Beruflich Dokumente
Kultur Dokumente
5. ELECTRONICS ................................................................................... 45
5.1. SWITCHING POWER SUPPLY ........................................................................................... 45
5.2. CENTRAL COMMAND UNIT, CCU BOARD ....................................................................... 45
5.2.1. Function ............................................................................................................................ 45
5.2.2. Functional Schematic ........................................................................................................ 46
5.2.3. Components Layout .......................................................................................................... 47
5.3. CENTRAL PROCESSING UNIT: CPU BOARD ..................................................................... 50
5.4. LIQUID SENSOR ADJ. /CONNECTION DISTRIBUTION BOARD ......................................... 51
5.5. LCD ADAPTOR BOARD .................................................................................................... 53
5.6. ON BOARD THERMAL PRINTER DRIVER BOARD ............................................................. 53
6. MECHANICS ..................................................................................... 55
6.1. SAMPLE PROBE ARM ...................................................................................................... 55
6.2. DILUTION MACHINE ASSEMBLY ..................................................................................... 56
6.3. VACUUM PUMP MACHINE ............................................................................................. 58
7. SERVICE SOFTWARE.......................................................................... 59
7.1. MECHANICS .................................................................................................................... 59
7.1.1. Electronic Valve ................................................................................................................ 60
7.1.2. Motor ................................................................................................................................ 60
7.1.3. Circuit ................................................................................................................................ 61
7.1.4. Interface............................................................................................................................ 62
7.2. SPECIAL ........................................................................................................................... 62
7.2.1. Factory mode .................................................................................................................... 62
7.2.2. Parameters screen ............................................................................................................ 62
7.3. NETWORK TRANSFERT PROTOCOL ................................................................................. 64
7.3.1. Introduction ...................................................................................................................... 64
7.3.2. Transfer protocol .............................................................................................................. 64
7.3.3. Wiring ............................................................................................................................... 64
7.3.4. Data block format ............................................................................................................. 64
7.3.5. Usage of WBC, RBC, PLT histogram data .......................................................................... 65
7.3.6. Example ............................................................................................................................ 65
7.3.7. Hardware to test communication ..................................................................................... 67
9. MAINTENANCE ................................................................................. 79
9.1. USER MAINTENANCE ...................................................................................................... 79
9.1.1. Daily maintenance ............................................................................................................ 79
9.1.2. Weekly maintenance ........................................................................................................ 79
9.1.3. On demand maintenance ................................................................................................. 79
9.1.4. Maintenance log ............................................................................................................... 79
9.2. SFRI TECHNICAL MAINTENANCE .................................................................................... 80
9.3. PREVENTIVE MAINTENANCE PROCEDURE ..................................................................... 80
9.3.1. Spare parts, TOOLS and disposable .................................................................................. 80
9.3.2. Procedure ......................................................................................................................... 80
List of appendices
Appendix 1 Safety Symbols ................................................................................................................ 111
Appendix 2 Reagents and Consummables list.................................................................................... 113
Appendix 3 Installation Check List ...................................................................................................... 115
Appendix 4 Preventive Maintenance Check List ................................................................................ 117
Appendix 5 Spare Part List.................................................................................................................. 121
Appendix 6 Preventive Maintenance Kit Content .............................................................................. 123
SFRI Sarl owns all rights to this unpublished work and intends to maintain this work as confidential.
SFRI Sarl may also seek to maintain this work as an unpublished copyright. This publication is to be
used solely for the purposes of reference, operation, maintenance, or repair of SFRI Sarl equipment.
No part of this can be disseminated for other purposes.
In the event of inadvertent or deliberate publication, SFRI Sarl intends to enforce its rights to this work
under copyright laws as a published work. Those having access to this work may not copy, use, or
disclose the information in this work unless expressly authorized by SFRI Sarl to do so.
All information contained in this publication is believed to be correct. SFRI Sarl shall not be liable for
errors contained herein nor for incidental or consequential damages in connection with the furnishing,
performance, or use of this material. This publication may refer to information and protected by
copyrights or patents and does not convey any license under the patent rights of SFRI Sarl, nor the
rights of others. SFRI Sarl does not assume any liability arising out of any infringements of patents or
other rights of third parties.
Warning
For continued safe use of this equipment, it is necessary that the listed instructions are followed.
However, instructions listed in this manual in no way supersede established medical practices
concerning patient care.
This equipment is intended for use only by medical professionals in health care institutions.
To avoid electrical shock, you should not open any cover by yourself. Service must be carried
out by qualified personnel only.
It is dangerous to expose electrical contact or applicant coupler to normal saline, other liquid
or conductive adhesive. Electrical contact and coupler such as cable connector, power supply
must be kept clean and dry. Once being polluted by liquid, they must be thoroughly dried. If
to further remove the pollution, please contact your biomedical department or SFRI Sarl.
It is important for the hospital or organization that employs this equipment to carry out a reasonable
maintenance schedule. Neglect of this may result in machine breakdown or injury of human health.
Upon request, SFRI Sarl may provide, with compensation, necessary circuit diagrams, calibration
illustration list and other information to help qualified technician to maintain and repair some parts,
which SFRI Sarl may define as user serviceable.
