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Durr Dental 6046-01, Nstallation And Operating Instructions, Page: 1 / 68

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EN

Hygoclave 90

Installation and operating instructions

0297

6046100064L02

*6046100064L02*

2007V003

Summary of Contents for 6046-01

Page 1: ...EN Hygoclave 90 Installation and operating instructions 0297 6046100064L02 6046100064L02 2007V003 ...

Page 2: ......

Page 3: ...ety devices 15 5 3 Overview of programs 17 Assembly 6 Requirements 18 6 1 Installation setup room 18 7 Installation 18 7 1 Carrying the unit 18 7 2 Remove the transport locks 18 7 3 Setting up the unit 18 7 4 Removing the protective film from the touch screen 19 7 5 Checking the SD memory card 19 7 6 Checking the air filter 20 7 7 Connecting the unit 20 7 8 Connecting the device to the network 22 ...

Page 4: ...46 14 1 Note 46 14 2 Information 47 15 Operating pauses 48 15 1 Pause times 48 16 Taking out of operation 48 16 1 Transport 48 17 Restarting after an extended pause in operation 49 18 Maintenance 50 18 1 Maintenance schedule 50 18 2 Complete cleaning 52 18 3 Cleaning or replacing the door seal 54 18 4 Checking the hinge and lubricat ing the door spindle 55 18 5 Clean or replacing water filters 55 ...

Page 5: ...gerous high voltage Warning hot surfaces The warnings are structured as follows SIGNAL WORD Description of the type and source of danger Here you will find the possible conse quences of ignoring the warning Follow these measures to avoid the danger The signal word differentiates between four levels of danger DANGER Immediate danger of severe injury or death WARNING Possible danger of severe injury...

Page 6: ...sonal injury due to lack of hygiene e g infection 2 1 Intended purpose The Hygoclave is a small steam steriliser in accordance with DIN EN 13060 and is designed for medical use 2 2 Indications None 2 3 Contraindications None 2 4 Intended use The programs offered by the steam steriliser ena ble the selection of type B sterilisation cycles This means that it can be used to sterilise bulky products p...

Page 7: ...arm to the surroundings If it is not 100 clear from the unit data sheet that such connections can be safely made or if you are in any doubt always get a suitably qualified person e g the manufacturer to ver ify that the setup is safe Where applicable the requirements for medical products have been taken into account in the development and construction of the device As a result this device is suita...

Page 8: ...inal packaging Keep the packing materials out of the reach of children 2 15 Disposal Unit The unit may be contaminated Instruct the company disposing of the waste to take the relevant safety precautions Decontaminate potentially contaminated parts before disposing of them Uncontaminated parts e g electronics plastic and metal parts etc should be disposed of in accordance with the local waste dispo...

Page 9: ...icable check with the antivirus soft ware and remove the virus Perform regular data backups Restrict access to units to trustworthy users e g via a user name and password Make sure that only trustworthy content is downloaded Only install software and firmware updates that have been authenticated by the manufacturer Important information 6046100064L02 2007V003 7 EN ...

Page 10: ...memory card 4 Network cable 5 Mains cable 6 Door seal 7 Tray handle 8 Tray 9 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 12 Stylus with magnetic holder Product description 8 6046100064L02 2007V003 EN ...

Page 11: ... label printer network capable 6046100035 Labelling set for Hygoprint Plus 6046100130 Hygopure 90 reverse osmosis system 6046100017 Hygodem 90 ion exchanger 6046100114 Hygotest Helix test bodies with test strips 6050 600 03 3 4 Consumables The following materials are consumed during operation of the device and must be ordered separately FD 333 rapid surface disinfection CDF333C6150 FD 350 Classic ...

Page 12: ...onse pressure relative safety valve bar 2 55 Water and dust protection IEC 60529 IP 20 in accordance with EN ISO 3746 Technical data for the sterilisation chamber Internal dimensions useable volume Æ x D cm 26 x 35 Volume l 19 Load capacity unpackaged instruments Bulky hollow instruments Porous materials kg kg 6 2 Sterilisation temperature in accordance with EN 13060 C 134 3 Heat up time at room t...

