Mispa Count Plus User Manual V1.3.Compressed

DOC No.
ADL/TSD/MC PLUS/UM/001
DOCUMENT NAME- User manual
EQUIPMENT MODEL- Mispa Count Plus
Version- V 1.3
AGAPPE DIAGNOSTICS LTD
YOUR BEST PARTNER IN DIAGNOSTICS 1

DOC No. ADL/TSD/MC PLUS/UM/001
REVISION RECORD
REV REASON FOR THE PAGE
No. DATE REVISION AUTHOR CHANGED S/No
1 11/04/2018 JIJU VARGHESE -- 50---------
2 17/05/2018 ADD SYMBOL DISCRIPTION Jiju Varghese 152
Hand crush, Name and address,
shipment, positioning, storage
transportation, warranty, 156,159,152,
3 21/05/2018 replacement Jiju Varghese 24,17,157,158
DISRIPTION
PAGE
S/No. DIVISION/ PART DETAILS NUMBER


Contents
Chapter 1 Safety Guidance...................................................................................................................... 8

1.1 Symbols and Definitions .............................................................................................. 8
1.2 Warnings and Cautions ................................................................................................. 8
Chapter 2 General Overview ................................................................................................................. 10
2.1 Introduction ................................................................................................................ 10
2.2 Main Parts ................................................................................................................... 11
2.2.1 Front cover ....................................................................................................... 11
2.2.2 Fluidic part ....................................................................................................... 12
2.2.3 Reagent area ..................................................................................................... 13
2.2.4 Connection board ............................................................................................. 13
2.2.5 External power supply block ............................................................................ 14
2.2.6 Printer (optional)TBD ...................................................................................... 15
2.2.7 External Barcode reader (optional) .................................................................. 15
2.3 Configuration .............................................................................................................. 16
2.3.1 Standard Configuration .................................................................................... 16
2.3.2 Options ............................................................................................................. 16
Chapter 3 Installation Guidance............................................................................................................ 17
3.1 Installation Requirement............................................................................................. 17
3.1.1 location ............................................................................................................. 17
3.1.2 Installation environment ................................................................................... 17
3.2 Unpacking ................................................................................................................... 18
3.2.1 Unpacking Procedure ....................................................................................... 18
3.2.2 Visual check ................................................................................................. 18
3.3 Installation .................................................................................................................. 20
3.3.1 Electric and Hydraulic connections.................................................................. 20
3.3.2 User’s Identification..................................................................................... 25
3.3.2.1 Log in screen ......................................................................................... 25
3.3.3 Main screen ...................................................................................................... 26
3.3.4 Reagent setting ................................................................................................. 28
3.4 STARTUP .......................................................................................................................................... 33
Chapter 4. STATS.................................................................................................................................... 35
4.1 Introduction ................................................................................................................ 35
4.2 QC ............................................................................................................................... 35
4.2.1 CHANGE ......................................................................................................... 36
4.2.2 LOAD ............................................................................................................... 38
4.2.3 RESULTS ......................................................................................................... 41
4.2.5 Levey-Jennings graph ...................................................................................... 42
4.2.4 DETAILS ......................................................................................................... 43
4.3 Calibration .................................................................................................................. 44
4.3.1 CHANGE ......................................................................................................... 44
4.3.2 RESULTS ......................................................................................................... 45
4.3.2 LOAD .......................................................................................................... 50

4.4 Repeatability ............................................................................................................... 51

Chapter 5 RUN SAMPLE ........................................................................................................................ 52
5.1 Introduction ................................................................................................................ 52
5.2 RUN SAMPLE ................................................................................................... 53
5.2.1 Run Sample – Sample Information & Sampling/Analysis Mode ....................... 53
5.2.2 How to run with patient blood analysis .............................................................. 56
5.2.3 Understand Results ............................................................................................. 59
Chapter 6 Technology ........................................................................................................................... 63
6.1.1 Detection Principle WBC, RBC, PLT Counting ...................................................... 63
6.1.2 Five-part diff measurement. .................................................................................... 64
6.2 Hemoglobin Measurement ......................................................................................... 65
6.3 Leukocyte Analysis..................................................................................................... 66
6.4 Erythrocyte Analysis................................................................................................... 68
6.5 Platelet Analysis ......................................................................................................... 70
6.6 Alarms ......................................................................................................................... 73
6.6.1 General Flags.................................................................................................... 73
6.6.2 Leukocytes Flags .............................................................................................. 74
6.6.3 Erythrocyte and HGB Flags ............................................................................. 76
6.6.4 Platelet Flags .................................................................................................... 77
6.6.5 System Alerts ............................................................................................... 78
6.6.5.1 INS-T / Instrument Temperature Out Of Range ................................... 78
6.6.5.2 WBC BAL / WBC Balance................................................................... 78
6.6.5.3 WBC-CL / WBC Aperture Clog ........................................................... 78
6.6.5.4 RBC-CL / RBC Aperture Clog ............................................................. 78
6.6.5.5 O-DF / Optical Default ......................................................................... 78
6.6.5.6 SU-F / Startup Failed ............................................................................ 78
6.6.5.7 QC Not Done / QC Not Done During The Day .................................... 78
6.6.5.8 QC Failed / Last Run QC Failed ........................................................... 78
6.7 Hydraulic Description................................................................................................. 79
6.7.1 Sampling module.............................................................................................. 80
6.7.2 syringe module ................................................................................................. 80
6.7.3 Syringe valve module ....................................................................................... 80
6.7.4 counting module ............................................................................................... 80
6.7.5 Optic Bench ……………………………………………………………………………………………………..80
6.8 Software ...................................................................................................................... 81
6.8.1 Graphical User Interface .................................................................................. 81
6.8.2 Windows ........................................................................................................... 81
Chapter 7 Specifications........................................................................................................................ 82
7.1 Analytical Specifications ............................................................................................ 82
7.1.1 Linearity ........................................................................................................... 83
7.1.2 Background ...................................................................................................... 84
7.1.3 Precision ........................................................................................................... 84
7.1.4 Carry-Over ....................................................................................................... 85
7.1.5 Correlation ........................................................................................................ 86

7.2 Units............................................................................................................................ 87
7.4 Physical Specifications ............................................................................................... 88
7.4.1 Instrument Specifications ................................................................................. 88
7.4.2 Power Supply Block ......................................................................................... 89
7.5 Reagents Specifications .............................................................................................. 89
7.5.1 MISPACOUNTPLUS Diluent (DIL-5D) ......................................................... 89
7.5.2 MISPACOUNTPLUS Cyanide Free Lytic Solution (Lyse-5D) ....................... 89
7.5.3 MISPACOUNTPLUS Enzymatic Cleaning Solution (Cleaner) ...................... 90
7.6 Analytical Limitations ................................................................................................ 91
7.6.1 Interferences ..................................................................................................... 92
Chapter 8 RESULTS ................................................................................................................................ 92
8.1 Introduction ................................................................................................................ 92
8.2 RESULTS............................................................................................................ 92
8.2.1 DATE ........................................................................................................... 93
8.2.2 DETAILS ........................................................................................................ 94
Chapter 9 SERVICE................................................................................................................................. 95
9.1 Introduction ................................................................................................................ 95
9.2 SYSTEM INIT ........................................................................................................... 95
9.3 LOGS .......................................................................................................................... 96
9.3.1 Event logs ......................................................................................................... 96
9.4 ERROR LOGS ........................................................................................................... 97
9.5 BACKUP & RESTORE ............................................................................................. 98
9.5.1 BACKUP .......................................................................................................... 98
9.5.2 RESTORE ........................................................................................................ 98
9.6 SETTINGS ............................................................................................................... 100
9.6.1 LAB PARAMETERS ..................................................................................... 100
9.6.1.1 LAB PREFERENCE ................................................................................... 101
9.6.1.2 UNITS setting ........................................................................................... 1044
9.6.1.2.1 US Format & units ............................................................................ 1044
9.6.1.2.2 SI Format & units.............................................................................. 1054
9.6.1.2.3 SI MODE Format & units:.................................................................. 105
9.6.1.2.4 Japanese Format & units: .................................................................... 105
9.6.1.3 CBC Thresholds and FLAGS ...................................................................... 106
9.6.1.4 DIF Thresholds and FLAGS ....................................................................... 107
9.6.1.5 REFERENCE RANGES ............................................................................. 108
9.6.1.6 Calibration Factors ...................................................................................... 109
9.6.2 DATE/TIME ................................................................................................... 110
9.6.3 AUTOMATIC CYCLES ................................................................................ 111
9.6.4 PRINTER ....................................................................................................... 112
9.6.4.1 PRINTER SETTINGS ................................................................................ 113
9.6.4.2 PRINTER MANAGEMENT ...................................................................... 113
9.6.5 Communication .............................................................................................. 117
9.6.6 USERS MANAGEMENT.............................................................................. 119
9.6.6.1 Add .............................................................................................................. 119

9.6.6.2 Change Password ........................................................................................ 119

9.6.6.3 Remove........................................................................................................ 120
9.6.7 SOFTWARE UPDATE .................................................................................. 121
9.7 TROUBLESHOOTING ........................................................................................... 122
9.7.1 FLUIDICS CONTROL .................................................................................. 123
9.7.2 BLEACH CLEANING .................................................................................. 124
9.7.3 DRAIN BATHS.............................................................................................. 125
9.7.4 BACKFLUSH APERTURES......................................................................... 125
9.7.5 BACKFLUSH OPT.BENCH ......................................................................... 126
9.7.6 NEEDLE DISMANTLING............................................................................ 126
9.7.6.1 CHECK ROCKER ...................................................................................... 128
9.7.7 PARK MOTORS ............................................................................................ 128
9.7.8 RINSE ............................................................................................................ 128
9.7.9 CLEAN........................................................................................................... 129
9.7.9 DRAIN FOR PACK UP ................................................................................. 129
9.7.10 SYRINGE GREASING ............................................................................... 129
9.7.11 CHECK SENSORS/VALVES ...................................................................... 131
9.7.12 CHECK SYRINGE ...................................................................................... 134
9.7.13 CHECK NEEDLE ........................................................................................ 134
9.7.15 Maintenance......................................................................................................... 135
Troubleshooting .............................................................................................................. 136
9.7.16.1 Analytical problems ................................................................................... 136
9.7.16.2 Other problems........................................................................................... 136
9.7.17 Troubleshooting Messages ........................................................................... 137
Chapter 10 SHUTDOWN ..................................................................................................................... 151
Chapter 11 Instructions to pack up and Shipment…………………..……………………………………………………152
Chapter 12 SYMBOLS AND DESCRIPTION…………………………..………………………….……………………………..155
Chapter 13 Warranty…………..……………………..…………….………………….…….………………………………………….157
Chapter 14 Return Policy……..……………………..…………….……………………….………………………………………….158

Chapter 1 Safety Guidance
1.1 Symbols and Definitions
WARNING RISK OF DANGER. Indicates a procedure to be strictly respected in

order to avoid any risk for the user, damage on the instrument or on the
result’s quality.
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.
Hand Crush/Pinch Point. Chance of injury while running the machine due to
miss handling.
1.2 Warnings and Cautions

NOTE: Misuse of electrical equipment may cause electrocution, burns, fire and other hazards.
Check if the voltage setting matches the supply voltage.

