Anspach Pneumatic System Instructions for Use rev A Aug 2011

Table of Contents

Introduction

Operating Instructions

Attachments and Dissection Tool Assembly

Information

Synthes Anspach

2

Pneumatic Instrument Systems

2

Indications

3

Warnings and Cautions

4

Technical Specifications

5

Glossary of Symbols

6

AutoLube III

7

Black Max

10

XMax and microMax

11

iMRI Instrument System

12

Straight Attachments and Dissection Tool Assembly For Black Max

15

For XMax and microMax

17

Minimal Access Attachments and Dissection Tool Assembly

23

Micro Curved Attachment

25

microSaws and Small Attachments Assembly

26

Handheld Attachments Assembly

29

Anspach Powered Irrigation System

32

Cleaning and Maintenance

34

Sterilization

37

Troubleshooting

38

Ordering Information

39

Warranty and Return Policies

41

Anspach Pneumatic Systems User’s Manual

Synthes

Anspach Pneumatic Systems. High speed performance and power in a variety of applications.

Synthes Anspach Synthes Anspach manufactures pneumatic and electric high performance instruments and attachments to meet the specific needs of both surgeon and staff. While the advanced design of these instruments provides unparalleled performance and reliability, they also allow for effortless assembly, meeting the needs of both surgeon and staff for the most demanding applications. No tools are required to assemble dissection tools or attachments. All Synthes Anspach instruments are manufactured to conform to rigorous quality standards to provide dependable performance. Important: Before using any of the Synthes Anspach High Performance Systems, it is imperative that all individuals working with the system read this operating manual. The surgeon is responsible for learning the proper techniques in the use of this system, as improper use may cause injury. To schedule a hands-on training course, either at Synthes Anspach or from your local Synthes Anspach Sales Representative, call (800) 327-6887 or (561) 627-1080. If you have any questions after reading this manual, please call the Synthes Anspach Customer Service Department at (800) 327-6887 or (561) 627-1080.

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Pneumatic Instrument Systems The XMax® sets a new standard for the ultimate combination of high power, smooth operation, low noise level, and small size. This new level of performance provides the perfect pneumatic system to handle a complete range of surgical procedures ranging from power demanding applications to the most delicate dissection. With a minimum speed of 80,000 rpm at 120 psi (8.3 bar) input pressure, the XMax system is one of the quietest pneumatic handpieces available, with 35% more power than Black Max and 50% more than microMax Plus. The microMax Plus operates at 80,000 rpm. It is small and lightweight to minimize fatigue for long procedures. It has 60% more power than microMax. The Black Max, operating at 80,000 rpm at 120 psi (8.3 bar), offers smooth, controlled bone dissection. The iMRI Instrument System provides an Intraoperative MRI compatible configuration. The iMRI Instrument System utilizes non-magnetic materials in the handpiece, attachment, and dissection tool components that have been approved for use with field strengths up to 1.5 Tesla.

Indications

XMax Cutting and shaping bone Black Max Cutting and shaping bone microMax Cutting and shaping bone iMRI Surgical Drill System The Anspach iMRI Surgical Drill System (including pneumatic drill motor, foot control, nosepiece attachments and cutters), is indicated for intraoperative (non-imaging) use within a Magnetic Resonance Imaging (MRI) environment rated at 1.5 Tesla or less, for surgical cutting, shaping an iMRI removal of bone, including bones of the skull and spine.

Spine surgery

Neurosurgery and ENT

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Warnings and Cautions

United States Federal law restricts this device to sale by or on order of a physician or other licensed healthcare provider. 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 accessories other than those provided by Anspach and specified for use with Anspach systems. Use care to protect hose when handling, cleaning, and during system use.

Do not operate handpiece without an attachment and the corresponding dissection tool. (i.e. Only use Black Max cutting burrs with Black Max attachments.) 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. Do not engage safety mechanism while handpiece is running; doing so makes safety mechanism inoperable.

Damage to hose can cause leaking, rupture, or other related failures.

Only cut visible areas unless an image intensifier is utilized.

Handpiece’s outer hose can rupture without warning if occluded.

Delicate structures in proximity to dissection must be thoroughly protected to prevent injury.

