Pneumatic High Performance Instrument Systems Instructions

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Contents General Information...2 System Assembly...6 System Operation...7 System Shutdown...8 Additional Information...8 Trouble Shooting...9

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General Information Device Description

Pneumatic High Speed Drill Systems for use with Anspach Attachments and Dissection Tools

Indications for Use

Cutting and shaping bone.

Cleaning and Sterilization • • •

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Prior to first use the equipment must be processed as per the included Anspach Cleaning and Sterilization instructions. At the point of use the device must be cleaned as soon as possible after use to prevent drying of blood, tissue, other biological debris and contaminants on the device. Refer to the Anspach Cleaning and Sterilization instructions accompanying this device.

Symbols

Consult Operating Instructions

Direction of rotation

Keep Dry (A.K.A. Protect from Moisture)

Direction of rotation for lock position

Indicates position, alignment, or location.

Indicates setting, position, or location.

Direction of rotation

Indicates setting, position, or location.

Indicates position or location

Direction of rotation

CAUTION: Refer to accompanying documentation

Indicates action of rotation and position for Secure (LOCK) and Release (UNLOCK).

Symbol with yellow background: CAUTION: Refer to accompaning documentation.

Indicates the attachment setting, refer to MA-DRIVER & MA-D20 section in this document for further details

Indicates the drill tip exposure

Direction of rotation for lock position

Located on the Handpiece this indicates position of the knurl knob to the desired location.

Lock (Run) Humidity Limits

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Anspach Product Icon

Unlock (Load) 00/0000

Use By Date (A.K.A. Expiration Date, Expiry)

Temperature Limits

Sterile unless damaged or open

CE Mark (A.K.A. CE Mark [notified body number], Conformité Européenne) Meaning: Device complies with applicable EEC Directives

United States Federal law restricts this device to sale by or on the order of a physician or other licensed health-care provider

Reference Number (A.K.A. Item Number, Catalog Number, Part Number)

Lot (A.K.A. Lot Number, Batch Number, Batch Code)

Serial Number

Quantity

Manufacturer

Authorized European Union Representative

Sterilized Using Irradiation

Single Use Only (A.K.A. Do Not Reuse)

Date of Manufacture

(01)

Global Trade Item Number (GTIN)

(10)

Batch or Lot Number

(17)

Expiration Date

(21)

Serial Number

GTIN

Global Trade Item Number

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Warnings • • • • • • • • • • • • • • • • • • • • • • • • • • • • •

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Always use continuous irrigation to prevent heat build-up. Irrigation is necessary for proper performance. HANDPIECE’S OUTER HOSE CAN RUPTURE WITHOUT WARNING IF OCCLUDED. DO NOT STEP ON, SET EQUIPMENT ON, PINCH, KINK, CLAMP, OR OTHERWISE OCCLUDE HANDPIECE HOSE DURING USE. Surgeon is responsible for learning proper techniques in use of equipment; improper use may cause serious injury to user or patient or damage to system. Instrument operator and all operating room personnel must wear eye protection. Visually inspect for damage before using; do not use if damage is evident. Do not use if the product sterilization barrier or its packaging is compromised. Do not use, or discontinue use of powered equipment exhibiting excessive temperatures that can cause patient injury (necrosis) and/or user discomfort. Use of damaged or improperly maintained power equipment and/or misused powered equipment can result in excessive temperatures. Use caution to avoid cutting or tearing gloves while handling dissection tools. Dissection tools must be adequately retained within attachment to prevent distal migration, which may cause injury. Confirm attachment is proper size for dissection tool and that it is secure. Gently pull on dissection tool shaft to ensure it is fully seated and properly installed. Use standard protocol for disposal of sharp instruments. Continuous extreme cutting at or near stalling conditions will quickly overheat handpiece. Do not operate in an explosive flammable environment. Do not use in oxygen rich environment. No modification of this equipment is allowed. Dispose of items contaminated with body fluids with other biohazardous waste. At end of life recycle or dispose of device in accordance with local and national regulations. Inspect system for damage, pressure relief valve for cracks and hose for cuts or abrasions before using; do not use if damage is evident. Do not use excessive force. Do not force dissection tool while performing operation. Forceful side loading of dissection tool may cause fracture of dissection tool, which may cause injury. Dissection tools are disposable and intended for single patient use only. Do not re-sterilize and/or re-use dissection tools. Confirm attachment is proper size for dissection tool and that it is secure. Delicate structures in proximity to dissection must be thoroughly protected to prevent injury. Maintain firm control of instrument at all times. Do not bend or use as a lever. Use a gentle tapping motion or side-to-side motion and let instrument do cutting. Only cut visible areas unless an image intensifier is utilized.

