pneumatIc
systems
High-speed performance and power
in a variety of applications
user’s manual
Table of Contents
Introduction
DePuy Synthes Power Tools 2
Pneumatic Instrument Systems
2
Indications3
Operating Instructions
Attachments and Dissection Tool Assembly
Warnings and Cautions
Technical Specifications
4
5
Glossary of Symbols
6
AutoLube III
Black Max
XMax 8
11
iMRI Instrument System
13
Straight Attachments and Dissection Tool Assembly
•For Black Max
•For XMax 16
18
12
Minimal Access Attachments and Dissection Tool Assembly 23
Care and Maintenance
microSaws and Small Attachments Assembly
26
Handheld Attachments Assembly
28
Cleaning Instructions
•Manual Cleaning
•Manual Precleaning Before Mechanical/
Automated Cleaning
•Mechanical/ Automated Cleaning Following
Manual Precleaning
30
31
35
Inspection and Maintenance
41
43
Lubrication46
Sterilization47
Loading Configuration
49
Troubleshooting50
Ordering Information
51
Image intensifier control
Anspach Pneumatic Systems User’s Manual DePuy Synthes Power Tools
Anspach Pneumatic Systems
High speed performance and power in a variety of applications
DePuy Synthes Power Tools
DePuy Synthes Power Tools manufactures pneumatic and
electric high performance instruments and attachments to
meet the specific needs of both surgeon and staff. While the
advanced design of these instruments provides unparalleled
performance and reliability, they also allow for effortless
assembly for the most demanding applications. No tools
are required to assemble dissection tools or attachments.
All DePuy Synthes Power Tools instruments are manufactured
to conform to rigorous quality standards to provide
dependable performance.
Warning: Before using any of the Anspach High Speed
Pneumatic 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.
High-Speed Pneumatic Systems
The XMax® System sets a new standard for the ultimate
combina­tion of high power, smooth operation, low noise
level, and small size. This new level of performance provides
the perfect pneumatic system to handle a complete range of
surgical procedures ranging from power demanding applications to the most delicate dissection. With a minimum speed
of 80,000 rpm at 120 psi (8.3 bar) input pressure, the XMax
system is one of the quietest pneumatic handpieces available,
with 35% more power than Black Max and 50% more than
microMax Plus.
The Black Max, operating at 80,000 rpm at 120 psi (8.3 bar),
offers smooth, controlled bone dissection.
The iMRI Instrument System provides an Intraoperative
MRI compatible configuration. The iMRI Instrument System
utilizes non-magnetic materials in the handpiece, attachment,
and dissection tool components that have been approved
for use with field strengths up to 1.5 Tesla.
To schedule a hands-on training course, either at
DePuy Synthes Power Tools or from your local DePuy Synthes
Power Tools Sales Representative, call (800) 327-6887 or
(561) 627-1080.
If you have any questions after reading this manual, please
call the DePuy Synthes Power Tools Customer Service
Department at (800) 327-6887 or (561) 627-1080.
Spine surgery
2 DePuy Synthes Power Tools Anspach Pneumatic Systems User’s Manual
Neurosurgery, otology and neurotology
Indications
XMax
Cutting and shaping bone
Black Max
Cutting and shaping bone
iMRI Surgical Drill System
The Anspach iMRI Surgical Drill System (including pneumatic
drill motor, foot control, nosepiece attachments, and cutters),
is indicated for intraoperative (non-imaging) use within a
Magnetic Resonance Imaging (MRI) environment rated at
1.5 Tesla or less, for surgical cutting, shaping, and removal
of bone, including bones of the skull and spine.
Black Max
XMax
iMRI
Anspach Pneumatic Systems User’s Manual DePuy Synthes Power Tools 3
Warnings and Cautions
Warnings
Only cut visible areas unless an image intensifier is utilized.
Irrigation is necessary for proper operation
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.
Delicate structures in proximity to dissection must be
thoroughly protected to prevent injury.
Instrument operator and all operating room personnel must
wear eye protection.
Use a gentle tapping motion or side-to-side motion and let
instrument do cutting.
Visually inspect for damage before using; do not use if damage
is evident.
Do not use excessive force.
Do not use if the product sterilization barrier or its packaging
is compromised.
Do not use, or discontinue use of powered equipment
exhibiting excessive temperatures that can cause patient
injury (necrosis) and/or user discomfort.
Use of damaged or improperly maintained power equipment
and / or misused powered equipment can result in
excessive temperatures.
Maintain firm control of instrument at all times.
Do not bend or use as a lever.
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 resterilize and /or reuse 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.
Use caution to avoid cutting or tearing gloves while
handling dissection tools.
Do not modify ground or power cord.
Dissection tools must be adequately retained within
attachment to prevent distal migration, which may
cause injury.
Do not use in oxygen rich environment.
Confirm attachment is proper size for dissection tool and
that it is secure.
At end of life, recycle or dispose of device in accordance with
local and national regulations. Irrigation Tubes contain DEHP
a type of phthalate.
Gently pull on dissection tool shaft to ensure it is fully seated
and properly installed.
Cautions
United States Federal law restricts this device to sale by or
on order of a physician or other licensed healthcare provider.
Do not use accessories other than those provided by
DePuy Synthes Power Tools and specified for use with
DePuy Synthes Power Tools systems.
Use care to protect hose when handling, cleaning, and during
system use.
Do not allow liquid into console.
Dispose of items contaminated with body fluids or other
biohazardous waste.
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.
Damage to hose can cause leaking, rupture, or other
related failures.
4 DePuy Synthes Power Tools Anspach Pneumatic Systems User’s Manual
Technical Specifications
BM
iMRI
iMRI Handpiece
Speed Handpiece and Hose
Outside Housing (diameter)
Length of Housing
Handpiece and hose weight
Black Max Specifications*
Speed Handpiece, muffler, hose
Outside housing (diameter)
Length of housing
Handpiece weight
up to 80,000 rpm
3.81 m (12.50 ft)
19.05 mm (0.75 in)
91.44 mm (3.60 in)
70.0 g (2.6 oz)
Handpiece, muffler, hose weight
0.65 kg (1.40 lbs)
Patent Information
DePuy Synthes Power Tools products are manufactured
under one or more of the following U.S. Patent Nos.
up to 80,000 rpm
3.81 m (12.50 ft)
17.53 mm (0.69 in)
102.36 mm (4.03 in)
75.30 g (2.7 oz)
0.65 kg (1.45 lbs)
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.
XM
XMax Specifications
Speed Handpiece, muffler, hose
Outside housing (diameter)
Length of housing
Handpiece weight
Handpiece, muffler, hose weight
This device complies with applicable EEC directives.
10,000-75,000 rpm
3.81 m (12.50 ft)
17.53 mm (0.69 in)
101.60 mm (4.00 in)
635.00 g (1.41 lb)
Additional U.S. and International patents pending.
Additional Information
All specifications are subject to change.
*The DePuy Synthes Power Tools Black Max Instrument System is not sponsored
by, endorsed by or otherwise associated with United States Manufacturing Corp.
or its Blackmax prosthetic limbs.
Anspach Pneumatic Systems User’s Manual DePuy Synthes Power Tools 5
Glossary of Symbols
SAFE
30 Sec ON/ Duty Cycle of the DRIVER
30 Sec OFF
Company Logo
Consult Operating Instructions
CUTTER
RUN
ADJUST
Temperature Limits
TUBE
SAFE
Direction of rotation
Reference Number (A.K.A. Item Number,
Catalog Number, Part Number)
Direction CUTTER
of rotation for lock position
F
RUN
ADJUST
TUBE
Indicates setting,
position, or location
Lot (A.K.A. Lot Number, Batch Number,
2.4
Batch Code)
1.6
R
Indicates setting, position, or location
0.5
Serial Number
SAFE
SAFE
SAFE
SAFE
Indicates the drill tip exposure
SAFE
SAFE
SAFE
SAFE
SAFE
SAFE
SAFE
SAFE
SAFE
CUTTER
CUTTER
RUN
CUTTER
CUTTER
CUTTER
CUTTER
RUN
ADJUST
RUN
RUN
RUN
CUTTER
CUTTER
ADJUST
RUN
TUBE
CUTTER
ADJUST
CUTTER
ADJUST
ADJUST
RUN
RUN
TUBE
ADJUST
CUTTER
RUN
TUBE
TUBE
CUTTER
RUN
CUTTER
TUBE
ADJUST
ADJUST
RUN
TUBE
ADJUST
RUN
ADJUST
RUN
TUBE
ADJUSTTUBE
TUBE
ADJUST
TUBE
ADJUST
TUBE
TUBE
TUBE
F
3.2
4.8
6.4
8.0
Single Use Only (A.K.A. Do Not Reuse)
2.4
R
1.6
Indicates the attachment setting, refer to
MA-D20 and MA-DRIVER section in this
document for further details
Manufacturer
0.5
3.2
4.8
Authorized European
Union Representative
6.4
8.0
Indicates position or location
F F or location
Indicates position
FF
F
F
F
F
R
FRFof rotation and position
Indicates F
action
FF and Release (UNLOCK)
R
for Secure (LOCK)
R
R
R
R
R
R
R
R
R
R
Direction of rotation
Sterilized Using Irradiation
2.4
Use
By Date (A.K.A. Do Not Reuse)
00/0000
2.4
1.6
1.6
2.4
1.6
0.5
0.5
3.2
0.5
4.8
3.2
0.5
3.24.8
0.5
0.5 0.5
0.50.5
4.86.4 3.2
8.0
0.5
0.56.4 3.24.83.2 3.2
8.0 0.5 0.5
3.23.2
4.8
3.2 4.86.44.8
8.0
4.84.86.4
3.2
4.83.2
6.43.26.4
6.4
8.0
4.8 6.4 8.0 8.0
6.4
8.0
4.8
8.0
6.4 8.04.8
6.4 6.4
8.0
8.0 8.0
6.4
8.0
2.4
1.6
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
Direction of rotation
Located on the Handpiece this indicates
position of the knurl knob to the desired
location
SAFE
Symbol with yellow background:
CAUTION: Refer to accompanying
documentation
F
CE Mark (A.K.A. CE Mark [notified body
number], Conformité Européenne)
Meaning: Device complies with applicable
EEC Directives
6 DePuy Synthes Power Tools Anspach Pneumatic
Systems User’s Manual
2.4
F
R
1.6
2.4
CAUTION: Refer to accompanying
documentation
Keep Dry (A.K.A. Protect from Moisture)
Direction of rotation for lock position
SAFE
2.4
1.6
2.4 2.4 2.4
2.4
1.6 1.61.6 2.4
1.6 2.4
1.6
2.4 2.4
1.6
1.6 1.6
Glossary of Symbols
Certified/Accredited Test House
Lock (Run)
Unlock (Load)
Product warranty is void if seal is damaged
or removed.
