ML-G User Manual English

5/21/2018 ML-G User Manual English

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MGB Endoskopische Gerte GmbH Berlin * Schwarzschildstr. 6 * 12489 Berlin * GermanyTelephone 030-6392-7010 / -7014 * Telefax 030-6392-7011* E-mail: sales@ mgb-berlin.de * Internet: www.mgb-berlin.de

Operating Instructions

Gas Insufflator ML-G

Copyright 2012 MGB Endoskopische Gerte GmbH Berlin

Rev.2.0 / 06.12


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ML-GTable of contents

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Rev.2.0/06.12 1

Copyright Details

Copyright 2010 by MGB Endoskopische Gerte GmbH Berlin. All rights reserved.

This manual may not be photocopied, duplicated on microfilm or otherwise copied or

distributed, completely or in part, without prior written consent by MGB

Endoskopische Gerte GmbH Berlin (printed in Germany).

Table of Contents

1 Introduction ................................................................................................................... 2

2 Intended Use .................................................................................................................. 3

3 Safety ............................................................................................................................. 4

3.1 Safety Symbols ........................................................................................................... 4

3.2 Environmental conditions ............................................................................................ 6

3.3 Safety precautions ...................................................................................................... 6

4 Equipotential bonding connections ............................................................................. 8

5 Fuse replacement ........................................................................................................ 10

6 Customer service ........................................................................................................ 11

7 Warranty ....................................................................................................................... 12

8 Technical Specification ............................................................................................... 14

9 Installation ................................................................................................................... 15

9.1 Inspection upon delivery ........................................................................................... 15

9.2 System displays ........................................................................................................ 15

9.2.1 General .............................................................................................................. 15

9.2.2 Rear panel connections ...................................................................................... 16

9.2.3 Front panel ......................................................................................................... 16

9.2.4 Warning signals section ..................................................................................... 17

9.2.5 Pressure monitoring section ............................................................................... 17

9.2.6 Indicator for insufflation flow rate measured in l/min ........................................... 17

9.2.7 Insufflation monitoring and connection section ................................................... 18

9.3 Installation of power supply ....................................................................................... 18

9.4 Installation of CO2 bottle ............................................................................................ 19

9.5

Special installation .................................................................................................... 19

9.6 Calibration of pressure sensors zero value............................................................... 20

9.7 Function test after installation .................................................................................... 20

10 Operation ..................................................................................................................... 21

10.1 Preparing the device for operation ............................................................................ 21

10.2 Operating Steps ........................................................................................................ 21

10.3 Procedure after use .................................................................................................. 23

11 Maintenance ................................................................................................................. 24

11.1 Cleaning.................................................................................................................... 24

11.2 Functional Check List before each insufflation .......................................................... 2511.3 Troubleshooting ........................................................................................................ 26

11.4 Maintenance ............................................................................................................. 26


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ML-GIntroduction

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2 Rev.2.0/06.12

1 Introduction

Thank you for purchasing the MGB Endoskopische Gerte GmbH Berlin ML-G for

endoscopic procedures. This device has been scientifically designed and

manufactured to meet the highest standards required internationally for applicationsrelating to CO2 insufflation during endoscopic intra-abdominal surgery. Great care

was also taken in preparing the operating instructions and the service manual to

make both of them user-friendly, and to ensure that the specific procedures

pertaining to the device are easy to locate and follow.

To ensure safe operation and reliable long-term performance, it is essential that

users and service technicians fully understand the functions and procedures as well

as safety and maintenance instructions by reading the user manual thoroughly before

installing, using, cleaning or servicing the equipment. It is imperative that the staffwho handle the device first study and familiarise themselves with the entire manual

before attempting to use, clean, service or adjust this equipment or any associated

accessories. The safe and effective use of the equipment depends to a large extent

on factors under the control of the user and cannot be fully guaranteed by the design

of the equipment. It is important that the instructions contained in this manual are fully

understood and followed to ensure the safety of patients and users. Please pay

particular attention to all warnings, cautions, and notices in this manual.

We are always ready to assist you by answering any questions you may have or by

meeting your specific needs. We also welcome any comments you may have

regarding our equipment. Your comments and questions will receive immediate

attention. You can contact us via phone, mail, fax, or e-mail - see chapter "Customer

service" for details. For further information, please visit our website at www.mgb-

berlin.de.


