Covidien Articulating Absorba Tack Foil Pouch Leak Tester Owner s Manual IPE SN Rev 1
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1 Covidien Articulating Absorba Tack Foil Pouch Leak Tester Owner s Manual IPE SN Rev 1 MANUFACTURER: INNOVATIVE PRODUCTS & EQUIPMENT, INC. 5 PROGRESS AVE TYNGSBORO, MASSACHUSETTS U.S.A Revision 1
2 Table of Contents 1 REFERENCE DOCUMENTS DESCRIPTION OF SAFETY LABELS USED ON SYSTEM WARNING SIGNS MANDATORY ACTION SIGNS PROHIBITION SIGNS OTHERS DESCRIPTIONS OF SAFETY TERMS USED IN MANUAL ABBREVIATIONS AND ACRONYMS USED IN MANUAL DESCRIPTION OF THE SYSTEM PARTS, FUNCTIONS AND OPERATION OF THE FOIL POUCH LEAK TESTER SYSTEM PART LOAD & TEST GENERAL OPERATING PROCEDURE OPERATOR INTERFACE OPERATOR INTERFACE PANEL PUSH BUTTONS OPERATOR INTERFACE PANEL GENERAL, HMI SPLASH SCREEN MAIN SCREEN ACTIVE ALARM SCREEN ALARM HISTORY SCREEN SCREEN NAVIGATION MAINTENANCE SCREEN STATISTICS COMMUNICATIONS PART SETUP RECIPE EDIT INPUTS USON HMI SETUP PLC SYSTEM MONITOR START-UP SEQUENCE OPERATIONAL SEQUENCE FAULT RECOVERY AS BUILT MACHINE SETTING SYSTEM CALIBRATION DATA COLLECTION EXPORT DATA TO USB APPENDICES APPENDIX A REVISION HISTORY...40 Revision 1 Page 2 of 41
3 DANGER! To avoid possible injury and to operate the equipment in a safe and efficient manner, please observe the following safety measures: NEVER operate the equipment with the guarding removed (if applicable). NEVER disable or bypass safety or guard interlock switches (if applicable). Severe injury or death could occur. DO NOT operate this equipment with the electrical enclosure doors open. Only a qualified electrical technician should open the electrical enclosure(s). If it becomes necessary to open the doors, first disconnect all electrical power and pressurized air supplies and lockout per OSHA lock out / tag out procedures, or equivalent. DO NOT operate this equipment unless properly grounded. NEVER enter the guarded areas (if applicable) of the machine while the system is running. Any unauthorized modifications to the control circuitry or other parts of the system could RESULT IN INJURY to personnel OR DAMAGE to the equipment. FOLLOW all warning labels affixed to the equipment. DO NOT remove affixed warning labels. If any labels are destroyed or removed, notify Innovative Products & Equipment, Inc. for replacement. REVIEW and FOLLOW the safety instructions for all included components. DO NOT operate any system components before they are properly installed or set up by an authorized representative of Innovative Products & Equipment, Inc. NEVER use the equipment for a task other than the application for which it was designed. UNAUTHORIZED MODIFICATIONS to the equipment will VOID the warranty. ALWAYS replace blown fuses with fuses of the same type and rating. Revision 1 Page 3 of 41
4 1 REFERENCE DOCUMENTS Allen Bradley PLC and HMI Manuals Festo Pneumatic Actuators and Valves 2 DESCRIPTION OF SAFETY LABELS USED ON SYSTEM 2.1 WARNING SIGNS Identifies hazard Electrical Shock Electrocution Pinch Point Revision 1 Page 4 of 41
5 2.2 MANDATORY ACTION SIGNS Convey an action step that should be taken to avoid the hazard Lockout Electrical Power Maintain Safe Pressure Forklift Point (left) Forklift Point (right) Revision 1 Page 5 of 41
6 2.3 PROHIBITION SIGNS Used to convey a prohibited action Do Not Operate With Guard Removed Do Not Lift With Hook 2.4 OTHERS Protective Earth (ground) Protective Earth (ground) Revision 1 Page 6 of 41
7 3 DESCRIPTIONS OF SAFETY TERMS USED IN MANUAL DANGER hazardous situation which has a high probability of death or severe injury. Notice A statement of company policy as the message relates directly or indirectly to the safety of personnel or protection of property. 4 ABBREVIATIONS AND ACRONYMS USED IN MANUAL HMI Human / Machine Interface. Located on main operator panel, this interface screen allows for selection of product codes as well as fault / error messages. OSHA Occupational Safety and Health Act of US based industrial safety organization. PE Protective earth, ground. Revision 1 Page 7 of 41
