Handpiece Instructions for Use
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Page 1
Standard Handpiece Instructions for Use
For additional information not contained in this manual, please visit ww.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 ensure 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 -
-
Caution: United States Federal law restricts this device to sale by or on the order of a physician or health care practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device; Not applicable in the European Union. The neXus® Ultrasonic Surgical Aspirator System is to be used by an appropriately trained and licensed healthcare practitioner. All health care institution personnel are to be trained in the healthcare institution’s procedures for universal precautions for bloodborne pathogens and the use of appropriate PPE.
1.1 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, LLC. 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
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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 ensure 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 Standard Handpiece with BoneScalpel or SonicOne OR 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.
Immediately suspend operation if Electrical Fault appears on display and/or an Electrical Fault audible indicator sounds. Remove ultrasonic tip from surgical site. Turn Mains Power OFF. Do not touch any metallic parts of handpiece, extension, ultrasonic tip or generator while fault is indicated.
Improper connection of the handpiece cable may present a shock hazard. Confirm that handpiece
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connector is dry prior to plugging it in.
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 health care institution 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.
All Misonix reusable items must be sterilized by moist heat (steam sterilization/autoclaved) after manual cleaning.
Automated cleaning-disinfection is not the final step prior to use. All Misonix reusable items must be sterilized by moist heat (autoclaved) after automated cleaning and disinfection.
Misonix LLC has validated all cleaning and sterilization cycles given in this manual. To prevent transmission of disease or malfunction of the neXus® system, Misonix recommends that the procedures given in this manual for cleaning and sterilizing the neXus® Ultrasonic Surgical Aspirator System and related accessories be followed. However, other end-user validated cleaning agents, cleaning procedures, and/or sterilization cycles may be used. 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 procedures as outlined in this manual in accordance with applicable local laws and regulations on cleaning and sterilization of reusable medical devices in the healthcare environment.
For all sterilization protocols listed below, always ensure the tethered cap is placed securely on the cable connector to protect the connector during sterilization.
The disposable items are intended for one procedure only (single use). Do not attempt to reuse or resterilize.
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
o o
Caution: United States Federal law restricts this device to sale by or on the order of a physician or health care practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device; Not applicable in the European Union. The neXus® Ultrasonic Surgical Aspirator System is to be used by an appropriately trained and licensed healthcare practitioner. All health care institution personnel are to be trained in the healthcare institution’s procedures for universal precautions for bloodborne pathogens and the use of appropriate 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.
The console should not be used adjacent to or stacked with other electrical equipment. If adjacent or stacked use is necessary, the console should be observed to verify normal operation in the configuration in which it will be used.
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 Standard 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 hardtissue. 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.
Be certain to clear debris from all internal passages by brushing. Failure to do so may hinder sterilization of units during autoclaving. Refer to the Pre-cleaning step below.
Do not immerse the ultrasonic handpiece or the handpiece cable. These items are not sealed against liquids and damage to equipment will result.
Use softened, filtered, or deionized water for diluting cleaning agents and for the final equipment rinse. Deionized water is recommended for the final rinse, if available. Mineral residues from hard water in the final rinse step can cause water stains and/or affect cleaning and disinfection.
The tethered handpiece cable cap should be placed on the handpiece cable connector immediately after the cable is disconnected from the console to prevent damage to the connector pins and remain on during precleaning, manual cleaning, automated cleaning/disinfection, and sterilization procedures.
Misonix does not recommend “FLASH” sterilization. Misonix has not validated “FLASH” sterilization.
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Poor steam quality may impair the sterilization process. For this reason, various norms (European standard EN 285 and the United States standard ANSI/AAMI ST79) recommend maximum impurity levels for steam feed water of autoclaves and sterilizer used in the medical field. Misonix recommends using water of a quality that conforms to the norms, the health care institution validated specifications for water quality, or otherwise using deionized water to generate steam for moist heat sterilization.
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.
Do not immerse ultrasonic console, handpiece, irrigation pump, remote footswitch, 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.
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.
