User instructions. 3 ZE built-in ultrasonic baths and B standards for aqueous fluids. valid for: ZE 1031 ZE 1032 ZE 1058 ZE 1059 ZE 3000

Transcription

1 User instructions 3 ZE built-in ultrasonic baths and B standards for aqueous fluids Installation example Control unit ST 15.1 or Control unit ST 30 DT valid for: ZE 1031 ZE 1032 ZE 1058 ZE 1059 ZE 3000 ZE 1031 DT ZE 1032 DT ZE 1058 DT ZE 1059 DT ZE 3000 DT SONOBOARD Standard 6386d GB/

2 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 GmbH & Co. KG, Heinrichstraße 3 4, Berlin, Germany Tel.: , Fax: , info@bandelin.com 2 / d GB/

3 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 Danger Caution Used to mark information that, if not observed, could constitute a risk to life and limb, especially as a result of electric shock. 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 Instructions Do not dispose of device in the waste bin - proper disposal is required! For health reasons, remaining for long periods of time in the vicinity of the device without hearing protection is prohibited. Identifi es instructions that must be followed in the described sequence. Pursuant to European directive 2012/19 EU (WEEE), old electronic units must be disposed of through the regulatory agencies designated for this purpose, separately from household waste. Additional information is available from your local municipality or waste disposal agency. 6386d GB/ / 40

4 Table of Contents 1 Product description Mode of operation Purpose CE conformity Technical data Degrees of protection Electromagnetic compatibility (EMC) Warnings and safety precautions Preparation Scope of delivery Set-up / assembly Start-up Operation Control elements of the ST Ultrasound Miscellaneous functions - not applicable Control elements of the ST 30 DT Ultrasound Special functions of the ST 30 DT Ultrasonic bath signals - not applicable Use Instructions for use General application Treatment of medical and dental instruments Further information Degassing / d GB/

5 4.4.2 Disposal of sonication fl uids Cleaning and maintenance of the ultrasonic bath Cleaning and care Disinfection Positioning / Storage Maintenance and repair Maintenance Function test / functional check Error analysis Repairs and service Decontamination certificate Accessories Required accessories Optional accessories Preparations Consumable materials - not applicable Decommissioning Key words - not applicable Informative annexes A B C Dosing and application instructions for STAMMOPUR agents Foil test Decontamination - sample copy 6386d GB/ / 40

6 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 high-quality PZT high-performance ultrasound system 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 and continuous operation (4) Separate HF 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) SONOREX ZE SONOREX ZE 1031 DT Back of HF generator example: Upright or hanging HF generator / d GB/

7 SONOBOARD Standard functional cabinet 1 4 (ST 30 DT) 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 field in the bath volume for constantly reproducible results. 6386d GB/ / 40

8 1.2 Purpose General use SONOREX 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 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 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 : / d GB/

9 1.4 Technical data SONOREX ZE ultrasonic baths are interference-free and marked with a CE. Safety: EN ; EMC: EN Ultrasonic TE oscillating tank, SW rinsing tank - 2 m cable with AMP-CPC connector - Degree of protection: IP 30 pursuant to DIN EN (see Chapter 1.4.1) Ultrasonic bath ZE 1031 /DT ZE 1032 /DT ZE 1058 /DT ZE 1059 /DT Model Materials Interior dimensions (LxWxD) mm Capacity (L) Outlet Exterior dimensions (LxWxH) mm TE 1031 Stainless /290 steel, 2 mm, / Bead 1½" SW 31 Z welded /225 TE 1032 Stainless /290 steel, 2 mm, / Bead 1½" SW 31 Z welded /225 TE Stainless /290 steel, 2 mm, / Bead 1½" SW 58 Z welded /225 TE 1059 Stainless /290 steel, 2 mm, / Bead 1½" SW 58 Z welded /225 HF generator - Operating voltage: 230 V~ (± 10 %) 50/60 Hz - Ultrasound frequency: 35 khz - Fuse: F2A - IP class: IP 20 pursuant to DIN EN (see Chapter 1.4.1) Ultrasonic bath Model Ultrasonic peak power W Rated ultrasonic output W Current consumption A External dimensions (L W H) mm ZE 1031 /DT GT 503 M-C ZE 1032 /DT GT 504 M-C ZE 1058 /DT GT 1003 M-C ZE 1059 /DT GT 1003 M-C 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. 6386d GB/ / 40

