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Phaco Emulsification
• Surgical cataract removal procedure
• Number 1 therapeutic surgery for
Americans over 65 years of age. 1.4
million procedures performed each
year.
• Becoming very popular among
veterinarians
History of Phacoemulsification
• Definition: Phaco lens shaped, relating to a lens. From the Greek phakos, lentil (lens), anything shaped like a lentil
• Invented nearly 40 years ago by Dr. Charles Kelman, M.D.
• He received a $280,000 grant and 3 year time limit
• Live cats were used as test animals. Early results were poor and he had blind cats in his basement
• The idea of using ultrasound came to him as he sat in the dentists chair
How does Phaco work?
• Operates on the principle of the Piezoelectric Effect
• PE discovered by Pierre & Jacques Curie in the 1880’s
• When crystals are subjected to an electrical field, they expand and contract in direct proportion to that electrical field
• Converting electrical energy into mechanical energy
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Phaco Procedure• Handpiece primed and tuned
• Small incision in the eye via diamond knife
• Handpiece tip inserted under cornea
• Phaco machine powers crystals in handpiece
• Handpiece tip vibrates ultrasonically thousands of times per second to break up (emulsify) the cataract
• Cataract aspirated and flushed with fluid solution
• Man-made Intra-Ocular lens inserted
Phaco Machine
• Microprocessor controlled
instrument
• Has capability of irrigation,
aspiration, emulsification, cautery,
and cut modes of operation
• Functions can be controlled by
footpedal, remote control, or on the
console
Phaco HandpieceA slim, lightweight, piezo-electric, air-cooled, autoclavable instrument approximately the size of a magic marker
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Phaco Handpiece External
Components
Cord/strain
relief
Aspiration
port
Distal tip
Stainless steel or Titanium
casing/shell
Irrigation
portSerial # etching
Main Internal Component
• Piezoelectric crystal - each handpiece has a
pair or 2 pairs of ceramic crystals, which vary
in size. They resemble thick washers. When
electrified the tip vibrates longitudinally (like a
jackhammer) thousands of times per second.
Crystals are extremely sensitive to changes in
temperature.
There are no moving parts in the handpiece!
Examples of different
handpieces
Bausch & Lomb Millennium Bausch & Lomb Premiere
Alcon 20,000 Legacy AMO Sovereign
Alcon Legacy NeoSoniX
• Alcon’s answer for “Cold Phaco”
• Includes a motor that oscillates the tip as
well as performing the typical jackhammer
effect
• Moisture intrusion again biggest source of
failure
ALCON INFINITI OZIL
• Alcon’s newest phaco hand piece.
• Has additional internal components.
• Alcon’s most expensive exchange.
Alcon Infiniti Ultrasonic
• Functions on the Infiniti phaco system
• Frequency is 40,000 Hz
• An alternative to using the heavy
NeoSoniX or when the doctor does not
want to use the oscillating motion
14
Common Reasons Handpieces
FailIn general, a handpiece will break
down
after approximately 500 procedures• Crystals cracked
• Cord (wire) damage
• Connector damage
• Tip damage
• Jammed needles
• Clogged aspiration port
16
Common Causes of Handpiece
Failure• Sterilization is the number one cause of
failure even when performed properly
– Repeated exposure to heat and pressure causes the crystals to depolarize, or causes breaks in the mold/seals which allows moisture intrusion
– Moisture intrusion will cause electrical failure
– FOLLOW MANUFACTURER’S STERILIZATION AND COOLING INSTRUCTIONS
17
Common Causes of Handpiece
Failure• Rapid Temperature Change
– Not allowed to naturally cool for at least 15 min
– Attempts to expedite cooling can damage crystals
• Mishandling– Dropping, pulling rubber boot loose,
misaligning pins, cutting cord, threading improperly
• Failure to clean– Failure to clear aspiration port
– Build up of debris on connector
19
Repairs
• Only damaged cords, connectors, and shells can
be identified by visual inspection
• For all other problems, the handpiece must be
completely disassembled to evaluate the internal
components to determine cause of failure
• In order to replace any component including the
connector and cord, the entire handpiece must
be taken apart and re-assembled
20
Handpiece Repair
• Complete disassembly including transducer
assembly from outer shell and transducer
• Replaceable parts are discarded
• Remaining parts ultrasonically
cleaned/inspected
• Transducer reassembled using new parts and
tested
• Transducer assembly mated to new tested
connector and cable assembly – tested again
then placed in shell housing
• Autoclaved and re-tested.
