SmartLine Medical SlidaScope iQ Series Installation And User Instructions Manual
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SmartLine Medical SlidaScope iQ Series Installation And User Instructions Manual

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Installation and User Instructions
SlidaScope iQ Series
Sliding Drawer Endoscope Drying Cabinet
Manual Version 1.06
Date 23 February 2022
1

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  • Page 1 Installation and User Instructions SlidaScope iQ Series Sliding Drawer Endoscope Drying Cabinet Manual Version 1.06 Date 23 February 2022...
  • Page 2 DISCLAIMER Smartline Medical makes no representations or warranties with respect to this manual and, to the maximum extent permitted by law, expressly limits its liability for breach of any warranty that may be implied to the replacement of this manual with another. Furthermore, Smartline Medical reserves the right to revise this publication at any time without incurring an obligation to notify any person of the revision.
  • Page 3 TRADEMARKS Smartline Medical has made every effort to supply trademark information 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 Notice: Some product names used in this manual are used for identification purposes only and may be trademarks of their respective companies.

  • Page 4: Table Of Contents

    Table of Contents PREFACE ............................9 1.1..Description of the Operator ....................9 1.2..Explanation of Safety Warnings .................... 10 1.3 ..Retaining Instructions ........................11 1.4 ..Obtaining Documentation and Information .................. 11 1.4.1 Internet ............................... 11 1.4.2 Ordering Documentation ........................... 11 1.4.3 Support and service ............................
  • Page 5 2.9.3 Control Screen ............................32 2.9.4 Environmental Display Screen ........................33 2.10 .. Visual Signals at Cabinet ........................ 33 2.11 .. Explanation of Auditory and Visual Signals on Cabinet Controller ..........34 2.11.1 Audio Signal at Cabinet Control Screen ....................34 2.11.2 Visual Signals at Control Screen ......................
  • Page 6 3.4.1 Internal Surfaces Cabinet Cleaning IFU (Instructions For Use) ..............59 3.4.2 Cleaning External Surfaces ......................... 60 3.4.3 Safe Disposal ............................... 61 3.5..Terms and definitions used in this manual ................. 61 3.6..Graphical Symbols ........................68 3.6.1 Explanation of graphical symbols in relation to the product ..........68 3.7..
  • Page 7 5.1.1 Verification of correct installation ....................83 5.1.2 Verification of correct maintenance ..................83 5.1.3 Verification of correct cleaning/disinfection................83 5.1.4 Operational environment ......................83 5.1.5 Using the device in combination with other devices ............. 83 5.1.6 Instructions for devices emitting hazardous radiation............83 5.1.7 Instruction for devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body ........
  • Page 8 8.3.4 Disposal of electronic components .................... 90 8.3.5 Disposal of packaging waste......................90 8.3.6 Disposal of batteries ......................... 91 APPENDIX I – SUPPLIED ACCESSORIES, CONSUMABLES AND SPARE PARTS ......... 92 9.1 ..Supplied accessories ........................92 9.2 ..Consumables ..........................92 9.3 ..

  • Page 9: Preface

    Endoscopes in the SlidaScope. The User must not tamper or modify the SlidaScope. Any modifications, servicing, or repairs must be done by a Smartline Medical Trained Professional or a Trained Professional that is under instruction from Smartline Medical. This document is intended for the User and Smartline Medical Trained Professionals of the SlidaScope.

  • Page 10: Explanation Of Safety Warnings

    It is important to review ALL Safety Precautions before operating or servicing the unit. Warning Cabinet • Cabinet to be installed and levelled by a Smartline Medical Trained Professional • Only Smartline Medical Trained Professionals may install, service...

  • Page 11: Retaining Instructions

    Support and service For information about: • Publications and materials • Information, technical assistance or ordering user instructions • Service-related questions Smartline Medical | 55 Cordwell Road, Yandina, Qld, 4561 +61 (07) 54789977 | www.smartlinemedical.com.au Manual Version 1.06 Date 23 February 2022...

  • Page 12: Name And Address Of The 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: Smartline Medical | 55 Cordwell Road, Yandina, Qld, 4561 +61 (07) 54789977 | www.smartlinemedical.com.au...