Exemptions
SFRI Sarl's obligation or liability under this warranty does not include any transportation or other
charges or liability for direct, indirect or consequential damages or delay resulting from the improper
use or application of the product or the substitution upon it of parts or accessories not approved by
SFRI Sarl or repaired by anyone other than a SFRI Sarl authorized representative.
This warranty shall not extend to any instrument which has been subjected to misuse, negligence or
accident; any instrument from which SFRI Sarl's original serial number tag or product identification
markings have been altered or removed, or any product of any other manufacturer.
Warning
The HEMIX 3-30 is an In Vitro Diagnostic instrument. It may indirectly bring risks to patients and
present a direct risk to operators and the environment during manipulation. To avoid these risks, be
sure to read the following instructions carefully.
This device uses AC 220V alternating courant. Do not open the rear cover before switching
off the power supply. If you need to open the rear cover of the device for maintenance
reasons, please contact our service personnel or professionals.
Patient samples are potentially contaminating agents. Manipulate with care using
appropriate protection equipment (glasses, gloves and laboratory coat) and be sure to
dispose of the waste in accordance with relevant regulations of your hospital.
Do not operate the device unless you have read this Operation Manual carefully
Class
According to anti-electric shock: Grade II, Pollution 2
According to defend deleterious liquid: General Equipment (Closed Equipment)
According to disinfection method: Recommend by manufactory
According to safety degree: Do not use the equipment under the environment of mixed with
flammable air or the air is mixed with O2 and NO
According to working state: Continuous running Equipment
Règlementation
DIV 98/79
Screen
Status
LED
Thermal
Printer Sample
Door Needle
Start
Key
Picture 1-1
11
1
12
2
13
3 14
4 15
16
5
17
6
18
7
19
8
9 10 Picture 1-2
# Description
1 Parallel Printer Port
2 PS2 Mouse Port
3 PS2 Keyboard Port
4 Equipotential Connector
5 Power Switch
6 Lyse Inlet Tube Connector
7 Waste Full Sensor Connector
8 Waste Outlet
9 Cleaner Inlet Tube Connector
10 Diluent Inlet Tube Connector
11 Cooling Fan (Expulses air)
12 USB Port 1
13 USB Port 2
14 VGA Port
15 RS232 Port, COM 1
16 RS232 Port COM 2
17 Cooling Fan (Aspirates air, with air filter)
18 Power Socket with Fuses Housing
19 Switching Power Supply Cooling Fan
Table 1-1
Mark Designation
1 Vacuum pump assembly
2 Dilution block assembly
3 Counting chamber
4 Three valves support assembly
5 Five valves support assembly
6 One valve support assembly
7 Mechanical assembly
8 Two valves support assembly
Table 1-2
ITEMS UNITS
WBC 109 / L
RBC 1012 / L
MCV fL
HGB G/L
PLT 109 / L
MPV fL
Table 1-4
ITEMS UNITS
LYM% %
MON% %
GRAN% %
RDW-SD fL
RDW-CV %
PDW %
P-LCR %
Table 1-5
ITEMS UNITS
LYM# 109 / L
MON# 109 / L
GRAN# 109 / L
HCT %
MCH pg
MCHC g/L
PCT %
Table 1-6
1.4.3. DILUTION
1.4.4. INPUT/OUTPUT
Display Language
8” LCD screen English, French, Spanish
High resolution: 640x480 mm (Software not multilingual, dedicated
Color display Disc On Module requested)
HEMIX 3-30 measures 330(W) x 430(H) x 380(D) mm. There should be adequate space for the
instrument as well as the mouse, keyboard, external printer (optional), external barcode reader
(optional). Make sure that there is at least 15 cm of clearance around the top, sides and back of the
instrument. Ensure that there is adequate space for reagents either under the counter or at counter
level. Instrument weight is 17,5 kg. Make sure you will enough space to perform annual preventive
maintenance or on demand repair.
The HEMIX 3-30 should be located in a controlled environment free from dust, mechanical vibrations,
loud noises and electrical / magnetic interferences. Avoid proximity to brush type motors, flickering
fluorescent lights and electrical contacts that regularly open and close. Avoid placing the instrument
in direct sunlight or in front of a source of heat or drafts. The instrument should be kept in a
temperature controlled environment between 18°C to 35°C (65°F to 95°F) with humidity between 10%
to 90% non-condensing.
HEMIX 3-30 requires a properly grounded outlet supplying 100 – 264 Va.c., 47 to 63 Hz. Power
consumption is 150 VA max.
We recommend the use of a 300 VA UPS.
Humidity should be less than 70%
Atmospheric pressure has to be between 86.0 and 106 kPa.
NOTE: theft or damage to the HEMIX 3-30 and related systems is not responsibility of SFRI France. It
is responsibility of the consignee to fill all claims with the freight carrier and to make sure that all
shipments are properly insured.
Picture 2-1
h) Take out the tie wrap blocking the sample arm like shown in the photograph bellow
i) Take out the tape covering the counting chamber, making sure you are not living any
piece of tape.
