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Service Manual: Cat.-No. 16660/002

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HS 

| 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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ii
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
2/2
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

2
1 SECTION I

1.1 How to use this manual

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.

Verification and diagnostic procedures


Section IV contains details on verification, checks, tests, adjustments, calibrations, required to verify instrument
operation and troubleshooting.

Adjust and replacement procedures


Section V contains replacement procedures and required adjust activities.

Appendix
Section VI provides a brief glossary, the spareparts code reference and technical specifications.

3 Human HumaStar 600 Service Manual


1.2 Hazard Icons Description

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.

Class 1 Laser Product


Warns against direct viewing into the light beam of barcode reader.

Electrical Shock Hazard


To protect against electrical shock, use only approved power cords and electrical accessories
such as those supplied with the Analyzer. Connect power cords only to properly grounded
outlets.
If water or reagents splash on the Analyzer, immediately power off the Analyzer at the Main
Power Switch. Failure to power off the Analyzer may result in electrical shock or fire.

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.

− HumaStar 600 turn on / off sequence is:


− Turn on: 1) HumaStar 600 2) Printer and others 3) Computer
− Turn off: 1) Computer 2) Printer and others 3) HumaStar 600

− 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.

5 Human HumaStar 600 Service Manual


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2 SECTION II: M AINTENANCE GUIDE H UMASTAR 600 ................................................................................................................................9


2.1 Weekly Maintenance Routine ........................................................................................................................................................9
2.2 Quarterly Maintenance Recommendations (service only) ..................................................................................................9
2.3 Maintenance on Demand ................................................................................................................................................................9
2.4 Lamp Replacement .............................................................................................................................................................................9
2.5 Pump Tube Replacement .............................................................................................................................................................. 10
2.6 Dryer Block Replacement .............................................................................................................................................................. 10
2.7 Syringe Replacement ...................................................................................................................................................................... 11
2.8 Maintenance of Hydraulic Circuit (service only)................................................................................................................... 11
2.9 Photometer and Filter Cleaning (service only) ...................................................................................................................... 12
2.10 ISE Maintenance ............................................................................................................................................................................... 12
2.11 Pinch Valve Unclogging ................................................................................................................................................................. 14
2.12 Pump Tubing Replacement .......................................................................................................................................................... 14
2.13 Electrode Recovery........................................................................................................................................................................... 15
2.14 Sodium Electrode Conditioning.................................................................................................................................................. 15
8
2 SECTION II: MAINTENANCE G UIDE H UMASTAR 600

Note: the software will inform the user about required maintenance by screen messages.

2.1 Weekly Maintenance Routine

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.

2.2 Quarterly Maintenance Recommendations (service only)

Optical Filters cleaning. See section 7.11.


Replace washing solution aspiration tube. The PVC tubing should be replaced, as fungus and algae formed may
clog the system. A quarterly basis for replacement may seem short, but microscopic formation may have already
started.
Cleaning of washing solution reservoir.
Clean the reservoir and stopper with Solution 1. Rinse with abundant tap water followed by DI water. Replenish
reservoir and perform 2 filling cycles.
Purge hydraulic system from menu Tools / Maintenance, Hydraulic tab, and press System Flush.

2.3 Maintenance on Demand

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.

2.4 Lamp Replacement

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.

− Press lever on the lamp socket to remove burnout lamp.


− Insert new lamp in place securely. There is only one possible position due to different size of connecting pins.
− The lamp is pre-focused and does not require any adjustment.
− Reinstall the cover, tighten screws.
− Perform Photometer Calibration.
− Do not touch lamp bulb. If touched accidentally, clean with lint-free cloth or tissue paper and alcohol.

9 Human HumaStar 600 Service Manual


2.5 Pump Tube Replacement

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).

− Pull fittings up and out of bracket.


− Pull tube out of its lodging rotating by hand the pump rotor if necessary.
− Insert new tube on the fittings.
− Install in inverse order.
− Turn slowly rotor by hand until tubing is properly lodged. Once replaced, proceed to reset cycle counter in

Maintenance > Operations > Wear


− Perform Pump Calibration

2.6 Dryer Block Replacement

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.

Once replaced, proceed to reset cycle counter in

Maintenance > Operations > Wear

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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.

Proceed to Maintenance > Operations > Movements

Select in Diluter section, Fix, volume 500 microliters either back or front diluter and press hand or F key.

Once replaced, proceed to reset cycle counter in

Maintenance > Operations > Wear

initialise the system by returning to the main menu and pressing the initialisation button.

2.8 Maintenance of Hydraulic Circuit (service only)

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.

11 Human HumaStar 600 Service Manual


To clean hydraulic system, proceed as follows:

− 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.

If obstruction persists, call Technical Support.


2.9 Photometer and Filter Cleaning (service only)

− Verify that the instrument is turned off and unplugged.


− Remove left side cover.
− Provide adequate external illumination for the following operations.
− Localise photometer and filter wheel.
− Use cotton swabs to remove dirt from filters surface. Rub gently until opalescence is removed.
− NOTICE: Filter No. 0 is an opaque dummy, and requires no cleaning.
− After cleaning is complete, reinstall cover, turn the instrument on and allow it to warm up for 15 minutes.
− Perform a Photometer Calibration. Normally, energy increases by 15% after cleaning.

2.10 ISE Maintenance

Electrode Removal or Cleaning


− Open the small back door in rear panel of instrument with the aid of a screwdriver.
− Remove the fixing screw and flip the hinged ISE module out of the instrument.
− Loosen but do not remove the two fixing hexagonal socket screws as shown in figure 1
− They are located on the backside of ISE module.
− Move the electrodes package to the right so the electrode contacts are free from the connecting clips (Fig 2).
− Pull the electrodes down (Fig 3)
− Silicon rings between electrodes can be washed and re-used
− If necessary remove electrode and clean capillary tubing with cleaning solution. Rinse with distilled water.
− To re-install be sure to preserve the ordering: Cl, K, and Na from top to bottom. Press firmly the whole electrode
− package and re-adjust screws on the back.
− Push the electrode frame to the right so electrode contacts are hold by clips.

12
Fig 1

Fig. 2

Fig. 3

13 Human HumaStar 600 Service Manual


2.11 Pinch Valve Unclogging

− Pull the tubing as indicated by the picture.


− Press corresponding Standard button at the same time.

(Maintenance > Operations > ISE)

− 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.

2.12 Pump Tubing Replacement

− 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:

− Select Maintenance > Operations > ISE


− Press Startup button and wait until calibration is finished.
− Locate the section Electrode conditioning twice.
− Place a cup with serum into the PRIME position.
− Enter into the field Minutes the value 30
− Press Start
− After the condition cycle is finished re-calibrate using the button Calibration.
2.14 Sodium Electrode Conditioning

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.

