BIOMERIEUX PERFORMANCE SOLUTIONS Quality & Compliance Services. How will Labguard watch over your quality?

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1 BIOMERIEUX PERFORMANCE SOLUTIONS Quality & Compliance Services How will Labguard watch over your quality?

2 Labguard 3D Services EVALUATION l Pre-installation evaluation with our experts to assess the installation constraints of your infrastructure l Complete configuration of the network l Record all equipment needs in the Labguard software l Configuration of monitoring (set points, alarm thresholds...) and metrological parameters Training l Complete training on the equipment for users and administrators l Dedicated training for metrology the full range of dedicated services. biomérieux provides a full range of services made to ensure the reliability of protocols and equipment for the long term so that quality assurance can be improved. biomerieux will assist you as a partner using Qualification guidelines (IQ, OQ, PQ) biomérieux offers a qualification package for the Labguard system. Our qualification package includes the following elements: l Risk analysis with risk scenario identification. l Qualification protocol l Test sheets (for each qualification phase) l Phase conclusion sheets Metrology services biomérieux offers a full range of metrology services adapted to your needs and regulatory requirements: l Temperature reference sensor l Calibration/adjustment & characterization kit l Calibration/adjustment & characterization license l External or internal calibration & adjustments sensors l ISO accredited or traceable metrology available Service agreement l Specialists dedicated to Labguard systems l International hotline for assistance l Remote engineering, applications, software support l Contract for adjustments and preventive maintenance Please ask your biomérieux contact for more information. 2

3 METRO In today s competitive environment with increasing workloads, there is a heightened demand for cost containment, while still maintaining or improving quality. Environmental monitoring is an essential part of regulatory compliance, quality and laboratory safety. Adapted to all your specific needs, we have design a comprehensive environmental monitoring program: the Labguard 3D Solution. Designed for mobile applications Interactive alarm & memory integrated Compatible with Labguard 3D software MOBILITY Complete range of tools biomérieux quality services ISO or Traceable metrology

4 Unique innovative design High performance battery High-tech with visual alarms HARDWARE True web server Flexibility and scalability 24/7 real-time monitoring LOGY SOFTWARE

5 Hardware Hardware The innovative hardware from Labguard communicates with the user. It has universal sensor connectivity, up to 4 different inputs. The benefits of Labguard 3D Hardware are: IIIIIIIII Interactivity - multifunctional display easy to use IIIIIIIII Universal - automatic detection of sensor - until 4 inputs in the same sensor IIIIIIIII Scalable - radio & Ethernet receiver - battery, power supply & Power Over Ethernet connection IIIIIIIII Metrology - certificate embedded in the sensor 4 parameters on the same transmitter 4 differents chambers monitered on the same transmitter 3

6 Radio Transmitter IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII l No display & one input available l projected visual alarms l 3 radio frequencies available l Automatic detection of new sensors l Real time or data logging communication l Display with 2 universal inputs l All type of sensors in the same transmitter l Plug & play sensors l Alert for battery & lost communication l Simple action buttons l Lithium battery, USB or power supply l wall mounted kit l Display with 4 universal inputs l worldwide innovation Reference Radio Band 868 Mhz 915 Mhz 433 Mhz 868 Mhz 915 Mhz 433 Mhz 868 Mhz 915 Mhz 433 Mhz Power (up to) 25 mw 25 mw 10 mw 25 mw 25 mw 10 mw 25 mw 25 mw 10 mw Communication Type Radio frequency Connectivity Usb / Radio frequency Transmission Rate 9600 bps Display No Yes Yes Channel Number Connectivity M8 Male 4 Points Transmitter Dimension (HxWxD) 123 X 107 X 31 mm Weight 190 g Connectivity Lithium Battery / Usb / Sector Battery 2 Lithium Battery Li AA 3,6 V, 2600 mah Comsumption Sector 5Vdc, 1A with power supply Standby 5 µa Transmission 50 ma Battery Lifetime Until 2 years Internal Memory Around 600 Events Per Sensor Protection Index IP55 Software Compatibility All Labguard Software Pack From Fushia Version Included Lithium Battery, Wall Mount 4 Conformities DIRECTIVES STANDARDS CE FCC IC R&TTE 1999/5/CE Low Voltage 2006/95/CE EMC 2004/108/CE CFR 47 FCC EN : 2002 V STANDARDS RADIO & EMC Part 15 EN V2.4.1 STANDARDS RADIO & EMC EN : 2010 EN : 2006 RSS-Gen / RSS-210

