KLS Martin Minicutter Instructions For Use Manual
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KLS Martin Minicutter Instructions For Use Manual

Electrosurgical unit
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Front Cover
English
90-251-52-41
Revision 08
Date of Release: 2021-02
Electrosurgical Unit Minicutter
Instructions for Use

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Summary of Contents for KLS Martin Minicutter

  • Page 1 Front Cover Electrosurgical Unit Minicutter English Instructions for Use 90-251-52-41 Revision 08 Date of Release: 2021-02...
  • Page 2 Quick Instructions for Use Minicutter For the assignment of the position numbers, see section 4.2 Functions of the Control Elements, Connections and Displays, page 11. After voltage check: Connection to mains Switching on Monopolar operation Bipolar operation Connect neutral electrode to socket (11)
  • Page 3 Explanation of Symbols Hazard symbol ATTENTION Warns of possible bodily injury WARNING Warns of danger to life DANGER Warns of acute danger to life Follow Instructions for Use Catalog number Serial number Manufacturer Manufacturing date Non-ionizing electromagnetic radiation CE conformity marking Warning: Dangerous high voltage! Class I equipment acc.

  • Page 4: Table Of Contents

    Instructions for Use Electrosurgical Unit Minicutter Contents Product Liability and Warranty ................6 General Information ......................6 Scope of Delivery ........................ 6 Intended Use ........................6 Warranty ..........................6 Inspection upon Receipt by User ..................7 Hotline ..........................7 Notes on this Document ..................8 Symbols Used in this Document ..................
  • Page 5 Instructions for Use Electrosurgical Unit Minicutter Gases in the Operation Area ..................... 27 Risks from Electromagnetic Interference ................. 28 Cable Routing on the Patient .................... 29 Putting Down HF Instruments ................... 29 General Safety Information ....................29 5.9.1 Combination with Other Devices ....................30 5.10...

  • Page 6: Product Liability And Warranty

    Product Liability and Warranty General Information We thank you for buying a KLS Martin product. This product carries the CE mark, which means that it satisfies the essential requirements laid down in the EC Directive concerning medical devices. We are the manufacturer of this product: Gebrüder Martin GmbH &...

  • Page 7: Inspection Upon Receipt By User

    Instructions for Use Electrosurgical Unit Minicutter Important Notices The product may only be repaired by Gebrüder Martin or a qualified person or firm expressly authorized by Gebrüder Martin to perform such work. 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 8: Notes On This Document

    Instructions for Use Electrosurgical Unit Minicutter Notes on this Document Non-observance of this document can lead to serious or even lethal patient injury! Improper handling and care as well as use other than intended can lead to premature wear and/or pose...

  • Page 9: Functional Principle

    Functional Principle Monopolar Functional Principle The electrosurgical unit Minicutter is a generator in which electrical energy from the mains supply is converted into high-frequency current. In monopolar application, the HF current is transmitted to the operation field via an active electrode in a handle or other surgical instrument. This leads to high energy concentration in a small area at the application site of the active electrode in the tissue surroundings of the point of contact, resulting in the desired electrosurgical effect.

  • Page 10: Commissioning

    Instructions for Use Electrosurgical Unit Minicutter Commissioning For the assignment of the numbering, see section 4.2 Functions of the Control Elements, Connections and Displays, page 6 Technical Specification The unit can be used universally and has excellent performance data. The unit meets the latest safety standards.

  • Page 11: Functions Of The Control Elements, Connections And Displays

    Instructions for Use Electrosurgical Unit Minicutter Functions of the Control Elements, Connections and Displays 1 Rotary knob for power setting 2 Activation LED for monopolar cutting 3 Selection button for monopolar cutting 1 4 Selection button for monopolar cutting 2...

  • Page 12: Mains Connection

    Instructions for Use Electrosurgical Unit Minicutter T1.6 AH, 250V 16 Mains fuses T1.6 AH, 250V 17 Connection for mains cable 18 Type plate 19 Equipotential bonding connection Connection for neutral electrode Neutral electrode for HF currents connected to ground; not connected for NF currents...

