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pocH-100i V Diff
Instructions for Use
CHAPTER1:
Introduction
Initial Operation
CHAPTER6: Operation
CHAPTER7:
Sample Analysis
CHAPTER8:
CHAPTER9:
Output
SYSMEX CORPORATION
KOBE, JAPAN
Copyright 2005-2006 by SYSMEX CORPORATION
All rights reserved. No part of this Instructions for Use may be
reproduced in any form or by any means whatsoever without
prior written permission of SYSMEX CORPORATION.
Table of Contents
1.
1.1
1.2
1.3
2.
2.1
2.2
2.3
2.4
2.5
2.6
2.7
2.8
2.9
2.10
2.11
2.12
3.
3.1
3.2
4.
4.1
4.2
4.3
4.4
4.5
5.
5.1
5.2
5.3
5.4
5.5
5.6
5.7
5.8
5.9
5.10
6.
Operation ..............................................................6-1
6.1
6.2
6.3
6.4
7.
7.1
7.2
7.3
7.4
7.5
7.6
7.7
7.8
7.9
7.10
8.
8.1
8.2
8.3
8.4
8.5
9.
Output ...................................................................9-1
10.
10.1
10.2
10.3
10.4
10.5
10.6
Calibration ..........................................................11-1
11.1
11.2
11.3
11.4
11.5
11.
12.
12.1
12.2
12.3
12.4
13.
13.1
13.2
13.3
13.4
13.5
13.6
13.7
13.8
13.9
13.10
13.11
13.12
13.13
13.14
13.15
13.16
13.17
14.
14.1
14.2
14.3
14.4
15.
15.1
15.2
15.3
15.4
15.5
15.6
15.7
15.8
15.9
15.10
15.11
Warranty .............................................................16-1
17.
Glossary .............................................................17-1
18.
Appendix ............................................................18-1
19.
20.
Index ...................................................................20-1
16.
Introduction
1. Introduction
The Sysmex pocH-100iV Diff is an automated hematology analyzer for
use in veterinary laboratories, and veterinarian office laboratories.
The pocH-100iV Diff is a compact instrument, which is designed for
easy operation. For each operating step, online help is available to
support the user.
The pocH-100iV Diff performs a reliable analysis of nineteen (19)
parameters.
The analysis results are displayed on the color graphic LCD display. In
addition, three (3) histograms are displayed and/or printed.
Values outside the specified upper and lower limits are marked, for
further analysis and checking.
Analysis results and histograms can be printed out on the built-in thermal
printer.
The instrument can also be connected to a host computer etc., and can be
used as one instrument in an analytical system.
The pocH-100iV Diff is equipped with a rinse cup, and after aspirating a
sample or control blood, the pipette is automatically cleaned. It is not
necessary to wipe the sample pipette (aspirating pipette).
This instrument has been designed to keep acoustic noise generation as
low as possible.
The user can adapt the instrument to his/her needs or existing laboratory
conditions by selecting the appropriate settings.
Before operating this instrument, carefully read this manual.
Keep this manual for further reference. For further information, please
contact your Sysmex service representative.
Note:
Operate the instrument as instructed. Reliability of test
results cannot be guaranteed if there are any deviations
from the instructions in this manual. If the instrument
fails to function properly as a result of either the users
operation not specified in the manual or the users
utilization of a program not specified by Sysmex, the
product warranty would not apply.
1-1
Introduction
Contact Address
Manufacturer
SYSMEX CORPORATION
1-5-1 Wakinohama-Kaigandori
Chuo-ku, Kobe 651-0073
JAPAN
Europe
EC REP
Americas
Asia-Pacific
1-2
Introduction
Biological risks
Indicates the presence of a biohazardous material or
condition.
Warning!
If this sign is ignored and the instrument is operated
incorrectly, a potentially hazardous situation could
result in death or serious injury of an operator, or
grave property damage.
Caution, Hot!
Indicates that the marked item can be hot and should
not be touched.
Caution!
If this sign is ignored and the instrument is operated
incorrectly, there is a potentially hazardous situation
which may result in injury of an operator, adverse
effect on the analysis results, or may cause property
damage.
Important!
Indicates what you need to know in order to maintain
instrument performance and prevent damage.
Note:
Indicates information which will be useful in operating the
instrument.
1-3
Introduction
1.2 Names
CBC
LD
Lower Discriminator
LL
Lower Limit
QC
Quality Control
T1
Trough Discriminator 1
T2
Trough Discriminator 2
UD
Upper Discriminator
UL
Upper Limit
dL
fL
pg
1-4
Unit
Introduction
Analysis parameters
This instrument provides results for the following parameters:
WBC
RBC
HGB
: Hemoglobin concentration
HCT
MCV
MCH
MCHC
PLT
: Number of platelets
LYM%
(Dog/Cat/Cattle/
Horse mode)
OTHR%
(Dog/Cat mode)
OTHR%
: % of middle and large white blood cells to total
(Cattle/Horse mode) cells
They are assumed to be equivalent to WBC
other than lymphocyte.
EO%
(Dog/Cat mode)
LYM#
(Dog/Cat/Cattle/
Horse mode)
OTHR#
(Dog/Cat mode)
OTHR#
: Absolute number of middle and large white blood
(Cattle/Horse mode) cells
They are assumed to be equivalent to WBC
other than lymphocyte.
EO#
(Dog/Cat mode)
W-SCR
: % of small white blood cells to total WBC
(OTHER1-13 mode) (white blood cell-small cell ratio).
1-5
Introduction
W-MCR
: % of middle white blood cells to total WBC
(OTHER1-13 mode) (white blood cell-middle cell ratio)
W-LCR
: % of large white blood cells to total WBC
(OTHER1-13 mode) (white blood cell-large cell ratio).
W-SCC
: Absolute number of small white blood cells
(OTHER1-13 mode) (white blood cell-small cell count).
W-MCC
: Absolute number of middle white blood cells
(OTHER1-13 mode) (white blood cell-middle cell count).
W-LCC
: Absolute number of large white blood cells
(OTHER1-13 mode) (white blood cell-large cell count).
RDW-SD
RDW-CV
MPV
(except Cat mode)
P-LCR
(except Cat mode)
PDW
(except Cat mode)
1-6
Safety Information
2. Safety Information
2.1 Specified conditions of use
The pocH-100iV Diff is a veterinary blood cell counter for screening
purpose, and shall only be used for in vitro analysis of veterinary blood
samples such as dog, cat, cattle and other specific species and artificial
control blood.
Keep long hair, fingers and clothing away from rotating parts.
Should the instrument emit unusual odors or smoke, turn the main
switch OFF immediately and unplug the power cable. Using the
instrument any further bears the risk of fire, electric shock or
personnel injury. Contact your Sysmex service representative.
Do not spill the liquids such as blood samples or reagent on the unit.
Do not put metal objects such as staples or paper clips on the
instrument. This could cause a short-circuit. If this happens after all,
turn the main switch OFF immediately, and unplug the power cable.
Contact your Sysmex service representative.
Should the instrument leak fluid, turn OFF the power switch
immediately, and unplug the power cable. Using the instrument any
further bears the risk of short circuit, fire, electrical shock or
personnel injury. Contact your Sysmex service representative for
inspection.
Never insert the power plug into power sockets other than AC100240 V. Please note that the instrument must be grounded.
2-1
Safety Information
IEC61326-1:1997+A1:1998+A2:2000 (EN61326:97+A1)
Equipment for measurement, control and laboratory use- EMCRequirements
2.5 Installation
2-2
Never touch waste, or parts having been in contact with waste, with
your bare hands.
Safety Information
2-3
Safety Information
Make sure the reagents used with the instruments are kept level or
below the main unit of the instrument. Do not put reagents on top of
the instrument.
Important!
Strictly follow the measures of first aid in the
laboratory:
2-4
Safety Information
Control blood must always be stored in an upright position irrespective of whether the vial has been opened or is still closed.
Always wear protective garment and gloves for all service and
maintenance work. Use only specified tools and parts. After
completion of work, wash hands with disinfectant. Instrument
surfaces in contact with blood is potentially biohazardous.
When performing out maintenance work, use only the specified tools
and parts. Install only such spare or replacement parts intended for
this equipment.
Do not use any organic solvent, acid, or alkaline agent. These will
affect the instrument surface finish and may cause corrosion or
discoloration.
If the instrument is not operated every day, "Blank Error" may occur.
In this case, follow the instructions displayed in the action message
screen.
2.9 Maintenance
Biological risks
To avoid risks of infections, wear protective garments
and gloves for all cleaning or maintenance work. After
completion of work, disinfect your hands and wash
them afterwards. Otherwise, there is a risk of infection
by pathogens.
2-5
Safety Information
Warning!
This equipment must be Grounded.
PUSH
PUSH
SH
PU
Head
Caution, Hot!
The printer head becomes hot. Use caution.
Caution!
Static electricity may damage the printer head. Do not
touch with hands.
2-6
Safety Information
:
BR
BR :
LAN
Caution!
Static electricity may damage the electronic circuit
via the connectors on the right side. Do not touch
connector pins with hands.
Turn the main switch OFF before inserting or
removing connectors or program cards.
Caution!
Contact with static electricity at the lower left part at
the front side may result in abnormal instrument
operation.
During operation, do not touch any parts other than
the contrast adjustment lever.
Caution!
When opening the detector cover to clean the
transducer aperture, follow the instructions in Section
13.10 Clean aperture of TD (Transducer) chamber
(Drain TD Chamber).
Because there is a risk of electric shock, do not open
this cover for any other purpose.
Detector cover
2-7
Safety Information
Caution!
When opening the right side cover for maintenance,
turn the main switch OFF and disconnect the mains
connection (inlet).
Because there is a risk of electric shock and of
pinching hands by the moving parts, do not open this
cover for any other purpose.
2.12 Personnel
Personnel using this instrument must read the Instructions for Use
thoroughly beforehand, and must operate the instrument correctly.
If the instrument requires service, consult the Instructions for Use for
troubleshooting information. If additional repair is required, contact
your Sysmex representative.
2-8
July 2005
3-1
(1) Main
power switch
(2) Aspirating
pipette
BR
Warning!
The tip of the pipette is sharp. Do not touch the tip
with fingers.
July 2005
Caution!
DO NOT place a sample tube with a cap made of
plastic resin.Pipette may be permanently damaged.
3-2
Caution!
Use only program cards specified by Sysmex.
July 2005
3-3
Biological risks
To avoid risks of infections, wear protective garments
and gloves for all cleaning or maintenance work. After
completion of work, disinfect your hands and wash
them afterwards. Otherwise, there is a risk of infection
by pathogens.
July 2005
3-4
Warning!
To avoid electrical shock, disconnect power cord
before servicing.
(The main switch is not the disconnection device.)
For the continued protection against risk of fire,
replace only with fuse of the specified type and
current ratings.
July 2005
3-5
July 2005
3-6
Reagents
4. Reagents
4.1 pocH-pack D
Intended purpose
Diluent for use in hematology analyzers.
Storage and shelf life after first opening
The expiration date is shown on the outer packaging. Store the pocHpack D at 1 - 30C. If an unopened pocH-pack D is stored at 1 to 30C, it
remains usable for 12 months after the manufacture.
Once opened (connected to the instrument), product stability of the
reagent is a maximum of 60 days.
Any pocH-pack D revealing signs of contamination or instability, as
indicated by cloudiness or color change, should be replaced.
Methodology
The pocH-pack D is a ready-to-use diluent for DC detection and
absorbance analysis of whole blood.
Composition
Sodium Chloride
Boric acid
Sodium Tetraborate
EDTA-2K
6.38 g/L
1.0 g/L
0.2 g/L
0.2 g/L
Ambient temperature
Use the pocH-pack D at 15 - 30C. If analysis is performed at
temperatures exceeding 30C or below 15C, correct analysis results
may not be obtained.
Specimen
Use whole blood sample collected in EDTA anticoagulant.
Additional special equipment
July 2005
The pocH-pack D is solely intended for use with Sysmex reagents and
analyzers.
If other reagents are used, the product performance of Sysmex
instruments cannot be guaranteed.
Sysmex pocH-100iV Diff Instructions for Use
4-1
Reagents
4.0 g/L
3.3 g/L
Ambient temperature
Specimen
Use whole blood sample collected in EDTA anticoagulant.
4-2
Reagents
Additional special equipment
The pocH-pack LVD is solely intended for use with Sysmex reagents
and analyzers.
If other reagents are used, the product performance of Sysmex
instruments cannot be guaranteed.
4.3 CELLCLEAN
Intended purpose
Strong alkaline detergent used to remove lyse reagents, cellular residuals
and blood proteins remaining in the hydraulics of the instrument.
Warning and precautions
Warning!
Avoid contact with skin and eyes. In case of skin
contact, flush the area with water.
In case of contact with eyes, rinse immediately with
plenty of water and seek medical advice.
If swallowed, seek medical advice and follow MSDS.
Storage and shelf life after first opening
Store CELLCLEAN in a dark place at 15-30C.
Avoid exposure to direct sunlight, if exposed to direct sunlight, the
chlorine component will degrade and the effectiveness of this detergent
will be lost depending upon the time period of exposure. Once opened,
this reagent should be used within 60 days.
Methodology
CELLCLEAN is a detergent used to clean the instrument in order to
remove residuals of lyse reagents, cellular residuals and blood proteins
from the hydraulic systems, transducer, whole blood aspiration piercer
and the Hgb flow cell.
Composition
5.0 %
July 2005
Sodium Hypochlorite
4-3
Reagents
4.4 EIGHTCHECK-3WP
Please see Section 10.1 Control material.
Intended purpose
Control blood for testing the precision and accuracy of automated and
semi-automatic hematology analyzers. Do not use EIGHTCHECK-3WPN, EIGHTCHECK-3WP-L and EIGHTCHECK-3WP-H for the
calibration of the system!
Warning and precautions
The human blood used for the production of EIGHTCHECK-3WP-N,
EIGHTCHECK-3WP-L and EIGHTCHECK-3WP-H has been tested
with licensed reagents (Food and Drugs Administration's Bureau of
Biologic, USA) and has been found non-reactive for Hepatitis B Surface
Antigen, Hepatitis C Virus (HCV) and HIV (HIV1+HIV2) Antibody.
However, none of the test methods known today can guarantee that
products based on human blood are not infectious. In keeping with good
laboratory practice, this product should be considered potentially capable
of transmitting infectious disease.
Storage and shelf life after first opening
EIGHTCHECK-3WP-N, EIGHTCHECK-3WP-L and EIGHTCHECK3WP-H are to be stored according to the instructions in the package
insert.
When handled in this manner, the unopened product is guaranteed stable
until the expiration date stated on the package.
July 2005
4-4
Reagents
Batch code
Use by
Temperature limitation
Manufacturer
July 2005
4-5
July 2005
Reagents
4-6
Initial Operation
5. Initial Operation
5.1 Delivery, storage until installation
Parts No.
Description
Quantity
461-2406-6
462-3523-6
5-1
Initial Operation
No.
5-2
Parts No.
Description
Quantity
265-4731-5
442-3047-7
442-3045-0
033-0861-0
033-0891-1
033-0871-7
442-3044-6
Adapter
(Color: cream)
10
033-0881-4
11
442-3042-9
12
462-4846-1
13
423-1776-2
14
266-5330-1
2
Revised March 2006
Initial Operation
No.
Parts No.
Description
Quantity
15
462-2381-8
Screwdriver (+)
16
462-2390-1
Screwdriver (-)
17
033-0413-9
(Color: orange)
18
023-2441-5
(Color: blue)
19
033-0041-1
20
367-2170-9
Reagent Tray
21
266-7110-2
22
369-5172-1
Sticker
(For Veterinary Use)
5-3
Initial Operation
300 mm
150 mm
or more
150 mm
or more
350 mm
460 mm
Width
(mm/in)
Depth
(mm/in)
Height
(mm/in)
Weight
(kg/lb)
300/11.8
460/18.1
350/13.8
Approx.
17/37.4
Warning!
Do not place anything on the top panel. This may
cause heat build up, and may result in the instrument
failing to operate correctly.
In addition, if fluids are spilt in the instrument, short
circuits and smoking may result.
5-4
Initial Operation
1. Set the reagents and waste bottle in the provided reagent tray, then
remove the caps.
The cap that is attached to the reagent bottle will be needed later
when disposing the waste bottle.
pocH-pack LVD
Reagent tray
Caution!
Leave the reagent at room temperature (15 30C) for at least 24 hours before use. Or a
correct analysis result will not be obtained.
2. Insert the container spout kits and float switch into the reagent bottles
and waste bottle, respectively. Then apply the caps.
Container
spout kit
Float switch
Waste
bottle
pocH-pack
D and
pocH-pack
LVD
Caution!
Do not insert the container spout kit and float
switch into a wrong bottle.
5-5
Initial Operation
Float switch
connector for
waste bottle
Diluent inlet
nipple (Blue)
3. On the rear side of the instrument connect the tubes of the container
spout kits and the waste outlet nipple as well as the connector at the
float switch to its connection.
Lyse reagent
inlet nipple
(Purple)
Caution!
Do not connect the tubes to the wrong nipples.
4. Using the provided coil tube, lump the tubes together.
Waste outlet
nipple (Red)
Caution, Hot!
The printer head becomes hot. Use caution.
Caution!
Static electricity may damage the printer head. Do not
touch with hands.
Push
2. Remove the tape holding the end of the printer paper, then set the
printer paper into the printer paper holder.
Tape holding
5-6
Initial Operation
3. Close the printer paper holder so that the roller catches the paper.
Roller
Important!
Set the paper straight in the correct direction. If
inserted at an angle, the paper may become
jammed.
The printer cover must be closed securely until a
"click" sound is heard. If the cover is not closed
completely, an error will occur.
Thermal head
Important!
The bar code reader is not included as a standard
accessory. Refer to the bar code reader manual for
detailed information on the connection of a bar code
reader, see Section 15.4 Connecting the bar code
reader.
5-7
Initial Operation
Warning!
Be sure to ground the instrument.
Improper grounding may cause electrical shock.
5-8
Initial Operation
Ready
Menu
Main
ID
1
Set a mixed
sample, and
Press [RUN].
Species (1)Dog
RUN
select
QC
Result
Shutdown
Not Ready
Top
Menu
Str.Data
Chg.Reag
Calib.
Settings
Maint.
Not Ready
Top
Settings
Note:
If a password has been set, the password input screen will
appear. Enter the password. No password is set when the
instrument is shipped; the password input screen will not
appear, until a password is set.
Enter Password.
Not Ready
Top
Settings
Host Output
Date/Time
Built-in Printer
Species
Network
Quality Control
Password Setting
User Information
Print Settings
System
5-9
Initial Operation
Not Ready
Top
Date/Time
Format
Year
dd/mm/yy
2003
Month
02
Day
03
yy/mm/dd
2003/02/03
mm/dd/yy
02/03/2003
dd/mm/yy
03/02/2003
Not Ready
Top
Date/Time
Hour
10
Minute
15
Ent.
Quit
5-10
Initial Operation
Sample collection tube settings
9 mm
S-MONOVETTE
(SARSTEDT) sample
collection tube
Standard sample
collection tube
Ready
Menu
Main
ID
Caution!
When S-MONOVETTE (SARSTEDT) is selected,
use S-MONOVETTE EDTA K collection tubes
manufactured by SARSTEDT.
S-MONOVETTE (SARSTEDT) sample collection
tubes cannot be used together with other sample
collection tubes.
1
Set a mixed
sample, and
Press [RUN].
Species (1)Dog
RUN
select
QC
Result
Shutdown
Not Ready
Top
Menu
Str.Data
Chg.Reag
Calib.
Settings
Maint.
Not Ready
Top
Settings
Note:
If a password has been set up, the password input screen will
appear. Enter the password. No password is set when the
instrument is shipped; the password input screen will not
appear until a password is set.
Enter Password.
5-11
Initial Operation
Not Ready
Top
Settings
System
Host Output
Date/Time
Built-in Printer
Species
Network
Quality Control
Password Setting
User Information
Print Settings
Not Ready
System
Units
Type 2
Language
English
Tube
STANDARD
Volume
Alarm
Top
Type 1
Quit
5-12
Initial Operation
Adjusting the contrast of the LCD screen
Slide the front cover of the instrument to the left to open it. The LCD
contrast can be adjusted with the contrast adjustment knob located on the
right side of the pinch valve. Slide the knob to the left to darken the LCD,
and to the right to brighten it.
Note:
If no operation is performed on the LCD screen for a
certain period of time, the LCD backlight illuminance will
decrease automatically to conserve electric power.
(backlight saving timer function.) Touch any portion on the
LCD screen to return to a normally illuminated LCD
screen.
5-13
Initial Operation
5-14
Operation
6. Operation
6.1 Screen display
To a large extent, the instrument is menu-driven. The LCD screen shows
which functions or submenus are available. Also, the instrument's
operating status and the progress of a measurement, respectively, are
displayed.
Main screen/Menu screen
Ready
After turning the power ON, the Sysmex logo appears, and the startup
operation is performed. Then the Main screen will appear. When the
[Menu] button on the Main screen is pressed, the Menu screen will
appear.
Menu
Main
ID
1
Set a mixed
sample, and
Press [RUN].
Species (1)Dog
RUN
select
QC
Result
Shutdown
Not Ready
Top
Menu
Str.Data
Chg.Reag
Calib.
Settings
Press the [Top] button on the upper right of the screen to return to the
Main screen from the Menu screen.
Maint.
System area
(1)(2)(3)(4)
(5)
Ready
Menu
Main
ID
Species (1)Dog
Send a mixed
sample, and
press [RUN].
