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User Manual

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Cat.-No.: 16700/1
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1. INTRODUCTION 1
1.1 Applications 3
1.1.1 Intended Use 3
1.1.2 Summary of the Instrument 3
1.2 Specifications 3
1.3 Warning Markings 5
1.3.1 Safety Symbols 5
1.3.2 Safety Terms 6
1.4 Safety Precautions 6
1.5 Setup 7
1.5.1 Unpacking 7
1.5.2 Installation/Preparation 8
1.5.3 Keypad Description 10
1.6 Checkout 11
1.7 Getting Started 12
1.7.1 Set Date/Time and Laboratory Name 12
2. OPERATING PROCEDURES 14
2.1 General Selections 14
2.1.1 Flowcell Configuration 14
2.1.2 Lamp Warm-up and Lamp Saver 15
2.1.3 External Ports 15
2.1.4 Serial Port 16
2.1.5 PC Connection 16
2.1.6 Error Messages While Using the Parallel or Serial Ports 16
2.1.7 Units of Measurement 16
2.1.8 Entering Names 17
2.1.9 Ranges and Controls 18
2.1.10 Reports 20
2.1.11 Blanking 22
2.1.12 Reading Samples 22
2.1.13 Bichromatic Operation (Differential Filter) 23
2.2 Calculation Programs 24
2.2.1 Absorbance Mode 24
2.2.2 Single Standard Mode 25
2.2.3 Factor Mode 26
2.2.4 Multi-point Mode 27
2.2.5 Rate Mode 29
2.3 Stored Tests 34
2.3.1 Recalling a stored test 35
2.3.2 Listing stored tests 35
2.3.3 Deleting a test 35
2.3.4 Editing a test 36
2.3.5 Using WORKLIST 36
2.4 Special Features 37
2.4.1 Self-Check 37
2.4.2 Flags and Error Messages 37
3. CLEANING AND MAINTENANCE 39
3.1 Cleaning 39
3.1.1 Exterior 39
3.1.2 Flowcell 39
3.1.3 Waste bottle 39
3.2 Maintenance 40
3.2.1 Calibration and Linearity 40
3.2.2 Opening the Instrument 41
3.2.3 Lamp Replacement 42
3.2.4 Flowcell Tubing Replacement 44
3.2.5 Valve Tubing Replacement 45
3.3 Storage 45
4. TROUBLESHOOTING 46
5. CONTACT INFORMATION 50
0234*4356*7689*:7;<=

2/48 User Manual HUMALYZER 3000


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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.

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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 calibra-
tion, 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:

$:4DH:;<C6*#D56
The HUMALYZER 3000 reads monochromatic or bichromatic differential absorbances at user-selected wave-
lengths.

19;<5;H5*#D56
Reports concentrations based on a single standard concentration.

);96*#D56
Reports concentrations either based on the average !"absorbance per minute multiplied by a user supplied fac-
tor (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.

J;C9DH*#D56
Reports concentrations by multiplying absorbances by a specified factor.

#F793KBD3<9*#D56
Reports concentrations or percent absorbances based on the point-to-point connection of up to seven user-en-
tered 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.

>?E*1B6C383C;93D<4
Specification Date .............................................22 May 2003
Model Name .....................................................Humalyzer 3000
Spectrophotometer Type...................................Filter photometer
Optical Configuration.........................................Single beam with continuously rotating filter wheel
......................................................Monochromatic or bichromatic reading

User Manual HUMALYZER 3000 3/48


......................................................8 filter positions
Usable Spectral Range .....................................330 to 670 nm
System Procedures...........................................Open and by stored menu
Calculating Modes.............................................Absorbance
......................................................Single Standard
...................................................... Differential samples
......................................................Factor Mode
...................................................... Differential samples
......................................................Multi Standard Mode (up to 7 standards)
......................................................Multi Standard % Abs (up to 7 standards)
......................................................Kinetic Mode (consecutively, or simultaneously (Batch))
...................................................... By Factor or by Standard
......................................................Fixed Time Kinetic
...................................................... By Factor or by Standard
Channels...........................................................44 Pre-Configured, 76 Open
Source of Radiation...........................................Tungsten Halogen, 10 Watt, with automatic lamp saver
Selection of Wavelength....................................By filter
Filter Type.........................................................4-cavity interference, long-life ion beam-assisted deposition
Wavelength Accuracy .......................................+/- 3 nm
Filter Location ...................................................After sample (heat absorbing filter before sample)
Filter Selection ..................................................Automatic by software or via keyboard
Wavelengths .....................................................340, 405, 505, 545, 580, 630 nm supplied standard
.........................................................................other/additional filters optional
Half Bandwidth..................................................< 10 nm
1/100 Bandwidth ...............................................14 nm at 340 nm
False Radiant Energy Ratio...............................< 0.001 at 340 and 405 nm
Cuvette ..............................................................1 cm square, 12 cm round, flow through
Supplied Type...................................................Flow-through
Material.............................................................316 stainless, borosilicate windows
Geometry..........................................................Cylindrical, 2.3 mm dia x 5 mm +/- 0.05 mm
Illuminated Volume............................................21 µl
Minimum Read Volume .....................................250 µl
Aspiration/Purge ...............................................Vacuum pump at 18 cm of Hg
Valve ................................................................Silicone pinch type
Cuvette Holder..................................................Thermostatically controlled compartment at 37° C
Detector ............................................................Gallium-Arsenide-Phosphide photodiode
Signal Processing and Display
Display Type .....................................................240x128 Graphic LCD w/ Backlight
Scale of Display
Absorbance.......................................................-0.5 to 3.5 (flow-through mode)
.........................................................................-0.5 to 2.5 (tube or 1 cm cuvette)
Concentration ...................................................Maximum 999,999
Kinetic Results ..................................................Abs/min with resolution of 0.0002 A/min
Zero Compensation...........................................Automatic
Range ...............................................................-0.5 to 2.5 absorbance
Signal Outputs
Parallel ............................................................Centronics/IBM-PC compatible
Serial ................................................................RS-232 at 9600 baud, 8 data, 1 stop,
.........................................................................no parity Bi-Directional
Data Input.................................... ......................1) 20 Key Keypad, 2) PS2 101 Keyboard (connector available at
back of instrument)
Spectrophotometric Inaccuracy
Flow-through.....................................................< 0.5 % at 1 absorbance, 340/630 nm NADH solution
......................................................< 1% at 2 absorbance, 340/630 nm NADH solution
......................................................< 3 % at 3 absorbance , 340/630 nm NADH solution
......................................................< 0.5 % at 1 absorbance, 405/630 nm PNP solution

