SonicOne Instructions for Use Rev E PDF download

Instructions For Use SonicOne Clinic Powered by Misonix

Table of Contents 1.

2.

3. 4. 5.

6.

7.

8.

9.

10. 11. 12.

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General Safety Statements ... 3 3 1.1. EMC Statement ... 3 1.2. Electrical Safety Statement ... 7 1.3. Environmental Statement ... 8 1.4. Summary Of Safety Notices ... 8 1.5. Trademark Information ... 12 1.6. Explanation Of Symbols ... 13 Indications And Contra Indications... 14 2.1. Indications ... 14 2.2. Contra Indications ... 14 Adverse Effects ... 14 Considerations During Clinical Use ... 15 4.1. SonicOne CLINIC Use ... 15 System Overview ... 17 5.1. Principle Of Operation ... 17 5.2. Reusable System Components ... 18 5.3. Single Use, Sterile Components ... 19 Console ... 19 6.1. Receptacles, Controls And Indicators ... 19 6.2. Menu Functions ... 21 6.3. Main Functions... 23 6.4. Alerts And Indicators ... 25 System Set-Up ... 27 7.1. Installation ... 27 7.2. Console Set-up – Part I (Non-sterile) ... 29 7.3. Handpiece Assembly (Sterile) ... 29 7.4. Console Set-up – Part II (Non-sterile) ... 30 7.5. Perform System Check ... 32 Handpiece Assembly And Disassembly ... 32 8.1. Handpiece Assembly ... 32 8.2. Handpiece Disassembly ... 33 Cleaning And Sterilization... 34 9.1. Disassembly ... 34 9.2. Cleaning ... 35 9.3. Sterilizing By Steam Autoclave ... 38 9.4. Expected Life, Reusable Components ... 39 9.5. Deviations From Decontamination, Cleaning And Sterilization Instructions... 39 Troubleshooting ... 39 Specifications ... 42 Service, Repair And Technical Correspondence ... 43 12.1. Fuse Replacement ... 43 12.2. Pump Head Replacement ... 45 12.3. Repair, Service and Replacement Parts ... 46 12.4. Important Notice ... 47

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For additional information not contained in this manual, please visit www.misionix.com or contact your local sales representative.

1. General Safety Statements WARNING 1.1

The SonicOne CLINIC 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 1.2

The SonicOne CLINIC 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 1.1

Special Skills and Training Requirements 1. U.S. federal law restricts this device to sale by, or on the order of a licensed healthcare practitioner. 2. The SonicOne CLINIC system is to be used by an appropriately trained and licensed healthcare practitioner.

1.1. EMC Statement The SonicOne CLINIC system is designed and tested to comply with FCC regulations for conducted and radiated emissions under Part 18 Subchapter J. and to comply with IEC EN60601-1-2 guidelines for EMC.

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CAUTION 1.2

This device is considered medical electrical equipment. Medical electrical equipment needs special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in this operator’s manual.

WARNING 10.2

Portable and mobile RF communication equipment (including peripherals such as antennas) should be no closer than 30 cm (12 inches) to any part of the console, including the cables supplied with the console Otherwise degradation of the performance of this equipment could result.

WARNING 10.3

The use of accessories, transducers and cables other than those specified or provided by Misonix may result in increased electromagnetic emissions or decreased immunity of the device and may result in improper operation. Use only Misonix branded equipment and accessories.

WARNING 10.4

Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally

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Electromagnetic Compatibility Guidance (in accordance with UL/EN/IEC 60601-1) Guidance And Manufacturer’s Declaration – Electromagnetic Emissions (Table 201) The SonicOne CLINIC SYSTEM is intended for use in the electromagnetic environment specified below. The customer or the user of SonicOne CLINIC SYSTEM should ensure that it is used in such an environment. Emissions test RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions

Compliance

Electromagnetic environment – guidance

Group 1

The SonicOne CLINIC SYSTEM uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

Class A Class A

The SonicOne CLINIC SYSTEM is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Complies

IEC 61000-3-3 Table 1.1 Guidance & manufacturer’s declaration on electromagnetic emissions (EN table 201)

NOTE: The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). NOTE: The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals. If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.

