Service Manual: Cat.-No. 16660/002
Service Manual: Cat.-No. 16660/002
Service Manual: Cat.-No. 16660/002
| Service Manual
|
Cat.-No. 16660/002
R L M
No. DATE / Rev. REVISION DESCRIPTION
1 01/2007-09 First edition
2 02/2008-04 Adaptation to new software (version 1.7.0)
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NOTICE
Analytical instruments for in vitro diagnostic application involve the handling of human samples and controls
which should be considered at least potentially infectious. Therefore every part and accessory of the respective
instrument which may have come into contact with such samples must equally be considered as potentially
infectious.
BIOHAZARD
The „BIOHAZARD“ warning label must be affixed to instrument prior to first use with biological material !
Servicing Note:
Before doing any servicing on the instrument it is very important to thoroughly disinfect all possibly contaminated
parts. Before the instrument is removed from the laboratory for disposal or servicing, it must be decontaminated.
Decontamination should be performed by authorised well-trained personnel only, observing all necessary safety
precautions. Instruments to be returned have to be accompanied by a decontamination certificate completed by
the responsible laboratory manager. If a decontamination certificate is not supplied, the returning laboratory will
be responsible for charges resulting from non-acceptance of the instrument by the servicing centre, or from
authority’s interventions.
HUMAN
Gesellschaft für Biochemica und Diagnostica mbH
| Max-Planck-Ring 21 · 65205 Wiesbaden · Germany
| Tel.: +49 61 22/99 88-0 · Fax: +49 61 22/99 88-100
| e-Mail: human@human.de · www.human.de
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1 Section I: How to Use this Manual 2
2 Section II: Maintenance Guide HumaStar 600 9
3 Section III: Nomenclature and Naming Conventions 17
4 Section IV: Chart and Block Diagrams 39
5 Section V: General Troubleshooting 63
6 Section VI: Adjust and Replacement Procedures 73
7 Section VII: Glosssary 83
8 Section VIII: Consumables and Spares 89
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Disclaimer
This manual is intended to be a reference guide to assist a trained service engineer on troubleshooting and repair
the HumaStar 600.
Information provided here is offered “as is”, it could have either typographical error and / or technical inaccuracies.
Every trained person is responsible for any risk and liability for use of this information and Human GmbH reserves
its right to do future additions, omissions or modifications without prior advice.
Revision status of this manual is the responsibility of its user.
To follow the detailed Maintenance Guide is essential for the correct function of the HumaStar 600 system.
Faceing any troubles please first revert to the information outlined in this guide.
Repairs on component level are not suggested and will not be supported.
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1 SECTION I........................................................................................................................................................................................................ 3
1.1 How to use this manual.................................................................................................................................................................. 3
1.2 Hazard Icons Description ............................................................................................................................................................... 4
1.3 Advises for Users and Service Personnel .................................................................................................................................. 5
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1 SECTION I
This document is grouped into five major sections containing different technical information:
Maintenance
Section I contains the regular maintenance procedure
General Data
Section II contains information on manual usage, product overview, accident prevention symbols and instructions,
and theory of operation.
Block diagrams
Section III contains charts, diagrams, and graphical information to complete the information provided on previous
chapter.
Appendix
Section VI provides a brief glossary, the spareparts code reference and technical specifications.
Possible injury may result from allowing part(s) of your body to enter the range of movement of
the following during instrument operation.
Potential Biohazard
− Avoid contact with tips of probes.
− Clean spills of potentially infectious materials as stated by the biosafety practices.
− Consider all specimens, reagents, controls, etc., containing human blood; and surfaces
or components that have come into contact with human blood; and the above
materials as potentially infectious.
− Wear gloves, lab coats, and safety glasses.
− Avoid contact with skin and eyes. In case of contact with skin or eyes, flush with water
at least 15 minutes. Immediately seek medical attention.
Electrostatic Sensitivity
Use caution when handling electronic components or devices sensitive to electrostatic
discharge.
− Turn off instrument before connecting or disconnecting any board to avoid circuitry
damage.
Hot Surface
Warns against possible burns from hot objects or surfaces such the reaction tray heater.
− To prevent heater harm do not use the instrument with the reaction cover removed.
− Turn the instrument off for 15 minutes to before lamp replacement.
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1.3 Advises for Users and Service Personnel
The following comments prevents problems for both user and service:
− Never install “screen savers” on HumaStar 600 computer nor enable energy-saving options from both
BIOS nor operating system (hard disk or display shut down) because they might interfere with normal
software operation.
− Check computer and / or operating system manual for further details.
− Never connect / disconnect RS-232 instrument-computer cable with the instrument on.
− It is not recommended to touch the lamp bulb nor optical filters, in case of accidental touching, bulb
should be immediately cleaned with a tissue and alcohol before turning instrument on.
− It is not recommended to keep the cover unnecessary open since this will overload the reaction chamber
heater reducing its useful life.
− It is not recommended to use the instrument without priming the hydraulics, if bubbles are observed at
inlet tubing, please purge with Maintenance > operations > hydraulic > system flush.
− It is necessary to blank the reaction tray after replace the reaction cuvettes to reset the dirty-cuvette
detection algorithm.
Note: the software will inform the user about required maintenance by screen messages.
Proceed first with daily maintenance routine. Empty and clean waste reservoir, including stopper and tubing. Clean
drain funnel in wash station. Use System Liquid and rinse with water. Clean reagent/sample tray by wiping it with
mild detergent and water. Rinse with tap water and let dry. Do not heat for drying. If desired, dry with a towel or
lint-free tissue. Clean instrument table top with a moistened cloth. Do not use organic solvents or acids. Refill wash
solution reservoir after eliminating leftover.
