Warnings, Precautions and Limitations

a. Read this user manual carefully to obtain optimum performance from your
analyzer.
b. Only used for in vitro diagnostic analysis of human whole blood, plasma, serum,
urine, stool and swabs.
c. To avoid fire, electric shock or personal injuries, please turn off the power
immediately and disconnect the power plug when any liquid seeps into the
instrument, or the instrument leaks, emits smoke or a smell.
d. Take proper safeguard measures in accordance with health and safety standards
in the local country.
e. Specimens and reagents may have potentially biological risks of infection.
Operators should wear laboratory protective clothing and gloves required by the
operation regulations of laboratory safety to avoid potential biological infection
or contamination.
f. All the test kits and consumables should be disposed of after a single use. Proper
handling and disposal methods should be established by the laboratory director in
accordance with local, status and federal regulations.
g. Operators or person in charge shall be trained on cautions and operation
instructions before operating the analyzer.
h. If the instrument is used in a manner not specified by the manufacturer, the
protection provided by the instrument may be impaired.

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Symbols & Description
Manufacturer

Date of manufacture

Consult instructions for use or consult electronic

instructions for use

Serial number

In Vitro diagnostic medical device

Catalogue number

CE Mark

Authorized representative in the European

Community/European Union

Warning

Warning; Biological hazard

This way up

Fragile, handle with care

Keep away from sunlight

Keep dry

Stacking limit by number

Atmospheric pressure limitation

Humidity limitation

Temperature limit

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 Content
Warnings, Precautions and Limitations ..................................................................i
Symbols & Description........................................................................................... ii
1.Introduction............................................................................................................ 1
1.1 Intended Use .................................................................................................. 1
1.2 Product Description ........................................................................................ 1
1.3 Product Principle ............................................................................................ 1
1.3.1 Overview: Running a Test ........................................................................1
1.3.2 Working Principle .....................................................................................2
1.4 List of Icons ..................................................................................................... 2
2.Installation .............................................................................................................. 3
2.1 Unpacking ....................................................................................................... 3
2.2 Analyzer Configuration ................................................................................... 4
2.3 Main Interface ................................................................................................ 4
2.4 Performance Summary ................................................................................... 5
2.4.1 Basic Parameters .....................................................................................5
2.4.2 Performance Indexes ...............................................................................5
2.4.3 Technical Specifications ............................................................................5
2.5 Installation Requirements............................................................................... 6
2.5.1 Environment ............................................................................................6
2.5.2 Space Requirement ..................................................................................6
2.6 Setup ............................................................................................................... 7
2.6.1 Loading Paper ..........................................................................................7
2.6.2 Barcode Scanner Connection (Optional) ..................................................7
2.6.3 Lithium Battery (Optional) .......................................................................7
2.6.4 Power Connection....................................................................................7
3. Operation .............................................................................................................. 8
3.1 Preparations before Power On ....................................................................... 8
3.2 Power On ........................................................................................................ 8
3.3 SD Card Calibration ......................................................................................... 8
3.4 Sample Test .................................................................................................... 9
3.5 Result Query ................................................................................................. 10
3.5.1 Query .....................................................................................................10
3.5.2 Result Deletion.......................................................................................11
3.5.3 Test Report ............................................................................................12
3.6 Shutdown...................................................................................................... 13
3.7 Waste Disposal ............................................................................................. 13

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4.Settings ................................................................................................................. 14
4.1 Communications Setting ............................................................................... 14
4.2 Print Setting .................................................................................................. 15
4.3 Test Setting ................................................................................................... 16
4.4 Reaction Time ............................................................................................... 16
4.5 System Setting .............................................................................................. 17
4.6 System Version.............................................................................................. 17
4.7 Debug Mode ................................................................................................. 18
5.Maintenance and Troubleshooting ...................................................................... 19
5.1 Maintenance ................................................................................................. 19
5.2 Precautions ................................................................................................... 19
5.3 Troubleshooting............................................................................................ 20
6. Appendix .............................................................................................................. 21
6.1 Copyright ...................................................................................................... 21
6.2 Statement ..................................................................................................... 21
6.3 Manufacturer Responsibility......................................................................... 21
6.4 Analyzer Lifespan .......................................................................................... 22

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 1.Introduction
1.1 Intended Use
Getein 1100 Immunofluorescence Quantitative Analyzer (hereinafter called Getein
1100) is an analyzer for processing Getein test kits and analysis of markers for
cardiovascular diseases, renal diseases, inflammation, fertility, diabetes mellitus,
bone metabolism, tumor and thyroid. This manual contains instructions for the use
of Getein 1100 and general instructions for testing specimens and quality control
materials.

