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Summary of Contents for Durr Dental Hygoclave 90
- Page 1 Hygoclave 90 Installation and Operating Instructions 0297 6046100064L02 ...
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Page 3: Table Of Contents
10�2 Bowie-Dick test � � � � � � � � � � � � � � 27 5�1 Hygoclave 90 � � � � � � � � � � � � � � � � 11 11 Logging handover and installation � � � � 28 5�2... - Page 4 Contents 13�6 Preparations for steam sterilisation � � � � � � � � � � � � � � � � � � 34 13�7 Loading the items for sterilisation into the unit � � � � � � � � � � � � � � � � � � 36 13�8 Steam sterilising �...
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Page 5: Important Information
Important information About this document Other symbols These symbols are used in the document and These installation and operating instructions on or in the unit: form part of the unit� Note, e�g� specific instructions regarding If the instructions and information in efficient and cost-effective use of the unit�... -
Page 6: Safety
Important information Safety NOTICE Damage to the unit or to the items Dürr Dental has designed and constructed this being sterilised due to unsuitable device so that when used properly and for the materials intended purpose there is no danger to people Only sterilise instruments, packaging or property�... -
Page 7: Qualified Personnel
Important information 2.6 Qualified personnel 2.10 Disposal Operation Unit Persons who operate the units must ensure safe The unit may be contaminated� Instruct and correct handling based on their training and the company disposing of the waste to knowledge� take the relevant safety precautions in Instruct or have every user instructed in han- this case�... -
Page 8: Product Description
Product description Overview Steam steriliser Hygoclave 90 Sterile air filter SD memory card Network cable Mains cable Door seal Tray handle Tray Carrier, rotatable, for 6 trays or 3 standard tray cassettes 10 Drain hose for waste water and fresh water 11 Water drain hose for "automatic water discharge"... -
Page 9: Scope Of Delivery
Sterile air filter � � � � � � � � � � � � � � � � 6046-000-14 Hygoclave 90 ....6046-01 Door seal �... -
Page 10: Technical Data
Product description Technical data Electrical data for the unit Nominal voltage V AC Electrical frequency Rated power 2600 Standby consumption Fuses 2 x T 12 AH / 250 V~ (IEC 60127) Over-voltage category General technical data of device Dimensions (H x W x D) 48 x 57�5 x 54 Weight, empty Other technical data... - Page 11 Product description Electromagnetic compatibility (EMC) High-frequency emissions in accordance Group 1 with CISPR 11 Class B Mains impedance, in accordance with IEC 61000-3-11 Ω < 0�1 Harmonics in acc� with IEC 61000-3-2 Not applicable Voltage fluctuations/flickers in acc� with IEC 61000-3-3 Not applicable Conducted high-frequency disturbance variable V in acc�...
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Page 12: Type Plate
Product description 4.1 Type plate The type plate is located on the rear of the unit� 4.2 Conformity assessment This device has been subjected to conformity acceptance testing in accordance with the cur- rent relevant European Union guidelines� This equipment conforms to all relevant require- ments�... -
Page 13: Operation
18 Door spindle 19 Adjustable feet, for height adjustment of the unit The Hygoclave 90 small steam steriliser is used to sterilise objects with steam at temperatures of 121 °C or 134 °C under pressure� The unit sterilises on the basis of the fractionat- ed vacuum method�... - Page 14 Product description Drying phase Water container The parts for sterilisation in the sterilisation chamber are dried under vacuum� Afterwards the sterilisation chamber is vented via the sterile air filter and the door can be opened� Vacuum drying ensures optimum drying results even when the parts for sterilisation are pack- aged�...
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Page 15: Safety Devices
Product description Altitude – printed out via a network printer – forwarded to document creation software Adjustments for altitude (above mean sea level) and therefore to the ambient pres- 5.2 Safety devices sure are performed automatically� The unit has several safety devices for protect- Operating elements ing the operator, patient and unit: –... - Page 16 Product description Safety valve A safety valve ensures pressure is released if the pressure is higher than 2�6 bar� Additional function check With the aid of test programs, it is possible to perform additional function checks at any time: – Check the device for leakages in the steam system with the vacuum test –...
