User Manual - Dolby Medical
Contents
1. DRAINAGE SYSTEM Type 2 x 1 dia drains fitted with suitable traps Position 0 300mm above the base 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 3 _ 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 invalidat2. Medisafe International Twyford Road Bishop s Stortfor 279 461641 F 44 0 1279 461643 www med safeinternation Section 1 1 Memorandum of Registration User Manual 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 Installation Address Installation Date TILE ILE Product type Po Serial Number ATT TL Software Version 00000 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 XXL UM 5 03 13 Rev A Page 5 of 48 PICO evo XXL Section 1 2 Important Safety Symbols and Explanation User Manual If this symbol appears on equipme
3. PICO CVO XXL User Manual Nessa International Twyford Road Bish 1279 461641 F 44 0 1279 461643 ww medis 31 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 PC 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 Program Parameters 24 3 6 Instructions on Instrument Selection 25 3 7 Operating Instructions 26 3 8 Routine Checks 28 Ref PICO EVO XXL UM 2 03 13 Rev A Page 2 of 48 PICOCVO XXL Table of Contents User Manual Section Title Page 3 9 Manufacturer Recommendations 30 3 10 Purging AWT After Replacement 31 3 11 Purging Chemical After Replacement 32 3 12 Manual Door Release 33 4 Technical 34 4 1 Operating Process 35 4 2 Fault Finding Guide 36 4 3 Technical Specifications 37 4 4 Warranty 39 4 5 Service Record 41 4 6 Decontamination Guide 42 4 7 Decontamination Certificate 43 Appendix I EMC amp Electromagnetic compatibility Data 44 Ref PICO EVO XXL UM 3 03 13 Rev A Page 3 of 48 PICO amp eVO XXL C N PICO CVO XXL Section 1 Introduction
4. RS232 Data Lead Power Lead 3 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 4 Turn the Printer ON using the switch lo cated on the left hand side Ref PICO EVO XXL UM 17 03 13 Rev A Page 17 of 48 PICO evo XXL Section 2 4 Connecting to a Data Logging PC Connecting to a Data Logging PC The PICO VO XXL transmits data of a wash cycle 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 multi 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
5. 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 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 d
6. This product operates from mains electricity and is supplied with the correct connector for the market into which it is sold If the supplied 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 90 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 44 of this manual is completed and returned with the product Chemicals Only Medisafe detergents a
7. 16 Once door is open the machine will go back to standby mode and will show the following message Ref PICO EVO XXL UM 26 03 13 Rev A Page 26 of 48 PICO GVO XXL Section 3 7 Operating Instructions User Manual Pausing a Wash Cycle Aborting a Wash Cycle To pause operation at any time during cycle To abort a cycle Press the Door Release press Door Release button once The cycle button twice will be paused and will show following mes sages on display The program will automatically go to drain the cycle will be aborted and the following message will be displayed To resume operation after pausing press the START button once WARNING Risk of burning If program is aborted at any stage of the cycle the internal surfaces of the machine may be hot up to 91 C All WARNING internal and external high temperature sur Risk of burning At the end of cycle internal faces including instrument basket and inner surfaces of the machine may be hot up to door must be allowed to cool down before 85 C All internal and external high temper unloading the load ature surfaces including instrument basket and inner door must be allowed to cool down before unloading the load Ref PICO EVO XXL UM 27 03 13 Rev A Page 27 of 48 PICO evo XXL Section 3 8 Routine Checks User Manual To ensure that your PICO VO XXL contin ues to operate within the design parameters and to ensure continued com
8. 530 mm w Ref PICO EVO XXL UM 38 03 13 Rev A Page 38 of 48 PICO evo XXL 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 called 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 PICO VO XXL Any unauthorized changes to the wash parameters may affect the reliability and cleaning efficiency of the PICOeVO XXL as such MEDISAFE reserve the right not to cover the warranty on PICO VO XXL s that have been modified outside the factory set parameters Th
9. Front Panel LCD as a cycle progresses This should be done every day as part of your ACT Automatic Control Test See Routine Checks in Section 3 9 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 2 Once door is open press and hold DOOR RELEASE button 3 Use the START button to scroll through the time and date settings until the following programme prompt is displayed Ref PICO EVO XXL UM 23 03 13 Rev A Page 23 of 48 PICO evo XXL Section 3 5 Program Parameters User Manual Parameter Units Program Number 1 2 3 4 5 6 Medi PH Type of detergent 3EZyme 3EZyme Medi PH Safe 3 EZyme Medi PH Safe Safe Number of Pre wash s 001 001 001 001 001 001 Pre wash time Mins 005 005 005 005 005 002 Irrigation OFF Time Secs 030 030 030 030 030 030 Irrigation ON Time Secs 015 015 015 015 015 015 Wash Time Mins 012 012 012 012 012 002 Pre wash Detergent Mils 085 085 085 085 085 085 Wash Detergent Mils 085 085 085 085 085 085 Wash Temperature C 058 058 058 058 058 058 Rinse Time Mins 001 001 001 001 001 001 Number of Rinses Cycles 002 002 002 002 002 001 Rinse AWT Mils 000 000 000 000 000 000 Disinfection AWT Mils i i a Disinfection Time Mins 001 001 001 001 001 001 Disinfection temperature C 090 090 090
