Hologic CYNOSURE ELLMAN SURGITRON 4.0 Dual RF/90 IEC Instruction Manual
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Hologic CYNOSURE ELLMAN SURGITRON 4.0 Dual RF/90 IEC Instruction Manual

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4.0 Dual RF
/90 IEC
Instruction Manual
(English-English)

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Summary of Contents for Hologic CYNOSURE ELLMAN SURGITRON 4.0 Dual RF/90 IEC

  • Page 1 ™ 4.0 Dual RF /90 IEC Instruction Manual (English-English)
  • Page 2 NEW PRODUCT WARRANTY New products manufactured by Cynosure, are warranted against any defects in material or workmanship for a period of one (1) year following the date of shipment to the Buyer. Cynosure, at its option, will repair or replace the same without charge, provided Buyer ships the product to Cynosure, transportation charges prepaid.

  • Page 3: Table Of Contents

    CONTENTS INTRODUCTION Page 2 ® Introduction to Radiosurgery Intended Use SAFETY Page 2 Warnings Precautions III. TECHNICAL INFORMATION Page 5 Packing List Supplier’s Information Cleaning, Disinfecting and Sterilizing the Unit and Accessories DESCRIPTION OF CONTROL ELEMENTS Page 6 Interface Accessories Rear Panel Control Elements Front Panel Control Elements Symbol definitions...
  • Page 4 CONTENTS VIII. TECHNICAL SPECIFICATIONS Page 21 Output Characteristics Preventive Inspection and Maintenance Safety Features Input Characteristics Size and Weight Operating Conditions Transportation & Storage Conditions Error Codes Table ELECTROMAGNETIC COMPATIBILITY Page 24 9.0 Warning 9.1 Precautions...

  • Page 5: Introduction

    I. INTRODUCTION ® INTRODUCTION TO RADIOSURGERY with Ellman’s Surgitron 4.0 Dual RF™/90 IEC system (Surgitron ® ® ® Radiosurgery Dual/EMC) is an excellent method of cutting and coagulating soft tissue. With five waveforms (4 monopolar and 1 bipolar) and a wide selection of electrode tips, the user can easily configure the system for a wide array of applications.

  • Page 6: Precautions

    PRECAUTIONS 2.1.1 General 2.1.1.1 Electrical shock hazard. Do not remove cover. Refer to authorized personnel for service. ® 2.1.1.2 Surgitron Dual/EMC may present a hazard to patients with pacemakers. Consult qualified medical personnel. 2.1.1.3 The manufacturer-supplied accessories should be used to ensure the proper operation of safety monitoring circuit.
  • Page 7 2.1.2 Neutral Plate NOTE: See Neutral Plate Instructions for Use for detailed device and use information. 2.1.2.1 The use and proper placement of the neutral plate is essential to the safe and effective use of this device in order to prevent burns from the neutral plate.

  • Page 8: Technical Information

    III. TECHNICAL INFORMATION PACKING LIST ® 3.0.1 Surgitron Dual/90 IEC (IEC3A-S30-90/110 or IEC3A-S30-90/220) 3.0.2 IEC Power cord 12ft (IEC-PC110, IEC-PCEU, IEC-PCUK, or IEC-PCANZ) 3.0.3 Instruction Manual (DIM-50-65) ACCESSORIES (See Catalog) 3.0.4 Disposable Neutral Plates 9.5 ft (IEC-NPD) 3.0.5 Dual Footswitch & Cable 12 ft (DF-FSC#) 3.0.6 Cart (H156 or H157) 3.0.7...

  • Page 9: Description Of Control Elements

    IV. DESCRIPTION OF CONTROL ELEMENTS INTERFACE ACCESORIES 4.0.1 Two Pedal Footswitch A heavy duty waterproof dual footswitch for CUT and COAG modes is supplied. The mode selectors described in 4.2 determine the cut and coag modes activated by the respective footswitch. The footswitch indicators described in 4.2, and will indicated the activated mode.