Connect MISPACOUNTPLUS power supply block to a main power supply outlet with an earth
connection.
Preserve a good access to the supply outlet to be able to unplug MISPACOUNTPLUS in emergency
case.
Do not place the power supply adapter in liquid, nor put it where it could fall into liquid. If the
power supply adapter becomes wet, unplug it before touching it.
Do not use MISPACOUNTPLUS if it is not working properly, or if it has suffered any damage
(damage to the supply cord or its plug; damaged caused by dropping the power supply adapter).
Do not let the power supply adapter or its flexible cord meet surfaces which are too hot to touch.

Do not place anything on top of MISPACOUNTPLUS

Do not use MISPACOUNTPLUS where aerosol sprays are being used, or where oxygen is being
administered.
Do not use MISPACOUNTPLUS outside
Always switch off MISPACOUNTPLUS and disconnect the power adaptor before dismantling any
part.
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.
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.

Chapter 2 General Overview
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:
White blood cell parameters: Determination

Symbol Description
WBC Total Count Measured
LYM%/# Lymphocyte percent and absolute value Measured/Calculated
MON%/# Monocyte percent and absolute value Measured/Calculated
NEU%/# Neutrophil percent and absolute value Measured/Calculated
EOS%/# Eosinophil percent and absolute value Measured/Calculated
BAS%/# Basophils percent and absolute value Measured/Calculated
ALY%/#* Abnormal Lymphocyte percent and absolute value Measured/Calculated
IMM%/#* Immature Monocyte percent and absolute value Measured/Calculated
Red blood cell parameters: Determination

Symbol Description
RBC Total count Measured
HGB Hemoglobin Measured
HCT Hematocrit Calculated
MCV Mean Cell Volume Calculated
MCH Mean Cell Hemoglobin Calculated
MCHC Mean Cell Hemoglobin Concentration Calculated
RDW-CV Red Blood Cells Distribution Width-CV Calculated
RDW-SD Red Blood Cell Distribution Width-SD Calculated
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.

2.2 Main Parts

MISPACOUNTPLUS consists of the seven main parts listed below:
1. Front cover.
2. Fluidic part.
3. Reagent area.
4. Connection board.
5. External power supply block.
6. Printer (optional).
7. External Barcode reader.
2.2.1 Front cover

The front cover consists of the five elements listed below:
1. Touch screen LCD display (8.4”).

2. ON/OFF & EMERGENCY STOP button.
3. Start analysis cycle trigger.
4. USB port connection.
5. CPU board located behind the screen

2.2.2 Fluidic part

The fluidic part is located on the right side of the instrument directly accessible after opening of the
fluidic door.
The fluidic part consists of the six elements listed below:
1. Sampling module
2. Syringe module
3. Syringe valve module
4. Counting module
5. Counting valve module
6. Optic Bench
1
3
5

2.2.3 Reagent area

The reagent area is located on the left side of the instrument directly accessible after opening of the
reagent door. The reagent area is dedicated for lyse & cleaner reagent bottles.
2.2.4 Connection board

The connection board is located at the back of the instrument and allows different types of
connections described below.
4 USB Ports
TP/TCIP Port
Serial Link RS232 Port
Not Used
P/S 24V

2.2.5 External power supply block

MISPACOUNTPLUS is supplied with an external power supply block.
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.

2.2.6 Printer (optional)TBD

MISPACOUNTPLUS is not delivered with the printer. The instrument is equipped already with PCL3 &
PCL6 standard printer drivers which cover a large choose of printer models. Here below the list of
the printers compatible with the instrument.
2.2.7 External Barcode reader (optional)

An external barrcode reader can be provided as an option (Model OPTICON - C37).
Connected to an USB port of MISPACOUNTPLUS, it allows entering automatically the following fields:
 Sample identification SID.

 Reagent identification (LYSE, CLEANER and DILUENT).
 QC and calibration lot number.
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
• 1 printer with USB connection

• 1 USB Barcode scanner
• 1 USB Keyboard (QWERTY only)

Chapter 3 Installation Guidance
3.1 Installation Requirement

3.1.1 location
To ensure MISPACOUNTPLUS fulfills its function, it must be installed on strong and stable table which
supports the weight of the unit as well as the one of the printer and reagents (around 30 Kg). Ten
centimeters space at the rear of the instrument and 30 centimeters on each side are required for
maintenance tasks and reagents change.
Exposure to direct sunlight shall be avoided.
3.1.2 Installation environment

• Indoor use.
• Altitude up to 3000 meters.
• Using temperature [18 °C to 32 °C].
Note: If the ambient temperature moves more than 10°C during the working day,
MISPACOUNTPLUS must be calibrated more frequently.
• Maximum relative humidity for temperatures up to 31 °C is 80 %, decreasing linearly to 50 %

at 40 °C.
• Main power supply voltage fluctuations up to ±10 % of the nominal voltage.
• Transient over voltages typically present on the main supply.
• Rated pollution degree II.
Contact your distributor to use the MISPACOUNTPLUS in other conditions than

the ones described above.
.
Storage and transportation environment
• Ambient temperature: -10 ℃ to 40 ℃

• Relative humidity: 10 % - 93 %
• Atmospheric pressure: 70 kPa - 106 kPa

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.
3.2.2 Visual check

Open the fluidic door on the right side with the screw driver provided in the kit and check the following
items:
 Syringes pistons located in top position.
 Sampling module located on front.

 Needle rinsing dismountable system well locked on the sampling module.
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.
3.3.1 Electric and Hydraulic connections.
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.
3. Control the presence of all elements comparing to the packing list

Whether any element would be missing, contact immediately your distributor
4. Connect the diluent pickup tubing to the dedicated hydraulic connector located at the back
of the instrument.
To connect the diluent pick up tubing,

place the two hydraulic connectors face
to face and turn clockwise the one of
the diluent pickup tube
5. Connect the waste tubing to the red hydraulic connector located at the back of the
instrument.
To connect the waste tubing, place the

two hydraulic connectors face to face
and turn anticlockwise the red one 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.
8. Connect the diluent pickup tubing to the diluent container.
DILUENT CONTAINER MUST ALWAYS BE PLACED ON THE SAME LEVEL THAN THE INSTRUMENT
9. Place the waste straw into a waste container.
WASTE CONTAINER MUST ALWAYS BE PLACED ON FLOOR UNDER 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.
11. Connect the main cord to the power supply block.
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.
The instrument is now physically installed, follow the following chapters of this document to setup
all options needed for putting into operation.
14. Positioning of the instrument
Always ensure to keep 15CM gap on Left, Right and backside of the instrument
for ease of use. This position shown above is necessary to easily operate the
disconnection of the device from the supply mains and reagent loading.

3.3.2 User’s Identification

3.3.2.1 Log in screen
Regarding the first login, only two different levels of access are available, BIOLOGIST AND
SERVICE.
Thereafter, additional Operator access level could be created.
Operator level is the more limited in terms of access.
It is possible to create, change or modify Operator ID and/or associated password for Biologist
and Operator access levels only (see describtion of ADMINUSER screen).
▪ Biologist: Operator ID = BIOLO, Password = 123456

▪ Operator: To be defined in ADMINUSER screen.
If one field is empty, error

message is displayed.
If one fiedl is wrongly filled,

error message is displayed.
Enter your Operator ID and Password using the Alpha-Numeric keyboard displayed on screen.
Press on to access to the main menu.

3.3.3 Main screen
The main menu is displayed immediately after validation of the login screen.
From this screen, it is possible to access to the following sub-menus.
▪ STATS
▪ RUN SAMPLE
▪ RESULTS
▪ REAGENTS
▪ SERVICE
: Shutdown cycle must

be launched every day to switch off the
instrument.
: Start up cycle must be

launched every day after switch on the
instrument.
Note : All menus and sub-menus are displayed with the same headband as described below.
▪ : to be back to the previous sreen in the arborescence.
▪ : Depending of the screen, to get access to the following options.
To send results data to the host computer.
To make a printout.
To cancel the data.
To write on or to read from Udrive.

To escape without use.
▪ to be back to the main menu.
▪ to get access to the following software and hardware configuration status.
Note : Editable screens have following buttons:
▪ Validation button.
▪ Cancel button.
▪ Selection in tables.
Note: Table screen have following buttons.
move to the top of the table

move up in the table step by step
move down in the table step by step
move to the bottom of the table

move to the left of the table
move to the left step by step

Uncheck to unselect.
move to the
Check right of the table
to select
move to the right step by step
3.3.4 Reagent setting
Select , the following screen is displayed.
1. Select and fill in the fields Lot, Expiry, Capacity, SERIAL and CODE fields with the
indications provided on the label of diluent container.

