Misonix Sonicone o.r. User manual

Instructions For Use

SonicOne O.R. Powered by Misonix

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Table of Contents

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

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 O.R 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

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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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

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

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.

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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 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)

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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

±6 kV contact

±8 kV air

±6 kV contact

±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

±2 kV for power

supply lines

±1 kV for

input/outputlines

±2 kV for power

supply lines

±1 kV for

input/outputlines

Mains power quality should be that of a

typical commercial or hospital environment.

Surge

IEC 61000-4-5

±1 kV differential

mode

±2 kV commonmode

±1 kV differential

mode

±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

(>95 % dip in U

for 0,5 cycle

40 % UT

(60 % dip in U

)

for 5 cycles

70 % UT

(30 % dip in U

)

for 25 cycles

<5 % U

(>95 % dip in U

)

for 5 sec

<5 % U

(>95 % dip in U

)

for 0,5 cycle

40 % UT

(60 % dip in U

)

for 5 cycles

70 % UT

(30 % dip in U

)

for 25 cycles

<5 % U

(>95 % dip in U

)

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

Power frequency magnetic fields should be at

levels characteristic of a typical location in a

typical commercial or hospital environment.

NOTE U

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 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,

should be less than the compliance level in each

frequency range.

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)

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.

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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

Separation distance according to frequency of transmitter

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

0.23

0.1

0.38

0.73

1.2

2.3

3.8

7.3

100

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.

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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.

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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.

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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 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.

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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 O.R 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 putinto service

according to the EMC information provided in this operator’s manual.

CAUTION 1.3 Portable and mobileRFcommunication equipment can affect medical electrical equipment. IfRF

equipment 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 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 beobserved to verify normal operation in the configuration in

which it will beused.

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 O.R 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 protion,

maybe necessary for removal ofvery dense, hard osseous structures ofthe skull, when using the SonicOne

O.R. accessories.

CAUTION 7.1 All reusable system components like handpiece, probe covers, counter wrench, and T-wrench are supplied

industrially cleaned, but NON-STERILE. All items intended for use in the sterile field must be cleaned and

sterilized as per the indicated instructions before first clinical use and before every subsequent clinical use.

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 Ensureallconnectionsandmatingsurfacesofhandpiece,extensionandultrasonictiparecleananddry

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.

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 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.

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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 ofthe 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

andmay resultin compromised performance, including failure. Discard anyextensions ortips 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,

foamorother 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 theT-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 theextension.

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 orun-tighten the irrigation tubing by hand and without using any wrenches.Do not over-

tighten the tubingconnector.

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

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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

E-SOUM-OR Rev M

Indications And Contra Indications

2.1.

Indications

The SonicOne O.R® is indicated for use in debridement of wounds, such as, but not limited to burn wounds, diabetic ul-

cers, bedsores andvaginal ulcers, soft tissue debridement and cleansing of the surgical site in application, in which, in the

physician’s judgement would require the use of an ultrasonic aspirator with sharp debridement.

It is also indicated for use in the fragmentation and aspiration of both soft and hard (e.g.: bone) tissue as used in the following

surgical specialties. Wound Care, Orthopedic Surgery, Plastic and Reconstructive Surgery, Thoracic Surgery, NeuroSurgery and

General Surgery.

The SonicOne O.R. 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 O.R is to be used by an appropriately trained and licensed healthcare

practitioner.

2.2.

Contra Indications

The SonicOne O.R. 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 O.R. ultrasonic surgical aspirator device is not indicated for and should not be used for the fragmentation,

emulsification, and aspiration of uterine fibroids.

Adverse Effects

Limits For Airborn 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

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 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 O.R 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 exporsure 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

E-SOUM-OR Rev M

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 O.R 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

100%

Very High

100%

90%

High

100%

80%

Standard (Default)

100%

70%

Moderate

100%

60%

Low

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 ampli-

tude setting in combination with higher irrigation would minimize or eliminate tissue necrosis.

•

Bone shaving tips tend to require a lower amplitude than cutting blades.

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.

E-SOUM-OR Rev M

Tip Limitations During Bone Removal

Both the ultrasonic tip and the extension are vibrating athigh frequency and are thus exposed to extreme mechanical stresses,

especially when cutting bone.

WARNING 4.2 Ultrasonic tips can break under excessive use in extreme conditions, e.g. when cutting for extended