Professional Documents
Culture Documents
ADL/TSD/MC PLUS/SER/001
REVISION RECORD
REV REASON FOR THE PAGE
No. DATE REVISION AUTHOR CHANGED S/No
1 11/04/2018 JIJU VARGHESE -- 50---------
DISRIPTION
PAGE
S/No. DIVISION/ PART DETAILS NUMBER
Indicates that wearing gloves is mandatory before performing the described operation
due to risk of contact with materials that may be infectious.
NOTE Indicates important information
Indicates that this product may not be treated as household waste. Instead it shall be
handed over the applicable collection point for the recycling of electrical and electronic
equipment. By ensuring this product is disposed of correctly, you will help prevent
potential negative consequences for the environment and human health, which could
otherwise be caused by inappropriate waste handling of this product. For more
detailed information about recycling of this product, please contact your local city
office or your distributor of this product.
NOTE: MISPACOUNTPLUS is an automated hematology analyzer for in vitro diagnostic use in clinical
laboratories by a representative people.
Only human blood or artificial control and calibration blood must be run.
AGAPPE DIAGNOSTICS LTD
The optimum performances can be only achieved if the cleaning and maintenance procedures are
strictly respected.
Due to the use and the environment of this equipment, all parts and surfaces of MISPACOUNTPLUS are
potentially infective. Wearing gloves and hands washing after work completion are strongly
recommended.
Always replace or use parts of the equipment by original parts.
Basic safety precautions should always be taken. If the equipment is not used per the manufacturer’s
instructions, the protective by the equipment may be impaired.
The treatment of waste and the elimination of a part or the complete instrument must be done in
compliance with the local legislation.
Any output or input connections (except the printer and the barcode reader) cannot be done without
representative authorization.
Do not open the door located on the right side of the instrument when hydraulic cycle is in progress, it will
lead to an immediate stop.
2.1 Introduction
MISPACOUNTPLUS is a fully automated analyzer performing hematological analysis on whole blood
collected on EDTA tubes.
Sampling volume is 15.6 µl and analysis cycle duration is 60 seconds.
NOTE: Result is displayed and printed before the end of the analysis cycle.
Here below the list of all parameters determined by the analyzer for each analysis:
Platelet parameters:
Determination
Symbol Description
PLT Total count Measured
MPV Mean Platelet Volume Calculated
PCT* Plateletcrit Calculated
PDW* Platelets Distribution Width Calculated
P-LCR* Large Platelets Counts Ratio Calculated
Note: Parameters followed with (*) are RUO (Research Use Only), to be displayed the option must be
activated.
1. Front cover.
2. Fluidic part.
3. Reagent area.
4. Connection board.
5. External power supply block.
6. Printer (optional).
7. External Barcode reader.
1. Sampling module
2. Syringe module
3. Syringe valve module
4. Counting module
5. Counting valve module
6. Optic Bench
1
3
4 USB Ports
TP/TCIP Port
Not Used
P/S 24V
• 100-240 VAC
• 50/60 Hz
• Single phase with ground
In the case of replacement of the main power cord supplied with MISPACOUNTPLUS,
the new cord must comply with the local regulation.
MISPACOUNTPLUS has been certified with the power supply block provided with. Use
with another external power supply block is not guaranteed.
NOTE: The Automatic barcode identification is available only for these fields.
2.3 Configuration
2.3.1 Standard Configuration
1 analyzer MISPACOUNTPLUS
1 power cord
1 power supply block
1 flat screwdriver
1 user manual
1 certificate of approval
1 diluent pick up tubing
1 waste tubing
Maintenance kit (composition TBD)
2.3.2 Options
Note: If the ambient temperature moves more than 10°C during the working day, MISPACOUNTPLUS must
be calibrated more frequently.
Contact your distributor to use the MISPACOUNTPLUS in other conditions than the
ones described above.
3.2 Unpacking
3.2.1 Unpacking Procedure
MISPACOUNTPLUS is delivered in a cardboard. It is recommended to examine the package visually before
unpacking. If there is any sign of mishandling, damage or else, contact the carrier to claim for damage.
During device unpacking, personal in charge of the installation must control the good presence of all
elements needed for installation comparing to the PACKING LIST.
Installation of the device must be done according to the procedure described hereafter.
If MISPACOUNTPLUS has been stored at a temperature less than 10°C, it must stay
at room temperature during 24 hours to let the time to all elements to reach the
ambient temperature before switching it on.
3.3 Installation
This instruction describes the different stages to follow for the physical installation of MISPACOUNTPLUS
instrument.
1. Remove the instrument from the cardboard and place it on a stable table.
2. Remove the accessories boxes from the reagent compartment and unpack the elements.
4. Connect the diluent pickup tubing to the dedicated hydraulic connector located at the back of the
instrument.
5. Connect the waste tubing to the red hydraulic connector located at the back of the instrument.
6. Tighten the cap of the Lyse pickup tubing (Red color sleeve) and the cap of the Cleaner pickup tubing
(Blue sleeve) to the dedicated bottles.
7. Install lyse and cleaner bottles in the reagent compartment of the instrument.
DILUENT CONTAINER MUST ALWAYS BE PLACED ON THE SAME LEVEL THAN THE INSTRUMENT
10. Connect the power supply cable coming from the power supply block to the instrument respecting
the connection way as shown below.
MISPACOUNTPLUS has been certified with the power supply block provided with.
Any use of another external power supply block could not be guaranteed.
In the case of change of power cord provided with the instrument, the replacing
cord must be in compliance with the local regulation and the instrument
specification in matter of consumption.
NOTE: The power supply block must be placed at the rear of MISPACOUNTPLUS and if possible, upper than
instrument level to avoid any risk of contact with liquid in case of leak.
12. Connect the main cord to a plug of the main power supply.
• 100-240 VAC
• 50/60 Hz
• Single phase with ground
13. Switch on the instrument pressing on the start button and wait for loading until the display of the
login screen.
AGAPPE DIAGNOSTICS LTD
The instrument is now physically installed, follow the following chapters of this document to setup all
options needed for putting into operation.
3.4 STARTUP
STARTUP cycle is dedicated to dayly determine the background values of measured parameters.
It must be launched every day before QC and then before patient’s analysis.
Press on .
The front cycle LED turns red , meaning no cycle can be launched before it turns green.
Instrument will proceed first with counting chambers rinsing then, 1 to 3 blank cycles to control the
background values.
WBC: 0.2
RBC: 0.02
AGAPPE DIAGNOSTICS LTD
HGB: 0.2
PLT: 10
DIF#: 100 (number of pulses within the DIF Plot)
If any level from any parameter is higher than expected value, the system warns the user with an alarm
message “STARTUP FAILED”, it is suggested in this case to perform a new start up.
NOTE: If the user chooses to run patient blood after a startup failed, all results will be displayed and printed
with the indication “Startup failed”
Once the startup is performed, the following screen is display in the RESULTS screen.
Only WBC, RBC, HGB, PLT and DIF# are displayed.
Depending from the level of access which can be Administrator, Operator or Technician, the rights of
access to the menus and sub-menus are different.
Hereafter the menu tree with access levels required.
ARBORESCENCE ACCESS
MENU SUB-MENU FUNCTION OPERATOR ADMINISTRATOR TECHNICIAN
STARTUP
SHUTDOWN
CHANGE LOAD
QC
RESULT LJ GRAPHS
DETAIL
CHANGE
STATS
CALIBRATION
RESULT Calibrate
LOAD
DEL.UNSELECT
REPEATABILITY
DETAIL
RUN
NEXT SAMPLE
SAMPLE
DATE
RESULTS
DETAILS
PRIME ALL
DILUENT
PRIME
LYSE
PRIME
CLEANER
REAGENTS PRIME
WASTE
RESET
Cycle Counters
RESET
Reagents Log
SYSTEM INIT
EVENT LOGS
ERROR LOGS
PRINTERS
MANAGEMENT
COMMUNICATON
COMMUNICATION
SETUP
Add
USERS
Change Password
MANAGEMENT
Remove
SOFTWARE UPDATE
FLUIDIC CONTROL
BLEACH CLEANING
DRAIN BATHS
BACKFLUSH
APERTURES
BACKFLUSH OPT.
BENCH
NEEDLE
DISMANTLING
CHECK ROCKER
PARK MOTORS
RINSE
CLEAN
DRAIN FOR PACK UP
SYRINGE GREASING
DRAIN FLOW CELL
EV1
EV2
EV3
EV4
EV5
TROUBLESHOOTING EV6
EV7
EV8
EV9
EV10
EV11
EV12
CHECK
EV13
SENSORS/VALVES
EV14
EV15
EV16
EV17
EV18
ALL EV ON
EV CHASER
SET HGB LED OFF
SET CO ON
SET OPT LED ON
TEST VACUUM
PUMP ON
CHECK SYRINGE
CHECK NEEDLE
ADJ. LED
ADJ. OB
ADJUST DIF CHECK OB
ADJ.WBC
CHECK WBC
WBC ADJUST
TECHNICIAN
WBC CHECK
RBC ADJUST
ADJUST OTHERS
RBC CHECK
HGB ADJUST
PRESSURE ADJUST
SYSTEM CONFIG
LOG OUT
Chapter 6 Technology
Hydraulic connection
Nozzle holder
Hydraulic connection
Absorbance
Eosinophils Neutrophils
Lymphocytes
AGAPPE DIAGNOSTICS LTD Monocytes
Diffraction
YOUR BEST PARTNER IN DIAGNOSTICS Basophils 29
DOC No. ADL/TSD/MC PLUS/SER/001
The White Blood Cell Total Count is obtained by Impedance metric in the WBC counting chamber; the
other ten parameters are obtained by flow cytometry measurement.
