user instructions - bandelin · user instructions 3 ze built-in ultrasonic baths valid for: ze 1031...

Control unit ST 30 DTControl unit ST 15.1 or

Installation example

User instructions

3 ZE built-in ultrasonic baths

valid for:

ZE 1031 ZE 1032 ZE 1058 ZE 1059

ZE 1031 DT ZE 1032 DT ZE 1058 DT ZE 1059 DT

6386e GB/2019-06

2 / 38 6386e GB/2019-061 electronic 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-language original is the binding version of this document. Any differences in the translation are not binding and have no legal effect. In case of any discrepancies between the translation and the original of this document, the original version will take precedence.

BANDELIN accepts no responsibility or liability for damage caused by improper handling or usage contrary to the intended purpose.

The documentation has been prepared with great care. All liability is excluded for any direct or indirect losses resulting from incomplete or erroneous information contained in this documentation, or in its presentation or usage.

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, 12207 Berlin, Germany

Tel.: +49-30-768 80 - 0, Fax: +49-30-773 46 99, [email protected]

(

6386e GB/2019-06 3 / 381 electronic GmbH & Co. KG • Heinrichstraße 3-4 • 12207 Berlin • Deutschland • [email protected]

General

The equipment, the accessories and the preparations are to be used in accordance with the Instructions for Use 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 elsewhere.

Before the device is put into operation, these 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 heeded 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 become void.

If service is required, please contact the specialist dealer in charge or the manufacturer.

Symbols used:

Symbol Meaning Explanation

DangerUsed to mark information that, if not observed, could constitute a risk to life and limb, especially as a result of electric shock.

Caution Used to mark information that must be observed and complied with in order to avoid damage to the device or injury to the user.

Warning Warning of hot surface.

Important Identifi es information that is important for implementation.

Note Used to mark explanatory information.

Medical note Identifi es information that is important for medical use.

Do not grip inside For health reasons, touching the oscillating fl uid is prohibited.

Wear hearing protection

For health reasons, remaining for long periods of time in the vicinity of the device without hearing protection is prohibited.

Instructions Identifi es instructions that must be followed in the described sequence.


Table of Contents

1 Product description ......................................................................................................6

1.1 Mode of operation ........................................................................................................7

1.2 Purpose ........................................................................................................................8

1.3 CE conformity ...............................................................................................................8

1.4 Technical data ..............................................................................................................9

1.4.1 Degrees of protection .................................................................................................11

1.4.2 Electromagnetic compatibility (EMC) .........................................................................11

1.5 Warnings and safety precautions ...............................................................................12

2 Preparation .................................................................................................................13

2.1 Scope of delivery ........................................................................................................14

2.2 Set-up / assembly ......................................................................................................14

2.3 Start-up ......................................................................................................................14

3 Operation ...................................................................................................................15

3.1 Control elements of the ST 15.1 ................................................................................15

3.1.1 Ultrasound ..................................................................................................................15

3.1.2 Miscellaneous functions - not applicable - ...................................................................15

3.2 Control elements of the ST 30 DT ..............................................................................16

3.2.1 Ultrasound ..................................................................................................................16

3.2.2 Special functions of the ST 30 DT ..............................................................................17

4 Use .............................................................................................................................18

4.1 Instructions for use .....................................................................................................18

4.2 General application ....................................................................................................20

4.3 Treatment of medical and dental instruments ............................................................22

4.4 Further information .....................................................................................................23

4.4.1 Degassing ..................................................................................................................23

4.4.2 Disposal of sonication fl uids .......................................................................................23


5 Cleaning and maintenance of the ultrasonic bath ......................................................24

5.1 Cleaning and care ......................................................................................................24

5.2 Disinfection .................................................................................................................25

5.3 Positioning / Storage ..................................................................................................25

6 Maintenance and repair .............................................................................................25

6.1 Maintenance ...............................................................................................................25

6.2 Function test / functional check ..................................................................................26

6.3 Error analysis .............................................................................................................26

6.4 Repairs and service ...................................................................................................27

6.5 Decontamination certifi cate ........................................................................................27

7 Accessories ................................................................................................................28

7.1 Required accessories .................................................................................................28

7.2 Optional accessories ..................................................................................................29

7.3 Preparations ...............................................................................................................30

8 Consumable materials - not applicable - ......................................................................32

9 Decommissioning .......................................................................................................32

10 Key words - not applicable - ................................................................................................. 32

Informative annexes

A Dosing and application instructions for STAMMOPUR agents

B Foil test

SONOREX ZE 1031

1

3

5

2

SONOREX ZE 1031 DT

1

4

5

2

example: Upright or hanging ultrasound generator

6

Back of ultrasound generator

87


1 Product description

Multi-part SONOREX ZE or SONOREX ZE ... DT ultrasonic bath designed for integration in an existing work surface. The exact type specifi cation and, where applicable, the serial number are found on the type plate of the respective unit part.

Product features:• Ultrasonic oscillating tank (1) with transducers on the tank bottom or additionally on

a tank wall, ultrasonic frequency 35 kHz• Filling level mark for safe fi lling (2)• Separate control unit for installation in the front panel of the cupboard, optionally with

mechanical timer for 1-15 mins and continuous operation (3) or with digital timer for 1, 2, 3, 4, 5, 10, 15, 30 mins, continuous operation and temperature control (4)

• Separate ultrasound generator (5) for installation or space-saving mounting in the cupboard below. On the back with connections for the control unit (7) and the ultrasonic oscillating tank (8).

1 4 (ST 30 DT)

5


1.1 Mode of operation SONOREX ZE ultrasonic baths use the effect of cavitation. Under their oscillating tank bottoms or additionally on the tank well 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 fl uid, releasing energy upon imploding and generating local microcurrents. This process is called cavitation. During the cleaning process, contamination is "blasted" from the hard surfaces of the objects being treated. At the same time, dirt particles are removed and fresh bath liquid fl ows in.

