eMax Operating Manual Rev 4

Table of Contents Introduction ...1 Summary of Warnings and Cautions ...2 Definitions ...2 Warnings...2 Cautions ...2 Safety Standard(s) ...3 Latex-free Certification ...3 Warranty & Return Policies ...3 Glossary of Symbols...3 System Console ...4 Assembly Procedures ...4 Console Sound Indicators...5 Irrigation (optional) ...5 Irrigation Tubing Set-up ...5 Irrigation Attachment Clip Assembly ...6 Irrigation Pump Warnings ...6 eMax Operating Instructions ...7 The eMax Motor ...7 Operation ...7 Control of Motor Speed and Direction...7 Hand Control Assembly ...8 Foot Control Operation ...8 eMax Attachments and Cutting Burrs ...10 Cutting Burr Identification ...10 Directional Arrows ...10 Straight and Specialty Attachments/Cutting Burr Assembly and Disassembly ...10 Craniotome and Specialty Attachments/Cutting Burr Assembly and Disassembly ...10 QD Angle Attachments/Cutting Burr Assembly and Disassembly ...11

eMax Operating Manual

Table of Contents (continued from previous page) eMax Attachments and Cutting Burrs (continued) Micro Dissection Attachment/Cutting Burr Assembly and Disassembly ...11 microSaw System/Blade Assembly ...12 Chuck Driver System Assembly ...12 High Power e-Sagital Saw/Blade Assembly...12 SpeedReducer/SpeedReducer Adapter Assembly ...13 Powered Kerrison System (PKS)/Cutting Burr Assembly...13 Cleaning and Maintenance ...15 Motor ...15 Console and Foot Pedal ...15 Attachments...15 Cutting Burrs and Saw Blades ...15 Sterilization Trays ...15 Transport and Storage ...15 Sterilization ...16 Troubleshooting ...17 & 18 eMax Components and Specifications ...Inside Back Cover

eMax Operating Manual

Introduction

The eMax is an electrically powered high performance instrument system that operates at 80,000 rpm. It offers variable speed, bi-directional operation, minimal noise levels, and an optional hand control. It is a high performance drill that highlights minimal vibration performance, thermal energy management, and high reliability for Neurosurgeons, Neurotologists, Skull Base Surgeons, Spinal Surgeons, and Otolaryngologists. Before using the eMax system, 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

eMax Operating Manual

of this system, as improper use may cause injury. A certified Anspach Representative must train all surgeons operating the eMax. To schedule a class, please arrange a hands-on training course, either at Anspach Corporate Headquarters, or from your local Anspach Sales Representative, by calling +1-561-627-1080 (U.S./International) or +1-800-327-6887 (U.S. Toll Free). Should you have any questions after reading this manual, please call the Anspach Customer Service Department at +1-561-627-1080 (U.S./International) or +1-800-327-6887 (U.S. Toll Free).

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! Summary of Warnings and Cautions Definitions Warning - Identifies conditions and actions that pose hazards to the user or patient. Caution - Identifies conditions and actions that may damage the equipment under test.

! Warnings DO NOT modify ground or power cord. DO NOT operate in an explosive flammable environment. DO NOT use without inspecting the system for damage and the hose for any cuts or abrasions. Do not use if damage is evident. DO NOT allow liquid into the console, the console could be damaged. DO NOT operate this equipment unless you have been trained by a certified Anspach representative. The surgeon is responsible for learning proper techniques in the use of this equipment, as improper use may cause serious injury to user or patient or damage to the system. DO NOT cut where you cannot see unless an image intensifier is utilized. Delicate structures in proximity to the dissection must be thoroughly protected to prevent injury. DO NOT operate this instrument without the use of safety glasses. All operating room personnel must wear eye protection.

nism while the motor is running; doing so will make the safety mechanism inoperable. DO NOT operate without irrigation. Irrigation is mandatory for proper operation. DO NOT dispose of the cutting tools without using standard protocol for sharp instruments. DO NOT use a craniotome in conjunction with the Hand Control. Excessive rotational force on the hand control may move it, thus shutting the motor down. DO NOT use cutting burrs and saw blades more than once. Cutting burrs and Saw Blades are disposable and intended for single use only. DO enjoy using these instruments. We have manufactured them to conform to rigorous quality standards to provide dependable performance.