WBC Total Count calculation is based on the pulses distribution curve after the action of the lytic reagent.
The lyse reagent destroys the RBC and their stromas and acts on the cell cytoplasmic walls for better
discrimination into the optic measurement.
L1 L5
WBC histogram is displayed after pressing on DIF Plot on the result screen.
L1 and L5 thresholds are displayed on curve in full vertical blue color line.
NOTE: first peak on the left side of the histogram represents the lymphocytes cells, the other one located
on the right side represents all the others WBC populations.
WBC 5 differential absolute values and percentages are obtained by optic measurement.
The measured pulses on the two optical channels are displayed on DIF Plot ALL (Y axis) and FSC (X axis).
Each dot on the DIF Plot represents the height in ALL and FSC of each pulse
The erythrocyte analysis is done by impedance metric in RBC counting chamber. Seven parameters are
obtained:
R1 R2
Hematocrit (HCT) is measured by integration of the volume of the red blood cells which flow in the
RBC counting chamber aperture.
HCT = MCV x 10
RBC
MCV = HCT x 10
RBC
The RBC distribution curve analysis allows the measurement of RDW which is an expression
of the standard deviation compared to MCV. This parameter evaluates the RBC anisocytosis.
RDW = k x SD
MCV
Mean Corpuscular Hemoglobin (MCH) calculation is obtained from HGB and RBC by the following
formula
MCH = HGB x 10
RBC
Mean Corpuscular Hemoglobin Concentration (MCHC) is made from HGB and HCT by the formula
below:
HCT
RDW-SD is an actual measure of size. It is derived by finding the width at the 20% height
of the distribution histogram.
RDW-CV is determined by taking the standard deviation of RDW-SD and the mean
corpuscular volume (MCV) number.
Parameters Pathologies
PLT Platelets Thrombopenia PLT<PLT b
Thrombocytosis PLT>PLT h
MPV Mean Platelet Volume Giant platelets MPV> MPV h
Small platelets MPV<MPV l
PCT Thrombocrit
PDW Platelet Distribution Width
PLCR Platelet Large Cell Ratio
CP1 CP2
P CP3
10000
Platelet Large Cell Ratio (PLCR) indicates the percentage of large platelets with a volume >12 fL. Aside
from the two flexible discriminators which delimit the volume distribution curve, there is additionally
a fixed discriminator at 12 fL (marked in red on below picture). The PLCR is the percentage of cells
higher than 12fL regarding the whole platelets count.
6.6 Alarms
MISPACOUNTPLUS manages different alarms. These alarms allow the user to be alerted if there is a mistake
which can affect the quality of the results. These alarms appear on screen at the right of the result.
NOTE: Whenever one of the following symbol is triggered (*, -, +, ++++) display tagged result in bold (flag
included)
Whenever one of the following flag is triggered (L, l, h, H) display tagged result normally and flagged
in bold.
Whenever one of the following flag is triggered (L, l, h, H) display tagged result normally and flagged
in bold.
Change color of all flagged result to a specific color in accordance to the UI specifications (flag
included):
When result is flagged with: *, +, ++++,!, the parameter printout on table view is the parameter
value followed or replaced (++++) by the appropriate symbol
When result is flagged with L,l, h or H, the parameter printout on table view is in reverse video
only
L1 L5
Two editable thresholds L1, L5 enable to discriminate the resistive count flags.
MORPHOLOGICAL ALARMS
On Curve
The measured pulses on the two optical channels are displayed on DIF Plot ALL (Y axis) Vs FSC (X axis).
MORPHOLOGICAL ALARMS
On DIF Plot
Trigger Condition Alarm Short version Alarm Flags enlarged
Presence of cells in the zone in Review on Smear:
regard of the total number of N1 Debris or Small Cells
leucocytes in the DIF Plot. Platelet Aggregates
Review on Smear:
Presence of cells in the zone in
Probable Incomplete Erytrolysis
regard of the number of N2
Platelet Aggregates
lymphocytes.
Erythroblasts
Presence of Immature Cells (from Review the DIF
the mono or polynucleated cells IMM Review on Smear:
line) Immature Cells
Review the DIF
Presence of atypical lymphocytes ALY Review on Smear:
Atypical Lymphocytes
Review the DIF
Presence of atypical lymphocytes
RL Review on Smear:
or basophiles.
Right Lymphocytes
Presence of basophiles, small
Review the DIF
neutrophils (without granulations HL
High Lymphocytes
or few segmented), band cells.
Presence of small neutrophils
(without granulations or few Review the DIF
NL
segmented), band cells or hyper Low Neutrophils
basophil monocytes.
Presence of giant neutrophils,
hyper segmented neutrophils, Review the DIF
NH
eosinophils with few granulations High Neutrophils
or damaged eosinophils.
Two (2) editable thresholds R1 and R2 enable to discriminate between microcytes, normocytes and
macrocytes. CR1 CR2
100%
68.26% of total
RDW-SD
20%
MCV
MCV is measured on the whole RBC acquisition.
HCT parameter is calculated from MCV and RBC parameters.
MCHC parameter is calculated from HGB and HCT parameters.
MCH parameter is calculated from HGB and RBC parameters.
RDW parameter is calculated on curve distribution (defined as the CV of 68.26% of total distribution
area)
RDW-SD parameter is calculated on curve distribution (defined as curve width at 20% of peak)
MORPHOLOGICAL ALARMS
On The Curve
Trigger Condition Alarm Short version Alarm Flags enlarged
Determination of the population defined
from channel 0 to CR1.
The alarm is raised if this population is R1 Microcytes
higher than an absolute limit OR a
percentage of the RBC population.
Determination of the population defined
by CR2 threshold and curve ending.
The alarm is raised if this population is R2 Macrocytes
higher than an absolute limit OR a
percentage of the RBC population.
MORPHOLOGICAL ALARMS
On The Curve
Trigger Condition Alarm Short version Alarm Flags enlarged
Determination of the population defined
from channel 0 to CP1.The alarm is
raised if this population is higher than an P1 Platelet Debris
absolute limit OR a percentage of the
PLT population.
1. Sampling module
2. Syringe module
3. Syringe valve module
4. Counting module
5. Counting valve module
6. Optic Bench
1
3
6.8 Software
MISPACOUNTPLUS software runs using the Linux operating system. The software is embedded on a Q7 CPU
board.
This board is equipped with an Intel ATOM CPU (32 bits), RAM memory and flash where software and data
are stored.
: Allows to opens a contextual menu for actions linked to the current menu (save, delete,
print, sent…).
An exit button allows to close the tools window and return to current menu.
: Allows coming back to the MENU display where ever you are in the arborescence.
Instrument Model
Operation System Version
Software version
FPGA / µblaze versions
Algorithm (dynamic clustering version)
Cycles Modules
Fluidic Module: N/A
Instrument’s serial Number
User - Login level
IP address
6.8.2 Windows
MispaCountPlus displays few types of window to communicate with the operator in case of needs.
1. Confirmation message.
2. Information Message
Chapter 7 Specifications
Measuring
Measurand Units* Limit Operating Range
Range
HCT % 5 – 70 ± 2 or ± 3% 0-80
MPV fL 5 – 25 ± 1 or ± 10% 0 – 25
LYM, MONO,
NEU, EOS, BASO, 103/µL 0-100 N/A 0-100
ALY, IMM %
7.1.2 Background
Maximum background counts during STARTUP cycle
7.1.3 Precision
Short term (within run) imprecision will be tested by assaying the same normal whole blood (collected in
K2EDTA) specimen consecutively 20 times.
Repeatability Limits
Measurand* Ranges Tested
Whole blood (%CV)
7.1.4 Carry-Over
The following table shows carryover percent for WBC, RBC, HGB and PLT. Carryover will be determined by
running linearity kit specimens with high target values of WBC, RBC, HGB and PLT. Each specimen will be run
in triplicate followed by three blank runs. Carryover is calculated and expressed as a percentage using the
following formula:
WBC /
> 0 < 0.2 >15 <1%
DIFF(103/µL)
7.1.5 Correlation
Specimens from normal blood donors and specimens from patients identified with normal and abnormal
hematology results will be run in duplicate on test systems and comparative Systems using same
measurement technique.
All results have no alarm or flag.
7.2 Units
MISPACOUNTPLUS is multi units for hematology result.
