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joimax Endovapor 2 User Manual

Radio frequency electrosurgical unit
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User Manual
Radio Frequency Electrosurgical Unit

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Summary of Contents for joimax Endovapor 2

  • Page 1 User Manual Radio Frequency Electrosurgical Unit...
  • Page 2 Rev.012; 2021-10-04; English © joimax ® GmbH Page 2/68...

  • Page 3: Table Of Contents

    LEANING AND ISINFECTION OF THE ONTROL NIT AND WITCH 10.2 R EPROCESSING OF THE EUTRAL LECTRODE ONNECTING ABLE 10.2.1 Pre-treatment 10.2.2 Cleaning and Disinfection 10.2.3 Inspection 10.2.4 Packing 10.2.5 Sterilization 10.2.6 Storage Rev.012; 2021-10-04; English © joimax ® GmbH Page 3/68...
  • Page 4 SERVICE / MAINTENANCE 13.1 R EPLACING THE TROUBLESHOOTING 14.1 S YSTEM NFORMATION 14.2 EASY N EUTRAL LECTRODE ONITORING WARRANTY CONSUMABLES / ACCESSORIES COMPATIBILITY DISPOSAL OF THE DEVICE EMERGENCY NUMBER MANUFACTURER INFORMATION Rev.012; 2021-10-04; English © joimax ® GmbH Page 4/68...

  • Page 5: Legal Notes

    1.1 Liability All procedures, notes and warnings described in this manual do not release the operator/user from his or her responsibilities regarding clinical judgment, experience and best clinical practice. Rev.012; 2021-10-04; English © joimax ® GmbH Page 5/68...

  • Page 6: General Description

    General Description The joimax ® Endovapor ® 2 is a compact high performance, high frequency energy source that can be used for a variety of RF surgical applications. It represents a radio wave technology with high surgical precision, versatility and safety. All device settings are pre-programed for numerous standard procedures and can be customized to preferences.

  • Page 7: Signs And Symbols

    (During activation of the RF device, RF energy in the radio frequency range 9 kHz to 400 GHz is applied, which produces electromagnetic radiation) Dangerous voltage Equipotential (potential equalization) Foot switch connector Rev.012; 2021-10-04; English © joimax ® GmbH Page 7/68...

  • Page 8: Device Label

    Serial interface (UART communication interface) IP XX Ingress protection class according to IEC 60529 Temperature limitation Humidity limitation Atmospheric pressure limitation Keep away from rain Keep away from sunlight Non-sterile Medical Device 3.1 Device Label Rev.012; 2021-10-04; English © joimax ® GmbH Page 8/68...

  • Page 9: Intended Purpose And Characteristics

    ® 2 is a smart all-in-one RF generator. It features a clearly understandable operating design and innovative functionalities. It includes pre-programed device settings for numerous standard procedures and joimax ® special spine procedures. Four separate outputs can individually be configured.

  • Page 10: Principles Of Operation

    It includes a glass different connectors. front with control elements for adjustment of device settings. Rev.012; 2021-10-04; English © joimax ® GmbH Page 10/68...

  • Page 11: Scope Of Delivery

    Scope of Delivery After delivery of the joimax ® Endovapor ® 2, the packaging must be checked for external damage. If any components are damaged or missing, please contact joimax ® customer service. Item number Item description JEVS0201 joimax ®...

  • Page 12: Safety And Warning Notes

    Warning: Always use non-conductive irrigation fluid with monopolar programs and conductive irrigation fluid with bipolar modes for proper functionality of the device and to avoid potential hazards for the patient. Rev.012; 2021-10-04; English © joimax ® GmbH Page 12/68...
  • Page 13 To place anti-static cloths between areas with heavy sweating and skin-to-skin contact areas on the patient’s torso. • That the patient is resting on a suitable surface in order to prevent pressure necrosis. • To drain urine via a catheter. Rev.012; 2021-10-04; English © joimax ® GmbH Page 13/68...
  • Page 14 Ensure that no ignitable endogenous gases are present. Warning: Ensure that all materials saturated with oxygen (e.g. cotton or gauze) are kept far away from the RF environment, so that they cannot ignite. Rev.012; 2021-10-04; English © joimax ® GmbH Page 14/68...