15 Human HumaStar 600 Service Manual


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3 SECTION III .................................................................................................................................................................................................... 19


3.1 Nomenclature and Naming Conventions............................................................................................................................... 19
3.2 Instrument Architecture................................................................................................................................................................ 20
3.3 Components Detail.......................................................................................................................................................................... 21
3.3.1 Sample and Reagent Trays ......................................................................................................................................................... 21
3.3.2 Probe assemblies front and back ............................................................................................................................................. 21
3.3.3 Reaction trays .................................................................................................................................................................................. 21
3.3.4 Diluters............................................................................................................................................................................................... 21
3.3.5 Photometer ...................................................................................................................................................................................... 21
3.3.6 Automatic Cuvette Washers...................................................................................................................................................... 21
3.4 Device parameters handling........................................................................................................................................................ 22
3.5 Motor controller boards................................................................................................................................................................. 22
3.6 Protocol Overview............................................................................................................................................................................ 25
3.7 Packet Tracking ................................................................................................................................................................................. 25
3.8 C1 Protocol.......................................................................................................................................................................................... 25
3.9 C2 Protocol.......................................................................................................................................................................................... 26
3.10 Protocol layers ................................................................................................................................................................................... 26
3.11 System Tests ...................................................................................................................................................................................... 26
3.11.1 Stray light .......................................................................................................................................................................................... 26
3.11.2 Noise ................................................................................................................................................................................................... 26
3.11.3 Stability .............................................................................................................................................................................................. 27
3.11.4 Washer ............................................................................................................................................................................................... 27
3.11.5 Dilution .............................................................................................................................................................................................. 27
3.11.6 Photometer Linearity.................................................................................................................................................................... 28
3.11.7 Diluter Linearity .............................................................................................................................................................................. 28
3.11.8 Level detection ................................................................................................................................................................................ 28
3.11.9 Diluter accuracy .............................................................................................................................................................................. 28
3.11.10 User operation of System Modules......................................................................................................................................... 29
3.11.11 Operation of manual movements ........................................................................................................................................... 31
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3 SECTION III

3.1 Nomenclature and Naming Conventions

1. Indication to access and identify menus in this manual

− 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).

2. Printed circuit board identification

a) Printed board identification codes (bare board without components)

M 40 X -P218 Instrument code is a two digits number defining


↓ ↓ ↓ original target design for the board (40 means
board originally designed for HumaStar 600).
Instrument Board Board Code
Code Version Next digit indicates board version, digits on the
right of P shows the specific board code.

b) Catalog numbers (ordering code) of boards with components

PL 40 X F 218 Coding is similar to board identification codes


↓ ↓ ↓ ↓ but there is an additional function code which
defines specific components on board.
Instrument Board Function Board
Code Version code Code

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
10
4. Flat wire connections: All flat wire must be connected to match first connector pin to marked wire (red or
black).

19 Human HumaStar 600 Service Manual


Introduction
The HumaStar 600 is a reliable in vitro diagnostic chemistry analyzer for automatic testing of routine clinical
chemistry tests and electrolytes. The instrument is controlled by a PC workstation with graphical user friendly
interface. Software provides total control over the analyzing process and gives easy access to advanced statistical
functions and reports.

3.2 Instrument Architecture

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

Additional devices complete system functions include:


Bar code reader
Sample / Reagent tray
Reagent cooler

INSTRUMENT SCHEMATIC VIEW 1

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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.

3.3.2 Probe assemblies front and back


Probe assembly consists of two stepper motors for vertical and horizontal movements, two optical switches for
sensing home position and verification for each movement working similar to sample tray.
Complete assembly also includes a capacitive level detect circuitry, a probe preheater (for thermostating reagent
0.5 °C above selected reaction chamber temperature), and a collision detector for prevent accidental probe
damage.

3.3.3 Reaction trays


Reaction trays Front and Back consist of a stepper motor, optical switches home and verification sensing.
Each reaction tray is loaded with 80 reaction disposable cuvettes (in strips of five units with 0.6 cm path length).
Max. volume is 700uL.

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.

3.3.6 Automatic Cuvette Washers


There are two washing stations, one for each reaction tray. First pipe aspirates test liquids and delivers washing
solution; next three pipes deliver washing solution and empty cuvettes; and the last one contains a drying block.
Operation of instrument is commanded by two intelligent microcomputers known as concentrators (C1 and C2) to
handle communication packets between computer and instrument devices providing the following services:

Information exchange to specific devices


Parameters storage
Packets tracking / detection of lost packets.
Provision of a standard communication framework

21 Human HumaStar 600 Service Manual


Type Attached intelligent devices
− Diluters
− Temperature controllers
− Preamplifier & photometer motor controller.
C1
− Bar code reader
− ISE controller

− Sample, reagent and reaction trays


− Washers and probes.
C2 − Peristaltic pumps.
− Spare slot functional unit

3.4 Device parameters handling

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.

3.5 Motor controller boards

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.

22
NOTES:

23 Human HumaStar 600 Service Manual


PREAMPLIFIER A PROBE A TEMP CTL PHOTOMETER
DILUTER A
ADDR 0101h ADDR 0114h MOTOR
ADDR 0110h
CONTROLLER
PROBE B TEMP CTL ADDR 0118h
DILUTER B
ADDR 0115h ADDR 0111h
PREAMPLIFIER B
CPU ADDR 0102h
REACT TRAY TMP CTL
ADDR 0116h

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

SPARE A REACTION TRAY B VERTICAL B


PERISTALTIC PUMP A
ADDR=0200h ADDR=0204h ADDR=0208h
ADDR=020Ch
SPARE B WASHER B HORIZONTAL B
PERISTALTIC PUMP B
ADDR=0201h ADDR=0205h ADDR=0209h
ADDR=020Dh

REACTION TRAY A VERTICAL A SAMPLE TRAY


ADDR=0202h ADDR=0206h ADDR=020Ah

WASHER A HORIZONTAL A REACTION TRAY


ADDR=0203h ADDR=0207h ADDR=020Bh

24
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.

Operation data flow

3.7 Packet Tracking

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.

Rule for packet counting

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.

25 Human HumaStar 600 Service Manual


3.9 C2 Protocol

Concentrator 2 uses a TTL interface to handle all the movement-related devices.


After the request transmitted by the C2, an acknowledge packet is returned by the device, then C2 will query the
device at regular times until obtain a valid answer.

Data flow for C2 to FU 1


3.10 Protocol layers

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

To access to system tests, select Maintenance > System tests

3.11.1 Stray light


This test is based in the use of two solutions: one uv sharp blocking and other visible blocking.
Visible blocking is usually Potassium Chromate in high concentration (more than 5 g/l) and should block all light
passing the cuvette. If it fails, light is arriving directly to sensor without travelling through the cuvette.
UV blocking, if visible is passed, indicates actual filter stray light. It is recommended the use of Sodium Nitrite, 50
g/l and reading at 340 nm.
There are two options: either instrument dispenses solutions or user put them directly in the selected cuvettes. Use
“Already dispensed” for selection.
Test is passed if read values are less than 0.1%T.
Volume selection can be used to determine minimum volume that can be safely measured.

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.

26
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

Calibration for cuvette bottom should be performed, prior to other operations.


