Copyright 2012 MGB Endoskopische Gerte GmbH Berlin Rev.2.0 / 06.12
ML-G Table of contents _____________________________________________________________________________________________________ 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 _____________________________________________________________________________________________________ 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 _____________________________________________________________________________________________________ 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 _____________________________________________________________________________________________________ 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 _____________________________________________________________________________________________________ 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 _____________________________________________________________________________________________________ 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 _____________________________________________________________________________________________________ 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 _____________________________________________________________________________________________________ 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
* 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 _____________________________________________________________________________________________________ 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.
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 _____________________________________________________________________________________________________ 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
ML-G Warranty _____________________________________________________________________________________________________ 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 _____________________________________________________________________________________________________ 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 _____________________________________________________________________________________________________ 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 _____________________________________________________________________________________________________ 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 _____________________________________________________________________________________________________ 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 _____________________________________________________________________________________________________ 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 _____________________________________________________________________________________________________ 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 _____________________________________________________________________________________________________ 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 _____________________________________________________________________________________________________ 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 _____________________________________________________________________________________________________ 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 _____________________________________________________________________________________________________ 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.
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