USER MANUAL BT Series

AUTO BLOOD CULTURE SYSTEM

Intellectual property statement

Zhuhai DL Biotech Co., Ltd. (hereinafter called DL) owns the intellectual property rights to DL
product and manual. This manual may refer to information protected by copyright or patents and
does not convey any icense under the patent rights or copyright of DL, or of others.

DL intends to maintain the contents of this manual as confidential information. Disclosure of the
information in this manual in any manner whatsoever without the written permission of DL is
strictly forbidden.

Release, amendment, reproduction, distribution, rental, adaptation, translation or any other derivative
work of this manual in any manner whatsoever without the written permission of DL is strictly
forbidden.

Responsibility on the manufacturer

Contents of this manual are subject to changes without prior notice.

All information contained in this manual is believed to be correct. DL shall not be liable for errors
contained herein nor for incidental or consequential damages in connection with the furnishing,
performance, or use of this manual.

DL is responsible for the effects on safety, reliability and performance of this product, only if:

All installation operations, expansions, changes, modifications and repairs of this product are
conducted by DL authorized personnel.

Electrical installation of the relevant room complies with the applicable national and local
requirements.

Product is used in accordance with the instructions for use.

Customer Service Department

Manufacturer: Zhuhai DL Biotech Co., Ltd.

Address: 19 Jinhaian Rd, Sanzao Town, Jinwan, Zhuhai, Guangdong 519041, P.R. China
Website: www.medicaldl.com
Tel: +86 756 6292044
Fax: +86 756 3391389
It is important for the hospital or organization that employs this equipment to carry out a reasonable
service/maintenance plan. Neglect of this may result in machine breakdown or injury of human health.

Be sure to operate the analyzer under the situation specified in this manual; otherwise, the analyzer
will not work normally and the analysis results will be unreliable, which would damage the analyzer
components and cause personal injury.

This instrument must be operated by skilled/trained clinical professionals.

Directory
1 About This Manual 01
1.1 Introduction 01
1.2 Who Should Read This Manual 01
1.3 Warning Symbols 01
1.4 Safe Symbols 01
1.5 Symbols used in the label 02
2 Understanding Your Instrument 02
2.1 Product name 02
2.2 Model 02
2.3 Test Principle 02
2.4 Application 03
2.5 Working Condition 03
2.6 Safety warning 03
2.7 Software version 04
2.8 Technical Parameter 04
3 Instrument Installation 04
3.1 Instrument Assembly 04
4 Understanding The System 08
4.1 Hardware Introduction 08
4.2 Software Introduction 09
5 Maintenance And Troubleshooting 18
5.1. General maintenance 18
5.2. Clean leaky culture bottles 18
5.3. If the bottle holder need cleaning, please follow bellowing steps 19
5.4 Error message and Troubleshooting Table 19
6 After-Sales Service 23
6.1. Warranty explanation 23
6.2. Warranty range 23
7 Delivery & Storage 23
1 About This Manual

1.1 Introduction

This chapter explains how to use your user manual, which is shipped with your BT series of Auto
Blood Culture System and contains reference information about the system and procedures for
operating, troubleshooting and maintaining the system. Read this manual carefully before
operating your system, and operate your system strictly as instructed in this manual.

1.2 Who Should Read This Manual

This manual contains information written for clinical laboratory professionals to:

1.Learn about the product.

2.Customize system settings.

3.Perform daily operating tasks.

4.Perform instrument maintenance and troubleshooting.

1.3 Warning Symbols

The following symbols are used to indicate danger and alert information on the instrument.

Symbols Meaning

There is blood in the cuvette, please wear medical gloves. Used

cuvette should be disposed as medical waste appropriately for
External of the sake of avoiding potentially biohazardous condition.
instrument
Do not touch the instrument when it is operating!

1.4 Safe Symbols

The following symbols are sticked in or on the instrument; user should comprehend the meaning.

Symbols Meaning
Caution, consult accompanying documents. Note: suggesting the users
consult to accompanying documents to get important safety information.