10 Control unit ST Mechanical timer, 1 to 15 mins and continuous operation - Fuse: G 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 HF generator. - Degree of protection: IP 30 pursuant to DIN EN (see Chapter 1.4.1) Control unit ST 30 DT - Digital timer, 1 to 30 mins and continuous operation - Fuse: 2x - G 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 HF generator. - Approx. 2 m data cable with connector for connection to the temperature sensor. - Degree of protection: IP 30 pursuant to DIN EN (see Chapter 1.4.1) Ambient conditions pursuant to EN Overvoltage category: II Degree of soiling: 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 allowed. For indoor operation only. Specifications for use as a medical device Name: Ultrasonic bath UMDNS nomenclature (ECRI / DIMDI): Purpose: See chapter 1.2. Classifi cation (in acc. with Directive 93/42/EEC, Appendix IX): Class I; active, non-invasive, nonimplantable medical device Type, 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 Specifications pursuant to the German Medical Devices Operator Ordinance (MPBetreibV): Start-up on location, functional check and personnel training (section 5): Technical safety controls, (STK, section 6): Technical measurement controls, (MTK, section 11): not required no specifi cations not applicable 10 / d GB/

11 Specifications as per DIN EN / VDE 0750 Part 1 / IEC 601-1: Protection class: I Protection class (B, BF, CF): Not applicable, as no application part present Degrees of protection IP 20 pursuant to DIN EN Protected against access by fi ngers to hazardous parts; protected against solid foreign bodies with a diameter of 12 mm or larger No protection against the penetration of water IP 30 pursuant to DIN EN 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 Electromagnetic compatibility (EMC) The device has been checked for electromagnetic compatibility in accordance with DIN EN and meets the requirements for Class B devices in accordance with EN 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. 6386d GB/ / 40

12 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 HF 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 fluid 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. 12 / d GB/

13 Advice for the medical field The ultrasonic bath is exclusively intended for use by skilled medical personnel. 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. 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. 6386d GB/ / 40

14 2.1 Scope of delivery 1 Ultrasonic oscillating tank 1 HF generator with bracket for vertical installation 1 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 HF 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. SONOBOARD Once 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. 14 / d GB/

15 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 Green control light (Ultrasound in operation) 2 Turning knob for Ultrasound ON / OFF with preset time 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 Miscellaneous functions - not applicable d GB/ / 40

16 3.2 Control elements of the ST 30 DT 4 1 Ultrasonic bath ON/OFF button 2 Preset time button 3 Start/Stop button Ultrasound 4 LEDs for temperature and time 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. 16 / d GB/

17 3.2.2 Special functions of the ST 30 DT Temperature scale: Display accuracy: ± 2.5 C. 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. Time scale / 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 firstly 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. 3.3 Ultrasonic bath signals - not applicable d GB/ / 40

18 4 Use Direct sonication Normally, 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. Basket holder with basket Sonication fl uid 4.1 Instructions for use Instructions - filling 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. 18 / d GB/

19 Notes - Temperature Warmed-up fl uids intensify the ultrasound effect. Experience has shown that the best results are obtained with a bath temperature of 50 to 60 C. At high temperatures, the effi ciency of the ultrasound cavitation decreases again 2. 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 MILLNER, R.: Wissenspeicher Ultraschalltechnik, Fachbuchverlag publishing house, Leipzig d GB/ / 40

20 4.2 General application Step 1: Fill oscillating tank The 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 fluid Freshly-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 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 min Time may need to be extended with acidic cleaning solutions. Step 3: Insert objects to be treated Before 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. Oscillating tank with basket holder 2/3 For cleaning tasks Place 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. 20 / d GB/

21 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 operation Fundamentally, 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 objects After 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 specifications of the preparation manufacturer. If necessary, empty the oscillating tank. Step 6: Empty the oscillating tank Layers 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 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 d GB/ / 40

22 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 3. 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). 3 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 : / d GB/

23 4.4 Further information Degassing The degassing of the sonication fl uid increases the ultrasound effect. Freshly filled-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 fluid (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 signifies the end of the degassing process and an improvement in the ultrasound effect Disposal of sonication fluids 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 may be added to sewerage as bath fluids, see Chapter 7.3. Disinfecting 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 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. 6386d GB/ / 40