Humidity Limits
Instrument System Key
BM Black Max iMRI
XM XMax iMRI
Latex-free Certification
Products not made with natural rubber latex.
Anspach Pneumatic Systems User’s Manual DePuy Synthes Power Tools 7
AutoLube III Operating Instructions
(for Black Max and XMax)
Assembly Procedures of AutoLube III
and Handpiece
AUTOLUBE III Foot Control
For additional part numbers, refer to the “Ordering
Information” section.
1. Remove the red plug (installed for shipping only) from the
recirculating bowl located on the top of the AutoLube III.
2. Turn the silver handle located on the back of the AutoLube
III to the “OPEN” position.
3. While maintaining the handle in the “OPEN” position,
insert the muffler end of the pneumatic handpiece into
the cavity located on top of the recirculating bowl.
4. Insert the muffler until the red ring on the muffler cannot
be seen.
5. Rotate silver handle to the “LOCK” position. Check for
secure engagement.
1
Red Plug/
Recirculating Bowl
Oil Fill Cap
Pressure
Gauge
2
Open Position
Operating Pressure
Anspach pneumatic handpieces run on air or medical
grade nitrogen. Standard operating pressure is 90– 120 psi
(6.2 – 8.3 bar). If more or less power is desired, the psi may
be regulated between 40 and 140 psi (2.8 and 9.6 bar).
1. Connect the air hose from the AutoLube III to the hospital
air source, nitrogen tank or hospital nitrogen system.
2. Adjust the air source until the desired air pressure registers
on the gauge of the AutoLube III. Pressure will not register
on the AutoLube III until the muffler is inserted and the
foot pedal is activated.
3. The wall / nitrogen tank pressure may read as much as
40 psi higher than the AutoLube III gauge.
Silver
Handle
3
4
Red Ring inserts
fully into
Recirculating Bowl
Note: Handpiece is fully functional at this time.
Special Operating Pressures for Attachments:
B-ORANGE-45 run at 40 psi (2.8 bar)
B-ORANGE-90 run at 40 psi (2.8 bar)
5
Special Operating Pressures for Dissection Tools:
SIL-DS-A run at 70 psi (4.8 bar)
SHD-DS-A run at 70 psi (4.8 bar)
8 DePuy Synthes Power Tools Anspach Pneumatic Systems User’s Manual
Locked Position
AutoLube III Operating Instructions
Assembly Procedures of AutoLube III and Handpiece
Pressure Relief Valve
Pressure Relief Valve
Note: Handpiece hose may include a pressure relief
valve to remove excess pressure in the case of hose
occlusion between the AutoLube and the valve. If the
pressure relief valve is actuated during use, remove the
source of the occlusion. Do not attempt to disassemble
the pressure relief valve.
AutoLube Lubrication
OIL-II
Instrument Oil with 1 Replacement Filter
Note: The AutoLube III has been delivered without oil
or a filter installed. A bottle of Anspach lubricating oil,
filter, and muffler have been shipped with the unit and
must be added to the AutoLube III prior to use.
1. Before adding oil, disconnect the AutoLube III from the
air source.
2. Remove Oil Fill Cap from the top of the AutoLube III and fill with Anspach lubricating instrument oil (OIL-II).
Do not fill above the “MAX” oil level line next to the oil
reservoir. Always replace the oil fill cap securely. One full
bottle of Anspach lubricating oil should be added when the
oil level reaches the “MIN” oil level line etched next to the
oil reservoir.
Turn handle
to open position
to insert muffler
Oil Fill Cap
Oil Reservoir
AutoLube III Lubrication
1.
2.
4.
5.
3.
Max. Oil Level
Min. Oil
Level
Anspach Pneumatic Systems User’s Manual DePuy Synthes Power Tools 9
AutoLube III Operating Instructions
Assembly Procedures of AutoLube III and Handpiece
AutoLube Lubrication continued
AutoLube III Filter
3. Before each use, a visual check of the oil reservoir should
be made to ensure there will be an adequate supply of oil
to circulate throughout the procedure.
4. Install filter and muffler following “AutoLube III
Filter” section.
Vented Cover
Note: Always store and transport AutoLube III in an
upright position.
AutoLube III Filter
FILTER-IIAutoLube II and III Filters (5/pkg.)
The filter, muffler filter, and vented cover have been packed
separately in the AutoLube III box. The filters should be
changed each time a bottle of Anspach lubricating oil is added.
Insert filter with a
downward motion
1. Insert the filter by taking the tab and sliding the “horseshoe”
shaped portion of the filter into the cavity in a downward
motion. The tab will extend out of the cavity.
2. Push muffler filter into vented cover with the hole in muffler
filter centered over the attachment screw. The muffler is
oversized and must be compressed to fit.
3. Place the vented cover over the filter cavity and secure
by turning the grey wingnut in a clockwise direction.
Filter
Vented Cover
11 DePuy Synthes Power Tools Anspach Pneumatic Systems User’s Manual
Black Max Operating Instructions
Black Max Handpiece BM
BLACKMAX-NHandpiece, Fixed/Straight
BLACKMAX-N-LPLow Pressure Handpiece, Swivel Angle
Attachment
Connection
Lever
Operation
Motor Housing/
Handpiece
Caution: Firm control of the Black Max must be
maintained at all times. Never force the dissection tool.
Let the instrument do the cutting. Never use the
attachments as a retractor to bend or pry.
Only Anspach Black Max dissection tools should be used
with the Black Max.
Distal End
Warning: Always use continuous irrigation to prevent
heat build-up.
Always wear safety glasses.
Black Max Directional Features
The words “SECURE” and “RELEASE” engraved on the side
of the Black Max handpiece refer to the locking and unlocking
the attachment onto the handpiece.
Release
Cutter
The Lever, located on the top of the handpiece, is used to
lock and unlock dissection tools within the handpiece.
Lock
Cutter
Caution: If the dissection tool is not inserted properly,
the Lever will not secure the dissection tool. Do not
force the Lever. For instructions on attachment
assembly, refer to the specific instructions for each
attachment in this manual.
The location of the lever determines the lock and
release of the cutter.
Anspach Pneumatic Systems User’s Manual DePuy Synthes Power Tools 11
XMax Operating Instructions
The XMax Handpieces XM
XMax
XMax-H XMax Handpiece
XMax ­­Handpiece, High Strength Hose
Operation
Caution: Firm control of the handpiece must be
maintained at all times. Never force the dissection tool.
Let the instrument do the cutting. Never use the
attachments as a retractor to bend or pry.
Only Anspach XMax dissection tools should be used with
the XMax.
Warning: Always use continuous irrigation to prevent
heat build-up.
Directional
Arrows
Distal End
Always wear safety glasses.
XM
XMax Directional Arrows
Proximal End
Attachment
Connection
Figure 1
Notice the directional arrows and printing on the distal end
of the handpiece housing: “RUN” ( ), “LOAD” ( ) and
“SAFE.” These terms refer to locking and unlocking the
attachment and dissection tool onto the handpiece (Figure 1).
For instructions on attachment assembly, refer to the
specific instructions for each attachment in this manual.
11 DePuy Synthes Power Tools Anspach Pneumatic Systems User’s Manual
Knurled
Knob
Motor Housing/
Handpiece
iMRI Instrument System
iMRI Instrument System
IMRI-MOTOR
IMRI-FOOT-CTRL
IMRI-SHORT
IMRI-SHORT-HD
IMRI-CRANI-A
IMRI-OIL
Testing of iMRI System as established by ASTM F2213-02
“Standard Test Method for Measurement of Magnetically
Induced Torque on Passive Implants in Magnetic Resonance
Environment” and F2052-02 “Standard Test Method for
Measurement of Magnetically Induced Displacement Force
on Medical Devices in Magnetic Resonance Environment”
confirm there is no detectable magnetically induced torque
on handpiece at 1.5 Tesla (when tested in a 1.5T magnet)
and only slight deflection force (10° with 18% of force due
to gravity) when subjected to a high field strength and high
field gradient location (1.5 Tesla) when tested in a Siemens
1.5T Magnetom Symphony, Maestro Class Unit.
iMRI
iMRI Motor
iMRI Air Control
iMRI Short Attachment
iMRI Short HD Attachment
iMRI Crani-A Attachment
iMRI Synthetic Oil
For additional components, refer to page 40.
