Instructions for Use
50 Pages
Preview
Page 1
BoneScalpel™ System Instructions For Use
Instructions For Use
SOP-AIC-5000808 Rev2 BCA-UM RevD
BoneScalpel™
Page 1 of 47
Instructions For Use
BoneScalpel™
Table of Contents 1. General Safety Statements...3 1.1. EMC Statement ... 3 1.2. Electrical Safety Statement ... 6 1.3. Environmental Statement ... 6 1.4. Summary Of Safety Notices ... 7 1.5. Trademark Information ... 10 1.6. Explanation Of Symbols... 11 2. Indications And Contra Indications ...12 2.1. Indications... 12 2.2. Contra Indications ... 12 3. Adverse Effects...13 4. Considerations During Clinical Use ...14 4.1. HARD Tissue Use... 15 4.2. SOFT Tissue Use ...Error! Bookmark not defined. 5. System Overview...17 5.1. Principle Of Operation ... 17 5.2. Reusable System Components ... 18 5.3. Single-use, Sterile Components ... 19 6. Console ...21 6.1. Receptacles, Controls And Indicators ... 21 6.2. Menu Functions ... 22 6.3. Main Functions ... 24 6.4. Alerts And Alarms ... 26 7. System Set-up ...28 7.1. Installation ... 28 7.2. Console Set-up – Part I (Non-sterile) ... 29 7.3. Handpiece Assembly (Sterile)... 29 7.4. Console Set-up – Part II (Non-sterile) ... 30 7.5. Perform System Check ... 32 8. Handpiece Assembly And Disassembly By Application ...33 8.1. Handpiece Assembly - HARD Tissue Use ... 33 8.2. Handpiece Disassembly - HARD Tissue Use ... 35 8.3. Handpiece Assembly - SOFT Tissue Use ...Error! Bookmark not defined. 8.4. Handpiece Disassembly - SOFT Tissue Use ...Error! Bookmark not defined. 9. Cleaning And Sterilization ...37 9.1. Disassembly... 37 9.2. Cleaning... 37 9.3. Sterilizing By Steam Autoclave ... 39 9.4. Expected Life, Reusable Components... 39 9.5. Deviations From Decontamination, Cleaning And Sterilization Instructions... 40 10. Troubleshooting ...41 11. Specifications ...44 12. Service, Repair And Technical Correspondence ...45 12.1. Fuse Replacement ... 45 12.2. Pump Head Replacement ... 46 12.3. Repair, Service and Replacement Parts ... 46 12.4. Important Notice ... 47
SOP-AIC-5000808 Rev2 BCA-UM RevD
Page 2 of 47
Instructions For Use
BoneScalpel™
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 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 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 used.
Electromagnetic Compatibility Guidance (in accordance with EN/IEC 60601-1-2:2007) Guidance And Manufacturer’s Declaration – Electromagnetic Emissions (Table 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. Emissions test RF emissions CISPR 11 RF emissions
Compliance
Electromagnetic environment – guidance
Group 1
The BONESCALPEL SYSTEM uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
Class A
CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions
Class A
The BONESCALPEL SYSTEM is suitable for use in all establishments other than domestic and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes.
Complies
IEC 61000-3-3
Table 1.1 SOP-AIC-5000808 Rev2 BCA-UM RevD
Guidance & manufacturer’s declaration on electromagnetic emissions (EN table 201) Page 3 of 47
Instructions For Use
BoneScalpel™
Guidance And Manufacturer’s Declaration – Electromagnetic Immunity (Table 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 test level
Immunity test
Compliance level
Electromagnetic environment – guidance
o ±6 kV contact
o ±6 kV contact
o ±8 kV air
o 8 kV air
Electrical fast transient/burst
o ±2 kV for power supply lines
IEC 61000-4-4
o ±1 kV for
o ±2 kV for power supply lines o ±1 kV for input/output lines
Mains power quality should be that of a typical commercial or hospital environment.
Surge
o ±1 kV differential mode
o ±2 kV common mode
o ±1 kV differential mode o 2 kV common mode
Mains power quality should be that of a typical commercial or hospital environment.
