MEDICSIGHT MEDICCO2LON Manual de usuario

User Manual

Issue 1.16

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

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

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

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,

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.

MEDICCO2LON™ is a trademark of Medicsight Inc.

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

• 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.

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

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.

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

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