Disintegration Tester ZT 72x Instruction Manual

Transcription

1 Disintegration Tester ZT 72x Instruction Manual

2 Document version: 7.0 Date: Firmware version: from 1.14 Document no.: File name: ZT 72x_Manual_20016_En_V7.0 Language: English Page number: 88 Version table Date Document version* Amendment New New firmware version CE New firmware version Note about repeated switch-on New firmware version New firmware version Editorial revision Note about ambient temperature New firmware version New firmware version 1.14 * When the document version X.Y is increased, X means a technical change and Y a document amendment only. Copyright The material in this document is the intellectual property of ERWEKA. Any copy or reproduction of this document or its parts without the written permission of and reference to ERWEKA is prohibited and will be prosecuted according to the law. All trademarks are the property of their respective owners. Copyright 2018 by ERWEKA

3 Instruction Manual Disintegration Tester ZT 72x

4 Table of Contents 1 Introduction About this instruction manual Service Hints and symbols Protection of the environment 6 2 Safety Safety information Intended use 7 3 Overview Description Type label Construction Operation elements and connections Baskets Technical data 13 4 Installation Storage and transport conditions Unpacking and checking Installation Positioning Acclimatization Required installation environment Assembling the device Mounting the baskets Connecting and switching the device on 17 5 User Interface Overview Entering numbers and strings Main screen 20 6 User Login 21 7 User Management Adding a new user account Editing a user account Information about current user De-/activating a user account Changing the password of current user Printing the logbook Configuring the user settings Processing the audit trail 27 8 Product Management Adding a new product Editing a product De-/activating a product Printing the product report and list Basket Management Adding a new basket Editing a basket Printing the baskets list Configuring the Settings Device settings Printer settings Date and time settings Temperature settings Hardware settings Network settings Export settings Firmware update Backup Preheating schedule Adjustment Temperature adjustment Height adjustment Restore of the temperature adjustment Viewing the adjustment dates Operational Qualification (OQ) Water bath temperature check Runtime check Dipper speed check Dipper height check Zero point check Setting the PV date Viewing the OQ/PV dates Configuring the OQ settings Registering the measuring devices Performing the Tests Direct measurement Measurement Results Cleaning Instructions for cleaning Inspection and maintenance In longer standstills Spare parts 73 Attachment 74 Measurement reports 74 Adjustment / calibration reports 76 Glossary 85 9 Medium Management Adding a new medium Editing a medium Printing the media list 35

5 ZT 72x Introduction 5 1 Introduction Thank you for purchasing the ERWEKA disintegration tester type ZT 72x. 1.1 About this instruction manual This instruction manual supports you in work with your ERWEKA device. It describes the device, its operation and gives you useful tips on its handling. Furthermore, read descriptions of installation and setting as well as detailed step-by-step work operations in the present manual. Pictures facilitate the understanding of processes described here. Read this manual completely before using the device and make sure you understand its content. The instruction manual is a part of the product. Keep this manual in a safe place so that it will be available for any questions at a later date. This is important for long-term and accurate function of the corresponding device. The editorial team of ERWEKA appreciates your feedback regarding the present manual. Just send an to quality@erweka.com with your topic and technical documentation as a subject. Your feedback will also help us to meet our own high quality requirements. 1.2 Service Contact ERWEKA at support@erweka.com to order spare parts, in case of technical questions or possible repairs. Please supply the following information: Type of the device (on the type label) Serial number of the device (on the type label) Short description of the case

6 6 ZT 72x Introduction 1.3 Hints and symbols WARNING indicates a possible hazardous situation which, if not avoided, could result in death or serious injury. HAZARD of electric shock! Indicates a possible hazardous situation which, if not avoided, can lead to injuries caused by electric shock. This symbol indicates a possible hazardous situation which, if not avoided, can lead to equipment damage or data loss. This symbol indicates information that will ensure smooth work processes. This symbol provides you with additional useful information. 1.4 Protection of the environment Note that product residues must be properly disposed of in accordance with the respective valid environmental legislation. According to the valid EC directives all the electrical parts (electrical scrap) must be disposed of appropriately.

7 ZT 72x Safety 7 2 Safety 2.1 Safety information To guarantee the health and safety, read the following safety instructions before using the device. WARNING Wear the personal protective outfit and, if needed, the glasses! HAZARD of electric shock! Electric devices are to be plugged into safety sockets only! Use the delivered network cable! The voltage of the existing current supply has to meet the requirements of the type label! Before installation works always switch the corresponding device off and disconnect it from the rear panel. ERWEKA devices should be operated by qualified and trained personnel only! Pay attention to the on-site safety instructions for work in the laboratory and with the laboratory equipment! 2.2 Intended use The ERWEKA disintegration tester type ZT 72x should be used only for performing disintegration tests, associated verification and quality control of tablets, dragees, oblongs and other formulations. The requirements for installation environment defined by ERWEKA shall be met. ERWEKA devices should not be used for processing: Products that are easily flammable or explosive Products that develop vapours which may create flammable or explosive mixtures in combination with air Products that release harmful or poisonous substances The device should be operated and maintained only as intended and in accordance with the instructions presented in this manual.

8 8 ZT 72x Overview 3 Overview 3.1 Description ERWEKA disintegration testers are used for testing the disintegration time of solid formulations (e.g. tablets, dragees, oblongs or capsules) according to the prescriptions of the valid pharmacopoeias (USP, EP and JP). During the disintegration test the formulation to be tested is placed in a liquid medium and kept in motion. The formulation disintegration is tested under given conditions within the definite time. A sample is placed into each glass tube of the basket and covered with a disk. After the assembled basket is mounted on the device, it is lifted in and out in a beaker in a previously warmed medium. The medium of constantly maintained temperature flows through the sample until it disintegrates. The disintegration can be achieved when there are no more rests at the sieve bottom or when fragments of the sample coating stick to the cover disk underside. The data (disintegration times, temperatures etc.) is saved for further documentation. The disintegration test as a test method is standardized in the pharmacopoeias. ERWEKA disintegration testers fulfill all pharmacopoeia requirements. An integrated heating system supports the constant distribution of the tempered water in the water bath. The temperature is checked with an external PT 100 temperature sensor. The ZT 72x can be produced optionally with 1 or 2 test stations. The test stations can be controlled individually. They are equipped with an automatic lifter. The basket is automatically lifted out of the the beaker after the end of the set runtime. The down and up speeds of the basket are adjustable. The maximum runtime of the test stations is 99 hours, 59 minutes and 59 seconds. An acoustic beep signals the completion of a test run. The ZT 72x is operated through a touchscreen display in the device upper part. The device has different interfaces (USB A, USB B, LAN and SD card) and can be connected to a printer Type label The type label is placed on the rear panel of the device and contains following data: ERWEKA GmbH D Heusenstamm / Germany Typ: Serial No: xxxxxx.xxxx PN : VA IN : A U : V F : Hz Typ: Device type Serial No: Serial number P N : Rated output in volt-ampere [VA] I N : Nominal current in ampere [A] U: Voltage in volt [V] F: Frequency in hertz [Hz]