Push gently the vertical guidance system to the left,
Remove the tape.
j) Remove the fluidic ports protectors in the back side of the unit
k) Connect the reagents supply tubes in the inlet fluidic ports (rear panel).
We call background a measurement done without aspirating any blood, but air. In order to avoid
registering the results of background tests in the DATALOG, you may enter 999999 code in patient Id.
Press the Start Key without presenting any tube to the sample probe and let the instrument perform
a complete counting cycle. The results given by the unit should comply with the following table:
Item Range
WBC 0.0 – 0.2 x 109/L
RBC 0.00 – 0.02 x 106/µL
PLT 0 – 6 x 103/µL
HCT 0.0 – 0.5 %
Table 2-1
Should the Background results be out of tolerances, please refer to Trouble shooting section.
2.4.2. STABILITY : CV
Once the system is able to perform at least five backgrounds in range you can go through the stability
verification.
Run 15 replicates of a normal level SFRI blood control in factory mode (Refer to Software Chapter) and
make the instrument calculate for you the CV.
If the CV values are in range (see table 2-2 below), then see if they are in target, ie, if the results comply
with the control target. If they match, the system is ready to be used. If they are not you have to
perform a calibration.
IMPORTANT NOTE:
HEMIX 3-30 System has two sets of calibration factors:
One set is the factory one, and can be seen and adjusted in “Factory” mode of the software.
The second set is the user one, and can be adjusted manually or automatically by the user, in
“Normal” software mode.
If your system is stable and the values are not in range, you may need to calibrate the unit. Use only
SFRI Calibration Blood, and follow the calibration procedure as described in Operator Manual version
HEMIX-3/30_Operator Manual_ENG_V14.00 or above.
The Coulter principle states that particles pulled through an orifice, concurrent with an electric current,
produce a change in impedance that is proportional to the volume of the particle traversing the orifice.
This pulse in impedance originates from the displacement of electrolyte caused by the particle. The
Coulter principle was named for its inventor, Wallace H. Coulter when he was working for the
Department of Naval Research to standardize the size of solid particles in the paint used on US
battleships in order to improve its adherence to the hull. The principle has found commercial success
in the medical industry, in particular in hematology, where it can be applied to count and size the
various cells that make up whole blood.
Cells, being non-conducting particles, alter the effective cross-section of the conductive micro channel.
If these particles are non-conducting, the electrical resistance across the channel increases, causing
the electric current passing across the channel to briefly decrease. By monitoring such pulses in electric
current, the number of particles for a given volume of fluid can be counted. The size of the electric
current change is related to the size of the particle, enabling a particle size distribution to be measured,
which can be correlated to mobility, surface charge, and concentration of the particles.
Picture 3-1
The Coulter principal basically deals with the well known Ohm low:
U=RxI
Where U is the voltage, R the resistance and I the current.
A constant current generator is applied to the electrodes of two chambers separated by an orifice,
filled with electrolyte (diluent). This current generates a base line voltage whose value changes while
blood cells are crossing the orifice.
As a result, the measured voltage is a direct function of the size of the cells crossing the apertures.
U = f(ps)
Where U is the voltage and ps the particule size.
THREASHOLDS
Each cell crossing the apertures will create a signal, a voltage pulse, which amplitude will be compared
to triggers, allowing their classification on WBC, RBC and PLT. These thresholds are software values
that are inside the executable program. Neither the user nor the service people are able and allowed
to modify these values.
HISTOGRAMS
Each pulse will be analyzed and stored to a specific memory area, depending on its characteristics.
Once the counting time is over (after 12 seconds), the memorized data is processed and the histograms
are performed. It is then possible to get any histogram derived data.
Picture 3-2
After initialization and between each sample counting, the unit is in standby mode.
All the reagents are primed and the chambers are filled with diluent.
Vacuum / Pressure chamber is at atmospheric pressure.
The constant current generator is off.
Burn voltage is off.
Dilution mechanism and vacuum /pressure mechanism are at home position while sample probe arm
is positioned ready to pipette a new sample blood.
All valves are off (i.e., not energized). Two ways valves are closed, and three ways valves are in NO
(Normally Opened) position.
HGB lamp is on.
Motors power is off.
4.1.2. DILUTION
The blood tube is presented to the sample probe, start switch is pushed, 9,6 µL of sample is aspirated.
A first dilution is done in the counting chamber. Dilution ratio is 1/300 in venous and capillary mode.
A little amount of volume is then aspirated to prepare the second dilution in the counting chamber:
Dilution ratio will be 1/44600. Lyse is dispensed to counting chamber: 460 µL. HGB is read by the
spectrophotometer. The RBC / PLT dilution will be done after WBC count and chamber cleaning. Air
bubble are sent by the underneath of the chamber in order to mix properly the dilution.
4.1.3. COUNTING
As soon as the first dilution is ready in the chamber, the vacuum/pressure pump generates an accurate
and stable counting vacuum. The cells are then hydro-focused in a fluidic current in order to be counted
during 12 seconds. At this step, only the WBC are counted.
