Misonix SonicOne O.R. User manual

Instructions For Use
SonicOne O.R. Powered by Misonix

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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

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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.

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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
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