(6)
RUN
select
Result
Shutdown
QC
Aspirating:
Running:
Not Ready:
6-1
Operation
(2) Screen name
Displays the screen name currently displayed in the Data Processing
Area.
Possible screen names: Main, Result, Menu, Settings, etc.
(3) Remaining Reagent volume indicator
Displays the remaining reagent volume by eleven levels.
Note:
The remaining reagent volume indicator should be used
only as a guide. Depending on the usage method of the
instrument, the remaining reagent volume may not be
correctly displayed.
Caution!
If the remaining reagent is decreased and the
Replace pocH-pack D" or "Replace pocH-pack LVD"
error has occurred, replace the reagent with a new
one.
(4)
(5)
(help) button:
(6)
6-2
Operation
Data processing area
Not Ready
Top
Result
ERROR
WBC
LD
T1
T2
The Data Processing Area at the center of the LCD screen changes
together with the screen contents.
(1)Dog
HC Out
Menu
Main
ID
Species (1)Dog
The messages and the buttons are displayed in the Basic Operation area
at the bottom of the LCD screen.
Press the corresponding button to execute a basic menu operation and the
cursor operation.
Set a mixed
sample, and
press [RUN].
RUN
select
QC
Result
Dhutdown
Top
help
Printer Error
button has
Retry
6-3
Operation
Dialog screen
This box prompts the operator for confirmation. Dialogs include the
Error dialog when errors occur, the Confirmation dialog when
settings are changed, and the Numerical keys dialog for entering
numerals.
Error
"Printer Error" occured.
Quit
Dialogs appear at the top of the screen displayed at that time. Buttons at
the bottom at the screen cannot be pressed then.
<Error dialog>
OK
Cancel
<Confirmation dialog>
Display column
ID
The Main screen sample ID, setting values, and other items which can be
changed by the operator appear as white boxes with shadows.
These boxes are referred to as display columns in the Instructions for
Use.
Press on a display column to input information.
Selections
Type1
Type1
Type2
Type3
For settings which require the selection of one setting from multiple
options, the options are displayed when the display column is pressed.
Press the selection to input that value. If all of the options cannot be
displayed on the screen, the [more] button is displayed in the options
area. Press the [more] button to change the displayed options.
Type4
more
6-4
Operation
Numerical keys dialog
The numerical keys dialog appears for entering numerals. The buttons
displayed differ depending whether numerical keys or alphabetical keys
are chosen. But the operations are the same.
ALPH
Ent.
Enter numerals.
.
Enter symbols.
Changes the entered value to zero in the
case of an input of numerals (when the
[ALPH] button is not displayed).
Erases one character in the case of an
input of characters (when the [ALPH]
button is displayed).
Ent.
ALPH
ALPH
alph
ALPH
NUM
(Enter button):
ALPH
alph
or
NUM
Press this switching button to change the characters which are displayed
and which can be input.
Switching button display
ALPH
alph
abc
Remarks
8
(numerical input)
(Input 7.)
A, B, C
(alphabetic capital letter input)
(Input space.)
a, b, c
(alphabetic small letter input)
(Input space.)
NUM
ABC
Example of characters
which can be input
6-5
Operation
Press the
ABC
Press the
ABC
Press the
ABC
Pressing the
ABC
Input status
Explanation
Changes to alphabetical capital letter
mode.
ALPH
Confirms A.
AB
AB
Confirms B.
A BC
DEF
A BCD
Confirms C. Inputs D.
alph
A BCD
A BCD e
Inputs e.
A BCD e
Confirms e.
ABC
Ent.
ABC
Ent.
ABC
def
Ent.
Ent.
6-6
Operation
QC
Clog Removal
Drain TD Chamber
Result
Clean Transducer
Shutdown
Clean W. Chamber
Status Display
Menu
Calibration LCD
Str.Data
Chg.Reag
Setting Seq.
Maint.
Drain Reagent
Auto Calib.
Calib.
Manual Calib.
Print Cal. His.
Settings
System
Date/Time
Species
Quality Control
User Information
Host Output
Built-in Printer
Network
Password
Print set value
6-7
Operation
Operation:
Timing:
Cancel:
Touch any part of the LCD screen, or open and close the sample
position once.
Purpose:
Operation:
Timing:
Activated when the instrument has not been operated for 2 hours.
Cancel:
6-8
Purpose:
Operation:
Timing:
Cancel:
Sample Analysis
7. Sample Analysis
7.1 Introduction
This chapter explains the entire operating procedure from startup to
shutdown of the instrument, as well as the operating procedure
Page 7-2
Switching ON
Page 7-3
Quality control
Page 7-4
Analysis
Page 7-5
Page 7-13
Page 7-13
Page 7-14
7-1
Sample Analysis
Waste bottle
Biological risks
Always wear protective garments and gloves
when handling the waste fluid. After work is
completed, wash hands with disinfectant.
When handling (disposing) the waste fluid,
dispose it appropriately in accordance to local
laws and regulations, which considers for the
disposal of medical waste and infectious waste.
1. Check if the waste bottle is not full and has enough room for a day's
work. If the waste bottle is nearly full, dispose the waste fluid.
2. Make sure the cap is fit.
3. Check that the tube is not bent.
Printer paper
1. Open the printer cover on the top of the instrument, and check that
the paper supply is adequate for the number of samples expected for
the day.
For the replacement procedure, see Section 13.15 Replace thermal
printer paper.
2. Check to see that the paper is properly aligned.
Important!
Use only printer paper recommended by Sysmex.
Low quality paper may shorten the life of the printer
head.
7-2
Sample Analysis
7.4 Switching ON
After completion of all checks, the main switch can be turned ON.
Self-check
Running
Top
Start up
Execute Cancel
After the main power switch is turned ON, the instrument performs a
Self-check. This process takes approximately 2 minutes.
In order to ensure optimal instrument conditions for use at all times,
certain parts require periodic maintenance. This instrument includes
counters which record the number of times that each of these parts is
used. If the counter value is above 150 when the main power switch is
turned ON, or if 2 weeks have passed since the previous maintenance, a
screen will appear prompting the operator to perform periodic
maintenance, i.e. transducer cleaning. If the counter value exceeds 1500,
or if 3 months have passed since the previous maintenance, a screen will
appear prompting the operator to perform periodic maintenance, i.e.
waste chamber cleaning. Follow the instructions on the screen and
perform the required maintenance.
If an error is detected during the Self-check, an error message appears on
the LCD screen. Turn the instrument main power switch OFF.
Wait 15 seconds, then turn it ON again.
Background check
Running
Start up
Please wait.
Menu
Press the [OK] button on the error dialog. The alarm sound stops.
Press the
button and the action message will appear.
7-3
Sample Analysis
Running
Start up
Menu
Please wait.
Note:
"Blank Error" may occur, if the instrument is not operated for
several days.
When the specimen is left unrefrigerated for more than 4 hours certain
changes occur within blood cells, which may produce misleading results
of clinical significance. Red blood cells swell, the MCV increases. The
total WBC count may decrease and the reliability of the electronic
differential white blood cell count diminishes. The degree of change is
variable depending on the specimen and the temperature at which it is
stored. These changes are largely prevented by storage at 2 to 8C.
7-4
Sample Analysis
7.7 Analysis
Sample preparation
The instrument can be used to analyze whole blood to which an EDTA
anticoagulant has been added.
The blood sample should be collected by vein-puncture.
Aspirated sample volume: Approximately 15 L
Caution!
Blood in which clotting or platelet aggregation has
occurred cannot be analyzed.
Important!
Mix the sample promptly after the blood is drawn.
If mixing is insufficient, platelet aggregation may
occur.
Note:
All performance claims given in this manual were
generated using specimens in EDTA anticoagulant. Results
may be affected by the use of other anticoagulants.
Therefore, each laboratory should develop protocols for
handling specimens collected in their anticoagulants.
7-5
Sample Analysis
Setting the species
Ready
Menu
Main
ID
1
Set a mixed
sample, and
Press [RUN].
Species (1)Dog
RUN
select
QC
Result
Shutdown
Ready
Menu
Main
ID
Species (1)Dog
(5) OTHER1
S
s (6) OTHER2
p
(7) OTHER3
X ^ [ g
select
QC
Result
more
1/6
close
Shutdown
Caution!
The analysis data of the OTHER1 - OTHER13
mode is for research.
Important!
This setting is kept until the species is selected in the
next time or the power switch is turned OFF then ON
again. Always check the species selection before
performing analysis.
Note:
Regarding the species setting, see "Species specific
settings" in Section "12.2 Possible settings".
7-6
Sample Analysis
Entering a sample ID
Sample ID can be entered by the following two methods.
Note:
If no sample ID is entered, it will be incremented by 1 for
each new analysis.
[Example]
123 124
9999999999999991
12-312-4
12-999 12-000
A999000
Caution!
When setting a sample ID to 0, the analysis
result will not be stored as data, and it will neither
be printed automatically with the built-in thermal
printer, nor can it be transferred to the host
computer automatically. Also, sample ID 0 will
not be incremented automatically.
7-7
Sample Analysis
Input via numerical keys dialog
Ready
Menu
Main
ID
1
Set a mixed
sample, and
Press [RUN].
Species (1)Dog
RUN
select
QC
Result
Shutdown
Not Ready
Menu
Main
ID
Species (1)Dog
Set a mixed
sample,
4 and
5
Press [RUN].
QC
Result
ALPH
6
3
C
:XRUN
:^ :[ :g
select
Ent.
Shutdown
7-8
Do not use any other characters than alphanumerics, hyphens and space on the bar code
label.
Caution!
When using a bar code label, affix it properly so it
is flat and smooth without creases or flares.
Sample Analysis
Analyzing samples
Caution!
When a tube with a large diameter (approximately
15 mm diameter) is used, it may be difficult to set
it in the sample position. Do not force the sample
tube into the sample adapter or force the sample
adapter into the sample position. This may
interfere with opening the sample position.
Important!
Push the top of the sample position to open it
automatically. If you attempt to force it open, the
instrument may be damaged.
If there is an object such as a pencil under the
sample position, it cannot be opened properly.
Close the sample position once, and make sure
that there are no objects underneath the sample
position.
Biological risks
Wear protective garments and gloves when
performing sample analysis. After completion of work,
wash hands with disinfectant.
2. Place the correct adapter in the sample position.
Adapter
Caution!
Be sure to use the correct adapter for the sample
tube being used.
The sample tube adapters (15 mm diameter tube
adapter and S-MONOVETTE (SARSTEDT) 2.7
mL adapter) are optional parts in some areas.
Adapter name
Product code
Adapter color
442-3032-1
Black
442-3038-3
Red
7-9
Sample Analysis
3. Mix the sample thoroughly.
The sample can be analyzed from either a sample tube or a micro
tube.
Important!
Vigorously mixing the sample can damage the blood
cells and cause bubbles to form in the sample. If this
occurs, correct analysis results will not be obtained.
4. Remove the sample tubes cap. Then, set it in the adapter and close
the door.
a: Sample tubes
Set a sample tube in the adapter, and close the door.
Warning!
When a sample tube with a cap is used, manually
remove the cap before analysis. The pipette might be
permanently damaged, if the cap was not removed.
b: Micro tubes
If the micro tube has a cap, remove it.
Adapter
442-3045-0
Adapter for
Control blood
Caution!
When using micro tubes, be sure to place them in
the correct adapter.
7-10
Sample Analysis
micro tube
Menu
Main
ID
Species (1)Dog
Adapter
033-0861-0
Purple
033-0891-1
Green
033-0871-7
Yellow
442-3044-6
Cream
033-0881-4
Blue
442-3042-9
Gray
Caution!
When using a micro tube attached with a cap, such as
Eppendorf tube, set the cap part close toward you to
avoid mechanical problems.
micro tube
with a cap
Ready
Product code
Set a mixed
sample, and
Press [RUN].
RUN
select
QC
Result
Shutdown
7-11
Sample Analysis
Ready
Menu
Main
ID
1
Set a mixed
sample, and
Press [RUN].
Species (1)Dog
Note:
If the [RUN] button is pressed without changing the
sample ID, a warning dialog will appear on the screen.
Warning
RUN
Result OK
QC
Cancel
Shutdown
Not Ready
Menu
Main
ID
Species (1)Dog
Set a mixed
sample, and
press [RUN].
Warning!
If the [RUN] button is pressed while the sample
position door is open, a warning dialog appears. Set a
tube adapter and close the door before pressing the
[RUN] button.
Warning
X ^ [ g
Q @
OK
fl
Running
Top
Measure
ID 123456789012345
(1)Dog
WBC
RBC
HGB
HCT
PLT
x103/uL
x106/uL
g/dL
%
x103/uL
Asp. is finished.
Important!
Do not open the sample position while Aspirating is
displayed. If the sample position is opened while
displaying Aspirating, a correct analysis result will
not be obtained.
The analysis result of WBC and HGB are displayed on the LCD screen
about 90 seconds after starting the analysis. The analysis results for all
parameters are displayed about 125 seconds after the start.
When the status display indicates Ready, the next sample can be
analyzed. Repeat the process as described above.
7-12
Sample Analysis
Result
Top
The results of the last analysis performed analysis are displayed on the
LCD screen.
The complete display consists of 5 screen pages.
Switch the pages by pressing the [] buttons.
For further information regarding the displays, see Section 8.1 Latest
sample.
Press the [Top] button to return to the Main screen.
1/5
HC Out
Note:
If no buttons on the screen are pressed, the screen will
automatically return to the Main screen when the next
analysis can be performed.
Press the [Result] button on the Main screen to display the
analysis results.
Note:
User settings can also be made for automatic output.
(See Chapter 12. Instrument Setup.)
7-13
Sample Analysis
Executing a Shutdown:
To be carried out all analysis have been performed, or at least once
every 24 hours, if the instrument is used in continuous operation.
Caution!
If the instrument is used continuously without
performing the shutdown sequence, protein build-up
on the internal parts may prevent obtaining correct
analysis results, and may damage the instrument.
Important!
If the instrument is turned OFF without executing a
Shutdown, water droplets may come out of the pipette
or deposits may build-up on the rinse cup.
Note:
It takes approximately two minutes to complete the
Shutdown sequence.
Ready
Menu
Main
ID
Species (1)Dog
Set a mixed
sample, and
Press [RUN].
RUN
select
QC
Result
Shutdown
Not Ready
Top
Shutdown
Execute Shutdown.
7-14
Execute Cancel
Sample Analysis
Running
Shutdown
Top
Please wait.
3. Check that the shutdown sequence was completed and the display of
the shutdown completion screen.
Turn OFF the main switch on the right side of the instrument.
When the [Restart] button is pressed, the Main screen will appear.
Restart
7-15
Sample Analysis
7-16
The analysis results can be printed with the built-in thermal printer or it
can be output to the host computer.
Important!
The QC data is also counted in this number.
Top
Result
Species
Analysis error flag
Volume distribution
flag
Numeric value
abnormal flag
Sample ID
HCT
PLT
40. 3
223
Analysis data
%
x103/uL
1/5
HC Out
8-1
Top
Result
Species
WL+
WBC
RBC
HGB
HCT
MCV
MCH
MCHC
PLT
Volume distribution
flag
Numeric value
abnormal flag
Sample ID
8.9
5.08
12.9
38.6
76.1
25.4
33.4
223
x103/uL
x106/uL
g/dL
%
fL
pg
g/dL
x103/uL
Analysis data
2/5
HC Out
Top
Result
Species
Sample ID
Analysis Mode
WBC Histogram
LD
T1
T2
8.9
31.0
8.5
60.5
2.8
0.8
5.3
x103/uL
%
%
%
x103/uL
x103/uL
x103/uL
Analysis data
3/5
HC Out
Revised March 2006
30 fL
120 fL
180 fL
WBC WL+
LYM%
OTHR%
EO%
LYM#
OTHR#
EO#
8-2
Top
Result
Species
Sample ID
Analysis Mode
RBC Histogram
LD
35 fL
UD 250 fL
Analysis data
4/5
HC Out
Top
Result
Species
Sample ID
Analysis Mode
PLT
PDW
MPV
P-LCR
PLT
PLT Histogram
LD
UD
WL+
223
7.6
10.9
18.0
x103/uL
fL
fL
%
Analysis data
4 fL
20 fL
5/5
HC Out
8-3
Analysis parameters:
Analysis parameters:
Analysis parameters:
Analysis parameters:
Analysis parameters:
Note:
When the analysis was performed in the OTHER1 OTHER13 mode, LYM%, OTHR%, EO%, LYM#,
OTHR# and EO# are displayed as W-SCR, W-MCR,
W-LCR, W-SCC, W-MCC and W-LCC respectively.
8-4
Caution!
The analysis data of the OTHER1 - OTHER13
mode is for research.
Top
Result
HCT
PLT
40. 3
223
%
x103/uL
1/5
HC Out
Analysis data without a preceding sign are within the preset limits.
Preceding signs indicate an analysis result which is out of the prescribed
limits:
Sign
Exposition
Result is unreliable.
Note:
The values for + and - reference limits can be set by the
customer. Check the Reference Limit section in Chapter
12. Instrument Setup.
If an analysis error has occurred and a value is not available, one of the
following is displayed:
Display
Exposition
+++.+
***.*
---.-
Note:
When the analysis was performed in the Cat mode,
PDW , MPV and P-LCR are displayed as spaces.
When the analysis was performed in the Cattle or
Horse mode, EO% and EO# are displayed as spaces.
Exposition
Error at the lower discriminator for WBC
Error at the upper discriminator for WBC
Trough discriminator T1 could not be determined.
Trough discriminator T2 could not be determined.
Small cells are inaccurate.
Middle cells are inaccurate.
Large cells are inaccurate.
8-5
Exposition
Error at the lower discriminator for RBC
Error at the upper discriminator for RBC
Distribution width (20%) can not be calculated.
There are multiple peaks.
Error at the lower discriminator for PLT
Error at the upper discriminator for PLT
For details about sample flagging, see Chapter 8.5 Histogram error
flags.
Manual analysis flag
Displays manually analysed parameters.
Flag
[S]
[W]
[R]
[P]
Exposition
Species are changed.
Discrimination positions of WBC are moved.
Discrimination positions of RBC are moved.
Discrimination positions of PLT are moved.
WBC histogram
Displays a histogram for WBC.
RBC histogram
Displays a histogram for RBC.
PLT histogram
8-6
Menu
Main
ID
1
Set a mixed
sample, and
Press [RUN].
Species (1)Dog
RUN
select
QC
Result
Shutdown
Not Ready
Top
Menu
Str.Data
Calib.
Chg.Reag
Settings
Maint.
8-7
Top
Man. Ana.
HCT
PLT
40. 3
223
%
x103/uL
1/5
HC Out
Caution!
Manual Analysis can not be performed on the data
with sample number 0.
Re-selection of species
Not Ready
Top
Result
HCT
PLT
40. 3
223
1. Press the
button on the Analysis screen.
The manual analysis confirmation dialog will appear.
%
x103/uL
1/5
HC Out
Not Ready
Top
Result
HCT
PLT
40. 3
223
%
x103/uL
1/5
Species WBC
8-8
RBC
PLT
Cancel
Top
Man. Ana.
3. Press the
button or the
9.0
5.07
12.9
38.6
76.1
25.4
33.4
235
x103/uL
x106/uL
g/dL
%
fL
pg
g/dL
x103/uL
Note:
When species are changed, the species name is
reverse-displayed, and the manual analysis flag [S] is
displayed.
1/4
4. Press the
button.
Not Ready
Top
Man. Ana.
ERROR
PLT
PDW
MPV
P-LCR
LD
UD
235
7.8
11.0
18.5
5. Check the re-calculated analysis data, and press the [Top] button.
The save confirmation dialog will appear.
Note:
Analysis values changed by re-calculations
are reverse-displayed.
x103/uL
fL
fL
%
4 fL
20 fL
[Save]
[Quit]
[Cancel]
3/3
Save results?
Save
Quit
Cancel
Caution!
When the [Save] button is pressed, the analysis data
is overwritten.
Top
Result
HCT
PLT
40. 3
223
1. Press the
%
x103/uL
1/5
Species WBC
RBC
PLT
Cancel
8-9
Top
Man. Ana
LD
T1
T2
30 fL
126 fL
180 fL
WBC
LYM%
OTHR%
EO%
LYM#
OTHR#
EO#
8.9
33131.2
8.5
60.5
2.9
0.7
5.3
x103/uL
%
%
%
x103/uL
x103/uL
x103/uL
3. Press the
4. Press the
button or the
discrimination position.
1/3
Note:
When the discrimination positions are changed, these are
reverse-displayed, and the manual analysis flags are
displayed.
[W]
[R]
[P]
Lower Limit
Upper Limit
LD
6 fL (0ch)
T1
T1
LD
T2
T2
T1
UD (49ch)
Discri. to Move
Lower Limit
Upper Limit
LD
5 fL (0ch)
UD
UD
LD
250fL(49ch)
8-10
RBC
Lower Limit
Upper Limit
LD
1 fL (0ch)
UD
UD
LD
40fL(39ch)
button.
Top
Man. Ana.
PLT
PDW
MPV
P-LCR
PLT
LD
UD
223
7.7
11.1
18.3
x103/uL
fL
fL
%
4 fL
20 fL
6. Check the re-calculated analysis data, and press the [Top] button.
The save confirmation dialog will appear.
[Save]
[Quit]
[Cancel]
3/3
Save results?
Save
Quit
Cancel
Caution!
When the [Save] button is pressed, the analysis data
is overwritten.
8-11
Not Ready
Top
Man. Ana.
PLT
PDW
MPV
P-LCR
PLT
LD
UD
223
7.7
11.1
18.3
x103/uL
fL
fL
%
4 fL
20 fL
3/3
Not Ready
OK
Cancel
Note:
When the analysis data of the OTHER1 - OTHER13
mode is saved, the discrimination position save
confirmation dialog will appear.
