STARmed VIVA combo RF System Manual
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STARmed VIVA combo RF System Manual

With coagulation electrode
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(Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro,
IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355
User's Guide
VIVA combo RF System
With
Coagulation Electrode
(ST-UM-15E(US) Rev.3)
1

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  • Page 1 (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 User’s Guide VIVA combo RF System With Coagulation Electrode (ST-UM-15E(US) Rev.3)
  • Page 2 No part of this document may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means-electronic, mechanical photocopying, recording, or otherwise-without written consent of STARmed Co., Ltd. Additional copies of this document can be provided if requested.

  • Page 3: Product Warranty

    (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 Product Warranty Warranty is for one year. The company will repair this product for free during the warranty period, one year from the date of purchase, when there is malfunction or product defect that may have been a result of normal transportation and use.

  • Page 4: Safety Warning

    (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 Safety Warning Danger Indication of the hazardous situation that could result in death, serious injury, or  permanent impairment. Warning Indication of the hazardous situation that could result in minor or moderate harm to a ...

  • Page 5: Table Of Contents

    (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 Table of Contents Product Warranty ..................................3 Safety Warning ..................................4 1. System Overview ................................7 Cautions for Electric Safety ........................ 8 Radiofrequency lesion generator ......................8 1.1. Peristaltic pump ..............................
  • Page 6 (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 RF OUT (General Mode) ..........................29 CONTINUANCE RF OUT(for Tract albaiton) ................30 TEMPERATURE MODE ..........................30 OHM/CHECK ..............................30 Operation and storage of PC linked monitor program ............31 (VIVALogger) ..............................

  • Page 7: System Overview

    (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 1. System Overview Caution Use this equipment only after reading warning, cautions and information on the product’s  usage. Use other accessories related to this equipment only after reading the warnings, ...

  • Page 8: Cautions For Electric Safety

    Read the user’s guide before operating the RF Lesion generator for tissue ablation during surgical procedures and the pump. Caution User should not disassemble the equipment. Inquire with the STARmed on how to prevent  electric shock.

  • Page 9: Peristaltic Pump

    Warning Stop the pump immediately and remove the power cord if the pump becomes wet.  User should not disassemble the equipment. Inquire with STARmed on how to prevent  electric shock. Do not use this pump at a place that is vulnerable to explosion and/or where there is ...

  • Page 10: Caution For General Safety

    This equipment is safe from the electric danger and it obtained the permit based on the Medical Equipment Law. VIVA combo RF System was certified as appropriate by the IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2. This is a Class 1 Type BF medical device.

  • Page 11: Grounding Pad

     effective use of this equipment, as well as to avoid grounding pad burns. Read the Instruction for Use (IFU) that is included with all electrodes from STARmed Co.,  Ltd for the correct grounding pad usage. The IFU includes the information on the preparation of the grounding pads, location for attachment, inspection, and removal.
  • Page 12 (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 defect. This means that the amount of current that flows at the electrode’s tip can decrease, and there is high possibility that burning may result in an unintended area. The measurement of the body’s temperature through the electrode may be inaccurate ...

  • Page 13: Surgical Treatment Cautions

    PC connection may get disconnected. If that happens, the PC linked program should be connected again. The electrode should only be used with STARmed Co., Ltd. products.  1.4. Intended Use The VIVA combo RF System is intended for use in percutaneous and intraoperative coagulation and ablation of tissue.

  • Page 14: Contraindications

    (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 1.5. Contraindications There is a risk that error may result due to the radiofrequency current on patients who have pacemakers and other active implants. Do not use the radiofrequency lesion generator and electrode on these patients.

  • Page 15: Intended User Profile

    (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 1.8. Intended USER PROFILE Considerations Requirement description Minimum Medical doctor who has medical license.  Education Maximum  Knowledge of the side effects or complications due to  Minimum the error of medical device.

  • Page 16: System Description

    (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 1.12. System description The VIVA combo RF system consists of an RF generator, Peristaltic pump, cables, and accessories. This VIVA combo RF Lesion generator is designed to coagulate local tissue through a coagulation electrode.

