Instructions for Use
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SonaStar Handpiece Instructions for Use
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For additional information not contained in this manual, please visit www.misonix.com or contact your local sales representative.
1.
General Safety Statements
WARNING
The neXus® Ultrasonic Surgical Aspirator System is an electro-mechanical device, which under certain circumstances could present an electrical shock hazard to the operator and/or patient. Please read manual thoroughly and follow directions stated herein to assure maximum safety during operation. This manual shall be kept in close proximity to the system for easy referral when needed.
WARNING
The neXus® Ultrasonic Surgical Aspirator System is intended to be used in various types of invasive, surgical procedures. There may be indirect danger to the patient should the device fail during the procedure. It is recommended that the facility follows its back-up equipment protocols.
CAUTION
Special Skills Training Requirements
1.1.
•
U.S. federal law restricts this device to sale by, or on the order of a licensed healthcare practitioner.
•
The NeXus® Ultrasonic Surgical Aspirator System is to be used by an appropriately trained and licensed healthcare practitioner.
•
All Hospital personnel are trained in universal precautions and use of PPE
Summary of Safety Notices
Please read this section of the manual carefully. It contains a summary of all precaution, warning and caution statements contained in the manual. However, the user is advised to read the entire manual and operate the device only in accordance with all of the instructions contained herein. Servicing of this device should only be performed by qualified technicians authorized by Misonix, Inc. There are no service controls accessible to the user.
Conventions on Warnings and Cautions WARNING
Denotes potentially dangerous situation that could result in death or serious injury to patient, operator or staff.
CAUTION
A caution contains information regarding any special care to be exercised by the practitioner and/or patient for the safe and effective use of the device.
Table 1.1: Conventions on Warnings and Cautions 2 | P a g e Instructions For Use | neXus® Sonastar Handpieces 100-24-1000 rev B
1.2.
List of Warnings
The neXus® Ultrasonic Surgical Aspirator System is an electro-mechanical device, which under certain circumstances could present an electrical shock hazard to the operator and/or patient. Please read manual thoroughly and follow directions stated herein to assure maximum safety during operation. This manual shall be kept in close proximity to the system for easy referral when needed.
The neXus® Ultrasonic Surgical Aspirator System is intended to be used in various types of surgical procedures. There may be indirect danger to the patient should the device fail during the procedure. It is recommended that the facility follows its back-up equipment protocols.
Explosion Hazard: Never use the neXus® Ultrasonic Surgical Aspirator System in the presence of a flammable or explosive atmosphere, such as flammable anesthetics.
Only use the SonaStar Long or Short handpiece with probe accessory kit configurations for the indications for use charted in Section 2.1
Tip and irrigation temperatures may exceed the tissue necrosis point if insufficient irrigation flow rates are used. For hard tissue removal, set the irrigation flowrate to a setting no less than the comparable vibration setting. For example, if the vibration setting is 70, a minimum flow setting of 70% should be used. Additional external irrigation, e.g. by administering sterile saline with a syringe over the distal tip portion, may be necessary for removal of very dense, hard osseous structures.
Tissue necrosis may result if tip is not moved relative to tissue. A continuous, lateral sweeping motion is recommended in order to minimize contact duration with the ultrasonic tip and minimize heat build-up. When lateral motion is not possible withdraw and re-insert tip frequently.
Contact to vibrating elements like extension and ultrasonic tip may cause burns and should be avoided by all means. The handpiece should only be held at the black housing area. An optional, protective silicone sleeve, included with certain tips, reduces the risk of thermal damage but does not eliminate it. Contact with the silicone sleeve should be avoided or kept brief with minimal amount of contact pressure. Pressure and extended exposure can still result in excessive frictional heat and cause burns.
Ultrasonic tips can break under excessive use in extreme conditions, e.g. when cutting for extended / duration in tight cavities with limited lateral motion. The tip could break into two or more fragments with the main fragment remaining attached to the handpiece. All fragments must be retrieved immediately from the surgical site. The fragments should be checked to ensure that no further pieces are missing. It is possible that a fragment is propelled outside of the surgical cavity. Diagnostic imaging, such as X-ray, must be used if a fragment cannot be found to confirm that the broken piece is outside of the surgical cavity.