Do not step on, set equipment on, pinch, kink, clamp, or otherwise occlude handpiece hose during use.

Irrigation is necessary for proper operation.

Do not use if pressure relief valve has cracks or hose has cuts or abrasions. 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. To ensure equipment operates as designed, read and follow manufacturer's instructions, including those for proper service and maintenance.

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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. Do not use excessive force. 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 resterilize and/or reuse dissection tools. Use standard protocol for disposal of sharp instruments.

Technical Specifications

BM

MM

Black Max Specifications* Speed Handpiece, muffler, hose Outside housing (diameter) Length of housing Handpiece weight Handpiece, muffler, hose weight

up to 80,000 rpm 3.81 m (12.5 ft) 19 mm (.75 in) 91 mm (3.6 in) 70 gms (2.6 oz) 0.65 kg (1.4 lbs)

microMax Specifications Speed Handpiece, muffler, hose Outside housing (diameter) Length of housing Handpiece weight Handpiece, muffler, hose weight

XM

MM

XMax Specifications Speed Handpiece, muffler, hose Outside housing (diameter) Length of housing Handpiece weight Handpiece, muffler, hose weight

up to 80,000 rpm 3.81 m (12.5 ft) 17.4 mm (.685 in) 102.02 mm (4.025 in) 75.3 gms (2.7 oz) 0.65 kg (1.45 lbs)

microMax Plus Specifications Speed Handpiece, muffler, hose Outside housing (diameter) Length of housing Handpiece weight Handpiece, muffler, hose weight

The device complies with the following standards: IEC 60601-1 / IEC 60601-1-2 IEC 61000-3-2 / IEC 61000-3-3 / IEC 61000-4/2 / IEC 61000-4-4 / IEC 61000-4-5 / IEC 61000-4-11 / IEC 61000-4-8 / IEC 61000-4-6 / IEC 61000-4-3

With regard to electrical shock, fire, mechanical hazards, this device is certified to UL 60601-1 and CAN/CSA C22.2 No. 601.1 This device complies with applicable EEC directives.

up to 80,000 rpm 3.81 m (12.5 ft) 15.8 mm (.625 in) 89 mm (3.5 in) 56.70 gms (2 oz) 0.5 kg (1.1 lbs)

up to 80,000 rpm 3.81 m (12.5 ft) 15.8 mm (.625 in) 95.25 mm (3.75 in) 75.3 gms (2.7 oz) 0.65 kg (1.4 lbs)

iMRI

iMRI Handpiece Speed Handpiece and Hose Outside Housing (diameter) Length of Housing Handpiece and hose weight

10,000-75,000 rpm 3.81 m (12.5 ft) 17.5 mm (.69 in) 101 mm (4 in) 635 gms (1.41 lb)

Patent Information Synthes Anspach products are manufactured under one or more of the following U.S. Patent Nos. RE 37,358; 5,405,348; 5,601,560; 5,630,818; 5,741,084; 5,904,687; 6,607,533; 6,733,218; 6,746,153; 6,749,341; 6,969,368; 7,128,544; 7,144,415; 7,217,090; 7,255,546; 7,261,526 and 7,458,979. Additional U.S. and International patents pending. Additional Information All specifications are subject to change.

* The Synthes Anspach Black Max Instrument System is not sponsored by, endorsed by or otherwise associated with United States Manufacturing Corp. or its Blackmax prosthetic limbs.

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Glossary of Symbols

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

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

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

MR Conditional. No known hazards at 1.5T. Serial Number

1.5T

Lock (Run) 00/0000

Use By Date (A.K.A. Expiration Date, Expiry) Unlock (Load) Manufacturer Transmitter Interference may occur in the vicinity of equipment marked with this symbol.

Authorized European Representative Sterile R (A.K.A. Sterilized Using Irradiation)

Type B Electrical Equipment Single Use Only (A.K.A. Do Not Reuse) Attention (A.K.A. Caution, Warning, Danger, Important, Note, Refer to Accompanying Documentation)

Instrument System Key

BM Black Max

MM microMax Plus

XM XMax

iMRI

iMRI

Keep Dry (A.K.A. Protect from Moisture) Sterile unless damaged or open United States Federal law restricts this device to sale by or on the order of a physician or other licensed health-care provider.

