User Manual for STANDARD F2400 Analyzer

Medical Device

Manufacturer :
Manufacturing Site: 74, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu,
Cheongju-si, Chungcheongbuk-do
+82-31-300-0400 +82-31-300-0499 [email protected] www.sdbiosensor.com
Thank you for purchasing the STANDARD F2400 Analyzer.

This User manual contains all information about the Analyzer. Pease read this User
manual carefully and familiarize yourself with the required preparations and test
procedure before performing a first test.
Please read the instructions carefully which are included in each test device
package before using the Analyzer.

If you have any questions about the analyzer, please contact your local distributor.
You can also visit www.sdbiosensor.com for product demonstrations.

Again, thank you for purchasing the STANDARD F2400 Analyzer.

TABLE OF CONTENTS

Chapter 01. General Information .......................................................................................6

Main Menu Structure........................................................................................................6
Symbols and Abbreviation..............................................................................................8

Chapter 02. Overview.......................................................................................................... 12

Intended Use.................................................................................................................... 12
Product Overview........................................................................................................... 12
Precautions before perform a test........................................................................... 13
Specifications................................................................................................................... 15
Appearance of STANDARD F2400 Analyzer............................................................. 16
Accessories of the STANDARD F2400 Analyzer..................................................... 18

Chapter 03. Log On and Setting........................................................................................ 19

Operation of Analyzer................................................................................................... 19

Chapter 04. Work Place...................................................................................................... 30

Performing a test & Review........................................................................................ 30

Chapter 05. Calibration........................................................................................................ 38

Calibration Set Test........................................................................................................ 38

Chapter 06. Quality Control................................................................................................ 43

Quality Control Test........................................................................................................ 43

4
Chapter 07. Cleaning & Maintenance.............................................................................. 52
Cleaning of Analyzer..................................................................................................... 52
Maintenance & Transportation................................................................................... 52

Chapter 08. Messages & Troubleshooting...................................................................... 53

Warning Messages......................................................................................................... 53
Error Messages................................................................................................................ 54

ANNEX 01. Information for Professional Medical Personnel.................................... 57

Protection from Infection............................................................................................ 57
Electromagnetic compatibility................................................................................... 57
Disposal.............................................................................................................................. 57

5
Chapter 01. General Information
Log On
Main Menu Structure

Work Place Calibration QC

QC
Run Test Result Run Calibration Res
Run QC
Test Status Review Calibration Review Revi

Start Prepare
(Input CAL
Operator ID) QC with
Device External
Control
QC
solution
Insert
Insert
Device
Device
CAL-1 Input Insert
Control ID Device

Device Device
Checking Checking
Insert Device
Device Checking
Insert
Apply
Device
Sample Select
CAL-2 Device
Control
Checking
Information
Sample Device
Checking Checking
Apply Apply
Sample Sample
Insert
Mounting Device
CAL-3 Sample Sample
Checking Checking

Device
Checking
Mounting Mounting

Analyzing

Result

6
 QC Utility

QC
Result Monthly
System Maintenance Statistics Operator Network
Review review

Date Add Network

/Time
ernal
QC

Print Edit HIS/LIS

ert
vice

Language Delete
vice
cking

Update
ect
ntrol
mation
Brightness
/Volume
ply
mple

mple
cking

nting

7
Symbols and Abbreviation

The symbols and abbreviation presented below are indicated on the User
Manual, labels and external package.

Symbols
Symbols Description

Manufacturer

In vitro diagnostic medical device

Intended to use outside the body

Consult instructions for use

Reference Number

Date of Manufacture
To indicate the date of manufacture

Serial Number

Note

To indicates that the analyzer is fragile and you need to handle it

with care

Batch code
Indicate the lot number of the system

Crossed out wheeled bin

Discard it separately from other household waste

Fulfill the requirements of Directive 98/79/EC on in vitro diagnostic

medical devices

Indicate that you should keep the analyzer dry

Caution
Indicate a situation, which if not avoided could result in damage to
the device or incorrect results

8
Abbreviations
Abbreviation Description
Comm Communication
LIS Laboratory Information System
HIS Hospital Information System
GUI Graphic User Interface
S/W Software
F/W Firmware

