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Automated Clinical Analyzer

Reagent Barcode Manual

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
Reagent Barcode Manual

Index

1. Reagent barcode system information ..................................................................... 2


1.1 Difference between the [Open] and [Close] setting. ........................................... 2
1.2 [Prohibition of identical barcode] setting. .......................................................... 2
1.3 [Prohibition of Fill button] setting ..................................................................... 2
1.4 Difference of reagent remain update between reagent barcode settings. .......... 3
1.5 Reagent bottle transfer ...................................................................................... 4
1.6 Display of expired reagent. ................................................................................ 4
1.7 Display and input of [Reagent info. screen] ....................................................... 5
2. Reagent barcode setting procedure ........................................................................ 6
2.1 Barcode kind setting. ......................................................................................... 6
2.2 Program login level for [Reagent barcode registration] and [Modification] ....... 9
2.3 Reagent barcode setting. ................................................................................. 10
2.4 Reagent barcode registration........................................................................... 11
2.4.-(1) “Open” or “Close” setting............................................................................ 12
2.4.-(2) Reagent maker registration ....................................................................... 13
2.4.-(3) Input barcode format ................................................................................. 14
2.4.-(4) Bottle code and system Item number setting............................................. 16
2.4.-(5) Save button ................................................................................................ 17
3. Barcode label creation .......................................................................................... 18
3.1 Barcode type. ................................................................................................... 18
3.2 Barcode label information. .............................................................................. 18
3.3 Barcode label position...................................................................................... 19
3.4 Example of reagent barcode. ........................................................................... 20
4. Bottle setting with reagent barcode. .................................................................... 21
4.1 Reagent bottle setting procedure. .................................................................... 21
4.2 Barcode read error and error screen. ............................................................... 23
5. Reagent remain (test count) calculation............................................................... 24
5.1 Reagent remain calculation by [Level sensor] ................................................. 24
5.2 Reagant remain calculation by [Count] ........................................................... 24

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V1.0

1. Reagent barcode system information

How to use the reagent barcode system?


The function of reagent barcode is used for reagent bottle setting by barcode reading
on the bottle.
There are two reagent barcode settings of “Open” and “Close”. Select “Open” or
“Close” by the user.

1.1 Difference between the [Open] and [Close] settings.

Allows [Reagent barcode reading] and [Manual] settings of the


Open
reagent bottle in reagent screen.

Allows setting of the reagent bottle by [Reagent barcode


Close reading]. Doesn’t allow manual setting in reagent screen.
Dilution and detergent bottle settings can be set manually.

1.2 [Prohibition of identical barcode] setting.


Select “On” or “Off” for update the reagent remain after reading the identical
reagent barcode automatically.
In case of the [Prohibition of identical barcode] is “On”.
・The reagent remain is not update after reread the identical reagent
barcode automatically.

1.3 [Prohibition of Fill button] setting


When [Close] is selected, the “Fill” selection is added. Manual update of reagent
remain is selected On or Off.
In case of the [Prohibition of Fill button] is “On”.
・ [Fill] and [Fill All] buttons are invalidation. The reagent remain can’t
update manually.

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Reagent Barcode Manual

1.4 Difference of reaegnt remain update between the “Open” and “Close” settings.

Summary of reagent remain update by [Open] and [Close], [Prohibition of identical


barcode] and [Prohibition of Fill button].

[Open] setting
Prohibition of identical barcode

On Off
Possible. Possible.
Reagent remain is not Reagent remain is not
updated automatically updated automatically after
Rereading of after rereading the rereading the barcode.
identical barcode barcode. In case of [Count] setting,
the reagent remain is
updated automatically.
Reagent remain
The reagent remain is updated by clicking of [Fill] or [Fill All]
update
button.
(Fill、Fill All)

[Close] setting
Prohibition of identical barcode
On Off
Prohibition of [Fill] button
On Off On Off
Possible Possible
When rereading the When rereading the barcode,
Rereading of barcode, the reagent the reagent remain is not
identical remain is not updated updated automatically.
barcode automatically. In case of [Count] setting,
the reagent remain is
updated automatically.

Reagent remain Update by


Update by [Fill] or
update Not updated [Fill] or [Fill Not updated
[Fill All] button.
(Fill、Fill All) All] button.

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V1.0

1.5 Reagent bottle transfer

Function of reagent bottle transfer?


The multiple bottles of same Item are able to use. If a residual test reaches to less
than stop setting, the analyzer transfer to next bottle automatically.
The transfer sequence follows the priority number (set sequence).

