User Manual - Dolby Medical
Contents
1. User Manual PICO VO Page 15 of 46 1 2 3 4 5 7 8 w 7 2 A J o L 1 lo g 8 BIO 1 o o o e lan fof Pa n P Qe 2 e fa a T 1 i Mains Cord Detergent Input S7 AWI Input Cold Water Overflow Pressure Port Inlet Drain 856 5 i RO Water Machine Inlet Drain Hot Water 637 50 Inlet D E g o F Requires a clearance of 20mm all round and 50mm on the rear Scale 1 5 All measurements in mm e less otherwise specified Ensure good clean res Dmesosover Bob 90105 10511 remove alll burrs 2 12 Dimensinos over 400 up to sharp edges and Dimensions over 1500 up to production marks eee NERAL LE 1 5 Clean and Burrfree Revision A State BEING_MODIFIED PROPRIETARY AND CONFIDENTIAL Name aeaynak me BE PACA ocean i MEDISAFE UK Ltd ANY REPRODUCTION New Pico Assembly IN PART OR AS A WHOLE WITHOUT THE WRITTEN PERMISSION OF A MEDISAFE UK Ltd IS PROHIBITED Medisafe UK Limited Unless otherwise specified w N A2 REVISON ECN DESCRIPTION DAT2. Method of disconnect Water Supply Connection on product Male Union cold Service connection required Acceptable pressure range Effect of reduced pressure Acceptable flow range Effect of reduced flow Volume used per stage Acceptable temp range Depends on quality of water Depends on type of cycle Single phase 230V nominal 10 50Hz 2 4KVA max 1 x mains connection plug on 1 83m 6 feet cable 1 x mains connection plug on 1 83m 6 feet cable Remove mains plug 1 x BSP 1 x 3 4 BSP Male Union Hot Shut off valve with 74 BSP male thread positioned within 1m of product 1 3 bar 15 45 psi 2 3 bar 30 45 psi Increased filling time leading to extended total cycle time Not less than 2 litres min Increased filling time leading to extended total cycle time 5 5 litres maximum 15 25 C cold 50 60 C Hot Ref PICO EVO UM 35 09 11 Rev C Page 35 of 46 PICO CVO Section 4 3 Technical Specification User Manual Hardness Caco3 Not more than 55ppm as per External Dimensions HTMO105 refer page 65 clause 17 10 Above this value AWT will must be Front to Back 557mm 21 92 used during the cycle 856mm 33 70 with door open Width 637mm 25 07 Drain Height 477mm 18 77 Connection on product 2 x 18mm outside dia unthireaced nose tall Carton Dimensions 640 mm w Service connection required 540 mm d 480 mm h 2 x
3. PICO CVO User Manual _ Medisafe International Twyford Road Bis Ese 461641 F 44 0 1279 461643 www medi _ I z Table of Contents User Manual Section Title Page 1 Introduction 4 1 1 Memorandum of Registration 5 1 2 Important Safety Symbols and Explanation 6 1 3 Important Safety Information 7 1 4 Chemical Safety Information 8 1 5 Trained Personnel 9 1 6 Introduction 10 2 Installation 12 2 1 Unpacking 13 2 2 Installation Requirements 14 2 3 Installation 16 2 4 Connecting to a Data Logging System 18 3 Operation 19 3 1 Identify Controls 20 3 2 Changing Language 21 3 3 Changing Time amp Date 22 3 4 Changing Wash Programmes 23 3 5 Important Information on Loading 24 3 6 Operating Instructions 25 3 7 Routine Checks 27 3 8 Purging AWT After Replacement 29 Ref PICO EVO UM 2 09 11 Rev C Page 2 of 46 PICO evo Table of Contents User Manual Section Title Page 3 9 Purging Chemical After Replacement 30 3 10 Manual Door Release 31 4 Technical 32 4 1 Operating Process 33 4 2 Fault Finding Guide 34 4 3 Technical Specification 35 4 4 Warranty 37 4 5 Service Record 39 4 6 Decontamination Guide 40 4 7 Decontamination Certificate 41 Appendix EMC amp Electromagnetic compatibility Data 42 Ref PICO EVO UM 3 09 11 Rev C Page 3 of 46 PICO evo AMANFI E PICO CVO Section 1 Introduction i F Section 1 1 Memorandum of Registration User Manu
4. Important Note The PICO VO washer disinfector must earthed Chemical Safety Note 2 Connect the mains plug into the switched out Before handling of any chemical please read let and switch on This product must be con Chemical Safety Information on page 7 nected to a suitable mains power supply to enable the loading door to be released 7 3 Open door and remove any protective packaging and loose items from inside the wash chamber 4 Close door switch mains off at power outlet RS232 Data lead connection for Printer amp Medi Logger Detergent AWT There are two quick release ports provided on rear of chassis and are labelled as Detergent and AWT Remove cap from 3E Zyme deter gent bottle and place filter on end of pick up tube into bottle RO Water Supply Hot Water Supply Cold Water Supply Mains Drain Overflow Ref PICO EVO UM 16 09 11 Rev C Page 16 of 46 PICO CVO Section 2 3 Installation User Manual 10 11 12 13 14 Fit connector on other end of pick up tube to quick release port labelled as Deter gent Similarly remove the cap from AWT bot tle and place inlet tube with cap on the bottle Fit connector on other end of pick up tube to quick release port labelled as AWT Plug the mains plug into a suitable switched outlet and switch on After installing new detergent amp AWT it is important to purge detergent and AWT before u
5. FECTANT CLEANER Important safety information All safety precautions recommended for the cleaning product used must be adhered to In all cases the wearing of PPE including gloves and eye shields are strongly recommended Cleaning decontamination general instructions Apply the chosen chemical onto a clean cloth or paper towel and wipe over the surfaces as mentioned below Rinse off with tap water on a cloth or paper tow el and dry For machines with a tank assembly such as The tank must be filled with clean water containing a 5 solution of household bleach Sodium Hypochlorite and then rinsed with clean water The internal area that is not immersed including the underside of the lid must also be disinfect ed All units must be drained down thoroughly prior to return Note By the nature of its operation this washer disinfector has a tank or chamber area that is immersed in water during all phases of the cleaning disinfection cycle Therefore the main tank chamber should be clean and disinfected at the end of the cycle All that is required then is to clean and disinfect the outside surfaces and around the sides of the door and door seals hinges as the normal wash process will not clean them If however due to the nature of any fault present the unit cannot be run prior to return the tank chamber must be cleaned and decontaminated by hand following the process outlined in the notes above
6. both your warranty and your guarantee of performance Door Release For your protection the loading door is fitted with an electric safety locking system and can not be operated unless the product is connected to a mains power supply An override facility exists which allows the door to be opened manually in an emergency or if power to the product becomes interrupted A special key is provided for this purpose Installation and Maintenance This product has been factory tested to ensure that it performs according to its design parameters It is essential that the correct installation procedure is adhered to and that the recommended regular maintenance checks are performed to ensure that it continues to operate within design parameters Ref PICO EVO UM 7 09 11 Rev C Page 7 of 46 PICO CVO Section 1 4 Chemical Safety Information User Manual User must read this message prior to any chemical handling Chemical Safety Note e An emergency guideline wall chart of the chemical used in machine must be displayed near the ma chine e Do not use or handle any chemical until you have read and understood the label and the Material Safety Data Sheet MSDS for that chemical e Incase of any body contact with chemical always follow emergency procedure given in that particu lar chemical s MSDS or call emergency services e Use plastic gloves when handling any chemical e Goggles or full face visor to be worn when wo
7. concrete or ceramic discharge 8 kV air 8 kV air tile If floors are covered with synthetic ESD material the relative humidity should be at EC61000 4 2 Electrical fast 2 kV for power 2 kV for power Mains power quality should be that of a transient supply lines supply lines typical commercial or hospital environment burst 1 kV for input input output 1EC61000 4 4 output lines line tests not applicable Surge 1 kV line s to 1 kV differential Mains power quality should be that of a line s mode typical commercial or hospital environment 1EC61000 4 5 2 kV line s to earth 2 kV common mode Voltage lt 5 UT lt 5 UT Mains power quality should be that of a dips short gt 95 dip in UT gt 95 dip in UT typical commercial or hospital environment interruptions For 0 5 cycle For 0 5 cycle If the user of the PICO VO requires and voltage continued operation during power mains variations on 40 UT 40 UT interruptions it is recommended that power supply 60 dip in UT 60 dip in UT the PICO VO be powered from an input lines for 5 cycles for 5 cycles uninterruptable power supply or a battery EC61000 4 70 UT 70 UT 11 30 dip in UT 30 dip in UT for 25 cycles for 25 cycles lt 5 UT lt 5 UT gt 95 dip in UT gt 95 dip in UT For5s 0 55 Power 3 A m 3 A m If incorrect operation occurs it may be frequency necessary to position the PICO EVO further 50Hz fro
