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MACHINE SERIAL NUMBER:

USER MANUAL

D106-016-008

MODEL NUMBER
T106-001-006

VISIONSCAN

TOOL-LESS, NON-DESTRUCTIVE
INSPECTION DEVICE FOR BLISTER PACKS

Original
SEPHA LTD
Unit 25 Carrowreagh Business Park Carrowreagh
Road, Dundonald Belfast BT16 1QQ Northern
Ireland United Kingdom
T: +44 (0)28 9048 4848
F: +44 (0)28 9048 0890
E: info@sepha.com
W : www.sepha.com
VISIONSCAN USER MANUAL

DISCLAIMER

Every precaution has been taken in the preparation of this document. Sepha Ltd
assumes no responsibility for errors or omissions. Sepha Ltd specifically disclaims any
express or implied warranties of merchantability or fitness for any particular purpose.
Further, Sepha Ltd reserves the right to make changes to this publication at any time,
without prior notification to any person or entity.

DOCUMENT HISTORY

REV DATE RELEASED BY DESCRIPTION


001 19-MAY-2017 Jonathan Todd First release
Included disaster recovery section.
002 07-JUL-2017 Jonathan Todd Updated screens to reflect latest software
A106-020-001.0
Reports section elaborated. Added section
7.1.1 calibration verification. Added section
003 02-OCT-2017 Jonathan Todd 11 alarm list. Drawing A106-021 revised as
per CNR648. Changes to coincide with
CNR649.
Updated disaster recovery section to new
004 07-NOV-2017 Jonathan Todd
SQL backup software.
Update model number to T106-001-004 as
005 01-DEC-2017 Jonathan Todd
per CNR654.
Update model number to T106-001-006 as
006 18-JAN-2018 Adam Osborne
per CNR656
Update for software A106-020-001.2 as
007 12-FEB-2018 Jonathan Todd
per CNR657.
Updated branding. Update for CNR668,
008 24-OCT-2018 Jonathan Todd
new case and aluminium top plate.

DOCUMENT APPROVAL

The undersigned have completely and thoroughly reviewed the specified document.
NAME POSITION FUNCTION SIGNATURE DATE

Document
Jonathan Todd Product Engineer 24-OCT-2018
Owner

Operations Technical
Colin McLean 24-OCT-2018
Manager Review

Head of
Philip Cooper QA Review 24-OCT-2018
Technology

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CONTENTS
DISCLAIMER....................................................................................................... 2
DOCUMENT HISTORY .......................................................................................... 2
DOCUMENT APPROVAL ....................................................................................... 2
TECHNICAL SPECIFICATION ........................................................................ 6
WARNING SYSTEM NOTICE ........................................................................ 7
TYPOGRAPHICAL CONVENTIONS ................................................................. 7
SAFETY .................................................................................................... 7
INTRODUCTION ........................................................................................... 8
OVERVIEW ............................................................................................... 8
OPERATING PRINCIPLE .............................................................................. 9
HIGH LEVEL DESCRIPTION ....................................................................... 10
FEATURES AND BENEFITS ........................................................................ 10
LIMITATIONS ......................................................................................... 11
INSTALLING THE MACHINE ........................................................................ 12
UNPACKING ........................................................................................... 12
LOCATION.............................................................................................. 12
CONNECTIONS ....................................................................................... 13
ELECTRICAL SUPPLY ................................................................................ 13
PNEUMATIC SUPPLY ................................................................................ 13
USB AND ETHERNET PORTS ..................................................................... 13
MACHINE OVERVIEW ................................................................................. 14
MACHINE START UP ................................................................................ 14
USER CONTROLS .................................................................................... 14
MACHINE INTERFACE .............................................................................. 15
APPLICATION NAVIGATION ................................................................ 15
DIALOGS ......................................................................................... 17
CONTROL BAR .................................................................................. 18
SPLASH SCREEN ..................................................................................... 19
TEST SCREEN ......................................................................................... 21
TEST APPLICATION MENU .................................................................. 23
4.5.1.1 SELECT APPLICATION ..................................................................... 24
4.5.1.2 REPORTS ...................................................................................... 25
MACHINE OPERATION ................................................................................ 27
CREATING A NEW PRODUCT ..................................................................... 27
CREATE BLISTER MASK ..................................................................... 30

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PACK DETECTION ............................................................................. 32


LED SETUP ....................................................................................... 35
CREATING A NEW METHOD ...................................................................... 38
BATCH CONTROL .................................................................................... 42
CREATING A NEW BATCH ................................................................... 43
CHANGING BATCH ............................................................................ 44
REOPEN A CLOSED BATCH ................................................................. 44
CLOSING A CURRENT BATCH ............................................................. 45
RUNNING A TEST .................................................................................... 45
BARCODE SCANNING ........................................................................ 47
5.4.1.1 BATCH CONTROL ........................................................................... 48
5.4.1.2 BARCODE CLIPPING ....................................................................... 48
5.4.1.3 BARCODE READING BASED ON TOKEN ............................................. 49
5.4.1.4 BARCODE SCANNING PROCEDURE. .................................................. 49
SAVING A TEST REPORT .......................................................................... 50
SYSTEM BACKUP ..................................................................................... 50
AUTO BACKUP .................................................................................. 51
DATABASE BACKUP ........................................................................... 51
USER ACCOUNTS ........................................................................................ 52
USER GROUPS ........................................................................................ 52
CREATING A NEW USER GROUP.......................................................... 53
USER ACCOUNTS .................................................................................... 54
CREATING A NEW USER..................................................................... 55
SECURITY POLICY ................................................................................... 56
MACHINE CALIBRATION............................................................................. 58
CHAMBER SENSOR CALIBRATION ............................................................. 58
CHAMBER SENSOR VERIFICATION ...................................................... 60
LED BRIGHTNESS VERIFICATION .............................................................. 61
CAMERA FOCUS ...................................................................................... 62
LEAK TEST ............................................................................................. 63
CALIBRATION REPORT ............................................................................. 64
OPTIONS .................................................................................................... 65
GLOBAL OPTIONS ................................................................................... 65
LOCAL OPTIONS ..................................................................................... 69
MACHINE MAINTENANCE ........................................................................... 71
ROUTINE MAINTENANCE .......................................................................... 71

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DAILY CHECKS ................................................................................. 71


MONTHLY CHECKS ............................................................................ 71
6 MONTHLY CHECK ........................................................................... 71
YEARLY CHECK ................................................................................. 71
CRITICAL COMPONENTS .......................................................................... 71
MAINTENANCE CONTRACTS ..................................................................... 72
CLEANING .............................................................................................. 72
WORKSTATION ................................................................................. 72
SCREEN ........................................................................................... 72
ELECTRICAL COMPARTMENT .............................................................. 72
UPPER CASEWORK ............................................................................ 72
CAMERA AND LED COMPARTMENT ...................................................... 72
DISASTER RECOVERY .............................................................................. 74
ALARM LIST ............................................................................................ 82
APPENDIX 1. ELECTRICAL DRAWINGS ............................................................A
APPENDIX 2. PNEUMATIC DRAWINGS............................................................ D
APPENDIX 3. ASSEMBLY DRAWINGS ............................................................... F
APPENDIX 4. BILL OF MATERIALS .................................................................. H
APPENDIX 5. OEM DATA .................................................................................. I
APPENDIX 6. DECLARATION OF CONFORMITY ................................................ J
APPENDIX 7. SEPHA LTD WARRANTY DOCUMENT ........................................... L

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TECHNICAL SPECIFICATION

The VISIONSCAN is a quality product and as such carries a full guarantee against faulty
workmanship. The electrical and pneumatic components used in the manufacture of the
machine are available worldwide. Due to our policy of continuing development we reserve
the right to alter the design or function without prior notification.

Voltage: 24V DC
Power consumption: Approx. 60W
Air: 0.6MPa + 0.1MPa (6Bar + 1Bar) (87psi + 14.5psi)
Machine weight: 30kg (68kg including crate)
External dimensions: 440mm (L) x 470mm (W) x 520mm (H)
Model Numbers: T106-001-006
Software version: A106-020-001.2
Construction material: Top cover: Acrylic capped ABS
Machine frame: Anodised Aluminium
Display: 12.1” LCD touch screen
Operating system: Windows 10
Version 1703 (OS Build 15063.540) or later.
External interface: 2x USB 2.0 ports
1x Ethernet port
Operating temperature: 15 - 27°C.
Operating potential: 24 hours a day, 7 days a week
Humidity: <65% relative humidity
Noise level <75dB (from a height of 1m at 1m distance).
Manufacturing standards: BS EN 60204 Safety of machinery
Maximum pack size*: 170mm x 210mm maximum pocket depth 13mm
*Subject to testing.

