Anspach Electric Systems Instructions for Use ver AC Oct 2012

Table of Contents

Introduction

Operating Instructions

Attachments and Dissection Tool Assembly

Synthes Anspach

2

High Speed Electric Systems

2

Indications

3

Warnings and Cautions

4

Technical Specifications

5

Glossary of Symbols

10

eMax 2 and eMax 2 Plus

12

e12 Small Bone System

20

Standard Attachments and Dissection Tool Assembly

21

Minimal Access Attachment and Dissection Tool Assembly 27

Care and Maintenance

Micro Curved Attachment (MCA) and Curved Burr Support Sleeves (Curved Burr)

29

microSaws and Small Attachments Assembly

30

Sagittal Saw

33

Compact SpeedReducer

34

Inspection and Maintenance

35

Manual Cleaning Procedure

39

Sterilization

41

Troubleshooting

42

Ordering Information

44

Anspach Electric Systems

Instructions for Use

Synthes

1

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

Synthes Anspach Synthes Anspach 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 Synthes Anspach instruments are manufactured to conform to rigorous quality standards to provide dependable performance. Warning: Before using any of the Synthes 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. To schedule a hands-on training course, please contact your local Sales Representative. If you have any questions after reading this manual, please contact your local Sales Representative.

eMax 2 Plus

2

Synthes

High Speed Electric Systems The eMax 2 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, Neurotologists, Skull Base Surgeons, Spinal Surgeons, and Otolaryngologists. The eMax 2 Plus incorporates all of the features of the eMax 2, but with a higher degree of torque. The additional torque is beneficial for power demanding procedures. The e12 is designed specifically to meet the demands of surgical applications requiring a low speed instrument at a high performance level that is the hallmark of Anspach systems. It combines the advantages of an electric system with an optimum balance of power, smooth operation, and ergonomic comfort. The eMax 2 and eMax 2 Plus System Consoles provide power to the e12 for variable speed operation up to 12,000 rpm with your choice of either foot or hand control. The e12 quick disconnect mechanism provides simple exchange of Synthes Anspach microSaw attachments and small attachments (J-Latch and Jacobs Chuck) resulting in a complete range of attachments and tools for all of your small bone procedures.

e12

Anspach Electric Systems

Instructions for Use

Indications

The Synthes Anspach High Speed Electric Systems are intended for cutting and shaping bone including spine and cranium. The Synthes Anspach High Speed Electric System is composed of Handpiece models eMax2, eMax2 Plus, E12, and E-Saggital; Electric Consoles models SC2000, SC2000U, SC2100, SC2101, and SC2102; Foot Control models E-FP, E-FP-DIR, E-FP-DIR/IRR, EPLUS-FP, EPLUS-FP-NS, EMAX2-FP, EMAX2-FP-NS; Hand Controls EMAX2-HC, E-HC and E12-HC.

Spine surgery

Neurosurgery and ENT

Anspach Electric Systems

Instructions for Use

Synthes

3

Warnings and Cautions

Warnings 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.

Use a gentle tapping motion or side-to-side motion and let instrument do cutting. Do not use excessive force. Forceful side loading of dissection tool may cause fracture of dissection tool, which may cause injury. Dissection tools are disposable and intended for single patient use only. Do not re-sterilize and/or re-use dissection tools. 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.

Do not allow liquid into console.

Use caution to avoid cutting or tearing gloves while handling dissection tools.

Use of accessories or cable other than those provided by Synthes Anspach, and specified for the electric system in use, may result in increased emissions or decreased immunity.

Dissection tools must be adequately retained within attachment to prevent distal migration, which may cause injury.

Do not modify ground or power cord.

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

Do not use in oxygen rich environment.

Confirm attachment is proper size for dissection tool and that it is secure.

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

Gently pull on dissection tool shaft to ensure it is fully seated and properly installed.

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

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

At end of life, recycle or dispose of device in accordance with local and national regulations. Irrigation Tubes contain DEHP a type of phthalate.

Irrigation is necessary for proper operation.

No modification of this equipment is allowed.

Maintain firm control of instrument at all times.

To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

Do not bend or use as a lever.

Cautions 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 Synthes Anspach and specified for use with Anspach systems.

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

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

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

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

Do not engage safety mechanism while handpiece is running; doing so makes safety mechanism inoperable.