Once fields
completed,
select to
save
modification,
the following
window is
displayed.
Select to save changes or

to cancel.
2. Select and fill in the fields Lot, Expiry, Capacity, SERIAL and CODE with the indications
provided on the label of lyse container.

Once fields completed,

select to save
modification, the
following window is
displayed

to cancel.
3. Select and fill in the fields Lot, Expiry, Capacity, SERIAL and CODE with the indications
provided on the label of cleaner container.
Once fields
completed,
select to
save
modification,
the following
window is
displayed.


to cancel.
4. Select to enter in the dedicated waste management menu
By leaving the WASTE OPEN DRAIN option unselected , the waste capacity is required. With this
configuration, the waste capacity is managed and is required to be reset when the waste level is
ALMOST FULL OR FULL.
NOTE: It is recommended to use a waste container at least from the same capacity than the
diluent one.
To Reset the waste volume:
 Select on WASTE line to reset the waste current level, the following window is
displayed.
Select to confirm, then

waste current level is reset
to 0%.
 Select in reagent screen to validate the modifications, the following window is displayed.


to cancel.
Selecting the WASTE OPEN DRAIN option removes the WASTE CAPACITY from the user interface.
In this case, the waste level is not managed. This configuration is required when the instrument is
connected to centralized waste management system.
• Select to perform a complete prime all reagents.
Be sure that all reagents and waste tubes are properly connected before
starting.
When the cycle LED turns red, no cycle can be performed before it turns back
green.
The reset of the Cycle Counter is only allowed to the Technician.

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.
NOTE: The background values do not to exceed the following levels:
WBC: 0.2
RBC: 0.02
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.

Chapter 4. STATS
4.1 Introduction
STATS menu is dedicated for Calibration, Quality Control and repeatability.
To control the stability of the instrument before running patient samples, it is mandatory to run QC
bloods from different levels at the beginning of the working day.
In case of result out of range on QC bloods, it is recommended to perform a calibration, then run QC
bloods again.
Concerning Quality Control Blood, it is strongly recommended to respect

strictly the manufacturer instructions in matter of storage temperature,
agitation and caution to use. Read carefully the supplier information provided
with.
4.2 QC
QC menu is dedicated to Quality Control of the instrument. MISPACOUNTPLUS can store in internal
memory, up to 100 results (results and histograms) per lot for 12 different lots. Results of each QC lot
and level can be viewed in tables and in Levey-Jennings graph.
It recommanded to run QC every day before patient’s analysis. If it is not

done, the message “QC not done” will appear in Flags field of the result on
screen as well as on the printed report.
If the last QC result is out of the lot limits, the message “QC FAILED” is set to
every analysis until a correct QC is done the message “ when
MISPACOUNTPLUS is configured in this way
Press STATS on the main menu, then QC, the following screen is displayed.
This screen is the table of all the existing QC already recorded in the instrument.

Available in this screen:
Select the QC lot number(s), then the

action.
Concerning the QC table of the existing QC .
• The last active lot is labeled with a dark dot on the left of lot identification.
• To choose another lot, press on the related field.
• The key CHANGE allows the modification or the creation of a new item
• The key RESULTS allows:
To view result table.
To perform quality control analysis.
4.2.1 CHANGE
This option allows the user :
To modify data of an existing QC after selection in QC table.
To create a new item of QC after selection of a free field in QC table.
In case of modification of an existing QC, all recorded results linked with this
modified control lot number will be erased.
 Enter the QC data:

• Lot number
• Level
• Expiration date
• Target values
• Limits.

1
2
3
4
Alpha-Numeric
touch screen
keyboard
Using Alpha-Numeric touch screen keyboard
1 Enter the QC Lot number.
2 Select the QC Level among the options L (low) N (normal) or H (high).
3 Enter the QC expiration date.
4 Enter target values and limits for all parameters.
Use accessing to other parameters down in the list.
Select to confirm or to cancel modifications.
In case of validation concerning

modifications of an existing QC
Warning window is displayed
Option allows to import QC data from Udrive instead of using touch screen keyboard.

4.2.2 LOAD
How to proceed to import QC from Udrive.
1. U-drive must be formatted in FAT 32.

2. Under the root, create the directory MIS
MISPACOUNTPLUS.
PAC
3. Under the directory MISPACOUNTPLUS, create a
directory QC. OU
4. Under the directory QC, place the QC files NTP
LUS
Units format must be specified in order for the system to know which unit is used
Unit;1 stands for US units.
Parameters must be specified in US units ONLY.
QC LOT must be the LOT NUMBER followed by the LEVEL as shown below.
QC_LOW QC_NORMAL QC_HIGH



4.2.3 RESULTS
This screen is dedicated to:
• See results of a QC after selection in QC table.
• Run a QC analysis, after selection in QC table.
How to run with QC.
1. select in QC table, the needle moves down in sampling position.

2. Place the control blood in sampling position.
3. Press on start cycle trigger, front LED flickers alternatively red to green, when it becomes red only,
the tube can be removed.
 Results are displayed in line in the table run after run.
 Displayed down in the screen, automatic statistical calculations are implemented
also run after run.
NOTE: concerns only the selected results ( ) in the table.
 and allow access to other parameters results.

 The column allows to select or unselect a result in the table. Automatic
statistical calculations will be implemented accordingly.

4.2.5 Levey-Jennings graph

This menu enables to display the Levey-Jennings graph for each quality control run.
 The column on the left shows each parameter with the target values and the limits.
 The value under the parameter name is the result of the QC run where the cursor is located.
o Target Cursor
• High limit
• Result
• Low limit
 The key enable displaying following pages giving access to all parameters view.
 The keys and enable displaying first or last page directly.
 The keys and enable to move the cursor from QC result to another one.
 The keys and enable to move the cursor to the first QC result or the last one directly.
 RESULT shows the number of results for the selected QC.

 DATE/HOUR gives data about date and time of the related displayed result.
Date & time for selected run number 10

4.2.4 DETAILS
This screen allows to see the detailed result of a selected QC in RESULTS table.
Note: To select a QC result in RESULTS table, press first anywhere on the QC line you want see the
detail, then select DETAIL.
QC line selected
move to the first result move to the last result
move to the previous result move to the next result

4.3 Calibration
To reach Calibration screen, press in main menu, then press

.
The following screen is displayed, providing information concerning the last calibration done:
• Lot number
• Expiry
• Date
• Operator name
• Target and ranges values for calibrated parameters
• Current coefficients from last calibration.
4.3.1 CHANGE
To enter new data or to modify existing ones, press , the following screen is displayed.

In case of modification of an existing calibration data, all linked recorded

results will be erased.
Using the Alpha-Numeric touch screen keyboard.
1 Enter the Calibrator Lot number.
23 Enter the Calibrator expiration date.
3 Enter targets and limits values for all parameters.
4
Select to confirm modification, the following window is displayed.
In case of validation concerning

modifications of an existing calibration
Question window is displayed
Press to validate new calibrator data record or to exit without saving.
4.3.2 RESULTS
This screen is dedicated to:
• See results of last Calibration.
• Run a new Calibration.

How to run with Calibration.
1. Select , following screen is displayed and sampling needle go down in sampling

position.
1. Place the tube of calibrator in the sampling position.

2. Press on start cycle trigger, front LED flickers alternatively red to green, when it becomes red only,
the tube can be removed.
3. Repeat the same operation at least three times (maximum 12).
NOTE: At least three consecutive runs are mandatory to validate the Calibration.

 Results are displayed in line in the table run after run.
 Displayed down in the screen, automatic statistical calculations are implemented

also run after run.
 The column allows to select or unselect a result in the table. Automatic

statistical calculations will be implemented accordingly.
NOTE: fields are calculated function of the selected results ( ) in the table.
In the field below, N is the selected number of results, LOT and EXPIRY information from
calibrator used.
Concerning Calibrator Blood, it is strongly recommended to respect strictly the

manufacturer instructions in matter of storage temperature, agitation and
caution to use. Read carefully the supplier information provided with.
The calibration blood must be used before its expiry date, be mixed and stored
in accordance with the instructions of use recommended by the manufacturer.

4. To calibrate press , the following window is displayed.
NOTE: If necessary, uncheck parameter(s) you do not want to calibrate.
5. Press to validate new calibration, following window is displayed.
7 Press to validate
6. Select to exit without saving.
7. Press on to restart the calibration, the following window is displayed.
select to cancel the

previous calibration data or
to exit without saving.
NOTE: To print the calibration report, press TOOLS then

Example of calibration report Print out

4.3.2 LOAD
To load calibrator data from Udrive, press on , the following screen is displayed.
How to proceed to import Calibration data from Udrive.
1. Under the directory MISPACOUNTPLUS, previously created for QC,

create the directory Cali.
2. Under the directory Cali, place the Calibration file
Units format must be specified in order for the system to know which unit is used
Unit;1 stands for US units.
Parameters must be specified in US units ONLY.

4.4 Repeatability
From main menu, press , then , the following screen is displayed

This screen allows carrying out a test of repeatability on all parameters.
How to run with Repeatability.
1. Place the sample tube in sampling position and press the start cycle trigger.
2. The cycle LED flickers alternatively red to green, when it becomes red only the tube can be
removed.
3. Repeat the operation as desired (maximum 50 runs).
4. Statistical calculations are automatically carried out with each run.
5. The column # allows to validate or to unselect a result.
6. The button allows deleting the unselected result(s).

Chapter 5 RUN SAMPLE
5.1 Introduction
1. The human blood venous sample must be collected in an EDTA K2 or K3 (Ethylene Diamine
Tetracetic Acid, bi or tri-potassic) tube in sufficient quantity.
2. It must be properly homogenized before analysis.
A volume of insufficient blood for the quantity of anticoagulant or a bad mixing

may involve an erroneous result.
If the room temperature moves more than 10°C during the working day,
MISPACOUNTPLUS must be calibrated again.
It is recommended (or mandatory per the legislation) to carry out a Quality

Control (QC) and possibly a calibration at the beginning of every working day

5.2 RUN SAMPLE
5.2.1 Run Sample – Sample Information & Sampling/Analysis Mode
1. From the main menu, press on .
2. The needle goes down in sampling position and the following screen is displayed.
3. Press NEXT SAMPLE, the following screen is displayed.
4. NAME field, to enter Patient Name (20 characters max.)
5. PID field, to enter Patient Identification (16 characters max.)
6. SID field, to enter Sample identification (16 characters max.)
7. Birth Date field, to select patient’s data.

