Medifuge Small Benchtop Centrifuge Instructions for Use Rev G March 2020 PDF download

Thermo Scientific Medifuge Small Benchtop Centrifuge Instructions for Use 50148677-g • 03 / 2020

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Thermo Scientific Medifuge Centrifuge

Table of Contents Preface ��5 Intended Use�� 5 Items Supplied �� 6 Precautions�� 7 Signal Words and Colors�� 7 Set Up Conditions�� 7 Shutdown �� 7 Preparation �� 8 Hazardous Substances�� 8 Operation�� 9 Maintenance�� 9 Service Lifetime�� 10

Symbols used on the Centrifuge �� 11 Symbols used in the Manual�� 11

I. Technical Specifications��12 1. Technical Data�� 12 Thermo Scientific Medifuge Centrifuge�� 12 Thermo Scientific DualSpin Rotor�� 13

2. Rotor and Accessories�� 14 3. Directives, Standards and Guidelines�� 15 4. Mains Supply�� 16

II. Transport and Set Up��17 1. Before Setting Up�� 17 2. Location �� 17 3. Transporting�� 18 4. Leveling �� 18 5. Mains Connection �� 19 2

Thermo Scientific Medifuge Centrifuge

6. Storage�� 19 7. Shipping�� 20

III. Control Panel�� 21 Control Panel Settings �� 22 Select RPM/RCF�� 22 Select Runtime�� 24 Acceleration / Deceleration Profiles�� 25 Programs�� 26 Acoustic Signals�� 27

IV. Operation�� 28 1. Switching on the Centrifuge�� 28 2. Open the Centrifuge Door �� 28 3. Rotor Installation�� 29 Installation of Swing Out Buckets �� 31

4. Rotor Temperature Range�� 32 5. Rotor Loading�� 32 Maximum Loading�� 34 Tube and Spacer Guide �� 35 Swing Out Bucket �� 39 Checking the Rotor Lifetime�� 41

6. Close the Centrifuge Door�� 42 7. Centrifugation�� 43 Before a Run�� 43 Starting the Centrifugation �� 43 Stopping the Centrifugation �� 44

8. Removing the Rotor�� 45 9. Switch off the Centrifuge�� 45

V. Maintenance and Care�� 46 1. Cleaning Intervals �� 46 3

Thermo Scientific Medifuge Centrifuge

2. Basics�� 47 3. Cleaning�� 48 4. Disinfection �� 49 5. Decontamination �� 50 6. Service of Thermo Fisher Scientific�� 51 7. Shipping and Disposal�� 51

VI. Troubleshooting�� 52 1. Mechanical Emergency Door Release�� 52 2. Troubleshooting by Guide �� 53 3. When to contact Customer Service�� 54

Chemical Compatibility Chart�� 55 Declaration of Decontamination�� 67 Acceleration/Deceleration Profiles�� 70 Index�� 71

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Thermo Scientific Medifuge Centrifuge

Preface Before using the centrifuge, read through this instruction manual carefully and follow the instructions. Not following the instructions and safety information in this instruction manual will result in the expiration of the sellers warranty.

Intended Use This centrifuge is intended to be used as a laboratory equipment to separate sample mixtures of different densities. This centrifuge can be used as an In-Vitro diagnostics device (Directive 98/79/EC), if used together with IVD tubes, to separate blood into its components such as serum and plasma for further clinical diagnostic analysis. The centrifuge has to be operated by a trained individual such as a clinical laboratory technologist or a trained laboratory technician.

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Thermo Scientific Medifuge Centrifuge

Items Supplied The Thermo Scientific™ Medifuge™ small benchtop centrifuge is supplied with a rotor and 2 bucket sets. Size and relation of graphics are not showing real dimensions and are just for visual identification. If any parts are missing, please contact the nearest Thermo Fisher Scientific representative. Article No.