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Latex-free Certification There is no latex material in Synthes Anspach products or packaging.

AutoLube III Operating Instructions For Black Max, XMax and microMax

Assembly Procedures of AutoLube III and Handpiece

1

AUTOLUBE-III Foot Control For additional part numbers, refer to the "Components" section 1. Remove the red plug (installed for shipping only) from the recirculating bowl located on the top of the AutoLube III. 2. Turn the silver handle located on the back of the AutoLube III to the “OPEN” position. 3. While maintaining the handle in the “OPEN” position, insert the muffler end of the pneumatic handpiece into the cavity located on top of the recirculating bowl. 4. Insert the muffler until the red ring on the 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 (8.3 bar). If more or less power is desired, the psi may be regulated between 40 and 140 psi.

Oil Fill Cap

Pressure Gauge

Open Position

2

Silver Handle

3, 4

1. Connect the air hose from the AutoLube III to the hospital air source, nitrogen tank or hospital nitrogen system. 2. Adjust the air source until the desired air pressure registers on the gauge of the AutoLube III. Pressure will not register on the AutoLube III until the muffler is inserted and the foot pedal is activated. 3. The wall/nitrogen tank pressure may read as much as 40 psi higher than the AutoLube III gauge. Handpiece is fully functional at this time.

Red Plug/ Recirculating Bowl

Red Ring inserts fully into Recirculating Bowl

Locked Position

5

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AutoLube III Operating Instructions

Pressure Relief Valve

Pressure Relief Valve

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. AutoLube Lubrication OIL-II Instrument Oil with 1 Replacement Filter The AutoLube III 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 III prior to use. 1. Before adding oil, disconnect the AutoLube III from the air source. 2. Remove Oil Fill Cap from the top of the AutoLube III and fill with Anspach lubricating instrument oil (OIL-II). 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.

Turn handle to open position to insert muffler

Oil Fill Cap

Oil Reservoir

AutoLube Lubrication 1.

2.

4.

5.

3.

Max. Oil Level Min. Oil Level

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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-III Filter” section.

AutoLube Filter

Vented Cover

Note: Always store and transport AutoLube III in an upright position.

AutoLube III Filter FILTER-II AutoLube II & III Filters (5/pkg.) The filter, muffler filter, and vented cover have been packed separately in the AutoLube III 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.

Insert filter with a downward motion

Filter Vented Cover

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Black Max Operating Instructions

The Black Max Handpiece BM BLACKMAX-N Swivel/Angle Motor Assembly BLACKMAX-O Fixed/Straight Motor Assembly BLACKMAX-N-LP Low Pressure Swivel/Angle Motor Assembly BLACKMAX-NS Neuro Safety BLACKMAX-NS-LP Low Pressure Neuro Safety

Attachment Connection

Lever

Motor Housing/ Handpiece

Operation Important: Firm control of the Black Max 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.

Release Cutter

Lock Cutter

Lever

Only Anspach Black Max dissection tools should be used with the Black Max. Always use continuous irrigation to prevent heat build-up. Always wear safety glasses. Black Max Directional Features The words “SECURE” and “RELEASE” engraved on the side of the Black Max 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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Black Max Handpiece

Distal End

XMax and microMax Operating Instructions

The XMax and microMax Handpieces XM XMAX MICROMAX MICROMAX-LP MICROMAX-PLUS MICROMAX-PLUS-LP

XMax Motor microMax Motor microMax Motor, Low Pressure microMax Plus Motor microMax Plus Motor, Low Pressure

XMax Handpiece Distal End

Handpiece Knurled Knob

Directional Arrows

Operation Important: 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.

Figure 1

Only Anspach XMax/microMax dissection tools should be used with the XMax and microMax. Always use continuous irrigation to prevent heat build-up. Always wear safety glasses.

XM 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 (Figures 1 and 2). For instructions on attachment assembly, refer to the specific instructions for each attachment in this manual.

Figure 2

microMax Handpiece

Distal End

MM microMax Directional Arrows Notice the directional arrows and printing on the side of the handpiece at the distal end: “SECURE” and “RELEASE.” These terms refer to locking and unlocking the attachment and dissection tool onto the handpiece (Figure 3).

