Misonix SonicOne O.R. User manual

Instructions For Use
SonicOne O.R. Powered by Misonix

E-SOUM-OR Rev M
2
Table of Contents
1. General Safety Statements ................................................................................................................................. 3
1.1 Summary of Safety Notices: Warnings, Cautions and Notes..................................................................... 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 O.R 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

E-SOUM-OR Rev M
3
1. General Safety Statements
WARNING 1.1 The SonicOne O.R 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 whenneeded.
WARNING1.2 The SonicOneO.Rsystem is intended tobeusedin various types ofinvasive, 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 O.R. system is to be used by an appropriately trained and licensed healthcare practitioner.
1.1. EMC Statement
The SonicOne O.R 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.
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 putinto service
according to the EMC information provided in this operator’s manual.
CAUTION 1.3 Portable and mobie RF communication equipment (including peripherals such as atenna cables and
external antennas) should be no closer than 20cm (12 inches) to any part of the SonicOne, including the
cables supplied with the SonicOne. Portable and mobile RFcommunication equipment can affect medical
electrical equipment. If RF equpiment is in use monitor the SonicOne O.R. for proper function during
procedure.
CAUTION 1.4 The use of accessories, transducers and cables other than those specified or provided by Misonix may result in
increased electromagnetic emissions or decreased electromagnetic immunity of the device and result in
improper operation. Use only Misonix branded equpiment and accessories.
CAUTION 1.5 Whenused adjacent to the other electrical equipment, the console should beobservedto verify normal
operation in the configuration in which it will be used.
For additional information not contained in this manual, please visit www.misionix.com
or contact your local sales representative.

E-SOUM-OR Rev M
4
Electromagnetic Compatibility Guidance (in accordance with UL/EN/IEC 60601-1)
Guidance And Manufacturer’s Declaration – Electromagnetic Emissions (Table 201)
The SonicOne O.R SYSTEM is intended for use in the electromagnetic environment specified below. The customer or the
user of SonicOne O.R 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 O.R 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 O.R SYSTEM is suitable for use inall 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)

E-SOUM-OR Rev M
5
Guidance And Manufacturer’s Declaration – Electromagnetic Immunity (Table 202)
The SonicOne O.R SYSTEM is intended for use in the electromagnetic environment specified below. The customer or the
user of the SonicOne O.R 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 ±6 kV contact
o ±8 kV air
o ±6 kV contact
o ±8 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 ±2 kV for power
supply lines
o ±1 kV for
input/outputlines
o ±2 kV for power
supply lines
o ±1 kV for
input/outputlines
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 commonmode
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
<5 % U
T
(>95 % dip in U
T
for 0,5 cycle
40 % UT
(60 % dip in U
T
)
for 5 cycles
70 % UT
(30 % dip in U
T
)
for 25 cycles
<5 % U
T
(>95 % dip in U
T
)
for 5 sec
<5 % U
T
(>95 % dip in U
T
)
for 0,5 cycle
40 % UT
(60 % dip in U
T
)
for 5 cycles
70 % UT
(30 % dip in U
T
)
for 25 cycles
<5 % U
T
(>95 % 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 O.R 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
3 A/m
3 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

E-SOUM-OR Rev M
6
Guidance And Manufacturer’s Declaration – Electromagnetic Immunity (Table 204)
The SonicOne O.R SYSTEM is intended for use in the electromagnetic environment specified below. The customer or the
user of the SonicOne O.R 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 O.R SYSTEM, including cables, than
therecommendedseparation 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 800MHz
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m
d = 2.3√P 800 MHz to 2.5 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 byan electromagnetic site survey,
a
should be less than the compliance level in each
frequency range.
b
Interference may occur inthe vicinity of equipment
marked with the followingsymbol:
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)
a
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 O.R SYSTEM is used exceeds the
applicable RF compliance level above, the SonicOne O.R 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 O.R SYSTEM.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

E-SOUM-OR Rev M
7
RecommendedSeparationDistances Between PortableAndMobileRF
Communications Equipment AndThe SonicOne O.RSystem (Table 206)
The SonicOne O.R system is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer orthe user of the SonicOne O.R System can help prevent electromagnetic interference by main-
taining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SonicOne
O.R 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 2,5 GHz
d = 2.3√P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
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 O.R system is designed and tested to comply with UL 60601-1 and EN 60601-1.
WARNING 1.3 The SonicOne O.R 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
withprotective earth. Install plug andreceptacles 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 voltate or frequency may cause the unit to
malfunction or to createa shockor fire hazard. Confirm that the voltage selector switch onthe 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.

E-SOUM-OR Rev M
8
1.3. Environmental Statement
This equipment consists of materials that may berecycled if disassembled by aspecialized company.Pleaseobserve 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
electronicequipment.Theregulations,calledDirectives,placeresponsibilitiesonthesupplierandyou,thepurchaser/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 beobtained 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 ofthis device should only be performed by qualified technicians authorized by Misonix, Inc. There are no
service controls accessible to theuser.

E-SOUM-OR Rev M
9
List Of Warnings
WARNING 1.1 The SonicOne O.R 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 whenneeded.
WARNING1.2 The SonicOneO.Rsystem is intended tobeusedin various types ofinvasive, 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 O.R 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
withprotective earth. Install plug andreceptacles 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.
WARNING1.5 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 3.1 Tipand irrigant temperatures may exceed the tissue necrosis point ifinsufficient 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. byadministering 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 iftip 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 O.R system and it’s accessories may emit harmful acoustic pressure if exposure exceeds
recommended limits.
WARNING 3.4 For the Wide Hatch Probe: Less than 50” (127 cm) tall patieents 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 mainfragment remaining attached tothe handpiece. All fragments must beretrieved 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.

E-SOUM-OR Rev M
10
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 ofthe 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 tempatures may exceed the tissue necrosis point with SonicOne O.R. 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 comprable 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 biocontaminated 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 O.R
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 dispoable 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 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.