Use, Care, and Operating Instructions
Warning: Do not use any attachments or dissection
tools with iMRI handpiece not manufactured by Anspach,
or not identified as “iMRI.” Do not operate handpiece
without attachment and dissection tool installed.
Read and understand thoroughly before operating your
new iMRI Instrument System. Failure to do so could lead to
injury to you or your patient or cause severe damage to
this equipment.
The iMRI Instrument System is a design modification of the
Anspach microMax System. Refer to the “XMax Operating
Instructions” section for additional assembly instructions.
iMRI System and dissection tools are constructed of materials
that permit intraoperative use in an intraoperative magnetic
resonance imaging unit rated at 1.5 Tesla or less and only
when intraoperative magnetic resonance imaging is not
being used for actual imaging purposes.
Caution: Do not use in intraoperative magnetic
resonance imaging units rated at greater than 1.5 Tesla.
Remove iMRI System from intraoperative magnetic
resonance imaging volume during imaging. Failure
to do so could result in unacceptable image noise
and /or distortion.
iMRI System is designed for surgical procedures typically
involving no more than 15 minutes of continuous (actively
drilling) operation. If a procedure is expected to last longer,
you should be aware handpiece speed and temperature may
be affected.
Normal speed of iMRI System will be less than XMax due to
magnetic effects and because iMRI System does not have
continuous oiling. The lower speed will not adversely affect
your ability to perform procedure and you will experience
little to no magnetic pull on handpiece during use. However,
the following effects may be noted:
1. Handpiece speed will slow when handpiece rotating
mechanism is held 90° to magnetic field.
2. Handpiece temperature will increase when handpiece
is held in 90° position for greater than 5 minutes.
Handpiece should not become uncomfortably warm
during normal use; procedures lasting greater than
15 minutes could cause handpiece temperature to rise.
3. Lock mechanisms of iMRI System and dissection tools are
essentially the same as XMax. However, to help prevent
unintended use of non-iMRI devices, geometry has been
slightly modified to prohibit attachment of non-iMRI
handpiece compatible devices.
Anspach Pneumatic Systems User’s Manual DePuy Synthes Power Tools 11
iMRI Instrument System
iMRI Instrument System
iMRI
continued
Caution: Attempts to attach components other than
iMRI System accessories to iMRI handpiece could result
in significant damage to iMRI Handpiece.
Straight attachments should be used for no more than 10
procedures. Craniotome attachments should be used for no
more than five procedures. Attachments are not repairable and
should be replaced after the recommended number of uses.
Metal component parts of iMRI handpiece and attachments,
and all iMRI dissection tools are constructed of materials
mostly unaffected by magnetic properties of iMRI. However,
these materials have significantly less hardness, which directly
affects durability. Proper use, cleaning, maintenance, and
preoperative inspection will help ensure safe use and prolong
useful life of iMRI handpiece and attachments. Periodic
routine servicing by Anspach is strongly recommended.
iMRI dissection tools will dull more quickly than standard
dissection tools because they are manufactured of nonmagnetic
reactive material. Use with iMRI only. During surgical use, you
should remain cognizant of cutter performance and have
additional dissection tools available at all times. Continued
use of dull dissection tools, in addition to possible necroses,
may put additional stress on attachment and handpiece,
leading to premature failure of those devices. Before each
use, assemble system and test to ensure proper performance.
Proper system performance is usually indicated when there
is no unusual difficulty in attaching attachments and dissection
tools, and when system operates at full speed (unloaded with
dissection tools attached) with no unusual noise, vibration,
wobble, or whipping.
Caution: Carefully inspect handpiece and attachments
postcleaning and again preoperatively to ensure there is
no corrosion or remaining debris which could adversely
affect operation or lead to attachment bearing failure
during use.
Continued use of damaged or worn handpiece or attachments
can lead to bearing (or other) failures, which can result in
foreign debris entering surgical wound site. Never reprocess
or reuse iMRI dissection tools. iMRI dissection tools must be
properly disposed of after a single use.
11 DePuy Synthes Power Tools Anspach Pneumatic Systems User’s Manual
iMRI Instrument System
iMRI Operating Instructions
Caution: Do not run handpiece without dissection tool
and attachment installed.
1. Foot control must be placed on floor within reach
of surgeon. Foot control is not subject to sterilization
so should never be placed such that sterile field
is compromised.
2. Place three (3) drops of IMRI-OIL into muffler end of iMRI
handpiece hose assembly. Do not exceed three (3) drops.
Caution: iMRI OIL is for use with iMRI handpiece only.
Do not use with other Anspach “AutoLube” systems.
iMRI OIL used in AutoLube can damage the sight
window, resulting in oil leakage.
3. Connect muffler end of hose to foot control and inspect
handpiece to ensure it is “iMRI” and that internal aspect
of handpiece is free of damage or debris.
Caution: Do not run handpiece without dissection tool
and attachment installed. Damage to handpiece may
result if handpiece is operated without dissection tools
and attachment installed.
4. Select appropriate attachment. Inspect for any signs of
corrosion or damage and ensure it is “iMRI.” Attach
attachment to handpiece and turn clockwise to lock
onto handpiece. Verify locking by pulling on attachment.
5. Select appropriate dissection tools and following all
established sterile techniques, remove it from its packaging,
insert it into and through attachment, into handpiece and
lock into place. Verify locking by pulling on dissection tools.
If using craniotome, dissection tool should be put into
handpiece first, then put craniotome over dissection tools.
6. Attach iMRI foot control to air (or nitrogen) supply. Fully
depress foot pedal and adjust supply air pressure such
that gauge on foot control indicates 120 psi.
7. With handpiece in intraoperative magnetic resonance
imaging field but away from patient, fully depress foot
control and assess handpiece for noise, vibration, wobble,
and whipping. If assembly was without difficulty and
handpiece sounds and feels right, initiate or continue
with use.
8. During procedure, continuously assess cutting effectiveness.
Though iMRI dissection tools are designed to cut effectively,
they are constructed of a much softer metal than standard
(non-iMRI) Anspach dissection tools which you may be
accustomed to. Because of material softness, iMRI dissection
tools will dull more quickly. If you notice a reduction in
cutting effectiveness, stop and replace dissection tools.
Warnings
• Do not reprocess or use reprocessed dissection tools.
iMRI dissection tools are constructed of stainless
steel that is subject to dulling and possible distortion
during initial use. Reprocessors may not be able to
reprocess dissection tools to their original design
condition and reuse could result in excessive whipping
or vibration that could cause severe patient injury
including death. Reprocessed dissection tools may
also be duller than new dissection tools, resulting in
less effective use and possible overheating causing
necrosis of tissues and/or surgeon discomfort.
• Continued use of dull dissection tools can cause user
to apply greater pressure while cutting, which can
seriously damage attachment, and possible bearing
failure. Bearing failure can result in foreign debris
entering surgical wound site.
• iMRI craniotome is constructed of a softer metal than
a non-iMRI craniotome and excessively applied force
will cause craniotome leg/foot to bend or fracture.
Do not bend attachment or use craniotome as a lever.
Do not force dissection tools. Forceful side load may
cause dissection tools fracture, which could cause
injury. It can also result in handpiece speed reduction
and increased temperature.
9. During surgical procedure, when iMRI is used for actual
imaging, remove iMRI System and dissection tools from
imaging volume.
Anspach Pneumatic Systems User’s Manual DePuy Synthes Power Tools 11
Black Max Standard Attachments
and Dissection Tool Assembly
Black Max Dissection Tool Identification
All dissection tools are packaged sterile, unless otherwise
indicated, and are manufactured for single use. Each dissection
tool has a series of identification numbers and letters imprinted
on the label and on the shaft. The first group of letters and
numbers designate the part number, the second group of
letters and numbers designate the lot number. Each attachment
is laser-marked with its corresponding part number.
Black Max Straight Attachments
Refer to “Ordering Information” section for part numbers.
1. Lift Lever on handpiece. Align notch on attachment with
“RELEASE” on side of Black Max handpiece. Turn
attachment so notch is aligned with word “SECURE.”
2. Insert dissection tool into attachment. Return Lever on
Black Max handpiece to down position.
3. Pull dissection tool to ensure proper engagement.
4. Adjust air source until desired air pressure registers on
AutoLube gauge.
Notes
• The operating pressure for these attachments is
40 psi (2.8 bar).
• Handpiece is now fully functional.
The first group of upper case letters of the dissection tool
part number correspond to the attachment’s color-coded
ring and/or name and the last digit represents the dissection
tool style.
For example:
Black Max Dissection Tool Part Number: SIL-8
Dissection Tool Description: #8 style dissection tool used
with the B-SILVER attachment.
B-SILVER
B-TURQUOISE
B-VIOLET
Notes
• Air pressure will not register until foot pedal
is depressed.
• Handpiece is now fully functional.
B-BLUE-S
The operating pressure is 120 psi (8.3 bar), as indicated on
the AutoLube gauge, when using these attachments, except for
those specified in “AutoLube III Operating Instructions” section.
B-GREY-MIA16
Black Max Contra and Right Angle Attachments
B-RED
B-MRA-S, B-MRA-M,
B-MRA-L
B-TURQ-L
B-BLACK
B-ORANGE-45 Contra Angle Attachment (Multiple Angle)
B-ORANGE-90 Right Angle Attachment (90°)
1. Lift Lever on handpiece. Align notch on attachment with
“RELEASE” on side of Black Max handpiece. Turn
attachment so notch is aligned with word “SECURE.”
