Misonix sonastar SYSTEM-M200 User manual

FS-1000-RF

Instructions for Use SonaStar Ultrasonic Surgical Aspiration System
IFU-601 Rev T March 2023 Page 1 of 71
TABLE OF CONTENTS
1. Operating Safety Precautions ................................................................................................... 4
1.1 General ................................................................................................................................ 4
1.2 Conventions: Warnings, Cautions, and Notes ....................................................................... 4
1.3 Safety: Recommendations for the Use of this Device ...................................................... 4-12
1.4 Handling of Handpieces ..................................................................................................... 13
1.5 Explosion and Fire Hazard .................................................................................................. 13
1.6 High Voltage Hazard .......................................................................................................... 13
1.7 Power Receptacle and Plug ................................................................................................ 13
1.8 Grounding the Unit ............................................................................................................ 13
1.9 Using the Proper Fuse ........................................................................................................ 14
1.10 Standards, Classifications and Symbols Used ................................................................. 14-17
2. Installation ............................................................................................................................. 18
2.1 Space Requirements .......................................................................................................... 18
2.2 Environmental Limitations ................................................................................................. 18
2.3 Electrical Requirements .................................................................................................... 19
2.4 Unpacking and Inspection .................................................................................................. 19
2.5 Equipment List ................................................................................................................... 19
3. System Description ................................................................................................................. 20
3.1 Surgical Indications ............................................................................................................ 20
3.2 Contradictions .................................................................................................................... 20
3.3 Ultrasonic Theory ............................................................................................................... 20
3.4 System Overview .......................................................................................................... 21-22
3.5 Vibration System ................................................................................................................ 23
3.6 Irrigation System ................................................................................................................ 23
3.7 Aspiration System .............................................................................................................. 24
3.8 Wireless Footswitch ...................................................................................................... 24-25
4. Controls, Indicators and Connections ........................................................................................ 26
4.1 Overall System .............................................................................................................. 26-27
4.2 Front Panel .................................................................................................................... 28-30
4.3 Components Rear View: Controls & Indicators ...............................................................31-32
4.4 Wireless Indicators ........................................................................................................ 33-34
5. Handpieces ............................................................................................................................. 35
5.1 General .............................................................................................................................. 35
5.2 Handpiece Types ................................................................................................................ 35
5.3 Handpiece Assembly ..................................................................................................... 36-40
5.4 Electrosurgery Connector Assembly .................................................................................. 40
6. System Operating instructions ................................................................................................. 41
6.1 Pre-Operative Preparation ................................................................................................. 41
6.2 Handpiece Preparation .................................................................................................. 42-43
6.3 Preparing the SonaStar for Use: .................................................................................... 44-46
6.4 System Setup ................................................................................................................ 46-47
6.5 Operative Use .................................................................................................................... 48
6.6 Post-Operative Procedure .................................................................................................. 49
7. Monopolar Coag Guidelines...................................................................................................... 50
7.1 Background ................................................................................................................... 50-51
7.2 Preparing the System for Monopolar COAG Use ........................................................... 52-53
7.3 Using Monopolar COAG with the System ...................................................................... 54-55

Instructions for Use SonaStar Ultrasonic Surgical Aspiration System
IFU-601 Rev T March 2023 Page 2 of 73
8. Cleaning, Sterilization and Maintenance .................................................................................. 56
8.1 General Information ........................................................................................................... 56
8.2 Cleaning Procedures ..................................................................................................... 56-58
8.3 Sterilization .................................................................................................................. 59-60
8.4 Service & Repair Information ............................................................................................. 60
8.5 Routine Maintenance ......................................................................................................... 60
8.6 Periodic Maintenance ................................................................................................... 60-61
8.7 Fuse Replacement………………………………………………….……………………….. 61
8.8 Moving the Unit .................................................................................................................. 61
8.9 Warranty Information……………………………………………………………………………...........61
9. Troubleshooting .....................................................................................................................62
9.1 Clearing Faults ................................................................................................................... 62
9.2 Overriding Faults ............................................................................................................... 62
10. Specifications ......................................................................................................................... 65
10.1 Ultrasonic Surgical Aspirator Generator ............................................................................. 65
10.2 Footswitch/Remote IR Receiver .......................................................................................... 67
10.3 Fuse Requirements ............................................................................................................ 69
10.4 UL Classification ................................................................................................................ 69
10.5 Accessories.. ....................................................................................................................... 70
10.6 Important Notice………………………………………………..………………………………………71

