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HumaLyzer 3000 | User Manual

| Cat.No. 16700/1

Revision List of the Manual No. 1 2 3

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DATE / Rev. 03/2004-04 04/2008-09 05/2008-11

REVISION DESCRIPTION First edition Reformat Correction of small typing errors

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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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Contents 1 2 3 4 5

INTRODUCTION OPERATING PROCEDURES CLEANING AND MAINTENANCE TROUBLESHOOTING CONTACT INFORMATION

5 14 38 44 46

2/2

Contents 1

2

INTRODUCTION

5

1.1 Applications 1.1.1 Intended Use 1.1.2 Summary of the Instrument

5 5 5

1.2 Specifications

5

1.3 Warning Markings 1.3.1 Safety Symbols 1.3.2 Safety Terms

7 7 7

1.4 Safety Precautions

7

1.5 Setup 1.5.1 Unpacking 1.5.2 Installation/Preparation 1.5.3 Keypad Description

9 9 9 11

1.6 Checkout

11

1.7 Getting Started 1.7.1 Set Date/Time and Laboratory Name 1.7.2 Printer Set Up

12 12 13

OPERATING PROCEDURES

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2.1 General Selections 2.1.1 Flowcell Configuration 2.1.2 Lamp Warm-up and Lamp Saver 2.1.3 External Ports 2.1.4 Serial Port 2.1.5 PC Connection 2.1.6 Error Messages While Using the Parallel or Serial Ports 2.1.7 Units of Measurement 2.1.8 Entering Names 2.1.9 Ranges and Controls 2.1.10 Reports 2.1.11 Blanking 2.1.12 Reading Samples 2.1.13 Bichromatic Operation (Differential Filter)

14 14 15 15 15 16 16 16 17 17 20 21 21 22

2.2 Calculation Programs 2.2.1 Absorbance Mode 2.2.2 Single Standard Mode 2.2.3 Factor Mode 2.2.4 Multi-point Mode 2.2.5 Rate Mode

22 22 23 25 25 27

2.3 Stored Tests 2.3.1 Recalling a stored test 2.3.2 Listing stored tests 2.3.3 Deleting a test 2.3.4 Editing a test 2.3.5 Using WORKLIST

31 32 32 32 32 33

2.4 Special Features 2.4.1 Self-Check 2.4.2 Flags and Error Messages

33 33 34

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1 INTRODUCTION 1.1

Applications

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 wave-lengths. 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. 1.1.2 Summary of the Instrument HUMALYZER 3000 is designed for the investigation of Biochemistry Enzyme Immuno and Drug Levels from human serum, plasma, or urine. A removable Flowcell installs in the read well to provide extremely rapid fluid sampling with low carryover. A built-in vacuum pump and an external waste bottle with level sensing are sup-plied standard. When the Flowcell is removed, the instrument accepts standard 12 mm round tubes as well as 1 cm square cuvettes. The design of the instrument includes many features to minimise operator error, such as stable factory calibration, automatic zeroing, complete operator prompting, detailed labelling, pre-programmed calculations, visual and audible feedback, flags and error messages, and minimal maintenance requirements. The operating modes are: Absorbance Mode The HUMALYZER 3000 reads monochromatic or bichromatic differential absorbances at user-selected wavelengths. 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 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. Multi-point Mode Reports concentrations or percent absorbances based on the point-to-point connection of up to seven user-entered standards. In the Factor and Standard modes, differential samples (against sample blanks) are supported. Test parameters, and standard curves are stored in memory for later recall. The HumaLyzer 3000 stores up to 120 tests in memory to be recalled for later use. In addition, it will store 512 Patient Results, 512 Control Results, 20 Patients on Worklist, and 15 tests per patient. 1.2

Specifications

Specification Date Model Name Spectrophotometer Type Optical Configuration

Usable Spectral Range System Procedures Calculating Modes

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22 May 2003 HumaLyzer 3000 Filter photometer Single beam with continuously rotating filter wheel Monochromatic or bichromatic reading 8 filter positions 330 to 670 nm Open and by stored menu 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

Channels Source of Radiation Selection of Wavelength Filter Type Wavelength Accuracy Filter Location Filter Selection Wavelengths Half Bandwidth 1/100 Bandwidth False Radiant Energy Ratio Cuvette Supplied Type Material Geometry Illuminated Volume Minimum Read Volume Aspiration/Purge Valve Cuvette Holder Detector Signal Processing and Display Display Type Scale of Display Absorbance Concentration Kinetic Results Zero Compensation Range Signal Outputs Parallel Serial Data Input Spectrophotometric Inaccuracy Flow-through

Stability Warmup Time Electronics

Power

Fixed Time Kinetic By Factor or by Standard 44 Pre-Configured, 76 Open Tungsten Halogen, 10 Watt, with automatic lamp saver By filter 4-cavity interference, long-life ion beam-assisted deposition +/- 3 nm After sample (heat absorbing filter before sample) Automatic by software or via keyboard 340, 405, 505, 545, 580, 630 nm supplied standard other/additional filters optional < 10 nm 14 nm at 340 nm < 0.001 at 340 and 405 nm 1 cm square, 12 cm round, flow through Flow-through 316 stainless, borosilicate windows Cylindrical, 2.3 mm dia x 5 mm +/- 0.05 mm 21 µl 250 µl Vacuum pump at 18 cm of Hg Silicone pinch type Thermostatically controlled compartment at 37° C Gallium-Arsenide-Phosphide photodiode 240x128 Graphic LCD w/ Backlight -0.5 to 3.5 (flow-through mode) -0.5 to 2.5 (tube or 1 cm cuvette) Maximum 999,999 Abs/min with resolution of 0.0002 A/min Automatic -0.5 to 2.5 absorbance Centronics/IBM-PC compatible RS-232 at 9600 baud, 8 data, 1 stop, no parity Bi-Directional 1) 20 Key Keypad, 2) PS2 101 Keyboard (connector available at back of instrument) < 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 Better than 0.003 A/hr monochromatic after warm-up Better than 0.001 A/hr bichromatic after warm-up 90 seconds photometric 15 minutes for temperature compartment Z180 Microprocessor 18 MHz 128k eeprom 32 K bytes Nonvolatile RAM (NVRAM) Auto-Switching Power Supply Voltage source: 100 - 240 VAC Frequency: 50/60 Hz Power consumption: 90 watts Installation Category: CAT II

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Dimensions and Weight Space Requirements Environmental Conditions for Safe Operation:

Recommended Operating Temperature Recommended Operating Humidity 1.3

Fuses: PS-25-5 Power Supply: 2.5A/250V Fast 5-20 mm (glass) LPT 45 Power Supply: 2.5A/250V Fast 5-20 mm (ceramic) Main AC Supply: 6/10 250V Slow Blow 3AG 43cm (L) x 39cm (W) x 15cm (H) Lid closed, (32cm Lid opened), 7.5 kg 10 cm clearance on all sides

Indoor Use. Temperature 5°C to 40°C. (Although it may be safe to operate in these conditions, it may not be suitable for the performance of the user’s tests. Check with supplier.) Humidity 85% for temperatures up to 31°C decreasing linearly to 50% humidity at 40°C. Mains supply voltage fluctuations not to exceed ±10% of the nominal voltage. 15-35°C Between 10 and 85%, non-condensing

Warning Markings

1.3.1 Safety Symbols Safety symbols which may appear on the product:

WARNING Risk of Shock

Protective Ground (Earth) Terminal

CAUTION Refer to Manual

BIOHAZARD Risk of infection

FUSE: For continued protection against the risk of fire, replace only with fuse of the specified type and current ratings. Disconnect equipment from supply before replacing fuse. 1.3.2 Safety Terms These terms may appear on the product: DANGER indicates an injury immediately accessible as this marking is read. WARNING indicates an injury hazard not immediately accessible as this marking is read. CAUTION indicates a hazard to property including the product. Terms which may appear in this manual: WARNING: Warning statements identify conditions or practices that could result in injury or loss of life. WARNING indicates an injury hazard not immediately accessible as this marking is read. CAUTION: Caution statements identify conditions or practices that could result in damage to this product or other property. BIOHAZARD: Biohazards are biological agents that can cause disease in humans. Lab workers handling potentially infectious materials must use universal precautions to reduce the risk of exposure to these agents. 1.4

