Location via proxy:   [ UP ]  
[Report a bug]   [Manage cookies]                

Emax 2 Plus System: User'S Manual

Download as pdf or txt
Download as pdf or txt
You are on page 1of 60

EMAX® 2 PLUS

SYSTEM
High speed performance and power
in a variety of applications

This publication is not intended for distribution in the USA.

USER’S MANUAL
TABLE OF CONTENTS

INTRODUCTION Anspach Electric System 2

Indications and Contraindications 3

Warnings and Cautions 4

Technical Specifications 5

Glossary of Symbols 10

OPERATING INSTRUCTIONS eMax 2 Plus Operating Instructions 12

ATTACHMENTS AND DISSECTION TOOL ASSEMBLY Standard Attachments and Dissection Tool Assembly 20

Otologic Curved Micro (OCM) Attachment and


Otologic Curved Micro (OCM) Burr Support Sleeves 25

Minimal Access Attachment and Dissection


Tool Assembly 26

microSaws and Small Attachments Assembly 28

Perforator Driver 31

CARE AND MAINTENANCE Inspection and Maintenance 32

Cleaning Instructions 36

Manual Cleaning 37

Manual Pre-Cleaning Before


Mechanical /Automated Cleaning 41

Mechanical / Automated Cleaning


Following Manual Pre-Cleaning 47

Lubrication49

Sterilization50

Loading Configuration 52

Troubleshooting53

Ordering Information 54
Image intensifier control

Anspach eMax 2 Plus System  User’s Manual   DePuy Synthes Companies    1


ANSPACH ELECTRIC SYSTEM

HIGH SPEED PERFORMANCE AND


POWER IN A VARIETY OF APPLICATIONS
DePuy Synthes Power Tools
DePuy Synthes Power Tools manufactures pneumatic
and electric high speed performance instruments and at-
tachments 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 ef-
fortless assembly, meeting the needs of both surgeon
and staff for the most demanding applications. No tools
are required to assemble dissection tools or attachments.

All DePuy Synthes Power Tools instruments are manufac-


tured to conform to rigorous quality standards to provide
dependable performance. eMax 2 Plus

EMAX 2 Plus System


The EMAX 2 Plus System operates up to 80,000 rpm. It
offers variable speed, bi-directional operation, minimal
noise levels, and an optional hand control. It is a high
performance system that highlights minimal vibration
performance, thermal energy management, and high re-
liability for neurosurgeons, otologists, neurotologists,
skull base surgeons, and spinal surgeons.

Warning: Before using any of the Anspach High


Speed Electric Systems, it is imperative that all indi-
viduals working with the system read this operating
manual. The surgeon is responsible for learning the Spine surgery Neurosurgery and
Otologic surgery
proper techniques in the use of this system, as im-
proper use may cause injury.

If you have any questions after reading this manual,


please contact your Depuy Synthes Sales Representative.

2    DePuy Synthes Companies  Anspach eMax 2 Plus System  User’s Manual


INDICATIONS AND CONTRAINDICATIONS

Indications
The Anspach eMax 2 Plus High Speed Electric System is
intended for cutting and shaping bone including spine
and cranium.

The Anspach eMax 2 Plus High Speed Electric System


is composed of the eMax2Plus Handpiece model; Electric
Consoles models SC2100, SC2101, and SC2102; Foot
Control models E-FP, E-FP-DIR, E-FP-DIR/IRR, EPLUS-FP,
EPLUS-FP-NS; Hand Controls EMAX2-HC and E-HC.

Contraindications
None.

Anspach eMax 2 Plus System User’s Manual DePuy Synthes Companies 1


WARNINGS AND CAUTIONS

Warnings Use a gentle tapping motion or side-to-side motion and


Irrigation is necessary for proper operation. let instrument do cutting.

Surgeon is responsible for learning proper techniques in Do not use excessive force.
use of equipment; improper use may cause serious injury Forceful side loading of dissection tool may cause frac-
to user or patient or damage to system. ture of dissection tool, which may cause injury.
Instrument operator and all operating room personnel Dissection tools are disposable and intended for single
must wear eye protection. patient use only. Do not resterilize and / or reuse dissec-
Visually inspect for damage before using; do not use tion tools.
if damage is evident. Use standard protocol for disposal of sharp instruments.
Do not use if the product sterilization barrier or its Continuous extreme cutting at or near stalling conditions
packaging is compromised. will quickly overheat handpiece.
Do not use, or discontinue use of powered equipment Do not operate in an explosive flammable environment.
exhibiting excessive temperatures that can cause patient Do not modify ground or power cord.
injury (necrosis) and / or user discomfort. Do not allow liquid into console.
Use of damaged or improperly maintained power Portable and Mobile RF communications equipment can
equipment and / or misused powered equipment can affect Medical Electrical Equipment.
result in excessive temperatures.
Use of accessories or cable other than those provided
Use caution to avoid cutting or tearing gloves while by DePuy Synthes Companies, and specified for the elec-
handling dissection tools. tric system in use, may result in increased emissions or
Dissection tools must be adequately retained within attach- decreased immunity.
ment to prevent distal migration, which may cause injury. Do not use in oxygen rich environment.
Confirm attachment is proper size for dissection tool and Do not modify. Modifications could result is loss of
that it is secure. electrical safety.
Gently pull on dissection tool shaft to ensure it is fully Dispose of items contaminated with body fluids with
seated and properly installed. other biohazardous waste.
Only cut visible areas unless an image intensifier is At end of life, recycle or dispose of device in accordance
utilized. with local and national regulations.
Delicate structures in proximity to dissection must be No modification of this equipment is allowed.
thoroughly protected to prevent injury.
To avoid the risk of electric shock, this equipment must
Maintain firm control of instrument at all times. only be connected to a supply mains with protective
Do not bend or use as a lever. earth.

Precautions Do not step on, set equipment on, pinch, kink, clamp,
United States Federal law restricts this device to sale by or otherwise occlude handpiece hose during use.
or on order of a physician or other licensed healthcare To ensure equipment operates as designed, read and
provider. follow manufacturer’s instructions.
Do not use accessories other than those provided by Do not operate handpiece without an attachment and
DePuy Synthes Companies and specified for use with the corresponding dissection tool.
Anspach systems.
Do not engage safety mechanism while handpiece is
Use care to protect hose when handling, cleaning, running; doing so makes safety mechanism inoperable.
and during system use.
Damage to hose can cause leaking, rupture, or other
related failures.

4    DePuy Synthes Companies  Anspach eMax 2 Plus System  User’s Manual


TECHNICAL SPECIFICATIONS

eMax 2 Plus Handpiece Specifications Foot Pedal (E-FP, E-FP-DIR, E-FP-DIR/IRR)


Speed: 10,000 – 80,000 rpm Specifications
Handpiece / hose Length: 3.81 m (12.5 ft) Size: 26.7 cm  16.5 cm  14.7 cm
Outside housing (diameter): 18.8 mm (.74 in) (10.5 in  6.5 in  8.5 in)
Length of housing: 127 mm (5 in) Weight: 2.0 kg (4.41 lbs)
Handpiece weight: 104 g (3.7 oz) Cord: 3.66 m (12 ft) in length
Handpiece Hose Weight: 0.59 kg (1.29 lbs) Fluid Ingress Protection: IPX8

Console (SC2000, SC2100, SC2101, SC2102) Environmental Conditions


Specifications Temperature
Electrical: Operating: 18° – 30°C (65° –  85°F)
Primary: 100 – 240VAC, 50/60 Hz, Transportation and
250 VA Storage: – 40 ° – 70°C (– 40° – 158°F)
Class I: Protective Earth
Fluid Ingress Protection: IPX0 Relative Humidity
Type B: Applied Part Operating: 30 – 70%
Continuous Operation Transportation and
Storage: 10 – 95%
Mechanical:
Size: 31.115 cm  14.6 cm  32.7 cm Atmospheric Pressure
(12.25 in  5.74 in  12.87 in) Operating: 70 – 106 kpa, 0.7 – 1.06bar
Weight: 6.25 kg (13.77 lbs) Transportation and
Storage: Not applicable

The device complies with the following standards:


IEC 60601-1:2005: + CORR. 1 (2006) + CORR. 2 (2007), Patent Information
EN 60601-1:2006 +A11:2011, ANSI / AAMI ES60601- For patent information go to:
1:2005, CAN / CSA-C22.2 No.60601-1:08, (3rd Edition) www.DePuy.com / patentmarking
Medical electrical part 1: General requirements for basic
safety and essential performance. Additional Information
To isolate the device from the mains supply, remove
the power cord. All specifications are subject to change.

With regard to electrical shock, fire, mechanical hazards,


this ETL classified device conforms to AAMI STD
ES60601-1 and is certified to CSA STD C22.2
No.60601-1

This device complies with applicable EEC directives.

Anspach eMax 2 Plus System  User’s Manual   DePuy Synthes Companies    5


Technical Specifications

Table 1: Emission
The Anspach eMax 2 Plus High Speed Electric System is composed of the eMax 2 Plus Handpiece model; Electric
Consoles models SC2100, SC2101, and SC2102; Foot Control models E-FP, E-FP-DIR, E-FP-DIR/IRR, EPLUS-FP, 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 specified below.
The customer or the user of the Anspach High Speed Electric System should assure that it is used in such an
environment.
Emission test Compliance Electromagnetic environment – guidance

RF emissions Group 1 The Anspach High Speed Electric System uses RF energy only for its inter-
nal function. Therefore, its RF emissions are very low and are not likely to
CISPR 11 cause any interference in nearby electronic equipment.
RF emissions Class A The Anspach High Speed Electric System is suitable for use in all establish-
ments, other than domestic establishments and those directly connected
CISPR 11 to the public low-voltage power supply network that supplies buildings
Harmonic emissions Class A used for domestic purposes.

IEC 61000-3-2

Voltage fluctuations / Complies


flicker emissions

IEC 61000-3-3

6    DePuy Synthes Companies  Anspach eMax 2 Plus System  User’s Manual


Table 2: Immunity (all devices)

Guidance and manufacturer’s declaration – electromagnetic immunity


The Anspach High Speed Electric System is intended for use in the electromagnetic environment specified below. The
customer or the user of the Anspach High Speed Electric System should assure that it is used in such an environment.

