DePuy Synthes

Anspach EG1 Product Guide Oct 2014

Product Guide

42 Pages

Table of Contents Introduction DePuy Synthes Power Tools 2 Anspach EG1 High Speed Electric System 2 Indications2 Warnings 3 Cautions4 Technical Specifications 5 Glossary of Symbols 10 Assembly and Operating Instructions EG1 High Speed Electric System 12 Attachments and Dissection Tools Dissection Tool Identification 18 Straight Attachments 19 Craniotome Attachments 20 QD Angle Attachments 21 Minimal Access Attachment and Bearing Sleeves 22 Perforator Driver Attachment 24 Inspection and Maintenance Manual Cleaning 25 28 Mechanical/Automated Cleaning 31 Sterilization 34 Care and Maintenance Troubleshooting36 EG1 Console Alerts, Codes, and Displays 38 Ordering Information 40 Anspach EG1 Electric System Product Guide DePuy Synthes Power Tools

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Anspach EG1 High Speed Electric System Precision and Power

Product Guide

Table of Contents

Introduction

DePuy Synthes Power Tools

Anspach EG1 High Speed Electric System

Indications2 Warnings

Cautions4 Technical Specifications

Glossary of Symbols

Assembly and Operating Instructions

EG1 High Speed Electric System

Attachments and Dissection Tools

Dissection Tool Identification

Straight Attachments

Craniotome Attachments

QD Angle Attachments

Minimal Access Attachment and Bearing Sleeves

Perforator Driver Attachment

Inspection and Maintenance Manual Cleaning

25 28

Mechanical/Automated Cleaning

Sterilization

Care and Maintenance

Troubleshooting36 EG1 Console Alerts, Codes, and Displays

Ordering Information

Anspach EG1 Electric System

Product Guide

DePuy Synthes Power Tools

Anspach EG1 High Speed Electric System Precision and Power

DePuy Synthes Power Tools DePuy Synthes Power Tools manufactures pneumatic and electric high speed performance instruments and attachments to meet the specific needs of both surgeon and staff. While the advanced design of these instruments provides performance and reliability for the most demanding applications, they also allow for effortless assembly. All DePuy Synthes Power Tools instruments are manufactured to conform to rigorous quality standards to provide dependable performance.

Spine surgery

Anspach EG1 High Speed Electric System The EG1A Handpiece operates up to 80,000 rpm. It offers variable speed, bidirectional operation and minimal sound levels. It is a high performance system and highlights minimal vibration performance, thermal energy management, and high reliability for neurosurgeons, neurotologists, skull base surgeons, spinal surgeons, and otologists. Warning: Before using any of the Anspach High Speed Electric Systems, it is imperative that all individuals working with the system read the accompanying documentation with the product. 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, contact your local DePuy Synthes Power Tools sales representative, or call (800) 327-6887 or (561) 627-1080 to schedule a course. If you have any questions after reading this guide, please call your local DePuy Synthes Power Tools sales representative or the DePuy Synthes Power Tools Customer Service Department at (800) 327-6887 or (561) 627-1080.

Indications The Anspach EG1 High Speed Electric System is intended for cutting and shaping bone including the spine and cranium. The Anspach EG1 High Speed Electric System is composed of handpiece model eG1a; electric console models SC3001 and SC3002; foot control models E-FP, E-FP-DIR, and E-FP-DIR/IRR; associated attachments and dissection tools.

DePuy Synthes Power Tools

Anspach EG1 Electric System

Neurosurgery, otology, and neurotology

Product Guide

Warnings and Cautions

Warnings •

Always use continuous irrigation to prevent heat build-up. Irrigation is necessary for proper performance.

• 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

• Continuous extreme cutting at or near stalling conditions will quickly overheat handpiece.

• Do not operate in an explosive flammable environment. • Do not modify ground or power cord. • Do not allow liquid into console. • Use of accessories or cables other than those provided by DePuy Synthes Power Tools and specified for use with EG1 System may result in increased emissions or decreased immunity.

• The EG1 should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the EG1 should be observed to verify normal operation in the configuration in which it will be used. Do not stack equipment which is heavier than 13.6 kg (30 lbs).

