KLS Martin maXium smart C Instructions For Use Manual
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KLS Martin maXium smart C Instructions For Use Manual

Electrosurgery unit with beam
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Front Cover
English
Tested according to:
UL 60601-1:2003
CAN/CSA C22.2 No.601.1-M90
90-046-52-10
Revision 1
Date of Release: 2017-10
maxium® smart C Electrosurgery Unit with
maxium® smart Beam
Instructions for Use
Valid from software version V1.3.35.3017

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Summary of Contents for KLS Martin maXium smart C

  • Page 1 Front Cover maxium® smart C Electrosurgery Unit with English maxium® smart Beam Instructions for Use Tested according to: UL 60601-1:2003 CAN/CSA C22.2 No.601.1-M90 90-046-52-10 Revision 1 Date of Release: 2017-10 Valid from software version V1.3.35.3017...
  • Page 2 Symbol Explanation Safety alert symbol CAUTION Indicates a situation which, if not avoided, could result in minor or moderate injury. WARNING Indicates a situation which, if not avoided, could result in death or serious injury. DANGER Indicates a situation which, if not avoided, will result in death or serious injury.
  • Page 3 Connection 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 currents Manufacturer Revision 1...

  • Page 4: Table Of Contents

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Contents Notices Concerning this Document ................8 Safety........................... 8 Terms & Acronyms ......................8 Validity of this Document....................9 Symbols Used in this Document ..................9 Product Liability and Warranty................10 General Information ......................
  • Page 5 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Risks from High Voltage ....................24 Risks from Electromagnetic Interference ................. 25 Risks from Pressure Vessels and Argon Gas Flow ............. 25 5.6.1 Pressure vessels ..........................25 5.6.2 Embolisms and emphysema ......................
  • Page 6 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Installation of the maxium® smart C and the maxium® smart Beam ....42 Standalone Installation of the maxium® smart C ............. 42 Installation of the maxium® smart C with maxium® smart Beam ........43 Installation on the maxium®...
  • Page 7 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam 10.6.6 Hotline ............................66 10.6.7 Service ............................66 10.6.8 Interface Language ......................... 66 10.6.9 Help ..............................67 10.6.10 Message History ..........................67 Currents, their Properties and Technical Data ............68 11.1 Monopolar Cutting Currents .....................

  • Page 8: Notices Concerning This Document

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Notices Concerning this Document 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.

  • Page 9: Validity Of This Document

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Validity of this Document This document is valid from software version V1.3.35.3017. If older software versions are used, it may be that newer functions described in this document are not available. Via the information provided on the starting screen, the maxium®...

  • Page 10: Product Liability And Warranty

    We are the manufacturer of this product: Gebrüder Martin GmbH & Co. KG A company of the KLS Martin Group KLS Martin Platz 1 · D-78532 Tuttlingen · Germany Postfach 60 · D-78501 Tuttlingen · Germany Tel. +49 7461 706-0 · Fax +49 7461 706-193 info@klsmartin.com ·...

  • Page 11: Scope Of Delivery

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Scope of Delivery Electrosurgery unit • maxium® smart C – m-Version, REF 80-043-00-04 or – i-Version, REF 80-043-01-04 or – e-Version, REF 80-043-02-04 • Mains cable, country-specific variant •...

  • Page 12: Intended Use

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Maintenance information The product may only be repaired by Gebrüder Martin or a qualified person or firm expressly authorized by Gebrüder Martin to perform such work. Modifications of the unit can lead to unforeseeable risks and are therefore not allowed. If the repair is carried out by a person or firm specially authorized by Gebrüder Martin, the operator of the product is required to obtain from the repairer a certificate with details about the nature and scope of the repair work done.

  • Page 13: Intended Use Of The Maxium® Smart Beam

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Intended use of the maxium® smart Beam The maxium® smart Beam by Gebrüder Martin is a gas flow control unit for generation of a defined gas flow in the range of 0–12 l/min which can be operated only in connection with the electrosurgery units maxium®.

  • Page 14: Monopolar Application Of Hf Current

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Monopolar application of HF current In monopolar application, the HF current is introduced into the operation field via an electrode on an electrode handle or other instrument. This so- called active electrode has a small surface.

  • Page 15: Neutral Electrode

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam In the second type of coagulation, the energy enters the tissue not directly from the electrode, but by arcing through a vapor or air layer, due to high electrical voltage. Here the energy is converted essentially not in the tissue itself, but on its surface.