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WARNING SYSTEM NOTICE

The following warning system notices are used in the document:

! WARNING
Indicates a potentially hazardous situation, which if not avoided may result in injury or
death.

! CAUTION
Indicates where a failure to observe an instruction or precaution could result in
equipment damage or undesirable operation.

 NOTE
Indicates where a failure to observe an instruction or precaution could result in
equipment damage or undesirable operation.

TYPOGRAPHICAL CONVENTIONS

The following conventions are used in this document:


Screen Title UPPERCASE
Dialog box text Bold
Button/Icon name Lowercase Italics

SAFETY

! WARNING
Failure to follow these instructions may cause harm to personnel and/or damage to
equipment.

• The equipment must be connected to a protective earth or grounded power supply.


• The equipment has been configured to operate only on the power source stated on
the machine ratings plate.
• Do not exceed the specified fuse ratings; to do so may cause damage to the
equipment.
• Do not exceed a maximum compressed air supply of 0.8MPa (8Bar)
• Only qualified personnel should service the equipment. Removing panels/fixed
guards may expose the user to dangerous voltages and/or moving parts.
• Do not open the electrical compartment without first disconnecting the power source.
• This manual should be read and understood in its entirety before installation and
operation of the VISIONSCAN.

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INTRODUCTION

OVERVIEW

VISIONSCAN is a tool-less, non-destructive inspection device for blister packs ideal for
selective in process inspection.

The VISIONSCAN uses a vision system to compare changes in blister pack lidding
material under vacuum to determine if leaks are present in the pockets. At the end of
the test cycle a pass/fail result will be displayed for all the pockets.

The packs will be loaded into the test area. The user will activate the test cycle. The
test cycle will be automatically executed according to a pre-defined test method. During
the cycle the blister packs will be subject to pressure and vacuum environments and
images taken of the change in characteristic of the lidding material. These images will
then be compared to determine if the blister pocket contains a leak. At the end of the
test cycle the user interface will display a pass/fail result for the blister that was tested.
A VISIONSCAN test chamber schematic and description is illustrated in Figure 1.

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3
4
5

NO. DESCRIPTION
1 Camera and lens
2 LED bar light
3 Vacuum/pressure chamber with viewing window
4 Pack retention system
5 Test area with blister pack

Figure 1 - VISIONSCAN test chamber schematic

OPERATING PRINCIPLE

The VISIONSCAN uses changes in the lidding foil shape under vacuum to detect good
pockets and those with a hole. It does this by comparing images taken by the camera
and using image analysis techniques to determine changes in the pocket surface.
Light is reflected onto each blister pack and an image acquired by the vision system
before and after a vacuum is applied to the test chamber. The deflection caused by the
difference between the pressure inside the pocket and the vacuum outside causes the
images to vary and this variation is analysed by the VISIONSCAN software to produce a
test result. The lidding foil of a good pocket will exhibit deflection that will be maintained
throughout the period of constant vacuum, while lidding foil with a substantial leak path
(pin hole size) will exhibit little or no deflection. In the case of micron order leak path the
lidding foil will initially deflect but then relax after a given test period. This can be

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detected by acquiring a third camera image and comparing it with the image taken at
initial vacuum. As well as using light intensity for comparison, it also looks at the light
profile of the pocket. A good pocket has a concave profile under vacuum and using
analysis techniques looking at light distribution the software can compare this concave
profile with the flat profile of the pocket before vacuum to give a change in centroid
position. If no change occurs the system displays a failed pocket result.

HIGH LEVEL DESCRIPTION

a) Standalone non-destructive leak tester, which includes; vision system, LED


lighting and IPC control system.
b) User interface via touch screen IPC.
c) The vision system and LED lights are used to analyse lidding foil on blisters packs
under vacuum.
d) A retention system will be used to hold the packs during test.
e) The instrument will be programmed and configured to test specific pack formats.
Each product will require a specific test method which will be developed through
the software and data entered via the touch screen display. Each product will
have an associated product folder which will contain the product data files.
f) When performing a test the user will initiate a test via a home/test screen
displayed on the touch screen display.
g) Results and audit trail data will be available to be exported via the touch screen
display.

FEATURES AND BENEFITS

The machine has the following features and benefits:


a) Non-destructive leak detection device designed for blister packs.
b) Tool-less. Ideal for production lines running multiple products.
c) Incorporates imaging technology that will detect defects in individual blister
pockets, channel leaks and weak seals in the magnitude of 15µm* using vacuum
lid deflection principle.
d) Test packs with printed coloured ink up to an area of up to 25%*.
e) Test pockets with protrusions (tablet under the lidding foil or indentations from
above) of maximum 1mm.
f) Test foils of aluminium or paper material*.
g) Rapid test for Gross defect or standard test for decay defect*.

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h) Operating system can store up to 30,000 product types.


i) Simple operator use via a touch screen interface.
j) Can test packs that contain tablets/capsules in multiple material/design formats*.
k) Objective, repeatable pack test for each product.
l) Capable of storing and exporting data for audit and quality control purposes.
m) Can form part of 21CFR part 11 compliant system.

 NOTE
*Dependant on blister size, material type, hole size, free volume of air and pocket
characteristics under vacuum.

LIMITATIONS

The VISIONSCAN operates by analysing movement in the lidding material under


vacuum. If there is no movement of the lidding material of a good pocket during the
vacuum process the VISIONSCAN is unable to detect any difference between a good
pocket and a pocket with a defect. This could be a results of the following blister pack
characteristics:
a) Mat black lidding material.
b) Multi coloured lidding material.
c) Pockets with a diameter smaller than 7mm.
d) Pre inflated pockets.
e) Blister pockets with no free volume of air/head space.

 NOTE
It is recommended that the customer contact SEPHA Ltd if they are considering leak
testing a blister pack with these characteristics.

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INSTALLING THE MACHINE

UNPACKING

The VISIONSCAN will be delivered in a crate and should be unpacked as follows:


a) Remove the fasteners from the top and front panel of the crate and the remove
the panels.
b) Using a mechanical lifting mechanism (forklift or pallet truck) remove from crate.
c) Remove any packaging material.
d) Move the VISIONSCAN to its desired location using the mechanical lifting
equipment.
e) Remove test area packaging material.

! WARNING
The VISIONSCAN weights in the order of 30kg. Loading and unloading of the machine
should only be carried out with appropriate mechanical handling equipment and
trained personnel.

LOCATION

The VISIONSCAN should be positioned on a level surface that is subject to minimal


vibration or movement. It is recommended that the machine should be positioned a
minimum of 25mm from another object and with free access to the machine power
switch.

! CAUTION
The machine power supply switch must be accessible in case of an emergency.

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CONNECTIONS

An overview of the machine connections is detailed in Figure 2.

Figure 2 - VISIONSCAN connections diagram


ELECTRICAL SUPPLY

Machine can be supplied by 100-240V ~ 50/60Hz 1.5A, provided the correct power lead
is attached to the power supply via plug.

PNEUMATIC SUPPLY

A compressed air supply should be connected to the air supply in (Figure 2) located on
the right hand side of the machine. The regulator will accept an 8mm OD pneumatic
pipe. The copressed air supply sould have the following specfication:
a) Minimum 0.6 MPa (6Bar) (87psi).
b) Minimum capacity of 200l/min.
c) Be clean, dry and free from oil.

! CAUTION
Compressed air supply should not exceed 0.8MPa (116psi).

USB AND ETHERNET PORTS

The VISIONSCAN has two USB 2.0 ports and one Ethernet port. The connections are
located on the right side of the machine (Figure 2).

 NOTE
The USB ports can be used to connect an external keyboard and mouse if desired by
the customer.
The Ethernet port can be used to connect the machine to the customer’s domain
network.

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MACHINE OVERVIEW

MACHINE START UP

To start up the VISIONSCAN ensure the machine is connected to the appropriate power
source (Section 3.4) and turn on machine via the power switch (location illustrated in
Figure 2). The machine will automatically power up and boot the application software.

USER CONTROLS

The VISIONSCAN is fitted with a LCD touchscreen display. All machine controls are
accessed through the application software from this display. The machine is not fitted
with a physical keyboard or mouse. All required data entry can be completed via the
software keyboard. If desired, the customer can attach an external keyboard for data
entry via the external USB ports

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MACHINE INTERFACE

APPLICATION NAVIGATION

Application navigation diagram is illustrated in Figure 3. This details the links between
each application.

