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BoneScalpel User Manual

1. Do not pinch the soft silicone tube when the latch is locked ToS Eer 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 Tip and irrigation temperatures may exceed the tissue necrosis point with BoneScalpel 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 comparable vibration setting For example if the vibration setting is 7 a minimum flow setting of 70 should be used 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 Page 32 Instructions For Use BoneScalpel with SonicOne Technology increase The BoneScalpel System is now ready for the system check 7 5 Perform System Check System Check Enable Ultrasound Switch to Enable Mode using enable standby button Confirm that Amplitude setting is FILLED GREEN Dep
2. System Contents Ka BCM GN BoneScalpel console 1 ea Includes IV pole power cord footswitch peristaltic pump and instructions for use BCM HP BoneScalpel handpiece universal for hard and soft tissue applications Table 11 2 System contents Components and quantities included with the system may change over time please check with your Misonix representative for the most current configuration BCM UM Rev H Page 50 Instructions For Use BoneScalpel with SonicOne Technology 12 Service Repair And Technical Correspondence 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 with protective earth Install plug and receptacles 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 12 1 Fuse Replacement 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 Fuse Specifications P N
3. BCM UM Rev H MXB 20LC CH pes e Includes blade long curved extension and silicone sleeve BoneScalpel with SonicOne Technology Requires BCM SS probe cover Requires BCM SS probe cover Requires BCM SS probe cover Requires BCM SS probe cover Requires BCM H2 probe cover Requires BCM H2 probe cover Requires BCM H2 probe cover Page 20 Instructions For Use BoneScalpel with SonicOne Technology BCM UM Rev H Page 21 Instructions For Use BoneScalpel with SonicOne Technology 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 IV pole receptacle Mains power on off Power cord receptacle with fuse block Voltage selector switch Cooling fan Equipotentiality connection Footswitch receptacle LA N e N OUI P Figure 6 1 Console rear The front of the console features a receptacle for the handpiece cable and an irrigation pump head in which the irrigation tubing is inserted A large color LCD screen provides information on system status and set points for ultrasound amplitude pulse rate and irrigant flow rate with respective controls on the panel below Additional controls for ultrasound enable standby a
4. BO Un DU Hin 100 Duty Cycle 0 29 50 De 100 125 150 175 200 225 250 ms Figure 6 6 Illustration of pulse setting Irrigation Proper irrigation with sterile saline ensures 1 Cooling of handpiece and vibrating elements 2 Cooling and lavage of the surgical site 3 Continuous presence of cavitation medium for SonicOne soft tissue removal 4 Lubrication of bone tip interface for BoneScalpel hard tissue removal The active ultrasonic probe remains cold when not in contact with tissue However when a tip contacts tissue heat is generated The heat increases with applied tip pressure or amplitude Irrigant needs to be applied at the tip tissue interface to mitigate this temperature rise Most ultrasonic tips and probes feature an integrated irrigation channel The irrigant is expelled through a jet nozzle at the tip Active tip surfaces are being cooled directly BCM UM Rev H Page 26 Instructions For Use BoneScalpel with SonicOne Technology Enable Standby The Enable Standby button on the console s front panel can be used to block accidental ultrasound activation during longer periods of inactivity following set up or during surgery Standby Mode Enable Mode Amplitude setting is GREY and HOLLOW Amplitude setting is GREEN and SOLID Footswitch activates Footswitch activates o Irrigation only Irrigation can be used for o Ultrasound output and irrigation A bell chime is lavage or priming emitted briefly Table 6 1 Enable st
5. EENN 30 Zx Handpiece ASSEMDIV SESE sci asc cupuuSeeasth ep teams waimed teu Saaiee steionnte ey eine gia eonad aay anueuee enna aavenwvasdeeen tee 30 7 4 Console Set up Part II Non sterile serererererenerenenerenenenesssnananenonenonenonensnononononosnansnanananananenenane 31 Z Penor System CheCK naia 33 Handpiece Assembly And Disassembly By Application c cccssscseececsceneneneneneneneneneneuenenenenenenes 34 8 1 Handpiece Assembly HARD Tissue USC cccccseceececseceeeneaesesoneeeeeonecncaeseeoneatsesonsnsetsnsensansnees 34 8 2 Handpiece Disassembly HARD Tissue Use c cssccecseceecneaecnenecnceeonececaeenecneatsnsoneensersneensansness 36 8 3 Handpiece Assembly SOFT Tissue Use ccsccseseececseseecneatsesoneceseeonscessesnsneatsesoneensersnsensatsness 37 HA Handpiece Disassembly SOFT Tissue Use cccscesceecseeeececaceesoneaneeecnscnsaesnscneatsesoneansersueensatsnees 39 Cleaning ANG StermiZatlOn sesisiaesssincrcscvdndveccadnsacncsdavasnvasuvasdousavandeusuaveuansaunsunsiuikunisanagenddanisanddauades 41 Ode IDISASSSINDIY erter eege 41 Den EE 41 9 3 Sterilizing By Steam Autoclave ccccceeeecseeeeencenceenecnceecnecneansesoneaeeesonecesaeseeonsatsesonsnsersnsensansnees 44 94 Expected Life Reusable Components ee 45 9 5 Deviations From Decontamination Cleaning And Sterilization Instructions EE 45 Leeft Eve Ze ale EE 46 vin ll lgl CEET 49 Service Repair And Technical Corr
6. administering sterile saline with a syringe over the distal tip portion may be necessary for removal of very dense hard osseous structures of the skull when using the BoneScalpel accessories 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 main fragment remaining attached to the handpiece All fragments must be retrieved 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 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 Immediately suspend operation if Electrical Fault appears on display and or an Electrical Fault audible Indicator sounds Remove ultrasonic tip from surgical
7. malfunctions please contact Misonix or a Misonix authorized representative for service BCM UM Rev H Page 48 Instructions For Use 11 Specifications Console Specifications e 120VAC 4 Amps 60Hz e 220 VAC 2 5 Amps 50 60Hz e 230 240VAC 2 5 Amps 50Hz Operating frequency 22 5 kHz Ground leakage current 300 YA max Output power 130 Watts max Mode of Operation e Continuous Wave e Pulse Wave Controls e Mains Power on off switch rear panel Power input Footswitch control for ultrasonic and irrigation on off Ultrasound enable standby button Amplitude control Pulse control Flow control Ultrasonic timer with reset Menu button e Six screen specific buttons Irrigation pump Peristaltic pump Pump flow rate Max flow gt 67 ml min Irrigation tubing e Dedicated tubeset sterile single use e Vented IV spike compatible with fluid bags and bottles e Dedicated handpiece connection Operating conditions e Temperature 55 86 F 13 30 C Relative humidity 20 90 non condensing Standard atmospheric pressure Shipping storage conditions Temperature 35 120 F 2 49 C Relative humidity 10 95 non condensing Ambient pressure extremes 40 000 ft 14 125m Dimensions 7 Hx 16 Wx19 D 180mm H x 410 mm W x 485mm D 25 6 Lb 11 6 kg Table 11 1 Console specifications BCM UM Rev H BoneScalpel with SonicOne Technology Page 49 Instructions For Use BoneScalpel with SonicOne Technology
8. on the supplier and you the purchaser 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 be obtained from your local council Your role is critical and will help to ensure the Earth s resources are maintained and that as much re useable and recyclable material as possible is processed It will also ensure that the landfill volume requirements are kept at a minimum and that hazardous materials are not buried thereby providing potential future problems for the environmental and human health Table 1 6 Envir
