Home

Bonescalpel User Manual SOP-AIC-5000808

1. A 4 E Wa 4 EUA 5 Re e S SN 0 E A ds 4 a K EA Ei S Apply slight pressure to ensure that tubing rests within both V notches Close pump cover Close the latch of the irrigation pump until it locks Adjust the grip of the V notches Evenly adjust the V notches to their fully opened position by turning the adjustment wheel underneath the front and back of the pump assembly Allow for tight grip to prevent the tubing from slipping but without pinching the tubing which would obstruct the irrigation flow Connect Tubing to Fluid Container Connect IV Spike to fluid container following standard sterility protocol Irrigation tubing features vented V spike and is compatible with rigid bottles and flexible bags Prime Tubing Check that ultrasound is in Standby Mode Set Flow rate to 10 Depress footswitch until fluid discharges at ultrasonic tip Table 7 3 Console set up part SOP AIC 5000808 Rev2 Page 30 of 47 BCA UM RevD Instructions For Use BoneScalpel WARNING 7 1 WARNING 7 2 CAUTION 7 4 CAUTION 7 5 CAUTION 7 6 CAUTION 7 7 WARNING 7 3 WARNING 7 4 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
2. 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 Dispose Of Single Use tems 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 Silicon sleeves Once used dispose 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
3. Relative humidity 10 95 non condensing Ambient pressure extremes 40 000 ft 14 125m Dimensions 7 Hx 16 W 19 180mm H x 410 mm W x 485mm D 25 6 Lb 11 6 kg Table 11 1 Console specifications Instructions For Use BoneScalpel 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 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 120 VAC 60 Hz Cooper Bussman GDB 4 250V 4 A Fast Acting Low Breaking 220 230 240 VAC 50 60 Hz 021702 5 250V 2 54 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
4. 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 Check Function Confirm that console powers up and that Main Settings respond to activation of buttons A F Table 12 2 Fuse replacement SOP AIC 5000808 Rev2 Page 45 of 47 BCA UM RevD Instructions For Use BoneScalpel 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 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 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 s
5. The BoneScalpel Ultrasonic Surgical System can accommodate different tip configurations to perform hard tissue applications 8 1 Handpiece Assembly Perform an inspection of handpiece and all components prior assembly Handpiece I nspection 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
6. Deviations From Decontamination Cleaning And Sterilization Instructions The manufacturer 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 it 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 Aesculap USA or an Authorized Representative SOP AIC 5000808 Rev2 Page 40 of 47 BCA UM RevD Instructions For Use BoneScalpel 10 Troubleshooting The BoneScalpel system provides both visual and audible alert signals when the system is not functioning properly Mechanical Limit Alert Mechanical Limit ML Displays LIMIT alert located above amplitude setting EE display Triggers a pulsed audible alarm 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 sili
7. REMOS y Ste CHECK anaa a a a AS 32 8 Handpiece Assembly And Disassembly By Application 33 8 1 Handpiece Assembly HARD Tissue USC oocococcocococconococnnnococonnnnoconnnnoronnnnoronnnnorennnnnrennnnrrannaness 33 8 2 Handpiece Disassembly HARD Tissue USE ooccocococconococconococnonoconnonoronnnnonoronnonoronnnnoronnnnrrnnnanoss 35 8 3 Handpiece Assembly SOFT Tissue 56 1040 Error Bookmark not defined 8 4 Handpiece Disassembly SOFT Tissue 00 Error Bookmark not defined 9 Cleaning And Sterilization ici e 37 Ol 5500 rori an a a a a a 37 37 9 3 Sterilizing By Steam Autoclave matias datada datada 39 94 Expected lite Reusable 0 39 9 5 Deviations From Decontamination Cleaning And Sterilization 560 40 10 TFOUDIESNOOUING ir diana 41 TL aaa a 44 12 Service Repair And Technical Correspondence csccsecesesseesesenensnsesesenensnsnenseeeeeeenenensnseeeeenensnens 45 1 Fuse REP MENE nnn cere N ee re ee ee eee 45 Celie Ie ap circuses sis A A 46 12 3 Repair Service and Replacement Parts succi n ar tia 46 Ad IMPONE NOU CO didactico id 47 SOP AIC 5000808 Rev2 Page 2 of 47 BCA UM RevD Instructions For Use BoneScalpel 1 General Safety Statements WARNING 1 1 WARNING 1 2 CAUTION 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 m
8. Hospital or Clinic GHP s WARNING 9 2 All reusable handpiece parts and accessories must be properly decontaminated cleaned and sterilized before each use SOP AIC 5000808 Rev2 Page 37 of 47 BCA UM RevD Instructions For Use BoneScalpel as per instructions contained in this manual Failure to do so may lead to infections which can ultimately cause patient death WARNING 9 3 The manufacturer 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 Clean And Disinfect Stenlize Reusable tems The following items are considered reusable items and should be cleaned as recommended Handpiece Counter wrench T wrench Probe cover Probe Cover and Wrenches Wash Brush Wash items with hot water mixed with an enzymatic detergent such as ASP Enzol or Steris 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
