Durr Dental Hygoclave 90 Installation And Operating Instructions Manual Download Page 44 | Manualshive

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6046100064L02 1702V002SE

Operation

Example of a sterilisation record

a

1

b

1

1

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3

4

XX

XX

a

1

b

1

1

2

3

4

Mrs. Musterfrau

1

Fractionated pre-vacuum

2

Pressure and temperature build-up

1a

Conditioning

3

Plateau time (holding time)

1b

Fractionation

4

Vacuum drying

EN

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Summary of Contents for Hygoclave 90

Page 1: ...EN 1702V002SE 6046100064L02 Installation and Operating Instructions Hygoclave 90 0297 ...

Page 2: ......

Page 3: ...1 Vacuum test 27 10 2 Bowie Dick test 27 11 Logging handover and installation 28 12 Validation for commissioning 28 Operation 13 Operation 30 13 1 Switching the unit on off 30 13 2 Touch screen 30 13 3 Time preset 32 13 4 Monitoring the device with Tyscor Pulse 32 13 5 Opening and closing the door 33 EN Contents Important information 1 About this document 3 1 1 Warnings and symbols 3 1 2 Copyright...

Page 4: ...2 Information 43 16 Operating pauses 45 16 1 Pause times 45 17 Taking out of operation 45 17 1 Transport 45 18 Restarting after an extended pause in operation 46 19 Maintenance 47 19 1 Maintenance schedule 47 19 2 Complete cleaning 48 19 3 Cleaning or replacing the door seal 50 19 4 Checking the hinge and oiling the door spindle 50 19 5 Clean or replacing water filters 51 19 6 Changing the sterile...

Page 5: ...this document These installation and operating instructions form part of the unit If the instructions and information in these installation and operating instruc tions are not followed Dürr Dental will not be able to offer any warranty or as sume any liability for the safe operation and the safe functioning of the unit 1 1 Warnings and symbols Warnings The warnings in this document are intended to...

Page 6: ... rials EN 61326 1 Electrical equipment for measurement control and laboratory use EMC requirements 2 Safety Dürr Dental has designed and constructed this device so that when used properly and for the intended purpose there is no danger to people or property Nevertheless residual risks can re main You should therefore observe the follow ing notes 2 1 Intended purpose The Hygoclave is a small steam ...

Page 7: ... Qualified personnel Operation Persons who operate the units must ensure safe and correct handling based on their training and knowledge i i Instruct or have every user instructed in han dling the unit i i Regularly train all operators who are responsi ble for use and maintenance of the device As part of this the operators must also demon strate that they have understood everything covered Attenda...

Page 8: ...ile air filter 3 SD 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 magnet bracket Product description EN ...

Page 9: ...s or standard tray cassettes Trays Tray handle SD memory card Stylus with magnet bracket Drain hose for manual emptying of fresh and waste water on the fore side of the device Water drain hose for automatic water dis charge on the rear side of the device Water filter set Hexagon key for emergency unlocking Sterile air filter Hygotest starter kit Network cable Mains cable Software Tyscor Pulse Inst...

Page 10: ... pressure absolute min kPa approx 5 Response pressure relative safety valve bar 2 55 Water and dust protection in acc with IEC 60529 IP 20 Degree of soiling in accordance with EN 61010 1 2 In accordance with EN ISO 1680 Airborne Noise Emissions measured in a sound insulated room Technical data for the sterilisation chamber Internal dimensions useable volume x D cm 26 x 35 Volume l 19 Load capacity...

Page 11: ...ia ble E1 in accordance with IEC 61000 4 3 V m 4 Internal memory Memory capacity 10 000 cycles Network connection LAN technology Ethernet Default IEEE 802 3u Data rate Mbit s 100 Connector RJ45 Type of connection Auto MDI X Cable type CAT5 Ambient conditions during storage and transport Temperature C 10 to 60 Relative humidity 85 Ambient conditions during operation Temperature C 15 to 35 Relative ...

Page 12: ... 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 EN ...

Page 13: ...ygoclave 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 This ensures that the ob jects being sterilised are wetted or penetrated with saturated steam This method is suitable for steam sterilisation of all loads that will be en countered in a medical practice The s...

Page 14: ...e water with optimum fresh water quality for steam generation in the unit The water treatment system is connected to the fresh water connection of the unit and to the in house water supply Drying phase 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 ens...

