Biolis 30i - ManualAjustes - V1.4

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Analizador Clinico Automatico

TOKYO BOEKI MEDISYS INC.


Manufactured by Tokyo Boeki Medisys Inc.
1-14-21, Higashitoyoda, Hino-shi, Tokyo 191-0052, Japan
Tel: (81)-42-587-7777
Ajustes

Contenido

1. Sumario....................................................................................................................... 3
2. Installation conditions and precautions ........................................................................ 3
3. Specifications of PC and LAN cable .............................................................................. 5
4. Overview of analyzer ..................................................................................................... 6
4.1 Front view .............................................................................................................. 6
4.2 Plan view of analyzing unit .................................................................................... 6
4.3 Side view ................................................................................................................ 7
4.4 Rear view................................................................................................................ 7
5. Work flow for installation .............................................................................................. 8
6. PC setup and software installation ............................................................................... 9
6.1 PC configuration..................................................................................................... 9
6.2 PC configuration Example; In case of Windows 10 .............................................. 9
6.3 Software installation ............................................................................................ 11
7. Unpacking ................................................................................................................... 12
8. Confirmation of accessories in packing ....................................................................... 15
9. Removal of fixing metal parts and packing materials ................................................. 16
10. Preparation for tanks .................................................................................................. 17
10.1 Water supply tank (10 L) ...................................................................................... 17
10.2 Detergent tanks (Alkaline detergent and Acid detergent).................................... 18
10.3 Waste tank (10 L) ................................................................................................. 19
10.4 Separate collection tank (5L)................................................................................ 21
11. Electric wiring and tubing........................................................................................... 22
11.1 Tubing connection................................................................................................. 22
11.2 Connection of Power cable .................................................................................... 25
12. Setup of Electrolyte (ISE) unit .................................................................................... 26
12.1 Preparation of electrode (removal of bubble) ........................................................ 26
12.2 Installation of electrodes ...................................................................................... 27
12.3 Preparation of Roller pump tube .......................................................................... 28
12.4 Installation of Calibrator 1 ................................................................................... 29
13. Start up of the analyzer .............................................................................................. 30
14. Confirmation and version up the FPGA version ......................................................... 32
15. Setting of analyzer temperature correction ................................................................. 34
16. Confirmation of Temperature control function ............................................................ 35
16.1 Confirmation of Temperature control for Reagent tray (RCT) and Wash solution
preheater (WSH)................................................................................................... 35
16.2 Confirmation of Reagent tray (RGT) .................................................................... 36
17. Initialization of analyzer (Ready) ................................................................................ 37
18. Position check and manual operation check................................................................ 38
18.1 Sample probe (STM) position check ..................................................................... 38
18.2 Reagent probe (RTM) position check .................................................................... 41
18.3 Cell washing station (CWS) position check .......................................................... 44
18.4 Mixing unit (MU) position check .......................................................................... 46
18.5 Setting the maximum descent position of the sample probe when measuring sample
with cup on tube ................................................................................................... 48
18.5.1 Determination of the number of pulses ......................................................... 48
18.5.2 Setting the number of pulses......................................................................... 49

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V1.4

18.5.3 Check the maximum descent position .......................................................... 50


19. Prime (filling tubing with water) ................................................................................ 51
20. Air removal of the clot sensor ..................................................................................... 52
1) Preparation of jig. ................................................................................................ 52
2) Air removal procedure ........................................................................................ 53
21. Special wash ............................................................................................................... 56
22. Auto gain (Gain adjustment) ...................................................................................... 59
23. Test run....................................................................................................................... 61
23.1 Water blank measurement................................................................................... 61
23.2 Test Item measurement ....................................................................................... 65
24. ISE Calibration ........................................................................................................... 71
25. ISE correction procedure by the ISE CRS .................................................................. 74
26. Confirmation of the CRS correction ............................................................................ 76
27. Creation of Maintenance list ...................................................................................... 77
27.1 Daily maintenance and exchange work list ......................................................... 78
28. Settings for user operation ......................................................................................... 79
28.1 Implementation setting method........................................................................... 79
28.2 Authorization for analyzer operation settings ..................................................... 80
28.3 Setting of user level and password ...................................................................... 81
29. Shutdown.................................................................................................................... 83

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Setup Manual

1. Sumario

El manual se usa para la instalacion y precauciones del analizador


Nota; La instalcion debe ser realizada por personal capacitado

2. Instalacion condiciones y precauciones

La ubicacion debe cumplir con las siguientes condiciones


1) Libre de Polvo y buena ventilacion
2) Evitar la exposicion directa a la luz solar
3) Nivelado 5mm/m o menor
4) Mesa capaz de soportar 100 Kgr de peso o superior
5) Temperatura ambiente15-30 variacion no mayor a 2 grados .
6) Humedad entre 45 a 80% sin condensacion
7) No debe haber vibraciones
8) Variacion electrica no mayor al 10%
9) Libre de amisiones electromagneticas por equipos cercanos como centrifugas
equipment
otros etc.)etc
equipos,
10) Las tomas electrica deben ser polarizadas con conexion a tierra
clase D con resistencia de 100 ahmios o menor
11) Capacidad electrica de 600 VA o mayor
12) Evitar conecciones multiples de energia
13) No usar conectores electricos inapropiados
Rating) 125V 7A and more for AC 100V/15V, 250V 3.5V and more for AC 220V/230V
14) Insertar firmemente la toma electrica
15) Altitud maxima de instalacion 2000 metros
trabajo no superior a los 2000 metros
16) Referirse a la grafica para los espacios requeridos alrededor del analizador

17) Recipientes de agua destilada y desechos deben colocarse bajo el analizador

Sistemas de purificacion de agua pueden instalarse bajo o al mismo nivel del analizador
del analizador cuando van conectados en forma directa
18) Los recipientes de detergente puede ir bajo o al mismo nivel del analizador

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V1.4

Ejemplo de instalacion

A A: Analizador
B: PC
B
C: Desechos ISE
C D: Suministros de Agua

Vista Superior

A
A: Analizador
B: PC
C: Desechos ISE
B
C
D: Suministros de Agua
E: Recipiente separado
D F: Desechos
G: Agua Destilada
H I: Detergentes
Detergente Alcalino
Detergente Acido

E F G H I

Vista Frontal

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Setup Manual

3. Computador y cable LAN

La configuracion de la PC depende de cada tipo

Refierase a las instrucciones de la PC


Please use a valid PC for IEC 60950.

Computador
Type Integrated type
OS Windows 10 64bit
CPU Intel Core i5/i7
Memory 8 GB
Chip set Not specified
Auxiliary storage 500 GB hard disk
Video chip Not specified
Video ram Not specified
Resolution, WXGA++(1600×900) and more
Display
Available for multi-touch
Loudspeaker Yes
LAN Wired

Specifications for LAN cable (recommendation)


Standard CAT5e (category 5 e) and more

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V1.4

4. Vistas del Analizador

Referirse al Capitulo I 1.3 Retiro de cubiertas

4.1 Vista Frontal

A: Cubierta superior
B: Panel frontal

4.2 Vista Superior de los componentes

A: Bandeja de muestras
F B: Sample probe
H G C: Bandeja de reactivos
D: Reagent probe
E: Bandeja de reacciones
F: Mesclador
E B G: Cell washing station
H: Lamp house
I: Washing trough for probe

C I A
D

Plan view of analyzing unit when the top cover is removed.

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Setup Manual

4.3 Side view

A : Top cover
B-1 : Left side panel
B-2 : Right side panel
C : Front Panel
D : Main switch panel
B-1 A
E : Water supply/drain panel
F : ISE module
(Inside the door)

C
D

Left side

A
B-2

E
F
C

Right side

4.4 Rear view

A : Nameplate
B, C, D: Heat radiating fan

B C

Rear view

7
V1.4

5. Work flow for installation

Basic work flow of analyzer installation is as follows.


"*" items are performed as needed.

1) PC setup
PC configuration
Software installation
2) * Water purification system setup
3) Unpacking
4) Confirmation of accessories in packing
5) Removal of fixing metal parts and packing materials
6) Preparation for tanks
7) Electric wiring and tubing
8) * Electrolyte (ISE) unit setup
9) Starts up of the analyzer
10) Temperature correction parameter settings
11) Confirmation of Temperature control function
Reaction tray, Washing water of preheater, Reagent tray
12) Initialization of the analyzer
13) Position check and manual operation check
14) Priming operation (filling the water supply lines with water)
15) Auto gain (controlling light intensity)
16) Test run
Water blank measurement, test item measurement
17) * Electrolyte (ISE) item calibration
18) * Electrolyte correction (ISE CRS measurement)
19) Creation of Maintenance list
20) Settings
Implementation setting method
Authorization for analyzer operation settings
Settings of login level and password
21) Shutdown

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Setup Manual

6. PC setup and software installation

6.1 PC configuration

The setting method differs depending on the PC to be used.