[OK] : Store new discrimination positions, and returns to
the main screen.
From the next measurement, particle distributions of the
other mode are discriminated with the new positions.
[Cancel] : Not store new discrimination positions, and
returns to the main screen.
Top
Disc. pos.
OTHER1
RBC LD
10 fL
RBC UD
250 fL
PLT LD
4 fL
PLT UD
20 fL
Note:
Discrimination positions for the other mode can be set in
the Settings - Species menu.
Save
8.4 Output
The analysis data can be output on the built-in thermal printer or the host
computer.
[Print]:The built-in thermal printer starts to print analysis results and
setting values, etc.
Important!
The [HC Out] button is displayed only when the host
computer is connected. See Chapter 12.2 Possible
settings.
For host computer output, install software compatible
with pocH-100iV Diff onto the computer to enable
data transfer.
8-12
Flag
Correction
WL
Check smear.
Warm sample and repeat analysis.
If incomplete lysing is suspected, perform a 1:5
dilution of the sample (50 L of whole blood added
to 200 L of diluent) and re-analyze. Adjust the
results for the dilution factor.
RL
Check smear.
Warm sample and repeat analysis.
Manual count.
PL
Check smear.
Warm sample and repeat analysis.
Manual count.
WU
Check smear.
Dilute sample and repeat analysis.
If incomplete lysing is suspected, perform a 1:5
dilution of the sample (50 L of whole blood added
to 200 L of diluent) and re-analyze. Adjust the
results for the dilution factor.
RU
Check smear.
Warm sample and repeat analysis.
PU
Check smear.
Warm sample and repeat analysis.
Manual count.
Take an another blood sample.
DW
(RBC)
Check smear.
DW
(PLT)
Check smear.
If cyroglobulins are suspected, first warm the
sample and repeat analysis. If error message
persists, perform a plasma replacement (remove
plasma and replace with equal volume of diluent)
and repeat analysis.
MP
(RBC)
Check smear.
MP(PLT)
Check smear.
8-13
Correction
T1
Check smear.
If incomplete lysing is suspected, perform a 1:5
dilution of the sample (50 L of whole blood added
to 200 L of diluent) and re-analyze. Adjust the
results for the dilution factor.
T2
Check smear.
If incomplete lysing is suspected, perform a 1:5
dilution of the sample (50 L of whole blood added
to 200 L of diluent) and re-analyze. Adjust the
results for the dilution factor.
F1, F2, F3
Check smear.
If incomplete lysing is suspected, perform a 1:5
dilution of the sample (50 L of whole blood added
to 200 L of diluent) and re-analyze. Adjust the
results for the dilution factor.
Note:
Since cat platelets are known to be difficult to discriminate
from the red blood cells, it is a common problem in the cell
counters and a PU flag is often reported.
8-14
Output
9. Output
Analysis results, quality control and calibration data can be output to
the built-in thermal printer or transmitted to the host computer.
The above-mentioned devices can be selected from the screen menu.
[Print]:The built-in thermal printer starts to print analysis results and
set values, etc.
[HC Out]:Output the data to the host computer. It is possible to
output to either the serial port (RS-232C) or LAN (Ethernet),
depending on the user setting.
Device activation/deactivation
Ready
Menu
Main
1. Check to see that the device is properly connected and switched on.
2. Press the [Menu] button.
The Menu screen will appear.
ID
1
Set a mixed
sample, and
Press [RUN].
Species (1)Dog
RUN
select
QC
Result
Shutdown
Not Ready
Top
Menu
Str.Data
Chg.Reag
Calib.
Settings
Maint.
Not Ready
Top
Setting
Note:
If a password has been set-up, the password input screen
will appear. Enter the password.
Enter Password.
9-1
Output
Not Ready
Top
Settings
System
Date/Time
Species
Quality Control
User Information
Not Ready
Top
HC Out.
Connect
Disable
Auto Out.
Enable
Format
pocH
T. Rate
9600bps
Save
Not Ready
Top
HC Out.
Connect
Disable
Auto Out.
Enable
Format
pocH
T. Rate
9600bps
Press the [Cancel] button to discard all changes made, and the
dialog will be closed.
7. Press the [Top] button in order not to update the changed settings
and to return to a main screen.
Quit
Cancel
9-2
Quality Control
After maintenance
As required by regulation(s)
Important!
Do not use any other control material than
EIGHTCHECK-3WP-N, EIGHTCHECK-3WP-L
and EIGHTCHECK-3WP-H. This control blood is
specially developed for the analyzer's measuring
technology.
When opening a new lot, the previously entered
assay values or lot numbers must be erased.
Product name
EIGHTCHECK 3WP-N
EIGHTCHECK 3WP-L
EIGHTCHECK 3WP-H
Intended purpose
Control blood material is used to test the precision and accuracy of
automated and semi-automatic hematology analyzers. Do not use
EIGHTCHECK-3WP-N, EIGHTCHECK-3WP-L and EIGHTCHECK3WP-H for the calibration of the system!
10-1
Quality Control
Warning and precautions
Do not inject or ingest.
The human blood used for the production of EIGHTCHECK-3WP-N,
EIGHTCHECK-3WP-L and EIGHTCHECK-3WP-H has been tested
with licensed reagents (Food and Drugs Administration's Bureau of
Biologic, USA) and has been found non-reactive for Hepatitis B Surface
Antigen, Hepatitis C Virus (HCV) and HIV (HIV1+HIV2) Antibody.
However, none of the test methods known today can guarantee that
products based on human blood are not infectious. In keeping with good
laboratory practice, this product should be considered potentially capable
of transmitting infectious disease.
Composition
EIGHTCHECK-3WP-N, EIGHTCHECK-3WP-L and EIGHTCHECK3WP-H contain stabilized human red blood cells, fixed human white
blood cells and a platelet component in a medium containing
preservatives.
Storage and shelf life after first opening
EIGHTCHECK-3WP-N, EIGHTCHECK-3WP-L and EIGHTCHECK3WP-H are to be stored upright at 2-8C before and after opening.
When handled in this manner, the unopened product is guaranteed stable
until the expiration date stated on the package.
After opening, the product is stable for 7 days if returned to the
refrigerator promptly after use.
EIGHTCHECK-3WP-N, EIGHTCHECK-3WP-L and EIGHTCHECK3WP-H have been tested and found to provide stable parameter values
after at least 12 hours at room temperature (25C).
Additional special equipment
EIGHTCHECK-3WP-N, EIGHTCHECK-3WP-L and EIGHTCHECK3WP-H are intended to be used with SYSMEX reagents and analyzers
only.
Note:
If other control materials are used the product performance
of Sysmex instruments cannot be guaranteed.
10-2
Quality Control
Procedure
Preparing Control Blood
1. Remove a vial of control material from the refrigerator and
equilibrate to room temperature (18-30C) for 15 minutes before use.
2. Place the vial between the palms and roll it back and forth 10 times
(see illustration).
3. Turn the vial upside down and roll 10 more times.
4. Repeat steps 2 and 3 eight times or for a total of 2 minutes. Examine
the bottom of the vial and assure thoroughly mixing by confirming
that there is no pellet of cells adhering to the bottom of the vial
before performing the analysis. If there still is pellet of cells, repeat
step 3.
5. Using the appropriate adapter, analyze the control blood sample in
the same manner as whole blood, according to procedures listed in
the instruments Instructions for Use. Wipe threads of cap and vial
with clean lint-free tissue before replacing cap. Recap vial tightly.
6. Store at 2-8C in an upright position.
Note:
Always check with current control materials insert
instructions.
Manual procedures
Reference method can be applied to EIGHTCHECK-3WP-N,
EIGHTCHECK-3WP-L and EIGHTCHECK-3WP-H. Refer to a manual
for clinical laboratory procedures.
Methodology
Principle of the method
EIGHTCHECK-3WP-N, EIGHTCHECK-3WP-L and EIGHTCHECK3WP-H are to be used as hematology control bloods for the quality
control of any Sysmex Fully Automated and Semi-automated
hematology analyzers. EIGHTCHECK-3WP-N is for the normal level,
EIGHTCHECK-3WP-L is for the low abnormal level and
EIGHTCHECK-3WP-H is for the high abnormal level.
The WBC histogram of EIGHTCHECK-3WP-N, EIGHTCHECK-3WPL and EIGHTCHECK-3WP-H indicate three part distributions when the
instruments particle distribution analysis is used.
The use of stabilized cell preparation for controlling hematology
instrumentation is an established procedure. When handled like a patient
sample measured in QC mode and assayed on a properly calibrated
(HBC, HCT) and functioning instrument, EIGHTCHECK-3WP-N,
EIGHTCHECK-3WP-L and EIGHTCHECK-3WP-H will provide
values within the expected range indicated on the assay sheet.
10-3
Quality Control
Performance characteristics and limitations of the method
A manual differential analysis of white blood cells cannot be
accomplished with EIGHTCHECK-3WP-N, EIGHTCHECK-3WP-L
and EIGHTCHECK-3WP-H.
The PRP (platelet rich plasma) method to assay the platelet count cannot
be accomplished with EIGHTCHECK-3WP-N, EIGHTCHECK-3WP-L
and EIGHTCHECK-3WP-H.
Traceability of control materials
The mean assay values (range) of EIGHTCHECK-3WP-N,
EIGHTCHECK-3WP-L and EIGHTCHECK-3WP-H are derived from
replicate analyses on whole blood calibrated instruments using the
reagents recommended by the equipment manufacturer.
The measuring results for EIGHTCHECK-3WP-N, EIGHTCHECK3WP-L and EIGHTCHECK-3WP-H should be within the relevant
expected range.
The expected ranges listed represent estimates of inter-laboratory
variation, which is usually accounted for by instrument calibration,
maintenance and operating technique.
For this reason, the assay values given are guidelines only used for the
control of the measuring system and are not absolute assays for
calibration.
Disposal
Expired EIGHTCHECK-3WP-N, EIGHTCHECK-3WP-L and
EIGHTCHECK-3WP-H should not be disposed in general waste.
Disposal procedures should meet the requirements of all applicable local
regulations.
References
Henry, J.B. Clinical Diagnostic and Management by Laboratory
Methods. Ed.17. W.B. Saunders.
Philadelphia, PA 1984.
10-4
Quality Control
10-5
Quality Control
10.4 Preparations
If the instrument has not been started up, turn the main power switch ON
and wait until the status display shows Ready.
Control method selection
Ready
Menu
Main
ID
1
Set a mixed
sample, and
Press [RUN].
Species (1)Dog
RUN
select
Result
Shutdown
Not Ready
Top
Menu
Str.Data
Chg.Reag
Calib.
Settings
Maint.
Not Ready
Top
Settings
Enter Password.
Not Ready
Note:
If a password has been set, the password input screen will
appear. Enter the password.
Top
Settings
System
Host Output
Date/Time
Built-in Printer
Species
Network
Quality Control
Password Setting
User Information
Print Settings
10-6
QC
Quality Control
Not Ready
Set QC
QC Method
Data Out.
Top
L-J
Print
Disable:No output.
Print+HC: Output to both the built-in thermal printer and the host
computer.
Important!
When outputting to the host computer, the instrument
outputs to the serial port (RS-232C) or LAN (Ethernet),
depending on the connection settings for host computer.
(See Chapter 12. Instrument Setup.)
In the quality control setting screen, pressing the [Top] button will
display the quit confirmation dialog.
Press the [OK] button to return to the Main screen without
changing the settings.
10-7
Quality Control
Settings for control blood information
Before using new control blood, input the control blood information into
the instrument.
Contents of these settings are the control blood lot ID, expiration date,
TARGET value and LIMIT values for each control parameter.
These can be entered by the following two methods.
+ LIMIT
TARGET
- LIMIT
10-8
Quality Control
Entering from numerical keys dialog
Ready
Menu
Main
ID
1
Set a mixed
sample, and
Press [RUN].
Species (1)Dog
RUN
select
QC
Result
Shutdown
Not Ready
Top
QC Analy
File
Lot ID
[1234567890]
[01/01/2002]
[1234567890]
[01/01/2002]
[1234567890]
[01/01/2002]
Ready
Top
QC Analy
[1]
File
Lot ID
[1234567890]
Expire
[01/01/2002]
Expire
Run
Settings
(1st analysis)
Not Ready
Top
Set QC
File[1]
Lot ID
1234567890
Select Input
parameters.
Expire
01/01/2002
Quit
Clear
10-9
Quality Control
7. Input the expiration date.
Up to 10 digits can be input for the expiration date.
Note:
The operator must ensure the control blood is not beyond
expiration. The analyzer does not judge the expiration
dates entered in the QC file.
8. Press the [] or [] button.
When the [] button is pressed, the display changes from the first
QC file setting screen to the second screen. After the sixth screen,
pressing the [] button returns to the first screen. When the []
button is pressed, the display changes in reverse order.
Note:
There are six QC file setting screens.
Not Ready
Top
Set QC
File1
WBC
TARGET
LIMIT
6.7
X103/uL
RBC
X106/uL
HGB
0.0
0.0
HCT
0.0
0.0
MCV
0.0
0.0
fL
10. Input the TARGET value and the LIMIT value for each parameter.
Important!
There are 21 control parameters, and since not all of
these can be displayed on one screen, switch the
LCD screen by using the [] or [] button.
Save
Not Ready
Top
Set QC
TARGET
LIMIT
6.7
0.5
X103/uL
11. When the setting is completed, press the [Save] button. The quality
control setting storing confirmation dialog will appear.
Press the [OK] button to store the setting value, and either the X
first analysis start screen or the L-J analysis starting screen will
appear.
RBC
4.38
0.18
HGB
13.6
0.5
HCT
36.3
2.0
MCV
82.9
4.1
fL
X10 /uL
g/dL
Clear
g/dL
Clear
File1
WBC
10-10
Quality Control
Ready
Top
QC Analy
File1
WBC
TARGET
LIMIT
67
X103/uL
RBC
438
18
X106/uL
HGB
13.6
0.5
g/dL
HCT
36.3
2.0
Note:
To clear all of the set information, press the [Clear] button.
The deletion confirmation of quality control setting
message will be displayed.
MCV
82.9
4.1
fL
N
A
Change
settings?
Cancel
OK
Menu
Main
ID
1
Set a mixed
sample, and
Press [RUN].
Species (1)Dog
When the quality control has not been executed yet, the parameter
column is a blank.
RUN
select
QC
Result
Shutdown
Not Ready
Top
QC Analy
File
Lot ID
[1234567890]
[01/01/2002]
[1234567890]
[01/01/2002]
[1234567890]
[01/01/2002]
Ready
Top
QC Analy
Expire
[1]
File
Lot ID
[1234567890]
Expire
[01/01/2002]
Run
Settings
(1st analysis)
10-11
Quality Control
Not Ready
Top
Set QC
File[1]
Lot ID
1234567890
Select Input
parameters.
Expire
01/01/2002
Clear
Quit
Not Ready
Top
Set QC
File1
WBC
TARGET
LIMIT
6.7
X103/uL
RBC
X106/uL
HGB
0.0
0.0
HCT
0.0
0.0
MCV
0.0
0.0
fL
Clear
g/dL
Save
Note:
The QC file setting screens are consisted of sixth screens.
7. Read the each bar code in the Assay Sheet in the same way as 4.
10-12
Quality Control
Not Ready
Top
Set QC
File1
WBC
TARGET
LIMIT
6.7
0.5
X103/uL
8. When the setting is completed, press the [Save] button. The quality
control setting storing confirmation dialog will appear.
Press the [OK] button to store the setting value, and either the X
first analysis start screen or the L-J analysis-starting screen will
appear.
RBC
4.38
0.18
HGB
13.6
0.5
HCT
36.3
2.0
MCV
82.9
4.1
fL
X10 /uL
g/dL
Save
Clear
Ready
Top
QC Analy
File1
WBC
TARGET
LIMIT
67
X103/uL
RBC
438
18
X106/uL
HGB
13.6
0.5
g/dL
HCT
36.3
2.0
Note:
To clear all of the set information, press the [Clear] button.
The deletion confirmation of quality control setting message
will be displayed.
MCV
82.9
4.1
fL
N
A
Change
settings?
Cancel
OK
Menu
Main
ID
Species (1)Dog
Set a mixed
sample, and
Press [RUN].
RUN
select
Result
Shutdown
QC
10-13
Quality Control
Not Ready
Top
QC Analy
File
Lot ID
[1234567890]
[01/01/2002]
[1234567890]
[01/01/2002]
[1234567890]
[01/01/2002]
Ready
Important!
Before performing analysis, it is necessary to select a
control method and enter the control blood
information.
Top
QC Analy
[1]
File
Lot ID
[1234567890]
Expire
[01/0 1 / 2 0 0 2 ]
Run
Settings
(1st analysis)
Important!
Press the top of the sample position to open it
automatically. If you attempt to force it open it, the
instrument may be damaged.
Close the sample position once, and make sure
that there are no objects underneath the sample
position. If there is an object such as a pencil
under the sample position, it cannot be opened
sufficiently.
Caution!
Be sure to use the supplied sample adapter when
analyzing control blood. Failure to do so may result in
permanent damage to the instrument.
10-14
Quality Control
6. Mix the control blood in accordance with the package insert of the
control blood. (See Section 10.1 Control material).
Important!
The control blood (EIGHTCHECK-3WP) remains
usable for the specified period of days in the package
insert. If it is used after this point, abnormal count
values may result.
7. Open the control blood cap carefully to avoid splashing of blood. Set
the control blood into the control blood adapter, and close the sample
position.
Control Blood
10-15
Quality Control
X Control
Ready
Top
QC Analy
[1]
File
Lot ID
[1234567890]
Expire
[01/0 1 / 2 0 0 2 ]
Important!
The analysis starts, the status display reads
Aspirating.
When sample aspiration is completed, status display
Aspirating changes to Running.
When Running is displayed, the sample position
door can be opened and the control blood can be
removed safely.
Do not open the sample position while Aspirating is
displayed. If the sample position is opened while
displaying Aspirating, a correct analysis result will
not be obtained.
Run
Settings
Running
QC Analy
(1st analysis)
Top
Not Ready
QC Analy
Top
Next
To have the results from the first analysis printed out on the built-in
thermal printer, press the [Print] button.
Important!
The print format cannot be changed.
10-16
Quality Control
Ready
Top
QC Analy
[1]
File
Lot ID
[1234567890]
Expire
[01/01/2002]
Press the [Next] button to adopt data from the first analysis and
perform the second analysis. If the analysis results are not to be
adopted, you can perform a new analysis by pressing the [Back]
button.
In either case, remove the control blood, close the cap, and mix well.
Then, remove the cap again, set the control blood to the sample
position, and press the [Run] button.
Run
Settings
(2nd analysis)
Not Ready
Top
QC Analy
[1]
File
Lot ID
[1234567890]
Expire
[01/01/2002]
Run
Settings
QuitPrint
QC Analysis?
Not Ready
QC Analy
(2nd analysis)
OK
Cancel
Top
Back
When the second analysis is completed, the analysis results from this
analysis will be displayed in the X2 column on the analysis result
screen. The mean values of the analysis results from the first and the
second analyses will be displayed in the X column.
Use the [] or [] button to scroll the screen pages.
Press the [Print] button to print the results from the second analysis.
Press the [Quit] button to adopt the results of the two analyses, and
output the mean of the two analyses to the built-in thermal printer or
host computer, depending on the quality control data output settings.
If the results of the second analysis are not to be adopted, press the
[Back] button to perform a new second analysis.
Quit
Note:
The analysis results are saved to the stored data.
10-17
Quality Control
Example:
Sample IDs when quality control analysis was performed with file
No. 3 will be shown as the following:
Ready
Menu
Main
ID
1
Set a mixed
sample, and
Press [RUN].
Species (1)Dog
Error
ResultOK
QC03-1
X2 analysis results:
QC03-2
From the stored data screen, the result data can be printed out or
transferred to the host computer.
For parameters with a mean of the two analyses that is beyond the
control limit, a + is displayed in the Judgment column, and a - is
displayed if the mean is below the lower limit. Then an alarm sounds and
the QC error message is displayed. Press the [OK] button to turn off the
alarm.
RUN
Select
"QC (X) Error" occurred.
QC
X1 analysis results:
Shutdown
Important!
For details about actions to resolve the QC (X) error,
see Chapter 14. Troubleshooting.
Levey-Jennings Control
Ready
Top
QC Analy
[1]
File
Lot ID
[1234567890]
Expire
[01/0 1 / 2 0 0 2 ]
Run
Settings
Running
QC Analy
(2nd analysis)
Top
10-18
Quality Control
Not Ready
QC Analy
Top
Back
Next
Not Ready
Top
QC Analy
[1]
File
Lot ID
[1234567890]
Expire
[01/01/2002]
Important!
The print format cannot be changed.
When the [Top] button is pressed before defining the quality control
data, the quality control analysis discontinuance confirmation
message will be displayed.
Press the [OK] button to discard all analysis results, and complete
the quality control program. Then returning to the main screen.
Press the [Cancel] button to return to the analysis starting screen.
Then to continue the quality control analysis.
Press the [Quit] button to accept the analysis results, and output the
results to the built-in thermal printer or host computer, depending on
the quality control data output settings. If the results of the analysis
are not to be accepted, press the [Back] button to perform a new
analysis.
When performing re-analysis, remove the control blood, close the
cap, and mix well. Then, remove the cap again, set the control blood
in the sample position, and press the [Run] button.
Run
Settings
QuitPrint
QC Analysis?
(2nd analysis)
OK
Cancel
Note:
The analysis results are saved to stored data.
Example:
When quality control analysis was performed with file No. 3, the
data will be stored as:
Analysis results:
QC03
From the stored data screen for output, the result data can be printed
out or transferred to the host computer.