  • Page 13: Equipotential Bonding Connection

    Instructions for Use Electrosurgical Unit Minicutter Danger of electric shock! In order to avoid the risk of electric shock, this device may be connected only to a grounded mains supply. Connect the device to the power outlet using the mains cable. Set mains switch (10) on the front side of the unit to position “I”.

  • Page 14: Connection Of Handles

    Instructions for Use Electrosurgical Unit Minicutter If the neutral electrode is not connected, or in case of insufficient contact to the skin, the status indicator (12) for the neutral electrode flashes green. If you attempt to activate the device in this state using the finger or foot switch, an additional warning signal is sounded.

  • Page 15: Selection Of The Current Type

    Instructions for Use Electrosurgical Unit Minicutter 4.6.3 Selection of the Current Type The unit has two monopolar operating modes and one bipolar one: Monopolar Cut (monopolar cutting) • Monopolar Coag (monopolar coagulation) • Bipolar Coag (bipolar coagulation), see section 4.7.3 “Selecting the Bipolar Operating Mode”, page 19) •...

  • Page 16: Power Setting

    Instructions for Use Electrosurgical Unit Minicutter Risk of burns from high HF current concentration! The hazard potential of electrosurgery increases with the power applied. Therefore please note the following: The high-frequency power should be set to the lowest possible setting for the respective application.

  • Page 17: Functional Test

    Instructions for Use Electrosurgical Unit Minicutter Risk of electric shock! When inserting the electrode and while replacing an electrode, the high-frequency current must not be activated. Danger of burns from unintentional actuation of a finger switch! Unintentional actuation of a finger switch can cause uncontrolled HF activation. This can result in a thermal effect at an unintended body location, for example when a surgical instrument is connected.

  • Page 18: Bipolar Operation

    Instructions for Use Electrosurgical Unit Minicutter an intermittent acoustic warning signal is sounded instead of the continuous activation tone. The activation of HF current is blocked. When selected, bipolar currents can, however, be activated. • Re-insert the plug of the connection cable for the single-surface neutral electrode into the connection socket (11).

  • Page 19: Connecting Bipolar Instruments

    Instructions for Use Electrosurgical Unit Minicutter 4.7.2 Connecting Bipolar Instruments An instrument connection cable is connected to socket (14) for bipolar coagulation. A variety of instruments can be connected to this cable. The activation is triggered exclusively via the foot switch that must be connected to socket (15).

  • Page 20: Bipolar Operating Mode

    Instructions for Use Electrosurgical Unit Minicutter 4.7.5 Bipolar Operating Mode For bipolar operation, the current type bipolar coagulation must be activated! The current type bipolar coagulation is activated by pressing the foot switch. The bipolar HF current is provided in accordance with the selected power. At the same time, an acoustic signal can be heard, and the corresponding activation LED (8) lights up.
  • Page 21 Instructions for Use Electrosurgical Unit Minicutter Risk of malfunction and danger of injury from high current concentration! After prolonged application of HF current at high power, the surface of the device can heat up significantly. In case of HF activation for more than 15 s, an acoustic warning signal is sounded by increasing the volume of the activation sound.

  • Page 22: Safety Measures

    Instructions for Use Electrosurgical Unit Minicutter Safety Measures General Information Failure to comply with the following safety measures may result in serious or even lethal patient or user injury! The unit 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 23: Patient Placement

    Instructions for Use Electrosurgical Unit Minicutter Patient Placement Risk of burns from stray currents! Electrosurgical devices are high-frequency generators designed to create high voltages and currents. The risk of burns is particularly high where high-power monopolar cutting and contact coagulation currents are used, while it is very low in purely bipolar application.
  • Page 24 Instructions for Use Electrosurgical Unit Minicutter Danger of injury from damage to active implants! In patients with active implants such as pacemakers or implanted electrodes, the application of the electrosurgical unit poses a risk. Application may result in irreparable damage to the active implant or impairment of its function.