  • Page 13: Description Of The Product

    SlidaScope Cabinet 2 Description of the product 2.1 Intended Use and Reasonably Foreseeable Misuse This SlidaScope has been designed to dry and store up to eight Flexible Thermolabile Endoscopes. The SlidaScope is intended to be used for Operators in a healthcare environment to store and dry Thermolabile Endoscopes after being reprocessed.

  • Page 14: Minimum System Requirements

    NOTE: The Scope Manager Software is to be installed on a laptop or via a local a PC (with Wi-Fi) The operating system is an integral part of the cabinets and SmartStation data system - using a Smartline Medical supplied COMMUNICATION KIT is preferred. Memory (RAM) 4 gigabyte (GB) RAM (64-bit)

  • Page 15: Technical Data (Performance Characteristics Of The Slidascope Cabinet)

    SlidaScope Cabinet 2.4 Technical Data (Performance characteristics of the SlidaScope Cabinet) Parameter Unit Device name SlidaScope iQ Series Designation Class 1 Type Endoscope Storage Cabinet UNSPC Commodity Code 42295002 Customs HS Code 9018908400 Technical life span 7 Years Expiry Date...
  • Page 16 SlidaScope Cabinet IAS Label is fitted to the side of the 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 façade 2.5.1.2 Integrated Air System Compliance label Located on the right rear side of the IAS on top of the cabinet...
  • Page 17 SlidaScope Cabinet 2.5.1.3 SmartStation Compliance Label Located on the side of the SmartStation mounting enclosure Manual Version 1.06 Date 23 February 2022...

  • Page 18: Product Elements

    SlidaScope Cabinet 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 door (13) to prevent transmission of X-Ray through the cabinet.

  • Page 19: Ias Components

    SlidaScope Cabinet 2.6.2 IAS Components Integrated Air System – Located on top of Cabinet – Contains Pumps and Electrical Parts Service by an approved technician only Located on the top of the drying cabinet, the Integrated Air System (IAS) is an assembled unit that provides the vacuum and HEPA filtered air for the drying function of the cabinet.

  • Page 20: System Connection Overview

    SlidaScope Cabinet 2.6.3 System Connection Overview Connecting Devices – Data Network Overview • On the diagram below – the IAS represents a Cabinet • Each Cabinet has an IAS 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 –...

  • Page 21: Slidascope Drawer Details

    SlidaScope Cabinet 2.6.4 SlidaScope Drawer Details 2.6.4.1 Identifying Drawer Components The SlidaScope Drawer – Identifying the components Image above shows 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 SlidaScope Cabinet 2.6.4.2 The Drawer and Scope Storage Basket The SlidaScope Drawer and Basket are used to store and connect the Endoscope to the cabinet air system for drying of the scope channels via connection Hose Kits and the air manifold block. Image shows a Basket and Drawer The SlidaScope Drawer is mounted on a two-way runner.

  • Page 23: Slidascope Scope Storage Basket Details

    SlidaScope Cabinet 2.6.5 SlidaScope Scope Storage Basket Details Basket – Endoscope Storage Endoscope Storage Baskets are constructed with high grade 316 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 during drying and storage.

  • Page 24: Understanding Product And Controls And Indicators

    SlidaScope Cabinet 2.7 Understanding Product and Controls and Indicators 2.7.1 What is the product? SlidaScope is an approved Medical Drying and Storage Cabinet for drying the outside surfaces and internal tubes in flexible medical endoscopes. SlidaScope Cabinets hold eight endoscopes in baskets on drawers located in the cabinet (Horizontal storage of endoscopes) 2.7.2 How does the product work? –...
  • Page 25 SlidaScope Cabinet NEW Feature: Channel monitoring: Channel Monitoring sensors monitor the air flow through each scope channel (Lumen). The vacuum manifold, located on the SlidaScope Drawer, has seven connection nipples connected to the scopes 7 channels via the Scope Connection Hose Kits. Inside the vacuum manifold is a sensor board with 7 sets of sensors to reliably monitor the air that passes through each tiny scope channel capillary.
  • Page 26 SlidaScope Cabinet • Other data is captured includes, pump temperature, motor speeds, door sensors and other controls Alarms via lighting, data records and printed notifications occur for various • warning methods and record keeping Operation of the cabinet: Short Description for Loading a Scope At AER Washer: •...
  • Page 27 SlidaScope Cabinet The slowest part of a scope to dry is the external control knobs on the scope control handpiece which can take up to three hours – less if patted dry with clean, lint free cloth before loading For best results Smartline recommends purging bulk moisture out of scopes before loading, by use of medical air gun to blow out channels manually Typical Humidity at normal preferred operation conditions: Room Temperature...
  • Page 28 SlidaScope Cabinet Cabinet/environmental conditions: Recommended that the cabinet is located in room 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 approximately +15 Pa, Vacuum in Air System – approximately -17,000 Pa.