Safety Precautions

To assure operator safety and prolong the life of the instrument, carefully follow all instructions outlined below. Read Instructions Review the following safety precautions to avoid injury and prevent damage to this instrument or any products connected to it. To avoid potential hazards, use this instrument only as specified. For best results, become familiar

7 Human HumaLyzer 3000 User Manual

with the instrument and its capabilities before attempting any clinical diagnostic tests. Refer any questions to your instrument service provider. Servicing There are no user-serviceable parts inside the instrument. Refer servicing to qualified service personnel. Use only factory authorised parts. Failure to do so may void the warranty. Personal Protective Equipment Many diagnostic assays utilise materials which are potentially biohazardous. Always wear protective apparel and eye protection while using this instrument. Follow Operating Instructions Do not use the instrument in a manner not specified by the manual or the protection provided by the instrument may be impaired. Use Proper Power Cord Use only the power cord specified for this product and certified for the country of use. Ground the Product This product is grounded through the grounding conductor of the power cord. To avoid electric shock, the grounding conductor must be connected to earth ground. An alternate method is to attach a ground strap from the external grounding terminal on the rear panel of the instrument to a suitable ground such as to a grounded pipe or some metal surface to earth ground. Observe All Terminal Ratings To avoid fire or shock hazard, observe all ratings and markings on the instrument. Consult this manual for further ratings information before making connections to the instrument. Install as Directed The HumaLyzer 3000 should be installed on a stationary flat working surface capable of supporting the instrument’s weight (10 kg) safely for safety and ventilation purposes. The mounting surface should be at least 61 cm deep and free of vibrations. Provide Proper Ventilation Refer to the installation instructions for details on installing the product so it has proper ventilation. The instrument should be surrounded by the following clearances: 10 cm around perimeter of unit and 10 cm on top. Do Not Operate Without Covers Do not operate this instrument with covers and panels removed. Use Proper Fuse Use only the fuse type and rating specified by the manufacturer for this instrument. Use of a fuse with an improper rating may pose a fire hazard. Avoid Exposed Circuitry Do not touch exposed connections and components when power is present. Avoid Excessive Dust Do not operate in an area with excessive dust. Do Not Operate With Suspected Failures If damage is suspected to this instrument, have it inspected by a qualified service person. Do Not Operate in Wet/Damp Conditions. Do Not Operate In An Explosive Atmosphere. Keep Instrument Surfaces Clean and Dry Solvents such as acetone or thinner will damage the instrument. Do not use solvents to clean the unit. Avoid abrasive cleaners; the display overlay is liquid-resistant, but is easily scratched. The exterior of the instrument may be cleaned with a soft cloth using plain water. If needed, a mild all-purpose or nonabrasive cleaner may be used. A 10% solution of chlorine bleach (5.25% Sodium Hypochlorite) or 70% isopropyl alcohol may be used as a disinfectant. Take special care not to spill liquid inside the instrument. Operating Precautions Be sure to run a sufficient number of controls in each assay. If controls are not within their acceptable limits, disregard test results. Biohazard Precautions

BIOHAZARD

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WARNING: If the Waste bottle is overturned during operation, immediately set the power switch to OFF (0). If this occurs, the instrument may discharge a small amount of waste material from the waste bottle via the fitting on the bottom of the instrument. This material should be treated as potentially biohazardous. Appropriate clean up of the material should be observed. 1.5

Setup

1.5.1 Unpacking Carefully unpack the instrument, removing it from its plastic bag. Report any damage to your freight carrier at once. Retain the original packing material for future use in the event that the instrument is shipped to another location or returned for service. The following items should be packed with the instrument. Please locate each item now before continuing. Included items Heat Block Waste bottle Cleaning solution Bottle cap assembly Paper rolls Power cable Serial cable Flowcell Tool Kit and Spare tubing Valve tubing Sample tube, long Exit tube Tube gasket Tubing gripper Hex wrench Operator’s Manual

Description External Incubation Block Plastic bottle Plastic bottle containing Flowcell cleaning solution Bottle cap, tubes, sensor wires (2) Thermal printer paper Heavy cord RS232 ”T”-shaped object with square extension, in plastic box Silicone tube Teflon tube, swaged end, for sample Teflon tube with male Luer attached Foam rectangle with round hole Rectangle of emery paper 1.6 mm This document

Contact your distributor if anything is missing. 1.5.2 Installation/Preparation Complete this procedure to prepare the instrument for operation. Instrument placement and Use - Place the instrument on a flat working surface capable of safely supporting the weight of the instrument, approximately 10 kg (22 lbs.). A clearance of at least 10 cm (4”) around the instrument is required to assure optimal ventilation. 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. Figures 6 A & B (located in the section “Valve tubing replacement”) shows a diagram of the valve tubing location. Replace the cover and continue. 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. Connect the waste bottle tubes to the rear panel fittings. The tubing connections are colour-coded; match the male Luer cap to the colour-coded ring on the rear panel. The vacuum line fittings are blue and the waste line fittings are black. Turn the fittings clockwise only until finger-tight. Do not over-tighten. Plug the sensor lead into the sensor jack on the rear panel. 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. Power Switch Position - When installing the power cord the unit should be turned off. Look at the rear panel of the instrument to check that the power switch is in the OFF (O) position. Power Cord Requirements - 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. Use only the power cord specified for this product and certified for the country of use. For 110-120 V units used in the US, use a UL listed cord set consisting of a minimum 18 AWG, Type SVT or SJT three conductor cord, maximum 3 meters (10 feet) in length, rated 10 A, 125 V, with a parallel blade, grounding type attachment plug.

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For 220-240 V units used inside the US, use a UL listed cord as above, except rated 250 V, with a tandem blade, with grounding type attachment plug. The cord set provided by the manufacturer meets these requirements. For other locations, use the power cord certified for the country of use. Safety Grounding - Do not alter or defeat the safety grounding methods provided. To avoid the risk of electric shock, the third prong of the AC power plug must be connected to conductive parts internal to the equipment. Internal fasteners to grounding points are marked by the IEC 417 symbol 5019. DO NOT loosen or remove these fasteners or connections. An alternate method of grounding is provided by connecting the grounding terminal located on the rear panel to a suitable ground. To avoid electric shock, the power cord protection ground conductor must be connected to ground. Assure Clean Power Availability - The circuit used should be substantially free of large voltage transients (Kilo-volt amp loads) such as large pumps, large centrifuges, refrigerators and freezers, air conditioners, large auto-claves, ovens, and dryers. The instrument may fail to operate normally if the power supply is interrupted. If this occurs, turn the instrument off for a moment. When the instrument is turned back on, it will resume normal operation, but data that was not stored in nonvolatile memory will be lost. Fuse Requirements - The fuses are located inside the instrument; there is a fuse in both power supplies and one in the Main AC Supply. Fuse failure is a very rare occurrence and should indicate malfunction of the equipment requiring service by qualified personnel. The power supply mounted on top requires a 2.5A/250V Fast 5-20 mm Glass Fuse. The power supply mounted to the chassis requires a 2.0A/250V Fast 5-20 mm Ceramic Fuse. The Main AC Supply requires a 6/10 250V Slow Blow 3AG Fuse WARNING: For continued protection against risk of fire, always use the specified fuse for replacement. Disconnect power cord from mains supply before replacing fuses. Inserting the Flowcell: Note: Use extreme caution as forcing the Flowcell to seat improperly may dam-age it or the instrument. Insert the Flowcell in the read well so that the sample tube is toward the front. Press the Flowcell gently down and towards the rear into the read well. Verify that the Flowcell is seated firmly. Set the power switch at the right rear of the instrument to ON (1). The display shows:

Cell Temp.

Heat Block Temp.

Ext. Keyboard

Lamp

Flowcell

Vacuum Pressure

Heating

Lab Name (User Specified)

Note: The External Keyboard icon will appear only after a key on the external keyboard has been pressed. The printer will print several lines. Wait until it has stopped. (If there is no printing, the internal printer is disabled. Refer to Printer Set-Up 1.7.2 in this manual.) To load paper: Locate the roll of printer paper. Roll out 15 cm (6”) of paper from the roll. Be sure that the leading edge of the paper is straight. Cut the edge of the paper straight across with scissors if necessary. Feed the leading edge of the paper into the slot inside the printer paper compartment. While feeding the paper as de-scribed, press the PAPER key repeatedly until the paper “catches” and begins to feed into the printer. When the printer paper exits at the top of the printer, stop pressing the PAPER key. The paper may be pulled through to help with alignment. Place the paper roll into the printer well. Using the Flowcell: To aspirate using the Flowcell, activate the Sample Sensor. The Sample Sensor is the square hole directly below the Flowcell. This is activated by interrupting the beam with a finger, pencil, or other object.