10. lt 5 UT lt 5 UT Mains power quality should be that of a dips short gt 95 9o 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 XXL requires and voltage continued operation during power mains variations on 4090 UT 40 UT interruptions it is recommended that power supply 60 dip in UT 60 dip in UT the PICO VO XXL be powered from an input lines for 5 cycles for 5 cycles uninterruptable power supply or a battery IEC61000 4 70 9o UT 70 UT 11 30 dip in UT 30 dip in UT for 25 cycles for 25 cycles lt 59o UT lt 5 UT gt 95 9o dip in UT gt 95 9 dip in UT For5s For5s Power 3 A m 3 A m If incorrect operation occurs it may be freguency necessary to position the PICO EVO further 50Hz from sources of power freguency magnetic Magnetic field IEC61000 4 8 fields or to install magnetic shielding The power freguency 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 XXL UM 46 03 13 Rev A Page 46 of 48 PICO CVO XXL Appendix I EMC amp Electromagnetic compatibility Data User Manual Immunity test IEC 60601 Compliance Electromagnetic environment Guidance test level level Portable and mobile RF communications e
11. 090 090 090 Drying Time Mins 012 012 012 012 012 012 Ref PICO EVO XXL UM 24 03 13 Rev A Page 24 of 48 PICO evo XXL Section 3 6 Instructions On Instrument Selection User Manual Important Information on Selecting Instruments for PICO VO XXL e Always consult instrument s manufacturer for compatibility of instruments that can be washed in a washer disinfector e Aluminium steriliser trays must never be used in a washer disinfector e Chromium plated copper or brass instruments should only be processed in a washer disin fector if the plating is of high quality electroplating and the plating is undamaged e Low nickel chromium stainless steels ferromagnetic cutlery grades are not suitable use in a washer disinfector e Instruments made of different metals should not be washed together in same wash cycle in a washer disinfector e Always use Dental Hand pieces that are compliant with Washer Disinfector cleaning and clearly marked with the following symbol IX Ref PICO EVO XXL UM 25 03 13 Rev A Page 25 of 48 PICO evo XXL Section 3 7 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 Powering up the PICO EVO 1 Power up the PICO EVO and make sure that message appears on the display 2 If machine is powered up for the first time or AWT fluid is low then a
12. EVO XXL UM 20 03 13 Rev A Section 3 2 Changing Language User Manual Changing Language The LCD display on the front panel of the product can be programmed to display text in one of four different languages Once selected a language becomes the default setting until the procedure is repeated and an alternative selection is made The languages are scrolled in the following order English Danish French German Japanese Spanish Swedish AD HU ae Procedure Important Note The time allowed to make an entry is relatively short so prompt input is reguired once the seguence has been commenced 1 Switch OFF the machine from mains sup ply and wait for a few seconds 2 Switch ON the machine while press and hold the START button and wait until select language prompt is displayed as below 3 Release START button when Select Lan guage message is displayed 4 Press and hold the START button again un til reguired language is displayed 5 Press the DOOR RELEASE button once only 6 The selected language is now stored Important Note If product is not fitted with a removable mains plug then consult a gualified person before attempting to disconnect power supply Ref PICO EVO XXL UM 21 03 13 Rev A Page 21 of 48 PICO evo XXL Section 3 3 Changing Time amp Date User Manual Procedure 8 9 Ensure that the door is open and following screen is displayed before attempting to adjust progr
13. is free to open and close without restriction is undamaged free from any deposits Check that rubber seal around door opening 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 1 Perform Daily Checks gt See above 2 Residual Protein test Perform residual protein test using Pro TEST Quick or equivalent 3 Check dental handpiece manifold filter If handpiece installed the filter must be replaced after every 15 cycles Please see section 3 14 Ref PICO EVO XXL UM 28 03 13 Rev A Page 28 of 48 PICO GVO XXL Section 3 8 Routine Checks User Manual Monthly Checks What to do and gt How to do it 1 Perform Weekly Checks gt See page 29 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 power 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 Uu Large Basket are undamaged and that the basket engages without restriction heck th k front ed f basket 5 Check gasket between door and basket gt eee FC is in place i PCD kit 6 Cleaning Effi
14. 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 XXL UM 48 03 13 Rev A Page 48 of 48 PICO CVO XXL
15. or computer Ref PICO EVO XXL UM 35 03 13 Rev A Page 35 of 48 PICO GVO XXL Section 4 2 Fault Finding Guide User Manual The following table will enable a nontechnical 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 or Medisafe Service Department on 01279858400 General Problems Symptom Possible Cure Loading door will not open Check power cord is properly connected Check mains supply is switched on No read out on LCD Display and no LED illumination on front panel Check power cord is properly connected Check mains supply is switched on Printer if applicable fails to operate Check that printer is connected to mains supply Check that mains supply is switched on Check that printer is switched on Check that data lead is securely plugged into sockets on Washer Disinfector and printer Check that printer has not run out of paper Inside of wash chamber is coated with Check to see if AWT Fluid needs replenishing in section 3 11 white scale Error Codes Error Error Type Cause Possible Cure nM Check that mains supply to unit has not been 01 Power Failure PRY temporarily disconnected and then reinstated within without ending the cycle a timescale