9. 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 Minimum Temperature 132 C F 134 C F Cooling Time Allow items to cool gradually to room temperature prior use Sample configuration Wrapped Wrapped Table 9 6 Steam sterilization cycles NOTE 9 1 Allow reusable autoclavable items to gradually return to room temperature after steam sterilization and prior to usage 9 4 Expected Life Reusable Components All handpiece components need to examined regularly prior each use and be replaced if damaged SOP AIC 5000808 Rev2 Page 39 of 47 BCA UM RevD Instructions For Use BoneScalpel 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
10. ensures clearing of debris from the internal passages gt tem 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 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 Table 9 2 Cleaning of probe cover and wrenches Handpiece Wipe Cable e Wipe cable 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 decontamination 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 Rinse e Rinse item under warm running water for a minimum of 1 minute to clear soap residue Dry item fully with absorbent towel or paper Dispose of cloth or paper in accordance with Hospital or Clinic practices for contaminat
11. front panel but do not cover the pump housing or other console portions SOP AIC 5000808 Rev2 Page 9 of 47 Instructions For Use BoneScalpel 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 wrenches Do not over tighten the tubing connector NOTE 9 1 Allow reusable autoclavable items to gradually return to room temperature after steam sterilization and prior to usage 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 1 5 Trademark Information Aesculap is a registered trademark of Aesculap Inc Misonix is a registered trademarks of Misonix Inc Farmingdale NY BoneScalpel is a pending trademark of Misonix Inc Farmingdale NY ASP Enzol and Prolystica are registered tra
12. that the correct fuses are being used Refer to section 12 1 on 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 95 F 13 35 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 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 N A pee EA 6 Ki If Os A LE T 2 ES OSA 1 SS Se N 1 Air vents Figure 7 1 Underside view of console with air vents SOP AIC 5000808 Rev2 Page 28 of 47 BCA UM RevD Instructions For Use BoneScalpel 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 vents may cause unit to overheat and malfunction or create a shock hazard A clear drape can be used t
13. 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 Mount Extension Handpiece Assembly Turn clockwise SOP AIC 5000808 Rev2 Page 33 of 47 BCA UM RevD Instructions For Use BoneScalpel Tighten Extension Mount Ultrasonic Tip Turn clockwise Mount Tip Wrench Ss Align wrench flats Tighten Ultrasonic Tip 4 Match alignment marks Mount Probe Cover Wp Sl E Turn clockwise Monnt Push sleeve over probe cover Sleeve if applicable Connect Irrigation Tubing Turn clockwise Table 8 2 Handpiece assembly The handpiece is now ready for use and can be connected to the BoneScalpel System Please refer to Section 7 0 for details SOP AIC 5000808 Rev2 Page 34 of 47 BCA UM RevD Instructions For Use BoneScalpel Figure 8 1 Fully assembled handpiece If desired mount suitable sterile cable clips or sterile adhesive tape strips to attach irrigation tubing to handpiece cable 8 2 Handpiece Disassembly 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
14. ANDBY 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 ultrasound 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
15. BoneScalpel System Instructions For Use AESCULAP MO AESCULAP Instructions For Use BoneScalpel SOP AIC 5000808 Rev2 Page 1 of 47 BCA UM RevD Instructions For Use BoneScalpel Table of Contents 1 General Safety 3 A 3 1 2 0 aera eae ea ees 6 6 10 50 aa eile iene 7 1 8 10 LO OF oy DOI asiste eae 11 2 Indications And Contra I NGICATIONS 12 Zels o A A ata o o oheaenteniacss tao 12 Lata 7 S 12 3 Adverse p ps e 1 7 a aaa aaa a 13 4 Considerations During Clinical nene ener nena nenas 14 Ale HARD TASSUC USC it Ada 15 2 SOFT FISSE US 0 Error Bookmark not defined Do System Over Wa 17 501 PENE ORO pera 17 5 2 System COMPONEN das 18 5 3 Single use Sterile Components enorer ran a a a a a a ri 19 6 CONSOLO iiia a a a a a a 21 6 1 Receptacles Controls And Indicators cocococconococnonococnonoconnnnoconnnnocornnnonoronnnnoronnnnoronnnrrannnnoss 21 6 2 Men FUNCTIONS A A AAA A AAA AA sea 22 032 Mal 24 26 7 System SOU UD aeien ao a aao a aa a a ao anaoa 28 Tali 0 yan aeelaetee ma icianrtale maces 28 7 2 Console Set up Part Non sterile sist A A A ii 29 kas Handpiece Assembly Sterle hireki a a a a aS EAN 29 7 4 Console Set up Part Il Non sterile ccecccseseseseceseeersrseseeeeeeusetsrseseseaeeusursrseseneaeersinerstsees 30 75
