Misonix sonicone Clinic, Instructions For Use Manual

Page 1: ...Instructions For Use SonicOne Clinic Powered by Misonix ...

Page 2: ...9 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 Disassembl...

Page 3: ...ter J and to comply with IEC EN60601 1 2 guidelines for EMC CAUTION 1 2 This device is considered medical electrical equipment Medical electrical equipment needs special precautions regarding electromagnetic compatibility EMC andneeds to be installed and put into service according to the EMC information provided in this operator s manual WARNING 10 2 Portable and mobile RF communication equipment ...

Page 4: ...SYSTEM issuitable 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 NOTE The EMISSI...

Page 5: ... 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 0 UT 100 dip in UT for 0 5 cycle 70 UT 30 dip in UT for 25 cycles 0 UT 100 dip in UT for 1 cycles 0 UT 100 dip in UT for 5 sec 0 UT 100 dip in UT for 0 5 cycle 70 UT 30 dip in UT for 25 cycles 0 UT 100 dip in UT for 1 cycles 0 UT 100 dip in UT fo...

Page 6: ...anelectromagnetic sitesurvey a should be less than the compliance level in each frequency range b Interference mayoccurinthe vicinityofequipment 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 ...

Page 7: ...nd reflection from structures objects andpeople Table 1 5 Recommended separation distances EN table 206 1 2 Electrical Safety Statement The SonicOne CLINIC system is designed and tested to comply with UL 60601 1 and EN 60601 1 WARNING 1 3 The SonicOne CLINIC system generates high voltages within the console itself and the connected handpiece To avoid injury the console should never be operated bef...

Page 8: ...u 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 l...

Page 9: ...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 by administering sterile saline with asyringe over the distaltip 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 sweepin...

Page 10: ...o 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 CLINIC system and related accessories be followed It is the responsibility of the user of this device or any accessories used with it to valid...

Page 11: ...on 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 CLINIC 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 asyrin...

Page 12: ...ngle use items CAUTION 9 6 The probes need to be examined after use for nicks gouges or wear that could have a negative impact upon ultrasonic performance or could lead to destruction of the instrument CAUTION 9 7 Do not use ultrasonic cleaners to clean the handpiece as both methods could damage handpiece CAUTION 12 1 Use only genuine replacement parts from Misonix Use of parts furnished by other ...

Page 13: ...y blockthe air vents Blockingthese ventsmaycause unit to overheat and malfunction or create ashock 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 the...

Page 14: ... 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 15: ... licensed healthcare practitioner The SonicOne CLINIC is to be used by an appropriately trained and licensed healthcare practitioner 2 2 Contra Indications The SonicOne CLINIC 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 adm...

Page 16: ...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 CLINIC Use Recommended Settings The following settings are general guidelines and should be adjusted based on ind...

Page 17: ...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...

Page 18: ...fects Applications Specialized tips are utilized on hard tissue structures º BoneScalpel blades typically used for cutting bone are usually flat and have a blunt active edge A compression cut is achieved through repetitive impacts on the bone at an ultrasonic frequency º BoneScalpel shaving tips are used for sculpting bone They have an abrasive surface for bone removal through abrasion under ultra...

Page 19: ...ed as a system or individually Required System Components E SOP GEN Misonix console Includes IV pole power cord footswitch peristaltic pump and instructions for use E SOP HP SonicOne CLINIC handpiece BCM CW Counter wrench for SonicOne CLINIC handpiece E PWRCH 7 16th Probe Wrench BCM SS Probe Cover BCM H2 Soft Tissue Probe Cover Table 5 2 Required system components Components and quantities include...

Page 20: ...the system may change over time please check with your Misonix representative for the most current configuration Ultrasonic probes are supplied NON Sterile and can be reused At least one of the following probes must be available for each surgical procedure Table 5 3 Autoclavable Debridement Probes ...

Page 21: ...sentative for assistance with ordering SonicOne OR or BoneScalpel tips for use with the SonicOne Clinic console and handpiece Warning SonicOne OR and BoneScalpel probe tips are sterile single use disposable items Do not attempt to clean re sterilize or reuse SonicOne OR and BoneScalpel probe tips Warning Single use items should be discarded following each surgical procedure according to hospital p...

Page 22: ...nformation displayed on the screen The display screen shown is the Main Screen used for all major control functions The handpiece receptacle is keyed in order to facilitate connection The red dot on top of the receptacle must be in line with the corresponding red dot on the handpiece cable 6 2 Menu Functions The standard screen is the Main Screen Additional screens are the Options and the Help Scr...