2. Push latch on the distal end of the attachment up with your thumb.
3. Insert dissection tool into the side of the distal end (opposite
side of latch) while rotating slowly until dissection tool seats.
4. 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.
B-ORANGE-90
B-ORANGE-45
11 DePuy Synthes Power Tools Anspach Pneumatic Systems User’s Manual
Black Max Standard Attachments and Dissection Tool Assembly
Black Max Craniotome and Specialty Attachments
B-TURQ-X
Refer to “Ordering Information” section for part numbers.
1. Lift Lever on Black Max. Insert dissection tool into handpiece.
Return Lever to down position. Pull dissection tool to ensure
proper engagement.
2. Slide attachment over dissection tool. Align notch on
attachment with word “RELEASE” on the Black Max. Next
turn attachment so notch is aligned with word “SECURE.”
3. The handpiece is now operational. Operating pressure is
120 psi (8.3 bar), as indicated on the AutoLube gauge,
when using these attachments.
B-GOLD
B-GREEN
B-GREEN-R
B-GREY-ADG
B-TURQ-CDA
B-QD8
Black Max QD Angle Attachments
Refer to “Ordering Information” section for part numbers.
1. Lift Lever on Black Max. Align notch on angle attachment
with word “RELEASE” on the side of the Black Max.
Next, turn angle attachment so notch is aligned with word
“SECURE” which is laser etched on the side of the Black Max.
2. Pull down retaining sleeve on angle attachment and rotate
to left when attachment is pointed away from you.
3. Insert dissection tool.
4. Release retaining sleeve by rotating to right.
5. Pull dissection tool to ensure proper engagement.
6. Return Lever on Black Max handpiece to down position.
B-QD11
B-QD14
Note: Handpiece is now fully functional.
Operating pressure is 120 psi (8.3 bar), as indicated on the
AutoLube gauge, when using these attachments.
Anspach Pneumatic Systems User’s Manual DePuy Synthes Power Tools 11
XMax Standard Attachments
and Dissection Tool Assembly
Straight Attachment Assembly
Handpiece (XMax)
Retaining Sleeve
Straight Attachment
Dissection Tool
Craniotome Attachment Assembly
Handpiece (XMax)
Retaining Sleeve
Dissection Tool
Dissection Tool Identification
All dissection tools are packaged sterile, unless otherwise
indicated, and are manufactured for single use. Each
dissection tool has a series of identification numbers 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.
For example:
Dissection Tool Part Number: S-2B
Dissection Tool Description: 2 mm Fluted Ball for
Short attachment
Each attachment is laser-marked with its corresponding
part number.
11 DePuy Synthes Power Tools Anspach Pneumatic Systems User’s Manual
Craniotome Attachment
XMax Standard Attachments and Dissection Tool Assembly
Straight Attachments
SHORT
SHORT
5 cm Short Attachment
MEDIUM
8 cm Medium Attachment
LONG
11 cm Long Attachment
MIA16
16 cm Minimally Invasive Attachment
SHORT-HD
5 cm Heavy Duty Short Attachment
MEDIUM-HD
8 cm Heavy Duty Medium Attachment
LONG-HD
12.4 cm Heavy Duty Long Attachment
XL-HD20.2 cm Heavy Duty Extra Long
Attachment
MEDIUM
LONG
MIA16
SHORT-HD
MEDIUM-HD
XM
Assembly for handpieces with
and
.
LONG-HD
Distal end of handpiece or attachment is pointed away
from user.
XL-HD
1. Move handpiece knurled knob to “RUN” ( ) position.
2. Slide attachment over distal end of handpiece. Pull
attachment towards handpiece, and rotate attachment
to right approximately one quarter turn until fully seated.
Handpiece knurled knob moves up to seat next
to attachment.
3. Pull handpiece knurled knob towards “LOAD” ( )
position and insert dissection tool into distal end of
attachment. Rotate dissection tool slowly until
fully seated.
4. Release handpiece knurled knob into “RUN” ( ) 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. Rotate attachment to left approximately one quarter turn,
and remove from distal end of handpiece.
Anspach Pneumatic Systems User’s Manual DePuy Synthes Power Tools 11
XMax Standard Attachments and Dissection Tool Assembly
Orange 45° or 90° Contra and Right Angle Attachments
ORANGE-45
ORANGE-90
ORANGE-45
45° Contra Angle Attachment
90° Right Angle Attachment
Caution: Set AutoLube operating pressure to 40 psi
(2.8 bar).
ORANGE-90
XM
Assembly for handpieces with
and
.
1. Ensure knurled knob on handpiece is in “RUN” ( )
position.
2. Slide attachment over distal end of handpiece. Push
attachment towards handpiece, and rotate attachment
counterclockwise 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 clockwise and remove from distal end
of handpiece.
22 DePuy Synthes Power Tools Anspach Pneumatic Systems User’s Manual
XMax Standard Attachments and Dissection Tool Assembly
Craniotome and Specialty Attachments
CRANI-P
CRANI-A
CRANI-L
CRANI-A-R
ADG
CDA
CRANI-P
6.5 cm Pediatric Craniotome
6.5 cm Adult Craniotome
7.5 cm Large Craniotome
6.5 cm Rotating Adult Craniotome
7.2 cm Adjustable Drill Guide
6.8 cm Controlled Depth Attachment
XM
Assembly for handpieces with
CRANI-A
CRANI-L
CRANI-A-R
and
.
Distal end of handpiece or attachment is 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.
ADG
CDA
Note: Handpiece is now fully functional.
3. Pull dissection tool to ensure proper engagement.
4. Slide attachment over distal end of handpiece. Pull
attachment 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. Rotate attachment to left approximately one quarter turn,
and remove from distal end of handpiece.
3. Remove dissection tool from distal end of attachment.
Anspach Pneumatic Systems User’s Manual DePuy Synthes Power Tools 22
XMax Standard Attachments and Dissection Tool Assembly
QD Angle Attachments
QD8
QD8
QD11
QD14
QD11
8 cm Quick Disconnect Angle Attachment
11 cm Quick Disconnect Angle Attachment
14 cm Quick Disconnect Angle Attachment
XM
Assembly for Handpieces with
and
.
Distal end of handpiece or attachment is pointed away
from user.
QD14
1. Move handpiece knurled knob to “RUN” ( ) position.
2. Slide attachment over distal end of handpiece. Pull
attachment towards handpiece, and rotate attachment
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 Power Tools Anspach Pneumatic Systems User’s Manual
Minimal Access Attachments
and Dissection Tool Assembly
Note: Instructions are the same for straight or
angled drivers and for straight or curved bearing
sleeves in 10 cm, 15 cm, and 19 cm lengths. The four
words labeled on the drivers mean the following:
CUTTER Insert or remove dissection tool
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
MA-D20
MA-DRIVER
Warning: The Minimal Access Attachments are to
be used only for delicate bone dissection applications.
Excessive force or side loads during use can cause
rapid temperature increase at the distal end of the
attachment. Always use copious irrigation with
this attachment.
MA-D20BM
20° Angle Driver (for Black Max)
MA-D20
20° Angle Driver (for XMax)
MA-DRIVERStraight Driver (for XMax)
BM Black Max 20° Angle Driver Installation
1. Ensure locking lever is up.
2. Align notch on BM 20° angle driver with “RELEASE” arrow
on handpiece while inserting driveshaft of BM 20° angle
driver into handpiece. Rotate BM 20° angle driver to right
until notch is aligned with “SECURE” arrow on handpiece.
Push locking lever down to locked position.
3. Gently twist back and forth to ensure driver is locked
into position.
XM
XMax Driver Installation
1. Ensure handpiece is in “RUN” ( )
2. Insert driveshaft of driver into distal end of handpiece,
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.
Anspach Pneumatic Systems User’s Manual DePuy Synthes Power Tools 22
Minimal Access Attachments and Dissection Tool Assembly
Bearing Sleeve and Dissection Tool Assembly (BM 20°
Angle Driver, 20° Angle Driver, or Straight Driver)
MA-10SBearing Sleeve, 10 cm Straight
MA-10CBearing Sleeve, 10 cm Curved
MA-15SBearing Sleeve, 15 cm Straight
MA-15CBearing Sleeve, 15 cm Curved
MA-15STBearing Sleeve, 15 cm Straight Taper
MA-19STBearing 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.
Bearing Sleeve Adjustment
1. Rotate knurled knob on driver to line up arrow with “ADJUST.”
2. Pull 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. Rotate knurled knob on driver to line up arrow with
“TUBE.” Remove bearing sleeve distal end of driver.
BM
Driver Removal for Black Max
1. Driver removal is reversal of installation instructions.
XM
Driver Removal for XMax
1. Move handpiece knurled knob to “SAFE” position.
2. Rotate attachment to left approximately one quarter turn,
and remove from distal end of handpiece.
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. Rotate knurled knob on driver to line up arrow with
“CUTTER.” Remove dissection tool from distal end
of attachment.
22 DePuy Synthes Power Tools Anspach Pneumatic Systems User’s Manual
microSaws and Small Attachments Assembly
The microSaws were designed for small bone dissection.
The microSaw Drivers provide direct connection to Black Max
and XMax. The Drivers also enable rapid exchange of saw
head styles through a unique quick-disconnect system.
BM-DRIVER
Keyless Driver Installation
BM Black Max Keyless Driver Installation
BM-DRIVER
DRIVER
Keyless Driver
1. Ensure locking lever is up.
2. Align notch on keyless driver with “Release” arrow on
handpiece while inserting drive shaft of Keyless Driver
into handpiece. Rotate keyless driver clockwise until
notch is aligned with “Secure” arrow on handpiece.