Handpiece Knurled Knob

Directional Arrows

Figure 3

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iMRI Instrument System

iMRI Instrument System

iMRI

IMRI-MOTOR iMRI Motor IMRI-FOOT-CTRL iMRI Air Control IMRI-SHORT iMRI Short Attachment IMRI-SHORT-HD iMRI Short HD Attachment IMRI-CRANI-A iMRI Crani-A Attachment IMRI-OIL iMRI Synthetic Oil For additional components, refer to page 40. Use, Care and Operating Instructions Important: Do not use any attachments or cutters with iMRI handpiece not manufactured by Anspach, or not identified as “iMRI.” Do not operate handpiece without attachment and cutter installed. United States Federal law restricts this device to sale by or on order of a physician or other licensed health-care provider. Read and understand thoroughly before operating your new iMRI Instrument System. Failure to do so could lead to injury to you or your patient or cause severe damage to this equipment. The iMRI Instrument System is a design modification of the Anspach microMax System. Refer to the “XMax and microMax Operating Instructions” section for additional assembly instructions. iMRI System and cutters are constructed of materials that permit intraoperative use in an iMRI unit rated at 1.5 Tesla or less and only when iMRI is not being used for actual imaging purposes. Caution: Do not use in iMRI units rated at greater than 1.5 Tesla. Remove iMRI System from iMRI imaging volume during imaging. Failure to do so could result in unacceptable image noise and/or distortion.

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Testing of iMRI System as established by ASTM F2213-02 “Standard Test Method for Measurement of Magnetically Induced Torque on Passive Implants in Magnetic Resonance Environment” and F2052-02 “Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in Magnetic Resonance Environment” confirm there is no detectable magnetically induced torque on handpiece at 1.5 Tesla (when tested in a 1.5T magnet) and only slight deflection force (10° with 18% of force due to gravity) when subjected to a high field strength and high field gradient location (1.5 Tesla) when tested in a Siemens 1.5T Magnetom Symphony, Maestro Class Unit. iMRI System is designed for surgical procedures typically involving no more than 15 minutes of continuous (actively drilling) operation. If a procedure is expected to last longer, you should be aware handpiece speed and temperature may be affected. Normal speed of iMRI System will be less than microMax due to magnetic effects of iMRI and because iMRI System does not have continuous oiling. The lower speed will not adversely affect your ability to perform procedure and you will experience little to no magnetic pull on handpiece during use. However, the following effects may be noted: 1. Handpiece speed will slow when handpiece rotating mechanism is held 90° to magnetic field. 2. Handpiece temperature will increase when handpiece is held in 90° position for greater than 5 minutes. Handpiece should not become uncomfortably warm during normal use; procedures lasting greater than 15 minutes could cause handpiece temperature to rise. 3. Lock mechanisms of iMRI System and cutters are essentially the same as microMax. However, to help prevent unintended use of non-iMRI devices, geometry has been slightly modified to prohibit attachment of non-iMRI handpiece compatible devices.

Important: Attempts to attach microMax components to iMRI handpiece could result in significant damage to iMRI Handpiece. Straight attachments should be used for no more than 10 procedures. Craniotome attachments should be used for no more than five procedures. Attachments are not repairable and should be replaced after the recommended number of uses. Metal component parts of iMRI handpiece and attachments, and all iMRI cutters are constructed of materials mostly unaffected by magnetic properties of iMRI. However, these materials have significantly less hardness, which directly affects durability. Proper use, cleaning, maintenance and preoperative inspection will help ensure safe use and prolong useful life of iMRI handpiece and attachments. Periodic routine servicing by Anspach is strongly recommended. iMRI cutters will dull more quickly than standard cutters because they are manufactured of nonmagnetic reactive material. Use with iMRI only. During surgical use, you should remain cognizant of cutter performance and have additional cutters available at all times. Continued use of dull cutters, in addition to possible necroses, may put additional stress on attachment and handpiece, leading to premature failure of those devices. Before each use, assemble system and test to ensure proper performance. Proper system performance is usually indicated when there is no unusual difficulty in attaching attachments and cutters, and when system operates at full speed (unloaded with cutter attached) with no unusual noise, vibration, wobble or whipping. Important: Carefully inspect handpiece and attachments postcleaning and again preoperatively to ensure there is no corrosion or remaining debris which could adversely affect operation or lead to attachment bearing failure during use. Continued use of damaged or worn handpiece or attachments can lead to bearing (or other) failures, which can result in foreign debris entering surgical wound site. Never reprocess or reuse iMRI cutters. iMRI cutters must be properly disposed of after single use.

