Hettich Universal 320 User manual

Rev. 00 / 02.2021 Andreas Hettich GmbH & Co. KG AB1401EN_SA

UNIVERSAL 320

UNIVERSAL 320 R

Operating Instructions.................................................... 5

2/64 Rev. 00 / 02.2021 AB1401EN_SA

Fig. 1

>RCF< RPM t/min

RCF SELECT START

IMPULS STOP

OPEN

Fig. 2 UNIVERSAL 320

>RCF< RPM t/min

RCF SELECT START

IMPULS STOP

OPEN

T/°C

Fig. 3 UNIVERSAL 320 R

AB1401EN_SA Rev. 00 / 02.2021 3/64

Standards and regulations which apply to this device

The device is a high-end technical product. It is subject to extensive testing and certification procedures according to

the following standards and regulations in their respectively valid version:

Electrical and mechanical safety for design and final testing:

Standard series: IEC 61010 (conform to standards of DIN EN 61010)

 IEC 61010-1 “Safety requirements for electrical equipment for measurement, control, and laboratory use -

Part 1: General requirements” (Pollution Degree 2, Excess-voltage category II)

 IEC 61010-2-010 „Safety requirements for electrical equipment for measurement, control and laboratory use

- Part 2-010: Particular requirements for laboratory equipment for the heating of Materials” (only valid for

centrifuges with heating)

 IEC 61010-2-011 „Safety requirements for electrical equipment for measurement, control and laboratory use

- Part 2-011: Particular requirements for refrigerating equipment” (only valid for centrifuges with cooling)

 IEC 61010-2-020 “Safety requirements for electrical equipment for measurement, control, and laboratory

use - Part 2-020: Particular requirements for laboratory centrifuges”

 IEC 61010-2-101 ”Safety requirements for electrical equipment for measurement, control and laboratory use

- Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment“

Electromagnetic Compatibility:

 EN 61326-1 “Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1:

General requirements“

Risk management:

 DIN EN ISO 14971 “Application of risk management to medical devices”

Restriction of Hazardous Substances (RoHS II):

 EN 50581 "Technical documentation for assessing electric and electronic devices with regard to the

restriction of hazardous substances"

European directives applied for conformity assessment procedures:

 In vitro diagnostic device directive 98/79/EG

EC conformity assessment procedure according to annex III “EC DECLARATION OF CONFORMITY“ –

self-declaration by the manufacturer

 Directive 2011/65/EU for the restriction of use of certain hazardous substances in electric and electronic

devices. Carrying out the EC conformity assessment process is the sole responsibility of the manufacturer,

without the involvement of a notified body.

Applied medical device regulations outside Europe:

 USA: QSR, 21CFR 820 “CFR Title 21 - Food and Drugs: TITLE 21- FOOD AND DRUGS, CHAPTER I -

FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES,

SUBCHAPTER H - MEDICAL DEVICES, Part 820 QUALITY SYSTEM REGULATONS“

 Canada: CMDR, SOR/98-282 “Medical Devices Regulations”

Certified quality management system according to

 ISO 9001 “Quality management systems – Requirements”

 ISO13485 “Medical devices - Quality management systems - Requirements for regulatory purposes”

Environmental management system according to

 ISO 14001 “Environmental management systems - Requirements with guidance for use”

4/64 Rev. 00 / 02.2021 AB1401EN_SA

Andreas Hettich GmbH & Co. KG

Föhrenstraße 12, D-78532 Tuttlingen / Germany

Phone +49 (0)7461 / 705-0

Fax +49 (0)7461 / 705-1125

[email protected], servi[email protected]

www.hettichlab.com

owner.

Änderungen vorbehalten! , Modifications reserved! , Sous réserve de modifications ! , Con riserva di modifiche!

