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EN
PHYSICIAN NOTE: The physician must convey the indications, contraindications, warnings, and precautions given in this document to the patient. Refer to the Midas Rex™ Legend™ Pneumatic High Speed or EHS Instruction Manual for full Legend™ motor instructions.
Device description The Legend™ Pneumatic Bone Mill is composed of the BM100 base (multi-use and provided non-sterile) and BM200 disposable (single-use and provided sterile). The BM200 has 3 components: bowl, cap (with LOW and HIGH sides), and spatula. A Legend™ motor provides power to drive the Pneumatic Bone Mill, which is intended to mill bone into particles 1 to 5 mm in size.
Indications for use The Midas Rex™ Pneumatic Bone Mill is intended to mill bone, producing bone particles 1 to 5 mm in size for neurosurgery and orthopedic surgery where bone grafting is desired by the doctor or surgeon.
Target patient population Patients scheduled for surgical applications stated in the indications for use.
Intended use This device is intended to be used in the operating suite of a hospital or surgical clinic to enable medical professionals familiar in using the Midas Rex™ Bone Mill system in the surgical applications as in the indications for use.
Contraindications None.
Warnings • • • • •
Do not come in contact with the interior of the disposable bowl and cap during bone milling. Do not use BM100 unless cleaned and sterilized per sterilization cycles provided in this manual. An improperly cleaned or sterilized device may result in patient infection. Do not use BM200 if either the inner or outer tray is damaged. Device sterility may be compromised and cause infection. Do not use BM200 for more than one patient. This may cause cross-contamination and/or infection. The use of components or devices of other manufacturers in conjunction with the Legend™ Pneumatic Bone Mill has not been verified and may alter its performance characteristics.
Precautions • • • • • •
Do not use the EM200 motor with the bone mill. It may overheat and cause a thermal injury. Do not use EM100A motors with an EC100 console. It may cause damage to the equipment. Always unlock the motor before reaching into the bowl to prevent accidental activation of the motor and possible user injury. Only use Midas Rex™ Legend™ motors and BM200 with the BM100 or equipment may be damaged. Do not use the bone mill in the presence of Magnetic Resonance Imaging devices. It may cause damage to the equipment. Do not activate the motor with the cap removed. It may cause bone to eject and strike the user. Always wear eye protection while using the Pneumatic Bone Mill.
Training requirements This device is intended for use by physicians trained in the procedures described in the indications for use.
Residual risks Residual risk related to the use of the disposable bowl is potential infection if (1) the packaging is compromised prior to use, (2) the reusable base is not sterilized prior to use, or (3) the disposable components are reused in multiple procedures.
Possible adverse events In the event that a serious incident has occurred related to device use, immediately report the event to Medtronic and the competent authorities.
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Material Composition Material contained in product that can cause an allergic reaction: nickel. Additional materials of concern information such as REACH, CA Prop 65, or other product stewardship programs, go to www.medtronic.com/productstewardship.
Setup and use 1.
Install bowl • •
2.
Add bone • • •
3.
4.
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Align tabs with slots and lower cap. Use HIGH side for large pieces or large batches of bone. The LOW side is used to more rapidly mill smaller pieces or amounts of bone or when HIGH side becomes less efficient.
Secure cap • •
LOW
aution: The addition of any liquid to the milling process should be C administered in small volume to prevent leakage. Place pieces of bone into bowl. Ensure pieces are no larger than 1.5 cc and there are no more than 6 pieces in a batch.
Insert cap • • •
HIGH
aution: Do not use the bone mill without bowl latches secured. It may cause C damage to equipment. Insert bowl into base and secure with latches.
Rotate cap counter-clockwise. Caution: Activation of bone mill without cap secured may result in loss of bone.
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5.
Insert motor • •
6.
Mill Bone • •
• • • • • 7.
Start motor to begin milling. Note: Milling time is dependent on the density of the patient’s bone, the ratio of cancellous and cortical bone, the starting size of bone pieces and batch volume. Always check bone size after no more than 15 seconds of milling to evaluate progress toward the desired size. If cap is on LOW side and bone jams or does not mill, unlock motor and install cap on HIGH side. If cap is on HIGH side and bone jams or does not mill, reduce the amount of bone inside the bowl. If the blade gets stuck on bone and will not rotate, unlock motor, remove cap, and use spatula to free bone from blade. Mill for 5-15 seconds and inspect bone size before continuing. Continue milling in 5-15 second intervals until bone has reached desired size.
Remove bone • •
8.
