TAN Bead Maelstrom 9610 Manual de usuario

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

Table of Contents

ENGLISH

The label on the instrument, the User Manual, and other

packaging material may contain following symbols:

About Manual

ENGLISH

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

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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.

1. Introduction

ENGLISH

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

ENGLISH

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.

1. Introduction

ENGLISH

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

1. Introduction

ENGLISH

Please note that following accessories accompanying with

instrument may vary from region to region.

Equipment list

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

ENGLISH

Transmission cable x1

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