  • Page 15: Installation And Commissioning

    Make sure that a minimum distance of 15 cm (6”) is maintained between the back of the device and other objects. All ventilation openings must not be obstructed. The device is recommended to be installed in the joimax ® endoscopic trolley.
  • Page 16 Bipolar 3: Socket connector for bipolar instruments with foot switch, hand switch or AUTOSTART* Bipolar 4: Socket connector for bipolar instruments with foot switch, hand switch or AUTOSTART* * Applied part type CF according to IEC 60601-1 Rev.012; 2021-10-04; English © joimax ® GmbH Page 16/68...

  • Page 17: Connecting The Control Unit To A Power Supply Network And Potential Equalization

    Bovie (foot switched) 4 mm (0,16 ″) socket (foot switched) 1. Connect the monopolar handpiece to one of the two monopolar socket connectors. If using a handpiece without buttons, connect a foot switch. Rev.012; 2021-10-04; English © joimax ® GmbH Page 17/68...

  • Page 18: Connecting The Foot Switch

    Use the black changeover switch to switch between two selected monopolar and/or bipolar socket connectors. Foot switches without a black changeover switch cannot be used. Rev.012; 2021-10-04; English © joimax ® GmbH Page 18/68...

  • Page 19: Functional Test

    7) Now change to a mode without AUTOSTART and use the foot switch to activate the bipolar output. Check the settings and indicators in the bipolar section. The neutral electrode used for this test may not later be used for an operation. Rev.012; 2021-10-04; English © joimax ® GmbH Page 19/68...

  • Page 20: Operation

    Operation For protection of personnel, joimax ® recommends the usage of a fume vent, to withdraw electrosurgical fumes. 8.1 Control Elements Front Panel Button “On/Off” Activation indication Monopolar 1 Operating and confirmation buttons Activation indication Monopolar 2 “OK”, “Up” and “Down”...

  • Page 21: Starting The Device

    Press the “Menu” button to show the following menu dialogs: Switch to the required function with the horizontal arrow keys, and press the appropriate selection button to open the menu. Press the “OK” button to return to the main screen. Rev.012; 2021-10-04; English © joimax ® GmbH Page 21/68...

  • Page 22: System Settings

    3. Confirm the selection with the “OK” button.  The main screen is displayed. - or- To return to the main screen without changing the selection, select “Back” or tap any button outside the selection menu. Rev.012; 2021-10-04; English © joimax ® GmbH Page 22/68...

  • Page 23: Language

    8.4.7 Service In the "Service" dialog contact information is displayed, after entering a password, you can use the dialog to access additional options. With the password 001224 you enter the service level. Rev.012; 2021-10-04; English © joimax ® GmbH Page 23/68...

  • Page 24: Key Lock

    Save device setting With the function “Backup device” device settings can be saved on a USB storage, e.g. the joimax ® USB sticks JMUSB20 (4GB) or JMUSB10 (16GB). This includes all stored programs and system settings. Transfer device settings Use "Restore device" to transfer saved device settings from a USB storage to the Endovapor ®...

  • Page 25: Setting Power Output And 8.8 Activating And Deactivating

    To minimize the risk of injury to the patient, set the power and the effect as low as possible. • For usage in spine surgery use the joimax ® spine modes. The activation indications and buttons to set the output power and the effect are allocated next to the corresponding sockets.

  • Page 26: Selecting The Neutrale

    To return to the main screen without changing the selection, tap any button outside the selection menu. The selected type of neutral electrode in connection with a colour-indicator for the contact  quality is shown in the status bar. Rev.012; 2021-10-04; English © joimax ® GmbH Page 26/68...

  • Page 27: Easy Neutral Electrode Monitoring

    Split neutral electrode not detected, not contact quality not connected, or just optimum (yellow) insufficient contact quality (red) Split neutral electrode not connected Display the contact quality or contact quality insufficient (red) Rev.012; 2021-10-04; English © joimax ® GmbH Page 27/68...