Align, insert, and rotate to lock motor with base. Run pneumatic motors at pressures between 120 psi/8.3 bar and 80 psi/8.3 bar.
aution: Do not activate motor with cap removed. It may cause bone to eject C and strike user. Always wear eye protection while using the Pneumatic Bone Mill. Unlock motor. Remove cap by rotating clockwise and lifting. Use spatula to remove bone from inside bowl and cap.
Mill more bone •
After removing bone, additional bone may be milled as needed, up to a total of 40 cc total volume for a single BM200 disposable.
Disassembly and disposal 1.
Unlock motor and remove.
2.
Clean motor according to its IFU, available at manuals.medtronic.com.
3.
Unlatch the BM200 disposable from the base.
4.
Dispose of the BM200 bowl, cap, and spatula according to hospital, administrative, or local government policies or procedures.
5.
Clean the BM100 base according to this IFU.
Sterility The Midas Rex™ Legend™ Pneumatic Bone Mill Attachment is reusable and must be cleaned and sterilized prior to each use. The disposable components are provided sterile and intended for single patient use only. These components are sterilized in a highly controlled environment by radiation. Do not use if package is damaged.
Cleaning and sterilization instructions Warnings and precautions
The bone mill bowl, cap, and spatula are sterile, single-use devices. Opened, but unused, bone mill disposables may not be resterilized under any sterilization method. Do not immerse or soak the bone mill base. Do not use chlorine-based or corrosive cleaning agents such as bleach, acetone, solutions containing glutaraldehyde, etc.
Cleaning: Manual cleaning of the base
• Wipe all surfaces of the bone mill base with a cloth dampened with a neutral enzymatic detergent (pH 6.0–8.0). Repeat as necessary until all visible soil is removed. • Dry all surfaces of the bone mill base thoroughly with a clean cloth. • Caution: Do not immerse or soak the bone mill base. 3
EN Sterilization of base
These sterilization guidelines are only recommended guidelines and may vary among hospitals depending upon the type of sterilization equipment and possible pathogens in their particular areas. These guidelines represent exposure time and not total cycle time. The recommended sterilization parameters may be modified based on standard hospital sterilization protocol. Cycle type
Gravity displacement
High Vacuum Steam (pre-vacuum)
High Vacuum Steam (pre‑vacuum, UK)
Temperature
270°F/132°C
270°F/132°C
273°F/134°C
Exposure time
25 minutes
4 minutes
3 minutes
Drying time
8 minutes
8 minutes
8 minutes
Wrapped/ unwrapped
Wrapped/unwrapped
Wrapped/unwrapped
Wrapped/unwrapped
Note: The temperatures and times for sterilization are the minimum required. Legend™ 100% Ethylene Oxide (EO) sterilization parameters
For Items Contaminated With TSE Agents
Preconditioning
Sterilization temperature
Relative humidity
EO concentration
Gas exposure (full-cycle)
Aeration
51-59 °C (124‑138 °F), 70 ± 5 % relative humidity, Time: 30 minutes (30:00)
51-59 °C (124-138 °F)
70 ± 5 %
725 ± 25 mg/L
4 hours
51-59 °C (124-138 °F), 18 hours
Medtronic recommends incineration of devices that have directly contacted patients suspected or confirmed with a Transmissible Spongiform Encephalopathy (TSE)/ Creutzfeldt-Jakob disease (CJD) diagnosis.
Return policy for devices exposed to Transmissible Spongiform Encephalopathies (TSE) Medtronic Powered Systems Solutions (MPSS) will not authorize or accept the return of MPSS products that directly contact patients or is contaminated with a patient’s body fluids who is suspected or confirmed with a Transmissible Spongiform Encephalopathies / Creutzfeldt-Jakob Disease (TSE/CJD) diagnosis. Furthermore, MPSS recommends that all MPSS products used on a patient confirmed with a TSE diagnosis be incinerated. Contact your Sales Representative for replacement of product incinerated under this policy or for temporary equipment while original equipment is quarantined. Contact MPSS Regulatory Affairs Department for additional information regarding TSE contamination. MPSS dissecting tools used on a patient suspected of a TSE/CJD diagnosis must be incinerated. If TSE/CJD is excluded as a diagnosis, the quarantined reusable equipment may be returned for use after appropriate cleaning, decontamination and sterilization. Hospital personnel should contact their infection control personnel for current procedures and policy for reusable equipment processing when suspect of contamination with Creutzfeldt-Jakob Disease (CJD) or other Transmissible Spongiform Encephalopathies (TSE). Reusable devices that have been used on patients with suspected Creutzfeldt-Jakob Disease (CJD) or other Transmissible Spongiform Encephalopathies (TSE) should be quarantined and not reused until diagnosis is confirmed or excluded. Reusable devices should be quarantined after having been cleaned, decontaminated, sterilized and packed in a ridged sealed container until final diagnosis.
