Instructions for Use S / SONOBOARD. Ultrasonic bath. for MIS and standard instruments

Transcription

1 Instructions for Use S / SONOBOARD Ultrasonic bath for MIS and standard instruments Ultrasonic bath MC 1001 Built-in ultrasonic bath MC 1001 E Valid for all SONOMIC ultrasonic baths and SONOBOARD FS 1200 ML/MR with software versions starting at 1.5x and serial numbers starting at xxxx yyy. 6376d GB/

2 Copyright & limit 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. Liability for indirect or direct damage arising because of incomplete or erroneous information in this documentation, as well as its delivery and usage, is excluded GmbH & Co. KG, Heinrichstrasse 3 4, Berlin, Germany Phone: , Fax: , info@bandelin.com 2 / d GB/

3 General The equipment, the accessories and the preparations are to be used in accordance with the user instructions and/or the product information. The instructions are part of the scope of delivery and are to be stored in the vicinity of the device for later reference. This also applies if possession of the device is transferred elsewhere. Before the device is put into operation, these Instructions for Use should be read carefully and completely in order for the user to become familiarised with all functions. The warnings and safety precautions (section 1.7) are always to be followed during use. The manufacturer will not assume any responsibility for the device's safety or functional ability in the event of improper handling or usage contrary to the intended purpose. In the event of unauthorised alterations/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 Significance Explanation Danger Caution Important Identifi es information that could signify a risk to life and limb, especially through electric shock, if not observed. Identifi es information that is to be observed and adhered to without fail in order to prevent damage to the device and the user. When device parts are labelled with this symbol, the documentation must be referred to. Identifi es information that is important for execution. Note Identifi es information provided for explanatory purposes. 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 ear protectors 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. 6376d GB/ / 62

4 Table of Contents 1 Product description Functional cabinet SONOBOARD FS 1200 ML/MR Mode of operation Purpose CE conformity Technical data Electromagnetic ambient conditions (EMC) Interfaces SONOBOARD functional cabinet Warnings and safety precautions Preparation Scope of delivery Set-up / assembly Start-up Operation Operating elements Signals on the ultrasonic bath Connection and removal of the instruments Connecting / removing the adapter testing stripes Opening and closing the outlet Use Preparation of the ultrasonic bath Treatment of instruments Mode Mode Mode Post-processing of the ultrasonic bath Cleaning and maintenance of the ultrasonic bath Cleaning and care Disinfection / d GB/

5 5.3 Warehousing / storage Maintenance and repair Maintenance Changing the filter Replacing the adapter seal Functional check Malfunction / Fault analysis Repairs and service Decontamination certificate Replacing fuses Determining information on software version and report data Accessories Required accessories Optional accessories Lid Silicone knob mat Chemical agents STAMMOPUR DR 8 Disinfection and cleaning agent STAMMOPUR R Instrument cleaner Consumable materials Taking the unit out of service Key words - not applicable Informative appendices A B C Foil test Decontamination - sample copy Service lists D Screenshots with explanations starting with version 1.5x 6376d GB/ / 62

6 1 Product description SONOMIC ultrasonic bath with rinsing function for MIS instruments. The SONOMIC is available as a compact or built-in ultrasonic bath. The exact type specifi cations and serial number can be found on the type plate. SONOMIC ultrasonic bath is also available as a SONOBOARD ready-to-use set in a functional cabinet. In the following, the term SONOMIC ultrasonic bath is used for both variants. Product features for compact ultrasonic bath MC 1001: Stainless steel oscillating tank (1) with high-grade PZT high-performance ultrasonic systems, ultrasound frequency 40 khz. For additional details, see page 8. Compact, easy-to-clean stainless steel housing (2) Operating panel with touchscreen (3) Special basket (4) with adapters for the fastening of instruments. For additional details, see page 8. Outlet (5) with ball valve (5a) for easy draining of the bath fl uid Diverse interfaces (6) for record-keeping Maintenance cover (7) Mains cable (8) mains switch (9) Rubber feet for safe positioning (10) Front view 5a Rear view 6 / d GB/

7 Product features for built-in ultrasonic bath MC 1001 E: Stainless steel oscillating tank (1) with high-grade PZT high-performance ultrasonic systems, ultrasound frequency 40 khz. For additional details, see page 8. Separate HF generator with rinsing module for hanging in the oscillating tank (2a) Separate control unit with operating panel (3) - swivelling, with touchscreen Special basket (4) with adapters for the fastening of instruments. For additional details, see page 8. Outlet (5) with drain set (5b) for fast draining of the bath fl uid Diverse interfaces (6) for record-keeping Connections for the oscillating tank and heating (7a) Cold device socket (8a) for mains connection, connections for control unit (8b), mains switch (9) 3 9 (rear side) / 5b 2a 6 7a Front view 8b 5 / 5b 8a Rear view 6376d GB/ / 62

8 Details of the oscillating tank Filling level mark for safe fi lling (11) Basket mounts (12) for special basket (13) with comb bar (13a) and handles (13b) 12 adapters (14) to connect the instruments Labelled connector sockets (15 and 15a) for channels 1-12 Fluid sensors for process control - temperature sensor (16a) and fi ll level sensor (16b) Exchangeable fi lter (17) for reception of cast-off contamination Return fl ow opening (18) for return transport into the oscillating tank 13a 12 13b a a b 17 8 / d GB/

9 1.1 Functional cabinet SONOBOARD FS 1200 ML/MR The SONOBOARD functional cabinet is available in both right- and left-handed variants, as indicated by the letters "R" or "L" in the type designation. Product features: Stable, easy-care stainless steel carcass (1) Easy-care stainless steel work surface with upstand (2) Double-walled doors (3) Easy-run swivel-casters (4), with locking brakes at the front Slot for utility connections in rear wall d GB/ / 62

10 1.2 Mode of operation Principle of ultrasonic cleaning SONOMIC ultrasonic baths use the effect of cavitation. Under the bottom of the tank they contain piezoelectric transducers, the energy of which is transferred to the bath fl uid as mechanical oscillations with ultrasound frequency. As a result, microscopically small bubbles are continuously formed in the bath fl uid, which release energy upon imploding and generate local microcurrents. This process is called cavitation. During the cleaning process, it causes contamination to be positively blasted from the hard surfaces of the objects being treated. At the same time, dirt particles are dispersed and fresh bath fl uid fl ows in. During sonochemical processes, cavitation can have a catalytic effect, e.g. with the use of cleaning agents and disinfectants that are suitable for use with ultrasound. SONOMIC ultrasonic baths are effi ciently supported by SweepTec automatic frequency control. SweepTec immediately balances load-dependent working point fluctuations to the optimal working point using fast frequency modulation. This produces an especially homogeneous and uniform ultrasound fi eld in the bath volume for constantly reproducible results. Rinsing of MIS instruments / cleaning of standard instruments During sonication, up to 12 rinsable MIS instruments with exterior diameters of 1-10 mm can be rinsed from the inside in the SONOMIC. Each instrument is connected to an assigned adapter and linked to the rinsing cycle. Rinsing is conducted using a suction process at the distal end of the instruments. Soiling is always evacuated in the opposite direction to which it entered. The remaining lumen of the instruments is not contaminated any further by this soiling. The interior of the shaft of every instrument is rinsed and tested individually for fl ow-through. Instruments that were not rinsable during the cleaning process, e.g. due to clogging, are securely identifi ed by the integrated patency test and specifi ed on the monitor. "Non-patency" of an instrument is declared when the fl ow-through rate is less than 2 ml/s. Non-rinsable standard instruments such as scissors and forceps are placed in the special basket or a similar basket and are not connected to the adapters the adapters remain open. The ultrasound disinfection and cleaning cycle per instrument is programmed for a total treatment time of 5 min using a disinfecting preparation suitable for use with ultrasound. 10 / d GB/

