Trueprep 603042001 Universal Cartridge Based Sample Prep Device
Product Specifications
- Product Name: Universal Cartridge Based Sample Prep Device
- Model Number: REF 603042001
- UDI: 8908007989972
Product Information
The Universal Cartridge Based Sample Prep Device is designed to streamline sample preparation processes in various laboratory settings. It comes with a user-friendly interface and a range of features to ensure efficient and accurate sample processing.
Product Installation
Installation Precautions:
Follow the installation instructions carefully to ensure proper setup of the device.
Environmental Requirements:
Place the device in a suitable environment as per the specified requirements to maintain optimal performance.
Precautions:
Adhere to all safety precautions mentioned in the user manual to prevent any accidents or damage to the device.
Materials Required
Contents:
Check that all the necessary materials are included with the device for proper operation.
Materials Required but not provided with device:
List of additional materials needed for certain operations that are not included with the device.
Usage Instructions
Top Panel View:
Refer to the top panel view section to familiarize yourself with the different components on the device.
Back Panel View:
Understand the back panel view for a comprehensive understanding of the device’s layout.
The Cartridge:
Learn about the cartridge and its role in the sample preparation process.
Plugging in the reagent bottle pack of 25T or reagent pack of 50T:
Follow the instructions to properly plug in the reagent bottle pack for efficient sample processing.
Placing the Cartridge in the device and starting the run:
Step-by-step guide on how to place the cartridge in the device and initiate the sample preparation process.
Errors, Alerts and Maintenance:
Be aware of common errors, alerts, and maintenance procedures to keep the device functioning optimally.
Product Safety
Prioritize safety measures while operating the device to ensure a secure working environment.
Product References
Refer to additional resources for further information on the product and its usage.
FAQ
How often should maintenance be performed on the device?
Maintenance should be performed as per the guidelines provided in the user manual, typically at regular intervals to ensure smooth operation of the device.
Preface
Contact Addresses
- Molbio Diagnostics Private Limited
- Registered Office: Plot No. L-46, Phase II D, Verna Industrial Estate, Verna, Goa – 403 722, INDIA.
Warranty
Warranty Information would be specified in the warranty certificate. Contact your Molbio representative for further information. Normally the instrument would be under warranty for a period of 12 Months from the date of Installation or 14 Months from the date of Invoice whichever is earlier. Post warranty services are also available from Molbio.
Trademarks
Trueprep® / Truelab® / Truenat® / Truepet® are trademarks of Molbio Diagnostics Private Limited
Intended Use
The Trueprep® AUTO v2 Universal Cartridge Based Sample Prep Kit works with Trueprep® AUTO v2 Universal Cartridge Based Sample Prep Device and is used for extraction and purification of nucleic acids from a wide range of biological specimens. It is an in vitro Diagnostics (IVD) device meant for professional use in near-patient, laboratory or any healthcare settings, by healthcare professionals or any user appropriately trained by a representative of Molbio Diagnostics.
Preamble
Before starting the nucleic acid extraction on the Trueprep® AUTO v2 Universal Cartridge Based Sample Prep Device it is important to read this USER MANUAL thoroughly and completely. All instructions contained in this manual need to be adhered to and non-adherence may lead to serious damage to the equipment.
Usage of the Trueprep® AUTO v2 User Manual
This user manual is intended to guide the USER through the installation, operation, and maintenance of the Trueprep® AUTO v2 Universal Cartridge Based Sample Prep Device, ensuring optimal performance and reliable results. It also provides the specifications of the device utilized in nucleic acid extraction, followed by a description of any encountered errors.
Conventions used in this Manual
This manual uses certain conventions that make it easier for you to differentiate types of instructions.
Note for customers: Any serious incident that has occurred in relation to the device shall be reported to the Molbio Diagnostics Private Limited and the competent authority of the Member State in which the user and/or the patient is established.
Text Conventions:
Note Conventions:
You will see three types of notes in this manual. Each has a symbol and a particular type of textual formatting to indicate what type of note it is.
The table below details their use, along with the associated symbol.
Introduction
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/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.
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.
Installation
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.
Environmental Requirement
The Trueprep® AUTO v2 has been designed to operate safely within the following environment Specifications:
- Estimated operating temperature (between 15°C to 45°C) at Relative Humidity (RH) between 10% to 90% (non-condensing)
- Estimated storage temperature (between 5°C to 45°C) at Relative Humidity (RH) between 10% to 90% (non-condensing)
- The unit should be stored on a flat, dry surface.
