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KLS Martin maXium smart C, Инструкция по эксплуатации

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Instructions for Use 

maxium® smart C Electrosurgery Unit with maxium® smart Beam 

8

 

Revision 1 

1

 

Notices Concerning this Document 

1.1

 

Safety 

 

 

Non-observance of this document can lead to serious or even lethal patient injury! 

Improper handling and care as well as non-intended use can lead to premature wear and/or pose a risk to 
patients and users! 
It is the operator’s responsibility to ensure that all personnel handling the product have understood and 
do observe the notes and instructions in this document. 

 

•

 

Every user is required to read this document completely and follow it carefully. 

•

 

In particular, be sure to heed all cautions, warnings and danger notices. 

•

 

Keep this document accessible to users at all times. 

 

1.2

 

Terms & Acronyms 

 

Designation 

Description 

EMC 

Electromagnetic compatibility 

G-grades 

Gradation Levels 

HF 

High Frequency 

LUP 

Last Used Program 

MABS 

Martin Argon Beamer System 

NE 

Neutral electrode 

PCS 

Patient Control System 

TUR 

Transurethral Resection 

W 

Watt 

Vac 

Smoke Evacuator 

 

Содержание maXium smart C

Страница 1: ...d according to UL 60601 1 2003 CAN CSA C22 2 No 601 1 M90 maxium smart C Electrosurgery Unit with maxium smart Beam Instructions for Use 90 046 52 10 Revision 1 Date of Release 2017 10 Valid from soft...

Страница 2: ...a situation which if not avoided will result in death or serious injury Follow Instructions for Use Reference number for ordering Gebr der Martin products item number Serial number Store in a dry pla...

Страница 3: ...on for the neutral electrode Neutral electrode insulated against ground floating Symbol for classification of the unit as type CF The unit is defibrillation proof CAUTION High voltage high frequency c...

Страница 4: ...Preface 13 4 2 Monopolar application of HF current 14 4 2 1 Monopolar cutting 14 4 2 2 Monopolar coagulation 14 4 2 3 Neutral electrode 15 4 3 Bipolar application of HF current 16 4 3 1 Bipolar cutti...

Страница 5: ...Use of two electrosurgical devices on one patient 29 6 Functions 29 6 1 Overview 29 6 2 Connections on the Front 32 6 2 1 Monopolar connections 32 6 2 2 Bipolar connections 33 6 2 3 Neutral electrode...

Страница 6: ...rgon Filling Level 51 9 7 Automatic Functions of Bipolar Coagulation 51 9 8 Information about the limitations of the auto start function 52 10 Using the maxium smart C 53 10 1 General Information 53 1...

Страница 7: ...essages during Self Test 107 13 2 Messages in Case of Activation Errors 109 13 3 Input Feedback 110 13 4 Messages in Connection with Programs 111 13 5 Messages from the Argon Beamer and the Fume Sucti...

Страница 8: ...t all personnel handling the product have understood and do observe the notes and instructions in this document Every user is required to read this document completely and follow it carefully In parti...

Страница 9: ...ly implemented This ensures that it is always clear which software statuses are covered by this document 1 4 Symbols Used in this Document Throughout this document important information such as genera...

Страница 10: ...9 7461 706 193 info klsmartin com www klsmartin com 2 2 Hotline Should you have any questions on how to handle the unit product or question on its clinical application please do not hesitate to contac...

Страница 11: ...or maxium smart Cart REF 80 048 01 04 Isolating transformer maxium smart Cart REF 80 048 02 04 Device holder for maxium smart devices REF 80 048 03 04 Gas cylinder holder for maxium smart Cart REF 80...

Страница 12: ...pliance will void any liability claim against Gebr der Martin 3 Intended Use 3 1 Intended use of the maxium smart C The maxium smart C electrosurgery unit hereinafter referred to as the maxium smart C...

Страница 13: ...igh frequency HF electricity has been known for more than a century As early as the 1890s Tesla Nernst and d Arsonval conducted first experiments into the physiological effects of currents with high f...

Страница 14: ...s Unintended concentrations of the current density may result This is why the anatomical features of the operation field and its surroundings must be taken into account Moreover the current flowing th...

Страница 15: ...able electrodes The neutral electrodes consist of soft electrically conductive plastic material which can easily adapt to the body contour The reusable neutral electrodes are equipped with a permanent...