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Guidance And Manufacturer’s Declaration – Electromagnetic Immunity (Table 202) The SonicOne CLINIC SYSTEM is intended for use in the electromagnetic environment specified below. The customer or the user of the SonicOne CLINIC SYSTEM should assure that it is used in such an environment. IEC 60601 test level

Immunity test

Compliance level

Electromagnetic environment – guidance

Electrostatic discharge (ESD) IEC 61000-4-2

o ±8 kV contact

o ±2kV, ±5kV, ±8kV,

Surge IEC 61000-4-5

o ±1 kV differential mode

o ±1 kV differential mode o ±2 kV common o ±2 kV common mode mode

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

<0 % UT (100 % dip in UT for 0,5 cycle

0 % UT (100 % dip in UT) for 0,5 cycle

70 % UT (30 % dip in UT) for 25 cycles

0 % UT (100 % dip in UT) for 1 cycles

Mains power quality should be that of a typical commercial or hospital environment. If the user of the SonicOne CLINIC SYSTEM requires continued operation during power mains interruptions, it is recommended that the powered from an uninterruptible power supply.

0 % UT (100 % dip in UT) for 5 sec

30 A/m

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

±15 kV air o ±15 kV air Electrical fast transient/ o ±0.5 kV, ±1 kV o ±0.5 kV, ±1 kV Mains power quality should be that of a burst line to line line to line typical commercial or hospital environment. IEC 61000-4-4 o ±0.5 kV, ±1 kV, ±2 kV o ±0.5 kV, ±1 kV, ±2 kV line to ground line to ground

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 NOTE

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

UT is the AC mains voltage prior to application of the test level.

Table 1.2 Guidance & manufacturer’s declaration on electromagnetic immunity (EN table 202)

List of Cables Item

Cable Length

Type

Handpiece cable

15 ft. | 4.6 m

shielded 2-conductor

Power cord

10 ft. | 3.0 m

unshielded 3-conducter

Footswitch cable

14 ft. | 4.3 m

shielded 2-conductor

Table 1.3 List of cables

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Guidance And Manufacturer’s Declaration – Electromagnetic Immunity (Table 204) The SonicOne CLINIC SYSTEM is intended for use in the electromagnetic environment specified below. The customer or the user of the SonicOne CLINIC SYSTEM should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment – guidance Portable and mobile RF communications equipment should be used no closer to any part of the SonicOne CLINIC SYSTEM, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

3 Vrms 150 kHz to 80 MHz

3 V/m 80 MHz to 2.7 GHz

3V

3 V/m

d = 1.2√P d = 1.2√P

80 MHz to 800 MHz

d = 2.3√P

800 MHz to 2.7 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the SonicOne CLINIC SYSTEM is used exceeds the applicable RF compliance level above, the SonicOne CLINIC SYSTEM should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the SonicOne CLINIC SYSTEM. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Table 1.4 Guidance & manufacturer’s declaration on electromagnetic immunity (EN table 204)

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Recommended Separation Distances Between Portable And Mobile RF Communications Equipment And The SonicOne CLINIC System (Table 206) The SonicOne CLINIC system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the SonicOne CLINIC System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SonicOne CLINIC system below, according to the maximum output power of the communications equipment. Rated maximum output Separation distance according to frequency of transmitter power m of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,7 GHz W d = 1.2√P d = 1.2√P d = 2.4√P 0.01

0.12

0.1

0.38

1

1.2

10

3.8

100

12

0.24 0.76 2.4 7.6 24

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Table 1.5 Recommended separation distances (EN table 206)

1.2. Electrical Safety Statement The SonicOne CLINIC system is designed and tested to comply with UL 60601-1 and EN 60601-1.

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WARNING 1.3

The SonicOne CLINIC system generates high voltages within the console itself and the connected handpiece. To avoid injury, the console should never be operated before ensuring that its cover is properly closed and not tampered with. Do not attempt to remove or disassemble the cover. There are no user-serviceable parts inside the console. All service should only be performed by an authorized Misonix representative. No modification of this equipment is required.