Immunity test IEC 60601 Compliance Electromagnetic environment –


standard test level level guidance
U T (25 cycles)
Electrostatic ±6 kV contact ±6 kV contact Floors should be wood, concrete or ceramic
discharge (ESD) tile. If floors are covered with synthetic mate-
IEC 61000-4-2 ±8 kV air ±8 kV air rial, the relative humidity should be at least
30%.

Electrical fast ±2 kV for ±2 kV for Mains power quality should be that of a


transient / burst power supply lines power supply lines typical commercial or hospital environment.
±1 kV for ±1 kV for
IEC 61000-4-4 input / output lines input / output lines

Surge ±1 kV line to line ±1 kV line to line Mains power quality should be that of a
typical commercial or hospital environment.
IEC 61000-4-5 ±2 kV line to earth ±2 kV line to earth

Voltage dips, short <5 % UT (>95 % dip <5 % UT (>95 % dip Mains power quality should be that of a typi-
interruptions and in UT) for 0.5 cycle in UT) for 0.5 cycle cal commercial or hospital environment. If the
voltage variations user of the Anspach High Speed Electric Sys-
on power supply lines 40 % UT (60 % dip 40 % UT (60 % dip tem requires continued operation during
in UT) for 5 cycles in UT) for 5 cycles power mains interruptions, it is recommended
that the Anspach be powered from an unin-
70 % UT (30 % dip 70 % UT (30 % dip terruptible power supply or a battery.
in UT) for 25 cycles in UT) for 25 cycles

IEC 61000-4-11 <5 % UT (>95 % dip <5 % UT (>95 % dip


in UT) for 5 s in UT) for 5 s

Note: U T is the a.c. mains voltage prior to application of the test level.

Power frequency 3 A / m 3 A/m Power frequency magnetic fields should be


(50 / 60 Hz) at levels characteristic of a typical location in
magnetic field a typical commercial or hospital environment.

IEC 61000-4-8

Anspach eMax 2 Plus System  User’s Manual   DePuy Synthes Companies    7


Technical Specifications

Table 3: Immunity (not life-supporting devices)

Guidance and manufacturer’s declaration – electromagnetic immunity


The Anspach High Speed Electric System is intended for use in the electromagnetic environment specified below.
The customer or the user of the Anspach High Speed Electric System should assure that it is used in such an
environment.
Immunity test IEC 60601 Compliance Electromagnetic environment –
standard test level level guidance

Conducted RF 3 Vrms 3V Portable and mobile RF communications equipment


should be used no closer to any part of the Anspach High
IEC 61000-4-6 150 kHz to 80 MHz Speed Electric System, including cables, than the recom-
mended separation distance calculated from the equation
Radiated RF 3 V/m 3 V/m applicable to the frequency of the transmitter.

IEC 61000-4-3 80 MHz to 2.5 GHz 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 trans-


mitter in watts (W) according to the transmitter manufac-
turer and d is the recommended separation distance in
metres (m).

Field strengths from fixed RF transmitters, as determined


by an electromagnetic site surveya a should be less than
the compliance level in each frequency range.b

Interference may occur in the vicinity of equipment


marked with the following symbol:

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

8    DePuy Synthes Companies  Anspach eMax 2 Plus System  User’s Manual


Table 4: Recommended separation distances (not life-supporting devices)

Recommended separation distances between portable and mobile RF communications equipment


and the Anspach High Speed Electric System
The Anspach High Speed Electric System is intended for use in the electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the Anspach High Speed Electric System can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equip-
ment (transmitters) and the Anspach High Speed Electric System as recommended below, according to the maximum
output power of the communication equipment.
Rated maximum output Separation distance according to frequency of transmitter
power 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 maxi-
mum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: T hese guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Anspach eMax 2 Plus System  User’s Manual   DePuy Synthes Companies    9


GLOSSARY OF SYMBOLS

30 Sec ON / Duty Cycle of the DRIVER Located on the Foot Pedal switch this
30 Sec OFF indicates a change state (on / o ff) for the
Console Irrigation System
Company Logo
 Located on the Foot Pedal switch this
Direction of rotation indicates a change of rotational direction
for the Handpiece
Direction of rotation for lock position
SAFE

Located on the Handpiece this indicates


IndicatesSAFE
setting, position, or location SAFE
position of the knurl knob to the desired
SAFE
location
Indicates setting, position, or location SAFE
SAFE
SAFE
CUTTER
SAFE Symbol with yellow background:
RUN
CUTTER SAFE
CUTTER
ADJUST
CUTTER
CAUTION: Refer to accompanying
SAFE
RUN
ADJUST
Indicates the drill tip
SAFE
SAFE exposure
RUN RUN
TUBE documentation
SAFE

ADJUST
TUBE SAFE
ADJUST SAFE
TUBE
CUTTER
TUBE
CUTTER
CUTTER RUN
RUN
CUTTER
RUN
SAFE
SAFE ADJUST
SAFE AC Power Source
Indicates the attachmentCUTTER
ADJUST
ADJUST
RUN
CUTTER
TUBE
ADJUST
setting,
SAFE
TUBE refer
TUBE RUN
CUTTER SAFE

to MA-D20 and MA-DRIVER


CUTTER
TUBE
ADJUSTRUN
CUTTER
SAFE section in
RUN

SAFE
Consult Operating Instructions
ADJUST
RUN

F
RUN
this document for further details
F
CUTTER TUBE
ADJUST CUTTER
TUBE
ADJUST

F
ADJUST RUN
RUNTUBE TUBE
TUBE

F
CUTTER ADJUST
ADJUST
CUTTER
CUTTER
RUN
CUTTER
TUBE
 SAFE Located on the Console this indicates 2.4
TUBE
Indicates position or location
R
CUTTER RUN 2.4
1.6

F Motor or Handpiece unit
RUN RUN

F R R
ADJUST RUN 2.4 1.6
ADJUST
ADJUST ADJUST
CUTTER
TUBE CUTTER 1.6

FF or location
ADJUST
TUBE
TUBE
RUN TUBE RUN 2.4

R
TUBE 0.5

F
1.6
Indicates position
FR
ADJUST 2.4
ADJUST
2.4 Located on 0.5
the Console this indicates
F
SAFE 3.2 1.6

R F
TUBE TUBE

FR
0.5 1.6
2.4 4.8
CUTTER 1.6 Foot Control activation
2.4
6.4

R F
1.6
IndicatesF
8.0 3.2
RUN 3.2 2.4
action of rotation and position 0.5 2.4

F R and Release
1.6 4.8

R
ADJUST 4.8 2.4 0.5 1.6
0.5 2.4

F F R
2.4 6.4
for Secure (LOCK) 6.4 1.6

R
TUBE 0.5 8.0 3.2

FR
1.6

F Located on the Console this indicates
1.6 3.2 8.0
3.2 2.4
0.5 2.4
2.4 4.8 4.8

R R
(UNLOCK)
R
1.6
4.8 1.6 1.6
CUTTER
6.4
0.5
3.2
Hand Control activation 6.4
0.5 6.4

F
3.2 8.0

F
4.8 0.5 8.0
8.0 2.4 0.5
RUN 3.2
0.5

R
6.4 4.8 1.6 2.4 3.2 2.4
0.5

R
8.04.8

of R
ADJUST 6.43.2 1.6 2.4 1.6
3.24.8

Rrotation
0.5
Direction 3.2
4.8
0.5 3.2
TUBE 4.8
6.4
8.04.8
8.0
6.4
1.6
  Located on the Console this indicates
2.4
6.4
4.8
8.0 2.4
6.4 3.2
6.4

FR
3.2 6.4 8.0

R
8.0
0.5 1.6 8.0 1.6
4.8
6.4
8.0
0.5 Forward (Clockwise rotation when 4.8
6.4
0.5
3.2 8.0 0.5 8.0
4.8
3.2
3.2 looking at
4.8
Handpiece from proximal
3.2

4.8 0.5
Direction of rotation for lock position 6.4 0.5
end)
2.4

R
8.0 4.86.4 6.4 1.6
8.0
3.2 6.48.0 3.2
8.0

F
4.8 4.8
6.4 6.4
8.0 8.0
 Located on the Console this indicates 0.5

 Direction of rotation Reverse 3.2


(Counterclockwise 2.4
rotation
R
4.8 1.6
6.4
when looking
8.0 at Handpiece from
 Located on the Foot Pedal switch this proximal0.5 end)
indicates a change of rotational direction 3.2
4.8
for the Handpiece  Revolution per Minute
6.4
8.0

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

SAFE

SAFE

11    DePuy Synthes Companies  Anspach eMax 2 Plus System  User’s Manual

SAFE CUTTER
Located on the Console this indicates a Single Use Only (A.K.A. Do Not Reuse)
change of irrigation rate for the Console
Irrigation System CAUTION: Refer to accompanying
documentation
Located on the Console this indicates
a change of rotational speed rate for Keep Dry (A.K.A. Protect from Moisture)
the Handpiece
Sterile unless damaged or open

Temperature Limits United States Federal law restricts this


device to sale by or on the order of a
physician or other licensed health-care
Equipotential post location
provider

 Found on the Console ON / OFF CE Mark (A.K.A. CE Mark [notified body
number], Conformité Européenne)
Meaning: Device complies with
Located
2.4
on the Console Irrigation Pump applicable EEC Directives
1.6
this indicates a possible finger pinch
point Lock (Run)
0.5
2.4


3.2 2.4
1.6
1.6 2.4
2.4

Unlock (Load)
R
1.6 1.6 2.4
4.8
6.4
8.00.5
Located on the Console
1.6

0.5 2.4
0.5 3.2
0.5
3.2
1.6 Irrigation Pump these symbols Transmitter
0.5 4.8
4.8
3.2 6.4
4.8
3.2
3.2
6.4
8.0
8.0 are not used by the user since Interference may occur in the vicinity of
6.4
4.8
4.8
8.0
6.4
0.5
the pump is self adjusting to equipment marked with this symbol.
6.4
8.0
8.0 3.2
4.8
the Irrigation Tube diameter
6.4
8.0 Type B Electrical Equipment

Reference Number (A.K.A. Item Number, Product warranty is void if seal is


Catalog Number, Part Number) damaged or removed.

Lot (A.K.A. Lot Number, Batch Number, DO NOT DISPOSE OF IN HOUSEHOLD
Batch Code) WASTE

Serial Number
Instrument System Key
Use By Date (A.K.A. Expiration Date, EM eMax 2 Plus
00/0000
Expiry)
Latex-free Certification
Manufacturer Products not made with natural rubber latex.

