MBS NextGenPCR User manual

NextGenPCR™
THERMAL CYCLER | INSTRUCTIONS FOR USE
REVISION 2.0
1
3
4
8
5
C
E
R
T
I
F
I
E
D
ISO

Important: Read these instructions for use. Failure to read, understand and follow the instructions in this document may result in damage to the
unit, injury to operating personnel, or poor device performance. Contact your local distributor or a Molecular Biology Systems technical specialist
if there are any doubts regarding the proper use of your system.
CAUTION! 
Revision History
Version Date Description
1.0 08/02/2020 Development of the IFU – intial version
2.0 09/28/2023 Following parts of the document were updated: Safety symbols,
Contact information, Product information, Safety, Footer/Header;
Manufacturer registered place of business:
Molecular Biology Systems, B.V
Diazweg 7, 4462 HG Goes, The Netherlands
T: [phone]
For Research Use Only. Not for use in diagnostic procedures.
For Professional Use Only.
is a registered trademark of Molecular Biology Systems, B.V.
All other trademarks are the sole property of their respective owners.

3
NextGenPCR™ Thermal Cycler - Instructions for use, v2.0, October 2023
INSTRUCTIONS FOR USE
NextGenPCR™
THERMAL CYCLER
PREFACE 4
1. WARRANTY 7
2. PRODUCT INFORMATION 10
3. OPERATION SAFETY 16
4. ELECTRICAL SAFETY 19
5. GETTING STARTED 20
6. OPERATING THE INSTRUMENT’S FIRMWARE 22
7. MICROPLATE PREPARATION 28
8. DEVICE COMPATIBILITY 30
9. TROUBLESHOOTING 31
10. MAINTENANCE AND SERVICING 33

PREFACE
Introduction
Welcome to the user manual for the NextGenPCR™ Thermal Cycler! We are thrilled to introduce you to our

technology, intuitive controls, and unparalleled performance, the NextGenPCR™ Thermal Cycler is engineered to
meet the demands of both novice researchers and seasoned professionals alike.


genetic analyses, the NextGenPCR™ Thermal Cycler is your ideal companion for achieving reliable and reproducible
results. Let’s embark on this exciting journey to unlock the potential of your research together!
How to use this manual

the NextGenPCR™ Thermal cycler in molecular biology applications. The manual provides information on the machine’s

machine, including power requirements and environmental conditions. Step-by-step procedures are outlined for
operating the machine, such as programming PCR protocols and adjusting temperature and time parameters.
The manual includes guidelines for initial device setup, creating and optimizing PCR programs, covering

Maintenance guidelines address routine cleaning, calibration, and the replacement of consumables.

assistance is provided. Safety considerations are emphasized.
IMPORTANT! Before operating the NextGenPCR™ Thermal Cycler, carefully read and familiarize yourself with
the user manual provided by the manufacturer. Understand the device’s capabilities, limitations, and safety
precautions. Ensure that anyone using this product has received instructions in general safety practices for
laboratories and the safety information provided in this document.
4
NextGenPCR™ Thermal Cycler - Instructions for use, v2.0, October 2023

5
NextGenPCR™ Thermal Cycler - Instructions for use, v2.0, October 2023
Safety alert words
There are four safety symbols used in this document at points where the user shall be aware of relevant hazards.
Each safety word implies a particular level of observation or action.
IMPORTANT! Relates to important information or instructions that are not directly related to safety hazards but

schedules, special considerations.
CAUTION! Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor to

carefully to prevent accidents.
WARNING! Indicates a potential hazard or unsafe practice that, if not avoided, could cause serious injury,

guidelines and precautions.
DANGER! Is a strong and urgent safety word used to indicate an immediate and severe risk that, if not

immediate attention and adherence to safety procedures.
Reporting
IMPORTANT! Any serious incident that occurs in relation to the device shall be reported to the manufacturer
and the Member State in which the user is established.
How to obtain support and more information
Resource How to contact
Local NextGenPCR™ Find our representative in your country on our nextgenpcr.com website.
representatives If no local representative is present in your country, you can contact us
directly by emailing us at [e-mail]
Technical notes and literature Technical notes and literature can be found on www.nextgenpcr.com
Technical Specialist Contacting our technical specialist is possible by emailing [e-mail]
Customer support E: [e-mail] | T: [phone]

6
NextGenPCR™ Thermal Cycler - Instructions for use, v2.0, October 2023
1. WARRANTY
1.1 Warranty Information
The system’s warranty is included in the purchase price. Molecular Biology Systems B.V. warrants this machine to
be free from defects in material and workmanship when used under normal laboratory conditions for one (1) year.