Page 15: ...amination of the unit are prevented assuming careful instrument preparation Electronic parameter control The device operates with electronic parameter control Values for pressure temperature and time are automatically monitored in the pro grams This ensures that the total running time of a program is optimised depending on the load Process evaluation system The process evaluation system monitors a...

Page 16: ...r 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 Use the Bowie Dick test to check that the steam penetration of porous items for sterili sation e g textiles is sufficient EN ...

Page 17: ...kaging X X X Drying bulky load X X X X Drying 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 sing...

Page 18: ...ar the side bar and the contents area 1 2 3 1 Menu bar 2 Side bar 3 Contents area The contents area depends on the tab selected on the side bar The current messages are always displayed in the lower part of the contents area If there are several current messages then the mouse wheel or the or buttons can be used to scroll through the messages The views and rights depend on the selected access leve...

Page 19: ...top so that the installed fresh water container can be filled and to ensure good ventilation 10 cm 85 kg 6 Requirements 6 1 Installation setup room The room chosen for set up must fulfil the fol lowing requirements Solid horizontal ground floor Closed dry dust protected interior room Should not be a room made for another pur pose e g boiler room or wet cell Required distances between the unit and ...

Page 20: ...of a fault the safety valve on the rear of the unit is triggered by overpressure i e if the pressure is above the normal operating pressure and hot steam is given off i i Install the unit in such a way that op erators are not put in any danger i i Place the unit on a horizontal table The load bearing capacity of the table must be suitable for the weight of the unit including op erating media and l...

Page 21: ...le multi way power outlets i i Make sure that none of the electrical cables leading to the unit are under any mechanical tension i i Before start up check the mains voltage against the voltage indicated on the type plate see also 4 Technical data 7 6 Checking the sterile air filter i i Open the cover i i Check to make sure that the sterile air filter is pushed in as far as it will go i i Close the...

Page 22: ...erning the units i i Detachable mains cables must only be re placed with suitable equivalent mains cables with the same performance data refer to the inscription on the mains plug and mains ca ble Connecting the unit to the mains The unit has no main power switch For this reason it is important that the unit is be set up in such a way that the plug can be easily accessed and unplugged if re quired...

Page 23: ...rk However some of the functions are not available in this case i i Incorrect manual configuration can lead to significant network problems The expert knowledge of a network administrator is re quired for configuration i i The data connection utilizes part of the band width of the network Interactions with other medical devices cannot be completely exclud ed Apply the IEC 80001 1 standard for risk...

Page 24: ...m i i Touch Time i i Set the time and touch OK to confirm Obtaining the date and time from a time server NTP server i i Touch Time Zone 8 Configuring the unit The following settings will need to be checked and possibly adjusted by an administrator or Service Technician These settings are made via the touch screen of the unit For further information about use of the touch screen see 13 2 Touch scre...

Page 25: ... confirm the settings Enabling parameters i i Touch Settings System Settings Parameters i i Enable the parameter Label printer i i Touch OK to confirm the settings i i Select the time zone and touch OK to con firm i i Touch Time Server i i Touch NTP Server i i Enter the address of the NTP server and touch to confirm i i Enable NTP i i Touch OK to confirm the settings 8 6 Parameter selection Depend...

Page 26: ... Change the weekdays and times as required i i Touch Save 8 9 Configuring the network drive The network drive needs to be enabled under Settings System Settings Parameters so that the data can be output to the network drive A user and password need to be entered for ac cess to the network drive This user must have read and write access rights to the network drive e g approved folder on the server ...

Page 27: ...endar entry is then dis played in the list and in the graphical rep resentation Deleting a calendar entry i i Touch the calendar entry in the list i i Touch Delete 8 12 Touch screen You can adjust the brightness and touch cali bration touch accuracy of the touch screen The default value for brightness is 35 During touch calibration a wizard will launch that will help you to adjust the required tou...

Page 28: ...i i To change the position of the device block click on the block and with the mouse key pressed drag it to the required location 9 3 Add device Requirements Unit is switched on and connected to the network Administrator or service technician access level selected in the software i i Working in the menu bar click on Device Manager The list of units appears A symbol displays the connection status t...

Page 29: ...rer s information i i Switch on the unit i i Touch Settings Maintenance Diagnostic Functions Bowie Dick TestStart i i or i i Touch Settings Start Bowie Dick Test 10 Test programs 10 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 following situations Once a week during routine operation During commissioning Af...