A liquid pumping level check will be performed by dispensing water with D1 to D4 and measuring the liquid level
with sensor probe (positions 2 to 5). The calculated volume will be recorded for each station (1 to 4).
A liquid suction level check will be performed drawing water with S1 to S5 and measuring the liquid level (if any)
with sensor probe. To be able to measure such small remnant amount, the syringe full loaded with water (500 µL)
will dispense 100 µL in each position (1 to 5). The calculated remnant volume will be recorded for each station
(1 to 5).
A liquid pumping level stability test will be performed dispensing water with D1 to D4, the number of times
determined by the parameter, in different cuvettes (positions 6 to 9, 10 to 13,...) and measuring the liquid level
with sensor probe. The following volumes will be recorded for each station (1 to 4):
individual measurements;
average volume;
standard deviation and variance;
minimum and maximum volumes;
difference between minimum and maximum volumes;
difference between minimum and maximum average volumes of the 4 stations;
relative deviation error of average volumes.
A cuvette wash will be performed in all the used cuvettes.

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%.

27 Human HumaStar 600 Service Manual


3.11.6 Photometer Linearity
This test is intended for evaluation of photometer linearity. To achieve this goal, the test will measure absorbance
(A0 to A4) of 5 different solutions (points 0 to 4) in front and back channels using a specific filter. Each solution will
be prepared by dilution of a stock solution located in a specific on-tray position. For a default initial sample volume
of 8 microliters, system will automatically generate dilutions of 0/300, 8/292, 16/284, etc. maintaining the total
solution volume unchanged.
A cuvette diluent blank will be performed prior to dispensing using a certain volume. Dilution will use the
remaining volume of diluent. After dispensing, a certain time will be observed prior to reading. A certain number of
replicates will be done for each point.
This test differs from 3.11.7 in the range of volumes. For volumes above 8 microliters, it is assumed that diluter
linearity is out of question and any linearity departure is related to electronics or optics.

3.11.7 Diluter Linearity


This test requires a concentrated Potassium Chromate solution (3 g/l in Perchloric 5 mmol/l) and washing solution
as reagents. Given an initial volume (3ul as default) system will generate dilutions using 1, 2, 3, 4 times the initial
volume. Linear correlation and departure from linearity are evaluated. Departures of +/- 5% are accepted.

3.11.8 Level detection


Reagent is taken from a vial located in a fixed position and tip reaches the surface of other reagent located in a
different position. Next, reagent is delivered in the original one. This procedure is sequentially repeated while
volume is varied every cycle within fixed limits. Results and plot will show if level detection is accurate.
Use this test if detection problems are observed with a given method or Brand.

3.11.9 Diluter accuracy


Test determines diluter volume accuracy for low volume measurements.
Sample consists of Potassium Chromate, 3 g/l in acidic medium (Perchloric acid 5 mmol/l) and the reagent is the
same water used for probe and cuvette cleaning (tensioactive added).
Calculation is based on Potassium Chromate extinction coefficient and accuracy of solution preparation.
Accuracy in all cases should be better than 5%.

28
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:

Select range and reaction tray to


wash cuvettes.

Choose dry only when cuvettes


are already clean to enhance
drying.

Turn off washing pumps. To


quiet pumps after a washing
operation.

System flush. to purge both


tubings and syringe.

Tip cleaning. To perform


wash/soak of probe tip.

Photometer tab:

Press buttons to turn on or turn


off the lamp

Motors tab:

Press turn off to de-energise all


motors.

29 Human HumaStar 600 Service Manual


Movements 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:

Displays firmware version and


serial numbers for each device.

Wear tab:

Displays amount of cycles and


last replacement date.

30
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).

Remember when using this mode:


− Initialisation of any device is always required prior its use.
− Washer initialisation is required before reaction tray initialisation.
− Vertical initialisation is required before sample, reagent, reaction tray or horizontal
initialisation.
− Arrow buttons on each module allow single step movement.
− To prevent probe crashes do not use TURN AROUND command as it does not detect
errors.
− For movement and device continuous test use options on stress tab and check errors.log
file for results.

Vertical tab:

Use selector to choose for front or back


arms.

Initialize, moves the vertical to home


position.

Move to position, locates the vertical on


desired number of steps down home.

Find level, moves the probe down looking


for liquid level, slow value, is the position
to start looking for level while moving
slower, bottom value represents the
maximum allowable steps to go down,
and down level value is the amount of
steps to submerse the probe into the
liquid.

31 Human HumaStar 600 Service Manual


Horizontal tab:

Choose front or back arm and then initialize to


move the horizontal to home position, Move to
position, to move the desired number of steps
from home, Move to sample position, to locate
an specific sample number into the specific
sector. (Sector must be already located on the
tray).
Move to reagent, reaction, washing and ISE
position, work similar to previous buttons:

Trays tab:

Choose desired tray and use initialize to move


tray to home, Move to tray position, to advance
a number of steps, and Move to sample
position: for an specific sample number, sector
and arm.

Pumps tab:

Select front or back, for peristaltic pump and


then, initialize, advance or go back.

Tip pump when set to 1, will be on an amount


of time given by the timeout parameter.
Note: set diluter to bypass position before
activation of tip pump.

32
Washing stations:

Choose for front or back wash head, then


initialize, move to position, or move to position
using a second speed for avoid spillage during
drying block cleaning.

Drying pump, when set to 1 turns on the drying


block and the stations 2 3 and 4.

Suction pump, when set to 1 turns on the


reaction suction pump

Temperature tab:

Choose temperature controller then Initialize,


to tranfer internal PID parameters, read temp,
set temp and disable temp to operate
temperature module.

33 Human HumaStar 600 Service Manual


Diluter tab:

Choose front or back, Initialize


And then Move to (steps, speed)

Valve positions:
− bypass is pump to tip
− input is pump to syringe
− output is syringe to probe

BCR tab:

Press Initialize to start operation.


Read, shows result of barcode in front of BCR
device.

Program, sets internal BCR device parameters.

Advanced reading options:


Read sector code (tray position)
Read sample code (sect, pos)
Read reagent code (position)

34
Photometer tab:
development only screen

For single reading, choose desired photometer


and filter.
− - Start conversion and Read to show
current reading.
− - Continuous reading triggers Meas.
readings waiting interval mseg after
each filter wheel turn.

Filter wheel tab:

Start/stop to control filter wheel


Go to filter to start static mode (offset is a
static offset).

Frequency/slope/Pulses per turn/number of


filters/Steps between home and zero load
internal settings to the motor controller board.

Steppers settings tab:


Choose device to configure.
Zero Sensor, Verification: Polarity for sensor, 1
means hole, 0 means solid.(Note: Verif is not
implemented on washer).

Turn Direction: direction for rotation of


movement check that front and back are
usually opposites.

Temp/Voltage control: set to 1 to detect and


produce an error when voltage or temp is out
of range.

Simulated initialization: set to 1 to skip


initialisation (return OK code and produce no
movement).

35 Human HumaStar 600 Service Manual


Step detection disabled: disables verification slit checking.

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.

Level sensor: polarity as collision same usage.

Activate/deactivate: output control according the table below

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

36
Cool tray tab:

Press Read temp. to display current


temperature (it shows zero when cool tray is
off).
Set temperature will set both high and low
trips.

PRESS INSTRUMENT GREEN PUSHBUTTON TO


TURN ON THE COOL TRAY.

Options tab:
Lets the user send a command to the
instrument.