  • Page 28: Mode Overview

    This mode is used for contact coagulation with low tissue penetration, preferably using fine electrodes and electrodes with small contact areas. It achieves a high degree of coagulation with low cutting tendency. Suitable instruments Ball electrodes, knife electrodes, spatula electrodes Rev.012; 2021-10-04; English © joimax ® GmbH Page 28/68...
  • Page 29 2 quickly adjusts the power output to the minimum required level in response to variations in tissue type and changes in the cutting area or speed. Suitable instruments Needle electrodes, knife electrodes, spatula electrodes, sling electrodes Rev.012; 2021-10-04; English © joimax ® GmbH Page 29/68...

  • Page 30: Bipolar Modes

    This mode is used in minimal invasive spine surgery for endoscopic dissection and coagulation of tissue and for hemostasis. Suitable instruments joimax ® Vaporflex ® handle and probe bipolar, joimax ® Legato ® handpiece and probe bipolar Rev.012; 2021-10-04; English © joimax ®...
  • Page 31 This mode is used in minimal invasive spinal surgery for endoscopic treatment of the facet joint for denervation and surface coagulation. Suitable instruments joimax ® Vaporflex ® handle and probe bipolar, joimax ® Legato ® handpiece and probe bipolar Standard This mode is used for arcless contact coagulation with forceps.
  • Page 32 Bipolar scissors This mode is used with bipolar scissors. It can be used for coagulation before or during cutting, point coagulation, coagulation of cuts and surface coagulation. Suitable instruments Bipolar scissors Rev.012; 2021-10-04; English © joimax ® GmbH Page 32/68...

  • Page 33: Cleaning And Disinfection Of The 10.2 Reprocessing Of The Neutral

    ® 2 Control Unit and Foot Switch, use of Mikrozid ® sensitive wipes (Schülke & Mayr) is recommended by joimax ® GmbH. Pay particular attention to the connectors at the front of the control unit. Make sure to let them dry thoroughly before connecting any components.

  • Page 34: Pre-Treatment

    10.2 Reprocessing of the Neutral Electrode Connecting Cable Warning: The joimax ® Neutral Electrode Connecting Cable is not suitable for ultrasonic cleaning. Warning: Immediately after use (within a maximum of 2 hours), coarse soiling must be removed from the cable by applying the pre-treatment steps according to chapter 10.2.1.