Authorized European Union


Representative

Sterilized Using Irradiation

Anspach eMax 2 Plus System  User’s Manual   DePuy Synthes Companies    11


EMAX 2 PLUS OPERATING INSTRUCTIONS

The system console houses the electrical components


Power Switch
that provide power, control, and cooling functions to Face Panel (Rear of Unit)
the eMax 2 Plus handpiece. It provides the user control
for all system functions via an integral touch pad face
panel. The system console has connections for the eMax
2 Plus handpiece, foot controls, AC power inlet and the
main power switch.
The eMax 2 Plus High Speed Handpiece operates
Handpiece
continuously at speeds up to 80,000 rpm. Connector Port Foot Control
Connector Port

Back of System Console

IV Pole
Mount

Power Switch AC Power Inlet*

Swivel (270°)
Attachment Connection

Knurled Knob

Protective
Cap

Handpiece Housing
Handpiece Hose

Handpiece Hose Connector

* If two foot controls or two handpieces are connected


upon startup of console it will default to Foot Control Note: The hose length shown above is shorter than
1 and/or Handpiece 1. the actual length for easier viewing. Hose length is
** “Port” LED on console face panel does not illuminate
when this accessory is connected to console. 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.

11    DePuy Synthes Companies  Anspach eMax 2 Plus System  User’s Manual


System Assembly
1. Plug the hospital grade AC power cord into the AC
power inlet on the back of the console. Plug the op-
posite 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 con-
nector port located on front of console. (A second
handpiece could be connected into Handpiece 2 con-
nector 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. Appro-
priate Face Panel Light Emitting Diodes (LED) illumi-
nate, and a beep sounds.
5. For operating instructions see Console Face Panel
Operation and Foot Control Operation below.

Note: Handpiece is fully functional at this time.

Warning: Before first use clean and sterilize as


indicated.

Anspach eMax 2 Plus System  User’s Manual   DePuy Synthes Companies    11


eMax 2 Plus Operating Instructions

Operating Instructions
Upon startup, console is set to operate handpiece in for- Increase Speed

ward (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 opera-
tion can also be controlled by several available foot con- Decrease Speed

trol options and an optional hand control.

Console Face Panel Operation LED: Forward


1. To increase or decrease speed of handpiece, depress F: Forward
blue arrows located on console face panel. Speed in-
creases 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
R: Reverse
40 = 40,000 RPM LED: Reverse
50 = 50,000 RPM
60 = 60,000 RPM
70 = 70,000 RPM Hand Control
80 = 80,000 RPM LED: Foot
2. To change direction, depress “R” or “F” arrow located Control #1

on console face panel. Console beeps once, indicating


handpiece direction has changed. Direction can only LED: Foot
be changed when handpiece is not running. A series Control #2

of three beeps indicates console is set to operate


handpiece in reverse/counterclockwise direction. LED Irrigation Foot Control
on console face panel located to left of “F” indicates Increase / Decrease
Irrigation ON /OFF
forward direction. LED located to left of “R” indicates
reverse direction.
Note: Depressing simultaneously the Irrigation
3. Optional: To activate irrigation, depress “Irrigation”
Increase and Decrease buttons will display
button on face panel. LED illuminates. To control flow
the Console Software version as a two digit number.
of irrigation, depress arrows located to right of irriga-
tion button on face panel.
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.

11    DePuy Synthes Companies  Anspach eMax 2 Plus System  User’s Manual


Foot Control Operation
Directional
Certain optional foot controls have direction and irriga-
Control
tion control switches. 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 EPLUS-FP or EPLUS-FP-NS Foot Control
at a time.

Note: Handpiece is fully functional at this time.

3. Press on foot control pedal to start handpiece. In-


crease pressure on pedal to increase speed of hand-
piece 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
E-FP Foot Control
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. Directional
5. Optional: To activate irrigation, depress Irrigation Con- Control
Switch
trol 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-DIR /IRR Foot Control

Anspach eMax 2 Plus System  User’s Manual   DePuy Synthes Companies    11


eMax 2 Plus Operating Instructions

Hand Control Assembly and Operation


Optional hand control attachment for handpiece allows
Dimple
user to control operation with a lever attached to hand-
piece.
Inser
t to
Warnings: L o ck

• Do not expose handpiece to magnets (such as lay- Notch lines up


with Dimple
ing handpiece on magnetic drapes) when in hand
control mode, as handpiece operation may occur. eMax 2-HC

• It is recommended that a craniotome not be used


in conjunc­tion with Hand Control. Excessive rota-
tional force on hand control may move it resulting
in handpiece shutting down.

1. Upon console start-up Hand Control is OFF. LED is


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

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.

11    DePuy Synthes Companies  Anspach eMax 2 Plus System  User’s Manual


Optional Irrigation Assembly and Operation
(Excludes SC2102) Irrigation Pump

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.
Irrigation Pump
6. To control flow of irrigation, depress arrows located Release Button
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 illu-
minates.
➢ Increase Flow
Irrigation Tubing Set-up
LED: Irrigation
IRRIGATE-TUBE Sterile Tubing and Hoseclips ➣
Decrease Flow Flow Rate
for Irrigation System
Irrigation
IRRIGATE-TUBE-HF Sterile High Flow Tubing and (Activate and Deactivate)
Hoseclips for Irrigation System
05.001.178.01S Irrigation Tube Set, sterile,
single pack

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 dia-
­meter tubing flows towards the Anspach handpiece
housing).
2. Close lid on pump head.
3. Insert bayonet end of tubing into irrigation bag.

Caution: Tubing can disconnect from connectors


without warning if occluded. DO NOT step on, set
equipment on, pinch, kink, clamp, or otherwise
occlude tubing during use.

Irrigation Attachment Clip Assembly


Refer to “Components” section for part numbers.
1. Slide irrigation tubing onto proximal end of irrigation
attachment clip.
2. Attach irrigation attachment clip to handpiece.
3. Secure tubing to handpiece hose using Hoseclips,
which are included with tubing.

Anspach eMax 2 Plus System  User’s Manual   DePuy Synthes Companies    11


eMax 2 Plus Operating Instructions

System Shutdown Warnings:


1. There are no special procedures for system shutdown. • Irrigation tubing, attachment clip, and hose clip
2. To disconnect power cord from mains, grasp ridged por- are for SINGLE USE ONLY.
tion of connector between thumb and forefinger of • Avoid stacking or placing the eMax 2 Plus System
one hand. Gently pull the connector away from the consoles near other electrical equipment. If the
console. The connector should remove easily. If not, eMax 2 Plus System consoles must be stacked or
ensure only the ridged portion of the connector is used adjacent to other electrical equipment, it
pulled. Do not pull on the smooth part of the con­ should be observed to verify normal operation
nector, as the connector will not disengage from the prior to use
console. • The eMax 2 Plus System is Medical Electrical.
Equipment, requiring special precautions related
Cautions: to EMC, and for this reason must be put into ser-
• Do not sterilize, and do not allow liquid into vice as described in this product manual.
pump. • Firm control of the eMax 2 Plus must be main-
• Do not operate with pump head open. tained at all times. Never force the dissection tool.
Let the instrument do the cutting.
• Only Anspach cutting burrs should be used with
the eMax 2 Plus.
• Always use continuous irrigation to prevent heat
build-up. Never use the attachments as a retractor
to bend or pry.
• Power source should comply with applicable IEC,
CEC, and NEC requirements. Grounding reliability
can only be achieved when this equipment is
connected to a receptacle marked “HOSPITAL
GRADE.”

Note: If fuse replacement is necessary, use only


Time Delay fuse rated 2.5A, 250V. Item to be
replaced by a DePuy Synthes Companies repair
facility ONLY.

11    DePuy Synthes Companies  Anspach eMax 2 Plus System  User’s Manual


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
DePuy Synthes Power Tools for service.

E2 Handpiece Lock 10 slow beeps Rotate the knurled knob on handpiece clockwise
Engaged to ensure the handpiece is not locked.

E3 Handpiece Stall 10 fast beeps Remove pressure from foot control (or hand
Warning control), remove cutter from stalled location and
restart handpiece.

E4, E5 Fault in Handpiece None Return console and handpiece to DePuy Synthes
Companies for service.

E6, E7 Handpiece overheat 5 second beep Reduce or remove load from handpiece to allow
warning, impending handpiece to cool. If load is not reduced
handpiece shutdown sufficiently, handpiece will shut down 30 seconds
after tone is heard and/or code is displayed.

E9 Handpiece type None Disconnect connector and reconnect to console. If


not recognized fault does not clear, return handpiece and consol
to DePuy Synthes Companies for service.

None Handpiece set 3 beeps


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

Anspach eMax 2 Plus System  User’s Manual   DePuy Synthes Companies    11


STANDARD ATTACHMENTS
AND DISSECTION TOOL ASSEMBLY

Straight Attachment Assembly


Motor Housing/Handpiece Knurled Straight Attachment Dissection Tool
Knob

Craniotome Attachment Assembly


Motor Housing / Handpiece Knurled Dissection Tool Craniotome Attachment
Knob

Dissection Tool Identification


All dissection tools are packaged sterile, unless other-
wise indicated, and are manufactured for single use.
Each dissection tool has a series of identification num-
bers and letters imprinted on the label and on the shaft.
The first letter describes the type of attachment, and
the following characters indicate the size and style of the
dissection tool. An example follows:

Dissection Tool Part Number: S-2B

Dissection Tool Description: 2 mm Fluted Ball


for Short attachment

Note: Each attachment is laser-marked with its


corresponding part number.

22    DePuy Synthes Companies  Anspach eMax 2 Plus System  User’s Manual


Straight Attachments
SHORT   5 cm Short Attachment Distal End
MEDIUM   8 cm Medium Attachment
LONG 11 cm Long Attachment
MIA16 16 cm Minimally Invasive Attachment Handpiece
SHORT-HD   5 cm Heavy Duty Short Attachment Knurled Knob
MEDIUM-HD   8 cm Heavy Duty Medium Attachment
LONG-HD 12.4 cm Heavy Duty Long Attachment
XL-HD 20.2 cm Heavy Duty Extra Long
Attachment
Arrows and
Note: Instructions are written such that distal end Symbols Handpiece
of handpiece and attachment are pointed away from
user.