  • Page 29: Understanding The User Interface

    SlidaScope Cabinet 2.8 Understanding the User Interface Cabinet Control Screen The Cabinet Control Screen is located on the front cabinet door (and rear cabinet door if fitted) Uses of this Cabinet Control Screen Include: • View Cabinet Environmental Status e.g. Temperature, Humidity •...

  • Page 30: Operating Panels Of Cabinet Control Screens

    SlidaScope Cabinet 2.9 Operating Panels of Cabinet Control Screens 2.9.1 Cabinet Control Screen The Cabinet Control Screen is the main display and control panel for viewing and managing the cabinet. The Cabinet Control Screen is a Touch Screen – the Touch Screen is used to navigate to further Detail Screens by touching the section that you want further information about e.g.

  • Page 31: Endoscope Detail Display Screen

    SlidaScope Cabinet 2.9.2 Endoscope Detail Display Screen Endoscope Detail Display Screen shown below. Features shown include: Pressing the Location 1-8 Button on the Main Screen will take you here …… • LOCATION e.g. “Location 1” (Top Drawer) • SCOPE NAME e.g. “S1” •...

  • Page 32: Control Screen

    SlidaScope Cabinet 2.9.3 Control Screen The Control Screen is the place to action features: Features: • MAIN – Press to return to Main Screen • ALARM ACK – Press to Acknowledge Alarms – Resets the coloured lights to Green • Integrated AIR System ON/OFF - Press to Turn Air System ON/OFF •...

  • Page 33: Environmental Display Screen

    SlidaScope Cabinet 2.9.4 Environmental Display Screen The Environmental Display has the current readings 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 errors are displayed on screen and Errors are printed via the SmartStation Printer.

  • Page 34: Explanation Of Auditory And Visual Signals On Cabinet Controller

    SlidaScope Cabinet 2.11 Explanation of Auditory and Visual Signals on Cabinet Controller 2.11.1 Audio Signal at Cabinet Control Screen Audio Signals at Cabinet Control Screen No Icon Description Location Tone Scan Operator ID Barcode (Staff ID Badge) - Door Voice Unlocks door Control Screen...

  • Page 35: Visual Signals At Control Screen

    SlidaScope Cabinet 2.11.2 Visual Signals at Control Screen Visual Signals at Cabinet Control Screen No Icon Description Location Type The Cabinet Control Screen – Located on Front or Cabinet Screen Rear Doors is the main visual location to see the Control Display Cabinet Status and Stored Scope Status - Various...
  • Page 36 SlidaScope Cabinet See labels below Wash Label Cabinet Clean Record Storage Label Power Outage Record Incorrect Scope Removal Environmental Alarm Labels Manual Version 1.06 Date 23 February 2022...

  • Page 37: Smartstation Overview

    Multiple SmartStations may be added to the system to make scanning and or system or error reporting convenient in each area Printer Sticker roll ID is Smartline Medical Part No 46.L4062-40 Label Roll – 40x62mm – 800 Labels per Roll (40mm Core) Manual Version 1.06...

  • Page 38: The Smartstation Touch Screen

    SlidaScope Cabinet 2.12.1 The SmartStation Touch Screen SmartStation – 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 Screen may be used in conjunction with the Barcode Scanner to scan Operator ID, Scope ID and various function Barcodes Manual Version 1.06...

