Glove Integrity tester specification - Dynamic Design … SN 001 Functional... · GIT-LCA Glove...

Dynamic Design Pharma, Inc. Page 1

Date: June 12, 2007

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GIT-LCA Glove Integrity TesterFunctional and Design Specification

S/N 001

1. SYSTEM DESCRIPTION 2

2. PRINCIPLE OF OPERATION 3

3. POSITIVE AND NEGATIVE PRESSURE MODE OF OPERATION 3

4. SYSTEM COMPONENTS 6

5. CONTROL SYSTEM REQUIREMENTS 8

6. CONTROL SYSTEM - GENERAL 8

7. PARAMETERS MANAGEMENT 13

8. LEAK TEST CYCLE 15

9. SYSTEM TEST FUNCTION 23

10. IN–SITU CALIBRATION 24

11. INPUT/OUTPUT DETAILS 25

12. COMMUNICATIONS 27

13. PRINTING FUNCTION 28

14. OIT SPECIFICATION 30

15. APPENDIX A 36

16. APPENDIX B 41

GIT-LCA Glove Integrity Tester Page 2

Functional and Design Specification Date: June 12, 2007


1. System DescriptionThe system performs the function of in situ hole/slit detection in the glove and/or sleeve of a barrierisolator system. The system consists of a control module and the gloveport interface hardware.

The control module is a moveable console that features an operator interface control panel, pneumatic andelectronic components and process instruments.

The glove interface hardware consists of a gloveport cover that seals off the glove and/or sleeve so thatthe leak test process can take place. The gloveport cover is connected to the console via an umbilicalcord.

GLOVE WHILE IN USE

GLOVEUNDER

TEST

BARRIER ISOLATOR SYSTEMVACUUM

CHAMBER

PNEUMATICCONNECTION

CONTROLCONSOLE

OPERATOR

NON-STERILE FILLINGROOM

STERILE ENVIRONMENT

Figure 1. Basic system components, while in use (Negative Pressure Testing)




GAUNTLETUNDER TEST

GIT-LCAGLOVEINTEGRITYTESTER

BARRIER ISOLATOR

Figure 2. Basic system components, while in use (Positive Pressure Testing)

2. Principle of operationThe system concept consists of detecting airflow escaping through slit/holes in the glove/sleeve. To detectsuch airflow, the glove/sleeve assembly is inflated using a predetermined airflow rate.

Such airflow rate causes the inflated glove/sleeve to reach a pressure equilibrium that is dictated by theamount of air leaking out. This internal pressure level is measured and compared to a threshold value.

If the pressure value is higher than the preset value, the glove/sleeve is considered good.

If the value falls below the preset value, the glove/sleeve is considered to be faulty.

3. Positive and Negative Pressure mode of operation

3.1. Description

3.1.1. The system permits applying a pressure to the glove under test by either applying apositive pressure from the outside of the isolator or by applying a negative pressurealso from the outside of the isolator.

Note: the application of negative pressure to the test glove from the outside of theisolator is the same as applying positive pressure to the surfaces of the test glove fromwithin the isolator volume.

3.2. Switching from mode to mode




3.2.1. The compressed air source has both a positive pressure output port and a negativepressure suction port. A single source compressor is used to achieve both positive andnegative pressure functions.

3.2.2. The same instruments are used to measure the relevant pressure and flow rate duringboth positive and negative mode of operation. For the instrumentation to functionproperly, the polarity of the pneumatic connection is respected. Five valves areadopted to switch from the positive to the negative mode of operation.

3.2.3. A selector control on the OIT performs the function of switching between the twomodes of operation.

3.3. Gloveport interface hardware differences

3.3.1. The gloveport interface hardware is dedicated to the type of test to be performed.

3.3.2. In the case of positive pressure testing, the application of a sealing cover to thegloveport suffices to pressurize the glove. If only the glove is to be tested, the sealingcover is applied to the cuff.

3.3.3. In the case of negative pressure testing, the glove under test is enclosed inside avacuum chamber located outside of the isolator system.

3.4. Flow diagram, functional description

3.4.1. Figure 3 shows a schematic P&ID of the system. The positive and negative mode ofoperation is achieved within the same control module by means of a number ofsolenoid valves.




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Figure 3. – Positive/Negative pressure flow diagram




3.5. Major system component

3.5.1. Compressor: Reciprocating piston compressor.

3.5.2. Pressure inlet valve, pressure regulator and pressure gage: Regulate the output of thecompressor to the desired pressure level.

3.5.3. Vacuum inlet valve, vacuum regulator and vacuum gage: Regulate the output of thecompressor to the desired vacuum level.

3.5.4. Vacuum/Pressure select valve: Routes either the vacuum line or the pressure line tothe control console pneumatic control system.

3.5.5. Inflate valve: Provides high flow pressurization action of the test item.

3.5.6. Deflate valve: provides high flow internal pressure drop of the test item.

3.5.7. Flow direction valve: Selects the flow direction through the mass flow controllerdepending on the positive or negative mode of operation.

3.5.8. Mass flow controller: Instrument that sets the flow rate based on a set point voltagelevel.

3.5.9. Pressure polarity valve: Provides means of switching the connections of the pressuretransducer depending on the positive or negative mode of operation.

3.5.10. Pressure transducer: Instrument that measures the internal pressure of the test item.

3.5.11. Channel control valves: Valves that switch the flow and the pressure lines between theA and the B channel.

3.5.12. Calibration device: Assembly that is connected to the system during the in-situcalibration process. The assembly is connected to dedicated fittings located in the rearof the control console.

3.5.13. Control System: Programmable Logic Controller (PLC) and Operator InterfaceTerminal (OIT) that control the functions of the valves, obtain and interpret data fromflow and pressure instruments and control all active functions of the system.

4. System components

4.1. Gloveport interface hardware

4.1.1. The gloveport interface hardware may take a number of different configurations inthat it must interface with the user’s glove hardware. See System Specificationdocument for details.

4.2. Control console

The control console includes the following functions:

4.2.1. Electrical power components

4.2.1.1. Circuit protection devices.

4.2.1.2. 24VDC power supply.






4.2.1.5. Terminal Boards, AC circuit, DC circuit and Ground.

4.2.2. Programmable Logic Controller (PLC)

4.2.2.1. GE Micro PLC4.2.2.1.1. 13 digital inputs4.2.2.1.2. 10 digital outputs4.2.2.1.3. 2 Analog Inputs4.2.2.1.4. 1 Analog output.

4.2.2.2. Input power: 115VAC

4.2.3. Sensors and control devices

4.2.3.1. Pressure transducer, 0-3750 Pa range, 4-20 ma output.

4.2.3.2. Mass flow transducer and controller, 0-100 Sccm range, 0-5VDC output,0-5VDC control signal.

4.2.3.3. Inflate valve, automatic, solenoid controlled, 24VDC coil

4.2.3.4. Deflate valve, automatic, solenoid controlled, 24 VDC coil

4.2.3.5. Positive/Negative pressure mode switching valves, 5 required, solenoidcontrolled, 24VDC coil.4.2.3.5.1. Vacuum/pressure valve4.2.3.5.2. Flow direction valve4.2.3.5.3. Pressure polarity valve4.2.3.5.4. Pressure Inlet Valve4.2.3.5.5. Vacuum Outflow Valve

4.2.3.6. Channel control valves, solenoid controlled, 24VDC coils4.2.3.6.1. Flow control valve (A/B)4.2.3.6.2. Pressure control valve (A/B)

4.2.3.7. Beeper unit, 24VDC coil.

4.2.4. Compressed/Vacuum air management

4.2.4.1. Compressor, 1.0 SFCM, 30 psi

4.2.4.2. Coalescing filter, 3 micron porosity.

4.2.4.3. Pressure regulator, 0-6 psi range

4.2.4.4. Pressure gage, 0-15 psi range

4.2.4.5. Vacuum regulator

4.2.4.6. Vacuum gage, 0-30 inch-hg range.

4.2.4.7. Cooling fan

4.2.5. Operator control panel

4.2.5.1. Red Lion G306 model OIT. Size 5.7 inches active window, 5-buttonkeypad.




4.2.5.2. Printer, serial communication, P/N USMP-EPC1100-BLK USMicroproducts.

5. Control System Requirements

5.1. Single input power, 115VAC, 15 amps, 60Hz.

5.2. Optional: Single input power, 220VAC, 7.5 amps, 50Hz.

5.3. Control hardware: Programmable Logic Controller

6. Control System - General

6.1. Warm Up sequence upon power up

The machine requires a few minutes warm up time before it can be used. The time out processoccurs automatically.