HOME

MENU

SELECT APPLICATION

DEVELOPMENT CALIBRATION CONFIGURATION


TEST APPLICATION
APPLICATION APPLICATION APPLICATION

MENU MENU MENU MENU

Figure 3 - Application navigation diagram

TEST APPLICATION

TEST SCREEN REPORTS

Figure 4 - Test application navigation

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DEVELOPMENT
APPLICATION

TEST SCREEN REPORTS PRODUCT EDITOR

BLISTER DETECTION LIGHTS METHOD

Figure 5 - Development application navigation

CALIBRATION
APPLICATION

CHAMBER
REPORTS FOCUS LED LEAK TEST
SENSOR

Figure 6 - Calibration application navigation

CONFIGURATION
APPLICATION

OPTIONS SECURITY BACKUP ACCOUNTS GROUPS LOCAL OPTIONS

Figure 7 - Configuration application navigation

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DIALOGS

Figure 8 – Dialog

Table 1 - Dialog icons


ICON DIALOG
Information – Used to provide user with information that is not
critical to test performance.

Question – Used when input is required from user (i.e. yes/no).

Warning – Used to alert user when potential risk is present. List of


warnings in Section 11. Only one warning can be acknowledged at
a time.

Alarm (error) – Used when an event has aborted execution. List of


alarms in Section 11. Only one alarm can be acknowledged at a
time.

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CONTROL BAR

The application software has a permanent control bar which is displayed on each screen.
This provides the user quick access to certain functions. The control bar is illustrated in
Figure 9.

2 3 4 5 6 7 8 9 10

Figure 9 – Control bar description


Table 2 - CONTROL BAR description
NO. LABEL DESCRIPTION
1 Current machine status Current machine status;
Pass
Error
Fail
Action
Information
Request
2 Menu Go to MENU.
3 Start Start action on loaded plugin.
4 Save Save action on loaded plugin.
5 Add/left Add; method, product, batch, user.
6 Remove/delete/close/right Remove/delete/close; batch, user
7 Restore Restore to default settings on loaded plugin.

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NO. LABEL DESCRIPTION


8 Print Print report action. Check if USB connected;
YES - save to specified* path or USB. (* path set
in options)
NO - save to specified* path.
9 Advanced Displays advanced settings window if applicable.
10 Keyboard Open software keyboard. If pressed for longer than
400miliseconds, takes print screen of current
window and saves to a predefined location.

SPLASH SCREEN

On start up of the application software the SPLASH screen is displayed. The user can
select to log in with local or domain account credentials (assuming user account already
exists, if not a system administrator will need to create new credentials see Section 6.2).
Password entry will be hidden by asterisks as displayed in Figure 10. Active directory
users will be authenticated using .NET authentication.

Figure 10 - Splash screen

Splash screen action buttons are displayed in Table 3.

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Table 3 - Splash screen icon description


ICON NAME DESCRIPTION
Log in Display log in dialog.

Restart Restart machine.

Shutdown Shutdown machine.

Keyboard Touchscreen keyboard.

Reset Change password for selected local user. Change


password password dialog will appear prompting the user to enter
current password then new password (only displayed if
local is selected).
Local Log in using local credentials managed by application
software.

Domain Log in using domain credentials managed by customer IT


department.

Accept Proceed with selected credentials.

Cancel Cancel log in and return to SPLASH screen.

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TEST SCREEN

Successful log in from Figure 10 will navigate user to TEST screen Figure 11.

1
6

7
3

Figure 11 - Test screen

Table 4 - Test screen description


NO. DESCRIPTION
1 Press to select product. If no product selected machine status will display
PLEASE SELECT PRODUCT, status bar colour Cyan (Request action)
2 Pressing will display a dialog box for batch control. Following options available;
• Create new batch
• Select batch
• Re-open batch
• Close batch
• Cancel

3 Displays statistics dialog which will include total number of packs passed for the
current batch out of the total number of packs tested. (packs passed/total
packs tested)
4 Displays current session ID. ID will be auto generated.
5 Displays statistics dialog which will include total number of packs passed for the
current session ID out of the total number of packs tested for the same session.
(packs passed/total packs tested)

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NO. DESCRIPTION
6 Dynamic display. On entering the TEST screen or switching product, a stored
png image of currently selected product will be displayed to instruct operator on
correct pack placement inside test area. After completing a successful test, the
result image will be displayed. When the test is re-started, the previous test
images are discarded and will not have any impact on the new test results.
7 Live reading of vacuum chamber sensor on graduated scale from 300mbar to -
700mbar.

Test screen action buttons are displayed in Table 5.

Table 5 - Test screen icon description


ICON NAME DESCRIPTION
Menu Navigates to menu screen of the test application.

Start test Initiates test cycle. Button will only be active when all
cycle conditions are met to conduct a test cycle. If conditions
are not met icon will be greyed out.
Print .pdf Prints current batch test results to pdf/A.
report

Barcode scan Activates barcode scanning as configured in OPTIONS


Figure 43. Icon will be hidden if the feature is disabled.
Refer to section 0 for full details.
Stop test cycle Stops test cycle. Will store results if analysis has
already been calculated.

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TEST APPLICATION MENU

The test application has two plugins; TEST SCREEN and REPORTS as displayed in Figure
12. Pressing TEST SCREEN returns the user to Figure 11. On pressing REPORTS takes
the user to Figure 14.

Figure 12 - Test application menu

Table 6 – Test application menu icon description


ICON NAME DESCRIPTION
Log out Will log user out of current session and exit to SPLASH
screen Figure 10.

Reset to safety Machine will be set all hardware to idle position.

Select Displays list of applications, current application will be


application greyed out Figure 13.

Information Displays information of software versions of all plugins.

SOS Will open remote support application. This feature can be


disabled by editing batch file remote_support.bat.

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4.5.1.1 SELECT APPLICATION

Figure 13 – Select application menu

The APPLICATION MENU is described in Table 7.

Table 7 - Application menu description


TILE DESCRIPTION
Test application This is the default application executed on start-up. This
application is used for testing of blister packs and result are
generated. Functions available through this screen include change
product, print result and start/stop test cycle
Development This application is used to develop new or existing formats for
application test execution in the test application. Only released formats will
be available in the test application.
Calibration This application is used for calibrating; chamber sensor, LED
application lights and camera focus.
Configuration The about screen displays system information including machine
application model number, machine serial number and application software
version.

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4.5.1.2 REPORTS

User can select from a dropdown list of preconfigured report types;


• Audit
• Alarm
• Batch
• Calibration
• Method
• User

As the reporting system is controlled via SAP® Crystal Reports®, the reports are fully
configurable. Reports that are exported as pdf are pdf/a compliant.

Each report type will have a maximum of 2 executable functions; Print and/or Save. The
availability of these functions can also be preconfigured, with inactive functions being
greyed out.

Figure 14 - Test application reports screen

Table 8 – Test application reports screen icon description

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ICON NAME DESCRIPTION


Menu Navigates to menu screen of the test application.

Print report Opens crystal report in logicity viewer. User will then
be able to press print.

Save report Opens crystal report in logicity viewer. User will then
be able to press save.

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MACHINE OPERATION

CREATING A NEW PRODUCT

All the options required to develop a new product are accessed in the DEVELOPMENT
APPLICATION under the PRODUCT EDITOR screen. To create a new product, first the Add
icon must be pressed as described in Table 9

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Table 9

TEACH MACHINE LOCATION OF


CREATE BLISTER MASK
POCKET CAVITIES

TRAIN MACHINE TO LOCATE


PACK DETECTION
BLISTER PACKS

CAMERA EXPOSURE ADJUST CAMERA SETTINGS FOR


SETTINGS LIDDING MATERIAL ANALYSIS

SET RECIPE PARAMETERS TO


DEVELOP TEST METHOD
DETECT DEFECTS OF
PARAMETERS
PREDETERMINED LEVEL

CONDUCT VERIFICATION OF
RELEASE PRODUCT METHOD AND ENABLE PRODUCT
FOR TESTING IN TEST SCREEN

Figure 15 - Product development process

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Figure 16 - Product editor screen

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Table 9 – Development application product editor screen icon description


ICON NAME DESCRIPTION
Menu Navigates to menu screen of the development
application.

Save Saves changes to currently selected product.

Add Opens new product dialog.

Pressing New displays new product name input control.


When a valid name is entered, accept icon will become
active.

Pressing Import will open a new dialog, the user must


select the desired product to be imported (from a
location defined in LOCAL OPTIONS). Import will only
be visible if enabled in LOCAL OPTIONS.

Export Exports selected product to configurable location as


defined in LOCAL OPTIONS. Button will be inactive if
disabled in LOCAL OPTIONS.
Restore Will restore any changed parameters to previous
settings as when save was last pressed.

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CREATE BLISTER MASK

The process for creating a new blister mask is described in Figure 17, full information
provided with test method development training when purchased.

COLOUR IN THE POCKET AREAS WITH A BLACK PERMANENT MARKER, OR


PREPARE BLISTER PACK CUT OUT THE POCKET MATERIAL USING A SCALPEL AND THEN COLOUR
IN THE CAVITY WITH A BLACK PERMANENT MARKER.