37 Human HumaStar 600 Service Manual


Stress tab:

It moves randomly desired number of


cycles.
Check errors.log file results.

Warning: Do not try to stress both


horizontal and vertical at the same time
as no further checking is performed.

38
C

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
40
4 SECTION IV

4.1 Chart and block diagrams

41 Human HumaStar 600 Service Manual


42
System-layout
43 Human HumaStar 600 Service Manual
Front vertical & horizontal probe movement & preheater
44
Back vertical & horizontal probe movement & preheater
Dual CPU

45 Human HumaStar 600 Service Manual


46
Switching power supplies
Peristaltic pumps

47 Human HumaStar 600 Service Manual


48
Front reaction tray & washer
Back reaction tray & washer

49 Human HumaStar 600 Service Manual


50
Photometer Power on-off control
Reaction chambers heater

51 Human HumaStar 600 Service Manual


52
Blackplane power connection
Sample and reagent trays

53 Human HumaStar 600 Service Manual


54
Pumps distribution board
4.2 Location of belts and sensors

Photometer assembly - top view

Robot assembly overview – side view

55 Human HumaStar 600 Service Manual


Washer assembly – side view

Sample and reagent tray assembly – bottom view

56
Reaction tray– bottom view

57 Human HumaStar 600 Service Manual


4.3 Hydraulics Schematics

Washer hydraulics

Probe hydraulics

58
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

59 Human HumaStar 600 Service Manual


DL1/Red Front tip pump
DL2/Red Back tip pump
DL3/Red Not in use: Front Water pump
DL4/Red Front Drier pump
Pumps distribution board DL5/Red Front Reagent pump
PL400283 DL6/Red Back Reagent pump
DL7/Red Back Drier pump
DL8/Red +12
DL9/Red Not in use: Back Water pump
DL10/Red +24
Cavro XLP6000 Distribution
board DL1/Red +24
PL400284
DL1/Red C2 Development
DL2/Red C2 Development
Dual CPU board DL3/Red C2 Development
PL400285 DL4/Red C1 Development
DL5/Red C1 Development
DL6/Red C1 Development
Heater pwm signal
DL1/Red
Preheater, probe level & Level detect. Single blink on level
DL2/Red
collision detector board detection
DL3/Red
PL400286 Mixer activated
DL4/Red
Collision

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).

− Dual Stepper motor controller PL400242 status leds:


Green led Red 1 led Red 2 led
Normal Mode
− On − Home signal − Collision(washer only)

− Filter wheel motor controller status leds:


Green led Red 1 led Red 2 led
Normal Mode − On − Home signal − Filter signal
Busy − Off − On − On
Verification problem − Blinking − Off − Off
No home detection − Blinking − On − Off

To obtain the program folder press the right button on the HumaStar 600 icon and choose properties.

60
4.5 Computer program folder contents

.Root HumaStar 600 Program folder and Main .exe file


Backup Backup of Data, Historic, Translator and Use data folders
Bin Software parameters, wears, memory backups and about.txt
data Configurations, methods, calibrations, etc.
Historic All historical tables
Interfase Tables shown on screen
Lims Information for laboratory information management system
NSI data Calibration reports and summaries, communication logging, etc.
Priv Used by the database engine
Priv thread Used by the database engine
Reports Tables containing information to build reports
Translator Information for language support
Use data Samples, patients, tests, tray definition.

4.6 Main menu user messages

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

61 Human HumaStar 600 Service Manual


62
C

5 SECTION V: GENERAL TROUBLESHOOTING...................................................................................................................................... 65


5.1 Visible faults....................................................................................................................................................................................... 65
5.1.1 General faults .................................................................................................................................................................................. 65
5.1.2 Automatic cuvette washer malfunctioning......................................................................................................................... 65
5.2 Measurement Inconsistencies .................................................................................................................................................... 66
5.2.1 Consider storage and handling of reagents, standards and controls:....................................................................... 66
5.2.2 All methods ...................................................................................................................................................................................... 66
5.2.3 Colorimetrics with high dispersion ......................................................................................................................................... 66
5.2.4 Colorimetrics with proper dispersion but values too high or low ............................................................................... 66
5.2.5 Kinetics with high dispersion or low linearity..................................................................................................................... 66
5.2.6 Kinetics with normal values too high..................................................................................................................................... 66
5.2.7 Kinetics with normal and pathological values too high.................................................................................................. 67
5.2.8 Kinetics with normal and pathological values too low ................................................................................................... 67
5.2.9 Kinetics with values too low or too high on the whole range....................................................................................... 67
5.2.10 Two point kinetics (high dispersion)....................................................................................................................................... 67
5.2.11 Two point kinetics (high dispersion)....................................................................................................................................... 67
5.2.12 Repetition or dilution (colorimetrics or non linear kinetics) .......................................................................................... 67
5.2.13 Repetition or dilution (two point kinetics) ........................................................................................................................... 67
5.2.14 Reactions (general comparison between reactions) ........................................................................................................ 67
5.3 Verification and diagnostic procedures................................................................................................................................... 68
5.3.1 VD-01: Standard troubleshooting procedure...................................................................................................................... 68
5.3.2 VD-02: Reload instrument parameters being offline....................................................................................................... 68
5.3.3 VD-03: General Voltage checking ............................................................................................................................................ 68
5.3.4 VD-04: Lamp voltage stability checking ................................................................................................................................ 68
5.3.5 VD-05: Photometer calibration check .................................................................................................................................... 69
5.3.6 VD-06: Photometer and lamp alignment check................................................................................................................. 69
5.3.7 VD-07: Instrument general status check .............................................................................................................................. 71
5.3.8 VD-08: Concentrators check ...................................................................................................................................................... 72
5.3.9 VD-09: Probe dispensing pump check.................................................................................................................................... 72
5.3.10 VD-10: Washer hydraulics check.............................................................................................................................................. 72
5.3.11 VD-11: Dispensing hydraulics check....................................................................................................................................... 72
5.3.12 VD-12: Probe robotics check ...................................................................................................................................................... 73
5.3.13 VD-13: Probe level sensing check............................................................................................................................................. 73
5.3.14 VD-14: Tray movement check ................................................................................................................................................... 73
5.3.15 VD-15: Washer mechanical check ........................................................................................................................................... 73
5.3.16 VD-16: Movement test................................................................................................................................................................. 74
5.3.17 VD-17: Diluter belt check ............................................................................................................................................................ 74
5.3.18 VD-18: Temperature controller check.................................................................................................................................... 74

64
5 SECTION V: GENERAL TROUBLESHOOTING

5.1 Visible faults


5.1.1 General faults
Symptom Corrective Action
Drops on probe tip after dispensing Verify hydraulic system in accordance to user’s manual.
Clean probe tip by submerging in Solution 1 for 5
minutes.
Drops on tip after wash cycle. Verify hydraulic system for leaks or obstructions.
Abnormal noises. Defective fans.
Moving parts blocked or frozen.
Temperature in reaction tray is too high. (Do not be Room temperature too high, (should always be at least
concerned about arm probe temperature) 4°C lower than selected working temperature).
Example: For 37°C incubation temperature, Room
temperature should not exceed 33°C.
Temperature in reaction tray is too low. (Do not be Room temperature excessively low. Verify instrument
concerned about arm probe temperature) operating range, and adequate the room temperature.