Cautions • •

• • • • •

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•

United States Federal law restricts this device to sale by or on order of a physician or other licensed healthcare provider. Do not use accessories other than those provided by DePuy Synthes Power Tools and specified for use with Anspach Systems. To insure equipment operates as designed, read and follow manufacturer’s instructions. Do not operate handpiece without an attachment and the corresponding dissection tool. Only Anspach Dissection Tools should be used with these systems. (e.g Only Use BlackMax Burrs with BlackMax Attachments.) Use care to protect hose when handling, cleaning, and during system use. Damage to hose can cause leaking, rupture, or other related failures. Do not engage safety mechanism while handpiece is running; doing so makes safety mechanism inoperable.

Latex Information

Not made with natural rubber latex.

Warranty & Return Policies

Warranty and return policy is available upon request. Warning: All Instrument System components returned for servicing or repair should be properly cleaned and sterilized as applicable prior to shipping.

Warning: Transmissible Spongiform Encephalopathies (TSE)

DePuy Synthes Power Tools will not authorize or accept the return of products that directly contact patients or are contaminated with a patient’s body fluids who is suspected or confirmed with a Transmissible Spongiform Encephalopathies/ Creutzfeldt-Jakob Disease (TSE/CJD) diagnosis. DePuy Synthes Power Tools recommends that all Anspach products used on a patient confirmed with a TSE/CJD diagnosis be incinerated. Anspach Dissection Tools used on a patient suspected of TSE/CJD diagnosis must be incinerated. Contact your Sales Representative for replacement of product incinerated under this policy or for temporary equipment while original equipment is quarantined. Contact the DePuy Synthes Power Tools Customer Service Department regarding TSE/CJD contamination for additional information.

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System Assembly

AutoLube and Handpiece Assembly

1. Remove the red plug (installed for shipping only) from the recirculating bowl located at the top of the AutoLube. 2. Rotate locking knob (located on back of AutoLube) towards “OPEN” position. 3. While maintaining the handle in the “OPEN” position, insert muffler end of pneumatic handpiece into the cavity located on top of the recirculating bowl. 4. Insert the muffler until red ring on muffler cannot be seen. 5. Rotate silver handle to the “LOCK” position. Check for secure engagement.

Operating Pressure

Anspach pneumatic handpieces run on air or medical grade nitrogen. Standard operating pressure is 90–120 psi (6.2–8.3 bar). If more or less power is desired, the psi may be regulated between 40 and 140 psi (2.8 and 9.6 bar). 1. Connect air hose from AutoLube to hospital air source, nitrogen tank or nitrogen system. 2. Adjust air source until desired pressure registers on gauge of AutoLube. Pressure will not register on AutoLube until foot pedal is activated. 3. The wall/nitrogen tank pressure may read as much as 40 psi (2.8 bar) higher than the AutoLube gauge. Note: Handpiece is fully functional at this time.