  • Page 16: Bipolar Application Of Hf Current

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Bipolar application of HF current In bipolar application, the current flows only between two electrodes in close spatial vicinity, which are connected to the HF generator with both poles. A flow field is formed which is essentially restricted to the contact zone of the two electrodes with the tissue.

  • Page 17: Risk Minimization And Safety Measures

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Risk Minimization and Safety Measures Risk of serious injury in case of improper use! Electrosurgery units comprise generators for high-frequency electrical energy, which can have high amperage and voltage by design. In order to avoid hazards to the patient, the operators and third parties, the procedure must be applied carefully.

  • Page 18: Patient Shunts

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam 5.1.1 Patient shunts The spatial separation of operation field and neutral electrode causes a very extensive flow field to be formed. Here the currents do not necessarily all have to flow within the body.

  • Page 19: Leakage Currents To Other Medical Devices

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam The risk of burns is particularly high where high voltage monopolar currents are used, and in particular with cutting currents and sparking coagulation currents. Especially when using monopolar HF currents during endoscopic operations, consider that due to the capacitive connection between an electrosurgical instrument and other electrically conductive components (trocar, instrument shafts, ...) used in endoscopy, working current can be present and can cause tissue burns when tissue comes into contact with such parts.

  • Page 20: Risks From Current Concentration

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam To prevent high current densities by leakage currents to other medical devices, note the following: • When simultaneously using electrosurgery and monitors on the same patient, use only such systems where possible leakage currents are reduced to non-hazardous strength by constructive measures, e.g.
  • Page 21 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Conversely, metallic implants directly under the neutral electrode may act as a collecting lens for the current flowing to the neutral electrode. They cause current concentrations entailing a risk of burns. The current concentration caused by the implant may lead to local overheating which presents an additional risk for the integrity of the implant itself.

  • Page 22: Current Condensation Inside The Body

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam 5.2.2 Current condensation inside the body Some anatomical structures are of filamentous nature (e.g. fallopian tubes) or connected to the body via filamentous structures (blood vessels, ducts). When monopolar HF current is used, the effect of the current may have adverse effects along the entire length of a filamentous structure or affect the connection to the body off the actual operation field,...

  • Page 23: Risks From Arcing And Sparking

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Risks from Arcing and Sparking Under the intended conditions of usage, at the active electrode electric arcs or sparks (arcs of very short duration) are formed which are capable of igniting combustible material. The plasma beam of the argon beamer is also capable of this.

  • Page 24: Risks From High Voltage

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam • In case of increased concentrations of oxygen and/or nitrous oxide in the area of the operation field, special care must be taken. • Remove bubbles of pyrolysis and electrolysis gas in body cavities by appropriate irrigation to avoid formation of significant accumulations.

  • Page 25: Risks From Electromagnetic Interference

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Risks from Electromagnetic Interference Radios, cell phones, or other emitters in the immediate vicinity of the unit may affect the safe operation of the same. For minimum distances from emitting devices see section 16 “Guidelines and Manufacturer’s Declaration on Electromagnetic Compatibility (EMC)”, page 119.

  • Page 26: Embolisms And Emphysema

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam • Use only argon as working gas! The pressure reducer can be connected to other pressure cylinders for so-called special gases such as carbon dioxide as well! Make sure that the cylinder which the pressure reducer is to be connected to really does contain argon.

  • Page 27: Contamination Of The Operation Field

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam To prevent this, observe the following rules: • Select low gas flow rate! Use endosurgical applicators working with low gas flow rates of no more than of 3 l/min. •...

  • Page 28: Combination With Other Devices

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam • If an activation sound is audible although no current has been intentionally activated, then there is a system malfunction. The ON/OFF key allows turning off the unit so that it cannot emit any energy. The activation sound always accompanying activation of an HF current is an important safety element.

  • Page 29: Use Of Two Electrosurgical Devices On One Patient

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam 5.8.4 Use of two electrosurgical devices on one patient Basically, due to the increased risk of accidental burns by high-frequency currents two electrosurgical units should be used on one patient only if medical requirements necessitate this. The following rules are to be observed in the concomitant operation of two electrosurgical devices: •...
  • Page 30 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam socket modules Fig. 6-1: maxium® with m, i and e socket modules Symbols on maxium® smart C: Refer to “Symbol Explanation”, page 2. Revision 1...
  • Page 31 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Monopolar HF output port 1 Monopolar HF output port 2 Bipolar HF output Activation indicators for monopolar HF output ports Activation indicators for bipolar HF output port Touchscreen Channel display Cutting for monopolar HF output ports Channel display Cutting for bipolar HF output port Channel display Coagulation for bipolar HF output port...

