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Summary of Contents for Medisafe PCF Pro
- Page 1 PCF Pro User Manual DOC01851...
- Page 2 (iii) MEDISAFE is notified of such release, disclosure or use.
- Page 3 PCF Pro User Manual Record of Revisions EVISION ESCRIPTION OF HANGE OCATION OF HANGE UMBER Original Issue. W. Leslie 12-Jan-17 Updated certification section, direction pump, changed E. De Bruijn 11-Aug-17 carrier name to basket. Updated parameters. Added copyright W. Leslie 24-Aug-17 information, table of revision, luer pipes sections.
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Page 4: Table Of Contents
Environmental ..............................20 Lifting ..............................20 Unpacking .............................. 20 Returns ..............................20 Enclosures Check List ..........................21 PCF Pro Accessory Kit (MP21223) ........................21 PCF Pro Plumbing Kit (MP21225) ........................21 Additional Accessories ........................... 22 Printer ................................22 Approved Chemicals ............................22 Installation Requirements ........................ - Page 5 PCF Pro User Manual Menu ..............................32 Power Up ............................... 33 Authorisation code ..........................33 Setting Time & Date ..........................34 Set Time ................................34 Set Date ................................34 Selecting a program ..........................35 Standard Program Parameters......................... 35 Chemical Handling ..........................36 Chemical Consumption ............................
- Page 6 EMC .................................. 66 EMC & Electromagnetic Compatibility Data ..................66 Electromagnetic Emissions ........................67 Electromagnetic Immunity ........................68 Separation Distances Between PCF Pro and Mobile RF Equipment ............70 Warranty ..............................71 Service Record ............................72 Operator PIN Number Codes........................73 Symbols Glossary ...........................
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Page 7: Introduction
1. Introduction 1. Introduction User Manual DOC01851 Page 7 of 74... -
Page 8: Medisafe Contact Details
PCF Pro User Manual Medisafe Contact Details United Kingdom (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) 1279 461643 E-mail info@medisafeinternational.com... -
Page 9: Independent Monitoring
It is advised that an independent monitoring system is fitted in accordance with ISO 15883-1:2009 - Washer-disinfectors. Service and Maintenance Requirements The PCF Pro should be serviced on a regular basis to ensure that the product continues to perform in accordance with its design parameter, see section 6-6 for more information. DOC01851... -
Page 10: Pcf Pro Warranty Registration
(this does not affect your statutory rights as a customer). A copy of this form must be sent to your local Medisafe authorised distributor to validate the warranty. - Page 11 PCF Pro User Manual Part 1, Test Type Acceptable Value Result Comments Test Through beam sensor basket obstruction along machine front edge during downward motion halts lifting system then raises up by approximately 30mm Test Through beam sensor basket obstruction along...
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Page 12: Safety Precautions
PCF Pro User Manual Safety Precautions The following Safety Precautions must be observed when operating or servicing the PCF Pro. WARNING indicates the potential for personal injury and CAUTION indicates the potential for damage to equipment. For emphasis, certain Safety Precautions are repeated throughout the manual. It is important to review ALL Safety Precautions before operating or servicing the unit. - Page 13 • Regularly scheduled preventive maintenance, in addition to the faithful performance of routine maintenance described within the service manual, is required for safe and reliable operation of this equipment. Contact Medisafe to schedule preventive maintenance. • Failure to perform periodic service inspections of the machine could result in serious personal injury or equipment damage.
- Page 14 • Always dissemble instruments that are designed to be taken apart. • Visually inspect instruments after reprocessing • If any instruments became detached from the Medisafe connection tubing during processing, they should be reprocessed after ensuring that the Luer connection is firmly seated.
