Hettich ROTANTA 460 User manual

ROTANTA 460 / 460 R / 460 RC / 460 RF
Rev.: 05 / 11.2023AB5650en_SA
Inhalt des Dokuments / content of the document
Operating instructions (EN)
Rotoren und Zubehör / Rotors and accessories

AB5650en_SARev.: 05 / 11.2023

Translation of the original operating instructions
ROTANTA 460 / 460 R / 460 RC / 460 RF
Operating instructions
1 / 73
Rev.: 05 / 11.2023
AB5650en_SA

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Andreas Hettich GmbH & Co.KG
Föhrenstrasse 12
D-78532 Tuttlingen, Germany
Telephone: [phone]
Fax: [phone]
Email: [email protected], [email protected]
Internet: www.hettichlab.com
©2023 – All rights reserved

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Table of contents
Table of contents
1 About this document. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.1 Use of this document. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.2 Gender reference. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.3 Symbols and labels in this document. . . . . . . . . . . . . . . . . . . . . 6
2 Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.1 Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.2 Personnel requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.3 Operator's responsibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
2.4 Safety instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3 Device overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
3.1 Technical data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
3.2 European registration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
3.3 Important labels on the packaging. . . . . . . . . . . . . . . . . . . . . . . 16
3.4 Important labels on the device. . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.5 Operating and indicator elements. . . . . . . . . . . . . . . . . . . . . . . 18
3.5.1 Control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
3.5.2 Indicator elements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
3.5.3 Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
3.6 Original spare parts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.7 Scope of supply. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.8 Returns. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4 Transport and storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
4.1 Transport and storage conditions. . . . . . . . . . . . . . . . . . . . . . . 22
4.2 Fastening the transport lock. . . . . . . . . . . . . . . . . . . . . . . . . . . 22
5 Commissioning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
5.1 Unpacking the centrifuge. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
5.2 Remove the transport lock. . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
5.3 Setting up and connecting the centrifuge. . . . . . . . . . . . . . . . . 29
5.4 Switching the centrifuge on and off.. . . . . . . . . . . . . . . . . . . . . . 31
6 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
6.1 Opening and closing the lid. . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
6.2 Removing and installing the rotor. . . . . . . . . . . . . . . . . . . . . . . . 32
6.3 Inserting and removing buckets. . . . . . . . . . . . . . . . . . . . . . . . . 33
6.4 Inserting and removing adapters. . . . . . . . . . . . . . . . . . . . . . . . 34
6.5 Loading. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
6.6 Opening and closing the biosafety system. . . . . . . . . . . . . . . . . 36
6.6.1 Explanation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
6.6.2 Lid with screw cap and hole . . . . . . . . . . . . . . . . . . . . . . . 37
6.6.3 Lid with bracket and spring-type lock. . . . . . . . . . . . . . . . . 37
6.6.4 Lid with screw cap. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
6.6.5 Lid with spring-type lock . . . . . . . . . . . . . . . . . . . . . . . . . . 38
6.7 Packing instructions, HettLiner. . . . . . . . . . . . . . . . . . . . . . . . . 38

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Table of contents
6.8 Centrifugation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
6.8.1 Centrifugation in continuous operation. . . . . . . . . . . . . . . . 40
6.8.2 Centrifugation with time preselection. . . . . . . . . . . . . . . . . 41
6.8.3 Short-term centrifugation. . . . . . . . . . . . . . . . . . . . . . . . . . 41
6.8.4 Changing settings during centrifugation. . . . . . . . . . . . . . . 42
6.9 Quick stop function. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
7 Software operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
7.1 Centrifugation parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
7.1.1 Ramp-up and ramp-down parameters. . . . . . . . . . . . . . . . 42
7.1.2 Runtime TIME. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
7.1.3 Speed, RPM. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
7.1.4 Integral RCF. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
7.1.5 Temperature (for centrifuges with cooling). . . . . . . . . . . . . . 45
7.1.6 Relative centrifugal force, RCF. . . . . . . . . . . . . . . . . . . . . . 45
7.1.7 Relative centrifugal force RCF and centrifuging radius RAD 46
7.1.8 Centrifugation of substances or mixtures of substances
with a density higher than 1.2 kg/dm3. . . . . . . . . . . . . . . . 46
7.2 Programming. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
7.2.1 Write protection for programs. . . . . . . . . . . . . . . . . . . . . . . 47
7.2.2 Opening or loading programs. . . . . . . . . . . . . . . . . . . . . . . 47
7.2.3 Entering or changing programs. . . . . . . . . . . . . . . . . . . . . 47
7.2.4 Automatic buffer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
7.3 Rotor detection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
7.4 Cooling (for centrifuges with cooling). . . . . . . . . . . . . . . . . . . . . 48
7.4.1 Instructions, cooling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
7.4.2 Standby cooling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
7.4.3 Precooling the rotor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
7.4.4 Delayed cooling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
7.4.5 Preventing cooling from switching on during ramp-down. . 49
7.4.6 Temperature monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . 50
7.5 Heating (for centrifuges with heating). . . . . . . . . . . . . . . . . . . . . 50
7.6 Machine Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
7.6.1 Querying system information. . . . . . . . . . . . . . . . . . . . . . . 51
7.6.1.1 Centrifuge address. . . . . . . . . . . . . . . . . . . . . . . . . . . 52
7.6.2 Cycle counter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
7.6.3 Querying operating hours, centrifugation runs and cycle
counter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
7.6.4 Enabling or disabling dual time mode. . . . . . . . . . . . . . . . . 55
7.6.5 Enabling or disabling B-brake levels. . . . . . . . . . . . . . . . . . 56
7.6.6 Enabling or disabling ramp-up and ramp-down times. . . . . 56
7.6.7 Program lock. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
7.6.8 PIN (Personal Identication Number). . . . . . . . . . . . . . . . . . 57