8. important note above Your PICOEVO has been despatched with a range of accessories to enable easy installa tion and efficient operation Their use is de tailed throughout this manual Ensure that all these items are present before attempting to install or operate the unit Complete the fol lowing Enclosures Check List and notify your supplier of any shortages or damaged compo nents as soon as possible Enclosures Check List e 1 Gray drain hose e 1 Blue cold water hose e 1 Red Hot Water hose e 1 Carrier system with divider e 1 Tray c w Manifold e 1 Instrument Trays e 1 Rack System e 1 Dental Burr Basket e 1 RS232 data printer lead e 1 Door Release Probe e 1 Owner s Manual e 1 Bottle 3E Zyme detergent e 1 Bottle AWT Fluid e 1 Chemical pick up tube e 1 AWT de scaler pick up tube e Routine Check Log Book UK Only Printer Printer and Medi Logger is not supplied but may be purchased as an approved accessory from your supplier using the following code Printer amp Power supply MED1014 Thermal paper rolls MED1014 1 Medi logger M20070G Detergents and Water Treatment Fluid Packs of approved detergent and bottles of water treatment fluid may be purchased from your supplier using the following codes 3E Zyme MED8035 1 x 4 Litre bottle AWT Fluid MED1000 09 4 x 0 5 Litre bottles Important Note Using non approved chemicals accessories and replacement parts may cause damage to this product an
9. 31 of 46 PICO evo AMANFI E PICO CVO Section 4 Technical Section 4 1 Operating Process User Manual Overview The PICO EVO Washer Disinfector uses a microprocessor controlled operating sequence to alternately spray accurately measured amounts of temperature controlled water from a rotating spray bar onto items loaded into purposely designed baskets and containers water is also pumped through dental handpieces connected to a mani fold A specially formulated detergent is added to the water to clean away fat protein starch body fluid residue etc A small quantity of scale inhibi tor prevents the formation of deposits on both the items being cleaned and the component parts of the washer itself The filling starts with Cold water entering the wash chamber from the mains water supply via an elec tronically controlled valve until a level sensor in terrupts and cuts off the incoming water If a fail ure should occur in the level sensor then a second independent sensor will react to cut off the water supply and prevent overflowing Once the wash chamber is filled the pre wash stage begins to remove larger deposits from the load A pump circulates water from a sump and up through a rotating spray bar in the base of the wash chamber To perform flushing and irriga tion the water is cycled alternately between the rotating spray arm and a docking port which con nects via a manifold to the b
10. ACT Automatic Control Test See Routine Checks in Section 3 7 for more information Changing Programmes To change programmes follow this procedure 1 Ensure that the following screen is displayed and then open loading door by pressing the DOOR RELEASE button Once door is open press and hold DOOR RELEASE button Use the START button to scroll through the time and date settings until the following programme prompt is displayed Holding down the START button will cause display to scroll through programmes 1 to 4 Release when the required programme is displayed Press DOOR RELEASE button once to save changes and exit menu Important Note Once selected a programme becomes the default until the procedure is repeated and an alternative selection is made pil Pall P2 P3 P4 Intensive Express Medi PH Safe 3E Zyme Medi PH Safe No of Pre Wash 002 000 001 001 001 Pre Wash duration 3 mins Omins 3 mins 3 mins 3 mins Main Wash duration 10 mins 5 mins 5 mins 5 mins 5 mins Main Wash temperature 52 C 42 C 53 C 43 45 C 53 C No of Rinses 003 002 002 002 002 Rinse duration 10010 1 mins 1 mins 1mins 1 mins Disinfection duration 10 mins 1 mins 10 mins 10 mins 10 mins Disinfection temperature 82 C 90 C 80 85 C 80 85 C 80 85 C Drying 25 mins 10 mins 20 mins 20 mins 20 mins Drying temperature 82 C 70 82 C 82 C 82 C 82 C Ref PLCO E
11. PICO CVO Section 3 6 Operating Instructions User Manual The Wash and Disinfection cycle will now commence and proceed automatically as detailed in Operating Process When the cycle is complete the door will automatically unlock and the following message will be displayed The following message sequence will now be displayed and repeated Important Notes The START button must be pressed after the cycle has finished and when the door is still open This is to acknowledge that the instruments have been unloaded If the door is closed before pressing the START button further cycles will be prevented If the door is closed before the START but ton is depressed then re open door and press START WARNING Risk of burning At the end of cycle internal surfaces of the machine may be hot up to 85 C All internal and external high temper ature surfaces including instrument basket and inner door must be allowed to cool down before unloading the load Pausing a Wash Cycle To pause operation at any time during the wash and disinfect cycle press amp hold the START button To resume operation after pausing press the START button once Aborting a Wash Cycle To abort a wash and disinfect cycle press the START button once and then the DOOR RELEASE button The program will automatically go to drain the cycle will be aborted and the following message will be displayed WARNING Risk of b
12. Position Below the drain outlet of the machine Capacity gt 20 I minute PRINTER SHELF Dimensions Suitable provision 230mm wide x 280mm deep should be made for locating the Thermal Printer Power supply connection for printer should be situated near the printer shelf Position Above or to right of the machine and within 1 meter from the machine CHEMICAL SHELF Dimensions Suitable provision for detergent amp AWT 270mm wide x 230mm deep should be made Position Detergent amp AWT must be kept at machine level If mains water pressure is lower than 1bar a pressure booster pump must be installed and if water pressure is higher than 3bar than a pressure reducing valve must be installed Please see part numbers and prices below Part Number Description Price excluding VAT MED8931 Pressure booster pump Assembly 290 00 VALVE025 Pressure reducing Valve 150 00 Above this value AWT must be used during the cycle The amount of AWT depends on the hardness of the water please contact Medisafe UK Ltd service department Tel 01279858400 In case Printer and Medi Loggers are connected to same machine an extra 13A mains power outlet must be installed There are two drain hose connected to the machine for overflow and machine s drain Note Failure to install your PICO VO following the above guidelines could invalidate your warranty Ref PICO EVO UM 14 09 11 Rev C Page 14 of 46 PICO evo
13. The PICOE VO is intended for use in the electromagnetic environment specified below The customer or the user of the PICO VO should assure that it is used in such an environment Emission test Compliance Electromagnetic environment guidance RF emissions The PICOEVO uses RF energy only for its internal Group 1 function Therefore its RF emissions are very low CISPR 11 p and are not likely to cause any interference in nearby electronic equipment The PICOEVO is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes RF emissions CISPR 11 Class B Harmonic emissions IEC61000 3 2 oer Voltage fluctuations flicker emissions i Complies IEC61000 3 3 Ref PICO EVO UM 43 09 11 Rev C Page 43 of 46 PICO evo Appendix EMC amp Electromagnetic compatibility Data User Manual III Guidance and manufacturer s declaration electromagnetic immunity The PICOEVO is intended for use in the electromagnetic environment specified below The customer or the user of the PICOEVO should assure that it is used in such an environment Magnetic field 1EC61000 4 8 Immunity test IEC 60601 Compliance level Electromagnetic environment guidance test level Electrostatic 6 kV contact 6 kV contact Floors should be wood
