MEDICSIGHT MEDICCO2LON User manual

User Manual
Issue 1.16

2Copyright © 2020 Ultrasound Technologies Ltd
2
CONTENTS
1. BACKGROUND 4
2. COPYRIGHT and DISCLAIMER 5
3. INTRODUCTION 6
3.1 Intended Use 6
3.2 Contraindications 6
3.3 Safety Features 7
3.4 Operating Practice 8
3.5 General Warnings and Cautions 8
3.6 Symbol Definitions 12
3.7 Unpacking and Inspection of Equipment 13
3.7.1 Unpacking the system 13
4. INSTALLATION and SETUP 14
4.1 Assembly and Installation 14
4.1.1 Front Panel 14
4.1.2 Rear Panel 15
4.1.3 Insufflator Device Preparation 16
4.1.4 CO2Gas 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 MEDICCO2LON 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. MEDICCO2LON DEVICE WORKFLOW 22
5.1 Shut-Down Procedure 23
5.2 Detailed description of Main Screen 24
5.2.1 Actual Indicator Bar 25
5.2.2 SD Card Status Indicator 26
6. MAINTENANCE 27
6.1 Troubleshooting Guide 27
6.2 Cleaning and Sterilisation Precautions 28

3
Copyright © 2020 Ultrasound Technologies Ltd 3
CONTENTS
6.3 Cleaning, Sterilisation and Storage 29
6.4 Repairs and Returns 29
6.5 Ordering Information 30
7.1 MEDICCO2LON Device 31
7.2 Administration Set 31
7. EQUIPMENT SPECIFICATION 31
7.4 EMC Tables 32
8. WARRANTY 36
9. WEEE and ROHS 38

4Copyright © 2020 Ultrasound Technologies Ltd
4
MedicCO2LON 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 MedicCO2LON Administration set is a
single use insufflation administration set designed to be used with the MedicCO2LON CO2
insufflator. It allows gas supplied from the control unit to be administered to the patient.
MedicCO2LON is not a blood-contacting device and does not control any life-sustaining
devices. Typical users of MedicCO2LON are trained medical professionals, including but
not limited to radiologists, clinicians, technologists and other health professionals.
MedicCO2LON is designed and manufactured for Medicsight Inc. by Ultrasound
Technologies Ltd.
1. BACKGROUND

5
Copyright © 2020 Ultrasound Technologies Ltd 5
2. COPYRIGHT and
DISCLAIMER
The information contained within this document is not contractually binding in nature
and is subject to change without prior notice.
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.
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 without the prior written consent of Medicsight.
Copyright © 2020 Medicsight Inc / Ultrasound Technologies Ltd
ALL RIGHTS RESERVED.
MEDICCO2LON™ is a trademark of Medicsight Inc.

6Copyright © 2020 Ultrasound Technologies Ltd
6
This user manual provides instructions for the operation of the MedicCO2LON, CT
Colonography CO2colonic insufflator, hereafter referred to as MedicCO2LON.
It is recommended that personnel study this manual before attempting to operate
the MedicCO2LON 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.
3.1 Intended Use
The MedicCO2LON device is intended to be used for colonic distension with CO2gas
for CT colonography procedures. The device should only be used for CT colonography
procedures and should not be used for any other patient examination procedure.
MedicCO2LON is designed to function with specific colonic insufflation administration
sets that allow passage of gas from the device to the colorectal cavity. MedicCO2LON
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 MedicCO2LON device, including single use administration sets, must only be used
for colonic insufflation for CT colonography and is contraindicated for use with other
examinations.
The MedicCO2LON device must not be used for patients with a colostomy stoma.
Use of the MedicCO2LON device for colonic distension is contraindicated whenever CT
colonography is contraindicated.
The relevant contraindications or conditions that require caution when using the
MedicCO2LON device include:
• Known or suspected colonic perforation.
• Recent deep endoscopic biopsy or polypectomy/mucosectomy.
• Recent rectal surgery.
• Symptomatic acute colitis/proctitis.
• Acute diarrhoea.
3. INTRODUCTION

7
Copyright © 2020 Ultrasound Technologies Ltd 7
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 MedicCO2LON device, is not indicated for:
• Routine follow-up of inflammatory bowel disease.
• Hereditary polyposis or non-polyposis cancer syndromes.
• Evaluation of anal canal disease.
• The pregnant or potentially pregnant patient.
3.3 Safety Features
The following safety features regulate the operation of the device:
• Once power supply to the unit is turned on, the Start icon must be activated
before CO2flow will commence.
• Pressing the Stop icon at any time during CO2flow 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 continues until the target pressure is re-attained.
• If the pressure exceeds 50mm Hg, an electrical relief valve is activated and an
audible alarm will sound. Additionally the pressure display will turn red.
• A mechanical override pressure relief valve is activated when pressure exceeds
78mm Hg. This override valve is independent of the electronic system controls.

