User Manual MELAtherm 10 Washer-Disinfector Software version 1.309 Dear Dr. We should like to extend our thanks for the expression of trust in our company which you have displayed through the purchase of this MELAG product. As an owner-run and operated family concern founded in 1951, we have a long history of successful specialization in hygiene products for practice-based use. Our focus on innovation, quality and the highest standards of operational reliability has established MELAG as the world s leading manufacturer in the instrument treatment and hygiene field. You, our customer are justified in your demand for the best products, quality and reliability. Providing "competence in hygiene" and "Quality made in Germany", we guarantee that these demands will be met. Our certified quality management systems is subject to close monitoring: one instrument to this end is our annual multi-day audit conducted in accordance with ISO 13485 and ISO 9001 conducted by the certification agency BSI. This guarantees that all MELAG products are manufactured and tested in accordance with strict quality criteria. The MELAG management and team.
General Guidelines Please read this User Manual before you start operation of the device. The manual contains important safety information. The functionality and value-retention of this autoclave depend on the care accorded to it. Make sure to keep the User Manual close to the device. It represents a component of the product. User Group This manual is targeted at doctors, medical assistants and service. Validity This manual applies to the devices MELAtherm 10 DTA and MELAtherm 10 DTB. About these Instructions Symbols used Symbol Explanation Indicates a dangerous situation which if not avoided could entail slight to life-threatening injuries. Indicates a dangerous situation which if not avoided could entail damage to the instruments, the practice equipment or the device. Draws your attention to important information. Marking rules Symbol HEPA filter Cleaning see Chapter 2 Explanation Words or phrases marked with an arrow are explained in the glossary. The glossary is listed alphabetically. It can be found at the end of this manual. Words or phrases appearing on the display of the device are marked as display text. Reference to another text section or a figure within this manual. Symbols on the device Symbol Explanation In affixing the CE mark, the manufacturer declares that this medical product fulfils the basic requirements of the medical products directive. The four-digit number confirms that this is monitored by an approved certification agency. The symbol of the crossed out waste bin identifies a device that must not be disposed in domestic waste. The vendor is responsible for proper and professional disposal. By the designation of an apparatus with this symbol, the manufacturer furthermore declares that he satisfies all requirements of the law concerning the release, redemption and environmentally sound disposal of electric and electronic appliances.
Contents Contents Chapter 1 Performance Specifications... 6 Proper use... 6 User benefits... 6 Chapter 2 Device Description... 8 Views of the device... 9 The control panel...11 Acoustic signals...11 Overview of menus...12 Automatic door lock...13 Emergency release...13 Water softening unit...14 Chapter 3 Initial Commissioning... 15 Conditions for setting up, installing and starting up...15 Requirements to the set-up location...15 Set-up variations...16 Space requirements...16 Connections required...17 Filling the regeneration salt...17 Regeneration...18 Process agents...18 Filling the cleaning agent...19 Filling the neutralizer...19 Filling the rinse aid...20 Bleeding the metering hoses...20 Metering...21 Switching on the device...21 Preconditions for commissioning...21 Record of installation and setting up...21 Chapter 4 Cleaning and Disinfection... 22 The nature of the load...22 Hollow bodied instruments...22 Dental transfer instruments...23 Ophthalmologic instruments...23 Arranging the load...25 Observe before the program start...26 Closing the door...26 Selecting the program...26 Starting the program...27 Program run...27 Program ended...28 Manual program termination...29 Removing the load...30 Chapter 5 Logging... 31 Batch documentation... 31 Using the CF card as an output medium... 32 Computer as output medium... 33 Log printer as issue medium... 33 Automatic immediate log output... 34 Output the logs subsequently... 35 Determining the format for the program log... 35 Finding Logs... 39 Chapter 6 Settings... 40 Opening the setup menu... 40 Water supply... 40 Automatic logging... 41 Date and time... 41 Display contrast... 42 Language... 43 Water hardness... 43 Chapter 7 Function Test... 44 Automatic function test... 44 Manual function test... 44 Testing in daily operation... 44 Measuring conductivity... 44 Chapter 8 Maintenance... 45 Daily inspection/cleaning... 45 Cleaning on demand... 46 Changing the HEPA filter in the drying fan... 47 Avoid formation of spots... 48 Maintenance... 48 (Process) validation... 48 Chapter 9 Operating Pauses... 49 Pause times... 49 Shut-down... 49 Transport... 49 Re-commissioning after change of locality... 50 Chapter 10 Errors... 51 Before you call... 51 Appendix A - Accessories... 57 Technical Data... 58 Glossary... 59
Chapter 1 Performance Specifications Safety Instructions When operating the device, please ensure that you observe the following safety instructions as well as those contained in the following chapters. Purpose Use the device only for the purpose named in the user manual. Power cable and mains socket All legal specifications and electrical operating conditions of the local electricity provider must be complied with completely. Never damage or alter the plug or mains cable. Never operate the device if the mains cable or power plug are damaged. Never unplug by pulling on the power cable. Always grip the plug itself. Set-up installation and commissioning Only have the device set up, installed, and started up by people authorised by MELAG. Check the device for any damage suffered during transport after unpacking. Only operate the device in areas that are not subject to explosion hazards. The connections for electrical provision and water supply and discharge must be set-up by trained personnel. Daily operation Use only those instruments designed by their manufacturer for automatic treatment in a washer disinfector. Please ensure that you observe the information provided by the instrument manufacturers according to ISO 17664. It is especially important to observe the manufacturer's information when treating newly purchased instruments for the first time. Use only original MELAG accessories or those from other suppliers authorized for use by MELAG. When using additional accessories to accept instruments, especially hollow-bodied instruments, it is necessary to observe the information contained in the manufacturer's operating instructions. Observe the relevant standards and directives applicable to the treatment of instruments e.g. from the RKI, BfArM, DGSV, DGKH etc. as well as the treatment information from the instrument manufacturer and the AKI. The personnel responsible for instrument treatment must be sufficiently trained and schooled. The fore ventilation slits must not be covered. Only operate the device with the basis basket provided for this purpose. Process agents Handle all process agents with care. The cleaning, neutralization and rinsing aids contain irritants and even caustic substances. Use only those process agents cleared for use in a washer-disinfector and which MELAG has approved for use in this device. Observe the operating and safety information of the process agent manufacturer. If, despite observation of the manufacturer's information, the process agents have a negative effect on the material of the instruments or the device, liability lies with the manufacturer of the process agents. The use of process agents not approved by MELAG absolves MELAG of all liability whatsoever for any damage to the device or the instruments. Should you have any questions concerning the compatibility of the process agents with the instruments, please consult the manufacturer. MELAG provides information for the application of the process agents in the device but does not take any responsibility for their effects on the instruments. Any fluids in the drawer and the floor tank underneath can also contain process agents in case of damage. Ensure that you observe the information of the respective process agent manufacturer. Maintenance Have the maintenance performed only by authorised persons. 4
Chapter 1 Performance Specifications Transport and storage Install and operate the device in a frost-free environment. Store and transport the device in a generally frost-free environment. Malfunctions If repeated error messages occur while operating the device, turn the device off and notify your specialist dealer. Only have the device repaired by authorised persons. 5