  • Page 32: Connections On The Front

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Connections on the Front The maxium® smart C by Gebrüder Martin can be equipped with three different versions (m, i and e) of socket modules for the HF output ports, see section 6.1 “Overview”, page 29. 6.2.1 Monopolar connections In the socket module of the m-version, the sockets M are suitable...

  • Page 33: Bipolar Connections

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam In the socket module of the e-version, the sockets M are suitable for instruments with 5-mm plug (coaxial circular connector with 5-mm inner conductor). The following cables can be connected here: •...

  • Page 34: Neutral Electrode Connection

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam 6.2.3 Neutral electrode connection The connection socket (9, Fig. 6-1) for connection of the neutral electrode cable is suitable for a symmetrical (angular) plug according to US standard. Risk of injury due to failure of power control! Extensive neutral electrodes which are not in direct contact with the patient’s skin (so-called capacitive neutral electrodes) limit or disable the control of the HF output power for some monopolar cutting...

  • Page 35: Serial Interfaces

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam 6.3.3 Serial interfaces The MCB interface (22, Fig. 6-1) serves for linking to an integrated surgery system, as well as for the control of external accessories such as fume suction. Accessories to be connected to the analog and digital interfaces of the unit must demonstrably satisfy the applicable IEC specifications (e.g.

  • Page 36: Mains Connection

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam 6.3.5 Mains connection The maxium® smart C is equipped with a wide-range power supply, so that the nominal value of the mains voltage can be from 100 V to 240 V without need for switching the network connection.

  • Page 37: Accessories

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Accessories Only accessories approved by the manufacturer or compatible accessories may be used. maxium® smart Beam 7.1.1 General Information The maxium® smart Beam is an accessory for the maxium® smart C electrosurgery unit that serves to generate a defined gas flow in the range of 0–12 l/min.

  • Page 38: Control And Display Elements, Connections

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam With its regulator, the maxium® smart Beam controls the gas throughput so that at the patient end of the applicator the selected gas pressure will result. Different flow resistances of the applicators are auto- matically taken into account in the process and do not affect the value of the gas flow.

  • Page 39: Gas Supply

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam 7.1.3 Gas supply For the operation of the maxium® smart Beam, the noble gas argon is needed. Argon is available in cylinders of various sizes with a nominal filling pressure of 200 bar. For installation on the maxium®...

  • Page 40: Argon

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Never empty the cylinder completely! At a residual pressure of 30 bar or less, the cylinder should be replaced. Pay attention to indicator on the maxium® smart C screen! If the system is not used for an extended period of time, close the valve on the pressure cylinder to avoid argon loss from the system while it is not used.

  • Page 41: Instruments, Electrode Handles, Electrodes, Foot Switches And Cables For Maxium® And Maxium® Smart Beam

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam The gas supply at the electrode handle is part of a Luer-lock connection and to be connected to the socket (1, Fig. 7-1) on the front of the maxium® smart Beam. In order to flush out any air present in the applicator, by pressing the PURGE key (2, Fig.

  • Page 42: Installation Of The Maxium® Smart C And The Maxium® Smart Beam

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Installation of the maxium® smart C and the maxium® smart Beam Standalone Installation of the maxium® smart C The maxium® smart C is designed to be set up on a level surface such as a table or a shelf. Connection to a power outlet is established with the supplied mains cable to be inserted into the mains port on the backside.

  • Page 43: Installation Of The Maxium® Smart C With Maxium® Smart Beam

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Installation of the maxium® smart C with maxium® smart Beam Typically, the maxium® smart C and maxium® smart Beam system components are stacked one upon the other with the beamer below, and connected to each other by the interlocking connections.
  • Page 44 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam • To unmount the maxium® smart C and maxium® smart Beam, insert a round object into the opening provided for this purpose and simultaneously lift the device. Perform the gas installation as follows: •...

  • Page 45: Installation On The Maxium® Smart Cart

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Installation on the maxium® smart Cart For accommodation of the complete system consisting of maxium® smart Beam, maxium® smart C electrosurgery unit, argon cylinders and the respective accessories in a self- contained unit, Gebrüder Martin recommends installation on the maxium®...