Purge hydraulic system from menu Maintenance / Operations, Hydraulic tab, and press System Flush.
Must be performed when the instrument indicates the need of a corrective action, or when operation anomalies
are encountered, relative to maintenance:
Hydraulic malfunction: droplet appearance on probe tip or bubbles in system.
Proceed as in section 7.10.
Message indicating replacement required.
Proceed as described on sections 7.6 to 7.9.
Poor cuvette drying or cleaning action.
Replace drying block. Perform wash unit maintenance.
When required, lamp replacement can be easily performed by the user following these instructions:
Turn off and unplug the instrument from Mains.
Remove the lamp cover on left side of instrument, lamp will be visible.
The pump tubing has a lifetime given by a pre-fixed number of work cycles.
When that number is surpassed, the instrument will show a message for tubing replacement.
At the earliest opportunity the replacement must be done (it is not necessary to stop the automatic cycle).
The drying block should be replaced if symptoms of poor drying capacity are detected or when a warning message
is displayed.
If cross-contamination is observed, first check if the drying action is effective. Poor drying implies block change.
The drying block can be replaced by unscrewing and firmly pulling it downwards until it is free, and inserting a new
one in the pipe. Reinstall the washer head and rotate new block until it mates with cuvette shape.
If this operation is difficult, remove the washer head by removing the two screws that fix it, (see picture below)
insert block and re-install wash head.
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2.7 Syringe Replacement
Instrument will warn when syringe cycles are close to its useful life, when it occurs, it is not necessary to replace it
immediately, but at the earliest opportunity the replacement shall be done.
For replacement, syringe must be all the way down, as indicated in the figure.
Select in Diluter section, Fix, volume 500 microliters either back or front diluter and press hand or F key.
initialise the system by returning to the main menu and pressing the initialisation button.
Correct hydraulic system operation is essential to obtain consistent and reproducible results.
Malfunction symptoms are:
Erratic readings and low reproducibility.
Volume dispersion in reaction cuvettes for a same method.
Droplets or drop formation on probe tip after each wash cycle.
Leaks in the system produced by defective connections or capillary obstruction by kinks or solids.
To verify, In the Result printout, the reaction cuvette number is printed. Identify cuvettes corresponding to a same
method and visually compare volumes in each cuvette.
Most common problems encountered in hydraulic system are:
Pump tubing wear introducing efficiency loss and eventual leaks. Replace tubing.
Hydraulic system obstruction. Particles present in wash solution may clog filter in pump connector. This usually
happens when metal distillers are used.
Kinks in probe arm heater tubing or defective connections.
Probe clogged by solids from samples or reagent aspiration.
IMPORTANT: Clean peristaltic pump filter and replace pump tubing on demand.
− Inspect malfunction by sections, start with pump filter, and then verify pump operation disconnecting tube from
syringe in diluter and verify dispensed volume.
− Next disconnect at heater entrance in probe arm and verify dispensed volume to detect clogging.
− Disconnect heater in probe arm from sampling capillary and repeat test.
− If probe tube is clogged, flush with the aid of a syringe or replace.
Normally obstruction will disappear by pump flush action when disconnecting and dispensing at the mentioned
points.
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Fig 1
Fig. 2
Fig. 3
− Once outside the valve, rub with fingers until standard flows normally.
− Re-install in the pinch valve by pushing the tubing and pressing delivery standard button at the same time.
− Perform procedure for valves A and B.
− Open the lower compartment in the rear panel where the ISE reagent pack and peristaltic pump are located.
− Rotate the peristaltic pump tubing rotor and gently pull tubing end as shown.
− Remove connectors.
− Re-install new tubing. Be sure that connecting tubing has no kinks. Pass them through holes, if necessary
− Do not forget to reset the ISE number of samples, as indicated in 7.1.
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2.13 Electrode Recovery
Sometimes, mainly after measuring many consecutive urine samples or if cleaning procedure is repeated several
times, slopes might decrease to values well below the stability threshold (30). Before any attempt to replace
electrodes, load the system with any serum sample and leave it in contact with the electrodes for about 30
minutes. Next, empty the module and calibrate.
Complete procedure should be as follows:
When Na+ calibration slope slips down (below 30), Na+ instability or more than 15 days elapsed since treatment
messages are displayed, a cleaning cycle is recommended, but using the Na conditioning solution instead of regular
cleaning solution. Use Cleaning button. Next, perform a Startup cycle.
Note: at least once a year the instrument covers should be removed and the dust collected inside must be cleaned
off carefull from fans, mechanics and electronics.
− Bold-Italics font is used to show a sequence of menus, options or sections to perform certain task.
(E.g. Maintenance > Operations > Hydraulic > System flush).
− When a parameter is mentioned, Bold-Italics font is used to show required sequence to locate the
parameter and parameter is written in bold font only. (E.g. Maintenance > Parameters > Software >
General > Communication > Port number).
This code is required to order a board from manufacturer, because some functions are done by identical boards
with different components (e.g. generic motor controller or filter wheel motor controller).
3. Pin 1 mark: to identify the first pin in connectors, notice white dot on serigraphy face. In case of single-in-
line connectors, adjacent pins are numbered increasing.
For dual in-line connectors, first pin is dotted, second is the opposite, third is next-opposite and so on.