Select successively fields day, month, year and ajust with arrows
Note It is not possible to enter a date >1900, future date or not realistic.
8. Doctor field, to enter Doctor ID.
9. Comments field, to add comments if needed.
10. Mode field, to select blood type among DIF WB for DIF whole blood mode, DIF PD for DIF pre-
diluted mode, CBC WB for CBC Whole Blood or CBC PD for CBC pre-diluted mode.
11. Gender field, to select gender among F for female, M for male or U for unknown.
12. To valid the entry and return to the previous screen, press , following screen is displayed.
13. To return to the previous screen without validation, press .

14. The mode is also accessible from the mode button localized on the RUN SAMPLE screen.
Clicking on the mode button, allow to display the following prompt:
The user can then select among the four available modes.
Once the mode is selected, the button label is updated with the following name: DIF WB, DIF PD,
CBC WB or CBC PD.
If the Pre-diluted mode is selected, the following prompt is displayed and the DIL DISPENSE
button is displayed on the RUN SAMPLE screen.

Clicking on the DIL DISPENSE button allow dispending 300µL to prepare the prediluted dilution
5.2.2 How to run with patient blood analysis
Wear rubber gloves and wash hands with a disinfectant after completion of work.
1. If the needle is not down in sampling position, press first on start cycle trigger and needle
will go down in sampling position
Start cycle trigger
2. Place the tube in order to introduce the needle two-thirds inside the blood volume and
press on start cycle trigger.

two-thirds of
the needle Blood volume
inside
NOTES:
• Front LED blinks red, meaning that tube cannot be removed.
• Tube can be removed only after the needle goes up and front LED stop blinking,Lighting red
continuously.
• A beep can be heard when the sampling has been completed
• New cycle can be started only when LED turns green again .
• As soon as the cycle is launched, the SID is incremented automatically, meaning that
MISPACOUNTPLUS is available for the next sample identification.
• Display, sending and printing of the result start few seconds before the end of the analysis
cycle.
• No need to wait the end of the printing to launch the next analysis.
3. Result is displayed on screen.

4. Down in the screen, next patient data field.

5.2.3 Understand Results

4 On left side, the field of patient identification data.
5 Down in the screen, the Flag blox field where the potential System or Morphological flags are
displayed if any
Note: If you press anywhere on System Alerts field, an enlarged window is displayed. In this
window, the messaged are displayed in longer version. For Instance, “QC Not Done” will be
displayed as “QC Not Done During The Day”.

Note: If you press anywhere on DIF Plot or histograms fields, a zoom of the one selected is
displayed.

Each parameter value is accompanied with specific information per the automaton characteristics.
Thus, additional information can be displayed on the right of the result.
• Over range on linearity high limit: Result is displayed such as XXXX +

• Over range on reportable limit: Result is displayed such as ++++
• Over range on extreme limits (user controlled): Result is displayed such as XXXX L/H
• Over range on normal limits (user controlled): Result is displayed such as XXXX l/h
• Rejected result: Result is displayed such as XXXX *
• Suspicious result is displayed such as XXXX!
• Invalid result is displayed such as ----

Example of patient result printout:

Chapter 6 Technology
6.1.1 Detection Principle WBC, RBC, PLT Counting

The counting as well as the discrimination of the cellular elements of the blood sample is based on
The Coulter Principle.
This technic is based on the modification of the impedance of a calibrated aperture soaking in an
electrolyte and going through a constant current delivered by two electrodes located on both sides of
the aperture.
A vacuum applied on a side of the aperture allows the cells passage. Cells oppose their physical volume
to the current passage. A voltage impulse is registered at the electrodes terminal. The height of this
impulse is proportional to the cell volume.

6.1.2 Five-part diff measurement.

The principle of this technology called is based on the introduction of the sample solution flow in the
flow cell with low pressure and the introduction of the diluent sheath with a high pressure. Thus, the
diluent sheath drives the sample flow straight across the cuvette through the detection area.
The main advantages are:
 High level of reliability of the optical adjustment.

 Only two measurement axes for five parameters.
 High resolution matrix.
 Low level of contamination between two measurements.
 Low Reagents consumption
Hydraulic connection
Optical Flow Cell
Flow Cell holder
Nozzle holder
Hydraulic connection
4 White blood cells

Absorbance detection
Transmitted Incident Light

LED Light flow Flow
Diffraction
detection
Absorbance
Eosinophils Neutrophils

Lymphocytes Monocytes
Diffraction
Basophils
6.2 Hemoglobin Measurement

The hemoglobin measurement is directly done in the WBC chamber, by spectrophotometry ( = 545
nm).
Hemoglobin is detected by formation of oxyhemoglobin.
HGB blank check is performed at each STARTUP cycle.
HGB Blank measurement is done also at the beginning of each analysis cycle.
By comparison of the two values, it is possible to follow potential evolution of the blank value in order
to warn the user if necessary.

6.3 Leukocyte Analysis
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.
Parameter Associated Pathologies

Leukocytosis when WBC>WBC h
WBC White Blood Cells Total count
Leucopenia when WBC<WBC l
LYM% Lymphocytes expressed in percentage Lymphocytosis when LYM # > LYM # h
LYM# Lymphocytes expressed in absolute value Lymphopenia when LYM # < LYM # l
MON% Monocytes cells expressed in percentage
Monocytosis when MON > MON h (% & #)
MON# Monocytes cells expressed in absolute value
Neutrophilia when NEU % > GRA % h
NEU% Neutrophils expressed in percentage
Neutropenia when NEU % < GRA % l
Neutrophilia when GRA # > GRA # h
NEU# Neutrophils expressed in absolute value
Neutropenia when GRA # < GRA # l
EOS% Eosinophils expressed in percentage
Eosinophila when EOS > EOS h (% & #)
EOS# Eosinophils cells expressed in absolute value
BAS% Basophils expressed in percentage
Basophilia when BAS > BAS h (%&/or #)
BAS# Basophils expressed in absolute value
IMM% Immature cells expressed in percentage
Immature Cells when IMM> IMM h (%&/or #)
IMM# Immature cells expressed in absolute value
ALY% Atypical lymph. cells expressed in percentage
Atypical Lymphocytes when ALY> ALY h(%&/or #)
ALY# Atypical lymph. expressed in absolute value

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
Lymphocytes (as well as atypical lymphocytes)

population is colored in PINK
Monocytes population is colored in BLUE
Neutrophils population is colored in GREEN (
Eosinophils population is colored in YELLOW

(#FFFF00)
Basophils population is colored in ORANGE
Immature cells population is colored in RED

6.4 Erythrocyte Analysis
The erythrocyte analysis is done by impedance metric in RBC counting chamber. Seven parameters
are obtained:
Parameters Associated Pathologies

RBC Red Blood Cells Erythrocytosis RBC > RBC h
HGB Hemoglobin Anemia HGB < HGB b
HCT Hematocrit
MCV Mean Corpuscular Volume Microcytosis VMC < VMC b
Macrocytosis VMC > VMC h
MCH Mean Corpuscular Hemoglobin
MCHC Mean Corpuscular Hemoglobin Concentration Hypochromia MCHC < MCHC b
Cold Agglutinin MCHC > MCHC h
RDW-CV Red blood cells Distribution Width (CV) Anisocytosis RDW-CV > RDW-CV h
RDW-SD Red blood cells Distribution Width (SD) Anisocytosis RDW-SD > RDW-SD h
RBC calculation is based on the pulses distribution curve.
R1 R2

 RBC histogram is displayed on result screen.

 R1 and R2 thresholds are displayed on curve in full vertical blue color
line.
 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
 Mean Corpuscular Volume (MCV) is obtained by calculation, following the formula:
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:
MCHC = HGB 100
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.

6.5 Platelet Analysis
Platelet analysis is made by impedance metric in the RBC counting chamber.

Four parameters are obtained:
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
PLT calculation is based on the pulses distribution curve.

CP1 CP2
P CP3
 PLT histogram is displayed on the result screen.

 Only P threshold is displayed in full vertical line using Blue as standard
color.
 Thrombocrit (PCT) is made from PLT and MPV by formula below:
PCT = PLT x MPV
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.
In presence of one or more alarms, it is recommended to check the result by a

conventional measure or on blood smear.
NOTE: Most of these alarms can be adjusted by the user.

6.6.1 General Flags
Each parameter value is accompanied with specific information per the automaton characteristics.
XXXX+: Over range on linearity high limit.

XXXX!: Suspicious result. This occurs when a morphological alarm has been triggered (please see
chapters below) or when an associated parameter might be suspected (For instance, if WBC if flagged
with +, LYM, MON, NEU, EOS and BAS will be flagged with +)
++++ : Higher than the reportable limits. WBC, RBC, PLT, HCT, HGB.
----: Invalid result
XXXX*: Rejected result
h: results higher than normal value.
L: results lower than normal value.
H: results higher than panic value.
L: results lower than panic value.
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 “!” is triggered display afferent result in italic (flag included)
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):
• Orange (l, h) is used as standard color

• Red (L, H) is used as standard color

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
6.6.2 Leukocytes Flags

Extraction of distribution curve in height of pulses (after initial pulse width based cut-off).
L1 L5
Two editable thresholds L1, L5 enable to discriminate the resistive count flags.
MORPHOLOGICAL ALARMS
On Curve
Trigger Condition Alarm Short version Alarm Flags enlarged
Determination of the population defined from channel CL1 Review on Smear:

to CL1-2. Small lymphocytes
The alarm is raised if this population is higher than an L1 Probable Incomplete Erytrolysis
absolute limit AND a percentage of the lymphocytes Platelet Aggregates
population. Erythroblats
Determination of the population defined by CL5 threshold
and curve ending. Review on Smear:
L5
The alarm is raised if this population is higher than an Immature Cells
absolute limit AND a percentage of the WBC population.

