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PCF Pro User Manual

DOC01851

Page 64 of 74

Applied Standards

Standard

Description

2006/42/EC

Machinery Directive

ISO 13849-1:2006

Safety of machinery - Safety-related parts of control systems -- Part

1: General principles for design

ISO 13849-1:2012

Safety of machinery - Safety-related parts of control systems -- Part

2: Validation

BS EN 60204-1:2006+A1:2009

Safety of machinery. Electrical equipment of machines. General

requirements

BS EN ISO 15883-1:2009 +A1:2014

Washer-disinfectors. General requirements, terms and definitions

and test

MDD 93/42/EEC

Medical Device Directive

BS EN ISO 15883-2:2009

Washer-disinfectors - Requirements and tests for washer-disinfectors

employing thermal disinfection for surgical instruments, anaesthetic

equipment, bowls, dishes, receivers, utensils, glassware, etc.

BS EN 61010-1:2010

Safety requirements for electrical equipment for measurement,

control, and laboratory use

BS EN 61010-2-040:2015

Particular requirements for sterilizers and washer-disinfectors used to

treat medical materials

BS EN 60601-1-6:2010+A1:2015

Medical electrical equipment. General requirements for basic safety

and essential performance

BS EN 60601-1:2006 +A12:2014

Medical electrical equipment. General requirements for basic safety

and essential performance

BS EN 60601-1-2:2007

Medical electrical equipment. General requirements for basic safety

and essential performance. Collateral Standard. Electromagnetic

disturbances. Requirements and tests

BS EN 62366-1:2015

Medical devices. Application of usability engineering to medical

devices

BS EN ISO 13485:2012

Medical devices - Quality management systems

BS EN ISO 14971:2012

Medical devices - Application of risk management to medical devices

PD IEC/TR 60878:2015

Graphical symbols for electrical equipment in medical practice

BS EN 1717:2000

Protection against pollution of potable water in water installations and

general requirements of devices to prevent pollution by backflow

PD 5304:2014

Guidance on the safe use of machinery

EN 61326: 2013

Electrical equipment for measurement, control and laboratory use.

EMC requirements. General requirements

2003/10/EC

Minimum health and safety requirements regarding the exposure of

workers to the risks arising from physical agents (noise)

2009/104/EC

Minimum safety and health requirements for the use of work

equipment by workers at work

Содержание PCF Pro

Страница 1: ...DOC01851 PCF Pro User Manual...

Страница 2: ...the written permission of MEDISAFE be either a used released disclosed or reproduced in whole or in part or b used in whole or in part for manufacture except that i such release disclosure or use is n...

Страница 3: ...Leslie 12 Jan 17 2 Updated certification section direction pump changed carrier name to basket E De Bruijn 11 Aug 17 3 Updated PCF Pro parameters Added copyright information table of revision luer pi...

Страница 4: ...n 18 Heat 18 Electrical Safety 18 Service Contracts Warranty 18 Validation Option 18 2 INSTALLATION 19 Transport and Storage 20 Marking 20 Environmental 20 Lifting 20 Unpacking 20 Returns 20 Enclosure...

Страница 5: ...Light Guard 40 Safety Edge 40 Emergency Stop 40 Testing Operation of the Safety Devices 41 To check operation of the carrier lift 41 Starting a Cycle 42 Automated Wash Cycle 43 Cycle Process 43 Pre wa...

Страница 6: ...ecifications 60 Applied Standards 64 6 APPENDICES 65 EMC 66 EMC Electromagnetic Compatibility Data 66 Electromagnetic Emissions 67 Electromagnetic Immunity 68 Separation Distances Between PCF Pro and...

Страница 7: ...DOC01851 Page 7 of 74 1 Introduction 1 Introduction User Manual...

Страница 8: ...om Manufacturing Sales Customer Service Technical Support Medisafe UK Ltd Unit 1 Twyford Industrial Estate Twyford Road Bishop s Stortford Hertfordshire CM23 3LJ England Tel 44 0 1279 461641 Fax 44 0...