• Medical electrical equipment needs special precautions regarding Electromagnetic Compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in this accompanying documentation.

• Portable and mobile RF communications equipment can affect medical electrical equipment.

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.

• Power source should comply with 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 use in oxygen rich environment. • No modification of this equipment is allowed.

• Only cut visible areas unless an image intensifier is utilized. • Delicate structures in proximity to dissection must be thoroughly protected to prevent injury.

• Do not modify. Modifications could result in loss of electrical safety.

• Dispose of items contaminated with body fluids with other biohazardous waste.

• Maintain firm control of instrument at all times.

• At end of life recycle or dispose of device in accordance

• Do not bend or use as a lever. • Use a gentle tapping motion or side-to-side motion and

with local and national regulations.

• To avoid the risk of electric shock, this equipment must

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.

only be connected to a supply main with protective earth. The use of accessories, transducers, and cables other than those specified, with the exception of transducers and cables sold by the manufacturer of this device as replacement parts for internal components, may result in increased emissions or decreased immunity of the EG1 System.

• Use standard protocol for disposal of sharp instruments. Anspach EG1 Electric System

Product Guide

DePuy Synthes Power Tools

Warnings and Cautions

Cautions x United States federal law restricts this device to sale by or on order of a physician or other licensed healthcare provider.

x Do not use accessories other than those provided by DePuy Synthes Power Tools and specified for use with Anspach Systems.

x To insure equipment operates as designed, read, and follow manufacturer’s instructions.

x Do not operate handpiece without an attachment and the

x Only Anspach G1 Dissection Tools should be used with G1 Systems.

x Use care to protect hose when handling, cleaning, and during system use.

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

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

corresponding dissection tool.

DePuy Synthes Power Tools

Anspach EG1 Electric System

Product Guide

Technical Specifications

EG1a Handpiece Specifications

Foot Pedal (E-FP, E-FP-DIR, E-FP-DIR/IRR) Specifications

Speed: 10,000 –80,000 rpm Handpiece/hose Length: 3.8 m (12.5 ft) Outside Housing (diameter): 19.1 mm (0.8 in) Length of Housing: 127.76 mm (5.03 in) Handpiece Weight: 116.0 g (4.1 oz) Handpiece/hose Weight: 488.7 g (17.2 oz)

Size:

26.7 cm x 16.5 cm x 14.7 cm (10.5 in x 6.5 in x 8.5 in) Weight: 2.0 kg (4.4 lbs) Cord: 3.7 m (12 ft) in length Fluid Ingress Protection: IPX8

Environmental Conditions Console (SC3001 and SC3002) Specifications Electrical: Primary: 100-240VAC, 50 / 60 Hz, 250 VA Class I: Protective Earth Fluid Ingress Protection: IPX0 Type B: Applied Part Continuous Operation

Mechanical: SC3001 SC3002 Height, mm (in) 131.6 (5.2) 131.6 (5.2) Width, mm (in) 304.3 (12.0) 342.7 (13.5) Length, mm (in) 299.8 (11.8) 304.8 (12) Weight, kg (lbs) 3.7 (8.2) 4.7 (10.4) The device complies with the following standards: IEC 60601-1:2005: + CORR. 1 (2006) + CORR. 2 (2007), EN 60601-1:2006 +A11:2011, ANSI/AAMI ES60601-1:2005, CAN/ CSA-C22.2 No.60601-1:08, (3rd edition) Medical electrical part 1: General requirements for basic safety and essential performance; UL 60601-1:2003 (Revised 2006), IEC 6011:1988 +A1:1991 + A2:1995; EN60601-1:1990 with A1 and A12:1993, A2:1995 and A13:1996; and CAN/CSA C22.2 No. 601.1-M90, Standard for Medical Electrical Equipment – Part 1 General Requirements for Safety With regard to electrical shock, fire, mechanical hazards, this ETL classified device conforms to AAMI STD ES606011, UL STD 60601-1, and is certified to CSA STD C22.2 No.60601-1 and 601.1

Temperature Operating: Transportation and Storage:

18°–30°C (65°–85°F) -29° – +50°C (-20° - +120°F)

Relative Humidity Operating: Transportation and Storage:

30% to 70% 10% to 90%

Atmospheric Pressure Operating: 0.7–1.06 bar Transportation and Storage: Not applicable Patent Information For patent information about this product, go to: www.depuy.com/patentmarking Not made with natural rubber latex Note: If a fuse replacement is necessary, use only a Time Lag, 5 x 20 mm, 5A, 250V fuse. Caution: For continued protection against risk of fire and electric shock, replace fuse only as marked. Note: x Item to be replaced by DePuy Synthes Power Tools repair facility ONLY. x Return all equipment to DePuy Synthes Power Tools for proper disposal.

