Sigma 3-16L User manual

Original operating manual
sb
03/2014
Rev. 2.22 of 24/10/2023
Sigma 3-16L;Laboratory Centrifuge;Sigma 3-16L IVD
Laboratory Centrifuge
part no. 0700902
Sigma 3-16L
Sigma 3-16L IVD
from serial no. 146284
Laboratory Centrifuge
Operating Manual
Please retain for later use!

Laboratory Centrifuge Sigma 3-16L
Laboratory Centrifuge Sigma 3-16L IVD
2 / 84
Version 03/2014, Rev. 2.22 of 24/10/2023 • sb
Original operating manual, part no. 0700902

Laboratory Centrifuge Sigma 3-16L
Laboratory Centrifuge Sigma 3-16L IVD
Version 03/2014, Rev. 2.22 of 24/10/2023 • sb
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Original operating manual, part no. 0700902
© Copyright by
Sigma Laborzentrifugen GmbH
An der Unteren Söse 50
37520 Osterode am Harz
Germany
Tel.: [phone] / 5007-0
Fax: [phone] / 5007-12
Web: www.sigma-zentrifugen.de
E-mail: [e-mail]

Laboratory Centrifuge Sigma 3-16L
Laboratory Centrifuge Sigma 3-16L IVD
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Original operating manual, part no. 0700902

Laboratory Centrifuge Sigma 3-16L
Laboratory Centrifuge Sigma 3-16L IVD
Table of contents
Version 03/2014, Rev. 2.22 of 24/10/2023 • sb
5 / 84
Original operating manual, part no. 0700902
1General information.............................................................................................................9
1.1 Importance of the operating manual..................................................................................9
1.2 Intended use.....................................................................................................................9
1.3 Warranty and liability.........................................................................................................9
1.4 Copyright........................................................................................................................10
1.5 Standards and regulations..............................................................................................10
1.6 Scope of supply..............................................................................................................10
2Layout and mode of operation..........................................................................................11
2.1 Layout of the centrifuge ..................................................................................................11
2.1.1 Functional and operating elements............................................................................11
2.1.2 Name plate................................................................................................................12
2.2 Mode of operation...........................................................................................................13
2.2.1 Centrifugation principle..............................................................................................13
2.2.2 Area of application.....................................................................................................13
2.2.2.1 Speed, radius, and relative centrifugal force ......................................................14
2.2.2.2 Density...............................................................................................................14
3Safety..................................................................................................................................15
3.1 Marking of the unit..........................................................................................................15
3.2 Explanation of the symbols and notes.............................................................................16
3.3 Responsibility of the operator..........................................................................................17
3.4 Requirements concerning the personnel.........................................................................18
3.5 Informal safety instructions .............................................................................................19
3.6 Safety instructions ..........................................................................................................20
3.6.1 Electrical safety .........................................................................................................20
3.6.2 Mechanical safety......................................................................................................20
3.6.3 Fire prevention...........................................................................................................21
3.6.4 Chemical and biological safety ..................................................................................21
3.6.5 Safety instructions for centrifugation..........................................................................22
3.6.6 Resistance of plastics................................................................................................22
3.6.7 Safety of rotors and accessories................................................................................23
3.6.7.1 Marking of rotors and accessories......................................................................23
3.6.7.2 Service life (for centrifuges according to Machinery Directive) ...........................23
3.6.7.3 Service life (for centrifuges according to the IVD regulation)..............................24
3.6.7.4 Service life of the Sigma "Comfort" rotor coating................................................25
3.7 Safety devices ................................................................................................................27
3.7.1 Lid lock device...........................................................................................................27
3.7.2 Standstill monitoring system......................................................................................27
3.7.3 System check............................................................................................................27
3.7.4 Earth conductor check...............................................................................................27
3.7.5 Imbalance monitoring system....................................................................................27
3.7.6 Rotor monitoring system............................................................................................27
3.8 Measures in the event of hazards and accidents ............................................................28
3.9 Remaining hazards.........................................................................................................28

