BANDELIN SONOREX DIGITEC Manuel utilisateur

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]

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 2 GmbH & Co. KG, Heinrichstrasse 3–4, Germany, 12207 Berlin,

Tel.: +49-30-768 80 - 0, Fax: +49-30-773 46 99, [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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1electronic GmbH & Co. KG • Heinrichstraße 3-4 • 12207 Berlin • Deutschland • [email protected]

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

SONOREX DIGITEC DT 102 H

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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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1electronic GmbH & Co. KG • Heinrichstraße 3-4 • 12207 Berlin • Deutschland • [email protected]

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

9 / 361566g GB/2019-02

1electronic GmbH & Co. KG • Heinrichstraße 3-4 • 12207 Berlin • Deutschland • [email protected]

/* 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

10 / 36 1566g GB/2019-02

1electronic GmbH & Co. KG • Heinrichstraße 3-4 • 12207 Berlin • Deutschland • [email protected]

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.

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