8 5 DESCRIPTION OF THE SYSTEM 5.1 PARTS, FUNCTIONS AND OPERATION OF THE FOIL POUCH LEAK TESTER SYSTEM The machine s upper frame is comprised of aluminum extrusion members with clear polycarbonate barrier panels sitting on top of an aluminum plate having an electroless nickel finish. This entire upper frame is mounted onto a welded construction frame, which has four casters to allow the machine to be moved to a selected location. Two Uson Optima Leak Testers are mounted to the right side of the machine. The upper Uson controls Station #1. The lower Uson controls Station #2 and #3. An HMI (operator interface) is mounted to the left of the systems frame and includes a single screen, Estop, and Reset buttons. Revision 1 Page 8 of 41
9 . Electrical Enclosure An electrical enclosure, that includes a PLC (Programmable Logic Control), is mounted directly to left side of the frame. Pneumatic Assy Uson Cabinets (2) Uson panels that have the TCU controllers and pneumatic components are mounted to the back of the frame. Station 1 is in the right enclosure, Station 2 and 3 are in the left enclosure. Various pneumatic components (including valve bank) are mounted onto the right side of the frame of the machine on a common vertical aluminum plate with a lexan cover panel. Revision 1 Page 9 of 41
10 Sta #1 Sta #2 Sta #3 Optical Touch Button The operator will load a pouch onto the nest placing it within the dowel pin guides. The operator should place the pouch in the center area of the nest. The operator will repeat the load sequence in the remaining test stations. The operator will then press the optical touch button causing the door cylinder to extend downward and the front door to close. Revision 1 Page 10 of 41
11 Safety Switch Door Closed Sensing Edge Detector The front door has a sensor located on the bottom of the panel frame. This sensing edge length will detect obstructions during the front door closing sequence. If the sensing edge does detect an obstruction, the door will retract to the up position. A safety switch will detect once the front door is fully closed thereby initiating the lowering of the top vacuum chambers cover.. Revision 1 Page 11 of 41
12 Top Pressure Pad Pouch Force Decay Test Once the top vacuum chamber has reached the bottom vacuum chamber, a compressed o-ring running around the perimeter of the chamber seals the internal space the product and nest reside in. The nest mounts on top of a beam type load cell, itself mounted within the lower vacuum chamber. A vacuum is then created within the enclosed chamber causing the pouch to expand since it is filled with atmospheric pressure. This pouch expansion increases the force on the load cell. The force in monitored while the vacuum is applied. The vacuum will shut off once a set force has been reached. The Uson Optima tester then monitors the load cell force to determine if the pouch has a leak or not. A properly sealed pouch will maintain a force level against the load cell, whereas a leaking pouch will measure as a decaying force at the load cell. If an acceptable pouch is detected, the vacuum is removed, the top vacuum chamber is then raised to its home position and then the front door is raised allowing the operator to remove the accepted pouch Revision 1 Page 12 of 41
13 Pick & Place Arm w/vacuum EZ Light Display Locked Door Reject Bin Area When a pouch is determined to be a reject, the front door stays down after the top vacuum chamber is raised to its home position, thereby preventing the operator from accessing the reject. Instead, a pick and place arm using suction cups removes the reject pouch from the nest and drops it into a chute landing inside the reject bin area. An optical sensor verifies the pouch has passed into the chute. The reject bin sits within a locked cage located below. A red illumination at the EZ light is displayed along with a message at the HMI stating the supervisor must acknowledge the reject part. Once the supervisor has reset the fault button switch, the front guard door will raise allowing the operator to continue testing the next sample. All Stations Test & Reject Parts Condition If this multiple failed result occurs on all stations. The system requires the supervisor to follow the above procedure before the last station tested will properly handle & reject the pouch. The machine will not allow the safety door to open until this is done. Revision 1 Page 13 of 41