! Cautions United States Federal law restricts this device to sale by or on the order of a physician or other licensed health-care provider. Use care to protect the hose when handling, cleaning, and during system use. Damage to the hose can cause leaking, rupture, or other related failures. The power source should comply with the applicable IEC, CEC, and NEC requirements. Grounding reliability can only be achieved when this equipment is connected to a receptacle marked “HOSPITAL GRADE”

DO NOT bend the attachments or attempt to use attachment as a lever. Firm control of the instrument must be maintained at all times.

Continuous extreme cutting at near stalling conditions will quickly overheat the motor.

DO NOT force the cutting burrs while performing operation. Use a gentle tapping motion or side-to-side motion and let the instrument do the cutting. Forceful side loading of cutting burrs may cause fracture of dissecting tool, which may cause injury.

The Micro Dissection Attachment is to be used only for delicate bone dissection applications. Excessive force or side loads during use can cause rapid temperature increase at the distal end of the attachment. Always use copious irrigation with this attachment.

DO NOT operate the motor without an attachment and a cutting burr. Confirm the attachment is the proper size for the cutting burr and that it is secure. Cutting burrs must be adequately retained within the motor to prevent distal migration, which may cause injury.

The Anspach System Console automatically recognizes the installation of the microSaw attachments onto the handpiece and adjusts the speed to the appropriate level. The maximum allowable speeds are as follows:

DO NOT attempt to engage the safety mecha2

MS-OSC MS-SAG

15,000 cpm 15,000 cpm eMax Operating Manual

Operation of the microSaws at higher speed levels will cause damage to the attachments. When cleaning, do not immerse motor or attachments except as indicated in Anspach cleaning instructions, do not insert brush into motor housing, and do not use saline solution. Do not allow liquid to enter eMax console, foot pedal, or irrigation pump (console with optional irrigation).

Safety Standard(s) 1) UL 2601-1, Second Edition, Rev. 10/24/97: “Medical Electrical Equipment”: Part 1: General Requirements for Safety. 2) CSA-C22.2 No. 601.1-M90, including General Instruction No. 1: “Medical Electrical Equipment”: Part 1: General Requirements for Safety. 3) EN6061-1, Issue 2, October 1997, (incl. A1, A2, A11-13): “Medical Electrical Equipment: Part 1. General Requirements for safety.

Latex-free Certification There is no latex material in any of the Anspach products or packaging.

Warranty & Return Policies Two (2) years for parts and labor if maintained and operated in accordance with manufacturer's instructions. Cutting burrs and saw blades are supplied sterile and are disposable. To ensure the safe operation and high performance of the Anspach Instrument Systems, only Anspach manufactured components, cutting burrs, and saw blades should be used. Anspach reserves the right to invalidate the product warranty if the Anspach Instrument Systems are used with components not manufactured by Anspach or if repairs to the high-speed instrument system are not performed by Anspach.

Glossary of Symbols Attention (A.K.A. Caution, Warning, Danger, Important, Note, Refer to Accompanying Documentation) only

United States Federal law restricts this device to sale by or on the order of a physician or other licensed health-ccare provider. CE Mark (A.K.A. CE Mark [notified body number], Conformité Européenne) Meaning: Device complies with applicable EEC Directives Keep Dry (A.K.A. Protect from Moisture)

Lot (A.K.A. Lot Number, Batch Number, Batch Code) Reference Number (A.K.A. Item Number, Catalog number, Part Number) Single Use Only (A.K.A. Do Not Reuse) Sterile R (A.K.A. Sterilized Using Irradiation) Temperature Range (A.K.A. Ambient Temperature Range, Acceptable Ambient Temperature Range, Temperature Limitation) Meaning: Device storage and transport temperature range (ambient temperature). Use By Date (A.K.A. Expiration Date, Expiry)

All eMax System components returned for servicing or repair should be properly cleaned and sterilized as applicable prior to shipping.

eMax Operating Manual

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System Console Part No.: SC1000

The System Console houses the electrical components that provide power, control, and cooling functions to the eMax motor. It provides the user control for all system functions via an integral touch pad face panel. The System Console also provides interconnections for the eMax motor, two foot pedals, AC power inlet (90/240v) and the main power switch.

nector. Avoid pushing the connector into the connector port when out of alignment. 3. Plug the eMax motor connector into Motor 1 located on the connector panel. The eMax connector cord is keyed. Align the connector on the face panel with the eMax connector. Avoid pushing the connector into the connector port when out of alignment.

