Megafuge 8 Instruction Manual Feb 2013

Thermo Scientific

Heraeus Megafuge 8 Centrifuge Instruction Manual 50138896-a

February 2013

© 2013 Thermo Fisher Scientific Inc. All rights reserved. Delrin, TEFLON, and Viton are registered trademarks of DuPont. Noryl is a registered trademark of SABIC. POLYCLEAR is a registered trademark of Hongye CO., Ltd. Hypaque is a registered trademark of Amersham Health As. RULON A and Tygon are registered trademarks of Saint-Gobain Performance Plastics. Alconox is a registered trademark of Alconox. Ficoll is a registered trademark of GE Healthcare. Haemo-Sol is a registered trademark of Haemo-Sol. Triton X-100 is a registered trademark of Sigma-Aldrich Co. LLC. All other trademarks are the property of Thermo Fisher Scientific Inc. and its subsidiaries. Thermo Fisher Scientific Inc. provides this document to its customers with a product purchase to use in the product operation. This document is copyright protected and any reproduction of the whole or any part of this document is strictly prohibited, except with the written authorization of Thermo Fisher Scientific Inc.

Country of Origin (manufacturer): Thermo Fisher (Suzhou) Instruments Co., Ltd. No. 297 Taishan Road, New District, Suzhou, Jiangsu P. R. China Importer for Europe (authorised representative): Thermo Electron LED GmbH Robert-Bosch-Straße 1 D - 63505 Langenselbold Germany The contents of this document are subject to change without notice. All technical information in this document is for reference purposes only. System configurations and specifications in this document supersede all previous information received by the purchaser. The pictures published within this manual are for reference only. The values shown on your centrifuge might differ. Thermo Fisher Scientific Inc. makes no representations that this document is complete, accurate or errorfree and assumes no responsibility and will not be liable for any errors, omissions, damage or loss that might result from any use of this document, even if the information in the document is followed properly.

This document is not part of any sales contract between Thermo Fisher Scientific Inc. and a purchaser. This document shall in no way govern or modify any Terms and Conditions of Sale, which Terms and Conditions of Sale shall govern all conflicting information between the two documents.

Original instruction manual 50138896-a printed in February 2013.

WEEE Compliance This product is required to comply with the European Union’s Waste Electrical & Electronic Equipment (WEEE) Directive 2002/96/EC. It is marked with the following symbol:

Thermo Fisher Scientific has contracted with one or more recycling or disposal companies in each European Union (EU) Member State, and these companies should dispose of or recycle this product. See www.thermo.com/rohsweee for further information on Thermo Fisher Scientific’s compliance with these Directives and the recyclers in your country.

Contents

Preface

...9

Items Supplied... 9 Intended Use... 9 Precautions

... 11

Introduction and Description... 15 Characteristics... 16 Technical Data... 17 Directives, Standards and Guidelines... 18 Functions and Features... 19 Mains Supply... 19 Rotor Selection... 20 Before Use

... 21 Before Setting up... 22 Location... 22 Transporting the Centrifuge... 23 Aligning the Centrifuge... 23 Mains Connection... 24 Storage... 24 Shipping the Centrifuge... 25

Control Panel... 27 Control Panel... 28 Keys... 28 Operation

... 29 Switch on Centrifuge... 30 Open Lid... 30 Close Lid... 30 Rotor Installation... 31 Entering Parameters... 32 Programs... 34 Centrifugation... 35 Short-term Centrifugation... 37 Removing the Rotor... 37 Aerosol-tight Rotors... 38 Aligning the Centrifuge... 38

System Menu... 39 Description... 41

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Contents

Maintenance and Care... 45 Cleaning Intervals... 46 Cleaning... 46 Disinfection... 48 Decontamination... 49 Autoclaving... 50 Thermo Fisher Scientific Service... 50 Disposal

... 51

Troubleshooting... 53 Mechanical Emergency Door Release... 54 Troubleshooting by Guide... 55 When to Contact Customer Service... 57 Chemical Compatibility Chart... 59 Contact

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Preface Before starting to use the centrifuge, read through this instruction manual carefully and follow the instructions. The information contained in this instruction manual is the property of Thermo Fisher Scientific; it is forbidden to copy or pass on this information without explicit approval. Failure to follow the instructions and safety information in this instruction manual will result in the expiration of the sellers warranty.

Items Supplied Item

Quantity

Thermo Scientific Heraeus Megafuge 8 Centrifuge

1

Power supply cable

1

Instruction manual

1

Check

If any parts are missing, please contact your nearest Thermo Fisher Scientific representative.