Страница 16: ...roblems resulting from formation of an extensive flow field are avoided in bipolar application 4 3 1 Bipolar cutting In contrast to monopolar cutting in bipolar cutting the HF current flows as in bipo...

Страница 17: ...c interference from electrosurgical devices may disturb or completely block pacemakers or other active implants For further information refer to section 5 5 page 25 5 1 Risks from Stray Currents In th...

Страница 18: ...ing and contact coagulation currents are used while it is very low in purely bipolar application 5 1 2 High frequency leakage currents Wherever a circuit conducts high AC voltage against the ground po...

Страница 19: ...larly high where high voltage monopolar currents are used and in particular with cutting currents and sparking coagulation currents With the bipolar currents of the maxium however it is low 5 1 4 Meas...

Страница 20: ...ering the patient from the active electrode seems to decrease very quickly from the contact point of the active electrode the HF current then flowing to the neutral electrode at low current density In...

Страница 21: ...scle layer with good conductivity in the electrosurgical sense However in the area of the upper limbs which are a preferred application site for the neutral electrode particular in obese patients ther...

Страница 22: ...ffected Particularly for longer operation times it must be made sure that the patient does not lie on the cable connection clip of the neutral electrode risk of pressure necrosis The current paths in...

Страница 23: ...Under a normal atmosphere these substances are usually self extinguishing and cannot be ignited by the arc at the active electrode Under an oxygen rich atmosphere however they are combustible unless m...

Страница 24: ...ssor in practice arcing of the surgical glove occurs frequently at the point where the compressor is held The high voltage coagulation currents may cause corona discharges between the supply cable of...

Страница 25: ...tored using suitable technology A defibrillator as well as an external pacemaker should be kept ready for use Select the lowest possible output power on the electrosurgery unit Do not use the active e...

Страница 26: ...argon into the underlying tissue emphysema In tissue structures where a skin layer is located above a closed tissue layer or which several layers of skin overlay each other argon may be insufflated be...

Страница 27: ...its inertness argon unlike carbon dioxide which is also used in medical technology does not affect gas exchange in the lungs but it can displace the respiratory air if the concentration becomes very...

Страница 28: ...ing it to an integrated electromedical system attention must be paid to the following points Accessories to be connected to the analog and digital interfaces of the unit must demonstrably satisfy the...

Страница 29: ...field The total power of the simultaneously applied currents must not exceed 400 W 6 Functions 6 1 Overview The maxium smart C is a microprocessor controlled high frequency surgery device according to...

Страница 30: ...ns for Use maxium smart C Electrosurgery Unit with maxium smart Beam 30 Revision 1 e i m socket modules Fig 6 1 maxium with m i and e socket modules Symbols on maxium smart C Refer to Symbol Explanati...

Страница 31: ...t port 9 Channel display Coagulation for bipolar HF output port 10 Channel display Coagulation for monopolar HF output ports 11 Selection Service Setup 12 ON OFF key 13 Display VAC connected 14 Status...

Страница 32: ...plain 4 mm connector banana plug For this plug use the right socket Insertion into either of the neighboring control contacts will cause malfunction Risk of injury from unauthorized accessories On th...

Страница 33: ...ol contacts will cause malfunction 6 2 2 Bipolar connections The socket of the socket module of the m version is suitable for standard instruments by Gebr der Martin The socket can be used to connect...

Страница 34: ...Rear 6 3 1 Foot switch connections Two foot switches can be connected to the maxium smart C One double pedal foot switch at the connection socket 18 Fig 6 1 one single pedal foot switch at the connec...

Страница 35: ...usly with the regular use In addition the installation and version notes of the manufacturers of these systems apply Other PC systems may be connected only for servicing and as long as the device is n...

Страница 36: ...m smart C is set to display the last used program after each switching on However in the Service menu the base program can be defined as autostart program factory default see section 10 6 7 Service pa...

Страница 37: ...nal spray coagulation During cutting argon can flow around the cutting electrode as a shielding gas displacing atmospheric oxygen and thereby reducing the formation of combustion products In both case...

Страница 38: ...applicators comprise particularly thin lumens The gas flow is activated synchronously with the HF current Here the maxium smart C which also supplies power to the maxium smart Beam activates the latt...