9 ZT 72x Overview Construction Fig. 1 ZT 72x with two test stations 1) Touchscreen display 2) Support arm 3) Basket 4) Beaker 5) Water bath 6) External PT 100 temperature sensor

10 10 ZT 72x Overview 3.3 Operation elements and connections Device front panel Fig. 2 Device front panel 1) Touchscreen display 2) Connections for the heating from the water bath (inlet and outlet) Information about the touchscreen display you will find in chapter 5 User Interface. Device rear panel Fig. 3 Device rear panel with fill tube and lock valve

11 ZT 72x Overview Fig. 4 Connections and switch in the upper area of device rear panel 1) Main switch 2) Power supply 3) USB B 4) USB A for printer 5) LAN connection 6) Slot for SD card (memory card) 7) Connection for external PT 100 temperature sensor Used storage media, such as USB stick or SD card, must be formatted in FAT 32! Otherwise data can be lost. ERWEKA accepts no liability for data loss caused by usage of improperly formatted storage media and for wrong connection. ERWEKA recommends the usage of the SanDisk Extreme 16 GB USB stick.

12 12 ZT 72x Overview 3.4 Baskets First, the baskets differ in type according to their equipment, i.e. the number and size of the incorporated glass tubes. Type Number of glass tubes Switching distance A 6 glass tubes ± 0.5 mm B 3 bigger glass tubes ± 0.9 mm Second, the baskets differ in their construction type. There are AutoBaskets and standard baskets. AutoBaskets Fig. 5 Fig.: AutoBasket type A quick-clean with glass tubes and cover disks Sensors responsible for the detection of the tablet disintegration are located at the bottom of these baskets. Standard baskets Fig. 6 Basket type A with glass tubes and cover disks These baskets have no sensors. They are connected directly to the support arms.

13 ZT 72x Overview Technical data ZT 72x Dimensions Height [mm] 679 Width [mm] 365 Depth [mm] 440 with fill tube and lock valve Weight [kg] Compliance USP / EP / JP Power supply VAC / Hz / 16 A Power consumption max Watt Number of test stations optional: 1 or 2 Safety Protection class I / EN Protection type IP 21/ IEC 529 Height of stroke 55 ± 2 mm Speed 30 ± 1 stroke/min Basket type A and B Temperature control external PT 100 temperature sensor Temperature range C ± 0.2 C Heating integrated flow-through heater Water bath acrylic glass Operation 7 touchscreen display Runtime variable adjustable up to 99 h, 59 min, 59 s ±1 s Lift in / out automatic lifting in and out when starting / stopping stroke actuation with step motor Start time automatic lifting in and out when starting / stopping Automatic detection of disintegration time usage of AutoBasket is possible Acoustic signal available Interfaces USB A, USB B, LAN and slot for SD card Housing material lacquered metal Printer optional Memory function 4 GB for 100 products / users / methods and approx. 1 million test results DSV Server for saving XML and CSV files and their transfer to other PCs

14 14 ZT 72x Installation 4 Installation 4.1 Storage and transport conditions Temperature and humidity should not exceed or fall below the values defined by ERWEKA (see Required installation environment). During the carriage you have to ensure that the used technical means comply with the prescribed safety requirements. 4.2 Unpacking and checking After receipt of the delivery, check the packaging and the device for transport damage. On some packages you can see indicator labels, which change their colors in case of improper transporting. Check these labels for discoloration. Check the screw connections, fittings and armatures! They may have loosened during the transportation! If undue transporting or any damage is evident, take a photo of this and send it to our ERWEKA Service immediately. 4.3 Installation Positioning Position the device on a horizontal, plane, stable surface, e.g. on a laboratory table, and pay attention not to displace it during the operation. For ease-of-use and accessibility, when positioning the device ensure that there is sufficient distance towards walls, cabinets or other fixed components of the facility. Besides sticking to the requirements for installation environment defined by ERWEKA, avoid the following: Heat (heating, insolation) Direct draught through open windows, doors or air conditioning and ventilating systems Vibrations Dampness Acclimatization If a cold device is moved to a warm environment, condensation may occur. Therefore you should allow the device to acclimatize for approximately two hours at room temperature, leaving it unplugged.

15 ZT 72x Installation Required installation environment Ambient temperature in operation: Storage and transport temperature: Relative humidity: +10 C up to +30 C +5 C up to +40 C 25-80% no condensation For testing the ambient temperature must be at least 5 C colder than the nominal temperature of the water bath. 4.4 Assembling the device After the device has been positioned, the assembly and preparation to operation can be started. B I G H A D E C F Procedure: 1. Ensure that the main switch on the device rear panel is in the OFF position. 2. Remove the water bath with its covering [D]. For this loosen the four knurled-head screws [C]. 3. Place the water bath to its initial position. 4. Place the tubes (outlet and inlet) into the corresponding connection nozzles [E]. 5. Fill the water bath with demineralized water up to the mark [F]. Use the tube on the device rear panel. Check the water bath and connection tubing for leakages. Damages of the heating system and pump! The bath must be filled with water. The pump must be primed with water. There should be no air in the system. Ensure that the water is flowing in and out of the inlet tube.

16 16 ZT 72x Installation 6. Plug the network cable of the device into a safety socket. Electric devices are to be plugged into the safety sockets only! The voltage of the existing power supply has to meet the requirements of the type label. ERWEKA accepts no liability in case of wrong connection. 7. Check the functioning of the heating system. If needed, fill the water bath and heating system again. Check the device for leakages. 8. Put the support plate [G] into the water bath. 9. Mount the water bath covering [D] with the four knurled-head screws [C]. 10. Connect the PT 100 temperature sensor [I] and insert it into the corresponding orifice of the water bath covering. 11. Fill the beakers [H] with medium and place them into the orifices of the water bath covering. 12. Attach the baskets [A] to the support arms [B] Mounting the baskets Equipment: The basket disposes of three or six glass tubes according to its type. A position is alloted to each glass tube. The position number is marked on the upside of the basket. The cover disks are marked with numbers (1 to 3 or 1 to 6) for the allotment of their test position. Each set of cover disks has its own color. The cover disks are placed over the samples in the corresponding glass tubes. In case of cover disks with magnets the magnets must point downwards! Pay attention to the mounting direction [A]! A During a test put the cover disks in the right positions according to their numbers.