16. which has compromised the cycle 02 Overflowing Error Overflow sensor activated gt Call Engineer 03 Draining Error Draining time is too long gt Check if mains drain is not blocked or call engineer 04 Temperature Error Temperature probes fault gt Call Engineer Check that Hot cold RO water supply is connected 05 Water Fill Error Filling time is too long Check that hot cold RO water supply is switched ON Check that Hot cold RO water hose is not kinked Duri Check that loading door has not been opened 06 Door Opened WU NU Goer P switch s activated during cycle 09 WLS Error Water level sensors fault Call Engineer 11 Heating Error Heating Element Failure gt Call Engineer 12 Water Temperature for Prewash is too high The pre wash temperature is 45C or more than 45C Check cold water supply temperature and run cycle again or Call engineer 13 Detergent Error Failed to dispense required amount of detergent in three attempts Check detergent in container or purge chemical by using instructions in section 3 12 14 Wash Temp Too Water Temperature for Check that HOT mains water temperature is high Main wash is too high not more than 60C or call engineer Wash Temp Main wash temperature Check that HOT mains water temperature is 15 exceeds the limit exceeds not more than 60C or call engineer Ref PICO EVO XXL UM 36 03 13 Rev A Page 36 of 48 PI
17. 083 Cycle start P1 14 06 35 17 08 05 Draining 14 06 35 Draining 14 06 43 Ref PICO EVO XXL UM 18 03 13 Rev A Page 18 of 48 User Manual PICO GVO XXL a PICO CVO XXL Section 3 Operation User Manual Section 3 1 Identifying Controls Important Note If the equipment is used in a manner not specified by the manufacturer the protection provided by the equipment may be impaired LCD DISPLAY START BUTTON Indicates wash Press once to start or disinfect information pause the wash cycle at every stage of cycle Also used to change and displays any error default settings messages DOOR RELASE Press to open door Press in paused mode to abort cycle Also used to amend settings during default changes PRE WASH DRYING COMPLETE POWER DOOR OPEN START STOP I m wv ABORT 0 0023 2240 po ouleJ og Aeul peol pue 33 04402 si al2 ID 31370 02 ss JBoid ul si 26635 Hulq SNIAz IG ss 1Boid ul si 20635 uono94uisig A933NISIG PICO eVOXXL wcsher Disinfector HOLIMS YAMOd 36635 uonp jJulisip 0 10110 pesulJ Bulag s peog JISNIY SSseJ6oJd ul s 20615 ysem uleW HSVM SSseJ6oJd ul si 3 2 Jo abe s ySem aid JeleN ploD HSVM 3 ud IMPORTANT The door cannot be released unless the product is connected to a mains power supply To open the door manually please refer to Section 3 13 on page 34 PICO CVO XXL Page 20 of 48 Ref PICO
18. CO CVO XXL Section 4 3 Technical Specifications User Manual eneral Medisafe PICO GVO XXL Range 230V 50Hz operation Product Code MED1330 Description Washer Disinfector Class Ila Disinfection period band 90 C Type Cabinet single chamber machine Holding time 2 minutes Disinfection type 1 Conditions Purpose To clean and disinfect surgical Equilibration time Approximately 3 minutes instruments and associated products ym Plateau period Approximately 5 minutes Operating process Thermal Disinfection Min temp during cycle Determined by temperature of Applied standards water supply Max temp during cycle 90 C HTM 2030 1997 BS EN 62366 2008 HTM 2030 1997 EN 61326 2006 HTM 01 05 2009 ISO13485 2003 EN ISO 15883 1 2009 ISO 14971 2009 EN ISO 15883 2 2009 CEI IEC 878 EN 61010 2 040 2005 BS5304 PD5304 2005 EN 60601 1 2 2007 Low Voltage Directive 2006 95 EC BS EN 60601 1 6 2010 Physical Agents Directive 89 391 EEC EMC Directive 89 336 EEC Supply of Work Equipment Regulations SOWER Management of Health amp Safety at Work Regulations MHSWR Water Supply Water Fittings Regulations 1998 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 humidit
19. Descaler Mes sage will be shown as below 3 Press START to acknowledge and following message will be shown 4 Check if AWT descaler container is con nected with sufficient fluid to run the cycle and press START again 5 Machine will go into the standby mode and is ready to operate Important Note On Load Descaler warning the fluid level must be checked in AWT container If new AWT container is being replaced or AWT is connect ed first time to the machine then AWT fluid must be purged manually Please see section 3 11 on page 32 Loading Instruments 6 Press door open button to open the door 7 Take out the carrier to load instruments and instrument cassettes 8 Fit dental hand pieces on the manifold if available 9 Load carrier on the PICO EVO and perform pre cycle checks before commencing a cycle Commencing a Cycle 10 After Pre Cycle Check close the door 11 Press START button if following message is shown 12 A second message will be displayed as be low 13 Press START again The Wash and Disin fection with drying cycle will now com mence and proceed automatically as detailed in Operating Process When the cycle is completed the Cycle Complete message will appear on display as below 14 Press START to acknowledge and series of messages will be shown on display as below 15 To unload the instruments open the door by pressing Door Release button
