HumaLyzer 2000 User PDF [PDF]

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HumaLyzer 2000 | User Manual

| Cat.No. 18391

Revision List of the Manual No. 1 2 3 4

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Rev. / Date 03/2004-04 04/2008-09 05/2008-11 02/2009-20

REVISION DESCRIPTION First edition Reformat Correction of small typing errors Adaption of maintenance chapter

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1 INTRODUCTION This manual is considered as a part of the instrument; it has to be at the operator’s hand as well as at the maintenance operator’s availability. For accurate installation, use and maintenance, please read the following instructions carefully. In order to avoid instrument or personal damages, carefully read the ”GENERAL SAFETY WARNINGS”, describing the suitable operating procedures. In case of breakdowns or any troubles with the instrument, apply to the local Technical Service. 2 USER WARRANTY HUMAN warrants that instruments sold by one of its authorised representatives shall be free of any defect in material or workmanship, provided that this warranty shall apply only to defects which become apparent within one year from the date of delivery of the new instrument to the purchaser. The HUMAN representative shall replace or repair any defective item at no charge, except for transportation expenses to the point of repair. This warranty excludes the HUMAN representative from liability to replace any item considered as expendable in the course of normal usage, e.g.: lamps, valves, syringes, glassware, fuses, diskettes, tubing etc. The HUMAN representative shall be relieved of any liability under this warranty if the product is not used in accordance with the manufacturer's instructions, altered in any way not specified by HUMAN, not regularly maintained, used with equipment not approved by HUMAN or used for purposes for which it was not designed. HUMAN shall be relieved of any obligation under this warranty, unless a completed installation / warranty registration form is received by HUMAN within 15 days of installation of this product. This warranty does not apply to damages incurred in shipment of goods. Any damage so incurred shall be re-ported to the freight carrier for settlement or claim. 3 INTENDED USE OF THE INSTRUMENT [IVD] The instrument has to be used for the expected purposes and in perfect technical conditions, by qualified personnel, in working conditions and maintenance operations as described in this manual, according to the GENERAL SAFETY WARNINGS. This manual contains instructions for professional qualified operators. 4

GENERAL SAFETY WARNINGS

Use only chemical reagents and accessories specified and supplied by HUMAN and/or mentioned in this manual. Place the product so that it has proper ventilation. The instrument should be installed on a stationary flat working surface, free from vibrations. Do not operate in area with excessive dust. Work at room temperature and humidity, according to the specifications listed in this manual. Do not operate this instrument with covers and panels removed. Only use the power cord specified for this product, with the grounding conductor of the power cord connected to earth ground. Use only the fuse type and rating specified by the manufacturer for this instrument, use of fuses with improper ratings may pose electrical and fire hazards. To avoid fire or shock hazard, observe all ratings and markings on the instrument. Do not power the instrument in potentially explosive environment or at risk of fire. Prior to cleaning and/or maintaining the instrument, switch off the instrument and remove the power cord. For cleaning use only materials specified in this manual, otherwise parts may become damaged. It is recommended always to wear protective apparel and eye protection while using this instrument. Respective warning symbols, if appearing in this manual, should be carefully considered.

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5 DISPOSAL MANAGEMENT CONCEPT The currently valid local regulations governing disposal must be observed. It is in the responsibility of the user to arrange proper disposal of the individual components. All parts which may comprise potentially infectious materials have to be disinfected by suitable validated procedures (autoclaving, chemical treatment) prior to disposal. Applicable local regulations for disposal have to be carefully observed. The Instruments and electronic accessories (without batteries, power packs etc.) must be disposed of according to the regulations for the disposal of electronic components. Batteries, power packs and similar power source have to be dismounted from electric/electronic parts and disposed off in accordance with applicable local regulations. 6 INSTRUMENT DISINFECTION Analytical instruments for in vitro diagnostic involve the handling of human samples and controls which should be considered at least potentially infectious. Therefore every part and accessory of the respective instrument which may have come into contact with such samples must equally be considered as potentially infectious. Before doing any servicing on the instrument it is very important to thoroughly disinfect all possibly contaminated parts. Before the instrument is removed from the laboratory for disposal or servicing, it must be decontaminated/disinfected. Decontamination/disinfection should be performed by a authorised well-trained personnel, observing all necessary safety precautions. Instruments to be returned have to be accompanied by a disinfection certificate completed by the responsible laboratory manager. If a disinfection certificate is not supplied, the returning laboratory will be responsible for charges resulting from non-acceptance of the instrument by the servicing centre, or from authority’s interventions. 7 NOTICE Every effort has been made to avoid errors in text and diagrams, however, HUMAN GmbH assumes no responsibility for any errors which may appear in this publication. It is the policy of HUMAN GmbH to improve products as new techniques and components become available. HUMAN GmbH therefore has to reserve the right to change specifications if necessary in the course of such improvements.

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NOTICE Analytical instruments for in vitro diagnostic application involve the handling of human samples and controls which should be considered at least potentially infectious. Therefore every part and accessory of the respective instrument which may have come into contact with such samples must equally be considered as potentially infectious.

BIOHAZARD The „BIOHAZARD“ warning label must be affixed to instrument prior to first use with biological material !

Servicing Note:

Before doing any servicing on the instrument it is very important to thoroughly disinfect all possibly contaminated parts. Before the instrument is removed from the laboratory for disposal or servicing, it must be decontaminated. Decontamination should be performed by authorised well-trained personnel only, observing all necessary safety precautions. Instruments to be returned have to be accompanied by a decontamination certificate completed by the responsible laboratory manager. If a decontamination certificate is not supplied, the returning laboratory will be responsible for charges resulting from non-acceptance of the instrument by the servicing centre, or from authority’s interventions.

HUMAN Gesellschaft für Biochemica und Diagnostica mbH | Max-Planck-Ring 21 · 65205 Wiesbaden · Germany | Tel.: +49 61 22/99 88-0 · Fax: +49 61 22/99 88-100 | e-Mail: [email protected] · www.human.de

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TABLE OF CONTENTS 1. Introduction....................................................................................................................................................................................................................... 1 1.1 Application .............................................................................................................................................................................................................................. 1 1.1.1 Intended Use ................................................................................................................................................................................................................ 1 1.2 Specifications .......................................................................................................................................................................................................................... 1 1.3 Warnings and Precautions................................................................................................................................................................................................. 3 1.3.1 Environmental Conditions ...................................................................................................................................................................................... 4 1.3.2 Description.................................................................................................................................................................................................................... 4 1.4 Setup.......................................................................................................................................................................................................................................... 5 1.4.1 Unpacking ..................................................................................................................................................................................................................... 5 1.4.2 Parts and Controls...................................................................................................................................................................................................... 6 1.4.3 Preparation ................................................................................................................................................................................................................... 9 1.4.4 Checkout ......................................................................................................................................................................................................................11 1.4.5 Self-Check....................................................................................................................................................................................................................12 1.4.6 Getting Started..........................................................................................................................................................................................................12 2. Operating Instructions .................................................................................................................................................................................................15 2.1 General Selections...............................................................................................................................................................................................................15 2.1.1 Keypad Description..................................................................................................................................................................................................15 2.1.2 Flow Cell Configuration..........................................................................................................................................................................................17 2.1.3 Temperature Control ..............................................................................................................................................................................................17 2.1.4 Lamp Warmup and Lamp Saver..........................................................................................................................................................................18 2.1.5 Printers .........................................................................................................................................................................................................................18 2.1.6 Serial Port ....................................................................................................................................................................................................................19 2.1.7 Date Format................................................................................................................................................................................................................19 2.1.7.1 Set Date and Time ................................................................................................................................................................................................19 2.1.8 Units of Measurement ...........................................................................................................................................................................................20 2.1.9 Ranges...........................................................................................................................................................................................................................20 2.1.10 Entering Names......................................................................................................................................................................................................21 2.1.11 Controls .....................................................................................................................................................................................................................21 2.1.12 Reports .......................................................................................................................................................................................................................22 2.1.13 Blanking.....................................................................................................................................................................................................................22 2.1.14 Reading Samples....................................................................................................................................................................................................22 2.1.15 Bichromatic Operation (Differential Filter)..................................................................................................................................................23 2.2 Calculation Programs ........................................................................................................................................................................................................24 2.2.1 Absorbance Mode.....................................................................................................................................................................................................24 2.2.2 Factor Mode................................................................................................................................................................................................................25 2.2.3 Standard Mode..........................................................................................................................................................................................................27 2.2.4 Multi-point Mode.....................................................................................................................................................................................................29 2.2.5 Rate Mode ...................................................................................................................................................................................................................32 2.2.6 Rate by Factor.............................................................................................................................................................................................................34 2.2.7 Rate by Standard.......................................................................................................................................................................................................37 2.2.8 Fixed Time Kinetics ..................................................................................................................................................................................................37 2.2.9 Batch Rate Mode.......................................................................................................................................................................................................38

2.3 Stored Tests ...........................................................................................................................................................................................................................39 2.3.1 Storing a Test .............................................................................................................................................................................................................39 2.3.2 Recalling a Stored Test............................................................................................................................................................................................39 2.3.3 Listing Stored Tests..................................................................................................................................................................................................40 2.3.4 Deleting a Test...........................................................................................................................................................................................................40 2.3.5 Editing a test ..............................................................................................................................................................................................................40 2.3.6 Pre-Programmed Tests...........................................................................................................................................................................................42 2.3.7 Restoring a Test.........................................................................................................................................................................................................43 2.4 Auxiliary Menu.....................................................................................................................................................................................................................44 3.0 Cleaning and Maintenance.......................................................................................................................................................................................45 3.1 Cleaning .................................................................................................................................................................................................................................45 3.1.1 Exterior .........................................................................................................................................................................................................................45 3.1.2 Flow Cell.......................................................................................................................................................................................................................45 3.1.3 Waste bottle...............................................................................................................................................................................................................45 3.2 Maintenance...................................................................................................................................................................................................................... 466 3.2.1 Calibration and Linearity .................................................................................................................................................................................... 466 3.2.2 Opening the Instrument........................................................................................................................................................................................47 3.2.3 Lamp replacement ...................................................................................................................................................................................................49 3.2.4 Flow Cell Tubing Replacement ............................................................................................................................................................................51 3.2.5 Flow Cell Adjustment..............................................................................................................................................................................................51 3.2.6 Valve tubing replacement.....................................................................................................................................................................................53 3.2.7 Waste Bottle Maintenance...................................................................................................................................................................................54 3.2.8 Storage .........................................................................................................................................................................................................................55 4. Troubleshooting .............................................................................................................................................................................................................56 4.1 Flags and Error Messages .................................................................................................................................................................................................56 4.1.1 Flags...............................................................................................................................................................................................................................56 4.1.2 Error Messages ..........................................................................................................................................................................................................56 4.1.3 Incorrect control readings .....................................................................................................................................................................................57 4.1.4 Poor linearity ..............................................................................................................................................................................................................58 4.1.5 Erratic readings .........................................................................................................................................................................................................58 4.1.6 Lamp failure................................................................................................................................................................................................................58 4.1.7 Pump runs continuously........................................................................................................................................................................................58 4.1.8 No sampling ...............................................................................................................................................................................................................58 4.2 Restore Calibration Data ..................................................................................................................................................................................................59 4.2.1 Restore Electronic Calibration .............................................................................................................................................................................59 4.2.2 Restore Filter Labels.................................................................................................................................................................................................60