8Copyright © 2020 Ultrasound Technologies Ltd
8
3.4 Operating Practice
The MedicCO2LON device administers CO2with 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 CO2is administered to the patient to reach the target colonic
pressure pre-set by the user. The user can monitor colonic pressure with the Pressure
Display on the front panel of the unit. When maximum flow rate has been reached the
device continuously monitors actual colonic pressure.
The MedicCO2LON device has an electronically controlled Pressure Relief Valve activated
at 50mm Hg and an independent redundant mechanical Pressure Relief Valve pre-set to
78 mm Hg. Both pressure relief safety devices are active whether the Gas Flow is on or off.
3.5 General Warnings and Cautions
Users should be familiar with and adhere to all warnings, cautions and instructions for
use that are labelled on the MedicCO2LON device and included in the MedicCO2LON User
Manual.
• TheMedicCO2LON 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.
• TheMedicCO2LON device should not be used in the presence of flammable
anaesthetic mixtures; with air; with oxygen or with nitrous oxide.
• TheMedicCO2LON device has not been tested for compatibility with Magnetic
Resonance Imaging (MRI) equipment and should not be introduced to an MRI
scanning room.
• TheMedicCO2LON device has not been tested for paediatric use and should not
be used for paediatric CT colonography examinations.
• RegularperiodicmaintenanceoftheMedicCO2LON device is recommended and
as a minimum should be undertaken annually.
• Itisrecommendedthatthemechanicalpressurereliefvalveisreplacedduring
periodic maintenance, to ensure continued safe operation of the device.
• PrecautionsforEMCsafetyshouldbeobserved.TheMedicCO2LON Insufflator
3. INTRODUCTION

9
Copyright © 2020 Ultrasound Technologies Ltd 9
3. INTRODUCTION
complies with IEC60601-1-2:2015, however:
o Electronic equipment in the vicinity of the MedicCO2LON device may affect
its operation and potentially cause unpredictable operation of the device.
o Wherever possible the MedicCO2LON device should be distanced from
surrounding electromagnetic equipment and cables to this equipment in
order to reduce possible electromagnetic interference.
o The MedicCO2LON device is not approved for connection to any other device
• Shouldtheelectricalsafetyfuseshavetobereplaced,useonlyfusesofthetype
and rating defined on the rear label of the unit and in the Device Specification.
• Whenpositioningtheunit,ensurethataccessisavailabletothe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
shock. All service requirements should be referred to a MedicCO2LON authorised
representative.
• Neverattempttoserviceanypartofthedevicewhenconnectedtothepatient.
Disconnect and remove from patient environment before servicing.
• Allequipmentshouldbethoroughlycleanedaftereachuse(refertosection6.3
Cleaning, Sterilisation and Storage).
WARNING: Do not modify this equipment without authorization of the manufacturer.
WARNING: To avoid the risk of electric shock this equipment must only be connected to
a mains supply with a protective earth.

10 Copyright © 2020 Ultrasound Technologies Ltd
10
General Warnings and Cautions - Use of CO2Gas
• TheprovisionofCO2for use with the MedicCO2LON device should only be
from a Medical Grade CO2cylinder. Use only “Medical Grade” CO2available 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.
• RegularchecksshouldbeundertakentoensurethatallCO2gas connections are
correctly installed and have no visible damage.
• TheMedicCO2LON device can release CO2to the surrounding atmosphere in the
event of misuse or the machine developing a fault. The MedicCO2LON device
should therefore be stored in a well ventilated environment. In the event of any
discharges of CO2there should be immediate evacuation of the area until it has
been sufficiently ventilated.
• Gaslineconnectionsshouldbecheckedtoverifyasecureconnectionpriorto
opening the gas source(s) as faulty or insecure connections could cause forceful
separation that may cause serious injury.
3. INTRODUCTION

11
Copyright © 2020 Ultrasound Technologies Ltd 11
3. INTRODUCTION
General Warnings and Cautions - Introduction of CO2
• AirEmbolismHazard:airshouldbepurgedfromtheadministrationsettubing
and instruments with 0.2 litres of CO2prior to introduction of the catheter and
gas to the patient.
• IrritationHazard:infusionofCO2can result in carbonic acid irritation to tissues
that come into direct contact with the CO2.
• Systemoperatorsshouldalwaysinstructthepatienttonotifythemshouldthey
feel any pain during the procedure.
• InrarecircumstancesaccidentalintravasationofCO2occur 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CO2may result from an excessive flow rate and/or
excessive pressure. The colon can be adequately distended by pressure in the
range of 20-30 mm Hg. Use of pressure ≤ 25 mm Hg will dramatically reduce the
likelihood of intravasation of CO2gas.
• Idiosyncraticreactions:patientswithsicklecelldiseaseorpulmonary
insufficiency may be at increased risk of metabolic imbalance in relation to
excessive CO2absorption.