•
3
5 •
7 2
9 3
4
2 5
4
6
8
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4. Flat wire connections: All flat wire must be connected to match first connector pin to marked wire (red or
black).
The HumaStar 600 is composed by a set of robotics and dispensing devices divided in two channels, Front and Back.
This arrangement provides both speed and redundancy to ensure backup mode operation.
Each channel includes the following devices:
- Diluter
- Probe assembly
- Reaction tray
- Dual beam photometer reading channel
- Peristaltic pump for cuvette washer
- Probe tip cleaning pump
- Reaction aspiration pump
- Drying pump
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3.3 Components Detail
3.3.1 Sample and Reagent Trays
Sample and reagent trays are driven by stepper motors capable of rotate in both clockwise and counter-clockwise
direction.
Home of tray reference is given by an optical switch, for positioning verification purposes, an additional optical
sensor with slotted-wheel set, provides detection on loose of steps.
Detection and recognition of samples is provided by a barcode mounted on the outer border of sample tray.
3.3.4 Diluters
Two diluters have a 500uL syringe each and aspirate reagent and sample consecutively. Air gaps separate liquids to
prevent early mixing and contamination.
3.3.5 Photometer
The double beam photometer is provided with 12 interference filters mounted in a rotating filter wheel, with
reference channel.
Light from a tungsten halogen source passes through the selected filter and a beam splitter set divides beam in
three paths.
One beam traverses the reaction cuvette of front reaction tray, the other one through the cuvette for back reaction
tray; the third one is directed towards a reference detector.
The reading is obtained as the ratio of each signal to the reference signal, and the system is therefore immune to
source fluctuations, filter variations or dirt accumulation on optical surfaces.
This double beam design allows the detection of reaction cuvettes in the reaction tray setting an alarm when
cuvettes are missing or defective.
Each device has internal parameters to be loaded for ensure proper operation (e.g. allowed maximum speed,
required acceleration profile, configuration of sensors, internal data, internal delays, timeouts, etc).
Parameter information is contained on the eeprom memory of the concentrator and it is sent to the device during
the instrument power-on.
When the computer is performing the connect procedure to recognise the instrument, a backup of both
concentrators eeprom contents is stored on harddisk.
On the event of concentrator parameter or memory corrupted the computer will automatically restore the latest
available backup.
Except for the filter wheel motor controller, any other motor controller boards is generic and completely
exchangeable, although they have different programs and parameters according the task to perform, they
automatically recognise their function identifying the slot currently installed during power up.
Checking any motor controller board involves just exchanging with another one.
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NOTES:
PREAMPLIFIER REF
ADDR 0103h
BARCODE
ISE OPTION OPTION
PC ADDR 011Ch ADDR 0120h
RS-232
ADDR 0000h
RS-485 RS-485
CONCENTRATOR 1
ADDR=01FFh RS-232
TTL
CONCENTRATOR 2
ADDR=01FFh
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3.6 Protocol Overview
Communication is first established when the computer sends a request packet containing a command to the
specified device attached to the specified concentrator.
After checking the valid device address, concentrator will answer with an acknowledge packet and will forward a
short packet to the device containing both commands and required parameters.
When command is completed, device will produce a response packet to the concentrator which will be translated
into an answer packet to the computer.
Once the computer receives the packet it will produce another acknowledge packet for the concentrator.
Detection of missing packets is achieved using packet counter for computer (PC_PKT#)m for C1 (C1_PKT#) and C2
(C2_PKT#).
− When the computer sends a request, the acknowledge packet will contain the same packet number
provided by the computer.
− The answer packet will contain the packet number of the specific concentrator and the further
acknowledge from the computer will repeat the same packet number.
3.8 C1 Protocol
Concentrator 1 includes one RS-232 port specifically for the bar code reader, a RS-485 port for the preamplifiers,
and another RS-485 port sharing a common protocol for the temperature controllers, diluters, photometer motor
controller and the protocol translator unit for the ISE module.
When computer to instrument communication is analyzed two different bit streams are provided for
understanding the operation.
The high level communication only contains the commands, parameters, and answers from the device, useful for
the service diagnostic (see section I, understanding errors.log).
The low level communication includes all kind of packets transmitted between the instrument and the computer,
including requests packets, acknowledge to request packets, answer packets, and acknowledge to answer packets.
Also each packet complete contents is shown including packet numbers and crc values.
A detailed description on low level communication is out of the scope of this manual.
3.11System Tests
3.11.2 Noise
This test determines the departure of individual readings from the mean value. Noise is evaluated separately from
derive. For stability evaluation, total time (Number of readings X Time interval) should be at least 10 minutes. Noise
evaluation is performed without moving tray and data are directly related to photometer behaviour.
When Absorbance correction is selected (recommended for solutions and not for filters), results are expressed as
equivalent to 1 cm cuvette measurements.
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Noise test is relevant for absorbances over 1.300. Potassium Chromate (1.2 to 1.5 g/l in acidic media) is
recommended. Relevant data are peak-to-peak (maximum) difference. They should not exceed 0.002 for 1 minute
total time.
3.11.3 Stability
Stability test is very similar to noise test, but the tray is randomly moving between readings. Comparison of data
from noise and stability tests can give a hint on mechanical positioning problems. Use conditions as described in 0.
Washer hydraulics
S1 S2 S3 S4 S5 B
D1 D2 D3 D4
draining reaction off
dispensing
draining water off
drying block
3.11.4 Washer
Washer test consists of performing cuvette cleaning cycle on a programmed number of cuvettes. Absorbances are
read on new cuvettes before cleaning action, immediately after cleaning and at some fixed time (Drying time). All
three data are shown in the graph.