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1.4 Trademark Information
Misonix®, neXus®, BoneScalpel® and SonicOne® are registered trademarks of Misonix, LLC., Farmingdale, NY
ASP Enzol® and Prolystica® are registered trademarks of STERIS Corporation, Mentor OH
1.5 Symbol Definition Chart Misonix CE number
Contains DEHP and/or Phthalates
Caution: Consult accompanying documents Caution: United States Federal law restricts this device to sale by or on the order of a physician or health care practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device; Not applicable in the European Union. Manufacturer
Date of Manufacture
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
Unique Device Identification is specific to a manufacturer and a device
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Identifies product as a medical device
Single sterile barrier system Restricted to sale by or on the order of a physician only
Non-sterile medical device
Do not use if package is damaged Contents are latex-free
Single use (do not re-use)
Do not re-sterilize
Table 1.2 Symbol Definitions
1.6 List of Accessories Probe Part Number 110-31-1110 110-31-1120 110-31-1121 110-31-1125 110-31-1210 110-31-1220 110-31-1230 110-31-2110 110-31-2120 110-31-2210 110-31-5501 120-31-10R1 120-31-10X1 120-31-13C2 120-31-13C3 120-31-13X2
Probe Description 10mm, Blunt Blade and Tubeset 20mm, Blunt Blade and Tubeset 20mm, Unilateral Serrated Blade and Tubeset 25mm, Blunt Blade and Tubeset Micro Hook Shaver and Tubeset Macro Hook Shaver and Tubeset Diamond Shaver and Tubeset 10mm MIS, Blunt Blade, Sheath and Tubeset 20mm MIS, Blunt Blade, Sheath and Tubeset Micro Hook Long Curved, Shaver, Sheath, and Tubeset Standard Decompression Kit (20mm blade, micro hook shaver and Tubeset) Cylindrical Probe and Tubeset Hatched Probe and Tubeset SharpVac and Tubeset Curette Tip Excel Kit SonicVac and Tubeset
Instructions For Use | neXus® Standard Handpiece 100-21-1000 rev D March 2023
EEU Device Class Class llb Class llb Class llb Class llb Class llb Class llb Class llb Class llb Class llb Class llb Class llb Class llb Class llb Class llb Class llb Class llb
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2. Indications and Contra Indications 2.1.
Indications
The Misonix LLC. neXus® Standard Handpiece is intended for use in the fragmentation, emulsification, and aspiration of both soft and hard (i.e., bone) tissue. The indications for use for the Standard Handpiece in combination with BoneScalpel and SonicOne OR probe kit accessory configurations and the indications are charted below. NEXUS INDICATIONS FOR USE BY HANDPIECE AND PROBE KIT ACCESSORY COMBINATION Standard Handpiece for use with BoneScalpel® and Sonic One® Indications for Use Indications for Use BoneScalpel ® SonicOne ® Indicated for use in the fragmentation and aspiration of soft and hard (e.g.: bone) tissue in the following surgical specialties:
Indicated for use in the fragmentation and aspiration of soft and hard tissue (i.e., bone) in the following surgical specialty:
Neurosurgery Gastrointestinal and Affiliated Organ Surgery Urological Surgery Plastic and Reconstructive Surgery General Surgery Orthopedic Surgery Gynecology External genitalia - condyloma - benign tumors (lipomas, fibromas, and leiomyomas) malignant primary and metastatic tumors of all types and the following cystic lesions: Bartholin's cysts, Vestibular adenitis, Inclusion cysts, Sebaceous cysts Abdominal area - any abnormal growth, cystic or solid, benign, or malignant, involving the ovary, fallopian tube, uterus, or the supporting structures of the uterus except as contraindicated for uterine fibroids. Thoracic Surgery Limited pulmonary reception such as segmetectomies, nonanatomical subsegmentectomies and metastatectomies. Wound Care The neXus Ultrasonic Surgical Aspirator is also indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement.
Wound Care The neXus Ultrasonic Surgical Aspirator is also indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement. Plastic and Reconstructive Surgery
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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.
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
3” - 24”
8 cm – 60 cm
28 minutes
> 24”
> 60 cm
287 minutes
Table 3.1: Limits for Airborne Acoustic Exposure
CAUTION
When using the SonicOne® OR Wide Hatch Probe (120-31-13X2) ensure patients less than 50” (127 cm) tall wear hearing personal protection devices (Hearing PPE) during debridement.