1.2 Warranty Coverage
The NextGenPCR™ Thermal Cycler, including the main unit, accessories, and software provided with the system, is
covered under this warranty.
1.3 Warranty Duration
Molecular Biology Systems, B.V. warrants this PCR Thermal Cycler against defects in materials and workmanship
for a period of 1 year from the date of purchase.
1.4 Warranty Conditions
To ensure that your warranty remains valid, please adhere to the following conditions:
PROPER USE
This warranty is valid only if the NextGenPCR™ Thermal Cycler is used in accordance with the instructions provided
in the manual and for its intended purpose of performing polymerase chain reactions (PCR) and related molecular
biology applications.
UNAUTHORIZED MODIFICATIONS

NextGenPCR™ Thermal Cycler.
EXTERNAL FACTORS
Damages resulting from accidents, misuse, negligence, natural disasters, or other external factors beyond the
control of Molecular Biology Systems, B.V. are not covered under this warranty.

7
NextGenPCR™ Thermal Cycler - Instructions for use, v2.0, October 2023
ROUTINE MAINTENANCE
Please note that routine maintenance and consumable parts, such as fans, belts (stopper motor), fuses, or other
parts subject to normal wear and tear, may have separate warranty terms or may not be covered under the main

FORCE MAJEURE
In the event of unforeseeable circumstances beyond the control of either party, including natural disasters,


terminated without penalty.
1.5 Warranty Claim Process
In the event that you need to make a warranty claim, please follow these steps:
Contact Molecular Biology Systems, B.V. customer support by phone or email, using the contact details provided in
the manual. Provide proof of purchase, such as the original sales receipt or invoice, indicating the date of purchase.
Molecular Biology Systems, B.V.’s customer support team will guide you through the necessary steps to assess
the issue and initiate the warranty claim process.
1.6 Return of the instrument
If there is a need to return the instrument either for servicing or replacement, please use the original packaging
materials, if available. The manufacturer’s packaging is designed to provide the best protection during shipping.
If the original packaging is unavailable, use sturdy, cushioned packaging materials to keep the instrument stable
and secure during transit.
The user is responsible for properly decontaminating the thermal cycler to eliminate any residual DNA molecules
or other biological contaminants before returning the instrument. For decontamination and cleaning instructions
refer to section 10.3 Maintenance.
After cleaning, allow the thermal cycler to dry completely to avoid any moisture-related damage during transpor-
tation. Include all relevant documentation, such as the original purchase receipt, warranty information, and any
notes about the instrument’s condition or issues you encountered.
Mark the package correctly. Before shipping, communicate with the manufacturer or distributor and let them


8
NextGenPCR™ Thermal Cycler - Instructions for use, v2.0, October 2023
1.7 Limitations of Liability
Molecular Biology Systems, B.V. shall not be held liable for any consequential damages, or data loss resulting

that can be claimed under this warranty is limited to the original purchase price of the PCR Thermal Cycler.
1.8 Jurisdiction
This warranty is governed by the laws of the Netherlands. Any disputes arising from this warranty shall be subject

subject to change. For the most up-to-date and accurate information, please consult the warranty documentation
provided by Molecular Biology Systems, B.V. at the time of your purchase.
If you have any further questions or concerns regarding the warranty, please do not hesitate to contact our
customer support team.

9
NextGenPCR™ Thermal Cycler - Instructions for use, v2.0, October 2023
2. PRODUCT INFORMATION

The NextGenPCR™ Thermal Cycler is a stand-alone, electrically powered, automated, non-sterile laboratory instrument
intended to amplify target deoxyribonucleic acid (DNA) in a clinical specimen using heat-stable polymerase enzymes
and cycles of repeated heating and cooling (i.e., thermal cycling) to replicate a product [i.e., a polymerase chain
reaction (PCR)]. (GMDN 48031). The instrument is not intended for self-testing procedures, nor is it intended for
use to directly diagnose or detect the presence of a pathogenic molecule or infectious agent.
For research use only. Not for use in diagnostic procedures. For professional use only.
 ListofDeviceIdentiers
MBS Product Catalog Code #10001
GMDN 48031 (July 5/2023)
2.2 Intended purpose and intended users
The NextGenPCR™ Thermal Cycler is a laboratory instrument intended to cycle the temperature of samples in a
microtiter plate between two or more temperatures in an ultrafast way in order to perform a polymerase chain