9
Precautions

To reduce the risk of damage to Analyzer

·Use
· the Analyzer for in vitro diagnostics only.
Caution ·Keep
· the Analyzer in a flat and dry place. Avoid direct sunlight.
·Do
· not expose the analyzer to strong light. Otherwise,
serious interference to the test results may occur.
·Do
· not move the Analyzer during the test.
·Do
· not drop the Analyzer. Otherwise, the Analyzer may be
damaged.
·Do
· not attempt to disassemble the Analyzer.
·Do
· not immerse the Analyzer in water or cleaning solution.
To reduce the risk of inaccurate results
·This
· Analyzer should be used only by trained operators.
·If
· the error message occurs repeatedly, stop using the
Analyzer.
·For
· accurate results, refer to the manual that comes with
each test device.
·Do
· not use test devices which have expired.
To prevent electric shock
·Ensure
· the Analyzer is completely grounded. Do not connect
the Analyzer to an ungrounded outlet.
·When
· using a power board, use a grounded power board.
·Make
· sure that all cables are connected to the Analyzer
correctly and completely.
·There
· is a risk of electric shock if Analyzer is not grounded.
Use the power cable provided by the SD Biosensor. It
is recommended to use a power cable of 250V ~, 10A,
0.75mm2 (18 AWG).
·Do
· not share power supply with other instruments and/or
devices.

10
 To reduce the risk of biological hazards
·Discard
· the used specimens in accordance with federal, state
Biohazard! and local requirements.
·Treat
· specimens as potentially biohazardous material.
·If
· you have no experience with collection and handling of
specimens, appropriate education or guidance should be
received.
·Nitrile
· or latex gloves are recommended when handling
patient specimens.

11
Chapter 2. Overview
Intended Use
STANDARD F2400 Analyzer is an in vitro diagnostic medical device that measures
quantitative or qualitative biomarkers of body fluids such as blood, urine, nasal
discharge, etc., in a laboratory or POCT environment. The analyzer is indicated
for monitoring and diagnosing from the body fluid parameter in clinical settings
by healthcare professionals. In all cases, the Analyzer should be used with
designated test devices produced by SD Biosensor, Inc.
For details regarding to specific tests, refer to the user manual included with
each test device package.

Product overview
STANDARD F2400 Analyzer scans the 2D barcode of inserted test device. Based
on the scanned result of the inserted test device, the analyzer determines the
appropriate LED (UV, RGB) settings for the test device.
An antigen-antibody reaction takes a certain period of time after samples are
dispensed.
Once a reaction is completed, fluorescence dye on the control line and test line
will reflect the light from LED and this reflected value will be measured.
Then the measured value will be calculated based on the formula that is input
to the 2D barcode.

12
Precautions before perform a test

·Read
· and follow the instructions carefully in the user manual
and Instructions for use of the test device and control. It is
Note very important to follow the instructions in order to prevent an
inaccurate result or improper treatment.
·Be
· sure to check with your distributor and SD Biosensor for the
most up-to-date software and to update before use.
·Fatal
· consequences, such as fire or serious system damage,
may occur when the system is installed at an inappropriate
location, since the Analyzer cannot be replaced or removed
from power supply.
·The
· Analyzer must be installed in such a way that easy access
to power supply and power switch is ensured.

Specimens
The STANDARD F2400 Analyzer should be only used the specific test devices for
the analyzer. Because specimens are quite different for each parameter, follow
the instructions from the each test device instructions.

Safety Information
There is a potential risk of infection. Professional medical personnel should
always wear gloves when handling patient samples with the STANDARD F2400
Analyzer and test device. It is recommended that you follow all other locally
applicable health and safety regulations.

13
Operating Conditions
To operate the STANDARD F2400 Analyzer correctly, the following guidelines
should be observed :
·The
· operating conditions of the Analyzer are: 0℃-50℃ / 32℉-122℉, 10%-
93% RH.
·The
· operating temperature suitable for analyses differs in each test. For
each test, refer to the instruction manual of the test device that you will
use for analyses.
·To
· perform a test with the Analyzer, place the Analyzer on a flat surface.
·Do
· not use the Analyzer near strong electromagnetic radiation sources.
Otherwise, strong electromagnetic fields may affect the function of the
Analyzer adversely.
·If
· the Analyzer malfunctions suddenly, unplug the power cable from the
outlet.

