Alpha User Manual 22 litre Non Vacuum (N
Contents
1. 7 Loading Refer to Loading the Autoclave at Section 14 page 15 and Specifications on page 14 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 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 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 Non vacuum cycle for unwrapped solid instruments with drying Either 121 C 15 min or 134 3 min Pe eee ee reee onrrrrncrrnnnncrrnnenrrcnrnnnnrarnnnn cercare ncnccrnnnncrnncnncrrn nr EO LEEELEE EE cnn o o Non vacuum cycle for unwrapped solid instruments without drying Either 121 C 15 min or 134 3 min error SETS EEE HELE EOEEE ES EEOEH ETE EEEEH ETHEL EOEEEETEEEEOE HE EETEEO EET OEESEH EO EEEEEH ERO ESOEEE EE E2. 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 easily 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 system designed to prevent the recycling of any contaminants which may be present on the instruments being sterilized Ensure the waste water container is checked regularly to prevent overflowing The container should be 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 274454A 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 a
3. Press button C to open the door allowing access to the load 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 Set the autoclave in Standby Mode by pressing ready button A The LED next to button A will illuminate 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 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 down Accept by pressing button E2 The unit returns to Ready Mode and the LED to the left of the clock symbol continues to flash Select the required sterilizing cycle using buttons F G and H Load the instruments in the chamber and close the door Press the start button B The door LED C and the start LED B both flash The clock symbol LED is still flashing The selected cycle will start when the programmed start time is reached The clock symbol LED flashes until the cycle is completed To abort a timed cycle before the cycle starts press the Standby button 4 274454A 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 o
4. below SELECTED 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 amp Prestige Medical 274454A Integrated decontamination solutions
5. re Recovery Sequence 11 8 Additional Information 12 9 Specification 13 10 Cycle Profiles 14 14 Water Quality 15 12 Loading the Autoclave 1s il Warranty 19 14 Daily Record Sheet 16 7 Prestige Medical Integrated decontamination solutions CE 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 sales prestigemedical 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 Alpha 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 Non vacuum cycles use the thermodynamic air displacement system and employ an open door drying 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 12 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 then notify your dealer Product contents comprise of the following e Autoclave with internal fu
6. 2 Operating symbols displays and controls The following descriptions refer to the symbols controls and displays used on the ALPHA range of autoclaves IMPORTANT Read Hot parts Operating Instructions Do Not before use Touch Symbols Fill water tank when LED illuminated Maximum fill level is S3 opposite o gt Do not use tap water E S2 below For acceptable water quality refer to Section 13 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 Non vacuum cycles Select Additional drying Fuses located behind access panel Printer socket Main door not shown Fresh water tank drain Water fill Air filter Rating plate P r ASTI AM eo oS LJ Prestige Medical z Sy Cira OA 274454A Cycle controls Examples below show Press H to select Additional Drying AFTER EVERY CYCLE THE UNIT RETURNS TO THE DEFAULT CYCLE Non vacuum cycle for unwrapped solid instruments without drying Non vacuum cycle for unwrapped solid instruments with drying COPS O OSLO reecnnnrrrrnncrnnncernncrcrnrccrnncrrnrccrcrn cnc cnc ccnnncrrcnnconnnnrccnrncrn ccr o The 121 C or 134 C led will be illuminated to s
7. Alpha User Manual cuum N a A A j Prestige Medical g i m r i y X y A I AAA A UA y E A Integrated decontamination solutions 274454A 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 customerservice prestigemedical 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 ae Serial no 274454A 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 8 5 Routine Care and Maintenance 9 6 Trouble Shooting 10