9. site Turn Mains Power OFF Do not touch any metallic parts of handpiece extension ultrasonic tip or generator while fault is indicated Improper connection of the handpiece cable may present a shock hazard Confirm that handpiece connector is dry prior to plugging it in 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 Tip and irrigation temperatures may exceed the tissue necrosis point with BoneScalpel 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 comparable vibration setting For example if the vibration setting is 7 a minimum flow setting of 70 should be used Page 8 Instructions For Use WARNING 7 4 WARNING 8 1 WARNING 9 1 WARNING 9 2 WARNING 9 3 WARNING 10 1 WARNING 12 1 BoneScalpel with SonicOne Technology 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 Remove probe cover ultrasonic tip and extension from the handpiece prior to cleaning and or sterilization otherwise proper cleaning sterilization may be inhibited Single u
10. 120 VAC 60 Hz Cooper Bussman GDB 4 250V 4A Fast Acting Low Breaking 220 230 240 VAC 50 60 Hz Littlefuse 021702 5 250V 2 5A Fast Acting Table 12 1 Console fuse specifications Fuse Replacement The fuse holder is located on the console rear Disable Ultrasound Switch to Standby Mode using 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 power cord and switch console ON Confirm that console powers up and that Main Settings respond to activation of buttons A F Table 12 2 Fuse replacement BCM UM Rev H Page 51 Instructions For Use BoneScalpel with SonicOne Technology 12 2 Pump Head Replacement The pump head may not be connected to the unit for shipping purposes Mount Pump Head Shaft recess and bayonet fitting on pump Pump drive shaft on console front head rear Position Pump Head D Align drive shaft on console front and shaft recess on pump head rear Drive shaft and recess must engage easily Rotate pump head slightly back and forth to check engagement Turn pump head 45 clockwise Lock pump head in place Turn pump head clockwise until it locks in place Arrow should be in the vertical position po
11. BoneScalpel System With SonicOne Technology Instructions For Use Model BCM SY MISONIX LTRASONIC SURGICAL DEVICES Instructions For Use BoneScalpel with SonicOne Technology BCM UM Rev H Page 1 Instructions For Use BoneScalpel with SonicOne Technology Table of Contents 1 10 11 12 GeNeral Setbebv G Eat H EEeieeseege eege ee See EEN NNUA AAA NIADA ESAn Nia 3 LE E e un En E 3 L2 ege sate Ee ne 6 E332 Environmental stake MCI cerron rE E NE 6 LA SuUMMary Of Safely INOUCCS eege 7 ke Hademak IMIGEMN ALON ee EE eet 10 LG EE REH EE eege eege 11 Indications And Contra Indications scscscscscscseecseneseseseseseeeueeeeeeeeeeeeeeeeeeeeeeseseeueueuauauaeauaeneaeaeaeneas 12 2il ue eg Lee esseccan evecare EE E 12 Z2 OME E Ia el ege EEN 12 AIVE SE en aerar ceuscsevesusceessaustaeseusaiaessavasaesavasaessauaveusuasaseaiaes 13 Considerations During Clinical USC sssssssssnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnan 14 fde AARD PISSUC USE enee A 15 e GER EE 16 System EINEN Mee 17 Sle le elle OF ODel ee EE 17 5 2 REU aD SV en EIDEN ee 18 5 5 SMdle use Sterile Comnen EE 19 Ee ege ee ee ee ege ee eege ee ege 22 Gil Receptacles Controls ANG ln el ere CN 22 62e Ment FUNCUONS ee EE 23 SE MaM Dinge E 25 Ost E EC AG Rate le 27 System SOUHUD ossaa a a E 29 Fale du eg e E 29 7 2 Console Set up Part I ONGon Senl IegusegedgegekdugeE Eed ek C ENNEN ONE Nee eege
12. MISONIX COM NASDAQ SYMBOL MSON BCM UM Rev H Page 55 L gt ab cc gt gt O m x Be 5 S O oO lt Kei ab Z ab V D n Be D x S x C O D gt CH CH CN
13. Rev H Handpiece assembly for soft tissue use Handpiece Assembly SOFT Tissue Use Turn clockwise Turn clockwise Turn clockwise Page 38 Instructions For Use BoneScalpel with SonicOne Technology Figure 8 2 Fully assembled handpiece for soft tissue use The handpiece is now ready for use and can now be connected to the BoneScalpel 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 handpiece cable 8 4 Handpiece Disassembly SOFT Tissue Use 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 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 T 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 the extension 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 4 Always hold the handpiece at its metallic endcap when tightening or un tightening the irrigation tubing Always tighten or un tighten the irrigation tubing by hand and without using any wrenches Do not over tighten
14. al 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 The BoneScalpel 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 The BoneScalpel 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 Proper system grounding can only be ensured when an approved hospital grade receptacle and matching power cord are used Install plug and receptacles 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 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 on the console rear panel is
15. andby function 6 4 Alerts And Indicators Mechanical Limit Alert The console monitors the ultrasonic output at all times and alerts in cases of overload or malfunction of the vibrating elements handpiece extension and ultrasonic tip A Limit alert is displayed together with a pulsed audible indicator as long as the footswitch is depressed Ultrasound and Irrigation are deactivated temporarily Mechanical Limit Alert Mechanical Limit Displays LIMIT alert located above amplitude setting display Triggers a pulsed audible indicator upon footswitch activation Temporarily deactivates ultrasound and irrigation functions Possible Cause Corrective Action 1 Tip overload Release footswitch Reduce tip pressure and or use higher amplitude setting as required Continue procedure 2 Loose or Release footswitch damaged component Set ultrasound to STANDBY Remove silicone sleeve if applicable and probe cover Inspect extension probe and ultrasonic tip for damage Replace if necessary Otherwise re tighten extension probe and tip using the correct wrenches Set ultrasound to ENABLE BCM UM Rev H Page 27 Instructions For Use BoneScalpel with SonicOne Technology 3 Defective Handpiece If corrective action steps above are followed and alert continues the handpiece may need to be replaced Table 6 2 Mechanical limit alert and recommended corrective actions Tip overload can occur during hard tissue r
16. andpiece and all components prior assembly Handpiece Inspection Inspect Inspect the black handpiece housing for any visual cracks Inspect the front metallic portion Handpiece probe for surface damage like nicks gouges and cracks Replace if damaged Inspect Inspect mating face of handpiece to verify that it is clean and dry Mating Surface Table 8 1 Handpiece inspection CAUTION 8 1 Ensure all connections and mating surfaces of handpiece extension and ultrasonic tip are clean and dry before assembly 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 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 T 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 the extension 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 or un tighten the irrigation tubing by hand and without using any wre
17. andpiece has been assembled continue with part IT of the Console Set Up BCM UM Rev H Page 30 Instructions For Use BoneScalpel with SonicOne Technology 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 7 4 Console Set up Part II Non sterile Console Set up Part II Connect Attach cable connector receptacle on console front panel Handpiece cable Align red dot on cable connector with red dot on front panel receptacle Push cable connector into place Open pump cover Open the latch of the irrigation pump Insert tubing Insert the soft silicone section by placing it over the pump rollers Verify that the tubing enters the pump from fluid container and exits to handpiece and in direction of arrow on pump housing Secure tubing in Place and hold the tubing s silicone section in the V notches on both pump sides V notches Apply slight pressure to ensure that tubing rests wi
18. arp debridement The BoneScalpel system to be operated by surgeons physicians justified to practice in the fields covered by the stated indications for use CAUTION 1 1 Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner 2 2 Contra Indications The BoneScalpel system is contra indicated for cardiac surgery and any procedure in the proximity of the heart The irrigation pump is contra indicated for the administration of parenteral fluids infusion of drugs or for any life sustaining purposes BCM UM Rev H Page 12 Instructions For Use BoneScalpel with SonicOne Technology 3 Adverse Effects CAUTION 3 1 WARNING 3 1 WARNING 3 2 BCM UM Rev H The BoneScalpel system and its accessories may emit harmful acoustic pressure if exposure exceeds recommended limits Limits For Airborn Acoustic Exposure Distance from operator s Maximum Exposure Period or patient s ear Within a 24 hour period 28 minutes 287 minutes Tip and irrigant temperatures may exceed the tissue necrosis point if insufficient 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 by administering sterile saline with a syringe over the distal tip portion may be necessary for removal of very d