  • Page 39: Operation Of The Smartstation At The Aer Scope Washer

    SlidaScope Cabinet 2.12.2 Operation of the SmartStation at the AER Scope Washer To ensure that a scope is correctly processed before storage, the SmartStation and Barcode Scanner are used to identify: 1. AER Chamber Barcodes Eg Washer 1, Chamber 2 2.
  • Page 40 SlidaScope Cabinet SCOPE ID BARCODE STICKERS are supplied upon installation and additional Scope ID Barcodes are available from your Cabinet Sales Representative Typically, the SCOPE ID BARCODE 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 decontamination of the...
  • Page 41 SlidaScope Cabinet 2.12.2.1 The process of scanning a scope Through an AER Washer 2.12.2.2 Loading a scope IN to an AER Washer Scan Operator ID Barcode (Staff ID Badge) - “Audio Tone” “Click” Scan Scope ID Barcode (Scope Id Barcode Sticker. Typically located on Scope Handpiece) “Audio Tone”...
  • Page 42 SlidaScope Cabinet 2.12.2.3 Unloading a scope OUT of an AER Washer (When wash cycle is complete) Scan Operator ID Barcode (Staff ID Badge) - “Audio Tone” “Click” Scan Scope ID Barcode (Scope Id Barcode Sticker – located on Scope Handpiece) “Audio Tone” “Click” Scan Barcode AER SmartStation Washer Chamber ID (A Barcode Sticker is Located on the AER Washer Chamber) “Audio Tone”...

  • Page 43: Communication Kit (Part # Communication Kit)

    SlidaScope Cabinet 2.12.3 Communication Kit (Part # COMMUNICATION KIT) Communications Kit Bag Communications Kit Bag The Communications Kit is an accessory kit. When a Communications Kit is supplied it will be configured and installed by the installation team The Communication Kit contains: •...

  • Page 44: Scope Manager Software - Overview

    SlidaScope Cabinet 2.13 Scope Manager Software – Overview Scope Manager Software: is loaded onto the Communications Kit Laptop Computer or an agreed Hospital Computer Terminal. Scope Manager Software is used to manage • SCOPE ID BARCODES • OPERATOR ID BARCODES 2.13.1 Installing Scope Manager Software Usually, the software is 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...

  • Page 45: Using Scope Manager Software - Managing Scope Id Barcodes

    SlidaScope Cabinet 2.13.2 Using Scope Manager Software – Managing SCOPE ID BARCODES Scope Manager SCOPE Screen Tab This software is simple to use and will be frequently used to manage OPERATOR ID BARCODES and SCOPE ID BARCODES and Scope Location 1.

  • Page 46: Using Scope Manager Software - Managing Operator Id Barcodes

    SlidaScope Cabinet • NOTE - RETRIEVE Function is used for when you would like to see the pre-set parameters of an existing Scope barcode i.e. it will populate the fields with previously set details. 2.13.3 Using Scope Manager Software – Managing OPERATOR ID BARCODES Scope Manager USER Screen Tab This software is simple to use and will be frequently used to manage OPERATOR ID BARCODES and SCOPE ID BARCODES and Scope Location...

  • Page 47: Safety Instructions

    SlidaScope Cabinet 3 Safety Instructions • Cabinets MUST BE positioned on a stable, level floor. • Cabinet power cable must be securely plugged into a standard GPO & switched On. • Inspect door components of the equipment prior to use as well as daily – inspection to also be performed on rear door where fitted.

  • Page 48: How To Use The Product Safely

    SlidaScope Cabinet All the Environmental Conditions are measured and recorded by the Data Management System as required to meet the EN16442 standards. During cabinet operation, if an operational parameter exceeds a set operational value an Alarm or Warning may be triggered, and the following will occur: •...
  • Page 49 Requalification of the process shall be performed annually. Refer Clause 10.4. Smartline Medical does offer a performance Qualification Service for the RotaScope Cabinets in line with the requirements of AS/NZS4187:2014 and BS EN16442:2015.