US
Parameters SI SI MOD JAPANESE
(Standard)
L: Liter
µ: micro (10-6)
g: gram
dl: deciliter
f : femto (10-15)
mmol : millimole (10-3 mole)
mol: mole
SI MOD: SI modified (mole instead of g)
JAPANESE: Commonly used in Japan
If MISPACOUNTPLUS has been stored at a temperature less than 10°C, it must stay at
room temperature during 24 hours before switching it on.
If the room temperature moves more than 10°C during the working day,
MISPACOUNTPLUS must be calibrated.
7.4.1 Instrument Specifications
Here below the physical specifications of the instrument:
- Dimensions: Height: 405 mm (approx.) * Width: 270 mm (approx.) * Depth: 430 mm (approx.)
- Weight: 12kg (approx.)
- Power supply Input: 100-240VAC 50-60Hz
- Power supply Output: 24V – 6.75A
- Electric consumption: 160W
- Screen: LCD Touch-screen 8.4 inch (800*600)
- Memory capacity: 35000 Files (Demographics, results and histograms)
QC: 12 lots (100 results per lot)
- Connection: 5 USB ports/ Ethernet-RJ45/ Serial LIS-SUB D9, PC connection/Serial Port
If the reagent has been stored at a temperature less than 10°C, it must stay at room
temperature during 24 hours before use.
GENERALITIES: Some abnormal samples may give incorrect results by automated cell counting methods.
The following table shows examples of specific specimens that could cause errors.
Each result for a new patient out of lab linearity limits or with an alarm must be
checked with a conventional method or checked with blood smear.
7.6.1 Interferences
Chapter 9 SERVICE
9.1 Introduction
NOTE: Can be used whether the instrument is switched on with the fluidic door opened and due to that,
did not performed the automatic mechanic initialization.
9.3 LOGS
Log depth (EVENT+ERROR) is set to 500 entries.
When the number or EVENTS+ERRORS is higher than 500, older messages are removed from the database.
9.5.1 BACKUP
In BACKUP field, check the options you want backup “Data and Setup” and/or “.csv file” then select
.
9.5.2 RESTORE
In restore field, press on , the following window is displayed.
NOTE: It is recommended to perform backup regularly because in case of trouble it would be the easiest
way to restore all data in the state of the last backup save.
9.6 SETTINGS
This menu is dedicated to set all the instrument with different options like printer, communication, limits,
flags, etc…
Select from menu, the following screen is displayed.
Auto increment
Check in box if you want auto-increment of SID from start number specified.
QC
Check in the box if you want QC alert displayed and printed on patient files (QC Not Done and QC Failed)
RUO
Check in the box if you to see displayed the RUO parameters.
Note: See below the difference of display between with and without RUO parameters.
9.6.1.2 UNITS
Select from menu, the following screen is displayed.
This screen gives the possibility to the user to choose the units among the following list
Select the model of unit you want use then press to valid, the following window is displayed.
Thresholds modification can affect the quality of the results or can affect the alarm
detection. We recommend to modify these values only after training.
Thresholds modification can affect the quality of the results or can affect the alarm
detection. We recommend to modify these values only after training.
NOTE: In both CBC & DIF thresholds and flags menus, the button allows returning to the
original values.
AGAPPE DIAGNOSTICS LTD
Once modifications are done, press to validate or to exit without any modification.
Once modifications are done, press to validate or to exit without any modification.
The modification of these factors without running a calibration blood could affect the
quality of the result.
If the calibration factors are manually modified, the calibration information in the
calibration screen will be flagged with “MODIFIED” and previous calibration results are
modified
If the calibration factors are manually modified, the following prompt is displayed to
inform the biologist that the calibration results will be removed.
9.6.2 DATE/TIME
To change the Date, select the field among day/month/year and change the value using the arrows or
enter it manually using the displayed numeric keyboard.
To change the date format, press on the arrow and choose the desired format.
D for day
M for month
Y for year
To change the time, select the minute or hour field and change the value using the arrows or enter it
manually using the displayed numeric keyboard.
To change the time format, select the arrow and choose the desired format.
Once modifications are done, press to validate or to exit without any modification.
To enable automatic power up setting, Select Enable and choose the time and date for the automatic
power up.
To modify the Auto clean frequency, adjusted by default to be done every 100 analyses, the value can be
set from 10 to 5000.
If you want set an automatic shutdown, check in the option enable and enter the time chosen.
NOTE: Time is expressed in minutes and Shutdown frequency can be set from 30 to 720.
Once modifications are done, press to validate or to exit without any modification.
9.6.4 PRINTER
This menu is dedicated to set the different possible printing options.
Select from menu, the following screen is displayed.
Report Headers: Allows to enter the Laboratory header using touch screen keyboard.
Patient Report Options: Options selected will be printed on the patient report.
Control Report Options: Allows to select LMG format, percentage or absolute value for all analysis
and not only for control.
Once modifications are done, press to validate or to exit without any modification.
9.6.4.2 PRINTER MANAGEMENT
This screen is dedicated to the printer installation.
It must be used the first time the printer is connected to the instrument, following the instruction below.
Connect the printer to an USB port located at the rear of the instrument.
Switch ON the printer.
Select , the following screen is displayed.
NOTE: It needs few seconds for the instrument to detect the printer as in the example below.
NOTE : As in the exemple above, if the field of the printer, connected and detected, is not present in the
list, choose pcl3 or pcl6 drivers depending from printer compatibility.
Generally: pcl3.ppd in dedicated to black & White printers and Pcl6.ppd for colors printers.
Exit the menu pressing PREVIOUS, then go back and check that the printer is well installed.
9.6.5 Communication
This menu allows to setup the connection between MISPACOUNTPLUS and the Host Computer of the Lab.
Select from menu, the following screen id displayed.
Communication field allows the user to select the type of communication required.
o COMMUNICATION FORMAT, at that time only CSV format (Coma Separated Values)
NOTE: MISPACOUNTPLUS can be connected to the host computer in two different ways:
1. Serial link (type RS232)
2. Ethernet
3. Select NONE if no communication is required.
allows to configure the communication data accordingly to the host computer dat.
Auto Transmit field provide the possibility to choose the data to be transmitted. Select the concerned
options.
This menu allows to add, to modify or to delete an operator and/or a biologist Login information.
Select from menu, the following window is displayed.
9.6.6.1 Add
Select to add a new operator or biologist and fill in the different fields.
9.6.6.3 Remove
Select to delete the selected user, the following window is displayed.
Connect to the front USB port, USB drive containing the software update (two files), then press ,
the following screen is displayed.
NOTE: Software upgrade can take few minutes, do not remove the USB drive or power off the instrument
until the following message.
9.7 TROUBLESHOOTING
This menu gives access to different fluidic options as well as mechanical checks.
Select , the following screen is displayed:
NOTE: Control cycle allows to control mechanic, hydraulic and electric functions to completely reinitialize
the instrument when it is needed.
2. Instrument begins to drain the counting chambers and the following window is displayed.
3. Open the fluidic door and put 4ml of 12° Hypo chloride solution in each counting chamber. Close the
fluidic door when bleach dispense is done, then press . The system will perform fluidic actions
cleaning the mains counting module parts like apertures, counting chambers and optic flow cell.
NOTE: On each counting bath, an Arrow indicates the volume of 4ml for bleach P-5.
The bleach cycle takes 15 minutes to be completed.
It is not possible to use the instrument during that time.
NOTE: This option is principally used by field FSE in case of parts replacement which does not require a
complete instrument draining.
*backflush onto the apertures: The system push cleaner under pressure into the WBC and RBC apertures in
order to remove a potential clogging. It can be used in case of permanent rejection for one or few measured
parameters.
option allows to perform a backflush onto optic flow cell* in case of needs.
*backflush onto optic flow cell*: The system push cleaner under pressure into the flow cell in order to
remove a potential clogging. It can be used in case of permanent rejection for optic measurement.
option allows moving automatically the sampling module to give the access to the
needle in case of needs (needle and/or rinse head O-ring replacement.
Hereafter the instruction to replace the needle and/or the rinse head O-ring.
2. Pull on the top of the needle to remove it from the needle carriage.
3. Pull on the rinsing head and remove it from the sampling module.
AGAPPE DIAGNOSTICS LTD
4. Pull up the needle to remove it from the rinsing head. Disconnect it from tubing and remove it
from the instrument.
Wear rubber gloves and wash hands with a disinfectant after completion of work.
option allows controlling the functionality of the sampling module transversal axis; it
checks the motor and sensors.
option allows to place the syringe pistons into the maximum high position.
9.7.8 RINSE
option allows the counting chambers rinsing, following tool bar indicates the progress of
the rinse cycle.
At the end of the rinse cycle the following window indicates the user that rinse cycle is completed.
9.7.9 CLEAN
option allows cleaning the apertures with cleaner. It performs three back flush, a
drain chambers and refill.
NOTE: This option must be always used before a long term shut down.
: This option allows moving the pistons down in order to perform the greasing.
