Ensayo de fleccion

Minimagnum Knotless Implant Assy OPERATION : 10
EQUIPMENT:  N/A MATERIALS:
 

P/N MI 220000 Rev. AL Part Type 150 ECN 30107

LINE CLEARANCE

1. Perform line clearance per manufacturing and label line clearance procedure listened in the BOM.

Alcohol 99%. P/N 01158 Wipes P/N 01144

OPERATION : 20
EQUIPMENT:


ANCHOR BODY DEBURR
Select one process only per production order workorder and indicate in the router. This operation of Anchor Deburr can be done with: the Cutting Machine P/N 16323 and/or Manually with the Dumore P/N 26925 . Burr Replacement and Adjustment to the Cutting Machine, call Process Tech or Engineer and use MSF P/N 16323. A. CUT ANCHOR BODY DEBURR WITH EQUIPMENT P/N 16323. Bone Lock (Proximal End): 1. Prior to start of normal production, a completefixture (eight anchors) of process monitoring samples must be measured. This measuring will be executed when any of the following circumstances occurs: a. At the beginning and end of the production order. b. Beginning of the shift (in case that the same WO is been worked more than one day). c. Every new operator. d. After performing adjustments on the cutting machine or changing the tool. 2. All thesamples must be measured after buffing. The units taken must be measured at the wings (Tip area) using optical equipment such as P/N 01644 or 14900. Data recorded must be documented on control ticket. 3. Release tension from Clamp Fixture P/N 16180 by loosening eccentric screw approx. ½ turn (or as needed to achieve maximum distance from Backstop. 4. Clear all burrs from Fixture, 16180 prior toloading Anchors. 5. Load Anchors into Fixture with long Anchor legs to left side. Note: Fixture P/N 16180 must only be used with all 8 anchors in place. Tightening Clamp Fixture P/N 16180 without all 8 Anchors in place will result in damage to the Clamp Fixture. 6. Verify that Anchors are fully seated in Base Fixture. 7. Place downward pressure on Clamp Fixture P/N 16180 while tightening eccentricscrew as shown in the follow picture.

Machine, Anchor Wing Cutter P/N 16323. Fixture, Anchor loading base and gage for wing cutter P/N 16180. SJ-42 F/C BUR 66 TI-A P/N 19927. Artco Burr P/N 16324. Microscope with (6.5X of magnification minimum) P/N 01140 or equivalent. Dumore Grinder P/N 13942. Rio Grande, Polishing Wheel, P/N 27602. Optical comparator P/N 01644 or P/N 14900 or equivalent.

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8. Verify that Clamp Fixture is seated flush against the surface of Base and is not lifted as shown in the follow picture.

MATERIALS:
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Drawings per BOM.

Measure 0- 0.004”

The information contained in this document is proprietary to ArthroCare and may not be used, disclosed, nor copied without written permission of ArthroCare.

05/Mar/12 Effective Datefor MI 220000 Rev. AL

Page 1 of 36

09/18/04 Effective Date for 07409 Rev. B

Minimagnum Knotless Implant Assy OPERATION : 20
EQUIPMENT:
 (CONTINUE)

P/N MI 220000 Rev. AL Part Type 150 ECN 30107

ANCHOR BODY DEBUR
14. Verify with the gage the distance between the Burr and the right side of the fixture, a minimum gap must exist between the gage and the Burr. If you need adjust inthe controller.

8. Clear all chips from Sub-plate, prior to mounting Base. 9. Mount Base, Fixture, 16180 onto Sub-plate, on Machine, Anchor Wing Cutter P/N 16323 by placing vertically over index pins. 10. Verify that Base Fixture, is fully seated on Sub-plate by sweeping left & right edges of Fixture, with Gauge, as shown in the follow picture.

Machine, Anchor Wing Cutter P/N 16323. Fixture,Anchor loading base and gage for wing cutter P/N 16180. SJ-42 F/C BUR 66 TI-A P/N 19927. Artco Burr P/N 16324. Microscope with (6.5X of magnification minimum) P/N 01140 or equivalent. Dumore Grinder P/N 13942. Rio Grande, Polishing Wheel, P/N 27602. Optical comparator P/N 01644 or P/N 14900 or equivalent.

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Minimum Gap

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11. If Gauge, cannot pass over Base, freely...