Anspach Black Max User manual

lNTRODUCTlON ........................................................................................................................................................................... 1
......................................................................................................................
ASSEMBLY PROCEDURESAUTOLUBE 2
...................................................................................................................................
MOTOR UNITIAUTOLUBE 2
..........................................................................................................................................
OPERATING PRESSURE 2
LUBRlCATlON ................................................................................................................................................................ 3
ASSEMBLY PROCEDURESAUTOLUBE II ................................................................................................................. 4
MOTOR UNllTlAUTOLUBE II ..................................................................................... ........................................ 4
OPERATING PRESSURE .......................................................................................................................................... 4
LUBRICATION ................................................................................................................................................................. 5
...............................................................................................................................
CUTTING BURR IDENTlFlCATlON 6
.....................................................................................................
ATTACHMENTICUTTING BURR ASSEMBLY 6-7
OPERATION ....................................................................................................................................................................................... 7
STERlLllZATlON .............................................................................................................................................................................. 8
CLEANINGAND MAINTENANCE .................................................................................................................................. 9
OPERATING PRESSURES ....................................................................................................................................................... 9
............................................................................................................................................................
TROUBLE SHOOTlNG 10
..................................................................................................................................................
SUMMARY OF CAUTIONS I I
.........................................................................................
BLACK MAX COMPONENTS 8r SPECIFBCATIONS
12
NOTES .................................................................................................................................................................................................. 1 3

The Black Max is a high performance instrument system that operates from 40,000 - 80,000 rpm.
Before usingthe Black Max system,
it is imperative that all individuals worlcing 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. All surgeons operating the Black Max
must be trained

Turn the silver dial on the top of the
AutoLube from"OFF" to"INSERT."
While maintainingthe position of the
dial pointingto"INSERT," slide the
muffler intothe cavity on the front side
of theAutoLube until the red ring on
the muffler cannot be seen. Rotate the
dial back tothe"LOCK position. Check
for secure engagement. See photoA.
The Black Max runs on sterile air or
medical grade nitrogen.Standard operating
pressure is I20
PSI (8.2 bar). Connect the
air hose from theAutoLube tothe air
source.
Adjust the air source until
the desired air pressure registers on
the gauge of theAutoLube.
The
walllnitrogen tank pressure may read as
much as 40 PSI higher than theAutoLube
gauge. Pressurewill not register on the
AutoLube until the muffler is inserted and
the foot pedal
is activated.
CAUTION:Motor is fully functional

NOTE: Always storeAutoLube in an
upright position.
After filling theAutoLube with oil it is
neccesary tochange the filter. Onthe
back of theAutoLube, remove the screws
and the vented cover. Discard the used
filter. Place one newfilter into the cavity
with the blue side facing the vents.
Replace cover and tighten screws.
The filter should be changed each time
you add a bottle ofAnspach lubricating
oil. See photo
D.

Removethe red plugfrom the
recirculating bowl located on the top of
theAutoLube
II. See photoA.Turn the
silver handle located on the back of the
AutoLube
II tothe "OPEN" position.
See photo C page
5. While maintaining
the handle in the"OPEN" position, insert
the muffler end of the motor into the
cavity located on top ofthe Recirculating
Bowl. Insert the muffler until the red
ringon the muffler cannot be seen. See
photo B. Rotate silver handle to the
"LOCKED" position. Check for secure
engagement.See photo C.
The Black Max runs on sterile air or
medical grade nitrogen. Standard
operating pressure is 120 PSI (8.2 bar)
Connect the air hose from the AutoLube
II tothe air source. Adjust the
air source until the desired air
pressure registers an the gauge
of theAutoLube
II. The wall1 nitrogen
tank pressure may read as much as
40 PSI higher than theAutoLube II gauge.
Pressurewill not register on the
AutoLube
II until the muffler is inserted
and the foot pedal is activated.
CAUTION: Motor is fully functional
at this time.

TheAutoLube II has been delivered
without oil or a filter installed. A
bottle ofAnspach lubricating oil
& filter
has been shipped with the unit
and
must be added to theAutoLube Il
prior to use. Before adding oil, you must
disconnect theAutoLube II from the air
source. Remove
Oil Fill Cap from the top
oftheAutoLube II and
fill withAnspach
lubricating oil. Donot
fill above the "Max
Oil Level" line nexttothe oil reservoir.
Always replace the oil
fill cap securely.
One full bottle ofAnspach lubricating
oil should be added when the oil level
reaches the bottom line etched next to
the oil reservoir.
Before each use, a visual check ofthe
oil reservoir should be made to ensure
there will be an adequate supply of oil
to circulate throughout the procedure.
See photo C.
NOTE: Always storeAutoLube II in an
upright position.
The filter and vented cover have been
packed separately in theAutoLube II box.
Insert the filter by taking the tab and
sliding the "horseshoe" shaped portion
of the filter intothe cavity in a downward
motion.The tab will extend out
of the
cavity. See photo
D. Place the vented
cover over the filter cavity and secure by
turning the grey wingnut in a clockwise
direction.
The filter should be chaneed each time
"
you add a bottle ofAnspach lubricating oil.