19. ded corrective actions Tip overload can occur during hard tissue removal when applying excessive tip pressure or facing strong tissue resistance e g from thick cortical bone This can lead to stalling of the ultrasonic tip A pulsed audible signal alerts of the stalling and the ultrasound is deactivated 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 BCM UM Rev H Page 46 Instructions For Use BoneScalpel with SonicOne Technology Electrical Fault Alert Alert Type Alert Screen Alert Action Electrical Fault Displays Electrical Fault Screen Triggers steady audible indicator Permanently deactivates ultrasound and irrigation Requires recycling of mains power switch to re set Possible Cause Corrective Action 1 Handpiece not Turn console OFF connected Check handpiece cable connection Restart console 2 Defective Turn console OFF Handpiece Replace handpiece and restart console If problem persists replace console 3 Defective console Turn console OFF Replace console Table 6 3 Electrical fault alert and recommended corrective actions 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 Ma
20. e 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 Contact of the 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 and may result in compromised performance including failure Discard any extensions or tips 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 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 foam or other 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 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 T wrench wrench when tightening or un tightenin
21. e 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 operating conditions Operating Conditions Operating conditions e Temperature 55 86 F 13 30 C e Relative humidity 20 90 non condensing e Standard atmospheric pressure Table 7 1 Operating conditions The console can be placed on an appropriate table or cart outside of the sterile field Ensure that the pump head on the console right is installed Refer to section 12 2 if the pump head is not yet installed Adjust the grip Evenly adjust the V notches to their fully opened position by turning the adjustment wheels of the V notches BCM UM Rev H Page 29 Instructions For Use BoneScalpel with SonicOne Technology The console features air vents on the bottom When installing the unit ensure that these vents are not blocked in a way that would prevent the circulation of air around the unit Figure 7 1 1 Air vents Underside view 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 foam or other soft surface since the material may block the air vents Blocking these v
22. e touch This is normal Do not touch the bottom of the console housing while in operation or shortly after operation 4 2 HARD Tissue Use Recommended Settings For Hard Tissue Use The following settings are general guidelines and should be adjusted based on indication anatomy pathology and surgeon s preference Amplitude Pulse Flow Very Higa 9 100 0 Higa 8 mme 8 Standard Default 100 Moderate _ _ 6 100 100 Table 4 1 Recommended settings for hard tissue removal e Ahigh amplitude setting results in more aggressive tissue removal a low setting in less aggressive tissue removal e A higher amplitude setting in combination with lower irrigation could result in increased tissue necrosis A lower amplitude setting in combination with higher irrigation would minimize or eliminate tissue necrosis e Bone shaving tips tend to require a lower amplitude than cutting blades WARNING 3 1 Tip and irrigant temperatures may exceed the tissue necrosis point if insufficient 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 by administering 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
23. emoval when applying excessive tip pressure or facing strong tissue resistance e g from thick cortical bone This can lead to stalling of the ultrasonic tip A pulsed audible signal alerts of the stalling and the ultrasound is deactivated 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 The console monitors the electrical output at all times and alerts in cases where the handpiece is not properly connected to the console when an output short or open circuit is detected or electrical safety is compromised An Electrical Fault Screen 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 ultrasonic tip or generator while fault is indicated Electrical Fault Alert Alert Type Alert Screen Alert Action Electrical Fault Displays Electrical Fault Screen Triggers steady audible indicator Permanently deactivates ultrasound and irrigation Requires recycling of mains power switch to re
24. ense hard osseous structures 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 Page 13 Instructions For Use BoneScalpel with SonicOne Technology 4 Considerations During Clinical Use 4 1 Hand position Recommended Hand Positions The following illustrations demonstrate safe positions for holding the handpiece Figure 4 1 Correct hand position Holding the handpiece at the silicone sleeve should be avoided or kept brief with minimal amount of contact pressure Figure 4 2 Incorrect hand position BCM UM Rev H Page 14 Instructions For Use BoneScalpel with SonicOne Technology 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 th
25. ents 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 7 2 Console Set up Part I Non sterile Switch Mains Power OFF Connect IV pole Connect Electrical Power Connect Footswitch Switch Mains Power ON Set Mains Power switch on console rear to OFF Connect IV pole to 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 Connect power cord to receptacle on console rear and to wall outlet Connect footswitch cable to receptacle 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 Set Mains Power switch on console rear to ON Front panel will display Main Screen upon completion of system start Table 7 2 Console set up part I 7 3 Handpiece Assembly Sterile Handpiece assembly in the sterile field should be performed by trained and authorized OR staff only Please refer to section 8 0 for specifics on the handpiece assembly and disassembly for both hard and soft tissue applications Once the h
26. espondence scccseseseseseeeeeeeeseeeeeseeeeeeeeeeeeeeeeeeeeeaeeeaeseseeneaeas 51 LZ FUSE el E Le NET EE 51 Een POM Head EU EE 52 12755 ReDalr Service and Replacement Tu 52 124 AMMDORCANE e Le 53 BCM UM Rev H Page 2 Instructions For Use BoneScalpel with SonicOne Technology 1 General Safety Statements WARNING 1 1 The BoneScalpel 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 BoneScalpel 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 Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner 1 1 EMC Statement The BoneScalpel 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 CAUTION 1 2 This device is considered medical electrical equipment Medical electrical equipment needs special precautions regarding electromagnetic compatib
27. eting Instructions for Use connection Disposal to be dr Flow setting Type B equipment ls Ger directive Restricted to sale Do not reuse zee uang by or on the order Ethylene Oxide y SEN of a physician only Do not use if packaging is damaged Amplitude setting Sterilized using Authorized Gamma Irradiation representative Contents are latex free Use by date indicated Catalog number Lot or batch code AC Voltage Footswitch connector Do not expose to temperatures greater than indicated Must use hospital grade power cord only Misonix CE number Classified by UL BCM UM Rev H Page 11 Instructions For Use BoneScalpel with SonicOne Technology Contains DEHP and or Phthalates Table 1 8 Explanation of symbols 2 Indications And Contra Indications 2 1 Indications The BoneScalpel system is indicated for use in the fragmentation and aspiration of both soft and hard e g bone tissue as used in the following surgical specialties Orthopedic Surgery Plastic and Reconstructive Surgery Thoracic Surgery NeuroSurgery Wound Care General Surgery It is also indicated for use in debridement of wounds such as but not limited to burn wounds diabetic ulcers bedsores and vaginal ulcers soft tissue debridement and cleansing of the surgical site in application in which in the physician s judgment would require the use of an ultrasonic aspirator with sh