1. INTRODUCTION 1.1 Application 1.1.1 Intended Use This instrument is intended to be used to read and calculate the results of in vitro clinical diagnostic assays, as well as any other application requiring absorbance or concentration readings at or near the available wavelengths. This general purpose instrument is intended to be used by laboratory professionals capable of selecting the appropriate features and options for each specific clinical application. 1.2 Specifications Specification Date .............................................. 24 January, 1997 Model Name ......................................................... Humalyzer 2000, Cat. No. 18-300 Spectrophotometer Type................................. Filter photometer Optical Configuration ....................................... Single beam with continuously rotating filter wheel Monochromatic or bichromatic reading 8 filter positions Usable Spectral Range ...................................... 330 to 700 nm System Procedures............................................. Open and by stored menu Calculating Modes.............................................. Absorbance ................................................................................... Single Standard ................................................................................... Differential samples ................................................................................... Factor Mode ................................................................................... Differential samples ................................................................................... Multi Standard Mode (up to 7 standards) ................................................................................... Multi Standard % Abs (up to 7 standards) ................................................................................... Kinetic Mode (consecutively, or simultaneously (Batch)) ................................................................................... By Factor or by Standard ................................................................................... Fixed Time Kinetic ................................................................................... By Factor or by Standard Channels ................................................................ 44 fixed, 15 open Source of Radiation............................................ Tungsten Halogen, 10 Watt, with automatic lamp saver Selection of Wavelength.................................. By filter Filter Type ................................................................ 4-cavity interference, long-life ion beam-assisted deposition Wavelength Accuracy .............................. +/- 3 nm Filter Location ............................................. After sample (heat filter before sample) Filter Selection............................................ Automatic by software or via keyboard Wavelengths ............................................... 340, 405, 505, 545, 580, 630 nm supplied standard ................................................................................... other/additional filters optional Half Bandwidth.......................................... < 10 nm 1/100 Bandwidth ...................................... 14 nm at 340 nm False Radiant Energy Ratio..................... < 0.001 at 340 and 405 nm

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Specifications (Continued) Cuvette ................................................................... Type ................................................................ Flow-through Material......................................................... 316 stainless, borosilicate windows Geometry...................................................... Cylindrical, 2.3 mm dia x 5 mm +/- 0.05 mm Illuminated Volume.................................. 21 µl Minimum Read Volume.......................... 250 µl Aspiration/Purge ....................................... Vacuum pump at 18 cm of Hg Valve............................................................... Silicone pinch type Other Vessels .............................................. 12 mm test tubes ................................................................................... 1 cm square cuvettes Cuvette Holder..................................................... Thermostatically controlled compartment at 37° C Detector.................................................................. Gallium-Arsenide-Phosphide photodiode Signal Processing and Display Display Type ................................................ 2 line x 24 character super twist LCD Scale of Display Absorbance.................................................. -0.5 to 3.5 (flow-through mode) ................................................................................... -0.5 to 2.5 (tube or 1 cm cuvette) Concentration............................................. Maximum 999,999 Kinetic Results ............................................ Abs/min with resolution of 0.0002 A/min Zero Compensation ........................................... Automatic Range ............................................................. -0.5 to 2.0 absorbance Signal Outputs Parallel .......................................................... Centronics/IBM-PC compatible Serial............................................................... RS-232 at 2400 baud, 8 data, 1 stop, no parity Spectrophotometric Inaccuracy Flow-through .............................................. < 0.5 % at 1 absorbance, 340/630 nm NADH solution ................................................................................... < 1% at 2 absorbance, 340/630 nm NADH solution ................................................................................... < 3 % at 3 absorbance, 340/630 nm NADH solution ................................................................................... < 0.5 % at 1 absorbance, 405/630 nm PNP solution ................................................................................... < 1 % at 2 absorbance, 405/630 nm PNP solution ................................................................................... < 3 % at 3 absorbance, 405/630 nm PNP solution Stability................................................................... Better than 0.003 A/hr monochromatic after warmup ................................................................................... Better than 0.001 A/hr bichromatic after warmup Warmup Time...................................................... 90 seconds photometric ................................................................................... 15 minutes for temperature compartment Electronics ............................................................. Z80 microprocessor ................................................................................... 8 K bytes Static RAM (SRAM) ................................................................................... 8 K bytes Non-volatile RAM (NVRAM) Power Supply........................................................ 115/230 VAC, 50/60 Hz, +/- 10%, 60 VA Dimensions and Weight ................................. 35 x 40 x 15 cm, 10 kg Space Requirements.......................................... 10 cm clearance on all sides

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1.3 Warnings and Precautions WARNING Some diagnostic assays utilize material which is potentially biohazardous. Always wear protective apparel and eye protection while using this instrument. Always operate the instrument with safety equipment and fixtures in place. If the waste bottle is overturned during operation, immediately set the power switch to OFF (O). If this occurs, the instrument may discharge a small amount of waste material from the waste bottle via a fitting on the bottom of the unit. This material should be treated as potentially biohazardous. CAUTION The voltage select switch setting must match the local AC line voltage or permanent damage to the instrument may occur. The instrument must be operated will all covers and dress panels in place. Do not block the fan outlet at the rear of the instrument or block the air inlets on the underside of the chassis. Observe clearances around the instrument. Solvents such as acetone or thinner will damage the instrument. Do not use solvents to clean the unit. Avoid abrasive cleaners. The cover, keypad and display are liquid-resistant, but are easily scratched. Please take time to read this manual carefully before using the instrument. For best results, familiarize yourself with the instrument and its capabilities before attempting any clinical diagnostic tests. Refer any questions to your instrument dealer. Retain the original packing material for future use in the event that the instrument is placed in storage, shipped to another location, or returned for service.

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1.3.1 Environmental Conditions This instrument is intended for indoor use at temperatures between 15°C and 35°C and at between 10% and 85% relative humidity, non-condensing. The instrument must be placed on a stationary flat working surface at least 61 cm deep. The instrument must have at least 10 cm clearance at the sides and rear. 1.3.2 Description The instrument is a general-purpose, bichromatic photometer system with six available wavelengths and 37°C incubation. Two additional wavelengths are optional. A removable Flow Cell installs in the read well to provide extremely rapid fluid sampling with low carryover. A built-in vacuum pump and an external autoclavable waste bottle with level sensing are supplied standard. When the Flow Cell is removed, the instrument accepts standard 12 mm round tubes as well as 1 cm square cuvettes. The instrument also contains an incubation block with 12 round tube stations. Both the incubation block and the read well are temperature controlled to 37°C. The 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, flags and error messages, and minimal maintenance requirements. The operating modes are: 

Standard Mode reports concentrations based on a single standard concentration.



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 change in absorbance over a specified interval. The Rate Mode includes a “Batch” option that permits kinetic assays to be run simultaneously.



Factor Mode reports concentrations by multiplying absorbances by a specified factor.



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



Multi-point Mode reports concentrations or percent absorbances based on the point-to-point connection of up to seven user-supplied standards.

In the Factor and Standard modes, differential samples (against sample blanks) are supported. Tests, parameters, and standard curves are stored in memory for later recall. The first 44 tests are pre-programmed for use with assays available from Human GmbH. You can customize the parameters and standards of these tests as needed to meet your assays’ specific requirements. In addition to the pre-programmed tests, you can program an additional 15 user tests for later recall.

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1.4 Setup 1.4.1 Unpacking Carefully unpack the instrument. Report any visible damage to your freight carrier at once. NOTE: Retain the original packing material for future use in the event that the instrument is placed in storage, shipped to another location or returned for service. You should find the following items packed with the instrument. Please locate each item now before you continue. Remove all packing material and retain. Included items

Description

Waste bottle

Glass bottle ,vinyl-clad

Cleaning solution

Plastic bottle containing Flow Cell cleaning solution

Bottle cap assembly

Bottle caps, tubes, sensor wires

Paper rolls

(2) Thermal printer paper

Paper roll cover

Smoked plastic

Power cable

Heavy cord

Flow Cell

Rectangular object with square extension, in plastic box

Spare tubing and tool kit

Description

Valve tubing

Silicone tube

Sample tube, long

Teflon tube, swaged end, for sample vol. >350µl

Sample tube, short

Teflon tube, swaged end, for sample vol. - 350µl

Exit tube

Teflon tube w/ male Luer attached

Tube gasket

Foam rectangle with round hole

Tubing gripper

Rectangle of emery paper

Hex wrench

1.6 mm

Owner’s Manual

This document

Contact your distributor if anything is missing.

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1.4.2 Parts and Controls

C

B E

A

D

K F

J I H G

Parts and Controls (Front of instrument) A

Rear dress panel

B

Printer

C

Printer paper roll

D

Display

E

Keypad

F

Incubation block

G

Sample tube

H

Sample bar

I

READY indicator

J

Flow Cell

K

Flow Cell exit tube

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Parts and Controls (Continued)

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Parts and Controls (Continued)

A

G I B J

C D E

F

H

Parts and Controls (Rear of Instrument) A

Parallel port

B

Sensor jack

C

Vacuum fitting blue

D

Waste fitting (white)

E

Bottle strap

F

Fan outlet

G

Serial port

H

Power inlet

I

Power switch

J

Voltage select switch

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1.4.3 Preparation 1.

Complete this procedure to prepare the instrument for operation.

2.

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

3.

If there is a label indicating that the valve tubing must be placed into the valve prior to operation, open the cover of the instrument (see the section “Opening the Instrument” under “Cleaning and Maintenance: Maintenance”). Install the loose valve tubing into the valve. Figure 6 (located immediately before the section “Valve tubing replacement” shows a diagram of the valve tubing location. Replace the cover and continue.

4.

Refer to Figure 1 for the remainder of this procedure. Place the waste bottle on the work surface behind the instrument. Position the waste bottle so that the tubing and sensor lead are not kinked, twisted, or strained. Do not place undue stress on the tubing connections or sensor lead connector. Tighten the bottle cap firmly.

5.

Connect the waste bottle tubes to the rear panel fittings. The tubing connections are color-coded; match the male Luer cap to the color coding ring on the rear panel. The vacuum line fittings are blue and the waste line fittings are white. Turn the fittings clockwise only until finger-tight. Do not over tighten.