4/48 User Manual HUMALYZER 3000


......................................................< 1 % at 2 absorbance, 405/630 nm PNP solution
......................................................< 3 % at 3 absorbance, 405/630 nm PNP solution
Stability.............................................................Better than 0.003 A/hr monochromatic after warm-up
......................................................Better than 0.001 A/hr bichromatic after warm-up
Warmup Time ...................................................90 seconds photometric
......................................................15 minutes for temperature compartment
Electronics ........................................................Z180 Microprocessor 18 MHz
......................................................128k eeprom
......................................................32 K bytes Nonvolatile RAM (NVRAM)
Power ...............................................................Auto-Switching Power Supply
......................................................Voltage source: 100 - 240 VAC Frequency: 50/60 Hz
......................................................Power consumption: 90 watts
......................................................Installation Category: CAT II
......................................................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
Dimensions and Weight ...................................43cm(L) x 39cm(W) x 15cm(H) Lid closed, (32cm Lid opened),
7.5 kg
Space Requirements.........................................10 cm clearance on all sides

Environmental Conditions for


Safe Operation:.................................................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.
Recommended Operating Temperature ............15-35°C
Recommended Operating Humidity...................Between 10 and 85%, non-condensing

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1;869I*4IG:D74*N23C2*G;I*;BB6;H*D<*926*BHD5FC9O

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)34=*D8*12DC= *T(;H92U*06HG3<;7 )686H*0D*#;<F;7**** )34=*D8*3<86C93D<

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.

User Manual HUMALYZER 3000 5/48


>?+?E*1;869I*06HG4
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 poten-
tially infectious materials must use universal precautions to reduce the risk of exposure to these agents.

>?V*1;869I*QH6C;F93D<4
To assure operator safety and prolong the life of the instrument, carefully follow all instructions outlined below.

)6;5*@<49HFC93D<4
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 fa-
miliar with the instrument and its capabilities before attempting any clinical diagnostic tests. Refer any questions
to your instrument service provider.

16HR3C3<M
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.

Q6H4D<;7*QHD96C93R6*(WF3BG6<9
Many diagnostic assays utilise materials which are potentially biohazardous. Always wear protective apparel and
eye protection while using this instrument.

JD77DN*.B6H;93<M*@<49HFC93D<4
Do not use the instrument in a manner not specified by the manual or the protection provided by the instrument
may be impaired.
"46*QHDB6H*QDN6H*-DH5
Use only the power cord specified for this product and certified for the country of use.

PHDF<5*926*QHD5FC9
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.

.:46HR6*$77*06HG3<;7*);93<M4
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.

@<49;77*;4*A3H6C965
The Humalyzer 3000 should be installed on a stationary flat working surface capable of supporting the instru-
ment’s weight (10 kg) safely for safety and ventilation purposes. The mounting surface should be at least 61 cm
deep and free of vibrations.

QHDR356*QHDB6H*X6<937;93D<

6/48 User Manual HUMALYZER 3000


Refer to the installation instructions for details on installing the product so it has proper ventilation. The instru-
ment should be surrounded by the following clearances: 10 cm around perimeter of unit and 10 cm on top.
AD*/D9*.B6H;96*L392DF9*-DR6H4
Do not operate this instrument with covers and panels removed.

"46*QHDB6H*JF46. 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.

$RD35*(YBD465*-3HCF39HI
Do not touch exposed connections and components when power is present.

$RD35*(YC6443R6*AF49
Do not operate in an area with excessive dust.

AD*/D9*.B6H;96*L392*1F4B6C965*J;37FH64
If damage is suspected to this instrument, have it inspected by a qualified service person.

AD*/D9*.B6H;96*3<*L69ZA;GB*-D<5393D<4?

AD*/D9*.B6H;96*@<*$<*(YB7D43R6*$9GD4B26H6?

[66B*@<49HFG6<9*1FH8;C64*-76;<*;<5*AHI
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% iso-
propyl alcohol may be used as a disinfectant. Take special care not to spill liquid inside the instrument.

.B6H;93<M*QH6C;F93D<4
Be sure to run a sufficient number of controls in each assay. If controls are not within their acceptable limits,
disregard test results.
S3D2;\;H5*QH6C;F93D<4

BIOHAZARD

L$)/@/P*K*@8*926*L;496*:D9976*34*DR6H9FH<65*5FH3<M*DB6H;93D<]*3GG653;967I*469*926*BDN6H*4N39C2*9D*.JJ
T,U?*@8*9234*DCCFH4]*926*3<49HFG6<9*G;I*534C2;HM6*;*4G;77*;GDF<9*D8*N;496*G;96H3;7*8HDG*926*N;496*:D9976
R3;*926*83993<M*D<*926*:D99DG*D8*926*3<49HFG6<9?*0234*G;96H3;7*42DF75*:6*9H6;965*;4*BD96<93;77I*:3D2;\;H5K
DF4?*$BBHDBH3;96*C76;<*FB*D8*926*G;96H3;7*42DF75*:6*D:46HR65?

>?^*169FB

>?^?>*"<B;C=3<M
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 Description

Heat Block ..................................................................... External Incubation Block


Waste bottle................................................................... Plastic bottle
Cleaning solution ........................................................... Plastic bottle containing Flowcell cleaning solution
Bottle cap assembly ....................................................... Bottle cap, tubes, sensor wires

User Manual HUMALYZER 3000 7/48


Paper rolls...................................................................... (2) Thermal printer paper
Power cable..................................................................... Heavy cord
Serial cable ................................................ .................... RS232
Flowcell.......................................................................... ”T”-shaped object with square extension, in plastic box
Tool Kit and Spare tubing
Valve tubing..................................................................... Silicone tube
Sample tube, long...................................... ..................... Teflon tube, swaged end, for sample
Exit tube..................................................... ..................... Teflon tube with male Luer attached
Tube gasket..................................................................... Foam rectangle with round hole
Tubing gripper........................................... ...................... Rectangle of emery paper
Hex wrench.................................................................... 1.6 mm
Operator’s Manual.......................................................... This document
Contact your distributor if anything is missing.

>?^?E*@<49;77;93D<ZQH6B;H;93D<
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 5 A & B (located immediately before the section “Valve tub-
ing 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 color-coded; match the
male Luer cap to the color-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.

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 require-
ments.

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

8/48 User Manual HUMALYZER 3000


these fasteners or connections. An alternate method of grounding is provided by connecting the grounding ter-
minal 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 op-
eration, 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

L$)/@/PO*JDH*CD<93<F65*BHD96C93D<*;M;3<49*H34=*D8*83H6]*;7N;I4*F46*926*4B6C38365*8F46* 8DH* H6B7;C6G6<9?


A34CD<<6C9*BDN6H*CDH5*8HDG*G;3<4*4FBB7I*:68DH6*H6B7;C3<M*8F464?