  • Page 10: Rear Panel Control Elements

    REAR PANEL CONTROL ELEMENTS Figure 4.1 Rear Panel Power Cord: The Surgitron ® Dual/EMC unit is shipped with a hospital grade power cord. WARNING: To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. ®...
  • Page 11 4.1.1 Line Fuse Replacement: Using a flat screwdriver, pry open the top of the line fuse door. Remove two fuse holders. Replace fuses with the same value/size fuses ONLY. The fuse holder arrows should be pointing towards the right. Snap the compartment back with the fuses inside. See Figure 4.1.1 below.

  • Page 12: Front Panel Control Elements

    FRONT PANEL CONTROL ELEMENTS Figure 4.2 Front Panel FINGERSWITCH HANDPIECE NEUTRAL BIPOLAR PLATE HANDPIECE Power Switch: When the power switch is turned on, the unit automatically performs the following functions: • The audio signal is sounded. • All start up sequences of tones on the front panel are activated during the functional test.
  • Page 13 Units are shipped from the factory with default power levels of 0 and modes of Cut and Hemo. To modify default values, simultaneously press and hold the Cutting Mode and Coagulation Mode Select buttons while turning on the unit. When CLR is displayed release the buttons and select the desired settings. Turn off power.

  • Page 14: Symbol Definitions

    Coagulation Mode Function Select Button: It is for selecting Coag, Fulgurate, or Bipolar function. Blue Light (Coag) Indicator: The indicator illuminates when Coag function has been selected. Blue Light (Fulgurate) Indicator: The indicator illuminates when Fulgurate function has been selected. Blue Light (Bipolar) Indicator: The indicator illuminates when Bipolar function has been selected.

  • Page 15: Preparation For Use

    4.3.8 Non-Ionization radiation 4.3.9 Equipotential Symbol 4.3.10 Refer to instruction manual/booklet 4.3.11 Keep dry 4.3.12 Serial Number Label with Fuse and Supply Ratings V. PREPARATION FOR USE PREPARATION FOR USE ® 5.0.1 On the Surgitron Dual/EMC check to make sure that the power switch is in the OFF position.

  • Page 16: Smoke Hazard

    The Fully Filtered Waveform is a pure continuous flow of high-frequency radiowaves. This filtration results in a continuous non-pulsating flow of radiowaves which provides a micro-smooth cutting flow. This wave produces the least amount of lateral heat and tissue destruction. 5.1.2 BLEND - For cutting with coagulation: Select BLEND by pushing SELECT button on the Cutting Mode to turn on the...

  • Page 17: Surgical Description And Use

    VI. SURGICAL DESCRIPTION AND USE ® LEARNING TO USE RADIOSURGERY Before making contact with the tissue, the power intensity must be selected and the foot pedal or fingerswitch must be activated. During the actual cutting, it is important to use a smooth uninterrupted motion with even and light manually applied pressure.

  • Page 18: Pre-Operative Cutting Practice

    PRE-OPERATIVE CUTTING PRACTICE Since Radiosurgery ® requires very little manually applied pressure to effect a cutting action, the user may gain control by supporting his/her hand in some fashion. Gentle touch, digital dexterity, a fluid wrist action, and a feather-light touch aid in ®...
  • Page 19 electrode. Place the meat on a Neutral Plate. Insert a ball electrode into the Handpiece. Select COAG. Set the output power intensity to 10. Position the ball electrode in light contact with the beef. Depress the COAG Footswitch pedal or the Fingerswitch HEMO button.

  • Page 20: Power Output Characteristics

    VII. POWER OUTPUT CHARACTERISTICS ® Surgitron Dual/EMC MONOPOLAR AND BIOPOLAR MODES Figure 7.0 Typical Nominal Plot Power Output vs Digital Setting Monopolar:500 Ohm Load; Bipolar 200 Ohm Load Cut/Coag Hemo Fulgurate Bipolar DIGITAL SETTING ® Surgitron Dual/EMC CUT MODE Figure 7.1 Typical Nominal Plot CUT MODE Power Output vs Resistive Load Half Setting –...

  • Page 21: Blend Mode Power Output Vs Resistive Load

    ® Surgitron Dual/EMC BLEND MODE Figure 7.2 Typical Nominal Plot BLEND MODE Power Output vs Resistive Load Half Setting – 50 Full Setting - 100 RESISTIVE LOAD (OHMS) ® Surgitron Dual/EMC COAG MODE Figure 7.3 Typical Nominal Plot COAG MODE Power Output vs Resistive Load Half Setting –...