The chamber is then emptied and cleaned in order to have the second dilution prepared. Using the
first dilution volume present in the needle together with additional diluent, the dilution is performed,
mixed, and the PLT and RBC are then counted during 12 seconds.
The software is controlling the consistency of cells circulation in order to detect any fluidics problem.
CAUTION: Vacuum value is not controlled by the system. It is important to run every morning a
quality control blood to make sure this function is performed properly.
In principal if the preventive maintenance is done according to SFRI recommendation, the vacuum
should be operating properly between at least two preventive maintenance visits. Should you suspect
any counting vacuum problem please use an external manometer to make sure this function is
complying with the specs.
Once the counting is finished, the chamber is emptied (to external waste), the counting line is cleaned
with cleaner primed by the vacuum pump. The chamber is cleaned internally with diluent and finally
filled again with diluent, in order to get back to standby mode. In the meantime the probe has been
cleaned internally as well with diluent.
2.4*4.2mm*PVC+Straight 35+Straight
G8 V7-NC steel tube-2
Through Tube+1.6*3.5mm*PVC Through Tube+380
2.4*4.2mm*PVC+Straight 35+Straight
G22 V5-C steel tube‐2
Through Tube+1.6*3.5mm*PVC Through Tube+75
1.6*3.5mm*PVC+1.75*2.45mm*Teflon+1.6
G27 Chamber-3 40+80+40 Tee-tube
*3.5mm*PVC
G28 Tee-tube 1.6*3.5mm*PVC 35 steel tube-2
Table 4-1
FUNCTION:
Two dilutions are performed in this chamber to allow blood cells counting.
A first dilution with 9,6 µL of whole blood pipetted by the sample needle directly from the patient tube
will be used to read HGB and count WBC. Before dispensing the Lyse, some volume of this first dilution
will be aspirated and maintained in the needle for a second dilution.
Once the counting is finished, the chamber is cleaned, and emptied, and the second dilution to count
RBC and PLT is done.
The aperture of this chamber has an 80 µm orifice and the aperture voltage range is between 13 Vdc
and 23 Vdc. The ruby separates two areas of the chamber; in each of them an electrode is located,
driving either the counting controlled constant current or the “high AC voltage”, in charge of the
burning function coming from the CCU board.
The electrodes of the chamber are connected to the CCU Board at J15
Picture 4-3: Dilution block (Global view) Picture 4-4: Dilution block (Exploded view)
FUNCTION:
The function of this assembly is to prime and aspirate / dispense reagents, sample blood (sample,
control, and calibrator). It is composed of a single Teflon block, in which 3 chambers and their
corresponding pistons are in charge to deliver accurate volumes of blood, diluent and lyse.
The three pistons are mechanically linked and thus are moving at the same time. The valves activation
program allows proper volumes delivery as required.
IMPORTANT: the sample piston has a specific design, making possible to control the other two pistons
without any consequence on the sample one. Two mechanical stops, located at specific position allow
this to be possible. Refer to picture 4-8 below (mark 2).
NEVER TOUCH THE TWO STOP NUTS, THEIR POSITION IS FACTORY ADJUSTED
AND NEVER HAVE TO BE CHANGED.
CAUTION: the part 4 shown in picture 4-8, is a precision Teflon guide. Please handle with care while
performing maintenance on the Dilution Block.
FUNCTION:
Counting vacuum: provides accurate and stable vacuum for the counting phase
Mixing: Provide positive pressure to send air bubbles to the chambers, mixing function
Priming the cleaner during cleaning phase
Waste the vacuum pump contain
Picture 4-7: Vacuum block assembly (Global view) Picture 4-8: Vacuum block assembly (Exploded view)
FUNCTION:
Wash the external part of the sample probe after blood aspiration
Picture 4-10: Local exploded view of the sample probe washer assembly
ITEM CODE: S020007-02 (Two ways valve) ITEM CODE: S020008-02 (Three ways valve)
Picture 4-12 Picture 4-13
FUNCTION:
FUNCTION :
Provide +12Vdc and +5Vdc to CPU board (via CCU, and jumper JP4) and CCU board
+5Vdc / 4A is intended to power the CPU board
+12 Vdc is intended to power the CCU board
Provide +5Vdc and +12Vdc to
NOTE:
An internal trimmer allows the adjustment of these voltages, paying attention that the CPU
voltage mustn’t be lower than 4,5 Vdc
Two fuses of 3,15A (delayed)
5.2.1. FUNCTION
5.2.1.1. ACTUATORS
Motors driver
o Motor A (1): Sample probe vertical movement
o Motor B (2): Sample probe horizontal movement
o Motor C (3): Dilution block movement
o Motor D (4): Vacuum / Pressure pump
2 way valves
3 way valves
Constant current generator (coulter principal cells counting)
High AC voltage for “burn” function
5.2.1.2. SENSORS
HEMIX 3-30
Switching CCU Board
Power To PC 104
Supply CPU
From
Vacuum Motor Home
Block D Sensor
Aquisition Counting
RBC A/D
Driver D
Conv
Chamber
Micro
contr
olle
Diluent t°
T° sensor Sensor Filtering
Aquisition
Internal
On board Printer WBC A/D
Thermal Driver Micro Conv
Printer contr erter
olle
Burn Constant
From Burn
Voltage Current
Transformer
Controller Generat
110 Vac
or
To Counting
Chamber
Diagram Block
Picture 5-1
Picture 5-4
FUNCTION :
This is the HID of the instrument. This industrial computer provides all basic input and output system
for the user, and communication with machine level software, ie, communication with the CCU
firmware through a PC104 bus.
