BANDELIN SONOREX DIGITEC User manual

3 D / 3 D-RC
Ultrasonic baths for aqueous fluids
User instructions
Valid for:
DT 31, DT 31 H, DT 52, DT 52 H
DT 100, DT 100 H, DT 102 H, DT 102 H-RC, DT 103 H, DT 106
DT 156, DT 156 BH
DT 255, DT 255 H, DT 255 H-RC
DT 510, DT 510 H, DT 510 H-RC, DT 512 H
DT 514, DT 514 H, DT 514 BH, DT 514 BH-RC
DT 1028, DT 1028 H, DT 1028 CH
DT 1050 CH
1566g GB/2019-02

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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.
All images are provided as examples and are not true to size. Decorative elements are not included in the scope of delivery.
© 2019
1 2 GmbH & Co. KG, Heinrichstrasse 3–4, Germany, 12207 Berlin,
Tel.: [phone] - 0, Fax: [phone], [email protected]
(

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1electronic GmbH & Co. KG • Heinrichstraße 3-4 • 12207 Berlin • Deutschland • [email protected]
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/modifications, 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:
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 Warning
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.
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
3.1.2 Heating .........................................................................................................................13
3.2 Miscellaneous functions - not applicable - ...................................................................14
3.2.1 Degas ( - in time area)..............................................................................................14
3.2.2 Block/unblock continuous operation ( - in time area).................................................. 14
3.2.3 Remote control ...............................................................................................................14
4 Use ...............................................................................................................................15
4.1 Instructions for use .......................................................................................................15
4.2 General use ..................................................................................................................17
4.3 Treatment of medical and dental instruments .............................................................. 20
4.4 Further information .......................................................................................................21
4.4.1 Degassing ....................................................................................................................21
4.4.2 Disposal of sonication fluids .........................................................................................21

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5 Cleaning and maintenance of the ultrasonic bath ........................................................22
5.1 Cleaning and care ........................................................................................................22
5.2 Disinfection for medical applications ............................................................................22
5.3 Warehousing / storing ................................................................................................... 22
6 Maintenance and repair ................................................................................................23
6.1 Maintenance .................................................................................................................23
6.2 Functional checks .........................................................................................................23
6.3 Error analysis ...............................................................................................................23
6.4 Repairs and service ......................................................................................................24
7 Accessories ..................................................................................................................25
7.1 Required accessories ...................................................................................................25
7.2 Preparations .................................................................................................................25
8 Taking the unit out of service ........................................................................................26
Informative appendices
A Dosing table
B Accessories
C Foil test

SONOREX DIGITEC DT 31
13
4
2
5
SONOREX DIGITEC DT 102 H
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 ... oder SONOREX DIGITEC DT ....-RC
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 transducers, 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)
• As of type DT 102 H, drain outlet with ball valve (6) for easy discharge of bath liquid and
handles (7)
• Depending on model, comes with heating (type "H"), infrared interface with the bottom side
(types “RC”) or a special oscillating tank (types "C")
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 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
SONOREX ultrasonic baths are intended for the sonication of aqueous fluids. 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-fixative 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/1 recommendations in "Hygiene requirements for the treatment of medical products"
and other applicable domestic regulations. Additional information in this respect can be found in
chapter 4.3.
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