Intended Use This centrifuge is a laboratory product used to separate substance mixtures of different densities. This centrifuge can become an In-vitro-diagnostics device (Directive 98/79/EC), if used together with the hematocrit rotor and his accessories. The hematocrit value is determined using the instructions written in the instruction manual of the hematocrit rotor. The instructions are based upon the reference method following DIN 58933, allowing to determinate the erythrocyte volume fraction within the blood. This centrifuge has to be operated by trained specialists only.

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Preface

Symbols used on the centrifuge This symbol refers to general hazards. Follow the instructions in the instruction manual in any case.

This symbol refers to biological hazards.. Observe the information contained in the instruction manual to keep yourself and your environment safe. This symbol refers to information on hazards, described within the manual.

This symbol refers to disconnect mains before transporting or servicing the centrifuge.

This Symbol refers to check, if the rotor is installed correct by lifting it slightly at the handle. See “Rotor Installation” on page 31.

Symbols used in the manual Observe the information contained in the instruction manual to keep yourself and your environment safe. This symbol refers to general hazards. CAUTION means that material damage could occur. WARNING means that injuries or material damage or contamination could occur. This symbol refers to biological hazards.

This symbol refers to electrical hazards.

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Preface

Precautions A trained specialist can be a laboratory assistant or medical technologist. WARNING • Plug the centrifuge only into sockets which have been properly grounded. • If a hazardous situation occurs, turn off the power supply to the centrifuge and leave the area immediately. Note In order to ensure safe operation of the Thermo Scientific Heraeus Megafuge 8 Centrifuge, general safety regulations must be followed: Mind the regulations in your country. It is the general obligation of the operator to make sure, that the proper protective clothing is used. Mind the „Laboratory Biosafety Manual“ of the World Health Organization (WHO) and the regulations in your country. The work environment should guarantee the following: WARNING • Maintain a radius of at least 30 cm around the centrifuge. • Implementation of special measures which ensure that no one can approach the centrifuge for longer than absolutely necessary while it is running. The power supply must be interrupted in case of an emergency. Turn off the centrifuge at the main switch. The mains plug must be freely accessible at all times. Pull out the power supply plug or disconnect the power supply in an emergency. If the centrifuge is running, press the STOP key to shut it down. In case of rotor failure the centrifuge can be damaged. Leave the room. Inform customer service. WARNING Do not open the centrifuge, while it is running. WARNING In any case of mechanical breakdown rotor failure, like burst of the rotor, breaking bottles or shaft crack, the centrifuge is not aerosol-tight.

Note Not following these instruction can cause damage.

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Preface

WARNING In order to ensure safe operation of the Thermo Scientific Heraeus Megafuge 8 Centrifuge, the following general safety regulations must be followed: • The centrifuge should be operated by trained specialists only. • The centrifuge is to be used for its intended use only. • Do not move the centrifuge while it is running. • Do not lean on the centrifuge. • Do not place anything on top of the centrifuge during a run. This applies also for the rotor landing pad. • Use only rotors and accessories for this centrifuge which have been approved by Thermo Fisher Scientific. Exceptions to this rule are commercially available glass or plastic centrifuge tubes, provided they have been approved for the speed or the RCF value of the rotor. • Contact the the customer service, if the centrifuge and the rotors are in any conspicious condition, e.g. showing signs of corrosion and/or cracks. • Do not use rotors which show any signs of corrosion and/or cracks. • Do not touch the mechanical components of the rotor and do not make any changes to the mechanical components. • Use only with rotors which have been properly installed. Follow the instructions on the Thermo Scientific Auto-Lock rotor exchange in section “Rotor Installation” on page 31. • Use only with rotors which have been loaded properly. Follow the instructions given in the rotor manual. • Never overload the rotor. Follow the instructions given in the rotor manual. • Never start the centrifuge when the door is open. • Never open the door until the rotor has come to a complete stop and this has been confirmed in the display. • The door emergency release may be used in emergencies only to recover the samples from the centrifuge, e.g. during a power failure (see section “Mechanical Emergency Door Release” on page 54). • Never use the centrifuge if parts of its cover panels are damaged or missing. • Do not touch the electronic components of the centrifuge or alter any electronic or mechanical components. • Please observe the safety instructions.

