Synthes Anspach User manual

High Speed
Power Tools
Anspach Electric Systems. High speed
performance and power in a variety of
applications.
Instructions for Use
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Anspach Electric Systems Instructions for Use Synthes 1
Table of Contents
Introduction
Operating Instructions
Attachments and Dissection Tool Assembly
Care and Maintenance
Synthes Anspach 2
High Speed Electric Systems 2
Indications 3
Warnings and Cautions 4
Technical Specifications 5
lossary 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
Micro Curved Attachment (MCA) and 29
Curved Burr Support Sleeves (Curved Burr)
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
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2 Synthes Anspach Electric Systems Instructions for Use
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 ad-
vanced design of these instruments provides performance
and reliability, they also allow for effortless assembly, meet-
ing the needs of both surgeon and staff for the most de-
manding applications. No tools are required to assemble dis-
section tools or attachments.
All Synthes Anspach instruments are manufactured to con-
form 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.
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 sur-
gical 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 opti-
mum balance of power, smooth operation, and ergonomic
comfort. The eMax 2 and eMax 2 Plus System Consoles pro-
vide 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 ex-
change of Synthes Anspach microSaw attachments and small
attachments (J-Latch and Jacobs Chuck) resulting in a com-
plete range of attachments and tools for all of your small
bone procedures.
eMax 2 Plus e12
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Indications
Anspach Electric Systems Instructions for Use Synthes 3
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 Hand-
piece 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. Neurosurgery and ENTSpine surgery
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Warnings and Cautions
4 Synthes Anspach Electric Systems Instructions for Use
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.
Do not use if the product sterilization barrier or its packaging
is compromised.
Do not use, or discontinue use of powered equipment ex-
hibiting 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.
Confirm attachment is proper size for dissection tool and
that it is secure.
ently 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 thor-
oughly protected to prevent injury.
Irrigation is necessary for proper operation.
Maintain firm 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.
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 flammable environment.
Do not modify ground or power cord.
Do not allow liquid into console.
Portable and Mobile RF communications equipment can af-
fect Medical Electrical Equipment.
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.
Do not use in oxygen rich environment.
Do not modify. Modifications could result in 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. Irrigation Tubes contain DEHP
a type of phthalate.
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.
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 Synthes
Anspach and specified for use with Anspach systems.
Use care to protect hose when handling, cleaning, and dur-
ing 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.
To ensure 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.
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Technical Specifications
Anspach Electric Systems Instructions for Use Synthes 5
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 cm214.6 cm232.7 cm
(12.25 in25.74 in212.87 in)
Weight: 6.25 kg (13.77 lbs)
The device complies with the following standards:
IEC 60601-1/IEC 60601-1-2
With regard to electrical shock, fire, mechanical hazards, this
device is certified to UL 60601-1 and CAN/CSA C22.2
No. 601.1
This device complies with applicable EEC directives.
Foot Pedal (E-FP, E-FP-DIR, E-FP-DIR/IRR) Specifications
Size: 26.7 cm216.5 cm214.7 cm
(10.5 in26.5 in28.5 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.
Additional Information
To isolate the device from the mains supply, remove the
power cord. All specifications are subject to change.
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Technical Specifications
6 Synthes Anspach Electric Systems Instructions for Use
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
roup 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 The Synthes Anspach High Speed Electric System is suitable for use in all
establish ments, 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 fluctuations/
flicker emissions
IEC 61000-3-3
Complies
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Anspach Electric Systems Instructions for Use Synthes 7
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
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete or ceramic tile.
If floors are covered with synthetic material,
the relative humidity should be at least 30%
Electrical fast
transient/burst
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 inter-
ruptions and
voltage variations
on power supply lines
IEC 61000-4-11
<5% UT(0.5 cycle)
40% UT(5 cycles)
70% UT(25 cycles)
<5% UTfor 5s
<5% UT(0.5 cycle)
40% UT(5 cycles)
70% UT(25 cycles)
<5% UTfor 5s
Mains power quality should be that of a typical
commercial or hospital environment.
ote: UTis 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.
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Technical Specifications
8 Synthes Anspach Electric Systems Instructions for Use
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
3 V 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 sep-
aration 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 Hz
Where Pis the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation distance
in metres (m).