Page 30: ... loading i i This validation inspection qualification IQ operational qualification OQ and perfor mance qualification PQ should be performed by correspondingly trained experts or by a test laboratory Follow the country specific regulations See also DIN EN 13060 and EN ISO 17665 1 11 Logging handover and installation It is necessary for a handover and instal lation record to be completed as proof of...

Page 31: ...6046100064L02 1702V002SE 29 EN ...

Page 32: ...he operator The unit continues to operate The messages Fault and Caution are shown in full screen The messages Information and Note are shown in the message area The current message can be displayed in full screen via the Messages button Program icons Universal program Quick program Gentle program Prions program 13 Operation 13 1 Switching the unit on off i i To switch the unit on or off press the...

Page 33: ...26 35 min 16 min For 6 kg of instruments or 2 kg of textiles in single and multiple packaging especially in cases of suspected infection with prions For 10 kg with container 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 dur...

Page 34: ...ree operation Fault Operation of the device interrupted Warning Operation of the device restricted Operating the touch screen NOTICE Damage to the touch screen due to incorrect handling i i Only operate the touch screen using your fingertips or the stylus i i Do not use a sharp instrument e g ballpoint pen to operate the touch screen i i Protect the touch screen against wa ter i i Operate the touc...

Page 35: ...ection to the device Connection to the device interrupted If a message occurs for an device the symbol next to the device in the side bar changes The message appears in the cockpit and in the de vice details If several messages occur the symbol of the highest message level in each case is displayed As soon as a message concerning a de vice occurs the symbol in the task bar or Mac OS menu bar also ...

Page 36: ...rays Avoid using non perforated trays because the drying results will be poor Getting the packaging materials ready Only use packaging materials and systems that are suitable for steam sterilisation according to the manufacturer information or which satisfy the standards DIN EN ISO 11607 1 standards series DIN EN 868 i i Touch Close door 1 2 i i Firmly press the door shut with your flat hand for a...

Page 37: ...uitable for steam sterilisation Check with the manufac turer of the care product It is possible to use e g reusable container sys tems or soft packaging such as transparent sterile product packaging paper bags sterilisa tion paper textiles or non woven material In addition it is also possible to use e g stand ard tray cassettes or cassettes for implants in conjunction with sterile product packagin...

Page 38: ...lant care products or oils that are impermeable to steam may result in the instruments not being sterile after sterilisation 13 7 Loading the items for sterilisation into the unit Correct loading of the unit has an impact on the efficacy of sterilisation good drying of the items for sterilisation and therefore also on the warran ty WARNING The sterilisation of liquids can cause a risk of explosion...

Page 39: ...sterilisation chamber is vented via the sterile air filter and the door can be opened 13 8 Steam sterilising Starting the program i i Close the door see 13 5 Opening and closing the door i i Touch the chosen program e g Quick program i i 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...

Page 40: ...h the program is cancelled The sys tem will analyse the current phase and transfer the steam steriliser into a safe status For example if overpressure is present then the unit is briefly evacuated to drain off any condensation that has arisen i i Follow the messages on the touch screen and contact a Service Technician to have the unit checked Vacuum drying ensures optimum drying results even when ...

Page 41: ...n cause skin burns i i Do not touch hot objects i i Use the tray grip for removing the trays i i Allow the trays and parts for sterilisa tion to cool down i i Remove the trays from the unit using the tray handle DANGER Sterilisation success at risk due to defective sterile product packaging If a sterile product packaging tears open during sterilisation sterile storage is no longer possible i i Ste...

Page 42: ...the records for the pro grams that have run via the following output media and to archive them accordingly SD memory card Computer via the network Label printer Record printer The required output media can be selected un der Settings System Settings Parameters SD memory card In the delivery state of the unit the integrated SD memory card is enabled as the output medi um for the sterilisation recor...

Page 43: ... contents of the protocol log ger Provided the SD memory card is inserted the record is automatically also saved to the SD memory card at the end of the program The record can be viewed saved and if neces sary printed out via a computer In order to print out the record the network printer needs to be postscript capable When using the SD memory card as the storage medium make sure that it is correc...

Page 44: ...ation Example of a sterilisation record a 1 b 1 1 2 3 4 XX XX a 1 b 1 1 2 3 4 Mrs Musterfrau 1 Fractionated pre vacuum 2 Pressure and temperature build up 1a Conditioning 3 Plateau time holding time 1b Fractionation 4 Vacuum drying EN ...