It shall be lifted and carried by holding the bottom of an

instrument frame zones.
Note

14
Specification

Input Voltage AC 100~240V, 50/60Hz

Display 10.1” Color TFT LCD (1024 X 600)
Display Control Graphic User Interface
Power Consumption Up to 84W
Number of Memories 5,000 (Run Test)
Real Time Clock Including RTC Backup Battery
LIS / HIS HL7 PCD – 01 Profile Support
Dimension 510 X 566 X 297 mm
Inserts User Manual
Bar Code Scanner (Option) USB Barcode Scanner
Weight 20 kg

15
Appearance of STANDARD F2400 Analyzer

C
B

D
E

F
G
H

I
J
K

16
A. Color TFT LCD
Used for test screen display and interaction with graphical user interface

B. Inlet for insertion of test device

Used for insertion of test device into the Analyzer

C. Test device outlet

Used for discharge of test device that has completed the test

D. Printer cover
Used to cover and protect printer paper

E. Printer cover open button

Used to open printer cover

F. Mini USB
Used to upgrade firmware by connecting with PC

G. LAN
Used for communication using LAN Cable

H. AC power connection
Used for AC power cable connection

I. Power switch
Used to turn the Analyzer on/off

J. USB x 4
Used to connect the Analyzer to keyboard, barcode scanner and USB
memory

USB should be formatted as FAT32, so that the USB can be

Note recognized by STANDARD F2400 Analyzer.

K. Additional device connection part

Only use for connecting specific device that is produced by SD Biosensor, Inc

17
Accessories of the STANDARD F2400 Analyzer

CAL-1
CAL-2
STANDARD F
Calibration Set

CAL-3
Accessories

AC Power cable

STANDARD F
Test Device
(Example : HbA1c,
Influenza A/B)

Barcode scanner
Optional

Printer paper

18
Chapter 3. Log On and Setting
Operation of Analyzer
Step 1. Connecting the power cable
1-1. Place the Analyzer in a proper environment where it can be
plugged into outlet and barcode scanner (optional) can be
positioned together.
1-2. Connect the power cable to the power connector on the back of
the Analyzer and to the outlet.
1-3. Once the connection is complete, the analyzer is ready for use.

Step 2. Analyzer Log On

2-1. Press log on button.
2-2. The initial log on ID is admin and the password is 1111.

Step 3. Analyzer Setting

3-1. When the Analyzer is set up for the first time, user information
must be registered.
3-2. For initial setup, select the Utility screen on the main screen. The
details of the setting (Utility) menu are shown below.

Step Menu Submenu

Date/Time
Print
1 System Language
Update
Brightness/Volume
2 Operator Add, Edit, Delete
3 Network Network, HIS / LIS

Step 1: Log On Mode

1. Enter the Operator ID and password on the Log On screen and press the Log
On button. Operator ID is “admin” and password is “1111”.

19
Step 2: Setting Mode
1. Touch ‘Utility’ on the main menu screen to enter the setting mode.

2. Utility menu consists of submenus: System, Maintenance, Statistics,

Operator, and Network. System submenu can be used to set the Date/Time,
Language, Print, Brightness/Volume and proceed with the update.

① ④

② ③
⑤ ⑥ ⑦

⑧ ⑨

System Menu
1) Date/Time Setting
① Press an Up( ) or Down( ) button to change the year, month,
date, hour, and minute.
② The display type of year, month and date and be changed.
Change the date style setting.
- Year-Month-Day
- Month-Day-Year
- Day-Month-Year
③ Time unit is changeable between 12 hours (12h) and 24 hours (24h).

20
2) Print Setting
You can set the number of result sheet to 1 sheet or 2 sheets. Once press
“Auto Print”, the test result will be printed automatically after all.

3) Language Setting
Press a down arrow( ) to select the desired language from the drop-
down list.