11 Functional diagram: Adapters Instrument 1 Oscillating tank Instrument 12 Channel selector Pump P Pressure switch Filter Flow rate sensor 1.3 Purpose SONOMIC ultrasonic baths are used to treat hollow medical instruments. In this connection, they are to be used together with suitable, non-fixative disinfection and/or cleaning agents in order to support or expedite their effect. Hence, as accessories to medical devices pursuant to section 2 para. 1 and section 3 paras. 1, 9 and 10 of the German Medical Devices Act (MPG), according to purpose, SONOMIC ultrasonic baths are to be treated as medical devices themselves. Non-rinsable medical instruments can also be disinfected and simultaneously cleaned with the SONOMIC ultrasonic bath. They are placed in the basket and not connected to the adapters the adapters then remain open. If the SONOMIC ultrasonic bath is used together with a cleaning preparation that has no disinfecting properties, the instruments must be additionally disinfected at the end of cleaning. Caution! The use of the SONOMIC ultrasonic bath does not absolve users from conducting a subsequent thorough flushing, drying, functional check and sterilisation, or fi nal disinfection of the instruments, pursuant to KRINKO recommendations 1 or other regulations in effect in the respective country. Caution! The use of chemically aggressive fl uids (e.g., using acids as cleaning agents) the removal of chemically aggressive soiling (e.g. cleaning of developing machine racks) and the removal of abrasive contamination (e.g. polishing pastes, quartz, sand) in the ultrasonic baths is strictly prohibited. 1 Recommendation of the 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/ / 62

12 1.4 CE conformity SONOMIC ultrasonic baths are declared as medical devices and satisfy the CE marking criteria for the following European directives: - Medical Device 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. 1.5 Technical data SONOMIC ultrasonic baths are interference-free and CE - marked. Safety: EN , EMC: EN Stainless steel material: Exterior dimensions (L W H): without lid and outlet Ultrasonic bath MC 1001 Oscillating tank , 2 mm Jacket Built-in ultrasonic bath MC 1001 E Oscillating tank , 2 mm User unit mm mm Interior dimensions (LxWxD): /170 mm /170 mm Usable interior dimensions: (basket) Weight: 45 kg (with basket and lid) 80 kg (fi lled with liquid) mm 40 kg (with basket and lid) 70 kg (fi lled with liquid) Contents: 42.5 l 43.5 l Operating volume: (fi lling level mark) Outlet: On the inside: Outlet ¾", ball valve On the outside: Threaded nipple G ¾ 27.0 l 27.5 l G 1½ fi tting, with turning knob and stainless steel plugs Degree of protection: IP 20 - see below - Mains supply: Heating power: (maintenance heating) Frequency: Ultrasonic peak power: 230 V~ (± 10 %) 50/60 Hz, cable length 2 m (115 V on request) 400 W 40 khz 2400 W Ultrasonic nominal output: 600 W* Power consumption (230 V), max.: Max. power consumption 3 A 680 W 12 / d GB/

13 Fuses: board Energy consumption: Relay circuit Generator circuit board Monitored temperature range Interfaces for protocol output Ultrasonic bath MC F 3.15 A each 2 F 4 A 1.49 kwh** C Built-in ultrasonic bath MC 1001 E parallel and serial for connection to a receipt printer or PC * In order to improve the effect, the ultrasound is modulated, resulting in a 4-fold ultrasonic nominal output value as ultrasonic peak power. ** 10 cycles, incl. preparation and post-processing More detailed information regarding the degree of protection pursuant to DIN EN 60529: Protected against access with fingers to dangerous parts Protected against solid foreign bodies with a diameter of 12 mm or larger Not protected against ingress of water. Environmental conditions pursuant to EN Overvoltage category: II Degree of contamination: 2 Permissible ambient temperature: 15 to 35 C Permissible relative humidity up to 31 C: 80 % Permissible relative humidity up to 40 C: 50 % Altitude: up to 2000 m No condensation allowed. Only for indoor operation. 6376d GB/ / 62

14 Specifications for use as a medical device Name: Ultrasonic bath UMDNS nomenclature (ECRI / DIMDI): Purpose: see chapter 1.3. Classifi cation (pursuant to Medical Device Directive 93/42/EEC, Annex IX): Type, model, serial number, year of manufacture: Class I; active, non-invasive, nonimplantable medical device See type plate on the rear side for information The ultrasonic bath has been inspected pursuant to norms currently in effect and is to be installed and put into operation pursuant to EMC directions. Relevant information can be found in the appendix. Specifications pursuant to the German Medical Devices Operator Ordinance (MPBetreibV): Start-up on location, functional check and personnel training (section 5): not required Technical safety controls, (STK) (section 6): Every 2 years by the manufacturer or authorised skilled personnel (DIN EN / VDE 0750) Technical measurement controls (MTK) (section 11): not applicable Specifications as per DIN EN / VDE 0750 Part 1 / IEC 601-1: Protection class: I Electromagnetic ambient conditions (EMC) The device was tested to DIN EN for electromagnetic compatibility (EMC) and complies with the requirements for class B devices according to EN It is suitable for use in facilities and areas which are directly connected to a public lowvoltage supply network, e.g. medical laboratory facilities. 14 / d GB/

15 1.5.2 Interfaces There are three data interfaces available on the ultrasonic bath MC 1001 on the righthand side, and on the built-in ultrasonic bath MC 1001 E on the front side of the HF generator, for issuance of a treatment protocol. Parallel interface The parallel and RS 232 interfaces are designed for direct connection to a receipt printer. A PC is preferably connected to the RS 232 interface or to the USB interface. After treatment, the same data is found on all three interfaces, including: Description, serial number Cycle counter Bath temperature Result of the treatment mode USB interface RS232- interface It is possible to use the interfaces simultaneously. The devices, cables and PC programs required for communication are not part of the scope of delivery and are the user's responsibility. The manufacturer only guarantees the proper functioning of the interfaces. Note: Detailed information regarding the interfaces, protocol and connection assignment of usable cables and printers can be obtained from the manufacturer, upon request, in German or English. 1.6 SONOBOARD functional cabinet Type: FS 1200 MR / ML External dimensions, including casters (LxWxH): mm Material: Stainless steel Weight, complete*: 190 kg * Functional cabinet including MC 1001 E 6376d GB/ / 62

