THARMAC Cellspin II Manuel utilisateur

Instruction manual

Cellspin® II / Cellspin® IIR

Cytocentrifuge

Man CS2/CS2R 01.2017 EN

THARMAC® GmbH - Cellspin® II/IIR - Instruction

manual

Contact:

THARMAC® GmbH

Hasselborner Straße 19-21

35647 Waldsolms

Germany

Fon:

+49-(0)6085 - 98 99 10

Fax:

+49-(0)6085 - 98 99 119

Mail: [email protected]

www.tharmac.de

THARMAC® GmbH

Borsigstraße 7A

65205 Wiesbaden

Germany

Fon:

+49-(0)6122 - 588 97 33

Fax:

+49-(0)6122 - 588 97 36

Mail: [email protected]

www.tharmac.de

Cellspin®, Cellfunnel® and TPX-Funnel®, ECOfunnel® and GynoPrep® are registered trademarks.

THARMAC® GmbH - Cellspin® II/IIR - Instruction

manual

Table of contents

1Use according to specification ......................................................................................................... 5

2Remaining risks..................................................................................................................................... 5

3Technical specifications ..................................................................................................................... 5

4Notes on safety.................................................................................................................................... 7

5Symbol meanings ................................................................................................................................ 9

6Delivery checklist................................................................................................................................. 9

7Unpacking the centrifuge.................................................................................................................. 9

8Initial operation.................................................................................................................................. 10

9Opening and closing the lid ............................................................................................................ 10

Opening the lid ........................................................................................................................................... 10

Closing the lid .............................................................................................................................................. 10

10 Installation and removal of the rotor .............................................................................................. 11

11 Loading the rotor............................................................................................................................... 11

12 Control and display elements ......................................................................................................... 11

Control knob................................................................................................................................................ 11

Control panel pushbuttons (keys) ............................................................................................................ 11

Adjustment possibilities............................................................................................................................... 12

13 Entering centrifugation parameter ................................................................................................ 12

14 Programming ..................................................................................................................................... 13

Program input/alteration ........................................................................................................................... 13

Program recall............................................................................................................................................. 13

15 Centrifugation ................................................................................................................................... 13

Centrifugation with pre-set time............................................................................................................... 13

Continuous run ............................................................................................................................................ 14

Short-term centrifugation........................................................................................................................... 14

16 Emergency Stop................................................................................................................................ 15

17 Acoustic Signal .................................................................................................................................. 15

18 Cooling (only in centrifuges with cooling)..................................................................................... 15

Standby-cooling ......................................................................................................................................... 15

Pre-cooling the rotor .................................................................................................................................. 15

19 Relative centrifugal force (RCF)...................................................................................................... 16

20 Centrifugation of materials or mixtures of materials with a density higher than 1.2 kg/dm3. 16

21 Rotor Identification ........................................................................................................................... 16

22 Emergency release........................................................................................................................... 17

23 Maintenance and servicing ............................................................................................................ 17

Centrifuge (housing, lid and centrifuging chamber) ............................................................................ 17

Surface cleaning and care................................................................................................................. 17

THARMAC® GmbH - Cellspin® II/IIR - Instruction

manual

Surface disinfection.............................................................................................................................. 17

Removal of radioactive contaminants ............................................................................................. 18

Rotors and Attachments............................................................................................................................ 18

Cleaning and care............................................................................................................................... 18

Disinfection .................................................................................................................................................. 18

Removal of radioactive contaminants ............................................................................................. 19

Trunnions ................................................................................................................................................ 19

Rotors and accessories with limited service lives ............................................................................. 19

Autoclaving ................................................................................................................................................. 19

Centrifuge containers ................................................................................................................................ 19

24 Faults ................................................................................................................................................... 20

25 Acceptance of the centrifuges for repair..................................................................................... 21

26 Disposal............................................................................................................................................... 21

27 Introduction........................................................................................................................................ 22

28 Assembling and disassembling of Cellfunnel® preparation system .......................................... 23

29 Assembling and disassembling of the ECOfunnel® preparation system.................................. 26

30 Cleaning reusable Cellfunnel® or ECOfunnel® and CellClips .................................................. 29

31 Installation and removal of rotor hub (E) ....................................................................................... 30