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Clean the Flowcell: Press the TOOLS (F4) key. Select 2 in the corresponding menu to enable Flowcell. Locate the bottle of Flowcell cleaning solution. Open the bottle and position it so that the sample tube is immersed in the solution. Activate the Sample Sensor to aspirate cleaning solution into the Flowcell. Remove the bottle of cleaning solution and replace the cap. Allow the solution to remain in the Flowcell for 3 minutes. Position a container of distilled water so that the sample tube remains immersed. Activate the Sample Sensor to aspirate water into the flow cell. (The flow cell activates using an optical sensor in the notched out are behind the aspiration tube.) Allow the water to remain in the Flowcell for 3 minutes. Purge: Activate the Sample Sensor and continue with the interruption of the beam until no more liquid can be seen flowing into the waste bottle. (During sampling, the instrument will purge automatically between samples.) Set the power switch to OFF (O) and continue to the section “Checkout”. 1.5.3 Keypad Description Refer to Figure 1, Keypad Layout. The Function keys (F1 through F4) correspond to the four keys shown at the bottom of the screen in the same order. For example, in the opening screen, F1 = Run Test, F2 = Program, F3 = Worklist, F4 = Tools. When applicable, the Enter key on the main keypad performs the same function as the Enter Function key shown on the screen. Lamp: Toggles the lamp on or off. Line Feed: Internal Printer, feeds one line at a time; External Printer, skips one line. Form Feed: External Printer, initiates the printer to print all data stored in its internal memory.

Figure 1. Keypad Layout 1.6

Checkout

Follow this procedure to verify that the instrument is ready for use. In this procedure, it is assumed that the Flowcell is being used. If using the instrument with tubes or square cuvettes, disregard the Flowcell 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.  Flowcell is fully seated in read well and Luer fitting is connected (if Flowcell is in use.)  Heat Block is connected.  External Keyboard is connected. (If applicable)  Power switch is set to OFF (O).

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The instrument is now ready for power-up. Confirm that the instrument responds as described.  Set the power switch at the right rear of the instrument to ON (1). The display will show:

The printer will print a header containing the instrument model, software revision, laboratory name, and the date and time. (If the Flowcell is disabled, “V = #.#” on the status line would read “Tube”.) HumaLyzer 3000 v. A DD/MM/YY HH:MM The letters following “v.” indicate the software revision. If the date and time are incorrect, set the date and time as described in section 1.7.1 “Set Date/Time”. Allow the instrument to equilibrate for at least 15 minutes. The read well must be at 37°C. See section 2.1.3. If the instrument produces results other than those described here, set the power switch to OFF (O). Refer 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. 1.7

Getting Started

1.7.1 Set Date/Time and Laboratory Name Press the F4 Key (Tools). The display shows the following options: 1 = Stored Data Utilities: This is where the User Test Data Menu, the Control Data Menu, and the Patient Result Data Menu are located. 2 = Flowcell Configuration: Turn Flowcell “Off” to use Tubes or cuvettes, “On” if using Flowcell. 3 = Printer Setup: This allows the user to set up either the internal or external printer. 4 = Diagnostics Menu: This is where the Filter Voltages, Filter Wheel Speed, Absorbance Calibration, Temperature Calibration, and Current Vac, Temp, Waste Count are found. Also a Self Check, shown below (see Sec. 2.4.1): 5 = General Configuration: This is where the operator will set User Specific Options. Press 5. The next screen offers four options. “Set Date and Time”, “Enter Laboratory Name”, “Delete Laboratory Name”, “Cell Heat Control”, or “Block Heat Control”. 1 = Set Date and Time: This screen will ask to choose a Date Format. Choose 0 for MM/DD/YY or 1 for DD.MM.YY (Eurodate format), and press Enter. Note: If using a Chinese instrument, the date is fixed YY.MM.DD Enter the Date as month, day, and year (or day, month, year in Eurodate format) using two digits each and separating the entries with the decimal point, then press Enter. Enter the time as hour, minute, and seconds using two

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digits each and separating the entries with the decimal point, then press Enter. Use “13” for 1 PM, “14” for 2PM, etc. 2 = Enter Laboratory Name: To enter the Laboratory Name, see section “2.1.8 Entering Names” in this manual. 3 = Delete Laboratory Name: Press 3 and the Laboratory Name is deleted and the user is returned to the TOOLS menu. 4 = Cell Heat Control: Press 0 and Enter to turn the Heat Cell “Off”, 1 to turn it “On”. The temperature of the read well is displayed at the top of the screen continuously no matter what mode the instrument is in. The temperature of the cell is automatically controlled to 37°C by the software. 5 = Block Heat Control: Press 0 and Enter to turn the Heat Cell “Off”, 1 to turn it “On”. Allow at least 15 minutes for the instrument to equilibrate after enabling or disabling cell or block temperature control. When installing a room-temperature cuvette or the flowcell 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 flowcell to equilibrate after insertion. Note: Even with temperature control disabled, the ambient temperature of the cell is somewhat higher than room temperature. 1.7.2 Printer Set Up The instrument has a built-in 40 column thermal graphics printer that is used to list information and provide a record of the samples. There are two ports, a parallel and a serial port on the rear of the instrument that communicate the same information that is sent to the internal printer. Select either, both or neither of the printers or ports. The data is output to both printers or ports in the same format. When connecting an additional printer or an external PC, the instrument must be switched off. After the connection is made, turn the instrument on again. Enable the EXTERNAL Printer. This will also enable the serial port. To advance the paper or send a line feed, press Line Feed. The line feed advances. Press F4 (Tools). At the “Instrument Tools” screen, select 3 “Printer Setup”. Choose the Printer type. To select the HumaLyzer 3000’s Internal Printer, select 1. If using an External Printer or serial port, select 2. The third selection is 3 - Internal Printer Font Sample. This prints a list of characters in both draft and letter in the five available contrast settings on the internal printer. 1 - Internal: The display shows:

Internal Printer Status (F1): The current status is highlighted. Press F1 (STATUS) to toggle to the desired status. Internal Printer Contrast (F2): The current contrast setting is highlighted. To move to the desired setting, press F2 (CONTRAST). Keep in mind that the lighter settings print faster. Internal Print Quality (F3): The current quality setting is highlighted. Letter is a higher quality print, but much slower on print time. Press F3 (QUALITY) to toggle between the two selections. Once these selections are made, press COMPLETE (F4) to return to the instrument tools page.

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External: The display shows:

External Printer Status: Shows current status. Use F1 (STATUS) to toggle to chosen Status. Current Maximum Lines per Page: Shows current number. To change this number, Press F2 (LINES/PG) and enter the number. Press Complete to return to the instrument tools menu. 2 OPERATING PROCEDURES 2.1

General Selections

2.1.1 Flowcell Configuration Flowcell Configuration offers 2 choices; read tubes and cuvettes, or activate the Flowcell with options to change the aspirate (sample) volume, and read and store water reference values. From the Main Menu, press F4 (TOOLS). Then press 2, “Flowcell Configuration”, Enter. The display shows:

Press F1 (STATUS) to change Flowcell status, in this case to “On”. The Flowcell immediately turns on and “ON” is highlighted. To change the volume sampled, select F2 (VOLUME). The display shows:

Choose the number which corresponds with the desired volume. For instance, type 0 for the volume 750, then Enter. The display shows the Flowcell configuration menu. The Current Sample Volume reflects the chosen volume.