16 1.7 Warnings and safety precautions General Keep the ultrasonic bath out of the reach of children and of persons who have not been instructed in its operation by reference to these instructions. We do not offer any guarantee for damage to the ultrasonic bath or oscillating tank, or to the objects to be treated, resulting from use of inadequate disinfection agents or detergents. Keep the surface of the ultrasonic bath and operating elements clean and dry. Do not expose the ultrasonic bath to corrosive infl uences. Only move the ultrasonic bath / SONOBOARD when it is empty. Empty the ultrasonic bath only when prompted by the operating program. Accessories (SONOMIC basket, adapter, etc.) not suitable for thermal disinfection/ sterilisation due to the materials used. Ultrasonic baths adhere to prescribed EMC limit values, so it can be assumed that the electromagnetic radiation emanating from the units is harmless to humans. However, 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 is to be obtained from the implant manufacturer. Operation Observe ambient and set-up conditions, see chapter 1.5. Never operate the ultrasonic bath without the cover for the transducers (MC 1001 E) or the base plate (MC 1001)! In the case of built-in unit MC 1001 E, only turn on the HF generator if the oscillating tank is connected (HF cable) never run the generator without a load. Only plug in the ultrasonic bath to an outlet with a grounded socket. Do not operate the ultrasonic bath without fl uids. Do not fi ll oscillating tank with hot water (> 40 C). The fi lling temperature should be between 18 and 25 C. Do not use a rubber plug or stand pipe on the oscillating tank's outlet! Do not stand or lay any objects on the tank bottom, accessories must be used, see chapter 7. Do not immerse any parts of the body (e.g. hands, feet) or living organisms (animals or plants) in the tank; in particular, do not immerse them in the bath liquid 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 impairment possible during operation if not wearing hearing protection the typical ultrasound cavitation noise can be very uncomfortable. Do not leave the ultrasonic bath unattended while in operation. Fully replace used fl uids, do not refresh them by adding more fl uids. Follow the manufacturer's dosage instructions. 16 / d GB/

17 Advice for the medical field The ultrasonic bath is exclusively intended for use by skilled medical personnel. It may generate radio interferences or disrupt the operation of devices nearby. It may be necessary to take remedial measures such as realigning the device or 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, adhere to the relevant personnel protection regulations (e.g. protective clothing, protective goggles, appropriate gloves). When treating instruments, follow the instructions of the instrument manufacturer. Ultrasound cleaning is especially suited for instruments made of stainless steel and hard plastics. Do not treat lenses, camera systems or light cables with ultrasound. A combined disinfection and cleaning of medical instruments in the ultrasonic bath is only possible with the use of special preparations (with the corresponding microbiology certifi cates). Ultrasound alone will not disinfect them! Operate the ultrasonic bath with a lid, or below / above a suctioning system. 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 power plug immediately. Repairs must only be conducted by authorised skilled personnel or by the manufacturer. Defective parts may only be replaced with original parts. 6376d GB/ / 62

18 2 Preparation Carefully unpack the ultrasonic bath and accessories and inspect them for completeness or possible transportation damage. If any damage or defects are found, these must be immediately notifi ed in writing to the transportation company and to the supplier. Before startup, the ultrasonic bath is to be left to stand at its operating location for 2 hours so that it may adapt to the ambient conditions. 2.1 Scope of delivery 1 Ultrasonic bath, cf. table 1 Instruction manual Additional accessories according to order - see delivery note Component Ultrasonic bath MC 1001 Built-in ultrasonic bath MC 1001 E Name Order No. Name Order No. Complete unit MC MC 1001 E 3345 Oscillating tank built-in TE 1001 E 3371 HF generator with rinsing module built-in GT 1001 E 3370 Control unit built-in ST 1001 E Adapter (complete with seal and hose) 12 ADS ADS Basket K 1001 MC 3324 K 1001 MC 3324 Adapter testing stripes 2 APB APB Reducer G 1 on G ¾ - Elbow hose screw connection G 1 with seal - Hose (made of PVC) 19 mm, 1 m long - Mains cable fi rm loosely enclosed Cable ties 2 3 Outlet - Ball valve ¾ built-in A 017 A 140 Drain set G 1½ partially pre-mounted Filter cartridges 30 EF EF Adapter seals 12 AD AD Assembly chips 5 enclosed enclosed 18 / d GB/

19 2.2 Set-up / assembly Ultrasonic bath MC 1001 Ensure: Set ultrasonic bath on a dry and level work plate. 15 cm 15 cm Take note of the total weight (80 kg fi lled). Observe minimum distances when setting up, see enclosed diagram. Observe electromagnetic environmental conditions pursuant to chapter 1.5. Connect enclosed hose with the outlet nipple of the ultrasonic bath. To do so, wrap the enclosed sealing tape around the threaded nipple multiple times (approx. 10x), toward the right, then screw on the reducer. While tightening the elbow hose screw connection, hold the reducer fi rmly in place using a spanner (SW 36). Do not back off the reducer by screwing it toward the left, as doing so will destroy the sealing action of the sealing tape. Lay the sloped hose end loosely for draining. A fi xed installation must be conducted by an installer. 10 cm Built-in ultrasonic bath MC 1001 E The installation of the built-in ultrasonic bath must be conducted by authorised skilled personnel, under reference to the 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. Note: The control unit can be pivoted out of the functional cabinet. When planning the installation, at least 250 mm must be allowed in addition to the external dimension. 6376d GB/ / 62

20 2.3 Start-up Thoroughly rinse the ultrasonic bath's oscillating tank with water before its fi rst use. Plug in the mains plug in an earthed power outlet. Connect the ultrasonic bath to the mains switch for testing. If the operating panel lights up, the connection is correct. Set the desired language on the welcome screen. Switch the ultrasonic bath off 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 chapter 6.2. Insert the basket in the oscillating tank (comb bar on the left). If the adapter with hoses is not yet connected, please connect. Note: First connect the lower row of adapters. Next, put on the lid or close the hinged lid. 3 Operation 3.1 Operating elements Operation is conducted through the operating panel, on a touchscreen. The operating program will guide you with clear instructions through the individual steps. See appendix D for an overview of the operating program. Status bar Progress bars Instruction(s) Help key Confi rmation key Back key Instructions are to be carried out from top to bottom. Once all instructions in the operating panel have been carried out, you may continue by pressing the confi rmation key. The Help key is used to obtain additional information (help texts). The Back button is used to return to the previous screen. 20 / d GB/

21 3.2 Signals on the ultrasonic bath Symbols In some screens, symbols are used to underscore the information: Symbol Explanation Positive, error-free result Negative result Error message Key operation Correct key operation is visually identified by a reversing of the button colours, and it is acoustically identified by a signal tone (beeping). Caution! The operating panel should not be pressed too forcefully. Do not use your thumbs to press the buttons. 3.3 Connection and removal of the instruments Mounting of an adapter: Inspection glass Markings Clamp washer Sleeves for hose connection Adapter seal Fastening ring Rotating ring Adapter settings: open half-open closed 6376d GB/ / 62