Special Operating Pressures for Attachments: B-ORANGE-45 run at 40 psi (2.8 bar) B-ORANGE-90 run at 40 psi (2.8 bar)

Special Operating Pressures for Dissection Tools: SIL-DS-A run at 70 psi (4.8 bar) SHD-DS-A run at 70 psi (4.8 bar)

Pressure Relief Valve

Note: Handpiece hose may include a pressure relief valve to remove excess pressure in the case of hose occlusion between the AutoLube and the valve. If the pressure relief valve is actuated during use, remove the source of the occlusion. Do not attempt to disassemble the pressure relief valve.

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AutoLube Lubrication

Note: The AutoLube has been delivered without oil or a filter installed. A bottle of Anspach lubricating oil, filter, and muffler have been shipped with the unit and must be added to the AutoLube prior to use.

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1. Before adding oil, disconnect the AutoLube from the air source. 2. Remove Oil Fill Cap from the top of the AutoLube and fill with Anspach lubricating instrument oil provided. Do not fill above the “MAX” oil level line next to the oil reservoir. Always replace the oil fill cap securely. One full bottle of Anspach lubricating oil should be added when the oil level reaches the “MIN” oil level line etched next to the oil reservoir. 3. Before each use, a visual check of the oil reservoir should be made to ensure there will be an adequate supply of oil to circulate throughout the procedure. 4. Install filter and muffler following “AutoLube Filter” section.

AutoLube Filter

The filter, muffler filter, and vented cover have been packed separately in the AutoLube box. The filters should be changed each time a bottle of Anspach lubricating oil is added. 1. Insert the filter by taking the tab and sliding the “horseshoe” shaped portion of the filter into the cavity in a downward motion. The tab will extend out of the cavity. 2. Push muffler filter into vented cover with the hole in muffler filter centered over the attachment screw. The muffler is oversized and must be compressed to fit. 3. Place the vented cover over the filter cavity and secure by turning the grey wingnut in a clockwise direction.

System Operation BlackMax Operation

Caution: Firm control of the BlackMax must be maintained at all times. Never force the dissection tool. Let the instrument do the cutting. Never use the attachments as a retractor to bend or pry. Only Anspach BlackMax dissection tools should be used with the BlackMax.

BlackMax Directional Features

The words “SECURE” and “RELEASE” engraved on the side of the BlackMax handpiece refer to the locking and unlocking the attachment onto the handpiece. The Lever, located on the top of the handpiece, is used to lock and unlock dissection tools within the handpiece. Caution: If the dissection tool is not inserted properly, the Lever will not secure the dissection tool. Do not force the Lever. For instructions on attachment assembly, refer to the specific instructions for each attachment in this manual.

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XMax and XMax-H Operation

Caution: Firm control of the handpiece must be maintained at all times. Never force the dissection tool. Let the instrument do the cutting. Never use the attachments as a retractor to bend or pry. Only Anspach XMax dissection tools should be used with the XMax and XMax-H.

XMax Directional Arrows

Notice the directional arrows and printing on the distal end of the handpiece housing: “RUN” ( ), “LOAD” ( ) and “SAFE.” These terms refer to locking and unlocking the attachment and dissection tool onto the handpiece. For instructions on attachment assembly, refer to the specific instructions for each attachment in the provided Directions for Use (DFU).

System Shutdown

Handpiece and AutoLube Disassembly

1. Turn off hospital air source connected to AutoLube. 2. Depress foot pedal until all air has been removed from handpiece and AutoLube. 3. Disconnect AutoLube air hose from hospital air source. 4. Rotate locking knob towards “OPEN” position and remove muffler end of pneumatic handpiece from AutoLube (refer to operating manual for attachment and cutting burr disassembly).

Additional Information End of Life

Return all equipment for proper disposal.

Recommended Manufacturer Service Interval

It is recommended that the equipment be returned to DePuy Synthes Power Tools at a minimum every 12 months for full product inspection and service.