14 Locked Door Reject Bin Area Reject Bin Pouch Area If the supervisor wants to retrieve the rejected pouch or pouches sitting in the reject bin from the locked door, they will have to select the Reject Unlocked soft button on the HMI touch screen. The reject door will remain unlocked for 10 seconds. If the reject door is not opened within the 10 seconds, the door will lock again. Once the reject door closes, it will automatically lock. This will allow the access door to unlock. The supervisor may retrieve the rejected part from the reject bin area. It will thereby be the supervisor s responsibility for the product count. Revision 1 Page 14 of 41
15 5.2 PART LOAD & TEST RFID Scanner USON Optima VT Screen Station #1 USON Optima VT Screen Station #2 & #3 HMI Touch Screen Solenoid Lock on reject cage Optical Touch Button Once the code (barcode) is received from the upstream process and all parts has been manually placed in the test chambers. Press the optical touch button until the front pneumatic door is fully closed. After the chamber closes the Uson Optima VT will control the leak test sequence which will consist of a Force Decay method. The system uses an indirect measurement technique to determine the integrity of the pouch. The leak test cycle time is estimated to be Seconds. At the end of the Leak Test the Optima VT will provide an Accept or Reject signal based on the test results. If any part fails the Leak test the Pouch will be automatically removed and offloaded to a reject chute into a locked reject bin. The system will incorporate photoelectric switches to verify that the rejected pouch is loaded into the reject bin. If the part passes the leak test an accept signal will be sent to a Covidien provided printer to print a label. The chamber and guard door will open and the operator will remove the Pouch. Revision 1 Page 15 of 41
16 5.3 GENERAL OPERATING PROCEDURE The following is a general guide to operating the machine. When the machine is powered on, perform the following: 1. If the E-stop is pressed, pull the E-Stop button and press the reset button on the HMI. The white reset button will illuminate once the machine has reset itself. If not already in their raised position, the top vacuum chamber will raise to its home position and then the front door will raise. 2. Using the HMI, select the re-order code. 3. Load the product into the nest at the chosen station. 4. Press the optical touch button to lower the front guard door. Once the front door is completely shut, the operator may remove their hand from the optic button. 5. Once started, the EZ light will illuminate yellow and flash during the test cycle. 6. When the leak test is completed by the Uson, the EZ light will illuminate green if passed, or change to red if the sample failed. If red, the HMI will request to acknowledge reject. 7. If the sample passed, the EZ light will remain green and the front door will open. 8. The operator will remove the accepted pouch from all nests, and at the next station retrieve the printed patient label and apply it manually to the pouch. Revision 1 Page 16 of 41
17 6 OPERATOR INTERFACE HMI Reset Button Emergency Stop 6.1 OPERATOR INTERFACE PANEL Allen-Bradley Panel View Plus Compact PUSH BUTTONS OPERATOR INTERFACE PANEL This system has a main operator interface with the following push buttons: Reset, illuminated & guarded white button E-Stop red push pull button Revision 1 Page 17 of 41
18 6.2 GENERAL, HMI The HMI is a device to enter information and inform the operators when there is an alarm; it has a touch screen and pushbuttons for the operator to input information to the machine. The display screen displays informational messages and alarms SPLASH SCREEN The Splash screen is displayed on power up. Touch anywhere to continue. Revision 1 Page 18 of 41
19 6.2.2 MAIN SCREEN Current reorder code selected 2. Total Parts run since last reset 3. Total passed parts since last reset 4. Total failed parts since last reset 5. Machine Status 6. Login Button 7. Station Enable/Disable Button Machine Status Displays - ESTOP Estop is pressed - Door Open Door is open - Faulted Fault Is Present - Ready Machine ready for operation - Running Machine currently testing a part - Cycle Stop Machine cycle stop requested - Initializing Machine is initializing (estop/door recovery) - Acknowledge Reject Acknowledge reject before continuing - Waiting for Barcode Cycle will not start until the upstream process sends a barcode - Revision 1 Page 19 of 41
