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Operating Instructions

Gas Insufflator ML-G

Operating Instructions Gas Insufflator ML-G Copyright 2012 MGB Endoskopische Geräte GmbH Berlin Rev.2.0 / 06.12 MGB

Copyright 2012 MGB Endoskopische Geräte GmbH Berlin Rev.2.0 / 06.12

Operating Instructions Gas Insufflator ML-G Copyright 2012 MGB Endoskopische Geräte GmbH Berlin Rev.2.0 / 06.12 MGB

ML-G Table of contents

ML-G – Table of contents

Copyright Details

Copyright 2010 by MGB Endoskopische Geräte 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 Geräte GmbH Berlin (printed in Germany).

Table of Contents

Introduction

  • 1 ...................................................................................................................

2

Intended Use

  • 2 ..................................................................................................................

3

Safety

  • 3 .............................................................................................................................

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

Warranty

  • 7 .......................................................................................................................

12

  • 8 Technical Specification

14

Installation

  • 9 ...................................................................................................................

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

CO 2 bottle

19

9.5

Special installation

19

9.6

Calibration of pressure sensor’s zero value

20

9.7

Function test after installation

20

  • 10 Operation

21

  • 10.1 the device for operation

Preparing

21

 
  • 10.2 Steps

Operating

21

  • 10.3 Procedure after use

23

 
  • 11 Maintenance

24

  • 11.1 Cleaning....................................................................................................................

24

 
  • 11.2 Functional Check List before each insufflation

25

Troubleshooting

  • 11.3 ........................................................................................................

26

Maintenance

  • 11.4 .............................................................................................................

26

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ML-G Introduction

1

Introduction

Thank you for purchasing the MGB Endoskopische Geräte GmbH Berlin ML-G for endoscopic procedures. This device has been scientifically designed and manufactured to meet the highest standards required internationally for applications relating to CO 2 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 staff who 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-G Intended use

ML-G – Intended use
  • 2 Intended Use

The Gas Insufflator ML-G (Article-No. 670-95600) is designed for insufflation of medical grade CO 2 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

device’s operation and application as well as the procedure of endoscopic intra-

abdominal surgery. Only medically trained and according to MGB Endoskopische Geräte 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-G Safety

3

Safety

Safety is everyone’s 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 this equipment. 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 personal injury, death or substantial damage to property.

NOTE

“Note” indicates information for the installation, operation or maintenance of the

device 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 or damage.

  • 3.1 Safety Symbols

The "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-G Safety

ML-G – Safety
  • Article number

  • Lot number

SN

Serial number

  • Connection for tube set for insufflation

ML-G – Safety Article number Lot number SN Serial number Connection for tube set for insufflation

Connection for tube set for irrigation

  • For disposable use only.

ML-G – Safety Article number Lot number SN Serial number Connection for tube set for insufflation

Iand Oon power switches stand for ON and OFF respectively.

  • Type BF isolated patient connection.

Equipotential bonding interface.

Equipotential bonding interface.

This symbol identifies a safety notice. Ensure you understand the function of this control before using

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.

Location of manufacturer.

ML-G – Safety Article number Lot number SN Serial number Connection for tube set for insufflation

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-G Safety

  • 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 10°C (50°F) or exceeds 40°C (104°F) for normal operation, or falls below -10°C or exceeds 70°C (14°F-158°F) 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 safety standards. 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 equipment must 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 equipment may only be carried out by service technicians or other authorized personnel of MGB Endoskopische Geräte GmbH Berlin.

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ML-G Safety

ML-G – Safety
  • Customer maintenance of this equipment may 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 Geräte GmbH Berlin.

  • The manufacturer is only responsible for safety, reliability and performance of this 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 by MGB Endoskopische Geräte GmbH Berlin. If any other accessories are used, the compatibility must be confirmed by MGB Endoskopische Geräte 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 Geräte 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 Geräte 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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MGB Equipotential bonding connections

  • 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.

 
Connector Main Body Equipotential Terminal Connecting Lead (Socket) Equipotential Protective Earth in Medical Room
Connector
Main Body
Equipotential
Terminal
Connecting Lead
(Socket)
Equipotential
Protective Earth in
Medical Room

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.

