Kaye RF ValProbe
Contents
1. Mesh Networking technology provides reliable real time process data Uses global 2 4 GHz RF frequencies Provides 100 data redundancy in both remote logger and base station in addition highly reliable RF network Greater than 1 year battery life in typical use using Standard AA Lithium batteries Can operate stand alone or with PC connected with data stored in RF Base Station Intuitive study set up and extensive calculations simplify the validation and reporting process Best in class data analysis tools including ability to graph and report in cycles and groups Report tool can process and create merged reports from RF ValProbe Valprobe or Validator products Versions provide temperature to 0 1 C accuracy RH to 2 RH 4 20 mA 0 to 10 V and dry contact switch inputs 2 Channel and 5 Channel Temperature logger Temperature and pressure accuracy meets requirements for ISO 17665 EN554 and EN285 sterilization requirements Easy connection to Kaye Pressure transducer which is designed for harsh environment applications such as steam sterilizers and SIP systems Can be directly connected to 1 5 in triclover flange via SmartGasket or similar gasket design SmartMesh Technology GE s mesh networking technology is proven in many harsh environment applications Its implementation in the Kaye product line allows up to 100 nodes to be connected in a seamless reliable and self forming mesh network The mesh technology permi2. format accessible only through the system software All user inputs which could impact user data for example starting a study or running a calibration are protected via secure username password logins and are all logged in the secure audit trail database Identification Required Login Request The reporting software has been enhanced to enable easy review and printing of the audit trail based on dates times and or events for example the system administrator can select to review all failed login attempts for the last 30 days There is now also notification to the user and logged entries in the audit trail if files are tampered with or deleted from within Windows Explorer Mean Kinetic Temperature The Reporting Software provides Mean Kinetic Temperature calculation to the user Mean Kinetic Temperature MKT is single calculated temperature at which the total amount of degradation over a particular period is equal to the sum of the individual degradations that would occur at various temperatures Saturated Steam Calculation Easy integration between temperature and pressure enables EN554 compliance and determination of Saturated Steam conditions _Saturation Temperature vs Measured Temperature EN554 7 E All temps within sterilization temp band Passed H Temp does not fluctuate more than 1 K Passed 120 5 Temps do not differ from each other more than 2 K Passed i i b i 17 40 0
3. separate folder and use it to report on all 3 Kaye products Validator Valprobe or RF Valprobe Reports The Kaye RF ValProbe Software includes an intuitive yet powerful reporting utility for generating Set Up Calibration Qualification Graph and Calibration Verification reports to document validation study results Reports are generated from secure data files that can only be read by the system software Upon study completion process cycles to be analyzed are defined using the intuitive system graphic feature Qualification Reports present raw process data for individual sensors statistical calculations selected during study setup and accumulated lethality for individual sensors Summary reports present study set up details and poststudy user comments along with group interval and lethality calculations as well as data for each group and cycle Use of the Summary and Group Summary Reports can greatly reduce the need to export data for manipulation in Excel Any action affecting user data can be permanently captured in a comprehensive audit trail which can be automatically stored at a network location System administrators can now have fully automated management of passwords audit trails and data files across all validation groups Validator Qualification Report Pred on 1 Ti 545 1393 a 2 613647 8669 107 s010 13527 0702 135 03 20 5373 13510 6792 100 3533 6140 6239 4077 13549 867 25 Ms 3580 4081