For parameters values that are beyond the control limit, a + is
displayed in the Judgment column, and a - is displayed if the value
is below the lower limit. Then an alarm sounds and the QC error message
is displayed. Press the [OK] button to turn off the alarm.
Important!
For details about actions to resolve the QC (L-J) error,
see Chapter 14. Troubleshooting.
10-19
Quality Control
Always record the results of quality control, and print a hard copy for
your records.
10-20
Calibration
11. Calibration
Calibration is performed to compensate for any reproducible
inaccuracies of the system. The HGB and/or HCT values are corrected
by a calibration value.
In automatic calibration, the reference values of 5 samples are entered.
The instrument determines the calibration value automatically by
analyzing those 5 samples.
In manual calibration, the calibration value must be calculated
according to a designated formula and entered.
The instrument needs to be calibrated:
Caution!
Calibration does not need to be performed at
specific intervals.
Follow your internal laboratory regulations for
performing calibration, as required.
Abnormal QC data due to instrument problems,
reagent degradation, or deterioration of control
blood cannot be eliminated by calibration.
Calibration is to compensate the analysis results
in a way, and all the analysis results will be
compensated to add a specific bias.
Note:
Upon calibration, run a QC using control bloods and verify
that the analysis results will not exceed the control limits.
For calibration, use five or more samples of fresh normal human blood
meeting the following conditions:
11-1
Calibration
Menu
Main
ID
1
Set a mixed
sample, and
Press [RUN].
Species (1)Dog
RUN
select
QC
Result
Shutdown
Not Ready
Top
Menu
Str.Data
Maint.
Settings
Calib.
Chg.Reag
11-2
Calibration
Not Ready
Top
Calib.
Note:
If a password has been set, the password input screen will
appear. Enter the password.
Enter Password.
Not Ready
Top
Calib.
Auto Calib.
Manual Calib.
Not Ready
Top
Auto Cal.
HGB(g/dL)
HCT(%)
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Select Calibration
parameters.
Next
Top
Auto Cal.
HGB(g/dL)
HCT(%)
14.2
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
4 Calbration
5
6
Select
parameters.
1
Quit
C
Ent.
Important!
Set 0 for the parameter that is not being calibrated.
Next
11-3
Calibration
Not Ready
Top
Auto Cal.
HGB(g/dL)
HCT(%)
14.2
38.4
13.8
35.5
14.5
35.5
14.1
36.3
13.6
37.2
Select Calibration
parameters.
Next
Not Ready
Top
Auto Cal.
HGB(g/dL)
1
14.2
HCT(%)
1
38.4
13.8
35.5
14.5
35.5
14.1
36.3
13.6
37.2
Select Calibration
parameters.
OK
Cancel
Next
Press the [OK] button to define target values, and display the
automatic calibration analysis starting screen.
Press the [Cancel] button to close the dialog, and the setting can
be continued.
* Press the [Top] button to display the setting cancel
confirmation dialog.
Press the [OK] button to return to the Main screen without
changing any setting, and the [Cancel] button to close the
dialog and then to continue the setting.
Performing analyses
Ready
Top
Auto Cal.
Data
HGB HCT
Current Cal.(%)
New Cal.(%)
Quit
Running
Target
Data
HGB HCT HGB HCT
14. 2 38. 4 14. 5 39. 2
13. 8 35. 5 14. 1 36. 1
14. 5 35. 5
14. 1 36. 3
13. 6 37. 2
Current Cal.(%)
New Cal.(%)
11-4
98. 5 100. 5
Run
Auto Cal.
1
2
3
4
5
Calib.(%)
HGB HCT
Top
Calib.(%)
HGB HCT
97. 9 98. 0
97. 9 98. 3
98. 7 103. 1
96. 6 101. 2
Set the sample in the sample position, and press the [Run] button to start
analysis.
Important!
When analysis starts, the status display reads
Aspirating.
When sample aspiration is completed, the status
display Aspirating changes to Running.
When Running is displayed, the sample position
door can be opened and the sample can be removed
safely.
Do not open the sample position while Aspirating is
displayed. If the sample position is opened while
displaying Aspirating, a correct analysis result will
not be obtained.
1
2
3
4
5
Target
HGB HCT
14. 2 38. 4
13. 8 35. 5
14. 5 35. 5
14. 1 36. 3
13. 6 37. 2
When all target values have been entered, the instrument is ready for
analysis.
Calibration
The automatic calibration analyzing screen will appear.
Important!
It is important to analyze the sample belonging to the
reference value. The values of the sample to be
analyzed are indicated by the underline cursor.
When an analysis was performed, its values are listed in the Data
column. In the Calib. (%) column, the calculated calibration values are
shown. When the analysis of more than one sample is completed, the
calibration value is calculated automatically for each analysis, and it is
displayed at the bottom of the Calib. (%) column.
The mean calibration value for each analysis and the current calibration
value are used to calculate and display the new calibration value.
Note:
During analysis, if the mean calibration value for each
analysis exceeds 105% or is less than 95%, or if the new
calibration value exceeds 120% or is less than 80%, an
alarm sounds and the automatic calibration error
confirmation dialog will appear.
Press the [Cancel] button, and analyze again.
Perform analysis for 5 samples.
Updating calibration values
Not Ready
Top
Auto Cal.
Target
HGB HCT
1 14. 2 38. 4
2 13. 8 35. 5
3 14. 5 35. 5
4 14. 1 36. 3
5 13. 6 37. 2
Data
Calib.(%)
HGB HCT
HGB HCT
14. 5 39. 2 97. 9 98. 0
14. 1 36. 1 97. 9 98. 3
14. 3 35. 9 101. 4 98. 9
14. 2 36. 2 99. 3 100. 3
13. 7 37. 5 99. 3 99. 2
Current Cal.(%)
New Cal.(%)
OK
Press the [OK] button to update the calibration value, and to return to
the Main screen.
Cancel
98. 7 103. 1
97. 9 102. 0
After completion of all analysis, press the [Quit] button. The automatic
calibration complete confirmation dialog will appear.
11-5
Calibration
Example:
Average of HGB values gained by the reference method = 14.0 g/dL
Average of HGB values gained by this instrument = 14.2 g/dL
Previous calibration value of HGB = 98.7%
Calculation of the new calibration value:
98.7 (14 /14.2) = 97.30% (97.3% rounded off)
The calibration value of HGB needs to be set at 97.3%.
Updating calibration values
Ready
Menu
Main
ID
Species (1)Dog
Set a mixed
sample, and
Press [RUN].
RUN
select
Result
Shutdown
QC
11-6
Calibration
Not Ready
Top
Menu
Str.Data
Chg.Reag
Calib.
Maint.
Settings
Not Ready
Top
Calib.
Note:
If a password has been set-up, the password input screen
will appear. Enter the password.
Enter Password.
Not Ready
Calib.
Top
Auto Calib.
Manual Calib.
Not Ready
Manu. Cal.
Top
Calib.
HGB
98.7
HCT
103.1
Select Calibration
parameter.
Quit
11-7
Calibration
Not Ready
Top
Manu. Cal.
Calib.
HGB
97.9
HCT
103.1
Ent.
Quit
Not Ready
Top
Manu. Cal.
Calib.
HGB
97.9
HCT
102.0
Note:
If nothing is input (space), the calibration value cannot be
defined.
6. After completion of entering the calibration values, press the [Quit]
button.
The manual calibration setting confirmation dialog will be displayed.
Select Calibration
parameter.
OK
Important!
A calibration error is displayed, if the mean calibration
value for each analysis exceeds 105% or is less than
95%, or if the new calibration value exceeds 120% or
is less than 80%.
The calibration value can be calculated using the
following formula.
Cancel
100
11-8
Calibration
Ready
Menu
Main
ID
1
Set a mixed
sample, and
Press [RUN].
Species (1)Dog
RUN
select
QC
Result
Shutdown
Not Ready
Top
Menu
Str.Data
Chg.Reag
Calib.
Maint.
Settings
Not Ready
Calib.
Top
Note:
If a password has been set-up, the password input screen
will appear. Enter the password.
Enter Password.
Not Ready
Calib.
Top
Auto Calib.
Manual Calib.
11-9
Calibration
11-10
Instrument Setup
Menu
Main
ID
1
Set a mixed
sample, and
Press [RUN].
Species (1)Dog
RUN
select
QC
Result
Shutdown
Not Ready
Top
Menu
Str.Data
Calib.
Chg.Reag
Maint.
Settings
Not Ready
Top
Settings
Note:
If a password has been set-up, the password input screen
will appear. Enter the password.
Enter Password.
12-1
Instrument Setup
Not Ready
Top
Settings
Host Output
System
Built-in Printer
Date/Time
Species
Network
Quality Control
Password Setting
User Information
Not Ready
Pirnt Output
Auto Pri.
Data
Format
Type1
Print Settings
Menu
Press the [Cancel] button to close the dialog, and the setting can
be continued.
Save
12-2
Instrument Setup
System setup
Note:
Any language change takes effect only after the next startup.
Basic instrument settings:
Parameter
Setting
Units
Language
Japanese / English
Setting changes made for this parameter become
valid the next time the main switch is turned ON.
Blood collection
tube
STANDARD / SARSTEDT
STANDARD:Standard sample tube
SARSTEDT:S-MONOVETTE (SARSTEDT)
sample tube
1/2/3
1: Quiet
2: Medium
3: Loud
Alarm sound
volume
12-3
Instrument Setup
Parameter
Setting
Timbre
ISBT128
Enable / Disable
When Enable is selected, the ISBT128 bar code
will be loaded as a sample ID number with up to
13 characters.
Important!
It is not possible to convert the stored data between
Dutch SI units and other units for the following 3
parameters: HGB, MCH, MCHC.
Do not use the stored sample data which was stored
before the setting change. In addition, renew settings for
reference limits, and for quality control TARGET and
LIMIT values.
Date/Time
The calendar and clock of the instrument can be set here.
12-4
Parameter
Setting
Format
Year
Month
Numeric input: 1 - 12
Day
Numeric input: 1 - 31
Hour
Numeric input: 0 - 23
Minute
Numeric input: 0 - 59
Note:
When time changes to summer or winter time, respectively,
the clock must be manually corrected accordingly.
Instrument Setup
Species specific settings
You can set the folloing parameters for each species.
Species
Parameter
OTHER1 - 13
Reference limits:
The upper and lower mark limits for the analysis results can be entered
here. If the analysis result exceeds the Upper Limit (UL), a + flag is
added next to that parameter. If the result is below the Lower Limit (LL),
a - flag is added. (See the table below for the initial settings.)
Parameter
LL (Lower Limit)
UL (Upper Limit)
WBC
RBC
HGB
0.0
0.0
HCT
0.0
0.0
MCV
0.0
0.0
MCH
0.0
0.0
MCHC
0.0
0.0
PLT
0.0
0.0
RDW-SD
0.0
0.0
RDW-CV
0.0
0.0
LYM% (W-SCR)
0.0
0.0
OTHR% (W-MCR)
0.0
0.0
EO% (W-LCR)
0.0
0.0
LYM# (W-SCC)
OTHR# (W-MCC)
EO# (W-LCC)
MPV
0.0
0.0
PDW
0.0
0.0
P-LCR
0.0
0.0
12-5
Instrument Setup
Note:
If LL or UL that satisfy the following conditions was entered
in the Patient Limit setting screen, a beep sounds and the
entering is canceled.
Correction values:
The correction values for HGB and HCT can be set here.
(See the table below for the initial settings.)
Parameter
Dog
Cat
Cattle
Horse
OTHER
1 - 13
HGB
100.2 %
100.3 %
97.6 %
87.2 %
100.0 %
HCT
92.4 %
78.3 %
89.7 %
92.5 %
100.0 %
Discrimination positions:
The discrimination positions for WBC, RBC, PLT can be set here.
(See the table below for the initial settings.)
Ready
Menu
Main
ID
Icon1
Icon2Set a mixed
sample, and
Press [RUN].
RUN
Icon3
Result
Shutdown
W-LD
54 fL
W-T1
132 fL
W-T2
144 fL
R-LD
10 fL
R-UD
250 fL
P-LD
1 fL
P-UD
20 fL
Parameter
Species
Icon1
Dog
Icon2
Cat
Icon3
Cattle
Icon4
Horse
Revised May 2006
QC
Other Icon4
OTHER1 - OTHER13
The species assigned on the icons in the main screen can be set here.
(See the table below for the initial settings.)
Species (1)Dog
Parameter
12-6
Instrument Setup
QC settings
Here the QC method and the data output method can be selected.
Selection
QC Method
Data Output
Selection
Unique naming
Host settings
The method of data output to the host computer can be set here.
For details, see Chapter 15. Technical Information.
Parameter
Setting
Connect
Automatic Output
Format
Transfer Rate
Data Length
Stop bit
Parity
Protocol
Transfer Interval
Choices: 0 s / 2 s / 3 s / 5 s / 7 s / 10 s / 15 s
RTS/CTS
ID Pad.
RDW
ASTM Rev.
12-7
Instrument Setup
Printer settings
The method of printing out analysis results can be set here. The print
header can be set as desired, using information such as the laboratory
name or instrument name. See Section 15.3 Print formats.
For entering numerals, see "Numerical keys dialog" in Chapter
"6.1 Screen display".
Parameter
Setting
Automatic Print
Format
Alphanumeric input:
Up to 16 digits of alphanumeric characters
Alphanumeric input:
Up to 16 digits of alphanumeric characters
Alphanumeric input:
Up to 16 digits of alphanumeric characters
Network settings
Address and other necessary settings can be made here for use of LAN
(Ethernet) port to communicate host computer. In addition, the MAC
address can be checked at this screen. For details, consult network
administrator at your laboratory.
Instrument side
Parameter
Setting
IP Address
Numeric input:
0 - 255 (common to all columns)
Default: 0.0.0.0
Netmask
Numeric input:
Default: 255.255.255.0
Default Gateway
Numeric input:
0 - 255 (common to all columns)
Default: 0.0.0.0
12-8
Instrument Setup
Host side
Parameter
Setting
IP Address
Numeric input:
0 - 255 (common to all columns)
Default: 0.0.0.0
Port Number
Calibration functions
Setting functions
When any of the above functions is selected, you will be prompted with
the password entry screen.
Key in the password and confirm with the [Ent.] button.
Important!
In case the password has been forgotten, contact
your Sysmex service representative.
Password setting procedure
Ready
Menu
Main
ID
Species (1)Dog
Set a mixed
sample, and
Press [RUN].
RUN
select
Result
Shutdown
QC
12-9
Instrument Setup
Not Ready
Top
Menu
Str.Data
Chg.Reag
Maint.
Settings
Calib.
Not Ready
Top
Settings
Note:
If a password has already been set-up, the password input
screen will appear. Enter the password. (No password is set
when the instrument is shipped; the password input screen
will not appear then.)
Enter Password.
Not Ready
Top
Settings
System
Date/Time
Species
Quality Control
User Information
Not Ready
Password
Host Output
Built-in Printer
Network
Password Setting
Print Settings
Top
New Password
Retype Password
Quit
12-10
Instrument Setup
Ready
Not Not
Ready
Top
Top
Password
Password
New
Password
New
Password
Important!
If the New Password and the Retype Password are
not identical, the password setting error message will
appear.
Re-enter the password into both boxes.
**********
**********
Retype
Password
Retype
Password
**********
**********
OKOK
Passwords
match.
Passwords
do do
notnot
match.
Not Ready
Top
Password
New Password
When the New Password and the Retype Password are identical, the
store setting data confirmation message will be displayed.
Press the [Cancel] button to cancel the setting changes, and close
dialog.
Press the [Top] button on the setting screen. The setting stop
confirmation dialog will appear.
Press the [OK] button to return to the Main screen without
changing the settings. Press the [Cancel] button to close the
dialog and continue the setting.
**********
Retype Password
**********
OK
Cancel
OK
Store
Setting
Passwords
dodata?
not match.
12-11
Instrument Setup
Menu
Main
ID
1
Set a mixed
sample, and
Press [RUN].
Species (1)Dog
RUN
select
QC
Result
Shutdown
Not Ready
Top
Menu
Str.Data
Chg.Reag
Maint.
Settings
Calib.
Not Ready
Top
Settings
Note:
If a password has been set-up, the password input screen
will appear. Enter the password.
Enter Password.
Not Ready
Top
Settings
System
Date/Time
Species
Quality Control
User Information
12-12
Biological risks
To avoid the risk of infections, wear protective
garments and gloves for all cleaning or maintenance
work. After completion of work, wash hands with
disinfectant.
As-needed maintenance
13-1
Menu
Main
ID
1
Set a mixed
sample, and
Press [RUN].
Species (1)Dog
RUN
select
QC
Result
Shutdown
Not Ready
Top
Menu
Str.Data
Chg.Reag
Calib.
Maint.
Settings
Not Ready
Top
Maint.
Auto Rinse
Status Display
Clog Removal
Calibration LCD
Drain TD Chamber
Clean Transducer
Setting Seq.
Clean W. Chamber
Drain Reagent
Running
Maint.
Vacuum
HGB Convert
Sensor
SV
Counter
Waste C.
Detector
Version
Top
0. 0130 MPa
2012 (255)
1 2 3 4 5 6 7 8
1 2 3 4 5 6 7 8 9 0
1 2 3 4 5 6 7 8 9 0
1 2 3 4 5 6 7 8 9 0
1 2 3 4 5 6 7 8 9 0
1105
727 (17/05/2000)
727 (17/05/2000)
00-00 (BIOS: 00-00)
Note:
When the [Run] button is pressed, analysis operation starts,
and the instrument status can be checked during operation.
Run
13-2
Caution!
If the instrument is used continuously without
performing the Shutdown sequence, protein build-up
of the internal parts may cause incorrect analysis
results or it may damage the instrument.
Not Ready
Top
Shutdown
Execute Cancel
Execute Shutdown.
Ready
Menu
Main
ID
Note:
If 24 hours have passed and Shutdown has not been
performed, a message appears prompting the operator
to perform Shutdown.
Species (1)Dog
Set a mixed
sample, and
Press [RUN].
RUN
select
QC
Result
Shutdown
Not Ready
Top
Shutdown
Execute Shutdown.
Note:
Once the Shutdown sequence is started, it cannot be
canceled anymore.
Execute Cancel
13-3
Top
Shutdown
Please wait.
3. Check that the Shutdown completion screen appears, and turn OFF
the main power switch on the right side of the instrument.
< Shutdown >
Remove tube from sample position
and turn OFF the power.
Restart
Menu
Start Up
When the main power switch is turned ON, and if either the counter
value exceeds 150, or if 2 weeks have passed since the last maintenance,
a message will appear prompting the operator to perform periodic
maintenance (transducer cleaning).
Press the [Cancel] button to continue start up without executing the
cleaning transducer operation. Until the transducer is cleaned, the
message is displayed at start-up.
When this message is displayed, perform the transducer cleaning
according to the following procedures.
Execute Cancel
Not Ready
Top
Maint.
Status Display
Clog Removal
Calibration LCD
Drain TD Chamber
Clean Transducer
Setting Seq.
Clean W. Chamber
Drain Reagent
Note:
Even when the above-mentioned message is not displayed,
cleaning transducer can be executed by pressing the [Maint.]
button of the menu screen, then pressing the [Clean
Transducer] button of the maintenance screen
Auto Rinse
13-4
Caution!
There is a potential that the detergent may corrode
the container. It is recommended to use a sample
tube made of glass or prepare the detergent
immediately before cleaning.
Important!
Push the top of the sample position to open it
automatically. If you attempt to force it, the
instrument may be damaged.
If there is an object such as a pencil under the
sample position, it cannot be opened sufficiently.
Close the sample position once, and make sure
that there are no objects underneath the sample
position.
13-5
Top
Start Up
Execute Cancel
Note:
When executing the transducer cleaning from the
maintenance menu screen, the transducer cleaning starting
screen will be displayed after the preprocessing sequence is
executed. Then press the [Execute] button.
Warning!
CELLCLEAN is a strong alkaline cleaning material. It
should not come in contact with skin or clothing. If it
happens, wash skin or clothing with plenty of water to
avoid injury or damage.
Running
Maint.
Please wait.
Top
13-6
Start up
Menu
Execute Cancel
Not Ready
When the main switch is turned ON, and if either the counter value
exceeds 1500, or if 3 months have passed since the last maintenance, a
message will appear prompting the operator to perform periodic
maintenance (waste chamber cleaning).
Top
Maint.
Auto Rinse
Status Display
Clog Removal
Calibration LCD
Drain TD Chamber
Clean Transducer
Setting Seq.
Clean W. Chamber
Drain Reagent
Note:
Even when the above-mentioned message is not displayed,
waste chamber cleaning can be executed by pressing the
[Maint.] button of the menu screen, then pressing the [Clean
W. Chamber] button of the maintenance screen.
Caution!
There is a potential that the detergent may corrode
the container. It is recommended to use a sample
tube made of glass or prepare the detergent
immediately before cleaning.
Important!
Press the top of the sample position to open it
automatically. If you attempt to force it open, the
instrument may be damaged.
If there is an object such as a pencil under the
sample position, it cannot be opened sufficiently.
Close the sample position once, and make sure
that there are no objects underneath the sample
position.
13-7
Not Ready
Menu
Start up
Execute Cancel
Running
Maint.
Warning!
CELLCLEAN is a strong alkaline cleaning material. It
should not come in contact with skin or clothing. If it
happens, wash skin or clothing with plenty of water to
avoid injury or damage.
6. After completion of waste chamber cleaning, the Main screen will
appear.
7. Remove the tube from the sample position.
Important!