If cuvettes are properly dried and not scratched by the system, values should return to the original ones, with a
tolerance of about 0.003 abs.
3.11.5 Dilution
Dilution test should be performed with a sample of Potassium Chromate of 2 g/l in acidic solution. Use as reagent
the tip washing solution.
For a final volume of 4/400, CV should be less than 1.5%.
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3.11.10 User operation of System Modules
Enter to Maintenance > Operations to perform habitual maintenance tasks (e.g. purge hydraulics after wash bottle
refill, reset counters after consumable parts replacement) or perform tasks requiring operation of serveral devices
(e.g. complete dispensing cycle).
Hydraulic tab:
Photometer tab:
Motors tab:
− Perform general
operations involving
− sample/reagent/reaction
dispensing
− tip pumping
− photometer readings
− diluter operation
− cuvette washer
Notes:
On washer operation wash means normal mode, only dry is drying+aspiration,
only pump for dispensing and only go to move it.
For diluter operation, diluter fix means absolute position, diluter in and out
means relative position.
Versions tab:
Wear tab:
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3.11.11 Operation of manual movements
This mode allows a quick testing of each single device to obtain additional information when user is unable to
describe the specific issue. Click on Data > Log as Service > type password 31415 then Maintenance > service >
manual to see a window having tabs to access all available modules: Vertical, Horizontal, Trays, Pumps, Washing
stations, Temperature, Diluters, BCR, Photometer, Filter wheel, Steppers, Cool tray, Options, and Stress.
On the right, another two windows display the high level (command level) communication and low level (packet
level) communications, use right mouse button to open packet interpreter window and see communication details.
(See section I, protocol overview).
Vertical tab:
Trays tab:
Pumps tab:
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Washing stations:
Temperature tab:
Valve positions:
− bypass is pump to tip
− input is pump to syringe
− output is syringe to probe
BCR tab:
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Photometer tab:
development only screen
Unblock on stop: set to 0 for blocking movement when stop (set to 1 to release on stop)
Collision sensor: collision polarity detector, when instrument is giving continuously collision toggle the bit to
disable collision detection.
FRT
8=Led0 9=Led1 10=Led2 11=MotorOn
BRT
0=Lamp 8=Led0 9=Led1 10=Led2 11=MotorOn
ST
8=Led0 9=Led1 10=Led2 11=MotorOn
RT
8=Led0 9=Led1 10=Led2 11=MotorOn
HF
8=Led0 9=Led1 10=Led2 11=MotorOn
HB
8=Led0 9=Led1 10=Led2 11=MotorOn
VF
1=Mixer 8=Led0 9=Led1 10=Led2 11=MotorOn
VB
1=Mixer 8=Led0 9=Led1 10=Led2 11=MotorOn
PF
0=TipPump 8=Led0 9=Led1 10=Led2 11=MotorOn
PB
0=TipPump 8=Led0 9=Led1 10=Led2 11=MotorOn
WF
0=Station1 1=Dryier 2=St2, St3, St4 8=Led0 9=Led1 10=Led2 11=MotorOn
WB
0=Station1 1=Dryier 2=St2, St3, St4 8=Led0 9=Led1 10=Led2 11=MotorOn
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Cool tray tab:
Options tab:
Lets the user send a command to the
instrument.
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4 SECTION IV.................................................................................................................................................................................................... 41
4.1 Chart and block diagrams ............................................................................................................................................................. 41
4.2 Location of belts and sensors ..................................................................................................................................................... 55
4.3 Hydraulics Schematics ................................................................................................................................................................... 58
4.4 Complementary Information ...................................................................................................................................................... 59
4.4.1 Identification of system leds...................................................................................................................................................... 59
4.5 Computer program folder contents.......................................................................................................................................... 61
4.6 Main menu user messages........................................................................................................................................................... 61
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4 SECTION IV
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Reaction tray– bottom view
Washer hydraulics
Probe hydraulics
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4.4 Complementary Information
4.4.1 Identification of system leds
On each power supply Green led Power good signal from power supply
Power on push button Red lamp Blinks on a power supply fault event
+36_1/Red 36v on J21*
+36_2/Red 36v on J20*
Backplane board
+36_3/Red 36v on J60*
PL400245
+36_4/Red 36v on J57*
+12/Green 12v on J72*
Bar code reader interfase
DL1/Green Read Ok
board
DL2/Red Read order / init to BCR
PL230224
Power from standby power supply
RS232 to RS232 Isolated
+5vPC/Red (allways on)
board
+5vCPU/Red Power from CPU board (on when
PL400282
instrument is on)
Microconverter baseplane & DL1/Green +12 input
Power supply board DL2/Red +12A output
PL400248 DL3/Red -12A output
+12v cooler led/Red
+12v lamp led/Red Power good from power supply
+36v heater led/Red Power good from power supply
+36v Motor II led/Red Power good from power supply
Power good from power supply
Power ON/OFF control board +36v Motor I led/Red
+12v Logic led/Red Power good from power supply
PL400255
+24v Diluters led/Red Power good from power supply
Cooler activated led – Solid state Power good from power supply
relay/Red JP1: cooler pushbutton bypass
Mains activated led – Solid state JP2: mains pushbutton bypass
relay/Red
+12
DL1/Red
Ise busy
ISE protocol interfase board DL2/Red
RS485 Cavro Blink (development
PL400268 DL3/Red
purposes)
DL4/Red
Trigger 1 (development purposes)
DL1/Red Power on J12/J13: Peltiers
Cooler control board
DL2/Red Power on J14/J15: Peltiers
PL400269
DL3/Green +12
Lamp Control board
DL1/Red Lamp on signal
PL400273
Notes:
* Remove all motor controller boards to perform led checkings (any motor controller internally wires J21 to J20 and
J60 to J57 depending its position on backplane).