All cuttingburrs are manufacturedfor single use only and are packaged sterile.The cutting
burrs have a series of numbers and letters imprinted on the shaft. The first set of letters
and numbers designate the lot number.The following upper case letters correspond to the
attachment's color coded ringandlor name and the last digit represents the cutting burr
style. For example the"SIL-8" designates a
#8 style cutting burr that is used with the Silver
attachment.The attachment name is laser engraved on theAttachment tube; B-SILVER.
The words "SECURE" and "RELEASE"
engraved on the side ofthe Black Max
motor refer to lockingand unlockingan
attachment onto the Black Max motor.
Choose an attachment.Align the notch on
attachment with"RELEASE" and turn
attachment so that the notch
is aligned
with "SECURE."The attachmentwill not
disengage from the motor when secured
in this position.See photo
E.
First assemble the attachmentto the
j
motor housing. Nowlock the motor bv
-
- -
I
liftingthe Lever on the motor housing
into the "UP" position. Choose your cutting
burr and insert into attachment. Rotate
the cutting burr slowly while applying
light pressure;feel the cutting burr "seat."
Returnthe Lever to the
"DOWN" position.
Pull on the cuttingburr to ensure engage-
ment.See photo
F.
NOTE: If the cutting burr is not inserted
properly the Lever will not secure
the cutting burr. Donot force
the Lever.

Lock motor by lifting Lever into the "UP" position. Insert the cutting burr into the
motor until the cutting burr
is fully seated. Return Lever tothe "DOWN" position. Pull
on cutting burr to ensure engagement. Slide correspondingattachment over cutting burr
and
"SECURE."
Reverse above procedures for disassembly of cutting burrs and attachments.
Firm control of the Black Max must be maintainedat all times. Never force the cutting
burr;
let the instrument do the cutting. OnlyAnspach cutting burrs should be used with
the Black Max. Always use continuous irrigation toprevent heat build-up. Never use the
attachments
to bend or pry. Always wear safety glasses.

The motor,attachments and irrigation clips may be sterilized with either ethylene oxide or
steam. Ethylene oxide is recommended as
it will significantly prolongthe life of the instrument.
Recommended Sterilization ExposureTimes:
1. STEAMAUTOCLAVE / GRAVITY AIR DISPLACEMENT
270°F+2"F (132"C+ I "C)
20 minutes unwrapped
STEAMAUTOCLAVE I HIGH SPEEDVACUUM
270°F+2"F (132"C+ I "C)
10 minuteswrapped or 8 minutes unwrapped
2. ETHYLENE OXIDE STERILIZATION
I0 : 90 mixture of 600 ETO mg/L
130°F (54°C)
3 Hours
IMPORTANT NOTES:
Sterilization times only represent exposure time and not total cycle time.
.
It is impossible to state exact sterilization protocol due to many variables affecting
sterility. Standard hospital protocol regarding sterilization of power equipment should
be followed.
TheAutoLube & AutoLube I/ should not be sterilized. Wipe clean with a damp cloth
after each surgical procedure. Inthe event of contamination, theAutoLube
& AutoLube II can
withstand
ETO sterilization.

DO NOT IMMERSE!
Prior to sterilization wipe with a clean, damp cloth and use a small brush on the distal
end ofthe motor housingto keep
it clear of debris. Silicone spray may be used on the
hose
to prolong its flexibility and tofacilitate foreign particle removal.
DONOTIMMERSE!
Donot use ultrasound equipment or corrosive or harsh chemical soaps. Wipe with a damp
cloth or rinse with water and
a light detergent. A specially designed brush such as theACB
(Attachment Cleaning brush) available fromAnspach, may be used
to clear debris from the
attachment prior tosterilization.
Do not use a bottle brush within the attachments.
DO NOTIMMERSE!
Wipe clean with a damp cloth after each case. Check oil level and filter as directed on
pages 2
- 5.
Disposable. Single use only.
Standard Operating Pressure
is I20PSI (8.2 bar) If more or less power is desired,
the PSI may be regulated between 40 and 140 PSI.
Operating Pressures for Accessory Attachments
Orange 90: 40 PSI (2.7 bar)
Orange 45: 40 PSI (2.7 bar)
SIL DS-A Cutting Burr: 50 PSI (3.4 bar)