17 ZT 72x Installation 17 Assembly and disassembly: 1. Turn the basket so that the cable of the measuring head will be located on the left from you. 2. Pull the sleeve on the upper part of the measuring head down. 3. Hold the sleeve down and simultaneously hang the basket in the groove of the support arm. 4. Release the sleeve for latching. 5. Plug the jack of the measuring head into the socket of the support arm from the left (red mark to red mark). 4.5 Connecting and switching the device on Make the required device connections (see 3.3 Operation elements and connections). Power connection The power connection was made for checking the heating system (see 4.4 Assembling the device). Network connections If required, connect the device with the components (printer, PC etc.). For this plug the network cables of the components into the corresponding connections on the device rear panel before the device is switched on. Switching on/off For switching on set the main switch on the device rear panel to the ON position. The user login screen is shown on the touchscreen display. For switching off set the main switch to the OFF position. Too quick repeated switch-on can impair the device functionality. Wait at least 20 seconds before you switch the device on again.

18 18 ZT 72x User Interface 5 User Interface 5.1 Overview The main elements of the ZT 72x display are presented in the picture below Fig. 7 Main screen 1) Main menu 2) Current date and time 3) Current temperature 1 4) Device name (abbreviation) 5) Display and input fields 6) Printer/USB stick connection 2 7) SD card connection 8) LAN connection 9) Button 10) The Login/Logout/Back button 11) Status bar with calibration status 1 No heating symbol - the water bath heating is switched off. - the specified temperature has been reached. - the specified temperature has not been reached. 2 In case of the USB stick the symbol looks like. In case of incompatibility will be displayed. Calibration status Symbol Meaning GREY - The function of calibration status reminder is switched off. GREEN - The current calibrations are in the valid period and tolerance. YELLOW - At least one current calibration is only some days valid! RED - Warning: At least one calibration is expired! The valid period can be set. More about this see in 13.8 Configuring the OQ settings. The Back button The button [10] looks like. Touch Back to return to the last opened window.

19 ZT 72x User Interface Entering numbers and strings Just after touching input fields the additional keypads are shown. They are described below. Time keypad Using the arrows enter the time (hh : mm : ss) here. Numeric keypad Enter numeric values here. Fig. 11 Time keypad Fig. 8 Numeric keypad Touch Ok to confirm the entered value and close the keypad. Alphabetic keypad Button Ok Function Touching this symbol increases the value shown below for 1 (value range: 0-9). Touching this symbol decreases the value shown above for 1 (value range: 0-9). To confirm the entered value and close the keypad. Enter string values (text) here. Calendric keypad Enter the date here. Fig. 9 Letter keypad Fig. 12 Calendric keypad Fig. 10 Sign keypad Button Function / Touching these symbols scrolls the calendar by years. / Touching these symbols scrolls the calendar by months. 1-28/29 or 30/31 Number of the day in the month. Button Funktion To enter capital letters.?123 / ABC To switch between letter keypad and sign keypad. To delete a string value. Ok To confirm your entry and close the keypad. After the year and month select the day by touching its number in the calendar. The keypad is closed automatically after the date selection. You can open the keypad again by touching the input field.

20 20 ZT 72x User Interface 5.3 Main screen The main screen is displayed as soon as a user logged into the device (see 6 User Login). It can be displayed as follows: Here you can see the full name and access rights of the logged in user as well as date and time of his last login. By touching the buttons on the right side you can perform manual and direct measurements and show the results. Button Direct measurement Measurement Results Function Performing a direct measurement. Performing a measurement with stored product data. Display of the results. You can use the main menu (see item 1 in Fig. 7) corresponding to your access rights.

21 ZT 72x User Login 21 6 User Login As soon as you switch the device on, the login screen is shown on the touchscreen display. First login In case of your first login the following message will be displayed. To log into the device: 1. Enter your user name and password on the User login screen: 4. Touch Ok. The screen for password change is displayed. For your first login to the device apply the user name ERWEKA and empty password. The administrator should create a password for himself. 2. Touch Login on the User login screen. The screen to set the heater temperature is displayed. 5. Enter a new password, repeat the entry and confirm it by touching Ok. The new password must differ from the old one and correspond to the specific password requirements. 6. After the successful password change touch Ok. 3. Enter the heating temperature and confirm it by touching Ok. If you do not set the heating temperature at this time, skip step 3 by clicking Cancel. The display changes to the main screen.

22 22 ZT 72x User Management 7 User Management To manage the user accounts, you must have the right for user management. Button User settings Audit-Trail Function Settings for user login and password. Display, export and deletion of the audit data. 7.1 Adding a new user account To manage the user accounts: 1. Enter the main menu by touching in the upper left corner of the touchscreen display. A new user account is created by the administrator. Upon the first login the corresponding user must change the password given by the administrator! To add a new user account: 1. Enter the Users screen. 2. Touch Users. The Users screen appears. 2. Touch Add user. The buttons on the Users screen have the following functions: Button User info Add user Edit user Delete user Deactivate user Activate user Print logbook Change password Function Information about the current user. Adding a new user account. Editing a selected user account. Deleting a selected user account. Deactivating a selected user account. Activating a selected user account. Printing the users list. Changing the password of the current user. 3. Specify the user name, password for login, first and last names.

23 ZT 72x User Management Editing a user account To edit a user account: 1. Enter the Users screen. 4. Select the user access rights by touching the check boxes: User right Measurement Products and media Adjustment Perform OQ Settings User management Baskets Administrator Results Description Performing the manual and direct measurements. Adding, editing, deleting the products and media, de-/activating the products as well as printing the products and media lists. Temperature and height adjustments, display of the adjustment dates. Operational Qualification for temperature, runtime, dipper speed and height, zero point, setting the PV date, viewing the OQ/PV dates and configuring the OQ settings. Settings for device, printer, date and time, temperature, hardware, network, export, firmware update and export/ import of the data. Creating, editing, deleting, de-/ activating the user accounts, changing the password of the current user, printing the users list and display of the user information. Adding, editing and deleting the baskets as well as printing their lists. All rights. Display of the results. 2. Touch Edit user. 3. Select the user account to be edited. Touch Ok. 5. Touch Ok to exit the screen. Each user must have at least one right! 4. Change the data on the User data and Rights tabs. (See 7.1 Adding a new user account.)

24 24 ZT 72x User Management 5. On the Audit-Trail tab you see the following data: Field Meaning Added at Date and time when the user account was added. Added by User who added this account. Pass changed Date and time when the password was changed. Last login Date and time of the user s last login. On the User data tab you see the name, first and last names of the user currently logged in. 6. Touch Reset password to change the password. 7. Touch Ok to exit the screen. 7.3 Information about current user To view and print the information about the user currently logged in: On the Rights tab you see the rights of the user currently logged in. 1. Enter the Users screen. On the Audit-Trail tab you see the following data: 2. Touch User info. Field Added at Added by Edited at Edited by Pass changed Last login Meaning Date and time when the user account was created. User who created this user account. Date and time when the user account was edited. User who edited this user account. Date and time when the password was changed. Date and time of the user s last login.

