TAN Bead Maelstrom 4810 User manual

Maelstrom 4810
User Manual
TAN Bead Nucleic Acid Extractor
(Non-Sterile)
039.M1501.X01Rev V1.0_2021.06.11
(Compatible with power 100V-240V)

1. Introduction ......................................................................................6
2. Instrument Overview ..................................................................11
3. Installation &Get Started ........................................................15
4. On-screen Display &How to Use ........................................16
5. Technical Support ........................................................................36
6. Cleaning and Maintenance ......................................................37
7. Disposal ............................................................................................37
8. Patents ..............................................................................................38
9. About Manufacturer ...................................................................38
10. Appendix .........................................................................................39
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Table of Contents
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The label on the instrument, the User Manual, and other
packaging material may contain following symbols:
About Manual
3
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Catalog number
Serial number
Specification of fuse
Manufacturer
The date of manufacture
An administrative marking that indicates conformity with
health, safety, and environmental protection standards for
products sold within the European Economic Area (EEA)
In Vitro Diagnostic Medical Device
Consult Instructions for Use
Authorized Representative in the European Community
Caution, consult accompanying documents
Hot surface, contact with skin may cause burns
Watch your fingers and your hands
The WEEE symbol, indicating separate collection for WEEE-
Waste of electrical and electronic equipment
Non-Sterile
Temp Limit
(Operating)
Biologic Risks

WARNING
Use a power cord that meets your country’s standard. In case of
any questions about the power cord, contact your local distributor
or reseller.
Do not use the instrument with voltage other than the voltage
specified on the device.
Do not use the instrument with damaged power cord or a loose
socket.
When the power plug is disconnected from the AC outlet, please
hold the power plug itself instead of pulling the power cord.
Before working on maintenance, must disconnect the power plug
from the outlet in advance.
Do not pour any liquid on the instrument.
Do not place any containers with liquid on the instrument. Doing
so may cause a fire, electric shock or malfunctions of the
instrument.
Do not touch the power plug or cord if there is a chance of
lightning. Failure to observe this may cause electric shocks.
If you hear thunder or suspect approaching lightning, quickly turn
off the power switch and pull the power plug from the AC outlet.
Failure to observe this may cause a fire or malfunctions.
About Instrument
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CAUTION
Never attempt to remodel the instrument without the permission
from the manufacturer. Doing so may lead to a fire or electric
shock.
Do not bump or knock the instrument. Doing so may cause
malfunctions.
Repairs to the instrument must be performed by agencies
authorized by Taiwan Advanced Nanotech Inc.
Only original spare parts from Taiwan Advanced Nanotech Inc can
be used on the instrument.
If the equipment is used in a manner not specified by the
manufacturer, the protection given by the instrument may be
impaired or invalid.
About Instrument
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Maelstrom 4810 is an automated nucleic acid platform designed for
mid-to-high throughput applications. Specialized spin tips enable
super mixing efficiency of magnetic beads and larger processing
volume. With intuitive interface and flexible program, Maelstrom
4810 can boost molecular diagnostic laboratory productivity by
transforming routine operations into a walk-away solution.
Operation Principle
Maelstrom 4810 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 4810 shall be used in combination with TANBead
Nucleic Acid Extraction Kit to extract DNA/RNA from specimen.
Maelstrom 4810 can handle magnetic beads for extraction and
purification of nucleic acid.
Please note that this medical device is used by physicians or
medical technologists.
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1. Introduction
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1. Introduction
Environmental Requirements
To avoid shortening of the lifespan of the instrument, use Maelstrom
4810 in a location that meets the following criteria:
•Choose a location that has good air circulation.
•Place Maelstrom 4810 on the table capable of bearing at least the
weight of Maelstrom 4810 (≒ 60 kg).
•Do not use Maelstrom 4810 in a location where there is large
temperature variability or high humidity.
•Suggested operation condition:
Temperature: 10-35℃
Relative humidity: 40-80%
•Storage and transportation condition:
Temperature: 5-60℃
Relative humidity: 20-90%
•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
4810 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, “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
10
1. Introduction
Power cord x1
=Remark=
Power cord varies from region to region.
Tips combo pack x1
Magnetic separator x1 User manual x1
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2. Instrument Overview
ITEM SPECIFICATION
Model Maelstrom 4810
Weight Approx. 60 kg
Dimensions 580(L) x 430(W) x 470(H) mm
Power rating AC100-AC240V, 50/60Hz, 5-2.5A
Fuse 250V, 5A
Max. Throughput 48 samples per run
Process. volume 50μl -1600μl
Spin speed up to 3000 rpm
Heater 12 independent heating blocks
Magnetic rod >3900 gauss
Display 7-inch touchscreen
UV UV-C type, 8W
HEPA E 10 class
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2. Instrument Overview
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HEPA
①Control panel
②Operation area
Front and side view
①Power switch
②Power inlet
③Fuse
③
①
②