4 ) Update
① S/W Update
Items needed for S/W update
·· STANDARD F2400 Analyzer
·· Software update file
·· USB(Not provided)
·· Personal computer(Not provided)
How to update the software
a. Prepare a USB memory containing the F2400's new software file.
ii. Format USB as FAT32 file system.
iii. Copy the software file to USB memory.
b. Connect the USB(that F2400 Software is copied) to the USB port on
the bottom left of the F2400 Analyzer.
c. If the USB is connected normally, “USB connected successfully” will
be displayed.

d. Press the S/W Update button. Then, “S/W Update?” will pop up.
Press “ OK “ to start the S/W update.

21
 e. If the S/W Update is completed, “S/W Update OK” will be displayed
on the screen. Press “OK” to reboot the analyzer.
`

f. Make sure that the latest S/W version is displayed in the lower left
corner of the screen.

② F/W Update
Items needed for F/W update
·· STANDARD F2400 Analyzer
·· Firmware update file
·· Mini-5pin USB cable
·· Personal computer(Not provided)
How to update the F/W
a. Connect your PC and device with a Mini USB cable. If the driver is
not recognized on PC, install the CP2101 driver.
b. Press FW update ( )on the screen.

22
c. Press “OK”.

d. Run the PC program.

e. When the Update Firmware button is enabled, click the button.

f. Click“Update Firmware” on the PC and then press “OK” on the

Analyzer.

23
 g. When the update is completed on the PC, press the OK button

h. Press “OK”on the screen to complete FW Update.

5) Brightness/Volume setting
① Use , buttons or the slider to adjust screen brightness.
② Use , buttons or the slider to adjust the volume.

24
Maintenance Menu
1) On the Maintenance tab, you can check the maintenance status and log
of each item.

① ② ③ ④ ⑤

① Maintenance Area: Tested items are displayed.

② Status Area: QC scheduled date for tested item is displayed. The QC
period can be set from due date in Area ③ above.
③ Due Date Area: You can set the period of test items. Press button
to select “No QC(Off)” or set the due date by 15, 30, 45, 60, 90, 180 or
300 days.
④ Event Log Date & Time Area: Date and time of event log are displayed.
⑤ Event Log Area: History of all items tested by F2400 Analyzer is
displayed in chronological order.

Log Clear Button: Delete the selected event log.

Caution

25
 Statistics Menu
1) On the Statistics tab, you can check the number of tests, calibration, and
QC tests for each item.

④ ⑤

②
①
③

① The number of times that each test has been performed is displayed.
② The type and number of times of errors that occurred are displayed.
③ The number of times of calibrations and Q.C. for each test is displayed.
④ Period setting: Press button to set the period that you want to
check.

·Top
· Clear: Delete selecte.
·Bottom
· Clear: Delete selected Cal & QC Log.
Caution

26
Operator Menu
1) An Operator item can be registered, edited, and deleted.
·· Password in Operator is the same as the password used for log-on.

·· To add an Operator ID, press “Add” .

27
 ·· To modify the Operator ID, select the ID,, press “Edit”, type ID you wish
to modify, and then press “OK”

28
 ·· To delete the Operator ID, select the ID, select the ID, press “Delete”,
then press “ OK”

Network Menu
1) On the Network tab, you can set the HIS/LIS and Analyzer network.
For the methods of setting, consult with your interface specialist.

29
Chapter 4. Work Place
Performing a Test & Reviewing data

Before proceeding a test, check the following :

·Is
· the power cable connected to the Analyzer?
·Are
· the date and time settings of the Analyzer correct?
·Are
· all other settings correct?

1. Select the “Work Place” from the Main Menu.

2. The “Work Place” consists of 3 items: “Run Test”, “Test Status”, and “Result
Review”.

30
1) Run test Menu
“Run test” is a mode for testing the samples from patients.
① After entering patient information in “Patient ID”, press to move
to the next step.
Patient ID can be entered by using the touch keyboard. You can
also enter Patient ID by using a barcode scanner or by an external
keyboard connected by USB.
** You can also press button to proceed with the test without
enteringthe Patient ID.