14. and AWT air To purge AWT manually follow steps below will be purged through the hose for 4 to I 0 5 seconds and will stop automatically Re 1 Ensure that the following screen is dis move figure from START button _ Delors ettemipdng Eo go LESE ierant pump is ON it Shows ANTON on screen and when it stops automatically check Detergent it shows AWT OFF 9 Press START again to prime AWT again 2 Press DOOR RELEASE button once to open ana repeat this procedure uni cet 688 the door Once door 16 open press DOOR been seen coming through the water inlet diffuser The water inlet diffuser location RELEASE button again for at least 5 sec ds The following screen will now be dis ONMIN e P A ea 10 Once AWT is purged press DOOR RELEASE button twice to go back to standby mode as following 3 Press START button once and following _ crear message will be displayed 4 Press START button three times and cursor will move from hours to minutes and then display will show DATE option as below Ref PICO EVO UM 29 09 11 Rev C Page 29 of 46 PICO evo Section 3 9 Purging Chemical after replacement User Manual WARNING Before handling of any chemical please read Chemical Safety Information on page 8 After replacing the new chemical container 5 Press START button three times and cursor it is important to purge chemical through the will move from hours to minutes and then empty chemical hose to take
15. been undertaken normal operation of the PICO VO can be affected by other electrical electronic equipment and portable and mobile RF communications equipment As the PICO VO is medical equipment special precautions are needed regarding EMC electromag netic compatibility It is important that the PICO VO is configured and installed put into service in accordance with the instructions guidance provided herein and is used only in the configuration as supplied The PICOE VO s data cable must be restricted to less than 3m in length and should not be extended by the user If the PICO VO is used with adapted cables or cables other than those supplied this may result in increased emissions or decreased immunity of the PICO VO in relation to EMC per formance It should be noted that the cables provided with the PICOEVO should not be used on other equip ment To do so may result in increased emissions or decreased immunity of the other equipment in relation to EMC performance The PICO GVO should not be used adjacent to or stacked with other equipment If adjacent or stacked use with other equipment is necessary the PICOEVO and the other equipment should be observed monitored to verify normal operation in the configuration in which it will be used For the purposes of EN60601 1 2 the PICOGVO has an essential performance as follows 1 Functions within the operating cycle should continue to operate as normal the product should com
16. by an authorised Medisafe dealer or distributor or being repaired or replaced by a person who is not an authorised Medisafe dealer or distributor Ref PICO EVO UM 37 09 11 Rev C Page 37 of 46 PICOECVO Section 4 4 Warranty User Manual Damage caused by accident abuse or negligence of the proper handling as set out in this Owner s Handbook misuse of the new Washer Disinfector use of the new Washer Disinfector under unusual conditions and modifications of or to the new Washer Disinfector or any component parts thereof not recommended or approved by an authorised Medisafe dealer or distributor Damage caused by external influences such as chemical spillage accident fire and disasters due to human fault or negligence or Act of God Damage to the external casing wash chamber load carriers or any part of the new Washer Disinfector which may come into contact with the load carrier during the process of loading unloading the new Washer Disinfector All charges incidental to breakdowns such as loss of use of the new Washer Disinfector loss of time inconvenience telephone transportation loss or damage to personal property or loss of revenues or other matter not specifically included Damage caused by incorrect installation of the new Washer Disinfector which could cause operational failure or impairment either immediately after such installation or at any time within the period of this PRODUCT WARR
17. open your Hyper Terminal i e click PicoHyper go to the Capture Text menu and either enter a new file name for the data or retain the existing one in which case new data will be appended to it When you have made your choice click Start to begin receiving data when the PICOEVO is connected Washer ID 1H15526 Cycle No 00083 Cycle start P1 14 06 35 17 08 05 Draining 14 06 35 Draining 14 06 43 Ref PICO EVO UM 18 09 11 Rev C Page 18 of 46 User Manual PICO CVO AMANFI E PICO CVO Section 3 Operation Section 3 1 Identifying Controls User Manual Important Note If the equipment is used in a manner not specified by the manufacturer the protection provided by the equipment may be impaired DOOR RELEASE Press to open door Press in paused mode to abort cycle Also used to amend settings during default changes PRE WASH Cold water pre wash stage of LCD DISPLAY cycle is in progress Indicates wash disinfect information at every stage of cycle and displays any error messages WASH Main wash stage is in progress RINSE Load is being rinsed prior to disinfection stage He DI SINFECT Disinfection stage is in progress DRYING Drying stage is in progress COMPLETE Cycle is complete and load may be removed once cooled START BUTTON Press once to start or pause the wash cycle Also used to change default
18. out all blocked display will show DATE option as below air Please follow chemical safety information on page 35 To purge chemical through the test mode follow the steps below DATE 02 01 00 h Fouawimg Be MES eee 6010 06 51000 ON 6 On pressing START button three times the LOD display belore start of procedure cursor will move from date to month and at the end it will be blinking under the year 7 Press START again and Prime AWT Pump 8 Press START and Prime Det Pump will be If display shows Load Instruments then go shown as below to step no 4 If display shows Check Detergent then go bet OFF to step no 2 2 To clear this user need to switch off the 9 To purge the detergent press START to machine from the mains switch on the wall switch ON detergent pump and it will count and switch back ON This will then display the detergent quantity from 00 to 10 This Program Aborted Power Failure is shown on right hand side of the display When detergent pump is ON display shows 3 Press DOOR RELEASE button once to open Det ON and after counting up to 10 it the door Once door is open press DOOR stops automatically and shows Det OFF RELEASE button again for at least 5 sec onds The following screen will now be dis 10 Press START again to prime detergent and played repeat this procedure until detergent can be seen coming through the water inlet 0 diffuser The water inlet diffuser loca
19. plete it s operating cycle correctly wash disinfect water temperature should remain at 93 deg C 1 deg O Slight flickering of the product s LCD display is allowable as is clicking of solenoids valves during transient type tests providing the LCD display remains legible and the solenoids valves do not change state If the product is subject to electrical interference in the form of Fast Burst Transients IEC EN 61000 4 4 on the mains supply the products LCD display is likely to flicker however the display should remain legible If the product is subject to electrical interference in the form of Surges IEC EN 61000 4 5 on the mains supply the products solenoids valves may be heard to click briefly but no change in the actual status of the solenoids valves should be seen If the product is subject to dips interruptions in the AC mains supply voltage IEC EN 61000 4 11 the product s LCD display may dim for the duration of the dip interruption or the product may turn off briefly and display a power failure message Normal product operation will resume upon restora tion of the AC mains supply the user will need to clear the power failure warning if displayed In all of the above cases connecting the product to a different power outlet mains circuit may re solve these issues Ref PICO EVO UM 42 09 11 Rev C Page 42 of 46 PICO evo Appendix EMC amp Electromagnetic compatibility Data User Manual
20. settings I I MPORTANT The door cannot be released unless the product is connected to a mains power supply To manually open door please refer to Section 3 10 on page 30 Ref PICO EVO UM 20 09 11 Rev C Page 20 of 46 PICO evo Section 3 2 Changing Language User Manual Changing Language The LCD display on the front panel of the Procedure product can be programmed to display text in one of four different languages Once selected Important Note a language becomes the default setting until The time allowed to make an entry is the procedure is repeated and an alternative relatively short so prompt input is required selection is made The languages are scrolled once the sequence has been commenced in the following order 1 Disconnect product from mains supply wait 1 French a few seconds and then reconnect 2 German 3 Spanish 2 Observe the messages shown on the LCD 4 English display whilst following the procedure 5 Japanese 3 Press and hold the START button until select language prompt is displayed 4 Press and hold the START button until required language is displayed 5 Press the DOOR RELEASE button once only 6 The selected language is now stored I mportant Note If product is not fitted with a removable mains plug then consult a qualified person before attempting to disconnect power supply Ref PICO EVO UM 21 09 11 Rev C Page 21 of 46 PICO evo Section 3 3 Changing T