Breakage of ultrasonic tips will result in sharp edges that can be harmful to soft tissue even without activation of ultrasound. Tips can bend or deform before they actually brake. Tips showing signs of deformation or cracking should be replaced immediately since tip breakage is otherwise imminent. Do not bend or twist the ultrasonic tips since it reduces the structural integrity and can result in tip breakage during use. Dispose of deformed or broken tips immediately in a sharps container.
Improper connection of the handpiece cable may present a shock hazard. Confirm that handpiece connector is dry prior to plugging it in.
The neXus Long or Short Handpieces can deliver RF energy via its attached probe tip when connected to a 3rd party electrosurgical generator using the RF Monopolar Handswitch Cable accessory. Misonix recommends use of the electrosurgical generators listed in Table 4.5 that have been validated for compatibility with the neXus system.
DO NOT use any electrosurgical device that exceeds a peak electrosurgical output of 4.5KV in the
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coagulation mode (COAG) to avoid electrical shock.
Improper assembly of Single-Use Monopolar Handswitch Cable to endcap can expose potentially dangerous electrosurgery voltage. To avoid poor electrical connection, always make sure the Single-Use Monopolar Handpiece Cable socket is firmly and fully engaged onto the pin in the endcap. Inspect the silicone sleeve near the probe tip for cracks that may expose the probe (active electrode)
Improper connection of the RF monopolar fingerswitch cable may present a shock hazard. Always use gloved, dry hands when plugging it in to the electrosurgical generator and handpiece.
Always place the neXus SonaStar handpiece with the monopolar handpiece cable attached on a nonconductive surface when not in use for monopolar cautery.
Always use the lowest possible generator setting that will achieve the desired cauterization effect. When higher than necessary voltages are used, the potential for arching are increased.
Clean the neXus SonaStar tip frequently when using the tip for electrocautery. As eschar builds up on the tip, electrical impedance increases, and this can cause arching, sparking or ignition and flaming of the eschar. Clean with a nonabrasive sterile pad to prevent scratching of the probe tip. Scratch groves will increase eschar build up and can effect ultrasonic surgical performance of the tip.
Do not wrap the neXus monopolar cable around metal instruments with sharp corners or features that can damage the cable and cause electrical shock and/or loss of function.
Interference produced by the operation of recommended electrosurgical systems may adversely influence the operation of other electronic equipment.
Use the neXus monopolar interface cable with caution in the presence of internal or external pacemakers or other active implanted devices. Interference produced by the recommended electrosurgical systems can cause a pacemaker or other active implantable device to malfunction, enter an unsafe mode, or cause permanent damage to the device. Consult the pacemaker manufacturer or responsible hospital department for qualified advice when using the neXus monopolar interface cable for electrocautery in patients with external or internal pacemakers or active implantable medical devices.
Heat is being generated at the tip/tissue interface. A continuous, lateral sweeping motion is recommended for general bone/tissue removal in order to minimize contact duration with the ultrasonic tip and minimize the temperature increase.
Remove probe cover, ultrasonic tip and extension from the handpiece prior to cleaning and/or sterilization; otherwise proper cleaning/sterilization may be inhibited.
Single-use items (tips, sheaths, tubing sets) are marked with the international symbol for “do not reuse - single use only” ( ). Discard these items following each surgical procedure in accordance with the hospital protocol for biohazardous waste. Tips are to be disposed of in a biohazardous sharps container.
All reusable handpiece parts and accessories must be properly decontaminated, cleaned and sterilized before each use as per instructions contained in this manual. Failure to do so may lead to infections, which can ultimately cause patient death.
Misonix Inc. has validated all cleaning and sterilization cycles given in this manual. It is highly recommended that the procedures given in this manual for cleaning and sterilizing the neXus® Ultrasonic Surgical Aspirator System and related accessories be followed. It is the responsibility of the user of this device or any accessories used with it to validate procedures for cleaning and/or sterilization if they differ from the
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procedures as outlined in this manual.
