Advance User Manual Vacuum (B) & Non
Contents
1. Advance User Manual P Prestige Medica Integrated deconbumnination solutions 304278B Instructions for use Please read these instructions before using the autoclave Keep these Instructions for use in a safe place close by the unit for future reference Service Helpline Telephone 01254 844 116 UK only 24hr e mail customerserviceQprestigemedical co uk Prestige Medical Service staff are available to provide advice and assistance during normal office hours To avoid delays when making contact please have the units Model and Serial Numbers at hand These can be found on the rating plate located at the rear of the unit or on the bezel inside the door For additional information visit www prestigemedical co uk Overseas Customers UK Customers Prestige Medical Limited East House Duttons Way Shadsworth Business Park Blackburn BB1 2QR Contact your local distributor In case of doubt contact Prestige Medical Tel 44 0 1254 682 622 Fax 44 0 1254 682 606 www prestigemedical co uk sales prestigemedical co uk Destination Kit Model no ee Serial no 304278B Date of purchase Vessel rating plate duplicate Contents Section Page 1 Introduction 3 2 Operating Symbols Displays and Controls 4 2 Operation 6 4 Essential Information 9 5 Routine Care and Maintenance 10 6 Trouble Shooting 1i 7 Recovery Sequences 12 8 Additional Information 13 92. The person who is responsible for the management of the equipment load assignment care and maintenance This person Is also responsible for ensuring that all applicable Health amp Safety Regulations are applied including those relating to the pressure vessel This person must verify that only suitably qualified persons undertake repair and maintenance work other than that described under Routine Care and Maintenance within this handbook Qualified person A person who Is qualified by training or experience to a recognised level in respect of the work to be undertaken Service Calibration and maintenance as required Manual handling Due to the weight of the unit two people are required when unpacking or moving the product UNPACKING When lifting the unit out of the box ensure there is one person on either side of the unit Lift out of the box and place on the work surface POSITIONING Start lifting by holding the unit below the front bezel large plastic moulding As clearance is gained lift at the other corners Place in position and release in the reverse order to lifting NOTE Always drain the water tank before moving Before moving always allow 30 minutes after use for the unit to cool down Cleaning materials Mild washing up liquid Non abrasive cream cleaner Disinfectant diluted in water Autoclave Cleaning Kit 289138 Product decontamination Should the unit require repair it must be dec
3. 10 minutes power will automatically be restored and the display will show Error 01 The load will need to be re processed ie start the cycle again Storage When leaving the unit standing idle for any length of time switch mains off amp drain the water tank especially if there is a possibility of the room temperature dropping below freezing point Packaging Packing materials used have been selected for ease of recycling Please ensure you use the correct disposal system for disposal of packing materials Maximum water usage Vacuum cycles 600mlIs per cycle typical Non Vacuum cycles 450mis per cycle typical Maximum power used 16litre 1 18kwh 304278B Section 12 Cycle profiles The profile below is for the 134 C 3v2min vacuum cycle ae RT E SY A E VE ASN 0 00 22litre 1 383kwh LEQ sound level 60db The profile for the ULUI 134 C 18min vacuum cycle differs only in the sterilizing hold time stage 7 to 8 The 134 C 3 5 min steam penetration test 7 i l r I is identical to the above profile but without drying Stage 9 to 10 Programme Step Time Temperature Pressure Cycle min sec Measured Value Measured Value identification cescoococoococoococoococooococooooosooocococococoococococcocooococoococooococoococococoocooocoooccoooocococoocoooococococosooococococoocoocococococococcococcocococcococococoococooocococococoococoooosococooooooooo eescococoocococcooc
4. EOEEE ESOL OOEET ESE ELEEEE EL ELELEDEDELELELEDEEE POCO H OREO LEEEEEEEEEE EE EOEEHEEESOOEE TE EEOEE EEE ESETEEE EE TOTEEEE ETE TEEEEEEEESOOEETEEEEEEEEEESELEETEEEELEEEEESELELELEDELEDELELEES 134 C 3v2min Vacuum cycle for porous loads wrapped pouched solid hollow instruments with drying My 134 C 18min Vacuum cycle for porous i o loads wrapped pouched solid hollow instruments with drying eecococcoosocoocoooooooooooooooooooosooooooooosoooooooooososoooooocoosoosooocooooocoosooooooooosoooooooooooooooooooooooooooooooooo 134 C 3 2min Cycle for bagged solid instruments without drying Additional drying should be added 134 C BYamin Steam penetration test without drying Suitable for Bowie Dick Test Pack or Helix POPPE HHO C EOE SEE HEH ESET ESOS TEE OEEET OTTO ESET TOO SETH PETE EETETH ETO EEOTE THEE SEEOEEETEHOE EOE EEHETOE ET ESEDESE EH SESOEE EEE ESELOEES 121 C 15 amin Non vacuum cycle for unwrapped solid instruments without 134 C 3v2min Non vacuum cycle for unwrapped solid instruments without drying POPP o eee eee e EEE LE EEO TEESE ESOL OSEOEEEHE EEO LOEHEOEEEEEEEE HE SEOEHETELEHEEEH ES ELETEHEDOOEEEH EEE LEEELEL EO LEEEE EEE LOLOL E EE ELOELOELE On non vacuum units pressing G allows you to scroll round all the 121 C and 134 C cycles POPP oo e SEE EEE EE EE EEE O LEE HOLE ETEEEEEEHEHECOEE EES EEELEEEHOTEOEEH EE EEHEEHEELETEEETE DELO EEEEDEELEOEH EH ELOLEEEEELELELEDELEDEEEES Non v