① In case of [Reagent barcode] and [Manual settings.


When R1 or R2 using up the first bottle, the analyzer aspirate from the
second bottle both R1 and R2.

When the R2 using up first, the analyzer transfers as follows.

・ The reagent remain setting is [Level sensor].


The residual test is checked by reagent probe up and down.
The R2 residual test is checked after R1 aspiration.
Then R2 short reagent error will occur when R2 residual test is
less than stop level after R1 dispensation

・ The reagent remain setting is [Count]


Reagent test count is checked when analyzer program starts the
measurement. The R1 transfer to second bottle before R2 is less
than stop level. The short reagent error is not occurred.

The expired reagent is not used. Move to next bottle.

② In case of [Reagent barcode] setting.


No transfer to different lot number bottle.
Please perform the calibration after the analyzer stop. Rerun is
necessary.

1.6 Display of expired reagent.


Each screen display
Reagent screen:The back color turns to green when expired the date.
The priority column changes to “0”.

Order screen
Calibration screen The bottle Item name is not displayed
QC screen-QC order screen in these screens.

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Reagent Barcode Manual

1.7 Display and input of [Reagent info. ]screen

The [Reagent info. screen] is displayed depending on the setting by [Reagent


barcode] or [Manual] settings.

Reagent - Reagent info. screen

[Reagent info. screen] =Automatic display, ×=No automatic display


In case of [Reagent barcode] setting In case of [Manual] setting

Item number
Item name
Reagent kind

In case of [Count] setting.

Display by reagent barcode


R1 ,R2 Display by [Fill] setting
information or set [Fill]
(Display test count) manually.
manually.
*Depending on
the setting. In case of [Level sensor] setting.

Display by liquid level sensor Display by liquid level


within run. sensor within run.
Display by reagent barcode
Expire date ×
information.
*When set it. (Manual input is possible)
(Manual input is possible)
Expire date Display by reagent barcode
×
(After open) information.
(Manual input is possible)
*When set it. (Manual input is possible)
Lot number Display by reagent barcode
×
*When set it. information.

Priority

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V1.0

2. Reagent barcode setting procedure

The reagent barcode setting is necessary before using the reagent barcode.

Note: The reagent barcode setting is available by possible operator level.


Please login by applicable level.
Default setting: [User Level 1], User Name [Service], No Password

Reagent barcode setting flow

1) Select the using barcode kind.


* Login by [Service] when default setting.
2) [System]-[System parameter]-[Reagent barcode]: Select “ON”.
3) [Tool]-[Barcode Reader Setting] : Set the reagent barcode information.

2.1 Barcode kind setting.

The barcode kind is set by [Barcode Reader Setting ] in tool screen.

③↓

②→
①→

Step Button & Screen Operation & Display


1 ― Close the system program.
2 ① PC start button Click start button.
3 ② All application Select [All application]
4 ― Tool list of BiOLiS 30i file is shown.
Barcode Reader
5 ③ Select [Barcode Reader Setting].
Setting

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Reagent Barcode Manual

Step Button & Screen Operation & Display


6 ― Barcode Reader Setting screen is shown.
Barcode Reader Setting
7 Set the barcode information.
screen

↓①
←⑦

←③


←④

↑⑤ ↑⑥

Code1 ( - Code 4)
Barcode Reader Setting screen

Step Button & Screen Operation & Display

① Reagent barcode Select reagent barcode.


Set the using barcode.
② Code1 - Code4 Barcode is able to set for each Code1 - Code4.
Setting procedure is common for Code1 - Code 4.
[Code1 - Code4] setting.
CODE39
ITF
2of5
Select barcode kind.
③ NW-7 (Codabar)
[ITF] code is recommended.
JAN/EAN/UPC
CODE128
8 COOP2of5
Popup the “ Code length” screen
④ Edit Set the code length.
No display when selected JAN/EAN/UPC.
Popup the “Barcode detail setup “screen.
Set the barcode information.
⑤ Detail Display different screen by barcode kind.
When [2of5] or [COOP2of5] is selected, the
button is invalid the operation.
Popup the “Option set” screen.
⑥ Options
Set the option.
⑦ Save Register the setting.

9 ― Restart the system program.

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V1.0

Barcode detail setup screen


①CODE39 ②ITF

③NW-7(Codabar) ④JAN/EAN/UPC

⑤CODE128

Option setup screen

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Reagent Barcode Manual

2.2 Program login level for [Reagent barcode registration] and [Modification] setting.
The reagent barcode setting is available by possible operator level.
Please login by applicable level.