2.3 What is included?
The NextGenPCR™ Thermal Cycler system includes the following components: NextGenPCR™ Thermal Cycler,
power cable (EU 220V or USA 110V) and the Instructions for Use.
2.4 About
Since the inception of the polymerase chain reaction (PCR) technique in 1983, laboratory PCR instruments have
been reliant on slow Peltier technology to transfer heat from an active thermal element to a sample container.
The fastest Peltier element-based thermal cycling instruments available on the market can ramp temperatures by



10
NextGenPCR™ Thermal Cycler - Instructions for use, v2.0, October 2023
NextGenPCR™ thermal cycling technology radically improves PCR cycling times by eliminating temperature ramping
times from any cycling program, owing to its innovative sample heating technology. In a NextGenPCR™ reaction, an
ultrathin plastic microplate sample container is swiftly moved between three distinct heating zones, each set to a
constant temperature. Via compression of two heating blocks per heating zone when the microplate container is
in place, samples are heated or cooled nearly instantaneously resulting in much shorter cycling times as compared
to regular PCR reactions and instruments.
Denat.
3s
at 98°C Denat.
3s
at 98°C
Annealing
9s
at 60°C
Time (s)
Conventional heat block heating/cooling:
-40% of total cycling time @ 6°C/s
-70% of total cycling time @ 1°C/s
NextGenPCR near instant heat transfer:

  Time (s)
Temperature (°C) Temperature (°C)
Annealing
9s
at 60°C
Extension
6s
at 72°C Extension
6s
at 72°C

Conventional PCR
(variable temp.)
NextGenPCR™
constant temp. 1 constant temp. 2 constant temp. 3
constant temp. 1 constant temp. 2 constant temp. 3
Heat blocks close for optimal heat transfer and mixing
Microplates move to the thermal zone
Microplates move to the next thermal zone
NextgenPCR
™
Ultra thin reaction well
Upper heat block compression force
Lower heat block compression force
Denaturation
Denaturation
Annealing
Annealing
Extension
Extension
Thermal + Chemical


11
NextGenPCR™ Thermal Cycler - Instructions for use, v2.0, October 2023
The NextGenPCR™ Thermal Cycler has universal heating zones that accept multiple sizes of microplate container

interior of the instrument.
Note: For compatibility information please refer to Chapter 8 Device Compatibility
2.5 Instrument Features
Features
Interface 5” HD Touch Screen
Lid* Manual operation
Connectivity 1× USB-A port (used for service and calibration only)
1× USB-B port (used for service and calibration only)
1× ethernet port
1× C14 power inlet (110V/220V)
1× Power switch
Serial number See the ID plate on the bottom of the machine
MAC address See the ID plate on the bottom of the machine
Operating system Linux
Internal data storage SD card 64GB
Storage capacity 106 entries for users or protocols
*Note: For use with a robotic system the cycler can be operated without a lid.

1
2
5
4
1
2
3
Front view: (1) Touch screen interface
(2) Microplate loading station/lid
Rear view: 
(3) USB type A, USB type B (for servicing and calibration only)
(4) Ethernet port (5) Fans

12
NextGenPCR™ Thermal Cycler - Instructions for use, v2.0, October 2023

DIMENSIONS
Height 240 mm / 9.5”
Width 196 mm / 7.7”
Depth 445 mm / 17.5”
Weight 18 kg / 39.7 lb
TEMPERATURE PROFILE
Position* Calibrated range** (min-max)
Heat Block #1 (annealing zone) 48°C – 74°C
Heat Block #2 (extension zone) 68°C – 74°C
Heat Block #3 (denaturation zone) 94°C – 100°C
* Orientation from the front side to the back side of the machine.
IMPORTANT! 
at an ambient temperature of 20°C ± 5°C.
TEMPERATURE CONTROL
Calibrator PT-100
Accuracy ± 0.2°C of displayed temperature
  
Heat Block positions 3
Heat Block dwell time (min/max) 0.5 – 999 sec
POWER
Voltage 90-260V, 50/60Hz
Power (max/avg) 680W/150W
Fuse ratings T 6.3A

13
NextGenPCR™ Thermal Cycler - Instructions for use, v2.0, October 2023
3. OPERATIONAL SAFETY
WARNING! 
result in personal injury or damage to the instrument.
3.1 General safety
Before operating the NextGenPCR™ Thermal Cycler, carefully read and familiarize yourself with the user
manual provided by the manufacturer. Understand the device’s capabilities, limitations, and safety precautions.
Ensure that anyone using this product has received instructions in general safety practices for laboratories
and the safety information provided in this document.
IMPORTANT! It is essential to make certain that individuals operating the instrument have received comprehensive