21. 1 2 dia drain fitted with suitable trap located below level of work surface with drainage capacity in excess of 20 litres min Maximum flow to drain 4 litres min Maximum temperature of effluent 85 C Ventilation Maximum temperature of load 85 C Chemicals Size and Nature of Containers AWT Fluid 0 5 litre plastic bottle with spout 3E Zyme 5L bottle with screw cap Storage Instructions Refer to Chemical Data Sheet provided with chemical Safe Handling Instructions Refer to Chemical Data Sheet provided with chemical Quantity Used per Cycle AWT Fluid Depends on the quality of water 3E Zyme Depends on type of cycle Weights amp Dimensions Dry weight 55kg empty Operational Weight 65kg with fluids Shipping Weight 75kg Internal Dimensions Front to Back 465mm 18 3 Width 435mm 17 12 Height 300mm 11 81 Wash Chamber Size 60 68 litres 16 03 US Gal Ref PICO EVO UM 36 09 11 Rev C Page 36 of 46 PICO V Section 4 4 Warranty User Manual Product Warranty To ensure continued efficiency and long operational life your new Washer Disinfector is covered by a 12 month or 1200 cycle whichever occurs first warranty which is arranged and administered by Medisafe UK Ltd Details of the warranty are explained in this section Subject to the following terms and conditions Medisafe UK Ltd warrants that any item of THE BASIC WARRANTY ITEMS of the unit hereinafter call
22. 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the PICO VO is used exceeds the applicable RF compliance level above the PICO VO should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orientating or relocating the PICOCGVO b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Ref PICO EVO UM 45 09 11 Rev C Page 45 of 46 PICO evo Appendix EMC amp Electromagnetic compatibility Data User Manual IV R mmen ration distan tween rtabl nd mobile RF communication equipment and the PICOeVO The PICO VO is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the PICO VO can help prevent electromagnetic interference by maintaining a minimum distance between por
23. ANTY Medisafe UK Ltd reserves the right of final decision on all manufacturers warranty claims Nothing herein affects the statutory rights of a consumer Service contracts Pay As You Go Calibration and safety test one visit Pay As You Go Plus Calibration and safety test one visit plus three emergency call outs Bronze Four visits Calibration and safety test Silver Four visits Calibration and safety test to HTM2030 Plus four emergency call outs Ref PICO EVO UM 38 09 11 Rev C Page 38 of 46 PICOECVO Section 4 5 Service Record User Manual Medisafe recommend that your PICOCVO Washer Disinfector is serviced in accordance with the schedule contained within the Service Manual at intervals of 3 months This record Note No user serviceable parts inside Service and repair should be referred to qualified persons only must be completed by the Engineer conducting i the Service and should be made available in the event of a warranty claim or breakdown repair 3 Month 6 Month 9 Month Serviced by Serviced by Serviced by Date Date Date Cycles since last Cycles since last Cycles since last service service service Next service Cycles Date Next service Cycles Date Next service Cycles Date due due due 12 Month 15 Month 18 Month Serviced by Serv
24. E Twyford Road All dimensions n milimelers D15040 Bishop s Stortford 1 2 3 4 5 6 7 8 M28 SLI 130102 z cod database MED MET FAB Davelopment SHEET 1ot1 Section 2 2 Installation Requirements Ref PICO EVO UM 15 09 11 Rev C Section 2 3 Installation User Manual Important Note Medisafe UK Ltd strongly advise that this 5 product be installed and commissioned by Me disafe or by a suitably qualified person before use Connecting the Washer Disinfector 6 1 Place the product on a sturdy level surface within 1 meter of a mains supply two supplies if the optional printer or Medi Logger has been specified suitable drain and suitable hot and cold water supply as detailed with in and remove mains plug Identify two grey plastic convoluted drain hos es attached at the back of the unit Connect these hoses to suitable mains drain sited be low the level of the drain outlet on the unit Identify the blue and Red water supply hose supplied with the unit Connect both of them with the respective cold and hot water inlet given at the lower rear of the unit Connect the other end to a suitable water supply Important Note the Installation Requirements Ensure that the black plastic washer fitted to the supply hose end is in place before tightening Mains isolation is achieved by removing the plug so ensure that the outlet is easily accessible
25. PD5304 2005 Low Voltage Directive 2006 95 EC Physical Agents Directive 89 391 EEC Supply of Work Equipment Regulations SOWER Water Supply Water Fittings Regulations 1998 EN 60601 1 2 2007 BS EN 60601 1 6 2010 EMC Directive 89 336 EEC Management of Health amp Safety at Work Regulations MHSWR Environmental conditions Indoor use Altitude up to 2000m Temperature 5 C to 40 C Maximum relative humidity 80 for temperatures up to 31 C decreasing linearly to 50 relative humidity at 40 C Mains supply voltage fluctuations up to 10 of the nom inal voltage Transient overvoltages typically present on the mains sup ply Overvoltage Category l1 Pollution Degree 2 Wash Cycle Parameters Wash temperature Nominal 42 C using 3E Zyme solution Disinfection conditions Moist heat 80 C to 85 C Disinfection period band Holding time Equilibration time Plateau period Min temp during cycle Max temp during cycle Accuracy of temp measurement 80 85 C for minimum period of 10 minutes 10 minutes Disinfection Conditions Approximately 3 minutes Approximately 5 minutes Determined by temperature of water supply 85 C lt 2 85 C Volume of dispensed chemicals AWT Fluid 3E Zyme Required Services Electricity Supply Supply type required Power consumption Termination Pico Termination Printer
26. Ref PICO EVO UM 40 09 11 Rev C Page 40 of 46 PICOECVO Section 4 7 Decontamination Certificate User Manual DECONTAMINATION CERTIFICATE ENSURE THAT ITEMS RETURNED TO YOUR SUPPLIER ARE DISINFECTED IN ACCORDANCE WITH THE APPROPRIATE HOSPITAL PROCEDURE FOR EQUIPMENT OF THIS TYPE A COPY OF THIS FORM MUST BE COMPLETED AND ATTACHED TO THE OUTSIDE OF THE CARTON WHEN RETURNING THE PRODUCT TO YOUR SUPPLIER WITHOUT THIS FORM BEING VISIBLE THE COURI ER AND OR YOUR SUPPLIER ARE AT LIBERTY TO REFUSE HANDLING OF THE PRODUCT I hereby certify that the machine referred to in this document by model number and serial number has been disinfected in accordance with Hospital Procedure Model No Serial No Hospital Name Signature Ref PICO EVO UM 41 09 11 Rev C Page 41 of 46 PICO evo Appendix EMC amp Electromagnetic compatibility Data User Manual I Special Instructions Notes regarding the PICO VO and Electromagnetic compatibility EMC testing to EN 1 1 2 2007 The PICOEVO has been tested regarding it s ability to operate in an environment containing other electrical electronic equipment including other medical devices The purpose of this testing is to ensure that the PICOEVO is not likely to adversely affect the normal operation of other such equipment and that other such equipment is not likely to adversely affect the normal operation of the PICO VO Despite the testing of the PICO VO that has
27. VO UM 23 09 11 Rev C Page 23 of 46 PICO evo Section 3 5 Important Information on Loading User Manual Important Information on Loading Instruments The capacity of maximum load on PICOEVO Benchtop Washer Disinfector is 86 Instruments with 6 dental hand pieces When loading instruments be sure to observe the following precautions Do not drop items into the chamber Do not Instruments should be load ed in such a way so that spray arms movement is not distracted Do not over load the basket Always use Dental Handpieces that are compliant with Washer Disinfector cleaning and clearly marked with the following symbol x Ref PICO EVO UM 24 09 11 Rev C Page 24 of 46 PICO CVO Section 3 6 Operating Instructions User Manual Important Note If the equipment is used in a manner not specified by the manufacturer the protection provided by the equipment may be impaired Loading the Basket Fit dental hand piece on the manifold if avail able Note that whenever dental hand pieces are placed into manifold it is important that any spare dental hand piece holder on manifold are blanked off with the caps supplied with the machine This will ensure that an effective ir rigation flow is achieved through each dental hand piece device and not by passed through the spare Luer connectors Place load into large basket and slide into the wash chamber ensuring that the basket locates correctly in docki