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ML-GIntended use

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Rev.2.0/06.12 3

2 Intended Use

The Gas Insufflator ML-G (Article-No. 670-95600) is designed for insufflation of

medical grade CO2 gas during endoscopic intra-abdominal surgery. The micro

processor controlled measurement of the insufflation pressure and the actual static

intra-abdominal is brought by the fundamental system of the monofilar-bivalent-

system (MBS), an automatic pressure regulation system. The gas refill stream

regulates itself by measuring the actual intra-abdominal pressure through the same

opening. The intermittent electronic measurement provides consistency of gas

bubble size through regulation of the gas refill stream in case of gas loss.

ML-G controls the gas flow corresponding to the preselected static intra-abdominal

pressure in an optimized, physiologically tolerable speed. The operation of the Gas

Insufflator ML-G is confined to two manipulations: select the desired static intra-

abdominal pressure and gas flow rate.

Every user of the Gas Insufflator ML-G is self responsible to be familiar with the

devices operation and application as well as the procedure of endoscopic intra-

abdominal surgery. Only medically trained and according to MGB Endoskopische

Gerte GmbH Berlin training materials instructed professionals are allowed to use

the ML-G.

The Gas Insufflator ML-G must only be installed in medical facilities. The device is

intended to be used in earth-grounded medical locations meeting the usage

requirements for a type BF applied part.


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ML-GSafety

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3 Safety

Safety is everyones responsibility. The safe operation of this device is the

responsibility of the installer, user and maintainer. It is imperative to become familiar

with the entire manual before attempting to install, use, clean, service or adjust thisequipment. It is strongly recommended that the instructions in this manual are fully

understood and followed in order to ensure the safety of patients and users.

For this purpose, the following safety notes have been inserted at appropriate places

within this manual to highlight safety information or important instructions. All users

and maintainers must be familiar with and pay particular attention to all warnings,

notes and cautions in this manual.

WARNING

Warning indicates a hazard which, if not avoided, could lead to severe personalinjury, death or substantial damage to property.

NOTE

Note indicates information for the installation, operation or maintenance of thedevice which is so important that injury or damage could result if it is ignored.

CAUTION

Caution indicates a hazard which, if not avoided, could result in minor injury ordamage.

3.1 Safety SymbolsThe "International Electrotechnical Commission" (IEC) has established a set of

symbols for medical electronic equipment that classifies connections or warnings of

potential hazards. The classifications and symbols are shown below.


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ML-GSafety

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Article number

Lot number

SN Serial number

Connection for tube set for insufflation

Connection for tube set for irrigation

For disposable use only.

Iand Oon power switches stand for ON and OFF

respectively.

Type BF isolated patient connection.

Equipotential bonding interface.

This symbol identifies a safety notice. Ensure you understand

the function of this control before using it. The control function

is described in the appropriate user or service manual.

Location of manufacturer.

Identifies the point where the system protective earth conductor is

fastened to the chassis. A protective earth conductor is connected

to conductive parts of Class I equipment for safety purposes.


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ML-GSafety

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3.2 Environmental conditions

Avoid the following environmental conditions for operation or storage:

- Exposure to high humidity

- Exposure to water vapour

- Exposure to liquids

- Exposure to direct sunlight

- Exposure to dust or ashes

- Poorly ventilated environments

- Exposure to salty air

- Exposure to chemicals or gases

- Exposure to smoke

Avoid environments where the ambient temperature falls below 10C (50F) orexceeds 40C (104F) for normal operation, or falls below -10C or exceeds 70C

(14F-158F) for transportation and storage. Relative humidity should be maintained

between 30% and 75% for normal operation, regarding between 20% and 95% for

transportation and storage. Avoid environments where the equipment is exposed to

excessive shocks or vibrations.

3.3 Safety precautions

This insufflator has been developed and tested according to applicable safetystandards. This guarantees an extremely high level of safety for this device. We are

required by law to inform the user expressly regarding safety aspects when handling

the device. Correct handling of this equipment is imperative for its safe operation.

Please read all instructions carefully before switching on this device. For more

detailed information, please contact your local representative.

This equipmentmust not be used in areas with explosions hazard such as in

Oxygen enriched environments or in the vicinity of flammable, explosive or

volatile solvents such as alcohol, benzene or similar chemicals. Do not install or use this device in rooms with high humidity. Relative humidity

should be maintained between 30% and 75% for normal operation. Avoid

splashing the device with water or exposing it to dripping water or water spray.