1.2 Product Description

Getein 1100 is used to measure concentration of biomarkers in human whole blood,
serum, plasma, urine, stool and swabs. The results can be used as an aid in clinical
diagnosis of laboratory and point of care testing.

1.3 Product Principle

1.3.1 Overview: Running a Test
Apply sample (for example, serum) to the test card, insert the test card into Getein
1100 after a certain time (outside mode) or immediately (inside mode) and click the
“Start” icon. Then the concentration of biomarkers in the sample will be measured
and the result will be displayed (Fig.1-1). The test results can be transmitted to the
lab or hospital information system (LIS or HIS) when the analyzer is connected to a
computer.
Inside Mode (single sample rapid test mode)

Dispense sample Insert test card Click “Start” Show and print result
Quick mode (mass samples rapid test mode)

Dispense sample Time the reaction manually Click “Start” Show and print result
Fig.1-1 Running a Test

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1.3.2 Working Principle
The detection element scans the binding area and converts the optical signal to
electrical signal. The voltage variation between test line and background has a linear
relationship with the antigen concentration which can be used to calculate the
concentration. In conclusion, the antigen concentration in whole blood, plasma,
serum, urine, stool and swabs can be calculated quantitatively according to the
optical signal of the test line.

1.4 List of Icons

Icon Name Function

Patient Information Name, Gender, Age, Sample ID and Barcode

can be edited here.

Power Connection Power is connected

Battery Built-in lithium battery.

Search Search results by name, sample ID or time.

ON Indicate the function is on.

OFF Indicate the function is off.

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2.Installation
2.1 Unpacking
Check the analyzer and accessories with the packing list (Table 2-1). If you find any
parts missing or any damages caused by improper transportation, contact your local
agent or Getein’s after-sales support immediately.
Table 2-1 Getein 1100 Packing List

No. Description Model Unit Quantity

1 Device Getein 1100 set 1
2 Power Adapter 12 V 5 A pc 1
3 Printing Paper 57 × 35 mm pc 1
4 Data Cable pc 1
5 User Manual (Device) pc 1
6 Qualification Certificate & pc 1
Warranty Card
7 Lithium Battery 6.4 Ah pc Optional
8 Barcode Scanner pc Optional

Fig.2-1 Getein 1100 and Main Accessories

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2.2 Analyzer Configuration
Getein 1100 is composed of control system, optical system, display unit, analog
signal acquisition system, mechanical drive system, etc.
Front and rear view of Getein 1100 are shown in Fig.2-2 and Fig.2-3.

Fig.2-2 Front View of Getein 1100

Fig.2-3 Rear View of Getein 1100

2.3 Main Interface

Status Information
It mainly includes the status of power, battery and SD card, current date and time.
Test Information
It mainly includes patient information, test card information and result information.
System Menu
It mainly includes Test, Search and Settings.
Test: see details in 3.4.
Search: see details in 3.5.
Settings: see details in 4.1~4.7.

