BANDELIN Sonopuls HD 4050 User manual

Ultrasonic Homogeniser HD 4100
7
Ultrasonic homogenisers
51376g GB/2018-04
User Instructions
Valid for:
HD 4050 Volume: 0.5 ml - 100 ml
HD 4100 Volume: 2 ml - 200 ml
HD 4200 Volume: 5 ml - 1000 ml
HD 4400 Volume: 100 ml - 3000 ml

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1electronic GmbH & Co. KG • Heinrichstraße 3-4 • 12207 Berlin • Deutschland • [email protected]
Copyright & limit of liability
This document may not be reproduced, either in full or in extracts, without prior approval of BANDELIN electronic GmbH & Co. KG,
hereinafter referred to as BANDELIN.
The German original is the binding version of this document. Any differences in the translation are not binding and have no
legal effect. In case of any discrepancies between the translation and the original of this document, the original version will take
precedence.
BANDELIN accepts no responsibility or liability for damages caused by improper handling or usage contrary to the intended
purpose.
The documentation was prepared with great care. Liability for indirect or direct damages arising because of incomplete or
erroneous information in this documentation, as well as in its delivery and usage, is excluded.
© 2018
1 2 GmbH & Co. KG, Heinrichstrasse 3 – 4, Germany, 12207 Berlin,
Phone: [phone] - 0, Fax: [phone], [email protected]

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1electronic GmbH & Co. KG • Heinrichstraße 3-4 • 12207 Berlin • Deutschland • [email protected]
General
The equipment, the accessories and the preparations are to be used in accordance with the user
instructions and/or the product information.
The instructions are part of the scope of delivery and should be stored in the vicinity of the
device for later reference. This also applies if possession of the device is transferred elsewhere.
Before the device is put into operation, these Instructions for Use should be read carefully and
completely in order for the user to become familiarised with all functions.
The warnings and safety precautions (chapter 1.5) must always be heeded during use.
The manufacturer will not assume any responsibility for the device's safety or functional ability
in the event of improper handling or usage contrary to the intended purpose. In the event of
unauthorised alterations/modifications, both the warranty claim and the CE conformity will no
longer be valid.
If Service is required, please contact the specialist dealer in charge or the manufacturer.
Symbols used:
Symbol Significance Explanation
Danger Identifies information that could signify a risk to life and limb,
especially through electric shock, if not observed.
Caution
Identifies information that is to be observed and adhered to
without fail in order to prevent damage to the device and the
user.
When device parts are labelled with this symbol, reference
must be made to the documentation.
Warning Warning of hot surface.
Important Identifies information that is important for execution.
Note Identifies information provided for explanatory purposes.
In vitro diagnostics
information
Identifies information that is important for in vitro diagnostics
applications.
Medical note Identifies information that is important for medical use.
Do not grip inside For health reasons, touching the oscillating fluid is prohibited.
Wear ear protectors For health reasons, standing for long periods of time in the
vicinity of the device without ear protectors is prohibited.
Handling instructions Identifies instructions that must be followed in the described
sequence.

