TAN Bead Maelstrom 8 Autostage User manual

TANBead Nucleic Acid Extraction
System (non-sterile)
039.M0101.X01 Rev V1.0_2021.01
Maelstrom 8
Autostage
User Manual

1. Introduction …………..…………………...……………………. 4
2. Instrument Overview …..……..................................……. 9
3. Before Usage …………..………………….……………...…... 12
4. Attention of Installing Spin Tips ….................……... 13
5. Home Page ….............................................................…... 14
6. Guide ................................................................................... 17
7. Manual ............................................................................... 18
8. Edit ....................................................................................... 20
9. Setting ……............................................………….....……… 28
10. Error Message ................................................................. 31
11. Cleaning & Maintenance ........................................... 33
12. Disposal ……...............................……………...….….……… 33
13. Patent Info ……...............................………….….…….…… 34
14. Manufacturer …….........................………….…..…….…… 34
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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 the following symbols.
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Catalog number
Serial number
Specification of fuse
Manufacturer
The date of manufacture
This product fulfills the requirements of the
European Directive
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
About this manual
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1. Introduction
Magnetic rotary mixer is a magnetic bead handling device with high
speed stirring function, which can spin up to 3000 rpm. With eight
magnetic rods, intuitive interface and simple operation, it can
accomplish any application of magnetics beads. It works alone with
Autostage to form an automated solution, called Maelstrom 8
Autostage.
Operation Principle
Maelstrom 8 Autostage 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 8 Autostage can be used in combination with TANBead
Nucleic Acid Extraction Kit to extract DNA/RNA from specimen.
This medical device is used by physicians or medical technologists.
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1. Introduction
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Environmental Requirements
⚫Choose a location with good air circulation
⚫Place this instrument on a table that can bear the weight 15 kg.
⚫Do not use this instrument 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 8
Autostage does not exceed 65 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.
1. Introduction
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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 61010-2-101:2015, “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
1. Introduction
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Magnetic rotary mixer x1
Power cord plug may vary from region to region
Spin tips x8
Autostage x1 Transmission cable x1
What’s in the Box
Please note that following accessories accompanying with
instrument may vary from region to region.
User manual x1
Power cord & adapter x1
1. Introduction
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Charging indicator
MENU button (M) ROD button (R)
Click wheel
Tips ejector
Spin shaft
Charging port (Micro USB)
Reset button
Mini USB
Finger hook
ENTER button
Mixing trigger
2. Instrument Overview
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ITEM SPECIFICATION
Model Name Magnetic rotary mixer
Weight 600 g
Dimensions 112(W)x327(H)x63(D)mm
Power 5 Vac, 2 A
Battery 3.7 Vac , 2850mAh
Throughput 8 samples per run
Pro. volume 50 μl ~ 1500 μl
Spin Speed up to 3000 rpm
Magnetic rod >3000 gauss
Display 2.4” LCD, 240 x 320 pixels
2. Instrument Overview
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ITEM SPECIFICATION
Model Autostage
Weight 9.6 kg
Dimensions *357(W)x285(H)x190(D)
mm
Power 19 Vac, 120 W
Heater 1 heating block
Micro USB (For program update)
Type A USB (For charging rotary mixer)
Mini USB
(For communication with rotary mixer)
Emergency stop switch
Operation module
Heater switch
Power switch
Power socket for 19V adapter
* Without cover open
2. Instrument Overview
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Each magnetic rotary mixer is set into shipping mode before it’s
delivered, there’s a need to unlock the shipping mode before first
use. Once it is plugged in, the shipping mode will be unlocked.
Unlock Shipping Mode & Set up Maelstrom 8 Autostage
⚫Connect the magnetic rotary mixer with Autostage via
transmission cable
⚫Plug the Autostage to the power (19V adapter required)
⚫Power on magnetic rotary mixer to unlock shipping mode, and
followed by Autostage
⚫Go to Setting\System Param Setting to enable & apply “Stand
Connection”
Transmission Cable
⚫Side I: Micro USB and Mini USB
◼Micro USB to charging port of magnetic rotary mixer
◼Mini USB to Mini USB port of magnetic rotary mixer
⚫Side II: Mini USB and Type A USB
◼Mini USB to Autostage communication port
◼Type A USB to Autostage Type A USB port
Magnetic Rotary Mixer
⚫When the rotary mixer is being charged, the
charging indicator will turn orange.
⚫Battery power will decrease slowly even the
rotary mixer is not being used.
⚫DO NOT disassemble the magnetic rotary
mixer
⚫Pressing MENU to power on or turn off the
device
3. Before Usage
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4. Attention of Installing Spin Tips
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When installing spin tips on magnetic rotary mixer, please
pay attention to following requirement.
⚫When mount the tips on magnetic rotary mixer, make sure the
leading edge of spin shaft is as close as possible to the bottom of
sleeve. Too much interspace will lead to abnormal operation.
Spin Shaft