5. ESESETT THE EOET OT ETSESETEE TE EEEDESEEES 304278B ES The profile below is for the cycles br eC eg T Non vacuum cycle on a Vacuum Machine the only difference being in sterilizing Stage 3 to 4 125 BE Advance Pressure Profile 134U F m 3 gt 2 am 1 00 30 amp 00 30 Typical Point 2 750 mbar abs er in bold re FEE rem in both cases e 2 t0 3 11 00 amp 11 00 Typical Point 2 434 3 04 bar abs amp aami 2 05 bar abs 3 to 4 03 30 amp 15 30 Fixed 134 0 to 137 0 C 3 04 bar abs to 121 0 to 124 0 C 3 32 bar abs 2 05 bar abs to 2 25 bar abs 4to5 02 30 amp 03 30 Typical END 17 30 amp 27 30 Typical PCCP SLL E TEE E EE EEOEEEEEEHEE HEE EEEEEEEETETEEEEEHETEOETETETETEEETETEEEEEEEETOTEEE EE THTEHEHTEHESEEEHEEEEHTEOEEEH ETE SEEEEHE LED EOEEOEHETESELEEEELELELEEEEEE EEE LEH ESTEE HE EEEHETE EE ETEETETET TELE EEEE EE EEEEEEEE ELLE EELS On non vacuum machines the vacuum assisted fill is not present THE CYCLE PROFILES SHOWN ON THIS AND EARLIER PAGES ARE FOR THE 16 LITRE AUTOCLAVE 304278B Section 13 Water quality Must be suitable to produce steam in accordance with international standards Example specification for clean steam Determinant Value Recommended test for compliance Based on sterilized water for Injections BP ecoscococooooocoooooosocosocooosoooooooooosooooosooosocooocoocoooosoocoooooosooocooooocooooosoocoooososooooosoosooscosoocsocoosocooosocsooss
6. Warranty 14 10 Printer and data logger Instructions 14 la Specification 15 12 Cycle Profiles 16 We Water Quality 19 14 Loading the Autoclave 19 15 Daily Record Sheet 20 tJ Prestige Medical km Prestige Medical Limited East House Duttons Way Shadsworth Business Park Blackburn BB1 2QR Tel 44 0 1254 682 622 Fax 44 0 1254 682 606 www prestigemedical co uk salesQprestigemedical co uk BS EN ISO 9001 2000 ISO 13485 2003 Cert No FM31988 Cert No FM79156 Registered in England Reg No 2826793 Section 1 Introduction Thank you for choosing the Prestige Medical Advance Autoclave This machine is fitted with sophisticated control software and will automatically adjust the cycle time dependent on the mass of load used This will ensure the optimum sterilizing and drying conditions for all loads All Type B vacuum cycles use the triple pulse fractionated vacuum system Non vacuum cycles use the thermodynamic air displacement system Vacuum Drying cycles employ a closed door system Non vacuum machines employ an open door system An Auto cycle start option is included which allows the user to programme the time of day at which the selected cycle should start Before unpacking refer to the Manual Handling section on page 13 section 8 Whilst unpacking check the unit for transit damage If damage is found please report this to the shipping agent immediately in writing and the
7. and rinsed thoroughly Always use the instrument trays or racks which are supplied or are available as recommended accessories through your supplier Load instruments so that they do not touch other instruments or the chamber and are resting on the ribs of the tray Only one item should be placed in a pouch Pouches should be placed in the pouch rack which replaces the tray Refer to loading page 19 Linen loads should be formed into a rectangular pack of size 110mm x 110mm x 50mm maximum weighing no more than 1 kg Place on a pouch tray in the middle of the chamber Linen loads should not be sterilized in combination with other loads 8 Door closing Once the trays are in place close the door by pushing until a click is heard The LED next to the door open button C will then flash for a period of 20 seconds during which time entry in to the unit is restricted This dwell period is used to ensure correct pressure sensing readings are made prior to a cycle being initiated Access to the unit can be made once this period is complete 9 Cycle options After each cycle the unit will return to the default cycle On Vacuum units this is the 134 C 3 2min Vacuum cycle for porous loads wrapped pouched solid hollow instruments with drying B cycle Cycle options available on the vacuum autoclave are POPC ECL O EEE SEE E EEE OEEE EE SEEEHEESOOEEEE EE SEOEEEESSOEEEE TES OLEOEEESOTEEOEEEEOLOEEET EE
8. data logger MUST be fitted The test MUST be undertaken when the unit is cold and dry before any other cycle has been run Set the autoclave in Standby Mode by pressing ready button A The LED next to button A will illuminate Press and hold button F for 6 seconds The display L1 will begin to count down Hold button F until the count down reaches zero The test will then start 304278B During the test the segments of the cycle status graphic S1 will flash The test will take between 15 to 30 minutes On completion the print out will advise if the unit has passed or failed the test If a fail occurs clean the gasket and the chamber rim before repeating the test If the unit repeatedly fails contact Prestige Medical or your supplier To return to normal use press button A then button C Auto cycle start The unit can be programmed to enable any cycle to be started at any time of the day when the unit is unattended This option is recommended particularly when the operator performs Air leak detection test e Set the autoclave in Standby Mode by pressing ready button A The LED next to button A will illuminate e Press and hold button D for 6 seconds and release The time display L1 will flash with the default time of 06 30 being displayed e Press E2 to accept If another time is required for the auto cycle start change minutes then hours by pressing button D up and E1