Default setting.
[User Level 1], User Name [Service], No [Password]
Please refer to setup manual Chapter 25, 2 Authorization for analyzer
operation setting and Chapter 25.3 Setting of user level and password.

In case of default setting, login by user name [Service].

←④

←⑤

Login screen
①→ ②↓

Step Button & Screen Operation & Display


1 ① System Click system button.
2 ② Log off Select logoff button.
3 ③ ― Pop-up “Login” screen.
Input user name.
Input user name which is applicable level to set the reagent
4 ④ User name
barcode.
Input [Service] for default setting.
Click “Login” button.
5 ⑤ Login
The reagent barcode setting is possible.

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V1.0

2.3 Reagent barcode setting.

②↓

①→

⑤→

④↓ ⑥↓

System parameter setting screen

Step Button & Screen Operation & Display


1 ① System Click “System” button.
System parameter
2 ② Select “System parameter” setting.
setting
3 ③ ― System parameter setting screen is shown.
Select “Reagent barcode” setting.
Select the reagent
4 ④ The user level is not correct if the button can’t
barcode
operate.
5 ⑤ Setting Select “On”.

6 ⑥ Save Click “Save” button, and register the setting.

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Reagent Barcode Manual

2.4 Reagent barcode registration

②↓

①→

←④←④

Reagent barcode setting screen

Step Button & Screen Operation & Display


1 ① System Click “System” button.
Select reagent barcode.
2 ② Reagent barcode
Login level is not correct if the button can’t operate.

Reagent barcode setting screen is shown.


3 ③ ― *Set the details of reagent barcode information.
Refer to next pages 2.4-(1) - (5).

4 ④ Save Click “Save” button, and register the settings.

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V1.0

Reagent barcode registration is follow the next 2.4 –(1) - (5).


Note: Do not move to other screen before clicking [Save] button.
The setting will be canceled.

2.4.-(1) “Open” or “Close” setting.


(1)↓
←(5)
(3)↓
←(4)

(2)↑

Reagent barcode setting screen

(1) Reagent barcode setting

① Select “Open” or “Close”.


Allows [Reagent barcode reading] and [Manual] settings of the
Open
reagent bottle in reagent screen.

Allows setting of the reagent bottle by [Reagent barcode


Close
reading]. Doesn’t allow manual setting in reagent screen.

② Set the [Prohibition of identical barcode] (Check the box レ to On)


In case of “On”.
・ The reagent remain is not update automatically after reading the
identical barcode.

When “Close” is selected, need to set additional setting as follows.

③ Set the [Prohibition of fill button ](Check the box レ to On)


In case of “On”.
・ Unable to operate the [Fill] and [Fill All] buttons. Reagent remain
can’t update manually.

*Please refer to Chapter 1, 4 Difference of reagent remain update between


reagent barcode settings.

④ Please step to 2.4 – (2) Reagent maker registration.

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Reagent Barcode Manual

2.4.-(2) Reagent maker registration

(1)↓
←(5)
(3)↓
←(4)

(2)↑

Reagent barcode setting screen

(2) Input reagent maker code and name.

① Set [Maker code] and [Maker name].

Maker code 20 kinds of maker are able to set by 1 - 5 digits code.

Maker name Maker name is able to set Max 16 digits.

② Click button in maker list, and open reagent maker list screen.

③ Select maker code number from 01 to 20.


④ Input maker code and name.

Input example

⑤ Please step to 2.4 – (3) Input barcode format.

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V1.0

2.4.-(3) Input barcode format.

(1)↓
←(5)
(3)↓
←(4)

(2)↑

Reagent barcode setting screen

(3) Barcode format setting.


Input the reagent barcode format.
Need to set for each reagent maker.

① Click button in maker list, and open maker list screen.


② Select maker name for barcode format setting.

③ Input start digit and number of digit.


Start digit :Start digit of barcode character.
Digit number :Number of digit

Please refer to digit number for each Item in next page.