Страница 39: ...ive cap from the angle valve and screw on the pressure reducer Tighten the knurled screw only as far as manually possible without effort Only then open the angle valve of the cylinder at least half a...

Страница 40: ...h a purity of more than 99 998 This purity is per se not required for the process of the maxium smart Beam But only these high purity gases primarily intended for analytics are filled into pressure cy...

Страница 41: ...rilizable applicator which will hold back potential germs with the exception of viruses 7 2 Instruments Electrode Handles Electrodes Foot Switches and Cables for maxium and maxium smart Beam The maxiu...

Страница 42: ...ng network then this can be done using the connection pin on the rear via the equipotential bonding cable REF 80 260 50 04 This cable is optional and not included in the scope of delivery of the maxiu...

Страница 43: ...stem components are stacked one upon the other with the beamer below and connected to each other by the interlocking connections Place the maxium smart Beam on the front edge of the mounting plate 1 o...

Страница 44: ...ressure reducer Tighten the knurled screw of the pressure reducer only manually Snap the hose of the pressure reducer onto the argon inlet at the rear of the beamer If the angle valve of the pressure...

Страница 45: ...connect the maxium smart C and the maxium smart Beam to each other For installation a device holder REF 80 048 03 04 must be ordered in addition to the maxium smart Cart REF 80 048 00 04 The lower par...

Страница 46: ...er with an error number Typical messages during the self test of the maxium smart C include the following Self test XX switch engaged upon unit startup During self test the maxium has received a signa...

Страница 47: ...gauge at the pressure reducer indicates a pressure of less than 10 bar operation with the residual pressure is not expedient The cylinder should never be completely emptied Argon Beamer E55 59 Offset...

Страница 48: ...or a capacitive neutral electrode must be used Also in cases where bipolar application is intended but additional application of monopolar electricity is likely in case of complications a neutral ele...

Страница 49: ...a tried and tested system for monitoring the connection and body contact of neutral electrodes The PCS automatically detects whether a connected neutral electrode is single piece or two piece user in...

Страница 50: ...ow field the patient has a particularly high electrical resistance This may be due to the age of the patient his her ethnic background or other reasons Generally it is to be expected that in such a ca...

Страница 51: ...ubt the display of the pressure gauge is authoritative 9 7 Automatic Functions of Bipolar Coagulation The bipolar coagulation current types BiCoag and Neptun can be activated either via a foot switch...

Страница 52: ...scopy the auto start function carries the risk of burns and coagulation necroses due to unnoticed and unintended automatic activation of HF current in the placement of endoscopic instruments For this...

Страница 53: ...improve the clarity of the screen layout channels not required for the current application can be deselected For this purpose touch the corres ponding area on the screen for at least two seconds The c...

Страница 54: ...an be confirmed by tapping the check mark or canceled by tapping the cross 10 3 2 Selecting the current The maxium smart C is equipped with various current types for monopolar and bipolar applications...

Страница 55: ...3 4 Selecting the Activation Type Foot Switch The maxium smart C can be activated via finger switches on the instrument via foot switches and for bipolar coagulation currents also automatically While...

Страница 56: ...by tapping the check mark or canceled by tapping the cross If an already assigned foot switch is assigned to another channel it is removed from the previous channel 10 4 Navigation within the Programs...

Страница 57: ...for which they are particularly suitable The operator can use modify and save or delete these programs or create custom programs 10 5 1 Base program The maxium smart C can be set to automatically sta...

Страница 58: ...confirm by tapping the check mark The settings of the program are applied on the screen Selection via the Program settings menu Press the symbol to open the Setup Press Program settings Press Select p...

Страница 59: ...gram The base program and programs with the padlock icon can be neither deleted nor overwritten Changes can only be saved under a different program name see section 10 5 4 Saving a program under a new...

Страница 60: ...to use different settings during the operation without the need for switching to be made by a non sterile person directly at the maxium smart C It is useful where there is a need to change any settin...

Страница 61: ...mark it Press Link to a SWAP progr Find the second program and mark it Confirm by tapping the check mark or Apply link The linkage of the two programs is immediately shown in the program list where t...

Страница 62: ...ssage History section 10 6 10 page 67 Help section 10 6 9 page 67 Interface Language section 10 6 8 page 66 Service section 10 6 7 page 66 Hotline section 10 6 6 page 66 Some settings will affect the...