Do not place containers with fluids or gases on top of electrical equipment of

any kind.

The equipment must only be used by or under direct supervision of an

appropriately trained and qualified person.

Modifications of this equipmentmay only be carried out by service technicians

or other authorized personnel of MGB Endoskopische Gerte GmbH Berlin.


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ML-GSafety

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Rev.2.0/06.12 7

Customer maintenance of this equipmentmay only be performed as stated in

the user manual. Additional maintenance work of any kind may only be

performed by service technicians or other authorized personnel of MGB

Endoskopische Gerte GmbH Berlin.

The manufacturer is only responsible for safety, reliability and performance ofthis equipment if the following requirements are fulfilled: (1) The electrical

installation in the respective room corresponds to the specifications stated in

this manual and (2) the equipment is used and maintained in accordance with

this manual.

The manufacturer is not liable for damage caused by unauthorized tampering

with the device(s). Such tampering will cause any rights to claim under warranty

to be forfeited.

This insufflator may only be used in combination with accessories supplied byMGB Endoskopische Gerte GmbH Berlin. If any other accessories are used,

the compatibility must be confirmed by MGB Endoskopische Gerte GmbH

Berlin.

Only persons who have read carefully and understood the instruction for use

may use this equipment. Installation and service of the device may not be

performed without proper training and instruction by service technicians or other

authorized personnel of MGB Endoskopische Gerte GmbH Berlin.

Keep the user manual in a place that is easily accessible at all times for persons

who use and service the equipment.

Do not use force when connecting cables. If a cable does not connect easily,

ensure that the connector (plug) is appropriate for the receptacle (socket). Any

damage caused to cable connectors or receptacles must only be repaired by a

service technician or other authorized personnel of MGB Endoskopische Gerte

GmbH Berlin.

Please never pull any cables. Always hold on to the plug when disconnecting

cables.

This equipment is to be used as specified in these operating instructions.

Before every operation, check the equipment visually for exterior mechanical

damage (and for proper function).

Do not cover any ventilation grids or slits.

Immediately switch off and disconnect any equipment that emits smoke, sparks,

strange noises or smells.


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MGBEquipotential bonding connections

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4 Equipotential bonding connections

CAUTION

EQUIPOTENTIAL BONDING

CONNECTIONS:

Doctors and patients may be

exposed to potentially

dangerous compensating

currents. These result from the

potential differences between

connected equipment and

exposed conducting parts. The

safest solution for this problem

is consistent equipotential

bonding using medical

equipment with an equipotential

terminal. This should at all times

be connected to the protective

earth with equipotential

converter for medical devices.

NOTE

This item conforms to the following standards and directives

- IEC60601-1 (EN60601-1, Safety of Medical Equipment)

* Class I, Type BF, protection against electric shock, equipment not suitable

for use in the presence of flammable anaesthetic mixtures

- IEC60601-1-2 (EN60601-1-2, Electromagnetic Compatibility Requirements)

* Class A for noise-emission, and Level B for noise-immunity.

Main Body

Equipotential

TerminalConnecting Lead

(Socket)

Equipotential

Connector

Protective Earth inMedical Room


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ML-GSafety

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NOTE

Auxiliary equipment connected to the device interface must be approved by

MGB Endoskopische Gerte GmbH Berlin. Those products are listed in current

version of product catalogue. If in doubt, please consult the customer service ofyour local MGB Endoskopische Gerte GmbH Berlin representative.

NOTE

The equipment and any additional devices must be disposed safely after the life

cycle of the equipment.

Old equipment and accessories can be disposed at MGB free of charge. For

more information consult the customer service of your local MGB

Endoskopische Gerte GmbH Berlin representative.


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ML-GFuse replacement

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5 Fuse replacement

Use only fuses with following specification: T 1.6 AL / 250 V.

Push the fuse holder Replace the old fuse

with a new one

1. The fuse holders are situated below the device power input.

2. Pull out the slender, protruding fuse holder as shown in the figure above.

3. Remove old fuses by pulling upwards.

4. Insert new fuses into the fuse holder.

5. Insert the fuse holder into the device power input and press it back into place.

WARNING

To ensure continued protection against fire hazard and personal injury, replace

with fuse of the same type and rating.