28. g the tip or an extension Never apply a pipe or strap wrench to the handpiece case Do not over tighten the tip or the extension Always tighten or un tighten the probe cover by hand and without using any wrenches Do not over tighten the probe cover Always hold the handpiece at its metallic endcap when tightening or un tightening the irrigation tubing Always tighten or un tighten the irrigation tubing by hand and without using any wrenches Do not over tighten the tubing connector Allow reusable autoclavable items to gradually return to room temperature after steam sterilization and prior to usage 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 BoneScalpel is a pending trademark of Misonix Inc Farmingdale NY ASP Enzol and Prolystica are registered trademarks of STERIS Corporation Mentor OH BCM UM Rev H Page 10 Instructions For Use BoneScalpel with SonicOne Technology 1 6 Explanation Of Symbols Console Related Symbols Enable Standby Caution Ultrasound Dangerous voltage Mains Power ON Scroll through Caution Consult accompanying Mains Power OFF menu pages documents Caution Protective Pinch hazard earth ground Consult Equipotentiality PUSE S
29. gments 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 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 Insufficient irrigation and high tip pressure loading under extended exposure e g in tight cavities are to be avoided in BoneScalpel hard tissue removal It is recommended to withdraw and re insert the ultrasonic tip repeatedly to re establish adequate cooling and lubrication 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 Contact of the ultrasonic tip or the exposed extension with metal surgical instruments or other objects du
30. ic tips are supplied sterile and are for single use only At least one of the following tips must be available for each surgical procedure Hard Tissue Tips MXB 10 Bone Scalpel 10mm Blunt Requires R EE BCM SS Wi probe cover Includes blade short extension and silicone sleeve MXB 20 Bone Scalpel 20mm Blunt Requires KS eee BCM SS 2 eI r uL gt probe cover Includes blade short extension and silicone sleeve MXB B1 Bone Scalpel 20mm Unilateral Serrations Requires DE p Gg SC BCM SS E DO USS ae probe cover Includes blade short extension and silicone sleeve MXB B30 Bone Scalpel 30mm Unilateral Serrations Requires ee wt BCM SS HE a probe cover Includes blade short extension and silicone sleeve MXB S1 Bone Shaver Micro Hook Requires eee BCM SS a LR 00999 probe cover Includes shaver tip short extension and silicone sleeve BCM UM Rev H Page 19 Instructions For Use MXB S3 Bone Shaver 04 4mm Diamond Includes shaver tip and silicone sleeve MXB 10LS Bone Scalpel 10mm Blunt Long Straight MXB 10LC Table 5 3 Hard tissue tips Soft Tissue Tips For small tunneling wounds Hatched Titanium Tip OI CCS For aggressive debridement of soft and hard tissue Curette Style Titanium Tip For general debridement and wound edge removal Table 5 4 Soft tissue tips
31. icOne Technology 5 2 Reusable System Components The following system components represent the minimum requirements for performing hard and soft tissue procedures They can be ordered as a system or individually Required System Components BCM GN BoneScalpel console 1 ea Includes IV pole power cord footswitch peristaltic pump and instructions for use BCM HP BoneScalpel handpiece universal for hard and soft tissue applications 1 ea BCM CW Counter wrench for BoneScalpel handpiece Compatible with 1 ea BCM HP b C BCM BW T Wrench for hard and soft tissue tips Compatible with MXB 10 MXB 20 MXB B1 MXB B30 2 MXB S1 e rm MXB S3 nd MXB 10LC MXB 10LS MXB 20LC MXC C1 MXC R1 MXC X1 BCM SS Probe cover for hard tissue tips Compatible with MXB 10 wi MXB 20 Mf i MXB B1 SE e MXB B30 A Ge MXB S1 Wi MXB S3 MXB 10LC MXB 10LS MXB 20LC BCM UM Rev H Page 18 Instructions For Use BoneScalpel with SonicOne Technology Probe cover for soft tissue tips Compatible with MXB C1 MXB R1 MXB X1 Table 5 1 Required system components Components and quantities included with the system may change over time please check with your Misonix representative for the most current configuration 5 3 Single use Sterile Components At least one irrigation tubeset must be available for each surgical procedure Irrigation Tubeset MXB T Irrigation Tubeset Table 5 2 Irrigation tubeset Ultrason
32. icts this device to sale by or on the order of a 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 put into service according to the EMC information provided in this operator s manual CAUTION 1 3 Portable and mobile RF communication equipment can affect medical electrical equipment If RF equipment is in use monitor the Bonescalpel 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 be observed to verify normal operation in the configuration in which it will be used CAUTION 3 1 The BoneScalpel system and its accessories may emit harmful acoustic pressure if exposure exceeds recommended limits 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
33. ility 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 mobile RF communication equipment can affect medical electrical equipment If RF equipment is in use monitor the BoneScalpel 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 be observed to verify normal operation in the configuration in which it will be used Electromagnetic Compatibility Guidance in accordance with EN IEC 60601 1 2 2007 Guidance And Manufacturer s Declaration Electromagnetic Emissions Tabie 201 The BONESCALPEL SYSTEM is intended for use in the electromagnetic environment specified below The customer or the user of BONESCALPEL SYSTEM should ensure that it is used in such an environment The BONESCALPEL SYSTEM uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely CISPR 11 to cause any interference in nearby electronic equipment RF emissions RF emission Bee Class A CISPR 11 Lee The BONESCALPEL SYSTEM is suitable for use in all establishments Harmonic emiss
34. imum output power of the communications equipment D M mn f R Rated maximum output Separation distance a to frequency of transmitter power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 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 Pis 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 and people Table 1 5 Recommended separation distances EN table 206 1 2 Electrical Safety Statement The BoneScalpel System is designed and tested to comply with UL 60601 1 and EN 60601 1 WARNING 1 3 The BoneScalpel 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 syste
35. ins Power OFF Do not touch any metallic parts of handpiece extension ultrasonic tip or generator while fault is indicated 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 with protective earth Install plug and receptacles 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 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 BCM UM Rev H Page 47 Instructions For Use BoneScalpel with SonicOne Technology Lack of Irrigant Symptoms e No spray from tip when ultrasound is engaged e No flush fluid available e Unexpected temperature rise at operative site e Unexpected temperature rise of handpiece Alert Type Alert Screen Alert Action Possible Cause Ultrasound Mode Corrective Action 1 Closed or Set ultrasound to STANDBY Check fluid bag and tubing clamp Replace fluid bag if empty fluid bag necessary 2 Tubing not Set ultrasound to STANDBY Check tubing connections connected Check mounting in pump head Close pump cover until locked 3 Tubing Set u