  • Page 25: Working With The Active Electrode

    Instructions for Use Electrosurgical Unit Minicutter Risk of burns from improper handling of the neutral electrode! The risk of burns under the neutral electrode is particularly high when monopolar cutting or contact coagulation currents with particularly high power and longer duration are being used...
  • Page 26 Instructions for Use Electrosurgical Unit Minicutter Danger of burns from defective active electrodes! Active electrodes with insulation defects pose danger of burns for patient and user. Therefore, please note: Active electrodes, their sockets and lines must be examined for defects of the insulation before being •...

  • Page 27: Gases In The Operation Area

    Instructions for Use Electrosurgical Unit Minicutter Gases in the Operation Area Danger of explosion and fire! Materials saturated with oxygen, such as cotton or gauze, may catch fire from the sparks that occur during the intended use of the electrosurgical device. Sparking on the active electrode will always occur when using electrosurgical devices.

  • Page 28: Risks From Electromagnetic Interference

    Instructions for Use Electrosurgical Unit Minicutter Risks from Electromagnetic Interference Danger from electromagnetic interference! Radios, cell phones, or other emitters in the immediate vicinity of the device may affect the safe operation of the same. For minimum distances from emitting devices, see section 11 “Guidelines and Manufacturer’s Declaration Regarding Electromagnetic Compatibility (EMC)”, page 45.

  • Page 29: Cable Routing On The Patient

    Instructions for Use Electrosurgical Unit Minicutter Cable Routing on the Patient The maximum length of the cable between the Minicutter and accessories is 5 m. Risk of burns from stray currents! HF current focused on small areas can result in burns.

  • Page 30: Combination With Other Devices

    The unit may be combined with other electro-medical units only by the manufacturer or with the manufacturer's consent. When combining the Minicutter with electromedical devices other than those specified in these Instructions for Use, attention must be paid to the following points: The electrosurgical unit may interfere with other electro-medical devices.

  • Page 31: Cleaning And Disinfection

    Instructions for Use Electrosurgical Unit Minicutter Cleaning and Disinfection The operator / user is responsible for cleaning and disinfecting the device. National regulations regarding cleaning and hygiene are to be complied with. Risk of serious injury from defective accessories! A non-functional unit or defective accessories can endanger the patient or user, as well as affect the intended functions of the unit.

  • Page 32: Safety Check (Sc)

    Instructions for Use Electrosurgical Unit Minicutter Safety Check (SC) At least every 24 months, the device must be subjected to the following controls to be performed by people who, by virtue of their training, knowledge and experience gained from practical activities are able to properly perform such safety checks and who are not obliged to adhere to instructions with regard to such control activities.

  • Page 33: Accessories

    Instructions for Use Electrosurgical Unit Minicutter Accessories The unit may be used only with accessories, wear parts and single-use articles whose safety of use has been demonstrated by a declaration of conformity. The accessory parts certified for electrosurgical units by Gebrüder Martin can be found in the Gebrüder Martin accessories catalog, which can be requested or downloaded directly from www.klsmartin.com.

  • Page 34: Technical Data

    Instructions for Use Electrosurgical Unit Minicutter Technical Data Designation Data electrosurgical unit Minicutter Mains connection 100–240 V; 50/60 Hz Power consumption without HF output approx. 16 VA at max. output power approx. 120 VA Protection class IP classification IP2X Classification acc. to German...

