Anspach eMax 2 User manual

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English
eMax 2 and eMax 2 Plus
High Speed Electric Systems

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Contents
General Information..........................................................2
System Assembly .............................................................6
System Operation.............................................................6
System Shutdown.............................................................8
Additional Information.......................................................8
Console Alerts, Codes, and Displays ...............................8
Trouble Shooting ..............................................................9
Technical Specications .................................................10

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General Information
System Description
High Speed Electric Drill System consisting of consoles, handpieces, foot controls, hand controls, an assortment of
attachments and dissection tools and irrigation accessories.
Indications for Use
Cutting and shaping bone including bones of the cranium and spine.
Contraindications
None.
Cleaning and Sterilization
•Prior to rst use the equipment must be processed as per the included Anspach 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 Cleaning and Sterilization instructions accompanying this device.
Features & Compatibility
Consoles Foot Control
Features Hand Controls
SC2100 SC2101 SC2102
Active Direction
Control Switch
Active Irrigation
Control Switch
EMAX2-HC
E-HC
Foot Controls
E-FP • • •
E-FP-DIR • • • •
E-FP-DIR/IRR • • • • •
EPLUS-FP • • • • •
EPLUS-FP-NS •••
Hand-
pieces
EMAX2PLUS • • • • •
EMAX2 • • • • •
Console
Features
Two Foot Control Ports * •
Two Handpiece Ports * •
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.
The following instructions are written such that the handpiece and attachments are held with distal end pointed away from
user.
Symbols
Anspach Product Icon Consult Operating Instructions
Located on the Foot Pedal switch this indicates
a change state (on/off) for the console Irrigation
System
Located on the Foot Pedal switch this indicates
a change of rotational direction for the
handpiece
Direction of rotation Keep Dry (A.K.A. Protect from Moisture)
Direction of rotation for lock position Indicates position, alignment or location
Indicates setting, position or location AC Power Source
Indicates setting, position or location Indicates position or location
Indicates the attachment setting, refer to MA-
DRIVER & MA-D20 section in this document for
further details
Located on the Console this indicates motor or
handpiece connector

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Symbols
Indicates the drill tip exposure Symbol with yellow background: CAUTION:
refer to accompanying documentation
Located on the Console this indicates Hand
Control activation
Located on the Console this indicates Foot
Control connector
Duty Cycle of the DRIVER Revolution per Minute
Located on the Console this indicates Forward
(Clockwise rotation when looking at handpiece
from proximal end).
Located on the Console this indicates Reverse
(Counter-Clockwise rotation when looking at the
handpiece from proximal end)
Indicates action of rotation and position for
Secure (LOCK) and Release (UNLOCK)
Located on the Console this indicates a change
of irrigation state for the Console Irrigation
System
Direction of rotation Direction of rotation
Direction of rotation for lock position
1. Console Control Touch pad: indicates a
change state (on/off) for the Console Irrigation
System
2. Irrigation Pump: Indicates irrigation tube
direction towards the irrigation source
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
of rotational speed rate for the Handpiece
NO NOT DISPOSE OF IN HOUSEHOLD
WASTE
Temperature Limits Sterile unless damaged or open
0086
CE Mark (A.K.A. CE Mark [Notied body
number], Conformité Européenne)
Meaning: Device complies with applicable EEC
Directives
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 in the Console Irrigation Pump this
indicates a possible nger pinch point
Lock (Run) Unlock (Load)
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
Located on the Handpiece this indicates
position of the knurl knob to the desired location
Reference Number (A.K.A> Item Number,
Catalogue Number, Part Number) Serial Number
Lot (A.K.A. Lot Number, Batch Number,
Batch Code)
Transmitter Interference may occur in the
vicinity of equipment marked with this symbol.
Manufacturer Type B Electrical Equipment
00/0000 Use By Date (A.K.A. Expiration Date, Expiry) Product warranty is void if seal is damaged
or removed.
Authorized European Union Representative Single Use Only (A.K.A. Do Not Reuse)
Sterilized Using Irradiation CAUTION: Refer to accompanying
documentation
Date of Manufacture Global Trade Item Number (GTIN)
Batch or Lot Number Expiration Date (YYMMDD)
Serial Number Quantity
Global Trade Item Number Indicates Environmental Friendly Use Period of
50 years in China.
Indicates Environmental Friendly Use Period of
10 years in China.
Indicates Environmental Friendly Use Period
in China, this product does not contain any
hazardous substances exceeding concentration
limits.