36. inting down Table 12 3 Assembly of pump head Remove Pump Head Disable Ultrasound Switch to Standby Mode using 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 pump cover Release Pump Head Press and hold lock lever on pump head bottom Turn pump head 45 counter clockwise Remove pump head Pull pump head away from console until pump drive shaft clears Release lock lever Table 12 4 Disassembly of pump head 12 3 Repair Service and Replacement Parts All requests for repairs and replacement parts should be directed to Misonix or an authorized Misonix representative Always provide model and serial number of malfunctioning items When returning items include model serial and RMA number as well as purchase order number on all documents Always prepay return shipping and specify method of shipment BCM UM Rev H Page 52 Instructions For Use BoneScalpel with SonicOne Technology 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 wrap
37. ions Class A other than domestic and those directly connected to the public low IEC 61000 3 2 voltage power supply network that supplies buildings used for Voltage fluctuations domestic purposes flicker emissions Complies IEC 61000 3 3 Table 1 1 Guidance amp manufacturer s declaration on electromagnetic emissions EN table 201 BCM UM Rev H Page 3 Instructions For Use BoneScalpel with SonicOne Technology Guidance And Manufacturer s Declaration Electromagnetic Immunity Tabie 202 The BONESCALPEL SYSTEM is intended for use in the electromagnetic environment specified below The customer or the user of the BONESCALPEL SYSTEM should assure that it is used in such an environment IEC 60601 S Electromagnetic environment Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 NOTE Table 1 2 Handpiece cable Power cord Footswitch cable Table 1 3 BCM UM Rev H o 6 kV contact o 8 KV air o 2 kV for power Supply lines O 1 kV for input output lines o 1 kV differential mode O 2 kV common mode lt 5 UL gt 95 dip in 4 for 0 5 cycle 40 Ur 60 dip in U4 for 5 cycles 70 U 30 dip in U4 for 25 cycles lt 5 UL gt 95 d
38. ip in 4 for 5 sec List of cables o 6 kV contact o 8 KV air o 2 kV for power supply lines o 1 kV for input output lines o 1 kV differential mode o 2 kV common mode lt 5 Ur gt 95 dip in 4 for 0 5 cycle 40 UY 60 dip in U4 for 5 cycles 70 Ur 30 dip in 4 for 25 cycles lt 5 Ur gt 95 dip in 4 for 5 sec U is the AC mains voltage prior to application of the test level List of Cables Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the BONESCALPEL SYSTEM requires continued operation during power mains interruptions it is recommended that the powered from an uninterruptible power Supply Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Guidance amp manufacturer s declaration on electromagnetic immunity EN table 202 Type shielded 2 conductor unshielded 3 conducter shielded 2 conductor Page 4 Instructions For Use BoneScalpel with SonicOne Technology Guidance And Manufacturer s Declaration Electr
39. l 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 Clean And Disinfect Sterilize Reusable Items The following items are considered reusable items and should be cleaned as recommended Handpiece Counter wrench T wrench Probe covers for soft and hard tissue applications Probe Cover and Wrenches Wash amp Brush e Wash items with hot water mixed with an enzymatic detergent such as ASP Enzol or Steris Prolystica according to standard hospital protocol Follow manufacturer s directions for preparing solutions e Probe cover and wrenches may be fully immersed e Brush all passages at least four 4 times from FRONT to REAR rotating the brushes during insertion and inserting the brushes fully This ensures clearing of debris from the internal passages e Item s exterior surface can be cleaned using a standard soft bristle cleaning brush Rinse e Rinse item under warm running water for a minimum of 1 minute to clear soap residue e Dry item fully with absorbent towel or paper Dispose of cloth or paper in accordance with Hospital or Clinic practices for contaminated wastes Table 9 2 Cleaning of probe cover and wrenches Handpiece Wipe Cable e Wipe cable with cloth or absorbent paper moistened with an enzymatic deterge
40. ltrasound to STANDBY Check tubing for kinking restrictions or leaks Replace tubing obstructed or if necessary defective Check mounting in pump head Close pump cover until locked 4 Tubing installed Set ultrasound to STANDBY Open pump cover Reposition the tubing in direction of flow in reverse Close pump cover until locked 5 Tubing slides Set ultrasound to STANDBY Open pump cover Adjust the grip of the tubing by turning through pump the adjustment wheel underneath the front and back of the pump assembly 6 Pump defect Set ultrasound to STANDBY Open pump cover Check if pump rollers are rotating when depressing footswitch Replace console if they don t Table 10 1 Troubleshooting Insufficient Irrigation WARNING 3 1 Tip and irrigant temperatures may exceed the tissue necrosis point if insufficient 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 WARNING 7 1 Improper connection of the 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 For all other
41. m 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 with protective earth Install plug and receptacles 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 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 local voltage setting and ensure that the correct fuses are being used Refer to section 12 1 on instructions for fuse replacement 1 3 Environmental Statement This equipment consists of materials that may be recycled if disassembled by a specialized company Please observe local and federal regulations regarding the disposal of packing materials and old equipment BCM UM Rev H Page 6 Instructions For Use BoneScalpel with SonicOne Technology 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 electronic equipment The regulations called Directives place responsibilities
42. 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 4 2 Additional external irrigation e g by administering sterile saline with a syringe over the distal tip portion may be necessary for removal of very dense hard osseous structures of the skull when using the BoneScalpel accessories 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 BCM UM Rev H Page 15 Instructions For Use BoneScalpel with SonicOne Technology Tip Limitations During Bone Removal Both the ultrasonic tip and the extension are vibrating at high frequency and are thus exposed to extreme mechanical stresses especially when cutting bone WARNING 4 3 WARNING 4 4 CAUTION 4 2 NOTE 4 2 NOTE 4 3 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 main fragment remaining attached to the handpiece All fragments must be retrieved immediately from the surgical site The fra
43. nch 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 the extension 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 or un tighten the irrigation tubing by hand and without using any wrenches Do not over tighten the tubing connector Handpiece Disassembly post Hard Tissue Use Disconnect Irrigation Tubing Turn counter clockwise Remove A Sheath 7 Pull sheath from probe cover BCM UM Rev H Page 36 Instructions For Use BoneScalpel with SonicOne Technology Remove Probe Cover Mount Handpiece Wrench Mount Tip Wrench Remove Ultrasonic Tip l a Table 8 3 Handpiece disassembly post hard tissue use 8 3 Handpiece Assembly SOFT Tissue Use Perform an inspection of all handpiece components prior assembly Handpiece Inspection Inspect Inspect the black handpiece housing for any visual cracks Inspect the front metallic portion Handpiece probe for surface damages like nicks gouges and cracks Replace if damaged Inspect Inspect mating face of handpiece to verify that it is clean and dry Mating Surface Table 8 4 Handpiece inspection Perform an inspection of all handpiece com
44. nches Do not over tighten the tubing connector Handpiece Assembly HARD Tissue Use Mount e e Handpiece Wrench NE Mount SF Extension Turn clockwise BCM UM Rev H Page 34 Instructions For Use Tighten Extension Mount Ultrasonic Tip Mount Tip Wrench Tighten Ultrasonic Tip Mount Probe Cover Mount Sleeve if applicable Connect Irrigation Tubing Table 8 2 Handpiece assembly for hard tissue use SS SC N di TI Le R Le Ds e ANI D SN pe Tighten clockwise Turn clockwise BoneScalpel with SonicOne Technology Turn clockwise Turn clockwise Push sleeve over probe cover The handpiece is now ready for use and can be connected to the BoneScalpel System Please refer to Section 7 0 for details BCM UM Rev H Page 35 Instructions For Use BoneScalpel with SonicOne Technology Figure 8 1 Fully assembled handpiece for hard tissue use If desired mount suitable sterile cable clips or sterile adhesive tape strips to attach irrigation tubing to handpiece cable 8 2 Handpiece Disassembly HARD Tissue Use 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 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 T wrench wre