  • Page 46: Commissioning Of The Maxium® Smart C And The Maxium® Smart Beam

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Commissioning of the maxium® smart C and the maxium® smart Beam General Information The maxium® smart C may be used only by persons trained in the proper and safe use of the unit. The Instructions for Use are to be adhered to in instruction and application.

  • Page 47: Switching On The Maxium® Smart Beam

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Switching on the maxium® smart Beam The maxium® smart Beam is fed and controlled by the maxium® smart C. When switched on, independently of the maxium® smart C it will perform a self-test, checking the functions of the gas flow control and the status of the argon gas supply.

  • Page 48: Connection Of The Active Electrodes

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Connection of the active electrodes Active electrodes, their sockets and lines must be examined for defects of the insulation before being connected. Active electrodes with insulation defects present a risk for the patient and the surgeon. If current types with high output voltages are to be used, it must be made sure that the accessories combined with the active electrode are approved for use with the potential voltage.

  • Page 49: Gebrüder Martin Patient Control System (Pcs)

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam • Do not apply the neutral electrode above implants or other metal parts, nor above bone protrusions or scarred tissue. If necessary, prepare the application site by cleaning and degreasing it; strong hair- growth is to be removed.
  • Page 50 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam During the time in which the neutral electrode is applied to the skin of the patient, the PCS will monitor the resistance of the skin. The lowest measured resistance is used as reference for the contact quality and represents the right- most position of the pointer.

  • Page 51: Argon Filling Level

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Argon Filling Level If an argon beamer is connected to the maxium® smart C and the current program comprises an argon current, a pressure cylinder with the remaining filling level is displayed on the bottom of the screen.

  • Page 52: Information About The Limitations Of The Auto-Start Function

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Information about the limitations of the auto-start function Danger of injury by burns! In endoscopic surgery, do not use the auto-start function! For technical reasons, a bipolar output cannot be associated with a cutting current and a coagulation current with auto-start function at the same time.

  • Page 53: Using The Maxium® Smart C

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Using the maxium® smart C 10.1 General Information To each instrument connection, on the screen a cutting channel as a yellow field and a coagulation channel as a blue field are assigned in horizontal direction. All settings of the device for clinical day-to-day operation are done via the touchscreen.

  • Page 54: Setting The Values For The Working Channels

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam 10.3 Setting the Values for the Working Channels The channel fields are used for • selecting the HF output power, page 54, • selecting the current, page 54, •...

  • Page 55: Setting The Effect

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam 10.3.3 Setting the Effect The performance of the maxium® smart C can be changed via setting the effect. For this purpose, there are several effect settings for all current types, which result in different degrees of hemostasis, regardless of the selected power.

  • Page 56: Navigation Within The Programs And Functions Of The Maxium® Smart C

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Bipolar cutting: • using the finger switch • using the yellow pedal • using the black pedal Bipolar coagulation: • using the finger switch • using the blue pedal •...

  • Page 57: Programming Settings

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam By pressing the respective display areas, the setting and menu area can be opened, which must then be confirmed by tapping the check mark. By pressing the cross, the higher-level menu item will be opened. Activation of HF current while any of the settings described above is being changed will cancel the operation automatically, since availability of HF current...

  • Page 58: Selecting Programs

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam 10.5.2 Selecting Programs There are two ways to select and activate a program stored in the unit: • via the list of recently used programs • via the Program settings menu Selection via the list of recently used programs (LUPs): •...

  • Page 59: Saving Modified Programs

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam 10.5.3 Saving modified programs Changes made to a program can be made permanent. • Press Save. • Confirm by tapping the check mark or the Return button • Press the symbol to open the Setup •...

  • Page 60: Deleting Programs

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam 10.5.5 Deleting programs To delete a program, proceed as follows: • Press the symbol to open the Setup • Press Program settings • Press Delete Program • Find the program to be deleted and mark it •...
  • Page 61 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam The name of this SWAP® program should reflect the link with the initial program. The assignment is done as follows: • Press the symbol to open the Setup •...

  • Page 62: The Setup Menu

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam 10.6 The Setup Menu In the Setup menu, various unit and service settings can be made: • Programming Settings (section 10.5, page 57) • Neutral electrode (section 10.6.4, page 65) •...