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 Handpiece assembly in the sterile field should be performed by trained and authorized OR staff only. Once the handpiece has been assembled, refer to neXus Console Instructions For Use for connectivity with system.
4.1.
CAUTION
Ensure all connections and mating surfaces of handpiece, extension and ultrasonic tip are clean and dry before assembly.
CAUTION
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 health care institution protocol for biohazardous waste. Tips are to be disposed of in a biohazardous sharps container.
CAUTION
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.
CAUTION
The handpiece must be placed into the counter wrench. Do not attempt to tighten or untighten 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.
CAUTION
Always tighten or un-tighten the probe cover by hand and without using any wrenches. Do not over-tighten the probe cover.
CAUTION
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.
Items Required for Handpiece Assembly Part # 100-21-0001 100-21-0002 100-21-0003 100-60-0000 100-61-0000 100-70-0000
Description Standard Handpiece Front Housing (BoneScalpel) Front Housing (SonicOne) Standard Handpiece Counter Wrench Standard Handpiece T-wrench Standard Sterilization Tray
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4.2.
Handpiece Inspection (prior to assembly) Perform an inspection of handpiece and all components prior to assembly. Handpiece Inspection Inspect Handpiece
Inspect the handpiece housing and front cover for damage and signs of wear such as scratches, cracks, and chips.
Inspect the handpiece cable to ensure it is not cut or frayed.
Inspect the handpiece cable connector, connector pins, and the tethered cap to ensure they are not damaged.
Place the tethered cap on the connector after inspection and leave in place until connection to the generator.
Do not use damaged handpieces or handpiece components. Contact Misonix Customer Service if damage is noted.
The neXus handpiece should be fully inspected for loose or missing components and tested for proper operation prior to each procedure.
Inspect Mating Surface Inspect mating face of handpiece to verify that it is clean and dry. Table 4.1 Handpiece Inspection
4.3.
Standard Handpiece Assembly Once the handpiece inspection is complete, the handpiece can be assembled in conjunction with the corresponding procedure pack (i.e., 110-31-1B10) Instructions For Use (included in the sterile packaged product).
1.
Insert handpiece in Counter Wrench, refer to procedure pack (i.e., 110-311B10) Instructions For Use for installation and tightening instructions.
2.
Install and tighten desired probe, refer to procedure pack (i.e., 110-31-1B10) Instructions For Use assembly for installation and tightening instructions.
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3.
Install and tighten appropriate Front Housing, refer to procedure pack (i.e., 110-31-1B10) Instructions For Use for installation and tightening instructions.
4.
Install appropriate sleeve, refer to procedure pack (i.e., 110-31-1B10) Instructions For Use for installation instructions.
5.
Connect tubing (irrigation / aspiration), refer to procedure pack (i.e., 110-311B10) Instructions For Use for installation instructions.
Table 4.2 Irrigation Tube Disassembly
The handpiece is now ready for use and can be connected to the neXus Console, refer to the neXus Console Instructions For Use (IFU) for additional instructions and information.
4.4.
Standard Handpiece Disassembly Note: After disconnection of the cable connector from the generator, place the tethered cap onto the cable connector. Leave the cable connector on during cleaning, disinfection, and sterilization. 1.
Disconnect tubing (irrigation / aspiration), refer to procedure pack (i.e., 110-31-1B10) Instructions For Use for installation instructions.
2.
Remove sleeve, refer to procedure pack (i.e., 110-311B10) Instructions For Use for installation instructions.
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3.
Remove Front Housing, refer to procedure pack (i.e., 110-31-1B10) Instructions For Use for installation and tightening instructions.
4.
Insert handpiece in Counter Wrench, refer to procedure pack (i.e., 110-311B10) Instructions For Use for installation and tightening instructions.
5.
Remove probe, refer to procedure pack (i.e., 110-311B10) Instructions For Use assembly for installation and tightening instructions.
Table 4.2 Irrigation Tube Disassembly CAUTION
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.
CAUTION
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 health care institution protocol for biohazardous waste. Tips are to be disposed of in a biohazardous sharps container.