8. Cleaning Kit 289138 Product decontamination Should the unit require repair it must be decontaminated 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 274454A 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 EN1 3060 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 tray Part No 309071 Tray lifter Part No 279007 Door tool Part No 309068 Door plate thumb screw Part No 279300 Set of 4 gaskets Part number 279571 O Ring door Part No 279100 Waste Water Container Part No 279503 Container for single use water TST strips Part No 259277 Auto
9. EELESERELESEL ELE LE LE DERE EEO E EEO This option can be added before or after a cycle i To select before starting a cycle i Press button H once L4 illuminates to indicate 5 additional minutes i 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 10minute drying in progress iil Press button H twice L4 amp L5 illuminated 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 10 Start cycle Press button B to start a fully automatic cycle A 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
10. OH OSHS EEO SETOEEHETOT OSES OTSEEHETSEEOEHEETHSEHTH TS OHEEEHOEEEHEOOSEEEEEEEEE SPOS TEHEEEE SOE EEEEEEEOEEESHSEEOE SHOE HHEHSOHSO SOSH SHS HHEESSOHSEHSOHHHHSHOHEOSSHSHHSOSHOHSHEHOTOHHOSHSHHSHHHOHSHT SEES ESOESOTHEHHHHSSHHEHTES SOOTHE OOOH E OH SEHOEOT SOHO TO SHOE OSHSEEOHETSOHOEHEOSEOOEHTHSEEOTESEEEHEOTEOHEESE SHEET ESEEEHEHETOSEHEEESOEEEDELEOOLESESEEEDESENR Recovery sequence i Drain water out of the fresh water tank and refill with de ionised distilled or sterile water Repeat the cycle OOOO OCC CIC OOICU IC IOOICIUIOIC ICCC ICICI ICICIUO COICO IOIC CIC ICIOIOIC IC IOIOIUIO ICO IOIOIOIC OCC COC CCC IOIOIOU CCCI CUO ICO OO a Recovery Sequence ii Repeat cycle If fault persists engineer call out may be required POCO S OSE EE EOE EEE E OEE EO HOES SHOOT EELESHHST HEHEHE E SHOE THHOEHEEEHHHETOHHEESHEHETESEOHEESEEHEHETOHHETH HTH ETOEHEE HOHE OLOTHOSSOOEEEEEOHOOEHELEOEEETOEOEETSEOOEHEETOHHOETOSHOETEOOLEHEHSOHEEHETESHEEEETELEEHOE HOHE EE HEHE EE HELO OEE EH OSLO EEEOOEDELEOLEEEEELEOEDELOLE Recovery Sequence ii Clean gasket and chamber face then repeat the cycle If fault persists engineer call out may be required Clean or change gasket If fault persists Engineer call out required PPC CELE EEE ELE EOE EEESEEHEEEEEHEESEEHEH OTTO ETEEEE ET TETTEETETEEH TEETH ETETET TET TET EET OTET THOSE rro rro rosso EEEH OEE L EEE ORL EES As non warranty related calls can be expensive it is advisable to ensure that all consumable i
11. 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 274454A Disposal WEEE Statement Waste Electrical and Electronic Equipment The WEEE directive places an obligation on all EU based manufacturers and importers to take back electronic products at the end of their useful life 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 Section 5 Ro
12. atures Two primary features have been fitted a pressure release valve and a boiler over temperature 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 274454A 12 Section 8 A
13. ble loads are as follows In the following twelve months Prestige Medical Ltd will 6 kg for Non Vacuum Cycles Always use the instrument trays or racks which are supplied Load instruments so that they do not touch other instruments When loading the trays into the rack use the top rungs of 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 his may result in the protection provided by the equipment being impaired This warranty excludes the door gasket all 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 274454A section 14 Daily record sheet Alpha Autoclave If printer fitted staple print outs to the sheet the rack first and work down L OAD TYPE CYCLE DATE CYCLE NUMBER PASS OR FAIL OPERATOR See KEY
14. clave cleaner Part No 289138 For cleaning the autoclave to ensure continued operation 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 two 3 instrument clip trays Part No 276396A section 9 Specification Overall product width 480mm he ene Porc eae le Far aaa oe Pt E a Tee PAR E EE N E aN See eee al pia ane a o e o ia ee eee Le ee T pues a ee i ian E e A a Rh Os A ere ree 134 C 18mins 121 C 15Yamins eRe Tea Pe aes 5 e de E a A a ER E AN EEEE PTNT a cara NB The overall cycle time will increase as the mains supply voltage decreases Chamber component materials Vessel Stainless Steel 304 S15 Boller Aluminium LM25 Door Aluminium ASME SB26 356 0 T6 Door Plate Stainless Steel 304 S15 Fuses Located at the rear of the unit under the access panel 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 fa