Chapter 1 Performance Specifications Chapter 1 Performance Specifications In this chapter you learn The purpose for which you can employ the device What benefit you can achieve by using it The cleaning programs that are available Proper use This device is designed for application in a medical context, e.g. clinics and medical and dental practices. In accordance with DIN EN ISO 15883-1 and -2, this device is a washer-disinfector. You can subject thermo-stable medical instruments (i.e. instruments which are heat resistant to a temperature of 95 C) to automatic cleaning as long as they are suitable for this purpose. The cleaning is undertaken via the use of water and a chemical cleaning agent. Subsequent disinfection is performed by thermal disinfection. This device is not suitable for treatment of: Thermo-instable instruments, e.g. flexible endoscopes Wastes for disposal and in the lab area User benefits Universal use The device cleans and disinfects. The disinfection phase is conceived so as to reach an A0 value of at least 3000. This eliminates vegetative bacteria and fungi/fungal spores and disables viruses (inc. HBV, HCV) thus reaching the effective range AB according to the RKI directive. Active drying The device has an active drying facility. This means that after cleaning and disinfection, the instruments are dried inside (interior lumen) and out via an integrated drying fan. This enables the automatic treatment of hollow-bodied instruments such as suction cannulas. This protects the instruments from stain accretion and rusting. The additionally fitted HEPA filter guarantees drying with contamination-free air. The geometry of some hollow-bodied instruments such as turbines requires additional drying. Automatic filter recognition The device recognizes automatically that the fine filter has not been inserted in the base of the washing chamber before starting. Thus it avoids a situation in which instrument components enter the opening of the outflow pump or the circulation pump and thus restricting the function of the pumps, rinse arms and the injector rails. Internal water softening The device has an internal softening plant. The water hardness of the local drinking water is set in the device. The internal water softening unit then automatically adjusts itself to the best solution. This ensures the optimal rinsing of chlorides. Monitoring the rotation speed of the rinse arms The rotation speed of the lower and upper rinse arms is subject to permanent monitoring during a program run. This ensures that the cleaning process proceeds without hindrance and the rinse arms do not become blocked e.g. by protruding instruments in the washing chamber. Monitoring cleaning pressure The cleaning pressure is monitored during a program run via a pressure sensor. This ensures effective cleaning. Excess foam generation results in the interruption of the program run. 6
Chapter 1 Performance Specifications Metering monitoring The required amounts of cleaning agent and neutralizer are measured out using a hose measuring pump. A measurement turbine performs flow monitoring. The rinse aid is metered using a hose metering pump subject to monitoring for rotation speed. Drawer for process agents The drawer in the lower area of the device provides storage space for the process agents cleaning agent, neutralizer and rinse aid. Automatic conductivity measurement If the device is provided with DI water in the final rinse, the DI water is subject to automatic, internal conductivity measurement. CF card, Ethernet An integrated CF card slot and Ethernet interface enable secure and easy documentation of the entire cleaning and disinfection process. This is an important precondition for the clearance process. This enables the transfer of data from the device to your practice computer. Display A program can be started and settings undertaken via the two-line display with four operating keys. Motorized door lock The device is equipped with a comfortable locking mechanism which locks the door with an automatic door lock with a motorized lock. Emergency release The door can be opened manually in the case of a loss of power or malfunction using the emergency release. 7
Chapter 2 Device Description Chapter 2 Device Description In this chapter you learn Which components are included in the scope of delivery What components the device contains What safety devices the device has How the operating elements are designed and how you should use them Scope of delivery Standard scope of delivery Washer-disinfector MELAtherm 10 User Manual Technical Manual Record of installation and setting up Declaration of conformity 1 Container, 5 l 1 container for rinse aid, 1 l 1 feed funnel for the regeneration salt 1 starter package of regeneration salt Optionally Stainless steel cover plate (HxWxD 1.8 cm x 59.8 cm x 59.8 cm) Floor unit (HxWxD 40 cm x 59.8 cm x 49.8 cm) Accessories According to order 8
Chapter 2 Device Description Views of the device Front side 1. Cover plate (optional) 2. Operating and display field 3. Mains switch 4. Cover for CF card slot and Ethernet data interface 5. Door handle 6. Door, can be opened forwards 7. Drawer handle 8. Drawer for process agents, can be pulled out 9. Device front feet Back side 10. Ethernet-Data connection (rear) 11. Mains power cable 12. Connection for de-ionised water (DI water) 13. Connection for cold water (CW) 14. Effluent connection 15. Transport rollers Fig. 1: Views of the device 9
Chapter 2 Device Description Interior view 16. Connection tube for injector rails 17. Water intake cold water (CW) + DI water 18. Salt container 19. Rinse arm 20. Coarse and fine filter 21. Cooling slot (air outlet with active drying) Fig. 2: Interior view 10
Chapter 2 Device Description The control panel The control panel consists of a two-line alphanumerical LED display and four membrane keys. Keys 1 2 3 4 Key When to be used? Function/Explanation e.g. program selection Takes precedence over navigation BACKWARDS - FORWARDS, to adjust a value: SMALLER - LARGER To unlock the door or BACKWARDS, CANCEL, leave menu ENTER, OK, YES, SELECT, QUIT upon warning or error message In all display images after program interruption in the DOCU menu The system status is constantly displayed in 8 further display images with information relating to the device e.g. serial number, software version, daily and total batches etc. QUIT + DOOR, i.e. to clear the program interruption and unlock the door To delete all logs located in the internal log memory In Universal-Program Only for technicians (validation mode) Only for technicians (maintenance mode) Acoustic signals The device emits acoustic signals. The signals are designed to attract your attention and serve to inform the operator. With consecutive signals, the time between two signals amounts to 0.5 seconds. Signal Meaning 1 x 0.1 Seconds Confirms the correct operation of a key 1 x 0.5 Seconds Warning or message 3 x 0.5 Seconds At indication: Refill the salt soon; Program interruption; end of interruption reached after interruption of drying 5 x 0.5 Seconds Program completed successfully 10 x 0.5 Seconds Fault 11
Chapter 2 Device Description Overview of menus MAIN MENU P01 Universal-Program P02 Quick-Program P03 Intensive-Program P04 Ophthalmo-Program: Z01 Rinsing Z02 Emptying Z03 Reference value measurement DI Z04 Air removal Z05 Regeneration Z06 Time metering 60s M01 DOCU MENU (Output of a saved log via the following output media) Select output medium Automatic*, CF card, MELAprint, PC 01 Log list 02 Last log 03 Logs of day 04 Logs of week 05 Logs of month 06 All logs 07 Last malfunction log 08 Malfunction logs of day 08 Malfunction logs of week 10 Malfunction logs of month 11 All malfunction logs 12 Caption log 12 Status log 14 System log 15 Format CF card M02 SETUP- MENU 01 DI water 02 Automatic logging 03 Date 04 Time 05 Display contrast 06 Language 07 Water (hardness) dh 08 DIAGNOSIS + SERVICE > AC outputs (AC-OUT) > DC outputs (DC-OUT) > Analogue inputs > Counter inputs > Digital inputs SERVICE MENU Maintenance Counter Date DEMO mode 12
Chapter 2 Device Description Automatic door lock The automatic door lock guarantees the safe locking and sealing of the door during the program run. The door is locked by a motorized lock. The device must be connected to the mains and switched on in order to open and close the door. 1. In order to close the door of the device, raise the door and press it on firmly until it clicks. You can let go of the door as soon as the motorized lock activates. The door is then closed and locked automatically. 2. To open the door, press the key. This unlocks the door which now can be opened. Pull the door forward using its handle. NOTE After the program has begun, the door can only be opened by interrupting the program. Clearing the program interruption or the end of a program also opens the door. Emergency release The door of the device cannot be opened to remove the instruments during a power outage. In such a case, you can activate the door emergency release. This is located on the left interior in the lower area of the device: 1. Pull the process agent drawer out forward. A tie rod for opening the door in emergencies is located in the left front of the device interior. 2. Press the tie rod to its fullest extent until you hear a click. Pull the door open. You will require a little more force. DANGER This could release hot steam when operating the emergency unlocking mechanism. The metal surfaces are hot. There may be scalding or burns. Never operate the emergency release while a program is active. 13
Chapter 2 Device Description Water softening unit The device requires softened water for proper function. Tap water over a particular hardness (4 dh) must be softened to prevent lime scale deposits on the instruments and in the interior of the device. A water softening unit is installed to this end. Its design has been adapted to match the requirements of the device in terms of water quality and performance. Commercially available regeneration salt (NaCl) is used in the regeneration of the water softening unit, as in a dish washer. NOTE The fitted water softening unit has been optimized for a degree of hardness of 0 40 dh. For higher degrees of hardness, you will require a dedicated water softening unit. WARNING If the hardness is too high, the salt consumption will be higher. Setting too low a degree of hardness can result in lime scale deposits on the instruments. When using a dedicated water softening unit, the residual hardness of the dedicated water softening unit must also be set in the setup menu. Table 1: Water hardness conversion table dh mmol/l f e dh mmol/l f e dh mmol/l f e 1 0.2 2 2 15 2.7 27 19 28 5.0 50 36 2 0.4 4 3 16 2.9 29 20 29 5.2 52 37 3 0.5 5 4 17 3.1 31 22 30 5.4 54 38 4 0.7 7 5 18 3.2 32 23 31 5.6 56 39 5 0.9 9 7 19 3.4 34 24 32 5.8 58 41 6 1.1 11 8 20 3.6 36 25 33 5.9 59 42 7 1.3 13 9 21 3.8 38 27 34 6.1 61 43 8 1.4 14 10 22 4.0 40 28 35 6.3 63 44 9 1.6 16 12 23 4.1 41 29 36 6.5 65 46 10 1.8 18 13 24 4.3 43 31 37 6.7 67 47 11 2.0 20 14 25 4.5 45 32 38 6.8 68 48 12 2.2 22 15 26 4.7 47 33 39 7.0 70 49 13 2.3 23 17 27 4.9 49 34 40 7.2 72 51 14 2.5 25 18 14
