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SIGMA LASER STENT AND TUBE CUTTER 

990-401 

1

 

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.     
The following guidelines are for the installation of the 

Sigma Laser Stent and Tube Cutter

.  For the 

rest of this manual this system will be referred to simply as “

the Tube Cutter

” as it is commonly known. 

 

 

 

 

Содержание Sigma Series

Страница 1: ...990 401 REV A Sigma Laser Stent And Tube Cutter OPERATION MANUAL ...

Страница 2: ...ata 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 EO Date Basis of Revision A N A 4 2015 None Production release ...

Страница 3: ...ction I Description 1 Introduction 1 Section II Installation And Setup 3 Uncrating The System 3 System Installation And Testing 3 Section III Operation 17 Start Up 17 Program Loading 21 M G Codes 26 Insert The Collet 26 Setting Closing Force Preload 28 Section IV Shut Down Procedures 29 Appendix A System Dimensions A 1 Appendix B Laser Standards and Classifications B 1 ...

Страница 4: ...of this manual are subject to change without notice If you have any questions or find any errors or omissions in it please contact us Amada Miyachi America is not responsible for any losses due to improper use of this product CDRH COMPLIANCE STATEMENT The Amada Miyachi America Inc SIGMA SERIES FIBER LASER TUBE CUTTER is certified to be fully compliant with all applicable standards and regulations ...

Страница 5: ...ns arise regarding the proper and SAFE operation of the Tube Cutter Operation When operating or servicing the Tube Cutter always wear Protective Goggles having an optical density of at least 7 at a wavelength of 1060 1150 nanometers for the operation of the Tube Cutter Appoint a Laser Safety Officer The Laser Safety Officer LSO must provide personnel with sufficient training so that personnel can ...

Страница 6: ...e sure to read each of the instructions as they are all important for safe operation The meaning of the words and symbols are as follows DANGER Do not touch the interior of the Tube Cutter when it is turned ON Doing so may result in electric shock Never attempt to disassemble repair or modify the Tube Cutter Doing so may result in electric shock or fire Refrain from any mechanical adjustment other...

Страница 7: ...use electric shock short circuit or fire If any part needs to be repaired or replaced consult Amada Miyachi America or your distributor Stop operation if any trouble occurs If you detect a burning smell abnormal sounds abnormal heat smoke etc from the Tube Cutter turn the power OFF immediately to prevent fire or electric shock Contact Amada Miyachi America or your distributor for help Ground the T...

Страница 8: ...tible materials To avoid the risk of fire never apply the laser to flammable or combustible materials When operating the Tube Cutter do not cover it with a blanket cloth etc Heat generated by the operating Laser may ignite a blanket or cover Do NOT use the Tube Cutter for purposes other than processing metal Use of the Tube Cutter on other materials or in a manner other than specified may cause fi...

Страница 9: ...mist Locations in which the unit may be subject to vibration or impact Locations in which the unit may be exposed to chemicals Locations near sources of high frequency noise or Locations in which condensation may form on the unit s surface 5 If the room temperature changes quickly as when a heater is turned ON in cold weather moisture may condense on the optical components resulting in fogging or ...

Страница 10: ...ize for approximately 10 to 30 minutes before use The appropriate warm up time will depend on the ambient temperature and work piece material Refer to the following standards for more information on managing laser equipment IEC60825 1 Edition1 2 Safety of laser products Part1 Equipment Classifications requirements and user s guide Amada Miyachi America Laser Safety Manual Part Number 990 502 Warni...

Страница 11: ...TY RIGHTS OF A THIRD PARTY WHETHER EXPRESS OR IMPLIED BY LAW COURSE OF DEALING COURSE OF PERFORMANCE USAGE OF TRADE OR OTHERWISE Notwithstanding the foregoing in the event of the failure of any Third Party Product Seller will assist within reason Buyer at Buyer s sole expense in obtaining from the respective third party any if any adjustment that is available under such third party s warranty e Se...

Страница 12: ... 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 i THE REMEDIES SET FORTH IN SECTION 1 H SHALL BE BUYER S SOLE AND EXCLUSIVE REMEDY AND SELLER S ENTIRE LIABILITY FOR ANY BREACH OF THE LIMITED WARRANTY SET FORTH IN SECTION 1 A Represent...

