BANDELIN Sonorex Digitec DT 510 F User manual

3 D Series F
Ultrasonic baths for preparation of samples
User instructions
Valid for:
DT 510 F and DT 1028 F
51326c GB/2017-06

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1electronic GmbH & Co. KG • Heinrichstraße 3-4 • 12207 Berlin • Deutschland • [email protected]
Copyright & limitation 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 difference in the translation is not binding and has no legal effect.
In case of any discrepancies between the translation and the original of this document, the original version has priority.
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.
© 2017
1 2 GmbH & Co. KG, Heinrichstrasse 3–4, Germany, 12207 Berlin,
Tel.: [phone] - 0, Fax: [phone], [email protected]

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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 are to be stored in the vicinity of the device
for later reference. This also applies if possession of the device is transferred.
Before the device is put into operation, these User Instructions are to be read carefully and
completely in order for the user to become familiarised with all functions.
The warnings and safety precautions (Section 1.5) are always to be followed 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 !conformity will expire.
If any 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, to prevent damage to the device and danger to
the user.
When device parts are labelled with this symbol, reference
must be made to the documentation.
Warning Warns of a hot surface.
Important Identifies information that is important for execution.
Note Identifies information provided for explanatory purposes.
Medical note Identifies information that is important for medical use.
In vitro diagnostics
information
Identifies information that is important for in vitro diagnostics
applications.
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.
Operating sequence
instructions
Identifies instructions that are to be followed in the described
sequence.

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Contents
1 Product description .........................................................................................................6
1.1 Mode of operation ..........................................................................................................6
1.2 Purpose ..........................................................................................................................7
1.3 CE conformity .................................................................................................................7
1.4 Technical data ................................................................................................................8
1.4.1 Electromagnetic ambient conditions (EMC) ...................................................................9
1.5 Warnings and safety precautions ................................................................................. 10
2 Preparation ................................................................................................................... 11
2.1 Scope of delivery .......................................................................................................... 11
2.2 Set-up / assembly ......................................................................................................... 11
2.3 Start-up ......................................................................................................................... 11
3 Operation ......................................................................................................................12
3.1 Operating elements ......................................................................................................12
3.1.1 Ultrasound ....................................................................................................................12
3.2 Ultrasound signals - not applicable - .............................................................................13
3.3 Special functions ..........................................................................................................13
4 Use ...............................................................................................................................13
4.1 Fill oscillating tank ........................................................................................................14
4.2 Degassing the fluid .......................................................................................................15
4.3 Ultrasound operation ....................................................................................................16
4.4 Empty the oscillating tank............................................................................................... 17
4.5 Further information .......................................................................................................17
4.5.1 Degassing ....................................................................................................................17
4.5.2 Disposal of sonication fluids .........................................................................................17
5 Cleaning and maintenance of the ultrasonic bath ........................................................18
5.1 Cleaning and care ........................................................................................................18
5.2 Disinfection for medical applications ............................................................................18

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5.3 Warehousing / storing ................................................................................................... 18
6 Maintenance and repair ................................................................................................19
6.1 Maintenance .................................................................................................................19
6.2 Functional checks .........................................................................................................19
6.3 Error analysis ...............................................................................................................19
6.4 Repairs and service ......................................................................................................20
6.4.1 Decontamination certificate ..........................................................................................20
6.4.2 Exchanging fuses .........................................................................................................20
7 Accessories ..................................................................................................................21
7.1 Required accessories ...................................................................................................21
7.2 Optional accessories - not applicable - ......................................................................... 21
7.3 Preparations .................................................................................................................21
8 Consumable materials - not applicable - .....................................................................22
9 Taking the unit out of service ........................................................................................22
10 Key words .....................................................................................................................22
Informative appendices
A Accessories
B Foil test
C Decontamination - sample copy