This device complies with applicable EEC directives. Medical Device Directive 93/42/EEC as amended by 2007/47/EC. Machinery Directive 2006/46/EC.

Anspach EG1 Electric System

Product Guide

DePuy Synthes Power Tools

Technical Specifications

Guidance and manufacturer’s declaration – electromagnetic emissions The EG1 System is intended for use in the electromagnetic environment specified below. The customer or the user of the EG1 System should ensure that it is used in such an environment. Emission test

Compliance

Electromagnetic environment – guidance

RF emissions

Group 1

The EG1 System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

Class A

The EG1 System is suitable for use in all establishments, other than domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

CISPR 11 RF emissions CISPR 11 Harmonic emissions

Class A

IEC 61000-3-2 Voltage fluctuations/ flicker emissions

Complies

IEC 61000-3-3

DePuy Synthes Power Tools

Anspach EG1 Electric System

Product Guide

Technical Specifications

Guidance and manufacturer’s declaration-electromagnetic immunity The EG1 System is intended for use in the electromagnetic environment specified below. The customer or the user of EG1 System should assure that it is used in such an environment. Immunity test standard

IEC 60601 test level

Compliance level

Electromagnetic environment- guidance

Electrostatic discharge (ESD) IEC 61000-4-2

±6 kV contact

±8 kV air

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%

Electrical fast transient / burst

±2 kV for power supply lines ±1 kV for input/output lines

Mains power quality should be that of a typical commercial or hospital environment.

IEC 61000-4-4

±2 kV for power supply lines ±1 kV for input/output lines

Surge

±1 kV line(s) to line(s)

Mains power quality should be that of a typical commercial or hospital environment.

IEC 61000-4-5

±2 kV line(s) to earth

Voltage dips, short interruptions and voltage variations on power supply input lines

<5% UT (>95% dip in UT) for 0,5 cycle

40% UT (60% dip in UT) for 5 cycles

70% UT (30% dip in UT) for 25 cycles

<5 % UT (>95 % dip in UT) for 5 sec

3 A/m

IEC 61000-4-11

Power frequency (50 / 60 Hz) magnetic field

Mains power quality should be that of a typical commercial or hospital environment. If the user of the EG1 System requires continued operation during power mains interruptions, it is recommended that the EG1 System be powered from an uninterruptible power supply or a battery.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

IEC 61000-4-8 Note: UT is the AC mains voltage prior to application of the test level.

Anspach EG1 Electric System

Product Guide

DePuy Synthes Power Tools

Technical Specifications

Guidance and manufacturer’s declaration – electromagnetic immunity The EG1 System is intended for use in the electromagnetic environment specified below. The customer or the user of the EG1 System should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment– guidance Portable and mobile RF communications equipment should be used no closer to any part of the EG1 System, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1.2

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3 Vrms

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

3 V/m

d = 1.2

80 MHz to 800 MHz

d = 2.3

800 MHz to 2.5 GHz

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, ashould be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the eG1 System is used exceeds the applicable RF compliance level above, the eG1 System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the eG1 System. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

DePuy Synthes Power Tools

Anspach EG1 Electric System

Product Guide

Technical Specifications

Recommended separation distances between portable and mobile RF communications equipment and the EG1 System The EG1 System is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the EG1 System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the EG1 System as recommended below, according to the maximum output power of the communication equipment. Rated maximum output power of transmitter