16. Buttons A B ar 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 amplitude is 7 Refer to section 6 3 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 SOP AIC 5000808 Rev2 Page 22 of 47 BCA UM RevD Instructions For Use BoneScalpel 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 AESCULAP 1 Menu Button m mn mm m m A E Custom Buttons A B C D E F Figure 6 4 Options screen Ultrasound timer The elapsed ultrasound time can be r
17. anual 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 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 CAUTION 1 3 CAUTION 1 4 CAUTION 1 5 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 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 The use of accessories transducers and cables other than those specified may result in increased emissions or decreased immunity of the device Use only Aesculap branded equipment and acce
18. cone 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 recommended 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 SOP AIC 5000808 Rev2 Page 41 of 47 BCA UM RevD Instructions For Use BoneScalpel Electrical Fault Alert Electrical Fault Displays Electrical Fault Screen Triggers steady audible alarm 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
19. d 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 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
20. d or kept brief with minimal amount of contact pressure Pressure and extended exposure can still result in excessive frictional SOP AIC 5000808 Rev2 Page 7 of 47 BCA UM RevD Instructions For Use WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING 10 1 WARNING 12 1 4 2 4 3 4 4 6 1 41 7 2 7 3 1 4 8 1 9 1 9 2 9 3 BoneScalpel heat and cause burns 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 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 ultraso
21. d relative to tissue A continuous tip 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 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 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 SOP AIC 5000808 Rev2 Page 15 of 47 BCA UM RevD Instructions For Use BoneScalpel 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 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
22. demarks of STERIS Corporation Mentor OH SOP AIC 5000808 Rev2 Page 10 of 47 BCA UM RevD Instructions For Use BoneScalpel 1 6 Explanation Of Symbols Console Related Symbols Enable Standby Caution Maine Poweron Ultrasound Dangerous voltage Scroll through Caution Consult accompanying Mains Power OFF menu pages documents Caution Protective Amplitude setting Pinch hazard earth ground Consult Equipotentiality Pulse setting Instructions for Use connection Disposal to be compliant with EN 50419 WEEE directive Type B equipment Restricted to sale by or on the order of a physician only Sterilized using Ethylene Oxide Do not use if packaging is damaged Sterilized using Authorized Gamma Irradiation representative Contents are latex free Use by date indicated Catalog number Do not expose to temperatures greater than indicated Lot or batch code AC Voltage Must use hospital grade power cord Fuse Manufacturer only Classified by UL Contains DEHP d E gt Footswitch and or Phthalates connector Table 1 7 Explanation of symbols SOP AIC 5000808 Rev2 Page 11 of 47 BCA UM RevD Instructions For Use BoneScalpel 2 Indications And Contra I ndications 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 Or
23. e 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 and 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 SOP AIC 5000808 Rev2 Page 23 of 47 BCA UM RevD Instructions For Use BoneScalpel Help Screen The Help Screen provides access to a quick guide on system operation and troubleshooting AESCULAP HELP MENU O A SYSTEM OPERATION B TROUBLESHOOTING PRESS MENU FOR MAIN SCREEN DIA nd bdid E 1 Menu Button A E Custom Buttons A B CD EP 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 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 chang
24. e wrapping List Of Notes NOTE 4 1 After extended periods of operation the bottom of the console housing may become warm to the touch This is normal Do not touch the bottom of the console housing while in operation or shortly after operation NOTE 4 2 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 NOTE 4 3 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 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 vents may cause unit to overheat and malfunction or create a shock hazard A clear drape can be used to protect the console
25. eaned 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 SOP AIC 5000808 Rev2 Page 29 of 47 BCA UM RevD Instructions For Use BoneScalpel 7 4 Console Set up Part Non sterile Console Set up Part II Connect Handpiece cable Attach cable connector receptacle on console front panel 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 The arrow on the pump housing indicates the direction of flow 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 V notches Place and hold the tubing s silicone section in the V notches on both pump sides ah A i e y AOA eae 0 x 9 lt Es Y a ak 2 N eat es P YF A f fF 0 S EN 86 MIERE 4 Me ve ae m SR a gt wie a ae am 4 oa ut ge FF TA
