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Dynascan MediTEST, User Manual

The Dynascan MediTEST is an advanced medical testing device that helps monitor vital health parameters. With its user-friendly interface, this product ensures accuracy and convenience. Want to get started? Don't worry, we've got you covered! Download the free user manual from our website to explore all the features and functionalities.

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D012

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057

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2                     MediTEST User Guide                 Page 8

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1

 

USER AND PASSWORDS

 

8.1 USER ACCOUNTS OVERVIEW

 

Users of the system are issued with a Username and password. Each user can  be allocated a

 

permission to access (or not) the user interface panels (screens) and certain front panel controls. There 

are no specific group settings, other than exists in any SOP documentation. If a user is denied access 

to a function, then their name does not appear in the drop

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down list for that function.

 

SECTION 8: USERS AND PASSWORDS

 

This section describes:

 

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User accounts overview and settings

 

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Adding a new user

 

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Setting user access privileges

 

• 

Retiring and temporally disabling a user

 

Summary of Contents for MediTEST

Page 1: ...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 ...

Page 2: ...en 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 res...

Page 3: ... 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 ma...

Page 4: ... 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 genera...

Page 5: ...tion 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 in...

Page 6: ...ber 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 messag...

Page 7: ... 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 Preven...

Page 8: ...he 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 h...

Page 9: ...lt 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 ...

Page 10: ...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 N...

Page 11: ...diTEST 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 ...

Page 12: ...se 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 ...

Page 13: ... 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 S...

Page 14: ...leted 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 ...

Page 15: ...ribes 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 ...

Page 16: ...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 posi...

Page 17: ...cular 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...

Page 18: ...ator 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 do...

Page 19: ...essing 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 s...

Page 20: ...iting 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 keyboa...

Page 21: ...on purposes then the Administrator responsible person should make some basic configuration checks before first use as it is possible that some setting may have been altered during set up such as for illustrative training purposes This section highlights the basic features and functions that should be checked against for correlation with the corresponding configuration tables The diagram below show...

Page 22: ...system powers up the FRONT PANEL screen will be displayed This may indicate some product identification information This will be checked for validity You may be asked for a User Name Administrator and Password during the following steps PARAMETER SETTING User Name Method Product Batch ...

Page 23: ...tables below PARAMETER SETTING System Leak Rate Leak Test Time Leak Test Stab Test Vacuum PARAMETER SETTING Load Cell Range Over range PARAMETER SETTING Vac Drop Time Out Release Vac PARAMETER SETTING Calibration days Reminder days PARAMETER SETTING Password Expire Password Retries Password Min Length Auto Logoff Case Sensitive Logon to Test PARAMETER SETTING Delimiter ...

Page 24: ... 057 2 MediTEST User Guide Page 5 4 INITIAL CONFIGURATION 5 3 SYSTEM SETTINGS CONTINUED Access the SYSTEM SETTINGS screen PARAMETER SETTING Export Path Copy Path PARAMETER SETTING Data File Format Delimiter ...

Page 25: ...AD CELL CALIBRATION screen Select Load Cell 1 check settings then select Load Cell 2 and check the settings PARAMETER LOAD CELL 1 SETTING Sensor Voltage Force Value Adjusted Force Set Zero Set Mid Set Span Use Adjusted Calibration PARAMETER LOAD CELL 2 SETTING Sensor Voltage Force Value Adjusted Force Set Zero Set Mid Set Span Use Adjusted Calibration ...

Page 26: ...M SENSOR CALIBRATION From the SYSTEM SETTINGS screen access the VACUUM SENSOR CALIBRATION screen It should correspond to the settings indicated in the tables below PARAMETER VACUUM SENSOR SETTING Sensor Voltage Vacuum Value Adjusted Vacuum Set Zero Set Mid Set Span Use Adjusted Calibration ...

Page 27: ...N 5 4 THE USER ACCOUNTS PANEL Access the USER ACCOUNTS screen As this screen displays settings corresponding to the selected user their setting cannot be tabulated The Administrator will have full access to all functions and all Function indicator will PASSWORD ...

Page 28: ...ELECTOR screen The current Product or default one should correspond to the settings indicated in the tables below any other product will not PARAMETER SETTING Trial No Batch Record Print Result button Print Report button Show Results button PARAMETER SETTING Select Product Description Uses Method Current Batch ...

Page 29: ...the TEST METHOD screen The Test Method selected in the PRODUCT SELECTOR and shown on the front panel should be selected Ensure it corresponds with the table below PARAMETER SETTING Target Vacuum Stabilise Time Leak Test Time Leak Limit Gross Level Trial Not Saved PARAMETER SETTING Method Name ...

