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Misonix SonicOne O.R., Instructions For Use Manual

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Misonix SonicOne O.R. Instructions For Use Manual Download Page 3

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 when needed.

 

 

WARNING 1.2 

The SonicOne O.R system is intended to be used in various types of invasive, surgical procedures. There may 
be indirect danger to the patient should the device fail during the procedure. It is recommended that the 
facility follows its back-up equipment protocols.

 

 

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 put into 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 RF communication 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 

When used adjacent to the other electrical equipment, the console should be observed to 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.

 

Summary of Contents for SonicOne O.R.

Page 1: ...Instructions For Use SonicOne O R Powered by Misonix ...

Page 2: ... 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 Steri...

Page 3: ...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 put into 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 ate...

Page 4: ...ssions 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 SonicOneO RSYSTEMis suitableforuseinall establishments other than domestic and those directly connected to the public low voltage power supply network that ...

Page 5: ...cal commercial or hospital environment Voltage dips short in terruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec Mains power...

Page 6: ...ectromagnetic sitesurvey a should be less than the compliance level in each frequency range b Interference may occurinthe vicinity ofequipment 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 Ta...

Page 7: ...d 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 ens...

Page 8: ...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 Youmust ensure that the device is disposed of at an authorized treatment facility details canbe obtained from your loc...

Page 9: ...ng is 7 a minimum flow setting of 70 should be used Additional external irrigation e g by administering sterile salinewithasyringe over the distaltipportion 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...

Page 10: ...arded 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...

Page 11: ...icOne 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 ste...

Page 12: ...oftsurfacesincethe material may block the airvents Blockingthesevents may causeunitto 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...

Page 13: ...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 ...

Page 14: ...ids 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 3 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...

Page 15: ...icOne O R Use Recommended Settings The following settings are general guidelines and should be adjusted based on indication anatomy pathology andsurgeon s preference Amplitude Pulse Flow Highest 10 100 100 Very High 9 100 90 High 8 100 80 Standard Default 7 100 70 Moderate 6 100 60 Low 5 100 50 Table 4 1 Recommended settings A high amplitude setting results in more aggressive tissue removal a low ...

Page 16: ... can result in tip breakage during use Dispose of deformed or broken tips immediately in a sharps container CAUTION 4 2 Insufficient irrigation and high tip pressure loading under extended exposure e g in tight cavities are to be avoided in SonicOne O R hard tissue removal It is recommended to withdraw and re insert the ultrasonic tip repeatedly to re establish adequate cooling and lubrication CAU...

Page 17: ...tissue effects Wound Debridement Applications º Debridement probes are typically used for contact wound debridement Tissue excision and fragmentation are achieved through cavitation and other mechanical and hydrodynamic effects Applications Specialized tips are utilized on hard tissue structures º SonicOne O R blades typically used for cutting bone are usually flat and have a blunt active edge A c...

Page 18: ...included with the system may change over time please check with your Misonix representative for the most currentconfiguration Required System Components BCM GN EBC06 SonicOne O R System includes BCM GN console and footswitch 1 ea BCM GN EBC06 Misonix console Includes console and footswitch 1 ea SOM HP SonicOne O R handpiece 1 ea BCM CW Counter wrench for SonicOne O R handpiece 1 ea BCM 2W T Wrench...

Page 19: ...c tips are supplied sterile and are for single use only 6 Console 6 1 Receptacles Controls And Indicators The rear of the console features receptacles for the power cord fuses footswitch cable equipotentiality connector and IV pole as well as a switch for mains power The equipotentiality connector makes the connected equipment potential equal ref IEC 60601 1 1 2 3 4 Figure 6 1 1 Console rear 5 6 7...

Page 20: ... standby and menu access are provided on the left of the display panel An ultrasound timer indicates the elapsed time in which the ultrasound was on 1 2 3 4 5 6 A B C D E F 7 8 9 Figure 6 1 2 Console front Buttons A F perform various functions depending on the information displayed on the screen The display screen shown is the Main Screen used for all major control functions 1 Amplitude setting 2 ...

Page 21: ...litude Control The amplitude can be set between 0 and 10 Press A to increase and B to decrease the amplitude in increments of 1 The default setting for amplitude is 7 Refer to section 1 1 for further details on the Amplitude feature Pulse Control The pulse can be set between 50 and 100 Press C to increase and D to decrease the pulse in increments of 10 The default setting for pulse is 100 Refer to...

