TAN Bead Maelstrom 9600 User manual

TANBead Nucleic Acid Extractor
(Non-Sterile)
039.M0601.X62 Rev V1.1_2022.06
Maelstrom 9600
User Manual

1. Introduction …………..……………………………………….……………. 4
2. Instrument overview …..……........………………….…….......…….11
3. Before usage …………..……………………………..…...….……...…... 15
4. Main page .............................…………………….……....................... 17
5. Tips …………..........................….……………………………................... 18
6. Run ...........................................………………………………................. 19
7. Edit .............................................…………………………...................... 26
8. Reports ............................…………………………............................... 30
9. UV Lamp and HPEA ...................…………………………................ 31
10. Setting ............................................................................................... 33
11. Cleaning and maintenance ...................................................... 35
12. Disposal ............................................................................................ 35
13. Patent ................................................................................................ 35
14. Appendix ......................................................................................... 36
Table of Contents
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About Manual
3
The label on the instrument, the User Manual, and other
packaging material may contain following symbols:
The CE mark
In Vitro Diagnostic Medical Device
Authorized European Representative
Caution, consult accompanying documents
Hot surface, risk of burns
Watch your fingers and your hands
The symbol indicates that the product should not be
discarded as unsorted waste but must sent to separate
collection facilities for recovery and recycling
Catalog number
Serial number
Manufacturer
The date of manufacture
Non-Sterile
Temp Limit
(Operating)
Biologic Risks
Keep Dry
Keep Away From Sunlight
Consult Instructions for Use
Humidity Limit
(Operating)
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Maelstrom 9600 is an automated nucleic acid platform designed for
high-throughput applications. Specialized spin tips enable super
mixing efficiency of magnetic beads and larger processing volume.
With intuitive interface and flexible program, Maelstrom 9600 can
boost molecular diagnostic laboratory productivity by transforming
routine operations into a walk-away solution.
Operation Principle
Maelstrom 9600 uses magnetic rods to collect and transfer magnetic
beads and spin tips to mix suspension. Rotating the spin tips will mix
suspension very well. Extended magnetic rods can collect magnetic
beads efficiently.
Purified nucleic acids can be obtained after cell lysis, nucleic acids
absorption, wash and elution.
Intended Use
⚫Maelstrom 9600 can be used in combination with TANBead
Nucleic Acid Extraction Kit to extract DNA/RNA from specimen.
⚫Maelstrom 9600 can handle magnetic beads for purification of
nucleic acid.
⚫This product should be operated by a physician, medical examiner
or related professionals.
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1. Introduction
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5
Intended Purpose
Sample Type
Sample Tissue Bacteria Stool
Kit
612
serie
s
6T2
series 6K2 series 61G series
6SC series
Sample Blood cfDNA
Kit 611 series
61E series
621 series
61C
series
Sample Virus
Kit 615
series 635 series 665 series 685 series 61H series
1. Introduction
Maelstrom 9600 automated nucleic acid extractor is an in vitro
diagnostic device, which is used to extract and purified nucleic acids
from human and biological samples. The purified nucleic acid can be
used with any downstream application employing PCR-based
qualitative, semi-quantitative and quantitative assays. This product
should be operated by technicians, physicians, and biologists with
well-trained in molecular biological techniques. It is suitable for all
population in human.
Maelstrom 9600 automated nucleic acid extractor is equipped with
different types of TANBead Nucleic Acid Extraction kits, which can
extract and purify nucleic acids from biological samples such as
blood, cfDNA, virus, tissues, Bacteria and stool. Please refer to the
following for types of specimens required.
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1. Introduction
Environmental Requirements
To avoid shortening of the lifespan of the instrument, use Maelstrom
9600 in a location that meets the following criteria:
⚫Choose a location that has good air circulation.
⚫Place Maelstrom 9600 on the table that can bear the weight of
Maelstrom 9600 (112 kg).
⚫Do not use Maelstrom 9600 in a location where there is large
temperature variability or high humidity.
