iNtRON Miracle-AutoXT User manual

Instruction for Use
USER MANUAL
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Miracle-AutoXT
Nuc eic Acid Extraction System
Automated Nucleic Acid Extraction System,
as an in vitro diagnosis(IVD) purpose
Fi e no.
IBT-QMS-INT50104(R00)
Date
2017. 06. 01
Version
Rev 0.0
These documents are the property of iNtRON Biotechno ogy, Inc. and sha not be reproduced, distributed, disc osed or
used for manufacture or sa e of apparatus without the express written consent of iNtRON Biotechno ogy, Inc.

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- INDEX -
Section 0.
Introduction
1.
Product Intended Use
2.
Product Description
3.
Product Characteristics
4.
Mirac e-AutoXT System Specification
Section Ⅰ .
Mirac e-AutoXT System Requirements
Section Ⅱ .
Product Components
Section Ⅲ .
Precautions
Section Ⅳ .
Insta ation
1.
Unpacking Mirac e-AutoXT System
2.
Insta ing Mirac e-AutoXT System
3.
Hardware Overview
4.
Switching on the Mirac e-AutoXT System
Section Ⅴ .
Mirac e-AutoXT System User Interface
1.
User interface home screen
2.
P ate set up
3.
Strip set up
4.
Imp ementation of Mirac e-AutoXT System
5.
UV amp time setting
6.
Preheating
7.
Test mode
8.
Error code
9.
Software update
10.
Other information
Section Ⅵ .
Trob eshooting
Section Ⅶ .
Warranty
Section Ⅷ .
Symbo s
This user manual introduces Miracle-AutoXT System instrument and protocol.
It contains the specification for Miracle-AutoXT System.
Before using the Miracle-AutoXT System, it is essential that you read this user manual carefully especially for
Safety Information.

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Section 0. Introduction

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1. Product Intended Use
The Mirac e-AutoXT System instrument is intended for use, in combination with the series of
Mirac e-AutoXT Extraction kits, as an in vitro diagnostic (IVD) purpose to perform automated iso ation of
nuc eic acid from samp es.
Mirac e-AutoXT system is not intended for use as part of a specific in vitro diagnostic test. It is intended
for professiona use on y. Diagnostic resu ts obtained using the nuc eic acids purified with this system
must be interpreted in conjunction with other c inica or aboratory data.
The automated steps performed by Mirac e-AutoXT System instrument inc ude:
Ÿ Samp e ysis and washing
Ÿ Binding of nuc eic acids to magnetic beads
Ÿ E ution of the product
2. Product Description
Mirac e-AutoXT System instrument is an automated nuc eic acid purification system based on magnetic
bead separation techno ogy. For DNA/RNA iso ation process, 96 we p ate or individua strip
containing magnetic beads shou d be set up into the instrument and then the instrument wi perform
the process for ysis, washing and e ution automatica y. This automated extraction system enab es you to
extract high qua ity of nuc eic acids from samp es by using magnetic force of Mirac e-AutoXT magnetic
rod in the system.
3. Product Characteristics
Ÿ System contro and test imp ementation through LCD touch screen (No PC or tab et needed)
Ÿ UV ight to aid in sanitizing the instrument
Ÿ Easy-to-use system (app ication of optima protoco s for DNA, RNA extraction)
Ÿ Preprogramed protoco for nuc eic acid purification
Ÿ High efficiency of nuc eic acids purification
Ÿ Minimize the hands on time
Ÿ Up to 32 samp es in a sing e run
4. Miracle-AutoXT ystem pecification
Ÿ Processing time: 15-20 minutes
Ÿ Number of samp es: up to 32
Ÿ Standard configuration: 100 u e ution vo ume
Ÿ Weight: 24 kg (52.9 b)
Ÿ Dimensions (W x D x H): 3 40 x 420 x 345mm (13.9 x 16.5 x 13.6 inches

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Section I. Mirac e-AutoXT System Requirement

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The system requirements are app ied in genera condition at room temperature (25 ℃ ) if there is any other
specific notice or indication.
afety voltage
P ease make sure that the range of vo tage is as fo ow.
Ÿ Input vo tage 110-240V
Ÿ Power requirements 50-60Hz, 2.5A
Environmental requirements
Ÿ Temperature
Operation
10 ~ 40 ℃
Storage
10 ~ 50 ℃
Ÿ Humidity
Operation
10 ~ 80% RH, Noncondensed
Storage
10 ~ 80% RH, Noncondensed
Ÿ Maximum a titude
2000m
Ÿ Use indoor

