTENANCE

3.1 Cleaning 3.1.1 Exterio r CAUTION: Solvents suc h as acetone or thinn er will d amage the instru ment! Use only water and recommended cl eaners! Avo id abrasive cleaners. The displ ay area is liquid -resistant, but is easily sc ratched. The exterior of the instrument may be cleaned with a soft cloth using plain water. If needed, a mild all-purpose (nonabrasive) cleaner may be used. A 10% solution of chlorine bleach 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 (Opti onal) 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.

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To clean the Flowcell: (Contin ued) 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 B ott le (Option al) The waste bottle may be cleaned with a commercially available all-purpose cleaner or disinfectant. A 10% solution of chlorine bleach (5.25% Sodium Hypochlorite) 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 Technology’s 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.

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

•

Temperature: 10 to 50°C

•

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

Store the instrument using original packaging if possible. Perform the following steps before storing: 

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



Place the instrument in the original packaging material.



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



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

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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

Calibratio n Error

Calibr ation status is unknow n Example:

EEPROM Errors – pop-up message

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Test data corrup ted!

Solut ion Contact your dealer for technical support immediately.

Checksum for Assay Data (including calibration data) does not match what was stored for that Assay

Test Definitio n Corrupted!

Checksum for Test Definition does not match what was stored for that Assay

Error Saving A ssay Data!

Unable to store Assay information into EEPROM

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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

General Error s – displayed on screen

Solution

“
Prints in ABS column if a read absorbance is less than the minimum readable absorbance for the device.

Cannot m atch test wavelength with filters currently installed on device!

When running a test, if the device cannot find filters for the wavelengths set in the test definition.

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]”.

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Error Messages (Continued) Type/Mode

Error Message

General Error s (Continued) displayed on screen

Solution

Curve Invalid!!

Standards are not steadily increasing or decreasing. 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 s elect the same filter for primary and differential

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

Must b e between XX and XX

Number pad range error. This occurs when the user enters something outside of the set range for that value.

Percent Abs orbance Mode should not be used with negative absorbances!

This message will display if the user is in Percent Absorbance Mode and a standard is read which has a negative 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 (mm.yyyy)!

This message refers to control (lot expiration date) information on Page 2 of Test Definition, the date is not entered in the correct format.

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Error Messages (Continued) Type/Mode

Error Message

Error messages that appear in the Interpretation Column

Solution

>100

Appears during Percent Absorbance Mode when the calculated percentage is greater than 100 percent. In other 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.

Miscell aneous

“ >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 (Continued)

“ >10**7” or “ <-10**6”

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

Messages that may appear if the Flowcell (optional) is installed

Check Waste Bottle (FULL)

Will flash at the top of the screen (main screen or results screen in Flowcell Mode) if the waste bottle full sensor is 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.

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5. OPTIONAL ACCESSORIES

5.1 Flow cell (Optio nal) 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) Button C) Sample tube D) Flowcell E) Orientation pin F) Exit luer

B A

D

E

F

C

Figure 5.1-1 Flowcell Assemb ly

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 µl. Press the Save button to store selections.

Enable the Flowcell mode by pressing ON or OFF.

Status is shown here as OFF.

Press Save to store settings.

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

Lamp

L=ON

37.0/37.0C

Run Test

Settings

FC 10:45

FF

Manage Tests

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 Pri nter 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.

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