22 Connecting the instrument: First connect the lower adapters, this will facilitate the operation. Check whether the adapter is fully opened. Slide the closed instrument all the way into the adapter, in the direction of the arrow, until the movable part on the tip of the instrument is fully visible in the inspection glass. Do not damage the adapter seal, e.g. by inserting the instrument out of perpendicular. Close the adapter. To do so, turn the rotation ring in a clockwise direction until it clicks (tensioning of the adapter seal). Clicking the ring three times ensures that the adapter seal is correctly sealed. 3 Important! Click a maximum of four times (the markings will then align once again), any additional clicking could cause damage to the adapter seal. Next, open the movable parts on the tip of the instrument to also guarantee disinfection and cleaning in that area. Check for correct positioning of the adapter in the comb bar; if needed, affi x new sleeves in the comb bar. The hose connection must be on top. 22 / d GB/

23 Removal of the instrument: First, close the movable parts on the tip of the instrument. Open the adapter. To do so, pull out the rotating ring somewhat and allow to snap back (if needed, turn carefully in a counterclockwise direction). Repeat this process several times until the marking on the fastening ring aligns with the short marking on the rotation ring. The instrument can now be carefully pulled out of the adapter. Do not damage the adapter seal. 6376d GB/ / 62

24 3.4 Connecting / removing the adapter testing stripes Connecting the testing stripes: Check whether all adapters are fully opened. Push the test plugs all the way to the stop ring in the adapters. Otherwise, it is not possible to conduct a correct adapter check. open Do not leave any adapter apertures open, since the ultrasonic bath will otherwise prompt for a replacement of adapter seals. Do not additionally close/twist (click in place). Test plug with stop ring ( Check for correct positioning of the adapter in the comb bar; if needed, affi x new sleeves in the comb bar.) Removing the testing stripes: Pull the test plugs from the adapters. 3.5 Opening and closing the outlet The oscillating tank's outlet is operated using an integrated ball valve (on ultrasonic bath MC 1001), or a turning knob on the drain set (on built-in ultrasonic bath MC 1001 E). Ultrasonic bath MC 1001 and Built-in ultrasonic bath MC 1001 E closed open open closed Ball valve to open or close the outlet. Turning knob to open or close the outlet. Depending on design, at the front or on top of the work plate 24 / d GB/

25 4 Use The SONOMIC ultrasonic bath is designed for multi-shift operation in a medical establishment. As many treatments as desired can be conducted within a single shift: A shift generally consists of 8 hours and includes preparation, 1 to 10 treatments, and post-processing. Preparation Once at the start of the shift - turn on - fi ll water, dose disinfection and cleaning agent - degassing (without user intervention) 15 min one shift (e.g. one working day) e.g. 10 treatments per shift First treatment Further treatments After treatment - adapter test (optional) - accommodate instruments - automatic treatment - remove instruments - adapter test (optional) - lay down instruments - automatic treatment - remove instruments min min Post-processing Once at the end of the shift - empty and rinse ultrasonic bath - replace fi lter - turn off 15 min The coloured work steps are explained next. 6376d GB/ / 62

26 4.1 Preparation of the ultrasonic bath Preparation of the ultrasonic bath is to be conducted once at the start of a shift, and after every change of bath fl uid. Start - After turning on, the welcome screen appears for approx. 5 seconds - language selection possible. Language selection Preparation Filling - Fill oscillating tank with water and suitable preparation. Self-test - A self-test checks all components. 1 min Degassing - Degassing of the bath fl uid is conducted. 10 min Start / Language choice Turn on the SONOMIC's mains switch. The welcome screen will appear for approx. 5 s. Within this time, the language can be selected if necessary by pressing the appropriate key. If no key is pressed, the ultrasonic bath will start using the last setting. In the next selection menu, press the "Start" key and follow the instructions on the operating panel. Filling To prepare the ready-for-use solution, you may only use water that is microbiologically at least of drinking quality, pursuant to KRINKO recommendations. For an optimal ultrasound effect, the fi lling temperature of the water should lie between 18 and 25 C. In addition, a suitable disinfection and cleaning agent should be added to the water in the oscillating tank, see chapter 7.3. Important! Verify that the outlet is closed. Distilled or deionised water without additives is unsuitable for treatment in the oscillating tank. Do not use any combustible fl uids (e.g. benzine, solvents) or chemicals that contain or separate out chloride ions (some disinfectants, household cleaners, and dishwashing detergents) for sonication in the stainless steel tank. The compatibility between the instrument and the preparation is to be verifi ed on the basis of the respective manufacturer's specifi cations. Working with aggressive preparations is strictly prohibited! 26 / d GB/

27 Self-test The ultrasonic bath activates all components successively and verifies the data communication. Any errors are displayed on the operating panel in the form of error codes. Additional information can be found in the appendix. Degassing Degassing the bath fl uid increases the ultrasound effect. Freshly-filled 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 fall 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. It rather means the end of the degassing process and an improvement in the ultrasound effect. Note Bath fl uid with an excessively low fi lling temperature (< 20 C) will be heated after degassing. 6376d GB/ / 62

28 4.2 Treatment of instruments In order to treat the instruments, there are 3 different programs (modes) to choose from: Mode 1: Disinfection and cleaning of rinsable MIS instruments 15-minute rinsing program with sonication, especially for combined disinfection and cleaning solutions, used, for example, with STAMMOPUR DR 8. Mode 2: Cleaning of rinsable MIS instruments 10-minute rinsing program with sonication especially for cleaning solutions without disinfecting effect, used, for example, with STAMMOPUR R. Mode 3: Disinfection and cleaning of simple (non-rinsable) instruments 5-minute sonication without rinsing function, especially for a combined disinfection and cleaning solution. The instruments are connected to the adapters for treatment modes 1 and 2. The included seals guarantee a secure, complete seal on the outer sheath of the instruments, which is indispensable for subsequent rinsing. In order to exclude defective seals, modes 1 and 2 will be invoked for an adapter check before every treatment, since the adapter seal is subject to process-related wear (ultrasound, opening, closing). Defective or leaking adapters are identifi ed once the test is completed. The adapter check is not required in mode 3 as the adapters remain open throughout the sonication. Note on temperature and fill level monitoring The SONOMIC controls the temperature and fi ll level of the liquid in the bath prior to every treatment. If the temperature is outside the permissible range of 20 to 40 C, or if the fi ll level falls below the sensor's permissible range, this is shown through respective warning messages on the operating panel. Further information is provided in the Appendix. 28 / d GB/

