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Ar 6410 coiled into tray - issues
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Ar 6410 coiled into tray - issues

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Transcript

  • 1. AR-6410 Coiled in 12892 Rev 7 Tray
    • Summary:
    • The existing 156” coil design (1561 Rev 2) is not acceptable for packaging the AR-6410 into the Arthrex tray. The coil will need to open up to accomplish optimum fit into tray and minimal product height.
    • Background
    • 10 units of AR-6410 were assembled and packaged into 12892 Rev 7 tray. The 156” coil of this product was made to spec 1561 Rev 2. The fit and overall height was assessed and an improved coiling size was proposed.
    • Note: The 12892 Rev 7 is the AR-6430 tray, with a height of 2.16”. If a tray is used on AR-6410, the the only difference will be in the height: it will be <= 1.75”. It is cost-prohibitive to go taller than 1.75” for AR-6410 tray.
    • Observations:
    • When assembled to the remainder of the AR-6410 product, the tallest component of the product, the drip chamber cap, rests directly onto the tubing coils.
    • The 4.5” tail/luer add-on does not comfortably tuck into the innermost coil.
    • Risks:
    • 1a. Increases overall height of entire tube set. Tray taller  box taller  lose sterilization cube space  increase sterilization costs
    • 1b. Any time a hard component rests on top of soft tubing, there is a risk of kinking, where tubing narrows/flattens and sets.
    • The 4.5” tail/luer add-on can pop out from the coil, risking 1a and 1b.
    • Inputs:
    • Dimension out the optimum/proposed coil size.
    • Redline drawing and then reproduce coil using new drawing dimensions only.
    • Assemble remainder of product to coil. Assess product fit into tray.
    • Repeat 1-3 as needed.
  • 2. 12892 Rev 7 Tray Product Code - Tray Height AR-6430 - 2.16” AR-6410 & 11 - ~1.75” AR-6421&AR-6220 - ~1”
  • 3. Drip Chamber Cap = 1.38” When the AR-6410 is assembled, coiled and stacked, the drip chamber cap is the tallest component.  Drip Chamber
  • 4. 1561 DWG Rev 2 Coil Optimum Coil -There is more space in the tray than is actually being used. -The 4.5”tail/luer doesn’t fit. It could possibly fit if it was changed to 3”. -Space is used well. The tail fits. -We don’t have to change the 4.5” tail to a 3”.
  • 5. 1561 DWG Rev 2 Coil Optimum Coil
  • 6. 1561 DWG Rev 2 Coil Optimum Coil The drip chamber cap rests on top of the tubing. The drip chamber cap rests on the inner surface of the tray.
  • 7. 1561 DWG Rev 2 Coil Optimum Coil
  • 8. 1561 DWG Rev 2 Coil Optimum Coil
  • 9. 1561 DWG Rev 2 Coil Optimum Coil
  • 10. 1561 DWG Rev 2 Coil Optimum Coil -Based on overall product height, we would not be able to use a 1.75” tray. Going deeper than 1.75” is cost-prohibitive and we are better off using the existing pouches. -Based on overall product height, we can use a tray that is 1.75”. Note: The spike components are sticking up in this photo and appear taller than the drip chamber. Ignore that; I did not configure the rest of the product so that they would be flat.

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