EMAX 2 PLUS System User Manual

TABLE OF CONTENTS

INTRODUCTION

Anspach Electric System

2

Indications and Contraindications

3

Warnings and Cautions

4

Technical Specifications

5

Glossary of Symbols

10

OPERATING INSTRUCTIONS

eMax 2 Plus Operating Instructions

12

ATTACHMENTS AND DISSECTION TOOL ASSEMBLY

Standard Attachments and Dissection Tool Assembly 20

CARE AND MAINTENANCE

Otologic Curved Micro (OCM) Attachment and Otologic Curved Micro (OCM) Burr Support Sleeves

25

Minimal Access Attachment and Dissection Tool Assembly

26

microSaws and Small Attachments Assembly

28

Perforator Driver

31

Inspection and Maintenance

32

Cleaning Instructions

36

Manual Cleaning

37

Manual Pre-Cleaning Before Mechanical /Automated Cleaning

41

Mechanical / Automated Cleaning Following Manual Pre-Cleaning

47

Lubrication49 Sterilization50 Loading Configuration

52

Troubleshooting53 Ordering Information

54

Image intensifier control

Anspach eMax 2 Plus System User’s Manual

DePuy Synthes Companies

1

ANSPACH ELECTRIC SYSTEM HIGH SPEED PERFORMANCE AND POWER IN A VARIETY OF APPLICATIONS 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, 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 DePuy Synthes Power Tools instruments are manufactured to conform to rigorous quality standards to provide dependable performance.

eMax 2 Plus

EMAX 2 Plus System The EMAX 2 Plus System operates up to 80,000 rpm. It offers variable speed, bi-directional operation, minimal noise levels, and an optional hand control. It is a high performance system that highlights minimal vibration performance, thermal energy management, and high reliability for neurosurgeons, otologists, neurotologists, skull base surgeons, and spinal surgeons. Warning: Before using any of the Anspach High Speed Electric 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.

Spine surgery

If you have any questions after reading this manual, please contact your Depuy Synthes Sales Representative.

2

DePuy Synthes Companies Anspach eMax 2 Plus System

User’s Manual

Neurosurgery and Otologic surgery

INDICATIONS AND CONTRAINDICATIONS

Indications The Anspach eMax 2 Plus High Speed Electric System is intended for cutting and shaping bone including spine and cranium. The Anspach eMax 2 Plus High Speed Electric System is composed of the eMax2Plus Handpiece model; Electric Consoles models SC2100, SC2101, and SC2102; Foot Control models E-FP, E-FP-DIR, E-FP-DIR/IRR, EPLUS-FP, EPLUS-FP-NS; Hand Controls EMAX2-HC and E-HC. Contraindications None.

Anspach eMax 2 Plus System

User’s Manual

DePuy Synthes Companies

1

WARNINGS AND CAUTIONS

Warnings Irrigation is necessary for proper operation.

Use a gentle tapping motion or side-to-side motion and let instrument do cutting.

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.

Do not use excessive force. Forceful side loading of dissection tool may cause fracture of dissection tool, which may cause injury.

Instrument operator and all operating room personnel must wear eye protection.

Dissection tools are disposable and intended for single patient use only. Do not resterilize and / or reuse dissection tools.

Visually inspect for damage before using; do not use if damage is evident.

Use standard protocol for disposal of sharp instruments.

Do not use if the product sterilization barrier or its packaging is compromised.

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

Do not use, or discontinue use of powered equipment exhibiting excessive temperatures that can cause patient injury (necrosis) and / or user discomfort.

Do not operate in an explosive flammable environment.

Use of damaged or improperly maintained power equipment and / or misused powered equipment can result in excessive temperatures.

Portable and Mobile RF communications equipment can affect Medical Electrical Equipment.

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. Only cut visible areas unless an image intensifier is utilized. Delicate structures in proximity to dissection must be thoroughly protected to prevent injury. Maintain firm control of instrument at all times. Do not bend or use as a lever.

Do not modify ground or power cord. Do not allow liquid into console.