Страница 9: ...ns are important to protect the health and safety of personnel operating the Ultrasonic Cleaning System and should be retained in a conveniently accessible area for quick reference Advisory A listing...

Страница 10: ...ssioning the PCF Pro for warranty registration purposes Where no value is required write pass or fail with a comment if necessary For installation instructions and contact information for qualified pe...

Страница 11: ...ter Hardness As specified by WD Manufacturer 125 ppm max Cold Water Hardness As specified by WD Manufacturer 125 ppm max Hot Water Temperature 50 C 122 F min 80 C 176 F max Cold Water Temperature 5 C...

Страница 12: ...autions and instructions on detergent label and in the Material Safety Data Sheet MSDS prior to handling chemical refilling chemical containers or servicing chemical injection pumps and lines Wear app...

Страница 13: ...id or condensation If spills or leaks could contain detergents or other chemicals follow safety precautions and handling procedures set forth on detergent or chemical label and or MSDS Warning Persona...

Страница 14: ...n as surface grain Abrasive cleaners damage stainless steel Cleaner rubbed in a circular motion or applied with a wire brush or steel wool will scratch and dull stainless steel Avoid running equipment...

Страница 15: ...he training schedule shall include Operation of the machine see section 2 10 3 1 3 4 1 3 4 2 3 5 3 7 3 8 3 9 and 3 12 Safe use of machine see section 1 5 Chemical handing see section 3 6 Emergency Pro...

Страница 16: ...recycling targets are met For independent confirmation of Medisafe UK Ltd status can call B2B Compliance on 0845 680 9829 or visit www b2bcompliance org uk To fulfil our B2B WEEE take back obligations...

Страница 17: ...nd offer the option of a disinfection stage at the end of the wash There are six pre defined user selectable programs with Pre wash Wash Rinse and Disinfection stages tailored to clean a multitude of...

Страница 18: ...repair to qualified personnel only It is expected that any person servicing or repairing the PCF Pro will be a competent engineer with an understanding of electrical safety and knowledge of three pha...

Страница 19: ...DOC01851 Page 19 of 74 2 Installation 2 Installation User Manual...

Страница 20: ...Care must be taken not to knock or crush it with the forks as this could result in irreparable damage to the drain and tank assembly Unpacking Retain all packaging materials if for any reason the unit...

Страница 21: ...t items can be ordered see below list for details Note The below depends on your machine type please refer to what has been specified on your order PCF Pro Accessory Kit MP21223 Quantity Part No Descr...

Страница 22: ...r warranty and your guarantee of performance Printer Part No Description MED1014B Thermal printer including power supply paper and USA plug MED1014C Thermal printer including power supply paper and Eu...

Страница 23: ...ral Blue Earth Green Yellow The cable must be protected with a 3phase Residual Current Device RCD and Miniature Current Breaker MCB The RCD and MCB shall only be used to supply this equipment The disc...

Страница 24: ...th suitable traps Position Drain entry and the entire drain hose must be below the machine drain outlet Drain gulley pipe ID at least 100mm 4in to conform with EN ISO15883 Capacity 180ltr m 47 5 US ga...

Страница 25: ...ess steel water hose supplied with the unit Ensure the seal in the hose end is in place and screw the elbow connector onto the cold water inlet at the lower rear of the unit 9 Connect the straight end...

Страница 26: ...PCF Pro User Manual DOC01851 Page 26 of 74 Installation Drawings Rear View Showing Services...

Страница 27: ...PCF Pro User Manual DOC01851 Page 27 of 74 Front View...

Страница 28: ...PCF Pro User Manual DOC01851 Page 28 of 74 Left Side View with Lid Closed showing Drain Connection...

Страница 29: ...PCF Pro User Manual DOC01851 Page 29 of 74 Left Side View Lid Open...

Страница 30: ...the green led will illuminate and printing will resume The printer can store more than 10 cycles in memory when the paper has run out If the power is not removed when changing the paper the stored cyc...