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Section II. Product Components

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P ease check and inspect the package carefu y to make sure that a components
Mirac e-AutoXT System instrument are inc uded prior to use
Mirac e-AutoXT Nuc eic Acid Extraction System
Power cab e & Instruction for use
Figure 1. Components of Mirac e-AutoXT System instrument

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Section III. Precautions

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Please make sure to read the precautions for correct use of the product.
Ÿ Do not use the Mirac e-AutoXT System instrument with vo tage(110~240V ± 10%, 50~60Hz) other than
the vo tage specified on the device.
Ÿ Do not use the Mirac e-AutoXT System instrument with a damaged power supp y or oose socket.
Ÿ P ease keep the instrument on a f attened surface and provide minimum of a feet at every side of
the device for air circu ation.
Ÿ Strong impact on the instrument may cause severe damage and thus ma function.
Ÿ Do not connect mu tip e devices to a sing e wa out et. The oad may cause an over oad and fire.
Ÿ Mirac e-AutoXT System vibrates when activated. Do not p ace any device that might be affected by
vibration.
Ÿ Do not p ace any device that produce vibration or heat besides Mirac e-AutoXT System.
Ÿ Do not insta and/or store the device in dusty p ace
Ÿ Do not insta and/or store the device near heat sources.
Ÿ Do not insta and/or store the device near water or moist p ace
Ÿ Do not attempt to change or modify the instrument without iNtRON permission.
Ÿ Do not try to connect the power p ug with wet hands.
Ÿ This automated nuc eic acid purification system is exc usive y optimized to use in combination with
the Mirac e-AutoXT Extraction reagents. Do not attempt to use any other brand of the kit or reagents.
Ÿ P ease make sure that pre-fi ed 96 we p ate or pre-fi ed individua strip is set correct position onto
the heating p ate.
Ÿ Do not disassemb e unit. It may cause fire, e ectrica shock and ma function. The warranty sha not
be guaranteed if disassemb ed.

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Ÿ Do not use this instrument with any purpose other than its intended use.
Ÿ Do not pour any iquid on the Mirac e-AutoXT System instrument.
Ÿ Do not p ace near other vibration sensitive instruments.
Ÿ The front door must be c osed during the operation of instrument.
Ÿ Do not operate the instrument in the p ace near f ammab e gases or iquids.
Ÿ Dispose UV bu b in accordance with country, federa , state and oca regu ations since it contains
mercury.
Ÿ Disconnect the power before c eaning or performing routine maintenance.
Ÿ There is a possibi ity to be exposed by UV rays due to the UV amp of instrument. Do not turn on
the UV amp un ess comp ete y c ose the front door.
Ÿ Ensure strips and p ates have been secure y inserted in their correct positions and orientation. Fai ure
to do so may resu t in damage to the instrument.
Ÿ Before operation the system, check magnetic rod position.
Ÿ Use the switch in order to shut off the power supp y.
Ÿ Do not operate the system if ma function is expected.
Ÿ LCD screen is a touch pane . S ight and soft finger touch wi activate the LCD screen. Sharp too s
such as knife, Nai or pen may damage the LCD.
Ÿ This instrument is intended for use with human-derived samp es. Use appropriate persona protective
equipment (i.e-g oves, safety gogg es, ab coat, etc.) for hand ing and disposing of biohazardous
materia s.
Ÿ Keep hands c ear of instrument p atform as it moves in and out of the instrument.
Ÿ Keep the surface of instrument c ean.
Ÿ When there is any sign of fire (Smoke, burning sme etc) during device operation or stand-by mode
stop the operation immediate y and disconnect the power cab e from the unit, and then contact
customer service or manufacturer.

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Ÿ The device sha be steri ized with UV amp at a time. Do not ook or touch UV amp direct y. It
may eyes or skin.
Ÿ If the device is stained by reagent, samp e or dirt disinfects it with 70% Ethano when the device is
comp ete y turned off.
Ÿ Heating Tray is heated automatica y upon activation of the device. It may cause skin burn if
touched with any part of body. Do not touch Heating Tray direct y when the device is activated at
any circumstance.
Ÿ P ease discard used p ate and strip in bio-hazard disposab e container.
Ÿ If any part of body, especia y eye is exposed to reagents direct y wash with running water and go
to hospita immediate y.
Ÿ The Mirac e-AutoXT System is not recyc ab e. P ease contact customer service or manufacturer upon
disposa of the device.