Page 30: ... free USB socket and is switched on Switch on power to the MediTEST at the rear IEC socket The system will take approximately 20 seconds to activate before the FRONT PANEL is displayed as in Fig 6 1 Switch on the Compressed air supply Ensure it is in the range 5 5 7bar 6 bar nominal pressure The system is now ready to start testing packs It will employ the currently indicated test method however i...

Page 31: ...Note some functions are discussed elsewhere in the relevant section of this document LOG OUT Refer to Section 6 3 5 VACUUM PACK results indicators Refer to section 6 3 Figure 6 2 Starts a test cycle This function can be configured Log in free Allows a Batch Record to be closes and a new one opened Access authority These fields are populated from the PRODUCT SELECTOR Allows access to the MENU scree...

Page 32: ...AUDIT LOG button on the FRONT PANEL No password is required The current Audit Log file is displayed by default Historical ones my be selected from the drop down menu shown in Fig 6 3 Press OPEN to select or CANCEL to exit Figure 6 4 shows an example Audit Log one is created every day To print the log press PRINT ensure a printer is on line or CLOSE to exit Figure 6 3 Figure 6 4 ...

Page 33: ...Note that the drawer is retained in the closed position by magnets so there will be some initial resistance The Product Platforms are linked to the Drawer front and are withdrawn from the test chamber at the same time Do not apply excessive downward force on the drawer mechanism The test positions are numbered 1 to 4 left to right and correspond to Pack 1 to Pack 4 on the FRONT PANEL screen CAUTIO...

Page 34: ...o record which test position in which it will be located Place the pack centrally on the Product Platform If a Product Nest is employed insert the pack into the receptacle Do not apply any pressure to the Product Platforms Close the drawer slowly until it locks in position On the FRONT PANEL press the button START TEST CAUTION Figure 6 6 ...

Page 35: ...ssure if there is not an error message will be displayed See Section 6 6 5 The sensor mechanisms will be activated These bring the sensing components into contact with the pack 6 Do not attempt to open the drawer during the test cycle 7 The vacuum pump will start EVACUATION PHASE and the vacuum indicator will display the vacuum level as it increases See fig 6 4 8 As the vacuum increase the Pack in...

Page 36: ...6 6 2 During the STABILISE phase some change in force may be noticed As this is likely due to the change in pressure adiabatic effects the values are not included in the test result calculations 6 3 3 THE DECAY TEST PHASE 1 After the STABILISE phase the DECAY TEST phase is entered This is to detect pinhole size leak paths The Pack indicators now to show the change in force that may indicate a leak...

Page 37: ...ing mechanism is reset for the next test At the end of the VENT phase the Test results are posted The operator may interrogate system by touching on the RESULTS INDICATOR This will invoke the RESULTS PANEL See Section 6 4 Figure 6 7 Press one of these buttons to view the associated RESULTS SCREEN Figure 6 8 Press this buttons to return to the FRONT PANEL you can select another result to view ...

Page 38: ...Pack position These values appear in the Test Report and Batch Records Figure 6 9 Graphical representation of the vacuum level and reactive force generated over the test phase Unique test number Refer to this in the Data Manager Press to save the current screen image A dialog will open to facilitate this Press to print the current screen image Ensure a printer is online ...

Page 39: ...of a session or before a period of inactivity the user may log out of the control system and exit to the operating system log in screen To log out of the system press the button on the LOG OUT button This does not require a password Press to LOG OUT and exit to the Windows log on screen Figure 6 10 ...

Page 40: ... with the Test Method in use The Test Vacuum Method is Check SYSTEM SETTINGS and ensure sensor settings are correct Ensure correct test method is being used The test chamber vacuum drop exceeds the specified level Vac Drop setting too low relative to the Target Vacuum or Leak Test Time System leak has occurred Check SYSTEM SETTINGS and ensure Vac Drop Setting is correct If a leak is suspected chec...

Page 41: ...RODUCT SELECTOR screen If a different PRODUCT is selected then the last used Batch Record if still open applicable to that PRODUCT will be appended This section describes the use of batch records for currently Installed Products Batch Records can be closed and opened for the current PRODUCT from the FRONT PANEL NOTE It is possible to close a Batch Record without opening a new one It is still possi...

Page 42: ...een the Batch Record report will be printed A dialog box will then open asking Do want to OPEN a new batch record Press the YES button to open a new the Batch Record or press NO not to A dialog box will open asking Please Enter a New Batch Name Enter the new name in the space provided Press ENTER to confirm this or CANCEL to abandon If you do not want to open a new Batch record at this time and ha...

Page 43: ...e panels screens and certain front panel controls There are no specific group settings other than exists in any SOP documentation If a user is denied access to a function then their name does not appear in the drop down list for that function SECTION 8 USERS AND PASSWORDS This section describes User accounts overview and settings Adding a new user Setting user access privileges Retiring and tempor...