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WARNING Please pay particular attention to the following aspects: • Location: well-ventilated environment, set-up on a level and rigid surface with adequate load-bearing capacity. • Rotor installation: make sure the rotor is locked properly into place before operating the centrifuge. • Especially when working with corrosive samples (salt solutions, acids, bases), the accessory parts and vessel have to be cleaned carefully. • Always balance the samples. Centrifuging hazardous substances: • Do not centrifuge explosive or flammable materials or substances which could react violently with one another. • The centrifuge is neither inert nor protected against explosion. Never use the centrifuge in an explosion-prone environment. • Do not centrifuge inflammable substances. Remaining risk: Improper use can cause damages, contamination, and injuries with fatal consequences. • Do not centrifuge toxic or radioactive materials or any pathogenic micro-organisms without suitable safety precautions. If centrifuging any hazardous materials mind the „Laboratory Biosafety Manual“ of the World Health Organization (WHO). When centrifuging microbiological samples from the Risk Group II (according to the "Laboratory Biosafety Manual" of the World Health Organization (WHO)), aerosol-tight biological seals have to be used. Look on the internet page of the World Health Organization (www.who.int) for the „Laboratory Biosafety Manual“. For materials in a higher risk group, extra safety measures have to be taken. • If toxins or pathogenic substances have gotten into the centrifuge or its parts, appropriate disinfection measures have to be taken (see “Disinfection” on page 48). Remaining risk: Improper use can cause damages, contamination, and injuries with fatal consequences. • Highly corrosive substances which can cause material damage and impair the mechanical stability of the rotor, should only be centrifuged in corresponding protective tubes. Note If used for Foodstuffs machinery, for cosmetics or pharmaceutical products, only use closed or aerosol-tight containers for centrifugation.

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Preface

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Introduction and Description Contents

• “Characteristics” on page 16 • “Technical Data” on page 17 • “Directives, Standards and Guidelines” on page 18 • “Functions and Features” on page 19 • “Mains Supply” on page 19 • “Rotor Selection” on page 20

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1 Introduction and Description Characteristics

Characteristics The Thermo Scientific Heraeus Megafuge 8 Centrifuge is an in-vitro diagnostics device according to the In-Vitro Diagnostics Directive 98/79/EC. Several rotors with a wide range of tubes can be used. The set speed is reached within seconds. The maintenance-free induction motor ensures quiet and low-vibration operation even at high speeds, as well as guaranteeing a very long lifetime. The user-friendly control panel makes it easy to pre-set the speed, RCF value, running time, temperature, and running profile (acceleration and braking curves). You can choose between the display of speed and RCF or the entry mode. These settings can be changed even while the centrifuge is running. With the help of the PULSE key, you can also centrifuge a sample for just a few seconds. The Thermo Scientific Heraeus Megafuge 8 Centrifuge is equipped with various safety features: • The housing and the interior consist of steel plate, the rotor chamber of stainless steel, while the front panel is made of high-impact resistant plastic. • The lid is equipped with a view port and a lock. • The lid of the centrifuge can only be opened while the centrifuge is switched on and the rotor has come to a complete stop. The centrifuge cannot be started until the lid has been closed properly. • The integrated rotor detection systems ensures that no inadmissible speed settings can be preselected. • Electronic imbalance recognition • Lid emergency release: For emergencies only, e.g. during power failures (see “Mechanical Emergency Door Release” on page 54)

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1 Introduction and Description Technical Data

Technical Data The technical data of the Thermo Scientific Heraeus Megafuge 8 Centrifuge is listed in the following table. Tabelle 1-1. Technical Data Thermo Scientific Heraeus Megafuge 8 Centrifuge Feature

Value

Environmental Conditions

Designed and intended for indoor use Altitudes of up to 2,000 m above Sea Level max. relative Humidity 80 % up to 31 °C; decreasing linearly up to 50 % relative Humidity at 40 °C.

Permissible Ambient Temperature during Operation

+2 °C to +35 °C

Permissible Ambient Temperature during Storage and Shipping

-10 °C to +50 °C

Overvoltage Category

II

Pollution Degree

2

Heat Dissipation

Ventilated 0,31 kWh/h / 1060 Btu/h / 1120 kJ/h

IP

20

Max Running Time

99 h 59 min 50 sec, hold

Max Speed nmax

16000 rpm (depending on the rotor)

Min Speed nmin

300 rpm

Max RCF Value at nmax

24327xg

Maximum Kinetic Energy

8.12 < kJ

Noise Level at Maximum Speed

< 58 dB (A) TX-150 Rotor; < 61 MicroClick 24x2 Rotor

Dimensions

Ventilated

Height Height with Lid Open Width Depth Weight without Rotor

Thermo Scientific

310 mm 660 mm 370 mm 490 mm 35 kg

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1 Introduction and Description Directives, Standards and Guidelines

Directives, Standards and Guidelines Tabelle 1-2. Directives, Standards and Guidelines Tension / Frequency

Directive

Produced and inspected according to the following standards and guidelines

Europe

• 2006/95/EC Low Voltage Directive

EN 61010-1, 2nd Edition

230V 50/60Hz

• 2006/42/EC Machinery

EN 61010-2-020, 2nd Edition

• 2004/108/EC Electromagnetic compatibility (emc)

EN 61010-2-101, 2nd Edition

• 2011/65/EC RoHS Directive on the Restriction of the use of certain Hazardous Substances in electrical and electronic equipment.