Protective earth (ground)

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 For in vitro diagnostic use

1.5 Symbols used in the label

Manufacturer Date of manufacture

Authorized representative Keep away from sunlight

Batch code Serial number

Keep away from rain Fragile, handle with care

Consult Instructions for use Upward

Do not stack Not for recycle

Electrical safety sign CE mark

Take out the foam sign Starting button

2 Understanding Your Instrument

2.1 Product name

Auto blood culture system

2.2 Model

BT24 BT48 BT60 BT120 BT180 BT240

2.3 Test Principle

After inoculating the sample into blood culture bottle, put the bottle into this system and incubate
itat body temperature. As the microbes rapidly grow, metabolic gase is produced. It leads to a change

02
of the color of the bottle sensor. Then, the system recognizes the change and analyzes by multiple
algorithm, and give the result by sound alarm and door flashing and presenting on the operation screen.

2.4 Application

The system should be used with the blood culture bottles produced by Zhuhai DL Biotech. Co.,Ltd..
And it is used for the detection of microbial in human blood or other sterile body fluids under normal
conditions through in vitro culture by medical, health, and scientific research organizations

2.5 Working Condition

Ambient Temp. : 10℃ 30℃

Relative humidity: ≤ 80%
Light illumination: Avoid direct sunlight
Power supply: AC100V-240V 50/60HZ± 1HZ
Atmospheric pressure: 76kPa~106kPa

2.6 Safety warning

The device records the patient's names, barcodes and blood test results. All the data is stored in the
database which is set for authority control;

The equipment reserves a wired network interface. The owner of the equipment should ensure that
the equipment is in a safe network condition. It is forbidden to install other software, and refer to the
following inspection items.

Inspection items Contents

Hardware Inter (R) celeron (R) CPU J1900 @ 1.99GHz/2.0GB

System Windows 7 / Windows 10

Network conditions RJ-45 port, Standard TCP/IP protocol

Application software Auto blood culture system

Support software My SQL5.5

Safety software 360(WIN7) / Microsoft Defender (WIN10 inside )

USB port Connecting mouse

03
2.7 Software version

V1.

2.8 Technical Parameter

Power Net Gross

Capacity Size
Model Composition consumption weigh weigh
(cell) ( mm )
(VA) (Kg) (Kg)

BT24 Host unit 130 24 Instrument size: 12.5 18

Host417×271×262
Sub 378×264×262
BT48 Host unit + 1 Sub Unit(24 cells) 240 48 24 36
Package size:
420×550×480

BT60 Host unit 230 60 Instrument size: 27 55

Host580×376×361
BT120 Host unit + 1 Sub Unit(60 cells) 460 120 Sub 540×376×361 53 110

BT180 Host unit + 2 Sub Unit(60 cells) 690 180 79 165

Package size:
BT240 Host unit + 3 Sub Unit(60 cells) 920 240 698×506×561 105 220

Remark: 1. The way to differentiate the Host unit and Sub unit is to check if there is a monitor.
The data in Sub unit is designed to export to Host unit and be recorded.

2.8.1 Product Performance

Accuracy 100%
Repeatability 100%
Fuse Requirement F2AL 250V

3 Instrument Installation

3.1 Instrument Assembly

The Blood Culture System must be placed on a flat, solid working table.
04
3.1.1 Circuit wiring

The Blood Culture analyzer is wired according to its sketch

Before replace insurance tube inside fuse, please insure that system and power supply are closed.
Fuse specification: 2A/250V/20mm, Type code: F2AL250V.

Display
Constant temperature system for Detection result shown
(Human-PC
blood culture detection cell in the interface
interaction)

Bottle
swinging

Stepper Bluetooth mouse and

Logical Control System Embedded System
motor keyboard

Extension The Internet of

main connector Things(IOT)

3.1.2. Configuration:

Standard Configuration

SN Description Quantity

1 Main Unit 1

Standard accessories kit includes:

SN Description Quantity

1 Power Supply 1

2 User Manual 1

3 Keyboard 1

05
 4 Mouse 1

5 Tag 1

6 Quality Certificate 1

3.1.3. Power supply:

Well grounded mains power

3.1.4. Installation

Place the instrument on a stable flat surface, make it more than 20cm away from the wall or other
obstacles;

1.Connect the monitor communication cable to the VGA in the rear of the machine;

2.According to working condition, connect the power supply.