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To Calibrate the Flowcell, press F3 (CAL MENU). The display shows:

Note: These options may only be used if the Flowcell is active. 1=Read Water Reference: The instrument references water instead of air when reading with the Flowcell. These reference values are stored in non-volatile memory and are used whenever the Flowcell is active, until new values are read. This should be done before Flowcell Alignment. 2=Flowcell Alignment: Choosing 2 and Enter shows the Flowcell Alignment Screen. First, the Flowcell should be active but NOT inserted into the read well. Press F3 (PRINT) to print the current reading. Insert the Flowcell into the read well. Submerge the end of the tubing into a container of water and activate the Sample Sensor. The sample sensor should be held until water starts to flow into the Waste Bottle. This will decrease the likelihood of air bubbles interfering with an accurate reading. This reading should be slightly over half of the original reading. If it is not, the Flowcell must be adjusted. If the displayed value is less than 50% of the reading with the Flowcell removed, purge and remove the Flowcell. Adjust the set screw with the hex wrench supplied. Turn the set screw 1/4 turn in either direction and replace the Flowcell. Sample water again. If the value increases, turn the set screw in the same direction. If the value decreases, turn the setscrew in the opposite direction. Repeat until the value is >50%. When complete, press ENTER to return to the previous prompt. New water values must be read as described above in Read Water Reference. 2.1.2 Lamp Warm-up and Lamp Saver The lamp must warm up before any readings can be taken. As soon as the lamp is turned on the warm-up time begins and continues to count down. If a test is selected very quickly, the instrument will pause until the warm-up time has elapsed. The message Lamp Warm-up:XX Secs is displayed and the time XX will count down to zero. When the warm-up 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. Select a test or mode, or press LAMP to turn the lamp on. 2.1.3 External Ports An external printer may be connected to the parallel port on the rear of the unit. Any IBM compatible printer and standard parallel cable may be used with the parallel port. The serial port on the HumaLyzer 3000 is MultiDirectional (transmits and receives data). The receiving device may momentarily stop the transmission from the instrument. It will resume automatically when the receiving device is ready. If the receiving device does not have a large enough buffer, the HumaLyzer 3000 times out and the “Ext Printer Not Ready, Retry Y/N?” error message appears on the display. This error message refers to any receiving device (printer, PC, external serial or parallel ports). 2.1.4 Serial Port By using a standard RS232 Cable (Null Modem Serial Cable), a computer with a serial port may be connected. The data format is 9600 baud, 8 bits, 1 stop bit, and no parity. Contact your distributor to obtain a serial printer cable.

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2.1.5 PC Connection The serial port pinout has been reconfigured to allow direct connection to a PC. The output may be viewed on a PC by using a program such as HyperTerminal once the communications protocol in the program has been set to the HumaLyzer 3000 data format. 3 TD (TRANSMIT DATA output) 5 GND (SIGNAL GROUND) 8 CTS (CLEAR TO SEND input) SEE 2.1.6 for more Info. 2.1.6 Error Messages While Using the Parallel or Serial Ports If the external printer or PC is enabled, and the printer or PC is connected but is off-line, an error results only when the instrument attempts to communicate when in a mode. The instrument stops and displays “serial receiver not ready” until the problem is corrected. In the event that the external printer or PC 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 to “Retry”. Press YES to continue to output after the printer or PC has emptied its buffer, or NO to turn off communication to external ports. 2.1.7 Units of Measurement In all modes except Absorbance Mode, the option of selecting units of measurement is given. Units are provided to label the calculated concentrations, but have no bearing on the actual calculation. The display shows:

Press “MORE” (F2) to see the rest of the choices:

Press the numeric key that corresponds to the choice and ENTER. The units for that code are displayed. To confirm the choice press YES. To select a different unit, press NO and a different numeric key.

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2.1.8 Entering Names It is sometimes necessary to enter an alphanumeric name. For instance, user tests and controls can be named, and the laboratory name shown in the header may be changed. When prompted for a name, the following display is shown if no external keyboard is connected:

The cursor is the small triangle beneath the “A” on the top line. Press 4 to move the cursor to the left, 6 to move the cursor to the right, 2 for up, or 8 for down. When the cursor is beneath the first letter of the chosen name, press SELECT. The bottom line clears and shows the selected letter. Continue using the 2, 8, 4 and 6 keys and SELECT to select each letter in the name. When complete, press COMPLETE. To remove a letter from the end of the name, press F2 (Back Sp.). To cancel and return to the main prompt, press QUIT. The HumaLyzer 3000 offers the option of using an External Keyboard. If it is plugged in before turning instrument On, the External Keyboard is automatically activated by pressing any key. If the External Keyboard is active, each time the instrument prompts the user to “Enter Name”, the External Keyboard alone will be used and the KeyPad screen (shown in this section) will not appear. The External Keyboard’s key usage limitations are listed as follows:  Any letter or number key are available for data entry.  The F1 - F4 keys work the same way that the F1 thru F4 keys work on the keypad.  The Shift or CAPS LOCK keys can be used to change the case of the characters.  Windows Specific keys have no function. (i.e. Ctrl, Alt, Tab, Esc, etc.) 2.1.9 Ranges and Controls In all modes except Absorbance Mode, the user has the option of entering ranges and / or controls. The display will show:

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Press “1” (Set Up Ranges). The display shows:

If applicable, enter the Blank Abs. Min and Max values. In this example, those values were skipped (Any value can be skipped by simply pressing ENTER). Enter the concentration limits for the Normal Range and Linear Range. The display will show:

The user may also change any of the values by using the CLEAR (F3) key or the ARROW (F2) Key. When the instrument takes a reading, a word indicating the range (none, LOW, HIGH, OUT) is shown to the right of the concentration on both the display and the printer. None: The concentration is within the normal range. LOW: The concentration is lower than the Minimum value of the Normal range, but within the linear range. HIGH: The concentration is higher than the Maximum value of the Normal range, but within the linear range. OUT: The concentration is outside the Linear range. If finished, press ENTER when COMPLETE is highlighted. The user is returned to the Results Parameters Setup Menu. Press 2 to Setup controls. The instrument allows the user to enter and name up to 3 controls per test. Controls are designated samples with specified concentration ranges that provide a reference for comparisons. The display shows:

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Select 1, 2 or 3 and Enter to choose the desired control type. A Normal control is used in this example. Select 1. The display shows:

From this menu, if F1 (QUIT) is chosen, the instrument returns to the Main Menu and quits the test. Press F4 (Disable) and return to the Result Parameters Setup Menu. If F3 (ENABLE) is selected, the instrument prompts to “Enter Normal Control Name”. (For more information, see section 2.1.8 Entering Names.) Once completed, the user is prompted to “Enter Normal Control Lot Number”. Enter this number in the same way. Once complete, the instrument prompts to “Enter Normal Control Expiration Date:” Using the keypad or key-board, enter the expiration date in the MM.YY format. For instance, if the expiration date is “September 2007” the user will enter “09.07”. When finished, press F4 (ENTER). The display will prompt you to enter a Low Range Limit. Enter the Low Range and press Enter. Then input the High Range and press Enter. The display now shows:

The user should understand that in all selections except #4, passing control data is saved. Select the number which corresponds with the reaction that should be taken in the event of a failed control and press Enter. The display will return to the Control Selection menu. Select another control or press 4 to return to the Result Parameters Setup Menu. Control results can be saved and used later to generate a Levey-Jennings report. (See section 2.1.10 Reports for more info.) When finished, select 3, Setup Complete.

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2.1.10 Reports The instrument provides reports to the printer, internal and / or external, showing the stored patient data and interpretations along with logged information such as the test name, date and time, and includes space for laboratory information. Patient data is stored and retrieved by patient name, and there is room for a total of 512 results. To print a report: At the end of shift or reporting period, press QUIT so that the instrument displays the main prompt. Press F4 (TOOLS). Press 1. The display shows:

1 = Stored User Test Menu: Press 1 and the display shows:

Press 1 to Print a menu of all of your stored tests. Press 2 to Delete all of your stored tests. Press 3 to Delete one of your stored tests. Press 4 to Edit one of your stored tests. Press 5 to Download your tests from a connected PC. (See section 2.4.1 for info) Press 6 to return to Stored Data Utilities Menu.

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2 = Stored Controls Menu: Press 2 and the display shows:

Press 1: Press 2: Press 3: Press 4:

Enable/ Disable controls in your stored tests by selecting the test number. Deletes all stored control results. Deletes stored control results by test and lot #. Prints controls stored in a test by a chosen test #. It prints Test #, Control Data, Lot Number, Type Name, and Result. Press 5: Creates a Levey-Jennings Report using a selected test and control results. Press 6: To return to Stored Data Utilities Menu. 3 = Stored Patient Result Menu. Press 3 and the display shows:

Press 1: Print a patient report by a Patient ID you select. Press 2: Delete all of a patients results by ID. Press 3: Delete all results for a selected test #. Press 4: Delete ALL stored patient results. Press 5 to return to Stored Data Utilities Menu. Press F1 (QUIT) to return to the main menu. 2.1.11 Blanking The instrument prompts 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 Flowcell mode, it is relative to the stored water values. In this way the user can evaluate the suitability of the blank before using it. By pressing the “BLANK” key, blanking can be done anytime and as many times as the user chooses. 2.1.12 Reading Samples Using tubes or cuvettes: The instrument prompts 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, the tube may be removed. The instrument prompts to insert the next tube.

