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

Endoscope drying cabinet
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RotaScope iQ Cabinet
Installation and User Instructions
RotaScope iQ Series
Endoscope Drying Cabinet
Manual Version 1.04
Date 23 November 2021
1

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  • Page 1 RotaScope iQ Cabinet Installation and User Instructions RotaScope iQ Series Endoscope Drying Cabinet Manual Version 1.04 Date 23 November 2021...
  • Page 2 RotaScope iQ Cabinet 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 RotaScope iQ Cabinet 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.

  • Page 4: Table Of Contents

    RotaScope iQ Cabinet Table of Contents PREFACE ............................. 8 1.1 ..Description of the Operator ....................... 8 1.2 ..Explanation of Safety Warnings ....................9 1.3 ..Retaining Instructions ......................10 1.4 ..Obtaining Documentation and Information ................10 1.4.1 Internet ..............................10 1.4.2 Ordering Documentation ........................
  • Page 5 RotaScope iQ Cabinet 2.11.3 Labels at SmartStation (Print Station): ..................35 2.12 .. SmartStation Overview ......................36 2.12.1 The SmartStation Touch Screen ....................37 2.12.2 Operation of the SmartStation located at the AER Scope Washer ......38 2.12.3 Communication Kit (Part # COMMUNICATION KIT) ............42 2.13 .
  • Page 6 RotaScope iQ Cabinet 4.1.1 Dimensions, mass and center of gravity ................72 4.1.2 Lifting, handing and transporting the product..............73 4.1.3 Storing the product during 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 .................
  • Page 7 RotaScope iQ Cabinet 6.2..How to Inspect the Product ..................... 86 6.2.1 Weekly inspection tasks ......................86 TROUBLESHOOTING AND REPAIR ..................87 7.1..How to Identify and Solve Problems ................87 7.1.1 Troubleshooting and repair by non-skilled persons ............87 7.2..

  • Page 8: Preface

    Endoscopes in the RotaScope. The User must not tamper or modify the RotaScope. 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.

  • Page 9: Explanation Of Safety Warnings

    • Cabinet to be installed and levelled by an Approved Distributor • 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 devices.

  • Page 10: 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 1.04 Date 23 November 2021...

  • Page 11: 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 12: Description Of The Product

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

  • Page 13: 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 14: Technical Data (Performance Characteristics Of The Rotascope Cabinet)

    RotaScope iQ Cabinet 2.4 Technical Data (Performance characteristics of the RotaScope Cabinet) Parameter Unit Device name RotaScope 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 15 RotaScope iQ 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 RotaScope 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 16 RotaScope iQ Cabinet Located on the side of the SmartStation mounting enclosure Manual Version 1.04 Date 23 November 2021...

  • Page 17: Product Elements

    RotaScope iQ Cabinet 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 door (8) to prevent transmission of the X-Ray through the cabinet.

  • Page 18: Ias Components

    RotaScope iQ Cabinet 2.6.2 IAS Components Integrated Air System – Located on top of Cabinet – Contains Pumps and Electrical Parts Service by an Authorised Distibutor 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 19: System Connection Overview

    RotaScope iQ 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 20: Internal Cabinet Components

    RotaScope iQ Cabinet 2.6.4 Internal Cabinet Components 2.6.4.1 Identifying the Hang Hook and Connection components The RotaScope Centre Pole, Hang Hooks and Vacuum Manifold A rotating Centre Pole is located inside each RotaScope cabinet. Up to 9 Endoscopes are vertically hung on numbered Hang Hooks.
  • Page 21 RotaScope iQ Cabinet 2.6.4.2 Hang Hooks – options A RotaScope Cabinet Centre Pole may be fitted with various hooks to store different scopes Image above left shows an ENT Hang hook and optional 51.SC12-ENTH Cable Hang Hook Image above right shows a standard hang hook which is provided as High or Low version via a long and short stainless hang rods which are set up at install to suit your scopes.
  • Page 22 RotaScope iQ Cabinet 2.6.4.3 RotaScope Centre Pole and 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 assistance in better understanding the various Hang Hook Options to make hanging scopes easy and safe Manual Version 1.04 Date 23 November 2021...

