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Mada Sigma Series Operation Manual

Laser stent and tube cutter
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Sigma Laser Stent
And Tube Cutter
OPERATION MANUAL
990-401 REV A

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  • Page 1 Sigma Laser Stent And Tube Cutter OPERATION MANUAL 990-401 REV A...

  • Page 2: Revision Record

    Copyright © 2015, Amada Miyachi America, Inc. The engineering designs, drawings and data contained herein are the proprietary work of AMADA MIYACHI AMERICA INC. and may not be reproduced, copied, exhibited or otherwise used without the written authorization of AMADA MIYACHI AMERICA INC. Printed in the United States of America Revision Record Revision...

  • Page 3: Table Of Contents

    CONTENTS Page Revision Record ............................ii Contents .............................. iii Contact Us ..............................v CDRH Compliance Statement ........................v Safety Precautions ............................. vi Warranty .............................. xi Section I. Description ..........................1 Introduction ............................1 Section II. Installation And Setup ......................3 Uncrating The System .........................3 System Installation And Testing ......................3 Section III.

  • Page 4: Contact Us

    CONTACT US Thank you for purchasing a Amada Miyachi Sigma Series Fiber Laser Tube Cutter. Upon receipt of the Tube Cutter, please thoroughly inspect it for shipping damage before you install it. If there is any damage, contact the shipping company immediately to file a claim, and notify Amada Miyachi America at: Amada Miyachi America Inc.

  • Page 5: Safety Precautions

    SAFE use. Procedures described in this manual must be performed as detailed by qualified and trained personnel. NOTE: For the rest of this manual, all models of the Sigma Series Fiber Laser Tube Cutter will simply be referred to as “the Tube Cutter,” as it is commonly known except in specific instances where unique descriptions are required such as specifications, connections, etc.
  • Page 6 Before using this equipment, read the carefully to understand the correct usage of the Safety Precautions equipment.  These precautions are given for the safe use of the Tube Cutter and for prevention of injury to operators or others.  Be sure to read each of the instructions, as they are all important for safe operation.
  • Page 7 Never expose eyes or skin to laser irradiation. Exposure to direct or scattered laser light is extremely hazardous. Direct exposure of the eye to laser beams may result in blindness. WARNING Wear protective glasses. Be sure to wear protective glasses while using the Tube Cutter. Even with eye protection, you may lose your sight if you look directly at the laser beam.
  • Page 8 CAUTION Keep water and water containers away from the Tube Cutter. Water spilled on the Tube Cutter can cause a short circuit, electrical shock, or fire. Use proper tools (wire strippers, pressure wire connectors, etc.) for terminations of the connecting cables. Do not nick the wire conductor.
  • Page 9 Guidelines for Normal Use Appoint a Laser Safety supervisor. Ensure that the supervisor has as much expertise and experience with lasers and laser equipment as possible. The supervisor, who will be in charge of the laser key switch, is responsible for familiarizing users with safety issues and for coordinating laser welding.
  • Page 10 WARNING Always wear protective goggles when maintaining the Tube Cutter. Goggles must have an optical density of at least 7+, at a wavelength of 1060-1150 nanometers for the operation of the Tube Cutter. 10. For more consistent performance, allow the unit to thermally stabilize for approximately 10 to 30 minutes before use.
  • Page 11 LIMITED WARRANTY 1. (a) Subject to the exceptions and upon the conditions set forth herein, Seller warrants to Buyer that for a period of one (1) year from the date of shipment (“Warranty Period”), that such Goods will be free from material defects in material and workmanship.
  • Page 12 (g) All expendables such as electrodes are warranted only for defect in material and workmanship which are apparent upon receipt by Buyer. The foregoing warranty is negated after the initial use. (h) Subject to Section 1(e) and Section 1(f) above, with respect to any such Goods during the Warranty Period, Seller shall, in its sole discretion, either: (i) repair or replace such Goods (or the defective part) or (ii) credit or refund the price of such Goods at the pro rata contract rate, provided that, if Seller so requests, Buyer shall, at Buyer’s expense, return such Goods to Seller.