6.1.1. The operator applies power to the system by actuating the Power On switch located inthe rear of the machine

6.1.2. Upon power up, the control system goes into a warm up mode, The following occurs:

6.1.2.1. The Pressure Inlet valve K6 and the Vacuum Outflow valve K7 areactuated.

6.1.2.2. The OIT displays the Warm Up screen

6.1.2.3. Part of the Warm Up screen is the display of the value of the count downtimer, indicating the time remaining in the Warm Up period.

6.1.2.4. The beeper is active – see beeper function specification.

6.1.3. The Warm Up time is hard coded in the PLC and cannot be changed.

6.1.4. When the Warm Up timer expires, the following occurs:

6.1.4.1. The OIT automatically switches to the Home screen.

6.1.4.2. The system goes into Standby mode – see Standby Mode specification.

6.2. Test Channels

6.2.1. The system has two separate leak test channels.

6.2.2. The channels are labeled A and B.

6.2.3. The channel selection is made via the OIT prior to the following activities:

6.2.3.1. Leak Test cycle.

6.2.3.2. System Test operation.

6.2.3.3. Parameter entry.

6.2.4. Channel selection cannot be changed while the Leak Test is in progress.

6.3. Component control

6.3.1. Inflate valve – K2

6.3.1.1. De-actuated during Warm Up




6.3.1.2. De-actuated in Standby

6.3.1.3. While the Leak Test cycle is active:6.3.1.3.1. Actuated during Inflate phase, until the pressure

stabilization value is reached.6.3.1.3.2. Pulsed during pressure stabilization phase, according to

Stabilization phase pulse control.6.3.1.3.3. De-actuated at any of the following conditions:

6.3.1.3.3.1. P(pv) > Pmax A-channel.

6.3.1.3.3.2. P(pv) > Pmax B-channel.

6.3.1.3.3.3. P(pv) > 3750Pa.

6.3.1.4. Actuated manually from OIT while in System Test mode when the HighFlow Plus button is depressed and P(pv) > 3750Pa..

6.3.1.5. De-actuated during calibration.

6.3.2. Deflate valve – K1

6.3.2.1. Actuated during Warm up.

6.3.2.2. Actuated in Standby.

6.3.2.3. While the Leak Test cycle is active:6.3.2.3.1. Actuated at the end of the pressure stabilization phase until

the P(pv) < P(thsld). This is the deflate phase of the Leaktest cycle.

6.3.2.3.2. Actuated at the following conditions:6.3.2.3.2.1. P(pv) > Pmax A-channel.

6.3.2.3.2.2. P(pv) > Pmax B-channel.

6.3.2.3.2.3. P(pv) > 3750Pa.

6.3.2.4. Actuated manually from OIT in System Test mode when the High FlowMinus button is pressed.

6.3.2.5. De-actuated during calibration.

6.3.3. Vacuum/Pressure valve – K3

6.3.3.1. Actuated when the system is programmed to operate in positive pressuremode during either Leak Test or System Test.

6.3.3.2. Actuated during calibration process.

6.3.4. Flow direction valve – K4



6.3.5. Pressure polarity valve – K5






6.3.6. Pressure inlet valve – K6

6.3.6.1. Actuated during warm up.


6.3.6.3. De-actuated when the system is programmed to operate in negativepressure mode during either Leak Test or System Test.



6.3.7. Vacuum outflow valve – K7

6.3.7.1. Actuated during warm up.

6.3.7.2. De-actuated when the system is programmed to operate in positivepressure mode during either Leak Test or System Test.

6.3.7.3. Actuated when the system is programmed to operate in negative pressuremode during either Leak Test or System Test.


6.3.7.5. De-actuated during calibration process.

6.3.8. Channel Select – Pressure – K8

6.3.8.1. Leak test mode: Actuated when “A” channel is active.

6.3.8.2. System Test mode: Actuated when “A” channel is active.

6.3.9. Channel Select – Flow – K9

6.3.9.1. Leak test mode: Actuated when “A” channel is active.

6.3.9.2. System Test mode: Actuated when “A” channel is active.

6.4. Security

Parameter and calibration values security is achieved by interlocking the access to those valuesusing a dedicated key lock switch.

6.4.1. The protected functions are:

6.4.1.1. Parameters management

6.4.1.2. In-situ calibration

6.4.2. Key lock in the “locked” mode disables access to the protected functions.

6.4.3. Key lock in the “unlocked” mode enables access to the protected functions.

6.4.4. Key lock is such that the key cannot be removed with the unit left in the “unlocked”mode.




6.4.5. The position (locked or unlocked) position of the key lock has no impact on Leak testand System test functions.

6.4.6. Key lock in the “locked” position

6.4.6.1. Attempted access to the parameter management function results in a“access denied” popup screen.

6.4.6.2. Attempted access to the in-situ calibration function results in a “accessdenied” popup screen.

6.4.7. Key lock in the “unlocked” position

6.4.7.1. Entry into the parameter function is allowed after a confirmation popupscreen.

6.4.7.2. Entry into the in-situ calibration function is allowed after a confirmationpopup screen.

6.5. Standby mode

6.5.1. The system is in Standby mode if the following condition are present:

6.5.1.1. Warm up sequence is not active

6.5.1.2. Leak Test is not active

6.5.1.3. System Test is not active

6.5.1.4. Calibration is not active

6.5.2. The Pressure Inlet valve is actuated

6.5.3. The Vacuum outflow valve is actuated

6.5.4. The Deflate valve is actuated

6.5.5. The Inflate valve is de-actuated

6.6. Beeper Control

A beeper is energized to provide audible system status information to the operator

6.6.1. The duration of the beeper pulse is fixed at 200ms.

6.6.2. The beeper beeps at 0.5 hz frequency (2 second intervals) during the warm up phase.

6.6.3. The beeper beeps at 5 hz frequency (0.2 second intervals) to indicate a failure toinflate the glove.

6.6.4. The beeper beeps at 5 hz. frequency (0.2 second intervals) when the flow rate driftsoutside the LL and UL limits during the Leak Test phase of the cycle.

6.6.5. The beeper beeps at varying intervals during the leak test phase of the cycle.

6.6.5.1. Segment 1 < 10sec remaining in T(lt) => beeper freq. = 2.0 hz.(0.5 second interval)






6.6.5.4. Segment 4 > 60sec remaining in T(lt) => beeper freq. = 0.2 hz.(5.0 second interval)

6.6.5.5. The beeper beeps continuously for 5 seconds once the leak test timerexpires.

6.6.6. Beeper control under Pressure Trending test conditions

6.6.6.1. The beeper beeps continuously for 5 seconds once the leak testconcludes.




7. Parameters ManagementThe system includes a number of process parameters. Parameters fall into pressure, airflow and timemanagement categories.