Item

Graphic

Quantity

Centrifuge Thermo Scientific Medifuge small benchtop centrifuge

1

Power supply cable

1

Rotor 75008810

Thermo Scientific™ DualSpin™ rotor (factory installed) with fixed angle and swinging buckets sets, including:

1

Fixed angle buckets

8

Swing out buckets

8

50148478

Rotor locking nut (factory installed)

1

75008817

Spacers (short & green)

8

75008818

Spacers (long & yellow)

8

50149182

Hex key (tool for emergency lid lock)

1

Instruction manual

1

CD

1

6

Thermo Scientific Medifuge Centrifuge

Precautions Signal Words and Colors WARNIN G

Indicates a hazardous situation that, if not avoided, could result in death or

CAUTION

Indicates a hazardous situation that, if not avoided, could result in minor or

NOTICE

Indicates information considered important, but not hazard-related (e.g.

serious injury.

moderate injury (e.g. sample loss).

messages relating to property damage).

NOTICE Observe the safety instructions. Not following these instructions can cause damage. The centrifuge is to be used for its intended use only. Improper use can cause damages, contamination, and injuries with fatal consequences.

Set Up Conditions

Set up in a well-ventilated environment, on a horizontally levelled and rigid surface with adequate load-bearing capacity.

As safety zone maintain a clear radius of at least 30 cm around the centrifuge. Do not place any dangerous substances within this security zone.

Plug the centrifuge only into sockets which have been properly grounded.

The mains plug must be freely accessible at any time.

CAUTION Not following the set up conditions can result in minor or serious injuries.

Shutdown Turn off the centrifuge at the main switch. The mains plug must be freely accessible at any time. Press the STOP key to shut down the centrifuge. Pull out the power supply plug or disconnect the power supply in an emergency. 7

Thermo Scientific Medifuge Centrifuge

Preparation

Use only with a rotor that has been properly installed. Follow the instructions in section “Rotor Installation” on page 29.

Do not use a rotor or accessories that show any signs of corrosion or cracks. Contact customer service for further advice or inspections.

Use only with a rotor that has been properly loaded.

Never overload the rotor.

Always balance the samples.

Use only rotors and accessories for this centrifuge that have been approved by Thermo Fisher Scientific.

Make sure the rotor is locked properly into place before operating the centrifuge.

WARNING It is the obligation of the operator to make sure, that protective clothing is used. Mind the “Laboratory Biosafety Manual” of the World Health Organization (WHO) and the regulations in your country. CAUTION

Implement measures which ensure that no one can approach the centrifuge for longer than absolutely necessary while it is running.

Do not use a damaged rotor. Replace the rotor, if it was dropped.

Hazardous Substances WARNING

Especially when working with corrosive samples (salt solutions, acids, bases), the accessory parts and vessel have to be cleaned thoroughly.

Do not centrifuge explosive or flammable materials or substances.

The centrifuge is not inert or protected against explosion. Never use the centrifuge in an explosion-prone environment.

Do not centrifuge toxic or radioactive materials or any pathogenic micro-organisms without suitable safety precautions.

If any hazardous materials are centrifuged, mind the “Laboratory Biosafety Manual” of the World Health Organization (WHO) and any local regulations. 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. 8

Thermo Scientific Medifuge Centrifuge

If toxins or pathogenic substances have contaminated the centrifuge or its parts, appropriate disinfection measures have to be taken (“Disinfection” on page 49).

Extreme care should be taken with highly corrosive substances which can cause damage and impair the mechanical stability of the rotor. These should only be centrifuged in fully sealed tubes.

If a hazardous situation occurs, turn off the power supply to the centrifuge and leave the area immediately.

Operation WARNING

Never use the centrifuge if parts of its cover panels are damaged or missing.

Do not move the centrifuge while it is running.

Do not place anything on top of the centrifuge during a run.

CAUTION

Do not lean on the centrifuge.

Never open the centrifuge door until the rotor has come to a complete stop and this has been confirmed in the display.

The emergency door release may be used in emergencies only to recover the samples from the centrifuge, e.g. during a power failure (“Mechanical Emergency Door Release” on page 52).

NOTICE In any case of severe mechanical failure, such as a rotor crash, the centrifuge is not aerosol-tight. In case of rotor failure the centrifuge can be damaged. Leave the room. Inform customer service.

Maintenance WARNING

The centrifuge housing is not to be opened by the operator.

Do not change or replace mechanical or electrical components. Changing or replacing components can result in death or serious injury.

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Thermo Scientific Medifuge Centrifuge

Service Lifetime The centrifuge is designed for 10 years or 140000 cycles of service, whichever is first. Usage beyond these limits might affect the safety of the centrifuge housing or the lid latch system. The rotor is designed for 5 years or 60000 cycles of service, whichever is first. Usage beyond these limits might lead to rotor failure, sample loss and damage to the centrifuge.