  • Page 13: Warranty

    Exhibit A Warranty for “Specialty Products” Limited Warranty EXCEPT FOR THE WARRANTY SET FORTH BELOW IN THIS EXHIBIT A, SELLER MAKES NO WARRANTY WHATSOEVER WITH RESPECT TO THE GOODS (INCLUDING ANY SOFTWARE) OR SERVICES, INCLUDING ANY (a) WARRANTY OF MERCHANTABILITY; (b) WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE;...
  • Page 14 Seller further warrants that all Services performed by Seller’s employees will be performed in a good and workmanlike manner. Seller’s sole liability under the foregoing warranty is limited to the obligation to re- perform, at Seller’s cost, any such Services not so performed, within a reasonable amount of time following receipt of written notice from Buyer of such breach, provided that Buyer must inform Seller of any such breach within ten (10) days of the date of performance of such Services.

  • Page 15: Section I. Description

    SECTION I. DESCRIPTION INTRODUCTION The Sigma Laser Stent and Tube Cutter is a uniquely designed tube cutting system for the production of various implantable medical devices as well as having the flexibility for the production of any small diameter tube designs. However, as with any manufacturing equipment it has its limitations. When used properly it is a reliable, safe system with multiple safety features.
  • Page 16 DANGER Danger from electrical shock, burns, cuts, and various other physical damages are present during the installation process. If the installer has any questions he/she should contact Amada Miyachi America technicians for answers prior to proceeding with the installation. Prior to working with the Tube Cutter the operator must be fully aware of the following potential hazards to operator and others around the system.

  • Page 17: Section Ii. Installation And Setup

    SECTION II. INSTALLATION AND SETUP UNCRATING THE SYSTEM Inspect the crate for any physical damage from shipping. Photograph and document any damage. Report and damage to the responsible individual . When removing the system from the crate make sure the fork lift forks are past the back of the system.
  • Page 18 5. Use an M16 wrench on the four (4) leveling legs, and level the system, in both the side to side, and back to back direction.   SIGMA LASER STENT AND TUBE CUTTER 990-401  ...
  • Page 19 6. Insure and table/axis locks have been removed and there are no obstructions on or around the axis. 7. Locate the main breaker on the facilities panel on the back of the machine, turn the switch off. 8. Connect the systems supplied 3 wire, 8 AWG SOOW cable to the customer supplied 208-240 Volt single phase 40 amp breaker.
  • Page 20 9. Locate the Gas Input on the facilities panel on the back of the machine. 10. Connect regulated 100-120psi to Air Input with 6mm polytube. Make sure the air has water/oil filter trap in line. 11. Connect regulated 50-300psi Oxygen to Assist Gas Input with 6mm high pressure (Festo) tube.
  • Page 21 14. On the computer mounting turn the key labeled operation to the normal position. 15. Press the green computer power button. 16. Again verify there are no objects that could interfere with the movement of the motion system. Using either the supplied "mouse"...
  • Page 22 21. Remove the back panel to easily access electrical connections, wire routing, fiber beam delivery, air, and water hoses. Screenshot of Main Cutting Screen   SIGMA LASER STENT AND TUBE CUTTER 990-401  ...
  • Page 23 22. Locate the GREEN COLLET ( button on the computer screen and press the button labeled You should see the 5C CLOSE. collet close. If there is not a collet installed you will see the blue draw bar move to the left. 23.
  • Page 24 24. Locate the button on the CLAMP computer screen. This is the tooling clamp press the button labeled close. You should hear and see the clamp piston move. NOTE: If there is tooling installed install a piece of correct diameter tubing into the tooling with the clamp closed the tube should be held in place.
  • Page 25 26. Locate the button ASSIST GAS on the computer screen and the ON button. NOTE: You should hear gas coming out of the laser cutting nozzle. By sliding the gas assist bar you should here the pressure increase and or decrease. Cycle these buttons several times to insure operation.
  • Page 26 27. Connect system water supply hose to customer supplied tubing. 28. With the tubing in the 5C collet and through the tooling into the parts catcher close the 5C collet. The tube should now be firmly held in place. 29. Verify that the parts catcher back plug is in place.
  • Page 27 30. Locate the button on the WATER computer screen and press the ON button. You should see water running out of the tube and into the parts catcher and draining out of the parts catcher. By sliding the button on the computer screen you should see the volume of water increase and or decrease as you slide the button.
  • Page 28 32. With a tube in place jog the Z axis until a clear picture appears on the video screen. 33. Locate the key on the computer mounting system labeled LASER and turn it to the ON ENABLE position. 34. With the tube in place under the laser nozzle in the tooling, with the 5C collet closed, with the cutting clamp open, now...
  • Page 29 35. Camera focus and laser focus should be set as coincidental at the factory. That is when the camera displays a clear sharp picture on the video screen the laser should be in or very near optimal focus. To insure this is true, a simple cutoff program can be run to verify this condition.
  • Page 30 39. Run the cutoff program and inspect the edge of the part. It should be straight from top to bottom. If it is angled repeat the above steps. If the cut is larger at the top you may have to slightly raise the Z axis.