To obtain the program folder press the right button on the HumaStar 600 icon and choose properties.
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4.5 Computer program folder contents
MESSAGE OPERATION
On line Instrument is ready to process commands.
Operating Instrument is busy.
Connecting Computer trying to set the link to the HumaStar 600.
Offline Computer was not able to connect to the instrument.
System log Instrument was unable to recover from an error - A fatal error occurred.
System Alerts User attention required.
Reaction tray Full Washer is disabled and no empty cuvettes available.
Reaction pending Acc. Awaiting confirmation of result by the user.
Calculated pending Acc. Awaiting confirmation of calculated result by the user.
Reagent blank pending Acc. Awaiting confirmation of measured blank by the user.
PreAutomatic Instrument performing hydraulic priming and reaction tray heater warm up.
Instrument processing samples (cuvette checking, reagent level checking,
Automatic
processing of blanks, standards, controls and samples).
Instrument washing used cuvettes and cleaning the probes with wash and
Post-Automatic
soak solutions
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5 SECTION V: GENERAL TROUBLESHOOTING
5.2.4 Colorimetrics with proper dispersion but values too high or low
− Verify standard, compare calculated factor with stored (historic) factors, and recalibrate method. If
problem persists, replace standard and/or reagent.
− Clean probe and check for cross contamination by changing the order of dispensing (“Time priority for
reagents” parameter). Check proper probe washing/clean probe.
− Check for exceeded method linear range; compare method definition with reagent specification.
− Verify sample volume is not excessive.
− Perform stray light verification, high range and low range linearity test, and dilution test.
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− Replace lamp, align lamp, clean filters verify reaction tray positioning.
5.2.9 Kinetics with values too low or too high on the whole range
o
− Verify if factor matches selected temperature. Remember selected temperature is usually 37 C.
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5.3.5 VD-05: Photometer calibration check
− Enter to Data > Log as service > password 31415, then Maintenance > Calibration > Filterwheel.
− Press start and check that peak for each filter and channel is centered (Ignore saturating channels) – see
image below.
− By changing the delay the peaks can be optimized in the center.
− Filter 13 is blocking (no signal) and may show no main peak.
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5.3.7 VD-07: Instrument general status check
Choose maintenance > electronic status, instrument will show its internal status as shown below:
Board status
FRTW Temperature: 36 ºC Voltage: 37
BRTW Temperature: 32 ºC Voltage: 37
SRT Temperature: 43 ºC Voltage: 36
FBPP Temperature: 32 ºC Voltage: 37
FVH Temperature: 35 ºC Voltage: 37
BVH Temperature: 33 ºC Voltage: 36
Cooler thermostat: Ok
Concentrator 2: Ok
Note: When no faulty tubing is identified, use the tubing kit to externally
bypass each tubing and repeat the test to isolate the faulty one.
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5.3.12 VD-12: Probe robotics check
− 1. Reset instrument (press red pushbutton).
− 2. Gently move the probe from side to side and up to down checking movement is smooth without jams.
Use a syringe to inject light oil and lubricate bushings if required.
− 3. Ensure that neither flag or disc touch optocoupler sensor body.
− 4. Compare zero and verification led blinking against the other probe.
− 5. Swap front/back motor controllers boards. Check connections.
− 6. In case of step loss: Check for belt damage (e.g. cracked belt surface or missing teeth), loose pulley to
rod joint or heavy motor.
− Enter to Data > Log as service > password 31415 then enter to Maintenance > Service > Manual select
stress tab.
− Select movement or operation to test.
− Set movements to 100, press white hand button to start
− Review results on errors.log file
When complete tray and arm movement test is required, use Maintenance > system test > Level detection.
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Initialize instrument.
Photometer
This calibration will determine the optimum reading position in the middle
of each cuvette.
− Select Front Tray, remove cuvette cover.
− Press F1 function or Start button
− Use buttons or letters Q and E in keyboard until cuvette number 3 is close to
− Photometer position. Use 10 steps or 1 step option as required. Photometer
− position is labeled with an arrow.
− Close cover
− Press Scan button. Instrument will scan cuvette number 3 and in Position
− window will write optimum calibration value.
− Press F3 function or Confirm button.
− Select Back Tray and repeat procedure.
If instrument was already calibrated, Last button will position tray where last calibration was determined. This
procedure will save time and item 3 can be skipped.
Once Start button is pressed, calibration can be aborted by pressing the Skip button.
Note: Last button does not act on vertical positions. This prevent tip damage.
If instrument was already calibrated, Last button will position tray where last calibration was determined. This
procedure will save time and item 3 can be skipped.
Once Start button is pressed, partial calibrations can be aborted by pressing the Skip button.
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Arm and Sample
− Select Front Probe.
− Press F1 function or Start button.
− Use buttons or letters A and D in keyboard until tip is close to the center of inner sample ring. Use 10-step
or 1-step option as required.
− Rotate Sample tray by using buttons or keys Q and E in keyboard.
