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Dynascan MediTEST User Manual

Seal integrity & leak detection systems
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D012-057-2
USER GUIDE
M012 MediTEST
FOR USE WITH PART NUMBERS:
M012-003 (4 Sensor - External Vacuum Pump)
Seal Integrity & Leak Detection Systems

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  • Page 1 D012-057-2 USER GUIDE M012 MediTEST FOR USE WITH PART NUMBERS: M012-003 (4 Sensor - External Vacuum Pump) Seal Integrity & Leak Detection Systems...
  • Page 2 Cambridge Sensotec Ltd specifically disclaims any express or implied warranties of merchantability or fitness for any particular purpose. Further, Dynascan reserves the right to make changes to this publication at any time, without prior notification to any person or entity.
  • Page 3 • This manual should be read and understood in its entirety before installation or operation of the MediTEST system. DISCLAIMER Cambridge Sensotec Ltd makes no representations or warranties with respect to the contents or use of this manual and specifically disclaims any express or implied war- ranties of merchantability or fitness for any particular purpose.
  • Page 4 Vacuum pump 230V, 50 Hz , 250VA AIR SUPPLY 5.5bar to 6.5bar (6 bar typ.) @ 200l/min. (Internal vacuum generator variant) MANUFACTURING STANDARDS EN 61010-1:2010. Casework - AISI 304 Stainless steel. Test Chamber - HE30 Aluminium, hard anodised. D012-057-2 MediTEST User Guide Page iv...
  • Page 5 Conforms to the protection requirements of European Directive 2004/108/EC by application of the following stand- ard: EN 61326: 2006 (industrial). Place of issue: St.Ives Name of authorised Representative: Mark Swetnam Position of authorised Representative: Managing Director Signature of authorised representative Date 18 October 2017 D012-057-2 MediTEST User Guide Page v...

  • Page 6: Table Of Contents

    Test Cycle Error messages SECTION 7: TEST DATA AND BATCH RECORDS Introduction To Batch Records Closing And Opening A Batch Record SECTION 8: USER AND PASSWORDS User Accounts Overview User Account Settings Creating A New User D012-057-2 MediTEST User Guide Page vi...
  • Page 7 Preventative Maintenance 13.4 Cleaning 13.5 Fuse Replacement SECTION 14: SPARES AND ACCESSORIES 14.1 Critical Spares 14.2 Accessories SECTION 15: APPLICATION SPECIFIC NOTES 15.1 Pack Contents Components 15.2 Inserting Packs SECTION 16: CALIBRATION SETTINGS 16.1 Calibration D012-057-2 MediTEST User Guide Page vii...

  • Page 8: Introduction

    MediTEST unit features and benefits 1.1 INTENDED USE The MediTEST is a series of non-destructive leak detectors for sealed flow wrapped flexible packs, pouches or trays. They are intended for use in pharmaceutical, medical device and food production environments. The instruments detect pinhole size leaks in the pack material where it has been punctured, tracking leak paths in seal areas where the material may have become wrinkled and seals or material that may be mechanically weak.

  • Page 9: Conventions

    A CAUTION indicates where a failure to observe an instruction or precaution could CAUTION result in equipment damage or undesirable operation.  NOTE: A NOTE indicates important information that helps the operator make better use of the equipment. D012-057-2 MediTEST User Guide Page 2-1...

  • Page 10: Installation

    3.2 POSITIONING The MediTEST unit should be positioned, such that it is level and subjected to minimal vibration or movement and such that the front panel can be easily seen. There should be rear clearance to allow the connection of power and air supplies.
  • Page 11 INSTALLATION WARNING Do not lift by this handle. External Vacuum Pump. This should be placed on the ground. Keep the vacuum line as short as practicable. Figure 3.1 Adjust for level. Figure 3.2 D012-057-2 MediTEST User Guide Page 3-2...

  • Page 12: Electrical Connections

    There is a single fuse fitted inside the fuse holder on the rear panel. Replace with the CAUTION same specification fuse. For the MediTEST the fuse type and rating are T type (Anti-surge) with a 5 Amp rating. 3.3.3 MAINS SWITCH The mains switch is located on the rear panel.

