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Surge Canada
  Phaco Handpiece & Harmonic Scalpel



Design, Care and Repair
Phaco Emulsification

    Surgical cataract removal procedure

    Number 1 therapeutic surgery for
    Canadians over 65 years of age.




                                      7
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
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


                                                  8
Phaco Cataract Procedure




                           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 Handpiece
  A slim, lightweight, piezo-electric,
air-cooled, autoclavable instrument
approximately the size of a magic
marker
Irrigation
     port
                  Serial # etching                Distal tip
Aspiration
port


    Cord/strain     Stainless steel or Titanium
    relief          casing/shell




         Phaco Handpiece External
               Components
                                                               2
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
Alcon 20,000 Legacy        AMO Sovereign




Bausch & Lomb Millennium   Bausch & Lomb Premiere
handpieces continued…
OMS Series 3      OMS Series 4




Chiron Catalyst   Alcon 10,000
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
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
                                     14
Common Causes of Handpiece

                       Failure one cause of
     Sterilization is the number
     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                               16
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                 17
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


                                                  19
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.                     20
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
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




                                                          22
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.

                                              25
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



                                               26
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 Medical
            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
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
surgecanada@msn.com

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Phaco Harmonic Scalpel Repair

  • 1. Surge Canada Phaco Handpiece & Harmonic Scalpel Design, Care and Repair
  • 2. Phaco Emulsification  Surgical cataract removal procedure  Number 1 therapeutic surgery for Canadians over 65 years of age. 7
  • 3. 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
  • 4. 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
  • 5. 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 8
  • 7. 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
  • 8. Phaco Handpiece A slim, lightweight, piezo-electric, air-cooled, autoclavable instrument approximately the size of a magic marker
  • 9. Irrigation port Serial # etching Distal tip Aspiration port Cord/strain Stainless steel or Titanium relief casing/shell Phaco Handpiece External Components 2
  • 10. 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!
  • 11. Examples of different handpieces Alcon 20,000 Legacy AMO Sovereign Bausch & Lomb Millennium Bausch & Lomb Premiere
  • 12. handpieces continued… OMS Series 3 OMS Series 4 Chiron Catalyst Alcon 10,000
  • 13. 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
  • 14. Alcon Infiniti NeoSoniX Same handpiece that functions on the Legacy system
  • 15. ALCON INFINITI OZIL  Alcon’s newest phaco hand piece.  Has additional internal components.  Alcon’s most expensive exchange.
  • 16. 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
  • 17. 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 14
  • 18. Common Causes of Handpiece  Failure one cause of Sterilization is the number 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 16
  • 19. 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 17
  • 20. 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 19
  • 21. 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. 20
  • 22. Ethicon Harmonic Scalpel repair  Surge Canada offers repair of all 3 early generations of Ethicon harmonic scalpel, plus the new Harmonic Blue.
  • 23. 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
  • 24. 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
  • 25. 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
  • 26. HARMONIC SCALPELS  Generation I, obsolete.  Generation II, diminishing.  Generation III, most popular.  Harmonic Blue, newest, growing in popularity. ( 16 crystals)
  • 27. 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
  • 28. 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
  • 29. 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 22
  • 30. 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. 25
  • 31. 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 26
  • 32. 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
  • 33. The Surge Canada Medical 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
  • 34. 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.
  • 35. Phaco Handpiece & Harmonic Scalpel surgecanada@msn.com

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