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ML-GCustomer service

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Rev.2.0/06.12 11

6 Customer service

If you have any problems with the equipment, please follow the steps below:

Note the model name, serial number, date of purchase and contact MGBEndoskopische Gerte GmbH Berlins local representative, giving a brief description

of the problem.

Writing down the model and serial numbers

The model number and the serial number are found on the reverse side of the

device. The serial number is unique to this unit. You should record the required

information here and retain this manual as a permanent record of your purchase.

Please retain your purchase receipt as proof of purchase.

Date of purchase

Local representatives name

Local representatives address

Local representatives phone no.

Model no.

Serial no.

For exceptional cases: contacting MGB Endoskopische Gerte GmbH Berlin

Write to us at:

MGB Endoskopische Gerte GmbH Berlin

Schwarzschildstrae 6

12489 Berlin

Germany

Tel: +49 (0) 3063 92 70 16

Fax: +49 (0) 3063 92 70 11

E-mail: [email protected]

Internet:www.mgb-berlin.de


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ML-GWarranty

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7 Warranty

MGB Endoskopische Gerte GmbH Berlin warrants to the first purchaser of this

equipment, for a period of two years from the date of sales, that this equipment,

when shipped in its original container, will be free from defective workmanship and

materials, and agrees that it will, at MGB Endoskopische Gerte GmbH Berlin s

option, either repair the defect, or replace the defective product or part thereof at no

charge to the purchaser for parts or labor.

Please notify MGB Endoskopische Gerte GmbH Berlins local representative if

problems arise.

This warranty is only valid if:

- The equipment is installed properly in appropriate environmental conditions as

specified in chapter 9, Installation.

- The equipment and associated accessories are used according to their

intended use following the specific instructions in the operating instructions for

the equipment being used.

- The equipment and associated accessories are maintained according to the

instructions in the operating instructions and service manual for the equipment

being used.

This warranty does not cover the following aspects:

- Damage and loss caused by acts of nature beyond control such as fire,flooding, storm, tidal waves, lightening and earthquake, or caused by theft,

abnormal operating conditions or unauthorized dismantling of the device.

- Accompanying or indirect damages resulting from the devices operation.

Refunds or replacements are not given for superficial defects. We dont accept

liability for damage or loss incurred after expiry of the warranty period.

In order to claim services covered under this warranty, customers must request the

service by notifying in writing the customer service at the local representative fromwhich the equipment was purchased.

The notification must specify the following:

- Product name

- Serial number

- Date of purchase

- Detaileddescription of the problem


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ML-GSafety

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MGB Endoskopische Gerte GmbH Berlin or its local representative will provide free

after-sales service for equipment and parts covered under the warranty during the

warranty period. Written notification may be forwarded by letter, fax, or e-mail;

however, the notification is not regarded as official until it has been received at the

customer service of the local representative or of MGB Endoskopische Gerte GmbHBerlin headquarters.

If the equipment has to be shipped back to the local representative or to MGB

Endoskopische Gerte GmbH Berlin, the customer must pack the defective

equipment in an appropriate return box.

This warranty replaces all other warranties, including any compatibility or product

warranty/ies for specific areas which may be concerned. Improper use or incorrect

handling of the equipment relieves MGB Endoskopische Gerte GmbH Berlin and

MGB Endoskopische Gerte GmbH Berlins local representatives of liability for the

devices non-compliance with specifications and of liability for any damage or injury

incurred.

The equipment must only be used by or under direct supervision of a properly trained

and qualified person. The manufacturer is not liable for damage caused by

unauthorized tampering, use, installation, and maintenance of the equipment and

associated accessories. Such unauthorized activity/ies shall cause any rights to claim

under warranty to be forfeited.


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ML-GTechnical Specification

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14 Rev.2.0/06.12

8 Technical Specification

Power supply & frequency 100-240 VAC, 50/60 Hz

Power consumption 45 VA (max.)

Safety class I, type BF

Protection IP X0

Dimensions [W x D x H] 380 x 341 x 180 mm

Weight 17.5 kg

Operating temperature +10C - +40C

Storage/Transportationtemperature -10C - +70C

Operating relative humidity 30% - 75%

Storage/Transportation relative

humidity 20% - 95%

Insufflation gas Medical grade CO2

Operating pressure 0 - 30 mmHg

Gas flow 0 - 40 l/min,

CO2 connection DIN EN ISO 11117 Standard

CO2 bottle input pressure 25 bar (min.) - 100 bar (max.)