7 Ethernet Transmitter IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII l Display with 4 universal inputs l Power Over Ethernet / USB or Power supply l projected visual alarms l Automatic detection of sensors l Real time or data logging communication l Simple action buttons l wall mounted kit Hardware Reference Type Ethernet Connectivity Ethernet/USB Communication Display Channel Transmitter Consumption Internal memory Software compatibility Included Transmission rate 10/100Mbps Interface Ethernet Connecteur RJ45 Network protocol TCP/IP Port used 5807 Yes Number 4 Connectivity M8 Male 4 Points Dimension (HxWxD) 135 x 93 x 33mm Weight 195g Connectivity Ethernet/USB/sector Power Over Ethernet Power Classe 1 (3,84W max) Around 600 events per sensor All Labguard Software Pack From Fushia Version Lithium battery, Wall mount, RJ45 3m cable Conformities DIRECTIVES STANDARDS CE FCC IC Low Voltage 2006/95/CE EMC 2004/108/CE CFR 47 FCC EN V2.4.1 STANDARDS EMC Part 15 EN : 2010 STANDARDS EMC EN : 2006 ICES 003 : 2012 Level of radio communication Name of channel Level of battery Number of channel Alarm & status Date measurement & unit 5

8 Radio Receiver IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII l Coloured visual alarms l USB or Ethernet available connection l USB - Ethernet adapters included - Power-over Ethernet l wall mounted kit Reference Radio Band 868 Mhz 915 Mhz 433 Mhz Power (up to) 25 mw 25 mw 10 mw Communication Connectivity Ethernet/USB/Radio frequence Port used 5807 Network protocol TCP/IP IP address allocation DHCP or fixed Receiver Dimension (HxWxD) 55 x 103 x 31 mm Weight 90 g Sector 5VDC, 1A with power supply & POE Consumption Power Over Ethernet Power Classe 1 (3,84W max) Connectivity Ethernet/USB Consumption 300 ma Software compatibility All Labguard Software Pack From Fushia Version Included Wall mount, RJ45 & USB 2m cable Low Tension CE (2006/95/CE) Directives CE CE CEM (2004/108/CE) Conformities R&TTE CE (1999/5/CE) Norms EN : 2010 / EN : 2006 EN : 2002 V1.4.1 / EN V2.4.1 Conformities DIRECTIVES STANDARDS CE FCC IC R&TTE 1999/5/CE Low Voltage 2006/95/CE EMC 2004/108/CE CFR 47 FCC EN : 2002 V STANDARDS RADIO & EMC Part 15 EN V2.4.1 STANDARDS RADIO & EMC EN : 2010 EN : 2006 RSS-Gen / RSS-210 6

9 Sensors IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII l Numeric sensor with unique ID l Calibration ISO available l Internal memory (3800 data) l Fully plug & play sensor l Metrology certificate inside l Large range of sensors Hardware Temperature sensor PT 100 Humidity sensor Sensor Temp Sensor PT100 Sensor Humidity Sensor Humidity Sensor Co 2 Sensor Co 2 Reference Application Temperature High Temperature Humidity & Temperature Humidity & Temperature CO 2 CO 2 Operating range -30 to +80 C -90 to +130 C 20 to 80 % HR & 0 to 100 % HR & 0 to 10% CO 2 0 to 20% CO 2 0 to 60 C -40 to +80 C -20 to +60 C -20 to +60 C Dimensions of sensor L = 45 mm L = 30 mm L = 55 mm L = 80 mm L = 100 mm L = 100 mm Diameter of sensor 10 mm 3 mm 12 mm 12 mm 18 mm 18 mm Filter N/A N/A PTFE 1µm PTFE 0,2 µm PTFE 0,2 µm PTFE 0,2 µm Length of cable 2 m 2,5 m 2 m 2 m 2 m 2 m Flat cable YES NO YES YES NO NO Size of cable 5 mm x 1,5 mm 2 mm 5 mm x 1,5 mm 5 mm x 1,5 mm 7 mm 7 mm Accuracy 1,5% of range 1,5% of range ±0,5 C ±0,5 C ±5% RH < ±2.5% RH (w/o metrology services) +2% of reading +2% of reading Resolution 0,06 C 0,01 C 0,1% RH 0,1% RH 0,1% CO 2 0,1% CO 2 Power supply N/A N/A N/A N/A* Included Included Protection index IP68 IP68 N/A IP65 IP65 IP65 Sensor differential pressure Adapter Thermocouple K Adapter input for dry contact Adapter relay for dry contact Adapter PT100 Adapter 0-10 V Adapter 0-20 ma Reference Application Differential High High IN IN/OUT pressure Temperature Temperature Signal Signal Operating range Adjustable -200 to C N/A 2 A to 30 V DC/AC -200 to 0,3 A to 230 V DC/AC +300 C 0-10 V 0-20 ma Dimensions of sensor L x W x H = 90 x 71,5 x 36 mm N/A N/A N/A N/A N/A N/A Length of cable N/A 0,3 m 2,5 m 2,5 m 0,3 m 2,5 m 2,5 m Flat cable NO YES NO NO NO NO NO Size of cable 3,8 mm 5 mm x 1,5 mm 3,8 mm 4 mm 5 mm x 1,5 mm 3,8 mm 3,8 mm Accuracy ±0,5% Pa (w/o metrology services) +1% of reading ±1 C N/A N/A ±0,5 C N/A N/A Resolution 0,01% Pa 0,05 C N/A N/A 0,01 C 0,001 0,001 Power supply Included N/A N/A N/A N/A N/A N/A Protection index IP54 N/A N/A N/A N/A N/A N/A * Power supply transmitter recommended 7