A compact flash memory, or a Disc On Module, connected to the CPU, contains all BIOS, OS and
application software, allowing the unit to operate. The picture below shows all the connectors detail.
FUNCTION :
This board interfaces the connections between the CCU board and the actuators and sensors.
⑨ ⑩
① ② ③
④ ⑤
Picture 5-6
FUNCTION:
The main function of LCD Adaptor Board is to connect the screen to the CPU with cable. It interfaces
TFT through FPC soft cable.
Picture 5-7
Picture 5-8
Picture 6-1
Two movements are carried out to perform these positioning: vertical and horizontal.
Thus, two stepper motors are involved, Motor A (vertical movement), and Motor B (horizontal
movement). Each movement has a home position, controlled by an optical sensor.
FUNCTION:
The rotational movement of the stepper motor is transformed in a linear vertical movement by a gear
and a rod. An optical sensor stops the mechanics in its home position.
The rod drives vertically a bracket that maintains the three pistons of the dilution block together. As a
results all the pistons but the sample one are moving together. The sample piston has a particular
design that allows the piston to remain in place while the others are moving.
The bearings bracket and the pulley are helping the vertical movement to be done smoothly.
FUNCTION:
The rotational movement of the stepper motor is transformed in a linear vertical movement by a gear
and a rod. An optical sensor stops the mechanics in its home position.
Picture 6-5
7.1. Mechanics
This Service Program allows the service engineer to troubleshoot, by checking actuators and sensors.
This program sends single commands to the CCU.
Picture 7-1
Picture 7-2
Here we can activate each valve for a couple of seconds by clicking on its “T” command.
Doing so, you have to hear the commutation sound, which is louder for the two-way valves.
NOTE: Valves 1, is not used. The “T” command is grey, and a click on it has no effect.
7.1.2. MOTOR
A click on “T” command of each motor will generate a movement to get the mechanical part to home
position. If the mechanism is already at home position, the firmware will move the flag out and in
again. If the mechanism is out of home position, the firmware will move the flag toward home position.
If the system does not detect any error on the movement the software will send an “Ok” status,
otherwise “Failed” will be prompted.
Motor A: Vertical Movement of the Sample Probe Arm
Motor B: Horizontal Movement of the Sample Probe Arm
Motor C: Dilution Block Movement
Motor D: Vacuum Pump Movement
This part of the Mechanic software is dedicated to test the CCU board
WBC AD / RBC AD / PLT AD: test of the Analogical to Digital converters for each channel. There are
three converters, one by cell type. The system sends a value to convert and the software tests the
feedback. The system returns “OK” if the returned value is the good one and “Failed” if not.
This function allows to test the interruptions control between main micro-controller of the CCU and
the dedicated 3 micro-controllers in charge of the cell pulses acquisition (WBC, RBC, PLT pulses).
7.1.3.3. 5V POWER
7.1.3.4. HGB
This function returns the actual HGB sensor reading. Please refer to Adjustments and Controls chapter
for more details.
7.1.3.5. VACUUM
This function creates a specific vacuum value (counting vacuum). Activating this command will make
the vacuum piston move up to predefined specific position.
7.1.3.6. DC POWER
This is the “Enable” signal sent by the software to the CCU board.
7.1.3.7. CC POWER
This function allows you to test the Constant Current generator. A click on its “T” command will activate
relay K3, as a result the Constant Current will be sent to the electrodes of the counting chamber in
order to generate the base line voltage.
7.1.3.8. BURN
This function sends 110 Vac directly to the electrodes of the counting chamber in order to clean the
aperture and prevent clogs that could appear due to orifice diameter reduction while proteins get
agglutinated. Relay K4 is activated to send this “high” AC voltage to the chamber.
7.1.3.9. R. TEMP
This function returns the actual diluents’ temperature, measured by the sensor integrated in the
sample line.
7.1.3.10. SPEAKER
This function is returning the aperture voltage value while clicking on “T1”.
The system will generate a vacuum, open the counting valve V5, and send the constant current to the
electrodes in order to generate the base line voltage. The current aperture voltage will be displayed
after a couple of seconds.
Then the system goes back to stand by, ie, stops the constant current and the diluent circulation. The
measured value remains in the screen.
An action on the T2 command will refresh the actual baseline voltage value that has to drop below 3
Vdc. Typical value is around 1,5 Vdc.
7.1.4. INTERFACE
7.2. Special
7.2.1. FACTORY MODE
NOTE: In factory mode, the apertures voltages are displayed in the left bottom area of the screen, in
red. This functionality allows you to check if the aperture voltages are stable and in range.
