Important information The signal word differentiates between four levels Important information of danger: – DANGER Immediate danger of severe injury or death About this document – WARNING Possible danger of severe injury or death These installation and operating instructions rep- resent part of the unit.
Important information Safety Wear protective gloves. Dürr Dental has designed and constructed this unit so that when used properly and for the inten- ded purpose it does not pose any danger to Disconnect all power from the unit. people or property. Despite this, the following residual risks can remain: Copyright information...
Important information If it is not 100% clear from the unit data sheet ❯ WARNING that such connections can be safely made or if you are in any doubt, always get a suitably The sterilisation of liquids can cause a qualified person (e.g.
Important information 2.15 Disposal Installation and repairs Installation, readjustments, alterations, ❯ Unit upgrades and repairs must be carried out by Dürr Dental or by qualified personnel specifi- The unit may be contaminated. Instruct cally approved and authorized by Dürr Dental. the company disposing of the waste to take the relevant safety precautions.
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Important information system needs to be protected from threats from the Internet. Use antivirus software and update it regularly. ❯ Look for evidence of possible virus infection and, if applicable, check with the antivirus soft- ware and remove the virus. Perform regular data backups.
Product description Product description Overview Steam steriliser Hygoclave 90 Air filters SD memory card Network cable Mains cable Door seal Tray handle Tray Carrier, rotatable, for 6 trays or 3 standard tray cassettes Drain hose for waste water and fresh water Water drain hose for "automatic water discharge"...
Hygoclave 90 ....6046-01 The following working parts need to be changed – Carrier for trays or standard tray cassettes at regular intervals (refer to the "Maintenance"...
Product description Technical data Electrical data for the unit Rated voltage V AC Mains frequency Rated power 2600 Fuses 2 x T 12 AH / 250 V~ (IEC 60127) General technical data of device Dimensions (H x W x D) 58 x 54 x 47.5 Weight, empty Other technical data...
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Product description Ambient conditions during operation Relative humidity 30 - 75 Air pressure 750 to 1060 Altitude above mean sea level < 2000 Internal memory Memory capacity 4,500 cycles Connection for "automatic fresh water supply connection" Union nut " Screw-in connector "...
Product description Type plate The type plate is located on the rear of the device. Evaluation of conformity 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 requirements. 6046100064L02 2007V003...
Door spindle 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 fractionated vacuum method.
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Product description Vacuum drying ensures optimum drying results Water container even when the parts for sterilisation are pack- aged. Sterilisation chamber The capacity of the sterilisation chamber is 19 litres. It can be filled with a load according to demand. The maximum load depends on the load type and the selected program.
Product description – saved to an SD memory card Altitude – saved to a network storage location Adjustments for altitude (above mean sea – printed out via a network printer level) and therefore to the ambient pres- sure are performed automatically. –...
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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 –...
Product description Overview of programs Type tests Universal Quick pro- Gentle pro- Prions pro- program gram gram gram 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...
Assembly Installation Assembly Carrying the unit The unit must only be carried by two persons. Requirements ❯ Use suitable carrying aids if necessary. ❯ Installation/setup room The room chosen for installation must satisfy the following requirements: – Solid, horizontal ground/floor –...
Assembly Align the unit in both planes so that it is hori- ❯ NOTICE zontal using the two front adjustable feet. On the underside of the unit there are 2 adjust- A build-up of heat can impair correct able feet at the front and 2 roller feet at the operation of the unit.
Assembly Take out the SD memory card and reinsert it: Connection for "automatic fresh water ❯ press it in slightly, carefully pull it out and then supply connection" slide it back in until it clicks. Electrical connections The unit is supplied with fresh water directly via a hose from the internal fresh water container.
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Assembly Electrical connections Manually filling the fresh water container Safety when making electrical connections WARNING The device must only be connected to a cor- ❯ Use of tap water compromises sterili- rectly installed and earthed power outlet. sation Do not use movable multi-way power outlets. ❯...
The network connection is used to exchange addition to this and covers connection of information or control signals between the unit the label printer to the Hygoclave 90. and a software installed on a computer, in order to, e. g.: Connecting a label printer via a router –...
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Assembly Wait at least 2 minutes so that an IP address is Assign a static IP address to the Hygoclave 90. ❯ ❯ automatically assigned to the printer. To do this, select Settings>System Set- tings>Network>Device. Disable DHCP, assign a dedicated IP address to the unit (e.g.
Assembly Configuring the unit Language selection Requirements: The following settings will need to be checked ü Operator, Administrator or Service Technician and possibly adjusted by an administrator or access level selected. Service Technician. Touch Settings > System Settings > Lan- ❯...
