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MEDICSIGHT MEDICCO2LON, User Manual

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MEDICSIGHT MEDICCO2LON User Manual Download Page 4

4

Copyright © 2020 Ultrasound Technologies Ltd

4

MedicCO

2

LON is an automated insufflation device designed for administering and 

regulating colonic distension by insufflation with carbon dioxide gas, in preparation for 

and during a CT colonography examination. The MedicCO

2

LON Administration set is a 

single use insufflation administration set designed to be used with the MedicCO

2

LON CO

2

 

insufflator. It allows gas supplied from the control unit to be administered to the patient.

MedicCO

2

LON is not a blood-contacting device and does not control any life-sustaining 

devices.  Typical users of MedicCO

2

LON are trained medical professionals, including but 

not limited to radiologists, clinicians, technologists and other health professionals.

MedicCO

2

LON is designed and manufactured for Medicsight Inc. by Ultrasound 

Technologies Ltd.

1. BACKGROUND

Summary of Contents for MEDICCO2LON

Page 1: ...User Manual Issue 1 16 ...

Page 2: ...4 1 1 Front Panel 14 4 1 2 Rear Panel 15 4 1 3 Insufflator Device Preparation 16 4 1 4 CO2 Gas Connections 16 4 1 5 Gas Supply Indicator 17 4 1 6 Administration Set Connection 18 4 1 7 SD Card 18 4 2 Programming the MEDICCO2 LON System for Use 18 4 2 1 Initial Setup 18 4 3 Detailed Description of Workflow Setup Screen 20 4 3 1 Workflow Setup 21 5 MEDICCO2 LON DEVICE WORKFLOW 22 5 1 Shut Down Proce...

Page 3: ...td 3 CONTENTS 6 3 Cleaning Sterilisation and Storage 29 6 4 Repairs and Returns 29 6 5 Ordering Information 30 7 1 MEDICCO2 LON Device 31 7 2 Administration Set 31 7 EQUIPMENT SPECIFICATION 31 7 4 EMC Tables 32 8 WARRANTY 36 9 WEEE and ROHS 38 ...

Page 4: ...on administration set designed to be used with the MedicCO2 LON CO2 insufflator It allows gas supplied from the control unit to be administered to the patient MedicCO2 LON is not a blood contacting device and does not control any life sustaining devices Typical users of MedicCO2 LON are trained medical professionals including but not limited to radiologists clinicians technologists and other healt...

Page 5: ... 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 This document contains proprietary information which is protected by copyright All rights are reserved No part of this document may be copied reproduced or transmitted by any means whatsoever ...

Page 6: ...inistration sets that allow passage of gas from the device to the colorectal cavity MedicCO2 LON should only be used with administration sets specifically designed for this purpose The device should only be used by personnel trained in the practice of undertaking CT Colonography examinations and the use of an automatic insufflation device 3 2 Contraindications The MedicCO2 LON device including sin...

Page 7: ...r supply to the unit is turned on the Start icon must be activated before CO2 flow will commence Pressing the Stop icon at any time during CO2 flow will stop the gas flow Users can pre set the target pressure up to 30mm Hg When the pre set target pressure is exceeded by 10 for more than 5 0 seconds pressure is relieved by the automatic activation of a pressure release valve Pressure release contin...

Page 8: ... and included in the MedicCO2 LON User Manual The MedicCO2 LON device and associated equipment are designed for use by personnel trained in the practice of undertaking CT colonography examinations and the use of an automatic insufflation device All personnel should be thoroughly familiar with the operation of the device prior to use and should follow good clinical practice when using the device Th...

Page 9: ...e mains On Off switch and power cable located on the rear of the unit Fluids should not be allowed to enter the device as this may result in damage to the system User should be aware of the status of unit at all times during the procedure Only qualified personnel should service the device and the unit cabinet should not be opened except by these personnel due to the risk of hazardous electrical sh...

Page 10: ...ndertaken to ensure that all CO2 gas connections are correctly installed and have no visible damage The MedicCO2 LON device can release CO2 to the surrounding atmosphere in the event of misuse or the machine developing a fault The MedicCO2 LON device should therefore be stored in a well ventilated environment In the event of any discharges of CO2 there should be immediate evacuation of the area un...

Page 11: ...tances accidental intravasation of CO2 occur and can result in embolisation In cases of emergency the operator should terminate gas flow by disconnecting the administration set from the gas output port Prolonged intra colon pressures greater than 25 mm Hg should be avoided as this can cause patient discomfort Excessive absorption of CO2 may result from an excessive flow rate and or excessive press...