SONOREX ZE ultrasonic baths are effi ciently supported by SweepTec® automatic frequency control. 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.

SONOBOARD Standard functional cabinet


1.2 Purpose General useSONOREX ZE 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 the gentle and intensive cleaning of objects of diverse shapes, types and sizes.

Sonication is always carried out together with a suitable preparation that is added to the bath fl uid. In order to use the device as intended, a basket or other inset beaker is required, into which objects are placed during sonication. An optimum diffusion of the ultrasound can only be guaranteed in this manner.

The ultrasonic bath is to be operated from the front if possible, and should always be operated with the bath installed.

Ultrasound treatment of medical instruments SONOREX ZE 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 RKI recommendations in "Hygiene requirements for the treatment of medical products"/1 and other applicable domestic regulations. Additional information in this respect can be found in Chapter 4.3.

1.3 CE conformity SONOREX ZE ultrasonic baths are declared as medical products and satisfy the CE marking criteria for the European

- “Medical Devices” directive - "Low-voltage directive" - "Electromagnetic Compatibility" Directive - RoHS – Directive

in their currently valid versions.

A declaration of conformity can be requested from the manufacturer by providing the serial number.

/1 Recommendation of the German Commission for Hospital Hygiene and Infection Prevention (KRINKO) at the Robert Koch Institute (RKI) and the German Federal Institute for Drugs and Medical Devices (BfArM); Federal Health Gazette - 2012•55:1244-1310


1.4 Technical data SONOREX ZE ultrasonic baths are interference-free and marked with a CE.Safety: EN 61010-1;EMC: EN 61326-1

Ultrasonic TE oscillating tank, SW rinsing tank - 2 m cable with AMP-CPC connector - Degree of protection: IP 30 pursuant to DIN EN 60529 (see Chapter 1.4.1)

Ultrasonic bath Model Materials

Interior dimensions

(LxWxD) mm

Capac-ity (L)

Outlet

Exterior dimensions

(LxWxH) mm

ZE 1031 /DTTE 1031 Stainless

steel, 2 mm, welded

510 × 300 × 200/220 20.0 Bead 1½"570 × 360 × 270/290

SW 31 Z 570 × 360 × 205/225


steel, 2 mm, welded

510 × 300 × 200/220 20.0 Bead 1½"570 × 404 × 270/290

SW 31 Z 570 × 360 × 205/225

ZE 1058 /DTTE 1058.2 Stainless

steel, 2 mm, welded

600 × 400 × 200/220 32.0 Bead 1½"660 × 460 × 270/290

SW 58 Z 660 × 460 × 205/225


steel, 2 mm, welded

600 × 400 × 200/220 32.0 Bead 1½"660 × 504 × 270/290

SW 58 Z 660 × 460 × 205/225

Ultrasound generator - Operating voltage: 230 V~ (± 10 %) 50/60 Hz- Ultrasound frequency: 35 kHz- Fuse: F2A- IP class: IP 20 pursuant to DIN EN 60529 (see Chapter 1.4.1)

Ultrasonic bath Model

Ultrasonic peak power

W

Rated ultrasonic

outputW

Current consump-

tionA

External dimensions

(L×W×H)mm

ZE 1031 /DT GT 503 M-C 1200 300 1.4 360 × 310 × 142

ZE 1032 /DT GT 504 M-C 1760 440 1.9 360 × 310 × 142

ZE 1058 /DT GT 1003 M-C 2400 600 2.7 360 × 310 × 142

ZE 1059 /DT GT 1003 M-C 2400 600 2.7 360 × 310 × 142

In order to improve the effect, the ultrasound is modulated, resulting in the HF power value being increased 4-fold as peak ultrasonic power.

Please note:SONOBOARD Standard technical data corresponds to that of the ZE 1058 DT, which is delivered in a functional cabinet already installed and ready for operation.


Control unit ST 15.1- Mechanical timer, 1 to 15 mins and continuous operation- Fuse: G 5×20 6.3 A, medium time lag- Connections:

- Approx. 2 m mains cable with safety plug for connection to mains. - Approx. 2 m mains cable with IEC connector for connection to the ultrasound

generator. - Degree of protection: IP 30 pursuant to DIN EN 60529 (see Chapter 1.4.1)

Control unit ST 30 DT- Digital timer, 1, 2, 3, 4, 5, 10, 15, 30 mins, continuous operation, temperature display- Fuse: 2x - G 5×20 6.3 A, medium time lag- Connections:

- Approx. 2 m mains cable with safety plug for connection to mains. - Approx. 2 m mains cable with IEC socket for connection to the ultrasound

generator. - Approx. 2 m data cable with connector for connection to the temperature

sensor.- Degree of protection: IP 30 pursuant to DIN EN 60529 (see Chapter 1.4.1)

Ambient conditions pursuant to EN 61 010-1Overvoltage category: IIDegree of soiling: 2Permissible ambient temperature: 5 to 40°CPermissible relative humidity up to 31°C: 80 %Permissible relative humidity up to 40°C: 50 %No dewing allowed.For indoor operation only.

Specifi cations for use as a medical deviceName: Ultrasonic bathUMDNS nomenclature (ECRI / DIMDI): 14-263Purpose: See chapter 1.2.Classifi cation (in acc. withDirective 93/42/EEC, Appendix IX): Class I; active, non-invasive, non-

implantable medical deviceType, model, serial number, year of manufacture: See type plate for information

The ultrasonic bath has been inspected according to applicable standards and must be installed and operated according to EMC directions; see Chapter 1.4.2.