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Using the Flowcell: The READY indicator on the front of the instrument will light and the display will prompt 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. Activate the sample sensor. The instrument will automatically sample the pre-set amount. Remove the sample container from the sample tube after the instrument beeps. When the reading is complete the sample will be automatically purged from the Flowcell and drawn into the waste bottle at the rear of the instrument. When the instrument is ready for the next sample, the READY indicator lights, and the instrument prompts to read the next sample. 2.1.13 Bichromatic Operation (Differential Filter) The instrument allows the user to read bichromatically with no increase in read time. Use the instrument bichromatically whenever possible, especially in Rate Mode. The absorbance at the differential wavelength is subtracted from the absorbance at the primary wavelength. Whenever possible, differential (bichromatic) reading is recommended because precision is significantly improved by removing the effect of optical imperfections and nonuniform wall thicknesses when using disposable plastic cuvettes or glass tubes. In order to preserve sensitivity, it is important to choose a differential wavelength for which the chromophore being assayed exhibits minimal absorbance. Wavelength 340 405 505 545 580 630

Chromophore UV purple blue green emerald green yellow red

To test your chromophore, read a darkly coloured solution in the absorbance mode at the operating wavelength with no differential filter, and again at the operating wavelength with the differential filter selection. If the two absorbance readings are within 10% of each other, then bichromatic differential reading is beneficial. If the difference between the absorbance readings with and without a differential wavelength is greater than 25%, then the chromophore is absorbing at or near the differential wavelength and bichromatic reading at this wavelength is probably not desirable. If no bichromatic wavelength is selected, exercise every measure to enhance repeatability. Choose a better quality reading vessel and wipe fingerprints from each tube before reading. Mark each tube for uniform orientation when multiple readings are desired. Determine the acceptability of the precision by reading the same tube several times and observing the variation of the readings. Depending on the precision requirements of your assay, monochromatic reading may or may not be acceptable with certain plastic tubes.  Wipe any dust, moisture, or fingerprints from the tubes before using.  Do not read tubes that contain bubbles or condensation.  Use a blank material with absorbance of less than 0.400A.  Use the same type and size of tube for the blank and samples. 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. Press PROGRAM (F2). Select 1 and ENTER. The Select Filter Screen will be shown. PRIMARY FILTER is Highlighted Press the numeric key that corresponds to the desired wavelength. To confirm the choice, press ENTER. The selected wavelength is highlighted. DIFFERENTIAL FILTER is then Highlighted. Select the differential wavelength or press 0 to read monochromatically and press ENTER. The Wavelengths are then printed. The next two options are first to save the test and then to name the test. If yes to saving the test, the option will then be given to name the test. When a test is saved, it will always be saved as the next available number. 1, 2, 3, 4, etc. After naming the test and pressing COMPLETE, display shows: Saving Test #

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Then gives the test number, then the name the user saved it as. If it is the first saved test and is named HIV, the display and printout will show: Saving Test # 1 HIV If in tube mode, the instrument now makes an air reference reading. If Flowcell is active, it uses the stored reading. The display then shows:

Insert the blank tube or sample the blank material. See the section “2.1.11 Blanking” for details. When finished reading, remove the tube or sample the material. Re-blanking may be done at any point by pressing BLANK. The display shows:

Remove the sample and repeat as necessary. To exit Absorbance Mode and return to the main prompt, press QUIT (F1). The instrument prints “Test Ended” and returns to the main prompt. 2.2.2 Single Standard Mode In Single 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. Press PROGRAM (F2). Select 2. The display shows: Standard Mode Differential Samples? 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 not using differential samples, press NO to continue. The Select Filter Screen will be shown. Primary Filter is Highlighted Press the numeric key that corresponds to the desired wavelength. To confirm the choice, press ENTER. The selected wavelength is highlighted. Differential Filter is then Highlighted. Select the differential wavelength in the same way the primary wavelength was chosen and press ENTER. The Wavelengths are then printed.

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The display shows:

Enter the value of the standard and press ENTER. To clear a mistake and re-enter the factor press CLEAR. The standard concentration is then printed. Note: The instrument will accept a factor which is up to seven digits, and there can be up to (2) decimal places. The instrument then prompts for a unit of measure to be entered. Enter the unit’s code (0-13) and press ENTER. See the section “2.1.7 Units of Measurement” for details. The entire list of Units is displayed. Type in the corresponding number and press ENTER. The display then shows the selected unit. Press YES to accept. The Result Parameters screen is then shown prompting the user to set up Ranges and Controls. See section 2.1.9 Ranges and Controls for more on this option. The next two options are first to save the test and then to name the test. If yes to saving the test, the option will then be given to name the test. When a test is saved, it will always be saved as the next available number. 1, 2, 3, 4, etc. After naming the test and pressing COMPLETE, Display shows: Saving Test # Then gives the test number, then the name the user saved it as. If it is the first saved test and is named HIV, the display and printout will show: Saving Test # 1 HIV If the instrument is in tube mode, it displays “Referencing Air” and makes an air reference reading. In Flowcell mode, the stored water values are used as a reference. Insert the blank tube or sample the blank material. See the sections “2.1.14 Blanking” and “2.1.15 Reading Samples” for details. The display shows:

Insert the standard tube or sample the standard material. See the section “2.1.15 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 was specified. The Standard Reading calculated factor will be printed. Repeat as necessary. Re-Blanking may be done at any point by pressing BLANK. To exit Standard Mode and return to the main prompt, press QUIT. The printer outputs “Test Ended”, and the instrument returns to the main prompt.

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2.2.3 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. Press PROGRAM (F2). Select 3. The display shows: Factor Mode Differential Samples? 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 not using differential samples, press NO to continue. The Select Filter Screen will be shown. Primary Filter is highlighted. Press the numeric key that corresponds to the desired wavelength. To confirm the choice, press ENTER. The selected wavelength is highlighted. Differential Filter is then Highlighted. Select the differential wavelength in the same way the primary wavelength was chosen and press ENTER. The Wavelengths are then printed. Enter the Factor when prompted and press ENTER. To clear a mistake and re-enter the factor press CLEAR. When ENTER is pressed, 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 up to (2) decimal places. Enter the unit’s code (0-13) and press ENTER. See the section “Units of Measurement” for details. The entire list of Units is displayed. Type in the corresponding number and press ENTER. The display then shows the selected unit. Press YES to accept. The Result Parameters screen is then shown prompting the user to set up Ranges and Controls. See section 2.1.9 Ranges and Controls for more on this option. The next two options are first to save the test and then to name the test. If yes to saving the test, the option will then be given to name the test. When a test is saved, it will always be saved as the next available number. 1, 2, 3, 4, etc. After naming the test and pressing COMPLETE, display shows: Saving Test # Then gives the test number, then the name the user saved it as. If it is the first saved test and is named Test HIV, the display and printout will show: Saving Test # 1 TEST HIV Read the sample Blank. Then continue with normal sampling following the prompts given by the instrument. See the sections “2.1.14 Blanking” and “2.1.15 Reading Samples” for details. To exit the mode and return to the main prompt, press QUIT. The printer outputs “Test Ended”, and the instrument returns to the main prompt. 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 as follows: First, the unknown sample’s absorbance is calculated and compared to the standard absorbances. The line segment of the standard curve used to determine the concentration of the unknown is the line connecting the pair of standards whose absorbances are closest above and below the unknown absorbance. An unknown sample with absorbance greater than the highest standard absorbance is calculated on the line passing through the highest 2 standard points. An unknown sample with absorbance less than the lowest standard absorbance is calculated on the line passing through the lowest 2 standard points. For samples requiring flowcell aspiration volumes of 350 µl or less, the shorter sample tube (provided in the tubing kit) must be installed. Refer to the section “Flowcell tubing replacement”. Press F2 (PROGRAM) then 4. The display shows two choices. Press 1 and Enter to choose Standard Multi-Point Mode, 2 and Enter for Multi-Point % Absorbance Mode. The Multi-point % Abs mode is similar in calculation to the Multi-Point mode, except that the percent absorbance is calculated and printed, and the standards must be in descending order.