② Insert the test device in the “Insert Device” step and the Analyzer will
move to the next step automatically.

31
 ③ Analyzer checks the conditions of the inserted test device. If the test
device has already been used, E-1 error pops up.

④ After confirming that the test device can be used with STANDARD
F2400, the samples should be prepared according to the instruction for
each test and applied to the sample well of the test device.

·Press
· the “Test Start” immediately after applying
the sample to the test device.
Caution

32
⑤ Analyzer checks the applied sample’s conditions and flow.

⑥ When the sample checking is completed, the test deviceis mounted

inside the Analyzer.

⑦ When the mounting is completed, you can start a new test procedure.

33
 2) Test Status Menu
“Test Status” menu shows the progress of test in the Analyzer.
Blue section is shown in the following cases:
·If
· the test is completed correctly.
·If
· the result of qualitative test is Negative
·If
· the result of quantitative test is within the normal
range.
Red section is shown in the following cases:
·If
· the test is completed correctly.
· the result of qualitative test is positive
·If
· the result of quantitative test is out of normal range
·If
Black section is shown in the following cases:
·If
· the test result is Invalid

Green section is shown in the following cases:

·If
· the test is in progress

34
 ① If you select a completed item, you can check details of the test(test
result, name label, procedural control, test date and time, Operator ID,
Patient ID, manufacturing date of the test deivce, software version). In
this window, you can print the test result by pressing on “Print”. Press
“OK” to close the window.

3) “Result Review” Menu

Result Review allows you to check the test results from “Run Test”

35
 ① Select from the drop-down list on the right. And
select a test from list shown in [Area A]. All of the test results
belonging to the selected Patient ID will be shown in [Area B]. If you
select a particular test from the drop-down list, you can see the tests
in order from the most recent ones.

A B

② If you select a test from the list in [Area B], you can see the test
details.
·· Test details window for qualitative test – Example) Influenza A/B

36
·· Test details window for quantitative test – Example) HbA1c

For quantitative test, you can change the measurement unit by

pressing the item under “Units” in the list on the right side[Area B].
(Available only when there are 2 or more types of measurement
units.)

37
Chapter 05. Calibration
Calibration Set Test
Calibration Set Test is an essential function that ensures optimal performance
of the Analyzer by checking the methods specified in the Manual.
Time for use of Calibration Set
·Whenever
· the Analyzer is turned on
·When
· Analyzer is dropped
·When
· the result does not match the desired result
·When
· you want to check the performance of the Analyzer and test
device

·Calibration
· Set test is independent from QC test and cannot
replace QC test.
Caution

Calibration mode consists of “Run Calibration” and “Calibration Review”.

1. Run Calibration Menu

Calibration can be performed in “Run Calibration”. After preparation of
Calibration Set, press button to start calibration.

38
① Insert the Cal-1 Device into the test slot of the Analyzer.

② After checking the Cal-1 Device, insert the Cal-2 Device into the test slot
of the Analyzer.

③ After checking the Cal-2 Device, insert the Cal-3 Device into the test slot
of the Analyzer.

39
 ④ After inserting all the calibration devices, the analyzers performs the
calibration analysis.

⑤ When the analysis is completed, you can check the result screen.
·· Calibration check- OK screen

·· Calibration check- FAIL screen

40
2. Calibration Review Menu
The result of calibration can be checked in “Calibration Review”.

① You can check the details by selecting the Result from the list.
·· Calibration Review - OK screen

·· Calibration Review - FAIL Screen

41
 ② Select a list and press “Delete Record”( ) to clear the selected
items. Press the “Delete All”( ) to clear all results.

42
Chapter 6. Quality Control
Quality Control Test
To verify whether the Analyzer’s system is functioning properly and whether
the test procedure is correct, perform QC with one or more levels of quality
control materials.
Time for use of Calibration Set
·When
· Analyzer is used for the first time
·When
· usinga tes device of newly opened package.
·When
· Analyzer is dropped
·When
· the result does not match the expected result
·When
· the result is lower or higher than expected even after repeated
tests.
·When
· you want to check the performance of the Analyzer and test
device
Before using the Control
·Check
· the expiration date of quality control material. Do not use after
expiration or disposal date (3 months after the package of quality control
material is opened), Consider the earlier date between those two.