⚫Operation condition:
Temperature: 4-40℃
Humidity: 40-80%
⚫Storage and transportation condition:
Temperature: 8-40℃
Humidity: 0-85%
⚫Maximum operating altitude: 2000 m
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Safety instructions and guidelines
⚫This device can be used with potentially biohazardous materials.
Use appropriate personal protective equipment (gloves, safety
goggles, lab coat, etc.) for handling and disposing of biohazardous
materials.
⚫Under normal condition, sound pressure level from Maelstrom
9600 does not exceed 80 dB and cause a hazard. Please contact
technical support in case of higher sound pressure level.
⚫This device can be hazardous due to the use of chemical and
biohazardous substances.
⚫Users should adhere to their institutional guidelines for the
handling and disposal of all infectious substances used with this
device.
⚫It is important to clean the device after every use. If samples or
reagents have been spilled, it is important to clean the instrument
immediately to avoid damage or contamination of samples.
⚫This device is to use with the compatible spin tips. Using
incompatible spin tips may cause poor extraction performance.
⚫Read this user manual in its entirety prior to operating the device.
Failure to read, understand, and follow the instructions in the
manual may result in damage to the device, injury to laboratory
and operating personnel or poor performance.
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1. Introduction
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Safety and EMC Information
Safety Requirements
⚫The medical device has passed the tests and conformed to the
standards of IEC 61010-1:2010 / AMD 1:2016 /COR 1:2019,
“Safety requirements for electrical equipment for measurement,
control, and laboratory use - Part 1: General requirements”.
⚫The medical device has passed the tests and conformed to the
standards of IEC 61010-2-101:2018, “Safety requirements for
electrical equipment for measurement, control and laboratory use
- Part 2-101: Particular requirements for in vitro diagnostic (IVD)
medical equipment”.
EMC Requirements
⚫The medical device has passed the tests and conformed to the
standards of IEC 61326-1:2012 & IEC 61326-2-6:2012,“Electrical
equipment for measurement, control and laboratory use - EMC
requirements - Part 2-6: Particular requirements - In vitro
diagnostic (IVD) medical equipment”.
⚫The medical device has passed the tests and conformed to
following standards:
EN 61326-1:2013
EN 61326-2-6:2013
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1. Introduction
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Please note that following accessories accompanying with instrument
may vary from region to region.
Equipment list
9
1. Introduction
Power cord x1
Remark : Power cord varies from region to region
A plate of spin tips x1
Magnetic separator x1 User manual x1
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2. Instrument overview
Maelstrom 9600
Front view
ITEM SPECIFICATION
Model Maelstrom 9600
Weight 112 kg (248 lbs.)
Dimensions 87 (W) x 57.5 (L) x 70 (H) cm
Power supply 220-240Vac
Capacity 96 samples per run
Process. volume 50 μl –1600 μl
Spin speed up to 3000 rpm
Heater 4 heating plates
Magnetic rod >3000 gauss
Display 7-inch touchscreen
Fuse 250 V, 5 A
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2. Instrument overview
ITEM SPECIFICATION
Program Name Firmware: C51; Adjustment Program: C++;
APP: C#
UDI-DI 04719880129515(E.U.);
04719880129508(U.S.A)
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Please note that this machine is compatible with 220-240Vac
power only. Using wrong power inlet may lead to malfunction
of instrument.
Maelstrom 9600
Front view
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ON/OFF switch
Turntable
rotating buttons
Turntable
The USB port is used
for upgrading HMI
software (human
machine interface).
Use “►” and “◄”
button to rotate
turntable.
⚫Turntable contains 8 plate
holders.
⚫There are four plate
holders (NO.1, NO.2,
NO.3 and NO.6) have the
heating module for
temperature control.
⚫No. 8 plate holder is for
mounting spin tips.
⚫NO.2 to NO.5 plate
holder are allowed to be
selected as ejecting spin
tips.
