Hamilton Arc Operating Instructions 3Hamilton Arc Operating Instructions  TABLE OF CONTENTS 1 Preface.................................................................................. 6 2 General Information............................................................. 6 2.1 Intended Use.............................................................................................................6 2.2 About this Operating Instruction...............................................................................7 3 Liability.................................................................................. 7 4 Safety Precautions and Hazards......................................... 8 4.1 General Precautions..................................................................................................8 4.2 Operation of the Arc System.....................................................................................8 4.3 Electrical Safety Precautions.....................................................................................9 4.4 Chemical, Radioactive or Biological Hazard Precautions.......................................10 5 Arc System Description......................................................10 5.1 General Information.................................................................................................10 5.2 GMP for Arc Sensors..............................................................................................13 5.2.1 ArcAir Data Modeling in GMP Environment...............................................14 5.3 ArcAir Application....................................................................................................15 5.3.1 ArcAir Application Description...................................................................17 5.4 Arc Sensor Description...........................................................................................18 5.5 CFR 21 Part 11 and Eudralex Annex 11 Compliance .............................................18 5.5.1 Audit Trail...................................................................................................19 5.5.2 Transfer Audit Trail Entries ........................................................................21 5.5.3 ArcAir Database........................................................................................22 5.5.4 ArcAir Data Modeling Software.................................................................23 6 Installation...........................................................................23 6.1 System Requirements.............................................................................................23 6.2 Unpacking Arc Sensors and Accessories...............................................................24 6.3 Configuring the Arc Sensor with ArcAir...................................................................24 6.4 Installing ArcAir Basic on the Computer..................................................................25 6.5 Configuring your Bluetooth Connection..................................................................26 6.6 Upgrade ArcAir to Advanced Version.....................................................................28 6.7 Installing ArcAir on non-Hamilton Mobiles..............................................................28 6.8 Upgrade ArcAir via In-App Purchase......................................................................29 6.9 Update ArcAir on Arc View Mobile Basic or Advanced...........................................29 6.10 Connecting an Arc Sensor to ArcAir.......................................................................30 6.11 Create User Accounts.............................................................................................31 5Hamilton Arc Operating Instructions 6.12 Create Customized User Roles...............................................................................33 6.13 Security Settings for Password and Auto Log-out..................................................33 6.14 Create Process Groups..........................................................................................35 6.15 Assign Process Groups to User Accounts..............................................................35 6.16 Configuring the Arc Sensor Parameters.................................................................36 6.17 Create Configuration Profiles..................................................................................38 6.18 Import Configuration Profiles to Arc Sensor............................................................38 6.19 Transfer and Electronically Sign Reports ...............................................................39 6.20 Electronic Signature and Report Settings...............................................................40 6.20.1 Electronic Signature Activation .................................................................40 6.20.2 Report Settings ........................................................................................41 6.21 System Language ..................................................................................................41 6.22 Install Arc Sensor in your Measuring Loop..............................................................42 6.22.1 VP 8 or M12 Pin Designation.....................................................................42 6.22.2 Electrical Connection for Analog 4-20 mA Connection.............................44 6.22.3 Controlling 4–20 mA current interface signals by pulse-width modulation (not for Incyte Arc, Dencytee Arc or CO2NTROL)...................46 6.22.4 Electrical Connection for the ECS interface (only for Visiferm RS485-ECS famlily)........................................................47 6.22.5 Validate 4-20 mA Measuring Loop............................................................49 6.22.6 Electrical Connection for the digital RS485 Interface................................49 7 Arc Sensor Operation..........................................................52 7.1 Run Experiments.....................................................................................................53 7.1.1 Create new experiment.............................................................................54 7.1.2 Edit an experiment.....................................................................................54 8 Arc Sensor Maintenance.................................................... 55 8.1 Verify Arc Sensor Status and Functionality.............................................................55 8.2 Calibration...............................................................................................................56 8.3 Product Calibration.................................................................................................57 8.4 Cleaning..................................................................................................................58 8.5 Sensor Verification..................................................................................................59 8.6 Replacing the DO Cap (only for oxygen sensors)....................................................60 8.7 Arc Sensor FW Updates incl. Accessories.............................................................61 9 Troubleshooting...................................................................62 9.1 Sensor Self-Diagnostic............................................................................................62 9.2 Warnings for DO Arc Sensors.................................................................................63 9.3 Warnings for pH / eDO / Conductivity Arc Sensors................................................64 TABLE OF CONTENTSTABLE OF CONTENTS Hamilton Warranty Please refer to the General Terms of Sales (GTS). Important note Copyright © 2022 Hamilton Bonaduz AG, Bonaduz Switzerland. All rights reserved. The reproduction of any part of this document in any form is forbidden without the express written agreement of Hamilton Bonaduz AG. Contents of this manual can be modified without previous announcement. Technical modifications reserved. Greatest possible care was used on the correctness of the information in this manual. If errors should be discovered nevertheless, Hamilton Bonaduz AG is pleased to be informed about it. Regardless of this, Hamilton Bonaduz AG cannot assume liability for any errors in this manual or for their consequences. 9.4 Warnings for Incyte Arc Sensors.............................................................................64 9.5 Warnings for Dencytee Arc Sensors.......................................................................66 9.6 Warnings for CO2NTROL Arc Sensors....................................................................67 9.7 Errors for DO Sensors.............................................................................................69 9.8 Errors for pH / ORP Arc Sensors............................................................................70 9.9 Errors for Conductivity Arc Sensors........................................................................70 9.10 Errors for Incyte Arc Sensors..................................................................................71 9.11 Errors for Dencytee Arc Sensors.............................................................................71 9.12 Errors for CO2NTROL Arc Sensors.........................................................................72 9.13 Getting Technical Support......................................................................................72 9.14 Return Back for Repair............................................................................................73 10 Disposal...............................................................................73 11 Ordering Information...........................................................74 11.1 Arc Sensors............................................................................................................74 11.2 ArcAir Software.......................................................................................................80 11.3 Arc Parts and Accessories......................................................................................81 11.4 Arc Services............................................................................................................89 7Hamilton Arc Operating Instructions Preface Liability 1 Preface Welcome to the World of Hamilton Arc System Congratulations on your purchase of Hamilton's Arc System. This technology enables the online monitoring and visualization of pH, dissolved oxygen, conductivity, carbon dioxide, cell density and ORP during biotechnological processes. A standard measuring loop consists of an Arc sensor connected directly to the process control system (PCS). With the ArcAir application, it is possible to communicate wirelessly with Arc sensors in parallel to the process control system interface when an Arc Wi Bluetooth adapter is connected between the Arc sensor and the sensor cable. Within the ArcAir application, Hamilton provides a validation functionality that offers central management functionality of users and validation reports for calibration, verification, configuration, and communication within the GMP guidelines for all Arc sensors. Those functionalities are also ready for compliance with FDA CFR 21 Part 11 and Eudralex Volume 4 Annex 11. 2 General Information 2.1 Intended Use The Arc system consist of Arc sensors, the ArcAir software application, and accessories. Arc sensors are designed to measure pH, dissolved oxygen, conductivity, carbon dioxide, cell density and ORP in a liquid medium. These measurements may be used for the control of biotechnological processes within the defined specifications (see specification sheets www.hamiltoncompany.com). The ArcAir software application and the Arc accessories are used to monitor, configure, and calibrate Arc sensors. ATTENTION! Arc sensors are not intended for hazardous atmospheres. ATTENTION! The Arc sensor has a built-in temperature sensor (NTC 22 kOhm). This temperature sensor is to be used only for monitoring the sensor conditions and not for controlling the process temperature. ATTENTION! The measurement values transmitted over wireless communication are not intended to be used for process control. 2.2 About this Operating Instruction This Operating Instruction is designed to support the integration, operation, and qualification of the Arc components. This document describes the different components of the system and how they work. The Operating Instructions describe both the hardware and software of the Arc System in a depth enabling the user to operate the Arc components. After introducing the various parts, it is shown step by step how to operate the system. After reading the Operating Instructions, users should be capable of installing and operating each component of the Arc System. The user is responsible for taking suitable precautions in the event of a product failure. Following information are highlighted within this document: ATTENTION! Essential information for avoiding personal injury or damage to the equipment. NOTE: Important instructions or interesting information. 3 Liability The liability of Hamilton Bonaduz AG is detailed in the document “General Terms and Conditions of Sale and Delivery”. Hamilton is expressly not liable for direct or indirect losses arising from the use of the products. It must in particular be insured in this conjunction that malfunctions can occur on account of the inherently limited useful life of products contingent upon their relevant applications. The user is responsible for the calibration, maintenance, and regular replacement of the products. In the case of critical product applications, Hamilton recommends using backup measuring points in order to avoid consequential damages. The user is responsible for taking suitable precautions in the event of a product failure. 9Hamilton Arc Operating Instructions Safety Precautions and Hazards Safety Precautions and Hazards 4 Safety Precautions and Hazards ATTENTION! Read the following safety instructions carefully before installing and operating the Arc System. 