The measured pulses on the two optical channels are displayed on DIF Plot ALL (Y axis) Vs FSC (X
axis).
Definition of height zones enable to discriminate optic count flags.
On DIF Plot
Presence of cells in the zone in regard of Review on Smear:
the total number of leucocytes in the N1 Debris or Small Cells
DIF Plot. Platelet Aggregates
Review on Smear:
Presence of cells in the zone in regard of Probable Incomplete Erytrolysis
N2
the number of lymphocytes. Platelet Aggregates
Erythroblasts
Review the DIF
Presence of Immature Cells (from the
IMM Review on Smear:
mono or polynucleated cells line)
Immature Cells
Review the DIF
Presence of atypical lymphocytes ALY Review on Smear:
Atypical Lymphocytes
Review the DIF
Presence of atypical lymphocytes or
RL Review on Smear:
basophiles.
Right Lymphocytes
Presence of basophiles, small
Review the DIF
neutrophils (without granulations or few HL
High Lymphocytes
segmented), band cells.
Presence of small neutrophils (without
Review the DIF
granulations or few segmented), band NL
Low Neutrophils
cells or hyper basophil monocytes.
Presence of giant neutrophils, hyper
segmented neutrophils, eosinophils with Review the DIF
NH
few granulations or damaged High Neutrophils
eosinophils.

6.6.3 Erythrocyte and HGB Flags
Extraction of distribution curve in height of pulses (after initial pulse width based cut-off).
Two (2) editable thresholds R1 and R2 enable to discriminate between microcytes, normocytes and
macrocytes. CR1 CR2
100%
68.26% of total
RDW distribution area
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)
On The Curve
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.
by CR2 threshold and curve ending.
The alarm is raised if this population is R2 Macrocytes
percentage of the RBC population.

6.6.4 Platelet Flags

Extraction of distribution curve in height of pulses (after initial pulse width based cut-off), below an
editable threshold P that discriminates between PLT and RBC (sample dependent).
On The Curve
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.

by CP2 threshold and P.
The alarm is raised if this population is P2 Schizocytes
percentage of the PLT population.
by CP3 threshold and over a CP3-2 width
at the right of CP3.
P3 Microcytes
The alarm is raised if this population is
higher than an absolute limit AND a
percentage of the PLT population.
NOTE: Only P threshold is displayed on histogram.

 MPV parameter is calculated on curve distribution (defined as curve width at 20% of peak)
 PCT parameter is calculated from PLT and MPV parameters.
 P-LCR is calculated as the percentage of platelets with a volume higher than 12fL, i.e. those
appearing between 12fL and P.

 P-LCR is significantly decreased in patients with thrombocytosis while it is increased in

thrombocytopenia. In patients with high counts, P-LCR is significantly decreased in reactive
thrombocytosis than neoplastic thrombocytosis. P-LCR is more likely higher in destructive
thrombocytopenia than hypoproliferative thrombocytopenia. P-LCR is inversely related to
platelet count and directly related to PDW and MPV.
6.6.5 System Alerts

6.6.5.1 INS-T / Instrument Temperature Out Of Range
Means that the Instrument temperature is lower than 17°C or higher than 33°C and the result could
be affected.
6.6.5.2 WBC BAL / WBC Balance

Unbalanced counting between the resistive and the optical measurement on the WBC Channel. This
may be explained by a clog on the WBC aperture, a clog on the WBC flow cell or that the stop cock
has been left as closed.
6.6.5.3 WBC-CL / WBC Aperture Clog

Clog detected during WBC measurement.
6.6.5.4 RBC-CL / RBC Aperture Clog

Clog detected during RBC or PLT measurement.
6.6.5.5 O-DF / Optical Default

Unstable LED light low measurement during WBC DIF measurement. This may come from bubble or
unexpected phenomenon during WBC DIF measurement.
6.6.5.6 SU-F / Startup Failed

Background limits or HGB blank are out of range.
6.6.5.7 QC Not Done / QC Not Done During The Day

While no QC are done during the day. This system alert is set to every analysis until a QC sample is
run.
6.6.5.8 QC Failed / Last Run QC Failed

The last QC result is out of the lot limits. This system alert is set to every analysis until a correct QC is
done.

6.7 Hydraulic Description

The fluidic part is located on the right side of the instrument directly accessible after opening of the
fluidic door.
The fluidic part consists of the six elements listed below:
1. Sampling module
2. Syringe module
3. Syringe valve module
4. Counting module
5. Counting valve module
6. Optic Bench
1
3

6.7.1 Sampling module

This module (patented) allows the blood sampling and dispensing in counting chambers (WBC and
RBC) to perform appropriate dilutions.
It supports the needle and its rinse block assembly called rinse head.
The needle and its rinse head can be removed completely without tool.
The O-ring of the needle located inside the rinsing head can also be removed without tool.
The maintenance of these parts is very easy to perform please refer to the maintenance chapter to
perform it as describes.
6.7.2 syringe module

This module allows performing the aspiration/dispense of the reagents, blood’s drawing, vacuum and
positive pressure.
6.7.3 Syringe valve module

This module supports the valves allowing opening or closing the reagent and waste syringes
hydraulic circuit as well as the optic hydraulic circuit.
6.7.4 Counting module

This module allows to count the WBC and RBC/PLT and to measure the HGB.
6.7.5 Optic Bench

This module allows discriminating the 5 parts diff for WBC.
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.
6.8.1 Graphical User Interface

Common keys present in all screens:
: Allows coming back to the previous screen in the menu tree.
: 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.

: Display of current state of the instrument:
• 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
7.1 Analytical Specifications

7.1.1 Linearity
Linearity of WBC, RBC, HGB, HCT and PLT will be verified using linearity kits.
Measuring
Measurand Units* Limit Operating Range
Range
WBC 103/µL 0.2 – 100 ± 0,4 or ± 4% 0-150
0.02 – 8.0 ± 0.05 or ± 3%

RBC 106/µL 0-15
8.0 – 15 ± 0.10 or ± 4%
HGB g/dL 0.2 – 24 ± 0.2 or ± 2% 0-25
HCT % 5 – 70 ± 2 or ± 3% 0-80
MCV fL 50-150 ±2.5 or ±3.0% 50 - 150
PLT 103/µL 10 – 2000 ± 10 or ± 10% 0 - 4000
RDW-CV % 10 – 40 ± 1.5 or ± 10% 0 – 70
RDW-SD fL 15 – 150 ± 6.5 or ± 10% 0 – 220
MPV fL 5 – 25 ± 1 or ± 10% 0 – 25

MCH pg N/A N/A 0 – 99.9
MCHC g/dL N/A N/A 0 – 99.9
PCT % N/A N/A 0 – 9.999
PDW % N/A N/A 0 – 99.9
PLCR % N/A N/A 0 - 100

LYM, MONO,
NEU, EOS, BASO, 103/µL 0-100 N/A 0-150
ALY, IMM #
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
Measurand* Background Concentration Limits
WBC / DIFF < 0.2 103/µL
RBC < 0.02 106/µL
HGB < 0.2 g/dL
PLT < 10 103/µL
*Results are expressed in Standard (US) units
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)
WBC (103/µL) >6.0 < 2.5
RBC (106/µL) >3.5 < 2.0
HGB (g/dL) >11 < 1.5
MCV (fL) >80 < 1.0
HCT (%) >35 < 2.0
RDW-CV >12 < 4.0
RDW-SD >40 < 4.0
PLT(103/µL) >200 <5.0
MPV (fL) >8 <3.0
Lymphocyte (%) >15 < 5.0
Monocyte (%) >5.0 < 10
Neutrophil (%) >40 < 3.0

Eosinophil (%) >5.0 < 10
Basophil (%) >1.0 < 40
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:
Measurand Target Values % Carryover (95%

(units*) Low Target Values High Target Value Confidence Limit)
WBC /
> 0 < 0.2 >15 <1%
DIFF(103/µL)
RBC(106/µL) > 0 < 0.02 >6 <1%
HGB(g/dL) > 0 < 0.2 >20 <1%
PLT(103/µL) > 0 < 10 >300 <2%

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.
Measurand* Range Tested r-value Comparability
0.2-100 ≥0.95 N/A
WBC (103/µL) 0.2 to <2.00 N/A ±10%
2.00 to 100 N/A ±5%
RBC (106/µL) 0.02 – 7.0 ≥0.95 ±2.5%
HGB (g/dL) 0.2 -22 ≥0.95 ±2.5%
HCT (%) 15 – 60 ≥0.90 N/A
MCV (fL) 55-120 ≥0.90 ±3.0%
RDW-CV (%) >12 ≥0.60 N/A
RDW-SD ≥ 35 ≥0.60 N/A
PLT (103/µL) 10-1500 ≥0.95 N/A
MPV (fL) >7 ≥0.90 N/A
Lymphocyte (%) >15 ≥0.95 N/A
Monocyte (%) >5.0 ≥0.95 N/A
Neutrophil (%) >40 ≥0.95 N/A
Eosinophil (%) >5.0 ≥0.90 N/A
Basophil (%) >1.0 ≥0.15 N/A

7.2 Units
MISPACOUNTPLUS is multi units for hematology result.
US
Parameters SI SI MOD JAPANESE
(Standard)
WBC XXX.X XXX.X XXX.X XXXX.