9. down Accept by pressing button E2 e The unit returns to Ready Mode and the LED to the left of the clock symbol continues to flash e Select the required sterilizing cycle using buttons F G and H e Load the instruments in the chamber and close the door e Press the start button B The door LED C and the start LED B both flash The clock symbol LED is still flashing e The selected cycle will start when the programmed start time is reached The clock symbol LED flashes until the cycle is completed e To abort a timed cycle before the cycle starts press the Standby button A Section 4 Essential information To ensure that the autoclave continues to operate correctly it is important to adhere to the following points and to carry out the necessary care and maintenance procedures as specified This product is not a washing cleaning machine Do ensure that you read and follow these Instructions for Use the load is suitable for sterilizing and the cycle selected the load can be sterilized at the selected temperature the load has been cleaned the load has been rinsed thoroughly in clean water orior to sterilization to avoid any chemical residues left after cleaning contaminating the autoclave when placing instruments on trays ensure that they are placed on the ribs of the tray to help drainage they must not touch each other and must not interfere with other tray
10. 77 Autoclave cleaner Part No 289138 For cleaning the autoclave to ensure continued operation Air filter Part No 273096A Replacement air filter 3 Tray Rack Part No 289132 Set of two 10 instrument clip trays Part No 309081 Set of twelve 10 instrument clip trays Part No 309082 Set of three 5 instrument clip trays Part No 276395A Set of two 3 instrument clip trays Part No 276396A 304278B 14 Section 9 Warranty Prestige Medical Ltd will in the first twelve months from the date of purchase or 18 months from the date of factory despatch whichever is first repair or replace free of charge any parts inclusive of labour which prove to be defective in workmanship and or materials In the following twelve months Prestige Medical Ltd will replace free of charge any parts which prove to be defective in workmanship and or materials exclusive of labour This warranty cover is dependent on authorised servicing of the unit at least every 12 months and that Prestige Medical Ltd received the warranty card within 3 months of installation Prestige Medical Ltd will not be liable in the event that the purchaser has failed to adhere to the instructions contained herein or if the autoclave has been abused interfered with altered repaired or serviced by any unauthorised party This may result in the protection provided by the equipment being impaired This warranty excludes the door gasket all
11. AUTION Ensure the gasket is located the right way around on the plate the lip should face outwards During re assembly place new black sealing washers supplied with the gasket in the machined recesses in the door casting Ensure that the entry port plug aligns with the hole in the cast lid Prior to tightening the two thumb nuts ensure that the gasket Is correctly seated on the gasket plate and in the door recess DO NOT over tighten the thumb nuts as this may damage the thread section 6 Trouble shooting If the machine does not complete a sterilizing cycle a visual and audible indication will be given The reason can then be determined by reference to the guide below The recovery sequence allows access to any instruments within the autoclave and is the first step when rectifying the condition In the unlikely event that a cycle fails to complete instruments should be reprocessed as they may not be sterile UOD1 and UOD2 Unit contamination or gasket wear Conduct routine maintenance procedures Replace gasket If the condition persists an engineer call out may be required COOP SPOOLS EO EEE EEO LEE EEEOEEEHESOOEHE HEHEHE OEE ES HOHE ETHOTHESHHHEESEEOEEEESOOEEEESETEHSHOTEESOEHOT EH SOEEETOEHEESEOTHOTSOHHOSES HOOT OEOHOHEETHEEOOEEO OOOOH ESSOHEHTOTHOOEEE TES OLETOHE SOOO TE HEHEHE SHEET TE HEHE OEEETHE HOOT E EHO OELESE SOLED DELO OEEEDEELOLSESEEEOOEEEOS Low water LED E2 insulficient water to Tun a cycles 77777 Pre
12. Wrapped or pouched loads should not touch adjacent loads Pouches must be used for one item only When placing items on a tray or pouch tray ensure they are placed on the raised ribs to aid drainage that they do not touch each other and that the load does not touch other trays or the chamber in any way Always use the lifting device when removing trays or pouch trays from the autoclave as they may be hot Long trays should be supported at their rear as they become free of the tray carrier Pouched instruments should be placed on pouch trays for best drying results Do not use an unprotected hand to hold hot trays 304278B Section 2 Operating symbols displays and controls The following descriptions refer to the symbols controls and displays used on the ADVANCE range of autoclaves IMPORTANT Read Hot parts Operating Instructions Do Not before use Touch Symbols Fill water tank when LED illuminated S2 below Maximum fill level is WY ror acceptable water S3 opposite quality refer to Section 13 Do not use tap water S1 Cycle status graphic segments General controls Operations Note The function is selected when the LED adjacent to the button is illuminated Standby Ready button Cycle start button Door open button Select time date cycle counter Adjust time date settings E1 E2 Select vacuum cycles Select Non vacuum cycles Select Additional drying Fus