15. cosocoococooococooocooosoooooooococooocococoosococosocoooooocooooococooosocooosoocoocooococococooooocooocosoocoooooooooooooocosocococosoooooooooooooooo range 659 Recovery sequence Conduct routine maintenance procedures Clean gasket and chamber face then repeat the cycle If fault persists engineer call out may be required 66599 Ke Recovery sequence Check amp rest the clock repeat the cycle If fault persists engineer call out required 66599 Ne Recovery sequence Clean gasket and chamber face then repeat the cycle If fault persists engineer call out required PPPOE T ESE EE EEO LE OEE EEO EEE EO EEOE EES OOEEEEEOTHEE HOHE SESEOEESE SHOE TELOHHESEOEHESHEHOTHTSHESETEEOHEHSOOHEEH OTHE ESEEHHE SOHO OEEETOS SOOO ESE OOOETHELOOEEE SOHO EE HE SOOOEOTEOOHEOTOSEHETE HOHE E SHOES HOEEHTE HOLE HESOHEHTEHESOETEH HEHEHE HOSEOEHOSOLEDELELEEEEE ES EOEDELOLS 659 e Recovery sequence Clean gasket and chamber face then repeat the cycle COOH OS HEHEHE HEHEHE HEEHEEEOEHEES cnn encnnnccranrccannncnsnnccnnncranan cnn nn cnc nnnnnncccrrnnccrrnn nan can nenccrnnncncr cso Recovery Sequence ii Repeat cycle If fault persists engineer call out may be required Recovery Sequence ii Repeat cycle lf fault persists engineer call out may be required CO OCOS EHS EEEEEHCEEEHOEHOEEOOHSEEH ET HOEOOHEEHSEHSHHEHHSHTEESOTHOESEH OE HEHHSHHEHTOT TEESE H cennnnscrnrrnccnan recen cnn SS OHOET OO SOEHO OH OEHHEEHOEHEHHOSO
16. dditional information Operator The person assigned to use the autoclave Responsible person 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
17. how which cycle is selected L1 Display for Time Date amp Cycle counter The normal display mode is time The date or cycle counter can be selected by pressing the button D adjacent to the display The selection is valid until a cycle is completed or until the unit is returned to standby mode at which point the display will revert to the current time 134 C Non vacuum cycle with drying L2 Display for Temperature L3 Display for Pressure L4 Cycle started L5 Heating and air bleed L6 Sterilizing L7 Depressurisation drying L8 Cycle complete 274454A 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 ByN RO 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
18. ith 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 CAUTION 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 274454A 10 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 ga
19. n Measured Value Measured Value be e P lt at oe i fa eae Fete T SE 1102 11 30 amp 11 00 Typical Point 2 3 04 bar abs amp 134 C IO ia a aa 121 0 to 124 0 C 3 32 bar abs Figures in Red A IDA nnn 0230 8 03 30 Typical smnsnunnnsnunnannnannnnnnnnna a a i730 8 37 30 Typical ee REE en a E ter conoce ener nn ncnn eenoennnnn nnncnrnnnn encencnen c cecncrnnncnnc nce ce cennn eoccecocoocoocoooocoocooccococooococooccoccocococooococoococoooooo ecocococo eevee eocccocoocooooo ecocooo eoccococooccoccocoocooocooooo 21714454A section 11 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 corro oOo SEE EEE HE HEOEEE EEO EEEEEE cnc ccrrrn cnn enconnrcnncrrrnn concerns cnc ncrnnrnncrrrnncccannncnennncrcrrrncrncannocnnnnrrrcnnrrnccnnnncncrnnncccnnncocnrnncrrcrnnnconcnrcrcocnconsncnnecncncn cn o Acid or Alkalinity NQ BP test Tests for pH are not an acceptable substitute o aa A a T a eg a ce ere ma E eee eae A Og a TUNE ff A o ERC rea Ae oar Reunions E AI ene See ean a ns a E E ara T E E el ae eerie E a A E el E Te oe Sat aa eae ae gee er ogee an nee SESH ae ieee eee c e A eT RT cone ee tee ee mE vee E ae A NE Re A A A a A ann cr RE oe eS ieee rane NA OT 3 O ao morada e e dla eco le corno rc
20. o onoonnrnecrrrrnccrncorcrncnconnnnocrrrnncrcn cnn cnncoocnrrrrnencrnnneocrcrrnnccrrnnncnnnnnorcrrrnnncnnnccnnoncrrcnrnncrcrrnn cnn encncrrnrnncrcrcnnnnnnnnnrcrcnnrnnccnnn noc ccenencrcnrcrn cnn corn HELE LEED cn cncren neo o corro orreroeoonneooorrrnncrrrrrcccn cn connnnooncrnncrrrrroccnno ccoo ncrrnrrncrnnnnencornnnnorrnrnnonrrrrn coc nnoccrrrnnrcrcrrnn crcrnnoocnnrnnnrcrnrrnnorrrrnnnccnnoencrnrnoncrrcrrrnnrnnncorcrnnnnnorrrrrorran co ccnn conoce orrrnrnnnnoornrrnncrrrnc cnn cc nnn o vcororoooreeneoonnnnconnrnncnrcrnnrorcrrnncnnnnecnnrenoncrnnncrcnnoccncnenpo nro connnnnrrrrnnoncrrnnnconnnnnrnrnnncrrnnnn cnn cer nnrrnnoncornnn connnnnnrennnornrnrncrnnn cnn nrnsnrrroncncennnnrcrnrnnnnrcrrnrnconnnncrnnnencnrnnnrrrnnrnrccnn o 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 USE OF WATER OUTSIDE THE ABOVE SPECIFICATION MAY INVALIDATE THE MACHINE WARRANTY section 12 Loading the autoclave Loading has a significant impact on how the autoclave performs section 13 Warranty UK only 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 o defective in workmanship and or materials The maximum permissi
