User Manual. HD 450/HD 450 Injection. Cleaning and Disinfection Unit. HD 450/HD 450 Injection. Dear User

Transcription

1 HD 450/HD 450 Injection User Manual Cleaning and Disinfection Unit HD 450/HD 450 Injection Dear User We thank you for the trust you have placed in us in choosing to purchase this cleaning and disinfection unit. Like our other products, this cleaning and disinfection unit was manufactured and certified according to the strictest quality standards. However, please read this user manual thoroughly before operating this unit. Careful handling and care of the cleaning and disinfection unit helps increase its useful lifespan as well as preserve its value. IC Medical GmbH

2 To all doctors, doctor's assistants and service personnel Please read this user manual thoroughly before operating the HD 450/HD 450 Injection. Important: Follow all safety instructions in this user manual. Store this user manual safely in a location near the cleaning and disinfection unit. The user manual is to be regarded as part of the product. User Manual valid for HD 450/HD 450 Injection and HD 450 Modul IC Medical GmbH, Rudersberg-Steinenberg, Germany 4nd Edition April 2017 Responsible for the content are: IC Medical GmbH Schorndorfer Str Rudersberg-Steinenberg Germany info@icmedical.de IC Medical GmbH Subject to technical changes 0297

3 Unit name User manual Avoid danger Foreword Thank you for purchasing this cleaning and disinfection unit from IC Medical GmbH. In this manual, the cleaning and disinfection unit will be referred to as the HD 450/HD 450 Injection. The user manual contains important safety regulations and information that you will require to operate the HD 450/HD 450 Injection. Read the manual completely and thoroughly in the order presented. Read all safety regulations carefully before using the HD 450/HD 450 Injection. Please note the following Meaning Health risk Do not ignore Important information Explanation Indicates a dangerous situation. Should insufficient measures be taken to avoid such a situation, this may result in minor to life-threatening injuries. Indicates a dangerous situation. Should insufficient measures be taken to avoid such a situation, this may result in damage to the HD 450/HD 450 Injection or to the environment in which it is operated in. Points out important information.

4 Safety regulations Please observe the following safety regulations as well as the regulations in the individual chapters when operating the HD 450/HD 450 Injection. Suitability Use the HD 450/HD450 Injection only for the purpose indicated in the user manual. Power cord and power plug All legal regulations and connection conditions of the local electric supply company must be complied with in full. Do not modify or intentionally damage the power cord or the power plug. Do not operate the 450/HD 450 Injection when the power cord and/or the power plug are damaged. Do not pull on the power cord to unplug the power plug from the power socket. Always pull on the power plug to unplug the Setting up, installation, unit. When unpacking the unit, check it for any signs of operation damage that may have occurred in transport. Operate the 450/HD 450 Injection only in areas where there is no risk of explosions. The installation of the electric supply connections and the connections and waste water for water is to be supply done only by a trained technician. Daily use Use only instruments that have been approved by the manufacturer for automated decontamination in a cleaning and disinfection unit. Remember to observe the instrument manufacturer's instructions. It is especially important to follow the manufacturer's instructions when cleaning new equipment for the first time. When using additional accessories to hold instruments, in particular instruments with hollow spaces, the instructions provided in their user manuals by the manufacturer of the accessories are to be followed. When processing instruments, remember to observe the relevant regulations and guidelines, such as those from the RKI, BfArM, DGSV, etc., as DGKH well as the processing instructions of the instrument manufacturer the AKI. and All personnel responsible for the processing of instruments must be properly trained and possess the required knowledge. Operate the unit only with the base rack provided for this purpose. Processing media Be careful when using all types of processing media. The substances used for cleaning and neutralization and the rinsing agents components contain that are irritants or even corrosive agents. Use only processing media that have been approved for use in a cleaning and disinfection unit as well as specially approved for use in the HD 450/HD 450 Injection. Remember to follow all the manufacturer's instructions for use and safety regulations when using the processing media. Should the processing media cause any undesirable results with the manufacturer's the materials of instructions the instruments were and followed, the HD the 450/HD manufacturers 450 of processing are to be held medium responsible. However, should processing media be used that are not approved, IC Medical will not assume any

5 responsibility for damage to the unit or instruments. Should you have any questions concerning the compatibility of the process with the instruments, media please contact their manufacturer(s). IC Medical provides instructions on the use of processing media in the HD 450/HD 450 Injection, but assumes no responsibility for the effect they may have on the instruments. Any remaining fluid in the receptacle and the base pan below it may also contain processing media in case of damage. Always follow the safety regulations provided by the processing media manufacturer. Maintenance The maintenance of the unit is to be carried out only by authorized persons. Storage and transport Install and operate the unit in a frost-free environment. Store and transport the unit in a frost-free environment. Malfunctions Should you repeatedly receive error messages when operating the HD 450/HD 450 Injection, take the HD 450/HD 450 Injection out of operation and contact an authorized party. Only authorized persons are allowed to perform repairs on the cleaning unit.

6 TABLE OF CONTENTS Chapter 1 Specifications..7 Intended use and purpose Advantages for the user..7 Chapter 2 Description of unit.9 Package contents.9 Status bar on display...9 Views of unit 10 Accessories for loading the unit...11 Insertable frames and instrument baskets. 12 Acoustic signals.. 13 Automatic door locking mechanism...14 Emergency release...14 Water softening system.15 Chapter 3 Initial operation..16 Requirements for setting up, installing and operating the unit...16 Requirements for the location of the unit...16 Connections.16 Different ways of setting up...17 Space requirements 17 Topping up regenerative salt.18 Processing media...19 Filling rinsing agent.20 Dosage..21 Turning the HD 450/HD 450 Injection on/off...21 Requirements for initial operation..21 Chapter 4 Cleaning and disinfecting 22 Types of loads..22 Dental transfer instruments 22 Loading washware..23 Before the start of each program, take note of the following 24 Closing the door..24 Starting a program..25 Start time preselection...26 When the program is running...27 End of program 28 Manual program cancellation. 29 Removing washware..30 Chapter 6 Logs...38 Batch protocol. 38 Using a USB stick as output medium. 39 Computers as output media. 40 HD450-Printer Example of a log record Chapter 7 Maintenance 43 Cleaning...43 Cleaning the injection filter 46 Avoiding stains Maintenance (Process) Validation...50 Chapter 8 Operational breaks 51 Breaks...51 Taking the unit out of operation Transportation..52 Putting the unit back into operation after a move...52 Chapter 9 Function test...53 Automatic function test..53 Manual function test...53 Tests in daily use...53 Chapter 10 Malfunctions.54 Warnings..54 Malfunction messages 54 Before calling us..55 Malfunction messages 57 Technical data 59 Operational data 60 Appendix A Symbols on the unit..61 Chapter 5 SETUP-MENU...30 User menu Admin menu