Страница 31: ...DOC01851 Page 31 of 74 3 Operation 3 Operation User Manual...

Страница 32: ...cted wash program Chemical 1 Prime chemical pump 1 Chemical 2 Prime chemical pump 2 Clock Set the time and date Data Logging Download logged cycle data onto a USB Flash Drive Information Serial number...

Страница 33: ...ift system can be used it must zero its position sensor If the machine was powered off and the carrier lift was not fully open or closed then the display will show Press and hold until the carrier lif...

Страница 34: ...t saving hours While the machine is off a backup battery maintains the time and date Set Time 1 Use the scroll arrows to cycle through to the clock icon 2 Press Set Time 3 Use the arrows to adjust the...

Страница 35: ...s Units Program Number Express Deluge Wash Disinfect Only da Vinci Wash Cycle Cannulated Instruments General Inst Mild Alkaline da Vinci Disinfect Cycle P1 P2 P3 P4 P5 P6 Pre wash Chemical ml 190 0 0...

Страница 36: ...will give between eight and eleven washes The machine weighs the chemical to detect when there is insufficient chemical to run a cycle prompting the user to replace the bottle before the cycle begins...

Страница 37: ...baskets moving during operation they are locked into position with securing flags Basket Removal To remove the basket push the thumb ball up on both sides of the rack The flags will drop down allowing...

Страница 38: ...replacement sooner than 12 months The user must inspect the luer pipes before every use and replace if required Note Replace all luer pipes at the same time Caution Do not allow Luer pipes to protrude...

Страница 39: ...s Always follow the manufacturer s instructions Instrument Loading Precautions When loading instruments into a basket observe the following precautions Do not place items directly into the wash tank o...

Страница 40: ...yed Note If the Carrier Lift was travelling down when a fault is detected to release an obstruction it will stop reverse travel up a few centimetres and stop Once the obstruction is removed from the l...

Страница 41: ...limit fault message is shown please contact Medisafe to resolve the fault To check operation of the safety edge 1 While moving the carrier press the safety edge and confirm the carrier lift stops and...

Страница 42: ...ace chemical s see section 3 6 2 and press OK to continue or press Cancel to abort the cycle start 3 Insert the bottom basket into machine and latch see section 3 7 2 4 Press and hold the Load foot pe...

Страница 43: ...o the set point circulatingthrough the lumens and spray arms Degas Pulse ultrasonics on and off for the degas period with no recirculation Cycling Alternate between ultrasonics 45s and lumen flushing...

Страница 44: ...drained Wash The tank is filled to the top level with a mix of hot and cold water to attain the set temperature Once the water reaches the mid level a quantity of detergent is dispensed into the tank...

Страница 45: ...e heating the water up to the temperature set point Finally all water in the tank is drained Final Rinse Disinfection The machine fills with hot water or RO if fitted to the minimum level Once the tan...

Страница 46: ...he cycle has completed with no errors Unload The unload sequence is optimised for hands free operation where the Load foot pedal is used to step through an automated sequence 1 Press and hold the Load...

Страница 47: ...he set point by more than 10 C the cycle will be aborted see section 3 9 10 At the end of a wash stage press Yes on the screen to reuse the water again Unload the instruments see section 3 9 9 then lo...

Страница 48: ...pair the machine If an error occurs An audible alarm will sound The LED Edge will flash red see section 3 12 An error code and description will be shown on the display The printer will output the Erro...

Страница 49: ...as a DISINFECTANT cleaner In the interests of health and safety all medical washers should be cleaned on a weekly basis as part of a routine maintenance program This will ensure the machine is safe f...

Страница 50: ...they are not kinked or ruptured In accordance to ISO15883 the international standard for the performance of Washer Disinfectors we advise the checks stipulated below However each hospital may follow i...

Страница 51: ...hecks 2 Check water hardness of hot and cold water supplies 3 Check water conductivity of final rinse water supply 4 Check condition of mains water supply hoses 5 Visually inspect water and drainage s...

