AR-6410 Coiled in 12892 Rev 7 TraySummary:• 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:1. 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. 2. 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 costs1b. Any time a hard component rests on top of soft tubing, there is a risk of kinking, where

tubing narrows/flattens and sets.2. The 4.5” tail/luer add-on can pop out from the coil, risking 1a and 1b.

Inputs:1. Dimension out the optimum/proposed coil size.2. Redline drawing and then reproduce coil using new drawing dimensions only. 3. Assemble remainder of product to coil. Assess product fit into tray. 4. Repeat 1-3 as needed.

12892 Rev 7 Tray

Product Code - Tray HeightAR-6430 - 2.16”AR-6410 & 11 - ~1.75” AR-6421&AR-6220 - ~1”

Drip Chamber Cap

= 1.38”

When the AR-6410 is assembled, coiled and stacked, the drip chamber cap is the tallest component.

Drip Chamber

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”.

1561 DWG Rev 2 Coil Optimum Coil

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.

1561 DWG Rev 2 Coil Optimum Coil

1561 DWG Rev 2 Coil Optimum Coil

1561 DWG Rev 2 Coil Optimum Coil

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.