103/µL 109/L 109/L 102/µL
LYM, MONO, NEU, EOS, BASO, ALY, IMM # XXX.X XXX.X XXX.X XXX
103/µL 109/L 109/L 102/µL
LYM, MONO, NEU, EOS, BASO, ALY, IMM % XX.X XX.X XX.X XX.X
% % % %
RBC XX.XX XX.XX XX.XX XXXX
106/µL 1012/L 1012/L 104/µL
HGB XX.X XXX XX.XX XX.X
g/dL g/L mmol/L g/dL
HCT XX.X X.XXX X.XXX XX.X
% L/L L/L %
MCV XXX.X XXX.X XXX.X XXX.X
fL fL fL fL
MCH XX.X XX.X X.XX XX.X
pg pg fmol pg
MCHC XX.X XXX XX.XX XX.X
g/dL g/L mmol/L g/dL
RDW CV XX.X XX.X XX.X XX.X
% % % %
RDW SD XXX,X XXX,X XXX,X XXX,X
fl fl fl fl
PLT XXXX XXXX XXXX
XXX.X 104/µL
103/µL 109/L 109/L
MPV XX.X XX.X XX.X XX.X
fL fL fL fL
PCT X.XXX X.XXX X.XXX X.XXX
% cL/L cL/L %
PDW XX.X XX.X XX.X XX.X
% % % %
P-LCR XX.X XX.X XX.X XX.X
% % % %

 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
7.4 Physical Specifications

General:
Ambient temperature: from 18 to 32°C
Relative Humidity: 80% maximum at 32°C
Storage temperature: -10 to 50°C
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

7.4.2 Power Supply Block

MISPACOUNTPLUS is equipped with an external Power Supply block
• Dimensions: Height: 31 mm (approx.)

• Width: 58,5 mm (approx.)
• Depth: 132 mm (approx.)
• Weight: 0,35 kg (approx.)
• Power supply Input: 100 to 240V AC - 1,5A, 50-60Hz
7.5 Reagents Specifications

All the reagents must be stored at temperature stated on their labels.
If the reagent has been stored at a temperature less than 10°C, it must stay at
room temperature during 24 hours before use.
7.5.1 MISPACOUNTPLUS Diluent (DIL-5D)

Shelf life: 3-years closed shelf life and 60-days open shelf life
Application: MISPACOUNTPLUS Diluent is used to carry out the necessary dilutions for the
measurement performed by MISPACOUNTPLUS
Description: Clear and odorless aqueous solution.
Storage: Between 2°C and 30°C, until the expiration date printed on the container label.
Precautions: Avoid contact of the preparation with skin and eyes. Wear protective gloves and
glasses. For detailed precautions please refer to relevant Material Safety Data Sheet.
7.5.2 MISPACOUNTPLUS Cyanide Free Lytic Solution (Lyse-5D)

Application: MISPACOUNTPLUS Cyanide Free Lytic solution is used in Lyse of the red blood cells and
the leukocytes differentiation during the measurement performed on MISPACOUNTPLUS.
Storage: At temperature between 2°C and 25°C, until the expiration date printed on the bottle label.
glasses. For detailed precautions please refer to relevant Material Safety Data Sheet.

7.5.3 MISPACOUNTPLUS Enzymatic Cleaning Solution (Cleaner)

Enzymatic Cleaning Solution is used to carry out the cleaning of the measurement
system and hydraulic circuit.
Description: Odorless, blue color.
Storage: At temperature between 2°C and 30°C, until the expiry date printed on the bottle label.
glasses. For
detailed precautions please refer to relevant Material Safety Data Sheet.
First emergency care:

After exposure by respiratory tract: Supply fresh air, consult doctor in case of
symptoms.
After skin contamination: Wash off with large amount of water. Take off
contaminated clothing.
After contamination of eyes: Rinse with large amount of water for at least 15
minutes. Consult a doctor.
After consumption: Give the sufferer a lot of water to drink.
If the sufferer feels unwell, consult a doctor / ambulance.
For detailed first aid measures please refer to relevant Material Safety Data Sheet.
7.6 Analytical Limitations

MAINTENANCE Recommendations: Please respect the maintenance procedure and the quality
control procedure. Otherwise, results can be affected.
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
Parameter Specimen Possible Indication of Error

Cold Agglutinin (+) ↑MCV, ↓HCT, red cell clumping on smear
Nucleated RBC (+) NRBC on smear
WBC Cryoglobulins (+)
Platelet aggregation (+) Platelet aggregates on smear
Erythroblastosis (+) Erythroblasts on smear
Cold Agglutinin (-) ↑MCV, ↓HCT, red cell clumping on smear
Severe Microcytosis (-) Elevation of WBC
RBC
Fragmented RBC (-)
Leukocytosis (>100,000/µL) (+)
Leukocytosis(>100,000/µL) (+) Elevation of WBC
Lipemia (+) ↑MCHC, “milky” appearance of plasma
HGB
Abnormal Protein (+) ↑MCHC, Lysed Hgb/WBC sample turns
cloudy
Cold Agglutinin (-) ↑MCV, ↓HCT, red cell clumping on smear
Leukocytosis(>100,000/µL) (+) Elevation of WBC
HCT
Abnormal Red Cell Fragility (?)
Spherocytosis (?) ↓MCV, spherocytes on smear
Pseudothrombocytopenia (-) Platelet Satellitism on smear
Platelet Aggregation (-) Platelet Aggregates on smear
PLT Increased Microcytosis (+) ↓MCV
Megalocytic Platelets (-)
(+): Instrument count is affected by an increase in the result.

(-): Instrument count is affected by a decrease in the result.
(?): Instrument count is affected by either an increase or decrease in the result which is sample
dependent.

Chapter 8 RESULTS
8.1 Introduction
MISPACOUNTPLUS can save in internal memory up to 35 000 patient reports with results and
histograms.
Here below explanations how to use results area to search, print, send, save or erase results.
8.2 RESULTS
Press on main menu, the following screen is displayed.
Select by ALL or by
Sequences
Select the option desired
among the available
options.
All parameters are listed in first column, results of first tube of the day in second column, results of
second tube of the day in third column, etc…
The keys and allow moving from first to last page of results of the day.
The keys and allow moving from a patient file to another one.
The keys and allow moving from beginning to the end of the list of parameters.
The keys and allow moving from a parameter to another one.

The field under the table, describes the NAME, PID, SID, Seq number, birth date, gender, mode, date
& time of the selected patient file.
To select a result in the table, select the corresponding column, result will appear in reverse video.
8.2.1 DATE
This option allows searching a patient file(s).
1. Select the year in first column on the left.
2. Select the month in the second column.
3. Select the day in the last column on the right.
• Select to access to a general view of the selected day.

• Select to get the detailed view of the selected patient file.

Once in detailed view, use the keys moving in detailed views as the same way
than on results table view.
Select to be back in results table view.
8.2.2 DETAILS
This option allows from, results table, displaying the detailed view of the patient file selected.
• Select to be back in results table

Chapter 9 SERVICE
9.1 Introduction
From the main menu, select , the following screen is displayed.
No Available in this screen:
9.2 SYSTEM INIT

This option allows performing a mechanic initialization of all the modules.
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.
9.3.1 Event logs

This option allows displaying the EVENT logs of the instrument.
EVENTS are the most important actions performed or requested by the instrument’s user.
Among EVENTS lists, the user can find: WASTE IS RESET, WASTE SET AS OPEN DRAIN, PRIME ALL
CYCLE REQUESTED, STARTUP STARTS, ….
For each EVENT, the Date, Time, Operator, Event Type and Event description is recorded.

9.4 ERROR LOGS

This option allows to display the error logs of the instrument.
Each occurrence of ERROR message window will be recorded in this file.
Among ERRORS lists, the user can find: PLEASE REPLACE DILUENT, PLEASE REPLACE DILUENT, ….
For each ERROR, the Date, Time, Operator, Event Type and Event description is recorded.

9.5 BACKUP & RESTORE

This option allows to backup and/or to restore the patients result (.csv format) the set up and
adjustments.
9.5.1 BACKUP
In BACKUP field, check the options you want backup “Data and Setup” and/or “.csv file” then select
.
The following window is displayed.
Connect an USB drive then press to confirm the backup.
9.5.2 RESTORE
In restore field, press on , the following window is displayed.

Connect an USB drive then press to confirm the restoration.
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.
9.6.1 LAB PARAMETERS

This menu allows to access to set-up options as described below.

9.6.1.1 LAB PREFERENCE

 DIF DISPLAY FORMAT

Select the option desired for the DIFF result format among:
 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 SETTING

This screen gives the possibility to the user to choose the units among the following list
9.6.1.2.1 US Format & units

9.6.1.2.2 SI Format & units
9.6.1.2.3 SI MODE Format & units:
9.6.1.2.4 Japanese Format & units:
 Select the model of unit you want use then press to valid, the following window is

displayed.
 press to save change or to cancel.
9.6.1.3 CBC THRESHOLDS AND FLAGS

This menu allows to modify the thresholds and Flags for each CBC parameters.
No Available in this screen
Thresholds modification can affect the quality of the results or can affect the
alarm detection. We recommend to modify these values only after training.

9.6.1.4 DIF THRESHOLDS AND FLAGS

This menu allows to modify the thresholds and Flags for each DIF parameters.
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.

9.6.1.5 REFERENCE RANGES

This menu allows modifying the existing values of normal and panic limits values for all parameters.
1. allows displaying the CBC

parameters.
2. allows displaying the DIF
parameters.
3. allows coming back to the
default values.
Once modifications are done, press to validate or to exit without any modification.
Following window is displayed

9.6.1.6 Calibration Factors

This menu allows modifying the calibration factors manually without to redo the complete
calibration.
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
This menu is dedicated to modify the Date /Time Setting

 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.
9.6.3 AUTOMATIC CYCLES

This menu is dedicated to set the different automatic cycle.
 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.
9.6.4 PRINTER
This menu is dedicated to set the different possible printing options.

9.6.4.1 PRINTER SETTINGS

This screen is dedicated to the printing option settings.
Select , 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.
 Auto Print: Options selected will be automatically printed.
 Control Report Options: Allows to select LMG format, percentage or absolute value for all
analysis and not only for control.
 Printer Selection: Allows to select the printer and paper size.
 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.
• Press on printer name’s field, the following window is displayed.

• Press , the following window is displayed.
• Select the field corresponding to the printer connected then press .
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.
Previously not installed

• Go back to and select the type of printer in Printer Selection field.
• Press to valid, the following window is displayed.
• Press to save changes the printer is 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.