  • Page 22: Fulgurate Mode Power Output Vs Resistive Load

    ®u Surgitron Dual/EMC FULGURATE MODE Figure 7.4 Typical Nominal Plot FULGURATE MODE Power Output vs Resistive Load Half Setting – 50 Full Setting - 100 RESISTIVE LOAD (OHMS) ® Surgitron Dual/EMC BIPOLAR MODE Figure 7.5 Typical Nominal Plot BIPOLAR MODE Power Output vs Resistive Load Half Setting –...
  • Page 23 ® Surgitron Dual/EMC MONOPOLAR/BIPOLAR MODES Figure 7.6 Typical Nominal Plot Voltage Output vs Digital Setting Open Circuit (No Load) CUT/COAG HEMO FULG BIPOLAR DIGITAL SETTING...

  • Page 24: Technical Specifications

    VIII. TECHNICAL SPECIFICATIONS OUTPUT CHARACTERISTICS Mode/ Output Maximum Power Output Power Output vs. Activation Character Waveform Output vs. Setting Load Resistance Power 4.0 MHz See Figure 7.0 See Figure 7.1 via footswitch or @ 500 Ω sinusoid fingerswitch Blend 4.0 MHz with See Figure 7.0 See Figure 7.2 via footswitch or...

  • Page 25: Safety Features

    SAFETY FEATURES 8.2.1 Standard Compliance IEC60601-1 IEC60601-1-2 IEC60601-2-2 UL 2601 (USA Version) CSA 22.2601 8.2.2 Electrical Safety Electric Shock: Class I Defibrillator Protection: Type BF 8.2.3 Neutral Plate earthed at HF 8.2.4 Neutral Plate monitor MAX 1000 ohms resistance between the 2 contact areas of a split neutral electrode 8.2.5 Alarm when resistance between...

  • Page 26: Transportation & Storage Conditions

    TRANSPORTATION & STORAGE CONDITIONS 8.6.1 Ambient Temperature: -10° C - +50° C 8.6.2 Relative Humidity: 10% - 95% 8.6.3 Atmospheric Pressure: 500 hPa -1060 hPa ERROR CODES TABLE DESCRIPTION ERROR CODE Interface to displays failed Interface to LEDS failed Interface to keypad failed Processor had a warm reset A/D converter error Foot/Fingerswitch interface failed...

  • Page 27: Electromagnetic Compatibility

    IX. ELECTROMAGNETIC COMPATIBILITY The information contained in this section (such as separation distances) is in general specifically written with regard to this model. The numbers provided will not guarantee faultless operation but should provide reasonable assurance of such. This information may not be applicable to other medical electrical equipment;...
  • Page 28 Electromagnetic Emissions This equipment is intended for use in the electromagnetic environment specified below. The user of this equipment should assure that is used in such an environment. Emissions Compliance Electromagnetic environment according to The Surgitron Dual/EMC must emit electromagnetic energy RF emissions (CISPR 11) Group 2 ®...
  • Page 29 This equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the equipment should assure that it is used in such an environment. Electromagnetic environment — guidance Immunity test IEC 60601 test level Compliance level Portable and mobile RF...
  • Page 30 Guidance and Manufacturer’s Declaration— Electromagnetic Immunity to Proximity Fields from RF Wireless Communication Equipment The equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the equipment should assure that it is used in such an environment. Immunity Service IEC60601...
  • Page 31 Recommended separation distances between portable and mobile RF communications equipment and the equipment Separation distance according to frequency of transmitters in meters Rated maximum 150 kHz — 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz output power d=1.2√P d=2.3√P of transmitter...
  • Page 32 Hologic BVBA Da Vincilaan 5 1930 Zaventem Belgium Tel: +32 2 711 46 80 Cynosure, LLC, 5 Carlisle Road, Westford MA, USA Tel: 888.523.2233 / Fax: 978.349.6152 DIM-50-65, Rev. 002 04/2019...

This manual is also suitable for:

Iec3a-s30-90/110Iec3a-s30-90/220

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