Gima BC401 User manual

ANALIZZATORE URINE
URINE ANALYZER
ANALYSEUR D’URINES
ANALIZADOR DE ORINA
URINANALYSATOR
Manuale d’uso - User manual Notice d’utilisation
Manual del usuario - Användarmanual
M-24046-M-Rev.1.03.23
PROFESSIONAL MEDICAL PRODUCTS
ATTENZIONE: Gli operatori devono
leggere e capire completamente questo
manuale prima di utilizzare il prodotto.
ATTENTION: The operators must
carefully read and completely understand
the present manual before using the product.
AVIS: Les opérateurs doivent lire
et bien comprendre ce manuel avant
d’utiliser le produit.
Contec Medical Systems Co., Ltd.
No.112 Qinhuang West Street, Economic & Technical Development Zone,
Qinhuangdao, Hebei Province, PEOPLE’S REPUBLIC OF CHINA
Made in China
Prolinx GmbH, Brehmstr. 56,40239,
Duesseldorf, Germany
BC401 (GIMA 24046)
ATENCIÓN: Los operadores tienen
que leer y entender completamente
este manual antes de utilizar el producto
OBSERVERA: Operatörer måste
läs och förstå detta till fullo
bruksanvisning innan du använder produkten
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]
www.gimaitaly.com
-40˚C
+55˚C
0%
95%
%
76kPa
106kPa

27
URINE ANALYZER
Contec Medical Systems Co., Ltd.
User Notice
1. Thanks for purchasing Urine Analyzer! Please read the User Manual carefully
before using this product. The User Manual which describes the operating
procedures should be followed strictly.
2. This manual detailed introduce the steps must be noted when using the pro-
duct, operation which may result in abnormal. Any anomalies or personal injury
and device damage arising from use, maintain, store do not follow requirements
of the User Manual, Our company is not responsible for the safety, reliability and
performance guarantees! The manufacturer’s warranty service does not cover
such faults!
3. The device with data storage function, for user losses which caused by data
loss due to device damage or user’s operation, our company does not assume
any responsibility.
4. Test strip can only choose regular products, it’s recommended to use the test
strip which supplied with the device, so better ensure the accuracy of the test.
5. Our Company reserves the right to change the content of the manual, the
contents of this manual are subject to change without notice.
Statement
This user manual contains proprietary information, which is protected by copyri-
ght. All rights reserved. Reproduction, adaption or translation, for any part of the
manual without prior written permission, is prohibited.
Our company assumes no responsibility for incidental or consequential da-
mage in use caused by any error appear in this document. In case of product
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upgrades, the information contained in this manual is subject to change without
notice.
Our company reserves the nal elucidative right.
Meaning of symbol
Note : Tips, advice and suggestions.
Warning : Warnings must be complied strictly to ensure that
the Urine Analyzer can operation normally and the test result are
correct and true.
In vitro diagnostic medical device Direct current
Class II applied Temperature limit
Consult instructions for use Atmospheric pressure limit
Serial number
%
Humidity limit
Product code Keep away from sunlight
Lot number This side up
Date of manufacture Keep in a cool, dry place
Manufacturer Fragile, handle with care
ISO7000-0659, Biohazard Imported by
Authorized representative in the European community
WEEE disposal
In vitro diagnostic medical device compliant with Regulation (EU) 2017/746

29 ENGLISH
Summary
Urine Analyzer................................................................................... 27
User Notice......................................................................................... 27
Statement........................................................................................... 27
Chapter 1 Overview .......................................................................... 30
1.1 Summarization.............................................................................. 30
1.2 Precautions for Use...................................................................... 30
1.3 Technical Specication................................................................. 31
1.4 Principle........................................................................................ 32
Chapter 2 Installation....................................................................... 33
2.1 Operation Environment................................................................. 33
2.2 Dismantlement and Installation.................................................... 33
2.3 Appearance and Structure ........................................................... 33
2.4 Power Supply ............................................................................... 35
Chapter 3 Operation......................................................................... 35
3.1 Buttons......................................................................................... 35
3.2 Power On...................................................................................... 36
3.3 Start Test ...................................................................................... 37
3.4 Power Off...................................................................................... 38
3.5 Setup Menu.................................................................................. 39
Chapter 4 Maintenance..................................................................... 44
4.1 Maintenance................................................................................. 44
4.2 Dismantle and Install the Paper Tray............................................ 45
4.3 Clean the Paper Tray .................................................................... 45
4.4 Disinfection................................................................................... 46
4.5 Waste Disposal............................................................................. 46
4.6 Troubleshooting............................................................................ 46
Appendix ............................................................................................ 47

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CHAPTER 1 OVERVIEW
1.1 Summarization
Urine test is the most common method for checking disease in clinical test, and
checking with urine test strip is the most effective method. urine test strip and
urine sample produce a chemical reaction, the color of each test color-area will
change after reaction, the corresponding test results can be obtained according
to the color change. The analyzer is researched and developed basing on
modern photoelectric and microprocessor technology for clinical inspection of
urine, and it integrates the advantages of easy and quick operation, exact result.