AGAPPE DIAGNOSTICS LTD
NOTE: The piston greasing must be performed every 6 months, please proceed as describe in the
procedure below.
Operators must be trained before to perform the maintenance tasks. Due to moving
parts risk of injuries is present.
2. Wear rubber glove on one hand and place a bit of silicon grease at the tip of the index.
NO GREASE ON SAMPLING
PISTON
NOTE: With a tool key type T20, turn the two bigger pistons (waste pistons) in order to spread
the grease all around the pistons.
HOMES STATES
SWITCHS
COUNT
THERMAL
Instrument temperature
VALVES
CHECK DEVICE
option allows controlling the syringe module functionality, this function checks the
syringe motor and sensor.
option allows controlling the functionality of the Y axis of the sampling module, this
function checks the motor and sensors.
9.7.15 Maintenance
The quality of the results and the reliability of MISPACOUNTPLUS are directly linked to the strict
respect of the maintenance hereafter described.
To perform the maintenance and the repair described in this Chapter, it is mandatory
to have received adequate training, to wear rubber gloves and wash hands with a
disinfectant after completion of work.
NOTE: This maintenance table is dedicated to the user and to FSE. It is established an average
workload of 50 daily patients. For bigger workload, please increase proportionally the frequency of
maintenance actions.
Needle
Motor
Pistons O-ring
Startup Shutdown Bleach screw
greasing replacemen greasing
t
U
Daily
Weekly
Semi
annually
Annually
Troubleshooting
This Chapter allows knowing what to do when a troubleshooting message appears on the screen.
In any case, if a problem is not solved, contact your distributor.
System detected Optical stop cock as closed. Open the stop cock if it’s closed.
System detected that temperature is < to Wait a moment, the heater will reach set
18°C or > to 36.5°C. points.
System detected a reagent temperature Wait a moment, the heater will reach set points
that is < to target – 2.5°C.
System communication with I/O board is out Check HGB and FSC/ALL boards connection.
at automaton power on.
Reboot the automaton.
Auto clean cycle initiated. Press on and wait the end of the cycle.
The system detected the fluidic door opened. If the fluidic door is closed, verify the good
functionality of the fluidic door switch and its
physical adjustment.
The adjustment of the HGB LED is failed. 1. Verify that WBC bath is filled with
diluent during HGB LED adjustment.
2. Change HGB board.
3. Change WBC bath.
Note: HGB LED light flux must be included in the
range [18000 ; 22000] after gain adjustment.
Needle not in home position detected before Press on to cancel the window.
to perform cycle.
Perform a motor initialization.
Cycle prime all is mandatory after clean out. Press on and perform a prime all cycle.
Rinse cycle is mandatory after drain cycle. Press on and perform a rinse cycle.
Start-up cycle mandatory after shutdown. Press on and perform Start-up cycle.
System detects there’s no bleach during Press on and perform motor init.
bleach cycle.
Redo bleach cycle adding bleach when system
require.
System detected start up cycle was not done. Run START UP cycle.
System detected lot number already used Redo using another lot number
System detected default during reagent data Correct the default entering good data
recording
System detected diluent reagent is almost You still can perform ten analysis then system will
empty. generate diluent is empty
System detected failure during reagent data Correct the default entering good data
recording
System detected default during reagent data Correct the default entering good data
recording
System detected Cleaner bottle almost empty You still can perform ten analysis then system will
generate cleaner is empty
System detected lyse bottle almost empty You still can perform ten analysis then system will
generate lyse is empty
Chapter 10 SHUTDOWN
1. From the main menu, press SHUTDOWN .
3. The hydraulic circuit of the counting and the optic modules will be rinsed.
4. Counting chambers will be filled with cleaner reagent.
5. At the end of the shutdown cycle, MISPACOUNTPLUS will automatically turn off.
6. Shut Down can be set to be automatically performed (see ).
NOTE: After a shutdown, it is not possible to perform an analytical cycle without performing startup first
MISPACOUNTPLUS must stay at least with cleaning solution for three hours every 24
hours.
Introduction:
The present document, dedicated to the user and service engineers, details the needed information in
matter of error message.
Error message occurs when system detects a default which could have an impact on the instrument
(damage) or on the quality of the analysis (false result). When the system detects a default, any action in
progress is then stopped immediately and the user is alerted by a popup displayed on screen.
On cycle completion (auto stop or emergency stop), all motors, aperture currents, optical LED and valves are
deactivated. All error messages are saved in the error log file and can be consulted, printed or save on USB
flash drive as needed.
if for any reason the user wants to stop the instrument, an emergency stop can be generated by simple
pressing on the on/off button.
Cycle stopped
upon user 1. Fix the Issue
CYCLE STOPPED CYCLE IS
request
BY USER STOPPED 2. Press on
(emergency 3. Select FLUIDICS CONTROL CYCLE
stop button).
If the adjustment fails, a prompt informs the operator, the background check is done ignoring the
haemoglobin. The haemoglobin is invalidated until an adjustment of the LED succeeds.
1. Press on
the operator 2. Check presence of diluent inside WBC
STARTUP bath.
STARTUP cycle can run Sample.
FAILED – HGB 3. Check all connections
is failed HGB is
ADJ FAILED 4. Perform HGB adjustment
invalidated 5. Check HGB LED (change is necessary)
6. Check HGB board (change is necessary)
7. Check CPU board (change is necessary)
If the level is higher, the instrument will display the following prompt:
STARTUP 4. Press on
FAILED – STARTUP cycle the operator 5. Perform a second startup
BACKGROUND is failed can run Sample 6. Perform bleach cycle
CHECK FAILED 7. Troubleshoot on the concerned
parameter
When a cycle is trigged while another one is being executed, the following prompt is displayed
Trying to run
CYCLE IS 1. Press on
CYCLE BUSY cycle while
REFUSED 2. Wait the end of the cycle in progress then
cycle is running retry
When trying to run a cycle after an emergency stop the following prompt is displayed
Appears when
trying to run a
cycle after an
FLUIDICS emergency
CONTROL stop. Fluidic CYCLE IS
1. Press on
CYCLE NOT control cycle is REFUSED
2. perform FLUIDICS CONTROL cycle
DONE mandatory
after
emergency
stop.
If the user attempts to run a cycle after a clean out without performing a Prime ALL, the following prompt is
displayed (except when the user requests STARTUP)
If the Startup is not done and the user attempts to run analysis cycle, the following prompt is displayed
ANALYSIS CYCLE
STARTUP NOT STARTUP cycle
IS NOT 1. Press on
DONE is not done
ALLOWED 2. Select STARTUP cycle
If the user attempts to run a cycle after a drain or a drain flow cell without performing a rinse cycle, the
following prompt is displayed
Rinse cycle is
mandatory ANALYSIS
RINSE CYCLE
after drain CYCLE IS NOT 1. Press on
NOT DONE
cycle or drain ALLOWED 2. Select RINSE cycle
flow cell.
If the fluidic door is open, the short fluidic mechanical initialization is not done and the following prompt is
is displayed
Motors
MOTOR INIT Emergency
initialization is 1. Press on
NOT DONE stop.
not done. 2. Perform a motor initialization
Note: Opening the fluidic door generates an emergency stop of the running cycle, except during the waiting
message of a specific cycle (for example bleach cycle and clean out).
Fluidic door
opened
FLUIDIC during a
EMERGENCY
DOOR fluidic cycle 1. Press on
STOP
OPENED except when 2. Close FLUIDIC DOOR
the user is
asked for
Note: Opening door moves probe up if the probe is down (Probe will be up at any door opening for all user’s
login).
When the fluidic door is required to be closed, the following prompt is displayed once
Fluidic door is
PLEASE CLOSE open and/or is
FLUIDIC DOOR required to be N/A 1. Press on
TO CONTINUE closed to run 2. Close FLUIDIC DOOR
the cycle
When fluidic door is still not closed after “PLEASE CLOSE FLUIDIC DOOR TO CONTINUE” occurred once
Note: When the measured pressure is out of the range defined in the fluidic cycle, an error is raised and the
current cycle is stopped.
1. Press on
Vacuum 2. Check the presence of diluent in rinse head fluidic
circuit
NEEDLE failure
Emergency 3. Check if tub clogged or pinched in rinse head
RINSING during the
stop. fluidic circuit
DEFAULT needle 4. Check the rinse pump
rinsing 5. Check the inline pressure sensor
6. Check valves #3,4,5,6,18,12 in check sensors
screen
1. Press on
Vacuum 2. Check the presence of reagent in counting bath
failure 3. Check the CPU pressure sensor
DRAIN
during bath Emergency 4. Check if tub clogged or pinched in drain bath
BATH
draining in stop. fluidic circuit
DEFAULT 5. Check valve #1 or 2 depending from the bath
analysis
cycle concerned
6. Check valve #17 and 8 (atmosphere circuit)
7. Check for leak on waste syringes
Vacuum
failure
VACUUM 1. Press on
during Emergency
COUNTING 2. Check the CPU pressure sensor
counting stop.