Field strengths from fixed RF transmitters, as determined by
an electromagnetic site survey,ashould be less than the com-
pliance 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 Hz
3 V/m
ote 1: At 80 MHz and 800 MHz, the higher frequency range applies.
ote 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
aField 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.
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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Anspach Electric Systems Instructions for Use Synthes 9
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 out-
put 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 √P
80 MHz to 800 MHz
d = 1.2 √P
800 MHz to 2.5 Hz
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 Pis the maximum output power
rating of the transmitter in watts (W) according to the transmitter manufacturer.
ote 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
ote 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
ote 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.
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CUTTER
RUN
ADJUST
TUBE
SAFE
F
F
R
Glossary of Symbols
10 Synthes Anspach Electric Systems Instructions for Use
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
Located on the Handpiece this indicates
position of the knurled knob to the desired
location
Symbol with yellow background: CAUTION:
Refer to accompanying documentation
AC Power Source
Consult Operating Instructions
Located on the Console this indicates
Motor or Handpiece unit
Located on the Console this indicates
Foot Control activation
Located on the Console this indicates
Hand Control activation
Located on the Console this indicates
Forward (Clockwise rotation when looking at
Handpiece from proximal end)
Located on the Console this indicates Reverse
(Counterclockwise rotation when looking at
Handpiece from proximal end)
Revolution per Minute
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
30 Sec ON / Duty Cycle of the e12 system and DRIVER
30 Sec OFF
Company Logo
Direction of rotation
Direction of rotation for lock position
Indicates setting, position, or location
Indicates setting, position, or location
Indicates the drill tip exposure
Indicates the attachment setting, refer to
MA-D20 and MA-DRIVER section in this
document for further details
Indicates position or location
Indicates position or location
Indicates action of rotation and position for
Secure (LOCK) and Release (UNLOCK)
Direction of rotation
Direction of rotation for lock position
Direction of rotation
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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00/0000
0
0
.
.
5
5
3
3
.
.
2
2
4
4
.
.
8
8
6
6
.
.
4
4
8
8
.
.
0
0
2
2
.
.
4
4
1
1
.
.
6
6
Located on the Console this indicates a
change of rotational speed rate for the
Handpiece
Temperature Limits
Equipotential post location
Found on the Console ON/ OFF
Located on the Console Irrigation Pump this
indicates a possible finger pinch point
Located on the Console Irrigation
Pump these symbols are not used
by the user since the pump is self
adjusting to the Irrigation Tube di-
ameter
Reference Number (A.K.A. Item Number,
Catalog Number, Part Number)
Lot (A.K.A. Lot Number, Batch Number,
Batch Code)
Serial Number
Use By Date (A.K.A. Expiration Date, Expiry)
Manufacturer
Authorized European Union Representative
Sterilized Using Irradiation
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
United States Federal law restricts this device
to sale by or on the order of a physician or
other licensed health-care provider
CE Mark (A.K.A. CE Mark [notified body
number], Conformité Européenne)
Meaning: Device complies with applicable
EEC Directives
Lock (Run)
Unlock (Load)
Transmitter
Interference may occur in the vicinity of
equipment marked with this symbol.
Type B Electrical Equipment
Product warranty is void if seal is damaged
or removed.
Instrument System Key
eMax 2 and eMax 2 Plus
e12
Latex-free Certification
There is no latex material in Synthes Anspach products or
packaging.
EM
E12
Anspach Electric Systems Instructions for Use Synthes 11
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Consoles Foot Control
Features Hand Controls
SC2000 SC2000U
SC2100
SC2101
SC2102
Active Direction Control Switch
Active Irrigation Control Switch
EMAX2-HC
E12-HC
E-HC
Foot Controls
E-FP • • • • •
E-FP-DIR • • • • • •
E-FP-DIR/IRR • • • • • • •
EMAX2-FP • • • • • • •
EPLUS-FP • • • • • • •
EMAX2-FP-NS • • • • •
EPLUS-FP-NS • • • • •
Accessories
E-SA ITTAL** • • • • •
E12** • • • • • •
Handpieces
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.
**”Port” LED on console face panel does not illuminate when this accessory is
connected to console.
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.
The eMax 2 and eMax 2 Plus High Speed Handpieces oper-
ate continuously at speeds up to 80,000 rpm.