  • Page 35: Currents, Their Properties And Technical Data

    Instructions for Use Electrosurgical Unit Minicutter Currents, their Properties and Technical Data Cutting 1 (Pure) Clean cutting without eschar formation Power setting range: Max. 80 W at 300 Ω Max. periodic HF output voltage: max. 1,200 Vmax Max. output current 510 mA at 300 Ω...
  • Page 36 Instructions for Use Electrosurgical Unit Minicutter Maximum and one-half maximum output power Setting 10 Setting 5 Connection resistance in Ω Revision 08...
  • Page 37 Instructions for Use Electrosurgical Unit Minicutter Cutting 2 (Blend) Clean cutting without eschar formation Power setting range: max. 70 W at 300 Ω Max. periodic HF output voltage: Max. 1,500 V Max. output current 480 mA at 300 Ω Crest factor...
  • Page 38 Instructions for Use Electrosurgical Unit Minicutter Maximum and one-half maximum output power Setting 10 Setting 5 Connection resistance in Ω Revision 08...
  • Page 39 Instructions for Use Electrosurgical Unit Minicutter Contact coagulation Coagulation with high depth upon direct contact between electrode and tissue Power setting range: Max. 70 W at 200 Ω Max. periodic HF output voltage: Max. 1,300 V Max. output current 600 mA at 200 Ω...
  • Page 40 Instructions for Use Electrosurgical Unit Minicutter Maximum and one-half maximum output power Setting 10 Setting 5 Connection resistance in Ω Revision 08...
  • Page 41 Instructions for Use Electrosurgical Unit Minicutter Spray coagulation Coagulation current with high voltage for surface coagulation (fulguration). Power setting range: Max. 60 W at 300 Ω Max. periodic HF output voltage: Max. 2,000 V Max. output current 450 mA at 300 Ω...
  • Page 42 Instructions for Use Electrosurgical Unit Minicutter Maximum and one-half maximum output power Setting 10 Setting 5 Connection resistance in Ω Revision 08...
  • Page 43 Instructions for Use Electrosurgical Unit Minicutter Bipolar coagulation Coagulation current with high voltage for surface coagulation (fulguration). Power setting range: Max. 70 W at 50 Ω Max. periodic HF output voltage: Max. 340 V Max. output current 1.200 mA at 50 Ω...
  • Page 44 Instructions for Use Electrosurgical Unit Minicutter Maximum and one-half maximum output power Setting 10 Setting 5 Connection resistance in Ω Revision 08...

  • Page 45: Guidelines And Manufacturer's Declaration Regarding Electromagnetic Compatibility (Emc)

    In case of doubt, contact Gebrüder Martin. Guidance and manufacturer’s declaration – Electromagnetic emission The electrosurgical unit Minicutter is intended for use in an electromagnetic environment as specified below. The user must ensure that it is used in such an environment.
  • Page 46 Instructions for Use Electrosurgical Unit Minicutter Guidance and manufacturer’s declaration – Electromagnetic immunity The device is intended for use in an electromagnetic environment as specified below. The user of the device must ensure that it is used in such an environment.
  • Page 47 Instructions for Use Electrosurgical Unit Minicutter Guidance and manufacturer’s declaration – Electromagnetic immunity The device is intended for use in an electromagnetic environment as specified below. The user of the device must ensure that it is used in such an environment.
  • Page 48 – 217 Hz A minimum safety distance of 30 cm (12″) between portable HF communication equipment emitting in the respective frequency band and the Gebrüder Martin Minicutter Note should be observed. This includes e.g. cell phones and WIFI, RFID and Bluetooth devices.

  • Page 49: Ecological Information

    Instructions for Use Electrosurgical Unit Minicutter Ecological Information 12.1 Packaging Gebrüder Martin will take back the full packaging upon request. 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 as paper and household waste.
  • Page 50 Instructions for Use Electrosurgical Unit Minicutter Revision 08...
  • Page 51 Instructions for Use Electrosurgical Unit Minicutter Revision 08...
  • Page 52 Gebrüder Martin GmbH & Co. KG A company of the KLS Martin Group KLS Martin Platz 1 · D-78532 Tuttlingen · Germany P.O. Box 60 · D-78501 Tuttlingen · Germany Phone +49 7461 706-0 · Fax +49 7461 706-193 info@klsmartin.com ·...

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