When the cleaning is performed, the waste chamber
counter (number of cycles since last cleaning of
waste chamber) is automatically reset.
Revised March 2006
Please wait.
Menu
13-8
Ready
Menu
Main
Execute Auto Rinse to perform a background check, or when the unit has
been left idle without performing Shutdown.
1. Press the [Menu] button at the Ready status.
The Menu screen will appear.
ID
1
Set a mixed
sample, and
Press [RUN].
Species (1)Dog
RUN
select
QC
Result
Shutdown
Not Ready
Top
Menu
Str.Data
Chg.Reag
Calib.
Settings
Maint.
Not Ready
Top
Maint.
Status Display
Clog Removal
Calibration LCD
Drain TD Chamber
Clean Transducer
Setting Seq.
Clean W. Chamber
Drain Reagent
Not Ready
Top
Maint.
Auto Rinse
Execute Cancel
13-9
Maint.
Top
Please wait.
Running
Maint.
Top
Please wait.
Biological risks
Always wear protective garments and gloves when
handling the waste fluid. After work is completed,
wash hands with disinfectant.
When handling (disposing) the waste fluid, dispose it
appropriately in accordance to local laws and
regulations, which considers for the disposal of
medical waste and infectious waste.
If the "Drain Error" message appears and the waste bottle is full, follow
the procedure below to dispose the waste fluid.
13-10
Float switch
2. Dispose the waste fluid and clean the waste bottle out with water.
3. Insert the float switch into the empty waste bottle, and apply the cap.
Check that the tube is not bent.
Waste bottle
Not Ready
Menu
Help
Discard waste
Discard waste, and perform the error
recover sequence.
[Execute] Execute recovery sequence.
[Cancel] Back to the Prev. screen.
4. Press the [Execute] button on the error help screen. The waste
processing screen will appear, and the waste discharge operation will
be performed.
To return to the Main screen without performing the waste discharge
operation, press the [Cancel] button.
When the process is finished, the Main screen will appear.
Cancel
Caution!
Be sure to empty the waste bottle and insert the float
switch carefully, or the waste discharge operation
may fail.
Ensure that the waste bottle is secure and properly
connected before operating the instrument.
Waste fluid may discolor some materials.
If the waste fluid is spilt, wipe off with the damp cloth
immediately.
13-11
Biological risks
Always wear protective garments and gloves when
cleaning the sample tube adapter. After work is
completed, wash hands with disinfectant.
13-12
Warning!
CELLCLEAN is a strong alkaline cleaning material. It
should not come in contact with skin or clothing. If it
happens, rinse skin or clothing with plenty of water to
avoid injury or damage.
5. Set the cleaned sample tube adapter in the sample position.
6. When the adapter has been set, close the sample position.
Top
Help
Aperture Clog
Clog in the aperture is detected.
Execute Clog Removal Sequence
in case clog was not removed.
[Execute] Execute Clog Removal.
[Cancel] Back to the prev. screen
1. Press the [Execute] button on the "Aperture Clog" error help screen.
The clog removal screen will appear, and automatic clog removal
will be performed.
To return to the Main screen without performing automatic clog
removal, press the [Cancel] button.
When the process is finished, the Main screen will appear.
Cancel
Not Ready
Top
Maint.
Status Display
Clog Removal
Calibration LCD
Drain TD Chamber
Clean Transducer
Setting Seq.
Clean W. Chamber
Drain Reagent
Auto Rinse
Note:
Even when no error has occurred, automatic clog removal can
be performed by selecting [Maint.] from the Menu screen, and
then pressing the [Clog Removal] button on the maintenance
menu screen.
13-13
Ready
Menu
Main
ID
1
Set a mixed
sample, and
Press [RUN].
Species (1)Dog
RUN
select
QC
Result
Shutdown
Not Ready
Top
Menu
Str.Data
Chg.Reag
Calib.
Settings
Maint.
Not Ready
Top
Maint.
Status Display
Clog Removal
Calibration LCD
Drain TD Chamber
Clean Transducer
Setting Seq.
Clean W. Chamber
Drain Reagent
Auto Rinse
13-14
Menu
Maint.
Execute Cancel
Drain sample.
Running
Maint.
Top
Please wait.
5. Turn the main switch OFF, and wait for approx. 30 seconds.
Then disconnect the power cord.
Warning!
To avoid electrical shock, disconnect the power cord
before servicing.
(The main switch is not the disconnection device.)
13-15
13-16
Plug
Warning!
Do not open the detector cover while the main switch is
ON. There is a risk of personal injury by electric shock.
Cloth
Aperture
Warning!
CELLCLEAN is a strong alkaline cleaning material. It
should not come in contact with skin or clothing. If this
happens, wash skin or clothing with plenty of water to
avoid injury or damage.
11. Replace the transducer chamber plug.
Caution!
Reattach the transducer chamber plug securely.
Otherwise, reagent leakage might occur, which
causes a short circuit or electrical shock.
13-17
Caution!
Securely close the detector cover and the right
side cover. Failure to do so may result in damage
to the instrument.
13-18
Biological risks
Always wear protective garments and gloves when
draining reagents. After completion of work, wash
hands with disinfectant.
1. Remove the caps from pocH-pack D and pocH-pack LVD. Pull the
container spout kits straight out to remove them.
Container
spout kits
pocH-pack D
or
pocH-pack LVD
Caution!
Place the removed container spout kits on top of a
clean cloth, or inside a plastic bag, and take care to
prevent dust or other substances from adhering to
them.
Ready
Menu
Main
ID
1
Set a mixed
sample, and
Press [RUN].
Species (1)Dog
RUN
select
QC
Result
Not Ready
Menu
Shutdown
Top
Chg.Reag
Calib.
Settings
Maint.
Str.Data
13-19
Top
Maint.
Auto Rinse
Status Display
Clog Removal
Calibration LCD
Drain TD Chamber
Clean Transducer
Setting Seq.
Clean W. Chamber
Drain Reagent
Not Ready
Top
Maint.
Execute Cancel
Drain reagent.
Running
Maint.
Top
Please wait.
6. Check that the drain reagent completion screen is displayed, and turn
OFF the main switch of the instrument.
< Drain Reagent >
Reagent has been drained.
7. Remove the waste bottle cap. Pull the float switch straight out to
remove it.
Note:
The instrument will be primed automatically the next time
it is started up.
Also it can be primed by performing Setting Sequence in
the maintenance menu.
13-20
Menu
Main
ID
1
Set a mixed
sample, and
Press [RUN].
Species (1)Dog
RUN
select
QC
Result
Shutdown
Not Ready
Top
Menu
Str.Data
Chg.Reag
Calib.
Settings
Maint.
Not Ready
Top
Maint.
Auto Rinse
Status Display
Clog Removal
Calibration LCD
Drain TD Chamber
Clean Transducer
Setting Seq.
Clean W. Chamber
Drain Reagent
4. Press the center of + mark on the screen each time the + mark is
displayed.
< Calibration LCD >
The + mark will appear on the LCD in the following order: at the
center, the upper left, the lower left, the lower right, and the upper
right. After completion of all + marks input, the calibration LCD
confirmation dialog screen will appear.
13-21
Press the [OK] button to apply the calibration, and the Main screen
will appear.
OK
Calibration LCD?
Cancel
Quit
Calibration Error!
Note:
If the input position was outside a regulated range, the
calibration error message will appear, and the
calibration will be discontinued.
When calibration is performed and a calibration error
occurs frequently, there may be a problem with the
touch panel. Contact your Sysmex service
representative.
Ready
Menu
Main
ID
Species (1)Dog
Set a mixed
sample, and
Press [RUN].
RUN
select
Result
Shutdown
QC
13-22
Top
Menu
Str.Data
Chg.Reag
Calib.
Settings
Maint.
Not Ready
Top
Maint.
Auto Rinse
Status Display
Clog Removal
Calibration LCD
Drain TD Chamber
Clean Transducer
Setting Seq.
Clean W. Chamber
Drain Reagent
Not Ready
Top
Maint.
Setting Seq.
Check tubes connecting reagents.
Press [execute] button.
Execute Cancel
Running
Maint.
Note:
The instrument will not perform an Auto Rinse in the next
time it is started up after completion of the setting sequence
setting.
Top
Please wait.
13-23
Error dialog
Reagent to be replaced
Replace pocH-pack D
pocH-pack D
pocH-pack LVD
Caution!
Leave the reagents at room temperature (15 30C) for at least 24 hours or longer before using.
If a reagent that has arrived recently is used, a
correct analysis result will not be obtained.
pocH-pack LVD
90 days
Revised May 2006
pocH-pack D
13-24
3. Remove the cap from the empty reagent bottle. Pull the container
spout kit straight out to remove it.
4. Insert the container spout kit immediately straight into the new
reagent bottle, then tighten the cap.
pocH-pack D
or
pocH-pack LVD
Ready
Menu
Main
ID
Caution!
Take care not to touch the pipe that enters the
reagent with your hands, or to allow dust or other
substances to adhere to them. If such substances
adhere to the pipe, first wash the substance off with
reagent before attaching the container spout kit.
Failure to do so may prevent correct analysis.
Take sufficient care to prevent the reagent from
spilling. If the reagent spills, immediately wipe it off
with a damp cloth or similar material. The reagent
may cause discolor the floor.
1
Set a mixed
sample, and
Press [RUN].
Species (1)Dog
RUN
select
QC
Result
Shutdown
Not Ready
Top
Help
Replace pocH-pack D
pocH-pack D Error.
Replace container pocH-pack D.
[Exec.] Reaspirating pocH-pack D.
[Cancel] Back to the prev. screen.
ERROR CODE : XXXXX.XXXXX.XXXXX
Execute Cancel
Not Ready
Menu
Str.Data
Chg.Reag
Calib.
Settings
Maint.
13-25
Top
Chg. Reag.
pocH-pack LVD
Not Ready
Top
Chg. Reag.
Execute Cancel
Running
Maint.
Top
Please wait.
13-26
2. Push the lugs of the both sides of the fuse holder inside, and remove
the fuse holder.
Warning!
For the continued protection against risk of fire,
replace only with a fuse of the specified type and
current ratings.
13-27
Caution, Hot!
The printer head becomes hot. Use caution.
Push
Printer cover
Caution!
Static electricity may damage the printer head. Do not
touch with hands.
2. Remove any remaining paper. Insert new printer paper, and close the
printer cover so that it catches the paper.
Important!
Set the paper straight and in the correct direction.
If inserted at an angle, the paper may become
jammed.
The printer cover must be closed securely until a
"click" sound is heard. If the cover is not closed
completely, an error will occur.
Thermal head
13-28
Product name
Purpose
024-0971-4
pocH-pack D
Diluent
054-1821-2
pocH-pack LVD
Lyse reagent
834-0162-1
CELLCLEAN(CL-50)
Detergent
Product code
Product name
Reference section
041-0031-5
041-0061-7
CL6040 (5 rolls)
041-0051-0
041-0041-2
WASTE BOTTLE
ASSY POCH
(C2/WITHOUT FSW)
Consumables
13-29
13-30
Troubleshooting
14. Troubleshooting
If the instrument shows any signs that indicate a malfunction during
operation, be sure to first check 14.1 General faults, instrument failure
on the following pages. If the corresponding item is not found, or if the
procedure listed under Action does not eliminate the signs of trouble,
contact your Sysmex service representative.
Other errors are indicated by a beep and a message is then displayed
on the LCD screen.
If an error affects only a specific analysis result, it will be marked by
a flag.
Warning!
Disconnect the power cord before opening the
instrument.
Otherwise there is a risk of personal injury by
electrical shock and possible damage to the
instrument.
Important!
If you are unable to rectify the error, contact your
Sysmex service representative for assistance. Before
doing so, make a note of the exact ERROR CODE in
the Help screen to enable your service representative
to provide assistance quickly.
Important!
In case of a power failure during operation, turn the
main power switch to [O] OFF position.
14-1
Troubleshooting
Action
A memory error may have occurred. Turn the main switch OFF, wait 1 to
2 minutes, then turn the main power switch ON again.
Turn the main power switch OFF and wipe off the leaked fluid.
Biological risks
Wear protective garments and gloves when working. After
completion of work, wash hands with disinfectant.
14-2
Troubleshooting
14-3
Troubleshooting
(page)
Aperture Clog ..................................................................................... 14-9
Blank Error ......................................................................................... 14-9
Drain Error ......................................................................................... 14-8
HC ACK Timeout ............................................................................ 14-14
HC Buffer Full.................................................................................. 14-13
HC NAK Retry................................................................................. 14-14
HC OFF-line..................................................................................... 14-14
HGB Error ........................................................................................ 14-10
LAN Buffer Full............................................................................... 14-13
LAN no Response ............................................................................ 14-14
No Printer Paper ............................................................................... 14-13
Piercer MC Error ................................................................................ 14-8
Piercer MT Error ................................................................................ 14-8
PinchV1 MC Error ............................................................................. 14-8
PinchV2 MC Error ............................................................................. 14-8
PinchV1 MT Error.............................................................................. 14-8
PLT Noise Error ............................................................................... 14-12
PLT Smpg Error.............................................................................. 14-10
PPMC Cont. Error ............................................................................ 14-12
Print Buffer Ful ................................................................................ 14-13
Printer Error...................................................................................... 14-13
QC Data Error .................................................................................. 14-11
QC (L-J) Error .................................................................................. 14-10
QC (X) Error .................................................................................... 14-10
RAM Error ....................................................................................... 14-11
RBC Noise Error .............................................................................. 14-12
RBC Smpg Error............................................................................. 14-10
R-Cover Open................................................................................... 14-12
Replace pocH-pack D......................................................................... 14-7
Replace pocH-pack LVD ................................................................... 14-7
ROM Error ....................................................................................... 14-11
Room Temp. (H) ................................................................................ 14-9
Room Temp. (L)................................................................................. 14-9
Settings Error.................................................................................... 14-11
Settings Seq. Err ............................................................................... 14-12
Stored Error ...................................................................................... 14-11
Syringe MC Error............................................................................... 14-8
Syringe MT Error ............................................................................... 14-8
Tube holder Error. ............................................................................ 14-11
Vacuum Error ..................................................................................... 14-7
Waste C. Error.................................................................................... 14-7
WBC Noise Error ............................................................................. 14-12
WBC Smpg Error............................................................................ 14-10
14-4
Troubleshooting
Error massage index by function
Pressure errors
(page)
Vacuum Error......................................................................................14-7
Chamber errors
Waste C. Error.....................................................................................14-7
Replace pocH-pack D .........................................................................14-7
Replace pocH-pack LVD ....................................................................14-7
Drain Error ..........................................................................................14-8
Motor errors
Syringe MC Error................................................................................14-8
Syringe MT Error ................................................................................14-8
Piercer MC Error.................................................................................14-8
Piercer MT Error .................................................................................14-8
PinchV1 MT Error ..............................................................................14-8
PinchV1 MC Error ..............................................................................14-8
PinchV2 MC Error ..............................................................................14-8
Transducer errors
Aperture Clog......................................................................................14-9
Temperature errors
Room Temp. (H) .................................................................................14-9
Room Temp. (L)..................................................................................14-9
Analysis errors
Blank Error..........................................................................................14-9
HGB Error .........................................................................................14-10
QC (L-J) Error...................................................................................14-10
PLT Smpg Error...............................................................................14-10
RBC Smpg Error..............................................................................14-10
WBC Smpg Error.............................................................................14-10
QC (X) Error .....................................................................................14-10
Memory errors
Stored Error .......................................................................................14-11
Settings Error ....................................................................................14-11
ROM Error ........................................................................................14-11
RAM Error ........................................................................................14-11
QC Data Error ...................................................................................14-11
14-5
Troubleshooting
Other errors
(page)
Tube holder Error ............................................................................. 14-11
Settings Seq. Err ............................................................................... 14-12
R-Cover Open................................................................................... 14-12
PLT Noise Error ............................................................................... 14-12
PPMC Cont. Error ............................................................................ 14-12
RBC Noise Error .............................................................................. 14-12
WBC Noise Error ............................................................................. 14-12
Printer errors
Print Buffer Ful ................................................................................ 14-13
No Printer Paper ............................................................................... 14-13
Printer Error...................................................................................... 14-13
External output errors
HC OFF-line..................................................................................... 14-14
HC NAK Retry................................................................................. 14-14
HC Buffer Full.................................................................................. 14-13
HC ACK Timeout ............................................................................ 14-14
LAN Buffer Full............................................................................... 14-13
LAN no Response ............................................................................ 14-14
14-6
Troubleshooting
14.3 Error messages, possible causes and actions to resolve the error
Vacuum Error
Possible cause
Action to resolve
the error
Special notes, if
error remains
Waste C. Error
Possible cause
Action to resolve
the error
Special notes, if
error remains
Replace pocH-pack D
Replace pocH-pack LVD
Possible cause
Action to resolve
the error
Special notes, if
error remains
14-7
Troubleshooting
Drain Error
Possible cause
Action to resolve
the error
Special notes, if
error remains
Piercer MC Error
PinchV1 MC Error
PinchV2 MC Error
Syringe MC Error
Possible cause
Action to resolve
the error
Special notes, if
error remains
Piercer MT Error
Syringe MT Error
Possible cause
Action to resolve
the error
Special notes, if
error remains
PinchV1 MT Error
Operation of driving motor is abnormal. The tube is stuck or broken.
Action to resolve
the error
Special notes, if
error remains
Possible cause
14-8
Troubleshooting
Aperture Clog
Possible cause
Transducer chamber aperture is clogged, or air bubbles have entered the transducer
chamber.
Action to resolve
the error
Special notes, if
error remains
Ready for next analysis, however, the next sample may be impaired.
Action to resolve
the error
Special notes, if
error remains
The * sign (indicates the result is low in reliability) will appear on the left side of
analysis results.
If the temperature in the detector block is too high or low, perform shutdown of the
instrument. Leave the instrument at an appropriate room temperature for some
time, then turn the main switch ON again.
Possible cause
Action to resolve
the error
Special notes, if
error remains
Ready for next analysis, however, the next sample may be impaired.
Blank Error
14-9
Troubleshooting
HGB Error
Possible cause
Action to resolve
the error
Press [Execute] button to clear the error, and the Clean Transducer is executed.
Special notes, if
error remains
Ready for next analysis, however, the next sample may be impaired.
QC (L-J) Error
QC (X) Error
Possible cause
Action to resolve
the error
Special notes, if
error remains
Ready for next analysis, however, the following sample results may be incorrect.
Possible cause
Action to resolve
the error
Special notes, if
error remains
14-10
Ready for next analysis, however, the next sample may be impaired.
Troubleshooting
QC Data Error
Setting Error
Stored Error
Possible cause
An error occurred in the set values of the stored data or QC data due to momentary
power failure, sudden electric noise interference, etc.
Action to resolve
the error
Special notes, if
error remains
Follow the instructions on the screen to repair the data. Then restart the
instrument.
If repair is not successful, then initialize the data.
When the instrument is initialized, all stored data is deleted. If settings have been
initialized, make settings again.
If either repair or initialize is successful, the program will be started.
RAM Error
ROM Error
Possible cause
CPU malfunction due to momentary power failure, sudden electric noise interference,
etc.
Action to resolve
the error
Special notes, if
error remains
The sample position was opened while the instrument was operating.
Action to resolve
the error
After closing the door, press the [Execute] button to clear the error, and the recovery
sequence is executed.
Special notes, if
error remains
At the time the reagent was aspirated inside the instrument (priming), a motor error,
chamber error, sample position error, or right side cover error occurred.
Action to resolve
the error
Special notes, if
error remains
Press the [Execute] button, then turn OFF the main switch. Check the tubes
connecting the reagents and waste bottle, then restart the instrument.
Press the [Cancel] button to return to the previous LCD screen.
14-11
Troubleshooting
R-Cover open
Possible cause
Action to resolve
the error
After closing the right side cover, press the [Execute] button to clear the error, and the
recovery sequence is executed. If the recovery process is completed correctly, then
Auto Rinse and background check are performed in sequence, and the screen returns to
the Main screen.
Special notes, if
error remains
Action to resolve
the error
Special notes, if
error remains
Ready for next analysis, however, the next sample may be impaired.
Action to resolve
the error
Special notes, if
error remains
HC Buffer Full
LAN Buffer Full
Print Buffer Ful
Possible cause
Action to resolve
the error
Special notes, if
error remains
14-12
Troubleshooting
No Printer Paper
Possible cause
Action to resolve
the error
Special notes, if
error remains
After refilling paper in the built-in thermal printer, press [Retry] button to clear the
error, and the data under printing will be printed from the beginning by one sample
(see Chapter 13.16).
After refilling paper in the built-in thermal printer, press [Cancel] button to cancel
the data under printing, also discard the waiting data, and the error is cleared.
Printer Error
Possible cause
Action to resolve
the error
Check if the paper is set correctly and close the cover (see Chapter 13.16).
After checking the built-in thermal printer, press [Retry] button to clear the error,
and the data under printing will be printed from the beginning by one sample.
After checking the built-in thermal printer, press [Cancel] button to cancel the data
under printing, also discard the waiting data, and the error is cleared.
Special notes, if
error remains
HC ACK Timeout
HC Off-line
HC NAK Retry
Possible cause
Action to resolve
the error
Special notes, if
error remains
14-13
Troubleshooting
LAN no Response
Action to resolve
the error
Special notes, if
error remains
Possible cause
14-14
Troubleshooting
Ready
Menu
Main
ID
1
Set a mixed
sample, and
Press [RUN].
Species (1)Dog
RUN
select
QC
Result
Shutdown
Not Ready
Top
Menu
Str.Data
Chg.Reag
Calib.
Maint.
Settings
Not Ready
Top
Maint.