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iMRI Instrument System

iMRI Operating Instructions Warning: Do not run handpiece without cutter and attachment installed. 1. Foot control must be placed on floor within reach of surgeon. Foot control is not subject to sterilization so should never be placed such that sterile field is compromised. 2. Place three (3) drops of iMRI OIL into muffler end of iMRI handpiece hose assembly. Do not exceed three (3) drops. Important: iMRI OIL is for use with iMRI Handpiece only. Do not use with other Anspach “Autolube” systems. iMRI OIL used in AutoLube can damage the sight window, resulting in oil leakage. 3. Connect muffler end of hose to foot control and inspect handpiece to ensure it is “iMRI” and that internal aspect of handpiece is free of damage or debris. Caution: Do not run handpiece without cutter and attachment installed. Damage to handpiece may result if handpiece is operated without cutter and attachment installed. 4. Select appropriate attachment. Inspect for any signs of corrosion or damage and ensure it is “iMRI.” Attach attachment to handpiece and turn clockwise to lock onto handpiece. Verify locking by pulling on attachment. 5. Select appropriate cutter and following all established sterile techniques, remove it from its packaging, insert it into and through attachment, into handpiece and lock into place. Verify locking by pulling on cutter. If using craniotome, cutter should be put into handpiece first, then put craniotome over cutter. 6. Attach iMRI foot control to air (or nitrogen) supply. Fully depress foot pedal and adjust supply air pressure such that gauge on foot control indicates 120 psi.

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7. With handpiece in iMRI field but away from patient, fully depress foot control and assess handpiece for noise, vibration, wobble, and whipping. If assembly was without difficulty and handpiece sounds and feels right, initiate or continue with use. 8. During procedure, continuously assess cutting effectiveness. Though iMRI cutters are designed to cut effectively, they are constructed of a much softer metal than standard (non-iMRI) Anspach cutters which you may be accustomed to. Because of material softness, iMRI cutters will dull more quickly. If you notice a reduction in cutting effectiveness, stop and replace cutter. Warnings: Do not reprocess or use reprocessed cutters. iMRI cutters are constructed of stainless steel that is subject to dulling and possible distortion during initial use. Reprocessors may not be able to reprocess cutters to their original design condition and reuse could result in excessive whipping or vibration that could cause severe patient injury including death. Reprocessed cutters may also be duller than new cutters, resulting in less effective use and possible overheating causing necrosis of tissues and/or surgeon discomfort. Continued use of dull cutters can cause user to apply greater pressure while cutting, which can seriously damage attachment, and possible bearing failure. Bearing failure can result in foreign debris entering surgical wound site. iMRI craniotome is constructed of a softer metal than a non-iMRI craniotome and excessively applied force will cause craniotome leg/foot to bend or fracture. Do not bend attachment or use craniotome as a lever. Do not force cutter. Forceful side load may cause cutter fracture, which could cause injury. It can also result in handpiece speed reduction and increased temperature. 9. During surgical procedure, when iMRI is used for actual imaging, remove iMRI System and Cutters from imaging volume.

Black Max Standard Attachments and Dissection Tool Assembly

Black Max Dissection Tool Identification All dissection tools are packaged sterile, unless otherwise indicated, and are manufactured for single use. Each dissection tool has a series of identification numbers and letters imprinted on the label and on the shaft. The first group of letters and numbers designate the part number, the second group of letters and numbers designate the lot number. Each attachment is laser-marked with its corresponding part number.

The first group of upper case letters of the dissection tool part number correspond to the attachment’s color-coded ring and/or name and the last digit represents the dissection tool style.

Black Max Straight Attachments Refer to “Components” section for part numbers. 1. Lift Lever on handpiece. Align notch on attachment with “RELEASE” on side of Black Max handpiece. Turn attachment so notch is aligned with word “SECURE.” 2. Insert dissection tool into attachment. Return Lever on Black Max handpiece to down position. 3. Pull dissection tool to ensure proper engagement. 4. Adjust air source until desired air pressure registers on AutoLube gauge. Note: Air pressure will not register until foot pedal is depressed.