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ML-G Safety

ML-G – Safety

NOTE

Auxiliary equipment connected to the device interface must be approved by MGB Endoskopische Geräte GmbH Berlin. Those products are listed in current version of product catalogue. If in doubt, please consult the customer service of your local MGB Endoskopische Geräte 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 Geräte GmbH Berlin representative.

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ML-G Fuse replacement

  • 5 Fuse replacement

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

ML-G – Fuse replacement 5 Fuse replacement Use only fuses with following specification: T 1.6

Push the fuse holder

ML-G – Fuse replacement 5 Fuse replacement Use only fuses with following specification: T 1.6

Replace the old fuse with a new one

ML-G – Fuse replacement 5 Fuse replacement Use only fuses with following specification: T 1.6
  • 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-G Customer service

ML-G – Customer service
  • 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 MGB Endoskopische Geräte GmbH Berlin‘s 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 representative’s name

 

Local representatives address

 

Local representative’s phone no.

 

Model no.

 

Serial no.

 

For exceptional cases: contacting MGB Endoskopische Geräte GmbH Berlin

Write to us at:

MGB Endoskopische Geräte GmbH Berlin

Schwarzschildstraße 6

Tel:

Fax:

E-mail:

+49 (0) 30 63 92 70 16 +49 (0) 30 63 92 70 11 service@mgb-berlin.de

12489 Berlin Germany

Internet: www.mgb-berlin.de

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ML-G Warranty

7

Warranty

MGB Endoskopische Geräte 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 Geräte 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 Geräte GmbH Berlin’s 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 device’s operation.

Refunds or replacements are not given for superficial defects. We don’t 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 from which the equipment was purchased.

The notification must specify the following:

  • - Product name

  • - Serial number

  • - Date of purchase

  • - Detailed description of the problem

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ML-G Safety

ML-G – Safety

MGB Endoskopische Geräte 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 Geräte GmbH Berlin headquarters.

If the equipment has to be shipped back to the local representative or to MGB Endoskopische Geräte 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 Geräte GmbH Berlin and MGB Endoskopische Geräte GmbH Berlin’s local representatives of liability for the device’s 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-G Technical Specification

  • 8 Technical Specification

Power supply & frequency

100-240 VAC, 50/60 Hz

Power consumption

 

45

VA (max.)

   

I, type BF

Safety class Protection

 

IP X0

Dimensions [W x D x H]

380 x 341 x 180 mm

Weight

 

17.5

kg

 

+10°C - +40°C

Operating temperature Storage/Transportation temperature

-10°C - +70°C

 

30% - 75%

Operating relative humidity Storage/Transportation relative humidity

20% - 95%

Insufflation gas

Medical grade CO 2

 

0

- 30 mmHg

Operating pressure Gas flow

0

- 40 l/min,

CO 2 connection

DIN EN ISO 11117 Standard

   

25

bar (min.) - 100 bar (max.)

CO 2 bottle input pressure Centralized CO 2 gas supply input pressure

 

0.75

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

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ML-G Installation

ML-G – Installation

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 Geräte 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

CO 2 gas bottle

CO 2 reserve manometer: The gas reserve in the CO 2 tank is displayed

CO 2 gas tube

Main power switch. I = ON, O = OFF

Silicon tubes for insufflation and irrigation

1 2 3 4 5
1
2
3
4
5

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ML-G Installation

  • 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
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 CO 2 bottle pressure
3.
Indicator for abdominal pressure
4.
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 CO 2 -Filter-Kit
1
2
3 4
5
6
7
8
9
10

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MGB Installation

MGB – Installation
  • 9.2.4 Warning signals section

Measurement of CO 2 bottle pressure

MGB – Installation 9.2.4 Warning signals section Measurement of CO bottle pressure Volume control button for

Volume control button for voice direction system.

