Molbio Trueprep AUTO Bedienungsanleitung

True AUTO prep™
User Manual
603041001
REF
DIAGNOSTICS
IVD
Universal Cartridge Based
Sample Prep Device


DIAGNOSTICS
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 5
6.1 A Top Panel View 5
6.1B Back Panel View 6
6.2 The Cartridge 6
7 Using the Trueprep™ AUTO 7
7.1 Charging/Using the Trueprep™ AUTO with the AC Adapter 7
7.2 Plugging in the reagent bottles 8
7.3 Switching ON the Trueprep™ AUTO 9
7.4 Placing the Cartridge in the device and starting the run 9
8 Errors, Alerts and Maintenance 12
8.1 Error Messages 12
8.2 Alert Messages 13
8.3 Maintenance 14

DIAGNOSTICS
2
TABLE OF FIGURES
Figure 1: The Trueprep™ AUTO Top View, with cartridge holder 5
shown in the front panel
Figure 2: The Trueprep™ AUTO Back Panel, with tubing and caps for plugging 6
in reagent bottles from the Reagent Pack of the
Trueprep™ AUTO Universal Cartridge Based Sample Prep Kit
Figure 3: Disposable Trueprep™ AUTO 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
Figure 6: The Blue Charging LED Indicator Glowing 8
Figure 7: Reagent bottles with tubing fully immersed in liquid 9
Figure 8: The cartridge holder opened after eject button is pressed 9
Figure 9: Cartridge being placed in cartridge holder 10
Figure 10: Cartridge placed in cartridge holder in correct orientation 10
Figure 11: Replaceable tray and Rail guards in cartridge holder 11
Figure 12: Removal of Replaceable Tray and Rail guards from cartridge holder 11
Figure 13: Replacement of discarded Replaceable tray and Rail guards with new 12

DIAGNOSTICS
3
1. Introduction
1.1 The Trueprep™ AUTO 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 microPCR 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 Universal Cartridge
Based Sample Prep Device together with Trueprep™ AUTO Universal Cartridge Based
Sample Prep Kit provides an easy method of nucleic acid extraction and purification.
Trueprep™ AUTO 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 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, plural fluid, lymph node aspirate, pus,
peritoneal fluid, saliva, swab specimens and culture specimen.
1.2 Principle
The Trueprep™ AUTO 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.

DIAGNOSTICS
4
2 Installation
2.1 Installation Precautions
Do not install the Trueprep™AUTO next to instruments that may cause
vibrations or electromagnetic interference.
Do not store the Trueprep™ AUTO 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 in an atmosphere of potentially explosive liquids,
vapors and gas.
Always place theTrueprep™ AUTO on a flat surface in an upright position.
2.2 Environmental Requirement
The Trueprep™ AUTO 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
4 Precautions
Check for Low Battery before using the Trueprep™ AUTO (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, 11.6 Ah
External AC/DC adaptor: Input 1.5A, 100/240V, 50/60 Hz;
Output 10V, 4.5A
2.9 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 Device

DIAGNOSTICS
5
5 Materials Required
5.1 Contents
Trueprep™ AUTO Universal Cartridge Based Sample Prep Device (REF603041001)
AC Adapter (SMPS) with power cord to power -1No.
(REF603090001)- 25 Nos.Trueprep™ Replaceable tray for cartridge holder
R for cartridge holder Trueprep™ ail guards (10 left hand side and 10 right hand side)
(REF603140001) -10 pairs.
(REF603100001) - 1No.Trueprep™ Cartridge Stand
Bottle holder tray (REF603110001) - 1No.Trueprep™
User Manual -1No.
5.2 Materials Required but not provided with Device
Trueprep™ AUTO Universal Cartridge Based Sample Prep Device compatible with :
Trueprep™ AUTO Universal Cartridge Based Sample Prep Kit (REF60203AR25)consisting of
Universal Reagent Pack (25 tests)
Universal Cartridge Pack (25 nos.)
Disposable transfer pipette graduated (25 x3ml)
Package insert (1 No.)
TM
6. The Trueprep AUTO
6.1A Top Panel View
Figure 1 : The Trueprep™AUTO Top View, with cartridge holder shown in the front panel.
The Power button switches on and switches off the Trueprep™ AUTO
The Eject button opens the cartridge holder
CHARGING /LOW
BATTERY LED
Indicator
POWER button
START button
POWER/IN USE
LED Indicator
EJECT button

The Start button is used to begin sample processing
The Power/In Use LED Indicator will glow when the Trueprep™ AUTO is switched on and
when it is in use.
i) It will glow red and blink continuously when the Trueprep™ AUTO 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 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 is being charged
6.1B Back Panel View
Figure 2: The Trueprep™ AUTO Back Panel, with tubing and caps for plugging in reagent bottles
from the Reagent Pack of the Trueprep™ AUTO 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.
Figure 3: Disposable Trueprep™ AUTO cartridge for sample processing
Elute
Chamber
Matrix Chamber
Sample
Chamber
Dump
Cap
DIAGNOSTICS
6

DIAGNOSTICS
7
7 Using the Trueprep™ AUTO
7.1 Charging/Using the Trueprep™ AUTO with the AC Adapter
7.1.1 Press the Power button to switch on the Trueprep™ AUTO
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 device will not let you begin a 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 on battery charge.
For charging or to use Trueprep™AUTO 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

DIAGNOSTICS
8
Figure 5: The Charging Port in right hand side of the Back Panel of the Trueprep™ AUTO
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 using the mains power.If the Trueprep™
AUTO is being charged, the charging LED Indicator will glow blue. Charging takes ~9-10 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 bottles
7.2.1 Before starting a run for the first time, plug in the colour coded reagent bottles from the
TM
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. Discard the
reagent bottle cap once the bottle is plugged in.
7.2.2 Ensure that the tubing is fully immersed in the liquid upto the bottom of the reagent bottle.
7.2.3 A set of bottles is sufficient for 25 tests.
7.2.4 The device will prompt when 25 tests have been completed and the bottles have to be replaced.
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