20. PICO evo XXL PICO CVO XXL Section 4 Technical Section 4 1 Operating Process User Manual Overview The PICO VO XXL Washer Disinfector uses a microprocessor controlled operating seguence 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 hand pieces 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 basket co
21. YEAR is displayed 14 Momentarily press the DOOR RELEASE button once to save changes and exit menu or press START to return to step 2 above Ref PICO EVO XXL UM 22 03 13 Rev A Page 22 of 48 PICO CVO XXL Section 3 4 Changing Wash Programmes User Manual Washing is achieved using unique specially 4 Holding down the START button will cause formulated and clinically validated detergents display to scroll through programmes 1 to 6 which are introduced during the operating Release when the required programme is cycle to clean away fats proteins starches displayed body fluid residues etc Two types of detergent may be used a liquid enzymic detergent 5 Press DOOR RELEASE button once to save 3E Zyme or Medi PH Safe detergent Both changes and exit menu types of detergent are drawn into the wash chamber via a flexible hose from a container located adjacent to the unit Important Note Once selected a programme becomes the Important Note default until the procedure is repeated and The PICO VO XXL MUST be reprogrammed an alternative selection is made and validated each time the detergent type is changed The program parameters table on page 24 section 3 5 indicate the target parameters for each of the programmes which must be met to ensure compliance with the Standards The accuracy of these parameters may be monitored by observing a print out from the Thermal Printer if supplied or by viewing the
22. al status of the solenoids valves should be seen 5 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 6 In all of the above cases connecting the product to a different power outlet mains circuit may re solve these issues Ref PICO EVO XXL UM 44 03 13 Rev A Page 44 of 48 PICO evo XXL Appendix I EMC amp Electromagnetic compatibility Data User Manual II Guidance and manufacturer s declaration electromagnetic emissions The PICO VO XXL is intended for use in the electromagnetic environment specified below The customer or the user of the PICO VO XXL should assure that it is used in such an environment IEC61000 3 3 Emission test Compliance Electromagnetic environment Guidance RF emissions The PICO VO XXL uses RF energy only for its internal Grin function Therefore its RF emissions are very low CISPR 11 p and are not likely to cause any interference in nearby electronic equipment RF emissions The PICO VO XXL is suitable for use in all establishments including domestic establishments CISPR 11 Class B and those directly connected to the public low v
23. amme date or time settings Press and hold DOOR RELEASE button for at least 6 seconds until following message is displayed Press START once and after a few seconds the following screen will be displayed with a prompt flashing before the HOUR seg ment of the display Press and hold the START button until the correct HOUR is displayed Momentarily press the START button The following screen will now be displayed with a prompt flashing between the HOUR and MINUTES segments of the display Press and hold the START button until the correct MINUTES are displayed Momentarily press the START button and 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 SEC ONDS are displayed Momentarily press START button 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 displayed 10 Momentarily press the START button and the following screen will now be displayed 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 12 Momentarily press the START button and the following screen will now be displayed with a prompt flashing between the MONTH and YEAR segments of the display Press and hold the START button until the correct
24. ar 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 working with detergent or chemicals e It is 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 XXL UM 8 03 13 Rev A Page 8 of 48 PICO evo XXL 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 XXL UM 9 03 13 Rev A Page 9 of 48 PICO evo XXL Section 1 6 Introduction User Manual The PICO VO XXL Washer Disinfector The PICO VO XXL range of washer disinfec tors have been designed to clean various sur gical 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 cycl
25. asured field strength in the location in which the PICO VO XXL is used exceeds the applicable RF compliance level above the PICO VO XXL should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orientating or relocating the PICO eVO XXL b Over the frequency range 150 kHz to 80 MHZ field strengths should be less than 3 V m Ref PICO EVO XXL UM 47 03 13 Rev A Page 47 of 48 PICO evo XXL Appendix I EMC amp Electromagnetic compatibility Data User Manual IV R mmen ration distan between rtabl nd mobile RF equipment and the PICOeVO XXL mmunication The PICO VO XXL is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the PICO VO XXL can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the PICO VO XXL 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 2VP d 2 3VP 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
