SmartLine Medical ROTA-IQ Installation And User Instructions Manual Download Page 1

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RotaScope iQ Cabinet

Manual Version

1.04

Date

23 November 2021

Installation and User Instructions

RotaScope iQ Series

Endoscope Drying Cabinet

Summary of Contents for ROTA-IQ

Page 1: ...RotaScope iQ Cabinet Manual Version 1 04 Date 23 November 2021 1 Installation and User Instructions RotaScope iQ Series Endoscope Drying Cabinet...

Page 2: ...improvements or amendments or have found errors in this publication please notify us All pertinent state regional and local safety regulations must be observed when installing and using this product F...

Page 3: ...ormation about company names products and services mentioned in this manual Trademarks shown below were derived from various sources All trademarks are the property of their respective owners General...

Page 4: ...4 2 5 Product Compliance 14 2 5 1Compliance Labels 14 2 6 Product elements 17 2 6 1RotaScope Cabinet Components 17 2 6 2IAS Components 18 2 6 3System Connection Overview 19 2 6 4Internal Cabinet Compo...

Page 5: ...ety information related to the intended use and reasonably foreseeable misuse 49 3 1 5 Personal Protective Equipment 50 3 1 6 Product limitations and restrictions 50 3 1 7 Maintenance safety informati...

Page 6: ...4 2 9 Data and Power Schematic 82 4 2 10 Required Tools 83 4 3 How to Commission the Product 83 4 3 1 Installation of the software 83 4 3 2 Calibration of the device 83 5 OPERATION USE Verification 84...

Page 7: ...mble the Product 89 8 2 How to Recycle Parts 90 8 3 How to Dispose the Product 90 8 3 1 Test procedure to facilitate safe disposal of the device and related waste substances 90 8 3 2 Disposal of the d...

Page 8: ...and its approved accessories and or performs the unloading loading of the Endoscopes in the RotaScope The User must not tamper or modify the RotaScope Any modifications servicing or repairs must be do...

Page 9: ...istributor Only Approved Distributors may install service or repair Smartline Medical equipment Avoid contact of electrical components with water and moisture Do not connect to any external electronic...

Page 10: ...he manufacturer is not liable for cases of material damage or personal injury caused by incorrect handling or non compliance with the safety instructions In such cases the warranty will be voided 1 4...

Page 11: ...manufacturer The following natural or legal person makes the device to which this user manual applies suitable for use within the European Union and is considered to be the manufacturer of the device...

Page 12: ...ed Endoscope Hose Connection Kits Purchased Separately It is essential that the user of this manual is aware of the potential hazards associated with the unit and its accessories All operators should...

Page 13: ...reduce reprocessing costs and deliver operational efficiency and save time and costs Out of the Cabinet 2 3 Minimum System Requirements Computer and Processor 1 1 gigahertz GHz 64 bit dual core proce...

Page 14: ...ls RotaScope Cabinet Compliance Label affixed at top front of cabinet behind the fa ade Parameter Unit Device name RotaScope iQ Series Designation Class 1 Type Endoscope Storage Cabinet UNSPC Commodit...

Page 15: ...Label is fitted to the side of the SmartStation see labels below 2 5 1 1 RotaScope Cabinet Product Compliance Label Located at the top front of the Cabinet behind the fa ade 2 5 1 2 Integrated Air Sys...

Page 16: ...RotaScope iQ Cabinet Manual Version 1 04 Date 23 November 2021 16 Located on the side of the SmartStation mounting enclosure...

Page 17: ...21 17 2 6 Product elements 2 6 1 RotaScope Cabinet Components The Cabinet may be configured with a Rear Door if it is the Pass Through version The Cabinet may also include an X Ray Kit on the rear doo...

Page 18: ...vices The 4 POE ethernet ports located on the right side are for connecting Ethernet cables CAT 6 from the cabinet to other cabinets and for connecting SmartStation units A router device may also be c...

Page 19: ...AS Integrated Air System The connecting Ethernet cables may be linked directly as drawn or via Point to Point wall sockets as specific to your site design please confirm your site specific layout deta...