29 4.2.1 Mode 1 In mode 1, rinsable MIS instruments are treated according to the following procedure: Start - Select mode 1. - If needed, select an adapter test. Adapter check - Connect adapter testing stripes. - Test the adapters for tightness. 5 min a treatment Adapting of instruments - Connect instruments to the adapter. Treatment operation - The instruments will be rinsed thoroughly one after the other. Periodic ultrasound delivery. 15 min End - Remove instruments. Start After preparation, select mode 1 for the "Choose treatment mode" prompt on the screen. Next, follow the instructions on the operating panel. Adapter check Upon request, insert the adapter testing stripes included with delivery into the adapters, see chapter 3.4. Continue to follow the instructions on the operating panel. If identifi ed, replace the defective adapter seal(s), see chapter Adapting of instruments Properly prepare the instruments before treatment in the SONOMIC and rinse on the inside and outside with cold water (of at least drinking quality). Connect the instruments to the adapters (see chapter 3.3). Unused adapters should be left open. When laying in the instruments, please note: Only treat instruments that have been approved by their manufacturer for ultrasonic cleaning. Do not treat any damaged instruments. Disassemble take-apart instruments to the extent possible. When doing so, heed the manufacturer's instructions. Remove sealing caps / seals and place them loosely in the basket, open up valves, remove the Luer cap from instruments with a lateral rinsing connection. 6376d GB/ / 62

30 Do not place instruments directly on the tank bottom. The basket prevents damage to the instruments and tank bottom. Space instruments evenly apart, do not stack them. An overloading of the basket will reduce the ultrasound effect (the ultrasound is absorbed). Fragile parts must not touch each other. If needed, use special placement accessories such as silicone knob mats, see chapter 7. The instruments must be fully covered with fl uid. Treatment operation The treatment operation is conducted automatically. At the end, instruments that could not be rinsed through are individually displayed on the operating panel as "non-patent". Caution! "Non-patent instruments" have not been treated! They are to be individually removed according to the indication on the operating panel, and stored separately. Non-patent instruments must undergo another treatment, or they must be separately treated. End After removal of the instruments, these are to be intensively rinsed using water of at least drinking quality. Demineralised water should be used for the fi nal rinsing. Continue to handle instruments in accordance with the hygiene plan or KRINKO recommendations (e.g. drying, function control, sterilisation). After completion of treatment, a protocol will be issued by the interfaces if a receipt printer or PC is connected (chapter 1.5). Before every subsequent treatment, it is necessary to check whether the bath fl uid needs to be cleaned or replaced. 30 / d GB/

31 4.2.2 Mode 2 In mode 2, rinsable MIS instruments are treated according to the following procedure: Start - Select mode 2. - If needed, select an adapter test. Adapter check - Connect adapter testing stripes. - Test the adapters for tightness. 5 min a treatment Adapting of instruments - Connect instruments to the adapter. Cleaning operation - The instruments will be rinsed thoroughly one after the other. Periodic ultrasound delivery. 10 min End - Remove instruments. Start After preparation, select mode 2 for the "Choose treatment mode" prompt on the screen. Next, follow the instructions on the operating panel. Adapter check When prompted, insert the adapter testing stripes included with delivery into the adapters, see chapter 3.4. Continue to follow the instructions on the operating panel. If identifi ed, replace the defective adapter seal(s), see chapter Adapting of instruments Properly prepare the instruments before cleaning in the SONOMIC and rinse on the inside and outside with cold water (of at least drinking quality). Connect the instruments to the adapters (see chapter 3.3). Unused adapters should be left open. When laying down the instruments, please note: Only clean instruments that have been approved by their manufacturer for ultrasonic cleaning. Do not clean any damaged instruments. Disassemble take-apart instruments to the extent possible. When doing so, heed the manufacturer's instructions. Remove sealing caps / seals and place them loosely in the basket, open up valves, remove the Luer cap from instruments with a lateral rinsing connection. 6376d GB/ / 62

32 Do not place instruments directly on the tank bottom. The basket prevents damage to the instruments and tank bottom. Space instruments evenly apart, do not stack them. An overloading of the basket will reduce the ultrasound effect (the ultrasound is absorbed). Fragile parts must not touch each other. If needed, use special placement accessories such as silicone knob mats, see chapter 7. The instruments must be fully covered with fl uid. Cleaning operation The cleaning operation is conducted automatically. At the end, instruments that could not be rinsed through are individually displayed on the operating panel as "non-patent". Caution! "Non-patent instruments" have not been cleaned! They are to be individually removed according to the indication on the operating panel, and stored separately. Non-patent instruments must undergo another cleaning, or they must be separately cleaned. End After removal of the instruments, these are to be intensively rinsed using water of at least drinking quality. Demineralised water should be used for the fi nal rinsing. Continue to handle instruments in accordance with the hygiene plan or RKI recommendations (e.g. drying, function control, sterilisation). After completion of cleaning, a protocol will be issued by the interfaces if a receipt printer or PC is connected (chapter 1.5). Before every subsequent treatment, it is necessary to check whether the bath fl uid needs to be cleaned or replaced. 32 / d GB/

33 4.2.3 Mode 3 In mode 3, simple (non-rinsable) instruments such as scissors and forceps are treated according to the following procedure: Start - Select mode 3. - Place instruments in the basket. a treatment Treatment operation - Continuous ultrasound delivery. 5 min End - Remove treated instruments. Start After preparation, select mode 3 for the "Choose treatment mode" prompt on the screen. Next, follow the instructions on the operating panel. The instruments are loosely placed in the basket and not connected to the adapters the adapters remain open. An adapter check is not conducted in this treatment mode. When laying down the instruments, please note: Only treat instruments that have been approved by their manufacturer for ultrasonic cleaning. Do not treat any damaged instruments. Do not place instruments directly on the tank bottom. The basket prevents damage to the instruments and tank bottom. Fully open or disassemble forceps or scissors. Place the more heavily soiled side facing downward. In the case of hollow areas, ensure that the air can escape. Space instruments evenly apart, do not stack them. An overloading of the basket will reduce the ultrasound effect (the ultrasound is absorbed). Fragile parts must not touch each other. If needed, use special placement accessories such as silicone knob mats, see chapter 7. The instruments must be fully covered with fl uid. The treatment operation takes place automatically. 6376d GB/ / 62

34 End After removal of the instruments, these are to be intensively rinsed using water of at least drinking quality. Demineralised water should be used for the fi nal rinsing. Continue to handle instruments in accordance with the hygiene plan or KRINKO recommendations (e.g. drying, function control, sterilisation). After completion of treatment, a protocol will be issued by the interfaces if a receipt printer or PC is connected (chapter 1.5). Before every subsequent treatment, it is necessary to check whether the bath fl uid needs to be cleaned or replaced. 34 / d GB/

