Megafuge 40 and 40R Instruction Manual Rev 0 July 2009

© 2009 Thermo Fisher Scientific Inc. All rights reserved. BIOLinerTM, BIOShieldTM, HIGHPlateTM, HIGHConicTM, AutoLockTM, FIBERLite TM and CLINIConicTM re either registered trademarks or trademarks of Thermo Fisher Scientific.

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. 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. 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.

Release history: 50119920-4 printed in July 2009.

For Research Use Only. Not for use in diagnostic procedures.

WEEE Conformity This product is subject to the regulations of the EU Waste Electrical & Electronic Equipment (WEEE) Directive 2002/96 It is marked by the symbol opposite:

Thermo Fisher Scientific has entered into agreements with recycling and disposal companies in all EU Member States for the recycling and disposal of this device. For information on recycling and disposal companies in Germany and on the products of Thermo Fisher Scientific, which fall under the RoHS Directive (Restriction of the use of certain hazardous substances in electrical and electronic equipment), please visit the website www.thermo.com/WEEERoHS.

T Table of Contents Preface ...iii Scope of Supply ...iii Proper Use ...iii Accident Prevention ... iv Precautions ... iv

Thermo Scientific

Chapter 1

Introduction and Description ...1-1 Characteristics ...1-2 Technical Data ...1-3 Directives, Standards and Guidelines ...1-4 Functions and Features ...1-5 Mains Supply ...1-5 Rotor Selection ...1-6

Chapter 2

Before use ...2-1 Before Setting up ...2-2 Transporting the Centrifuge ...2-2 Location ...2-2 Aligning the Centrifuge ...2-3 Mains Connection ...2-3 Storage ...2-4

Chapter 3

Control Panel ...3-1 Keys ...3-2 Control Panel ...3-2

Chapter 4

Operation ...4-1 Switch on Centrifuge ...4-2 Lid Opening ...4-2 Close Lid ...4-2 Rotor Installation ...4-2 Entering Parameters ...4-4 Saving Programs ...4-6 Centrifugation ...4-7 Temperature Adaptation during Standstill ...4-8 Short-term Centrifugation ...4-8 Removing the Rotor ...4-8 Aerosol-tight Rotors ...4-9 Switching the Centrifuge off ...4-9

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Table of Contents

Chapter 5

System Menu ... 5-1

Chapter 6

Maintenance and Care ... 6-1 Cleaning Intervalls ... 6-2 Cleaning ... 6-2 Disinfection ... 6-3 Decontamination ... 6-4 Autoclaving ... 6-5 Service of Thermo Fisher Scientific ... 6-6

Chapter 7

Troubleshooting ... 7-1 Mechanical Emergency Lid Release ... 7-2 Troubleshooting by User ... 7-3 When to contact Customer Service ... 7-6

Chemical Compatibility Chart ...A-1 Contact Information ...B-1

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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.

Scope of Supply Article Number

Quantity Centrifuge Heraeus Megafuge 40

1

Power supply cable

1

50119920

Instruction manual

1

70009824

Anti-corrosion oil

1

Check

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

Proper Use • This centrifuge is an IVD accessory, and therefore subject to the Directive 98/79/EC of the European Parliament and the Council of October 27, 1998 on in vitro diagnostic medical devices. • This centrifuge is a laboratory product designed to separate components by generation of Relative Centrifugal Force. It separates human samples (e.g. blood, urine and other body fluids) collected in appropriate containers, either alone or after addition of reagents or other additives. • As general-purpose centrifuge, it is designed to also run other containers filled with chemicals, environmental samples and other non-human body samples. • This centrifuge should be operated by trained specialists only.

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P Accident Prevention

Accident Prevention Prerequisite for the safe operation of the Heraeus Megafuge 40 / 40R is a work environment in compliance with standards, directives and trade association safety regulations and proper instruction of the user: The safety regulations contain the following basic recommendations: • 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 mains plug must be freely accessible at all times. Pull out the power supply plug or disconnect the power supply in an emergency.

Precautions In order to ensure safe operation of the Heraeus Megafuge 40 / 40R, the following general safety regulations must be followed: • Do not manipulate the safety devices. • The centrifuge should be operated by trained specialists only. • The centrifuge is to be used for its intended purpose only. • Plug the centrifuge only into sockets which have been properly grounded. • Do not move the centrifuge while it is running. • 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. • 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 Autolock in section “Rotor installation” on page 4-5. • 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 lid is open. • Never open the lid until the rotor has come to a complete stop and this has been confirmed in the display.