Страница 63: ...licable standard IEC 60601 2 2 prescribes a minimum of 40 dB A For this reason reduction of the volume to less than 40 is not possible This function is used to adjust the volume of the alarm tone The...

Страница 64: ...can be adjusted to adapt it to the environment For this purpose a day or night design can be selected With the function Brightness brightness of the screen can be set to a minimum value of 10 The cha...

Страница 65: ...opolar current types additionally the maximum HF output power that can be selected is limited The function Mega Soft NE allows use of capacitive large surface NEs for operations on neonates or infants...

Страница 66: ...the base program where the beamer parameters will always be displayed There deactivation of beamer operation causes only a temporary hiding until the unit is turned off and on again 10 6 6 Hotline Un...

Страница 67: ...6 9 Help Help elements such as the Instructions for Use or video clips explaining the operation of the device or accessory can be found here 10 6 10 Message History All data will be displayed here su...

Страница 68: ...results are achieved independent of cutting depth The delivered power will usually be well below the selected power level which is to be understood only as setting with power reserve However the selec...

Страница 69: ...fect setting Fundamental frequency 404 kHz Crest factor 1 5 Output curves Output power versus set power Repetitive peak output voltage versus set effect HF power in watts HF voltage in volts peak Sett...

Страница 70: ...ightly varied The Blend Cut current can be used universally wherever extensive active electrodes are to be used and a certain hemostasis effect immediately during cutting is expected For needle electr...

Страница 71: ...ect setting Fundamental frequency 404 kHz Crest factor 2 6 5 5 Output curves Output power versus set power Repetitive peak output voltage versus set effect HF power in watts HF voltage in volts peak S...

Страница 72: ...n be set to up to 400 W At a power of more than 150 W the risks of burns described in section 5 1 5 2 and 5 3 will increase The safety measures described therein shall be applied with increased dilige...

Страница 73: ...ffect setting Fundamental frequency 404 kHz Crest factor 1 5 Output curves Output power versus set power Repetitive peak output voltage versus set effect HF power in watts HF voltage in volts peak Set...

Страница 74: ...rent can be set to up to 250 W At a power of more than 150 W the risks of burns described in section 5 1 5 2 and 5 3 will increase The safety measures described there shall be applied with increased d...

Страница 75: ...setting Fundamental frequency 404 kHz Crest factor at 600 3 5 2 Output curves Output power versus set power Repetitive peak output voltage versus set effect HF power in watts HF voltage in volts peak...

Страница 76: ...wer reserve However the selected power will never be exceeded Soft Cut can be used for the work with electrode arrangements such as needle or with wire loop electrodes as well as for portio conisation...

Страница 77: ...ect setting Fundamental frequency 500 kHz Crest factor 1 5 Output curves Output power versus set power Repetitive peak output voltage versus set effect HF power in watts HF voltage in volts peak Setti...

Страница 78: ...ith them Thus always consistent cutting results are achieved independent of cutting depth The delivered power will usually be well below the selected power level which is to be understood only as sett...

Страница 79: ...fect setting Fundamental frequency 404 kHz Crest factor 1 4 Output curves Output power versus set power Repetitive peak output voltage versus set effect HF power in watts HF voltage in volts peak Sett...

Страница 80: ...observed Thus the tissue at the point of contact will be strongly desiccated slight tissue carbonization will take place Due to quickly occurring coagulation the effective depth is limited Using the e...

Страница 81: ...ect setting Fundamental frequency 404 kHz Crest factor 3 1 3 7 Output curves Output power versus set power Repetitive peak output voltage versus set effect HF power in watts HF voltage in volts peak S...

Страница 82: ...ing the voltage can be changed and thus the hemostatic effect slightly varied Basically under the condition that the same amount of HF energy is required the following apply Low penetration Short appl...

Страница 83: ...t maximum effect setting Fundamental frequency 404 kHz Crest factor 3 4 7 5 Output curves Output power versus set power Repetitive peak output voltage versus set effect HF power in watts HF voltage in...

Страница 84: ...d Basically under the condition that the same amount of HF energy is required the following apply Low penetration Short application time and correspondingly high HF output power Deep penetration Long...