The arrows, symbols, and printing on the distal end of


the handpiece housing (“RUN” ( ), “LOAD” ( ) and
eMax Straight Attachments
“SAFE”) refer to locking and unlocking the attachment
and dissection tool onto the handpiece. SHORT
1. Move handpiece knurled knob to “RUN” ( )
position. MEDIUM

2. Slide attachment over distal end of handpiece. Pull at-


tachment towards handpiece, and rotate attachment LONG

to right approximately one-quarter turn until fully


MIA16
seated. Handpiece knurled knob moves up to seat
next to attachment.
SHORT-HD
3. Pull handpiece knurled knob towards “LOAD” ( )
position and insert dissection tool into distal end of
MEDIUM-HD
attachment. Rotate dissection tool slowly until fully
seated.
LONG-HD
4. Release handpiece knurled knob into “RUN” ( )
XL-HD
position.

Note: Handpiece is now fully functional.

5. Pull dissection tool to ensure proper engagement.


6. Attachment and dissection tool are secure.

Disassembly
1. Move handpiece knurled knob to “SAFE” position.
2. Remove dissection tool from distal end of attachment.
3. R
 otate attachment to left approximately one-quarter
turn, and remove from distal end of handpiece.

Anspach eMax 2 Plus System  User’s Manual   DePuy Synthes Companies    22


Standard Attachments and Dissection Tool Assembly

Orange 45° or 90° Contra Angle Attachments ORANGE-45


ORANGE-45 45° Contra Angle Attachment
ORANGE-90 90° Right Angle Attachment
Note: Instructions are written such that distal end
of handpiece and attachment are pointed away from
user.
ORANGE-90
1. Ensure knurled knob on handpiece is in “RUN”( )
position.
2. Slide attachment over distal end of handpiece. Push
attachment towards handpiece, and rotate attach-
ment clockwise until fully seated. Handpiece knurled
knob moves up to seat next to attachment.
3. Push latch on the distal end of the attachment up
with your thumb.
4. Insert dissection tool into the side of the distal end
(opposite side of latch) while rotating slowly until
dissection tool seats.
5. Release latch and check security of attachment by
pulling it away from handpiece and check dissection
tool by pulling on dissection tool head. Latch will be
flush with attachment when dissection tool is secure.

Note: Handpiece is now fully functional.

Disassembly
1. Lift latch on the distal end of the attachment with
your thumb. Remove dissection tool and release latch.
2. Move handpiece knurled knob to “SAFE” position.
3. Rotate attachment counterclockwise and remove
from distal end of handpiece.

22    DePuy Synthes Companies  Anspach eMax 2 Plus System  User’s Manual


Craniotome and Specialty Attachments
CRANI-P
CRANI-P 6.5 cm Pediatric Craniotome
CRANI-A 6.5 cm Adult Craniotome
CRANI-L 7.5 cm Large Craniotome CRANI-A
CRANI-A-R 6.5 cm Rotating Adult Craniotome
ADG 7.2 cm Adjustable Drill Guide
CRANI-L
CDA 6.8 cm Controlled Depth Attachment

Warning: It is recommended that a craniotome not CRANI-A-R

be used in conjunction with Hand Control. Exces-


sive rotational force on hand control may move it ADG
resulting in handpiece shutting down.

Note: Instructions are written such that distal end CDA

of handpiece and attachment are pointed away from


user.

1. Pull handpiece knurled knob towards “LOAD” ( )


position and insert dissection tool into distal end
of handpiece. Rotate dissection tool slowly until
dissection tool is fully seated.
2. Release handpiece knurled knob into “RUN” ( )
position.

Note: Handpiece is now fully functional.

3. Pull dissection tool to ensure proper engagement.


4. Slide attachment over distal end of handpiece. Pull at-
tachment towards handpiece, and rotate attachment
to right approximately one-quarter turn until fully
seated. Handpiece knurled knob moves up to seat next to
attachment.
5. Attachment and dissection tool are secure.

Disassembly
1. Move handpiece knurled knob to “SAFE” position.
2. R
 otate attachment to left approximately one-quarter
turn, and remove from distal end of handpiece.
3. Remove dissection tool from distal end of attachment.

Anspach eMax 2 Plus System  User’s Manual   DePuy Synthes Companies    22


Standard Attachments and Dissection Tool Assembly

QD Angle Attachments QD8


QD8   8 cm Quick Disconnect Angle Attachment
QD11 11 cm Quick Disconnect Angle Attachment
QD14 14 cm Quick Disconnect Angle Attachment
QD8-S   7.5 cm Angle Attachment QD11
QD11-S 10.5 cm Angle Attachment
QD14-S 13.5 cm Angle Attachment
QD14

Note: Instructions are written such that distal end


of handpiece and attachment are pointed away from
user.

1. Move handpiece knurled knob to “RUN” ( ) position.


2. Slide attachment over distal end of handpiece. Pull
attachment towards handpiece, and rotate attach-
ment to right approximately one-quarter turn until
fully seated. Handpiece knurled knob moves up to
seat next to attachment.
3. Pull retaining sleeve on angle attachment towards
handpiece and rotate to left to the “RELEASE”
position.
4. Insert dissection tool into angle attachment. Rotate
dissection tool slowly until it is fully seated. Release
retaining sleeve on angle attachment by rotating
retaining sleeve to right to the “SECURE” position.

Note: Handpiece is now fully functional.

5. Pull dissection tool to ensure proper engagement.


6. Attachment and dissection tool are secure.

Disassembly
1. Pull retaining sleeve on angle attachment towards
handpiece and rotate to left.
2. Remove dissection tool from distal end of attachment.
3. Move handpiece knurled knob to “SAFE” position.
4. Rotate attachment to left approximately one-quarter
turn, and remove from distal end of handpiece.

22    DePuy Synthes Companies  Anspach eMax 2 Plus System  User’s Manual


OTOLOGIC CURVED MICRO (OCM) ATTACHMENT
AND OTOLOGIC CURVED MICRO (OCM) BURR
SUPPORT SLEEVES

Device Description OCM Installation for XMAX and EMAX 2 Plus


The Otologic Curved Micro (OCM) Attachment connects Systems Handpieces
to XMAX® Pneumatic and EMAX 2 Plus Electric Systems 1. Ensure handpiece is in “RUN” or “SECURE” position.
and accepts OCM Burr Support Sleeves which are avail- 2. Insert OCM Attachment’s drive shaft into distal end
able in various cutting burr styles. of handpiece, push and rotate to right until it stops.
Listen for a click as handpiece knurled knob moves up
The OCM Burr Support Sleeve (OCM Burr) consists of the to seat next to OCM Attachment.
cutter and an outer sleeve that protects and supports 3. Gently twist back and forth to ensure OCM Attach-
the rotating shaft of the cutting burr. ment is locked into position.

OCM Burr
Flat End OCM Burr Support Sleeve Assembly
Support Sleeve
1. Line up arrow located on the distal end of OCM
­Attachment with flat end of OCM Burr, push until
Grooves fully seated. Listen for a click. (Illustration 1)
Drive Shaft
MCA Distal End 2. Gently pull OCM Burr to ensure it is locked into
­position.
Side view

OCM Distal End

Indications for Use


When used with the ANSPACH Systems, the OCM At- OCM Burr
Support Sleeve
tachment and OCM Burr Support Sleeves are intended
for cutting, and shaping bone primarily in otology pro­
cedures such as cochleostomies. Grooves
Arrow
Flat End
Warning: Illustration 1 (Top view)
• Prior to first use, the OCM Attachment must be
processed as per the included Cleaning and Steril-
ization instructions. Curved Burr Support Sleeve Disassembly
• It is not intended for gross bone removal. Heavy 1. Remove OCM Burr from distal end of OCM Attach-
loading and/or lack of irrigation while performing ment by grasping OCM Burr at grooves. (Illustration 1)
bone dissection may result in burr fracture. 2. Treat the OCM Burr Support Sleeve as biohazardous
• Prior to use, visually inspect the instrument(s). Do waste and dispose of accordingly.
not use the instrument(s) if damaged.
• To avoid overheating this device, employ a duty OCM Disassembly for XMAX and EMAX 2 Plus
cycle of 10 seconds ON and 10 seconds OFF for an Systems Handpieces
unlimited number of cycles. 1. Move handpiece knurled knob to “SAFE” position.
2. Rotate OCM Attachment to left approximately one
Note: When following these instructions hold quarter turn, and remove from distal end of hand-
handpiece and attachments with distal end pointing piece housing.
away from user.

Anspach eMax 2 Plus System  User’s Manual   DePuy Synthes Companies    22


MINIMAL ACCESS ATTACHMENT
AND DISSECTION TOOL ASSEMBLY

Note: Instructions are the same for straight or an-


gled drivers and for straight or curved bearing
MA-D20
sleeves in both 10 cm, 15 cm, and 19 cm lengths. The
four words labeled on the drivers mean the follow-
ing:

CUTTER ­­– Insert or remove dissection tool. MA-DRIVER


RUN – Attachment and dissection tool are
now functional.
ADJUST –  Bearing Sleeve can be moved 3 mm
forward or back.
TUBE – Insert or remove bearing sleeve.

Warning: The Minimal Access Attachments are to


be used only for bone dissection applications. Exces-
sive force or side loads during use can cause rapid tem-
perature increase at the distal end of the attachment.
Always use copious irrigation with this attachment.

Driver Installation
MA-D20 20° Angle Driver
MA-DRIVER Minimal Access Straight Driver

Note: Instructions are written such that distal end


of handpiece and attachment are pointed away from
user.

1. Ensure handpiece knurled knob is in “Run” ( )


position.
2. Insert drive shaft of driver into distal end of hand-
piece, push and rotate to right until it stops. Listen for
a click as handpiece knurled knob moves up to seat
next to driver.
3. Gently twist back and forth to ensure driver is locked
into position.

22    DePuy Synthes Companies  Anspach eMax 2 Plus System  User’s Manual


Bearing Sleeve and Dissection Tool Assembly
(20° Angle Driver or Straight Driver)
MA-10S Bearing Sleeve, 10 cm Straight
MA-10C Bearing Sleeve, 10 cm Curved
MA-15S Bearing Sleeve, 15 cm Straight
MA-15C Bearing Sleeve, 15 cm Curved
MA-15ST Bearing Sleeve, 15 cm Straight Taper
MA-19ST Bearing Sleeve, 19 cm Straight Taper

1. Rotate knurled knob on driver to line up arrow with


“TUBE.”
2. Fully insert desired bearing sleeve into distal end of
driver by lining up black line on bearing sleeve with
black line on driver.
3. Rotate knurled knob to line up arrow with “CUTTER.”
Check security of bearing sleeve by pulling distally.
4. Insert dissection tool into distal tip of bearing sleeve.
Rotate dissection tool slowly until it is fully seated.
Rotate knurled knob on driver to line arrow with
“RUN.”

