Sigma 8KBS User manual

Translation of the original operating manual
sb
05/2021
Rev. 1.2 of 28/04/2022
Sigma 8KBS; ;
part no. 0703502
Sigma 8KBS
from serial no. 162923
Blood bank centrifuge
Operating Manual
Please retain for later use!

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© 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]

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Blood bank centrifuge Sigma 8KBS
Table of contents
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1General information.............................................................................................................9
1.1 Importance of the operating manual..................................................................................9
1.2 Further applicable documents...........................................................................................9
1.3 Intended use.....................................................................................................................9
1.4 Warranty and liability.......................................................................................................10
1.5 Copyright........................................................................................................................10
1.6 Standards and regulations..............................................................................................10
1.7 Scope of supply..............................................................................................................10
2Layout and mode of operation..........................................................................................12
2.1 Layout of the centrifuge ..................................................................................................12
2.1.1 Functional and operating elements............................................................................12
2.1.2 Name plate................................................................................................................15
2.2 Mode of operation...........................................................................................................16
2.2.1 Centrifugation principle..............................................................................................16
2.2.2 Area of application.....................................................................................................16
2.2.2.1 Speed, radius, and relative centrifugal force ......................................................17
2.2.2.2 Density...............................................................................................................17
3Safety..................................................................................................................................18
3.1 Marking of the unit..........................................................................................................18
3.2 Explanation of the symbols and notes.............................................................................19
3.3 Responsibility of the operator..........................................................................................20
3.4 Requirements concerning the personnel.........................................................................21
3.5 Informal safety instructions .............................................................................................22
3.6 Safety instructions ..........................................................................................................23
3.6.1 Electrical safety .........................................................................................................23
3.6.2 Mechanical safety......................................................................................................23
3.6.3 Fire prevention...........................................................................................................24
3.6.4 Chemical and biological safety ..................................................................................24
3.6.5 Safety instructions for centrifugation..........................................................................25
3.6.6 Resistance of plastics................................................................................................25
3.6.7 Service life.................................................................................................................26
3.6.8 Rotors and accessories.............................................................................................27
3.6.8.1 Lifting and carrying rotors...................................................................................27
3.6.8.2 Marking..............................................................................................................27
3.7 Safety devices ................................................................................................................28
3.7.1 Lid lock device...........................................................................................................28
3.7.2 Standstill monitoring system......................................................................................28
3.7.3 System check............................................................................................................28
3.7.4 Earth conductor check...............................................................................................28
3.7.5 Imbalance monitoring system....................................................................................28
3.7.6 Temperature monitoring system ................................................................................28
3.7.7 Rotor monitoring system............................................................................................28

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3.8 Measures in the event of hazards and accidents ............................................................29
3.9 Remaining hazards.........................................................................................................29
4Storage and transport ....................................................................................................... 30
4.1 Storage conditions..........................................................................................................30
4.2 Transport........................................................................................................................30
5Set-up and connection ...................................................................................................... 31
5.1 Condensate drain ...........................................................................................................31
5.2 Cover holder...................................................................................................................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 accessories..................................................................................36
6.2.2.3 Adapters ............................................................................................................37
6.2.2.4 Vessels and blood bag systems.........................................................................37
6.3 Control system "Spincontrol S".......................................................................................40
6.3.1 User interface............................................................................................................40
6.3.2 Manual mode.............................................................................................................41
6.3.2.1 Starting a centrifugation run...............................................................................41
6.3.2.2 Interrupting a centrifugation run .........................................................................41
6.3.2.3 Interrupting a deceleration process....................................................................41
6.3.2.4 Selection, display, and modification of data........................................................41
6.3.2.5 Standard menu ..................................................................................................42
6.3.2.6 Process library menu .........................................................................................48
6.3.2.7 Parameters menu ..............................................................................................49
6.3.2.8 Setup menu .......................................................................................................53
6.3.2.9 Curve menu.......................................................................................................56
6.3.2.10 Option: Barcode menu.......................................................................................57
6.3.2.11 Help menu .........................................................................................................59
6.3.2.12 Changing the contrast........................................................................................60
6.3.3 Program mode...........................................................................................................60
6.3.3.1 Saving a program...............................................................................................61
6.3.3.2 Loading a program.............................................................................................61
6.3.3.3 Executing a program..........................................................................................62
6.3.3.4 Deleting a program ............................................................................................62
6.3.3.5 Automatic program rotation................................................................................63
6.3.4 Options for data input and output...............................................................................64
6.3.5 Connection of a separate computer...........................................................................64
6.4 Switching the centrifuge off.............................................................................................64