24 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 / HF generator from the mains before cleaning / maintenance. Do not rinse or immerse the ultrasonic bath and HF generator in water and do not expose them to splash water. The guarantee will not apply to damages caused by the use of unsuitable disinfecting agents or detergents. 5.1 Cleaning and care Oscillating tank The 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. HF 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. 24 / d GB/

25 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. 6386d GB/ / 40

26 6.2 Function test / functional check Check the control light on the ST 15.1 Pursuant to Chapter 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: (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? See Chapter 4.2 / Step 2 : Degassing the fl uid. - Is it overloaded with objects to be treated? - Uneven noises (wobbling) 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. 26 / d GB/

27 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. KG Heinrichstraße Berlin Germany Repair service: Tel.: +49-(0) Fax: +49-(0) 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 rectified by repairs performed by the manufacturer, the entire unit must be sent in for repairs (oscillating tank, user unit and generator). 6.5 Decontamination certificate 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: - Downloads... A sample copy can be found in the appendix. 6386d GB/ / 40

28 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) 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, (ISO baskets) ZE /DT: 1058, / d GB/

29 Stainless steel basket holders, - load capacity up to 10 kg KT 30, KT 57 KT 30 Z, KT 57 Z Model Order no. Suitable for ultrasonic bath Exterior dimensions (L W H) mm KT 30 (= 1/1 DIN) 056 ZE /DT: 1031, KT 57 (= 1/1 DIN + ISO) 061 ZE /DT: 1058, KT 30 Z (= 1/1 DIN) 077 ZE /DT: 1031, KT 57 Z (= 1/1 DIN) 3078 ZE /DT: 1058, 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 ZE /DT: 1031, 1032 D ZE /DT: 1058, 1059 D 1058 G* 3232 ZE /DT: 1058, 1059 * Hinged lid with gas spring and EPDM profi le seal. 6386d GB/ / 40

30 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 ZE /DT: 1031, 1032, 1058, 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 FE 12 fi xed in basket 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 ZE /DT: 1031, 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 ultrasoundcompatible, 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) / d GB/

31 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 STAMMOPUR R STAMMOPUR GR 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 H5N1 VAH-certifi ed Phosphate-free concentrate for cleaning instruments Mildly alkaline, ph 9.6 (1%) Application 2% Acidic concentrate for basic instrument cleaning ph 1.9 (1%) Application 5% at C Removes 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. 6386d GB/ / 40

32 8 Consumable materials - not applicable - 9 Decommissioning If the ultrasound no longer works, it must be appropriately disposed of. Some electrical components are considered to be toxic waste. 10 Key words - not applicable - If service is required, please contact your specialist dealer or write to us at the address provided. BANDELIN electronic GmbH & Co. KG Heinrichstraße Berlin Deutschland info@bandelin.com Zertifi ziert nach EN ISO 9001:2008 EN ISO 13485:2012

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35 A Dosing and application instructions for STAMMOPUR agents Disinfection and intensive cleaning Cleaning Directly in the oscillating tank STAMMOPUR DR 8 STAMMOPUR R Basic cleaning Indirectly in the insert tub STAMMOPUR GR 2% 2% 5% Disinfection and cleaning time min Temperature of use C max TE 1031 / TE 1032 Fill quantity up to mark l * Concentrate ml Water l TE 1058 / TE 1059 Fill quantity up to mark l * Concentrate ml Water l Order information Order No. 2 l Order No. 5 l Order No. 25 l Order No. 200 l * 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.

36 B Foil test Information Foil test Testing of ultrasonic baths A foil test 1 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 perforated 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 ) 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 recommend 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. 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 solutions. 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 perforated 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 ( ) 939w GB/ / 2

37 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 manufacturer. 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. Frame Ø 3 mm 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 manufacturer. 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. for interior tank dimensions in mm (L x W x H) Type from to Order No. FT FT FT FT for DT 31/H, DT 52/H RK 31/H, RK 52/H 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 DL 156 BH, DT 156/BH, DT 1028 F RK 156/BH 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 / ZE 1031/1032/...DT FT / ZE 1058/1059/...DT FT / MC 1001/E FT FT / TRISON (TE 3000) FT DL 1028 H, DT 1028/H/CH, RK 170 H, RK 1028/H/C/CH, RK 1040 DT 1050 CH, RK 1050/CH 939w GB/ BANDELIN electronic GmbH & Co. KG Heinrichstraße Berlin Deutschland info@bandelin.com Zertifiziert nach EN ISO 9001 EN ISO / 2