@<46H93<M*926*J7DNC677*_*!"#$%&'()&)*+,)-)&./0+123&/(&42,.135&+6)&7829.)88&+2&()/+&1-:,2:),8;&-/;&</-=
/5)&1+&2,&+6)&13(+,0-)3+>*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 left rear of the instrument to ON (1). The display shows:

-677*06GB*Z*!6;9*S7DC=*06GB (Y9?*[6I:D;H5 ***%;GB*****J7DNC677 X;CFFG*QH644FH6

!6;93<M

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T"46H
1B6C38365U

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 QH3<96H*169K"B*>?`?E 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 Q$Q() key repeatedly until the paper “catches” and begins to feed into the printer. When the
printer paper exits at the top of the printer, stop pressing the Q$Q()*key. The paper may be pulled through to
help with alignment. Place the paper roll into the printer well.

User Manual HUMALYZER 3000 9/48


"43<M*926*J7DNC677*_*To aspirate using the Flowcell, activate the 1;GB76*16<4DH. 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.

-76;<*926*J7DNC677 - Press the 0..%1*TJVU key. Select E 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 1;GB76* 16<4DH 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*1;GB76*16<4DH 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.

QFHM6 – Activate the 1;GB76*16<4DH 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”.

>?^?+*[6IB;5*A64CH3B93D<
Refer to Figure 1, Keypad Layout. The Function keys (J> through JV) correspond to the four keys shown at the
bottom of the screen in the same order. For example, in the opening screen, J> = Run Test, JE*= Program, J+ =
Worklist, JV = Tools.

When applicable, the (<96H* key on the main keypad performs the same function as the (<96H* Function key
shown on the screen.

%;GB = Toggles the lamp on or off.

%3<6*J665 = Internal Printer, feeds one line at a time; External Printer, skips one line.

JDHG*J665*= External Printer, initiates the printer to print all data stored in its internal memory.

J3MFH6*>?*Keypad Layout

10/48 User Manual HUMALYZER 3000


>?a*-26C=DF9
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 cu-
vettes, 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).

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”.)
!"#$%&'()*+,,,* ***-.*/
00122133**!!422

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 pro-
duces results other than those described here, refer to the section entitled “Troubleshooting”, or contact your
dealer for assistance.

User Manual HUMALYZER 3000 11/48


>?`*P6993<M*19;H965

>?`?>*169*A;96Z03G6*;<5*%;:DH;9DHI*/;G6
Press the JV Key (Tools). The display shows the following options:

>*b*19DH65*A;9;*"93739364. This is where the User Test Data Menu, the Control Data Menu, and the Patient Re-
sult Data Menu are located.

E*b*J7DNC677*-D<83MFH;93D<. Turn Flowcell “Off” to use Tubes or cuvettes, “On” if using Flowcell.

+*b*QH3<96H*169FB. This allows the user to set up either the internal or external printer.

V* b* A3;M<D493C4* #6<F. This is where the Filter Voltages, Filter Wheel Speed, Absorbance Calibration, Tem-
perature Calibration, and Current Vac, Temp, Waste Count are found. Also a Self Check, shown below (see Sec.
2.4.1):

^*b*P6<6H;7*-D<83MFH;93D<. This is where the operator will set User Specific Options.

Press ^. The next screen offers four options. “Set Date and Time”, “Enter Laboratory Name”, “Delete Laboratory
Name”, “Cell Heat Control”, or “Block Heat Control”.

>* b* 169* A;96* ;<5* 03G6. This screen will ask to choose a Date Format. Choose , for MM/DD/YY or > for
DD.MM.YY (Eurodate format), and press*(<96H.

!"#$%&'(&)*+,-&.&/0+,$*$&+,*#1)2$,#3&#0$&4.#$&+*&(+5$4&66788799

Enter the Date as month, day, and year (or day, month, year in Eurodate format) using two digits each and sepa-
rating the entries with the decimal point, then press (<96H. Enter the time as hour, minute, and seconds using
two digits each and separating the entries with the decimal point, then press (<96H. Use “13” for 1 PM, “14” for
2PM, etc.

E*b*(<96H*%;:DH;9DHI*/;G6. To enter the Laboratory Name, see section “E?>?c*(<96H3<M*/;G64” in this man-
ual.

+* b* A67696* %;:DH;9DHI* /;G6?* Press + and the Laboratory Name is deleted and the user is returned to the
0..%1 menu.

V*b*-677*!6;9*-D<9HD7.*Press*, and Enter to turn the Heat Cell “Off”, > 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 tem-
perature of the cell is automatically controlled to 37°C by the software.

^*b*S7DC=*!6;9*-D<9HD7?

Press*, and Enter to turn the Heat Cell “Off”, > 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 flow-
cell to equilibrate after insertion.

/D96O* (R6<* N392* 96GB6H;9FH6* CD<9HD7* 534;:765]* 926* ;G:36<9* 96GB6H;9FH6* D8* 926* C677* 34* 4DG6N2;9* 23M26H
92;<*HDDG*96GB6H;9FH6?

12/48 User Manual HUMALYZER 3000


>?`?E*QH3<96H*169*"B
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 commu-
nicate 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*JV*T0DD74U. At the “Instrument Tools” screen, select +* “Printer
Setup”. Choose the Printer type. To select the Humalyzer 3000’s Internal Printer, select >. If using an External
Printer or serial port, select E. The third selection is +*K*@<96H<;7*QH3<96H*JD<9*1;GB76?*This prints a list of char-
acters in both draft and letter in the five available contrast settings on the internal printer.

>*K*@<96H<;7 – The display shows:

@<96H<;7* QH3<96H* 19;9F4* TJ>U - The current status is highlighted. Press J>* T10$0"1U to toggle to the desired
status.

@<96H<;7*QH3<96H*-D<9H;49*TJEU - The current contrast setting is highlighted. To move to the desired setting, press
JE*T-./0)$10U. Keep in mind that the lighter settings print faster.

@<96H<;7*QH3<9*dF;739I*TJ+U - The current quality setting is highlighted. Letter is a higher quality print, but much
slower on print time. Press J+* Td"$%@0&U to toggle between the two selections. Once these selections are
made, press -.#Q%(0(*TJVU to return to the instrument tools page.

(Y96H<;7 - The display shows:

(Y96H<;7*QH3<96H*19;9F4 - Shows current status. Use J>*T10$0"1U to toggle to chosen Status.

-FHH6<9*#;Y3GFG*%3<64*Q6H*Q;M6 - Shows current number. To change this number, Press JE*T%@/(1ZQPU and
enter the number. Press Complete to return to the instrument tools menu.

