Ver.1.

04CE

Simple Operation Manual

Manual
SET UP
(1) Check the level of buffer, purified water and wash solution
※ Left: Buffer Center: Wash solution Right: Purified water
※ Change buffer or refill them (W.S. and P.W.) if needed.
※ See P.6 for how to set W.S. and P.W.
(2) Check the drain tank is not full
※ Empty the tank if needed.
(3) Remove the ‘DISPO-
DISPO-10’
10’ and Sample rack if needed.
(4) Check the thermo-
thermo-sensitive paper (Printer paper)
※ Set the paper if needed.
(5)
(5) Turn on the system
system power switch (on the left side).
※ After initialize and heat-up, “SAMPLE” screen in the “ANALYZE”
will be displayed.
SET
(1) Set ‘OC-
OC-Auto 3 Latex Reagent’
eagent’
1. Open the reagents cover. (Right side)
カバー開突起
Cover Jog
※ Press the reagent cover jog to open it.
2. Set Latex reagent on the reagent cradle.
※ Mix it three times gently. Open the cap and set the bottle.
(Make sure there are no bubbles)
bubbles)
3. Close the reagent cover.
(2) Set ‘DISPO-
DISPO-10’10’ (Cell)
1. Open the cell cover. (Middle one)
※ Press the cell cover job to open it.
2. Set the cells from the right side.
※ Up to 2 cells can be set
※ See P.3Check / Edit analysis setting (4)Setting the start cell for
the details.
3. Close the cell cover.
(3) Set sampling bottles /sample cups
1. Set the sampling bottles from the hook side of sample rack.
＜Sampling bottles＞
bottles＞ Check the sampling bottle caps are Rack bar code label
completely closed. The barcode label side needs to face the left
with the green cap facing down.
＜Sample cups＞
cups＞ Dead volume is 100uL. Pour at least
hook
150uL of sample.
※ Rack barcode and sampling bottles barcode need to face the
same direction.(Left ) 1 2 3 4 5
※ Racks can hold sampling bottles and sample cups in any order.
※ 5 sampling bottles or sample cups can be loaded on 1 rack.
(4) Load sample racks on the sample rack cradle.
1. Open the sample cover. (Left)
※ Press the sample cover jog to open it.
2. Load the sample rack from the right side of the sample rack
cradle with the hook facing the back side.
※4 sample racks (20 samples) can set in the sample rack cradle.
3. Close the sample cover.
-1-
 Ver.1.04CE

ANALYZE
(1) Start
Start analysis
1. Check the analysis setting is correct.
※See P.3Check / Edit analysis setting for details.
2. Check the racks and cells on the screen
※After pressing START, the remaining latex quantity will be
displayed.
3. Press [START] on the screen

Analysis will start.

Display of sample rack status

No rack ：Box
Box only
Unanalyzed sample rack ：Gray
Gray
Sample under sampling ：Light
Light Blue
Sample without sample liquid ：Red
Red
Sample being sampled ：Blue
Blue + White
No sample ：Black
Black
Sample error ：Red
Red

Display of cell status

No cell ：Box
Box only
Unused cell ：Gray
Gray
Sample Under dispensing ：Light
Light Blue
Reagent being dispensed ：Pink
Pink
Cell used for analysis ：Blue
Blue

Display of Latex volume

Full reagents:
All 4-
4-level scales are displayed in Blue
Small quantity is Low Reagent:
The lower scales are displayed in red

4. Result will be printed after the analysis.

OC-io 2011.02.24 Current Date

**************** Calibration Curve No.
CC No. 1
SEQ No. (001-999)
001 001-01
AEHF9Z Sample Bar code No.
- 0ng/mL
Sample Rack No.
002 001-02 Position No. in the rack
AEHG9F
Concentration
+ 258ng/mL
Flag (-/+)
003 001-03
AEHN8E
+OR2223ng/mL
Over Range (1001 over)
004 001-04
READ ERR
- 89ng/mL Error Code

-2-
 Ver.1.04CE
Check / Edit the analysis setting
(1) Mode setting
Press [MODE] tab to display mode selection.
AUTO ：When analyze automatically (routines)
MANUAL ：When analyze cells dispensed manually.
RETEST ：When re-analyze the sample once punctured.

※ Retest mode will not puncture sampling bottle again.