Note: Additional force is required to seat dissection


tool into curved bearing sleeve.

5. Check security of dissection tool by pulling distally on


dissection tool head.
6. Bearing sleeve and dissection tool are secure.

Dissection Tool Disassembly


1. R
 otate knurled knob on driver to line up arrow with
“CUTTER.” Remove dissection tool from distal end
of attachment.

Bearing Sleeve Adjustment


1. R
 otate knurled knob on driver to line up arrow
with “ADJUST.”
2. P ull bearing sleeve either 3 mm distally or proximally
to desired exposure.
3. Rotate knurled knob on driver to line up arrow with
“RUN.”

Bearing Sleeve Disassembly


1. R
 otate knurled knob on driver to line up arrow with
“TUBE.” Remove bearing sleeve from distal end of
driver.

Anspach eMax 2 Plus System  User’s Manual   DePuy Synthes Companies    22


MICROSAWS AND SMALL
ATTACHMENTS ASSEMBLY

The microSaws were designed for small bone dissec-


tion. The microSaw Driver provides direct connection to
all DePuy Synthes Companies electric handpiece sys-
tems. The Driver also enables rapid exchange of saw
head styles through a unique quick-disconnect system. DRIVER

Keyless Driver Installation


DRIVER Keyless Driver
Note: Instructions are written such that distal end
of handpiece and attachment are pointed away from
user.

Keyless Driver Installation


1. Ensure knurled knob on handpiece is in “RUN” ( )
position.
2. Insert drive shaft of keyless driver into handpiece and
rotate clockwise until locked. Gently twist back and
forth to ensure it is locked into position.

Keyless Driver Removal (DRIVER)


1. Move handpiece knurled knob to “SAFE” position.
2. Rotate DRIVER counterclockwise and remove.

DRIVER Duty Cycle


30 Sec ON, 30 Sec OFF for eight cycles. This duty cycle is
required to meet vibration standard for a maximum of
8 minutes in an 8 hour time frame.
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).

22    DePuy Synthes Companies  Anspach eMax 2 Plus System  User’s Manual


Oscillating, Sagittal, and Reciprocating Saw S-SAW
Attachment Assembly
S-SAW Sagittal microSaw Attachment
R-SAW Reciprocating microSaw Attachment
O-SAW Oscillating microSaw Attachment

1. Insert attachment drive shaft into distal end of keyless


driver. Rotate until three tabs on attachment engage
R-SAW
three slots in keyless driver.
2. Continue to rotate counterclockwise while pushing
attachment into keyless driver until attachment locks
into position and release ring snaps into position.
When fully engaged, contours on keyless driver body,
release ring, and saw attachment will be in alignment.

Oscillating Saw Blade Assembly O-SAW


1. P ress down on release button to open saw blade
mounting plates.
2. Insert saw blade into opening and align saw blade
hub with locking pins in mounting plates. Oscillating
saw blades can be aligned in 45° increments.
3. R elease button and ensure mounting plates are firmly
seated on saw blade without gaps.

Sagittal Saw Blade Assembly


1. P ress down on release button to open saw blade
mounting plate.
2. Insert saw blade into opening through slot on mount-
ing plate and align saw blade hub with locking pins in
mounting plate.
3. R elease button and ensure mounting plate is firmly
seated on saw blade without gaps.

Reciprocating Saw Blade Assembly


1. Rotate chuck counterclockwise until chuck has opened
sufficiently to accept a saw blade.
2. If blade has a shank with a shaft, insert shaft of blade
in chuck jaws until it is fully inserted and tighten
chuck knob clockwise until snug.
3. If blade has a flat shank, insert blade into slots in
chuck until it is fully inserted and tighten chuck knob
clockwise until snug.

Saw Blade Removal


1. Saw blade removal is reverse of installation.

Anspach eMax 2 Plus System  User’s Manual   DePuy Synthes Companies    22


microSaws and Small Attachments Assembly

J-Latch and Jacobs Chuck Small Attachments SA-JLATCH


Assembly
DRIVER Keyless Driver
SA-JLATCH Small Attachment, J-Latch
SA-JACOBS Small Attachment, Jacobs Chuck

Note: DePuy Synthes Companies does not supply


dissection tools for SA-JLATCH or SA-JACOBS SA-JACOBS
small attachments.
Keyless driver refers to DRIVER.
1. Insert attachment drive shaft into distal end of keyless
driver. Rotate until three tabs on attachment engage
three slots in keyless driver.
2. C ontinue to rotate counterclockwise while pushing
attachment into keyless driver until attachment locks
into position and release ring snaps into position. Caution: Do not press down on release button while
3. W hen fully engaged, contours on keyless driver body, attachment is in use.
release ring, and small attachment will be in align-
ment. Keyless Jacobs Chuck Dissection Tool Removal
1. Press down on center of release button located on
J-Latch Dissection Tool Assembly
SA-JACOBS attachment while rotating knurled knob
1. P ull back distal sleeve in direction of arrow on
SA-JLATCH attachment and hold it down to insert on attachment clockwise until fully opened.
dissection tool into distal end of attachment. 2. Pull dissection tool out distally for removal.
2. Rotate dissection tool slowly until fully seated. 3. Release button.
3. R elease distal sleeve and check security of dissection
Disassembly
tool by pulling distally on dissection tool.
4. Dissection tool and attachment are secure. microSaw and Small Attachment Removal
1. W
 ith one hand supporting attachment, rotate release
J-Latch Dissection Tool Removal ring on keyless driver with other hand counterclock-
1. P ull back distal sleeve in the direction of arrow on wise until attachment is released.
SA-JLATCH and hold it down while pulling dissection
tool out distally for removal.
2. Release the distal sleeve.

Keyless Jacobs Chuck Dissection Tool Assembly


1. P ress down on center of release button located on
SA-JACOBS attachment while rotating knurled knob
on attachment clockwise until fully opened.
2. Insert dissection tool into distal end of attachment
until it touches bottom.
3. R otate knurled knob counterclockwise while centering
dissection tool on attachment until tight; release but-
ton.
4. Check security of dissection tool by pulling distally on
dissection tool.
5. Dissection tool and attachment are secure.

33    DePuy Synthes Companies  Anspach eMax 2 Plus System  User’s Manual


PERFORATOR DRIVER

Perforator Driver
CSR60 Perforator Driver with Hudson End

This perforator driver attachment allows hudson style


cranial perforators to be used with the eMax 2 Plus Sys-
tems (60:1 Ratio, approximately 1,300 rpm.)

Refer to the cranial perforator manufacturer’s operating


instructions for rotational speed requirements.
Note: Instructions are written such that distal end
of handpiece and attachment are pointed away from
user.

1. Remove red storage cover.


2. Move handpiece knurled knob to “RUN” ( ) position.
3. Slide SpeedReducer over distal end of handpiece. Pull
SpeedReducer towards handpiece and rotate to right
approximately one-quarter turn until fully seated.
Handpiece knurled knob will move up to seat next
to SpeedReducer.
4. Pull SpeedReducer retaining sleeve towards hand-
piece. Insert Hudson-end of cranial perforator and
release retaining sleeve.

Disassembly
1. P ull SpeedReducer retaining sleeve towards handpiece
and remove cranial perforator from distal end of
SpeedReducer.
2. Move handpiece knurled knob to “SAFE” position.
3. R otate SpeedReducer to left approximately one-quar-
ter turn and remove from distal end of handpiece.
4. Replace red storage cover.

Note: The red storage cap provided with the Perfora-


tor Driver is to prevent damage to the shaft. The cap
is removed for cleaning, washing and sterilization.
The cap is used for storage purposes only.

Anspach eMax 2 Plus System  User’s Manual   DePuy Synthes Companies    33


INSPECTION AND MAINTENANCE

Perform these activities regularly as per institution policy.

Warning: Do not use any damaged equipment.


Return to DePuy Synthes Companies repair
facility.

Attachments
Straight Attachments Visually inspect for any damage to the tube.
• LONG
• LONG-S
• LONG-01 SHORT
• LONG-HD
• MEDIUM
• MEDIUM-HD
• MIA16
• SHORT
• SHORT-HD
• XL-HD Visually inspect for bent or broken drive shaft
and for any damage to the tube.
Angle Attachments
• MA-D20
• MA-DRIVER
• QD8 QD8
• QD8-S
• QD11
• QD11-S
• QD14
• QD14-S
Visually inspect for bent or broken foot.
Craniotomes
• CRANI-A
• CRANI-A-R
CRANI-A
• CRANI-L
• CRANI-P
• CRANI-01
• CRANI-L-R

33    DePuy Synthes Companies  Anspach eMax 2 Plus System  User’s Manual


Other Attachments Visually inspect for overall damage or missing components.
• ADG
• CDA
• CSR60
• DRIVER
• ORANGE-45
• ORANGE-90
• O-SAW
• R-SAW
CSR60
• S-SAW
• SA-JACOBS
• SA-JLATCH
• OCM
• Visually inspect for damage electrical cord or connector.
• Visually inspect for damage or cracks to the housing
Foot Controls
or pedal.
• E-FP
• E-FP-DIR
• E-FP-DIR / IRR
• EPLUS-FP
• EPLUS-FP-NS

E-FP

Anspach eMax 2 Plus System  User’s Manual   DePuy Synthes Companies    33


Inspection and Maintenance

Hand Controls •  Visually inspect for damage to the levers.


•  E-HC •  Visually inspect for presence of magnet on the
•  EMAX2-HC lever mechanism.

Magnet
EMAX2-HC

Handpiece Ensure that the knurl knob operates properly.


•  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.

14 DePuy Synthes Companies Anspach eMax 2 Plus System User’s Manual


Consoles • Visually inspect for damage or cracks to the housing.
• SC2100 • Visually inspect for damage to the electrical power
• SC2101 cord.
• SC2102

• Power the system and inspect for illumination of


the LEDs.
• If there is an irrigation pump present check for
proper function.

If the irrigation flow LED display is not on,


press the Drop button.