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Table of contents
7.6.9 Audible signal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
7.6.9.1 General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
7.6.9.2 Enabling or disabling an audible signal. . . . . . . . . . . . 59
7.6.10 Centrifugation data displayed after switching on. . . . . . . . . 59
7.6.11 Setting a temperature unit (for centrifuges with cooling). . . 60
7.6.12 Indicator backlight. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
7.7 Program links. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
7.7.1 Linking programs or changing a program link. . . . . . . . . . . 61
7.7.2 Opening a program link. . . . . . . . . . . . . . . . . . . . . . . . . . . 62
7.7.3 Enabling or disabling program links. . . . . . . . . . . . . . . . . . 62
8 Cleaning and care. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
8.1 Overview table. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
8.2 Cleaning and disinfection instructions. . . . . . . . . . . . . . . . . . . . 63
8.3 Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
8.4 Disinfection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
8.5 Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
9Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
9.1 Fault description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
9.2 Perform a MAINS RESET. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
9.3 Emergency release. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
9.4 Switching on the automatic circuit breaker . . . . . . . . . . . . . . . . 69
10 Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
10.1 General instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
11 Index. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

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Safety
General symbols
Intended use
1 About this document
1.1 Use of this document
■Read this document carefully and in full before commissioning the
device for the rst time.
Observe other enclosed instruction sheets where necessary.
■This document is part of the device and must be kept within easy reach.
■This document must be included if the device is passed on to a third
party.
■The current version of the document in the available languages can be
found on the manufacturer's website: ⮫ https://www.hettichlab.com/de/
download-center/
1.2 Gender reference
The employed masculine or feminine language form is to facilitate reading.
In the spirit of equal treatment, corresponding terms apply in principle to all
genders and do not imply any valuation.
1.3 Symbols and labels in this document
The following markers are used in this document to highlight instructions,
results, listings, references and other elements:
Marker Explanation
1.
2.
3.
...
Step-by-step instructions
áResults of action steps
æReferences to sections of the document and
other applicable documents
■...
■...
Listings without a xed order
[Buttons] Controls (for example: buttons, switches)
‘Indicator’ Indicator elements (for example: signal lights,
screen elements)
2Safety
2.1 Intended use
This device is a laboratory centrifuge suitable for medical applications.
Their exclusive therapeutic purpose is to centrifuge blood in blood bag sys-
tems. The separated blood components are transferred by another device
(separator) into corresponding satellite bags. The individual components
obtained in this way are then used for transfusion or autotransfusion.
The centrifuge is only to be operated by qualied personnel working for
blood donation services or hospitals.
The centrifuge is only intended for the uses referred to above.

