Take-Apart Laparoscopic Instruments Instructions for Use

4 Pages

V. Mueller ® Take-Apart Laparoscopic Instruments Catalog Numbers: All products covered by these instructions for use are  Cautions  listed in the appendix.  Devices should be handled and operated by healthcare professionals completely familiar with their use, assembly, and disassembly. Use devices for their intended surgical purposes only. Use of a device for other than that for which it is intended will usually result in a damaged or broken device. Examples: 1. Use of a grasper to hold or guide another device.  Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.  Indications For Use Hand held laparoscopic devices, used with a monopolar electrosurgical current, are intended to be used to grasp/dissect, cut, and cauterize adventitial tissue planes between various ducts and arteries during laparoscopic surgery.  2. Use of a delicate dissector as a grasper. 3. Use of extremely delicate scissors to cut suture.  Hand held laparoscopic devices, used without a monopolar electrosurgical current, are intended to be used as a manipulator to lift, move, clamp, extract and for grasping, cutting and/or dissecting, placing or retracting structures or adventitial tissue.  4. Use of a 5 mm grasper or dissector instead of a 10 mm claw extractor forceps to remove excised tissue through cannula. 5. Use of a delicate dissector to remove clips.  How Supplied  Prior to use, all insulated devices should be inspected to ensure proper insulation. Any interruptions in the coating may compromise the safety of the device. To prevent the possibility of electrical shocks or burns, devices with breaks in the insulation should be returned to an authorized repair service center for repair or replacement.  Devices are packaged as non-sterile. Cleaning and sterilization must occur prior to use.  Only the cleaning and sterilization processes which are defined within these instructions for use have been validated.  Contraindications  Do not use devices if they do not satisfactorily perform their intended function or have physical damage.  These devices are designed to be used through an abdominal portal, the opening maintained by an introducer or cannula which allows for insertion or removal of the device without damage to surrounding soft tissue.  Do not use these devices on patients with pacemakers.  Avoid mechanical shock or overstressing the devices which will cause damage. Make sure distal effectors are completely closed prior to insertion or removal through cannulas.  Warnings Devices shall be used in accordance with these instructions for use. Read all sections of this insert prior to use. Improper use of these devices may cause serious injury. In addition, improper care and maintenance of the devices may render the devices non-sterile prior to patient use and may cause serious injury to patient or health care provider.  Use the appropriate sized cannula for the device being used. For example, use a 5 mm device with a cannula with an inner diameter of at least 5.5 mm. The maximum recurring peak voltage for devices applicable to these instructions for use is 2kV.  To reduce capacitive coupling, the device should only be activated when in position to deliver energy to the target tissue.  Ring handled devices are designed to be held with one finger and the thumb in the ring handles. Do not hold handle in a whole hand pistol grip which applies excessive force and may damage the device.  Capacitive coupling could cause burns and increases risk of shock to the patient.  Always use caution when inserting or removing instruments through cannula. Lateral pressure on the instrument during removal can damage the working tip, shaft of the instrument and/or insulation. Be sure the tips are closed and the instrument is pulled straight out until completely clear of cannula to avoid catching the valve assemblies in cannulas or dislodging the cannula.  When using electrosurgical generators, be sure to follow the manufacturer’s recommendations for patient and staff safety. The patient should be grounded by use of a grounding pad, which is properly connected to the electrical generator. Care should be taken when handling the electrosurgical device so as not to burn the patient and/or surgical drapes. Check for proper grounding of device and patient prior to use. Do not energize the device unless it is visible through the laparoscope. Start with the lowest possible setting on the electrosurgical unit and gradually increase the power to achieve proper cutting and coagulation. The energized device tip has the potential to burn, cut and coagulate tissue. Care should be taken when using this device as contact with surrounding tissue in the field can produce excessive tissue burn.  Follow manufacturer’s instructions for use for HF generators. Devices were designed to the bipolar output of HF Generators with a maximum of 100 watts and a maximum output voltage of 600 V. Remove protective cover from the monopolar connector on handle prior to use. HF cable used must be completely compatible with the adapter plug. Monopolar laparoscopic devices are not compatible with bipolar cautery cables and generators. They are intended only for monopolar cautery usage.  Avoid contact with un-insulated devices and do not use them in the presence of combustible/explosive gases or liquids.  All devices must be cleaned and sterilized before use.  Large vertical movements inside the trocar sleeve should not be carried out in the activated state.  1  R. Cisneroz - 2013  Proofed by: ____________________________ Date: _____________  Dimensions checked: ______________ Copy checked: _____________
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File Name: BD - V.Mueller - CF36-1546A - Take-Apart Laparoscopic Instruments Instructions for Use - 2013-08 - Rev A.pdf

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