Instructions for Use SonaStar Ultrasonic Surgical Aspiration System
IFU-601 Rev T March 2023 Page 3 of 73
Table of Figures
Figure 1
-
1
SonaS
tar Ultrasoni
c
Surgi
cal Aspiration
System
1
2
Figure 2
-
1
Top View
Dim
ensions
1
8
Figure 3
-
1
SonaStar Ultrasonic Surgical Aspiration System
2
2
Figure 3
-
2
Wireless Footswitch
2
4
Figure 3
-
3
Wireless Footswitch with
I
ntegrated IR Receivers on
C
onsole
T
op and
L
eft
2
5
Figure
4
-
1
Top / Side
View Features
2
6
Figure 4
-
2
Lower Rear View
2
7
Figure 4
-
3
Control Panel
Features
28
Figure 4
-
4
Remote IR Receiver
3
0
Figure 4
-
5
Rear View Details
3
1
Figure 4
-
6
Lower Rear View Details
3
1
Figure 4
-
7
Low Battery and Footswit
ch Acti
vation LED(s)
3
3
Figure 4
-
8
Integrated IR Receiver and Remote IR Receiver
3
3
Figure 4
-
9
Wireless Footswitch
3
4
Figure 4
-
10
Matching Wireless Footswitch and Receiver Frequency Codes
3
4
Figure 5
-
1
(A) Curved Extended (CE) and (B) Short Straigh
t (SS)
Handpieces
3
5
Figure 5
-
2
Placing SS & CE Handpieces in the Counter Wrench
3
7
Figure 5
-
3
Exploded View of CE Handpiece Parts
38
Figure 5
-
4
CE Housing Tip Assembly
38
Figure 5
-
5a
Exploded View of SS Handpiece Parts
39
Figure 5
-
5b
Exploded Vie
w of SS
Handpiece Parts with Long Curved Probe
39
Figure 5
-
5c
Exploded View of
SS Handpiece Parts with Pricision, Micro and Standard Long Curved
Probe
39
Figure 5
-
5d
Exploded View of SS Handpiece Parts with Deep Access Probe
39
Figure 5
-
6
Handpiece wit
h Monop
ola
r Cable Connections
4
0
Figure 6
-
1
Open Irrigation Pump Gate
4
5
Figure 6
-
2
Routing of Irrigation Tubing
4
5
Figure 7
-
1
Console with Force 2 Electrosurgical Generator
5
0
Figure 7
-
2
Monopolar COAG Interface Schematic
5
1
Figure 7
-
3
Force2 Re
ar Conn
ections
5
2
Figure 7
-
4
Monopolar Handpiece Cable Attached to Endcap Receptacle
5
3
Figure 7
-
5
Force2 Front Connections
5
4
Figure 8
-
1
External Filter Installed
61
Figure 8
-
2
Internal Filter Assembly
61

Instructions for Use SonaStar Ultrasonic Surgical Aspiration System
IFU-601 Rev T March 2023 Page 4 of 73
CHAPTER 1
OPERATING SAFETY PRECAUTIONS
1.1 General
Please read this section of the manual carefully. It contains a summary of all warnings, cautions, and
notes contained in the manual. However, the user is strongly advised to read the entire manual and
operate the SonaStar system in accordance with all the instructions contained herein in addition to
instructions that may be supplied with accessories.
1.2 Conventions: Warnings, Cautions, and Notes
Warning Denotes potentially dangerous situation that could result in death or serious injury to
patient, operator, or staff.
Caution Denotes potentially dangerous situation that could result in moderate injury to patient,
operator, or staff.
Note
Indicates potential hazard that may result in product damage
1.3 Safety: Recommendations for the Use of this Device
Warning
Use of controls or adjustments, or performance of procedures other than as specified
herein may result in personal injury. Therefore, personnel operating or maintaining the
SonaStar system must be thoroughly familiar with its safety requirements and
operating procedures.
Any improper use or adjustment of this device may invalidate the Misonix Service
Warranty agreement. Please contact your authorized Misonix representative before
attempting to use this device in any manner other than those specified in this manual.
There are no user serviceable parts.
Misonix expressly disclaims all liability for any incidental or consequential damages to
the equipment or any personal injuries to the operator or patient arising from any
una
uthorized use, misuse or abuse of this equipment.
Warning
Proper system grounding cannot be ensured unless unit is connected to a properly
wired hospital grade outlet. Therefore, to avoid the risk of electric shock, this
equipment must only be conn
ected t
o supply mains with protective earth.
Warning During vibration testing, make sure the tip of the handpiece is free from contact with
any object. Allowing contact with the tip may result in damage and/or personal injury.
Warning Once vibration is enabled by pressing either the Preset or Linear key, depressing the
footswitch will initiate vibration. Make sure that the handpiece is properly positioned
at the tissue site before the footswitch is depressed. Any inadvertent activation of the
footswitch
will in
itiate v
ibration. DO NOT TOUCH
tip while activated.
Warning During system setup, a handpiece ultrasonic vibration test is required. Do not touch the
tip while testing the handpiece or at any time during operation as equipment damage
and/or personal injury may result. Do not allow the distal end of the tip to come in
contact with any object.
Warning Do not lay the handpiece on the patient when not in use. When not in use, keep the
handpiece on a dry, non-conductive surface with the tip free from contact with any
objects.
Warning Inadvertent or improper foot pedal depression can cause possible injury to the patient,
surgeon, or operating room staff, and can cause product damage. Place foot pedal
where it is highly visible, and labels can be clearl
y seen.