7.1. Parameters – General

7.1.1. Access to the Parameter Management screen is allowed only if the key interlock is setin the “access” position.

7.1.2. Parameter values are stored in the PLC.

7.1.3. Each channel (A/B) has its own set of parameters.

7.2. Parameter entry

7.2.1. The Main Parameter screen permits the following:

7.2.1.1. A or B channel selection

7.2.1.2. Selection of the Mode of operation, with associated confirmationscreens.

7.2.1.3. Turning on/off the Pressure Trending function, with associatedconfirmation screens.

7.2.1.4. Access to screens that manage Cycle Control parameters.

7.2.1.5. Access to screens that manage Pressure Trending parameters.

7.2.1.6. Print out of the current value of each parameter in the system.

7.2.2. Parameter value entry is allowed as follows:The following parameter entry process applied to both the Cycle parameters and thePressure Trending parameters.

7.2.2.1. A pop up keypad is accessed by touching any of the parameter numericvalue cell.

7.2.2.2. Each parameter value entry is compared to hard coded limits that defineits acceptability to the process.

7.2.2.3. If one or more of the parameter values are changed, a message appearsacross the bottom of the screen to instruct the operator of the condition.

7.2.3. Once the changes have been completed, a Save button allows storage of the newparameters into memory.

7.2.4. A confirmation entry is required of the operator before the parameter values arestored.

7.2.5. The ability of exiting the parameter management function without saving the enteredparameters is provided.

7.3. Process Parameters

7.3.1. The Leak Test Cycle programmable parameters, the units and hard coded limits are:

7.3.1.1. Maximum Pressure (pa) (Over-Pressure Level – 3750)




7.3.1.2. Over-Pressure level (pa) (Threshold Pressure – Maximum Pressure)

7.3.1.3. Threshold Pressure (pa) (0 – Over-Pressure Level)

7.3.1.4. Minimum Flow (Sccm) (0 – Maximum Flow)

7.3.1.5. Maximum Flow (Sccm) (Minimum Flow – 100)

7.3.1.6. Inflate Time (seconds) (0-300)

7.3.1.7. Stabilization time (seconds) (0-300)

7.3.1.8. Leak test time (seconds) (0-600)

7.3.2. The Pressure Trend programmable parameters and the hard coded limits are:

7.3.2.1. Time before sampling (seconds) (0 – Leak Test Time)

7.3.2.2. Time between pressure samples (seconds) (3-30)

7.3.2.3. Number of samples I trend (seconds) (0-100)




8. Leak test cycle

8.1. Leak Test Cycle – General

8.1.1. Leak Test Cycle start

8.1.1.1. The operator installs the gloveport interface hardware onto the device tobe tested.

8.1.1.2. Operator enters the Cycle Control screen from the Home screen.

8.1.1.3. Operator selects the desired channel (A or B)

8.1.1.4. Operator pressed the START button on the OIT to initiate the leak testcycle sequence.8.1.1.4.1. The OIT display indicates that the Leak Test is in progress

(Start => Stop and Red => Green).

8.1.2. Leak Test Cycle remains active until one the following conditions occurs:

8.1.2.1. Cycle Stop button on the OIT is pressed.

8.1.2.2. The Inflate timer times out (failure to inflate).

8.1.2.3. The Leak Test cycle concludes.

8.1.3. While the Leak Test cycle is active:

8.1.3.1. The active channel cannot be changed. Attempt to do so brings on amessage across the bottom of the screen: “You cannot change the activechannel while the leak test cycle is in progress”

8.1.3.2. A number of data displays provide an indication of the current status ofthe Leak Test Cycle while it is progressing through its phases.8.1.3.2.1. “Standby” when the Leak test cycle is not active.8.1.3.2.2. “Inflate” during the inflate phase.8.1.3.2.3. “Stabilize” during pressure stabilization phase.8.1.3.2.4. “Deflating” during deflating phase before leak test phase.8.1.3.2.5. “Leak Test” during the leak test phase.8.1.3.2.6. “Time Delay” before pressure trending start.8.1.3.2.7. “Pressure Trending” while the pressure trending algorithm

is active.

8.2. Leak Test Cycle phases definition

The glove integrity test cycle consists of the following phases.

8.2.1. Inflate Phase

8.2.2. Stabilization Phase

8.2.3. Deflate Phase

8.2.4. Leak Test Phase

8.2.4.1. Time duration based




8.2.4.2. Pressure trend based

Figure 4 provides a graphical representation of the leak test cycle.




0

PRES

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E (P

A) 3500

TIME

P (threshold)3000

2500

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PASS

FAIL

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Flow UL

Flow LL

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4000

P (over)P (clamp)

DEFLATE

Figure 4. Air flow and pressure profile during leak test




8.3. Inflate Phase

8.3.1. The Inflate Phase becomes active upon the start of the Leak Test Cycle. The itemunder test is automatically inflated to the programmed pressure value.

8.3.2. While the Inflate Phase is active

8.3.2.1. The T(inflate) timer counts, its value is displayed on the OIT.

8.3.2.2. The OIT displays the active phase (Inflate).

8.3.2.3. The Inflate valve actuates until the P(ovr) pressure level is reached.

8.3.3. Inflate failure

8.3.3.1. An inflate failure will occur if the item under test does not reach theprogrammed pressure value within the programmed time duration.

8.3.3.2. T(Inflate) times out8.3.3.2.1. Leak Test cycle becomes inactive (Standby mode)8.3.3.2.2. Pop-up window warns the operator that the test item has

failed to inflate.

8.3.4. Inflate success

8.3.4.1. Once the pressure reaches the programmed level, the systems advancesto the Pressure Stabilization phase of the cycle.

8.3.5. Re-start of the Leak Test cycle clears the fault condition.

8.4. Pressure Stabilization Phase

8.4.1. The Stabilization Phase becomes active upon successful conclusion of the InflatePhase => Pressure of test item is > P(ovr)

8.4.2. Stabilization Phase functionality

8.4.2.1. The T(stab) timer counts down to 0 (zero).

8.4.2.2. A P(clamp) value is calculated from the P(ovr) value. Fixed value, notprogrammable. P(clamp) = P(ovr) + 50

8.4.2.3. The pressure is pulsed, as follows:8.4.2.3.1. P(pv) = or > P(clamp) Inflate valve = OFF8.4.2.3.2. P(pv) < P(clamp) Inflate valve is ON.8.4.2.3.3. Sequence repeats for the duration of the phase.

8.4.3. While Stabilization is active

8.4.3.1. The pressure value is maintained above the P(ovr) programmed value fora programmed time duration.

8.4.3.2. The OIT displays the active phase.

8.4.3.3. The OIT displays the remaining phase time.

8.4.4. Once the T(stab) timer reaches 0 (zero), the system advanced to the Deflate Phase ofthe Leak Test cycle.




8.5. Deflate phase

8.5.1. While the Deflate Phase is active

8.5.1.1. The OIT displays the active phase.

8.5.2. When T(stab) expires, the following occurs:

8.5.2.1. Inflate valve turns off

8.5.2.2. The Deflate valve actuates and remains actuated until P(pv) = or <P(thrsld).

8.5.2.3. Leak Test phase starts when P(pv) = or < P(thrsld).

8.6. Leak Test phase

8.6.1. While the Leak Test Phase is active

8.6.1.1. OIT displays the active phase

8.6.1.2. OIT displays the time remaining in the phase.

8.6.1.3. Flow Rate value is monitored (see Interlock section)

8.6.2. Leak Test duration methodology

8.6.2.1. Time based when the Pressure Threshold method is active

8.6.2.2. Pressure value based when the Pressure Trending method is active.

8.6.3. Pressure Threshold Leak Test Phase

8.6.3.1. A timer starts to time out the Leak Test cycle.

8.6.3.2. The duration is set by T(lt) parameter.

8.6.3.3. Leak test outcome determination (Cycle Time out)8.6.3.3.1. When the T(LT) Leak Test Timer expires, the P(pv) value

is compared with the threshold value.8.6.3.3.2. If the P(pv) is greater than P(thrsld), the leak test outcome

is marked as “Pass”.8.6.3.3.3. If the P(pv) is smaller than P(thrsld), the leak test outcome

is marked as “Fail”.