4. stored in the base station until the PC is next connected rca Det SmartMesh is a trademark of Dust Networks Inc Secure Data There are multiple levels of transactional and data security built into the RF ValProbe system 1 Only Kaye RF ValProbe nodes from GE Sensing are permitted to join a RF ValProbe network through the use of private keys and login registration information exchanged between the Base Station and RF ValProbe nodes at startup 2 All data transmitted on the network is protected using secure keys preventing non authorized base stations or nodes eavesdropping on the data or feeding nonauthorized data into the network 3 All data is timestamped and identified by sending the logger s serial number All data and meta data associated with a qualification study is stored in a single secure tamperproot file 4 DoS Denial of Service attacks are prevented by Message Integrity Codes Automatic Network Formation and Optimization SmartMesh networks are self forming and self optimizing Every node can discover neighbors measure RF signal strength acquire synchronization and frequency hopping information and establish best paths and links with neighbors This ability to dynamically reconfigure is dictated by RF connectivity and or network performance requirements Interference The SmartMesh technology combines frequency hopping with TDMA Time Division Multiple Access In addition th
5. 0 17 50 00 18 00 00 Equilibration Calculation w we th a ee Ua Ue Ce HG G s PE 1G t 17 34 00 17 34 10 17 34 20 17 34 30 17 34 40 Steam in Place Application The Kaye RF ValProbe system permits up to 100 distributed nodes measuring both temperature and pressure The system allows large SIP systems to be validated or re validated in single large sections without the need for repeated SIP studies The temperature sensor is a precision small diameter bendable type RTD designed to permit easy access to pipes and vessels through gaskets The temperature probe remains in place and can be fed along pipe work or placed into stainless vessels or filter bodies The high accuracy pressure transducer is designed for 121C and 134C operation and is calibration compliant to ISO 17025 at these extended temperatures It is powered externally easy to connect and simple to configurate with the RF ValProbe software Specifications Environmental Body 40 C to 60 C 0 to 95 RH non condensing e External probe 196 C to 200 C e Logger Dimensions 190 mm x 127 mm x 45 mm fo Ie one 1 75 e Base Station Dimensions 64 mm x 32 mm x 15 mm 2 51n x 1 25 in x 5 In Temperature Single Channel External Sensor e 0 1 C range 0 C to 60 C e 0 2 C range 22 C to 0 C e 0 5 C range 80 C to 22 C e 2 0 C 196 C For 2 and 5 Channel Temperature Loggers 0 1C range 80 C to 130 C RH e 2 from
6. 10 to 90 RH e 5 from 0 to 10 90 to 100 RH e 3 at 40 C 75 RH e Certificate states ICH Points Auxiliary Inputs e Contact dry e Voltage and current 0 5 FS Battery Life Varies 10 1 min sample rate 8000 hours System Documentation 1Q OQ Protocol The Installation Qualification Operational Qualification Protocol defines a set of procedures to ensure that the Kaye Validator system is properly installed and operated correctly and is adequately documented and controlled according to cGMP requirements The documents are provided in hard copy and on CD allowing users to modify the documentation to suit specific organizational requirements Updates and addenda are available through the Kaye website Services GE Sensing provides a complete range of services for the RF ValProbe product range e Onsite installation commissioning and 1Q 0Q for RF ValProbe system e Operator training and technical support e Maintenance agreements e Factory calibration e Rental services Validation Reference The Kaye Validator system is supported with Design Qualification documentation The Validation Reference Binder provides a comprehensive overview of the GE Quality Policy description of ISO 9001 implementation and support procedures and standards for the development testing and maintenance of hardware and software Quality Control documents Development procedures Quality Assurance procedures Release documents and Qualit
7. 7972 33 10573 1 Ea 3558 x 70514 675 F EKI 368 53 Nae oo NH 020 e SSD NH OR 650 14404 8656 40 tH93 1351 66013 6681 13553 S257 8296 sza 13508 ent 510 66457 849 13551 8276 6156 05 407 WIA TIZ Summary Report Data files can be merged from multiple RF ValProbe and ValProbe studies Users can add unlimited cycles separating qualification data into specific process phases and create up to 25 groups with their own calculations and graphs during reporting Edit lrou jie Boney oe See ae a A 5 Groups T Bottom Shef e a 1104 110 Sutociave 10 441A T11 Autoclave 11 4124 112 Autoclave 12 T Middle Shel 4105 105 Autoclave 05 pa cans LLcelLeL 3 gt a A powerful graphing utility within the system software greatly simplifies process analysis and reporting Sliding vertical axes enable the operator to flag and define process transition points eliminating unnecessary reporting and streamlining the review process The graph utility features increased flexibility for graph customization including specifying X and Y axis ranges background colors line styles and labeled limit lines Graph report Security Passwords and Audit Trails The Kaye RF ValProbe is specifically designed to enable compliance with FDA 21 CFR Part 11 All recorded data including calibration offsets set up parameters and administrative tasks are saved in secure encrypted tamper proof electronic records in a