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Page 15: Training Personnel
PCF Pro User Manual Training Personnel The owner of this equipment has the responsibility for training the users and keeping the appropriate records. There should be regular training of all personnel concerned with the operation and maintenance of the equipment. The 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- •... -
Page 16: Compliance
PCF Pro User Manual Declaration of CE Conformity Compliance The PCF Pro is designed and manufactured in The PCF Pro has been designed to perform the UK by Medisafe UK Ltd. and complies with within guidelines recommended the essential requirements of the Medical international decontamination Standards. -
Page 17: Intended Use
Drying Concept Summary To clear the excess water from the irrigation The PCF Pro has been designed as a stand- and spray channels, compressed air is alone high pressure sonic irrigation washer alternately injected at regular intervals. disinfector, with the ability to wash up to sixty... -
Page 18: General Safety
Service Contracts & Warranty Medisafe, may be hazardous. Therefore, Your PCF Pro is supplied with a conditional always read the manufacturer’s chemical 12-month parts warranty, which is effective safety information before use and never use from the date of installation. -
Page 19: Installation
2. Installation 2. Installation User Manual DOC01851 Page 19 of 74... -
Page 20: Transport And Storage
50kPa to 106kPa Returns Before transporting a used PCF Pro, it is vital that all fluid is thoroughly drained from the machine. If returning the unit to your supplier or Medisafe UK Ltd it MUST first be fully Humidity range decontaminated before transporting. -
Page 21: Enclosures Check List
Enclosures Check List and notify your supplier of any shortages or damaged components as soon as possible. The PCF Pro comes with three baskets, instrument tubing, and distal connectors for reverse flushing. Replacement items can be ordered, see below list for details. -
Page 22: Additional Accessories
Additional Accessories A range of Medisafe approved accessories including replacement parts and consumables, may be purchased from your supplier. The use of these compatible Medisafe approved products will ensure the continued and reliable operation of your machine. Note: Using non-approved chemicals, accessories, and replacement parts may cause damage to the machine and could void both your warranty and your guarantee of performance. -
Page 23: Installation Requirements
Mains Supply Cables shall be rated for maximum current of the equipment, meeting the requirements of IEC 60227 or IEC 60245. The PCF Pro is supplied with 2m of screened power cable. 200 - 230Vac 60Hz Models (only) Power cable which must be wired using a plug and socket, conductors colour coded as follows: Live 1 Black •... - Page 24 PCF Pro User Manual Water Supply Water Hardness <125ppm with water quality and purity tested and approved for Disinfection as per (CaCO ), Quality & Purity EN ISO15883-1:2009 (item 6.4.1 and 6.4.2) Pressure 2 – 5 bar (30 – 70 psi) for all water supplies Flow Rate 12 –...
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Page 25: Connecting The Pcf Pro
PCF Pro User Manual Connecting the PCF Pro Note: Medisafe (UK) Ltd. recommends this product be installed & commissioned by Medisafe (UK) Ltd (or suitably qualified personnel). Unpack the machine and position it within 14. Move the machine into its final position,... -
Page 26: Installation Drawings
PCF Pro User Manual Installation Drawings Rear View Showing Services DOC01851 Page 26 of 74... -
Page 27: Front View
PCF Pro User Manual Front View DOC01851 Page 27 of 74... -
Page 28: Left Side View With Lid Closed Showing Drain Connection
PCF Pro User Manual Left Side View with Lid Closed showing Drain Connection DOC01851 Page 28 of 74... -
Page 29: Left Side View Lid Open
PCF Pro User Manual Left Side View Lid Open DOC01851 Page 29 of 74... -
Page 30: Connecting To The Rs232 Port
PCF Pro User Manual Connecting to the RS232 Port Thermal Printer Data Logging PC 21. Identify the RS232 Data Cable Wash cycle data is sent from the serial port to a printer, however, as an alternative data may supplied, and plug the correct end... -
Page 31: Operation
3. Operation 3. Operation User Manual DOC01851 Page 31 of 74... -
Page 32: Menu
View and Edit Program Supervisor Menu Parameters Controls to raise and lower the Carrier Carrier Lift Note: When the PCF Pro has been idle for 10 minutes the screensaver will start, touch the display to exit. DOC01851 Page 32 of 74... -
Page 33: Power Up
PCF Pro User Manual Power Up Turn on the power to the machine using the Before the carrier lift system can be used, it isolation switch on the wall. must zero its position sensor. If the machine was powered off and the carrier lift was not... -
Page 34: Setting Time & Date
PCF Pro User Manual Setting Time & Date The time and date must be set correctly to ensure the accuracy of the cycle records, and MUST be periodically checked by the user. There is no automatic provision for daylight saving hours. While the machine is off, a backup battery maintains the time and date. -
Page 35: Selecting A Program
PCF Pro User Manual Selecting a program The PCF Pro is installed with six pre-programmed wash cycles during manufacture. When starting a cycle, the machine will use the currently selected program. To change the selected program, prior to initiating a cycle: 1. -
Page 36: Chemical Handling
PCF Pro User Manual Chemical Handling Users must read this section prior to any chemical handling. Detergents are caustic and can cause adverse effects to exposed tissues. Do not get in • eyes, on skin or attempt to ingest by mouth •... -
Page 37: Baskets
Basket Insertion Baskets To insert the basket, place it on the white The PCF Pro has three baskets, which are guide rails and push it back used to house DIN baskets. Easily placed into and removed from the machine, the baskets are held in racks on three levels and dock onto water supply spigots at the rear of the rack. -