REMOVE RETENTION
OPEN THE DRAWER AND REMOVE RETENTION FRAME
FRAME

PRESS BLISTER

PRESS START

SELECT SUITABLE
PARAMETERS SO ALL INFORMATION PROVIDED WITH TEST METHOD DEVELOPMENT TRAINING
POCKETS ARE DETECTED

PRESS ADD

PRESS SAVE

PRESS MENU

REPLACE RETENTION
OPEN THE DRAWER AND REPLACE RETENTION FRAME
FRAME

Figure 17 - Create blister mask flow diagram

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Figure 18 - Blister screen


Table 10 – Development application blister screen icon description
ICON NAME DESCRIPTION
Menu Navigates to menu screen of the development
application.

Start Initiates mask creation sequence by engaging


hardware.

Stop Stops mask creation sequence and resets hardware to


safety position.

Save Saves changes to currently selected product.

Add Will update blister mask results with any changed


parameters.

Restore Will restore any changed parameters to previous


settings as when save was last pressed.

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PACK DETECTION

Pack detection function sets up the parameters required for the vision system to
recognise the pack outline and correctly overlay the areas the vision system will analyse
for movement during the test cycle.

PLACE BLISTER PACKS IN PACKS SHOULD BE PLACED IN THE SAME ORIENTATION WITH MIMINAL TILT.
TEST AREA PACKS MUST NOT OVERLAP OR REST OUTSIDE THE TEST AREA

CLOSE DRAWER

PRESS DETECTION

PRESS START

WAIT FOR SEQUENCE TO


FINISH

PRESS SAVE

PRESS MENU

Figure 19 - Pack detection process

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1 8

2 9

4 10

5 11

Figure 20 - Detection screen during capture routine

Table 11 – Development application detection screen description


NO. DESCRIPTION
1 Select detection method from drop down menu;
• Short – quick sequence with most common parameters.
• Long – full sequence with entire range of parameters.

2 Select number of packs placed inside chamber.


3 Acceptable criteria required for successful pack detection. This value should
be left at 700.*
4 Factor by which each pixel is expanded.*
5 Allowable % error in pack recognition.*
6 Select LEDs used to illuminate test area; LR, TB, ALL.
7 Dynamic button (ON/OFF). If enabled, a template override image is created.
This image is used during testing to override pack detection and execute
testing with the blisters in a fixed position. This feature should only be
activated when a product nest insert is used. Default OFF.
8 The detection result is scored from 0 -1000, with 1000 being the best
possible result.
9 Amount of % error in pack recognition.
10 Camera gain used for detection.
11 Camera shutter used for detection.
* Full information provided with test method development training when purchased.

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Table 12 – Development application detection screen icon description


ICON NAME DESCRIPTION
Menu Navigates to menu screen of the development
application.

Start Initiates detection sequence by engaging hardware.

Stop Stops detection sequence and resets hardware to


safety position.

Save Saves changes to currently selected product.

Restore Will restore any changed parameters to previous


settings as when save was last pressed.

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LED SETUP

The processed images are analysed (utilising camera gain and shutter) to determine
optimal settings so that the lidding foil is adequately illuminated during test sequence
analysis. This function can be customised if required to suit different pack formats
including light orientation and light order.

PLACE BLISTER PACKS IN PACKS SHOULD BE PLACED IN THE SAME ORIENTATION WITH MIMINAL TILT.
TEST AREA PACKS MUST NOT OVERLAP OR REST OUTSIDE THE TEST AREA

PRESS LIGHTS

PRESS START

SELECT SUITABLE
PARAMETERS SO ALL INFORMATION PROVIDED WITH TEST METHOD DEVELOPMENT TRAINING
POCKETS ARE EXPOSED

PRESS ADD

PRESS SAVE

PRESS MENU

Figure 21 - LED setup process

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2 6

Figure 22 - Lights screen

Table 13 – Development application light screen description


NO. DESCRIPTION
1 Select light order from drop down menu.
2 Adjustable shutter value from 0-100%.
3 Adjustable gain value from 0-100%.
4 Configurable lower pocket value limit.
5 Configurable higher pocket value limit.
6 Displays gain and shutter values stored for each light order.

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Table 14 - Camera setup icon description


ICON NAME DESCRIPTION
Menu Navigates to menu screen of the development
application.

Start Initiates lights sequence by engaging hardware.

Stop Stops lights sequence and resets hardware to safety


position.

Save Saves changes to currently selected product.

Add Will update image results with any changed


parameters.

Restore Will restore any changed parameters to previous


settings as when save was last pressed.

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CREATING A NEW METHOD

Each product installed on the VISIONSCAN will have an associated test method. The
test method will contain all the parameters required to determine if the tested pack are
assigned a pass or a fail result. Smart test mode will only execute a new test cycle if any
physical parameters have changed since the last time Play was pressed.

Figure 23 - Method screen


Table 15 - Method icon description
ICON NAME DESCRIPTION
Menu Navigates to menu screen of the development
application.

Start Initiates method sequence by engaging hardware.

Stop Stops lights sequence and resets hardware to safety


position.

Save Saves changes to currently selected product.

Advanced Opens the settings window of the METHOD screen


Figure 24.

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Figure 24 – Development application method screen settings window

Table 16 - Development application method screen settings window description


ITEM DESCRIPTION
DECAY PARAMETERS
Decay Vacuum level produced in vacuum chamber (0-700) from which
decay image is acquired.
Collapsing Time Time delay before introducing reduced vacuum and taking image.
(0-999).
Reduced Vacuum level used to produce product collapse for small holes (0-
700).
Limit The percentage of black to white displayed for each pocket in the
decay comparison image under which the VISIONSCAN identifies
the pocket as having a decay leak.
Threshold 1 The grayscale change required per pixel before the VISIONSCAN
identifies a change between the Decay and Reduced image. If
above the threshold value the pixel is shown in white in the
comparison image. (0-255). Setting for analysis 1 light
orientation.

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ITEM DESCRIPTION
Threshold 2 The grayscale change required per pixel before the VISIONSCAN
identifies a change between the Decay and Reduced image. If
above the threshold value the pixel is shown in white in the
comparison image. (0-255). Setting for analysis 3 light
orientation.
AutoM Turn on/off AutoM filter.
Erode Turn on/off Erode filter.
Erode 1 Number of iterations.
Dilate Turn on/off Dilate filter.
Dilate 1 Number of iterations.
GROSS PARAMETERS
Reference Pressure developed in vacuum chamber (0-300) before reference
image is captured.
Gross Vacuum level produced in vacuum chamber (0-700) from which
gross Vacuum 1 image is acquired.
Limit The percentage of black to white displayed for each pocket in the
gross comparison image over which the VISIONSCAN identifies
the pocket as having a gross leak.
Threshold 1 The grayscale change required per pixel before the VISIONSCAN
identifies a change between the Reference and Gross image. If
above the threshold value the pixel is shown in white in the
comparison image. (0-255). Setting for analysis 1 light
orientation.
Threshold 2 The grayscale change required per pixel before the VISIONSCAN
identifies a change between the Reference and Gross image. If
above the threshold value the pixel is shown in white in the
comparison image. (0-255). Setting for analysis 2 light
orientation.
AutoM Turn on/off AutoM filter.
Erode Turn on/off Erode filter.
Erode 1 Number of iterations.
Dilate Turn on/off Dilate filter.
Dilate 1 Number of iterations.
Centroid Activates the function of centroid.

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ITEM DESCRIPTION
Centroid limit The number of pixel change threshold between reference image
centroid and vacuum image centroid before pocket is indicated as
a pass for gross leak.
LIGHT ORDER
Analysis 1 Light order in which LEDs are activated during image caption.
Analysis 2

 NOTE
Full method development training can be provided by SEPHA LTD.

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BATCH CONTROL

The TEST screen (Figure 25) has the ability to create a new batch, close a current batch
and reopen a closed batch (Figure 26). This can be initiated by pressing the batch
header as indicated below by the area highlighted in the blue rectangle.

Figure 25 – Batch header

Figure 26 - Batch control

Batch control icon functions are detailed in Table 17

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Table 17 – Batch control icons description


ICON NAME DESCRIPTION
New batch Create new batch.

Change Batch Select a previously opened but not closed batch.

Reopen batch Reopen a closed batch (only visible if activated in


OPTIONS).

Close Batch Close the current batch.

Cancel Exit batch control dialog to TEST SCREEN.

CREATING A NEW BATCH

To create a new batch, ensure the product you want to create the new batch for is
selected from the drop down menu (Figure 25). Press the batch header to display the
batch control dialog (Figure 26) and press New batch icon ( Table 17 ) and enter the new
batch name into the dialog box (Figure 27).

Figure 27 – Create new batch dialog

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If the batch name already exists the user will be prompted and the tick button will not be
active. Once a valid batch name has been entered press the tick button to accept and
the new batch will be created.