9.6.6 USERS MANAGEMENT
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.
9.6.6.2 Change Password

Select to change the password of the selected user and fill in the different fields.

9.6.6.3 Remove
Select to delete the selected user, the following window is displayed.
press to validate or to exit without modification.
Note: at least one Biologist id must stay in the list.

9.6.7 SOFTWARE UPDATE

This option allows to update the software when necessary.
Select , 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.
 Select to valid the software update, 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:

9.7.1 FLUIDICS CONTROL

option allows performing a complete control cycle of the mechanic and the
fluidic of the instrument in case of needs. A control bar indicates the progress of the cycle
NOTE: Control cycle allows to control mechanic, hydraulic and electric functions to completely
reinitialize the instrument when it is needed.
Example of need: In case of mechanical or hydraulic problem, immediately press on button,

MISPACOUNTPLUS will perform an emergency stop. After having identified and fixed the problem, it
is necessary to perform a Control cycle to reinitialize the instrument mechanically and hydraulically.
When control cycle is finished, the following window is displayed

9.7.2 BLEACH CLEANING

option allows performing a concentrate cleaning cycle using Sodium Hypo
chloride solution*
Hypo chloride solution*: The recommended concentration of Hypo chloride

solution is 12°.
NOTE: In normal conditions, it is recommended to perform bleach cycle one time a week for a
daily workload of 50 analyses. Bleach cycle can be performed also in case of permanent rejection
for one or few measured parameters. Follow the instruction below for bleaching.
1. Press on button, the following.
 Select to confirm, the following window is displayed.
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.
9.7.3 DRAIN BATHS
option allows draining the two counting chambers in case of needs.
The following window indicates the progress of the cycle.
NOTE: This option is principally used by field FSE in case of parts replacement which does not
require a complete instrument draining.
9.7.4 BACKFLUSH APERTURES
option allows to perform a backflush onto the apertures* in case of needs.
*backflush onto the apertures: The system push cleaner under pressure into the WBC and RBC
apertures to remove a potential clogging. It can be used in case of permanent rejection for one or
few measured parameters.

9.7.5 BACKFLUSH OPT.BENCH
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.
9.7.6 NEEDLE DISMANTLING
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.
1. Press , the system moves the Sampling module in “Needle

Disassembling position” and the following window is displayed.
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.
4. Pull up the needle to remove it from the rinsing head. Disconnect it from tubing and
remove it from the instrument.
5. If needed, replace the needle following the reverse instruction.
Wear rubber gloves and wash hands with a disinfectant after completion of
work.

9.7.6.1 CHECK ROCKER
option allows controlling the functionality of the sampling module transversal

axis; it checks the motor and sensors.
9.7.7 PARK MOTORS
option allows to place the syringe pistons into the maximum high position.
NOTE: This option is Mainly used for instrument transportation.
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.
9.7.9 DRAIN FOR PACK UP
option allows performing a complete cleaning of the instrument. This

procedure includes cleaning MISPACOUNTPLUS with Bleach/P5, then rinsing with distilled water and
drying.
NOTE: This option must be always used before a long term shut down.
9.7.10 SYRINGE GREASING
: This option allows moving the pistons down in order to perform the greasing.
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.
 Hereafter the instruction to perform the pistons greasing.
1. Press on and wait for the following information window.
2. Wear rubber glove on one hand and place a bit of silicon grease at the tip of the index.

3. Spread a thin film of grease on each piston excepted sampling piston.
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.

9.7.11 CHECK SENSORS/VALVES
: This option is a control panel of all the sensors of the instrument.
 HOMES STATES
means the module is not at the

initialization position, home sensor is
not detected.
means the module is at the home

position, home sensor is detected.
 SWITCHS
means the start analysis trigger is

not activated.
means the fluidic door is closed.
 COUNT

 THERMAL
Value of vacuum/pressure measured in waste

chambers
Value of the vacuum generated by the rinse

pump
Diluent Temperature (measured by diluent t°

sensor)
Reagent temperature measured by heater t°

sensor
Instrument temperature
Percentage of heating (from 0 to 100%)
 VALVES

To test each valve, press the dedicated

button.
To test all the valves, press ALL EV ON.
To test the valves one by one, press EV
CHASER.
 CHECK DEVICE

: This function allows switching ON/OFF optic LED.
: This function allows switching ON the apertures current.
: This function allows switching ON/OFF the Hemoglobin LED.
: This function allows controlling the vacuum.
: This function allows switching ON/OFF the rinse pump.
9.7.12 CHECK SYRINGE
option allows controlling the syringe module functionality, this function checks
the syringe motor and sensor.
9.7.13 CHECK NEEDLE
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
9.7.16.1 Analytical problems
PARAMETERS PROBLEMS CONDITIONS SOLUTIONS

No results No HGB Check the HGB LED wires.
Check the electrode wires.
WBC No results HGB OK Perform a Cleaning Cycle and then a Bleach cycle if
unsuccessful.
Perform a Back flush and a Cleaning Cycle and then a
Bad
Bleach cycle if unsuccessful.
stability
Check if bubbles in WBC bath during the analysis cycle.
Check the electrode wires.
No HCT nor
No results Perform a Cleaning Cycle and then a Bleach cycle if
PLT
unsuccessful.
RBC Perform a Back flush and a Cleaning Cycle and then a
Bleach cycle if unsuccessful.
Bad
HCT & PLT too Check if bubbles in RBC bath during the analysis cycle.
stability
Check the level of bubbles in WBC bath during the first
dilution.
No results Check if the GHB LED is lighted on.
Check the level bubble flow in the WBC lath during the run
Bad
cycle.
HGB stability
Change Lyse reagent
---
Rejection Perform a new Start Up cycle.
*
9.7.16.2 Other problems
ORIGIN PROBLEMS SOLUTIONS

Check the rinsing needle block (presence of clots) and clean
Diluent leaks around the needle
it if necessary
during the run cycle
Check the rinse pump
Instrument Check the power supply connection wires.
No starting
Check the Power Supply block
Check the level of diluent and if the supply tubing is not
pinched.
All results bad
Verify if the diluent container is well located placed at the
same level than MISPACOUNTPLUS
No display Check the screen wires connection on CPU boardflat cable.
Check the paper.
Printer No printing
Check the electrical connection.

9.7.17 Troubleshooting Messages

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.
Messages Description Action/Troubleshooting
System detected Optical stop cock as closed. Open the stop cock if it’s closed.
Check that the optical bench isn’t fouled up.
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 detect a Reagent temperature Check the heater.

overflow. (Reagent temperature > 60°C). Reboot the automaton.
System detected an efficiency failure in Check the heater.

the Heating system. (heating without Reboot the automaton.
temperature rising during 2 minutes).

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.
Note: Auto Clean frequency is adjustable in

SETTINGS/OTHERS screen.
Appears when trying to run a cycle after an

Press on and perform a control cycle.
emergency stop.
Control cycle is mandatory after emergency stop.
Trying to run a cycle while another one is in

Press on and wait the end of the cycle in
progress.
progress before to run another cycle.
Cycle stopped upon user request (emergency stop

Press on and perform a control cycle.
button).
Press on to cancel the message.

Vacuum failure during bath draining
1. RBC/PLT bath is not drained:

• Perform VACUUM TEST then verify
the value (410 mb +/-5%) and the
stability of the vacuum.
• Check tub #2 and #14 (clogged,
pinched or disconnected).

• Check valve #2 (clogged or

damaged).
2. WBC bath is not drain:

• Perform VACUUM TEST then verify
• Check tub #1 and #14 (clogged,
pinched or disconnected).
• Check valve #1 (clogged or
damaged)
3. RBC/PLT and WBC baths are not

drained:
• Perform a VACUUM TEST; verify the
value (410 mb +/-5%) and the
• Check tub #14 (clogged or pinched).
• If the vacuum is close to “0”, check
Valve #8 functionality, check
tub#5;18;19;24:29 (bad connection
or disconnected).
Vacuum stability check failed during syringe

vacuum
Perform VACUUM TEST then verify the value (410
mb +/-5%) and the stability of the vacuum.
Vacuum failure during the needle rinsing.

1. Perform VACUUM TEST then verify

2. Check tub #10 (pinched or clogged).
3. Check if diluent comes properly to
rinsing head.
4. Check if needle O-ring damaged.
5. Check if needle guide released.

6. Check valve #3 (clogged or

damaged).
Vacuum failure at the beginning of bath draining

1. Verify diluent comes to the baths.

3. Verify valve #1; #2 (do not close
properly).
Vacuum failure during counting phase in analysis

Press on to cancel the message
cycle.
Pressure failure during waste syringe draining.

Press on to cancel the message

3. Check valve #7 (clogged or
damaged).
System detects waste container full.

Press on , empty the waste container and reset
waste level in reagent menu.
Note: Waste container capacity is adjusted in

reagent menu.
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.
The system detected HGB command error just after

Press on to cancel the window.
switching ON the instrument.
1. Check the HGB cable connection on

Note: When this error occurs the HGB LED is not
HGB board.
lighted ON. 2. Check the HGB cable connection on
CPU board.
3. Replace the HGB board.
4. Replace the CPU board.

Motors initialization is not done. Press on to cancel the window.
Perform motors initialization.

Ex: Instrument was switched ON with fluidic
door opened.
Steps lost on the needle motor. Press on to cancel the window.
1. Check if mechanical hard point on

needle axis.
2. Check if needle bent.
3. Check the needle belt tension.
4. Check O-ring in rinsing head.
Needle cannot join its home Press on to cancel the window.
1. Bad connection on needle sensor

wiring.
2. Needle sensor is damaged.
3. Bad connection on needle motor
wiring.
4. Needle motor is damaged.
5. Mechanical hard point on needle axis
which prevents the needle to reach
the home pos.
Needle not in home position detected before Press on to cancel the window.
to perform cycle.
Perform a motor initialization.
Home needle detection error Press on to cancel the window.