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Safety
Non-intended use
Foreseeable misuse
Required qualifications
The user is trained in laboratory practice and able to carry out the work
assigned to them, and to recognise and prevent potential hazards inde-
pendently.
Personal protective equipment
Any other use or use beyond this is considered improper. Andreas Hettich
GmbH & Co. KG shall not be liable for any damage arising from this.
Intended use also includes the observation of all instructions in the user
manual and compliance with the required inspection and maintenance inter-
vals.
■The centrifuge is not suitable for use in explosive or radioactive, or
biologically or chemically-contaminated atmospheres.
■The user must take appropriate actions when centrifuging hazardous
substances or mixtures of substances that are toxic, radioactive or con-
taminated with pathogenic microorganisms.
The manufacturer generally recommends using only centrifuge tubes
with special screw caps for hazardous substances.
Use sealable centrifuge tubes with a biosafety system for materials of
risk groups 3 and 4.
■The manufacturer does not recommend centrifugation with ammable or
explosive materials.
■The manufacturer does not recommend centrifugation with materials
that react chemically with one another with high energy.
The manufacturer recommends using only accessories that it has approved
for the intended purpose.
Only operate the centrifuge under supervision.
2.2 Personnel requirements
The user has read the user manual in full and familiarised themselves with
the device.
NOTICE
Damage to the device by unauthorised personnel
−Tampering with and modications to devices by unau-
thorised persons are at the operating organisation's own
risk and will result in the loss of all warranty and liability
claims.
Trained user
Lack of personal protective equipment or unsuitable personal protective
equipment increases the risk of impaired health and injury.
■Only use personal protective equipment that is in proper condition.
■Only use personal protective equipment that is adapted to the person
(correct size, for example).
■Observe instructions on other protective equipment for specic activities.

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Safety
Provide information
Training of personnel
2.3 Operator's responsibility
Follow the instructions in this document for proper and safe
use of the device.
Keep the user manual for future reference.
■Following the instructions in this document will help:
–To avoid dangerous situations.
–To minimise repair costs and downtime.
–To increase the reliability and service life of the device.
■The operator is responsible for compliance with company regulations,
standards and national laws.
■Note and keep the revision of the document separate from the docu-
ment. If lost, the document can be replaced in the correct revision.
■Keep the user manual available at the place where the device is used.
■Pass the user manual on to the buyer when the device is sold.
Lack of knowledge when working with the device may result in serious
injury or death.
■Instruct personnel on their tasks and the associated risks in accordance
with the instruction.
2.4 Safety instructions
Reporting serious incidents and notiable incidents
In the event of serious incidents or notiable incidents
involving the device or its accessories, these must be
reported to the manufacturer and, where applicable, to the
competent authority where the user and/or the patient is
registered.
DANGER
Risk of contamination for the user due to inadequate
cleaning or failure to observe the cleaning instructions.
−Observe cleaning instructions.
−Wear personal protective equipment when cleaning the
device.
−Observe laboratory regulations (e.g. TRBAs, the German
Protection against Infection Act, hygiene plan) for han-
dling biological agents.
DANGER
Fire and explosion hazard due to hazardous substances in
samples.
−Observe relevant regulations and directives for handling
chemicals and hazardous substances.
−Do not use aggressive chemicals (for example: dan-
gerous, corrosive extraction agents such as chloroform,
strong acids).

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Safety
WARNING
Dangers due to insufcient maintenance or maintenance not
carried out on time.
−Follow maintenance intervals.
−Check the device for visible damage or defects.
If any visible damage or defects are present, take the
device out of service and inform a service technician.
WARNING
Risk of electric shock due to ingress of water or other liq-
uids.
−Protect the device against external liquids.
−Do not pour any liquids into the interior of the device.
−Transport using original transport packaging.
WARNING
Contamination with hazardous substances and substance
mixtures!
Observe the following actions for substances and substance
mixtures that are toxic, radioactive and/or contaminated with
pathogenic microorganisms:
−As a rule, use only centrifuge tubes with special screw
caps for hazardous substances.
−Use sealable centrifuge tubes with a biosafety system
for materials of risk groups 3 and 4.
−If no biosafety system is used, the device is not micro-
biologically tight in the sense of standard EN / IEC
61010-2-020.
−Contact the manufacturer if necessary.
WARNING
Risk of injury and damage to the device due to a loose rotor.
−The driver of the rotor shaft must be correctly seated in
the groove of the rotor when mounting the rotor.
−Hand-tighten the nut securing the rotor.
−Check that the rotor is rmly seated.
−Follow maintenance intervals.
CAUTION
Risk of injury due to rotating rotor
Long hair and items of clothing can get caught on the rotor if
the rotor is moved manually.
−Tie long hair back.
−Do not allow garments to hang in the centrifuging
chamber.