4.1 General Precautions For safe and correct use of Arc system, it is essential that both operating and service personnel follow the generally accepted safety procedures as well as the safety instructions given in this document, the operating instruction of the Arc System. The specification given in the specification sheets on the Hamilton website (www.hamiltoncompany.com) may under no circumstances be exceeded. Inappropriate use or misuse can be dangerous. Cleaning, assembly, and maintenance should be performed by personnel trained in such work and according to this instruction manual. When removing and cleaning the sensor, it is recommended to wear personal protective equipment (PPE) including safety goggles and protective gloves. If the system cannot be repaired by the operator, it must be sent back to Hamilton for inspection. Necessary precautions should be taken when transporting the sensors. For repair or shipment, the System should be sent back in the original reusable packaging box. Every Arc sensor sent back for repair must be decontaminated. If the conditions described in these operating instructions manual are not adhered to or if there is any inappropriate interference with the equipment, all our manufacturer’s warranties become obsolete. 4.2 Operation of the Arc System You must wear a suitable personal protective equipment (PPE), e.g., safety glasses and protective gloves when using the Arc System in a process environment, particularly when dealing with a malfunction where the risk of contamination from spilled liquids exist. Installation and maintenance of Arc sensors must be performed only by trained personnel. The mobile devices and sensors must be used for their intended applications, and in optimum safety and operational conditions. Use only wired digital or analog connection for the process control. The Arc wireless interface is designed for sensor monitoring, maintenance and service purposes. Make sure that the PG13.5 thread and the O-ring are not damaged when screwing the sensor into the process. O-rings are consumable parts which must be replaced regularly (at least once per year). Even when all required safety measures have been complied with, potential risks still exist with respect to leaks or mechanical damage to the housing. Wherever there are seals or screws, gases or liquids may leak out undetected. Always make sure that no process medium can be accidentally spilled before removing the sensor from its measurement setup. Make sure that no air or gas bubbles sticks to the sensitive part of the Arc sensor. As a consequence, the measurement value could be unstable. Do not put stress on the system by vibration, bending or torsion. Before use, verify that the sensor is properly configured for your application. Failure to observe and carry out the maintenance procedures may impair the reliability and correct functionality of the Arc system. In compliance with CFR 21 Part 11 and Eudralex Volume 4 Annex 11, if ArcAir Advanced is used to manage Arc sensors, any GMP-relevant action performed by users, such as calibration or change settings, is traceable in the software audit trail. 4.3 Electrical Safety Precautions Do not connect the Arc products to a power source of any voltage beyond the range stated in the Specification Sheet (www.hamiltoncompany.com). Consequently the measurement value could be wrong. Always use original Hamilton cables for safe connection. Make sure the cable is intact and properly plugged to avoid any short circuit. Keep the Arc products away from other equipment which emits electromagnetic radio frequency fields and minimize static electricity in the immediate environment of the measuring parts. Carefully follow all the instructions in Chapter 6.21 to avoid electrical damage to the sensor. Any contact must be clean and dry before connection. ATTENTION! Switch off the power supply and unplug the connector before dismounting the Arc sensors. 11Hamilton Arc Operating Instructions Arc System Description Arc System Description 4.4 Chemical, Radioactive or Biological Hazard Precautions Selection of the appropriate safety level and implementation of the required safety measures for working with Arc products are the sole responsibility of the user. If working with hazardous liquids observe and carry out the maintenance procedures, paying particular attention to cleaning and decontamination. If the Arc sensor becomes contaminated with biohazardous, radioactive or chemical material, it should be cleaned. 5 Arc System Description 5.1 General Information Hamilton was the first supplier of intelligent sensors for process measurement. With their integrated transmitter, Arc sensors enable direct communication to the process control system via 4-20 mA standard signal or digital Modbus. Incyte Arc, Dencytee Arc, Visiferm RS485 and CO2NTROL require the Arc Wi 2G Adapter to enable 4-20 mA output. Bluetooth wireless communication with the Arc Wireless Adapters may be used for monitoring, configuration, and calibration saves time without compromising the quality of the wired connec- tion. This Bluetooth interface enables wireless data exchange with a smartphone, tablet or computer. With the integrated micro transmitter, Arc sensors provide more reliable measurement directly to the process control system. The integrated transmitter stores all relevant sensor data, including calibration and diagnostic information, thereby simplifying calibration and maintenance. Key benefits include: • No separate transmitter needed • Simple maintenance • Easy to install • Direct digital Modbus communication to the process control system • Ethernet communication via OPC UA, using the Arc Modbus OPC Converter (REF 10089359) or Arc Modbus Profinet Converter (REF 10116586) • Full online wireless option via Bluetooth for easy monitoring, configuration and calibration of up to 30 sensors • Experiments functionality with data export • Reporting and central data management of users and validation reports for calibration, verification, configuration, and communication within the GMP guidelines, including FDA CFR21 Part 11 and Eudralex Volume 4 Annex 11 • Easy integration to Profibus using our Arc Modbus Profibus Converter REF: 243555 The following illustrations show different types of Arc connection to ArcAir. There are two different modes of Arc sensor connection to ArcAir: 1) Peer-to-peer mode The Arc sensor is in an active Bluetooth or wired connection to ArcAir and all functions and information of that specific Arc sensor are available. No further connection to other Arc sensors is possible. 2) Advertiser mode Advertiser mode is a wireless broadcast mode in which multiple sensors send information wireless to PC or mobile device. Every three seconds, the following information can be read from a PC or mobile device without any active peer to peer connection to the Arc sensor: • Measured value and unit • Temperature value and unit • Sensor status The experiments use advertiser mode to record multiple sensors. ArcAir Arc USB Power Cable Arc Sensor Figure 1: Arc system wired connection to ArcAir application 13Hamilton Arc Operating Instructions Arc System Description Arc System Description 5.2 GMP for Arc Sensors Below the validation process of Arc sensors in GMP environments or laboratory: User & Sensor Configuration Sensor Calibration* Communication Validation Process Sensor Verification Create user accounts, assign them to a predefined role and upload them to mobile device Optional: Assign Arc sensors to groups and users Configure the sensor according to the requirements of the process Perform a standard calibration in defined calibration standards Ensure accuracy of measurement Test proper connection to PCS Verify signal accuracy to the PCS Verify sensor performance after process Ensure accuracy of the measurement according the process specification Configuration Report Calibration Report Communication Report Verification Report Fermentation Laboratory and Production Environment Office Environment Reports can be printed for handwritten signature and stored in paper archives All activities from mobile app and desktop software are logged in software audit trail Reports can be signed electronically and automatically saved in predefined digital archives *Not for Incyte Arc ArcAir Arc USB Power Cable Arc Wireless Converter BT Arc Wireless Adapter BTPower Supply PCS Figure 2: Arc System wireless connection to ArcAir application ArcAir on Smartphone Arc USB Power Cable PCS Arc Wireless Adapter BTPower Supply ArcAir on Tablet Figure 3: Arc System wireless connection to tablets or smartphones with ArcAir application 15Hamilton Arc Operating Instructions Arc System Description Arc System Description 5.2.1 ArcAir Data Modeling in GMP Environment The permittivity measurement represents the viable biovolume. This viable cell volume (VCV) can be directly proportional to the viable cell density (VCD) in the exponential growth phase. To have the viable cell count available online, a transformation based on the viable biovolume is possible with a linear correlation. This can change when the cells enter the stationary growth phase. One of the reasons can be, that the number of viable cells remains the same while the cells swell towards the end of their life cycle (initiation of apoptosis), which can be detected with the measuring principle of the Incyte Arc sensor and leads to an increase in permittivity. An improvement of the correlation can be achieved by using multiple frequencies and multivariate data analysis tools. ArcAir Data Modeling is Hamilton’s tool to develop a multifrequency model to improve the correlation strength of viable cell counts throughout the entire bioprocess. A ArcAir Model Data • Not GMP relevant • GMP relevant Model Data Off-line data from validated reference method ArcAir Data Modeling Software The correlation between online and offline data at the process end is not “per se” GMP relevant. The use of correlation models developed with ArcAir Data Modeling to perform online measurement of cell density during the process is GMP relevant. The correlation at the process end is performed in the ArcAir Data Modelling Software. It is the user's decision to transfer a specific model onto a sensor for routine measurement after its validation. This transfer is performed only via ArcAir. Therefore, ArcAir records the GMP relevant actions as indicated in Figure 4 electronically. B Record at least 4 batches in ArcAir Create a Model in the AADM-SW Run Model in real-time • Recording in ArcAir, on the Sensor • Collect offline samples as triplicates • Export Data from ArcAir • Import offline and online data into the ArcAir Data Modeling Software • Build a Model from 3-4 batches • Validate with the 4th batch • Create a report • Sign the report • Transfer the Model to ArcAir and Import Model on the sensor • Calculation starts when Model is switched to active GMPrelevant Figure 4: ArcAir Data Modeling Overview (A) and Procedure (B) 5.3 ArcAir Application The ArcAir application offers safe and efficient communication for monitoring, validating and management of Arc sensors and users. The application combines the cost savings and reliability of Arc sensors with the power, convenience, and portability of mobile devices. Users benefit from automated standard calibrations and configuration in the laboratory, along with product calibrations and validations in the process environment. The additional reporting functionality offers management of validation reports for calibration, verification, configuration, communication, and user profiles within the GMP regulatory requirements for all Arc sensors. ArcAir offers an overview of all the Arc sensors in your environment, through a computer, tablet and mobile phone. Two different ArcAir versions are available. The basic version offers the functions of measurement, sensor status, experiment, configuration, and firmware update. The advanced version offers the full range of functions including verification, communication validation, user management, audit trail, and reporting functionality for GMP processes. See Chapter 6.3. 17Hamilton Arc Operating Instructions Arc System Description Arc System Description NOTE: Functionality on Mobile is limited to: • Check sensor information • Configure sensors settings and profiles • Calibrate sensors (Incyte Arc not included) • Adjust process settings • Perform sensor verification (Incyte Arc not included) • Report generation (viewable in ArcAir desktop only) • Log of audit trail events (viewable in ArcAir desktop only) • Inoculate for Incyte Arc • Validate Communication • Experiment with Arc Sensors (Incyte Arc not included) NOTE: Connection of two Arc Wireless Converters BT to a computer results in an inability to recognize sensors and establish connection with any sensors. 5.3.1 ArcAir Application Description Backstage for user and passwords management, sensor groups, mobile connection, FW update, audit trail, electronic signatures etc. Logged user Number of online sensors Filter sensor list Search sensors Sensor list Search experiments Experiment list Filter function Add new experiment Dashboard Figure 5: ArcAir Software application on computer Number of online sensors Sensor panel Measuring point Temperature ArcAir mobile device panel Status symbol for sensor:  No warnings, no errors  At least one warning active  At least one error active  Offline Primary sensor measurement value and parameter name Sensor list Experiment list Computer connection Filter sensor list Search sensor Information and ArcAir licenses Figure 6: The ArcAir application on mobile 19Hamilton Arc Operating Instructions Arc System Description Arc System Description 5.4 Arc Sensor Description VP 8 Connector Sensor head with integrated transmitter Process connection PG13,5 stainless steel O-ring Sensor shaft, heat number, Ref and serial number Sensing part Figure 7: Arc Sensor 5.5 CFR 21 Part 11 and Eudralex Annex 11 Compliance Arc sensors with ArcAir Advanced (see Chapter 6.5), constitute a computerized system ready for compliance with FDA CFR 21 Part 11 and Eudralex Volume 4 Annex 11 guidance. This is valid for all the GMP relevant entries and actions performed by Arc system users as described in Chapter 5.5.1 of the present manual. 5.5.1 Audit Trail In compliance with CFR 21 Part 11 and similar EU Annex 11 recommendations, ArcAir enables the use of a secure, computer-generated, time-stamped audit trail to independently record the date and time of users entries and actions that create, modify or delete electronic records. The Audit Trail is automatically generated and can be viewed by every user, independently from the user’s roles described in Chapter 6.10. To view the ArcAir audit trail: 1) Start ArcAir on the computer. 