Assembly Procedures 1. The eMax high speed motor operates at 80,000 rpm. Plug the hospital grade AC power cord into the AC connector on the back of the console. Plug the opposite end of the power cord into a standard, Hospital Grade grounded wall outlet.

Power Switch Face Panel

Back of System Console

Foot Control Connectors AC Power Inlet

Power Switch

2. Insert the foot control cord into Foot Control 1. (A second foot control cord could be connected into Foot Control 2.) The foot control connector cord is keyed. Align the connector on the face panel with the foot control con-

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Motor Connector

4. Activate the console by depressing the power switch located on the back of the console to the "I" position. All appropriate Face Panel LEDs (Light Emitting Diodes) will illuminate, and a beep will sound.

eMax Operating Manual

Console Sound Indicators 1. 10 beeps immediately upon start up. Indicates motor is in “Safe” position or the cutter is not rotating. Console goes inactive for 10 seconds. 2. 5-ssecond continuous beep. Indicates motor is overheating. The motor housing will be extremely hot, and the console will shut the motor off for five minutes to allow the motor to cool. Caution: Continuous extreme cutting at near stalling conditions will quickly overheat the motor.

3. Insert IV pole into bracket on back of console. 4. Hang irrigtion bag onto IV Pole. 5. To activate, depress the "Irrigation" button on the face panel. LED will illuminate. 6. To control the flow of irrigation, depress the arrows located to the right of the irrigation button on the face panel. Irrigation (Activate and deactivate)

Increase Flow Decrease Flow

3. 8 beeps upon startup. Indicates reverse mode.

Irrigation (optional) Part No.: SC1000-II The eMax console is available with an optional peristaltic pump for irrigation. 1. Upon start-up Irrigation is OFF. LED is not illuminated. 2. Depress the button located on the back, upper left of the console labeled “Irrigation Pump Release” to release the pump head from the interior of the console. Back of SC1000-I Console

Irrigation Pump

eMax Operating Manual

LED: Irrigation

7. Irrigation can also be activated from the Foot Control (see Foot Control Operation). Simply depress the button on the top of the foot control. Upon activation LED on the face panel will illuminate. 8. The irrigation pump will be activated once the user steps on the foot pedal and activates the eMax.

Irrigation Tubing Set-up Part No.: IRRIGATE-TTUBE 1. Lift top of pump-head and insert large diameter tubing. Refer to diagram on irrigation pump housing to ensure tubing is routed properly. 2. Close lid on pump-head. 3. Insert bayonet end of tubing into irrigation bag.

Irrigation Pump Release Button

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Irrigation Attachment Clip Assembly Part Nos.: IRR-C CLIP-1 10 (SHORT), IRR-C CLIP-2 20 CLIP-3 30 (SHORT-HD), IRR-C CLIP-4 40 (QD8), IRR-C CLIP-5 50 (MEDIUM, LONG), (MEDIUM-HD), IRR-C IRR-C CLIP-6 60 (QD11, QD14), IRR-C CLIP-7 70 (MIA16) 1. Slide irrigation tubing (IRRIGATE-TUBE) onto proximal end of Irrigation Attachment Clip. 2. Attach Irrigation Attachment Clip to Anspach Motor System.

Irrigation Pump Warnings Do not modify ground or power cord. Do not operate in an explosive flammable environment. Inspect system for damage before using; do not use if damage is apparent. Do not allow liquid into pump. Do not operate this equipment unless trained by a certified Anspach representative. 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. Disposable tubing, Attachment Clip, and Hose Clip are for SINGLE USE ONLY.

