Multifuge X3 and X3R Instruction Manual June 2011

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ThermoFisher SCIENTIFIC

Ko N Fo RM trÄrs e nrlÄ nu ru c

C€

(2006 t 42 t EG; 981 37 I EG; 2006/95/EG ; 2004t 1 08 t EG ; 9s/79lEG)

DECLARATION OF CONFORMITY (2006 t 421 EC; 98 I 37 I EC; 2006/95/EC ; 2004I 1 08 I EC ; 98/79lEC)

DEcLARATIoN DE coNFoRMITE (2006 t 42 I CE: 98 I 37 I CE; 2006 I I 5 t CE; 200 4 I 1 08 I CE ; 9 8/7 9/C E )

Produkt: Product: Produit: Gerät: Model:

Labor-Zentrifuge Laboratory centrifuge Centrifugeuse de laboratoire

Heraeus Multifuge X3 Heraeus Multifuge X3R

Modöle:

Best.-Nr.: Cat.-No.:

75004500 ZSOO4S1S

R6förence: Dieses Produkt wurde in Übereinstimmung mit den Richtlinien 2006/95/EG Niederspannung, 20061 42lEG & 98/37lEG Maschinen, 2OO4l 108/EG elektromagnetische Verträglichkeit (EMV) und 98/79lEG ln-vitro-Diagnostika (lvD) hergestettt und geprüft.

This product is manufactured and duly carried out in compliance with directions 2006/95/EC Low Voltage,2006142/EC & 98137lEC Machinery, 200411081EC electromagnetic compatibility (EMC) and 98l79lEC in vitro diagnostic medical devices. Ce produit est fabriquö et testö selon les directives 2006/95/CE mat6riel ölectrique destin6 ä ötre employö dans certaines limites de tension, 2006142lCE & 98/37lCE machines, 20041108/CE la compatibilit6 6lectromagnötique, 98179lCE dispositifs mödicaux de diagnostic in vitro.

Normen / Standards / Normes: EN 61010-1:2004 / EN 6101Q-2-Q20.2006 I EN 61010-2-1Q1:2002 EN 61326-1: 2006 / EN 61326-2-6: 2006 I EN 5501 18. 2007 / EN 61000-6-2: 2Q05 EN ISO 13485: 2003 Osterode, den 1 2.03.2009

Thermo Electron LED GmbH Werk Osterode Am Kalkberg D-37520 Osterode

a CI.q

Dr. Thomas näk Werkleiter Erstelll Freioeoeben

lienemänn aus Vollherdt

atum 12 03 90,n9 12 03 2N9

)okument /5004500-1 501 19468.doc '/lHSDOCKONF

Revision

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 following symbol:

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 Intended Use ...iii Accident Prevention ... iv Precautions ... iv

Thermo Scientific

Chapter 1

Introduction and Description ...1-1 Characteristics of the Heraeus Multifuge X3 / X3R ...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 Control Panel ...3-2 Keys ...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 Centrifugation ...4-10 Temperature Adaptation during Standstill ...4-11 Short-term Centrifugation ...4-11 Removing the Rotor ...4-11 Aerosol-tight Rotors ...4-12 Aligning the Centrifuge ...4-12

Heraeus Multifuge X3

i

Contents

Chapter 5

System Menu ... 5-1 Description ... 5-2

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 ... 6-5

Chapter 7

Trouble Shooting ... 7-1 Mechanical Emergency Door Release ... 7-2 Troubleshooting by User ... 7-3 When to contact Customer Service ... 7-5

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

ii

Heraeus Multifuge X3

Thermo Scientific

P

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 Multifuge X3

1

Power supply cable

1

50117498

Instruction manual

1

70009824

Anti-corrosion oil

1

Check

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

Intended 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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Multifuge X3 / X3 R

iii

P Accident Prevention

Accident Prevention Prerequisite for the safe operation of the Heraeus Multifuge X3 / X3R 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 Multifuge X3 / X3R, 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. • Plug the centrifuge only into sockets which have been properly grounded. • Do not move the centrifuge while it is running. • Do not lean on the centrifuge. • 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 4-2. • 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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Multifuge X3 / X3 R

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P Precautions

• 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 Door 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. 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. • Do not centrifuge toxic or radioactive materials or any pathogenic micro-organisms without suitable safety precautions. When centrifuging microbiological samples from the Risk Group II (according to the 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 6-3). • 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.