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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 handling dissection tools.
• Dissection tools must be adequately retained within attachment to prevent distal migration, which may cause injury.
Conrm 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 intensier is utilized.
•Delicate structures in proximity to dissection must be thoroughly protected to prevent injury.
• Maintain rm control of instrument at all times.
•Do not bend or use as a lever.
•Use a gentle tapping motion or side-to-side motion and let instrument do cutting.
•Do not use excessive force.
•Forceful side loading of dissection tool may cause fracture of dissection tool, which may cause injury.
• Dissection tools are disposable and intended for single patient use only. Do not re-sterilize and/or re-use dissection tools.
Reuse and/or re-sterilization of these devices could result in reduced performance, material degradation and/or patient
contamination
•Use standard protocol for disposal of sharp instruments.
• Continuous extreme cutting at or near stalling conditions will quickly overheat handpiece.
• Do not operate in an explosive ammable environment.
•Do not modify ground or power cord.
• Do not allow liquid into console.
•Do not use a craniotome in conjunction with Hand Control. Excessive rotational force on hand control may move it, thus
shutting handpiece down.
• Use of accessories or cables other than those provided by DePuy Synthes Power Tools and specied for use with the
eMax 2 or eMax 2 Plus System may result in increased emissions or decreased immunity.
• The eMax 2 or eMax 2 Plus should not be used adjacent to or stacked with other equipment and that if adjacent or stacked
use is necessary, the eMax 2 or eMax 2 Plus should be observed to verify normal operation in the conguration in which it
will be used.
• Medical Electrical Equipment needs special precautions regarding 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.
• 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 modication of this equipment is allowed.
• Do not modify. Modications could result in loss of electrical safety.
• Dispose of items contaminated with body uids with other biohazardous waste.
•At end of life recycle or dispose of device in accordance with local and national regulations.
• To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. The
use of Accessories, transducers, and cables other than those specied, 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 eMax 2 or eMax 2 Plus System.

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Cautions
•United States Federal law restricts this device to sale by or on order of a physician or other licensed healthcare provider.
•Do not use accessories other than those provided by DePuy Synthes Power Tools and specied for use with Anspach
Systems.
•To insure equipment operates as designed, read and follow manufacturer’s instructions.
•Do not operate handpiece without an attachment and the corresponding dissection tool.
•Do not engage safety mechanism while handpiece is running; doing so makes safety mechanism inoperable.
•Only Anspach Dissection Tools should be used with eMax 2 or eMax 2 Plus Systems.
•Use care to protect hose when handling, cleaning, and during system use.
•Damage to hose can cause leaking, rupture, or other related failures.
•Do not step on, set equipment on, pinch, kink, clamp, or otherwise occlude handpiece hose during use.
•Do not engage safety mechanism while handpiece is running; doing so makes safety mechanism inoperable.
•Do not use eMax 2 / eMax 2 Plus System with MS-OSC or MS-SAG; attempting to do so will result in damage to saws
and possible damage to eMax 2 / eMax 2 Plus Handpiece.
Latex Information
Not made with natural rubber latex.
Warranty & Return Policies
Warranty and return policy is available upon request.
Warning: All Instrument System components returned for servicing or repair should be properly cleaned and sterilized as
applicable prior to shipping.
Warning: Transmissible Spongiform Encephalopathies (TSE)
DePuy Synthes Power Tools will not authorize or accept the return of products that directly contact patients or are
contaminated with a patient’s body uids who is suspected or conrmed with a Transmissible Spongiform Encephalopathies/
Creutzfeldt-Jakob Disease (TSE/CJD) diagnosis. DePuy Synthes Power Tools recommends that all Anspach products used
on a patient conrmed with a TSE/CJD diagnosis be incinerated. Anspach Dissection Tools used on a patient suspected of
TSE/CJD diagnosis must be incinerated.
Contact your Sales Representative for replacement of product incinerated under this policy or for temporary equipment
while original equipment is quarantined. Contact the DePuy Synthes Power Tools Customer Service Department regarding
TSE/CJD contamination for additional information.