SAFE

CUTTER
RUN
ADJUST
TUBE

F
2.4

R
1.6

0.5

3.2
4.8
6.4
8.0

Anspach eMax 2 Plus System  User’s Manual   DePuy Synthes Companies    33


CLEANING INSTRUCTIONS

ELECTRIC HIGH SPEED SYSTEMS


The following manual cleaning and mechanical/auto- Contact your Sales Representative for replacement of
mated cleaning with manual pre-cleaning instructions product incinerated under this policy or for temporary
have been validated by DePuy Synthes Companies for equipment while the original equipment is quarantined.
preparing a nonsterile medical device; this instruction is Contact the DePuy Synthes Companies Customer Service
provided in accordance with ISO 17664:2004 and ANSI/ department regarding TSE/CJD contamination for addi-
AAMI ST81:2004. tional information.

Warning: Transmissible Spongiform Encephakopa-


thies (TSE). DePuy Synthes Companies will not au-
thorize or accept the return of products that directly
contact patients or are contaminated with body fluids
of a patient who is suspected or confirmed with a
Transmissible Spongiform Encephalopathies/
Creutzfeldt-Jakob Disease (TSE/CJD) diagnosis.
DePuy Synthes Companies recommends that all
DePuy Synthes Companies products used on a
patient confirmed with a TSE/CJD diagnosis
be incinerated. DePuy Synthes Companies dissect-
ing tools used on a patient suspected of TSE/CJD
diagnosis must be incinerated.

Note: At the point of use the equipment should be


wiped of any gross soil and transferred to the clean-
ing and sterilization area for immediate processing.

33    DePuy Synthes Companies  Anspach eMax 2 Plus System  User’s Manual


MANUAL CLEANING

HIGH SPEED HANDPIECES


Detergents Precautions:
• Neutral PH enzymatic detergents are recommended • Do not immerse! Do not insert brush into hand-
for the manual washing of the high speed handpieces. piece housing. Do not use saline solution for clean-
• Alkaline detergents with a maximum pH of 11 may be ing. Do not use cleaners containing chlorinated
used but user must demonstrate their effectiveness. phenols of any concentration. Using cleaners/disin-
• The process, detergent and any additives must be fecting agents containing chlorinated phenols will
discussed with detergent manufacturer. result in premature hose failure.
• Do not use alkaline detergent with a pH greater
Warning: Wear eye protection and any additional than 11. Alkaline detergents attack grease and
PPE required. seals which can increase wear and cause device
malfunction.
• Please note: use of alkaline detergents can cause
color to fade but this does not impair function of
device.
1
Preparation
Assemble all necessary supplies such as a lint-free cloth.

Remove the attachment and dissection tool from the


handpiece (Figure 1).

Place the attached cap onto the console connector end


of the handpiece (Figure 2).
Figure 1

2
Clean
Wipe with a clean, deionized, distilled, or purified
water-dampened cloth and mild detergent (neutral pH).

Precaution: DO NOT IMMERSE. Handpiece must


not be exposed to ingress of water or to severe physi-
cal trauma; degradation of unit function and/or per-
formance may occur.
Figure 2
3
Inspect
Visually inspect the handpiece and repeat step 2 until no
visible soil remains.

Anspach eMax 2 Plus System  User’s Manual   DePuy Synthes Companies    33


Manual Cleaning
Attachments

ATTACHMENTS
Caution: Manual Cleaning Instructions for all Note: “DO NOT IMMERSE” as marked on attach-
Attachments except the Minimal Access (MA) ments is for OR personnel only.
Attachments and bearing sleeves.
Please refer to cleaning instructions provided with
Detergents the MA attachments for Minimal Access (MA) At-
• Alkaline detergents with a maximum pH of 11 are tachments, Minimal Access Drivers (MA-D20, MA-
recommended for the manual washing of the attach- DRIVER), Minimal Access Bearing Sleeves (MA-10S,
ments. MA-10C, MA-15S, MA-15C, MA-15ST, & MA-19ST).
• The process, detergent and any additives must be
discussed with detergent manufacturer.

Warning: Wear eye protection and any additional


PPE required.

Caution: Do not use alkaline detergent with a pH


greater than 11. Alkaline detergents attack grease
and seals which can increase wear and cause device
malfunction. Please note use of alkaline detergents
can cause color to fade but this does not impair
function of device. Do not use ultrasonic equipment
or corrosive or harsh chemical soaps. Do not rinse
attachment with saline solution.

1
Preparation
Assemble all necessary supplies including Attachment
Cleaning Brush (ACB), sponge, lint-free cloth and soft
bristle brush. Remove the attachment and dissection
tool from the handpiece (Figure 1).

CSR60 only: The red storage cap provided with the


Perforator Driver is to prevent damage to the shaft.
The cap is removed for cleaning, washing and steriliza- Figure 1 Figure 2
tion (Figure 2). The cap is used for storage purposes
only.

2
Immerse
Fully immerse the attachment in an alkaline cleaner
(non-chlorinated detergent), prepared as described on
the product label, at room temperature, in a suitable
container and agitate for 15 seconds (Figure 3).
Figure 3

33    DePuy Synthes Companies  Anspach eMax 2 Plus System  User’s Manual


3
Clean Cannulations

Caution: This step refers ONLY to the following


attachments (for other attachment proceed to step 4):

Type of Attachment Names of Attachments


Straight Attachments SHORT, MEDIUM, LONG, MIA16, SHORT-HD, MEDIUM-HD, LONG-HD, XL-HD, LONG-S,
LONG-01
Craniotomes CRANI-A, CRANI-A-R, CRANI-A-01, CRANI-P, CRANI-L, CRANI-L-R
Specialty Attachments ADG, CDA
QD Attachments QD8, QD8-S, QD11, QD11-S, QD14, QD14-S

Gently insert and remove Anspach Attachment Cleaning


Brush (ACB) wetted with alkaline cleaner through either
openings (distal or proximal) of the attachment as many
times as necessary to remove any foreign debris (Figure 4).

Caution: Do not insert anything into the attachment


except the ACB as specified. Do not force the brush
into or though the attachment. Do not use ACB with
MA-D20 and MA-DRIVER. ACB is to be utilized once
per system set and discarded once the system
Figure 4
cleaning is complete.

4
Rinse
Rinse the attachment in a suitable container filled with
deionized, distilled, or purified water and agitate for
15 seconds.

5
Inspect
Repeat Steps 2–4 until there is no evidence of soils or
residuals on the attachment surface or ACB.

Anspach eMax 2 Plus System  User’s Manual   DePuy Synthes Companies    33


Manual Cleaning
Attachments

ELECTRIC CONSOLES, FOOT CONTROLS AND TRAYS


Electric Console and Foot Control

Caution: Do not immerse or sterilize! Do not allow


liquid to enter the console or foot control.

1
Clean
Disconnect all power from console.

Clean console and foot control by wiping with non­


abrasive cloth and disinfectant or mild detergent and
deionized, distilled or purified water after each case.

2
Dry
Dry thoroughly with non-abrasive cloth.

E-FP

Trays
Trays can be cleaned with deionized, distilled, or purified
water and a mild detergent (pH neutral).

44    DePuy Synthes Companies  Anspach eMax 2 Plus System  User’s Manual


MANUAL PRE-CLEANING BEFORE
MECHANICAL/AUTOMATED CLEANING

HIGH SPEED HANDPIECES


Detergents
• A neutral pH enzymatic detergent is recommended.
• Alkaline detergents with a maximum pH of 11 may
be used but user must demonstrate their effectiveness.
• The process, detergent and any additives must be
discussed with detergent manufacturer.

Caution: Do not use any alkaline detergent with a


pH greater than 11. Alkaline detergents attack
grease and seals which can increase wear and cause
device to malfunction. Please note use of alkaline
detergents can cause color to fade but this does not
impair function of device.

1
Preparation
Assemble all necessary supplies including Attachment
Cleaning Brush (ACB), sponge, lint-free cloth and soft
bristle brush. Remove the attachment and dissection
tool from the handpiece (Figure 1).

Electric systems only: Place the attached cap onto


the console connector end of the handpiece (Figure 2).
Figure 1 Figure 2

2
Rinse
Rinse the handpiece with distal end pointing down under
running cold tap water or drinking water for a minimum
of two (2) minutes. Use a sponge, soft lint-free cloth or
soft bristle brush to assist in removing gross soils (Figures 3
and 4).

Caution: Do not use high pressure water or air.


Do not allow running water to enter distal end of Figure 3 Figure 4
handpiece.
Distal End

Anspach eMax 2 Plus System  User’s Manual   DePuy Synthes Companies    44


Manual Pre-Cleaning Before Mechanical / Automated Cleaning
High Speed Handpieces

3
Manipulate Moving Parts
Manipulate the handpiece knurled knob under running
cold tap water or drinking water to loosen or remove
gross soil (Figure 5).

Figure 5

4
Clean
Prepare a cleaning solution using neutral pH enzymatic
detergent per the manufacturer’s directions for correct
temperature, water quality (i.e. pH, hardness) and prod-
uct concentration / dilution.

Spray and wipe the handpiece with the cleaning solution


for a minimum of two (2) minutes. Rinse the handpiece
thoroughly under running cold tap water or drinking Figure 6 Figure 7
water for a minimum of two (2) minutes while manipu-
lating the knurled knob (Figures 6 and 7).

Use a sponge, soft lint-free cloth or soft bristle brush


to remove all visible soil.

Place locking mechanism in the “SAFE” position prior


to performing the following step (Figure 8).

Hold the handpiece at a downward angle and insert


the Anspach Cleaning Brush (ACB) wetted with cleaning Figure 8 Figure 9

solution into the distal end of the handpiece (Figure 9).

Warning: ACB is single use and should only be used


to clean one handpiece and associated attachments.

Caution: Do not immerse. Do not allow running


water to enter distal end of handpiece. Do not insert
ACB beyond last bristle. Do not force ACB into
handpiece.

42 DePuy Synthes Companies Anspach eMax 2 Plus System User’s Manual


5
Rinse Thoroughly
Rinse the handpiece thoroughly under running hot tap water
or drinking water for a minimum of two (2) minutes (Figure
10).

Place locking mechanism in “SAFE” position prior to


performing the following step (Figure 11).

Hold the handpiece at a downward angle and flush in- Figure 10 Figure 11
side of the distal end using a syringe or pipette filled
with hot tap water or drinking water (Figure 12). Place
the knurled knob in the “RUN” position (Figure 11).

Caution: Do not use high pressure water or air. Do


not immerse. Do not allow running water to enter
distal end of handpiece.