<5 % UT (>95 % dip in UT) for 0,5 cycle
<5 % UT (>95 % dip in UT) for 0,5 cycle
40 % UT (60 % dip in UT) for 5 cycles
40 % UT (60 % dip in UT) for 5 cycles
70 % UT (30 % dip in UT) for 25 cycles
70 % UT (30 % dip in UT) for 25 cycles
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.
<5 % UT (>95 % dip in UT) for 5 sec
<5 % UT (>95 % dip in UT) for 5 sec
3 A/m
3 A/m
Electrostatic discharge (ESD) IEC 61000-4-2
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
input/output lines
IEC 61000-4-8 NOTE
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
UT is the AC mains voltage prior to application of the test level.
Table 1.2
Guidance & manufacturer’s declaration on electromagnetic immunity (EN table 202)
List of Cables Item
Cable Length
Type
Handpiece cable
15 ft | 4.6 m
shielded 2-conductor
Power cord
10 ft | 3.0 m
unshielded 3-conducter
Footswitch cable
14 ft | 4.3 m
shielded 2-conductor
Table 1.3
SOP-AIC-5000808 Rev2 BCA-UM RevD
List of cables
Page 4 of 47
Instructions For Use
BoneScalpel™
Guidance And Manufacturer’s Declaration – Electromagnetic Immunity (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. Immunity test
IEC 60601 test level
Compliance level
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 from 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
Radiated RF
3 V/m
IEC 61000-4-3
80 MHz to 2.5 GHz
3V
3 V/m
d
1.2 P
d
1.2 P
80 MHz to 800 MHz
d
2.3 P
800 MHz to 2.5 GHz
where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b
Interference may occur in the vicinity of equipment marked with the following symbol:
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.
a
b
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 observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting 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
SOP-AIC-5000808 Rev2 BCA-UM RevD
Guidance & manufacturer’s declaration on electromagnetic immunity (EN table 204)
Page 5 of 47
Instructions For Use
BoneScalpel™
Recommended Separation Distances Between Portable And Mobile RF Communications Equipment And The BONESCALPEL SYSTEM (Table 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 power of transmitter W
Separation distance according to frequency of transmitter M 150 kHz to 80 MHz
d
1.2 P
80 MHz to 800 MHz
d
1.2 P
800 MHz to 2,5 GHz
d
2. 3 P
0.01
0.12
0.12
0.23
0.1
0.37
0.37
0.37
1
1.2
1.2
2.3
10
3.7
3.7
7.4
100
12
12
23
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 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
1.2.
Recommended separation distances (EN table 206)
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. 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.
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 BCA-UM RevD
Page 6 of 47
Instructions For Use
1.4.
BoneScalpel™
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 WARNING
Denotes potentially dangerous situation that could result in death or serious injury to patient, operator or staff.
CAUTION
Denotes potentially dangerous situation that could result in moderate injury to patient, operator or staff.
NOTE
Indicates potential hazard that may result in product damage.
Table 1.6
Conventions on warnings, cautions and notes
List Of Warnings 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.
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. 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 avoided or kept brief with minimal amount of contact pressure. Pressure and extended exposure can still result in excessive frictional
SOP-AIC-5000808 Rev2 BCA-UM RevD
Page 7 of 47
Instructions For Use
BoneScalpel™
heat and cause burns. 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.
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 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.
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 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.
WARNING 7.3
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.
WARNING 7.4
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.
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.
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
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.
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.
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
List Of Cautions CAUTION 1.1
Federal law restricts 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
SOP-AIC-5000808 Rev2 BCA-UM RevD
Page 8 of 47
Instructions For Use
BoneScalpel™
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 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) 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 reestablish 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.
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 protective 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 front panel but do not cover the pump housing or other console portions.
SOP-AIC-5000808 Rev2 BCA-UM RevD
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 trademarks of STERIS Corporation, Mentor, OH
SOP-AIC-5000808 Rev2 BCA-UM RevD
Page 10 of 47
Instructions For Use
1.6.