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Reagent Barcode Manual

Barcode format
Item Contents Digit Input
Maker code number
1 Maker code Display maker code which registered in 1-5 Necessary
maker code column.
Set a peculiar number for each Item on the
2 Item code 1-5 Necessary
system.
Reagent bottle kind
3 Bottle kind 1 Necessary
1 = Single 2 = Double
Expire date Last digit of YYYY
4 1 Option
(Year) (Past 2 years and future 7 years )
The 1st week of the beginning in January which
Expire date is together with all of seven days from Monday to
5 2 Option
(Week) Sunday is counted as 1.
0 -52 weeks.
Expire date
6 Count starts after bottle setting. 2 Option
(After open)

Select kind of bottle size from 1, 3, 4 and 6.


1 24 Item Single reagent 60ml
7 Bottle size 3 24 Item Double reagents 40ml/20ml 1 Necessary
4 36 Item Single reagent 40ml
6 36 Item Double reagents 25ml/13ml

8 Lot number Reagent Lot No. 1-5 Option

9 Bottle code Individual bottle discrimination No. (1) 1-5 Option

10 Bottle number Individual bottle discrimination No. (2) 1-4 Option

Note: Maximum setting digit is 24 digits.


・ For above necessary Items (Maker code, Bottle Item code, Bottle kind,
and Bottle size), need to set the stating digit and digit number.
・ Input “0” for unused Item of start digit and digit number.

④ Please step to 2.4 – (4) Bottle and system Item number setting.

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V1.0

2.4.-(4) Bottle code and system Item number setting.


(1)↓
←(5)
(3)↓
←(4)

(2)↑

Reagent barcode setting screen

(4) Setting of bottle Item code from the Item number on the system.
The Item number on the system corresponds to bottle Item code.
The bottle Item code setting is necessary for each reagent maker
individually.

① Click button, and open reagent maker list.


② Select the reagent maker.

③ Input [Bottle Item code] and [Item number] on the list.


Item code : Input bottle Item code which registered in reagent barcode.
Item number: Input Item number on the system.
Note: Do not move to other screen before clicking [Save]
button. The setting will be canceled.

Example: Optical Item ・Item number

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Reagent Barcode Manual

Item number list


Item number Item
1 - 77 Optical Item
101、102、106 HbA1c

Item number Item Contents


Serum
96 L-H-I
information
Lysing
99 Lysing
Other solution
111 DIL 1 Diluent
*Item name
112 DIL 2 Diluent
can’t change.
113 Wash 1 Detergent
114 Wash 2 Detergent
115 Wash 3 Detergent

Note: The serum information, detergent, dilution and lysing bottles can
set manually (without barcode) when the barcode setting is “Close”.

④ Please step to 2.4 – (5) Save button.

2.4.-(5) Save button.

(1)↓
←(5)
(3)↓
←(4)

(2)↑

Reagent barcode setting screen

(5) Register the settings.


① Confirm the settings after input.
② Click “Save” button, and register the settings.

The reagent barcode registration is completed.

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V1.0

3. Barcode label creation

3.1 Barcode type

The barcode reader can scan the following type of code.


The ITF code is recommended.
Barcode kind
1 ITF
2 CODE39
3 INDUSTRIAL 2 of 5
4 NW-7(Codabar)
5 JAN/EAN/UPC
6 CODE128
7 COOP 2 of 5

3.2 Barcode label information.

① Need to follow the setting of barcode format.


② Maximum digit number of reagent barcode is 24 digits.
③ The barcode length should be less than 50mm.
④ Need enough quiet zone that more than 10 times (5mm) of thin bar in barcode
read window on the reagent tray.
The quiet zone means that both white areas of barcode symbol.
The analyzer can’t read the barcode which quiet zones are not enough.

(Less than 50mm)

Thin bar
(Narrow bar)

Example :<ITF code> <Barcode symbol extension>


Barcode read window
on the reagent tray.

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Reagent Barcode Manual

3.3 Barcode label position

When reagent bottle is set on the reagent tray, the scan side is outside.

Scan side
Scan side

Single reagent bottle Double reagent bottle


Regent 2

Example:
Upper limit: 3mm

Lower limit: 2mm

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V1.0

3.4 Example of reagent barcode.

In case of the below settings, the barcode is created as follows.


Start Digit Example
Item Contents
digit No. code
1 Maker code 1 3 001 TMS
Bottle Item: Set Item number
2 Item code 4 2 01
on the system.
3 Bottle kind 6 1 1 Single reagent
Expire date
4 8 1 8 Last digit of 2018.
(Year)
Expire date
5 9 2 45 45 weeks
(Week)
Expire date
6 0 0 Unused
(After open)
7 Bottle size 7 1 1 24 Items single, 60mL bottle
8 Lot number 11 3 123 Lot number.
Individual bottle discrimination
9 Bottle code 14 4 0001
code
10 Bottle number 0 0 Unused

Example:

<ITF code>
Quiet zone: Need more than 5mm of
space both upper and
lower parts.
Need more than 10 times
of thin bar
Less than 50mm

Barcode read window


on the regent tray.