Page 38: Luer Pipes
Luer connector Luer pipe Luer connector clip To remove the luer pipe, press the luer connector clip. Luer pipes The PCF Pro basket comes with luer pipe connections. Luer pipes are connected to these connections for cleaning of lumen instruments. DOC01851... -
Page 39: Instruments
Each basket is equipped with twenty ports for maximum pressure irrigation. These divided equally between each side to prevent crossovers or shadowing of instruments. When selecting Instruments for the PCF Pro: Always confirm compatibility with the • instrument manufacturer. • Always follow manufacturer’s... -
Page 40: Carrier Lift Controls
PCF Pro User Manual Carrier Lift Controls Safety Edge To protect the operator from crush injury a Use the scroll arrows to cycle through to Safety Edge pressure activated strip circles the carrier lift icon. the tank perimeter. Press and hold... -
Page 41: Testing Operation Of The Safety Devices
PCF Pro User Manual Testing Operation of the Safety Devices To check operation of the carrier lift: To check operation of the safety edge: 1. Press and hold to fully open the 1. While moving the carrier press the carrier lift and confirm the display... -
Page 42: Starting A Cycle
PCF Pro User Manual Starting a Cycle The load sequence is optimised for hands free Replace chemical(s) (see section 3- operation using the Load foot pedal to step 6-2) and press OK to continue, or through an automated sequence: press Cancel to abort the cycle start 3. -
Page 43: Automated Wash Cycle
PCF Pro User Manual Automated Wash Cycle The automated wash cycle consists of the stages Pre-wash, Wash, Rinse, Final Rinse/Disinfection, Cooling and Drying. Every stage of the cycle is configured by the Program Parameters stored in the machines memory (see section 3-5-1). These parameters allow the cycle to be customised to select the fill water type, skip stages, repeat stages, control temperature set points, set stage duration etc. -
Page 44: Pre-Wash
PCF Pro User Manual Pre-wash Wash All water in the tank is drained. The machine The tank is filled to the top level with a mix of fills with cold water to the minimum level. cold water attain During filling for each stage, the spray and temperature. -
Page 45: Rinse
PCF Pro User Manual to the minimum level. Once the tank is filled, the water heater will turn on to heat the water to the set point. Finally, all water in the tank is drained. Rinse The machine fills with hot water to the When the set point is reached, the machine minimum level. -
Page 46: Cooling
PCF Pro User Manual Cooling Unload On completion of the last cleaning stage, the The unload sequence is optimised for hands inside of the machine will be hot. To reduce free operation, where the Load foot pedal is the water vapour and temperature, cold water... -
Page 47: Re-Wash Cycle
PCF Pro User Manual Re-Wash Cycle Press Reload Complete on the screen to The PCF pro can be configured with a re-wash begin another wash stage program - a water and time saving feature. This allows the wash water and chemical to be reused. -
Page 48: Cycle Errors
If the error persists use another machine alternative Aborting a Cycle cleaning and disinfection process While running a cycle in the PCF Pro, it may (according to facility procedure), be necessary to end (abort) the cycle then contact a service engineer to operation before... -
Page 49: Led Edge
PCF Pro User Manual LED Edge Before Every Cycle 1. Visually check that there is enough The LED Edge colour status indicator on the chemical next wash. lid visually shows the current state of the Replenish as necessary. machine: 2. Clean the wash tank filter:... -
Page 50: Daily Checks
PCF Pro User Manual Check inside the spray arm and clear 6. Check condition basket any debris. irrigation port Luer hoses, ensure they are not kinked or ruptured. accordance ISO15883, international standard for the performance of Washer-Disinfectors, we advise the checks stipulated below. -
Page 51: Weekly Checks
PCF Pro User Manual 5. Check the 4 lid docking seals for any Weekly checks damage. 1. Carry out the daily checks. 2. Check water hardness of hot and cold water supplies. 3. Check water conductivity of final rinse water supply. -
Page 52: Decontamination Guide
3. Remove any trace of cleaner from In the unlikely event of a machine having to be internal and external surfaces with a returned to Medisafe for any reason, the clean wet cloth. following procedure must be carried out: 4. Towel dry. -
Page 53: Decontamination Certificate
PCF Pro User Manual Decontamination Certificate Ensure that all items returned to your supplier are disinfected in accordance 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. -
Page 54: Downloading The Cycle Log
Downloading the Cycle Log The PCF Pro contains on board memory, which holds a record of every cycle run on the machine. This Log can be downloaded to a USB flash drive via the USB Data port located in the chemical cabinet on the right hand side of the machine. -
Page 55: Troubleshooting
Troubleshooting 4. Troubleshooting User Manual DOC01851 Page 55 of 74... -
Page 56: Error Messages
PCF Pro User Manual This section of the manual describes the types of PCF Pro problems which may occur, and indicates probable causes/corrections. If the situation cannot be corrected following the Troubleshooting Solutions, repeating the cycle, or if a problem occurs which is not described, then please contact Medisafe. Service charges may be incurred, consult your warranty for details. - Page 57 PCF Pro User Manual Error Error Message Possible Causes and Solutions Code Check the Cold water temperature is not above 35°C Chamber Start Temperature too High The chamber has not cooled sufficiently since the last wash. Leave more time between washes for the machine to cool down.
