Söring MBC-601 User Manual
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Söring MBC-601 User Manual

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USERS MANUAL
S icherheit
MONO
MONO
MONO
BIPO
BIPO
Safety
CUT
COAG2
Cut
Coag
COAG1
5
5
5
4
4
4
3
3
3
2
2
2
1
1
1
F
MB C 6 0 1
Söring
1
2
Sicherheit
MONO
MONO
BIPO
Safety
COAG
COAG
CUT
5
5
4
4
3
3
2
2
1
1
F
MB C 6 0 0
Sör in g

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Summary of Contents for Söring MBC-601

  • Page 1 USERS MANUAL S icherheit MONO MONO MONO BIPO BIPO Safety COAG2 Coag COAG1 MB C 6 0 1 Söring Sicherheit MONO MONO BIPO Safety COAG COAG MB C 6 0 0 Sör in g...
  • Page 2 Söring 27/04/04 © Users manual RF-units Söring Inc Söring GmbH Medizintechnik 5009 Martin Luther King Jr. Freeway, Justus von Liebig Ring 10 Fort Worth, 25451 Quickborn TX 76119 Tel: 001-817-457-2200 Tel: (+) 49 (0)4106-6100-0 Fax: 001-817-547-2201 Fax: (+) 49 (0)4106-6100-10 E-mail: soring-usa@soering.com E-mail:...

  • Page 3: Table Of Contents

    Söring 27/04/04 © Users manual RF-units Contents 1. Introduction ......................... 5 2. Important notes regarding the operation of RF Surgery units ......6 2.1. Operating of RF Surgery Equipment ....................6 2.2. User instructions ...........................6 2.3. Prescribed safety checks ........................6 2.4. Medical Product Log Book ........................6 2.5.How to keep the instruction manual and the medical product log book .........7 2.6.
  • Page 4 Söring 27/04/04 © Users manual RF-units 9.1 Intervals..............................35 9.2 Extent ...............................35 9.3. Description of special checks ......................35 9.3.1. Check of controls and indicators .....................35 9.3.2. Check of handpieces and footswitches ..................35 9.3.3. Check of RF generators and safety devices ..................36 9.3.4.

  • Page 5: Introduction

    Söring 27/04/04 © Users manual RF-units 1. Introduction This operating manual describes the function and handling of the Radio Frequency Surgery Equipment MBC. The manual serves as an instruction reference and should be read thoroughly before operating the equipment. Only then can the correct handling of the equipment be assured. In case of incorrect handling no liability will be taken on by the manufacturer.

  • Page 6: Important Notes Regarding The Operation Of Rf Surgery Units

    Söring 27/04/04 © Users manual RF-units 2. Important notes regarding the operation of RF Surgery units During operation of RF surgery equipment disturbances of other electronic devices may occur due to generated interfering signals. 2.1. Operating of RF Surgery Equipment The user is only allowed to operate such RF Surgery Equipment after the manufacturer or the distributor has: 1.

  • Page 7: How To Keep The Instruction Manual And The Medical Product Log Book

    Söring 27/04/04 © Users manual RF-units 2.5.How to keep the instruction manual and the medical product log book Instruction manuals and equipment books for RF surgery equipment must be kept, so that they are always accessible to persons commissioned to use the equipment. The responsible authority may ask to look at these books at any time.

  • Page 8: Physiological And Physical Fundamentals Of Rf Surgery

    Söring 27/04/04 © Users manual RF-units 3. Physiological and physical fundamentals of RF Surgery Thermocautery as an aid to mechanical operation techniques began many years ago with the application of heated metal tools to wounds to control bleeding. The technique was found to be very effective.

  • Page 9: Reaction Of Biological Tissue To Local Overheating

    Söring 27/04/04 © Users manual RF-units HF-Generator RF-generator Aktive-Elektrode active electrode biologisches Gewebe biological tissue Neutral-Elektrode Patient electrode Fig 3.1. Shows the principle of RF Surgery 3.1.1 Reaction of biological tissue to local overheating If RF voltage (continuous sine signal) reaches a certain upper limit, an arc will occur at the contact zone of the active electrode to the tissue.
  • Page 10 Söring 27/04/04 © Users manual RF-units active electrode horny layer papilliary body subcutaneous fatty tissue musculature with connective tissue vessel bone Fig 3.2 Schematic representation of a melt-cut: Depending on the value of resistance of the different effected tissue the coagulation seam (the heat damage) is more or less widespread;...
  • Page 11 Söring 27/04/04 © Users manual RF-units active electrode coagulated tissue Fig. 3.3 Schematic representation of electro-coagulation on a homogenous tissue: The boiling extends to a depth somewhat larger than the diameter of the electrode. It is strongest underneath the electrode. At the surface it also extends to the surroundings of the electrode (rim effect). generated eschar active electrode coagulated tissue...