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7Malfunctions and error correction....................................................................................65
7.1 General malfunctions......................................................................................................65
7.1.1 Emergency lid release...............................................................................................66
7.2 Table of error codes........................................................................................................67
7.3 Service contact...............................................................................................................68
8Maintenance and service................................................................................................... 69
8.1 Maintenance...................................................................................................................69
8.1.1 Centrifuge..................................................................................................................69
8.1.1.1 Condenser (only refrigerated centrifuges with an air-cooled refrigeration system)
..........................................................................................................................70
8.1.2 Accessories...............................................................................................................70
8.1.2.1 Plastic accessories ............................................................................................71
8.1.3 Rotors, buckets and carriers......................................................................................71
8.1.4 Load bearing bolts.....................................................................................................72
8.1.5 Glass breakage .........................................................................................................73
8.2 Sterilisation and disinfection of the rotor chamber and accessories ................................73
8.2.1 Autoclaving................................................................................................................74
8.3 Service ...........................................................................................................................75
8.4 Return of defective centrifuges or parts ..........................................................................76
9Disposal.............................................................................................................................. 78
9.1 Disposal of the centrifuge ...............................................................................................78
9.2 Disposal of the packaging...............................................................................................78
10 Technical data.................................................................................................................... 79
10.1 Ambient conditions .........................................................................................................80
10.2 Technical documentation................................................................................................80
11 Appendix............................................................................................................................ 81
11.1 Range of accessories .....................................................................................................81
11.1.1 Rotor radii..................................................................................................................81
11.2 Speed-gravitational-field-diagram ...................................................................................82
11.3 Acceleration and deceleration curves .............................................................................83
11.4 Table of the service life of rotors and accessories...........................................................85
11.5 Resistance data..............................................................................................................87
11.6 Serial Control Interface Specification..............................................................................91
11.7 EC declaration of conformity.........................................................................................117
12 Index................................................................................................................................. 121

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1 General information
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1 General information
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.
1.2 Further applicable documents
The following documents apply in addition to these operating instructions:
•Transport and installation instructions of the blood bank centrifuge
Sigma 8KBS (part no. 07041)
→
1.3 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 marked with MD is intended for the separation of
blood components that will be used for transfusions. This means that it is a
medical device in the sense of Regulation (EU) 2017/745 on medical
devices.
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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1.4 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.
→
1.5 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.
→
1.6 Standards and regulations
These operating instructions have been created in accordance with the
relevant European standards and regulations (see chapter 11.7 - "EC
declaration of conformity").
→
1.7 Scope of supply
The centrifuge comprises:
Quantity
Components
Possible versions
Part no.
1
floor-standing centrifuge Sigma 8KBS
3 x 400 V, 50 Hz
10635
3 x 220 V, 60 Hz
10636
3 x 400 V, 50 Hz, water cooling
91302
1
swing-out rotor
with windshield and cover
11805
without windshield
11806
6
buckets
13860
min. 6
adapters
adapter for 2 x 750 ml
incl. balance weights
13867
17768
adapter for 2 x 250 ml
incl. balance weights
and clips
13869
17768
17771
adapter for 2 x 500 ml
incl. balance weights
and clips
13870
17768
17770

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The centrifuge comprises:
Quantity
Components
Possible versions
Part no.
1
square spanner, size 8 (door)
930114
1
open spanner, size 10/13 (height
adjustment of the adjustable feet)
930015
1
open spanner, size 24 (lock nuts of the
height adjustment)
930024
1
wrench, angulate, size 17/19 (rotor)
26448
1
tube wrench (emergency release)
930110
1
wrench, hex socket, size 4 (rotor)
930050
1
holder for the rotor cover
with hexagon socket head screw
(M6x16)
(see chapter 5.2 - "Cover holder")
28598
964216
1
hose connector for condensate drain
(installed)
80415
1
tube (30 g) heavy-duty grease for load-
bearing bolts
71401
1
operating manual
incl. EC declaration of conformity
(see chapter 11.7 - "EC declaration of conformity")
07035
Options
Description
Part no.
alternative
serial communication
interface for serial communication RS232 with
option to connect a barcode scanner (without
barcode scanner)
(replaces interface for serial communication
RS232, part no. 71442)
17948
optional
replacement for one adapter 13867
Replacement
incl. balance weight
and balance weight
17769
17753
17754
optional
replacement for one adapter 13870
Replacement
incl. balance weight
and balance weight
17773
17753
17754
optional
adapter for smaller blood bags or for
reduced filling
17750
optional
adapter for platelet bags (short)
17774
optional
adapter for platelet bags (long)
17776

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2 Layout and mode of operation
→
2.1 Layout of the centrifuge
→
2.1.1 Functional and operating elements
1 Lid
2 User interface (see
chapter 6.3.1 - "User
interface")
Fig. 1: Total view of the centrifuge

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3 Locks of the front
door
4 Name plate (see
chapter 2.1.2 -
"Name plate")
Fig. 2: Right side of the centrifuge

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5 Mains power switch
6 Condensate drain
Fig. 3: Left side of the centrifuge
7 Mains cable
8 Option: connector for
barcode scanner
9 RS-232 interface
10 Option: serial
interface
(see chapter 6.3.4 -
"Options for data
input and output")
11 Castor
12 Adjustable foot
Fig. 4: Rear view of an air-cooled centrifuge

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13 Cooling water
connection
Fig. 5: Rear view of a water-cooled centrifuge
→
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 Symbol for special
disposal (see chapter
9 - "Disposal")
10 CE mark in compliance
with the directive
2006/42/EC
11 Marking as per
Regulation (EU)
2017/745 on medical
devices
12 Date of manufacture
13 Consult operating
manual
14 Max. permissible
density
15 Refrigerant data
Fig. 6: Examples of a name plate

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2.2 Mode of operation
→
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.
Das→
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").
→
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 2.1.2 - "Name
plate")
Hot surface
Bucket loading information
(see chapter 6.2.2.2 -
"Installation of accessories")
Attention! General danger
4°C-Garantie
Note concerning the
condensate drain
Name plate (see chapter 6.2.2.2
- "Installation of accessories")
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) 2017/745
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)
NOTE
The symbols 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 (see 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 1.3 - "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.