Auto Rinse
Status Display
Clog Removal
Calibration LCD
Drain TD Chamber
Clean Transducer
Drain Reagent
Clean W. Chamber
14-15
Troubleshooting
14-16
Technical Information
Operating
Storage and
Transportation*
+15C to +30C
(+23C would be ideal)
-10C to + 60C
30% to 85%
95% or less
(Non condensing/Keep dry)
Relative humidity
Main Unit
dimensions
Power supply
Power consumption
150 VA or less
Analysis Parameters
see Chapter 1.3 Abbreviations and units used throughout this manual
Display range
Background limits
10 ( 103/L)
Analysis time
Approx. 125 seconds (After starting an analysis until displaying the analysis report)
Analysis principle
Class of electric
shock protection
measures
Class I Equipment
EMC characteristics
15-1
Technical Information
Safety
Reproducibility
(With 95% reliability
limit)
LYM#
30.0% or less
30.0% or less
OTHR#
EO# ( 0.2
3.5% or less
2.0% or less
2.0% or less
2.0% or less
2.0% or less
2.0% or less
2.0% or less
10.0% or less
15.0% or less
103/L)
50.0% or less
30.0% or less
OTHR%
15.0% or less
EO% ( EO 2%)
50.0% or less
RDW-SD
4.0% or less
RDW-CV
6.0% or less
12.0% or less
5.0% or less
20.0% or less
15-2
Technical Information
Linearity
RBC
HGB
HCT
1 (HCT%) or less, or
5% or less
PLT
(RBC < 7.00 106/L)
10 - 1200 (103/L)
10 (103/L) or less, or
10% or less
WBC
(RBC < 7.00 106/L)
(for dog, cattle or horse
blood)
WBC
(RBC < 7.00 106/L)
(for cat blood)
Carry-over
WBC
RBC
HGB
HCT
PLT
Consumables
Aspirated sample
volume
approx. 15 L
Number of analyses
that can be
performed with 1
reagent bottle
pocH-pack D: Approximately 30
3% or less
1.5% or less
1.5% or less
1.5% or less
5% or less
Note:
The abnormal sample conditions listed here are known to affect test results. The majority of
the listed sample conditions are not measured quantitatively because these conditions vary
due to animal species, diagnosis, age, medications, etc. Laboratories can perform studies in
order to show how their specific animal species are affected by various conditions.
15-3
Technical Information
Potential Detection:
Cold agglutinins
Potential Detection:
Cold agglutinins
Microcytosis (severe)
Low MCV
Potential Detection:
Cold agglutinins
Potential Detection:
Leukocytosis
Very high white blood cell count with low red blood
cell count present
Potential Detection:
Platelet aggregation
Giant platelets
15-4
Cause:
Potential Detection:
Low MCV
Technical Information
Species
(1)Dog
Manual Ana.
[S][W][R][P]
Species
Type 3
Species
(1)Dog
Manual Ana.
[S][W][R][P]
(1)Dog
Manual Ana.
[S][W][R][P]
LYM%
OTHR%
EO%
LYM#
OTHR#
EO#
LYM%
OTHR%
EO%
LYM#
OTHR#
EO#
Type 2
15-5
Technical Information
Part name
Explanation
281-9576-1
TOUCH65-PRO
265-9151-5
CAB320-DIN8
281-9577-5
SPC-Touch 65/90
Desk Holder
No.
15-6
Technical Information
Connection procedure
1. Turn the main switch OFF.
2. Insert the connection cable into the bar code reader unit.
3. Insert the other end of the connection cable into the connector port
labeled BR on the right side of the instrument.
Press the trigger switch and check that the red LED is ON.
Trigger switch
15-7
Technical Information
Bar code reader settings
Make settings according to the menu sheet which is provided with the bar code reader.
Communications parameters were set at the time the unit was shipped from the factory. They do not need
to be set.
Make settings to match the bar code label which you use.
Set the ID character and check digit to Not transmit.
Hardware specifications
1. Symbologies which can be read: UPC-A/E, CODE39, CODE128, ITF, NW-7 (CODABAR)
2. Decoder: Built-in
3. Interface: RS-232C
4. Connector: DIN 8P
5. Power input: 5 V DC 5%
6. Connector pin arrangement
No.
Signal name
Signal direction
Reader Analyzer
Reader Analyzer
Reader Analyzer
Reader Analyzer
NC (Not Connected)
Reader Analyzer
SG (0 V)
Reader Analyzer
+5 V (+5 V)
Reader Analyzer
Software
1. Data communication protocol
E
T
X
Order of transmission
15-8
S
T
X
Technical Information
2. Data transmission parameters
Parameter
Setting value
Baud rate
9600 bps
Data length
8 bits
Stop bit
1 bit
Parity
None
RTS/CTS
Valid
Transfer sequence
No protocol
Check digit
Not transmit
ID character
Not transmit
Preamble
STX (02H)
Postamble
ETX (03H)
Warning!
If the sample bar code is used, use a check digit whenever possible.
If a check digit is not used, the chances of the bar code being misread increase.
Symbology
ITF
Check digit
Number of digits
None
Modulus 10
None
Modulus 11
Weighted modulus 11
Modulus 16
15-9
Technical Information
Symbology
Check digit
CODE39
Number of digits
None
Modulus 43
CODE128
Modulus 103
JAN-8
Modulus 10
JAN-13
Modulus 10
Min. 0.20 mm
Narrow: Wide
2.2 - 3.0
0.85 - 1.17
The analysis method conforms to JIS (Japanese Industrial Standards) X0501, Section 5.3: Optical
Characteristics of Bar code Symbols.
Standard: PCS value 0.45
4. Surface reflection
A laminated label cannot be read.
5. Irregularity and Roughness of Printing
Enlarging a single bar from a bar code with a microscope shows something like the figure below.
MAX
MIN
Bar element
S=
MAX - MIN
100%
MAX
15-10
Technical Information
6. Bar code label dimensions
Bar height
Space:
Min. 2.5 mm or 10 largest module value
Effective bar code width: Max. 48 mm (Optimum: 40 mm or less)
Bar height:
Min. 20 mm
7. Check digit
A check digit can be added to further increase the reliability of the ID number which is read.
Following is an example of the methods used to calculate the check digit of modulus 11 and weighted
modulus 11 for a sample ID number of 258416.
1) Modulus 11
(1) A weight is assigned to each digit.
Weight
14
30
40
16
12
(2) The results of multiplication are all added together. The result is S.
S = 14 + 30 + 40 +16 + 3 + 12 = 115
(3) A remainder is found by dividing S by 11. The complement of this remainder is then found.
The 11-complement becomes the check digit value to be added.
115 / 11 = 10 (remainder = 5)
11 - 5 = 6 The check digit is 6.
All alphabet and symbol characters other than numbers 0 to 9 are considered for calculation to be 0.
If the remainder is 0 when S is divided by 11, or if the result of check-digit calculation is 10, then the
check digit is 0.
2) Weighted modulus 11
With weighted modulus 11, there are two sets of weights for each digit. The check is performed first
using the first set of weights. If the result is 10, then the check is performed again using the second set
of digits. The result is assured to be 0 to 9. Except for the difference in weights, the calculation
method is exactly the same as for modulus 11.
W12
W11
W10
W9
W8
W7
W6
W5
W4
W3
W2
W1
First Set:
10
Second Set:
10
15-11
Technical Information
Weight
16
20
40
12
12
(2) The results of multiplication are all added together. The result is S.
S = 16 + 20 + 40 + 12 + 6 + 12 = 106
(3) A remainder is found by dividing S by 11. The complement of this remainder is then found.
The 11-complement becomes the check digit value to be added.
106 / 11 = 9 (remainder = 7)
11 - 7 = 4 The check digit is 4.
All alphabet and symbol characters other than numbers 0 to 9 are considered for calculation to be 0.
If the remainder is 0 when S is divided by 11, or if the result of check-digit calculation is 0, then the
check digit is 0.
Note:
The weight of digits 13 to 15 is 0.
15-12
Technical Information
or
Note:
To utilize the host computer output interface, install software compatible with
pocH-100iV Diff onto the computer to enable data reception.
Serial communications
Hardware
(1) Connector
Signal name
Signal direction
1
2
Receive Data
(RxD)
Transmit Data
(TxD)
(DTR)
Signal Ground
(SG)
(DSR)
Request To Send
(RTS)
Clear To Send
(CTS)
15-13
Technical Information
(3) Communication format
Asynchronous full duplex mode is used. (The underlined items are initial settings.)
Setting
Setting type
1200 bps / 2400 bps / 4800 bps / 9600 bps / 19200 bps
Baud rate
Data length
7 bits / 8 bits
Stop bit
1 bit / 2 bits
Parity
Protocol
Class A / Class B
Interval
0 s / 2 s / 3 s / 5 s / 7 s / 10 s / 15 s
RTS/CTS
Data signal
Control signal
+3 V or more
ON
-3 V or less
OFF
Software
(1) Communication format
1)
Code
Data: ASCII code
Control code: [STX], [ETX], [ACK], [NAK]
2)
Text structure
[STX] is sent at the start of the data, and [ETX] is sent at the end of the data.
S
T
X
E
T
X
Order of transmission
3)
Communication protocol
Class A
This is unidirectional transmission which does not utilize responses from the host
computer.
15-14
There are two classes of communication protocols that can be selected according to the system
status.
Technical Information
Class B
Confirmation responses ([ACK], [NAK]) are received from the host computer in response
to the transmitted data. Data is transmitted alternately between the instrument and host
computer.
Host computer
pocH-100iV Diff
4)
[NAK]
Transmission errors
If an error occurs during transmission, transmission is interrupted and an error message is
displayed. The operator can select whether to retransmit ([OK] button) or cancel transmission
([CANCEL] button). A transmission error occurs in the following cases.
Host computer is off-line.
Control signal DSR is OFF.
There is no response from the host computer within 15 seconds after data is sent (Class B
only).
The host computer sends anything other than [ACK] or [NAK] after data is sent (Class B
only).
[NAK] is sent in response to the fourth transmission of the data (Class B only). (The
instrument automatically repeats data transmission a maximum of 3 times when it receives
[NAK].)
5)
Host computer
In normal analysis
In QC analysis
QC data (A)
Analysis data includes the date, sample number, analysis data, flags, and other information.
QC data is X or L-J data.
Settings for connected devices are changed in the setting program.
15-15
Technical Information
LAN communication
Hardware
The physical layer and data link layer of this port conform to IEEE802.3.
1. Connector
The instrument connector utilizes a twisted-pair cable (UTP cable category 5) for Ethernet use.
(Connector: RJ-45)
2. Connector signals
Pin No.
Signal name
Signal direction
TD+
TD-
RD+
NC
NC
RD-
NC
NC
Software
1. Network layer/ transport layer
Conforms to the TCP/IP protocol.
2. Session layer
The connection is made with the host computer as the server and the instrument as the client.
They are connected at start-up.
If the connection fails, a connection error occurs. The connection is attempted again after the
operator has corrected the error using the touch panel.
3. Presentation layer
ASCII code is used for the transmission data. [STX] is added to the start of the data, and [ETX] is
added to the end of the data.
E
T
X
Order of transmission
15-16
S
T
X
Technical Information
Format
The same format is output through serial or LAN port, and includes 4 types of output formats:
pocH format
KX-21N format
ASTM format
K-1000 format
pocH format
pocH format includes an Analysis data format for output of sample data, and a QC data format for
output of QC data. Each has different text length and contents. (They are identified by the sample
distinction code.)
If the length of the transmitted data, including [STX] and [ETX], exceeds 256 bytes, it is divided into
multiple text blocks for transmission. The divided text blocks are sent in order, beginning from the head,
and no other data is mixed in between the blocks. The text sequence is expressed by text distinction code
II numerals.
Analysis data format
Parameter
No. of characters
Format
STX
(02H)
Fixed character: D
Text No.: 1
Fixed character: U
Instrument ID
40
Year
Month
Day
Analysis information
Sample ID
15
AB-12345, 0000000AB-12345
Particle distribution
analysis information
Species
A - Q
Example: Dog:A, Cat:B, OTHER10:J
WBC
15-17
Technical Information
Parameter
No. of characters
Format
RBC
HGB
Same as above
HCT
Same as above
MCV
Same as above
MCH
Same as above
MCHC
Same as above
PLT
Same as above
LYM% (W-SCR)
Same as above
OTHR% (W-MCR)
Same as above
EO% (W-LCR)
Same as above
LYM# (W-SCC)
Same as above
OTHR# (W-MCC)
Same as above
EO# (W-LCC)
Same as above
RDW-SD
Same as above
RDW-CV
Same as above
PDW
Same as above
MPV
Same as above
P-LCR
Same as above
ETX
(03H)
Total 171
Parameter
No. of characters
Format
STX
(02H)
Fixed character: D
Text No.: 2
100
100
ETX
(03H)
Total 204
15-18
No. of characters
Format
STX
(02H)
Fixed character: D
Text No.: 3
80
Parameter
Technical Information
Parameter
No. of characters
Format
WBC LD
WBC T1
WBC T2
WBC UD
RBC LD
Same as above
RBC UD
Same as above
PLT LD
Same as above
PLT UD
Same as above
RESERVED
128
ETX
Total 228
QC data format
Parameter
No. of characters
Format
STX
(02H)
Fixed character: D
Text No.: 1
Fixed character: C
Instrument ID
40
Lot ID
10
QC method
X control: X, L-J control: L
Year
Month
Day
Hour
Minute
Data ID
RESERVED
RESERVED
WBC
LYM%
Same as above
OTHR%
Same as above
15-19
Technical Information
Parameter
No. of characters
Format
EO%
Same as above
LYM#
Same as above
OTHR#
Same as above
EO#
Same as above
RBC
Same as above
HGB
Same as above
HCT
Same as above
MCV
Same as above
MCH
Same as above
MCHC
Same as above
RDW-SD
Same as above
RDW-CV
Same as above
PLT
Same as above
PDW
Same as above
MPV
Same as above
P-LCR
Same as above
W-SMV
Same as above
W-LMV
Same as above
ETX
(03H)
Total 155
Parameter
No. of characters
Format
STX
(02H)
Fixed character: D
Text No.: 2
100
100
ETX
(03H)
Total 204
15-20
No. of characters
Format
STX
(02H)
Fixed character: D
Text No.: 3
80
WBC LD
WBC T1
Parameter
Technical Information
Parameter
No. of characters
Format
WBC T2
WBC UD
RBC LD
Same as above
RBC UD
Same as above
PLT LD
Same as above
PLT UD
Same as above
RESERVED
128
ETX
(03H)
Total 228
ch[49]=67(0x43)
The above data is arranged as shown below.
7B2D38...........................43
Instrument ID
Instrument ID is composed of [(Instrument name)^(PS code)]. It is a character string of 40 characters,
left-justified, with space padding. The PS code is fixed according to the instrument specifications.
Example:
Instrument name: pocH-100iV Diff
PS code: 1234
Revised March 2006
pocH-100iV Diff^1234^123456
15-21
Technical Information
KX-21N format
KX-21N format includes an Analysis data format for output of sample data, and a QC data format for
output of QC data. Each has different text length and contents. (They are identified by the sample
distinction code.)
Text distinction code II is usually 1.
However, if the text length becomes 256 bytes or more, the text will be divided into 2 or more blocks for
transmission. The sequence of these blocks will be expressed by the text distinction code II numerals.
([ETB] codes will not be used.)
Analysis data format
15-22
No. of characters
Format
STX
(02H)
Fixed character: D
Text No.: 1
Fixed character: U
Year
Month
Day
Analysis information
Sample ID
15
AB-12345
Particle distribution
analysis information
Species
A - Q
Example: Dog:A, Cat:B, OTHER10:J
WBC
RBC
Same as above
HGB
Same as above
HCT
Same as above
MCV
Same as above
MCH
Same as above
MCHC
Same as above
PLT
Same as above
LYM% (W-SCR)
Same as above
OTHR% (W-MCR)
Same as above
EO% (W-LCR)
Same as above
Parameter
Technical Information
Parameter
No. of characters
Format
LYM# (W-SCC)
Same as above
OTHR# (W-MCC)
Same as above
EO# (W-LCC)
Same as above
RDW-SD
Same as above
RDW-CV
Same as above
PDW
Same as above
MPV
Same as above
P-LCR
Same as above
ETX
(03H)
Total 131
QC data format
Parameter
No. of characters
Format
STX
(02H)
Fixed character: D
Text No.: 1
Fixed character: C
QC method
X control: X, L-J control: L
Year
Month
Day
Hour
Minute
Data ID
RESERVED
RESERVED
WBC
LYM%
Same as above
OTHR%
Same as above
EO%
Same as above
LYM#
Same as above
OTHR#
Same as above
EO#
Same as above
RBC
Same as above
15-23
Technical Information
Parameter
No. of characters
Format
HGB
Same as above
HCT
Same as above
MCV
Same as above
MCH
Same as above
MCHC
Same as above
RDW-SD
Same as above
RDW-CV
Same as above
PLT
Same as above
PDW
Same as above
MPV
Same as above
P-LCR
Same as above
W-SMV
Same as above
W-LMV
Same as above
ETX
(03H)
Total 105
12345
The year-month-day sequence for the date is fixed, regardless of the date format set for the system
settings.
15-24
Technical Information
Analysis information
The format of the analysis information is fixed at zero (0), and cannot be changed.
Particle distribution analysis information
The particle distribution analysis information is composed of the following 5 elements.
1)
Parameter
No. of characters
Histogram information
Histogram information contains the following information.
2)
Code
Explanation
Normal histogram
Abnormal histogram
Manually discriminated
Histogram flag
The histogram flags are composed of the following 10 types. Each type corresponds to a
flagging character for the LCD screen and printer.
The histogram flag is 0 for a normal histogram and is 1 - 2 for a histogram error.
Histogram flag
Remarks
WBC
RBC
PLT
Normal
Normal
Normal
WL
RL
PL
High frequency at
L discriminator (WBC/RBC/PLT)
WU
RL
PU
High frequency at
H discriminator (WBC/RBC/PLT)
DW
DW
MP
MP
T1
Normal (WBC/RBC/PLT)
T1 discriminator cannot be
determined. (WBC)
15-25
Technical Information
Histogram flag
RBC
Remarks
PLT
T2
T2 discriminator cannot be
determined. (WBC)
F1, F2
F2, F3
Species
pocH outputs the analysis results with following species information.
Code Mode / Species
"0"
Background
"A"
(1) Dog
"B"
(2) Cat
"C"
(3) Cattle
"D"
(4) Horse
"E"
(5) OTHER1
"F"
(6) OTHER2
"G"
(7) OTHER3
"H"
(8) OTHER4
"I"
(9) OTHER5
"J"
(10) OTHER6
"K"
(11) OTHER7
"L"
(12) OTHER8
"N"
(14) OTHER10
"O"
(15) OTHER11
"P"
(16) OTHER12
"Q"
(17) OTHER13
Caution!
The analysis data of the code"E" - "Q" is for research.
15-26
Technical Information
Numerical data
Numerical data is composed of the following.
The data is 4 significant digits, with the decimal point excluded. It is output without zero-suppression.
Upper digit
Data
Lower digit
Flag
Flag details
Code
Explanation
Normal
Low reliability
Data masking
In the case of an analysis error, or analysis parameters with no data , the data is changed to the
following.
*0000
In the Cat mode, the data of PDW, MPV and P-LCR are output as 5 spaces (20H).
In the Cattle or Horse mode, the data of EO% and EO# are output as 5 spaces (20H).
Data ID
Data ID for the QC format is the QC file number. It is output as a single character, from 1 to 3.
15-27
Technical Information
K-1000 format
K-1000 format includes an Analysis data format for output of sample data, and a QC data format for
output of QC data. Each has different text length and contents. (They are identified by the sample
distinction code.)
The format for text distinction code II is normally 1.
If the text length exceeds 256 bytes when a modification is made in the future, it will be divided into two
or more blocks for transmission, and the sequence of blocks will be identified by the numerals of the text
distinction code II. (ETB code is not used.)
15-28
No. of characters
Format
STX
(02H)
Fixed character: D
Text No.: 1
Fixed character: U
Year
Month
Day
Analysis information
Sample ID
12
AB-12345
S or C
RDW-CV: C, RDW-SD: S
WBC
RBC
Same as above
HGB
Same as above
HCT
Same as above
MCV
Same as above
MCH
Same as above
MCHC
Same as above
PLT
Same as above
Parameter
Technical Information
Parameter
No. of characters
Format
LYM% (W-SCR)
Same as above
OTHR% (W-MCR)
Same as above
EO% (W-LCR)
Same as above
LYM# (W-SCC)
Same as above
OTHR# (W-MCC)
Same as above
EO# (W-LCC)
Same as above
RDW-SD or RDW-CV
Same as above
PDW
Same as above
MPV
Same as above
P-LCR
Same as above
ETX
(03H)
Total 121
QC data format
Parameter
No. of characters
Format
STX
(02H)
Fixed character: D
Text No.: 1
Fixed character: C
X or L
Year
Month
Day
Hour
Minute
Data ID
RESERVED
S or C
RDW-CV: C, RDW-SD: S
WBC
LYM%
Same as above
OTHR%
Same as above
EO%
Same as above
LYM#
Same as above
OTHR#
Same as above
EO#
Same as above
15-29
Technical Information
Parameter
No. of characters
Format
RBC
Same as above
HGB
Same as above
HCT
Same as above
MCV
Same as above
MCH
Same as above
MCHC
Same as above
RDW-SD or RDW-CV
Same as above
Select the output parameter (RDW-SD/RDW-CV)
in the RDW setting of Host output settings.
PLT
Same as above
PDW
Same as above
MPV
Same as above
P-LCR
Same as above
W-SMV
Same as above
W-LMV
Same as above
ETX
(03H)
Total 99
15-30
Technical Information
Sample ID No.