35 4.3 Post-processing of the ultrasonic bath Post-processing of the ultrasonic bath is to be conducted for reasons of hygiene prior to turning off the ultrasonic bath each time, and in the case of used bath fl uid. This guarantees an effective disinfection and cleaning action, and the ultrasonic bath is handed over to the next shift in clean, hygienic condition. Cleaning solutions must be replaced immediately in cases of visible contamination, but at least once every working day. In the case of working solutions of the disinfecting preparation, longer resting times are permissible if the manufacturer can verify, through expert reports, that the effectiveness of e.g. STAMMOPUR DR 8, remains present over a longer time period, even in the case of visible blood contamination, see chapter The manufacturer specifi cations regarding the service life must be observed. Furthermore, the oscillating tank must be mechanically cleaned and, if applicable, disinfected, every working day to prevent biofilms, according to KRINKO recommendations. Start - Start post-processing. Emptying / Cleaning - Open the outlet, dispose of used bath liquid. Rinse the inner walls using a hand spray. 5 min Post-processing Rinsing / Disinfection Emptying - Close the outlet and fi ll the tank with water without any additives. - Rinsing process is initiated. - A disinfection of the ultrasonic bath will be necessary if working with a bath fl uid that does not contain any disinfecting properties. (The duration will depend on the preparation used.) - Open the outlet and rinse the tank's inner walls using a hand spray; wipe dry. - Empty out the adapters and re-affi x in the comb bar. max. 60 min Filter change - Replace fi lter; if needed, back-wash the fi lter. End Start To start the post-processing, respond to the "Start additional treatment?" prompt by pressing "No". Follow the instructions on the operating panel (see appendix for additional information). Emptying The working solution should be disposed of pursuant to the specifications of the product leafl et and the label. 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 working solutions. 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 relevant preparation should be observed. 6376d GB/ / 62

36 During cleaning, materials hazardous to water such as oils, heavy metal compounds, etc., may enter the working solution, depending on the type of contamination. If the limit values are exceeded, the working solution must be reconditioned (removal of contaminants) or be disposed of as toxic waste. 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. Rinsing / Disinfection Following treatment modes 1 and 3 (used bath fluid = disinfection solution): Here, all parts in the ultrasonic bath that came in contact with the disinfection and cleaning fl uid, and thus with the contamination, are thoroughly rinsed with water. Following treatment mode 2 (used bath fluid = cleaning solution): In addition to the rinsing, a disinfection is also invoked here. If prompted, a suitable disinfection preparation (dosed according to manufacturer specifi cations) should be added to the fi lled water. IMPORTANT! The compatibility of the preparation used here to any previous preparations or preparations to be used in the future, e.g. in the cleaning and disinfection device, must be carefully verifi ed! If necessary, consult with the manufacturer. For the duration of the disinfection, 3 minutes should be added to the treatment time of the disinfection preparation, to allow for the safe rinsing of all channels. Therefore: "Total duration, disinfection" in mins = treatment time of the preparation + 3 min After reaching the total duration, the disinfection will be individually ended by the operator, or automatically after 60 mins. At the end, rinse thoroughly with water of at least drinking quality. Filter change / End The fi lter cartridge must be exchanged, see chapter Switch off the ultrasonic bath. In case of an extended period of non-use of the ultrasonic bath, it is recommended for hygienic reasons that an additional "pump out" be run. To do so, turn on the ultrasonic bath, go to the main menu and select the "Shutdown" key. Ignore the prompt to fi ll the oscillating tank and press the "Start rinsing" key. Any residual water present will be pumped out. Next, wipe out / wipe down the oscillating tank with a soft cloth. At the end, put on the lid to protect the tank interior from being contaminated from outside. 36 / d GB/

37 5 Cleaning and maintenance of the ultrasonic bath To achieve an optimum lifespan for the ultrasonic bath, cleaning and maintenance should be conducted regularly. An automatic cleaning process is thus conducted 1 x daily as part of post-processing, see chapter 4.3. Following are instructions for manual cleaning and care. CAUTION! Disconnect the ultrasonic bath from the mains before cleaning / maintenance. Do not rinse or immerse the ultrasonic bath in water and do not expose it 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 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 Thoroughly and frequently rinse the oscillating tank with water and wipe 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 protection layer of the stainless steel. The stainless steel is thereby "activated" and 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. Housing (MC 1001 or components of MC 1001 E) Wipe down only the exterior of the housing with a damp cloth and leave to dry or wipe dry. Do not use any abrasive cleaners, only commercial care products without abrasive additives. 6376d GB/ / 62

38 Functional cabinet Wipe down the housing inside and out with a moist cloth, then allow to dry or wipe dry. Do not use any abrasive cleaners, only commercial care products without abrasive additives. 5.2 Disinfection If contaminated medical instruments are treated in the ultrasonic bath, hygienic safety after application is important. An automated process for chemical disinfection of the ultrasonic bath and accessories is thus conducted 1 x daily as part of postprocessing in accordance with treatment mode 2, see also chapter 4.3. Thermal disinfection or sterilisation of the device components is not allowed. 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 should be regularly cleaned and disinfected pursuant to the hygiene plan using a VAH-certifi ed or effective surface disinfectant. 5.3 Warehousing / storage During longer terms of non-use, the ultrasonic bath should be disconnected from the mains (pull the mains plug from the power outlet). The lid should be put on in order to protect the ultrasonic oscillating tank from outside contamination. 38 / d GB/

39 6 Maintenance and repair 6.1 Maintenance The maintenance intervals provided assume daily use of the ultrasonic bath. daily monthly after approx. 1,000 operating hours All 2 years Part / object / remark X Post-processing, including replacement of the fl uid and the fi lter unit (see chapter 4.3 or 6.1.1) X Replace adapter seals (see chapter 6.1.2) X X Replace pump hose by authorised skilled personnel or by manufacturer Maintenance by authorised skilled personnel or by manufacturer The operator is responsible for planning and documenting maintenance. Appropriate maintenance lists (sample copies) are found at the end of these instructions for use. The preservation heating does not require servicing. 6376d GB/ / 62

40 6.1.1 Changing the filter During post-processing and in the event of a prematurely obstructed fi lter, a prompt for a fi lter exchange will appear on the operating panel. The fi lter can be replaced if the oscillating tank is full. To do so, the fi lter housing should always be fully removed from the tank so that the fi ltered-out contamination does not re-contaminate the tank bath during the exchange of fi lter cartridge. The entire fi lter housing is fi xed by a spring to the support, and can be removed by compressing the spring. Here, please ensure that the sealing rings on the connections do not get lost. The fi lter cartridges are suitable for backwashing. The fi lter cartridges can be used multiple times with appropriate, thorough backwashing. Removing the filter cartridge: Unscrew the lower fi lter housing (transparent). Pull out the fi lter unit from the head piece. Thoroughly rinse all housing parts with water. Sealing rings Inserting a new filter cartridge: Insert open side (straight) of the new fi lter cartridge into the head piece. Verify that all sealing rings are present. Re-screw the lower fi lter housing. Head piece Filter cartridge Sealing ring Lower fi lter housing 40 / d GB/