Use of accessories or cable other than those provided by DePuy Synthes Companies, and specified for the electric system in use, may result in increased emissions or decreased immunity. Do not use in oxygen rich environment. Do not modify. Modifications could result is loss of electrical safety. Dispose of items contaminated with body fluids with other biohazardous waste. At end of life, recycle or dispose of device in accordance with local and national regulations. No modification of this equipment is allowed. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

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

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

Do not use accessories other than those provided by DePuy Synthes Companies and specified for use with Anspach systems.

Do not operate handpiece without an attachment and the corresponding dissection tool.

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

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

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. 4

DePuy Synthes Companies Anspach eMax 2 Plus System

User’s Manual

TECHNICAL SPECIFICATIONS

eMax 2 Plus Handpiece Specifications Speed: 10,000 – 80,000 rpm Handpiece / hose Length: 3.81 m (12.5 ft) Outside housing (diameter): 18.8 mm (.74 in) Length of housing: 127 mm (5 in) Handpiece weight: 104 g (3.7 oz) Handpiece Hose Weight: 0.59 kg (1.29 lbs)

Foot Pedal (E-FP, E-FP-DIR, E-FP-DIR/IRR) Specifications Size: 26.7 cm  16.5 cm  14.7 cm (10.5 in  6.5 in  8.5 in) Weight: 2.0 kg (4.41 lbs) Cord: 3.66 m (12 ft) in length Fluid Ingress Protection: IPX8

Console (SC2000, SC2100, SC2101, SC2102) Specifications Electrical: Primary: 100 – 240VAC, 50/60 Hz, 250 VA Class I: Protective Earth Fluid Ingress Protection: IPX0 Type B: Applied Part Continuous Operation

Environmental Conditions Temperature Operating: 18° – 30°C (65° –  85°F) Transportation and Storage: – 40 ° – 70°C (– 40° – 158°F)

Mechanical: Size: 31.115 cm  14.6 cm  32.7 cm (12.25 in  5.74 in  12.87 in) Weight: 6.25 kg (13.77 lbs) 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 ES606011:2005, CAN / CSA-C22.2 No.60601-1:08, (3rd Edition) Medical electrical part 1: General requirements for basic safety and essential performance.

Relative Humidity Operating: Transportation and Storage: Atmospheric Pressure Operating: Transportation and Storage:

30 – 70% 10 – 95%

70 – 106 kpa, 0.7 – 1.06bar Not applicable

Patent Information For patent information go to: www.DePuy.com / patentmarking Additional Information To isolate the device from the mains supply, remove the power cord. All specifications are subject to change.

With regard to electrical shock, fire, mechanical hazards, this ETL classified device conforms to AAMI STD ES60601-1 and is certified to CSA STD C22.2 No.60601-1 This device complies with applicable EEC directives.

Anspach eMax 2 Plus System User’s Manual

DePuy Synthes Companies

5

Technical Specifications

Table 1: Emission The Anspach eMax 2 Plus High Speed Electric System is composed of the eMax 2 Plus Handpiece model; Electric Consoles models SC2100, SC2101, and SC2102; Foot Control models E-FP, E-FP-DIR, E-FP-DIR/IRR, EPLUS-FP, EPLUSFP-NS; Hand Controls EMAX2-HC and E-HC.

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

Compliance

Electromagnetic environment – guidance

RF emissions

Group 1

The Anspach High Speed Electric 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 Anspach High Speed Electric 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

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DePuy Synthes Companies Anspach eMax 2 Plus System

User’s Manual

Table 2: Immunity (all devices) Guidance and manufacturer’s declaration – electromagnetic immunity The Anspach High Speed Electric System is intended for use in the electromagnetic environment specified below. The customer or the user of the Anspach High Speed Electric System should assure that it is used in such an environment. Immunity test standard U T (25 cycles)