  • Page 17: Preparations Before Use

    (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 1.13. Preparations before Use Radiofrequency lesion generator 1. Check the rated voltage is correct for the equipment before connecting the power. Caution The equipment may be damaged if it is not connected to the correct voltage. ...

  • Page 18: Grounding Pads Inspection

    (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 Grounding pads inspection 1. When attaching the grounding pads to the patient’s thigh, please make the pads are firmly attached without air bubbles or irregularity. 2. There is a risk of burning when the grounding pads are not completely attached to the patient’s thigh.
  • Page 19 (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 [Location for the pump diagram] 5. Push the input tube’s spike into the inside of the saline solution bag while the input tube’s roller clamp is temporarily closed. 6.
  • Page 20 (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 [VP01-1] 1. Saline solution bag is located at a higher part, and maintain so that the air in the saline solution bag elevates upward. 2. Up the flip cover indicated in the following photo in a up direction. 3.
  • Page 21 (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 Warning star RF Electrode and tubing set are sterilized products for disposable use. Re-  sterilization and re-use are prohibited. Stop using the electrode if the patient’s body temperature is not indicated on the screen ...

  • Page 22: System Connection Diagram

    (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 1.14. System Connection Diagram Saline <0 ℃ in IV Bag for Electrode Cooling...

  • Page 23: Radiofrequency Lesion Generator

    (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 2. Radiofrequency Lesion Generator Caution Use the equipment only after reading the warnings, cautions, and information on the  product’s usage. Use other accessories related to this equipment only after reading the warnings, ...

  • Page 24: Description Of Generator's Front Panel

    (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 2.1. Description of generator’s front panel ④ ① ② ③ ⑪ ⑩ ⑤ ⑨ ⑧ ⑦ ⑥ Feature Name Function 1 OHM/RESET button Measures the impedance of targeted tissue from the active tip. Mode selected (General, Continuance, Auto, Temperature) 2 MODE button button...

  • Page 25: Description Of Generator's Rear Panel

    (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 2.2. Description of generator’s rear panel Feature Name Function 1 Ventilation hole Hole for cooling down the inside of the system Foot switch connector Foot switch pedal connected with this part that offers the same (upper part) function as that of the RF ON/OFF button function Connecting part for the serial communication with PC, and it...

  • Page 26: Description Of Generator's Side Panel

    (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 2.3. Description of generator’s side panel ① ② ③ Feature Name Function Temperature sensor Used to measure the temperature of the procedure part connector B Temperature sensor Used to measure the temperature of the procedure part connector A 3 Ventilation hole Hole for cooling down the inside of the system...

  • Page 27: Main Screen

    (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 2.4. Main screen Feature Name Function Indicates the resistance value of the targeted tissue at the time 1 IMPEDANCE of RF output. Indicates the actual amount of radiofrequency power that is 2 RF POWER-LAP supplied to the electrode and targeted tissue.
  • Page 28 (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 Indicates message when the resistance value is too high or when the System message 1 state of grounding pads, electrode connection are faulty System message Indicates message when RF output is 0 (General Mode only). System message Indicates message when the temperature is too high.

  • Page 29: Usage

    (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 2.5. Usage 50W RF OUT (AUTO Mode) A) The initial values are set with 50W, 12 minute-long automatically when press the AUTO Mode button on the generator’s front panel. AUTO button lights up with blue color. The initial value can be set up the desired output value with the RF POWER control dial.

  • Page 30: Continuance Rf Out(For Tract Albaiton)

    (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 CONTINUANCE RF OUT A) Set the desired output with the RF power control dial after pressing on the CONTINUANCE Mode button. Output changes in units of 5W and appears on the Segment, VFD indication screen.

