GenBody Confiscope F40 Antigen Test User Manual

GenBody Confiscope F40 Antigen Test

Copyright © 2022 GenBody Inc.
The hardware and software referred to in this User Manual are protected under copyright law. Unless used for making a software copy for approved use under the copyright law, no information contained in this User Manual may be reproduced in whole or in part without the prior written permission of GenBody Inc. The information and specifications in this User Manual are subject to change without notice.

SYMBOLS

• Manufacturer.
• Date of manufacture: To indicate the date of manufacture for this analyzer.
• Serial number for this analyzer.
• Consult instructions for use.
• Caution, consult accompanying documents.
• Do not use it if the package is damaged
• Be careful as there is a risk of infection if liquid is spilled inside the instrument. Be careful as there is a biological cross-infection.
• The symbol for “KEEP DRY”.
• To indicate that the product is fragile you need to handle it with care.
• Crossed out wheeled bin: To discard it separately from other household waste.
• Direct current
• In vitro diagnostic medical device
• Authorized representative in the European Community

Precaution for Safety

Warnings and Precaution for Safety

1. For safe use of the instrument please be sure to read the User Manual thoroughly.
2. This user manual only contains exterior cleaning methods and does not contain information about calibration, repair or maintenance. In the event of a problem with the instrument, please contact your Dealer or GenBody Inc. for service.
3. Do not disassemble, repair or modify the instrument.
4. GenBody Inc. shall not be liable for any malfunction or damage to the product caused by an improper operation not covered in this manual.

Precautions for Installation the Product

1. Do not install in an unsafe place(Indoor use).
2. Do not install the instrument near flammable materials or contaminated areas.
3. Do not install the instrument near moist or direct sunlight, near heating appliances, or near magnets
4. Use the AC-DC adapter provided by GenBody Inc.
5. Connect the power cord to a grounded outlet. Ungrounded outlets may cause damage to equipment or electrical shock
6. Install the location of the outlet in an easily accessible location. In the event of an issue, disconnect the plug to completely disconnect the power.
7. When moving the instrument, do not drop or shock the instrument.

Precautions before Use

1. This instrument is for In Vitro Diagnostics Only.
2. This instrument should be used only for analysis purposes of GenBody Inc. diagnostic kits.
3. This instrument should be used by medical professionals such as doctors and medical experimental scientists.
4. Read this manual and the kit manual thoroughly before using it.
5. Check the instrument regularly for damage or contaminants.
6. Use in a well-ventilated and dry place.
7. Ensure that the battery is sufficient before using it. If not, charge it in advance before using it.

Precautions during Use

1. Do not shock or move during analysis.
2. When putting the test cartridge, place it flat into the tray and then close the tray.
3. Touch the button analysis after the tray is closed.
4. Do not press the touch screen too hard or operate with wet hands.
5. It is recommended to use Shield LAN Cable.

Precautions for Storing and Managing the System After Use

1. Used cartridges should be treated under the Medical Waste Disposal Act.
2. Do not store the instrument in a place affected by temperature, humidity, or wind and so on.
3. Store the instrument on a flat surface and avoid shock or vibration.
4. Do not place any objects on the touch screen.
5. Operation Temperature at -10℃ ~ +50℃, <80% RH
6. Storage Temperature at -10℃ ~ +40℃, <80% RH

Product Introduction

Intended Use
This product is intended to be used for in vitro diagnostic medical instruments for human body specimens and the response level is analyzed numerically and the qualitative and quantitative data will be calculated.

Principle of Analysis
Insert the sample and buffer solution into the cartridge and then open the tray and insert the cartridge into the instrument and press the start button. During the reaction time, the instrument will be running the test and the optical module inside the instrument will acquire a reactive image area of the cassette. The color signal generated in the reaction area, including the test line, is converted to a digital signal through various image processing and mathematical calculations. The converted digital signal will be displayed on the screen so that the user can judge or numerically confirm the result.

Product Components

Parts Description

• a. Ethernet port (RJ45)
• b. USB port (C-type)
• c. USB ports (2.0 A-type 2EA)
• d. Reset switch
• e. Power charging port
• f. LCD (touch screen)
• g. Power button
• h. Indicator LED
• i. Test instrument tray

Installation and Start

Powering on the system
Press the power button on the lower front of the instrument and then the instrument will illuminate red LED indicator and the instrument will start booting.
The test menu on the main screen is composed as follows:

Start the test after checking the patient’s test history

ITEM

MANAGER

| Added new items and a lot

SETTING

| Enter user information Language setting Screen setting

Date and time setting

Test results from backup and deletes Reset Lot information

Instrument information and update

Network setting

Powering off the system
Press the power button for 2~3 seconds, and press an OK button if the power off pop-up message appears on the screen to turn off the power completely.
If the instrument fails and the power off pop-up does not appear on the screen or the touchpad is not working, press and hold the power button for about 15 seconds or use the reset switch on the back of the instrument.

Enter LOT Information(QR-Code)

• Touch the TEST button on the main screen to display the information screen required for testing.
• Insert the unsampled cartridge into the tray and press the Read QR code button.
• If the QR code is recognized normally, the item information is displayed in the centre.

• If the QR code cannot be recognized or a specific item needs to be selected, touch the select icon next to the item mark(+).

You can select only items, and LOTs stored on the instrument and proceed to the next step.