8. GE Sensing amp Inspection Technologies Kaye RF ValProbe RF Thermal Validation system The Kaye RF ValProbe integrates breakthrough RF Mesh technology with well established thermal validation in situ loggers from GE Sensing The Kaye RF ValProbe system is intended for the validation and monitoring of environmental chambers and storage areas i e stability chambers freezers refrigerators warehouses etc The RF ValProbe system utilizes a 2 4 GHz RF Mesh network and multipleredundant data storage to provide ultra reliable and robust communications and storage of critical validation data Additional safeguards guarantee data integrity storage and compliance with regulatory requirements The RF ValProbe system is comprised of RF wireless loggers a base station and software The loggers provide high accuracy measurement of temperature humidity and any 4 to 20mA or O to 10 V output RF ValProbe s software enables support for 2 Channel and 5 Channel RF Temperature loggers for Validation The software provides ease of use by Incorporating features such as self configuring of the mesh network and automatic data collection Extensive graphing reporting and calculation capabilities minimize data analysis and provide regulatory compliant reports It is used for simplified real time validation of Stability Chambers Freezers Warehouses and Steam in Place Application imagination at work Features RF
9. e mesh protocol permits the system to learn about the RF environment and dynamically adjust the network parameters to best fit the current situation The network provides an accurate time reference for the whole network ensuring all loggers and the base station are time synchronized correctly Each data sample is timestamped with this network time 2 4835 GHz Coexistence with Other RF Systems The RF ValProbe complies with the IEEE 802 15 4 the preeminent RF sensor network standard Features like frequency hopping listen before you talk and channel blacklisting prevents other RF networks being affected by the RF ValProbe Software Features Historical graphing Once a study has been started user can connect his PC anytime to the base station and retrieve all the data from the base station on the real time graph to view the data that has been logged by the loggers to that point This will enable viewing historical data without having to stop the study at the base station RF Map Users can graphically view the RF Signal strength of the loggers and their connections to other loggers and basestation for stronger RF networks A background image can also be set for the RF map to position the loggers on a real floor plan The users can use this as back up documentation for looking at the position of the loggers at a later time Real time graphing calculations Real time graphing provides min max avg calculations for t
10. he RH and Temp parameters of all the loggers being plotted in the real time graph Alarming User can set low and high alarms on the real time graph to see if any loggers have crossed the limits The limits can also be labeled by the user Auto Calibration Verification RF Valprobe System enables auto calibration verification for the users when using the RF loggers GE Kaye IRTD GE Kaye Temperature baths This enables the user to select the set points and let the software run the calibration verification including loading of offsets into the loggers automatically The software will control the Kaye drywells and read the reference temperature data from a connected Kaye IRTD permitting full automatic calibration with the Kaye calibration products Providing that the users configure the communications port access to automatic calibration will be permitted Calibration is still permitted if either drywells or IRTD is not present in which case either semi automatic or manual mode calibration is used Independent Report Wizard Along with the RF ValProbe software there is an additional software program called the Kaye Report Wizard This report wizard permits the user to launch the Create Reports section independently of the Kaye product installed on the user s PC The Create Reports button of the standard software will continue to operate as in previous versions The user can decide install the Report Wizard in a