Page 12: ...Litre or Litres LPM Litre s Per Minute mm Hg Millimetres of Mercury PSI Pounds per Square Inch PU Polyurethane V Volt VA Volt ampere Attention Caution Warning Refer to User Manual Power ON Power OFF Type B equipment Insufflator Electrical Shock Hazard Dangerous Voltage Waste Electrical and Electronic Equipment WEEE Directive CO2 Gas Input CO2 Gas Output Interference may occur in the vicinity of eq...

Page 13: ...ined and the carrier or shipping agency notified Verify that the shipping carton contains the following items MedicCO2 LON Insufflator unit User Manual High Pressure Regulator for CO2 Low Pressure connection tube for connection from High Pressure Regulator to insufflator Spanner for attaching High Pressure Regulator Power Cable Administration Sets as ordered Notify the distributor representative i...

Page 14: ...sentative 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 WARNING Equipment not suitable for use in presence of a flammable anaesthetic mixture with air or Oxygen or Nitrous Oxide 4 1 1 Front Panel 1 2 1 Touchscreen display 2 Administration set connection CO2 output 4...

Page 15: ...equential Number 8 Label Part Number Part Number Issue Number 4 INSTALLATION and SETUP AC line input 100 240V 50 60Hz 40VA T3 15AH Manufactured by Ultrasound Technologies Ltd Lodge Way Caldicot NP26 5PS South Wales United Kingdom CAUTION Do not remove covers No user serviceable parts inside refer servicing to qualified personnel Replace fuses with same type and rating 1 5 2 0 Bar WARNING Do not us...

Page 16: ...tted with delivery valves There are two popular versions of valve PIN Index often used as the preferred valve for Medical Grade gases Bull Nose common in industrial and laboratory applications MedicCO2 LON is supplied with a Pressure Regulator that can be connected to a Bull Nose valve directly To connect Bull Nose valve cylinders 1 Close the regulator by rotating the valve handle counter clockwis...

Page 17: ...gas supply indicator The levels displayed are a guide to determine whether there is sufficient gas in the CO2 cylinder to perform a procedure Cylinder contains sufficient CO2 for multiple procedures Unit will begin procedure and supply CO2 as required Cylinder CO2 level is low may not complete multiple procedures Unit will supply CO2 as required Cylinder CO2 level too low to complete procedure cha...

Page 18: ...llowing each procedure to be identified Insert the SD card into the slot on the rear of the device 5 and push until the card Clicks into place Press until the card Clicks and release to eject the card from the device The status of the SD card is shown on the Main Screen see section 5 2 2 ATTENTION Ensure the MedicCO2 LON device is switched off before inserting or removing the SD card 4 2 Programmi...

Page 19: ...and to the time and date menu 3 1 To change language select the desired language icon 1 and accept the changes 2 to restart the device in the chosen language 2 Press the decline icon 3 to exit the without changing language WARNING When the Japanese language is selected the language select screen is disabled To reactivate the language select screen please contact your service representative 4 2 1 2...

Page 20: ...n 3 to return without saving changes 4 3 Detailed Description of Workflow Setup Screen 1 Target Pressure Icons Current default target pressure parameters 2 Target Pressure Display Numerical display of selected Target Pressure Value to be stored as a new default parameter 3 Increment Decrement Icons Increases or decreases the value on the target pressure display 4 Volume Stop Activates or deactivat...

Page 21: ... 6 8 and 10L once a volume stop level is reached the unit will stop insufflating and an alarm will be sounded Press the resume icon to continue insufflating 1 Select the setup icon on the main screen 2 Press the volume stop icon to activate or deactivate 4 Active Inactive 3 Press the accept icon to confirm and exit the setup screen 4 Press the decline icon to exit without saving changes N B The cu...

Page 22: ... base of the retention balloon is just beyond the anorectal junction 7 Inflate the catheter balloon if determined necessary N B After insertion of the catheter a discharge of fluid from the colon may be noticed Assure that the effluent is completely drained and captured in the effluent trap before proceeding 8 Start the process of gas insufflation by pressing START 9 During insufflation the start ...

Page 23: ... silenced by selecting the stop icon 14 To reset the volume display and open the gas relief valves hold the RESET icon for two seconds The indication of the total CO2 volume used reverts to 0 0L All other internal parameters related to the process are returned to default settings N B The reset icon is inactive during insufflation 5 1 Shut Down Procedure ATTENTION Ensure the CO2 cylinder valve is c...

Page 24: ...cons 3 Pressure Display Displays the actual colonic pressure in mmHg during insufflation 4 Actual Pressure Indicator Bar Actual colonic pressure value as measured is displayed by a four stage bar chart see section 5 2 1 5 Flowrate Display Displays current actual flowrate 6 Actual Flow Indicator Bar Actual flow value as measured is displayed by a four stage bar chart see section 5 2 1 7 Gas Volume ...