6.

Plug the sensor lead into the sensor jack on the rear panel.

7.

Place the bottle into the harness provided for it on the rear of the unit. Pull the strap so that the bottle is held tightly then press it together so that the Velcro seals.

8.

Locate the power switch on the rear panel. Check that the power switch is in the OFF (O) position.

9.

Locate the voltage select switch on the rear panel. This switch configures the instrument to accept either 230 V or 115 V input. Do not connect the instrument to the AC supply before checking the voltage select switch. Ensure that the voltage select switch is set to the correct voltage. To change the voltage select switch, insert a straight screwdriver blade into the slot on the switch, and slide it firmly into the other position.

WARNING: The voltage select switch setting must match the local AC line voltage or permanent damage to the instrument may occur. 10. Connect the supplied power cable to the rear of the instrument as shown. Plug the other end of the power cable into an AC outlet. For use at 110-120 V in the United States, you must use a UL listed cord set with a minimum 18 AWG, Type SVT or SJT 3 conductor cord, maximum 15 feet (4.5 m) in length, rated 10A, 125V, with a parallel blade, grounding type attachment plug. For use at 220-240 V in the United States, use a UL listed cord as above, rated 250V, with a tandem blade, grounding type attachment plug. For use elsewhere, refer to local regulations. 11. Install the Flow Cell in the read well so that the sample tube is toward the front and the exit tube is toward the rear. Press the Flow Cell gently down into the read well. Connect the fitting on the exit tube to the fitting on the instrument. Turn the fitting clockwise only until finger-tight. Do not over tighten.

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12. Set the power switch at the left rear of the instrument to ON (1). The display shows Humalyzer 2000 G 

The printer will print several lines. Wait until it has stopped.

13. Locate the roll of printer paper. Roll out 15 cm of paper from the roll. Be sure that the leading edge of the paper is straight. Cut it straight across with scissors if needed. Feed the leading edge of the paper into the slot inside the opening in the rear dress panel. Figure 1 shows the direction of the paper feed. While feeding the paper as described, press the PAPER key repeatedly until the paper "catches" and begins to feed into the printer. When you see the printer paper exit at the top of the printer, stop pressing the PAPER key. 14. Locate the paper roll cover. Install to the opening in the rear dress panel, by pressing inward on the tabs on each side of the printer roll cover. 15. Locate the bottle of Flow Cell cleaning solution. Open the bottle and position it so that the sample tube is immersed in the solution. Press PURGE to aspirate cleaning solution into the Flow Cell. Remove the bottle of cleaning solution and replace the cap. Allow the solution to remain in the Flow Cell for 3 minutes. 16. Position a container of distilled water so that the sample tube is immersed. Press PURGE to aspirate water into the flow cell. Allow the water to remain in the Flow Cell for 3 minutes. 17. Press and hold the PURGE key until no more water can be seen flowing into the waste bottle. 18. Set the power switch to OFF (O) and continue to the section “Checkout”.

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1.4.4 Checkout Follow this procedure to verify that the instrument is ready for use. In this procedure, it is assumed that the Flow Cell is being used. If you are using the instrument with tubes or square cuvettes, disregard the Flow Cell information. Visually confirm the following items: 

Waste bottle is connected to the correct fittings.



Sensor lead is plugged in.



Waste bottle is empty.



Waste bottle cap is tight.



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



Flow Cell is fully seated in read well and Luer fitting is connected. (If Flow Cell in use.)



Power switch is set to OFF (O).

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

Set the power switch at the left rear of the instrument to ON (1)

The display will show: Humalyzer 2000 G The printer will print a header containing the instrument model, software revision, laboratory name, and the date and time. Humalyzer 2000 G Lab: LABNAME 01/01/94 08:30 Flow Cell Active The letter following the colon is the software revision. If the date and time are incorrect, set the date and time as described in the section entitled “Set Date/Time”. Allow the instrument to equilibrate for at least 15 minutes. The incubation block and the read well must be at 37°C.

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When the instrument is ready for use, the display will show the main prompt: Ready: Select a Test Block: 37.0 Cell: 37.0 

Press and hold the PURGE key. The valve will open and you will hear the internal pump running to restore the vacuum. Release the PURGE key. The valve will close and the pump will continue to run for about 15 seconds, and then shut off. The pump may run intermittently as the vacuum stabilizes.

If the instrument produces results other than those described here, set the power switch to OFF (O). Go to the section entitled “Setup” and review all steps carefully. Repeat the Checkout procedure. If the instrument still produces results other than those described here, refer to the section entitled “Troubleshooting”, or contact your dealer for assistance. 1.4.5 Self-Check The instrument continuously self-checks to insure proper operation. Any error will be immediately reported. The SelfCheck feature provides additional tests. To perform the check, press the SELF CK key. The display shows messages such as this when performing the tests: System Diagnostics: SRAM OK Any test failures will be reported on the display and printer. 1.4.6 Getting Started There are 44 pre-programmed tests available for use with Human assays. All of the test parameters, including the mode, wavelengths, standards, units, and ranges are stored for reuse. Blanks and standards (including entire standard curves) that have been read are also saved. To recall a test, press MENU. The instrument prompts you to enter the number of the test you wish to run. Use the numeric keys to enter the test number and press ENTER. The test is recalled and the test parameters are printed. To print a list of all of the tests, press MENU, type in 99, and press ENTER. The listing is included at the end of this section. For a closer look at the instrument’s capabilities, refer to the other sections of the manual. This section gives you brief step-by-step instructions to use the instrument with the Human GLUCOSE liquiUV Hexokinase method test, in standard mode. Before continuing, be sure the instrument is prepared for use by completing the procedures in the sections entitled Setup and Checkout.

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You may cancel any operation at any time and revert to the main prompt by pressing CLEAR twice. 

Press MENU. Type 10 and press ENTER. The display shows: Standard Mode

The printer outputs a header showing information about the stored test: 10)Glucose HK (S) Name of test Updated: 01/01/94 Date last updated/modified 01/01/94 :G 14:55 Current date, software revision, time Standard Mode Operating mode Sample Volume=500uL Aspiration volume (indicates Flow Cell Mode) Wavelngths=340 630nm Filter wavelengths (primary/differential) Standard#1= 100.0 Standard #1 is equal to 100.0 units Norms: 75.0to 115.0 The normal range is 75 to 115 units Linear: to 700.0 The test is linear up to 700.0 units -------------------S# Abs mg/dL I Sample#, Absorbance, Units, Index -------------------

If the lamp has not completed its 90 second lamp warmup, the display shows: Standard Mode Lamp Warmup: XX Secs



The lamp warmup time shown is the number of seconds remaining until the lamp has reached operating temperature.



When the lamp warmup is complete, the display shows: 10)Glucose HK Read the blank



(S)

Position the container of blank reagent under the sample tube so that the tube is below the NOTE: The instrument automatically purges with air after making the absorbance readings. Be sure to remove the sample container after the instrument beeps.



Fluid surface. When the green READY light on the front of the instrument is on, press and release the sample bar. The instrument will beep, and then aspirate the sample. Remove the blank material from the sample tube after the sample is aspirated. The instrument purges with air automatically after the absorbance is read. The sample tube must not be immersed when this occurs.



The display shows: 10)Glucose HK (S) Sampling 10)Glucose HK (S) Reading



The printer outputs the absorbance and concentration for the blank and the display briefly shows it as well: B

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0.0



The display then shows: 10)Glucose HK (S) Read Standard



Aspirate the standard fluid as described above for the blank. Remove the container when you hear the beep. The printer outputs the absorbance, concentration, and factor for the standard: S1 1.105 Factor= 90.5



100.0

The display then shows: 10)Glucose HK (S) Read Sample



Aspirate the sample fluid as described above for the blank. Remove the container after you hear the beep and the sample is aspirated. The printer outputs the sample number, absorbance and concentration for the sample and the display shows it as well. Note that the letter to the right indicates a low value (out of normal range). 1

0.551

49.8L

You may continue to read samples, or you may cancel and return to the main prompt at any time by pressing CLEAR twice in succession. You may re-blank at any time by pressing BLANK and repeating the steps listed above for blanking. A listing of pre-programmed tests can be found under “Pre-programmed tests” in the section “Operating Instructions: Stored Tests.”

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2. OPERATING INSTRUCTIONS 2.1 General Selections 2.1.1 Keypad Description Refer to Parts and Controls and Figure 2.1.1-1, Keypad Layout. Many keys have multiple features, some of which are active only in certain modes. In general, the left-hand keypad is used for mode selection and numeric data entry, whereas the right-hand keypad is used for selecting options, programming and configuration. Below is a brief description of each key. Keys with multiple features are listed as separate keys.

Figure 2.1.1-1 Keypad Layout

Left-hand keypad 0-9

Numeric input

STND

Selects Standard Mode

RATE

Select Rate Mode

FACT

Select Factor Mode

ABS

Select Absorbance Mode

PGM

Selects Multi-point (programmable) mode & Multi-point % abs mode

%ABS

Has no function

DATA

Prints Rate-by-factor interval data

AUX

Access Auxiliary menu

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Left-hand keypad (Continued) PLOT

Plot curves or Rate reactions

BLANK

Read blank

LAMP

Turn lamp on/off

PAPER

Feed paper on internal printer

CLEAR

Clear input or revert to previous/main prompt

ENTER

Accept input

Right-hand keypad STORE

Save test

EDIT

Modify test data

DEL

Delete currently selected test

TEMP

Display current block/cell temperature

CELL

Configure Flow Cell

VOL

Set sample volume

FILT

Print menu of available wavelengths

UNITS SELF CK

Print menu of available units of measurement Perform internal self-check

TIME

Display or edit date/time

PRNT

Select printers

PURGE

Purge Flow Cell

MENU

Recall stored tests

READ

Select characters from list

16

2.1.2 Flow Cell Configuration The Flow Cell configuration allows you to select tube mode or make the Flow Cell active, change the aspirate (sample) volume, and read and store water reference values. When installing the Flow Cell to an instrument that has already reached temperature equilibration (about 15 minutes from power-on), allow at least 5 minutes for the Flow Cell to equilibrate after insertion. For optimal performance of the Flow Cell, be sure that the instrument is placed on a level surface. Press CELL to configure the Flow Cell settings. The display shows: Flow Cell Settings Flow Cell Active Y/N Press NO to use tubes or cuvettes, or press YES to use the Flow Cell. If you select NO, remove the Flow Cell before continuing. If you selected YES for Flow Cell active, install the Flow Cell before continuing. Flow Cell Settings Change Aspirate Vol Y/N Press NO to continue or press YES to change the aspirate volume. If you press YES, the display shows: Flow Cell Settings Sample Volume 750uL Y/N. Press YES again to select the volume shown or press NO to show other available volumes. The available sample volumes are 250, 300, 350, 400, 450, 500, 600, and 750 µl. Press YES to select the displayed volume. The printer outputs the volume that you select. Note that the VOL key performs this function directly. NOTE: If you select a sample volume which is 350 µl or less, you must also install the shorter sample tube (3.8 cm) provided in the tubing kit. Refer to the section “Flow Cell tubing replacement”. The display then shows: Flow Cell Settings Read Water Y/N Press YES to read a new water reference, or press NO to continue. The instrument references water instead of air when reading with the Flow Cell. These reference values are stored in non-volatile memory. The instrument uses the stored values whenever the Flow Cell is active, until new values are read. 2.1.3 Temperature Control When no software mode is selected (press CLEAR twice), the temperatures of the read well and incubation block are displayed continuously. The display shows (for example): Ready. Select a Test Block: 37.0 Cell: 36.8h The temperature of the cell and block is automatically controlled to 37°C by the software. A small ‘h’ will appear after the temperature when the heating element for the particular incubator is turned on.