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System Assembly
Warning
Prior to rst use the equipment must be processed as per the included Anspach High Speed System Cleaning and
Sterilization instructions.
Note: When following these instructions hold handpiece and attachments with distal end pointing away from user.
1. 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. 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 connector 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
may 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 back of console to “I” position. Appropriate face panel light
emitting diodes (LED) illuminate and a beep will sound.
5. For operating instructions see Console Face Panel Operation and Foot Control Operation below.
Note: Handpiece is fully functional at this time.
Irrigation Assembly for Consoles with Optional Irrigation (Excludes SC2102)
1. Upon startup “Irrigation” is OFF, and LED is not illuminated.
2. Insert IV pole into bracket on back of console.
3. Hang irrigation bag onto IV pole.
4. Check integrity of irrigation tubing package and use by date.
Warning: Discard product if sterilization barrier or its packaging is compromised or if past its expiration date.
5. Remove tubing and hose clips from package.
6. Connect small diameter tubing to proximal end of attachment clip.
7. Secure clip to handpiece and attachment.
8. Route tubing along handpiece hose and secure to hose using hose clips.
9. Remove protective cap from bayonet and insert bayonet into irrigation bag.
10. Hold irrigation bag and tubing vertical and allow uid to completely ll large diameter tubing.
11. Depress button located on right side of console to eject pump head.
12. Lift top of pump head and insert large diameter section of tubing into pump. Refer to diagram on pump housing to
ensure tubing is routed properly (smaller diameter tubing ows towards Anspach Handpiece).
Note: Verify there are no air bubbles between irrigation bag and pump. If air bubbles are present, remove tubing from pump
and allow uid to completely ll large diameter tubing and reinstall to pump.
13. Check position of tube in pump to avoid damage to irrigation tubing and close pump head.
14. To activate, depress “Irrigation” button on face panel. LED illuminates.
15. To control ow of irrigation, depress arrows located to right of irrigation button on face panel.
Note: Irrigation can also be activated from certain optional Foot Controls (see Step 5 of Foot Control Operation).
16. Depress Irrigation Control Switch on top right of foot control. Upon activation, LED on face panel illuminates.
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. Do not operate with pump head open.
Warning: Irrigation tubing, attachment clip, and hose clip are SINGLE USE ONLY. Reuse and/or re-sterilization of these
devices could result in reduced performance, material degradation and/or patient contamination. For proper operation only
use at ambient temperatures between 65°F to 85°F (18°C to 29°C).
System Operation
Upon startup, console is set to operate handpiece in forward (clockwise when viewed from proximal end of 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.
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 ow of irrigation,
depress arrows located to right of irrigation button on face panel.

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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.
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.
Hand Control Assembly and Operation
Optional hand-control attachment for handpiece allows user to control operation with a lever attached to handpiece.
Warning: Do not expose handpiece to magnets (such as laying handpiece on magnetic drapes) when in hand control
mode, as handpiece operation may occur.
Warning: 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.
System Operational Assessment
1. Conrm attachment and dissection tools are properly locked in place.
2. Depress foot pedal to assure you have properly functioning device prior to proceeding.
3. Conrm device functions as expected. If device does not function as expected refer to troubleshooting chart.
Prior to Use Inspection
Straight Attachments Visually inspect for any damage to the tube.
Angle Attachments Visually inspect for bent or broken drive shaft and for any damage to the tube.
Craniotomes Visually inspect for bent or broken foot.
Perforator Driver Visually inspect for overall damage or missing components.
Foot Pedals Visually inspect for damage to the electrical cord or connector.
Visually inspect for damage or cracks to the housing or pedal.
EMAX2
EMAX2PLUS
Visually inspect for damage to the silicone hose or to the electrical connector.
Connect to console and operate.
The handpiece should operate smoothly.
There is no requirement to operate with attachment or dissection tool.
SC2100
SC2101
SC2102
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.
NOTE: DRIVER Duty Cycle 30 Sec ON, 30 Sec OFF for eight cycles.
The recommendations for times of use for the DRIVER attachments have been determined under average load and worst
case ambient air temperature of 85°F (29°C).

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System Shutdown
1. There are no special procedures for system shutdown. Depress power switch on rear of console to shut down system.
2. To disconnect power cord from mains, grasp ridged portion of connector between thumb and forenger 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
End of Life
Return all equipment for proper disposal.
Recommended Manufacturer Service Interval
It is recommended that the equipment be returned to DePuy Synthes Power Tools at a minimum every 9 months for full
product inspection and service.
Console Alerts, Codes, and Displays
Console Indicators
Code Description Audible Signal **
E1, E8 * System Fault none
E2 Handpiece Lock Engaged 10 slow beeps
E3 Handpiece Stall Warning 10 fast beeps
E4, E5 * Fault in Handpiece none
E6, E7 Handpiece Overheat Warning 5 second beep
E9 * Handpiece Not Recognized none
(none) Handpiece Set to Reverse 3 beeps
* If these codes are displayed, return handpiece and console to DePuy Synthes Power Tools for servicing.
** 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 non-irrigation console models, the buttons can be found in the same
location, although they are not marked.