Страница 13: ...ditions for Additional Acceptance Tests either at Seller s or Buyer s facility shall be mutually agreed in writing prior to issuance or acceptance of the Acknowledgement Performance Warranty The system is warranted to pass the identical performance criteria at Buyer s site as demonstrated during final Acceptance Testing at the Testing Site during the Warranty Period as provided in the Acknowledgem...

Страница 14: ...defect in material and workmanship which are apparent upon receipt by Buyer The foregoing warranty is negated after the initial use No warranty made hereunder shall extend to any product whose serial number is altered defaced or removed Remedies With respect to any such Goods during the Warranty Period Seller shall in its sole discretion either repair such Goods or the defective part THE REMEDIES ...

Страница 15: ... 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 The following guidelines are for the installation of the Sigma Laser Stent and Tube Cutter For the rest of this manual this system will be referred to simply as the Tube Cutt...

Страница 16: ...working with the Tube Cutter the operator must be fully aware of the following potential hazards to operator and others around the system All laser systems are strictly classified for safety The Tube Cutter incorporates multiple features to insure that it meets or exceeds those standards The following procedures should only be performed by individuals who are trained and experienced in 1 High volt...

Страница 17: ...ION AND TESTING Different States Cities and Counties may have safety and fire regulations specific to their locations Because of this the customer should verify that the installation instructions meet or exceed local code and safety requirements 1 Move the system to the final location 2 Insure that there is a minimum distance of 2 feet of clearance around the system While 2 feet in the minimum dis...

Страница 18: ...SIGMA LASER STENT AND TUBE CUTTER 4 990 401 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 ...

Страница 19: ...r 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 NOTE Most fire departments require 3 feet of floor clearance around electrical supply panels ...

Страница 20: ...regulated 50 300psi Oxygen to Assist Gas Input with 6mm high pressure Festo tube For cutting it is recommended to use liquid oxygen dewers At a minimum if oxygen cylinders are being used they should be 99 999 purity 12 Locate the main breaker on the facilities panel on the back of the machine turn the switch ON 13 Again insure there are no obstructions on the motion system of any type before movin...

Страница 21: ...d moving all axis position readout should be zero 18 Verify that the customer supplied shop air is ON 19 Verify that the customer supplied assist gas is ON 20 Verify that the systems water supply reservoir tank sight glass is 2 3rds full If required add water to the reservoir to raise the level by removing the hose as shown and adding the required amount of water The systems water supply laser pow...

Страница 22: ...SIGMA LASER STENT AND TUBE CUTTER 8 990 401 21 Remove the back panel to easily access electrical connections wire routing fiber beam delivery air and water hoses Screenshot of Main Cutting Screen ...

Страница 23: ...SE You should see the 5C collet close If there is not a collet installed you will see the blue draw bar move to the left 23 Locate the COLLET OPEN RED button on the computer screen Pressing this button you should see the 5C collet open and or the blue draw bar move to the right Cycle these 2 buttons several times to verify operation ...

Страница 24: ...ing installed install a piece of correct diameter tubing into the tooling with the clamp closed the tube should be held in place Modest pulling pressure on the tube will verify that the clamp is closed 25 Locate the CLAMP OPEN RED button on the computer screen and push to open the clamp If there is a tube in the tooling it should now move freely back and forth Cycle these two buttons several times...

Страница 25: ...ASSIST GAS button 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 ...

Страница 26: ...t 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 ...

Страница 27: ...er 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 31 Locate the WATER button on the computer screen and turn the button OFF The water should stop flowing NOTE There may be a small residue flow for a second or two Cycle these two buttons several times to insure operation ...

Страница 28: ...il a clear picture appears on the video screen 33 Locate the key on the computer mounting system labeled LASER ENABLE and turn it to the ON 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 activate the water ...

Страница 29: ...ll Close the 5C collet Turn the water ON Turn the assist gas ON Set laser parameters Open the shutter Rotate the tube 365 degrees Close the shutter Move the X axis 500 Open the shutter Rotate the tube 365 degrees to cut the piece off 38 Close the laser guard window or put on laser protection goggles Activate the program If you see a large plum of sparks from the surface of the tube try lowering or...

