SmartLine Medical SlidaScope iQ Series Installation And User Instructions Manual Download Page 1

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Manual Version

1.06

Date

23 February 2022

Installation and User Instructions

SlidaScope iQ Series

Sliding Drawer Endoscope Drying Cabinet

Summary of Contents for SlidaScope iQ Series

Page 1: ...Manual Version 1 06 Date 23 February 2022 1 Installation and User Instructions SlidaScope iQ Series Sliding Drawer Endoscope Drying Cabinet...

Page 2: ...ts 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 For reasons...

Page 3: ...out 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 Notice Some...

Page 4: ...2 3 Minimum System Requirements 14 2 4 Technical Data Performance characteristics of the SlidaScope Cabinet 15 2 5 Product Compliance 15 2 5 1Compliance Labels 15 2 6 Product elements 18 2 6 1SlidaSco...

Page 5: ...oftware Managing SCOPE ID BARCODES 45 2 13 3 Using Scope Manager Software Managing OPERATOR ID BARCODES 46 3 Safety Instructions 47 3 1 How to Use the Product Safely 48 3 1 1 Control screens and elect...

Page 6: ...ring intervals in normal use 73 4 1 4 Securing the product against shocks 74 4 1 5 Securing the product against electrical shock 74 4 1 6 Securing the product against impact 74 4 2 How to Install the...

Page 7: ...ation 84 5 2 How to Use the Product Remotely Automatically 84 5 3 What to Do in Emergency and Exceptional Situations 84 6 MAINTENANCE 85 6 1 How to Maintain the Product 85 6 1 1 Planned maintenance of...

Page 8: ...3 5 Disposal of packaging waste 90 8 3 6 Disposal of batteries 91 9 APPENDIX I SUPPLIED ACCESSORIES CONSUMABLES AND SPARE PARTS 92 9 1 Supplied accessories 92 9 2 Consumables 92 9 3 Spare replacement...

Page 9: ...d its approved accessories and or performs the unloading loading of the Endoscopes in the SlidaScope The User must not tamper or modify the SlidaScope Any modifications servicing or repairs must be do...

Page 10: ...l Only Smartline Medical Trained Professionals may install service or repair Smartline Medical equipment Avoid contact of electrical components with water and moisture Do not connect to any external e...

Page 11: ...e 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 O...

Page 12: ...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 13: ...ection 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 be familiar with the s...

Page 14: ...ssing costs and delivers operational efficiency and saves time and costs Out of the Cabinet 2 3 Minimum System Requirements Computer and Processor 1 1 gigahertz GHz 64 bit dual core processor Operatin...

Page 15: ...SlidaScope Cabinet Compliance Label affixed at top front of cabinet behind the fa ade Parameter Unit Device name SlidaScope iQ Series Designation Class 1 Type Endoscope Storage Cabinet UNSPC Commodit...

Page 16: ...IAS SmartStation Label is fitted to the side of the SmartStation see labels below 2 5 1 1 SlidaScope Cabinet Product Compliance Label Located at the top front of the Cabinet behind the fa ade 2 5 1 2...

Page 17: ...SlidaScope Cabinet Manual Version 1 06 Date 23 February 2022 17 2 5 1 3 SmartStation Compliance Label Located on the side of the SmartStation mounting enclosure...

Page 18: ...18 2 6 Product elements 2 6 1 SlidaScope Cabinet Components The Cabinet may be configured with a Rear Door 2 13 if it is the Pass Through version The Cabinet may also include an X Ray Kit on the rear...

Page 19: ...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 20: ...S 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 detai...

Page 21: ...a drawer with the Vacuum Manifold Block Top Centre The Drawers are designed to work with a scope storage basket to contain the scope and keep the scope off the drawer surface for airflow and hygiene...

Page 22: ...er runner allows access to the drawer from the front or rear door if fitted The slot in the centre of the basket retains the basket in position via the manifold block on the centre of the drawer The e...

Page 23: ...6 Stainless Steel and are designed to be gentle on scope surfaces whilst resilient for frequent cleaning One basket is located on each Scope Cabinet Drawer and is intended to contain an endoscope duri...

