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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