41 6.1.2 Replacing the adapter seal The adapter seals must be replaced every 4 weeks (approx. 500 treatment cycles). If the equipment does not pass the adapter check, all identifi ed adapter seals must also be replaced and the 4-week service life restarted. In order to replace the adapter seal, the adapter must be dismantled and reassembled. To do so, an assembly chip is required as a tool. Sleeves for hose connection Inspection glass Punched disc Adapter seal Marking Markings:»HK«and»L«Fastening ring Rotating ring Pressure disc Clamp washer Disassembling the adapter seal: Take the adapter out of the comb bar and pull off the hose. Unscrew the clamp washer using the assembly chip. Remove the pressure washer. Then, unscrew the conjoined rotating and fastening rings from the inspection glass. Pull out the defective/used adapter seal. Separate the rotating and fastening rings. To do so, align the»h«marking on the fastening ring and the»l«marking on the rotating ring, and pull both rings apart. Remove the punched disc from the inspection glass (click). Thoroughly rinse all detached adapter parts with water. Fitting the new adapter seal: Press the punched disc into the inspection glass (snap-in). Interlock the fastening and rotating rings. To do this, the»h«marking on the fastening ring and the»l«marking on the rotating ring must be aligned. Insert one half of the adapter seal through the hole of both rings. In this position, the adapter seal should be loose and not tilted. Firmly screw both rings together with the seal onto the inspection glass. Turn the rotating ring somewhat, so that the»h«marking on the fastening ring and the»k«marking on the rotating ring face each other. Insert the pressure washer nose fi rst (smooth side facing outwards) and hand tighten the clamp washer using the assembly chip. In the process, fi rmly hold the rotating and fastening rings in place the markings must not fall out of alignment! Insert the hose in the sleeves for the hose connection, and reaffi x the adapter in the comb bar. 6376d GB/ / 62

42 6.2 Functional check Checking the touchscreen Switch on the ultrasonic bath - the touchscreen must light up. The touchscreen should respond to the pushing of buttons and the relevant screens must appear. The press of a key is confi rmed through a change in key colour and a beep. Testing the device function After being switched on, the SONOMIC ultrasonic bath conducts a self-test with a corresponding fault analysis as part of preparation, see chapter 4.1 and/or the appendix. Further functional checks are only possible as part of servicing by authorised skilled personnel or by the manufacturer. Testing the ultrasound The function can be tested using a standard wattmeter. This is to be inserted between the ultrasonic bath's power plug and the power outlet. Turn on the ultrasonic bath. Fill the ultrasonic oscillating tank with liquid. Start treatment mode 3 for a check. Compare the value displayed with the corresponding value in the technical data (chapter 1.5) (tolerances ± 20 %). Checking the ultrasound effect For this check, it is recommended that a foil test be conducted. A suitable frame for a foil test can be requested from the manufacturer. Ordinary aluminium foil is used to conduct the test. Next, a comparison is made with previouslygenerated foils. As a departure from the detailed information in the appendix (which is intended for simple standard ultrasonic baths), please note the following special instructions for the SONOMIC: Turn on the ultrasonic bath. Fill the ultrasonic oscillating tank with liquid. Conduct degassing (10 min). Start treatment mode 3 (5 min) for a check. Important: After the foil test, the ultrasonic oscillating tank must be thoroughly rinsed so that no aluminium residue remains on the inside. Note: A measurement procedure is described in DIN SPEC 40170: (measurement and evaluation of the cavitation noise). 42 / d GB/

43 6.3 Malfunction / Fault analysis SONOMIC ultrasonic baths are designed for high reliability. A possible malfunction due to a defective component cannot be fully ruled out, however. Mechanical defects, e.g. on the adapters, hoses, etc. are also possible due to wear or improper use. The following overview of possible sources of error should serve as an aid for error detection and elimination. Error Possible cause(s) Measure Ultrasonic bath cannot be switched on (display remains dark) Is ultrasonic bath plugged in to power supply? Power switch correctly activated? Defective mains fuses? If needed, connect the ultrasonic bath to the power supply. Check that the mains switch is in position "I". If needed, replace fuse. No displays or incomprehensible displays Operating panel does not react to button pressing Message "Filter obstructed" reappears even when a new fi lter unit has been installed Message "Instrument in channel... nonpatent" reappears for the same channel, with no identifiable plausible cause. Message "Instrument in channel... nonpatent" reappears for all channels, with no identifi able plausible cause. Blinking progress bars? Operating panel defective? Key not pressed correctly? Button activated correctly but the ultrasonic bath does not react? The ultrasonic bath only reacts to the "Help" button? Operating panel defective? Filter installed incorrectly? Flow sensor defective? Are instruments in this channel not covered with fluid? Adapter incorrectly connected / mounted? Obstruction in the ultrasonic bath's hose system? Are instruments not covered with fl uid? Adapter incorrectly connected / mounted? Obstruction in the ultrasonic bath's hose system? Flow sensor defective? No error, the ultrasonic bath is preparing itself for operation. This can last up to 1 minute. This can only be rectifi ed by a service technician or the manufacturer. Control option: When activated, the buttons change colour (dark = button activated). An acoustic signal is emitted. Wait approximately 10 s, some functions require some time. If the ultrasonic bath does not react after 10 s, turn it off and switch it on again after another 10 s. Turn off the ultrasonic bath and turn it back on after 10 s. This can only be rectifi ed by a service technician or the manufacturer. Check fi lter housing and cartridge, see ch This can only be rectifi ed by a service technician or the manufacturer. If needed, fi ll with fl uid up to the fi lling level mark. Check adapters and adapter connections, see ch This can only be rectifi ed by a service technician or the manufacturer. If needed, fi ll with fl uid up to the fi lling level mark. Check adapters and adapter connections, see ch This can only be rectifi ed by a service technician or the manufacturer. This can only be rectifi ed by a service technician or the manufacturer. 6376d GB/ / 62

44 Error Possible cause(s) Measure Message "Insuffi cient fl uid..." reappears Unsatisfactory treatment results Ultrasonic bath oscillates weakly, unevenly or noise is too loud Does the ultrasonic bath crash on the welcome screen? Is fill level sensor soiled? Is fill level sensor defective? Correct dosing of the bath fluid? Degassing not conducted? Insuffi cient amount of cleaning and disinfection agent used? Instruments stored for too long in contaminated state? Overloaded with cleaning agents (instruments)? Irregular sounds? Defective oscillating system or HF generator defect? Has it been turned on and off too quickly? Clean the surface of the sensor in the oscillating tank. This can only be rectifi ed by a service technician or the manufacturer. Fill level sensor measures the guiding value. If required, increase the concentration or use tap water to prepare the bath fl uid, see ch Always conduct degassing during the treatment. Repeat treatment with a well-tested disinfection and cleaning agent such as STAMMOPUR DR 8. Repeat treatment or store instruments separately and treat manually. Remove a few parts. No error. Conduct a foil test and compare it to the fi rst test (conducted during commissioning). Request a test sheet and allow authorised, skilled personnel to conduct test. If an error is detected, the ultrasonic oscillating tank should be returned to the manufacturer for repair. No error. Turn off the ultrasonic bath and turn it back on after 10 s. Further error messages are displayed directly on the operating panel see appendix. 6.4 Repairs and service If errors or defects are ascertained as a result of the functional check, and if it is impossible to rectify such errors, the ultrasonic bath may no longer be used. In such a case, please contact the supplier or the manufacturer: BANDELIN electronic GmbH & Co. KG Heinrichstrasse Berlin Germany Repair service: Phone: +49-(0) info@bandelin.com Fax: +49-(0) In the case of returns, the general terms and conditions for delivery and payment of BANDELIN electronic GmbH & Co. KG shall apply. In addition, the ultrasonic bath must be cleaned and decontaminated (if necessary), see the following chapter. 44 / d GB/