WARNING 1.4

Proper system grounding can only be ensured when an approved, hospital-grade receptacle and matching power cord are used. To avoid the risk of electric shock, this equipment must only be connected to a supply with protective earth. Install plug and receptacles as per local regulations before operating the unit. Power cord, plug and receptacle should be examined to verify that they are in good working condition before connecting the console. Never pull on the power cord to remove it from the receptacle.

WARNING 1.5

Connecting the console to a power outlet with inadequate voltage or frequency may cause the unit to malfunction or to create a shock or fire hazard. Confirm that the voltage selector switch on the console rear panel is set to the local voltage setting and ensure that the correct fuses are being used. Refer to section 12.1 on instructions for fuse replacement.

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1.3. Environmental Statement This equipment consists of materials that may be recycled if disassembled by a specialized company. Please observe local and federal regulations regarding the disposal of packing materials and old equipment.

Important Environmental Information for Users within the European Economic Area The European Parliament did enforce new regulations developed in 2005 concerning the disposal medical electrical and electronic equipment. The regulations, called Directives, place responsibilities on the supplier and you, the purchaser/user. One of the actions required is to inform users of their obligations. The device has been assessed in accordance with the European Parliament Directive 2002/96/EC on Waste Electrical and Electronic Equipment, usually referred to as WEEE Directive. The WEEE Directive requires that the device be disposed of at the end of its useful life in an environmentally responsible manner. Similar requirements have been applied to refrigerators for some time. The WEEE Directive requires that if replacing the device with a new equivalent product, that supplier shall collect the old item without cost to the user. If you wish to dispose of the device without replacing it then the device must not be mixed with unsorted municipal waste. The crossed-out wheeled bin symbol on the unit label or packaging, and repeated below, indicates this requirement.

Disposal Symbol, disposal to be compliant with EN 50419 You must ensure that the device is disposed of at an authorized treatment facility; details can be obtained from your local council. Table 1.3 Environmental statement

1.4. 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, Cautions and Notes 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.

NOTE

Indicates potential hazard that may result in product damage.

Table 1.4 Conventions on warnings, cautions and notes

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List Of Warnings WARNING 1.1

The SonicOne CLINIC 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 1.2

The SonicOne CLINIC 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.

WARNING 1.3

The SonicOne CLINIC system generates high voltages within the console itself and the connected handpiece. To avoid injury, the console should never be operated before ensuring that its cover is properly closed and not tampered with. Do not attempt to remove or disassemble the cover. There are no user-serviceable parts inside the console. All service should only be performed by an authorized Misonix representative. No modification of this equipment is required.

WARNING 1.4

Proper system grounding can only be ensured when an approved, hospital-grade receptacle and matching power cord are used. To avoid the risk of electric shock, this equipment must only be connected to a supply with protective earth. Install plug and receptacles as per local regulations before operating the unit. Power cord, plug and receptacle should be examined to verify that they are in good working condition before connecting the console. Never pull on the power cord to remove it from the receptacle.

WARNING 1.5

Connecting the console to the power outlet with inadequate voltage or frequency may cause the unit to malfunction or to create a shock or fire hazard. Confirm that the voltage selector switch on the console rear panel is set to the location voltage setting and ensure that the correct fuses are being used. Refer to section 12.1 on instructions for fuse replacement.

WARNING 1.6

Remove handpiece front housing and ultrasonic probe from the handpiece prior to cleaning and disinfection or sterilization; otherwise proper cleaning and disinfection or sterilization may be inhibited.

WARNING 3.1

Tip and irrigant 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 7, 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. The SonicOne CLINIC system and its accessories may emit harmful acoustic pressure if exposure exceeds recommended limits. Wear hearing protection or protect patient hearing if not within the exposure limits. For the Wide Hatch Probe: Less than 50” (127 cm) tall patients to wear ear protection during debridement. All other patients, to wear ear protection only for upper body debridement.