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2. Instrument Overview
Control Panel
To turn off the alarm
Emergency to stop machine
Please note that only TANBead technicians and authorized
technicians or service engineers shall engage in program
upgrade.
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Installing Maelstrom 4810 is easy. Please follow the guide below to
correctly set up the instrument.
Please note that this instrument weights around 60kg, it is highly
recommended to have 2 or more persons to handle when taking it
out from the box and must pay attention to the safety.
Step 1:
Take out the instrument from the box (2 or more persons to handle is
highly advised)
Step 2:
Remove the cushions around the instrument
Step 3:
Place the instrument to a flat-table that can bear 100 kg weight
Step 4:
Connect the power. This instrument is compatible with 100-240V
power.
Step 5:
Remove the cushions inside the operation area before turn on the
device.
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3. Installation & Get Started
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4. On Screen Display and How to Use
Enter the user code
An user code is required to access the instrument. The default code is
333. Please keep 333 in the list in case forgetting your own code. You
can create new user code on the setting page. User can only view
their own and default code in code list.
Tab the blank space to
enter the user code.
User
ID
New User
ID
Tab the blue arrow icon to
start the procedure.
* If user code is not existed,
“User code invalid” will
show upon the column
with red color.
You will be leaded to the
main page after the
successful registration.
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4. On Screen Display and How to Use
Main Page
There are six functions that can be used on main page.
To mount and eject spin tips
To execute the extraction program
To export extraction records
To use UV light to clean the instrument
To add/delete/edit/import/export extraction program
To set basic parameter of instrument
TIP
RUN
REPORT
SETTING
Edit
UV light
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Please complete the tip mounting
before you start the extraction
protocol.
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4. On Screen Display and How to Use
Mounting tips. Tab the finger print icon, the tips will be loaded
on the assigned lane which show on the ③.
Ejecting tips. Tab the finger print icon, the tips will be ejected on
the assigned lane which show on the ③. Please be noticed that
the lane you choose to eject the tips should be EMPTY.
Mount/Eject assigned lane. The tips in these lanes will be
mounted/ejected after we act.
LED light. Tab this icon will light up the operation area.
Tip
Tip (Mount and Eject Spin Tips)
②
③
①
④
*Please mount tips separately in each plate site. You will need to
operate tip-mounting function 3 times to complete all 48 tips
mounting.
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4. On Screen Display and How to Use
Tip (incomplete tip-ejecting detection)
Incomplete tip-ejecting could be detected in Maelstrom
4810. When the alarm appear, please check the tip status.
And remember
1. The door should be closed,
2. The plate/autotube should be placed in the right
position.
Incomplete tip-ejecting will cause device damaged. Maelstrom
4810 could detect tip status directly.
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4. On Screen Display and How to Use
Maelstrom 4810 is capable of storing up to 20 programs. Please
follow the guideline of reagent kits and correctly select the
program. Or you could type the key words in the search slot to
save the searching time.
Run function is designed to execute nucleic
acid extraction program stored in the
instrument.
Run
2
1
Kit and Tip lot numbers are not a must for executing the
program, but we highly suggest you to input them for
further tracking. Double tab the Run icon to proceed
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4. On Screen Display and How to Use
Run (Execution of Extraction Program)
L plate R plate
Tab the circle first, and then use on-screen keyboard or USB
barcode scanner to scan in if 1-D barcode is available. Sample
ID can bear 18 characters input. Once completed, tab [Next] to
continue.
The circle will turn red after
the sample ID input
successfully. The input order
will automatically turn to next
number, e.g. A1 will turn to
A2.
Row 1 and 2 stand for the
Well 1 and 7 accordingly of
left plate.
Row 3 and 4 stand for the
Well 1 and 7 accordingly of
middle plate.
Row 5 and 6 stand for the
Well 1 and 7 accordingly of
right plate.
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Step 3: Input sample ID
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