Page 13: ...te Mbit s 100 Connector RJ45 Type of connection Auto MDI X Cable type CAT5 Classification Medical Device Class IIa Electromagnetic compatibility EMC High frequency emissions in accordance with CISPR 11 Group 1 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 Cond...

Page 14: ...ice 4 2 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 Product description 12 6046100064L02 2007V003 EN ...

Page 15: ... with steam at temperatures of 121 C or 134 C under pressure The unit sterilises on the basis of the fractionated vacuum method This ensures that the objects being sterilised are wetted or penetrated with saturated steam This method is suitable for steam sterilisation of all loads that will be encoun tered in a medical practice The sterilisation chamber is protected against overheating Use fresh d...

Page 16: ...t is equipped with a fresh water container left hand side and a waste water container right hand side The maximum capacity of each container is 4 litres Depending on the selected program and the load an average of approx 7 sterilisation cycles is possible The minimum and maximum fill levels are detec ted via a water level sensor Fresh water supply The supply with fresh water is provided either via...

Page 17: ...limit values the unit outputs warnings or fault messages and cancels the program if necessary If the program is cancelled a message will be dis played on the touch screen Safety door latch The device continuously monitors the pressure and temperature and will not allow the door to be opened if overpressure is present in the sterilisa tion chamber The automatic door latch ensures that the door only...

Page 18: ...he 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 Use the Bowie Dick test to check that the steam penetration of porous items for sterilisa tion e g textiles is sufficient Product description 16 6046100064L02 2007V003 EN ...

Page 19: ...porous load X X X Sterilising temperature 134 C 134 C 121 C 134 C Steriliser pressure absolute 312 0 kPa 312 0 kPa 210 7 kPa 312 0 kPa Hold time 5 5 min 5 5 min 20 5 min 20 min Max bulky load 10 kg 6 kg 6 kg 10 kg Max single weight e g load on tray stand ard tray cassettes 3 3 kg 2 kg 2 kg 3 3 kg Max massive load in containers 10 kg 6 kg 10 kg Max single packed bulky load 6 kg 1 5 kg 6 kg 6 kg Max...

Page 20: ... plug connections must be freely accessible so they can be quickly disconnec ted if there is any danger 7 Installation 7 1 Carrying the unit The unit must only be carried by two persons Use suitable carrying aids if necessary 2x 7 2 Remove the transport locks Remove the internal and external packaging materials and transport protection 7 3 Setting up the unit The unit is intended for operation out...

Page 21: ... Align the unit in both planes so that it is hori zontal using the two front adjustable feet On the underside of the unit there are 2 adjust able feet at the front and 2 roller feet at the rear which are used for easier positioning of the unit When adjusting the unit make sure that it is secured at all times so that it cannot fall down e g by getting somebody else to help The design of the interna...

Page 22: ...l waste water container or if a hose for auto matic water discharge is connected it flows away directly A message is displayed when the waste water container is full The waste water then needs to be manually drained Installation example with a water treatment sys tem 1 2 3 4 5 6 7 8 9 10 11 12 13 Installation example e g Hygopure 90 sche matic diagramme 1 Cover for waste water container and fresh ...

Page 23: ...t system if one is connected Manually filling the fresh water container WARNING Use of tap water compromises sterili sation The use of tap water can lead to the fol lowing problems Sterilisation cycles may be unsuccessful due to the intro duction of incondensable gases Forma tion of spots on sterilised objects The unit may be damaged Only use high quality distilled or dem ineralised water Guidelin...

Page 24: ...inter To connect the label printer Hygoprint Plus Dürr Dental refer to the instructions included with the Hygoprint Plus The following description is provided in addition to this and covers connection of the label printer to the Hygoclave 90 Connecting a label printer via a router Before connecting the devices check the safety of the electrical connections see 7 7 Connect ing the unit Connect the ...

Page 25: ...r the password 1234 Select the network configuration TCP IP Set the IP protocol to Permanent and enter the required IP address e g 192 168 254 250 subnet mask 255 255 255 0 and port 9100 Select Send changes Save the current configuration Close the web browser Print out the configuration status and check the IP address see above Connect the Hygoprint Plus using a crossover cable to the Hygoclave 90...