7 Chapter 1 Specifications Chapter 1 Specifications Information contained in this chapter: Intended purpose of the HD 450/HD 450 Injection. The advantages of using the HD 450/HD 450 Injection. Range of application Cleaning and disinfection Intended use and purpose The HD 450/HD 450 Injection is intended for use in medical applications, e.g. in clinics, medical and dental practices. According to DIN EN ISO and -2, the HD 450/HD 450 Injection is regarded as a cleaning and disinfection unit. With this unit, thermoresistant medical instruments (instruments that are heat-resistant up to a temperature of 95 C) can be maintained automatically, provided that they are suitable for this purpose. The cleaning is carried out with water together with a chemical cleaning agent. Following which, a disinfection process utilizing heat takes place. When using the HD 450/HD 450 Injection, please observe the following. Note: The HD 450/HD 450 Injection is not suitable for the maintenance of thermolabile Instruments (e.g. flexible endoscopes). The HD 450/HD 450 Injection is not suitable for the processing of waste for disposal and in the laboratory environment! Universal application Drying Advantages for the user The HD 450/HD 450 Injection cleans and disinfects. The disinfection phase is conceived such that a minimum A0 value of 3000 is achieved. This means that vegetative bacteria and fungi and/or fungal spores are destroyed, and viruses (incl. HBV) are deactivated; i.e. the effective range AB according to the RKI directive is fulfilled. The HD 450/HD 450 Injection possesses a drying unit. However, certain instruments with empty cavities, e.g. turbines, must be dried separately due to their geometry. 7

8 Chapter 1 Specifications Automatic filter monitoring The HD450 Injection automatically detects situations where insufficient water is passing through the injection filter. Built-in water softening The HD 450/HD 450 Injection has a built-in water softening s y s t e m. The water hardness of the local drinking water supply can be entered into the HD 450/HD 450 Injection, allowing for the optimal operation of the water softening system. This also guarantees the optimal flushing out of chlorides. Rotation speed monitoring of the washing arm Monitoring of the cleaning process When a program is running, the rotation speed of the washing arm is monitored constantly. This ensures that the cleaning process completes without a hitch and that the washing arm is not blocked, e.g. by instruments underneath it in the washing chamber. When a program is running, the water in circulation is monitored via a sensor. At the same time, the washing arm and chemicals involved in the process are analyzed. Automatic conductivity measurements USB, Ethernet Display The HD 450/HD 450 Injection constantly monitors the conductivity of the rinse. If the conductivity was too high in the last final rinse, a warning message is displayed and the cleaning and disinfection process is marked as being incomplete. For a reliable and convenient documentation of the cleaning and disinfection process and as an important requirement for the data transfer process, USB and an ethernet ports are integrated. This allows the data to be transferred easily from the HD 450/HD 450 Injection onto the computers of the practice. Via the display, you will be able to start the program and set all relevant parameters. Door locking mechanism The HD 450/HD 450 Injection has an automatic door locking mechanism with a servo motor lock. Emergency release The emergency release allows the door to be opened in case of a power failure or in case of a malfunction. 8

9 Chapter 1 Description of unit Chapter 2 Description of unit Information contained in this chapter: Standard components included as part of the package Symbols on the display screen The components of the HD 450/HD 450 Injection Security features of the HD 450/HD 450 Injection Standard package contents Package contents HD 450/HD 450 Injection User manual Installation logs Declaration of conformity USB stick with recording program Accessories As ordered This cleaning and disinfection unit was extensively tested at the factory and found to be in perfect working condition. However, it is possible that small water spots remain. These will disappear in the first wash cycle. Status bar on display Cleaning cycle (batch) No. of cycles to date Network Unit is connected to practice network USB stick USB stick inserted Door locked Door unlocked Rinsing agent Rinsing agent has been filled Water softening Water softening system active 9

10 Chapter 2 Description of unit Front view Views of unit Door handle Power switch Control and display panel USB port Back view Mains connecting lead External control panel (optional) Ethernet network connection (RJ45) Cold water connector (CW) Waste water connector Inside view Connecting port for injector ail (HD 450 Injection) Water supply port (CW) + FD water Receptacle for salt Washing arm Wide-mesh and fine-mesh screen Cleaning chamber for processing media Neutralization chamber 10

11 Chapter 2 Description of unit Accessories for loading the unit The HD 450/HD 450 Injection must be equipped with a base rack for operation. Users may select between a base rack without an injector rail and a base rack with an injector rail for loading instruments with hollow cavities. You will find other accessories and information on their usage, such as insertable frames for washing trays or screening units, strainer baskets, instrument holders etc. in the enclosed accessory list. Racks and Instrument baskets Based on this pattern loading is to see how the test tube racks and the instrument basket are preferably to be arranged. The baskets must be along and rear hooked into the base rack. 1 x Flexio basic basket 1 1 x Flexio inlay basic bastek x Flexio- injection bar 8 adapter 1 x Flexio adapter for air scalers 1 x Flexio universal tuve adapter 4-6 mm 2 x Flexio basket open 2 x Flexi instrument holder 1 x Flexio sieve cage 10x10 1 x Flexio holder small part box MONO 1 x Flexio small part box fine-meshed 11

12 Chapter 2 Description of unit Components Components External operation panel - HD 450/HD 450 Injection Injection filter (content: 15 pieces) Flexio-basic basket 1 Flexio-basic basket 2 Flexio-Injection bar 8 adaptor Flexio-Injection bar 18 adaptor Flexio-Inlay basic basket 1 46x46 Flexio-Inlay basic basket 1 15x15 Flexio-Inlay basic basket 1 10x10 Flexio-Pin 1 (content: 5 pcs) Flexio-Pin 2 (content: 5 pcs) Flexio-Pin 3 (content: 5 pcs) Flexio-Pin 4 (content: 5 pcs) Flexio-Pin 5 (content: 5 pcs) Flexio Sieve cage 10x10 Flexio-basket open Flexio-deposit fine-sieve 2,5 x 2,5 Flexio instrument holder Flexio instrument holder ENT 144 Flexio tray holder 2 Flexio salver holder Flexio tray holder 7 Flexio universal holder for 4 specula or 11 forceps Flexio universal holder for 8 specula or 21 forceps Service-Kit for HD 450/HD 450 Injection Flexio instrument holder ENT 16 Flexio adapter for dental air scalers Flexio universal tube adapter 4-6 mm (content: 4 pieces) Flexio medicinal silicone hose 2 m System separator Aqua stop Flexio holder small part box DUO Flexio small part box fine-meshed Flexio small part box coarse-meshed Flexio holder small part box MONO Part number