2) Log in with user name / password. 3) Click on “Backstage” left upper corner. 4) Select “Audit Trail”. NOTE: The Audit trail can also be synced together with reports and users with the "sync all" button. ATTENTION! In order to enable complete traceability of all GMP relevant actions, no user is enabled to edit the ArcAir audit trail. Figure 8: ArcAir Audit Trail Example 21Hamilton Arc Operating Instructions Arc System Description Arc System Description In ArcAir the GMP relevant operator entries and actions are defined as “Events”. As per example in the Figure 8, each event is tracked by: • Timestamp • Event Name • User Name • Measuring Point • Information (event details) • Source (desktop or mobile) • Comments (e.g., unsuccessful validation) The complete list of the events recorded in the ArcAir Audit-trail are: GMP event’s group Event logged in Audit trail User Roles Management Adding a role Editing a role Deleting a role Create a user Edit a user User Login/Logout (manual or automatic) Creation of new user role Assign role to a user Assign a new role to a user Edit of a user role Inactivate a user Process Groups Management Create a process Edit a process Delete a process System Management Change of language Synchronization mobile-desktop Backup of database ArcAir application start or close Electronic Signature Electronic signature GMP event’s group Event logged in Audit trail Sensor management Communication validation Calibration (not for Incyte Arc) Verification Product calibration Sensor settings changes Connection and disconnection from a sensor (manual or automatic) Firmware update Importing a configuration profile Changes to “Process Settings” Changes to “Communication validation” Changes to “Information” Single-use sensors calibration data saving Report Archive Management Creation of new report Deletion of a report Specific information logged into the audit trail can be searched compiling the “Search” field identified by the magnifier lens and choosing the appropriate “Search Column” drop-down menu. NOTE: In compliance with CFR 21 Part 11/ Eudralex Volume 4 Annex 11, it is responsibility of the end-user to validate all Arc sensors, desktop computers and mobile devices intended to be used in GMP environments. System validation and maintenance should be compliant to standard computerized system lifecycle steps comprising: Design Qualification, Installation Qualification, Operation Qualification and Performance Qualification. It is also the sole responsibility of the end-user to operate Arc sensors only with validated computer, mobile devices and/or any other computerized system intended to be used for Arc sensors management. If other software tools are used (e.g PCS, HDM), the user is responsible to validate and document the changes according to their own internal procedures. 5.5.2 Transfer Audit Trail Entries User’s entries and actions performed with mobile devices are logged in the Audit Trail as soon as a synchronization between mobile and desktop is performed. 23Hamilton Arc Operating Instructions Arc System Description Installation 1) Start ArcAir advanced on the mobile device. 2) Go to “Backstage” in the computer version and select “Mobile Connection”. 3) Follow the instruction on screen to connect the computer and the mobile device. 4) Click on "Fetch Audit Trail" on bottom left corner. 5) Verify Audit Trail entries as described in Chapter 5.5.1. NOTE: It is strongly recommended to regularly synchronize the audit trail entries from all validated devices in order to ensure full traceability of GMP events. The audit trail records every time a synchronization is performed, in order to support full traceability of the regular execution of this action. 5.5.3 ArcAir Database The Arc system is a closed computerized system. All the GMP-relevant electronic records mentioned in Chapter 5.2 can be accessed only by authorized users. Such users log-in the system tough a unique combination of user-name and password as described in Chapter 6.10 and their actions are tracked in the audit trail as explained in Chapter 5.5.1. The audit trail, user’s accounts and all the others GMP relevant electronic records are saved in ArcAir SQL Lite database. The database is secured and can be accessed only through ArcAir software. After the software installation it is automatically placed in C:\ProgramData\HAMILTON\ArcAir. Administrators can manage the database by performing operations such as “database backup” or “database change” to older backups (equal to the function “database restore”). Administrators can change the path where the database is saved, as well. To access the database management: 1) Start ArcAir on the computer. 2) Log in with the Administrator username / password. 3) Click on “Backstage” left upper corner. 4) Select “Settings”. 5) Select “Database”. 6) Perform the required operations. 5.5.4 ArcAir Data Modeling Software When using the ArcAir Data Modeling Software the GMP relevant parts are tracked in ArcAir, please refer to Figure 4 for details. The GMP relevant parts are indicated in green and must be approved and released by at least one specific user. The relevant data is recorded or exported via ArcAir and has to be imported into ArcAir Data Modeling Software. Here the model is built and validated. After validation the model is defined by creation date and time as well as s checksum. This checksum works by hash and salt identification and ensures that the data was not changed between model-export from ArcAir Data Modeling onto the sensor via ArcAir. 6 Installation 6.1 System Requirements The following system requirements must be met when installing and using the ArcAir Software. Operating system PC / Notebook Windows 10, Windows 11 Mobiles - iOS 14 and 15 - Android 10, 11, 12 Supported Mobile Devices Apple: iPhone 13, iPhone X, iPad Pro, iPad mini 4 Android: Google Pixel 6, Samsung S22, Samsung Galaxy Tab Active 2, Samsung Galaxy Tab Active 3, Samsung Galaxy S9, Huawei Mate 20, Sony Experia Z2, i.safe MOBILE IS910 Installation rights Administrator Free hard disk space 1 GB Free space for data 2 GB USB port 2 Type A USB ports Minimum Display Resolution (PC / Notebook) 1280 x 768 px RAM 16 GB Bluetooth Version ≥ 5.0 (if using internal/USB Bluetooth) 25Hamilton Arc Operating Instructions Installation Installation 6.2 Unpacking Arc Sensors and Accessories 1) Carefully unpack the Arc sensor. Enclosed you will find the Arc sensor, the Declaration of Quality, the specific Instruction Manual and the material certifications. 2) Inspect the sensor for shipping damages or missing parts. Figure 9: Arc sensor delivery package (e.g., Visiferm RS485-ECS) 6.3 Configuring the Arc Sensor with ArcAir Arc sensors require application-specific configuration. Following parts are required to configure and calibrate Arc sensors: • User Interface: Arc View Mobile or ArcAir computer Software Solution • Wireless: Arc Wi Sensor Adapter BT (Ref 243460 or 243470) (Wireless option, each Arc sensor requires an Arc Wi Adapter BT) and Bluetooth adapter for the computer- (Arc Wireless Converter BT REF 243499, Arc Wireless Converter BT Advanced REF 242333 or a compatible internal or external Bluetooth chip) • Power: External Power supply with Arc USB Power Cable (Ref 243490-01 or -02) > For more details see Chapter 6.15 To configure and set up the Arc sensors at least ArcAir Basic is required. Below in this table you will find the different ArcAir licenses and their functionality: ArcAir Basic ArcAir Advanced Availability Free download from Hamilton website or App Store Update from the basic version Intended for PC/Mobile PC/Mobile Functions Measuring, Sensor Status, Experiment function, Configuration, Firmware update Basic functions plus, Verification, Communication Validation, User Management, Audit Trail, Report functionality 6.4 Installing ArcAir Basic on the Computer 1) Download the Zip file “ArcAir” from the Hamilton webpage www.hamiltoncompany.com (search for “ArcAir Software”). 2) Unpack the ZIP-File. 3) Do not plug in the Wireless Converter before the installation of ArcAir is completed. 4) Install “ArcAir” by double-clicking “ArcAir.exe” and following the instructions on the screen. NOTE: The old specific chart functionality of Incyte Arc is no longer available in ArcAir. Therefore, the measurement data from ArcAir 3.5 or older should be exported before installing 3.6, and higher. NOTE: Hamilton releases the updates of ArcAir Windows software on www.hamiltoncompany.com. The webpage directs you to download the latest released version of the software. To install it, perform the same steps described in Chapter 6.4. The install file will automatically uninstall the old release and install the new release without the need to manually uninstall the previous version. 27Hamilton Arc Operating Instructions Installation Installation 6.5 Configuring your Bluetooth Connection Note on Bluetooth connectivity Bluetooth is a short-range wireless technology standard. While a state-of-the-art technology, it too has its shortcomings. Most notably is the limited range and attenuation in metal and liquid. In a biopharma environment, both factors are heavily present. When using Bluetooth communication make sure you have a clear line of sight of the sensor (no obstacles) and where possible, be closer than 5m away from the sensor. < 5m / direct line of sight Using an Internal Bluetooth chip or standard USB BT converter Together with ArcAir 3.8.1, the ability to use 3rd party Bluetooth chips with ArcAir was introduced. This means that the Arc Wireless Converter BT REF 243499 and Arc Wireless Converter BT Advanced REF 242333 are no longer necessary to have Bluetooth (BT) communication. The use of 3rd Party chips is encouraged and enables the latest Bluetooth features to be used in conjunction with ArcAir. To use Bluetooth connection with more than 30 devices in the Bluetooth range of the computer an internal BT chip or standard USB BT adapter must be used. NOTE: While technically ArcAir will function with all BT adapters with BLE 4.1 and greater, some are better than others and are out of our control. Something as simple as the position of the ariel can severely jeopardize the performance. Please make sure that you use a trusted, tested, and high-quality BT adapter together with ArcAir. Changing from Hamilton BT adapters to an internal BT chip or standard USB BT adapter or vice-versa. 1) Open the “Backstage” menu (top left-hand corner). 2) Select “Settings”. 3) Select “Bluetooth Settings”. 4) Use the radio button to select either “Use Hamilton Arc Wireless Converter” or “Use Internal BT chip or standard USB BT converter”. 5) Restart ArcAir for changes to take effect. NOTE: The startup process with an Internal BT chip or standard USB BT converter takes longer than the Hamilton BT devices as they do not have dedicated firmware and need to be configured by ArcAir before use. Upgrading to ArcAir Advanced with an internal BT chip or standard USB BT adapter selected Upgrading to arc air advanced can be done as normal detailed in Chapter 6.6 however if you have an Arc Wireless Converter BT Advanced REF 242333, this will not automatically be detected by the system if an internal BT chip or standard USB BT adapter is configured. In this case, to Upgrade to ArcAir advanced you will need to: 1) Change the Bluetooth settings as indicated in the chapter “Changing from Hamilton BT adapters to an internal BT chip or standard USB BT adapter or vice-versa.” To “Use Hamilton Arc Wireless Converter”. 2) Upgrade with automatically take place on restart of ArcAir. 3) Change the Bluetooth settings as indicated in the chapter “Changing from Hamilton BT adapters to an internal BT chip or standard USB BT adapter or vice-versa.” To “Use Hamilton Arc Wireless Converter”. 4) ArcAir is now Advanced and will stay advanced for 180 days, after which it is necessary to perform the above procedure again. NOTE: Upgrades via mobile devices are not affected. 29Hamilton Arc Operating Instructions Installation Installation 6.6 Upgrade ArcAir to Advanced Version To upgrade ArcAir computer version, a special Arc Wireless Converter BT (Ref 242333), ArcAir Advanced Mobile device (Ref 10071113), Arc Advanced Upgrade Key, or a mobile device with an advanced version of ArcAir installed is required. Upgrade via Arc Wireless Converter BT 1) After installing ArcAir on the Computer, connect the Arc Wireless Converter BT with ArcAir Advanced license key / Arc Advanced Upgrade Key. 2) Once your computer has identified the licence key, a pop up appears with the message “Your ArcAir is upgraded successfully to Advanced”. 3) Restart ArcAir to gain access to the advanced features. Upgrade via ArcAir Mobile 1) Ensure you have ArcAir Advanced on the mobile device. 2) Click “Scan for mobile device” in the ArcAir computer version. 3) On the mobile device click on the screen icon and select the computer to establish the connection. 4) Once your computer has identified the mobile device, a pop-up appears with the message “ArcAir has been upgraded from Basic to Advanced”. Please restart the application to enable the new features. 5) Restart ArcAir. 6.7 Installing ArcAir on non-Hamilton Mobiles 1) Connect your mobile device to an AppStore with your user account. 2) Download the ArcAir from an AppStore by scanning the barcodes below or entering “ArcAir” into the search field. NOTE: In territories, such as China, the Google Play Store is not an option. ArcAir for Android is nonetheless available after downloading on those devices the Amazon Appstore as described at www.amazon.cn/androidapp. ArcAir on Amazon Appstore is available in two separated versions: basic and advanced. 6.8 Upgrade ArcAir via In-App Purchase 1) Select the symbol with three points on the right upper corner. 2) Select “Buy Advanced Version”. 3) Enter your personal AppStore or PlayStore account password. 4) Message pops up “Please restart the application to enable the new version”. 5) Restart the ArcAir software. 6.9 Update ArcAir on Arc View Mobile Basic or Advanced 1) Touch 5 times on the Arc View Mobile screen. 2) Enter the app blocker administrator password. 