Page 26: ...rm The text appears in row 1 Add further rows as required Confirm with OK 8 3 Language selection Requirements ü Operator Administrator or Service Technician access level selected Touch Settings System Settings Lan guage Select the language Confirm with OK 8 4 Configuring the device with a network connection If the unit is connected to the network then you can send the sterilisation records to a lo...

Page 27: ...der to be able to print out sterilisation records on the log printer the network connec tion needs to be configured and the parameter Log printer needs to be enabled The log printer must be postscript capa ble Requirements ü Administrator or Service Technician access level selected Configuring the network connection Touch Settings System Settings Net work Touch Log printer Enter the IP address or ...

Page 28: ...Interactions with other medical devices cannot be completely ruled out Apply the IEC 80001 1 standard for risk assessment The device is not suitable for direct connection to the public internet When connecting the unit to other devices such as a computer system make sure that e g the computer monitor or printer that is are connected is are compliant with at least the standard IEC 60950 1 or IEC 62...

Page 29: ...ou can view and edit the calendar under Set tings Calendar Requirements ü Administrator or Service Technician access level selected Touch Settings Calendar The calendar is shown in a graphical represen tation Touch Edit The calendar entries are shown as a list Creating a calendar entry Touch New Touch the weekdays that are to be activated You can choose one or more weekdays Enter the times between...

Page 30: ...e sched ule 18 1 Maintenance schedule 9 Test programs 9 1 Vacuum test The vacuum test is used to test the device for leaks in the sterilization chamber A vacuum test should be performed in the follow ing situations Once a week during routine operation During commissioning After operating pauses longer than 2 weeks After replacing the door seal Perform the vacuum test with the unit cold and dry The...

Page 31: ...ing alternative indicator system In order to test performance it is possible to rou tinely perform proof of steam penetration Carry out the test in accordance with the manu facturer s information Switch on the unit Tap Actions Start Bowie Dick Test 10 Validation for commission ing The device has been subjected to a type test in accordance with DIN EN 13060 Test loads are used for this purpose In o...

Page 32: ...11 Handover record Carry out and document the instruction and handover for the unit A sample handover report is included in the attachment Assembly 30 6046100064L02 2007V003 EN ...

Page 33: ...ation and instructions relevant to the screen Messages The Messages view shows all currently active messages Here the messages are divided into the following categories Fault Unit will no longer function When the error has been remedied it may be neces sary to acknowledge the error message Notice After acknowledgement the unit will continue to work but only with limited functions Note Important in...

Page 34: ...Prions program Usage 32 6046100064L02 2007V003 EN ...

Page 35: ...ments or 2 kg of textiles in single and multiple packaging especially in cases of suspected infection with prions For 10 kg with con tainer loading Helix test B Without drying minimum maximum operating time without 10 kg container load dependent on load and installation conditions e g mains voltage room climate Sufficient drying may not be ensured in all cases during the sterilisation of plastics ...

Page 36: ...tings System Settings Param eters Time Preset Enter the required time after starting a pro gramme Touch Start Result The selected program will start with the time pre set After the start of the time preset it is no longer possible to select any other menu The time preset is only active for the one off time and program selection i e the time preset expires after the end of the program While the tim...

Page 37: ... on the start screen will appear after approx 1 minute The software of the unit is initialised and the device components are checked The sterilisation chamber is automatically prehea ted to 121 C in the default settings At average room temperatures the preheating will take approx 22 minutes It is possible to select a program during the pre heating phase The program starts automatically as soon as ...

Page 38: ...allel to each other Stack the textiles as vertically as possible and not too tightly in the sterilisation containers so that flow channels can form If textile packages will not hold themselves up wrap them in sterilisation paper Only sterilise dry textiles The textiles must not be in any contact with the walls of the sterilisation chamber as they will otherwise suck up condensation until they are ...

Page 39: ...ion cham ber This ensures optimum steam penetration and drying When using several standard tray cassettes make sure that steam penetration is not obstructed by covering of the perforations Where possible only stack sterilisation contain ers of the same size above each other on which the condensation can run off to the side When using stackable container systems these can be placed without a carrie...