The disposable items are intended for one procedure only (single use). Do not attempt to reuse or re-sterilize.
The neXus® Ultrasonic Surgical Aspirator System and its accessories may emit harmful acoustic pressure if exposure exceeds recommended limits.
No Modifications of this equipment is allowed except as noted for cleaning and sterilization. The user should return to Misonix or an authorized service center.
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1.3. List of Cautions
Special Skills Training Requirements o
U.S. federal law restricts this device to sale by, or on the order of a licensed healthcare practitioner.
o
The NeXus® Ultrasonic Surgical Aspirator System is to be used by an appropriately trained and licensed healthcare practitioner.
o
All Hospital personnel are trained in universal precautions and use of PPE.
The use of accessories, transducers and cables other than those specified may result in increased emissions or decreased immunity of the device. Use only Misonix branded equipment and accessories.
Ultrasonic energy is inhibited if excessive physical force is applied to the ultrasonic tip; use only enough force to guide the tip to the surgical site and to advance it through the tissue. Do not force the tip; allow the ultrasonic action to do the work.
This Instructions for Use Manual provides instructions on using the neXus SonaStar Handpiece. Refer to the neXus Console Instructions for Use Manual prior to using the neXus Ultrasonic Surgical Aspirator System.
Insufficient irrigation and high tip pressure (loading) under extended exposure, e.g. in tight cavities, are to be avoided while removing hard tissue. It is recommended to withdraw and re-insert the ultrasonic tips (e.g. Blades & Shavers) repeatedly to re-establish adequate cooling and lubrication.
Additional external irrigation, e.g. by administering sterile saline with a syringe over the distal tip portion, may be necessary when removing very dense, hard osseous structures.
All reusable system components like handpiece, probe covers, counter wrench, and T-wrench are supplied industrially cleaned, but NON-STERILE. All items intended for use in the sterile field must be cleaned and sterilized as per the indicated instructions before first clinical use and before every subsequent clinical use.
All items intended for use in the sterile field must be cleaned and sterilized as per indicated instructions before each clinical use.
The disposable items are intended for one procedure only (single use). Do not attempt to reuse or re-sterilize.
Prime the irrigation tubing prior to use. At all times ensure that the irrigation flows towards the handpiece when footswitch is depressed. If no irrigation is flowing, cease use until flow is restored.
The system check should always be done in advance of preparing patient for surgery to minimize risk to patient in case of system malfunction.
Ensure all connections and mating surfaces of handpiece, extension and ultrasonic tip are clean and dry before assembly.
Do not use ultrasonic cleaners to clean the handpiece as this method could damage handpiece.
Be certain to clear debris from all internal passages by brushing. Failure to do so may hinder sterilization of units during autoclaving.
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Do not immerse ultrasonic console, handpiece, irrigation pump, or electric cables. These items are not sealed against liquids and damage to equipment will result.
Ensure all connections and mating surfaces of handpiece, extension and ultrasonic tip are clean and dry before assembly.
Studies have shown that smoke generated during electrosurgical procedures can be potentially harmful to patients and the surgical team. These studies recommend adequately ventilating the smoke by using a surgical smoke evacuator or other means. Refer to the 3rd party electrosurgical generators user manual for more information regarding the evacuation of smoke.
Loose tip/tissue contact upon an initial bone incision can cause a thin tip to resonate not only longitudinally but also transversely. This can cause a thin tip to break. It is necessary to engage bone actively and with a minimal tip pressure greater than zero in order to prevent the shattering.
Contact of the ultrasonic tip or the exposed extension with metal, surgical instruments or other objects during ultrasound use must be avoided. Such contact can damage the ultrasonic components very easily and may result in compromised performance, including failure. Discard any extensions or tips that show signs of damages like gouges, nicks or fractures. External aspiration may be used but it is recommended that a plastic suction tip should be used when in proximity with the probe tip.
The handpiece must be placed into the counter wrench. Do not attempt to tighten or loosen handpiece components by holding the handpiece case or endcap. Always use the T-wrench wrench when tightening or un-tightening the tip or an extension. Never apply a pipe or strap wrench to the handpiece case. Do not over-tighten the tip or the extension.