WARNING 3.2

WARNING 3.3

WARNING 3.4

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WARNING 4.1

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.

WARNING 4.2

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.

WARNING 4.3

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.

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WARNING 6.1

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.

WARNING 7.1

Improper connection of the handpiece cable may present a shock hazard. Confirm that handpiece connector is dry prior to plugging it in.

WARNING 7.2

Do not operate pump with pump cover in raised position. Rollers might pinch loose clothing or fingers. Personal injuries may result. Cooling of the ultrasonic tip and irrigation at the treatment site will be inhibited.

WARNING 7.3

Tip and irrigation temperatures may exceed the tissue necrosis point with SonicOne CLINIC accessories for hard tissue removal if insufficient irrigation flow rates are used. Always set the irrigation flowrate for hard tissue removal to a setting no less than the comparable vibration setting. For example, if the vibration setting is a 7, a minimum flow setting of 70% should be used.

WARNING 7.4

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.

WARNING 8.1

Remove probe cover, ultrasonic tip and extension from the handpiece prior to cleaning and/or sterilization; otherwise proper cleaning/sterilization may be inhibited.

WARNING 9.1

Single-use items should be discarded following each surgical procedure according to hospital protocol for disposal of bio contaminated wastes. Do not attempt to reuse or re-sterilize any single-use items Dispose ultrasonic tips in a sharps container.

WARNING 9.2

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.

WARNING 9.3

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 SonicOne CLINIC 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 procedures as outlined in this manual.

WARNING 9.4

The disposable items are intended for one procedure only (single use). Do not attempt to reuse or re-sterilize.

WARNING 10.1

If a Mains Power fuse fails after replacement when the unit is reactivated, discontinue use of the device and contact an authorized Misonix representative.

WARNING 10.2

Portable and mobile RF communication equipment (including peripherals such as antennas) should be no closer than 30 cm (12 inches) to any part of the console, including the cables supplied with the console Otherwise degradation of the performance of this equipment could result.

WARNING 10.3

The use of accessories, transducers and cables other than those specified or provided by Misonix may result in increased electromagnetic emissions or decreased immunity of the device and may result in improper operation. Use only Misonix branded equipment and accessories.

WARNING 10.4

Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

WARNING 12.1

Connecting the console to a power outlet with inadequate voltage or frequency may cause the unit to malfunction or to create a shock or fire hazard. Confirm that the voltage selector switch in the console rear is set to the local voltage setting and ensure that the correct fuses are being used. Refer to section 12 on fuse replacement.

WARNING 12.2

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 for servicing.

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List Of Cautions CAUTION 1.1

Special Skills Training Requirements 

Federal law restricts this device to sale by, or on the order of a licensed healthcare practitioner.



The SonicOne CLINIC system is to be used by an appropriately trained and licensed healthcare practitioner.

CAUTION 1.2

This device is considered medical electrical equipment. Medical electrical equipment needs special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in this operator’s manual.

CAUTION 1.3

Portable and mobile RF communication equipment can affect medical electrical equipment. If RF equipment is in use monitor the SonicOne Clinic for proper function during procedure.

CAUTION 1.4

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.

CAUTION 1.5

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.

CAUTION 1.6

Be certain to clear debris from all hollow passages of the probe and handpiece by manual brushing. Failure to do so may hinder disinfection of the units or sterilization of units during autoclaving.

CAUTION 1.7

Allow reusable, autoclavable items to gradually return to room temperature after steam sterilization and prior to usage.

CAUTION 3.1

The SonicOne Clinic system and its accessories may emit harmful acoustic pressure if exposure exceeds recommended limits.

CAUTION 4.1

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.

CAUTION 4.2

Insufficient irrigation and high tip pressure (loading) under extended exposure, e.g. in tight cavities, are to be avoided in SonicOne CLINIC hard tissue removal. It is recommended to withdraw and re-insert the ultrasonic tip repeatedly to re-establish adequate cooling and lubrication.

CAUTION 4.3

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 of the skull, when using the SonicOne CLINIC accessories.