20 6.2.3 ACTIVE ALARM SCREEN The Active Alarms screen displays the alarm message number with the date and time of the occurrence Displays active and acknowledged system alarms. Displays the time and date of when the alarm occurred ALARM HISTORY SCREEN The Alarm History screen displays any previous alarms that occurred with the date and time of the occurrence Displays previous alarms and acknowledged system alarms. Displays the time and date of when the alarm occurred. 2. Buttons to scroll through alarm history list. Revision 1 Page 20 of 41
21 6.2.5 SCREEN NAVIGATION The Screen Navigation Screen allows access to all the other screens on the HMI. Revision 1 Page 21 of 41
22 6.2.6 MAINTENANCE SCREEN The Station Status Screen displays the current state number of each station. Step number < 100, station is initializing Step number = 100, station is initialized and ready to run Step number > 100, station is running - Auto mode o In Auto mode, the machine will run through a complete test automatically o In Jog mode, the machine can be stepped through the motion by using the operator start buttons. Each time the operator start buttons are pressed, the machine will go to the next step. - Doors Locked o Status of the doors, to toggle the lock press on the button o The unlocked status is orange. NOTE: The machine will not operate with the doors unlocked. - Self Test o When enabled, the machine will run an empty cycle without a need for a code being sent from the upstream process. o This checks the integrity of the system. - Reject Unlocked o Used to unlock the reject door - Barcode Enabled o Allows the machine to run without a barcode present. NOTE: the system will not send barcode data to downstream printers if it is not enabled - Station Enabled o Allows station to be enabled or disabled as needed Revision 1 Page 22 of 41
23 Revision 1 Page 23 of 41
24 6.2.7 STATISTICS Displays current production data. Data can be reset by pressing the Reset Stats button on the screen COMMUNICATIONS Displays communication received from the upstream process and communications sent to the downstream process. Revision 1 Page 24 of 41
25 6.2.9 PART SETUP To select the correct reorder code, use the up/down arrows, then press the enter key. The reorder code highlighted is the selected code RECIPE EDIT This screen is used to type in the reorder code name and matching Uson test. As well as select the corresponding Program Number used by the Uson Leak Tester. Revision 1 Page 25 of 41
26 INPUTS The inputs screen displays the status of the input and output peripherals USON The Uson screen displays status of the Uson Input and Output peripherals. Revision 1 Page 26 of 41
27 HMI SETUP The Networking info/config screen display the machine s IP address as well as allows to exit from HMI to go into system configuration. System configuration is only available when logged in with engineering credentials. It is used to get to the operating system of the HMI PLC SYSTEM MONITOR The PLC System Monitor is used to display PLC diagnostics. Revision 1 Page 27 of 41
28 7 START-UP SEQUENCE 1) Reset Emergency Stop Button and close all the doors. 2) Press the Reset button on the Operator Interface Panel (white button). The Reset button should illuminate white. If not, verify step 1 was completed 3) Clear all faults listed on HMI by pressing the Reset Fault soft button on the HMI. 4) Press and hold the operator optical touch button and hold until door starts moving. 5) Once door is closed, the machine will initialize (return tooling to home position) 6) Door will open once all tooling is at home. 8 OPERATIONAL SEQUENCE 1) The system only starts if the following conditions are met: a. E-Stop is reset b. Main air is on c. The are no alarms active 2) Ensure the correct part type is selected 3) Place part in the station chambers. Ensure the part is within the locating pins 4) Press and hold the operator optical touch button and hold until door starts moving. 5) The station chambers will close and the Uson leak testers will start testing 6) If the part in all chambers passed, the chambers will open If the Parts in (2) stations passed and (1) station failed, the pouch will be automatically placed in the reject bin. If the Parts in (1) station passes and (2) station failed, the pouches will be automatically placed in the reject bin. 7) The front door will open. 8) The rejects will have to be acknowledged on the HMI screen Revision 1 Page 28 of 41
