SmartLine RotaScope G Series, Manual

Page 1: ...on Interlocking RFID door locks Airflow temperature pressure and humidity monitoring and reporting as per EN16442 Standards RFID Scope Data Monitoring and Display o Countdown timers for each scope o E...

Page 2: ...OPTIONS 10 Benefits of Shared Air System 11 Benefits of Vacuum Through Channels 14 CABINET SPECIFICATIONS 15 Cabinet Conditions 16 SpeCifications Table 18 OPERATION INSTRUCTIONS 23 Before Storage 24...

Page 3: ...Cable Distances 36 Closed Network tcp ip 36 Cabinet Reset Button 37 Printing Labels 38 INSTALLATION REQUIREMENTS 39 Information to Gather 40 Room Layouts Ceiling Heights and Wall Construction 40 Bulkh...

Page 4: ...net 51 Maintenance Contracts 52 PQ Performance Qualification 52 Compliance 53 TROUBLESHOOTING 54 PHYSICAL TESTS AND CHECKS 56 Air Flow Check 56 Endoscope Condition 56 Power Outages 56 ANNEX A VALIDATE...

Page 5: ...MAN 0901 RotaScope VALID DATE 01 2019 to 12 2020 Model RotaScope G Upgrades 5 Copyright Smartline Medical Pty Ltd All rights reserved Sterilising for Sterile Storage 69...

Page 6: ...rranty of any kind with regard to this manual including but not limited to the implied warranties of merchantability non infringement and fitness for a particular purpose Smartline Machinery shall not...

Page 7: ...NTS Continuous monitored air drying cabinets complying with European Standard EN 16442 2015 for drying Thermoliable Endoscopes Globally this standard currently represents the highest documented level...

Page 8: ...VALID DATE 01 2019 to 12 2020 Model RotaScope G Upgrades 8 Copyright Smartline Medical Pty Ltd All rights reserved RotaScope CABINET OVERVIEW Acrylic Side Panels white standard Clean Spot inside door...

Page 9: ...onsite the client will incur additional charges if changes were not requested in the original specification Right Hand Hinged Standard Left Hand Hinged upon request Right Hand Hinged Standard Left Ha...

Page 10: ...MAN 0901 RotaScope VALID DATE 01 2019 to 12 2020 Model RotaScope G Upgrades 10 Copyright Smartline Medical Pty Ltd All rights reserved RotaScope AIR OPTIONS...

Page 11: ...aScope G Upgrades 11 Copyright Smartline Medical Pty Ltd All rights reserved BENEFITS OF SHARED AIR SYSTEM The cabinet will provide an environment fit for drying qualified scopes stored inside Air flo...

Page 12: ...service 1 7 cabinets and will require air ducting from the pump system Remote Air Generator to the cabinets The largest pump will require a 3 Phase power source 2 Shared Air Box The Shared Air Box ca...

Page 13: ...rved Single cabinet install schematic Double cabinet install schematic The Shared Air Box 09 SAB will generate HEPA Filtered air and vacuum for up to two cabinets The Shared Air Box is located with th...

Page 14: ...x 3x 5 1x 1x 2x 2x 3x 1 N A N A N A N A N A 2 1x 1x 2x 2x 3x Pumps 3 N A N A N A N A N A 4 1x 1x 2x 2x 3x 5 N A N A N A N A N A BENEFITS OF VACUUM THROUGH CHANNELS The RotaScope Cabinet uses vacuum wh...

Page 15: ...MAN 0901 RotaScope VALID DATE 01 2019 to 12 2020 Model RotaScope G Upgrades 15 Copyright Smartline Medical Pty Ltd All rights reserved RotaScope CABINET SPECIFICATIONS...

Page 16: ...emp Routine Cleaning Status Clean Due CONTROL SAB and Alarm Status Scope Location Button Detailed Storage Info The air system automatically maintains a positive pressure within each cabinet Having a p...

Page 17: ...tline Medical Pty Ltd All rights reserved Cabinet lighting will change colour each fault has an assigned colour see Warnings and Alarms section Cabinet Mounted Touch Screen Control Screen Sensor Statu...