Страница 30: ...ut is larger at the top you may have to slightly raise the Z axis Once you have a straight cut adjust the camera focus for a sharp clear image on the video screen You will have then adjusted laser focus and camera focus to be coincidental 40 Verify light tree is operating properly Red is ON when E Stop is engaged Yellow is ON 2 seconds before laser emits Green is ON when the shutter is open ...

Страница 31: ...y that there are no foreign objects on the motion system axis such as tools laser glasses or other materials 2 Verify that all external connections are in place and ON such as shop air and gas assist supply 3 Verify main customer supplied power is ON 4 Turn the system rear mounted main breaker to the ON position ...

Страница 32: ...te the blue draw bar to tighten the collet in place With the air supply to the 5C collet off if required loosen the 4 set screws on the yellow tension adjustment knob and adjust by rotating clockwise or counter clockwise increase or decrease the amount of travel of the blue draw bar to open or close the 5C collet Refer to the insertion of collet instructions at the end of this chapter for instruct...

Страница 33: ...llet and in the cutting collet 14 While tightening the 4 bolts in a alternate bolt pattern have the X axis moving in a positive and negative motion or by manually moving the tubing in a positive and negative motion NOTE This movement while tightening the 4 cap head screws will insure that the cutting collet clamp and clamp bushing are all concentric 15 Tighten the M2 5 pan head screw in the bushin...

Страница 34: ...eep the tube in place when the X axis is moving back with the collet open so a light pull push is all that is required If required air pressure to the clamp can be increased 22 Locate the ASSIST GAS button on the computer screen Press the button to activate the gas Verify the required pressure Cycle this function several times to insure operation 23 Insure that there are no spots or contaminates d...

Страница 35: ...anual is essential to generate any type of program Understanding the various codes will be helpful Prior to loading the program for the part to be processed the operator should establish laser focus on the size tubing to be processed Using a focus program this finding focus is a simple process 1 First set all laser parameters to the settings for the part to be processed 2 Lower the Z axis until a ...

Страница 36: ...the programmed dimensions If the dimensions are not correct it may mean that the beam diameter is larger or smaller than expected Inspect the edge quality and cut quality for straight walls and smoothness If the walls of the cut are not straight let s say larger at the top than the bottom you may need to raise the Z axis 5 Adjust the focus up or down in small increments 0 0005 in by jogging the Z ...

Страница 37: ... the computer screen to download the program 8 A new screen will now be displayed highlight the program that you want to run 9 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 ...

Страница 38: ...the program are set Once focus has been established the system is ready to produce parts The program should ask a series of questions that require a response from the operator at the beginning of the production program The operator will either press click the YES button or if inputting a numerical answer press click the ENTER button They are Is the tubing loaded in the tooling How long is the tube...

Страница 39: ... catcher basket is facing upward 18 Load a new piece of tubing 19 Make sure the tubing is visible on the screen under the laser nozzle 20 Press start to again run the program 21 Repeat until the number of required parts have been processed NOTE Some companies or customers may require that a number of parts may be required to be visually and dimensionally inspected after processing a given number o...

Страница 40: ...ing condition is in CLOSED mode That means the pneumatic clamping cylinder is retracted 3 Check that no debris is in the spindle nose and on the collet 4 Insert the collet so the keyway engages the key in the spindle nose 5 On the drawbar turn the orange knob counterclockwise until it is fully backed away Use the Blue Locking Pin Handle ...

Страница 41: ...en 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 millimeter 0 040 inch If not then the preload knob needs to be turned further CCW You are ready to insert the tubing stock CAUTION To avoid damaging the equipment do not turn manually or under servo power at this stage of collet insertion adjustmen...

Страница 42: ...o provide a light holding force for the collet NOTES For delicate stock this may have to be reduced to about half 15 For heavy stock tubing large diameter and thick wall and long stock length increase to 60 but in any case less than a 1 4 turn 3 Secure this position of the preload knob by using 2 4 set screws Tighten very lightly to avoid damaging the thread on the drawbar 4 Test the pneumatic cla...

Страница 43: ...ess the GAS ASSIST button on the computer screen 5 Verify there is no tubing loaded in the tooling 6 Verify there are no foreign items on any of the axis such as tools parts or papers 7 Press the HOME key on the computer screen 8 When all the axis have stopped moving and read 0 000 turn the main breaker on the system to the OFF position 9 Turn the customer supplied assist gas supply OFF 10 Turn th...

