DL-

USER MANUAL DL-96A

FULLY AUTO MICROBIAL IDENTIFICATION AND
ANTIMICROBIAL SUSCEPTIBILITY TESTING 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 license 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 Province, 519041, P.R. China
Website: https://en.medicaldl.com/
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

2 Understanding The Instrument 02

2.1 Instrument Name & Model No. 02

2.2 Principles, Properties & Uses 02

3 Instrument Assembly 03

3.1 Instrument Assembly 03

3.2 Schematic Illustration of the Structure 04

3.3 Installation 05

3.4 Load the Auxiliary reagent 05

4 Understanding The System 06

4.1 Operational Instruction 06

5 Management And Maintenance 25

5.1 Maintenance 25

6 After-Sales Service 26

6.1 After-sale service 26

7 Delivery & Storage 27

7.1 Unpacking & Inspection 27

7.2 Delivery & Storage 27

1 About This Manual

1.1 Introduction

This chapter explains how to use your DL-96A user manual. This chapter explains how to use your
use manual, which is shipped with your Microbial Identification and Antimicrobial Susceptibility
Testing System and contains reference information about the DL-96A and procedures for operating,
troubleshooting and maintaining the analyzer. Read this manual carefully before operating your
DL-96A analyzer and operate your DL-96A 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 DL-96A.

2.Customized 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 microbial sample in the test card, please wear medical gloves.
Used test cards should be disposed as medical waste appropriately for
External of the sake of avoiding potentially bio-hazardous 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.

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 Protective earth (ground)

For in vitro diagnostic use

1.5 Symbols used in the label

Manufacturer Date of manufacture

Authorized representative Keep away from sunlight

Lot number Serial number

Keep away from rain Fragile, handle with care

Read the instruction before use

2 Understanding The Instrument

2.1 Instrument Name & Model No.

Instrument NameFully Auto Microbial ID/AST Testing System

Model No.DL-96A

2.2 Principles, Properties & Uses

Principles

DL-96A is used for identifying isolated bacteria and fungus and determinate its minimum inhibitory
concentration(MIC) to different drugs. DL-96A contains a set of incubation area, heating device,
detection device and embedded control device. DL-96A detects and analyzes the specimen in test
card by colorimetry and turibidimetry, and automatically generate the results of bacterial species
identification and antimicrobial result with MIC value.

Working condition

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 Ambient Temp.: 5-30℃

Relative humidity≤80%

Atmospheric pressure76KPa-106KPa

Power supplyAC100-240V, 50/60Hz, 1100VA

Illumination: Avoid direct sunlight.

Performance

Indentification capabilities: DL-96A can identify microbes as "Species" and even "Subspecies",
and it covers nearly 200 types of antibiotics with multi-level concentration, up to 7-dilution for
giving TRUEMIC value.

Plate reading time: ≥50 pcs/hr

Capacity: 60 cards

Application

The product is used for the identification of clinical pathogens and semi-quantitative analysis of
antimicrobial drugs MIC. The following test cards can be used by the instrument.

IST card (Model: DL-96E, DL-96NE, DL-96STAPH, DL-96STREP, DL-96FUNGUS)

Enterobact. IST CARD (Model: DL-120E, DL-120E AST, DL-120E II)

Non-ferment. IST CARD (Model: DL-120NE, DL-120NE AST, DL-120NE II)

Staph. IST CARD (Model: DL-120STAEP, DL-120STAPH AST, DL-120STAPH II)

Strep. IST CARD (Model: DL-120STREP, DL-120STREP AST, DL-120STREP II)

Corynebacterium ID/AST Test Card (Model: DL-120CORYNE)

Neisseria / Hemophilus ID/AST kit (Model: DL-120NH)

Anaerobe ID/AST Test Card (Colorimetry&Turbidimetry) (Model: DL-96ANA)

3 Instrument Assembly

3.1 Instrument Assembly

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 The Microbial ID/AST analyzer must be placed on a flat, solid working table.

3.1 Circuit wiring

The Microbial ID/AST analyzer is wired according to its sketch

Before replace insurance tube inside fuse, please insure that system and power supply are closed.
Fuse Type code: F5AL250V.

