SD Biosensor F200 User manual

USER MANUAL FOR STANDARD F200 ANALYZER
Head office 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
[phone] [phone] [email protected] www.sdbiosensor.com
Manufactured by

STANDARDTM
Thank you for your purchase of the STANDARD F200 Analyzer
This user manual contains all the information needed to use the analyzer and keep
it ready to operate. Please read this user manual carefully before using the analyzer.
Familiarize yourself with the required preparations and the measurement procedure
before performing the rst measurement. Please read the instructions which are
included in each test device package before you try testing.
If you have any questions about the analyzer, please contact your healthcare pro-
fessional or local distributor. You can also visit www.sdbiosensor.com for product
demonstrations.
Thank you again for choosing the STANDARD F200 Analyzer.

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TABLE OF CONTENTS
CHAPTER 01. General Information ............................................................... 6
Main Menu Structure...............................................................................6
Symbol and Abbreviation......................................................................10
Brief Precautions and Limitations.........................................................12
CHAPTER 02. Introduction ........................................................................... 13
Intended Use..........................................................................................13
Product Description...............................................................................13
Before You Start Testing........................................................................13
Specications.........................................................................................15
CHAPTER 03. Setting and Performing ....................................................... 18
Operating the Analyzer..........................................................................18
Performing a Measurement...................................................................37
CHAPTER 04. Using the Analyzer Memory and Data Transfer............... 44
Displaying Stored Measured Values.....................................................44
Send Results..........................................................................................45
CHAPTER 05. Quality Control ...................................................................... 47
Control Test ............................................................................................47
How to Run the Quality Control............................................................47
CHAPTER 06. Calibration Set....................................................................... 51
Calibration Set Test................................................................................51
How to Run the Calibration Set Test ....................................................51
CHAPTER 07. Cleaning and Maintenance ................................................. 54
Cleaning the Analyzer............................................................................54
Maintenance and Transportation ..........................................................54

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CHAPTER 08. Screen Messages and Troubleshooting ........................... 55
Warning Messages ................................................................................55
Error Messages......................................................................................57
ANNEX 01. Information for Healthcare Professionals......................... 60
Protection against Infections ................................................................60
Electromagnetic Compatibility .............................................................60
ANNEX 02. Reference............................................................................... 61

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CHAPTER 01. General Information
Main Menu Structure
Main
Menu
Standard
Test Read Only Review
QC Calibration Supervisor
Login Login QC
Result
Patient
Result
Detailed
Result
Search
Send
Result
Select
Select All
Delete
Delete All
Calibration
Result
Load/
Save
Manage
Operator
InfoSetting
Update
Password
Insert
Device Insert Device
Device
Check Device Check
Apply
Sample Analyze
Sample
Check Finish
Analyze
Finish
Login
Insert
Device
Eject
Device
Insert
Device
Eject
Device
Insert
Device
Analyze
Finish
Login
Insert
Device
Device
Check
Apply
Sample
Sample
Check
Analyze
Finish

7
CHAPTER 01. General Information
Main Menu Structure
Main
Menu
Standard
Test Read Only Review
QC Calibration Supervisor
Login Login QC
Result
Patient
Result
Detailed
Result
Search
Send
Result
Select
Select All
Delete
Delete All
Calibration
Result
Load/
Save
Manage
Operator
InfoSetting
Update
Password
Insert
Device Insert Device
Device
Check Device Check
Apply
Sample Analyze
Sample
Check Finish
Analyze
Finish
Login
Insert
Device
Eject
Device
Insert
Device
Eject
Device
Insert
Device
Analyze
Finish
Login
Insert
Device
Device
Check
Apply
Sample
Sample
Check
Analyze
Finish

8
Send Results
Send Unsent Results
Send All Results
Send All QC Results
Send Last Reults
Send All Patients Results
Send Selected Results
Manage Operator
Add
Edit
Delete
Load / Save
Settings Load
Load
Save
Save
Operator ID
Save Test Records
Update
S/W Update
F/W Update
Info
View Version
View Network

9
Settings
Set Print Option
Set Timeout
Set Calibration and QC
General Settings
Instrument Name
Date/Time
Units
Language
Network
LIS
Parameters Volume/ Brightness

