MGB Endoskopische Gerte GmbH Berlin * Schwarzschildstr.

6 * 12489 Berlin * Germany

Telephone 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

ML-G Table 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 CO
2
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 .......................................................... 25
11.3 Troubleshooting ........................................................................................................ 26
11.4 Maintenance ............................................................................................................. 26
ML-G Introduction
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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 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.

ML-G Intended 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 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
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.


ML-G Safety
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4 Rev.2.0/06.12
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 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.
ML-G Safety
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Rev.2.0/06.12 5


Article number

Lot number
SN
Serial number

Connection for tube set for insufflation

Connection for tube set for irrigation

For disposable use only.

I and O on 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.

ML-G Safety
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6 Rev.2.0/06.12
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) or
exceeds 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 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 Gerte GmbH Berlin.
ML-G Safety
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Rev.2.0/06.12 7
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 Gerte 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 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.
MGB Equipotential bonding connections
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8 Rev.2.0/06.12
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
Terminal
Connecting Lead
(Socket)
Equipotential
Connector
Protective Earth in
Medical Room
ML-G Safety
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Rev.2.0/06.12 9
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 of
your 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.


ML-G Fuse replacement
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10 Rev.2.0/06.12
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.



ML-G Customer 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 MGB
Endoskopische 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) 30 63 92 70 16
Fax: +49 (0) 30 63 92 70 11
E-mail: service@mgb-berlin.de
Internet: www.mgb-berlin.de


ML-G Warranty
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12 Rev.2.0/06.12
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 Berlins
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 from
which the equipment was purchased.

The notification must specify the following:

- Product name
- Serial number
- Date of purchase
- Detailed description of the problem

ML-G Safety
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Rev.2.0/06.12 13
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 GmbH
Berlin 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.
ML-G Technical 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/Transportation
temperature -10C - +70C
Operating relative humidity 30% - 75%
Storage/Transportation relative
humidity 20% - 95%
Insufflation gas Medical grade CO
2

Operating pressure 0 - 30 mmHg
Gas flow 0 - 40 l/min,
CO
2
connection DIN EN ISO 11117 Standard
CO
2
bottle input pressure 25 bar (min.) - 100 bar (max.)
Centralized CO
2
gas supply input
pressure 0.75 bar (min.) - 5 bar (max.)


ML-G Installation
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Rev.2.0/06.12 15
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
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


ML-G Installation
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16 Rev.2.0/06.12
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 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

MGB Installation
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Rev.2.0/06.12 17
9.2.4 Warning signals section
Measurement of CO
2
bottle pressure


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

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.
ML-G Installation
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18 Rev.2.0/06.12
Gas flow selection



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

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


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.
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 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 existing equipotential bonding terminal and
must be completely grounded.
MGB Installation
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Rev.2.0/06.12 19

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
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.



Centralized gas
supply


Bottle gas
supply
ML-G Installation
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20 Rev.2.0/06.12
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 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 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.
ML-G Operation
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Rev.2.0/06.12 21
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.
ML-G Maintenance
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22 Rev.2.0/06.12
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.


ML-G Operation
_____________________________________________________________________________________________________
Rev.2.0/06.12 23
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 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 CO
2
-Filter-Kit.
3. Close the valve on the gas bottle tightly.

NOTE


Monitoring of
abdominal pressure
Monitoring of
abdominal pressure
Operational abdominal
pressure reached, low
flow rate enabled
ML-G Maintenance
_____________________________________________________________________________________________________
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 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 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. 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!

ML-G Maintenance
_____________________________________________________________________________________________________
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 for
insufflation, 1x3m/1x0,1m
In tube cleaning
machine
Steam sterilization;
134C, 3 bar, 5 min
670-95301
Silicone tube set for irrigation,
1x3m/ 1x1m
In tube cleaning
machine
Steam sterilization;
134C, 3 bar, 5 min
670-95312
Tube connection (LUER-
Lock), male
Manual
Steam sterilization;
134C, 3 bar, 5 min
670-95350
Veress needle, 2 mm,
length 150 mm, stainless steel
Manual
Steam sterilization;
134C, 3 bar, 5 min
670-95351
Veress needle, 2 mm,
length 100 mm, stainless steel
Manual
Steam sterilization;
134C, 3 bar, 5 min
670-95352
Veress needle, 2 mm,
length 120 mm, Edelstahl
Manual
Steam sterilization;
134C, 3 bar, 5 min
675-11202 Adaptor for insufflation Manual
Steam sterilization;
134C, 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.

ML-G Maintenance
_____________________________________________________________________________________________________
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 front
panel light up when the device is
switched on
Check if the mains plug is connected to
the socket and the device input.
Check the mains fuses on the rear panel
of the device. If they are interrupted
contact your local MGB Endoskopische
Gerte 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.

ML-G Notes
_____________________________________________________________________________________________________
27 Rev.2.0/06.12









ML-G Notes
_____________________________________________________________________________________________________
28 Rev.2.0/06.12
ML-G Maintenance
_____________________________________________________________________________________________________
Rev.2.0/06.12 29



MGB Endoskopische Gerte GmbH Berlin
Customer Service
Schwarzschildstrae 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