13. acuum cycle for unwrapped solid instruments with drying Either 121 C 15 amin or 134 3 2min Non vacuum cycle for unwrapped solid instruments without drying Either 121 C 15 amin or 134 3 2min POCO OO SSH OE HEE E EEE EEEESOO TEESE OT OEE OEEOTE TOOT OOS EE EES EHOOT EES EOOSE EE SEHOSETESHOESOTESEETOOT ESO OEEOO ET OES OSES EESEOOSEEESESESOEES This option can be added before or after a cycle NB Additional drying is inactive for the Steam Penetration Test cycle TP Drying on this cycle can only be obtained after the cycle has ended by selecting additional drying as described below in ii i To select before starting a cycle i Press button H once L4 illuminates to indicate 5 additional minutes ii Press H a second time L4 amp L5 illuminate to indicate 10 additional minutes iii Press H a third time L4 L5 amp L6 illuminate to indicate 15 additional minutes iv Press H a fourth time This cancels additional drying v Select then start the required cycle See 10 ii To select after a cycle has been completed i With the door closed press and hold button H for 10seconds L7 flashes to indicate 5 minute drying in progress ii Press button H once L4 illuminates to indicate 5 additional minutes Now press and hold button H for 10seconds L4 and L5 are illuminated Then L7 flashes to indicate 1Ominute drying in progress iii Press button H twice L4 amp L5 i
14. ated decontamination solutions
15. ature safety cut out IMPORTANT NOTE ON EMERGENCY DOOR OPENING PROCEDURES If the door interlock lever does not fully release during door opening and the door led has gone out light pressure on the door will re illuminate the door open led It will then be possible to open the door in the normal manner using the door open button Door opening Power loss If the machine has suffered a loss of power and it is essential to open the machine to remove instruments the following procedure should be followed This should only be performed by the nominated responsible person 1 Disconnect the unit from the mains supply 2 Allow the machine to cool down to room temperature 3 Remove the protective white protective cap on the top of the machine A Using the hook on the special tool release any pressure vacuum inside the vessel by hooking the ring on the pressure relief valve and pulling this towards you As shown opposite 5 Insert the straight end of the special tool into the interlock lever release guide hole and push inwards If the tool starts to buckle at the preformed strain relief repeat from 3 above See Photograph opposite DO NOT ATTEMPT TO OPEN THE VESSEL IF PRESSURISED ONLY USE THE TOOL PROVIDED AND FOLLOW THE INSTRUCTIONS ABOVE TO GAIN ACCESS TO THE MACHINE Door release tool hole 304278B Section 8 Additional information Operator The person assigned to use the autoclave Responsible person
16. component materials Vessel Stainless Steel 304 S15 Boiler Aluminium LM25 Lid Aluminium ASME SB26 356 0 16 Door Plate Stainless Steel 304 S15 Fuses Located at the rear of the unit under the access panel I WARNING Disconnect the autoclave from the mains power supply before changing fuses Only qualified personnel should replace fuses Fuse type M12A 32x6 3mm Ceramic sand filled 230v Mains plug top fuse user replaceable F13A to BS1362 UK only Rating All products are rated for intermittent use continuously Heaters Cast into the boiler Internal heater Temperature cut out Bi metallic type rated at 180 C with automatic reset Pressure release valve Operates at 2 9bar Accumulation is lt 10 Maximum single fault temperature 143 C determined by the pressure release valve Over voltage category Group Il Pollution degree Group Il Insulation Class I Environmental conditions Indoor use at an altitude of up to 2 000m Ambient temperature range 10 C to 40 C Maximum relative humidity 80 for temperatures up to 30 C decreasing linearly to 50 at 40 C Mains supply voltage range 207 to 254volts Drying performance maybe affected by local environmental conditions Safety shutdown The machine is fitted with an automatic thermal reset mechanism In the event of the boiler overheating for example due to accidental overload the unit will power down After approx
17. ens Year hundreds Month Day Minutes Hours e Set the autoclave in Ready Mode by pressing ready button A The LED next to button A will then go out e Press and hold button D for 5 seconds e Set year tens by pressing button D up and E1 down Press button E2 to accept e Set year hundreds Month Day Minutes hours by pressing button D up and E1 down Press button E2 to accept for each e The unit returns to Ready Mode when the hours are accepted 5 Ready Press button A to set the autoclave into Ready Mode The LED next to button A will go out Note When in Ready Mode the boiler and chamber are kept warm 6 Water fill DO NOT USE TAP WATER Before using the autoclave for the first time fill with water Press button C to open the door Pour water into the fill soout M until it reaches the Maximum line S3 Do not overfill The water capacity is 3 7 litres When the low water indicator illuminates top up with water Always use de ionised distilled or sterile water as recommended see page 19 NEVER USE TAP WATER THIS WILL INVALIDATE THE WARRANTY 7 Loading Refer to Loading the Autoclave at Section 14 page 19 and Specifications on page 15 for the maximum permissible load Failure to follow instructions may cause the unit to malfunction and result in an unsuccessful cycle Before loading ensure instruments are cleaned