EN 61326-2-6

EN 61326-1 Class B EN ISO 13485

• 2002/96/EC WEEE: Directive on Waste Electrical and Electronic Equipment • 1907/2006 REACH Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals (including requirements for SVHC, substances of very high concern) USA & Canada

FDA Device Class 1 Product code JQC (centrifuges for clinical use)

CAN/CSA-C22.2 No. 61010-1-04 UL Std. No. 61010-1, 2nd Edition)

230V 60Hz

CAN/CSA-C22.2 No. 61010-2-020-09-Part 2-020

120V 60Hz

IEC 61010-2-020, 2nd Edition IEC 61010-2-101, 2nd Edition EN ISO 13485

Japan

IEC 61010-1, 2nd Edition

100V 60Hz 100V 50Hz

IEC 61010-2-020, 2nd Edition

China

EN 61326-1 Class B

230V 50/60Hz

EN 61326-2-6

IEC 61010-2-101, 2nd Edition

EN ISO 13485

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1 Introduction and Description Functions and Features

Functions and Features The following table gives an overview of the important functional and performance characteristics of the Thermo Scientific Heraeus Megafuge 8 Centrifuge. Tabelle 1-3. Functions and Features Component / Function

Description / Features

Structure / Housing

Galvanized steel chassis with armoured plating

Chamber

Stainless steel

Drive

Induction drive without carbon brushes

Keys and display

Easy-to-clean keypad and display surface

Controls

Microprocessor-controlled

Internal memory

The most recent data is saved

Functions

RCF-selection

Acceleration / braking profiles

Standard and Soft Acceleration/Deceleration

Rotor recognition

Automatic / Electric

Imbalance recognition

Electronic, contingent on rotor and speed

Lid lock

Lid is locking, when being pressed down

Mains Supply The following table contains an overview of the electrical connection data for the Thermo Scientific Heraeus Megafuge 8 Centrifuge. This data is to be taken into consideration when selecting the mains connection socket. Tabelle 1-4. Electrical connection data of the Thermo Scientific Heraeus Megafuge 8 Centrifuge Cat.

Mains voltage ± 10 %

Frequency

Rated current

Power consumption

Equipment fuse

Building fuse

75007221

ventilated

230 V

50 / 60 Hz

2,0 A

310 W

5 AT

16 AT

75007220

ventilated

120 V

60 Hz

5,0 A

310 W

10 AT

15 AT

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1 Introduction and Description Rotor Selection

Rotor Selection The Thermo Scientific Heraeus Megafuge 8 Centrifuge is supplied without a rotor. Various rotors are available to choose from. Thermo Scientific Rotors

Part No.

TX-150 swinging bucket rotor

75005701

TX-150 round buckets

75005702

TX-150 50mL conical buckets

75005703

TX100S clinical swinging bucket rotor with sealed carriers

75005704

TX100 clinical swinging bucket rotor with carriers

75005705

M10 microplate swinging bucket rotor

75005706

M10 with buckets

75005723

MT12 microtube swinging bucket rotor

75005600

HIGHConic III fixed angle rotor

75005709

CLINIConic fixed angle rotor

75003623

MicroClick 24x2 microtube rotor

75005715

MicroClick 30x2 microtube rotor

75005719

8x8 PCR Strip rotor

75005720

Hematocrit rotor

75005733

The technical data of the rotors and the corresponding adapters and reduction sleeves for various commercially available containers can be found in the corresponding rotor operating manuals. For more information visit our website at: http://www.thermoscientific.com

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Before Use Contents

• “Before Setting up” on page 22 • “Transporting the Centrifuge” on page 23 • “Location” on page 22 • “Aligning the Centrifuge” on page 23 • “Mains Connection” on page 24 • “Storage” on page 24

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2 Before Use Before Setting up

Before Setting up 1. Check the centrifuge and the packaging for any shipping damage. Inform the shipping company and Thermo Fisher Scientific immediately if any damage is discovered. 2. Remove the packaging. 3. Check the order for completeness (see “Items Supplied” on page 9). If the order is incomplete, please contact Thermo Fisher Scientific.

Location The centrifuge should only be operated indoors. The set-up location must fulfil the following requirements: • A safety zone of at least 30 cm must be maintained around the centrifuge. People and hazardous substances must be kept out of the safety zone while centrifuging. • The supporting structure must be stable, free of resonance and plane, for example a laboratory bench. • The supporting structure must be suitable for horizontal setup of the centrifuge. • The centrifuge should not be exposed to heat. WARNING UV rays reduce the stability of plastics. Do not subject the centrifuge, rotors and plastic accessories to UV rays like in direct sunlight. • The set-up location must be well-ventilated at all times.

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