25 ZT 72x User Management If necessary, touch Print to print the user report. 4. Touch Ok to exit the screen. To activate a user account: 1. Enter the Users screen. 7.4 De-/activating a user account Deactivated user accounts are no more seen among users for editing, but among users for activation. Deactivated users cannot log in anymore and have no rights assigned. To deactivate a user account: 1. Enter the Users screen. 2. Touch Activate user. 2. Touch Deactivate user. 3. Select the user account for activation. Touch Ok. 4. Confirm the message. The selected user account is activated. 3. Select the user account for deactivation. Touch Ok. 5. Touch Ok. Give the user the new password and check his rights. See 7.2 Editing a user account. 4. Confirm the message. The selected user account is deactivated.

26 26 ZT 72x User Management 7.5 Changing the password of current user To change the current user s password: 1. Enter the Users screen. 7.6 Printing the logbook To print the logbook (users list): 1. Enter the Users screen. 2. Touch Change password. 2. Touch Print logbook. 3. Confirm the message by touching Yes. The user logbook is being printed out. New password cannot be equal to the old one and must correspond to the defined pasword requirements. 4. Enter a new password. Touch Ok for confirmation.

27 ZT 72x User Management Configuring the user settings To configure the user settings: 1. Enter the Users screen. Strong passwords are passwords that cannot be easily discovered by intelligent guessing. They contain: Alphanumeric symbols, upperand lowercase letters At least 8 symbols (recommended length is symbols) No repetitions, letter and number sequences, user names, birth dates 3. Touch Back. 7.8 Processing the audit trail 2. Touch User settings. To display the audit trail: 1. Enter the Users screen. On the User settings screen specify the following data: Field Meaning Logout after The time for user logout (5-60 min, 0 - deactivation) Change password The time for password change ( days, 0 - deactivation) Use default When creating new user accounts passwort the password is equal to the user name. Password policy Activate the entry of conditions for passwords. Min. pass. length The minimal password length (3-8 symbols) Complex The strong password (min. one passwords capital letter and one digit) 2. Touch Audit-Trail. 3. Touch View audit log.

28 28 ZT 72x User Management Check previously if the exported data is available and readable! To export the audit trail: 1. Enter the Users screen. 4. Select the period and user in case you want to filter the audit trail. 5. Touch Continue. 2. Touch Audit-Trail. The audit trail for the specified period and user is shown. 3. Insert the SD card or USB stick in the device. 4. Touch Export.

29 ZT 72x Product Management 29 8 Product Management To manage the products, you must have the right for products and media. To manage the products: 5. Select the data source for export. Confirm with Ok. 1. Enter the main menu by touching in the upper left corner of the touchscreen display. Used storage media, such as USB stick or SD card, must be formatted in FAT 32! Otherwise data can be lost. 2. Touch Products. The Products screen is shown. 6. Select the format. Confirm with Ok. 7. Touch Yes to overwrite the old audit file with a new one or No to leave the old audit file. 8. If you have touched Yes in the previous step, confirm the deletion of the audit file from the storage medium. The buttons on the Products screen have the following functions: Button Add product Edit product Deactivate product Activate product Delete product Print Print all Function Adding a new product. Editing a selected product. Deactivating a selected product. Activating a selected product. Deleting a selected product. Printing the product report. Printing the products list.

30 30 ZT 72x Product Management 8.1 Adding a new product To add a new product: 1. Enter the Products screen. Form Core Patch Pellet Pastille Description An extended-release tablet consisting of the core containing the active material and a semi-permeable membrane that coats the core, having a micro drill produced orifice in order to release the active material An adhesive patch applied to the skin A small, rounded or spherical body A flavored lozenge; troche 2. Touch Add product. 4. On the Add. data tab specify the test data: 3. On the Prod. data tab specify the product data for the new product: Field Name Dose Form Medium Temperature XsTime Basket type Meaning Product name Dosage (from 0 to 9000 mg) Formulation (see the next table) Medium Temperature Disintegration time Basket type (type A = 6 glass tubes; type B = 3 glass tubes) You can specify following product forms: Field Meaning XsMaxTime Maximal test time, after which a test is aborted ( 96 min) XsMinTime Minimal test time (the tablets disintegrating before this time are not taken into statistical evaluation and assessed as failed) Distance Distance between the sieve and cover disk at which the tablet is detected as disinitegrated Resist To select a resist phase in a test with the product Resist time Time for the resist phase Resist medium Medium for the resist phase >XsMaxTime Additional parameter for a measurement. If the tablets do not disintegrate till the end of XsMaxTime, the test will continue max. 60 min (XsMaxTime + 60 min.) in case this parameter is selected. If the tablets disintegrate within this time, the test will be finished automatically, but failed. If the tablets disintegrate not within this time, the test will be aborted automatically. Form Oblong Dragee Tablet Caplet Film tablet Capsule Description An elongated tablet A sugar-coated pill A solid dosage form A capsule-shaped tablet A tablet with film coating A solid dosage form in which the drug is enclosed within a hard or soft soluble container ( shell ) 5. Touch Ok.

31 ZT 72x Product Management Editing a product To edit a product: 1. Enter the Products screen. You can also view the audit trail on the corresponding tab: 2. Touch Edit product. Field Added at Added by Edited at Edited by Meaning Date and time when the product was added. User who added the product. Date and time when the product was edited. User who edited the product. 5. Touch Ok. Already used products are marked with an asterisk (*) and cannot be changed anymore. 3. Select the product to be edited. Touch Ok. 4. Change the product data on the corresponding tab. (See 8.1 Adding a new product.)

32 32 ZT 72x Product Management 8.3 De-/activating a product By deactivating the products you make them invisible for selection during a measurement. By activating the products you make them visible for selection during a measurement. Deactivated products are no more seen among products for editing, but among products for activation. To activate a product: 1. Enter the Products screen. To deactivate a product: 1. Enter the Products screen. 2. Touch Activate product. 2. Touch Deactivate product. 3. Select the product to be activated. Touch Ok. 3. Select the product to be deactivated. Touch Ok. 4. Confirm the notification. The selected product will be activated. 4. Confirm the notification. The selected product will be deactivated.

33 ZT 72x Product Management Printing the product report and list To print the product report: 1. Enter the Products screen. To print the product list: 1. Enter the Products screen. 2. Touch Print all. The product list is being printed out. 2. Touch Print. 3. Select the product which report to print. Touch Ok. The product report is being printed out.