Page 18: ...omated channel flushing control N A Automated channel flushing NOT used Air Flow circulation diagram See USER Manuals See Benefits of Shared Air System RotaScope Page 10 SlidaScope Page 10 Cabinet Flo...

Page 19: ...Failure Testing carried out as part of Annual PQ in accordance with AS4187 and EN16442 Preventative Maintenance See Service Agreement and or User Manual See PQ Performance Qualification RotaScope Page...

Page 20: ...abinet will return to green and OoC will cease counting down Clean Alarm 24hr Warning Blue Light Alarm Subtracts time from OoC Requires Cabinet Clean Function to rectify alarm Storage Expiry Instant V...

Page 21: ...ed Timber SHARED AIR BOX Shared Air Box Dimensions Height x Width x Depth 334 x 600 x 500mm Power USA Power Other regions 110V 60Hz 20A Cabinet 240V 50Hz 10A Actual 3 1A 240V Data 12V SAB Product Weig...

Page 22: ...al Pty Ltd All rights reserved ISO 9001 Quality Assurance 2018 Audited and current TGA approval article number ARTG 140018 Current 2018 RotaScope with Shared Air Box fitted on top Dimensions 600mm W x...

Page 23: ...MAN 0901 RotaScope VALID DATE 01 2019 to 12 2020 Model RotaScope G Upgrades 23 Copyright Smartline Medical Pty Ltd All rights reserved RotaScope OPERATION INSTRUCTIONS...

Page 24: ...ill announce Scope Stored 6 The RotaScope Cabinet centre post assembly can be rotated in either direction to expose vacant hooks to the most convenient position for hanging or removing scopes 7 Pick u...

Page 25: ...NTRE DISC HEIGHTS If the standard working height of the top or centre disc does not suit the following steps will detail how to adjust this 1 Remove all endoscopes from the cabinet 2 Use the supplied...

Page 26: ...ternal surfaces of the scope will need to be purged and blown off using medical grade air to remove excessive moisture prior to loading into the cabinet for continuous drying Extra attention must be p...

Page 27: ...m temperatures for sterilization of channel separator O Rings is 40 to 125 C Washing the O Rings for prolonged periods over 115 C may cause them to swell leading to damage to the surface that makes co...

Page 28: ...MAN 0901 RotaScope VALID DATE 01 2019 to 12 2020 Model RotaScope G Upgrades 28 Copyright Smartline Medical Pty Ltd All rights reserved RotaScope DATA SYSTEM...

Page 29: ...ce Tag Washer Information o WHO Operator that washed the scope in the AER o WHAT Which Scope o WHERE Where it was washed Washer AER Chamber Into the AER Out of the AER Storage Information o WHO Operat...

Page 30: ...SCOPE TAG FITS ONTO UMBILICAL CORD STAFF TAG USE ON KEY FOB SCOPE MANAGER The Scope Manager Software is used to link RFID Tag Information to the Data System This unit runs off USB and with a PC and s...

Page 31: ...1 2019 to 12 2020 Model RotaScope G Upgrades 31 Copyright Smartline Medical Pty Ltd All rights reserved BELOW Scope Manager Software Used to easily create Scope Tags Loan Scope Tags or Operator Tags W...

Page 32: ...ghts reserved SEQUENCE FOR WASHING SCOPE WHO WHAT WHERE WHO Who Initiated the wash cycle WHAT What Which scope WHERE ADDING AND REMOVING SCOPES FROM THE CABINET WHO Who Unlocked the door and is storin...

Page 33: ...MAN 0901 RotaScope VALID DATE 01 2019 to 12 2020 Model RotaScope G Upgrades 33 Copyright Smartline Medical Pty Ltd All rights reserved Present Scope Tag to Printer Printed Label REPLACING LABELS...

Page 34: ...r 1 1 gigahertz GHz 64 bit dual core processor Operating System Windows 10 Display 1366 x 768p Memory RAM 4 gigabyte GB RAM 64 bit Auxiliary parts Tag reader Loan Scope tags Wireless mini USB adaptor...