Push locking lever down to locked position.
Disassembly
BM-DRIVER and DRIVER Duty Cycle
30 Sec ON, 30 Sec OFF for 8 cycles.
The recommendations for times of use for the DRIVER
attachments have been determined under average load
and worst case ambient air temperature of 85°F (29°C).
1. Raise locking lever.
2. Rotate BM-DRIVER counterclockwise and remove
from handpiece.
XM
XMax Keyless Driver Installation
DRIVER
Keyless Driver
1. Ensure knurled knob on handpiece is in “Run” or
“Secure” 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.
Disassembly
1. Pull knurled knob down and twist counterclockwise until it
seats into position.
2. Rotate DRIVER counterclockwise and remove.
Anspach Pneumatic Systems User’s Manual DePuy Synthes Power Tools 22
microSaws and Small Attachments Assembly
Oscillating, Sagittal, and Reciprocating Saw
Attachment Assembly
S-SAW
S-SAWSagittal microSaw Attachment
R-SAWReciprocating microSaw Attachment
O-SAWOscillating microSaw Attachment
1. Insert saw attachment drive shaft into distal end of keyless
driver. Rotate until three tabs on attachment engage 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.
R-SAW
O-SAW
Sagittal Saw Blade Assembly
1. Press down on release button to open saw blade
mounting plate.
2. Insert saw blade into opening through slot on mounting
plate and align saw blade hub with locking pins in
mounting plate.
3. Release button and ensure mounting plate is firmly
seated on saw blade without gaps.
Reciprocating Saw Blade Installation
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.
Disassembly
Saw and Small Attachment Removal
1. With one hand supporting attachment, rotate release ring
on keyless driver with other hand counterclockwise until
attachment is released.
Oscillating Saw Blade Assembly
1. Press 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. Release button and ensure mounting plates are firmly
seated on saw blade without gaps.
22 DePuy Synthes Power Tools Anspach Pneumatic Systems User’s Manual
microSaws and Small Attachments Assembly
J-Latch and Keyless Jacobs Chuck Attachment Assembly
SA-JACOBS
SA-JLATCH
SA-JLATCH
Jacobs Chuck
J-latch Chuck
Note: Anspach does not supply dissection tools for
SA-JLATCH or SA-JACOBS small attachments.
Keyless driver refers to either BM-DRIVER or 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. Continue to rotate counterclockwise while pushing
attachment into keyless driver until attachment locks
into position and release ring snaps into position.
3. When fully engaged, contours on keyless driver body,
release ring, and small attachment will be in alignment.
SA-JACOBS
J-Latch Dissection Tool Assembly
1. Pull back distal sleeve in direction of arrow on
SA-JLATCH attachment and hold it down to insert
dissection tool into distal end of attachment.
2. Rotate dissection tool slowly until fully seated.
3. Release distal sleeve and check security of dissection
tool by pulling distally on dissection tool.
4. Dissection tool and attachment are secure.
J-Latch Dissection Tool Removal
1. Pull back distal sleeve in the direction of arrow on
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
Keyless Jacobs Chuck Dissection Tool Removal
1. Press 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. Rotate knurled knob counterclockwise while centering
cutter on attachment until tight; release button.
4. Check security of dissection tool by pulling distally on
dissection tool.
5. Dissection tool and attachment are secure.
1. Press down on center
of release button located
on SA-JACOBS attachment while rotating knurled knob
on attachment clockwise until fully opened.
2. Pull dissection tool out distally for removal.
3. Release button.
Caution: Do not press down on release button while
attachment is in use.
Disassembly
microSaw and Small Attachment Removal
1. W
ith one hand supporting attachment, rotate release
ring on keyless driver or e12 handpiece with other hand
counterclockwise until attachment is released.
Anspach Pneumatic Systems User’s Manual DePuy Synthes Power Tools 22
Handheld Attachments Assembly
Sagittal Saws
B-SAGITTALBlack Max Sagittal Saw
MM-SAGITTALSagittal Saw (for XMax)
The B-SAGITTAL and MM-SAGITTAL operate at 120 psi,
providing 20,000 cycles per minute while it oscillates
through a blade arc of 4 degrees.
BM
Black Max Sagittal Saw Assembly for handpieces with
“SECURE” and “RELEASE”
1. The words “SECURE” and “RELEASE”
engraved on side of handpiece refer to locking
and unlocking attachment on handpiece respectively.
Lift lever on handpiece.
2. Align notch on Sagittal Saw with “RELEASE”
on handpiece.
3. Turn Sagittal Saw so notch is aligned with “SECURE”
on handpiece.
4. Press down lever on handpiece.
5. For B-SAGITTAL, see Blade Assembly.
XM
Sagittal Saw Assembly and Disassembly
.
for handpieces with and
(Distal end of handpiece or attachment is pointed away from
user.)
1. Remove red storage cover. Move handpiece knurled
knob to “RUN” position.
2. Slide Sagittal Saw over distal end of handpiece. Pull
Sagittal Saw towards handpiece, and rotate to right
approximately one-quarter turn until fully seated.
Handpiece knurled knob will move up to seat next
to Sagittal Saw.
3. Sagittal Saw is secure.
4. See Blade Assembly.
Disassembly
1. Move handpiece knurled knob to “SAFE” position.
2. Rotate Sagittal Saw to left approximately one-quarter
turn, and remove from distal end of handpiece.
Blade Assembly (B-SAGITTAL/MM-SAGITTAL)
1. Raise and fully extend extension handle on saw blade
attachment mechanism.
2. Rotate extension handle counter-clockwise to open saw
blade mounting plates.
3. Insert saw blade into opening and align saw hub with
locking pins in mounting plates. Blades can be aligned
in 45 degree increments.
4. Rotate extension handle clockwise to secure saw blade
and lower extension handle into closed position.
22 DePuy Synthes Power Tools Anspach Pneumatic Systems User’s Manual
Handheld Attachments Assembly
Perforator Driver
CSR60BMPerforator Driver with Hudson End
(for Black Max)
CSR60Perforator Driver with Hudson End
(for XMax)
CSR60
This Perforator Driver attachment allows Hudson style
cranial perforators to be used with Black Max and XMax
Systems (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.
Disassembly
1. Move handpiece knurled knob to “RELEASE” position.
2. Rotate Perforator Driver to left approximately
one-quarter turn and remove device.
3. Replace red storage cover.
XM
BM
Black Max Perforator Driver Assembly for handpieces
with “SECURE” and “RELEASE”
Perforator Driver Assembly for handpieces with
.
and
1. Remove red storage cover.
2. Lift lever on handpiece.
3. Slide Perforator Driver over distal end of handpiece until
fully seated. Rotate Perforator Driver to right approximately
one-quarter turn.
4. Press down lever on handpiece.
5. Pull back retaining sleeve; insert Hudson-end of cranial
perforator and release retaining sleeve.
1. Remove red storage cover.
2. Move handpiece knurled knob to “RUN” position.
3. Slide Perforator Driver over distal end of handpiece. Pull
Speed Reducer towards handpiece and rotate to right
approximately one-quarter turn until fully seated. Handpiece
knurled knob will move up to seat next to Perforator Driver.
4. Pull Perforator Driver retaining sleeve towards handpiece.
Insert Hudson-end of cranial perforator and release
retaining sleeve.
Disassembly
1. Lift lever on handpiece.
2. Rotate Perforator Driver to left approximately
one-quarter turn and remove device.
3. Replace red storage cover.
Disassembly
1. Pull Perforator Driver retaining sleeve towards handpiece
and remove cranial perforator from distal end of
Perforator Driver.
2. Move handpiece knurled knob to “SAFE” position.
3. Rotate Perforator Driver to left approximately one-quarter
turn and remove from distal end of handpiece.
4. Replace red storage cover.
Note: The red storage cap provided with the Perforator
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 Pneumatic Systems User’s Manual DePuy Synthes Power Tools 22
Cleaning Instructions
Pneumatic High-Speed Systems
The following manual cleaning and mechanical/automated
cleaning with manual Precleaning instructions have been validated by Anspach for preparing a nonsterile medical
device; this instruction is provided in accordance with ISO
17664:2004 and ANSI/ AAMI ST81:2010.
Contact your Sales Representative for replacement of product
incinerated under this policy or for temporary equipment
while the original equipment is quarantined. Contact the
DePuy Synthes Power Tools Customer Service department
regarding TSE/CJD contamination for additional information.
Warning: Transmissible spongiform encephalopathies
(TSE). DePuy Synthes Power Tools will not authorize or
accept the return of products that directly contact patients
or are contaminated with body fluids of a patient who is
suspected or confirmed with a TSE/ Creutzfeldt-Jakob
disease (TSE/CJD) diagnosis. DePuy Synthes Power
Tools recommends that all Anspach products used on a
patient confirmed with a TSE / CJD diagnosis be incinerated. Anspach
dissecting tools used on a patient suspected of TSE/CJD
diagnosis must be incinerated.
33 DePuy Synthes Power Tools Anspach Pneumatic Systems User’s Manual
Manual Cleaning
High-Speed Handpieces
Detergents
•Neutral pH enzymatic detergents are recommended
for the manual washing of the high speed handpieces.
•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.
Warning: Wear eye protection and any additional
PPE required.
Caution: Do not immerse! Do not insert brush into
handpiece housing. Do not use saline solution for
cleaning. Do not use cleaners containing chlorinated
phenols of any concentration. Using cleaners/
disinfecting agents containing chlorinated phenols
will result in premature hose failure. Do not use
hypochlorite (i.e. bleach) solutions, since these will
corrode metal components. 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.