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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. The Select Filter Screen will be shown. Primary Filter is Highlighted. Press the numeric key that corresponds to the desired wavelength. To confirm the choice, press ENTER. The selected wavelength is highlighted. Differential Filter is then Highlighted. Select the differential wavelength in the same way the primary wavelength was chosen and press ENTER. You are then prompted to enter the number of Standards you will be using. Type in the number of standards (1-7) and press ENTER. The instrument prompts you to enter the value of each Standard. 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 ENTER is pressed, the value is shown on the printer. Repeat this step for each standard. The Enter Unit Code screen is shown. Enter the unit’s code (0-13) and press ENTER. See the section “Units of Measurement” for details. The entire list of Units is displayed. Type in the corresponding number and press ENTER. The display then shows the selected unit. Press YES to accept. The Result Parameters screen is then shown prompting the user to set up Ranges and Controls. See section 2.1.9 Ranges and Controls for more on this option. The next two options are first to save the test and then to name the test. If yes to saving the test, the option will then be given to name the test. When a test is saved, it will always be saved as the next available number. 1, 2, 3, 4, etc. After naming the test and pressing COMPLETE, display shows: Saving Test # Then gives the test number, then the name the user saved it as. If it is the first saved test and is named HIV, the display and printout will show: Saving Test # 1 HIV If the instrument is in tube mode, it displays “Referencing Air” and makes an air reference reading. In Flowcell mode, the stored water values are used as a reference. Insert the blank tube or sample the blank material when prompted. See the sections “2.1.14 Blanking” and “2.1.15 Reading Samples” for details. The display shows: The instrument prompts to read each of the standards in turn. Insert the standard tube or sample the standard material. See the section “2.1.15 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, the procedure must be repeated from the beginning. The display shows the Standard curve on the graph and displays: 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 (y) axis, the concentration along the horizontal (x) axis, and the standard numbers along the plotted line.

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The display then prompts the user to read sample. Insert the tube or sample the material. The concentration will be calculated as described above. Repeat this step as desired. The user may re-blank at any time by pressing BLANK. To exit Multi-Point Mode and return to the main prompt, press QUIT or F1. The printer outputs “Test Ended”, and the instrument returns to the main prompt. 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 the user inserts the tube or aspirates 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. The ΔA/min. or rate of the standard will be determined by a linear regression calculation covering the read interval. This ΔA/min. is printed beside S1 and is used to determine the rate factor. ΔA/min.

Concentration of Standard = Factor Choose from three Calculation methods in Rate Mode. Rate by Factor Enter a FACTOR which the instrument uses to calculate the concentration of the sample at each reading. Rate by Standard Supply a STANDARD material which the instrument reads and uses to calculate a factor to obtain the concentration of each sample. Fixed Time Kinetics Enter a FACTOR or supply a STANDARD material as described above, however, results are based on total Δ, not ΔA/min. In addition, Rate by Factor and Rate by Standard tests may be performed individually (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”. Allow a minimum of 15 minutes for the cell temperature to equilibrate. Note: If the instrument is left idle in Rate Mode, the lamp may be OFF. Be sure to turn the lamp on and allow the instrument it’s warm-up time before starting a reaction. 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, the tube gasket supplied MUST first be installed. 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. Rate factors for determining units per litre (U/L) must be derived from the following standard formula: U/L = ΔA/min. x 1000 x TVmL x TF MA x SVmL x LPcm where: U/L ΔA/min TV MA SV LP TF

is units per Litre is the mean change in absorbance per minute is the total volume of the reaction mixture (in ml) 3 is the molar absorptivity (i.e., the MA of NADH at 340nm = 6.22 x 10 ) is the sample volume (in ml) is the cuvette light path (in cm) is the temp factor used to convert assayed activity to the desired temp.

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Refer to the sections “Rate by Standard” and “Fixed Time Kinetics”, below. Rate Mode Press PROGRAM (F2) then press 5 and Enter. The display shows:

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 ΔA/min. 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 cancelled and the instrument returns to the main prompt. Fixed Time Kinetics Fixed Time Kinetics is similar to the other Rate Mode variations. However, instead of basing the final calculation on the ΔA/min. of the sample, the calculation is based on 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. This is also true for Batch Rate Modes. 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, the instrument prompts to enter the number of samples. Note that if running Rate by Standard, The standard must be included as one of the samples. The maximum number of samples = 12. After the blank is read, 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 the 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 to read the samples. Read the samples in the same uniformly-timed manner in which the samples were added. Assign control labelling when the display is prompting to read that sample. (The read time will begin when the initial reading of the first sample is taken.) Note: The choice to set up controls does not function in Batch Mode. To use a control in Batch Mode you must treat it like a sample and count it as one of your samples. After all samples in the batch have had their initial reading, the instrument will count down the remainder of the read time. At the end of the read time, the user will be prompted again to read the samples. Again, read the samples in the same uniformly-timed manner in which the samples were added. After each sample 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 result. Note that interval data and plotting are not available, because the sample does not remain in the cuvette well during 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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Rate By Standard Press 1 to select Rate By Standard. The display shows the Select Filter Screen. Primary Filter is Highlighted. Press the numeric key that corresponds to the desired wavelength. To confirm the choice, press ENTER. The selected wavelength is highlighted. Differential Filter is then Highlighted. Select the differential wavelength in the same way the primary wavelength is chosen and press ENTER. The Wavelengths are then printed. Display shows:

Enter Lag Time (10 Seconds Minimum) and press ENTER (F4). You are then prompted to enter a Read Time. Read Time must be a Multiple of 30. Enter desired time. The instrument prompts the user to enter the value of Standard #1. Enter the value and press Enter. The display shows the select Units Menu. Enter the unit’s code (0-13) and press ENTER. Press YES to accept. See the section “Units of Measurement” for details. The Result Parameters screen is then shown prompting the user to set up Ranges and Controls. See section 2.1.9 Ranges and Controls for more on this option. Save and name the test, as desired. Display shows “Referencing Air”. The Display then asks for the Blank to be read. Its value is printed. The user will then be prompted to read the standard. Insert the tube or sample the material. The display shows:

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The Lag Time will first count down. Then the read time will begin counting down while charting the activity on the Bottom Right of the screen. The F4 (ACCEPT) button can be used at any time after the lag time that the user feels there is sufficient data to report a valid result. After the instrument is finished reading a sample, there will be three buttons at the bottom. F1 (QUIT), F2 (MORE), and F4 (BLANK). Press the F2 (MORE) key. The display shows:

There are 4 Buttons now along the bottom of the display. MODIFY (F1), PLOT (F2), DATA (F3), and RETURN (F4). MODIFY (F1) - This button is used to change the read interval. Press F1. The display shows:

The LEFT (F1) key is used to toggle between the two lines. The far right line indicating the end of read interval and the left line at the beginning of the read interval. Pressing this button once will change its label to RIGHT. The ARROW keys allow the user to move the two lines in order to select a portion of the graph for purposes of calculating ΔA/Min. by Linear Regression. Press OK (F4) to end. The instrument then prints the new ΔA/Min. and Factor. Note: After modifying starting and/or ending times, the print data function still gives the original readings. If you want to record the changes, you must print the modified graph. PLOT (F2) - Press this key to plot and print the graph. 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 the left bar. If ranges were entered, the range interpretation is printed to the right of the concentration. DATA (F3) - Press this key at any time before pressing RETURN (F4) to print the interval data. The absorbance at 0 and each 30 second interval is printed along with the mean absorbance per minute for each interval. If any of the absorbances for the sample are greater than 2.2, a message is printed stating “Absorbance > 2.2” and the display shows the same. If the absorbance per minute for any of the intervals is less than 0.010, the printer outputs “Low Activity” and the display shows “Low Activity” next to “Sample Done”.