Features:
High-luminance and white LED, improves Signal Noise Ratio;
High-performance photoelectric receiving components, RGB tricolor test theory,
which makes the analyzer possess the function of good anti-interference and
adaptability;
User-friendly interface, features in vivid arrangement and convenient use;
With ash memory technology, automatic synchronization storage during testing
process, and the data doesn’t lose when the device power off or unexpected
shut down;
Store up to 500 test results, manage according to date and sample NO, which is
convenient for consulting;
Compatible with 8 items, 10 items ,11 items ,12 items and 14 items of test
paper(Optional based on the type of test strip);
With a rechargeable battery that can be tested anytime, anywhere.
Purpose:
The device is a semi-automatic instrument for clinical tests of human urine
with high-precision and intelligence, its research and development are based
on advanced technologies such as modern optics, electronics and computer
science. The device is used together with special test strips to test the urine
parameters in a semi-quantitative method, the parameters include PH, nitrite,
glucose, protein, occult blood, ketone body, bilirubin, urobilinogen, specic gra-
vity, leukocytes, VC, microalbumin, creatinine and urinary calcium. It is suitable
for use in hospitals, communities, clinics, epidemic and prevention stations. The
operators of this device should be professionals with clinical experience.
Life:
Under the conditions of daily maintenance, normal use time is not less than ve
years.
1.2 Precautions for Use
Note
Before using, please read the Manual carefully and strictly operate according to it.
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Please don’t use the accessories not provided by manufacture.
Please don’t use the analyzer in condition that the test strip is expired or the
device is damaged.
Please transport, install and operate the analyzer following the User Manual.
To ensure the accuracy, the operation temperature should be in range of
10°C~30°C, if exceeds this range, place the analyzer in required environment for
20~30 minutes before using.
Away from the strong electric eld (magnetic eld) when using, avoid direct
sunlight.
Use the supporting test strip which specied by the manufacturer.
Any serious incident that has occurred in relation to the device should be re-
ported to the manufacturer and the competent authority of the Member State in
which the user and/or patient is established.
1.3 Technical Specification
Test item
Glucose(GLU),Bilirubin(BIL),Specic gravity
(SG),PH,Ketone body(KET),Occult blood(BLD),Pro-
tein(PRO),Urobilinogen(URO),Nitrite(NIT),Leukocytes(-
LEU),Ascorbic acid (VC),Microalbumin(MAL),Creatini-
ne(CR),Calcium ion(UCA).(Optional based on the type
of test strip)
Test mode Single-step test
Language Italian and English
Display LCD, resolution:320*240
Communication
interface Micro USB interface, Bluetooth wireless communica- tion(optional Bluetooth)
Repeatability CV≤1%
Stability CV≤1%
Record mode LCD display, FlashROM data storage
Relative humidity ≤80%
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Power supply Built-in rechargeable lithium battery 3.7V Host computer: DC 5V, 1A
Adapter: AC 100V~240V, 50/60Hz
Test range Refer to Grads Table in appendix
Operating environ-
ment
Temperature: 10°C~30°C
Relative humidity: ≤80%
Atmospheric pressure: 76kPa~106kPa
Away from the strong electric eld (magnetic eld),
avoid direct sunlight
Bluetooth speci-
cations
Operating frequency: 2.4 GHz ISM band
Operating Range: 2402 MHz - 2480 MHz
Transmitting power: -30dB~+4dBm
Default: 0dBm
Receiving Sensitivity: -93 dBm
Air baud rate: 1Mbps
Frequency error: ±30kHz
Dimension 126mm(L)*73.5mm(W)*30mm(H)
1.4 Principle
Urine analyzer is a special dry chemical analyzer. Through the interpretation of
the test strip, the content of various related components in urine was calcula-
ted. Generally includes mechanical systems, optical systems, data processing
systems, etc.
The test strip contains blank color block and measurement item color block.