  • Page 23: Understanding Product And Controls And Indicators

    RotaScope iQ Cabinet 2.7 Understanding Product and Controls and Indicators 2.7.1 What is the product? RotaScope is an approved Medical Drying and Storage Cabinet for drying the outside surfaces and internal tubes in flexible medical endoscopes. RotaScope Cabinets hold up to nine endoscopes on Hang Hooks located in the cabinet (Vertical storage of endoscopes) 2.7.2 How does the product work? –...
  • Page 24 RotaScope iQ Cabinet NEW Feature: Channel monitoring: Channel Monitoring sensors monitor the air flow through each scope channel (Lumen). Each vacuum manifold, located on the RotaScope Centre Pole, has seven connection nipples connected to the scopes 7 channels via the Scope Connection Hose Kits.
  • Page 25 RotaScope iQ 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 26 RotaScope iQ Cabinet The scope channels usually DRY in under 1.5 hours 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...
  • Page 27 RotaScope iQ 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 28: Understanding The User Interface

    RotaScope iQ Cabinet 2.8 Understanding the User Interface The following images outline the display screens on the cabinet. 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: •...
  • Page 29 RotaScope iQ Cabinet Main Screen: Note: Blue Rectangles shown navigate to other screens when pressed. The Main Screen has quick look icons and readings for a clear overview, to get more detail on a topic each area acts as a button to the detail screen. (Press the relevant Icon – see below) Coloured icons indicate status: E.g.

  • Page 30: Endoscope Detail Display Screen

    RotaScope iQ 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” (Hook) • SCOPE NAME e.g. “S1” •...

  • Page 31: Control Screen

    RotaScope iQ 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 •...

  • Page 32: Environmental Display Screen

    RotaScope iQ 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 33: Explanation Of Auditory And Visual Signals On Cabinet System

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

  • Page 34: Visual Signals At Control Screen

    RotaScope iQ 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 35: Labels At Smartstation (Print Station)

    RotaScope iQ Cabinet 2.11.3 Labels at SmartStation (Print Station): See labels below Wash Label Cabinet Clean Record Storage Label Power Outage Record Incorrect Scope Removal Environmental Alarm Labels Manual Version 1.04 Date 23 November 2021...

  • Page 36: 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 1.04...

  • Page 37: The Smartstation Touch Screen

    RotaScope iQ 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 1.04...

  • Page 38: Operation Of The Smartstation Located At The Aer Scope Washer

    RotaScope iQ Cabinet 2.12.2 Operation of the SmartStation located 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 39 RotaScope iQ Cabinet SCOPE ID BARCODE STICKERS are supplied upon installation and additional Scope ID Barcodes are available from an Authorised Distributor 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 40 RotaScope iQ 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 41 RotaScope iQ 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 42: Communication Kit (Part # Communication Kit)

    RotaScope iQ Cabinet 2.12.3 Communication Kit (Part # COMMUNICATION KIT) 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 43: Scope Manager Software - Overview

    RotaScope iQ 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 44: Using Scope Manager Software - Managing Scope Id Barcodes

    RotaScope iQ 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 45: Using Scope Manager Software - Managing Operator Id Barcodes

    RotaScope iQ Cabinet 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 The simple layout of the screen allows you to select the function •...

  • Page 46: Safety Instructions

    RotaScope iQ 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 47: How To Use The Product Safely

    RotaScope iQ 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 48: Pq Performance Qualification

    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 49: Safety Information Related To The Intended Use And Reasonably Foreseeable Misuse

    RotaScope iQ 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 50: Personal Protective Equipment

    RotaScope iQ 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 51: Maintenance Safety Information

    RotaScope iQ 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 52: Scope Connector Hose Kits

    RotaScope iQ Cabinet 3.3 Scope Connector Hose Kits Scope Connector Hose Kits are separately purchased for each scope that is to be loaded into the cabinets. Colour Coded Scope Connector Hose Kit 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 53: Scope Connector Hose Kits - Colour Coding

    RotaScope iQ 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...

