Molbio Trueprep AUTO v2 User manual

True AUTO prep v2
User Manual
603042001
REF
IVD
Universal Cartridge Based
Sample Prep Device
®
Trueprep AUTO v2
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1
TABLE OF CONTENTS
Table of Contents
Table of Figures
1
2
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
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7 Using the Trueprep AUTO v2 7
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7.1 Charging/Using the Trueprep AUTO v2 with the AC Adapter 7
7.2 Plugging in the reagent bottles 8
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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
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Trueprep AUTO v2
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2
TABLE OF FIGURES
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Trueprep AUTO v2
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Figure 1: TheTrueprep AUTO v2 Top View, with cartridge holder 5
shown in the front panel
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Figure 2: The Trueprep AUTO v2 device Back Panel with Reagent Pack of the 6
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Trueprep AUTO v2 Universal Cartridge Based Sample Prep Kit
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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
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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
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The Trueprep AUTO v2 Back Panel, with tubing and caps for plugging in
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reagent bottles from the Reagent Pack of 25T pack size of the Trueprep
AUTO Universal Cartridge Based Sample Prep Kit
9
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The Trueprep AUTO v2 device Back Panel with Reagent Pack (50T) of
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the Trueprep AUTO v2 Universal Cartridge Based Sample Prep Kit
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3
1. Introduction
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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
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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
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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
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specimens to free it from potential PCR inhibitors. The Trueprep AUTO v2 Universal
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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.
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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
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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.
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Trueprep AUTO v2

4
2 Installation
2.1 Installation Precautions
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 Do not install the Trueprep AUTO v2 next to instruments that may cause
vibrations or electromagnetic interference.
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 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.
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 Do not store the Trueprep AUTO v2 in an atmosphere of potentially explosive liquids,
vapors and gas.
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 Always place the Trueprep AUTO v2 on a flat surface in an upright position.
2.2 Environmental Requirement
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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
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Trueprep
series”.
4 Precautions
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 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
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Trueprep AUTO v2 Device
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Trueprep AUTO v2

5 Materials Required
5.1 Contents
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 Trueprep AUTO v2 Universal Cartridge Based Sample Prep Device (REF603042001)
 AC Adapter (SMPS) with power cord to power -1No.
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 Trueprep (REF603090001)- 25 Nos. Replaceable tray for cartridge holder
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 Trueprep (REF603100001) - 1No. Cartridge Stand
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 Trueprep Reagent Pack holder (REF603160001) - 1No.
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 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
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Trueprep AUTO v2 Universal Cartridge Based Sample Prep Device compatible with :
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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.)
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6. The Trueprep AUTO v2
6.1A Top Panel View
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Figure 1 : The Trueprep AUTO v2 Top View, with cartridge holder shown in the front panel
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 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
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v2
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Trueprep AUTO v2

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 The Power/In Use LED Indicator will glow when theTrueprep AUTO v2 is switched on and
when it is in use.
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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
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 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
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ii) It will glow blue when the Trueprep AUTO v2 is being charged
6.1B Back Panel View
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Figure 2: The Trueprep AUTO v2 device Back Panel with Reagent Pack of
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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
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addition of pre-treated sample to the sample chamber for processing on the Trueprep AUTO
v2.
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Figure 3: Disposable Trueprep AUTO v2 cartridge for sample processing
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Trueprep AUTO v2
Matrix Chamber
Sample chamber Rotary Valve
QR Code
Elute chamber
Cap
VER-01

7
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7 Using the Trueprep AUTO v2
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7.1 Charging/Using the Trueprep AUTO v2 with the AC Adapter
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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
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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
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will stay off. You may proceed to use Trueprep AUTO v2 on battery charge.
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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
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Trueprep AUTO v2

8
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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.
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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:
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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.
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Trueprep AUTO v2

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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.
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Figure 7: The Trueprep AUTO v2 Back Panel, with tubing and caps for plugging in reagent bottles
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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:
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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.
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Figure 8: The Trueprep AUTO v2 device Back Panel with Reagent Pack (50T) of
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the Trueprep AUTO v2 Universal Cartridge Based Sample Prep Kit
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Trueprep AUTO v2
Plug-in connector