1
Preparation
Assemble all necessary supplies such as a lint-free cloth.
Remove the attachment and dissection tool from the
handpiece (Figure 1).
2
Clean
Wipe with a clean, deionized, distilled, or purified
water-dampened cloth and mild detergent (neutral pH).
Figure 1
Caution: DO NOT IMMERSE. Handpiece must not
be exposed to ingress of water or to severe physical
trauma; degradation of unit function and / or
performance may occur.
3
Inspect
Visually inspect the handpiece and repeat step 2 until
no visible soil remains.
Anspach Pneumatic Systems User’s Manual DePuy Synthes Power Tools 33
Manual Cleaning
Attachments
Caution: Manual cleaning instructions for all
attachments except the Minimal Access (MA)
attachments and bearing sleeves.
Detergents
•Alkaline detergents with a maximum pH of 11 are
recommended for the manual washing of the attachments.
•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.
Note: “DO NOT IMMERSE” as marked on attachments
is for OR personnel only.
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 and CSR60-BM 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 sterilization
(Figure 2). The cap is used for storage purposes only.
Figure 1
2
Immerse
Fully immerse the attachment in an alkaline cleaner with a
maximum pH of 11 (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 2
33 DePuy Synthes Power Tools Anspach Pneumatic Systems User’s Manual
Figure 3
Manual Cleaning
Attachments
3
Clean Cannulations
Caution: This step refers ONLY to the following
attachments (for other attachments proceed to step 4):
Type of Attachment
Names of Attachments
Straight Attachments
SHORT, MEDIUM, LONG, MIA16, SHORT-HD, MEDIUM-HD, LONG-HD, B-SILVER, B-TURQUOISE,
B-VIOLET, B-BLUE-S, B-MRA-S, B-MRA-M, B-MRA-L, B-TURQ-L, B-BLACK, B-RED
Craniotomes
CRANI-A, CRANI-A-R, CRANI-A-01, CRANI-P, CRANI-L, CRANI-L-R, B-TURQ-X, B-GOLD,
B-GREEN, B-GREEN-R
Specialty Attachments
ADG, B-GREY-ADG, B-TURQ-CDA, CDA
QD Attachments
QD8, QD8-S, QD11, QD11-S, QD14, QD14-S, B-QD8, B-QD8-S, B-QD11, B-QD11-S, B-QD14,
B-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 through the attachment. ACB is to be utilized
once per system set and discarded once the system
cleaning is complete.
4
Figure 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.
Cleaning Instructions for Minimal
Access (MA) Attachments
Minimal Access Drivers (MA-D20, MA-20BM, MA-DRIVER)
Minimal Access Bearing Sleeves (MA-10S, MA-10C, MA-15S,
MA-15C, MA-15ST, and MA-19ST).
Note: Please refer to cleaning instructions provided
with the MA attachments.
Anspach Pneumatic Systems User’s Manual DePuy Synthes Power Tools 33
manual cleaning
foot controls
AutoLube Foot Control
Caution: Do not immerse or sterilize. Do not allow liquid
to enter AutoLube, except as specified in the operating
manual for adding Anspach oil.
1
Clean
clean autolube foot control by wiping with nonabrasive
cloth and disinfectant or mild detergent and water after
each case.
2
Add oil
check oil level and add anspach oil and filter when level
is below “mIn oIl” level line.
3
Store
store in upright position.
iMRI Foot Control
Caution: DO NOT IMMERSE OR STERILIZE!
1
Clean
clean imrI 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.
34
DePuy Synthes Power Tools
Anspach Pneumatic Systems
User’s Manual
manual precleanIng 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.
• XMax-H may not be cleaned automatically.
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).
figure 1
2
Rinse
rinse the handpiece with distal end pointing down under
running cold deionized, distilled, or purified 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 handpiece.
Do not place the hose end under running water.
figure 3
figure 4
distal end
Anspach Pneumatic Systems
User’s Manual
DePuy Synthes Power Tools
35
manual precleaning before mechanical/automated cleaning
high speed handpieces
3
Manipulate Moving Parts
manipulate the handpiece knurled knob under running cold
deionized, distilled, or purified 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 product
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 deionized, distilled, or purified
water for a minimum of two (2) minutes while manipulating
the knurled knob (figures 6 and 7).
figure 6
figure 7
figure 8
figure 9
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 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.
Do not place the hose end under running water. Do not
use pipe cleaners.
36
DePuy Synthes Power Tools
Anspach Pneumatic Systems
User’s Manual
manual precleaning before mechanical/automated cleaning
high speed handpieces
5
Rinse Thoroughly
rinse the handpiece thoroughly under running hot
deionized, distilled, or purified water for a minimum
of 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 inside
of the distal end using a syringe or pipette filled with hot
deionized, distilled, or purified water (figure 12). place the
knurled knob in the “run” position (figure 11).
figure 10
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. Do not place the hose end under
running water.
figure 12
6
Inspect
Visually inspect the handpiece and repeat steps 2 through 6
until no visible soil remains.
Warning: Manual Precleaning must be followed
by mechanical /automated cleaning.
Anspach Pneumatic Systems
User’s Manual
DePuy Synthes Power Tools
37
Manual Precleaning Before Mechanical/Automated Cleaning
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 Access
Bearing Sleeve or attachments not mentioned on page
49 in the EM /XM Cleaning and Sterilization Basket.
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 for
cleaning, washing, and sterilization (Figure 2). Cap
should be used for nonsterile storage purposes only.
Figure 1
Figure 2
Figure 3
Figure 4
2
Rinse
Rinse the attachment under running cold deionized, distilled
or purified 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.
33 DePuy Synthes Power Tools Anspach Pneumatic Systems User’s Manual
Manual Precleaning Before Mechanical/Automated Cleaning
Attachments
3
Manipulate Moving Parts
Manipulate all moving parts such as release sleeves under
running cold deionized, distilled, or purified 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 product
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 bristle brush to remove
all visible soil.
Figure 6
Figure 7
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 attachment (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 to clean the
MA-D20, MA-D20BM 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. The
SDCB may be inserted from the distal or proximal end
of the bearing sleeve.
Anspach Pneumatic Systems User’s Manual DePuy Synthes Power Tools 33
Manual Precleaning Before Mechanical/Automated Cleaning
Attachments
5
Rinse thoroughly
Rinse the attachment thoroughly under running hot deionized,
distilled, or purified water for a minimum of two (2) minutes
(Figure 8). Use a syringe or pipette filled with hot deionized,
distilled, or purified 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
6
Inspect
Visually inspect the attachment and repeat Steps 2 through 6
until no visible soil remains.
Warning: Manual Precleaning must be followed by
mechanical /automated cleaning.
44 DePuy Synthes Power Tools Anspach Pneumatic Systems User’s Manual
Figure 9
Mechanical/Automated Cleaning
Following Manual Precleaning
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 mechanical/ automated cleaning
than manual cleaning. If devices are mechanically
cleaned they must be sent to a DePuy Synthes Power
Tools 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.
Mechanical/ Automated Cleaning Guidelines
DePuy Synthes Power Tools can only be mechanically cleaned
under the following conditions:
•Cannulations must be pre-cleaned with appropriate
brushes as described in Precleaning instructions.
•Devices must not be cleaned using ultrasonic equipment.
•Handpieces must not be immersed in cleaning solution
but may be sprayed with it.
•Fully deionized or purified water must be used during final
rinse to prevent corrosion and spots.
•Devices must be cleaned immediately after use to ensure
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 Pneumatic Systems User’s Manual DePuy Synthes Power Tools 44
Mechanical / Automated Cleaning Following Manual Precleaning
High Speed Handpieces and Attachments
1
Loading the Basket
Load the devices in the basket by securing them in the
appropriate brackets as marked on the basket (Figure 1).
Reference loading configuration pictures on page 49 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).
Figure 1
Figure 2
Figure 3
Figure 4
Caution: Connector ends of electric and pneumatic
handpieces must be sealed with special seal caps
provided (Figure 3).
Note: Before putting on seal cap, turn black cap to
wrap cable tight around it (Figure 4).
2
Mechanical/ Automated Cleaning Cycle Process Parameters
Cycle
Rinse
Duration
(minimum)
2 minutes
Cleaning
Instructions
Cold deionized or purified water
Pre-wash
1 minute
Warm deionized or purified water (≥ 40°C); use detergent
Cleaning
2 minutes
Warm deionized or purified water (≥ 45°C); use detergent
Rinse
5 minutes
Rinse with deionized or purified water
Thermal Processing
5 minutes
Hot deionized 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 if visible soil remains.
Remove seal cap from connector end of handpiece and
drain until no visible droplets are coming from the handpiece
or connector.
44 DePuy Synthes Power Tools Anspach Pneumatic Systems User’s Manual
Inspection and Maintenance
Perform these activities regularly as per institution policy.
Warning: Do not use any damaged equipment. Return
to DePuy Synthes Power Tools repair facility.
Attachments
Straight Attachments
•B-SILVER
•B-TURQUOISE
•B-VIOLET
•B-BLUE-S
•B-MRA-S
•B-MRA-M
•B-MRA-L
•B-TURQ-L
•B-BLACK
•B-RED
Visually inspect for any damage to the tube.