  • Page 13: Pneumatic Connections

    This hose should be kept short as possible. Any suitable source of vacuum may be connected here. Never connect a pressure source to the Vacuum Supply inlet. WARNING 8mm push-fit connection. 6mm push-fit connection. Figure 3.4 D012-057-2 MediTEST User Guide Page 3-4...

  • Page 14: Switching On The System

    Switch the electricity supply ON (see fig 3.5). The Control Computer will now boot-up and the FRONT PANEL screen (see fig 3.6) will be displayed - this may take a number of seconds. Figure 3.5 Figure 3.6 D012-091-2 MediTEST User Guide Page 3-5...

  • Page 15: Meditest Description

    • Test chamber components • Front panel controls 4.1 USER CONTROLS The MediTEST is designed to be simple to operate with three basic controls. Touch screen user interface. Rear panel Power switch. Drawer Unit - Allows access to the product test stations.

  • Page 16: The Test Chamber

    It locks into position when a test is initiated. The Pressure Plate is not normally visible. Sensor Assembly (1 of 4). Pressure Plate - internal. Drawer Unit. Test Station Product Platform (1 of 4). Figure 4.3 D012-057-2 MediTEST User Guide Page 4-2...

  • Page 17: Pack Contact Components

    Pressure Plate (normally out of view). It is held in place with double -sided adhesive. Porvair material. Is held in place with double-sided adhesive. If a Product Nest is employed, Porvair will not be required. Figure 4.4 D012-057-2 MediTEST User Guide Page 4-3...

  • Page 18: The User Interface

    Figure 4.5 4.4.1 NAVIGATION AND DATA ENTRY The MediTEST system employs a touch screen user interface: • Touching on a control will cause it to activate. • If a mouse is connected the user can hover over a control and click on it to activate it.
  • Page 19 The system may be shut-down from the MENU panel, pressing the SHUT DOWN button invokes a dialog (Fig 4.7). Press EXIT to shutdown the system. This will exit Windows and switch off the computer. Figure 4.7 D012-057-2 MediTEST User Guide Page 4-5...
  • Page 20 They are can be modified by pressing the up/down buttons, or by touching on the box and entering via a keyboard. Check box controls: ON looks like this Check box controls: OFF looks like this D012-057-2 MediTEST User Guide Page 4-6...

  • Page 21: Initial Configuration

    The configuration setting relate to the system specified on page ii and were correct at OPERATING CAUTION SYSTEM the time of handover to the customer. FRONT PANEL RESULTS MENU PRODUCT TEST DATA USER SYSTEM SELECTOR ACCOUNTS SETTINGS METHODS MANAGER D012-091-2 MediTEST User Guide Page 5-1...

  • Page 22: Start-Up

    This may indicate some product identification information. This will be checked for validity. You may be asked for a User Name (Administrator) and Password during the following steps. PARAMETER SETTING User Name Method Product Batch D012-057-2 MediTEST User Guide Page 5-2...

  • Page 23: System Settings

    SETTING Test Vacuum Calibration (days) Reminder (days) PARAMETER SETTING Vac Drop PARAMETER SETTING Time Out Password Expire Release Vac. Password Retries PARAMETER SETTING Password Min Length Delimiter Auto Logoff Case Sensitive Logon to Test D012-057-2 MediTEST User Guide Page 5-3...
  • Page 24 INITIAL CONFIGURATION 5.3 SYSTEM SETTINGS - CONTINUED Access the SYSTEM SETTINGS screen. PARAMETER SETTING Export Path Copy Path PARAMETER SETTING Data File Format Delimiter D012-057-2 MediTEST User Guide Page 5-4...
  • Page 25 LOAD CELL 1 LOAD CELL 2 Sensor Voltage Sensor Voltage Force Value Force Value Adjusted Force Adjusted Force Set Zero Set Zero Set Mid Set Mid Set Span Set Span Use Adjusted Calibration Use Adjusted Calibration D012-057-2 MediTEST User Guide Page 5-5...
  • Page 26 VACUUM SENSOR CALIBRATION screen. It should correspond to the settings indicated in the tables below. PARAMETER SETTING VACUUM SENSOR Sensor Voltage Vacuum Value Adjusted Vacuum Set Zero Set Mid Set Span Use Adjusted Calibration D012-057-2 MediTEST User Guide Page 5-6...