Page 20: ...opes and easy to clean Hang Hooks may be adjusted high or low for Long or Short Scopes and easy access The Centre Pole can be manually rotated for scope selection The Vacuum Manifold above left is the...

Page 21: ...to suit your scopes Various ENT Hooks are available and an Authorised Distributor will assist you with ordering special needs hang hooks will hold most types of flexible scopes A mix of ENT and Stand...

Page 22: ...Manifold Details RotaScope Centre Pole OVERVIEW The Top Disk of the centre pole The hang hooks may be selected to suit various types and lengths of scopes Please see your Authorised Distributor for as...

Page 23: ...ese tubes need to be dried after a scope is washed to prevent any tiny remnants of biofilm or free radical bugs from proliferating After reprocessing in simple terms A dry scope is a good scope For ea...

Page 24: ...n independently approved storage time of 31 Days in the cabinet Complies with European Dying Cabinet Standard EN16442 2015 Digital data capture Stored in an SQL Database The cabinets are controlled by...

Page 25: ...coloured stickers on manifold Close door door locks Audio Prompt SCOPE LOADED POSITION X See Main Screen for location and status of loaded scope Cabinet Environment details can also be seen Main Scree...

Page 26: ...cept of drawing air through the scope via vacuum instead of blowing air through the scope channels for drying Elevated temperature and Vacuum in theory can assist in drying faster By using vacuum infe...

Page 27: ...om with constant air conditioning at 22 degrees C maximum 38 degrees C Recommended Room Humidity 90 Cabinet Internal Operating Temperature 22 45 Degrees C Usually 30 37 Cabinet internal pressure appro...

Page 28: ...te to further Detail Screens by touching the section that you want further information about e g Control Panel Cabinet Control Screen The Cabinet Control Screen is located on the front cabinet door an...

Page 29: ...button to the detail screen Press the relevant Icon see below Coloured icons indicate status E g RED colour indicates Over temperature CHECK CABINET Press to go to detail screen Scope status is indica...

Page 30: ...L NO e g 00000001005 WASH TIME e g 14 24 22 July 2021 Time and Date WASHED BY e g Ben Morris Who Unloaded AER Washer MAX STORAGE HRS e g 744 Storage Duration from AER unload STORED BY e g SARAH Jones...

Page 31: ...em ON OFF LOCK CABINET Press to Lock the cabinet Use Operator ID Barcode Tag to scan to Unlock HELP Press for further help REMOVE ALL SCOPES FOR CLEANING Press to remove all scopes for weekly cabinet...

Page 32: ...gs from environmental sensors The MIN Minimum and MAX Maximum values where applicable are displayed to the right 2 10 Visual Signals at Cabinet Cabinet Environmental Lighting changes with status and e...

Page 33: ...ER i e Clean Door Control Screen Voice 3 Cabinet Cleaning Scan Operator ID Barcode Staff ID Badge Audio Tone Operator then press Cabinet Clean Button on Main Screen Audio Tone Cleaned Used when cleani...

Page 34: ...e Status Various information is available by navigating through touch activated screens Cabinet Control Screen Screen Display Cabinet Clean Due Date Located on Cabinet Control Main Screen Clean Due Da...

Page 35: ...anual Version 1 04 Date 23 November 2021 35 2 11 3 Labels at SmartStation Print Station See labels below Wash Label Cabinet Clean Record Storage Label Power Outage Record Incorrect Scope Removal Envir...

Page 36: ...to deliver system warnings and various printed stickers for different reported functions The SmartStation is used to AER Load Unload AER Scan Operator Barcode Scope Barcode AER Chamber Barcode to load...

Page 37: ...n Touchscreen Display The Touch Screen display shows the station and application details and may be set up differently depending on the configuration of your site This intuitive device with Touch Scre...

Page 38: ...ions for use IFU and in an Approved Endoscope Reprocessing Cycle as per the hospital guidelines in your region AER Chamber Barcode Labels are used to identify each AER Washer and each Washer Chamber a...

Page 39: ...ICKER is located on the Endoscope Handpiece as indicated in this diagram The Barcode should be easily visible so that scanning process can occur The Barcode Sticker has no effect on the use or deconta...