Chapter 3 Initial Commissioning Chapter 3 Initial Commissioning In this chapter you learn Who is permitted to set up, install and start up the device The necessary preconditions for the set-up and installation The various set-up variations How to fill regeneration salt How to fill the process agents How to activate the device Conditions for setting up, installing and starting up In accordance with current VDE specifications, the device is unsuitable for operation in areas exposed to the danger of explosion. The device is conceived for use outside patient surroundings. The device should be located at least 1.5 m away (radius) from the treatment area. Observe all the information contained in this chapter during commissioning. DANGER Improper installation may lead to a short-circuit and/or fire and/or water damage and/or electrical shock. This could result in serious injury. Only have the device set up, installed, and started up by people authorised by MELAG. Requirements to the set-up location Observe the following requirements: The site of setup is dry and dust-protected. The humidity is 30 60 %. The ambience temperature is 15 35 C. There are no installations in the area of the rear of the device. WARNING Steam escaping from the device may cause damage to the adjacent furniture. During installation of the device please ensure that the adjacent base cabinets or other furniture and fittings are resistant to condensation. Observe the following safety measures when dealing with the cable and mains plug: Never splice or change the mains cable. Never bend or twist the mains cable. Never pull on the mains cable to take it out of the socket. Always take a grip on the plug. Never place any heavy objects on the mains cable. Never run the cable over areas in which it could become trapped (e.g. doors or windows). Never install the cable along a source of heat. Never use any nails, paper fasteners or similar objects to secure the cable. 15
Chapter 3 Initial Commissioning Should the cable or plug be damaged, switch off the device. The power cable and plug should only be replaced by authorised persons. If these points are not observed, the cable or plug can be damaged and/or a fire or electrical shock might occur. This could result in serious injury. Set-up variations You can set up the device in the following manner: Free-standing using the optional stainless steel cover plate. Next to pre-existing under-desk unit in conjunction with the optional stainless steel plate. Space requirements amount to a minimum of 60 cm in width and 60 cm depth. As under-desk unit in a pre-existing cavity with a work top. Free-standing with an additional floor unit and stainless steel cover plate (optional). Space requirements The under-desk unit fits into a normal 60 cm cavity next to floor-standing cupboards. The stainless steel cover plate is not required in this instance. The device is placed under a pre-existing work top. A C B3 B1 B2 D E G F Under-desk unit Free standing Top-frame device Width A 59.8 cm 59.8 cm 59.8 cm Height B B1 = 81.8 cm B2 = 83.6 cm B3 = 124 cm Depth (with display) C 67.8 cm 67.8 cm 67.8 cm D 8.2 cm 8.2 cm 8.2 cm (Without display) E 59.1 cm 59.1 cm 59.1 cm F 28.5 cm 28.5 cm 28.5 cm G 96.1 cm 96.1 cm 96.1 cm 16
Chapter 3 Initial Commissioning Connections required DANGER Improper electrical connection may lead to a short-circuit, fire, water damage and/or electrical shock. This could result in serious injury. The connections for electrical provision and water supply and discharge must be set-up by trained personnel. Also observe the information on installation and commissioning in the technical manual. Filling the regeneration salt WARNING Unsuitable regeneration salt can result in malfunctions of the water softening unit. Use only special, coarse grain regeneration salt (additive-free NaCl). Fine grain regeneration salt can cause device malfunctions. We do not recommend the use of pellets, as the salt dissolves too slowly. Never use cooking salt, table salt, de-icing salt, cattle salt or road salt. These salts usually contain insoluble components. Never pour cleaning agent or other process agents in the salt container. The regeneration salt is fed into the salt container from the salt container during the regeneration process automatically. Before the regeneration salt has been used entirely, the display will issue the message Refill salt soon at the appropriate time. A further 10 washing runs will be possible following this message, depending on the program selected and the water hardness set. If salt is not refilled during this period, the display will change to Salt storage empty Please refill! The regeneration salt must be refilled at this point at the latest, or else an error message will be issued. Then the program can no longer be started. In order to refill the regeneration salt, proceed as follows: 1. Clear the display message with the key. 2. Open the door and remove the load which may have been processed. 3. Open the salt container cap and place the funnel in the opening. 4. Before first commissioning, fill the salt container with water until it flows over so salt can dissolve in it. 5. Fill the salt container with 1 kg of regenerating salt. If there is insufficient salt in the container, the device cannot be operated. 6. Clean the edge of the opening of salt residue and any spilled brine. 17
Chapter 3 Initial Commissioning 7. Screw the cap on tightly. After filling the salt container for the first time, you do not need to add any more water. To achieve optimal capacity, we recommend always waiting for the display text Refill salt to show up after program end before refilling the salt. Also observe the following instructions on refilling the salt: It is possible to refill salt at any time, but the automatic regeneration will begin only after a particular capacity is reached. As a result, it is absolutely necessary to start the additional rinse program manually after adding salt in order to rinse away any brine or salt residue from the washing chamber. Salt residue left in the washing chamber after filling must be removed before rinsing. After refilling salt wait about 3 min. before starting a new program so that the salt can dissolve. Regeneration The water softening unit must be regenerated completely after specific intervals. This occurs entirely automatically. The regeneration will be implemented before the program selected has been carried out as soon as a program has been started and regeneration is necessary. This extends the program time only marginally. You can also regenerate the water softening unit manually by starting the regeneration program, for example, after adding salt without a warning message having been displayed. Process agents DANGER The process agents partially contain irritant or even corrosive substances that may cause health damage at contact with the skin. Protect your eyes, hands, clothing and surfaces from contact with the process agents. Every type of fluid (e.g. in the drawer, in the device floor tank or fluid emerging from the device) issued from the device as the result of damage could potentially contain aggressive process agents. Ensure that you observe the information of the respective process agent manufacturer. WARNING Unsuitable process agents can result in damage to the instruments and the washing chamber. Use only those cleaning agents intended for use with this device. Ensure that you observe the information of the respective process agent manufacturer. Use only those process agents approved by MELAG. Do not use any domestic dishwasher cleaning agents and rinse aids! Never switch suction lances for the individual process agents. Ensure that the hoses of the suction lances do not suffer kinking or crushing. Also observe the following instructions when using the process agents: When re-filling, please use the same process agents, set on the device during installation (see the tieon label on the can in the drawer). Any change in process agent in a validated device during daily operation necessitates revalidation. The product must only be changed by a trained and authorised service technician. 18
Chapter 3 Initial Commissioning Always place the canister in the drawer in such a way that the lids with the suction lances face forwards. Filling the cleaning agent Use mild alkali cleaning agents wherever possible on technical, hygienic and ecological reasons. A 5 litre canister is provided for use with the device. Only this fits in the lower drawer of the device and can be sealed by the blue screw cap and suction lance. Procedure for replacing the empty can: 1. Unscrew the suction lance from the empty canister and place it in its bracket. 2. Empty any residual contents into the new canister. Do not over-fill the new canister so that the cleaning agent is not displaced when screwing the suction lance back on. 3. Screw the relevant suction lance for the cleaning agent to the full canister. Insufficient levels of cleaning agent trigger a message on the display indicating the necessity of replacement. IMPORTANT! The metering hoses should be bleeded before commissioning (or change of product), see Bleeding the metering hoses. Filling the neutralizer In addition to neutralizing the cleaning agent, the neutralizer serves to protect the instruments and brightens their stainless steel surface. Insufficient levels of neutralizer triggers a message on the display indicating the necessity of replacement. A 5 litre canister is provided for use with the device. Only this fits in the lower drawer of the device and can be sealed with the red screw cap and suction lance. Procedure for replacing the empty can: 1. Unscrew the suction lance from the canister and place it in its bracket. 2. Empty any residual contents into the new canister. Do not over-fill the new canister so that the neutralizer is not displaced when screwing the suction lance back on. 3. Screw the relevant suction lance for the neutralizer on the canister. Insufficient levels of neutralizer triggers a message on the display indicating the necessity of replacement of the cleaner. 19