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5. Home Page
From Main page, user can choose Guide mode or Manual mode to
operate the rotary mixer. To edit programs, please enter Edit page.
To set up system parameter, such as beep sound, auto-off, time and
date, please go to Setting page. Further system information can be
found in Setting page.
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5. Home Page
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Functional Keys –MENU button
1) Press MENU button to power on the magnetic rotary mixer
2) Press MENU button for 3 seconds to power off the magnetic
rotary mixer
3) During the operation, press MENU button once to interrupt the
experiment and then follow the prompt message to press
second time to cease the operation.
4) User can return to main page without saving changes by
pressing MENU button twice.
Functional Keys –ROD button
1) In Manual mode, press ROD button to extend or withdraw the
magnetic rods.
2) In Edit page, press ROD button to switch the input method

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5. Home Page
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Functional Keys –ENTER button
1) In Guide mode, press ENTER to start the protocol selected.
2) During the extraction process, press ENTER once to pause the
operation. Then, press ENTER second time to resume the
operation.
3) In Manual mode, press ENTER to start the mixing.
4) In Edit page, in each field, press ENTER to start to modify the
parameter value of field.
5) To save the parameter value, use click wheel to move the cursor
to SAVE and press ENTER to save.
Functional Keys –Click Wheel
1) Click wheel is mainly used to move cursor to different fields of
Edit page.
2) In Manual mode, press up/down of click wheel to speed
up/down the spin speed.
3) In Edit page, press up/down of click wheel to adjust the
parameter value set in the field.

6. Guide
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Pre-installed Programs
On each magnetic rotary mixer, there are several programs pre-
installed before it is shipped from the manufacturing plant. Use the
click wheel to choose desired program for the experiment.
Know the Icons
In the course of experiment, the display screen will automatically
switch icons to represent current state of experiment. Knowing those
icons is important.
Mixing Beads
Collecting Vapor Finish of Protocol

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7. Manual
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For the operation without using Autostage
User can do the nucleic acid extraction without using Autostage. In
this case, manual mode shall be applied.
How to do the extraction manually
For manually extraction, there is no need to use Autostage.
Mixing –Manual Operation
1) Mount the tips to magnetic rotary mixer (tips combo pack
required)
2) Insert it to the 96 deep well plate and press ENTER button to start
mixing. User can press up/down of click wheel to accelerate or
decelerate the spin speed. In addition, user can press left/right of
click wheel to alter the spin direction.
3) Press the ENTER button to cease mixing
To alter spin
direction
To speed up/
down spin speed

7. Manual
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For the operation without using Autostage
User can do the nucleic acid extraction without using Autostage. In
this case, manual mode shall be applied.
How to do the extraction manually
For manually extraction, there is no need to use Autostage.
Beads Collecting –Manual Operation
1) Raise magnetic rotary mixer off the plate and press ROD button
to extend magnetic rods
2) Slowly move down to plate well and beads will be collected on
the leading edge of spin tips
3) Raise the mixer off the plate and slowly move to targeted plate
wells
4) Submerge the spin tips with collected beads in the solution
buffer and then press ROD button to withdraw magnetic rods.
After withdraw rods, beads will be released in the solution buffer.
Then, repeat mixing for binding.

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8. Edit
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Editing Protocol
There are some pre-installed programs on magnetic rotary mixer.
User can freely edit them on either rotary mixer or by importing a
program file.
How to import a program file to magnetic rotary mixer
1. Link the rotary mixer with the PC by the transmission cable.
» Type A USB to the PC
» Micro USB to the charging port of magnetic rotary mixer
Micro USB
Type A USB
2. Power on the rotary mixer
3. Go to Windows Explorer and navigate Computer, then find “USB
Drive” where you will see all pre-installed files.
4. Copy and paste targeted file (*.csv) to the USB Drive
The *.csv file name MUST be a 2-digit number (ex. 01~50)