Humasis HUBI-QUAN PRO User manual

Rev. 03/2016-07-28
Code No. KM/I-2153

1. Introduction
1.1 System Description
1.2 Warning, Precautions and Limitations
1.3 Specification
2. Installation
2.1 Unpacking
2.2 Contents and Part Listing
2.3 Setup
2.4 Display Description
3. Set Parameters
3.1 System Settings
3.2 User Settings
3.3 Test Settings
3.4 QC Test Settings
3.5 Device Settings
3.5.1 Device Settings
3.5.2 New Device Registration
4. Operation
4.1 Run Test
4.2 Quick Test
4.3 QC Test
4.3.1 IQC Test
4.3.2 QC Test
4.4 Results
4.4.1 System Information
4.4.2 Last Record
4.4.3 Patient Results
4.4.4 QC Results
5. Troubleshooting
6. Maintenance
7. Frequently Asked Questions (FAQs)
Table of Contents

HUBI-QUAN Pro is blood analysis instrument which can detect quantitative analysis of target in blood by utilizing
CMOS image sensor to analyze test image of disposable device.
HUBI-QUAN PRO can be used as Point-Of-Care device. It is applied with photodiode sensor system for specimen
type analysis, CMOS sensor for making quantitative analysis on analysis line, and for automatic revision system
using RFID system. These unique and differentiated features provided by HUBI-QUAN Pro automatically loads
analysis algorithm by recognizing production information and calibration information imbedded on specific
loaded device. Specimen recognition photodiode system automatically recognizes whole blood, plasma (or Urine)
and other specimens and makes analysis by loading specific algorithm, printing the result, and discharging the
test-device.
1.1 System Description
1. Introduction

1. The product is an electronic/ mechanic device and can lead to electronic shocks and physical injuries
when misused, Follow the manual when using the device.
2. Follow the precautions signs that are attached to the product.
3. Do not touch the switch or the power with a wet hand.
4. Unplug the power before cleaning the product.
5. Only authorized technicians are allowed to fix or examine the product.
6. Put the device for the use on a clean and flat surface at all times. Corrosive gases and high density
magnetism may damage the product.
7. Avoid it from direct sunlight.
8. Always wear gloves and goggles when dealing with poisonous and contagious material.
9. Watch for any abnormalities of the product.
10. When any abnormalities are found, stop the device immediately, take the appropriate actions, and call the
manufacturer company for inspection.
11. IQC Device is very sensitive with light. Keep the device in the black opaque case when it is not is use.
12. Do not move HUBI-QUAN Pro when the test is being on process. Use only UBI-QUAN Pro power adaptor. For
the distinguishing purpose, Identification card is attached to the bar code.
13. Be cautious not to drop HUBI-QUAN Pro.
14. Do not put anything on top of HUBI-QUAN Pro.
15. Avoid HUBI-QUAN Pro from water and any kind of liquid.
16. The manufacturer is not liable for any damages from the misusage of equipment or options (Barcode scanner,
power adapter, etc.) that are not provided by manufacturer.
17. Do not use other devices or equipment's with the product.
18. The manufacturer is not liable for any damages from the unverified usage of the equipment.
1.2 Warnings, Precautions and Limitations

Physical
Size(W x L x H) 255x178x92.7mm(10.2x7.1x3.7inches)
Weight 0.9 kg
Electrical 12V DC/3.4A –AC/DC Converter
Keypad 8 special function keys
Environment
Temperature 10 –40 °C
Humidity 30–75 % (RH)
Location Dry, clean, flat horizontal surface away from direct sunlight
Optical
Light source LED
Detection CMOS image sensor
Memory capacity
Flash Memory 4 GB
RAM 512MB
Patient Results 5,000
Calibration QC Results 500
External QC Results 2,000
User ID 500
Miscellaneous
OS Windows Embedded POSReady 2000
Device movement DC Motor(automatic)
RFID Reader SRT-1356ABPSL/F 13.56MHz RF Card reader
SB port 2(USB2.0)
Serial port 1(RS232C)
Thermal printer 2 inch (48mm, 384dots)
Display 4.3” TFT LCD display screen
ID Card port 1(13.5MHz RFID card)
Options
External Barcode Reader Fast ID Input the user, the patients, etc.
HUBI-QUAN Pro Data Management Program
LIS connectable Data Management Program
Test Device Specifications
Read the product manual for detail of test device.
1.3 Specifications

