ALGERBRUSH II Operating Instructions Rev 3 April 2012.pdf
Page 1
ALGERBRUSH II
ALGERBRUSH II Operating Instructions
*** Please read the following before operating the ALGERBRUSH II ***
ALGERBRUSH II Operating Instructions
x
The ALGERBRUSH II burr must be sterilized prior to its initial use and following each use thereafter (for
sterilization information, refer to section entitled “Sterilization” )
x
The chuck and burr on the ALGERBRUSH II are held together by friction and may become loose during
shipment. Prior to each use of the ALGERBRUSH II, check the following:
*** Please read the following before operating the ALGERBRUSH II ***
• The ALGERBRUSH II burr must be sterilized prior to its initial use and following each use thereafter
1) Burr fits snugly within the chuck
(for
sterilization information, refer to section entitled “Sterilization” )
2) Chuck fits snugly on the motor shaft
*** Ifchuck
either of
theburr
above
is loose, injury to II
theare
patient
could result
if the assembly
off during
• The
and
onparts
the ALGERBRUSH
held together
by friction
and mayfalls
become
looseuse.
during
Please refer to section entitled “Chuck and Burr Maintenance”
shipment. Prior to each use of the ALGERBRUSH II, check the following:
1)
2)
Burr fits snugly within the chuck
Chuck fits snugly on the motor shaft
*** If either of the above parts is loose, injury to the patient could result if the assembly falls off during use.
Please refer to section entitled “Chuck and Burr Maintenance”
Operation of the ALGERBRUSH II:
x
To start the ALGERBRUSH II, turn end nut in “ON” direction indicated on ALGERBRUSH II label, i.e., to the
right
x
To stop the ALGERBRUSH II, turn end nut in “OFF” direction indicated on ALGERBRUSH II label, i.e., to the
left
*** Note: To ensure ALGERBRUSH II is “OFF”, check that the chuck and burr have stopped spinning.
Operation of the ALGERBRUSH II:
Installation / Changing of Battery:
• Note:
To start
thechanging
ALGERBRUSH
II,should
turn end
nut innot
“ON”
on ALGERBRUSH
***
When
battery, care
be taken
to putdirection
pressureindicated
on the battery
clip as it may breakIIatlabel,
the
to the
right to the motor
pointi.e.,
where
it attaches
x stop
Remove
chuck and burr assembly
entitled “Installation
of Chuck on
andALGERBRUSH
Burr Assembly”) II label,
• To
the ALGERBRUSH
II, turn(see
end section
nut in “OFF”
direction indicated
x
Remove
end
nut
i.e., to the left
x
Slide motor and battery assembly out of housing
***
Note:
To ensure ALGERBRUSH II is “OFF”, check that the chuck and burr have stopped spinning.
x
Battery must be installed - Pole first (next to motor; see ALGERBRUSH II diagram above)
(If battery installed + Pole first, the ALGERBRUSH II will not function properly)
Installation
/ Changing
of Battery:
x
Place
new battery
between motor and battery clip (- Pole next to motor)
x
Re-insert
motor
and battery
assembly
housing
*** Note: When changing battery,
care
should into
be taken
not to put pressure on the battery clip as it may break at the
x
Ensure
motor
seated
properly
in
housing
by
checking the following:
point where it attaches to the motor
1) Motor shaft centered in hole at tip of housing
• Remove
chuck and burr assembly (see section entitled “Installation of Chuck and Burr Assembly”)
2) Tip of motor shaft just even with top of housing
• Remove
endtighten
nut end nut
x
Partially
• Slide
motorif motor
and battery
assemblysee
outsection
of housing
x
Note:
starts spinning,
above entitled “Operation of ALGERBRUSH II” for instructions to
stopmust
motorbe installed - Pole first (next to motor; see ALGERBRUSH II diagram above)
• Battery
(If battery installed + Pole first, the ALGERBRUSH II will not function properly)
• Place new battery between motor and battery clip (- Pole next to motor)
Installation of Chuck and Burr Assembly:
• Note:
Re-insert
and
batterywhen
assembly
into
housing
***
Motormotor
must be
spinning
installing
chuck
and burr assembly to ensure motor seated properly
• Ensure
motor ensure
seated motor
properly
in housing
by checking the
following:
x
To install,
is spinning,
i.e., ALGERBRUSH
II is
“ON”
Gently push
and in
burr
assembly
onto
motor shaft
1) 1) Motor
shaft chuck
centered
hole
at tip of
housing
Baseofofmotor
chuck shaft
shouldjust
be even
close with
to, buttop
notof
touching,
2) 2) Tip
housingtop of housing
3) Turn “OFF” ALGERBRUSH II until ready to use
• Partially tighten end nut
Toifremove,
• xNote:
motor starts spinning, see section above entitled “Operation of ALGERBRUSH II” for
1) Grasp base of chuck with fingers and pull away from motor shaft - or instructions
to stop motor
2) Gently pry chuck off motor shaft with suitable instrument
3)
x
Turn “OFF” ALGERBRUSH II until ready to use
1
Rev: 2, Oct 2009
To replace burr,
1) Remove chuck and burr assembly from motor shaft (per instructions above)
2) While grasping base of chuck with fingers, grasp shaft of burr with Foley hemostat and pull apart
3) To insert new (sterilized) burr, use Foley hemostat to grasp burr (grasp in middle of shaft); then, push
chuck onto bottom of burr shaft until snug Note: burr fits into “longer” end of chuck; see drawing of
chuck and burr on front page of instruction sheet.