  • Page 50: Safety Information Related To The Intended Use And Reasonably Foreseeable Misuse

    SlidaScope Cabinet 3.1.4 Safety information related to the intended use and reasonably foreseeable misuse. 3.1.4.1 Condition of the Endoscope Verification is required that all channels allow the passage of air before the device is loaded into the storage cabinet when a scope has been cleaned and disinfected using a manual cleaning procedure.

  • Page 51: Personal Protective Equipment

    SlidaScope Cabinet 3.1.5 Personal Protective Equipment Standard hospital PPE (scrubs or gown, masks and gloves) should be used when interacting with the internals of this cabinet to reduce any chance of contamination. Personal hygiene (hand washing or use of gloves) must be considered when interacting with the inside of the cabinet.

  • Page 52: Maintenance Safety Information

    SlidaScope Cabinet 3.1.7 Maintenance safety information To ensure you get the best performance out of your cabinet, it is an operational requirement to have a Maintenance Contract in place. Maintenance Contracts are to be set up through the Maintenance Department. A Maintenance Contract is an annual service agreement covering servicing, and or, replacement of equipment e.g., filters and parts.

  • Page 53: The Scope Connector Hose Kits

    SlidaScope Cabinet 3.3 The Scope Connector Hose Kits Scope Connector Hose Kits are separately purchased for each scope that is to be loaded into the cabinets. Colour Coded Hose Connection Hoses Examples: Hose colour is matched to similar connection port identification stickers A Luer Lock fitting at one end of the connecting hose, terminates to the relevant Luer Nipple on the cabinet Vacuum Manifold Block –...

  • Page 54: Scope Connector Hose Kits - Colour Coding

    SlidaScope Cabinet 3.3.1 Scope Connector Hose Kits - Colour Coding: Scope Connector Hose Kit - Colour Coding: The manifold is fitted with a colour coded sticker to match with coloured hoses Name/Location Port No Hose ID Hose OD Colour Sample sticker Handpiece Auxiliary...

  • Page 55: Scope Connector Hose Kits - Cleaning Ifu

    SlidaScope Cabinet 3.3.2 Scope Connector Hose Kits – Cleaning IFU RECOMMENDED STEPS for Manual Cleaning Scope Connector Hose Kits: (IFU) Instructions For Use 1. Prepare appropriate amount of cleaning solution (biofilm remover or enzymatic detergent solution) in a sink, as per the chemical manufacturer’s instructions.

  • Page 56: Selecting Scope Connector Hose Kits, For Your Fleet Of Scopes

    SlidaScope Cabinet 3.3.3 Selecting Scope Connector Hose Kits, for your fleet of Scopes There are many Brands and Models of Endoscopes available. Each scope has specific connection points that need to be matched with approved connection fittings. Approved fittings ensure that air will successfully pass through the scope to dry the scope in the recommended time in the cabinet.

  • Page 57: Washer Rack Hose Connection Kit (Optional)

    SlidaScope Cabinet 3.3.4 Washer Rack Hose Connection Kit (Optional) A modular accessory is available, that can be utilised during an Automated Cleaning Process. Washer Rack Hose Connection Kit (09.SC-WRHKC) The Washer Rack Hose Connection Kit is an accessory used by the Central Sterilising Department in combination with some type of Automated Instrument Washer The purpose of the Washer Rack Hose Connection Kit is to connect several hoses (Scope Connector Hose Kits) simultaneously to reduce reprocessing costs...

  • Page 58: Cleaning Of Cabinets Ifu (Instructions For Use)

    SlidaScope Cabinet 3.4 Cleaning of Cabinets IFU (Instructions For Use) In accordance with Standards EN16442:2015, the cabinet cleaning cycle frequency is stated by the manufacturer. Cabinets must be cleaned in no more than a seven-day repeated cycle. The cabinet lighting will provide a visual warning when cleaning is due. The cabinet will illuminate in BLUE color lighting, 24 hours before the Clean Due expiry time.

  • Page 59: Internal Surfaces Cabinet Cleaning Ifu (Instructions For Use)

    SlidaScope Cabinet 3.4.1 Internal Surfaces Cabinet Cleaning IFU (Instructions For Use) Cleaning of the SlidaScope cabinet should be carried out in accordance with local guidelines in less than 7-day intervals. • Remove all scopes from the cabinets and store appropriately •...