 NOTE
Windows invalid characters cannot be used in the creation of a new batch name. For
example the ‘/’ character.

CHANGING BATCH

To change the batch for one that is already open, press the change batch icon. A dialog
as displayed in Figure 28 will be presented. Any batches that are currently opened but
not closed will be displayed in a dropdown list for selection. Press the tick to accept or
the cross to exit.

Figure 28 - Change batch dialog

REOPEN A CLOSED BATCH

To reopen a closed batch press the reopen batch icon ( Table 17

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Table 17) and select the batch name from the dropdown menu (Figure 29) that is to be
reopened. Press the tick to accept or the cross to exit. This feature will only be visible if
activated in OPTIONS.

Figure 29 - Reopen batch dialog

CLOSING A CURRENT BATCH

To close the current batch, ensure the batch you want to close is populated in the batch
field (Figure 25) and press the close batch icon. A confirmation dialog (Figure 30) will
pop up with the batch ID that will be closed. Press the tick to accept or the cross to exit.

Figure 30 - Close batch confirmation dialog

Actions can be executed after batch completion (closing batch), such as automatic
machine backup or print batch report. This can be configured using a batch file
“close_batch.bat”.

To set automatic backup after close batch, navigate to file explorer then complete the
following steps:
a) If not already present, create “close_batch.bat”
b) Right click, edit
c) Enter the following
"C:\Program Files (x86)\Pranas.NET\SqlBackupFree\SqlBackupFree.exe" -r "D:\Backup\new.jobx" -diff
"C:\Program Files (x86)\Uranium Backup\Uranium.exe" cmdline execbks "Mini Backup" T V T.

d) Save .bat file and exit.

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RUNNING A TEST

To run a test, navigate to the TEST screen and complete the following steps:
a) Logon to machine (Section 4.4).

Select product – press the product ( Figure 11

b) Figure 11, Table 4) and ensure that the correct product is selected from the
dropdown menu .

c) Create a new batch if required (Section 5.3.1).


d) Return to the TEST screen and press the start test icon.

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e) The machine will execute the test cycle and results will be displayed on screen at
the end of the test cycle.
f) Test results can be exported from the TEST screen by pressing the print report
icon or navigating to REPORTS screen and following instructions in Section
4.5.1.2.

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BARCODE SCANNING

Barcode scanning will be used to select the Product and Batch data required for testing.
For example, when an operator wishes to test a product they will use the barcode
scanner to select product and batch from a pre-defined barcode list. The operator will
then load the packs and start test. All results data will reference the information from
the barcode.
The machine software will be configured to use the following scanner type.
Scanner type: USB

Barcode type: Code 128

Character set: ASCII

Scanned data will be generated from a list of pre-defined barcodes for example, product
name and batch name. There will be 3 options for data input;
Option 1: Single scan product name

Option 2: Double scan product name and batch name

Option 1 scan mode (Table 18) will require a single product barcode scan. Option 2 scan
mode ( Table 19

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Table 19) will require a product and batch barcode scan. The scanning mode will be set
in the OPTIONS plugin. For the scanner to recognise a product, the barcode that is
scanned must match the product names that are installed on the machine.

Table 18 - Barcode scan option 1 (product)

Scan Name Barcode example Description


Product Scan consists of a single
product name in one barcode.

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Table 19 – Barcode scan option 2 (Product and batch)


Scan Name Barcode Description
Product Scan 1 product name.

Batch Scan 2 consists of batch name.


This will either select a current
batch or open a new batch.

5.4.1.1 BATCH CONTROL

When scanning the batch barcode the machine will recognise if the code is a ‘new batch’
or existing batch. If it’s a new code the machine will create a new batch name. If the
batch already exists the machine will reopen the existing batch. Reopening an existing
batch can be disabled in the CONFIGURATION application.

5.4.1.2 BARCODE CLIPPING

The software has the ability to ‘clip’ the barcode and only look at certain portions. For
example if only the digits ‘655’ were required from the bar code illustrated below. The
software will ignore four digits from the left and three digits from the right of the code
giving you ‘665’. This can be set in the options editor.

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5.4.1.3 BARCODE READING BASED ON TOKEN

The software has the ability to read sections of the barcode based on a ‘token’ to
separate sections of the code. For example if only the information TEST PRODUCT was
required from the barcode illustrated below, the token is the ‘;’ character and the
position of TEST PRODUCT is ‘0’. This will allow the software to ignore the information
‘TEST’ from the code. If the information TEST was required and not TEST PRODUCT then
the token position would be 1.

5.4.1.4 BARCODE SCANNING PROCEDURE.

When barcode scanning is enabled in the machine OPTIONS plugin, a barcode button is
visible on the control bar of the test screen.

Once the scan button is pressed from the Test Screen the scanning process will begin.
The operator will then scan the appropriate bar codes when prompted as displayed
Figure 31.

Figure 31 - Barcode scanning procedure

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SAVING A TEST REPORT

Figure 32 - Reports screen

Files screen icon description detailed in Table 8.

To save a test report into a human readable format, navigate to REPORTS screen in any
application menu except for configuration application and then complete the following
steps:
a) Select the report type from the dropdown menu.
b) Press the print report icon to open selected report.
c) If prompted, select product and desired batch/batches (only required if select
batch is selected, all other reports are auto compiled).
d) The report can now be saved, printed or closed via the toolbar depending on
report type.

SYSTEM BACKUP

It is strongly recommended that the VISIONSCAN is backed up regularly to avoid any


loss of information. This can be done by a number of ways.

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AUTO BACKUP

The VISIONSCAN by default is set to periodically take incremental backups which are
exported to a USB drive situated in the USB hub inside the casework of the machine.
This backup can be used when a PC failure has occurred, however if the entire machine
becomes compromised (i.e. total disaster) the backup will also be destroyed. For this
reason, it is recommended that the backup should be stored externally from the
machine. In CONFIGURATION APPLICATION both backup types can be configured using
File backup and SQL backup, where the destination location of the backups can be
specified as per customer SOP.

DATABASE BACKUP

If the VISIONSCAN database is located on an external server connected via domain, the
database will be backed up via customer IT department as part of server backup
procedures.

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USER ACCOUNTS

USER GROUPS

1 3

4
2

Figure 33 - Groups screen


Groups screen description detailed in Table 20.

Table 20 - Groups screen description


NO. DESCRIPTION
1 Select group - Select existing group from dropdown menu to view privilege
settings for that group.
2 Privileges – Select privileges so assign to the user group selected from the
dropdown menu. A dynamic button (ON/OFF) beside the action or screen
denotes privileges allowed. By default, all privileges for administrator group
will be on and cannot be turned off.
3 Dynamic button (ACTIVE/DEACTIVATED) for status of selected group. If an
active group containing users is deactivated, a dialog warning that all
associated users for the selected group will be removed. The dialog can be
accepted or cancelled. By default, the administrator group will be active and
cannot be deactivated.
4 Displays all associated users of selected group.
5 Action buttons as detailed in
Table 21.

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Table 21 - Group screen action icons description

ICON NAME DESCRIPTION


Menu Navigates to menu screen of the configuration
application.

Save Saves changes to currently selected group.

Add group Will create new user group. When a valid name is
entered, accept icon will become active.

Restore Will restore any changed parameters to previous


settings as when save was last pressed.

CREATING A NEW USER GROUP

To create a new user group navigate to CONFIGURATION APPLICATION MENU, GROUPS


and then complete the following steps.
a) Press the add group icon.
b) Enter the new group name into the dialog box and press the tick icon to accept or
the cross icon to cancel.
c) The new group will appear in the dropdown menu (Figure 33).
d) Assign privileges to the new group by selecting the dynamic button beside the
privilege that is to be assigned to the group.
e) Press the save icon to save the assigned privileges to the selected group.

 NOTE
The save icon must be pressed before leaving the groups screen or changes will not be
saved.

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USER ACCOUNTS

Figure 34 - Accounts screen

Accounts screen description detailed in Table 22.

Table 22 - Accounts screen description


NO. DESCRIPTION
1 Select user - select existing user from the dropdown to see what group user
has been assigned to.
2 Assigned group – select existing group to assign user. This will assign the
groups privileges to the user selected in point 1.
3 Displays status of selected user.
4 Status buttons;
• Retire – Press to deactivate user and remove from logon screen
selection.
• Lock – Press to lock user. User will be displayed in logon screen but
will be greyed out.
• Reset – Press to reset user. This will re-activate user after either
retire or reset have been pressed. This can also be used to reset
selected users password to a temporary password.
5 Action buttons as detailed in Table 23.

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Table 23 - Accounts screen icons description


ICON NAME DESCRIPTION
Menu Navigates to menu screen of the configuration
application.

Save Saves changes to currently selected user account.

Add user Will create new user account. When a valid name is
entered, accept icon will become active.