3.1.5. Input&Output port

Port Name Instruction

HDMI Standard HDMI display device

VGA Standard VGA display device

Output
NET Use RJ45 connector network cable to connect to LIS system

USB Keyboard & Mouse

OUTPUT Communicate cable to the Sub unit

Input Power Power supply cable

INPUT Communicate cable to the Host unit

06
The Rare view:

HDMI

VGA Instrument
Switch

Network Cable
socket
Output cable to
Sub unit
USB Socket

Power supply socket

Dialing code

Power Switch

3.1.6. Dial code

Dial to identify each Sub detection bin. The code 0001 represents 1 for Sub 1 , the 0010 represents
2 for Sub 2, and so on. The connection and dialing are as below:

07
4 Understanding The System

4.1 Hardware Introduction

4.1.1. Host detection Unit

It contains touch screen, detection system, embedded control system, independent cell heaters,
constant temperature control system and mechanical system.

1
1 Frame
5
2 2 detection module
6 3 Indicator light
3 7
4 Door
8
5 Power supply
4 9 6 Barcode scanner
7 Swing structure
8 Door sensor
9 Display
10 10 Bottom shell
11 Incubator
11

4.1.2. Sub Incubation Unit

It contains detection system, independent cell heaters, constant temperature control system and
mechanical system.

1 1 Frame

2 2 detection module
5
3 Indicator light
6
7 4 Door
3
5 Power supply
8
6 Barcode scanner
4 9
7 Swing structure
10
8 Door sensor
9 Bottom shell
10 Incubator

08
4.2 Software Introduction

4.2.1. Start up

Turn on the power switch on the instrument rear panel , and press the instrument switch. After the
system boot is completed, the following screen will be displayed (Pic. 1) :

Pic. 1

The menu:

Curve: To check the test value and growth curve of the bottle, and print the curve and data.

Statistic: See the statistic of the recorded bottles.

Setting: To change the specification of alarm setting, detection time, ability of the cell and gateway,
IP and so on

Debugging: To calibrate the detection racks and cells and Touch screen calibration

About: To see the version of the software and the manufacture information

Restart: To restart the software

09
The icon explanations:

Empty bottle: there is no bottle in the cell

Incubating: there is a bottle incubating in the cell

POS: the bottle turns positive in the cell

NEG: the bottle turns negative in the cell

Invalid: the cell is not available for use

U POS: the unscanned bottle turns positive in the cell

U NEG: the unscanned bottle turns negative in the cell

Total: the quantity of bottles in the system

The status of the bottles:

Click on the bottle icon to input the patient name and view the information, including barcode and
bottle type, loading time, alarm time, time length of positive sample and the growth curve as shown
in Pic. 2.

Pic. 2

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4.2.2. Bottling

Open the door, scan the barcode of the bottle and insert it into the unit and close door. the following
screen will be displayed (Pic. 3) :

Pic. 3

Attention:

1.Before bottling, check every tested bottle carefully. When the bottle is damaged, it can’t be used.

2.Barcode must be input when bottling. Otherwise, it’s marked anonymous bottle and presented on
the screen; If insert the bottle without clicking on the button “confirm”, it will be marked as
anonymous bottle, too.

3.When take the anonymous bottle out, its bar code should be recorded, avoiding the lost of its
information.

4.If the bar code is used before, the system should have saved its data. Then this bottle is not allowed
to be loaded again.

5.Please insert the bottle in available incubation unit, otherwise, system won’t record any data or give
any warning.

6.Please read the instruction of blood culture bottle for further reference.

11
4.2.3. Bottle Unloading

Open the door and take out the bottle. Once the bottle is unloaded, its bar code should be shown up
on the screen (Pic.4). Click on “Unload” . If it’s anonymous, input the bar-code by scanning it.

Pic. 4

4.2.4. Debugging

Click on “Debugging” on the home page, Pic. 5will show up. Only authorized engineer is allowed
to operate further.

Pic. 5
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4.2.5. Print Curve and growth value

4.2.5.1. Printer connection

Connect the wire between the printer and the instrument, start up the instrument, then press “Esc”
on the keyboard, we can go to the desktop, and search the printer from the System/Administration
/Printer.