Power Switch
Handpiece
Connector Port Foot Control
Connector Port
Face Panel
Back of System Console
Handpiece Housing
Knurled Knob
Attachment Connection Swivel (270°)
Handpiece Hose
Protective
Cap
ote: 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.
Handpiece Hose Connector
Power Switch
IV Pole
Mount
AC Power Inlet*
12 Synthes Anspach Electric Systems Instructions for Use
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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 rade grounded
wall outlet. Connect to supply mains with protective earth
only.
2. Insert foot control cord connector into Foot Control 1 con-
nector port. (A second foot control cord may be con-
nected 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 connec-
tor port when out of alignment.
3. Plug handpiece hose connector into Handpiece 1 connec-
tor 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 Opera-
tion and Foot Control Operation below.
ote: Handpiece is fully functional at this time.
Anspach Electric Systems Instructions for Use Synthes 13
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eMax 2 and eMax 2 Plus Operating Instructions
ote: 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 de-
tectable by feel.
Irrigation
Increase/Decrease Irrigation ON/OFF
Foot Control
LED: Foot
Control #2
LED: Foot
Control #1
Hand Control
R: Reverse
F: Forward
LED: Reverse
LED: Forward
H Decrease Speed
GIncrease Speed
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.
14 Synthes Anspach Electric Systems Instructions for Use
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E-FP-DIR Foot Control
Directional
Control
Switch
E-FP Foot Control
Irrigation
Control
Switch
Directional
Control
Switch
EMAX2-FP or EMAX2PLUS-FP Foot Control
Foot Control Operation
Certain optional foot controls have direction and irrigation
control switches.
1. See Step 2 of Console Face Panel Operation to set opera-
tional 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.
ote: 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 re-
lease pressure on pedal to decrease speed of handpiece.
4. Optional: To change direction of handpiece, depress Direc-
tional 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 in-
dicates 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.
Anspach Electric Systems Instructions for Use Synthes 15
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eMax 2 and eMax 2 Plus Operating Instructions
eMax2-HC
Insert to Lock
Notch lines up
with Dimple
Dimple
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 lay-
ing 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.
ote: 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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Irrigation
(Activate and Deactivate)
Decrease Flow
LED: Irrigation
Flow Rate
Increase Flow
Irrigation Pump
Release Button
Irrigation Pump
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 Tubing Set-up
IRRI ATE-TUBE Sterile Tubing and Hoseclips
for Irrigation System
IRRI ATE-TUBE-HF Sterile High Flow Tubing and Hoseclips
for Irrigation System
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
attach ment clip.
2. Attach irrigation attachment clip to handpiece.
3. Secure tubing to handpiece hose using Hose Clips, which
are included with tubing.
‚
„
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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 por-
tion of connector between thumb and forefinger of one
hand. ently 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.
Caution:
– Do not sterilize, and do not allow liquid into pump.
– Do not operate with pumphead open.
– Do not use eMax 2 or eMax 2 Plus with MS-OSC or
MS-SA . Attempting to do so will result in damage to the
saws and possible damage to the eMax 2 and eMax 2 Plus
Motors.
Warning:
– Irrigation tubing, attachment clip, and hose clip are for
SIN LE 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.
– The eMax 2 and eMax 2 Plus Systems are Medical Electri-
cal Equipment, requiring special precautions related to
EMC, and for this reason must be put into service as de-
scribed in this product manual.
– 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. rounding reliability can only be
achieved when this equipment is connected to a recepta-
cle marked “HOSPITAL RADE.”
ote: 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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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 10 slow beeps Rotate the knurled knob on handpiece clockwise to ensure the
Engaged handpiece is not locked.
E3 Handpiece Stall 10 fast beeps Remove pressure from foot control (or hand control),
Warning 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 5 second beep Reduce or remove load from handpiece to allow handpiece to
warning, impending cool. If load is not reduced sufficiently, handpiece will shut down
handpiece shutdown 30 seconds after tone is heard and/or code is displayed.
E9 Handpiece type None Disconnect connector and reconnect to console. If fault does not
not recognized clear, return handpiece and console to Synthes Anspach for service.
None Handpiece set 3 beeps
to reverse
*ote: 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
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