28. al Note to Person Installing this Product This Memorandum of Registration MUST be completed by the person undertaking installation and witnessed by the person responsible for this product Note to Owner of this Product Be sure that this Memorandum of Registration is completed by the person undertaking to install the product In the event of a Warranty Claim the information contained within this Registration is your evidence that the product has been correctly installed Important Note Failure to provide this evidence in the event of a warranty claim may result in the claim being rejected this does not affect your statutory rights as a customer Owner s Name U Installation Address Installation Date TILE LE Product type Po Auto Dosing Facility lt LIne Serial Number LTT 1111 TIL Software Version 11 I Installed by Witnessed by po Service and Maintenance Requirements This product should be serviced on a regular basis to ensure that the product continues to perform within the guidelines recommended by your local national washing disinfection Periodic Testing regime Ref PICO EVO UM 5 09 11 Rev C Page 5 of 46 PICO evo Section 1 2 Important Safety Symbols and Explanation User Manual If this symbol appears on equipment then the documentation must be con sulted in all cases where symbol 14 of table 1 caution is marked in order to find out the n
29. aning with AWT Fluid and then flush through with fresh water Check that holes in the rotating spray bar are not blocked and it is free to rotate without restriction Remove spray arm by unscrewing clockwise clean with AWT Fluid and then flush through with fresh water If dental handpiece manifold fitted Check that the dental handpiece manifold Ensure that manifold seal is in good condition Check door operation Ensure that loading door is free to open and close without restriction Check that rubber seal around door opening is undamaged free from any deposits Examine rubber seal around door for signs of deterioration or damage clean with a meak mixture of detergent and water Weekly Checks What to do and gt How to do it Perform Daily Checks See above Residual Protein test Perform residual protein test using Pro TEST Quick or equivalent Check dental handpiece manifold filter See section 3 12 on how to open the manifold to check and replace the filter Ref PICO EVO UM 27 09 11 Rev C Page 27 of 46 PICO CVO Section 3 7 Routine Checks User Manual Monthly Checks What to do and gt How to do it 1 Perform Weekly Checks gt See page 32 Check that all hoses are secure with no 2 Check service hose connections gt evidence of leaking Examine mains power cord for signs of 3 Check that mains pow
30. asket containing hol low instruments The pressure of the water passing through this spray bar causes it to rotate thereby assisting even distribution and a constant flow of water over and around the items to be cleaned and disinfected The pressure of water passing through the hollow instruments assists in removing deposits and residue Once the pre wash stage finished Hot water will be used from hot water supply for the main wash which includes washing Rinsing and Disinfection procedures In auto dosing system a small pump controlled by the microprocessor introduces detergent from an external container at the appropriate stage s of a wash cycle A flow sensor in line with the pump reports to the microprocessor Failure to admit the correct amount of detergent will result in an aborted cycle A filter fitted to the pick up tube is dropped into the detergent container and the other end is connected via a quick release connector mounted on the rear panel The sump situated in the base of the wash chamber contains an element which is used to heat the water to either 43 C or 53 C depending on the detergent used before a further wash commences Once complete the water is then drained and replaced with fresh Hot water to perform the first of two rinse stages Immediately prior to the sec ond rinse a small quantity of scale inhibitor AWT Fluid is automatically injected into the rinse water Water is then heated to t
31. ature of the potential hazard and any actions which have to be taken to avoid them A This symbol alertes you to situations that may cause serious body harm death or property damage Warning This symbol alerts you to situation that may cause body injury or property damage This symbol indicates the presence of electric shock hazards Dangerously high voltages are present inside the product Do not remove the outer casing Refer Warning servicing and repair to qualified personnel only IMPORTANT db This symbol indicates that I mportant Note s are manufacturer recomendation Important Note This marking indicates that this product should not be disposed with Municipal wastes throughout the EU To prevent possible harm to the environment or human health from uncontrolled waste disposal recycle it responsibly to promote the sustainable reuse of material resources In accordance with European Directive WEEE 2002 96 EC please contat your local recycling authorities for collection centers to deliver waste electrical and electronic equipment or the equipment can also be handed over to a Medisafe distributor when purchasing a new washer disinfector Ref PICO EVO UM 6 09 11 Rev C Page 6 of 46 PICOGVO Section 1 3 Important Safety Information User Manual Electrical This product operates from mains electricity and is supplied with the correct connector for the market into which it is sold If the suppli
32. cts in manufacture Solenoid valves Electric motor and pump Switches Electronic control circuits Water heating element The Specific Excluded Items THE SPECIFIC EXCLUDED ITEMS are any items of this new Washer Disinfector which are not included in THE BASIC WARRANTY ITEMS and are therefore not subject to the terms and conditions of the PRODUCT WARRANTY Expendable items which will deteriorate and require replacement with normal use of the Washer Disinfector for example rubber door seal strip lower rubber door seal Surround water inlet filter element various types of gaskets and hoses lamp bulb if fitted and other expendable parts not specifically listed Fair wear and tear of any part normal maintenance service items and the parts and any material used in connection with the new Washer Disinfector Normal deterioration or damage to plated parts paint coat and rubber parts caused by daily wear and exposure to atmosphere and environment Minor irregularities not affecting quality performance or function of the new Washer Disinfector parts thereof e g Slight noise or vibration or which appear only under particular abnormal conditions Damage caused by insufficient or improper maintenance e g Negligence of the daily weekly and monthly periodic inspections and any servicing requirements as described and specified within this manual Damage caused by using a part or lubricants not approved
33. d could result in disputed warranty claims Please read safety instructions before using any chemical on section 1 4 Ref PICO EVO UM 13 09 11 Rev C Page 13 of 46 PICO evo Section 2 2 Installation Requirements User Manual INSTALLATION m The product must be unpacked and sited on a stable and level work top capable of supporting a maximum weight of 55kgs and should be installed 50mm away from side walls and 75mm from back wall for ventilation purposes m There should be enough free space provided near the machine for safe and efficient maintenance in future WATER SUPPLY Hardness CaCO lt 55ppm as per HTM0105 refer page 65 clause 17 10 Pressure 1 3 Bar Temperature 15 25 C Cold 50 60 C Hot Connections 1 x shut off valve with 34 BSP male thread Cold 1 x shut off valve with 34 BSP male thread Hot Position of connections Within 1 meter of proposed installation ELECTRICAL SUPPLY Voltage amp Frequency 230 Vac nominal 5 50Hz Outlets 2 x 13A 3 pin outlets with total capacity of 13A Position of outlets Within 1 meter of proposed installation Method of disconnect Remove mains plugs Note In case of washing glass products i e Mirrors RO water supply lt 20 uS is recommended DRAINAGE SYSTEM Type 2 x 1 dia drains fitted with suitable traps