  • Page 63: Setting Sound Level

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam 10.6.1 Setting sound level In this menu, the volume of activation and alarm tones can be set. These settings are global. The function Activation tone volume serves to adjust the volume of the sound which indicates activation of an HF current.

  • Page 64: Setting Display

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam The maxium® electrosurgery unit is equipped with an automatic sound level increase function that increases the activation sound after a preset period of time. Options: 15, 30, 60 seconds, or Never. This function can serve to acoustically alert the user to unintentional activation of the HF current and thus to avoid possible burns.

  • Page 65: Neutral Electrode

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam 10.6.4 Neutral electrode In this menu, restrictions or permissions for certain features of neutral electrodes can be set. It can be determined whether the unit is to allow operation with single-piece as well as with two-piece electrodes, or with two-piece electrodes only.

  • Page 66: Argon Mode

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam If a SWAP program is to be created using a program with a specific NE, for safety reasons the specific NE is applied for the other program as well. This NE is then displayed in the other program as “modified”. Channels with current types that may potentially not be allowed are deactivated.

  • Page 67: Help

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam 10.6.9 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, such as: •...

  • Page 68: Currents, Their Properties And Technical Data

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Currents, their Properties and Technical Data 11.1 Monopolar Cutting Currents Pure Cut Pure Cut is a cutting current with a low proportion of coagulation. Since the edges of the cut are coagulated only weakly, a low hemostatic effect results.
  • Page 69 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Technical Data Power setting range: 1–400 W at 500 Ω Max. periodic HF output voltage: 900 V at maximum effect setting Fundamental frequency: 404 kHz Crest factor: Output curves Output power versus set power Repetitive peak output voltage versus set effect Setting...
  • Page 70 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Blend Cut Blend Cut is a cutting current with a moderate proportion of eschar formation. The wound edges are simultaneously coagulated during cutting, coagulating the extensive bleeding from transected capillaries immediately during cutting.
  • Page 71 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Technical Data Power setting range: 1–150 W at 800 Ω Max. periodic HF output voltage: 2,000 V at maximum effect 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...
  • Page 72 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Uro Pure Cut When cutting under irrigation fluid, the basic conditions differ fundamentally from those of open-surgery. Uro Pure Cut takes this into account and provides a cutting current with low hemostasis specifically for urology in TUR-P or TUR-B applications.
  • Page 73 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Technical Data Power setting range: 1–400 W at 800 Ω Max. periodic HF output voltage: 1,100 V at maximum effect setting Fundamental frequency: 404 kHz Crest factor: Output curves Output power versus set power Repetitive peak output voltage versus set effect Setting...
  • Page 74 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Uro Blend Cut When cutting under irrigation fluid, the basic conditions differ fundamentally from those of open-surgery. Uro Blend Cut takes this into account and provides a cutting current with concomitant hemostasis for applications such as TUR-P or TUR-B in urology or endometrium ablation.
  • Page 75 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Technical Data Power setting range: 1–150 W at 800 Ω Max. periodic HF output voltage: 2,000 V at maximum effect setting Fundamental frequency: 404 kHz Crest factor at 600 Ω: 3–5.2 Output curves Output power versus set power...
  • Page 76 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Soft Cut Soft Cut offers precise and smooth cutting specifically for the use of applicators with wires as active electrode, such as fine wire loops or needle electrodes. Thus this current causes only minimal injury to the tissue edge.
  • Page 77 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Technical Data Power setting range: 1–80 W at 400 Ω Max. periodic HF output voltage: 650 V at maximum effect setting Fundamental frequency: 500 kHz Crest factor: Output curves Output power versus set power Repetitive peak output voltage versus set effect Setting...
  • Page 78 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Argon Cut The Argon Cut current corresponds to the Pure Cut current with additional application of argon. Under an argon gas atmosphere, this current supports a cutting which causes even less eschar formation than Pure Cut.
  • Page 79 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Technical Data Power setting range: 1–400 W at 500 Ω Max. periodic HF output voltage: 900 V at maximum effect setting Fundamental frequency: 404 kHz Crest factor: Output curves Output power versus set power Repetitive peak output voltage versus set effect Setting...