Maelstrom 9600
Side view
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2. Instrument overview
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The back of Maelstrom 9600 has a USB port for upgrading PLC
software (Programmable Logic Controller), a RS-232 port for barcode
reader connection and an electrical inlet. Please note that the
Maelstrom 9600 needs power supply of 220-240Vac.
Maelstrom 9600
back view
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2. Instrument overview
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Maelstrom 9600
control panel
To initiate the program
To turn off the alarm
To pause the program. Press again to resume the
program.
To turn on/off the LED light.
Emergency to stop machine
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2. Instrument overview
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Before switching on Maelstrom 9600, check the power supply, software
version and the operation.
⚫Please make sure the power supply is 220-240V.
⚫Verify the software version, which should correspond to the datasheet.
⚫Run the demo program to make sure the operations are correct.
Register a user code
After switching on the
instrument and booting,
press square area to enter
the user code or create a
user code.
Please press “New User
Code”for creating a user
code. Use the on-screen
keyboard to enter user
code (max. 12 characters).
Press “ENT”to enter the
new user code.
The new user code will be
shown. Press “Add”to
confirm the new user code.
A B C D E F G H I J K L
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3. Before usage
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Use the on-screen
keyboard to enter the
user code. Press “ENT”
to enter the user code.
Following errors messages might occur.
The error message
“Repeated name”will
appear when the user
entered an existing
user code. Please
choose another user
code.
When a non-existing
user code was entered,
the screen will show
the error message “Not
Found!”. Please enter
the correct user code.
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3. Before usage
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4. Main page
The main page includes several information, including firmware
name, date/time and classification icons.
Firmware name Firmware name of this instrument.
Date and time The date is expressed in the format of YYYY/MM/DD and time is shown in 24-hour
notation.
Spin tips To mount or eject spin tips.
Run To start an experiment.
Reports When experiment was finished, the recorded data will be stored in the reports. Maximum
sets of report is 15.
UV Lamp Turn on or turn off the UV light.
Edit
To edit program, including steps, actions,
temperature control and time. Maximum
steps of one program is 35 and maximum 25
programs can be stored.
Setting To set up language, time, temperature control, factors, barcode and user
management.
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You can mount spin tips by pressing the “Mount”icon and eject spin
tips by pressing the “Eject” icon. Mount and eject actions are fixed in
the plate holder 8 during executing a program.
Step 1. Press “All Home”icon to return the turntable
to the origin. Plate goes to about “2.31”and Mixing / Collect /
Guard Board go to ”0.00”mm.
Step 2. Use “►”and “◄”buttons on the instrument to
move turntable to plate holder 8 for mounting /ejecting spin tips.
Step 3. Press “Mount”icon to mount tips
Step 4. Press “Eject”icon to eject tips
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5. Tips
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2.31
0.00
0.00
0.00
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6. Run
To execute program, you can choose a program by browsing the program
list.
Input by keyboard
Press the number next to the
program name to select
program. Press “Done”to
confirm the selection and go
to next step.
Information of Date, Program
and User will show on top of
underline. Press “Done”to
confirm the information and
go to next step.
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Press blank field next to “Kit
Lot”and “Tip Lot”to enter lot
information. Press “Done”to
confirm the information and
go to next step.
“TANBead Plate”is a reagent kit format using TANBead 96 deep well
plate or TANBead 6-well Auto Tube.
“Non-TANBead”is a reagent kit format using any other compatible
96-well plate rather than TANBead.
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Place the reagent
plates to the
corresponding plate
holder as shown on
the touch screen. Press
“Done”to continue
or ”Back”to go to the
previous page.
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6. Run
Total: 96
Press on the box “A1” (Row A, column 1) to enter the sample ID. After
inputting the sample ID, a blue line will be appeared above the box.
The total number of input sample ID is shown on the top of the table.
When this is completed, press “Done” to continue. If you do not want
to record sample ID, press “Done” directly to go to next step.
Tab the number to
input which plate you
desire to eject tips to.
NO.2 to NO.5 plate
holder are allowed to
be selected as ejecting
spin tips , then press
“Ent”to continue.
2
3
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