WARNING
Remove probe cover, ultrasonic tip, and extension from the handpiece prior to cleaning and/or sterilization; otherwise, proper cleaning/sterilization may be inhibited.
CAUTION
The handpiece must be placed into the counter wrench. Do not attempt to tighten or untighten 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.
CAUTION
Always tighten or un-tighten the probe cover by hand and without using any wrenches. Do not over-tighten the probe cover.
CAUTION
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.
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5. Cleaning and Sterilization 5.1.
Dispose of Single-Use Items
WARNING:
Follow the health care institutions protocol for Universal Precautions for Blood Borne Pathogens including the use of Personal Protective Equipment (PPE) when cleaning and disinfecting reusable items after a clinical procedure.
WARNING
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 health care institution protocol for biohazardous waste. Tips are to be disposed of in a biohazardous sharps container.
WARNING
The disposable items are intended for one procedure only (single use). Do not attempt to reuse or resterilize.
All items marked single use must not be reused. Reuse of these items could result in severe patient injury or death. Once used, dispose of single use items in accordance with standard health care institution procedures for disposal of biohazardous waste.
The following items are considered reusable items and should be cleaned as recommended:
Part # 100-21-0001 100-21-0002 100-21-0003 100-60-0000 100-61-0000 100-70-0000
Description Standard Handpiece Front Housing (BoneScalpel) Front Housing (SonicOne) Standard Handpiece Counter Wrench Standard Handpiece T-wrench Standard Sterilization Tray
Misonix LLC. has validated the cleaning procedures outlined below. Misonix continually updates its sterilization and cleaning instructions as required. For the latest instructions and reuse recommendations please contact your local Misonix representative. WARNING
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 transmission of disease.
WARNING
Misonix LLC. has validated all cleaning and sterilization cycles given in this manual. To prevent transmission of disease or malfunction of the neXus® system, Misonix recommends that the procedures given in this manual for cleaning and sterilizing the neXus® Ultrasonic Surgical Aspirator System and related accessories be followed. However, other end-user validated cleaning agents, cleaning procedures, and/or sterilization cycles may be used. 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 procedures as outlined in this manual in accordance with applicable local laws and regulations on cleaning and sterilization of reusable medical devices in the healthcare environment.
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5.2. Point of Use Cleaning
5.3.
Point of Use Cleaning Following use, flush the handpiece lumen with a minimum of 100ml of saline to clear the bore of biological debris. Then remove visible blood and biological debris from the surface of the handpiece and components. Misonix recommends the use of CaviWipes® or equivalent quaternary ammonium compound surface disinfectant wipes to remove visible blood and biological debris from the surface of the handpiece and components. Please follow manufacturer’s instructions for surface cleaning and disinfection of hard nonporous surfaces, including, without limitation, following the instructions for the use of personal Protection Equipment (PPE) for blood borne Pathogens. Dispose of the used wipes in accordance with the health care institution protocol and local regulations regarding the disposal of biological hazardous waste. Place the handpiece into a tray and transport to the health care institution decontamination processing area. CAUTION: To avoid drying of biological soil: Transport the neXus Standard Handpiece to the decontamination processing area as soon as practical after the clinical procedure for cleaning. If transport to the decontamination processing area is delayed, cover the tray with a water dampened cloth or spray the tray and its contents with a pre-cleaning foam. The pre-water dampened cloth or cleaning foam will minimize the drying of biological soil and facilitate later decontamination processing. Transport the neXus Standard Handpiece to the decontamination area as soon as practical. CAUTION: DO NOT use saline to wet the tray and tray contents before transport to the decontamination processing area. CAUTION: DO NOT mix other heavy devices with the neXus Standard Handpiece during transportation to avoid damage to the handpiece.
Manual Cleaning/Washing Procedure Standard Handpiece Probe Covers and Wrenches
General Cautions and Notes.
