MEDICSIGHT MEDICCO2LON User Manual
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MEDICSIGHT MEDICCO2LON User Manual

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User Manual
Issue 1.16

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Summary of Contents for MEDICSIGHT MEDICCO2LON

  • Page 1 User Manual Issue 1.16...

  • Page 2: Table Of Contents

    CONTENTS 1. BACKGROUND 2. COPYRIGHT and DISCLAIMER 3. INTRODUCTION Intended Use Contraindications Safety Features Operating Practice General Warnings and Cautions Symbol Definitions Unpacking and Inspection of Equipment 3.7.1 Unpacking the system 4. INSTALLATION and SETUP Assembly and Installation 4.1.1 Front Panel 4.1.2 Rear Panel 4.1.3...
  • Page 3 CONTENTS Cleaning, Sterilisation and Storage Repairs and Returns Ordering Information MEDICCO LON Device Administration Set 7. EQUIPMENT SPECIFICATION EMC Tables 8. WARRANTY 9. WEEE and ROHS Copyright © 2020 Ultrasound Technologies Ltd...

  • Page 4: Background

    Typical users of MedicCO LON are trained medical professionals, including but not limited to radiologists, clinicians, technologists and other health professionals. MedicCO LON is designed and manufactured for Medicsight Inc. by Ultrasound Technologies Ltd. Copyright © 2020 Ultrasound Technologies Ltd...

  • Page 5: Copyright And Disclaimer

    This manual contains information deemed proprietary to Medicsight Inc (Medicsight). The information contained herein, including all of the designs and related materials, is the sole property of Medicsight and/or its licensors. Medicsight reserves all patent, copyright and other proprietary rights to this document, including all design, manufacturing methodology and reproduction.

  • Page 6: Introduction

    3. INTRODUCTION This user manual provides instructions for the operation of the MedicCO LON, CT Colonography CO colonic insufflator, hereafter referred to as MedicCO LON. It is recommended that personnel study this manual before attempting to operate the MedicCO LON device. The safe and effective use of this equipment requires understanding of and compliance with all warnings, cautionary notices, and instructions marked on the product, and included in this manual.

  • Page 7: Safety Features

    3. INTRODUCTION Recent acute diverticulitis. • Symptomatic colon-containing abdominal wall hernia. • Symptomatic or high-grade small bowel obstruction. • CT colonography, and therefore use of the MedicCO LON device, is not indicated for: • Routine follow-up of inflammatory bowel disease. •...

  • Page 8: Operating Practice

    3. INTRODUCTION Operating Practice The MedicCO LON device administers CO with an initial flow rate of 0.5 litre per minute (LPM) and the flow rate increases to a pre-set maximum of 3 - 4LPM. Colonic pressure gradually increases as CO is administered to the patient to reach the target colonic pressure pre-set by the user.
  • Page 9 3. INTRODUCTION complies with IEC60601-1-2:2015, however: o Electronic equipment in the vicinity of the MedicCO LON device may affect its operation and potentially cause unpredictable operation of the device. o Wherever possible the MedicCO LON device should be distanced from surrounding electromagnetic equipment and cables to this equipment in order to reduce possible electromagnetic interference.
  • Page 10 3. INTRODUCTION General Warnings and Cautions - Use of CO • The provision of CO for use with the MedicCO LON device should only be from a Medical Grade CO cylinder. Use only “Medical Grade” CO available in C or D supply cylinders. All instructions provided with the gas supply should be carefully understood and followed as failure to do so may result in serious injury to users or patients.
  • Page 11 3. INTRODUCTION General Warnings and Cautions - Introduction of CO • Air Embolism Hazard: air should be purged from the administration set tubing and instruments with 0.2 litres of CO prior to introduction of the catheter and gas to the patient. • Irritation Hazard: infusion of CO can result in carbonic acid irritation to tissues that come into direct contact with the CO • System operators should always instruct the patient to notify them should they feel any pain during the procedure.

  • Page 12: Symbol Definitions

    3. INTRODUCTION Symbol Definitions The following list and table contains abbreviations and symbols for terms and icons commonly used throughout this manual: Alternating Current Ethylene Oxide Carbon Dioxide Gas Hertz Kilopascal Litre (or Litres) Litre(s) Per Minute mm Hg Millimetres of Mercury Pounds per Square Inch Polyurethane Volt...

  • Page 13: Unpacking And Inspection Of Equipment

    3. INTRODUCTION Unpacking and Inspection of Equipment Appropriate care and maintenance of sophisticated medical equipment is essential for safe operation. Thorough inspection of all equipment upon receipt and prior to each use is recommended to safeguard against possible injury to patient or operator. This manual should be carefully studied prior to handling, assembling, testing, operating or cleaning a MedicCO LON device to avoid inadvertent damage.