3.2 Schematic Illustration of the Structure

Instrument size880mm x 635mm x 878mm

Package size 945mm x 700mm x 1080mm

Weight135KG(N.W) 156KG(G.W)

Product schematic diagram

6
1

2 5
4

3
Front view

1 Test card incubation area 2 Display FANS 3 Keyboard Power socket 4 Power

5 Recycle Bin 6 Auxiliary reagent 7 Upper cover

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 1
2

Rear view

1 FANS 2 Power socket

Standard Configuration
SN Description Quantity
1 Main Unit 1
2 Power Supply 1
3 Mouse 1
4 Keyboard 1
5 User Manual 1
6 Packing List 1
7 Quality certificate 1
8 wild-mouth bottle 8
9 Tip 8

3.3 Installation

Place the instrument on a stable flat surface, connect the mouse and keyboard to it

keep it more than 20cm away from the wall or other obstacles;

According to working condition, connect the power supply.

3.4 Load the Auxiliary reagent

Open the door on the upper right part of the instrument, then pull out the auxiliary reagent holder.

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Add the auxiliary reagents to corresponding bottles.,,

Insert the holder with the reagent back to the right position and close the door.

4 Understanding The System

4.1 Operational Instruction

Edit the hospital name:

1. open the file “SystemInfo.ini”

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2.Input the hospital name behind “Hospital=”.

4.1.1 System Login

Double clicks the icon , the screen will display as following

Enter the user name and password. Please notice: Initial user name is “DL”, initial password is “1”.
Then click < Sign in > , the screen will display as following:

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4.1.2 Detection

4.1.2.1 Absence of Microorganism

After isolating and culturing the specimens, if there is no microorganism, it reports absence of
microorganism. Click “No microbe report”, then fill all the contents. Finally, click “View report ”.
(Attention: Report of absence of microorganism should be printed by A5 paper)

4.1.2.2 Presence of Microorganism

After isolating the specimens, if there is microbial growth, inoculate the microorganism in test card
in accordance with DL operational instruction of test card. Then follow the operation as blew.

4.1.2.3 Put the test card inside the system

Click “Monitor”,the screen will display as following:

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Open the incubator door, put the test card into the empty position(Bar code outward) as below
shows.

Then the icon will turn to “Incubating” , if one line was full, click another line icon and
the turntable will turn to next one, close the door until all the test card are put inside.

4.1.3.4 Scan the Bar code

When closing the door, the instrument will scan the barcode automatically inside and create a
reading task. Then the test cards are in the incubating status.

4.1.3.5 Input new data

Back from “Monitor”, and input the data of the test and patient, like specimen code, patient name
and so on. Especially the one with mark *, like test purpose, specimen type, ward, must be input.

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Notice:

1) the specimen code can’t be reused.

2) “ ” shall be input for midstream urine sample only.

3)In the bottom line, “Load” means the quantity of loaded test cards; “Reading” means the quantity
of test cards under reading; “Incubating” means the quantity of test cards under incubation; “ Finish”
means the quantity of test cards that are finished reading; “Abnormal” means the quantity of test
cards that are having issues.

4.1.2.6 Test card reading

The system will read the test card automatically, when the “Status” of the specimen list show
“Finish”, it means that the test card was finished incubation and result reading.

4.1.2.7 The Result of Microbial ID/AST

Click “Test Card” to show the result of test card, as the following shows:

Click “Drug sensitivity” to show the result of drug sensitivity, as the following shows:

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Note: If the status is Reading, it means the system is reading the test card. If the status is incubating,
it means the test card is under incubation. If the status is analyzing, it means the test card is being
analyzed. If the status is incomplete, it means the specimen information should be filled completely.
If the status is abnormal, please check the issue.

Right click the drug to select whether to show the drug in final report.

Click “Supplement sensitivity” to add other drug sensitivity results to the report,

as the following shows:

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Click”Remark” to add notes in the report, as the following shows:

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Then click “View report” to see the report like following:

Technician can print the report if needed. And click “Close” to back to main menu.

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4.1.3 Search the reports

Click “ ” to the below screen

4.1.3.1 View old reports

And click “Sort by” to select the search condition and click “Search” to find the targeted reports.,
as below shows:

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4.1.3.2 Modify reports

Choose the report that is required to modify, and click “ Revocate review”:

Then, click “ ”to modify the report.

Note: Only the administrator has the authority to modify old reports.

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4.1.3.3 Delete

Select the targeted specimen number and click “ ” and enter the password.

Note: Only the administrator has the authority to delete old report.