Check the website of the printer’s brand, and download the driver for window 10, and install it in
the system.

4.2.5.2. View the growth value and curve

Input the Barcode (capital letters ) or Cell No., then click Search. It shows the value list of the certain
bottle, shows as Pic 6.

Pic. 6

Click “Curve” icon to view the growth curve, X represents the detection time, Y represents the test
value, shows as Pic 7.

13
 Pic. 7

Click “Print” , the dialog box will come out, select the start time and the end time(less than 7 days, or
it will print too much) . Then it shows as Pic.8, and print the report.

Pic. 8

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4.2.6. Statistics

Click “Statistics” menu to view the statistics data, as in Pic. 9.

Click “Details”, it presents the information of the cells with loading time, name, barcode, bottle type,
status, alarm time, and time length of positive sample.

Pic. 9

Click “ Total” , it presents the total name of positive or negative samples during selected period.

Pic. 10
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4.2.7. Setting

Click on “Setting”, Pic. 11 will show up.

Pic. 11

It presents the system parameter setting, such as test time, time limit for CODE, alarm sound, scanner
light setting, invalid cell, Temperature.

Phrases Explanation:

Test Time ------ To set the maximum test time (day). The system default is 5 days. Users are allowed
to set the time freely.

Time limit for CODE ------ To set the maximum time of scanning the barcode when take out the
anonymous bottle.

Alarm sound ------ To set the alarm sound.

Unit ------ To select which unit to be set.

Scanner light ------ To set the light of the scanner.

Invalid cell ------ To set the dis-functional cells.

Temperature ------ To set the detection rack heating temperature.

16
4.2.8. About

Click “About” to view the version of current system, it indicates the information about the software:
the version, time, property, website link, address of the producer, as in Pic. 12.

Pic. 12

4.2.9. Restart

Click on “Restart” , to choose to reboot the program, as shows in Pic. 13 (Data will be saved every
10 minutes. When the incubation period is less than 10 minutes, there is no data in the system).

Pic. 13
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Attention & requirements

1.Please read this instruction before using the instrument.

2.The installation environment should be clean and anti-dust at the temperature below 35℃ , avoiding
that the air conditioner blows directly the instrument. Power supply should be stable. 1000VA is
preferred.

3.Please inspect the blood culture bottle before using it. If broken, please stop using. Otherwise,
it may damage the instrument.

4. The instrument screen is touchpad. Please don’t use sharp objects to touch the screen. If touch
screen function is lost, users can operate it with a mouse.

5. If the instrument fails, please record the information on the display, and notify the relevant
engineering and technical personnel.

6. Used blood cultures should be dealt with well in order to prevent biological contamination.

7. This product should be used by qualified health care workers in the medical facilities.

Contraindications

None.

5 Maintenance And Troubleshooting

5.1. General maintenance

Wipe the instrument with a wet towel, then dry it with clean towel.

5.2. Clean leaky culture bottles

5.2.1 Surface disinfection

Immediately disinfect the bottle surface with disinfectant(containing 5% chlorine) diluted by 20

times. Let the surface and bleach liquid fuse for 15-30 minutes, then wipe it with a wet towel. At
last dry it with clean towel.

5.2.2 Disinfection inside the instrument

First, check the inside situation. If the incubation unit is contaminated, take the leaky bottles out of
the instrument immediately. If the shelf is contaminated, uninstall it and immediately disinfect the
bottle surface with disinfectant(containing 5% chlorine) diluted by 20 times. Let the surface and
bleach liquid fuse for 15-30 minutes, then wipe it with a wet towel. At last dry it with clean towel.

18
5.3. If the bottle holder need cleaning, please follow bellowing steps:

1.Insert absorbent material (such as gauze) in the cell to suck liquid. Then throw material into the
biological waste drum to prevent biological contamination.

2.Use gauze to clean the inner wall of the cell with 10% bleach. Then throw it into the biological
waste drum.

3.Insert several layers of gauze, which has been immersed in10% bleach, into the cell for 15-30
minutes’ disinfection.

4.Then throw the gauze into the biological waste drum.

5.Use another gauze moistened with distilled water to scrub the inner wall of the cell.