34. e Printer if applicable fails to operate gt Check that printer is connected to mains supply gt Check that mains supply is switched on gt Check that printer is switched on gt Check that data lead is securely plugged into sockets on Washer Disinfector and printer gt Check that printer has not run out of paper Inside of wash chamber is coated with white scale gt Check to see if AWT Fluid needs replenishing see AWT Fluid Replenishment Cycle is aborted due to low detergent level Auto Dosing variants only gt Check to see if detergent needs replenishing see 3E Zyme Replenishment Perforated sump cover in bottom of wash chamber is blocked gt Remove cover clean by immersing in AWT Fluid and then flush out Ref PICO EVO UM 34 09 11 Rev C Page 34 of 46 PICO CVO Section 4 3 Technical Specification User Manual eneral Medisafe PICO VO Range 230V 50Hz operation Product Code MED1360 Description Washer Disinfector Class Ila Type Cabinet single chamber machine type 1 Purpose To clean and disinfect surgical instruments and associated products Operating process Thermal Disinfection Applied standards HTM 2030 1997 HTM 2030 1997 HTM 01 05 2009 EN ISO 15883 1 2009 EN ISO 15883 2 2009 EN 61010 2 040 2005 BS EN 62366 2008 EN 61326 2006 ISO13485 2003 ISO 14971 2009 CEI IEC 878 BS5304
35. ed new Washer Disinfector manufactured by Medisafe UK Ltd shall be free from any defects in material and workmanship under normal use Any item of THE BASIC WARRANTY ITEMS covered by the limited warranty will be repaired or replaced free of charge by Medisafe UK Ltd or any distributor authorised by Medisafe UK Ltd to act as their agent hereinafter called authorised Medisafe dealer or distributor The factory set parameters are designed to provide the most efficient cleaning with disinfection using the manufacturers recommended detergents while giving the maximum reliability from the PICOCVO Any unauthorized changes to the wash parameters may affect the reliability and cleaning efficiency of the PICOC VO as such MEDISAFE reserve the right not to cover the warranty on PICOGVO s that have been modified outside the factory set parameters The Basic Warranty I tems THE BASIC WARRANTY ITEMS are any items except THE SPECIFIC EXCLUDED ITEMS of this new Washer Disinfector which are warranted by an authorised Medisafe dealer or distributor within 12 months or 1200 cycles whichever occurs first of the WARRANTY START DATE when this new Washer Disinfector is first installed by or for you the original purchaser as set forth on the Memorandum of Registration THE BASIC WARRANTY ITEMS listed below are warranted within 12 months or 1200 cycles whichever occurs first from the WARRANTY START DATE against defe
36. ed connector is removed during installation be sure to observe the correct colour code when reconnecting to an appropriate plug or fused spur Warning Dangerously high voltages are present inside the product Do not remove the outer casing Refer servicing and repair to qualified personnel only Warning To prevent fire or shock hazard do not ex pose this product to rain or moisture Heat The effective operation of this product relies on water being heated to elevated temperatures which may cause scalding if care is not taken during operation Although the automatic door locking system will assist in preventing such injuries care must be taken when loading and unloading instruments after a cycle has been completed Warning Water temperature within the wash chamber may exceed 85 C during and after operation Take care when removing items on completion of a cycle and allow good time for the items to cool to a safe temperature before handling Decontamination This product MUST be decontaminated in accordance with local regulations before trans portation In the event that the product must be returned to the supplier it is vital that the Decontamination Certificate on page 40 of this manual is completed and returned with the product Chemicals Only Medisafe detergents and additives are approved and recommended for use in this product Using non approved chemicals may cause damage to the product and could void
37. ed of with household waste Please recycle where facilities exist Check with your Local Authority or Distributor for recycling advice Manufacturer I nformation Medisafe UK Ltd The Snap Factory Twyford Road Bishop s Stortford Hertfordshire CM23 3LJ UK Telephone 44 0 1279 461641 Fax 44 0 1279 461643 E mail info medisafeinternational com Web www medisafeinternational com Ref PICO EVO UM 11 09 11 Rev C Page 11 of 46 PICOECVO AMANFI E PICO CVO Section 2 Installation e I Section 2 1 Unpacking User Manual Caution EXCESSIVE WEIGHT HAZARD To avoid back or other injury have two persons to lift the washer by using the straps as shown in the picture below Lifting Straps Carefully open the carton and with the help of two persons lift the machine by using lifting Straps to take out the machine Please note that in order to lift the machine without lifting straps the feet must be adjusted to 25mm height Please retain the carton and all pack aging materials If it needs to be returned to the supplier for any reason then the original carton and packaging materials should be re used Important Note This product must be connected to a suitable mains power supply to enable the loading door to be released Connect product to a mains power supply and open door by pressing Door Release button Remove basket and accessory pack see
38. er cord is undamaged gt damage and check that mains plug or electrical connector is properly connected Check that the docking port components located in the wash chamber and on the i gt a EMRE sn nie Large Basket are undamaged and that the basket engages without restriction 5 Check gasket between door and basket gt s A 25 Ker On MONI D os is in place 6 Cleaning Efficacy Test gt Perform test by using standard PCD kit Process Challenge Device or equivalent Ref PICO EVO UM 28 09 11 Rev C Page 28 of 46 PICO evo Section 3 8 Purging AWT After Replacement User Manual WARNING Before handling of any chemical please read Chemical Safety Information on page 8 One AWT bottle contains sufficient anti scaling 5 On pressing START button three times the fluid for up to 70 wash and disinfect cycles cursor will move from date to month and at dependent upon water hardness and default the end it will be blinking under the year settings used On completion of 50 cycles 6 Press START again and Prime AWT Pump the LCD DISPLAY will indicate that more fluid will be shown as below is required and the unit will not proceed with a new wash and disinfect cycle until you confirm that it has been added WT OFF After replacing AWT bottle it is important to purge 7 At this point press and hold START button AWT through the empty inlet hose to take all blocked This will switch ON AWT pump
39. g device or computer Ref PICO EVO UM 33 09 11 Rev C Page 33 of 46 PICO EVO Section 4 2 Fault Finding Guide User Manual The following table will enable a non technical user to diagnose basic problems and affect a cure that will enable normal operation to be resumed as soon as possible If the problem persists after performing these checks it will be necessary to contact your supplier Symptom Possible Cure Loading door will not open gt Check power cord is properly connected gt Check mains supply is switched on No read out on LCD Display and no LED illumination on front panel gt Check power cord is properly connected gt Check mains supply is switched on Unit fails to take in cold water but LCD Display indicates Filling gt Check that Hot cold water supply is connected a Check that hot cold water supply is switched gt Check that Hot cold water hose is not kinked Unit fills too slowly with cold water gt Check that filter in Hot cold water inlet valve is not blocked remove cold water hose to access filter LCD Display on unit indicates Program aborted during cycle gt Check that loading door has not been opened during cycle LCD Display on unit indicates Power failure cycle aborted gt Check that mains supply to unit has not been temporarily disconnected and then reinstated within a timescale which has compromised the cycl