1) [Screen saver] is set as [None].
2) [Turn off the display] is set as [Never].
3) [Put the computer to sleep] is set as [Never].
4) [Turn off hard disk after] is set as [Never].
5) [IP address] is configured.
6) [Network adapter] is set.
7) Uninstall antivirus software (except for Microsoft Windows standard antivirus
software).
8) Deactivate the time synchronization
Unselect "Synchronize with an internet time server"

6.2 PC configuration Example; In case of Windows 10

Depending on the Windows 10 version, opening of setting screen is different.


1) [Screen saver] setting
[Screen saver] is set as [None].
① Click [Start] button on the PC, and open the [Setting] screen.
② Select [Personalization].
③ Select [Lock screen].
④ Select [Screen saver settings].
⑤ Select [None].
⑥ Click [OK].
⑦ Click [×], and close the unnecessary windows.
2) [Display power] and [PC sleep mode] setting.
[Turn off the display] is set as [Never]
[Put the computer to sleep] is set as [Never]
① Click [Start] button on the PC, and open [Setting] screen.
② Select [System].
③ Select [Power & sleep].
④ Select [Power] setting [Never].
⑤ Select [Sleep]} setting [Never].
⑥ Click [×], and close the unnecessary Windows.
3) [Hard disk power] setting.
[Turn off hard disk after] is set as [Never].
① Right click on the [Start] button of the PC.
② Select [Power Options].
③ Select + on the Hard disk.
④ Set [Never] by inputting [0] for the setting.
⑤ Click [OK].
⑥ Click [×], and close the unnecessary Windows.

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V1.4

4) [Power supply of display] setting.


[Turn off the display power] is set as [None]
[Put the computer to sleep] is set as[None]
① Right click on the [Start] button of the PC.
② Select [Control panel].
③ Select [Hardware and Sound].
④ Select [Power Options].
⑤ Select [Change plan settings] in the displayed screen.
⑥ Select [Turn off the display] and [Put computer to sleep] to [Never].
⑦ Select [Save Changes].
⑧ Click [×], and close the unnecessary Windows.
5) [IP address] setting.
The default setting is explained when the user has no limitation for the IP
address setting.
In case of connection is unable by LIS, multiple installation of BIOLIS
analyzer, please prioritize the user site.
In case of to change from the default setting, refer to Chapter 11 11.1 IP
address change procedure in Service manual.
① Right click the [Start] button on the PC.
② Select [Network connections].
③ Select {Ethernet}.
④ Select [Internet Protocol Version 4 (TCP/IPv4)].
⑤ Select [Properties].
⑥ Input the following numbers in [Use the following IP address].
There may be changes depending on the user.
[IP Address]:[192.168.1.1]
[Subnet mask]:[255.255.255.0]
⑦ Select [OK].
⑧ Click [×], and close the unnecessary Windows.
⑨ Select [System] on the analyzer program.
⑩ Select [Offset].
⑪ Confirm that [PC] of [IP Address] is the same as [IP address] entered in ⑥.
6) [Network adapter] setting.
① Close the analyzer program.
② Right click on the [Start] button of the PC.
③ Select [Control Panel.
④ Select [Network and Internet] - [Network and Sharing Center] - [Change
adapter settings] to open the [Network connections] screen.
⑤ Right-click the adapter to be connected with the analyzer (in case of the above
network connection screen example, [Ethernet]) and open [Properties].
⑥ Select the [Network] tab and select from the list of [This connection uses the
following items]
Uncheck all checks except [Internet Protocol Version 4 (TCP / IPv4)].
⑦ Click [OK].
⑧ Click on × in the upper right of the screen to close the network connection
screen.
⑨ Startup the analyzer program, and confirm that the analyzer can be operated.

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Setup Manual

6.3 Software installation

The database and system are installed as follows.

① Start up the PC.


② Install the [NetFramework3.5]
Procedure (Internet environment is necessary)
-1.Open the [Control Panel]−[Programs]−[Turn Windows features on or off]
-2. Check the [.NET Framework 3.5(includes .NET2.0 and 3.0)] in the
Windows Feature list.
-3. Click [OK].
-4. Close the screen.

③ Insert the disk to the CD drive.


④ Installation begins automatically.
⑤ Perform installation according to the wizard.
⑥ Security dialog of Windows may display on the screen during installation.
Enable them.
⑦ Select a language at installation.
⑧ Click [Install] button.
⑨ Click [Next] and [Agree] for proceeding.
⑩ Input S/N, select a default language and select a name of the analyzer.
⑪ Click [Next]) button.
⑫ Click [Install] button.
⑬ Click [Complete] button when the installation is completed. This is the end of
the installation.
⑭ Take out the disk from the CD drive and shut down the PC.

In case of Version up; Insert version up disk to the CD drive for installation.
Uninstallation of the old version is unnecessary.

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V1.4

7. Unpacking

Unpacking is performed as follows.

1) Confirm the serial number on the analyzer and the contents of the invoice
description.
2) Remove 2 packing bands.

Packing bands

Packing box

3) Open the lid of the outer box and take out the packing material.
4) Take out the accessories.

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Setup Manual

5) Take out the partition plate between the analyzer and the accessories.

6) Pull up the outer box and remove it.

7) Pull up the inner barrel and remove it.

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V1.4

8) Remove the packing materials.


9) Insert your hands under the analyzer from each side. And quietly lift it up and put it
on the desk.
Note;
Do the installation by 4 persons and more.
The table for the installation should have enough durability for the analyzer
weight (around 95Kg).

10) Place the setup PC on the analyzer's side.

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Setup Manual

8. Confirmation of accessories in packing

Confirm accessories and their quantity according to packing list (certification of


contents).
Accessories with check marks in the confirmation fields are packed.

Packing list example (certification of contents)

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V1.4

9. Removal of fixing metal parts and packing materials

Remove 3 fixing parts, fixing tapes and packing materials.

Remove fixing parts that are wrapped around Drive shafts of Sample probe,
Reagent probes and Reaction cell washing station.

Packing materials

Fixing parts

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Setup Manual

10. Preparation for tanks

Prepare Water supply tank, Detergent tanks, Waste tank, and Separate collection
tank.
If the water purification system is connected to the analyzer, please refer to the
operation manual of water purification system.

10.1 Water supply tank (10 L)

Water supply tank: has a [ION-EXCHANGE WATER] seal on the side of the
tank.

1) Loosen the cap of Water supply tank and


remove the float switch and the filter.
2) ① Confirm that the filter is inserted
properly and the filter gets no dirty.
3) ② Confirm that the float switch moves
up/down smoothly.
4) Return the float switch and the filter to
the original position. And tighten the
cap.
5) Firmly insert Junron tube ( 6 blue) for
Water supply tank to the joint of the cap.
Pull the tube and confirm that the tube
cannot be pulled out.

17
V1.4

10.2 Detergent tanks (Alkaline detergent and Acid detergent)

There are two cleaning solution containers. Preparation procedures


are the same.
Alkaline detergent=Dilute to 2% for use.
Acid detergent=Dilute to 1% for use.

1) Remove the cap of Detergent tank.


2) Loosen the cap and take out the float switch and the filter.
3) Confirm that the filter is clean and inserted firmly.
4) Confirm that the float switch moves up/down smoothly.
5) Assemble back the float switch and the filter. Screw the cap tightly.
6) Cut Poalon tube around 1 m. Insert one end into the adapter of filter holding
pipe, firmly.

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Setup Manual

10.3 Waste tank (10 L)

Waste tank: has [WASTE LIQUID] seal on the side.

1) Loosen the cap with a sensor cable and


remove the float switch.
2) Confirm that the float switch smoothly
moves up/down.
3) Return the float switch on the original
position and tighten the cap.

4) Remove the cap of the opposite side and


remove the nozzle part.
The nozzle part is attached on the
cap when discarding liquid waste.
Use it as needed.

5) Insert the vinyl tube ( 10 transparent)


and Junron tube ( 6 transparent) into
the inner/outer caps.
6) Fix the tubes with insulation locks in the
parts box and fasten the cap.

19
V1.4

Note;
Cut the tube until appropriate length if it is too, long.
If the tube for Waste tank is fixed on the waste tank cap, the tube may come off
due to too, short insertion amount. Be careful that too, long insertion amount of
the tube causes a lot of foaming.

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Setup Manual

10.4 Separate collection tank (5L)

Separate collection tank: has (REACTION LIQUID) seal on top of the tank.

1) Loosen the cap with a sensor cable and


remove the float switch.
2) Confirm that the float switch smoothly
moves up/down.
3) Return the float switch on the original
position and tighten the cap.

4) Remove the cap of the opposite side and


remove the lid.