Although the sample ID No. is a numeral with 15 digits, this format outputs 12 digits, deleting the upper
3 digits. - (2DH) may be inserted in the numeral field depending on usage. In this case, - is
included in the 12 digits.
Particle distribution analysis information
The particle distribution analysis information is composed of the following 5 elements.
1)
Parameter
No. of characters
Histogram information
Histogram information contains the following information.
2)
Code
Explanation
Normal histogram
Abnormal histogram
Manually discriminated
Histogram flag
The histogram flags are composed of the following 10 types. Each type corresponds to a
flagging character for the LCD screen and printer.
The histogram flag is 0 for a normal histogram and is 1 - 2 for a histogram error.
Histogram flag
Remarks
WBC
RBC
PLT
Normal
Normal
Normal
WL
RL
PL
High frequency at
L discriminator (WBC/RBC/PLT)
WU
RL
PU
High frequency at
H discriminator (WBC/RBC/PLT)
DW
DW
Normal (WBC/RBC/PLT)
15-31
Technical Information
Histogram flag
RBC
PLT
MP
MP
Remarks
T1
T1 discriminator cannot be
determined. (WBC)
T2
T2 discriminator cannot be
determined. (WBC)
F1, F2
F2, F3
Numerical data
Numerical data is composed of the following.
The data is 4 significant digits, with the decimal point excluded. It is output without zero-suppression.
Upper digit
Flag
Data
Lower digit
15-32
Technical Information
Flag details
Code
Explanation
Normal
Low reliability
Data masking
In the case of an analysis error, or analysis parameters with no data, the data is changed to the
following.
*0000
In the Cat mode, the data of PDW, MPV and P-LCR are output as 5 spaces (20H).
In the Cattle or Horse mode, the data of EO% and EO# are output as 5 spaces (20H).
ASTM format
For details on ASTM format, see Section 15.7 ASTM communication specifications.
pocH-100iV Diff supports the following two modes to output data in the ASTM format.
(1) ASTM E1381-02 conforming mode
pocH supports ASTM E1381-02 conforming modes for both serial (RS-232C) and LAN (Ethernet)
connections.
The presentation layer conforms to ASTM E1394-97 and the other layers conform to ASTM E138102.
ASTM E1381-02
Standard Specification for Low-Level Protocol to Transfer Messages Between
Clinical Laboratory Instruments and Computer Systems
15-33
Technical Information
ASTM E1394-97
Standard Specification for Transferring Information Between Clinical
Instruments and Computer Systems
Communication specifications
The communication specifications are based on a layer protocol.
1. Physical layer
Specifies the sending and receiving of signals between the instrument and host computer through
physical and electrical connections.
See the subsequent section, Physical layer (hardware).
2. Data link layer
Specifies the sending and receiving of data by link connections and for each frame between the
instrument and host computer.
See the subsequent section, Data link layer (transmission protocol)
3. Presentation layer
Specifies the messages that are sent and received by the instrument and host computer.
See the subsequent section, Presentation layer (pocH-100iV Diff communication).
Serial connection mode LAN connection mode
Presentation Layer
ASTM E1394-97
ASTM E1381-02
TCP/IP
RS-232C
Ethernet
ASTM E1394-97
TCP/IP
Ethernet
Presentation Layer
Data Link Layer and Physical Layer
15-34
Technical Information
(1) Connector
A 25-pin D-SUB male connector is standard for ASTM, however pocH-100iV Diff uses a 9-pin DSUB male connector for input/output on the right side of the main unit.
Pin No.
Signal name
Signal direction
NC
Receive Data
RxD
Transmit Data
TxD
DTR
Signal Ground
SG
DSR
Request To Send
RTS
Clear To Send
CTS
NC
The control signal is not used with ASTM. In addition, do not connect any unused pins.
(2) Signal identification level
Level
Data signal
Control signal
+3 V or more
ON
-3 V or less
OFF
DB-9
DB-9
DB-25
TxD
RxD
RxD
SG
SG
RTS
RTS
CTS
CTS
DTR
20
DTR
DSR
DSR
NC
NC
1
9
TxD
15-35
Technical Information
(4) Interface conditions
Setting
Setting types
Baud rate
Data length
7 bits / 8 bits
Stop bit
1 bit / 2 bits
Parity
15-36
Technical Information
Data link layer (transmission protocol)
The data layer uses a character-oriented protocol for transfer of messages between systems, according to
the standards of 6. Data Link Layer of ASTM E1381-95.
Following is an outline of the communication control procedure. For details, see ASTM E1381-95.
1. Communications status
The data link layer is composed for the following two communications statuses.
Neutral status
Linked status
Establishment phase
Establishes a communications line, and determines the direction of data transfer. In this way,
the sender and receiver are identified, and the change is made from neutral status to linked
status.
2)
Transfer phase
The sender transmits messages to the receiver, until all messages have been transferred.
3)
Termination phase
Releases the communications line. Changes both the sender and receiver from linked status to
neutral status.
Establishment phase
Neutral status
Linked status
Transfer phase
Termination phase
2. Establishment phase
1)
Sender sends [ENQ] to receiver. The receiver sends one of the following responses.
Returns [ACK] if communication is possible.
Returns [NAK] if communication is not possible.
If the response from the receiver is [NAK], the sender waits 10 seconds before sending [ENQ]
again.
Max. 15 sec
Max. 15 sec
Sender
Receiver
Sender
E
N
Q
A
C
K
Receiver
E
N
Q
10 sec
or more
E
N
Q
N
A
K
15-37
Technical Information
2)
If both sides send [ENQ], the host computer must yield authority to the analyzer.
Analyzer sends [ENQ] again after 1 second.
The host computer must wait 20 seconds before sending [ENQ] again.
Max. 1 sec
Analyzer
E
N
Q
Host computer
E
N
Q
E
N
Q
E
N
Q
Analyzer
Host
computer
E
N
Q
20 sec or more
E
N
Q
3. Transfer phase
During the transfer phase, the sender sends messages to the receiver. The transfer phase continues
until all messages have been sent.
1)
Messages are transferred in multiple frames. Each frame contains a maximum of 247
characters (including frame overhead). If the message is longer than 240 characters, it is
divided into 2 or more frames.
2)
3)
If the message is 240 characters or less, it is transferred using a text frame with the following
structure.
[STX][F#][Text][ETX][CHK1][CHK2][CR][LF]
If the text is longer than 240 characters, it is divided into 2 or more frames. The intermediate
frame text termination code is [ETB], and the final frame text termination code is [ETX], as
shown below.
[STX][F#][Text][ETB][CHK1][CHK2][CR][LF]
[STX][F#][Text][ETB][CHK1][CHK2][CR][LF]
[STX][F#][Text][ETX][CHK1][CHK2][CR][LF]
15-38
Explanation
[STX]
Start of frame
[F#]
Frame number.
One of the numbers 0 - 7 is used, starting with 1 and repeating 2, 3, 4, 5, 6, 7,
0. In case of retransmission, the same frame number is sent.
[Text]
ASTM E1394-97 records are used. (See the subsequent section, Presentation
layer (pocH-100iV communication).)
For this reason, the codes below are not used.
0x00-0x06, 0x08, 0x0A, 0x0E-0x1F, 0x7F, 0xFF
[ETB]
[ETX]
Code
Technical Information
Code
Explanation
[CHK1][CHK2]
[CR][LF]
4)
After the sender sends the frame, sender waits until there is a response from the receiver.
Sender does not send the next frame if a response is not received.
5)
If the receiver has successfully received the frame, and is prepared to receive the next frame,
receiver responds with [ACK]. After the sender receives [ACK], sender advances a frame
number increment and sends either a new frame or the termination frame.
6)
If the receiver fails to receive the frame and is prepared to receive the same frame again,
receiver responds with [NAK]. After the sender receives [NAK], sender sends the most recent
frame again, using the same frame number. If a total of 6 attempts to send the frame fail, sender
transitions to the termination phase and must end sending of the message.
Max. 15 sec
Max. 15 sec
Sixth attempt
First attempt
Sender
...
Text frame #1
N
A
K
Receiver
E
O
T
Text frame #1
N
A
K
...
7)
The analyzer processes the response of [EOT] from the host computer as [ACK].
8)
During the transfer phase, a 15-second timer is set when the final character of the frame is sent
by the sender. Time out results if there is no response within 15 seconds. When the sender
times out, sender transitions to the termination phase. A 30-second timer is set when the
receiver first enters transfer status, and when receiver sends a response ([ACK], [NAK]) for
each frame. Time out results if there is no frame transmission or [EOT] response from the
sender within 30 seconds. When the receiver detects time out, receiver discards the incomplete
message that was being received, and transitions to the termination phase.
Max. 15 sec
Max. 30 sec
Max. 15 sec
Sixth attempt
First attempt
E
O
T
Sender
Text frame #1
Receiver
...
Text frame #2
A
C
K
E
O
T
...
15-39
Technical Information
4. Termination phase
During the termination phase, the status returns to neutral.
The sender sends [EOT] to inform the receiver that the message transmission has been completed.
When the sender sends [EOT], sender transitions to neutral status. When the receiver receives [EOT],
receiver transitions to neutral status.
5. Time out
The timer is used to detect a failure to coordinate between the sender and receiver. The timer is used
as a mean of recovery for communications line and communication destination device failures.
1)
During the establishment phase, the timer is set when the sender sends [ENQ]. Time out results
if a response of [ACK], [NAK], or [ENQ] is not received within 15 seconds. After time out, the
sender transitions to the termination phase.
2)
During the transfer phase, the timer is set when the final character of a frame is sent by the
sender. Time out results if no response is received within 15 seconds. After time out, the sender
transitions to the termination phase, and ends message transmission.
T1
T2
E
N
Q
T1
T2
T2
T1
T2
Order (O)
Patient (P)
Header (H)
A
C
K
T1
A
C
K
A
C
K
A
C
K
Host computer
T1
T2
T1
T2
A
C
K
A
C
K
information
record*1
record*1
T2
T1
T2
E
O
T
Terminate (L)
A
C
K
A
C
K
frame
T1
Result n (R)
A
C
K
Patient*2
T2
Result 2 (R)
Result 1 (R)
T1
frame
Note: This figure is shown so that the data link layer conforms to the ASTM E1381-02 specifications.
In case of ASTM E1381 non-conforming mode, no treatment is performed when the ENQ, ACK and
EOT codes are received.
15-40
T2
Technical Information
Messages, records, and fields
1. Messages
In the presentation layer, all data is transmitted using messages. Messages are composed of record
arrays that start with message header record (H) and end with message termination record (L).
2. Records
A record is a series of text, beginning with an ASCII alphabet character referred to as the identifier,
and ending with [CR].
Record type
Record identifier
Level
Contents
Header
Patient information
Inquiry
Not used
Analysis order
Analysis results
Comments
1-4
Not used
Manufacturer information
1-4
Not used
Scientific information
N/A
Not used
Message-end code
All levels other than 0 must be located after higher levels. However, manufacturer information
(not used) and comment records can be inserted at any level. They are considered to be one level
lower than the preceding record.
3. Fields
Records are further divided by field delimiter into multiple fields.
A field is identified by its position within a record, and has a variable length.
The followings are used as delimiter.
Delimiter type
Code
Contents
Repetition delimiter
Used to repeat the same field when the same type of component
exists multiple times in 1 field.
Component delimiter
Escape delimiter
&
Field delimiter
15-41
Technical Information
Record 1
Record 2
Field 1
Field 2
Record n
Field n
[CR]
Delimiter | or \
Record identifier
Component 1
Component 2
Component n
Delimiter ^
Record details
1. Header record
Example of transmission:
pocH100iV Diff Host computer
H|\^&|||pocH-100iV Diff^00-00^^^^Sysmex pocHVD 01^12345678||||||||E1394-97[CR]
Host computer pocH-100iV Diff
H|\^&|||||||||||E1394-97[CR]
15-42
Field name
Analyzer
Host computer
Host computer
Analyzer
7.1.1
Record type
7.1.2
Delimiter definition
|\^&
|\^&
7.1.3
Message control ID
Not used
Not used
7.1.4
Access password
Not used
Not used
7.1.5
Sender name or ID
Instrument name^
Software version^^^^
User instrument No.
^PS code
Not used
7.1.6
Sender address
Not used
Not used
7.1.7
Reserved
Not used
Not used
7.1.8
Not used
Not used
7.1.9
Sender characteristics
Not used
Not used
7.1.10
Receiver ID
Not used
Not used
7.1.11
Comment
Not used
Not used
7.1.12
Process ID
Not used
Not used
7.1.13
Version No.
E1394-97
E1394-97
7.1.14
Not used
Not used
Remarks
pocH-100iV Diff^0000^^^^Sysmex
pocHVD 01
^12345678
Fixed
ASTM
field
Technical Information
Detailed explanation of fields:
1)
2)
2. Patient records
Example of transmission:
pocH-100iV Diff Host computer
P|1[CR]
Host computer pocH-100iV Diff
Not used.
ASTM
field
Field name
Analyzer
Host computer
Host computer
Analyzer
Sequence No.
Not used
8.1.1
Record type
8.1.2
Sequence No.
8.1.3
Patient ID assigned
by attending
physician
Not used
Not used
8.1.4
Patient ID assigned
by laboratory
Not used
Not used
8.1.5
Patient ID
Not used
Not used
8.1.6
Patient name
Not used
Not used
8.1.7
Mothers maiden
name
Not used
Not used
8.1.8
Date of birth
Not used
Not used
8.1.9
Patient sex
Not used
Not used
8.1.10
Patient race
Not used
Not used
8.1.11
Patient address
Not used
Not used
Remarks
Sequence No.
indicating the order
in which this type of
record appears in the
message. This
number begins with
1, and is reset to 1
each time a record at
a higher level appears
in the message.
15-43
Technical Information
15-44
Field name
Analyzer
Host computer
Host computer
Analyzer
8.1.12
Reserved field
Not used
Not used
8.1.13
Not used
Not used
8.1.14
ID of attending
physician
Not used
Not used
8.1.15
Special field 1
Not used
Not used
8.1.16
Special field 2
Not used
Not used
8.1.17
Patient height
Not used
Not used
8.1.18
Patient weight
Not used
Not used
8.1.19
Presumed diagnosis
of patient
Not used
Not used
8.1.20
Not used
Not used
8.1.21
Not used
Not used
8.1.22
Attending physician
field 1
Not used
Not used
8.1.23
Attending physician
field 2
Not used
Not used
8.1.24
Not used
Not used
8.1.25
Condition when
admitted
Not used
Not used
8.1.26
Location
Not used
Not used
8.1.27
Alternative
diagnosis code and
type of classifier
Not used
Not used
8.1.28
Alternative
diagnosis code and
classification
Not used
Not used
8.1.29
Patient religion
Not used
Not used
8.1.30
Marital status
Not used
Not used
8.1.31
Isolation status
Not used
Not used
8.1.32
Language
Not used
Not used
8.1.33
Hospital service
Not used
Not used
8.1.34
Hospital Institution
Not used
Not used
8.1.35
Dosage category
Not used
Not used
Remarks
ASTM
field
Technical Information
Detailed explanation of fields:
1)
3. Order record
Example of transmission:
pocH-100iV Diff Host computer
O|1||^^1234567890ABCDE^A|^^^^WBC\^^^^RBC\^^^^HGB\^^^^HCT\^^^^MCV
\^^^^MCH\^^^^MCHC\^^^^PLT\^^^^LYM%\^^^^OTHR%\^^^^EO%\^^^^
LYM#\^^^^OTHR#\^^^^EO#\^^^^RDW-SD\^^^^RDW-CV\^^^^PDW
\^^^^MPV\^^^^P-LCR|||||||N|||||||(1)Dog|||||||F[CR]
Host computer pocH-100iV Diff
Not used.
ASTM
field
9.4.1
9.4.2
9.4.3
9.4.4
Field name
Record type
Sequence No.
Specimen ID
Instrument
specimen ID
Analyzer
Host computer
O
Sequence No.
Host computer
Analyzer
Not used
Not used
Not used
^^Sample ID^
Sample ID
attributes
Not used
Not used
Remarks
Sequence No.
indicating the order in
which this type of
record appears in the
message. This number
begins with 1, and is
reset to 1 each time a
record at a higher level
appears in the
message.
A sample ID less than
15 digits is extended to
15 digits by space
padding or zero
padding in accordance
with the settings of ID
Pad. made by
Settings - Host
output.
Sample ID attributes
are as follows:
M: Manually input
A: Automatically
allocated
B: Read by ID reader
15-45
Technical Information
ASTM
field
9.4.5
Field name
Analysis parameter
ID
Analyzer
Host computer
^^^^Parameter
name
Host computer
Analyzer
Not used
Remarks
Parameter names:
WBC, RBC, HGB,
HCT, MCV, MCH,
MCHC, PLT,
LYM%, OTHR%,
EO%,
LYM#, OTHR#, EO#,
RDW-SD,RDW-CV,
PDW,MPV,P-LCR
W-SMV,W-LMV
Repetition delimiter is
used to output multiple
parameters.
Example:
^^^^
Parameter name1\
^^^^
Parameter name2\
^^^^
Parameter name3
* LYM%, OTHR%,
EO%, LYM#,
OTHR# and EO# are
output as W-SCR,
W-MCR, W-LCR,
W-SCC, W-MCC
and W-LCC
respectively, When
the analysis was
performed in the
OTHER1 OTHER13 mode.
9.4.6
9.4.7
9.4.8
9.4.9
9.4.10
15-46
Priority sequence
Date and time of
order
Date and time of
collection
Time specimen
collection end
Collection volume
Not used
Not used
Not used
Not used
Not used
Not used
Not used
Not used
Not used
Not used
Sysmex pocH-100iV Diff Instructions for Use
*W-SMV and
WLMV in the
analysis data are not
output.
*PDW, MPV and PLCR in the Cat
mode are not output.
*EO% and EO# in
the Cattle or
Horse mode are not
output.
Technical Information
ASTM
field
9.4.11
9.4.12
Analyzer
Host computer
Not used
N, Q
Host computer
Analyzer
Not used
Not used
Danger code
Related clinical
information
Date/time specimen
was received
Specimen
descriptor
Ordering physician
Physicians
telephone No.
User field 1
Not used
Not used
Not used
Not used
Not used
Not used
Not used
Not used
Not used
Not used
Not used
Not used
Species
Not used
User field 2
Laboratory field 1
Laboratory field 2
Date/time results
were reported or
last modified
Fee for instrument
use
Analyzer ID
Report type
Reserved
Location or ward of
specimen collected
Hospital infection
flag
Specimen service
Specimen
institution
Not used
Not used
Not used
Not used
Not used
Not used
Not used
Not used
Not used
Not used
Not used
F
Not used
Not used
Not used
Not used
Not used
Not used
Not used
Not used
Not used
Not used
Not used
Not used
Field name
Collector ID
Action code
Remarks
N: Normal sample
code
Q: QC data
9.4.13
9.4.14
9.4.15
9.4.16
9.4.17
9.4.18
9.4.19
9.4.20
9.4.21
9.4.22
9.4.23
9.4.24
9.4.25
9.4.26
9.4.27
9.4.28
9.4.29
9.4.30
9.4.31
example: (1)Dog,
(5)OTHERRESEARCH-
F: fixed
4. Result record
Example of transmission:
pocH-100iV Diff Host computer
R|1|^^^^WBC^1|7.8|10*3/L||N||||||20011221163530 [CR]
R|2|^^^^RBC^1|3.50|10*6/L||L||||||20011221163530 [CR]
R|3|^^^^HGB^1|***.*|g/dL||A||||||20011221163530 [CR]
...
R|19|^^^^P-LCR^1|50.0|%||H||||||20011221163530 [CR]
Host computer pocH-100iV Diff
Not used.
15-47
Technical Information
Caution!
The analysis data of the OTHER1 - OTHER13 mode is for research.
ASTM
field
Note:
PDW, MPV and P-LCR in the Cat mode are not output.
10.1.1
Record type
10.1.2
Sequence No.
10.1.3
Analysis parameter
ID
Analyzer
Host computer
Host computer
Analyzer
Not used
Sequence No.
Not used
Sequence No.
indicating the order
in which this type of
record appears in the
message. This
number begins with
1, and is reset to 1
each time a record at
a higher level appears
in the message.
^^^^Parameter
name^Dilution ratio
Not used
Parameter name:
See the analysis
parameter ID (ASTM
field) of analysis
order record.
Remarks
10.1.4
Data value
Data value
Not used
Data values:
These are output after
a decimal point is
added in the correct
position, according to
the units which are
set.
For data which is
masked for display,
the mask codes are
output in order of
priority, in the same
way as they appear
on the screen.
Example: +++.+
15-48
Dilution ratio:
1, WB mode
(fixed)
Technical Information
ASTM
field
10.1.5
Field name
Units
Analyzer
Host computer
Host computer
Analyzer
Remarks
Units
Not used
[Units]
These are output in
the format
determined by the
units setting.
Exponents are
expressed using *.
Example:
103/L 10*3/L
10.1.6
Reference ranges
10.1.7
Not used
Not used
L, H, >, N, A, W
Not used
A:
Data masked for
display
>:
Data with flag !
W:
Data with flag *
H:
Data with flag +
L:
Data with flag -
N:
Any (normal) data
other than the above
The order of priority
is, from highest to
lowest: A, >,
W, H, L, N.
Type of error
analysis
Not used
Not used
10.1.9
Not used
Not used
10.1.10
Date of change to
reference value/units
Not used
Not used
10.1.11
Operator ID
Not used
Not used
10.1.12
Not used
Not used
10.1.8
15-49
Technical Information
ASTM
field
10.1.13
Field name
Date and time
analysis completed.