Protected against access by
instruments to dangerous
components, protected
against solid foreign bodies
with a diameter of 2.5 mm
or larger
Protected from the access to
dangerous parts with
the finger
Protection from bodies with
a diameter of larger than
12 mm
Protected from
dripping water up to
60° from its vertical
axis
Protected from
dripping water up to
60° from its vertical
axis
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1electronic GmbH & Co. KG • Heinrichstraße 3-4 • 12207 Berlin • Deutschland • [email protected]
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
IP 23 (DIGITEC-RC)
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.
Bath type Order
No.
Interior dimensions
(L × W × D)
Operat-
ing
volume
Outlet
(valve)
Ultrasonic peak
power* / Ultrasonic
nominal output
Weight
(net)
Heating
power
Current
consump-
tion
(230 V)
Current
consump-
tion
(115 V)
mm l W / Weff kg W A A
DT 31 3200 190 × 85 × 60 0.6 - 160 / 40 2.0 - 0.2 0.4
DT 31 H 3220 190 × 85 × 60 0.6 - 160 / 40 2.3 70 0.5 1.0
DT 52 3205 150 × 140 × 100 1.2 - 240 / 60 2.4 - 0.3 0.6
DT 52 H 3225 150 × 140 × 100 1.2 - 240 / 60 2.5 140 0.9 -
DT 100 3210 240 × 140 × 100 2.0 - 320 / 80 3.2 - 0.4 0.7
DT 100 H 3230 240 × 140 × 100 2.0 - 320 / 80 3.3 140 1.0 2.0
DT 102 H 3235 240 × 140 × 100 2.0 G ¼ 480 / 120 4.0 140 1.2 2.3
DT 102 H-RC 3071 240 × 140 × 100 2.0 G ¼ 480 / 120 4.0 140 1.2 2.3
DT 103 H 3201 240 × 140 × 150 2.5 G ¼ 560 / 140 4.2 200 1.5 -
DT 106 3270 Ø 240 × 130 4.0 G ¼ 480 / 120 5.2 - 0.6 1.1
DT 156 3275 500 × 140 × 100 4.0 G ¼ 640 / 160 6.0 - 0.7 1.4
DT 156 BH 3221 500 × 140 × 150 6.0 G ¼ 860 / 215 7.2 600 3.6 7.1
DT 255 3215 300 × 150 × 150 3.8 G ¼ 640 / 160 4.8 - 0.7 1.4
DT 255 H 3240 300 × 150 × 150 3.8 G ¼ 640 / 160 4.8 280 2.0 3.9
DT 255 H-RC 3081 300 × 150 × 150 3.8 G ¼ 640 / 160 4.8 280 2.0 3.9

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/* In order to improve the effect the ultrasound is being modulated whereby a 4-fold ultrasonic nominal output value is yielded as
ultrasonic peak power.
Specifications for use as a medical device
Name: Ultrasonic bath
UMDNS nomenclature (ECRI / DIMDI): 14-263
Purpose: See chapter 1.2.
Classification (Medical Device
Directive 93/42/EWG, Appendix IX): Class I; active, non-invasive,
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.
Specifications 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 specifications
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 reconfiguring the ultrasonic bath or
the shield.
Bath type Order
No.
Interior dimensions
(L × W × D)
Operat-
ing
volume
Outlet
(valve)
Ultrasonic peak
power* / Ultrasonic
nominal output
Weight
(net)
Heating
power
Current
consump-
tion
(230 V)
Current
consump-
tion
(115 V)
mm l W / Weff kg W A A
DT 510 3245 300 × 240 × 150 6.6 G ½ 640 / 160 7.3 - 0.7 -
DT 510 H 3206 300 × 240 × 150 6.6 G ½ 640 / 160 7.4 400 2.5 -
DT 510 H-RC 3091 300 × 240 × 150 6.6 G ½ 640 / 160 7.4 400 2.5 -
DT 512 H 3226 300 × 240 × 200 8.7 G ½ 860 / 215 8.2 400 2.7 5.4
DT 514 3250 325 × 300 × 150 9.0 G ½ 860 / 215 8.5 - 1.0 1.9
DT 514 H 3211 325 × 300 × 150 9.0 G ½ 860 / 215 8.7 600 3.6 7.1
DT 514 BH 3216 325 × 300 × 200 12.5 G ½ 860 / 215 9.8 600 3.6 7.1
DT 514 BH-RC 3095 325 × 300 × 200 12.5 G ½ 860 / 215 9.8 600 3.6 7.1
DT 1028 3255 500 × 300 × 200 19.0 G ½ 1200 / 300 13.9 - 1.4 -
DT 1028 H 3231 500 × 300 × 200 19.0 G ½ 1200 / 300 14.6 1300 7.0 14.0
DT 1028 CH 3266 500 × 300 × 300 30.0 G ½ 1200 / 300 23.3 1450 7.7 15.3
DT 1050 CH 3271 600 × 500 × 300 60.0 G ½ 2400 / 600 37.0 1950 11.1 17.9

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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 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. 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 fluids.
• 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 fluid 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 field
• 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.