Separation distance according to frequency of transmitter (m) 150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

d = 1.2

d = 2.3

0.01

.12

.23

0.1

.38

.73

1.2

2.3

3.8

7.3

100

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Anspach EG1 Electric System

Product Guide

DePuy Synthes Power Tools

SAFE

Glossary of Symbols CUTTER RUN ADJUST

SAFE

TUBE

SAFE

CUTTER RUN CUTTER ADJUST RUN TUBE ADJUST TUBE

SAFE SAFE SAFE Anspach Product Icon

Indicates the attachment setting, refer to MA-D20-G1 section in this document for RUN further details ADJUST TUBE

CUTTER CUTTER RUN CUTTER RUN ADJUST ADJUST TUBE TUBE

2.4

Located on the Console;1.6 this indicates Reverse (Counterclockwise rotation when looking at 0.5 handpiece from proximal end)

F F R Indicates position, alignment or location R (Color: black or red)

3.2

4.8

United States8.0 6.4Federal law restricts this device to sale by or on the order of a physician or other licensed health-care provider

2.4 1.6 2.4 1.6

0.5

0.5 3.2 4.8

SAFE Indicates position or location

FF F

Certified/Accredited Test House

3.2 6.4 8.0 4.8

6.4 8.0

Direction of rotation CUTTER RUN ADJUST TUBE

2.4

R R R

1.6

2.4 2.4

Run; system ready to operate

1.6

0.5

0.5 Located on the Foot Pedal switch; this indicates 0.5 3.2 3.2 a change of rotational direction for the 4.8 3.2 4.8 6.4 4.8 8.0 6.4 handpiece 6.4

Load; insert attachment and/or burr. System will not operate

8.0 8.0

Transmitter Interference may occur in the vicinity of equipment marked with this symbol

Located on the Foot Pedal switch; this indicates a change state (on/off) for the Console Irrigation System

FUSE

R Located on the Foot Pedal switch; this indicates SAFE SAFE SAFE SAFE

1.6

3.2

4.8 6.4 8.0

AC Power Source

Located on the irrigation pump; move in this direction to install irrigation tube Located on the irrigation pump; indicates the portion of the irrigation tube to be directed toward the handpiece

0.5

a change of rotational direction for the handpiece

SAFE

2.4

Revolutions per minute

SAFE

Consult Operating Instructions SAFE

Located on the Console; this indicates motor or handpiece connector

Potential Equalization Terminal

on the Console; this indicates F Located Foot Control connector F FR Located on the Console touchpad; this feature is not active on these models F R F R FR Located on the Console; this indicates Forward FR (Clockwise rotation when looking at handpiece

1. Console Control Touchpad; indicates a change state (on/off) for the Console Irrigation System 2. Irrigation Pump; indicates irrigation tube direction toward the irrigation source

SAFE

2.4

1.6

2.4

1.6

0.5

CUTTER RUN ADJUST TUBE

R R

1.6

2.4

3.2 0.5 4.8

1.6

2.4

6.4 0.5 3.2 8.0 4.8 3.2 6.40.5 8.0 4.8 4.8

0.5

3.2 RUN

TUBE

TUBE 8.0

1.6

1.6 2.4

2.4

3.2

4.8 0.5 6.4 8.0 3.2

CUTTER DePuy Synthes Power Tools CUTTER

RUN 4.8 ADJUST ADJUST 6.4

Temperature limits

1.6

SAFE SAFE

6.4 from proximal 3.2end) 8.0 6.4 8.0

2.4

4.8 6.4 8.0

Anspach EG1 Electric System

Product Guide 2.4

Glossary of Symbols

Found on the Console ON/OFF

Product warranty is void if seal is damaged or removed.

Reference number (A.K.A. item number, catalog number, part number)

CAUTION: Refer to accompanying documentation

Lot (A.K.A. lot number, batch number, batch code) Serial number

00/0000

Use by date (A.K.A. expiration date, expiry)

Indicates position, alignment or location (Color; black or red) Located on the irrigation pump; indicates the amount of irrigation from minimum to maximum

Manufacturer Authorized European Union Representative Sterilized using irradiation Single use only (A.K.A. do not reuse) Located on the Console touchpad; indicates foot control activation

Keep dry (A.K.A. protect from moisture) Sterile unless damaged or open CE Mark (A.K.A. CE Mark [notified body number], Conformité Européenne) Meaning: Device complies with applicable EEC Directives DO NOT DISPOSE OF IN HOUSEHOLD WASTE Type B electrical equipment

Anspach EG1 Electric System

Product Guide

DePuy Synthes Power Tools

EG1 High Speed Electric System Assembly and Operating Instructions

The system console houses the electrical components that provide power, control, and cooling functions to the EG1A Handpiece. It provides the user control for all system functions via an integrated touch pad face panel. The system console has connections for the EG1A Handpiece, foot controls, AC power inlet and the main power switch.