Each color block of the measurement item corresponds to one of the measured
indicators. Different samples contain different components to be measured, so
that the test strip block generates different shades of color, and the intensity of
the reected light is also different. Photocells are used to measure the intensity
of the reected light, the electrical signal is converted and sent to the data
processing system. The data processing system calculates the reectance of
each reagent block and the reectance of the blank block, and compares with
previously stored reectance and a curve representing the concentration of the
analyzed component, then a semi-quantitative rank symbol and concentration
value is displayed.
This device uses dual wavelength to determine the color change of the module.
The main wavelength is the sensitive characteristic wavelength of the module to
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be measured, secondary wavelength is used to eliminate the inuence of back-
ground light or other stray light. The reectance R test strip of test strip block:
R test strip = Tm (the reection intensity of the test strip to the measured wave-
length)/Ts (the reection intensity of the test strip to the reference wavelength)
The reectance R blank of blank block:
R blank = Cm (reection intensity of blank to measured wavelength)/Ts (reection
intensity of blank to reference wavelength)
The total reectance R is the ratio of the reectance of the test strip to the
reectance of the blank block.
R = R test strip / R blank = Tm Cs / Ts Cm
CHAPTER 2 INSTALLATION
2.1 Operation Environment
As with all precise electronic instruments, the urine analyzer should avoid
placing in high temperature and humidity environment for a long time. To get
optimal result, please keep relative stable temperature(10°C~30°C) and humidi-
ty(≤80%), and the tabletop to be placed the analyzer should be level.
Operating environment:
Temperature: 10°C~30°C
Relative humidity: ≤80%
Atmospheric pressure: 76kPa~106kPa
Transportation and storage environment:
Temperature: -40°C~55°C
Relative humidity: ≤95%
Atmospheric pressure: 76kPa~106kPa
Warning
Please don’t use the analyzer in the following places:
Direct sunlight areas or the front of open window;
There is ammable and explosive gases;
Near the heating or cooling equipment;
Near strong light-source.
2.2 Dismantlement and Installation
Open the package and remove the material used for transportation. Keep the
package for possible future transportation or storage.
1. Take out the urine analyzer from the package.
2. Remove the wrapper, take out the analyzer from the plastic packaging.
3. Check the components according to the packing list.
If there is any problem, contact our company or agent immediately.
2.3 Appearance and Structure
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2.3.1 Front View
Figure 2-1 Front view
1. LCD display: man-machine conversation window.
2. Micro USB socket: AC adapter power supply socket, interface of data tran-
smission.
3. Keyboard: 5-key touch control keyboard, operate the analyzer with the buttons.
4. Test paper tray: place the strip to be tested on it.
2.3.2 Back View
Figure 2-2 Back view
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1. Battery cover: it's need to open the battery cover when install and remove the
lithium battery;
2. Reset key: if necessary, press this button to reset the urine analyzer.
2.4 Power Supply
The device can use the built-in rechargeable battery as power supply. Connect
the urine analyzer to the AC adapter when the built-in battery power is low or it
needs to use the external power.
Steps for connecting AC adapter:
Make sure that the AC power complies with the technical specication.
Apply the Micro USB data cable accompanying with the analyzer. Plug data
cable to power interface of adapter, plug AC adapter to AC power socket.
Warning
AC power outlet must be well connected to ground (zero grounding voltage<5V).
The AC power must be stable, avoid using the same power together with hi-
gh-power appliance, and a manostat is recommended to congure.
Please turn off the power supply immediately and contact with the maintenance
center, when fog, peculiar smell or strange sound was found in device.
Hold the adapter itself when you unplug it, rather than the data cable.
CHAPTER 3 OPERATION
3.1 Buttons
Figure 3-1 Buttons
ON/OFF
button Long press this button to turn on/off the device.
Menu button
In the main interface, short press this button to switch
current test user;in the main interface, long press this
button for 2 seconds to enter the setup interface;in
other interface, execute the return operation.
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OK button Conrm the current operation; In the main interface,
press this button to start test.
Up direction
button
In the main interface, long press this button to move
the tray up; in the menu interface, press this button to
move the cursor up; in history interface, long press this
button to quickly move the cursor.
Down
direction
button
In the main interface, long press this button to move
the tray down; in the menu interface, press this button
to move the cursor down; in history interface, long
press this button to quickly move the cursor.
3.2 Power On
Under normal power supply situation, long press ON/OFF button for 1
seconds, the urine analyzer will power on and test various parts of the system,
enter the main interface after self-test, as shown in Figure 3-2:
Figure 3-2 Main interface
Note
When self-test information prompt abnormities, rst according to the user ma-
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nual to resolve abnormities. If abnormalities are still not resolved, please contact
the dealer or manufacturer.
