Misonix sonicone Clinic User manual

Instructions For Use
SonicOne Clinic Powered by Misonix

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Table of Contents
1. 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
2. Indications And Contra Indications..............................................................................................................14
2.1. Indications................................................................................................................................................. 14
2.2. Contra Indications ..................................................................................................................................... 14
3. Adverse Effects ................................................................................................................................................... 14
4. Considerations During Clinical Use..............................................................................................................15
4.1. SonicOne CLINIC Use ................................................................................................................................. 15
5. System Overview ................................................................................................................................................ 17
5.1. Principle Of Operation .............................................................................................................................. 17
5.2. Reusable System Components...........................................................................................................18
5.3. Single Use, Sterile Components .........................................................................................................19
6. 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
7. 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
8. Handpiece Assembly And Disassembly .......................................................................................................32
8.1. Handpiece Assembly..........................................................................................................................32
8.2. Handpiece Disassembly .....................................................................................................................33
9. 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
10. Troubleshooting ..........................................................................................................................................39
11. Specifications ...................................................................................................................................................... 42
12. Service, Repair AndTechnical 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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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 equipmentprotocols.
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.
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
For additional information not contained in this manual, please visit www.misionix.com
or contact your local sales representative.

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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
Compliance
Electromagnetic environment –guidance
RF emissions
CISPR 11
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.
RF emissions
CISPR 11
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.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
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.
Immunity test
IEC 60601
test level
Compliance level
Electromagnetic environment –guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
o±8 kV contact
o±2kV, ±5kV, ±8kV,
±15 kV air
o±8 kV contact
o±2kV, ±5kV, ±8kV,
o±15 kV air
Floors should be wood, concrete or ceramic tile.
If floors are covered with synthetic material, the
relative humidity should be at least 30%.
Electrical fast transient/
burst
IEC 61000-4-4
o±0.5 kV, ±1 kV
line to line
o±0.5 kV, ±1 kV, ±2 kV
line to ground
o±0.5 kV, ±1 kV
line to line
o±0.5 kV, ±1 kV, ±2 kV
line to ground
Mains power quality should be that of a
typical commercial or hospital environment.
Surge
IEC 61000-4-5
o ±1 kV differential
mode
o ±2 kV common mode
o ±1 kV differential
mode
o ±2 kV common
mode
Mains power quality should be that of a
typical commercial or hospital environment.
Voltage dips, short in-
terruptions and voltage
variations on power
supply input lines
IEC 61000-4-11
<0 % U
T
(100 % dip in U
T
for
0,5 cycle
70 % UT
(30 % dip in U
T
) for 25
cycles
0 % UT
(100 % dip in U
T
) for 1
cycles
0 % U
T
(100 % dip in U
T
) for 5
sec
0 % U
T
(100 % dip in U
T
) for
0,5 cycle
70 % UT
(30 % dip in U
T
) for 25
cycles
0 % UT
(100 % dip in U
T
) for 1
cycles
0 % U
T
(100 % dip in U
T
) for 5
sec
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.
Power frequency
(50/60 Hz) magnetic
field IEC 61000-4-8
30 A/m
30 A/m
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
NOTE U
T
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
3 Vrms
150 kHz to 80 MHz
3 V
d = 1.2√P
d = 1.2√P 80 MHz to 800 MHz
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.7GHz
3 V/m
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 andpeople.
Table 1.4 Guidance & manufacturer’s declaration on electromagnetic immunity (EN table 204)
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.

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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
power
of transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
d = 1.2√P
80 MHz to 800 MHz
d = 1.2√P
800 MHz to 2,7 GHz
d = 2.4√P
0.01
0.12
0.12
0.24
0.1
0.38
0.38
0.76
1
1.2
1.2
2.4
10
3.8
3.8
7.6
100
12
12
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 andpeople.
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.
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 onthe supplier andyou, 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
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
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.

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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 equipmentprotocols.
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.
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. Wear hearing protection or protect patient hearing if not within the
exposure limits.
WARNING 3.4 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 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 patientdeath.
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 Ensureallconnections and mating surfaces ofhandpiece,extension and ultrasonic tip are clean anddry
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 over-
tighten 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 over-
tighten 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
Table 1.6 Explanation of symbols
Console Related Symbols
Symbol
Description
Enable / Standby
Ultrasound
Scroll through
menu pages
Amplitude setting
Pulse setting
Flow setting
Do not reuse
Do not use
if packaging
is damaged
Contents are
latex-free
Do not expose to
temperatures
greater than
indicated
Must use hospital
grade powercord
only
Misonix CE
number
Contains DEHP
and/or Phthalates
Symbol
Description
Caution:
Dangerous voltage
Caution: Consult
accompanying
documents
Caution:
Pinch hazard
Consult
Instructions for Use
Type B equipment
Sterilized using
Ethylene Oxide
Sterilized using
Gamma Irradiation
YYYY- MM-DD
Use by date
indicated
Lot or batch code
Fuse
Classified by UL
Vacuum source
Symbol
Description
Mains Power ON
Mains Power OFF
Protective
earth ground
Equipotentiality
connection
Disposal to be
compliant with
EN 50419 (WEEE
directive)
Restricted to sale
by or on the order
of a physician only
Authorized
representative
Catalog number
AC Voltage
Manufacturer
Footswitch
connector
Irrigation Source
Warning:
Hearing Protection

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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%
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 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.
º BoneScalpel shaving tips are used for sculpting bone. They have an abrasive surface for bone
removal through abrasion under ultrasonic oscillation.
º SonicOne CLINIC multi-function tips can have a combination of blunt and abrasive cutting surfaces.
º 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