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The option to print the data may then be taken by pressing the DATA button. The data can be examined to determine if the sample was not active, if the substrate was exhausted early, or if the reaction started later in the read time. If the latter is the case, the lag time may need to be increased. If the absorbance per minute for any of the intervals was more than 20% from the mean absorbance per minute, the printer shows “Check Linearity” and the display shows the same next to “Sample Done”. Once again, the DATA button may be pressed to examine the data. If neither Low Activity nor Check Linearity are flagged, the interval data may still be printed by pressing the DATA key. MORE (F4) - Press this key to see other options. In the ‘MORE’ menu, the display shows: PURGE (F2) - Press this key to purge Flowcell. RETURN (F4) - Press this key to return to sampling. Re-Blanking may be done at any point by pressing BLANK. To exit Rate Mode and return to the main prompt, press QUIT. The printer outputs “Test Ended”, and the instrument returns to the main prompt. 2.3

Stored Tests

The HumaLyzer 3000 stores up to 120 complete test setups in non-volatile memory, making 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, the user has the option of using the previous curve or reading a new one. There are 44 Pre-Configured tests stored in the instrument, listed below: 1) ALBUMIN 2) BILIRUBIN DCA (Factor 12.5) 3) BILIRUBIN DCA (Factor 58) 4) BILIRUBIN 5) CALCIUM 6) CHOLESTEROL (Standard Mode) 7) CHOLESTEROL (Factor Mode) 8) CREATINE 9) GLUCOSE GOD-PAP 10) GLUCOSE HK (Standard Mode) 11) GLUCOSE HK (Factor Mode) 12) GLUCOSE HK Hemol 13) HEMOGLOBIN 14) IRON (Standard Mode) 15) IRON (Factor Mode) 16) MAGNESIUM 17) PHOSPHORUS 18) POTASSIUM 19) TOTAL PROTEIN (Standard Mode) 20) TOTAL PROTEIN (Factor Mode) 21) TRIGLYCERIDE (Factor Mode) 22) TRIGLYCERIDE (Standard Mode) There are also 6 Utility Tests. They are as follows: 201 Restore ‘Hard Coded’ test parameters (listed above) 211 Enter serial number 213 Calibration Report 215 Enter all calibration settings 248 Enter Filter Labels for positions 7 & 8 249 Reset all filter labels to default

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23) UREA 24) URIC ACID (Standard Mode) 25) URIC ACID (Factor Mode) 26) ACID PHOSPHATASE 27) ALK PHOS 28) AMYLASE CT EPS 29) AMYLASE LIQUID 30) CK - MB 31) CK – NAC 32) GAMMA – GT 33) GOT 34) GPT 35) LDH 36) AA1 (APOA1) 37) AB1 (APOB) 38) LPA 39) RF 40) ASO 41) CRP 42) IGA 43) IGG 44) IGM

2.3.1 Recalling a stored test Press RUN TEST (F1). The display shows a list of all available stored tests. If there is more than one page, use the MORE button to advance the screen to the next page. Use the numeric keys to enter the test number and press ENTER. The user is asked whether or not to print test header. If “NO” is selected, Test name and “Stored Data” is printed. If “YES”, all test parameters are printed. Updated is the date the stored blank and standard values were last updated. If there are no stored blank and standards, then the date is when the test was originally stored or last edited. The blank and curve data is printed and the display shows: Use Stored Blank? Press YES to use the stored blank. The stored value will be used as if it had just been read. If NO, the display prompts to read a new blank. The display then shows: Use stored Curve? Press YES to use the stored factor or standard curve. If NO you will be asked to read new values. If recalling a Multipoint % Abs Mode and choosing to use the stored calibration, the user will be asked to read the first standard only. If a stored curve is not used, the display prompts the user to read the sample. If the test is assigned to a patient in the worklist, the display shows: Run the current worklist? Press YES to use the current stored Worklist. Select NO to continue. The Display shows Referencing Air and then Read the Blank. If there was no stored blank or standard curve, or the user has chosen not to use them, the values that are read now will be automatically saved under the recalled test. When recalling the test the next time, the option to use the stored calibration as described above will be displayed. 2.3.2 Listing stored tests To print the list of all the stored tests, Press TOOLS (F4). Then Press 1 and ENTER. This opens the Stored Data Utilities. Again Select 1 and ENTER. This takes the user to the Stored User Test Menu. Select 1 and ENTER. 2.3.3 Deleting a test If finding that a stored test is no longer needed, it may be deleted. This makes room for another stored test. Use the Procedure from Section 2.3.3 to get to the Stored User Test Menu. Then choose between Deleting all or 1 of the Stored Tests. If selecting 3, Delete a stored test, the instrument prompts the user for a test number. Enter the number of the test that should be deleted and press ENTER. The display then shows “Delete Test ##? Press Yes to confirm the deletion or No to cancel. 2.3.4 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, Use the Procedure from Section 2.3.3 to get to the Stored User Test Menu. Select 4, Edit a Stored Test, and ENTER. Enter the number of the test to be edited. Note: Editing a test will erase any stored blank or standard values for that test, as well as any patient results and stored results (if available). All of the test’s parameters will be recalled and printed. The display shows: (Stored) Mode Edit Filters Y/N Press YES to change the filter wavelengths, or NO to continue. The instrument prompts for the primary and differential filters to be selected. The instrument will ask a series of questions. If choosing YES, enter the new value just as when the test was originally stored. The questions depend on the mode of the test being edited. For example, if editing a factor mode test, the user will be asked to change the factor. If editing a rate test you will be asked if the lag and read times will change. Upon completing the questions, the instrument prints “Edit Complete”.

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2.3.5 Using WORKLIST Press the WORKLIST (F3) Key. The Display shows the Patient ID Menu which consists of: 1 = Add a Patient To Worklist / Use this Feature to Add a Patient. See section “2.1.8 Entering Names”. Once entered, the printer prints New Patient Job List. As tests are entered for the patient, the printer adds them to the list. 15 Tests per Patient is the Maximum allowed. 2 = Run Worklist / Runs the entire stored Worklist or test by test. 3 = Print the Current Worklist / Prints the Current Patient Worklist. Under each Stored Test # and Test Name, the print out shows which patients are assigned to the listed test. This is done for each Stored Test. 4 = Delete a Patient from Worklist / Use the PrintOut of the Patient ID list to find the corresponding Patient ID number that will be deleted. 5 = Delete all of Current Worklist / When this function is chosen, The display asks: Delete the entire Worklist? Press Yes to confirm, No to continue on Patient ID Menu. When using the Worklist, the patient name is shown when prompting for a sample to be read. All results are stored for later recall. When the Worklist is finished the screen clears, the Patients’ reports print and you are prompted: “Delete entire Worklist?” Choose yes or no. Note: If a curve is invalid the following 3 lines are displayed and printed: --CURVE INVALID-Worklist stopped. Please restart the worklist. The test then ends and the Auto-Run Worklist mode is exited. Note: Before adding patients to a Worklist, print the current Worklist (3), delete all (5) or delete patient by patient (4) to delete the patients no longer being used, then enter the needed additional patients (1). This will prevent you from running out of room for patients on your Worklist. 2.4

Special Features

2.4.1 Self-Check The instrument continuously self-checks to insure proper operation. Any error will be immediately reported. The Self-Check feature provides additional tests. To perform the check, press TOOLS (F4), then choose 4 (Diagnostics). Note: The Flowcell and/or tubes must be removed to use this function. In the Diagnostics menu, choose 6 Self Check and press Enter. The display shows:

The EEPROM, NV RAM, Vacuum System, Aspiration Valve, and Photometer are all checked. Test results will be reported on the display and printer. For more information on error messages, see section 2.4.2, Error Messages or section 3, Troubleshooting.

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2.4.2 Flags and Error Messages Flags are displayed to alert the operator when certain limits are approached. After displaying the warning the instrument will continue to function normally. ***** is printed in the concentration field if the absorbance is greater than 2.5 when using tubes, or greater than 3.5 when using the Flowcell. 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 is 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!!— is 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 Multipoint Mode. Since this invalidates the results, the test must be restarted. Error Messages Error messages are displayed when the instrument fails to operate correctly. They are intended to help the operator locate the problem. 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 the user will be allowed to continue. Clear the paper path by gently pulling the obstruction from the printer, and re-starting 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.

Waste is Full!!! (Bottle in top right corner of screen)

Displayed when the waste material has reached the level sensors. 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 the waste bottle is emptied and press ENTER.

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.

Cancelled

This is displayed immediately following a filter wheel error to indicate that the test or mode has been ended.

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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 Flowcell is active and no water values were found in memory. The stored water values have been reset to 0.000. new water values must be read to ensure correct results. Refer to “Flowcell Configuration”.