Specifications
Trueprep® AUTO v2 Universal Cartridge Based Sample Prep Device
| Principle | Proprietary matrix-based extraction |
| Operation | Fully automatic |
| Display screen | 2 line alphanumeric LCD |
| Power | Rechargeable Lithium Ion Battery Pack 7.4 V, 9600 mAh External AC/DC adaptor: Input 1.5A, 100/240V, 50/60 Hz;
Output 10V, 4.5A |
| Weight | 2.75 kgs |
| Size | 215 x 235 x 115 mm |
| Software | Proprietary firmware |
| Operating environment | Temperature 15 – 45°C, RH: 10 -90% |
“Trueprep® AUTO v2 complies with the emission and immunity requirements described in IEC 61326 series”.
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.
Materials Required
Contents
- Trueprep® AUTO v2 Universal Cartridge Based Sample Prep Device (REF603042001)
- AC Adapter (SMPS) with power cord to power (REF 603060001) – 1 No.
- Trueprep® replaceable tray for cartridge holder (REF603090001) – 25 Nos.
- Trueprep® cartridge stand (REF603100001) – 1 No.
- Trueprep® reagent pack holder (REF603160001) – 1 No.
- Trueprep® AUTO v2 plug-in connector for 25T reagent bottle (REF604090001) – 1 No.
- Trueprep® AUTO v2 Universal Cartridge Based Sample Prep Device User manual – 1 No.
Materials required but not provided with Device
Trueprep® AUTO v2 Universal Cartridge Based Sample Prep Device compatible with :
Trueprep® AUTO Universal Cartridge Based Sample Prep Kit (REF 60203AR05 / 60203AR25 / 60207AR50 / 60203AR100 / 60203AR200) / Trueprep® AUTO v2 Universal Cartridge Based Sample Prep Kit (REF 60207AR05 / 60207AR25 / 60207AR50 / 60207AR100 / 60207AR200) consisting of:
- Universal Reagent Pack (5/25/50/100/200 tests)
- Universal Cartridge Pack (5/25/50/100/200 Nos.)
- Disposable transfer pipette graduated (5×3 ml/25×3 ml/50×3 ml/100×3 ml/200×3 ml)
- Package insert (1 No.)
The Trueprep® AUTO v2 Universal Cartridge Based Sample Prep Device
Top Panel View
- 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
- The Power/In Use LED Indicator will glow when theTrueprep® AUTO v2 is switched on and when it is in use.
- It will glow red and blink continuously when the Trueprep® AUTO v2 is switched on and waiting for user input
- 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.
- It will glow red when the battery is low and needs to be charged
- It will glow blue when the Trueprep® AUTO v2 is being charged
Back Panel View
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 device.
Using the Trueprep® AUTO v2 Universal Cartridge Based Sample Prep Device
Charging/Using the Trueprep® AUTO v2 with the AC Adapter
- Press the Power button to switch on the Trueprep® AUTO v2
- 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.
- 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.
- Connect the other end of the AC Adapter to a mains socket.
- Switch on the mains power.
- 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.
Plugging in the reagent bottle pack of 25T or reagent pack of 50T
Plugging in the Reagent Bottle Pack of 25 T packsize:
- 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.
- Ensure that the tubing is fully immersed in the liquid upto the bottom of the reagent bottle.
- A set of bottles is sufficient for 25 tests.
- 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.
Plugging in the reagent pack of 50T pack size:
- 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.
- 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.
Buffer Resetting Procedure
When buffer count is completed (buffer count=25/50), the device will prompt for changing Reagent pack and resetting buffer count.
- 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.
- Following will be displayed on screen alternatively, once buffer count reaches 25/50.
- 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.
- Following will be displayed on screen alternatively, once buffer count reaches 50.
Switching ON/OFF the Trueprep® AUTO v2
- Press the Power button to switch on the Trueprep® AUTO v2. You will be prompted with the message ‘Buffer Count’.
- Later you will be prompted with the message for
- Press the Power button, when following screen will be displayed, release the power button.
The device will turn off automatically within 30 seconds.
Placing the Cartridge in the device and starting the run
Important: Only use the cartridge provided in the corresponding sample prep kits.
- Press the Eject button to open the cartridge holder. You will be prompted with the message
- Take a cartridge out of the cartridge pouch from the Trueprep® AUTO/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
- Push the cartridge holder gently inwards to close it shut. Press the Start Button to proceed. 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.
- Once the process is completed the device will give a beep sound with display message as below
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.
Remove the cartridge soon after the completion of Extraction, else there is a chance of Elute getting evaporated and the Final volume becoming Lesser. - Discard the cartridge as per the instructions in Section 8.3.
- Tray replacement
Cartridge holder contains one middle Replaceable tray as shown in Figure 13. Steps for replacement of Replaceable tray are as follows:- Step 1: Removal of the tray:
Remove the Replaceable tray from cartridge holder as shown in the Figure 14. - Step 2: Placement of the tray:
2a. Place the Replaceable tray in cartridge holder as shown in Figure 15.- Inspect the Replaceable tray in the cartridge holder.
