GENICON REUSABLE MONOPOLAR X-SURGE SHAFT HANDLE, Инструкция по эксплуатации, Страница: 2 / 25

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EN
– ENGLISH
BEFORE USING THIS PRODUCT, READ THE FOLLOWING INFORMATION THOROUGHLY.
IMPORTANT!
1. This booklet is designed to assist using this product. It is not a reference to surgical techniques
DESCRIPTION
The GENICON X-Surge Monopolar Laparoscopic Instrument Handles are non-sterile packaged reusable monopolar handles intended for use in combination with a
compatible insert (
supplied separately ). It includes graspers, dissectors, and scissors, intended to grasp, manipulate, cut, and cauterize soft tissue ( insert required ).
INDICATIONS FOR USE-
Endoscopic surgical procedures, it is a family of instruments which include graspers, dissectors, and scissors, intended to grasp, manipulate, cut, and cauterize soft
tissue.
CONTRAINDICATIONS
1. The GENICON Monopolar Laparoscopic X-Surge instruments are NOT intended for contraceptive coagulation of fallopian tissue, but may be used to achieve
hemostasis following transaction of the fallopian tube.
2. These devices are intended for use only as indicated.
WARNINGS AND PRECAUTIONS
1. The use of GENICON laparoscopic and endoscopic products is contraindicated whenever endoscopic surgical techniques are contraindicated for any reason.
Contraindications relevant to individual GENICON products are noted in the specific sections.
2. Endoscopic surgery should be performed only by physicians who are thoroughly trained in endoscopic techniques and failure modes, precautions, and corrective
actions in the event of failure.
3. A thorough understanding of the principles and techniques involved in electrosurgical procedures is necessary to avoid shock and burn to both patient and
operator. Verify compatibility of instrumentation, and ensure that electrical insulation or grounding is not compromised.
4. This device is provided NON-STERILE and must be cleaned and sterilized prior to and after each use. Cleaning and sterilization using any other method then
detailed below or more times than specified may result in damage to the device and possible patient injury.
5. Utilize available technology (tissue response generator, active electrode monitoring) to further eliminate concerns about insulation failure, capacitive coupling
and interference with other electrical equipment.
6. Cords should not be
bundled, wrapped around metal instruments affixed to the patient or placed directly on patient’s skin. Antenna coupling may occur when
running the electrosurgical cord parallel to other patient or user contact cords or leads.
7. Do not place electrocautery cable on camera cable to avoid monitor display interference.
8. Do not use a damaged or faulty instrument. Check the instrument for bent, broken, cracked, worn, or separated parts prior to use. Do not use if inspection or
current leakage tests indicate damage. Insulation failures may result in burns or other injuries to the patient or operator.
9. Single Use devices may not be repaired, modified or re-processed.
10. Introduce the instrument through the cannula carefully to avoid damaging the working tip.
11. Transport and store all products safely at ambient temperatures of 5°C to 30°C and relative humidity of 35% to 65 % (non-condensing). Handle with care.
12. DO NOT USE in the presence of flammable anesthetics or oxidizing gases (such as nitrous oxide (N2O) and oxygen) or in close proximity to volatile solvents
(such as ether or alcohol), as explosion may occur.
13. Adjust the HF-output power to match with the intended procedure. Use the lowest possible power setting that will achieve the desired surgical effect. Such as
the low-voltage waveform (cut) and brief intermittent activation. This will reduce the potential for capacitive coupling and/or inadvertent burning of tissues.
14. Do not use power settings that may result in more than 120W being delivered to the GENICON monopolar laparoscopic instruments. Excessive power levels
may result in instrument malfunction and possible patient or user injury. The rated voltage for these device is 3800 Vp.
15. Compatibility of parts from different manufacturers must be verified prior to conducting the procedure.
16. The devices are intended for use with electrosurgical generators and accessories in compliance with safety standards IEC 60601-1, IEC 60601-1-2, and IEC
60601-2-2 including applicable national/regional differences. Refer to the electrosurgical generator manual to verify compatibility and corresponding settings.
Follow all safety precautions.
17. Ensure device grasping or cutting surfaces are fully visible prior to engaging the electrical current to avoid unintended results. Keep the working-end under full
and unobstructed visualization during use.
18. Damage to instrument may occur if attempting to cut staples, clips, or other non tissue based materials.
19. Use appropriate technique to achieve hemostasis if not present after removal of instrument.
20. Do not activate in close proximity or direct contact with another instrument, such as clips, staple, laparoscope, etc. Do not active the instruments in contact with,
in close proximity to, or in conjunction with conductive fluids (e.g. blood or saline). This may alter the electrical path and cause unintended tissue damage.
21. Electrosurgical devices used in conjunction with a laser/Argon beam may create the potential for the development of a gas embolism.
22. Do not activate the instrument when not in contact with target tissue, as this may cause injuries due to capacitive coupling with other surgical equipment or
cause damage to the device
23. Electrosurgical generators may cause unintended destruction of tissue and are dangerous if operated improperly. Follow all instructions for use required by the
generator manufacturer.
24. Mono-polar products should be connected ONLY to a mono-polar power connection on the generator.
25. Do not use excessive force or in a manner not consistent with normal instrumentation use.
26. Do not use in patients who have electronic implants such as cardiac pacemakers without first consulting a qualified professional (e.g., cardiologist). A possible
hazard exists because interference with the action of the electronic implant may occur, or the implant may be damaged.
27. The surface of the active electrode may remain hot enough to cause burns after the RF current is deactivated.
28. Due to concerns about the carcinogenic and infectious potential of electrosurgical byproducts (such as tissue smoke plume and aerosols), protective eyewear,
filtration masks, and effective smoke evacuation equipment should be used in both open and laparoscopic procedures.
29. Keep the active electrodes clean. Build-
up of eschar may reduce the instrument’s effectiveness. Do not activate the instrument while cleaning. Injury to operating
room personnel may result.
30. When the active electrode is not being used, it should be placed in an insulated holster. Do not place instrument on the patient or in contact with flammable
materials (such as gauze or surgical drapes). Instruments that are activated or hot from use may cause a fire or patient burns.
31. The device must be carefully inspected prior to and after each use, including compatible handles and related accessories. Devices with moving parts should
be evaluated for proper function prior to application. Do not use a damaged or faulty instrument. Check the instrument for bent, broken, cracked, worn, or
separated parts prior to use. Do not use if inspection or current leakage tests indicate damage.
POTENTIAL COMPLICATIONS FOR ALL GENICON® PRODUCTS
Potential complications associated with the use of laparoscopic devices include but are not limited to organ or vessel damage/perforation, hemorrhage, hematoma,
trocar site hernia, and septicemia/infection.
INSTRUCTIONS FOR USE