  • Page 31: Section Iii. Operation

    SECTION III. OPERATION START UP Before energizing the system verify that there are no foreign objects on the motion system axis such as tools, laser glasses or other materials. Verify that all external connections are in place and ON, such as shop air and gas assist supply. Verify main customer supplied power is ON.
  • Page 32 On the computer mounting turn the key labeled operation to the normal position. Press the green computer power button Again verify there are no objects that could interfere with the movement of the motion system. Using either the supplied "mouse" or the touch screen locate and press the home key. Once the home sequence has completed and all the axis positions read out are at 0.0000.
  • Page 33 12. Attach the cutting bushing to the cutting clamp using the M2.5 pan head and loosely tighten. 13. Bolt the cutting clamp to the cutting block holder using 4 8-32 cap head screws. Insure that the Bellville washer is in place use the tube to be processed to center the clamp and provide clearance for the Bellville washer by placing the tube in the 5C collet and in the cutting collet.
  • Page 34 17. Connect the water supply tubing to the output of the water system to the production tubing. 18. With the tubing loaded into the tooling, close the 5C collet by pressing the button on the computer screen Labeled collet. Cycle the collet several times to verify operation.

  • Page 35: Program Loading

    PROGRAM LOADING Programs use various codes to tell the system when to move, how to move, and what to do when the movement starts and or stops. These codes are called M & G codes. M codes tell the system what to do as an example M16 tells the system to turn on the assist gas.
  • Page 36 Pay attention to the shape as well as the dimensions of the shapes being cut. If the circles are out of round or the square sides are not equal, or if the straight lines are not equal in width it may indicate a problem other than focus.
  • Page 37 Locate the button on the RETURN computer screen to download the program. A new screen will now be displayed, highlight the program that you want to run. Locate the DOWNLOAD SELECTED button and click on it.. The selected program will appear on the editor screen and be displayed on the main cutting screen.
  • Page 38 Once the correct program has been downloaded to the system the operator should proceed as follows: 10. Verify the program is the correct revision and part number 11. Verify the tubing being processed is the correct size and material 12. Load the tubing in the cutting tooling until visible on the video screen. 13.
  • Page 39 15. Remove the processed parts. 16. Close the parts catcher by firmly pushing the parts catcher end into the parts catcher while aligning the alignment notches with the locking buttons. 17. Rotate the parts catcher end to lock in place verifying that the open top part of the parts catcher basket is facing upward.

  • Page 40: M & G Codes

    M & G CODES Insert The Collet Turn the system air pressure ON. Verify that the collet clamping condition is in CLOSED mode. That means the pneumatic clamping cylinder is retracted. Check that no debris is in the spindle nose and on the collet. Insert the collet so the keyway engages the key in the spindle nose.
  • Page 41 Insert the drawbar ( ) to the collet Blue rear thread and turn until it is backing up against the steel snap ring at the thread end of the drawbar tip. Tighten firmly but not excessively. 7. At this position, the collet- drawbar subassembly is fully connected and should have an axial float back-forth of about 1...

  • Page 42: Setting Closing Force - Preload

    Setting Closing Force - Preload With the orange preload knob the disc springs are compressed by turning the knob clockwise. While turning the preload knob, move the tubing slowly back and forth until it is grabbed by the collet and does not move any more. From this point, turn the preload knob with the orange preload wrench another 1/12 of...

  • Page 43: Section Iv. Shut Down Procedures

    SECTION IV. SHUT DOWN PROCEDURES SHUT DOWN PROCEDURES To shut down the system do the following: Press the button on the computer screen. LASER EMISSION 2. Press the button on the computer screen. WATER 3. On the computer mounting turn the laser key to the OFF position. Press the button on the computer screen.