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Device overview
NOTICE
Damage to the device electronics due to incorrect voltage or
frequency at the device circuit breaker.
−Operate the device with the correct mains voltage and
mains frequency.
The value can be found in the technical data and on the
rating plate.
NOTICE
Damage to the device and samples due to premature pro-
gram termination.
Premature program termination is caused by power failure,
switching off during the program or pulling out the mains
plug.
−Do not switch off the device while the program is run-
ning.
−Do not trigger the emergency release on the device
while the program is running.
−Do not pull out the mains plug while the program is
running.
3Device overview
3.1 Technical data
Manufacturer Andreas Hettich GmbH & Co.KG,
D-78532 Tuttlingen
Model ROTANTA 460
Type 5650 5650-01
Mains voltage (±10%) 200-240V1～100-127V1～
Mains frequency 50-60 Hz 50-60 Hz
power consumption 1000 VA 1100 VA
Power consumption 5.0A 11.0A
max. capacity 4 x 1000 ml
max. permissible density 1.2kg/dm³
max. speed (RPM) 15000
max. acceleration (RCF) 24400
max. kinetic energy 41000 Nm
Obligation to perform
checks
(DGUV Rules 100-500)
(valid only in Germany)
yes

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Device overview
Ambient conditions (EN / IEC 61010-1):
Installation 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,
decreasing linearly to 50%relative humidity at 40°C.
Overvoltage category
(IEC 60364-4-443)
II
Pollution level 2
Device protection class I
not suitable for use in potentially explosive atmospheres.
EMC:
Emitted EM interference,
EM interference immunity
EN/IEC61326-1
Class B
FCC Class B
Noise level
(rotor-dependent)
£68dB(A)
Dimensions:
Width 554 mm
Depth 706 mm 715 mm
Altitude 456 mm
Weight approx.101kg approx.111kg
Manufacturer Andreas Hettich GmbH & Co.KG,
D-78532 Tuttlingen
Model ROTANTA 460 R
Type 5660
5660-50
5660-20
5660-70
5660-07 5660-77
Mains voltage (±10%) 200-240V1～200-240V1～
Mains frequency 50 Hz 60 Hz
power consumption 1800 VA 1900 VA
Power consumption 8.5A 9.2A
Refrigerant R452A
max. capacity 4 x 1000 ml
max. permissible density 1.2kg/dm³

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Device overview
max. speed (RPM) 15000
max. acceleration (RCF) 24400
max. kinetic energy 51000 Nm
Obligation to perform
checks
(DGUV Rules 100-500)
(valid only in Germany)
yes
Ambient conditions (EN / IEC 61010-1):
Installation 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,
decreasing linearly to 50%relative humidity at 40°C.
Overvoltage category
(IEC 60364-4-443)
II
Pollution level 2
Device protection class I
not suitable for use in potentially explosive atmospheres.
EMC:
Emitted EM interference,
EM interference immunity
EN/IEC61326-1
Class B
Noise level
(rotor-dependent)
£66dB(A)
Dimensions:
Width 770 mm
Depth 706 mm 723 mm 706 mm 723 mm
Altitude 456 mm 481 mm 456 mm 481 mm
Weight approx.141kg
Manufacturer Andreas Hettich GmbH & Co.KG,
D-78532 Tuttlingen
Model ROTANTA 460 R ROTANTA 460 RC
Type 5660-01
5660-51
5670
5670-50
Mains voltage (±10%) 100-127V1～100V1～200-240V1～

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Device overview
Mains frequency 50 Hz 50 Hz 50 Hz
power consumption max. 2000VA 1800 VA
Power consumption - 8.5A
Refrigerant R452A
max. capacity 4 x 1000 ml
max. permissible density 1.2kg/dm³
max. speed (RPM) 15000
max. acceleration (RCF) 24400
max. kinetic energy 51000 Nm
Obligation to perform
checks
(DGUV Rules 100-500)
(valid only in Germany)
yes
Ambient conditions (EN / IEC 61010-1):
Installation 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,
decreasing linearly to 50%relative humidity at 40°C.
Overvoltage category
(IEC 60364-4-443)
II
Pollution level 2
Device protection class I
not suitable for use in potentially explosive atmospheres.
EMC:
Emitted EM interference,
EM interference immunity
FCC Class B EN/IEC61326-1
Class B
Noise level
(rotor-dependent)
£66dB(A) £68dB(A)
Dimensions:
Width 7700 mm 554 mm
Depth 715 mm 697 mm