Страница 44: ......

Страница 45: ...SIGMA LASER STENT AND TUBE CUTTER 990 401 A 1 Appendix A System Dimensions ...

Страница 46: ...SIGMA LASER STENT AND TUBE CUTTER A 2 990 401 ...

Страница 47: ... based on physical factors such as the fully dilated pupil size 7mm and beam hotspots 1mm For most all exposures to the skin and IR exposures to the eye lasting greater 10 seconds the involuntary movement of the eyes and the body as well as heat conduction will average an irradiance profile over an area of about 10 mm2 even if the irradiated body part is kept intentionally still This equates to a ...

Страница 48: ...as defined in Table I of 21 CFR Subchapter J Part 1040 10 Class I levels of laser radiation are not considered to be hazardous Class II laser product means any laser product that permits human access during operation to levels of visible laser radiation in excess of the accessible emission limits contained in Table II A of 21 CFR Subchapter J Part 1040 10 but does not permit human access during op...

Страница 49: ...he primary standard that outlines the safety of laser products Classification is based on calculations and determined by the AEL as with the ANSI standard but the IEC standard also incorporates viewing conditions Class 1 lasers are very low risk and safe under reasonably foreseeable use including the use of optical instruments for intrabeam viewing Class 1M lasers have wavelengths between 302 5 nm...

Страница 50: ...a point source however when measured with a 5 cm aperture all of the 10 mW would be collected and the measured power would exceed the AEL for Class 3R The product is to be classified as Class 1M as this is the smallest AEL which is not exceeded The irradiance is at least a factor of 3 below the MPE for 0 25 second exposure duration and is also below the MPE for an exposure duration longer than 10 ...

Страница 51: ...nown to cause skin or eye injury within the time period of the human eye aversion response 0 25 seconds Class 2MNot known to cause eye or skin damage within the aversion response time unless collecting optics are used N A N A Class 3a N A Lasers similar to Class 2 with the exception that collecting optics cannot be used to directly view the beam Visible Only Lasers similar to Class 2 with the exce...

Страница 52: ...ruments extended NOHA Same as Class 1 distinction with measurement requirements Class 2 Visible low power lasers Safe for unintended exposure prolonged staring should be avoided Blink reflex limits exposure duration to nominally 0 25 seconds MPE for 0 25 seconds not exceeded even with the use of optical instruments No hazard area when based on unintended exposure 0 25 seconds exposure duration 1 m...

Страница 53: ... divergent beams such as from fibers or LEDs i e eye loupes and magnifiers Generally only one of the group of optical instrument for a given laser product leads to an increase in the hazard Therefore at the discretion of the manufacturer a specific wording can be added to the warning label See sections on optical instruments and warning labels below Chart Courtesy of David Sliney Note The above ta...

Страница 54: ...ous for exposure with optical instruments of either category 1 or 2 Measurement Conditions measured power AEL Condition 1 Condition 2 To account for possible use of Binoculars telescopes Eye loupes magnifiers Unaided eye Usually limiting condition for Large diameter well collimated beams Divergent beams Aperture diameter 50 mm 7 mm 7 mm Distance 2 m 14 mm 10 cm b simplified presentation strictly o...

Страница 55: ...chheim Germany TEL 49 89 839403 0 FAX 49 89 839403 10 AMADA MIYACHI TAIWAN CO LTD Rm 5 2F No 9 Dehui St Zhongshan Dist Taipei 10461 Taiwan R O C TEL 886 2 2585 0161 FAX 886 2 2585 0162 AMADA MIYACHI VIETNAM CO LTD M floor 400 Nguyen Thi Thap Street Tan Quy Ward District 7 Ho Chi Minh City Vietnam TEL 84 8 3771 7972 FAX 84 8 3771 7974 AMADA MIYACHI THAILAND CO LTD 40 14 Bangna Tower C 17th Floor Un...

Страница 56: ...AMADA MIYACHI AMERICA INC 1820 South Myrtle Ave Monrovia CA 91016 U S A TEL 1 626 303 5676 FAX 1 626 358 8048 ...

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