  • Page 27: The User Accounts Panel

    USER ACCOUNTS screen, As this screen displays settings corresponding to the selected user, their setting cannot be tabulated. The Administrator will have full access to all functions and all Function indicator will = PASSWORD. D012-057-2 MediTEST User Guide Page 5-7...

  • Page 28: Product Selector Panel

    (any other product will not). PARAMETER SETTING Select Product Description Uses Method Current Batch PARAMETER SETTING Trial (No Batch Record) Print Result (button) Print Report (button) Show Results (button) D012-057-2 MediTEST User Guide Page 5-8...

  • Page 29: Test Method Panel

    Ensure it corresponds with the table below. PARAMETER SETTING Method Name PARAMETER SETTING Target Vacuum Stabilise Time Leak Test Time Leak Limit Gross Level Trial (Not Saved) D012-057-2 MediTEST User Guide Page 5-9...

  • Page 30: Testing Packs

    If you are using a printer ensure it is connected to a free USB socket and is switched on. Switch-on power to the MediTEST (at the rear IEC socket). The system will take approximately 20 seconds to activate before the FRONT PANEL is displayed as in Fig 6.1.
  • Page 31 Allows a Batch Record to be closes and a new one opened. Access authority Press to view and print the AUDIT LOG - Log-in free. See Section 6.1.2. These fields are populated from the PRODUCT SELECTOR. Figure 6.2 D012-057-2 MediTEST User Guide Page 6-2...
  • Page 32 CANCEL to exit. Figure 6.4 shows an example Audit Log, one is created every day. To print the log press PRINT (ensure a printer is on-line) or CLOSE to exit. Figure 6.3 Figure 6.4 D012-091-2 MediTEST User Guide Page 6-3...

  • Page 33: Inserting Packs

    The test positions are numbered 1 to 4 (left to right) and correspond to Pack 1 to Pack 4 on the FRONT PANEL screen. Pack position Number 1 Product Platform Drawer Front Figure 6.5 D012-057-2 MediTEST User Guide Page 6-43...
  • Page 34 Place the pack centrally on the Product Platform. If a Product Nest is employed insert the pack into the receptacle. Do not apply any pressure to the Product Platforms. CAUTION Figure 6.6 Close the drawer slowly until it locks in position. On the FRONT PANEL press the button. START TEST D012-057-2 MediTEST User Guide Page 6-5...

  • Page 35: The Test Cycle

    9) If excessive force is generated a sensor over-range error can occur, in which case the test will be aborted - See 6.6. Vacuum level increases (blue pointer) to reach target (green pointer). Force values Non-active buttons should increase. greyed-out. Indicates the EVACUATION phase. Figure 6.7 D012-057-2 MediTEST User Guide Page 6-6...
  • Page 36 The Pack indicators now to show the change in force that may indicate a leaking pack. 2) After the DECAY TEST phase is the VENT phase. Bar-graph indicates DECAY TEST phase force values. Figure 6.8 D012-057-2 MediTEST User Guide Page 6-7...
  • Page 37 RESULTS INDICATOR. This will invoke the RESULTS PANEL. See Section 6.4. Press one of these buttons to view the associated RESULTS SCREEN. Figure 6.7 Press this buttons to return to the FRONT PANEL - you can select another result to view. Figure 6.8 D012-057-2 MediTEST User Guide Page 6-8...

  • Page 38: The Test Results Screen

    Refer to this in the Press to save the current screen image. A Data Manager. dialog will open to facilitate this. Press to print the current screen image. Ensure a printer is online. Figure 6.9 D012-057-2 MediTEST User Guide Page 6-9...

  • Page 39: Terminating A Test Session

    To log-out of the system press the button on the LOG OUT button. This does not require a password. Press to LOG-OUT and exit to the Windows log-on screen. Figure 6.10 D012-057-2 MediTEST User Guide Page 6-10...

  • Page 40: Test Cycle Error Messages

    The following error messages may be displayed during the running of a test cycle. If an error is posted, take the suggested action, then press and restart the test. If the suggested action does not clear the problem, consult Dynascan for advice or service. ERROR MESSAGE CAUSE...

  • Page 41: Test Data And Batch Records

    It is possible to close a Batch Record without opening a new one. It is still possible to conduct a test, but no data will be recorded. A new Batch Record can be created at a later date. D012-057-2 MediTEST User Guide Page 7-1...