3) Select “Exit SureLock” (this will end SureLock and go back to the original Android home screen). 4) Touch “Exit”. 5) Uninstall the old ArcAir Advanced version. 6) In case you own a Arc View Mobile Basic (Ref 10071111), download the .apk file “ArcAir Basic” from Hamilton webpage www.hamiltoncompany.com (search for “Arc Mobile Devices”). In case you own a Arc View Mobile Advanced (Ref 10071113 or Ref 243690 for the versions before ArcAir 3.0), download the .apk file “ArcAir Advanced” from the same webpage (search for “Arc Mobile Devices”). 7) Click on the .apk file to start the installation. 8) Touch Install. 9) After installation switch on the app blocker “SureLock” by opening SureLock application. 10) Update completed 31Hamilton Arc Operating Instructions Installation Installation NOTE: On Hamilton's pre-configured mobile devices an app blocker application is installed. The App blocker administrator mode gives you access to the Android user interface of the mobile and system functionality. To access the administration mode a password is required for the application (Default Password 0000 or 1234). The Password must be changed by entering the default password, open App blocker: > Left menu > SureLock Settings > Change Password NOTE: It is possible to update Arc View Mobile Basic only with .apk file «ArcAir Basic» and Arc View Mobile Advanced only with .apk file «ArcAir Advanced». It is not possible to install the .apk file «ArcAir Advanced» on a ArcView Mobile Basic device. NOTE: ArcAir Advanced/Basic.apk works on Arc View Mobile only. NOTE: Please make sure that the app blocker is switched on after updating ArcAir Advanced/Basic. 6.10 Connecting an Arc Sensor to ArcAir 1) Connect one of the Arc sensors with the power supply, e.g., by using the Arc USB Power Cable on a standard USB 2.0 or 3.0 port (see Figure 1). 2) Switch on the mobile’s Bluetooth connection or connect a Wireless Converter BT to USB Port of your computer (only for wireless connection, see Figure 2 and Figure 3). 3) The ArcAir application recognizes and displays the connected sensors automatically. NOTE: For automatic sensor login a unique and global Operator Level S password for all Arc sensors is required. Please make sure you have added the same Operator Level S Password for all Arc sensors in the ArcAir application under Backstage/Settings/ Operator Level S Password. Otherwise, the Arc sensors are not displayed in ArcAir. 6.11 Create User Accounts ArcAir advanced allows System Administrators to create user accounts and assign them to user roles with pre-defined role rights. 1) Start the ArcAir application on the computer. 2) Log in as an administrator. 3) Click on “Backstage” left upper corner. 4) Select “User Management”. 5) Click the “Add” Button for opening the “New User” window. 6) Type in the user details and define a temporary password. 7) Click on tab “Role” and assign the user to one of the user-roles listed. If no role is chosen, the user will automatically get the role “Calibration Technician”. 8) Click on “Save all” right lower corner. 9) In compliance with Part 11 and Annex 11, the first time the new user will log-in, he/she will be requested to enter the temporary password and set his/her own personal password. ArcAir has built-in user roles with pre-defined role rights: 33Hamilton Arc Operating Instructions Installation Installation Role Name Role Rights Administrator Sensor Calibration* Database Management Security Settings Language Changes Role Management System Settings Delete Reports Mobile connection Sensor Settings Sensor Firmware Update User Management System Process Communication Validation Audit-trail Verification Electronic Report Signing Calibration Technician Sensor Calibration* Mobile connection Audit-trail Verification Electronic Report Signing Production Technician Mobile connection Communication Validation Audit-trail Verification Electronic Report Signing Quality Manager Audit-trail Electronic Report Signing *Not for Incyte Arc NOTE: First user is the administrator and all user rights are assigned as default. NOTE: User Accounts are created first on the computer. In order to apply the changes to the users on your mobile devices, one needs to transfer the user information as described at Chapter 6.15. NOTE: Initial operation of ArcAir is in «laboratory mode», as long as no user account is created. Laboratory mode does not require a login password and all features in the installed license version are enabled. 6.12 Create Customized User Roles This function allows administrators to define customized user roles. 1) Start the ArcAir application on the computer. 2) Log in as an administrator. 3) Click on “Backstage” left upper corner. 4) Select “User Roles”. 5) Click “Add Role”. 6) Enter the new role name. 7) Check the role rights to be assigned to the new role. 8) Click the save button in the right lower corner. NOTE: The standard roles of Administrator, Calibration Technician, Production Technician and Quality Manager cannot be edited or deleted in order to ensure full traceability of the OQ tests. An administrator still has the possibility to add and edit user roles according to his/her needs. In this case, a user-added role cannot be deleted as long as it is assigned at least to one user. 6.13 Security Settings for Password and Auto Log-out In compliance with the GMP guidance for computerized systems, ArcAir Advanced enables Administrators to set rules for passwords management and users log-out. Such rules include: • Password length • Password complexity 35Hamilton Arc Operating Instructions Installation Installation • Password expiration • Users automatic log-out To access the security settings: 1) Start ArcAir on the computer. 2) Log in with the Administrator username and password. 3) Click on “Backstage” left upper corner. 4) Select “Settings”. 5) Select “Security Settings”. 6) Apply the required settings. 7) Click on the button “Save” on the bottom. Figure 10: ArcAir Security Settings NOTE: As soon as an administrator changes the password settings, every user will be requested to set a new password compliant to updated rules at first log-in. 6.14 Create Process Groups This function allows sensors to be organized into Process Groups. A Process Group is used to filter the Sensor Dashboard View or to assign a group of sensors to specific ArcAir users. 1) Start the ArcAir application on the computer. 2) Log in as an administrator. 3) Click on “Backstage” left upper corner. 4) Select “Process Groups”. 5) Click the “Add” Button for opening the sensor list. 6) Enter a process group name. 7) Select the sensors for the process group. 8) Click the save button next to the sensor list. 6.15 Assign Process Groups to User Accounts Users that have been assigned one or more process groups will only be able to see and select sensors that are within the assigned process groups. In order to assign process groups to users follow the procedure below. 1) Start the ArcAir application on the computer. 2) Click on “Backstage” left upper corner. 3) Select “User Management”. 4) Double click on a user or create a new one (see Chapter 6.10) for opening the user editor. 5) Click the “Process Groups” tab within the user editor. 6) Assign process groups to the user by selecting the assigned check boxes. 7) Click “Save all”. NOTE: Arc sensors and users are linked to Arc Wi Adapter BT ID. If a sensor change is required please make sure the new Arc sensor is connected to the same Arc Wi Adapter BT again. 37Hamilton Arc Operating Instructions Installation Installation 6.16 Configuring the Arc Sensor Parameters 1) Start the ArcAir application. 2) Select the desired sensor. 3) Open the drawer “Settings” (make sure you have the “Sensor Settings” user right). 4) Configure the sensor. A description of the available settings is given below: Parameter Name Description Default Value Configuration Measuring point User can define a sensor e.g., 242111-1234 Optional name for better identification of the measuring point Measurement Unit This is the measurement’s pH: pH Required physical unit DO/CO2: %-vol ORP: mV eDO: %-vol COND: μS/cm VCD, TCD: pF/cm or mS/cm T unit This is the temperature’s °C Required physical unit Interface Settings: Parameter Name Description Default Value Configuration Interface Mode The output of the 4-20 mA 4-20mA linear Optional or ECS (VisiFerm only) interface is a function of the value of the measurement variable Measurement Define the measurement Optional variable that controls the 4-20 mA current Value at 4mA Measurement value 0%-vol, pH 1 Required, for 4mA output (example) application dependent Value at 20mA Measurement value 62.85-%vol Required, for 20mA output or pH 10 application dependent (example) Mode in event Current output mode No output Default parameter of warning in case of warnings recommended Mode in event Current output mode Continuous Default parameter of errors in case of errors Output recommended Output current Current output 3.6 mA Default parameter for warning in case of warnings recommended Output current Current output 3.6 mA Default parameter for error in case of error recommended Output current Current output in case 3.6 mA Default parameter T out of range of temperature out of limit recommended SIP/CIP Cycles Settings: Parameter Name Description Default Value Configuration SIP process User defined temperature Temp. min: 120°C Default definition range for SIP Temp. max: 130°C parameter Time: 20min recommended CIP process User defined temperature Temp. min: 80°C Default definition range for CIP Temp. max: 100°C parameter Time: 20min recommended 39Hamilton Arc Operating Instructions Installation Installation NOTE: For more information about measurement and calibration settings, please refer to the corresponding operating instructions of the individual Arc sensors. NOTE: To create a configuration report please navigate to «Settings» and «Configuration report». All data from the sensor is read out and stored in the configuration report. 6.17 Create Configuration Profiles 1) Start the ArcAir application. 2) Select the desired sensor. 3) Open settings. 4) Select configuration profile. 5) Enter a profile name. 6) Click Create. 7) Message pops up “Configuration Profile was successfully created”. 6.18 Import Configuration Profiles to Arc Sensor 1) Start the ArcAir application. 2) Select the desired sensor. 3) Open settings. 4) Select the configuration profile from the dropdown list. 5) Decide if a configuration report is required or not. 6) Message pops up “Configuration Profile was successfully imported to sensor”. ¨ NOTE: If Modbus device address has been changed the import will lead to a sensor disconnection. 6.19 Transfer and Electronically Sign Reports In compliance with GMP guidelines for electronic data management, it is possible to generate and electronically sign reports to document the Arc sensors management operations executed with ArcAir software. Such events include sensor calibration, validation, configuration, and communication validation. In order to validate and electronically sign an existing report, it is necessary to transfer it first from mobile devices to ArcAir computer version: 1) Start ArcAir advanced on the mobile device. 2) Go to “Backstage” in the computer version and select “Mobile Connection”. 3) Follow the instruction on the screen to connect the computer and the mobile device. 4) Click on “Fetch Reports” in the bottom left corner. 5) Once all reports are transferred go to “Report Archive”. 6) New reports will be displayed on top. 7) Double click or select the report to validate. 8) A new window opens showing the selected report, with the electronic signature of the user who created the report. 9) Validate that sensor data in the report are correct. 10) Go back to “Report Archive” and flag the validated report. 11) Click on “Add Approval”. 12) A new window opens automatically showing the report, with the electronic signature of the user who approved the report. 13) A copy of the signed report is automatically exported in the standard path C:\Hamilton\ArcAir\Reports If the reports are generated using only the ArcAir computer version, only the steps from 5 to 13 are needed to validate and sign them. 41Hamilton Arc Operating Instructions Installation Installation Figure 11: Report Archive View NOTE: The electronic signature of reports must be activated by a system Administrator in ArcAir Backstage Settings as described in chapter 6.18.1. If the electronic signature is not activated, the reports will be created with the space to add a handwritten signature, after printing them. NOTE: All reports (incl. audit trail data) downloaded to the ArcAir computer version will be automatically removed from the mobile device. 6.20 Electronic Signature and Report Settings 6.20.1 Electronic Signature Activation ArcAir Advanced requires Administrators to activate electronic signatures in order to use them as explained in Chapter 6.17. 1) Start ArcAir on the computer. 2) Log in with the Administrator username and password. 3) Click on “Backstage” left upper corner. 4) Select “Settings”. 5) Select “Electronic Report Signature”. 6) Flag “Electronic Report Signature”. 7) Click on the button “Save” on the bottom. 6.20.2 Report Settings ArcAir Advanced enables users to customize the reports, such as including the Company logo and information, as well as changing the path folder, where the reports are automatically copied after electronic signature approval (see Chapter 6.17). 1) Start ArcAir on the computer. 2) Log in with your username and password. 3) Click on “Backstage” left upper corner. 4) Select “Settings”. 5) Select “Report Settings”. 6) Apply the required changes. 7) Click on the button “Save” on the bottom. 6.21 System Language Administrators can change the language of the ArcAir user interface. The available languages are: English, German, French, Spanish, Italian, Chinese, Hungarian, Russian and Japanese. 1) Start ArcAir on the computer. 1) Log in with the Administrator username and password. 2) Click on “Backstage” left upper corner. 3) Select “Settings”. 4) Select “Language settings”. 5) Choose the language form the drop-down menu. 6) Click on the button “Save” on the bottom. 43Hamilton Arc Operating Instructions Installation Installation NOTE: The language change will not affect the reports, graph or exported files. They are set to be generated always in English. 