8.6.4. Pressure Trending Leak Test Phase

8.6.4.1. When T(stab) expires and the pressure reaches the threshold value [P(pv) = P(thsld) ], a programmable time delay is started.

8.6.4.2. At the end of this time delay, the following pressure trending algorithmis activated.

8.6.4.3. A strobe pulse is activated. Strobe frequency is a programmableparameter.

8.6.4.4. Each strobe stores the P(pv) into a register.

8.6.4.5. Each data value is compared with the previous data value.




8.6.4.6. If the value is greater, meaning that the pressure is increasing, andP(pv) > P(threshold) the following occurs:8.6.4.6.1. Positive Trend counter is incremented.8.6.4.6.2. Negative Trend counter is reset.

Note: Positive Trend counter is reset if the pressure value drops by morethan 5 pascals between reading samples. This is an indication ofexcessive oscillation of the pressure level/value.

8.6.4.7. If the value is smaller, meaning that the pressure is decreasing, and theP(pv) < P(threshold) the following occurs:8.6.4.7.1. Negative Trend counter is incremented.8.6.4.7.2. Positive Trend counter is reset.

Note: Negative Trend counter is reset if the pressure value climbs bymore than 5 pascals between reading samples. This is an indication ofexcessive oscillation of the pressure level/value.

8.6.4.8. If the P(pv) value is unchanged, meaning that system is in equilibrium:8.6.4.8.1. If P(pv) > P(thrsld):

8.6.4.8.1.1. Positive trend counter is incremented.

8.6.4.8.1.2. Negative Trend counter is reset.

8.6.4.8.2. If P(pv) < P(thrsld):8.6.4.8.2.1. Negative trend counter is incremented.

8.6.4.8.2.2. Positive Trend counter is reset.

8.6.4.9. Trend determination8.6.4.9.1. When the Positive Trend counter reaches the value of

parameter “Number of data samples in a trend”, a positivetrend is determined.

8.6.4.9.2. When the Negative Trend counter reaches the value ofparameter “Number of data samples in a trend”, a negativetrend is determined.

8.6.4.10. When a Positive or Negative trend is determined, the Leak Test cycle isconcluded.

8.6.4.11. Leak test outcome determination (Pressure Trending)8.6.4.11.1. When a pressure trend is determined, the current pressure

value is compared with the programmed threshold value.8.6.4.11.2. If the P(pv) is greater than P(thrsld) and a positive trend

was determined, the leak test outcome is marked as “Pass”.8.6.4.11.3. If the P(pv) is less than P(thrsld) and a negative trend was

determined, the leak test outcome is marked as “Fail”.

8.7. Test cycle conclusion




Upon conclusion of the Leak Test phase, either with the Pressure Threshold method or thePressure Trending method, the following occurs.

8.7.1. The OIT automatically displays the Cycle Results screen.

8.7.2. The Cycle Results screen displays:

8.7.2.1. Pass/Fail visual display

8.7.2.2. Pressure and Flow rate values at the end of the test

8.7.2.3. Total cycle elapsed time.

8.7.2.4. An indicator displays whether the test concluded because of a leak testtime out or a pressure trend condition.

8.8. Interlock Conditions

8.8.1. Flow rate outside the programmed rangeThe leak test cycle will progress through the programmed leak test time as long as theflow rate remains within the programmed range.

8.8.1.1. If the flow rate drifts outside the programmed flow range, the followingwill take place:8.8.1.1.1. The leak test timer stops counting8.8.1.1.2. The beeper actuates to warn the operator of the condition.8.8.1.1.3. A message informs the operator of the condition and

remains active for 5 second time duration.8.8.1.1.4. If the out-of-range condition remains active for time

duration longer than 10 seconds (hard coded value), thecycle aborts and a popup screen comes on to warn theoperator of the condition.

8.9. Screen Navigation Related to Cycle Control

8.9.1. Cycle Control screen

8.9.1.1. Previous button – Enters the Print Cycle Results screen so that the testresults of the last successful test cycle can be reviewed and/or printed.

8.9.1.2. Home button – Returns to the Home screen and places the system inStandby mode.

8.9.1.3. The Previous and the Home buttons are disabled while the Leak Testcycle is active.

8.9.2. Cycle Results screen

8.9.2.1. Printer icon button – Enters the Cycle Result Printing screen.

8.9.2.2. New Test button – Returns to the Cycle Control screen to start a newcycle.

8.9.2.3. Home button – Returns to the Home screen and places the system inStandby mode.

8.9.3. Print Cycle Results screen




8.9.3.1. Glove identification8.9.3.1.1. The glove ID entry is done at the leak test cycle printing

screen.8.9.3.1.2. The glove ID value is reset to zero (0) upon power up.8.9.3.1.3. The value entered is saved upon depressing the “Print”

button (also starts the print cycle).8.9.3.1.4. If a Leak Test cycle is initiated, independently of its

outcome, the glove ID value is changed to zero (0) and anew entry of the ID value is allowed.

8.9.3.1.5. Once the ID value is stored (ie. The Print button isdepressed) the ID value cannot be changed until a newleak test cycle is initiated.

8.9.3.1.6. Upon entry into the test cycle print screen, the stored valueof the glove ID displayed.

8.9.3.1.7. Glove ID entry label reflects whether the entry of a newglove ID value is allowed

8.9.3.2. Print button – Initiates the printing routine. After printing concludes, theCycle Results screen comes up automatically.

8.9.3.3. Exit button – Returns to the Cycle Control screen without printing.




9. System Test FunctionThe system provides means for testing that it is indeed functioning correctly by measuring pressure andflow rate when the gloveport interface hardware or the calibration device is connected to the system.

9.1. System Test general

9.1.1. When the system is in the System Test mode, all timers, test conditions and alarms,are ignored.

9.1.2. System Test screen is accessed from the Home screen.

9.1.3. The internal pressure will increase until a condition of equilibrium is reached.

9.1.4. A print out of the System Test values including the end of test timer value is obtainedby depressing the printer icon.

9.1.5. The timer value is reset each time the System Test function is accessed from the Homescreen.

9.1.6. System Test screen cannot be accessed while a leak test cycle is in progress.

9.2. System Test - Control

9.2.1. All parameters are ignored

9.2.1.1. Timers

9.2.1.2. Flow rate

9.2.1.3. Pressure threshold.

9.2.1.4. P(max) interlock remains active. If P(max) is reached the deflate valveactuates.

9.2.2. The System Test screen has the following features:

9.2.2.1. Pressure PV display

9.2.2.2. Raw (uncorrected) Pressure PV display

9.2.2.3. Flow PV display

9.2.2.4. Elapsed time display and reset

9.2.2.5. High Flow control buttons

9.2.2.6. Low Flow control buttons

9.2.2.7. Channel select selector button

9.2.2.8. Mode of operation (Positive or Negative) selector button.

9.2.3. Printer Function

9.2.3.1. The values of the current Pressure and Flow rate are stored when theprinter icon is depressed.

9.2.3.2. OK button = Prints values and returns to HOME screen

9.2.3.3. Cancel button = Returns to System Test screen without printing.




10. In–Situ calibrationThe system provides means for in-situ calibration of the control console. The in-situ calibration does nottake the place periodic calibration of the critical instruments. See appropriate section.