45 6.4.1 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 the Internet as a PDF fi le: / Service / Download... A sample copy can be found in the appendix Replacing fuses Six fuses are built into the SONOMIC ultrasonic bath, which respond to defects or overload. If one fuse is blown, the ultrasonic bath will not function (the operating panel remains dark). In general, the ultrasonic bath is defective and must be sent to the manufacturer for repair. Caution! Only authorised skilled personnel may open the ultrasonic bath and replace the fuses, on the basis of the service instructions. 6376d GB/ / 62

46 6.4.3 Determining information on software version and report data In some cases it may be necessary to provide information regarding report data and the software version to authorised skilled personnel or to the manufacturer. Determining the software version: Turn on the ultrasonic bath. The welcome screen will appear for 5 s. Click on the Service/Care key on the main menu after the welcome screen. Then click the Operating data key. Take a photograph of the screen and send the photograph. Press the "<<" key twice and then the "Shutdown" key. Switch the ultrasonic bath off again. Software version of the controls Identifying report data: Turn on the ultrasonic bath. The welcome screen will appear for 5 s. Click on the Service/Care key on the main menu after the welcome screen (see above). Then, press the "Components" and "Operating times" keys. Take a photograph of the screen and send the photograph. Press the "<<" key three times and then the "Shutdown" key. Switch the ultrasonic bath off again. Software version of the operation Report data 46 / d GB/

47 7 Accessories The proper accessories facilitate use of the ultrasound and also protect the oscillating tank and instruments. BANDELIN offers a broad range of accessories. Additional information may be obtained from our supplier, our sales representative or from our website. No-obligation telephone consultation: Website: +49-(0) Required accessories See scope of delivery, chapter Optional accessories 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. Name D 1001 MC Lid Plastic (for both ultrasonic bath types) D 1001 G Hinged lid Stainless steel with gas spring (for ultrasonic bath MC 1001) D 1001 GE Hinged lid Stainless steel with gas spring (for built-in ultrasonic bath MC 1001 E) Order No Silicone knob mat For gentle and contact-free accommodation of fragile parts during treatment. Name Dimensions (L W) mm Order No. Sample arrangement: SM 1000 MC (2 ) 3313 SM 1000 MC 6376d GB/ / 62 Basket

48 7.3 Chemical agents Special cleaning and disinfecting preparations that are ultrasound-compliant, i.e. they are cavitation-conducive, biodegradable, easily disposable, gentle to the material and long-lasting, are required for use of the ultrasound. Water without any additives does not clean and/or disinfect. With SONOMIC, BANDELIN recommends the use of the STAMMOPUR concentrates STAMMOPUR DR 8 and STAMMOPUR R, by DR. H. Stamm GmbH, which have been especially developed for ultrasound use and which optimally utilise the ultrasound. IMPORTANT! The processing times for SONOMIC have been defi ned for a treatment time of 5 minutes with ultrasound use, in agreement with the recommended STAMMOPUR concentrates. If a different cleaning and disinfecting agent is used, it is important to ensure an equivalent treatment time! Furthermore, it is necessary to ensure that the agent used is free of aldehyde and does not feature any proteopectic properties. The use of powder-based disinfecting and cleaning agents is not recommended since they may cause severe damage to the ultrasonic bath's cable ducts and to instruments after a long treatment time when not fully dissolved, due to a concentration of active oxygen. When using powder-based agents, ensure that they have dissolved completely in the bath liquid! Notes: When using preparations, the safety instructions on the label and in the respective product leafl et must be strictly 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. We do not offer a guarantee for damage to the ultrasonic bath or or to the objects to be treated (instruments), arising from the use of inadequate disinfection agents or detergents. 48 / d GB/

49 7.3.1 STAMMOPUR DR 8 Disinfection and cleaning agent STAMMOPUR DR 8 has been especially developed for disinfection during simultaneous intensive cleaning in the ultrasonic bath. It enables very short ultrasonic treatment times and possesses a very high material compatibility. Highly-sensitive instruments are especially protected in this manner. Properties: - disinfects and cleans in one single step - cavitation-conducive optimum use of the ultrasound - biodegradable - Bactericidal, tuberculocidal, yeasticidal, virucidal against Vaccinia, BVDV, papovavirus, adenovirus, HBV, HCV, HIV, avian fl u - A-Virus H5N1 - aldehyde-, chlorine- and phenol-free concentrate, mildly alkaline, ph 9.4 (1 %) - odourless - extended service life of 3 days - VAH-certifi ed Use: 2% Ultrasonic bath MC 1001 Total fi lling volume 27 l (= 26.5 l water ml STAMMOPUR DR 8) Built-in ultrasonic bath MC 1001 E Total fi lling volume 27.5 l (= 27.0 l water ml STAMMOPUR DR 8) Order information: Packaging unit Order No. 2 l l l 936 Minimum order quantities: 6 2 litres, 2 5 litres or 1 25 litre Additional information regarding STAMMMOPUR DR 8 can be obtained from the Product Information and Safety Data Sheet, to be downloaded from d GB/ / 62

50 7.3.2 STAMMOPUR R Instrument cleaner STAMMOPUR R is a cleaning agent for thorough intensive cleaning of medical instruments and devices in an ultrasonic bath. It allows for short ultrasonic cleaning times, protecting especially sensitive instruments in the process. STAMMOPUR R is suitable for all materials used in Medicine. Properties: - very high cleaning effectiveness - cavitation-conducive optimum use of the ultrasound - biodegradable - high capability to remove blood; also removes stubborn, dried-in impurities - very high material compatibility - mildly alkaline, ph 9.6 (1 %), pleasant odour Use: 2% Ultrasonic bath MC 1001 Total fi lling volume 27 l (= 26.5 l water ml STAMMOPUR R) Built-in ultrasonic bath MC 1001 E Total fi lling volume 27.5 l (= 27.0 l water ml STAMMOPUR R) Order information: Packaging unit Order No. 2 l l l 976 Minimum order quantities: 6 2 litres, 2 5 litres or 1 25 litre Additional information regarding STAMMMOPUR R can be obtained from the Product Information and Safety Data Sheet, to be downloaded from 50 / d GB/

51 8 Consumable materials Name Pieces Order No. EF 1001 fi lter cartridges AD 1000 adapter seal ADS 1000 Adapter with seal APB 1000 Adapter testing stripes (consisting of 2 6 test plugs) Taking the unit out of service 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

52 A 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

53 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