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

high → medium → low → off → high → …

MGB – Installation 9.2.4 Warning signals section Measurement of CO bottle pressure Volume control button for

When a CO 2 bottle 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 the pressure of the CO 2 bottle is safe for use. The number of illuminated indicator fields is proportional to the gas pressure of the bottle. If the pressure of the CO 2 bottle 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

MGB – Installation 9.2.4 Warning signals section Measurement of CO bottle pressure Volume control button for

The insufflator constantly monitors the abdominal pressure. The pressure is shown on the display. The unit is mmHg.

Excess abdominal pressure warning indicator

MGB – Installation 9.2.4 Warning signals section Measurement of CO bottle pressure Volume control button for

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

MGB – Installation 9.2.4 Warning signals section Measurement of CO bottle pressure Volume control button for

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

MGB – Installation 9.2.4 Warning signals section Measurement of CO bottle pressure Volume control button for

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-G Installation

Gas flow selection

ML-G – Installation Gas flow selection The insufflator provides different gas flow rates which can
ML-G – Installation Gas flow selection The insufflator provides different gas flow rates which can

The insufflator provides different gas flow rates which can be selected. 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. suction of 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

ML-G – Installation Gas flow selection The insufflator provides different gas flow rates which can

The insufflator provides an indicator for total gas consumption in litres. The RESET button resets the digital gas consumption meter to zero.

Irrigation start/stop key and tube port

ML-G – Installation Gas flow selection The insufflator provides different gas flow rates which can
ML-G – Installation Gas flow selection The insufflator provides different gas flow rates which can

Key to start or stop the irrigation. The key is lit when ML-G Irrigator operates, and blows out when the key is pressed once more to stop irrigation. Tube port is fitting to standard medical

luer lock according to DIN EN 1707.

Gas insufflation start/stop button and connection to CO 2 -Filter-Kit

This is the button for starting and stopping insufflation.

ML-G – Installation Gas flow selection The insufflator provides different gas flow rates which can

The button lights up during insufflation, and the light goes out when the button is pressed once more to stop insufflation. The connection to CO 2 -Filter-Kit is compatible with the CO 2 -Filter-Kit provided by MGB

Endoskopische Geräte 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 existing equipotential bonding terminal and must be completely grounded.

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MGB Installation

MGB – Installation

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 CO 2 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 CO 2 is used.

    • To connect the gas bottle, screw the nut on the device onto the thread for gas connections on the CO 2 bottle.

    • For pin index connection, place the CO 2 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 CO 2 gas bottle after use, as gas can escape through the valve over night.

      • 9.5 Special installation

Choosing the type of gas supply

 
“ Centralized gas sup ply” “Bottle gas s upply”
“ Centralized gas sup ply” “Bottle gas s upply”
 
“ Centralized gas sup ply”

Centralized gas supply”

“Bottle gas
“Bottle gas
“Bottle gas

“Bottle gas

supply”

There are basically two

types of gas supply: CO 2 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 as indicated above to activate the desired type of gas supply.

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ML-G Installation

NOTE

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

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 readjust the mode to ‘bottle gas supply’ though once this requirement has expired.

  • 9.6 Calibration of pressure sensor’s zero value

ML-G – Installation NOTE The type of gas supply should be selected permanently when first

The calibration of pressure sensor’s zero value is required after

transportation, installation and after any service procedure. The

calibration procedure adjusts the zero value according to local’s

atmospheric pressure.

For calibration, please press the VOLUME as well as the UP and DOWN buttons of pressure setting simultaneously and turn on the device. A beep sound confirms the successfully completed 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-G Operation

ML-G – Operation

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 abdominal pressure 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 CO 2 gas bottle must be opened before start of the examination. Check that at least three of the four indicator fields for CO 2 bottle 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 CO 2 -Filter-Kit.

    • 4. Before each use, flush the system with a minimum of 0.5 litres of CO 2 with the CO 2 -Filter-Kit connected, in order to expel non-sterile gas from the device and the CO 2 -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 the examination, 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-G Maintenance

  • 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 CO 2 bottle for replacement

Always have a filled CO 2 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 CO 2 , 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 CO 2 - Filter-Kit from the CO 2 -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 volume of 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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ML-G Operation

ML-G – Operation

NOTE

Be sure to observe applicable hygiene regulations when disposing of the CO 2 - Filter-Kit. Please use disposable CO 2 -Filter-Kits approved by MGB Endoskopische Geräte GmbH Berlin only.