10.1. Calibration procedure

10.1.1. The operator installs the calibration device onto the rear of the console and makes therequired connections.

10.1.1.1. The A and/or B channel interconnecting tubing is disconnected from thegloveport interface(s) and connected to the ports of the calibrationdevice.

10.1.2. Step #1 – Pressure transducer calibration at 0 Pa.

10.1.2.1. Operator opens the system to atmosphere (0 Pa pressure).

10.1.2.2. Operator presses the “Enter” button on the OIT.

10.1.2.3. Timer starts to allow system to settle. At time out, the current value ofthe pressure is entered into the algorithm to calculate the propercorrection factor.

10.1.3. Step #2 – Pressure transducer calibration at “high” pressure.

10.1.3.1. Operator connects the system to precision orifice (“high” pressure).

10.1.3.2. Operator adjusts the flow rate using the Up and Down arrow key untilthe current flow rate reads 50 Sccm.

10.1.3.3. Operator presses the “Enter” button on the OIT.

10.1.3.4. Timer starts to allow system to settle. At time out, the current value ofthe pressure is entered into the algorithm to calculate the propercorrection factor.

10.1.3.5. If the flow rate drifts outside +/-2 SCCM from setpoint, the calibrationsequence is aborted.

10.1.4. Step #3 – Calibration factors confirmation.10.1.4.1.1. The two calibration factors are displayed on the OIT.10.1.4.1.2. The calibration factors can be saved into the system or the

calibration routine can exited without saving them.

10.2. Calibration constants and factors

10.2.1. The pressure value expected with an orifice of given size is a constant that is hardcoded into the control system.

10.2.2. The system uses this value to calculate the appropriate “high” pressure calibrationfactor.

10.2.3. The known factors used to calibrate the High Pressure point are:150 um diameter hole, 50 Sccm = 2500Pa (expected value)

10.2.4. The control system calculates calibration factors for the pressure according to the twodata points entered during the procedure.




10.2.5. Printing of the calibration factors is provided.

10.2.6. The capability of resetting the calibration factors to zero (0) is provided.

10.3. In-Situ calibration details

10.3.1. While in calibration mode, the system is automatically set up to run in positivepressure mode.

10.3.2. Process data affected

10.3.2.1. Pressure (pv) is corrected according to the following algorithm

10.3.3. Parameters

10.3.3.1. P(theo_lo) – Theoretical pressure value – Low point (atmosphere)

10.3.3.2. P(theo_hi) – Theoretical pressure value – High point (hard coded)

10.3.3.3. P(fo) – Pressure fixed offset

10.3.3.4. P(io) – Pressure incremental offset

10.3.4. Algorithm

10.3.4.1. Input:10.3.4.1.1. P(pv-lo) – data from the transducer, modified for units

correction, at the low point pressure calibration10.3.4.1.2. P(pv-hi) – data from the transducer, modified for units

correction, at the high point pressure calibration

10.3.4.2. Output:10.3.4.2.1. P(corr) – Corrected value of P(pv)

10.3.4.3. Calculations10.3.4.3.1. P(fo) = P(theo_lo) – P(pv_lo)10.3.4.3.2. P(io) = [P(theo_hi)-P(pv-hi)-P(fo)]/[P(pv_hi) – P(pv-lo)]10.3.4.3.3. P(corr) = P(pv) + P(fo)+ [P(io) * [P(pv)-P(pv-lo)]]

11. Input/Output Details

11.1. Analog Output control

11.1.1. Function descriptionVoltage output to the mass flow controller that determines the flow rate setpoint.

11.1.1.1. Flow Rate range of instrument = 0-100 Sccm

11.1.1.2. Voltage range required by instrument: 0-5V

11.1.1.3. Voltage range available at output: 0-10V

11.1.1.4. Full count range: 0-32,000

11.1.1.5. Required count range: 0-16,000

11.1.1.6. Display resolution required = 1 Sccm




11.1.1.7. Resolution= 16,000 counts / 100 Sccm = 160 counts/Sccm

11.2. Analog Input Control #1

11.2.1. Function descriptionCurrent input from Mass Flow controller


11.2.1.2. Current output range from instrument: 0-5VDC

11.2.1.3. Full count range: 0-32,000

11.2.1.4. Required count range = 0-16,000

11.2.1.5. Resolution required = 1 Sccm

11.2.1.6. Resolution=16,000 counts / 100 Sccm = 160 counts/Sccm

11.3. Analog Input Control #2

11.3.1. Function descriptionCurrent input from Pressure Transducer


11.3.1.2. Current output range from instrument: 4-20ma

11.3.1.3. Full count range: 0-32,000

11.3.1.4. Resolution required = 1 Pa

11.3.1.5. Resolution = 32,000 counts / 3750 Sccm = 8.533 counts/Pa




11.4. Input/Output List

Number Type Identifier Description Ref. Desig.

1 Digital input %I 1 Key Lock input

1 Digital input %I 2–%I 13 Spare inputs

2 Digital output %Q1 Spare

3 Relay Out %Q2 Inflate Valve K1

4 Relay Out %Q3 Deflate valve K2

Vacuum/pressure valve K3

Flow direction valve K4

5 Relay Out %Q4

Pressure polarity valve K5

6 Relay Out %Q5 Spare

7 Relay Out %Q6 Beeper

8 Relay Out %Q7 Pressure Inlet Valve K6

10 Relay Out %Q8 Vacuum Outflow Valve K7

Channel Select – Pressure K811 Relay Out %Q9

Channel Select – Flow K9

12 %Q10 Spare

13 Analog input %AI018 Pressure transducer (4-20ma)

14 Analog input %AI019 Flow transducer (0-5VDC)

15 Analog output %AQ012 Transducer control (0-5VDC)

12. Communications

12.1. Printer function of OIT

12.1.1. Driver: Raw Serial Port

12.1.2. Drive Settings: On Update Print_program()

12.1.3. Baud rate: 19200

12.1.4. Data bits: Eight

12.1.5. Stop bits: One

12.1.6. Parity: None

12.1.7. Sharing port: No

12.2. OIT-PLC

12.2.1. RS485 Comms Port – SNP Master




12.2.2. Drive: GE SNP Master

12.2.3. Baud Rate: 19,200

12.2.4. Data Bits: 8

12.2.5. Stop Bits: One

12.2.6. Parity: Odd

12.2.7. Port Mode: 4 Wire RS485 or RS422

12.2.8. Port Sharing: No.

13. Printing Function

13.1. Printing

The system provides means for printing desired machine set up and test information on a 2-1/4inch wide thermal paper strip.

13.1.1. The following types of print-outs can be obtained:

13.1.1.1. Parameter set

13.1.1.2. Cycle results

13.1.1.3. System Test

13.1.1.4. Calibration data

13.1.2. The printing function is activated according to the following principles:

13.1.2.1. Parameters set: Upon demand

13.1.2.2. Cycle Results report at the end of each test cycle.

13.1.2.3. System Test report: Upon demand.

13.1.2.4. Calibration data report: Upon demand.

13.1.3. Printing principles

13.1.3.1. The general heading is printed each time a print-out is generated.

13.1.3.2. Description of printing control functions13.1.3.2.1. Program is continuously scanning for one of the following

four flags to be “on”. Data is then printed according to theactive flag.13.1.3.2.1.1. Param_Print_OK

