Dynascan MediTEST User manual

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

D012-057-2 MediTEST User Guide Page ii
CONTACT INFORMATION
For technical assistance or servicing, in the initial instance please contact your
supplier.
Manufactured by:
Cambridge Sensotec Ltd.
29 Stephenson Road
St. Ives
Huntingdon
Cambridgeshire
PE27 3WJ
United Kingdom
Tel: [phone] - 462142
Email: [e-mail]
Website: www.dynascan.co.uk
© 2017 Cambridge Sensotec Ltd. All rights reserved. Document D012-057-2 (Oct 2018)
IMPORTANT
Every precaution has been taken in the preparation of this document. Cambridge Sensotec Ltd assumes no responsibility for errors
or omissions. Cambridge Sensotec Ltd assumes no liability for damages resulting from the use of the information contained in this
document. 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.
SUPPLIED BY:
CONTACT INFORMATION
THIS USER GUIDE APPLIES TO SYSTEM:
Serial Number:_____________________
Installed on: _____________________

D012-057-2 MediTEST User Guide Page iii
SAFETY INSTRUCTIONS
• The equipment must be connected to a protective earth or grounded power
supply.
• The equipment has been pre-set to operate only from a power supply
appropriate for location to which it was supplied. The ratings plate adjacent to
the power inlet indicates the power requirements.
• Do not exceed the specified fuse ratings; to do so may cause damage to the
equipment.
• Qualified personnel only, should service this equipment. Removing covers
may expose the user to dangerous voltages or other hazards.
• This manual should be read and understood in its entirety before installation
or operation of the MediTEST system.
SAFETY INSTRUCTIONS
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. Further, Cambridge
Sensotec Ltd reserves the right to revise this manual and to make changes to its con-
tent, at any time, without obligation to notify any person or entity of such revisions or
changes.
COPYRIGHT
No part of this manual may be reproduced or transmitted in any form or by any means,
electronic or mechanical, including photocopying and recording, for any purpose other
than the purchaser's personal use without the written consent of the copyright holder.

D012-057-2 MediTEST User Guide Page iv
SPECIFICATIONS
DISPLAY
8.4” 800 x 600 SVGA.
CONTROLS
Resistive touch screen virtual instrument.
Power switch.
TEST METHODS
Not limited (other than by storage capacity).
EXTERNAL INTERFACE
2 x USB 2.
1 x RJ45 Network port
PERFORMANCE
Sensitivity: 10 micron hole in a volume of 200mm3
Repeatability: +/- 10 of reading (assuming the same start conditions).
SIZE
Height = 500mm, Width = 640mm, Depth = 430mm.
WEIGHT
System = 65kg.
Vacuum pump = 12.7kg
OPERATING TEMPERATURE
0-40C (Storage 0-50C).
HUMIDITY
10 to 90% Non-condensing.
INGRESS PROTECTION
IP31 rated (with drawer closed).
POWER SUPPLY
As stated on ratings panel: 230V, 50 Hz, 350VA (peak).
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.
SPECIFICATIONS

D012-057-2 MediTEST User Guide Page v
DECLARATION OF CONFORMITY
Name of manufacturer or supplier: Cambridge Sensotec Limited
Full postal address including country of origin: 29 Stephenson Road
Saint Ives
Cambridgeshire
PE27 3WJ
United Kingdom
DECLARATION OF CONFORMITY
We Cambridge Sensotec under our sole responsibility declare that the product listed below:
Description Category: VACUUM LEAK TESTING DEVICE
Model Designation (s): M012-001, M012-002, M012-003, M012-004, M012-005, M012-008
Serial Number: ____________
Conforms to the principle safety objectives of the European Directive 2006/95/EC by application of the following
standard: EN 61010-1:2010
Year of affixation of the CE Marking 2017
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
DECLARATION OF CONFORMITY