DEFAULT 3. Check for leak on waste syringes
phase in 4. Check syringe module
analysis cycle
Vacuum
failure at Emergency 1. Press on
NO DILUENT 2. Replace the empty diluent container by a new one
begin of bath stop.
draining
Vacuum 1. Press on
SYRINGE failure 2. Check for leak on waste syringes
Emergency 3. Check for disconnected tubing
VACUUM during test
stop. 4. Check the CPU pressure sensor
DEFAULT syringe
5. Check syringe module
cycle.
Pressure failure during test syringe cycle (on draining waste from syringe)
Pressure 1. Press on
failure 2. Check valve #7
WASTE during test 3. Check for pinched tubing on waste line
Emergency
DRAINING syringe cycle 4. Check syringe module
stop.
DEFAULT (on draining 5. Check the CPU pressure sensor (Change CPU as
waste from necessary)
syringe)
1. Press on
Pressure
PUMP Emergency 2. Check for pinched or clogged tubing on pump line
failure during
DEFAULT stop. 3. Check valve #3 (change as necessary)
pump test 4. Check in line sensor (change as necessary)
5. Change the pump (change as necessary)
Detected air
NO BLEACH Emergency 1. Press on
on bleach
IN THE BATH stop. 2. Redo bleach cycle
cycle. 3. Check for leakage
Note: When the relative difference of the measured pressure to the previous check is out of the range
defined in the fluidic cycle, an error is raised and the current cycle is stopped.
Vacuum
stability 1. Press on
SYRINGE
check 2. Check for leak on waste syringes
VACUUM Emergency
failed 3. Check for disconnected tubing
STABILITY stop.
during 4. Check the CPU pressure sensor
DEFAULT 5. Check syringe module using CHECK SYRINGE
syringe
vacuum option
Vacuum
stability
VACUUM 1. Press on
check
COUNTING Emergency 2. Check the CPU pressure sensor
failed
STABILITY stop. 3. Check for leak on waste syringes
during 4. Check syringe module using CHECK SYRINGE
DEFAULT
counting option
vacuum
7. Press on
Vacuum 8. Check the presence of diluent in rinse head fluidic
stability circuit
NEEDLE 9. Check for tubing clogged/pinched in rinse head
failed Emergency
RINSING fluidic circuit
during the stop.
DEFAULT 10. Check the rinse pump USING TEST PUMP option
needle 11. Check the inline pressure sensor USING TEST
rinsing. PUMP option
12. Check valves #3,4,5,6,18,12 in check sensors
screen
Note: When a motor is supposed to return to its home position, if it is not detected, or step loss is detected,
an error is raised, and the current cycle is stopped.
Note: When a motor is in its home position while it is not supposed to be, an error is raised, and the current
cycle is stopped.
Motors 1. Press on
MOTOR INIT Emergency
initialization is 2. Perform SYSTEM INIT
NOT DONE stop.
not done.
1. Press on
Steps lost on
Emergency 2. Check for mechanical hard point on needle
NEEDLE GAP the needle
stop. movement
motor. 3. Check Needle using CHECK NEEDLE option
4. Check Needle sensor CHECK NEEDLE option
Needle cannot join its home
1. Press on
Needle not in- 2. Check Needle sensor using CHECK NEEDLE
home position option
NEEDLE HOME Emergency
detected 3. Check needle sensor using CHECK NEEDLE
NOT FOUND stop.
before to option
perform cycle. 4. Check CPU ²
Home sensor had been detected but the sensor is not in the home position
1. Press on
Steps loss on
Emergency 2. Check Rocker module using CHECK ROCKER
ROCKER GAP the rocker
stop. option
motor. 3. Check Rocker sensor using CHECK ROCKER
option
Home sensor had been detected but the sensor is not in the home position
1. Press on
Home rocker 2. Check Rocker sensor using CHECK ROCKER
ROCKER HOME Emergency
detection option
ERROR stop.
error 3. Check CPU (change as necessary)
1. Press on
Home rocker 2. Check Rocker sensor using CHECK
ROCKER HOME
cannot join its Emergency stop. ROCKER option
NOT FOUND
home 3. Check Rocker module using CHECK
ROCKER option
4. Check CPU (change as necessary)
Message when Home sensor had been detected but the sensor is not in the home position
1. Press on
SYRINGE HOME Home Syringe
Emergency stop. 2. Check syringe sensor using CHECK
ERROR detection error
SYRINGE option
3. Check CPU (change as necessary)
1. Press on
Home Syringe 2. Check Syringe sensor using CHECK
SYRINGE HOME
cannot join its Emergency stop. SYRINGE option
NOT FOUND
home 3. Check Syringe module using CHECK
SYRINGE option
4. Check CPU (change as necessary)
1. Press on
Steps loss on
2. Check Syringe module using CHECK
SYRINGE GAP the syringe Emergency stop.
SYRINGE option
motor. 3. Check Syringe sensor using CHECK
SYRINGE option
Note: Communication with the HGB, FSC and ALL boards is checked (unplugged board).
1. Press on
2. Reboot the automaton
The system 3. Check HGB and FSC/ALL boards
BOARDS detected connection.
EMERGENCY
COMMUNICATION communication 4. Check HGB and FSC/ALL cable
STOP
ERROR error with If one of the cable above was
satellite board(s). disconnected, please connect the
cable to the board and reboot the
instrument
5. Check CPU board.
Message when error is detected during the valve command, the fluidic cycle is stopped and an error
message informs the operator.
1. Press on
Valve [EV label] is 2. Verify connections on valve [EV
LABEL]
EV [EV LABEL] not connected
EMERGENCY 3. Verify electrical continuity on [EV
COMMAND (plugged or out
STOP LABEL]
ERROR of order) or is 4. Replace valve [EV LABEL]
short-circuited 5. Check fuse (change as necessary)
6. Check CPU board (change as
necessary)
Note Heating Temperature Security and control Reagent temperature are checked against overflow.
A prompt
informs the
MAXIMUM user: Reagent 1. Press on
REAGENT temperature 2. Check cable connections
Reagent 3. Check the heater (change as necessary)
TEMPERATURE over 60.
temperature > Note: Instrument must be restarted after issue
REACHED. Heating is
60°C fixing to unlock the error
HEATER IS stopped.
STOPPED.
Run sample
inaccessible.
Note Heating system is checked regarding efficiency (heating without temperature rising).
Message when Reagent heating at 100% and no temperature increase during 2mn
Heating is
Reagent 1. Press on
stopped; A
heating at 2. Check cable connections
prompt informs 3. Check the heater
REAGENTS 100% and no
the user: 4. Check CPU
HEATER IS temperature
Reagent Note: Instrument must be restarted after issue
STOPPED increase during
heating failed. fixing to unlock the error
2mn (less than
Run sample
0.5 increase)
inaccessible.
Run sample
inaccessible
(except with
SERVICE or
higher rights).
REAGENT These
TEMPERATURE conditions
If the reagent
IS OUT OF disable the 1. Press on
temperature
RANGE. probe down 2. Wait for set temperature reached
is < to target –
function.
ANALYSIS ARE 2.5°C
NOT ALLOWED The error
prompt
appears when
user goes in
screen where
you can run
sample.
If the
INSTRUMENT 1. Press on
instrument A prompt
TEMPERATURE 2. Wait for set temperature reached
temperature informs the
OUT OF 3. Check cable connections
is < to 18°C or user 4. Check the heater
RANGE.
> to 36.5°C 5. Check CPU
PLEASE
CHANGE No cycle can 1. Press on
CLEANER: If Cleaner is be launched 2. Change the cleaner bottle
empty (except in R&D 3. Perform cleaner priming
CONTAINER IS Mode)
EMPTY
PLEASE
No cycle can 1. Press on
CHANGE
If Diluent is be launched 2. Change the diluent container
DILUENT:
empty (except in R&D 3. Perform diluent priming
CONTAINER IS
Mode)
EMPTY
PLEASE
REPLACE 1. Press on
Diluent No cycle can
DILUENT Expiration be launched 2. Change the diluent container
CONTAINER: date is (except in R&D 3. Perform diluent priming
attempted Mode)
REAGENT IS
OUT OF DATE
PLEASE
REPLACE no cycle can be 1. Press on
Cleaner
CLEANER launched 2. Change the lyse bottle
Expiration date
CONTAINER: (except in R&D 3. Perform lyse priming
is attempted
REAGENT IS Mode)
OUT OF DATE
PLEASE
REPLACE no cycle can be
Lyse Expiration 1. Press on
LYSE launched 2. Change the lyse bottle
date is
CONTAINER: (except in R&D 3. Perform lyse priming
attempted
REAGENT IS Mode)
OUT OF DATE
PLEASE
no cycle can be REPLACE
Lyse Open 1. Press on
launched LYSE 2. Change the lyse bottle
date is
(except in R&D CONTAINER: 3. Perform lyse priming
exceeded
Mode) REAGENT IS
OUT OF DATE
PLEASE
REPLACE no cycle can
Diluent Open 1. Press on
DILUENT be launched 2. Change the diluent container
date is
CONTAINER: (except in R&D 3. Perform diluent priming
exceeded
REAGENT IS Mode)
OUT OF DATE
PLEASE
REPLACE no cycle can 1. Press on
Cleaner Open
CLEANER be launched 2. Change the cleaner bottle
date is
CONTAINER: (except in R&D 3. Perform cleaner priming
exceeded
REAGENT IS Mode)
OUT OF DATE
REAGENT 1. Press on
Incorrect
AUTENTIFICATION NA 2. Enter the correct code then validate
code entry
FAILED
Message when Reagent lot (lot number + bottle SERIAL) already exists in the reagent log
Reagent lot
(lot number + 1. Press on
REAGENT bottle SERIAL) 2. Change the diluent data
NA
ALREADY USED already exists 3. Perform diluent priming
in the reagent
log
An error 1. Press on
SOFTWARE occurred 2. Try again
UPGRADE during N/A 3. Check USB key (change as necessary)
ERROR software 4. Contact Customer Service Department
upgrade
When logged in Biolo, Operator or Service level, it is not possible to able/disable an actioner from the “check
sensors” screen while a cycle is in progress.
