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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. Miracle-AutoXT System Specification

Section Ⅰ. Miracle-AutoXT System Requirements

Section Ⅱ. Product Components

Section Ⅲ. Precautions

Section Ⅳ. Installation

1. Unpacking Miracle-AutoXT System

2. Installing Miracle-AutoXT System

3. Hardware Overview

4. Switching on the Miracle-AutoXT System

Section Ⅴ. Miracle-AutoXT System User Interface

1. User interface home screen
2. Plate set up
3. Strip set up
4. Implementation of Miracle-AutoXT System
5. UV lamp time setting
6. Preheating
7. Test mode
8. Error code
9. Software update

10. Other information

Section Ⅵ. Trobleshooting

Section Ⅶ. Warranty

Section Ⅷ. Symbols

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.

Summary of Contents for Miracle-AutoXT

Page 1: ...action System as an in vitro diagnosis IVD purpose File no IBT QMS INT50104 R00 Date 2017 06 01 Version Rev 0 0 These documents are the property of iNtRON Biotechnology Inc and shall not be reproduced...

Page 2: ...witching on the Miracle AutoXT System Section Miracle AutoXT System User Interface 1 User interface home screen 2 Plate set up 3 Strip set up 4 Implementation of Miracle AutoXT System 5 UV lamp time s...

Page 3: ...Instruction for Use USER MANUAL IBT QMS INT50104 R00 3 34 Section 0 Introduction...

Page 4: ...tem based on magnetic bead separation technology For DNA RNA isolation process 96 well plate or individual strip containing magnetic beads should be set up into the instrument and then the instrument...

Page 5: ...Instruction for Use USER MANUAL IBT QMS INT50104 R00 5 34 Section I Miracle AutoXT System Requirement...

Page 6: ...e is any other specific notice or indication Safety voltage Please make sure that the range of voltage is as follow Input voltage 110 240V Power requirements 50 60Hz 2 5A Environmental requirements Te...

Page 7: ...Instruction for Use USER MANUAL IBT QMS INT50104 R00 7 34 Section II Product Components...

Page 8: ...check and inspect the package carefully to make sure that all components Miracle AutoXT System instrument are included prior to use Miracle AutoXT Nucleic Acid Extraction System Power cable Instructio...

Page 9: ...Instruction for Use USER MANUAL IBT QMS INT50104 R00 9 34 Section III Precautions...

Page 10: ...not place any device that might be affected by vibration Do not place any device that produce vibration or heat besides Miracle AutoXT System Do not install and or store the device in dusty place Do...

Page 11: ...y inserted in their correct positions and orientation Failure to do so may result in damage to the instrument Before operation the system check magnetic rod position Use the switch in order to shut of...

Page 12: ...is heated automatically upon activation of the device It may cause skin burn if touched with any part of body Do not touch Heating Tray directly when the device is activated at any circumstance Pleas...

Page 13: ...Instruction for Use USER MANUAL IBT QMS INT50104 R00 13 34 Section IV Installation...

Page 14: ...cle AutoXT System is intact If anything is damaged contact Technical service team Do not use defected devices The power supply should be switched off unless operational Remove the fixture Warring Risk...

Page 15: ...mpletely before operation 3 Remove another fixture located at the bottom of the device as marked in Figure 3 above Be cautious not to damage the device Figure 4 Adjust horizontality by turning the rub...

Page 16: ...e of the instrument not to disturb the operation Do not use near flammable gases or liquids Locate a minimum clearance 10cm at the sides and rear of Miracle AutoXT System 3 Hardware Overview External...

Page 17: ...f Switch For the extraction experiments start and shut down button is used which is located next to the touchscreen of front side on the upper right side Figure 8 Start Shut down botton Magnetic Rod a...

Page 18: ...Instruction for Use USER MANUAL IBT QMS INT50104 R00 18 34 Section V Miracle AutoXT System User Interface...

Page 19: ...10 Home screen window 2 Plate set up example 96 plate well type The exclusive 96 well plate must be set by following the instructions 1 Open the front door and pull the heating tray to set 96 well pla...

Page 20: ...nstrument damages Warring Risk of material damage Ensure that the 96 well plate is located into the correct position of the heating tray Figure 11 Correct and incorrect way of inserting plate on heati...

Page 21: ...ect and incorrect way of inserting strip in the device Strip shall be pushed until the end of the strip holder Push strip until Click sound is heard Strip and or magnetic rod may break and cause malfu...

Page 22: ...cedure screen It will be started automatically and indicates the remaining time on the screen Refer to Figure 16 After completion it gives a beep You can check the progress of step on window of touchs...

Page 23: ...evice when it s operational at any circumstances Insert and remove plate and strip only when the device is not operational Do not touch any internal part of the device at any circumstances 4 Alarm rin...

Page 24: ...graph LCD screen gives a warm up period with warning signs and you can begin driving after all this time has elapsed Turn on the device 10 minutes before operation to preheat heating blocks Turning on...

Page 25: ...ch shorter than regular test mode and remaining time is displayed on LCD screen Refer to figures 20 and 21 below Figure 20 Home screen Menu selection Figure 21 Test mode procedure screen 8 Error code...

Page 26: ...to restart the test with new kit otherwise data may be compromised 1 Start fixing the device with fixtures 15 minutes after deactivation to avoid any skin burn from heated heating blocks 2 Lift inner...

Page 27: ...Instruction for Use USER MANUAL IBT QMS TF 001 R00 27 34 Section VI Troubleshooting...

Page 28: ...plugged in Check the fuse connection next to the power cord Contact the local distributors or technical service team In case of motor works Touch LCD could be disconnected from the power or out of ord...

Page 29: ...is not working properly Check whether Whole blood button in home screen is pressed Improper extraction result may derive if processed by test mode Check whether plate and strip are properly placed Ma...

Page 30: ...Instruction for Use USER MANUAL IBT QMS INT50104 R00 30 34 Problem Possible caused and comments Error code 3 RS 232 Serial Error Error code 4 Temperature Sensor Error Error code 5...

Page 31: ...Instruction for Use USER MANUAL IBT QMS TF 001 R00 31 34 Section VII Warranty...

Page 32: ...arises after the limited warranty period shipping and handling charge may apply to any repair or exchange of the product undertaken by iNtRON Biotechnology Exclusion and limitation This warranty does...

Page 33: ...Instruction for Use USER MANUAL IBT QMS TF 001 R00 33 34 Section VIII Symbols...

Page 34: ...stic Medical device Use by Synonym for this Expiry Date Batch code Synonym for this are Lot Batch Number Catalogue Number Attention See Instruction for use Temperature Limitation Upper Limit of Temper...

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