Page 24: ...the patient These 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 go...

Page 25: ...dependently 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 a L...

Page 26: ...cope ports Colour coded hoses match 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...

Page 27: ...ough 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 infection control is better...

Page 28: ...m 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 approx...

Page 29: ...r if fitted Uses of this Cabinet Control Screen Include View Cabinet Environmental Status e g Temperature Humidity View Scope Status Location Name Remaining Time Remaining OOC Dry Status View Cabinet...

Page 30: ...er Detail Screens by touching the section that you want further information about e g Control Panel The Main Screen has quick look icons and readings for a clear overview to get more detail on a topic...

Page 31: ...IAL 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 Jone...

Page 32: ...m 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 c...

Page 33: ...s 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 er...

Page 34: ...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 cleaning cabinet we...

Page 35: ...mation 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 Date advances by 7 days...

Page 36: ...SlidaScope Cabinet Manual Version 1 06 Date 23 February 2022 36 See labels below Wash Label Cabinet Clean Record Storage Label Power Outage Record Incorrect Scope Removal Environmental Alarm Labels...

Page 37: ...o 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 38: ...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 Scree...

Page 39: ...tions 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...

Page 40: ...STICKER 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 deco...

Page 41: ...elect 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 abou...

Page 42: ...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 unlo...

Page 43: ...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 the Laptop...

Page 44: ...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 pro...

Page 45: ...pe ID Barcode Tag supplied with Laptop Kit a Note If scopes already have a 10 digit barcode attached this barcode can be used in place of adding a new Smartline barcode 4 Type in the 4 digit Barcode N...

Page 46: ...nd Scope Location The simple layout of the screen allows you to select the function Make sure the laptop is connected to the wifi network of the cabinet The MASTER CABINET IP Address is Printed on the...

Page 47: ...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 accessories...

Page 48: ...ntrol screens and electrical enclosures Do not open and access the control units without specific training from the Authorised Distributor 3 1 2 Technical life span Annual service and preventative mai...

Page 49: ...ly qualified reference load RMD product family packaging or loading pattern has been demonstrated Requalification of the process shall be performed annually Refer Clause 10 4 Smartline Medical does of...

Page 50: ...s 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 devi...

Page 51: ...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 in...

Page 52: ...ring 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 var...

Page 53: ...ance 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 o...

Page 54: ...on 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 55: ...s 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 Con...

Page 56: ...ope 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 57: ...her 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 e...

Page 58: ...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 wil...

Page 59: ...on to easiest to reach section of the cabinet The recommended cleaning technique is to wipe all interior surfaces with a non alcoholic disinfectant wipe Cleaning the human touch points where operators...

Page 60: ...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 or...

Page 61: ...ressing the battery upwards will disengage the door lock electronically If the battery supplied has aged it may need to be replaced from time to time AER Automated Endoscope Preprocessor Automatic Sco...

Page 62: ...e E g Colonoscope and number of Scope Channels E g 5 Channels The barcode is recorded against a process Eg New Scope Loaded into Cabinet One Position 3 at 10 42am on 15th May 2021 by Mary Smith to set...

Page 63: ...ts Stainless steel scope storage baskets located on each storage drawer Baskets should be routinely cleaned weekly as described in the Cabinet Cleaning section if this IFU Cabinet Control Screen Also...

Page 64: ...area guidelines may provide additional recommendations or limitations on use of drying cabinets Please refer to the legislative directives of your region in addition to the EN16442 2015 Standards Vari...

Page 65: ...d be considered by your HSO policy The recognised description of a DRY endoscope has previously been cited in EN16442 2015 section 6 4 3 1 which states that to test that a scope has been dried Compres...

Page 66: ...s have a Luer fitting on one end to terminate onto the luer fittings located on the Manifold Block which is on each Scope Cabinet Drawer Humidity Cabinet The humidity inside the Scope Cabinet this can...

Page 67: ...a hospital The Scope Cabinet will signify a Power Outage via the cabinet lighting turning PURPLE in colour The use of the Alarm Acknowledge Button located on the control screen of the Cabinet Control...