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Reagent Barcode Manual

4. Bottle setting with reagent barcode.

4.1 Reagent bottle setting procedure.

←②

←① ④


Reagent screen-Reagent setting screen


↑ ↓
⑥→
Read position appointment screen

Step Button & Screen Operation & Display

1 ① Reagent Click “Reagent” button.


2 (PC screen) Reagent screen is shown.
3 ② Reagent setting Click “Reagent setting” button.
4 (PC screen) Reagent setting screen is shown.
Round name: Select reagent round.
5 ③
(Round name) Select bottle setting round.
6 ④ (1~36) Confirm the setting bottle position.
7 ― Set the reagent bottle with reagent barcode.
8 ⑤ Barcode reading Click “Barcode read” button.
Pop-up screen
9 (PC screen) Position appointment screen is shown.

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V1.0

Step Button & Screen Operation & Display


(In case of individual reading)
Select the bottle position button which read the barcode.
10 ⑥ (1 - 36) or All
(In case of all reading)
Select all selection.
11 ⑦ OK Click “OK” button.
12 ― Start the reagent barcode reading.

← ②




Reagent― Reagent info. screen

Step Button & Screen Operation & Display


Complete the reagent barcode reading.
*Popup the error screen when read error occurred.
13 ―
Click [OK] button after confirming the reagent tray
position and error information.
14 ⑧ Reagent info. Select regent info. button.
15 (PC screen) Reagent info. screen is shown.
16 ⑨ (PC screen) Display the reagent information by read reagent barcode.
*In case of prohibition of [Fill] button is On, the reagent
remain can’t update.
Reagent remain update:
Update the reagent remain by measurement condition
Fill automatically.
17 ⑩
Fill All Fill=Selected Item update the reagent remain.
・Select Item and click Fill .
Fill All=Update all the Item of reagent remain.
Update the reagent remain by reagent probe up down
when the setting is level sensor.
18 ⑪ Save Register the reagent bottle setting (Reagent remain).

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Reagent Barcode Manual

4.2 Barcode read error and error screen.

When barcode read error occurred, popup the barcode error screen.

1) Reason of the reagent barcode read error.


・No barcode bottle is read.
・The barcode setting is not correct.

2) Barcode error screen.

Example: Barcode read error

Screen information
Operation & Display
Pos. Position number of the reagent tray.
Display of barcode information.
Barcode [ERROR] will display after reading the no barcode
bottle.
OK Close the barcode error list screen.

3) Confirm the following parts when read error occurred.


・Barcode position on the reagent bottle.
・Barcode setting on the system.
Refer to 2. Reagent barcode setting procedure.
・Reagent barcode itself which made correctly.
Refer to 3. Barcode label creation.

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V1.0

5. Reagent remain (test count) calculation

Reagent remain is displayed by level sensor or test count individually.


5.1 Reagent remain calculation by [Level sensor].
Display by calculation of bottle kind and reagent level sensor.

5.2 Reagant remain calculation by [Count].


There are two kind s of reagent remain display.
① Display by reagent barcode information.
② Calculates by following formula when manual setting of “Fill” or
“Fill All” is selected.

Remain test number=([Reagent volume]-[dead volume])/[One time aspiration1]


Bottle volume=in Item screen・Bottle(mL) volume
Bottle dead volume= Refer below list
One time aspiration=in Item screen・Dispensation (μL) volume +
Add volume (10μL)

Reagent bottle dead volume


Bottle kind Dead volume
Single reagent 40 mL 2.5 mL
36 Item bottle 25 mL 1.5 mL
Double reagents
13 mL 1.0 mL
Single reagent 60 mL 2.0 mL
24 Item bottle 40 mL 1.0 mL
Double reagents
20 mL 0.8 mL

Example: Reagent remain(Test count)= (35000-2500)/150 = 216 (Test)

Bottle kind=36 Item bottle


Reagent volume=35 (mL)
Dead volume=2.5 (mL)
One time aspiration volume=140 (μL)+10 (μL)

Dispensation (μL)
Bottle volume (mL)

Item screen

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Reagent Barcode Manual, Ver1.0
Published: Sep.13, 2016
Printed in Japan

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