Specifi cations pursuant to the German Medical Devices Operator Ordinance (MPBetreibV):Start-up on location, functional check and personnel training (section 4): not required

Protected against access by fi ngers to hazardous parts;

protected against solid foreign bodies with a diameter of

12 mm or larger

Protected against access of instruments to dangerous

components, protected against solid foreign bodies with a

diameter of 2.5 mm or larger

No protection against the

penetration of water

No protection against the

penetration of water


Technical safety controls, (STK, section 11): no specifi cationsTechnical measurement controls, (MTK, section 14): not applicable

1.4.1 Degrees of protection

IP 20 pursuant to DIN EN 60529

IP 30 pursuant to DIN EN 60529

1.4.2 Electromagnetic compatibility (EMC) The device has been checked for electromagnetic compatibility in accordance with DIN EN 61326-1 and meets the requirements for Class B devices in accordance with EN 55011. It is suitable for use in institutions and other areas that are directly connected to a public low-voltage power supply, e.g., medical laboratory facilities.It may generate radio interference or disrupt the operation of devices nearby. It may be necessary to take remedial measures such as realigning the device or reconfi guring 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.


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 ultrasound generator surfaces and the control unit clean and dry.

• Do not expose the ultrasonic bath to corroding infl uences.

• 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 ultrasonic baths 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. In case of doubt, information regarding the allowable electromagnetic exposure level should be obtained from the implant manufacturer.

Operation • Never operate the oscillating tank without the cover on the transducers!

• Only turn on the generator if the bath is connected (HF cable) – never run the generator without a load.

• 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 use a rubber plug or stand pipe on the oscillating tank's outlet!

• 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 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 ultrasonic fl uid 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 perceived as uncomfortable.

• When used for extended periods, the bath fl uids heat up. For this reason, it is important to check the temperature when treating temperature-sensitive parts.

• Do not leave the ultrasonic bath unattended while in operation.


Advice for the medical fi eld• The ultrasonic bath is exclusively intended for use by skilled medical 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 suitable for instruments made of stainless steel and hard plastics. Do not treat lenses, camera systems or light cables with ultrasound.

• A combined disinfection and cleaning of medical instruments in the ultrasonic bath is only possible with the use of special preparations (with the corresponding microbiological certifi cates). Ultrasound alone will not disinfect them!

Damage• 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 SONOREX parts.

2 Preparation

Carefully unpack the ultrasonic bath components and accessories, and inspect them for completeness or possible transportation damages. If any damage or defects are found, these must be immediately notifi ed in writing to the transportation company and to the supplier.Before operation, the ultrasonic bath should be allowed to stand for 2 hours at its operating location so that it can adjust to the ambient conditions.


2.1 Scope of delivery 1 Ultrasonic oscillating tank1 Ultrasound generator with bracket for vertical installation1 Preinstalled control unit with front panel and fi xation materials for installation in the

front panel of the work surface, optionally including temperature sensor (ST 30 DT)1 manual

Additional accessories according to order - see delivery slip

2.2 Set-up / assembly The installation of the ultrasonic bath must be conducted by authorised skilled personnel, under reference to the installation instructions. When doing so:

• Observe the maximum weight of the ultrasonic bath, including fl uid. • Do not obstruct the air supply to the ultrasound generator. • Protect the generator from moisture and wetness – risk of electric shock. • If the ultrasonic bath comes with a drain set, this must be installed in accordance

with the supplied installation instructions.

SONOBOARDOnce utilities have been connected, SONOBOARD is ready for use. Setup must be in the vicinity of the following connections:

• Power supply: Earthed socket outlet 230 V~ (± 10%), 50/60 Hz• Suitable fi lling fi tting (spray, spigot, dosing unit)• Outlet for emptying the ultrasonic oscillating tank

Engage the locking brakes on the front casters to secure SONOBOARD from accidental movement.

2.3 Start-up Thoroughly rinse the ultrasonic bath's oscillating tank with water before its fi rst use.

On the control unit ST 15, check that the operating button is in the "Off" position, i.e., that the switch indicator is pointing upwards to "0".

Connect the ultrasonic bath to the power supply (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, place accessories in the ultrasonic bath and place lid on top.

1 Green control light (Ultrasound in operation)

2 Turning knob for Ultrasound ON / OFF with preset time

21


3 Operation

The ultrasound is controlled from the front using the control unit. Depending on the control unit delivered, information on the operation can be found in the following sections.

3.1 Control elements of the ST 15.1

3.1.1 Ultrasound The ultrasound is operated through the turning knob (timer).

Timed operation:• Turn knob to the right set time from 1 to 15 minutes.

- Green control light fl ashes.- Once the time has elapsed, the time switch automatically

turns off.• By turning the knob back, the operating time will be shortened, i.e. the ultrasonic

bath will be turned off.

Continuous operation:• Turn knob to the left so it locks into place position ∞.

- Green control light fl ashes.- The ultrasonic bath does not turn off automatically; to switch it off turn the knob

to the right, back to "0".

Notes:• While turned off, the ultrasonic bath may remain connected to the mains. It can be

disconnected from the mains by pulling the mains plug.• The timer switch "locking" can hardly be felt if mains voltage is not present, e.g. if the

mains plug is disconnected or a fuse has blown.The timer only works if mains voltage is present.

3.1.2 Miscellaneous functions - not applicable -

4

21 3

1 Ultrasonic bath ON/OFF button2 Preset time button 3 Start/Stop button – Ultrasound4 LEDs for temperature and time


3.2 Control elements of the ST 30 DT

3.2.1 Ultrasound With the ultrasonic bath turned on – ON/OFF button – the time is preset, then the ultrasound output is turned on with the Start/Stop button.