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Synthes

Anspach Electric Systems

Instructions for Use

Technical Specifications

eMax 2 and 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) Console (SC2000, SC2100, SC2101, SC2102) Specifications Electrical: Primary: 100 –240 VAC, 50/60 Hz, 250 VA Class I: Protective Earth Fluid Ingress Protection: IPX0 Type B: Applied Part Continuous Operation Mechanical: Size: 31.115 cm⳯14.6 cm⳯32.7 cm (12.25 in⳯5.74 in⳯12.87 in) Weight: 6.25 kg (13.77 lbs) The device complies with the following standards: IEC 60601-1 / IEC 60601-1-2

Foot Pedal (E-FP, E-FP-DIR, E-FP-DIR/IRR) Specifications Size: 26.7 cm⳯16.5 cm⳯14.7 cm (10.5 in⳯6.5 in⳯8.5 in) Weight: 2.0 kg (4.41 lbs) Cord: 3.66 m (12 ft) in length Fluid Ingress Protection: IPX8 Environmental Conditions Temperature Operating: 18 °–30 °C (65 °– 85 °F) Transportation and Storage: –40 °–70 °C (–40 °–158 °F) Relative Humidity Operating: 30–70 % Transportation and Storage: 10–95 % Atmospheric Pressure Operating: 70–106 kPa, 0.7–1.06 bar Transportation and Storage: Not applicable Patent Information Synthes Anspach products are manufactured under one or more of the following U.S. Patent Nos. RE 37,358; 5,405,348; 5,601,560; 5,630,818; 5,741,084; 5,904,687; 6,607,533; 6,733,218; 6,746,153; 6,749,341; 6,969,368; 7,128,544; 7,144,415; 7,217,090; 7,255,546; 7,261,526 and 7,458,979. Additional U.S. and International patents pending.

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

Additional Information To isolate the device from the mains supply, remove the power cord. All specifications are subject to change.

This device complies with applicable EEC directives.

Anspach Electric Systems

Instructions for Use

Synthes

5

Technical Specifications

Table 1: Emission The Synthes Anspach High Speed Electric System is composed of Handpiece models eMax2, eMax2 Plus, E12, and E-Saggital; Electric Consoles models SC2000, SC2000U, SC2100, SC2101, and SC2102; Foot Control models E-FP, E-FP-DIR, E-FP-DIR/IRR, EPLUS-FP, EPLUS-FP-NS, EMAX2-FP, EMAX2-FP-NS; Hand Controls EMAX2-HC and E12-HC. Guidance and manufacturer’s declaration – electromagnetic emissions The Synthes Anspach High Speed Electric System is intended for use in the electromagnetic environment specified below. The customer or the user of the Synthes Anspach High Speed Electric System should assure that it is used in such an environment. Emission test

Compliance

Electromagnetic environment – guidance

RF emissions CISPR 11

Group 1

The Synthes 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.

RF emissions CISPR 11

Class A

Harmonic emissions IEC 61000-3-2

Class A

The Synthes 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.

Voltage fluctuations / flicker emissions IEC 61000-3-3

Complies

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Synthes

Anspach Electric Systems

Instructions for Use

Table 2: Immunity (all devices) Guidance and manufacturer’s declaration – electromagnetic immunity The Synthes Anspach High Speed Electric System is intended for use in the electromagnetic environment specified below. The customer or the user of Synthes 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

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 IEC 61000-4-4

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

±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.

Surge IEC 61000-4-5

±1 kV line to line ±2 kV line to earth

±1 kV line to line ±2 kV line to earth

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

Voltage dips, short interruptions and voltage variations on power supply lines IEC 61000-4-11

<5% UT (0.5 cycle)

<5% UT (0.5 cycle)

40% UT (5 cycles)

40% UT (5 cycles)

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

70% UT (25 cycles)

70% UT (25 cycles)

<5% UT for 5s

<5% UT for 5s

Note: UT is the a.c. mains voltage prior to application of the test level. Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

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.

Anspach Electric Systems

Instructions for Use

Synthes

7

Technical Specifications

Table 3: Immunity (not life-supporting devices) Guidance and manufacturer’s declaration – electromagnetic immunity The Synthes Anspach High Speed Electric System is intended for use in the electromagnetic environment specified below. The customer or the user of the Synthes 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 IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3V

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

3 V/m

Portable and mobile RF communications equipment should be used no closer to any part of the Synthes Anspach High Speed Electric 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 √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 survey,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 Synthes Anspach High Speed Electric System is used exceeds the applicable RF compliance level above, the Synthes 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 Synthes 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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Synthes

Anspach Electric Systems

Instructions for Use

Table 4: Recommended separation distances (not life-supporting devices) Recommended separation distances between portable and mobile RF communications equipment and the Synthes Anspach High Speed Electric System The Synthes 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 Synthes 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 Synthes 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

W

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

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. Note 3: An additional factor of 10/3 is used in calculating the recommended separation distance to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas.