5.1.2 Automatic cuvette washer malfunctioning

Symptom Corrective Action


At the end of wash cycle, tiny water droplets are in the Verify that all pumps are working.
cuvette walls Verify that no tubing are clogged
Replace drying block
Calibrate washer unit position.
High cross-contamination Identify cross-contaminants and set methods in the
Table of interferences
Increase the wash volume
Increase the number of wash cycles

65 Human HumaStar 600 Service Manual


5.2 Measurement Inconsistencies
5.2.1 Consider storage and handling of reagents, standards and controls:
− Verify expiration date, storage temperatures on and off analyzer.
Check that reagent was not frozen.
− Check color changes, sediments, turbidity, no foam.
− Check not for mixed reagents from different lots nor re-use of reagent bottles.

5.2.2 All methods


− Verify cuvettes for dirt or scratching.
− Remove cuvettes from reaction tray and check volumes for affected cuvettes.
− Verify there are no bubbles or droplet.
− Verify there are no obstructions on probe, check for non constant or regular flow.
− Recalibrate photometer.
− Perform energy, noise and photometric stability tests.

5.2.3 Colorimetrics with high dispersion


− Replace sample by a standard and verify dispersion again, check reaction cuvette-beam alignment.
− Perform hydraulic verification.
− Check for sample centrifugation, increase time and speed.
− Perform energy, noise photometric stability and dilution tests.

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.

5.2.5 Kinetics with high dispersion or low linearity


− Verify if incubation time is too short or heaters are not working properly.
− Verify for abnormally high initial absorbance for decreasing kinetics (problems with reagent preparation)
or too low on increasing kinetics. Replace reagents and compare results.
− Check lamp for stability.
− Use new cuvettes and test again, check cuvettes for dirt or scratching.
− Perform noise and photometric stability, align lamp, clean filters, and check reaction tray-beam
alignment.
− For some kinetics: verify if sample volume is too low.
− For some kinetics: verify centrifugation (increase time and speed).

5.2.6 Kinetics with normal values too high


− Perform energy, noise and photometric stability.
− Perform temperature verification.
− Some kinetics: incorrect factor for selected temperature and volume.

66
− Replace lamp, align lamp, clean filters verify reaction tray positioning.

5.2.7 Kinetics with normal and pathological values too high


− Verify incubation time and temperature. Perform temperature test.
o
− Verify if factor matches selected temperature. Remember selected temperature is usually 37 C.

5.2.8 Kinetics with normal and pathological values too low


− Check for short incubation time or low temperature.
o
− Verify if factor matches selected temperature. Remember selected temperature is usually 37 C.

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.

5.2.10 Two point kinetics (high dispersion)


− Verify if standard absorbance is too low (verify data provided by standard manufacturer).
− Verify initial consumption is too high (verify data provided reagent manufacturer).
− Perform energy tests.
− Verify reagent handling and storage.
− Check method parameter for reagent, low sample volume or too short interval times.
− Check time table for dispersion on first measurement.

5.2.11 Two point kinetics (high dispersion)


− Verify factor, standard and method for reagent.

5.2.12 Repetition or dilution (colorimetrics or non linear kinetics)


− Verify if sample volume is too high, check reagent linear limit.
− Replace reagent and compare.

5.2.13 Repetition or dilution (two point kinetics)


− This is not actually an error; it is because volume / absorbance change relationship is not linear, and so it
is necessary to dilute standard and compare.

5.2.14 Reactions (general comparison between reactions)


− Control quality of water.
− Verify proper usage of solutions (wash solution, rinse solution, etc).
− Use uric acid to check water quality.
− Verify for “frosted” cuvettes (presence of salts).
− Verify scratching or old reactions residues (not enough washing).
− Perform instrument validation tests.

67 Human HumaStar 600 Service Manual


5.3 Verification and diagnostic procedures
5.3.1 VD-01: Standard troubleshooting procedure
Identify symptom
− Obtain a detailed description about the issue from a skilled instrument end user (avoid unspecific
descriptions).
− Ask for any symptom (leaks, noises, beeps, last operations performed before the event)
− Review section III, general troubleshooting to identify additional actions to be performed by user to obtain
extra information.

Recognize variables affecting the result


− Group together symptom or problems to isolate the main cause, consider settings of affected methods
(e.g. results are lower than expected on high controls, instability on methods having low sample volume).
− Use diagnostic tools to isolate the main cause (do not perform resolution steps before identifying main
causes):
− Manual movements window
− Instrument tests
− Information provided in errorslog file.

Fix the cause


− Run fresh controls
− Remove jams, tighten connections
− Repair or replace

Check that solution worked


− Use same tools used before to check resolution of issue.

5.3.2 VD-02: Reload instrument parameters being offline


− Enter to Data > Log as service use as password “pinion”
− Enter to Data > load parameters from the bin folder of HumaStar 600 choose the file memorybackup.ini.

5.3.3 VD-03: General Voltage checking


WARNING:
Reagent cooler power supply is turned on by the green pushbutton.
− Turn on instrument.
− Check if red power push button is blinking (No blink=all power supplies are OK).
− Check the green led located on each power supply.
− In case led is off, test the power supply without load, follow schematic diagrams to find the short circuit.
− Disable power on off board (see schematics).

5.3.4 VD-04: Lamp voltage stability checking


− 1. Check lamp voltage (12v) is steady (±1mV) during instrument operation.
− 2. Check lamp power supply output voltage (Meanwell S-40-12). Check connections, replace PL400273 in
case it introduces the instability.

68
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.

Choose Maintenance > Calibration > Photometer select summarize tab


Proper calibration is defined as:
− -3000 < Zero < 3000
− 20000 < Front, back, and ref channels < 480000
− Highest gain = 16 (for filter #1)
− Ratio is not defined
To clean hydraulic system, proceed as follows:
− 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.
If obstruction persists, call Technical Support.

5.3.6 VD-06: Photometer and lamp alignment check


− Remove preamplifier.
− Turn on instrument.
− Gently block filter wheel movement and rotate manually to choose a bright filter.
− Locate a paper on the preamplifier cavity, check alignment against the reaction tray main rod.

69 Human HumaStar 600 Service Manual


− In case alignment is not ok, check lamp aligning socket.
− Once gross alignment is completed perform lamp alignment optimization (AR-20).
− The optimal adjustment is achieved if the left and center column are at equal level (front & back). The
right column is showing the reference channel.

