Phaco harmonic scalpel_12-09[1][1]


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Phaco harmonic scalpel_12-09[1][1]

  1. 1. Phaco Handpiece & Harmonic ScalpelDesign, Care and Repair
  2. 2. 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 7
  3. 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. 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. 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
  6. 6. 4
  7. 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. 8. Phaco Handpiece A slim, lightweight, piezo-electric,air-cooled, autoclavableinstrument approximately the sizeof a magic marker
  9. 9. Irrigation port Serial # etching Distal tipAspirationport Cord/strain Stainless steel or Titanium relief casing/shell Phaco Handpiece External Components 2
  10. 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. 11. Examples of different handpiecesAlcon 20,000 Legacy AMO SovereignBausch & Lomb Millennium Bausch & Lomb Premiere
  12. 12. handpieces continued…OMS Series 3 OMS Series 4Chiron Catalyst Alcon 10,000
  13. 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. 14. Alcon Infiniti NeoSoniXSame handpiece that functions on theLegacy system
  15. 15. ALCON INFINITI OZIL• Alcon’s newest phaco hand piece.• Has additional internal components.• Alcon’s most expensive exchange.
  16. 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. 17. Common Reasons Handpieces FailIn general, a handpiece will break downafter approximately 500 procedures• Crystals cracked• Cord (wire) damage• Connector damage• Tip damage• Jammed needles• Clogged aspiration port 14
  18. 18. 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 16
  19. 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. 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. 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. 22. 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 procedure21
  23. 23. Ethicon Harmonic Scalpel repair• Benjamin Biomedical offers repair of all 3 early generations of Ethicon harmonic scalpel, plus the new Harmonic Blue.
  24. 24. 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
  25. 25. 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
  26. 26. 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
  27. 27. HARMONIC SCALPELS• Generation I, obsolete.• Generation II, diminishing.• Generation III, most popular.• Harmonic Blue, newest, growing in popularity. ( 16 crystals)
  28. 28. 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
  29. 29. 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
  30. 30. 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
  31. 31. 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
  32. 32. 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. 26
  33. 33. 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 26
  34. 34. 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
  35. 35. 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
  36. 36. 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.
  37. 37. Phaco Handpiece & Harmonic ScalpelDesign, Care and Repair Questions and Discussion