34 34 ZT 72x Medium Management 9 Medium Management To manage the media, you must have the right for products and media. 9.1 Adding a new medium To add a new medium: 1. Enter the Media screen. To manage the media: 1. Enter the main menu by touching in the upper left corner of the touchscreen display. 2. Touch Add medium. 2. Touch Media. The Media screen appears. 3. Specify the name and ph value of the new medium. 4. Touch Ok. The buttons on the Media screen have the following functions: Button Add medium Edit medium Delete medium Print all Function Adding a new medium. Editing a selected medium. Deleting a selected medium. Printing the media list.

35 ZT 72x Medium Management Editing a medium To edit a medium: 1. Enter the Media screen. Field Edited at Edited by 5. Touch Ok. Meaning Date and time when the medium was added. User who edited the medium. 9.3 Printing the media list To print the media list: 1. Enter the Media screen. 2. Touch Edit medium. 2. Touch Print all. 3. Select the medium to be edited. Touch Ok. The list of all registered media is being printed out. 4. Change the medium data as needed: Field Name ph Value Added at Added by Meaning Medium name. ph value of the medium at room temperature. Date and time when the medium was added. User who added the medium.

36 36 ZT 72x Basket Management 10 Basket Management To manage the baskets, you must have the right for baskets Adding a new basket To add a new basket: 1. Enter the Baskets screen. To manage the baskets: 1. Enter the main menu by touching in the upper left corner of the touchscreen display. 2. Touch Add basket. 2. Touch Baskets. The Baskets screen appears. 3. Specify the basket number and type (A or B). 4. Touch Ok. A basket of A type has 6 glass tubes, a basket of B type 3 glass tubes. The buttons on the Baskets screen have the following functions: Button Add basket Edit basket Delete basket Print all Function Adding a new basket. Editing a selected basket. Deleting a selected basket. Printing the baskets list.

37 ZT 72x Basket Management Editing a basket To edit a basket: 1. Enter the Baskets screen. Field Edited at Edited by 5. Touch Ok. Meaning Date and time when the basket was edited. User who edited this basket Printing the baskets list To print the baskets list: 1. Enter the Baskets screen. 2. Touch Edit basket. 2. Touch Print all. 3. Select the basket to be edited. Touch Ok. The list of all registered baskets is being printed out. 4. Change the basket data as needed: Field Name Basket type Added at Added by Meaning Serial number of the basket. Type of the basket. Date and time when the basket was added. User who added this basket.

38 38 ZT 72x Configuring the Settings 11 Configuring the Settings To configure the settings, you must have the right for settings. Button Export settings Firmware update Backup Pre-Heating schedule Function (configuration of ) Export mode, format and interface. Firmware update for the boards used in the device, display of firmware versions. Export and import of the selected files, creation of a system copy. Preheating schedule for each day of the week. To configure the settings: 1. Enter the main menu by touching in the upper left corner of the touchscreen display Device settings To configure the device settings: 1. Enter the Settings screen. 2. Touch Settings. The Settings screen appears. 2. Touch Device settings. The buttons on the Settings screen have the following functions: Button Device settings Printer settings Date & time Temp. settings Hardware settings Network Function (configuration of ) Brightness, sound, language, LCD timeout, firm logo and service date. Auto printing, print format, printer type. Current date and time as well as date format. Temperature offset, autostart and maximal deviation. Up and down speed. Current MAC and IP addresses, device name in the network and address type. 3. Configure the device settings: Field Meaning Brightness Display brightness (1 10) Sound Sound for touching the buttons on the screen (On/Off) Language Display language (English or German) LCD timeout Time after which energy saving mode is turned on (Off or 5 60 min.) Company logo Firm logo for reports Service date Date of the last service 4. Touch Back.

39 ZT 72x Configuring the Settings Printer settings To configure the printer settings: 1. Enter the Settings screen Date and time settings To configure the date and time settings: 1. Enter the Settings screen. 2. Touch Printer settings. 2. Touch Date & time. 3. Configure the printer settings: 3. Configure the date and time settings: Field Auto printing Print format Printer type Meaning Setting of the automatic printing mode (switched off, automatic or after question) ASCII or PCL for printing the reports USB or LAN Field Date Time Date format Meaning Setting of the current date. Setting of the current time. Setting of the date format (European, American or Chinese) 4. Touch Back. 4. Touch Back.

40 40 ZT 72x Configuring the Settings 11.4 Temperature settings To configure the temperature settings: 1. Enter the Settings screen Hardware settings To configure the hardware settings: 1. Enter the Settings screen. 2. Touch Temp. settings. 2. Touch Hardware settings. 3. Configure the temperature settings: Field Meaning Temp. offset Temperature offset ( C) Force autostart after Automatic start of the test after 5 60 min., after the test was started by touching the Auto button. Maximal deviation Maximal temperature deviation ( C). Offset (Temperature) This value serves as a compensation of temperature losses during the heat transfer. It is added to the nominal value. Example: When the thermostat is set to a nominal value of 37 C and the temperature offset to 0.5 C, the thermostat will heat the medium up to 37.5 C. In this way the constant temperature value of 37 C is ensured in all containers. 3. Configure the hardware settings: Field Meaning Up speed Up speed of the arm (1 100 %), excavation after test. Down speed Down speed of the arm (1 100 %), dipping before test. 4. Touch Back. We recommend setting 50 % for the up and down speed by default! 4. Touch Back.

41 ZT 72x Configuring the Settings Network settings To configure the network settings: 1. Enter the Settings screen Export settings To configure the export settings: 1. Enter the Settings screen. 2. Touch Network. 2. Touch Export settings. 3. Configure the network settings: 3. Configure the export settings: Field MAC address Current IP Name Address 4. Touch Back. Meaning MAC address of the device. Current IP address of the device. Device name. Address type (DHCP or static). If you select the static address, specify the required IP address, net mask and gate IP additionally. Field Export mode Format Interface IP address IP port Meaning Setting of the export mode (switched off, after question or automatic). Export format (CSV or XML). Port for export (USB, LAN, USB stick or SD card). IP address of the recipient (if LAN was selected). IP port of the recipient (if LAN was selected). DSV Server for saving XML and CSV files and their transfer to other PCs is available. 4. Touch Back.

42 42 ZT 72x Configuring the Settings 11.8 Firmware update To update the firmware: 1. Enter the Settings screen. 5. Select the SD card or USB stick. Confirm with Ok. 2. Touch Firmware update. 6. Select the corresponding checkbox to perform the update. Touch Continue. 3. Select the board (TFT, main or basket) for the update from the list. 7. Wait until the update is installed. 4. Insert the SD card or USB stick with the new firmware in the device. Confirm with Ok.

43 ZT 72x Configuring the Settings After the update has been installed, log in again. 4. Touch Back. To view the firmware versions: 1. Enter the Settings screen Backup To back up the data: 1. Enter the Settings screen. 2. Touch Firmware update. 2. Touch Backup. 3. Touch Firmware versions. 3. Insert the SD card or USB stick in the device. 4. Touch Save.