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Device overview
Altitude 456 mm 683 mm
Weight approx.151kg approx.140kg
Manufacturer Andreas Hettich GmbH & Co.KG,
D-78532 Tuttlingen
Model ROTANTA 460 RF
Type 5675
5675-50
5675-01
5675-51
Mains voltage (±10%) 200-240V1～100-127V1～100V1～
Mains frequency 50 Hz 60 Hz 50 Hz
power consumption 1800 VA max. 2000VA
Power consumption 8.5A
Refrigerant R452A
max. capacity 4 x 1000 ml
max. permissible density 1.2kg/dm³
max. speed (RPM) 15000
max. acceleration (RCF) 24400
max. kinetic energy 51000 Nm
Obligation to perform
checks
(DGUV Rules 100-500)
(valid only in Germany)
yes
Ambient conditions (EN / IEC 61010-1):
Installation 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,
decreasing linearly to 50%relative humidity at 40°C.
Overvoltage category
(IEC 60364-4-443)
II
Pollution level 2
Device protection class I
not suitable for use in potentially explosive atmospheres.
EMC:

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AB5650en_SA
Device overview
Rating plate
Emitted EM interference,
EM interference immunity
EN/IEC61326-1
Class B
FCC Class B
Noise level
(rotor-dependent)
£68dB(A)
Dimensions:
Width 554 mm
Depth 697 mm
Altitude 961mm
Weight approx.164kg approx.174kg
23
10
11
17
12
13
15
14
16
1819
24
20
22
21
2 43 5 6 7 8 91
Fig. 1: Rating plate
1 Item number
2 Serial number
3 Revision
4 Equipment number
5 Data matrix code
6 any labelling indicating whether medical device or in vitro diagnostic
medical device
7 Global Trade Item Number (GTIN)
8 Date of manufacture
9 Serial number
10 any EAC mark, CE mark
11 Country of manufacture
12 Date of manufacture
13 Mains frequency
14 Maximum kinetic energy
15 Maximum permissible density
16 Manufacturer's address
17 any Coolant circuit pressure
18 any Coolant capacity
19 any Coolant type
20 Revs per minute
21 Performance values
22 Mains voltage

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Device overview
Device conformity
Single Registration Number
Basic-UDI-DI
23 any Device designation
24 Manufacturer's logo
3.2 European registration
Device conformity according to EU directives.
Notied body:
mdc medical device certication GmbH – Notied Body CE 0483
Tel: [phone]
Fax: [phone]
E-mail: [email protected]
Website: www.mdc-ce.de
Address: Kriegerstrasse 6, D-70191 Stuttgart, Germany
SRN: DE-MF-000010680
Basic-UDI-DI Device assignment
040506740100039N ROTANTA 460 / 460R / 460RC / 460RF
(medical device)
3.3 Important labels on the packaging
TOP
This is the correct upright position of the shipping container for transport and/or storage.
FRAGILE GOODS
The contents of the shipping container are fragile, so it must be handled with care.
PROTECT FROM MOISTURE
The shipping container must be kept away from rain and kept in dry conditions.
TEMPERATURE LIMITATION
The shipping container must be stored, transported and handled within the indicated temperature
range (-20°Cto+60°C).

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Device overview
HUMIDITY LIMITATION
The shipping container must be stored, transported and handled within the indicated air humidity
range (10%to80%).
STACK LIMITATION BASED ON QUANTITY
Maximum number of identical packages that may be stacked on the lowest package, "n" standing
for the number of packages allowed. The lowest package is not included in "n".
3.4 Important labels on the device
The labels on the device must not be removed or covered,
or have anything pasted over them.
Attention, general danger area.
Ensure you read the instructions for commissioning and operation and observe the safety instruc-
tions before using the device.
Biohazard warning.
Warning: hot surface.
Failure to observe this warning may result in damage to property and/or personal injury.
Direction of rotation of the rotor.
The orientation of the arrow indicates the rotor's direction of rotation.
Symbol for the separate collection of electrical and electronic equipment, in accordance with
Directive 2012/19/EU (WEEE).
Use in European Union countries, Norway and Switzerland.
The centrifuge is equipped with an RS232 interface.
The RS232 interface is marked with a symbol.
The centrifuge can be controlled and data retrieved via the interface. The [PROG] button lights up
during data communication.

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Device overview
Fig. 4: [Cooling] button
Fig. 5: [PROG] button
Fig. 6: [RCF] button
Equipotential: Connector (PE plug) for equipotential bonding (only for centrifuges with a PE plug).
Automatic circuit breaker
3.5 Operating and indicator elements
3.5.1 Control
Fig. 2: Control (device with cooling)
Fig. 3: Control (device without cooling)
3.5.2 Indicator elements
■The button ashes until the rotor is read in.
■The button lights up during the centrifugation run to pre-cool the rotor
for as long as the rotor is not yet at a standstill.
■The button lights up when data communication is taking place.
■The button lights up when the RCF is displayed.