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4Storage and transport ....................................................................................................... 29
4.1 Dimensions and weight...................................................................................................29
4.2 Storage conditions..........................................................................................................29
4.3 Notes on transport..........................................................................................................29
4.4 Packaging.......................................................................................................................30
4.5 Transport safety device...................................................................................................30
5Set-up and connection ...................................................................................................... 31
5.1 Installation site................................................................................................................31
5.2 Power supply..................................................................................................................31
5.2.1 Type of connection ....................................................................................................31
5.2.2 Customer-provided fuses...........................................................................................32
6Using the centrifuge.......................................................................................................... 33
6.1 Initial start-up..................................................................................................................33
6.2 Switching the centrifuge on.............................................................................................33
6.2.1 Opening and closing the lid........................................................................................33
6.2.2 Installation of rotors and accessories.........................................................................34
6.2.2.1 Installation of a rotor ..........................................................................................34
6.2.2.2 Installation of an angle rotor with a hermetic lid..................................................35
6.2.2.3 Installation of accessories..................................................................................36
6.2.2.4 Adapters ............................................................................................................37
6.2.2.5 Vessels..............................................................................................................37
6.3 Control system "Spincontrol L"........................................................................................38
6.3.1 User interface............................................................................................................38
6.3.2 Manual mode.............................................................................................................39
6.3.2.1 Starting a centrifugation run...............................................................................39
6.3.2.2 Interrupting a centrifugation run .........................................................................39
6.3.2.3 Interrupting a deceleration process....................................................................39
6.3.2.4 Selection, display, and modification of data........................................................39
6.3.2.5 Speed / relative centrifugal force (RCF) .............................................................40
6.3.2.6 Runtime .............................................................................................................40
6.3.2.7 Rotor selection...................................................................................................42
6.3.2.8 Acceleration and deceleration curves.................................................................43
6.3.2.9 Automatic lid opening function ("AutoOpen")......................................................44
6.3.2.10 Sound signal ("Buzzer").....................................................................................44
6.3.2.11 Program lock ("ProgLock").................................................................................45
6.3.2.12 Cycle display ("Cycles").....................................................................................45
6.3.2.13 Input lock ...........................................................................................................46
6.3.3 Program mode...........................................................................................................47
6.3.3.1 Saving a program...............................................................................................47
6.3.3.2 Loading a program.............................................................................................48
6.4 Switching the centrifuge off.............................................................................................48

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Laboratory Centrifuge Sigma 3-16L IVD
Table of contents
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7Malfunctions and error correction.................................................................................... 49
7.1 General malfunctions......................................................................................................49
7.1.1 Emergency lid release...............................................................................................50
7.2 Table of error codes........................................................................................................51
7.3 Service contact...............................................................................................................52
8Maintenance and service................................................................................................... 53
8.1 Maintenance...................................................................................................................53
8.1.1 Centrifuge..................................................................................................................53
8.1.2 Accessories...............................................................................................................54
8.1.2.1 Plastic accessories ............................................................................................54
8.1.3 Rotors, buckets and carriers......................................................................................55
8.1.3.1 Load bearing bolts .............................................................................................56
8.1.4 Glass breakage .........................................................................................................57
8.2 Sterilisation and disinfection of the rotor chamber and accessories ................................57
8.2.1 Autoclaving................................................................................................................58
8.3 Service ...........................................................................................................................59
8.4 Return of defective centrifuges or parts ..........................................................................60
9Disposal.............................................................................................................................. 62
9.1 Disposal of the centrifuge ...............................................................................................62
9.2 Disposal of the packaging...............................................................................................62
10 Technical data.................................................................................................................... 63
10.1 Ambient conditions .........................................................................................................64
10.2 Technical documentation................................................................................................64
11 Appendix............................................................................................................................ 65
11.1 Range of accessories .....................................................................................................65
11.1.1 Rotor radii..................................................................................................................65
11.2 Speed-gravitational-field-diagram ...................................................................................66
11.3 Acceleration and deceleration curves .............................................................................67
11.4 Table of the service life of rotors and accessories...........................................................68
11.5 Resistance data..............................................................................................................69
11.6 EC declaration of conformity...........................................................................................73
11.7 Declaration of conformity –China RoHS 2......................................................................77
11.8 UKCA declaration of conformity......................................................................................79
12 Index................................................................................................................................... 81