26. ectro 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 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 Aesculap USA representative WARNING 1 4 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 WARNING 1 5 Connecting the con
27. ed 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 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 SOP AIC 5000808 Rev2 Page 38 of 47 BCA UM RevD Instructions For Use BoneScalpel CAUTION 9 2 Be certain to clear debris from all internal passages by brushing Failure to do so may hinder sterilization of units during autoclaving CAUTION 9 3 Do not immerse ultrasonic console handpiece irrigation pump remote footswitch or electric cables These items are not sealed against liquids 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 decontamination e Dispose of cloth or paper with contaminated waste Table 9 4 Cleaning of console and footswitch 9 3 Sterilizing By Steam Autoclave Reusable autoclavable Components Handpiece T Wrench Handpiece Counter Wrench Probe Cover for hard tissue applications Brush Set Small Brush Set
28. haft 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 Aesculap USA or an authorized Aesculap USA 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 SOP AIC 5000808 Rev2 Page 46 of 47 BCA UM RevD Instructions For Use BoneScalpel CAUTION 12 1 Use only genuine replacement parts from Aesculap 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 wrapping 12 4 Important Notice Please contact Aesculap USA with any questions regarding the specifications use sterilization limitations or maintenance of the BoneScalpel System Aesculap Inc Web www aesculapusa com Email info aesculap com Phone 1 800 258 1946 Customer Service 1 800 282 9000 Technical Service 1 800 214 3392 Address 3773 Corporate Parkway Center Valley PA 18034 U S A By returning any material to Aesculap USA the customer or the customer s agent must certify
29. 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 alarm 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 WARNING 1 4 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 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 Aesculap USA representative SOP AIC 5000808 Rev2 Page 42 of 47 BCA UM RevD Instructions For Use BoneScalpel Lack of I rrigant Symptons e Nospray from tip when ultrasound is engaged e No flush fluid available Unexpected temperature rise at operative site e Unexpected temperature rise of handpiece Possible Cause Ultrasound Mode Corrective Action 1 Closed or Set ultrasound to ST
30. 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 A peristaltic pump integrated into the BoneScalpel console provides irrigant to the operative site during use SOP AIC 5000808 Rev2 Page 17 of 47 BCA UM RevD Instructions For Use BoneScalpel 5 2 Reusable System Components The following system components represent the minimum requirements for performing hard tissue procedures They can be ordered as a system or individually Required System Components MC634 BoneScalpel console AESCULAP nes l MC632 MC637 Counter wrench Compatible with MC632 MC628 T Wrench Compatible with e MC922 MC923 MC925 MC926 MC927 1 ea 1 ea 1 ea 1 ea ea Probe cover Compatible with 1 MC922 MC923 NC i MC925 M MC926 4 A MC927 Table 5 1 Required system components Components and quantities included with the system may change over time please check with your Aesculap USA representative for the most current configuration SOP AIC 5000808 Rev2 Page 18 of 47 BCA UM RevD Instructions For Use BoneScalpel 5 3 Single use Sterile Components At least one irrigation tubeset must be available for each surgical procedure Irrigation Tubeset MC924 Irrigation Tubeset Table 5 2 Irrigation tubeset Ultrasonic tips are supplied sterile and are for single use only A
31. ing 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 aggressive 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 Ya 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 Pulse Setting 50 90 Pulsed The Pulse function minimizes exposure to ultrasound over time SOP AIC 5000808 Rev2 Page 24 of 47 BCA UM RevD Instructions For Use BoneScalpel 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 For most applications the recomme
32. 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 Electromagnetic environment Immunity test Compliance level test level guidance Electrostatic discharge ESD 66 722 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 66 1 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 NOTE Table 1 2 Handpiece cable Power cord Footswitch cable Table 1 3 SOP AIC 5000808 Rev2 BCA UM RevD 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 Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 U 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur 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 Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec Ur is the AC mains voltage prior to application of the test level List of Cables Floors should be w