AB1401EN / Rev. 00

AB1401EN_SA Rev. 00 / 02.2021 5/64

Contents

1Use according to specification................................................................................................................................7

2Remaining risks......................................................................................................................................................7

3Technical specifications..........................................................................................................................................7

4Notes on safety.....................................................................................................................................................10

5Transport and storage...........................................................................................................................................11

5.1 Transport.......................................................................................................................................................11

5.2 Storage..........................................................................................................................................................11

6Symbol meanings .................................................................................................................................................11

7Delivery checklist..................................................................................................................................................12

8Unpacking the centrifuge......................................................................................................................................12

9Initial operation .....................................................................................................................................................13

10 Opening and closing the lid...............................................................................................................................13

10.1 Opening the lid...........................................................................................................................................13

10.2 Closing the lid ............................................................................................................................................13

11 Installation and removal of the rotor..................................................................................................................14

11.1 Rotor with clamping nut..............................................................................................................................14

11.2 Rotor without clamping nut.........................................................................................................................14

11.2.1 Installing and removing the hub..........................................................................................................14

11.2.2 Inserting and removing the rotor.........................................................................................................14

12 Inserting and removing hangers into/from the rotor...........................................................................................15

13 Inserting and removing the adapters into/from the hangers ..............................................................................15

14 Inserting the adapter with positioning pin into the hanger .................................................................................15

15 Loading the rotor...............................................................................................................................................16

16 Handling of bio-safety systems..........................................................................................................................17

16.1 Opening and closing the lid of bio-safety systems .....................................................................................17

16.1.1 Lid with screw top and hole in turning handle .....................................................................................17

16.1.2 Lid with screw closure.........................................................................................................................18

16.1.3 Lid with clamp and tension lock ..........................................................................................................18

16.2 Storage of bio-safety systems....................................................................................................................18

17 Control and display elements............................................................................................................................18

17.1 Control knob...............................................................................................................................................19

17.2 Control panel pushbuttons (keys) ..............................................................................................................19

17.3 Adjustment possibilities..............................................................................................................................19

18 Entering centrifugation parameter.....................................................................................................................20

19 Programming.....................................................................................................................................................20

19.1 Programme input/alteration........................................................................................................................20

19.2 Programme recall.......................................................................................................................................20

20 Centrifugation....................................................................................................................................................20

20.1 Centrifugation with pre-set time .................................................................................................................21

20.2 Continuous run...........................................................................................................................................21

20.3 Short-term centrifugation............................................................................................................................21

21 Emergency Stop................................................................................................................................................21

22 Acoustic Signal..................................................................................................................................................21

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23 Recall hours of operation ..................................................................................................................................21

24 Cooling (only in centrifuges with cooling)..........................................................................................................22

24.1 Standby-cooling.........................................................................................................................................22

24.2 Pre-cooling the rotor ..................................................................................................................................22

25 Relative centrifugal force (RCF)........................................................................................................................22

26 Centrifugation of materials or mixtures of materials with a density higher than 1.2 kg/dm3...............................23

27 Rotor recognition...............................................................................................................................................23

28 Emergency release ...........................................................................................................................................23

29 Maintenance and servicing................................................................................................................................24

29.1 Centrifuge (housing, lid and centrifuging chamber)....................................................................................24

29.1.1 Surface cleaning and care..................................................................................................................24

29.1.2 Surface disinfection ............................................................................................................................24

29.1.3 Removal of radioactive contaminants.................................................................................................24

29.2 Rotors and Attachments ............................................................................................................................25

29.2.1 Cleaning and care...............................................................................................................................25

29.2.2 Disinfection.........................................................................................................................................25

29.2.3 Removal of radioactive contaminants.................................................................................................25

29.2.4 Trunnions............................................................................................................................................26

29.2.5 Rotors and accessories with limited service lives...............................................................................26

29.3 Autoclaving ................................................................................................................................................26

29.4 Centrifuge containers.................................................................................................................................26

30 Faults ................................................................................................................................................................27

31 Returning Devices.............................................................................................................................................28

32 Disposal ............................................................................................................................................................28

33 Anhang / Appen ................................................................................................................................................29

33.1 Rotoren und Zubehör / Rotors and accessories.........................................................................................29

AB1401EN_SA Rev. 00 / 02.2021 7/64

1 Use according to specification

This device is a medical product (laboratory centrifuge) within the context of the IVD Directive 98/79/EC.

The centrifuge was designed only for the separation of materials or mixtures with a density of no more than 1.2

kg/dm³. In particular, these include samples for preparation of in-vitro diagnostic purposes in human medicine.

The centrifuge is only meant for this purpose.

Another use or one which goes beyond this, is considered to be non-intended. The company Andreas Hettich GmbH

& Co. KG is not liable for damage resulting from this.

Observing all information in the operating instructions and complying with the measures described therein is also a

part of the intended use.