User Manual HUMALYZER 3000 13/48


E?*.Q()$0@/P*Q).-(A")(1
E?>*P6<6H;7*1676C93D<4

E?>?>*J7DNC677*-D<83MFH;93D<
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 JV
(0..%1). Then press E, “Flowcell Configuration”, (<96H. The display shows:

Press J> T10$0"1U to change Flowcell status, in this case to “On”. The Flowcell immediately turns on and “ON”
is highlighted. To change the volume sampled, select JE TX.%"#(U. The display shows:

Choose the number which corresponds with the desired volume. For instance, type , for the volume 750, then
(<96H. The display shows the Flowcell configuration menu. The Current Sample Volume reflects the chosen
volume.

14/48 User Manual HUMALYZER 3000


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

!"#$%&#6)()&2:+123(&-/;&238;&?)&0()<&14&+6)&7829.)88&1(&/.+1@)>

>b)6;5* L;96H* )686H6<C6. 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.

EbJ7DNC677*$73M<G6<9. Choosing E and (<96H shows the Flowcell Alignment Screen. First, the Flowcell should
be active but NOT inserted into the read well. Press F3 (Q)@/0) 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 de-
creases, turn the setscrew in the opposite direction.

Repeat until the value is >50%. When complete, press (/0() to return to the previous prompt. New water val-
ues must be read as described above in )6;5*L;96H*)686H6<C6?

E?>?E*%;GB*L;HGKFB*;<5*%;GB*1;R6H
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 %$#Q*to turn the lamp on.

E?>?+*(Y96H<;7*QDH94
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 Multi-
Directional (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).

User Manual HUMALYZER 3000 15/48


E?>?V*16H3;7*QDH9
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.

E?>?^*Q-*-D<<6C93D<
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.

E?>?a*(HHDH*#644;M64*L2376*"43<M*926*Q;H;7767*DH*16H3;7*QDH94
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 “5()6$%
)(7(6-()*89:*)($;&” 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.

E?>?`*"<394*D8*#6;4FH6G6<9
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:

16/48 User Manual HUMALYZER 3000


Press e#.)(f*TJEU to see the rest of the choices:

Press the numeric key that corresponds to the choice and (/0(). The units for that code are displayed. To
confirm the choice press &(1. To select a different unit, press /. and a different numeric key.

E?>?c*(<96H3<M*/;G64
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 dis-
play is shown if no external keyboard is connected:

The cursor is the small triangle beneath the “A” on the top line. Press V*to move the cursor to the left, a*to move
the cursor to the right, E for up, or c for down. When the cursor is beneath the first letter of the chosen name,
press 1(%(-0. The bottom line clears and shows the selected letter. Continue using the E, c, V*and a*keys and
1(%(-0*to select each letter in the name. When complete, press -.#Q%(0(. To remove a letter from the end
of the name, press JE*TS;C=*1B?U. To cancel and return to the main prompt, press d"@0.

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. (ie. Ctrl, Alt, Tab, Esc, etc.)

User Manual HUMALYZER 3000 17/48


E?>?g*);<M64*;<5*-D<9HD74
In all modes except Absorbance Mode, the user has the option of entering ranges and / or controls. The display
will show:

Press “>” (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 (/0()U. Enter the concentration limits for the Normal Range and Linear
Range.

The display will show:

18/48 User Manual HUMALYZER 3000


The user may also change any of the values by using the -%($)TJ+U key or the $)).L*TJE) 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.

,",$ 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 (/0() when -.#Q%(0( is highlighted.

The user is returned to the Results Parameters Setup Menu. Press* E to Setup controls. The instrument allows
the user to enter and name up to 3 controls per test. Controls are designated samples with specified concentra-
tion ranges that provide a reference for comparisons. The display shows:

Select >, E or + and (<96H to choose the desired control type. A Normal control is used in this example. Select >.
The display shows:

From this menu, if J>* Td"@0U is chosen, the instrument returns to the Main Menu and quits the test. Press JV
TA34;:76U and return to the Result Parameters Setup Menu. If J+*T(/$S%(U*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 e,g?,`f. When finished, press JV*T(/0()U. The display will prompt you to enter a Low Range
Limit.

User Manual HUMALYZER 3000 19/48


Enter the Low Range and press (<96H. Then input the High Range and press (<96H?*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 (<96H. The
display will return to the Control Selection menu. Select another control or press V to return to the Result Pa-
rameters Setup Menu.

Control results can be saved and used later to generate a Levey-Jennings report. (See section E?>?>, Reports
for more info.)

When finished, select +, Setup Complete.

E?>?>,*)6BDH94
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 labo-
ratory information. Patient data is stored and retrieved by patient name, and there is room for a total of 512
rsults.

To print a report:

At the end of shift or reporting period, press d"@0* so that the instrument displays the main prompt. Press JV
T0..%1U. Press >. The display shows:

>*b*19DH65*"46H*0649*#6<F. Press > and the display shows:

20/48 User Manual HUMALYZER 3000


Press > to Print a menu of all of your stored tests.

Press E to Delete all of your stored tests.

Press + to Delete one of your stored tests.

Press V to Edit one of your stored tests.

Press ^ to Download your tests from a connected PC. (See section E?V?> for info)

Press a to return to 19DH65*A;9;*"93739364*#6<F.

E*b*19DH65*-D<9HD74*#6<F. Press E and the display shows:

Press > – Enable/ Disable controls in your stored tests by selecting the test number.

Press E – Deletes all stored control results.

Press + – Deletes stored control results by test and lot #.

Press V – Prints controls stored in a test by a chosen test #. It prints Test #, Control Data, Lot Number, Type
Name, and Result.

Press ^ – Creates a Levey-Jennings Report using a selected test and control results.

Press a to return to*19DH65*A;9;*"93739364*#6<F?

+*b*19DH65*Q;936<9*)64F79*#6<F. Press + and the display shows:

User Manual HUMALYZER 3000 21/48


Press > – Print a patient report by a Patient ID you select.

Press E – Delete all of a patients results by ID.

Press + – Delete all results for a selected test #.

Press V – Delete ALL stored patient results.

Press ^ to return to 19DH65*A;9;*"93739364*#6<F.

Press J>*Td"@0U to return to the main menu.

E?>?>>*S7;<=3<M
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” be-
low.) 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
S%$/[.

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
“S%$/[” key, blanking can be done anytime and as many times as the user chooses.

E?>?>E*)6;53<M*1;GB764
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.

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 instru-
ment 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.

22/48 User Manual HUMALYZER 3000


E?>?>+*S3C2HDG;93C*.B6H;93D<*TA3886H6<93;7*J3796HU
The instrument allows the user to read bichromatically with no increase in read time. Use the instrument bichro-
matically whenever possible, especially in Rate Mode. The absorbance at the differential wavelength is sub-
tracted 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
non-uniform wall thicknesses when using disposable plastic cuvettes or glass tubes. In order to preserve sensi-
tivity, it is important to choose a differential wavelength for which the chromophore being assayed exhibits mini-
mal absorbance.