Restore Will restore any changed parameters to previous


settings as when save was last pressed.

CREATING A NEW USER

To create a new user navigate to CONFIGURATION APPLICATION MENU, ACCOUNTS


screen and then complete the following steps.
a) Press the add user icon.
b) Enter the new user name into the dialog box and press the tick icon to accept or
the cross icon to cancel.
c) The new user name will appear in the drop down menu (Figure 34).
d) Assign the user an existing user group to determine the privileges for that user.
If a new user group is required refer to Section 6.1.1.
e) Press the save icon to save changes.

 NOTE
If a user name is retired that user name cannot be used again.
The save icon must be pressed before leaving the ACCOUNTS screen or changes will
not be saved.

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SECURITY POLICY

The SECURITY screen sets the password and account definitions on the VISIONSCAN. If
the change in security policy affects currents users, they will be forced to change their
password on next login. SECURITY screen is displayed in Figure 35, and the security
policy described in Table 24.

Figure 35 - Security screen

Security screen description detailed in Table 24.

Table 24 - Security screen description


ITEM DESCRIPTION
Minimum user Sets the minimum user name length.
name length
Password length Sets the minimum password length.
Minimum service Sets the minimum password length of the service user.
user password
length
Maximum number Max number of incorrect password entries before the user is
of retries disabled.
Enforce password The number of password changes that are required before the
history user can revert to the first password again.

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ITEM DESCRIPTION
Maximum Forced password change after the set number of days.
password age
Domain prefix Domain prefix for active directory connectivity
Set password Dynamic button (ON/OFF). When turned on, the password
strength complex structure field displays all parameters required for successful
creation. When turned off, the password structure field displays
the only requirement – minimum password length.

 NOTE
The save icon must be pressed before leaving the security screen or changes will not
be saved.

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MACHINE CALIBRATION

The VISIONSCAN requires calibration every 12 months or after a machine service. The
calibration of the VISIONSCAN consists of three elements:
a) Pressure sensor / vacuum regulator
b) LED Brightness
c) Camera focus
Once calibration has expired on any one of the three elements the machine will not run a
test cycle.

! CAUTION
Carrying out a calibration will modify instrument settings. This will affect all
subsequent results. Calibration is to be carried out by trained personnel only.

CHAMBER SENSOR CALIBRATION

Figure 36 - Chamber sensor calibration

Chamber sensor calibration screen description detailed in Table 25.

Table 25 - Chamber sensor calibration screen description


NO. DESCRIPTION
1 Number of days remaining before calibration expires.

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NO. DESCRIPTION
2 Value number is the engineering unit from the sensor under calibration. The
mbar value is what the sensor is currently reading and is based on the last
saved calibration file.
3 Actions buttons including start and save icons.

To begin chamber sensor calibration, navigate to CALIBRATION APPLICATION MENU,


CHAMBER SENSOR and then complete the following steps:
a) Open drawer.
b) Attach external pressure/vacuum source and external pressure meter to
calibration test port on the right hand side of the machine beside mains air
supply.
c) Press start button.
d) Apply target pressure/vacuum displayed on message dialog with external
pressure/vacuum source.
e) Once target pressure/vacuum matches external pressure/vacuum press the tick
icon which will accept the value.
f) A new target pressure/vacuum will be displayed on message dialog.
g) Once all values have been calibrated, a message dialog will appear and ask if
calibration should be saved or not.
h) Remove the vacuum calibration equipment from calibration test port and close
drawer.
i) Press tick icon and follow on screen instructions. The machine will automatically
calibrate vacuum regulator without user input.
j) Once completed, accept/save calibration.

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CHAMBER SENSOR VERIFICATION

Prior to executing calibration, a verification can be performed to ensure the calibration


hasn’t drifted since last calibration. The verification will not be recorded by the system in
the audit as no information is generated, this is a visual confirmation using an external
pressure/vacuum source and external vacuum meter. The verification can be manually
recorded for archiving using a table as illustrated in Table 26.

To begin chamber sensor verification, navigate to CALIBRATION APPLICATION MENU,


CHAMBER SENSOR and then complete the following steps:
e) Open drawer.
f) Attach external pressure/vacuum source and external pressure meter to
calibration test port on the right hand side of the machine beside mains air
supply.
g) Apply various target pressure/vacuum levels with external pressure/vacuum
source. Compare readings from vacuum meter to that displayed on the HMI of
the machine. An example of a calibration verification table shown in Table 26 can
be completed to record comparison and detail any deviation if any.
h) Remove the vacuum calibration equipment from calibration test port and close
drawer.

Vacuum meter Displayed Value Difference Tolerance Within


set point (mbar) (mbar) (+/- mbar) tolerance
(mbar) (Pass/Fail)

+300

-700

Table 26 - Calibration verification

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LED BRIGHTNESS VERIFICATION

Figure 37 - LED brightness calibration

LED screen description detailed in Table 27.

Table 27 - LED screen description


NO. DESCRIPTION
1 Displays selected LED (1 through 4)
2 Number of days remaining before calibration expires.
3 Brightness distribution graph, live reading of the brightness distribution
(black line). Orange line denotes brightness distribution target.
4 Live chamber image. The green line on the image is the area measured.
5 Brightness distribution values, mean brightness and standard deviation
values measured from eight segments of the graph. Once values are within
range the save icon will become active.
6 Action buttons including start, save, previous LED and next LED.

To begin brightness calibration navigate to CALIBRATION APPLICATION MENU, LED and


then complete the following steps:
a) Open drawer and rotate black anodised aluminium insert.
b) Remove retention frame.
c) Load brightness calibration plate into recess of black anodised insert with the grey
side facing upwards.

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d) Close drawer and press start icon.


e) Select LED to calibrate; LED 1,2,3,4.
f) Once calibration values are within range the save icon is active and the values
can be saved for the selected LED
g) This process is then repeated for the rest of the LEDs.
h) Once all LEDs have been calibrated, the calibration period will be updated to
display the number of days until next calibration.

CAMERA FOCUS

Figure 38 - Camera focus

Camera focus calibration screen description is detailed in Table 28.

Table 28 - Camera focus calibration screen description.


NO. DESCRIPTION
1 Number of days remaining before calibration expires.
2 Live view of optical character recognition (OCR) plate.
3 Action buttons including start and save.

To begin focus calibration navigate to CALIBRATION APPLICATION MENU, FOCUS and


then complete the following steps:
a) Open drawer and rotate black anodised aluminium insert.
b) Remove retention frame.

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c) Load brightness calibration plate into recess of black anodised insert with the grey
side facing upwards.
d) Close drawer and press start icon.
e) Once all characters are correctly recognised, the save icon will become active.
Press the save icon and the sequence will finish.

LEAK TEST

The seal integrity of the test chamber can be tested by raising the nest and injecting
pressure to ensure air does not leak out. Navigate to LEAK TEST plugin and press Start.
At the end of the test either pass or fail will be displayed.

 NOTE
If a fail result is generated, ensure nest is located correctly and repeat test. Failure
indicates that the chamber seal is not located correctly, damaged or worn.

Figure 39 - Leak test plugin

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CALIBRATION REPORT

The report includes time/date stamps including the operator name of who conducted the
calibration (Figure 40).

Figure 40 - Calibration report example

To save a test report into a human readable format, navigate to REPORTS screen in any
application menu except for configuration application and then complete the following
steps:
a) Select the calibration from the dropdown menu.
b) Press the save report icon to open calibration report.
c) The report can now be saved, printed or closed via the toolbar.

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OPTIONS

The options for VISIONSCAN are separated into 2 categories. Global options are located
in OPTIONS screen and local options are located in LOCAL OPTIONS screen in the
CONFIGURATION APPLICATION.

GLOBAL OPTIONS

Options which will be active for all machines connected to the same global database
(only if database is located on customer domain).

Figure 41 - Global options screen 1 of 3


Global options screen description detailed in Table 29.

Table 29 - Global options screen description 1 of 3


ITEM DESCRIPTION
Reason for change Dynamic button (ON/OFF). If enabled, any parameter which will
mandatory affect the integrity of the test cycle will require user to log reason
why the change was performed. Default OFF.
Product Dynamic button (ON/OFF). If enabled, a description of the
description product must be entered at creation before it can be saved.
mandatory Default OFF.
Batch description Dynamic button (ON/OFF). If enabled, a description of the batch
mandatory must be entered at creation before it can be saved. Default OFF.

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ITEM DESCRIPTION
Non conformance Dynamic button (ON/OFF). If enabled, any result that fails a test
flag cycle will display a message informing the user that a failure was
detected. Default OFF.
Re-open batch Dynamic button (ON/OFF). If enabled it will display the Reopen
batch icon in Figure 26.
Auto logoff time Sets the time in minutes when a user will be automatically logged
off the machine if no actions has been taken. Default 10 mins.
Global folder Sets the location of the central database if stored on customer
domain. Default blank.