Preventative maintenance The Pneumatic Bone Mill Attachment should be returned for factory maintenance annually (approximately 100 procedures). If the Pneumatic Bone Mill Attachment does not function according to these instructions, contact your Medtronic regional distributor or Medtronic neurologic sales representative.
Reorder information Catalog #:
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BM100
Legend™ Pneumatic Bone Mill Attachment
BM200
Legend™ Bone Mill Disposable, Single Blade
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Limited warranty* (U.S. Customers Only) A.
This Limited Warranty provides the following assurance to the original purchaser of a Medtronic Midas Rex™ Legend™ Pneumatic Bone Mill. The Midas Rex™ Legend™ Pneumatic Bone Mill includes Base and the Disposable Bowl, Cap and Spatula (hereafter referred to as “Accessory” or “Accessories”) and jointly referred to as Midas Rex™ Legend™ Pneumatic Bone Mill, unless specifically noted. Should (1) the Base fail to function within normal tolerances due to a defect in materials or workmanship within a period of 1 year from the date of shipment of the new Base, or 180 days from the date of shipment of the serviced or refurbished Base to the purchaser (but not less than the 1 year period from the date of shipment of the new Base), or (2) an Accessory fail to function within normal tolerances due to a defect in materials or workmanship within a period of 90 days from the date of shipment of a new Accessory or serviced or refurbished Accessory to the purchaser, then Medtronic will at its option replace the Midas Rex™ Legend™ Pneumatic Bone Mill or any portion thereof, or, credit purchaser for the net amount actually paid for any such Accessory or Base.
B.
To qualify for this LIMITED WARRANTY, the following conditions must be met:
C.
1.
The Midas Rex™ Legend™ Pneumatic Bone Mill must be used in accordance with the labeling and Instruction Manual provided with the products.
2.
Only Midas Rex™ Legend™ Pneumatic Bone Mill Accessories that are manufactured, authorized, and quality controlled by Medtronic may be used.
3.
No reprocessed Accessory sets may be used.
4.
The Midas Rex™ Legend™ Pneumatic Bone Mill may not be damaged by accident, abuse, misuse or tampering.
5.
The Midas Rex™ Legend™ Pneumatic Bone Mill or Midas Rex™ Legend™ Pneumatic Bone Mill Accessories may not be modified without the written permission of Medtronic.
This Limited Warranty is limited to its express terms. In particular: 1.
EXCEPT FOR THE LIMITED WARRANTY PROVIDED IN (A) ABOVE, MEDTRONIC GRANTS NO OTHER WARRANTIES OR CONDITIONS, EXPRESS OR IMPLIED AND MANUFACTURER SPECIFICALLY DISCLAIMS THE IMPLIED WARRANTIES AND CONDITIONS OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. MEDTRONIC NEITHER ASSUMES NOR AUTHORIZES ANY OTHER PERSON TO ASSUME ANY OTHER LIABILITIES ARISING OUT OF OR IN CONNECTION WITH THE SALE OR USE OF ANY PRODUCT. IN NO EVENT SHALL MEDTRONIC BE LIABLE FOR ANY CONSEQUENTIAL, INCIDENTAL, PROSPECTIVE OR OTHER SIMILAR DAMAGE RESULTING FROM A DEFECT, FAILURE, OR MALFUNCTION OF THE PRODUCT, WHETHER A CLAIM FOR SUCH DAMAGE IS BASED UPON WARRANTY, CONTRACT, NEGLIGENCE OR OTHERWISE.
2.
The exclusions and limitations set out above are not intended to, and should not be construed so as to contravene mandatory provisions of applicable law. If any part or term of this Limited Warranty is held to be illegal, unenforceable or in conflict with applicable law by a court of competent jurisdiction, the validity of the remaining portions of the Limited Warranty shall not be affected, and all rights and obligations shall be construed and enforced as if this Limited Warranty did not contain the particular part or term held to be invalid. This Limited Warranty gives the purchaser specific legal rights. The purchaser may also have other rights that vary from state to state.
3.
No such express or implied warranty to the purchaser shall extend beyond the period specified in A, above.
4.
This Limited Warranty shall be the exclusive remedy available to any person.
*This Limited Warranty is provided by Medtronic, 4620 North Beach Street, Fort Worth, Texas 76137. It applies only in the United States. Areas outside the United States should contact their local Medtronic representative for terms of the warranty.
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Medtronic Powered Surgical Solutions 4620 North Beach Street Fort Worth, TX 76137 USA 1 800 643 2773
Authorized Representative in the European Community Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands +31 45 566 8000 Australian Sponsor Medtronic Australasia Pty Ltd 2 Alma Road Macquarie Park, NSW 2113 Australia
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