44 44 ZT 72x Configuring the Settings To restore the data: Perform the same steps as for data backup, but touch the Restore button (not Save) on the Backup screen. After you have restored the data, restart the device. You can save, but not restore test results. 5. Select the data source. Touch Ok. Used storage media, such as USB stick or SD card, must be formatted in FAT 32! Otherwise data can be lost. To copy a system file: 1. Enter the Settings screen. Ensure that there are no old backup files on the storage media. 6. Touch Yes. 2. Touch Backup. 7. Indicate the data for copying by selecting the checkboxes. Touch Ok. 3. Insert the SD card or USB stick in the device. 4. Touch Full system copy. 8. The data is copied. After the end of procedure touch Ok.

45 ZT 72x Configuring the Settings Select the data source. Touch Ok. Used storage media, such as USB stick or SD card, must be formatted in FAT 32! Otherwise data can be lost. 3. Indicate the day of the week by selecting the corresponding checkbox. 6. Wait until the system file is copied. 4. Touch the Status checkbox to activate the schedule for this day. 5. Specify the heating start in the Start field and the heating end in the Stop field. 7. After successful copying touch Ok Preheating schedule 6. Specify the heating temperature in the Temperature field. 7. Touch Back to return to the previous screen to set the schedule for the other days. To set the preheating schedule: 1. Enter the Settings screen. 2. Touch Pre-Heating schedule.

46 46 ZT 72x Adjustment 12 Adjustment 12.1 Temperature adjustment To adjust the device, you must have the right for adjustment. To perform the temperature adjustment, use a calibrated reference thermometer. Before the device adjustment perform the Operational Qualification! Only if it fails, you have to perform the device adjustment. During the temperature adjustment procedure first the adjustment with 1 temperature is performed, then the calibration (check) with 3 temperatures. To adjust the temperature: To enter the Adjust screen: 1. Enter the Adjust screen. 1. Enter the main menu by touching in the upper left corner of the touchscreen display. 2. Touch Temperature. 2. Touch Adjust. The Adjust screen appears. 3. Enter the heating temperature for the adjustment. 4. Touch Ok. The buttons on the Adjust screen have the following functions: Button Temperature Height Restore temperature default settings Adjustment dates Function Temperature adjustment. Height adjustment. Restore of the previous temperature adjustment. Display of the adjustment dates. 5. Connect the external thermometer and put it into the water bath. Touch Ok.

47 ZT 72x Adjustment Wait until the predefined temperature is reached and stabilized. Then touch Continue. The set temperature of the first check point is shown. 9. Touch Ok. 7. Measure the real temperature with the reference thermometer and enter it. 8. Touch Ok. 10. Wait until the predefined temperature is reached and stabilized. Then touch Continue. Depending on the settings, the report will be printed out on request, automatically or not at all. More about printout settings see in 11.2 Printer settings. Then the calibration with 1, 2 or 3 temperature check points determined as OQ settings in the OQ menu follows. 11. Measure the real temperature with the reference thermometer and enter it. 12. Touch Ok. 13. Repeat the procedure (9-13) analogically for the second and third temperature points, if they are set.

48 48 ZT 72x Adjustment 12.2 Height adjustment To perform the height adjustment, use a ruler with the zero mark. Position it on the device housing below the display. During the height adjustment procedure you will be asked to measure the upper and lower position of the dipper arm and enter the values on the corresponding screens. On the Main tab you see the following data: Field Status Therm. number Date Performed by Meaning Status of the temperature adjustment Number of the reference thermometer Date and time of the temperature calibration User who performed the temperature calibration To adjust the height: 1. Enter the Adjust screen. 2. Touch Height. On the Point X tab you see the following data: Field Meaning Temperature Temperature for the calibration Int. Pt100 Temperature of the internal thermometer Ext. Pt100 Temperature of the external thermometer Real temperature Real temperature of the reference thermometer Status Status of the temperature calibration 3. Position the ruler parallel to the arm. 4. Touch Ok. 14. Touch Ok. 5. Measure and specify the upper position of the arm. 6. Touch Ok.

49 ZT 72x Adjustment 49 The arm goes down. Depending on the settings, the report will be printed out on request, automatically or not at all. More about printout settings see in 11.2 Printer settings. After the height adjustment the calibration follows. More about height calibration see in 13.4 Dipper height check. 7. Measure and specify the lower position of the arm. 8. Touch Ok. The measurement results are shown. 9. Touch Ok. 10. Measure the distance between the beaker bottom and basket bottom. Specify it in the corresponding field. 11. Touch Ok. 12. Repeat the analogical procedure for the next station (if any).

50 50 ZT 72x Adjustment 12.3 Restore of the temperature adjustment If you adjusted the temperature erroneously, you can load the previous temperature adjustment Viewing the adjustment dates To view the adjustment dates: 1. Enter the Adjust screen. To restore the temperature adjustment: 1. Enter the Adjust screen. 2. Touch Adjustment dates. 2. Touch Restore temperature default settings. 3. Touch Yes to restore the default temperature settings. The temperature and height adjustment dates are shown. 3. If needed, touch Print to receive the adjustment report. 4. Touch the Temperature field to see the temperature adjustment details. 4. Touch Ok to confirm the successfully restored default temperature settings. 5. Touch the Height field to see the height adjustment details.

51 ZT 72x Operational Qualification (OQ) Operational Qualification (OQ) To perform the Operational Qualification, you must have the right to perform OQ. To enter the OQ screen: On the Temperature adjustment screen the nominal and real temperatures, thermometer serial number, adjustment status and date, user who performed this adjustment are shown. 1. Enter the main menu by touching in the upper left corner of the touchscreen display. 2. Touch OQ. The OQ screen appears. On the Height adjustment screen the nominal and actual values for upper and lower positions of each station, adjustment status and date, user who performed this adjustment are shown. The buttons on the OQ screen have the following functions: Button Temperature Runtime Dipper speed Height Zero point PV date View OQ/PV dates OQ settings Measuring devices Function Bath temperature check. Runtime check. Dipper speed check. Dipper height check. Setting the zero point of sensors. Setting the PV date. Viewing the OQ/PV dates. Configuring the OQ settings. Setting the calibration dates and serial numbers of the measuring devices.

52 52 ZT 72x Operational Qualification (OQ) 13.1 Water bath temperature check To check the temperature, use a qualified reference thermometer. To check the temperature: 1. Enter the OQ screen. 5. Wait until the predefined temperature is reached and stabilized. Then touch Continue. 2. Touch Temperature. 3. Put the reference thermometer into the water bath. The device will ask you for 1, 2 or 3 different temperatures determined as OQ settings in the OQ menu. 6. Measure the real temperature with the reference thermometer and enter it in the corresponding field. 7. Touch Ok. 8. Repeat the procedure (6-8) analogically for the second and third temperature points, if they are set. 4. Touch Ok.