33. irm 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 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 SOP AIC 5000808 Rev2 Page 6 of 47 BCA UM RevD Instructions For Use BoneScalpel 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 Aesculap USA 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 6 Conventions on warnings cautions and notes List Of Warnings WARNING 1 1 The BoneScalpel system is an el
34. 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 AS ANA yaa Ns S A Q 6 A fi YX N S 6 h X lt Do not pinch the soft silicone tube when the latch is locked Do not pinch barb fittings when closing the latch Ci 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 increase The BoneScalpel System is n
35. 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 malfunctions please contact Aesculap USA or an Aesculap USA authorized representative for service SOP AIC 5000808 Rev2 Page 43 of 47 BCA UM RevD 11 Specifications Console Specifications Power input 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 uA max Output power 130 Watts max Mode of Operation e Continuous Wave e Pulse Wave Controls e Mains Power on off switch rear panel 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 Handpiece cable e 15 ft 4 6m Footswitch cable e 14ft 4 3m Power cord e 10ft 3 0m Operating conditions e Temperature 55 95 F 13 35 C Relative humidity 20 90 non condensing Standard atmospheric pressure Shipping storage conditions Temperature 35 120 F 2 49 C
36. 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 CAUTION 8 1 Ensure all connections and mating surfaces of handpiece extension and ultrasonic tip are clean and dry before assembly 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 passages by brushing Failure to do so may hinder sterilization of units during autoclaving CAUTION 9 3 Do not immerse ultrasonic console handpiece irrigation pump remote footswitch or electric cables These items are not sealed against liquids and damage to equipment will result CAUTION 12 1 Use only genuine replacement parts from Aesculap 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 protectiv
37. m the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms IEC 61000 4 6 150 kHz to 80 MHz TEDAN 80 MHz to 800 MHz Radiated RF 3 V m 3 800 MHz to 2 5 GHz IEC 61000 4 3 80 MHz to 2 5 GHz l l where P is 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 I nterference may occur in the vicinity of equipment marked with the following symbol Co 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 strengths 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 obser
38. may become warm to the touch This is normal Do not touch the bottom of the console housing while in operation or shortly after operation 4 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 Low Pulse Flow ee 0 100 100 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 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 WARNING 3 2 WARNING 4 2 CAUTION 4 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 Tissue necrosis may result if tip is not move
39. moval of very dense hard osseous structures WARNING 3 2 Tissue necrosis may result if tip is not moved relative to tissue A continuous tip 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 SOP AIC 5000808 Rev2 Page 13 of 47 BCA UM RevD Instructions For Use BoneScalpel 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 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 A 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 SOP AIC 5000808 Rev2 Page 14 of 47 BCA UM RevD Instructions For Use BoneScalpel NOTE 4 1 brief with minimal amount of contact pressure Pressure and extended exposure can still result in excessive frictional heat and cause burns After extended periods of operation the bottom of the console housing
40. ndby function 6 4 Alerts And Alarms 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 alarm 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 pun display Triggers a pulsed audible alarm 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 recommended corrective actions SOP AIC 5000808 Rev2 Page 26 of 47 BCA UM RevD Instructions For Use BoneScalpel Tip overload can occur during hard
41. nded pulse setting is 100 Active Period Resting Period 0 20 BO 0 a0 g0 100 Duty Cycle O 25 50 YO 100 125 150 179 200 225 250 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 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 SOP AIC 5000808 Rev2 Page 25 of 47 BCA UM RevD Instructions For Use BoneScalpel 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 sta