Page 40: ...ct to scan either LONG STORAGE or SHORT STORAGE Time Barcode when Unloading the AER NOTE If Long Storage is required most usual then this step may be omitted i e Use only steps 1 2 4 see notes about L...

Page 41: ...T When scanning a scope OUT of a washer a digital record identifies who unloaded the scope from the AER and which AER chamber the scope was washed in along with time date and operator details when unl...

Page 42: ...Operator Tag s Wi Fi Dongle Extra Washer Plaque Barcodes In Out Extra Staff ID Barcodes Extra Scope ID Barcodes The Laptop has the Scope Manager Software installed If a Communications Kit is purchased...

Page 43: ...installed by an Authorised Distributor upon set up of the site however from time to time the software my need to be reinstalled due to PC replacement or reconfiguration or as below 1 Using the USB pr...

Page 44: ...rcode attached this barcode can be used in place of adding a new Smartline barcode 4 Type in the 4 digit Barcode Number into the Scope ID Box preceded by 000000 as shown above 5 Select the Type of Sco...

Page 45: ...ke sure the laptop is connected to the wifi network of the cabinet The MASTER CABINET IP Address is Printed on the ROUTER above or near the Scope Cabinets Click on Function Tab OPERATOR Find a spare U...

Page 46: ...t view Is the power cable securely plugged in power turned On Inspect all data system components power cables are securely plugged in power is switched On Inspect all data system components accessorie...

Page 47: ...ng scopes when loading or unloading the cabinet due to the height of the loaded scopes It is advisable that an appropriate step stool be used Consult with your local Occupational Health Officer to det...

Page 48: ...that are representative of the range of RMDs identified as the most difficult to process that are in use in the HSO Refer to clause 5 2 and e When introducing new or modified RMD packaging or loading...

Page 49: ...ls blown dry with medical air from handpiece ports including biopsy channel and thumb ports for suction and air water Verification is required that all channels allow the passage of air before the dev...

Page 50: ...of AER Automatic Endoscope Repressors should be set to allow for the removal of bulk liquids where possible and or Endoscopes should be purged by manual purging to remove bulk liquid before loading i...

Page 51: ...ering servicing and or replacement of equipment e g filters and parts Maintenance is to be conducted by Authorised Distributors only 3 2 General Anatomy of an Endoscope The image above outlines the va...

Page 52: ...ce for each approved scope Each hose is colour coded and matched with the correct port fittings so that the scope channels can be connected to the scope and system correctly A colour coded sticker on...

Page 53: ...ion Port No On sticker Hose ID mm Hose OD mm Colour Sample Handpiece Auxiliary 1 4 0 6 5 BLACK Biopsy 2 4 0 6 5 WHITE Spare 3 4 0 6 5 LT GREY Umbilical Suction 4 5 8 9 0 DK GREY Air 5 4 0 6 5 LT GREEN...

Page 54: ...rs at each end of the hose 5 Wipe exterior surfaces of hoses with a nonabrasive and lint free cloth 6 Check that all visible debris have been removed 7 Optionally attach hoses to a Washer Rack Hose Co...

Page 55: ...cope Model Number it is very important to exactly capture the precise details including Capital and lower case letters hyphens numbers and spacings e g EC 760ZP V L Examples of approved scope kits can...

Page 56: ...sher the 4 Luer connections are connected to cabinet Scope Connector Hose Kits Note Scope Connector Hose Kits join Endoscopes to the RotaScope Drying Cabinet airflow system High level disinfection of...

Page 57: ...t interior exterior surfaces to be cleaned using soft clean cloths non abrasive cleaning disinfecting products that do not contain ammonia or alcohol Any abrasive cleaning product or cloth scourers wi...

Page 58: ...net The recommended cleaning technique is to wipe all interior surfaces with a non alcoholic disinfectant wipe Cleaning the human touch points where operators frequently touch is particularly importan...

Page 59: ...for cleaning an operating room If the cabinet is located in a scope processing room follow typical procedures for cleaning a scope processing room NOTE Please do not use cleaners containing ammonia o...