Assembly Select the time zone and touch OK to con- tion needs to be configured and the parameter ❯ firm. Log printer needs to be enabled. Touch Time Server. ❯ The log printer must be postscript capa- Touch NTP Server. ble.
The following requirements must be met in order figuration. to monitor the unit on the computer: The Hygoclave 90 uses the network pro- – Unit connected to the network tocol SMBv1 to save the protocols on the – Current monitoring software installed on the network drive.
Assembly 8.11 User management Touch Settings > Calendar. ❯ The calendar is shown in a graphical represen- The name of every operator needs to be created tation. to ensure that the approval process can be relia- Touch Edit. ❯ bly traced after the end of a sterilisation program. The calendar entries are shown as a list.
Assembly Test programs NOTICE If the touch calibration is incorrectly Vacuum test set up it may become impossible to The vacuum test is used to test the device for operate the device leaks in the sterilization chamber. Accurately follow the instructions provi- ❯...
Assembly Bowie-Dick test 10 Validation for commission- The Bowie-Dick test is used to prove steam pen- etration into the test load. It is designed in such a The device has been subjected to a type test in way that, if proof is obtained that steam has accordance with DIN EN 13060.
Assembly 11 Handover record Carry out and document the instruction and ❯ handover for the unit. A sample handover report is included in the attachment. 6046100064L02 2007V003...
Usage Actions Usage Settings Via the Help button you can access fur- ther information and instructions relevant 12 Operation to the screen. 12.1 Switching the unit on/off Messages Switching on the unit: ❯ The Messages view shows all currently active Touch the on/off switch for at least 2 seconds.
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Usage Prions program 6046100064L02 2007V003...
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Usage Overview of programs The program selection depends on the load and its temperature resistance, as well as on the type of packaging. Program Process parameters / Drying Load Test Type Operating time 134°C, 5.5 min / 16 min For 6 kg of instruments Helix test 12 - 23 min * or 2 kg of textiles, in...
Usage Result: Operating the touch screen The selected program will start with the time pre- set. NOTICE After the start of the time preset it is no Damage to the touch screen due to longer possible to select any other menu. incorrect handling The time preset is only active for the one- Only operate the touch screen using...
Usage Once the unit is switched on the start NOTICE screen will appear after approx. 1 minute. Damage to the door locking mecha- nism due to incorrect handling The software of the unit is initialised and the device components are checked. The unit is equipped with a motor-driven automatic door locking mechanism with door spindle.
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Usage Only sterilise dry textiles. Getting the packaging materials ready ❯ Only use packaging materials and systems that The textiles must not be in any contact with the ❯ are suitable for steam sterilisation according to walls of the sterilisation chamber, as they will the manufacturer information, or which satisfy the otherwise suck up condensation until they are standards DIN EN ISO 11607-1, standards series...
Usage After the end of manual reprocessing, rinse the Trays or standard tray cassettes should only be ❯ ❯ instruments with suitable water (preferably placed in the carrier in the sterilisation cham- demineralised or distilled water). ber. This ensures optimum steam penetration and drying.
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Usage 12.7 Steam sterilising Fractionation Starting the program Close the door (see "12.4 Opening and clos- ❯ ing the door"). Touch the chosen program, e.g. Quick pro- ❯ gram. 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/ temperature/pressure/time.
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Usage Vacuum drying ensures optimum drying results CAUTION even when the parts for sterilisation are pack- aged. The parts for sterilisation, chamber and inner door are very hot. Program end Touching hot objects can cause skin burns. Do not touch hot objects. ❯...
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Usage Removing parts for sterilisation Batch indication This includes checking on the basis of indicators CAUTION carried at the same time, e.g. individual indica- tors or indicator systems (test body and indica- The parts for sterilisation, chamber tor) during the cycle. and inner door are very hot.
Usage 12.8 Storing parts for sterilisation 13 Documenting the sterilisa- Only use standards-compliant packaging for ❯ tion the products to be sterilised. Comply with the stated storage conditions: 13.1 Batch documentation ❯ – Store the parts protected against contami- The batch documentation is required as proof of nation successful completion of the sterilisation process –...
Usage 13.3 Subsequent output of saved NOTICE records Data loss due to removal of the SD Records can be output subsequently, i.e. at a memory card during read/write later time than when the program ends. The out- access put media can then be chosen by the operator. Never remove the SD memory card ❯...
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Usage Example of a sterilisation record S te rilis a tion log 1 5 Jul 2 0 2 0 H y goc la v e 9 0 2 0 6 5 9 D e v i c e d a t a C y c l e l o g T i m e P r e s s u r e Te m p...
