TAN Bead Maelstrom 9610 User manual

Maelstrom 9610
User Manual
TAN Bead Nucleic Acid Extractor
(Non-Sterile)
039.M1602.X01Rev V1.0_2021.06.11
(Compatible with power 100V-120V only)

1. Introduction ......................................................................................6
2. Instrument Overview ..................................................................11
3. Installation &Get Started ........................................................15
4. On-screen Display &How to Use ........................................16
5. Technical Support ........................................................................38
6. Cleaning and Maintenance ......................................................39
7. Disposal ............................................................................................39
8. Patents ..............................................................................................40
9. About Manufacturer ...................................................................40
10. Appendix .........................................................................................41
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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
5
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Maelstrom 9610 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
9610 can boost molecular diagnostic laboratory productivity by
transforming routine operations into a walk-away solution.
Operation Principle
Maelstrom 9610 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 9610 shall be used in combination with TANBead
Nucleic Acid Extraction Kit to extract DNA/RNA from specimen.
Maelstrom 9610 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
9610 in a location that meets the following criteria:
Choose a location that has good air circulation.
Place Maelstrom 9610 on the table capable of bearing at least the
weight of Maelstrom 9610 (≒ 95 kg).
Do not use Maelstrom 9610 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
9610 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.
Auto Tube base is required in use of Auto Tube reagent kits.
Tips combo pack x1
Magnetic separator x1
User manual x1
Auto Tube base x 6
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Transmission cable x1

2. Instrument Overview
ITEM SPECIFICATION
Model Maelstrom 9610
Weight Approx. 95 kg
Dimensions 870(L) x 575(W) x 700(H) mm
Power rating 100-120Vac, 50/60Hz, 8A (Class I)
Fuse 250V, 10A
Max. Throughput 96 samples per run
Process. volume 50μl -1600μl
Spin speed up to 3000 rpm
Heater 4 independent heating plates
Magnetic rod >3900 gauss
Display 7-inch touchscreen
UV & HEPA Available
11
Please note that this machine is compatible with 100-120V power only.
Using wrong power may lead to malfunction or damage to the
instrument.
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2. Instrument Overview
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Turntable
rotating
buttons
Turntable
Use “►” and “◄”
button to rotate
turntable.
Turntable contains 8
plate holders. 4
plate holders
(1,2,3,6) have the
heating module for
temperature control.
The plate holder no.
8 is for mounting
and ejecting spin
tips.
①
②
③
Power Button &
USB I/O
USB type Aport is for the
use of barcode scanner.
USB type B port is for the
connection with PC.
USB type A
USB type B

Rear View
13
2. Instrument Overview
②
③
①USB type A for use of upgrading HMI program
②USB type A for use of upgrading PLC program
③Power inlet
④Fuse
Please note that only TANBead technicians and authorized technicians
or service engineers shall engage in HMI and PLC program upgrade.
①
④
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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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Control Panel

Installing Maelstrom 9610 is easy. Please follow the guide below to
correctly set up the instrument.
Please note that this instrument weights around 95kg, it is highly
recommended to have 3 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 (3 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 120kg weight
Step 4:
Connect the power. Please note that this instrument is compatible with
100-120V power only. Using wrong power source will lead to malfunction
or damage to the instrument.
Step 5:
Power on the instrument and it will perform initialization. Once
initialization is done, please remove Y-axis protector from the instrument
and the instrument is ready to use.
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3. Installation & Get Started
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Y-axis protector

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4. On Screen Display and How to Use
Create an User ID
An user ID is required to access the instrument. For a brand new
machine, there is a need to create an user in advance. Click the icon
to create your own user ID.
Tab the icon to
create a new user ID
Click blank space to
call out keyboard
Use the keyboard to input user
ID and then click [Enter] to save
and exit
User ID: max. 12 characters
CK1975
User
ID
New User
ID
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4. On Screen Display and How to Use
Save User ID
After creating the user ID, please must click to save and then
program will automatically lead you access the system.
Instrument is trying to
save new user ID
After save, you will be
guided to the main
page. Now you can
prepare for extraction
work.
Switch user
To switch user, there is no need to power off/on the
instrument. Take advantage of icon to switch user
quickly.
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Possible Error Message
Some messages may occur when you try to log in or create an user
ID.
User ID not found
Make sure you
input correct,
existing user ID
account
4. On Screen Display and How to Use
User ID repeated
Please change the
name of creating an ID
Account is full
Max. 24 user ID are
allowed. If the
account is full, please
contact the dealer
nearest to you for
further help.
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Main Page
There are six functions that can be used on main page.
To test on mounting and ejecting spin tips
To execute the extraction program
To export extraction records
To use UV & HEPA to sterilize the instrument
To edit, add, and delete extraction program
To set basic parameter of instrument
TIP
RUN
REPORT
PROGRAM
SETTING
STERILIZE
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4. On Screen Display and How to Use

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Tip Point (Setting): Parameter setting value upon mounting tips
Tip Point (Actual): Actual tip-mounting parameter value
Eject Tip Point (Setting): Parameter setting value upon ejecting tips
Eject Tip Point (Actual): Actual tip-ejection parameter
4. On Screen Display and How to Use
Tip function is designed to test the
performance of mounting and ejecting
spin tips.
=Remark=
Actual value needs to equal to Setting value
Tip
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Tip (Test on Mount and Eject Spin Tips)