6.Uninstall the holder and dry itself in the air.

7.If the holder is disable, please mark it and notify the relevant engineering and technical personnel.

5.4 Error message and Troubleshooting Table

Description and
Theme Recovery procedure
Error Messages
1.Check the electrical outlet and the power cord connection.
2.Check the fuses by disconnecting the power cord from the
There is no power to the
power entry module, then open the fuse cover.
system when the power
3.For continued protection, replace only with fuses of the type
switch is turned ON.
andrating indicated on the rear panel of the instrument.
Check the power cord plug to see if it is short-circuit.

1.Check the light and its welding connection.

2.Check the power outlet and the power cord connection
The power switch 3.Check the fuses by disconnecting the power cord from the
Power light is twinkling or power entry module, then open the fuse cover.
out. 4.For continued protection, replace only with fuses of the type
and rating indicated on the rear panel of the instrument.
5.If the problem persists, please contact your DL representative.

1.Check the light and its welding connection.

2.Check the voltage between the light and main board is
The start button light
DL5V or not.
is abnormal
3.Check the light circuit.
4.If the problem persists, please contact your DL representative.

The start buttoncannot 1.Check the button and its welding connection and its power
start the instrument. connection.
19
 2.Check the main board and replace it if it’s broken down.
3.Use a multi meter to check the circuit of main board.
4.If the problem persists, please contact your DL representative.

1.Check the electrical grounding of the instrument; Disconnect

the power and check if the resistance is over 5M between L,N
Utility source leakage
and G.
protection switch trips
2.Check if the instrument is short circuit inside.
3.If the problem persists, please contact your DL representative.

Remove the adapter plate and check the data line connection
The screen presents
between detection rack and the incubator.
communication failure.
If the problem persists, please contact your DL representative.

1.Remove the back cover and check the temperature controller

setting.
Incubation The screen presents 2.Check the solid relay of the temperature controller
and the temperature is 3.Check the heater circuit.
detection abnormal. 4.Check the temperature sensor connection.
module 5.Check the fan is running or not.
6.If the problem persists, please contact your DL representative.

1.Check if the temperature controller is broken down or not

The screen cannot
2.Remove the adapter plate and check the data line connection
present the data of
between detection rack and the incubator.
temperature.
3.If the parts are broken, please contact your DL representative.

1There may be no positive or negative bottles inside.

2.Check the door light circuit.
Door light out
3.Check the door light.
4.If the parts are broken, please contact your DL representative.

1.Check the door light circuit.

Door light gives
2.Check the door light communication line.
Light wrong color.
3.If the parts are broken, please contact your DL representative.

1Check if the communication lines between detection board

Cell detection light and incubation are loosened.
is not working 2.Check the detection lights
3.If the parts are broken, please contact your DL representative.

1. Use a new inoculated bottle to check the cell.

Cell indicator light 2. Check the cell indicator light.
is not working 3. Check the PCB board welding.
4. If the problem persists, please contact your DL representative.
20
 detection rack is not 1.Remove the back cover and check the motor.
moving while 2.Check the solid relay and the circuit of the motor.
incubating. 3.If the parts are broken, please contact your DL representative.

1.Check the circuit of braking of the motor;

detection rack won’t
2.Check the solid relay of the motor.
stop swinging all the
3.Check the position switch of the motor.
time.
4.If the parts are broken, please contact your DL representative.
Motor
The swinging speed Check the speed controller. It should be 8- 10 round/min. And
of the rack is use the hot-melt glue to fix the handle.
abnormal. If the problem persists, please contact your DL representative.

1.Check where the noise comes from.

Motor makes big 2.If from the rotation gear area, re-install rotation gear;
noise. 3.If the problem persists and noise comes from the motor,
please contact your DL representative.

The fan soundsweird Check the fan and clean it.

Fan
or is not working If the problem persists, please contact your DL representative.

1. (a)Switch the system OFF. (b)Wait 10 to 20 seconds.

(c)Switch power ON again.
Touch No display. 2.Check the electrical outlet and the power cord connection.
screen Turns all blank 3.Check all the wiring connected to the display.
4.If the problem persists, it might be the display internal
problem, please contact your DL representative.