Страница 85: ...ndamental frequency 382 kHz Crest factor 2 6 3 2 Output curves Output power versus set power Repetitive peak output voltage versus set effect HF power in watts HF voltage in volts peak Setting Effect...

Страница 86: ...onization will take place Due to quickly occurring coagulation the effective depth is limited Using the effect setting the voltage can be changed and thus the hemostatic effect slightly varied Basical...

Страница 87: ...undamental frequency 412 kHz Crest factor 4 4 5 0 Output curves Output power versus set power Repetitive peak output voltage versus set effect HF power in watts HF voltage in volts peak Setting Effect...

Страница 88: ...ied Danger of injury by ruptures Active accessories to be used with this current must be able to withstand an HF voltage of at least 2 500 V depending on the selected effect For the special risks pose...

Страница 89: ...ect setting Fundamental frequency 420 kHz Crest factor 5 2 5 9 Output curves Output power versus set power Repetitive peak output voltage versus set effect HF power in watts HF voltage in volts peak S...

Страница 90: ...hus the hemostatic effect slightly varied For contact coagulation this current is less well suited Danger of injury by sparking Active accessories to be used with this current must be able to withstan...

Страница 91: ...ndamental frequency 500 kHz Crest factor 4 2 7 4 Output curves Output power versus set power Repetitive peak output voltage versus set effect HF power in watts HF voltage in volts peak Setting Effect...

Страница 92: ...is selected for either of the coagulation channels of the M output ports it will appear also on the other output port The power can be set only to the same value on both channels If the current of one...

Страница 93: ...t maximum effect setting Fundamental frequency 404 kHz Crest factor 3 4 7 5 Output curves Output power versus set power Repetitive peak output voltage versus set effect HF power in watts HF voltage in...

Страница 94: ...ne via the blue switches finger or foot If this current is selected for either of the coagulation channels of the M outputs it will appear also on the other output port The power can be set only to th...

Страница 95: ...ge 4 500 Vp Fundamental frequency 500 kHz Crest factor 4 2 7 4 Output curves Output power versus set power Repetitive peak output voltage versus set effect HF power in watts HF voltage in volts peak S...

Страница 96: ...s and large application distance Using the effect setting the voltage can be changed and thus the hemostatic effect slightly varied This current can be selected if a maxium smart Beam is connected Ris...

Страница 97: ...ndamental frequency 500 kHz Crest factor 4 2 7 4 Output curves Output power versus set power Repetitive peak output voltage versus set effect HF power in watts HF voltage in volts peak Setting Effect...

Страница 98: ...rime benefits Bipol Pure Cut provides a smooth cut with a low degree of eschar formation and low hemostasis effect Using the effect setting the voltage can be changed and thus the hemostatic effect sl...

Страница 99: ...Fundamental frequency 404 kHz Crest factor 1 5 Output curves Output power versus set power Repetitive peak output voltage versus set effect HF power in watts HF voltage in volts peak Setting Effect Ou...

Страница 100: ...he blades In addition to tissue coagulation synchronously with cutting contact coagulation can also be performed in which the slightly opened blades touch the location to be coagulated in a flat or po...

Страница 101: ...Fundamental frequency 457 kHz Crest factor 1 5 Output curves Output power versus set power Repetitive peak output voltage versus set effect HF power in watts HF voltage in volts peak Setting Effect Ou...

Страница 102: ...lication time and correspondingly high HF output power Deep penetration Long application time and correspondingly low HF output power The start delay for Auto Start can be varied see section 10 3 4 Se...

Страница 103: ...Fundamental frequency 457 kHz Crest factor 1 5 Output curves Output power versus set power Repetitive peak output voltage versus set effect HF power in watts HF voltage in volts peak Setting Effect Ou...

Страница 104: ...pleen kidney However it can also be beneficial in other applications in visceral surgery or neurosurgery The supply of liquid before coagulation allows the origin of the bleeding to be localized more...

Страница 105: ...Fundamental frequency 457 kHz Crest factor 1 5 Output curves Output power versus set power Repetitive peak output voltage versus set effect HF power in watts HF voltage in volts peak Setting Effect Ou...

Страница 106: ...fit for use must be withdrawn from service Never sterilize the unit Always disconnect the unit from the supply before cleaning and disinfecting it No liquid must be allowed to enter the unit Therefore...