70
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

System boards status


Id: 0 Ok
Id: 1 Ok
Id: 2 Ok
Id: 3 Ok
Id: 4 Ok
Id: 5 Ok
Id: 6 Ok
Id: 7 Ok
Id: 8 Ok
Id: 9 Ok
Id: 10 Ok
Id: 11 Ok
Id: 12 Ok
Id: 13 Ok

Cooler thermostat: Ok

Concentrator 2: Ok

Waste bottle full


DI water bottle empty
Cover open. Front reaction tray
Cover open. Back reaction tray
Humidity detected on front reaction tray
Humidity detected on back reaction tray
Humidity detected on front horizontal
Humidity detected on back horizontal

71 Human HumaStar 600 Service Manual


5.3.8 VD-08: Concentrators check
− Enter to Data > Log as service > password 31415. then type Maintenance > Service > Manual
− Choose Stress tab, then choose Memory concentrator 1 & 2.
− Set movements to 100, press white hand button to start
− Review results on errors.log file

5.3.9 VD-09: Probe dispensing pump check


− Enter to Maintenance > Operations choose movements tab, set Steps to 500 on pump water section.
− Press A key, check dispensed volume using a burette, specified range is 0.900 to 1.100.
− Check for clogs or identify the faulty pump in case specified range is not meet. (See section II, hydraulics
schematics).

5.3.10 VD-10: Washer hydraulics check


− Choose maintenance > System test > washer hydraulics.
− Dispensed volume should range from 400uL to 700uL depending on method settings.
- When volume is low on all pipes, check/replace peristaltic pump tubing or log as service and check
Maintenance > Service > Parameters > Instrumental parameters Washing station section > front/back
volumes.
- When volume is low on a given pipe, check twisted tubing, clogs, or dirt.
− Aspiration level should range from 0uL to 5uL, when higher than specified on every pipe, check aspiration
pump, when higher than specified on a specific pipe, check for clogs, dirtiness or twisted tubing.

5.3.11 VD-11: Dispensing hydraulics check


Note: 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%
When no potassium chromate is available, test settings can be
modified to use cholesterol reagent and cholesterol standard as
sample.
− Clean or replace water mesh filter (see hydraulic schematics).
− Remove syringe and check syringe glass to plunger contact is tight.
− Perform dilution test (Maintenance > system test > dilution).
− During the test observe the following:
− Check probe tip during operation not for droplets (e.g. dirty probe or damaged Teflon coating).
− Check for air bubbles on defective tubing joints.
− Check for bubbles on syringe plunger edge during aspiration operation (damaged plunger).
− Check / replace probe.
− Check beam alignment on cuvette.
− Check for twisted/clogged tubing.
− If no faulty tubing is identified, externally connect each tubing and repeat the test to identify a faulty
(puncture) tubing.

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.

72
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.

5.3.13 VD-13: Probe level sensing check


1. Perform Level detection test (Maintenance > system tests > Level detection).
2. In case probe stops on air (falsely detecting liquid level),
− Check lab neutral to ground mains below to 1V (both DC and AC modes).
− Check or replace probe.
− Check or replace level sensing board.
− Check or replace wiring from level sensing board to distribution board.

5.3.14 VD-14: Tray movement check


− Reset instrument (press red pushbutton).
− Gently move the tray side to side checking movement is smooth without jams.
− Move the tray from side to side checking controller leds.
− Ensure that neither flag or disc touch optocoupler sensor body.
− Swap front/back motor controllers boards.
− 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.

5.3.15 VD-15: Washer mechanical check


− 1. Reset instrument (press red pushbutton).
− 2. Gently move the wash head up and down to check that movement is smooth without jams.
− 3. Swap controllers.
− 4. Ensure that neither flag or disc touch optocoupler sensor body.
− 5. 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.

73 Human HumaStar 600 Service Manual


5.3.16 VD-16: Movement test
Note: This kind of test will move randomly the selected device with no further checking. Do not
check two conflictive devices simultaneously (e.g. do not test both vertical and horizontal at the
same time).

− 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.

5.3.17 VD-17: Diluter belt check


− Turn off instrument.
− Identify diluter belt.
− Gently rotate belt pulley and use a mirror to check for any belt damage (e.g. cracked belt surface or
missing teeth).

5.3.18 VD-18: Temperature controller check


− Initialize instrument. Enter to Data > Log as service > password 31415 then enter to Maintenance > Service
> Manual select temperature tab.
− Select the temperature control device. Initialize temperature controller and set temp value.
− Press read temperature button.
− In case no value is shown, review errors.log file for further details.

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6 SECTION VI: Adjust and Replacement Procedures .................................................................................................................... 75


6.1 AR-01: Full mechanical calibration............................................................................................................................................ 75
6.2 AR-02: Photometer cleaning........................................................................................................................................................ 79
6.3 AR-03: Probe replacement. ........................................................................................................................................................... 80
6.4 AR-04: Mixer Adjustment ............................................................................................................................................................. 80
6.5 AR-05: Complete removal of reaction tray ............................................................................................................................. 80
6.6 AR-06: Removal of preamplifier.................................................................................................................................................. 80
6.7 AR-07: Removal and replacement of reaction tray heater ............................................................................................... 80
6.8 AR-08: Removal and replacement of reaction tray fan...................................................................................................... 80
6.9 AR-09: Removal of complete probe assembly (vertical & horizontal) ......................................................................... 80
6.10 AR-10: Removal of complete washer........................................................................................................................................ 80
6.11 AR-11: Adjust washer collision sensitivity .............................................................................................................................. 81
6.12 AR-12: Removal of complete reagent cooler assembly ..................................................................................................... 81
6.13 AR-13: Removal of Peltier thermoelectric devices............................................................................................................... 81
6.14 AR-14: Access to reagent verification sensor......................................................................................................................... 81
6.15 AR-15: Reagent tray belt replacement ..................................................................................................................................... 81
6.16 AR-16: Remove Vertical belt......................................................................................................................................................... 81
6.17 AR-17: Remove Horizontal belt................................................................................................................................................... 81
6.18 AR-18: Adjustment of filter delays. ........................................................................................................................................... 82
6.19 AR-19: Photometer calibration ................................................................................................................................................... 82
6.20 AR-20: Lamp alignment optimization ...................................................................................................................................... 82
6 SECTION VI: Adjust and Replacement Procedures

6.1 AR-01: Full mechanical calibration

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.

Arm and Reaction Tray


This calibration will define that tip falls in the reaction tray in the middle of the reaction cuvette. Also, it defines the
cuvette vertical position, which in turn, will define the dispensing height. Calibration includes positioning of
cuvette washer module.
− Select Front Tray; remove cuvette cover and cuvette retainer cover.
− Press F1 function or Start button.
− Use buttons or letters A and D in keyboard until tip is close to the center of cuvettes. Use 10-step or 1-step
option as required.
− Use buttons or letters W and S in keyboard until tip is few millimeters above cuvette.
− Rotate tray by using buttons or letters Q and E in keyboard until cuvette number 1 (labeled with a sticker)
coincides with tip position.
− Repeat steps 3 and 5 until tip falls in the middle of cuvette number 1. For better sensitivity, use 1-step
buttons. Do not fine tune vertical position at this time.
− Press F3 function or Confirm button.
Note:
st
Distance washer to arm = Position of 1 wash station pipe – position of dispensing
22 – 1 = 21 (typical value)
− Confirm washer offset distance (default is 21).
− Loosen washer head screws. Use buttons or letters R and F in keyboard until dryer block reaches cuvette
bottom. Optimum setting is when block spring compresses about 1 mm. Use 10-step or 1-step option as
required.
− Tighten screws.