Figure 12

6
Inspect
Visually inspect the handpiece and repeat Steps 2 thru 6
until no visible soil remains.

Warning: Manual pre-cleaning must be followed by


mechanical/automated cleaning.

Anspach eMax 2 Plus System User’s Manual DePuy Synthes Companies 41


Manual Pre-Cleaning Before Mechanical / Automated Cleaning
Attachments

ATTACHMENTS
Detergents
• A neutral pH enzymatic detergent is recommended.
• Alkaline detergents with a maximum pH of 11 may be
used but user must demonstrate their effectiveness.
• The process, detergent and any additives must be
discussed with detergent manufacturer.

Caution: Do not use any alkaline detergent with a


pH greater than 11. Alkaline detergents attack
grease and seals which can increase wear and cause
device to malfunction. Please note use of alkaline
detergents can cause color to f­ ade but this does not
impair function of device.

Warning: Do not clean the MA-19ST Minimal Ac-


cess Bearing Sleeve in the EM/XM Cleaning and
Sterilization Basket. Only indicated for the MA-10S,
MA-10C, MA-15S, MA-15C, and MA-15ST.

1
Preparation
Assemble all necessary supplies including Attachment
Cleaning Brush (ACB), Small Diameter Cleaning Brush
(SDCB), sponge, lint-free cloth and soft bristle brush.
Remove the attachment and dissection tool from the
handpiece (Figure 1).

Note: Red storage cap is provided with Perforator


Driver to prevent damage to shaft. Cap is removed Figure 1 Figure 2
for cleaning, washing and sterilization (Figure 2).
Cap should be used for nonsterile storage purposes
only.

2
Rinse
Rinse the attachment under running cold tap water or
drinking water for a minimum of two (2) minutes. Use a
sponge, soft lint-free cloth or soft bristle brush to assist
in removing gross soil (Figures 3 and 4).

Caution: Do not use high pressure water or air.


Do not rinse attachment with saline solution.
Figure 3 Figure 4

44    DePuy Synthes Companies  Anspach eMax 2 Plus System  User’s Manual


3
Manipulate Moving Parts
Manipulate all moving parts such as release sleeves
under running cold tap water or drinking water to loosen
or remove gross soil (Figure 5).

Figure 5

4
Clean
Prepare a cleaning solution using neutral pH enzymatic
detergent per the manufacturer’s directions for correct
temperature, water quality (i.e. pH, hardness) and prod-
uct concentration / dilution.

Fully immerse the attachment in cleaning solution in a


suitable container and manually agitate for 2 minutes
(Figure 6). Use a sponge, soft lint-free cloth or soft Figure 6 Figure 7
bristle brush to remove all visible soil.

Gently use ACB or SDCB wetted in cleaning solution to


clean cannulations of attachment. The brushes may be
inserted from the distal or proximal end of the attach-
ment (Figure 7).

Warning: ACB and SDCB are single use and should


only be used to clean one set of attachments.

Caution: Do not force ACB or SDCB into or through


attachment. Do not use ACB or SDCB with MA-D20
and MA-DRIVER. For Minimal Access Attachment
Bearing Sleeves use SDCB only. Do not use pipe
cleaners.

Note: “DO NOT IMMERSE” as marked on the


attachment is for Operating Room personnel only.
SDCB may be inserted from distal or proximal end
of bearing sleeve.

Anspach eMax 2 Plus System  User’s Manual   DePuy Synthes Companies    44


Manual Pre-Cleaning Before Mechanical / Automated Cleaning
Attachments

5
Rinse Thoroughly
Rinse the attachment thoroughly under running hot tap
water or drinking water for a minimum of two (2) min-
utes (Figure 8). Use a syringe or pipette filled with hot
tap water or drinking water to flush lumens or channels
(Figure 9).

Caution: Do not use high pressure water or air. Do


not rinse attachment with saline solution. Figure 8 Figure 9

6
Inspect
Visually inspect the attachment and repeat Steps 2 thru
6 until no visible soil remains.

Warning: Manual pre-cleaning must be followed by


mechanical/automated cleaning.

44    DePuy Synthes Companies  Anspach eMax 2 Plus System  User’s Manual


MECHANICAL/AUTOMATED CLEANING
FOLLOWING MANUAL PRE-CLEANING

HIGH SPEED HANDPIECES AND ATTACHMENTS


Detergents
• A neutral pH enzymatic detergent is recommended.
• Alkaline detergents with a maximum pH of 11 may be
used but user must demonstrate their effectiveness.
• The process, detergent and any additives must be
discussed with detergent manufacturer.

Caution: Do not use any alkaline detergent with a


pH greater than 11. Alkaline detergents attack
grease and seals which can increase wear and cause
device to malfunction. Please note use of alkaline
detergents can cause color to fade but this does not
impair function of device. Bearings and seals of all
devices are exposed to greater stress during me-
chanical/automated cleaning than manual cleaning.
If devices are mechanically cleaned they must be
sent to a DePuy Synthes Companies Service Center at
least once a year for maintenance.

Warning: Do not clean the MA-19ST Minimal


Access Bearing Sleeve in the EM/XM Cleaning and
Sterilization Basket. Only indicated for the MA-10S,
MA-10C, MA-15S, MA-15C, and MA-15ST.

Mechanical /Automated Cleaning Guidelines


DePuy Synthes Companies can only be mechanically
cleaned under the following conditions:
• Cannulations must be pre-cleaned with appropriate
brushes as described in pre-cleaning instructions.
• Devices must not be cleaned using ultrasonic equip-
ment.
• Handpieces must not be immersed in cleaning solution
but may be sprayed with it.
• Fully demineralized (deionized) water must be used
during final rinse to prevent corrosion and spots.
• Devices must be cleaned immediately after use to en-
sure blood and tissue never dry on them.
• National regulations must be observed.
• You must follow standard hospital procedures.
• You must follow manufacturer’s recommendations for
any detergents, disinfectants and washing equipment
used.

Anspach eMax 2 Plus System  User’s Manual   DePuy Synthes Companies    44


Mechanical / Automated Cleaning Following Manual Pre-Cleaning

1
Loading the Basket
EX-BSKT-BTM EM/XM Cleaning and Sterilization
Basket Bottom
EX-BSKT-INS EM/XM Cleaning and Sterilization
Basket Insert
EX-BSKT-LID EM/XM Cleaning and Sterilization
Basket Lid

Load the devices in the basket by securing them in the ap- Figure 1 Figure 2
propriate brackets as marked on the basket (Figure 1). Refer-
ence loading configuration pictures on Page 52 for proper
placement and positioning of devices. Where applicable
distal end of devices should be angled downward.

Warning: Red protective cap for Perforator Driver


must be left off during mechanical/automated
cleaning (Figure 2).

Note: Before putting on seal cap, turn black cap


to wrap cable tight around it (Figure 3). Figure 3 Figure 4

Caution: Connector ends of electric and pneumatic


handpieces must be sealed with special seal caps
provided (Figure 4).

2
Mechanical/Automated Cleaning Cycle
Process Parameters

Cycle Duration (minimum) Cleaning Instructions


Rinse 2 minutes Cold tap water or drinking water
Pre-wash 1 minutes Warm water (≥ 40°C); use detergent
Cleaning 2 minutes Warm water (≥ 45°C); use detergent
Rinse with deionized (DI) or purified water
Rinse 5 minutes
(PURW)
Thermal Processing 5 minutes Hot DI water, ≥ 93°C
Dry 40 minutes ≥ 90°C

Caution: Do not use neutralizing agent.

3
Inspect
Visually inspect the devices and repeat the manual
pre-clean and mechanical/automated clean until no
visible soil remains.

44    DePuy Synthes Companies  Anspach eMax 2 Plus System  User’s Manual


LUBRICATION

HANDPIECES
1
Do not lubricate the handpiece.

ATTACHEMENTS
Precaution: This step is for attachments only. Do not QD8-S
lubricate handpieces. QD11
QD11-S
Option 1: QD14
05.001.078, Lubricant for Anspach Systems, 110 ml QD14-S
SA-JACOBS
Warning: Do not use Gravity Air Displacement SA-JLATCH
Steam Autoclave Sterilization Process. Only for use S-SAW
with attachments listed below. R-SAW
O-SAW
• For the following attachments apply one (1) pump ORANGE-45
spray to the proximal end of the attachment. ORANGE-90

 RANI-A
C • Applying excess amounts of lubricant will cause the lu-
CRANI-A-01 bricant to drip from the attachment. Clean off any ex-
CRANI-A-R cess lubricant.
CRANI-L
CRANI-L-R LONG Option 2: Non-Silicone Based Medical Lubricant
LONG-01
LONG-HD Note: Applicable to all attachments in List of De-
LONG-S vices section at beginning of this document.
CRANI-P
ADG • Prepare a lubricating solution of instrument milk (non-
CDA silicone based medical lubricant) per the manufactur-
MEDIUM er’s directions.
MEDIUM-HD • Fully immerse attachment in lubricating solution, at
MIA16 SHORT room temperature, in a suitable container and agitate
SHORT-HD for 15 seconds.
XL-HD • Remove attachment and allow it to drain completely
until no visible droplets are coming from it.
• For the following attachments apply one (1) pump
spray to the distal end of the attachment and one (1) Caution: Do not rinse out instrument milk (lubri-
to the proximal end of the attachment. cant). Do not apply mineral oil or other lubricants,
which may cause attachment to overheat.
CSR60
DRIVER
QD8

Anspach eMax 2 Plus System  User’s Manual   DePuy Synthes Companies    44


STERILIZATION

HIGH SPEED HANDPIECES AND ATTACHMENTS


The following sterilization instruction has been
validated by DePuy Synthes Companies in
accordance with ISO 17665.

Before sterilizing: Ensure sterilization equipment is in


proper working order as specified by manufacturer. Assure
equipment manufacturer’s instructions are properly em-
ployed by trained and qualified personnel. Assure actual
cycle employed has been properly validated for the
device(s) / load configuration being processed and appro- Figure 1
priate sterilization indicator devices are included for each
process and cycle.

Caution: Red protective cap for CSR60 must be re-


moved prior to sterilization (Figure 1). In the case
mechanical/automated cleaning was done, in the
EX-BSKT, seals cap from connector end of pneu-
matic handpiece must be removed prior to steriliza-
tion (Figure 2).

Preparation Figure 2
Following mechanical cleaning and lubrication, load the
basket and sterilize in accordance with the following
guidelines.