Wash & Brush
WARNING: All Misonix reusable items must be sterilized by moist heat (steam sterilization/autoclaved) after manual cleaning. WARNING: Follow the health care institutions protocol for Universal Precautions for Blood Borne Pathogens including the use of Personal Protective Equipment (PPE) when cleaning and disinfecting reusable items after a clinical procedure. CAUTION: Do not use ultrasonic cleaners to clean the handpiece as this method could damage the handpiece. CAUTION: Be certain to clear debris from all internal passages by brushing. Failure to do so may hinder sterilization of units during autoclaving. Refer to the Pre-cleaning step below. CAUTION: Do not immerse the ultrasonic handpiece or the handpiece cable. These items are not sealed against liquids and damage to equipment will result. WATER QUALITY CAUTION: Use softened, filtered, or deionized water for diluting cleaning agents and for the final equipment rinse. Deionized water is recommended for the final rinse, if available. Mineral residues from hard water in the final rinse step can cause water stains and/or affect cleaning and disinfection. Disassemble the handpiece. Refer to Section 4.4. Prepare the alkaline enzymatic cleaning solution. o Misonix has validated and recommends the use of ASP Enzol® or Steris Prolystica® alkaline enzymatic detergents. Please follow manufacturer’s instructions preparation of the detergents, including, without limitation, the use of recommended Personal Protection Equipment (PPE).
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Misonix recommends following the health care institutions protocol for Universal Precautions for Blood Borne Pathogens including the use of Personal Protective Equipment when cleaning reusable items after a clinical procedure. Dispose of single use items in accordance with local regulations regarding the disposal of biological hazardous wipes. Thoroughly wet all surfaces of the handpiece covers and wrenches with an enzymatic detergent solution such as ASP Enzol® or Steris Prolystica® in accordance with the directions provided in the manufacturer’s Instructions for Use. Probe cover and wrenches may be fully immersed. Thoroughly wet a brush with warm cleaning solution. Brush all passages at least four (4) times from FRONT to REAR, rotating the brushes during insertion and inserting the brushes fully. This ensures clearing of debris from the internal passages. Attention should be given to hard to clean features such as crevices, channels, joints, or hard to reach areas where soil may be difficult to remove by brushing. Flush hard to reach areas using a sterile syringe filled with the enzymatic detergent in accordance with the directions provided in the manufacturer’s Instructions for Use. Item’s exterior surface can be cleaned using a standard soft bristle cleaning brush. Rinse item under warm running softened, filtered, or deionized water for a minimum of 1 minute to clear soap residue. Drain and then dry item fully with lint-free cloth, paper, or with medical-grade compressed air, 20 PSI (1.4 atm). Dispose of lint-free cloth or paper in accordance with Health care institution or Clinic practices for contaminated wastes. Inspect wrenches and remove any item which shows signs of damage (cracks, gouges, fractures etc.). Mark damaged items clearly to prevent future use before disposal. Inspect all items for cleanliness and damage following cleaning and prior to terminal sterilization. If soil remains, repeat the cleaning and rinsing procedure using fresh warm cleaning solution.
Rinse
Dry
Inspect
Post Cleaning
Table 5.1 Cleaning of Probe Cover and Wrenches
Standard Handpiece General Cautions and Notes.
Wipe Cable
WARNING: All Misonix reusable items must be sterilized by moist heat (autoclaved) after manual cleaning. WARNING: Follow the health care institutions protocol for Universal Precautions for Blood Borne Pathogens including the use of Personal Protective Equipment (PPE) when cleaning and disinfecting reusable items after a clinical procedure. CAUTION: Do not use ultrasonic cleaners to clean the handpiece as this method could damage the handpiece. CAUTION: Be certain to clear debris from all internal passages by brushing. Failure to do so may hinder sterilization of units during autoclaving. Refer to the Pre-cleaning step below. CAUTION: Do not immerse ultrasonic handpiece, handpiece cable. These items are not sealed against liquids and damage to equipment will result. WATER QUALITY CAUTION: Use softened, filtered, or deionized water for diluting cleaning agents and for the final rinse of equipment. Deionized water is recommended for the final rinse if available. Mineral residues from hard water in the final rinse step can cause water stains and/or affect cleaning and disinfection. TETHERED HANDPIECE CABLE CAP: CAUTION: The tethered handpiece cable cap should be placed on the handpiece cable connector immediately after the cable is disconnected from the console to prevent damage to the connector pins and remain on during precleaning, manual cleaning, automated cleaning/disinfection, and sterilization procedures. Misonix recommends the use of CaviWipes® or equivalent quaternary ammonium compound surface disinfectant wipes to remove visible blood and biological debris from the surface of the handpiece and components. Please follow manufacturer’s instructions for surface cleaning and disinfection of hard non-porous surfaces, including, without limitation, following the
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instructions for the use of personal Protection Equipment (PPE) for blood borne Pathogens. Dispose of the used wipes in accordance with local regulations regarding the disposal of biological hazardous waste. Misonix recommends the use of ASP Enzol® or Steris Prolystica® alkaline enzymatic detergents. Please follow manufacturer’s instructions preparation of the detergents, including, without limitation, the use of recommended Personal Protection Equipment (PPE). Misonix recommends following the health care institutions protocol for Universal Precautions for Blood Borne Pathogens including the use of Personal Protective Equipment when cleaning reusable items after a clinical procedure. Dispose of single use item in accordance with local regulations regarding the disposal of biological hazardous wipes.