13 Chapter 2 Description of unit Signal Keypress 3-level acoustic signals The HD 450/HD 450 Injection gives acoustic signals. These are meant to attract your attention and serve to provide you with information. In the administrator menu, you will be able to configure these signals to suit your needs. Meaning Confirms the correct pressing of a key 20 x 0.5 seconds Program concluded with success 10 x 5 seconds Malfunction (error) 13

14 Chapter 2 Description of unit Opening and closing the door Automatic door locking mechanism The automatic door locking mechanism ensures that the door is locked securely and tightly when a program is being run. The locking takes places via a servo motor lock. This means that the HD 450/HD 450 Injection m u s t b e connected to the power grid and turned on at the power switch in order to open and close the door. If the cleaning and disinfection program has been started, the door locks automatically after a personal code has been entered. The door remains locked during the process and cannot be opened. In order to open the door, enter your personal 3-digit code. Only then will the door be unlocked and can then be opened. To open, pull forwards on the door handle. WARNING! When the program is running, the door can only be opened if the program is canceled by the user. Never open the door forcefully! After the program has been interrupted or ended, the door can be opened with the 3-digit personal code. Emergency release In the event of a power failure, the door of the HD 450/HD 450 Injection cannot be opened to remove the instruments inside. In such a situation, the emergency release may be used. The emergency release is found on the right side of the bottom of the unit (see photo) Pull on the loop all the way. At the same time, pull on the door handle and open the door. Correct the malfunction. Never pull on the emergency release when a program is running! Hot steam may be emitted. The metal surfaces are extremely hot. Scalds and burns may result if these warnings are ignored. 14

15 Chapter 2 Description of unit Water softening system For the error-free operation of the unit, the HD 450/HD 450 Injection requires softened water. Tap water that exceeds a certain hardness level (21 dh) must be softened in order that no deposits gather on the instruments and the inside of the cleaning unit. This is why the unit has an in-built water softening system. The resulting water quality and performance is optimally configured for the HD 450/HD 450 Injection. For the regeneration of the water softening system, IRA salt (Art.No ) is to be used. WARNING! The in-built water softening system is optimized for a hardness level of dh. For levels higher than 40 dh, an external water softening system is required. If an external water softening system is used, it is sufficient to use the Thermo Tab (Art.No..: ) as the processing medium. Water hardness is always measured in dh. dh mmol/l f e dh mmol/l f e dh mmol/l f e Table 1: Conversion table for water hardness 15

16 Chapter 3 Initial operation Chapter 3 Initial operation Information contained in this chapter: Who is allowed to set up, install and operate the HD 450/HD 450 Injection Other requirements that must be fulfilled for the setting up and installation Different ways of setting up the unit How to top up regenerative salt Filling processing media Filling rinsing agent Turning the device on and off Requirements for setting up, installing and operating the unit The HD 450/HD 450 Injection is to be set up, installed and operated only by persons who have proof of their competency or are operators of a practice. Observe all instructions in this chapter when operating the unit for the first time. According to current VDE regulations, the HD 450/HD 450 Injection is not suitable for use in areas that have an explosion risk. The HD 450/HD 450 Injection is intended for use away from patient areas. The minimum distance from the treatment location must be at least 1.5 meters in radius. Should these instructions not be followed, damage to the HD 450/HD 450 Injection and/or injury may result. Requirements for the location of the unit Location The HD 450/HD 450 Injection is to be set up in a dry and dust-free location. The humidity at the unit's location is to be % and the ambient temperature C. Should this not be the case, this may cause malfunctions in the unit. Please ensure that the unit is on a level surface. However the unit is set up, there are to be no installations in the area near the rear panel. When setting up or installing the HD 450/HD 450 Injection, ensure that adjacent built-in cabinets or other pieces of furniture are resistant to condensed water. Should this not be the case, any water vapor and/or steam emitted may cause damage to surrounding installations. Connections The electrical connections and the connections for water supply and waste water are to be installed only by authorized personnel. Failing to do so may result in short circuits, fire, water damage and/or electrical shocks. Serious injury may result. 16

17 Chapter 3 Initial operation For the installation and the initial operation, the instructions in the technical handbook are to be observed. Different ways of setting up You may choose to set up the HD 450/HD 450 Injection in the following ways: As a built-in unit in a recess intended for this purpose and an already existing continuous work surface Freely positioned in a room on a work surface Built-in Space requirements The unit fits into a normal 60 cm recess next to built-in cabinets in your practice. HD450 HD450 Injection Width A 555 mm 555 mm Height B 450 mm 450 mm Depth C 505 mm 580 mm D 870 mm 940 mm E 30 mm 80 mm 17

18 Chapter 3 Initial operation Fill with regenerative salt if necessary! For a water hardness level of more than 21 dh, use only special IRA salt (Art.No.: ). Never fill cleaner or other types of processing media into the salt receptacle! This may cause the water softening system to malfunction. Topping up regenerative salt 1. Open the lid in the washing chamber. 2. Before the initial operation, fill in half a liter of water into the salt receptacle so that the salt dissolves. 3. Fill the storage receptacle completely. The storage receptacle holds approximately 1.0 kg of salt. 4. Ensure that the opening for filling salt is clean from any remaining salt as well as any overflowing brine, in order that the cap may be replaced tightly. 5. Screw the cap back on. WARNING! After the initial filling up of the salt receptacle, no additional water is required. You can top up the salt at any time. Rinse away any remaining salt in the washing chamber with tap water before the next operation of the unit! Water softening Salt supply full symbol is green Salt supply exhausted symbol is orange 18

19 Chapter 3 Initial operation Processing media Protect your eyes, hands, clothing and metal surfaces from coming into contact with the processing media. They contain components that are irritants or even corrosive agents. Any type of liquid remaining in the unit in case of a malfunction may also contain processing media. Should there be any contact with the processing media, be sure to follow the processing media manufacturer's instructions. Use only Thermo Tabs (Art.No ) und IRA salt (Art.No ). Damage to instruments and the washing chamber may result otherwise. Inserting processing medium Open cleaning chamber Insert cleaning tab into the dry cleaning chamber Close the cleaning chamber (shuts with a click) 19