42. nents 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 SOP AIC 5000808 Rev2 Page 16 of 47 BCA UM RevD Instructions For Use BoneScalpel 5 System Overview 5 1 Principle Of Operation The BoneScalpel system is designed to ultrasonically dissect and fragment hard osseous tissues The system consists of an ultrasonic console with handpiece and accessories The console features an integrated irrigation pump AESCULAP 9 Figure 5 1 BoneScalpel Console 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 0 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
43. o protect the console front panel but do not cover the pump housing or other console portions 7 2 Console Set up Part Non sterile Switch Mains Power OFF Set Mains Power switch on console rear to OFF Connect I V pole Connect IV pole to receptacle in console rear Hang container with sterile irrigant into IV pole hook Irrigation tubing features IV spike and is compatible with rigid bottles or flexible bags Connect Electrical Power Connect power cord to receptacle on console rear and to wall outlet Connect Footswitch 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 Switch Mains Power ON 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 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 tissue applications Once the handpiece has been assembled continue with part II of the Console Set Up CAUTION 7 2 All items intended for use in the sterile field must be cl
44. 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 WARNING 4 4 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 CAUTION 4 2 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 NOTE 4 2 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 NOTE 4 3 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 compo
45. on 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 SOP AIC 5000808 Rev2 Page 27 of 47 BCA UM RevD Instructions For Use BoneScalpel 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 2001 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 the local voltage setting and ensure
46. ood 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 of 47 Instructions For Use BoneScalpel Guidance And Manufacturer s Declaration Electromagnetic mmunity Table 204 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 I mmunity test MES p de i Electromagnetic environment guidance 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 fro
47. ow ready for the system check SOP AIC 5000808 Rev2 Page 31 of 47 BCA UM RevD Instructions For Use BoneScalpel 7 5 Perform System Check System Check Enable Ultrasound Switch to Enable Mode using enable standby button Confirm that Amplitude setting is FILLED GREEN Depress 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 SOP AIC 5000808 Rev2 Page 32 of 47 BCA UM RevD Instructions For Use BoneScalpel 8 Handpiece Assembly And Disassembly
48. rrigant flow rate with respective controls on the panel below Additional controls for ultrasound enable standby and menu access are provided on the left of the display panel An ultrasound timer indicates the elapsed time in which the ultrasound was on 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 MISONI sc x Y BoneScalpel gt OO 41 UE UNA AB CD EF 8 9 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 SOP AIC 5000808 Rev2 Page 21 of 47 BCA UM RevD Instructions For Use BoneScalpel 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 AESCULAP 1 Menu Button bl 01 SS OI PUSO ESO O A E Custom
49. sole 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 fuse replacement 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 may result if tip is not moved relative to tissue A continuous tip 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 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 A 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 avoide
50. ssories 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 RF emissions The BONESCALPEL SYSTEM uses RF energy only for its internal CISPR 11 function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class A CISPR 11 0 The BONESCALPEL SYSTEM is suitable for use in all establishments H i i E E 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 BCA UM RevD domestic purposes flicker emissions Complies IEC 61000 3 3 Table 1 1 Guidance amp manufacturer s declaration on electromagnetic emissions EN table 201 SOP AIC 5000808 Rev2 Page 3 of 47 Instructions For Use BoneScalpel Guidance And Manufacturer s Declaration Electromagnetic mmunity rape 202 The BONESCALPEL SYSTEM is
51. t least one of the following tips must be available for each surgical procedure Includes blade short extension and silicone sleeve Bone Scalpel 20mm Blunt O 0 eS Includes blade short extension and silicone sleeve BoneScalpel 20mm serrated blade and silicone sleeve Bone Shaver Micro Hook Includes blade long curved extension and silicone sleeve SOP AIC 5000808 Rev2 Page 19 of 47 BCA UM RevD Instructions For Use BoneScalpel Bone Scalpel 20mm Blunt Long Curved Requires BCM SS mn probe cover SS PER Includes blade long curved extension and silicone sleeve Table 5 3 Tips SOP AIC 5000808 Rev2 Page 20 of 47 BCA UM RevD Instructions For Use BoneScalpel 6 Console 6 1 Receptacles Controls And Indicators The rear of the console features receptacles for the power cord fuses footswitch cable and V pole as well as a switch for mains power 1 IV pole receptacle Mains power on off Power cord receptacle with fuse block Voltage selector switch Cooling fan Equipotentiality connection Footswitch receptacle LJ N SH UN Bf 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 i