3. Secure tubing to motor hose using Hose Clips, which are included with IRRIGATE-TUBE.

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eMax Operating Manual

eMax Operating Instructions Part No.: EMAX

The eMax Motor

direction depress the "R" or "F" arrow located on the face panel or foot pedal. LED: Forward

F: Forward Attachment Connection Knurled Knob

R: Reverse Motor Hose Motor Housing

LED: Reverse

Direction can only be changed when the motor is not running. A series of eight beeps will be heard when the motor starts to rotate in reverse.

Operation Firm control of the eMax must be maintained at all times. Never force the cutting burr. Let the instrument do the cutting. Only Anspach microMax/eMax cutting burrs should be used with the eMax. Always use continuous irrigation to prevent heat build-up. Never use the attachments as a retractor to bend or pry. Always wear safety glasses.

Control of Motor Speed and Direction 1. Upon start-up, the eMax motor is set at full speed. The display reads 80,000 ± 10% RPM. To increase or decrease the speed of the motor, depress the blue arrows located on the face panel. Speed increases and decreases in 10,000-RPM increments.

3. Rotational direction can also be changed by depressing the toggle switch located on the top left of the foot control for one second; the console will beep once to let the user know the motor has switched direction. To switch back to forward mode, quickly depress the toggle switch for one second. It will instantly switch back into the forward mode, and one beep will sound. When the direction changes the LED on the face panel located to the left of the “F” will indicate the forward direction. The LED located to the left of the “R” will indicate reverse direction.

Depressing this control changes the direction

Increase Speed

Decrease Speed

2. Upon start-up the eMax motor is set to rotate in the forward/clockwise direction. To change

eMax Operating Manual

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Hand Control Assembly Part No.: EMAX-H HC

7. To deactivate the Hand Control, select the "Foot Control" button on the face panel. Remove the hand control from the motor housing by applying pressure to the clamps, pushing from the front, and sliding back toward the hose. Use care in removing the Hand Control so that the hose is not damaged.

1. The optional hand-control attachment for the eMax motor allows the user to control the operation of the motor with a lever that is attached to the eMax handpiece.

Warning: It is recommended that a craniotome is not used in conjunction with the Hand Control. Excessive rotational force on the hand control may move it, thus shutting the motor down.

2. Upon start-up the Hand Control is OFF. LED is not illuminated.

Foot Control Operation

Run

Safe

3. Before attempting to use the Hand Control, check that the Safety Switch on the top of the Hand Control is positioned at "Safe," preventing the Hand Control from operating. 4. Rotate motor until the small circular dimple at the back end of the motor faces up. Slide hand control over the hose end of the motor such that the ears on the hand control slide into the grooves at the hose end of the motor. Press the hand control onto the motor until secure. 5. To activate the Hand Control, depress "Hand Control" button on the console front panel. This will deactivate the Foot Control and illuminate the Hand Control LED on the face panel. Hand Control

Part No.: EMAX-FFP 1. The SC1000 and the SC1000-I have the option for using two foot controls. Notice the connector panel has two connector ports marked Foot Control 1 and Foot Control 2. 2. The LED's on the face panel correspond to the connector ports on the connector panel. Depressing the “Foot Control” button on the face panel will alternatively activate Foot Pedal 1, then Foot Pedal 2. Only one foot pedal can be active, and direction can only be changed when the motor is not running. Warning: Motor is fully functional at this time. Foot Control LED: Foot Control #1 LED: Foot Control #2

LED

6. Move the Safety Switch from the "Safe" position to the "Run" position. Applying pressure on the handle of the Hand Control operates the motor. Warning: Motor is fully functional at this time. 8

3. If two (2) foot controls are plugged in upon start-up, the console will default to Foot Control #1 4. If using the SC1000-I System Console, irrigation can be activated from the Foot Control. Simply depress the toggle switch on the right side of the foot control and then step on the foot pedal, located in the center, to activate eMax Operating Manual

the eMax. Upon activation, the LED on the System Console face panel will illuminate, and the irrigation pump and the motor are started. 5. The rotational direction of the motor can also be changed by depressing the toggle switch located on the top left of the foot pedal for one second. When the direction is changed, a single beep will sound, and the LED on the System Console face panel will signify the direction of rotation. Direction can only be changed when the motor is not running.

eMax Operating Manual

Directional Toggle Switch

Irrigation Control

Foot Pedal

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eMax Attachments and Cutting Burrs Cutting Burr Identification All cutting burrs are packaged sterile, unless otherwise indicated, and are manufactured for single use. Each cutting burr 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 cutting burr. An Example follows: eMax Cutting Burr Part Number: S-2B Cutting Burr Description: 2mm Fluted Ball for Short attachment Each attachment is laser marked with its corresponding part number.