QC Mode consists of “Run QC”, “QC Result Review” and “Monthly Review”.

1. Run QC Menu
Run QC consists of “QC with Control Solution” and “External QC”.

43
 1) QC with Control solution

① Select “QC with Control solution” and the next screen will be shown.

② Enter the information of quality control material (barcode number)

and press OK to proceed to the next step.

③ Insert a test device that matches the quality control material

information entered on the Insert Device screen.

44
④ The Analyzer checks the conditions of inserted test device. If the test
device has already been used, an E-1 error pops up.

⑤ When the verification of the test device is completed, apply the

control to the sample well of the test device and immediately press
“QC Start”.

⑥ The F2400 Analyzer will check the conditions and flow of applied
sample.

45
 ⑦ After the check is completed, the test device is mounted inside the
Analyzer.

⑧ Once the mounting is complete, you can start a test procedure.

2) External QC

① Press “External QC” to move to the next screen.

② Insert the test device to test on the Insert Device screen.

46
③ Analyzer checks the conditions of inserted test device. If the test
device has already been used, an E-1 error pops up.

④ When the verification is completed, a screen for setting the range of

quality control material appears.

⑤ Set the information of the quality control material to be used and

press “OK” to save the information.
·· Example of Qualitative test

47
 ·· Example of Quantitative test

⑥ After applying the prepared quality control material, press “QC Start”
immediately.

⑦ The F2400 Analyzer checks the conditions and flow of applied sample.

48
 ⑧ Once the verification is completed, the test device is mounted inside
the Analyzer.

3) QC Result review Menu

① You can check the result of QC in “QC Result review”.

ⓒ
ⓔ ⓓ
ⓐ

a. The number of times that QC was performed, average, standard

deviation, coefficient of variation, and the result of ± 2SD are
shown. For qualitative items, only the number of times is displayed.
For the quantitative items, all values are displayed.
b. The QC history of selected test is displayed in the No. 4 drop-down
list (d).
c. You can set the date for desired period.

49
 d. If you select the test you want to view from the drop-down list,
you can check the QC result of selected test.
Example) The results obtained when result retrieval period is set
to 2018.1.17-2018.4.19 and then HbA1c is selected from the drop-
down list

Example) The results obtained when result retrieval period is set

to 2018.1.17-2018.4.19 and then Strep A is selected from the drop-
down list

e. Deletes the entire QC result.

50
 ② If you select from the list, you can check the test details.

4) Monthly Review Menu

In ”Monthly Review”, you can check the monthly value of quantitative

test.
If you select the period and press “Table”, the QC results for that period
are provided in the form of a list.
Here, you can check only the result of selected test by pressing “Select
item” and selecting the desired item.
When a graph is selected, the Levey-Jennings control chart is provided.

51
Chapter 07. Cleaning & Maintenance
Cleaning of Analyzer
To prevent any malfunctioning of Analyzer, keep the test slot free from
specimen moisture or dust. Clean the Analyzer with a lint-free cloth and
suitable cleaning solution (example: mild soap, 70% ethanol or isopropyl alcohl).
If the Analyzer is in a special environment (example: operating room), it
is recommended to clean it with a mixture of 1-propanol, 2-propanol and
glutaraldehyde (trade name: Bacillol plus).

·Do
· not use abrasive cleaners or liquid preservatives.
Otherwise, the display screen may be damaged. Before
Caution cleaning, always turn off the Analyzer and disconnect the
power cables.

Maintenance and Transportation

Each time you turn on the Analyzer, the system in the Analyzer starts self
verification to find any possible problem.
·Be
· careful not to contaminate the test device slot and
internal parts of the Analyzer.
Note ·The
· carrying case is designed to store the supplied
components and to protect the Analyzer.
·The
· Analyzer must be stored and transported at -20˚C ~ 50˚C
/ -4˚F ~ 122˚F and 10%-93% RH.
·The
· F2400 Analyzer was designed to meet safety standards.
·Do
· not modify or repair the Analyzer.
·Do
· not repair the Analyzer yourself without the help of the
supplier.