Timed operation:• Setting via pressing buttons Time 1, 2, 3, 4, 5, 10, 15 or 30 minutes

- LED for set time lights up yellow.- Following pressing of the Start/Stop button, a running light displays

the remaining time optically.- Once the time expires, the ultrasonic output is stopped automatically.

• Premature pressing of the Start/Stop button ends the ultrasound output.

Continuous operation: • Setting via pressing buttons LED ∞ lights up green

- Following pressing of the Start/Stop button, the top (green) LED lights up constantly and LEDs fl ashing every second (running light downwards) signal ultrasound activity.

- Ultrasonic bath does not turn off automatically: press the Start/Stop button to switch it off.

Notes:• While turned off, the ultrasonic bath may remain connected to the mains. It can be

disconnected from the mains by pulling the mains plug.• For safety reasons, the ultrasound bath is turned off automatically if no button is

pressed for more than 12 hours.


3.2.2 Special functions of the ST 30 DT Temperature scale:• Display accuracy: ± 2.5 K. • The "!" LED lights up red when the temperature of 40°C is exceeded and the

respective LED of the currently achieved bath temperature fl ashes.

Degas:• The DEGAS function is used to degas the unit before the treatment. The required

time can be set with the time setting button if desired. Then, keep the Start/Stop button depressed for at least 2 seconds. You can switch it off early by pressing the Start/Stop button again.During degassing, in addition to the countdown, the top green LED ( ) also fl ashes.

• Switching between ultrasound – degas: If the Start/Stop button is kept depressed for a long time when ultrasound is running, the ultrasound is fi rstly switched off and then after approx. 2 seconds the Degas function is reactivated.

Locking continuous operation ( - in the time scale area)To avoid accidentally turning on the continuous operation, the continuous operation can be deactivated:

Pull the power plug. Press the preset time button, hold it depressed and insert the mains plug at the

same time. The yellow LED "1 min" lights up in confi rmation.

The function can be reactivated in the same way. The green LED continuous operation ( ) lights up in confi rmation.

Sonication fl uid

Basket holder with basket


4 Use

Direct sonicationNormally, sonication takes place directly in the oscillating tank. For this purpose, the objects to be treated are placed in a basket and placed on a basket holder inside the oscillating tank which is fi lled with sonication fl uid.

4.1 Instructions for use Instructions - fi lling• Verify that the outlet is closed.• The ultrasound bath must be turned off. • Do not fi ll oscillating tank with hot water. Maximum fi lling temperature: 50°C.• Water of at least drinking quality must be used to fi ll the oscillating tank.• Water without additives is not suitable for sonication. BANDELIN recommends

TICKOPUR or STAMMOPUR preparations.• The fi ll level must always be at or slightly above the fi lling level mark. A low fi ll level

will damage the ultrasonic bath!• Do not use any combustible, explosive, non-aqueous liquids or azeotropic mixtures

directly in the stainless steel oscillating tank (e.g. benzine, solvents). Furthermore, chemicals that contain or that separate chloride ions (some disinfectants, household cleaners, and dish detergents), may not be used directly in the stainless steel tank.

• When working with aggressive preparations in inset beakers or insert tubs: Prevent the contact liquid or stainless steel surfaces from being sprayed. If necessary, replace the contact liquid, clean the surfaces and wipe dry.

• When using preparations, the safety instructions included in the respective product leafl ets and safety data sheets are fundamentally to be adhered to.

• Replace used sonication fl uids, do not refresh by adding fl uids.

Notes - Inserting objects• Fully remove air bubbles from cavities (e.g. blind holes). Indirect sonication

Fully remove possible air bubbles from underneath the vessels.


Notes - Temperature• Ultrasound energy warms up the sonication fl uid (even without additional heating).

The temperature of the bath fl uid can increase rapidly if the ultrasound is active for long periods of time and/or the oscillating tank is covered. For this reason, the temperature must be controlled when treating temperature-sensitive components.

• For an optimum bath temperature, observe the specifi cations of the specimen manufacturer!

• Mix disinfectant with cold water, run ultrasonic bath without heating, avoid temperatures of >40°C.

2/3

Oscillating tank with basket holder


4.2 General application Step 1: Fill oscillating tankThe oscillating tank is fi lled with water and a suitable preparation to reduce the surface tension, see Chapter 7.3.

Direct sonication Fill 1/3 of oscillating tank with

water.

Add dosed preparation to the oscillating tank. See appendix for dosage information.

Fill carefully up to the fi lling level mark, avoid as much as possible the formation of foam.

Step 2: Degassing the fl uidFreshly-fi lled bath fl uid or fl uid that has remained in the oscillating tank for a longer period of time must be degassed prior to use. See also section 4.4.1.

Remove basket and other accessories from the oscillating tank.

Place lid on top.

Set the degassing time and start the ultrasound (control unit ST 15.1) or activate the DEGAS function (control unit ST 30), see Section 3.

- up to 10 litres bath volume: 10 min- more than 10 litres bath volume: 30 minTime may need to be extended with acidic cleaning solutions.

Step 3: Insert objects to be treatedBefore sonicating each time, check whether the service life of the bath fl uid has expired, or whether the bath fl uid is contaminated and needs to be replaced.

Direct sonication Place the basket holder in the oscillating tank. Place the inset

basket on the basket holder.

Check that the objects to be treated are fully covered with fl uid.

Check the fi ll level.

For cleaning tasksPlace the objects to be cleaned in the appropriate accessories, in doing so please note:• Evenly distribute parts, do not stack them.• An overloading of the basket or inset beaker reduces the ultrasound effect (the

ultrasound is absorbed). • Place the more heavily soiled side facing downward.• Parts with joints are to be fully opened before placing inside.


• Delicate parts are not to come into contact with one another - for positioning, use special accessories such as silicone knob mats if necessary, see Chapter 7.2.