29 9 FAULT RECOVERY Faults are specific to the system operations. This condition will require an operator to: 1) Identify the fault from the description in the HMI. 2) Correct the alarm condition. 3) Acknowledge the fault by pressing the Acknowledge button located on the Operator Interface panel. ALARM Cause Solution Estop Detected (IN_600) Estop is pressed or power loss Check estops are pulled Main Air Should Not Be Air pressure is detected when air is not on Check air pressure sensor and/or On (IN_603) check air dump valve is not overridden Main Air Should Be On (IN_603) Air pressure is too low Check main air connection and pressure Door Should Be Closed Check sensors and/or possible Door did not close (IN_607/IN_608) mechanical interference Door Should Be Open Check sensors and/or possible Door did not open (IN_607/IN_608) mechanical interference Front Door Strip Activated Interference Detected Check door is clear. (IN_613) Station 1 Vacuum Chamber 1 Should Be Closed (IN_708/IN_709) Station 1 Vacuum Chamber 1 Should Be Opened (IN_708/IN_709) Station 1 Reject Pick and Place Horizontal 1 Should Be at Nest (IN_710/IN_711) Station 1 Reject Pick and Place Horizontal 1 Should Be at Chute (IN_710/IN_711) Station 1 Reject Pick and Place Vertical 1 Should be Lowered (IN_712/IN_713) Station 1 Reject Pick and Place Vertical 1 Should be Raised (IN_712/IN_713) Station 1 Reject Pick and Place Vacuum 1 Should Be On (IN_610) Station 1 Uson Did Not Start (IN_700) Chamber did not close Chamber did not open Reject Pick and Place did not complete move to nest Reject Pick and Place did not complete move to chute Reject Pick and place did not lower Reject Pick and Place did not raise Vacuum was not detected Uson did not start testing Check sensors and/or possible mechanical interference Check sensors and/or possible mechanical interference Check sensors and/or possible mechanical interference Check sensors and/or possible mechanical interference Check sensors and/or possible mechanical interference Check sensors and/or possible mechanical interference Check sensor and/or vacuum cups. This fault will occur if a part is not present Check uson unit Revision 1 Page 29 of 41
30 Station 1 Uson Pass/Fail Signals did not reset (IN_701/IN_702) Station 1 Uson did not return Pass/Fail Signal (IN_701/IN_702) Station 1 Part Did Not Enter Reject Bin 1 (IN_714) Station 1 Reject Bin Full or Part Jam in Reject Bin 1 (IN_714) Station 1 Part Failed, Acknwlegde Reject Station 2 Vacuum Chamber Should Be Closed (IN_800/IN_801) Station 2 Vacuum Chamber Should Be Opened (IN_800/IN_801) Station 2 Reject Pick and Place Horizontal Should Be at Nest (IN_802/IN_803) Station 2 Reject Pick and Place Horizontal Should Be at Chute (IN_802/IN_803) Station 2 Reject Pick and Place Vertical Should be Lowered (IN_804/IN_805) Station 2 Reject Pick and Place Vertical Should be Raised (IN_804/IN_805) Station 2 Reject Pick and Place Vacuum 2 Should Be On (IN_611) Station 2 Uson Did Not Start (IN_703) Station 2 Uson Pass/Fail Signals did not reset (IN_704/IN_705) Station 2 Uson did not return Pass/Fail Signal (IN_704/IN_705) Station 2 Part Did Not Enter Reject 2 Bin (IN_806) Station 2 Reject Bin Full or Part Jam in Reject 2 Bin (IN_806) Uson signals did not clear. Uson did not return a test result Part transfer failed Bin is full or part did not fall through chute Part Failed Chamber did not close Chamber did not open Reject Pick and Place did not complete move to nest Reject Pick and Place did not complete move to chute Reject Pick and place did not lower Reject Pick and Place did not raise Vacuum was not detected Uson did not start testing Uson signals did not clear. Uson did not return a test result Part transfer failed Bin is full or part did not fall through chute Check uson unit Check uson unit Check Pick and Place Check sensors and/or possible part jam. Acknowledge fault to continue Check sensors and/or possible mechanical interference Check sensors and/or possible mechanical interference Check sensors and/or possible mechanical interference Check sensors and/or possible mechanical interference Check sensors and/or possible mechanical interference Check sensors and/or possible mechanical interference Check sensor and/or vacuum cups. This fault will occur if a part is not present Check uson unit Check uson unit Check uson unit Check Pick and Place Check sensors and/or possible part jam. Revision 1 Page 30 of 41