Directional Arrows Notice the directional arrow and printing on the side of the motor housing at the distal end: “SECURE” and “RELEASE.” These terms refer to locking and unlocking the attachment and cutting burr onto the motor.

Straight Attachments/Cutting Burr Assembly and Disassembly See inside back cover for a complete list of part numbers. 1. Move the motor handpiece knurled knob to the “SECURE” position. 2. Slide the attachment over the distal end of the motor housing. Push down, and rotate the attachment to the right approximately one quarter turn until fully seated.

SHORT

SHORT-HD MEDIUM MEDIUM-HD LONG

3. Pull down on the MIA 16 motor handpiece knurled knob and insert cutting burr into the distal end of the attachment. Rotate the cutting burr slowly until it is fully seated. 4. Release the motor handpiece knurled knob into the “SECURE” position. 5. Check the security of the cutting burr by pulling on the cutting burr head. 6. Attachment and cutting burr are now secure.

Disassembly SECURE

Knurled Knob

RELEASE

Directional Arrow

Directional Arrow

Fully Assembled Cutting Burr and Straight Attachment

1. Move the motor handpiece knurled knob to the “RELEASE” position. 2. Remove the cutting burr from the distal end of the attachment. 3. Rotate the attachment to the left approximately one quarter turn, and pull off the distal end of the motor housing.

Craniotome and Specialty Attachments/Cutting Burr Assembly and Disassembly Part Nos.: CRANI-P P, CRANI-A A, CRANI-LL, CRANI-A A-R R, ADG, CDA 1. Pull down on the motor handpiece knurled knob and insert cutting burr into the distal end

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CRANI-P

CRANI-A CRANI-L

eMax Operating Manual

of the motor housing. Rotate the cutting burr slowly until the cutting burr is fully seated.

CRANI-A-R

2. Release the motor handpiece knurled knob into the “SECURE” position.

5. Release retaining sleeve on the angle attachment by rotating the retaining sleeve to the right.

ADG

6. Check the security of the cutting burr by pulling on the cutting burr head.

CDA

Disassembly

3. Check the security of the cutting burr by pulling on the cutting burr head. 4. Slide the attachment over the cutting burr and distal end of motor housing. Push down, and rotate the attachment to the right approximately one quarter turn until fully seated. 5. Attachment and cutting burr are now secure.

Disassembly 1. Move the motor handpiece knurled knob to the “RELEASE” position.

1. Pull down on the retaining sleeve on the angle attachment and rotate to the left. 2. Remove the cutting burr from the distal end of the attachment. 3. Move the motor handpiece knurled knob to the “RELEASE” position. 4. Rotate the attachment to the left approximately one quarter turn, and pull off the distal end of the motor housing.

2. Rotate the attachment to the left approximately one quarter turn and pull off the distal end of the motor housing.

Micro Dissection Attachment/ Cutting Burrs Assembly and Disassembly

3. Remove the cutting burr from the distal end of the motor housing.

Part No.: MDA

QD Angle Attachments/Cutting Burr Assembly and Disassembly

1. Hold MDA by the drive shaft. Insert the cutting burr into the MDA attachment until the cutter “seats” in the attachment. (Drops slightly proximally and stops rotating.) This is best accomplished by pushing slightly while rotating.

See inside back cover for a complete list of part numbers. 1. Pull down on the motor handpiece knurled knob and slide the angle attachment over the distal end of the motor housing until fully seated. Rotate the attachment to the right approximately one quarter turn.

2. Check security of cutting burr by pulling distally. QD8

QD11

QD14

2. Release the motor handpiece knurled knob to the “SECURE” position. 3. Pull down the retaining sleeve on the angle attachment and rotate to the left. 4. Insert the cutting burr into the angle attachment. Rotate the cutting burr slowly until it is fully seated. eMax Operating Manual

3. Pull down on the motor handpiece knurled knob and slide the MDA Attachment over the distal end of the motor handpiece until fully seated. Rotate the attachment to the right approximately one quarter turn. 4. Release the motor handpiece knurled knob to the “SECURE” position.