− Repeat 3 and 4 until tip is in the center of sample vial number 1.
− Press F3 function or Confirm button.
− Use buttons or letters W and S until tip just touches bottom of sample
vial.
− Pull up frequently the vial while stepping down
− Press F3 function or Confirm button.
− Use buttons or letters A and D in keyboard until tip is close to the
center of outer sample ring. Use 10-step or 1-step option as required.
− Rotate Sample tray by using buttons or keys Q and E in keyboard.
− Repeat 3 and 4 until tip is in the center of sample vial number 2.
− Press F3 function or Confirm button.
− Use buttons or letters W and S until tip just touches bottom of sample vial. Pull up frequently the vial
while stepping down
− Press F3 function or Confirm button.
− Select Back Probe and repeat procedure.
If instrument was already calibrated, Last button will position tray where last calibration was determined. This
procedure will save time and items 3, 4, 9, and 10 can be skipped.
Once Start button is pressed, partial calibrations can be aborted by pressing the Skip button.
Note: Last button does not act on vertical positions. This is so to prevent tip damage
Reagent Tray
− This calibration is intended for alignment of reagents into the removal area.
− Press F1 function or Start button.
− Rotate Reagent tray by using buttons or keys Q and E in keyboard
until Reagents 1 and 25 are visible in the load area.
− Re-adjust until reagents 1 and 25 can be loaded and unloaded
through the loading area.
− Press F3 function or Confirm button.
− If instrument was already calibrated, Last button will position tray
where last calibration was determined. This procedure will save time
and item 1 can be skipped.
− Once Start button is pressed, calibration can be aborted by pressing
the Skip button.
If instrument was already calibrated, Last button will position tray where last calibration was determined. Once
Start button is pressed, partial calibrations can be aborted by pressing the Skip button.
Repeat above steps for bottle position 25 as well.
78
ISE Module
The following procedure includes tip introduction in serum when it is delivered in cup. This reduces serum
carryover when releasing the cup:
− Press F1 function or Start button.
− Use buttons or letters A and D in keyboard until tip is close to the center of ISE loading window. Use 10-
step or 1-step option as required.
− Press F3 function or Confirm button.
− Use buttons or letters S and W in keyboard until tip touches the bottom of the loading cup. Use 10-step or
1-step option as required.
− From the bottom of the cup, move the tip 30 steps up.
− Press F3 function or Confirm button.
− Use buttons or letters A and D in keyboard until tip is close to the center of ISE priming position. Use 10-
step or 1-step option as required.
− Press F3 function or Confirm button.
− Use buttons or letters S and W in keyboard until tip is in the bottom of the ISE priming position. Use 10-
step or 1-step option as required.
− Press F3 function or Confirm button.
Note: Last button does not act on vertical positions. This is so to prevent tip damage.
Photometer Calibration
Photometer calibration consists of automatic adjustment of gains for front, back and reference channels. Also,
energy ratios front/reference and back/reference are evaluated.
Ratios are used for absorbance calculations.
Calibrations must be performed only when lamp is changed or filters are cleaned or replaced.
Channel Ratio must be re-calculated about once every two weeks.
When calibration or ratio evaluation is started, instrument asks for a new cuvette in position 1.
When calibration is performed, error messages will be issued if gains are too high or too low.
No conditions are established on ratios.
Sample sector definition
For sector definition, select Maintenance > Calibration > Sector definition, then define a new sector with a number
and assign the STAT condition, if required. Be sure that number is not already defined in the column to the right. If
so, first delete definition and then re-enter new definition, including STAT condition.
− Initialize instrument. Enter to Data > Log as service > password 31415
− Access to Maintenance > Service > Manual and choose vertical tab.
− Initialize vertical and press turn on vibrator button.
− Check the probe mixer adjustment:
Movement amplitude for mixer is three times the diameter of probe tip.
80
− Identify and remove two screws located on washer fixture.
− 1. Identify collision sensitivity screw. Rotate clockwise to reduce washer collision sensitivity.
WARNING:
This is a factory adjustment and it should not be modified unless a major servicing is required (motor
replacement, sensor position adjust, etc.)
Do not use if a filter is replaced. This procedure will reset preamplifiers gain, photometer calibration is
further required.
− Enter to Data > Log as service > pasword 31415, then Maintenance > Calibration > Filterwheel.
− Remove all cuvettes from light path.
− Choose reset gains and set reset delays to 20, use normalization by channel and then press start.
− Choose main delay to see noise on filter # 13
− Adjust each filter delay to center the three signal peaks (use stay on filter option).
− Press stop button when done.
In case readings of front, back and ref channels are not similar, perform adjustment of filters delay (AR-18). In case
issue persists, check lamp alignment (VD-06).
− Enter to Data > Log as service > password 31415 then enter to Maintenance > Calibration > Lamp
intensity
− Choose reading for filter #1 and press start button.
− Re-adjust of lamp socket to maximise reading while getting both channels as equal as possible.
− For testing purposes it is possible to stop filter wheel and then return it to normal mode.
82
C
7 SECTION VII................................................................................................................................................................................................... 85
7.1 Glossary................................................................................................................................................................................................ 85
7.2 General parameters ........................................................................................................................................................................ 87
7.3 Technical specifications................................................................................................................................................................. 88
8 SECTION VIII ................................................................................................................................................................................................. 89
8.1 Consumables and Spares .............................................................................................................................................................. 89
84
7 SECTION VII
7.1 Glossary
Absorbance. Absorbance, or optical density, is a measure of the amount of light absorbed by a solution.