  • Page 80: Monopolar Coagulation Currents

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam 11.2 Monopolar Coagulation Currents Forced Clamp The Forced Clamp coagulation current type is preferably applied indirectly via surgical instruments (e.g. hemostat, surgical forceps) for hemostasis. The needle, knife or lancet electrode of the electrode handle is brought into contact with the surgical instrument for activation (recommendation: first bring the active electrode into contact with the surgical instrument, only then start HF activation).
  • Page 81 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Technical Data Power setting range: 1–150 W at 400 Ω Max. periodic HF output voltage: 1,200 V at maximum effect 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...
  • Page 82 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Forced Prep In comparison to the Forced Clamp current, the forced coagulation current Forced Prep effects coagulation more quickly. This makes this current suitable for preparation, since despite its dominant coagulation it has an effective cutting power.
  • Page 83 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Technical Data Output power setting range (sum of both outputs): 1–150 W at 500 Ω Max. periodic HF output voltage: 2,500 V at maximum effect setting Fundamental frequency: 404 kHz Crest factor: 3.4–7.5...
  • Page 84 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Contact Coag The “gentle” Contact Coag coagulation current is preferably applied via ball or paddle electrodes for hemostasis. The current penetrates deep into the tissue, resulting in volume coagulation. The user himself determines the degree of coagulation by the duration of the activation.
  • Page 85 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Technical Data Power setting range: 1–200 W at 250 Ω Max. periodic HF output voltage: 650 V Fundamental frequency: 382 kHz Crest factor: 2.6–3.2 Output curves Output power versus set power Repetitive peak output voltage versus set effect Setting Effect...
  • Page 86 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Forced Coag In comparison to the Contact Coag current, the forced coagulation current Forced Coag effects coagulation more quickly. The application technique is the same as for the Contact Coag current. If the instrument or electrode is only slightly in contact with the tissue, by design some sparking between the tissue and the electrode will be observed.
  • Page 87 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Technical Data Power setting range: 1–150 W at 600 Ω Max. periodic HF output voltage: 2,400 V Fundamental frequency: 412 kHz Crest factor: 4.4–5.0 Output curves Output power versus set power Repetitive peak output voltage versus set effect Setting Effect...
  • Page 88 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Uro Coag Uro Coag is a specialized coagulation current for use under liquids in combination with resectoscope loops. Similar to surface coagulation (see section 4.2.2 “Monopolar coagulation”, page 14), here the HF energy is directed into the tissue without or only with slight tissue contact.
  • Page 89 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Technical Data Power setting range: 1–150 W at 600 Ω Max. periodic HF output voltage: 2,500 V at maximum effect 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...
  • Page 90 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Spray Spray is a high-voltage coagulation current for non-contact surface coagulation with very low depth and carbonization. The current is expediently used for hemostasis in thoracic surgery (hemostasis on the sternum) or parenchyma tissue surgery.
  • Page 91 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Technical Data Power setting range: 1–80 W at 700 Ω Max. periodic HF output voltage: 4,500 V Fundamental frequency: 500 kHz Crest factor: 4.2–7.4 Output curves Output power versus set power Repetitive peak output voltage versus set effect Setting Effect...
  • Page 92 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Duo Prep If two monopolar patient circuits can be activated simultaneously via independent hand or foot switches, the selected power of the generator feeding the circuits can be split between the two channels. The corresponding technical standard (IEC 60601-2-2) provides this possibility only for coagulation currents allowing contact-free application.
  • Page 93 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Technical Data Output power setting range (sum of both outputs): 1–150 W at 500 Ω Max. periodic HF output voltage: 2,500 V at maximum effect setting Fundamental frequency: 404 kHz Crest factor: 3.4–7.5...
  • Page 94 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Duo Spray If two monopolar patient circuits can be activated simultaneously via independent hand or foot switches, the selected power of the generator feeding the circuits can be split between the two channels. The corresponding technical standard (IEC 60601-2-2) provides this possibility only for coagulation currents allowing contact-free application.
  • Page 95 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Technical Data Output power setting range (sum of both outputs): 1–80 W at 700 Ω Max. periodic HF output voltage: 4,500 V Fundamental frequency: 500 kHz Crest factor: 4.2–7.4 Output curves Output power versus set power...
  • Page 96 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Argon Beam Argon Beam is a current for surface coagulation by ionized argon gas for use in open surgery. For use of this current, a maxium® smart Beam and an MABS applicator are required. If this current is selected and a maxium®...
  • Page 97 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Technical Data Power setting range: 1–80 W at 700 Ω Max. periodic HF output voltage: 4,500 V Fundamental frequency: 500 kHz Crest factor: 4.2–7.4 Output curves Output power versus set power Repetitive peak output voltage versus set effect Setting Effect...