1. TFT LCD Screen
2. POWER button
3. Arrow Buttons
4. ENTER Button
5. EXIT Button
6. Status LED
7. Thermal Printer
8. TEST Button
9. Speaker
10. Device Tray
11. ID card port
12. Power Supply port
13. PS2 Port
14. RS-232C Serial Port
15. Lan Port
16. USB Port
Describe different operation Menu, Test status, Test results
Turn On/Off HUBI-QUAN Pro
Movement of categories in Menu
Selecting and deselecting a category in Menu
Move back the previous menu or cancel the selected action
Indicate function status
Print out the test result
Start the test
Alarm
Tray/ Door the move the device
Insertion hole for ID Card
AC/DC Power Converter Connection Port
KEYBOARD Connection Port
RS232 Serial Network Port
10/100 Base-T Network Port
USE Port for external devices such as Barcode Reader, USB Drive, etc. verified
usage of the equipment.

HUBI-QUAN Pro and accompanying items are in the box. HUBI-Cartridge and QC Control materials are not
included.
The complete HUBI-QUAN Pro carton (Cat. No. LSR-2000) contains the following items:
- HUBI-QUAN Pro (Cat. No. HBP1001)
- IQC Device (Cat. No. HBP1001-001)
- Supervisor Card (Cat. No. HBP1001-002)
- User ID Card (Cat. No. HBP1001-003)
- AC/DC Power Converter (12V, 3.4A output; Cat. No.HBP1001-004 )
- Power Cable (Cat. No. may vary by country)
- Printer paper, 1 roll (Cat. No. HBP1001-005)
- User Manual CD
Optional (not included)
- Barcode Scanner (Cat. No. HBP1001-006)
- Keyboard (Cat. No. HBP1001-007)
HUBI-QUAN Pro
AC/DC adaptor
Power Cable
Supervisor Card(1ea)
User ID Card(1ea)
IQC Device(3ea)
User Manual
2.1 Unpacking
2.2 Contents and Part Listing
2. Installation

1. Open the external wrap of HUBI-QUAN Pro, and take out HUBI-QUAN Pro from the box and the protection
vinyl bag.
2. Place HUBI-QUAN Pro on the appropriate installation place, and take out Power Converter and Power Cord
from the box.
3. Connect Power converter and power cord, and connect one end to AC card, and the other to Power Supply
port, which is on the back of HUBI-QUAN Pro.
5. Once HUBI-QUAN Pro is powered up, LED on Power
Button will light up, and HUBI-QUAN Pro software will be
initiating.
6. The user confirmation screen will be popped up, after
booting is completed. When it is set to Automatic Test
Mode, it moves to the main menu without going through
the user confirmation screen.
4. Press the Power Button, which is on the top of HUBI-QUAN Pro.
2.3 Setup

7. Inert the Supervisor ID card from the HUBI-QUAN Pro box to the card slot which is located on the right side
of HUBI-QUAN PRO. Once press button after inserting ID card, it will identify the ID and show main
menu.
8. Printing paper is included in product package. There is no need to insert additional paper. The following is
the procedures to insert new printing paper once it runs out.
Procedure for printer paper replacement
①Open the cover of the thermal printer on the right upper corner of
HUBI-QUAN Pro by pulling the cover with two fingers on each side
of it. The printer status LED will light up red at this point.
②Carefully flatten both side of the paper and place it like the
picture, the close the cover. The printer status LED should light up
green to show that the paper is correctly in place.
(Press FLED button to check if the paper is coming out the
machine properly.)

Close HUBI-QUAN Pro System
①Press the Power Button.
② Select ‘Shut down by and press to close the system.

Icon Operation Description
Normal(White)
Abnormal(Red)
Displays
connection status of Camera, Control
Board,
R F I D
r e a d e r m o d u l e , a n d T h e rm a l
P r i n t e r
▶
Camera Module connection check
▶
Control Board connection and specimen
measure
value command check
▶
RFID Module initialization and connection
check
▶
Thermal Printer connection check
▶
Miscellaneous system initialization check
Normal(White)
Abnormal(Red)
IQC Test result check Icon
▶
Shown white (normal) with IQC Test result is
Pass
or when IQC Frequency is turned off.
▶
Shown red (abnormal) with IQC Test result is
Fail
or when IQC Test duration is past. .
Normal(White)
Warning(Yellow)
Abnormal(Red)
Displays Data Storage space in the System
▶
Shown white (normal) when free space is over 20
%
in the system.
▶
Shown yellow (warning) when free space is
below
20% in the system.
▶
Shown Red when it is below 10%.
Remote Management Server Connection Status Icon
Back
-Up Data Server/Real time Data Transmission
Port
Connection
Status Icon
1. Equipment Status Icons
It is the basic icon of HUBI-QUAN Pro. On every
screen, there are five Equipment Status Icons,
which turn red when the equipment is in
abnormal status or white when the equipment is
normal status.
There are five main menus on the main screen:
RUN TEST, QUICK TEST, QC TEST, RESULTS, and
PARAMETERS
2.4 Display Description