Caution: The Micro Dissection Attachment is to be used only for delicate bone dissection applications. Excessive force or side loads during use can cause rapid temperature increase at the distal end of the attachment. Always use copious irrigation with this attachment.

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Disassembly 1. Move the motor handpiece knurled knob to the “RELEASE” position. 2. Slowly rotate the cutting burr in alternating directions while pulling distally. 3. Rotate the attachment to the left approximately one quarter turn and pull of the distal end of the motor housing.

microSaw System/Blade Assembly Part Nos.: MS-O OSC, MS-SSAG 1. Move the eMax motor handpiece knurled knob to the “SECURE” position. 2. Align the microSaw shaft into the motor handpiece, and slide the microSaw attachment onto the motor handpiece. 3. Rotate the microSaw attachment to the right to secure. The attachment will move distally a slight amount as it locks into position. 4. Check the security of the attachment by pulling distally. 5. For Removal, pull the microSaw attachment proximally while rotating to the left. Note: the microSaws do not operate if the Hand Control is activated.

microSaw Blade Assembly 1. Press down on the release button to open the saw blade mounting plates. Release Button MS-OSC

Release Button

Note: Saw blades used must be Anspach blades. Warning: All microSaw blades are for single use only. Caution: The Anspach System Console automatically recognizes the installation of the microSaw attachments onto the handpiece and adjusts the speed to the appropriate level. The maximum allowable speeds are as follows: MS-O OSC MS-SSAG

15,000 cpm 15,000 cpm

Operation of the microSaws at higher speed levels will cause damage to the attachments.

Chuck Driver System Assembly Part No.: C-SSYSTEM 1. Move the motor handpiece knurled knob to the “SECURE” position. 2. Align the Chuck Driver System shaft into the motor handpiece and slide the attachment onto the motor handpiece. 3. Rotate the Chuck Driver System attachment to the right until it stops. The attachment will move distally slightly as it locks into position. 4. Check the security of the attachment by pulling distally. 5. For Removal, move the Chuck Driver System attachment slightly proximally while rotating to the left.

High Power e-Sagittal Saw/Blade Assembly MS-SAG

2. Insert the saw blade into the opening and align the saw blade hub with the locking pins in the mounting plates. The oscillating saw blades can be aligned in 45° increments. 12

3. Release the button and ensure that the mounting plates are firmly seated on the saw blade without any gaps.

Part No.: E-SSAGITTAL 1. Connect the HP e-Sagittal Saw control cable to the eMax Operating Manual

proximal end of the saw attachment. Align the connectors, and insert the plug fully until secure. 2. Connect the other end of the control cable to the Anspach System Console in the panel connector marked Motor 1. Align the connector on the face panel with the connector on the control cable, and insert the plug fully until secure. Note: the Foot Pedal must be connected to the System Console. See section “Foot Control Operation” of this manual.

Saw Blade Assembly 1. Raise and fully extend the extension handle on the saw blade attachment mechanism. 2. Rotate the extension handle counter-clockwise to open the saw blade mounting plates. 3. Insert the saw blade into the opening and align the saw hub with the locking pins in the mounting plates. The blades can be aligned in 45° increments. 4. Rotate the extension handle clockwise to secure the saw blade and lower the handle into its closed position. Note: Saw blades used must be Anspach blades. Warning: All microSaw blades are for single use only.

of 100 to 1, and the B-SPEED-REDUCER/77 provides a gear reduction of 77.5 to 1. The SpeedReducer has a Hudson end for use with compatible perforators. 1. Move the motor handpiece knurled knob to the “RELEASE” position. 2. Slide the SpeedReducer Adapter over the distal end of the motor housing until fully seated. Rotate the attachment to the right approximately one-quarter turn. 3. Move the motor handpiece knurled knob to the “SECURE” position. 4. Insert the SpeedReducer Adapter into the SpeedReducer. Rotate the SpeedReducer to the right approximately one-quarter turn. 5. Pull back on the SpeedReducer's knurled retaining sleeve. 6. Insert Hudson-end of cranial perforator and release retaining sleeve.

