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.
All images are provided as examples and are not true to size. Decorative elements are not included in the scope of delivery.
1 electronic GmbH & Co. KG • Heinrichstraße 3-4 • 12207 Berlin • Deutschland • info@bandelin.com
General
The device, the accessories and the preparations are to be used in accordance with the
operating 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 (chapter 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/modifi cations, both the warranty claim and the CE conformity will expire.
If service is required, please contact the specialist dealer in charge or the manufacturer.
Symbols used:
SymbolSignifi canceExplanation
Danger
Caution
WarningWarning
ImportantIdentifi es information that is important for execution.
NoteIdentifi es information provided for explanatory purposes.
Medical noteIdentifi es information that is important for medical use.
Do not grip insideFor health reasons, touching the oscillating fl uid is prohibited.
Wear ear protectors
Operating sequence
instructions
Identifi es information that could signify a risk to life and limb,
especially through electric shock, if not observed.
Identifi es 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.
For health reasons, standing for long periods of time in the
vicinity of the device without ear protectors is prohibited.
Identifi es instructions that are to be followed in the described
sequence.
1 electronic GmbH & Co. KG • Heinrichstraße 3-4 • 12207 Berlin • Deutschland • info@bandelin.com
8 Taking the unit out of service ........................................................................................25
Informative appendices
A Accessories
B Foil test
C Dosing table
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1 Product description
Ultrasonic bath of type SONOREX SUPER RK ... .
The exact type specifi cation 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 transducers, ultrasound frequency 35 kHz
• Time switch for 1 - 15 min and continuous operation (2)
• Filling level mark for safe fi lling (3)
• Compact, easy to clean stainless steel housing (4)
• Rubber feet for safe positioning (5)
• As of type RK 102 H, drain outlet with ball valve (6) for easy discharge of bath liquidand
handles (7)
• Depending on model, comes with heating (type "H") or a special oscillating tank (types "C")
13
13
4
4
7
2
SONOREX SUPER RK 31 H
5
5
SONOREX SUPER RK 102 H
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 liquid with
ultrasound frequency as mechanical oscillations. As a result, microscopically small bubbles
are continuously formed in the bath liquid, which release energy upon imploding and generate
local micro currents. This process is called cavitation. During 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 liquid fl ows in. During sonochemical
processes, cavitation may have a catalytic effect, e.g. with the production of stable emulsions or
the rapid degasifi cation of fl uids with a high gas content.
SONOREX ultrasonic baths are effi ciently supported by SweepTec
SweepTec® immediately balances load-dependent working point fl uctuations to the optimal
working point using fast frequency modulation. This produces an especially homogeneous and
uniform ultrasound fi eld in the bath volume for constantly reproducible results.
®
automatic frequency control.
6
2
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1 electronic GmbH & Co. KG • Heinrichstraße 3-4 • 12207 Berlin • Deutschland • info@bandelin.com
1.2 Purpose
General application
SONOREX ultrasonic baths are intended for the sonication of aqueous fl uids. They work on the
basis of low-frequency ultrasound and can be used in versatile ways. Their main application is
gentle and intensive cleaning of objects of diverse shapes, types and sizes. Alternatively, chemical
processes can be favourably supported and accelerated in an ultrasonic bath, e.g. when preparing
or treating samples.
Sonication is always carried out in connection with a suitable preparation that is added to the bath
liquid. In order to use the device as intended, a basket or another inset beaker, into which objects
are placed during sonication, is also required. Only in this manner is the optimum diffusion of the
ultrasound guaranteed.
The ultrasonic bath is operated from the front. The operation is usually carried out on a table.
Ultrasound treatment of medical instruments
SONOREX ultrasonic baths are used to treat medical instruments:
a) during manual treatment
b) before machine treatment
c) after machine treatment
In this connection, they are to be used together with suitable, non-fi xative disinfection and/or
detergent preparations, in order to support or expedite their effect. Pursuant to section 2, para. 1
and section 3, paras. 1, 9 and 10 of the Medical Devices Act (MPG), the ultrasonic bath thus
becomes a medical device as an accessory to the preparations, and is to be treated as one.
This includes pre- and post-processing steps for the medical instruments, e.g. the observance
of KRINKO
and other applicable domestic regulations. Additional information in this respect can be found in
chapter 4.3.
/1
recommendations in "Hygiene requirements for the treatment of medical products"
1.3 CE conformity
SONOREX ultrasonic baths are declared as medical products/2 and satisfy the CE marking criteria
for the European
- "Medical Device" directive
- "Low-voltage directive"
- "Electromagnetic compatibility" directive
- WEEE - Directive
in their currently valid versions.
