SD Biosensor F100 Manual de usuario
STANDARD F100 ANALYZER USER MANUAL
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
Manufactured by
STANDARDTM
Thank you for your purchase of the STANDARD F100 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. Also read the package inserts of the test
strips to be used for the planned test.
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 F100 analyzer.
4
TABLE OF CONTENTS
CHAPTER 01. General Information ............................................................... 6
Main Menu Structure...............................................................................6
Symbol .....................................................................................................7
Brief Precautions and Limitations...........................................................8
CHAPTER 02. Introduction ............................................................................. 9
Intended Use: Purpose of the Analyzer..................................................9
Product Description.................................................................................9
Before You Start Testing..........................................................................9
System Components.............................................................................10
STANDARD F100 Analyzer ...................................................................10
STANDARD F100 Display .....................................................................12
Power Supply.........................................................................................13
CHAPTER 03. Setting and Performing ....................................................... 14
Operating the Analyzer..........................................................................14
Set the Analyzer.....................................................................................15
Performing a Measurement...................................................................30
Standard Test and Read Only Modes ..................................................31
CHAPTER 04. Using the Analyzer Memory and Data Transfer............... 33
Displaying Stored Measured Values.....................................................33
Delete Memory ......................................................................................33
Printing ...................................................................................................33
Data Transfer .........................................................................................34
CHAPTER 05. Calibration Set Test .............................................................. 35
Calibration Set Test................................................................................35
How to Use the Calibration Set ............................................................35
CHAPTER 06. Shut down, Cleaning and Maintenance............................ 37
Shut Down .............................................................................................37
Cleaning your Analyzer..........................................................................37
Maintenance and Transportation ..........................................................37
5
CHAPTER 07. Screen Messages and Troubleshooting ........................... 38
Warning Messages ................................................................................38
Error Messages......................................................................................39
ANNEX 01. Information for Healthcare Professionals......................... 41
Protection against Infections ................................................................41
6
CHAPTER 01. General Information
MAiN MENu STRuCTuRE
Setting
Read
Only Calibration Review
Standard
Test
Unit SetTime Set Beep Next Page Back
Date Set
Delete
Memory
Print Set F/W Info Back
F/W Version F/W Update
Back
Language
Set
7
SyMbol
The packaging materials, labels and instruction for use for STANDARD F100
analyzer may contain the following symbols or abbreviations which are listed
below with their meaning.
Symbol Description
Manufacturer
In vitro diagnostic medical device
Intended to use outside the body.
v
Consult instructions for use
Reference number
Date of manufacture
Indicate the date of manufacture for this analyzer
Serial number for this analyzer
Note
Indicate that the product is fragile and you need to handle it with care
Batch code
Indicate the lot number for this 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 product dry
Caution!
Indicate a situation, which if not avoided could result in damage to the
device or incorrect results.
Potential Biohazard!
8
bRiEF PRECAuTioNS AND liMiTATioNS
Caution
• For in vitro diagnostic use.
• Always operate the STANDARD F100 analyzer on a surface
that is level and dry and not in direct sunlight.
• STANDARD F100 analyzer has internal correction for normal
levels of ambient light, but highly intense light falling into the
analyzer may cause serious interference with the measurement
and must be avoided.
• Never move the analyzer while there is a test in progress.
• Do not drop the analyzer as it could damage the unit.
• Do not attempt to open or disassemble the analyzer.
• Do not immerse in water or cleaning solutions.
• Dispose of the battery and accessories in accordance with
local guidelines.
To reduce the risk of incorrect results
• The STANDARD F100 analyzer should be used by trained operators.
• Do not use if the analyzer is reporting an error condition that cannot be
corrected.
• To obtain accurate results, refer to the assay-specic package insert for details
on specic tests.
• Use the test kit within the expiration dating.
Potential
Biohazard!
To reduce the risk of biohazard
• Dispose of used specimens in accordance with federal, state
and local requirements.
• Treat specimens and patient samples as potentially
biohazardous material.
• Seek specic 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 samples.
9
CHAPTER 02. Introduction
Intended Use: Purpose of the Analyzer
The STANDARD F100 analyzer works to measure the quantitative or qualitative
measurement of body uid such as blood, urine, nasal mucus, and so on. The
analyzer is indicated for monitoring or diagnosing the body fluid parameter.
The STANDARD F100 analyzer should be used with the specified test strips.
This analyzer is indicated in clinical settings by healthcare professionals. The
STANDARD F100 analyzer intended to be used with the specific test strip
manufactured by SD BIOSENSOR, Inc.
Product Description
The STANDARD F100 analyzer is an optoelectronic instrument that uses a
reectance-based measurement method to evaluate the line signal (uorescent or
visible ray) intensities on the assay test strip, and a specic algorithm to determine
the quantitative or qualitative results of any target analyte(s). The analyzer
then displays the test results to the user in the screen. The result can also be
automatically printed through an external printer if it has connected to the analyzer.
Before You Start Testing
Note
Carefully read and follow the instructions in the user manual
and package inserts for the test strips and control solutions. 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 ofce. Then update and start measuring.
Samples
The STANDARD F100 analyzer should be only used the specic test strips for
STANDARD F100 analyzer. Because samples are quite different to the test strip’s
parameter, follow the instruction from the reference of the test strip’s manual.
Safety information
There is a potential risk of infection. We recommend that healthcare professionals
using the STANDARD F100 analyzer to perform measurements for more than one
patient use gloves and follow all other locally applicable health and safety regulations.
10
Operating conditions
To ensure proper function of your STANDARD F100 analyzer, observe the
following guidelines.
• The STANDARD F100 analyzer is only for interior use.
• Operate the analyzer only within the acceptable environmental conditions;
temperature: 0-50°C, humidity: 10-93%.
• In order to perform a measurement, place the analyzer on a level surface or
hold it in your hand.
• 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 AC adapter from the outlet.
System Components
Inspect the shipping container for obvious shipping damage prior to opening.
Unpack the shipping container and inspect the unit and components for damage.
STANDARD F100 Analyzer
Specication
Analyzer STANDARD F100 analyzer
Power Supply Input: AC 100~240 V, 50/60 Hz
(Voltage tolerance ± 10 %) Output: DC 5V/2A
Power Consumption Max 5W
Over Voltage Category II
Pollution Degree II
Labeling User Manual, Quick Guide
Rating Power Supply DC 5 V
Accessories of the STANDARD F100 Analyzer
Item Details
Accessory STANDARD F Calibration Set F CAL-1, F CAL-2, F CAL-3
Batteries 4 Batteries (1.5 V, AA)
Optional
STANDARD F Test Device Specic test device manufactured
by SD Biosensor, Inc.
Barcode scanner USB Barcode scanner
STANDARD Printer Portable printer
Printer paper
AC/DC Power Adaptor
Input: AC 100~240 V, 50/60 Hz
(Voltage tolerance ± 10 %)
Output: DC 5V/2A
BT Dongle
With a BT Dongle connection, checking test results in mobile application and
using a wireless printer are available.
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