When the device prompts to calibrate the clock after the self-test is completed,
users need to set time themselves.
3.3 Start Test
Preparation before test:
• Urine test strips that matched the device;
• Urine sample that stored no more than 4 hours;
• Absorbent paper for sucking residual urine;
• Protective gloves for preventing contamination.
After the test strip is immersed in the sample, absorb the excess sample liquid in
both sides of test paper with absorbent paper, then put the test strip at on the devi-
ce test paper tray. Keep the top of test strip is aligned with the top of test paper tray.
The main interface displays test countdown, test sample number, user name and
the name of the test item.
According to the need, operate as follows:
Short press this button once, the sample number add 1; long press this
button for 2 seconds, the paper tray out of the storehouse.
Short press this button once, the sample number reduce 1; long press
this button for 2 seconds, the paper tray back to the storehouse.
Short press this button once to switch testing user; long press this
button for 2 seconds to enter the device setup interface; during the
test, short press it to exit.
Short press this button once to begin 60-seconds countdown, enter
the test after the countdown return to zero; short press it once again
before zeroing, the countdown will directly return to zero and immedia-
tely enter the rapid test status.
Long press this button for 1 seconds, the device will power off.
Test steps:
1. Place the test strip;
2. Under the main interface, press OK button to begin testing the current
sample;
3. Begin 60-seconds countdown. After nishing the countdown or press OK but-
ton once again, the device begin to test data. If there are error messages
during the test, follow the prompt, then press OK button to continue the
measurement;
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4. Measurement is completed, display and store the test result. As Figure 3-3.
Note
• The sample number starting from 1 after the rst power-on every day,
after testing 1 sample, the sample number automatically add 1. After
power on again the same day, the sample number starting from the latest
sample number.
• Select the history sample number, you can re-test the sample and save
the latest test result.
• If an error message appears after pressing the OK button, please follow the
prompt.
• Do not place objects on the front removable part of test paper tray, in
order to avoid a collision when the tray is removed, cause the bias of test
results.
Figure 3-3 Test is completed
3.4 Power Off
Recommended to power off as follows:
1. Under the main interface, long press the direction button for 2 seconds
to make the paper tray back to the device storehouse, then long press the
direction button for 2 seconds again to make the paper tray out of the
device.
2. Remove the tray and rinse the bracket with clear water, then blot up the liquid
above and below the tray with absorbent paper.
3. Install the tray into the location where it out of the storehouse, long press the
direction button for 2 seconds to make the tray automatically back to the
storehouse.
4. Long press ON/OFF button for 1 seconds, the device will automatically
power off.
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Note
Don't directly unplug/ plug the paper tray with hand to avoid damages of me-
chanical structure.
3.5 Setup Menu
Figure 3-4 Menu
Figure 3-4 shows the device menu interface, it includes historical records, unit,
clock, language, factory settings. Select menu option through direction button
, press OK button to enter next submenu, press the menu button
in any interface to return to the previous interface.
3.5.1 Records
Historical records menu interface, as shown in Figure 3-5.
Figure 3-5 Historical records
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All records
Enter the all records query interface, each page shows 10 historical data at
most, user can page to see more historical records through direction button
, after selecting a record, press OK button to see the corresponding
record. As shown in Figure 3-6.
Figure 3-6 Historical records
User list
Query the historical test data of the selected user.
Date list
Query the historical test data of the selected date.
Send
The urine analyzer upload all test results to PC through Micro USB interface or
bluetooth equipment.
Note
Data upload function is customized according to customers' demands, Standard
models do not open this function for terminal customers.
Delete
Delete all historical data.
Note
Data can not be recovered after deletion, please operate carefully.
3.5.2 Unit
The default unit when the urine analyzer leave factory is set to plus system, if
you need change the unit, please change it through the unit menu.
3.5.3 Clock
Clock setup menu is used to modify the date and time. User can press the
direction button to modify the value in this interface, press OK button
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to save the modication of the current item and enter the next modication, after
completing modications in turn, press OK button to complete all modi-
cations, the system automatically saves the new date and time, and exit to the
device setup interface. In clock setup interface, users can press menu button
at any time to cancel modication and directly return to device setup interface.
Note
The system clock always has some cumulative error, the user should calibrate
once every two months.
Urine analyzer manages test reports according to the sample number, date
and time of test report, please input the date and time according to the facts,
otherwise it will lead to disorder of test report management.
3.5.4 Language
Set the language of device interface, the device supports both Italian and
English.