Absorbance is equal to the logarithm of the ratio of incident light to transmitted light.
Acceptance. The action of approving or rejecting the result of an assay. Used by the operator to confirm calibrations
or out of range assays results.
Accuracy. The closeness of the result of a measurement to the true value.
Aliquot. A measured portion of a sample taken for analysis.
Analyte. A specific compound or element of interest undergoing chemical analysis.
Batch. A quantity of material produced or processed in one operation, considered to be a uniform discrete unit.
Batch-sample. One of the samples drawn from a batch.
Batch-size. The number of samples in a batch-lot.
Bichromatic measurement. The subtraction of a secondary wavelength absorbance reading from a primary
wavelength absorbance reading to obtain a delta absorbance reading.
BRTW. Back reaction tray and washer.
BVH. Back vertical & horizontal.
Calibrate. To determine, by measurement or comparison with a standard, the correct value of each scale reading on
a meter or other device, or the correct value for each setting of a control knob.
Calibration curve. The graphical relationship between the known values for a series of calibration standards and
instrument responses.
Calibration drift. the difference between the instrument response and a reference value after a period of time
without recalibration.
Calibration standard. A substance or reference material used to calibrate an instrument.
Certified Reference Material. A material that has been certified for accuracy, stability and physical form.
Coefficient of variation (CV). A measure of relative dispersion (see precision). It is equal to the ratio of the standard
deviation divided by the arithmetic mean.
Concentration. The concentration of an analyte is a measurement of the amount of mass of the analyte per unit
volume or weight. The mass may be expressed in grams, moles, international units (IU), or other units. The liquid
volume may be expressed in milliliters or other units of volume. Sometimes only the total mass of the analyte is
used.
Control limits. A range within which specified measurement results must fall to be compliant.
Control Specimen. A control specimen is material from a single pool of unknown specimen(s) from which an
aliquot is measured every analyte run to monitor assay to assay reproducibility and to provide an indirect
measurement of the performance of the assay components.
Correlation coefficient. A number between -1 and 1 that indicates the degree of linearity between two variables or
sets of numbers. The closer to -1 or +1, the stronger the linear relationship between the two (i.e., the better the
correlation.) Values close to zero suggest no correlation between the two variables.
Dilution factor. Indicate the ratio between the original concentration and the new dilution concentration. Used
when analyte concentration is too high and sample have to be diluted in order to perform the assay. A typical
dilution of 1 part of sample in 10 parts of final solution, is commonly represented as 1:10 (1 in 10) or 1+9 (1 plus 9).
Duplicate. A second aliquot of a sample that is treated the same as the original sample in order to corroborate the
obtained result.
Eeprom. Electrically erasable and programmable read only memory.
End Point Measurements. End point measurements are measurements of a reaction, which is made at a fixed time,
usually after the reaction has been completed.
Error Message. An error message is a warning which is displayed whenever an error occurs during the operation of
the program. A record of the type of error, its location, and its cause is stored in the Errors.Log text file.
External quality control. The activities which are routinely initiated and performed by persons outside of normal
operations to assess the capability and performance of a measurement process.
86
7.2 General parameters
Filters. Wavelength definition of installed filters. There are 14 filter positions. Position 0 is always reserved to
blocking (zero) filter and cannot be modified. For change, write in the right window new value and press button.
A zero value in wavelength for positions 1 to 14 means that the position is not used, regardless there is a filter or
not.
Others.
Temperature
Front and back arms. Recommended range: 40 to 43 °C
Reaction Tray: 37 to 39oC
Cool tray: 7 (low) to 8 (high) °C.
Pre and post-wash
Delivered volume with pumps when anti-interfering options are in effect.
Recommended volume: 100
Recommended speed: 4320
Cuvette blank.
Limits and tolerance in the cuvette test. Tolerance refers to the allowed variation in each individual
cuvette from the initial reading before being considered dirty.
Low limit (abs): 0.010
High limit (abs): 0.200
Tolerance (abs): 0.040
Pumps
Parameters which define the tip wash. They are valve opening times and are measured in
milliseconds.
External wash: 750 milliseconds
System flush: 4750 milliseconds
Decompression: valve pre-opening time for pressure release purposes: 250 milliseconds.
Wear
Factory recommendation for warning on consumables expected life.
Each parameter, when surpassed, triggers a warning message. The warning message presence does
not prevent from instrument usage.
Washing station
Defines delivered water in cuvette wash stations. Water is delivered in four cuvettes at the same
time, between 500 and 700 microliters in each one. So, total volume is between 2000 and 2800
microliters. Calibration is in step of peristaltic pumps. Each pump turn corresponds to 400 steps.
ISE
Enables/Disables the option
Time pinch valves are open. Defines delivered volume of standards A and B. Its value must be
adjusted to get a delivery of180 l.
ISE Thresholds
Define values in millivolts for detection of different fluids.
Throughput: Reagents:
450 tests/hour double reagent, 600 tests/tour Maximum number of simultaneous tests: 24
mono reagent, max. 770 tests/hour with optional double to 48 single reagent tests + 3 with optional
ISE unit. ISE unit.
1 to 3 reagents, 5 to 500 µL/test each (in
Analysis Modes: increments of 1 µL), final total solution volume
180 to 500 µL/test
End point with sample or reagent blank.
Reagent bottles capacities: 25 and 70ml.
Factor or standard.
Reagent cooling compartment: 48 cooled positions.
Priority selection by sample (profile) or by reagent
(batch).