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Page 58: Other Faults
Internal Circuit breaker has tripped, contact Medisafe • • The PCF Pro contains a manual override to allow the lid to be Access to the load in the opened, this must be carried out by trained service personnel. event of a power failure or Please contact Medisafe. -
Page 59: Technical
5. Technical 5. Technical User Manual DOC01851 Page 59 of 74... -
Page 60: General Specifications
PCF Pro User Manual General Specifications General Description Medical Device Class IIb Internal and external cleaning of surgical instruments, hollow-ware, and Intended Purpose associated products Operating Process Ultrasonic activity, Spray Arms and Irrigation Ports Class 1 electric shock protection, externally powered... - Page 61 PCF Pro User Manual Ultrasonics Typical Frequency 38 to 40 kHz dependant on load Transducers 84 piezo ceramic Power Pulsed Degas Auto-tune Features Frequency Sweep Reflectasonic Technology Electrical Supply Mains supply voltage fluctuations up to ±10% of the nominal voltage;...
- Page 62 PCF Pro User Manual Drainage System Type Gravity Drain Connection 54mm (2.125in) OD outlet Overflow Internally connected within the machine to the drain pipe, downstream of the drain valve Effluent Temp 95°C (203°F) Dimensions Wash Chamber Liquid Volume 165 Litres (43.5US gal)
- Page 63 PCF Pro User Manual Real Time Clock Battery Type CR1220 (5012LC) Typical Capacity 35 - 40 mAh Standard Discharge Current 0.1 mA Range and Accuracy Measurement range 2Cº to 98Cº (36ºF to 208ºF) Water Temperature Displayed and printed to the nearest ºC or ºF accuracy ±0.5ºC or ±0.9ºF Max water temperature: 95ºC (limited by software and thermal trip)
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Page 64: Applied Standards
PCF Pro User Manual Applied Standards Standard Description 2006/42/EC Machinery Directive Safety of machinery - Safety-related parts of control systems -- Part ISO 13849-1:2006 1: General principles for design Safety of machinery - Safety-related parts of control systems -- Part... -
Page 65: Appendices
6. Appendices 6. Appendices User Manual DOC01851 Page 65 of 74... -
Page 66: Emc
(including other medical devices). The purpose of this testing is to ensure that the PCF Pro 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 PCF Pro. -
Page 67: Electromagnetic Emissions
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The PCF Pro is intended for use in the electromagnetic environment specified below. The customer or the user of the PCF Pro should assure that it is used in such an environment. Emissions test... -
Page 68: Electromagnetic Immunity
Electromagnetic Immunity Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The PCF Pro is intended for use in the electromagnetic environment specified below. The customer or the user of the PCF Pro should assure that it is used in such an environment. - Page 69 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 PCF Pro is used exceeds the applicable RF compliance level above, the PCF Pro should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the PCF Pro.
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Page 70: Separation Distances Between Pcf Pro And Mobile Rf Equipment
RF communications equipment and the PCF Pro The PCF Pro is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the PCF Pro can help prevent... -
Page 71: Warranty
Owner’s Manual, misuse charge by Medisafe (UK) Ltd. or any distributor authorised of the new PCF Pro, use of the new PCF Pro under by Medisafe (UK) Ltd. to act as their agent (hereinafter unusual conditions, and modifications of or to the new called “authorised Medisafe dealer or distributor”). -
Page 72: Service Record
PCF Pro User Manual Service Record Medisafe recommend that your PCF Pro be serviced every 3 months in accordance with the schedule contained within the PCF Pro Service Manual, which also contains the technical description of the machine. This record must be completed by the engineer conducting the service and should be made available in the event of a warranty claim or breakdown repair. -
Page 73: Operator Pin Number Codes
PCF Pro User Manual Operator PIN Number Codes Operator # Operator # Operator # Operator # 2040 4060 6080 8020 2181 4121 6141 8161 2262 4282 6222 8242 2363 4383 6323 8343 2484 4424 6444 8464 2545 4565 6585 8525... -
Page 74: Symbols Glossary
PCF Pro User Manual Symbols Glossary Conformité Européenne: A conformity marking for certain products sold within the European Economic Area (EEA) since 1985. The CE marking is also found on products sold outside the EEA that are manufactured in, or designed to be sold in, the EEA.
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