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Usage Sample vacuum test report Va c uum te s t 1 5 Jul 2 0 2 0 H y goc la v e 9 0 1 6 1 9 D e v i c e d a t a C y c l e l o g T i m e P r e s s u r e Te m p...
Usage 13.5 Print labels Requirements: Settings > System Settings > Parameters > Label printer must be activated. Tap the Actions button. ❯ Tap Print labels. ❯ Select the log (report). ❯ Tap the Print button. ❯ At the end of a cycle, you will be asked how many labels to print.
Usage 14 Messages on the touch screen For information about the display of Caution and Fault messages refer to "Troubleshoot- ing". 14.1 Note Information for the operator. The unit continues to operate. Message: Note Program cycle starts after preheating phase. Cycle type B running.
Usage 14.2 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 2007V003...
Usage 16 Taking out of operation 15 Operating pauses If the unit is to be taken out of operation for an extended period, e.g. due to a holiday, proceed 15.1 Pause times as follows: Short pauses between sterilisation runs Remove the plug from the power outlet. ❯...
Usage 17 Restarting after an exten- ded 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 ❯...
Usage 18 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.
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Usage Service interval Maintenance work Every 2 years Have electrical safety testing performed, e.g. in accordance with DIN VDE 0701 0702, and ensure compliance with country-spe- cific regulations. Every 4 years Arrange for replacement of the safety valve. Notify customer service.
Usage Clean the cover 18.2 Complete cleaning Wipe clean and dry the covers of the waste ❯ water and fresh water containers on a regular Cleaning the touch screen basis. We recommend using the disinfectants listed ❯ under "3.4 Consumables" for cleaning of the touch screen.
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Usage After cleaning, make sure that the stopper is ❯ NOTICE inserted in the waste water container. The water in the waste water con- tainer is contaminated. Take corresponding precautionary ❯ measures when draining it. Carry out disposal in accordance with ❯...
Usage Fill the fresh water container with distilled or Insert a new door seal by hand. ❯ ❯ demineralised water to the MAX mark (approx. Observe the correct sequence when inserting 4 litres). the door seal. The door seal must lie evenly in Make sure that the water does not overflow.
Usage 18.4 Checking the hinge and lubri- Change the water filter in the fresh water con- ❯ tainer when soiled or if required. Use the instal- cating the door spindle lation aid to insert the water filter. Water filter in the fresh water container Water filter in the waste water container Hinge Threaded bush...
Usage 18.6 Replacing the air filter After an update, we recommend the fol- lowing: Replace the air filter. ❯ When inserting the air filter, make sure that it is Check the parameter settings and read- pushed in all the way to the stop. just them if necessary, see "8.6 Parame- ter selection".
Troubleshooting Troubleshooting 19 Tips for operators and service technicians Any repairs exceeding routine maintenance may only be carried out by qualified personnel or our service. Prior to working on the unit or in case of danger, disconnect it from the mains. Error Possible cause Remedy...
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Troubleshooting 19.2 "Fault" messages The unit will no longer function. When the error has been remedied, it may be necessary to acknowledge the error message. Message: Fault Remedy Sterilization process failed Repeat the sterilisation process, if necessary ❯ re-pack the parts for sterilisation. Restart the program.
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Troubleshooting Message: Fault Remedy Calendar entry is invalid. Set up the calendar (see "8.12 Setting up the ❯ calendar"). Calendar memory space is full. The maximum number of entries has been ❯ reached. The door could not be closed. Check the door seal, replace if necessary. ❯...
Troubleshooting Remove the covers from the motor shaft and ❯ 20 Emergency opening of the pressure gauge on the rear of the unit. door If the steam steriliser loses power during opera- tion as a result of an incident, e.g. due to a power outage, it is possible to manually open the door in order to access the items being sterilised.
Appendix Appendix 21 Menu structure 21.1 Settings Level 1 Level 2 Level 3 Level 4 Operator Access level Administrator Service Technician (PIN) Device data Device Information Dealer Info German (DE) System Settings Language English (EN) ... Date Time/Date Time Time zone Time server Unit Network...
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Appendix Level 1 Level 2 Level 3 Level 4 Water supply System settings Parameters (continued) Time preset Calendar Preheat SD card Network drive Log printer Label printer Brightness Touch screen Touch calibration Calendar Select user User management Door seal Maintenance Device maintenance Air filters Maintenance counter...
Appendix 22 Handover record This document confirms that a qualified handover of the medical device has taken place and that appropriate instructions have been provided for it. This must be carried out by a qualified adviser for the medical device, who will instruct you in the proper handling and operation of the medical device. Product name Order number (REF) Serial number (SN)
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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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