IEC 60601 test level

Compliance level

Electromagnetic environment – guidance

Electrostatic discharge (ESD) IEC 61000-4-2

±6 kV contact

±6 kV contact

±8 kV air

±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 to line

±1 kV line to line

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

IEC 61000-4-5

±2 kV line to earth

±2 kV line to earth

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

<5 % UT (>95 % dip <5 % UT (>95 % dip in UT) for 0.5 cycle in UT) for 0.5 cycle

IEC 61000-4-11

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

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

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

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

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

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

Note: U T is the a.c. mains voltage prior to application of the test level. Power frequency (50 / 60 Hz) magnetic field

3 A/m

3 A/m

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

IEC 61000-4-8

Anspach eMax 2 Plus System User’s Manual

DePuy Synthes Companies

7

Technical Specifications

Table 3: Immunity (not life-supporting devices) Guidance and manufacturer’s declaration – electromagnetic immunity The Anspach High Speed Electric System is intended for use in the electromagnetic environment specified below. The customer or the user of the Anspach High Speed Electric System should assure that it is used in such an environment. Immunity test standard

IEC 60601 test level

Compliance level

Electromagnetic environment – guidance

Conducted RF

3 Vrms

3V

IEC 61000-4-6

150 kHz to 80 MHz

Radiated RF

3 V/m

Portable and mobile RF communications equipment should be used no closer to any part of the Anspach High Speed Electric System, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

IEC 61000-4-3

80 MHz to 2.5 GHz

3 V/m

Recommended separation distance d = 1.2 √P d = 1.2 √P

80 MHz to 800 MHz

d = 2.3 √P

800 MHz to 2.7 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 surveya a should 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 Anspach High Speed Electric System is used exceeds the applicable RF compliance level above, the Anspach High Speed Electric System, or the device which contains it, should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device containing the Anspach High Speed Electric System. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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DePuy Synthes Companies Anspach eMax 2 Plus System

User’s Manual

Table 4: Recommended separation distances (not life-supporting devices) Recommended separation distances between portable and mobile RF communications equipment and the Anspach High Speed Electric System The Anspach High Speed Electric System is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Anspach High Speed Electric System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Anspach High Speed Electric 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 150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

d = 1.2 √P

d = 1.2 √P

d = 2.3 √P

0.01

12 cm

12 cm

23 cm

0.1

38 cm

38 cm

73 cm

1

1.2 m

1.2 m

2.3 m

10

3.8 m

3.8 m

7.3 m

100

12 m

12 m

23 m

W

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: T hese guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Anspach eMax 2 Plus System User’s Manual

DePuy Synthes Companies

9

GLOSSARY OF SYMBOLS

30 Sec ON / 30 Sec OFF

Duty Cycle of the DRIVER

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

Company Logo

 Located on the Foot Pedal switch this indicates a change of rotational direction for the Handpiece

Direction of rotation Direction of rotation for lock position

SAFE

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

IndicatesSAFE setting, position, or location

SAFE

Indicates setting, position, or location

SAFE

SAFE

SAFE

CUTTER RUN SAFE CUTTER ADJUST CUTTER SAFE IndicatesSAFE the drill tip exposure RUN RUN TUBE ADJUST ADJUST SAFE

Symbol with yellow background: CAUTION: Refer to accompanying documentation

SAFE

CUTTER RUN ADJUST TUBE CUTTER CUTTER RUN CUTTER RUN ADJUST RUN CUTTER ADJUST TUBE ADJUST RUN CUTTER TUBE CUTTER TUBE ADJUST RUN RUN CUTTER TUBE ADJUST ADJUST RUNTUBE TUBE CUTTER ADJUST CUTTER CUTTER RUN TUBE CUTTER RUN RUN ADJUST RUN ADJUST ADJUST CUTTER TUBE TUBE ADJUST TUBE RUN TUBE ADJUST

SAFE

SAFE

SAFE

TUBE

CUTTER TUBE

SAFE

RUN ADJUST

SAFE SAFE

SAFE

SAFE

F



TUBE ADJUST CUTTER TUBE RUN ADJUST CUTTER TUBE RUN ADJUST



Indicates position or location

F R F or location F Indicates position F F R FR IndicatesF action of rotation and position R F R and Release for Secure (LOCK) R F F (UNLOCK) R R FR F R Direction of R Rrotation R TUBE CUTTER RUN ADJUST 0.5