•LONG
•LONG-S
•LONG-01
•LONG-HD
•MEDIUM
•MEDIUM-HD
•MIA16
•SHORT
•SHORT-HD
•XL-HD
Angle Attachments
•B-QD8
•B-QD8-S
•B-QD11
•B-QD11-S
•B-QD14
•B-QD14-S
•MA-D20
•MA-D20BM
•MA-DRIVER
Craniotomes
•B-TURQ-X
•B-GOLD
•B-GREEN
•B-GREEN-R
•CRANI-A
•CRANI-A-R
•CRANI-L
•CRANI-L-R
•CRANI-P
•QD8
•QD8-S
•QD11
•QD11-S
•QD14
•QD14-S
Short
Visually inspect for bent or broken drive shaft.
and for any damage to the tube
QD8
Visually inspect for bent or broken foot.
CRANI-A
Anspach Pneumatic Systems User’s Manual DePuy Synthes Power Tools 44
Inspection and maintenance
Other Attachments
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Visually inspect for overall damage or missing components.
adg
b-grey-adg
b-turQ-cda
b-orange-90
b-orange-45
bm-drIVer
csr60bm
cda
csr60
drIVer
mda
orange-45
orange-90
o-saW
r-saW
s-saW
sa-Jacobs
sa-Jlatch
csr60
Visually inspect for damage to the hose.
Visually inspect for damage to the housing or pedal.
Foot Controls
• all autolube models
44
DePuy Synthes Power Tools
Anspach Pneumatic Systems
User’s Manual
Inspection and Maintenance
Handpiece
•XMax
•XMax-H
•BLACKMAX-N
•BLACKMAX-N-LP
Ensure that the knurl knob operates properly.
•If the knob is hard to turn, it may be lubricated. Please
refer to the instructions for use.
Visually inspect for damage to the silicone hose.
Connect to foot control and operate. The handpiece should
operate smoothly.
•There is no requirement to operate with attachment or
dissection tool.
Anspach Pneumatic Systems User’s Manual DePuy Synthes Power Tools 44
Lubrication
Handpieces
Do not lubricate handpieces.
Attachments
Caution: This step is for attachments only.
1
Immerse in Lubricant
After cleaning and rinsing, fully immerse the attachment
in instrument milk (non-silicone based medical lubricant)
prepared as described on the product label, at room
temperature, in a suitable container and agitate for
15 seconds (Figure 2).
Figure 2
2
Drain
Remove the attachment and allow it to drain until no visible
droplets are coming from it.
Caution: Do not rinse out instrument milk. Do not
apply mineral oil or other lubricants, which may cause
the attachment to overheat.
44 DePuy Synthes Power Tools Anspach Pneumatic Systems User’s Manual
Sterilization
High-Speed Handpieces and Attachments
The following sterilization instruction has been
validated by Anspach in accordance with ISO 17665.
Before sterilizing: Ensure sterilization equipment is in
proper working order as specified by manufacturer. Ensure
equipment manufacturer’s instructions are properly employed
by trained and qualified personnel. Ensure actual cycle
employed has been properly validated for the device(s)/load
configuration being processed and appropriate sterilization
indicator devices are included for each process and cycle.
Caution
• Red protective cap for CSR60 and CSR60-BM must
be removed prior to sterilization (Figure 1). In the
case mechanical/automated cleaning was done in the
EX-BSKT, seals cap from connector end of pneumatic
handpiece must be removed prior to sterilization
(Figure 2).
• Devices must be cleaned prior to sterilization
using the validated cleaning method outlined in
these instructions.
Figure 1
Figure 2
Preparation
Following cleaning and lubrication, load the basket and sterilize
in accordance with the following guidelines.
Load attachments and handpiece in EM/XM Cleaning and
Sterilization Basket by securing them in appropriate brackets
as marked on basket with distal end angled down.
Replace seal cap in its bracket and lay handpiece connector
in bottom of basket.
Secure the lid on the basket.
Anspach Pneumatic Systems User’s Manual DePuy Synthes Power Tools 44
Sterilization
High-Speed Handpieces and Attachments
Package for Sterilization
When wrapping the basket the lid must be used.
Double wrap basket or instruments in accordance with local
procedures, using standard wrap or wrapping techniques
such as those described in ANSI/ AAMI ST79.
Warnings
• You must follow manufacturer’s instructions for any
wraps used.
• Do not use any other sterilization method or cycle
than those listed below which have been validated in
accordance with ISO 17665.
If using the EMAX2-TRAY or XM-CASE or BM-CASE-TRAY:
Method / Cycle
Exposure Temperature
Exposure Time
Minimum Dry Time
Steam Autoclave /Pre-vacuum
(wrapped or unwrapped)
Option 1: 132°C
4 minutes
30 minutes
Option 2: 134°C –138°C
3–18 minutes
30 minutes
Steam Autoclave /Gravity
Air Displacement (wrapped or unwrapped)
Option 1: 132°C
15 minutes
30 minutes
Option 2: 132°C –138°C
15–18 minutes
30 minutes
Warning: STERRAD® —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
(wrapped or unwrapped)
Option 1: 132°C
4 minutes
20 minutes
Option 2: 134°C –138°C
3–18 minutes
20 minutes
Steam Autoclave/Gravity
Air Displacement (wrapped or unwrapped)
Option 1: 132°C
15 minutes
15 minutes
Option 2: 132°C –138°C
15–18 minutes
15 minutes
Notes
•• Foot Controls, consoles and irrigation pumps
should not be sterilized.
•• It is required to include the drying cycle to avoid
possible adverse effects caused by exposure
to residual moisture.
•• Metal devices, tools and equipment are constructed
of materials unaffected by normal environmental
conditions of current standard sterilization means,
when proper operational techniques are employed.
•• Effectiveness of sterilization equipment or sterilization
processes are directly dependent upon numerous
factors beyond DePuy Synthes Power Tools’ control
including among other things; sterilization means,
processes and wrapping techniques employed, brand,
model and condition of sterilization equipment, care
and maintenance techniques employed and operator
knowledge and experience.
•• D
ePuy Synthes Power Tools cannot anticipate all
possible equipment, processes and/or conditions
that may be encountered. The suggested operation
conditions are to be considered as a starting point
for determination of the overall process capability,
without regard for type or condition of equipment
used or methods, techniques or practices employed
by user. Use of proper sterilization indicator devices
is strongly recommended. It is recommended that a
drying cycle be included to avoid possible adverse
effects caused by exposure to condensation.
44 DePuy Synthes Power Tools Anspach Pneumatic Systems User’s Manual
loadIng confIguratIon
hIgh-speed handpIeces and attachments
seal cap
(when not in use)
csr60
seal cap installed
on connector end
of handpiece.
short
medIum
ma bearing sleeves (excluding
ma19-st)
emaX2plus
or Xmax
long
ma-d20
mIa16
Qd8
long-hd
Qd11
cranI-p
Anspach Pneumatic Systems
medIum-hd
cranI-a
User’s Manual
short-hd
cranI-l
DePuy Synthes Power Tools
49
Troubleshooting
Pneumatic Handpieces (Black Max and XMax)
Problem
Possible Cause
Solution
Lack of power or excessive handpiece noise
• Inadequate lubrication
• Inadequate operating pressure
• Muffler not connected properly
• Handpiece hose damaged
• Faulty internal component
• Pressure Relief Valve activated
•Add OIL-II to AutoLube.
•Check pressure on AutoLube. Extra long extension hose
from air source could reduce operating pressure.
•Check Schrader connection.
•Check for handpiece hose occlusion.
•Check connection between muffler and AutoLube
Muffler must be inserted past red line.
•Return to DePuy Synthes Power Tools for service.
•Return to DePuy Synthes Power Tools for service.
•Check for handpiece occlusion, remove the source of the
occlusion. Return to DePuy Synthes Power Tools for service.
Handpiece does not rotate
when foot pedal is activated
•
•
•
•
Handpiece stalling
Faulty attachment
Handpiece lock engaged
Faulty internal component
•Rotate dissection tool, then activate foot pedal.
•Clean or replace attachment.
•Unlock handpiece.
•Return to DePuy Synthes Power Tools for service.
Handpiece vibration or
extremely hot
• Inadequate lubrication
• Handpiece out of balance
• Add Anspach oil to AutoLube.
•Return to DePuy Synthes Power Tools for service.
Excessive vibration of dissection tool
• Dissection tool may be bent
•Replace with new dissection tool.
• Dissection tool may not be fully seated •Reassemble dissection tool and attachment.
• Improper attachment and •Only use correct dissection tool with appropriate
dissection tool combination attachment.
• Possible attachment bearing damage •Return attachment to DePuy Synthes Power Tools for service.
Black Max Lever will not lower
• Dissection tool not seated properly
• Debris built up inside handpiece
•Reassemble dissection tool and attachment.
•Remove attachment, lift lever, and tap distal tip of
handpiece against hard surface until debris is dislodged.
• Broken dissection tool in handpiece •Lift lever, tap distal tip of handpiece against hard surface
until dissection tool is dislodged.
XMax knurled knob
• Dissection tool not seated properly •Reassemble dissection tool and attachment.
will not secure
• Debris built up inside handpiece
•Remove attachment and tap distal tip of handpiece
against hard surface until debris is dislodged.
• Broken dissection tool in handpiece •Remove attachment and tap handpiece against
hard surface until dissection tool is dislodged.
Attachment is hot
• Debris lodged inside attachment
• Possible bearing damage
•Clean attachment using Anspach attachment
cleaning instructions located in this manual.
•Return attachment to DePuy Synthes Power Tools for service.
Craniotome attachment is bent • Excessive force used in operation
•Do not use, replace attachment.
Inoperative foot control
• Oil leaking out of AutoLube
• Faulty air connection
• AutoLube was sterilized or submerged in fluids
• Water in the AutoLube
•Replace AutoLube filter, check oil level.