D012-057-2 MediTEST User Guide Page vi
CONTENTS
CONTENTS
SECTION 1:
1.1
1.2
INTRODUCTION
Intended Use
Operating Principle
SECTION 2:
2.1
CONVENTIONS
Warnings Cautions and Notes
SECTION 3:
3.1
3.2
3.3
3.4
3.5
3.6
INSTALLATION
Unpacking
Positioning
Electrical Connections
Electrical Signal Connections
Pneumatic Connections
Switching On The System
SECTION 4:
4.1
4.2
4.3
4.4
MEDITEST DESCRIPTION
User Controls
The Test Chamber
Pack Contact Components
The User Interface
SECTION 5:
5.1
5.2
5.3
5.4
5.5
5.6
INITIAL CONFIGURATION
Before You Start Using The System
Start-Up
System Settings
The User Accounts Panel
Product Selector Panel
Test Method Panel
SECTION 6:
6.1
6.2
6.3
6.4
6.5
6.6
TESTING PACKS
Starting The System
Inserting Packs
The Test Cycle
The Test Results Screen
Terminating a Test Session
Test Cycle Error messages
SECTION 7:
7.1
7.2
TEST DATA AND BATCH RECORDS
Introduction To Batch Records
Closing And Opening A Batch Record
SECTION 8:
8.1
8.2
8.3
USER AND PASSWORDS
User Accounts Overview
User Account Settings
Creating A New User

D012-057-2 MediTEST User Guide Page vii
CONTENTS
CONTENTS
8.4
8.5
8.6
8.7
Setting User Privileges
Disabling A User Account
Disabled User Account
Retiring A User
SECTION 9:
9.1
9.2
TEST METHODS
Installed Test Method
Modifying Test Method Parameters
SECTION 10:
10.1
10.2
10.3
10.4
THE PRODUCT SELECTOR PANEL
Product Selector Overview
Creating A Product Definition
Product Definition Attributes
Product Selector Functions
SECTION 11:
11.1
11.2
11.3
11.4
11.5
THE SYSTEM SETTINGS PANEL
System Settings Overview
System Settings Discussed Elsewhere
Audit Trail and Metadata
Exit to Windows
Engineer Functions
SECTION 12:
12.1
12.2
12.3
12.4
12.5
SYSTEM CALIBRATION
Calibration Overview
Recalibration Settings
Load Cell Settings
Calibration Settings
System Leak Test
SECTION 13:
13.1
13.2
13.3
13.4
13.5
MAINTENANCE
Routine Maintenance
Emergency Maintenance
Preventative Maintenance
Cleaning
Fuse Replacement
SECTION 14:
14.1
14.2
SPARES AND ACCESSORIES
Critical Spares
Accessories
SECTION 15:
15.1
15.2
APPLICATION SPECIFIC NOTES
Pack Contents Components
Inserting Packs
SECTION 16:
16.1
CALIBRATION SETTINGS
Calibration

D012-057-2 MediTEST User Guide Page 1-1
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.
1.2 OPERATING PRINCIPLE
The pack under test is placed within the instrument's drawer unit. Custom made product nests may be
employed to contain and support the pack. The drawer is closed to form a gas tight seal. The test cycle
is initiated by pressing the start button.
During the test cycle, the air within the test chamber is evacuated. As the vacuum is applied, a
pressure difference is created between the inside of the pack and the vacuum chamber. This pressure
difference causes the pack to attempt to expand against the pressure plate situated above and in
contact with the pack. The pressure plate (and any nest) prevents the packs from expanding any
further, therefore the volume of the pack and its internal pressure will be held constant. As the vacuum
increases, the pressure difference increases and hence an increasing force generated between the
pressure plate (above) and the sensor platform (below). The evacuation is terminated at a
predetermined vacuum level.
Any change in the ratio of internal pack pressure to test chamber pressure, such as may be due to a
leak will result in a change in the force developed between the pressure plate and the sensor platform.
The initial force reading at the end of the evacuation phase, and any subsequent change thereof
during the test phase, form the basis of the leak detection principle.
INTRODUCTION
SECTION 1: INTRODUCTION
This section describes:
• What the MediTEST system should be used for
• The operating principle
• MediTEST unit features and benefits

D012-057-2 MediTEST User Guide Page 2-1
2.1 WARNINGS, CAUTIONS AND NOTES
A WARNING indicates a potentially hazardous situation, which if not avoided may
result in injury or death.
A CAUTION indicates where a failure to observe an instruction or precaution could
result in equipment damage or undesirable operation.
 NOTE: A NOTE indicates important information that helps the operator make better use of the
equipment.
CONVENTIONS
SECTION 2: CONVENTIONS
This section describes:
• Warnings, cautions and notes
WARNING
CAUTION