55    DePuy Synthes Companies  Anspach eMax 2 Plus System  User’s Manual


If using the EMAX2-TRAY
Method/Cycle Exposure Temperature Exposure Time Minimum
Dry Time
Steam Autoclave / Pre-vacuum Option 1: 132°C 4 minutes 30 minutes
(wrapped or unwrapped) Option 2: 134°C – 138°C 3 – 18 minutes 30 minutes
Steam Autoclave / Gravity Option 1: 132°C 15 minutes 30 minutes
Air Displacement (wrapped or unwrapped) Option 2: 132°C – 138°C 15 – 18 minutes 30 minutes
Warning: STERRAD® 100S – refer to the accompanying documentation of the individual products to
determine compatibility.

If using the EX-BSKT Washing and Sterilization Basket

Method/Cycle Exposure Temperature Exposure Time Minimum


Dry Time
Steam Autoclave / Pre-vacuum Option 1: 132°C 4 minutes 20 minutes
(wrapped or unwrapped) Option 2: 134°C – 138°C 3 – 18 minutes 20 minutes
Steam Autoclave/ Gravity Option 1: 132°C 15 minutes 15 minutes
Air Displacement (wrapped or unwrapped) Option 2: 132°C – 138°C 15 – 18 minutes 15 minutes

Notes: • DePuy Synthes Companies cannot anticipate all


• Foot Controls, consoles and irrigation pumps possible equipment, processes and/or conditions
should not be sterilized. that may be encountered. The suggested operation
• It is required to include the drying cycle to avoid conditions are to be considered as a starting point
possible adverse effects caused by exposure to con- for determination of the overall process capability,
densation. without regard for type or condition of equipment
used or methods, techniques or practices employed
• Metal devices, tools and equipment are con-
by user. Use of proper sterilization indicator de-
structed of materials unaffected by normal envi-
vices is strongly recommended.
ronmental conditions of current standard steril-
ization means, when proper operational
techniques are employed.
• Effectiveness of sterilization equipment or steril-
ization processes are directly dependent upon
numerous factors beyond DePuy Synthes
Companies’ control including among other things;
sterilization means, processes and wrapping tech-
niques employed, brand, model and condition of
sterilization equipment, care and maintenance
techniques employed and operator knowledge
and experience.

Anspach eMax 2 Plus System  User’s Manual   DePuy Synthes Companies    55


LOADING CONFIGURATION

HIGH SPEED HANDPIECES AND ATTACHMENTS


Seal Cap CSR60
EX-BSKT-BTM (when not in use)

Seal cap installed on EMAX2PLUS


connector end of handpiece. or XMAX

EX-BSKT-INS

SHORT MEDIUM LONG MIA16 LONG-HD MEDIUM-HD SHORT-HD

MA Bearing Sleeves MA-D20 QD8 QD11 CRANI-P CRANI-A CRANI-L


(excluding MA19-ST)

52 DePuy Synthes Companies Anspach eMax 2 Plus System User’s Manual


TROUBLESHOOTING

EMAX 2 PLUS
Problem Possible Cause Solution
Excessive handpiece noise • Faulty internal component • Return to DePuy Synthes Companies for service.
Lack of power to console • Plug is not fully inserted/power • Verify plugs to wall and back of console are pushed
switch not turned on in completely and power switch is in “I” position.
• Outlet is not functional • Verify another piece of electrical equipment can
receive power from outlet.

Handpiece vibration or • Faulty internal component • Return to DePuy Synthes Companies for service
extremely hot • Internal motor overheats due to con- • Console will shut handpiece off. If it continues
tinuous extreme cutting at near stall- to shut off during normal cutting, return to DePuy
ing conditions Synthes Companies for service.
• Hose may be kinked • Unkink hose (verify it is not being pinched or
clamped to table).
• Handpiece out of balance • Return to DePuy Synthes Companies for service.
• Handpiece hose damaged • Return to DePuy Synthes Companies for service.
Excessive vibration of • Cutting burr may be bent • Replace with new eMax 2 Plus cutting burr.
cutting burr • Cutting burr may not be fully seated • Reassemble cutting burr and attachment.
• Improper attachment and cutting • Only use correct cutting burr with appropriate
burr combination attachment.
• Possible attachment bearing damage • Return attachment to DePuy Synthes Companies
for service.

Attachment is hot • Debris lodged inside attachment • Clean attachment using DePuy Synthes Companies
Attachment Cleaning Instructions located in this
manual.
• Possible bearing damage • Return attachment to DePuy Synthes Companies
for service.

Craniotome attachment is bent • Excessive force used in operation • Do not use, replace attachment.
Inoperative Foot Control • Selected foot control on face panel • Press Foot Control button on face panel to select
(LEDs are illuminated on face does not match foot control in use other Foot Control.
panel) • System is set in hand control mode • Press Foot Control button on face panel to set it for
(LED light is illuminated) Foot Control 1 or 2, depending which one is in use.
• Plugs may not be fully inserted • Verify plugs for handpiece and foot control are fully
inserted. Plug will latch in place once fully inserted.
• Handpiece is in “Safe” position • Verify cutting burr is completely engaged and hand-
or cutter is not rotating piece’s knurled knob is in secure position.
• Defective attachment • Clean attachment or replace attachment.
Inoperative Hand Control • Defective internal component • Return to DePuy Synthes Companies for service.
• Hand Control Attachment may not • The circumferential groove on handpiece housing will
be fully installed be exposed when the Hand Control is fully installed.
• Selected Hand Control on face • Press Hand Control button on face panel to illumi-
panel is not in use nate Hand Control LED.
• Internal handpiece switch activating • Return to DePuy Synthes Companies for service.
Hand Control may be damaged

Anspach eMax 2 Plus System  User’s Manual   DePuy Synthes Companies    55


ORDERING INFORMATION

Anspach Attachments Electric Instrument System


SHORT 5 cm Short Attachment EMAX2PLUS eMax 2 Plus Handpiece
MEDIUM 8 cm Medium Attachment SC2101 System Console, with Irrigation
LONG 11 cm Long Attachment SC2102 System Console, without Irrigation
LONG-S 10.5 cm Long Attachment E-FP Electric Systems Foot Control
LONG-01 10.5 cm Long Attachment, Non-tapered End E-FP-DIR Electric Systems Foot Control with
MIA16 16 cm Minimally Invasive Attachment Direction
SHORT-HD 5 cm Heavy Duty Short Attachment E-FP-DIR/IRR Electric Systems Foot Control with
MEDIUM-HD 8 cm Heavy Duty Medium Attachment Direction and Irrigation
LONG-HD 12.4 cm Heavy Duty Long Attachment E-HC Hand Control
XL-HD 20.2 cm Heavy Duty Extra Long Attachment EMAX2-HC Hand Control
ADG 7.2 cm Adjustable Drill Guide
CDA 6.8 cm Controlled Depth Attachment Electric Instrument System Accessories
CRANI-A 6.5 cm Adult Craniotome EMAX2-TRAY Sterilization Case and Tray
CRANI-A-01 6.5 cm Adult Craniotome, Thin 05.001.100 Cart
CRANI-P 6.5 cm Pediatric Craniotome EX-BSKT EM/XM Cleaning and Sterilization Basket Set
CRANI-L 7.5 cm Large Craniotome EX-BSKT-BTM EM/XM Cleaning and Sterilization Basket
CRANI-A-R 6.5 cm Rotating Adult Craniotome Bottom
CRANI-L-R 7.5 cm Large Rotating Craniotome EX-BSKT-INS EM/XM Cleaning and Sterilization Basket
MA-D20 20° Angle Driver Insert
MA-DRIVER Minimal Access Straight Driver EX-BSKT-LID EM/XM Cleaning and Sterilization Basket Lid
MA-15S Bearing Sleeve, 15 cm Straight
MA-15C Bearing Sleeve, 15 cm Curved Irrigation System
MA-15ST Bearing Sleeve, 15 cm Straight Taper IRRIGATE-TUBE Sterile Tubing and Hoseclips for Irrigation
MA-19ST Bearing Sleeve, 19 cm Straight Taper System
MA-10S Bearing Sleeve, 10 cm Straight IRRIGATE-TUBE-HF Sterile High Flow Tubing and Hoseclips
MA-10C Bearing Sleeve, 10 cm Curved for Irrigation System
ORANGE-45 45° Contra Angle Attachment IRR-CLIP-10 Irrigation Clip for SHORT
ORANGE-90 90° Right Angle Attachment IRR-CLIP-20 Irrigation Clip for QD8, QD8-S, B-QD8
QD8 8 cm Quick Disconnect Angle Attachment IRR-CLIP-30 Irrigation Clip for SHORT-HD, B-SILVER
QD8-S 7.5 cm Quick Disconnect Angle Attachment IRR-CLIP-40 Irrigation Clip for MEDIUM-HD, LONG-
QD11 11 cm Quick Disconnect Angle Attachment HD, B-BLUE-S, B-VIOLET
QD11-S 10.5 cm Quick Disconnect Angle IRR-CLIP-50 Irrigation Clip for MEDIUM, LONG,
Attachment LONG-S, B-TURQ-L
QD14 14 cm Quick Disconnect Angle Attachment IRR-CLIP-60 Irrigation Clip for QD11, QD11-S, QD14,
QD14-S 13.5 cm Quick Disconnect Angle QD14-S, B-QD11, B-QD11-S, B-QD14,
Attachment B-QD14-S
CSR60 Perforator Driver with Hudson End
DRIVER Keyless Driver 05.001.078 Lubricant for Anspach Systems, 110 ml
OCM Otologic Curved Micro Attachment
O-SAW Oscillating microSaw Attachment
R-SAW Reciprocating microSaw Attachment
S-SAW Sagittal microSaw Attachment
SA-JLATCH Small Attachment, J-Latch
SA-JACOBS Small Attachment, Jacobs Chuck

Warranty and Return Policy is available upon request.

55    DePuy Synthes Companies  Anspach eMax 2 Plus System  User’s Manual


© DePuy Synthes Power Tools, a division of Synthes GmbH. 2015.  All rights reserved. DSEM/PWT/1014/0045 07/15

The Anspach Effort, Inc .


4500 Riverside Drive
Palm Beach Gardens, FL 33410
USA

EC REP

Synthes GmbH
Eimattstrasse 3
4436 Oberdorf
Switzerland
Tel: +41 61 965 61 11
Fax: +41 61 965 66 00
www.depuysynthes.com This publication is not intended for distribution in the USA. 0086

You might also like