MP Biomedicals MPQuant User manual

USER MANUAL
Immunouorescence Analyzer
MPQuan™
www.mpbio.com
Cat. No. 07IMA001
Customer Service: diagnos[email protected]
For the in-vitro quantave detecon of various biomarkers in human serum,
plasma, and whole blood with specic diagnosc test kits.

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TABLE OF CONTENTS
Introducon ........................................................3
1.1 Intended Use ......................................................3
1.2 Scope of Applicaon ................................................3
1.3 Product Name and Model ............................................3
Components and Parameters..........................................4
2.1 Standard Equipment List .............................................4
2.2 Technical Specicaon ..............................................4
2.3 Transportaon and Storage Condions ................................5
2.4 Operang Condions ...............................................6
Principle and Structure ...............................................6
3.1 Operang Principle .................................................6
3.2 Analyzer Composion ...............................................6
Analyzer Installaon..................................................8
4.1 Environment .......................................................8
4.2 Installaon .........................................................8
4.3 Installaon Precauons ..............................................9
Instrucons for Use .................................................10
5.1 Power on .........................................................10
5.2 QC Test ...........................................................10
5.3 History ...........................................................12
5.4 Sengs ...........................................................14
5.5 Test ..............................................................18
Maintaining. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
6.1 Aenon .........................................................24
6.2 Analyzer Maintaining ...............................................24
Precauons and Idencaon........................................25
7.1 Precauons .......................................................25
7.2 Idencaon ......................................................26
Trouble Shoong, Service and Disposal................................27
8.1 Common Faults and Troubleshoong .................................27
8.2 Service and Disposal ...............................................28
Explanaon of Symbols ..............................................29
Appendix...........................................................30
A. Warranty ..........................................................30
B. Warranty Card ......................................................31

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INTRODUCTION
1.1 Intended Use
The Immunouorescence Analyzer MPQuan™ is an analyzer that based on
detecon of uorescence emied during an immunoassay with angen-anbody
interacon. The analyzer is designed to provide quantave or qualitave test
results by the examinaon of human samples with specic in-vitro diagnosc test
kits including inammaon markers, tumor markers, nephrology, diabetes, cardiac
markers, coagulaon, endocrinology, autoimmunity, infecous diseases and etc.
Immunouorescence Analyzer MPQuan™ oers the advantages of high accuracy,
strong stability and fast results. The analyzer should only be used with in-vitro
diagnosc tests manufactured by MP Biomedicals Germany GmbH as per package
insert provided with specic test kits used.
For professional in-vitro diagnosc use and Point-of-Care use.
Please read this User Manual carefully before operaon.
1.2 Scope of Applicaon
The analyzer is intended for professional in-vitro diagnosc and point-of-care use,
the analyzer and can be used in central laboratories, outpaent and emergency
departments, clinical departments or medical service instuons (such as community
health centers), medical centers, etc. It can also be used in research laboratories.
1.3 Product Name and Model
Name: Immunouorescence Analyzer MPQuan™
Model: 07IMA001

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COMPONENTS AND PARAMETERS
2.1 Standard Equipment List
Aer unpacking, check whether components are missing or damaged according to
the following packing list.
No. Parameter Descripon
1Principle Principle of Fluorescence Immunoassay
2Test formats Cassee
3Measurement Quantave, Qualitave
4Read Time <20 seconds
5Test Time Ref: Analytes
6Specimen Ref: Package Insert
2.2 Technical Specicaon
ATTENTION
Check the components according to above list. If any damage is found, please
contact your local distributor.
1x
1x 1x
2x
1x
1x 1x
Analyzer MPQuan™ Power Adapter
GSM60A24-P1J
Print Paper Roll
57*30mm
Power Cord
Touch Pen
User Manual
QC Test Cassees