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The cell temperature control can be disabled for use at ambient temperature. To enable or disable cell temperature control, press TEMP. The display shows: Ready: Select a Test Cell T.Cntrl 1=ON 0=OFF Press 0 to disable cell temperature control, or 1 to enable. If cell temperature control is disabled, the message “Cell Temp Ctrl Off!” is printed. Selecting any of the Rate Modes will automatically enable cell temperature control. Note that even with temperature control disabled, the ambient temperature of the cell is somewhat higher than room temperature. Allow at least 15 minutes for the instrument to equilibrate after enabling or disabling cell temperature control. When installing a room-temperature cuvette or the Flow Cell to an instrument that has already reached temperature equilibration (about 15 minutes from power-on), allow at least 5 minutes for the cuvette or the Flow Cell to equilibrate after insertion. To view the temperature at any time, press TEMP. The prompt to turn cell temperature control on or off clears after a moment and the temperature is displayed for several seconds. 2.1.4 Lamp Warmup and Lamp Saver The lamp must warm up for 90 seconds before any readings can be taken. As soon as the lamp is turned on the warmup time begins and continues to count down. If you select a test very quickly, the instrument will pause until the warmup time has elapsed. The message Lamp Warmup:XX Secs is displayed and the time XX will count down to zero. When the warmup is complete the instrument will proceed. If the instrument has not been used in approximately 15 minutes, the lamp will automatically be turned off to extend the service life of the lamp. The display shows “Lamp Saver”. Select a test or mode, or press LAMP to turn the lamp on. 2.1.5 Printers The instrument has a built-in 20 column thermal graphics printer that is used to list information and provides a record of the samples. An external printer may be connected to the parallel or serial port on the rear of the unit. Any Epson compatible printer and standard parallel cable may be used with the parallel port. Contact your distributor for a special cable for use with a serial printer. When connecting an additional printer or an external PC, the instrument must be switched off. After terminating the connection, you may put the instrument into operation again. To advance the paper, press PAPER. The paper continues to advance as long as you hold down the key. To select printers, press PRNT. The display shows: Ready: Select a Test Internal Printer ON Y/N Press YES to enable the internal printer, or press NO to disable. The display then shows: Ready: Select a Test External Printer ON Y/N

18

Press YES to enable external printer or press NO to disable. You may select either, both, or neither of the printers. The data is output to both printers in the same format. If the external printer is enabled, and the printer is connected but is off-line, an error results when the instrument attempts to print. The instrument stops and displays PRINTER NOT READY until the problem is corrected. In the event that the external printer buffer becomes full (i.e., the instrument has sent as much data as the printer’s memory can hold), the instrument’s display will prompt you to “Retry.” You may retry to continue printing after the printer has emptied its buffer. 2.1.6 Serial Port By using a special cable, a serial printer or computer with a serial port may be connected. This is a male 9-pin DBstyle connector using RS-232 signals in a non-standard pin out. The data format is 2400 baud, 8 bits, 1 stop bit, and no parity. Contact your distributor to obtain a serial printer cable. The pin out for the serial port is: 1

GND

2

TX

3

RX/DTR

4-9

NC

2.1.7 Date Format The date can either be displayed as DD.MM.YY (day, month, year) or as MM/DD/YY (month, day, year). To change the date format, press MENU, enter 100, and press ENTER again. The display will show: Ready: Select a Test 0=MM/DD 1=DD.MM Press 0 for MM/DD/YY or press 1 for DD.MM.YY, and then press ENTER. Press TIME to check the date and time. The current date and time are displayed for approximately two seconds, and then cleared. The date and time are printed automatically when you start the instrument, and when you select a software mode. 2.1.7.1 Set Date and Time To change the time and date, press TIME, then press EDIT. After about one second, the display will show: Ready: Select a Test Enter Date as DD.MM.YY or Ready: Select a Test Enter Date as MM/DD/YY depending on the date format currently selected.

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Using the numeric key pad, type in the day, month, and year; or the month, day and year, depending on the date format. Each must be two digits. You may separate each number with either a slash or a decimal point. In the first example, to set the date to 15 May, 1997, type in 15.05.97 and press ENTER. You may leave the date unchanged by simply pressing ENTER. After you have entered the date, you are prompted to enter the time as HH.MM.SS. Enter the hours, minutes, and seconds (24 hour format) in the same way that you entered the date. 2.1.8 Units of Measurement In all modes except Absorbance Mode, you have the option of selecting units of measurement. Units are provided to label the calculated concentrations, but have no bearing on the actual calculation. The display shows: (Mode Name) Mode Enter Units Code There are fourteen unit codes. To list the codes and the units, press UNITS and the complete list will be printed: Unit Menu by Key 0 1 2 3 4 5 6

Conc g/L g/dL mg/dL μg/L μg/dL U/L

7 8 9 10 11 12 13

meg/dL mmol/L mcmo/L IU/mL μkat/L μmol/L mol/L

When prompted to select units, press the numeric key that corresponds to your choice. The units for that code are displayed. To confirm your choice press ENTER. To select a different unit, press a different numeric key. 2.1.9 Ranges In all modes except Absorbance Mode you have the option of entering ranges. The ranges are saved when a test is saved. When the display shows something similar to: Standard Mode Set Ranges Y/N press YES to set ranges. If you press NO, the instrument will continue normally. Standard Mode Enter Low Normal Enter the concentration that is the lowest value of the normal range. The instrument then prompts you to enter the high normal. Enter the highest value in the normal range. You then have the option to enter the low and high value of the linear range. Enter the values as for the normal range.

20

Any value can be skipped by simply pressing ENTER. For example, if you enter 20, 50, 10, 100 for the four values, the ranges will be printed as Norms: 20.0 to 50.0 Linear: 10.0 to 100.0 When the instrument takes a reading, a letter indicating the range (none, L, H, R) is shown to the right of the concentration on both the display and the printer. Standard Mode 3 0.785 60.5H The possible range letters are: None

The concentration fell inside both the normal and linear ranges.

L

The concentration is lower than the Low Normal, but is inside the linear range.

H

The concentration is higher than the High Normal, but is inside the linear range.

R

The concentration is outside the linear range.

2.1.10 Entering Names It is sometimes necessary to enter an alphanumeric name. For instance, you can name user tests and controls, and you can change the laboratory name shown in the header. When you are prompted for a name, the following display is shown: ABCDEFGHIJKLMNOPQRSTUVWX READ=Let ENT=Done The cursor is the small underline beneath the “A” on the top line. Press 4 to move the cursor to the left or press 6 to move the cursor to the right. When the cursor is beneath the first letter of the name you wish to enter, press READ. The bottom line clears and shows the letter that you selected. Continue using the 4 and 6 keys and READ to select each letter in the name. You can hold down 4 or 6 to move the cursor quickly. When you complete the name, press ENTER. If you wish to remove a letter from the end of the name, press CLEAR. To cancel and return to the main prompt, press CLEAR twice. 2.1.11 Controls The instrument allows you to enter and name up to 4 controls. Controls are designated samples which provide an expected result, providing a reference for comparisons. The controls can be given names up to 15-characters in length. When the display shows "Read Sample", you can designate the next sample as a control by pressing AUX. The display then shows Label as Control Y/N Press YES to view the control names. The display will show each of the control names in order. Press NO to view the different control names, or press YES to select the displayed control name and designate the next sample as a control. For information on naming the controls, see the section “Auxiliary Menu”.

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2.1.12 Reports The instrument provides full-page reports to the external printer, showing the stored patient data and interpretations along with logged information such as the test name, date and time, controls used, and includes spaces for laboratory and technician information. Patient data is stored and retrieved by test number, and there is room for a total of 255 samples. To print a report: 1.

At the end of shift or reporting period, press CLEAR twice so that the instrument is at the main prompt. Press DATA. The display shows: Printing Data Report Select a Test

2.

Type in the desired test number and press ENTER. The display shows: Setup External Printer Then Press Enter

3.

Load the external printer with paper and set it to top of form. Make sure the printer is on line, and then press ENTER to print the report. The display shows: Printing Data Report

4.

When the report is complete, the display shows: Report printed Clear Samples Y/N

5.

Press YES to clear the samples for the test you selected. None of the other samples will be affected. Press NO to return to the main prompt without clearing the samples.

You can repeat this procedure as needed for any or all tests. 2.1.13 Blanking The instrument prompts you to “Read the blank” each time a mode is selected or a test is recalled (optionally). Insert a tube containing blank material, or sample the blank material using the flow cell. (See “Reading Samples” below.) The absorbance of the blank will be printed with a ‘B’ in place of the sample number. Note that in Rate Mode the value of the blank is not printed. To re-blank the instrument without re-selecting the mode, press BLANK. The blank absorbance that is printed is relative to air when in tube mode. In Flow Cell mode, it is relative to the stored water values. In this way the user can evaluate the suitability of the blank before using it. 2.1.14 Reading Samples Using tubes or cuvettes: The instrument prompts you to “Read the blank” or “Read sample”. Insert the tube or cuvette into the read well. The instrument takes the reading, and displays and prints the result. After the result is displayed, you may remove the tube. The instrument prompts you to insert the next tube.

22

Using the Flow Cell: The READY indicator on the front of the instrument will light and the display will prompt you to “Read the blank” or “Read sample”. 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. Quickly press and release the sample bar. The instrument will automatically sample the preset amount. Remove the sample container from the sample tube after you hear the instrument beep. When the reading is complete the sample will be automatically purged from the Flow Cell and drawn into the waste bottle at the rear of the instrument. When the instrument is ready for the next sample, the READY indicator illuminates, and the instrument prompts you to read the next sample. 2.1.15 Bichromatic Operation (Differential Filter) The instrument allows you to read bichromatically with no increase in read time. Use the instrument bichromatically whenever possible, especially in Rate Mode. Typically, you would us 630 or 580 as the differential filter for 340 or 405 nm primary wavelengths. In general, select the differential filter whose color is the same as the chromophore you are reading. Wavelength

23 Human HumaLyzer 2000 User Manual

Chromophore

340

UV

405

purple

505

blue green

545

emerald green

580

yellow

630

red

2.2 Calculation Programs 2.2.1 Absorbance Mode In Absorbance Mode, the instrument reads and prints sample absorbances at selected wavelengths. The instrument prints the date and time and the mode of operation. A typical printout is shown below. 1.