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• The lid 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 lid release” on page 7-2). • 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. 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. centrifugation 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. • Do not centrifuge toxic or radioactive materials or any pathogenic micro-organisms without suitable safety precautions. When centrifugation microbiological samples from the Risk Group II (according to the "Laboratory Bio-safety Manual" of the World Health Organization WHO), aerosol-tight biological seals have to be used. 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 6-4). • Highly corrosive substances which can cause material damage and impair the mechanical stability of the rotor, should only be centrifuged in corresponding protective tubes. IF A HAZARDOUS SITUATION OCCURS, TURN OFF THE POWER SUPPLY TO THE CENTRIFUGE AND LEAVE THE AREA IMMEDIATELY.

Normal use The centrifuge is to be used for separating materials of different density or particle size suspended in a liquid. g

Maximum sample density at maximum speed: 1,2 ---------3 cm

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P Precautions

The symbol on the left refers to general hazards. ATTENTION means that material damage could occur. WARNING means that injuries or material damage or contamination could occur. The symbol on the left refers to biological hazards. Observe the information contained in the instruction manual to keep yourself and your environment safe.

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Introduction and Description Contents

• “Characteristics” on page 1-2 • “Technical Data” on page 1-3 • “Functions and Features” on page 1-5 • “Rotor Selection” on page 1-6

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1 Introduction and Description Characteristics

Characteristics The Heraeus Megafuge 40 / 40R is an in-vitro diagnostics device according to the In-Vitro Diagnostics Directive 98/79/EC. Several rotors with commercial tubes can be used. The set speed is reached in seconds. The maintenance-free induction motor ensures quiet and low-vibration operation even at high speeds, and guarantees 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 called for.

, you can also centrifuge a sample for just a few seconds, if

The Heraeus Megafuge 40 / 40R is equipped with various safety features: • The housing and rotor chamber consist of steel plate, the interior of armour 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 lid release” on page 7-2

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1 Introduction and Description Technical Data

Technical Data The technical data of the Heraeus Megafuge 40 / 40R is listed in the following table. Table 1-1. Technical Data Heraeus Megafuge 40 / 40R Feature

Value

Environmental conditions

- use in interior spaces - 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

+2° C to +35° C

Overvoltage category

II

II

Pollution degree

2

2

Heat dissipation

ventilated

refrigerated

230V

120V

230V

120V

5800 BTU/h

4776 BTU/h

6653 BTU/h

4776 BTU/h

IP

20

20

running time

unlimited

unlimited

maximum speed nmax

15200 rpm (depending on the rotor)

15200 rpm (depending on the rotor)

minimum speed nmax

300 rpm

300 rpm

maximum RCF value at nmax

25314 xg

25314 xg

maximum kinetic energy

< 62,5 kJ

< 62,5 kJ

noise level at maximum speed

< 64dB (A)

< 64dB (A)

temperature setting range Dimensions Height Width Depth Table top height weight without rotor

Thermo Scientific

-10 °C to +40 °C ventilated

refrigerated

360 mm 550 mm 670 mm 310 mm

360 mm 745 mm 670 mm 310 mm

86 kg

116 kg

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1 Introduction and Description Directives, Standards and Guidelines

Directives, Standards and Guidelines Table 1-2. Directives, standards and guidelines Tension / Frequency 230V 50/60Hz

Produced and inspected according to the following standards and guidelines 2006/95/EC Low Voltage Directive:

EN 61010-1, 2nd Edition

2006/42/EC & 98/37/EC Machine Directive:

EN 61010-2-020, 2nd Edition

2004/108/EC EMC Directive

EN 61010-2-101

98/79/EC In-vitro-Diagnostika (IvD)

EN 61326-1 EN 61326-2-6 EN 55011B EN 61000-6-2 EN ISO 13485

230V 60Hz 120V 60Hz 100V 60Hz

The centrifuges are produced and inspected according to the following standards and guidelines

UL 61010-1, 2nd Edition CAN/CSA-C22.2 No. 61010-1, 2nd Edition IEC 61010-2-20, 2nd Edition (Pollution degree 2, Overvoltage category II) IEC 61010-2-101 Emitted interference FCC Part 15 CLASS A NOTE: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense.