5) Insert Junron tube ( 6 transparent) for


Separate collection tank into the cap.
6) Fix the tubes with insulation locks in the
parts box and fasten the cap.

Note;
Cut the tube until appropriate length if it is too, long.
If the tube for Waste tank is fixed on the waste tank cap, the tube may come off
due to too, short insertion amount. Be careful that too, long insertion amount of
the tube causes a lot of foaming.

21
V1.4

11. Electric wiring and tubing

Cables and tubing for water supply, detergents and waste are connected.

11.1 Tubing connection

Note;
・Water supply tank, Waste tank and Separate collection tank must be set
below the analyzer level.
Water purified system must be set below the analyzer level or the same
level when the system is directly connected to the analyzer.
・Detergent tanks must be set below the analyzer level or the same level.

① Installation layout example

Detergent tank

Water supply tank


Waste tank
Separate collection
tank

② Connection between tanks and water supply/waste panels

Water supply/drain panel

Right side

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Setup Manual

<Water supply/waste panel>

Upper: Signal line (SW-1 to 5), sensor cable are connected.


Lower: tubing line (WAST1 to ACID), tubing are connected.

SW-1 Waste tank


SW-2 Separate collection tank
SW-3 Water supply tank
SW-4 Detergent tank (alkaline)
SW-5 Detergent tank (acid)

Poalon tube 3.2 (transparent)


ALKALIN= Alkaline detergent tank
Vinyl tube 10 ACID = Acid detergent tank
(transparent)
Waste tank for overflow
Junron tube ( 6 blue)
Junron tube ( 6 transparent) Water supply tank
WAST-1 = Waste tank
WAST-2 = Separate collection tank

① Tubing and Sensor cable is connected with Water supply/drain panel.

Sensor cable

Junron tube Vinyl tube Poalon tube


Water supply tank tube (blue) Overflow tube (transparent) Detergent tubes
Waste tube (transparent) (transparent)
Separate collection tube (transparent)

23
V1.4

② Each tube is pulled around to tanks in order not to be folded or squashed.


Fix tubes with insulation locks in the part box as needed.

③ If the analyzer has Electrolyte (ISE) unit, insert ISE drain tube into ISE waste bottle.
Firmly insert the tube to the base.

Tygon tube for ISE waste bottle

ISE waste bottle

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Setup Manual

11.2 Connection of Power cable

Precautions
Electric variation should be small. (within +/-10V)
No high frequency electromagnetic emission apparatus nearby. (Centrifuge,
Discharge equipment etc.)
The room should have an electrical outlet which can be inserted with the
ground terminal class-D. (installation resistance is 100 ohm or less)
Power supply capacity should be 600VA and more.
Absolutely avoid multiple-tap electricity from a single outlet.
Do not use no rated cord for power supply
Rating) 125V 7A and more for AC 100V/115V, 250V 3.5V and more for AC
220V/230V
Firmly insert the cord all the way.
Main switch should be OFF before inserting Power cord.
Do not use Power cable with the analyzer for other instruments.

Connection of Power cable


1) Confirm that Main switch is OFF.
Turn it off if it is on.
2) Insert the attached Power cable into AC input, and insert AC plug in the
opposite side into an electric outlet of AC100V.
3) Connect the attached LAN cable into the designated position of PC.
4) Connect AC adaptor of PC to an electric outlet.

Left side Main power switch panel

Main power switch panel


A: LAN ----------------------------- Connect LAN cable here.
B: Main power switch
C: Fuse ----------------------------- Time lag fuse (AC250V 6.3A)
D: AC input ----------------------- Connect AC plug here.

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V1.4

12. Setup of Electrolyte (ISE) unit

12.1 Preparation of electrode (removal of bubble)

If the electrode has a bubble inside, measuring results are not correct.
Remove bubbles when installing electrodes. The followings describe Ref.
electrode as an example. The same procedure is followed for the other
electrodes.
1) Take out electrodes (Na, K, Cl and Ref electrode). Peel off seals on the joints with the
flows and a seal on the air vent of Ref electrode.
Be careful not to touch electrode metals (gold).
If glue of seal adheres to the electrodes after seals are peeled off, remove it.
2) Confirm that a rubber packing is attached in electrode joint.
Be careful that a rubber packing and a seal may be removed together. If a
rubber packing is peeled off from the electrode, attach it on the electrode
again.
3) Remove bubbles from electrode
Seal Removal procedure of electrode bubbles
① Attach a disposable tip on the syringe
of accessories and aspirate a
Seal sufficient quantity of Calibrator A or
(Top and bottom B.
of electrode) ② Insert the tip into the hole of the flow
joint of Reference (Ref) electrode.
③ Discharge the Calibrator A or B.
Air vent Syringe with Do not push the syringe at the
end, keep the Calibrator A or B a
little inside.
④ Pull out the syringe from the passage
joint. If there is still any bubble,
repeat the procedure from ③.
⑤ Wipe off the spilt liquid all over the
Electrode electrode, if any.
Passage joint metal part ⑥ Follow the same procedure for the
other electrodes.
4) Connect electrodes with attached fixing plate.
Connect all electrodes, Ref, Cl, K and Na, from bottom to top.

Fixing plate

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Setup Manual

12.2 Installation of electrodes

1) Open ISE door in the right side.


2) Open ISE cover and push down lower
fitting until locking.
3) Insert the electrodes during pushing
down fitting.
4) Open the locking and lift fitting.
Fitting If the electrodes are not properly
inserted, fitting cannot go up.
5) Confirm that fitting rises and the
electrodes are properly inserted.

After finishing 5), perform [12.3


Lock Preparation of roller pump tube] and
[12.4 installation of Calibrator 1].
Do not turn on main power supply.
After turning on main power supply,
confirm leakage in and after 6).

<Leakage test>
6) Turn on main power switch. The
Calibrator 1 is automatically sent.
Electrodes
Confirm that any leakage does not
happen.
Note;
If leakage occurs, take out the
electrodes and insert it again.
7) Close electrode cover and ISE door.

27
V1.4

12.3 Preparation of Roller pump tube

Hook 1) Loose the front screw on the top panel


and remove the front panel.

A connector is connected with the


analyzer inside of the panel.
Remove the connector before
removing front panel.
2) Remove the joint parts of the roller pump
tube from the hook and remove it from
the roller unit.
3) Thinly spread Roller pump tube grease on
the pump tubes.
Lever 4) Hang the joint part on the hook so that the
pump tube is set to the center of the roller
part.
5) Rotate 90 degrees holding lever to the
inside while pushing the lever.
6) Connect Front panel connector and
connect Front panel.

Roller pump tube


Thinly spread Roller pump tube grease.

Lever

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Setup Manual

12.4 Installation of Calibrator 1

The analyzer automatically sends Calibrator 1, once per 2 hours when Main
switch is ON, once per 30 minutes when System switch is ON, in order to
prevent dryness of the flow and the electrodes.

1) Attach Reagent hook of ISE accessories


on the right side.

2) Keeping the new Cal-1 pack upside up,


and unscrew the cap.

3) Push the pack by hand in order to remove


air and screw the cap.

4) Hang the pack on the hook.

<Leakage test>
5) Turn on Main switch and the Calibration
1 is automatically sent. Confirm that any
leakage does not happen.
Note;
If fluid leaks, retighten the
connection cap.

Calibrator hook

Calibrator 1

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V1.4

13. Start up of the analyzer

Start up the analyzer.


Procedures from start up to measurement are performed as the following steps.
In case of with electrolyte (ISE) unit, Calibrator 1 is automatically sent when Main
switch is turned on.
Check leakage in electrodes and calibrator 1 etc. when Main switch is ON.
Refer to Chapter 12. Set up of electrolyte (ISE) unit.

What is Standby? : The RCT temperature reached to 37℃.

① Log in screen

↑ ↑ ↑
③ ④ ⑤

② Main screen
Step Operation button and screen Operation and movement
Turn on Main switch.
1 -
Main switch is in the left of rear of the analyzer.
2 - Turn on PC.
The program starts and Log in screen displays.
① Input [Service] in User name and keep blank in
3 ① (Login screen)
Password.
② Select Log in button.
4 ② (Main screen) Main screen displays.
5 ③ System status monitor Confirm that the sign is [OFF LINE].
Temperature control
6 ④ Confirm that the sign is [---].
status monitor
Click the Icon.
7 ⑤ Icon (System switch)
The system is turned on.

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Setup Manual

Step Operation button and screen Operation and movement


Communication between PC and analyzer starts.
The following pop up messages display.
8 -
[Connecting] [Program downloading]
[Parameter downloading]
The communication between PC and analyzer is
9 -
completed.
10 ③ System status monitor Confirm [IDLE].
Temperature control
11 ④ Confirm [WARM-UP].
status monitor
12 - Wait until RCT reaches 37℃.
Temperature control
13 ④ Confirm [OK].
status monitor
14 - Analyzer is standby.