20 Chapter 3 Initial operation Fill with rinsing agent if necessary! Check the suitability of instruments for use with rinsing agents. WARNING! If you notice visible streaks on the instruments, the cause could be an overdose of cleaning agent. If cleaning agent is missing or insufficient, the corresponding information will be displayed, and you will be prompted to add cleaning agent. 20

21 Chapter 3 Initial operation Dosage The tab enables an optimal and consistent dosage of the processing medium. Use only Oxides Thermo Tabs (Art.No ). as processing media. Turning the HD 450/HD 450 Injection on/off Please observe the following safety precautions when handling the power cord and power plug. Never splice or modify then power cord. The power cord has a maximum length of 2 m. Never pull on the power cord to unplug the power plug from the socket. Always pull on the power plug to unplug the unit. Do not place any heavy objects on the power cord. Never lay the power cord over areas where the cable may be pinched (e.g. caught in a door or window). Do not lay the power cord along a heat source. Do not use any nails, staples or similar objects to hold the cord in place. Should the power cord or the power plug be damaged, cease operation of the unit. The power cord and power cable may only be replaced by authorized persons. Failure to observe these instructions may result in damage to the cable or plug and/or cause a fire or electric shock. Serious injury may result. Turn on the HD 450/HD 450 Injection by pressing the power switch momentarily. Turn off the HD 450/HD 450 Injection by pressing on the power switch for 3 seconds. Requirements for initial operation If available, ensure that the water softening system is connected. Ensure that cold water supply is turned on. Ensure that power switch is turned on. Ensure that processing medium (Thermo Tab, Art.-No ) has been inserted. Ensure that the base rack has been inserted. Ensure that salt receptacle has been filled with enough salt (if necessary, see Chapter 2 water softening system). 21

22 Chapter 5 Cleaning and disinfecting Chapter 4 Cleaning and disinfecting Information contained in this chapter: What you should take note of when preparing washware How to load the cleaning and disinfection unit properly/arrange washware How to start a program The phases of a program How to cancel a program How to see if a program has been completed successfully What to take note of when removing washware Types of loads You may clean and disinfect the following types of washware in the HD 450/HD 450 Injection: Solid instruments up to a max. of 6 kg Glassware, e.g. beakers, test tubes etc. Bowls, dishes, and receptacles Hollow objects, e.g. suction cannulas, which are attached to hollow nozzles or transfer instruments, e.g. handpieces and elbow attachments using an adapter. Dental transfer instruments Use only turbines, handpieces and elbow attachments which manufacturers have approved for use with automatic processing in a cleaning and disinfection unit. Be sure to follow the instrument manufacturer's instructions. Should there be any undesirable results with the handpieces and elbow attachments even though the manufacturer's instructions were followed, the responsibility lies with the manufacturer. Suitable program Suitable processing media Take note of the following before using the unit to process instruments The outer surfaces of the handpieces and elbow attachments should be free from any remaining substances, e.g. dental cement. Air canals and spray canals must be free all the way through Wherever possible, do not allow any dirt or impurities to dry on and inside the handpieces and elbow attachments. A Thermo Tab must be used for cleaning. 22

23 Chapter 4 Cleaning and disinfecting Cleaning the adapter for transfer instruments The adapters for handpieces and elbow attachments should be checked regularly for any signs of dirt or stains. Silicone inserts can be rubbed clean with a moist, lint-free cloth. Changing the filter of the HD The white injection filter (Art. No ) in the adapters are 450 Injection to be changed after 20 cycles each, as they clog up slowly with dirt particles (Chapter 7). Note that cycles not involving handpieces and elbow attachments also count towards these 20. If the injection filter needs to be changed, this will be indicated on the display. Change the injection filter as indicated in chapter 7. After carrying out the filter change, a personal code has to enter to confirm the change. Each injection filter change will be recorded and saved in the system. Before inserting the filter cylinder into the adapter it should be rinsed quickly under running water. Care of instruments Leading manufacturers recommend that additional drying of the spray, air and water canals be done immediately after a cleaning and disinfection program with clean compressed air, after which they should be maintained with suitable care products/oils. Remember to observe your country's local regulations. Loading washware In order to load washware, you need to insert at least the base rack. This is available with an additional injector system for the dental sector. Other accessories, such as insertable frames, instrument baskets, washing trays, screening units and instruments are always placed into the base rack. When using the insertable rack for washing and screening units, it should be placed into the base rack such that the washing or screening units are tilted forward. If you are using a base rack with injector rail, ensure that the base rack is always pushed all the way to the back of the washing chamber, in order that the injector rail is connected securely to the connector nozzle in the inner wall of the washing chamber. Be careful when inserting sharp or pointed instruments and arrange them to minimize the risk of injury; we recommend loading the rack from back to front. It is also recommended that you wear appropriate protective gloves. Baskets and straining units with a wire mesh or other openings are not an adequate form of protection against pointed instruments, which may poke through. Failure to observe these instructions may result in injury. 23

24 Chapter 5 Cleaning and disinfecting Take note Empty all containers of any remaining liquid before placing them into the cleaning unit. Rinse away any hazardous liquids remaining in them, such as disinfectant. Individual instruments should be placed in baskets or trays never directly into the base rack. Instruments are not to extend out over the sides of the instrument baskets etc. Protruding instruments may otherwise damage the door seal or the side walls of the washing chamber. Instruments must not hang through the wire mesh of the baskets and protrude through the base of the rack. Otherwise, they may scratch the door surface, or parts of the instruments may break off. Hollow objects must be placed over or in the injector nozzles. Transfer instruments must be inserted over one of the 8 silicone adapters. The washing arm must be able to turn unobstructed and must not be blocked by any instruments protruding downwards. The results of a good cleaning are dependent on the correct placement of the instruments. Avoid arranging them such that certain areas do not get sprayed. Instruments are not to cover each other. All vessels such as glasses, dishes etc. are to be placed with the opening facing down. Objects with openings or recesses should be placed at a slant such that the water can run off. Use only undamaged instruments suitable for washing made of instrument steel to prevent corrosion. Use thermoresistant plastic components that are stable up to at least 95 C. Visual inspection before the start of each program Before the start of each program, take note of the following In order to ensure the cleaning performance before the start of each program, the following need to be fulfilled: Nozzles of the washing arm must be unobstructed and clean. The washware must be placed correctly. The washing arm must be able to turn freely; for safety reasons the rotational speed of the arm is monitored constantly when a program is running. If necessary, wash the wide-mesh and fine-mesh screens. The nozzles and/or the adaptor of the injector systems must be clean. Thermo Tab has been inserted. Closing the door Shut the door by pulling it upwards and press it closed tightly. Press start and enter your personal 3-digit code. 24