TUBE

4.8

0.5

0.5 3.2 6.4 8.0 TUBE 4.8 8.0 4.8 6.4 3.2 6.4 8.0 0.5 4.8 8.0 0.5 6.4 3.2 8.0 0.5 3.2 4.8 3.2 4.8 6.4 0.5 4.86.4 8.0 3.2 6.48.0 8.0 4.8

3.2

4.8

6.4 8.0

1.6 1.6

1.6

2.4

2.4

2.4

1.6

6.4 8.0

Direction of rotation

2.4

1.6

2.4

0.5

1.6

2.4

Located on 0.5 the Console this indicates 1.6 3.2

2.4

4.8

6.4 8.0

0.5 3.2

4.8

2.4 1.6 1.6

Located on the Console this indicates 2.4 Motor or Handpiece unit 1.6

Foot Control activation F F R Located on the Console this indicates R F Hand Control activation R F R   Located on the Console this indicates Forward (Clockwise rotation when FR 2.4

Direction of rotation for lock position



1.6

1.6

1.6

F R F R R FR

2.4

1.6

4.8

CUTTER 6.4 4.83.20.5 8.0 3.2 RUN 6.4 0.5 4.8 8.0 6.43.2 ADJUST 4.8

F F

2.4 SAFE

3.2

0.5 3.2

Consult Operating Instructions

SAFE

1.6

6.4 TUBE 0.5 8.0 2.4 3.2 0.5

1.6

SAFE

2.4

1.6

0.5

AC Power Source

SAFE

Indicates the attachmentCUTTER setting, refer TUBE RUN CUTTER to MA-D20 and MA-DRIVER section in ADJUST RUN CUTTER this document for further details TUBE ADJUST RUN

2.4

2.4

6.4 0.5 8.0 0.5 3.2

3.24.8 0.5 6.4 4.8 8.0 3.2 6.4 8.0 4.8 0.5 6.4 8.0 3.2

2.4

3.2 0.5 4.8

6.4 3.2 8.0

4.8

6.4 8.0

2.4

1.6

2.4

1.6

2.4

1.6

2.4

1.6

2.4

1.6

looking at Handpiece from proximal 4.8 0.5 2.4 6.4 1.6 end) 8.0 3.2

R F  Located on the Console this indicates 4.8

6.4 8.0 0.5

R

2.4 Reverse 3.2 (Counterclockwise rotation 1.6 4.8 6.4 8.0 when looking at Handpiece from proximal0.5 end)

 Located on the Foot Pedal switch this indicates a change of rotational direction for the Handpiece



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

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

3.2

SAFE

SAFE

11 SAFE

DePuy Synthes Companies Anspach eMax 2 Plus System CUTTER

User’s Manual

4.8

Revolution per Minute 6.4 8.0

R

Located on the Console this indicates a change of irrigation rate for the Console Irrigation System Located on the Console this indicates a change of rotational speed rate for the Handpiece

Single Use Only (A.K.A. Do Not Reuse) CAUTION: Refer to accompanying documentation Keep Dry (A.K.A. Protect from Moisture) Sterile unless damaged or open

Temperature Limits

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

Equipotential post location 

Found on the Console ON / OFF

Located on the Console Irrigation Pump 2.4 1.6 this indicates a possible finger pinch point

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

0.5 2.4

2.4 3.2  1.6 4.8 6.4 Located on the Console 8.0 2.4 1.6 Irrigation Pump these symbols 0.5 are not used by the user since 3.2 0.5 4.8 the pump is self adjusting to 6.4 3.2 8.0 the Irrigation Tube diameter 4.8 1.6

1.6

1.6

2.4

2.4

2.4

1.6

Unlock (Load)

0.5

0.5

0.5 3.2

3.2

0.5 4.8 4.8 3.2 6.4 6.4 8.0 8.0

4.8 3.2 6.4 4.8 8.0 6.4 8.0

6.4 8.0

Transmitter Interference may occur in the vicinity of equipment marked with this symbol. Type B Electrical Equipment

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

Product warranty is void if seal is damaged or removed.