6.22 Install Arc Sensor in your Measuring Loop The mechanical design of the Arc sensor is compatible with all Hamilton process housings, including FlexiFit, Retractex, RetractoFit and Hygienic Sockets. Before installing the armatures, you should test that the seal is tight and the parts are all in working order. Ensure that there is no damage to the sensor or the armature. Check whether all O-rings are in place in the appropriate grooves and are free of damage. To avoid any mechanical damage to O-rings on the assembly, they should be lightly greased. Please note that O-rings are wetted parts and grease compounds must comply with your FDA application needs. 6.22.1 VP 8 or M12 Pin Designation Always use Hamilton VP8 or M12 sensor cables for safe connections, which are available in different lengths (see Chapter 11.3). B Shield AD C E F G H Notch Figure 12: Arc sensor with VP8 double coaxial open-end cable VP Pin Function Color Double Color Data Coaxial Cable Cable A 4–20 mA interface (mA interface 2)* Coaxial core black Yellow or for VisiFerm DO the ECS interface transparent B 4–20 mA interface (mA interface 1)* Coaxial shield black Green C Power supply: +24 VDC (10 to 27 VDC) Coaxial core red Red transparent D Power supply: Ground Coaxial shield red Blue E Temperature sensor NTC 22 kOhm** White Brown for ECS mode F Temperature sensor NTC 22 kOhm Green White for ECS mode** G RS485 (A) Yellow Gray H RS485 (B) Brown Pink Shaft Sensor shaft connected to earth Green/Yellow Green/Yellow *Not for Incyte Arc, Dencytee Arc and CO2NTROL. No 4-20 mA output is possible without an Arc Wi 2G **Only for Visiferm ECS/RS-485 M12 (A coded) Pin Designation with Respect to Hamilton M12 Sensor Cable Conductor Colors: M12 Pin Function Color Description 1 +4-20 mA # 1 White 2 -4-20 mA # 1 Brown 3 +4-20 mA # 2 Green 4 -4-20 mA # 2 Yellow 5 RS485 (A) Gray Modbus RTU RS485 6 RS485 (B) Pink Modbus RTU RS485 7 GND Blue Ground 8 + 24 VDC Red Power supply: +24 VDC (7-30 VDC) (Power supply can be external; not from PCS) Housing Shield Green/Yellow Connected to the housing including the VP8 female connector. 4-20 mA two-wire interface, functions as a current sink and needs to be powered. It regulates the input current according to the sensor measurements and galvanically isolated from the power supply. 45Hamilton Arc Operating Instructions Installation Installation 6.22.2 Electrical Connection for Analog 4-20 mA Connection The 4–20 mA interface enables direct connection of the Arc sensor to a data recorder, indicator, control unit or PCS with analog I/O. The Arc sensor works as a current sink sensor and is passive. Connect the sensor according to the pin designations (see Chapter 6.21.1). The 4–20 mA interface of the Arc sensors is pre-configured with default values for the 4–20 mA range, and measurement unit. Configure the 4–20 mA interface according to your requirements for proper measurement (see Chapter 6.15). NOTE: Incyte Arc, Dencytee Arc and CO2NTROL requires an Arc Wi 2G Adapter to provide 4–20 mA signal. Examples of circuit arrangement – + Sensor PCS VP pin B Sensor power VP Pin C VP pin D + 24 VDC 0 VDC; GND2 4–20 mA regulation 4–20 mA current U (7–30 VDC) Power Supply Sensor U AnalogInput 0 VDC; GND1 Figure 13: Three-wire loop wiring diagram for the 4–20 mA interface + – Arc sensor PCS VP pin B Sensor power VP Pin C VP pin D + 24 VDC 0 VDC; GND + – input output 4–20 mA regulation + – 4–20 mA current U (7–30 VDC) Power Supply Sensor U AnalogInput 0 VDC; GND Figure 14: The safest form of wiring, using an external isolation amplifier. The figure represents 4–20 mA interface. (For detailed technical advice, please contact the technical support at Hamilton.) RS485 (A) Vcc 2 4 1 3 Arc Sensor Arc Wi 2G Adapter BT PCS mA mA 5 6RS485 (B) RS485 (A) RS485 (B) 7 8 Vcc 4-20 mA - 4-20 mA + 4-20 mA - 4-20 mA + Vcc GND + 24 VDC GND + 24 VDC Figure 15: Typical connection to PCS using the Arc Wi 2G Adapter BT. This is the safest form of wiring an Arc sensor. The Arc Wi 2G Adapter BT provides internal galvanic isolators for enhanced analog signal quality. Connection to the PCS is simplified. Connection to the process control system is simplified. enhanced analog signal quality. Connection to the process control system is simplified. 47Hamilton Arc Operating Instructions Installation Installation 6.22.3 Controlling 4–20 mA current interface signals by pulse-width modulation (not for Incyte Arc, Dencytee Arc or CO2NTROL) Hamilton Arc sensors use the method of pulse-width modulation (PWM) to adjust the DC currents of the 4–20 mA interfaces corresponding to the measured values. In principle, the pulse width (ti) of a rectangular signal with a constant frequency, the pulse duty factor (ti/T), is modulated and afterwards demodulated by a low-pass filter to generate continuous analog DC signals. The resulting value yi corresponds to the average of the PWM signal (see Figure 13 and Figure 14). The PWM-loads of the Sensors have low-pass filters which are not able to eliminate all AC fractions of the used PWM frequency of 5 kHz due to technical impossibilities. Therefore, the current signals of the 4–20 mA interfaces are still overlaid by a certain AC which should be masked by lag smearing or input filters of the current input card of the process control system (PCS). Recommended PCS settings are a sampling rate below 3.5 kHz, an averaging over more than 1 s, and the use of galvanically separated inputs to avoid oscillations. It is also possible to use mathematical functions or isolating amplifiers for signal processing filtering if necessary. For detailed technical advice about suitable isolating amplifiers, please contact Hamilton technical support. Figure 16: Progress of a rectangular signal with a period T and a pulse duration t1 for the generation of an analog signal with the value y1 Figure 17: Progress of a rectangular signal with a period T and a pulse duration t2 for the generation of an analog signal with the value y2 NOTE: The Arc sensors generates the 4-20 mA signals by pulse with modulation (PWM) which is not compatible to all PCS systems. Also a galvanic separation between the power supply and the PCS is necessary for correct sensor functionality when used in 4-20 mA setups. Figure 14 illustrates a solution for the problem. Analog interface 1 and 2 Galvanically not isolated, pulse width modulation with 5 kHz, recommended PCS settings: • Use galvanically separated inputs • Sampling rate < 3 kHz and ≠ n * 3.5 kHz • Average over > 1 s 6.22.4 Electrical Connection for the ECS interface (only for Visiferm RS485-ECS famlily) The ECS mode enables the simulation of an electrochemical sensor. Thus a VisiFerm DO sensor can be connected to classical measuring devices instead of amperometric oxygen sensors (Clark cells). Furthermore, only the power supply of the VisiFerm DO sensor is necessary. NOTE: The ECS mode is only available for VisiFerm DO ECS and not for the Arc sensors. ATTENTION! Do not apply any high voltage (max. 2 VDC) at pin B (anode)! This can result in a destruction of the sensor in ECS mode! Note: Only in 4-20 mA mode a high voltage (max. 24 VDC) may be applied in order to operate the current interface! In an electromagnetically noisy environment, it is advisable to assign the sensor’s shaft and/or VP cable shield to earth. This significantly improves noise immunity and signal quality. The NTC temperature sensor attached to the pins E and F is isolated from the integrated electronics and is used for the temperature compensation of the oxygen signal in the measuring device. 49Hamilton Arc Operating Instructions Installation Installation Usually, classic sensors are operated with a polarization voltage between anode and cathode. This polarization voltage is supplied by the measuring device. VisiFerm DO can be operated with polarization voltages usual for electrochemical sensors. The sensor is optimized for a polarization voltage of -675 mV. For adjustment to different measuring devices and/or for simulation of different amperometric sensors the current can be adjusted between 0 and 500 nA. When using the ECS interface, the pins have the following designations with respect to VP cable conductor colors: VisiFerm DO only VP Pin Color Double Coaxial Cable Cathode A Coaxial core black transparent Anode B Coaxial shield black ATTENTION: In ECS mode never connect with a potential higher as + 2 V Power supply: + 24 VDC (10 - 27 VDC), C Coaxial core red transparent max. 1000 mW Power supply: Ground D Coaxial shield red NTC 22 kOhm E White NTC 22 kOhm F Green sensor shaft (connect with the mass shield Cable shield green-yellow of the power supply) Examples of circuit arrangement Sensor VP pin A Cathode VP pin C VP pin D Power supply VP pin B Anode VP pin E Temperature VP pin F + +24 VDC 0 VDC; Ground Transmitter /BioController Figure 18: Wiring diagram for the ECS interface 6.22.5 Validate 4-20 mA Measuring Loop In this chapter, the validation of the 4-20 mA interface is described according to the process of Arc sensors in GMP environment (see also chapter 5.2). 1) Connect the Arc sensors with the power supply, e.g., by using the Arc USB Power or the power connection from the process in combination with the wireless option. 2) Select the desired sensor from the sensor list in ArcAir. 3) Open the communication validation tab and select one of the analog interfaces. 4) Define the measurement tolerance and press “Start”. 5) Select the fixed value for the 4-20 mA measuring loop. 6) Enter the current value from the process control system and press next. 7) Follow the description on the screen. 8) Continue with other communication points or generate a report. 6.22.6 Electrical Connection for the digital RS485 Interface The digital RS485 interface enables communication with Arc sensor for performing measurements, for calibrating the Arc sensor and for changing the sensor’s configuration parameters. Arc sensors are always connected to digital controlling devices as a Modbus master. To function, they require a power supply (VP 8 pins C and D, see below). The section entitled “Configuring the Arc sensor parameters” describes operation in digital mode. Additional information: The Modbus RTU communication protocol corresponds to the Modbus-IDA standard (see www.modbus.org). Arc sensors use an open register set developed by Hamilton. Additional information about the register content and structure can be found in the programmers manual under www.hamiltoncompany.com. 51Hamilton Arc Operating Instructions Installation Installation A/A' B/B' + 24 VDC Common #1 A/A' B/B' + 24 VDC Common #2 A/A' B/B' + 24 VDC Common #3 A/A' B/B' + 24 VDC Common n≤31 Master device Distributors #n 120 Ohm line termination (option) 120 Ohm line termination (option) SDA(-) SDB(+) RDA(-) RDB(+) + 24 VDC Common Figure 20: Multi-drop bus wiring for the Modbus two-wire mode. Each sensor functions as a Modbus slave. NOTE: To avoid signal reflection on the lines the use of line termination resistors (120 Ohm each) is recommended. The effect of signal reflections becomes more relevant with long cable length and/or high baud rates. NOTE: In the connection scheme shown above, each sensor must have the unique Modbus device address for proper communication. The serial Modbus connection between the RS485 port of the master and the corresponding interfaces of the sensors must be ensured according to the EIA/TIA RS485 standard. Only one sensor can communicate with the master at any time. The Modbus physical layer is described in detail with requirements on cabling and line termination in the “Modbus Serial line Protocol and Implementation Guide” www.modbus.org > Technical Resources / Modbus Specifications / Modbus Serial line Protocol and Implementation Guide. NOTE: Since all sensors are delivered with factory-default settings, each sensor must be configured for its specific application before first use (see the section entitled «Configuring Arc Sensors»). The pins for digital the RS485 interface have the following designation with respect to VP cable conductor colors: Arc sensor VP Pin Color Double Color Data Coaxial Cable Cable Power supply: +24 VDC (7 to 30 VDC), C Coaxial core Red power consumption 1 W. red transparent Power supply: Ground D Coaxial shield red Blue RS485 (A) G Yellow Gray RS485 (B) H Brown Pink Sensor shaft Shield Green/Yellow Green/Yellow In an electromagnetically noisy environment, it is advisable to connect the VP cable shield to the earth. This significantly improves noise immunity and signal quality. Example of circuit arrangement + Arc sensor VP pin C VP pin G VP pin H PCS +24 VDC 0 VDC; Ground Power supply VP pin D A B Ground RS 485 Figure 19: Wiring diagram for the RS485 interface 53Hamilton Arc Operating Instructions Arc Sensor Operation Arc Sensor Operation 7 Arc Sensor Operation ATTENTION! Only use the sensor within the specifications (www.hamiltoncompany.com). Failure to do so may lead to damages or measurement failure. 1) Remove the watering or yellow protective caps from the Arc sensor shaft, and from the VP 8 sensor head. 2) Check the O-ring on the sensor shaft. 3) Verify if the sensing material is not damaged. 4) If using a pH sensor: Check inside of pH glass membrane for unwanted air bubbles. Shaking the sensor gently will cause any bubbles to rise to the top. 5) Verify the functionality of the Arc sensor. 6) Calibrate the sensor (see Chapter 8.2). 7) Connect the sensor to the process control system (see Chapter 6.21). 8) Verify the measurement on your control system and create a communication validation report. 9) Mount the sensor to the armature or process connection (see Chapter 6.21). NOTE: No measurement is performed at a temperature higher than 85°C (optical DO) or 110°C (pH, ORP, electrochemical DO and conductivity sensors) 60ºC (cell density) to protect sensing part and enhanced the sensor lifetime. NOTE (only optical DO sensors): To ensure a correct measurement after changing the ODO Cap type (e.g., ODO Cap H0) the reference number of the ODO Cap must be configured in the Sensing Material register (see Chapter 6.15). Firmware version ODOUM042 or higher is required. 