Molbio Trueprep AUTO v2 Manuale utente

True AUTO prep v2

User Manual

603042001

REF

IVD

Universal Cartridge Based

Sample Prep Device

Trueprep AUTO v2

TABLE OF CONTENTS

Table of Contents

Table of Figures

1 Introduction 3

2 Installation 4

2.1 Installation Precautions 4

2.2 Environmental Requirements 4

3 Specifications 4

4 Precautions 4

5 Materials Required 5

5.1 Contents 5

5.2 Materials Required but not provided with device 5

6 The Trueprep AUTO v2 5

6.1 A Top Panel View 5

6.1B Back Panel View 6

6.2 The Cartridge 6

7 Using the Trueprep AUTO v2 7

7.1 Charging/Using the Trueprep AUTO v2 with the AC Adapter 7

7.2 Plugging in the reagent bottles 8

7.3 Switching ON/OFF the Trueprep AUTO v2 11

7.4 Placing the Cartridge in the device and starting the run 11

8 Errors, Alerts and Maintenance 14

8.1 Error Messages 14

8.2 User Menu 17

8.3 Maintenance 19

Trueprep AUTO v2

TABLE OF FIGURES

Trueprep AUTO v2

Figure 1: TheTrueprep AUTO v2 Top View, with cartridge holder 5

shown in the front panel

Figure 2: The Trueprep AUTO v2 device Back Panel with Reagent Pack of the 6

Trueprep AUTO v2 Universal Cartridge Based Sample Prep Kit

Figure 3: Disposable Trueprep AUTO v2 cartridge for sample processing 6

Figure 4: Low battery LED glowing red 7

Figure 5: The Charging Port in right hand side of the 8

Back Panel of the Trueprep AUTO v2

Figure 6: The Blue Charging LED Indicator Glowing 8

Figure 7:

Figure 8:

Figure 9: Reagent Reset Card for 50Tests Pack size 10

Figure 10: The cartridge holder opened after eject button is pressed 11

Figure 11: Cartridge being placed in cartridge holder 12

Figure 12: Cartridge placed in cartridge holder in correct orientation 12

Figure 13: Replaceable tray in cartridge holder 13

Figure 14: Removal of Replaceable Tray from cartridge holder 13

Figure 15: Replacement of discarded Replaceable tray with new 14

The Trueprep AUTO v2 Back Panel, with tubing and caps for plugging in

reagent bottles from the Reagent Pack of 25T pack size of the Trueprep

AUTO Universal Cartridge Based Sample Prep Kit

The Trueprep AUTO v2 device Back Panel with Reagent Pack (50T) of

the Trueprep AUTO v2 Universal Cartridge Based Sample Prep Kit

1. Introduction

1.1 The Trueprep AUTO v2 Universal Cartridge Based Sample Prep Device

Testing for infectious diseases by detecting the pathogens nucleic acids using nucleic acid

amplification methods is a highly specific and sensitive diagnostic tool. Molbio's Truelab micro

PCR System is a nucleic acid amplification platform that works on Real Time Polymerase Chain

Reaction (PCR) technology that enables near patient diagnosis through disposable, disease

specific micro PCR chips and a portable, automated Truelab Real Time micro PCR analyzer.

The PCR process necessitates the extraction and purification of nucleic acids from clinical

specimens to free it from potential PCR inhibitors. The Trueprep AUTO v2 Universal

Cartridge Based Sample Prep Device together with Trueprep AUTO v2 Universal Cartridge

Based Sample Prep Kit provides an easy method of nucleic acid extraction and purification.

Trueprep AUTO v2 Universal Cartridge Based Sample Prep Device is light weight and

portable and operates on mains and/or re-chargeable battery. It is capable of performing upto 16

sample extractions with one recharge and is fully automatic, with minimal hands on time.

The cartridge based extraction process is quick, reliable, and efficient and does not require

highly skilled personnel to carry out the extraction process. All the waste from processing of the

sample is contained within the cartridge dump area thus posing no risk from potentially bio-

hazardous material.

The device has a universal protocol and can work with all kinds of samples such as sputum, BAL,

whole blood, serum, plasma, tissue, stool, urine, CSF, pleural fluid, lymph node aspirate, pus,

peritoneal fluid, saliva, swab specimens and culture specimen.