B-SILVER

Handpiece is now fully functional. The Operating pressure is 120 psi (8.3 bar), as indicated on the AutoLube gauge, when using these attachments, except for those specified in “Assembly Procedures of AutoLube III” section.

For example: Black Max Dissection Tool Part Number: SIL-8 Dissection Tool Description: #8 style dissection tool used with the B-SILVER attachment.

B-TURQUOISE B-VIOLET B-BLUE-S B-MRA-S, B-MRA-M, B-MRA-L B-TURQ-L B-GREY-MIA16 B-GREY-MIA20 B-BLACK B-RED

Figure 1: Distal end of handpiece or attachment is pointed away Black Max Contra and Right Angle Attachments B-ORANGE-45 Contra Angle Attachment (Multiple Angle) B-ORANGE-90 Right Angle Attachment (90°) 1. Lift Lever on handpiece. Align notch on attachment with “RELEASE” on side of Black Max handpiece. Turn attachment so notch is aligned with word “SECURE.” 2. Push latch on the distal end of the attachment up with your thumb. 3. Insert dissection tool into the side of the distal end (opposite side of latch) while rotating slowly until dissection tool seats. 4. Release latch and check security of attachment by pulling it away from handpiece and check dissection tool by pulling on dissection tool head. Latch will be flush with attachment when dissection tool is secure.

B-ORANGE-90 B-ORANGE-45

Figure 2: Distal end of handpiece or attachment is pointed away

Handpiece is now fully functional. Synthes

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Black Max Standard Attachments and Dissection Tool Assembly

Black Max Craniotome and Specialty Attachments Refer to “Components” section for part numbers. 1. Lift Lever on Black Max. Insert dissection tool into handpiece. Return Lever to down position. Pull dissection tool to ensure proper engagement. 2. Slide attachment over dissection tool. Align notch on attachment with word “RELEASE” on the Black Max. Next turn attachment so notch is aligned with word “SECURE.” 3. The handpiece is now operational. Operating pressure is 120 psi (8.3 bar), as indicated on the AutoLube gauge, when using these attachments.

B-TURQ-X

B-GOLD

B-GREEN

B-GREEN-R

B-GREY-ADG

B-TURQ-CDA

Figure 3

Black Max QD Angle Attachments

B-QD8

Refer to “Components” section for part numbers.

1. Lift Lever on Black Max. Align notch on angle attachment with word “RELEASE” on the side of the Black Max. Next, turn angle attachment so notch is aligned with word “SECURE” which is laser etched on the side of the Black Max. 2. Pull down retaining sleeve on angle attachment and rotate to left when attachment is pointed away from you.

B-QD11

B-QD14

3. Insert dissection tool. 4. Release retaining sleeve by rotating to left. 5. Pull dissection tool to ensure proper engagement. 6. Return Lever on Black Max handpiece to down position. Handpiece is now fully functional. Operating pressure is 120 psi (8.3 bar), as indicated on the AutoLube gauge, when using these attachments.

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Figure 4

XMax and microMax Standard Attachments and Dissection Tool Assembly

Straight Attachment Assembly

Motor Housing/Handpiece (XMax, microMax)

Retaining Sleeve

Straight Attachment Dissection Tool

Craniotome Attachment Assembly

Motor Housing/Handpiece (XMax, microMax)

Retaining Sleeve

Dissection Tool

Craniotome Attachment

Dissection Tool Identification All dissection tools are packaged sterile, unless otherwise indicated, and are manufactured for single use. Each dissection tool has a series of identification numbers and letters imprinted on the label and on the shaft. The first letter describes the type of attachment, and the following characters indicate the size and style of the dissection tool. For example: Dissection Tool Part Number: S-2B Dissection Tool Description: 2 mm Fluted Ball for Short attachment Each attachment is laser-marked with its corresponding part number.