Removable rotor 370 .................................................................................................................................. 31

Closed CellClip-rotor 101 ........................................................................................................................... 32

Cleaning the closed CellClip-rotor ........................................................................................................... 34

32 Application field for Cellspin® Cytocentrifuge ............................................................................ 36

33 Instruction for processing of different body fluids with Cellspin® Cytocentrifuge................... 37

34 Additional information...................................................................................................................... 43

35 Prevention of inaccurate results ..................................................................................................... 44

36 Recommended times and speed .................................................................................................. 45

37 Declaration of conformity................................................................................................................ 47

38 Conversion table............................................................................................................................... 48

39 Consumables for Cellspin® Cytocentrifuge ................................................................................ 49

THARMAC® GmbH - Cellspin® II/IIR - Instruction

manual

THARMAC® GmbH - Cellspin® II/IIR - Instruction

manual

1 Use according to specification

The machine presented here is a medical product (laboratory centrifuge) according to the IVD guideline 98/79/EG.

The centrifuge is used to separate substances or substance mixtures with a density of max. 1.2 kg/dm³. This also

includes substances and substance mixtures of human origin. The centrifuge is only intended to be used for this

purpose. A different use or application over and above this is deemed not in accordance with the specifications. The

company THARMAC Cellspin® GmbH undertakes no liability for damages resulting therefrom.

Belonging to the application according to specification is also the observance of all references contained in the

Instruction Manual and compliance with the inspection and maintenance works.

2 Remaining risks

The device is built according to the state-of-the-art and the recognized safety regulations. If used and handled

improperly, there could be life-threatening danger to the user or third parties, or the device could be impaired or there

could be other property damage. The device is only to be used for its intended purpose and only when it is in safe

working condition.

Malfunctions which could affect safety must be corrected immediately.

3 Technical specifications

Manufacturer

THARMAC® GmbH, D-35647 Waldsolms

Model

Cellspin® II

Cellspin® IIR

Type

1401

1401-01

1406

1406-01

Mains voltage (+/- 10%)

200-240 V 1~

100-127 V 1~

200-240 V 1~

240 V 1~

115-127 V 1~

Mains frequency

50-60 Hz

50 Hz

60 Hz

Connected load

400 VA

800 VA

950 VA

Current consumption

2.0 A

4.0 A

8.0 A

Cooling medium

R 404A

Max. capacity

4x 200 ml

Allowed density

1.2 kg/dm³

Speed (RPM)

16000

Force (RCF)

24900

Kinetic force

9500 Nm

Obligatory inspection (DGUV Regel

100-500)

Ambient conditions (EN/IEC 61010-1)

- Set-up site

Indoors only

- Altitude

Up to 2000 m above sea level

- Ambient temperature

2 °C to 35 °C

5 °C to 35 °C

- Humidity

Maximum relative humidity 80% for temperatures up to 31 °C, linearly decreasing to 50% relative

humidity at 40 °C

- Excess-voltage category (IEC

60364-4-443)

- Pollution degree

Device protection class

Not suitable for use in explosion-endangered areas

EMC

- Emitted interference,

Interference immunity

EN / IEC 61326-1,

Class B

FCC Class B

EN / IEC 61326-1, Class B

Class B

Noise level (dependent on rotor)

≤ 68 dB(A)

≤ 64 dB(A)

Dimensions

- Width

401 mm

407 mm

- Depth

529 mm

698 mm

- Height

346 mm

Weight

Approx. 31 kg

Approx. 52 kg

THARMAC® GmbH - Cellspin® II/IIR - Instruction

manual

Manufacturer

THARMAC® GmbH, D-35647 Waldsolms

Model

Cellspin® IIR

Type

1406-50

1406-51

1406-70

1406-71

Mains voltage (+/- 10%)