Chapter 3 Initial Commissioning IMPORTANT! The metering hoses should be bleeded before commissioning (or change of product), see Bleeding the metering hoses. Filling the rinse aid The rinse aid serves to rinse the instruments before drying. The rinse aid dries the load faster and without stain accretion. IMPORTANT! Check that your instruments are compatible for use with rinse aid. Procedure to fill the 1 litre container: 1. Unscrew the suction lance from the empty container. 2. Transfer the rinse aid from the original packaging into the MELAG 1 litre container. To ease this process, you can order a transfer spigot from MELAG 3. Screw the relevant suction lance for the rinse aid onto the container. Insufficient levels of rinse aid triggers a message on the display indicating the necessity of replacement. If the instrument surfaces are streaky this could be caused by too much rinse aid. IMPORTANT! The metering hoses should be bleeded before commissioning (or change of product), see Bleeding the metering hoses. Bleeding the metering hoses The process agent hoses need to be bleeded after filling the canister for the first time or changing a product, in order to remove any air bubbles from the metering hoses, thus guaranteeing orderly metering. To do so, start the Air removal program after filling or changing the process agents: 1. Switch on the device at the mains switch. 2. Push the key repeatedly to navigate to Z04 Air removal in the main menu. 3. Start by the program "Air removal" by pushing the key. Z04 DOOR 3 Air Removal 20
Chapter 3 Initial Commissioning Also observe the following notes: After first filling, the program "Air removal" must be started twice. If not all the process agents are to be used (e.g. no rinse aid), the free suction lance must be placed head first in the free suction lance bracket before program start (only during the program "Air removal")! Metering The concentration of the process agent is set once during the initial device setup performed by the customer services technician (see technical manual). After this, metering is performed automatically. During a program run, the preset concentration of the relevant process agents is metered automatically. Switching on the device Activate the device at the mains switch. Preconditions for commissioning The following requirements must be fulfilled for first commissioning: Water treatment unit is connected. The salt container contains sufficient salt. The cold water tap is open. The device main switch is on. The Regeneration program has been started. The process agents have been filled. The metering hoses have been bleeded. The metering has been checked in terms of the rate of supply. The basis basket is in place. Record of installation and setting up As documentation of proper setting up, installation and setting up as well as for your warranty claim, the record of installation must be filled out by the person responsible and a copy sent to MELAG. 21
Chapter 4 Cleaning and Disinfection Chapter 4 Cleaning and Disinfection In this chapter you learn What you must be aware of when preparing the load How to load the device correctly/arranging the load Which program serves which purpose How you start a program Which stages a program runs through How to cancel a program How to recognize that a program has been successfully ended What you must observe when removing the load The nature of the load You can use the device to clean and disinfect that following contents in the load. Massive instruments up to max. 10 kg Hollow articles e.g. suction cannulas which can be fixed to the hollow body nozzles or transfer instruments, e.g. hand pieces using the adapter. Hollow bodied instruments Use only the respective matching adapters for hoses and Luer systems from the accessories range of MELAG for treatment of hollow bodied instruments. They are screwed onto the injector rail and thus ensure a secure connection to the instrument and sufficient flushing. PLEASE NOTE To ensure faultless function when using three-way distributors / an injector rail, all those openings not connected to an accessory piece must be sealed with a sealing screw. Treat only those hollow-bodied instruments which guarantee sufficient and reproducible rinsing. PLEASE NOTE Ensure that the liquor used to rinse hollow instruments is secured with a filter. The reusable filter with the Order-No. 80350 may NOT be used in the treatment of ophthalmic instruments. Rule for use of filters or filter discs: Diameter of the inner lumen Insert of a filter 0.8 mm Filter necessary, e.g. three-way distributor with filter disc > 0.8 mm no filter necessary, direct connection of the adapter to the injector rail possible When treating dental and ophthalmologic transfer instrument, observe and comply with the special treatment notes contained in the following sections. 22
Chapter 4 Cleaning and Disinfection Dental transfer instruments WARNING In the case of damage or alteration to the hand pieces despite having observed the manufacturer instructions, the responsibility lies with the instrument manufacturer. Use only those turbines and hand pieces designed by their manufacturer for automatic treatment in a washer-disinfector. Please ensure that you observe the information provided by the instrument manufacturers. Suitable program The cleaning and disinfection of hand pieces in this device must be undertaken in the Universal-Program or the Intensive-Program. The Quick-Program is not approved for treatment, since contamination inside cannot be assessed. The following points must be observed before starting automatic treatment: The exterior surfaces of the hand pieces must be free of all residue e.g. dental cement. The air and spray channels must be entirely clear. Prevent dirt from drying or encrusting on and in the hand pieces. Suitable process agents Cleaning must be undertaken with a mildly alkali cleaning agent. Neutralization should be effected with a citric acid based neutralizer. Cleaning the adapter for the transfer instruments The adapter for hand pieces must be checked for dirt at regular intervals. Clean the individual adapter components under running water where necessary. The silicon inserts can be rubbed with a damp, nonfuzzing cloth. When using a filter insert, observe the cleaning or exchange intervals in the separate application notes for the MELAtherm accessories. Instrument care Leading manufacturers recommend drying the spray/air/water channels immediately after cleaning and disinfection using medical compressed air and then maintenance with suitable maintenance agents/oils. Please observe all relevant national specifications. PLEASE NOTE Do not leave the instruments in the washing chamber overnight. Soiling can become encrusted even after a rinsing program; this could result in instrument corrosion. Ophthalmologic instruments WARNING In the case of damage or alteration to the instruments despite having observed the manufacturer instructions, the responsibility lies with the instrument manufacturer. Use only those instruments designed by their manufacturer for automatic treatment in a washer disinfector. Please ensure that you observe the information provided by the instrument manufacturers. Do not treat any instruments which are used for operations of the posterior segment surgery (contact with retinal tissue, sub-retinal fluid and the optical nerve). Devices used to treat ophthalmologic instruments may only be used exclusively for this purpose. These devices are to be fitted with a suitable filter system. 23
Chapter 4 Cleaning and Disinfection Please comply with national recommendations for the cleaning of medical products under the aspect of decontamination of infectious prion proteins (vcjk). NOTE The treatment of ophthalmologic instruments requires de-ionised water e.g. by connecting the ion exchanger cartridge MELAdem 53. Suitable program Cleaning and disinfecting ophthalmologic instruments in this device requires the Ophthalmo-Program. The Ophthalmo-Program monitors the conductivity of the water from the final rinse in the disinfection phase. This ensures a defensible residual conductivity. The following points must be observed with automatic treatment: Load All hollow-bodied instruments should be rinsed using DI water and checked for passage following patient use / before automatic treatment. Instruments with recognizably reduced through-flow must be separated. All hollow-bodied instruments should be connected with the rinse bar designed for the purpose. When using a rinsing system, individual outlets which are not connected must also be sealed with suitable accessories. Ensure that plugs and / or cables from phaco hand pieces are not able to slip through the basis basket, otherwise the rinse arm can become blocked. Prevent dirt from drying or encrusting on and in the instruments. Dry the hollow articles with medical compressed air after treatment in order to remove any residual dampness. Using the device in combination with a basis basket and an injector rail enables you to treat hollow articles. You will require additional accessories to treat ophthalmologic instruments, (not available from MELAG). The operator is responsible for validating the procedure in combination with special load accessories. Especial attention is to be accorded to the feed line to the hollow-bodied instruments. Observe the manufacturer's instructions regarding the care and maintenance of the instruments/the load accessories. IMPORTANT! Cleaning should be undertaken with a mildly alkali cleaning agent. Neutralization should be effected with a citric acid based neutralizer. Never use a rinse aid. Routine checks Treatment should be followed up by blowing through the hollow articles resting on indicator paper (e.g. from Macherey-Nagel: PEHANON ph 4.0-9.0) so as to effect a routine ph value check. The indicator paper must be graduated in steps of 0.5 ph or less. In Germany, the "AK Quality: Automatic Treatment of ophthalmic instruments 2005" recommends a ph value of 5-7. Please observe all relevant national specifications. Pause times Run the "rinse" program twice before treatment following pause times longer than two days e.g. following a weekend. 24
