Medisafe SI PCF Скачать руководство пользователя страница 70

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Technical

SI PCF User Manual

Ref: DOC03148 Issue 1 Friday, 06 January 2017

Page 70 of 81

Applied Standards

Standard

Description

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

UL 61010-1-2nd Edition

Safety Requirements for Electrical Equipment for Measurement,

Control, and Laboratory Use

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 SI PCF

Страница 1: ...SI PCF User Manual...

Страница 2: ...Ref DOC03148 Issue 1 Friday 06 January 2017 Page 2 of 81 Intentionally blank...

Страница 3: ...ntamination 19 Heat 19 Electrical Safety 19 Service Contracts Warranty 19 Validation Option 19 2 INSTALLATION 21 Transport and Storage 22 Marking 22 Environmental 22 Lifting 22 Unpacking 22 Returns 22...

Страница 4: ...rtion 44 Instruments 44 Instrument Loading Precautions 44 Starting a Standard Instrument Cycle 45 Starting a Robotic Instrument Cycle 46 Manual Pre Wash 46 Instrument Loading 46 Automated Wash Cycle 4...

Страница 5: ...5 TECHNICAL 65 General Specifications 66 Applied Standards 70 6 APPENDICES 71 EMC 72 EMC Electromagnetic Compatibility Data 72 Electromagnetic Emissions 73 Electromagnetic Immunity 74 Separation Dist...

Страница 6: ...Table of Contents SI PCF User Manual Ref DOC03148 Issue 1 Friday 06 January 2017 Page 6 of 81 Intentionally blank...

Страница 7: ...Ref DOC03148 Issue 1 Friday 06 January 2017 Page 7 of 81 1 Introduction 1 Introduction User Manual...

Страница 8: ...ct 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...

Страница 9: ...of this equipment must carefully review and comply with the warnings cautions and instructions contained in this manual These instructions are important to protect the health and safety of personnel...

Страница 10: ...n and witnessed by the owner of the product For installation instructions and contact information for qualified personnel who can perform the installation please contact Medisafe see section 1 1 Failu...

Страница 11: ...ributor to validate the warranty Tests parts one and two must be completed by the engineer commissioning the SI PCF for warranty registration purposes Where no value is required write pass or fail wit...

Страница 12: ...rature 5 C 41 F min 30 C 86 F max Hot Water Pressure 2 5 bar 30 70 psi Cold Water Pressure 2 5 bar 30 70 psi Part 2 Final rinse water Acceptable Value Result Comments Rinse water supply Type RO DI Sof...

Страница 13: ...ndling chemical refilling chemical containers or servicing chemical injection pumps and lines Wear appropriate Personal Protective Equipment PPE whenever handling chemicals or servicing chemical injec...

Страница 14: ...serious injury Warning Slipping Hazard To avoid slippery floor conditions immediately wipe up any spilled liquid or condensation If spills or leaks could contain detergents or other chemicals follow s...

Страница 15: ...o controls Caution Chemical Caution Chemical bottles must be connected to the correct port Otherwise wash efficiency and or rinsing will be compromised Check chemical bottles are in date before use Ca...

Страница 16: ...nce 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 3 10 and 3 11 Safe use of machine see section 1 5 Chemical handing se...

Страница 17: ...s that the appropriate 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 WEE...

Страница 18: ...to perform within strict and carefully controlled tolerances If an unexpected condition occurs during a wash cycle the system will abort the cycle and report an error see section 3 12 for more details...

Страница 19: ...ll times Refer servicing and repair to qualified personnel only It is expected that any person servicing or repairing the SI PCF will be a competent engineer with an understanding of electrical safety...

Страница 20: ...Introduction SI PCF User Manual Ref DOC03148 Issue 1 Friday 06 January 2017 Page 20 of 81 Intentionally blank...

Страница 21: ...Ref DOC03148 Issue 1 Friday 06 January 2017 Page 21 of 81 2 Installation 2 Installation User Manual...

Страница 22: ...n excess of 250kg Unpacking Retain all packaging materials if for any reason the unit needs to be returned to the supplier then the original crate and packaging materials should be re used Carefully u...

Страница 23: ...CF variant are shown in the tables below Replacement 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 S...

Страница 24: ...1 MET129 Water Heater Spanner 3 HOSE007 Water Inlet Stainless Steel Hose Red Indicator 1 HOSE010 Overflow Hose clear PVC reinforced 50mm I D 1 MED3020 Drain Hose 2 5m 1 MED8558 Jubilee Clip 50 70mm 1...