• Due to the design, the ultrasound effect is weaker on the outlet side. Do not place more heavily soiled objects in the basket over the outlet.

Step 4: Ultrasound – operationFundamentally, the sonication time is to be as short as possible in order to protect the objects to be treated and the oscillating tank. In the case of disinfection fl uids, the length of time will depend on the concentration of the preparation used. In the case of stubborn residue, it may be necessary to conduct sonication for a longer time.

Place lid on top.

Set the required sonication period and start the ultrasound, see Chapter 3.

Step 5: Remove treated objectsAfter sonication, the objects are to be removed from the ultrasonic bath. Allowing them to remain any longer in the bath fl uid may damage them.

Turn off the ultrasound.

Remove the basket or inset beaker from the tank and set down atop a level surface.

Depending on the length of sonication, the baskets and objects may be hot!

After the cleaning processes, rinse the treated objects with water of at least drinking quality. Next, visually check the sonication results.

Before the next sonication, verify the service life of the bath fl uid. Heed the specifi cations of the preparation manufacturer. If necessary, empty the oscillating tank.

Step 6: Empty the oscillating tankLayers of contamination on the tank bottom reduce the ultrasonic output. The oscillating tank is to be emptied after a long period of use or sonication of heavily soiled objects, see Chapter 4.4.2.

Turn off the ultrasonic bath.

Empty the oscillating tank by opening the drain.

After emptying the oscillating tank, thoroughly rinse it. Wipe dry with a soft cloth.For additional care instructions, see Chapter 5.1.


4.3 Treatment of medical and dental instruments • The disinfection and cleaning of medical instruments in a single step follows the

general sonication procedure, see Chapter 4.2. • A combined disinfection and cleaning of medical instruments in the ultrasonic

bath is only possible with the use of special preparations (with the corresponding microbiological certifi cates). Ultrasound alone will not disinfect them!

• Only disinfecting agents and/or detergents that are non-affi xing may be used. • In terms of concentration, temperature, and sonication time, the manufacturer

specifi cations for the disinfecting agent and/or detergent used are to be strictly adhered to.

• The compatibility between the instrument and the preparation is to be verifi ed on the basis of the respective manufacturer's specifi cations.

• The service life of the disinfection solution pursuant to the manufacturer specifi cations is to be heeded. The cleaning solution is to be immediately replaced if contamination is evident. It is to be replaced, however, at least every work day.

• Prepare instruments appropriately, e.g., by rinsing them with cold water of at least drinking quality, fully separating / opening them! Adhere to the instructions of the respective instrument manufacturer.

• Operate the ultrasonic bath with a lid or beneath a suctioning system. • Further treat instruments after sonication in accordance with RKI recommendations/2.

In other countries, the relevant supplementary/divergent national regulations should be taken into account.

• Adhere to OSHA safety measures (e.g., protective clothing, protective goggles, suitable gloves).

Special case "thorough cleansing" In the case of stained, crusted or oxidised instruments, a thorough cleansing is recommended. The thorough cleansing is carried out as indirect sonication in a plastic insert tub, using a special detergent (see Chapter 7.2).

/2 Recommendation of the German Commission for Hospital Hygiene and Infection Prevention (KRINKO) at the Robert Koch Institute (RKI) and the German Federal Institute for Drugs and Medical Devices (BfArM); Federal Health Gazette - 2012•55:1244-1310


4.4 Further information 4.4.1 Degassing

The degassing of the sonication fl uid increases the ultrasound effect.Freshly fi lled-in fl uid or fl uid that has remained in the oscillating tank for a longer period of time must be degassed prior to use. Gases dissolved in the fl uid (e.g. oxygen) are reduced through degassing and the ultrasound effect is thus signifi cantly improved.

The cavitation noise changes during degassing, loud degassing noises fade away at the end of the degassing process and the ultrasonic bath appears to work more quietly. A lower noise level, however, does not mean a reduction in ultrasonic power. Rather, it signifi es the end of the degassing process and an improvement in the ultrasound effect.

4.4.2 Disposal of sonication fl uids The working solution is disposed of pursuant to the specifi cations in the product leafl et and the label supplied by the manufacturer of the preparations employed. All aqueous preparations made by DR H. STAMM GmbH are prepared pursuant to the regulations of the German Washing and Cleansing Agents Act, are biodegradable and as working solutions may be disposed of in the wastewater. Strongly acidic and strongly alkaline fl uids are to be previously neutralised pursuant to technical data sheet specifi cations. The manufacturer’s specifi cations for the respective preparations should be observed. During cleaning, materials hazardous to water such as oils, heavy metal compounds, etc., depending on the type of contamination, may enter the working solution. If the limit values are exceeded, the working solution must be reconditioned (removal of contaminants) or be disposed of as toxic waste. Disinfection and cleaning agents that become contaminated when used are considered “waste material” pursuant to the German Waste Act (AbfG) and may not be taken back by the manufacturer. In other countries, the relevant supplementary/divergent national regulations should be taken into account.In every case, the statutory provisions and regulations of municipal wastewater plants must be adhered to. Information is provided by municipal wastewater plants as well as by environmental agencies.


5 Cleaning and maintenance of the ultrasonic bath

To achieve an optimum lifespan for the ultrasonic bath, cleaning and maintenance should be conducted regularly.

CAUTION! Disconnect the ultrasonic bath / ultrasound generator from the mains before cleaning / maintenance.

Do not rinse or immerse the ultrasonic bath and ultrasound generator in water and do not expose them to splash water.

No guarantee will apply to damage caused by the use of unsuitable surface disinfection agents or detergents.