7.1 Run Experiments With the ArcAir Experiment function, up to six Arc sensors can be monitored and recorded at the same time. The data is now exported to an Excel file (.xlsx) instead of .csv. Incyte Arc can now be monitored together with other Arc sensors in one graph. The old specific chart functionality of Incyte Arc is no longer available in ArcAir. Figure 21: Experiment View NOTE: Incyte Arc must be connected via the Arc USB power cable if the mark zero or clear zero function need to be used in parallel with other Arc sensors e.g., pH. NOTE: If Incyte Arc is used via Bluetooth connection, then no other Arc sensor can be recorded in the graph. NOTE: 6 sensors can be recorded at the same time in one experiment (Windows) and 3 in the mobile version. 55Hamilton Arc Operating Instructions Arc Sensor Operation Arc Sensor Maintenance NOTE: NOTE: It is possible to create an unlimited number of experiments limited only by the hardware of your system. 7.1.1 Create new experiment 1) Click the “Add” Icon. 2) Select up to six Arc sensors for data recording and graph. 3) Set an experiment name and batch name. 4) Enable or disable data recording in the background. 5) Set an appropriate sampling time. 6) Choose the temperature reading from one of the three selected Arc sensors. 7) Define the path for the .xlsx export file. 8) Save the settings and the experiment starts automatically. 7.1.2 Edit an experiment 1) Select settings in the experiment view. 2) Adjust the settings according to your requirements. 3) Save settings. NOTE: Changing one of the Arc sensors in the experiment is not possible. Please create a new experiment, if sensor change is required. Before the experiment, ensure which measuring unit of the sensor is set and if it is correct. Changing the unit of measurement during the experiment is not possible. Restarting the experiment is necessary if the measuring unit needs to be changed. 8 Arc Sensor Maintenance Periodic maintenance routines need to be run to ensure safe and reliable operation as well as the measurement of Arc sensors and accessories. NOTE: For more information about maintenance and description of the individual sensors, please refer to the corresponding operating instructions of the individual sensors. ATTENTION! Avoid any contact of the equipment with corrosive media. 1) Connect one of the Arc sensors with the power supply, e.g., by using the Arc USB Power Cable on a standard USB port (see Figure 1). 2) Control the traffic lights in the Quick View or sensor list (see Figure 22). 3) Please refer to the troubleshooting (see Chapter 9) for the next steps if the traffic light is not green. 4) Control the quality of the sensor under Info “Quick View” or sensor if required (see Chapter 9). NOTE: The lifetime of the Arc sensors depends on the specific conditions of the application. Temperature, pressure, and chemicals used may accelerate the ageing of both the sensor electronics and sensing material. 8.1 Verify Arc Sensor Status and Functionality 1) Connect one of the Arc sensors with the power supply, e.g., by using the Arc USB Power Cable with a standard USB port (see Figure 1). 2) Control the traffic lights in the sensor list or Quick View (see Figure 22). 57Hamilton Arc Operating Instructions Arc Sensor Maintenance Arc Sensor Maintenance The sensor is performing correctly. No errors or warnings have been registered. At least a warning has been registered. Verify the sensor warnings in Sensor Status. At least an error has been registered. Verify the sensor errors in Sensor Status. Offline Figure 22: Description of the traffic lights on ArcAir 8.2 Calibration The Arc sensors provide two kinds of sensor calibration: automatic standard calibration, and product calibration. The automatic standard calibration and the product calibration may be performed using ArcAir. NOTE: Incyte Arc and Dencytee Arc do not provide user calibration functionalities. Figure 23: ArcAir Calibration Wizard with an Arc pH sensors (symbolic picture) Automatic standard Calibration Wizard The calibration points should be chosen within the measuring range of the specific application. Correct measuring parameters should be set in order to meet the process tolerances. Arc sensors can be calibrated at one or two points: oDO eDO pH ORP Conductivity CO2 Cal. Point 1 Air Air pH 7 (factory) 475 mV (factory) 1413 µS/cm (factory) Air or CO2 free environment Cal. Point 2 Zero Point Zero Point pH 4 (factory) – – CO2 Point Calibration During calibration, the sensor checks automatically the stability of the measurement and temperature signals. NOTE: For greater measurement accuracy ensure that temperature difference between calibration medium and process medium is minimal. 1) Connect one of the Arc sensors with the power supply, e.g., by using the Arc USB Power Cable on a standard USB port (see Figure 1). 2) Select the desired sensor from the sensor list. 3) Open the calibration tab. 4) Place the sensor in the calibration standard. For pH, Cond and ORP: enter the lot number or scan the barcode. 5) Click “Start” to start the calibration wizard. 6) Follow the instruction on the screen. 8.3 Product Calibration The product calibration is an in-process calibration procedure to adjust the measurement to specific process conditions. Product calibration is an additional calibration procedure to a standard calibration. In order to restore the original standard calibration curve, the product calibration can be deleted at any time by selecting the Product calibration command “cancel”. 59Hamilton Arc Operating Instructions Arc Sensor Maintenance Arc Sensor Maintenance A new standard calibration also cancels a product calibration. 1) Connect one of the Arc sensors with the power supply, e.g., by using the Arc USB Power Cable on a standard USB port (see Figure 1). 2) Select the desired sensor from the sensor list. 3) Go to “Process Settings”. 4) Click “Start” to start the product calibration wizard. 5) Follow the instruction on the screen. NOTE: Alternatively, the product calibration may be performed with a mobile device on site the measuring point. 8.4 Cleaning This chapter outlines a manual cleaning procedure for the care and maintenance of Arc sensors including a procedure for cleaning the sensing part in particular. Cleaning the DO sensor Carry out the cleaning procedure as follows: 1) Remove the sensor from the measuring setup. 2) Soak a dust-free cloth or tissue paper with water and wipe the wetted parts with it. Thoroughly rinse the wetted parts and the sensing part of the sensor with deionised water afterwards. 3) Dry the wetted parts with a clean dust-free cloth or tissue. Store the optical DO sensors in dry and dark conditions (ODO Caps are light-sensitive). 4) If the sensing part of the sensor is contaminated with oil, grease or other organic matter, soak a clean dust-free cloth with isopropyl alcohol. Rinse residual isopropyl alcohol immediately from the sensing part with deionised water and gently wipe over. 5) After cleaning always perform a new calibration before carrying out measurements (see Chapter 8.2 in the corresponding Operating Instruction Manual). ATTENTION! Cleaning, assembly and maintenance should be performed by personnel trained in such work. Do not use any abrasive tissues or cleaning materials and do not use any cleaning chemicals other than those described above. Before removing the sensor from the measuring setup, always make sure that the setup is pressure-less and cold and that no process medium can be accidentally spilled. When removing and cleaning the sensor, it is recommended to wear safety glasses and protective gloves. NOTE: pH sensor with Ceramic diaphragms only: In the event of protein contamination, immerse the sensor’s electrode for several hours in 0.4% HCl +5 g/l pepsin. If blackening of the diaphragm is noted (due to silver compounds), immerse the electrode in 0.4% HCl + 76 g/l thiourea. NOTE: To regenerate pH or ORP Arc sensors, immerse the sensor for 10 minutes in 0.1–1.0 M NaOH, then 10 minutes in 0.1–1.0 M HCl. After regeneration, place it in a storage solution for 15 minutes. Cleaning and regeneration for pH and ORP Arc sensors Immerse sensor for 10 minutes in 0.1–1.0 M NaOH, then 10 minutes in 0.1–1.0 M HCl. After regeneration, place it in a storage solution for 15 minutes. 8.5 Sensor Verification In this chapter the verification after a process is described according to the validation process of Arc sensors in GMP environment (see also Chapter 5.2). 1) Remove the sensor from the measuring setup. 2) Connect the Arc sensors with the power supply, e.g., by using the Arc USB Power or the power connection from the process in combination with the wireless option. 3) Select the desired sensor from the sensor list. 4) Open the verification tab. 5) Define the measurement tolerance criteria. 61Hamilton Arc Operating Instructions Arc Sensor Maintenance Arc Sensor Maintenance 6) Place the sensor in the calibration standard. For pH, Cond and ORP: enter the lot number or scan the barcode. 7) Select in the drop-down menu the standard. 8) Press “Verify” and follow the description on the screen. 9) Continue with other verification points or generate a verification report. Figure 24: Sensor verification process NOTE: The pH Arc sensor only allows a verification in the unit pH and not in mV. 8.6 Replacing the DO Cap (only for oxygen sensors) The exchange of DO caps can be performed very easily: 1) Unscrew the DO Cap from the shaft (see Figure 25). 2) Exchange the O-ring. 3) Screw firmly the new DO Cap onto the sensor shaft again. 4) Perform sensor calibration (see Chapter 8.2). unscrew O-ring Figure 25: Replacing the ODO Cap of the VisiFerm DO Arc sensor 8.7 Arc Sensor FW Updates incl. Accessories 1) Start the ArcAir application on the computer. 2) Go to “Backstage”. 3) Select “Firmware” and click on “Arc Sensors”, “Arc Wireless Converters” or Arc Wi Adapters. 4) Follow the instructions on the screen. Figure 26: Firmware update for Arc sensors and accessories NOTE: Make sure that the Arc sensor is not in an active Bluetooth or serial connection, when starting the FW update process. 63Hamilton Arc Operating Instructions Troubleshooting Troubleshooting 9 Troubleshooting 9.1 Sensor Self-Diagnostic Arc sensors provide a self-diagnostic functionality to detect and identify the most common sensor malfunctions. Both interfaces, analog 4-20 mA or digital Modbus, may provide warning and error messages. The analog 4-20 mA interface can be configured according to the NAMUR recommendations to indicate an abnormal event (see Chapter 6.21.2). Use ArcAir for monitoring the sensor status and for troubleshooting. The following types of messages are provided by the self-diagnosis function. The Quick View (see Figure 27) provides an overview of all sensor status information. NOTE: Errors must be addressed and corrective action is immediately necessary. NOTE: For additional information about the sensor status and the diagnostics features refer to the sensor's operation instruction manual or the programmer`s manual. Figure 27: Quick View of pH Arc sensor with an active warning NOTE: Warnings must be acknowledged. Corrective action is depending on the root cause. The warning will be displayed continuously until the corrective action is successfully completed. 9.2 Warnings for DO Arc Sensors Warning Cause / Solution DO reading below lower limit The oxygen reading is too low (DO < 0%-sat). Make a new zero-point calibration (see chapter 8.3). DO reading above upper limit The oxygen reading is too high (DO > 300 %-sat). Make a new calibration in oxygen saturated medium (see chapter 8.2). If not successful, replace the sensor cap. DO reading unstable If continuously happening, use a new cap or check the process regulation. If the problem still appears, call our Technical Support. T reading below lower limit The temperature is below the user defined measurement temperature range. If the process temperature is outside this range, the sensor will not perform DO readings. T reading above upper limit The temperature is above the user defined measurement temperature range. If the process temperature is outside this range, the sensor will not perform DO readings. Measurement not running The measurement interval is set to 0 or the measurement temperature is out of the range. DO calibration recommended Perform a calibration in order to ensure reliable measurement (see Chapter 8.2). DO last calibration not successful The last calibration failed. The sensor is using the old successful calibration values. In order to ensure reliable measurement perform a new calibration (see Chapter 8.2). DO replace sensor cap Replace the ODO Cap and calibrate the sensor cap sensor cap sensor. This warning remains active as long as the sensor quality is below 35%. Make sure that after new cap replacement the sensor reaches at least 60% cap quality. See Chapter 8.6 for replacement conditions. The quality indicator takes sensor and cap into account. 4–20 mA value below 4 mA The measurement value is below the lower limit of the 4–20 mA interface output. Reconfigure the 4–20 mA interface (see Chapter 6.21). 4–20 mA value above 20 mA The measurement value is above the upper limit of the 4–20 mA interface output. Reconfigure the 4–20 mA interface (see Chapter 6.21). 4–20 mA current set-point not met The 4–20 mA interface is not able to regulate the current requested for the current measurement value according to your 4–20 mA interface configuration. Check the 4–20 mA wiring and supply voltage (see Chapter 6.21). 65Hamilton Arc Operating Instructions Troubleshooting Troubleshooting Warning Cause / Solution Sensor supply voltage too low The sensor supply voltage is too low for the sensor to operate correctly. Ensure stable supply voltage within the sensors specifications. Sensor supply voltage too high The sensor supply voltage is too high for sensor to operate correctly. Ensure stable supply voltage within the sensors specifications. 