21
Tip Repair
• Tip repair only offered on the Alcon 20,000 series models: recessed horn allows access
• Certain models have “reverse thread”
• Users are prone to over-tightening or “cross- threading” the reverse threaded tips
• Area between tip and horn very small and disassembly is the safest way to guarantee all particles removed to prevent going in patient’s eye during a procedure
Ethicon Harmonic Scalpel
repair • Benjamin Biomedical offers repair of all 3
early generations of Ethicon harmonic
scalpel, plus the new Harmonic Blue.
What is a harmonic scalpel?
• Ultrasonic instrument that cuts and cauterizes at the same time- coagulates blood proteins-55,000 Hz
• Operates at a much lower temperature than other instruments- electrical surgical unit (ESU)
• Produces very little if any smoke or charring of tissue- clearer surgical field
• Use improves recovery time of patient
Who uses the harmonic
scalpel?• Harmonic scalpel used in all types of open
and laparoscopic procedures
• Very popular for tonsillectomy
• Ob/Gyn
• Can be used in most cases where ESU is
traditionally used
• Becoming more popular for obvious
reasons
Scalpels vs. Phaco Handpiece
• Scalpels are very similar to phaco
handpiece in technology
• Also works on the piezoelectric effect
• Plugs into the host system via a cable and
multi-pin connector
HARMONIC SCALPELS
• Generation I, obsolete.
• Generation II, diminishing.
• Generation III, most popular.
• Harmonic Blue, newest, growing in
popularity. ( 16 crystals)
What’s inside?
• The scalpel has all of the same type
components as the Phaco handpiece
• Piezoelectric crystals (4)
• Connector
• Cable
• Electrodes
• O-rings, seals
Repair Procedure
• Repair procedure mimics that of the phacos
• Complete disassembly of scalpel: discard cable, connector, crystals, electrodes and o-rings
• Inspect and clean salvaged components ultrasonically: shell, header assembly, horn, etc.
• Complete subassemblies and test each: cable assembly, transducer stack assembly, cable stack assembly, final assembly
• Final test, autoclave and re-test
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Service options
• Manufacturer does not repair. Handpiece or scalpel are replaced
• Repair or exchange– Within two working days from approval of repair
• Emergency exchange– Customer requires handpiece the next day. Send to
customer that night and customer’s broken handpiece is sent in as an exchange
– No loaners available
25
Common Customer
Concerns• Currently using manufacturer
– Possible reasons- quality, safety, ease, bad experience with 3rd parties, does not know alternative exists
– Possible concerns- Price, poor service, being controlled by manufacturer
We provide better service and price without sacrificing quality.
26
Common Customer
Concerns• Handpiece repair may void machine
warranty
– Ask manufacturer rep to show language
in writing or put this statement in writing
– If has statement in writing ask for a copy
– Do not tell them it is against the law or
try to give legal advice.
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Common Customer
Concerns• Why does the handpiece need a full repair if
only 1 part has gone bad?
– Disassembly needed to get to components
– Same wear on each component
• If only my cord/connector is damaged, why can’t we just replace it?
– Cannot solder new wire to old connector
• Only the tip is damaged, why do we need full repair?
– Patient safety, design of handpiece, and repair procedure
– Manufacturer will not do tip repair
Points to Remember
• Most of the time a handpiece must be
disassembled to determine which components
have failed. The machine does not provide a
failure analysis on the handpiece. Only external
damage (cord or tip damage) and certain
connector problems can be detected prior to
disassembly.
• Manufacturers do not trouble-shoot or do minor
repairs. They send out exchange handpieces
• Standard warranty – 90 days failure of
component or due to workmanship
The Benjamin Biomedical
Difference
• All repairs utilize new components
• Cable, crystals, electrodes, connector assembly, o-rings and seals
• Custom made cable w/ Aramid fiber
• We use the same vendors for components as the OEM’s whenever possible
• Unmatched engineering support- lead engineer for Alcon and AMO on staff
• Annually audited Quality System
At Benjamin Biomedical, Quality
Assurance is Key.
• Our quality system is a living, breathing thing. It does not sit on the shelf until audit time. We use it every day.
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