18. epeat the cycle meme 07 Sensor fault Boiler thermistor Recovery Sequence ii Repeat cycle If fault persists engineer call out May be required meme 08 Sensor fault Pressure transducer Recovery Sequence ii Repeat cycle i fault persists engineer call out May be required mente 10 Water in the boiler recovery ee EN 13 Water fill time out Recovery sequence i Drain water out of the fresh water tank and refill with de lonised distilled or sterile water Repeat the cycle mm 14 Sensor fault Chamber probe Recovery Sequence ii Repeat cycle titi O G If fault persists engineer call out may be required meme 15 System Leak Recovery Sequence ii Clean gasket and chamber face then repeat the cycle ene If fault persists engineer call out may be required meme 16 Low Induced leak rate NHS ONLY Seek advice from Responsible person meme UOD3 Vacuum failure in drying stage Recovery sequence i Contamination or wear of the gasket Clean or change gasket If fault persists Engineer call out required As non warranty related calls can be expensive it is advisable to ensure that all consumable items have been replaced or cleaned as appropriate and that the water quality is as described in Section 13 before contacting Prestige Medical Ltd For Engineer Assistance Call the Service Help line 44 0 1254 682622 24hr email service prestigemedical co uk 304278B 12 Secti
19. es located behind access panel Printer socket Main door not shown Fresh water tank drain Water fill Air filter Rating plate O22 Fr AS aco mlm 2 oO wv P Og Prestige Medical Se Osho eee k 304278B Cycle controls vacuum models AFTER EVERY CYCLE THE UNIT RETURNS TO THE DEFAULT CYCLE TEESE 6 Section 3 Operation Please take time to read these instructions before using the autoclave It is essential that the operator is correctly AN trained and a Responsible Person has been assigned for the management of the autoclave By following these 1 Installation Ensure the unit is placed on a strong flat level amp heat resistant surface To check if the unit is level pour half a cup of water into the chamber The water should flow towards the hole at the rear of the chamber not out of the front WARNING The autoclave is heavy at least two people will be needed to lift it 2 Connection Plug the unit into the mains outlet socket of the correct type amp rating See rating plate O Push the on off switch on the front of the unit After a few seconds the LED next to button A illuminates and the internal heater operates to control the internal temperature at a set value WARNING The mains outlet MUST BE EARTHED GROUNDED The mains plug should always be easil
20. internal furniture and consumables Consumer s statutory rights are not affected The Prestige Medical Ltd policy is one of continuous development and as such reserves the right to change the specification of the models and items illustrated and described herein at any time 304278B Section 10 Printer instruction Power on procedure Connect the printer to the power supply and switch on at the mains The LED light will illuminate on the printer Connect the printer to the autoclave with the supplied cable The printer connection at the autoclave is connector J see page 4 Replacing Paper Roll Part Number 279505 If the paper roll needs replacing open the paper cup lid and remove the remaining paper using the button do not pull paper through the printer mechanism Reel off a few centimetres from a new roll and check that the end has a clean straight edge Slide the leading edge of the paper through the paper entry slot with the leading edge feeding forwards from the bottom of the roll until you feel resistance Press the button and feed paper through the paper exit slot Sit the new paper in the paper cup and close the lid Should the paper become creased or out of line when feeding in a new roll cut the end off the paper roll feed out the creased paper using the button and reload ensuring the paper has a clean straight edge Status LED The printer incorporates an LED indicator to report its condition If the
21. lluminated to indicate 10 additional minutes Now press and hold button H for 10seconds L4 L5 and L6 are illuminated L7 now flashes to indicate 15minute drying in progress 304278B 10 Start cycle Press button B to start a fully automatic cycle visual display shows the stages of the cycle Stage 1 Cycle started L4 Stage 2 Heating and air bleed L5 Stage 3 Sterilizing L6 Stage 4 Depressurisation drying L7 Stage 5 Cycle completed L8 11 Opening door At the end of a cycle a buzzer sounds 3 times Press button C to open the door allowing access to the load Additional operations Steam Penetration Test On vacuum units the Steam penetration test should be performed on a daily basis to confirm that the unit is operating correctly A Prestige Medical Bowie Dick Test Pack or an Albert Browne Test Helix MUST be used with this test The Pack or Helix should be placed on an instrument tray in the middle of the chamber towards the front Albert Brown Test Helix Bowie Dick Test Pack Run the cycle for the steam penetration test Following this test the Test Pack or Helix TST should change to a uniform purple colour If the TST is not a uniform purple colour check the door gasket and vessel Repeat the test If the test fails again seek technical assistance Vacuum system leak test The vacuum system leak test checks the integrity of the vacuum system NB A printer or