Page 60: ...s are manufactured using mostly acrylic plastics stainless steel and ROHS approved electronic components Most parts can be substantially recycled for care of the environment However the cabinets shoul...

Page 61: ...be performed by an Authorised Distributor The service will include inspection calibration if required and includes the replacement of filters pumps and is described in detail in the Annual Service Agr...

Page 62: ...he setup of the Scope ID Barcode when the Scope ID is setup the first time To select the SHORT STORAGE Time using the Barcode Scanner swipe SHORT STORAGE Time Barcode Sticker Operator ID Barcode Scope...

Page 63: ...and Cabinet Cleaning Due Date other screens display details about cabinet pressure pump temperature and speeds and cabinet humidity and temperature Channel monitoring details are also displayed on a t...

Page 64: ...nitoring and other functions The Data Management System creates Visual and Audible notifications of performance and warnings Door Lock Electronic Door locks are located in the middle of each door behi...

Page 65: ...If scopes are suitably washed checked purged and loaded into the RotaScope then residual moisture should never appear on litmus paper when tested in accordance with EN16442 methods If scopes fail to...

Page 66: ...ontrol Screen located on the cabinet door s IFU Instruction For Use IQ OQ PQ Install Qualification IQ askes if the install environment is suitable Room position connection Operation Qualification OQ a...

Page 67: ...the Alarm Acknowledge Button located on the control screen of the Cabinet Controller will allow resetting to normal function Scope timers will adjust storage times on resuming power and notify on the...

Page 68: ...Ports or other names These connection fittings are small specific fittings on the scope umbilical plug or hand piece they are used to connect air hoses or blockers to the scope enabling termination t...

Page 69: ...ical symbols in relation to the product Symbol Meaning Warning Caution IEC Mains Power Supply CE Certification Date Of Manufacture FCC Compliance Instructions For Use Icon Indoor Use Medical Device RC...

Page 70: ...otential contamination of endoscopes and internal surfaces it is recommended scrubs are worn while interacting with the inside of a cabinet Gown In the instance that scrubs are not in use to avoid pot...

Page 71: ...lifting equipment must be used Non commissioned cabinets should be stored in the corresponding crates or plastic film in a clean and dry area Do not attempt to lift cabinets without prior education an...

Page 72: ...ding Lid Top Cap Cabinet including Control screen on Front Door 600mm Wide x 680mm Deep x 2363mm High Pass Through Cabinet including Control Screen Front and Rear Door 600mm Wide x 760mm Deep x 2363mm...

Page 73: ...o persons minimum Storing the product RotaScope cabinets should be installed and stored in continuous operating environment ie Standard office working conditions need to be always provided Room temper...

Page 74: ...g regime on power leads 4 1 5 Securing the product against electrical shock Keep the cabinet free from liquids Maintain a suitable install environment Indoor use only 4 1 6 Securing the product agains...

Page 75: ...f possible 5 Remove the packing straps from around the cabinet and pallet base dispose of in a General Waste Bin 6 Remove the cartons located at one end of the cabinet The Cartons contain Baskets and...

Page 76: ...reen is exactly the same as the front door screen The rear door allows scopes to be loaded in the Reprocessing Room but unloaded in the Procedure Room Operating Theatre Power and data points should ha...

Page 77: ...RotaScope iQ Cabinet Manual Version 1 04 Date 23 November 2021 77 Cabinet Front located in the Reprocessing Room Cabinet Rear seen in the Procedure Room...

Page 78: ...f Door shown 4 2 4 Power Connection 1 Depending on the site layout and location of cabinets plug in any SmartStations and cabinets by using ethernet cables and refer to the site layout drawing provide...

Page 79: ...nds 4 2 6 Verification of the product At completion of install a cabinet must be verified via the Authorised Distributor using the Smartline Medical approved Auditing Tools for an Installation and Ope...

Page 80: ...ce needed The cabinet has a total size of 600mm Wide x 600mm Deep x 2363mm High and requires a minimum of 1200mm Deep and 2400mm Ceiling height and must not be installed less than 100mm from any wall...