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2.3 Transportaon and Storage Condions
2.3.1 Packaging
Packing cases should be reinforced with shockproof liners and moisture-proof
packing (plasc bags).
2.3.2 Transportaon
Temperature: -30 °C ~ 55 °C.
Relave humidity: ≤85%.
Environment: no toxic gases, ammable, explosive substances and corrosive
gases are allowed. Aenon should be paid to moistureproof, shock and
severe vibraon during transportaon.
2.3.3 Storage
Storage temperature: 5 °C ~ 45 °C.
Relave humidity: ≤85%.
Atmospheric pressure: 86 kPa ~ 106 kPa, no corrosive gas.
No. Parameter Descripon
7Dimension 220 mm x 190 mm x 120 mm (L x W x H)
8Analyzer net weight 2 kg
9Screen size 7 inches
10 OS Windows-Compable proprietary program
11 Memory 10,000 records
12 Printer Built-in thermal printer
13 Ports LAN x 1, USB x 2, COM x 1

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2.4 Operang Condions
Adapter input: 100 - 240 VAC, 50/60 Hz.
Power: 60 W.
Environment temperature: 10 °C ~ 30 °C.
Relave humidity: ≤85%.
Atmospheric pressure: 86 kPa ~ 106 kPa.
PRINCIPLE AND STRUCTURE
3.1 Operang Principle
This analyzer excites the reacted test cassee which is a based on europium
microspheres marked uorescence immunoassay with a UV LED light source, then
collects, analyzes and calculates the signal from the test cassee, and gives the test
result.
3.2 Analyzer Composion
1 External View
NOTEThe appearance of the analyzer and its accessories are subject to the
physical object.
Screen: Display analyzer soware interface.
Fig. 3.2.1 Front View
Built-in Thermal Printer: Print test results.
Test Cassee Slot: Load the test cassee.

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(A) Power Switch: Power on or o the
analyzer.
(B) Power Interface: Connect the power
adapter, as shown in Fig. 3.2.3.
(C) LAN Port: Connect network cables.
(D) USB Port: To upgrade and export
data with USB disk, or connect a
scanner.
(E) COM Port: Used to transmit data to
LIS.
(F) ID Card Slot: Insert ID card here and
import informaon of the product
standard curve.
2 Power Adapter and Power Cord
3 QC Test Cassee
Fig. 3.2.3 Power adapter Fig. 3.2.4 Power cord
Fig. 3.2.5 QC test cassee
Fig. 3.2.2 Side View
(A)
(B) (C) (D) (E)
(F)

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ANALYZER INSTALLATION
4.1 Environment
MPQuan™ should be used on at indoor surfaces. Specic installaon environment
requirements are as follows:
The table top is at, the area is sucient for the installaon of the analyzer
and has sucient strength, and the surrounding environment is free from
mechanical vibraon.
The room is well venlated to ensure that the heat generated by the electrical
equipment inside the analyzer can be discharged in me.
The indoor air is clean and as far as possible without dust, corrosion and
combusble gas, cleanliness to meet the environmental standards of the
naonal clinical laboratory department.
Keep away from direct sunlight, cold and hot air sources such as air
condioners.
The altude not exceed 2,000 m.
Environment temperature: 10 °C ~ 30 °C.
Relave humidity: ≤85 %.
Atmospheric pressure: 86 kPa ~ 106 kPa.
Adapter Rate: 100 - 240 VAC, 50 Hz/60 Hz.
Power: 60 W.
There is no noise and power interference in the room.
Keep away from strong electromagnec interference sources.
4.2 Installaon
Please place the analyzer on a at table with sucient area and no vibraon. The
bearing capacity of the table is more than 2 kg and the plaorm area is >70 cm x
50 cm; Keep a sucient distance between the device and the wall. Do not place the
device in a posion where it is dicult to operate and disconnect the device. Take
out the power adapter, connect one end of the device to the power interface on the
le side panel of the analyzer, and connect the other end to the power cord then

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connect the power cord to the power supply socket. There must be good grounding
protecon, and the grounding resistance should meet the relevant naonal
standards. There should be independent and reliable ground cables in the room, and
they should not share the same line with high-power electrical equipment.
4.3 Installaon Precauons
Please choose a suitable place according to the environment, power supply
and space requirements.
The connecon between the power cord and the analyzer must be safe, rm
and in good contact. Aer conrming the connecon, start the machine.
When using, avoid direct sunlight as far as possible, and prohibit non-
professional maintainer to open the analyzer.
Please do not put water containers or metal objects on the analyzer. If water
or metal objects fall into the analyzer accidentally, unplug the power cord in
me and cut o the power supply. Find a professional to deal with it.
If there is smoke, abnormal sound, or peculiar smell, disconnect the power
supply and contact professional in me.
Please avoid the impact of external force on the analyzer.
When the analyzer is working, do not put your hand on the working area of
the analyzer to avoid injury.
Ensure that the analyzer is powered o and the power adapter is removed
while the analyzer is not working. Do not move the analyzer while the power
is on.