Centralized CO2 gas supply input

pressure 0.75 bar (min.) - 5 bar (max.)


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ML-GInstallation

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9 Installation

Installation and service of the device may not be performed without proper training

and instruction by service technicians or other authorized personnel of MGB

Endoskopische Gerte GmbH Berlin!

9.1 Inspection upon delivery

Carefully unpack the unit upon delivery and ensure that all items listed below are

included in the box. Save all packaging materials which may be needed to

substantiate any claims for damages caused by the shipper.

ML-G console

Silicon tube to patient (3 m)

Silicon tube to irrigation bottle (1 m)

Silicon tube to irrigation cannula (3 m)

Power cable

User manual

9.2 System displays

9.2.1 General

CO2 gas bottle

CO2reserve manometer: The gas reserve in the CO2tank is displayed

CO2gas tube

Main power switch. I = ON, O = OFF

Silicon tubes for insufflation and irrigation

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ML-GInstallation

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9.2.2 Rear panel connections

1. Speaker grid

2. Equipotential bonding terminal

3. Gas input connector German DIN standard

4. Power input

5. Fuse holder

1 2 3 4 5

9.2.3 Front panel

The ML-G front panel is divided into different sections for:

1. Pressure selection

2. Measurement of CO2bottle pressure

3. Indicator for abdominal pressure4. Excess pressure warning indicator

5. Indicator for insufflation flow rate

6. Indicator for total gas consumption

7. Gas flow selection / monitoring

8. Gas insufflation start/stop button

9. Connection to irrigation

10. Connection to CO2-Filter-Kit

1 2 3 4 5 6 7 8 9 10


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MGBInstallation

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9.2.4 Warning signals section

Measurement of CO2bottle pressure

When a CO2bottle is connected to the insufflator with the supply open,

and the device must be set to bottle gas supply (see 9.5), the insufflator

constantly checks whether thepressure of the CO2bottle is safe for

use. The number of illuminated indicator fields is proportional to the gas

pressure of the bottle. If the pressure of the CO2bottle is inappropriate

for use, the bottom red LED lights up and warning signals are sounded.

9.2.5 Pressure monitoring section

Indicator for abdominal pressure measured in mmHg

The insufflator constantly monitors the abdominal pressure.

The pressure is shown on the display. The unit is mmHg.

Excess abdominal pressure warning indicator

The insufflator constantly checks the abdominal pressure while

usage. When the abdominal pressure rises more than 3 mmHg

above the pre-set pressure, the warning indicator lights up.

Pressure selection

The pressure is normally set at 12 mmHg. To set the abdominal

pressure, press the respective button for raising or lowering it.

The pressure can thus be set to values between 1 and 30

mmHg.

9.2.6 Indicator for insufflation flow rate measured in l/min

Volume control button for voice direction system.

Button for adjusting the volume of the voice directions - alternates from

high medium low off high

The current gas flow rate is measured and displayed after a

delay of 1 second. The unit is l/min.


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ML-GInstallation

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Gas flow selection

The insufflator provides different gas flow rates which can beselected. Selecting the desired gas flow rate:

- Low flow rate: approx. 1-2 l/min for initial gas injection

- Medium flow rate: approx. 7-8 l/min- High flow rate: approx. 35-40 l/min for special use i.e. suctionof air for clarity

- Auto flow: Initially 1-2 l/min for initial gas injection,automatically detects high-flow condition

9.2.7 Insufflation monitoring and connection section

Indicator for total gas consumption

The insufflator provides an indicator for total gas consumption inlitres. The RESET button resets the digital gas consumptionmeter to zero.

Irrigation start/stop key and tube port

Key to start or stop the irrigation. The key is lit when ML-G

Irrigator operates, and blows out when the key is pressed oncemore to stop irrigation. Tube port is fitting to standard medicalluer lock according to DIN EN 1707.

Gas insufflation start/stop button and connection to CO2-Filter-Kit

This is the button for starting and stopping insufflation.The button lights up during insufflation, and the lightgoes out when the button is pressed once more to stopinsufflation. The connection to CO2-Filter-Kit is

compatible with the CO2-Filter-Kit provided by MGBEndoskopische Gerte GmbH Berlin.

9.3 Installation of power supply

The power supply cable must be checked for suitability for the device before

turning power ON (100- 240 VAC / 50-60 Hz.) After checking the power supply

cable, it may be plugged into a suitable socket with protective earth. The other

end of the power supply cable fits into the power input on the reverse side of the

device.