Attachment Connection

Caution: Do not use handpiece without an attachment and dissection tool properly locked in place. Damage to the burr lock mechanism could occur.

Irrigation Pump

Face Panel Power Switch

Handpiece Connector Port

Handpiece Housing

EG1A Model Handpiece Shown

Front of System Console

Swivel (270°)

Handpiece Hose

Note: The hose length shown above is shorter than the actual length for easier viewing. Hose length is approximately 12 feet (3.7 m).

Warning: Prior to first use the equipment must be processed as per the included Anspach G1 High Speed System Cleaning and Sterilization instructions. Note: When following these instructions hold handpiece and attachments with distal end pointing away from user. Foot Control Connector Port

System Assembly

1. Place console on a flat sturdy surface. Warning: Console must be outside sterile field.

Back of System Console Irrigation Post Holder

AC Power Inlet* Potential Equalization Terminal

2. Plug hospital-grade AC power cord into AC power inlet on back of console. Plug opposite end of power cord into standard, hospital-grade grounded wall outlet. Caution: Connect to supply mains with protective earth only. Position equipment in such a manner that it provides access to the rear of the system in order to disconnect from mains

3. Insert foot control connector into foot control connector port on front of console with red dot on connector facing up.

Model: SC3002 shown; additional model without Irrigation SC3001 available.

Warning: Foot control must be outside sterile field. Caution: Do not push foot control connector into console connector port when out of alignment.

4. Insert handpiece connector into handpiece connector port on front of console with red dot on connector facing up.

*Power cord provides means to disconnect from the mains.

DePuy Synthes Power Tools

Anspach EG1 Electric System

Warning: Handpiece must remain inside sterile field with exception of handpiece connector which is connected to console. Product Guide

EG1 High Speed Electric System Assembly and Operating Instructions

Caution: Do not push handpiece connector into console connector port when out of alignment.

5. Activate console by depressing power switch located on front of console. Display will illuminate.

6. Refer to Operating Instructions. Warning: Handpiece is fully functional at this time. Caution: Do not use handpiece without an attachment and dissection tool properly locked in place. Damage to the burr lock mechanism could occur. Attachment Assembly 1. Refer to the Anspach G1 Attachment instructions accompanying the specific device. Dissection Tools 1. Refer to the Anspach G1 Dissection Tools instructions accompanying the specific device. Optional Irrigation Tubing Set-Up (SC3002 only) Irrigation Tubing Options 05.001.178.01S Sterile Tubing for Irrigation System 05.001.178.05S Sterile Tubing for Irrigation System, 5 pack, (OUS* only) HOSECLIPS-G1 Irrigation Tube Hoseclips for EG1a 1. Remove sterile irrigation tube from sterile package. 2. Slide irrigation tubing onto proximal end of irrigation attachment clip. 3. Attach irrigation attachment clip to handpiece. 4. Attach irrigation attachment clip to attachment. 5. Route irrigation tube end into non-sterile area. 6. Open twist-lock for irrigation pump in direction of arrow shown. 7. Insert irrigation tube into pump in accordance with marking and close twist lock. 8. Insert IV pole into bracket on back of console. 9. Hang irrigation bag onto IV pole (maximum 1 L bag).