Anspach Electric Systems

Instructions for Use

Synthes

9

Glossary of Symbols

30 Sec ON / 30 Sec OFF

Duty Cycle of the e12 system and DRIVER

Located on the Foot Pedal switch this indicates a change state (on/off) 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

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

Indicates setting, position, or location SAFE

Indicates setting, position, or location

Symbol with yellow background: CAUTION: Refer to accompanying documentation

Indicates the drill tip exposure

AC Power Source Consult Operating Instructions

CUTTER RUN ADJUST TUBE

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

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

Indicates position or location

2.4 Located on the Console1.6this indicates Foot Control activation 2.4 0.5

2.4

1.6

3.2

2.4

Indicates position or location

1.6

4.8 6.4 8.0

2.4

1.6

2.4 1.6

2.4

Indicates action of rotation and position for Secure (LOCK) and Release (UNLOCK) 1.6 0.5

0.5

0.5

3.2

6.4 4.8 8.0

3.2

6.4 8.0

4.8 6.4 8.0

Direction of rotation 0.5

0.5

1.6

0.5

1.6

3.2

3.2

0.5

2.4

2.4

F

Direction of rotation for lock position 8.0 3.2

4.8

6.4 6.4 8.0 8.0

6.4 8.0

Direction of rotation

6.4 8.0 0.5

3.2 8.0

0.5 3.2

6.4 8.0

4.8

2.4

1.6

Located on the Console this indicates Forward (Clockwise rotation when looking at Handpiece from proximal end) 3.24.8 0.5 6.4 4.88.0 3.2 6.4 8.0 4.8 0.5 6.4 8.0 3.2

4.8 0.5 6.4 8.0 3.2

6.4

6.4 8.0 8.0 3.2 3.2 4.8 0.5 4.8 4.8 6.4

2.4

1.6

4.8

2.4 2.4

2.4 4.8 1.6 0.5 4.8 6.4 8.0 6.4 2.4 0.5 0.5 3.2 8.01.6 2.4 2.4 0.5 1.6 1.6 3.2 4.83.2 0.5 6.4 2.4 4.8 4.8 8.0 3.2 1.6 3.2 6.4 6.4 4.8 8.0 8.0 4.8 0.5 0.5

3.2

2.4

1.6

3.2

1.6

1.6

0.5

Located on the3.2 Console this indicates 0.5 4.8 Hand Control activation 6.4

2.4

1.6

3.2

4.8

1.6

2.4

1.6

2.4

1.6

2.4 1.6

Located on the Console this indicates Reverse (Counterclockwise rotation when looking at Handpiece from proximal end) 4.8

R

6.4 0.5 8.0

2.4

3.2

4.8

1.6

6.4 8.0

0.5 3.2

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

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Synthes

Anspach Electric Systems

Instructions for Use

4.8

Revolution per Minute 6.4 8.0

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

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

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

Sterile unless damaged or open

Temperature Limits Equipotential post location

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

Found on the Console ON/ OFF

Located on the Console Irrigation Pump 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

2.4 1.6

2.4

1.6

2.4 2.4

1.6 1.6

0.5

0.5

2.4 1.6 2.4

3.2

3.2

4.84.8

1.6

6.4

6.4 0.5 8.08.0 0.5

3.2 3.2 4.8 4.8 6.4 6.4 8.0 0.5 8.0

3.2

4.8

1.6

0.5 0.5 3.2

4.8

3.2

4.8

2.4

Located on the Console Irrigation Pump these symbols are not used by the user since the pump is self adjusting to the Irrigation Tube diameter

Lock (Run) Unlock (Load)

6.4 6.4 8.0 8.0

6.4 8.0

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

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

Type B Electrical Equipment

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

Product warranty is void if seal is damaged or removed.

Serial Number

00/0000

Use By Date (A.K.A. Expiration Date, Expiry) Instrument System Key Manufacturer

EM eMax 2 and eMax 2 Plus E12 e12

Authorized European Union Representative Sterilized Using Irradiation Single Use Only (A.K.A. Do Not Reuse)

Latex-free Certification

There is no latex material in Synthes Anspach products or packaging.

CAUTION: Refer to accompanying documentation

Anspach Electric Systems

Instructions for Use

Synthes

11

eMax 2 and eMax 2 Plus Operating Instructions

The system console houses the electrical components that provide power, control, and cooling functions to the eMax 2 and eMax 2 Plus handpieces. 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 and eMax 2 Plus handpieces, foot controls, AC power inlet and the main power switch.