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Page 17: Overview Of Programs
Product description 5.3 Overview of programs Type tests Universal Quick pro- Gentle Prions program gram program program Programme type in accordance with EN Type B Type B Type B Type B 13060 Dynamic pressure testing of the sterilisation chamber Air leakage Empty chamber test Bulky load Porous partial load... -
Page 18: Tyscor Pulse (Optional)
Product description 5.4 Tyscor Pulse (optional) The software is connected via the network to the units from Dürr Dental and displays the current sta- tus as well as messages and errors� All messages are logged and can be printed or sent� Regular maintenance and upkeep is implemented in the tasks�... -
Page 19: Installation
Installation Requirements Installation 6.1 Installation/setup room 7.1 Carrying the unit The room chosen for set up must fulfil the fol- The unit must only be carried by two persons� lowing requirements: Use suitable carrying aids if necessary� – Solid, horizontal ground/floor –... -
Page 20: Removing The Protective Film From
Installation 7.4 Removing the protective film NOTICE from the touch screen A build-up of heat can impair correct operation of the unit. Grasp one corner of the protective touch This may result in a shortened service screen film and peel it off carefully� life and extended cycle times�... -
Page 21: Checking The Sterile Air Filter
Installation 7.6 Checking the sterile air filter Installation example with a water treatment system Open the cover� Check to make sure that the sterile air filter is pushed in as far as it will go� Close the cover� 7.7 Connecting the unit Installation examples Installation example e.g. -
Page 22: Work
Installation Detachable mains cables must only be re- Connection of a water treatment system placed with suitable, equivalent mains cables (optional) with the same performance data – refer to the Connect a pressure hose to the "automatic inscription on the mains plug and mains ca- fresh water supply"... - Page 23 Installation Network protocols and ports A copy of the system manufacturer‘s declaration in accordance with Article 12 Port Purpose Ser- of Directive 93/42/EEC can be found in vice our download section at www�duerrden- 9100 TCP Record printer and la- tal�com (document no� 9000-461-264)� bel printer 137 UDP, Network drive...
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Page 24: Configuring The Unit
Installation Configuring the unit 8.3 Language selection Requirements: The following settings will need to be checked – Operator, Administrator or Service Technician and possibly adjusted by an administrator or access level selected� Service Technician� Touch Settings > System Settings > Lan- These settings are made via the touch screen of guage�... -
Page 25: Parameter Selection
Installation 8.7 Configuring a log printer Select the time zone and touch OK to con- firm� In order to be able to print out sterilisation re- Touch Time Server� cords on the log printer, the network connection Touch NTP Server� needs to be configured and the parameter Log Enter the address of the NTP server and printer needs to be enabled�... -
Page 26: 8�10 User Management
Installation 8.9 Configuring the network drive Enter the operator name and touch confirm� The network drive needs to be enabled The operator will then appear in the list� under Settings > System Settings > Parameters so that the data can be Changing an operator:: output to the network drive�... -
Page 27: 8�12 Touch Screen
Installation Monitoring the device with The changed calendar entry is then dis- played in the list and in the graphical rep- Tyscor Pulse resentation� Further information on Tyscor Pulse can Deleting a calendar entry: be found in the software help and in the Touch the calendar entry in the list�... -
Page 28: Add Device
Installation 9.3 Add device Adding the device in the cockpit All devices that are connected to the software can be added to the cockpit� When the unit is Requirements: first connected to the software, the unit is auto- matically added to the cockpit� –... -
Page 29: Test Programs
Recording the vacuum test Switch on the unit� Touch Settings > Maintenance > Diagnostic The Hygoclave 90 can also generate re- Functions > Bowie-Dick TestStart� cords for the vacuum tests performed� These are not saved automatically; they can be saved manually�... -
Page 30: Logging Handover And Installation
Installation 11 Logging handover and 12 Validation for installation commissioning The device has been subjected to a type test in It is necessary for a handover and instal- accordance with DIN EN 13060� Test loads are lation record to be completed as proof of used for this purpose�... - Page 31 6046100064L02 1702V002SE...
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Page 32: Operation
Operation 13 Operation Via the Help button you can access fur- ther information and instructions relevant 13.1 Switching the unit on/off to the screen� To switch the unit on or off: press the on/off Messages key for at least 2 seconds� The Messages view shows all currently active messages�... - Page 33 Operation Overview of programs The program selection depends on the load and its temperature resistance, as well as on the type of packaging� Program Process parame- Drying Load Test Type ters / Operating time 134°C, 5�5 min / 16 min For 6 kg of instruments Helix test or 2 kg of textiles, in...