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

DO NOT DISPOSE OF IN HOUSEHOLD WASTE

Serial Number

Instrument System Key

Use By Date (A.K.A. Expiration Date, 00/0000 Expiry) Manufacturer

EM eMax 2 Plus

Latex-free Certification Products not made with natural rubber latex.

Authorized European Union Representative Sterilized Using Irradiation

Anspach eMax 2 Plus System User’s Manual

DePuy Synthes Companies

11

EMAX 2 PLUS OPERATING INSTRUCTIONS

The system console houses the electrical components that provide power, control, and cooling functions to the eMax 2 Plus handpiece. It provides the user control for all system functions via an integral touch pad face panel. The system console has connections for the eMax 2 Plus handpiece, foot controls, AC power inlet and the main power switch. The eMax 2 Plus High Speed Handpiece operates continuously at speeds up to 80,000 rpm.

Power Switch (Rear of Unit)

Face Panel

Handpiece Connector Port

Foot Control Connector Port

Back of System Console

IV Pole Mount

Power Switch

AC Power Inlet*

Swivel (270°)

Attachment Connection Knurled Knob

Protective Cap Handpiece Housing Handpiece Hose

Handpiece Hose Connector

* If two foot controls or two handpieces are connected upon startup of console it will default to Foot Control 1 and/or Handpiece 1. ** “Port” LED on console face panel does not illuminate when this accessory is connected to console.

Note: The hose length shown above is shorter than the actual length for easier viewing. Hose length is approximately 12 feet. • Power cord provides means to disconnect from the mains. • Position equipment in such a manner that provides access to the rear of the system in order to disconnect from mains.

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DePuy Synthes Companies Anspach eMax 2 Plus System

User’s Manual

System Assembly 1. Plug the hospital grade AC power cord into the AC power inlet on the back of the console. Plug the opposite end of the power cord into a standard, hospital grade grounded wall outlet. Connect to supply mains with protective earth only. 2. Insert foot control cord connector into Foot Control 1 connector port. (A second foot control cord may be connected into Foot Control 2 connector port on applicable consoles.) Foot control cord connector is keyed. Align foot control cord connector with port on front of console. Do not push foot control cord connector into console connector port when out of alignment. 3. Plug handpiece hose connector into Handpiece 1 connector port located on front of console. (A second handpiece could be connected into Handpiece 2 connector port on applicable consoles.) Handpiece hose connector is keyed. Align handpiece hose connector with connector port on front of console. Do not push handpiece hose connector into console connector port when out of alignment. 4. Activate console by depressing power switch located on the back of the console to the “I” position. Appropriate Face Panel Light Emitting Diodes (LED) illuminate, and a beep sounds. 5. For operating instructions see Console Face Panel Operation and Foot Control Operation below. Note: Handpiece is fully functional at this time. Warning: Before first use clean and sterilize as indicated.

Anspach eMax 2 Plus System User’s Manual

DePuy Synthes Companies

11

eMax 2 Plus Operating Instructions

Operating Instructions Upon startup, console is set to operate handpiece in forward (clockwise when viewed from the proximal end of the Handpiece) direction at maximum speed and display reads 80,000 RPM. System operation, including optional irrigation, can be controlled from console face panel. On applicable consoles LED’s on face panel correspond to connector ports on connector panel. System operation can also be controlled by several available foot control options and an optional hand control. Console Face Panel Operation 1. To increase or decrease speed of handpiece, depress blue arrows located on console face panel. Speed increases and decreases in 10,000 RPM increments. Each LED will indicate the max RPM: 10 = 10,000 RPM 20 = 20,000 RPM 30 = 30,000 RPM 40 = 40,000 RPM 50 = 50,000 RPM 60 = 60,000 RPM 70 = 70,000 RPM 80 = 80,000 RPM 2. To change direction, depress “R” or “F” arrow located on console face panel. Console beeps once, indicating handpiece direction has changed. Direction can only be changed when handpiece is not running. A series of three beeps indicates console is set to operate handpiece in reverse/counterclockwise direction. LED on console face panel located to left of “F” indicates forward direction. LED located to left of “R” indicates reverse direction. 3. Optional: To activate irrigation, depress “Irrigation” button on face panel. LED illuminates. To control flow of irrigation, depress arrows located to right of irrigation button on face panel.