26. cacy Test b Perform test by using standard PCD ki Process Challenge Device or equivalent Ref PICO EVO XXL UM 29 03 13 Rev A Page 29 of 48 PICO evo XXL Section 3 9 Manufacturer Recommendations User Manual Washer Disinfector 1 Conforming to HTM 01 05 Dentistry 1 x Annual service visits per year known as Pay as you go see pages 6 amp 8 of the Service Contract for further details Performed by a fully accredited service engineer Please note that high end users may consider 4 on site visits 2 Conforming to HTM 20 30 Hospital 4 x Service visits per year Bronze or Silver See pages 6 7 amp 8 of the Service Contract for further details Performed by a fully accredited service engineer 3 Weekly protein test Protest Quick 4 Monthly cleaning efficacy test PCD kit As with all technical precision equipment the Pico washer disinfector requires regular servicing and maintenance to ensure consistent validated performance And we also recommend a number of consumable items are changed annually Please refer to page 10 Pico Service Pack within the Service Contract Testing Required 50 x Protest Q Ready to use rapid protein residue detection system for testing any surface after the cleaning process and hard to reach places on _ dw RPR em complex instruments such as serrated edges or box joints will turn from green to purple if protein is present in the sample Also available in
27. creen will now be dis played 3 Press START button once and following message will be displayed Seu GE Set Clock amp Prog TIME _ 0 0 TIME 00_00 40 4 Press START button three times and cursor will move from hours to minutes and then display will show DATE option as below Set Clock DATE _01 5 On pressing START button three times the cursor will move from date to month and at the end it will be blinking under the year Press START again and Prime AWT Pump will be shown as below Prime AWT Pump At this point press and hold START but ton This will switch ON AWT pump and AWT fluid will be purged through the hose Keep start button pressed until AWT can be seen through water inlet diffuser and then take off the finger from START button The water inlet diffuser location shown in the picture below Water inlet diffuser Press DOOR RELEASE button twice to go back to standby mode as shown on display as below check Detergent Ref PICO EVO XXL UM 31 03 13 Rev A Page 31 of 48 PICO CVO XXL Section 3 11 Purging Chemical After Replacement WARNING Before handling of any chemical please read Chemical Safety Information on page 8 After replacing the new chemical container it is important to purge chemical through the empty chemical hose to take out all blocked air Please follow chemical safety informat
28. ct 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 logging device
29. d open door by pressing Door Release button Remove basket and accessory pack see important note above Your PICO VO XXL has been despatched with a range of accessories to enable easy installa tion and efficient operation Their use is detailed throughout this manual Ensure that all these items are present before attempting to install or operate the unit Complete the following Enclo sures Check List and notify your supplier of any shortages or damaged components as soon as possible Enclosures Check List 1 x Blue cold water hose 1 x Red Hot Water hose 1 x Evo Tray 1 x Handpiece adaptor with manifold 1 x Tray rack system 1 x Dental Burr Basket 1 x Cassette 10 Blue 1 x Printer Lead 1 x Door Release Probe 1 x 4L Bottle 3E Zyme detergent 1 x Bottle AWT Fluid 500ml 1 x Chemical pick up tube 1 x AWT pick up tube 1 x Mains power lead 1 x PICOeVO XXL test documentation Printer Printer or 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 wa ter treatment fluid may be purchased from your supplier using the following codes 3E Zyme MED8035 1 x 4 Litre bottle AWT Fluid MED1000 09 4x 0 5 Litre bottles AWT Fluid M20059 1 x 4 litre bottle Important Note Using non appr
30. d be noted that the cables provided with the PICO VO XXL should not be used on other eguipment To do so may result in increased emissions or decreased immunity of the other eguipment in relation to EMC performance 8 The PICO VO XXL should not be used adjacent to or stacked with other equipment If adjacent or stacked use with other equipment is necessary the PICO VO XXL 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 PICO amp eVO XXL has an essential performance as follows 1 Functions within the operating cycle should continue to operate as normal the product should com plete it s operating cycle correctly wash disinfect water temperature should remain at 93 deg C 1 deg C 2 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 3 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 4 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 actu
31. e 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 aborted General Wash The PICO VO XXL 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 PICOeVO XXL adds the facility to wash and disinfect the inside of lumen devices such as dental hand pieces which are connected on high pressure handpiece manifold Auto Dosing All PICO VO XXL models are supported by Automatic Dosing System which introduces a controlled amount of detergent from an exter nal container during the appropriate stage s of a wash cycle Washing Washing is achieved using unigue 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 5 Disinfecting Effective thermal disinfection is achieved by raising the temperature of the final r
32. e Basic Warranty Items 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 defects 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 pla