Wavelength Chromophore

340 UV

405 purple

505 blue green

545 emerald green

580 yellow

630 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 ab-
sorbance readings are within 10% of each other, then bichromatic differential reading is beneficial. If the differ-
ence 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 orienta-
tion 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 as-
say, 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.

User Manual HUMALYZER 3000 23/48


E?E*-;7CF7;93D<*QHDMH;G4

E?E?>*$:4DH:;<C6*#D56
In Absorbance Mode, the instrument reads and prints sample absorbances at selected wavelengths. The instru-
ment prints the date and time and the mode of operation.

Press Q).P)$#*TJEU. Select > and (/0().

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 (/0(). The
selected wavelength is highlighted.

DIFFERENTIAL FILTER is then Highlighted.

Select the differential wavelength or press 0 to read monochromatically and press (/0(). 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:
<$-68=*>(5:*?

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:
**<$-68=*>(5:*?***@*!AB

If in tube mode, the instrument now makes an air reference reading. If Flowcell is active, it uses the stored read-
ing.

The display then shows:

Insert the blank tube or sample the blank material. See the section eE?>?>>*S7;<=3<Mf for details. When finished
reading, remove the tube or sample the material. Re-blanking may be done at any point by pressing S%$/[.

24/48 User Manual HUMALYZER 3000


The display shows:

Remove the sample and repeat as necessary. To exit Absorbance Mode and return to the main prompt, press
d"@0 TJ>U. The instrument prints “Test Ended” and returns to the main prompt.

E?E?E*13<M76*19;<5;H5*#D56
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*Q).P)$#*TJEU. Select*E. The Display Shows:

<:$8;$);*29;(

06CC()(8:6$%*<$#D%(5E

Press &(1 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 /. 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 (/0(). 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 (/0(). The Wavelengths are then printed.

The display shows:

Enter the value of the standard and press (/0(). To clear a mistake and re-enter the factor press -%($). The
standard concentration is then printed. Note: The instrument will accept a factor which is up to seven digits, and

User Manual HUMALYZER 3000 25/48


there can be up to (2) decimal places.

The instrument then prompts for a unit of measure to be entered. Enter the units code (0-13) and press (/0().
See the section “2.1.7 Units of Measurement” for details. The entire list of Units is displayed. Type in the corre-
sponding number and press (/0(). The display then shows the selected unit. Press &(1 to accept.

The Result Parameters screen is then shown prompting the user to set up Ranges and Controls. See section
E?>?g*);<M64*;<5*-D<9HD74 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:
<$-68=*>(5:*?

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:
<$-68=*>(5:*?***@*!AB

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 S%$/[. To exit Standard Mode and return to the main
prompt, press d"@0. The printer outputs “Test Ended”, and the instrument returns to the main prompt.

E?E?+*J;C9DH*#D56
In Factor Mode, the instrument reads absorbances at the selected wavelengths, and calculates concentrations
by multiplying the absorbance by the user supplied factor.

Press Q).P)$#*TJEU. Select +. The Display Shows:

F$7:9)*29;(
06CC()(8:6$%*<$#D%(5E

Press &(1 to use differential samples. This works exactly as described below, except that each sample has its

26/48 User Manual HUMALYZER 3000


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 /. to continue.

The Select Filter Screen will be shown. Primary Filter is hilighted. Press the numeric key that corresponds to the
desired wavelength. To confirm the choice, press (/0(). 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 (/0(). The Wavelengths are then printed.

Enter the Factor when prompted and press (/0(). To clear a mistake and re-enter the factor press -%($).
When (/0()*is pressed, the factor is shown on the printer.

!2+)%&#6)&13(+,0-)3+&9188&32+&/..):+&/&4/.+2,&961.6&1(&-2,)&+6/3&()@)3&<151+(A&/3<&+6),)&./3&?)&0:&+2&BCD
<).1-/8&:8/.)(>

Enter the units code (0-13) and press (/0(). See the section “Units of Measurement” for details. The entire list
of Units is displayed. Type in the corresponding number and press (/0(). The display then shows the selected
unit. Press &(1 to accept.

The Result Parameters screen is then shown prompting the user to set up Ranges and Controls. See section
E?>?g*);<M64*;<5*-D<9HD74 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:
<$-68=*>(5:*?

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:
<$-68=*>(5:*?***@*>G<>*!AB

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 d"@0. The printer outputs “Test Ended”, and the instru-
ment returns to the main prompt.

E?E?V*#F793KBD3<9*#D56
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 un-
known is the line connecting the pair of standards whose absorbances are closest above and below the un-
known 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 stan-
dard absorbance is calculated on the line passing through the lowest 2 standard points.

JDH*4;GB764*H6WF3H3<M*87DNC677*;4B3H;93D<*RD7FG64*D8*+^,*h7*DH*7644]*926*42DH96H*4;GB76*9F:6*TBHDR3565*3<
926*9F:3<M*=39U*GF49*:6*3<49;7765?*)686H*9D*926*46C93D<*eJ7DNC677*9F:3<M*H6B7;C6G6<9f?

Press JE* TQ).P)$#U then V. The display shows two choices. Press > and (<96H to choose Standard Multi-
Point Mode, E and (<96H for Multi-Point % Absorbance Mode. The Multi-point % Abs mode is similar in calcula-
tion to the Multi-Point mode, except that the percent absorbance is calculated and printed, and the standards
must be in descending order.

User Manual HUMALYZER 3000 27/48


/.0(

@<*#F793KBD3<9*GD56]*926*49;<5;H54*42DF75*:6*3<*DH56H*8HDG*73M29649*9D*5;H=649?

@<*#F793KBD3<9*i*$:4*GD56]*49;<5;H54*GF49*:6*3<*DH56H*8HDG*5;H=649*9D*73M29649?

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 (/0(). 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 (/0(). You are then prompted to enter the number of Standards you will be using. Type
in the number of standards (1-7) and press (/0().

The instrument prompts you to enter the value of each Standard. Type in the value, in units, of the standard and
press (/0(). To clear a mistake and re-enter the standard press -%($) once. When (/0() is pressed, the
value is shown on the printer. Repeat this step for each standard.

The Enter Unit Code screen is shown. Enter the units code (0-13) and press (/0(). See the section “Units of
Measurement” for details. The entire list of Units is displayed. Type in the corresponding number and press
(/0(). The display then shows the selected unit. Press*&(1 to accept.

The Result Parameters screen is then shown prompting the user to set up Ranges and Controls. See section
E?>?g*);<M64*;<5*-D<9HD74 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 -.#Q%(0(, Display shows:
<$-68=*>(5:*?