  • Page 45: Appendix A. System Dimensions

    Appendix A. System Dimensions   SIGMA LASER STENT AND TUBE CUTTER 990-401  ...
  • Page 46   SIGMA LASER STENT AND TUBE CUTTER 990-401  ...

  • Page 47: Appendix B. Laser Standards And Classifications

    Appendix B. Laser Standards and Classifications Among the most often asked questions in the laser industry is that of the differences between the various laser standards and classifications. In an effort to provide some clarity on the subject, the following is presented: ANSI The American National Standards Institute (ANSI) is an organization for which expert volunteers...
  • Page 48 Class 3b lasers cannot emit an average radiant power greater than 0.5 Watts for an exposure time equal to or greater than 0.25 seconds or 0.125 Joules for an exposure time less than 0.25 seconds for wavelengths between 0.18 µm and 0.4 µm, or between 1.4 µm and 1 mm. In addition, lasers between 0.4 µm and 1.4 µm exceeding the Class 3a AEL cannot emit an average radiant power greater than 0.5 Watts for exposures equal to or greater than 0.25 seconds, or a radiant energy greater than 0.03 Joules per pulse.
  • Page 49 Class IV laser product means any laser that permits human access during operation to levels of laser radiation in excess of the accessible emission limits contained in Table III-B of 21 CFR Subchapter J Part 1040.10. Class IV levels of laser radiation are considered to be an acute hazard to the skin and eyes from direct and scattered radiation.
  • Page 50 The “M” Classes ** As discussed below in the M Classes Table, a laser product is classified as the "non-M" class when both Conditions 1 and 2 are satisfied, i.e. the measured power is below the AEL (and therefore below the MPE for the eye) even when the measurement requirements reflect the possible use of optical instruments.
  • Page 51 Comparison of Classifications The following charts have been created to illustrate the various similarities and differences between the classification criteria of the different laser standards. Class IEC 60825 (Amend. 2) U.S. FDA/CDRH ANSI-Z136.1 (2000) Class 1 Any laser or laser system containing a laser that cannot emit laser radiation at levels that are known to cause eye or skin injury during normal operation.
  • Page 52 hazard considerations for fire (ignition) and byproduct emissions from target or process materials. Overview of Laser Safety Classes* Class Type of lasers Meaning Relationship to Hazard Area Typical AEL for CW Lasers Class 1 Very low Safe MPEs are not No hazard area 40 µW for blue power lasers or...
  • Page 53 small hazard instruments may be IR, and 5 times the and IR, and 5 potential for exceeded up to 5 limit for Class 2 in times the limit accidental times visible, i.e. 5 mW for Class 2 in exposure visible, i.e. 5 Class 3B Medium power Hazardous when Ocular MPE with...
  • Page 54 Summary of Concept of Subclasses "M" Time Base Class Class -M AEL for Class 1, 100 seconds Generally safe, even for Safe even for intentional exposure or 30000 intentional exposure, for the naked of the naked eye, potentially seconds eye and with optical instruments hazardous for exposure with optical instruments of either category 1 or 2...
  • Page 55             http://www.amy.amada.co.jp/e/    AMADA MIYACHI AMERICA, INC. 1820 South Myrtle Ave., Monrovia, CA 91016, U.S.A.  TEL. +1‐626‐303‐5676  FAX. +1‐626‐358‐8048               http://amadamiyachi.com  AMADA MIYACHI CO., LTD. 200, Ishida, Isehara‐shi, Kanagawa 259‐1196, Japan    AMADA MIYACHI KOREA CO., LTD. 28, Dongtanhana 1‐gil, Hwaseong‐si, Gyeonggi‐do, 445320, Korea  TEL. +82‐31‐8015‐6810  FAX. +82‐31‐8003‐5995  AMADA MIYACHI SHANGHAI CO., LTD. Room01,15th Floor, SML Center, No.610 Xujiahui Road, Huangpu District, Shanghai 200025, China  TEL. +86‐21‐6448‐6000  FAX. +86‐21‐6448‐6550    AMADA MIYACHI EUROPE GmbH Lindberghstrasse 1, DE‐82178 Puchheim, Germany ...
  • Page 56                                                                                  ...

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