45. nd 3 can be accessed by pressing either C or D Contrast The display contrast can be adjusted Press E to increase and F to decrease contrast Pressing the menu button toggles from the options to the help screen BCM UM Rev H Page 24 Instructions For Use BoneScalpel with SonicOne Technology Help Screen The Help Screen provides access to a quick guide on system operation and troubleshooting HELP MENU A SYSTEM OPERATION 1 Menu Button 2 Software Revision 1 x PRESS MENU A F Custom Buttons MAIN SCREEN B TROUBLESHOOTING Figure 6 5 Help screen System Operation Press A to access the quick reference guide on system operation Troubleshooting Press B to access the quick reference guide on troubleshooting The software revision may be found in the upper right corner of this screen Pressing the menu button toggles from the help to the main screen 6 3 Main Functions Amplitude The ultrasonic tip engages the target area in linear strokes at a rate of approximately 22 500 cycles per second During each cycle the tip elongates from resting to maximum position contracts back over resting and to minimum position and elongates 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 aggressive tissue removal a low setting in less aggre
46. nd menu access are provided on the left of the display panel An ultrasound timer indicates the elapsed time in which the ultrasound was on Amplitude setting Pulse setting Flow setting Enable standby button Ultrasound timer Menu button Handpiece cable receptacle Indicator for flow direction Irrigation pump head F Custom buttons IMISONIX BoneScalpel ireo Suya Corede Pv OO zl On Om P WN r Figure 6 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 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 BCM UM Rev H Page 22 Instructions For Use BoneScalpel with SonicOne Technology 6 2 Menu Functions The standard screen is the Main Screen Additional screens are the Options and the Help Screen Both the Options and Help screens can be accessed by pressing the menu button to toggle through the three main screens Main Menu Options and Help Main Screen The Main Screen allows control of the main system functions such as Amplitude Pulse and Flow 1 Menu Button A F Custom Buttons Figure 6 3 Main screen Amplitude Control The amplitude can be set between 0 and 10 Press A to increase and B to decrease the amplitude The default setting for am
47. ngths 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 BONESCALPEL SYSTEM is used exceeds the applicable RF compliance level above the BONESCALPEL 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 BONESCALPEL SYSTEM Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Table 1 4 Guidance amp manufacturer s declaration on electromagnetic immunity EN table 204 BCM UM Rev H Page 5 Instructions For Use BoneScalpel with SonicOne Technology Recommended Separation Distances Between Portable And Mobile RF Communications Equipment And The BONESCALPEL SYSTEM rabe 206 The BONESCALPEL SYSTEM is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the BONESCALPEL SYSTEM can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the BONESCALPEL SYSTEM below according to the max
48. nstructions For Use BoneScalpel with SonicOne Technology CAUTION 8 1 CAUTION 9 1 CAUTION 9 2 CAUTION 9 3 CAUTION 12 1 CAUTION 12 2 List Of Notes NOTE 4 1 NOTE 4 2 NOTE 4 3 NOTE 7 1 NOTE 8 1 NOTE 8 2 NOTE 8 3 NOTE 9 1 NOTE 9 2 Ensure all connections and mating surfaces of handpiece extension and ultrasonic tip are clean and dry before assembly Use manual cleaning techniques only Do not use ultrasonic cleaners or automated washers to clean the handpiece as both methods could damage handpiece Be certain to clear debris from all internal passages by brushing Failure to do so may hinder sterilization of units during autoclaving 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 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 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 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 Loose tip tissu
49. nt such as ASP Enzol or Steris Prolystica Follow manufacturer s directions for preparing solutions Clean all surfaces of bloodstains and obvious signs of contamination Wash amp Brush Wash and brush handpiece item with hot water mixed with an enzymatic detergent such as ASP Enzol or Steris Prolystica Follow manufacturer s directions for preparing solutions The handpiece cannot be immersed Brush all passages at least four 4 times from FRONT to REAR rotating the brushes during insertion and inserting the brushes fully This insures clearing of debris from the internal passages The item s exterior surface can be cleaned using a standard soft bristle cleaning brush e Rinse item under warm running water for a minimum of 1 minute to clear soap residue Dry e Dry item fully with absorbent towel or paper Dispose of cloth or paper in accordance with Hospital or Clinic practices for contaminated wastes e Inspect handpiece and cable and remove any item which shows signs of damages cracks gouges fractures etc Mark damaged items clearly to prevent future use before disposal Table 9 3 Cleaning of handpiece BCM UM Rev H Page 43 Instructions For Use BoneScalpel with SonicOne Technology CAUTION 9 1 Use manual cleaning techniques only Do not use ultrasonic cleaners or automated washers to clean the handpiece as both methods could damage handpiece CAUTION 9 2 Be certain to clear debris from all internal passage
50. omagnetic Immunity Tabie 204 The the BONESCALPEL SYSTEM is intended for use in the electromagnetic environment specified below The customer or user of the BONESCALPEL SYSTEM should assure that it is used in such an environment Immunity test ES reid vesi SE Electromagnetic environment guidance Con IEC Rad IEC Portable and mobile RF communications equipment should be used no closer to any part of the BONESCALPEL SYSTEM including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2JP ducted RF 3 Vrms 61000 4 6 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz iated RF 3 V m d 2 3 P 800 MHz to 2 5 GHz 61000 4 3 80 MHz to 2 5 GHz where Pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and dis the recommended separation distance in meters m Field strengths from fixed RF transmitters as deter mined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Del 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 and people Field stre
51. onmental statement 1 4 Summary Of Safety Notices 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 of this device should only be performed by qualified technicians authorized by Misonix Inc There are no service controls accessible to the user Conventions on Warnings Cautions and Notes 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 Table 1 7 Conventions on warnings cautions and notes BCM UM Rev H Page 7 Instructions For Use BoneScalpel with SonicOne Technology List Of Warnings WARNING 1 1 WARNING 1 2 WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING 1 3 1 4 1 5 3 1 3 2 4 1 4 2 4 3 4 4 6 1 7 1 7 2 7 3 BCM UM Rev H The BoneScalpel system is an electro mechanical device which under certain circumstances could present an electrical shock hazard to the operator and or patient Please read manu
52. onsole Figure 5 2 BoneScalpel Handpiece The console produces an electrical signal that is fed into the handpiece and its piezoelectric transducer The transducer converts the electrical signal into mechanical vibrations The vibratory motion is amplified all the way down to the tip s distal end Various tip shapes and sizes are available to achieve desired tissue effects Hard Tissue Applications Specialized hard tissue tips are utilized to cut hard osseous structures o BoneScalpel blades typically used for performing osteotomies 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 Bone shaving tips are used for sculpting bone They have an abrasive surface for bone removal through abrasion under ultrasonic oscillation o BoneScalpel multi function tips can have a combination of blunt and abrasive cutting surfaces s Soft Tissue Applications Specialized soft tissue tips are utilized to cut and fragment soft tissue structures SonicOne technology o Debridement tips are typically used for contact wound debridement Tissue excision and fragmentation are achieved through cavitation and other mechanical and hydrodynamic effects A peristaltic pump integrated into the BoneScalpel console provides irrigant sterile physiological saline to the operative site during use BCM UM Rev H Page 17 Instructions For Use BoneScalpel with Son