Monitor detail
③ [System status monitor]: Analyzer motion displays.
DISPLAY System status
OFF LINE No communication between PC and analyzer
IDLE Out of run
Analyzer is ready. (It is a state that each unit stays in the
READY
start position.)
INIT Initialization of the analyzer in motion
RUN Measuring
S.STOP Sampling stop
END Measurement is completed.
CLOT Sample probe is clogged (The clot cannot be removed).
BARCODE Reading reagent barcodes
GAIN Auto gain in motion
MAINTE Maintenance operations in motion
CRS CRS correction in motion

④ [Temperature control status monitor]: displays a state controlling RCT temperature.


DISPLAY Status
--- Not control temperature
After temperature control starts, RCT temperature does
WARM UP
not reach 37℃+/-0.1℃.
Temperature control in motion
OK
RCT temperature is within 37℃+/-0.1℃.
Temperature control in motion
NG
After [OK] displays, RCT temperature is out of 37±0.1℃.

31
V1.4

14. Confirmation and version up the FPGA version

When set up the analyzer, confirmation of the FPGA version is necessary.


If it is not the latest version, please upgrade to the latest version.

1) Confirmation of the FPGA version.


②→




③→

System − Version information − Version information screen

① Ensure the analyzer system power supply is ON.


Confirm the ① Monitor shows [IDLE] (or [READY]).
When the ① Monitor shows [OFF LINE], follow the next procedure.
Select ② button, and turns ON the analyzer system power supply.
Confirm the Monitor shows [IDLE] (or [READY]).
② Click ③ System button.
③ Select ④ Version button in system menu screen, and open the ⑤Version
information screen.

⑥→
←⑦
Version Information screen

④ Confirm the FPGA version in ⑥FPGA Version column.


⑤ Click ⑦ Exit, and close the Version Information screen.

32
Setup Manual

2) Confirmation of latest FPGA version.

Storage C:¥Program Files¥BiOLiS30i¥FPGA

(Example) TOP_CPSIF_FPGA_rev(Version number).rpd


File name When multiple files are stored, the largest number is the
latest FPGA version.

Example; FPGA file screen

3) FPGA version up procedure


For version up procedure, please refer to Chapter 5, 5.3 FPGA version up
procedure in Service manual.

33
V1.4

15. Setting of analyzer temperature correction

Set Temperature correction parameter value indicated on the back side of the front
panel of the analyzer.
① Loose the front screw on the top panel, and remove the front panel.
Confirm the correction value of temperature parameter.
A connector is connected with the analyzer inside of the panel. Remove the
connector before removing front panel.
② Displays Main screen.

③-2

③-1

Main screen

④-1 ⑤

↓④-2

Temperature screen
③ -1 Select System button.
-2 Select Temperature button.

④ -1 Input RCT [Sensor Adjust] correction value.


-2 Input WSH [Sensor Adjust] correction value.
⑤ Click Save button to save the settings.
⑥ Connect Front panel connector and connect Front panel.

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Setup Manual

16. Confirmation of Temperature control function

Confirm that Temperature control for Reagent tray (RCT) and Wash solution
preheater (WSH) are appropriately working.

16.1 Confirmation of Temperature control for Reagent tray (RCT) and Wash
solution preheater (WSH)

Temperature control function is checked at the following moments.


-Reaction tray, Wash solution preheater:
When temperature control status monitor becomes [OK],
It is 15 to 20 min after System power is turned ON.

③↓


Temperature screen
Step Operation button and screen Operation and movement
Temperature control
1 ① Confirm that [OK] displays.
status monitor

35
V1.4

Step Operation button and screen Operation and movement


2 ② System Displays Menu button of System screen
3 ③ Temperature Displays Temperature screen
Check the temperature of reaction tray
5 ④ RCT
Should be stable near 37oC
Check Temperature of Wash solution preheater
6 ⑤ WSH
Should be stable near 38oC
Operate the followings if the temperature is abnormal.

Icon
7 ⑥ Turn off System power.
(System power)

8 ⑦ System status monitor [OFF LINE] displays.

Icon
9 ⑥ Turn on System power again.
(System power)

10 - Perform step 1 to 6 again and check them.

16.2 Confirmation of Reagent tray (RGT)

Temperature control function is checked at the following moments.


-Reagents tray: 30 mins after main power is turned on.

1) Loose the front screw on the top panel, and remove front panel.
A connector is connected with the analyzer inside of the panel. Remove the
connector before removing front panel.
2) Confirm that Digital thermometer is set at 9 to 10℃.
3) Touch RGT cooling plate in reagents tray with hand and check that the unit is cool.
4) Connect front panel connector and connect front panel.

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Setup Manual

17. Initialization of analyzer (Ready)

Initialize the analyzer.


Initialize the analyzer as the following steps.
After initialization of the analyzer (Ready), confirm that all units stay in the
home positions (measurement start points).

What is the initialization of the analyzer?


All the units move to the home positions (measurement start position).
What is “Ready”?
All the units stay in the home positions (measurement start position).

Main screen

Operation button
Step Operation and movement
and screen
1 ① Ready Select Ready button.
Start initialization of the analyzer.
2 - All units move to the home positions (measurement start
positions).
System status
3 ② [INIT] displays during initialization.
monitor
4 - Initialization of the analyzer is completed.
System status
5 ② [READY] displays after initialization is completed.
monitor
The state becomes [Ready].
6 - All units stay in the home positions (measurement start
positions).

37
V1.4

18. Position check and manual operation check

Check the positional relation among probes and reaction cells.

18.1 Sample probe (STM) position check

Check the positions between sample probe and sample cups, between sample
probe and reaction cell.
If sample probe is in the center of reaction cell, ISE sample pot position is no
problem. Not need to check the position for ISE again.

① Open the top cover of the analyzer.


② Set sample tray.
③ Remove Reaction cell cover.
④ Confirm that sample probe is straight.
If it is bent, correct it to be straight.

Reaction cell cover

Sample probe
⑤ Click “Ready” button, and initialize the analyzer.
⑥ Confirm that the tip of sample probe is in the center of washing trough.


Main screen

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Setup Manual

STM screen
⑦ Select “System” button.
⑧ Select” Manual operation” in System Menu.
⑨ Select STM and open STM screen.
⑩ Confirm the position of sample probe adjusted by manual operation.
Select a button and double click it or select Run, resulting in the motion.
Movement
1 ROTATE INIT Moves to the home position.
2 OFFSET
3 Input the angle for rotation and select CW or CCW.
ROTATE ADJUST
Then it rotates clockwise or counterclockwise by the
angle.
4 ROTATE REACTION CELL Moves to Reaction cell.
5 ROTATE DILUTION CELL Moves to Dilution cell.
6 ROTATE WASH Moves to Washing trough.
7 ROTATE SAMPLE ( OUT) Moves to Outside cup of STF, sampling position.
8 ROTATE SAMPLE ( IN) Moves to Inside cup of STF, sampling position.
9 ROTATE SAMPLE ( ISE) Moves to ISE sample pot.
10 UP/DOWN INIT Moves to the home position.
11 UP/DOWN ADJUST Input the distance to move and select UP/Down. Then
it moves the distance upward or downward.
12 UP Goes up the distance from the home position.
13 Goes down to the position where Sample probe
DOWN Wash1
washed.
Goes down to the position where Sample probe
14 DOWN Wash2
washed when blood cell used.

39
V1.4

Movement
Goes down to the position where water is dispensed
15 DOWN Wash3
when Sample probe washed.
Goes to the position where Sample is dispensed in the
16 DOWN Reaction cell
reaction cell.
Goes down to the position where Diluted sample is
17 DOWN Dilution cell
dispensed in the reaction cell.
Goes down to the cup position. (liquid surface
18 DOWN CUP(Level)
detection)
Goes down to Test tube position. (liquid surface
19 DOWN Sample tube(Level)
detection)
20 DOWN Trace samples( Level) Goes down to micro cup position.
21 DOWN ISE Goes down to ISE sample pot position.

Movement
Selected when each operation is performed without
Cancel Safety
Safety.
RUN Performs the selected motion.

Reaction cell position


Outside cup position
Inside cup position

ISE sample pot position

Probe washing trough position

Confirm that Sample probe is in the center of Inside/Outside sample cup,


Reaction cell, Washing trough, and ISE sample pot.

If Sample probe is Not in the center,


① Adjust STM position so that sample probe is in the center of reaction cell and
ISE sample pot.
② Adjust STF position so that sample probe is in the center of outside cup and
inside cup.
③ Adjust probe washing trough position so that sample probe is in the center of
probe washing trough.

40
Setup Manual

18.2 Reagent probe (RTM) position check

Confirm the positions between reagent probes (R1/R2 probe) and reagent
bottle, between the probes and reaction cell.