Страница 107: ...s again disconnect the foot switch from the unit and turn the latter off and on again If the self test is now completed successfully the circuit of the instrument is shorted otherwise there is a malfu...

Страница 108: ...re is rather a short circuit within the instrument If the unit remains in self test mode and does not proceed beyond it after switching off and on again either then there is a malfunction in the unit...

Страница 109: ...hannel M Please swap the connections A monopolar instrument was activated via foot switch which is connected to the port output M via a single 4 mm connector This plug is not connected to the leftmost...

Страница 110: ...etting Mega Soft NE in the Setup menu see section 10 6 4 page 65 Single piece NE is prohibited by Setup hence NE error The unit has detected connection of a single piece neutral electrode although thi...

Страница 111: ...erwriting a program Program memory full first delete a program Up to 50 programs can be stored in the maxium smart C This message indicates that the capacity of the memory has been reached It is neces...

Страница 112: ...at the argon reserve is running low Argon Beamer E52 Inlet pressure too high The pressure at the gas inlet of the maxium smart Beam is higher than 4 5 bar If the unit is supplied via a MABS pressure r...

Страница 113: ...t may be a new instrument which is not known to the installed software yet In this case a software update will be necessary If it is an instrument which was always detected before then connect the ins...

Страница 114: ...le in a version suitable for the unit Updated instructions for use can be obtained from the Martin Service Center The software version number VX xxx shown on the startup screen upon switching on of th...

Страница 115: ...f a maxium smart Beam first switch off the maxium smart C disconnect any argon gas supply connection from the maxium smart Beam and then switch on the unit again The base program appears on the screen...

Страница 116: ...the protective grounding conductor of the mains cable during simulation of an interruption of the near ground phase N causes the unit to switch off This value must not exceed 1 5 the value of the init...

Страница 117: ...rt function may be selected Single fault condition PE conductor Measurement of the current from the instrument connections M B and NE in non activated condition to the ground with the protective condu...

Страница 118: ...o pollutants other than these combustion products will be formed In the interest of low energy use we recommend switching off the unit during longer treatment breaks 15 3 Disposal of the Device In des...

Страница 119: ...level Electromagnetic environment Guidelines HF emissions according to CISPR 11 Group 2 The device must emit electromagnetic energy in order to fulfill its intended function Nearby electronic units m...

Страница 120: ...l or hospital environment Surges according to IEC 61000 4 5 1 kV symmetrical voltage 2 kV asymmetrical voltage 1 kV symmetrical voltage 2 kV asymmetrical voltage Mains power quality should be that of...

Страница 121: ...ded separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Inte...

Страница 122: ...pment Separation distance according to frequency of transmitter in m Rated maximum output P of transmitter in watts 150 kHz 80 MHz P d 6 0 80 MHz 800 MHz P d 4 0 800 MHz 2 5 GHz P d 7 0 0 01 0 06 0 04...

Страница 123: ...ith a single unit configuration Two monopolar and one bipolar output ports Monopolar arc free cutting up to max 400 W Effect adjustment regardless of power setting Bipolar cutting with bipolar marCut...

Страница 124: ...G 5 20 mm Signal level HF display 55 dB A adjustable 45 60 dB Alarm 65 dB A Weight 9 kg Radio interference suppression The maxium smart C meets the requirements of IEC 60601 1 2 also in conjunction wi...

Страница 125: ...W Blend Cut up to 30 W Forced Prep up to 30 W Super Cut up to 30 W Spray up to 30 W Contact Coag up to 30 W Forced Coag up to 30 W Argon Beam up to 30 W The bipolar current types are fully available...

Страница 126: ...gether with the HF generator of the maxium smart C Type Application Part CF defibrillation proof Operating mode INT 10s 30s Weight 3 5 kg Radio interference suppression See section 17 2 The maxium sma...

Страница 127: ...Instructions for Use maxium smart C Electrosurgery Unit with maxium smart Beam Revision 1 127...

Страница 128: ...artin com Gebr der Martin GmbH Co KG Moscow Russia Tel 7 499 792 76 19 russia klsmartin com Gebr der Martin GmbH Co KG Dubai United Arab Emirates Tel 971 4 454 16 55 middleeast klsmartin com KLS Marti...

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