53 ZT 72x Operational Qualification (OQ) Runtime check To check the runtime, use a qualified stopwatch. On the Main tab you see the following data: To check the test runtime: 1. Enter the OQ screen. Field Status Therm. number Date Performed by Meaning Status of the temperature calibration Number of the reference thermometer Date and time of the temperature calibration User who performed the temperature calibration 2. Touch Runtime. On the Point X tab you see the following data: Field Meaning Temperature Temperature for the calibration Int. Pt100 Temperature from the internal thermometer Ext. Pt100 Temperature from the external thermometer Real temperature Real temperature from the reference thermometer Status Status of the temperature calibration 3. Specify the check runtime. 4. Touch Ok. 9. Touch Ok. Depending on the settings, the report will be printed out on request, automatically or not at all. 5. Touch Ok. More about printout settings see in 11.2 Printer settings.

54 54 ZT 72x Operational Qualification (OQ) 11. If the measurement results are not satisfactorily, touch Retry to perform the runtime check again. Depending on the settings, the report will be printed out on request, automatically or not at all. 6. Start measuring the runtime after the countdown. More about printout settings see in 11.2 Printer settings Dipper speed check To check the dipper speed, use a qualified hand held tachometer. 7. Stop the stopwatch after a beep. To check the dipper speed: 1. Enter the OQ screen. 8. Enter the actual time. 9. Touch Ok. 2. Touch Dipper speed. 3. Position the hand held tachometer to measure the dipping speed and touch Ok. The difference between the nominal and actual time is shown. It should be less than 1 second. 10. If the measurement results are satisfactorily, touch Ok.

55 ZT 72x Operational Qualification (OQ) Repeat the analogical procedure for the next station (if any). Depending on the settings, the report will be printed out on request, automatically or not at all. More about printout settings see in 11.2 Printer settings. The nominal and actual dipping speeds, station and time as well as difference between speeds (Min.-max. speed) are shown. 4. Touch Continue Dipper height check To check the dipper height, use a qualified ruler. 5. Enter the measured speed. To check the dipper height: 1. Enter the OQ screen. The nominal and actual dipping speeds, station and tachometer number as well as min.-max. speed are shown. 6. Touch Ok. 2. Touch Height. 3. Position the ruler in the beaker. 4. Touch Ok. The difference between the actual and nominal speed is shown. It should be less than 1 DPM. 7. Touch Ok.

56 56 ZT 72x Operational Qualification (OQ) Depending on the settings, the report will be printed out on request, automatically or not at all. More about printout settings see in 11.2 Printer settings Zero point check 5. Measure the actual lower position (distance between beaker bottom and basket bottom). 6. Specify this value in the corresponding field. 7. Touch Ok. To check the zero point, use qualified distance plates: Number of Switching Type glass tubes distance A 6 glass tubes ± 0.5 mm B 3 bigger glass ± 0.9 mm tubes To check the zero point: 1. Enter the OQ screen. 8. Measure the actual upper position. 9. Specify this value in the corresponding field. 10. Touch Ok. 2. Touch Zero point. 11. If the results are not satisfactorily, perform the check again by touching Retry. 12. If the results are satisfactorily, touch Ok. 13. Repeat the analogical procedure for the second station (if any). 3. Select the basket by touching the Basket number field.

57 ZT 72x Operational Qualification (OQ) Touch Ok. The device will ask you for the distance plates of three different thicknesses (0.6, 1.0 and 1.5 mm) for the basket type A and for the distance plates of 1.0 mm thickness only for the basket type B. The following procedure is for the basket type A. The distance between the cover disk bottom and the sieve is detected and shown by the device. 5. Put cover disks into the glass tubes. 11. Touch Ok. 6. Touch Ok. 12. Take the distance plates and cover disks out of the basket. 13. Touch Ok. The distance between the cover disk bottom and the sieve is detected and shown by the device. 7. Touch Ok. 8. Take out the cover disks. The measurement results are shown for each glass tube. 9. Put the 0.6 mm distance plates into the glass tubes and then the cover disks. 14. If they are not satisfactorily, touch Retry to start the zero point check for the current station from the beginning. 15. If they are satisfactorily, touch Ok. 10. Touch Ok.

58 58 ZT 72x Operational Qualification (OQ) 21. If they are not satisfactorily, touch Retry to start the zero point check for the current station from the beginning. 22. If they are satisfactorily, touch Ok. 16. Put the 1.0 mm distance plates into the glass tubes and then the cover disks. 17. Touch Ok. 23. Put the 1.5 mm distance plates into the glass tubes and then the cover disks. 24. Touch Ok. The distance between the cover disk bottom and the sieve is detected and shown by the device. 18. Touch Ok. The distance between the cover disk bottom and the sieve is detected and shown by the device. 25. Touch Ok. 19. Take the distance plates and cover disks out of the basket. 20. Touch Ok. 26. Take the distance plates and cover disks out of the basket. 27. Touch Ok. The measurement results are shown for each glass tube.

59 ZT 72x Operational Qualification (OQ) Setting the PV date Here you can enter the date of the last Performance Verification with reference tablets. To set the PV date: 1. Enter the OQ screen. The measurement results are shown for each glass tube. 28. If they are not satisfactorily, touch Retry to start the zero point check for the current station from the beginning. 29. If they are satisfactorily, touch Ok. 30. Repeat the analogical procedure for the second station (if any). The procedure for the basket type B is analogical to the procedure described above but with the distance plates of 1.0 mm thickness only. 2. Touch PV date. Depending on the settings, the report will be printed out on request, automatically or not at all. More about printout settings see in 11.2 Printer settings. 3. Specify the PV date and tablet number (batch). 4. Touch Back to return to the OQ screen.

60 60 ZT 72x Operational Qualification (OQ) 13.7 Viewing the OQ/PV dates To view the OQ/PV dates: 1. Enter the OQ screen. 2. Touch View OQ/PV dates. The temperature check points, check status, thermometer serial number, check date and user who performed this check are shown on the Temperature calibration screen. Touch Ok to return to the previous screen. The OQ/PV dates are shown. 3. If needed, print the corresponding report by touching Print. The nominal and actual time, check status, timer serial number, check date and user who performed this check are shown on the Runtime calibration screen. Touch Ok to return to the previous screen. 4. Touch each field to view the more detailed information about each check. 5. Touch Ok to return to the OQ screen. The green digits on the View OQ/PV dates screen mean that the corresponding calibration was performed successfully, black the calibration was not performed and red the calibration has failed.