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INSTRUCTIONS FOR USE
5.1 Power On
Turn on the power switch . The main interface is displayed aer analyzer
inializaon (Fig. 5.1.1).
Fig. 5.1.1 Start Screen
NOTE The idener of “- ” means ON, “O” means OFF.
5.2 QC Test
Select the buon on the main interface, to enter the quality control interface,
as shown in Fig. 5.2.1.
Fig. 5.2.1 QC Test
Insert the quality control test cassee into the end of the test cassee slot in the
direcon of the arrow (Fig. 5.2.2), as shown in Fig. 5.2.3.
Fig. 5.2.2 Insert in Direcon of Arrow Fig. 5.2.3 Insert Cassee

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Fig. 5.2.8 Print QC Result
Fig. 5.2.6 Open History
Fig. 5.2.4 Open History
Touch the “QC Test” buon to start quality control test, and the results are shown in
Fig. 5.2.5.
View the quality control record
Touch the “History” buon on the main interface of quality control test to
view the record, as shown in Fig. 5.2.7.
Touch “Select All” buon to select all records.
Touch “Print” buon to print the selected quality control record.
Touch “Delete” buon to delete the selected quality control record.
Touch “Back” buon to return to quality control interface.
Fig. 5.2.5 Result QC Test
Fig. 5.2.7 View History
1
2
3
4
5
Print
Touch the “Print” buon on the main interface of quality control to print the current
quality control test result, as shown in Fig. 5.2.8.

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5.3 History
Touch the buon to enter history interface where the test result stored.
Search by Name:
Enter the paent’s name in the search bar and touch the to search, all the
test results of the paent can be queried, as shown in Fig. 5.3.1.
1
Fig. 5.3.1 Search by Name
Name query
Search by Sample ID:
2
Enter the sample ID in the search bar and touch the buon to search for all
test results under the sample ID, as shown in Fig. 5.3.2.
Fig. 5.3.2 Search by Sample ID
Sample ID
query

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Search by Test Items:
3
Enter the test item in the search bar and touch the buon to search for all
test results under the items, as shown in Fig. 5.3.3.
Fig. 5.3.3 Search by Test Item
Fig. 5.3.4 Search by Test Date
Item query
Search by Test Date:
4
Select the calendar icon on the history interface to enter the calendar
interface (as shown in Fig. 5.3.4 and 5.3.5).
Enter the target me and touch “Conrm” buon then touch buon to search
for all test result.
Fig. 5.3.5 Search by Test Date

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Fig. 5.4.1 About
About
Enter the seng interface and select “About” buon to view the soware version
number, as shown in Fig. 5.4.1, scan the QR code on the interface to watch the
instrument operaon video.
System Seng
Enter the seng interface and select “System Seng” buon to enter the system
interface, as shown in Fig. 5.4.2.
1
2
Fig. 5.4.2 System Seng
Language
Touch “Language” to choose dierent language.
Fig. 5.4.3 Language
5.4 Sengs
Touch the seng buon on the main screen “About”, “System Seng”, “Time
seng”, “Factory Reset” can be operated in this interface, as shown in Fig. 5.4.1.