  • Page 42: Closing And Opening A Batch Record

    If you do not want to open a new Batch record at this time (and have selected NO) a dialog box will open stating No data will be saved. The system will allow tests to be conducted with no open Batch Record, however not test data will be recorded. D012-057-2 MediTEST User Guide Page 7-2...

  • Page 43: User And Passwords

    SOP documentation. If a user is denied access to a function, then their name does not appear in the drop-down list for that function. D012-057-2 MediTEST User Guide Page 8-1...

  • Page 44: User Account Settings

    Specifies the minimum number of characters a password must comprise. START TEST button an be made password exempt, to do so uncheck the box (Appears white). Figure 8.1 D012-057-2 MediTEST User Guide Page 8-2...

  • Page 45: Creating A New User

    To re-enable their account: Open the USER ACCOUNTS screen. Select the USER NAME from the dropdown menu. Touch on the DISABLE USER check box (changes from red to white fill colour. D012-057-2 MediTEST User Guide Page 8-3...

  • Page 46: Retiring A User

    Press the RETIRE USER button. This dialog box will open: Press to continue (or to abandon). This dialog box will then open: Press to continue (or to abandon), The user is now retired. D012-057-2 MediTEST User Guide Page 8-5...

  • Page 47: Test Methods

    • 9.1 INSTALLED TEST METHOD MediTEST system is generally supplied with a workable test method. If the system is being installed by Dynascan a test method may also be developed at this time. Dynascan will always be able to provide advice on developing a new method.

  • Page 48: Modifying Test Method Parameters

    8800 9600 10400 11200 6000 12000 15000 16500 18000 19500 21000 12000 24000 30000 33000 36000 39000 42000 20000 40000 50000 55000 60000 65000 70000 10400 11200 32000 64000 80000 88000 96000 Figure 9.1 D012-057-2 MediTEST User Guide Page 9-2...
  • Page 49 Generally the harder the vacuum the less the adiabatic effect has on the result. The Figure 9.2 illustrates this effect. Figure 9.2 D012-091-2 MediTEST User Guide Page 9-3...
  • Page 50 Lim it of detection leak plot. Good pack plot 10 11 12 13 14 15 16 17 18 19 20 Graph show s data plot for Pack No. one channel only Figure 9.3 D012-057-2 MediTEST User Guide Page 9-4...
  • Page 51 Achieve the initial force, but may then lose pressure during stabilisation (medium sized leak or sudden failure). Have abnormally low air content, and therefore cannot expand enough to produce the required initial force in the specified evacuation time. Figure 9.4 D012-057-2 MediTEST User Guide Page 9-5...

  • Page 52: The Product Selector Panel

    Product Name. 10.2 CREATING A PRODUCT DEFINITION In the MENU screen select PRODUCT SELECTOR. Press CREATE PRODUCT. This dialog box will open. Press to continue or to cancel. D012-052-2 MediTEST User Guide Page 10-1...
  • Page 53 This dialog box will then open. Enter the new Product Name and press ENTER CANCEL abandon). The new product name must not already exist, otherwise this error message will be posted. D012-091-2 MediTEST User Guide Page 10-2...

  • Page 54: Product Definition Attributes

    Section 7.2. CURRENT BATCH indicator is informational only. SELECT PRODUCT dropdown allows a pre-existing product to be selected and used for the current test cycle. D012-091-2 MediTEST User Guide Page 10-3...

  • Page 55: The System Settings Panel

    Administrator is advised to deny access to this panel when setting user privileges. System parameter settings are critical to the system operation and should only CAUTION modified by trained personnel, or under the direction of Dynascan. 11.2 SYSTEM SETTINGS DISCUSSED ELSEWHERE There are, some functions on the...
  • Page 56 The Audit files may be copied (in a human readable form) to the destination as set in the COPY PATH control. The path should be entered into this field. Figure 11.1 11.3.2 RESULTS FILES DELIMITER The delimiter used in human readable results files should be set here. Figure 11.2 D012-057-2 MediTEST User Guide Page 11-2...
  • Page 57 A second dialog screen will open to set the required destination. The file name and destination will be indicated, these can however be changed. Press SAVE. Pressing CANCEL in either screen will abandon the action. Figure 11.3 Figure 11.4 D012-091-2 MediTEST User Guide Page 11-3...