Page 22: ...e user to do the following re set the elapsed ultrasound time save and choose presets and adjust the display contrast 1 A B C D E F Figure 6 2 2 Options screen Ultrasound timer The elapsed ultrasound time can be re set to 00 00 by pressing either A or B Presets Preferred settings for amplitude pulse and flow can be saved as two presets A third preset features the default settings which cannot be c...

Page 23: ...ion and elon gates back to its resting point The peak to peak amplitude or stroke distance can be adjusted by changing the Amplitude from setting 1 10 This is the main parameter to control the rate of tissue removal A high amplitude setting results in more aggressivetissueremoval alowsetting inless aggressivetissueremoval Amplitudeandthus removal ratemay alter withsize and geometry of the ultrason...

Page 24: ...eriod Figure 6 3 1 Illustration of pulse setting Irrigation Proper irrigation with sterile saline ensures 1 Cooling of handpiece and vibratingelements 2 Cooling and lavage of the surgicalsite 3 Lubrication of bone tip interface for SonicOne O R hard tissueremoval The active ultrasonic probe remains cold when not in contact with tissue However when a tip contacts tissue heat is gen erated The heat ...

Page 25: ...dicator as long as the footswitch is depressed Ultrasound and Irrigation are deactivated temporarily Mechanical Limit Alert Alert Type Alert Screen Alert Action Mechanical Limit Displays LIMIT alertlocatedaboveamplitudesetting display Triggers apulsed audibleindicatorupon footswitch activation Temporarilydeactivatesultrasoundandirrigation functions Possible Cause Corrective Action Tip overload Rel...

Page 26: ... is displayed together with a steady audible indicator Ultrasound and Irrigation are deactivated Requires recycling of mains power switch to re set 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 ul...

Page 27: ...e first clinical use and before every subsequent clinical use WARNING 12 1 Connecting the console to a power outlet with inadequate voltage or frequency may cause the unit to malfunction or tocreateashock orfirehazard Confirm thatthevoltageselectorswitch ontheconsolerear panel is set to the local voltage setting and ensure that the correct fuses are being used Refer to section 12 1 on instructions...

Page 28: ...ew of console with air vents 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 foamorothersoftsurfacesincethe material may block the airvents Blockingthesevents may causeunitto overheat and malfunction or create a shock hazard A clear d...

Page 29: ...ptacle on console rear Footswitch connector and receptacle are keyed to ensure proper connection Turn cable connector until keys match Insert connector fully into receptacle Turn outer connector ring clockwise to lock into position Footswitch may be covered with clear drape during clinical use Switch Mains Power ON Set Mains Power switch on console rear to ON Front panel will display Main Screen u...

Page 30: ...ece and in direction of arrow on pumphousing Place and hold the tubing s silicone section in the V notches on both pump sides Apply slight pressure to ensure that tubing rests within both V notches Close pump cover Close the latch of the irrigation pump until it locks Connect Tubing to Connect IV Spike to fluid container following standard operating room protocol Fluid Container Prime Tubing Adjus...

Page 31: ...ation tubingpriorto use Atall times ensure thattheirrigant flows towards thehandpiece when footswitch is depressed If no irrigant is flowing cease use until flow is restored WARNING 7 3 Tip and irrigation temperatures 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 ...

Page 32: ...d as expected Refer to troubleshooting section for next steps Table 7 5 System check 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 The SonicOne O R system is now ready for use Refer to section 1 0 for general safety statements indications and adverse affects and section 5 0 for use of main sy...

Page 33: ...wrenches Do not over tighten the tubing connector Once the handpiece inspection is complete please see the selected tip s i e MXB 20 Instructions For Use included in the sterile packaged product for attachment instructions and use The handpiece is now ready for use and can be connected to the SonicOne O R system Please refer to Section 7 0 for details 8 2 Handpiece Disassembly WARNING 8 1 Remove p...

Page 34: ... HOLLOW GREY Switch Console OFF Set Mains Power switch on console rear to OFF Remove Handpiece Cable Pull cable connector from receptacle on console front Remove Tubing Open pump cover Remove tubing from pump compartment Disconnect tubing from irrigant container Wipe Down Console Wipe down the console Table 9 1 Console tear down Handpiece Disassembly Disassemble all handpiece components in reverse...