12 Copyright © 2020 Ultrasound Technologies Ltd
12
3.6 Symbol Definitions
The following list and table contains abbreviations and symbols for terms and icons
commonly used throughout this manual:
AC Alternating Current
EO Ethylene Oxide
CO2Carbon Dioxide Gas
Hz Hertz
kPa Kilopascal
LLitre (or Litres)
LPM Litre(s) Per Minute
mm Hg Millimetres of Mercury
PSI Pounds per Square Inch
PU Polyurethane
VVolt
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
CO2Gas Input
CO2Gas Output
Interference may occur in the vicinity of equipment marked with
the following symbol.
EC Authorised Representative.
3. INTRODUCTION
!

13
Copyright © 2020 Ultrasound Technologies Ltd 13
3. INTRODUCTION
3.7 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 MedicCO2LON device to avoid inadvertent damage.
Examine the shipping carton and instrument for signs of damage. Any breakage or other
apparent damage should be noted, the evidence retained, and the carrier or shipping
agency notified.
Verify that the shipping carton contains the following items:
• MedicCO2LON 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 immediately if any damage or discrepancies are
noted.
3.7.1 Unpacking the system
Unpack the MedicCO2LON device on a flat surface away from liquid sources.
• Inspecttheinsufflatordeviceforsignsofdamage.Damagedequipmentshould
not be used and should be returned to the distributor representative for repair or
replacement.
• Atrolleyisavailableasanaccessorywhichwillbeinstalledbyanapplication/
clinical or sales representative.

14 Copyright © 2020 Ultrasound Technologies Ltd
14
4.1 Assembly and Installation
The MedicCO2LON 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.
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 (CO2output).
4. INSTALLATION and
SETUP

15
Copyright © 2020 Ultrasound Technologies Ltd 15
4.1.2 Rear Panel
7 6
1 2 3 4 8 5
1. Mains power and system On/Off switch.
2. Fuse drawer.
3. Mains input connection.
4. CO2gas input connection.
5. SD card slot.
6. Product EAN Datamatrix for product identification.
7. Product Serial Number: Product Type / Manufactured Date (Year Month) -
Sequential 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 use this
instrument in the
1639
MADE IN THE UK
MC2G101-107
SN
CO
2
!
BS / IEC Class 1
(01) 5060337640169
presence of flammable
gases.

16 Copyright © 2020 Ultrasound Technologies Ltd
16
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
MedicCO2LON 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 CO2Gas Connections
Connecting the Regulator to the Cylinder
Medical Grade gases are supplied in cylinders that are fitted 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.
MedicCO2LON 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-clockwise.
2. Connect the regulator to the cylinder using the spanner provided and securely
tighten.
3. Attach the connection tube supplied to the outlet connection and attach the
other end of the tube to the CO2input connection on the MedicCO2LON device.
4. Slowly open the gas cylinder valve. A leaking valve can be identified by listening
for any seepage sound. A leaking valve should be reported immediately as it can
be a serious safety issue.

17
Copyright © 2020 Ultrasound Technologies Ltd 17
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 MedicCO2LON device.
4. Slowly open the gas cylinder valve. A leaking valve can be identified by listening
for any seepage sound. A leaking valve should be reported immediately as it can
be a serious safety issue.
4.1.5 Gas Supply Indicator
The main screen displays a gas supply indicator. The levels displayed are a guide to
determine whether there is sufficient gas in the CO2cylinder to perform a procedure.
Cylinder contains sufficient CO2for
multiple procedures.
Unit will begin procedure and supply
CO2as required.
Cylinder CO2level is low, may not
complete multiple procedures.
Unit will supply CO2as required.
Cylinder CO2level too low to complete
procedure, change cylinder.
Unit will not begin procedure or supply
CO2.
Cylinder is empty or supply not
connected to unit. Check cylinder
connection or change cylinder.
Unit will not begin procedure or supply
CO2.
ATTENTION: The unit will not function if the gas supply indicator is empty.
WARNING: Do not allow liquid CO2to enter the unit. This can be prevented by
ensuring the CO2cylinder remains upright at all times.
4. INSTALLATION
and SETUP

18 Copyright © 2020 Ultrasound Technologies Ltd
18
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 MedicCO2LON 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 MedicCO2LON to store insufflation data for maintenance
and research purposes. Insufflation data is automatically Date and Time stamped
allowing 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 MedicCO2LON device is switched off before inserting or
removing the SD card.
4.2 Programming the MEDICCO2LON System for Use
Following powering on the unit and initial setup, users can either proceed with
an examination using the pre-programmed default settings or set individual user
preferences on the ‘Workflow’ Setup Screen (see Section 4.3).
4.2.1 Initial Setup
The‘start-up’setup screen allows the user to set the MedicCO2LON interface language

19
Copyright © 2020 Ultrasound Technologies Ltd 19
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).
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 Time and Date
4. INSTALLATION
and SETUP

20 Copyright © 2020 Ultrasound Technologies Ltd
20
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.
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 deactivates the automatic volume stop.
5. Accept/Decline: Accept or decline the setup changes.