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Page 34: 13�3 Time Preset
Operation Operating the touch screen Result: The selected program will start with the time NOTICE preset� Damage to the touch screen due to After the start of the time preset it is no incorrect handling longer possible to select any other menu� Only operate the touch screen using The time preset is only active for the one- your fingertips or the stylus�... -
Page 35: 13�5 Opening And Closing The Door
Operation A selection list is generated listing all records in Note the memory� Important information about the device The selection list can be filtered and sorted (LOT, date, time, etc�)� Information 13.5 Opening and closing the door Establishing a connection to the device Opening and closing the door is only possible when the unit is switched on�... -
Page 36: 13�6 Preparations For Steam
Operation Touch Close door� The sterilisation chamber is automatically Firmly press the door shut with your flat hand preheated to 121 °C in the default settings� for at least 3 seconds� At average room temperatures the preheating The door is automatically pulled in and will take approx�... - Page 37 Operation It is possible to use e�g� reusable container sys- WARNING tems or soft packaging, such as transparent Sterilisation success at risk sterile product packaging, paper bags, sterilisa- Depending on the textile load, hygro- tion paper, textiles or non-woven material� scopic condensation can occur, particu- In addition, it is also possible to use e�g�...
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Page 38: 13�7 Loading The Items For Sterilisation
Operation The use of unsuitable care products, e�g� sterilisation chamber provided the maximum water-repellant care products or oils that individual or overall weight is not exceeded� are impermeable to steam, may result in the Soft sterile product packaging should be ar- instruments not being sterile after sterilisation�... -
Page 39: 13�8 Steam Sterilising
Operation 13.8 Steam sterilising Fractionation Starting the program Close the door (see "13�5 Opening and closing the door")� Touch the chosen program, e�g� Quick program� Touch Start� The unit will automatically check the amount and conductance value of the fresh water� The cycle sequence is displayed schematically, as are the current values for status description/ pressure/time�... - Page 40 Operation Vacuum drying ensures optimum drying results CAUTION even when the parts for sterilisation are pack- The parts for sterilisation, chamber aged� and inner door are very hot. Touching hot objects can cause skin Program end burns� Do not touch hot objects� Use the tray grip for removing the trays�...
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Page 41: 13�9 Storing Parts For Sterilisation
Operation Removing parts for sterilisation Approval process According to the Robert Koch Institute (RKI) CAUTION ("Hygiene requirements during the reprocessing The parts for sterilisation, chamber of medical devices"), the reprocessing of instru- and inner door are very hot. ments ends with the documented approval for Touching hot objects can cause skin storage and use of the parts for sterilisation�... -
Page 42: En 14 Documenting The Sterilisation
Operation 14 Documenting the 13.9 Storing parts for sterilisation Only use standards-compliant packaging for sterilisation the products to be sterilised� 14.1 Batch documentation Comply with the stated storage conditions: – Store the parts protected against contam- The batch documentation is required as proof of ination successful completion of the sterilisation pro- cess and as a mandatory quality assurance... -
Page 43: 14�2 Automatic Record Output
Operation 14.2 Automatic record output When using the SD memory card as the storage medium, make sure that it is correctly inserted It is possible to automatically output the corre- and insert it if not� sponding record to an output medium (SD memory card, printer) immediately after the end We recommend taking out the SD mem- of a program�... - Page 44 Operation Example of a sterilisation record 6 7# # . 6 7# # *, -#4 $& !" ## # 6 # # ...
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Page 45: Messages On The Touch Screen
Operation 15 Messages on the touch screen For information about the display of Caution and Fault messages refer to "Trouble- shooting"� 15.1 Note Information for the operator� The unit continues to operate� Message: Note Program cycle starts after preheating phase� Cycle type B running�... - Page 46 Operation 15.2 Information Important information for the operator, e�g� about the current status of the device� The unit continues to operate� Message: Information Select the days for which a new preheating time is to be set� Test criteria: integrity, dryness, leak tightness Drying process manually cancelled Drying process cancelled 6046100064L02 1702V002SE...