  • Page 60: Cleaning External Surfaces

    SlidaScope Cabinet 3.4.2 Cleaning External Surfaces Cleaning external surfaces: Wipe down all surfaces with a mild detergent and soft lint free cloth • Pay particular attention to high human touch-points such as door handles • If the cabinet is located within an operating room – follow typical procedures for cleaning an operating room •...

  • Page 61: Safe Disposal

    SlidaScope Cabinet 3.4.3 Safe Disposal Test procedure to facilitate safe disposal of the device and related waste substances The Cabinets 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 should be thoroughly cleaned before disposal, and consultation with local recycling parties should be undertaken in accordance with your environmental, infection control and recycling policy.
  • Page 62 SlidaScope Cabinet SmartStation Team and affixed to each AER washer chamber – the Barcode identifies specifically the Washer ID, Name and Chamber Number – when Operator and Scope are scanned, the system records a unique wash cycle reference Scanning a scope out of the washer confirms that the wash cycle was complete and successful NOTE –...
  • Page 63 SlidaScope Cabinet The Long Storage Time is the maximum storage time allowed for that scope and is determined by the setup of the Scope ID Barcode when the Scope ID is setup the first time – In some regions a partial wash of the scope is acceptable i.e.
  • Page 64 SlidaScope Cabinet reprocessing by use of “Oldest Stored Scope First” The positive pressure inside the cabinet – this should be greater than the adjacent rooms ensuring positive pressured HEPA Filtered Air is always purging out of the cabinet preventing room air from occupying the cabinet The Cabinet pressure can be viewed on the Main Cabinet Pressure...
  • Page 65 SlidaScope Cabinet located under the Cabinet Control Screen – pressing the battery firmly upwards will power the door lock to release the door. In case of a lock failure the cabinet door can be unlocked by removing the small lock retaining screws located on the outside edge of the door handle.
  • Page 66 SlidaScope Cabinet A Hard Reset may be done by using the Hard Reset Button which is located at the top of the cabinet behind the top façade. The hard reset button restarts the Linux Computer System and normal operating parameters. The cabinet will reset and restart after pressing the Hard Hard Reset Reset Button –...
  • Page 67 SlidaScope Cabinet that a scope is not in the cabinet – OOC is a total of 3 hours (180 Minutes) – OOC starts upon swiping the barcode of the scope upon removal from the AER (Washer) – count down stops when the scope is loaded into the cabinet –...

  • Page 68: Graphical Symbols

    SlidaScope Cabinet connection fittings of an endoscope, to dry endoscope lumens. Bought separately. Also called Channel Connector, Channel Port, Scope Fitting, Button Ports or other names These connection fittings are small specific fittings on the Scope Port scope umbilical plug or hand piece – they are used to connect air hoses or blockers to the scope enabling termination to the cabinet airflow or other fittings for flushing the endoscope channels internally.
  • Page 69 SlidaScope Cabinet Batch Number Recorded ROHS Compliance Serial Number Recorded Unique Device Identifier IEC DC Powered Manual Version 1.06 Date 23 February 2022...

  • Page 70: Personal Protective Equipment

    SlidaScope Cabinet 3.7 Personal Protective Equipment Instruction To avoid potential contamination of endoscopes Gloves and internal surfaces it is recommended gloves are worn while interacting with the inside of a cabinet. To avoid potential contamination of endoscopes Scrubs and internal surfaces it is recommended scrubs are worn while interacting with the inside of a cabinet.

  • Page 71: Preparation

    SlidaScope Cabinet 4 PREPARATION 4.1 How to Transport and Store the Product Cabinets and additional parts thereof are delivered in a dismantlable crate. Only suitably trained technicians should attempt the unloading and transporting the items. While the cabinet remains in a crate, heavy lifting equipment must be used. Non-commissioned cabinets should be stored in the corresponding crates or plastic film in a clean and dry area.

  • Page 72: Dimensions, Mass And Center Of Gravity

    SlidaScope Cabinet 4.1.1 Dimensions, mass and center of gravity Cabinet Body 600mm Wide x 600mm Deep x 1862mm High including 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 1862mm High.