5.1 Cleaning and care Oscillating tankThe oscillating tank of an ultrasonic bath is a wearing part. It is continuously exposed to cavitation during ultrasound operation. Dirt particles remaining in the tank abrade and damage the tank surface due to the movement of the fl uid, therefore• Rinse the oscillating tank with water thoroughly and frequently and dry using a soft

cloth.• Regularly remove residue from the edges of the oscillating tank using a commercial

stainless steel cleaning product without any abrasive additives. • Do not use steel wool, scrapers or graters for cleaning / maintenance.• Metal particles that remain on the stainless steel surface as well as rust particles

from the water pipe system penetrate the passive protective layer of the stainless steel. The stainless steel is "activated" in this process and it begins to rust. The extraneous rust produces localised corrosion of the stainless steel. For this reason, remove metal parts such as screws, fi lings, etc. from the oscillating tank, and immediately remove rust stains using a soft cloth and a commercial stainless steel cleaning product without abrasive additives.

Ultrasound generator housing• Do not use any abrasive cleaners, only commercial care products without abrasive

additives.• The housing is to be wiped off only from the outside with a moist cloth; afterwards,

allow to dry or wipe dry.


5.2 Disinfection If contaminated medical instruments are treated in the ultrasonic bath, hygienic safety after use is important. In order to avoid any cross-contamination as a result of the settling of microorganisms, especially along the tank edge and in the drain outlet area, but also on the user interfaces, these areas are to be regularly cleaned and disinfected pursuant to the hygiene plan using a VAH-certifi ed or effective surface disinfectant.Accessories such as holders and baskets should be processed regularly in a cleaning and disinfection device.

5.3 Positioning / Storage During long periods of non-use, the ultrasonic bath should be stored in a cool, dry location. The lid should be placed on top in order to protect the oscillating tank from outside contamination.

6 Maintenance and repair

6.1 Maintenance SONOREX ZE ultrasonic baths require no maintenance.For purposes of regular inspection, the following functional checks may be carried out.


6.2 Function test / functional check Check the control light on the ST 15.1• Pursuant to Chapter 3.1.1.

Check the control lights on the ST 30 DT• A test routine can be started for an internal function check:

To do so, the ultrasonic bath must be switched off. When the Start/Stop button is pressed and held, the ultrasonic bath is switched on with the ON/OFF button. All LEDs light up successively for 1/3 of a second. The last set values are then displayed. The test is then successfully completed.If there are any deviations, the ultrasonic bath must be sent in for checking/repairs.

Check the ultrasound effect• For this check, it is recommended that a foil test be conducted (semi-annually).

The oscillating tank is delivered along with a frame suitable for foil tests. Ordinary aluminium foil is used to conduct the test. Next, a comparison is made with previously-generated foils. For more detailed information, please see the appendix.

A measurement procedure is described in DIN SPEC 40170:2013-11 (measurement and evaluation of the cavitation noise).

6.3 Error analysis SONOREX ultrasonic baths are robustly constructed and designed for a high level of reliability. Nevertheless, the possibility of a malfunction due to a defective component can never be fully discounted. The following overview of possible sources of error should serve as an aid for error detection and elimination.

• Ultrasonic bath oscillates weakly, unevenly, or noise is too loud:- Has fl uid been properly degassed?

- Is it overloaded with objects to be treated?

- Uneven noises (wobbling)

See Chapter 4.2 / Step 2 : Degassing the fl uid.

Remove a few parts.

No error – slightly adjust the fi ll level of the fl uid.

• Slight erosion visible on the tank bottom? Natural wear.Ultrasonic bath OK.

Any malfunctions must be communicated in writing to the manufacturer.


6.4 Repairs and service If errors or defects are identifi ed during the functional check and cannot be rectifi ed, the ultrasonic bath may no longer be used. In such cases, please contact the supplier or the manufacturer:

BANDELIN electronic GmbH & Co. KGHeinrichstraße 3-412207 BerlinGermany

Repair service: E-mail:Tel.: +49-(0)-30 – 768 80 – 13 [email protected]: +49-(0)-30 – 76 88 02 00 13

In the event of returns, the General Terms and Conditions for Delivery and Payment of BANDELIN electronic GmbH & Co. KG apply.In addition, the ultrasonic bath must be cleaned and decontaminated (if necessary), see the following chapter. If you identify errors or defects that cannot be rectifi ed by repairs performed by the manufacturer, the entire unit must be sent in for repairs (oscillating tank, user unit and generator).

6.5 Decontamination certifi cate If the ultrasonic bath is sent back to the manufacturer for repairs (with accessories, if applicable), the form "Certifi cate of Decontamination" must be fi lled out and affi xed to the packaging on the outside, in a visible spot.If this form has not been fi lled out, we reserve the right to refuse receipt of the package in order to protect our employees.

The form can be downloaded from our website as a PDF fi le:www.bandelin.com - Downloads ...


7 Accessories

The right accessories make handling the ultrasonic application easier while protecting the oscillating tank and the objects to be treated.

BANDELIN offers a wide range of accessories.Additional information may be obtained from our supplier, our sales representatives or our website.

No-obligation telephone consultation: Website: +49-(0)-30 – 768 80 – 0 www.bandelin.com

7.1 Required accessories Drain set- G 1 ½, model V with Bowden-cable button

- Order No.: 3166

Please note: The SONOBOARD is delivered with the drain set already installed.

Stainless steel inset baskets- Mesh size 5 × 5 mm, load capacity up to 10 kg- Basket holder required

Model Order no.