9.3 Warnings for pH / eDO / Conductivity Arc Sensors Warning Cause / Solution Conductivity reading below lower limit The conductivity measurement is too low. Make new calibration (see Chapter 8.2). (pH/ORP/COND) calibration recommended Perform a calibration in order to ensure reliable measurement (see Chapter 8.2) (pH/ORP/COND) last calibration not successful The last calibration failed. The sensor is using the old successful calibration values. In order to ensure reliable measurement perform a new calibration (see Chapter 8.2) 9.4 Warnings for Incyte Arc Sensors Description Warning Cause Solution T reading below lower limit Temperature too low, no measurement possible The temperature is below the specified range, so no measurement of the permittivity is possible Please ensure at least 4°C temperature T reading above upper limit Temperature too high, no measurement possible The temperature is below the specified range, so no measurement of the permittivity is possible Please ensure max. 60°C temperature Recording Memory full Memory full, no further rcording possible The internal memory of the sensor is full. Please download the data (see Incyte Arc Operating Instructions, REF 10072078) Description Warning Cause Solution Out of calibration range: lower limit Conductivity too low The conductivity is below the specified range, so no measurement of the permittivity is possible. Increase conductivity (> 1 mS/cm) Out of calibration range: upper limit Conductivity too high The conductivity is above the specified range, so no measurement of the permittivity is possible. Decrease conductivity (< 80 mS/cm) SNR too high External interferences detected The permittivity measurement is disturbed by external electrical interferences. Please check your environment and ground the sensor as described in chapter 4.3 (Incyte Arc Operating Instructions, REF 10072078) Preamp overtemp (analog supply off) Ambient temperature too high, no measurment is possible Electronic overheat because of high ambient and process temperature. Please ensure temperature conditions below 50 °C. Power supply too weak (measurement off) Power too low, no measuremnt possible The supply power not sufficient Check power supply has sufficient power output (>1.5 W). With USB Power Cable, please use the provided power supply (power supply from the USB connection not sufficient) Sensor supply voltage too low Sensor supply voltage too low The supply voltage is too low Check power supply is above 21.6 VDC. With USB Power Cable, please use the provided power supply (power supply from the USB connection not sufficient) Sensor supply voltage too high Sensor supply voltage too high The supply voltage is too high Check power supply is below 26.4 VDC. The electronics are regulated down to not get damaged. FSCAN fitting poor input data (R2) Parameter fitting cannot be applied, as the input data quality is not good enough Parameter fitting cannot be applied, as the input data quality is not good enough The Cole-Cole parameter fitting cannot be calculated as the measured viable cell density values are too low. This may be the case if the sensor is in medium only, or at process start, as well as low density cultures. 67Hamilton Arc Operating Instructions Troubleshooting Troubleshooting 9.5 Warnings for Dencytee Arc Sensors Warning Cause / Corrective Action TCD reading below lower limit The TCD reading is too low. Make a new correlation. TCD reading above upper limit The TCD reading is too high. Make a new correlation. T reading below lower limit The temperature is below the user defined measurement temperature range. If outside this range, the sensor will not perform TCD readings. T reading above upper limit The temperature is above the user defined measurement temperature range. If outside this range, the sensor will not perform TCD readings. Measurement not running Causes that trigger this warning: 1) Sensor operating voltage range is not between 10-27 VDC. 2) The temperature measurement is outside the user defined temperature range. 3) The measurement is switched off via the parameter measurement interval. TCD calibration recommended Send to Hamilton Technical Support (TS) for standard calibration. Sensor supply voltage too low The sensor supply voltage is below 10V. Please check your power supply. Sensor supply voltage too high The sensor supply voltage is above 27V. Please check your power supply. Replace sensor recommended The Sensor Quality Indicator is below 40%. The quality of the sensor is sufficient for reliable measurement, but replacement of the sensor will be needed in near future 9.6 Warnings for CO2NTROL Arc Sensors Warning Cause / Corrective Action Below calibration range The value entered by the user for Zero Point (Calibration Point 1) and for CO2 Point (Calibration Point 2) is below consented calibration limits. Above calibration range The value entered by the user for Zero Point (Calibration Point 1) and for CO2 Point (Calibration Point 2) is above consented calibration limits. Temperature was too low Temperature during the calibration is below 15°C. Adjust the temperature and repeat the calibration process. Temperature was too high Temperature during the calibration is above 45°C. Adjust the temperature and repeat the calibration process. Reading too low Applied calibration standard is not consistent with the required calibration range. The S/R value measured is too low. Check the calibration standard and repeat the calibration process. Reading too high Applied calibration standard is not consistent with the required calibration range. The S/R value measured is too high. Check the calibration standard and repeat the calibration process. Drift temperature Temperature during the calibration is not stable. Stabilize the temperature and repeat the calibration process. Drift measurement The CO2 value during the calibration is not stable. Stabilize the CO2 gas-flow and repeat the calibration process. Assigned value was out of calibration range The value entered by the user for Calibration is outside the consented calibration limits. Calibration is not complete, Calibration Point 1 required The sensor requires a 2 points calibration. The CO2 point calibration (Calibration Point 2) is still required. Calibration is not complete, Calibration Point 2 required The sensor requires a 2 points calibration. The Zero point calibration (Calibration Point 1) is still required. Calibration coefficients were out of range Applied product calibration value is not consistent with the required product calibration range. The S/R value measured is out of range. Check and repeat the product calibration process. 69Hamilton Arc Operating Instructions Troubleshooting Troubleshooting Warning Cause / Corrective Action CO2 reading is below lower limit CO2 reading too low (CO2<0mbar). Re-calibration recommended. CO2 reading is above upper limit CO2 reading too high (CO2>1000mbar). Re-calibration recommended. CO2 calibration recommended CO2 reading too low (CO2<0mbar) or too high (CO2>1000mbar). Repeat the sensor calibration. Temperature reading is below lower limit The temperature is below the user defined lower limit temperature range. If the process temperature is outside this range, the sensor will not perform CO2 readings. Temperature reading is above upper limit The temperature is above the user defined upper limit temperature range. If the process temperature is outside this range, the sensor will not perform CO2 readings. Measurement is not running Applied voltage is too high or too low. Sensor operating voltage range is between 10-27VCD or the temperature measurement is outside user defined temperature range. Sensor supply voltage too low Applied voltage is too low. Sensor operating voltage range is between 10-27VDC. Sensor supply voltage too high Applied voltage is too low. Sensor operating voltage range is between 10-27VDC. IR power limit reached Light source consumes too much power. Contact the technical support. Replace sensor Quality indicator of the sensor is below 40%. The quality of the sensor is sufficient for reliable measurement, but replacement of the sensor will be needed in near future. 9.7 Errors for DO Sensors Warning Cause / Solution DO reading failure Sensor cap is missing or the sensor is broken. DO p(O2) exceeds air pressure Measured partial pressure of oxygen is higher than the air pressure set by the operator. Reconfigure the air pressure parameter (see Chapter 6.21). T sensor defective The internal temperature sensor is defect, please call our Technical Support. DO sensor cap missing The DO sensor cap has been removed. Do not immerse the sensor in a measurement solution. Mount an DO Cap and calibrate the sensor prior measurement (see Chapter 8.6). Red channel failure Measurement channel failure. Please call our Technical Support. Sensor supply voltage far too low The sensor supply voltage is below 6 V. Please check your power supply. Sensor supply voltage far too high The sensor supply voltage is above 40 V. Please check your power supply. Temperature reading far below min The measured temperature is below the operation temperature. Temperature reading far above max The measured temperature is above the operation temperature. 71Hamilton Arc Operating Instructions Troubleshooting Troubleshooting 9.8 Errors for pH / ORP Arc Sensors Warning Cause / Solution pH reading failure (this error occurs, when any other error is active) Sensor sensitive parts are broken. Glass resistance too high pH/ORP glass is ageing during the process and cleaning cycles at high temperature. Perform sensor cleaning and regeneration (see Chapter 8.4) Glass resistance too low Sensitive pH glass may crack. Replace sensor. Reference electrode resistance too high Diaphragm may be clogged. Clean and regenerate sensor (see Chapter 8.4) Reference electrode resistance too low Reference system is broken. Check against external reference. Replace sensor. Temperature sensor defective Replace sensor Sensor failure (Quality value < 15%) Replace sensor Internal communication error Communication between measuring and interface electronic failed. Replace sensor. 9.9 Errors for Conductivity Arc Sensors Warning Cause / Solution COND reading failure (this error occurs, when any other error is active) Sensor electrodes are broken Resistance 4 electrodes too high Electrodes are not in contact with liquid or are broken Resistance 4 electrodes too low Short circuit between the electrodes Resistance 2 electrodes too high Electrodes are not in contact with liquid or are broken Resistance 2 electrodes too low Short circuit between the electrodes Temperature sensor defective Replace sensor Sensor failure (Quality value < 15%) Replace sensor Internal communication error Communication between measuring and interface electronic failed. Replace sensor. 9.10 Errors for Incyte Arc Sensors Description Error Cause Solution Temperature sensor defective No temperature measurement possible Temperature measurement not possible, please contact your Hamilton Responsible Please contact your local representative. Any other error Sensor is not working as intended Please contact your local representative. 9.11 Errors for Dencytee Arc Sensors Warning Cause / Solution TCD reading failure TCD algorithm error. T sensor defective The internal temperature sensor is defective. Temperature reading far below min The measured temperature is below the operation temperature. Temperature reading far above max The measured temperature is above the operation temperature. Sensor defective Sensor is defective or Sensor Quality Indicator is below 10%. The quality of the sensor is not sufficient for reliable measurement. Sensor needs to be replaced. Dark current too low If the dark current is too low. EEPROM comm. (I2C) error Userend EEPROM communication error. Reset the sensor and try again. Internal communication (I2C) failure Userend Internal I2C communication error. Reset the sensor and try again. Internal communication failure (Frontend) No communication between Frontend and Userend Reset the sensor and try again. Stackoverflow Internal memory failure Reset the sensor and try again. 73Hamilton Arc Operating Instructions Troubleshooting Disposal 9.12 Errors for CO2NTROL Arc Sensors Warning Cause / Solution CO2 reading failure CO2 measurement failure. Contact the technical support. CO2 exceeds air pressure Sensor measures a CO2 partial pressure higher than the value set for total air pressure in sensors settings. Check the total air pressure set value or re-calibrate the sensor. If error persist, contact Hamilton Technical support. Sensor defective Sensor is defective or quality indicator of the sensor is below 10%. The quality of the sensor is not sufficient for reliable measurement. Sensor needs to be replaced. Contact Hamilton Technical Support. Temperature sensor is defective Temperature sensor defective. Sensor needs to be replaced. Contact Hamilton Technical Support. Temperature reading is far below lower limit Temperature is far below -10°C. Contact Hamilton Technical Support. Temperature reading is far above upper limit Temperature is far above 140°C. Contact Hamilton Technical Support. Internal communication error, please contact your Hamilton Responsible Contact Hamilton Technical Support. Internal communication failure front-end Contact Hamilton Technical Support. Internal communication error, please contact your Hamilton Responsible Contact Hamilton Technical Support. Internal memory failure Restart the sensor If restarting the sensor does not solve the issue, contact Hamilton Technical Support. 9.13 Getting Technical Support If a problem persists even after you have attempted to correct it, contact Hamilton`s Customer Support: Please refer to the contact information at the back of this operating instruction. In order to be able to find the root cause of errors in ArcAir faster, ArcAir saves all activities in a log file. The file is available at the following location: • Windows: C:\ProgramData\Hamilton\ArcAir\logs\ • Android: Internal Storage\Android\data\ch.hamilton.arcair2\files\logs* • Data Format: ArcAir-XXX.log (XXX = Date) * log files can not be opened on the android device itself, they can however, be copied to a Windows machine via USB and opened in Notepad If you have a complaint about ArcAir, please always send these log files along. NOTE: If the smartphone was already connected to the PC, the USB cable must be briefly disconnected and reconnected in order to obtain a current log file under Android. Otherwise, Android always delivers the file status that was current when the smartphone and PC were connected. 9.14 Return Back for Repair Before returning an Arc sensor to Hamilton for repair, contact our Customer Service (see Chapter 9.7) and request a Returned Goods Authorization (RGA) number. Do not return an Arc sensor to Hamilton without an RMA number. This number assures proper tracking of your sensor. Arc sensors that are returned without an RMA number will be sent back to the customer without being repaired. Decontaminate the Arc sensor and remove health hazards, such as radiation, hazardous chemicals, infectious agents etc. Provide a complete description of any hazardous materials that have been in contact with the sensor. 