BANDELIN Sonoplus HD 2070 User manual

Ultrasonic Homogeniser HD 2070
7Ultrasonic Homogenisers
Instructions for Use
valid for:
HD 2070 Volume: 1 ml - 500 ml
HD 2200 Volume: 2 ml - 1000 ml
51436a GB/2017-10

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-language 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 damage caused by improper handling or usage contrary to the intended
purpose.
The documentation has been prepared with great care. Liability for indirect or direct damage arising because of incomplete or
erroneous information in this documentation, as well as its delivery and usage, is excluded.
© 2017
1 2 GmbH & Co. KG, Heinrichstrasse 3 – 4, Germany, 12207 Berlin,
Tel.: [phone] - 0, Fax: [phone], [email protected]
2 / 44 51436a GB/2017-10
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 are to be read carefully and completely
in order for the user to become familiarised with all functions.
The warnings and safety precautions (chapter 1.5) are always to 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 must be observed and adhered to
without fail in order to avoid damage to the device and user.
When device parts are labelled with this symbol, the
documentation must be referred to.
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, spending long periods of time in the
vicinity of the device without ear protectors is prohibited.
Operating sequence
instructions
Identifies instructions that must be followed in the described
sequence.
3 / 4451436a GB/2017-10
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 .................................................................................................................8
1.4 Technical data ................................................................................................................ 8
1.4.1 HF Generator (GM) ........................................................................................................8
1.4.2 Technical data, ultrasonic transducers (UW) ................................................................ 10
1.4.3 Remote operation ......................................................................................................... 11
1.4.4 Electromagnetic ambient conditions (EMC) ................................................................. 11
1.5 Warning and safety precautions ...................................................................................12
2 Preparation ...................................................................................................................13
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 Types of operation ........................................................................................................ 16
3.1.2 Power - Amplitude setting ............................................................................................. 16
3.1.3 Advantages of the generator ........................................................................................ 16
4 Use ...............................................................................................................................17
4.1 Notes on use ................................................................................................................17
4.2 General use ..................................................................................................................18
4.3 Selecting a suitable probe ............................................................................................ 21
4.3.1 Mounting and dismounting of the probes .....................................................................22
4.3.1.1 Mounting and dismounting the titanium plates .............................................................23
4.3.1.2 Mounting and dismounting of micro and tapered tips and long
probes ..........................................................................................................................24
4.4 Mounting and dismounting of the standard and booster horns ....................................25
5 Cleaning and maintenance of the homogeniser ...........................................................27
4 / 44 51436a GB/2017-10
1electronic GmbH & Co. KG • Heinrichstraße 3-4 • 12207 Berlin • Deutschland • [email protected]

5.1 Cleaning and care ........................................................................................................27
5.2 Treatment of contaminated parts in the ultrasonic transducer, vessels and accessories
pertaining to the medical field .......................................................................................28
5.3 Warehousing / storage .................................................................................................28
6 Maintenance and repair ................................................................................................29
6.1 Maintenance .................................................................................................................29
6.2 Functional checks .........................................................................................................29
6.3 Error analysis ...............................................................................................................30
6.4 Repairs and service ......................................................................................................32
6.4.1 Decontamination certificate ..........................................................................................32
7 Accessories ..................................................................................................................33
7.1 Required accessories ...................................................................................................33
7.2 Optional accessories ....................................................................................................33
7.3 Preparations - not applicable - ....................................................................................34
8 Consumable materials - not applicable - .....................................................................34
9 Taking the unit out of service ........................................................................................ 34
10 Key words .....................................................................................................................34
Informative appendices
A Options and accessories
B Spanner for mounting/dismounting
C Decontamination - sample copy
5 / 4451436a GB/2017-10
1electronic GmbH & Co. KG • Heinrichstraße 3-4 • 12207 Berlin • Deutschland • [email protected]