SONOREX DIGITEC DT 510 F
13
4
6
7
2
5
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1electronic GmbH & Co. KG • Heinrichstraße 3-4 • 12207 Berlin • Deutschland • [email protected]
1 Product description
Ultrasonic bath of type SONOREX DIGITEC DT ... F user instructions.
The exact type specification and serial number are found on the type plate, on the rear side of the
ultrasonic bath.
Product features:
• Stainless steel oscillating tank (1) with high-grade PZT high-performance ultrasonic systems,
ultrasound frequency 35 kHz
• Digital timer for 1, 2, 3, 4, 5, 10, 15, 30 min and continuous operation (2)
• Filling level mark for safe filling (3)
• Compact, easy to clean stainless steel housing (4)
• Rubber feet for safe positioning (5)
• Outlet with ball valve (6) for easy draining of the bath fluid and handles (7)
1.1 Mode of operation
SONOREX ultrasonic baths use the effect of cavitation. Under their oscillating tank bottoms
they contain piezoelectric transducers, the energy of which is transferred to the bath fluid with
ultrasound frequency as mechanical oscillations. As a result, microscopically small bubbles
are continuously formed in the bath fluid, which release energy upon imploding and generate
local micro currents. This process is called cavitation. During the cleaning processes, it causes
contamination to be regularly "blasted" from the hard surfaces of the objects being treated. At
the same time, dirt particles are dispersed and fresh bath fluid flows in. During sonochemical
processes, cavitation may have a catalytic effect, e.g., with the production of stable emulsions or
the rapid degasification of fluids with a high gas content.
SONOREX ultrasonic baths are efficiently supported by SweepTec®automatic frequency control.
SweepTec®immediately balances load-dependent working point fluctuations to the optimal
working point using fast frequency modulation. This produces an especially homogeneous and
uniform ultrasound field in the bath volume for constantly reproducible results.

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1.2 Purpose
General application
The SONOREX ultrasonic baths with their flat baths were developed for the preparation of
samples in laboratories, clinics and academic research.
With corresponding accessories, it is possible to sonicate samples in laboratory flasks of different
shapes and sizes. The samples can be sonicated both for a defined time and also in continuous
operation. It is not permissible to prepare objects to be cleaned in the ultrasonic baths.
Application examples:
- Preparation of samples
- Even, indirect sonication of the samples
- Homogenisation
- Rapid degasification of samples
e.g., in medical diagnostics, environmental and foodstuff analysis and ultrasonic chemistry.
Sonication is always carried out in connection with a suitable preparation that is added to the bath
fluid.
For correct use, the supplied beaker holder or another holder is required for storing the inset
beakers with the samples during the sonication. Nothing must stand or lie directly on the bottom of
the bath – this is the only way to ensure optimal diffusion of the ultrasound.
The ultrasonic bath is operated from the front. The operation is usually carried out on a table.
In vitro diagnostic laboratory procedures (preparation of samples)
The SONOREX ultrasonic baths can be used for in vitro diagnostic preparation or laboratory
procedures (e.g., preparation of samples) in which medical information is gathered from the
ultrasonic treatment of organic or inorganic material.
In this case, they are classified and treated in accordance with the Directive 98/79/EC on in vitro
diagnostic medical devices.
1.3 CE conformity
SONOREX ultrasonic baths 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.

Protected against access by
instruments to dangerous
components,
protected against solid
foreign bodies with a
diameter of 2.5 mm or larger
Protected from splashes
up to 60° from its vertical
axis
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1.4 Technical data
SONOREX ultrasonic baths are interference-free and !.
Safety: EN 61010-1,
EMC: EN 61326-1
Mains supply: 230 V~ (± 10 %) 50/60 Hz, (115 V upon request), mains cable length 2 m
Protection class: Class I
Frequency 35 kHz
Oscillating tank: Stainless steel
Serial number (SN): See type plate on the rear side of the ultrasonic bath
Degree of protection: IP 33 according to DIN 60529
Ambient conditions according to EN 61 010-1
Overvoltage category: II
Degree of contamination: 2
Permissible ambient temperature: 5 to 40 °C
Permissible relative humidity up to 31°C: 80%
Permissible relative humidity up to 40°C: 50%
No dewing.
Only for indoor operation.
Specifications for use as a medical device
Name: Ultrasonic bath SONOREX DIGITEC ... F
UMDNS nomenclature (ECRI / DIMDI): 14-263
Purpose: See Section 1.2.
Classification (in acc. with
Directive 98/79/EC for IVD): Device category 5 device
Type, model, serial number, year of manufacture: See type plate on the rear side of the device
The ultrasonic bath has been inspected pursuant to the currently applicable standards and is to be
installed and put into operation pursuant to EMC directions, see Section 1.4.1.
Specifications pursuant to the Medical Devices Operator Ordinance (MPBetreibV):
Startup at location, functional check
and personnel training (§ 5): Not required
Technical safety controls, (STK, § 6): No specifications
Technical measurement controls, (MTK, § 11): Not applicable