Analyzer
Host computer
Host computer
Analyzer
Remarks
YYYYMMDD
hhmmss
Not used
The year-month-dayhour-time-second
sequence for the date
is fixed, regardless of
the date format set
for the system
settings.
YYYY:
Year (4 digits*1)
MM:
Month (2 digits*1)
DD:
Day (2 digits*1)
hh:
Hour (2 digits*1)
mm:
Time (2 digits*1)
ss:
Second (2 digits*1)
*1: With zero
padding.
10.1.14
Analyzer ID
Not used
Not used
Analyzer
Host computer
Host computer
Analyzer
ASTM
field
Field name
Remarks
Record type
13.1.2
Sequence No.
Always 1
13.1.3
End code
N: Normal
termination
13.1.1
15-50
Technical Information
Item
Decimal
point
Unit
WBC
####
102 /L
RBC
####
104 /L
Unit
103 /L
106 /L
109 /L
1012 /L
HGB
###.#
g/dL
###.#
g/dL
HCT
###.#
###.#
MCV
###.#
fL
###.#
fL
###.#
fL
MCH
###.#
pg
###.#
pg
###.#
pg
MCHC
###.#
g/dL
###.#
g /dL
####
g /L
PLT
###.#
104 /L
####
103 /L
####
109 /L
LYM%
###.#
###.#
#.###
OTHR%
###.#
###.#
#.###
EO%
###.#
###.#
#.###
LYM#
####
102 /L
###.#
103 /L
###.#
109 /L
OTHR#
####
102 /L
###.#
103 /L
###.#
109 /L
EO#
####
102 /L
###.#
103 /L
###.#
109 /L
W-SCR
###.#
###.#
#.###
W-MCR
###.#
###.#
#.###
W-LCR
###.#
###.#
#.###
W-SCC
####
102 /L
###.#
103 /L
###.#
109 /L
W-MCC
####
102 /L
###.#
103 /L
###.#
109 /L
W-LCC
####
102 /L
###.#
103 /L
###.#
109 /L
RDW-SD
###.#
fL
###.#
fL
###.#
fL
RDW-CV
###.#
###.#
MPV
###.#
fL
###.#
fL
###.#
fL
PDW
###.#
fL
###.#
fL
###.#
fL
P-LCR
###.#
###.#
####
Unit
#.###
g/L
L/L
#.###
#.###
15-51
Technical Information
Item
WBC
RBC
HGB
HCT
MCV
Decimal
point
###.#
##.##
###.#
#.###
###.#
Unit
109 /L
1012 /L
mmol /L
L/L
Unit
109 /L
1012 /L
g/L
#.###
Unit
109 /L
1012 /L
g/dL
#.###
fL
###.#
fL
###.#
fL
MCH
####
amol
###.#
pg
###.#
pg
MCHC
###.#
mmol /L
####
g/L
###.#
g/dL
PLT
####
109 /L
####
109 /L
####
109 /L
LYM%
#.###
#.###
###.#
OTHR%
#.###
#.###
###.#
EO%
#.###
#.###
###.#
LYM#
###.#
109 /L
###.#
109 /L
###.#
109 /L
OTHR#
###.#
109 /L
###.#
109 /L
###.#
109 /L
EO#
###.#
109 /L
###.#
109 /L
###.#
109 /L
W-SCR
#.###
#.###
###.#
W-MCR
#.###
#.###
###.#
W-LCR
#.###
#.###
###.#
W-SCC
###.#
109 /L
###.#
109 /L
###.#
109 /L
W-MCC
###.#
109 /L
###.#
109 /L
###.#
109 /L
W-LCC
###.#
109 /L
###.#
109 /L
###.#
109 /L
RDW-SD
###.#
fL
###.#
fL
###.#
fL
###.#
RDW-CV
#.###
#.###
MPV
###.#
fL
###.#
fL
###.#
fL
PDW
###.#
fL
###.#
fL
###.#
fL
###.#
P-LCR
15-52
#.###
#.###
Technical Information
2. Press the button (once) at the top of the card slot on the right side of
the instrument.
The button will pop out.
4. Check that the button is button is "in", then remove the card.
15-53
Technical Information
Separating the adapter
1. When the program card is removed from the card slot, it is attached
to an adapter.
adapter
Menu
Main
ID
1
Set a mixed
sample, and
Press [RUN].
Species (1)Dog
RUN
select
Result
Not Ready
Menu
Top
Str.Data
Chg.Reag
Calib.
Settings
15-54
Shutdown
Maint.
Revised August 2006
QC
Technical Information
Not Ready
Top
Maint.
Auto Rinse
Status Display
Clog Removal
Calibration LCD
Drain TD Chamber
Clean Transducer
Setting Seq.
Clean W. Chamber
Drain Reagent
Ready
The status display screen will appear. Check the version of the
program.
Top
Maint.
Vacuum
HGB Convert
Sensor
SV
0. 0130 MPa
2012 (255)
1 2 3 4 5 6 7 8
1 2 3 4 5 6 7 8 9 0
1 2 3 4 5 6 7 8 9 0
1 2 3 4 5 6 7 8 9 0
1 2 3 4 5 6 7 8 9 0
123456
123456 (17/05/2000)
123456 (17/05/2000)
00-00 (BIOS: 00-00)
Counter
Waste C.
Detector
Version
Run
DC detection method
DC
DC Supply
Transducer Chamber
External Electrode +
Resistance
15-55
Technical Information
Hydrodynamic focusing DC detection method
Inside the detector, the sample nozzle is positioned in front of the
aperture and in line with the center. After diluted sample is forced from
the sample nozzle into the conical chamber, it is surrounded by front
sheath reagent and passes through the aperture center.
Aperture
Front sheath reagent
Sample nozzle
15-56
Technical Information
Measuring unit hydraulic system block diagram
<Whole Blood Mode>
0.59 mL
WBC/HGB Lyse
0.72 mL
1:130 Diluted Sample (461 L)
WBC/HGB
TD Chamber
(Approx. 1:500)
Diluent
1.9 mL
RBC/PLT
Sample Chamber
(Approx. 1:1360)
1.935 mL
Whole Blood Sample (15 L)
Aspirating Pipette
Mixing Chamber
(Approx. 1:130)
HCT (%)
6
10
HGB (g/dL)
6
10
100
MCHC (g/dL) =
15-57
Technical Information
Electric system
The microprocessor in the main unit controls the hydraulic system's solenoid valves and syringe, thus
regulating the flow of samples, reagents, and waste in the hydraulic system.
Electric signals received from various transducers go through the analogue circuit for electrical
waveform-processing, and to the microcomputer. The microcomputer converts the analogue signals into
digital signals for the calculation.
The WBC, RBC, and PLT cell signals are sent to the respective waveform-processing circuits in the
analogue circuit, where the noise in signals is eliminated to acquire the required cell signals only. The
microcomputer converts the A/D-converted cell signals into particle distribution data, and outputs them
to the built-in printer or to the host computer.
To calculate HGB, absorbance of only the diluent (background) is deducted from samples' absorbance.
The beam that has passed through the fluid is detected by the photo diode. And the signals is
photoelectrically converted, A/D converted, and then sent to the HGB counting circuit for the calculation
of the absorbance.
15-58
HGB
Amplification
Circuit
HGB
Detector
Temperature
Monitoring
Circuit
Pressure
Monitoring
Circuit
WBC,
RBC, PLT
Detection Circuit
Analogue Circuit
WBC,
RBC, PLT
Transducer
Transducer
Main Unit
Power Supply
Circuit
HGB
Conversion
Circuit
WBC, PLT
Amplification
Waveform
Processing
Circuit
RBC
Waveform
Processing
Circuit
Driver
Solenoid
Motor
A-D
Conversion
Circuit
PDA Unit
PDA Unit
RBC A-D
Conversion
Circuit
PLT, WBC A-D
Conversion
Circuit
InputOutput
Interface
Data
Logger
Microcomputer Circuit
Printer
Interface
Interface
LCD
Interface
Serial Interface
Processor
Memory
Built-in
Printer
Operation
Unit
Display Unit
HC Output
Built-in Printer
Touch Panel
LCD Display
(Computer)
Technical Information
Electric diagram
15-59
Bus
Technical Information
15-60
Warranty
16. Warranty
All Sysmex instruments are warranted against defective material or
workmanship for a period of one year, commencing on the installation
date at the customer's premises.
This warranty does not cover any defect, malfunction or damage due to:
Accident, neglect or wilful mistreatment of the product;
July 2005
16-1
July 2005
Warranty
16-2
Glossary
17. Glossary
CBC8-Parameter; Complete Blood Count
WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT
Resistance measuring method
This method for counting blood cells makes use of the fact that the blood
cells to be counted act as insulator in an electrolytic solution. The device
for counting the cells consists of an electric static field, limited by an
aperture. When blood cells pass through the aperture, an electrolyte
volume equivalent to that of the blood cell is displace, causing changes
in resistance, which are detected as measurable variable.
Photometric measuring method
An optical measuring method is used for the determination of
hemoglobin concentration. From the extinction, measured at the
maximum hemoglobin absorption of blood sample diluted and lysed
under standardized conditions, the HGB concentration is determined.
Discriminator
With discriminators or thresholds, the different populations of a multiple
counting result are demarcated against each other (discriminated).
Histogram
The graphical representation of quantified data in a line or column chart,
where the frequency of each measured value is represented by the size
(or height) of a rectangular over the corresponding data class of the
abscissa. In hematology, a histogram is the volume frequency
distribution of blood cells, from which statements on quantity and
quality of the sample can be derived.
Histogram parameter
17-1
Glossary
17-2
Sysmex pocH-100i
Appendix
18. Appendix
Maintenance Record pocH-100iV Diff
Year:
Month:
Daily
Maintenance item
Day
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
Clean TD chambers
and hydraulic system
(Shutdown)
Signature
Maintenance item
Day
Clean TD chambers
and hydraulic system
(Shutdown)
Signature
Maintenance item
Day
Clean TD chambers
and hydraulic system
(Shutdown)
Signature
Every 2 weeks
Maintenance item
Week
Clean transducer
July 2005
Signature
18-1
Appendix
Every 3 months
Year:
Maintenance item
Month:
Expiration
date
Signature
Lot ID
Month/Day
Expiration
date
Signature
July 2005
Lot ID
18-2
Appendix
pocH-pack LVD
Lot ID
Month/Day
Expiration
date
Signature
Lot ID
Month/Day
Expiration
date
Signature
Replace supplies
Maintenance item
Month/Day &
Signature
Month/Day &
Signature
Month/Day &
Signature
Month/Day &
Signature
Replace fuses
July 2005
18-3
Appendix
Optional parts list
Part No.
Part name
Explanation
TOUCH65-PRO
265-9151-5
CAB320-D1N8
281-9577-5
265-4728-3
442-3032-1
COLLECTION TUBE
(12-15 MM DIAMETER)
Color: black
July 2005
281-9576-1
18-4
July 2005
The precise terms and conditions for copying, distribution and modification follow.
19-1
July 2005
In addition, mere aggregation of another work not based on the Program with the Program (or with a work based on
the Program) on a volume of a storage or distribution medium does not bring the other work under the scope of this
License.
19-2
3. You may copy and distribute the Program (or a work based on it, under Section 2) in object code or executable
form under the terms of Sections 1 and 2 above provided that you also do one of the following:
a) Accompany it with the complete corresponding machine-readable source code, which must be distributed
under the terms of Sections 1 and 2 above on a medium customarily used for software interchange; or,
b) Accompany it with a written offer, valid for at least three years, to give any third party, for a charge no more
than your cost of physically performing source distribution, a complete machine-readable copy of the corresponding source code, to be distributed under the terms of Sections 1 and 2 above on a medium customarily
used for software interchange; or,
c) Accompany it with the information you received as to the offer to distribute corresponding source code. (This
alternative is allowed only for noncommercial distribution and only if you received the program in object
code or executable form with such an offer, in accord with Subsection b above.)
The source code for a work means the preferred form of the work for making modifications to it. For an executable
work, complete source code means all the source code for all modules it contains, plus any associated interface definition files, plus the scripts used to control compilation and installation of the executable. However, as a special exception, the source code distributed need not include anything that is normally distributed (in either source or binary
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unless that component itself accompanies the executable.
If distribution of executable or object code is made by offering access to copy from a designated place, then offering
equivalent access to copy the source code from the same place counts as distribution of the source code, even though
third parties are not compelled to copy the source along with the object code.
4. You may not copy, modify, sublicense, or distribute the Program except as expressly provided under this License.
Any attempt otherwise to copy, modify, sublicense or distribute the Program is void, and will automatically terminate your rights under this License.
However, parties who have received copies, or rights, from you under this License will not have their licenses terminated so long as such parties remain in full compliance.
5. You are not required to accept this License, since you have not signed it. However, nothing else grants you permission to modify or distribute the Program or its derivative works. These actions are prohibited by law if you do
not accept this License. Therefore, by modifying or distributing the Program (or any work based on the Program),
you indicate your acceptance of this License to do so, and all its terms and conditions for copying, distributing or
modifying the Program or works based on it.
6. Each time you redistribute the Program (or any work based on the Program), the recipient automatically receives
a license from the original licensor to copy, distribute or modify the Program subject to these terms and conditions.
You may not impose any further restrictions on the recipients' exercise of the rights granted herein. You are not
responsible for enforcing compliance by third parties to this License.
7. If, as a consequence of a court judgment or allegation of patent infringement or for any other reason (not limited to
patent issues), conditions are imposed on you (whether by court order, agreement or otherwise) that contradict the
conditions of this License, they do not excuse you from the conditions of this License. If you cannot distribute so
as to satisfy simultaneously your obligations under this License and any other pertinent obligations, then as a consequence you may not distribute the Program at all. For example, if a patent license would not permit royalty-free
redistribution of the Program by all those who receive copies directly or indirectly through you, then the only way
you could satisfy both it and this License would be to refrain entirely from distribution of the Program.
July 2005
If any portion of this section is held invalid or unenforceable under any particular circumstance, the balance of the
section is intended to apply and the section as a whole is intended to apply in other circumstances.
19-3
It is not the purpose of this section to induce you to infringe any patents or other property right claims or to contest
validity of any such claims; this section has the sole purpose of protecting the integrity of the free software distribution system, which is implemented by public license practices. Many people have made generous contributions to the
wide range of software distributed through that system in reliance on consistent application of that system; it is up to
the author/donor to decide if he or she is willing to distribute software through any other system and a licensee cannot
impose that choice.
This section is intended to make thoroughly clear what is believed to be a consequence of the rest of this License.
8. If the distribution and/or use of the Program is restricted in certain countries either by patents or by copyrighted
interfaces, the original copyright holder who places the Program under this License may add an explicit geographical distribution limitation excluding those countries, so that distribution is permitted only in or among countries not
thus excluded. In such case, this License incorporates the limitation as if written in the body of this License.
9. The Free Software Foundation may publish revised and/or new versions of the General Public License from time
to time. Such new versions will be similar in spirit to the present version, but may differ in detail to address new
problems or concerns.
Each version is given a distinguishing version number. If the Program specifies a version number of this License
which applies to it and "any later version", you have the option of following the terms and conditions either of that
version or of any later version published by the Free Software Foundation. If the Program does not specify a version
number of this License, you may choose any version ever published by the Free Software Foundation.
10. If you wish to incorporate parts of the Program into other free programs whose distribution conditions are different, write to the author to ask for permission. For software which is copyrighted by the Free Software Foundation,
write to the Free Software Foundation; we sometimes make exceptions for this. Our decision will be guided by the
two goals of preserving the free status of all derivatives of our free software and of promoting the sharing and reuse
of software generally.
NO WARRANTY
11. BECAUSE THE PROGRAM IS LICENSED FREE OF CHARGE, THERE IS NO WARRANTY FOR THE
PROGRAM, TO THE EXTENT PERMITTED BY APPLICABLE LAW. EXCEPT WHENOTHERWISE
STATED IN WRITING THE COPYRIGHT HOLDERS AND/OR OTHER PARTIES PROVIDE THE PROGRAM "AS IS" WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESSED OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS
FOR A PARTICULAR PURPOSE. THE ENTIRE RISK AS TO THE QUALITY AND PERFORMANCE OF
THE PROGRAM IS WITH YOU. SHOULD THE PROGRAM PROVE DEFECTIVE, YOU ASSUME THE
COST OF ALL NECESSARY SERVICING, REPAIR OR CORRECTION.
July 2005
12. IN NO EVENT UNLESS REQUIRED BY APPLICABLE LAW OR AGREED TO IN WRITING WILL ANY
COPYRIGHT HOLDER, OR ANY OTHER PARTY WHO MAY MODIFY AND/OR REDISTRIBUTE THE
PROGRAM AS PERMITTED ABOVE, BE LIABLE TO YOU FOR DAMAGES, INCLUDING ANY GENERAL, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF THE USE OR
INABILITY TO USE THE PROGRAM (INCLUDING BUT NOT LIMITED TO LOSS OF DATA OR DATA
BEING RENDERED INACCURATE OR LOSSES SUSTAINED BY YOU OR THIRD PARTIES OR A FAILURE OF THE PROGRAM TO OPERATE WITH ANY OTHER PROGRAMS), EVEN IF SUCH HOLDER OR
OTHER PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
19-4
July 2005
This General Public License does not permit incorporating your program into proprietary programs. If your program is a subroutine library, you may consider it more useful to permit linking proprietary applications with the
library. If this is what you want to do, use the GNU Library General Public License instead of this License.
19-5
July 2005
19-6
Index
20. Index
A
Abbreviations .................................................... 1-4
Abbreviations and unit used throughout this manual .. 1-4
Action message screen ........................................ 6-3
Additional special equipment ....................... 4-1, 4-3
Adjusting the contrast of the LCD screen .............. 5-12
Alphabetical error massage index ........................ 14-4
Ambient temperature .................................. 4-1, 4-2
Analysis ........................................................... 3-5
Analysis data ..................................................... 8-4
Analysis in whole blood (WB) mode ...................... 7-5
Analysis mode ................................................... 8-4
Analysis parameters ............................................ 1-5
Analyzing samples ............................................. 7-9
Appendix ........................................................ 18-1
As-needed maintenance ..................................... 13-1
ASTM communication specifications ................. 15-33
Automatic calibration ........................................ 11-2
Avoidance of biohazards ...................................... 2-2
Avoidance of Infections ....................................... 2-2
D
B
Background check ..................................... 3-5, 7-3
Bar code reader (optional) .................................... 5-7
Bar code reader settings ..................................... 15-8
Bar code safety .................................................. 2-2
Basic instrument settings ..................................... 5-8
Basic operation area ............................................ 6-3
Before installation .............................................. 5-1
20-1
Index
E
F
Fifth analysis screen ........................................... 8-3
Finishing the stored data processing program .......... 8-8
First analysis screen ........................................... 8-1
Flowchart of analysis procedure ........................... 7-1
Format ......................................................... 15-17
Fourth analysis screen ......................................... 8-3
Front view (with the front lower panel removed) ...... 3-1
Functional description ............................ 3-5, 15-56
I
ID ................................................................... 8-4
ID Bar code Specifications ................................ 15-9
Initial operation ................................................. 5-1
Input from handheld bar code reader (option) .......... 7-8
Input via numerical keys dialog ............................ 7-8
Installation ....................................................... 2-2
Installing the program card .............................. 15-54
Instrument setup .............................................. 12-1
Instruments can be used .............................. 4-1, 4-3
Intended purpose ....................................... 4-1, 4-2
Interface protocol ........................................... 15-13
Introduction .............................................. 1-1, 7-1
L
LAN communication ...................................... 15-16
Latest sample .................................................... 8-1
Levey-Jennings control ......................... 10-2, 10-15
List of consumables ....................................... 13-29
List of provided parts for pocH-100iV Diff ............. 5-1
G
M
Main screen/Menu screen .................................... 6-1
Maintenance ..................................................... 2-5
Maintenance Record pocH-100iV Diff ................. 18-1
Maintenance schedule ....................................... 13-1
Manual analysis.................................................. 8-8
Manual analysis flag ........................................... 8-6
Manual calibration ........................................... 11-6
Measuring unit hydraulic system block diagram ... 15-57
Menu tree ......................................................... 6-7
Methodology ............................................ 4-1, 4-2
20-2
Index
N
Names .............................................................. 1-4
Network settings .............................................. 12-8
Non-Cyanide Hemoglobin analysis method ......... 15-56
Numerical keys dialog ......................................... 6-5
O
Operation .......................................................... 6-1
Optional parts list ............................................. 18-4
Ordering of supplies and replacement parts ............. 1-2
Output ........................................... 3-6, 8-12, 9-1
Output format for host computer ....................... 15-13
Output on built-in thermal printer ........................ 15-5
Overview .......................................................... 3-1
Q
QC settings ..................................................... 12-7
Quality Control .................................................. 7-4
Quality control ................................................. 10-1
Quality control process flow ............................... 10-5
R
RBC histogram .................................................. 8-6
Reagents ........................................................... 4-1
Rear side .......................................................... 3-4
Recording QC data ......................................... 10-20
Relocation of discrimination position ..................... 8-9
Removal of fixing tape ........................................ 5-4
Remove a clog from transducer aperture ............. 13-13
Removing the program card ............................. 15-53
Replace reagent .............................................. 13-24
Replace thermal printer paper ........................... 13-28
Re-selection of species ........................................ 8-8
Resistance measuring method ............................. 17-1
Right view (with the right side panel opened) ........... 3-2
20-3
Index
S
W
Warning labels on the instrument .......................... 2-7
Warranty ........................................................ 16-1
WBC histogram ................................................. 8-6
Weekly .......................................................... 18-1
X
X control
20-4