① Open the top cover of the analyzer.


② Remove Reaction cell cover.
③ Set 2 reagent bottles in #1 position of reagent tray. (R1 bottle and R2 bottle)
④ Confirm that R1/R2 probe are straight.
If it is bent, correct it to be straight.

Reaction cell cover

Reagent probe

⑤ Click “Ready” button and initialize the analyzer.


⑥ Confirm that the tip of R1 probe is in the center of washing trough.

④ →

Main screen

41
V1.4


RTM screen
⑦ Select “System” button.
⑧ Select “Manual operation” in “System Menu”.
⑨ Select RTM and open RTM screen.
⑩ Confirm the position of reagent probe by manual operation.
Select a button and double click it or select “Run” button, resulting in the
motion.
Movement
1 ROTATE INIT Moves to the home position on reaction cell.
2 ROTATE OFFSET
3 Input the angle for rotation and select CW or
ROTATE ADJUST
CCW. Then it rotates clockwise or
counterclockwise by the angle.
4 R1 ROTATE REACTION CELL Moves to R1 reaction cell.
5 R1 ROTATE WASHING WASH Moves to R1 washing trough position.
6 R1 ROTATE BOTTOLE ( IN) Moves to R1 aspirating position
7 R2 ROTATE REACTION CELL Moves to R2 reaction cell position.
8 R2 ROTATE WASHING WASH Goes to R2 washing trough position.
9 R2 ROTATE BOTTOLE ( OUT) Moves to R2 aspirating position
10 UP/DOWN INIT Moves to the home position.
11 UP/DOWN ADJUST Input the distance to move and select UP/Down.
Then it moves the distance upward or downward.
12 UP Goes up the distance from the home position.
13 R1 DOWN WASH Goes down to R1 washing trough.
14 R1 DOWN REACTION CELL Goes down to R1 reaction cell position.
Goes down to R1 reagent bottle position. (liquid
15 R1 DOWN BOTTLE (LEVEL)
surface detection)

42
Setup Manual

Movement
16 R2 DOWN WASH Goes down to R2 washing trough.
17 R2 DOWN REACTION CELL Goes down to R2 reaction cell position.
Goes down to R2 reagent bottle position. (liquid
18 R2 DOWN BOTTLE(LEVEL)
surface detection)

Movement
Selected when each operation is performed without
Cancel Safety
Safety.
RUN Performs the selected motion.

Reaction cell position

Probe washing trough position

R1 reagent bottle position

R1 probe position check

Reaction cell position

Probe washing trough position

R2 reagent bottle position

R2 probe position check

Confirm that R1/R2 probe are in the center of R1/R2 reagent bottle taps, reaction cell
and Washing trough.
If reagent probe is not in the center, correct it.
① Adjust RTM position so that Reagent probe is in the center of reaction cell.
② Adjust washing trough position so that reagent probe is in the center of
washing trough.
③ At first, confirm that R2 probe is in the center of reaction cell. If the probe is
not in the center, adjust R2 probe position.
④ At first, confirm that R1 probe is in the center of Reagent bottle. If the probe
is not in the center, adjust RGT position.

43
V1.4

18.3 Cell washing station (CWS) position check

Check the positions of Cell washing station and Reaction cell.

Reaction cell cover

Cell washing nozzle

Drying tip

Fixing nut

Nozzle base

① Open the top cover of the analyzer.


② Remove Reaction cell cover.
③ Click “Ready” button and initialize the analyzer.


Main screen

44
Setup Manual

CWS screen

④ Select System button.


⑤ Select Manual operation in System Menu.
⑥ Select CWS and CWS screen is opened.
⑦ Check CWS position by manual operation.
Select a button and double click it or select Run button, resulting in the motion.
⑧ Check with eyes the followings. When Cell washing station goes down, Cell drying tip and
cell washing nozzle are in the center of Reaction cells, and do Not touch the cells. And
they smoothly move up and down.

If the position is wrong, remove top panel.


① Remove top panel.
② Slightly loosen Fixing screws and adjust Nozzle base position so that Cell washing
nozzle and drying tip are in the center of Reaction cell and they do not touch the cells.
But, move so that not Contact at the Reaction cell center.
③ After the adjustment is completed, fix them in the reverse order of above procedures.

Movement
1 INIT Moves to the home position.
ADJUST Input the distance to move and select UP/Down. Then
2
it moves the distance upward or downward.
DOWN BOTTOM
3 Lowers CWS to the bottom.
POSITION
UP DISCHARGE
4 Goes up to the dispensing position
POSITION
5 UP HOME POSITION Goes up to the home position

Movement
Selected when each operation is performed without
Cancel Safety
Safety.
RUN Performs the selected motion.

45
V1.4

18.4 Mixing unit (MU) position check

Check the positions of Mixing unit and Reaction cell.

Reaction cell cover

Fixing nut

Positioning plate Mixing nozzle

Mixing base
Gasket base

Gasket

*
While MU is in the lowest position, the
gasket should completely cover one side
① Open the top cover of the analyzer. of Reaction cell.

② Remove Reaction cell cover.


③ Click “Ready” button and initialize the analyzer.


Main screen

46
Setup Manual

MU screen

④ Select System button.


⑤ Select Manual operation in System Menu.
⑥ Select MU and open MU screen.
Select a button and double click it or select Run, resulting in the motion.
⑦ -1 Check with eyes that the gasket completely covers one side of reaction cell after mixing
unit is lowered by manual operation.is identified by visual inspection.
-2 Check with eyes that mixing nozzle can move upward the distance from 1 to 1.5mm after
the unit is lowered by manual operation. Check by visual inspection.
-3 Confirm that the tip of mixing nozzle is lower around 0.1mm than the gasket.
Adjust the upward motion of mixing nozzle and the allowance of the tip of mixing
nozzle by screwing the gasket into the base.
If the gasket position is wrong,
① Remove top panel.
② Input "900" in ADJUST field. Select Down Run. And MU goes down.
③ Loosen fixing nut and move mixing base by adjusting positioning plate. Set so
that take reaction cell center.
④ After the adjustment is completed, fix them in the reverse order of above
procedures.

Operation button and screen Movement


1 INIT Moves to the home position.
ADJUST Input the distance to move and select UP/Down. Then
2
it moves the distance upward or downward.
3 UP Goes up the distance of the set pulse from Reaction cell.
4 DOWN Goes down the distance of the set pulse to Reaction cell.

Movement
Selected when each operation is performed without
Cancel Safety
Safety.
RUN Performs the selected motion.

47
V1.4

18.5 Setting the maximum descent position of the sample probe when
measuring sample with cup on tube

When measuring the sample with cup on tube, set the maximum descent position
of the sample probe according to the type of the primary tube to be used.

18.5.1 Determination of the number of pulses


Check the position of the sample probe while lowering the sample probe by
manual operation, and calculate the number of pulse at the maximum descent
position according to the type of the primary tube to be used.

⑦→
④→

⑤↓

③→

⑨↓ ⑥↓ ①→
②→ ⑧↓ ⑧’↓

Manual Operation―STM screen

Step Button & Screen Operation & Display

1 Place an empty sample cup on the primary tube to be used and place it in Pos.1 of the
sample tray.
2 ① Ready Click “Ready” button.
3 ② System Click “System” button.
4 ③ Manual Operation Click “Manual Operation” button.
5 ④ STM Click “STM” button.
6 ⑤ ROTATE SAMPLE(OUT) Click “ROTATE SAMPLE (OUT)” button.
7 ⑥ RUN Click “RUN” button.
8 ⑦ UP/DOWN ADJUST Click “UP/DOWN ADJUST” button.
Enter an arbitrary number of pulse in □.
9 ⑧ 0 ×0.02625mm The sample probe moves the distance (mm)
displayed in ⑧’.
10 ⑨ UP ⇔ Down Select "UP" button to switch to "DOWN".
11 RUN Select "Run" button to lower the sample probe.
12 ⑨ Down ⇔ UP Select "DOWN" button to switch to "UP".
13 RUN Select "RUN" button to lift up the sample probe.
Repeat Step 9 to 13 to determine the number of pulses at the lowest point of the
14 sample probe so that the sample probe tip is about 2 mm from the bottom of the sample
cup.
15 ① Ready Click “Ready” button.

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Setup Manual

18.5.2 Setting the number of pulses

Set the maximum descent position of the sample probe when cup on tube.
Select and set the number of pulses determined in 17.5.1 in the parameter field of
Initialization screen.

②↓

①→

←③

④↓

Initialization screen

Step Button & Screen Operation & Display


1 ① System Click “System” button.
2 ② Initialization Click “Initialization” button.
Parameter Select and set the number of pulse.
3 ③
[Maximum descent of cup on tube] Default is 2400 pulses (63 mm down).
4 ④ Save Click “Save” button.