  • Page 12: Methods Of Rf Surgery And Electrical Signal Shapes

    Söring 27/04/04 © Users manual RF-units 3.2 Methods of RF Surgery and electrical Signal Shapes Cutting and coagulation modes of RF surgery depend in part on the shape of the sine wave of the electrical current. The frequency is remains around the 350 kHz range but the current amplitude (power) is changed to meet the surgical demands.

  • Page 13: Coagulation

    Söring 27/04/04 © Users manual RF-units smooth Cut, rich of Cut with eschar coagulation Fig. 3.6 The smooth cut is largely comparable to the cut with a conventional scalpel, i.e. the cutting surfaces are only slightly colored. This cutting mode is achieved with unmodulated RF-current and by carrying-out the cut quickly.

  • Page 14: Bipolar Application Technique

    Söring 27/04/04 © Users manual RF-units generated and no direct contact is necessary. The spark over causes an extreme temperature rise in the tissue areas close to the surface and destroys them (surface coagulation, eschar, carbonization). Electrodes with a small area like small ball or needle electrodes are used. The necessary high voltage with moderate RF power is reached by high pulse modulation.

  • Page 15: Patient Safety

    Söring 27/04/04 © Users manual RF-units 4. Patient safety The power output should be reduced to a value as small as possible in order to obtain maximum patient safety with the application. Apparent low output of the RF surgical equipment to function correctly at the normal operating settings may indicate faulty application of the patient electrode and its contact in its connections.
  • Page 16 Söring 27/04/04 © Users manual RF-units body, but under no circumstances at the thorax, because in this case the heart would be located in the direct current path. Fig. 4.1.Suggested placement of conventional patient electrodes and relevant operation fields. Permanent electrodes must be carefully secured with a flexible bandage or with elastic bands.
  • Page 17 Söring 27/04/04 © Users manual RF-units Fig 4.3 Moistening of body parts for fastening of patient electrode According to manufacturer’s specification the patient electrode must have a clean surface free of corrosion and oxides in order to keep the transfer resistance as small as possible.

  • Page 18: Current Carrying Cables

    Söring 27/04/04 © Users manual RF-units Strombegrenzungswiderstände current-limiting Resistors Aktivelektrode Active electrode EKG-unit ECG unit N-EKG N-ECG Aktivelektrode N-HF Active electrode N-RF Neutralelektrode Patient electrode Fig 4.6 EKG cables with current limiting resistors Needle electrodes are not recommended for EKG monitoring. Because of their small surface area the risk of burns is increased.

  • Page 19: Dangers From Inflammable And Explosive Media

    Söring 27/04/04 © Users manual RF-units 4.5. Dangers from inflammable and explosive media. In RF surgery development of sparks at the active electrodes cannot be avoided. If inflammable or explosive agents for e.g. anesthesia, skin cleaning, degreasing and disinfection or endogenous gases e.g. within the gastrointestinal tract are present, RF surgery must not be applied because of fire and explosion hazard.

  • Page 20: Arrangement Of Switches, Sockets And Displays Of Mbc 601

    Söring 27/04/04 © Users manual RF-units Arrangement of Switches, Sockets and displays of MBC 601 MBC 601 Söring not valid for MBC600 -20-...

  • Page 21: Arrangement Of Switches, Sockets And Displays Of Mbc 600

    Söring 27/04/04 © Users manual RF-units Arrangement of Switches, Sockets and displays of MBC 600 MBC 600 Söring not valid for MBC600 -21-...