53. ping 12 4 Important Notice Please contact Misonix with any questions regarding the specifications use sterilization limitations or maintenance of the BoneScalpel System Misonix Inc Web www misonix com Email Sales misonix com Phone 1 631 694 9555 1 800 694 9612 Fax 1 631 694 9412 Address 1938 New Highway Farmingdale NY 11735 U S A By returning any material to Misonix Inc the customer or the customer s agent must 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 Department RMA 1938 New Highway Farmingdale New York 11735 U S A Please contact Misonix for a list of other authorized service centers The authorized EC representative is EC REP C Misonix Ltd The Barn Manor Farm Church Lane Chilcompton Somerset BA3 4HP United Kingdom BCM UM Rev H Page 53 Instructions For Use BoneScalpel with SonicOne Technology BCM UM Rev H Page 54 Instructions For Use BoneScalpel with SonicOne Technology MISONIX ULTRASONIC SURGICAL DEVICES 1 631 694 9555 phone 1 631 694 3285 fax 1938 New Highway Farmingdale N Y 11735 U S A
54. plitude 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 The default setting for pulse is 100 Refer to section 6 3 for further details on the Pulse feature Flow Control The flow can be set between 20 and 100 Press E to increase and F to decrease the flow The default setting is 70 Refer to section 6 3 for further details on the Flow feature Ultrasound Timer The ultrasound timer records the elapsed 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 BCM UM Rev H Page 23 Instructions For Use BoneScalpel with SonicOne Technology Options Screen The Options Screen allows the user to do the following re set the elapsed ultrasound time save and choose presets and adjust the display contrast 1 Menu Button A F Custom Buttons A B C D E F Figure 6 4 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 can not be customized A sub screen for presets 1 2 a
55. ponents prior assembly CAUTION 8 1 CAUTION 7 2 CAUTION 7 3 NOTE 8 1 BCM UM Rev H Ensure all connections and mating surfaces of handpiece extension and ultrasonic tip are clean and dry before assembly All items intended for use in the sterile field must be cleaned and sterilized as per indicated instructions before each clinical use The disposable items are intended for one procedure only single use Do not attempt to reuse or re sterilize 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 T 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 the extension Page 37 BoneScalpel with SonicOne Technology Always tighten or un tighten the probe cover by hand and without using any wrenches Do not over tighten the probe Instructions For Use NOTE 8 2 cover NOTE 8 3 Always hold the handpiece at its metallic endcap when tightening or un tightening the irrigation tubing Always tighten or un tighten the irrigation tubing by hand and without using any wrenches Do not over tighten the tubing connector Mount Handpiece Wrench Align wrench flats Mount Ultrasonic Tip Tighten Ultrasonic Tip Tighten clockwise Mount 8 Probe Cover x Connect Irrigation Tubing Table 8 5 BCM UM
56. ress footswitch Direct ultrasonic tip toward suitable reservoir to collect irrigant Depress footswitch Confirm Function Console emits a bell chime Irrigant will be pumped from console towards handpiece Ultrasonic tip emits buzzing sound and irrigant exits tip as fine spray Ultrasound timer counts up in 1 second increments Release footswitch Release footswitch Ultrasound and Flow output stop Ultrasound timer freezes at last reading Function Confirmed Reset ultrasound timer as desired System is now ready for use Function NOT confirmed Console alerts of Mechanical Limit or Electrical Fault or does not respond as expected Refer to troubleshooting section for next steps Table 7 4 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 BoneScalpel System is now ready for use Refer to section 1 0 for general safety statements indications and adverse affects and section 4 0 for use of main system functions BCM UM Rev H Page 33 Instructions For Use BoneScalpel with SonicOne Technology 8 Handpiece Assembly And Disassembly By Application The Misonix Ultrasonic Surgical System can accommodate different tip configurations to perform both soft and hard tissue applications The tip choice is determined by the type of the targeted tissue 8 1 Handpiece Assembly HARD Tissue Use Perform an inspection of h
57. ring ultrasound use must be avoided Such contact can damage the ultrasonic components very easily and may result in compromised performance including failure Discard any extensions or tips 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 4 3 SOFT Tissue Use Recommended Settings For Soft Tissue Use The following settings are general guidelines and should be adjusted based on indication anatomy pathology and surgeon s preference Amplitude Pulse Flow Very Higa 8 mg z210 Higa LB 100 Moderate 5 100 Low 100 100 100 Table 4 2 Recommended settings for soft tissue debridement e Ahigh amplitude setting results in more aggressive tissue removal a low setting in less aggressive tissue removal e A lower amplitude setting in combination with higher irrigation results in less aggressive tissue removal with an increased ability to wash debris from the wound BCM UM Rev H Page 16 Instructions For Use BoneScalpel with SonicOne Technology 5 System Overview 5 1 Principle Of Operation The BoneScalpel system is designed to ultrasonically dissect and fragment hard osseous and soft tissues The system consists of an ultrasonic console with handpiece and accessories The console features an integrated irrigation pump Figure 5 1 BoneScalpel C
58. s 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 9 3 NOTE 9 1 not sealed against liquids and damage to equipment will result Console and Footswitch Wipe Surfaces Wipe footswitch and console including irrigation unit with cloth or absorbent paper moistened with an enzymatic detergent such as ASP Enzol or Steris Prolystica Follow manufacturer s directions for preparing solutions Clean all surfaces of bloodstains and obvious signs of contamination e Dispose of cloth or paper with contaminated waste Table 9 4 Cleaning of console and footswitch Sterilizing By Steam Autoclave Reusable autoclavable Components BCM HP Handpiece BCM BW T Wrench BCM CW Handpiece Counter Wrench BCM SS Probe Cover for hard tissue applications BCM H2 Probe Cover for soft tissue applications BCM CBS Brush Set Small BCM CBL Brush Set Large Table 9 5 Autoclavable components Validated Steam Sterilization Cycles Sterilizer Type Pre Vacuum at 132 C 270 F Gravity at 134 C 273 F Preconditioning pulses 3 Minimum Temperature 132 C 270 F 134 C 273 F Cooling Time Allow items to cool gradually to room temperature prior use Sample configuration Wrapped Wrapped Table 9 6 Steam sterilization cycles Allow reusable autoclavable items
59. se 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 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 patient death 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 BoneScalpel 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 If a Mains Power fuse fails after replacement when the unit is reactivated discontinue use of the device and contact an authorized Misonix representative 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 List Of Cautions CAUTION 1 1 Federal law restr
60. se of above items in accordance with standard hospital procedures for disposal of biocontaminated wastes 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 9 2 Cleaning Follow Standards For Decontamination Cleaning And Sterilization Follow ANSI AAMI ST35 Good Hospital Practice Handling and Biological Contamination of Reusable Medical Devices 1991 or other such guidelines as may be directed by Hospital or Clinic GHP s BCM UM Rev H Page 41 Instructions For Use BoneScalpel with SonicOne Technology BCM UM Rev H Page 42 Instructions For Use BoneScalpel with SonicOne Technology 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 patient death 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 BoneScalpe