33. e your warranty Ref PICO EVO XXL UM 14 03 13 Rev A Page 14 of 48 PICO GVO XXL Section 2 2 Installation Requirements User Manual NOISIA38 ND3 NOldlsDs3a A8 aaAOaadY 3170 uJung PUD upajo PTT udopnedWYJ W G3WV tDqDIDP PON 7 C 10 GEN si j uullltu ul suolsu uulp V paylpads siwu ulO ssejun P lttuI Towert 1900 peyloeds esyweulo ssejun seoupielol DNewa av 1XX OAs ODId m O gt m m SHOU UO onpold pup s 6p dioys suing jjo e oueu usu 40812 Poo6 sinsu3 eo z x YY RRA A YY ANN 200 LLIN gt Y 22200 24440 Y 00000 N amp 0 y WN Y HOON RRR NO ON Wy Y YN SNR NOOO OONN O NA 06606 Sw Ay 2 QAN Y 845 Ref PICO EVO XXL UM 15 03 13 Rev A Page 15 of 48 PICO CVO XXL Section 2 3 Installation User Manual Important Note Medisafe UK Ltd strongly advise that this prod uct be installed and commissioned by Medisafe or by a suitably qualified person before use Connecting the Washer Disinfecto
34. ersons must be completed by the Engineer conducting 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 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 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 XXL UM 41 03 13 Rev A Page 41 of 48 PICO evo XXL Section 4 6 Decontamination Guide User Manual
35. 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 Ctrl 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 PICO VO XXL will be receiving 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 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 PICO VO XXL is connected PicoHyper H minal Fie Edt View Cal Transfer Help Dm sneg Em Washer ID 1H15526 Cycle No 00
36. hrough the application of all 18 rules within Annex IX of the Medical Devices Directive 93 42 EEC C 0473 Environmental Policy Waste electrical and electronic products must not be disposed of with household waste Please recycle where facilities exist Check with your Local Authority or Distributor for recycling advice z Manufacturer Information 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 XXL UM 11 03 13 Rev A Page 11 of 48 PICO GVO XXL C N PICO CVO XXL Section 2 Installation Medisafe International Twyford Road Bishop s Stortfor 279 461641 F 44 0 1279 461643 www med safeinternation Section 2 1 Unpacking User Manual Caution EXCESSIVE WEIGHT HAZARD To avoid back or other injury have two persons to lift the washer Carefully open the carton and with the help of two persons lift the machine Please retain the carton and all packaging 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 an
37. ich 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 WARRANTY 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 XXL UM 40 03 13 Rev A Page 40 of 48 PICO CVO XXL Section 4 5 Service Record User Manual Medisafe recommend that your PICO VO XXL 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 p
38. inse 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 international 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 Inhibitor 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 XXL UM 10 03 13 Rev A Page 10 of 48 PICO GVO XXL Section 1 6 Introduction User Manual Compliance All variants in the PICO VO XXL 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 PICO VO XXL 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 IIa devices t
39. ion on page 35 To purge chemical through the test mode follow the steps below 1 Following two messages can be shown on LCD display before start of procedure If display shows Load Instruments then go to step no 4 If display shows Check Detergent then go to step no 2 2 To clear this user need to switch off the machine from the mains switch on the wall and switch back ON This will then display Program Aborted Power Failure 3 Press DOOR RELEASE button once to open the door Once door is open press DOOR RELEASE button again for at least 5 sec onds The following screen will now be dis played 4 Press START button once and following message will be displayed 5 Press START button three times and cursor will move from hours to minutes and then display will show DATE option as below 6 On pressing START button three times the 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 will be shown as below 8 Press START and Prime Det Pump will be shown as below 9 To purge the detergent press START to switch ON detergent pump and it will count the detergent guantity from 00 to 10 This is shown on right hand side of the display When detergent pump is ON display shows Det ON and after counting up to 10 it stops automatically and shows Det OFF 10 Press START again to prime detergent a
40. isinfector 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 Ref PICO EVO XXL UM 42 03 13 Rev A Page 42 of 48 PICO GVO XXL 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 C oo Serial No Hospital Name Signature Ref PICO EVO XXL UM 43 03 13 Rev A Page 43 of 48 PICO evo XXL Appendix I EMC amp Elect
41. nd repeat this procedure until detergent can be seen coming through the water inlet diffuser The water inlet diffuser location inside the chamber is identified in the picture on previous page 11 Once detergent is purged press DOOR RELEASE button twice to go back to standby mode as below Ref PICO EVO XXL UM 32 03 13 Rev A Page 32 of 48 User Manual PICO GVO XXL Section 3 12 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 Identify the emegency door release hole on right hand side of the machine Fig 1 3 Insert Door Release Probe into exposed hole and push firmly 4 The loading door will now be released Fig 1 Emergency door open access Ref PICO EVO XXL UM 33 03 13 Rev A Page 33 of 48