200-240 V 1~

100-127 V 1~

200-240 V 1~

115-127 V 1~

Mains frequency

50-60 Hz

50 - 60 Hz

Connected load

400 VA

Current consumption

2.0 A

4.0 A

2.0 A

4.0 A

Cooling medium

R 404A

Max. capacity

4x 200 ml

Allowed density

1.2 kg/dm³

Speed (RPM)

16000

Force (RCF)

24900

Kinetic force

9500 Nm

Obligatory inspection (DGUV Regel

100-500)

Ambient conditions (EN/IEC 61010-1)

- Set-up site

Indoors only

- Altitude

Up to 2000 m above sea level

- Ambient temperature

2 °C to 35 °C

- Humidity

Maximum relative humidity 80% for temperatures up to 31 °C, linearly decreasing to 50% relative

humidity at 40 °C

- Excess-voltage category (IEC

60364-4-443)

- Pollution degree

Device protection class

Not suitable for use in explosion-endangered areas

EMC

- Emitted interference,

Interference immunity

EN / IEC 61326-1,

Class B

FCC Class B

EN / IEC 61326-1, Class B

Class B

Noise level (dependent on rotor)

≤ 64 dB(A)

Dimensions

- Width

401 mm

407 mm

- Depth

529 mm

698 mm

- Height

346 mm

Weight

Approx. 35 kg

Manufacturer

THARMAC® GmbH, D-35647 Waldsolms

Model

Cellspin® IIR

Type

1406-20

1406-21

Mains voltage (+/- 10%)

200-240 V 1~

240 V 1~

115-127 V 1~

Mains frequency

50 Hz

60 Hz

Connected load

800 VA

950 VA

Current consumption

4.0 A

8.0 A

Cooling medium

R 404A

Max. capacity

4x 200 ml

Allowed density

1.2 kg/dm³

Speed (RPM)

16000

Force (RCF)

24900

Kinetic force

9500 Nm

Obligatory inspection (DGUV Regel

100-500)

Ambient conditions (EN/IEC 61010-1)

- Set-up site

Indoors only

- Altitude

Up to 2000 m above sea level

- Ambient temperature

2 °C to 35 °C

- Humidity

Maximum relative humidity 80% for temperatures up to 31 °C, linearly decreasing to 50% relative

humidity at 40 °C

- Excess-voltage category (IEC

60364-4-443)

- Pollution degree

Device protection class

Not suitable for use in explosion-endangered areas

EMC

- Emitted interference,

Interference immunity

EN / IEC 61326-1, Class B

Class B

Noise level (dependent on rotor)

≤ 64 dB(A)

Dimensions

- Width

407 mm

- Depth

725 mm

- Height

356 mm

Weight

Approx. 52 kg

THARMAC® GmbH - Cellspin® II/IIR - Instruction

manual

4 Notes on safety

Before the initial operation of your centrifuge you should read and pay attention to the operating

instructions. Only personnel that has read and understood the operating instructions are allowed to

operate the device.

Along with the operating instructions and the legal regulations on accident prevention, you should also follow the

recognized professional regulations for working in a safe and professional manner. These operating instructions

should be read in conjunction with any other instructions concerning accident prevention and environmental

protection based on the national regulations of the country where the device is to be used.

This centrifuge is a state-of-the-art piece of equipment which is extremely safe to operate. However, it can lead to

danger for users or others if used by untrained staff, in an inappropriate way or for a purpose other than that it

was designed for.

The centrifuge must not be moved or knocked during operation.

In case of fault or emergency release, never touch the rotor before it has stopped turning.

To avoid damage due to condensate, when changing from a cold to a warm room the centrifuge must either heat

up for at least 3 hours in the warm room before being connected to the mains, or run hot for 30 minutes in the

cold room.

The centrifuge rotor may only be loaded in accordance with the chapter "Loading the rotor".

When centrifuging with maxim revolutions per minute the density of the materials or the material mixtures may not

exceed 1.2 kg/dm3.

The centrifuge may only be operated when the balance is within the bounds of acceptability.

The centrifuge may not be operated in explosion-endangered areas.

The centrifuge must not be used with:

inflammable or explosive materials

materials that react with one another producing a lot of energy.

The centrifuge should be installed on a good, stable base.