  • Page 54: Scope Connector Hose Kits - Cleaning Ifu

    RotaScope iQ 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 55: Selecting Scope Connector Hose Kits, For Your Fleet Of Scopes

    RotaScope iQ 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 56: Washer Rack Hose Connection Kit (Optional)

    RotaScope iQ 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 57: Cleaning Of Cabinets Ifu (Instructions For Use)

    RotaScope iQ 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 58: Internal Surfaces Cabinet Cleaning Ifu (Instructions For Use)

    RotaScope iQ Cabinet 3.4.1 Internal Surfaces Cabinet Cleaning IFU (Instructions For Use) Cleaning of the RotaScope 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 59: Cleaning External Surfaces

    RotaScope iQ 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 60: Safe Disposal

    RotaScope iQ 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.

  • Page 61: Terms And Definitions Used In This Manual

    RotaScope iQ Cabinet 3.5 Terms and definitions used in this manual Term Meaning A 9V Battery – Used to manually unlock cabinet 9V Battery doors in case of power failure – battery may be inserted into the battery compartment located under the Cabinet Control Screen on the cabinet door –...
  • Page 62 RotaScope iQ Cabinet handpiece and should be positioned for easy scanning when the scope is Loaded. The barcode will be seen by the system and identifies the Scope Name (E.g. New Scope), ID Number (E.g. Serial number), and Type (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...
  • Page 63 RotaScope iQ Cabinet • AER Chamber Barcode Sticker (4 Scans) A barcode is printed for each staff member – the barcode should be affixed to a staff badge or lanyard – the barcode will be seen by the system Barcode – Staff ID and identifies the staff name when recorded against a process –...
  • Page 64 RotaScope iQ Cabinet to a scope channel colour coded hoses with specialized fitting are used and connect to the scope ports – see Scope Ports RotaScope Cabinets are manufactured and set up in accordance with EN16442:2015 Standards, however local endoscopy or sterile area guidelines may provide additional recommendations or limitations on use of drying cabinets.
  • Page 65 RotaScope iQ Cabinet RotaScope IQ Cabinets are manufactured and tested in accordance with EN16442 Standards and are validated to store endoscopes for a duration of up to 31 Days Allowable Storage Time may also be dependent on local guidelines and should be considered by your HSO policy.
  • Page 66 RotaScope iQ Cabinet The HEPA Filter must be replaced annually by an Authorised Distributor at Annual Service Each stored endoscope needs to be connected to the cabinet airflow system, so that the scope channels (Lumens) are dried internally RotaScope Cabinets require a Hose Connection Kit Hose Connection Kits to be purchased for each type of scope stored The colour coded hoses have a Luer fitting on one...
  • Page 67 RotaScope iQ Cabinet scope is loaded into the cabinet – OOC Countdown resumes when a scope is taken out of a cabinet to be moved or used, and if the scope is returned to the cabinet the countdown is deducted from remaining OOC time and displayed on the Main Cabinet Control Screen.
  • Page 68 RotaScope iQ Cabinet error occurs – usually the router is located on or near the cabinets Also called “Vacuum Hoses” or “Hose Kits” Colour coded hoses with connection fittings – used Scope Connector Hose to connect the cabinet airflow to various channel Kits connection fittings of an endoscope, to dry endoscope lumens.

  • Page 69: Graphical Symbols

    RotaScope iQ Cabinet 3.6 Graphical Symbols 3.6.1 Explanation of graphical 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 RCM Compliance Batch Number Recorded ROHS Compliance Serial Number Recorded...

  • Page 70: Personal Protective Equipment

    RotaScope iQ 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

    RotaScope iQ 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

    RotaScope iQ Cabinet 4.1.1 Dimensions, mass and center of gravity Cabinet Body 600mm Wide x 600mm Deep x 2363mm High including 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 High.

  • Page 73: Lifting, Handing And Transporting The Product

    RotaScope iQ 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

    RotaScope iQ 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

    RotaScope iQ 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: Free Standing Cabinet Wall Mount

    RotaScope iQ Cabinet 4.2.2 Free Standing Cabinet Wall Mount Single Door cabinets require the top of the cabinet to be mounted to the wall to ensure stability. The supplied bracket should be mounted to the top of the cabinet and secured to the wall, preferably into solid structure or stud. See below. 4.2.3 Pass Through Units If specifically ordered, Pass-Through cabinets may be supplied with a rear door,...
  • Page 77 RotaScope iQ Cabinet Cabinet Front located in the Reprocessing Room Cabinet Rear seen in the Procedure Room Manual Version 1.04 Date 23 November 2021...