  • Page 98: Bipolar Cutting Currents

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam 11.3 Bipolar Cutting Currents Bipol Pure Cut The Bipol Pure Cut current offers the safety benefits of bipolar technology for tissue dissection as well. No stray currents, no leakage currents and no need for a neutral electrode – these are the prime benefits. Bipol Pure Cut provides a smooth cut with a low degree of eschar formation and low hemostasis effect.
  • Page 99 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Technical Data Power setting range: 1–120 W at 300 Ω Max. periodic HF output voltage: 390 V Fundamental frequency: 404 kHz Crest factor: Output curves Output power versus set power Repetitive peak output voltage versus set effect Setting Effect...
  • Page 100 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Forfex The Forfex bipolar cutting current supports mechanical cutting using scissors. The tissue between the two blades is coagulated by the Forfex current during cutting. Forfex is specifically designed for bipolar scissors, i.e.
  • Page 101 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Technical Data Power setting range: 1–120 W at 50 Ω Max. periodic HF output voltage: 240 V Fundamental frequency: 457 kHz Crest factor: Output curves Output power versus set power Repetitive peak output voltage versus set effect Setting Effect...

  • Page 102: Bipolar Coagulation Currents

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam 11.4 Bipolar Coagulation Currents BiCoag BiCoag is a current for open surgery and laparoscopy with bipolar forceps. BiCoag can be selected using a foot switch, automatic start or automatic start with time delay; for further information, refer to section 9.7 “Automatic Functions of Bipolar Coagulation”, page 51.
  • Page 103 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Technical Data Power setting range: 1–120 W at 50 Ω Max. periodic HF output voltage: 240 V Fundamental frequency: 457 kHz Crest factor: Output curves Output power versus set power Repetitive peak output voltage versus set effect Setting Effect...
  • Page 104 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Neptun Neptun is a bipolar current type for fluid-assisted coagulation (EHT method = electrohydrothermosation) Preferentially, isotonic saline solution is fed to the instrument tip through the flushing channel(s) of a bipolar instrument and dropwise applied to the tissue to be coagulated.
  • Page 105 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Technical Data Power setting range: 1–250 W at 50 Ω Max. periodic HF output voltage: 245 V Fundamental frequency: 457 kHz Crest factor: Output curves Output power versus set power Repetitive peak output voltage versus set effect Setting Effect...

  • Page 106: Cleaning And Disinfection

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Cleaning and Disinfection The responsibility for cleaning and disinfection lies with the operator/user of the product. Be sure to observe your local cleaning and hygiene regulations! The manufacturer recommends wiping disinfection according to the instructions of the manufacturer of the disinfection agent.

  • Page 107: Messages Of The Unit

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Messages of the Unit The bottom line of the screen text is used to display texts indicating operating or error conditions. Below, the messages are explained which help the user to determine the current status of the unit or perform to troubleshooting.
  • Page 108 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Message Description Unplug bipolar instrument from B during The unit expects that during the self-test there is no tissue contact. self-test! If during the self-test tissue contact is established with the instrument connected on B1, which may already be positioned on or in the patient, the unit will notice this.

  • Page 109: Messages In Case Of Activation Errors

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam 13.2 Messages in Case of Activation Errors If upon actuation of a foot switch, a finger switch on the instrument or, in case of a bipolar coagulation current with automatic activation upon tissue contact, no activation of the HF current takes place and instead one of the messages listed below appears, then carry out the measures described.

  • Page 110: Input Feedback

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam 13.3 Input Feedback The maxium® smart C will not accept illegal input or settings. A message will appear. In order to resolve the conflict, proceed as described in the table. Message Description This current is not available due to selection...

  • Page 111: Messages In Connection With Programs

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam 13.4 Messages in Connection with Programs The maxium® smart C will not accept illegal input or settings. A message will appear. In order to resolve the conflict, proceed as described in the table. Message Description The base program cannot be overwritten!

  • Page 112: Messages From The Argon Beamer And The Fume Suction System

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam 13.5 Messages from the Argon Beamer and the Fume Suction System The maxium® smart Beam and the maxium® smart Vac fume suction system can display malfunctions and status messages on the screen of the maxium® smart C. Message Description Argon Beamer warning: Underdosage...