D012-057-2 MediTEST User Guide Page 3-1
3.1 UNPACKING
The MediTEST unit may require mechanical handling to remove it from it’s packing
crate if it exceeds personal lifting limits. Do not lift by the drawer handle. See fig. 3.1
When unpacked the user should take time to familiarise themselves with the components. It is
recommended that this user guide is read thoroughly before proceeding. The instrument is supplied
with the components listed on the delivery note. If any component is missing please contact your
supplier.
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.
If a separate vacuum pump is supplied, this should be positioned such that the vacuum line is as short
as practical. See Fig. 3.1
 NOTE: The power supply connector and switch must be accessible in case of an emergency.
 NOTE: The regulator (or air supply) outlet control must be accessible in case of an emergency.
Refer to Fig. 3.2, this shows the rear panel general arrangement of the electrical and pneumatic
connections.
INSTALLATION
SECTION 3: INSTALLATION
This section describes:
• How to unpack the MediTEST
• Placement of the MediTEST unit
• Connection to a power supply
• Connection to a compressed air supply
WARNING

D012-057-2 MediTEST User Guide Page 3-2
INSTALLATION
Do not lift by this handle.
WARNING
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

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3.3 ELECTRICAL CONNECTIONS
3.3.1 ELECTRICAL SUPPLY
An IEC power lead must be connected to the inlet (see figure 3.4) and to an AC supply as specified on
the rating plate located next to the power cable inlet (see figure 3.4). The IEC connector is a
disconnect device, and must therefore be totally accessible in an emergency.
This equipment must be connected to a protective earth (grounded power supply).
3.3.2 POWER SUPPLY FUSE
There is a single fuse fitted inside the fuse holder on the rear panel. Replace with the
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. It is a rocker type switch and is labelled 1 for ON and 0
for OFF. It is advisable to shut the unit down, and switch it off when not in use.
3.3.4 VACUUM PUMP POWER SUPPLY
Connect the vacuum pump to this outlet. This is a dedicated switched output and must not be used for
any other purpose.
INSTALLATION
WARNING
CAUTION
3.4 ELECTRICAL SIGNAL CONNECTIONS
There are two USB 2 connectors. The facilitate the connection of ancillaries such as Printer, Keyboard
or mouse. If more than two USB devices are required at the same time, a USB splitter may be
employed.
Dual USB 2 connectors.
Connect an approved
vacuum pump here.
Figure 3.3

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3.5 PNEUMATIC CONNECTIONS
3.5.1 COMPRESSED AIR SUPPLY
An air supply in the range 5.5 to 6.5 bar (6 bar is recommended) should be connected to the Air Supply
connection port on the rear panel. The air supply must be dry and oil free. The push-fitting takes a
6mm tube. Refer to Fig 3.5.
The air supply to the system, must be able to be isolated in case of an emergency.
3.5.2 VACUUM SUPPLY
The vacuum supply port is a push-fitting and takes an 8mm hose. This is connected to the
corresponding fitting on the vacuum pump unit. 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.
INSTALLATION
WARNING
WARNING
6mm push-fit connection.
8mm push-fit connection.
Figure 3.4

D012-091-2 MediTEST User Guide Page 3-5
3.6 SWITCHING ON THE SYSTEM
Ensure Sections 3.1 to 3.5 have been completed satisfactorily.
Switch the compressed air supply ON (This will be at the disconnect device).
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.
INSTALLATION
CAUTION
Figure 3.6
Figure 3.5

D012-057-2 MediTEST User Guide Page 4-1
MEDITEST DESCRIPTION
SECTION 4: MEDITEST DESCRIPTION
This section describes:
• User Controls
• Pack contact components
• Test chamber components
• Front panel controls
4.1 USER CONTROLS
The MediTEST is designed to be simple to operate with three basic controls.
Drawer Unit - Allows
access to the product test
stations.
Touch screen user
interface.
Rear panel Power switch.
Figure 4.1
Figure 4.2