10
Symbol and Abbreviation
The symbols and abbreviations may appear on the packaging, on the labels, and
in the instructions for the STANDARD F200 Analyzer.
Symbol
Symbol 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 for the system
Crossed out wheeled bin
Discard it separately from other household waste
Fulll 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

11
Abbreviation
Abbreviation Description
Comm Communication
LIS Laboratory Information System
HIS Hospital Information System
GUI Graphic User Interface
S/W Software
F/W Firmware

12
Brief Precautions and Limitations
Caution
To reduce the risk of analyzer damage
· For in vitro diagnostic use.
· Keep the STANDARD F200 Analyzer on a at and dry surface
and avoid direct sunlight when operating.
· The analyzer has internal correction for normal levels of
ambient light, but highly intense light falling into the analyzer
may cause serious interference for the result, so it must be
avoided.
· Never move the analyzer while a test is in progress.
· Do not drop the analyzer as it could damage the unit.
· Do not attempt to disassemble the analyzer.
· Do not immerse the analyzer in water or cleaning solutions.
To reduce the risk of incorrect results
· The analyzer should be used by trained operators.
· Do not use if the analyzer is displaying an error message that
cannot be corrected.
· To obtain accurate result, refer to the instructions included
in each test device package for test storage and system
operating conditions.
· Using test devices that are expired can cause the results to be
inaccurate.
Potential
Biohazard!
To reduce the risk of biohazard
· Dispose of used specimens in accordance with federal, state
and local requirements.
· Treat specimens as potentially biohazardous material.
· Seek specic training or guidance if you are not experienced
with specimen collection and handling procedures.
· Use of nitrile, latex, or other gloves is recommended when
handling patient specimens.

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CHAPTER 02. Introduction
Intended Use
The STANDARD F200 Analyzer works for measuring quantitative or qualitative
biomarker with body uid such as blood, urine, nasal mucus, and so on based
in vitro diagnostic assays in laboratory and point-of-care settings. The analyzer is
indicated for monitoring and diagnosing from the body uid parameter in clinical
settings by healthcare professionals. The analyzer should be used with the
specied test device which produced by SD BIOSENSOR, Inc. Refer to assay-
specic package insert for details on specic tests.
Product Description
The STANDARD F200 Analyzer can read the lot of the specific test devices
in use by checking their 2D barcodes. While the test device is inserted into
the STANDARD F200 Analyzer, the application well of the test device would
be illuminated by UV or RGB LED (light-emitting diode) with scanning. Before
performing the measurement, the type of the light reected determines the way
the test device is reected. When the specimen is applied, the specimen would
act an enzymatic reaction with forming dye and the amount of formed dye would
be proportional to the concentration of specimen. The intensity of visual color or
uorescence can be measured by illuminating with motor and LED, and detected
by reflectance photometry. The measured value takes into account the signal
strength of the light, measured blank value previously and the reads information
including 2D barcode data. Finally, the test result would display on its screen and
be stored in the memory of the analyzer simultaneously.
Before You Start Testing
Note
Read and follow the instructions carefully in the user’s manual and
Instructions for use of the test device and control. It is very important
to follow the instructions in order to prevent an incorrect result or
improper treatment.
Before use, please check the latest version of software from your
distributor and head ofce. Then update and start measuring.

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Samples
The STANDARD F200 Analyzer should be only used the specic 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. We recommend that healthcare professionals
using the STANDARD F200 Analyzer to perform measurements for more than one
patient use gloves and follow all other locally applicable health and safety regulations.
Operating Conditions
To ensure proper function of the STANDARD F200 Analyzer, observe the following
guidelines.
· Operate the analyzer only within temperature 0-50°C and humidity 10-93%.
· In order to perform a measurement, place the analyzer on a at surface.
· Strong electromagnetic elds may impair the function of the analyzer. Do not
use the analyzer close to sources of strong electromagnetic radiation.
· The analyzer's air vents must be free for air (Do not cover the air vents).
· If the analyzer cause a sudden malfunction, unplug the adaptor from the outlet.