Powered Kerrison System (PKS)/Cutting Burr Assembly and Disassembly Part Nos.: PKS-1 100HP, PKS-3 320BG, PKS-3 390BG, PKS-5 520BG, PKS-5 590BG, PKS-3 300MM

SpeedReducer/SpeedReducer Adapter Assembly Part Nos.: SR-A ADAPTER, B-SSPEED-R REDUCER, B-SSPEED-R REDUCER/77

SR-ADAPTER

1. Move the motor handpiece knurled knob to the “RELEASE” position. 2. Slide eMax Motor Attachment over distal end of motor until fully seated. Rotate eMax Motor Attachment counterclockwise. 3. Fully insert cutting burr through the attachment. Rotate knurled knob counterclockwise to the “SECURE” position.

B-SPEED-REDUCER

The Speed-Reducer Adapter allows for the connection of the B-SPEED-REDUCER and the BSPEED-REDUCER/77 to the eMax motor. The BSPEED-REDUCER provides a gear reduction ratio eMax Operating Manual

4. Pull cutting burr to ensure engagement. 5. Insert above assembly into large diameter opening on handle attachment until fully seated. Squeeze trigger, then pull motor to ensure proper engagement. 13

6. slide burr guard attachment over distal end of handle attachment, then rotate counterclockwise to secure.

2. Remove burr guard by pulling back on button located on the front of the handle attachment and rotating the burr guard clockwise.

7. Squeeze trigger to expose cutting burr; trigger will require a pecking style.

Cleaning Instructions

8. Motor is operational.

Disassembly 1. Remove motor by pulling down on lever located underneath the rear portion of handle attachment while pulling motor proximally.

Universal Front Burr Guard Attachments

Clean PKS Handle and Burr Guards with ultrasonic cleaning equipment then follow with a surgical instrument lubrication. Caution: Refer to the Cleaning and Maintenance Section of this manual for the eMax Motor Attachment (Do not immerse).

Universal Handle Attachment

3mm PKS 20 Degree Burr Guard Attachment (PKS-320BG)

eMax Motor Attachment and Cutting Burrs

eMax Motor Attachment (PKS-300MM)

3mm PKS Twist Barrel Cutter (PKS-3BA) for use only with the 3mm Burr Guard Attachments

3mm PKS 90 Degree Burr Guard Attachment (PKS-390BG)

Universal Handle Attachment (PKS-100HP)

5mm PKS 20 Degree Burr Guard Attachment (PKS-520BG)

5mm PKS Twist arrel Cutter (PKS-5BA) for use only with the 5mm Burr Guard Attachments

5mm PKS 90 Degree Burr Guard Attachment (PKS-590BG)

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eMax Operating Manual

Cleaning and Maintenance Motor DO NOT IMMERSE! Prior to sterilization, wipe with a clean, waterdampened cloth and mild detergent or isopropyl alcohol. Silicone Spray or Instrument Milk may be added to lubricate the motor handpiece knurled knob. Silicone spray may be used on the hose to prolong its flexibility and to facilitate foreign particle removal. The motor handpiece should be tested by running it with an attachment and cutting burr at least every three months for one minute to determine the temperature. If the distal tip and main body of the handpiece are uncomfortably hot to the touch (approximately 43°C [110°F]), return the instrument to Anspach for servicing. Do not insert brush into motor housing. Do not use saline solution for cleaning.

Console and Foot Pedal DO NOT STERILIZE!

2. Immerse attachment in a clean container filled with an adequate amount of isopropyl alcohol to fully cover the attachment. 3. Agitate for 30 seconds. 4. Remove the attachment from the container and wipe with a lint free cloth wetted with isopropyl alcohol. 5. Gently insert and remove Anspach Attachment Cleaning Brush (ACB) wetted with isopropyl alcohol thru the distal (tip) opening of the attachment as many times as necessary to remove any foreign debris. DO NOT FORCE the brush into or through the attachment. 6. Remove the brush. 7. Rinse the attachment in a clean container of isopropyl alcohol while agitating for 30 seconds. 8. Dry attachment on a clean, lint free cloth.