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 Fig.2-4 Main Interface

2.4 Performance Summary

2.4.1 Basic Parameters
Operating Wavelength Detection Range Resolution
Model
(nm) (mV) (mV)
Getein 1100 635 ± 5 0 ~ 15000 1
2.4.2 Performance Indexes
Blank Count Voltage of the blank QC card should be less than 100 mV

Linearity r ≥ 0.95 in the detection range from 0 mV to 15000 mV

CV ≤ 2% within range [100-15000] mV;
Repeatability
CV ≤ 10% within range [0-100) mV
The voltage variation of the same standard card with a fixed
Stability
concentration tested within 1 hour should be within ±10%
2.4.3 Technical Specifications
Touch Screen 7-inch LCD touch screen, 1024 × 600

Two USB ports for barcode scanning and software update

Communications COM port for PC
Ethernet port for LIS

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Data Storage 10,000 data

Dimensions 261mm × 241mm × 115mm

Weight 2.0 kg

Temperature 10℃ ~ 35℃

Operating
Environment Relative humidity ≤ 70%
Air pressure 70.0kPa ~ 106.0kPa

Temperature -40℃ ~ +55℃

Storage Relative humidity ≤ 93%
Air pressure 50.0kPa ~ 106.0kPa

Power Supply 100 - 240V~ 50/60Hz 60VA

2.5 Installation Requirements

2.5.1 Environment
Dry, clean, flat and horizontal surface away from direct sunlight, wind, hot source,
noise source, power interferences, electronic brush type engine and mechanical
vibration.
2.5.2 Space Requirement
Place Getein 1100 at a horizontal position and reserve enough space for the reagents.

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2.6 Setup
2.6.1 Loading Paper
1) Open the printer cover.
2) Place the printing paper into the printer with carbon sensitive surface facing the
screen.
3) Pull out approximate 5 cm of paper from the roll, and then close the cover.

a). Open the printer cover b). Load paper c). Close the printer cover

Fig.2-5 Loading Paper

2.6.2 Barcode Scanner Connection (Optional)
Connect the barcode scanner via USB port in the lateral of the analyzer (see details
in the instruction of scanner).
2.6.3 Lithium Battery (Optional)
1) The battery capacity can be shown by 4 icons. They are
which represent low, medium, high and full power respectively.
2) The charging time of lithium battery is 6 hours and the battery can work for at
least 3 hours (Note: The charging time and working time will change over time).
3) To avoid being affected by the low power and extend battery lifetime, please
charge the analyzer when a low battery is indicated .
2.6.4 Power Connection
1) Use the adapter packed together with Getein 1100.
Power supply: 100 - 240V~, Frequency: 50/60Hz
2) Connect power with Getein 1100 through the AC/DC adapter.
3) Press the power switch to turn on the analyzer.

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3. Operation
3.1 Preparations before Power On
Please confirm whether the analyzer is ready for use according to the following steps
before turning on the power switch.
1) Check whether the power supply is ready or connected safely.
2) Check whether the printing paper is enough and correctly loaded.

3.2 Power On
Press the switch to turn on the analyzer, and then system will start its self-checking
and then enter the Test Interface.
Test Interface mainly includes Patient Information, Test Card Information and Result
Information. Users can input patient information and select test item, sample and
test mode as required (Fig.3-1). Barcode can be scanned through the scanner or
inputted by the user; No. is generated automatically and cannot be modified.

Fig.3-1 Test Interface

3.3 SD Card Calibration

To guarantee the accuracy of measurement and the comparability of data,
calibration is required before patient samples testing. Please use the corresponding
SD card to calibrate the analyzer before testing different batches of kits (Note: SD
card for different batches cannot be exchanged).
Steps: Attach the SD card to the SD card recognition zone, and the analyzer would
show the prompt. Click “OK” to import the test card parameters (Fig.3-2).
Note: User can also insert the SD card into the SD card slot to do the calibration.

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 Fig.3-2 SD Card Calibration

3.4 Sample Test

User can perform sample test by the following steps (Fig.3-3):
1) Edit patient’s information if needed.
2) Click “Start” after inserting the card. Test item will be auto-recognized and the
result will be shown on the screen after the test is completed. Users can also see
the voltage waveform by sliding to the left.
3) Normally, the test card will auto-quit after testing. If not, click the “Quit” icon.

Fig.3-3 Sample Test

Note:
1) Do not switch the interfaces during the measurement.
2) Test items vary in sample volume and reaction time. Refer to the user manual of
the specific item for accurate information.