Always tighten or un-tighten the probe cover by hand and without using any wrenches. Do not over- tighten the probe cover.
Always hold the handpiece at its metallic endcap when tightening or un-tightening the irrigation tubing. Always tighten or un-tighten the irrigation tubing by hand and without using any wrenches. Do not over- tighten the tubing connector.
Allow reusable, autoclavable items to gradually return to room temperature after steam sterilization and prior to usage.
The reuse life given takes into account wear and tear due to cleaning and sterilization only. Damage or wear caused by actual use in treatments will affect life of components.
1.4.
Trademark Information
Misonix®, SonaStar® are registered trademarks of Misonix, Inc., Farmingdale, NY
ASP Enzol® and Prolystica® are registered trademarks of STERIS Corporation, Mentor, OH
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1.5.
Explanation of Symbols Misonix CE number
Contains DEHP and/or Phthalates
Caution: Consult accompanying documents
Restricted to sale by or on the order of a physician only
Manufacturer
Consult Instructions for Use
Sterilized using Ethylene Oxide
ABC123
Lot or Batch Code
Authorized Representative
Warning: Hearing Protection
Disposal to be compliant with EN 50419 (WEEE directive)
Catalog number Table 1.2: Symbol Definitions
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2.
Indications and Contra Indications 2.1. Indications The Misonix Inc. neXus® Ultrasonic Surgical Aspirator System is intended for the fragmentation, emulsification and aspiration of both soft and hard (i.e.bone) tissue. The indications for use for the for the SonaStar Long and Short Handpieces in combination with SonaStar probe kit accessory configurations are charted below.
NEXUS INDICATIONS FOR USE BY HANDPIECE AND PROBE KIT ACCESSORY COMBINATION Long and Short Handpiece for use with SonaStar® Indications for Use SonaStar® Indicated for use in the fragmentation, emulsification and aspiration of both soft and hard (i.e. bone) tissue in the following surgical specialties:
Neurosurgery Gastrointestinal and Affiliated Organ Surgery Urological Surgery Plastic and Reconstructive Surgery General Surgery Orthopedic Surgery Gynecological Surgery except as contraindicated for uterine fibroids. Thoracic Surgery Laparoscopic Surgery Thoracoscopic Surgery
The system may also be combined with electrosurgery using optional RF surgery interface components.
2.2. Contraindications 2.2.1 The neXus Ultrasonic Surgical Aspirator System probe tips are not indicated for and should not be used for direct contact with cardiac tissue (direct cardiac application). 2.2.2 The irrigation pump is not indicated for and should not be used for the administration of parenteral fluids, infusion of drugs, or for any life sustaining purposes. 2.2.3 This neXus Ultrasonic Surgical Aspirator System device is not indicated for and should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids.
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3.
Adverse Effects WARNING
The neXus Ultrasonic Surgical Aspirator System and its accessories may emit harmful acoustic pressure if exposure exceeds recommended limits.
Limits For Airborne Acoustic Exposure Distance from operator’s or patient’s ear
Maximum Exposure Period Within a 24-hour period
12”
30 cm
Not to exceed 9 minutes
24”
60 cm
Not to exceed 90 minutes
> 24” > 60 cm Table 3.1: Limits for Airborne Acoustic Exposure
Not to exceed 240 minutes
WARNING
Tip and irrigation temperatures may exceed the tissue necrosis point if insufficient irrigation flow rates are used. For hard tissue removal, set the irrigation flowrate to a setting no less than the comparable vibration setting. For example, if the vibration setting is 70, a minimum flow setting of 70 should be used. Additional external irrigation, e.g. by administering sterile saline with a syringe over the distal tip portion, may be necessary for removal of very dense, hard osseous structures.
WARNING
Tissue necrosis may result if tip is not moved relative to tissue. A continuous, lateral sweeping motion is recommended in order to minimize contact duration with the ultrasonic tip and minimize heat build-up. When lateral motion is not possible withdraw and re-insert tip frequently.