Instructions for Use SonaStar Ultrasonic Surgical Aspiration System
IFU-601 Rev T March 2023 Page 5 of 73
Warning
Saline leakage through handpiece housing can cause a hazard when electrosurgery is
energized. Always make sure the handpiece housing parts are properly assembled,
with mating parts firmly in contact.
Warning Never activate Vibration or electrosurgery while using the cleaning stylet. Tip damage
and operator, patient, or staff injury may result.
Warning Improper assembly of Single-Use Monopolar Handpiece Cable to endcap can expose
potentially dangerous electrosurgery voltage. Always make sure the Single-Use
Monopolar Handpiece Cable socket is firmly and fully engaged onto the pin in the
endcap.
Warning The handpiece and cable should be carefully inspected for cuts, cracks, or other signs of
damage before each use. Any damaged equipment should be returned to your sales
representative or dealer for repair or replacement.
Warning Use only sterilization cycles specified in this user manual. Do not use any other
sterilization cycles. Improper sterilization can lead to handpiece or accessory damage,
patient injury, or death.
Warning Explosion hazard. Never use the SonaStar system in the presence of a flammable or
explosive atmosphere, such as flammable anesthetics.
Warning The Sonastar system, including all accessories and components, is MR unsafe.
It must not brought into the MR environment.
Warning The use of accessories, transducers and cables other than those specified, with the
exception of transducers and cables sold by the manufacturer of the SonaStar
Ultrasonic Surgical Aspirator as replacement parts for internal components, may result
in increased emissions or decreased immunity of the SonaStar Ultrasonic Surgical
Aspirator.
Warning The SonaStar Ultrasonic Surgical Aspirator should not be used adjacent to or stacked
with other equipment. If adjacent or stacked use is necessary, the SonaStar Ultrasonic
Surgical Aspirator should be observed to verify normal operation in the configuration in
which it will be used.
Caution
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 SonaStar Ultrasonic Surgical Aspirator is to be used by an appropriately
trained and licensed healthcare practitioner.
Caution
The handpiece, accessories,
cables,
footswitch, remote IR receiver and generator
should never be immersed in liquids, since irreparable damage may result.
Caution The "Vacuum" port of the suction canister should contain a positive shut-off float. The
aspiration pump connection should be made only to the vacuum port to prevent
overflow contamination.
Caution Incorrect routing of irrigation tubing will result in no flow of irrigating solution to the
tip. This may cause damage to handpiece and probe.
Caution Be careful not to scratch or damage the tip when sliding the torque wrench over the
tip. Failure may result from scratches or damage to the probe when enabl
ing vibration.
Caution Do not use ultrasonic cleaners to clean the Handpiece. Use manual cleaning
techniques only.
Caution Be certain to clear all particles and any debris from the Handpiece internal passage and
all cavities by brushing thoroughly. Failure to do so may hinder sterilization of units
during autoclaving.
Caution
Use only a
SonaStar
CFSM2
-
T018
torque wrench
and
a C
FSM6
-
T222
fixture
.