Page 44: ...uired values via a keyboard or the increment decrement controls as described in Fig 8 1 and press ENTER to save or CANCEL to abandon Figure 8 1 Specifies the number of days a password is valid before the user is required to generate a new one Specifies the number of number of times an incorrect password may be entered before the user account is disabled Specifies the minimum number of characters a...

Page 45: ...screen Press CREATE USER button A dialog will open Please Enter a new USER NAME Enter a new user name This has to be unique you cannot reuse names Press ENTER to continue or CANCEL to abandon A dialog box will open Your Password Has Expired Please Enter a New One The new user should enter a new password A second dialog box will open Please re enter your password Re enter the same new password Note...

Page 46: ... down The User Name cannot be re issued The audit data associated with the retired user will be retained To retire a User Open the USER ACCOUNTS screen Select the USER NAME from the dropdown menu to display their details Press the RETIRE USER button This dialog box will open Press YES to continue or NO to abandon This dialog box will then open Press YES to continue or NO to abandon The user is now...

Page 47: ... time Dynascan will always be able to provide advice on developing a new method Dynascan can also undertake on site method development For the default Test Method installed on the system to which this document relates refer to Section 5 6 If multiple Test Methods have been installed they are documented in in Section 15 SECTION 9 TEST METHODS This section describes The installed delivered test meth...

Page 48: ...uated over a range bracketed vacuum levels This process will have to be repeated for each pack format that is required to be tested with this method The table below indicate the range of usable forces that may be generated by a given surface area for a range of vacuum levels TEST METHODS Vacuum mbar 200 400 500 550 600 650 700 Area cm2 1 200 400 500 550 600 650 700 2 400 800 1000 1100 1200 1300 14...

Page 49: ... Not allowing for this effect could cause erroneous Decay Test results due changes in force changing as a function of temperature rather than a leak Times of between 10 and 20 seconds are normally adequate however the time may more accurately be set by fully developing the test method by multiple iterations and adjustments Generally the harder the vacuum the less the adiabatic effect has on the re...

Page 50: ...test The Decay phase of the test cycle is designed to detect small leaks Packs that pass the Gross test will either be good or contain a small leak path During the Decay test phase the quiescent force exerted by a pack will either change very little or gradually decrease A pack with a small leak will tend to indicate a decay in force as its internal air pressure drops This change in force is monit...

Page 51: ... simple criteria is a good way of easily judging it Also larger packs exert larger forces so this parameter is widely adjustable to allow testing of a wide range of packs Figure 9 4 illustrates this Normally all good packs will exhibit a characteristic ability to generate the specified initial force level during the evacuation time However a pack may 1 Not achieve the initial force due to containi...

Page 52: ...VIEW The PRODUCT SELECTOR screen is where a pack testing configuration is defined It facilitates the testing of different pack formats simply by selecting the Product Name 10 2 CREATING A PRODUCT DEFINITION In the MENU screen select PRODUCT SELECTOR Press CREATE PRODUCT This dialog box will open Press YES to continue or NO to cancel ...

Page 53: ...D In the MENU screen select PRODUCT SELECTOR Press CREATE PRODUCT This dialog box will open Press YES to continue or NO to cancel This dialog box will then open Enter the new Product Name and press ENTER or CANCEL to abandon The new product name must not already exist otherwise this error message will be posted ...

Page 54: ...e Select a Test Method from the drop down menu A method may need to be developed See Section 9 Set this control to allow or not allow the operator to view the RESULTS screen Check this box to run a TRIAL BATCH This does not save a batch record Set this control to print or not print a test report at the end of each test 10 4 PRODUCT SELECTOR FUNCTIONS The NEW BATCH function may be activated at this...

Page 55: ...is panel when setting user privileges System parameter settings are critical to the system operation and should only modified by trained personnel or under the direction of Dynascan CAUTION 11 2 SYSTEM SETTINGS DISCUSSED ELSEWHERE There are some functions on the SYSTEM SETTINGS screen that relate to functions discussed elsewhere in this document these are VACUUM CALIBRATION Refer to Section 12 2 L...

Page 56: ...T AND COPY PATHS The Audit files may be exported in their encrypted form to the destination as set in the EXPORT PATH control The path should be entered into this field The Audit files may be copied in a human readable form to the destination as set in the COPY PATH control The path should be entered into this field 11 3 2 RESULTS FILES DELIMITER The delimiter used in human readable results files ...

Page 57: ...e EXPORT AUDIT or the CSV AUDIT button A dialog screen will open see Fig11 3 select the required file and press SELECT A second dialog screen will open to set the required destination The file name and destination will be indicated these can however be changed Press SAVE Pressing CANCEL in either screen will abandon the action Figure 11 3 Figure 11 4 ...