Screen touch 1.Check the communication line between the display and main
function failure. board. Re-connect it if necessary.
Such as, the arrow 2.Calibrate the screen.
won’t follow the 3.If the problem persists, it might be the display internal
touch. problem, please contact your DL representative.

1.Check the connection.

Mouse and 2.Clean the mouse and keyboard with soft cloth..
Not working
keyboard 3.If the problem persists, it might be the display internal
problem, please contact your DL representative.

1.Check the connection with instrument. Re-connect it if

necessary.
Bar-code Unable to scan the
2.Clean the scanner with soft cloth.
scanner bar code.
3.If the problem persists, it might be the “reset barcode”
problem, please contact your DL representative.

21
 1.Give no report, if it
excesses maximum 1. Switch the system OFF.
incubation time. 2. Wait 10 to 20 seconds.
2.The system halted. 3. Switch power ON again.
3.Not showing bottle
number, after scanning If the problem persists, it might be the software problem. The
the barcode. software may need to be re-installed or upgraded. please
4Keep presenting contact your DL representative.
wrong warning.

1.Cell data reading

error. 1.Check if there was a bottle unloaded before.
2.No bottle in the cell. 2.(a)Switch the system OFF. (b)Wait 10 to 20 seconds.
But the cell still (c)Switch power ON again.
presents loaded.
3.When running the If the problem persists, it might be the software or the PCB
instrument,the screen board problem. The cell may need to be calibrated. please
Software
keeps warning there is contact your DL representative.
a bottle unloading.

Check the software setting if the sound is open.

The screen flashes light (a)Switch the system OFF. (b)Wait 10 to 20 seconds.
to report positive or (c)Switch power ON again.
negative. But no sound Check the buzzer.
warning. If the problem persists, it might be the buzzer problem. please
contact your DL representative.

1.Switch the system OFF.

2.Wait 10 to 20 seconds.
Dark screen, blur
3.Switch power ON again.
screen
If the problem persists, it might be the screen driver or main
board problem, please contact your DL representative.

Reconnect the lines which using the USB socket.

Use another mouse or scanner to check the USB socket.
USB The USB sockets are
Check the mainboard.
socket not working
If the problem persists, it might be the screen driver or main
board problem, please contact your DL representative.

22
6 After-Sales Service

6.1. Warranty explanation

1.If any failures, caused by material or manufacturing, happen within 1 month since the delivery
date, DL is responsible to replace it with a new instrument and take care of all the delivery expense.

2.If any failures, caused by material or manufacturing, happen within 12 months since the delivery
date, the manufacturer provides with free spare parts. Customers bear the cost of freight back to
repair department, while DL bear the freight charge of delivery back to customer.

3When the warranty is expired, DL only charges for favorable price of spare parts.

6.2. Warranty range

This warranty did not cover unexpected use, the use in the environment which does not meet the
requirements, and the damage from unauthorized repair or refit.

7 Delivery & Storage

7.1.The instrument is fixed tight in the carton, anti-rain, anti-moisture and anti-shock. During the
delivery, it is not allowed to shake fiercely and collide, which may seriously damage the instrument.

7.2. If the instrument is not used for a long period of time, it should be packed, anti-rain,
anti-moisture and anti-shock. And it should be stored at the temperature - 10℃~40℃, in the
ventilated indoor with relative humidity≤80% and no corrosive gases.

Model REF No.

BT24 1503080007

BT48 1503080008

BT60 1503080009

BT120 1503080010

BT180 1503080011

BT240 1503080012

23
 Manufacturing Enterprise
Company Name: Zhuhai DL Biotech Co., Ltd.
Address: 19 Jinhaian Rd, Sanzao Town, Jinwan, Zhuhai, Guangdong, 519041, P.R.China
Tel86-756-6292028 Fax86-756-3391389
Websitewww.medicaldl.com E-maildl@medicaldl.com

Shanghai International Holding Corp. GmbH (Europe)

Eiffestrasse 80, 20537 Hamburg Germany
Tel: +49-40-2513175 Fax:+49-40-255726
Dimid No.:DE/0000040627 E-mail: shholding@hotmail.com
Version: Oct.31.2022