Press ABS. The display shows: Select Primary Filter Key 1 = 340nm

2.

The bottom line briefly shows each of the possible wavelengths. Press the numeric key that corresponds to the desired wavelength. To confirm the choice, press ENTER. The selected wavelength is displayed and printed.

3.

The display shows: Select Differential Filt Key 1 = 340nm Select the differential wavelength in the same way you chose the primary wavelength and press ENTER. The absorbance at the differential wavelength will be subtracted from the absorbance at the primary wavelength. In this way, the repeatability of the reader is improved since any differences such as tube imperfections are referenced out. Press 0 to read monochromatically. It is recommended that you use the instrument in bichromatic mode whenever possible.

4.

If the instrument is in tube mode, it displays “Referencing Air” and makes an air reference reading. Do not attempt to insert a tube or press a key while the reader is referencing air. In Flow Cell mode, the stored water values are used as a reference.

5.

The display then shows: Absorbance Mode Read the blank Insert the blank tube or sample the blank material. See the section “Blanking” for details.

6.

The display shows: Absorbance Mode Read sample Insert the tube or sample the material. See the section “Reading samples” for details. Repeat this step as required. You may re-blank at any point by pressing BLANK. To exit Absorbance Mode and return to the main prompt, press CLEAR twice quickly. The instrument prints “Test Ended” and returns to the main prompt.

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2.2.2 Factor Mode In Factor Mode, the instrument reads absorbances at the selected wavelengths, and calculates concentrations by multiplying the absorbance by the user supplied factor. A typical printout for Factor Mode is shown below.

1.

Press FACT to select Factor Mode. The display shows: Ready: Select a Test Differential Samples Y/N

2.

Press YES to use differential samples. This works exactly as described below, except that each sample has its own blank, rather than using the same blank for all subsequent samples. The instrument automatically prompts for the blank preceding each sample. If you do not wish to use differential samples, press NO to continue.

3.

The display shows: Select Primary Filter Key 1 = 340nm The bottom line briefly shows each of the possible wavelengths. Press the numeric key that corresponds to the desired wavelength. To confirm the choice, press ENTER. The selected wavelength is displayed and printed.

4.

The display shows: Select Differential Filt Key 1 = 340nm Select the differential filter. Select the differential wavelength in the same way you chose the primary wavelength and press ENTER.

5.

The display shows: Factor Mode Enter Factor

25 Human HumaLyzer 2000 User Manual

Type in the factor using the numeric keypad and press ENTER. To clear a mistake and re-enter the factor press CLEAR once. When you press ENTER, the factor is shown on the printer. Note: The instrument will not accept a factor which is more than seven digits, and there can be only one decimal place. 6.

The display shows: Factor Mode Enter Units Code Enter the units code (0-13) and press YES. See the section “Units of Measurement” for details. Press UNITS for a printed menu of units. In the example printout shown above, “0” was selected which printed “Conc” in the heading.

7.

The display shows: Factor Mode Set Ranges

Y/N

Press YES to specify a normal and/or linear range, or press NO to continue. If you press YES, enter the values as described in the section “Ranges”. The range interpretation will be printed in the far right column. 8. If the instrument is in tube mode, it displays “Referencing Air” and makes an air reference reading. In Flow Cell mode, the stored water values are used as a reference. 9.

The display then shows: Factor Mode Read the blank Insert the blank tube or sample the blank material. See the sections “Blanking” and “Reading samples” for details.

10. The display shows: Factor Mode Read sample Insert the tube or sample the material. Repeat this step as desired. To exit the mode and return to the main prompt, press CLEAR twice quickly. The printer outputs “Test Ended”, and the instrument returns to the main prompt. You may re-blank at any point by pressing BLANK.

26

2.2.3 Standard Mode In Standard Mode, the instrument reads and prints absorbances, and calculates concentrations based on a standard material of known concentration. Results are calculated according to Beer’s Law. The calibration factor is printed for future use. A typical printout for standard mode is shown below.

1.

Press STND to select Standard Mode. The display shows: Ready: Select a Test Differential Samples Y/N Press YES to use differential samples. This works exactly as described below, except that each sample has its own blank, rather than using the same blank for all subsequent samples. The instrument automatically prompts for the blank preceding each sample. If you do not wish to use differential samples, press NO to continue.

2.

The display shows: Select Primary Filter Key 1 = 340nm The bottom line briefly shows each of the possible wavelengths. Press the numeric key that corresponds to the desired wavelength. To confirm the choice, press ENTER. The selected wavelength is displayed and printed.

3.

The display shows: Select Differential Filt Key 1 = 340nm Select the differential wavelength in the same way you chose the primary wavelength and press ENTER.

4.

The display shows: Standard Mode Enter Factor Enter the value of the standard. Type in the value using the numeric keypad on the left, and press ENTER when you are done. To clear a mistake and re-enter the factor press CLEAR. The standard concentration is then printed. Note: The instrument will not accept a factor which is more than seven digits, and there can be only one decimal place.

27 Human HumaLyzer 2000 User Manual

5.

The display shows: Standard Mode Enter Units Code Enter the units code (0-13) and press YES. See the section “Units of Measurement” for details. Press UNITS for a printed menu of units. In the example printout shown above, “8” was selected which printed “mmol/L” in the heading.

6.

The display shows: Standard Mode Set Ranges Y/N Press YES to specify a normal and/or linear range, or press NO to continue. If you press YES, enter the values as described in the section “Ranges”. The range interpretation will be printed in the far right column.

7.

If the instrument is in tube mode, it displays “Referencing Air” and makes an air reference reading. In Flow Cell mode, the stored water values are used as a reference.

8.

The display shows: Standard Mode Read the blank Insert the blank tube or sample the blank material. See the sections “Blanking” and “Reading samples” for details.

9.

The display shows: Standard Mode Read standard Insert the standard tube or sample the standard material. See the section “Reading samples” for details. The instrument will read the absorbance and determine the factor such that the concentration of the standard is the value that you specified. The calculated factor will be printed.

10.

The display shows: Standard Mode Read sample Insert the tube or sample the material. The concentration will be calculated by multiplying the absorbance by the factor calculated from the standard. Repeat this step as desired. To exit Standard Mode and return to the main prompt, press CLEAR twice quickly. The printer outputs “Test Ended”, and the instrument returns to the main prompt. You may re-blank at any point by pressing BLANK.

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2.2.4 Multi-point Mode In Multi-point mode, the instrument reads and prints absorbances, and calculates the concentration based on the concentrations of the standards. Up to seven standards can be entered. The absorbances of the standard are used to construct a point-to-point curve which passes through all of the standards and the point (0,0). Unknown samples are calculated by finding the two standard points whose absorbances are the closest above and below the unknown. The concentration for the unknown sample is then calculated using Beer’s Law. A typical printout of Multi-point mode, with an internal graph plot, is shown below:

1.

Press PGM to select Multi-point Mode. The display shows: Ready: Select a Test Multi % Abs Y/N

2.

Press NO to choose between the Multi-Point % Abs Mode and normal Multi-Point Mode. The Multi-point %Abs mode is identical in calculation to the Multi-Point mode, except that the percent absorbance is calculated and printed, and the standards must be in descending order. Also, Multi-point % Absorbance does not support graphing or test reporting. Press YES to select the displayed mode and continue.

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NOTE: In Multi-point mode, the standards should be in order from lightest to darkest. In Multi-point % Abs mode, standards must be in order from darkest to lightest. 3.

The display shows: Select Primary Filter Key 1 = 340nm The bottom line briefly shows each of the possible wavelengths. Press the numeric key that corresponds to the desired wavelength. To confirm the choice, press ENTER. The selected wavelength is displayed and printed.

4.

The display shows: Select Differential Filt Key 1 = 340nm Select the differential wavelength in the same way you chose the primary wavelength and press ENTER.

5.

The display shows: Multi-Point Mode Enter Number of Stndrds Type in the number of standards (1-7) and press ENTER.

6.

The display shows: Multi-Point Mode Enter Value Stndrd# 1 Type in the value, in units, of the standard and press ENTER. To clear a mistake and re-enter the standard press CLEAR once. When you press ENTER, the value is shown on the printer. Repeat this step for each standard.

7.

The display shows: Multi-Point Mode Enter Units Enter the units code (0-13) and press YES. See the section “Units of Measurement” for details. Press UNITS for a printed menu of units. In the example printout shown above, “2” was selected which gives “g/dL” in the heading.

8.

The display shows: Multi-Point Mode Set Ranges Y/N Press YES to specify a normal and/or linear range, or press NO to continue. If you press YES, enter the values as described in the section “Ranges”. The range interpretation will be printed in the far right column.

30

9. 10.

If the instrument is in tube mode, it displays “Referencing Air” and makes an air reference reading. In Flow Cell mode, the stored water values are used as a reference. The display shows: Multi-Point Mode Read the blank Insert the blank tube or sample the blank material. See the sections “Blanking” and “Reading samples” for details.

11.

The display shows: Multi-Point Mode Read standard# 1

12.

The instrument prompts you to read each of the standards in turn. Insert the standard tube or sample the standard material. See the section “Reading samples” for details. If any of the standards is less than the previous standard (greater than if using Multi-point % Abs Mode), it will be marked with an “X” and the instrument will print: —CURVE INVALID!Since this invalidates the results, you must repeat the procedure from the beginning.

13.

The display shows: Plot the curve Y/N Press YES to plot the standard curve. While the plot is being generated, the display shows: Plotting... The plot shows the absorbance along the vertical axis, the concentration along the horizontal axis, and the sample numbers along the plotted line.

14.

The display shows: Multi-Point Mode Read sample Insert the tube or sample the material. The concentration will be calculated as described above. Repeat this step as desired. To exit Multi-Point Mode and return to the main prompt, press CLEAR twice quickly. The printer outputs “Test Ended”, and the instrument returns to the main prompt. You may re-blank at any time by pressing BLANK.

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2.2.5 Rate Mode In Rate Mode, the instrument takes periodic readings of a sample at intervals. 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 you insert the tube or aspirate the sample. Read time is the total length of time over which the reaction is monitored. The read time must be a multiple of 30 seconds. The read interval is the interval at which the intermediate readings are taken and recorded, and is fixed at 30 seconds. You can choose from three variations of the Rate Mode. Rate by Factor

you supply a factor which the instrument uses to calculate the concentration of the sample at each reading.