  • Page 31: Operation And Storage Of Pc Linked Monitor Program

    (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 Operation and storage of PC linked monitor program Feature name Function Connect or Disconnect a USB Serial Start monitoring communication between your PC and RF Generator. To set a folder which the log files will be saved Path To set a id Indicates the status of the monitoring of the...
  • Page 32 (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 2) Execute by double clicking the ‘MRFALogger’ shortcut icon or the MRFALogger.exe in the folder of the path where software is installed. 3) Select the computer with the searcher concerning the communication port setting (sequence: Diagram 1 →...
  • Page 33 (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 Diagram 2 Diagram 3 Caution Depending on your PC, USB communication could be disconnected. In that case, set the  USB communication port again. 4) USB Serial Port Select and execute the port menu to set up the communication port that is currently in use.
  • Page 34 (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 If the message shows ‘No Port’, ‘Select a port’ dialog is displayed automatically to set USB Serial port In the “Serial port’ drop-down box, select the USB serial number which start with lower number. Press ‘OK’...
  • Page 35 (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 If Id is set, the log file name is extended with Id, the file name format is assigned below. - ‘ID_week_month_day_hour_minute_second_year_record.txt’ format (example : STARmed_Fri_Jan_09_19H_14M_01S_2015_record.txt) 7) Display Configuration Set Display Configuration you would like to be displayed.
  • Page 36 (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 - Fix : Set the time axis limits to range from 1 to 99 (5) Monitoring Setting : - Auto Stop : Redraw the graph every time whenever the RF output starts. - Manual Stop : Draw the graph to be continuous even if RF output restarts.

  • Page 37: (Vivalogger)

    (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 Operation and Storage of the Tablet PC linked Monitoring Software (VIVALogger) 1) Install APK Before you can install it on your tablet, you will need to make sure that third-party apps are allowed on your device.
  • Page 38 (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 ⑤ Configuration Setting Serial : Bluetooth setting ‘Scan for devices’ retrieves already discovered or known devices that are nearby. Select a Bluetooth device connecting to the tablet. Once the correct code is entered there will be a notification that the Bluetooth is successfully paired with the tablet.

  • Page 39: Foot Switch Installation And Operations Guide

    (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 Foot Switch Installation and Operations Guide ☞ Foot switch is an optional product accessory. Single Foot Switch Double Foot Switch ☞ Connect the foot switch. Then, tighten the screws.
  • Page 40 (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 A) Single Foot Switch. The foot switch pedal offers the same function as the RF START/STOP button function. Note : Press the switch for more than 1 second to start the RF output. The Single foot Switch has the same function as the RF START/STOP Button...
  • Page 41 (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 B) Double Foot Switch. The foot switch pedals offer the same function as the RF POWER control dial function. Note : (Yellow (-5W), blue (+5W)) Press the Yellow pedal to reduce output. (Pressing and holding the pedal decreases output quickly.) Press the Blue pedal to increase output.

  • Page 42: Explanation Of Symbols

    (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 2.6. Explanation of Symbols RF Generator DEFIBRILLATION-PROOF TYPE BF APPLIED PART Floating return (high frequency) Warning, electricity General warning sign Footswitch input jack Signal input/output port Refer to instruction manual/booklet Equipotentiality Indicates rotational direction of increase (for output control and set output) RF START /STOP...
  • Page 43 (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 Non-ionizing electromagnetic radiation Serial number Manufacturer Date of manufacture Power on Power off Caution: Federal law restricts this device to sale by or on the order of a physician.
  • Page 44 (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 Symbol Meaning To indicate that the transport package shall be kept away from rain and in dry conditions. To indicate that hooks shall not be used for handling the transport package.

  • Page 45: Generator Output Power Characterization

    (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 2.7. Generator Output Power Characterization CONTINUANCE MODE...

  • Page 46: General Mode

    (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 GENERAL MODE * Graphical Displays of Auto Mode and Temperature Mode are same with Graphical Display of Continuance Mode.

  • Page 47: Diagram Of Power Output Data

    (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 Diagram of power output data (1) 200W(Maximum output current : 2A)

  • Page 48: Radiofrequency Lesion Generator Specifications

    (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 2.8. Radiofrequency Lesion Generator Specifications Rated power Voltage range: 100 - 240 V~ Maximum input voltage: 250 V~ Maximum input power: 450 VA Fuse capacity: F 5AH 250 V Power frequency: 50/60 Hz Impedance measurement...