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1 General information
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1 General information
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1.1 Importance of the operating manual
A fundamental requirement for the safe and trouble-free operation of the
centrifuge is to be familiar with the fundamental safety instructions and all
possible hazards.
The operating manual includes important information concerning the safe
operation of the centrifuge.
This operating manual and, in particular, the notes on safety and hazards
must be observed by all persons operating the centrifuge.
In addition, the local rules and regulations for the prevention of accidents
must be complied with.
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1.2 Intended use
The laboratory centrifuge is suitable for the separation of constituents of
different densities in mixtures with a maximum density of 1.2 g/cm3.
The laboratory centrifuge that is marked with IVD is intended for human
biological samples, including donated blood and tissue, in conjunction with
diagnostic in-vitro applications. This means that it is a medical product in
accordance with Regulation (EU) 2017/746 on in vitro diagnostica.
Only trained, specialised personnel are authorised to use the centrifuge in
closed laboratories.
The intended use also includes:
•observation of all of the notes and instructions that are included in the
operating manual and
•compliance with the inspection and maintenance instructions.
Sigma Laborzentrifugen GmbH cannot be held liable for:
•damage resulting from the improper use of the centrifuge not in line with
its intended purpose,
•faulty results that are due to the incorrect or faulty procedures of the
user.
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1.3 Warranty and liability
The warranty and liability are subject to our "General Conditions" that were
distributed to the operator upon the conclusion of the contract.
Warranty and liability claims are excluded if they are due to:
•improper use.
•non-compliance with the safety instructions and hazard warnings in the
operating manual.
•improper installation, start-up, operation, or maintenance of the
centrifuge.
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1.4 Copyright The copyright concerning the operating manual remains with
Sigma Laborzentrifugen GmbH.
The operating manual is solely intended for the operator and their
personnel. It includes instructions and information that must not be
•duplicated,
•distributed, or
•communicated in any other way.
Non-compliance may be prosecuted under criminal law.
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1.5 Standards and regulations
These operating instructions have been created in accordance with the
relevant European standards and regulations (see chapter 11.6 - "EC
declaration of conformity").
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1.6 Scope of supply
The centrifuge comprises:
•1 power cord with an IEC C13 connector
•1 rotor wrench
Part no. 930 100
•1 tube (30 g) heavy-duty grease for load-
bearing bolts
Part no. 71 401
Documentation
Operating manual incl. EC declaration of conformity
(see chapter 11.6 - "EC declaration of conformity")
Accessories
According to your order, our order confirmation, and your delivery note.
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2 Layout and mode of operation
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2 Layout and mode of operation
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2.1 Layout of the centrifuge
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2.1.1 Functional and operating elements
1 Lid
2 User interface (see
chapter 6.3.1 - "User
interface")
3 Mains switch
Fig. 1: Total view of the centrifuge
4 Name plate
(see chapter 2.1.2 -
"Name plate")
5 Mains power input
Fig. 2: Rear view of the centrifuge
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2.1.2 Name plate
1 Manufacturer
2 Power consumption
3 Max. speed
4 Max. kinetic energy
5 Serial number
6 Part number
7 Nominal voltage
8 Type
9 Consult operating
manual
10 Symbol for special
disposal (see chapter
9 - "Disposal")
11 IVD mark
(if applicable)
12 Date of manufacture
13 CE mark in
compliance with the
directive 2006/42/EC
14 Max. permissible
density
Fig. 3: Example of a name plate
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2.2 Mode of operation
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2.2.1 Centrifugation principle
Centrifugation is a process for the separation of heterogeneous mixtures of
substances (suspensions, emulsions, or gas mixtures) into their
components. The mixture of substances, which rotates on a circular path, is
subject to centripetal acceleration that is several times greater than the
gravitational acceleration.
Centrifuges use the mass inertia inside the rotor chamber for separating the
substances. Due to their higher inertia, particles or media with a higher
density travel outwards. In doing so, they displace the components with a
lower density, which in turn travel towards the centre.
The centripetal acceleration of an object inside a centrifuge, as the effect of
centripetal force, depends on the distance between the object and the axis
of rotation as well as on the angular velocity. It increases linearly as a
function of the distance with regard to the axis of rotation and quadratically
as a function of the angular velocity. The bigger the radius in the rotor
chamber is and the higher the speed is, the higher the centripetal
acceleration is. However, the forces acting on the rotor also increase.
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2.2.2 Area of application
Depending on the area of application of the centrifuge and also on the
particle size, solids content, and volume throughput of the mixture of
substances that is to be centrifuged, there are different types of centrifuges.
The areas of application go from household use as a salad spinner or
honey separator up to specialised technical applications in the clinical,
biological, or biochemical context:
•For numerous clinical examinations, cellular material must be separated
from the liquid to be analysed. The normal separation process can be
sped up considerably by using laboratory centrifuges.
•In the metal-working industry, centrifuges are used for separating oil
from metal cuttings. Dairies use centrifuges in order to separate cow’s
milk into cream and low-fat milk.
•Particularly big centrifuges are used in the sugar industry for separating
the syrup from the crystalline sugar.
•Ultracentrifuges are predominantly used in biology and biochemistry in
order to isolate particles, e.g. viruses. They are specifically designed for
high speeds up to 500,000 rpm. The rotor moves in a vacuum in order
to avoid air friction.
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2.2.2.1 Speed, radius, and relative centrifugal force
The acceleration g, which the samples are subject to, can be increased by
increasing the radius in the rotor chamber and by increasing the speed.
These three parameters are interdependent and linked with each other via
the following formula:
Relative centrifugal force RCF = 11.18 x 10-6 x r x n2