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 Andreas Hettich GmbH & Co. KG

D-78532 Tuttlingen

Model UNIVERSAL 320 UNIVERSAL 320 R

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 – 60 Hz 50 Hz 60 Hz 60 Hz

Connected load 400 VA 400 VA 800 VA 950 VA

Current consumption 2.0 A 4.0 A 4.0 A 8.0 A

Cooling medium ---- R452A

Max. capacity 4 x 200 ml

Allowed density 1.2 kg/dm3

Speed (RPM) 16000

Force (RCF) 24900

Kinetic energy 9800 Nm

Obligatory inspection

(DGUV Regel 100 - 500) no

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 2

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 FCC 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 346 mm

Weight approx. 31 kg approx. 52 kg

8/64 Rev. 00 / 02.2021 AB1401EN_SA

Manufacturer Andreas Hettich GmbH & Co. KG

D-78532 Tuttlingen

Model UNIVERSAL 320 R

Type 1406-50 1406-51 1406-70 1406-71

Mains voltage (10%) 200-240 V 1100-127 V 1200-240 V 1100-127 V 1

Mains frequency 50 – 60 Hz 50 – 60 Hz 50 – 60 Hz 50 – 60 Hz

Connected load 400 VA 400 VA 400 VA 400 VA

Current consumption 2.0 A 4.0 A 2.0 A 4.0 A

Max. capacity 4 x 200 ml

Allowed density 1.2 kg/dm3

Speed (RPM) 16000

Force (RCF) 24900

Kinetic energy 9800 Nm

Obligatory inspection

(DGUV Regel 100 - 500) no

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 2

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 FCC Class B

Noise level (dependent on rotor) 64 dB(A)

Dimensions

 Width 401 mm 401 mm

 Depth 549 mm 550 mm

 Height 346 mm 365 mm

Weight approx. 35 kg

AB1401EN_SA Rev. 00 / 02.2021 9/64

Manufacturer Andreas Hettich GmbH & Co. KG

D-78532 Tuttlingen

Model UNIVERSAL 320 R

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 60 Hz

Connected load 800 VA 950VA

Current consumption 4.0 A 8.0 A

Cooling medium R452A

Max. capacity 4 x 200 ml

Allowed density 1.2 kg/dm3

Speed (RPM) 16000

Force (RCF) 24900

Kinetic energy 9800 Nm

Obligatory inspection

(DGUV Regel 100 - 500) no

Ambient conditions (EN / IEC 61010-1)

 Set-up site Indoors only

 Altitude Up to 2000 m above sea level

 Ambient temperature 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 2

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

Noise level (dependent on rotor) 64 dB(A)

Dimensions

 Width 407 mm

 Depth 725 mm

 Height 365 mm

Weight approx. 52 kg

10/64 Rev. 00 / 02.2021 AB1401EN_SA

4 Notes on safety

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

have been followed.

 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 (Hettich Lubricating Grease No.

4051) 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.

 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

recognised 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.

 Only the rotors and accessories approved by the manufacturer for this device may be used (see chapter

"Anhang/Appendix, Rotoren und Zubehör/Rotors and accessories"). Before centrifuge vessels are used which are

not listed in the chapter "Appendix, Rotors and accessories", the user must make sure they can be used by

asking the manufacturer.

 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.

AB1401EN_SA Rev. 00 / 02.2021 11/64

 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 authorised to do so by the manufacturer.

 Only original spare parts and original accessories licensed by the Andreas Hettich GmbH & Co. KG company are

allowed to be utilised.

 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.

 Meeting the country-specific requirements concerning occupational safety with regard to the use of laboratory

centrifuges at the workplaces provided for this purpose by the user is the responsibility of the user.

5 Transport and storage

5.1 Transport

Before transporting the device, the transport securing device must be installed.

When the device and accessories are transported, the following ambient conditions must be complied with:

 Ambient temperature: -20°C to +60°C

 Relative humidity: 10% to 80%, non-condensing

5.2 Storage

The device and the accessories may only be stored in closed and dry rooms.

When the device and accessories are stored, the following ambient conditions must be complied with:

 Ambient temperature: -20°C to +60°C

 Relative humidity: 10% to 80%, non-condensing

6 Symbol meanings

Symbol on the device:

Attention, general hazard area.

Symbol on the device:

Observe operating instructions.

This symbol indicates that the user must observe the operating instructions provided.

12/64 Rev. 00 / 02.2021 AB1401EN_SA

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.