Do Temperature Calibration Test

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

Do ABS Calibration Test

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

35 Human HumaLyzer 3000 User Manual

36

Contents

3

CLEANING AND MAINTENANCE

38

3.1 Cleaning 3.1.1 Exterior 3.1.2 Flowcell 3.1.3 Waste Bottle

38 38 38 38

3.2 Maintenance 3.2.1 Calibration and Linearity 3.2.2 Opening the Instrument 3.2.3 Lamp Replacement 3.2.4 Flowcell Tubing Replacement 3.2.5 Valve Tubing Replacement

39 39 39 40 41 43

3.3 Storage

43

4

TROUBLESHOOTING

44

5

CONTACT INFORMATION

46

3 CLEANING AND MAINTENANCE 3.1

Cleaning

3.1.1 Exterior CAUTION: Solvents such as acetone or thinner will damage the instrument! Use only water and recommended cleaners! Avoid abrasive cleaners. The 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 Flowcell The Flowcell should be cleaned when the instrument will not be used for an extended period, e.g. overnight, end of shift, and when storing the Flowcell. Proper cleaning will help to prevent clogging of the Flowcell tubing and valve tubing. Cleaning is extremely important to obtaining accurate, repeatable results. If reagent, serum, or other proteinaceous fluid is allowed to dry in the Flowcell, it is extremely difficult to remove and its presence can affect test results. To clean the Flowcell: 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 Flowcell 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 Flowcell for 3 minutes. 5. Purge with at least 15 ml of deionised water. 6. Leave the Flowcell filled with water. 7. If preparing the Flowcell for storage, follow same instructions but purge completely after cleaning. Material required [REF]

18222

FLOW CELL CLEANER Detergent NaOH Sodium azide

100 ml 0.1% < 0.5% 0.1%

HCl

0.1 N

Isopropylalcohol Sodium hypochlorite (bleach)

70% or 1.5%

Chemicals

Disinfectant:

Warning The above chemicals present the following hazards and should be handled with due care: HCl and sodium hypochlorite are corrosive and toxic solutions which cause severe burns. Propane-2-ol (isopropyl alcohol) is highly inflammable and harmful. 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. Always turn instrument “OFF” before disconnecting the waste bottle.

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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 pre-set calibration is very stable. Absolute calibration can be verified with the use of NIST filters, or by periodic comparison to a reference instrument that is known to be calibrated to NIST filters. Calibration may be confirmed using Awareness Technology’s Redi-Check, a commercially available calibration check set which can be obtained from your distributor. A periodic verification of instrument linearity is advised. Since most lab test results are based upon standards rather than upon absolute absorbance, the linearity of the instrument is the more critical indicator of instrument performance. A reduction in linearity with age may be indicative of optical filter deterioration. In this event, filter replacement is required for continued reliable operation. The best way to assure quality instrument performance is to include a sufficient number of controls in each as-say to cover the entire operational range. 3.2.2 Opening the Instrument Refer to Figure 2 - 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. Remove the waste bottle. Move the instrument forward until the front edge overhangs the work surface. Locate and remove the cover screw from the middle of the underside of the front lip. Gently lift the front of the cover upward, taking care to clear the 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 Flowcell Luer fitting.

MAIN PCB

Power Supply

Pump Photometer

Fan Valve

Remove screw from underneath to remove cover Figure 2

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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. Turn Power “Off” and unplug instrument. 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 3, 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. Loosen but do not remove the 2 centre lamp connector screws. Remove the lamp by lifting upward. 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 3, Lamp Alignment. The lamp filament must be centred 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. 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 3, Spot Alignment. The spot should be small and centred on the oval hole in the cell block (behind the lens). If the spot is not centred, 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. 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 F4 (TOOLS). Press 4 and ENTER. Press 1 and ENTER The display shows the voltages for each filter.

Figure 3

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3.2.4 Flowcell Tubing Replacement The Flowcell utilises 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 Flowcell tubing. Remove the Flowcell. Gently lift the Flowcell out of the read well. Remove the cover screws and lift off the upper Flowcell cover. Refer to Figure 4. 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. Find the sample tube. Carefully press fit the end of the sample tube, 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 4 for the proper orientation. Do not reverse the orientation as improper sampling will result. Install the cell body and screws. Feed the exit tube in through the rear of the Flowcell. Press the exit tube over the steel tube. The exit tube and fitting should be installed as shown in Figure 5. Use extreme caution not to damage the fitting.

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Flowcell Handle

Sample Tube Support Exit Tube Sample Tube

(2) #4-40 x 3/8 Pan Head screws w/ Split Lock Washers

Flowcell Handle Base

(4) #4-40 x 1/4 Screws (2) #2-56 x 3/16 Screws Upper Cell Body

Cell Window

Cell Insert Screw

Adjustment Set Screw Figure 4

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Figure 5 3.2.5 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. Set the power switch to OFF (O). Open the instrument as described in “Opening the instrument”. Refer to Figure 6. Locate the valve beside the photometer. Pull back the pinch bracket and remove the valve tubing from the valve body.

Figure 6 Disconnect the valve tubing from the fittings at both ends noting orientation. 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. Lower the cover and replace the screw. 3.3

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 Flowcell as described in “Cleaning”, Store using 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.

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 Remove the Flowcell and allow the Flowcell and waste bottle to dry overnight.  Place the instrument, Flowcell, 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. 4 TROUBLESHOOTING 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 the appropriate wavelengths were selected for the chromophore being read. Tubes should have no bubbles, condensation, scratches or smudges. Poor Linearity If the instrument is several years old, or has been operated in very humid conditions, new optical filters may be needed. 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. Erratic Readings One possible source of erratic readings (excessive dither) is trapped air in the Flowcell. This can be caused by improper installation of the Flowcell tubing. Refer to the section “Flowcell Tubing Replacement”. Check the insertion depth of the Flowcell tubes. Ensure that a leak-free seal is made. Lamp failure The lamp is rated to read over 300,000 tubes, and the lamp saver feature minimises 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”. 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 Flowcell. Press PURGE and listen for aspiration. If air is heard entering the fitting, the valve tubing is clear, but the Flowcell is blocked. Refer to the sections “Cleaning” and “Replacing Flowcell tubing”. If the valve clicks but the pump does not run when pressing 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. Restore Calibration Data 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 Temperature Calibration Test Do ABS Calibration Test 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 the instrument is turned on, a mode is selected, or a test is recalled. 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 cell are set to 0.0. Do not enter values other than those recorded on the calibration label unless absolutely necessary.

44

Follow these steps to restore the electronic calibration: 1. Shut off the instrument. Remove any tubes or cuvettes from the read well. Carefully lift up the instrument and locate the Calibration Data label on the underside of the unit. There are (2) values recorded there: Absorbance 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 TOOLS (F4). Press 4 and Enter. The Diagnostics Menu is shown. Choose 3 for Absorbance Calibration and Enter. Enter the Number. 5. Choose 4 for Temp Calibration and Enter. Enter the Number. 6. Press Run Test (F1), type in 213, and press ENTER to get a report of the calibration data. The 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. 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! Filter labels need to be re-entered 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 RUN TEST (F1), type in 248, and press ENTER. The display prompts: Key 7 = ??? nm Type in the wavelength for Key 7 that is printed on the label and press ENTER. Repeat for Key 8. use “000” for unused filter positions. Press QUIT to return to the main prompt. Note that, if values for Key 7 and Key 8 are entered when there are no filters present, the filters will be flagged as “low” when Self Check is run. For Key 8. use “000” for unused filter positions. Press QUIT to return to the main prompt. Note that, if values for Key 7 and Key 8 are entered when there are no filters present, the filters will be flagged as “low” when Self Check is run. Other Tests: Vacuum count The last 4 readings are averaged together and compared to 200 Greater than 203 shuts the vacuum off Less than 197 turns it on. Cell and block temp use the same cut-off numbers. The last 4 readings are averaged together and compared to 462 Greater than 466 turns the heat off. Less than 458 turns the heat on. The Block heat temperature is not displayed if the count is less than 250 Waste count A count of less than 150 is considered a full bottle condition. The "Filter Wheel Speed" menu selection provides the user with the current wheel speed. The speed is set to 300 +/- 10

45 Human HumaLyzer 3000 User Manual

5 CONTACT INFORMATION In the unlikely event that a problem is experienced with the instrument, please consult your dealer first. Dealer:

If the dealer is unable to resolve the problem, our support staff at Human GmbH is happy to assist, and can be reached in Germany by: Fax: (49) 6122 – 9988 - 100 E-mail: [email protected] Mail: Human GmbH Max-Planck-Ring 21 D-65205 Wiesbaden Germany When contacting Human GmbH, please provide the following:  The serial number of the instrument  A description of the problem with as much detail as possible  Printouts, which can be submitted by mail, fax or e-mail

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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