Page 81: ...te 23 November 2021 81 4 2 8 Layout plan Each Install Location requires a layout plan and schematic to be drawn prior to install A site layout and install document will be provided prior to installati...

Page 82: ...otaScope iQ Cabinet Manual Version 1 04 Date 23 November 2021 82 4 2 9 Data and Power Schematic Each install Requires a Data and Power Schematic prior to install Fig 6 Example Data and Power Schematic...

Page 83: ...l level clean should be performed by the Hospital Departmental Staff In service training will be carried out by an appropriate training provider and is supplemented by video training 4 3 1 Installatio...

Page 84: ...be used with Smartline approved devices including the SmartStation printer and Communications kit PC See section in this manual SmartStation 2 12 and Communications Kit 2 12 3 5 1 6 Instructions for...

Page 85: ...rporates the electronic control devices of the Cabinet Control System The IAS is located on the top of the cabinet behind the removable fa ade 5 2 How to Use the Product Remotely Automatically Advance...

Page 86: ...sk Frequency Replace the Intake Filter Every 12 months Replace HEPA Filter Every 12 months Replace the Air Pumps Every 24 months Replace Hose Kit Luer Filters Every 6 months Task Action Weekly Cabinet...

Page 87: ...does not start Power Failure Blown Fuse Electronic Failure Restore Power and reset via Alarm Acknowledge Button on Cabinet Control Screen Or replace a part via a service technician Cabinet WHITE Light...

Page 88: ...abinet purple There has been a power outage you need to acknowledge this alarm via the control panel on the door touchscreen Following this be sure to check if the stored endoscopes are within their a...

Page 89: ...e Acrylic lid and housing from electrical parts group Acrylic with other Acrylic parts group electrical parts dispose of insulation stickers filter and silicone hoses f Remove Stainless parts and grou...

Page 90: ...her electronic control boards motors cables and fittings assess with a representative 3 Dispatch goods to a recycle company as agreed upon inspection 8 3 How to Dispose the Product 8 3 1 Test procedur...

Page 91: ...and in other European countries that operate separate collection systems for waste electrical and electronic equipment By disposing of the device in the proper manner you help to avoid possible hazard...

Page 92: ...y 8 3 6 Disposal of batteries The product contains a CR2032 battery Batteries may not be disposed of with the usual domestic waste They may contain toxic heavy metals and are subject to hazard our was...

Page 93: ...tion Kits Various Communication Kit COMMUNICATION KIT Labels N A 9 2 Consumables Image Name Part Number Luer Filters HOSEKIT FILTER Tip Protector TIP PROTECTORS Channel Separators See Authorised Distr...

Page 94: ...in IAS 47 AN302 Air Pump x2 in IAS MINIATURE RADIAL BLOWER Pump Motor Control Board in IAS MOTOR CNTRL BOARD 24VDC Raspberry Pi in IAS Door Blister 48 2525226 IO Power Board in IAS IAS CABINET INTERFA...

Page 95: ...N SENSOR BOARD Channel Monitor Data Board in RotaScope Pole Circular CM RX Rota Door Lock Latch in door frame LOCK SOLENOID Door Cabinet Control Blister Assembly On cabinet door BLACK SILVER DOOR BLIS...

Page 96: ...RotaScope iQ Cabinet Manual Version 1 04 Date 23 November 2021 96 CR2032 Battery Contact Smartline...

Page 97: ...e responsibility that the device Basic UDI DI 9356523xxxx Device name Trade name RotaScope Cabinet Product code ROTA IQ Catalogue number N A Intended purpose A dedicated range of cabinets designed to...

Page 98: ...RotaScope iQ Cabinet Manual Version 1 04 Date 23 November 2021 98 CE Declaration of Conformity 2021 P1...

Page 99: ...RotaScope iQ Cabinet Manual Version 1 04 Date 23 November 2021 99 CE Declaration of Conformity 2021 P2...

Page 100: ...ation Author 1 ApprovedScopeList pdf Aug 2021 sales smartlinemedical com DW 2 CE Declaration Of Conformity F 218 V1 V1 sales smartlinemedical com Attached WS NOTE This Manual will be frequently update...

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