Pressing F12 will switch from normal to factory mode unless you enter again 6666 password as
explained above, or instrument is powered off.
IMPORTANT NOTE: never leave the unit with factory mode accessible for the end user.
All the standard functions of the unit are the same than in user mode.
You should print and save these parameters before sending the unit at customer site
Access to this screen: Service -> Special -> Enter password 6868
Picture 7-3
7.2.2.1. PARA
Do not attempt to adjust these parameters, they are factory set and do not need any adjustment in
the field, unless SFRI authorized specialist indicates you to perform changes there.
7.2.2.2. FLUIDICS
WBC & RBC Time (s): Software fixed at 12 seconds. This value must not be changed.
WBC & RBC Hole: These are the reference values that the system uses in order to return a clog
situation. Refer to adjustment chapter for procedure.
WBC & RBC threshold: Factory values that do not have to be changed.
Temp. Low: sets the minimum room temperature allowed to the system to work.
Temp High: sets the maximum room temperature allowed to the system to work.
Motor A, B, C and D: motor steps for mechanics positioning. Factory adjusted, they do not have to be
modified.
SFRI HEMIX3-30 hematology analyzer uses RS-232 port as a network transmission. There are
three data lines on transmission: TxD, RxD, GND. The data transfer to the receiving device by
a one-way transmission, not response of data request for any external device. This protocol
adopts characteristic identification method and data block on transmission. All the decimal
points could not be transferred in practice.
7.3.3. WIRING
Picture 7-4
The total number of the received data between (0,255) is 256. If there are 256 points on the
X-axis of the histogram, set the proportion of Y-coordinates as “a”. Divide the 256 received
data respectively by “a”, the results as the values of Y-coordinates. Draw the corresponding X-
coordinates in the received order.
7.3.6. EXAMPLE
@a05060300820050603214308069#269#121#610#019#008#042#420#095#361#0860#0226#0263#
465#150#117#097#113#011#141####################################0200570822550101640
Use Hyper Terminal or HTerm and a female / female DB9 crossed RS232 cable, using only RxD, TxD
and GND.
The related data of the transfer is shown in the following result printout
Picture 7-6
After each Preventive Maintenance, or as required during troubleshooting, error or warning messages,
some controls and / or adjustments may be performed. You will read bellow the detailed explanation
/ procedure for each adjustment and control.
Picture 8-1
In this screen you can allow automatic printing, set the Sleep time and set the clean period.
You can also decide to print or not the limits.
At this time, it should issue a crisp Di Di sound, Waste Full alarm will be displayed in the right bottom
area of the screen.
When the system runs out of reagent, Diluent Empty, Lyse Empty and Cleaner Empty alarm
information will be displayed in the error message area of the screen.
Unplug the waste liquid short circuit connector on the back board of the HEMIX3-30, power off and
on. The instrument should be able to start, without any warning message.
Clicking on T button makes the corresponding valve commutate, remaining open for a couple of
seconds. You must hear the mechanical sound of commutation, taking in account that two way valves
have a louder sound than the 3 way valves.
The analogical to digital converter is automatically checked by activating the T command of each A/D
converter (WBC, RBC and PLT). The software sends a command with data to convert and collects the
expected result. The status screen will display OK or FAILED.
8.4.2. INT
The Interruption Controller is responsible for the cells signals acquisition. To check the interruptions
request click T command of each channel, each microcontroller. The status screen will return OK or
FAILED.
NOTE: turning VR5 clockwise decreases HGB value / counterclockwise increases HGB value.
IMPORTANT: you have to make sure before adjusting that the chamber is clean and filled with diluent,
properly primed.
IMPORTANT: two error messages are related to the HGB, depending on the blank voltage value read
during the test.
iii. In the same fitting of the vacuum pump, connect the vacuum meter tubing, as shown I
photograph 8-4
Picture 8-4
You have to read negative pressure around 250 mbar +/- 10 mbar.
Decrease of this vacuum have to be less than 2 mbar per 2 minutes.
vi. Click again on T button of Vacuum function. The piston will go down to home position.
vii. Disconnect the manometer tubing, and put in place the original tubing.
Open the right panel of the unit by unscrewing the two Allen screws (2.5 mm), you can access
to the fluidics panel
Set voltmeter to Vac
Introduce the red probe of the voltmeter inside the WBC/RBC chamber and apply the black
probe to ground,
Click on T button of Burning function
You should read a value around 90 Vac (the relay remains switched a very short time, so the
reading of the target value is furtive).
NOTE: HEMIX 3-30 has been designed to work between 18°C and 35°C.
Make sure the room temperature where the unit is located complies with this requirement.
Clicking T2 command will switch off the constant current to the electrodes. At that moment the
residual voltage displayed have to be less than 3 Vdc for both chambers.
Click “Service”—“Special”, in the pop-up message box input password: “6666”, click OK, press F12 on
the keyboard, to make the host enter into “Factory” mode “the system interface above should display
“factory”
Under the venous mode, run 5 backgrounds, blank test (press start switch without presenting any
sample). Each background result should be in specs. If the blank tests are out of tolerances, cleaning
or strong cleaning procedure may be required, as well as burn function.