Increase Speed

Decrease Speed

LED: Forward F: Forward

R: Reverse LED: Reverse

Hand Control LED: Foot Control #1

LED: Foot Control #2

Irrigation Increase / Decrease

Foot Control Irrigation ON /OFF

Note: Depressing simultaneously the Irrigation Increase and Decrease buttons will display the Console Software version as a two digit number. For example: XY this to be interpreted as Software Version X.Y. On Consoles with no Irrigation (SC2102) the buttons are not marked but are located in the same location which are detectable by feel.

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DePuy Synthes Companies Anspach eMax 2 Plus System

User’s Manual

Foot Control Operation Certain optional foot controls have direction and irrigation control switches. 1. See Step 2 of Console Face Panel Operation to set operational direction of handpiece. 2. Optional: Depress “Foot” button on face panel to activate Foot Control 1, depress again to activate Foot Control 2. Only one foot control may be active at a time.

Directional Control Switch

Irrigation Control Switch

EPLUS-FP or EPLUS-FP-NS Foot Control

Note: Handpiece is fully functional at this time. 3. Press on 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. 4. Optional: 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 LED on console face panel indicates direction of rotation. Direction can only be changed when handpiece is not running. 5. Optional: To activate irrigation, depress Irrigation Control Switch on top right of foot control for a minimum of one second and then step on center of foot control pedal. Upon activation, LED on face panel illuminates; irrigation pump and handpiece start.

E-FP Foot Control

Directional Control Switch

E-FP-DIR /IRR Foot Control

Anspach eMax 2 Plus System User’s Manual

DePuy Synthes Companies

11

eMax 2 Plus Operating Instructions

Hand Control Assembly and Operation Optional hand control attachment for handpiece allows user to control operation with a lever attached to handpiece. Warnings: • Do not expose handpiece to magnets (such as laying handpiece on magnetic drapes) when in hand control mode, as handpiece operation may occur. • It is recommended that a craniotome not be used in conjunc­tion with Hand Control. Excessive rotational force on hand control may move it resulting in handpiece shutting down.

Dimple

Inser

t to

L o ck

Notch lines up with Dimple eMax 2-HC

1. Upon console start-up Hand Control is OFF. LED is not illuminated. 2. Rotate handpiece until small dimple at proximal end (hose end) of handpiece faces up. Slide hand control over distal end of handpiece such that notch on hand control slides over dimple at proximal end (hose end) of handpiece. Slide Hand Control onto handpiece until secure. 3. To activate Hand Control, depress “Hand” button on console face panel. This deactivates Foot Control; Hand Control LED on face panel illuminates. 4. To prevent inadvertent operation, ensure silver lever on Hand Control is fully inserted in “Lock” position. 5. Extend silver lever from “Lock” position for operation. 6. Apply pressure on Hand Control to operate handpiece. Note: Handpiece is fully functional at this time. 7. To deactivate Hand Control, depress “Foot” button on console face panel. To remove hand control from handpiece, slide towards distal end of handpiece and remove.

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DePuy Synthes Companies Anspach eMax 2 Plus System

User’s Manual

Optional Irrigation Assembly and Operation (Excludes SC2102) 1. Upon start-up Irrigation is OFF. LED is not illuminated. 2. Depress the button located on the right side of the console to eject pump head. 3. Insert IV pole into bracket on back of console. 4. Hang irrigation bag onto IV Pole. 5. To activate, depress the “Irrigation” button on the face panel. LED illuminates. 6. To control flow of irrigation, depress arrows located to right of irrigation button on face panel. 7. Irrigation can also be activated from certain optional Foot Controls (see Step 5 of Foot Control Operation). Depress Irrigation Control Switch on top right of the foot control. Upon activation, LED on face panel illuminates.