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4.
Handpiece Assembly and Disassembly The handpiece assembly in the sterile field should be performed by trained and authorized OR staff only. Once the handpiece has been assembled, refer to the neXus Console Instructions For Use for connectivity with the system. The SonaStar handpiece is available in two different configurations (short or long) that can be connected to a variety of probes for different applications. The tip choice is determined by the type of tissue being targeted and at the discretion of the user. CAUTION
The sterile wire stylet, torque wrench and torque fixture should be retained with the handpiece in the sterile field.
CAUTION
All reusable system components like handpiece, torque fixture and torque wrench are supplied industrially cleaned, but NON-STERILE. All items intended for use in the sterile field must be cleaned and sterilized as per the indicated instructions before first clinical use and before every subsequent clinical use.
CAUTION
All items intended for use in the sterile field must be cleaned and sterilized as per indicated instructions in Chapter 5Error! Reference source not found. before each clinical use.
CAUTION
Do not attempt to tighten or loosen handpiece components by holding the handpiece case. Always place the handpiece into the torque fixture and use the torque wrench when tightening or untightening the tip. Do not over-tighten the tip.
CAUTION
All items intended for use in the sterile field must be cleaned and sterilized as per indicated instructions in Chapter 5Error! Reference source not found. before each clinical use.
CAUTION
The disposable items are intended for one procedure only (single use). Do not attempt to reuse or resterilize.
WARNING
Use only sterilization cycles specified in this user manual. Do not use any other sterilization cycles. Improper sterilization can lead to handpiece or accessory damage, patient injury, or death.
4.1. Items Required for Handpiece Assembly (Short & Long)
SonaStar Handpiece (Short or Long) SonaStar Sterilization Tray SonaStar Counter Wrench SonaStar Torque Wrench Desired Procedure Pack Monopolar Handpiece Cable (if needed)
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4.2. Handpiece Inspection (Short & Long) Handpiece Inspection: Perform Inspection Prior To Use Inspect Handpiece
Inspect the handpiece housing and cable for any visual cracks. Inspect the front metallic portion for surface damage like nicks, gouges and cracks. Inspect the threads for signs of damage or excessive wear. Replace if damaged.
Inspect Mating Surface
Inspect mating face of handpiece and ultrasonic tip to verify that it is clean and dry.
Table 4.1: Handpiece inspection
4.3. SonaStar Long Handpiece Assembly Handpiece Assembly – SonaStar Long Handpiece 1. Install the tip
Insert the tip into the handpiece and hand tighten turning clockwise. 2. Place handpiece into torque fixture
Place hand over torque fixture and hold handpiece securely down in torque fixture to tighten ultrasonic tip. Handpiece cable should be facing upward
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3. Tighten the ultrasonic tip
Slide torque wrench over tip, ensuring that text “Handpiece this side” faces the handpiece
Rotate clockwise until two clicks are heard. Remove wrench.
4. Install the Mid-Housing
Slide the Front Housing onto the handpiece and then tighten by turning clockwise. 5. Mount silicone elbow
Snap silicone elbow onto Mid-Housing and align with notch on silicone elbow 6. Replace O-ring (if required)
Slide the small O-ring over the probe and into the groove of the front driver. Replacement of this O-ring is not required for each use. Replace only if O-ring becomes worn or damaged. Medical grade silicone lubricant may be used to lubricate this O-ring.
7. Assemble housing tip assembly Screw together the inner and outer sleeves 8. Install the rigid housing tip assembly Push the rigid tip assembly onto the silicone elbow until the silicone elbow makes contact with the shoulder of the rigid Housing tip assembly. 9. Install the silicone sleeve Install the silicone sleeve (from the procedure tray) onto the rigid housing tip assembly.
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10. Attach the silicone tubing and O-ring
` Attach the smaller diameter tubing to the aspiration port on the front housing. Attach the larger diameter tubing to the blue connector on the rear of the handpiece. Slide the black O-ring over the handpiece up to the mid-section to secure the tubing.