40. he correct temperature ready to perform a disinfection cycle The Hot wa ter is intermittently circulated within the tank and through the hollow instruments during the heating period in order to aid thermal efficiency and to re duce the overall cycle time Once the correct temperature is reached the disinfection cycle begins The microprocessor then accurately controls the temperature of the water via two independent temperature sensors This ensures that the correct temperature is maintained for the duration of the disinfection stage Finally the circulation pump is driven in reverse to drain the wash chamber for the final time Once the wash chamber is emptied the LCD Display indicates that the cycle has been successfully completed If for any reason an error was recorded during the cycle then the washer will advise this by displaying the message cycle failed at this time In order to prevent unclean non disinfected items from being removed prematurely the loading door will remain locked until the failed cycle is acknowledged Such an interruption to the cycle will be notified with a PROGRAM ABORTED message Each cycle has a unique sequential number and contains information regarding date time temperature and duration of each stage of the cycle to afford total trace ability An RS232 Data Port at the rear of the washer allows the connection of an external printer to display the data in printed form or to a data loggin
41. iced by Serviced by Date Date Date Cycles since last Cycles since last Cycles since last service service service Next service Cycles Date Next service Cycles Date Next service Cycles Date due due due 21 Month 24 Month 27 Month Serviced by Serviced by Serviced by Date Date Date Cycles since last Cycles since last Cycles since last service service service Next service Cycles Date Next service Cycles Date Next service Cycles Date due due due 30 Month 33 Month 36 Month Serviced by Serviced by Serviced by Date Date Date Cycles since last Cycles since last Cycles since last service service service Next service Cycles Date Next service Cycles Date Next service Cycles Date due due due Ref PICO EVO UM 39 09 11 Rev C Page 39 of 46 PICO EVO Section 4 6 Decontamination Guide User Manual All medical washers should be cleaned weekly as part of the routine maintenance for operator s Health and Safety for the purposes of routine maintenance PRIOR to the arrival of the engi neer and for transportation By decontamination we refer to the unit being cleaned and disinfected Machines returned in an un cleaned state WILL incur additional charges for cleaning and decon tamination For the internal or external surfaces a disinfectant cleaner e g Medisafe DISS ALL Product code MED8051 or any household kitchen cleaner can be used providing it is marked as a DISIN
42. ime amp Date User Manual Procedure 1 Ensure that the following screen is displayed 8 Momentarily press START button before attempting to adjust programme date or time settings 9 The following screen will now be displayed with a prompt flashing before the DAY segment of the display Press and hold the START button until the correct DAY is 2 Press and hold DOOR RELEASE button for displayed at least 2 seconds The following screen will now be displayed Holding the START button will cause the display to scroll through programmes 1 to 10 Momentarily press the START button 4 See Changing Programmes in Section 3 4 for details on setting the correct 11 The following screen will now be displayed programme with a prompt flashing between the DAY and MONTH segments of the display Press and hold the START button until the correct MONTH is displayed 3 After a few seconds the following screen will be displayed with a prompt flashing before the HOUR segment of the display Press and hold the START button until the 12 Momentarily press the START button correct HOUR is displayed 13 The following screen will now be displayed with a prompt flashing between the MONTH and YEAR segments of the display Press 4 Momentarily press the START button and hold the START button until the correct YEAR is displayed 5 The following screen will now be displayed with a prompt flashing between the HOUR eel and MINUTES seg
43. l decontamination standards Drying Drying is achieved by forced hot air circula tion within the chamber to remove residual moisture from the instruments and hand piece channels leaving the instrument load dry and ready for the sterilisation process Scale I nhibitor To improve cleaning performance and to help reduce scaling during thermal disinfection a de scaling additive AWT Fluid is automatically introduced into the cycle This helps to ensure that the unit maintains optimum performance throughout its operational life Ref PICO EVO UM 10 09 11 Rev C Page 10 of 46 PICO CVO Section 1 6 Introduction User Manual Compliance All variants in the PICO VO range have been designed to perform within the guidelines recommended by international decontamination Standards A stringent quality control programme ensures that every unit is manufactured and tested under controlled conditions to ensure that all products perform identically Declaration of CE Conformity The PICOECVO range is designed and manufactured in the UK by Medisafe UK Ltd and complies with the essential requirements of the Medical Devices Directive 93 42 EEC where appropriate All products are CE compliant and are registered as Class Ila devices through the application of all 18 rules within Annex IX of the Medical Devices Directive 93 42 EEC 0473 Environmental Policy Waste electrical and electronic products must not be dispos
44. lti pin plug on the other end of the RS232 Data Lead to the COM1 or COM2 port on the PC 3 Locate the Hyper Terminal program in Pro grams Accessories Communications Hy perTerminal and click Hyper Terminal 4 Enter name e g PicoHyper and select an icon from those provided Click Ok 5 By default COM1 is selected as the communications port Click Ok 6 The name of the Hyper Terminal bar has changed to PicoHyper Hyper Terminal and you now have your own Hyper Terminal From the File menu select Properties gt gt Settings gt gt Terminal Keys CtrI H is selected Emulation is set to Auto Detect Terminal ID is set to ANSI Buffer is set to 500 Tick append line feeds to receiving ends Tick wrap lines that exceed terminal width Click Ok to accept port initialization From the Transfer menu select Capture Text The incoming data needs to be stored in a file so enter the name of a directory and filename e g C PicoHyper DataLog txt or browse around and find a suitable folder before adding the name of the file you want to save the data in Click Start The PicoHyper Hyper Terminal is now ready and if linked to a PICOE VO will be receiv ing data 10 When the PicoHyper is closed all received data will be saved in the DataLog file Next time you use the Hyper Terminal use the File menu and select Open When you choose to
45. m sources of power frequency magnetic fields or to install magnetic shielding The power frequency magnetic field should be measured in the intended installation location to assure that it is sufficiently low NOTE UT is the a c mains voltage prior to application of the test level Ref PICO EVO UM 44 09 11 Rev C Page 44 of 46 PICO CVO Appendix EMC amp Electromagnetic compatibility Data User Manual Immunity test IEC 60601 Compliance Electromagnetic environment guidance test level level Portable and mobile RF communications equipment should be used no closer to any part of the PICOEVO including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d Conducted RF 3 Vrms 3V d 1 2VP 1EC61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m 3 V m d 1 2VP 80 MHz to 800 MHz 1EC61000 4 3 80 MHz to 2 5 GHz d 2 3VP 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Fields strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Q NOTE 1 At 80 MHz and
46. ments of the display Press and hold the START button until the 14 Momentarily press the DOOR RELEASE correct MINUTES are displayed button once to save changes and exit menu or press START to return to step 2 above 6 Momentarily press the START button 7 The following screen will now be displayed with a prompt flashing after the SECONDS segments of the display Press and hold the START button until the correct SECONDS are displayed Ref PICO EVO UM 22 09 11 Rev C Page 22 of 46 PICO GVO Section 3 4 Changing Wash Programmes User Manual Washing is achieved using unique specially formulated and clinically validated detergents which are introduced during the operating cycle to clean away fats proteins starches body fluid residues etc Two types of detergent may be used a liquid enzymic detergent 3E Zyme or a liquid alkaline detergent Both types of detergent are drawn into the wash chamber via a flexible hose from a container located adjacent to the unit Important Note The PICO VO MUST be reprogrammed each time the detergent type is changed The following tables indicate the target parameters for each of the programmes which must be met to ensure compliance with International Standards The accuracy of these parameters may be monitored by observing a print out from the Thermal Printer if sup plied or by viewing the Front Panel LCD as a cycle progresses This should be done every day as part of your
