Bandelin RK 52, RK 514, RK 510, RK 52 H, RK 512 H User Manual

User instructions

36

Ultrasonic baths for aqueous fluids

Valid for:

RK 31, RK 31 H, RK 52, RK 52 H

RK 100, RK 100 H, RK 102 H, RK 103 H, RK 106

RK 156, RK 156 BH

RK 170 H

RK 255, RK 255 H

RK 510, RK 510 H, RK 512 H

RK 514, RK 514 H, RK 514 BH

RK 1028, RK 1028 H, RK 1028 C, RK 1028 CH

RK 1040, RK 1050, RK 1050 CH

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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

12GmbH & Co. KG, Heinrichstrasse 3–4, Germany, 12207 Berlin, Tel.: [phone] - 0, Fax: [phone], [e-mail]

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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.
			Identifies information that is to be observed and adhered to
			without fail, to prevent damage to the device and danger to
		Caution	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	Identifies instructions that are to be followed in the described
		instructions	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
4	Use ...............................................................................................................................	14
4.1	Instructions for use .......................................................................................................	14
4.2	General use ..................................................................................................................	16
4.3	Treatment of medical and dental instruments ..............................................................	19
4.4	Further information .......................................................................................................	20
4.4.1	Degassing ....................................................................................................................	20
4.4.2	Disposal of sonication fluids .........................................................................................	20
5	Cleaning and maintenance of the ultrasonic bath ........................................................	21
5.1	Cleaning and care ........................................................................................................	21
5.2	Disinfection for medical applications ............................................................................	21
5.3	Warehousing / storing ...................................................................................................	21

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6	Maintenance and repair ................................................................................................	22
6.1	Maintenance .................................................................................................................	22
6.2	Functional checks .........................................................................................................	22
6.3	Error analysis ...............................................................................................................	22
6.4	Repairs and service ......................................................................................................	23
7	Accessories ..................................................................................................................	24
7.1	Required accessories ...................................................................................................	24
7.2	Preparations .................................................................................................................	24
8	Taking the unit out of service ........................................................................................	25

Informative appendices

AAccessories

BFoil test

CDosing table

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1 Product description

Ultrasonic bath of type SONOREX SUPER RK ... .

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

• Time switch for 1 - 15 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 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")

		1	3
1	3
			7
		4
	4
	2		6
			2
SONOREX SUPER RK 31 H	5	5

SONOREX SUPER RK 102 H

1.1Mode 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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1.2Purpose

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 preand 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.

1.3CE 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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1.4Technical 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
								Protected against access by					Protected from
Ambient conditions according to EN 61 010-1									instruments to dangerous				dripping water
Overvoltage category:							II	components, protected against solid up to 15° from its
								foreign bodies with a diameter of						vertical axis
Degree of contamination:							2			2.5 mm or larger
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.
					Operat-		Ultrasonic peak						Current		Current
	Order		Interior dimensions			Outlet	power* / Ultra-			Weight	Heating		consump-		consump-
Bath type					ing
	No.		(L × W × D)			(valve)	sonic nominal			(net)	power		tion		tion
					volume
								output					(230 V)		(115 V)
			mm		l			W / Weff		kg	W		A		A
RK 31	329		190 × 85	× 60	0.6	-		160 / 40		2.2	-		0.2		0.4
RK 31 H	7523		190 × 85	× 60	0.6	-		160 / 40		2.3	70		0.5		1.0
RK 52	311		150 × 140	× 100	1.2	-		240 / 60		2.4	-		0.3		0.6
RK 52 H	164		150 × 140	× 100	1.2	-		240 / 60		2.6	140		0.9		1.8
RK 100	301		240 × 140	× 100	2.0	-		320 / 80		3.2	-		0.4		0.7
RK 100 H	312		240 × 140	× 100	2.0	-		320 / 80		3.4	140		1.0		2.0
RK 102 H	303		240 × 140	× 100	2.0	G ¼		480 / 120		4.1	140		1.2		2.3
RK 103 H	326		240 × 140	× 150	2.5	G ¼		560 / 140		4.3	200		1.5		3.0
RK 106	306		Ø 240 × 130		4.0	G ¼		480 / 120		5.2	-		0.6		1.1
RK 156	305		500 × 140	× 100	4.0	G ¼		640 / 160		6.0	-		0.7		1.4
RK 156 BH	646		500 × 140	× 150	6.0	G ¼		860 / 215		7.3	600		3.6		7.1
RK 170 H	7506		1000 × 200 × 200		26.0	G ½	1520 / 380			26.2	1600		8.7		17.3
RK 255	3066		300 × 150	× 150	3.8	G ¼		640 / 160		4.8	-		0.7		1.4
RK 255 H	316		300 × 150	× 150	3.8	G ¼		640 / 160		5.0	280		2.0		3.9
RK 510	327		300 × 240	× 150	6.6	G ½		640 / 160		7.2	-		0.7		1.4
RK 510 H	321		300 × 240	× 150	6.6	G ½		640 / 160		7.4	400		2.5		4.9

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					Operat-			Ultrasonic peak				Current	Current
	Order		Interior dimensions				Outlet	power* / Ultra-	Weight	Heating		consump-	consump-
Bath type					ing
	No.		(L × W × D)				(valve)	sonic nominal	(net)	power		tion	tion
					volume
								output				(230 V)	(115 V)
				mm	l			W / Weff	kg	W		A	A
RK 512 H	795		300	× 240 × 200	8.7		G ½	860 / 215	8.3	400		2.7	5.4
RK 514	277		325	× 300 × 150	9.0		G ½	860 / 215	8.8	-		1.0	1.9
RK 514 H	207		325	× 300 × 150	9.0		G ½	860 / 215	8.8	600		3.6	7.1
RK 514 BH	263		325	× 300 × 200	12.5		G ½	860 / 215	9.8	600		3.6	7.1
RK 1028	322		500	× 300 × 200	19.0		G ½	1200 / 300	14.0	-		1.4	2.7
RK 1028 C	661		500	× 300 × 300	30.0		G ½	2000 / 500	24.5	-		2.2	-
RK 1028 H	324		500	× 300 × 200	19.0		G ½	1200 / 300	14.7	1300		7.0	14.0
RK 1028 CH	143		500	× 300 × 300	30.0		G ½	1200 / 300	23.4	1450		7.7	15.3
RK 1040	319		Ø 500 × 195		28.0		G ½	1520 / 380	19.4	-		1.7	3.4
RK 1050	323		600 × 500 × 200		41.0		G ½	2400 / 600	30.0	-		2.7	5.3
RK 1050 CH	184		600 × 500 × 300		60.0		G ½	2400 / 600	36.0	1950		11.1	17.9
/* 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

1.4.1Electromagnetic 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.

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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.

1.5Warnings 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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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 notified 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.

2.1Scope of delivery

1 Ultrasonic bath, optionally with heating - see delivery note

1Ball 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

2.2Set-up / assembly

•Place the ultrasonic bath atop a firm, level and dry surface. In doing so

-observe the maximum weight of the ultrasonic bath, including fluid. 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.

2.3Start-up

Thoroughly rinse the ultrasonic bath's oscillating tank with water before its first 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 - briefly 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 first 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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