  • Page 49: Peristaltic Pump

    (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 3. Peristaltic Pump Caution Use this Peristaltic pump only after reading the warnings, cautions, and information on  the product’s usage. Use other accessories related to the Peristaltic pump only after reading the warnings, ...
  • Page 50 (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 VP01-1 Description of the pump front part and control part Feature Name Function 1 Handle Handle that use for moving of pump 2 Power Switch Switch that starts and stops the operation of the pump roller Maintains proper contact status between the pump tubing and roller 3 Flip cover...
  • Page 51 (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 Description of the pump’s rear part Feature Name Function 1 MAINS INLET AC Power cable coupler 2 FUSE box Two fuses attached EQUIPOTENTIAL Equipotential coupler for making the equipment besides the main GROUND frame and the electric potential, the same...

  • Page 52: Preparations

    (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 3.2. Preparations Mounting the pump tubing inside of the front part(VP01) Lift up the cover by pushing the TUBE COMMPRESSION LEVER to the left. Mount the tubing to the inner side of the roller head. When mounting, mount the tubing by lifting up the TUBE AUTOMATIC CLAMP.

  • Page 53: Explanation Of Symbols

    (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 3.3. Explanation of symbols Caution Equipotentiality Power on Power off...

  • Page 54: Peristaltic Pump Specifications

    (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 3.4. Peristaltic pump specifications Rated power Input voltage 100 - 240 V~ Frequency 50/60 Hz Consumption power 80 VA (max.) Flow rate (when using while connecting to the electrode tubing set) load = 80ml or higher Flow rate : (no load = 120 ml or higher)

  • Page 55: Rf Electrode

    (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 4. RF Electrode Caution Use RF Electrodes only after reading warning and caution messages and information on  the usage first. Use other accessories related to this RF Electrodes only after reading information on the ...

  • Page 56: Star Rf Electrode (Mono Polar)

    (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 star RF Electrode (mono polar) star RF Electrode (Fixed type) Art. No Electrode length Tip exposure length Gauge Note 17-15s30F 17-20s30F (Unit: mm) 4.2. Treatment Guidelines – Ablation of Tissue Tip Exposure Time Target...

  • Page 57: Technical Reference

    (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 5. Technical Reference Caution Use generator only after reading warning and caution messages and information on the  usage first. Use other accessories related to this generator only after reading information on the ...

  • Page 58: Equipment Waste And Management

    Transportation and Storage Environment Clean, dry area Temperature: -40°C - 40°C Humidity: 0% - 87%, including condensation Atmospheric Pressure: 800 - 1 060 hPa 5.3. Equipment Waste and Management Discard Please call or Consult your local STARmed representative for supporting.

  • Page 59: Cleaning And Disinfection

    (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 5.4. Cleaning and Disinfection The RF Lesion generator for tissue ablation during surgical procedures with coagulation electrode’s reusable components may be cleaned with mild cleaning solutions, such as 70% isopropyl alcohol.

  • Page 60: Maintenance And Service

    The RF lesion generator and pump are not user serviceable, and both units should be returned to STARmed authorized service center if any problems arise. To ensure accuracy of unit outputs and displays, the annual inspection of the unit is recommended by official process. Please call your local STARmed representative for support in detail.

  • Page 61: Emc Declaration

    (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 5.6. EMC Declaration Guidance and manufacturer’s declaration – electromagnetic emissions The VIVA combo RF Generator (VCS10) is intended for use in the electromagnetic environment specified below. The customer or the user of the VIVA combo RF Generator (VCS10) should assure that it is used in such an environment.
  • Page 62 (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 Guidance and manufacturer’s declaration – electromagnetic immunity The VIVA combo RF Generator (VCS10) is intended for use in the electromagnetic environment specified below. The customer or the user of the VIVA combo RF Generator (VCS10) should assure that it is used in such an environment Immunity IEC 60601...
  • Page 63 (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 Guidance and manufacturer’s declaration – electromagnetic immunity The VIVA combo RF Generator (VCS10) is intended for use in the electromagnetic environment specified below. The customer or the user of VIVA combo RF Generator (VCS10) should assure that it is used in such an environment.
  • Page 64 (Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si,Gyeonggi-do, Korea, 10355 Guidance and manufacturer’s declaration – electromagnetic immunity The VIVA combo RF Generator (VCS10) is intended for use in the electromagnetic environment specified below. The customer or the user of VIVA combo RF Generator (VCS10) should assure that it is used in such an environment.

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