25 Chapter 4 Cleaning and disinfecting Starting a program on the HD 450/HD 450 Injection Use the power switch to turn the unit on. The display comes on. Wait until the HD450 HD 450 Injection is ready. Starting a program Never leave the unit unattended when it is running. The unattended operation of electrical devices, including that of the HD 450/HD 450 Injection, is at your own risk. The company will not be liable for any resulting damages arising from an unattended operation of the unit 25

26 Chapter 5 Cleaning and disinfecting Start time preselection The thermal disinfector HD450 and HD450 Injection has a freely programmable time delay. To optimize your processing time, you can select the free start time between 1 and 99 hours in the hour rhythm. The thermodesinfector then starts automatically at the desired time. For a delayed program start, select "Start time". Now you can select any start time. After selecting the start time, confirm the entry with "OK" and enter a 3-digit code. Once the start time has elapsed, the thermodisinfector starts automatically. 26

27 Chapter 4 Cleaning and disinfecting Sump rinse Pre-wash Cleaning Intermediate rinse Disinfection Drying Following the progress of the program on the display When the program is running After the start of the program, you can monitor its progress in the display. When the program is running, the different steps are shown on the display. Any remaining water is first rinsed out before a new cleaning cycle begins. A pre-wash takes place with water that does not contain any processing media and is temperature-controlled. This serves to mechanically remove any large organic particles adhering to the instruments. Any proteins remaining on the instruments must be removed entirely in order to prevent denaturation caused by water temperatures that are too high. This is where the actual cleaning cycle begins. The washing chamber is heated continually to a temperature specified by the program and the temperature maintained during the maintenance time. The processing medium is added automatically before the maintenance time begins. An intermediate rinse takes place as a preparatory step before disinfection, in order to reduce the concentration of any remaining processing media. A thermal disinfection with water takes place in this step. Finally, the instruments are dried on the inside and outside by opening the door. Narrow-necked instruments must be dried manually. You can monitor the current progress of the program currently running on the display and the current time remaining. HD450 / HD450 Injection - cleaning and disinfection program Pre-wash 1 Pre-wash 2 Main wash Intermediate rinse 1 Disinfection Drying 27

28 Chapter 5 Cleaning and disinfecting WARNING! Narrow-necked hollow instruments are to be dried manually by passing clean and oil-free air through them! Hollow instruments have not shifted and/or are still fixed in place Otherwise, they need to be processed again. The inside (lumen) of the hollow instruments are unobstructed and free. The injector system is still firmly attached to the connector nozzle of the washing chamber. The nozzles and connectors to the base rack are still securely attached. When all the points above are fulfilled and the program has completed without any interruptions or malfunctions, the washware has been successfully been cleaned and disinfected. End of program From the messages displayed and the beeps emitted you will be able to hear and see when and if a program was completed successfully. You then need to enter your personal code to unlock the door, which must then be opened immediately. This ensures optimal drying. Visual inspection at the end of every program. WARNING! Open the door immediately after the program ends in order to prevent the formation of condensed water. What to look for after a cleaning program has completed: The instruments must be completely clean and dry. 28

29 Chapter 4 Cleaning and disinfecting Manual program cancellation All running programs can be canceled at any step; however, if the program is canceled during the drying phase, the washware is not to be considered cleaned or disinfected. Where required, the program must then be run again. Therefore, the cancellation of a running program by the user should only occur in exceptional cases. WARNING! Depending on the point in time the program is canceled, the temperature of the washing chamber may be hot enough that it is not possible to open the door due to safety considerations. You will be able to open the door as soon as the temperature in the washing chamber has cooled down to < 75 C. Manual program cancellation before drying commences If a program is canceled before drying begins, the program is to be considered unsuccessful. When canceling a program and removing washware, please observe the following: There is a risk of contamination if the program is canceled before the disinfection has been completed successfully. Therefore, special caution is required when handling the instruments. Please note that instruments may still be extremely hot when the door is opened after a program cancellation. There is a risk of being scalded or burnt. Never interrupt a program by turning off the power switch. 29

30 Chapter 5 Cleaning and disinfecting Removing washware Please note the following during a program run and when removing washware at the end of a program: Never use force when opening the door. The HD 450/HD 450 Injection may be damaged in the process and/or hot steam may be emitted from the unit. If these instructions are not followed, scalds, burns or chemical burns may result. Especially large and solid instruments may still be extremely hot after the program has ended. Before removing the instruments, the instrument baskets and insertable frames, allow them to cool. If these instructions are not followed, scalds and burns may result. 30

31 Chapter 6 Logs Chapter 5 MENU / SETTINGS The HD450 / HD450 Injection offers 2 menu levels. - User menu: This is where users can set their personal preferences. - Administrator menu: This is where all the basic settings for the unit are set. Accessing the menu Start screen: press MENU Enter user code User: 3 digits; Administrator: 6 digits Depending on the code entered, the user or admin menu is then displayed. User menu User menu Export memory Select whether all or only new entries are to be exported. Confirmation of export 31

32 Chapter 6 Logs Setting time and date Using the arrows, set the current time and date. Press OK to confirm. Setting language Now the user can set his or her own language. Press OK to confirm. Confirmation message in the selected language Note that the language for each user can be set separately! 32

33 Chapter 6 Logs Administrator menu Administrator menu Add user Enter name and press OK to confirm are to be exported. Enter 3-digit code and confirm with OK entries 33

34 Chapter 6 Logs User added successfully Please note that each user has to have his or her own code. Up to 32 users may be added. Deleting a user Select desired user and select OK to confirm. Confirm delete Confirmation message Edit administrator Enter desired name. Press OK to confirm. A code must be provided here. 34

35 Chapter 6 Logs Export memory Select whether all or only new entries are to be exported. Confirmation of export Formatting memory IMPORTANT!!! Before the memory is erased, all records must be exported. If this is not done, it is possible that records are lost. Safety warning before format. Progress display Confirmation message Network settings Settings available for the network of your practice In the original factory state, DHCP is activated, and when the HD450 / HD450 Injection is connected to the network through the ethernet port, the unit will automatically be assigned an IP address from the server. The settings may also be entered manually. Please contact your administrator. 35

36 Chapter 6 Logs Setting time and date Using the arrows, set the current time and date. Press OK to confirm. Sounds & keypresses Select the desired options for your environment. Manual filter change Enter user code Confirmation message Records will be kept in memory of who changed the injection filter. Removing lime deposits Depending on the hardness of the water, you may turn on/off the water softening system here. For more information, refer to chapter 2 - Water softening system 36