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Section IV. Insta ation

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1. Unpacking Miracle-AutoXT ystem
Li iF � Mirac e-AutoXT 32 is operated by step motor which is movab e. Therefore, it is fixed and
de ivered to prevent instrument damages.
Warring
Risk of personal injury and material damage
Ensure that the fixture must be removed before connecting the power
Cut and remove the any tapes or straps around the box to open the shipping box.
Check whether Mirac e-AutoXT System is intact. If anything is damaged contact Technica service team.
Do not use defected devices. The power supp y shou d be switched off un ess operationa .
Remove the fixture
Warring
Risk of personal injury and material damage
Ensure that the main power must be switched off before re ease the fixture
Figure 2. Remove the fixture
1
Two fixtures, one inside and one at the bottom, ho d magnetic rod tight to prevent
damage during shipment.
2
Open the cover and remove fixture marked red in Figure 2 above. If magnetic rods and
ho der are ocated c ose to the fixture ift them one by one unti you have enough space
to turn the fixture.

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Figure 3. Remove the fixture (bottom view)
Warring
Risk of material damage
If the device is operated without removing both fixtures it won't start with
ratt ing sound. It may cause severe damage to the device, hence sha be
removed comp ete y before operation.
3
Remove another fixture ocated at the bottom of the device as marked in Figure 3 above.
Be cautious not to damage the device.
Figure 4. Adjust horizonta ity by turning the rubber feet (bottom view)
4
Horizonta ize the device using rubber feet as shown in Figure 4 above.
2. Installing Miracle-AutoXT ystem
Mirac e-AutoXT System instrument is intended for indoor use on y.
Before insta ing Mirac e-AutoXT System, insta in a ocation that meets the fo owing criteria:

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Ÿ Locate on a sturdy, eve surface
Ÿ Avoid dusty areas
Ÿ Do not p ace near generated heat
Ÿ Locate out of direct sun ight, away from heat sources
Ÿ Away from sources of vibration and e ectrica interference
Ÿ Do not connect a arge number of powers into an out et. It can be a reason of fire.
Ÿ Do not eave any things at front side of the instrument not to disturb the operation
Ÿ Do not use near f ammab e gases or iquids
Ÿ Locate a minimum c earance 10cm at the sides and rear of Mirac e-AutoXT System
3. Hardware Overview
External features
Front View
Rear View
Figure 5. Externa feature of Mirac e-AutoXT System
Internal features
Interna View I
Interna View II
Figure 6. Interna feature of Mirac e-AutoXT System
4. witching on the Miracle-AutoXT ystem
After connecting the instrument to a power out et, you can switch on the instrument. The power switch
is ocated on the back of the instrument. (Figure 3)

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Figure 7. On/Off Switch
For the extraction experiments, start and shut down button is used which is ocated next to the
touchscreen of front side (on the upper right side).
Figure 8. Start/Shut down botton
Magnetic Rod automatica y moves to its origina position upon activation of the device

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Section V. Mirac e-AutoXT System User Interface

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1. User interface home screen
The start-up screen page is showed up on touchscreen and initia izes the sensors after switching on the
instrument.
Figure 9. Initia izing screen window
If everything is comp eted and has no prob ems, then main home screen wi be appeared as be ow.
Figure 10. Home screen window
2. Plate set up (example, 96 plate well type)
The exc usive 96 we p ate must be set by fo owing the instructions
1
Open the front door and pu the heating tray to set 96 we p ate for test
Warring
Risk of injury and material damage
Be cautious not to get finger caught between the door and the heating tray
when pu ing/pushing heating tray. Excessive force app ied may damage
user's finger and the instrument. Open the door s ow y. Otherwise, it may
damage the instrument.
2
Insert the p ate on the ho e of heating p ate

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3
Push the heating tray into the instrument for ready to operating. Ensure that the tray has
been inserted to the end in order to avoid instrument damages.
Warring
Risk of material damage
Ensure that the 96 we p ate is ocated into the correct position of the
heating tray.
Figure 11. Correct and incorrect way of inserting p ate on heating tray
If it is inserted incorrect y or upside down it may cause operating error and extraction may not work.
Figure 12. Correct and incorrect way of inserting p ate on heating tray in the device