42. nd additives are approved and recommended for use in this product Using non approved chemicals may cause damage to the product and could void 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 XXL UM 7 03 13 Rev A Page 7 of 48 PICO CVO XXL 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 l
43. nt 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 nature of the potential hazard and any actions which have to be taken to avoid them A This symbol alerts you to situations that may cause serious body harm death or property damage Warning A This symbol alerts you to situation that may cause body injury or property damage Caution voltages are present inside the product Do not remove the outer casing Refer Warning servicing and repair to qualified personnel only This symbol indicates the presence of electric shock hazards Dangerously high Important Note This symbol indicates that Important Note s are manufacturer s recommendation 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 contact your local recycling authorities for collection centres 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 XXL UM 6 03 13 Rev A Page 6 of 48 PICO evo XXL Section 1 3 Important Safety Information User Manual Electrical
44. ntaining 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 the corre
45. old 50 609C Hot Ref PICO EVO XXL UM 37 03 13 Rev A Page 37 of 48 PICO CVO XXL Section 4 3 Technical Specifications User Manual Hardness Caco3 Not more than 55ppm as per 565 mm h HTM0105 refer page 65 clause 17 10 Above this value AWT will must be Outer Cabinet Dimensions 450 mm w used during the cycle 600 mm d Drain 860 mm h Connection on product 2 x 18mm outside dia Carton Dimensions 485 mm w unthreaded hose tail 700 mm d Service connection required 885 mm h 2 x 11 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 90 C Ventilation Maximum temperature of load 90 C Chemicals Size and Nature of Containers AWT Fluid 0 5 litre plastic bottle with spout 3E Zyme 5L bottle with screw cap Medi PH Safe 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 60kg empty Operational Weight 85kg with fluids Shipping Weight 70kg Dimensions Wash Chamber Volume 108946 0 cm3 Wash Chamber Dimensions 380 mm w 470 mm d 610 mm h Loading door aperture
46. oltage power supply network that supplies buildings used for domestic purposes Harmonic emissions A IEC61000 3 2 L Voltage fluctuations flicker emissions Complies Ref PICO EVO XXL UM 45 03 13 Rev A Page 45 of 48 PICO GVO XXL Appendix I EMC amp Electromagnetic compatibility Data User Manual III Guidance and manufacturer s declaration electromagnetic immunity The PICO VO XXL is intended for use in the electromagnetic environment specified below The customer or the user of the PICO VO XXL should assure that it is used in such an environment Immunity test IEC 60601 Compliance level Electromagnetic environment Guidance Test level Electrostatic 6 kV contact 6 kV contact Floors should be wood 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 IEC61000 4 2 least 30 Electrical fast transient burst IEC61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines Input output line tests not applicable Mains power quality should be that of a typical commercial or hospital environment Surge IEC61000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage
47. oved chemicals accessories and replacement parts may cause damage to this product and could result in disputed warranty claims Please read safety instructions before us ing any chemical on section 1 4 Ref PICO EVO XXL UM 13 03 13 Rev A Page 13 of 48 PICO CVO XXL 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 90kgs 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 CaCO3 lt 55ppm as per HTMO105 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 74 BSP male thread Cold 1 x shut off valve with 74 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
48. packs of 25 or 100 10 x CEI Cleaning Efficacy Indicator Cleaning efficiency check is designed for the Validation and the routine monitoring of the cleaning efficacy of cleaning processes in washer disinfectors for surgical instruments 1 x Standard PCD box Container system for Valisafe CEI Cleaning efficacy Indicator creating a realistic and repeatable challenge Process Challenge Device PCD for standard general non lumen Instrumentation Ref PICO EVO XXL UM 30 03 13 Rev A Page 30 of 48 PICO evo XXL Section 3 10 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 fluid for up to 70 wash and disinfect cycles dependent upon water hardness and default settings used On completion of 50 cycles the LCD DISPLAY will indicate that more fluid is required and the unit will not proceed with a new wash and disinfect cycle until you confirm that it has been added After replacing AWT bottle it is important to purge AWT through the empty inlet hose to take all blocked air To purge AWT manually follow steps below 1 Ensure that the following screen is dis played before attempting to go into test mode Load HE 2 Press DOOR RELEASE button once to open the door Once door is open press DOOR RELEASE button again for at least 5 sec onds The following s