Wash & Brush
Wash and brush the handpiece with an enzymatic detergent such as ASP Enzol® or Steris Prolystica® in accordance with the directions provided in the manufacturer’s Instructions for Use. The handpiece cannot be immersed. Brush all passages (lumen) at least four (4) times from FRONT to REAR, rotating the brushes during insertion and inserting the brushes fully. This ensures clearing of debris from the internal passages. The item’s exterior surface can be cleaned using a standard soft bristle cleaning brush. Rinse item under warm running water for a minimum of 1 minute to clear soap residue.
Rinse
Dry
Dry item fully with absorbent towel or paper. Dispose of cloth or paper in accordance with Health care institution or Clinic practices for contaminated wastes. Inspect handpiece and cable and remove any item which shows signs of damages (cracks, gouges, fractures etc.). Mark damaged items clearly to prevent future use before disposal. Inspect all items for cleanliness and damage following cleaning and prior to terminal sterilization. Inspect the handpiece housing and front cover for damage and signs of wear such as scratches, cracks, and chips. Inspect the handpiece cable to ensure it is not cut or frayed. Inspect the handpiece cable connector and the tethered connector cap to ensure they are not damaged. Do not use damaged handpieces or handpiece components. Contact Misonix Customer Service if damage is noted. The neXus handpiece should be fully inspected for loose or missing components and tested for proper operation prior to each procedure.
Inspect Post Cleaning
Table 5.2 Cleaning the Standard Handpiece
5.4.
Automated Cleaning/Washing Procedure Handpiece, Front Housing and Wrenches
General Cautions and Notes.
WARNING: Automated cleaning-disinfection is not the final step prior to use. All Misonix reusable items must be sterilized by moist heat (autoclaved) after automated cleaning and disinfection. WARNING: Follow the health care institutions protocol for Universal Precautions for Blood Borne Pathogens including the use of Personal Protective Equipment (PPE) when cleaning and disinfecting reusable items after a clinical procedure. CAUTION: Do not use ultrasonic cleaners to clean the handpiece as this method could damage the handpiece. CAUTION: Be certain to clear debris from all internal passages by brushing. Failure to do so may hinder sterilization of units during autoclaving. Refer to the Pre-cleaning step below. CAUTION: Do not immerse ultrasonic handpiece, handpiece cable. These items are not
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sealed against liquids and damage to equipment will result. WATER QUALITY CAUTION: Use softened, filtered, or deionized water for diluting cleaning agents and for the final rinse of equipment. Deionized water is recommended for the final rinse if available. Mineral residues from hard water in the final rinse step can cause water stains and/or affect cleaning and disinfection. WASHER-DISINFECTOR Note 1: Misonix recommends using a washer-disinfector designed and labeled for washing and disinfecting medical devices or meeting local regulations or regulatory standards and guidance. Note 2: For health care institutions and health care practitioners in the EEU, Misonix recommends the use of a washer-disinfector meeting the requirements of the ISO 15883 Washers- Disinfectors, Parts 1-5. TETHERED CAP: Caution: The cable tethered cap should be on the cable connector during precleaning and automated cleaning and disinfection procedures. The following should be performed on a disassembled handpiece: Pre-Cleaning Remove the probe and all housing components. Refer to Section 4.4 or instructions on disassembly of the handpiece and components. Prepare neodisher® MediClean forte in accordance with the directions provided in the manufacturer’s Instructions for Use. Use a tight-fitting brush dipped in the prepared cleaning solution to clean the lumen of the hand- piece by inserting the brush fully through the lumen until visible from the other side a minimum of four times, rotating the brush as it is inserted. Rinse all residual soap from the handpiece under warm running water for a minimum of one minute. Visually inspect internal and external surfaces of the handpiece including the pin cavity and repeat the above steps as required until all visible debris and staining are removed. Automated Wash When placing the handpiece into the automated washer, place on the top shelf of the washer. Attempt and Disinfection to align the lumen in the general direction of the water jet flow in the washer but at a slight angle to facilitate draining during the drying cycle.