The device should be connected to an existingequipotential bonding terminal andmust be completely grounded.


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MGBInstallation

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NOTE

Equipotential bonding

Doctors and patients may be exposed to dangerous, compensating currents.

The solution for these problems is consistent equipotential bonding. For further

details please refer to Equipotential bonding in Section 4.

NOTE

As far as possible, avoid placing the device near power generators, X-ray

devices, broadcasting stations and transmission lines to avoid electrical noise

during use.

9.4 Installation of CO2 bottle

Connect a gas hose to the rear gas connection or establish a connection with the

central gas supply. Make sure that only medically clean CO2is used.

To connect the gas bottle, screw the nut on the device onto the thread for gas

connections on the CO2bottle.

For pin index connection, place the CO2 bottle and the pin index high pressure

hose into the correct position. Fixate the hose to the bottle by tightening the hand

wheel of pin index connector.

We recommend closing the valve of the CO2 gas bottle after use, as gas can

escape through the valve over night.

9.5 Special installation

Choosing the type of gas supply

There are basically two

types of gas supply: CO2

bottle gas supply and

centralised gas supply.

The main reason for

having these two modes

is the different input

pressure. For centralised

gas supply, the input

pressure can be adjusted

up to 10 bar in most European hospitals.To ensure compatibility with the different

types of gas supply, the insufflator can be set accordingly. Press all three buttons asindicated above to activate the desired type of gas supply.

Centralized gassupply

Bottle gas

supply


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ML-GInstallation

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NOTE

The type of gas supply should be selected permanently when first installing theinsufflator.

NOTE

The factory setting is bottle mode.

NOTE

If the gas bottle pressure drops below the operational pressure but there is a

requirement to use the insufflator regardless of gas bottle pressure (e. g.

exhibition or demonstration), or if there is an extra gas tank available during

operation, you can switch the mode to centralised gas supply. Please readjustthe mode to bottle gas supply though once this requirement has expired.

9.6 Calibration of pressure sensors zero value

The calibration of pressure sensors zero value is required after

transportation, installation and after any service procedure. The

calibration procedure adjusts the zero value according to locals

atmospheric pressure.

For calibration, please press the VOLUME as well as the UPand DOWN buttons of pressure setting simultaneously and turnon the device. A beep sound confirms the successfullycompleted calibration.

WARNING

Never do calibration during usage of insufflator on patient!

For proper calibration the insufflator has to be in standby mode, which means

that the device is switched on but does not have connection to the patient

through insufflation tube and no insufflation mode is activated.

9.7 Function test after installation

After proper installation, check function as specified in the check list in chapter 11.2.


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ML-GOperation

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10 Operation

During operation, the insufflator controls the gas flow in accordance with the pre-

selected static abdominal pressure at an optimized, physiologically tolerable rate.

Insufflation is safely controlled by two user settings only: the desired static abdominalpressure and the flow rate.

10.1 Preparing the device for operation

1. Before turning on the device, check to make sure that the AC power is correctly

plugged in. Then, turn on the device using the switch on the left of the front panel.

2. The valve of the CO2gas bottle must be opened before start of the examination.

Check that at least three of the four indicator fields for CO2bottle pressure are lit

up. Please note that if the gas pressure is inappropriate for use (below 25 bar) the

remaining indicator flashes, a warning signal is sounded, and insufflation is not

possible.

3. Connect the CO2-Filter-Kit.

4. Before each use, flush the system with a minimum of 0.5 litres of CO2with the

CO2-Filter-Kit connected, in order to expel non-sterile gas from the device and the

CO2-Filter-Kit. Press the start/stop button to start and wait until the gas

consumption indicator shows 0.5, then press the start/stop button again to stop

the insufflation. To obtain a correct indication of the gas consumption during theexamination, press the RESET key below the gas consumption display. The gas

consumption display will be reset to 0.0.

10.2 Operating Steps

1. Set the required abdominal pressure using the buttons shown in Section 9.2.3 No.

1. It can be adjusted between 0 and 30 mmHg (default pressure is 12 mmHg).

2. Select the required insufflation rate. The corresponding button will indicate the

active insufflation rate. Default value for insufflation rate is low, (1.0 l/min) if the

last user selected the flow rate in manual mode, and automatic flow if the last user

selected automatic flow. Start insufflation by pressing the start/stop button shown

in Section 9.2.3 No. 8. The current pressure display shows the measured value of

the abdominal pressure. As soon as this value exceeds the selected abdominal

pressure value, minimum gas flow is activated. The flow rate indicator displays

the flow rate of the last flow period. The gas consumption display indicates the

current volume of gas that has been consumed.