Page 35: ...LAPTOP The laptop s desktop background Scope Manager Installed onto Laptop For setting up RFID tags Complete executable installer file Tag Reader Supplied with Laptop Kit For reading tags and using wi...

Page 36: ...and will result in a seamless and easy installation CLOSED NETWORK TCP IP The Data System runs on an independent LAN Local Area Network separate from the hospitals own data network This closed system...

Page 37: ...MAN 0901 RotaScope VALID DATE 01 2019 to 12 2020 Model RotaScope G Upgrades 37 Copyright Smartline Medical Pty Ltd All rights reserved CABINET RESET BUTTON...

Page 38: ...rom cabinet using Who What Where sequence and present Scope Tag to Printer Station Wand Along with After Clean To print this record Once scope is removed from AER this label prints Incorrect Scope Rem...

Page 39: ...MAN 0901 RotaScope VALID DATE 01 2019 to 12 2020 Model RotaScope G Upgrades 39 Copyright Smartline Medical Pty Ltd All rights reserved RotaScope INSTALLATION REQUIREMENTS...

Page 40: ...there is a range of things to consider and clarify with the customer Refer to form F227 for required information ROOM LAYOUTS CEILING HEIGHTS AND WALL CONSTRUCTION The cabinets and components can be...

Page 41: ...MAN 0901 RotaScope VALID DATE 01 2019 to 12 2020 Model RotaScope G Upgrades 41 Copyright Smartline Medical Pty Ltd All rights reserved Front View Opening and Power Data Points Example...

Page 42: ...reserved BULKHEAD If the ceiling height is 2700mm and there is no SAB mounted on top of the cabinet a bulkhead should be added to the job The hospital builder can arrange to have a bulkhead built ons...

Page 43: ...at least 2500mm in any one direction and if not it will have to be confirmed that the stairwell is an acceptable alternative route INSTALL DATES WORK HOURS On occasion capital equipment installation...

Page 44: ...MAN 0901 RotaScope VALID DATE 01 2019 to 12 2020 Model RotaScope G Upgrades 44 Copyright Smartline Medical Pty Ltd All rights reserved RotaScope STAFF TRAINING AND EDUCATION...

Page 45: ...cover some steps that are not required for every installation The typical endoscope workflow is as follows 1 End of procedure bedside wipe down 2 Manual wash and leak test 3 Scan Scope into AER washe...

Page 46: ...itively pressured cabinet external air cleaning room theatre will not flow into the cabinet All the Environmental Conditions are measured and recorded by the Data Management System as required to meet...

Page 47: ...and or for contractors in service training may need to be carried out in two stages Stage 1 Before handover and to the nominated parties of the contractors Stage 2 After site handover and to the opera...

Page 48: ...20 Model RotaScope G Upgrades 48 Copyright Smartline Medical Pty Ltd All rights reserved RotaScope MAINTENANCE AND CLEANING Follow these cleaning processes to ensure a decontaminated environment befor...

Page 49: ...Do not allow electrical or electronic components where fitted to become wet or splashed with water or other fluids Any fluids issuing from recently attached scopes should immediately be wiped up INTER...

Page 50: ...eaned within 24 hours of the Blue light reminder It is also acceptable to clean before the scheduled day Once cabinet is cleaned operator should validate the clean by scanning USER tag then CLEAN spot...

Page 51: ...n either direction o Inspect that each occupied scope hook has no more than one scope attached Inspect the silicone connection hoses luer fittings for wear tear or damage Are the silicone connection h...

Page 52: ...ordance with the applicable national or international standards PQ shall be performed a Immediately after IQ and OQ for newly installed or relocated equipment b When repairs are made or a service is c...

Page 53: ...2020 Model RotaScope G Upgrades 53 Copyright Smartline Medical Pty Ltd All rights reserved COMPLIANCE A sample compliance sticker has been shown below Please refer to your individual product for the c...

Page 54: ...MAN 0901 RotaScope VALID DATE 01 2019 to 12 2020 Model RotaScope G Upgrades 54 Copyright Smartline Medical Pty Ltd All rights reserved RotaScope TROUBLESHOOTING...