Do not overfill AutoLube.
•Check connection at air source.
•Return to DePuy Synthes Power Tools for service.
•Return to DePuy Synthes Power Tools for service.
55 DePuy Synthes Power Tools Anspach Pneumatic Systems User’s Manual
Ordering Information
XM
XMax Attachments
Black Max Attachments
SHORT
5 cm Short Attachment
MEDIUM
8 cm Medium Attachment
LONG
11 cm Long Attachment
LONG-S
10.5 cm Long Attachment
LONG-01
10.5 cm Long Attachment, Non-tapered End
MIA16
16 cm Minimally Invasive Attachment
SHORT-HD
5 cm Heavy Duty Short Attachment
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
ADG
7.2 cm Adjustable Drill Guide
CDA
6.8 cm Controlled Depth Attachment
CRANI-A
6.5 cm Adult Craniotome
CRANI-A-01
6.5 cm Adult Craniotome, Thin
CRANI-P
6.5 cm Pediatric Craniotome
CRANI-L
7.5 cm Large Craniotome
CRANI-A-R
6.5 cm Rotating Adult Craniotome
CRANI-L-R
7.5 cm Large Rotating Craniotome
MA-DRIVERStraight Driver
MA-D20
20° Angle Driver
MA-15SBearing Sleeve, 15 cm Straight
MA-15CBearing Sleeve, 15 cm Curved
MA-15STBearing Sleeve, 15 cm Straight Taper
MA-19STBearing Sleeve, 19 cm Straight Taper
MA-10SBearing Sleeve, 10 cm Straight
MA-10CBearing Sleeve, 10 cm Curved
ORANGE-45
45° Contra Angle Attachment
ORANGE-90
90° Right Angle Attachment
QD8
8 cm Quick Disconnect Angle Attachment
QD8-S7.5 cm Quick Disconnect Angle Attachment
QD11
11 cm Quick Disconnect Angle Attachment
QD11-S
10.5 cm Quick Disconnect Angle Attachment
QD14
14 cm Quick Disconnect Angle Attachment
QD14-S
13.5 cm Quick Disconnect Angle Attachment
CSR60Perforator Driver with Hudson End
DRIVER
Keyless Driver
MM-SAGITTALSagittal Saw
O-SAWOscillating microSaw Attachment
R-SAWReciprocating microSaw Attachment
S-SAWSagittal microSaw Attachment
SA-JACOBSSmall Attachment, Jacobs Chuck
SA-JLATCHSmall Attachment, J-Latch
B-SILVER
6.1 cm Attachment
B-TURQUOISE
5.9 cm Attachment
B-VIOLET
8.2 cm Attachment
B-BLUE-S
11.25 cm Attachment
B-TURQ-L
12.6 cm Attachment
B-GREY-MIA16 16 cm MIA
B-BLACK
19 cm Attachment
B-RED
26.65 cm Attachment
B-MRA-S
9.4 cm Revision Attachment
B-MRA-M
16.5 cm Revision Attachment
B-MRA-L
22 cm Revision Attachment
B-ORANGE-45Contra Angle Attachment (Multiple Angle)
B-ORANGE-90Right Angle Attachment (90°)
B-GREY-ADG
8.7 cm Adjustable Drill Guide Attachment
B-TURQ-CDAControlled Depth Attachment B-GOLDLarge Craniotome
B-GOLD-RRotating Large Craniotome
B-GREENStandard Craniotome
B-GREEN-RRotating Green Craniotome
B-TURQ-XPediatric Craniotome
B-QD8
8 cm Angle Attachment
B-QD8-S
7.5 cm Angle Attachment
B-QD11
11 cm Angle Attachment
B-QD11-S
10.5 cm Angle Attachment
B-QD14
14 cm Angle Attachment
B-QD14-S
13.5 cm Angle Attachment
MA-D20BM
20° Angle Driver
MA-15SBearing Sleeve, 15 cm Straight
MA-15CBearing Sleeve, 15 cm Curved
MA-10SBearing Sleeve, 10 cm Straight
MA-10CBearing Sleeve, 10 cm Curved
MA-15STBearing Sleeve, 15 cm Straight Taper
MA-19STBearing Sleeve, 19 cm Straight Taper
B-SAGITTALBlack Max Sagittal Saw
BM-DRIVER
Keyless Driver
O-SAWOscillating microSaw Attachment
R-SAWReciprocating microSaw Attachment
S-SAWSagittal microSaw Attachment
CSR60BMPerforator Driver with Hudson End
SA-JACOBSSmall Attachment, Jacobs Chuck
SA-JLATCHSmall Attachment, J-Latch
Anspach Pneumatic Systems User’s Manual DePuy Synthes Power Tools 55
Ordering Information
iMRI
IMRI Instrument System
IMRI-MOTOR
iMRI Handpiece
IMRI-FOOT-CTRL
iMRI Air Control
IMRI-SHORT
iMRI Short Attachment
IMRI-SHORT-HD
iMRI Short HD Attachment
IMRI-CRANI-A
iMRI Crani-A Attachment
IMRI-S-4B
4 mm Fluted Ball
IMRI-S-1004TD1 mm x 4 mm Twist Drill w/Stop
IMRI-S-1R
1.4 mm x 12.8 mm Fluted Router
IMRI-A-CRN
1.85 mm x 16 mm Fluted Router
IMRI-SHD-6B
6 mm Fluted Ball
IMRI-S-8NS-M3 mm Fluted Matchstick,
extends 8.9 mm less
IMRI-OIL
iMRI Synthetic Oil
Irrigation System
IRRIGATE-TUBESterile Tubing and Hoseclips
IRRIGATE-TUBE-HFHigh Flow Sterile Tubing and Hoseclips
IRR-CLIP-10
Irrigation Clip for SHORT
IRR-CLIP-20
Irrigation Clip for QD8, QD8-S, B-QD8
IRR-CLIP-30
Irrigation Clip for SHORT-HD, B-SILVER
IRR-CLIP-40
Irrigation Clip for MEDIUM-HD, LONG-HD, B-BLUE-S, B-VIOLET
IRR-CLIP-50
Irrigation Clip for MEDIUM, LONG, LONG-S, B-TURQ-L
IRR-CLIP-60Irrigation Clip for QD11, QD11-S, QD14, QD14-S, B-QD11,
B-QD11-S, B-QD14, B-QD14-S
BM XM
Pneumatic Handpieces
BLACKMAX-NSwivel/Angle Handpiece
BLACKMAX-N-LPLow Pressure Swivel/Angle Handpiece
XMax
XMax Handpiece
BM XM
Pneumatic Accessories
ACBAttachment Cleaning Brush
SDCBSmall Diameter Cleaning Brush
AL-III-IRR-MA7Foot Control for Irrigation System, MA7 Adapter
AUTOLUBE-IIIFoot Control
AUTOLUBE-III-DISSFoot Control, DISS Adapter
AL-III-DISS-20Foot Control with 20’ Hose,
DISS Adapter
AUTOLUBE-III-FGFoot Control with Foot Guard
AUTOLUBE-III-FG7Foot Control with Foot Guard,
MA7 Adapter
AUTOLUBE-III-IRRFoot Control for Irrigation System
AUTOLUBE-III-MA7Foot Control, MA7 Adapter
AUTOLUBE-III-NKAutoLube/Foot Control with Nitrogen Keyed Adapter
AUTOLUBE-III-20Foot Control with 20’ Hose
AL-III-30Foot Control with 30’ Hose
AL-III-DISS-30Foot Control with 30’ Hose,
DISS Adapter
FILTER-IIAutoLube II and III Filters (5/pkg.)
OIL-IIInstrument Oil w/1 Replacement Filter for AutoLube -II and -III
HOSE
20-Foot Air Extension Hose
HOSE-5
5-Foot Air Extension Hose
HOSE-10
10-Foot air Extension Hose
HOSE-10-DISS10-Foot Air Extension Hose with DISS Adapter
HOSE-15-DISS
15-Foot Air Extension Hose with
DISS Adapter
HOSE-20-DISS20-Foot Air Extension Hose with DISS Adapter
HOSE-DISS10-Inch Air Extension Hose with DISS Adapter
B-CASE-TRAYSterilization Case with Tray
MM-CTR-RACKCutting Burr Rack
XM-CASESterilization Case with Tray
PGPistol Grip for Black Max
SCHRADER-FSCHRADER Adapter, Female
55 DePuy Synthes Power Tools Anspach Pneumatic Systems User’s Manual
Limited Warranty and Disclaimer: The Anspach Effort, Inc. products are sold with a limited warranty to the
original purchaser against defects in workmanship and materials. Any other express or implied warranties,
including warranties of merchantability or fitness, are hereby disclaimed. Please contact Customer Service
for full Warranty statement.
WARNING: In the USA, this product has labeling limitations. See package insert for complete information.
CAUTION: USA Law restricts these devices to sale by or on the order of a physician.
To order in the US, call DePuy Synthes Power Tools Customer Service: (800) 327-6887.
not all products are currently available in all markets.
Manufacturer
The Anspach Effort, Inc
4500 riverside drive
palm beach gardens, fl 33410
usa
tel: (800) 327-6887
fax: (561) 627-1265
email: infopowertools@dpyus.jnj.com
.
www.depuysynthes.com
© depuy synthes power tools, a division of doI 2013. all rights reserved.
J11813-b 11/13 19-0021a
Anspach Europe Ltd.
aston court, Kingsmead business park
frederick place, high Wycombe
hp 11 1la, united Kingdom
telephone: +441 494 616126
fax: +441 494 616001