Table 30 - Global options screen icon description


ICON NAME DESCRIPTION
Menu Navigates to menu screen of the configuration
application.

Save Saves changes to currently selected options screen.

Next screen Navigates between GLOBAL OPTIONS screen 1, 2 and


3.

Restore Will restore any changed parameters to previous


settings as when save was last pressed.

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Figure 42 - Global options screen 2 of 3


Global options screen description detailed in Table 31.

Table 31 - Global options screen description 2 of 3


ITEM DESCRIPTION
Service mandatory Dynamic button (ON/OFF). If enabled, the test cycle will be
disabled if service has expired. Default OFF.
Service expiry Will display a reminder a set number of test cycles before service
reminder is due to expire. Default 10000 test cycles.
Calibration Dynamic button (ON/OFF). If enabled, the test cycle will be
mandatory disabled if calibration has expired. Default OFF.
Calibration expiry Will display a reminder a set number of days before calibration is
reminder due to expire. Default 10 days.
Calibration period Sets number of days calibration is valid for. Default 365 days.

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Figure 43 - Global options screen 3 of 3


Table 32 - Global options screen description 3 of 3
ITEM DESCRIPTION
Barcode scan Dynamic button (ON/OFF). If enabled, the Barcode icon will be
visible in TEST screen. Default OFF.
Barcode scan type Dropdown selection of barcode scan types. “Double scan product
and batch name” will require both product and batch to be
entered via barcode with 2 separate scans. “Single scan product
name” will require only one scan containing the product name.
Barcode scan time The amount of time allowed for each scan to occur.
Product type Selects barcode reading method for product name entry.
Product token Specifies token character.
Product token Specifies token position in barcode as explained in section 5.4.1.3
position
Product left Specifies how many characters from left side of barcode to ignore
clipping as explained in section 5.4.1.2.
Product right Specifies how many characters from right side of barcode to
clipping ignore as explained in section 5.4.1.2.
Batch type Selects barcode reading method for batch name entry.
Batch token Specifies token character.
Batch token Specifies token position in barcode as explained in section 5.4.1.3
position

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ITEM DESCRIPTION
Batch left clipping Specifies how many characters from left side of barcode to ignore
as explained in section 5.4.1.2.
Batch right Specifies how many characters from right side of barcode to
clipping ignore as explained in section 5.4.1.2.

LOCAL OPTIONS

Options which will only be active for the local machine.

Figure 44 - Local options screen


Global options screen description detailed in Table 33.

Table 33 - Local options screen description


ITEM DESCRIPTION
Language Dropdown selection of pre-installed languages. Default English.
Start application Dynamic button (TEST-BASIC/DEVELOPMENT). Selects which
application will be loaded on startup. By default the TEST
APPLICATION will be selected.
Machine nick The machine will have a unique serial number. A specific name
name can also be assigned to the machine using this text entry field.
Default blank.

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ITEM DESCRIPTION
Machine The machine will have a unique serial number. A specific location
Localisation can also be assigned to the machine using this text entry field.
Default blank.
Product import Dynamic button (ON/OFF). If enabled, Import icon will be
displayed in Table 9. If disabled the icon will be hidden.
Product import Defines the location where products will be imported from. If left
source blank the machine will automatically look for an attached USB
pen drive.
Product export Dynamic button (ON/OFF). If enabled, Export icon will be
displayed in Figure 16. If disabled the icon will be hidden.
Product export Defines the location where products will be exported to. If left
destination blank the machine will automatically look for an attached USB
pen drive.

Table 34 - local options screen icon description


ICON NAME DESCRIPTION
Menu Navigates to menu screen of the configuration
application.

Save Saves changes to currently selected options screen.

Restore Will restore any changed parameters to previous


settings as when save was last pressed.

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MACHINE MAINTENANCE

ROUTINE MAINTENANCE

DAILY CHECKS

a. Visual check product mat is clean, have no debris and are adhered to nest.
b. Visual check no blister packs have fallen out of nest.

MONTHLY CHECKS

a. Visual check the test chamber seal to ensure there is no damage or wear that
could inhibit the performance of the vacuum or pressure integrity.
b. Visual check retention frame wire is not broken.

6 MONTHLY CHECK

a. Remove upper casework and visual check vacuum chamber window for dust. If
there is dust present use a low pressure airline or anti-static cloth to remove
dust.

! WARNING
Do not alter or move the position of the LEDs or camera. These positions are set by
SEPHA and are critical to machine operation.
! WARNING
Do not remove fixed guards unless machine has completely shut down and the
pneumatic supply disconnected.

YEARLY CHECK

a. Machine calibration required. This will include chamber sensor, Brightness and
focus. Refer to SECTION 7.
b. Remove upper casework, vacuum any dust debris. Check electrical connections
are secure.
c. Machine service by Sepha Engineer recommended

CRITICAL COMPONENTS

The VISIONSCAN has components that are deemed critical to the machine operation. A
list of recommended Operational and Strategic Spares can be found in APPENDIX 5.

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MAINTENANCE CONTRACTS

Customers are advised to enter into a routine maintenance contract with Sepha. It is
recommended that the machine is serviced by a Sepha Engineer every 100,000
operation cycles or annually, whichever comes sooner.

 NOTE
If you have any questions regarding maintenance contact SEPHA LTD

Tel: + 44 (0) 2890 484848


Email: engineering@sepha.com

CLEANING

WORKSTATION

The anodised aluminium workstation can be washed in warm detergent solution (diluted
isopropanol) and should be dried thoroughly before use. The interior may be cleaned
with a vacuum cleaner. Dust that gathers on the machine can be removed with a
microfiber/anti-static cloth.

SCREEN

Anti-static wet/dry screen wipes suitable for use with LCD TFT monitors should be used.

ELECTRICAL COMPARTMENT

This area should be wiped with a microfiber/anti-static cloth or a vacuum cleaner.

! WARNING
Power down machine and turn off pneumatic supply before cleaning this area. Risk of
electric shock.

UPPER CASEWORK

Plastic/Acrylic Cleaner/Polish and soft non-abrasive cloth, do not wipe over VISIONSCAN
decal as it will discolour. The decal can withstand mild detergent mixed with water.

CAMERA AND LED COMPARTMENT

This area should be cleaned with a low pressure air line or microfiber/anti-static cloth.
Camera lens should be cleaned with extreme care. Do not use abrasive cloth or wipes. It
is recommended that the camera lens is only cleaned by Sepha personnel during
servicing.

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! WARNING
Do not adjust the camera lens aperture or focus ring. These positions are set by
SEPHA and are critical to machine operation.

! WARNING
Do not alter or move the position of the LEDs or camera. These positions are set by
SEPHA and are critical to machine operation.

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DISASTER RECOVERY

If computer failure occurs, the process to restore the machine is as follows;


1. Disconnect the machine from power and pneumatic supply.
2. Remove top casing from machine by removing the 2 screws under the rear of the
machine. Then undo the 2 clips on the inside of the front of the machine. Slide
the casing off the machine by lifting it straight up.
3. Locate the computer at the very top of the machine.
4. Remove all cables from the computer.
5. Slide the computer to the right and lift to detach it from the machine.
6. Return the defective computer to Sepha Ltd.
7. Install the replacement computer into machine. Installation is reverse of removal.
8. Reattach the top casing to the machine. Slide the case down, taking care that the
fixing blocks to the rear do not clash with internal assembly, bend case away
from top plate gently if necessary. Push down until front clips click into place and
lower casing is flush with upper casing.
9. Reinstall screws at rear.
10. Connect machine to power and air supply.
11. Power on machine.
12. Locate the latest SQL backup file. This will be in a .zip file, default location in
E:\Backup

13. Extract the .bak file from the .zip file

14. Right click on the extracted .bak file and select Properties

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15. Go to the Security tab

16. Select Edit

17. Select Add

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18. In the input field type users

19. Select Check Names

20. Select OK

21. Select Users then tick Full Control

22. Select Apply then OK then OK on the properties window

23. Double click the .bak file

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24. SQL Restore will open and auto-populate the relevant information

a. If the information is not auto-populated, select Change

b. For Server Name, enter (local)\SQLEXPRESS

c. Select Use SQL Server Authentication

d. Enter the SQL server administrator username and password

e. Select Test SQL Connection to verify the details are correct

25. Select Restore

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26. Select Yes on the pop up window

27. SQL Restore will confirm the restore was successful

28. Start the File Backup application.


29. Close the VisionScan software.
30. In Uranium Backup select Restore.
31. Select Restore from a files and folders incremental or differential backup.

32. Select Add from Disk from the plus icon in the top right.

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33. Navigate to E:\Backup\VisionScan.