r = radius in cm
n = speed in rpm
RCF without any dimension
If two values are entered, the third value is determined by way of the stated
formula. If, afterwards, the speed or the radius is changed, the resulting
relative centrifugal force will be recalculated automatically by the control
unit. If the RCF is changed, the speed will be adapted while the specified
radius is maintained.
The speed-gravitational-field-diagram provides an overview of the
relationship between speed, radius, and RCF (see chapter 11.2 - "Speed-
gravitational-field-diagram").
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2.2.2.2 Density The laboratory centrifuge is suitable for the separation of constituents of
different densities in mixtures with a maximum density of 1.2 g/cm3. All
information concerning the speed of rotors and accessories refers to liquids
with a density corresponding to this specification. If the density is above this
value, the maximum permissible speed of the centrifuge must be reduced
based on the following formula:
n = nmax x √(1.2/𝜌)
𝜌= density in g/cm3
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3 Safety
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3.1 Marking of the unit
The following symbols are used on this centrifuge:
I
On (Power)
Arrow indicating the direction of
rotation
0
Off (Power)
Rotor loading information
(see chapter 6.2.2.3 -
"Installation of accessories")
Name plate (see chapter 2.1.2 -
"Name plate")
CE mark in compliance with the
directive 2006/42/EC
Do not dispose as part of
domestic waste
Consult operating manual
Medical product in accordance
with the regulation
(EU) 2017/746
NRTL mark (only for the USA
and Canada)
RCM mark
(only for Australia)
China RoHS 2 mark
(only for China)
California Proposition 65 mark
(only for the USA)
UKCA mark
(only for UK)
NOTE
Safety indications on the centrifuge must be kept readable at all times. If
necessary, they must be replaced.
NOTE
The marking varies depending on the version and country of destination of
the centrifuge.
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3.2 Explanation of the symbols and notes
In this operating manual, the following names and symbols to indicate
hazards are used:
DANGER
This symbol stands for a direct hazard to the life and health of persons.
Non-observance of these symbols causes serious health problems up to
life-endangering injuries.
DANGER
This symbol stands for a direct hazard to the life and health of persons
due to electrical voltage.
Non-observance of these symbols causes serious health problems up to
life-endangering injuries.
WARNING
This symbol stands for a potential hazard to the life and health of
persons.
Non-observance of these symbols can cause serious health problems up
to life-endangering injuries.
CAUTION
This symbol indicates a potentially hazardous situation
Non-observance of these notes can cause minor injuries or damage to
property.
NOTE
This symbol indicates important information.
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3.3 Responsibility of the operator
The operator undertakes to authorise only trained, specialised personnel to
work on the centrifuge chapter 3.4 - "Requirements concerning the
personnel".
The areas of responsibility of the personnel concerning the operation,
maintenance, and care of the unit must be clearly defined.
The safety-conscious work of the personnel in compliance with the
operating manual and the relevant EC health and safety directives, and the
national laws concerning health and safety and the prevention of accidents
must be checked at regular intervals (e.g. every month).
Under the international rules for health and safety at work, the operator is
obliged to:
•take measures in order to prevent danger to life or health during work.
•ensure that the centrifuges are used properly and entirely as intended
(see chapter 1.2 - "Intended use").
•take protective measures against fire and explosion when working with
hazardous substances.
•take measures for the safe opening of the centrifuges.
The operator must perform a risk assessment concerning potential
accidents in connection with the centrifuge and take design-related
countermeasures, if necessary.
The operator must inform the users that any serious event which either
directly or indirectly had, could have had or could have one of the following
consequences must be reported to the manufacturer or competent
authority:
a) The death of a patient, user or other person,
b) the temporary or permanent degradation of the health of a patient, user
or other person,
c) a serious risk to public health.
The centrifuge has to be maintained regularly (see chapter 8 -
"Maintenance and service").
Components that are not in a perfect state must be replaced immediately.
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3.4 Requirements concerning the personnel
DANGER
Risk of injury if the personnel are not sufficiently qualified
If unqualified personnel perform work on the centrifuge or are present in
the danger zone of the centrifuge, hazards result that can cause serious
injuries and considerable damage to property.
•Ensure that all the tasks are performed by personnel with the
corresponding qualifications.
•Ensure that unqualified personnel stay clear of the danger zones.
DANGER
Risk of fatal injury to unauthorised persons due to hazards in the
danger zone or work area
Unauthorised persons who do not fulfil the requirements described herein
are not aware of the hazards in the work area. This is why there is a risk
of serious or even fatal injuries for unauthorised persons.
•Ensure that unauthorised persons stay clear of the danger zone and
work area.
•If in doubt, address these persons and instruct them to leave the
danger zone and work area.
•Interrupt any running work if unauthorised persons are present in the
danger zone or work area.
This manual uses the following personnel qualifications for various areas of
activity:
Qualified electrician
Due to their special training, knowledge, experience and familiarity with the
relevant standards and regulations, qualified electricians are in the position
to perform work on electrical systems and to autonomously identify and
prevent possible hazards.
Qualified electricians have been specifically trained for the environment in
which they work and they are familiar with all the relevant standards and
regulations.
Qualified electricians must fulfil the requirements as set out in the
applicable legal provisions concerning the prevention of accidents.
Specialised personnel
Due to their special training, knowledge, experience and familiarity with the
relevant regulations, specialised personnel are in the position to perform
any tasks assigned to them and to autonomously identify and prevent
possible hazards.
Operating personnel
Only trained, specialised personnel are authorised to operate the unit. The
persons operating the unit must
•be familiar with the fundamental health, safety, and accident prevention
regulations,
•have read and understood this operating manual, in particular the safety
sections and warning notes, and confirmed this with their signature,
•have been instructed in the operation and maintenance of this
centrifuge.