CAUTION 7.1

All reusable system components like handpiece, probe covers, counter wrench, and 7/16th probe 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 7.2

All items intended for use in the sterile field must be cleaned and sterilized as per indicated instructions before each Clinical use.

CAUTION 7.3

The disposable items are intended for one procedure only (single use). Do not attempt to reuse or re-sterilize.

CAUTION 7.4

Do not place the soft silicone tube behind or in front of the rollers (latch removed in illustrations)

CAUTION 7.5

Do not pinch the soft silicone tube when the latch is locked.

CAUTION 7.6

Do not pinch barb fittings when closing the latch.

CAUTION 7.7

Prime the irrigation tubing prior to use. At all times ensure that the irrigant flows towards the handpiece when footswitch is depressed. If no irrigant is flowing, cease use until flow is restored.

CAUTION 7.8

The system check should always be done in advance of preparing patient for surgery to minimize risk to patient in case of system malfunction.

CAUTION 8.1

Ensure all connections and mating surfaces of handpiece, extension and ultrasonic tip are clean and dry before assembly.

CAUTION 9.1

Do not use ultrasonic cleaners to clean the handpiece as this method could damage handpiece.

CAUTION 9.2

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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CAUTION 9.3

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.

CAUTION 9.4

The handpiece needs to be examined for any visual cracks in the housing that could pose a hazard.

CAUTION 9.5

Single-use items should be discarded following each surgical procedure according to hospital protocol for disposal of biocontaminated wastes. Do not attempt to reuse or re-sterilize any single-use items.

CAUTION 9.6

The probes need to be examined after use for nicks, gouges, or wear that could have a negative impact upon ultrasonic performance or could lead to destruction of the instrument.

CAUTION 9.7

Do not use ultrasonic cleaners to clean the handpiece as both methods could damage handpiece.

CAUTION 12.1

Use only genuine replacement parts from Misonix. Use of parts furnished by other sources may result in patient or operator injury or system malfunction and will void any applicable warranty.

CAUTION 12.2

Before using loose packing materials, such as foam pellets, shredded paper or similar, be sure to wrap the component(s) separately in plastic bags, film or other protective wrapping.

Proceed to next page

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List Of Notes NOTE 4.1

After extended periods of operation, the bottom of the console housing may become warm to the touch. This is normal. Do not touch the bottom of the console housing while in operation or shortly after operation.

NOTE 4.2

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.

NOTE 4.3

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.

NOTE 7.1

Adequate air circulation is needed to cool electronic components inside of the unit. Do not block the cooling fan at the console rear or the air vents on the console bottom. Do not place the unit on a towel, foam or other soft surface since the material may block the air vents. Blocking these vents may cause unit to overheat and malfunction or create a shock hazard. A clear drape can be used to protect the console front panel but do not cover the pump housing or other console portions.

NOTE 8.1

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.

NOTE 8.2

Always tighten or un-tighten the probe cover by hand and without using any wrenches. Do not overtighten the probe cover.

NOTE 8.3

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 overtighten the tubing connector.

NOTE 9.1

Allow reusable, autoclavable items to gradually return to room temperature after steam sterilization and prior to usage.

NOTE 9.2

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.

1.5. Trademark Information Misonix® and SonicOne® are registered trademarks of Misonix, Inc., Farmingdale, NY ASP Enzol® and Prolystica® are registered trademarks of STERIS Corporation, Mentor, OH Steris® is a registered trademark of Steris Corporation Mentor, OH

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1.6. Explanation Of Symbols Console Related Symbols Symbol

Description

Symbol

Description

Symbol

Description

Enable / Standby Ultrasound

Caution: Dangerous voltage

Mains Power ON

Scroll through menu pages

Caution: Consult accompanying documents

Mains Power OFF

Amplitude setting

Caution: Pinch hazard

Protective earth ground

Pulse setting

Consult Instructions for Use

Equipotentiality connection

Flow setting

Type B equipment

Disposal to be compliant with EN 50419 (WEEE directive)