13.1.3.2.1.2. Cal_print_OK

13.1.3.2.1.3. Cycle_Print_OK

13.1.3.2.1.4. ST_Print_OK

13.1.4. General heading printing – Printed all the time

13.1.4.1. System ID: GIT-LCA Tester

13.1.4.2. Date: Month, Day, Year




13.1.4.3. Company: DDP Inc.

13.1.5. Parameter Printing

A B

Max. Pressure (Pa) P_MAX_A P_MAX_B

Over-Pressure (Pa) P_OVR_A P_OVR_B

Threshold (Pa) P_THSLD_A P_THSLD_B

Flow UL (Sccm) F_UL_A F_UL_B

Flow LL (Sccm) F_LL_A F_LL_B

Inflate T (Sec) T_INF_A T_INF_B

Stabilize T (Sec) T_STAB_A T_STAB_B

Leak Test T (Sec) T_LT_A T_LT_B

Delay T (Sec) T_DLY_A T_DLY_B

Sample T (sec) T_SMPL_A T_SMPL_B

Data points (n) N_READ_PT_A N_READ_PT_B

13.1.6. Cycle outcome printing

Glove ID number GLOVE_ID

Test Outcome PASS_FAIL

Channel ACTIVE_CHANNEL

End Pressure (Pa) P_END

End Flow (Sccm) F_END

Cycle Time (sec) T_ELAPSED

Test method TST_METHOD

13.1.7. System Test printing

Channel ST_CHANNEL

End Pressure (Pa) P_ST

End Flow (Sccm) F_ST

ST Time (sec) ST_TIMER

13.1.8. Calibration printing

Pressure Fixed offset (pa) P(Fixed-offset)

Pressure Incremental offset (pa) P(Incr-offset)




Pressure Low saved value (pa) P(pv-lo)

Pressure High saved value (pa) P(pv-hi)

14. OIT specification

14.1. Hardware specification

14.1.1. Red Lion G306 model OIT. Size 5.7 inches active window, 5-button keypad.

14.2. Screens and popups

14.2.1. Warm up

14.2.1.1. Display that “Warm Up” is currently active.

14.2.1.2. Display of the time remaining to complete the warm up sequence

14.2.2. Home

14.2.2.1. Navigation buttons14.2.2.1.1. Cycle Control14.2.2.1.2. Parameters14.2.2.1.3. System Test14.2.2.1.4. Calibration14.2.2.1.5. Utilities

14.2.2.2. Current date display

14.2.3. Cycle control

14.2.3.1. Cycle Start/Stop button

14.2.3.2. Pressure PV

14.2.3.3. Flow PV

14.2.3.4. Pressure Trending ON/OFF indicator

14.2.3.5. Positive pressure trend counter status

14.2.3.6. Negative pressure trend counter status

14.2.3.7. Flow UP/DN arrows

14.2.3.8. Leak test cycle phase

14.2.3.9. Phase Time Remaining

14.2.3.10. Total Cycle Time Elapsed

14.2.3.11. Channel select

14.2.3.12. “Home” button

14.2.3.13. “Results” button

14.2.4. Inflate failure popup




14.2.4.1. Display text that describes possible cause

14.2.4.2. Exit button

14.2.5. Cycle Results

14.2.5.1. “Pass” or “Fail” display

14.2.5.2. End Pressure value

14.2.5.3. End air flow value

14.2.5.4. Channel display (A/B)

14.2.5.5. Total cycle time elapsed

14.2.5.6. Test result method (cycle time out or pressure trend)

14.2.5.7. “New Test” button

14.2.5.8. “Home” button

14.2.5.9. Print Icon

14.2.6. Print Cycle Results

14.2.6.1. Glove ID entry

14.2.6.2. Print button


14.2.7. Flow rate failure Popup

14.2.7.1. Instruction text


14.2.8. System Test

14.2.8.1. Pressure PV display

14.2.8.2. P(raw) display

14.2.8.3. Low Flow PV display

14.2.8.4. High Flow UP/DN arrows

14.2.8.5. Low Flow UP/DN arrows

14.2.8.6. Channel select

14.2.8.7. Mode of operation select

14.2.8.8. Time elapsed

14.2.8.9. Time elapsed reset button

14.2.8.10. Home button

14.2.8.11. Print Icon

14.2.9. Print System Test Results

14.2.9.1. Pressure PV at end of System Test




14.2.9.2. Air Flow PV at the end of System Test

14.2.9.3. Time Elapsed

14.2.9.4. Active channel display

14.2.9.5. OK button

14.2.9.6. Cancel button

14.2.10. Confirm Parameter entry Popup

14.2.10.1. Text to guide operator into parameter entry

14.2.10.2. YES button

14.2.10.3. No button

14.2.11. Parameters Home screen

14.2.11.1. Mode select (Pos. / Neg.)

14.2.11.2. Channel select A/B button

14.2.11.3. Pressure trend – ON/OFF with interlock popup window


14.2.11.5. Overview button

14.2.11.6. Print icon

14.2.11.7. Cycle functions button

14.2.11.8. Pressure Trending functions button

14.2.12. Parameters (value entry screen)

14.2.12.1. P (max) entry

14.2.12.2. P (overpressure) entry

14.2.12.3. P (threshold) entry

14.2.12.4. Flow (upper limit) entry

14.2.12.5. Flow (lower limit) entry

14.2.12.6. Time (max. inflate time) entry

14.2.12.7. Time (pressure stabilization) entry

14.2.12.8. Time (leak test) entry


14.2.12.10. Save button

14.2.12.11. ESC button

14.2.13. Parameters – Pressure trend

14.2.13.1. Time delay before pressure samples are taken T(delay)

14.2.13.2. Time between samples T(samples)




14.2.13.3. Number of readings that constitute a trend N (readings)


14.2.13.5. Save button

14.2.13.6. ESC button

14.2.14. Parameters View

14.2.14.1. Max. Pressure A / B

14.2.14.2. Overpressure A / B

14.2.14.3. Threshold Pressure A / B

14.2.14.4. Flow Upper Limit A / B

14.2.14.5. Flow Lower Limit A / B

14.2.14.6. Max. Time to Inflate A / B

14.2.14.7. Stabilization Time A / B

14.2.14.8. Leak Test Time A / B

14.2.14.9. Time delay before samples A / B

14.2.14.10. Time between samples A / B

14.2.14.11. Number of samples A / B

14.2.14.12. Back button


14.2.15. Parameter “changed” popup

14.2.15.1. Instructional text


14.2.16. Parameter “changing” popup


14.2.16.2. Yes button


14.2.17. Mode “changed” popup



14.2.18. Mode “changing” popup




14.2.19. Pressure Trend parameters “changed” popup






14.2.20. Pressure Trend parameters “changing” popup




14.2.21. Display Control

14.2.21.1. Brightness Up/Dn arrow buttons

14.2.21.2. Contrast Up/Dn buttons

14.2.22. Calibration entry confirm popup




14.2.23. Calibration Top Screen

14.2.23.1. Pressure Fixed Offset

14.2.23.2. Pressure Incremental offset

14.2.23.3. Lower input value

14.2.23.4. Upper input value


14.2.23.6. Calibrate system button


14.2.23.8. Calibration factors reset

14.2.24. Step 1 – Low Pressure factor



14.2.24.3. Time remaining


14.2.24.5. Enter button

14.2.25. Step 2 – High Pressure factor



14.2.25.3. Flow PV

14.2.25.4. Time remaining





14.2.25.6. Enter button

14.2.25.7. Up/Dn flow control arrow

14.2.26. Step 3 – Calibration factors review

14.2.26.1. Current Value: Fixed Offset

14.2.26.2. New Value: Fixed Offset

14.2.26.3. Current value: Incremental offset

14.2.26.4. New value: Incremental offset


14.2.26.6. Accept button

14.2.27. Calibration “Changing” Popup




14.2.28. Calibration “Changed” Popup



14.2.29. Calibration factors “resetting” Popup




14.2.30. Calibration factors “reset” confirmation Popup



14.2.31. Calibration failed Popup



14.2.32. Access denied Popup






15. Appendix A

Control Coils/OIT FlagsOIT flag PLC address PLC name Function description

WU_Done %M0001 FLG_wu_done Warm Up time out complete

Param_Save %M0004 FLG_Param_Save Parameter Save Pulse from OIT

A_Channel_active_Param %M0005 FLG_A_chnl_par A channel active for parameterscreen

Parameter_chng %M0013 FLG_Parameter_chng Bit indicates that a parameter haschanged.