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Trouble Shooting
Trouble Shooting Chart
Problem Possible Cause Possible Solution
Excessive handpiece
noise. 1. Faulty internal component. 1. Return attachment to DePuy Synthes Power Tools for service.
Lack of power to
console. 1. Plug is not fully inserted/power switch not turned on.
2. Outlet is not functional.
1. Verify plugs to wall and back of console are
pushed in completely.
2. Verify another piece of electrical equipment
can receive power from outlet.
Handpiece vibration
or extremely hot. 1. Faulty internal component. 2. Internal motor overheats due to continuous
extreme cutting at near stalling conditions.
3. Hose may be kinked.
4. Handpiece out of balance.
5. Handpiece hose damaged.
1. Return to DePuy Synthes Power Tools for
service.
2. Decrease cutting force, allow motor to cool.
3. Unkink hose (verify it is not being pinched
or clamped to table).
4. Return to DePuy Synthes Power Tools for
service.
5. Return to DePuy Synthes Power Tools for
service.
Excessive vibration
of dissection tool. 1. Dissection tool may be bent. 2. Dissection tool may not be fully seated.
3. Improper attachment and dissection tool
combination.
4. Possible attachment bearing damage.
1. Replace with new dissection tool.
2. Reassemble dissection tool and attachment.
3. Only use correct dissection tool with
appropriate attachment.
4. Return to DePuy Synthes Power Tools for
service.
Attachment is hot. 1. Debris lodged inside attachment.
2. Possible bearing damage. 1. Clean attachment using Anspach Attachment Cleaning Instructions.
2. Return attachment to DePuy Synthes
Power Tools for service.
Craniotome
attachment is bent. 1. Excessive force used in operation. 1. Do not use, replace attachment.
Inoperative Foot
Control (LEDs are
illuminated on face
panel)
1. Selected foot control on face panel does not
match foot control in use
2. System is set in hand control mode (LED
light is illuminated)
3. Plug may not be fully inserted
4. Handpiece in “Safe” position or cutter is
not rotating
5. Defective attachment
1. Press Foot Control button on face panel to
select other Foot Control
2. Press Foot Control button on face panel
to set it for Foot Control 1 or 2, depending
which one is in use.
3. Verify plug for handpiece and foot control
are fully inserted. Plug will latch in place
once fully inserted.
4. Verify cutting burr is completely engaged
and handpiece’s knurled knob is in secure
position.
5. Clean attachment or replace attachment.
Inoperative Hand
Control 1. Defective internal component 2. Hand Control may not be fully installed.
3. Selected Hand Control on face panel not
in use.
4. Internal handpiece switch activating Hand
Control may be damaged.
1. Return hand control to DePuy Synthes
Power Tools for service.
2. The circumferential groove on handpiece
housing will be exposed when the Hand
Control is fully installed.
3. Press Hand Control button on face panel to
illuminate Hand Control LED
4. Return handpiece to DePuy Synthes Power
Tools for service.

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Technical Specications
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 equipment part 1: General requirements for basic safety and
essential performance;
UL 60601-1:2003 (Revised 2006), IEC 601-1:1988 +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, re, mechanical hazards, this ETL classied device conforms to AAMI STD ES60601-1, UL
STD 60601-1, and is certied to CSA STD C22.2 No.60601-1 and 601.1
This device complies with applicable EEC directives. Medical Device Directive 93/42/EEC as amended by 2007/47/EC.
Machinery Directive 2006/46/EC.
Environmental Conditions
Temperature Operating: 18°-30°C (65°-85°F)
Transportation and Storage: -29° – +50°C (-20° - +120°F)
Relative Humidity Operating: 30% to 70%
Transportation and Storage: 10% to 90%
Atmospheric
Pressure
Operating: 0.7–1.06bar
Transportation and Storage: Not applicable
Console (SC2100, SC2101, and SC2102) Specications
Primary: 100-240VAC, 50/60 Hz, 250 VA
Class I: Protective Earth
Fluid Ingress Protection: IPX0
Type B: Applied Part, Continuous Operation
Foot Pedal (E-FP, E-FP-DIR, E-FP-DIR/IRR) Specications
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 (4.41 lbs)
Cord: 3.66 m (12 ft) in length
Fluid Ingress Protection: IPX8

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Table 1: Emission
The Anspach High Speed Electric System is composed of the eMax 2 and eMax 2 Plus Handpiece models: EMAX2 and
EMAX2PLUS; Electric Consoles models SC2100, SC2101, & 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.
Guidance and manufacturer’s declaration –
electromagnetic emissions
The Anspach High Speed Electric System is intended for use in the electromagnetic environment specied 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
CISPR 11 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. RF emissions.
RF emissions
CISPR 11 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.
Harmonic emissions
IEC 61000-3-2 Class A
Voltage uctuations / icker emissions
IEC 61000-3-3 Complies
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 specied below. The
customer or the user of 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
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete or
ceramic tile. If oors 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
(>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
<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
Mains power quality should be that
of a typical commercial or hospital
environment.
Note: UTis the a.c. mains voltage prior to application of the test level.
Power frequency (50/60
Hz) magnetic eld
IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic elds should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.