The user
attempts to ACTION ON
manually THE ACTIONER 1. Press on
CYCLE BUSY
activate/de- IS NOT 2. Wait the end of the cycle in progress then
active an PERFORMED retry
actioner
Note: Adjustment process fails if the number of cells counted during the first or second counting phase are
less than
1. Press on
2. Try again
RBC RESISTIVE 3. Perform a bleach cycle
Resistive gain
GAIN Default gain is 4. Check the latex solution (polluted)
adjustment
ADJUSTMENT applied 5. Check counting head
failed
FAILED 6. Check cable and connections
7. Check CPU (change as necessary)
1. Press on
WBC 2. Try again
RESISTIVE Resistive gain 3. Perform a bleach cycle
Default gain is 4. Check the latex solution (polluted)
GAIN adjustment
applied 5. Check counting head
ADJUSTMENT failed
6. Check cable and connections
FAILED
7. Check CPU (change as necessary)
Note: The HGB adjustment fails when the LED flow cannot be adjusted within target +/- tolerance.
The DIF
Measurement
The 1. Press on
OPT LED is invalidated
adjustment of 2. Proceed to OPT LED adjustment again
ADJUSTEMENT until an
the OPT LED is 3. Verify the presence of diluent in WBC bath
FAILED adjustment of 4. Check cable and connections
failed.
the LED 5. Check optical bench
successes.
Message when during counting phase more than one sequence has a reference out of the fixed range
(Target ±10%), the following prompt is displayed
If more than
one sequence 1. Press on
GAIN has a 2. Try again
ADJUSTMENT reference out N/A 3. Check cable and connections
FAILED of the fixed 4. Check optical bench
range (Target
±10%)
Message when during counting phase, pulse count is less than 200
1. Press on
GAIN if pulse count 2. Check for tubing pinched or clogged
ADJUSTMENT in the area is N/A 3. Check for cables connections
FAILED not sufficient 4. Check for optic nozzle clogged
5. Change latex solution
6. Check for CPU (change as necessary)
2. SAMPLING PROBE MOVES TO WBC COUNTING CHAMBER AND WASTE CHAMBERS DRAINING
1 Syringe DOWN + Pump ON WBC counting chamber draining + Transfer tubing draining
9. FIRST COUNTING
STE
ACTION COMMENT
P
WBC counting chamber and transfer tubing draining,
Syringe DOWN + Pump ON +
1 sampling probe moves to rinsing position in RBC counting
Sampling probe DOWN
chamber
2 Syringe UP WBC counting chamber filling with diluent
Back flushes with cleaner for cleaning counting heads after
3 Syringe UP
counting sequences
Sequence duration: 2.5 secs, cycle duration: 55 secs
14. SAMPLING MODULE MOVES TO WBC COUNTING CHAMBER AND SAMPLING PROBE INITIALIZATION FOR
NEXT SAMPLE
1. Vacuum tank.
MISPACOUNTPLUS is equipped with an additional vacuum tank allowing to increase the quantity of vacuum
additionally to the one generated by the waste syringe. This additional reserve of vacuum is necessary to
answer to the instrument needs in matter of vacuum due to the implementation of the optical module.
2. Pump
MISPACOUNTPLUS is equipped with an additional pump increasing the efficiency of the needle rinsing.
This pump is a 24Volts membrane pump designed to support both air and liquids
The pump is installed on the rinse head fluidic circuit, on aspiration side. It is used to aspirate the diluent
pushed on the rinse head to perform to needle washing. Diluent used to clean the needle will be evacuated
to the waste container.
The vacuum generated by the pump is checked and controlled regularly during the analysis cycle.
To control the pump vacuum, the MISPACOUNTPLUS is equipped with an in-line pressure sensor connected
on the same line, checking the vacuum generated by the pump.
Rinse Pump
It is possible to check verify or control the good functionality of the MISPACOUNTPLUS pump.
Going in check sensors screen, select TEST PUMP to switch on the pump, then check the value in INLINE
PRESSURE field.
3. Heating System
To perform the five-differential optical reading, diluent and lyse reagents must to be heated.
The reason why is to increase and accelerate the action of the lyse and for that reason, MISPACOUNTPLUS
is equipped with a additional heating module.
Heating system is internally equipped with two separated fluidic circuits respectively dedicated for diluent
and lyse.
Internal diluent fluidic circuit is much longer than internal lyse fluidic circuit due to the difference of
volumes which must be heated. The Difference of volumes which must be heated come from the
difference of volumes necessary to perform the analysis.
It is possible to check verify or control the good functionality of the MISPACOUNTPLUS Heating system.
Going in check sensors screen, REAGENT TEMP field is dedicated to the display of the heater temperature.
HEAT field is dedicated to the display of the heating power in percentage (0 for the min, 100 for the max).
DILUENT TEMP field is dedicated to the display of the diluent temperature injected in WBC counting
chamber.
The following instructions will guide you to dismantle and assemble the Optic Module.
DISMANTLING INSTRUCTION
Action Step Reference
Dismantling
ASSEMBLING INSTRUCTION
Action Step Reference
#33E
#33E
#34A
#35c
#35B
ASSEMBLING INSTRUCTION
Action Step Reference
Adjustment 1. Select:
SERVICE/TECHNICIAN/ADJUST WBC
then select ADJ LED.
Adjustment 10. When the curves appear on screen, you can begin
the adjustment turning the transverse adjustment
tool on both side.
15 cNm
40 cNm
Adjustment 18. At the end of the cycle FSC and ALL gain values
are updated
Adjustment 19. Run with fresh blood and verify the good position
of the scattergram.
4. Optical module
Allowing to give 5 parts differentials of WBC, MISPACOUNTPLUS instrument is equipped with an Optical
bench.
Optical bench is composed with 3 parts, illumination, detection and flow cell.
Only the complete optical module (equipped with the optical flow cell) can be replaced on
MISPACOUNTPLUS.
It means that it is impossible to replace independently the illumination, detection and or flowcell
sub-assembly which compose the optical bench and it is obvious that it is impossible to replace
independently the different parts which compose these sub- assemblies.
These sub-assemblies are adjusted during manufacturing process with a specific adjustment
tooling which allows to adjust and control each part independently and to adjust and control the
complete module assembly.
Illumination part
LED
Detection part
Light collection.
Photo diode
Flowcell
The following instructions will guide you to dismantle and assemble all elements of the counting module.
RBC Electrode.
Tools/Material Torx tool T10
Removal
Action Steps Reference
Removal
Action Steps Reference
38
38 38
38
50cNm
Removal
Action Steps Reference
30 cNm
Removal
Action Steps Reference
Removal
Action Steps Reference
38
4 4
50cNm
Removal
Action Steps Reference
38
30 cNm
Counting Holder
Removal
Action Steps Reference
The following instruction will guide you to dismantle and assemble the heater module.
Heater replacement.
Heater dismantling.
DISMANTLING INSTRUCTION
Action Step Reference
Prerequisite 10. Drain the instrument from any 7. Remove pick up tubing’s from containers and
liquids. perform prime all.
8. Refer to the instruction.
11. Switch off the instrument and
disconnect the power supply. 9. Refer to the instruction.
12. Remove the fluidic door. 10. Refer to the instruction.
13. Remove the reagent door. 11. Refer to the instruction.
14. Remove the top cover. 12. Refer to the instruction.
15. Remove the reagent plate
Heater assembling
ASSEMBLING INSTRUCTION
Action Step Reference
100 cNm
22
11
7
The following instructions will guide you to dismantle and assemble all elements of the In Line Pressure
Sensor.
Tools/Material NA
DISMANTLING INSTRUCTION
Action Step Reference
Prerequisite 16. Switch off the instrument and disconnect the 13. Refer to the instruction.
power supply.