22. n all EU based manufacturers and importers to take back electronic products at the end of their useful life x Prestige Medical Limited accepts its responsibility to finance the cost of treatment of redundant WEEE in accordance with the specific recycling requirements The symbol shown below is present on all Prestige Medical products which indicates that the product must NOT be disposed of with other waste Instead it is the user s responsibility to dispose of their waste electrical and electronic equipment by handing it over to an approved reprocessor or by returning it to Prestige Medical for reprocessing For more information about where you can send your waste equipment for recycling please contact your local city office or Prestige Medical 304278B 10 Section 5 Routine care and maintenance WARNING Disconnect the autoclave from the mains power supply before cleaning DAILY MAINTENANCE Gasket THE GASKET MUST BE CLEANED ON A DAILY BASIS BEFORE USING THE AUTOCLAVE _ Wipe exposed surface of the gasket and y the surface of the vessel with warm soapy water using a lint free damp cloth Wipe both the gasket and the vessel again with water using a lint free damp cloth to remove any residual soap EVERY 250 CYCLES Clean the autoclave using Autoclave cleaning kit Part No 289138 WARNING Failure to perform these procedures may result in the unit showing UOD1 on
23. n notify your dealer Product contents comprise of the following e Autoclave with internal furniture e Instructions for Use and warranty card e Performance Test Certificate and Certificate of Conformance for pressure vessel all UK models e Installation sheet e Written Scheme of Examination UK models e Waste water container e Printer or Data Logger if applicable Type B units will also contain a Bowie Dick Test Pack All Customers when you receive your Advance autoclave ensure that you complete and return your Warranty Registration Card Types of load and loading Advance autoclaves are designed to sterilize instruments utensils and other items as defined by the European Standard EN13060 Only the vacuum models can effectively sterilize wrapped or pouched instruments and hollow loads The autoclaves operate automatically with 134 C and 121 C sterilizing temperatures with or without drying For a full list of sterilizing cycles and times refer to Section 12 WARNING Refer to the instrument manufacturer to ensure the instruments suitability for autoclaving and the maximum temperature they can withstand A responsible person must qualify other loads as suitable Refer to Additional Information in Section 8 Refer to Technical Specifications Section 11 for the maximum instrument load for the autoclave All instruments must be cleaned appropriately prior to sterilizing
24. on 7 Recovery SEQUENCE allows instruments to be removed from the unit Recovery Sequence allows instruments to be removed from the unit Press button A Press button A Press button A Stabilize no flashing or bleeping Stabilize no flashing or bleeping Stabilize no flashing or bleeping Service required NB Cannot proceed Switch off at mains supply Press button A to enter Ready Mode Press button A Recover Service required The Recovery sequence depending on where the fault occurs will flush the water from the boiler and eventually complete the cycle with a continuous bleeping to indicate recovery is completed Important Before restarting a cycle check that the mains plug is fully inserted into the mains outlet socket and the outlet is of the earthed grounded type Should all power be lost the door cannot be opened until power is restored and pressure returned to ambient Should an internal power failure occur the door cannot be opened until Je The unit has cooled down to atmospheric pressure Access can then be made using the supplied tool 2 A service has been carried out In the event of failure of an indication device a service will be required to correct the condition Should a safety feature operate unplug the unit and call for a service do not attempt to correct the fault Primary safety features Two primary features have been fitted a pressure release valve and a boiler over temper
25. ontaminated in accordance with a recognised procedure prior to return or on site repair A statement of equipment contamination status must be available with the product Details of a suitable procedure are available on request from Prestige Medical Ltd Approvals Approvals are all model specific However the following standards apply in whole or part Medical Devices Directive MDD 93 42 EEC Electro Magnetic Compatibility Directive European Sterilizer Standard EN13060 Pressure vessel to ASME Section 8 BS EN 61010 Parts 1 and 2 UL CSA 3101 Spares Only those spare parts supplied or specified by Prestige Medical should be used in the maintenance of the autoclave Use of unauthorised parts will invalidate any warranty and may adversely affect the performance or safety of the unit Accessories Consumables Printer Part Nos 279519 Europe 279520 UK 279521 Australia Data Logger 279565 Optional and can be fitted by the user Printer roll Part No 279505 Ten replacement rolls Furniture 22 litre pouch tray Part No 309071 16 litre Pouch tray Part No 309066 Tray lifter Part No 279007 Door tool Part No 309068 Door plate thumb screw Part No 279300 Set of 4 gaskets Part number 279571 OQ Ring door Part No 279100 Waste Water Container Part No 279503 Container for single use water Bowie Dick Test Pack Part No 309031 Helix Test Pack Part No 329001 TST strips Part No 2592