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XMax and microMax Standard Attachments and Dissection Tool Assembly

Straight Attachments SHORT MEDIUM LONG MIA16 SHORT-HD MEDIUM-HD LONG-HD XL-HD

5 cm Short Attachment 8 cm Medium Attachment 11 cm Long Attachment 16 cm Minimally Invasive Attachment 5 cm Heavy Duty Short Attachment 8 cm Heavy Duty Medium Attachment 12.4 cm Heavy Duty Long Attachment 20.2 cm Heavy Duty Extra Long Attachment

MM

SHORT MEDIUM LONG MIA16 SHORT-HD MEDIUM-HD

Assembly for handpieces with “SECURE” and “RELEASE” 1. Move handpiece knurled knob to “SECURE” position. 2. Slide attachment over distal end of handpiece housing, push down and rotate attachment to right approximately one quarter turn until fully seated. 3. Pull down on handpiece knurled knob and insert dissection tool into distal end of attachment. Rotate dissection tool slowly until dissection tool seats. 4. Release handpiece knurled knob to “SECURE” position. Handpiece is now fully functional. 5. Check security of dissection tool by pulling on dissection tool shaft. 6. Attachment and dissection tool are secure. Disassembly 1. Move handpiece knurled knob to “RELEASE” position. 2. Remove dissection tool from distal end of attachment. 3. Rotate attachment to left approximately one quarter turn and remove from distal end of handpiece.

LONG-HD XL-HD

XM Assembly for handpieces with and . (Distal end of handpiece or attachment is pointed away from user.) 1. Move handpiece knurled knob to “RUN” ( ) position. 2. Slide attachment over distal end of handpiece. Pull attachment towards handpiece, and rotate attachment to right approximately one quarter turn until fully seated. Handpiece knurled knob moves up to seat next to attachment. 3. Pull handpiece knurled knob towards “LOAD” ( ) position and insert dissection tool into distal end of attachment. Rotate dissection tool slowly until fully seated. 4. Release handpiece knurled knob into “RUN” ( ) position. Handpiece is now fully functional. 5. Pull dissection tool to ensure proper engagement. 6. Attachment and dissection tool are secure. Disassembly 1. Move handpiece knurled knob to “SAFE” position. 2. Remove dissection tool from distal end of attachment. 3. Rotate attachment to left approximately one quarter turn, and remove from distal end of handpiece.

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Orange 45° or 90° Contra Angle Attachments ORANGE-45 ORANGE-90

ORANGE-45

45° Contra Angle Attachment 90° Contra Angle Attachment

ORANGE-90

Set AutoLube operating pressure to 40 psi (2.8 bar).

MM Assembly for handpieces with and . 1. Ensure knurled knob on handpiece is in “RUN” ( ) position. 2. Slide attachment over distal end of handpiece. Push attachment towards handpiece, and rotate attachment clockwise until fully seated. Handpiece knurled knob moves up to seat next to attachment. 3. Push latch on the distal end of the attachment up with your thumb. 4. Insert dissection tool into the side of the distal end (opposite side of latch) while rotating slowly until dissection tool seats. 5. Release latch and check security of attachment by pulling it away from handpiece and check dissection tool by pulling on dissection tool head. Latch will be flush with attachment when dissection tool is secure. Handpiece is now fully functional. Disassembly 1. Lift latch on the distal end of the attachment with your thumb. Remove dissection tool and release latch. 2. Move handpiece knurled knob to “SAFE” position. 3. Rotate attachment counterclockwise and remove from distal end of handpiece.

XM Assembly for handpieces with

and . 1. Ensure knurled knob on handpiece is in “RUN” ( ) position. 2. Slide attachment over distal end of handpiece. Push attachment towards handpiece, and rotate attachment clockwise until fully seated. Handpiece knurled knob moves up to seat next to attachment. 3. Push latch on the distal end of the attachment up with your thumb. 4. Insert dissection tool into the side of the distal end (opposite side of latch) while rotating slowly until dissection tool seats. 5. Release latch and check security of attachment by pulling it away from handpiece and check dissection tool by pulling on dissection tool head. Latch will be flush with attachment when dissection tool is secure. Handpiece is now fully functional.

Disassembly 1. Lift latch on the distal end of the attachment with your thumb. Remove dissection tool and release latch. 2. Move handpiece knurled knob to “SAFE” position. 3. Rotate attachment counterclockwise and remove from distal end of handpiece.

Synthes

19