After each blank test, press F5, F6 and F7 in order to monitor the pulse graph and data amount for
WBC channel, RBC channel and PLT channel, the pulse graph of each channel should have no disturb
noise “the good pulse picture should smooth ”, the data amount should meet the requirement below.
WBC ≤200KB (Displayed 200 000)
RBC ≤100KB
PLT ≤300KB
Record the W.H.V.S. and R.H.V.S. after each test, calculate the average of 5 times W.H.V.S. and
R.H.V.S., and input into the Parameters (click Service----Special, in the pop-up message box input WBC
Hole and RBC Hole under password 6868)
Picture 8-6
The function of the retaining ring shown in the picture bellow is to ensure the good positioning of the
sample probe if ever you have to take off the probe from the system for maintenance.
Picture 8-7
1. YOU WANT TO TAKE OUT THE RETAINING RING FOR THE MAINTENANCE OF THE SAMPLE
PROBE :
For the reassembly, you need to find the exact position of the sample probe, using the adjustment
tool below, and following the instructions.
a) To take out the sample probe, you need to loosen the retaining ring,
b) Position the sample probe and the adjustment tool as scrupulously as shown on the pictures
below.
Picture 8-11
The tool has to be inserted by the underneath of the washer, and lift to the top. The probe
has to be pulled down till it touches the adjustment tool.
c) Now you can fix this position by tightening the retaining probe ring with its little screw
Ask the user to perform a background before starting the working day. Check that the result is
in range.
Run a QC SFRI bloodtrol and check that the result is in target.
At the end of the day, perform a Shutdown using the SFRI CleanEZ 3.3 when the instrument
prompts you.
Clean the unit panels with neutral detergent. Clean the screen, keyboard and mouse as
requested with adequate cleaner.
At the end of a working week, it is recommended to run the maintenance procedure, launching it from
Service, Maintenance, and using SFRI Clair 3.3
For any brake down, malfunction, that the user is not able to handle, the end user representative will
have to contact the local SFRI representative technical service, in order to proceed immediately to the
relevant repair actions.
The main operations that have to be performed during preventive maintenance (normally performed
in a three hours), are summarized in the PM (Preventive Maintenance) checklist in appendix 4, and the
main steps explained in the procedure bellow.
9.3.2. PROCEDURE
The seal of the vacuum pump piston must be replaced after one year (or after 6 months if number of
samples / day > 30), to ensure proper functioning (stable and accurate vacuum counting value).
Picture 9-1: Vacuum pump assembly with the rod Picture 9-2: the rod
a) Disassemble the bearings bracket, by unscrewing the 3 screws, which allow you to take out
easily the rod and the piston from the block (1, 2 and 3).
Pictures 9-3
b) Unscrew the 3 screws as shown on the picture,
Here is the mechanical assembly remove the bearing bracelet.
alone, with the bearing bracket.
Pictures 9-5
c) Take out the tubes from the vacuum pump, push up gently the rod and the piston to take them
out from the block.
Pictures 9-6
e) Clean the vacuum pump piston with an ultrasonic washing device or distilled water.
Picture 9-8
f) Clean the rod and the gear from old grease g) Unscrew the 4 Screws on the top of the
and lubrifiate again. block
Picture 9-11: Vacuum pump housing and the seal Picture 9-12: Vacuum piston seal S020033
h) Take out the seal from the block and clean the vacuum pump with ultrasonic washing device
or distilled water.
i) Replace the seal with a new one. Re-assemble the parts and respect the order of assembling.
The seals of the dilution block must be replaced after one year (or after 6 months if number of samples
/ day > 30), to ensure the proper functioning.
b) Take out gently the two pistons (Lyse piston and Diluent piston) from the block by pushing
down the metal part to create a space and the pistons for disassembling from the block.
c) Unscrew the five screws to remove Teflon bracket covering seals and O-ring.
e) Use the sample piston to turn the cable gland. “a quarter turn!”
f) Take out the Diluents and Lyse seals from the block.
Diluent piston seal; item code: Lyse piston seal; item code: O-ring sample piston; item
S020032 S020030 code: S020034
h) Clean all the parts of the dilution block by using the cleaning ultrasonic device or any equivalent
cleaning equipment. Re-assemble the sample piston as shown.
In case the counting chamber needs to be cleaned (PLT background or carry over issue), you have to
follow the bellow procedure.
a) Unscrew the screw to disconnect the electrical grounding wire (black cable) from the chamber
(not forget to disconnect also from the CCU Board)
CAUTION: there is only one correct way to place the ruby. Please refer to draft bellow.
Picture 9-35
The seal of the washing head must be replaced after one year (or after 6 months if number of samples
/ day > 30), to ensure the proper functioning.
a) Take out the tubes from the washing head (2 tubes) and unscrew the two screws on the top
of the washing head.
b) Gently push down the washing head, to take it out from the sample probe.
Picture 9-38: Washing probe assembly, exploded view Picture 9-39: O-ring probe
Washing head, item code:
S020034
When the disassembly is done, you must obtain the same number of components as shows the
picture.