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English
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 specied 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
IEC 61000-4-6
3 Vrms
150 kHz to
80 MHz
3 Vrms
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.
Recommended separation distance
d = 1.2
d = 1.2 80 MHz to 800 MHz
d = 2.3 800 MHz to 2.7 GHz
Where Pis the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and dis the
recommended separation distance in metres
(m).
Field strengths from xed 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:
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to
2.5 GHz
3 V/m
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
reection from structures, objects and people.
a Field strengths from xed 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 xed RF transmitters, an electromagnetic site survey
should be considered. If the measured eld 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
should be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the device containing the Anspach High Speed Electric System.
b Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.

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English
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
W
Separation distance according to frequency of transmitter
150 kHz to
80 MHz
d = 1.2
80 MHz to
800 MHz
d = 1.2
800 MHz to
2.5 GHz
d = 2.3
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 din metres (m)
can be estimated using the equation applicable to the frequency of the transmitter, where Pis 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
reection from structures, objects and people.

15
Deutsch
eMax 2- und eMax
2-Plus elektrische
Hochgeschwindigkeitssysteme

17
Deutsch
Inhaltsverzeichnis
Allgemeine Informationen...............................................18
Systemmontage..............................................................22
Systembetrieb.................................................................23
Systemabschaltung ........................................................25
Weitere Informationen ....................................................25
Alarme, Codes und Displays der Konsole......................25
Fehlerbehebung .............................................................26
Technische Daten...........................................................27

18
Deutsch-German
Allgemeine Informationen
Systembeschreibung
Elektrisches Hochgeschwindigkeits-Bohrersystem, das aus Konsolen, Handstücken, Fuß- und Handbedienungen, einer
Reihe von Aufsätzen und Sezierinstrumenten sowie Spülzubehör besteht.
Indikationen
Schneiden und Formen von Knochen, einschließlich Knochen im Schädel- und Wirbelsäulenbereich.
Kontraindikationen
Keine.
Reinigung und Sterilisation
•Die Geräte sind vor der ersten Verwendung gemäß den beiliegenden Anweisungen zur Reinigung und Sterilisation von
Anspach aufzubereiten.
•Am Einsatzort ist das Gerät sobald wie möglich nach der Verwendung zu reinigen, damit Blut, Gewebe, sonstigen
biologischen Rückständen und Kontaminanten nicht auf dem Gerät antrocknen.
•Dazu die diesem Gerät beiliegenden Anweisungen zur Reinigung und Sterilisation von Anspach hinzuziehen.
Leistungsmerkmale und Kompatibilität
Konsolen Leistungsmerkmale der
Fußbedienung Handbedienungen
SC2100 SC2101 SC2102
Aktiver Schalter
für die
Richtungssteuerung
Aktiver Schalter für
die Spülsteuerung
EMAX2-HC
E-HC
Fußbedienungen
E-FP • • •
E-FP-DIR • • • •
E-FP-DIR/IRR • • • • •
EPLUS-FP • • • • •
EPLUS-FP-NS • • •
Handstücke
EMAX2PLUS • • • • •
EMAX2 • • • • •
Leistungsmerkmale
der Konsole
Zwei Buchsen für Fußbedienungen * •
Zwei Buchsen für Handstücke * •
Spülkonsole • •
* Sind beim Hochfahren der Konsole zwei Fußbedienungen oder zwei Handstücke angeschlossen, wird standardmäßig
Fußbedienung 1 und/oder Handstück 1 eingeschaltet.
Die nachfolgenden Anweisungen wurden unter der Vorgabe abgefasst, dass das distale Ende von Handstück und Aufsätzen
vom Benutzer wegzeigt.
Symbole
Anspach Produktsymbol Gebrauchsanweisung hinzuziehen
Symbol auf dem Schalter des Pedals, zeigt eine
Statusänderung (Ein/Aus) des Spülsystems der
Konsole an
Symbol auf dem Schalter des Pedals, zeigt einen
Wechsel der Drehrichtung des
Handstücks an
Drehrichtung Trocken lagern (auch: Vor Feuchtigkeit schützen)
Drehrichtung für Sperrposition Zeigt Position, Ausrichtung oder Stellung an
Zeigt Einstellung, Position oder Stellung an Wechselstromquelle
Zeigt Einstellung, Position oder Stellung an Zeigt Position oder Stellung an