Suitable for ultrasonic bath Interior dimensions (L × W × H)

mm

K 29 EM (= 1/1 DIN) 688 ZE... /DT: 1031, 1032, 1058, 1059 470 × 240 × 45

(ISO baskets) – ZE… /DT: 1058, 1059 –

KT 30, KT 57 KT 30 Z, KT 57 Z


Stainless steel basket holders,- load capacity up to 10 kg

Model Order no. Suitable for ultrasonic bath Exterior dimensions (L × W × H)

mm

KT 30 (= 1/1 DIN) 7517 ZE… /DT: 1031, 1032 470 × 270 × 50

KT 57 (= 1/1 DIN + ISO) 7504 ZE… /DT: 1058, 1059 570 × 370 × 50

KT 30 Z (= 1/1 DIN) 7507 ZE… /DT: 1031, 1032 492 × 270 × 190

KT 57 Z (= 1/1 DIN) 3078 ZE… /DT: 1058, 1059 560 × 370 × 190

Please note:Do not stand or lay any objects directly on the tank bottom. Exceptions to this rule are special basket holders that have been designed by BANDELIN in such a manner that they are not located in the cavitation fi eld and do not damage the tank bottom.

7.2 Optional accessories Stainless steel lid- protection from disinfecting and cleaning agent fumes,- muffl ing of the process-related cavitation noise,- protection of the disinfecting and cleaning agent in the oscillating tank from

environmental contamination,- prevent unauthorised reaching into the device during operation.

Model Order no. Suitable for ultrasonic bath

D 30 7522 ZE… /DT: 1031, 1032

D 57 7520 ZE… /DT: 1058, 1059

D 1058 G* 3232 ZE… /DT: 1058, 1059

* Hinged lid with gas spring and EPDM profi le seal.

FE 12 fi xed in basket


Silicone knob mats- For use in baskets for gentle, contact-free cleaning of sensitive

parts, e.g. of micro instruments

Model Order no. Suitable for ultrasonic bath Dimensions (L × W) mm

SM 29 178 ZE… /DT: 1031, 1032, 1058, 1059 470 × 245

Fixation clamps FE 12 - Set (2× large, 5× small) for fi xating fl exible endoscope

accessories on the bottom of the basket

- Order No. 117

Insert tubs made of plastic, with lid - For basic cleaning with STAMMOPUR GR

Model Order no. Suitable for ultrasonic bath Dimensions (L × W × H)

mm

KW 28-0 717 ZE… /DT: 1031, 1032 437 × 230 × 155

Foil test frame FT ... - Used in functional testing; see Appendix B for sizes and order numbers.

7.3 Preparations Special preparations are required for use of the ultrasound that are ultrasound-compatible, i.e. they are cavitation-conducive, biodegradable, easily disposable, gentle to the material, and long-lasting.

BANDELIN recommends the TICKOPUR or STAMMOPUR concentrates by DR. H. STAMM GmbH, which have been especially developed for ultrasound use and which utilise the ultrasound optimally. Additional information may be obtained from our supplier, our sales representatives, or from our website.

No-obligation telephone consultation: Website: +49-(0)-30 – 768 80 – 280 www.dr-stamm.de


IMPORTANT! • When using preparations, the safety instructions included on the labels and in the

respective product leafl ets and safety data sheets are fundamentally to be adhered to.

• Keep the preparations out of the reach of children and also of persons who have not been instructed in their use by reference to the product information.

• Do not ingest or inhale the preparations and do not allow them to come into contact with the eyes or skin.

• Preparations in powder form may only be used fully dissolved.

STAMMOPUR disinfection agents and detergents These agents have been specially developed for use with ultrasound. They:- disinfect and clean in one single step (STAMMOPUR DR 8);- are cavitation-conducive – optimum use of the ultrasound;- are biodegradable.

Depending on the intended use, the following agents have proven their worth:

STAMMOPUR DR 8 Aldehyde-free, chlorine-free and phenol-free concentrate for disinfection and intensive cleaning in one step, with anti-corrosive mildly alkaline, pH 9.4 (1%) Application 1-3%Bactericidal, tuberculocidal, yeasticidal, virucidal against Vaccinia, BVDV, papovavirus, adenovirus, HBV, HCV, HIV, avian fl u - A-Virus H5N1VAH-certifi ed

STAMMOPUR R Phosphate-free concentrate for cleaning instrumentsMildly alkaline, pH 9.6 (1%)Application 2%

STAMMOPUR GR Acidic concentrate for basic instrument cleaningpH 1.9 (1%)Application 5% at 50-60°CRemoves lime residues, metal oxides and temper colours from medical instruments.Only use in plastic insert tubs.

Further information on the STAMMOPUR concentrates can be found in the EC safety data sheets and the product leafl ets.

See Appendix A for dosage information.

If service is required, please contact your specialist dealer or write to us at the address provided.

8 Consumable materials - not applicable -

9 Decommissioning

If the ultrasound no longer works, it must be appropriately disposed of.

10 Key words - not applicable -

BANDELIN electronic GmbH & Co. KGHeinrichstraße 3 – 4 12207 BerlinDeutschland

[email protected] +49 30 768 80-0 +49 30 773 46 99

Zertifi ziert nachISO 9001 ISO 13485

A Dosing and application instructions for STAMMOPUR agents

Disinfection and intensive cleaning Cleaning Basic cleaning

Directly in the oscillating tank Indirectly in the insert tub

STAMMOPUR

DR 8

2%

STAMMOPUR

R

2%

STAMMOPUR

GR

5%Disinfection and cleaning time min 5 3 – 10 2 – 15

Temperature of use °C max. 40 20 – 60 50 – 60

TE 1031 / TE 1032

Fill quantity up to mark l 20.0 20.0 15.0 *

Concentrate ml 400 400 750

Water l 19.6 19.6 14.2

TE 1058 / TE 1059

Fill quantity up to mark l 32.0 32.0 15.0 *

Concentrate ml 640 640 750

Water l 31.3 31.4 14.2

Order information

Order No. 2 l 972 934 938

Order No. 5 l 974 989 969

Order No. 25 l 936 976 970

Order No. 200 l – 966 971

/* Recommended fi ll quantity in the plastic insert tub = Until the tub stops fl oating in the oscillating tank's contact fl uid. When doing so, ensure that the items to be cleaned are completely covered with bath fl uid in the tub.