Страница 25: ...your guarantee of performance Baskets Part No Description MED8601 Standard Basket MP21833 Si Robotic Basket Including Hose Luers MP21104 Xi Robotic Basket Including Hose Luers Printer Part No Descript...

Страница 26: ...Grey Neutral Blue Earth Green Yellow Live 1 Black Live 2 Black Live 3 Black Earth Green Yellow Live Brown Neutral Blue Earth Green Yellow The cable must be protected with a 3phase Residual Current De...

Страница 27: ...il outlet from machine Drain must fitted with suitable traps No Loops in the drain hose cut the hose to required length Position Drain entry and the entire drain hose must less than 500mm 20in above g...

Страница 28: ...lower rear of the unit 4 Secure the drain hose to the machine using the supplied jubilee clip 5 Connect the large end of the drain hose to the site drain cutting to length as required 6 Identify a st...

Страница 29: ...Installation SI PCF User Manual Ref DOC03148 Issue 1 Friday 06 January 2017 Page 29 of 81 Installation Drawings Front View...

Страница 30: ...Installation SI PCF User Manual Ref DOC03148 Issue 1 Friday 06 January 2017 Page 30 of 81 Rear View Showing Services PREFERRED...

Страница 31: ...Installation SI PCF User Manual Ref DOC03148 Issue 1 Friday 06 January 2017 Page 31 of 81 Right Side View Lid Closed PREFERRED...

Страница 32: ...Installation SI PCF User Manual Ref DOC03148 Issue 1 Friday 06 January 2017 Page 32 of 81 Right Side View Lid Open PREFERRED...

Страница 33: ...Installation SI PCF User Manual Ref DOC03148 Issue 1 Friday 06 January 2017 Page 33 of 81 Rear View Alternative Drain Connection...

Страница 34: ...Installation SI PCF User Manual Ref DOC03148 Issue 1 Friday 06 January 2017 Page 34 of 81 Right Side View Alternative Drain Connection...

Страница 35: ...ess the online button 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 th...

Страница 36: ...Installation SI PCF User Manual Ref DOC03148 Issue 1 Friday 06 January 2017 Page 36 of 81 Intentionally blank...

Страница 37: ...Ref DOC03148 Issue 1 Friday 06 January 2017 Page 37 of 81 3 Operation 3 Operation User Manual...

Страница 38: ...utomated cycle sequence Wash Program Set the selected 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...

Страница 39: ...valid PIN entry identifies the user and their operator number is shown on the cycle printout There are 80 operator numbers each with a unique PIN number see Appendix 6 8 for details Setting Time Date...

Страница 40: ...he and buttons Standard Program Parameters Parameters Units Program Number Standard Wash Cycle Re Wash Cycle Heavy Wash Cycle Standard Disinfect Cycle Heavy Disinfect Cycle Intense Disinfect Cycle P1...

Страница 41: ...a Vinci Disinfect Cycle P1 P2 P3 P4 P5 P6 Pre wash Time Minutes 3 0 3 3 3 3 Wash Chemical 1 ml 360 360 360 360 360 360 Wash Temperature C 40 40 40 40 40 40 Degas Minutes 3 3 3 3 3 3 Wash Time Minutes...

Страница 42: ...ate Personal Protective Equipment PPE whenever handling chemicals or servicing chemical injection pumps and lines This should include plastic gloves goggles or full face visor and disposable plastic a...

Страница 43: ...p tube connect to the right hand socket and port Chemical bottles must be connected to the correct port Otherwise wash efficiency and or rinsing will be compromised Disposal of chemical containers For...

Страница 44: ...ng instruments with special characteristics e g fibre optics or rigid optics Whether pre or post processing instruments Always follow the manufacturer s instructions Instrument Loading Precautions Whe...

Страница 45: ...e basket from the machine 6 Load instruments into the basket 7 Insert the basket into the machine 8 Lower the basket into the machine pushing down on the handles 9 Ensure the basket is locked into pos...

Страница 46: ...ee section 3 5 2 Press Load Instruments 3 If there is insufficient chemical to complete the cycle a warning will be shown Replace chemical s see section 3 6 1 and press OK to continue or press Cancel...

Страница 47: ...hing it down until the side latches engage on both sides of the tank 11 Press Start to confirm instrument loading complete 12 Close the lid and firmly push down on the handle to engage the lock and th...

Страница 48: ...ating through the lumens and lid spray Degas Pulse ultrasonics on and off for the degas period with no recirculation Cycling Alternate between ultrasonics 45s and lumen flushing 15s for a set period D...