• If you need to enter patient information, register by touching the (+) button in the Patient input field.
• To apply new items, you can add them through the ITEM menu on the main screen.
• To select an item through the Select icon, change the manual item select function to enable in the setting.

Incubation & Read

• Insert the cartridge with the current QR information into the tray.
• Inject the sample and touch the INCUBATE & READ button to start reading after the recommended incubation time for each item.
• If you are inspecting two types of tests or items that use two cartridges, start the sample drip continuously because the incubation runs simultaneously.
• If you want to cancel during Incubation, touch the Incubation & Read button one more time.
• If a cassette different from the QR information currently displayed is inserted, the test will not proceed normally, so be sure to proceed with the Read QR code process.

Read without Incubation

• Prepare the cartridge with the current QR information.
• Inject the sample, insert it with a stopwatch, etc. for an exact time, and insert it into the tray.
• Touch the READ button to read the results immediately.

• To obtain accurate inspection results, be sure to observe the development(incubation) time specified in each item manual.

Test Result

• Upon completion of the test reading, the following results window will appear.
• Please follow the instructions enclosed in each item kit box to read the test results.

• Touch the screen of the results window for about 2 seconds to view the detailed results of the examination.
• The examination results are automatically saved and the results can be sent to the server by touching the TRANSMIT button at the bottom left of the screen. (option) Contact the manufacturer (GenBody Inc.) for server usage.
• You can print the test results to a thermal printer. Printers can be purchased separately through the manufacturer. The printer supports Bluetooth transmission. With the printer connected normally, use the Print button at the bottom of the Detailed Result window.

If the test result is Invalid, check the following

• If the control band is not colored due to contamination or damage to the product or sample: Discard the cartridge and re-examine with the new cartridge.
• If the QR code or selected item is incorrect: Press the Read QR code button to update the information on the newly installed cartridge and proceed with the re-examination.
• Remove the inspected cartridges from the tray and discard them.

Test Patient

• List of patients
• Touch the Test Patient button on the Main Menu.
• You can search by patient ID, name, and phone number using the search bar at the top.

New patient registration

• Touch the New button in the lower-left corner of the Patient List screen.
• After accurately entering the required items for each patient’s information, click the Save button to save.

Checking patient’s testing record

• On the patient list screen, touch the patient you wish to search.
• If you want to proceed with a new test after checking the existing test history, you can proceed with the additional test by pressing the Test button.

How to monitor test results

• The RESULTS of the Main Menu allows you to manage the past test history.
• If you have more than one examination history, it is sorted in the latest order and you can scroll through many results.
• Touch each result for 1 to 2 seconds to switch to the Detailed Results window for detailed results.

Setting

• If you touch the Setting button in the Main Menu, you can set the system environment as shown below.

Other Information

System Specification

Colloidal gold-based immunoassay

Operating System| Android 10.0
 | Linux kernel: 4.19.111
---|---
Support Language| English,
USB Port| USB-A(2.0) 2 Port / Micro-USB 1 Port
Ethernet| 10/100Mbps
WLAN 2.4 GHz| 2412 ~ 2462 MHz
Bluetooth| 2402 ~ 2480 MHz
Power Supply| Bluetooth: DC 7.2V

Wi-Fi: DC 7.2V

Embedded Battery| Rechargeable Li-ion 7.2V 2600mAh
Display| 5.0-inch color LCD (with Touch)
Light source| UV LED (365nm) 4ea: max 18.48W
Camera| 4xCMOS (for measurement & reading QR)
Operating Condition| Temperature: -10 ~ 50°C

Humidity: Under 80 % R.H

Shipping & Storage

Condition

| Temperature: -10 ~ 40°C

Humidity: Under 80 % R.H

Altitude| up to 2000 m
Pollution degree| PD2
Dimension| 17.5(L) x 9.8(W) x 7.7(H) Cm
Weight| Under 590g

System Characteristics

Measurement

mode

| Incubate & read (or) No-Incubate & read

Data Capacity

| Item capacity: Max 200 items

Lot information capacity of each item: Max 100

Capacity of measurement data: Over 100K tests

Data Management

| Transmission: Using Wi-Fi & Ethernet

Backup: Download to USB memory stick (*.csv)

– Data is still stored in the device after backup

Search: Patient and measurement data

Print| External Bluetooth printer (optional)
LIS/HIS| It can be implemented by requirement (HL7 protocol)

Product classification

• Confiscope F40 : Hunam
• Confiscope F40V : Animal
• Confiscope F40D : Metabolic syndrome

Product Service

• GenBody Inc.
• Eopseong 2-gil, Seobuk-gu, Cheonan, Chungcheongnam-do, Republic of Korea
• TEL: +82-41-523-8993
• Please contact your dealer for service.

FCC STATEMENT

This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:

1. This device may not cause harmful interference, and
2. this device must accept any interference received, including interference that may cause undesired operation.

Caution: Any changes or modifications to this device not explicitly approved by the manufacturer could avoid your authority to operate this equipment.

This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment.
This transmitter must not be collocated or operating in conjunction with any other antenna or transmitter unless authorized to do so by the FCC.

This device contains licence‐exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development Canada’s licence-exempt RSS(s). Operation is subject to the following two conditions:

1. This device may not cause interference.
2. This device must accept any interference, including interference that may cause undesired operation of the device.

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