Process the handpiece and all reusable components and accessories using the cycle parameters, in the table below. *Durations listed are minimums acceptable. Longer durations than those specified for cleaning and disinfection are acceptable. Post-Cleaning
Inspect all items for cleanliness and damage following cleaning and prior to terminal sterilization. Inspect the handpiece housing and front cover for damage and signs of wear such as scratches, cracks, and chips. Inspect the handpiece cable to ensure it is not cut or frayed. Inspect the handpiece cable connector and the tethered connector cap to ensure they are not damaged. Do not use damaged handpieces or handpiece components. Contact Misonix Customer Service if damage is noted. The neXus handpiece should be fully inspected for loose or missing components and tested for proper operation prior to each procedure.
Table 5.3 Cleaning of Handpiece, Front Housing, and Wrenches.
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Phase
Time*
Parameters
Detergent Type and Concentration
Pre-Wash 1
2 minutes
Cold tap or purified water
None
Wash 1
2 minutes
≥65.5°C (150°F)
neodisher® MediClean forte 2mL/L (¼ oz. / gallon)
Rinse 1
1 minute
Hot tap water
None
Disinfection
1 minute
≥90°C (194°F)
None
Drying
6 minutes
≥98.8 °C (210°F)
None
Table 5.4: Automated Wash Cycle Parameters (*Durations listed are minimum acceptable. Longer durations than those specified for cleaning and disinfection are acceptable.)
5.5.
Sterilizing by Steam Autoclave
Sterilization Methods and terminology are based on current editions of ANSI/AAMI ST81 and EN ISO 17664 standards. CAUTION:
For all sterilization protocols listed below, always ensure the tethered cap is placed securely on the cable connector to protect the connector during sterilization.
WARNING:
Follow the health care institution protocol for using a chemical or biological indicator with every sterilization load to ensure proper sterilization conditions of time, temperature, and saturated steam penetration.
WARNING:
Misonix LLC. has validated all cleaning and sterilization cycles given in this manual. To prevent transmission of disease or malfunction of the neXus® system, Misonix recommends that the procedures given in this manual for cleaning and sterilizing the neXus® Ultrasonic Surgical Aspirator System and related accessories be followed. However, other end-user validated cleaning agents, cleaning procedures, and/or sterilization cycles may be used. 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 procedures as outlined in this manual in accordance with applicable local laws and regulations on cleaning and sterilization of reusable medical devices in the healthcare environment.
CAUTION:
Misonix does not recommend “FLASH” sterilization. Misonix has not validated “FLASH” sterilization.
CAUTION:
Water Quality for Steam Generation: Poor steam quality may impair the sterilization process. For this reason, various norms (European standard EN 285 and the United States standard ANSI/AAMI ST79) recommend maximum impurity levels for steam feed water of autoclaves and sterilizer used in the medical field. Misonix recommends using water of a quality that conforms to the norms, the health care institution validated specifications for water quality, or otherwise using deionized water to generate steam for moist heat sterilization. Reusable, Autoclavable Components Misonix Part # Description 100-21-0000
Standard Handpiece
100-61-0000
T-Wrench
100-60-0000
Counter Wrench
100-21-0003
SonicOne Front Housing
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