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3.5 Result Query
3.5.1 Query
Click the “Search” icon to switch to result query interface. There are three ways to
query results (Fig.3-4).

Fig.3-4 Query Interface

1) Input full or part of the Name or Sample ID (Fig.3-5).

Fig.3-5 Search by Name and Sample ID

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2) Select required Date & Time (Fig.3-6).

Fig.3-6 Search by Date & Time

3.5.2 Result Deletion
Select a result and slide it to the left. Click “Delete” and a prompt will be shown in
the following interface (Fig.3-7). Then Click “OK” to delete it.

Fig.3-7 Result Deletion

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3.5.3 Test Report
Click on the test result for the detailed test report (Fig.3-8). In the report interface,
three icons “Print”, “Save” and “Upload” are listed. Slide to the left to view the test
voltage waveform.
Print: click to print the test result.
Save: click to save the modifications.
Upload: click to transmit data to the information management system.

Fig.3-8 Test Report

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Patient information is editable in case that user forgets to input or input wrong
information. No., test item and result are not editable (Fig.3-9). Click the “Save”
button after editing.

Fig.3-9 Edit Patient Information

3.6 Shutdown
In any interface, user can press the switch to shut off the analyzer directly.

3.7 Waste Disposal

Liquid waste, used test cards, consumables and other wastes, including instrument at
the end of life, are considered as medical waste, industrial waste or source of
infection. Please handle them properly in accordance with local regulations.

Biological hazard
 Follow and obey lab safety rules and guideline. Wear protective goggles,
surgery gloves and laboratory coat to avoid the potential biological pollution
risks.
 Disposal of medical wastes should be in accordance with the local
regulations.

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4.Settings
The installation and debugging of analyzer are performed before it leaves the factory.
Operators can reset certain parameters in Settings to meet your laboratory’s specific
requirements.
Click the “Settings” icon to switch to the setting interface (Fig.4-1). There are 7 icons:
Communications, Print Setting, Test Setting, Reaction Time, System Setting, System
Version and Debug Mode.

Fig.4-1 Settings

4.1 Communications Setting

It mainly includes Serial Port Status, Communication Mode, Communication Test,
Communication Protocol, Communication Timeout and Barcode Test (Fig.4-2).
Note:
 Click “ ” to the right of Communication Status to enable communication
function; the system baud rate is 9600.
 Communication Mode includes Serial Port and WiFi.
 Click Communication Test to send test data through the selected serial port or
Ethernet port
 Communication Timeout (10s, 30s, 1min and 5min) can be selected as the
disconnection standard of Getein 1100 with the host computer.
 Click Barcode Test to perform barcode testing with a barcode scanner. The test
result will be displayed in Barcode Testing.
 Communication Protocol should be selected by or with the assistance of after-
sales personnel.

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 Fig.4-2 Communications Setting

4.2 Print Setting

It mainly includes Auto Print Status and Print Test (Fig.4-3).

Fig.4-3 Print Setting

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4.3 Test Setting
It mainly includes Sample and Test Mode (Fig.4-4).

Fig.4-4 Test Setting

4.4 Reaction Time

This interface displays the reaction time imported from SD card (Fig.4-5).
Note: Do not change the reaction time manually unless it is incorrect.

Fig.4-5 Reaction Time

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4.5 System Setting
It mainly includes Screen Saver, Language, System Date/Time and Factory Reset
(Fig.4-6).

Fig.4-6 System Setting

4.6 System Version

In this interface, user can check the version of analyzer, serial number (SN) and the
number of compatible assays (Fig.4-7).

Fig.4-7 System Version

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4.7 Debug Mode
Debugging functions are for Getein’s after-sales support to debug the instrument.
To avoid system parameters being modified by accident, users are not granted the
access to the debugging interface.

Fig.4-8 Debug Mode

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5.Maintenance and Troubleshooting
5.1 Maintenance
Getein 1100 requires minimal maintenance. Clean the surface with wet cloth and 70%
ethanol (Turn off the analyzer and ensure the power plug is unconnected before
cleaning in case of short circuit and electric shock). Do not clean any internal parts
or inner surface. Strong bleach solution (0.5% or higher) is forbidden as oxidant
solvent may damage the surface or the touch screen of analyzer.