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:
<$-68=*>(5:*?***@*!AB

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 “E?>?>V* S7;<=3<M” and
“E?>?>^*)6;53<M*1;GB764” 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 “E?>?>^*)6;53<M*1;GB764” 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
HIJKBG*ALB/MA0NO

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 &(1 to plot the standard curve.

While the plot is being generated, the display shows:


P%9::68=...

The plot shows the absorbance along the vertical (y) axis, the concentration along the horizontal (x) axis, and the

28/48 User Manual HUMALYZER 3000


standard numbers along the plotted line.

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 S%$/[? To exit Multi-Point Mode and return to the main prompt,
press d"@0*DH*J>. The printer outputs “Test Ended”, and the instrument returns to the main prompt.

E?E?^*);96*#D56
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 sec-
onds. The read interval is the interval at which the intermediate readings are taken and recorded, and is fixed at
30 seconds. The !A/min. or rate of the standard will be determined by a linear regression calculation covering
the read interval. This !A/min. is printed beside S1 and is used to determine the rate factor.

Concentration of Standard = Factor !A/min.


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 !, not !A/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 de-
scribed in the section “Temperature Control”. allow a minimum of 15 minutes for the cell temperature to equili-
brate.

/.0(O*@8*926*3<49HFG6<9*34*7689*3576*3<*);96*#D56]*926*7;GB*G;I*:6*.JJ?*S6*4FH6*9D*9FH<*926*7;GB*D<*;<5
;77DN*926*3<49HFG6<9*39j4*N;HGKFB*93G6*:68DH6*49;H93<M*;*H6;C93D<?

/.0(O*S3C2HDG;93C*H6;53<M4*42DF75*:6*F465*3<*;<I*);96*#D56*9649?*$7N;I4*4676C9*;*53886H6<93;7*83796H?*a+,
<G*34*4FMM64965*8DH*H6;53<M4*;9*+V,*DH*V,^*<G?*166*926*46C93D<*eS3C2HDG;93C*)6;53<M4f?

/.0(O*L26<*F43<M*HDF<5*9649*9F:64*3<*);96*#D56]*926*9F:6*M;4=69*4FBB7365*#"10*83H49*:6*3<49;7765?

User Manual HUMALYZER 3000 29/48


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 liter (U/L) must be derived from the following standard formula:

U/L = !"#$%&'()(*+++()(,-$. x TF

MA x SVmL x LPcm

where:

U/L is units per Litre

!A/min is the mean change in absorbance per minute

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

MA is the molar absorptivity (ie, the MA of NADH at 340nm = 6.22 x 10 3)

SV is the sample volume (in ml)

LP is the cuvette light path (in cm)

TF is the temp factor used to convert assayed activity to the desired temp.

Refer to the sections “Rate by Standard” and “Fixed Time Kinetics”, below.

);96*#D56

Press Q).P)$#*TJEU*then press 5 and Enter. The display shows:

);96*SI*19;<5;H5

Rate by Standard is very similar to Rate by Factor except that the factor is determined by dividing the given con-
centration of the standard by its !A/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.

J3Y65*03G6*[3<693C4

Fixed Time Kinetics is similar to the other Rate Mode variations. However, instead of basing the final calculation
on the !A/min. of the sample, the calculation is based on the change in absorbance over the read interval. In

30/48 User Manual HUMALYZER 3000


addition, the Low Activity and Check Linearity conditions will not be displayed, and neither Batch Rate nor inter-
val data reporting is available. This is also true for Batch Rate Modes.
S;9C2*);96*#D56

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:


K$:(*Q&*RF$7:9)*9)*<:$8;$);S
/;;*<()"#1*P)(55*G8:()

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 sam-
ples 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.)

/.0(O*026*C2D3C6*9D*469*FB*CD<9HD74*5D64*<D9*8F<C93D<*3<*S;9C2*#D56?*0D*F46*;*CD<9HD7*3<* S;9C2*#D56
IDF*GF49*9H6;9*39*73=6*;*4;GB76*;<5*CDF<9*39*;4*D<6*D8*IDFH*4;GB764?

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

ekkk*(/A*.J*S$0-!*kkkf and the Rate Mode will discontinue.

);96*SI*19;<5;H5

Press* > 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 (/0(). 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 (/0(). The Wavelengths are then printed. Display Shows:

User Manual HUMALYZER 3000 31/48


Enter Lag Time (10 Seconds Minimum) and press (/0()*TJVU. 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 (<96H.

The display shows the select Units Menu. Enter the units code (0-13) and press (/0(). Press &(1 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
E?>?g*);<M64*;<5*-D<9HD74 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:

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 JV*T$--(Q0U button can be used at any time after the lag time that the user
feels there is sufficient data to report a valid result. After the instrument is finished reading a sample, there will be
three buttons at the bottom. J>*Td"@0U, JE*T#.)(U, and JV*TS%$/[U. Press the JE* T#.)(U key. The display
shows:

There are 4 Buttons now along the bottom of the display. #.A@J&*TJ>U, Q%.0*TJEU, A$0$*TJ+U, and )(0")/
TJVU.

32/48 User Manual HUMALYZER 3000


#.A@J&*TJ>U - This button is used to change the read interval. Press J>. The display shows:

The %(J0*TJ>U 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 )@P!0.
The $)).L keys allow the user to move the two lines in order to select a portion of the graph for purposes of
/01/2103%&4( !"#5%&'( 67( .%&809( :8498;;%<&'( =98;;( .[* TJVU(3<( 8&>'( ,?8( %&;392$8&3( 3?8&( @9%&3;( 3?8( &8A( !"#5%&'
and Factor.

/.0(O*$896H*GD538I3<M*49;H93<M*;<5ZDH*6<53<M*93G64]*926*BH3<9*5;9;*8F<C93D<*49377*M3R64*926*DH3M3<;7*H6;5K
3<M4?*@8*IDF*N;<9*9D*H6CDH5*926*C2;<M64]*IDF*GF49*BH3<9*926*GD538365*MH;B2?

Q%.0*TJEU - Press this key to plot and print the graph.

While the plot is being generated, the display shows:

P%9::68=...

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.

A$0$*TJ+U - Press this key at any time before pressing )(0")/*TJVU 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”.

The option*to print the data may then be taken by pressing the DATA button. The data can be examined to de-
termine 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 or Check Linearity are flagged, the interval data may still be printed by pressing the DATA
key.

#.)(*TJVU - Press this key to see other options.

In the l#.)(j menu, the display shows:

User Manual HUMALYZER 3000 33/48


Q")P(*TJEU – Press this key to purge Flowcell.

)(0")/*TJVU*– Press this key to return to sampling.

Re-Blanking may be done at any point by pressing S%$/[. To exit Rate Mode and return to the main prompt,
press d"@0. The printer outputs “Test Ended”, and the instrument returns to the main prompt.