Cutting Burrs and Saw Blades Disposable. Single use only.

1. Disconnect all power from console.

Sterilization Trays

2. Clean console, and foot pedal, and irrigation pump (on the console with optional irrigation) by wiping with non-abrasive cloth and disinfectant or mild detergent and water.

Sterilization trays can be cleaned with water and a mild detergent.

Caution: DO NOT allow liquid to enter console, foot pedal, or irrigation pump (console with optional irrigation). 3. Dry thoroughly with non-abrasive cloth.

Attachments DO NOT IMMERSE! Except as specified below. Note: isopropyl alcohol may be substituted for Viraguard® in the following procedure.

Transport and Storage The recommended environmental conditions for transport and storage are: 1) Temperature: -40°C to + 70°C (-40°F to +158°F) 2) Relative Humidity: 10% to 100% 3) Atmospheric Pressure: No requirements Caution: Unit must not be exposed to ingress of water or to severe physical trauma; degradation of unit function and/or performance may occur.

1. Remove the attachment and cutting burr from the motor handpiece.

eMax Operating Manual

15

Sterilization Motor and Attachments Metal devices, tools and equipment are constructed of materials unaffected by normal environmental conditions of current standard sterilization means, when proper operational techniques are employed. Effectiveness of sterilization equipment or sterilization processes are directly dependent upon numerous factors beyond the Company’s control including among other things; sterilization means, processes and wrapping techniques employed, brand, model and condition of sterilization equipment, care and maintenance techniques employed and operator knowledge and experience. Before sterilizing: Place attached protective cap over electrical connector on eMax motor prior to sterilization. Ensure sterilization equipment is in proper working order as specified by the manufacturer. Assure equipment manufacturer’s instructions are properly employed by trained and qualified personnel; Assure actual cycle employed has been properly validated for the device(s)/load configuration being processed

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and appropriate sterilization indicator devices are included for each process and cycle. The Company cannot anticipate all possible equipment, processes and/or conditions that may be encountered. The suggested operation conditions are to be considered as a starting point for determination of the overall process capability, without regard for type or condition of equipment used or methods, techniques or practices employed by the user. Use of proper sterilization indicator devices is strongly recommended. Recommended Sterilization Exposure Times 1. Steam Autoclave/Gravity Air Displacement 132°C ± 1°C (270°F ± 2°F) 20 minutes unwrapped 2. Steam Autoclave/Pre-vacuum 132°C ± 1°C (270°F ± 2°F) 10 minutes wrapped or 4 minutes unwrapped 3. STERRAD 100S Full Cycle

eMax Operating Manual

Troubleshooting Problem

Possible Cause

Solution

Lack of power or excessive motor noise

Defective internal component

Return to Anspach for service

Lack of Power

Plug is not fully inserted/power switch not turned on

Verify that the plug to the wall and to the back of the console are pushed all the way in and the power switch is in the “I” position

Outlet is not functional

Verify that another piece of electrical equipment can receive power from the outlet

Defective internal component

Return to Anspach for service

Internal motor is overheating due to continuous extreme cutting at near stalling conditions (five-second continuous beeps are heard)

Console will shut the motor off for five minutes (safety). If it continues to shut off during normal cutting, return to Anspach for service.

Motor out of balance

Return to Anspach for service

Motor hose damaged

Return to Anspach for service

Cutting burr may be bent

Replace with new eMax cutting burr

Cutting burr may not be fully seated

Reassemble cutting burr and attachment

Improper attachment and cutting burr combination

Only use the correct cutting burr with appropriate attachment

Possible attachment bearing damage

Return attachment to Anspach for service

Hose may be kinked

Unkink hose (verify that it is not being pinched or clamped to the table)

Debris lodged inside attachment

Clean attachment using Midwest cleaning lubricant along with Anspach NOZZLE and only an Anspach Attachment Cleaning Brush (ACB) to remove debris

Possible bearing damage

Return attachment to Anspach for service

Excessive force used in operation

Do Not Use, replace attachment

Motor vibration or extremely hot

Excessive vibration of cutting burr

Attachment is hot

Craniotome attachment is bent

eMax Operating Manual

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