BoneScalpel™
Explanation Of Symbols Console Related Symbols
Symbol
Description
Symbol
°C Max
Table 1.7
Description
Caution: Dangerous voltage
Mains Power ON
Scroll through
Caution: Consult accompanying documents
Mains Power OFF
Amplitude setting
Caution: Pinch hazard
Protective earth ground
Pulse setting
Consult Instructions for Use
Equipotentiality connection
Type B equipment
Disposal to be compliant with EN 50419 (WEEE directive)
Flow setting
LATEX
Symbol
Enable / Standby Ultrasound
menu pages
2
Description
Do not reuse
STERILE EO
Sterilized using Ethylene Oxide
Rx ONLY
Restricted to sale by or on the order of a physician only
Do not use if packaging is damaged
STERILE R
Sterilized using Gamma Irradiation
EC REP
Authorized representative
Use by date indicated
REF
Catalog number
Lot or batch code
~
AC Voltage
Contents are latex-free
Do not expose to temperatures greater than indicated
LOT
Must use hospital grade power cord only
Fuse
Manufacturer
Contains DEHP and/or Phthalates
Classified by UL
Footswitch connector
Explanation of symbols
SOP-AIC-5000808 Rev2 BCA-UM RevD
Page 11 of 47
Instructions For Use
BoneScalpel™
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 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 BCA-UM RevD
Page 12 of 47
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 3” - 12” 8 cm – 30 cm Not to exceed 30 minutes 12” - 24” 30 cm – 60 cm Not to exceed 90 minutes > 24” 60 cm 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, 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.
SOP-AIC-5000808 Rev2 BCA-UM RevD
Page 13 of 47
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
WARNING 4.1
Incorrect hand position
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 BCA-UM RevD
Page 14 of 47
Instructions For Use
BoneScalpel™
brief with minimal amount of contact pressure. Pressure and extended exposure can still result in excessive frictional heat and cause burns. NOTE 4.1
4.2.
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.
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. Highest Very High High Standard (Default) Moderate Low Table 4.1
Amplitude 10 9 8 7 6 5
Pulse 100% 100% 100% 100% 100% 100%
Flow 100% 90% 80% 70% 60% 50%
Recommended settings for hard tissue removal
A high 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. 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 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 4.2
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.
SOP-AIC-5000808 Rev2 BCA-UM RevD
Page 15 of 47
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 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 reestablish 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 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.
SOP-AIC-5000808 Rev2 BCA-UM RevD
Page 16 of 47
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.
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. o
o 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. Bone shaving tips are used for sculpting bone. They have an abrasive surface for bone removal through abrasion under ultrasonic oscillation. 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 BCA-UM RevD
Page 17 of 47
Instructions For Use
5.2.
BoneScalpel™
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
1 ea.
Includes IV pole, power cord, footswitch, peristaltic pump and instructions for use MC632
BoneScalpel handpiece
MC637
Counter wrench
1 ea.
Compatible with
1 ea.
MC632
MC628
T-Wrench
Compatible with
1 ea.
MC922 MC923 MC925 MC926 MC927
MC631
Probe cover
Compatible with
1 ea.
MC922 MC923 MC925 MC926 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 BCA-UM RevD
Page 18 of 47
Instructions For Use
5.3.
BoneScalpel™
Single-use, Sterile Components
At least one irrigation tubeset must be available for each surgical procedure. Irrigation Tubeset MC924
Table 5.2
Irrigation Tubeset
1 ea.
Irrigation tubeset
Ultrasonic 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 All tips requires MC631 probe cover MC922
Bone Scalpel – 10mm, Blunt
1 ea.
Includes blade, short extension, and silicone sleeve MC923
Bone Scalpel – 20mm, Blunt
1 ea.
Includes blade, short extension, and silicone sleeve MC928
BoneScalpel –20mm, serrated blade
and silicone sleeve MC925
Bone Shaver – Micro Hook
1 ea.
Includes blade, short extension, 1 ea.
Includes shaver tip, short extension and silicone sleeve MC927
Bone Scalpel – 10mm, Blunt, Long Straight
1 ea.
Includes blade, long curved extension, and silicone sleeve MC926
Bone Scalpel – 10mm, Blunt, Long Curved
1 ea.
Includes blade, long curved extension, and silicone sleeve SOP-AIC-5000808 Rev2 BCA-UM RevD
Page 19 of 47