Page 25: ...te at a predefined value 5 2 1 Actual Indicator Bar The Actual Indicator Bar provides an additional visual guide for the progress of the pressure and flowrate during insufflation and notifies the user when the safety features are in operation 5 2 1 1 Actual Pressure Indicator Bar The bar has four cells to indicate the progress of the insufflation Indicator Stage No gas pressure Insufflation proces...

Page 26: ...re ATTENTION The red cell will only be displayed if a system error is observed please contact your distribution representative if this occurs 5 2 2 SD Card Status Indicator The indicator has 4 states indicating the current status of the SD card Indicator Status No SD card present SD card present and working correctly SD card error SD card full When the SD card is present and working correctly proc...

Page 27: ...ak in CO2 supply tubing connections to unit 1 Check and tighten connections at the cylinder and MedicCO2 LON device 2 Should checking 1 fail to rectify the problem call CO2 Supplier or distributor representative for service No flow of CO2 Cylinder is empty 1 Check the Actual Flow Indicator Bar for positive flow of gas 2 Check the supply indicator the unit will not function if the cylinder is empty...

Page 28: ...fied Internal fault or failure 1 Power unit OFF ON 2 Should checking 1 fail to rectify the problem contact the distributor representative SD card error SD card full indicator displayed SD card corrupted or full 1 Power unit OFF and Eject the SD card 2 Replace with a new SD card SDSC cards only available from distributor 3 Power unit On 3 Should checking 1 and 2 fail to rectify the problem contact ...

Page 29: ...overed and stored in a cool dry location Care should be taken to avoid rough handling jarring or dropping the unit 6 4 Repairs and Returns If a customer deems that repair is necessary for the MedicCO2 LON device please contact the Distributor representative for further details on the returns policy Repair costs are covered during the warranty period Customers are advised to contact Distributor rep...

Page 30: ...ment of necessary parts or b Authorise or pay for return shipment via a carrier authorised to handle bio hazardous material or c Authorise and pay for proper disposal of the MedicCO2 LON device Please refer to the Warranty for full terms and conditions 6 5 Ordering Information To find out more about the MedicCO2 LON Insufflator or to place an order for a unit or disposables please contact your dis...

Page 31: ...curacy Electronic Valve 50mmHg or 10 of Target Pressure for 5 seconds 1 mmHg Mechanical Valve 1 5psi 78mmHg nominal 20 Physical Size 235 mm x 160 mm x 180 mm width x height x depth Weight 2 0 Kg Data Presentation 150mm x 90mm LED Backlit LCD with Resistive Touch Interface CO2 Supply CO2 Supply Pressure 1 5 2 0 Bar Regulated Gas Supply Single C or D size CO2 cylinder Electrical Power Supply AC Inpu...

Page 32: ...mpatibility and should not be introduced into a MR examination suite 7 4 EMC Tables Table 1 Guidance and Manufacturer s Declaration Electromagnetic Emissions The MedicCO2 LON device is intended for use within the electromagnetic environment specified below The customer or the operator of the MedicCO2 LON device should ensure that it is only used within such an environment Emissions Test Compliance...

Page 33: ...0 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Voltage dips short interrupt...

Page 34: ...n meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagat...

Page 35: ...requency of Transmitter m Read Maximum Output Power of Transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz W d 1 2 P d 1 2 P d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 3 8 3 8 7 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distances d in meters m can be estimated using the equation applicable to the ...

Page 36: ...ANTY 1 This Warranty shall not apply to the defects arising in Ultratec s opinion by reason of accident alteration abuse misuse neglect improper installation unauthorized repairs replacement of original parts riots fire floods or other acts of god Charges for repairs of this nature if carried out will have to be borne by the original purchaser 2 This Warranty remains effective only so long as ther...

Page 37: ...e effort to carry out repairs and or replacement of parts under this Warranty as soon as possible Ultratec shall not be liable to do so within any specific period of time 10 In the event of repairs and or replacement of any parts this Warranty will continue to remain in force only for the unexpired period of the Warranty 11 It is entirely left to Ultratecs discretion to effect repairs and or repla...

Page 38: ...ional implementing legislation Instructions for Disposal of Waste Equipment by Commercial Users This symbol on the product or on its packaging indicates that this product must not be disposed of with general waste For users of MedicCO2 LON equipment Ultrasound will provide free recycling of equivalent medical electronic equipment once a customer has returned the equipment to us with all transport ...

Page 39: ...39 Copyright 2020 Ultrasound Technologies Ltd 39 ...

Page 40: ...n 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 2020 Ultrasound Technologies Ltd Document Date 17 11 2020 EC REP MDSS GmbH Schiffgraben 41 30175 Hannover Germany ...

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