Phaco Handpiece&

Harmonic Scalpel

Design, Care and Repair

7

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

8

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

4

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

2

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

handpieces continued…OMS Series 4

Chiron Catalyst Alcon 10,000

OMS Series 3

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 NeoSoniX

Same handpiece that functions on the

Legacy system

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

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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

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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

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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

22

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.

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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.

Phaco Handpiece&

Harmonic Scalpel

Design, Care and Repair

Questions and Discussion