Before using the centrifuge absolutely check the rotor for firm placement.

When the centrifuge is running, according to EN / IEC 61010-2-020, no persons, dangerous

substances or objects may be within the safety margin of 300 mm around the centrifuge.

Rotors, suspensions and accessories that possess traces of corrosion or mechanical damage or

if their term of use has expired may not be used any longer.

The centrifuge may no longer be put into operation when the centrifuging chamber has safety-

related damages.

With swing-out rotors the trunnions must be regularly lubricated in order to ensure

consistent swinging out of the hangers.

For centrifuges without temperature control, when the room temperature is increased and/or if the

device is frequently used, the centrifuging chamber could be heated up. Therefore, it can't be

ruled out that the sample material might be changed due to the temperature.

No claim of warranty will be considered by the manufacturer unless ALL instructions in this manual

have been followed.

THARMAC® GmbH - Cellspin® II/IIR - Instruction

manual

When centrifuging hazardous substances or mixtures, which are toxic, radioactive or contaminated with pathogenic

microorganisms, suitable measures must be taken by the user. Fundamentally, centrifuge containers with special screw

closures must be used for hazardous substances. For materials of risk groups 3 and 4, in addition to sealable centrifuge

containers, a bio-safety system must be used (see the "Laboratory Bio-safety Manual" from the World Health Organization).

In a bio-safety system, a bio-seal (sealing ring) prevents droplets and aerosols from escaping. If the hanger of a bio-safety

system is used without the lid, the sealing ring must be removed from the hanger to prevent damage to the sealing ring

during the centrifugation run. Damaged bio-safety systems are no longer microbiologically sealed.

If a bio-safety system is not used, a centrifuge is not microbiologically sealed for the purposes of the standard EN / IEC

61010-2-020.

When closing a bio-safety system, follow the instructions in the chapter "Handling of bio-safety systems".

For the available bio-safety systems, see the chapter "Appendix, Rotors and accessories". If in doubt, you can get the

information you need from the manufacturer..

The centrifuge must not be operated with highly corrosive substances which could impair the mechanical integrity

of rotors, hangers and accessories.

Repairs must only be carried out by personnel authorized to do so by the manufacturer.

Only original spare parts and original accessories licensed by THARMAC® GmbH.

The following safety regulations apply:

EN / IEC 61010-1 and EN / IEC 61010-2-020 as well as their national deviations.

The safe operation and reliability of the centrifuge can only be guaranteed if:

the centrifuge is operated in accordance with the operating instructions,

the electrical installation on the site where the centrifuge is installed conforms to the demands of EN / IEC

stipulations,

the tests for device safety required in the respective countries, e.g. in Germany in acc. with BGV A1 and BGR

500, are carried out by an expert.

THARMAC® GmbH - Cellspin® II/IIR - Instruction

manual

5 Symbol meanings

Symbol on the device:

Attention, general hazard area.

Before using the device, make sure you read the operating instructions and observe the safety

information!

Symbol in this document:

Attention, general hazard area.

This symbol refers to safety relevant warnings and indicates possibly dangerous situations.

The non-adherence to these warnings can lead to material damage and injury to personal.

Symbol on the device and in this document:

Beware of biohazard.

Symbol in this document:

This symbol refers to important circumstances.

Symbol on the device and in this document:

Symbol for the separate collection of electric and electronic devices according to the guideline

2002/96/EG (WEEE). The device belongs to Group 8 (medical devices).

Applies in the countries of the European Union, as well as in Norway and Switzerland.

6 Delivery checklist

The following items and accessories are delivered with the centrifuge:

1Connecting cable

1 Hex. pin driver

1Notes on moving the equipment safely

1Operating instructions

1Lubricating grease for trunnions

The rotor(s) and associated accessories are included in the delivery in the quantity.

7 Unpacking the centrifuge

Lift the carton upward and remove the padding.





Lift the centrifuge on both sides with an appropriate number of helpers and place it on the laboratory table.

Do not lift by the handle rail.

Observe the weight of the centrifuge, refer to chapter "Technical specifications".

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