Chuck and Burr Maintenance:
*** Chuck and burr assembly are held together by friction; should they become loose or not fit snugly, use the
following procedures to tighten.
x
If base of chuck becomes loose on motor shaft, pinch base of chuck gently with small pliers as shown in
Figure I below (Note: slit in base of chuck should be facing directly away from you)
x
If burr becomes loose in chuck, pinch longer portion of chuck gently with small pliers as shown in Figure II
below (Note: slit in longer portion of chuck should be facing directly away from you)
Sterilization of the ALGERBRUSH II:
********* DO NOT AUTOCLAVE THE ENTIRE INSTRUMENT! IT WILL BE RUINED! *********
ab2instr_rev3_043012.doc
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Rev: 3, April 2012
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Remove chuck and burr assembly from ALGERBRUSH II (per instructions above); Separating burr by itself is
fine, but burrs are small and hard to handle; therefore, it is easier to keep chuck and burr assembly together
Housing can be cleaned by wiping with alcohol
Refer to Appendix 1 for validated sterilization and cleaning procedures
FIG. I
FIG. II
Appendix 1:
Cleaning and Sterilization Instructions
Scope: The following is applicable before initial use and after each subsequent use. Carbide burrs are provided
mechanically clean, but are not sterile (unless labeled “STERILE”). Therefore, carbide burrs should be sterilized
before first use.
Warnings:
Do not use chemical or dry heat to sterilize carbide burrs, as these processes have not been validated for
use
Cleaning agents with chlorine or chloride as the active ingredient are corrosive to stainless steel and must
not be used. Cleaning agents with neutral pH are recommended.
Do not use Cold Sterilizing Methods for the sterilization of burrs. These agents often contain strong oxidizing
chemicals that may dull or weaken burrs.
Do not use enzymatic solutions for cleaning or debriding burrs.
Reprocessing Limitations:
The end of life is determined by wear and damage in use. Carbide burrs should be inspected for defects (i.e.
broken tips, broken sections on flutes, etc.) during the cleaning process.
Point of Use:
Delay in reprocessing must be kept to a minimum to avoid contaminants drying thereby making cleaning
more difficult.
Containment/Transportation:
Carbide burrs can be transported wet or dry and should be protected from damage. If transported wet there
is an increased chance of staining or corrosion. Prolonged storage in disinfectant solutions may result in
degradation of the product and must be avoided.
Ultrasonic Cleaning Procedure:
Prepare a fresh pH-neutral cleaning solution; place the carbide burr in the dedicated instrument block (if
applicable) and then place in a sonication unit. Follow the agent manufacturers' instructions for correct
concentration, exposure time, temperature, and water quality. Completely submerge the device in the
cleaning solution and sonicate for at least fifteen (15) minutes.
Perform a final thorough rinse of the device and instrument block (if applicable) under running warm tap
water for at least (1) minute.
Visually inspect to confirm the removal of debris. Repeat the cycle if needed.
Dry the device using a non-shedding wipe or clean compressed air.
Inspection Testing:
Carefully inspect each device to ensure that all debris has been removed.
Visually inspect the device for damage/ wear that would prevent proper operation:
o Do not use if the tip is broken.
o Do not use if there is a broken section of a flute.
o Do not use if there is evidence of corrosion.
Packaging:
Singly: Pack the carbide burr in pouches validated for sterilization
In Sets: Place the carbide burr in the dedicated instrument block.
Sterilization: Use the following cycle for steam sterilization
Cycle Type
Minimum Sterilization
Exposure Time (minutes)
Gravity
10
Pre-vacuum (4 Pulses)
3
Minimum Sterilization
Exposure Temperature
135°C (275°F)
134°C (273°F)
Minimum Dry Time
(minutes)
30
30
Ensure that the sterilizer manufacturer’s maximum load is not exceeded.
Storage:
The carbide burr should be stored in the sterilization pouch (or instrument block) until required.
Additional Information:
These processes have been validated as being capable of preparing carbide burrs for reuse. Any deviation
from these instructions should be properly validated for effectiveness and potential adverse results.
ab2instr_rev3_043012.doc
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Rev: 3, April 2012