Gima BC401 Manuel utilisateur

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

gima@gimaitaly.com - export@gimaitaly.com

www.gimaitaly.com

-40˚C

+55˚C

95%

76kPa

106kPa

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-

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

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.

ENGLISH

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