Perform motor init.
If the issue occurs again, change the sensor.
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.
Steps loss on the sampling X axis. Press on to cancel the window.
1. Check if mechanical hard point on X

axis.
2. Perform greasing of the worm wheel.
3. Check for damaged part cramping
sampling X axis to move freely.
Home sampling X axis detection error Press on to cancel the window.
Perform motor initialization.

Start-up cycle mandatory after shutdown. Press on and perform Start-up cycle.
Steps loss on the Syringe motor Press on to cancel the window.
1. Perform greasing of the worm wheel.

2. Perform pistons greasing.
3. Check if tub pinched on Syringe.
4. Check if valve do not open or clogged
on syringe.
syringe module.
6. Verify if syringe motor damaged.
Syringe can’t join its home Press on to cancel the window.
1. Bad connection on syringe sensor

wiring.
2. Syringe sensor is damaged.
3. Bad connection on syringe motor
wiring.
4. Syringe motor is damaged.
5. Mechanical hard point on syringe axis
which prevents the needle to reach
the home pos.
Home syringe detection error Press on to cancel the window.
Perform motor init.

System detects there’s no bleach during Press on and perform motor init.
bleach cycle.
Redo bleach cycle adding bleach when system
require.
Steps loss on the Waste motor Press on to cancel the window.
1. Perform greasing of the wormwheel.

2. Perform pistons greasing.
3. Check if tub pinched on Waste
Syringe.
4. Check if valve do not open or clogged
on waste syringe.
waste syringe module.
Verify if waste syringe motor damaged.
Waste cannot join its home Press on to cancel the window.
1. Bad connection on waste syringe

sensor wiring.
2. Waste syringe sensor is damaged.
3. Bad connection on waste syringe
motor wiring.
4. Waste syringe motor is damaged.
5. Mechanical hard point on waste
syringe axis cramping waste syringe
to reach the home pos.
Home waste syringe detection error Press on to cancel the window.
Perform motor init.

System detected a command error of valve 1. 1. Verify all connections concerning

valve 1 (valve and CPU connectors).
2. Verify electrical continuity on the two
cables of the valve 1.
3. Replace valve 1.

6. Replace valve 2.

3. Replace valve 3.

3. Replace valve 4.

3. Replace valve 5
1. Verify all connections concerning


System detected a command error of valve 6. 2. Verify electrical continuity on the two
Replace valve 6.

3. Replace valve 7.

4. Replace valve 8.

4. Replace valve 9.
System detected a command error of valve 1. Verify all connections concerning

10. valve 10 (valve and CPU connectors).
3. Replace valve 10.
System detected a command error of valve 1. Verify all connections concerning

11. valve 11 (valve and CPU connectors).
3. Replace valve 11.
1. Redo a second startup.

2. Perform bleach cycle.

System detected a background value out of 3. Troubleshoot on the high background

range on one or few measured parameters. of the concerned parameter.
System detected start up cycle was not done. Run START UP cycle.
System detected cleaner reagent bottle out of Replace cleaner reagent.

date after opening.
System detected lyse bottle is empty. Change lyse reagent bottle.
System detected lot number already used Redo using another lot number
System detected cleaner bottle is empty Change cleaner bottle.

System detected lyse reagent bottle out of Change lyse bottle.

date after opening.
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 diluent bottle is empty. Change diluent bottle.
System detected default during reagent data Correct the default entering good data
recording

System detected diluent reagent bottle out of Change diluent bottle.

date after opening.
System detected Cleaner bottle almost You still can perform ten analysis then system will
empty 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 .
2. The following progress bar will be displayed.
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 during three hours
every 24 hours.

Chapter 11 Instructions to pack up and Shipment

This instruction describes the different stages to follow for the packing and shifting of
MISPACOUNTPLUS instrument.
10.1.1 DRAIN FOR PACK UP
option allows performing a complete cleaning of the instrument. This

procedure includes cleaning MISPACOUNTPLUS with Bleach/P5, then rinsing with distilled water and
drying.
10.1.1 Removal of Electric and Hydraulic connections.
1. Remove power connection
2. Remove the diluent pickup tubing from the dedicated hydraulic connector located at the back
of the instrument.
To disconnect the diluent

pick up tubing, place the
two hydraulic connectors
face to face and turn anti
clockwise

3. Disconnect the waste tubing from the red hydraulic connector located at the back of the
instrument
To dis connect the waste tubing, place

the two hydraulic connectors face to
face and turn clockwise the red one of
the instruments
4. Loosen the cap of the Lyse pickup tubing (Yellow color sleeve) and the cap of the
Cleaner pickup tubing (Blue sleeve) to the dedicated bottles.
5. Disconnect the diluent pickup tubing from the diluent container.

6. Control the presence of all elements comparing to the Unpacking check list
and keep inside the Box
7. Pack the elements and place the accessories boxes to the reagent
compartment
8. Place the instrument inside the cardboard with packing foam and seal it.

Chapter 12 SYMBOLS AND DESCRIPTION
No. Symbol Description
1. Consult instructions for use
Biohazard
2. (Background color-yellow; symbol and outline-
black)
3. Recycle
4. On/Off button
5. Network port
6. Serial port
7. USB (Universal Serial Bus) connection
8. In vitro diagnostic device
Indicates that the device should be sent to special

9. agencies according to local regulations for separate
collection after its useful life.
10. Manufacturer
11. Date of manufacture
12. Temperature limits
13. Use by
14. Serial number
Caution: Federal (U.S.) Law restricts this device to

15.
sale by or on the order of a physician.

16. Equipotential grounding
17. Current: Direct(DC)
Warning
18 (Background: yellow
Symbol and outline: black)
19 Batch code
20 Hand Crush/Pinch Point
21 Caution! this symbol is used on the product in order to

find out the nature of the potential HAZARD and any
actions which have to be taken.
The symbol indicates that the device complies with the
22 European Council Directive 98/79/EC concerning
medical devices.
23 Keep the packages away from rain or damp
24 Fragile. Handle with care
25 Do not tilt or rotate
26 This way UP
27 Stack limit. Maximum stack limit is 2 same boxes

Chapter 13 Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,

EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY
OR FITNESS FOR ANY PARTICULAR PURPOSE.
Exemptions
Agappe 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 use of parts or
accessories not approved by Agappe or repairs by people other than Agappe
authorized personnel.
This warranty shall not extend to:
❑ any Agappe product which has been subjected to misuse, negligence or

accident;
❑ any Agappe product from which Agappe original serial number tag or product
identification markings have been altered or removed;
❑ any product of any other manufacturer.

Chapter 14 Return Policy
Spare Return Procedure
If it becomes necessary to return any parts of this product to Agappe, the following
procedure should be followed:
1. Obtain return material authorization(RMA): Contact the Agappe Service

engineer and obtain a Customer Support (Agappe) complaint registration
number. The Agappe number must appear on the outside of the shipping
container. Returned shipments will not be accepted if the RMA is not clearly
visible. provide the model number, serial number, and a brief description of the
reason for return;
2. Freight policy: The customer is responsible for freight charges when this product
is shipped to Agappe for service (this includes customs charges);
3. Return address: Please send the part(s) to the address offered by Customer
Service department.

Chapter 15 CONTACT INFORMATION

If you have any question about maintenance, technical speciation or malfunctioning or devices,
contact our Toll-free number: 1800-425-7151
Alternatively, you can send an email to customersupport@agappe.in
CORPORATE OFFICE
AGAPPE DIAGNOSTICS LTD,
Agappe Hills,
Pattimattom (PO), Dist. Ernakulam,
Kerala - 683 562, India.
Tel : + 91 484 2867000
Fax : + 91 484 2867222
Toll-free :1800-425-7151
Email : customersupport@agappe.in
GLOBAL ACCESS POINT

AGAPPE DIAGNOSTICS SWITZERLAND GmbH
Knonauerstrasse 54 - 6330 Cham
Switzerland
Email : customersupport@agappe.in

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DOC No.

DOCUMENT NAME- User manual

EQUIPMENT MODEL- Mispa Count Plus

AGAPPE DIAGNOSTICS LTD

YOUR BEST PARTNER IN DIAGNOSTICS 1

AGAPPE DIAGNOSTICS LTD

YOUR BEST PARTNER IN DIAGNOSTICS 2

AGAPPE DIAGNOSTICS LTD

YOUR BEST PARTNER IN DIAGNOSTICS 3

Chapter 1 Safety Guidance...................................................................................................................... 8

AGAPPE DIAGNOSTICS LTD

YOUR BEST PARTNER IN DIAGNOSTICS 4

4.4 Repeatability ............................................................................................................... 51

YOUR BEST PARTNER IN DIAGNOSTICS 5

YOUR BEST PARTNER IN DIAGNOSTICS 6

9.6.6.2 Change Password ........................................................................................ 119

AGAPPE DIAGNOSTICS LTD

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Chapter 1 Safety Guidance

1.1 Symbols and Definitions

WARNING RISK OF DANGER. Indicates a procedure to be strictly respected in

Indicates that wearing gloves is mandatory before performing the described

1.2 Warnings and Cautions

Check if the voltage setting matches the supply voltage.

AGAPPE DIAGNOSTICS LTD

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Do not place anything on top of MISPACOUNTPLUS

NOTE: MISPACOUNTPLUS is an automated hematology analyzer for in vitro diagnostic use in

AGAPPE DIAGNOSTICS LTD

YOUR BEST PARTNER IN DIAGNOSTICS 9

Chapter 2 General Overview

White blood cell parameters: Determination

Red blood cell parameters: Determination

Platelet parameters: Determination

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2.2 Main Parts

2.2.1 Front cover

1. Touch screen LCD display (8.4”).

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2.2.2 Fluidic part

YOUR BEST PARTNER IN DIAGNOSTICS 12

2.2.3 Reagent area

2.2.4 Connection board

Serial Link RS232 Port

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2.2.5 External power supply block

In the case of replacement of the main power cord supplied with

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2.2.6 Printer (optional)TBD

2.2.7 External Barcode reader (optional)

 Sample identification SID.

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2.3.1 Standard Configuration

• 1 printer with USB connection

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Chapter 3 Installation Guidance

3.1 Installation Requirement