NOTE
NOTE

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

Yes Yes Release gas to reach pre-set pressure No Determine the flow rate 1/ 2/ 4
Yes
Yes
Release gas to reach
pre-set pressure
No
Determine the flow
rate
1/ 2/ 4 l/min
No
Excessive
solved ?
pressure
of colon
Monitoring
abdominal pressure
Monitoring of
flow?
Automatic
Operational colon
No
more than 1 l/min
flow rate
Excessive
pressured by
insufflation?
Yes
Open outlet
flow rate enabled
pressure reached,
for1 sec if there is
Excessive
Pressure ?
Alarm and pres-
sure monitoring
for two seconds
to insufflate
pressure
problem

Programming overview

No abdominal pressure Monitoring of Initial Yes rd circle: high flow 3 nd circle: medium flow
No
abdominal pressure
Monitoring of
Initial
Yes
rd circle: high flow
3
nd circle: medium flow
2
low flow
1st circle:
Start insufflation with
insufflation?
pressure
of colon
Monitoring

Start of Insufflation

Yes

No

Operational abdominal low flow rate enabled pressure reached, low
Operational abdominal
low flow rate enabled
pressure reached, low
  • 10.3 Procedure after use

    • 1. Switch off the device.

    • 2. Disconnect and discard CO 2 -Filter-Kit.

    • 3. Close the valve on the gas bottle tightly.

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ML-G Maintenance

11

11.1

Maintenance

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

for

disinfection!

  • 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 134°C, 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. In order 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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ML-G Maintenance

ML-G – Maintenance

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 for insufflation, 1x3m/1x0,1m

In tube cleaning machine

Steam sterilization; 134°C, 3 bar, 5 min

670-95301

Silicone tube set for irrigation, 1x3m/ 1x1m

In tube cleaning machine

Steam sterilization; 134°C, 3 bar, 5 min

670-95312

Tube connection (LUER- Lock), male

Manual

Steam sterilization; 134°C, 3 bar, 5 min

670-95350

Veress needle, Ø 2 mm, length 150 mm, stainless steel

Manual

Steam sterilization; 134°C, 3 bar, 5 min

670-95351

Veress needle, Ø 2 mm, length 100 mm, stainless steel

Manual

Steam sterilization; 134°C, 3 bar, 5 min

670-95352

Veress needle, Ø 2 mm, length 120 mm, Edelstahl

Manual

Steam sterilization; 134°C, 3 bar, 5 min

675-11202

Adaptor for insufflation

Manual

Steam sterilization; 134°C, 3 bar, 5 min

  • 11.2 Functional Check List before each insufflation

After connecting the CO 2 gas 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 CO 2 -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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ML-G Maintenance

  • 11.3 Troubleshooting

    • In case of problems with this device, first check the following list before you call your local MGB Endoskopische Geräte GmbH Berlin representative. Should the difficulty persist, turn OFF and UNPLUG the unit. Then contact your service technician or local authorized MGB Endoskopische Geräte 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 LED’s on the front

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

panel light up when the device is switched on

  • Check the mains fuses on the rear panel of the device. If they are interrupted contact your local MGB Endoskopische Geräte GmbH Berlin representative.

No gas flow

  • Check the pressure of the gas bottle (if used) as well as the connection between the CO 2 source and the device. If they are well connected and the problem remains, contact the customer service of your local representative.

  • 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-G Notes

ML-G – Notes

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ML-G Notes

_____________________________________________________________________________________________________

ML-G Maintenance

ML-G – Maintenance

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MGB Endoskopische Geräte GmbH Berlin

Customer Service Schwarzschildstraße 6 12489 Berlin Germany

Phone:

+49-30-6392-7016

Fax:

+49-30-6392-7011

E-Mail:

service@mgb-berlin.de

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

MGB Endoskopische Geräte GmbH Berlin Customer Service Schwarzschildstraße 6 12489 Berlin Germany Phone: +49-30-6392-7016 Fax: +49-30-6392-7011