A declaration of conformity can be requested from the manufacturer by providing the serial
number.
/1 In Germany: Empfehlung der Kommission für Krankenhaushygiene und Infektionsprävention (KRINKO) beim Robert Koch-Institut (RKI)
und des Bundesinstitutes für Arzneimittel und Medizinprodukte (BfArM); Bundesgesundheitsblatt - 2012•55:1244-1310.
/2 Exception: see "Technical data" overview
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1.4 Technical data
SONOREX ultrasonic baths are interference-free and CE-marked.
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 label
Degree of protection: IP 32 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.
non-implantable medical device
Type, model, serial number, year of manufacture: See type plate on the rear side for information
The ultrasonic bath has been inspected pursuant to norms currently in effect and is to be installed
and put into operation pursuant to EMC directions.
Specifi cations pursuant to the Medical Devices Operator Ordinance (MPBetreibV):
Startup on location, functional check
and personnel training (section 4): not required
Technical safety controls, (STK, section 11): no specifi cations
Technical measurement controls, (MTK, section 14): not applicable
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.
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 reconfi guring the ultrasonic bath or
the shield.
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During operation, portable or mobile HF communication systems in the vicinity of the ultrasonic
bath should be turned off - their operation may be disrupted.
1.5 Warnings and safety precautions
General
• Keep the ultrasonic bath out of the reach of children and persons who have not been instructed
in its 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 infl uences.
• 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. A binding statement
for wearers of implants can only be made at the place of work and together with the implant
manufacturer, however. 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 chapter 1.4.
• Only plug in the ultrasonic bath to an outlet with a grounded socket.
• Do not operate the ultrasonic bath without fl uids.
• Do not stand or lay any objects on the tank bottom, accessories must be used, see chapter 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 ultrasonic fl uid during ultrasound operation.
Danger: Ultrasounds have 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.
• When preheating the bath liquid, stir at least every 15 min. or switch on the ultrasound. Danger:
Scalding due to retardation of boiling.
• Do not operate the ultrasonic bath while unattended.
Advice for the medical fi eld
• The ultrasonic bath is exclusively intended for use by medical skilled personnel.
• When handling contaminated instruments, relevant personnel protection regulations are to be
observed.
• When treating instruments, the instructions of the instrument manufacturer are to be followed.
• Ultrasound cleaning is especially suited for instruments made of stainless steel and hard
plastics. Do not treat lenses, camera systems or light cables with ultrasound.
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1 electronic GmbH & Co. KG • Heinrichstraße 3-4 • 12207 Berlin • Deutschland • info@bandelin.com
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 power plug immediately.
• Repairs are only to be conducted by authorised skilled personnel or by the manufacturer.
• Defective parts may only be replaced with original SONOREX parts.
2 Preparation
Carefully unpack the ultrasonic bath and accessories and inspect them for completeness
or possible transportation damages. If any damages or defects are found, these are to be
immediately notifi ed in writing to the transportation company and to the supplier.
Before startup, the ultrasonic bath is to be left to stand at its operating location for 2 hours so that
it may adapt to the ambient conditions.
2.1 Scope of delivery
1 Ultrasonic bath, optionally with heating - see delivery note
1 Ball valve (brass, galvanized) with hose, as of type RK 102 H, packaged separately with
sealing tape and assembly instructions
1 Instruction manual
Additional accessories according to order - see delivery note
2.2 Set-up / assembly
• Place the ultrasonic bath atop a fi rm, level and dry surface. In doing so
- observe the maximum weight of the ultrasonic bath, including fl uid.
Net weight see technical data chapter 1.4.
- do not block the air supply below the ultrasonic bath.
- guard against moisture and wetness - risk of electric shock.
• In the case of ultrasonic baths with a drain outlet, mount the ball valve, hose socket and hose,
which are included in the delivery, pursuant to the enclosed assembly instructions.
2.3 Start-up
Thoroughly rinse the ultrasonic bath's oscillating tank with water before its fi rst use.
Verify that the control buttons are in the "off" position, i.e. the switch indicator above or the
toggle switch is set to "0", then connect the ultrasonic bath to the mains (grounded socket).
Conduct function test - briefl y plug in the ultrasound (maximum of 1 to 2 seconds), a hissing
noise should be heard. Set to "0" once again.
It is recommended that a foil test be conducted as part of quality assurance prior to the fi rst
use.
This test is to be saved for later comparison, see appendix for information.
If applicable, hang accessories in the ultrasonic bath and place lid on top.
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11 / 361556g GB/2019-02
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