Table 4.2: SonaStar Long Handpiece Assembly
The SonaStar Long Handpiece is now ready for use and can be connected to the SonaStar System. Refer to the neXus Console Instructions For Use for connectivity with system.
Figure 4.1: Fully assembled SonaStar Long Handpiece
4.4. SonaStar Short Handpiece Assembly Handpiece Assembly – SonaStar Short Handpiece 1. Install the tip
Insert the tip into the handpiece and hand tighten turning clockwise.
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2. Place handpiece into torque fixture Place hand over torque fixture and hold handpiece securely down in torque fixture to tighten ultrasonic tip.
Handpiece cable should be facing upward 3. Tighten the ultrasonic tip
Slide torque wrench over tip, ensuring that text “Handpiece this side” faces the handpiece Rotate clockwise until two clicks are heard. Remove wrench.
4. Install Front Housing
Slide the Front Housing onto the handpiece and then tighten by turning clockwise. Refer to the disposable procedure pack for information on which Font Housing (Short or Long) should be used for the selected procedure pack. 5. Install the silicone sleeve
Install the silicone sleeve from the procedure pack onto the rigid housing tip assembly.
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6. Attach the silicone tubing and O-ring
Attach the small diameter tubing to the aspiration port on the front housing. Attach the larger diameter tubing to the blue connector on the rear of the handpiece. Slide the black O-ring over the handpiece up to the mid-section to secure the tubing. Table 4.3: SonaStar Short Handpiece assembly The SonaStar Short Handpiece is now ready for use and can be connected to the SonaStar System. Refer to the neXus Console Instructions For Use for connectivity with system.
Figure 4.2: Fully assembled SonaStar Short Handpiece
4.5. Monopolar Guidelines When using the electrosurgical generator in combination with the neXus System for monopolar electrocautery, refer to the electrosurgical generator user manual for detailed indications for use, modes of operation, instructions for use, contraindications, electrosurgical guidelines, cautions, warnings When interfacing the neXus System with the electrosurgical generator, users should refer to the following warnings and cautions.
WARNING
The neXus Long or Short Handpieces can deliver RF energy via its attached probe tip when connected to a 3rd party electrosurgical generator using the RF Monopolar Handswitch Cable accessory. Misonix recommends use of the electrosurgical generators listed in Table 4.5 that have been validated for compatibility with the neXus system.
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CAUTION
The neXus system has been designed for use with an IEC60601-1 and IEC60601-2-2 compliant electrosurgical generators in the monopolar coagulation mode (COAG) only. Cut mode (CUT) cannot be activated when using the Misonix monopolar cable.
WARNING
DO NOT use any electrosurgical device that exceeds a peak electrosurgical output of 4.5KV in the coagulation mode (COAG) to avoid electrical shock.
CAUTION
Misonix recommends staying within the limits prescribed by the electrosurgical generator’s user manual for the type of procedure being performed, up to a maximum power setting of 70 W. Generally, the lowest setting that proves effective for the procedure being performed should be used to avoid arching.
CAUTION
Studies have shown that smoke generated during electrosurgical procedures can be potentially harmful to patients and the surgical team. These studies recommend adequately ventilating the smoke by using a surgical smoke evacuator or other means. Refer to the 3rd party electrosurgical generators user manual for more information regarding the evacuation of smoke.
WARNING
Improper connection of the RF monopolar fingerswitch cable may present a shock hazard. always use gloved, dry hands when plugging it in to the electrosurgical generator and handpiece.
WARNING
Always place the neXus SonaStar handpiece with the monopolar handpiece cable attached on a nonconductive surface when not in use for monopolar cautery.
WARNING
Always use the lowest possible generator setting that will achieve the desired cauterization effect. When higher than necessary voltages are used, the potential for arching are increased.
WARNING
Clean the neXus SonaStar tip frequently when using the tip for electrocautery. As eschar builds up on the tip, electrical impedance increases, and this can cause arching, sparking or ignition and flaming of the eschar. Clean with a nonabrasive sterile pad to prevent scratching of the probe tip. Scratch groves will increase eschar build up and can effect ultrasonic surgical performance of the tip.
