iNtRON Miracle-AutoXT User manual

Instruction for Use
USER MANUAL
IBT-QMS-INT50104 (R00)
1/34
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.

Instruction for Use
USER MANUAL
IBT-QMS-INT50104 (R00)
2/34
- 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.

Instruction for Use
USER MANUAL
IBT-QMS-INT50104 (R00)
3/34
Section 0. Introduction

Instruction for Use
USER MANUAL
IBT-QMS-INT50104 (R00)
4/34
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

Instruction for Use
USER MANUAL
IBT-QMS-INT50104 (R00)
5/34
Section I. Mirac e-AutoXT System Requirement

Instruction for Use
USER MANUAL
IBT-QMS-INT50104 (R00)
6/34
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

Instruction for Use
USER MANUAL
IBT-QMS-INT50104 (R00)
7/34
Section II. Product Components

Instruction for Use
USER MANUAL
IBT-QMS-INT50104 (R00)
8/34
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

Instruction for Use
USER MANUAL
IBT-QMS-INT50104 (R00)
9/34
Section III. Precautions

Instruction for Use
USER MANUAL
IBT-QMS-INT50104 (R00)
10/34
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.