49
V1.4

18.5.3 Check the maximum descent position

Check the maximum descent position of the sample probe.

⑦→
④→

⑤↓

③→

⑥↓ ①→
②→

Manual Operation―STM screen

Step Button & Screen Operation & Display


Place an empty sample cup on the primary tube to be used and place the sample cup
1
in Pos.1 of the sample tray.
2 ① Ready Click “Ready” button.
3 ② System Click “System” button.
4 ③ Manual Operation Click “Manual Operation” button.
5 ④ STM Click “STM” button.
6 ⑤ ROTATE SAMPLE(OUT) Click “ROTATE SAMPLE (OUT)” button.
7 ⑥ RUN Click “RUN” button.
DOWN Trace samples
8 ⑦ Click “DOWN Trace samples (Level)” button.
(Level)
9 RUN Select "RUN" button to lower the sample probe.
Check that the sample probe tip is about 2 mm from the bottom of the sample cup.
10 If the tip is not in the proper position, set the pulse number to change the
position.
11 ① Ready Click “Ready” button.

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Setup Manual

19. Prime (filling tubing with water)

After position check and motion check are completed, perform to fill tubing with
water.

① ②

Maintenance screen

Step Operation button and screen Operation and movement


1 ① Maintenance Select “Maintenance” button.
2 ② Prime Select [Prime] button in “Maintenance” screen.
Start “Prime” movement.
Confirm no liquid outage and no dripping from
sample probe, reagent probes and cell washing
3 ③ −
nozzles when water is discharged.

Required time: around 3 minutes


When the movement is completed,
4 −
1) Confirm that all tubing is filled with water.

51
V1.4

20. Air removal of the clot sensor

Procedure of air removal from clot sensor is as follows.


Gloves、Syringe(5ml)、Tip、Paper wiper
Necessary parts
(Parts:Code 60-22-0269) Air removal tool for clot sensor

1) Preparation of jig.
Prepare the air removing jig for clot sensor. Connect the syringe to air
removing jig.

(1) Air removal tool for clot sensor (Code 60-22-0269)


This tool consists of socket, packing, joint and POALON tube
(1 , 35 cm)

POALON Tube joint packing socket packing

(2) Connect the tip (Cut about 45mm) to Syringe (5mL).

Note: Do not use syringe other than 5 mL size. If the size is


larger than 5 mL, clot sensor will be damaged.

The tip (Cut about 45mm) fix firmly.

45mm
Connect to Poalon tube

Tip Syringe(5mL)

(3) Connect ① Air removal tool for clot sensor and ② syringe and tip to
complete the air removal jig

Air removing jig

52
Setup Manual

2) Air removal procedure


①→

②→

Main screen

(1) Check the DI water volume which is


enough in water supply tank.
(2) Turn on the main power supply.
(3) Start the system program
(4) ( )①Turns ON the system power
Claw→ supply.
(5) ② Click [READY] to initialize the
analyzer.
STM arm cover
(6) Open the top cover

(7) Remove the STM arm cover.


By pressing the claw to outside
Claw→ lightly, and pull up.
Be careful not to spread too much
to prevent the damage.

Joint part

View after removed the STM arm cover

53
V1.4

(8) Fix the probe site by hand, and


remove the joint by turning to
counter clockwise direction.

(9) Connect the joint parts (Teflon tube)


to socket parts of air removing jig.

Socket part of air removing jig Joint parts

←⑤

③→

(10) Select ③ [System]button.


(11) Select ④ [Manual operation]button.
(12) Select ⑤ [SP] button.
(13) Open SP Manual operation screen.

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Setup Manual

⑦→
⑥→ ⑨→
⑧→

⑩↓ ⑪→

(14) Select ⑥[WASH PULL(1000µL)] button click ⑩[Run]button


(15) Select ⑦[SV1 ON]button click ⑩[Run]button
(16) Select⑧[WASH PUSH(1000µL)] button click ⑩[Run]button
(17) Select⑨[SV1 OFF] button click ⑩[Run]button
(18) Pull syringe to 3 mL, and release. Repeat this 5 times.
Syringe will automatically move back to the initial position when released.
(19) Pull the syringe and keep it at 3mL line then remove the syringe from the
POALON tube. Discard water inside the syringe.
(20) Reattach syringe to POALON tube again.
(21) Repeat the step 13) ~18) 6 times.
(22) Disconnect the air removal jig from Teflon tube
(23) Fix the joint to sample probe.

Replace the STM arm cover.


(24) Insert the arm cover hook to arm rear
hole.

Rear side hole on the STM arm

(25) Close the cover to fixing the hook.


(26) ⑪Click “Ready”.
(27) Open maintenance screen by clicking
“Maintenance” button.
(28) Click “Prime” button, and confirm no
error during the priming.

Rear side claw on the STM arm

Note: Even if repeating above procedures does not remove air from clot sensor,
or continues to entrap air, air may be entering from the membrane or the
joint area. In such case, replacement of the clot sensor is recommended.

55
V1.4

21. Special wash

Perform Special wash to check its movement and to remove air from flows.
Special wash is to perform measurement by dispensing detergent instead of
sample and reagent, resulting in washing probes and Reaction cells.
Use an Alkaline detergent of Probe & Cell Wash.

Special wash procedures


1) Prepare reagent bottles and a sample cup.
Pour alkaline detergents of Probe & Cell Wash around 20mL into R1 reagent
bottle, around 11mL into R2 reagent bottle and around 2mL into a sample cup.

2) Set conditions about reagent bottles.

① ④


Reagent screen-Reagent setting screen

Step Operation button and screen Operation and movement


1 ① Reagent Select Reagent button.
2 ② Reagent settings Select “Reagent settings” button.
Round name: Set Reagent round.
3 ③
(Round name) Select Round number and input a round name.
Set Reagent bottle positions
④ (1 to 36) ④ Select from 1 to 36 of bottle positions. (It turns
4
⑤ (Item name) blue when it is selected.)
⑤ Select Wash1in the right side of the screen.
Check the settings about the reagent positions.
5 ④ (1 to 36) Wash1 displays under the bottle number set in
Step 4.
6 ⑥ Save Save the settings about reagent bottles.

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Setup Manual

②.


Reagents screen-Reagent information screen

Step Operation button and screen Operation and movement

7 ② Reagent information Select Reagent information button.


Check the settings about the reagent positions.
8 ④ (1 to 36) Reagent tray position number, Item number, Item
name etc.
Put the reagent bottles in the position checked in Step
9 −
8.
Select Fill or Fill All and the reagent remains will be
10 ⑤ Fill or Fill All
updated.

11 ⑥ Save Save the reagent remains.

3) Set the sample cup prepared in 1) in W1 of Sample tray.


4) Perform Special wash.

① ② ③

Maintenance screen

57
V1.4

Step Operation button and screen Operation and movement


1 ① Maintenance Select Maintenance button.
2 ② Special wash 1 Select [Special wash 1] in Maintenance screen.
Start Special wash.
3 ③ −
Required time: around 30 minutes
4 − The washing motion is completed.

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Setup Manual

22. Auto gain (Gain adjustment)

Note; After light intensity becomes stable (20 to 30 min after the analyzer
starts), perform Auto-gain (Gain adjustment).

1) Wait for 20 to 30 minutes after the analyzer starts until the light intensity
becomes stable.
Refer to 13. Start up (analyzer start) about starting the analyzer.

Maintenance screen
2) ① Select Maintenance button and open Maintenance screen.
3) ② Select Auto gain button.
4) The analyzer works and displays the confirmation screen by popup.

Fixing nut

Confirmation screen Cell holder

5) Remove Cell cover. And remove cell holder by loosening fixing nuts with a
hexagonal wrench (2.5mm).
6) According to the direction of the confirmation screen, remove the position
number 50 cell of reaction tray.
Note; Be careful in order not to touch the measuring side of the removed cell.

Reaction tray Auto gain information screen


59
V1.4

7) Select OK button of the confirmation screen.


8) Light intensity is automatically adjusted at all wave lengths.
9) Auto gain information (gain value etc.) displays in the screen.
10) After Auto gain is completed, confirmation screen for data save displays by
pop up.

Confirmation screen
If Auto gain failed,
① The error screen popped up. Close the error screen.
② The back color of failure value about Auto gain changes to red in Auto
gain information screen. Select Cancel in the confirmation screen for
data save.

Countermeasure
① Check No foreign material in the measuring side of the number 50 cell
of Reaction tray.
If any foreign material exists there, remove it with air blower. And
perform Auto gain again.
② Replace a lamp and perform Auto gain again.

11) Select OK in the confirmation screen for Data save and save the data.
12) Return the reaction cell removed in 6).
13) Return Cell holder and Cell cover.