Intended 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

Thermo Scientific

Multifuge X3 / X3 R

v

P Precautions

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. Observe the information contained in the instruction manual to keep yourself and your environment safe.

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Multifuge X3 / X3 R

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1

Introduction and Description Contents

• “Characteristics of the Heraeus Multifuge X3 / X3R” on page 1-2 • “Technical Data” on page 1-3 • “Directives, Standards and Guidelines” on page 1-4 • “Functions and Features” on page 1-5 • “Mains Supply” on page 1-5 • “Rotor Selection” on page 1-6

Thermo Scientific

Multifuge X3 / X3 R

1-1

1 Introduction and Description Characteristics of the Heraeus Multifuge X3 / X3R

Characteristics of the Heraeus Multifuge X3 / X3R The Heraeus Multifuge X3 / X3R 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, 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 for.

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

The Heraeus Multifuge X3 / X3R 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 “Mechanische Notentriegelung des Deckels” auf Seite 7-2)

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Multifuge X3 / X3 R

Thermo Scientific

1 Introduction and Description Technical Data

Technical Data The technical data of the Heraeus Multifuge X3 / X3R is listed in the following table. Table 1-1. Technical Data Heraeus Multifuge X3 / X3R 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

+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

max Speed nmax

15200 rpm (depending on the rotor)

15200 rpm (depending on the rotor)

min Speed nmin

300 rpm

300 rpm

maximum RCF value at nmax

25314 x g

25314 x g

maximum kinetic energy

< 62.5 kJ

< 62.5 kJ

noise level at maximum speed

< 64 dB (A)

< 64 dB (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

Multifuge X3 / X3 R

1-3

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

UL 61010-1, 2nd Edition

120V 60Hz

CAN/CSA-C22.2 No. 61010-1, 2nd Edition

100V 60Hz

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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Multifuge X3 / X3 R

Thermo Scientific

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 Multifuge X3 / X3R. 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 Multifuge X3 / X3R. This data is to be taken into consideration when selecting the mains connection socket. Table 1-4. Electrical connection data of the Heraeus Multifuge X3 / X3R Cat.

Thermo Scientific

Mains voltage

Frequency

Rated current

Power consumption

Equipment fuse

Building fuse

7500 4515

refrigerated

230 V

50 / 60 Hz

10,5 A

1950 W

15 AT

16 AT

7500 4516

refrigerated

120 V

60 Hz

12 A

1400 W

15 AT

15 AT

7500 4500

ventilated

230 V

50 / 60 Hz

11 A

1700 W

15 AT

16 AT

7500 4501

ventilated

120 V

60 Hz

12 A

1400 W

15 AT

15 AT

Multifuge X3 / X3 R

1-5

1 Introduction and Description Rotor Selection

Rotor Selection The Heraeus Multifuge X3 / X3R 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

TM

BIOshield

1000A

TM

BIOLiner

HIGHPlate

7500 3603 7500 3667

TM

6000

7500 3606

FIBERLite

TM

H3LV

7500 3665

FIBERLite

TM

F14S-6 x 250 LE

7500 3662

FIBERLite

TM

F15-6 x 100

7500 3698

FIBERLite

TM

F13S-14 x 50c

7500 3661

FIBERLite

TM

F15-8 x 50c

7500 3663

FIBERLite

TM

F21-48 x 2

7500 3664

Microliter 48 x 2 TM

HIGHConic M-20

6 x 100

7500 3602 7500 3620 7500 3624

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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Multifuge X3 / X3 R

Thermo Scientific

2

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

Thermo Scientific

Multifuge X3 / X3 R

2-1

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 centrifuging. • 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.

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Multifuge X3 / X3 R

Thermo Scientific

2 Before use Aligning 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 horizontal 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 Connection 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. 4. Make sure that the voltage and frequency correspond to the figures on the rating plate. 5. Establish the connection to the power supply with the connecting cable.

Thermo Scientific

Multifuge X3 / X3 R

2-3

2 Before use Storage

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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Multifuge X3 / X3 R

Thermo Scientific