61 ZT 72x Operational Qualification (OQ) 61 The nominal and actual speeds for each station, difference between the speeds, check status, tachometer serial number, check date and user who performed this check are shown on the Speed calibration screen. The distance plates, check date and user who performed this check are shown on the Zero point calibration screen. Touch Ok to return to the previous screen. Touch Ok to return to the previous screen. The lower and upper positions for each station, hub height, check status and date, user who performed this check are shown on the Height calibration screen. The PV date, tablet name and user who entered the PV date are shown on the PV Date screen. Touch Back to return to the previous screen. Touch Ok to return to the previous screen.

62 62 ZT 72x Operational Qualification (OQ) 13.8 Configuring the OQ settings To configure the OQ settings: 1. Enter the OQ screen. 5. On the Tolerances tab of the OQ settings screen specify the allowed tolerances for the checks of temperature ( C), time (1-5 Sek.), speed (1-2 DPM), height (1-5 mm) and zero point ( mm). 2. Touch OQ settings. The values can be changed only when the Own tolerances checkbox is selected on the Main tab. 3. On the Main tab of the OQ settings screen specify if to check the OQ and use the own tolerances. The days before warning about the OQ expiry and a number of zero check points can also be entered here. 6. On the Temperature tab of the OQ settings screen specify a number of check points with the temperatures for the OQ check. 7. Touch Back to return to the previous screen. 4. On the Periods tab of the OQ settings screen specify the intervals in which to perform the checks of temperature, runtime, dipping speed and height, zero point and PV.

63 ZT 72x Operational Qualification (OQ) Registering the measuring devices To register the measuring devices: 1. Enter the OQ screen. On the Time meter screen specify the serial number and the next calibration date for the applied timer. 2. Touch Measuring devices. On the Dipping speed meter screen specify the serial number and next calibration date for the applied tachometer. 3. Touch the buttons to view/specify the information about thermometer, timer, tachometer, ruler and distance plates. 4. Touch Back to return to the OQ screen. On the Height meter screen specify the serial number and the next calibration date for the applied ruler. On the Temperature meter screen specify the serial number and next calibration date for the applied thermometer.

64 64 ZT 72x Performing the Tests 14 Performing the Tests Before starting the tests ensure that the device is properly installed, connected and positioned. (See 4 Installation.) If needed, perform the adjustments/ calibrations. Prepare the product samples to be tested. On the Zero point meter screen specify the distance plates, their serial number and next calibration date. To perform the tests, you must have the right for measurement Direct measurement A direct measurement is performed with the data given before the start and not stored in the device memory. To perform a direct measurement: 1. Touch Direct measurement on the main screen. 2. Select the station to perform the test.

65 ZT 72x Performing the Tests Specify the test temperature and runtime. 4. Specify also the batch, machine (press) and basket number as well as tablet stability and information about the test. The Zero point adjustment screen shows the station number with the measured values in each glass tube. Touch Ok. By touching Ok the zero point adjustment will be performed for the current test. For more information on the zero point adjustment read 13.5 Zero point check. 8. Take out the cover disks from the basket. 5. Touch Start. 9. Put the tablets and then the cover disks into the glass tubes. 10. Touch Ok. 6. Put the cover disks into the glass tubes of the basket. A zero point adjustment follows. 7. Touch Ok. This window appears when some sensors have values deviating from the performed zero point adjustment. Touch Ok. At that the values will be set to 0 again. 11. Wait until the nominal temperature is reached and stabilized. 12. Touch Start. If you touch Auto, the test will be started automatically after reaching the nominal temperature.

66 66 ZT 72x Performing the Tests The test is started. The support arm with basket goes up and down. The test station number, temperature and runtime are shown on the display. After you have launched another station by touching the button with its number on the Test running screen, select the test type for this station and confirm it with Ok. You can also launch another station by touching the button with its number. By touching Statistics you can view the current statistical data. By touching Pause you can pause the test. At that the test station goes up so that you can check the condition of tablets visually. Touch Yes to stop the test. Touch No to continue the test. After you have touched the Statistics button on the Test running screen or after the test end, the Test statistics screen will appear. It includes the test station number, test duration, temperature and speed as well as the date and time of the test start and finish, the operator who performed the test. The disintegration times of each station are shown from the right and assessed with colors. Touch Ok to close the screen. After you have finished the test with standard baskets, confirm if the tablets disintegrated by selecting the corresponding positions. Then touch Ok.

67 ZT 72x Performing the Tests 67 Depending on the settings, the results will be exported on request, automatically or not at all. More about export settings see in 11.7 Export settings Measurement A measurement is performed with the data already stored in the device memory under products and media. To perform a measurement: 1. Touch Measurement on the main screen. Depending on the settings, the report will be printed out on request, automatically or not at all. More about printout settings see in 11.2 Printer settings. If you have no right for results, the following notification will be shown. 2. Select the station to perform the test. Ensure that the test results are printed out and touch Ok. 3. Select the test product. Specify its batch, machine (press) and basket number as well as the tablet stability and test information. 4. Touch Start.

68 68 ZT 72x Performing the Tests 5. Check the product data and touch Ok. For entering the product data see 8.1 Adding a new product. The Zero point adjustment screen shows the station number with the measured values in each glass tube. Touch Ok. By touching Ok the zero point adjustment will be performed for the current test. For more information on the zero point adjustment read 13.5 Zero point check. 8. Take out the cover disks from the basket. 6. Put the cover disks into the glass tubes of the basket. 7. Touch Ok. 9. Put the tablets and then the cover disks into the glass tubes. 10. Touch Ok. This window appears when some sensors have values deviating from the performed zero point adjustment. Touch Ok. At that the values will be set to 0 again. 11. Wait until the nominal temperature is reached and stabilized. 12. Touch Start. If you touch Auto, the test will be started automatically after reaching the nominal temperature.

69 ZT 72x Performing the Tests 69 The test is started. The support arm with basket goes up and down. The test station number, temperature and time elapsed are shown on the display. By touching Statistics you can view the current statistical data. By touching Pause you can pause the test. At that the test station goes up so that you can check the condition of tablets visually. After you have touched the Statistics button on the Test running screen or after the test end, the screen with test statistics will appear. It includes the batch number, machine (press), test duration, temperature and speed as well as the date and time of the test start and finish, the operator who performed the test. The disintegration times of each station are shown from the right and assessed with colors. Touch Ok to close this screen. Depending on the settings, the results will be exported on request, automatically or not at all. Touch Yes to stop the test. Touch No to continue the test. More about export settings see in 11.7 Export settings. Depending on the settings, the report will be printed out on request, automatically or not at all. More about printout settings see in 11.2 Printer settings. After you have launched another station by touching the button with its number on the Test running screen, select the test type for this station and confirm it with Ok.