  • Page 73: Lifting, Handing And Transporting The Product

    SlidaScope Cabinet 4.1.2 Lifting, handing and transporting the product Prior to each installation, it is very important to confirm access to the location of the cabinets. Mapping the complete route to be sure that a cabinet can be moved through the department / hospital without obstacles / impediments is necessary, to ensure the installation can be completed within the allocated timeframe.

  • Page 74: Securing The Product Against Shocks

    SlidaScope Cabinet 4.1.4 Securing the product against shocks Only use suitable shock protected power outlets, maintain a test and tag regime on power leads. 4.1.5 Securing the product against electrical shock • Keep the cabinet free from liquids • Maintain a suitable install environment •...

  • Page 75: How To Install The Product

    SlidaScope Cabinet 4.2 How to Install the Product Installation of the Cabinet must be only done by a minimum of two suitably trained, approved installation technicians and under the supervision of an Approved Distributor 4.2.1 Removal of the transport and packaging restraints – unpacking the cabinet from the crate The cabinets arrive on site in a crate which can be fully dismantled.

  • Page 76: Pass Through Units

    SlidaScope Cabinet 4.2.2 Pass Through Units If specifically ordered, Pass-Through cabinets may be supplied with a rear door, which includes a display screen, and scanner. The function of the rear door screen 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).
  • Page 77 SlidaScope Cabinet X-Ray proof 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, suitable for most theatres that perform X-Ray functions. X-Ray Proof Door shown Manual Version 1.06 Date 23 February 2022...

  • Page 78: Power Connection

    4.2.5 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 Operational Qualification (IQ & OQ) in accordance with EN16442 and AS4187 or local standards.
  • Page 79 SlidaScope Cabinet Fig. 4 – Spatial Requirements Manual Version 1.06 Date 23 February 2022...

  • Page 80: Layout Plan

    SlidaScope Cabinet 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 installation for each site. Fig. 5 – Example Layout Plan Manual Version 1.06 Date 23 February 2022...

  • Page 81: Data And Power Schematic

    SlidaScope Cabinet 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 Manual Version 1.06 Date 23 February 2022...

  • Page 82: Required Tools

    SlidaScope Cabinet 4.2.9 Required Tools Never attempt to lift or move a cabinet without the appropriate training and support, always use two technicians to move and lift a cabinet. Required tools: • Battery Drill/Driver (Philips Head No2 Driver) • Level •...

  • Page 83: Operation/Use Verification

    SlidaScope Cabinet 5 OPERATION/USE verification 5.1.1 Verification of correct installation Follow the IQ and OQ procedure as per EN16442:2015 Standards – this should be performed by the Authorised Distributor 5.1.2 Verification of correct maintenance Manage the annual servicing requirements via an Annual Service Agreement 5.1.3 Verification of correct cleaning/disinfection.

  • Page 84: Starting/Stopping The Product Operation

    SlidaScope Cabinet • The storage times and stored Scope Information will not be lost by performing a Hard Reset Image above shows use of the “Hard Reset Button”, located behind the façade at the top front of the SlidaScope Cabinet 5.1.9 Starting/Stopping the product operation To Start and Stop the products operation, simply remove power to the cabinet via the GPO.

  • Page 85: Maintenance

    SlidaScope Cabinet 6 MAINTENANCE The SlidaScope shall only be maintained by a qualified and trained person under the instruction of Smartline Medical. 6.1 How to Maintain the Product 6.1.1 Planned maintenance of SlidaScope. Maintenance tasks shall be done according to the following plan:...

  • Page 86: Troubleshooting And Repair

    7.1.1 Troubleshooting and repair by non-skilled persons If an issue cannot not be resolved by the following troubleshooting guide, please contact your Smartline Medical representative and a service technician will be in contact to troubleshoot or attend your site if required.

  • Page 87: Frequently Asked Questions

    SlidaScope Cabinet 7.2 Frequently Asked Questions Question Answer There has been a power outage, you need to acknowledge this alarm via the control panel on Why is my cabinet the door touchscreen. Following this be sure to purple? check if the stored endoscopes are within their allocated storage timeframe.