  • Page 78: Power Connection

    RotaScope iQ 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 4.2.4 Power Connection: 1.

  • Page 79: Verification Of The Product

    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 Operational Qualification (IQ & OQ) in accordance with EN16442 and AS4187 or local standard.

  • Page 80: Minimum Space Needed

    RotaScope iQ Cabinet 4.2.7 Minimum space 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. See diagram below. Passthrough models require 1800mm deep.

  • Page 81: Layout Plan

    RotaScope iQ Cabinet 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 installation for each site. Fig. 5 – Example Layout Plan Manual Version 1.04 Date 23 November 2021...

  • Page 82: Data And Power Schematic

    RotaScope iQ Cabinet 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 Manual Version 1.04 Date 23 November 2021...

  • Page 83: Required Tools

    RotaScope iQ Cabinet 4.2.10 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 84: Operation/Use Verification

    RotaScope iQ 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 85: Starting/Stopping The Product Operation

    RotaScope iQ Cabinet Image above shows use of the “Hard Reset Button”, located behind the façade at the top front of the RotaScope 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 86: Maintenance

    RotaScope iQ Cabinet 6 MAINTENANCE The RotaScope shall only be maintained by a qualified and trained Authorised Distributor How to Maintain the Product 6.1.1 Planned maintenance of RotaScope. Maintenance tasks shall be done according to the following plan: Task Frequency Replace the Intake Filter Every 12 months Replace HEPA Filter...

  • Page 87: Troubleshooting And Repair

    RotaScope iQ Cabinet 7 TROUBLESHOOTING AND REPAIR All repairs should be done by an Authorised Distributor. 7.1 How to Identify and Solve Problems 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 Authorised Distributor and a service technician will be in contact to troubleshoot or attend your site if required.

  • Page 88: Frequently Asked Questions

    RotaScope iQ 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 89: Disposal

    RotaScope iQ 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 e.g. Cabinet Body b) Remove Aluminum Doors and Discard Door Seals –...

  • Page 90: How To Recycle Parts

    RotaScope iQ 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 91: Disposal Of The Device

    RotaScope iQ 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 92: Disposal Of Batteries

    RotaScope iQ Cabinet 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. Batteries may not be disposed of with the usual domestic waste.

  • Page 93: Appendix I - Supplied Accessories, Consumables And Spare Parts

    RotaScope iQ Cabinet 9 APPENDIX I – SUPPLIED ACCESSORIES, CONSUMABLES AND SPARE PARTS 9.1 Supplied accessories Image Name Hose Connection Kits Various Communication Kit COMMUNICATION KIT Labels 9.2 Consumables Image Name Part Number Luer Filters HOSEKIT FILTER Tip Protector TIP PROTECTORS See Authorised Channel Separators Distributor...
  • Page 94 RotaScope iQ 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...
  • Page 95 RotaScope iQ Cabinet Cabinet pressure monitor in IAS 48.SC-SY-HTS Data Switch/power pack in IAS 48.DGS-1008A Channel Monitor Board – in Vacuum CHAN MON SENSOR Manifold BOARD Channel Monitor Data Board – in CM-RX-Rota RotaScope Pole (Circular) Door Lock/Latch – in door frame LOCK SOLENOID Door Cabinet Control Blister Assembly –...
  • Page 96 RotaScope iQ Cabinet CR2032 Battery Contact Smartline Manual Version 1.04 Date 23 November 2021...

  • Page 97: Declaration Of Conformity For Class Idevice

    Unique identification number of this Document: See Document no. F-218 V1 Manufacturer Detail 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 98 RotaScope iQ Cabinet CE Declaration of Conformity 2021: P1 Manual Version 1.04 Date 23 November 2021...
  • Page 99 RotaScope iQ Cabinet CE Declaration of Conformity 2021: P2 Manual Version 1.04 Date 23 November 2021...

  • Page 100: Related Documentation

    RotaScope iQ Cabinet 11 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 1.04 Date 23 November 2021...

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