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Page 47: Operating Pauses
Operation 16 Operating pauses 17 Taking out of operation If the unit is to be taken out of operation for an 16.1 Pause times extended period, e�g� due to a holiday, proceed Short pauses between sterilisation runs as follows: Keep the door closed when the unit is Remove the plug from the power outlet�... -
Page 48: Restarting After An Extended Pause In
Operation 18 Restarting after an ex- tended pause in operation Manually fill the fresh water container� Open the water supply if using a water treat- ment system� Perform a vacuum test� Perform a Bowie-Dick test� Perform an empty sterilisation with the quick program�... -
Page 49: Maintenance
Operation 19 Maintenance To ensure proper operation and maintain the service life of the appliance, it is necessary to carry out cleaning and maintenance work diligently� Inadequately or not carried out maintenance work can cause premature defects that are not covered by the warranty�... -
Page 50: 19�2 Complete Cleaning
Operation 19.2 Complete cleaning Avoid the formation of stains. Proper instrument preparation can prevent resi- For problem-free operation of the unit, correct due from being loosened from the load under cleaning and maintenance are necessary� steam pressure during sterilisation� Only carry out cleaning measures when the Loosened remains of dirt can clog the filters, appliance is cold�... - Page 51 Operation Allow all of the waste water to drain out into Manually filling the fresh water container the container, then empty the container� The capacity of the fresh water container is 4 li- Press the release mechanism on the quick re- tres�...
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Page 52: 19�3 Cleaning Or Replacing The Door
Operation 19.3 Cleaning or replacing the door Insert a new door seal by hand� Observe the correct sequence when inserting seal the door seal� The door seal must lie evenly in Regularly clean the door seal and check it for the sealing groove�... -
Page 53: 19�5 Clean Or Replacing Water Filters
Operation Apply a small amount of oil in the threaded bush (in the door of the unit)� 19.5 Clean or replacing water filters Remove the covers of the waste water and fresh water containers� Change the water filter in the fresh water con- tainer when soiled or if required�... -
Page 54: 19�7 Function Check
Operation 19.7 Function check Automatic function check Thanks to the electronic parameter control, the interactions between the sterilisation-relevant parameters pressure, temperature and time is constantly and automatically monitored� The process evaluation system of the unit com- pares the process parameters with each other while the program is running and monitors them in relation to their limit values�... -
Page 55: Troubleshooting
Troubleshooting 20 Tips for operators and service technicians Any repairs above and beyond routine maintenance must only be carried out by suitably qualified personnel or by one of our service technicians� Prior to working on the device or in case of danger, disconnect it from the mains (e� g� pull the mains plug)�... - Page 56 Troubleshooting Message: Fault Remedy Sterilisation process failed Repeat the sterilisation process, if necessary re-pack the parts for sterilisation� Restart the program� Manual cancellation� Load not sterile� Possibly Possibly re-pack and sterilise� re-pack� Program has been cancelled� Load not sterile� Possibly re-pack and sterilise� Possibly re-pack�...
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Page 57: Emergency Opening Of The Door
Troubleshooting 21 Emergency opening of the Check the pressure equalisation using a pres- sure gauge� door CAUTION If the steam steriliser loses power during opera- Risk of injury due to pressure in the tion as a result of an incident, e�g� due to a sterilisation chamber power outage, it is possible to manually open Do not open the door until the... -
Page 58: Appendix
Appendix 22 Settings menu layout Level 1 Level 2 Level 3 Level 4 Access level Operator Administrator Service Technician (password) Device Information Unit data Dealer Info System Settings Language German (DE) English (EN) Time/Date Date Time Time zone Time server Network Device Name... - Page 59 Appendix Level 1 Level 2 Level 3 Level 4 Calendar User management Select the user Maintenance Device maintenance Door seal Sterile air filter Validation Diagnostic functions Water Steam generator Locking/opening the door Generating pressure Generating a vacuum Emptying the steam generator Performing a vacuum test Visible from access level Operator or higher Visible from access level Administrator or higher...
- Page 64 Hersteller/Manufacturer: DÜRR DENTAL SE Höpfigheimer Str. 17 74321 Bietigheim-Bissingen Germany Fon: +49 7142 705-0 www.duerrdental.com info@duerrdental.com...
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