  • Page 35: Inspection

    Applicable national legal regulations must be observed. It is not recommended to use other sterilization methods (such as flash sterilization, hot air sterilization, radiation sterilization, formaldehyde or ethylene oxide sterilization, plasma sterilization). Rev.012; 2021-10-04; English © joimax ® GmbH Page 35/68...
  • Page 36 AAMI ST79, for USA: FDA clearance) • the steam sterilizer is validated according to EN ISO 17665 (valid IQ/OQ (commissioning) and product specific performance qualification (PQ)) The joimax ® Neutral Electrode Connecting Cable can be sterilized using the following procedures:...
  • Page 37 Dosage monitoring with fault indication on the display  Continuous self-test  Continuous status indication on the display  Operating errors shown on the display Text messages with further information Rev.012; 2021-10-04; English © joimax ® GmbH Page 37/68...
  • Page 38  Operating errors  Data retrieval via the display Text messages with further information Communication USB interface for software updates  External PC interface, UART, using joimax ® software.  Service support using joimax ® software Capacitive Touchoperation, 3,5‘‘ TFT-Display, ...
  • Page 39 Relative humidity 10 % - 100 % 0 % - 100 % Atmospheric pressure 800 hPa - 1060 hPa 500 hPa - 1100 hPa Operating altitude (max) 2000 m a. sea level Rev.012; 2021-10-04; English © joimax ® GmbH Page 39/68...
  • Page 40 450 Vp 450 Vp 1.4 kVp 1.4 kVp 1.4 kVp 1.4 kVp sinusoidal 1 W - 0.64 1.5 kVp modulated 200 W Arms 1.6 kVp 1.6 kVp 1.6 kVp 1.6 kVp Rev.012; 2021-10-04; English © joimax ® GmbH Page 40/68...
  • Page 41 550 Vp modulated 60 W Arms Bipolar sinusoidal 1 W - 1.64 400 Vp cutting constant 200 W Arms Bipolar sinusoidal 1 W - 1.27 200 Vp scissors constant 120 W Arms Rev.012; 2021-10-04; English © joimax ® GmbH Page 41/68...
  • Page 42 Table of RF output voltage U [Vp] as a function of the setting "Monopolar Coagulation: Moderate" (idle mode). Diagram of power output P [W] as a function of the setting "Monopolar Coagulation: Moderate". Rated load resistance= 75 . Rev.012; 2021-10-04; English © joimax ® GmbH Page 42/68...
  • Page 43 "Monopolar Coagulation: Forced mixed" (idle mode). Diagram of power output P [W] as a function of the setting "Monopolar Coagulation: Forced mixed". Rated load resistance = 500 . Rev.012; 2021-10-04; English © joimax ® GmbH Page 43/68...
  • Page 44 Table of RF output voltage U [Vp] as a function of the setting "Monopolar Coagulation: Spray" (idle mode). Diagram of power output P [W] as a function of the setting "Monopolar Coagulation: Spray". Rated load resistance = 500 . Rev.012; 2021-10-04; English © joimax ® GmbH Page 44/68...
  • Page 45 U [Vp] setting "Monopolar Coagulation: Resection" (idle mode) = 2600 Vp. Diagram of power output P [W] as a function of the setting "Monopolar Coagulation: Resection". Rated load resistance = 500 . Rev.012; 2021-10-04; English © joimax ® GmbH Page 45/68...
  • Page 46 Diagram of power output P [W] as a function of setting "Monopolar Cutting: Micro". Rated load resistance = 500 . Table of RF output voltage U [Vp] as a function of the setting "Monopolar Cutting: Micro" (idle mode). Rev.012; 2021-10-04; English © joimax ® GmbH Page 46/68...
  • Page 47 Table of RF output voltage U [Vp] as a function Table of power output P [W] as a function of the of the setting "Monopolar Cutting: Resection" setting "Monopolar Cutting: Resection". (idle mode). Rated load resistance= 500 . Rev.012; 2021-10-04; English © joimax ® GmbH Page 47/68...
  • Page 48 RF output voltage U [Vp] for the setting "Bipolar Coagulation: Spine Coag" (idle mode) = 150 Vp. Diagram of power output P [W] as a function of the setting "Bipolar Coagulation: Spine Coag". Rated load resistance = 50 . Rev.012; 2021-10-04; English © joimax ® GmbH Page 48/68...
  • Page 49 RF output voltage U [Vp] for the setting "Bipolar Coagulation: Standard" (idle mode) = 150 Vp. Diagram of power output P [W] as a function of the setting "Bipolar Coagulation: Standard". Rated load resistance = 50 . Rev.012; 2021-10-04; English © joimax ® GmbH Page 49/68...
  • Page 50 RF output voltage U [Vp] for the setting "Bipolar Coagulation: Laparoscopy" (idle mode) = 150 Vp. Diagram of power output P [W] as a function of the setting "Bipolar Coagulation: Laparoscopy". Rated load resistance = 50 . Rev.012; 2021-10-04; English © joimax ® GmbH Page 50/68...
  • Page 51 RF output voltage U [Vp] for the setting "Bipolar Coagulation: Forced" (idle mode) = 550 Vp. Diagram of power output P [W] as a function of setting "Bipolar Coagulation: Forced". Rated load resistance = 50 . Rev.012; 2021-10-04; English © joimax ® GmbH Page 51/68...
  • Page 52 RF output voltage U [Vp] for the setting "Bipolar Cutting: Spine Vap" (idle mode) = 550 Vp. Diagram of power output P [W] as a function of the setting "Bipolar Cutting: Spine Vap". Rated load resistance = 75 . Rev.012; 2021-10-04; English © joimax ® GmbH Page 52/68...
  • Page 53 RF output voltage U [Vp] for the setting "Bipolar Cutting: Bipolar scissors" (idle mode) = 200 Vp. Diagram of power output P [W] as a function of the setting "Bipolar Cutting: Bipolar scissors". Rated load resistance = 75 . Rev.012; 2021-10-04; English © joimax ® GmbH Page 53/68...