Chapter 4 Cleaning and Disinfection Arranging the load DANGER Charging of sharp or pointy instruments may cause injuries at improper procedures. Take care when arranging sharp and pointed instruments and do so in a manner that prevents all danger of injury. Loading should best be performed from back to front. We recommend wearing protective gloves. Baskets and perforated cartridges with wire meshes or other openings do not provide any protection against penetration by sharp instruments. To arrange the load, the basis basket should be used as a minimum. This is available with an additional injector rail for treating hollow bodied instruments. Other accessories such as an insert rack, and instrument basket, wash trays and perforated cartridges and instruments are always to be placed in the basis basket. The basic basket is correctly inserted into the washing chamber when the blind flap or the injector rail is located on the right side and docked to the connection tube of the rear wall of the washing chamber. Fig. 3: Look into the washing chamber. Further accessories and their user instructions such as insert rack for washing trays, perforated cartridges and instrument baskets etc. are listed in the separate application notes for the accessories. Observe the following instructions when classifying the load: Empty residual liquids from containers before placing them in the cleaner and wash away any critical fluids e.g. disinfection solutions. Individual instruments must be placed in baskets or trays and never in the basis basket directly. Instruments may not be allowed to protrude from the sides of the instrument basket. Otherwise, these could damage the door seal or side walls of the washing chamber. Instruments may not be allowed to hang through the bars of the basket at the base. Otherwise, the surface of the door could become scratched or parts of instruments could break off. Hollow-bodied instruments must be placed in the device so that secure flushing is warranted. If required, use accessories developed specially for processing of hollow-bodied instruments, e.g. injector nozzles, Luer connections, etc. See separate application notes for the MELAtherm accessories. Transfer instruments must be set on one of the adapters with silicone insert. The rinse arms must be allowed to revolve freely and may not be blocked by protruding or hanging instruments. A good cleaning outcome depends on the correct arrangement of the instruments. Spray shadows are thus to be avoided. Instruments may not be allowed to cover each other. All containers such as glasses, basins etc. should be arranged with their opening pointing downwards. Components with openings or compressions should be arranged at an angle, so that the water can run off them. 25
Chapter 4 Cleaning and Disinfection Use only cleanable instruments made of instrument steel in order to avoid corrosion. Use plastic components with thermostability up to 95 C. Observe before the program start Ensure compliance with the following prerequisites in order to secure the optimal cleaning performance before every program start. The nozzles of the upper and lower rinse arms must be freely accessible and clean (see Chapter 7 Function Test). The load must be arranged correctly. The rinse arms can be turned freely. For reasons for safety, the speed is monitored continually during the program course. The coarse and fine filter is clean or was cleaned on demand. The nozzles and adapter of the injector rail must be clean (see Chapter 7 Function Test). The canister with the process agents must be sufficiently full; a warning message could be issued before the program start indicating the necessity of refilling. Closing the door To close the door, fold the door upwards and press it until the motorized lock sets in. The door can be unlocked and opened at any time before the program start using the key. Selecting the program You can switch between the programs using the key. Choose the program according to the level of soiling of the load. The Universal-Program is sufficient for every-day general usage. The Quick-Program is designed for lightly-soiled instruments. The following table lists the correct program for each load. Program Nature of instrument/soiling Operating time* (plus drying time) Universal-Program 90 C, 5 min. Quick-Program 90 C, 5 min. Intensive-Program 90 C, 5 min. Ophthalmo-Program 90 C, 5 min. For normal-heavily soiled instruments. This complies with the general hygiene-related requirements of DIN EN ISO 15883-1. For non- or slightly soiled instruments. As with the Universal-Program but without the pre-wash. Not suitable for hollow bodied instruments (e.g. extraction cannulas, hand pieces, turbines, cannulas) For particularly heavily soiled instruments like the Universal-Program, but with a longer cleaning time For normally contaminated ophthalmology instruments, like the universal Universal-Program, but with a longer cleaning time, double intermediate rinsing without rinse aid DTA DTB 36 Min. 53 Min. 30 Min. 47 Min. 40 Min. 57 Min. 42 Min. 59 Min. **The operating times represent average values and apply only for the recommended running water pressure at a cold water temperature of 15 C. 26
Chapter 4 Cleaning and Disinfection Auxiliary programs Application Rinse, 3 min, no disinfection For soaking instruments with encrusted dirt, for rinsing strongly contaminated instruments, e.g. following soaking in disinfection solutions (to avoid increased foam generation) for washing out the chamber after salt refill; without process agents, no disinfection. Operating time 3 Min. Emptying Pumping out residual water in the washing chamber 1 Min. Reference value measurement DI Air removal For measuring the conductivity of the DI water Bleeding the metering hoses upon commissioning, maintenance, changing the process agents, product change etc. 2 Min. 5 Min. Regeneration Regenerating the internal water softening unit 8 Min. Time metering Only for technicians **The operating times represent average values and apply only for the recommended running water pressure at a cold water temperature of 15 C. Starting the program WARNING The unauthorised operation of this device may cause damage to the device or the facility. MELAG does not accept any liability for such damage. Never operate the device unattended. Unsupervised operation of electrical devices, including this device at the operator s risk. After selecting a program using the the temperature and holding time. key, in addition to the program selected, the display also indicates P01 DOOR 3 90 C 5min Universal-Program To start a program, press the key. Program run After starting the program, you can follow the program run in the display. The program steps are indicated on the display during the program run. Pre-cleaning Pre-cleaning is performed with softened water and without process agents. It is temperature controlled. Coarse encrusted organic material is subject to mechanical dissolution. All proteins on the instruments must be removed entirely. It is necessary to avoid denaturation resulting from too a high water temperature. Cleaning The actual cleaning is performed here. The washing chamber is heated until reaching the program-specific temperature. This is then held during the holding time. The cleaning agent is added automatically before the holding time begins. Neutralization If neutralization is necessary following cleaning, the neutralizer is added before circulation in order to reduce the alkalinity and to free the instruments of acid-soluble deposits such as lime scale and extraneous rust. 27
Chapter 4 Cleaning and Disinfection Intermediate rinsing Intermediate rinsing is a preparatory step to disinfection to reduce the residual concentration of the process agents. Disinfection Thermal disinfection with water takes place here. Drying The instruments are then dried by the integrated drying fan from inside and out. This prevents rust accretion on the instruments. Instruments with a low inner diameter must be subsequently dried. Follow the program run on the computer You can follow the current progress of a current cleaning program in a web browser on every computer of the user network via the website integrated in the device. The device must be assigned an IP address and is connected to the user network. 1. Open a web browser window (we recommend Mozilla Firefox or Internet Explorer). 2. Enter the address of this device on the user PC in the address bar of the web browser, e.g. 192.168.57.41 and confirm with ENTER. You can now view the program run or information regarding your device such as the serial number or device software version. Fig. 4: Example of a view in the web browser Program ended The display message indicates when and whether a program has ended successfully. Universal-Program successfully ended To open the door after the program end, press the key. 28