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1electronic GmbH & Co. KG • Heinrichstraße 3-4 • 12207 Berlin • Deutschland • [email protected]
Table of Contents
1 Product description .........................................................................................................6
1.1 Mode of operation ..........................................................................................................7
1.2 Purpose ..........................................................................................................................7
1.3 CE conformity .................................................................................................................7
1.4 Technical data ................................................................................................................8
1.4.1 HF Generator (GM) ........................................................................................................8
1.4.2 Degree of protections .....................................................................................................9
1.4.3 Technical data, ultrasonic transducers .........................................................................10
1.4.4 Electromagnetic ambient conditions (EMC) .................................................................10
1.4.5 Remote operation .........................................................................................................10
1.5 Warnings and safety precautions .................................................................................12
2 Preparation ...................................................................................................................14
2.1 Scope of delivery ..........................................................................................................14
2.2 Set-up / assembly .........................................................................................................14
2.3 Start-up .........................................................................................................................15
3 Operation ......................................................................................................................15
3.1 Operating elements ......................................................................................................15
3.1.1 Turning the homogeniser on/off .................................................................................... 16
3.1.2 Explanation of the display fields ...................................................................................16
3.2 Setting the operating parameters .................................................................................16
3.2.1 Sonication time [Time set] ............................................................................................17
3.2.2 Pulsation [Pulsation] .....................................................................................................18
3.2.3 Temperature monitoring [Temperature] ........................................................................19
3.2.4 Miscellaneous functions and settings ...........................................................................20
3.3 Loading / saving sonication programmes .....................................................................21
3.4 Batch operation (batch processing) ..............................................................................22
3.5 Activating / deactivating the ultrasound ........................................................................23
4 Use ...............................................................................................................................24
4.1 Instructions for use .......................................................................................................24
4.2 General use ..................................................................................................................24
4.3 Selecting a suitable probe ............................................................................................26
4.3.1 Mounting and dismounting of the probes .....................................................................27
4.3.1.1 Mounting and dismounting the titanium plates .............................................................28

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4.3.1.2 Mounting and dismounting of titanium probes ..............................................................29
4.4 Dismounting and mounting the standard horns ............................................................30
5 Cleaning and maintenance of the homogeniser ...........................................................32
5.1 Cleaning and care ........................................................................................................32
5.2 Treatment of contaminated parts in the ultrasonic transducer, vessels and accessories
pertaining to the medical field .......................................................................................33
5.3 Warehousing / storage ................................................................................................. 33
6 Maintenance and repair ................................................................................................34
6.1 Maintenance .................................................................................................................34
6.2 Functional checks .........................................................................................................34
6.2.1 Testing the ultrasonic transducer (probe check) – Error 011 ........................................ 34
6.2.2 Conducting a frequency scan (scan frequency) – Error 002/011/012 ..........................34
6.3 Error analysis ...............................................................................................................36
6.4 Repairs and service ......................................................................................................39
6.4.1 Decontamination certificate ..........................................................................................39
6.4.2 Software version display ..............................................................................................39
7 Accessories ..................................................................................................................40
7.1 Required accessories ...................................................................................................40
7.2 Optional accessories ....................................................................................................40
7.3 Preparations - not applicable - .................................................................................... 41
8 Consumable materials - not applicable - .....................................................................41
9 Taking the unit out of service ........................................................................................41
10 Key words .....................................................................................................................41
Informative appendices
A Spanner for mounting/dismounting
B Decontamination - sample copy

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4a
5
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1electronic GmbH & Co. KG • Heinrichstraße 3-4 • 12207 Berlin • Deutschland • [email protected]
1 Product description
The SONOPULS ultrasonic homogeniser is essentially made up of three components: the HF
generator, the ultrasonic transducer, and the working tip (probe). The individual components can
be varied using a multitude of options and accessories. The type specification and serial number
are found on the type plate.
Product features:
• HF generator (1) in low-maintenance, robust plastic housing, with connections for the ultrasonic
transducer, the temperature sensor (2), and the recessed handle.
• Operating and display panel (2) with LC display (3)
• Ultrasonic transducer (4) with Start/Stop button (4a)
• Ultrasonic oscillating system (5)
• Standard horn (6) not included with UW 50
• Probe (7)
• Mains switch (8)
• HF connection (9) or ultrasonic converter - MINISNAP
• Connection for temperature sensor (10)
Rear side of the HF generator:
• Mains socket (11) with fuse holder
• Remote control connector(12)
• RS 232 interface (13)