Picture 9-48
FOR YOUR SAFETY, BEFORE THE ASSEMBLY OR DISASSEMBLY OF ANY PART OF THE
MACHINE, DON’T FORGET TO SHUT DOWN COMPLETELY THE COMPUTER, TO PUT THE
POWER SUPPLY SWITCH ON “O” POSITION AND TO UNPLUG THE MACHINE.
Picture 10-1
Picture 10-2
a) There are six M2 screws on the back of the machine. Unscrew them to take out the three
panels.
b) You can slowly slide each of them off.
Picture 10-3
Picture 10-4
b) Unscrew all the screws on the board, and take out the board.
Picture 10-6
a) Take out the screws from the façade to disconnect the valves assemblies.
Picture 10-7
Picture 10-8
Picture 10-10
Picture 10-9
Picture 10-11
Picture 10-12
Picture 10-13
Picture 10-14
Unscrew all the screws. For more details, refer to the page 84.
Picture 10-1
5
a) Take out the two circlips shown below.
Picture 10-20
Picture 10-23
Picture 10-24
Picture 10-25
This chapter gives instructions for identifying, troubleshooting, and correcting instrument problems. If
you cannot solve the problems according to this guidance or you wish to get more information, please
contact your local distributor.
11.4. No cleaner
No. Possible cause Solution
1 Cleaner liquid tube bent Check the cleaner liquid tube
2 No cleaner Replace cleaner
3 Cleaner liquid sensor failure Replace cleaner liquid sensor
4 2-way valve leakage Replace 2-way valve
5 The voltage of liquid detection board abnormal Adjust voltage to 3-5 V
6 CCU board broken Replace CCU board
11.5. No Lyse
No. Possible cause Solution
1 Lyse tube bent Check lyse tube
2 No lyse Replace lyse
3 Lyse seal washer broken Replace seal washer
4 Liquid sensor failure Replace liquid sensor
5 3-way valve leakage Replace 3-way valve
6 The voltage of liquid detection board abnormal Adjust voltage to 3-5 V
7 CCU board broken Replace CCU board
11.8. Bubble
No. Possible cause Solution
1 Sample chamber bubble inside Exclude bubble
2 Add reagent too less Re-prime reagent
3 Set up count time too long Set up the count time again
4 Sample aperture broken Replace aperture
5 Count channel leakage Replace part of leakage tube
6 Between back cover and sample chamber Reassemble sample chamber back
leakage cover
7 2-way failure Replace 2-way valve
11.9. Clog
No. Possible cause Solution
Negative pressure not enough Replace the vacuum pump seal washer
1 Replace gear
Replace Vacuum pump rack
2 Chamber aperture clog Clean sample aperture
3 The liquid road of detection unit broken or loose Check tube road
4 2-way valve clog Replace 2-way valve
5 MTB board Replace MTB board
Chamber wiring broken, faulty connection to Connect properly the chamber,
CCU, defective CCU. In that case the hole voltage Replace the chamber.
6
value is 28,50, which is not a real value, it Replace CCU board.
indicates that there is an open circuit.
Safety Symbols
Reagents
REAGENTS REFERENCE VOLUME
SFRI Diluent 3.3 HSL324 20 liters
SFRI Lyse 3.3 HSL304 0,5 liters
SFRI Detergent 3.3 HSG304 2 Liters
SFRI CleanerEZ 5.3 (Conc. Cleaner) HSC304 60 mL
Strong Cleaner HSC104 60 mL
Blood calibrator
NAME REFERENCE QUANTITY
BloodCal R021003 1 x 3 mL
HEMIX 3-30
INSTALLATION CHECK LIST
Customer : Date :
Serial Number :
Environement
Humidity ≤ 70%
Power Supply
Installation
Starting
Training
Report
Send back to SFRI all requested documents
to start warranty support
GENERAL CHECK
MECHANICS CHECK
1/ Clean and lubricate Probe axis (vertical movement - Motor A)
Use PM kit grease if available or similar, clean with tissu paper and acetone
2/ Clean and lubricate Probe Arm axis (horizontal movement - Motor B)
Use recommended grease, clean old grease with tissu paper and acetone
3/ Clean and lubricate Dilution Block axis (Motor C)
Use PM kit grease if available or similar, clean with tissu paper and acetone
4/ Clean and lubricate Vacuum / Pressure Pump Block (Motor D)
Use PM kit grease if available or similar, clean with tissu paper and acetone
FLUIDICS CHECK
1/ Check all tubings (integrity, cleanliness, sealing…) and fittings
(replace any tube, valve or fittings as required)
2/ Check for any foreign body presence in the counting chamber
Remove and clean as required
3/ Check if the chamber is not cracked
Replace if necessary
4/ Check sample probe integrity
Replace if necessary
W.H.V.S. R.H.V.S.
1
2
3
4
5
MEAN
PERFORMENCES CHECK
1/ Run #5 backgrounds
Check if the results are within specs, print and attach
2/ Perform the CV before maintenance procedure
sfri blood control, fifteen replicates
Print and attach
3/ Calibrate if require
Attach the new calibration factors