Surge CanadaPhaco Handpiece & Harmonic Scalpel

Design, Care and Repair

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Phaco Emulsification

Surgical cataract removal procedure Number 1 therapeutic surgery for

Canadians over 65 years of age.

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

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Phaco Cataract Procedure

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 Handpiece A 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

Irrigationport Serial # 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

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Common Reasons Handpieces Fail

In 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

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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.

Ethicon Harmonic Scalpel repair

Surge Canada 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

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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 Usually this cannot be provided

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 Surge Canada MedicalDifference

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

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

Surge Canada Medical Incwww.surgecanadamedical.com

surgecanada@msn.com