3.5.5 Factory Settings
Figure 3-7 The interface of inputing password
User password: 0000.
Modify the value of current item with the direction button , press the OK
button to save the modication of current item and enter next item, after
inputing the password, press the OK button to enter the factory settings
interface, as shown as Figure 3-8.
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Figure 3-8 Factory settings
Adjust sensitivity
Adjust the sensitivity for the currently selected test strip. During using, the
sensitivity can be adjusted when the user wants to increase or decrease the
sensitivity of the analyzer.
When you set the sensitivity, must be careful, a valid setting is recommended,
you can use urine quality control materials or homemade known content quality
control substitutes. For example: gradually dilute known content glucose, home-
made PRO standard, use standard of BLD, LEU with microscope, etc.
There are several problems should be pay attention to when use other types of
analyzers for comparison:
1. The test paper used by the analyzer made by which standard.
2. The mutual comparability of test strips which made by different standards
is very poor, the same control material test different test papers get different
results.
3. How is the repeatability of the analyzer, whether has evaluation or self-evaluation.
4. How is the quality of the test paper which used by the analyzer, in the case of
the repeatability of the analyzer is excellent, whether the repeatability of test
paper is excellent.
After understanding the above, you can securely adjust the sensitivity.
The setup interface of adjusting sensitivity is shown in Figure 3-9.
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Figure 3-9 Adjust sensitivity
Select the item which need modied, enter the sensitivity adjusting menu of
each grads in this item, as shown in Figure 3-10.
Figure 3-10 Adjust sensitivity
Press direction button to select grads value which need modied, press
OK button to enter the modication of current grads value, then modify the
corresponding value through direction button , press OK button to
conrm the modication, press menu button to cancel the modication.
After nishing modication, press menu button to exit the modication of
current item.
After moding all item, press menu button to return to the factory settings
menu.
Note
• When you set the sensitivity, must be careful, adjust the sensitivity may
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cause detection errors.
• After adjusting, the sensitivity value of the test item remains the same
size and sequence as before.
Sleep time
The device is set to enter the sleep state when there is no operation. Under
sleep state, the display is turned off, press any button can restore to the working
state at this time.
Note
Under sleep state, the device will automatically power off without operation
for 30 minutes.
System reset
Restore the system to factory settings.
Note
After restoring to factory settings, all user settings(including sensitivity
adjustment) will be restored to the factory state.
Reference value
Reference range of normal values for each item.
Quantitative display
Switch function of quantitative display. If it is on, it can be selected in Unit.
About
Display the relevant information of the device.
CHAPTER 4 MAINTENANCE
4.1 Maintenance
After daily use, the test tray should be took out for cleaning, and the remained
urine should be cleaned with absorbent paper or cotton swab in time, to avoid
inaccurate result for cross-pollution.
Often clean the analyzer with soft cloth to keep it clean. If the surface of the
analyzer is very dirty, then wipe it with clean water or neutral cleaning uid. Do
not clean with gasoline, paint dilutions, benzene compounds, alcohol and other
organic solvents. As these reagents will make the urine analyzer transmogrify,
drop lacquer, nally affect performance or appearance.
Do not clean the LCD with water, it is recommended to gently clean it with soft
and dry cloth or soft paper.
Do not repair or dismantle the device without authorization, if there are quality
problems, it can only be repaired by a factory authorized agency or factory
engineers.
Note
When cleaning paper tray, do not pollute, scratch, or use chemical solvents
to clean the white part on the top of the tray.
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4.2 Dismantle and Install the Paper Tray
Dismantle and install the paper tray according to the following steps:
Under the main interface, long press the direction button for 2 seconds to
make the paper tray back to the device storehouse, then long press the direction
button for 2 seconds again to make the paper tray out of the device.
When installing, insert the clean tray into the device from underside, hold the
paper tray gently with hand, at this time, press the direction button for 2
seconds, then the paper tray will move back to the device storehouse.
4.3 Clean the Paper Tray
Drive rack
Positioning magnet
Paper bracket
Calibration comparator block
Figure 4-1 Test paper tray
For daily cleaning, use the soft cloth dipped with distilled water or absorbent pa-
per to wipe the paper bracket and the calibration comparator block, and make
sure there is no dust, substance, nick, if any found, please replace it with dealer.
If there is urine alkali in the paper bracket, use cotton swab dipping with NaOH
(concentration: 0.1mol/L) to wipe the paper bracket, and use absorbent paper
to wipe.
Note
Please do not clean with any substance that may scrape the paper bracket
and the calibration comparator block.
Please do not clean the calibration comparator block with any solvent.
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