2. Test Detail Screen
On the right upper corner of the Test Menu
(RUN TEST, QUCIK TEST) Screen, there are five
Test Process Icons. This icon is lighted in blue
as following the process of the test, and stays
blue when all the process of the test is finished.
Press Button to move back the previous
level of the test. User ID and current date is
shown on the lower part of the screen along
with the each menu’s status.
3. QC Detail Screen
There are five QC Test Progress Icons on the
right upper side of QC Test Menu Screen.
These icons light up blue with each progress
that the test takes, and stays blue once the
test is done. Press Button to move back
the previous level of the test. User ID and
current date is shown on the lower part of the
screen along with the each menu’s status
Step 1(User ID Icon)
Step 2(Test device Icon)
Step 3(Specimen Icon)
Step 4(Test progress icon)
Step 5(Test result icon) Step 1 2 3 4 5
Step 1(QC smaple device Icon)
Step 2(QC Sample Icon)
Step 3(Test device Icon)
Step 4(Test progress icon)
Step 5(Test result icon) Step 1 2 3 4 5
Label of menu User ID Current date
Label of menu User ID Current date

Heading Menu Default Parameters
SYSTEM SETTINGS
Language English
English, Korean, German, Chinese, Spanish, French
Sound On
On
or Off
Date format yy:mm:dd
yy:mm:dd
, mm:dd:yy, dd:mm:yy, 12H, 24H
Time Current time
Set TCP/IP Automatic IP
Automatic IP, Static IP, IP
-ADD, Subnet Mask, Gateway
Update
Update
USER SETTINGS
Organization
Serial
No., Organization, Department, Operator, Code No.,
Set User
List
User
Information
TEST SETTINGS
User login-in No Use
USE, No Use
Pat. ID USE
USE, No Use
Result Approve Auto
Manual
Result Print Auto
Auto,
Manual
Backup Server
-
Port
-
QC SETTINGS
Set IQC Test
Frequency None
None, 8hr, Daily, Weekly, Monthly
IQC Fail Use system
Use System, Block System
QC SETTINGS
Set QC Test
Frequency None
None, 8hr, Daily, Weekly, Monthly
SD X3 SD
X2 SD, X3 SD
Sample 1
1,
2
DEVICE SETTINGS
Test device
List
of Test device
Test
information
Test information
SET PARAMETERS function allows the user to set the
parameter with key pad and keyboard. SET
PARAMETERS function is could be only accessed
through Supervisor ID Card authorization.
Use the left/right arrow and to select a menu
from the menu screen on PARAMETERS screen.
Press moves back to the previous menu.
List of Parameters programmable
The user may set Parameters as follows.
The setting way of PARAMETER menu use external
keyboard basically; press
and buttons for setting about for possible items.
<Set PARAMETER main screen>
3. Set Parameters

System Configuration
Set the four set up categories in SET CONFIGURATION menu by keyboard or mouse. When every setting is
completed, press button to SAVE, and it will move back want to the SYSTEM SETTINGS screen. If you press
button, it will move back want to the SYSTEM SETTINGS screen without saving.
①There are English, Korean, German, Chinese, Spanish, and French. Use button to select the language
what you want to set then press button to select. English set as the default language. After selecting
wanted language press button and return the previous menu.
< System detail setting screen >
3.1 System Settings
②Sound –Press button to select ‘USE’ or ‘No USE’.
③Date - Press button to select Time Display Format. It could be selected from yy-mm-dd, mm-dd-yy,
and dd-mm-yy.
④Time –Use Keyboard to input year, month, day, hour, minute, second.
Menu Default Option Description
Language English
Korean, German,
Chinese, Spanish,
French
Menu to select language. When the language is changed
the system needs to reboot.
(All languages except for English is planned to be added.)
Time
format
Yy:mm:dd 24h mm:dd:yy, dd:mm:yy
12h
Menu
to select Time Display Format..
Sound Use No Use
Menu to enable / disable sound.
UPDATE
Menu
to update system.
Update
Insert USB storing ‘UPDATE File’ to USB port on the back of HUBI-QUAN Pro. Use button to select
UPDATE and press button.