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3 Safety
Version 03/2014, Rev. 2.22 of 24/10/2023 • sb
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Original operating manual, part no. 0700902
The operating personnel must ensure that any serious event which either
directly or indirectly had, could have had or could have one of the following
consequences will be reported to the manufacturer or competent authority:
a) The death of a patient, user or other person,
b) the temporary or permanent degradation of the health of a patient, user
or other person,
c) a serious risk to public health.
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3.5 Informal safety instructions
•This operating manual is a part of the product.
•The operating manual must be kept at the location of use of the
centrifuge. Ensure that it is accessible at all times.
•The operating manual must be handed over to any subsequent owner
or operator of the centrifuge.
•Any changes, additions or updates received must be added to the
operating manual.
•In addition to the operating manual, the general and local rules and
regulations concerning the prevention of accidents and the protection of
the environment must also be supplied.
•Safety and danger indications on the centrifuge must be kept readable
at all times. If necessary, they must be replaced.
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3.6 Safety instructions
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3.6.1 Electrical safety
As protection against electric shock, the centrifuge is equipped with an
earthed mains power cable and connector. To ensure the effectiveness of
this safety feature, the following must be ensured:
DANGER
•Ensure that the wall socket is properly wired and grounded.
•Check that the mains voltage agrees with the nominal voltage listed on
the name plate.
•Ensure that the mains power cable is intact prior to using the
centrifuge. Damaged or faulty mains power cables must be replaced
immediately.
•Do not place vessels containing liquid on the centrifuge lid or within
the safety distance of 30 cm around the centrifuge. Spilled liquids may
get into the centrifuge and damage electrical or mechanical
components.
•Only qualified and specialised personnel are authorised to perform
service tasks or repairs of the electrical system for which the housing
needs to be removed.
•Inspect the electrical equipment of the unit regularly. Defects such as
loose or burnt cables must be eliminated immediately.
•Following the completion of any type of repair or service, the qualified
and specialised personnel must perform final inspection and testing in
compliance with the relevant standards.
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3.6.2 Mechanical safety
In order to ensure the safe operation of the centrifuge, observe the
following:
WARNING
•Do not open the lid when the rotor is in motion!
•Do not reach into the rotor chamber when the rotor is in motion!
•Do not use the centrifuge if it was installed incorrectly.
•Do not use the centrifuge without panels.
•Do not use the centrifuge if the rotors and inserts show signs of
corrosion or other defects.
•Only use the centrifuge with rotors and accessories that have been
approved by the manufacturer. In case of doubt, contact the
manufacturer (see chapter 7.3 - "Service contact").
•Do not hold your fingers between the lid and the housing when closing
the lid. Risk of crushing!
•Defective lid relieving devices could cause the centrifuge lid to fall
(contact the service department, if necessary). Risk of crushing!
•Do not hit or move the centrifuge during its operation.
•Do not lean against or rest on the centrifuge during its operation.