  • Page 22: Description Of Controls And Indicators

    Söring 27/04/04 © Users manual RF-units 5. General description of the equipment The MBC RF surgery equipment makes different applications available. For monopolar applications in addition to the basic continuous power output three coagulation methods are available, i.e., Spray, Force, and Soft may be selectable. For cut functions it has to be distinguished between pure cutting and cutting with the functions Blend, TUR, Pulse and Pulse TUR.
  • Page 23 Söring 27/04/04 © Users manual RF-units Power switch Connection for patient electrode (See also chapter 4.2 and chapter 5.1.1) This RF equipment has patient electrode monitoring, which checks the correct attachment of the patient electrode to the patient. For this purpose the use of a split patient electrode is necessary.
  • Page 24 Söring 27/04/04 © Users manual RF-units Safety field (For detailed description see chapter 5.1.1) Patient Electrode failure: Indication for correct patient electrode connection Functional error: Shows malfunction of equipment during internal safe test. Error code is shown on 7- segment display CUT Dosage error: Indication that an equipment dependent output power error occurs.
  • Page 25 Söring 27/04/04 © Users manual RF-units Bipolar automatic button Pressing this button enables automatic mode In automatic mode a tissue contact by the forceps is automatically recognized and the HF generator is activated. A measurement of the resistance is carried out for coagulation. The generator will be turned off, if the tissue impedance is higher than 3,5kohm (good coagulation result), latestly after the maximum time of 5sec.
  • Page 26 Söring 27/04/04 © Users manual RF-units Connection for potential equalization Connection pins for potential equalization cable between RF equipment and potential equalization bar in OR room. The yellow-green potential equalization cable supplied by the manufacturer must be used. Connecting socket for double pedal footswitch This is the footswitch connector for operation of monopolar applications of Cutting and Coagulation as well as for operation of bipolar function.

  • Page 27: Description Of The Safety Equipment

    Söring 27/04/04 © Users manual RF-units - CUT1 button has to be pressed and held Press "PROG" button shortly and let off CUT 1 button -The CUT display shows now "ErA". By pressing one program button (1-10) the relevant program will be erased; the LED switched off -By pressing the "PROG"...

  • Page 28: Putting The Equipment Into Operation

    Söring 27/04/04 © Users manual RF-units 5.2 Putting the equipment into operation To become familiar with this equipment the user should carefully read this chapter. This is especially important when operating the equipment for the first time in order to avoid mis- operations! 5.2.1 Description of operational facilities The functions Cutting and Coagulation can be activated by the finger switch as well as by the...

  • Page 29: Adjustment Of Function Fields

    Söring 27/04/04 © Users manual RF-units Bipolar Cut Step Bipolar Coag Step Only after the self-test the instruments should be adapted. If the monopolar handpiece is connected and the patient electrode is not connected, the red patient electrode indicator blinks in the safety field.

  • Page 30: Accessories (Extracts)

    Söring 27/04/04 © Users manual RF-units 6. Accessories (extracts) Reusable patient electrode The reusable patient electrode consists of soft, flexible and conductive silicon material. The patient electrode can be connected via an additional cable to the RF surgery equipment. The reusable patient electrode is available an undivided version.

  • Page 31: Cleaning, Maintenance, Disinfection And Sterilization

    Söring 27/04/04 © Users manual RF-units 7. Cleaning, maintenance, disinfection and sterilization Equipment The equipment should only be treated with non-inflammable and non-explosive cleaning and disinfection agents. Care should be taken that no liquids soak into the equipment. ATTENTION: The following points are only valid for Söring products!!! Handpieces Handpieces as well as their cables and connectors should be treated with non-inflammable and non-explosive cleaning as well as disinfection agents.

  • Page 32: Technical Data

    Söring 27/04/04 © Users manual RF-units 8. Technical Data Mode Power output into Output range Nominal Output Volt. Ω Frequency [kHz] Ω Cut 1 10W [200 Ω Cut 2 130W 1160 70W [200 Ω Cut 3 210W 1240 130W [200 Ω...
  • Page 33 Söring 27/04/04 © Users manual RF-units Mode Power output into Output range Nominal Output Volt. Ω Frequency [kHz] Ω Force 1 5W [200 Ω Force 2 1150 30W [200 Ω Force 3 1300 55W [200 Ω Force 4 120W 1320 80W [200 Ω...
  • Page 34 Söring 27/04/04 © Users manual RF-units Error codes (Further data see service manual!!!) If occurring problems can not be solved by the service technician in the hospital please call the Söring Company at 682-531-0950and transmit the error code and the serial number of the unit! Basically the error code is indicated in the left most 7-segment display.

  • Page 35: Technical Safety Checks

    Söring 27/04/04 © Users manual RF-units 9. Technical safety checks 9.1 Intervals Safety checks must be carried out annually. 9.2 Extent -Check for presence of medical product log book and instruction manual. -Check for electrical safety Ω -Check of protective conductor (<0.3 -Check of equipment current leakage (<...
  • Page 36 Söring 27/04/04 © Users manual RF-units 9.3.3. Check of RF generators and safety devices Function test of RF generators, RF relays and leakage current detector. The following equipment is needed: -Measuring device for RF surgery equipment for measurement of output power and RF leakage current, e.g.
  • Page 37 Söring 27/04/04 © Users manual RF-units Remarks not valid for MBC600 -37-...
  • Page 38 Söring 27/04/04 © Users manual RF-units 03-092 not valid for MBC600 -38-...

This manual is also suitable for:

Mbc-600

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