  • Page 88: Disposal

    SlidaScope Cabinet 8 DISPOSAL Prior to disposal, the cabinet must undergo a thorough disinfection. 8.1 How to Disassemble the Product To disassemble the product: Disassemble the Cabinet into obvious assemblies using basic hand tools a) Remove Acrylic Lid Top Caps – separate with other Acrylic materials eg Cabinet Body b) Remove Aluminum Doors and Discard Door Seals –...

  • Page 89: How To Recycle Parts

    SlidaScope Cabinet 8.2 How to Recycle Parts See in conjunction with 8.3 Safe disposal of product To recycle part A: Acrylic Plastics 1. Contact a plastic recycling company 2. Gather and Assess Acrylic Plastic with representative 3. Dispatch goods to recycle company as agreed upon inspection To recycle part B: Metals 1.

  • Page 90: Disposal Of The Device

    SlidaScope Cabinet 8.3.2 Disposal of the device To dispose the device: Confirm that your facility has resources and trained personnel to disinfect than disassemble the product for selective recycling in conjunction with selected recycling representatives. 8.3.3 Disposal of waste substances: •...

  • Page 91: Disposal Of Batteries

    SlidaScope Cabinet To dispose packaging waste: 1. Separate materials into wood, cardboard, metal, general waste 2. Check HSO waste management guidelines 3. Recycle and dispose of product by category 8.3.6 Disposal of batteries The product contains a CR2032 battery located in the IAS. Batteries may not be disposed of with the usual domestic waste.

  • Page 92: Appendix I - Supplied Accessories, Consumables And Spare Parts

    SlidaScope Cabinet 9 APPENDIX I – SUPPLIED ACCESSORIES, CONSUMABLES AND SPARE PARTS 9.1 Supplied accessories Image Name Article Number Hose Connection Kits Various Communication Kit COMMUNICATION KIT Labels 9.2 Consumables Image Name Article Number Luer Filters HOSEKIT FILTER Tip Protector TIP PROTECTORS See Authorised Channel Separators...
  • Page 93 SlidaScope Cabinet HEPA Filter in IAS HEPA FILTER H13 Intake Air Filter in IAS 47.AN302 MINIATURE RADIAL Air Pump x2 in IAS BLOWER MOTOR CNTRL BOARD Pump Motor Control Board in IAS 24VDC Raspberry Pi in IAS/Door Blister 48.2525226 IAS CABINET INTERFACE IO Power Board in IAS BOARD TRANSFORMER MCC...
  • Page 94 SlidaScope Cabinet Vacuum Sensor in IAS 48.SC-CE-PVM Cabinet pressure monitor in IAS 48.SC-SY-HTS Data Switch/power pack in IAS 48.DGS-1008A Door Lock/Latch – in door frame LOCK SOLENOID Door Cabinet Control Blister Assembly – On cabinet door DOOR BLISTER IQ BLACK - BLACK DOOR BLISTER SVR - SILVER...
  • Page 95 SlidaScope Cabinet See local electronics CR2032 Battery store Manual Version 1.06 Date 23 February 2022...

  • Page 96: Declaration Of Conformity For Class I Device

    Unique identification number of this Document: See Document no. F-218 V1 We (manufacturer or authorised representative): Business name: Smartline Medical Registered trade name or trademark: Smartline Medical Pty Ltd Address: 55 Cordwell Rd, Yandina Qld, 4561 Country: Australia Declare under our sole responsibility that the device:...
  • Page 97 SlidaScope Cabinet CE Declaration of Conformity 2021: P1 Manual Version 1.06 Date 23 February 2022...
  • Page 98 SlidaScope Cabinet CE Declaration of Conformity 2021: P2 Manual Version 1.06 Date 23 February 2022...

  • Page 99: Related Documentation

    SlidaScope Cabinet 1 RELATED DOCUMENTATION Version Document Title Location Author ApprovedScopeList.pdf sales@smartlinemedical.com 2021 sales@smartlinemedical.com CE Declaration Of Conformity F-218 V1 Attached NOTE: This Manual will be frequently updated with additional information FAQ questions and more – please refer to your Authorised Distributor for updated versions Manual Version 1.06 Date 23 February 2022...

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