37 Chapter 6 Logs Setting language This is where the local language of the unit can be selected. Confirmation message in the selected language. This setting applies for the entire unit and all users. Exporting transfer data Backup unit settings Confirmation screen No records are backed up with the transfer data. This backs up the basic settings, users and administrators. If the unit has to be reset to factory settings, the data can be re-imported in this manner. If possible, back up all data every time a new user is added. Importing transfer data Restore unit settings Confirmation screen 37

38 Chapter 6 Logs Update firmware Confirm with YES You will then be guided through the menu. 38

39 Chapter 6 Logs Chapter 6 Logs Information contained in this chapter: Why and how to document batches What output media you can use for batch documentation Program HD450 printer How to read the logs properly Batch protocol The batch documentation is vital for proof of a successfully completed cleaning and disinfection process, as well as crucial as a mandatory measure to ensure quality(mpbetriebv). Data such as program type, batch and process parameters of logged cleaning and disinfection cycles are stored in the internal log memory of the HD 450/HD 450 Injection. For batch documentation, the internal log memory can be exported and transferred to a variety of output media. This can take place immediately after each completed cleaning and disinfection process or at a later date, e.g. at the end of an office day in your practice or at a later date of your own choosing. You have the option of exporting the logs of the cleaning and disinfection cycles onto the following output media and to archive them accordingly: Output media USB stick Computers in the network of your practice Output media may be combined as desired This makes it possible to save logs on e.g. a USB stick and to print it out at a PCE. Capacity of the internal log memory The capacity of the internal log memory is sufficient for approx. 2,400 cleaning and disinfection cycles. If the internal memory is full, the warning message "Internal program log memory full" appears. When this warning message appears, you must export the internal logs onto a USB stick or via a computer. The internal memory must then be formatted (see administrator menu). Only then will the cleaning and disinfection unit be ready for use again. 39

40 Chapter 6 Logs Using a USB stick as output medium Please note the following when using a USB stick: Never use force to insert the USB stick into the USB port. Never pull the USB stick out of the port when read/write operations are in progress. If these instructions are not followed, data loss, damage to the USB stick and/or the HD 450/HD 450 Injection and/or its software may result. 40

41 Chapter 6 Logs Power switch Display Ethernet network connection (rear) USB port Inserting USB stick The USB port for the USB stick is located to the right next to the display. Proceed as follows: Insert the USB stick into the USB port. The symbol for the USB stick should now light up in the status bar. Removing USB stick Proceed as follows to remove the USB stick from the USB port. Pull the USB stick out of the USB port only when the logs have been fully written onto the USB stick. Computers as output media You can access the HD 450/HD 450 Injection directly from the network of your practice. For this, the HD 450/HD 450 Injection has to be connected via the network connection (RJ45). For exporting, you will need to use the "HD-450 Printer program, which is included. 41

42 Chapter 6 Logs HD450-Printer With this included program, you will be able to view the saved logs and print them out if desired. Installation Start the setup program on the included USB stick and follow the instructions. Initial program use When starting the HD450-Printer program for the very first time, you will have to select a printer for printing the logs. Import options You have two options to import the logs into the program USB stick: Save the logs onto the USB stick and insert the USB stick into a free USB port on the computer where the HD450-Printer program is installed. The program will recognize the log files on the stick automatically and activate the "Import" symbol. Click on the symbol to transfer the logs onto the computer. Network: If the HD 450/ HD 450 Injection is integrated into the network of your practice, it is possible to access the logs through the network. For this, you will need to select your unit in the network via the options. Click on "Download" to import. 42

43 Chapter 6 Logs Log specimen 43

44 Chapter 7 Maintenance Chapter 7 Maintenance Information contained in this chapter: How to clean the HD 450/HD 450 Injection Changing the injection filter (HD 450 Injection) Which cleaning agents are suitable How to avoid spots and stains Inspect the screens in the washing chamber daily and clean them if necessary Cleaning The fine-mesh and wide-mesh screens in the washing chamber serve to sieve out dirt particles or any remaining substances, e.g. from instruments, that have fallen into the chamber. The screens may get clogged over time. Inspect the wide and fine mesh screens daily and rinse them under running water if necessary. First, pull the injection filter upwards to remove it. Grab and turn the handle on the wide-mesh screen all the way to the left and pull upwards to remove it. Loosen and remove the fine-mesh screen and if necessary, rinse them under running water, using a soft brush to remove deposits if necessary. Do not use any dishwashing liquid. Wide-mesh screen fine-mesh screen Always ensure that both the wide-mesh and fine-mesh screens are inserted before starting a program. If these instructions are not followed, deposits may enter the cleaning cycle and negatively impact the correct functioning of the HD 450/HD 450 Injection. Inspect the washing arms daily and clean them if necessary Extremely fine particles can clog up the nozzles on the washing arms Remove the washing arms from the camber and rinse them under running water if necessary: 1. Pull on them to loosen and remove. 2. Clean extremely clogged nozzles with a thin, sharp object. 44

45 Chapter 7 Maintenance 3. After replacing the washing arm, ensure that it is able to turn freely and easily. Inspect door seal daily Nozzles of the injector system Check the door seals daily for any dirt, deposits or damage of any kind. If you notice any dirt or deposits, clean the seal with a moist, lint-free cloth and neutral common household cleaner in liquid form. To test if the nozzles of the injector system are clogged, hold them vertically under a stream of running water. If the water flows out easily through the nozzles, they are unobstructed. Front exterior of unit if required Inspect the lye pump, pump sump and the pump The control unit and the plastic exterior of the HD 450/HD 450 Injection is to be cleaned only with a moist cloth or a suitable cleaner for plastics. Please test for any adverse effects before use! Never use any solvents or benzene for cleaning. Fine dirt particles that were not trapped by the wide-mesh and fine-mesh screens and have entered the water outflow opening must be removed. This becomes apparent e.g. when the water used for cleaning is not pumped off after a program has run its course. 1. In such a situation, inspect the pump sump by removing the wideand fine-mesh screens. Remove any dirt or deposits. 2. Remove the two screws in the plastic component (use a Torx 20), pull out the plastic component and remove the dirt on the impeller wheel. After cleaning is complete, replace the blue plastic component and screw it back on. WARNING! If this happens frequently, inform an authorized representative. 45