47. ng port in rear of wash chamber Note that water is sprayed up from the bottom of the chamber so large items such as trays and bowls should NOT be placed flat on the bottom of the large basket as this will obstruct the water spray Important Note Do not overload the large basket so that water spray is obstructed Commencing a Cycle 1 Apply power to the product and press the DOOR RELEASE button to open the door Warning Ensure that the filter on the pick up tube is immersed in detergent before commencing a wash cycle Failure to do so will result in an aborted cycle if sufficient detergent is not available To replenish an empty detergent container remove filter on pick up tube from bottle and place into full container 2 Close the door 3 Observe the messages shown on the LCD display and follow this procedure 4 If this message is displayed then refer to AWT Replenishment 5 Press START button once If AWT Fluid has already been added then continue If not then refer to AWT Fluid Replenishment in Section 3 8 The descaler messages will only be shown at very first power up or when AWT Fluid is low 6 Press START button once 7 When the following message is displayed load instruments Press START button once 9 When the following message is displayed ensure that all instruments are correctly loaded and press START button once Ref PICO EVO UM 25 09 11 Rev C Page 25 of 46
48. rking with detergent or chemicals e Itis recommended to wear a plastic disposable apron e Use funnel whenever transferring any chemical from one container to another e Always follow MSDS instructions for safe disposal of chemical container Ref PICO EVO UM 8 09 11 Rev C Page 8 of 46 PICO evo Section 1 5 Trained Personnel User Manual The owner of this equipment has the responsibility for giving training and keeping records of training to the user The following table can be used for keeping training records Date Name Signature Ref PICO EVO UM 9 09 11 Rev C Page 9 of 46 PICO GVO Section 1 6 Introduction User Manual The PICO VO Washer Disinfector The PICOCVO range of washer disinfectors have been designed to clean various surgi cal instruments implements and associated products used within a medical environment This objective is achieved through separate wash and disinfection stages of an automatic cycle Optimum decontamination is ensured though the use of sophisticated electronics which control and monitor the entire cycle without any need for user input If a wash disinfect cycle fails to achieve any one of the predetermined parameters then the system reports a failed cycle The unit registers such a failure and brings it to the attention of the operator who is then unable to remove the load without being aware that the cycle has been abor
49. sing the machine The guidelines to purge detergent and AWT are given on page 34 and 35 respectively Turn ON the water supply and check for any leaks Your PICOCVO Washer Disinfector is now ready to use Connecting the Printer If supplied 1 Identify the RS232 Data Lead supplied with the PICO VO Connect the 3 5mm jack plug to the data port on the lower rear pan el of the PICOGVO unit Connect the multi pin plug on the other end of the RS232 Data Lead to the connector on the rear of the printer RS232 Data Lead Power Lead Identify the plug top power supply packed with the printer Connect to socket on rear of printer and plug into a suitable mains supply outlet and switch ON Turn the Printer ON using the switch located on the left hand side Ref PICO EVO UM 17 09 11 Rev C Page 17 of 46 PICOECVO Section 2 4 Connecting to a Data Logging PC Connecting to a Data Logging PC The PICO VO transmits data of a wash cy cle from the serial port at a speed 2400 bits per second 8 data bits no parity 1 start bit 1 stop bit no handshaking As an alterna tive to a printer this data may be sent to a logging device or to a computer via the se rial port COM1 or COM2 and Microsoft s Hyper Terminal programme 1 Identify the RS232 Data Lead see image on left supplied with the unit Connect the 3 5mm jack plug to the data port on the lower rear panel of the unit 2 Connect the mu
50. table and mobile RF communications equipment transmitters and the PICO VO as recommended below according to the maximum output power of the communications equipment Rated maximum output power Separation distance according to frequency of transmitter m of transmitter W 150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2vP d 1 2vVP d 2 3yP 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 3 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Ref PICO EVO UM 46 09 11 Rev C Page 46 of 46 PICO CVO
51. ted General Wash The PICOEVO is primarily intended to wash and disinfect general medical instruments which are placed within a range of removable baskets A rotating spray arm distributes fluid evenly over the load Lumen Wash As well as a rotating spray arm the PICOGVO adds the facility to wash and disinfect the in side of lumen devices such as dental hanpieces which are connected on high pressure hand piece manifold Auto Dosing All PICOEVO models are supported by Auto matic Dosing System which introduces a con trolled amount of detergent from an external container during the appropriate stage s of a wash cycle Washing Washing is achieved using unique specially formulated and clinically validated detergents which are introduced into the cycle during the operating cycle to clean away fat protein starch body fluid residue etc The detergent 3EZyme or Medisafe PH safe is dispensed just before the wash cycle by automatic meas ured dispensing system into the chamber from an external container Important Note It is vital that the correct programme is chosen according to the detergent being used Details can be found in Section 3 4 Disinfecting Effective thermal disinfection is achieved by raising the temperature of the final rinse water within the wash chamber to a predetermined level and then maintaining this temperature for a period of time specifically identified as being acceptable by internationa
52. tion inside the chamber is identified in the 4 Press START button once and following picture on previous page message will be displayed 11 Once detergent is purged press DOOR RELEASE button twice to go back to standby Ref PICO EVO UM 30 09 11 Rev C Page 30 of 46 PICO evo Section 3 10 Manual Door Release User Manual Procedure If the product fails to operate due to a fault with the electricity supply then the loading door will remain locked until power is restored In the unlikely event that an internal fault causes a failure the loading door can be released manually using the Door Release Probe supplied with the product If the outer cover needs to be removed by a qualified person then access to the securing screws can only be gained if the door is in the open position IMPORTANT Opening the door using this procedure will enable access to a partially cleaned load and it is therefore essential that the cycle is recommenced as soon as possible 1 Remove mains connector from supply socket or isolate power if connected directly to a fused spur 2 Unscrew anti clockwise threaded plug towards the top right hand side of the Outer Cover fig 1 3 Insert Door Release Probe into exposed hole and push firmly fig 2 4 The loading door will now be released 5 Replace threaded plug Fig 1 Unscrew threaded plug Fig 2 Insert Door Release Probe and push firmly in direction of arrow Ref PICO EVO UM 31 09 11 Rev C Page
53. urning If program is aborted at any stage of the cycle the internal surfaces of the machine may be hot up to 91 C All internal and external high temperature sur faces including instrument basket and inner door must be allowed to cool down before unloading the load Ref PICO EVO UM 26 09 11 Rev C Page 26 of 46 PICO CVO Section 3 7 Routine Checks User Manual To ensure that your PICO VO continues to operate within the design parameters and to ensure continued compliance with the guide lines identified as acceptable by international decontamination standards it is recommend ed that the following checks are performed on a regular basis Consulting the Fault Finding guide may prove useful when conducting the checks Important Please note that completion of these checks is not a substitute for regular servicing and maintenance by a suitably qualified engineer Daily Checks What to do and gt How to do it Select a recent printout if a printer is connected and compare parameters with the first printout generated after installation Verify accuracy of electronic control systems Clean with a weak mixture of detergent Check cleanliness of all external surfaces and water Check that the inside of the wash chamber is clean and free from any deposits Clean with a weak mixture of detergent and water Check that the perforated sump cover at the bottom of wash chamber is not clogged Cle
Download Pdf Manuals
Related Search