61. set Possible Cause Corrective Action 1 Handpiece not Turn mains power OFF connected Check handpiece cable connection Restart console 2 Defective Turn mains power OFF Handpiece Replace handpiece and restart console If problem persists replace console 3 Defective console Turn mains power OFF Replace console Table 6 3 Electrical fault alert and recommended corrective actions BCM UM Rev H Page 28 Instructions For Use BoneScalpel with SonicOne Technology 7 System Set up 7 1 Installation Upon delivery perform a visual inspection of the shipping containers and all system components for obvious shipping damage Retain the shipping container and immediately notify the shipping carrier of any damages found 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 The BoneScalpel system is designed and tested to comply with IEC EN60601 1 2 2007 guidelines for EMC See section 1 for general safety statements WARNING 1 5 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 on the console rear panel is set to th
62. 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 Tip and irrigant temperatures may exceed the tissue necrosis point if insufficient 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 by administering sterile saline with a syringe over the distal tip portion may be necessary for removal of very dense hard osseous structures 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 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 Additional external irrigation e g by
63. ssive tissue removal Amplitude and thus removal rate may alter with size and geometry of the ultrasonic tip Pulse The ultrasonic energy output over time can be reduced by using the pulse mode in which a resting period is inserted within the duty cycle This results in an active period followed by a resting period during each duty cycle The total period is a second 250ms The pulse can be set between 50 and 100 Pulse Setting 100 Continuous The default setting is 100 or continuous which refers to 100 energy output or zero resting period This is the recommended setting for hard tissue applications It can also be used in soft tissue applications Pulse Setting 50 90 Pulsed BCM UM Rev H Page 25 Instructions For Use BoneScalpel with SonicOne Technology The Pulse function minimizes exposure to ultrasound over time In wound debridement procedures this can be beneficial to reduce pain sensation or to decrease the aggressiveness of the debridement The Pulse setting corresponds to the duration of the active period of the ultrasound output For example a Pulse setting of 60 corresponds to an active period of 60 of second 150ms The resulting resting period is 40 of second 100ms The ultrasonic energy output over time is reduced by 40 with this setting Note that the ultrasound timer will only advance during the active period and not during the resting period DI Active Period E Resting Period 0 50
64. t to validate procedures for cleaning and or sterilization if they differ from the procedures as outlined in this manual Technical Assistance Should the user wish further information or instructions regarding any aspect of cleaning or sterilizing procedures please contact Misonix Inc or an Authorized Representative BCM UM Rev H Page 45 Instructions For Use BoneScalpel with SonicOne Technology 10 Troubleshooting The BoneScalpel system provides both visual and audible alert signals when the system is not functioning properly Mechanical Limit Alert Mechanical Limit Displays LIMIT alert located above amplitude setting display Triggers a pulsed audible indicator upon footswitch activation Temporarily deactivates ultrasound and irrigation functions Possible Cause Corrective Action 1 Tip overload Release footswitch Reduce tip pressure and or use higher amplitude setting as required Continue procedure 2 Loose or Release footswitch damaged component Set ultrasound to STANDBY Remove silicone sleeve if applicable and probe cover Inspect extension probe and ultrasonic tip for damage Replace if necessary Otherwise re tighten extension probe and tip using the correct wrenches Set ultrasound to ENABLE Continue procedure 3 Defective Handpiece If corrective action steps above are followed and alert continues the handpiece may need to be replaced Table 6 2 Mechanical limit alert and recommen
65. the tubing connector Handpiece Disassembly post Soft Tissue Use Disconnect Irrigation Tubing Remove Probe Cover Mount os Handpiece Wrench aa Align wrench flats BCM UM Rev H Page 39 Instructions For Use Remove tip Un tighten counter clockwise Table 8 6 Handpiece disassembly post soft tissue use BCM UM Rev H BoneScalpel with SonicOne Technology Page 40 Instructions For Use BoneScalpel with SonicOne Technology 9 Cleaning And Sterilization 9 1 Disassembly Console Tear down Disable Ultrasound Switch to Standby Mode using enable standby button Confirm that Amplitude setting is HOLLOW GREY Switch Console OFF Set Mains Power switch on console rear to OFF Remove Handpiece Pull cable connector from receptacle on console front Cable 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 post hard tissue use and section 8 4 for disassembly post soft tissue use Dispose Of Single Use Items The following items are considered single use items and must not be reused Reuse of these items could result in severe patient injury or death Irrigation tubeset Tips with extensions s Silicon sleeves Once used dispo
66. thin both V notches Close pump cover Close the latch of the irrigation pump until it locks BCM UM Rev H Page 31 Instructions For Use BoneScalpel with SonicOne Technology Connect Tubing to Connect IV Spike to fluid container following standard sterility protocol Irrigation tubing features vented IV spike and is compatible with rigid bottles and flexible bags Fluid Container Prime Tubing Check that ultrasound is in Standby Mode Set Flow rate to 10 Depress footswitch until fluid discharges at ultrasonic tip Adjust Settings Set Amplitude and Flow to desired flow setting Refer to section 5 5 for recommended settings Table 7 3 WARNING 7 1 WARNING 7 2 CAUTION 7 4 CAUTION 7 5 CAUTION 7 6 CAUTION 7 7 WARNING 7 3 WARNING 7 4 BCM UM Rev H Enable ultrasound Console set up part II Improper connection of the handpiece cable may present a shock hazard Confirm that handpiece connector is dry prior to plugging it in 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 Do not place the soft silicone tube behind or in front of the rollers latch removed in illustrations
67. to gradually return to room temperature after steam sterilization and prior to usage BCM UM Rev H Page 44 Instructions For Use BoneScalpel with SonicOne Technology 9 4 Expected Life Reusable Components All handpiece components need to examined regularly prior each use and be replaced if damaged The estimated sterilization life of handpiece components is listed below All sterilization life estimates are approximate and may be affected by rough handling damage wear due to vigorous cleaning etc Estimated Sterilization Life Number Of Steam Sterilization Cycles Handpiece with attached cable gt 200 cycles Wrenches gt 300 cycles Handpiece counter wrench and T wrench Table 9 7 Estimated re use life 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 NOTE 9 1 Allow reusable autoclavable items to gradually return to room temperature after steam sterilization and prior to usage 9 5 Deviations From Decontamination Cleaning And Sterilization Instructions 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 BoneScalpel System and related accessories be followed It is the responsibility of the user of this device or any accessories used with i
68. under extended exposure e g in tight cavities are to be avoided in BoneScalpel hard tissue removal It is recommended to withdraw and re insert the ultrasonic tip repeatedly to re establish adequate cooling and lubrication 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 BCM UM Rev H Page 9 I

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