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Thermo Scientific Medifuge Centrifuge

Symbols used on the Centrifuge This symbol refers to general hazards.

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 physical hazards from hot surfaces.

This symbol refers to information on hazards, described within the manual.

This symbol demands to disconnect mains before transporting or servicing the centrifuge. This symbol demands to make sure that a swing out bucket is installed correctly with its fin.

Symbols used in the Manual This symbol refers to general hazards.

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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Thermo Scientific Medifuge Centrifuge

I. Technical Specifications 1. Technical Data Thermo Scientific Medifuge Centrifuge Environmental Conditions

For interior use Altitudes of up to 3000 m above sea level Max. relative humidity 80 % up to 31 °C; decreasing linearly to 50 % relative humidity at 40 °C

Environmental Conditions during Storage and Shipping

Temperature: -10 °C to +55 °C

Permissible Ambient Temperature during Operation

+2 °C to +40 °C

Heat Dissipation

0.123 kWh; 419.7 Btu/h; 442.8 kJ/h

Overvoltage Category

II

Pollution Degree

2

IP

20

Running Time

99 min; hold

Maximum Speed nmax

4900 rpm

Minimum Speed nmin

300 rpm

Humidity: 15 % to 85 %

Maximum RCF Value at nmax Fixed Angle Setup

3114 x g

Swing Out Setup

3490 x g

Noise Level at Maximum Speed

< 56 dB (A)

Maximum Kinetic Energy

680 J

1

Dimensions

1 2

Height (open door / closed door)

510 mm / 240 mm

Width

325 mm

Depth

450 mm

Weight2

15.5 kg

Front Side Measurement, 1 m in front of the instrument at 1.6 m height. Without Rotor.

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Thermo Scientific Medifuge Centrifuge

Thermo Scientific DualSpin Rotor Maximum Permissible Load

8 x 30 g

Maximum Allowed Imbalance

10 g

Maximum Speed nmax

4900 rpm

Maximum RCF-Value at nmax Fixed Angle Setup

3114 x g

Swing Out Setup

3490 x g

Max. Cycle Number

60000

Radius max. / min. Fixed Angle Setup

116 mm / 37 mm

Swing Out Setup

130 mm / 42 mm

Angle Fixed Angle Setup

45°

Swing Out Setup

12 - 87°

Acceleration / Braking Time* Fixed Angle Setup

24 s / 37 s

Swing Out Setup

24 s / 31 s

Autoclavable *

No

Deceleration time at standard curve.

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Thermo Scientific Medifuge Centrifuge

2. Rotor and Accessories Article No.

Description

75008810

Thermo Scientific DualSpin rotor (1x) with fixed angle buckets (8x) and swinging buckets (8x)

Graphic

75008813

Thermo Scientific DualSpin rotor body (1x)

75008815

Fixed angle buckets (8x)

75008816

Swing out buckets (8x)

50148478

Rotor locking nut

75008817

Spacers (green, 8x)

75008818

Spacers (yellow, 8x)

50149182

Hex key (tool for emergency lid lock)

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Thermo Scientific Medifuge Centrifuge

3. Directives, Standards and Guidelines Region

Directive

Standard

Europe

98/79/EC in vitro diagnostic medical devices (IVD)

EN 61010-1, 3rd Edition

220–230 V, 50 / 60 Hz

IEC 61010-2-020, 3rd Edition

2014/35/EC Low Voltage (protective goals)

IEC 61010-2-101, 3rd Edition

2006/42/EC Machinery (protective goals)

EN 61326-2-6

2014/30/EC Electromagnetic Compatibility (EMC) (protective goals) 2011/65/EC RoHS – Directive on the Restriction of the use of certain Hazardous Substances in electrical and electronic equipment

EN 61326-1 Class B

EN 62304 EN 62366 EN ISO 14971 EN ISO 13485

North America (USA & Canada)