3. If needed the gas flow rate and maximum abdominal pressure may be adjusted at

any time during the examination without interrupting the insufflation process.


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ML-GMaintenance

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4. If during insufflation a higher abdominal pressure is measured than the value

selected, the device will interrupt the insufflation until the abdominal pressure is

less than 3 mmHg above the selected value. A pulsating continuous signal will be

heard for two seconds, after which the insufflator releases the gas to bring the

pressure down to the preset abdominal pressure in case the pressure is still too

high.

5. Stop insufflation by pressing the start/stop button. The indicator for insufflation will

be turned off.

6. Shut off the gas supply and turn off the main switch.

CAUTION

Electronical control of the device: with the patient tube connected, an intra

operational closing of the valve at the trocar cannula is not necessary. The

electronical control will maintain the required intra-abdominal pressure.

1. Filled CO2bottle for replacement

Always have a filled CO2 bottle ready for replacement. This will prevent an

interruption of the operation due to insufficient gas for insufflation.

2. Rapid lowering of colon pressure

When the abdomen is filled with CO2, a reduction of the pre-selected abdominal

pressure will not result in a decrease of the actual abdominal pressure. To lower

the abdominal pressure rapidly, create a leakage by disconnecting the CO2-Filter-Kit from the CO2-Filter-Kit connection.

3. High gas flow

If for no apparent reason there is a high gas flow during treatment, immediately

check the system for leakage.

4. Deficiency of the device

If any deficiency is suspected or confirmed in the device, do not use the device

until it has been checked by the authorized service.

5. Control of the body temperature

In case of unfavorable operating conditions (high leakage rate, high volumeof insufflation, long operation time), make sure that the patient does not

suffer uncontrolled hypothermia, since the insufflation draws heat from the

body. The body temperature must be controlled under such operation

conditions.

6. Fatigue symptoms

When there is a high level of CO2 consumption make sure to supply the

operating area with enough fresh air, since an increasing CO2 level of the air

can result in fatigue symptoms of the medical personnel.


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NOTE

Be sure to observe applicable hygiene regulations when disposing of the CO2-

Filter-Kit. Please use disposable CO2-Filter-Kits approved by MGB

Endoskopische Gerte GmbH Berlin only.

Programming overview

The following flow chart is helpful for understanding the workflow of this device. Please

study the flow chart carefully.

Start of Insufflation

Monitoring

of colon

pressure

Initial

insufflation?

Start insufflation with

1st circle: low flow

2 nd circle: medium flow

3 rd circle: high flow

Automatic

flow?

Yes

Yes

Operational colon

pressure reached,

low flow rate enabled

No

Monitoring

of colon

pressure

No

Excessive

Pressure ?

Alarm and pres-

sure monitoring

for two seconds

Excessive

pressure

problem

solved ?

Yes

Yes

Release gas to reach

pre-set pressure

No

Determine the flow

rate

1/ 2/ 4 l/min

No

Open outlet

to insufflate

for1 sec if there is

more than 1 l/min

flow rate

Excessive

pressured by

insufflation?

Yes

No

10.3 Procedure after use

1. Switch off the device.

2. Disconnect and discard CO2-Filter-Kit.3. Close the valve on the gas bottle tightly.

NOTE

Monitoring of

abdominal pressureMonitoring of

abdominal pressure

Operational abdominal

pressure reached, low

flow rate enabled


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ML-GMaintenance

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24 Rev.2.0/06.12

11 Maintenance

11.1 Cleaning

For cleaning, turn off the device (main switch) and remove the power cable.

For exterior cleaning of the device, use a hydrous disinfecting solution or Ethanol

(100%). To keep the device clean, rub it gently with a soft, damp cloth (gauze)

moistened with warm water or detergent at least once a month. Liquid must never

be allowed to enter the interior of the device.

Do not use lacquer thinner, acetone or any other organic solvents, as these can

destroy the casing of the device.

Cleaning and disinfecting with inflammable or explosive liquids should be

avoided. If this is inevitable, these liquids must be allowed to completely

evaporate before the device is switched on. Do not use ethylene oxide fordisinfection!