52
Chapter 08. Message & Troubleshooting
Warning Message

Display Description of Warning

Warning: No user information entered
“OK” is pressed while no user information has
been entered.
Solution
First, enter the user information and then
press 'OK'.
Warning: USB not connected
USB is not connected to the Analyzer.
Solution
Make sure that USB is properly inserted into
the Analyzer.
Warning: Password error
Incorrect administrator password entered.
Solution
Enter the correct password.

Warning: No Update File

Update file is not found in USB.
Solution
Check USB for update file.
If you have confirmed that updated file is
stored on the USB, Insert the USB and press 'OK'.

Warning: Unregistered user information

The entered user information is not registered
in the Analyzer.
Solution
Add user information in setup mode.

53
 Warning: Incorrect IP address
Incorrect IP address entered.
Solution
Confirm the entered IP address, and enter
the correct IP address.

Error Message

Display Description of Warning

E01: Test device error
Inserted test device is contaminated or
already used.
Solution
Discard the failed test device and retest with a
new test device.
E02: Insufficient sample volume
Insufficient sample is applied.
Solution
Discard the failed test device, and test again
by dropping sufficient volume of sample on
new test device.
E03: Expired test error
A test device was used after expiration date.
Solution
Perform the test again with new test device
that has not exceeded the expiration date.

54
E04: Temperature error
The ambient temperature deviates from
the operating temperature range of the test
device.
Solution
Move the Analyzer and test device into
proper temperature range and perform
the test. Do not artificially heat or cool the
Analyzer.

E05: Communication error

Communication between Analyzer and
barcode or between Analyzer and printer has
failed.
Solution
If the error persists after rebooting the
Analyzer, consult the SD Biosensor.

E06: Total hemoglobin amount error

The total hemoglobin measured deviates
from the range of 7-23 g/dL.
Solution
Test again with a new test device.
If the error persists after rebooting the
Analyzer, contact the SD Biosensor.

55
 E12: Calibration overdue error
Time limit for calibration has been exceeded.
Solution
If same error persists after calibrating,
contact the SD Biosensor.

E13: Unsuitable test device error

Test device applied to Analyzer is not
suitable.
Solution
Check if the analyzer is updated with the
latest version of the software.
EEE: Analyzer internal error message
Analyzer has an internal error.
Solution
If the error persists after rebooting the
Analyzer, contact the SD Biosensor.

56
ANNEX 01. Information for Professional
Medical Personnel

Protection from Infection

Professional medical personnel must be careful to avoid infection caused
by sample, etc. while performing diagnostic test with the STANDARD F2400
Analyzer.
·· Wear medical gloves.
·· When applying sample into the sample well of test device, be careful that
the sample does not contaminate any part of analyzer.
·· Observe the relevant guidelines and regulations of healthcare, sanity and
safety.

Electromagnetic compatibility
The electrostatic discharge immunity test shall comply with the international
standard IEC 61000-4-2. In addition, this Analyzer meets electromagnetic
compatibility requirements in accordance with EN 61326 and there is no
interference with other electronic equipment.

Disposal
Dispose of the STANDARD F2400 Analyzer in accordance with local regulations
for disposal of electrical and electronic equipment. Waste Electrical Electronic
Equipment (WEEE) regulation corresponds to the European Directive
2002/96/EC for reduction of wastes from the Analyzer. Before any disposal of
STANDARD F2400 Analyzer, please contact the concerned authorities or staff.

57
 MEMO

58
MEMO

59
 F2400

Manufacturer

SD BIOSENSOR, Inc.
Headoffice
C-4th&5th, 16, Deogyeong-daero 1556beon-gil,
Yeongtong-gu, Suwon-si, Gyeonggi-do, 16690,
REPUBLIC OF KOREA
Manufacturing site
74, Osongsaengmyeong 4-ro, Osong-eup,
Heungdeok-gu, Cheongju-si, Chungcheongbuk-
do, 28161, REPUBLIC OF KOREA
www.sdbiosensor.com

60