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Setup Manual

23. Test run

23.1 Water blank measurement

Perform Water blank measurement and check the data.

① ③

Item screen-Optical screen

1) Prepare 2 reagent bottles with surfactant solution (single type) and 12 sample cups.
2) Input item parameters for Water blank.
① Select Item.
② Select Optical.
③ Input item parameters for Water blank. (Water blank 1, 2)
④ Click Save button to save the parameters.
<Water blank item parameters>
Water blank
Water blank Water blank
Item name
1 2
Data information Unit 1 1
Digits 0 0
Analysis Method END END
Main wavelength 340 600
Sub wavelength 405 700
Calibration Method Factors Factors
Factors value 1 1
Volume Method Single Single
Sample 2 2
Reagent 1 200 200
Data processing Main read start 51 51
Main read end 54 54
Sub read start - -
Sub read end - -

3) Set reagents and put Reagent bottles for Water blank 1 and 2 in RGT.

61
V1.4

① ④

Reagent screen-Reagent setting screen

Step Operation button and screen Operation and movement


1 ① Reagent Select “Reagent” button.
2 ② Reagent settings Select “Reagent settings” button.
Round name: Set Reagent round.
3 ③
(Round name) Select Round number and input a round name.
Set Reagent bottle positions
(1 to 36) ④ Select from 1 to 36 of bottle positions. (It turns
4 ④
(Item name) blue when it is selected.)

⑤ Select Item name in right side of the screen.
Check the settings about the reagent positions.
5 ④ (1 to 36) The item name displays under the bottle number
set in Step 4.
6 ⑥ Save Save the settings about reagent bottles.


⑤ ↓

Reagents screen-Reagent information screen

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Setup Manual

Step Operation button and screen Operation and movement

7 ② Reagent information Select Reagent information button.


Check the settings about the reagent positions.
8 ④ (1 to 36) Reagent tray position number, Item number, Item
name etc.
Put the reagent bottles in the position checked in Step
9 -
8.
Select Fill or Fill All and the reagent remains will be
10 ⑤ Fill or Fill All
updated.

11 ⑥ Save Save the reagent remains.

4) Perform Test order. (Each Water blank 1, water blanks 2, N=60)



① ④


Order screen
Order of Water blank 1
① Select Order.
② Select Tray 1 and Position 1. ⑦
③ Select the item.

④ Select the number 10 in Repeat.
⑤ Select Water blank 1. Group order screen
⑥ Select Group order.
⑦ Select the number 6 in End Sample No. field in Group order screen.
⑧ Select OK.
Order of Water blank 2
② Select Tray 1 and Position 7.
③ Select the item.
④ Select the number 10 in Repeat.
⑤ Select Water blank 2.
⑥ Select Group order.
⑦ Select the number 12 in End Sample No. field in Group order screen.
⑧ Select OK.

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V1.4

5) Put the sample cups prepared in 1) in sample position 1 to 12 of Sample tray.



In time of main screen – general tray selecting

6) ① Select Main screen.


② Select Patient sample tray.
③ , in, was entry TRAY X 1 is chosen
④ Select Start button to start measurement.
⑤ Select Result Log and display the results.
7) Check the range of the results about Water blanks.
Water blank 1 = within Abs.0.0100
Water blank 2 = within Abs.0.0050

If the result is over the threshold, perform procedures from 18. Prime (Filling tubing
with water) again.

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Setup Manual

23.2 Test Item measurement

Check data by measuring test Items for data confirmation as needed. The
following examples are measurements of TP and LDH as test Items.

1) Input item parameters.

① ③

Item screen-Optical screen

① Select Item.
② Select Optical.
③ Input item parameters.
④ Click Save button to save the parameters.
Example; Item parameters
Item
Item name TP LDH
Data information Unit g/100ml IU/L
Digits 1 0
Analysis Method END RATE
Main wavelength 546 340
Sub wavelength 700 405
Calibration Method Linear1 Linear1
Volume Method Double Double
Sample 2.0 4.0
Reagent 1 180 160
Reagent 2 90 40
Data processing Main read start 51 36
Main read end 54 43
Sub read start - -
Sub read end - -
2) Prepare reagent bottles and samples (calibrators and controls).
3) Set parameters of reagents and put bottles in RGT.

65
V1.4

① ④

Reagent screen-Reagent setting screen

Step Operation button and screen Operation and movement


1 ① Reagent Select Reagent button.
2 ② Reagent settings Select Reagent setting button.
Round name: Set Reagent round.
3 ③
(Round name) Select Round number and input a round name.
Set Reagent bottle positions
(1 to 36) ④ Select from 1 to 36 of bottle positions. (It turns
4 ④
(Item name) blue when it is selected.)

⑤ Select Item name in right side of the screen.
Check the settings about the reagent positions.
5 ④ (1 to 36) The item name displays under the bottle number
set in Step 4.
6 ⑥ Save Save the settings about reagent bottles.

Reagents screen-Reagent information screen

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Setup Manual

Step Operation button and screen Operation and movement

7 ② Reagent information Select Reagent information button.


Check the settings about the reagent positions.
8 ④ (1 to 36) Reagent tray position number, Item number, Item
name etc.
Put the reagent bottles in the position checked in Step
9 -
8.
Select Fill or Fill All and the reagent remains will be
10 ⑤ Fill or Fill All
updated.

11 ⑥ Save Save the reagent remains.

4) Set calibration information (position, repeat number etc.) and input the density of the
calibrator.


CAL screen

CAL screen – Standard screen

① Select Calibration
② Select Calibration settings
③ Input Item name, Specimen, Sample tray (C1), Sample tray position, Repeat, Blank
concentration and Calibrator concentration.
Value, calibrator concentration value is configured
④ Click Save button to save the data.
⑤ Select Close button to return to Calibration screen.

67
V1.4

5) Calibration order

Calibration screen

① Check in the order field of the item. (Blue means "ordered".)


② Click Save button to save the order.

6) Measure the Calibration.

① ②

Main screen-In case of selecting Calibration tray

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Setup Manual

① Select Main button.


② Select Calibration tray.
③ in, C1 is chosen
A color of a sample position turns blue in ordering calibration.
④ Put sample cups of blank sample and calibrator in the sample tray.
⑤ Select Start button and start measurements.

7) Order measurements of calibrator and blank as patient samples and controls.


① Select Order.
② Select Tray and position.
③ Select the item.
④ Select Repeat.
⑤ Select Test items.
⑥ Select Order button.
If multiple samples are measured, perform Step 2 to 6 again.



① ④

Order screen

8) Put sample cups with ordered samples in ordered positions.



In time of main screen – general tray selecting


69
V1.4

① Select Main screen.


② Select Patient sample tray.
③ , in, was entry TRAY No.is chosen
④ Select Start button to start measurement.

9) Check the results.


Refer to the specifications for each Item to check the results.

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Setup Manual

24. ISE Calibration

Plasma sample calibration is shared for serum sample one. Perform serum sample
calibration.



Calibration screen
4.


7.

Main screen-In case of selecting Calibration tray

71
V1.4

1) Confirm No error before performing calibration.


2) Electrolyte (ISE) calibration is performed as below.

Step Operation button and screen Operation and movement

1 ① Calibration Select a calibration curve.


2 ② Specimen Select Specimen.

Confirm the order of calibration.


3 ③ Order
Blue in check box means "ordered".

4 ④ Main Select Main.


(Yellow tray)
5 ⑤ Select Calibration tray icon.
Calibration tray icon
(Yellow tray)
6 ⑥ Focus on Calibration tray icon and enlarge it.
Calibration tray icon
(Yellow tray)
7 ⑦ in, C1 tray is chosen
Calibration tray icon
Put Sample cups with Calibrator in Sample tray.
(250uL/cup)
Ordered samples turn blue in Sample tray
screen.

8 − Calibration position of electrolyte (ISE) is fixed.


ISE C1 = Calibrator A (for serum sample)
ISE C2 = Calibrator B (for serum sample)
ISE U1 = Urine calibrator 1 (for urine sample)
ISE U2 = Urine calibrator 2 (for urine sample)
ISE D = Dialysis calibrator (for dialysis sample)

9 ⑧ Measurement start Select Start button.


10 - Start calibration measurement.
In operation [RUN] displays.
11
Sampling is completed. [S.STOP] displays.
⑨ System status monitor
Calibration measurement is completed. [END]
12
displays.
⑩ Confirm that the calibration results are within the
specifications.
Calibration range (Slope)
Serum Urine
Or Na 30.37-73.40 30.37-73.44
13
K 29.45-69.46 29.46-69.46
Cl 21.01-68.71 21.01-68.71

⑪ ISE graph Select ISE graph button and confirm that the results
are within the range in the graph.

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Setup Manual

ISE graph screen

In case of serum or urine, the vertical axis of the graph is fixed to the upper or
lower limit in the calibration range.