Page 23: ...ed time in which the ultrasound was activated with the footswitch The timer can be re set to zero via the secondary screen In the event of error such as a Mechanical Limit or an Electrical Fault the main screen is replaced by alert screens Refer to section 6 4 for a description of these warnings Options Screen The Options Screen allows the user to do the following re set the elapsed ultrasound tim...

Page 24: ...tion 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 alowsettinginless aggressivetissueremoval Amplitudeandthus removalratemay alter withsize and geometry of the ultrasoni...

Page 25: ...sting period 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 hard tissue removal The active ultrasonic probe remains cold when not in contact with tissue However when a tip contacts tissue heat is gen erated The heat incre...

Page 26: ...icator 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 audible indicator upon footswitch activation Temporarilydeactivatesultrasoundandirrigation functions Possible Cause Corrective Action Tip overload Re...

Page 27: ...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 Electrical Fault Alert Alert Type Alert Screen Alert Action Electrical Fault Displays Electrical Fault Screen Triggersste...

Page 28: ...may cause the unit to malfunctionor tocreate ashockor fire hazard 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 for fuse replacement See section 12 1 for instructions on adjusting to local electrical requirements Care should be taken to stay within the general op...

Page 29: ... receptacle in console rear Hang container with sterile physiological saline irrigant into IV pole hook Irrigation tubing features IV spike and is compatible with rigid bottles or flexible bags Check Mains Fuses See section 12 1 Check Voltage Selector Voltageselector switch seesection 6 1 forlocation shall be placed in apositionthatis dependent on the model and hospital voltage Model Line Voltage ...

Page 30: ...e assembly and disassembly Once the handpiece has been assembled continue with part II of the Console Set Up 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 Proceed to next page ...

Page 31: ...iece andin 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 32: ...on tubing priorto use At all times ensure that theirrigant flows towardsthe handpiece 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 CLINIC accessories for hard tissue removal if insufficient irrigation flow rates are used Always set the irrigation flowrate for ha...

Page 33: ...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 CLINIC system is now ready for use Refer to section 1 0 for general safety statements indications and adverse effects and section 5 0 for use of main s...

Page 34: ...E SOUM PLUS Rev E 34 Table 8 2 Handpiece Assembly for debridement ...

Page 35: ...ece inspection is complete please see the selected tip s i e E SOP C1 Instructions For Use included in the packaged product for attachment instructions and use The handpiece is now ready for use and can be connected to the SonicOne CLINIC system Please refer to Section 7 0 for details If desired mount suitable sterile cable clips or sterile adhesive tape strips to attach irrigation tubing to handp...

Page 36: ... Table 8 2 Irrigation tube and handpiece disassembly Once irrigation tube is disconnected please see the selected tip s i e MXB 20 Instructions For Use included in the sterile packaged product for disassembly instructions ...

Page 37: ...ose according to facility s procedures for disposal of single use items 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 order of assembly Please refer to Section 8 2 for disassembly after surgical proce...

Page 38: ... 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 Probe Cover and Wrenches Wash Brush Wash items with hot water mixed with an enzymatic detergent such as ASP Enzol or Steris Pr...

Page 39: ... 9 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...

Page 40: ...r 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 andrepeat the above steps as required until all visible debris and staining are removed Automated Wash and Disinfection When placing the handpiece...

Page 41: ...4 279 F 134 C 273 F Configuration Items wrapped NO TRAY3 Items wrapped NO TRAY3 Items wrapped NO TRAY3 Cycle Prevacuum Prevacuum Gravity Preconditioning Pulses 4 4 None Minimum Exposure 4 minutes 3 minutes 20 minutes Minimum Dry Time 45 minutes 30 minutes 5 minutes SonicOne Clinic Probes Wrapped No Tray Table 9 3 2 Steam sterilization cycles 132 C 270 F 134 137 C 274 279 F Configuration Itemsplace...

Page 42: ...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 18 minutes to comply with local requirements and or recommenda tions of the World Health Organization WHO Robert Koch Institute RKI etc Misonix Inc reusable medical devices are able to sustain such s...

Page 43: ...tructions 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 CLINIC 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 sterili...

Page 44: ...vated 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 Permanent...

Page 45: ...rasound 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 ...

Page 46: ...er 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 Tempera...

Page 47: ... be connected to a supply with protectiveearth Install plug andreceptacles as perlocalregulations beforeoperating 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 12 1 Connecting the console to a power outlet with inadequate voltage or freq...

Page 48: ...d on the console rear Disable Ultrasound Switch toStandby Mode usingenable 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 p...

Page 49: ...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 Mode usingenable 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 50: ...ethod 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 51: ...ertify 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 52: ... E SOUM 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 2018 Misonix Inc All rights reserved Printed in the USA E SOUM OR Rev P ...