Organization
It is the function to input the organization's information by external keyboard. Go to ‘USER SETTING’ and
press to save once the information is typed in.
<USER SETTINGS > <Organization registration>
Set User
Select SET USER from ‘USER SETTING’ and press . It will move to the User list screen, which shows all current
registered users’ ID.
<Set User selection screen>
①Registering a new user
USE to select NEW USER, and press button to move to the new user registration screen.
Use the keypad to enter the user information. Select USE of RFID Card to get Exp.Date automatically.
<NEW USER SETTING>
3.2 User Settings

②Select USE on Keyboard or Barcode after entering the user information to login the registering new.
<Registering New USER screen >
③To change or delete the existing ID, select the ID with button then press to give an option
either “EDIT” or “DELETE”. Select “Save” to edit the user information, and “Delete” to delete the user
information by button and press button to save or delete.
<Movement order of menu> <Movement order when editing or deleting>
①
③④
②
①
③ ④
②
⑤
⑥

Select “TEST SETTINGS” from the menu, which then shows the setting menu screen.
Press and to select the test condition, and press to save the selected menu.
<TEST SETTINGS Screen> <TEST SETTINGS Menu Screen>
3.3 Test Settings
Menu Default Option Description
User Log-in No Use USE, No Use
Activate
or deactivate User Log-in function. When No
Use
is
selected, the user authorization menu is become
invalid,
and
anyone can use the device
Pat. ID Use USE, No Use
Activate
or deactivate Patient ID function. No Use
is
selected,
Patient ID input process is become invalid.
Result
Approval Auto Auto, Manual
Set
Result Approve function to Manual or Automatic.
When
set
to “Manual” the test result is only saved after
the
approval
of the user.
Result Print Auto Auto, Manual
Activate or Deactivate auto print function of the test result.
Result Copy 1 1,2,3
Set
the number of pages for printing.
Maximum
copies are three.
Backup Server
IP Address Port
This
is the address to send the data when the IP address
is
set
in the ‘System Settings’ and the upload result is set
as
TCP
/IP in ‘Upload Type’. Enter using the keyboard.

1. Select “QC test setting” menu, then press button.
2. Use on setting menu and on selected menu for adjusting test condition.
3. Once press button after finishing all test condition setting, the setting will be saved. If saving is not
wanted, press button to move back to previous menu.
<QC TEST SETTINGS 메뉴화면> <QC TEST SETTINGS 변경메뉴>
3.4 QC Test Settings
Menu Default Option Description
Set QC Test
QC Frequency
None 8hr, Daily, weekly,
Monthly
Setting menu for checking period of QC test.
Sample 2 2,1
Determining
menu for number of QC sample.
SD X3 SD X3 SD, X2 SD
Setting menu for valid range of QC test result.
Set IQC TEST
Frequency None 8hr, Daily, weekly, Monthly
Setting menu for checking period of IQC test.
IQC Fail Use System Use system,
Block System
A
ctivate or deactivate equipment setting menu what if
IQC
test
result is fail.
<QC TEST SETTINGS Screen> <QC TEST SETTINGS Manu Screen>

3.5.1 Device Settings
① “Select “DEVICE SETTINGS” from the menu and press .
<DEVISE SETTINGS 메뉴화면>
②Select the device to edit or delete with and press . After editing the information, press ‘SAVE’
with . If ‘DELETE’ is selected, a window will show “Are You Sure Want to Delete?”. Select “Yes” to
delete the device or “No” to cancel deletion.
③Download New device file from Humasis and copy and insert the file in USB memory.
Insert USB Memory to USB Port where is behind of HUBI-QUAN Pro. Press ‘New’ and fine the file on a
window. Press button to save. Please refer to the “3.5.2 New device Registration” section.
<Device Selection Menu screen> <Device Editing menu screen >
<Device Deletion Menu> < Device Deletion pop-up Menu >
3.5 Device Settings

③USE button to edit the information of device.
④Press button to save the information after editing completely.
<Device Setting detail example>
-Select Marker
Use to select the marker between enabled and disable marker and press button to check /uncheck.
-Quantitative or Qualitative
Use to select either quantitative or qualitative and press button to check /uncheck.
(In case of selecting ‘Qualitative’, the result is showed an positive or negative by ref. range.)
-Ref. Range
Set Reference Range for each marker. The device is set up with the default reference range.
Use the external keyboard to change from default.
(Only change it when it is necessary within the certified range.)
-Set Performance Value
Set Correlation Function between devices to revision analysis.
Use along “Set” to select the corresponding marker and press to check/uncheck.
(Use it only when it is necessary with definite standard correlation with two markers.)
"Don’t use “DEVICE SETTINGS” menu except a set point extracted from certified standard and method.”
1. Select Marker 3. Ref. Range
2. Quantitative or Qualitative
4. Set Performance Value