46 Chapter 7 Maintenance Injection filter (only for HD450 Injection) WARNING! The injection filter needs to be changed every 20 cycles. This change will be indicated on the display. Use only injection filters from IC Medical. Art.-No If the injection pump malfunctions, change the injection filter and reset the counter. Menu option Admin menu/manual filter change 46

47 Chapter 7 Maintenance Cleaning the injection filter (only for the HD 450 Injection) 1. Remove the injection rail from the basic basket. 2. Remove the silicone coupling (back to the rail). 3. Remove the silicone stopper (front on the rail). 4. Overview of the required components: silicone plugs, injection rail, filter, silicone coupling 47

48 Chapter 7 Maintenance 5. Clean the injection filter under running water. For coarse dirt injection filter can be cleaned during a treatment cycle in a thermal. To do this, the injection filters in the basic basket and start a cleaning cycle. Please note that in this case no handpieces can be prepared! 6. Replace the silicone plug back on the rail. 7. Press silicon plug on and test it 8. Remove slide into the rail until the filter is completely placed in the rail. 48

49 Chapter 7 Maintenance 9. Test the position. 10. Replace the silicone coupling again. 11. guide the silicone coupling must be positioned on the frame of the filter. 49

50 Chapter 7 Maintenance 12. visual inspection whether the filter is correctly positioned. Assembly injection tube in the base rack. 50

51 Chapter 7 Maintenance Stains due to low water quality Stains due to foreign rust particles Avoiding stains Stains on instruments or in the HD 450/HD 450 Injection may be due to low water quality. To prevent stains on the instruments or in the washing chamber, we recommend that the entire rinsing be done with fully demineralized water (FD water). All parts of the HD 450/HD 450 Injection that come into contact with water are made of rust-free materials. This excludes the HD 450/HD 450 Injection as a source of rust stains. If any such rust stains appear, it is from a foreign source. It is often enough to have one rusty instrument for rust to be transferred onto the inside of the HD 450/HD 450 Injection or to other instruments. Inadequate water quality due to heavy metal or chloride contamination may lead to stains and rust. Maintenance Allow only authorized persons to perform the maintenance. (Process) Validation The operator of the practice is responsible for ensuring the error-free functioning of the cleaning and disinfection process as well as reproducible results. This is a stipulation that comes from e.g. the medical product supplier regulations (Art. 4 para. 2 MPBetreibV), the guidelines of the DGKH, DGSV, AKI and the recommendations of the Robert Koch Institute. This stipulation is also valid internationally. The basis for this is the DIN EN ISO 15883, which also applies in Germany. Please be aware of the national regulations and stipulations that apply for you. If in doubt, please contact an authorized representative. Reproducible cleaning and disinfection results can be ensured via batch checks, routine checks and/or periodic inspections (e.g. a validation). 51

52 Chapter 8 Operational breaks Chapter 8 Operational breaks Information contained in this chapter: How long you have to wait before starting the next program What you need to be aware of if the unit has not been used for a long time How to take the unit out of operation, transport it, and then put it back into operation No breaks required Breaks Breaks between individual programs are not required. After a program has completed or been canceled, the instruments can be replaced. A program can be started only after the unit has cooled to below 45 C. Taking the unit out of operation If you would like to take the HD 450/HD 450 Injection out of operation for a longer period of time, e.g. due to a vacation, proceed as follows: The interior of the washing chamber should be dry. Turn off the HD 450/HD 450 Injection at the power switch. Unplug the power plug from the socket. Turn off the water supply. 52

53 Chapter 8 Operational breaks Transportation Only authorized persons should be allowed to take the unit out of operation to prepare for transportation. When carrying the HD 450/HD 450 Injection, please note the following: Carry the HD 450/HD 450 Injection only in pairs of two persons. Should these instructions be ignored, spinal injury and bruising may result. During transportation for e.g. a move, freight or transport within a practice, please note the following: Remove the base rack and any other inserts. Remember to close the door before the unit is transported. Should these instructions not be followed, damage to the HD 450/HD 450 Injection and malfunctions may occur. Also note In addition to the instructions for taking the unit out of operation, please note the following: Empty the unit completely and seal the outlet valve. Seal the water supply hoses. Remove the base rack and any inserts. Close the door. Protection from frost The HD 450/HD 450 Injection should be operated, stored and transported in a frost-free environment. However, if there is any remaining fluid in the HD 450/HD 450 Injection that has frozen, allow the unit to stand at room temperature for 2 hours for it to thaw. Putting the unit back into operation after a move When putting the HD 450/HD 450 Injection back into operation after a move to a new location, proceed as if you were setting it up for the first time. 53

54 Chapter 9 Function test Chapter 9 Function test Information contained in this chapter: How the HD 450/HD 450 Injection automatically conducts a function test Your options for conducting a manual function test Which function tests you should carry out in daily use Process evaluation and monitoring system Automatic function test The monitoring system of the HD 450/HD 450 Injection tests the components of the unit with regard to their functionality and plausible interaction. When the parameters exceed fixed threshold values, the HD 450/HD 450 Injection will display warning messages or fault indicators. If necessary, it will cancel the program with the corresponding message. If the program has completed successfully, a corresponding message is displayed. Manual function test You have the option of monitoring the values displayed on the screen, as well as the progress of the program. Additionally, with the logs of the program, you can check if the program was completed successfully. Tests in daily use The following should be checked daily before operation: 1. Wide-mesh and fine-mesh screens in the washing chamber 2. Washing arms in the washing chamber 3. Interior of the washing chamber and the door seal 4. Baskets and inserts Also see Chapter 7 Maintenance 54

55 Chapter 10 Malfunctions Chapter 10 Malfunctions Information contained in this chapter: The different types of messages What to do in case of a malfunction What you can do before calling support What to do if nothing appears on the display Messages A message is not a malfunction. Messages serve to provide you with information and assist you in operating the unit. Warnings A warning is not a malfunction. Warnings help you ensure that the unit operates without error and to recognize undesirable situations. Pay attention to these warnings and act promptly in order to prevent malfunctions. Malfunction messages When safe operation or the cleaning and disinfection cannot be carried out properly, malfunction messages will be shown. These may appear on the display shortly after turning on the HD 450/HD 450 Injection or when a program is running. If a malfunction occurs while a program is running, he program will be canceled; this will be indicated by an audible sound. If a program is canceled before the drying phase has commenced, the washware cannot be considered to be cleaned and/or disinfected. The program must therefore be restarted. A complete cleaning and disinfection is a prerequisite for reuse and/or sterilization. Not adhering to these instructions places the health of your patients and your employees at risk. 55