Face Panel

The eMax 2 and eMax 2 Plus High Speed Handpieces operate continuously at speeds up to 80,000 rpm.

Handpiece Connector Port

SC2101

SC2102

• • • • • • •

• • • • • • •

Accessories

E-SAGITTAL**

•

•

•

•

•

E12**

•

•

•

•

•

Handpieces

EMAX2PLUS

•

•

•

•

E-HC

SC2100 • • • • • • •

IV Pole Mount E12-HC

SC2000U • • • • • • •

Foot Control Connector Port

Back of System Console

Hand Controls

EMAX2-HC

SC2000 • • • • • • •

Foot Controls

E-FP E-FP-DIR E-FP-DIR/IRR EMAX2-FP EPLUS-FP EMAX2-FP-NS EPLUS-FP-NS

Active Direction Control Switch Active Irrigation Control Switch

Foot Control Features

Consoles

Power Switch

Power Switch • • • •

• • •

AC Power Inlet*

Swivel (270°)

Attachment Connection

Console Features

Knurled Knob

•

•

Protective Cap •

Handpiece Housing Handpiece Hose

EMAX2

•

•

•

Two Foot Control Ports*

•

•

•

Two Handpiece Ports*

•

•

•

•

•

•

•

Handpiece Hose Connector Console Irrigation

•

•

•

•

*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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Synthes

Anspach Electric Systems

Instructions for Use

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.

Anspach Electric Systems

Instructions for Use

Synthes

13

eMax 2 and eMax 2 Plus Operating Instructions

Operating Instructions  Increase Speed

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.

 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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Synthes

Anspach Electric Systems

Instructions for Use

Foot Control Operation Certain optional foot controls have direction and irrigation control switches.

Directional Control Switch

Irrigation Control Switch

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.

EMAX2-FP or EMAX2PLUS-FP 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 Foot Control

Anspach Electric Systems

Instructions for Use

Synthes

15

eMax 2 and 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.

Dimple

Warning: 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. 1. Upon console startup 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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Synthes

Anspach Electric Systems

Instructions for Use

Notch lines up with Dimple Insert to Lock

eMax2-HC

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

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 Synthes 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 “Ordering Information” 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 Hose Clips, which are included with tubing.

Anspach Electric Systems

Instructions for Use

Synthes

17

eMax 2 and 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 connector, as the connector will not disengage from the console.

Warning:

Caution: – Do not sterilize, and do not allow liquid into pump.

– The eMax 2 and eMax 2 Plus Systems are Medical Electrical Equipment, requiring special precautions related to EMC, and for this reason must be put into service as described in this product manual.

– Do not operate with pumphead open. – Do not use eMax 2 or eMax 2 Plus with MS-OSC or MS-SAG. Attempting to do so will result in damage to the saws and possible damage to the eMax 2 and eMax 2 Plus Motors.

– Irrigation tubing, attachment clip, and hose clip are for SINGLE USE ONLY. – Avoid stacking or placing the eMax 2 and eMax 2 Plus System consoles near other electrical equipment. If the eMax 2 or 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.

– Firm control of the eMax 2 and eMax 2 Plus must be maintained at all times. Never force the dissection tool. Let the instrument do the cutting. – Only Synthes Anspach XMax/microMax/eMax cutting burrs should be used with the eMax 2/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 2.5 A, 250 V. Item to be replaced by Synthes Anspach repair facility ONLY.

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Synthes

Anspach Electric Systems

Instructions for Use

Console Indicators Code

Description

Audible Signal*

Corrective Action

E1, E8

System Fault

None

Turn Power switch to off, and then back on. If fault does not clear, return console and handpiece to Synthes Anspach for service.

E2

Handpiece Lock Engaged

10 slow beeps

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

E3

Handpiece Stall Warning

10 fast beeps

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

E4, E5

Fault in Handpiece

None

Return console and handpiece to Synthes Anspach for service

E6, E7

Handpiece overheat warning, impending handpiece shutdown

5 second beep

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.

E9

Handpiece type not recognized

None

Disconnect connector and reconnect to console. If fault does not clear, return handpiece and console to Synthes Anspach for service.

None

Handpiece set to reverse

3 beeps

*Note: Consoles with Software Version 3.0 and higher do not generate an Audible Signal for Codes E1– E9.

Anspach Electric Systems

Instructions for Use

Synthes

19