Rate by Standard

you supply a standard material which the instrument reads and uses to calculate a factor to obtain the concentration of each sample.

Fixed Time Kinetics

you supply either a factor or a standard material as described above, however, readings are taken only at the beginning and the end of the Read time.

In addition, Rate by Factor and Rate by Standard tests may be performed singly (consecutively) or in batch mode (simultaneously). Most rate reactions are temperature dependent. Make sure that the cell temperature control is enabled as described in the section “Temperature Control”. You should allow a minimum of 15 minutes for the cell and block to equilibrate. You should also allow more than 90 seconds for the lamp to warm up, to make sure the photometer system is as stable as possible. When placing cold or room temperature samples into the incubation block, allow an additional 5 minutes for the samples to reach 37°C. NOTE: Bichromatic readings should be used in any Rate Mode test. Always select a differential filter. 630 nm is suggested for readings at 340 or 405 nm. See the section “Bichromatic Readings”.

NOTE: When using round test tubes in Rate Mode, you must first install the tube gasket supplied. To install the tube gasket, open the cover as described in the section “Opening the instrument”. Remove the adhesive backing on the gasket. Apply the gasket to the top side of the read well. Be sure to align the round hole in the gasket with the square opening in the read well.

32

Rate factors for determining units per liter (U/L) must be derived from the following standard formula: U/L = DA/min. x 1000 x TVmL x TF MA x SVmL x LPcm where: U/L

is units per Liter

ÐA/min is the mean change in absorbance per minute TV

is the total volume of the reaction mixture (in ml)

MA

is the molar absorptivity (the MA of NADH at 340nm, for example, is 6.22 X 10 3)

SV

is the sample volume (in ml)

LP

is the cuvette light path (in cm)

TF

is the temperature factor used to convert the assayed activity to the desired temperature.

A typical Rate Mode printout is shown below. Although the example shows Rate by Factor, the Rate by Standard and Fixed Time Kinetics are similar. Refer to the sections “Rate by Standard” and “Fixed Time Kinetics”.

33 Human HumaLyzer 2000 User Manual

2.2.6 Rate by Factor

1.

Press RATE to select Rate Mode. The display shows: Ready: Select a Test Batch Mode Y/N

2.

Press YES to select Batch Mode, NO to run assays consecutively. The display shows (if not in batch mode; see the discussion below for batch mode specifics): Ready: Select a Test Fixed Time Kinetic Y/N

3.

Press NO to continue. Press YES to run Fixed Time Kinetic. See the section below, “Fixed Time Kinetics”.

4.

The display shows: Ready: Select a Test Rate Standard or Factor Press FACT to select Rate by Factor. Press STND to select Rate by Standard. See the section below, “Rate by Standard”.

34

5.

The display shows: Select Primary Filter Key 1 = 340nm The bottom line briefly shows each of the possible wavelengths. Press the numeric key that corresponds to the desired wavelength. To confirm the choice, press ENTER. The selected wavelength is displayed and printed.

6.

The display shows: Select Differential Filt Key 1 = 340nm Select the differential wavelength in the same way you chose the primary wavelength and press ENTER.

7.

The display shows: Rate by Factor Enter Lag Time (Secs) Enter the lag time in seconds and press ENTER.

8.

The display shows: Rate by Factor Enter Read Time (Secs) Enter the read time in seconds and press ENTER. You must enter a read time which is a multiple of 30 seconds.

9.

The display shows: Rate by Factor Enter Factor Enter the factor and press ENTER. To clear a mistake and re-enter the factor press CLEAR once. When you press ENTER, the factor is shown on the printer. Note: The instrument will not accept a factor which is more than seven digits, and there can be only one decimal place.

10.

The display shows: Rate by Factor Enter Units Enter the units code (0-13) and press YES. See the section “Units of Measurement” for details. Press UNITS for a printed menu of units.

11.

The display shows: Rate by Factor Set Ranges Y/N Press NO to continue. Press YES to enter range values. Refer to the section “Ranges” for details.

35 Human HumaLyzer 2000 User Manual

12.

The display shows (if not in batch mode; see the discussion below for batch mode specifics): Rate by Factor Read the blank Read the blank. Its value is printed.

13.

The display shows: Rate by Factor Read sample Insert the tube or sample the material. Also, at any time the display shows “Read Sample” after you have read a sample, you can press the PLOT key (9) to plot the reaction curve. While the plot is being generated, the display shows: Plotting... The plot shows the absorbance along the vertical axis and the time along the horizontal axis. Note that a vertical line indicates the break between the lag phase and the read phase, and the read time label of the horizontal axis begins at 0.

14.

The display shows: Rate by Factor Lag 60 Abs 0.430 The lag time starts at the value you supplied and counts down. The absorbance is continuously displayed.

15.

When the lag time has elapsed, the display shows: Rate by Factor Read 60 Abs 0.430 The read time starts at the value you supplied and counts down. The instrument beeps as it takes each reading.

16.

The final answer is calculated by taking the mean absorbance per minute from all of the intervals. This answer is printed to the right of the sample as shown in the example printout. If you entered ranges, the range interpretation is printed to the right of the concentration. Press DATA at any time before reading the next sample if you wish to print the interval data. The absorbance at 0, 30, and 60 seconds is printed along with the mean absorbance per minute for each interval (0-30 and 30-60). Using this data, it is possible to gauge the linearity of the reaction. If any of the absorbances for the sample are greater than 2.2, a message is printed stating this. If the absorbance per minute for any of the intervals is less than 0.010, the printer outputs “Low Activity” and the display shows: Rate by Factor Print Interval Data Y/N

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Press YES to print the data. You can examine the data to determine if the sample was not active, or if the reaction started later in the read time. If the latter is the case you may need to increase the lag time. If the absorbance per minute for any of the intervals was more than 20% from the mean absorbance per minute, the display shows: Rate by Factor Check Linearity

Y/N

Press YES to print the interval data as described above and as shown in Sample #4. Otherwise, press NO. If either Low Activity or Check Linearity are flagged, you may still print the interval data by pressing the DATA (7) key. Refer to the example printout. In Sample #1 the reaction proceeded normally and the answer was printed. In Sample #2 a sample with low activity was read. In Sample #3 the reaction ran to completion and began slowing down. Check Linearity was not selected, so no interval data was printed. In Sample #4 the interval data was printed. 17.

Go to step 12 for additional samples. To exit Rate Mode and return to the main prompt, press CLEAR twice. The printer outputs “Test Ended”, and the instrument returns to the main prompt. You may re-blank at any point by pressing BLANK.

2.2.7 Rate by Standard Rate by Standard is very similar to Rate by Factor except that the factor is determined by dividing the given concentration of the standard by its absorbance. This factor is then used to determine the concentration of the unknown samples. The prompts are similar to those listed above for Rate by Factor. If the standard absorbance is greater than 2.2, the mode is canceled and the instrument returns to the main prompt. 2.2.8 Fixed Time Kinetics Fixed Time Kinetics is similar to the other Rate Mode variations. However, instead of basing the final calculation on the mean absorbance per minute of the sample, the calculation is performed with the change in absorbance over the read interval. In addition, the Low Activity and Check Linearity conditions will not be displayed, and neither Batch Rate nor interval data reporting is available.

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2.2.9 Batch Rate Mode Batch Rate Mode is used in conjunction with Rate by Standard or Rate by Factor to read tests simultaneously, rather than consecutively. Because Fixed Time cannot be performed this way, the prompt is unavailable. Also, prior to running the blank, you will be prompted to enter the number of samples. Note that if you are running Rate by Standard, you must include your standard as one of your samples. The maximum number of samples = 12. After you read the blank, the display shows: Rate by (Factor or Standard) Add Serum/ Press Enter Add the patient samples to the pre-warmed reagent tubes. Adding them in a uniformly-timed manner will ensure that your lag time is consistent across the batch. After all samples have been added, press ENTER to begin the lag time countdown. After the lag time is completed, the display will prompt you to read your tubes. Read your tubes in the same uniformly-timed manner in which the samples were added. Assign control labeling when the display is prompting you to read that sample. After all samples in the batch have had their initial reading, the display will show the remainder of the read time countdown. Note that the read time will begin when the initial reading of the first sample is taken. At the end of the read time, you will be prompted again to read your samples. Again, read your tubes in the same uniformlytimed manner in which the samples were added. After each tube is read, its results will be printed. The instrument will print the actual read time for each sample, and will compensate with a corrected Abs/min answer. Note that interval data and plotting are not available, because the sample does not remain in the cuvette well for the length of the rate reaction. After the last sample has been read, the printer will print “*** END OF BATCH***” and the Rate Mode will discontinue.

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2.3 Stored Tests The instrument has the capability to store complete test setups in non-volatile memory. This makes it easy for the user to recall complete test configurations. 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 you are given the option of reusing the old standard or reading a new one. There is room for approximately 59 tests, 44 of which have been pre-programmed with tests compatible with Human assays. 2.3.1 Storing a Test To save a new test, select a mode and answer all of the configuration questions. When the instrument is ready to make readings, press STORE. The instrument finds an available test number and saves the setup. The display shows: Standard Mode Name the Test

Y/N

If you wish to enter a name for the test, press YES. The purpose of the name is simply to help you keep track of the tests that you have stored. The name is shown on the display while you are running the test, and it is printed when you print a list of all stored tests. If you choose NO the test will simply be labeled User Test. If you save the test and then read the blank and/or standards, those values will also be saved along with the test. After the test has been saved, the instrument continues with normal operation using your selected features. 2.3.2 Recalling a Stored Test Press MENU. The instrument prompts you to enter the number of the test you wish to run. Use the numeric keys to enter the test number and press ENTER. The test is recalled and the parameters printed just as if you had selected the mode and entered all of values manually. The test name is printed along with the date of the last modification. The modification date is the date the stored blank and standard values were updated. If there are no stored blank and standards, then the date is when the test was originally stored. The blank and curve data is printed and the display shows (for example): Standard Mode Use Stored Blank Y/N Press YES to use the stored blank. The stored value will be used as if it had just been read. If you answer NO, you will be asked to read a new blank. The display then shows: Standard Mode Use last Calibrat. Y/N

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Press YES to use the stored factor or standard curve. If you press NO you will be asked to read new values. If you are recalling a Multi-point % Abs Mode and you choose to use the stored calibration you will be asked to read the first standard only. If a stored curve is not used, and there are stored samples in memory, the display shows: Sample History Will Be Cleared Continue Y/N Press NO to abort the test, or press YES to clear the stored samples and continue. If there was no stored blank or standard curve, or you have chosen not to use them, the values that you read now will be automatically saved under the recalled test. When you recall the test the next time you will be given the option to use the stored calibration as described above. 2.3.3 Listing Stored Tests To print out a list of all of the pre-programmed tests and user tests, press MENU, type in 99, and press ENTER. The numbers and names of all stored tests are printed. 2.3.4 Deleting a Test If you find that you no longer need one of the stored tests you may delete it. This makes room for another stored test. From the main prompt, press DEL. The instrument prompts you for a test number. Type in the number of the test that you wish to delete and press ENTER. Press YES to confirm the deletion of the test or NO to cancel. You may also delete any of the pre-programmed tests; however no user tests can be stored in those locations. 2.3.5 Editing a test Any of the tests can be edited, and any of the stored parameters can be changed with the exception of the mode. To edit a test, press EDIT while the instrument is at the main prompt. You will be asked to enter the number of the test that you wish to edit. Using the numeric keypad, type in the test number and press ENTER. NOTE: Editing a test will erase any stored blank or standard values for that test, as well as any stored samples. All of the test's parameters will be recalled and printed. The display shows: Standard Mode Edit Filters Y/N Press YES to change the filter wavelengths, or NO to continue. The instrument prompts you to select the primary and differential filters.