56 Chapter 10 Malfunctions Before contacting us Follow the steps as indicated for dealing with a warning or a malfunction message appearing on the display of the HD 450/HD 450 Injection. In addition, you will find the most important occurrences in the following table. These situations are listed next to possible causes and the corresponding courses of action. Should you not find your situation in the table below or should the actions you take be unsuccessful, please contact an authorized representative. To better help you, please have the serial number of your HD 450/HD 450 Injection ready, as well as a detailed description of the malfunction. General situation Possible causes Recommended course of action Knocking or clattering noises in the washing chamber White deposits on the instruments Spots on the instruments Unsatisfactory cleaning results Washing arm is hitting the instruments and vessels The water softening system has not been programmed The deposits on the instruments are from the remains of dental cement Neutralization agent is missing Base rack and/or basket inserts or racks not loaded properly or too full Cancel program, rearrange washware and restart program Check the hardness of the tap water and if necessary, reprogram the water softening system Manually clean the instruments before the cement hardens Add rinsing agent Arrange washware properly according to recommended load and do not overload Arrangement leads to spray shadows Avoid spray shadows Unit does not work; there is nothing on the display Dirt and stains are too dry Verschmutzungen Washing arm nozzles or nozzles of injector rail are clogged Screens in the pump sump are dirty Unit is not turned on Power plug not plugged in Circuit breakers have tripped Do not allow dirt and stains to dry for more than 6 hours Unclog nozzles Clean the wide- and fine-mesh screens Turn on unit at the power switch Plug in the power plug Reset the breakers (see type label for min. fuse protection) 56

57 Chapter 10 Malfunctions General situation Possible causes Recommended course of action Remaining moisture on instruments Remaining moisture in hollow instruments Base rack and/or basket inserts or racks not loaded properly or too full Door was closed for a long time after program ended (see logs) Arrange washware properly and do not overload Dry instruments manually Open the door immediately after program ends. Dry narrow-necked instruments manually with sterile compressed air 57

58 Chapter 10 Malfunctions Malfunction messages Code Malfunction/warning Possible causes Recommended course of action 201 Power failure A running program was interrupted by a power failure Check the circuit breakers Program must be restarted Disinfection cannot be confirmed Do not turn off the unit at the power switch when a program is running. 202 Doors were opened Door was opened during the cleaning and disinfection process Cleaning and disinfection process was not completed! Close the doors and restart the program 203 No fresh water supply Water mains turned off, screen of supply hose clogged Supply hose pinched when setting up Turn on the mains Inspect the screen of the supply hose Check the supply hose along its length 204 Lye pump is blocked Outlet hose pinched, outlet valve or hose clogged Inspect runoff hose for bends or pinches Foreign object in the lye pump 205 No processing media found No processing media was inserted Insert Thermo Tab Program must be restarted 206 Injection pump Injection filter clogged Remove filter and inspect Insert a new filter 207 Conductivity too high The water quality in the previous wash cycle was too low Remove any remaining processing media from the unit Processing media did not dissolve completely Restart program 208 Washing arm is not turning Washing arm is blocked by washware Rearrange washware, clear clog Wash nozzles clogged Clean washing arm 52

59 Chapter 10 Malfunctions 209 Process was canceled manually Cleaning and disinfection process was stopped by user Cleaning and disinfection process was not completed! Program must be restarted 301 Overflow switch active Unit is leaking (e.g. water, wash, processing media) 302 Fresh water supplied even though inlet valve is closed Inlet valve is defective Turn off water supply! Be sure to inform specialist supplier/customer service! Fluids in the unit, e.g. in the base pan, may contain processing media in case of damage. Remember to follow the safety Immediately precautions turn off of water the processing supply! 303 Overheating Electronics are defective Contact customer service 304 Temperature too low Heating element defective Contact customer service 305 Circulation pump defective Foreign bodies in pump wheel 306 Temperature sensor - Heating element No water Temperature sensor defective Check water supply Contact customer service 307 Temperature sensor - Chamber Temperature sensor defective Contact customer service 308 Internal error Software error Missing component Turn off unit and restart Call customer service

60 Technical data Technical data Type designation HD450 HD450 Injection Measurements of unit (HxBxD) 450 x 555 x500 cm 450 x 555 x 580 cm Washing chamber (HxBxD) H= max. load height D= max. load depth 33,5 x 49.5 x 45 cm 33,5 x 49.5 x 45 cm Weight (empty) 18 kg 21 kg Floor load approx N/m² approx N/m² Volume of washing chamber Electrical connection Max. noise level (cleaning) Exhaust heat 74 liters 16 A; V; 2.4 KW 58 dba Ambient temperature C 0.55 kw/h (2.7 MJ/h) Relative humidity 30-60%30-60% Max. installation altitude Installation category 2 Air pressure 2000 m Connector for cold/fd water 3/4 75 kpa 106 kpa Waste water connector Water quality Min. flow pressure Recommended flow pressure Max. water pressure Min. washing pressure Max. waste water temperature Waste water amount per hour Power of drainage pump Length of supply and outflow hoses Length of power cord DN21 Drinking water according to drinking water ordinance (TrinkW2001); take note of local regulations. 150 kpa (1.5 bar) 250 kpa (2.5 bar) 1000 kpa (10 bar) 140 mbar 93 C (<1 min.) approx. 20 l (at small intervals) Max. 30 l/min. (volume in waste water hose) Cold water / waste water: 1.80 m / FD water supply: 1.60 m 2 m Contamination rating Category 2 Protection type (according to IEC 60529) CE-mark IP20 yes

61 Operational data Operational data Program Sump rinse Partial cycle Partial cycle Partial cycle Partial cycle Partial cycle Partial cycle Universal program -- Pre-wash 1 Pre-wash 2 Cleaning Intermediate rinse Disinfection Amount of water [l] Maintenance time [min.] Temperature [ C] <90 Drying

62 Appendix A Symbols on the unit Appendix A Icons upon the unit The icon crossed out rubbish bin marks a unit that ist not allowed to be disposed via household garbage. It has to be disposed appropriate and professional by the producer / distributor. Through labelling a unit with this icon/symbol the producer declares that he meets all legal demands regarding placing on the market, redemption and sustainable disposal of electric and electronic devices By the CE mark of conformity the producer declares that the medical devices comply with the basic demands of the Medical Devices Guidline (MDD). The 4-digit number implies the control by an authorised certification centre (here: DQS). Icon for producer. The name and complete address are straight near the icon. Purchase order number Serial number Store dry Store protected against sunlight Upper and undermost temperature limitation