E?+*19DH65*06494
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 23) UREA

2) BILIRUBIN DCA (Factor 12.5) 24) URIC ACID (Standard Mode)

3) BILIRUBIN DCA (Factor 58) 25) URIC ACID (Factor Mode)

4) BILIRUBIN 26) ACID PHOSPHATASE

5) CALCIUM 27) ALK PHOS

6) CHOLESTEROL (Standard Mode) 28) AMYLASE CT EPS

7) CHOLESTEROL (Factor Mode) 29) AMYLASE LIQUID

8) CREATINE 30) CK - MB

9) GLUCOSE GOD-PAP 31) CK – NAC

10) GLUCOSE HK (Standard Mode) 32) GAMMA – GT

11) GLUCOSE HK (Factor Mode) 33) GOT

12) GLUCOSE HK Hemol 34) GPT

13) HEMOGLOBIN 35) LDH

14) IRON (Standard Mode) 36) AA1 (APOA1)

15) IRON (Factor Mode) 37) AB1 (APOB)

16) MAGNESIUM 38) LPA

17) PHOSPHORUS 39) RF

18) POTASSIUM 40) ASO

19) TOTAL PROTEIN (Standard Mode 41) CRP

20) TOTAL PROTEIN (Factor Mode) 42) IGA

21) TRIGLYCERIDE (Factor Mode) 43) IGG

22) TRIGLYCERIDE (Standard Mode) 44) IGM

34/48 User Manual HUMALYZER 3000


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

E?+?>*)6C;773<M*;*49DH65*9649
Press )"/*0(10*TJ>U. The display shows a list of all available stored tests. If there is more than one page, use
the #.)( button to advance the screen to the next page. Use the numeric keys to enter the test number and
press (/0(). 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 val-
ues 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:

J5(*<:9)(;*T%$8UE

Press &(1 to use the stored blank. The stored value will be used as if it had just been read. If /.] the display
prompts to read a new blank. The display then shows:
J5(*5:9)(;*I")-(E

Press &(1 to use the stored factor or standard curve. If /. you will be asked to read new values. If recalling a
Multi-point % Abs Mode and choosing to use the stored calibration, the user will be asked to read the first stan-
dard 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:
K"8*:V(*7"))(8:*W9)U%65:E

Press &(1 to use the current stored Worklist. Select /. 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.

E?+?E*%3493<M*49DH65*96494
To print the list of all the stored tests, Press 0..%1*TJVU?*Then Press > and (/0(). This opens the Stored Data
Utilities. Again Select > and (/0(). This takes the user to the Stored User Test Menu. Select > and (/0().

E?+?+*A67693<M*;*9649
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.

User Manual HUMALYZER 3000 35/48


E?+?V*(5393<M*;*9649
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 V, Edit a
Stored Test, and (/0(). Enter the number of the test to be edited.

/.0(O*(5393<M*;*9649*N377*6H;46*;<I*49DH65*:7;<=*DH*49;<5;H5*R;7F64*8DH*92;9*9649]* ;4* N677* ;4* ;<I*B;936<9


H64F794*;<5*49DH65*H64F794*T38*;R;37;:76U?

All of the test’s parameters will be recalled and printed. The display shows:

R<:9)(;S*29;(
G;6:*F6%:()5*****31L

Press &(1 to change the filter wavelengths, or /. to continue. The instrument prompts for the primary and dif-
ferential filters to be selected.

The instrument will ask a series of questions. If choosing &(1, 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”.

E?+?^*"43<M*L.)[%@10
Press the L.)[%@10*TJ+U*Key. The Display shows the Patient ID Menu which consists of:

!" #" $%%" &" '&()*+(" ,-" .-/01)2(* 1* Use this Feature to Add a Patient. See section* eE?>?c* (<96H3<M
/;G64f. 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.

3"#"45+".-/01)2(*1*Runs the entire stored Worklist or test by test.

6"#"'/)+("(7*"85//*+(".-/01)2(*1*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.

9"#":*1*(*"&"'&()*+(";/-<".-/01)2(*1*Use the PrintOut of the Patient ID list to find the corresponding


Patient ID number that will be deleted.

="#":*1*(*"&11"-;"85//*+(".-/01)2("1*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.

!"#$%&E4&/&.0,@)&1(&13@/81<&+6)&428829135&F&813)(&/,)&<1(:8/;)<&/3<&:,13+)<%

==G'HI$&E!IJKEL==

M2,N81(+&(+2::)<>

O8)/()&,)(+/,+&+6)&92,N81(+>

#6)&+)(+&+6)3&)3<(&/3<&+6)&J0+2=H03&M2,N81(+&-2<)&1(&)*1+)<>

!2+)%&P)42,)&/<<135&:/+1)3+(&+2&/&M2,N81(+A&:,13+&+6)&.0,,)3+&M2,N81(+&BFDA&<)8)+)&/88&BQD&2,&<)8)+)&:/+1)3+&?;
:/+1)3+&BRD&+2&<)8)+)&+6)&:/+1)3+(&32&8235),&?)135&0()<A&+6)3&)3+),&+6)&3))<)<&/<<1+123/8&:/+1)3+(&BSD>&#61(
9188&:,)@)3+&;20&4,2-&,033135&20+&24&,22-&42,&:/+1)3+(&23&;20,&M2,N81(+>

36/48 User Manual HUMALYZER 3000


E?V*1B6C3;7*J6;9FH64

E?V?>*1678K-26C=
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 0..%1*TJVU, then choose V*TA3;M<D4K
93C4U. !"#$%& #6)& 7829.)88& /3<T2,& +0?)(& -0(+& ?)& ,)-2@)<& +2& 0()& +61(& 403.+123>& In the Diagnostics menu,
choose a*1678*-26C= and press*(<96H. 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.

E?V?E*J7;M4*;<5*(HHDH*#644;M64
J7;M4 are displayed to alert the operator when certain limits are approached. After displaying the warning the
instrument will continue to function normally.

kkkkk*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 neces-
sary to further dilute the sample(s), or dilute the specimen(s) and rerun the assay.

m>,kk` 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

n-")X(*@/X$%@Aoon 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
Multi-point Mode. Since this invalidates the results, the test must be restarted.

(HHDH*#644;M64

Error messages are displayed when the instrument fails to operate correctly. They are intended to help the op-
erator 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 pa-
per 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

User Manual HUMALYZER 3000 37/48


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 (/0().

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 fre-
quently, the instrument may require service.

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

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

Canceled This is displayed immediately following a filter wheel error to indi-


cate that the test or mode has been ended.

Filter Labels 7&8 Clrd! The stored filter labels have been lost or corrupted. Refer to the
section “Restore Filter Labels”.