1.2 Principle

The Trueprep AUTO v2 is an electromechanical system pre-programmed to sequentially heat,

mix and add reagents to the contents of the cartridge placed in the cartridge holder and has a

2 - line LCD screen that displays the status.

Specimen pre-treated with lysis reagent is added to the sample chamber of the cartridge which is

then placed in the cartridge holder of the device. Sample processing is initiated upon pressing

the start button on the device, through an automatic pre-programmed process wherein nucleic

acids released by chemical and thermal lysis of cells bind to the proprietary matrix in the matrix

chamber. In subsequent steps, the captured nucleic acids are washed with buffers to remove the

PCR inhibitors and finally eluted from the matrix using the elution buffer. At the end the cartridge

is automatically ejected and the elute containing purified nucleic acids is then collected from the

elute chamber for further analysis.

Trueprep AUTO v2

2 Installation

2.1 Installation Precautions

 Do not install the Trueprep AUTO v2 next to instruments that may cause

vibrations or electromagnetic interference.

 Do not store the Trueprep AUTO v2 in the path of direct sunlight or use it close to any

radiating or heating apparatus, such as a conventional oven, hot plate or infrared lamp.

 Do not store the Trueprep AUTO v2 in an atmosphere of potentially explosive liquids,

vapors and gas.

 Always place the Trueprep AUTO v2 on a flat surface in an upright position.

2.2 Environmental Requirement

The Trueprep AUTO v2 has been designed to operate safely within the following environment

specifications:

 Room temperatures ( between 15°C to 45°C )

 Relative Humidity (RH) between 10% –90% (non-condensing)

 The unit should be stored on a flat, dry surface.

3 Specifications

“ AUTO v2 complies with the emission and immunity requirements described in IEC 61326

Trueprep

series”.

4 Precautions

 Check for Low Battery before using the Trueprep AUTO v2 (see section 7.1)

 Insert and remove the cartridge gently from the holder, use of excessive force could damage

it.

 Do not spill liquids inside the cartridge holder

 Do not perform an extraction in the presence of reactive vapours (e.g., from sodium

hypochlorite, acids, alkalis or aldehydes) or dust.

Proprietary matrix-based extraction

Fully Automatic

2 line alphanumeric LCD

Rechargeable Lithium Ion Battery Pack 7.4 V, 8.7 Ah

External AC/DC adaptor: Input 1.5A, 100/240V, 50/60 Hz;

Output 10V, 4.5A

2.75 kgs

215 x 235 x 115 mm

Proprietary firmware

Temperature 15 - 45°C, RH: 10 -90%

Principle

Operation

Display Screen

Power

Weight

Size

Software

Operating environment

Trueprep AUTO v2 Device

Trueprep AUTO v2

5 Materials Required

5.1 Contents

 Trueprep AUTO v2 Universal Cartridge Based Sample Prep Device (REF603042001)

 AC Adapter (SMPS) with power cord to power -1No.

 Trueprep (REF603090001)- 25 Nos. Replaceable tray for cartridge holder

 Trueprep (REF603100001) - 1No. Cartridge Stand

 Trueprep Reagent Pack holder (REF603160001) - 1No.

 Trueprep AUTO v2 Plug-in connector for 25T Reagent Bottle Pack/Flush

(REF604090001) - 1No.

 User Manual -1No.

5.2 Materials Required but not provided with Device

Trueprep AUTO v2 Universal Cartridge Based Sample Prep Device compatible with :

Trueprep AUTO/AUTO v2 Universal Cartridge Based Sample Prep Kit (REF60203AR25/

REF60207AR50) consisting of

 Universal Reagent Pack (25/50 tests)

 Universal Cartridge Pack (25/50 Nos.)

 Disposable transfer pipette graduated (25x3ml/50x3ml)

 Package insert (1 No.)

6. The Trueprep AUTO v2

6.1A Top Panel View

Figure 1 : The Trueprep AUTO v2 Top View, with cartridge holder shown in the front panel

 The Power button switches on and switches off the Trueprep AUTO v2

 The Eject button opens the cartridge holder

 The Start button is used to begin sample processing

5®

CHARGING /LOW

BATTERY LED

Indicator

POWER button

START button

POWER/IN USE

LED Indicator

EJECT button

Cartridge Holder Door

Plugin Connector Reagent Pack

2 LINE Alphanumeric LCD

Trueprep AUTO v2

 The Power/In Use LED Indicator will glow when theTrueprep AUTO v2 is switched on and

when it is in use.