- If there are liquids spilled in the tray, take out the tray and discard as per the instructions in Section 8.3.
- Clean the cartridge holder with 70% Isopropyl Alcohol (IPA) as described in Section 8.3.
- Replace the removed tray with a new tray and close the cartridge holder. (25 Replaceable trays are provided with the Trueprep® AUTO v2 device. More trays, if required, can be ordered from Molbio).
- Step 1: Removal of the tray:
Errors, Alerts and Maintenance
Error Messages
Accessing Menu
- Press 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.
- Release both the buttons, when following is displayed.
- In 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.
Exiting User Menu
Navigate to and select following item to exit from the menu.
Note: Shutdown is disabled in menu; in order to shutdown the device, user must exit from menu and press Power Button.
Flushing Procedure
- Replace Reagent Pack for 25T or SOT with Distilled water, using provided Plug-in connector.
- Select “Flush” menu and once it is selected tray will be ejected. Following screens will toggle with 2 seconds interval.
- Insert cartridge and press start, the flushing process will begin.
- The cartridge will be ejected once flushing is completed, following will be displayed on screen and device will go back to menu.
- Press Power button to exit without flushing.
Maintenance
Disposal of consumables
Discard the used cartridges, Replaceable trays, reagent bottles and other consumables in 0.5% 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.
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.
Spills
If you notice a spill in the Replaceable tray placed in the cartridge holder, dispose the tray. Clean the insides of the cartridge holder with clean cloth or tissue or swab dipped in 70% isopropyl Alcohol (IPA). Waitfor 5 minutes before inserting a new Replaceable tray into the holder.
Disposal of Instrumentation
Do not Dispose off Instrument as unsorted municipal waste. Contact Molbio for collection of instrument.
Safety
General Biohazard
Biological samples such as tissues, blood fluids, and blood of humans have the potential to transmit infectious diseases. Wear appropriate protective clothing, and gloves.
Protection from hazards related to device battery
- For the battery cell, chemical materials are stored in a hermetically sealed metal or metal laminated plastic case, designed to withstand temperatures and pressures encountered during normal use. As a result, during normal use, there is no physical danger of ignition or explosion and chemical danger of hazardous materials’ leakage.
- However, if exposed to a fire, added mechanical shocks, decomposed, added electric stress by miss-use, the gas release vent will be operated. The battery cell case will be breached at the extreme, hazardous materials may be released. Moreover, if heated strongly by the surrounding fire, acid gas may be emitted.
References
- Nasir A., Rita C.P.R., Alexandre D.T.C., et al. (2017) Current Nucleic Acid Extraction Methods and Their Implications to Point-of-Care Diagnostics. BioMed Research International. 1-13.
- Ruihua T., Min L., Xueyan Y., et al. (2022) Comparison of paper-based nucleic acid extraction materials for point-of-care testing applications. Cellulose. 29: 2479–2495.
- Xing S., Anne M.C. (1999) Cellulose as a Matrix for Nucleic Acid Purification. Analytical Biochemistry 267: 415–418.
- Vijayalakshmi J., Surekha A., Renuka D.A., et al. (2019) Truenat – A Novel Diagnostic Tool for Rapid Detection of Mycobacterium Tuberculosis and Rifampicin Resistance in Pulmonary Samples. Int.J.Curr.Microbiol.App.Sci 8(10): 1-9.
- Gomathi N.S., Manjula S., Urvashi B.S., et al. (2020) Multicentric validation of indigenous molecular test Truenat™ MTB for detection of Mycobacterium tuberculosis in sputum samples from presumptive pulmonary tuberculosis patients in comparison with reference standards. Indian J Med Res. 152: 378-385.
Symbols Keys
ABOUT COMPANY
- Molbio Diagnostics Private Limited
- Registered Office & Manufacturing Unit:
- Plot No. L-46, Phase II D,
- Verna Industrial Estate, Verna,
- Goa – 403 722, INDIA
- www.molbiodiagnostics.com
- Email: sales@molbiodiagnostics.com (Sales Enquiries)
- customersupport@molbiodiagnostics.com (Feedback and Customer Support)
- Qarad EC-REP BV, Pas 257, 2440 Geel, Belgium
Documents / Resources
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Trueprep 603042001 Universal Cartridge Based Sample Prep Device [pdf] User Manual 603042001 Universal Cartridge Based Sample Prep Device, 603042001, Universal Cartridge Based Sample Prep Device, Cartridge Based Sample Prep Device, Based Sample Prep Device, Sample Prep Device, Prep Device, Device |