D012-057-2 MediTEST User Guide Page 4-2
4.2 THE TEST CHAMBER
The test chamber is an airtight enclosure that contains the Sensor assemblies, each of these
comprises the pack presentation and sensing components. The Test Chamber is placed under
vacuum in normal operation.
The internal configuration is described below, refer to Figure 4.3.
4.2.1 THE DRAWER UNIT
The drawer front forms the test chamber closure and produces a vacuum seal. The Drawer Front is
linked to the Product Platform on each Sensor assembly. When the Drawer is opened it retracts the
Product Platform so that it may be loaded.
4.2.2 THE PRODUCT PLATFORM
The Product Platform supports the pack (and any nest) when it is under test. This is connected to the
force sensor (load cell) by a linear slide. When the Drawer is closed (to enable a test) it becomes
decoupled from the Drawer Front Link. This ensures isolation during the test cycle.
As the Product Platform is part of the sensing system, do not press down or apply
excessive force when it is in the open position.
4.2.3 THE PRESSURE PLATE
The internal Pressure Plate provides a reaction to the pack when it expands under test. The pressure
plate is self-adjusting to compensate for varying pack heights. It locks into position when a test is
initiated. The Pressure Plate is not normally visible.
MEDITEST DESCRIPTION
CAUTION
Pressure Plate -
internal.
Test Station Product
Platform (1 of 4).
Sensor Assembly (1 of 4).
Drawer Unit.
Figure 4.3

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4.3 PACK CONTACT COMPONENTS
4.3.1 PRODUCT PLATFORM PORVAIR
The Product Platform is covered in a porous material (Porvair mat). This allow any air from a fugitive
leak to pass unhindered. The pack to be tested is place directly on the mat. Should the mat become
contaminated or deformed, it may be replaced. Your supplier can assist you in this respect.
4.3.1 PRODUCT NESTS
It is not generally necessary to employ a product nest when testing a sample, however it may be
advantageous to use a product nest where a sample is likely to rupture (due to a weak seal) and the
nest would provide containment in respect of the spread product.
Product nests may also be employed to ensure consistent location within the testing area.
When a nest is employed it rests on the Product Platform (base of the drawer unit) and can be shaped
to fit a particular pack. If there is a need to test packs of different sizes (plan forms) sequentially, then
nests can be used for each type of pack.
Where the use of Product Nests is dictated, they will be supplied as part of the system (See Section 15
for your specific application). For requirements subsequent to the installation of the system, they can
be supplied as part of a Method Development package. Customers can also machine or source their
own. Your supplier can assist you in this respect.
4.3.2 PRESSURE PLATE PORVAIR
The internal pressure plate provides a reaction to the pack when it expands under test. It is also fitted
with a Porvair mat that allows the transmission of air from a leaking pack. If the mat becomes
contaminated or deformed, it may be replaced. Your supplier can assist you in this respect.
MEDITEST DESCRIPTION
Porvair material. Is held in place
with double-sided adhesive. If a
Product Nest is employed, Porvair
will not be required.
Porvair material is attached to the
Pressure Plate (normally out of
view). It is held in place with double
-sided adhesive.
Figure 4.4

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4.4 THE USER INTERFACE
4.4.1 FRONT PANEL TOP LEVEL SCREEN
After powering on, the system will display the FRONT PANEL screen (Fig 4.5). This is the default
(boot) screen and allows the operator to execute the currently programmed test method. All other
panels and functions are accessed from here.
All routine production level testing can be carried out from the FRONT PANEL without the operator
having to access any other function.
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.
• Parameters are entered by touching the indicator box and pressing the increment (decrement)
control for a single step or holding it down for an auto-increment (decrement) action.
• If a keyboard is also connected, the control can be highlighted and the value entered manually.
See Section 5.1 for the software navigational structure.
MEDITEST DESCRIPTION
Figure 4.5

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MEDITEST DESCRIPTION
4.4.3 THE MENU PANEL
The default screen is the FRONT PANEL, other functions are accessed by pressing the MENU button
on the FRONT PANEL. Figure 4.6 shows the MENU Panels.
Pressing on a button accesses the function. This will require the user to select their username and
enter their password. If the User does not have the correct permission, their name will not be displayed.
Figure 4.6
4.4.3.1 SYSTEM SHUTDOWN
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

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MEDITEST DESCRIPTION
4.4.4 VIRTUAL INSTRUMENT CONTROLS
The panel controls may be operated via the touch screen or with a mouse and/or a keyboard.
Controls in this colour are navigational.
Controls in this colour cancel any changes before exiting.
Controls in this or this colour activate a function.
Controls in this colour halt of close a process.
Controls in this colour acknowledge or accept and action
Meta-data selection controls look like this:
Functions are selected from a drop-down menu.
Parameter input controls look like this:
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