10
7.2.5 Buffer Resetting Procedure
When buffer count is completed (buffer count=25/50), the device will prompt for changing Reagent
pack and resetting buffer count.
7.2.5.1 When QR code scanning disabled:
Following will be displayed on screen alternatively, once buffer count reaches 25/50.
Press Start and Eject button together, buffer count will reset to zero and following will be displayed.
7.2.5.2 When QR code scanning enabled:
Following will be displayed on screen alternatively, once buffer count reaches 50.
Press Eject, insert Reagent Reset Card provided with the new Reagent pack, close the tray and
press start. Once the buffer count has reset to zero, following will be displayed on screen.
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BY PRESSING START
& EJECT SW
SHUTTING DOWNCHANGE REAGENT
PACK & RESET
SHUTTING DOWNSETTINGS SAVED
SHUTTING DOWN
INSERT REAGENT RESET
CARD & START
SHUTTING DOWN
NEW REAGENT PACK
CHANGE REAGENT
PACK
Figure 9: Reagent Reset Card for 50 Tests pack size
Reagent Reset Card
(This side towards the device)
Universal Cartridge Based Sample Prep Kit
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50
FIFTY TESTS
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v2
Lot No.:
Mfg. Dt.:
Exp. Dt.:
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Trueprep AUTO v2

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7.3 Switching ON/OFF the Trueprep AUTO v2
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7.3.1 Press the Power button to switch on the Trueprep AUTO v2. You will be prompted with the
message ‘Buffer Count’.
.
7.3.2 Later you will be prompted with the message for
7.3.3 Press the Power button, when following screen will be displayed, release the power button.
The device will turn off automatically within 30 seconds.
7.4 Placing the Cartridge in the device and starting the run
Important: Only use the cartridge provided in the corresponding sample prep kits.
7.4.1 Press the Eject button to open the cartridge holder. You will be prompted with the message
11
TRUEPREP AUTO
BUFFER COUNT
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SHUTTING DOWN
INSERT CARTRIDGE
Figure 10: The cartridge holder opened after eject button is pressed
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Trueprep AUTO v2

12
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7.4.2 Take a cartridge out of the Cartridge Pouch from the Trueprep AUTO v2 Universal Cartridge
Based Sample Prep Kit Cartridge pack. The pouch also contains one Elute Collection Tube (ECT) for
use at the end of extraction. Place the cartridge, after adding pre-treated sample (sample + lysis
reagent) into the sample chamber (see procedure in corresponding Truenat™ pack insert), in the
cartridge holder. Note the orientation of the cartridge is to be placed in picture below.
Caution: Placing the cartridge in the wrong orientation will cause the cartridge holder to remain
open, and the cartridge will not be inserted in the device
Figure 11: Cartridge being placed in cartridge holder
7.4.3 Push the cartridge holder gently inwards to close it shut. Press the Start Button to proceed.
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This is the start of the Trueprep AUTO v2 sample preparation process. After reading the QR
code of Cartridge Extraction process starts. If the QR code is read then the same cartridge
cannot be reused. The reagents from the bottle/pouch in the back will be automatically added to
the cartridge based on the pre-programmed protocol.
Figure 12: Cartridge placed in cartridge holder in correct orientation
7.4.4 Once the process is completed the device will give a beep sound with display message as below
COLLECT ELUTE
---COMPLETED---
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Trueprep AUTO v2