31 Station 2 Part Failed, Acknwlegde Reject Station 3 Vacuum Chamber Should Be Closed (IN_808/IN_809) Station 3 Vacuum Chamber Should Be Opened (IN_808/IN_809) Station 3 Reject Pick and Place Horizontal Should Be at Nest (IN_810/IN_811) Station 3 Reject Pick and Place Horizontal Should Be at Chute (IN_810/IN_811) Station 3 Reject Pick and Place Vertical Should be Lowered (IN_812/IN_813) Station 3 Reject Pick and Place Vertical Should be Raised (IN_812/IN_813) Station 3 Reject Pick and Place Vacuum 3 Should Be On (IN_612) Station 3 Uson Did Not Start (IN_706) Station 3 Uson Pass/Fail Signals did not reset (IN_707/IN_614) Station 3 Uson did not return Pass/Fail Signal (IN_707/IN_614) Station 3 Part Did Not Enter Reject Bin 3 (IN_814) Station 3 Reject Bin Full or Part Jam in Reject Bin (IN_814) Station 3 Part Failed, Acknwlegde Reject Part Failed Chamber did not close Chamber did not open Reject Pick and Place did not complete move to nest Reject Pick and Place did not complete move to chute Reject Pick and place did not lower Reject Pick and Place did not raise Vacuum was not detected Uson did not start testing Uson signals did not clear. Uson did not return a test result Part transfer failed Bin is full or part did not fall through chute Part Failed Acknowledge fault to continue Check sensors and/or possible mechanical interference Check sensors and/or possible mechanical interference Check sensors and/or possible mechanical interference Check sensors and/or possible mechanical interference Check sensors and/or possible mechanical interference Check sensors and/or possible mechanical interference Check sensor and/or vacuum cups. This fault will occur if a part is not present Check uson unit Check uson unit Check uson unit Check Pick and Place Check sensors and/or possible part jam. Acknowledge fault to continue Revision 1 Page 31 of 41
32 10 AS BUILT MACHINE SETTING Main Air Main Air Regulator 75psi Main Air Pressure Switch Min Pressure 60psi Minimum air feed ID: 1/2inch HMI SECURITY HMI Username Password ENGR eng Super User super Or use RFID card to log on USON Supervisor Access Password 7942 Administrator Access Password Revision 1 Page 32 of 41
33 11 SYSTEM CALIBRATION The Load cell and the vacuum sensors can be calibrated using the built in calibration sequence in the Uson System. Here are the steps required to calibrate the system: 1 Exit Run Mode and press Test Setup 2 Select the test for the specific device to be calibrated. The tests are located at the 100 range Revision 1 Page 33 of 41
34 3 On the main menu select options 4 Select the tester control tab. 5 - Change Program Selection and Start option to front panel Revision 1 Page 34 of 41
35 6 On the main menu, select hardware setup 7 Select the Sensors tab then select the sensor to calibrate 8- Select the start button to start the calibration Revision 1 Page 35 of 41
36 9 Step 1 is to calibrate using the value listed under Cal Pt kg. In this case, it requires a 0kg setpoint. Press accept once the 0kg setup is achieved. Repeat for Step 2 where a weight must be placed on the load cell before pressing accept. 10 Once both points have been completed, press the done button to accept changes Revision 1 Page 36 of 41
37 11 On Main menu and press Test Setup 12 Select a production test (1 though 6) Revision 1 Page 37 of 41
38 13 On the main menu select options 14 Select the tester control tab. Then change Program Selection Source and Start Option back to TCU 12 DATA COLLECTION 1 On Main menu, select options Revision 1 Page 38 of 41
39 2 Select the Logging tab Revision 1 Page 39 of 41
40 3 Select the Services Tab on main menu 13 EXPORT DATA TO USB 1 Select the Export Tab. - Insert usb stick - Press on Select USB Disk then select the USB drive - On the data to export pull down menu, select Audit Stats/Audit Logs Backup - Press export (a message on the blue banner will display export successful) - Press Safetly Remove before removing USB drive 14 APPENDICES 14.1 APPENDIX A REVISION HISTORY REV DATE BY DETAILS _01_16 RDB First Pass _01_16 RDB Release Revision 1 Page 40 of 41
41 2 3 Revision 1 Page 41 of 41
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