10. Remove protective cap from cannula and connect cannula to irrigation bag. When doing so, make sure connection nipple of cannula is not touched by non-sterile persons while securing irrigation. 11. Secure tubing to handpiece hose using irrigation tube hose clips. 12. To activate, depress “Irrigation” button on front of console. Light on front of console will be on to indicate irrigation is active. 13. To control flow of irrigation, rotate knob located adjacent to irrigation pump. 14. Irrigation can also be activated from certain optional foot controls (see Step 4 of Foot Control Operation). Caution: Tubing can disconnect from connectors without warning if occluded. Do not step on, set equipment on, pinch, kink, clamp, or otherwise occlude tubing during use. Note: Nominal Maximum Flow Rate: 95 ml/min. Irrigation Pump

Irrigation Pump Flow Rate

Irrigation (Activate and Deactivate)

*Available only outside the US (OUS)

Anspach EG1 Electric System

Product Guide

DePuy Synthes Power Tools

EG1 High Speed Electric System Assembly and Operating Instructions

System Operation

Console Operation

Warning · Do not use a dissection tool without an attachment, injury may occur. · Only Use G1 Dissection Tools. Using other than indicated dissection tools may lead to injury. · Use the correct dissection tool and attachment combination or injury may occur. Caution: Do not use handpiece without an attachment and dissection tool properly locked in place. Damage to the burr lock mechanism could occur. Console Default Settings Direction: Forward (clockwise with distal end pointing away from user) Speed: 80,000 RPM (maximum) User Interface: Foot Control Irrigation: OFF

1. To increase or decrease maximum operational speed of handpiece, depress blue arrows located on front of console. Speed increases and decreases in 10,000 RPM increments. Lights on front of console will indicate the maximum Revolutions per minute (RPM). 2. To change rotational direction of handpiece, depress “R” or “F” arrow located on front of console. Direction can only be changed when handpiece is not running. Lights next to “F” and “R” will indicate if console is set to forward or reverse. A series of three beeps indicates console is set to operate in reverse (counterclockwise) and the foot pedal is depressed. Note: The following steps are to operate irrigation on SC3002 console only. 3. To activate irrigation, depress the Irrigation button on front of console. Light will be on to indicate irrigation is active. Note: Irrigation can also be activated from certain optional foot controls (see Step 4 of Foot Control Operation below). 4. To control flow of irrigation, rotate knob located adjacent to irrigation pump. Irrigation flow rate is controlled by position of knob on dial located adjacent to irrigation pump. Note: Buttons with hand and foot symbols on front of console are non-operational. Light next to foot symbol is on indicating console is set to operate in foot control mode. There is no hand control mode for EG1A Handpiece, consoles will always be in foot control mode.

DePuy Synthes Power Tools

Anspach EG1 Electric System

Product Guide

EG1 High Speed Electric System Assembly and Operating Instructions

Foot Control Operation Note: Certain optional foot controls have direction and irrigation control switches. 1. Set operational direction of handpiece (see Step 2 of Console Operation). Warning: Handpiece is fully functional at this time. Caution: Do not use handpiece without an attachment and dissection tool properly locked in place. Damage to the burr lock mechanism could occur. 2. Press foot control pedal to start handpiece. Increase pressure on pedal to increase speed of handpiece and release pressure on pedal to decrease speed of handpiece. 3. Optional (E-FP-DIR and E-FP-DIR/IRR only): To change direction of handpiece, depress Directional Control Switch located on top left of foot control for a minimum of one second. When direction changes, a single beep will sound and light on front of console will indicate direction of rotation once the pedal is depressed. 4. Optional (E-FP-DIR/IRR only): To activate irrigation, depress Irrigation Control Switch on top right of foot control for a minimum of one second. Light on front of console will be on to indicate irrigation is active. Press on foot control pedal to start handpiece and irrigation. Priming Irrigation System 1. Once irrigation tubing is set-up the line may be primed from console.

E-FP Foot Control Directional Control Switch

E-FP-DIR Foot Control

Directional Control Switch

Irrigation Control Switch

2. Press and hold irrigation button on front of console for a minimum of 3 seconds to start priming process. 3. Release irrigation button to stop priming process once irrigation fluid is visible at the handpiece. 4. Confirm light is on indicating irrigation system is operational.