The device will automatically eject the cartridge holder. Take out the cartridge and place it on the
cartridge stand. Pierce the seal of elute chamber and aspirate out the entire elute into Elute collection
tube (ECT) using Disposable transfer pipette provided in the cartridge pack.
7.4.5 Discard the cartridge as per the instructions in Section 8.3.
7.4.6 Tray replacement
Cartridge holder contains one middle tray as shown in Figure 13. Steps for replacement of Replaceable
Replaceable tray are as follows:
Step 1: Removal of the tray:
Remove the tray from cartridge holder as shown in the Figure 14. Replaceable
Step 2: Placement of the tray:
2a. Place the tray in cartridge holder as shown in Figure 15. Replaceable
i. Inspect the tray in the cartridge holderReplaceable
ii. If there are liquids spilled in the tray, take out the tray and discard as per the instructions in
Section 8.3.
iii. Clean the cartridge holder with 70% Isopropyl Alcohol (IPA) as described in Section 8.3.
iv. Replace the removed tray with a new tray and close the cartridge holder (25 Replaceable
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trays are provided with the Trueprep AUTO v2 device. More trays, if required, can be
ordered from Molbio).
3 Replaceable Figure 1 : tray in cartridge holder
Figure 14: Removal of Replaceable Tray from cartridge holder
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Replaceable Tray
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Trueprep AUTO v2

14
Figure 15: Replacement of discarded tray with new Replaceable
8 Errors, Alerts and Maintenance
8.1 Error Messages
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Trueprep AUTO v2
E2
E3
E1 Cartridge Errors
Error
Code Display message ErrorType Description
The Screen displays the error message
“E1:CARTRIDGE VALVE ERROR” and
instruction “Press Eject to exit” alternatively.
Solution:
Contact Molbio’s support team
E1:CARTRIDGE
VALVE ERROR
Press Eject
to exit
E2:CARTRIDGE
ERROR
The Screen displays the error message
“E2:CARTRIDGE ERROR” and instruction
“Press Eject to exit” alternatively.
Solution:
Contact Molbio’s support team
The Screen displays the error message
“E3:CARTRIDGE CLOGGED ” and
instruction “Press Eject to exit” alternatively.
Solution:
Contact Molbio’s support team
Press Eject
to exit
E3:CARTRIDGE
CLOGGED
Press Eject
to exit

15 ®
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Trueprep AUTO v2
E4 Cartridge Errors
Error
Code Display message ErrorType Description
The Screen displays the error message
“E4:USED CARTRIDGE” and instruction
“Press Eject to exit” alternatively.
Solution:
Use new cartridge
E4: USED
CARTRIDGE
Press Eject
to exit
E5
E6
E5:EXPIRED
CARTRIDGE
The Screen displays the error message
“E 5 : E X P IR E D CA R T R ID G E ” a n d
instruction “Press Eject to exit” alternatively.
Solution:
Check the Expiry Date of cartridge
The Screen displays the error message
“E6:CARTRIDGE NOT LOADED” and
instruction “Press Eject to exit” alternatively.
Solution:
Contact Molbio’s support team
Press Eject
to exit
E6:CARTRIDGE
NOT LOADED
Press Eject
to exit
Reagent Pack
Errors and
Warnings
E7
E8
E7:EXPIRED
RESET CARD
The Screen displays the error message
“E7:EXPIRED RESET CARD” and
instruction “Press Eject to exit” alternatively.
Solution:
Check the Expiry Date
The Screen displays the error message
“E8:USED RESET CARD” and instruction
“Press Eject to exit” alternatively.
Solution:
Use new Reset card
Press Eject
to exit
E8: USED
RESET CARD
Press Eject
to exit