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1electronic GmbH & Co. KG • Heinrichstraße 3-4 • 12207 Berlin • Deutschland • [email protected]
1.1 Mode of operation
The HF generator transforms the absorbed mains energy (mains frequency 50 or 60 Hz) into
high-frequency energy with a frequency of 20 kHz. Thanks to the ultrasonic transducer that is
connected to the HF generator, the high-frequency energy of the HF generator is converted into
ultrasound and thus into mechanical energy. This takes place with an efficient and robust PZT
ultrasonic oscillating system. Thus, mechanical deflections with a similar frequency of 20 kHZ,
which are transferred into the sonication medium as ultrasound waves with a high power intensity,
are generated on the tip of the probe. The amplitude is held constant by the ultrasonic transducer
(AMPLICHRON®system), independently from the applied load, using a signal feedback as long as
the maximum power allowed is not exceeded. Thanks to these measures, the reproducibility of the
process parameters is guaranteed and validation of the process is supported.
Standard horns with probes (micro tips, tapered tips or titanium plates) are mounted on the
ultrasonic transducer. These work as mechanical transformers and enable a multiple mechanical
amplification of the ultrasound amplitude at the tip.
1.2 Purpose
SONOPULS ultrasonic homogenisers generate high-performance ultrasound with high intensities
and ultrasonic amplitudes, which are transferred into liquid media using working tools called
probes. They are used in laboratories, clinics, and in industrial research, and they perform diverse
tasks during sample preparation in Quality Assurance, scientific experiments, analyses, and in
pilot or short-series manufacture.
Application examples:
• Cell disruption for paternity tests
• Cell disruption (extraction of microorganisms, tissue cells)
• Homogenising of liquids
• Emulsifying hard-to-mix liquids
• Dispersion of agglomerates
• Acceleration of chemical reactions
• Degassing of fluids
• Sample preparation in environmental analytics (wastewater tests, soil samples)
• Sonochemistry
1.3 CE conformity
SONOPULS ultrasonic homogenisers are declared as IVD products and satisfy the CE marking
criteria for the European Directives:
- IVD directive
- Low-voltage directive
- Electromagnetic compatibility directive
in their currently valid versions.
A declaration of conformity can be requested from the manufacturer by providing the serial
number.

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1electronic GmbH & Co. KG • Heinrichstraße 3-4 • 12207 Berlin • Deutschland • [email protected]
1.4 Technical data
SONOPULS ultrasonic homogenisers are interference-free and marked with a CE -.
Safety: EN 61010-1,
EMC: EN 61326-1
1.4.1 HF Generator (GM)
Mains connection: 230 V~ (± 10 %) 50/60 Hz, alternatively 115 V~ (± 10 %)
50/60 Hz, cable length 2 m
Protection class: I
Ultrasound frequency: 20 kHz ± 500 Hz
Frequency control/1: Automatic, resonance frequency search
Time setting range: 0:00:01 – 9:59:59 [h:mm:ss] or continuous operation
Ultrasound operating mode: Pulsating or continuous
Pulsation time ON (tE): 0.2 - 600 s - (see chapter 3.2.2)
Pulsation time OFF (tA): 0.3 - 600 s - (see chapter 3.2.2)
Ultrasound control: Amplitude or power - (see chapter 3.2.4)
Amplitude setting range: 10 - 100 % in 1 % steps
Amplitude display / power display: Presetting and progress bars
Energy display: kJ
Temperature sensor: optional (TM 50 or TM 100)
Temperature display: -10 – 120 °C
Programme storage locations: 9
Operating elements: Membrane key
Operating data display: LCD graphic display, illuminated
Remote control (turning on/off): Button on the ultrasonic transducer, potential-free contact,
foot switch TS 8 (optional)
Interface: RS 232
Degree of protection: IP 30 according to DIN EN 60529
Device-specific:
Generator GM 4100 GM 4200 GM 4400
HF power/2, maximum 50/100 W/3 50/200 W3 200/400 W3
HF frequency 20 kHz
Power setting range 15 – 75 W 30 - 150 W 60 - 300 W
Weight (approx.) 3 kg 3.2 kg 3.6 kg
Dimensions (l × w × h) 335 × 150 × 230 mm
/1 Frequency control:
The HF generator has an automatic search feature for resonance frequency and rate adaptation while in operation. Causes for a change
in the resonance frequency are, for example, a warming of the ultrasonic transducer and the probes, a change in the acoustic load due to
changes in viscosity, and even the mounting of another probe. A frequency drift during operation is corrected by the automatic frequency
control. The optimum working frequency is sought using the resonance frequency search, e.g. after a change in probe.
/2 HF power:
In the case of amplitude control, the ultrasonic power that is needed for the desired probe amplitude is dependent on the viscosity of the
medium. In order to prevent damage to the HF generator and converter, the power is limited to the maximum-allowed peak value. In the
case of highly viscous media, this can also result in the desired amplitude not always being reached.
/3 depending on the connected ultrasonic transducer