1
3
6
3a
4
5
2
7
GM 2070 and GM 2200
10
12
11
GM 2070-U and GM 2200-U
10a
10b
12
11
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.
• Operating and display panel (2)
• Ultrasonic transducer (3) with Start/Stop
key (3a)
• Ultrasonic oscillating system (4)
• Booster horn (5)
• Probe (6)
• Mains switch (7)
Product features on the rear side of the HF generator:
• Depending on type, with mains cable (10) or mains socket (10a) with fuse holder and, if needed,
with a switch (10b) for voltage selection.
• HF socket (11)
• Remote control socket(12)
6 / 44 51436a GB/2017-10
1electronic GmbH & Co. KG • Heinrichstraße 3-4 • 12207 Berlin • Deutschland • [email protected]

1.1 Mode of operation
The HF generator transforms the mains energy input (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 the same frequency of 20 kHZ
are generated on the tip of the probe and transferred into the sonication medium as ultrasound
waves with a high power intensity. 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 and/or booster 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 ultrasonichomogenisers 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
SONOPULS ultrasonic homogenisers are also used for in-vitro diagnostic lab procedures, to
procure information from the handling of organic materials with ultrasound. Therefore, they are
classified and treated in accordance with the Directive 98/79/EC on in-vitro diagnostic medical
devices.
7 / 4451436a GB/2017-10
1electronic GmbH & Co. KG • Heinrichstraße 3-4 • 12207 Berlin • Deutschland • [email protected]

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.
1.4 Technical data
SONOPULS ultrasonic homogenisers are interference-free and marked with a (-.
Safety: EN 61010-1,
EMC: EN 61326-1
/
1.4.1 HF Generator (GM)
Generator GM 2070 GM 2200 GM 2070-U GM 2200-U
HF power/2 70 W 200 W 70 W 200 W
HF frequency 20 kHz 20 kHz 20 kHz 20 kHz
Mains connection 230 V~ (± 10 %) 50/60 Hz 115 V~ or 230 V~ (± 10 %) 50/60 Hz
Weight 2.5 kg 5.5 kg
Dimensions
(l × w × h) 257 × 180 × 115 mm 255 × 272 × 115 mm
8 / 44 51436a GB/2017-10
1electronic GmbH & Co. KG • Heinrichstraße 3-4 • 12207 Berlin • Deutschland • [email protected]

Protected against access to
dangerous parts with a wire.
Protected against solid foreign
bodies with a diameter of 1 mm or
larger.
Protected from
dripping water.
Cable length: 2 m
Ultrasound frequency: 20 kHz ± 500 Hz
Frequency control/1: Automatic
Time setting range: 0:00:01 – 99:59 [h:mm:ss] or continuous operation
Ultrasound operating mode: Pulsating or continuous
Amplitude setting range: 10 - 100 % in 1 % steps
Operating elements: Control dial, membrane keypad
Operating data display: LED display, illuminated
Remote control (turn on/off): Button on the ultrasonic transducer, potential-free contact,
foot switch TS 8 (optional)
Degree of protection: IP 41
pursuant to DIN EN 60529
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
Condensation not allowed.
Only for indoor operation.
/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.
/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 permitted peak value. In the
case of highly viscous media, this can also result in the desired amplitude not always being reached.
9 / 4451436a GB/2017-10
1electronic GmbH & Co. KG • Heinrichstraße 3-4 • 12207 Berlin • Deutschland • [email protected]

Protected against access to
dangerous parts with fingers.
Protected against solid foreign
bodies with a diameter of 12 mm
or larger.
Not
protected
against
ingress of
water.
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 German Medical Devices Operator Ordinance (MPBetreibV):
Start-up on location, functional check
and personnel training (section 5): not required
Technical safety check (STK) (section 6): no specifications
Technical measurement check (MTK) (section 11): not applicable
e-procurement
e-cl@ss:
HD device classification: 32-08-02-02
HD accessories classification: 32-08-92-03
1.4.2 Technical data, ultrasonic transducers (UW)
UW 2070 / UW 2200
PZT ultrasonic oscillating system: 
Start/Stop key: 
Suitable for continuous
operation: 
Frequency: 20 kHz
Weight: 1.2 kg
Dimensions: Ø 70 × 120 mm
Degree of protection: IP 20 according to
DIN 60529
For environmental conditions, see chapter 1.4.1.
10 / 44 51436a GB/2017-10
1electronic GmbH & Co. KG • Heinrichstraße 3-4 • 12207 Berlin • Deutschland • [email protected]