  • Page 14: Installation And Setup

    4. INSTALLATION and SETUP Assembly and Installation The MedicCO LON device should be inspected before each use. Damaged equipment should be removed from service, reported to the distributor representative and returned as directed for repair or replacement. ATTENTION: If the unit performs abnormally at any time, remove the unit from service immediately and have it assessed and repaired.

  • Page 15: Rear Panel

    4. INSTALLATION and SETUP 4.1.2 Rear Panel Manufactured by: AC line input BS / IEC Class 1 Ultrasound Technologies Ltd 100 - 240V ~ Lodge Way,Caldicot, NP26 5PS 50 / 60Hz 40VA T3.15AH South Wales, United Kingdom MADE IN THE UK 1639 CAUTION: Do not remove covers.

  • Page 16: Insufflator Device Preparation

    4. INSTALLATION and SETUP 4.1.3 Insufflator Device Preparation Electrical Connections The following procedures should be performed before each use of the device: • Visually inspect the electrical connections. Do not use if inspection reveals any damage. • Connect the power cable to the power inlet connection on the back of the MedicCO LON device. • Ensure the main power switch is off and that the voltage is correct when connecting the power cord to the wall outlet. 4.1.4 Gas Connections Connecting the Regulator to the Cylinder...

  • Page 17: Gas Supply Indicator

    4. INSTALLATION and SETUP To connect PIN Index valve cylinders: 1. Close the regulator by rotating the valve handle counter-clockwise. 2. Align the adaptor yoke on the regulator to the PIN Index connection on the cylinder. 3. Attach the connection tube supplied to the outlet connection and attach the other end of the connection tube to the MedicCO LON device.

  • Page 18: Administration Set Connection

    4. INSTALLATION and SETUP 4.1.6 Administration Set Connection Attach an approved Administration Set, with a 0.1 micron hydrophobic filter to prevent cross contamination, to the MedicCO LON gas output on the bottom right of the front panel of the device. Refer to the Administration set directions for use for further details. 4.1.7 SD Card The SD card interface allows the MedicCO...
  • Page 19 4. INSTALLATION and SETUP and set the date/time. To access the ‘start-up’ setup screen press the icon in the corner of the ‘boot-up’ screen (1). 4.2.1.1 Language The setup screen gives access to language selection options and to the ‘time and date’ menu (3).

  • Page 20: Detailed Description Of 'Workflow' Setup Screen

    4. INSTALLATION and SETUP 1. The time and date can be modified using the increment and decrement icons adjacent to each value (1). 2. Press the accept icon (2) to save changes and return to the initial setup screen. 3. Press the decline icon (3) to return without saving changes. Detailed Description of ‘Workflow’...

  • Page 21: Workflow Setup

    4. INSTALLATION and SETUP 4.3.1 Workflow Setup The ‘Workflow’ setup screen allows the user to modify the default target pressure icons and activate or deactivate the automatic volume stop function. 4.3.1.1 Modify Pressure Target icons 1. Select the setup icon on the main screen. 2.

  • Page 22: Medicco Lon Device Workflow

    It is therefore important to verify correct operation of the unit before undertaking a procedure. 1. Turn on the power switch on the rear panel. 2. The MEDICSIGHT MEDICCO LON logo will appear on the screen, the main screen will automatically appear after 5 seconds.
  • Page 23 5. MEDICCO LON DEVICE WORKFLOW and the total gas volume shown on the display flashes. These indications signify that the first phase of CO insufflation is over. N.B – Volume stop must be activated for the above to occur. (see section 4.3.1.2) 12.

  • Page 24: Detailed Description Of Main Screen

    5. MEDICCO LON DEVICE WORKFLOW Detailed description of Main Screen 1. Target Pressure Preset Icons: Sets the target pressure at a predefined value, or modify using the increment/decrement icons. 2. Target Value Display: Displays selected target value. Press to display preset icons. 3.

  • Page 25: Actual Indicator Bar

    5. MEDICCO LON DEVICE WORKFLOW 9. SD Card: Indicates the status of the SD card. 10. Reset: Resets the MedicCO LON device. 11. Start/Resume/Stop icon. 12. Alarm: Toggles between two states - alarm enabled and alarm disabled. 13. ‘Workflow’ Setup: Activates the setup screen. 14.

  • Page 26: Sd Card Status Indicator

    5. MEDICCO LON DEVICE WORKFLOW 5.2.1.2 Actual Flow Indicator Bar The bar has four cells to indicate the progress of the insufflation. Indicator No flow of Flow of gas 50% of target Target flow Stage Flow error innitiated flow obtained achieved Whilst the target pressure in the colon is being maintained the unit may indicate no flow of gas, the flow will resume if the actual pressure is 10% less than the target pressure.