Mode_chg_pulse %M0030 FLG_mode_chg_pulse Pulse that changes the pos/neg mode

Pos_mode_ON %M0031 FLG_pos_mode_on Positive mode is ON

Cycle_on %M0033 FLG_cycle_on Cycle is ON

Start_Stop_button %M0034 FLG_start_stop_button Start Stop button from OIT

Active_channel_chg %M0036 FLG_active_chnl_chg Command from OIT that changesthe active channel

Active_channel %M0037 FLG_active_channel Active channel during Leak Test

Home_from_CC %M0041 FLG_home_from_cc Home button from Cycle Controlscreen

Inflate_Fail %M0048 FLG_inflate_fail Inflate time out has occurred

Inflate_fail_ok %M0049 FLG_inflate_fail_ok Confirm from OIT that an inflatefailure has occurred.

Pass_Fail %M0092 FLG_pass_fail Pass or Fail indicator bit

Go_to_Results %M0094 FLG_go_to_results “Results” button from Cycle Controlscreen

ST_channel_change %M0097 FLG_st_chnl_change Channel select while in System Testmode

ST_channel %M0098 FLG_st_channel Active channel while in System Testmode

ST_inflate %M0100 FLG_st_inflate Inflate under System Test

ST_deflate %M0101 FLG_st_deflate Deflate under System Test

ST_tmr_rst %M0103 FLG_st_tmr_rst Pulse that resets the System Testtimer

ST_Store %M0104 FLG_st_store Pulse that stores the current valuesof Press, Flow

PT_active %M0112 FLG_pt_active Pressure Trending is active





PT_chg_pls %M0113 FLG_pt_chg_pls Pulse from OIT that changes the PTmode

Tst_method %M0131 FLG_test_method Cycle outcome method (Time out orPress. Trend)

Cal_changed_pls %M0133 FLG_cal_changed_pls Calibration has been changed –Pulse

Step1_Enter %M0134 FLG_step1_enter Enter button pulse from Step1 screen

Step2_Enter %M0135 FLG_step2_enter Enter button pulse from Step2 screen

Cal_on %M0142 FLG_cal_on Flag from OIT, calibration is on

Step1_done %M0145 FLG_step1_done Step 1 of calibration is done

Step2_done %M0146 FLG_step2_done Step 2 of calibration is done

Cal_reset_pls %M0152 FLG_cal_reset_pls Calibration factors reset pulse

Param_save_recvd %M0153 FLG_param_save_recvd Parameter save confirm

Mode_chg_pls_recvd %M0154 FLG_mode_chg_pls_recvd Mode change pulse confirm

PT_chg_pls_recvd %M0155 FLG_pt_chg_pls_recvd PT Change pulse confirm

Cal_chg_pls_recvd %M0156 FLG_cal_chg_pls_recvd Calibration changed pulse confirmed

Cal_reset_pls_recvd %M0157 FLG_cal_reset_pls_recvd Calibration reset pulse confirmed

New_test_button %M0160 FLG_newtest_button Button on Cycle Results screen

Cal_flow_flt %M0162 FLG_cal_flow_flt Flow rate failure has occurred

Store_glove_ID %M0164 FLG_store_glove_id Flag to store the glove ID value

Retrieve_glove_ID %M0167 FLG_Retrieve_glove_ID Flag to retrieve the glove ID value

Glove_ID_entry %M0169 FLG_glove_id_entry Tag that controls the Glove ID textentry format

Flow_Fail %M0170 FLG_flow_fail Flow Failure during leak test

Flow_Fail_Reset %M0171 FLG_flow_fail_reset Flow failure reset pulse from OITpopup

Active_Channel_stored %M0172 FLG_active_chnl_stored Stored channel from last cycle

Request_to_Param %M0173 FLG_request_to_param Request to go to Parameters screen

Request_to_Calib %M0174 FLG_request_to_calib Request to go to Calibration screen

OK_to_param %M0175 FLG_ok_to_param OK to go to Parameters

OK_to_calib %M0176 FLG_ok_to_calib OK to go to Calibration





Access_popup %M0177 FLG_access_popup Enables access warning popup

Param_active %M0178 PLG_param_active Bit that indicates that the parametermanagement function is active

Calib_active %M0179 FLG_calib_active Bit that indicates that the calibrationprocess is active

LT_active %M0180 FLG_LT_active Bit that indicates that the machine isin Leak Test mode

ST_active %M0181 FLG_ST_active Bit that indicates that the machine isin System Test mode

Button_1 %M0184 FLG_Button_1 Flag that controls the display of theHOME button of the Cycle ControlScreen

Button_2 %M0185 FLG_Button_2 Flag that controls the display of theRESULTS button of the CycleControl Screen

Cycle_off %M0186 FLG_Cycle_off The Leak Test cycle is OFF

ST_pos_on %M0188 FLG_ST_pos_on Positive mode during System Test isactive

OIT_param_esc %M0190 FLG_OIT_param_esc Resets parameter display on OIT tostored values

Registers/OIT dataOIT flag PLC

RegisterPLC name Function description

P_max_OIT %R0001 RG_p_max_oit Pressure Max. Entry in OIT - Parameters Screen

P_Max_A %R0003 RG_p_max_a Pressure Max. Parameter in PLC - A channel

P_ovr_OIT %R0004 RG_p_ovr_oit Over Pressure Entry in OIT – Parameters Screen

P_ovr_A %R0005 RG_p_ovr_a Over Pressure Parameter in PLC - A channel

P_thsld_OIT %R0006 RG_p_thsld_oit Pressure threshold in OIT – Parameters Screen

P_thsld_A %R0007 RG_p_thsld_a Pressure threshold parameter- A channel

P_Max_B %R0008 RG_p_max_b Pressure Max. Parameter in PLC - B channel

P_ovr_B %R0009 RG_p_ovr_b Over Pressure Parameter in PLC - B channel

P_thsld_B %R0010 RG_p_thsld_b Pressure threshold parameter- B channel






F_ul_OIT %R0011 RG_f_ul_oit Flow UL parameter in OIT – Parameters screen

F_ul_A %R0012 RG_f_ul_a Flow UL parameter in PLC - A channel

F_ul_B %R0013 RG_f_ul_b Flow UL parameter in PLC - B channel

F_ll_OIT %R0014 RG_f_ll_oit Flow LL parameter in OIT – Parameters screen

F_ll_A %R0015 RG_f_ll_a Flow LL parameter in PLC - A channel

F_ll_B %R0016 RG_f_ll_b Flow LL parameter in PLC - B channel

T_inf_OIT %R0017 RG_tm_inf_oit Time – Inflate max – in OIT – Parameters screen

T_inf_A %R0018 RG_tm_inf_a Time - Inflate max - A channel

T_inf_B %R0019 RG_tm_inf_b Time - Inflate max - B channel

T_stab_OIT %R0020 RG_tm_stab_oit Time – Stabilize – in OIT – Parameters screen

T_stab_A %R0021 RG_tm_stab_a Time - Stabilize - A channel

T_stab_B %R0022 RG_tm_stab_b Time - Stabilize - B channel

T_LT_OIT %R0023 RG_tm_lt_oit Time – Leak Test – in OIT – Parameters screen

T_LT_A %R0024 RG_tm_lt_a Time - Leak Test - A channel

T_LT_B %R0025 RG_tm_lt_b Time - Leak Test - B channel

Cycle_Status %R0026 RG_cycle_status Value that represents current cycle status

Msg_cyc_cntrl %R0028 RG_msg_cyc_cntrl Value determines message – Cycle Control screen