Maintenance Item Every Day Every Week Every Month When needed
Dedusting √
SD Calibration A new batch used
Replace Printing Printing paper used up
Paper
Replace LED Lamp Light intensity
weakened
Replace Lithium Battery damaged
Battery

5.2 Precautions
1) Please place the analyzer at a horizontal position for good operation.
2) Under power outage situation, please wait for 30 seconds before restarting the
analyzer.
3) Only reagents supplied by Getein can be used on Getein 1100. Refer to the specific
user manual for more details.
4) Preheat the analyzer for 20 minutes before testing to ensure the accuracy and
reliability of results.
5) Dispose of the used test cards in accordance with the local regulations, as the
sample and reagents may have potential risk of biological infections.
6) Please operate the analyzer according to the requirements of the instruction for
long-term reliable work.
7) The personnel who operate the PC software should be familiar with the Windows
XP, Windows 7 system together with the software installation and uninstallation.
8) Results will be stored automatically in the analyzer and can be recovered
automatically after the analyzer is powered off. All data will be cleared if users
select "Factory Reset” function.
9) Do not disassemble the analyzer. Operation done by laypeople may damage
analyzer.
10) Please charge the analyzer when low battery is indicated.

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5.3 Troubleshooting
If there is a malfunction during operating, alarm prompts will pop up.
Error Cause Solution
Check the shelf life and test
Invalid test card No C line or shallow C line
again with a new card
Sample type Inconsistent test item and Correct the sample mode, and
selection error sample type re-test
SD card calibration not
Test item Do SD card calibration. Change a
performed or barcode
recognition error new card with a clear barcode
recognition failure
Inconsistent test card with
Re-calibration with the SD card
Lot error information stored in the
(same Lot No. with the test card)
analyzer

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6. Appendix
6.1 Copyright
Getein Biotech, Inc.
Instrument Name: Immunofluorescence Quantitative Analyzer
Model: Getein 1100
Version: V3.1
Issue Date: 2023.11

6.2 Statement
 Getein Biotech Inc. owns the copyright to this non-published manual and has
the right to take it as confidential information. This manual is provided for
operation, maintenance and repair for Getein 1100 only. Anyone has no right
to make this manual public.
 This manual contains proprietary information which is protected by copyright
law. Copyright of this manual belongs to Getein Biotech Inc. Any content in this
manual cannot be copied, reproduced or translated into other languages
without the written consent of Getein.
 No warranties of any kind are made by Getein regarding this manual. Getein
takes no responsibility for any consequential damages caused by errors in this
manual.
 Getein holds the authority of the modification for contents of the manual
without informing prior to it.

6.3 Manufacturer Responsibility

 Getein will only be responsible for instrument safety, reliability and
performance in following cases: installation, upgrade, calibration, repair and
maintenance are done by personnel assigned by Getein; users develop a
regular maintenance plan and perform strictly.
 Hospitals or institutions who use this instrument should make a regular
maintenance plan and perform strictly, otherwise inappropriate operations
may lead to instrument failure or even endanger people’s health.
 Getein will conditionally provide circuit diagram, calibration specifications and
other documents required to assist the appropriate personnel to finish
maintenance or repair under situations users can do themselves.
 Use only as directed. Getein will take no responsibility for protection failure of
the analyzer caused by the analyzer being used in a manner not consistent with
the instructions in this manual.

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6.4 Analyzer Lifespan
The lifespan of Getein 1100 is 8 years (continuous working time no more than eight
hours every day) under standardized operation and proper maintenance.

Getein Biotech, Inc.

Add: No.9 Bofu Road, Luhe District, Nanjing, 211505, China
Tel: +86-25-68568508
Fax: +86-25-68568500
E-mail: [email protected], [email protected]
Website: www.getein.com

CMC Medical Devices & Drugs S.L.

Add: C/ Horacio Lengo No 18, CP 29006, Málaga, Spain
Tel: +34951214054

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