Protected against access to hazardous parts
with tools; protected against solid objects with
a diameter of 2.5 mm or larger
Not protected
Protected against access to dangerous parts
with fingers Protected against solid foreign
bodies with a diameter of 12 mm or larger
Not protected
IP 20 according to DIN EN 60529
IP 30 according to DIN EN 60529
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1electronic GmbH & Co. KG • Heinrichstraße 3-4 • 12207 Berlin • Deutschland • [email protected]
Environmental conditions pursuant to EN 61 010-1
Overvoltage category: II
Degree of contamination: 2
Permissible relative humidity up to 31 °C: 80 %
Permissible relative humidity up to 40 °C: 50 %
Permissible ambient temperature: 5 to 40 °C
Altitude: up to 2000 m
No condensation allowed.
Only for indoor operation.
Specifications for use as a medical device
Name: Ultrasonic homogeniser
UMDNS nomenclature (ECRI / DIMDI): 17-125
Purpose: see chapter 1.2
Medical device pursuant to
Directive 98/79/EC for in-vitro diagnostic medical devices: Category 5 device (miscellaneous)
Type, model, serial number, year of manufacture: See type plate on the generator for information
The homogeniser has been inspected pursuant to norms currently in effect and must be installed
and put into operation pursuant to EMC directions; information in this regard is found in the
appendix.
Specifications pursuant to the Medical Devices Operator Ordinance (MPBetreibV):
Start-up on location, functional check
and personnel training (section 5): not required
Technical safety controls, (STK, section 6): no specifications
Technical measurement controls, (MTK, section 11): not applicable
e-procurement
e-cl@ss:
HD device classification: 32-08-02-02
HD accessories classification: 32-08-92-05
1.4.2 Degree of protections

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1.4.3 Technical data, ultrasonic transducers
UW 50 UW 100 UW 200 UW 400
PZT ultrasonic
oscillating system: 
Start/Stop key: 
Suitable for
continuous
operation:

Frequency: 20 kHz 20 kHz 20 kHz 20 kHz
Weight: 0.6 kg 1.5 kg 1.6 kg 1.7 kg
Dimensions: dia. 50 × 190 mm dia. 70 × 170 mm dia. 70 × 170 mm dia. 90 × 180 mm
Degree of
protection: IP 20 IP 20 IP 20 IP 20
For environmental conditions, see chapter 1.4.
1.4.4 Electromagnetic ambient conditions (EMC)
The device was tested to DIN EN 61326-1 for electromagnetic compatibility (EMC) and complies
with the requirements for class B devices according to EN 55011.
It is suitable for use in facilities and areas which are directly connected to a public low-voltage
supply network, e.g. medical laboratory facilities.
1.4.5 Remote operation
Several options are available for remote control and remote operation. Depending on
requirements, the most convenient solution may be selected.
Operating
element Methods Functions Connection
1Key manual Ultrasound operation ON/OFF Fixed on the ultrasonic
transducer
2Foot switch foot-operated Ultrasound operation ON/OFF Remote control
connector
3 External control signal • Ultrasound operation ON/OFF
• Status confirmation
Remote control
connector
4 External data protocol • Status inquiry
• Full device control
RS 232 interface