Page 40: ...se Conditioning In the overpressure range steam is let off and regenerated as a result of which the load is con ditioned Fractionation A vacuum is generated in several phases depending on the programme The air is removed and replaced with steam This process is repeated until the preset venting capacity is reached Sterilisation Saturated steam is generated inside the steriliser chamber until the sp...

Page 41: ... Use the tray grip for removing the trays Allow the trays and parts for sterilisa tion to cool down Touch Open door If the program is aborted during the Drying phase then the parts for sterilisation are sterile This step is available so that the parts for sterili sation can quickly re available Unpackaged parts for sterilisation will dry during cooling as a result of their own heat Drying is impor...

Page 42: ...ust be performed by authorised and competent personnel Batch indication This includes checking on the basis of indicators carried at the same time e g individual indica tors or indicator systems test body and indica tor during the cycle The indicators can only be approved after a full colour changeover of the indicator strips Batch release The batch release comprises checking the process parameter...

Page 43: ...ion of the sterilisation process and as a mandatory quality assurance measure The data such as the program type batch and process parameters for all executed programs is saved in the internal protocol logger of the unit For the batch documentation the internal proto col logger can be read out and the data transfer red to various output media This can be done immediately after every cycle that has ...

Page 44: ...Settings Parameters The enabled output medium must be inserted SD memory card or connected computer printer If it is not possible to automatically output a record for example because the ena bled output medium is not connected then a warning will be displayed 13 3 Subsequent output of saved records Records can be output subsequently i e at a later time than when the program ends The out put media ...

Page 45: ...141 4 109 0 FRAC2 STEAM 10 04 40 17 0 98 2 FRAC3 EVAC 11 05 05 141 1 109 0 FRAC3 STEAM 12 05 38 17 0 71 6 FRAC4 EVAC 13 07 13 312 2 135 7 STER BEGIN 14 07 13 312 2 135 7 STER TMin 15 07 33 311 3 135 7 STER PMin 16 09 26 313 4 135 9 STER TMax 17 11 38 313 7 135 9 STER PMax 18 12 44 312 6 135 8 STER END 19 19 45 4 3 119 4 DRY1 EVAC 20 19 45 4 3 119 4 DRY1 VENT BEGIN 21 20 27 80 5 121 2 DRY1 PMax 22 ...

Page 46: ...ation 18 11 Chamber temperature 33 6 C 0 4 C 0 0 C Test pressure 11 5 kPa 0 4 kPa 0 4 kPa Test period 1 05 00 min Test period 2 10 00 min Pressure increase 1 0 0 kPa p2 p1 Pressure increase 2 0 0 kPa p3 p2 A ir le a k a g e r a te 0 00 kPa min C y cle log T im e P r e s s u r e Te m p ID m m s s k P a C 1 00 00 50 4 32 6 START 2 00 35 97 9 34 3 LEAKTEST P0 3 03 11 11 1 33 6 LEAKTEST P1 4 08 11 11 ...

Page 47: ...any labels to print Printing labels from the archive Under Actions Print labels you can always see the 50 most recent logs reports As soon as at least 50 logs have been saved the button Archive becomes active Older logs are displayed in the archive Actions Print labels Archive Tap the Archive button Select the log range e g 100 0 200 100 300 200 etc Select the log report Tap the Print button Usage...

Page 48: ...ed and is in the permissible range Vacuum test was cancelled Chamber temperature must be below 70 C Please hold the door shut for 3 sec The door closes automatically after contact is made The door has been closed The vacuum can be generated after locking The door has been locked Please wait The sterilization chamber is being ventilated and will then open automatically Rinsing process successfully ...

Page 49: ...ent 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 Usage 6046100064L02 2007V003 47 EN ...

Page 50: ...s take the unit out of operation see 16 Taking out of operation 16 Taking out of operation If the unit is to be taken out of operation for an extended period e g due to a holiday proceed as follows Remove the plug from the power outlet Drain clean and if necessary disinfect the inter nal fresh water and waste water containers Shut off the water supply if using a water treat ment system 16 1 Transp...

Page 51: ...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 Usage 6046100064L02 2007V003 49 EN ...