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Trouble Shooting Trouble Shooting Chart Possible Cause Possible Solution 1. Inadequate lubrication 1. Add Anspach oil to 2. Inadequate operating AutoLube. pressure 2a. Check pressure on 3. Muffle not connected AutoLube. Extra long properly extension hose from air 4. Handpiece hose source could reduce damage operating pressure. 5. Faulty internal 2b. Check hose connector. component (e.g Schrader) 6. Pressure Relief Valve 2c. Check for handpiece activated hose occlusion. 3. Check connection between muffler and AutoLube Muffler must be inserted past red line. 4. Return attachment to DePuy Synthes Power Tools for service. 5. Return attachment to DePuy Synthes Power Tools for service. 6. Check for handpiece occlusion, remove the source of the occlusion. Return attachment to DePuy Synthes Power Tools for service. Handpiece 1. Handpiece stalling 1. Rotate dissection tool, 2. Faulty attachment then activate foot pedal. does not 2. Clean or replace rotate when 3. Handpiece lock engaged attachment. foot pedal 3. Unlock handpiece. is activated 4. Faulty internal component 4. Return attachment to DePuy Synthes Power Tools for service. Handpiece 1. Inadequate lubrication 1. Add Anspach oil to AutoLube. vibration or 2. Handpiece out of balance. 2. Return to DePuy extremely Synthes Power Tools hot. for service.

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Problem Lack of power or excessive handpiece noise.

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English Trouble Shooting Chart Possible Cause Possible Solution 1. Dissection tool may 1. Replace with new be bent. dissection tool. 2. Dissection tool may not 2. Reassemble dissection be fully seated. tool and attachment. 3. Improper attachment 3. Only use correct and dissection tool dissection tool with combination. appropriate attachment. 4. Possible attachment 4. Return to DePuy bearing damage. Synthes Power Tools for service. BlackMax 1. Dissection tool not 1. Remove dissection tool seated properly and attachment. Lever will 2. Debris built up inside 2. Remove attachment, lift not lower handpiece lever, and tap distal tip 3. Broken dissection tool of handpiece against in handpiece hard surface until debris is dislodged. 3. Lift lever, tap distal tip of handpiece against hard surface until dissection tool is dislodged. XMax 1. Dissection tool not 1. Remove dissection tool seated properly and attachment. knurled 2. Debris built up inside 2. Remove attachment knob will handpiece and tap distal tip of not secure 3. Broken dissection tool handpiece against hard in handpiece surface until debris is dislodged. 3. Remove attachment and tap distal tip of handpiece against hard surface until dissection tool is dislodged. Attachment 1. Debris lodged inside 1. Clean attachment using attachment. Anspach Attachment is hot. 2. Possible bearing Cleaning Instructions. damage. 2. Return attachment to DePuy Synthes Power Tools for service. Craniotome 1. Excessive force used in 1. Do not use, replace operation. attachment. attachment is bent. Problem Excessive vibration of dissection tool.

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Trouble Shooting Chart Possible Cause Possible Solution 1. Oil leaking out of 1. Replace AutoLube filter, AutoLube check oil level. Do not 2. Faulty air connection overfill AutoLube. 3. AutoLube was sterilized 2. Check connection at air or submerged in fluids source. 4. Water in the AutoLube 3. Return to DePuy Synthes Power Tools for service. 4. Return to DePuy Synthes Power Tools for service.

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Problem Inoperative Foot Control

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Manufacturer

The Anspach Effort, Inc.

4500 Riverside Drive Palm Beach Gardens, FL 33410 USA Tel: (800) 327 6887 / +1 561 627 1080 Fax: (800) 327 6661 / +1 561 625 9110 Web: www.depuysynthes.com Email: [email protected]

Synthes GmbH

Eimattstrasse 3 4436 Oberdorf Switzerland Tel: +41 61 965 61 11 Fax: +41 61 965 66 00 The BlackMax System is not sponsored by, endorsed by or otherwise associated with United States Manufacturing Corp. or its BlackMax prosthetic limbs.

18-0040 Rev. H 11/19 For patent information go to http://www.depuysynthes.com/patentmarking © DePuy Synthes 2019. All rights reserved.