PROBLEM POSSIBLE CAUSE SOLUTION
Lack of power or
Inadequate lubrication AddAnspach oil to theAutoLube
excessive Motor noise
Inadequateoperating pressure Check pressure on the AutoLube.
Extra long extension hose from
air source could reduce operating
pressure
MuffIer not connected properly Check the connection between
the muffler and AutoLube. Muffler
must be inserted past the red line
Motor hose damaged Return toAnspach for service
Defective internal component Return toAnspach for service
Motor does not rotate when
Motor stalling
foot pedal is activated
Rotate cutting burr then activate
I
foot pedal
Defective attachment Clean attachment or replace attachment
Defective internal component Return toAnspach for service
Motor vibration or extremely hot Inadequate lubrication AddAnspach oil to the AutoLube
Motor out of balance Return toAnspach for service
Excessivevibration of cutting burr Cutting burr may be bent Replace with new Black Max cutting burr
Cutting burr may not be fully seated Reassemble cutting burr and attachment
Improper attachment and cutting Only use the correct cutting burr
burr combination with appropriate attachment
Possible bearing damage Return attachment toAnspach for
service
Lever will not lower
Cutting burr notseated properly Reassemble cutting burr and attachment
Debris built up inside motor Remove attachment, lift lever,and tap
motor against hard surface until debris
becomes dislodged
Broken cutting burr in motor Lift lever,tap motor against hard surface
until cutting burr
is dislodged
Attachment is hot Possible bearing damage Return attachment toAnspach for
service
Debris lodged inside attachment Use only an AnspachAttachment
Cleaning Brush to remove debris
Craniotome attachment is bent Excessive force used in operation DoNotUse, replace attachment
Inoperative Foot Control
AutoLube was sterilized or Return toAnspach for service
submerged in fluids
Water in theAutoLube Return toAnspach for service
Oil leaking out ofAutoLube DoNotoverfill AutoLube
4
ReplaceAutoLube filter, Check oil level
Faulty air connection Check connection at air source

operate this equipment unless you have been trained by a certifiedAnspach representative.
fail to check oil level in the AutoLube prior to each use.
cut where you cannot see unless an image intensifier
is utilized. delicate structures in
proximity tothe dissection must be thoroughly protectedto prevent injury.
operate this instrument without the use of safety glasses.
bend the attachments or attempt to use attachment as a lever.Firm control of the
instrument must be maintained at all times.
force the cutting burrs while performing operation. Use agentle tapping motion or side-to-
side motion and letthe instrument do the cutting. Forceful side loading of cutting burrs may
cause fracture of dissectingtool which may cause injury.
autoclavethe AutoLube assembly.
operate the motor with a cutting burr which
is not protected by the appropriate attachment.
Cutting burrs must be adequately retained within motorto prevent distal migration which
may cause injury.
enjoy usingthese instruments.We have manufacturedthem conforming to rigorous quality
standards to provide dependable performance.

BLACKMAX-0 FixedIStraightMotorAssembly
BLACKMAX-N SwivelIAngle MotorAssembly
AUTOLUBE-II
AUTOLUBE-II-FG
AL-FOOTGUARD-1s
OIL-ll
B-OIL
FILTER
FILTER-II
B-CASE-TRAY
ACB
PG
AutoLubeIFoot Control
i
i
AutoLube II with Foot Guard
Foot Guard for AutoLube II
LubricatingOil and Replacement Filter for AutoLube II
LubricatingOil and Replacement Filter for AutoLube I
5/pkg. ofAutoLube I Filters
5lpkg. ofAutoLube II Filters
Sterilization Case withTray
Attachment Cleaning Brush
Pistol Grip for Black Max
B-TURQ-X
B-GREEN
B-GOLD
B-TURQUOISE
6-SILVER
B-VIOLET
B-TURQ-L
B-BLACK
B-RED
B-BLUE-S
Pediatric Craniotome
Standard Craniotome
Gold Craniotome
5.9cm StraightAttachment
6.
l cm StraightAttachment
8.2cm StraightAttachment
12.6cmTapered StraightAttachment
19cm StraightAttachment
26.65cm StraightAttachment
I 1.25cm StraightAttachment
B-SPEED-REDUCER
B-GREY-AD6
B-TURQ-CDA
B-GREY-MIA 1 6
8-GREY-MIA20
B-MRA-S
5-MRA-M
B-MRA-L
B-ORANGE45
B-ORANGE-90
5-QD8
B-QD I I
Perforator Driver
8.7cm Adjustable Drill GuideAttachment
7.4cm Controlled DepthAttachment
16cm Minimally lnvasiveAttachment
20cm Minimally lnvasiveAttachment
9.4cm Micro RevisionAttachment
16.5cm Micro RevisionAttachment
22cm Micro RevisionAttachment
14.3cm ContraAngle Attachment
1 3.8cm RightAngle Attachment
8crn Angled Attachment
II cm Angled Attachment
Operation
Pressure
Speed
Torque
MotorWeight
Motor,Muffler,Hose
Motor Diameter
Length
of Motor
Sterile air or medical grade nitrogen
120 PSI (8.2 bar)
80,000 rpm
9.5 in.oz
(67 N.mm)
3 ozs (85 gms)
1.75 Ibs (794 gms)
.75 in (19mm)
3.5 in (89rnm)