i) It will glow red and blink continuously when the Trueprep AUTO v2 is switched on and

waiting for user input

ii) It will glow red continuously when it is in use

 The Charging/Low Battery LED Indicator will glow when the Trueprep AUTO v2 battery is

low and when it is being charged using the power cable.

i) It will glow red when the battery is low and needs to be charged

ii) It will glow blue when the Trueprep AUTO v2 is being charged

6.1B Back Panel View

Figure 2: The Trueprep AUTO v2 device Back Panel with Reagent Pack of

the Trueprep AUTO v2 Universal Cartridge Based Sample Prep Kit

6.2 The Cartridge

Samples are processed on disposable, single-use cartridges that are inserted into the cartridge

holder. These cartridges come pre-loaded with Internal Positive Control and only require the

addition of pre-treated sample to the sample chamber for processing on the Trueprep AUTO

v2.

Figure 3: Disposable Trueprep AUTO v2 cartridge for sample processing

6®

Trueprep AUTO v2

Matrix Chamber

Sample chamber Rotary Valve

QR Code

Elute chamber

Cap

VER-01

7 Using the Trueprep AUTO v2

7.1 Charging/Using the Trueprep AUTO v2 with the AC Adapter

7.1.1 Press the Power button to switch on the Trueprep AUTO v2

7.1.2 Low battery

 If the battery charge is low, you will see the above alert message

 The Charging/Low Battery LED Indicator will glow red and you will also hear a beeping

sound. The Trueprep AUTO v2 device can not begin a new run if the battery is low.

Fig 4: Low battery LED glowing red

7.1.3 If the battery charge is full or sufficient to carry out a run, the Charging/Low Battery LED Indicator

will stay off. You may proceed to use Trueprep AUTO v2 on battery charge.

For charging or to use Trueprep AUTO v2 on mains, connect the AC Adapter to the Charging

Port on the right side of the back panel of the device.

BATTERY LOW !

CONNECT CHARGER

Trueprep AUTO v2

Figure 5: The Charging Port in right hand side of the Back Panel of the Trueprep AUTO v2

7.1.4 Connect the other end of the AC Adapter to a mains socket.

7.1.5 Switch On the mains power.

® ®

7.1.6 You can now proceed to use the Trueprep AUTO v2 using the mains power. If the Trueprep

AUTO v2 is being charged, the charging LED Indicator will glow blue. Charging takes ~3-4

hours (overnight). When charging is complete, the charging LED Indicator will go off. When this

happens, please disconnect the AC Adapter unless it is being used to power the device.

Figure 6: The Blue Charging LED Indicator Glowing

7.2 Plugging in the Reagent Bottle Pack of 25 T or Reagent Pack of 50T

7.2.1 Plugging in the Reagent Bottle Pack of 25 T packsize:

1. Before starting a run for the first time, plug in the colour coded reagent bottles from the Trueprep

AUTO Sample Prep Kit Reagent Pack into the back panel of the device, matching the colour of

the cap on the panel with the colour of the reagent bottle cap in the kit using provided Plug-in

connector with coloured caps (Figure 7). Discard the reagent bottle cap once the bottle is

plugged in.

2. Ensure that the tubing is fully immersed in the liquid upto the bottom of the reagent bottle.

Trueprep AUTO v2

3. A set of bottles is sufficient for 25 tests.

4. The device will prompt when 25 tests have been completed and the bottles have to be replaced

by following manual buffer resetting procedure as per Point No. 7.2.5.1.

Figure 7: The Trueprep AUTO v2 Back Panel, with tubing and caps for plugging in reagent bottles

from the Reagent Pack of 25T pack size of the Trueprep AUTO Universal Cartridge Based Sample Prep Kit

7.2.2 Plugging in the reagent pack of 50T pack size:

1. Before starting a run for the first time, plug in the reagent pack from the Trueprep AUTO v2

Sample Prep Kit to the backside of the device (Figure 8). Discard the used reagent pack in a

proper manner.

2. The device will prompt when 50 tests have been completed and the reagent pack have to be

replaced by following buffer resetting procedure as per Point No. 7.2.5.1 or 7.2.5.2.

Figure 8: The Trueprep AUTO v2 device Back Panel with Reagent Pack (50T) of

the Trueprep AUTO v2 Universal Cartridge Based Sample Prep Kit

Trueprep AUTO v2

Plug-in connector

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