Irrigation Pump Release Button

➢ Increase Flow ➣

Irrigation Tubing Set-up IRRIGATE-TUBE Sterile Tubing and Hoseclips for Irrigation System IRRIGATE-TUBE-HF Sterile High Flow Tubing and Hoseclips for Irrigation System 05.001.178.01S Irrigation Tube Set, sterile, single pack

Irrigation Pump

Decrease Flow

LED: Irrigation Flow Rate Irrigation (Activate and Deactivate)

1. Lift top of pump head and insert large diameter tubing. Refer to diagram on irrigation pump housing to ensure tubing is routed properly (smaller dia­meter tubing flows towards the Anspach handpiece housing). 2. Close lid on pump head. 3. Insert bayonet end of tubing into irrigation bag. 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. Irrigation Attachment Clip Assembly Refer to “Components” section for part numbers. 1. Slide irrigation tubing onto proximal end of irrigation attachment clip. 2. Attach irrigation attachment clip to handpiece. 3. Secure tubing to handpiece hose using Hoseclips, which are included with tubing.

Anspach eMax 2 Plus System User’s Manual

DePuy Synthes Companies

11

eMax 2 Plus Operating Instructions

System Shutdown 1. There are no special procedures for system shutdown. 2. To disconnect power cord from mains, grasp ridged portion of connector between thumb and forefinger of one hand. Gently pull the connector away from the console. The connector should remove easily. If not, ensure only the ridged portion of the connector is pulled. Do not pull on the smooth part of the con­ nector, as the connector will not disengage from the console. Cautions: • Do not sterilize, and do not allow liquid into pump. • Do not operate with pump head open.

Warnings: • Irrigation tubing, attachment clip, and hose clip are for SINGLE USE ONLY. • Avoid stacking or placing the eMax 2 Plus System consoles near other electrical equipment. If the eMax 2 Plus System consoles must be stacked or used adjacent to other electrical equipment, it should be observed to verify normal operation prior to use • The eMax 2 Plus System is Medical Electrical. Equipment, requiring special precautions related to EMC, and for this reason must be put into service as described in this product manual. • Firm control of the eMax 2 Plus must be maintained at all times. Never force the dissection tool. Let the instrument do the cutting. • Only Anspach cutting burrs should be used with the eMax 2 Plus. • Always use continuous irrigation to prevent heat build-up. Never use the attachments as a retractor to bend or pry. • 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.” Note: If fuse replacement is necessary, use only Time Delay fuse rated 2.5A, 250V. Item to be replaced by a DePuy Synthes Companies repair facility ONLY.

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DePuy Synthes Companies Anspach eMax 2 Plus System

User’s Manual

Console Indicators Code

Description

Audible Signal*

E1, E8

System Fault

None Turn Power switch to off, and then back on. If fault does not clear, return console and handpiece to DePuy Synthes Power Tools for service.

E2

Handpiece Lock 10 slow beeps Engaged

Rotate the knurled knob on handpiece clockwise to ensure the handpiece is not locked.

E3

Handpiece Stall 10 fast beeps Warning

Remove pressure from foot control (or hand control), remove cutter from stalled location and restart handpiece.

E4, E5

Fault in Handpiece

E6, E7

Handpiece overheat 5 second beep warning, impending handpiece shutdown

None Return console and handpiece to DePuy Synthes Companies for service.

E9

Handpiece type None not recognized None

Handpiece set to reverse

Corrective Action

Reduce or remove load from handpiece to allow handpiece to cool. If load is not reduced sufficiently, handpiece will shut down 30 seconds after tone is heard and/or code is displayed. Disconnect connector and reconnect to console. If fault does not clear, return handpiece and consol to DePuy Synthes Companies for service.

3 beeps

* Note: Consoles with Software Version 3.0 and higher do not generate an Audible Signal for Codes E1–E9. To determine software version, press the irrigation rate buttons at the same time on the console touchpad. The console will display two digits. Example Only: “30” means version 3.0. On nonirrigation console models, the buttons can be found in the same location, although they are not marked.

Anspach eMax 2 Plus System User’s Manual

DePuy Synthes Companies

11