Chapter 4 Cleaning and Disinfection This is how you control the cleaning outcome after the end of cleaning. Instruments must be completely clean and dry. Hollow body articles are still fixed. If they were not, they would need to be treated again. The interior of the hollow bodied instruments (lumen) are still freely accessible. The injector rail still sits snugly on the connection tube in the washing chamber. The nozzles and connections to the basis basket are still connected. When all these provisions have been satisfied and the program has run without interruption, or malfunction, the load has been cleaned and disinfected. NOTE Open the door immediately after the end of the program to prevent the accretion of condensation. NOTE Hollow bodied instruments with a narrow internal diameter are to be dried subsequently with air. Displaying the batch counter The display shows the last batch number run and the total batch counter after a program end or the end of a program abort. Universal-Program Day: 4 Total: 106 Manual program termination WARNING Cancellation of a current program by deactivation at the mains switch may cause damage at the device. Never abort a program by switching off at the mains. Manual termination during drying WARNING If a program is aborted during drying, residual dampness will remain on the instruments. The instruments should be dried manually. You abort a current program only in exceptional cases. DANGER The washing chamber and the instruments are still very hot in this program step. There is a danger of scalding. Let the washing chamber cool out a little before removing the instruments. The door can be opened as of a temperature of < 88 C If a program is aborted during drying the program is classed as having been ended successfully. 29
Chapter 4 Cleaning and Disinfection Proceed as follows to abort the program during drying: 1. Wait until the display shows the following message. Universal-Program CANCEL DRYING 4 1. Press the key to abort the program. Confirm the abort with YES. 2. After a short time, you can open the door by pressing the + keys simultaneously. The display contains information on how to do this. Manual termination before beginning of drying WARNING If a program is interrupted before the start of a drying phase, the program is deemed not cleaned and disinfected. There may be a danger of contamination. The program will then need to be restarted. You abort a current program in exceptions. It is thus important to exercise extreme caution in dealing with instruments. The instruments can still be very hot if the door is opened after a program abort. Press the display. keys to abort a current program before drying begins and follow the information on the Universal-Program CANCEL 4 Removing the load DANGER The device may be damaged at improper opening of the door and/or steam may escape from use of disinfectants. Never use force to open the door. DANGER Especially massive instruments can be very hot after the program end. Therefore, there is the danger of scalding or burns. Allow the instruments, baskets and insert racks to cool before removing them. 30
Chapter 5 Logging Chapter 5 Logging In this chapter you learn Why and how you document batches Which output media you can employ for the batch documentation Where you can find the logs for the batch documentation How to read logs correctly Batch documentation The batch documentation acts as proof of the successful conclusion of the cleaning and disinfection process and represents an obligatory part of quality assurance ( MPBetreibV). The data, such as type of program as well as batch and process parameters of the completed programs, are stored in an internal log memory of the device. For the batch documentation you can transfer the internal log memory readout and the data onto diverse output media. This can be performed at the end of every program or at a later point, such as at the end of the day. Internal log memory The capacity of the internal log memory is sufficient for approx. 30 logs. If the internal log memory becomes full and at least one log has not been issued via an activated medium, the following warning will appear on the display: Internal program log is full. Not all logs issued. The appearance of this warning represents the last possibility to save the unissued log before the oldest logs are deleted and overwritten. Select the required output medium in the setup menu and issue the relevant log. Output media You are able to issue and archive the logs of the completed programs on the following output media: MELAflash CF card A computer in a user network (LAN). Log printer MELAprint 42 with network adapter Any combination of the output media is possible. Thus it is possible both to save logs on the MELAflash CF card and print them on the log printer. As delivered, the MELAflash CF card is set as an output medium in the setup menu and thus the automatic log issue at the end of a program (Immediate issue = YES) is thus activated. Log issue on multiply activated media is performed successively. If you wish to retain this state, following commissioning of the device, the relevant log will be issued on the CF card and saved there as soon as a program ends (immediate issue = YES). To do this, the CF card must be inserted in the slot of the device (see the next section Using the CF card as an output medium). 31
Chapter 5 Logging Using the CF card as an output medium WARNING When the CF card is pulled from the card slot prematurely or if it is treated improperly, data loss, damage to the CF card, the device and/or its software may occur. Never push the CF card in the slot with force. Never remove the CF card from the slot whilst it is being written or read. The red LED next to the card slot on the right will illuminate red in short irregular intervals during reading and writing access. NOTE The CF card cover cap must remain closed during operation. Inserting the CF card The card slot for the CF card is located behind the cover cap on the right, adjacent to the door below the main switch. Proceed as follows in order to insert the CF card in the slot. 1. Open the CF card cover cap (6) downwards 1. Mains switch 2. Card slot for the CF card 3. Ethernet-Data connection 4. LED 5. CF card ejection switch 6. CF card cover cap Fig. 5: Card slot for the CF card 2. With the raised finger edge pointing leftwards, place the CF card in the card slot (2). 3. Push the CF card in the card slot until it clicks. When the CF card has been placed correctly, the red LED (4) to the right adjacent to the card slot will illuminate shortly. 32
Chapter 5 Logging Removing the CF card Proceed as follows in order to remove the CF card from the slot. 1. Watch the LED to the right of the card slot. The red LED illuminates red in irregular intervals when a log is being saved on the CF card. If this is the case, wait until the LED has extinguished. 2. Press the ejection switch (5) underneath the card slot and remove the CF card. 3. Return the cover cap (6) to its starting position. Computer as output medium You can connect a computer to the device directly or over a network when the following prerequisites are met. The computer has a network cared with a RJ45 socket (LAN). An FTP server or a FTP service is installed on the computer (when the log is issued via FTP). A suitable program, e.g. MELAview, is installed (when the log is issued via TCP). Log printer as issue medium If you want to use the log printer MELAprint 42 as an output medium, connect it to the device with the network adapter (not in the scope of delivery of the MELAprint 42 order no. 40295): 1. Plug (1) in the socket. 2. Connect the MELAG network adapter (3) with the supplied cable (2) to an Ethernet data connection point of the back of the device (see page 9, Fig. 1). 3. Plug the MELAG network adapter (3) into the serial connection of the log printer MELAprint 42 (can be screwed). 4. Connect the cable (4) of the adapter (3) to the log printer electricity supply jack. 5. Switch on the device at the mains switch. 6. Now switch on the log printer. 7. Switch the device off and on again now. In doing so, the device sends the IP address saved in the device as a parameter to the network adapter and saves it. 1. Power supply 2. Connection cable 3. MELAG-Network adapter 4. Adapter cable NOTE If the above steps are unsuccessful, the IP addresses saved in the device and those of the MELAprint 42 probably do not belong to the subnet, since the factory settings were changed. 33
Chapter 5 Logging Automatic immediate log output Text logs If you want to issue the relevant log automatically immediately after the end of a program, use the option with immediate output = YES in the SETUP-MENU 02 Automatic Logging. The following requirements must be fulfilled in order to issue text logs immediately after the end of a program. In the setup menu 02 Automatic logging, immediate output is set to YES. In the setup menu 02 Automatic logging, at least one output medium is selected and 02 Automatic logging is thus set to ACTIVE. The activated output medium has been connected (e.g. log printer MELAprint 42) or the CF card has been entered. When automatic log output is not possible, e.g. because the activated output medium is not connected, the text log is stored in the internal memory. It is not lost. A warning message appears. The device registers as yet not issued logs for every output medium. It provides the option of issuing this log at the next possible opportunity. It is recommended using automatic logging with an immediate log output. If you want to issue the associated text logs automatically after the end of a program on the output medium set on 02 Automatic Logging, must be set to YES. As delivered, the device is set to automatic log output of the text logs via the CF card, immediately after the program has ended. Graphics Logs (optional) The following additional requirements must be fulfilled in order to record graphic logs: In the SETUP-MENU 02 Automatic logging Graphics logs, at least one output medium is set to YES. At least one of the output media selected corresponds to an output medium for the text log. The activated output medium is connected, e.g. computer, or the CF card has been plugged in. Explanation of the possible settings for graphic log recording: Graphics & CFC In the menu Graphic Log Graphic+CFC or Graphic+Comp, select the output media on which the graphic log is to be saved. At least on of the two output media must correspond with the medium selected for the output of text logs. 01 Graphic Logs Graphic+CFC YES CFC-Interval CFC interval or PC interval indicates the time intervals in which the program curve is recorded on the CF card or computer. The smaller the time interval, the more exact the curve. In the example, the time interval is set at 1 second. 03 Graphic logs CFC interval 00001 34