21. rniture 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 All Customers when you receive your Alpha autoclave ensure that you complete and return your Warranty Registration Card Types of load and loading Aloha autoclaves are designed to sterilize instruments utensils and other items as defined by the European Standard EN13060 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 10 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 9 for the maximum instrument load for the autoclave All instruments must be cleaned appropriately prior to sterilizing When placing items on a tray ensure 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 from the autoclave as they may be hot Do not use an unprotected hand to hold hot trays 274454A section
22. sket wear Conduct routine maintenance procedures Replace gasket If the condition persists an engineer call out may be required POOH O SHOES HO HEEHHEHOEHHEHOEHHEEOOEEEHOGESEESSSOSEHESEEHEEH OSS OSSHHESSSEHHEHOEHHESOSESESHSEHHHSTHSEESESESHOESESSESSESHEHESEHHEES HEHEHE nc cnc nnnnesnnncrrn cananea nana cnncesssnccnnnecr o eeorrrrnS or eessoncrrnrrccnnan carac cercana cnn cnn SHEEHESOSEHHHOHEESHEHOEHSESOSHHESOSSEHOEEOHESHHOEHHESOOEHEHOOEEEHHOHOEHOEESOEOEHOTESOHOTH HEHEHE SOHO OT SOOHOHESESOOETOSEEHEOSHOEETESOEEHESOOEEEHOOHSEHEEHSEEEEEOOESESELESESEEESENS door illuminates on display L2 Cycle start button pressed whilst door is open or door micro switch requires adjustment If door closed but door LED C not illuminated push on door to see if LED can be illuminated If door open close door and try again lf fault occurs during a cycle follow Recovery sequence 659 Power failure during a cycle or power to unit switched off prior to cycle completion 659 Recovery sequence Check power supply repeat the cycle OOOO ICO nc OOOO CC OOOO a Sterilizing Temperature out of range Contamination of Sensors Contamination or wear of the gasket 653 l Recovery sequence Clean gasket and chamber face then repeat the cycle If fault persists engineer call out may be required esocooocoocococosococosoccoocoococooosocoococccosoccocccocococosoccocococoscococcoococoocococosocococsccocococococcoseco
23. tems have been replaced or cleaned as appropriate and that the water quality is as described in Section 13 before contacting Prestige Medical Ltd 274454A 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 lp 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 fe
24. ult 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 10 minutes power will automatically be restored and the display will show Error 01 The load will need to be re processed le start the cycle again Storage When leaving the unit standing idle for any length of time switch mains off 4 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 450mls per cycle typical Maximum power used 22litre 2 2kwh LEQ sound level 60db 274454A 14 section 10 Cycle profiles The profile below is for the cycles 121 C and 134 C Temperature Pressure Cycle Identificatio
25. ut 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 prior 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 trays 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
26. utine 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 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 the display UOD1 indicates that the unit may have been contaminated and could fail to operate correctly Exterior surfaces as required Exterior surfaces should be cleaned with warm soapy water using a damp cloth 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 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 w
27. utoclave although care should be taken that it cannot be knocked over WARNING Waste water and steam condensing coil may be hot Care should be taken 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 tens 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 spout 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
Download Pdf Manuals
Related Search