(To prevent contamination)
contamination)
※After the analysis, change the [MODE] back to [AUTO].
(2)Setting the Calibration curve number
Press [CC] tab and select Calibration curve number
※ 3 Calibration curves will be displayed.
※ Created Date and Lot No will be displayed on the screen.
※ See P5 Calibration curve creation for the details.
(3)Setting
(3)Setting the sample number
Press [SEQ#] tab
Number input dialog will be displayed.
Input number and press [Enter]
※ You can set sample No. from 1～999
※ When turn on the system switch, the SEQ # will become 1.
(4)Setting
(4)Setting the start cell number
Press [START CELL #] tab
Number Input dialog will be displayed.
Input number and press [Enter]
※ You can set cell No. from 1～20
※ When all cells are used, [NONE]
※ When turn on the system switch, the Start cell # 【BS】 :The last one input will be deleted
will become 1. 【Clear】 :All input will be deleted
【Enter】:Fix the input figures
※ When using half used cell, need to change this
number.
※ To re-enter the start cell number, cell needs to be loaded
again.

Closing process
(1) Remove reagent, cells
cells and racks
※ As soon as analysis is completed, close the latex reagent cap
and put it back in a fridge.
※ If sample racks and cells are still in the equipment, error
message will be displayed when restarted.
(2) Closing

Press [MENU]→[CLOSE]→[START]
※ [MENU] button will be upper right of the screen.
(3) Turn off the system power switch (on the left side)
※ Do not turn off the main power switch on the back.
※ If the equipment will not be used more than 1 week, read
Operation manual.
(4) Check the level of Buffer
※ Replace it to new bottle if needed.
(5) Empty the drain tank

-3-
 Ver.1.04CE
Quality Control
(1) Set controls
1. Add OC-Control LV1 & LV2 into the sample cups.
※ 200μL(at least 4 drops)
※ Do not make bubbles.
2. Set OC-Control LV1 cup at the position 1. (hook side)
3. Set OC-Control LV2 cup at the position 2.
4. Load the control racks to the rack cradle.
※ The hook side facing the back side.
(2) Run controls
controls LV1 LV2
1. Press [QC] tab
※ The measuring control screen will be displayed.
hook
2. Select control to measure.
※ Select either “Yes” or “No” for each control to run/not run.
3. Press [START]
1 2 3 4 5
※ Start measurement of controls
4. Result will be printed and go back to [ANALYZE] screen.

-4-
 Ver.1.04CE
Calibration curve creation CC Rack
(1) Dispe
Dispennse ‘Diluent’
Diluent’ to a sample cup
※ Dispense about 2mL ① Diluent (about 2mL)
(2) 12 drops of the Calibrator in a sample cup Diluent ② Calibrator (12 drops)
※ Do not make bubbles. (2mL) ③
(3) Set cups on the rack ④ 3 Empty cups
1. Set Diluent cup, Calibrator cup and Empty Cups like ⑤
picture on the right.
2. If control will be measured at the same time, set control
cups like the picture on the right. QC Rack
(4) Load the Racks
※ First, set the CC Rack on the right and QC rack next to it. ⑥ Control LV1 (4 drops)
(5) Set new ‘DISPO-
DISPO-10’
10’ ⑦ Control LV2 (4
(4 drops)
1. Set the DISPO-10 on the right side. ⑧
※It needs to be new ‘DISPO-10’(cell) ⑨ None
(6) Calibration curve creation ⑩
1. Press [CC] tab
※ The calibration curve creation screen will be displayed.
2. Select calibration curve number
※ You can set calibration No. 1, 2, or 3 for the calibration curve
creation.
3. Select with / without Controls
※ For QC-Low(LV1) / QC-High(LV2), select either “Yes” or
“No”
4. Enter Latex Reagent Lot No.
5. Press [START]
※ Calibration curve creation will start. OC-io 2011.02.04
6. Result will be printed like the picture on the right. ****************
(7) Check and set of Calibration curve and control data CC DATA
1. Check the printed data. ****************
Upper conc. : Theoretical value (Concentration of the Calibrator) LotNo.12001
CC No. 1
Lower conc. : Application value (The concentration recalculated
STD NUMBER =5
based on OS value using specified calibration curve STD OS
formula) 1 0ng/mL 0
OS value : Electrical value of the optical system (0ng/mL)
2 50ng/mL 38
Judgment (49ng/mL)
STD2 Lower conc. should be ±10% difference from the upper conc. 3 200ng/mL 216
STD3~5 Lower conc. should be ±5% difference from the upper conc. (200ng/mL)
4 500ng/mL 715
2. If everything is ok, press [Yes] to memorize the data.
(499ng/mL)
(8) Check the control result 5 1000ng/mL 1510
Check the control result is within the acceptable range. (1000ng/mL)
(See the package inserts)
CONTROL1
135ng/mL
CONTROL
433ng/mL