4.1.4 Statistic

Click “ ” to reach the following page:

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And click “ Workload statistics”, it shows the function of statistic of workload by selecting different
aspects.

Click “Statistics of detected microbe” , it shows statistics function of detected microbe.

Click “Microbial susceptibility statistics”, and it shows statistics function of susceptibility result.

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Click “Customized statistics”, and it shows statistics function that it can be sorted by different
aspects.

DL-96A can export data to WHONET by generating a dbf file. Click “Export report data” and
choose the time length and click “export” , as the following page:

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Click “Statistical setting” to set the object and definition of the strain.

4.1.5 Setting

Click “ ” as below shows:

And give authorization to different users.

Note: Only the administrator has the authority to change the setting.

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Click “Sample information definition” to add the items of test purpose, ward, sample type and no
microbe report.

Click “Shortcut code setting” to set the shortcut of the different data for WHONET.

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Click “WHONET configuration” to set the WHONET data.

Click “Data export and backup setting” to backup data by sending the data to certain location, and
export the data.

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Click “About the software” check the version of the software and the copyright information.

4.1.5 Quality Control

Click “ ” for quality control, as the following page:

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Insert the QC test card, and input the lot number of the test card, select the “Product name” and
“QC strains”, then click “ ”, and wait for the incubation and detection to be completed.
Click the QC sample, the result will show up.

If the result shows “ Not pass”, click “Analysis of losing control” to find out the reason. If the result
shows all pass, click “Preview report to gain the QC report like following:

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4.2 Precautions

1.Please read this instruction before using the instrument.

2.The instrument must be placed on fixed flat table in well-ventilated room, and avoid direct
sunlight.

3.Power supply must be AC100V-240V, 50/60Hz and remain grounded. Do not place the instrument
on bad place that is difficult to disconnect the power supply.

4.Keep the instrument from being spilled by reagent liquid and other liquids to avoid contamination
and corrosion.

5.If no test card is placed on the instrument tray, don’t operate detection.

6.After the use of instrument, it should be wiped clean. Abrasive cleaners are not allowed.

7.After turning off the power, use a piece soft cloth or other covers to prevent dust from entering
the instrument.

8.Regard inoculated test cards as contagious sources, operators must wear protective gloves or take
other protective measures when operating. After identification, disinfect the test card before
throwing it away.

9.Contraindications: None.

10.If you do not use the instrument in accordance with its instruction, the protection provided by
the equipment may be damaged.

5 Management And Maintenance

5.1 Maintenance

5.1.1 Regularly use clean soft cloth to wipe the instrument with a small amount of pure water. If the
surface of the instrument has stains, use a clean soft cloth moistened with cleaning paste to clean it.

5.1.2 If the instrument is not used for a long time, use a piece soft cloth or other covers to prevent
dust from entering the instrument. And regularly maintain it.

5.1.3 DL-96A is a complex precision instrument. During the use, some errors happen and need to
be calibrated. Its calibration must be calibrated by professional engineers of the manufacturer.

5.1.4 When used for a long time, the auxiliary reagent tip may be deformed or blocked, and the tip
needs to be replaced.

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Open the tip buckle, then take away the old tip and replace the new one on the right position, then
close the buckle.

6 After-Sales Service

6.1 After-sale service

6.1.1 Warranty explanation

6.1.1.1 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.

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

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

6.1.2 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.

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7 Delivery & Storage

7.1 Unpacking & Inspection

7.1.1 Please follow the signs on the carton to take out the instrument, when unpack it. Don’t smash
it to avoid damage to the instrument.

7.1.2 Please follow the product list to inspect the instrument and fittings. If any omission, please
contact the supplier immediately.

7.2 Delivery & Storage

7.2.1 The instrument is fixed tightly 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 product.

7.2.2 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. And the instrument use life
is 10 years.

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 1502040005

Manufacturing Enterprise
Company Name: Zhuhai DL Biotech Co., Ltd.
Address: 19 Jinhaian Rd, Sanzao Town, Jinwan, Zhuhai, Guangdong Province, 519041, P.R. China
Websitehttps://en.medicaldl.com/ [email protected]

Shanghai International Holding Corp. GmbH (Europe)

Eiffestrasse 80, 20537 HamburgGermany
Tel: +49-40-2513175 Fax:+49-40-255726
Dimid No.:DE/0000040627 E-mail: [email protected]
Version: Jul 12, 2023