  • Page 113: System Errors

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam 13.6 System Errors Below, a number of messages are listed which the user can take care of on his own if necessary. Message Description The HF generator is overheated from high power output over a longer period and needs a few minutes to cool down.

  • Page 114: Periodic Safety Checks (Sc)

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Periodic Safety Checks (SC) At least every 24 months the system (maxium® smart C with maxium® smart Beam) must be subjected to the following controls to be performed by people who, by virtue of their training, knowledge and expe- rience gained from practical activities are able to properly perform such safety checks and not obliged to adhere to instructions with regard to such control activities.
  • Page 115 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam HF current must be activatable. The activation lights assigned to the outputs M must be lit in the color of the activated current – yellow or blue –, and the activation sound must be audible. –...
  • Page 116 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam B. Measurement of the output data • Measure the HF output power for some exemplary currents. C. Safety measurements according to IEC 60601-1 These measurements are often carried out using an automated safety tester. During the automatic test sequence, the supply voltage is turned on and off again several times.
  • Page 117 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Patient leakage current • Normal condition Measurement of the current from the instrument connections M, B and NE to the ground in non- activated condition. To this purpose, multiple ports can be connected in parallel. However, if this leads to indication of a value that exceeds the upper limit of 10 µA according to IEC 60601-1, the connections must be measured individually, and the highest value is to be logged.

  • Page 118: Disposal

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Disposal 15.1 Packaging Gebrüder Martin will, as a matter of course, take back the full packaging if so desired, to recycle as many parts of the packaging as possible. If you do not wish to make use of this offer, you can dispose of the packaging with the normal paper or domestic garbage.

  • Page 119: Guidelines And Manufacturer's Declaration On Electromagnetic Compatibility (Emc)

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Guidelines and Manufacturer’s Declaration on Electromagnetic Compatibility (EMC) Guidance and manufacturer’s declaration – Electromagnetic interference emission The device maxium® smart C with or without maxium® smart Beam is designed for use in an electromagnetic environment as specified below.
  • Page 120 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Guidance and manufacturer’s declaration – Electromagnetic immunity The device is designed for use in the electromagnetic environment specified below. The user of the device must ensure that it is operated in such an environment. Electromagnetic environment –...
  • Page 121 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Guidance and manufacturer’s declaration – Electromagnetic immunity The device is designed for use in the electromagnetic environment specified below. The user of the device must ensure that it is operated in such an environment. IEC 60601 test Immunity test Compliance level...
  • Page 122 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Recommended separation distances between portable and mobile RF telecommunications equipment and the Gebrüder Martin maxium® smart C with or without maxium® smart Beam The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF telecommunications equipment (transmitters) and the device as recommended below, depending on the maximum output power of the communications equipment.

  • Page 123: Technical Specification

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Technical Specification 17.1 Technical Specifications of the maxium® The maxium® smart C is a microprocessor-controlled electrosurgery unit for interdisciplinary use. The maxium® smart C conforms to the latest state of the art and offers a high degree of safety. The maxium®...

  • Page 124: Technical Data For Maxium® Smart C

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam 17.2 Technical Data for maxium® smart C Description maxium® smart C Mains connection 100–240 V ± 10%; 50/60 Hz Mains power max. 6.3 A Mains fuse 6.3 A without HF output 45 VA Power consumption...
  • Page 125 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam When the neutral electrode for babies is selected, only the following monopolar currents and maximum powers are permitted: Monopolar cutting currents Monopolar coagulation currents Pure Cut up to 30 W Forced Clamp up to 30 W Blend Cut up to 30 W Forced Prep up to 30 W...

  • Page 126: Technical Data For Maxium® Smart Beam

    Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam 17.3 Technical Data for maxium® smart Beam Description maxium® smart Beam Power supply via the maxium® smart C Argon supply Only approved for MABS pressure reducer. Fuse M1.6A, internal Power consumption max.
  • Page 127 Instructions for Use maxium® smart C Electrosurgery Unit with maxium® smart Beam Revision 1...
  • Page 128 Gebrüder Martin GmbH & Co. KG A company of the KLS Martin Group KLS Martin Platz 1 · 78532 Tuttlingen · Germany Postfach 60 · 78501 Tuttlingen · Germany Tel. +49 7461 706-0 · Fax +49 7461 706-193 info@klsmartin.com · www.klsmartin.com Back Cover Date of Release: 2017-10 ·...

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