CC TYPE =2
CC DEGREE =3
CC FORMULA
F(0)= 1.1406e+01
F(1)= 1.0002e+00
F(2)=-6.3780e-04
F(3)= 2.7089e-07
PRC =553
-5-
 Ver.1.04CE

NOTE

Adding samples during analysis

While cover open/close indicator (Blue (Blue LED light)
light) is off, add
sampling bottles,
bottles, cells, or latex reagent, if needed.
※ cannot add another sample rack during sampling
※ cannot add another cell during latex being dispensed
※ cannot change another latex reagent bottle during reagent
being dispensed
※ When there are not enough cells during analysis, the message Blue LED light
will be displayed. Select [CONTINUE] or [STOP]
[CONTINUE]: add new cells or replace cells and press ANALYZE SAMPLE
[CONTINUE] 11

[STOP]: analysis will be ended and go back to [ANALYZE] MESSAGE (102)

screen. There is an unknown sample. Please install

new cells and press CONTINUE. To stop
※ If cell is removed and press [STOP], error message will be analysis, please press STOP.20
1

displayed CONTINUE STOP

Setting the number of replicates

10
STOP
(1) Input number of replicates for sample
[MENU]→[SETTINGS]→[REPLICATE # (SAMPLE)] MENU 2011.02.18 09:00

※ Set the number of samplings from the same sample cup.

(2) Input number of replicates for QC
[MENU]→[Settings]→[REPRICATE # (QC)] ANALYZE PRIME PROCESS DATA

※ Set the number of samplings from the same control cup.

Setting the cut off value
MAINTENANCE SETTINGS STOP

I
nput cut off value
[MENU]→[SETTINGS]→[CUT OFF VALUE]
※ Result below the cut off value will be negative(－)
Ex) if cut off value was set 100ng/mL
0～100ng/mL is negative(－), 101ng/mL or above is positive(＋)

Replacement of Buffer/Wash Solution/Purified Water

(1)
(1) Remove the empty bottle. Insert the tube into the new bottle
and plug it.
MENU
※ Be careful not to spill liquid on the equipment. 2011.02.18 09:01

(2) Prime processing

[MENU]→[PRIME]→(select)→[START] Please choose process method.
※ Select the replaced bottle and press [START]. ANALYZE
ALL P.W. PRIME
W.S. PROCESS DATA
BUFFER

※ Prime will fill tubes with solution and push out the air in the CANCEL START
tubes.
Prepare ‘Wash solution’ MAINTENANCE SETTINGS STOP

Make about 3% original of Sodium Hypochlorite

Hypochlorite solution by
purified water.
 Sodium Hypochlorite solution: 15mL
 Purified water: about 485mL

-6-
 Ver.1.04CE
PREPARATION OF REAGENTS
1. OC-Auto3 Latex Reagent (V-PH18)
Take the reagent bottle out of refrigerator and bring to room temperature.
Gently invert several times to assure uniform suspension.

After opening, reagent stability:

• In refrigerator (2-10° C), stable for 14 days.
• Stored onboard for 7 days (Latex reagent cap needs to be closed when not testing)
Do not mix reagent with another bottle.

2. OC-Auto3 Buffer (V-PH46)

Incubate for 30 min in the buffer bottle cradle before use.

After opening, buffer stability:

• Stored ‘onboard’ for 1 month
• In refrigerator (2-10° C), buffer will be stable for 2 months.
Do not mix buffer with another lot.
Do not pour more buffer solution into the bottle.
Do not use precipitated buffer, precipitant of the buffer may cause the troubles.

3. OC-Calibrator 2 Kit (V-PH52)

OC-Calibrator 2 Kit is supplied ready to use. Calibrator should be stored at 2-8°C and is
stable until the expiry date, even when opened.

OC-SENSOR io stores up to 3 calibration curves in the memory. The calibration curve is

stable without time limitations and only requires changing under the following conditions:
• When the lot of latex reagent is changed.
• When the value of OC-Control (LV1, LV2) doesn’t come up to the indicated range.
• When opened latex reagent bottle is stored at 2-10°C for over 2 weeks or is stored in
the reagent bottle cradle for over 7 days.
• Following some maintenance support procedures

4. OC-Control LV1 & LV2. (V-PH53, V-PH54)

OC-Control LV1 & LV2 are supplied ready to use. Controls should be stored at 2-8°C and is
stable until the expiry date, even when opened.

Minimum requirements are to analyse the both controls before analysis on a daily basis.

5. Preparation of the wash solution.

Make 0,15% NaClO of the 3% stock solution with deionised water (15 mL + 485 mL).

6. Preparation of the purified water.

Refresh the purified water every day.

-7-