26. ooooooooocoooocooooooooososooooocococoooooocoocooocooococoooocoooooocooosococoooooocoooooooooooococoooooooocococoooococococcocococoocooooooococooocoocoocococococooocoococoocoooooooocoooocoooooo cocoooooocooooooooocoococoococoososoooosoocoooocoooooooooococoocooososoooocooocosoococoocoooocoosocoooooooooococoocoososoooooocosocoooooocosooooocsosoocosoocoocococosoococococoosoosocoocooooooocoocooooocooooooo eooooooosocosocoooocoooocooooooooooocoosoooosocooooooosoococoooooooosocoooooocosocoocoocoosocosoooooooooosooooooooooooooooocooosooosoooooooooocosocoosoocooooooosoococoocoosoosocoocooocoooooosoooocooooooo socoecococeooocoooocoooococooooccooocoooocoooooooooooooocoooooooooocoocooooosooooooocooooeoooosooooooooooooooooooooooooooooooooooooooooooocooooooooocoooocooooooocooooocoooocoooooooooocooooocoooocooooocoooooocooooocooooooocooooooooooooooooooooooooooo 304278B The profile below is for the 184 C BYemin cycle for Bagged solid instruments If ie NB Additional Drying must be added to this as detailed on page 7 7108 15 00 Fixed ADDED DRYING NOT SHOWN ABOVE Could also be 05 00 or 10 00 depending on the amount selected POPS HOSES EEE EEHEHEE SESE SESESOHET ETE E ESOS ETT OO ETOT TEETH OESOET TES EETO TTT ETEET SET OOE STOO ee eee eee TOSSES OLS ETOOT ESO SESE eee eee eee TO SEOETE TOSS OES TO eee eee eee eee eee eee eee eee eee eee eee eee eee eee eee eee eee EES eee eee OTT
27. osoosoosoccoocosesocososoossosocosoosocosooooosoocoooocsosocooocooocoooooosoocoooososocoooooooooooooosoocoooooosooooooooooooooooooo Acid or Alkalinity NQ BP test Tests for pH are not an acceptable substitute ee 5 pe NER EE Spe care ge Team mre a a a lt EE FT re tense cenit a a NT tN A Se eae oe ey emai acceptable substitute FE el 5 FESTE SE SEE EEE an acceptable substitute are EEE rn FT Oe ee eee Si ee meen te mere TN ET eI a A a EE REE a ie Re an car inai Re ay Fa dr ee FE KL fn sn acceptable substitute re el OE JE acne a EEE ES a rea aE Fr Hen Be SAS et ame E E A Nae rey FN KR ee ee j E ke heel Ke Fe sss RR H er 5 T eee NQ Not Quantified BP British Pharmacopeia EU Endotoxin unit Consideration should be given to single shot type sterilizers where water is not returned to the reservoir at the end of the cycle PCCP OOO C EEE EEHE TEES OEEETE EOE SOOO E TE EHESETOEESOSEOT ESTES OOH ETOEHESOT OTTO SOOT OE SES OOO OTS OEEOT OST OHSE ESO OOH ETEEHOSEEESEHOT TSO S ESSE TT OT OEE ES TOES OTE SESH SOTE SHOES TOS ETOT EEE eee eee eee eee eee SOSEET OTS ES HOOT ET OETOSET EE SOSEEEH ES ETOSOTTETOSHOTET EES OSEEEE EE ESESOSEELES USE OF WATER OUTSIDE THE ABOVE SPECIFICATION MAY INVALIDATE THE MACHINE WARRANTY section 14 Loading the autoclave Loading has a significant impact on how the autoclave Pouches should be arranged so that they do not touch or performs overlap neighbouring pouches The maximum permi
28. re is a fault the LED will flash in sequence The fault can be identified by counting the number of flashes LED Condition Solution Printer ON n Printer Off or Asleep Faen Paper QU Fit new paper S cecococcococooooocooocococooocooooooococococoocoocoococoooocococococcococococococococoococoocooococococoooocoooocoocooooooooocooooooooo Place the printer on the worktop at the side of the autoclave Do not place the printer on the top of the autoclave Make sure the paper is kept away from hot surfaces such as the dump pipe etc Store the printouts in folders away from direct or indirect sunlight Data logger instructions Refer to the instructions supplied with the data logger for setting up and operating the data logger Section 11 Specification Overall product width 480mm 480mm Fo EE er DEE ae ee FT a Fr EE a A E e E ee GE ey Kne Fe re wl Bee en Er re tenner ee ee er EE i ae yaa ee He O Fe EE EG ee En ne ie sa de eee eC 7 re ised stehated Max load vacuum 6 kg un pouched 6 kg un pouched Pack size 2 kg pouched 2 kg pouched 110x110x50mm 1 kg porous 1 kg porous eT ane a Fre DE ER a TT 134 C 18mins 134 C 18mins 121 C 15 mins 121 C 15 mins Ms ar a 5 e ae 5 Me skred Minimum Aa mr Leer ae ee i i ae i eee Fm re ee Menem o E ae kl NB The overall cycle time will increase as the mains supply voltage decreases Chamber
29. s or the chamber above only distilled de ionised or sterile water is used as recommended on page 19 the autoclave is in a draught free area the autoclave is not installed in an enclosed cupboard space the door is left ajar when not in use you quote model serial number which are located on the lower left hand side of the front bezel behind the door moulding and also on the rear case just above the mains power cord entry and date of purchase in all correspondence only qualified personnel regularly service the autoclave It is recommended that a Chemical Indicator strip be used every cycle to verify that the sterilizing cycle is effective If the Chemical Indicator strip fails to change colour repeat the cycle If it still fails to change colour then arrange for a service Do not lose this handbook add any chemicals whatsoever to the water attempt to sterilize volatile substances toxic materials or other unsuitable loads Refer to your Responsible Person for advice place the autoclave in direct sunlight place the autoclave on heat sensitive surfaces use inappropriate cleaning materials drop or abuse the autoclave use in areas of risk associated with flammable materials or gases remove the casing or attempt to service or repair the autoclave Disposal WEEE Statement Waste Electrical and Electronic Equipment The WEEE directive places an obligation o