Page 58: ... operating system not the log in screen press EXIT TO WINDOWS The dialog box fig 11 6 will be displayed Press YES to exit or NO to cancel Figure 11 6 Figure 11 5 11 5 ENGINEER FUNCTIONS The functions listed below are for system engineering purposes They should only be accessed by trained personnel and under the instruction of Dynascan ...

Page 59: ...TEST is factory calibrated with instruments traceable to national standards Recalibration may be carried out on the customer s site during a system service strip down Users are able to verify the calibration status of the MediTEST by the use of a System Verification Kit Type 1 M012 031 available from Dynascan If the verification process reveals variations in response or system drift is it possible...

Page 60: ...trols as described in Fig 12 1 and press ENTER to save or CANCEL to abandon 12 3 LOAD CELL SETTINGS The Load Cell Settings parameters are critical to the system function They should not be modified unless under the direction of Dynascan They should be as is listed in section 5 3 Do not modify these settings If this screen is accessed press CANCEL to exit safely CAUTION Specifies the number of days...

Page 61: ...d Cell to be checked When there is no load applied to sensor platform the Sensor Voltage and Force Value readings should be very similar to those stated in Section 5 3 1 If they are not contact Dynascan for advice If the Use Adjusted Calibration box is set GREEN check that it was set in this state on purpose Consult Section 5 3 1 or a service report that overrides this and confirms a change Figure...

Page 62: ...d similar to Fig 12 3 These should be as listed in section 5 3 If they are not or there is no documentation relating to their current setting then contact Dynascan for advice Figure 12 5 To perform a System Leak Test Ensure no packs are inserted into the test chamber and close the Drawer Enter the SYSTEM SETTING screen and press SYSTEM LEAK TEST Fig 12 6 Press START The leak test cycle will execut...

Page 63: ... list can be supplied on the customer s request 13 3 PREVENTATIVE MAINTENANCE To keep your instrument in good working order the following routine maintenance schedule should be observed The intervals quoted are the minimum 13 3 1 GENERAL Replace the pack sub plate and pressure plate mats if they become soiled 13 3 2 WEEKLY Clean out the test chamber as detailed in Section 12 4 1 Check the drawer s...

Page 64: ...lying IEC connector Ensure that the end of this cable is not allowed to come into contact with any liquid The exterior of the instrument can be cleaned with a cloth moistened with water detergent solution or with non aggressive solvents such as industrial methylated spirit or isopropyl alcohol The use of solvents such as ketones is not recommended as they may attack some plastic parts of the machi...

Page 65: ...wing is a list of recommended spars that may be kept 14 2 ACCESSORIES SPARES AND ACCESSORIES SECTION 14 SPARES AND ACCESSORIES This section describes Critical spare parts Accessories current and in development SPARES DESCRIPTION NUMBER PART NO ACCESSORY DESCRIPTION PART NO ...

Page 66: ... The Product Platform is not fitted with any Porvair 15 1 2 PRODUCT NESTS This system employs Product Nests to ensure consistent location within the testing area The Nests are place directly onto the Product Platform and are located by slots in their bases Note that these have a front to back orientation and should be replaced correctly Figure 15 1 Note position of locating slots ...

Page 67: ...magnets so there will be some initial resistance The Product Platforms are linked to the Drawer front and are withdrawn from the test chamber at the same time Do not apply excessive downward force on the drawer mechanism The test positions are numbered 1 to 4 left to right and correspond to Pack 1 to Pack 4 on the FRONT PANEL screen CAUTION Figure 15 2 Insert sample into nest aperture Product Nest...

Page 68: ...caled Value mbar Tol mbar 16 1 1 CALIBRATION SETTINGS AS DELIVERED This is to certify that The Vacuum sensor and Load Cells were calibrated as detailed below with equipment traceable to national standards Calibrated By Signature Date John Evans Equipment Serial Number Calibrated Range Vacuum Meter Digital Multi meter M2 Test Weight M2 Test Weight M2 Test Weight Applied Mass g Load Cell 1 V Load Ce...

Page 69: ...to certify that The Vacuum sensor and Load Cells were calibrated as detailed below with equipment traceable to national standards Calibrated By Signature Date Equipment Serial Number Calibrated Vacuum Meter Digital Multi meter M2 Test Weight 500g 1 M2 Test Weight 1000g 2 M2 Test Weight 2000g 3 4 5 6 Applied Mass g Load Cell 1 g Load Cell 2 g Load Cell 3 g Load Cell 4 g ...

Page 70: ...to certify that The Vacuum sensor and Load Cells were calibrated as detailed below with equipment traceable to national standards Calibrated By Signature Date Equipment Serial Number Calibrated Vacuum Meter Digital Multi meter M2 Test Weight 500g 1 M2 Test Weight 1000g 2 M2 Test Weight 2000g 3 4 5 6 Applied Mass g Load Cell 1 g Load Cell 2 g Load Cell 3 g Load Cell 4 g ...

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