52. that any and all matenals so retumed 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 matenal for which such certification cannot be made without prior approval from Aesculap USA The correct return address should read as follows Aesculap Inc 615 Lambert Pointe RMA lt O Hazelwood MO 63042 Phone 1 800 258 1946 U S A Distributed in the U S A by Aesculap Inc 3773 Corporate Parkway Center Valley PA 18034 Phone 1 800 258 1946 Manufactured by Misonix Inc 1938 New Highway Farmingdale NY 11735 Phone 1 800 694 9612 SOP AIC 5000808 Rev2 Effective 07 12 12 Page 47 of 47 BCA UM RevD AESCULAP Customer Service 1 800 282 9000 Technical Service 1 800 214 3392 3773 Corporate Parkway Center Valley PA 18034 U S A
53. thopedic Surgery Plastic and Reconstructive Surgery Thoracic Surgery NeuroSurgery General Surgery 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 SOP AIC 5000808 Rev2 Page 12 of 47 BCA UM RevD Instructions For Use BoneScalpel 3 Adverse Effects CAUTION 3 1 The BoneScalpel system and its accessories may emit harmful acoustic pressure if exposure exceeds recommended limits Limits For Airborn Acoustic Exposure Minimum Operating Distance Maximum Exposure Period From operator s or patient s ear Within a 24hour period Not to exceed 30 minutes 12 24 30 cm 60 cm Not to exceed 90 minutes Not to exceed 240 minutes 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 6 0 by administering sterile saline with a syringe over the distal tip portion may be necessary for re
54. 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 wrenches Do not over tighten the tubing connector Handpiece Disassembly Disconnect Irrigation Tubing Turn counter clockwise ioe Ps Remove me Ge Sheath 0 7 oye gt EE n Ez a Na MA a Sy Pull sheath from probe cover SOP AIC 5000808 Rev2 Page 35 of 47 BCA UM RevD Instructions For Use BoneScalpel Remove Probe Cover L Turn counter clockwise Mount Handpiece Wrench Mount Tip Wrench Remove Ultrasonic Tip Table 8 3 Handpiece disassembly SOP AIC 5000808 Rev2 Page 36 of 47 BCA UM RevD Instructions For Use BoneScalpel 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
55. 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 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 alarm 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 alarm 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 Electrical Fault Displays Electrical Fault Screen Triggers steady audible alarm Permanently deactivates ultrasound and irrigation Requires recycling of mains power switch to re set Possible Cause Corrective Acti
56. 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 Aesculap USA representative WARNING 1 4 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 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 Conf
57. und 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 alarm 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 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 Heat is being generated at the tip tissue interface A continuous lateral s
58. utlet 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 CAUTION 1 2 CAUTION 1 3 CAUTION 1 4 SOP AIC 5000808 Rev2 BCA UM RevD Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner 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 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 The use of accessories transducers and cables other than those specified may result in increased emissions or Page 8 of 47 Instructions For Use BoneScalpel BCA UM RevD decreased immunity of the device Use only Aesculap 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 use
59. ved 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 SOP AIC 5000808 Rev2 Page 5 of 47 BCA UM RevD Instructions For Use BoneScalpel Recommended Separation Distances Between Portable And Mobile RF Communications Equipment And The BONESCALPEL SYSTEM tapie 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 maximum output power of the communications equipment Rated maximum output Separation distance bi to frequency of transmitter power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz batay Leidy sO Bur 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 P is the maximum output power rating of the transmitter in watts W according to the
60. weeping 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 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 stenlize 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 The manufacturer 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 Aesculap USA representative Connecting the console to a power o

Bonescalpel User Manual SOP-AIC-5000808

Contents

Download Pdf Manuals

Related Search

Related Contents