Page 35: ... and or sterilization if they differ from the procedures as outlined in this manual 9 2 1 Manual Cleaning Procedure The following items are considered reusable items and should be cleaned as recommended Console Footswitch Handpiece Counter wrench T wrench Probe cover Probe Cover and Wrenches Wash Brush Wash items with hot water mixed with an enzymatic detergent such as ASP Enzol or Steris Pro lyst...

Page 36: ...1 Do not use ultrasonic cleaners to clean the handpiece as this method could damage the 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 an...

Page 37: ... side a minimum of four times rotating the brush as it is inserted Rinse all residual soap from the handpiece under warm running water for a minimum of one minute Visually inspect internal and external surfaces of the handpiece including the pin cavity and repeat the above steps as required until all visible debris and staining are removed Automated Wash and Disinfection Whenplacingthehandpieceint...

Page 38: ...es NOTE 9 1 Allow reusable autoclavable items to gradually return to room temperature after steam sterilization and prior to usage 1 Tray wrapped in Kimberly Clark KC300 KIMGUARD sterilization wrap 2 Tray wrapped in Kimberly Clark KC300 or KC600 KIMGUARD sterilization wrap 3 Items wrapped in Kimberly Clark KC300 or KC600 KIMGUARD sterilization wrap Exposure time can be increased up to a maximum of...

Page 39: ...s Misonix Inc has validated all cleaning disinfection 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 t...

Page 40: ...ated Release the footswitch briefly and reduce the tip pressure e g by retrieving the ultrasonic tip Depress the footswitch again and continue with reduced tip pressure Consider using higher amplitude setting or reduced loading if stalling persists Electrical Fault Alert Alert Type Alert Screen Alert Action Electrical Fault Displays Electrical Fault Screen Triggerssteadyaudibleindicator Permanentl...

Page 41: ...ound to STANDBY Check tubing for kinking restrictions or leaks Replace tubing if necessary Check mounting in pump head Close pump cover until locked 4 Tubing installed in reverse Set ultrasound to STANDBY Open pump cover Reposition the tubing in direction of flow Close pump cover untillocked 5 Tubing slides through pump Set ultrasound to STANDBY Open pump cover Adjust the grip of the tubing by tur...

Page 42: ...mer with reset Menu button Six screen specific buttons Irrigation pump Peristaltic pump Pump flow rate Max flow 67 ml min Irrigation tubing Dedicated tubeset sterile single use Vented IV spike compatible with fluid bags and bottles Dedicated handpiece connection Handpiece cable 15 ft 4 6m Footswitch cable 14 ft 4 3m Footswitch IP 68 Generator IPX 0 Power cord 10 ft 3 0m Operating conditions Temper...

Page 43: ...o a supply withprotectiveearth Installplugandreceptacles as perlocalregulations beforeoperating theunit 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 12 1 Connecting the console to a power outlet with inadequate voltage or frequency may cause the...

Page 44: ...on the console rear Disable Ultrasound Switch toStandby Modeusing enable standby button Confirm that Amplitude setting is HOLLOW GREY Switch Console OFF Switch console OFF and disconnect power cord Remove Fuse Holder Pinch tab on fuse holder Pull fuse holder out Replace Fuses Replace both fuses as specified above Mount Fuse Holder Push fuse holder back into receptacle Switch Console ON Connect pow...

Page 45: ...head in place Turn pump head clockwise until it locks in place Arrow should be in the vertical position pointing down Table 12 2 1 Assembly of pump head Remove Pump Head Disable Ultrasound Switch toStandby Modeusing enable standby button Confirm that Amplitude setting is HOLLOW GREY Switch Console OFF Switch console OFF and disconnect power cord Remove Tubing Open pump cover Remove tubing Close pu...

Page 46: ...thod of shipment 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 ...

Page 47: ...certify that any and all materials so returned are or have been rendered free of any hazardous or noxious matter or radioactive contamination and are safe for handling under normal repair shop conditions Do not return any material for which such certification cannot be made without prior approval from Misonix Inc The correct return address should read as follows MISONIX Misonix Inc Medical Service...

Page 48: ...M OR Rev M 1 631 694 9555 phone 1 631 694 3285 FAX 1938 NEW HIGHWAY FARMINGDALE N Y 11735 U S A MISONIX INC NASDAQ SYMBOL MSON MISONIX COM 2017 Misonix Inc All rights reserved Printed in the USA E SOUM OR Rev M ...

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