Do not reuse

Sterilized using Ethylene Oxide

Restricted to sale by or on the order of a physician only

Do not use if packaging is damaged

Sterilized using Gamma Irradiation

Authorized representative

Use by date indicated

Catalog number

Do not expose to temperatures greater than indicated

Lot or batch code

AC Voltage

Must use hospital grade power cord only

Fuse

Manufacturer

Misonix CE number

Classified by UL

Footswitch connector

Contents are latex-free

YYYY- MM-DD

Irrigation Source Contains DEHP and/or Phthalates Table 1.6 Explanation of symbols 14 E-SOUM-PLUS Rev E

Vacuum source

Warning: Hearing Protection

2. Indications And Contra Indications 2.1. Indications The SonicOne CLINIC® is Indicated for use in the fragmentation and aspiration of soft and hard (e.g.: bone) tissue in the following surgical specialties: • Neurosurgery • Gastrointestinal and Affiliated Organ Surgery • Urological Surgery • Plastic and Reconstructive Surgery • General Surgery • Orthopedic Surgery • Gynecology o External genitalia - condyloma - benign tumors (lipomas, fibromas, and leiomyoma) - malignant primary and metastatic tumors of all types and the following cystic lesions: Bartholin's cysts, Vestibular adenitis, Inclusion cysts, Sebaceous cysts o Abdominal area - any abnormal growth, cystic or solid, benign or malignant, involving the ovary, fallopian tube, uterus, or the supporting structures of the uterus. • Thoracic Surgery o Limited pulmonary reception such as segmetectomies, nonanatomical subsegmentectomies and metastatectomies. • Wound Care o The SonicOne CLINIC® 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. The SonicOne CLINIC system to be operated by medical professionals justified to practice in the fields covered by the stated indications for use. CAUTION 1.1

Special Skill and Training requirements. Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. The SonicOne CLINIC is to be used by an appropriately trained and licensed healthcare practitioner.

2.2. Contra Indications The SonicOne CLINIC ultrasonic surgical aspirator system is not indicated for and should not be used for cardiac surgery and any procedure in the proximity of the heart. 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. This SonicOne CLINIC ultrasonic surgical aspirator device is not indicated for and should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids.

3. Adverse Effects WARNING 3.1

Tip and irrigant 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 7, 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 3.2

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.

WARNING 3.3

The SonicOne CLINIC system and its accessories may emit harmful acoustic pressure if exposure exceeds recommended limits. Refer to the table below for limits for airborne acoustic exposure. Wear hearing protection or protect patient hearing if not within the exposure limits.

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WARNING 3.4

For the Wide Hatch Probe: Less than 50” (127 cm) tall patients to wear ear protection during debridement. All other patients are to wear ear protection only for upper body debridement.

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

4. Considerations During Clinical Use WARNING 4.1

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.

NOTE 4.1

After extended periods of operation, the bottom of the console housing may become warm to the touch. This is normal. Do not touch the bottom of the console housing while in operation or shortly after operation.

4.1. SonicOne CLINIC Use Recommended Settings The following settings are general guidelines and should be adjusted based on indication, anatomy, pathology and surgeon’s preference.

Amplitude

Pulse

Flow

Highest

10

100%

Very High

9

100%

90%

High

8

100%

80%

Standard (Default)

7

100%

70%

Moderate

6

100%

60%

Low

5

100%

50%

Table 4.1 Recommended settings • • •

A high amplitude setting results in more aggressive tissue removal, a low setting in less aggressive tissue removal. A higher amplitude setting in combination with lower irrigation could result in increased tissue necrosis. A lower amplitude setting in combination with higher irrigation would minimize or eliminate tissue necrosis. Lower pulse allows for resting periods inserted within the duty cycles Bone shaving tips tend to require a lower amplitude than cutting blades

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CAUTION 4.1

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.