Страница 49: ...water in the tank is 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 di...

Страница 50: ...t point When the set point is reached the machine will alternate between Flushing and Spraying for a pre defined time Finally all water in the tank is drained Final Rinse Disinfection The machine fill...

Страница 51: ...e latch then lift from the machine Press OK on the screen to confirm unloading complete If any instruments became detached from the Medisafe connection tubing during processing they should be reproces...

Страница 52: ...imes Note if the water temperature exceeds the set point by more than 10 C the cycle will be aborted see section 3 12 At the end of a wash stage press Yes on the screen to reuse the water again Unload...

Страница 53: ...ocedure then contact a service engineer to repair the machine If an error occurs An audible alarm will sound An error code and description will be shown on the display The printer will output the Erro...

Страница 54: ...ws to cycle through to 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 downl...

Страница 55: ...Isopropyl Alcohol or a household kitchen cleaner can be used provided it is marked as a DISINFECTANT cleaner In the interests of health and safety all medical washers should be cleaned on a weekly bas...

Страница 56: ...is sufficient chemical for the days planned use 3 Check and clean all internal surfaces above the water line 4 Check and clean all external surfaces including lid seal 5 Check mains power cord is not...

Страница 57: ...cleaning disinfection cycle 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...

Страница 58: ...e 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 th...

Страница 59: ...Ref DOC03148 Issue 1 Friday 06 January 2017 Page 59 of 81 4 Troubleshooting 4 Troubleshooting User Manual...

Страница 60: ...er A copy of the printout 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...

Страница 61: ...ed Check for leaks 23 Temperature Set Point Exceeded Repeat cycle 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...

Страница 62: ...basket and not pointing up at the lid Check lid seal is undamaged Excessive Fill Time Check incoming water pressure is above 2 bar 29 psi Check water inlet valve is not blocked beware of hot water te...

Страница 63: ...e the lid lock The lid lock override socket is on the top left of the machines lid Insert the key into the lid lock socket and turn anticlockwise to override the lock to allow the lid to be opened as...

Страница 64: ...Troubleshooting SI PCF User Manual Ref DOC03148 Issue 1 Friday 06 January 2017 Page 64 of 81 Intentionally blank...

Страница 65: ...Ref DOC03148 Issue 1 Friday 06 January 2017 Page 65 of 81 5 Technical 5 Technical User Manual...

Страница 66: ...ten ports open each basket manifold outputs produces up to 3 bar 43 5psi pressure with a flow rate of 50ml s Basket Connection Drop and Lock for easy irrigation connection User Interface Display TFT...

Страница 67: ...ge 200 230VAC 3P PE Three Phase Protective Earth Frequency 50Hz Power 10kW Site Current Capacity 24A per phase Site MCB and Disconnect Switch Current Rating 32A Site Wiring Cross sectional area 6mm2 M...

Страница 68: ...ll vary depending on the cycle selected and the site facilities Weight Operational weight Dry 150kg 331lb Shipping weight 217kg 479lb Drainage System Type Pumped Drain Connection 19mm in hose tail out...

Страница 69: ...midity 80 for temperatures up to 31 C 87 8 F decreasing linearly to 50 relative humidity at 40 C 104 F Noise Max SPL 68dBA 1m from the front of the machine Real Time Clock Battery Type CR1220 5012LC T...

Страница 70: ...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...

Страница 71: ...Ref DOC03148 Issue 1 Friday 06 January 2017 Page 71 of 81 6 Appendices 6 Appendices User Manual...

Страница 72: ...tion as supplied The SI PCF may be supplied with the following accessories serial data cable MED1017 and thermal printer MED1014 1 The SI PCF s data cable must be restricted to less than 3m in length...

Страница 73: ...ctromagnetic environment guidance RF emissions CISPR 11 Group 1 The SI PCF uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interfe...

Страница 74: ...de 2 kV common mode Mains 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 1...

Страница 75: ...stance in metres m Fields 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 In...

Страница 76: ...ions equipment Rated 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...

Страница 77: ...es LEDs 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 SI P...

Страница 78: ...h Serviced by Date Serviced 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 servic...

Страница 79: ...5 4424 45 6444 65 8464 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 70...

Страница 80: ...Appendices SI PCF User Manual Ref DOC03148 Issue 1 Friday 06 January 2017 Page 80 of 81 Intentionally blank...

Страница 81: ...ld 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 UL Underwriters Laboratories An American worldwide...

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