11. licone gasket Please contact factory if different probe lengths are required www gesensing com kayeproducts 920 421D 2009 General Electric Company All Rights Reserved Specifications are subject to change without notice GE is a registered trademark of General Electric Company Other company or product names mentioned in this document may be trademarks or registered trademarks of their respective companies which are not affliated with GE
12. ontact switch and 0 10V Voltage auxiliary Input Logger with Single 36 External Temperature Probe Internal RH Sensor with contact switch and 0 10V Voltage auxiliary Input Specify 1 or 3 standard lenght custom length available on request Internal Temperature and RH Logger Voltage and Contact Auxiliary Internal Temperature and RH Logger 4 20mA Current and Contact Auxiliary RF ValProbe IQ OQ Protocol RF ValProbe Validation Reference DQ Package RF ValProbe Dual Channel Logger with external 3 Temperature Probes RF ValProbe Dual Channel Logger with external 6 Temperature Probes RF ValProbe Dual Channel Logger with external L Temperature Probes RF ValProbe Five Channel Logger with external 6 Temperature Probes RF ValProbe Five Channel Logger with external 15 Temperature Probes RF ValProbe Five Channel Logge with external L Temperature Probes RF Steam in Place Application 2570 20B 2571 20B X25 72 20B X2576 X2576E K0448 M1989 RF ValProbe Logger with External 20 Bendable Temperature Probe and RH Sensor RF ValProbe with External 20 Bendable temperature Probe RH Sensor 0 10v Voltage input and Contact Closure which accomodates Kaye Pressure Transducer RF ValProbe with External 20 Bendable temperature Probe RH Sensor 4 20mA Current Input and contact closure Kaye Pressure Transducer 110V Kaye Pressure Transducer 220V Feedthru triclover clamp SmartGasket Si
13. ts nodes to communicate with the base station and each other correcting for weak RF links and automatically adjusting to dynamic RF environment e g a forklift truck driving into a warehouse blocking a signal Interference from WiFi and other existing industrial RF networks is removed due to the frequency hopping features No special knowledge or expertise is required to install or operate the Kaye RF ValProbe RF Specifications amp Certifications RF 2 4GHz SmartMesh Technology Max number wireless nodes 100 Range approx 300 ft 100m from one node to another Each node can act as a repeater RF Type Approval Certifications in US Canada EU Other countries in progress please contact factory for up to date country list Data Redundancy The RF SmartMesh Technology provides a very secure reliable transmission however there are circumstances where RF transmission is blocked either by placement of a logger of some intermittent physical or radiofrequency blocking of the signal The loggers store up to 10 000 samples per sensor permitting the operation as a data logger if RF communication is not possible e g one logger placed in a warehouse exhaust HVAC duct The logger will resume transmitting data once it is in RF communication with the base station or other logger The base station provides data storage also permitting the user to start a study then disconnect the PC Data storage permits all data collected on all loggers to be
14. y Assurance test documentation are all included Ordering Information RF Thermal Validation System dsX2558 x2570 12 x2570 18 x2570 36 2570S L xX25 1 12 x2571 18 x2571 36 X2571S L Xx2572 12 X25 72 18 X2572 36 A25 2S L X2563 X2564 X6030 X6035 X2573 3 X2573 6 X2573S L X2574 6 x2574 15 X2574S L RF ValProbe Base Station includes USB Cable PC Software and User Manual Logger with Single 12 External Temperature Probe Internal RH Sensor no auxiliary inputs Logger with Single 18 External Temperature Probe Internal RH Sensor no auxiliary inputs Logger with Single 36 External Temperature Probe Internal RH Sensor no auxiliary inputs Specify 1 or 3 standard lenght custom length available on request Logger with Single 12 External Temperature Probe Internal RH Sensor with contact switch and 4 20mA current loop auxiliary Input Logger with Single 18 External Temperature Probe Internal RH Sensor with contact switch and 4 20mA current loop auxiliary Input Logger with Single 36 External Temperature Probe Internal RH Sensor with contact switch and 4 20mA current loop auxiliary Input Specify 1 or 3 standard lenght custom length available on request Logger with Single 12 External Temperature Probe Internal RH Sensor with contact switch and 0 10V Voltage auxiliary Input Logger with Single 18 External Temperature Probe Internal RH Sensor with c
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