10 Disposal The design of Arc sensors optimally considers environmental compatibility. In accordance with the EC guideline 2012/19/EU Hamilton sensors that are worn out or no longer required must be sent to a dedicated collection point for electrical and electronic devices, alternatively, must be sent to Hamilton for disposal. Sensors must not be sent to an unsorted waste disposal point. 有害物質表，請參閱www.hamiltoncompany.com, 章節過程分析， 符合性聲明 75Hamilton Arc Operating Instructions Ordering Information Ordering Information 11 Ordering Information 11.1 Arc Sensors Ref Description Visiferm RS485-ECS Family 10118255-1111 VisiFerm RS485-ECS 120 H0 10118255-1121 VisiFerm RS485-ECS 120 H2 10118255-1131 VisiFerm RS485-ECS 120 H3 10118255-1141 VisiFerm RS485-ECS 120 H4 10118255-1211 VisiFerm RS485-ECS 160 H0 10118255-1221 VisiFerm RS485-ECS 160 H2 10118255-1231 VisiFerm RS485-ECS 160 H3 10118255-1241 VisiFerm RS485-ECS 160 H4 10118255-1311 VisiFerm RS485-ECS 225 H0 10118255-1321 VisiFerm RS485-ECS 225 H2 10118255-1331 VisiFerm RS485-ECS 225 H3 10118255-1341 VisiFerm RS485-ECS 225 H4 10118255-1411 VisiFerm RS485-ECS 325 H0 10118255-1421 VisiFerm RS485-ECS 325 H2 10118255-1431 VisiFerm RS485-ECS 325 H3 10118255-1441 VisiFerm RS485-ECS 325 H4 10118255-1511 VisiFerm RS485-ECS 425 H0 10118255-1521 VisiFerm RS485-ECS 425 H2 10118255-1531 VisiFerm RS485-ECS 425 H3 10118255-1541 VisiFerm RS485-ECS 425 H4 VisiTrace RS485 Family 10140043-1111 VisiTrace RS485 120 L1 10140043-1211 VisiTrace RS485 160 L1 10140043-1311 VisiTrace RS485 225 L1 10140043-1411 VisiTrace RS485 325 L1 10140043-1511 VisiTrace RS485 425 L1 Ref Description VisiFerm mA family 10070760-1111 VisiFerm mA 120 H3 10070760-1211 VisiFerm mA 160 H3 10070760-1311 VisiFerm mA 225 H3 10070760-1411 VisiFerm mA 325 H3 10070760-1511 VisiFerm mA 425 H3 10070760-1121 VisiFerm mA 120 H4 10070760-1221 VisiFerm mA 160 H4 10070760-1321 VisiFerm mA 225 H4 10070760-1421 VisiFerm mA 325 H4 10070760-1521 VisiFerm mA 425 H4 VisiTrace mA family 10068709-1111 VisiTrace mA 120 H3 10068709-1211 VisiTrace mA 160 H3 10068709-1311 VisiTrace mA 225 H3 10068709-1411 VisiTrace mA 325 H3 10068709-1511 VisiTrace mA 425 H3 EasyFerm Plus Family 238633-1313 EasyFerm Plus PHI Arc 120 238633-1323 EasyFerm Plus PHI Arc 160 238633-1333 EasyFerm Plus PHI Arc 200 238633-1343 EasyFerm Plus PHI Arc 225 238633-1353 EasyFerm Plus PHI Arc 325 238633-1373 EasyFerm Plus PHI Arc 425 238633-2313 EasyFerm Plus HB Arc 120 238633-2323 EasyFerm Plus HB Arc 160 238633-2333 EasyFerm Plus HB Arc 200 238633-2343 EasyFerm Plus HB Arc 225 238633-2353 EasyFerm Plus HB Arc 325 238633-2373 EasyFerm Plus HB Arc 425 77Hamilton Arc Operating Instructions Ordering Information Ordering Information Ref Description EasyFerm Bio Arc Family 243632-1313 EasyFerm Bio PHI Arc 120 243632-1323 EasyFerm Bio PHI Arc 160 243632-1333 EasyFerm Bio PHI Arc 200 243632-1343 EasyFerm Bio PHI Arc 225 243632-1353 EasyFerm Bio PHI Arc 325 243632-1373 EasyFerm Bio PHI Arc 425 243632-2313 EasyFerm Bio HB Arc 120 243632-2323 EasyFerm Bio HB Arc 160 243632-2333 EasyFerm Bio HB Arc 200 243632-2343 EasyFerm Bio HB Arc 225 243632-2353 EasyFerm Bio HB Arc 325 243632-2373 EasyFerm Bio HB Arc 425 Polilyte Plus Arc Family 242428-1313 Polilyte Plus H ARC 120 242428-1323 Polilyte Plus H ARC 225 242428-1333 Polilyte Plus H ARC 325 242428-1353 Polilyte Plus H ARC 425 242428-2313 Polilyte Plus HB ARC 120 242428-2323 Polilyte Plus HB ARC 225 242428-2333 Polilyte Plus HB ARC 325 242428-2353 Polilyte Plus HB ARC 425 242428-3313 Polilyte Plus HF ARC 120 242428-3323 Polilyte Plus HF ARC 225 242428-3333 Polilyte Plus HF ARC 325 242428-3353 Polilyte Plus HF ARC 425 242428-4313 Polilyte Plus PHI ARC 120 242428-4323 Polilyte Plus PHI ARC 225 242428-4333 Polilyte Plus PHI ARC 325 242428-4353 Polilyte Plus PHI ARC 425 Ref Description Conducell 4UxF Arc Family 243590-1113 Conducell 4USF Arc 120 243590-1123 Conducell 4USF Arc 225 243590-1133 Conducell 4USF Arc 325 243590-1143 Conducell 4USF Arc 425 243590-1213 Conducell 4UPtF Arc 120 243590-1223 Conducell 4UPtF Arc 225 243590-1233 Conducell 4UPtF Arc 325 243590-1243 Conducell 4UPtF Arc 425 243590-1313 Conducell 4UHF Arc 120 243590-1323 Conducell 4UHF Arc 225 243590-1333 Conducell 4UHF Arc 325 243590-1343 Conducell 4UHF Arc 425 243590-1413 Conducell 4UTF Arc 120 243590-1423 Conducell 4UTF Arc 225 243590-1433 Conducell 4UTF Arc 325 243590-1443 Conducell 4UTF Arc 425 Conducell UPW Family 243578 Conducell UPW Arc TC 1.5" 243579 Conducell UPW Arc PG13,5 ORP Arc Family 243050 EasyFerm Plus ORP Arc 120 243051 EasyFerm Plus ORP Arc 225 243052 EasyFerm Plus ORP Arc 325 243053 EasyFerm Plus ORP Arc 425 243060 Polilyte Plus ORP Arc 120 243061 Polilyte Plus ORP Arc 225 243062 Polilyte Plus ORP Arc 325 243063 Polilyte Plus ORP Arc 425 79Hamilton Arc Operating Instructions Ordering Information Ordering Information Ref Description OxyFerm DO Arc Family 243100 OxyFerm FDA Arc 120 243101 OxyFerm FDA Arc 160 243102 OxyFerm FDA Arc 225 243103 OxyFerm FDA Arc 325 243104 OxyFerm FDA Arc 425 243140-25 OxyFerm FDA Arc XL Incyte Arc 243950-0211 Incyte Arc 120 – Expert 243950-0212 Incyte Arc 220 – Expert 243950-0213 Incyte Arc 320 – Expert 243950-0214 Incyte Arc 420 – Expert CO2NTROL RS485 10087810-11 CO2NTROL RS485 120 10087810-12 CO2NTROL RS485 160 10087810-13 CO2NTROL RS485 225 10087810-14 CO2NTROL RS485 325 10087810-15 CO2NTROL RS485 425 Dencytee RS485 11064919-11 Dencytee RS485 120 11064919-12 Dencytee RS485 225 11064919-13 Dencytee RS485 325 11064919-14 Dencytee RS485 425 VisiTrace mA Family Parts Ref Description Wetted parts 10107102 ODO Cap L1 Stainless steel 1.4435, Silicone FDA approved Application: For low ppb ranges in breweries and soft drink processing. VisiFerm DO Family Parts Ref Description Wetted parts 243515 ODO Cap H0 Stainless steel 1.4435 Silicone (FDA compliant and USP Class VI) 10068400 ODO Cap H3 Stainless steel 1.4435 Silicone (FDA compliant and USP Class VI) Application: For general application in biotechnology, water treatment and monitoring as well as in breweries, wineries and soft drink processing. Ref Description Wetted parts 243505 ODO Cap H2 Stainless steel 1.4435 PTFE (USP Class VI) 10078261 ODO Cap H4 Stainless steel 1.4435 PTFE (USP Class VI) Application: For fermentation processes where sterilization in place (SIP) is performed in media containing higher amounts of lipophilic compounds. It comes with a hygienic design. 81Hamilton Arc Operating Instructions Ordering Information Ordering Information OxyFerm FDA Family Parts Ref Description 237123 OXYFERM Membrane Kit 237126 CIP Membrane Kit 237140 FDA Membrane Kit 237118 OXYLYTE Electrolyte 50 ml 237137 Optional protective cap with chain 237306 Replacement Cathode OXYFERM 11.2 ArcAir Software ArcAir Application NOTE: Can be upgraded via In-App purchase in the ArcAir application. NOTE: In territories, such as China, the Google Play Store is not an option. ArcAir for Android is nonetheless available after downloading on those devices the Amazon Appstore as described at www.amazon.cn/androidapp. ArcAir on Amazon Appstore is available in three separated versions: light, basic and advanced. 11.3 Arc Parts and Accessories Ref Product Name 243499 Arc Wireless Converter BT Description: Designed for wireless communication between ArcAir PC version and Arc Sensors. Ref Product Name 242333 Arc Wireless Converter Advanced Description: Designed for wireless communication between ArcAir and Arc Sensors. The advanced version enables ArcAir Advanced in the computer version. 83Hamilton Arc Operating Instructions Ordering Information Ordering Information Ref Product Name Length Interface 355263 Sensor Data Cable VP 8 1 m 4-20 mA/Modbus 355264 Sensor Data Cable VP 8 3 m 4-20 mA/Modbus 355265 Sensor Data Cable VP 8 5 m 4-20 mA/Modbus 355266 Sensor Data Cable VP 8 10 m 4-20 mA/Modbus 355267 Sensor Data Cable VP 8 15 m 4-20 mA/Modbus 355268 Sensor Data Cable VP 8 20 m 4-20 mA/Modbus 355217 Sensor Cable VP 8 1 m ECS mode 355218 Sensor Cable VP 8 3 m ECS mode 355219 Sensor Cable VP 8 5 m ECS mode 355220 Sensor Cable VP 8 10 m ECS mode 355221 Sensor Cable VP 8 15 m ECS mode 355222 Sensor Cable VP 8 20 m ECS mode Description: The Sensor Cable VP 8 – open end is designed for connection to a data recorder, indicator, control unit or PCS (Process Control System) with analog I/O. Ref Product Name Length 355283 Sensor Cable M12 3 m 355284 Sensor Cable M12 5 m 355285 Sensor Cable M12 10 m Description: The Sensor Cable M12 - open is designed for connection to a data recorder, indicator, control unit or PCS (Process Control System) with analog I/O. Ref Product Name Length 355288 Sensor Power Cable M12 3 m Description: This cable includes a power adapter to supply the sensor with operation power. 85Hamilton Arc Operating Instructions Ordering Information Ordering Information Ref Product Name Connection to 243490-01 Arc USB Power Cable VP 8 Arc Sensor / Arc Wi 1G Adapter BT 243490-02 Arc USB Power Cable M12 - 8 Arc Wi 2G Adapter BT 242176 Arc Sensor Cable VP 8 355339 Arc Wi 2G BT Service Cable 2m 355289 Arc Wi 2G Service Cable 2m Description: The Arc USB Power Cable provides power supply via USB port for Arc sensors and digital communication to Hamilton’s computer software for monitoring, configuration, calibration and firmware updates. Ref Product Name Connection to 355298-xx 2,5 m Power Cable VP8 / AMP Old BioController with AMP connection 355296-xx 3 m Power Cable VP8 / BNC Old BioController with BNC connection 355297-xx 1 m Power Cable VP8 / BNC Old BioController with BNC connection 355245-xx 2,5 m Power Cable VP8 / Lemo Old BioController with Lemo connection 355258-xx 4 m Power Cable VP8 / Binder Old BioController with Binder connection Power cords: 01 CH / 02 EU / 03 US / 04 UK / 05 AU/NZ Ref Product Name Materials 243575 Calibration Station PEEK material with aluminium holder Description: Specify for two point calibration with two test gases connection e.g., 20% volume and nitrogen with 5.0 purity. Ref Product Name 10076282 Junction Box Description: For connection between process and sensor open end cables. IP 68 specified. 87Hamilton Arc Operating Instructions Ordering Information Ordering Information Ref Product Name 10089359 Arc Modbus OPC Converter Description: The Arc Modbus OPC Converter transforms Modbus protocol into OPC UA. All Arc parameters are supported. The conversion script is pre-installed and developed in compliance with GAMP 5. Ref Product Name 10116586 Arc Modbus Profinet Converter Description: The Arc Modbus Profinet Converter is a 24VDC DIN rail mounted device that can power up to four Arc sensors and converts their Modbus output to Profinet. Ref Product Name 243460 Arc Wi 1G Adapter BT Description: The Arc Wi 1G Adapter BT provides the wireless communication between the Arc sensors and mobile devices via Bluetooth 4.0. Ref Product Name 243470 Arc Wi 2G Adapter BT Description: The Arc Wi 2G Adapter BT not only provides wireless communication via Bluetooth 4.0, but also simplifies analog connection of Arc sensors to the process control system (PCS). 89Hamilton Arc Operating Instructions Ordering Information Ordering Information Ref Product Name 243555 Arc Modbus Profibus Converter Description: The Arc Modbus Profibus Converter is a 24VDC DIN rail mounted device that powers up to four Arc sensors and converts their Modbus output to Profibus DP. Ref Product Name 10071111 Arc View Mobile Basic Description: The pre-configured Arc View Mobile, Hamilton`s mobile solution for monitoring measurement values, calibrating Arc sensors and configuring various parameters with the unified user interface for all Arc sensors. The Arc View Mobile is based on the Samsung Galaxy Tab Active tablet and comes pre-configured with the ArcAir basic, app blocker application, power supply cable, instruction manual and Hamilton quick guide. Ref Product Name 10071113 Arc View Mobile Advanced Description: The pre-configured Arc View Mobile, Hamilton`s mobile solution for monitoring measurement values, calibrating Arc sensors and configuring various parameters with the unified user interface for all Arc sensors. The Arc View Mobile is based on the Samsung Galaxy Tab Active tablet and comes pre-configured with the ArcAir advanced application, including features for CFR 21 Part 11 and Eudralex Volume 4 Annex 11 compliance, app blocker application, power supply cable, instruction manual and Hamilton quick guide. Ref Product Name 10071123 ArcAir Validation & Regulatory Compliance Report Description: Validation Report for the ArcAir software dedicated to GMP customers, supporting them in the qualification and validation processes, in compliance with GAMP 5 good practices for suppliers. It describes the Quality Management System of Hamilton and its involvement throughout the software lifecycle, including the innovation process, change management, risk assessment and others. It includes a chapter detailing which features enable ArcAir to be ready for compliance with FDA CFR 21 Part 11 and Eudralex Volume 4 Annex 11. 11.4 Arc Services Hamilton service engineers are available in Europe and China in order to provide customers with on-site services. Hamilton offers a wide range of services from technical support to initial operation, qualification and maintenance of the sensors. Various tailored services are offered especially for the BioPharma, ChemPharma and brewery industries. Experienced service engineers ensure an optimal and professional service. In order to find your local service support please visit: www.hamiltoncompany.com/process-analytics/support Ordering Information Overview of service offers Technical support Initial Operation/Calibration Qualification (IQ/OQ) Service packages Maintenance Training Online service Hamilton Americas & Pacific Rim 4970 Energy Way Reno, Nevada 89502 USA Tel: +1-775-858-3000 Fax: +1-775-856-7259 sales@hamiltoncompany.com Hamilton Europe, Asia & Africa Via Crusch 8 CH-7402 Bonaduz, Switzerland Tel: +41-58-610-10-10 contact.pa.ch@hamilton.ch Web: www.hamiltoncompany.com USA: 800-648-5950 Europe: +41-58-610-10-10 To find a representative in your area, please visit www.hamiltoncompany.com. © 2022 Hamilton Bonaduz AG. All rights reserved. 10071115/07 — 08/2022