Page 55: ...MAN 0901 RotaScope VALID DATE 01 2019 to 12 2020 Model RotaScope G Upgrades 55 Copyright Smartline Medical Pty Ltd All rights reserved...

Page 56: ...s In the case where the endoscope is cleaned and disinfected using a validated processing procedure washers compliant with EN ISO 15883 4 2009 this verification is included through channel monitoring...

Page 57: ...MAN 0901 RotaScope VALID DATE 01 2019 to 12 2020 Model RotaScope G Upgrades 57 Copyright Smartline Medical Pty Ltd All rights reserved RotaScope ANNEX A VALIDATED SCOPES FOR STORAGE...

Page 58: ...nd Series Type CF H260AZI158 Olympus Colonoscope CF H260AZL158 Olympus Colonoscope CF 240AI49 Olympus Colonoscope CF 240AL49 Olympus Colonoscope CF H180DI293 Olympus Colonoscope CF H180DL293 Olympus C...

Page 59: ...0ZL Olympus Colonoscope CF 200HL Olympus Colonoscope CF 200S49 Olympus Colonoscope CF 240DI156 Olympus Colonoscope CF 240DL156 Olympus Colonoscope CF 240I49 Olympus Colonoscope CF 240L49 Olympus Colon...

Page 60: ...CF Q240ZL49 Olympus Colonoscope CF Q260AL Olympus Colonoscope CF Q260DI158 Olympus Colonoscope CF Q260DL158 Olympus Colonoscope CF V70I183 184 Olympus Colonoscope CF V70L183 184 Olympus Colonoscope CF...

Page 61: ...Gastro GF UE160 AL5 Olympus Gastro GF UMQ240 Olympus Gastro GF UM2000 Olympus Gastro GIF 100 Olympus Gastro GIF 130 Olympus Gastro GIF 14038 105 Olympus Gastro GIF 145 Olympus Gastro GIF 160 Olympus G...

Page 62: ...Gastro GIF Q160 Olympus Gastro GIF Q160Z Olympus Gastro GIF Q165 Olympus Gastro GIF Q180 Olympus Gastro GIF Q200155 Olympus Gastro GIF Q2031 98 Olympus Gastro GIF Q260158 Olympus Gastro GIF Q260J293 O...

Page 63: ...T40 Olympus Duodeno JF 240 Olympus Duodeno OLYMPUS BRONCHOSCOPES Name Brand Series Type BF 30 Olympus Bronco BF 40 Olympus Bronco BF 140 Olympus Bronco BF 160 Olympus Bronco BF 180 Olympus Bronco BF 2...

Page 64: ...onco BF XT30 Olympus Bronco BF F260 Olympus Bronco BF H190 Olympus Bronco BF XP190 Olympus Bronco BF 1TH190 Olympus Bronco BF P260F Olympus Bronco ENF VT Olympus Bronco ENF VT2 Olympus Bronco LTF 160...

Page 65: ...oscope EC 3870FK Pentax 70K Colonoscope EC 3870MK169 Pentax 70K Colonoscope EC 3870FZK Pentax 70K Colonoscope EC 3880FK Pentax 80K Colonoscope EC 3880FK2 Pentax 80K Colonoscope EC 3880MK169 Pentax 80K...

Page 66: ...C 530MT293 Fujinon 530 Colonoscope EC 530WM Fujinon 530 Colonoscope EC 530WTM263 Fujinon 530 Colonoscope EC 590WM Fujinon 590 Colonoscope EC 590ZW M Fujinon 590 Colonoscope EC 250DM5 Fujinon 250 Colon...

Page 67: ...low system High level disinfection of each hose connector should be undertaken weekly during the cabinet cleaning cycle Cleaning may be Manual or Automated and can also be autoclaved to gain shelf lif...

Page 68: ...en flush out Repeat a minimum of two more times do not flush out on last action 9 Achieve contact time with hoses submerged for the appropriate timeframe outlined in the chosen cleaning solution IFU 1...

Page 69: ...oses from the Washer Rack Hose Connection Kit 6 Hang hoses back inside endoscope cabinet connected to forced air for additional drying STERILISING FOR STERILE STORAGE RECOMMENDED STEPS After Manual or...