WARNING
Do not wrap the neXus monopolar cable around metal instruments with sharp corners or features that can damage the cable and cause leakage current.
WARNING
Interference produced by the operation of recommended electrosurgical systems may adversely influence the operation of other electronic equipment.
WARNING
Use the neXus monopolar interface cable with caution in the presence of internal or external pacemakers or other active implanted devices. Interference produced by the recommended electrosurgical systems can cause a pacemaker or other active implantable device to malfunction, enter an unsafe mode, or cause permanent damage to the device. Consult the pacemaker manufacturer or responsible hospital department for qualified advice when using the neXus monopolar interface cable for electrocautery in patients with external or internal pacemakers or active implantable medical devices.
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The neXus Long or Short Handpieces can deliver RF energy via its attached probe tip when connected to a 3rd party electrosurgical generator using the RF Monopolar Handswitch Cable accessory. Misonix recommends use of the electrosurgical generators listed in Table 4.5 that have been validated for compatibility with the neXus system.
RECOMMENDED/COMPATIBLE ELECTROSURGICAL SYSTEMS MAKE
MODEL
Valleylab FT10
VLFT10GEN
Force2 /Force FX
FORCE FX-C
ForceTriad
ForceTriad
System 5000
60-8005-SYS
VIO-300 D
10140-100
Table 4.5
The RF energy is delivered via a sterile, single use RF Monopolar Handswitch Cable accessory that contains a hand switch that is used to facilitate the energization of the RF output. With the use of the sterile, single use RF Monopolar Handswitch Cable accessory, the neXus system can interface with 3rd party electrosurgical systems to provide monopolar electrocautery directly through the titanium probe tip thus enabling the surgeon to cauterize bleeding vessels without having to change instruments. The monopolar accessory cable contains a hand switch that is used to facilitate the energization of the RF output. The diagram below shows how to connect the neXus Long or Short Handpieces to the 3rd party electrosurgical system. All user settings for the 3rd party electrosurgical system are independently set using its user interface. The neXus console/generator does not control any of the operational parameters of the 3rd party electrosurgical system. Although electrosurgical devices support bipolar and monopolar instruments, as well as CUT and COAG modes, the Misonix single use monopolar cable is designed for use in monopolar COAG mode only. CUT mode cannot be activated when using the Misonix monopolar cable.
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CAUTION
The neXus system has been designed for use with an IEC60601-1 and IEC60601-2-2 compliant electrosurgical generators in the monopolar coagulation mode only. Cut mode cannot be activated when using the neXus Monopolar Handswitch Cable.
The items needed for interfacing a Sonastar handpiece with an RF electrosurgical device are listed below (see section 4.6 and 4.9 for assembly and disassembly): REF Number 100-29-0000
Description Single Use Monopolar Hand switch cable
QTY 1
4.6. Electrosurgery Handswitch Assembly The electrosurgery connector is located on the rear cap of the handpiece, adjacent to the cable strain relief. For electrosurgery capability, plug the appropriate end of the Single-Use Monopolar Handswitch Cable into the handpiece end, as shown in below. The Single-Use Monopolar Handswitch Cable can be used with BOTH the SonaStar Short Handpiece and the SonaStar Long Handpiece.
WARNING
Improper assembly of Single-Use Monopolar Handswitch Cable to endcap can expose potentially dangerous electrosurgery voltage. To avoid poor electrical connection, always make sure the Single-Use Monopolar Handpiece Cable socket is firmly and fully engaged onto the pin in the endcap. Inspect the silicone sleeve near the probe tip for cracks that may expose the probe (active electrode).
WARNING
Ensure that the aspiration tubing is fully seated onto the Aspiration Port in the base of the handpiece.
WARNING
Prior to and during use, inspect the Monopolar Handswitch Cable for possible damage (i.e. cracks in cable jacket).
CAUTION
Monopolar Handswitch Cable is supplied sterile and is NOT sterilizable.
CAUTION
Position Monopolar cable to avoid contact with the patient or any other leads.
CAUTION
After use with electrosurgical device, store unused handpiece probe tip in a location isolated from the patient.
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