17. Remove the fluidic door. 14. Refer to the instruction.
18. Remove the reagent door. 15. Refer to the instruction.
19. Remove the top cover. 16. Refer to the instruction.
20. Remove the reagent plate 17. Refer to the instruction.
10C
Tools/Material NA
ASSEMBLING INSTRUCTION
Action Step Reference
10C
Pump Disassembly
The following instructions will guide you to dismantle and assemble the rinse pump.
Pump replacement.
Rinse pump dismantling.
DISMANTLING INSTRUCTION
Action Step Reference
Prerequisite 21. Switch off the instrument and disconnect the 18. Refer to the instruction.
power supply.
22. Remove the fluidic door. 19. Refer to the instruction.
23. Remove the reagent door. 20. Refer to the instruction.
24. Remove the top cover. 21. Refer to the instruction.
25. Remove the front cover. 22. Refer to the instruction.
26. Remove the reagent plate. 23. Refer to the instruction.
27. Remove the second reagent plate.
#23E #10D
ASSEMBLING INSTRUCTION
Action Step Reference
Prerequisite 4. Follow the instruction of the Rinse pump 5. Refer to the instruction.
dismantling
Assembling 34. Connect the two tubings #10C & #10B) from
the pump.
#10C #10B
#10B
Stopcock Disassembly
The following instructions will guide you to dismantle and assemble the stopcock element.
Stopcock replacement.
Stopcock dismantling.
DISMANTLING INSTRUCTION
Action Step Reference
Prerequisite 28. Switch off the instrument and 24. Refer to the instruction.
disconnect the power supply.
29. Remove the fluidic door. 25. Refer to the instruction.
30. Remove the reagent door. 26. Refer to the instruction.
31. Remove the top cover. 27. Refer to the instruction.
32. Remove the reagent plate 28. Refer to the instruction.
#3C
Stopcock assembling
ASSEMBLING INSTRUCTION
Action Step Reference
#3C
The following instructions will guide you to dismantle and assemble the ambient and reagent temperature
sensors.
DISMANTLING INSTRUCTION
Action Step Reference
Prerequisite 33. Switch off the instrument and disconnect the 29. Refer to the instruction.
power supply.
34. Remove the fluidic door. 30. Refer to the instruction.
35. Remove the reagent door. 31. Refer to the instruction.
36. Remove the top cover. 32. Refer to the instruction.
37. Remove the front cover. 33. Refer to the instruction.
38. Remove the reagent plate. 34. Refer to the instruction.
39. Remove the second reagent plate.
ASSEMBLING INSTRUCTION
Action Step Reference
150 cNm
DISMANTLING INSTRUCTION
Action Step Reference
Prerequisite 1. Switch off the instrument and disconnect the 1. Refer to the instruction.
power supply.
2. Remove the fluidic door. 2. Refer to the instruction.
3. Remove the reagent door. 3. Refer to the instruction.
4. Remove the top cover. 4. Refer to the instruction.
5. Remove the front cover. 5. Refer to the instruction.
6. Remove the reagent plate. 6. Refer to the instruction.
7. Remove the second reagent plate. 7. Refer to the instruction.
ASSEMBLING INSTRUCTION
Action Step Reference
The following instructions will guide you to dismantle and assemble the Discharge Tubing.
DISMANTLING INSTRUCTION
Action Step Reference
Prerequisite 40. Switch off the instrument and 35. Refer to the instruction.
disconnect the power supply.
41. Remove the fluidic door. 36. Refer to the instruction.
42. Remove the reagent door. 37. Refer to the instruction.
43. Remove the top cover. 38. Refer to the instruction.
44. Remove the reagent plate. 39. Refer to the instruction.
Tools/Material NA
ASSEMBLING INSTRUCTION
Action Step Reference
The following instructions will guide you to dismantle and assemble the different electronic boards.
DISMANTLING INSTRUCTION
Action Step Reference
ASSEMBLING INSTRUCTION
Action Step Reference
4. Select
SERVICE/BACKUP&RESTORE/RESTO
RE and follow the instructions 4.
displayed.
5. Select 5.
SERVICE/TECHNICIAN/ADJUST
OTHERS, enter the altitude (where
the instrument is located) in the
dedicated field and select ADJUST.
6.
6. From the same screen, using Latex
particles 7µm, perform WBC gain
adjustment pressing on ADJUST.
7.
7. From the same screen, using Latex
particles 5µm, perform RBC gain
adjustment.
8. Select 8.
SERVICE/TECHNICIAN/ADJUST
OTHERS, in the field HGB select
ADJUST.
9.
10.
10. Select
SERVICE/TECHNICIAN/ADJUST/ADJ.L
ED to perform optic LED
adjustment. 11.
12.
DISMANTLING INSTRUCTION
Action Step Reference
Prerequisite 1. Switch off the instrument and disconnect the 1. Refer to the instruction.
power supply.
2. Follow the instruction of Front Cover 2. Refer to the instruction.
Dismantling.
ASSEMBLING INSTRUCTION
Action Step Reference
Prerequisite 1. Follow the instruction of USB board 10. Refer to the instruction.
dismantling.
DISMANTLING INSTRUCTION
Action Step Reference
Prerequisite 1. Switch off the instrument and disconnect the 1. Refer to the instruction.
power supply.
2. Follow the instruction of reagent plate 2. Refer to the instruction.
dismantling.
ASSEMBLING INSTRUCTION
Action Step Reference
DISMANTLING INSTRUCTION
Action Step Reference
ASSEMBLING INSTRUCTION
Action Step Reference
15cNm
The following instructions will guide you to dismantle and assemble all elements of the sampling module.
DISMANTLING INSTRUCTION
Action Step Reference
Prerequisite 48. Switch off the instrument and 40. Refer to the instruction.
disconnect the power supply.
49. Remove the fluidic door. 41. Refer to the instruction.
50. Remove the reagent door. 42. Refer to the instruction.
51. Remove the top cover. 43. Refer to the instruction.
52. Remove the front cover. 44. Refer to the instruction.
ASSEMBLING INSTRUCTION
Action Step Reference
Torx T06
1mm
Needle base
Tools/Material NA
DISMANTLING INSTRUCTION
Action Step Reference
The following instructions will guide you to dismantle and assemble all elements of the syringe module.
DISMANTLING INSTRUCTION
Action Step Reference
Prerequisite 53. Drain the instrument from any 45. Remove pick up tubings from their
liquids. container and select REAGENT/PRIME ALL.
46. Refer to the instruction.
54. Switch off the instrument and 47. Refer to the instruction.
disconnect the power supply. 48. Refer to the instruction.
55. Remove the fluidic door. 49. Refer to the instruction.
56. Remove the reagent door. 50. Refer to the instruction.
57. Remove the reagent plate.
58. Remove the top cover.
ASSEMBLING INSTRUCTION
Action Step Reference
Prerequisite 17. Follow the instruction of Syringe 13. Refer to the instruction.
body & pistons dismantling.
.
Sampling Piston
Diluent Piston
Waste Piston
Waste Piston
Lyse Piston
Syringe Body 10. Install the assembly on the syringe
& motor holder.
Pistons
Assembling Note: Be sure all the 16 O-rings are in
well in good position before installing
the syringe body.
35cNm
60cNm
DISMANTLING INSTRUCTION
Action Step Reference
Prerequisite 1. Drain the instrument from any liquids. 1. Refer to the instruction.
2. Switch off the instrument and
disconnect the power supply. 2. Refer to the instruction.
3. Remove the fluidic door. 3. Refer to the instruction.
4. Remove the reagent door. 4. Refer to the instruction.
5. Remove the top cover. 5. Refer to the instruction.
6. Follow the instruction of Syringe body 6. Refer to the instruction.
& pistons dismantling
ASSEMBLING INSTRUCTION
Action Step Reference
20 cNm
DISMANTLING INSTRUCTION
Action Step Reference
The following instructions will guide you to dismantle and assemble counting valves module.
Removal
Action Steps Reference
Prerequisite 1. Drain the instrument from any 1. Remove pick up tubings from their
liquids. containers and select REAGENT/ PRIME
ALL.
2. Refer to the instruction.
2. Switch off the instrument and
disconnect the main power cord. 3. Refer to the instruction.
3. Remove the fluidic door. 4. Refer to the instruction.
4. Remove the reagent door. 5. Refer to the instruction.
5. Remove the top cover. 6. Refer to the instruction.
6. Remove the reagent plate.
1
2. Remove the two fixation screws (1) of
the valve solenoid.
2
4. Remove the two fixation screws (2) of 2
the valve body.
Removal
Action Steps Reference
Prerequisite 1. Drain the instrument from any 1. Remove pick up tubings from their
liquids. containers and select REAGENT/ PRIME ALL.
2. Refer to the instruction.
ASSEMBLING INSTRUCTION
Action Step Reference
Guide
O-ring
Tools/Material NA
ASSEMBLING INSTRUCTION
Action Step Reference
Probe’s
carriage
Needle base
NOTE: Notice the specific
shape of the probe base and the
carriage.