  • Page 58: Exit To Windows

    Figure 11.5 Figure 11.6 11.5 ENGINEER FUNCTIONS The functions listed below are for system engineering purposes. They should only be accessed by trained personnel, and under the instruction of Dynascan. D012-057-2 MediTEST User Guide Page 11-4...

  • Page 59: System Calibration

    The MediTEST is factory calibrated with instruments traceable to national standards. Recalibration may be carried out on the customer’s site during a system service strip-down. Users are able to verify the calibration status of the MediTEST by the use of a System Verification Kit - Type 1 (M012-031) available from Dynascan.

  • Page 60: Recalibration Settings

    The Load Cell Settings parameters are critical to the system function. They should not be modified (unless under the direction of Dynascan). They should be as is listed in section 5.3 Do not modify these settings, If this screen is accessed, press CANCEL to exit safely.

  • Page 61: Calibration Settings

    It is possible to view the calibration settings for the load-cells and vacuum sensor. The displayed values should correspond to those stated in Sections 5.3.1 and 5.3.2. If they seem to be substantially at variance, contact Dynascan for advice. To check if the calibration settings are reasonable (for confidence) enter the...

  • Page 62: System Leak Test

    Before performing a System Leak Test, ensure valid test parameters are entered (similar to Fig 12.3). These should be as listed in section 5.3. If they are not, or there is no documentation relating to their current setting, then contact Dynascan for advice. Figure 12.6 Figure 12.5...

  • Page 63: Maintenance

    13.2 EMERGENCY MAINTENANCE Where customers require their own personnel to perform emergency maintenance, training can be provided by Dynascan or your supplier. Only trained personnel should attempt any repair or calibration activities. A recommended spares list can be supplied on the customer’s request.

  • Page 64: Cleaning

    There are two mains (power) fuses within the mains inlet/fuse/switch/filter assembly on the rear panel of the instrument. The fuse is a T5A / 250V 20 mm type. ONLY REPLACE THE FUSE WITH ONE OF THE SAME TYPE AND RATING! WARNING D012-057-2 MediTEST User Guide Page 13-2...

  • Page 65: Spares And Accessories

    Critical spare parts • Accessories (current and in development) • 14.1 CRITICAL SPARES The following is a list of recommended spars that may be kept. SPARES DESCRIPTION NUMBER PART NO. 14.2 ACCESSORIES ACCESSORY DESCRIPTION PART NO. D012-057-2 MediTEST User Guide Page 14-1...

  • Page 66: Pack Contents Components

    Product Platform and are located by slots in their bases. Note that these have a front to back orientation and should be replaced correctly. Note position of locating slots. Figure 15.1 D012-057-2 MediTEST User Guide Page 15-1...

  • Page 67: Inserting Packs

    CAUTION The test positions are numbered 1 to 4 (left to right) and correspond to Pack 1 to Pack 4 on the FRONT PANEL screen. Insert sample into nest aperture. Product Nest Figure 15.2 D012-057-2 MediTEST User Guide Page 15-2...

  • Page 68: Calibration

    CONFIGURATION SETTINGS SECTION 16: CALIBRATION SETTINGS 16.1 CALIBRATION The MediTEST vacuum sensor and load cells are ranged against a calibrated vacuum meter, and calibrated test weights. The MediTEST should not be regarded as weighing or vacuum measuring system. 16.1.1 CALIBRATION SETTINGS - AS DELIVERED This is to certify that The Vacuum sensor and Load Cells were calibrated as detailed below with equipment traceable to national standards.
  • Page 69 M2 Test Weight 500g (1) M2 Test Weight 1000g (2) M2 Test Weight 2000g (3,4,5,&6) Applied Mass Load Cell 1 Load Cell 2 Load Cell 3 Load Cell 4 Applied Vacuum Sensor Output Scaled Value (mbar) (mbar) D012-057-2 MediTEST User Guide Page 16-2...
  • Page 70 M2 Test Weight 500g (1) M2 Test Weight 1000g (2) M2 Test Weight 2000g (3,4,5,&6) Applied Mass Load Cell 1 Load Cell 2 Load Cell 3 Load Cell 4 Applied Vacuum Sensor Output Scaled Value (mbar) (mbar) D012-057-2 MediTEST User Guide Page 16-3...

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