75 Human HumaStar 600 Service Manual


Press F3 function or Confirm button.
− Shift probe horizontally until tip is above cuvette body but outside cuvette itself.
− Use buttons or letters W and S in keyboard and 1-step mode until tip just touches
upper flat part of cuvette body.
− 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, partial calibrations can be aborted by pressing the Skip button.

Note: Last button does not act on vertical positions. This prevent tip damage.

Arm and Washing Station


In order to improve precise positioning, a double calibration with probe coming form the right and from the left
has been added. Procedure is as follows:
− Select Front Tray.
− Press F1 function or Start button.
− Probe will approach to the washing station from the left. Use buttons or letters A and D in keyboard until
tip is close to the center of washing station. Use 10-step or 1-step option as required.
− Press F5 function or Test button for verification and then F3 function or Confirm button.
− Use buttons or letters W and S in keyboard until tip just touches the bottom of station.
− Press F3 function or Confirm button.
− Press F5 the reaction (Test) function. Probe will go up, go to the reactive position and approach to the
washing station from the right .
− Use buttons or letters A and D in keyboard until tip position coincides with the center.
− Press F5 function or Test button for verification and then 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, partial calibrations can be aborted by pressing the Skip button.

76
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

Arm and Reagent Tray


− Fully remove the reagent cover.
− 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 cap of outer reagent ring. Use
10-step or 1-step option as required.
− Rotate Reagent tray by using buttons or keys Q and E in keyboard.
− Repeat 3 and 4 until tip is in the center of cap of reagent vial number 1.
− Use buttons or letters W and S until tip just touches cap of reagent vial.
− Press F3 function or Confirm button.
− Use buttons or letters A and D in keyboard until tip is close to the center of inner reagent ring. Use 10-step
or 1-step option as required.
− Rotate Reagent tray by using buttons or keys Q and E in keyboard.
− Repeat 3 and 4 until tip is in the center of reagent vial number 25.
− Use buttons or letters W and S until tip just touches cap of reagent vial.
− 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 4 and 9 can be skipped.
Once Start button is pressed, partial calibrations can be aborted by pressing the Skip button.

77 Human HumaStar 600 Service Manual


Sample Tray
This calibration is intended for alignment of sample sectors into the removal
area.
− Press F1 function or Start button.
− Rotate Sample tray by using buttons or keys Q and E in keyboard until
zone 1 is visible in the load area.
− Re-adjust until sector 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.

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.

Bar Code Reader


− Press F1 function or Start button.
− Install in reagent 1 (25) position a vial with valid bar code.
− Use buttons or letters A and D in keyboard until vial is in front of BCR window. Use the 1-step option.
− Press button or key R in keyboard and verify if code is read.
− Repeat steps 3 and 4 until code is read. Look for the central position if code is read in a range of positions.
− Press F3 function or Confirm button.
− Install in sample 1 position a vial with valid bar code.
− Use buttons or letters Q and E in keyboard until vial is in front of BCR window. Use the 1-step option.
− Press button or key R in keyboard and verify if code is read.
− Repeat steps 3 and 4 until code is read. Look for the central position if code is read in a range of positions.
− Press F3 function or Confirm 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.

6.2 AR-02: Photometer cleaning

− Verify that instrument is turned off.


− Remove left side cover.
− Identify photometer and filter wheel.
− Use cotton swabs to remove dirt from filters surface. Rub gently until opalescence is removed.
− After cleaning is complete, reinstall cover, turn the instrument on and allow it to warm up for 15 minutes.
− NOTICE: Filter No. 0 is an opaque dummy, and requires no cleaning.
− Perform a Calibration.

79 Human HumaStar 600 Service Manual


6.3 AR-03: Probe replacement.

− Remove probe assembly plastic cover.


− Disconnect both electrical and hydraulic connections.
− Rotate the probe counter-clockwise to release from main assembly.
− Install the mixer assembly on the new probe and install the new probe.
− Follow the mechanical calibration (AR-01) procedure to adjust: Arm and reaction tray, arm and washing
station, arm and sample, arm and reagent tray and ISE module.
− Perform the Mixer adjustment procedure (AR-04).

6.4 AR-04: Mixer Adjustment

− 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.

6.5 AR-05: Complete removal of reaction tray


− Remove reaction tray cover
− Remove cuvette holder
− Remove the four screws and the plastic reaction tray ring
− Remove the two screws for the cuvette holder lock
− Remove center screw and pull up the reaction tray support
− Remove center screw and pull up the reaction tray support

6.6 AR-06: Removal of preamplifier

− Perform the complete removal of reaction tray (AR-05).


− Remove the preamplifier screw.

6.7 AR-07: Removal and replacement of reaction tray heater

− Perform the complete removal of reaction tray (AR-05).


− Remove the four screws located on heat sink to access to heater

6.8 AR-08: Removal and replacement of reaction tray fan

− Perform the complete removal of reaction tray (AR-05).


− Remove air director from the fans and remove fans.

6.9 AR-09: Removal of complete probe assembly (vertical & horizontal)

− Disconnect J1, J2 and J3 from the distribution board.


− Disconnect the tubing.
− Identify and remove screws on assembly fixture.

6.10 AR-10: Removal of complete washer

− Remove wash head (remove the center screw with spring).


− Disconnect J1 J3 and J5 from distribution board

80
− Identify and remove two screws located on washer fixture.

6.11AR-11: Adjust washer collision sensitivity

− 1. Identify collision sensitivity screw. Rotate clockwise to reduce washer collision sensitivity.

6.12 AR-12: Removal of complete reagent cooler assembly

− Remove sample ring


− Disconnect the tubing from the reagent cooler assembly to the waste bottle.
− Disconnect J3 and J11 from M400P269
− Remove the four screws located on the main structure
− Release the upper setscrew on the plastic rod and pull the pin and then pull up the white plastic rod
− Pull the complete assembly

6.13 AR-13: Removal of Peltier thermoelectric devices

− Remove complete cooler assembly see (AR-12)


− Remove each fan and the four screws. Use a heat gun to heat the metal surface to soften the thermal
grease that glues peltier to the metal cover.

Notes for checking Peltier devices:


As a Peltier device varies its conductivity against the temperature and a current produces an internal temperature
gradient, required instrument for a lab measurement is an AC-O. For field service purposes a DMM is enough to
check it:
− Use a DMM on the lowest resistance range.
− Check not for shorts nor open Peltiers.
− Compare device against others on the cooler assembly
− Measure device in both directions – Check that resistance varies against the time.

6.14 AR-14: Access to reagent verification sensor

− 1. Remove complete cooler assembly, identify home/verification sensor assembly

6.15 AR-15: Reagent tray belt replacement

− Remove complete cooler assembly (AR-12)


− Remove reagent motor
− Remove belt

6.16 AR-16: Remove Vertical belt

− Remove probe assembly (AR-09)


− Identify the vertical belt.
− Remove support screw near to vertical pulley.

6.17 AR-17: Remove Horizontal belt

− Remove probe assembly (AR-09)


− Release motor screws
− Release vertical belt clamp
− Remove complete belt

81 Human HumaStar 600 Service Manual


6.18 AR-18: Adjustment of filter delays.

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.