  • Page 27: Maintenance

    6. MAINTENANCE Troubleshooting Guide ATTENTION: Before using the Troubleshooting matrix below, operators should ensure that this manual has been fully read and understood. In cases of uncertainty in identifying an ‘Alarm Condition or Malfunction’ , pursuing a ‘Recommended Action’ or when unsuccessful in resolving an observed problem, operators should seek the assistance of a supervisor, or contact their distributor.

  • Page 28: Cleaning And Sterilisation Precautions

    6. MAINTENANCE Pressure Display • Actual pressure is 1. Unit will automatically vent to target pressure is red and alarm 50mmHg or higher within several seconds. Thereafter, alarm will sounds • Gas delivery line silence. blocked 2. Should pressure remain above target pressure, power unit down and disconnect Administration Set from unit.

  • Page 29: Cleaning, Sterilisation And Storage

    LON device can be wiped down with a damp cloth and mild germicide. Do not use abrasive materials or sharp edged devices when cleaning MedicCO2LON device. 3. No cleaning is required inside the unit. Do not allow water to enter the unit. Dry all components thoroughly.

  • Page 30: Ordering Information

    6. MAINTENANCE MedicCO LON device can only be repaired by Ultrasound Technologies where the customer shall either: a) Authorise the decontamination and replacement of necessary parts. b) Authorise or pay for return shipment via a carrier authorised to handle bio- hazardous material c) Authorise and pay for proper disposal of the MedicCO LON device.

  • Page 31: Administration Set

    7. EQUIPMENT SPECIFICATION MEDICCO LON Device Control EU/USA Version Japanese Version Target Pressure 5 - 30 mmHg selectable in 1mmHg steps Pressure Hold ±10% of Target Pressure Target Flow 1, 2, 3, 4 LPM selectable 1, 2, 3 LPM Flow Profile 0.5LPM per 0.5L delivered volume, up to target flow rate Volume 12L maximum delivery with optional volume stops at 4, 6, 8 and 10L...

  • Page 32: Emc Tables

    7. EQUIPMENT SPECIFICATION Length of catheter: Type I – 230mm (±5mm) and Type II – 410mm (±5mm) ATTENTION: The Administration Set is supplied non-sterile. Environmental Requirements Operating Ambient Temperature +10°C to +40°C Relative Humidity 30 – 70% non-condensing Ambient Pressure 700 kPa to 1060 kPa Transit and Storage Ambient Temperature -40°C to +70°C Relative Humidity 10% to 100%, including condensation...
  • Page 33 0.5 cycle for 0.5 cycle environment. If the operator power supply input 40% Ut (60% dip 40% Ut of the MedicCO2LON device lines IEC 61000-4-11 in Ut) (60% dip in Ut) requires continued operation for 5 cycles for 5 cycles...
  • Page 34 Test Level Level Guidance Portable and mobile RF communications equipment should be no closer to any part of the MedicCO2LON device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended Separation Distance...
  • Page 35 7. EQUIPMENT SPECIFICATION Table 4: Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the MedicCO LON device The MedicCO LON device is intended for use in the electromagnetic environment specified below. The customer or the user of the MedicCO LON device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the MedicCO...

  • Page 36: Warranty

    8. WARRANTY WARRANTY MedicCO 2 LON EQUIPMENT WARRANTY REGISTRATION Ultrasound Technologies Ltd (Ultratec) provides this Warranty only to the original Purchaser of the above equipment and all parts thereof (except consumables) (the “Equipment”), for a period of three calendar years (the “Term”) from the date of purchase on the terms set out below.
  • Page 37 8. WARRANTY Ultratec’ s employees, dealers or representatives have no authority to vary the terms of this Warranty. This Warranty does not create any contractual relationship between Ultratec and the Purchaser and the Purchaser buying the Equipment, must look to the performance of contractual obligations between itself and the dealer from whom the machine was bought.

  • Page 38: Weee And Rohs

    9. WEEE and ROHS Waste Electrical and Electronic Equipment (WEEE) Directive (2002/96/EC) There is an increasing interest in the proper disposal of used electronic equipment. The European Union (EU) has developed the WEEE (Waste Electrical and Electronic Equipment) Directive to ensure that systems for collection, treatment and recycling of electronic waste will be in place throughout the European Union.
  • Page 39 Copyright © 2020 Ultrasound Technologies Ltd...
  • Page 40 +44 (0) 1291 425425 Email service@doppler.co.uk Printed in United Kingdom Medicsight Inc reserves the right to modify this product specification without prior notice. Note that some options and functionalities might not be available on product release. Please confirm availability with our representative.

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