40

The instrument will ask a series of questions. If you press YES, you will be asked to enter the new value just as you were when the test was originally stored. The questions depend on the mode of the test that you are editing. For example, if you are editing a factor mode test, you will be asked if you would like to change the factor. If you are editing a rate test you will be asked if you would like the change the lag and read times. When you complete the questions, the instrument prints “Edit Complete”. NOTE: It is possible to change any of the parameters of a preprogrammed test. You may need to do this if the assay manufacturer were to change a required factor, for example. The original preprogrammed test parameters can always be restored. Refer to the section “Restoring Pre-programmed tests”.

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2.3.6 Pre-Programmed Tests There are 44 pre-programmed tests for use with Human assays. They are stored in permanent memory. These tests contain the parameters to run the named assays. Pre-programmed tests are recalled as described above. A listing of these tests is shown below. Always refer to package inserts when performing assays.

(S) = method with standard (F) = method with factor

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2.3.7 Restoring a Test Because it is possible to edit pre-programmed test parameters, the instrument also provides a means of recalling the original pre-programmed test. This is called restoring a test. Any changes that you make affect only the restored copy of the pre-programmed test. The instrument is supplied with all of the pre-programmed tests already restored. NOTE: If you restore a pre-programmed test, all blank and standard values for that test will be deleted, as well as all stored samples for that test. To restore a test, press MENU, type 101, and then press ENTER. The display shows: Ready: Select a Test Restore A Menu Test Y/N Press YES to copy just one pre-programmed test. The instrument then prompts you for the test number. Type in the number of the pre-programmed test that you wish to restore and press ENTER. You will be asked to confirm that you wish to restore this test. Press YES to restore the test, or press NO to cancel. When you recall the test the instrument will require that you read new blank and standard values. If you answer NO to the “Restore a Menu Test” prompt the display shows: Ready: Select a Test Restore Entire Menu Y/N NOTE: If you restore the entire menu of pre-programmed tests, ALL of the user tests and ALL of the stored samples will be erased! If you press YES, all of the pre-programmed tests will be copied to working memory from permanent memory. This will erase any of the changes you have made to the pre-programmed tests and will delete all of the stored blank and standard values, as well as all of the user tests and any stored samples.

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2.4 Auxiliary Menu Several features are accessed with the Auxiliary menu. The Auxiliary menu is only available when the instrument is at the main prompt. Press AUX. The display shows: Auxiliary Functions Enter Lab. Name Y/N The laboratory name is printed at startup, and on reports, to help identify the printed records. Press NO to select the next feature, or press YES to enter your laboratory name. If you press YES, enter a name as described in the section “Entering Names”. Auxiliary Functions Label Controls Used Y/N Press NO to select the next feature, or press YES to enter names for controls 1-4. If you press YES, the display shows: Enter Control 1 Y/N Press YES to enter the name for control 1, or press NO to select a different control. Control names are entered as described in the section “Entering Names”. Auxiliary Functions Print Control Names Y/N Press NO to return to the main prompt, or press YES to print the control names.

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3.0 CLEANING AND MAINTENANCE 3.1 Cleaning 3.1.1 Exterior CAUTION: Solvents such as acetone or thinner will damage the instrument! Use only water and recommended cleaners! Avoid abrasive cleaners. The keypad and display areas are liquid-resistant, but are easily scratched. The exterior of the instrument may be cleaned with a soft cloth using plain water. If needed, a mild all-purpose (nonabrasive) cleaner may be used. A 1.5% solution of chlorine bleach or 70% isopropyl alcohol may be used as a disinfectant. Take special care not to spill any liquid into the read well. 3.1.2 Flow Cell The Flow Cell should be cleaned when the instrument will not be used for an extended period, e.g. overnight, end of shift, and when storing the Flow Cell. Proper cleaning will help to prevent clogging of the Flow Cell 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 Flow Cell, it is extremely difficult to remove and its presence can affect test results. To clean the Flow Cell: 1.

Purge with air for at least 5 seconds.

2.

Aspirate a small amount of Flow Cell Cleaner ([REF] 18222). Allow the solution to remain in the Flow Cell for 3 minutes.

3.

Aspirate 15 ml of distilled water then purge with air for 5 seconds.

4.

Aspirate 0.1N hydrochloric acid (HCl). Allow the solution to remain in the Flow Cell for 3 minutes.

5.

Purge with at least 15 ml of deionized water.

6.

If the Flow Cell is to be removed for storage, purge with air until no more fluid can be seen flowing into the waste bottle. Otherwise, leave the Flow Cell filled with water.

Material required [REF]

18222

Flow Cell Cleaner Detergent NaOH Sodium azid

Chemicals HCl Disinfectant: Isopropylalcohol Sodium hypochlorite (bleach) 7.

100 ml 0.1% < 0.5% 0.1%

0.1 N

70% or 1.5%

3.1.3 Waste bottle The waste bottle may be autoclaved or it may be cleaned with a commercially available all-purpose cleaner or disinfectant. A 1.5% chlorine bleach solution or 70% isopropyl alcohol may also be used.

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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 2A. 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 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 absorbances, 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 Opening the Instrument Refer to Figure 3, Instrument Interior. The cover is hinged at the rear panel, and can be raised to allow access to the inside of the instrument. Disconnect the power cable, the tubing, and the sensor lead from the rear panel. Move the instrument forward until the front edge overhangs the work surface. Locate and remove the cover screw from the underside of the front edge. Gently lift the front of the cover upward, taking care to clear the incubation block and photometer. Prop the cover open with a suitable object. Do not force the cover backwards. Damage to the cover or fittings may result. To reinstall the cover, reverse the procedure. Carefully lower the cover until it seats on the chassis, taking care to clear the incubation block and the Flow Cell Luer fitting.

Cover (raised)

Main PCB

Transformer

Pump control PCB

Pump

Incubation block Valve Lamp

Photometer

Cover screw Figure 3 - Instrument Interior

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3.2.3 Lamp replacement The lamp should be replaced only if it fails to light, or several filter voltages are reported as low. To replace the lamp, follow the procedure below. 1.

Place the instrument in tube mode as described in “Flow Cell Configuration”.

2.

Open the instrument as described in “Opening the Instrument”. Locate the photometer and the lamp at the right side of the photometer. Refer to Figure 4-A, Lamp Removal and Replacement. The figure shows the right side view of the photometer assembly.

CAUTION Lamp is HOT. Allow the lamp to cool before handling. 3.

Loosen but do not remove the 2 center lamp connector screws. Remove the lamp by lifting upward.

4.

Use a pair of pliers or tweezers to handle the new lamp. Avoid handling with bare skin. Insert the lamp leads into the connector until they hit bottom. Refer to Figure 4-B, Lamp Alignment. The lamp filament must be centered on the lens and the lamp body must be parallel with the lens bracket. While holding the lamp in alignment, tighten the lamp connector screws.

5.

Set the power switch to ON. Observe the projection of the light from the lamp onto the cell holder (behind the lens). Refer to Figure 4-C, Spot Alignment. The spot should be small and centered on the oval hole in the cell block (behind the lens). If the spot is not centered, use the adjustment screws to position the spot. The vertical adjustment screw raises and lowers the lamp bracket. The lamp bracket is slotted at the horizontal adjustment screw, so that the lamp bracket can be moved. The horizontal adjustment screw serves to lock down the lamp bracket.

6.

Insert a borosilicate 12 mm tube filled with plain water into the read well. Do not use a soda-lime glass tube, since it does not transmit at 340nm. Press MENU. Type 186 and press ENTER. The instrument will print the detected voltage for each filter position. All voltages should be between 2.00 volts and 11.00 volts. If all the voltages report low, repeat steps 5 and 6.

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Figure 5 - Flow Cell tubing removal and replacement

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3.2.4 Flow Cell Tubing Replacement The Flow Cell utilizes 1.2 mm I.D. Teflon tubing for the sample and exit tubes. Replacement tubing is included with the tubing kit. Follow this procedure to replace the Flow Cell tubing. 1.

Remove the Flow Cell. Unscrew the Luer and lift the Flow Cell out of the read well.

2.

Remove the cover screws and lift off the upper Flow Cell cover.

3.

Refer to Figure 5. Disconnect the exit tube from the steel tube. Pull the exit tube out through the bulkhead. Remove the cell insert screws and pull the cell insert and the sample tube out. Remove the sample tube from the steel tube.

4.

Select the long or the short sample tube. The short sample tube must be used when the sample volume is set to 350 µl or less. Carefully press fit the end of the sample tube with the red dot (swaged end) to the steel tube on the cell insert, and feed the other end upward through the cell body. Hint: grasp the tubing with a small piece of #400 grit emery paper. Do not kink the tubing. Refer to Figure 5 for the proper orientation. Do not reverse the orientation as improper sampling will result. Install the cell body and screws.

5.

Feed the exit tube in through the rear of the Flow Cell. Press the exit tube over the steel tube.

3.2.5 Flow Cell Adjustment The Flow Cell must be adjusted after replacing the Flow Cell tubing, or any time the cell insert is removed or the adjustment set screw is disturbed. 1.

With the instrument on, lift the Flow Cell out of the read well. Do not unscrew the fitting.

2.

Press MENU. Type 189 and press ENTER. The instrument will continuously report the detector voltage at 405 nm. Record this value for reference below.

3.

Sample deionized water. Visually confirm there are no air bubbles in the cell window.

4.

Insert the Flow Cell into the read well until it bottoms out. Note the value displayed. If the displayed value is at least 1/2 of the value you recorded in step 2, no adjustment is needed.

5.

If the displayed value is less than 1/2 of the value in step 2, remove the Flow Cell. Adjust the set screw with the hex wrench supplied. Turn the set screw 1/4 turn in either direction and go to step 4. If the value in step 4 increases, turn the set screw in the same direction. If it decreases, turn the setscrew in the opposite direction.