Water Values Reset The Flowcell is active and no water values were found in memory.
The stored water values have been reset to 0.000. new water val-
ues must be read to ensure correct results. Refer to “Flowcell Con-
figuration”.

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. Re-
fer to the section “Restore Calibration Data”.

38/48 User Manual HUMALYZER 3000


+?*-%($/@/P*$/A*#$@/0(/$/-(
+?>*-76;<3<M

+?>?>*(Y96H3DH

-$"0@./O*1D7R6<94*4FC2*;4*;C69D<6*DH*923<<6H*N377*5;G;M6*926*3<49HFG6<9o*"46*D<7I*N;96H*;<5*H6CDGK
G6<565* C76;<6H4o* $RD35* ;:H;43R6* C76;<6H4?* 026* =6IB;5* ;<5* 534B7;I* ;H6;4* ;H6* 73WF35KH64349;<9]* :F9* ;H6
6;437I*4CH;9C265?

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.

+?>?E*J7DNC677
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 Flowcell cleaning solution. Allow the solution to remain in the Flowcell for 3 min-
utes.

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.

+?>?+*L;496*:D9976
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.

User Manual HUMALYZER 3000 39/48


+?E*#;3<96<;<C6

+?E?>*-;73:H;93D<*;<5*%3<6;H39I
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 instru-
ment 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 peri-
odic 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 in-
dicative 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.

MAIN PCB Power


1FBB7I

Pump

Photometer

Fan

Valve

J3MFH6*E
Remove screw* 8HDG
F<56H<6;92* 9D* H6GDR6
CDR6H

40/48 User Manual HUMALYZER 3000


+?E?E*.B6<3<M*926*@<49HFG6<9
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.

J3MFH6*+

User Manual HUMALYZER 3000 41/48


+?E?+*%;GB*H6B7;C6G6<9
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.

-$"0@./O*%;GB*34*!.0?*$77DN*926*7;GB*9D*CDD7*:68DH6*2;<573<M?

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 adjust-
ment 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 JV*T0..%1U?*Press V and (/0(). Press > and (<96H. The display
shows the voltages for each filter.

42/48 User Manual HUMALYZER 3000


J7DNC677*!;<576

1;GB76*0F:6
1FBBDH9

(Y39*0F:6
1;GB76*0F:6

TEU* pVKV,* Y* +Zc* Q;<


!6;5* 4CH6N4* NZ* 1B739
%DC=*L;426H4

J7DNC677*!;<576
S;46

TVU*pVKV,*Y*>ZV*1CH6N4

TEU*pEK^a*Y*+Z>a*1CH6N4

"BB6H*-677*SD5I

-677*L3<5DN
-677*@<46H9*1CH6N

$5qF49G6<9*169*1CH6N
J3MFH6*V

User Manual HUMALYZER 3000 43/48


J3MFH6*^

+?E?V*J7DNC677*0F:3<M*)6B7;C6G6<9
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. Re-
move 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.

J3MFH6*a

44/48 User Manual HUMALYZER 3000


+?E?^*X;7R6*0F:3<M*)6B7;C6G6<9
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.

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 tub-
ing.

Lower the cover and replace the screw.

+?+*19DH;M6
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.

• 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 pho-
tometric linearity before performing any clinical assays.

User Manual HUMALYZER 3000 45/48


V?*0)."S%(1!..0@/P

Check that the procedures and materials used were valid. Turbid or contaminated reagents may affect absorb-
ance 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.

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.

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 in-
sertion depth of the Flowcell tubes. Ensure that a leak-free seal is made.

The lamp is rated to read over 300,000 tubes, and the lamp saver feature minimises lamp idle time. Lamp re-
placement is only indicated when the lamp fails to light, or when the message “Lamp output low!” is displayed.
Press %$#Q*to turn the lamp on or off. If the lamp fails to light, refer to the section “Lamp replacement”.

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 aspira-
tion. 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 Q")P( 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.

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.
09*>(#D()$:")(*I$%6Q)$:698*>(5:
09*/T<*I$%6Q)$:698*>(5:

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.
L$)/@/PO*A.*/.0*$%0()*$/&*Q.0(/0@.#(0()*1(00@/P1*o

-2;<M3<M*92646*46993<M4*N377*G;=6*926*8;C9DHI*C;73:H;93D<*5;9;*3<R;735?

@<*926*F<73=67I*6R6<9*926*C;73:H;93D<* 5;9;* 34*7D49* DH* CDHHFB965]* 926* ;:4DH:;<C6*8;C9DH*34* 469* 9D* >?,,,* ;<5
926*96GB6H;9FH6*D88469*;5qF49G6<94*8DH*926*C677*;H6*469*9D*,?,?

AD*<D9*6<96H*R;7F64*D926H*92;<*92D46*H6CDH565*D<*926*C;73:H;93D<*7;:67*F<7644*;:4D7F967I*<6C644;HI?

46/48 User Manual HUMALYZER 3000


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: Absorb-
ance and Cell Temp. Write down these numbers.
2. Set the power switch to ./T>U.

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 0..%1*TJVU. 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 )F<*0649*TJ>U, type in 213, and press (/0()*to get a report of the calibration data. The cell tempera-
ture adjustment will be printed along with the absorbance adjustment. Make sure that these values are the
same as those recorded on the calibration label.

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.
F6%:()*M$Q(%5*XYZ*I%);N

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.
*[(&*X*65*\\\
*[(&*Z*65*\\\

where “xxx” is a three-digit wavelength value. If there are no 7th or 8th filters, they will be listed as BLOCKED.
Press )"/*0(10*TJ>U, type in 248, and press (/0(). The display prompts:

[(&*X*]**EEE*8#

Type in the wavelength for Key 7 that is printed on the label and press (/0(). Repeat for Key 8. use “000” for
unused filter positions. Press d"@0 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 d"@0 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.

User Manual HUMALYZER 3000 47/48


.926H*06494
X;CFFG*CDF<9?
The last 4 readings are averaged together and compared to 200
Greater than 203 shuts the vacuum off
Less than 197 turns it on.

-677*;<5*:7DC=*96GB*F46*926*4;G6*CF9KD88*<FG:6H4?
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

L;496*CDF<9?
A count of less than 150 is considered a full bottle condition.

The "J3796H*L2667*1B665" menu selection provides the user with the current wheel speed. The speed is set to
300 +/- 10

^?*-./0$-0*@/J.)#$0@./
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: human@human.de

• 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.

48/48 User Manual HUMALYZER 3000


Human
Gesellschaft für Biochemica
und Diagnostica mbH
Max-Planck-Ring 21 # D-65205 Wiesbaden
Germany
Telefon: +49 6122 9988 0
Telefax: +49 6122 9988 100

eMail: human@human.de
Internet: http://www.human.de

03/2004-04

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