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Bath type Order no. Interior dimensions
(L × W × D)
Operating
volume
Outlet
(valve)
Ultrasonic peak
power* / Ultrasonic
nominal output
Weight
(net)
Current
consump-
tion
Fuses for
generator
mm l W / Weff kg A
DT 510 F 3242 300 × 240 × 65 2.5 G ½ 560 / 140 5.5 0,7 F2A
DT 1028 F 3243 500 × 300 × 65 5.8 G ½ 1280 / 320 10 1.4 F2A
/* In order to improve the effect the ultrasound is being modulated whereby, depending upon the ultrasonic bath, a 4- or 8-fold
Ultrasonic nominal output value is yielded as ultrasonic peak power, in connection with SweepTec.
1.4.1 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.

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1.5 Warnings and safety precautions
General
• Keep the ultrasonic bath out of the reach of children and also of persons who have not been
instructed in their operation by reference to these instructions.
• We will not offer a guarantee for damages to the ultrasonic bath or oscillating tank, or to the
objects to be treated, as a result of use of inadequate disinfection agents or detergents.
• Keep the surface of the ultrasonic bath and operating elements clean and dry.
• Do not expose the ultrasonic bath to corroding influences.
• Move the ultrasonic bath only when it is empty.
• Empty the ultrasonic bath only while turned off.
• Ultrasonic baths adhere to prescribed EMC limit values, such that it can be assumed that the
electromagnetic radiation emanating from the units is harmless to humans. However, a binding
statement for wearers of implants can only be made at the place of work and together with the
implant manufacturer. In case of doubt, information regarding the allowable electromagnetic
exposure level is to be obtained from the implant manufacturer.
Operation
• Observe ambient and set-up conditions, see Section 1.4.
• Only plug in the ultrasonic bath to an outlet with a grounded socket.
• Do not operate the ultrasonic bath without fluids.
• Do not stand or lay any objects on the tank bottom, accessories must be used, see Section 7.
• Do not immerse any parts of the body (e.g., hands, feet) or living beings (animals or plants)
into the tank; in particular, do not immerse them in the bath fluid during ultrasound operation.
Danger: Ultrasound has a cell-destroying effect.
• In the event of continuous activity within a 2 m radius, adequate hearing protection must be
used. Danger: Hearing disturbances during operation when not wearing hearing protection – the
typical ultrasound cavitation noise can be very uncomfortable.
• Do not operate the ultrasonic bath while unattended.
Advice for the medical and laboratory field
• The ultrasonic bath is exclusively intended for use by medical skilled personnel.
• It may generate radio interferences or disrupt the operation of devices nearby. It may be
necessary to take remedial measures such as realigning the device or a reconfiguration of the
ultrasonic bath or the shield.
• During operation, portable or mobile HF communication systems in the vicinity of the ultrasonic
bath should be turned off – their operation may be disrupted.
Damages
• If damage to the ultrasonic bath is detected, do not connect the ultrasonic bath to the mains.
• In the event of defects, disconnect the mains plug immediately.
• Repairs are only to be conducted by authorised skilled personnel or by the manufacturer.
• Defective parts may only be replaced with original parts.