Page 52: ...ricating the door spindle Regularly Before carrying out maintenance or a validation please check whether a new firmware update is available This can be found under www duerrdental net services download center As required Clean and disinfect accessory parts e g tray tray handle If there is soiling Carry out complete cleaning see 18 2 Complete cleaning Clean or replace the water filter see 18 5 Clea...

Page 53: ...e 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 6046100064L02 2007V003 51 EN ...

Page 54: ...n the chamber or on the carrier use a mild chlorine free cleaning agent that is suitable for stainless steel and has no abrasive properties ph value 5 8 Use a neutral liquid cleaner for housing parts and the door seal Make sure that no cleaning agents get into the pipes that come out from the chamber Clean the cover Wipe clean and dry the covers of the waste water and fresh water containers on a r...

Page 55: ...upling adapter can be dis infected e g in instrument disinfectant ID 212 ID 212 forte or ID 213 from Dürr Dental Cleaning the water containers If the fresh water is supplied via the internal fresh water container then the following must be noted Before every refilling of the fresh water check the fresh water and waste water containers for dirt and contamination and clean and disinfect them if requ...

Page 56: ...sealing groove If the groove is dirty carefully clean it with a cleaning sponge and clear water Then re wipe the sealing groove with a soft cotton cloth Insert a new door seal by hand Observe the correct sequence when inserting the door seal The door seal must lie evenly in the sealing groove Smooth out any waviness or elevations by pressing in with your finger 3 4 1 2 8 7 6 5 Confirming replaceme...

Page 57: ...ly a small amount of oil in the threaded bush in the door of the unit 18 5 Clean or replacing water fil ters 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 Use the instal lation aid to insert the water filter 1 2 1 Water filter in the fresh water container 2 Water filter in the waste water container U...

Page 58: ...ust them if necessary see 8 6 Parame ter selection Calibrate the touch screen see Touch screen calibration 18 8 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 parame...

Page 59: ...y re pack Possibly re pack and sterilise Process cancelled Assess the messages on the touch screen Vacuum test failed Check the door seal replace if necessary The fresh water level is low Please fill up with fresh water Fill up with fresh water The fresh water container is not full Please fill up with fresh water Fill up with fresh water The waste water container is full Empty the waste water cont...

Page 60: ...water supply ensured Notify customer service if necessary Fresh water filling aborted Overpressure in the steam generator Notify customer service The water temperature is too high in the steam generator Notify customer service The water level in the steam generator is too low Check the fresh water supply notify customer service if necessary Preheating temperature not attained Notify customer servi...

Page 61: ...ntries has been reached The door could not be closed Check the door seal replace if necessary Unable to copy to SD card Check the SD card replace if necessary Unable to copy to network drive Check the network connection Unable to print Check the connection to the printer if neces sary establish the connection Troubleshooting 6046100064L02 2007V003 59 EN ...

Page 62: ...pending on the timing of the cancellation in the program sequence it is possible for hot steam to escape when the door is opened CAUTION The parts for sterilisation chamber and inner door are very hot Touching hot objects can cause skin burns Do not touch hot objects Use the tray grip for removing the trays Allow the trays and parts for sterilisa tion to cool down Unplug the mains plug Remove the ...

Page 63: ...evice Information1 Device data Dealer Info System Settings1 2 Language 1 German DE English EN Time Date2 Date Time Time zone Time server Network 2 Unit MAC Name Interface DHCP IP address Netmask Gateway Label printer Name addr Port Log printer Name addr Port Network drive Server User name Password Appendix 6046100064L02 2007V003 61 EN ...

Page 64: ...ng the steam generator3 Performing a vacuum test1 Service data2 Save log data Save last 50 reports Save last 500 reports 1 Visible from access level Operator or higher 2 Visible from access level Administrator or higher 3 Visible from access level Service Technician or higher The access level Service Technician offers additional functions that must only be adjusted by Dürr Dental or by individuals...

Page 65: ...Order number REF Serial number SN o Visual inspection of the packaging for any damage o Unpacking the medical device and checking for damage o Confirmation of the completeness of the delivery o Instruction in the proper handling and operation of the medical device based on the operating instructions Notes Name of person receiving instruction Signature Name and address of the qualified adviser for ...

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Page 68: ...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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