Page 68: ...bile Flexible Endoscopes SlidaScope Cabinet An Endoscope Drying and Storage Cabinet Features include 8 horizontal drawers independent HEPA filtered Air supply a Data Management System scope Channel Mo...

Page 69: ...SlidaScope Cabinet Manual Version 1 06 Date 23 February 2022 69 Batch Number Recorded ROHS Compliance Serial Number Recorded Unique Device Identifier IEC DC Powered...

Page 70: ...tential 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 pote...

Page 71: ...avy 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 educatio...

Page 72: ...ncluding Lid Top Cap Cabinet including Control screen on Front Door 600mm Wide x 681mm Deep x 1862mm High Pass Through Cabinet including Control Screen Front and Rear Door 600mm Wide x 762mm Deep x 18...

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

Page 74: ...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 against...

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: ...a points should have been installed during building construction of the wall so that cables neatly pass from the top of the cabinet to the power and datapoints Consult appropriate wall cut out drawing...

Page 77: ...oof door kit If a Pass Through Scope Cabinet requires an X Ray proofing an X Ray proof Door can be fitted to the cabinet The shielding complies with a 10kg m2 Lead equivalence protection level suitabl...

Page 78: ...rd Outer Carton Polystyrene corner foam Stretch plastic wrap Protective foam sheets Protective paper coating Metal Crate Ends 4 2 5 Verification of the product At completion of install a cabinet must...

Page 79: ...SlidaScope Cabinet Manual Version 1 06 Date 23 February 2022 79 Fig 4 Spatial Requirements...

Page 80: ...e 23 February 2022 80 4 2 7 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 installatio...

Page 81: ...SlidaScope Cabinet Manual Version 1 06 Date 23 February 2022 81 4 2 8 Data and Power Schematic Each install Requires a Data and Power Schematic prior to install Fig 6 Example Data and Power Schematic...

Page 82: ...ean 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 Installation of the s...

Page 83: ...mbination with other devices The Cabinets are designed to only be used with Smartline approved devices including the SmartStation printer and Communications kit PC See section in this manual SmartStat...

Page 84: ...e of the IAS Integrated Air System which incorporates 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 U...

Page 85: ...cy 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 Clean Use...

Page 86: ...oduct 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...

Page 87: ...binet 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 al...

Page 88: ...electrical parts dispose of insulation stickers filter and silicone hoses f Remove Stainless Steel Baskets and group with metal parts eg Drawer Runners g Remove Acrylic Drawers and separate drawer run...

Page 89: ...er 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 procedure...

Page 90: ...thin the EU 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 pos...

Page 91: ...3 6 Disposal of batteries The product contains a CR2032 battery located in the IAS Batteries may not be disposed of with the usual domestic waste They may contain toxic heavy metals and are subject to...

Page 92: ...ion Kits Various Communication Kit COMMUNICATION KIT Labels N A 9 2 Consumables Image Name Article Number Luer Filters HOSEKIT FILTER Tip Protector TIP PROTECTORS Channel Separators See Authorised Dis...

Page 93: ...take Air Filter 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...

Page 94: ...power pack in IAS 48 DGS 1008A Door Lock Latch in door frame LOCK SOLENOID Door Cabinet Control Blister Assembly On cabinet door BLACK SILVER DOOR BLISTER IQ BLACK DOOR BLISTER SVR Power Board 48 SC...

Page 95: ...SlidaScope Cabinet Manual Version 1 06 Date 23 February 2022 95 CR2032 Battery See local electronics store...

Page 96: ...er our sole responsibility that the device Basic UDI DI 9356523xxxx Device name Trade name SlidaScope Cabinet Product code SLIDA IQ Catalogue number N A Intended purpose A dedicated range of cabinets...

Page 97: ...SlidaScope Cabinet Manual Version 1 06 Date 23 February 2022 97 CE Declaration of Conformity 2021 P1...

Page 98: ...SlidaScope Cabinet Manual Version 1 06 Date 23 February 2022 98 CE Declaration of Conformity 2021 P2...

Page 99: ...ion 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 updated...

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