6.19 AR-19: Photometer calibration

Calibration is performed on four steps:


− During the Initialization, instrument checks communication to the other modules.
− Zero setting, defines the baseline reading level of darkness, it uses filter #13.
− Gain setting, adjusts internal signal levels to ensure linear operation of A/D converter.
− Ratio calculation, establishes the relationship between both front and back sample channels against
reference channel.

− Enter to maintenance > calibration > photometer.


− Check that range for zero is ±3000.
− Choose Sumarize tab and check:
− 2000 < Zero < 2000
− 20000 < Front, back, and ref channels < 480000
− Highest gain = 16 (for filter #1).

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).

6.20 AR-20: Lamp alignment optimization

− 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.

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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.

85 Human HumaStar 600 Service Manual


FBPP. Front & back peristaltic pumps.
FRTW. Front reaction tray and washer.
FVH. Front vertical & horizontal.
FW. Filter Wheel.
Good laboratory practices (GLP). Either general guidelines or formal regulations for performing basic laboratory
operations or activities that are known or believed to influence the quality and integrity of the results.
Goodness-of-fit. the measure of agreement between the data in a data set and the expected or hypothesized
values.
Interference. a positive or negative effect on a measurement caused by a variable other than the one being
investigated.
IR Infrared.
Kinetics Analysis. A kinetics analysis measures the change in concentration of the starting and end products over
time. Usually applied to enzymatic reactions.
Laboratory control standard. A standard, usually certified by an outside agency, used to measure the bias in a
procedure.
Lambert-Beer Law. The Lambert-Beer Law is an equation which describes the linear relationship between the
absorption and the concentration of the absorbing material (absorber). The law states that absorbance (ABS) is
equal to absorptivity a, multiplied by the pathlength or the distance the light travels through the sample b,
multiplied by the concentration c (ABS= abc).
Linearity. In kinetics determinations, the degree of agreement between the measured points and a straight line
assumption.
Mixer. Robotic component that agitates the probe on the cuvette.
Pool (biological). A combination of biological specimens (i.e., urine or serum) from many workers that is used to
prepare small aliquots to be run with each batch of analyses. Aliquots of these pools are analyzed with each batch
of samples and the data are used to develop quality control charts.
Precision. The repeatability or reproducibility of individual measurements expressed as Coefficient of variation
(CV).
Preventative maintenance. An orderly program of activities designed to ensure against equipment failure.
Proficiency testing. Any inter-laboratory testing program where stable specimens are sent to participating
laboratories for analysis. Results from all participating laboratories are compared, pooled, and tabulated by the
testing program operator with the purpose of improving laboratory performance.
Quality assurance program. Written policies and procedures that outline how the laboratory intends to produce
data of known and accepted quality.
Quality Control (QC). The operational techniques and activities that are used to fulfil requirements for quality.
Reagent blank Reagent(s), without analyte or sample added, which are analyzed to determine their contribution to
the total absorbance reading.
Reliability. The likelihood that an instrument or device will function under defined conditions for a specified period
of time.
SRT. Sample & Reagent Tray.
Standard solution. A solution containing a known concentration of analytes, prepared and verified by a prescribed
method or procedure and used routinely in an analytical method.
Standard. Standard samples are aliquots of calibration specimens containing predetermined quantities of the
analyte. The response of each standard, along with the standard's predetermined concentration, is used to
construct a standard calibration curve. From this standard curve, sample concentrations can be computed using
the response from the sample.
Stat. Assay requiring immediate results.
TC. Temperature controller.
Test result. A product obtained from performing a test or assay determination.
UV. Ultraviolet.

86
7.2 General parameters

Notice: Parameters cannot be modified when instrument is in use.

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.

87 Human HumaStar 600 Service Manual


7.3 Technical specifications

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

Stat: Highest priority in operation.


Continuous sample load Data Management:
Windows TM based Software.

Sampling and reagent Interface LIMS: bi-directional RC 232 C, according to


ASTM 1394 requirements.
Samples:
Sample volume: 2 to 100 µL/test (in increments of
1.0µL. Printout: Customer’s optimized (Analysis result,
work list, serums list, Quality Control, Calibration
Sample Tray: 95 (5 racks x 19 positions) ID bar code
curves, etc.)
equipped positions for routine, stat and control
samples and standard solutions.
Primary tube (length up to 100 mm), Power Requirements:

Pediatric vial 110/220V, 50/60 Hz, 2.0 kVA


Dimensions:
97(w) x 67(D) x 100 (H) cm.
Weight:
115 Kg.

88
8 SECTION VIII

8.1 Consumables and Spares

HUMAN Part number QTY Product


Cat.-no
16661/1 CURE2400 1 Reaction cuvettes (box of 1200)
16661/2 M400BS22/30 1 Reagent recipients with cap (x30) vol. 70 ml.
16661/3 M400BS23/30 1 Reagent recipients with cap (x30) vol. 30 ml.
16661/4 M400BH16 1 Peristaltic pump tubing (x3)
16661/5 TUKA2100/100 1 Sample tube φ 13mm (x 100)
16661/6 TUKA2101/100 1 Micro sample tube( x 100)
16661/7 LAR12V20W 1 Halogen lamp 12V 20W
16661/11 M24J14 1 Drying block
16661/12 M400BC02W 1 Probe (Front/Back)
16661/13 VOSB1206 1 Syringe Cavro 734804
16661/14 VO734813 1 Plunger repair kit for VOSB1206
16661/15 ZXM400CS 1 Sample rack

Spare parts for HS 600

HUMAN Part number QTY Product


Cat.-no
FANS
16660/70 OT0FA3V2W4R 1 Reaction tray
16660/71 OT0FA1V2W4 1 Cooled reagent tray
16660/72 OT0FA3V2W4F 1 Cooled reaction tray
16660/73 OT0FA3V2W4R 1 Electronic rack
16660/74 OT0FA4V2W4 1 Rear panel

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.

89 Human HumaStar 600 Service Manual


PUMPS
16660/80 OTSP600EW4 1 Sipper pump
16660/81 OTW01811W4 1 Water delivery pump
16660/82 OTSP700EW4 1 Drying pump
16660/83 OTSPV300W4 1 Pressure ISE
16660/84 M400BH09W 1 Peristaltic Pump Rotor
16660/85 1 Diaphragm for drying pump (repair kit)

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

BOARDS (board number)


16660/100 PL230232W 1 Transient suppressor (M2300-P232)
16660/101 PL240224W 1 Barcode reader interface (M2304-P224)
16660/102 PL400205W 1 Temperature sensor support (M2300-P205)
16660/103 PL400242W 1 SM Controller (M403-P242A)
16660/104 PL40A242W 1 FW Controller (M403-P242B)
16660/105 PL400244W 1 PRE (M402-P244)
16660/106 PL400245W 1 Backplane (M402-P245)
16660/107 PL401246W 1 Temperature Controller (M401-P246)
16660/108 PL400247W 1 CPU (M402-P247)
16660/109 PL400248W 1 Pre dist board (M401-P248)
16660/110 PL400253W 1 Heater power control (M401-P253)

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

91 Human HumaStar 600 Service Manual


92
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

02/2008-04

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