Instructions for Use SonaStar Ultrasonic Surgical Aspiration System
IFU-601 Rev T March 2023 Page 6 of 73
Caution OsteoSculpt™ bone shaver probes are only to be installed on and used in conjunction
with Short
Straight (SS) handpiece.
Caution Never operate the handpiece without proper irrigation. Irreparable damage to the
handpiece
and pr
obe may result if adequate irrigation is not provided to the probe tip.
Caution The console and wireless footswitch must have the same frequency code number for
proper operation.
Caution Only the external surfaces of the console should be cleaned. Do not attempt to remove
any panels in order to clean or disinfect internal surfaces.
Caution It is strongly advised that a sterile backup handpiece be readily available in the
operating room as insurance against any contamination or malfunction of the
handp
iece during surgery.
Caution Improper use or adjustment of this device may invalidate the Misonix, LLC warranty
agreement. Contact your authorized Misonix, LLC representative before attempting to
troubleshoot this device in any manner other than
those s
pecified in this manual.
Caution
Do not immerse the Handpiece, Cable, Footswitch, Remote IR Receiver or Generator.
Caut
ion
The console is not sealed against liquids, and damage to equipment may result.
Caution If fault occurs suspend operation of handpiece and unit. Determine the cause of the
problem and its solution by consulting the troubleshooting section of this manua
l.
Caution Simultaneous use of a separate monopolar instrument with ultrasound can create
sparking and possible tip damage.
Caution Electrosurgery units approved for use with this unit are listed in Section 7.1. Any
electrosurgery units used with this system should be operated at settings lower than
70. Failure to maintain the electrosurgery signal at settings below 70 can induce
per
manent system damage.
Caution Use of a separate monopolar instrument at electrosurgery settings greater than 70
while simultaneously touching the handpiece probe to tissue can induce faults and
possible system damage.
Caution
COAG should not be us
ed in c
onjunction with bone shaving.
Caution
Vibrating tip cont
act with hard objects can cause
tip damage.
Caution
Sale of this d
evice is limited to or on the order of a physician only.
Caution Aspiration pinch valve and irrigation pump can create pinch points. Keep fingers away
from these parts while operating unit. Use caution when assembling components.
Caution
The only fuses
that may be replaced by hospital technical staff are the three fuses on
the rear of the unit. Replacement fuses must be identical in type, voltage rating and
current rating to the original fuse.
Caution
The
SonaStar
Ultrasonic
Surgical Aspirator is consi
dered 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.
Ca
ution
Portable and mobile RF communication equipment can affect Medical Electrical
Equipment.
Note The Low Battery LED indicator should be checked when system is powered “ON”.
Note The IV pole should be positioned to yield continuous flow and visibility, but elevated IV
bag position is not necessary to achieve flow.

Instructions for Use SonaStar Ultrasonic Surgical Aspiration System
IFU-601 Rev T March 2023 Page 7 of 73
Note Inspect the output end of the handpiece where the probe is attached. Make sure this
surface is clean and has no scratches or marks. Inspect the threads for signs of damage
or excessive wear. Do not use if it appears damaged.
Note The electrosurgery umbilical cable should be inspected for cuts, cracks, connector
damage, or any other signs of damage before use. Do not use the cable if it appears
damaged.
Note The SonaStar system should be fully tested and inspected prior to each procedure. The
console, footswitch, handpieces, all cables and accessories should be examined for
proper appearance and condition, and the initial system setup test should be
performed with each handpiece to ensure proper operation.
Note The pinch valve should be checked for proper operation during setup. Proper tubing
routing and pinch valve operation should be checked.
Note
The
SonaStar
is
configured for electrical input (line) at the factory before shi
pment,
and is not intended to be configured or changed in the field except by Misonix, LLC
authorized technical personnel. The unit may only be used with the electrical input
originally intended.
Note
A second torque wrench is highly recommended to al
low continued system usage
during wrench recalibration. See Chapter 8 for more information on torque wrench
recalibration.
Note If the footswitch’s activation LED does not illuminate, plug the Remote IR receiver into
its receptacle at the console rear and place it within direct line of sight with the
footswitch. The Remote IR receiver can be moved closer to the wireless footswitch or
linked directly to it to improve signal reception as needed.
Note
If COAG is to be performed, the Single
-
Use Monopolar H
andpiece Cable must be
introduced into the sterile field, because the cable is supplied sterile, and is NOT
AUTOCLAVABLE. DO NOT RE-STERILIZE THE SINGLE-USE MONOPOLAR
HANDPIECE CABLE.
Note The SonaStar system has been designed for use with monopolar COAG using a
Misonix-approved electrosurgical generator. CUT MODE HAS NOT BEEN APPROVED
FOR USE WITH THE SonaStar. DO NOT USE CUT MODE WITH THIS DEVICE.
Note Do not clean the tip with abrasive or metallic materials, as damage to the tip may result
in device failure.