3 Rocker replacement
3.1 Rocker dismantling.
Torx T10
Tools/Material Torx T20
Cutting pliers
DISMANTLING INSTRUCTION
Action Step Reference
2 1
3 1
One Turn
ASSEMBLING INSTRUCTION
Action Step Reference
2
1
Front view
1mm
1mm
Rocker 11. Secure the two (2) screws to the TORQUE = 80 cNm
Assembling dedicated torque.
2
1
3 1
3 cNm
3 cNm
20 cNm
20 cNm
3
4
Torx T08
Tools/Material
Torx T10
Removal
Action Step Reference
Torx T08
Tools/Material Torx T10
Torx T20
Cutting pliers
Beak pliers
Removal
Action Action Action
1. Follow the instruction of Probe belt & probe 1. Refer to the instruction.
Prerequisite carriage dismantling.
Screw to the
mechanical
GOOD
BAD
NOTE: Do not overtight the screws, it could
damage the gripper of the carriage.
Gripper
Is bent
TORQUE = 80 cNm
Dismantling
Action Action Action
Assembling
Action Action Action
2
TORQUE = 80 cNm
Dismantling
Action Action Action
Assembling
Action Action Action
Prerequisite 1. Follow the instruction of the Probe stepper 2. Refer to the instruction.
motor dismantling.
Torx T10
Tools/Material Torx T20
Cutting pliers
Beak pliers
Dismantling
Action Action Action
Prerequisite 1. Switch off the instrument and disconnect the 1. Refer to the instruction.
power supply.
2. Remove the fluidic door. 2. Refer to the instruction.
3. Remove the reagent door. 3. Refer to the instruction.
4. Remove the top cover. 4. Refer to the instruction.
5. Remove the front cover. 5. Refer to the instruction.
Torx T10
Tools/Material Torx T20
Assembling
Action Action Action
2
NOTE: Do not tighten at this stage.
Torx T10
Tools/Material
Torx T20
Dismantling
Action Action Action
Prerequisite 1. Switch off the instrument and disconnect 1. Refer to the instruction.
the power supply.
2. Remove the reagent door. 2. Refer to the instruction.
3. Remove the top cover 3. Refer to the instruction.
4. Remove the Reagent plate. 4. Refer to the instruction.
Torx T10
Tools/Material
Torx T20
Assembling
Action Action Action
The following instructions will guide you to dismantle and assemble the Syringe Valves module #1.
Removal
Action Steps Reference
Prerequisite 7. Drain the instrument from any liquids. 7. Remove pick up tubings from
their containers and select
REAGENT/ PRIME ALL.
8. Switch off the instrument and disconnect the 8. Refer to the instruction.
main power cord.
9. Remove the fluidic door. 9. Refer to the instruction.
10. Remove the reagent door. 10. Refer to the instruction.
11. Remove the top cover. 11. Refer to the instruction.
12. Remove the reagent plate. 12. Refer to the instruction.
V18 V12
40cNm
5. Install the valve solenoid on the valve body.
25cNm
DISMANTLING INSTRUCTION
Action Step Reference
Prerequisite 59. Drain the instrument from any liquids. 51. Remove pick up tubings from their
containers and select REAGENT/ PRIME
ALL.
60. Switch off the instrument and disconnect the 52. Refer to the instruction.
power supply. 53. Refer to the instruction.
61. Remove the fluidic door. 54. Refer to the instruction.
62. Remove the reagent door. 55. Refer to the instruction.
63. Remove the top cover. 56. Refer to the instruction.
64. Remove the reagent plate
V18 V12
V18 V12
ASSEMBLING INSTRUCTION
Action Step Reference
Prerequisite 18. Follow the instruction of Syringe Valves 14. Refer to the instruction.
module #1 dismantling.
.
V18 V12
The following instructions will guide you to dismantle and assemble the Syringe Valves module #2.
Removal
Action Steps Reference
Prerequisite 13. Drain the instrument from any liquids. 13. Remove pick up tubings from
their containers and select
REAGENT/ PRIME ALL.
14. Switch off the instrument and disconnect the 14. Refer to the instruction.
main power cord.
15. Remove the fluidic door. 15. Refer to the instruction.
16. Remove the reagent door. 16. Refer to the instruction.
17. Remove the top cover. 17. Refer to the instruction.
18. Remove the reagent plate. 18. Refer to the instruction.
40cNm
25cNm
DISMANTLING INSTRUCTION
Action Step Reference
Prerequisite 65. Drain the instrument from any liquids. 57. Remove pick up tubings from their
containers and select REAGENT/ PRIME
ALL .
66. Switch off the instrument and disconnect the 58. Refer to the instruction.
power supply.
67. Remove the fluidic door. 59. Refer to the instruction.
68. Remove the reagent door. 60. Refer to the instruction.
69. Remove the top cover. 61. Refer to the instruction.
V6 V5
V18 V12
ASSEMBLING INSTRUCTION
Action Step Reference
Prerequisite 19. Follow the instruction of Syringe Valves 15. Refer to the instruction.
module #2.
V6 V5
The following instructions will guide you to dismantle and assemble the Syringe Valves module #3.
DISMANTLING INSTRUCTION
Action Step Reference
Prerequisite 71. Drain the instrument from any liquids. 63. Remove pick up tubings from their
containers and select REAGENT/ PRIME
ALL.
72. Switch off the instrument and disconnect the 64. Refer to the instruction.
power supply.
73. Remove the fluidic door. 65. Refer to the instruction.
74. Remove the reagent door. 66. Refer to the instruction.
75. Remove the top cover. 67. Refer to the instruction.
76. Remove the reagent plate 68. Refer to the instruction.
ASSEMBLING INSTRUCTION
Action Step Reference
Prerequisite 20. Follow the instruction of Syringe Valves 16. Refer to the instruction.
module #3.
Completion 13. Install the reagent plate. 13. Refer to the instruction.
14. Install the top cover.
15. Install the fluidic door. 14. Refer to the instruction.
16. Install the reagent door. 15. Refer to the instruction.
17. Connect the power supply and Switch on the 16. Refer to the instruction.
instrument. 17. Refer to the instruction.
18. Perform a prime all cycle. 18. Refer to the instruction.
Fluidic system
Cleaner Line.
1. Cleaner reagent is used to:
2. Cleaner Line.
4. Cleaner prime.
NOTE: Because there is no dedicated syringe for cleaner, system will use valves #8 and #10 and waste
syringe to prime the cleaner solution.
NOTE: Typically, this case is used at the end of each analysis cycle to perform a backflush into the
apertures.
V4: Aspiration of the diluent into the syringe. V18: Dispense diluent to V12.
Valve #4 is ON.
Syringe motor moves pistons up.
Diluent is pushed through V4/V5/V6/V18/V12/Rinse head.
NOTE: Typically, this case is used to wash and to rinse the needle externally.
Needle washing: (1) The diluent is pushed to the rinse head (2) at the same time vacuum is applied at the
opposite side of the rinse head (3) the needle moves from down to up.
Needle rinsing: (1) The diluent is pushed to the rinse head without vacuum applied on the opposite side.
Valve #4 ON
Valve #5 ON
Syringe motor moves pistons up.
Diluent is pushed through V4/V5/Sampling syringe/Internal needle.
NOTE: Typically, this case is used to dispense the blood into the counting chambers, to perform 1/3 of the
WBC and RBC dilution and to rinse the needle internally.
Valve #4 ON
Valve #6 ON
Syringe motor moves pistons up.
Diluent is pushed through V4/V5/V6/heating system/WBC bath.
NOTE: Typically, this case is used to perform 2/3 of the WBC dilution.
Valve #4 ON
Valve #18 ON
Syringe motor moves pistons up.
Diluent is pushed through V4/V5/V6/V18/heating system/RBC bath.
NOTE: Typically, this case is used to perform 2/3 of the RBC dilution.
Valve #4 ON
Valve #12 ON
Valve #15 ON
Syringe motor moves pistons up.
Diluent is pushed through V4/V5/V6/V18/V12/V15/Flow cell.
NOTE: Typically, this case is used to make the diluent sheath in the flow cell during optic measurement.
Valve #4 ON
Valve #12 ON
Syringe motor moves pistons up.
Diluent is pushed through V4/V5/V6/V18/V12/V15/apertures.
NOTE: Typically, this case is used to supply the fluidic located at the back of the apertures with diluent.
Valve 9 “ON”
Valve 9 “ON”
Valve 14 “ON”
Thanks to the vacuum created in waste syringes when pistons go down and valve #1 opened, the liquid
present in WBC chamber will be drained to the waste syringes.
Thanks to the vacuum created in waste syringes when pistons go down and valve #2 opened, the liquid
present in RBC chamber will be drained to the waste syringes.
Thanks to the pistons moving up and Valve#7 opened, the liquid present in waste syringe is
evacuated to the waste container.
Thanks to the pump ON and valve #3 in normal state, liquid is aspirated from rinse head and evacuated to
the waste container.
MISPACOUNTPLUS Sampling
When sampling piston moves down it allows the blood aspiration inside the needle
RBC bubbling
WBC bubbling