34. Open _UraniumBackup.dat.

35. Repeat for _UraniumBackup.dat in locations E:\Backup\Global and


E:\Backup\Local.
36. Under the E:\Backup\VisionScan path select the backup to be restored.

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37. Select Next.

38. Tick the backup file in the main window.


39. In the Select restore folder input box insert C:\Program Files
(x86)\TASITEST\VisionScan.

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40. Select Restore.


41. Select Back.
42. Under the E:\Backup\Local path select the backup to be restored.
43. Select Next.
44. Tick the backup file in the main window.
45. In the Select restore folder input box insert C:\ProgramData\TASITEST\Local.
46. Select Restore.
47. Select Back.
48. Under the E:\Backup\Global path select the backup to be restored.
49. Select Next.
50. Tick the backup file in the main window.
51. In the Select restore folder input box insert C:\ProgramData\TASITEST\Global.
52. Select Restore.
53. Close Uranium Backup and restart the machine.
54. The VisionScan software recovery is complete.

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ALARM LIST

ID NAME DESCRIPTION THRESHOLD CLASSIFICATION


5000 Low air Displayed when any <5Bar Warning
function is engaged where
pneumatics are required
and the inlet pressure
sensor is reading a value
lower than specified limit.
5001 Close Displayed when any N/A Warning
drawer function is engaged where
the drawer must be closed
and the drawer sensor
cannot detect that the
drawer is closed.
5002 Pressure Displayed if target pressure 20seconds Alarm
timeout during test cycle is not
achieved within a specified
period.
5003 Vacuum Displayed if target vacuum 20seconds Alarm
timeout during test cycle is not
achieved within a specified
period.
5004 LED 1 fault Displayed if LED 1 has not <5 (range 0 Alarm
been illuminated correctly – 255 8 bit
during test cycle. greyscale)
5005 LED 2 fault Displayed if LED 2 has not <5 (range 0 Alarm
been illuminated correctly – 255 8 bit
during test cycle. greyscale)
5006 LED 3 fault Displayed if LED 3 has not <5 (range 0 Alarm
been illuminated correctly – 255 8 bit
during test cycle. greyscale)
5007 LED 4 fault Displayed if LED 4 has not <5 (range 0 Alarm
been illuminated correctly – 255 8 bit
during test cycle. greyscale)

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ID NAME DESCRIPTION THRESHOLD CLASSIFICATION


5008 Camera Displayed if camera is not N/A Alarm
fault detected.
5009 NI USB Displayed if NI USB is not N/A Alarm
detected.
5010 Leak test Displayed if change in Set in Warning
failed pressure is greater than registry.
delta pressure value.
5011 Safety Displayed if drawer is N/A Alarm
circuit open opened while nest is raised
5012 Calibration Displayed if calibration Set in Warning
expired period has been exceeded. options.
5013 Service Displayed if service period Set in Warning
expired has been exceeded. options.
5014 Calibration Calibration is due to expire. Set in Warning
reminder options.
5015 Service Service is due to expire. Set in Warning
reminder options.
5016 Low air Displayed when any Set in Alarm
function is engaged where registry.
pneumatics are required
and the inlet pressure
sensor is reading a value
lower than specified limit.
5017 Raise up Displayed when nest up Set in Alarm
timeout position has not been registry.
achieved inside a specified
amount of time after being
called.
5018 Raise down Displayed when nest down Set in Alarm
timeout position has not been registry.
achieved inside a specified
amount of time after being
called.

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ID NAME DESCRIPTION THRESHOLD CLASSIFICATION


5019 Out of Displayed when method Set in Alarm
range - pressure parameters are registry.
Pressure out of specified range.
“Pressure parameter
%pressure out of limit:
%pressure_limit”
5020 Out of Displayed when method Set in Alarm
range - vacuum parameters are registry.
Vacuum out of specified range.
“Vacuum parameter
%vacuum out of limit:
%vacuum_limit”

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APPENDIX 1. ELECTRICAL DRAWINGS

DESCRIPTION DOCUMENT No.

Main wiring diagram A106-021-005

Electrical pneumatic layout A106-027-002

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APPENDIX 2. PNEUMATIC DRAWINGS

DESCRIPTION DOCUMENT No.

Pneumatic diagram A106-040-003

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APPENDIX 3. ASSEMBLY DRAWINGS

DESCRIPTION DOCUMENT No.

VISIONSCAN general assembly. T106-001-006

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APPENDIX 4. BILL OF MATERIALS

Sepha Ltd

BOM Report

Qty
T106-801-002 VisionScan Operational Spares
A106-006-001 Retension Frame Assembly 1.00
P1000-144 Screw Shoulder Socket Cap Head 6Dx20LxM5 4.00
P1000-764 12mmCompression Spring, Rate 0.26N/mm, OD 9.143mm, Free Leng 4.00
P106-027-002 Retension Frame 1.00
P110-224-001 Retension Frame Upper Magnetic 1.00
A106-015-001 Calibration Plate 1.00
P1000-792 X-rtie ColorChecker 18% Gray Balance 1.00
P106-032-002 Calibration Plate P-touch Label 1.00
P1000-697 O Ring Solid Cord 3mm 1.00
P1000-766 Feet Stops 4.00
P106-017-003 Nest Insert 1.00
P106-033-001 VisionScan Rubber Mat 1.00
P1000-759 Rubber WRAS Approved EPB Sheet 1x1.4 x1.5m 0.10
P2000-781 24V PSU External 1.00

T106-802-001 VisionScan Strategic Spares


A106-020-002 VisionScan Mini PCB Assembly 1.00
A106-040-001 NUC PC Assembly 1.00
P2000-771 NUC PC 1.00
P2000-772 4GB RAM 2.00
P2000-773 128GB M.2 SSD 1.00
P2000-774 Window s 10 Pro License 1.00
P2000-775 USB 3 HUB 1.00
P110-503-002 Perspex Lid 1.00
P2000-678 Computer Camera Lens 1.00
P2000-722 Basler Pulse Camera 1.00
P2000-723 Lens spacer 1.00
P2000-724 LED Lights 4.00
P2000-729 Safety Sw itch 1.00
P2000-737 Reed Sw itches Dual 1.00
P2000-741 12.1" Touchscreen 1.00
P2000-762 NI USB 6002 OEM 1.00
P2000-768 M8 Connector IDCT 6.00
P2000-778 M5 Female Single Ended Cable 3M 4.00
P3000-324 Valve Soft Start 1/4" 24Vdc 1.00
P3000-464 Analogue Compound Pressure Sensor 1.00
P3000-465 Vacuum Regulator 1.00
P3000-469 Manifold 1.00

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APPENDIX 5. OEM DATA

OEM data stored on customer CD


Basler Pulse camera EQ10-BASLER-PULSE-CAMERA
Camera lens COMPUTAR LENS - M0814-MP2
LED Lights EQ4-BALLUFF-LED-BAR-LIGHT
EQ4-BALLUFF-LED-BAR-LIGHT-2
Touchscreen IPC LILLIPUT-OF1211-C-T
Chamber sensor EQ18-EQ19-PRESSURE-SENSOR-PSE540

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APPENDIX 6. DECLARATION OF CONFORMITY

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EU DECLARATION OF CONFORMITY
Name of manufacturer or supplier: SEPHA LIMITED
Full postal address including country of origin: UNIT 25, CARROWREAGH BUSINESS PARK,
CARROWREAGH ROAD
DUNDONALD, BELFAST
BT16 1QQ
NORTHERN IRELAND

EU DECLARATION OF CONFORMITY

Description of Product: NON-DESTRUCTIVE LEAK TESTER FOR BLISTER


PACKAGING
Name: VISIONSCAN

Model Number: T106-______-______

Serial Number: ______-______

The object of the declaration described above is in conformity with the relevant community
harmonization legislation:
• European Machine Directive 2006/42/EEC
• European Low Voltage Directive 2014/35/EU
• European Electromagnetic Compatibility Directive 2014/30/EU
YEAR OF AFFIXATION OF THE CE MARK: 2018
Reference to the relevant standards:
• CEN BS EN ISO 12100:2010 (Safety of Machinery. General principles for design. Risk Assessment
and risk reduction)
• Cenelec BS EN 60204-1:2016+A1:2009 (Safety of Machinery. Electrical equipment of machines.
Specification for general requirements)
• CEN BS EN ISO 13849-1:2015 (Safety of Machinery. Safety-related parts of control systems.
General principles for design)
• Cenelec BS EN 62061:2005+A2:2015 (Safety of machinery. Functional safety of safety-related
electrical, electronic & programmable electronic control systems)
Place of Issue: BELFAST

Name of Authorised Representative: _________________________________

Position of Authorised Representative: _________________________________

Signature of Authorised Representative: _________________________________

Date: _________________________________

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APPENDIX 7. SEPHA LTD WARRANTY DOCUMENT

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