30. ss button A twice Top up with water to mark 53 eee door illuminates Cycle start button pressed whilst door If door closed but door LED C not illuminated push on door to see if LED on display L2 is open or door micro switch requires can be illuminated adjustment If door open close door and try again If fault occurs during a cycle follow Recovery sequence i p E a taintncat a E a FE NN NE unit switched off prior to cycle completion Check power supply repeat the cycle ae se E AE FE RT Contamination of Sensors Clean gasket and chamber face then repeat the cycle Contamination or wear of the gasket If fault persists engineer call out May be required on nannase d02 Probe temperature difference out of Recovery sequence i range Conduct routine maintenance procedures Clean gasket and chamber face then repeat the cycle iii TT If fault persists engineer call out may be required cee t02 Clock error Recovery sequence i Check amp rest the clock repeat the cycle If fault persists engineer call out required p02 Sterilizing Pressure out of range Recovery sequence i Clean gasket and chamber face then repeat the cycle If fault persists engineer call out required csnusseaetnstnuanse 03 Air bleed has not been successful Recovery sequence i OSSES O Clean gasket and chamber face then repeat the cycle mm 04 Vacuum failure Recovery sequence i EE Clean gasket and chamber face then r
31. ssible loads are as follows If using pouch trays these should be spaced so that there 6 kg for Non Vacuum Cycles is a good airflow between the trays 6 kg for Vacuum cycles un pouched When loading the trays into the rack use the top rungs of 2 kg for Vacuum cycles pouched the rack first and work down 1 kg for Vacuum cycles porous load Pouches should be placed on pouch trays with the paper Always use the instrument trays or racks which are side down as shown below supplied Load instruments so that they do not touch other instruments or the chamber and are resting on the ribs of the tray Only one item should be placed in a pouch Pouches may be placed on the Pouch Trays provided additional trays may be purchased as an optional extra 304278B Section 15 Daily record sheet Advance Autoclave If printer fitted staple print outs to the sheet L OAD TYPE CYCLE DATE CYCLE NUMBER PASS OR FAIL OPERATOR See KEY below SELECTED KEY FOR LOAD B Hollow P Pouched U Unwrapped M Mixed TYPES Instruments or bagged Instruments Instruments If a cycle fails record the Error Code in the Pass Fail column For Engineer Assistance call the Helpline 01254 844 116 e mail customerservice prestigemedical co uk Always quote your Model details Serial Number and date of purchase when contacting Prestige Medical or your Supplier See page 2 of this manual eP Prestige Medical 304278B Integr
32. the display UOD1 indicates that the unit may have been contaminated and could fail to operate correctly EVERY 500 CYCLES Change the air filter situated at the N front of the autoclave YS Exterior surfaces should be cleaned with warm soapy water using a damp cloth Gently unscrew the filter and fit the replacement Exterior surfaces as required For persistent marks use a gentle cream cleaner Fresh water tank Waste water container On a monthly basis fully drain the water tank and leave overnight use Autoclave cleaning kit Part No 289138 Drain then refill with fresh water Repeat this operation twice more to remove any residue Always use de ionised distilled or sterile water as recommended NEVER USE TAP WATER 304278B Routine maintenance Annually replace the water filters Gasket replacement Should the gasket develop a persistent leak it should be removed cleaned thoroughly in warm soapy water and shaken dry Wiping with a lint free cloth is acceptable Other materials may lead to contamination of the gasket with fibres The door gasket plate must also be cleaned If the leak persists you should obtain and fit a new gasket To remove the gasket undo the two thumb nuts 809070 in the centre of the gasket plate Sealing Lip ensure the gasket is orientated correctly Entry port plug Remove the plate gasket assembly and then remove the gasket from the plate C
33. y accessible as it is to be relied upon as the means of disconnection 3 Single use water system This unit has a single use water kh system designed to prevent the gt recycling of any contaminants which may be present on the instruments being sterilized Ensure the waste water container y is checked regularly to prevent tt overflowing The container should be a emptied when the waste water level reaches the Max line To empty the container undo the screw cap and carefully remove the steam condensing coil which passes through the cap Place on a heat resistant surface whilst emptying the container Use the carry handle to support the container when emptying Replace the steam condensing coil and cap ensuring it is screwed on securely 304278B simple step by step instructions you can ensure your instruments are correctly sterilized every time Note Before using for the first time and after emptying always add cold tap water until the level reaches the minimum level mark The waste water container can be located in any convenient place provided it is at a lower height than the autoclave although care should be taken that it cannot be knocked over WARNING Waste water and steam condensing coil may be hot Care should betaken at all times 4 Setting date and time Date and time are set in the following sequence Note This unit uses a 24 hour clock Year t
Download Pdf Manuals
Related Search