Please follow the product information and instructions for use, dosing and exposure of the cleaning agents used.

Foil testTesting of ultrasonic baths

Information

A foil test1 is recommended for testing ultrasonic baths. It is

to be conducted upon initial startup, and at regular intervals

thereafter (e.g. every 3 months). The frequency of testing is the

responsibility of the user.

The foil test is a simple procedure to demonstrate the intensity

and distribution of cavitation in an ultrasonic bath. To do so,

aluminium foil is stretched over a foil test frame. It is perfo-

rated or destroyed to a certain degree by cavitation, depending

on the duration.

For purposes of reproducibility, it is important that the test conditions remain constant:

• Fill level in the oscillating tank (² )

• Temperature of tank contents

• Degassing time, if needed (degassing 5 to 30 min. before

the test, depending on the tank contents)

Time may need to be extended with acidic cleaning solu-

tions.

• Frame positioning

• Foil properties (thickness, surface)

• Sonication time

• Concentration and type of ultrasound preparation

Foils can be archived in a suitable way (scanning, photos, etc.)

This allows the foils to be compared at any time. The perfo-

rated areas of all foils should have approx. the same

dimensions and distribution – the results are never identical.

A process validation, e.g. for the treatment of medical products,

can only be achieved by conducting regular foil tests.

To execute the foil test, different foil test frames FT can be

ordered from the manufacturer (for a fee). The foil test frames

are suitable for a wide range of tank dimensions. Aluminium

household foil is also required to conduct the test and is not

included in the delivery.

Film: http://bandelin.com/folientest/.

1 Investigations on test procedures for ultrasonic cleaners. IEC/TR 60886 (1987-03)

Fluid for the foil test

In order to obtain an adequately strong cavitation effect, the

surface tension of the water used must also be reduced for the

foil test with the help of surfactant preparations. We recom-

mend the following ultrasound preparations:

STAMMOPUR DR 8, STAMMOPUR R, TICKOMED 1,

TICKOPUR R 33, TICKOPUR R 30, TICKOPUR TR 7

If none of these preparations is available, a neutral or mildly

alkaline preparation that does not destroy aluminium may be

used. The preparation must be approved by the manufacturer

for use in ultrasonic baths.

939x GB/2018-09 1 / 2

Example

B Foil test

Conducting the foil test 1. Fill 2/3 of the oscillating tank with water and a suitable

ultrasound preparation in the dosage specified by the man-ufacturer.

2. Degas the liquid: < 10 l - 10 min and > 10 l - 30 min(see user instructions.)

3. Stretch aluminium foil (household foil with a thickness of 10 m to 25 m) over the wire frame (stainless steel). Depending on the tank size, it is possible that the frame protrudes from the tank. Covering the portion of the frame that is submerged will suffice.

939x GB/2018-09

BANDELIN electronic GmbH & Co. KGHeinrichstraße 3–412207 BerlinDeutschland

[email protected]

+ 49 30 768 80 - 0 + 49 30 773 46 99

Zertifiziert nachISO 9001ISO 13485

5. Switch on the ultrasound and sonicate the foil for at least one minute until visible perforations or holes are produced. With sturdier foils (thicker or coated ones), the sonication time can last up to 3 minutes.

6. Switch off the ultrasound, take the foil out and let it dry.

7. The foil must be perforated, otherwise contact the manu-facturer.

Type

for interior tank dimensions in mm (L x W x H)

Order No. forfrom to

FT 1 190 × 85 × 60 3190DT 31/H, DT 52/HRK 31/H, RK 52/H

FT 4 240 × 140 × 80 300 × 150 × 150 3074

DL 102 H, DL 255 H, DT 100/H, DT 102H/H-RC, DT 103, DT 106, DT 255/H/H-RC, RK 100/H, RK 102 H, RK 103, RK 106, RK 255/H

FT 6 500 × 140 × 100 500 × 140 × 150 3222DL 156 BH, DT 156/BH, DT 1028 FRK 156/BH

FT 14 280 × 234 × 80 325 × 300 × 300 3084

DL 510 H, DL 512 H, DL 514 BH, DT 510/H/H-RC, DT 512 H, DT 514H/BH/BH-RC, RK 510/H, RK 512 H, RK 514/H/BH, ZE 514/...DT

FT 36 510 × 300 × 200/220 3673 ZE 1031/1032/...DT

FT 37 600 × 400 × 200/220 3674 DT 1058 M, ZE 1058/1059/...DT

FT 38 650 × 400 × 140/160 3672 MC 1001/E

FT 40 500 × 300 × 80 500 × 300 × 300 3094DL 1028 H, DT 1028/H/CH, RK 170 H, RK 1028/H/C/CH, RK 1040

FT 42 700 × 420 × 160/190 3224 TRISON (TE 3000)

FT 45 600 × 400 × 200 600 × 400 × 200 3204DT 1050 CH, RK 1050/CH

2 / 2

Frame Ø 3 mm

Aluminium foil, folded 10mm along the edge

4. With the ultrasound switched off, place the foil-wrapped wire frame diagonally inside the oscillating tank, adjust if necessary.

8. Archive it together with testing date and the serial number of the ultrasonic bath.

9. After the test, the oscillating tank must be thoroughly rinsed out to remove any loose foil particles.

Please note:The user instructions in this and other languages, as well as further information, can be found on the enclosed CD.

user instructions - bandelin · user instructions 3 ze built-in ultrasonic baths valid for: ze 1031...

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