FDA

EN 61010-1, 3rd Edition

Product Code JQC

IEC 61010-2-020, 3rd Edition

230 V, 60 Hz

Device Class 1

IEC 61010-2-101, 3rd Edition

120 V, 60 Hz

Centrifuges for Clinical Use

EN 61326-1 Class B EN 61326-2-6 EN 62304 EN 62366 EN ISO 14971 EN ISO 13485

Japan

EN 61010-1, 3rd Edition

100 V, 50/60 Hz

IEC 61010-2-020, 3rd Edition

China

IEC 61010-2-101, 3rd Edition

220 V, 50 Hz

EN 61326-1 Class B EN 61326-2-6 EN 62304 EN 62366 EN ISO 14971 EN ISO 13485

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Thermo Scientific Medifuge Centrifuge

4. Mains Supply The following table contains an overview of the electrical connection data. This data is to be taken into consideration, when selecting the mains connection socket. Unit

Thermo Scientific Medifuge small benchtop centrifuge

Article No.

75008802

75008801

75008800

Mains Voltage

100 V ±10%

120 V ±10%

220-230 V ±10%

Frequency

50 / 60 Hz

60 Hz

50 / 60 Hz

Rated Current

1.7 A

1.8 A

1.1 A

Power Consumption

100 W

130 W

Equipment Fuse

6.3 AT

4 AT

2 AT

Building Fuse

16 AT

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Thermo Scientific Medifuge Centrifuge

II. Transport and Set Up 1. 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. NOTICE Dispose of the packaging. Do not reuse it.

3.

Check, if the items supplied are complete (“Items Supplied” on page 6). The rotor is factory installed and tightened with the rotor locking nut inside the centrifuge. You can only check the rotor and the rotor locking nut by opening the centrifuge door when the centrifuge is connected to the power supply (“Mains Supply” on page 16) and switched on (“Open the Centrifuge Door” on page 28). If the items supplied are incomplete, please contact Thermo Fisher Scientific.

2. Location CAUTION

UV rays reduce the stability of plastics. Do not subject the centrifuge, rotor and plastic accessories to direct sunlight.

The centrifuge is only to be operated indoors. The set-up location must fulfill 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 this safety zone while centrifuging.

The supporting structure must be stable and free of resonance.

The supporting structure must be suitable for horizontal setup of the centrifuge.

The centrifuge is not to be exposed to heat and strong sunlight.

The set-up location must be well-ventilated at all times.

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Thermo Scientific Medifuge Centrifuge

3. Transporting WARNIN G

The centrifuge can be damaged by impact. Do not operate the centrifuge if an impact occurred.

CAUTION

Do not use a damaged rotor. Replace the rotor, if it was dropped. Using a damaged rotor can cause a crash.

NOTICE

Always remove buckets before transporting the centrifuge. Buckets can fall into the rotor chamber. Always make sure that the buckets are in correct position before operation.

Transport the centrifuge upright and with the centrifuge door closed.

4. Leveling The centrifuge is to be placed on horizontal and level supporting structures or benching. If necessary level the supporting structures or benching to level the centrifuge. Horizontal level has to be checked after moving the centrifuge to a new location.

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Thermo Scientific Medifuge Centrifuge

5. Mains Connection C AUTIO N

Plug the centrifuge into grounded electrical sockets only.

1.

Turn off the power supply switch located on the back side.

2.

Check whether the cable complies with the safety standards of your country.

3.

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

4.

Establish the connection to the power supply with the connecting cable.

6. Storage WAR NING

When removing the centrifuge and accessories from use, clean and additionally disinfect or decontaminate the entire system if biological or chemical substances were used. If in doubt contact the Thermo Fisher Scientific customer service.

Before storing the centrifuge and the accessories it must be cleaned and if necessary disinfected and decontaminated. Centrifuge, rotor, buckets and accessories have to be thoroughly dried before storage.

Store the centrifuge in a clean, dust-free location.

Be sure to place the centrifuge on its feet.

Avoid storing the centrifuge in direct sunlight.

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Thermo Scientific Medifuge Centrifuge

7. Shipping WAR NING

Before shipping the centrifuge and accessories you have to clean and additionally disinfect or decontaminate the entire system if biological or chemical substances were used. In doubt contact the Thermo Fisher Scientific customer service.

Before shipping the centrifuge please keep the following in mind:

The centrifuge must be cleaned and decontaminated.

The decontamination must be confirmed with a decontamination certificate (“Declaration of Decontamination” on page 67).

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