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Auto Print
Select “On” or “O” buon to turn automac prinng on or o.
On: Print the result automacally aer a test nished.
O: Do not print the result aer a test nished automacally.
Fig. 5.4.4 Auto Print
Brightness
Select “+” buon to increase screen brightness.
Select “-” buon to reduce screen brightness.
Fig. 5.4.5 Brightness
Sound
Select “On” or “O” to set or turn o analyzer beeps.
Fig. 5.4.6 Sound
Export Data to
The funcon is used for data export.
The operaon is as below:
1. Insert the USB disk into the USB port.
2. Touch the USB disk buon (Fig. 5.4.7) and the data will be exported. If
the USB disk is not inserted, the interface prompts “Please insert USB
disk”, as shown in Fig. 5.4.8.
Fig. 5.4.7 Export Data to

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Fig. 5.4.8 USB is missing
During the data export process, the buon “Export Data to” turns gray (see Fig.
5.4.9). When the export is completed, the color of the buon will be restored and a
message indicang that the data export is successful will display, as shown in Fig.
5.4.10.
Fig. 5.4.9 Export Data to
Fig. 5.4.10 Data Export is successful
LIS
Before using the LIS funcon, users need to communicate with technician for
requirements and conguraon problems. Aer the funcon is opened, the test
data can be upload to LIS.
Fig. 5.4.11 LIS
Time Seng
Enter the seng interface and select the “Time Seng” buon.
3

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Fig. 5.4.12 Time Seng
Set year, month, day, hour, minute, and second based on the current me
zone. Aer seng, select “Set” buon to save seng. Touch the “Clear”
buon will clear the sengs and restore the current me.
Factory Reset
Select “Factory Reset” buon to enter the restore factory sengs interface, as
shown in Fig. 5.4.13.
Fig. 5.4.13 Factory Reset
4
In the pop-up interface, select the “Factory Reset” opon, touch “Conrm” to
clear all data and restore the inial sengs; touch “Cancel” to abandon the
factory reset.
Fig. 5.4.14 Conrm

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5.5 Test
Item Informaon Import
Step 1 Insert the ID card (Fig. 5.5.1) into the ID Card Slot, as shown in Fig. 5.5.2.
1
Fig. 5.5.2 ID Card Slot
Fig. 5.5.1 ID Card
Step 2 The ID card informaon import interface will be displayed , as shown in Fig.
5.5.3. Touch “OK”.
Fig. 5.5.3 Import is successful
Step 3 Take out the ID card aer the informaon is imported successfully.
Paent Informaon Input
Step 1 Touch the paent informaon frame on the le of the main interface, as
shown in Fig. 5.5.4, and enter the eding interface, as shown in Fig. 5.5.5.
2
Fig. 5.5.4 Paent Informaon

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Fig. 5.5.5 Eding Interface
Step 2 Edit “Sample ID”; “ Name”; “Sex”; “ Age”; “Operator”. The sample ID can be
entered manually or scanned with a scanner. Ages “Y”, “ M” and “D” are units, such
as 12M for a 12-month-old baby.
Step 3 Touch “YES” to save the paent informaon aer lling in the informaon.
Test Mode
Mode 1: Quick Test Mode
Step 1 If necessary, touch the item informaon frame and choose the “Quick Test”
mode.
Step 2 Insert test cassee.
Add the sample into the test cassee and wait for incubaon (refer to diagnosc kit
IFU). Aer the incubaon me is over, insert the test cassee into the end of the
test cassee slot in the direcon of the arrow, as shown in Fig. 5.2.2, Fig. 5.2.3.
Step 3 Touch the “RUN” buon, the analyzer automacally matches the item
informaon.
3
Fig. 5.5.6 Run

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Step 4 Conrm the Sample Type:
On the pops up interface, select “Sample Type” and touch “YES”.
NOTE When switching items, a window will pop up to conrm the sample type.
Fig. 5.5.7 Conrm Sample Type
Step 5 Display Results:
Wait a few seconds, the test result will be displayed, as shown in Fig. 5.5.8, at the
same me, the test cassee slot will pop up to exit the test cassee.
Fig. 5.5.8 Display Results
Mode 2: Standard Test Mode
Step 1 If necessary, Touch the item informaon frame (see Fig. 5.5.9) and choose
the “Standard Test” mode.
Step 2 Insert test cassee:
Add the sample into the test cassee, insert the test cassee into the end of the
test slot in the direcon of the arrow immediately, as shown in Fig. 5.2.2 and Fig.
5.2.3.
Step 3 Touch the “RUN” buon, the analyzer will automacally match item
informaon.