6.

Repeat steps 4 and 5 until the displayed value is at a maximum. When complete, press CLEAR twice to return to the main prompt. You must read new water values as described in "Flow Cell Configuration".

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3.2.6 Valve tubing replacement It is not recommended to replace any tubing while the instrument is performing properly. However, the short length of silicone tubing used in the sampling valve may become clogged or worn with age. A replacement is included in the tubing kit. 1.

Set the power switch to OFF (O). Open the instrument as described in “Opening the instrument”. Refer to Figure 6-A. Locate the valve behind and to the right of the photometer.

2.

Refer to Figure 6-B. Pull back the pinch bracket and remove the valve tubing from the valve body.

3.

Disconnect the valve tubing from the fittings at both ends.

4.

Install the replacement tubing to the valve body in a similar manner. Push the tubing over the tubing barbs until seated. Be especially careful not to kink, stretch, or tension the tubing.

5.

Lower the cover and replace the screw.

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3.2.7 Waste Bottle Maintenance The following drawing of the waste bottle is to assist the user in noting any required replacement parts. Part numbers and descriptions are shown.

Figure 7- Waste Bottle Assembly

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3.2.8 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.

Before storing the instrument, clean the Flow Cell as described in "Cleaning". Store the instrument using the original packaging if possible. Perform the following steps before storing. 

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



Disconnect tubing and the sensor lead from the rear panel. Unhook the waste bottle strap and remove the waste bottle. Remove the waste bottle cap.



Empty the waste bottle and autoclave, or disinfect with a 1.5% chlorine bleach solution.



Remove the Flow Cell and allow the Flow Cell and waste bottle to dry overnight.



Place the instrument, Flow Cell, waste bottle 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. It is especially important to verify sample volume accuracy and photometric linearity before performing any clinical assays.

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4. TROUBLESHOOTING 4.1 Flags and Error Messages 4.1.1 Flags Flags are displayed to alert the operator when certain limits are approached. After displaying the warning the instrument will continue to function normally. Flags *****

printed in the concentration field if the absorbance is greater than 2.5 when using tubes, or greater than 3.5 when using the Flow Cell. To obtain an accurate absorbance and/or concentration for this sample it is necessary to further dilute the sample(s), or dilute the specimen(s) and rerun the assay.

>10**7

printed in the concentration column when the result of the concentration is greater than 7 digits and cannot be printed in the concentration column

—CURVE INVALID!!—

printed in the Multi-point mode when a curve cannot be drawn between the standards that were read. An “X” will be printed after the standard which causes the curve to be invalid. Check to make sure the standards were in decreasing order of absorbance in the Multi-point % Abs, or in increasing order if in Multi-point Mode. Since this invalidates the results, you should restart the test.

4.1.2 Error Messages Error messages are displayed when the instrument fails to operate correctly. They are intended to help the operator locate the problem. Error Messages Lamp Failure

The lamp does not appear to be sufficiently illuminated. This can be caused by either lamp failure or degraded filters. See the section “Lamp Replacement”. If replacing the lamp does not correct this, the instrument may require service to replace the filters.

Printer Paper Jam

The internal printer paper path is obstructed. The internal printer will be disabled, and you will be allowed to continue. Clear the paper path by gently pulling the obstruction from the printer, and restarting the instrument.

Printer Not Ready

The external printer attached to the parallel port or serial port is out of paper or otherwise unable to print.

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Error Messages (Continued) Waste is Full!!! XX

Displayed when the waste material has reached the level sensors. You have XX samples remaining until the instrument shuts down vacuum and pauses. Empty the waste bottle and replace the cap securely.

Empty Waste-Press Enter

The instrument has paused until you empty the waste bottle and press ENTER.

Sample Area Full!

Up to 255 samples are saved for reports. If there is no memory left for storing samples, this message is displayed. Subsequent samples are not stored. A message is printed on the report indicating data may have been lost.

MEMORY IS FULL

The instrument can not store the test because there is no available memory. Delete unused tests.

Check Vac System

The instrument detected an inability to achieve vacuum. Check the waste bottle cap and fittings.

The following messages may indicate an electronic problem with the main PCB. If these messages appear frequently, the instrument may require service: Memory Error

The checksum for a test that is being recalled is found to be invalid. The corrupted test is automatically deleted.

Filter Wheel Err

There is a mechanical problem with the instrument. Turn off the power switch, wait 15 seconds, then turn on the power switch.

Canceled

Displayed immediately following a filter wheel error to indicate that the test or mode has ended.

Filter Labels 7&8 Clrd!

The stored filter labels have been lost or corrupted. Refer to the section "Restore Filter Labels".

Water Values Reset

The Flow Cell is active and no water values were found in memory. The stored water values have been reset to 0.000. You must read new water values to ensure correct results. Refer to "Flow Cell Configuration".

Do Temp Test 210!

The stored temperature adjustment has been lost or corrupted. Refer to the section “Restore Calibration Data”.

Do ABS Test 212!

The stored absorbance adjustment has been lost or corrupted. Refer to the section “Restore Calibration Data”.

4.1.3 Incorrect control readings Check that the procedures and materials used were valid. Turbid or contaminated reagents may affect absorbance readings. Reading reference dyes can be very helpful in separating instrument problems from reagent problems. Be sure that you have selected appropriate wavelengths for the chromophore you are reading. Tubes should have no

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bubbles, condensation, scratches or smudges. 4.1.4 Poor linearity If the instrument is several years old, or has been operated in very humid conditions, you may need new optical filters. The instrument incorporates interference filters of an advanced technology, and will provide extended life in humid environments when compared to standard soft interference filters. However, excessive humidity should be avoided. The instrument will require service to replace the filters. 4.1.5 Erratic readings One possible source of erratic readings (excessive dither) is trapped air in the Flow Cell. This can be caused by improper installation of the Flow Cell tubing. Refer to the section "Flow Cell Tubing Replacement". Check the insertion depth of the Flow Cell tubes. Ensure that a leak-free seal is made. 4.1.6 Lamp failure The lamp is rated to read over 300,000 tubes, and the lamp saver feature minimizes lamp idle time. Lamp replacement is only indicated when the lamp fails to light, or when the message "Lamp output low!" is displayed. Press LAMP to turn the lamp on or off. If the lamp fails to light, refer to the section "Lamp replacement". 4.1.7 Pump runs continuously Ensure that the waste bottle cap is tight. Ensure that the tubing connections to the instrument rear panel are secure. Turn only until finger-tight. Do not over-tighten the plastic fittings. If the pump is taking longer to achieve full vacuum (runs much longer than usual), the exhaust filter is likely clogged and should be replaced. In the event that the filter gets wet due to a waste bottle spill, the filter must be replaced before continued operation. Contact your dealer for a replacement filter. 4.1.8 No sampling If you can hear the valve cycle, but no sample is drawn up, the valve tubing may be blocked. Press and hold PURGE several times. Disconnect the Luer fitting at the rear of the Flow Cell. Press PURGE and listen for aspiration. If you hear air entering the fitting, the valve tubing is clear, but the Flow Cell is blocked. Refer to the sections "Cleaning" and "Replacing Flow Cell tubing". If the valve clicks but the pump does not run when you press the PURGE key, the valve tubing may be stuck closed. If this happens, remove the front cover screw and lift open the cover. Pull the pinch bracket against the spring tension (to open the valve manually). Gently pull the tubing slightly to break the seal. See the section on “Valve Tubing Replacement” for a diagram and more information about the valve tubing.

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4.2 Restore Calibration Data 4.2.1 Restore Electronic Calibration Each unit is electronically calibrated at the factory. The calibration values are entered by the keyboard and stored in non-volatile memory. The instrument will not accept a change greater than +/- 10% (.900-1.100) for the absorbance factor, nor will it accept a temperature offset change greater than +/- 2.5°C. Only minimal calibration adjustments are accepted from the keyboard. Do ABS Set Test 212! Do Temp Set Test 210! If either of these messages are printed or displayed, it indicates that the calibration values have been lost. These messages will be printed each time that you turn on the instrument, select a mode, or recall a test. The instrument will continue to operate, but the calibration must be restored to ensure the accuracy of the instrument. WARNING: DO NOT ALTER ANY POTENTIOMETER SETTINGS! Changing these settings will make the factory calibration data invalid. In the unlikely event the calibration data is lost or corrupted, the absorbance factor is set to 1.000 and the temperature offset adjustments for the block and cell are set to 0.0. Do not enter values other than those recorded on the calibration label unless absolutely necessary. Follow these steps to restore the electronic calibration: 1.

Shut off the instrument. Remove any tubes or cuvettes from the incubation block and read well. Carefully lift up the instrument and locate the Calibration Data label on the underside of the unit. There are three values recorded there: Absorbance, Block Temp, and Cell Temp. Write down these numbers.

2.

Set the power switch to ON(1).

3.

If the date and time have been reset or are incorrect, enter the correct date and time. See the section “Set Date and Time”

4.

Press MENU, type in 210, and press ENTER. When the display shows "Block=", type the number that is recorded under the Block Temp heading on the calibration label, then press ENTER.

5.

The display will prompt “Cell=”. Enter the data from the Cell Temp line of the calibration label.

6.

Press MENU, type in 212, and press ENTER. When the display shows

7.



Abs Factor=



Enter the number from the Absorbance line of the calibration label. If the message “Adjust out of Range” is displayed, check the values and repeat this step.

Press MENU, type in 213, and press ENTER to get a report of the calibration data. The block and cell temperature adjustment will be printed along with the absorbance adjustment. Make sure that these values are the same as those recorded on the calibration label.

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4.2.2 Restore Filter Labels Like the calibration data, the wavelengths for the two optional filters are stored in non-volatile memory. In the event this data is lost or corrupted, the following message will be displayed and printed. Filter Labels 7&8 Clrd! You will need to re-enter the filter labels for two of the filters. Open the instrument and locate the filter label on the side of the photometer cover. Key 7 is xxx Key 8 is xxx where "xxx" is a three-digit wavelength value. If there are no 7th or 8th filters, they will be listed as BLOCKED. Press MENU, type in 248, and press ENTER. You will be prompted: Change Filter Names Key 7 = ??? nm Type in the wavelength for Key 7 that is printed on the label and press ENTER. Repeat for Key 8. You may use “000” for unused filter positions. Press CLEAR twice to return to the main prompt. Note that, if you enter values for Key 7 and Key 8 when there are no filters present, the filters will be flagged as “low” when Self Check is run.

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HUMAN Gesellschaft für Biochemica und Diagnostica mbH | Max-Planck-Ring 21 · 65205 Wiesbaden · Germany | Tel.: +49 61 22/99 88-0 · Fax: +49 61 22/99 88-100 | e-Mail: [email protected] · www.human.de