WARNING! The device’s surface must never become hot during operation. If this does happen, disconnect
the device immediately and notify the manufacturer of the issue.
3.2 Use of Personal Protective Equipment (PPE)
Always remember to wear the appropriate Personal Protective Equipment (PPE) while using the thermal cycler.
This includes, but is not limited to, lab coats, safety goggles, and disposable gloves. PPE serves as a barrier to
protect you from potential chemical splashes, biohazards, or any accidental spills that may occur during operation.
By wearing the recommended PPE, you not only safeguard yourself but also maintain the integrity of your experiments.
3.3 Visual inspection
Visually inspect the thermal cycler before each use. This includes checking for any visible damage, loose cables,
or irregularities.
WARNING! If any issues are found, refrain from using the equipment and contact the manufacturer or
authorized service personnel.

14
NextGenPCR™ Thermal Cycler - Instructions for use, v2.0, October 2023
3.4 Moving and lifting the device
CAUTION! The NextGenPCR™ instrument weighs approximately 18kg. The movement and positioning of the
instrument should only be carried out by authorized personnel or the designated vendor. If you need to relocate
or lift the instrument after installation, it is essential to refrain from doing so without assistance from others,
utilization of suitable moving equipment, and the application of proper lifting techniques. It is crucial to note that
improper lifting can result in severe and lasting back injuries. Depending on the weight involved, the relocation
or lifting of an instrument may necessitate the involvement of two or more individuals. Never move or carry the
instrument when used or connected to the power/machine electricity supply.
3.5 Cleaning or decontaminating the device
CAUTION! Prior to utilizing a cleaning or decontamination method that deviates from the manufacturer’s recom-
mended procedures, verify with the manufacturer whether the proposed method will cause any damage to the equipment.
3.6 Symbols on the device
3.6.1 ENVIRONMENTAL SYMBOLS ON THE DEVICE
Symbol Description
Do not dispose of this product as unsorted municipal waste. Follow local
municipal waste ordinances for proper disposal provisions to reduce the
environmental impact of waste electrical and electronic equipment (WEEE).
3.6.2 INFORMATION SYMBOL ON THE DEVICE
Symbol Description
A QR code readable by a digital device leads the customer to the
Instructions for Use (TBD)

Symbol Description
European safety and EMC standards.
Safety
The protection provided by the instrument may be impaired if the instrument
  
This device meets European requirements for safety (Low Voltage Directive 2006/95/EC).
Directive 2014/30/EU – Electromagnetic Compatibility (EMC) Directive
Directive 2014/35/EU – Low Voltage Directive (LVD)
Overvoltage category II (IEC 60664-1)

15
NextGenPCR™ Thermal Cycler - Instructions for use, v2.0, October 2023
4. ELECTRICAL SAFETY
4.1 Electric shock hazard
DANGER! Severe electrical shock can result from operating the NextGenPCR™ Thermal Cycler without its side
panels in place. Do not remove the side panels. High-voltage contacts are exposed when instrument panels are
removed from the instrument.
4.2 Fire hazard – fuses
CAUTION! Improper fuses or high-voltage supply can damage the instrument wiring system and cause a

matches the power supply in your laboratory.
CAUTION! 

4.3 Electrical hazard – power
DANGER! Grounding circuit continuity is vital for the safe operation of equipment. Never operate equipment

supply in your facility. Plug the system into a properly grounded receptacle with adequate current capacity.

16
NextGenPCR™ Thermal Cycler - Instructions for use, v2.0, October 2023
5. GETTING STARTED
5.1 System placement requirements
IMPORTANT! The NextGenPCR™ Thermal Cycler shall be placed in the control laboratory environment.
Place the NextGenPCR™ Thermal Cycler on a smooth level surface before use. Ensure that the surface can support
the weight of the instrument without wobbling or tipping over. Avoid placing the instrument adjacent to heaters,
cooling ducts, or in direct sunlight. Fluctuations between day and night temperatures can cause system instability.
Place the device away from any equipment that vibrates, such as a refrigerator or centrifuge.
5.2 Environmental requirements
The NextGenPCR™ Thermal Cycler is designed to operate optimally under the following environmental conditions:
Room temperature 20°C ± 5°C
Relative humidity, non-condensing 60% - 80%
IMPORTANT! Make sure the NextGenPCR™ Thermal Cycler is at ambient temperature for at least 30 minutes

5.3 Unpacking and Installation
For the proper installation of the device, the following steps are necessary:
Verify if the package contains all the necessary content to set up the system:
• NextGenPCR™ Thermal Cycler
• Power cable (EU 220V or USA 110V)
Remove all contents from the packaging.
IMPORTANT! Ensure that the air inlet and outlet vents on the bottom and rear of the system are free from
obstruction.
IMPORTANT! Avoid overhanging any part of the system over the bench edge. Make sure there is some space
between the NextGenPCR™ Thermal Cycler and any objects placed in proximity (at least 5 centimeters / 2 inches).
IMPORTANT! Store the original packaging in a safe location. In the event of returning the machine for servicing or
repairs, the machine is required to be packed in the original casing (see Section 1.6 Return of instrument).