73
V1.4

25. ISE correction procedure by the ISE CRS

In order to ensure the reliability of the ISE test results, confirmation and correction
based on the results of the ISE CRS measurement are necessary.
The ISE CRS is a standard Calibrator of the ISE method which is used for the
correction of accuracy to the ISE measurement result.



④ ⑥

Maintenance screen –CRS parameters screen

1) Confirm that the calibration of the specimen to be measured is correct before ISE
CRS correction measurement.
Refer to Calibration in 22. ISE Item. Reference ISE Items calibration.

2) ISE CRS correction measurement method


Step Operation button and screen Operation and movement
1 ① Maintenance Select Maintenance button.
2 ② ISE CRS Select ISE CRS button.
Select or input measurement parameters in CRS
parameter screen.
-Select a measuring Specimen from Serum, Urine and
3 ③ CRS parameter Plasma.
-Select 5 from 3-10 of Repeat.
-Input the Na, K and Cl conc. of low (L), medium (M) and
high (H).
Put sample cups with samples of low, medium or high in
Sample tray.
If repeat is set in N =5, pour around 500uL of
samples in the cups.
4 −
Sample tray position of CRS measurement is fixed.
31: Low concentration sample
32: Medium concentration sample
33: High concentration sample

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Setup Manual

Step Operation button and screen Operation and movement


5 ④ Start Select Start button, and start CRS measurement.
6 ⑤ Status "CRS Measuring" displays.
When the measurement is completed, "CRS succeeded"
or "CRS failed" displays.
7 ⑤ Status
If "CRS failed" displays, measure it again after
removing the cause of the error.
8 ⑥ Close Close CRS parameter screen.
CRS correction value is automatically calculated from
9 − measurement results and it is set as a parameter.
However, the correction value does not display.
Measure CRS as a sample.
Confirm that the results are within the CRS
specifications as below.
Refer to 21. Test run about the measurement
method.
10 −
Na: within certified value ±1.5mEq/L
K: within certified value ±0.1mEq/L
Cl: within certified value ±1.5mEq/L
If the results are out of the specifications, measure
ISE CRS again.
11 − Measure a control in order to check the values.

75
V1.4

26. Confirmation of the CRS correction

The CRS correction screen is protected by password. Input or change the value is
unable.

②↓ ④→
③↓
①→ ⑤↓

⑥↓
Manual operation – ISE screen
←⑦

⑧→

⑨→
CRS correction screen
Operation button
Step Operation and movement
and screen
1 ① System Click “System” button.
Manual
2 ② Select “Manual Operation” button.
Operation
Select “ISE” button.
3 ③ ISE
Manual operation – ISE screen is shown.
4 ④ CRS view Select “CRS view” button.
Select “RUN” button.
5 ⑤ RUN
Password input screen is shown.
6 ⑥ ― Input the password [9uS&4k#AFs8v].
7 ⑦ OK Click “OK” button.
CRS correction screen is shown.
8 ⑧ Specimen Select the Specimen (Serum, Urine, Plasma) by button.
Input or change the value is unable.
9 ⑨ Exit Click “Exit” button, and close the screen.

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Setup Manual

27. Creation of Maintenance list

Make “Maintenance list” in order to ensure daily maintenance and exchange work.
Manage it by updating after the works.
Refer to daily maintenance and exchange work list regarding to user's work.



⑥ ③ ⑦ ⑧

Maintenance list screen

1) Maintenance list creation method


Operation button
Step Operation and movement
and screen
1 ① System Open “System” screen.
2 ② Maintenance list Open “Maintenance list” screen.
Select Working frequency.
3 ③
(Daily, Weekly, Monthly, 3 month, Half year, 1 year and 2 years)
4 ④ Contents Select or input maintenance works.
5 ⑤ Save Saves the contents.

2) Updating method of “Maintenance list”


Step Operation button and screen Operation and movement
1 ① System Open System screen.
2 ② Maintenance list Open Maintenance list screen.
3 ⑥ Check box After maintenance work, check a box R.
Update working date of the contents checked in 6. And
⑤ Save
next working date.
4
⑦ Latest Check Date Update displays.
⑧ Expiration Date Next working day displays.

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V1.4

27.1 Daily maintenance and exchange work list

Periodic check list (for customer)

dairy

week

need
year
mth

mth

mth
Contents

if
1

1
1 Cleaning of sample probe ○
2 Cleaning of reagent probe ○
3 Check of the reagent tray cooling ○
4 Check of the water supply tank volume ○
Check of the volume Alkaline detergent tank
5 ○
Check of the volume Acid detergent tank
6 Check of the drainage tank volume ○
7 Cleaning and check of the strain of the cell cover ○
8 Cleaning of cooling filter. ○ ○
9 Special washing (Probe and cell wash) ○ ○
10 Probe wash ○
11 Check of the SP water leak ○
12 Check of the RP water leak ○
13 Check of the PWP water leak ○
ISE unit
14 Check the Calibrator 1 remaining ○
15 Check the ISE waste bottle ○
16 Cleaning of sample pot. ○
17 Cleaning of ISE sample line ○

Periodic exchange list (for customer)


dairy

week

need
year
mth

mth

mth

Contents
if
1

1 Exchange of reaction cells ○


2 Exchange of lamp ○
3 Exchange of sample probe ○
4 Exchange of reagent probe ○
5 Exchange of water filter ○
ISE unit
6 Exchange of Cal 1 pack 〇 ○
7 Exchange of Na electrode ○
8 Exchange of K electrode ○
9 Exchange of Cl electrode ○
10 Exchange of Ref. electrode ○
11 Exchange of roller pump tube. ○
12 Exchange of pinch valve tube. ○

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Setup Manual

28. Settings for user operation

Optional function, authority and user level are set according to user's operating policy.

28.1 Implementation setting method

Confirm such settings, optional setting (electrolyte (ISE), barcode, reagent


remains (in count or liquid detection mode). Change the settings as needed.
Set the parameters in System setting screen.

Main screen

③ System setting screen


① Select System button.
② Select System setting button.
③ Confirm the implementation function and settings. Change them according to
user's operating policy.
④ Click Save button to save the settings.
If the language is changed, reboot the system after selecting Save button.

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V1.4

28.2 Authorization for analyzer operation settings

Set the use authority for users.


Default setting of use authority is User Level 1 (user name [Service], can use
all operations). Set the authority according to user's operating policy.
Set the parameters in Authority setting screen.
For User level and Password settings, refer to 25.3 User level and Password.

Main screen

③ Authority settings screen

① Select System button.


② Select Authority settings button.
③ You can use the operations with レ of [Service], [Manager] and [User] in
Authority settings screen. Change them according to methods of operation.
④ Select Save button to save the settings.

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Setup Manual

28.3 Setting of user level and password

Set User level.


User level is divided into 3 levels. Default setting is as follows.
User manager screen
User level Level
User Names default setting
1 User Level 1 Service level Services
2 User Level 2 Manager level Manager
3 User Level 3 User level User1

The operations with <operating possible item> レ in Authority settings screen


are possible.
For Authority setting screens, refer to 25.2 Authority settings.

User Level 3
User Level 2
User Level 1

Authority setting screen (default)

<Setting of User level>


Perform it in User manager screen. Log in the setting screen with user name
[Service] of User level 1. And set User Name and Password according to user's
operating policy.

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V1.4

⑫ Select Start button of PC and open [All applications].


⑬ Select [User Manager] of BiOLiS 30i.
⑭ [User Manager] Log in screen displays.
Input [Service] in “User Name” and select Log in button.
⑮ User manager screen displays.

User manager screen

⑯ Perform the settings, addition/change of user level, password and Auto Login,
according to user's operating policy.
If レ in Auto Login is set, automatically log in with the set conditions.
⑰ Click Save button to save the settings.
⑱ Select Close button to close User manager screen.

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Setup Manual

29. Shutdown

End the analyzer and PC.

② ③ ①
⑤(Pop up display)
System program ending


Main screen

Step Operation button and screen Operation and movement

Icon Select the icon.


1 ①
(System power) The analyzer system power is off.

2 ② Confirm that the sign is [OFF LINE].


3 ③ Confirm that the sign is [---].
4 ④ Select Exit button.
5 ⑤ ⑥ (PC screen) System program ending screen displays by pop up.
6 ⑥ System status monitor Select Exit button.

Temperature control
7 End “System program”.
status monitor

8 End Power off PC.


Turn off Main power supply of the analyzer.
Main power switch is in the left of rear of the
analyzer.
If Analyzer system power is OFF and Main power
9 −
switch is ON,
- The analyzer cools reagent tray.
- In case of with electrolyte (ISE) unit,
automatically sends Calibrator 1 every 2 hours.

83
Setup Manual, Ver1.4
Published: Aug. 15, 2018
Printed in Japan

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