16 ®
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Trueprep AUTO v2
E9
Error
Code Display message ErrorType Description
The Screen displays the error message
“E9: RESET CARD READ ERROR” and
instruction “Press Eject to exit” alternatively.
Solution:
Contact Molbio’s support team
RESET CARD
READ ERROR
Press Eject
to exit
E10
W1
E10: INVALID
RESET CARD
The Screen displays the error message
“E10:INVALID RESET CARD” and
instruction “Press Eject to exit” alternatively.
Solution:
Contact Molbio’s support team
The Screen displays the alert message
“W1:SBC NOT RESPONDING” for 2
seconds.
Solution: Contact Molbio’s support team
Press Eject
to exit
W1:SBC
NOT Responding
Reagent Pack
Errors and
Warnings
E11 E11:RTD-
L ERROR
E12 The Screen displays the error message
“E12:RTD- E ERROR”
Note: This is for Elution Heater
E11:RTD-
E ERROR
Device
Errors and
warnings
E11
The Screen displays the error message
“E11:RTD-L ERROR”
Note: This is for Lysis Heater
Solution:
Contact Molbio’s support team
E11:RTD-
L ERROR
E12 The Screen displays the error message
“E12:RTD- E ERROR”
Note: This is for Elution Heater
Solution:
Contact Molbio’s support team
E12:RTD-
E ERROR
W2 The Screen displays the alert message
“W2:UNABLE TO READ CARTRIDGE” for
2 seconds
Solution:
Contact Molbio’s support team
W2:UNABLE TO
READ CARTRIDGE
W3 The Screen displays the alert message
“W3:BATTERY LOW! CONNECT
CHARGER” until charger is connected.
W3:BATTERY LOW !
CONNECT CHARGER

17 ®
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Trueprep AUTO v2
E13
Error
Code Display message ErrorType Description
The Screen displays the error message
“E13: SELF TEST FAILED” current base
pressure value and instruction “Press Eject
to exit” alternatively.
Solution: Check for any rubber stuck to the
Dump Nozzles (D1 & D2)
E13:SELF TEST
FAILED
BASE PRESSURE
p=x.xxx
Press Eject
to exit
Device
Errors and
warnings
8.2.1 Accessing Menu
®
ŸPress and hold ‘Start Button’ and ‘Power Button’ on the Trueprep AUTO v2. Firmware Version
and Total run status counts will be displayed on the screen as given below.
Ÿ Release both the buttons, when following is displayed.
ŸIn the menu, the first line of LCD display shows different function options. The second line displays
navigating options for next (>: Eject Button) and back (< : Start Button). The ‘Power Button’ allows
selection of currently displayed item.
8.2.2 Exiting User Menu
ŸNavigate to and select following item to exit from the menu.
8.2 User Menu
Firmware Ver: X.X
Buffer Count=X X
TC=X X X X EC = X X X X
LC=X X X X CC=X X X X
- MENU -

18 ®
Note: Shutdown is disabled in menu; in order to shutdown the device, user must exit from menu and press Power Button.
8.2.3 Flushing Procedure
ŸReplace Reagent Pack for 25T or 50T with Distilled water, using provided Plug-in connector.
ŸSelect “Flush” menu and once it is selected tray will be ejected. Following screens will toggle
with 2 seconds interval.
Ÿ Insert cartridge and press start, the flushing process will begin.
Ÿ The cartridge will be ejected once flushing is completed, following will be displayed on screen
and device will go back to menu.
Ÿ Press Power button to exit without flushing.
- EXIT-
< > OK
- EXIT-
< > OK
- EXIT-
< > OK
CONNECT
DISTILLED WATER
®
Trueprep AUTO v2
- EXIT-
< > OK
INSERT CARTRIDGE
AND PRESS START
- EXIT-
< > OK
FLUSH COMPLETED

19 ®
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Trueprep AUTO v2
8.3 Maintenance
8.3.1 Disposal of consumables
Discard the used cartridges, trays, reagent bottles and other consumables in 0.5% Replaceable
Sodium Hypochlorite. Let the items remain submerged in the solution for 30 minutes and then
dispose as per the medical waste guidelines in your region.
8.3.2 Cleaning
The surface of the device should be cleaned using freshly prepared 0.5% Sodium Hypochlorite
solution and a clean cloth or tissue. This should be done once everyday and/or when the device is
moved to a different work space.
8.3.3 Spills
If you notice a spill in the tray placed in the cartridge holder, dispose the tray. Clean Replaceable
the insides of the cartridge holder with clean cloth or tissue or swab dipped in 70% Isopropyl
Alcohol (IPA). Wait for 5 minutes before inserting a new tray into the holder.Replaceable
8.3.4 Disposal of Instrumentation
Do not Dispose off Instrument as unsorted municipal waste. Contact Molbio for collection of
instrument.