E-FP-DIR/IRR Foot Control

5. If irrigation light is not on, depress irrigation button on front of console to activate irrigation.

Anspach EG1 Electric System

Product Guide

DePuy Synthes Power Tools

EG1 High Speed Electric System Assembly and Operating Instructions

System Operational Assessment 1. Confirm attachment and dissection tools are properly locked in place. 2. Depress foot pedal to assure you have properly functioning device prior to proceeding. 3. Device functions as expected, if device does not function as expected refer to troubleshooting chart. Prior to Use Inspection

LONG-G1 LONG-HD-G1 MEDIUM-G1 MEDIUM-HD-G1

Visually inspect for any damage to the tube.

MIA16-G1 SHORT-G1 SHORT-HD-G1 MA-D20-G1 QD8-G1 QD11-G1

Visually inspect for bent or broken drive shaft and for any damage to the tube.

CRANI-A-G1 CRANI-L-G1

Visually inspect for bent or broken foot.

CRANI-P-G1 CSR60-G1 E-FP E-FP-DIR E-FP-DIR/IRR

Visually inspect for overall damage or missing components. Visually inspect for damage to the electrical cord or connector. Visually inspect for damage or cracks to the housing or pedal. x Visually inspect for damage to the silicone hose or to the electrical connector.

EG1A

SC3001 SC3002

x Connect to console and operate. x The handpiece should operate smoothly. x CAUTION: Do not operate without attachment or dissection tool. Visually inspect for damage or cracks to the housing. Visually inspect for damage to the electrical power cord. Power the system and inspect for illumination of the LEDs. If there is an irrigation pump present check for proper function.

DePuy Synthes Power Tools

Anspach EG1 Electric System

Product Guide

EG1 High Speed Electric System Assembly and Operating Instructions

System Shutdown 1. There are no special procedures for system shutdown. Depress power switch on front of console to shut down system for approximately 2–3 seconds. 2. To disconnect power cord from mains, grasp ridged portion of connector between thumb and forefinger of one hand. Gently pull connector away from console. Connector should remove easily. If not, ensure only ridged portion of connector is pulled. Do not pull on smooth part of connector, as connector will not disengage from console. Additional Information To isolate the device from the mains supply, remove the power cord. All specifications are subject to change. The EG1 System operates continuously without a duty cycle under normal operating conditions. When a A-1 or H-1 alert is indicated on the console display the following duty cycle must be employed: 1 minute ON / 1 minute OFF for unlimited number of cycles for ambient temperatures up to 29°C (85° F). After completing the procedure perform the Inspection and Maintenance steps provided. If the alert does not clear, return the system for repair to DePuy Synthes Power Tools.

Potential Equalization Terminal The purpose of additional potential equalization is to equalize potentials between different metal parts that can be touched simultaneously, or to reduce differences of potential which can occur during operation between the bodies of medical electrical devices and conductive parts of other objects. The EG1 System Console incorporates a dedicated potential equalization terminal that is identified by the symbol and is designed as a means of establishing potential equalization. The potential equalization terminal is specially shaped so as to prevent the risk of accidental disconnection when used as intended and allows the lead to be removed without the need for tools. The terminal is located at the back of the EG1 System console and is accessible to the operator during normal use. The potential equalization terminal on the EG1 System Console cannot be used as a protective earth connection. The EG1 System Console provides an IEC320 inlet with a dedicated protective earth blade. The power supply cord provided with the EG1 System Console does not provide a potential equalization conductor. Prior to using the EG1 System, attach the potential equalization wire to the potential equalization terminal at the back of the EG1 System Console. End of Life Return all equipment for proper disposal. Recommended Manufacturer Inspection Interval It is recommended that the equipment be returned to DePuy Synthes Power Tools at a minimum every 12 months to perform a full product inspection.

Anspach EG1 Electric System

Product Guide

DePuy Synthes Power Tools

Dissection Tool Identification

Warning: All dissection tools are packaged sterile and are single use. Cleaning and Sterilization · Prior to first use the equipment must be processed as per the included Anspach G1 High Speed System 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 G1 High Speed System Cleaning and Sterilization instructions accompanying this device. Attachment and Dissection Tool Selection To assist in identifying the correct attachment and dissection tool combination, attachments have color bars at proximal end that correspond with color bars on dissection tool package labels as shown in Table 1 below. Table 1 Attachment

Color Bars