Chapter 5 Logging PC-backup PC backup indicates the time interval in which the graphic logs are to be saved on the computer by the device. In the example, the backup interval is set to 30 seconds. 05 Graphic logs PC-backup 00030 NOTE Graphic logs cannot be saved in the internal log memory. If you wish to record optional graphic logs in addition to the text logs, please always ensure that at least one common output medium has been set for issuing text and graphic logs. This means that at least the computer or the CF card should correspond as output medium for both log types. Output the logs subsequently The docu menu provides the option of issuing logs subsequently and independently of the point of the program end. You can use the output media activated for the log automatic in the SETUP MENU 02 Automatic logging or any other output medium. 1. Push or to navigate in the main menu to DOCU-MENU. 2. Push to open the Docu menu. 3. Push repeatedly to select the desired output medium. If you want to assume the settings from the menu Automatic logging, select the option automatic. 4. Push to get to the option log type. 5. Push to choose between the log types, e.g. last log, log of the day, etc. 6. Push the in order to start the log output. Delete saved logs In order e.g. to suppress the warning text Protocol memory full for preset option Immediate output NO, the saved logs can be manually deleted as follows: 1. Push or to navigate in the main menu to DOCU MENU. 2. Push to open the Docu menu. 3. Push to get to the option log type. 4. Push to navigate to 06 All logs. 5. In order to delete all logs, confirm the query by holding they keys +. Determining the format for the program log A log is saved in the internal log memory for every program run. The log format enables you to determine which of the data saved should be issued. You can choose between the format (0001) and the more comprehensive format (0002). The log format (0002) is the standard format. The log format is saved in the program log in the setup menu (see page Chapter 5 Logging). 35
Chapter 5 Logging Log format 0000 0001 0002 Content 0000 0001 0002* Header X X X Program step values X X Key X * Standard format Header The header comprises lines 15 to 83 and contains the most important information on the elapsed program (see Fig. 6). Information on the device, such as serial number, current software version of the firmware, parameter and operating interface is issued as well. Program steps During the program, the program steps are recorded together with the associated values for temperature, time, consumption of process agents, the cleaning pressure, the volume of cold water and DI water, the conductivity as well as the start and end times. Upon the incidence of a malfunction, row 92 issues warnings and error messages. The end of the log displays the proof of validity and program-specific values in code. Key The key is a component of the log format 0002. It serves to mark the program steps to which the values given relate. In digitally outputted logs ( CF card, PC) the key is located directly next to the values of the respective program step. In logs issued via the log printer MELAprint 42, the row containing the key is always located under the row to which it refers. 36
Chapter 5 Logging Log types In addition to logs for successfully completed programs, there are many other types of log. These can be issued via the list in the Docu menu. You can identify the log type by the ending of its file name. Ending Stands for Explanation PRO Program log Log of a successfully completed program GPD Graphic log The log in which the process is recorded graphically STR Malfunction log Log of an aborted program STB Malfunction in standby Log with malfunctions without a program having run LOG System log List of all the faults and changes to the system in order of time (log book) STA Status log Summary of all the important settings and system states (counter, measurement values etc.) + a list of all procedure-relevant parameters (VRP) LEG Caption log Contains all step abbreviations used in the program log DEM Demo log Log of a successfully completed simulated program in DEMO mode (only for presentation purposes) DES Demo malfunction Log of a program simulated as interrupted (presentation) 37
Chapter 5 Logging ---------------------------------------- 10 MELAG MELAtherm 10-DTA ---------------------------------------- 15 Program : Universal-Program 20 TARGET C min 21 Pre-clean: 22.0 01:30 23 Cleaning : 55.0 07:00 28 Disinfect: 90.0 05:00 30 Date : 10.06.2013 35 Batch : Day:01 Total:03240 ===== 40 Program successfully ended 42= ====== 50 ACTUAL C +/- K min 51 Pre-clean: 27.0 +0.1/-0.1 01:30 53 Cleaning : 57.6 +1.4/-0.6 07:00 58 Disinfect: 92.1 +0.1/-0.1 05:00 4007 ------ 60 Conduct. : 13.6 (---) µs/cm 65 Start : 12:56:58 70 End time : 13:56:45 (59:47 min) ====== 80 SN:201010-DTA1006 ====== 81 Firmware : V1.309 01.03.2013 82 Parameter: V1.309 25.01.2013 83 BO : V1.305 25.01.2013 ---------------------------------------- Step Start End Time C ml mbar --> Process start S1X01 0:00 0:00 0:00 24.8 ---- --- --> Pre-cleaning V1E01 0:00 0:03 0:03 24.8 ---- --- V1P01 0:03 0:07 0:04 24.8 ---- --- V1S12 0:07 0:13 0:06 24.8 555 --- V1P06 0:13 0:23 0:10 24.8 ---- ---.. --> Cleaning R1E02 4:13 4:16 0:03 27.1 ---- --- R1P01 4:16 4:20 0:04 27.1 ---- --- R1S02 4:20 5:06 0:46 23.4 5555 --- R1H02 4:20 6:21 2:01 39.8 ---- --- R1U03 4:20 6:21 2:01 39.8 ---- 295.. --> Neutralizing N1E01 15:36 15:40 0:04 56.5 ---- --- N1P01 15:40 15:44 0:04 56.4 ---- --- N1S03 15:44 16:27 0:43 32.3 5055 ---.. --> Intermediate rinsing Z1E02 17:54 17:55 0:01 34.0 ---- --- Z1P01 17:55 17:59 0:04 34.1 ---- --- Z1S04 17:59 18:41 0:42 23.0 5060 ---.. --> Disinfecting D1E02 20:01 20:01 0:00 24.4 ---- --- D1P01 20:01 20:05 0:04 24.4 ---- --- D1S05 20:05 20:51 0:46 27.0 5055 --- D1H08 20:05 20:52 0:47 27.1 ---- --- D1U03 20:05 20:52 0:47 27.1 ---- ---.. --> Drying T1E01 34:02 34:05 0:03 91.1 ---- --- T1K07 34:02 34:22 0:20 91.0 131 --- T1E01 34:22 34:32 0:10 90.8 ---- --- T1K07 34:22 34:48 0:26 90.2 131 --- T1E01 34:48 35:00 0:12 90.0 ---- --- T1T04 34:48 37:57 3:09 82.3 ---- ---. --> Process end E1Z01 59:39 59:47 0:08 40.0 ---- --- 92-------------------------------WARNING >Event Step Time Hint 10 Name of the device 15 20 21 23 28 30 35 40 42 50 51 53 58 60 65 70 80 81 82 83 Program name TARGET Value: Temperature and holding time of the partial cycles Date Day and total charge number Control message Program abort, if program unsuccessful ACTUAL-value: Temperature (range) in C, holding time of the partial cycles. ACTUAL value Temperature conditions of the disinfection, A0 value Conductivity of the DI water for the final rinse Time at the start of the program Time at the end of the program (Program length) Device serial number installed firmware version installed parameter version installed operating interface Program step values and key Time Time (mm:ss), since the program start min: Duration (mm:ss), of a program step C Temperature of the rinse liquor in the washing chamber in Celsius ml Volume of CW/DI water, the process agent consumed during a process step. mbar Rinse pressure 92 95 Up to a possible 5 warnings Fault numbers upon program interruption ---------------------------------------- >> Never change code in following row << 530000ED001D000D67EF0E0A030004AD00000000 >> Proof of authenticity batch log << ---------------------------------------- Voltage max/min: 238/227 CW:25.4 DI: 5.0 0.0 0.0-0.00 0.0-0.00 --et1---et2----eps----etu----epx---end-- Fig. 6: Example of a program log for a successful finished Universal-Program Proof of authenticity May never be altered; indicates that the data was generated on a MELAG device and has not been changed. Sensor measurement values are displayed in the case of a malfunction. The values are helpful for a technician. 38
Chapter 5 Logging Finding Logs All memory media ( CF card or computer) contain a directory with the encoded serial number of the device concerned following log output. The folder name consists of five characters identical with the first five characters of every log, e.g. CR0ZH. The directory contains sub-directories containing the month of the log generation e.g. 01_2013 for January 2013. These contain all the logs generated by device in this month. The device directory is entered in the main directory on the CF card. The device checks the memory medium after every type of log output (immediate output after a completed cycle or the transfer of multiple logs simultaneously). Should a directory not exist, it creates one of a device and a month. If logs are issued on the same memory medium more than once, a duplicated" directory will be created under the device directory in which these logs will be saved only once. NOTE If possible, do not rename the directory otherwise logs will be stored in both the renamed directory as well as the device directory generated automatically by the device. Direct transfer of the log to a computer via the network and using the MELAG FTP server allows you to determine directly in the FTP server where on your computer the device directory with log files is to be saved. When issuing via TCP and e.g. MELAview, you also determine the filing folder right in the program. 39