Flow_active %R0034 RG_flow_active Flowrate value from OIT

T_inflate_remain %R0039 RG_t_inflate_remain Timer that counts down the remaining time inCycle Control screen

T_elapsed %R0042 RG_t_elapsed Timer that counts up the total elapsed timedisplayed in the Cycle Control screen

Pressure_PV %R0046 RG_pressure_pv Value from AI converted to Pascals

Flow_PV %R0047 RG_flow_pv Value from AI converted to Sccm

Pressure_end %R0073 RG_press_end Pressure value at Leak test end

Flow_end %R0074 RG_flow_end Flow value at Leak test end

ST_timer %R0076 RG_st_timer Elapsed time during System Test

ST_pressure %R0077 RG_st_press Pressure value at the end of System Test

ST_flow %R0078 RG_st_flow Flow value at the end of System Test

T_delay_PT_A %R0081 RG_tm_dly_pt_a Time delay before press trend - A






T_delay_PT_B %R0082 RG_tm_dly_pt_b Time delay before press trend - B

T_delay_PT_OIT %R0083 RG_tm_dly_pt_oit Time delay before press trend - OIT

T_sample_PT_A %R0084 RG_tm_smpl_pt_a Time between samples - A

T_sample_PT_B %R0085 RG_tm_smpl_pt_b Time between samples - B

T_sample_PT_OIT %R0086 RG_tm_smpl_pt_oit Time between samples - OIT

N_read_PT_A %R0087 RG_N_read_pt_a Number of consecutive reads- A

N_read_PT_B %R0088 RG_N_read_pt_b Number of consecutive reads- B

N_read_PT_OIT %R0089 RG_N_read_pt_oit Number of consecutive reads- OIT

PT_pos_ctr %R0104 RG_pt_pos_ctr Counter of positive data samples

PT_neg_ctr %R0105 RG_pt_neg_ctr Counter of negative data samples

P_fo_stored %R0110 RG_p_fo_stored Pressure fixed offset stored value

P_fo_new %R0118 RG_p_fo_new Pressure fixed offset new value

P_pv_corr %R0129 RG_p_pv_corr Pressure corrected value

Step_1_ctr %R0262 RG_step_1_ctr Time counter of calibration step 1

Step_2_ctr %R0265 RG_step_2_ctr Time counter of calibration step 2

P_io_stored_10x %R0198 RG_p_io_stored_10x Pressure, Stored Fixed Offset, 10K, as an Integer.

P_io_new_10x %R0202 RG_p_io_new_10x Pressure, New Incremental Offset, 10K, as Integer

P_pv_lo_saved %R0246 RG_p_pv_lo_saved Saved Pressure input value - Low

P_pv_hi_saved %R0248 RG_p_pv_hi_saved Saved Pressure input value - High

Tm_elapsed_LT %R0250 RG_tm_elapsed_LT Elapsed time of last Leak Test Cycle

Glove_ID %R0252 RG_glove_ID Glove ID value

WU_Counter %R0259 RG_wu-counter Down counter of the Warm Up time delay function




16. Appendix BPLC Program structure

Main SectionRung Section Function description

2 Start Reset and Warm up functions (calls to subroutines)

6 HOME screen navigation Manages access to parameters and calibration according to the accesskeylock function

18 %AI control Section that controls and scales the analog input data

26 Inflate valve Inflate valve control

30 Deflate valve Deflate valve control

32 Pos/Neg control Controls the position of valves K3, K4 and K5

34 Pressure inlet valve K6

36 Vacuum outflow valve K7

38 Channel select Valves that control the channel A/B K8, K9

40 Pressure Value Correction Calculates the corrected value of the pressure based on the currentcalibration factors

Reset subroutineRung Section Function description

1 Reset function “First Scan” reset of numerous flags and registers.

Warm Up subroutineRung Section Function description

1 Time control Time down of a preset counter upon power up

Parameters subroutineRung Section Function description

2 Display control Display control of the parameters on the OIT

6 Max. Pressure Entry and display of the Maximum Pressure parameter

12 Over pressure Entry and display of the Over pressure parameter

17 Threshold Pressure Entry and display of the Threshold Pressure parameter




22 Flow Upper Limit Entry and display of the Flow Upper Limit param.

27 Flow Lower Limit Entry and display of the Flow Lower Limit param.

32 Max. Inflate Entry and display of the Max. Inflate parameter

37 Stabilization Time Entry and display of the Stabilization Time parameter

42 Leak Test Time Entry and display of the Leak Test Time parameter

47 Time Delay - PT Entry and display of the Time Delay Pressure Trend parameter

52 Time between samples Entry and display of the Time Between Samples Pressure Trendparameters

57 Number of Samples Entry and display of the Number of Samples Pressure Trendparameters

62 Change detection Detects whether a change has been made to any parameter so that itcan be flagged to the operator

86 Pos./Neg. Select Selection of positive or negative mode of operation

90 Pressure Trend on/off Selection of Pressure Trending activation

Leak Test Cycle subroutineRung Section Function description

3 Active channel select Selection of the active channel during the leak test cycle

5 Status control Controls the current status of the cycle.

13 Inflate phase control Controls the inflate phase

16 Inflate timers control Controls the timers display on the OIT and manages the timeoutalarm

23 Inflate press. Control Controls the inflate pressure parameters from OIT and comparing toPV

28 Stabilization phase – Timingcontrol

Controls the duration of the stabilization phase

35 Stabilization phase – Pulsingcontrol

Calculates the upper limit of the pressure pulse during stabilization

40 Leak Test Phase – Deflate Retrieves the P(threshold) value and deflates glove until value isreached.

46 Leak Test Phase – Duration Retrieve the timer values and controls the duration of the phase

53 Leak Test Phase – Flow Control Current flow rate monitoring and resulting cycle control

63 Time delay parameter Time delay handling at the beginning of the Pressure Trending modeof leak test

69 Sampling time handling Retrieves the programmed sampling time and generates the sampling




pulse.

75 Number of data samples handling Retrieves the parameter that determines the correct number of datasampling points

78 Pressure data point and trenddetermination

Retrieves a pressure data point and determines whether a trend exists.

94 Timer display control Controls the display of the T(elapsed) and T(remaining)

101 Current phase display control Controls the display of the current phase of the cycle

109 Navigation buttons control Controls the two navigation buttons of the screen

118 Message display control Controls the message display

125 Cycle Results Stored end values, determines the Pass/Fail condition of the test

135 Glove ID Manages glove ID storage and retrieval for display and printing

143 Cycle Start reset Reset the Leak Test Cycle upon Cycle Start

146 Reset pulse control

System Test subroutineRung Section Function description

1 Channel select – Timer Allows channel selection under ST mode – Elapsed timer function

6 Parameters store Stores the final parameters during system test to allow printing

Beeper Control subroutineRung Section Function description

1 On/OFF control Section that controls the ON/OFF functionality of the beeper

7 Frequency control Section that controls the frequency of the beeper

Calibration subroutineRung Section Function description

1 Mode set up Set up of the machine in calibration mode

5 Theoretical values Hard coded entry of theoretical values

7 Step 1 Obtain Pressure Low value

13 Step 2 Obtain Pressure High value

19 Flow Rate Check value of flow rate to make sure that it is within establishedlimits




24 Pressure factors Calculation of new pressure factors

28 New calibration factors store Store new calibration factors in permanent memory

32 Calibration factors reset Reset factors to zero.

36 Data display on OIT Preparation of the data for display on the OIT

Date post:	27-Mar-2018
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