  • Page 54: Emc Notes

    The Endovapor ® 2 LED is suitable for use in professional healthcare facility environments according to IEC 60601-1-2:2014 (Ed.4). Rev.012; 2021-10-04; English © joimax ® GmbH Page 54/68...
  • Page 55 Power frequency magnetic fields frequency 50 Hz or 60 Hz 50 Hz or 60 Hz should be at levels characteristic of magnetic fields a typical location in a typical commercial or hospital environment. Rev.012; 2021-10-04; English © joimax ® GmbH Page 55/68...
  • Page 56 / IEC 61000-4-4 100 kHz repetition 100 kHz repetition voltage must be that of a bursts frequency frequency typical business or hospital Surges environment. IEC 61000-4-5 ±2 kV ±2 kV Line-to-ground Rev.012; 2021-10-04; English © joimax ® GmbH Page 56/68...
  • Page 57 25; UMTS Bluetooth, WLAN, 2400 - Pulse modulation 2450 802.11 b/g/n, RFID 2570 217 Hz 2450, LTE Band 7 5240 5100 - WLAN 802.11 Pulse modulation 5500 5800 217 Hz 5785 Rev.012; 2021-10-04; English © joimax ® GmbH Page 57/68...

  • Page 58: Service & Maintenance

    5) Plug the power cord into the control unit. 6) Turn on the device via the power switch at the backside, press the button “On/Off” at the device front and check the function of the device. Rev.012; 2021-10-04; English © joimax ® GmbH Page 58/68...
  • Page 59 The cable for neutral electrode has been removed. Monopolar activation is not possible. Mode Error No mode selected. No mode was selected for this type of activation.  Select the desired mode or change the foot switch assignment. Rev.012; 2021-10-04; English © joimax ® GmbH Page 59/68...
  • Page 60 The annual Technical Safety Inspection (TSI) for Endovapor ® 2 is due.  Please contact the joimax ® technical support Internal Error 4177  If this message appears, please contact the joimax ® technical support. Rev.012; 2021-10-04; English © joimax ® GmbH Page 60/68...
  • Page 61 Check the neutral electrode and neutral electrode cable. An acoustic signal Loosened electrode.  Re-attach the neutral sounds and a warning electrode. If the error message appears on the persists, replace it. display. Rev.012; 2021-10-04; English © joimax ® GmbH Page 61/68...

  • Page 62: Warranty

    Warning: In case of return of equipment or accessories, original packaging material must always be used! Warning: To protect your staff and the joimax ® GmbH employees, please clean the device and its accessories and disinfect it before sending it.

  • Page 63: Consumables / Accessories

    Make sure to follow the instructions for use of accessories to be used with the device (e.g. handpieces, RF probes etc.). Consumables All consumables are provided by joimax ® GmbH. Replacements for all consumables can be ordered from joimax ® GmbH or via the respective local joimax ® distributor. Item number Description JEVN0001 joimax ®...
  • Page 64 17 Compatibility Warning: When using the joimax ® Endovapor ® 2 Spine mode modes • Neurotomy • Spine Vap • Spine Coag • Bipolar Neurotomy only original joimax ® RF instruments may be used. Operating conditions of RF instruments (e.g. handpieces and probes) used in combination with the device may differ.
  • Page 65 ® RF instruments and accessories can be found in the data sheet RF program and in the product catalog. Modifications are subject to change. For further information and new products directly contact the joimax ® customer service or your joimax ®...

  • Page 66: Disposal Of The Device

    Discard used and contaminated medical devices at a collection point of an appropriate disposal carrier. “Medical waste” is classified according to dangerous goods law (for transportation) by UN number UN 3291. Rev.012; 2021-10-04; English © joimax ® GmbH Page 66/68...

  • Page 67: Emergency Number

    (MPDG) or § 3 Medizinprodukte-Sicherheitsplanverordnung (MPSV) at the following telephone number: For the US +1 949-859-3472 (24-hour availability) For all other countries +49 (0)721 25514 – 999 (24-hour availability) Thank you for your support! Rev.012; 2021-10-04; English © joimax ® GmbH Page 67/68...
  • Page 68 ® . Other products and names used here may be the registered brands of other companies. Patents are registered. Copyright © 2021 joimax ® GmbH. All rights reserved. Caution: U.S. Federal Law restricts this device to sale by or on the order of a physician.

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