Page 45: ...vacuum The vacuum has been tested and is in the permissible range Vacuum test was cancelled Chamber temperature must be below 40 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 automaticall...

Page 46: ...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 EN ...

Page 47: ...pply and remove the hose connec tions on the rear of the unit i i Close the door i i Switch off the unit and allow it to cool i i Transport the unit 16 Operating pauses 16 1 Pause times Short pauses between sterilisation runs i i Keep the door closed when the unit is switched on The unit thus requires less energy and can be maintained at temperature Pauses that last more than an hour i i Switch of...

Page 48: ...er an ex tended pause in operation i i Manually fill the fresh water container i i Open the water supply if using a water treat ment system i i Perform a vacuum test i i Perform a Bowie Dick test i i Perform an empty sterilisation with the quick program EN ...

Page 49: ...nd oiling the door spindle As required Clean and disinfect accessory parts e g tray tray handle If there is soiling Carry out complete cleaning see 19 2 Complete cleaning Clean or replace the water filter see 19 5 Clean or replacing water filters Clean the tray handle and trays Clean and dry the sterilisation chamber Clean the door seal After 1000 cycles or 1 year Replace the door seal see 19 3 Cl...

Page 50: ... into the con tainer provided i i Push the drain hose onto a quick release cou pling until it noticeably engages to drain the corresponding water container i i Allow all of the fresh water to drain out into the container then empty the container 19 2 Complete cleaning For problem free operation of the unit correct cleaning and maintenance are necessary Only carry out cleaning measures when the app...

Page 51: ...e water to drain out into the container then empty the container i i Press the release mechanism on the quick re lease coupling and remove the drain hose again i i For this reason the drain hose comes into contact with contaminated water as does the container used for emptying These objects must be cleaned and disinfected accordingly after use The drain hose consists of a silicone hose and a quick...

Page 52: ... Oil the door spindle every 2 months 19 3 Cleaning or replacing the door seal i i Regularly clean the door seal and check it for damage and correct positioning If necessary press the door seal carefully and evenly back into the sealing groove Replace the door seal if it is worn Replacing the door seal It is best to replace the door seal when the unit is cold Do not use any sharp objects that could...

Page 53: ... a small amount of oil in the threaded bush in the door of the unit 19 5 Clean or replacing water filters i i Remove the covers of the waste water and fresh water containers i i Change the water filter in the fresh water con tainer when soiled or if required Use the in stallation aid to insert the water filter 1 2 1 Water filter in the fresh water container 2 Water filter in the waste water contai...

Page 54: ...tests the device components to make sure they are working cor rectly and that their interactions are plausible If the parameters exceed defined limits warnings and fault reports are displayed If necessary the program is cancelled and a corresponding note is displayed If the program is successfully completed a cor responding message is displayed Test programs see 10 1 Vacuum test and 10 2 Bowie Dic...

Page 55: ...ure change exceeds 10 bar min Process cancelled i i Assess the messages on the touch screen Vacuum test failed i i Check the door seal replace if necessary The fresh water level is low Please fill up with fresh water i i Fill up with fresh water The fresh water container is not full Please fill up with fresh water i i Fill up with fresh water The waste water container is full i i Empty the waste w...

Page 56: ...rator is too low i i Check the fresh water supply notify customer service if necessary Preheating temperature not attained i i Notify customer service Overpressure in the steam generator i i Notify customer service The water quality is too low conductivity value exceeds 40 µS Please replace the fresh water and check the water supply i i Empty the fresh water clean the container and fill up with ne...

Page 57: ... used when the unit is working normally If the steam steriliser is de energised during op eration then depending on the phase in the program either the sterilisation chamber will be automatically vented under vacuum or the steam will be condensed in the condenser un der overpressure Since the condenser is no longer actively cooled when the unit is de ener gised a small amount of steam or condensat...

Page 58: ... 2 Language1 German DE English EN Time Date2 Date Time Time zone Time server Network2 Device2 Mac Name Interface DHCP IP address Netmask Gateway Label printer2 Name addr Port Record printer2 Name addr Port Network drive2 Server User name Password Parameters2 Water supply Time preset Calendar Preheat SD card Network drive Record printer Label printer Touch screen2 Brightness2 Touch calibration2 App...

Page 59: ...2 Generating a vacuum3 Emptying the steam generator3 Performing a vacuum test1 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 companies authorised to do so by Dürr Den...

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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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