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Specications
Power Supply Input: DC 12V/5A Max
Rating Power Supply DC 12 V
Display 7" Color TFT LCD (800x480)
Display Controls Graphic User Interface
Power Consumption Max 60W
Over Voltage Category Ⅱ
Pollution Degree Ⅱ
Memory 3000
RTC RTC Backup Battery Included
LIS/HIS HL7 PCD-01 Prole Support
Size 200 x 240 x 205 mm
Labeling Manual
Contents
· STANDARD F200 Analyzer
· STANDARD F Calibration Set
Materials required but not provided
· STANDARD F Test Device
· 12V/5A AC/DC Power adaptor
· USB Barcode scanner

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Overview of STANDARD F200 Analyzer
A
B
C
E
G
H
I
J
K
D
F

17
Overview of STANDARD F200 Analyzer
A
B
C
E
G
H
I
J
K
D
F
A. Color TFT LCD
Use for displaying test screen and interacting with the graphic user interface
B. Test Slot
Part for inserting a test device to analyzer
C. Test Device
Use for proceeding the test by inserting the specied test device
D. Printer Cover
Use for covering and protecting the printer sheet
E. Printer Cover Button
Use for opening the printer cover
F. DC Jack Port
Use for connecting power supply adaptor 12V/5A to its compartment
G. Power Switch
Use for turning on/off the analyzer
H. USB x 4
Use for connecting with keyboard, barcode scanner and USB memory
Note
When using USB memory or USB storage device, the USB le
system should be formatted to the FA32 so that the STANDARD
F200 Analyzer recognizes the USB.
I. LAN
Use for communicating through the local area network
J. Mini USB
Use for upgrading the F/W upgrade by PC connection
K. Additional Device Port
Use for connecting with specic device manufactured by SD BIOSENSOR,Inc.
Accessories of the STANDARD F200 Analyzer
Accessory STANDARD F Calibration Set F CAL-1, F CAL-2, F CAL-3
Optional
STANDARD F Test Device Specic test device manufactured
by SD Biosensor, Inc.
Barcode scanner USB Barcode scanner
Printer Paper -
AC/DC Power Adaptor
Input: AC 100~240 V, 50/60 Hz
(Voltage tolerance ± 10 %)
Output: DC 12V/5A

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CHAPTER 03. Setting and Performing
Operating the Analyzer
STEP 1. Connect AC/DC adaptor jack
1-1. Place the analyzer on the bench top within reach of an electrical
outlet. The unit is portable and can be moved to a suitable location
for testing. Ensure counter top is stable, at and dry. Also check
the bench provides adequate space for the analyzer and barcode
scanner.
1-2. Plug the DC power cord into the power port in the back of the
analyzer. Plug the AC/DC adaptor power cord into the cord and
an available electrical outlet.
1-3. Once the connection is complete, the analyzer is ready for use.
STEP 2. Set the analyzer
2-1 When setting on the analyzer for the rst time, operator ID should
be registered. Initial supervisor password is 0000.
2-2 It is recommended to acknowledge following table given on the
supervisor menu.
Stage Menu Sub Menu
1Manage
Operator Add / Edit / Delete
2Load/Save Settings / Operator ID / Save test records
3Update F/W update / S/W update
4Settings
Print option Printed sheet 1/Printed sheet 2/Auto-
printing
Time out Automatic turn-off time /Insert test
device time
Calibration & QC Time period
General
Date / Time / Language / Units /
Network/LIS / Volume / Brightness
※LIS/HIS can be set only when LIS / HIS
server and connection is ready.
Instrument name Instrument name/Facility name
5Info View version / View network

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1st step: Entering set mode
1. First, touch the 'Supervisor' on the screen in the main menu to enter the set
mode and proceed the test.
2. Input the password and press the ‘OK’ for entry. Initial password is 0000.
Press the ‘Cancel’ if you want to return to the previous setting.
3. The supervisor menu allows operator to access additional functionality and
security options depending on work environment and the location of the
analyzer.

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2nd step: Supervisor>Manage operator
1. Select the ‘Manage Operator’ on the screen to add, edit or delete operator ID.
Press the ‘Back’ if you want to return to previous setting.
2. To add operator ID, press 'Add'. Also, use the touch panel keyboard or USB
connected keyboard to add the operator ID.
3. After adding the operator ID is completed, the analyzer will register it. Press
‘OK’ to conrm.