17
NextGenPCR™ Thermal Cycler - Instructions for use, v2.0, October 2023
DO NOT TURN ON THE INSTRUMENT IMMEDIATELY AFTER CONNECTING.
DIRECTLY PROCEED WITH THE NEXT STEPS IN ORDER.
Connect the supplied power cable to the NextGenPCR™ Thermal Cycler and then to the electrical supply.
It is advised to use a grounded electrical supply source to ensure the safety of the end user.
IMPORTANT! Remove the foam block inserted into the sample loading tray before switching it on for the rst time.
To access the sample loading tray, lift the lid at the front of the system. After removing all packaging materials, switch
on the machine using the power switch at the back of the machine. The display will light up, and the microplate holder
will initialize its position.
The NextGenPCR™ Thermal Cycler will start heating to a baseline state of 94°C for the denaturation zone, 50°C for the
annealing zone, and 72°C for the extension zone and is ready for use.
Note: The baseline temperature settings will be automatically adapted to the temperature settings of the last run.



it is recommended to perform an annual calibration as part of routine maintenance. See Section 10 Maintenance
and Servicing.

18
NextGenPCR™ Thermal Cycler - Instructions for use, v2.0, October 2023
6. OPERATING THE INSTRUMENT’S FIRMWARE
6.1 Connecting the instrument for remote monitoring

via Windows on a desktop or laptop. This feature allows users to, for example, check the status of the cycler from

Note: To use the remote function, both the cycler and the laptop must share the same network.
The following components are needed:
• PC (desktop, laptop) with preinstalled software.
• OS Windows 7 or later
• Advanced IP Scanner v2.5.1 or later
• Firefox v114.0 or later, or an equivalent internet browser
• RJ45 ethernet cable.
To access your NextGenPCR™ Thermal Cycler using your PC follow these steps:
• Connect the NextGenPCR™ Thermal Cycler to the network access point such as a router or WiFi hub
(avoid direct connections to a PC or laptop) with an ethernet cable.
The socket is located at the back of the NextGenPCR™ Thermal Cycler, near the power inlet.
• Turn on the NextGenPCR™ Thermal Cycler using the power switch.
• Start the Advanced IP Scanner software.
• Click the Scan button at the top left of the screen.
• Inthelistofidentieddevices,therewillbeanaccesspointmanufacturedby‘CameronetGmbH&Co.KG’:
• Copy the IP address associated with the ‘Cameronet GmbH & Co. KG’ device (right click, then ‘Copy’ – ‘IP’) to the address
bar of your internet browser and press enter. You will now log in to the NextGenPCR™ Thermal Cycler software.
• The NextGenPCR™ Thermal Cycler software currently running on your instrument will be displayed in the
browser window.
• The instrument can now be controlled using keyboard and mouse inputs.
• 
Note: Recommended IP range should be as large as possible

19
NextGenPCR™ Thermal Cycler - Instructions for use, v2.0, October 2023
6.2 Home screen
This screen serves as a login point where users can log into their existing account or add a new user if needed.

By tapping the username of choice, a keyboard will pop up, and you will be prompted to input your password:
CREATE A USER PROFILE
To add a new user, press “Add User” and the following screen will appear:

IMPORTANT! 
The new User can now be accessed from the home screen.

20
NextGenPCR™ Thermal Cycler - Instructions for use, v2.0, October 2023
WARNING! To prevent unauthorized access to the information portfolio, ensure that the users’ information
is stored securely.
DELETE A USER PROFILE
To remove a user from the user list, click the red cross icon next to the user:
Note: As this feature is not typically required by end users (the NextGenPCR™ Thermal Cycler can store up to 106


6.3 Protocol menu
LOGIN TO THE DESIRED USER PROFILE.


As an example, a PCR program with 10 minutes of initial denaturation at 98°C, followed by 35 cycles of 30
seconds of denaturation at 98°C, 30 seconds of annealing at 60°C and 30 seconds of extension at 72°C,
followedby10minutesofnalextensionat72°Ccanbeprogrammedasfollows: