Genesis II. revolutionise monitoring. Why Tutela Genesis II. delivering medical monitoring worldwide

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1 Genesis II revolutionise monitoring Why Tutela Genesis II Simply because Tutela Genesis II is the most complete, robust, flexible and future-proof solution to data monitoring in medical and scientific facilities. In a world where compliance is so crucial to performance, efficiency and reputation, you need the reassurance that any investment in monitoring will not only do the job, but also have scalability and longevity. Tutela Genesis II is our most evolved system yet and, being web-based, offers truly 'plug and play' installation. The system is a completely scalable monitoring solution; from a simple stand-alone monitoring system for one refrigerator, to a fully integrated multi-fixture system across multiple sites - all accessible from one secure web interface. Full compliance and audit trail Secure web - based Plug & play installation Remote alarm monitoring Remote electronic recording Flexible & scalable system delivering medical monitoring worldwide

2 Flexible and scalable integrated hardware solution Wireless Alarm Repeater Panel (WARP) The hub of the system, WARP is a discreet wall-mounted panel giving you all the information you need from your monitoring system at a glance. Displaying the data from up to 254 sensors connected via wireless transmitter modules, any deviation from any sensor in the system is flagged in red for immediate action. WARP alarm notification WARP alarm/alert sounder WARP power status WARP remote Ethernet connection Sensor text name Transmitter module battery condition Transmitter module signal strength Sensor value Normal = green Alert = amber Alarm = red Sensor probe status Alarm and Alert settings Sensor alarm/alert status Current number of pending sensor alarms/alerts Current number of active sensor alarms/alerts Signal repeater module WARP complete specification Capacity Power On-board battery backup up to 254 sensor probes V AC Up to 7hrs Review current alarm/alert status Alarm signals Display Interactivity Remote monitoring option Audit trail Local storage Connectivity Scalability Warranty Local audible and visible alarm notification. Connector for remote alarm repeater. Easy navigation via scrolling full colour LCD multifunction display. Access web-page interface from PC via local ethernet - no other network needed. Link real time sensor data to 24/7 human alarm bureau. Local settings changes and activity. Local access to historical logs - tabular and graphical. Local uploading of historical log records. 250GB HDD allows up to 60 years local storage in WARP Local T-Mesh MiWi mesh communications Ethernet Simply add more WARP s for multi site operations 24 months RTB warranty

3 Wireless transmitter modules Efficiency is improved with each wireless transmitter module able to support sensors (fully calibrated and NPL traceable) and, while most clients are looking for temperature monitoring, Tutela offers an extensive range of sensors that meet all monitoring needs. Each transmitter module is able to store data locally for up to 7 days to ensure that, even with significant power outages, full compliance can be maintained with no gaps in records. Covering a variety of applications, the Tutela System has a wireless transmitter module to satisfy every monitoring need. GENII/ AMB/200 MAP/200 FRZ/200A FRX/200B INCU/200 NTC/200 INST/200 DCT/200 CCM/200 APPLICATION COMBINED ROOM /RH MAPPING REFRIGERATOR /FREEZER LN2 CRYOGENIC COMBINED INCUBATOR /RH REFRIGERATOR /FREEZER PRESSURE C02/O2 GAS DIFFERENTIAL PRESSURE REFRIGERATOR /FREEZER DOOR CONTACT MONITOR 2 CHANNEL CLEAN CONTACT ALARM/STATUS MONITOR SENSING TYPE SHT75 SHT75 NTC 10K3A1 THERMISTOR 4-20mA SENSING RANGE 0 100% RH C C C C 0 100% RH C C VARIOUS C ACCURACY +/-1.8% RH +/-0.5 C +/-1.8% RH 0.01% FSD TRACEABILITY CALIBRATION OPTIONS POWER LIFE LOCAL MEMORY STORAGE WARRANTY Intelligent wireless signal repeater modules - creating a self healing network To ensure complete robustness within the wireless sensing network, Tutela has devised intelligent signal repeater modules. These are deployed to ensure that data signals from remote wireless sensor modules are able to seek more than just one signal path to the WARP unit. Truly self healing, the T-mesh system ensures that in the unlikely event of a node breaking down or connection going bad, there is always an alternative signal path between each sensor and the WARP. Extensive sensing options Calibrated NPL traceability Up to 7 days local storage 5 years battery life Self healing wireless network

4 Intuitive web interface User: tmdemo2 Sensor List There is a huge amount of recorded information available from a Tutela system, especially if there are multiple fixtures monitored over multiple locations. It is crucial that this information is accessible securely and quickly at a number of levels, depending on the need. Reference Description Latest Graphs Values Lo Alarm Hi Alarm Incident System 01 Ln2 Store ºc ºc System 02 Ln2 Store ºc ºc System 03 Ln2 Store % 15.0% System 04 Hi Risk Air Flow 5.4m 3.0m System 05 Hi Risk Room 22.0Pa 10.0Pa System 06 Hi Risk Prep 15.3Pa 10.0Pa System 07 Hi Risk Change 13.9Pa 8.0Pa System 08 Walk In Freezer ºc -50.0ºc System 09 Walk In Freezer ºc -50.0ºc System 10 RD ºc -35.0ºc ºc ºc 24.0% 7.0m 60.0Pa 60.0Pa 60Pa -32.0ºc -32.0ºc -10.0ºc BATT At a high level, as an overview of status, but also to be able to drill down into the detail, the intuitive web interfaces from Tutela have it covered. And being web enabled in the cloud, your data can be viewed and acted upon on any (Smart phone, tablet and laptop) device able to support a web browser anytime, anywhere in the world. System 11 RD ºc 2.0ºc 8.0ºc System 12 MFG ºc -85.0ºc -65.0ºc Tutela Systems 2013 Release Version T-Mesh self healing network If the WARP is the hub of the system, T-Mesh is the glue which holds the system together - a self healing wireless network. This is the latest Tutela development in networking, where the wireless network is able to heal itself using intelligent repeater modules so that if there is any glitch, a wireless sensor module simply finds an alternative signal path to the WARP panel. Signal Repeater Topology Key to diagrams Signal Repeater Plan View WARP module Wireless sensor transmitter module Wireless Intelligent signal repeater module Ambient sensor wireless transmitter module

5 Installation and configuration Simple installation and integration. Being entirely web-based and wireless, installation is non intrusive with minimal local IT integration or support needed. NHS clients appreciate the N3 Cloud integration out of the box. The WARP and transmitter models are all designed to be discretely wall mounted and, with the ability of the Tutela intelligent wireless repeater modules to seek the optimum signal paths, Tutela is the simply the easiest remote monitoring and alarming system to install and maintain. Configuration to suit every facility. Accessed via a connected PC A Tutela monitoring system can be configured to meet the needs of a multi fixture, multi-site organisation right down to one refrigerator. In a large system, remote alarming is normally specified, but a single refrigerator may only need a few sensors to monitor for compliance. However, there is a seamless upgrade path from the single monitored unit, to add remote alarming monitoring as well as other fixtures and departments in the organisation, should this be mandated. Only Tutela can offer this level of flexibility. Customer Ethernet Network Even within a small installation functionality is impressive. The WARP can be accessed via a PC - no further network access is needed - simply connect a laptop to the WARP via Ethernet and a simple web interface gives you full access to all sensor status, historical records and graphs. l Access via local Ethernet Expand your system VPN Tunnel VPN Tunnel Simple - add further wireless sensor units to your existing Tutela system. Customer Ethernet Network Firewall Firewall Worldwide Web Tutela Monitoring Centre To add another department or site, install another WARP module to your existing network and you then have access to the whole system via the web interface. Alarms Records Audit Trails For a full system, including remote monitoring and alarming, an internet connection is required. This will allow full system access from any device (Smart phones, tablets & laptops) anywhere in the world at anytime, giving you the peace of mind that any alarm will be notified immediately to nominated staff 24/7. Access anywhere in the world

6 Total compliance - Total peace of mind The Tutela service fully meets the exacting requirements of the FDA code which includes the use of unique electronic signatures specifically linked to fully traceable operator names. In addition, all our IT servers and databases are regulated and managed through the Company s ISO9001:2008 quality management system. FDA 21 CFR part 11 specifically regulates the secure creation, storage and management of electronic temperature records. This strict electronic signature policy is the gold standard for regulatory compliance in the field of medical monitoring systems. Through rigorous data security protocols, coupled with 24/7 global access via secure web-browser interfaces, our customers enjoy unprecedented data security, access and control of their medical monitoring processes. NHS Supply Chain Tutela Medical is now a registered supplier on the NHS Supply Chain for Medical and Scientific Refrigeration, Blood Bank and Associated Accessories, Equipment and Devices National Framework Agreement, for the supply of Temperature Monitoring and Mapping systems. For NHS customers this mean, there is no need for timeconsuming tendering and because Tutela is fully integrated with the NHS N3 Cloud, implementation is also totally seamless, and will not burden the local IT department. In fact Tutela Medical is the only wireless temperature monitoring specialist who is both N3 compliant and a registered NHS Supply Chain supplier. Coupling this level of data security with a rock-solid audit trail of sensor data and incidents, Tutela medical monitoring systems are guaranteed 100% compliant with all regulatory bodies and medical associations including MHRA, CPSA, NHS, BBTS, NBS, GMP, NHSBT and many more. job ref. genesis 6463 Remote alarm centre On top of all this, the 24/7 Tutela remote alarm monitoring centre is manned by real human beings who will call your specified staff with any deviation from norm to ensure you can take action before it becomes a compliance issue and /or serious financial loss. designed & produced by Tutela Monitoring Systems Tel: Fax: Head Office 6 Farnborough Business Centre Eelmoor Road Farnborough Hampshire GU14 7XA

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