100V 50Hz

IEC 61010-1 2nd Edition IEC 61010-2-020 2nd Edition IEC 61010-2-101 EN 61326-1 EN 61326-2-6 EN 55011A EN 61000-6-2 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 Heraeus Megafuge 40 / 40R. Table 1-3. Functions and features Component / Function

Description / Features

Structure / Housing

Galvanized steel chassis with armoured plating.

Chamber

Stainless steel / varnished 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, temperature control, pretemp with cooling equipped devices

Acceleration / braking profiles

9 acceleration and 10 braking curves

Rotor recognition

Automatic

Imbalance recognition

Electronic, contingent on rotor and speed

Lid lock

Automatic lid closing and locking starting from an initial hold position

Mains Supply The following table contains an overview of the electrical connection data for the Heraeus Megafuge 40 / 40R. This data is to be taken into consideration when selecting the mains connection socket. Table 1-4. Electrical connection data of the Heraeus Megafuge 40 / 40R Cat. No.

Mains voltage

Frequency

Rated current

Power consumption

Equipment fuse

Building fuse

7500 4518

refrigerated

230 V

50 / 60 Hz

10,5 A

1950 W

15 AT

16 AT

7500 4519

refrigerated

120 V

60 Hz

12 A

1400 W

15 AT

15 AT

7500 4503

ventilated

230 V

50 / 60 Hz

11 A

1700 W

15 AT

16 AT

7500 4504

ventilated

120 V

60 Hz

12 A

1400 W

15 AT

15 AT

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1 Introduction and Description Rotor Selection

Rotor Selection The Heraeus Megafuge 40 / 40R is supplied without a rotor. Various rotors are available to choose from. TX-750

7500 3607 with round buckets

7500 3608

with rectangular buckets

7500 3614

incl. Microtiter carrier

7500 3617

incl. ABI-bucket

7500 3618

BIOShieldTM 1000A

7500 3603

TM

7500 3667

BIOLiner

FIBERLiteTM F15-6 x 100 CFK FIBERLite

TM

F21-48 x 2

Microliter 48 x 2 TM

HIGHConic

6 x 100

7500 3698 7500 3664 7500 3602 7500 3620

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.thermo.com

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Before use Contents

• “Before Setting up” on page 2-2 • “Transporting the Centrifuge” on page 2-2 • “Location” on page 2-2 • “Aligning the Centrifuge” on page 2-3 • “Mains Connection” on page 2-3 • “Storage” on page 2-4

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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 “Scope of Supply” on page iii.). If the order is incomplete, please contact Thermo Fisher Scientific.

Transporting the Centrifuge • Due to its weight (see “Technical Data” on page 1-3), the centrifuge should be carried by several people. • Always lift the centrifuge at both sides.

Figure 2-1. Lifting the centrifuge at both sides. • The centrifuge can be damaged by impacts. • Transport the centrifuge upright and if at all possible in its packaging. WARNING Always lift the centrifuge on both sides. Never lift the centrifuge by its front or the back panel. Always remove the rotor before moving the centrifuge.

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 centrifugation.

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2 Before use Aligning the Centrifuge

• The supporting structure must be stable and free of resonance, for example a level laboratory bench. • The supporting structure must be suitable for horizontal setup of the centrifuge. • The centrifuge should not be exposed to heat and strong sunlight. WARNING UV rays reduce the stability of plastics. Do not subject the centrifuge, rotors and plastic accessories to direct sunlight. • The set-up location must be well-ventilated at all times.

Aligning the Centrifuge The alignment of the centrifuge must be checked every time after moving it to a different location. The supporting structure must be suitable for horizontal setup of the centrifuge. CAUTION If the centrifuge isn’t level, imbalances can occur and the centrifuge can be damaged. Do not place anything under the feet to level the centrifuge.

Mains Connection

Main Power Switch Mains plug

Figure 2-2. Mains connections 1. Turn off the power supply switch on the back (press "0"). 2. Plug the centrifuge into grounded electrical sockets only. 3. Check whether the cable complies with the safety standards of your country.

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2 Before use Storage

4. Make sure that the voltage and frequency correspond to the figures on the rating plate.

Figure 2-3. Rating plate of the Heraeus Megafuge 40 5. Establish the connection to the power supply with the connecting cable.

Storage • Before storing the centrifuge and the accesories it must be cleanedand if necessary desinfected and decontaminated. • Store the centrifuge in a clean, dust-free location. • Be sure to place the centrifuge on its feet. • Avoid direct sunlight.

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Control Panel Contents

• “Keys” on page 3-2 • “Control Panel” on page 3-2

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