Calibration curve with up to 10 standards. Reaction:
Automatic curve fit. Water consumption: 4 L / hour.
Turbidimetry. Warm air incubator: 37°C.
Fast and two-point kinetics (zero and first order). Reaction cuvette: re-usable plastic 6 mm path light
cuvettes
Routine, batch, STAT procedures, profiles.
Reaction time: 0 to 10 min.
Enzymes. Drugs.
Reaction temperature: 37°C ± 0.1°C.
Automatic sample dilution on abnormal levels,
excessive substrate consumption and/ or lack of Stirring: After dispensing each reagent.
linearity.
Full quality control: Levy-Jennings plots, Westgard Optic System:
multirules. Double beam
Import/export data, methods and historic files. Photometric Range: -0.1 to 4.0 A.
Automatic backup procedure. Measuring wavelength: 340 to 750 nm (selectable
Test selection, automatic calibration, calibration among 12 wavelengths).
curve, multipoint calibration, polygonal. Photometry: Single or Double-wavelength
Serum indices: sample blank compensation, simultaneous reading.
calculated tests, Quality control, auto re-run,
prozone check, record of calibration, data storage
ISE Unit:
(historic results). + + -
Na , K and Cl measurements.
Automatic pre-dilution and post-dilution (ratio 1:5
to 1:100) Samples: serum
88
8 SECTION VIII
BELTS
16660/60 COBERG17 1 Vertical Mov. Probe
16660/61 COBER090 1 Horizontal Mov. Probe
16660/62 COBERG14 1 Reaction Tray
16660/63 COBERG11 1 Reagent Tray
16660/64 COBERJ550 1 Sample Tray
16660/65 COBERG80 1 Cuvette Washer
STEPPER MOTORS
16660/50 OT301ASMW4 1 Reaction tray
16660/51 OT103H72 1 Sample tray
16660/52 OT103H72 1 Reagent tray
16660/53 OT025CP1 1 Cuvette washer
16660/54 OT025CP1 1 Movement vertical probe
16660/55 OT025CP1 1 Movement horizontal probe
16660/56 OT301ASMW4 1 Peristaltic pump
16660/57 OT103547W4 1 Photometer
16660/58 OT301ASMW4 1 ISE Pump.
PHOTOMETER
16660/30 M24F02BW-340 1 Filter w/holder wl: 340 nm
16660/31 M24F02BW-380 1 Filter w/holder wl: 380 nm
16660/32 M24F02BW-405 1 Filter w/holder wl: 405 nm
16660/33 M24F02BW-450 1 Filter w/holder wl: 450nm
16660/34 M24F02BW-490 1 Filter w/holder wl: 490 nm
16660/35 M24F02BW-505 1 Filter w/holder wl: 505 nm
16660/36 M24F02BW-550 1 Filter w/holder wl: 550 nm
16660/37 M24F02BW-590 1 Filter w/holder wl: 590 nm
16660/38 M24F02BW-620 1 Filter w/holder wl: 620 nm
16660/39 M24F02BW-650 1 Filter w/holder wl: 650 nm
16660/40 M24F02BW-700 1 Filter w/holder wl: 700 nm
16660/41 M24F02BW-750 1 Filter w/holder wl: 750 nm
16660/42 M400BF02AW 1 Beam Splitter Sample
16660/43 M400BF02BW 1 Beam Splitter Reference
DILUTER
16660/20 VOSB1205 1 Complete diluter
16660/21 VOSB1206 1 Syringe CAVRO 734804
16660/22 PL400284W 1 Diluter interface pc board
16660/23 VO729370 1 Diluter valve for VOSB1205
16660/24 VO734813 1 Plunger repair kit for VOSB1206
16660/25 VO737300 1 Board for VOSB1205
VO730896W 1 Dilutor Control Board incl. RS232
90
16660/111 PL400286W 1 Pre-heater (M400-P286)
16660/112 PL400255W 1 Power on-off control (M403-P255)
16660/113 PL400256W 1 Single sensor board (M400-P256)
16660/114 PL400257W 1 Flip single sensor board (M400-P257)
16660/115 PL400279W 1 Two sensor board (M400-P279)
16660/116 PL400280W 1 Flip sensor board (M400-P280)
16660/117 PL400287W 1 Front vertical & horizontal dist. (M400-P287)
16660/118 PL400288W 1 Back vertical & horizontal dist. (M400-P288)
16660/119 PL401262W 1 Front reaction tray & washer dist. (M401-P262)
16660/120 PL401263W 1 Back reaction tray & washer dist. (M401-P263)
16660/121 PL400281W 1 Sample-reagent tray dist. (M400-P281)
16660/122 PL402268W 1 ISE Controller (M402-P268)
16660/123 PL400269W 1 Cooler control (M401-P269)
16660/124 PL400272W 1 Thermostat support ( M400-P272)
16660/125 PL400273W 1 Lamp source (M400-P273)
16660/126 PL401282W 1 RS232 to RS232 Isolated (M401-P282)
16660/127 PL400283W 1 Pumps distribution board (M400-P283)
ISE MODULE
16660/3 MODISE103 1 ISE module Na, K, Cl
16660/1 VA0000SI 1 Solution pack (1300 tests)
16660/4 EDISENA 1 NA electrode
16660/5 EDISEK0 1 K electrode
16660/6 EDISECL 1 Cl electrode
16660/7 EDISREF 1 Ref. Electrode
16660/8 TUBISE 1 ISE valve tubing
02/2008-04