Instructions for Use SonaStar Ultrasonic Surgical Aspiration System
IFU-601 Rev T March 2023 Page 8 of 73
FCC Statement: This complies with FCC regulations for conducted and radiated emissions under
FCC Part 18.
UL Statement: This complies with UL Standard 2601-1 as well as IEC 60601-1.
EMC Statement: The SonaStar 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:
2007 guidelines for EMC.
List of cables, transducers and accessories:
Item Cable Length Type
Ultrasonic Transducer NA NA
Transducer Cable 5.2m shielded multi-conductor
Remote IR Receiver Cable 5.5m shielded multi-conductor
AC Main Power Cord 3.0m unshielded 3-conductor
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
(Table 201)
The SonaStar Ultrasonic Surgical Aspirator is intended for use in the electromagnetic environment specified below. The customer or the user of
the Ultrasonic Surgical Aspirator should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment – Guidance
RF emissions
GB 4824
Group 1
The SonaStar Ultrasonic Surgical Aspirator 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
GB 4824
Class A
The SonaStar Ultrasonic Surgical Aspirator 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
GB 17625.1
Class A
Voltage fluctuations/
flicker emissions
GB 17625.2
Complies

Instructions for Use SonaStar Ultrasonic Surgical Aspiration System
IFU-601 Rev T March 2023 Page 9 of 73
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
(Table 204)
Ultrasonic surgical suction system Expected to use in the following electromagnetic environment, buyers or users should ensure
that it uses in the electromagnetic environment:
Immunity test IEC 60601 Test level In line with levels Electromagnetic environment —
Guide
Electrostatic discharge
GB/T 17626.2
±6 kV Contact discharge
±8 kV Air discharge
±6 kV Contact discharge
±8 kV Air discharge
Floors should be wood,
concrete or ceramic tiles, if the
ground covered with synthetic
material, the relative humidity
should be at least 30%
Electrical fast
transient/burst
GB/T 17626.4
±2 kV On the power supply
line
±1 kV On the input / Output
lines
±2 kV On the power supply
line
±1 kV On the input / Output
lines
Net power supply should be
used in a typical commercial or
hospital environment quality
Surge
GB/T 17626.5
±1 kV Wire to wire
±2 kV Line to ground
±1 kV Wire to wire
±2 kV Line to ground
Net power supply should be
used in a typical commercial or
hospital environment quality
Power supply input voltage
dips, short interruptions
and voltage variations
GB/T 17626.11
< 5% U
T
, Continued 0.5 Cycle
(In the U
T
Shang, > 95% SAG)
40% U
T
, Continued 5 Cycle
(In the U
T
Shang, 60% SAG)
70% U
T
, Continued 25 Cycle
(In the U
T
Shang, 30% SAG)
< 5% U
T
, Continued 5s
(In the U
T
Shang, > 95% SAG)
< 5% U
T
, Continued 0.5 Cycle
(In the U
T
Shang, > 95% SAG)
40% U
T
, Continued 5 Cycle
(In the U
T
Shang, 60% SAG)
70% U
T
, Continued 25 Cycle
(In the U
T
Shang, 30% SAG)
< 5% U
T
, Continued 5s
(In the U
T
Shang, > 95% SAG)
Mains should have a typical
commercial or hospital
environment with quality.
Ultrasonic surgical suction system
user requires continuous
operation during power
interruption, it is recommended
to Ultrasonic surgical suction
system using an uninterruptible
power supply or battery powered
Power frequency magnetic
field ( 50 Hz/60 Hz )
GB/T 17626.8
3 A/m 3 A/m
Power frequency magnetic
fields should have in a typical
commercial or hospital
environment, level of power
frequency magnetic field
characteristics of typical sites
Note: U
T
Before the test voltage applied AC voltage.