Chapter 6 Settings Chapter 6 Settings Opening the setup menu 1. Push to navigate in the main menu to M02 SETUP MENU. M02 SETUP MENU 1. Push to open the setup menu. 2. Push to leave the setup menu. 3. Push the in order to save the change or 4. Hold in order to discard the change. DISCARD 3h SAVE 4 Water supply If a DI connection is available for the device, e.g. the MELAdem 53 or another water treatment unit is connected, this must be set on the device. In its delivery state, the water supply has been set to DI water YES. To alter this setting, proceed as follows: 1. Open the setup menu as described above. This display registers the option 01 DI water YES. 01 SETUP MENU DI water YES 2. Push in order to change the option. The value YES flashes. 3. Push or to switch between YES and NO. 4. Push to save the new value. The value no longer flashes. 5. Push to leave the setup menu (see above). 40
Chapter 6 Settings Automatic logging Menu 02 Automatic logging is used to undertake all settings concerning the issue of logs and which are to be made only once. Examples include the choice of output media, activating the immediate output, log format etc. All future program logs will always be issued from the respective output media using the settings made here. The display image shows whether the option for log output is ACTIVE or not. 02 SETUP-MENU Autom. logging ACTIVE Detailed information on logging is found in Chapter 5 Logging. Determining the output medium In menu 02 Automatic Logging, the selectable output media are displayed one by one, e.g. CF card, computer, MELAprint, etc. 1. Push repeatedly to navigate in the setup menu to 01 CF-Card YES. 01 Automatic logging CF card YES 2. The display of YES indicates that the log is to be saved on the CF card. If a log is not to be saved on the CF card the setting must be changed to NO. 3. Push to change the value. The value YES flashes. 4. Push or to switch between YES and NO. 5. Push to save the new value. The value no longer flashes. 6. Push to leave the setup menu (see above). 7. Proceed in a similar manner to set a different output medium. Determining log format Detailed information on the log formats 0001 and 0002 can be found in Chapter 5 Logging. Date and time Date and time of the device must be correctly set for proper batch documentation. Observe the time resettings in autumn and spring ("daylight saving time"), since this is not reset automatically Setting the date Set the date and time as follows: 1. Push repeatedly to navigate in the setup menu to 03 Date. 03 SETUP MENU Date 12.01.2010 41
Chapter 6 Settings 2. Push to change the date. The display changes to 03 Change date. 03 Change date Day 12 3. Push repeatedly to choose between day, month and year. 4. Push to alter the parameters selected, e.g. the day. The current value flashes. 5. Push or to reduce or increase the value. 6. Push to save the new value. The value no longer flashes. 7. Push to change the month next. Proceed accordingly. 8. Push to leave the setup menu. Setting the time To set the time, proceed as described in the previous section Setting the date. 04 SETUP MENU Time 13:45 Display contrast 1. Push repeatedly to navigate in the setup menu to 05 Display contrast. 05 SETUP MENU Display contrast 2. Push to change the contrast. 3. Push or to reduce or increase the contrast. 4. Push to save the settings. 5. Push to leave the setup menu. 42
Chapter 6 Settings Language The device offers a selection of two languages. You can select the language in the setup menu. Language 1 is usually the local language, Language 2 is English. 1. Push repeatedly to navigate in the setup menu to 06 Language. 06 SETUP MENU Language 0001 2. Push in order to change the language. The current value flashes. 3. Push to change to language 002. 4. Push to save the settings. 5. Push to leave the setup menu. If you wish to set a language other than those installed on the device, you must perform a language update from the CF card with the appropriate language file. Please consult your MELAG customer services/stockist. Water hardness 1. Push repeatedly to navigate in the setup menu to 07 Water dh. 07 SETUP Menu Water dh 20.0 2. Push to change the value. The value flashes. 3. Push or to reduce or increase the value. 4. Push to save the new value. The value no longer flashes. 5. Push to leave the setup menu (see above). You can find a water hardness conversion table on page 14. 43
Chapter 7 Function Test Chapter 7 Function Test In this chapter you learn How the device automatically carries out the function test Which possibilities you have for the manual function test Which function tests are to be conducted in daily operation How to display the water quality Automatic function test The monitoring system of the device checks the device components with regard to their functional reliability and their plausible interaction. If the parameters exceed defined limit values, the device outputs warning messages or error messages. If necessary, it interrupts the program with a corresponding notice. If the program was successfully concluded, an appropriate message is issued on the display. Manual function test You can follow the program run on the display via the values displayed there. You can also use the logs recorded for every program to determine the success of a program (see page Chapter 5 Logging). Testing in daily operation Check the following items every day before work starts: Coarse and fine filter is inserted Rinse arms are free The interior of the washing chamber and the door seal are undamaged Baskets and inserts are inserted correctly Follow the instructions in Chapter 8 Maintenance as well. Measuring conductivity You can access the water quality of the DI water on the device on the display at any time providing, that it is switched on. To do so, start the supplementary program Conductivity DI" with the key. Z03 DOOR 3 MEASURE 4 Conductivity DI 44
Chapter 8 Maintenance Chapter 8 Maintenance In this chapter you learn How to clean the device Which cleaning agents are suitable for this purpose How to avoid the formation of spots What to observe in device maintenance Daily inspection/cleaning Inspection of the filters in the washing chamber The coarse and fine filter in the base of the washing chamber serves to hold back dirt particles or residue which has been cleaned from the instruments. As a result, the filters can become blocked over time. Check the coarse and fine filter on a daily basis and where necessary, clean it under running water: 1. Turn the coarse filter all the way to the left by the handle and remove upwards. 2. Loosen the fine filter by turning the knurled nut, take it out and flush the two filters under running water if required. Remove deposits with a soft brush if required. Do not use any detergent. WARNING When the coarse and fine filter is not inserted, residue may enter the flushing circuit and impair the device function. Ensure that the coarse and fine filters are always in place before program start. Checking the rinse arms Fine dirt particles can block the nozzles of the rinse arms. Therefore, the rinse arms have been taken out and the nozzles may be flushed under running water. 1. Loosen the curled nut by turning and remove the upper and lower rinse arms upwards and downwards respectively. 2. Clean very blocked nozzles with a thin pointed object. 3. Return the rinse arms and ensure their free movement. 45
Chapter 8 Maintenance Checking the door seal Check the door seal for impurities, deposits or damage on a daily basis. Clean any impurities with a damp, non-fuzzing cloth and a commercially available neutral liquid cleaning agent. Inspection of passage of the nozzles of the injector rail To test whether the nozzles on the injector rails are blocked, they must be held upright under running water. If the water flows through freely, then the nozzles are not blocked. Cleaning on demand Outer front of the device The operating unit and the plastic front of the device should only be cleaned using a damp cloth or a suitable plastic cleaning agent. Check the material compatibility before application! Never use cleaning agents or benzene. When using area disinfectants, observe that they are suitable for plastic. Observe the manufacturer's information on the respective disinfectant. Pump pit and non-return valve Any fine particles having passed through the coarse and fine filter into the water cycle should be removed. This is observable if the flushing water cannot be pumped away after a program has finished. 1. To do so, check the pump pit 1 by removing the coarse and fine filter beforehand. Remove any residue/deposits. 2. Pull the non-return valve upwards and remove it from the pump pit. If necessary, clean it under running water. 3. If necessary, start the rinse program to wash away any particles thus removed. NOTE Should this occur repeatedly, inform your stockist or MELAG customer services upon the next maintenance interval. 1 The pump pit is the plastic container below the coarse and fine filter by which the water is recirculated. 46
Chapter 8 Maintenance Changing the HEPA filter in the drying fan Exceeding the permissible level of blockage can result in a worsened drying outcome. For this reason, the device checks the degree of blockage automatically. Exceeding the tolerances results in the issue of the relevant display message. 1. Pull the drawer outwards. 2. Loosen the bayonet cap on the cover cap by turning it and lift up the cover cap. 3. Pull out the pre-filter upwards and replace it. 4. Take out the HEPA filter upwards and replace it. 5. Replace the cover cap and fasten the bayonet cap. DANGER Careless touching of the HEPA filter may damage the lamellae. This may impair filter services and recontamination of the disinfected instruments. Only touch the HEPA filter by the frame and do not damage the lamellae. NOTE The pre-filter and HEPA filter must be changed yearly (e.g. during maintenance). 47