There are different ways of cleaning the casing of the insufflator. Please first

decide whether it is to be cleaned or disinfected. Disinfection can be performed

using a liquid disinfectant.

Accessories (tube set, verres needle) have to be taken apart, cleaned,

disinfected and sterilized after each usage. Use steam sterilization with 134C, 3

bar for 5 minutes. Please note that only clean and disinfected surfaces can be

sterilized effectively.

Please take apart the verres needle carefully into the cannula and the stylet. Inorder to clean the lumens open the cock of the cannula and use running

demineralized water. After that use a cleaning pistol. Pay attention during

cleaning process that the cock of the verres needle is opened! Air-clean the

lumens of the verres needle. Finally check for any residues by visual inspection

and repeat the process if necessary.

The silicone tubes have to be rinsed under running tap water first and then again

with demineralized water. Please let the components drip off thoroughly and wipe

them dry with some soft tissue afterwards. Disinfect the tubes afterwards.

Please check all components for mechanical damaging after each cleaning

process.

Warning

Damaged components may not be used anymore!


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Rev.2.0/06.12 25

The following table shows by MGB recommended accessories for insufflation and

irrigation and the proper methods for reprocessing.

Order-No. Description Cleaning Sterilization

670-95300 Silicone tube set forinsufflation, 1x3m/1x0,1m

In tube cleaningmachine

Steam sterilization;

134C, 3 bar, 5 min

670-95301Silicone tube set for irrigation,

1x3m/ 1x1m

In tube cleaning

machine


134C, 3 bar, 5 min

670-95312Tube connection (LUER-

Lock), maleManual


134C, 3 bar, 5 min

670-95350Veress needle, 2 mm,

length 150 mm, stainless steelManual


134C, 3 bar, 5 min


length 100 mm, stainless steelManual


134C, 3 bar, 5 min


length 120 mm, EdelstahlManual


134C, 3 bar, 5 min

675-11202 Adaptor for insufflation ManualSteam sterilization;

134C, 3 bar, 5 min

11.2 Functional Check List before each insufflation

After connecting the CO2gas bottle:

Check whether gas leaks from connection.

Check whether the device is correctly connected.

Check whether gas flow starts/stops upon pressing gas start/stop button.

Check high pressure alarm function: start insufflations and close the connector to

CO2-Filter-Kit by hand. After the preset pressure has been reached, the

insufflators must follow the process described in section 10.2.4.

Check reset function: by pressing reset button the value should change to 0.


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26 Rev.2.0/06.12

11.3 Troubleshooting

In case of problems with this device, first check the following list before you call

your local MGB Endoskopische Gerte GmbH Berlin representative. Should the

difficulty persist, turn OFF and UNPLUG the unit. Then contact your service

technician or local authorized MGB Endoskopische Gerte GmbH Berlin service

facility.

Performance problems can often be easily solved by checking for seemingly

obvious but frequently overlooked causes. If a problem occurs, check if it can be

remedied by any of the corrective actions described below before sending the unit

in for servicing. Simple checks carried out beforehand can save time and money.

Symptoms Corrective actions

None of the LEDs on the frontpanel light up when the device isswitched on

Check if the mains plug is connected tothe socket and the device input.

Check the mains fuses on the rear panelof the device. If they are interruptedcontact your local MGB EndoskopischeGerte GmbH Berlin representative.

No gas flow

Check the pressure of the gas bottle (if

used) as well as the connection betweenthe CO2source and the device. If they arewell connected and the problem remains,contact the customer service of your localrepresentative.

11.4 Maintenance

Regular maintenance helps to discover possible problems at an early stage and

therefore improves safety and lifetime of this device.

The safety-related check is to be performed yearly. This has to be done by

specialized personnel and according to the service manual.


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ML-GNotes

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27 Rev.2.0/06.12


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MGB Endoskopische Gerte GmbH Berlin

Customer Service

Schwarzschildstrae 6

12489 Berlin

GermanyPhone: +49-30-6392-7016

Fax: +49-30-6392-7011

E-Mail: [email protected]

Website: www.mgb-berlin.de

RoHS/WEEE Environmental Legislation

(only for selling in EU)

RoHS Compliance regarding Directive 2002/95/EC

registered by EAR/Germany :

WEEE DE 68052334

ML-G User Manual English

Documents

Transcript of ML-G User Manual English