Страница 52: ...ycle Therefore it should already be clean and disinfected by the end of a cycle Full Decontamination On a weekly basis 1 Perform the daily cleaning procedure 2 Fit luers to all basket ports to ensure...

Страница 53: ...dance with the appropriate hospital procedure for equipment of this type When returning this product to your supplier the form must be completed and attached to the outside of the crate carton If it i...

Страница 54: ...the log icon 2 Insert the USB flash drive into the USB data port Note the flash drive must be formatted as FAT32 3 Press All Logs to download all cycle logs or New Logs to download the cycle logs sin...

Страница 55: ...DOC01851 Page 55 of 74 4 Troubleshooting 4 Troubleshooting User Manual...

Страница 56: ...t showing the error Error Messages Error Code Error Message Possible Causes and Solutions 1 Mains Power Removed Check mains supply to unit was not interrupted during a cycle 2 Chamber Overflow Switch...

Страница 57: ...ne is turned on 39 40 41 43 45 46 47 Sonic Generator Fault Switch the machine off then on again 42 Maximum Cycle Time Expired Check water supply flow rate is sufficient Check tank filter clear ensure...

Страница 58: ...si Check water inlet valve is not blocked beware of hot water temperature Low Irrigation Port Flow Rate Check all connectors are fully inserted Clean tank filter Check basket manifold ports are not bl...

Страница 59: ...DOC01851 Page 59 of 74 5 Technical 5 Technical User Manual...

Страница 60: ...tion of machine status Blue LED Loading Illumination Baskets Quantity 3 baskets per machine Features Two 10 way manifolds per standard basket one on each end With ten ports open each manifold outputs...

Страница 61: ...38US gal Total Cycle 680ltrs 180US gal Consumption will vary depending on the cycle selected and the site facilities Electrical Supply General Mains supply voltage fluctuations up to 10 of the nominal...

Страница 62: ...8 F decreasing linearly to 50 relative humidity at 40 C 104 F Noise Max SPL 69dBA 1m from the front of the machine Drainage System Type Gravity Drain Connection 54mm 2 125in OD outlet Overflow Intern...

Страница 63: ...nternal Data Storage Type Micro SD FLASH Card Typical Capacity 4GB 1 Million cycles Range and Accuracy Water Temperature Measurement range 2C to 98C 36 F to 208 F Displayed and printed to the nearest...

Страница 64: ...ipment General requirements for basic safety and essential performance BS EN 60601 1 2006 A12 2014 Medical electrical equipment General requirements for basic safety and essential performance BS EN 60...

Страница 65: ...DOC01851 Page 65 of 74 6 Appendices 6 Appendices User Manual...

Страница 66: ...Pro may be supplied with the following accessories serial data cable MED1017 and thermal printer MED1014 1 The PCF Pro s data cable must be restricted to less than 3m in length and should not be exte...

Страница 67: ...nt guidance RF emissions CISPR 11 Group 1 The PCF Pro uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby elect...

Страница 68: ...ns power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT For...

Страница 69: ...lds strengths from fixed RF transmitters as determined by an electromagnetic site survey see Note a should be less than the compliance level in each frequency range see Note b Interference may occur i...

Страница 70: ...maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 KHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0...

Страница 71: ...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 PCF Pro Normal deterioration or damage to...

Страница 72: ...rviced by Date Serviced by Date Cycles since last service Cycles since last service Cycles since last service Next service due Cycles Date Next service due Cycles Date Next service due Cycles Date 12...

Страница 73: ...6 2545 26 4565 46 6585 66 8525 7 2626 27 4646 47 6666 67 8686 8 2727 28 4747 48 6776 68 8787 9 2848 29 4868 49 6888 69 8828 10 2989 30 4929 50 6949 70 8969 11 3070 31 5090 51 7030 71 9050 12 3171 32 5...

Страница 74: ...sold in the EEA The 4 digit number below the CE mark is the identification number of the notified body involved in the conformity assessment procedure WEEE directive Shows that a product can be recyc...

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