{"id":33,"date":"2018-08-23T01:42:12","date_gmt":"2018-08-23T01:42:12","guid":{"rendered":"http:\/\/engprojects.tcnj.edu\/surgonomic19\/?page_id=33"},"modified":"2019-05-09T01:16:02","modified_gmt":"2019-05-09T01:16:02","slug":"contact-us","status":"publish","type":"page","link":"https:\/\/engprojects.tcnj.edu\/surgonomic19\/contact-us\/","title":{"rendered":"Project Updates"},"content":{"rendered":"

September 8, 2018 <\/span><\/strong><\/h3>\n

The team is working to finalize the requirements & specifications of the device.<\/p>\n

Requirements: <\/strong><\/em><\/p>\n

    \n
  1. Must include a handle shaped comfortably for the hand.<\/li>\n
  2. Handle must allow for different grips. <\/span><\/li>\n
  3. Must maintain an appropriate minimal weight for the surgeon to hold.<\/li>\n
  4. Handle must allow for the attachment of a variety of accessories (i.e. blades). <\/span><\/li>\n
  5. The handle must have a low vibrational frequency while the blade is rotating. <\/span><\/li>\n
  6. Device must produce a rotational speed for the accessories to function.<\/span><\/li>\n
  7. Handle must have a passage for irrigation.<\/span><\/li>\n
  8. The device must be powered.<\/span><\/li>\n
  9. The device must be safe.<\/span><\/li>\n
  10. The device must be sterilizable. <\/span><\/li>\n<\/ol>\n

    September 21, 2018 <\/strong><\/span><\/h3>\n

    The team received IRB approval for the Voice of Customer Survey. <\/p>\n

    October 1, 2018 <\/strong><\/span><\/h3>\n

    The team is considering the following standards: <\/p>\n

      \n
    1. Standards for use of equipment <\/span><\/li>\n
    2. Standard for Orthopedic Devices, Surgical Devices<\/li>\n
    3. Standard for Medical Electrical Equipment<\/span><\/li>\n
    4. Standard for Care and Handling Orthopedic Instruments<\/span><\/li>\n
    5. UL Standard for Safety Medical Electrical Equipment, Part 1: General Requirements for Safety<\/span><\/li>\n<\/ol>\n

      October 15, 2018<\/strong><\/span><\/h3>\n

      The team finalized the specifications for this project. <\/p>\n

      Requirement 1<\/b><\/em>: Handle must be shaped comfortably for the hand.<\/span><\/p>\n

      Specification 1<\/b><\/em>: The diameter of the handle must be between 30-50 mm. <\/span> <\/span>Justification: <\/b>This is the recommended diameter for optimal flexibility and rotation of the instrument.<\/span><\/p>\n

      Specification 2<\/em>: <\/b> <\/span>The device must be able to accommodate at least 2 different hand grips. <\/span>Justification: <\/b>Surgeon must be able to grip the handle at different positions.<\/span><\/p>\n

      Requirement 2<\/em>:<\/b> Device handle must have an acceptable weight for the surgeon to use. <\/span><\/p>\n

      Specification: <\/b><\/em>The weight of the shaver should be less than 19.3 oz. <\/span>Justification: <\/b>Weight of the current Conmed Ergo hand piece is 19.3 oz and VOC indicates this as problematic.<\/span><\/p>\n

      Requirement 3<\/em>: <\/b>The handle must allow for reduced muscle fatigue on the surgeons\u2019 hands when compared to current arthroscopic shaver systems.<\/span>3<\/span><\/p>\n

      Specification 1<\/em>:<\/b> The handle should have a vibrational frequency below 8hz while in use. <\/span>Justification: <\/b>Human body is most sensitive to vibration in the frequency range of 1-8 hz.<\/span><\/p>\n

      Specification 2<\/em>:<\/b> Grip strength values before and after using device will not be significantly different. <\/span>Justification:<\/b> Reduction in grip strength is correlated with observed muscle fatigue.<\/span><\/p>\n

      Requirement 4<\/em>: <\/b>Device must produce a rotational speed for the accessories to function. <\/span><\/p>\n

      Specification<\/em>:  <\/b>Blade must rotate at speeds of 100 – 12,000 RPM.  <\/span>Justification:  <\/b>This is the appropriate RPM range for arthroscopic shavers<\/span>.<\/span><\/p>\n

      Requirement 5<\/strong><\/em>: The temperature observed on the surface in contact with the surgeon\u2019s hand must not harm or cause discomfort. <\/p>\n

      Specification<\/em>:<\/strong> The temperature measured on the external surface of the handle held by the surgeon must not exceed 43.8\u00b0C (110.8\u00b0C).
      \nJustification<\/strong>: This is the heat pain threshold during contact with the hand.<\/p>\n

      Requirement 6<\/em>:<\/b> Handle must allow for the attachment of a variety of accessories (i.e. blades). <\/span><\/p>\n

      Specification 1<\/em>:<\/strong> Joint for the blade must have a diameter between 3.5-6.0mm. Justification:<\/strong> The size of standard shaver blades of Ultracut, used by Conmed, is in this range.<\/p>\n

      Specification 2<\/em>:<\/strong> Blades must fit with a latch mechanism that will transmit the functionality of the device.
      \nJustification:<\/strong> Blades need to be securely attached to device.<\/p>\n

      Requirement 7<\/em> : <\/b>Handle must have a passage for irrigation in which flow can be modulated.<\/span><\/p>\n

      Specification: <\/b><\/em>The output volumetric flow rate must be +\/- 10% of the input setting (between 0 and 1200 mL\/min). <\/span>Justification: <\/b>Minimum and maximum flow rates for shaver suction function of ConMed 24k pump.<\/span><\/p>\n

      Requirement 8<\/em> : <\/b>Surgeon must be able to control irrigation flow and blade operation<\/span>.<\/span><\/p>\n

      Specification 1<\/strong><\/em>: When closed, incoming volumetric flow rate must be 0 mL\/min. When open, the incoming volumetric flow rate must be +\/- 10% the input volumetric flow rate provided by the pump.
      \nJustification:<\/strong> The handle control must completely stop flow when needed, but not impede flow when control is not in use.<\/p>\n

      Specification 2<\/em>:<\/strong> When controller is activated, blade rotation changes to the desired type (forward, backward, oscillation).
      \nJustification:<\/strong> Surgeon must be able to quickly change blade direction based on use.<\/p>\n

      Additional Requirements & Specifications: <\/strong><\/p>\n