49. pliance with the guidelines identified as acceptable by in ternational decontamination standards it is recommended 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 gualified engineer Daily Checks What to do and How to do it Select a recent printout if a printer is 1 Verify accuracy of electronic control connected and compare parameters systems with the first printout generated after installation Clean with a weak mixture of detergent 2 Check cleanliness of all external surfaces gt 9 and water 3 Check that the inside of the wash chamber is Clean with a weak mixture of detergent clean and free from any deposits and water 4 Check that the perforated sump cover at the Cleaning with AWT Fluid and then flush bottom of wash chamber is not clogged through with fresh water restriction Check that holes in the rotating spray bar are 5 not blocked and it is free to rotate without Remove spray arm by unscrewing gt 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 7 Check door operation Ensure that loading door
50. quipment should be used no closer to any part of the PICO amp eVO XXL 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 IEC61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m 3 V m d 1 2VP 80 MHz to 800 MHz IEC61000 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 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 me
51. r 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 drains and suitable hot and cold water supply as detailed with in the Installation Requirements Mains isolation is achieved by removing the plug so ensure that the outlet is easily accessible Important Note The PICO VO XXL washer disinfector must earthed Connect the mains plug into the switched out let and switch on This product must be con nected to a suitable mains power supply to enable the loading door to be released 3 Open door and remove any protective packaging and loose items from inside the wash chamber Close door switch mains off at power outlet and remove mains plug 5 Identify two grey plastic convoluted drain hoses attached at the back of the unit Con nect these hoses to suitable mains drain sited below the level of the drain outlet on the unit Identify the blue and Red water supply hoses supplied with the unit Connect both of them RS232 Data lead connection for Printer Detergent amp Medi Logger Power Cord Condenser Drain Mains Drain AWT 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 Ensure that the black plastic washer fitted to the supply hose end is in place before tightening Chemical Safety Note Befo
52. re handling of any chemical please read Chemical Safety Information on Section 1 4 7 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 Fit connector on other end of pick up tube to quick release port labelled as Detergent Similarly remove the cap from AWT bottle 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 im portant to purge detergent and AWT before using the machine The guidelines to purge detergent and AWT are given on page 32 and 33 respectively Turn ON the water supply and check for any leaks Your PICO VO XXL Washer Disinfector is now ready to use 10 11 12 13 14 RO Water Supply Hot Water Supply Cold Water Supply Ref PICO EVO XXL UM 16 03 13 Rev A Page 16 of 48 PICO CVO XXL Section 2 3 Installation User Manual Connecting the Printer If supplied 1 Identify the RS232 Data Lead supplied with the PICO VO XXL Connect the 3 5mm jack plug to the data port on the lower rear panel of the PICOeVO xxL unit 2 Connect the multi pin plug on the other end of the RS232 Data Lead to the con nector on the rear of the printer
53. romagnetic compatibility Data User Manual I Special Instructions Notes regarding the PICO amp 6VO xxL and Electromagneti mpatibil ity EMC testing to EN 1 1 2 2007 1 The PICO VO XXL has been tested regarding it s ability to operate in an environment containing other electrical electronic eguipment including other medical devices 2 The purpose of this testing is to ensure that the PICO VO XXL is not likely to adversely affect the normal operation of other such eguipment and that other such eguipment is not likely to adversely affect the normal operation of the PICO VO XXL 3 Despite the testing of the PICO GVO XXL that has been undertaken normal operation of the PICO eVO XXL can be affected by other electrical electronic equipment and portable and mobile RF communi cations eguipment 4 As the PICO VO XXL is medical equipment special precautions are needed regarding EMC electro magnetic compatibility 5 Itis important that the PICO VO XXL is configured and installed put into service in accordance with the instructions guidance provided herein and is used only in the configuration as supplied 6 The PICO VO XXL s data cable must be restricted to less than 3m in length and should not be ex tended by the user If the PICO VO XXL is used with adapted cables or cables other than those supplied this may result in increased emissions or decreased immunity of the PICO VO XXL in relation to EMC performance 7 It shoul
54. ted 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 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 XXL UM 39 03 13 Rev A Page 39 of 48 PICO CVO XXL 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 wh
55. y at 40 C Mains supply voltage fluctuations up to 10 of the nom inal voltage Transient over voltages typically present on the mains supply Over voltage Category II Pollution Degree 2 Wash Cycle Parameters Wash temperature Nominal 42 C Using 3E Zyme solution Disinfection conditions Moist heat 90 C Accuracy of temp measurement lt 2 90 C Volume of dispensed chemicals AWT Fluid 3E Zyme Required Services Electricity Supply Supply type required Power consumption Termination Pico Termination Printer Method of disconnect Water Supply Connection on product 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 34 BSP Male Union cold 1 x 34 BSP Male Union Hot Shut off valve with 34 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 259C c
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