Tip Limitations During Bone Removal The SonicOne Clinic reusable tips are used for soft tissue wound debridement. The SonicOne Clinic may be used with Misonix SonicOne OR or BoneScalpel sterile, single use disposable tips. BoneScalpel tips are used for bone cutting and bone shaving in cases where bone is involved in the wound. Some SonicOne OR tips offer a vacuum sheath for aspiration of irrigation fluid and reduction in spray. Contact your sales representative for assistance with ordering SonicOne OR or BoneScalpel tips for use with the SonicOne Clinic console and handpiece. Both the ultrasonic tip and the extension are vibrating at high frequency and are thus exposed to extreme mechanical stresses, especially when cutting bone. Note: When using Bonescalpel or SonicOne OR parts refer to their respective IFU’s for instruction on assembly and disassembly. WARNING 4.2

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.

WARNING 4.3

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.

CAUTION 4.2

Insufficient irrigation and high tip pressure (loading) under extended exposure, e.g. in tight cavities, are to be avoided in SonicOne CLINIC hard tissue removal. It is recommended to withdraw and re-insert the ultrasonic tip repeatedly to re-establish adequate cooling and lubrication.

CAUTION 4.3

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 of the skull, when using the SonicOne CLINIC accessories.

NOTE 4.2

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.

NOTE 4.3

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.

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5. System Overview 5.1. Principle Of Operation The SonicOne CLINIC system is designed to ultrasonically dissect and fragment soft and hard tissue. The system consists of an ultrasonic console with handpiece and accessories. The console features an integrated irrigation pump.

Figure 5.1 SonicOne Clinic Console.

Figure 5.2 SonicOne Clinic handpiece, probe cover and probe The console produces an electrical signal that is fed into the handpiece and its piezoelectric transducer. The transducer converts the electrical signal into mechanical vibrations. The vibratory motion is amplified all the way down to the tip’s distal end. Various tip shapes and sizes are available to achieve desired tissue effects. •

Wound Debridement Applications º

•

Debridement probes are typically used for contact wound debridement. Tissue excision and fragmentation are achieved through cavitation and other mechanical and hydrodynamic effects.

Applications: Specialized tips are utilized on hard tissue structures. º º º º

BoneScalpel blades, typically used for cutting bone, are usually flat and have a blunt active edge. A compression cut is achieved through repetitive impacts on the bone at an ultrasonic frequency. BoneScalpel shaving tips are used for sculpting bone. They have an abrasive surface for bone removal through abrasion under ultrasonic oscillation. SonicOne CLINIC multi-function tips can have a combination of blunt and abrasive cutting surfaces. SonicOne OR multi-function tips can have a combination of blunt and abrasive cutting surfaces and offer vacuum sheaths for irrigant aspiration and spray reduction. Note: When using Bonescalpel or SonicOne OR parts refer to their respective IFU’s for instruction on assembly and disassembly.

Warning

BoneScalpel blades and shavers and SonicOne OR probe tips are single-use items should be discarded following each surgical procedure according to hospital protocol for disposal of bio contaminated wastes. Do not attempt to reuse or re-sterilize any single-use items. Dispose ultrasonic tips in a sharps container.

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A peristaltic pump, integrated into the SonicOne CLINIC console, provides irrigant (sterile physiological saline) to the operative site during use.

5.2. Reusable System Components The following system components represent the minimum requirements for performing soft and hard tissue procedures. They can be ordered as a system or individually.

Required System Components E-SOP-GEN

Misonix console

Includes IV pole, power cord, footswitch, peristaltic pump and instructions for use

E-SOP-HP

SonicOne CLINIC handpiece

BCM-CW

Counter wrench for SonicOne CLINIC handpiece

E-PWRCH

7/16th“ Probe Wrench

BCM-SS

Probe Cover

BCM –H2

Soft Tissue Probe Cover

Table 5.2 Required system components Components and quantities included with the system may change over time, please check with your Misonix representative for the most current configuration.

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5.3. Autoclavable Debridement Probes Components and quantities included with the system may change over time, please check with your Misonix representative for the most current configuration. Ultrasonic probes are supplied NON Sterile and can be reused. At least one of the following probes must be available for each surgical procedure.

Table 5.3 Autoclavable Debridement Probes

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MISONIX

SonicOne System

SonicOne Instructions for Use Rev E