10 MobiLITY Mobiguard IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII l Radio communication l projected visual alarms & acquisition button l Alarms provided in real time to the user l Replaceable battery l Temperature or/& humidity monitoring l Waterproof 8 Mobiguard for temperature Mobiguard for temperature & humidity Reference Type Radio frequency Communication Radio Band 868 Mhz 915 Mhz 433 Mhz 868 Mhz 915 Mhz 433 Mhz Transmission rate 9600 bps Power (up to) 25mW 25mW 10mW 25mW 25mW 10mW Application Temperature Temperature / Humidity Sensors range Temperature C C Humidity N/A 20 ~ 80 %Hr Protection index IP67 N/A Material Dimension (HxWxD) 61 x 94 x 23 mm Weight 110 g Type 2 Battery Li AAA 1,5 V, 1200 ma Consumption Standby 5 µa Transmission 50 ma Battery lifetime 1 year Internal memory Around 3800 measurements Software compatibility All Labguard Software Pack From Fushia Version Included Lithium battery, Wall mount Conformities DIRECTIVES STANDARDS CE FCC IC R&TTE 1999/5/CE Low Voltage 2006/95/CE EMC 2004/108/CE CFR 47 FCC EN : 2002 V STANDARDS RADIO & EMC Part 15 EN V2.4.1 STANDARDS RADIO & EMC EN : 2010 EN : 2006 RSS-Gen / RSS-210

11 The Labguard 3D mobility range offers a secure, robust and innovative solution for continuous monitoring during transport with radio communication (Mobiguard). In response to your needs, we propose other autonomous dataloggers with an integrated USB port. The benefits of our mobility solutions are: IIIIIIIII Mobility - designed for transport datalogging MOBILITY IIIIIIIII Traceability - fully compatible with Labguard Software and Mobility Manager IIIIIIIII Compliance - calibration ISO17025 available IIIIIIIII Flexibility - no installation needed Others solutions IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII Tomkey data logger l USB key format (connected directly to a PC via its USB port) l Data display display (last measurements recorded, high alarm, low alarm) l Interchangeable lithium battery & waterproof Tomprobe data logger l Comes in a button cell format l Can be connected to a PC via a USB adapter Reference MD5301 MD30101 MD31011 MD31121 MD31020 Name Tomkey Tomprobe Tomprobe Tomclave Interface USB Application Temperature Temperature High Temperature Capsule Interface Memory (values) N/A N/A Temperature -20 C to +60 C -20 C to +85 C 0 C to +125 C N/A N/A Display YES NO NO N/A N/A Reference Name Application MD6188 Mobility Manager license Standalone availability for Labguard Mobiguard, Tomkey & Tomprobe 9

12 Software Labguard 3D software offers the most advanced monitoring, recording and alarm features for temperatures and other environmental parameters. Labguard 3D software has been designed to fulfill demanding monitoring requirements of any installations. The benefits of Labguard 3D Software are: IIIIIIIII Universal - one single web-based software license IIIIIIIII Flexible - unlimited connections for multi-site deployment IIIIIIIII Interactive - records and monitors all physical parameters IIIIIIIII Compliant - helps you meet accreditation and requirements of all major regulatory bodies (21CFR Part 11 features) Alarm notification by widget Full web - based installation Notification via 10

13 License WELCOME License EXECUTIVE License INTEGRAL Reference MD6111 MD6171 MD6179 Software Channel 40 Unlimited Unlimited User & Group Managment l l l Audit trail l l l MD6188 Mobility manager license l l l MD6109 Alert manager license l l l MD CFR Part 11 license l l l MD6181 LDAP license l l l MD6186 Modbus license l l l MD6107 Calibration license l l l MD6108 Characterization license l l l l Included l Optional l Non applicable MD6105 MASTER LABGUARD SOFTWARE CD + book jacket + mouse pad User & group management: create and manage groups within the software solution: user groups, monitored system groups, service groups within an establishment. Audit trail: monitor every action carried out within the Labguard software solution (data can then be exported in Excel or PDF format). Mobility manager license: design for transport management within the Labguard software. It can also be used to manage sample collection tours. Alert manager license: allows alarm notifications through SMS and Phone. Includes a scheduler. To be used with the GPRS modem. 21 CFR part 11 license: alows Labguard software to be compliant with FDA guidelines regarding electronic records and signature. Mandatory for pharmaceutical industries. LDAP license (Lightweight Directory Access Protocol): allows to synchronize Labguard software with customer IS user s directory, providing a «single sign on» where one password for a user is shared. User information s are automatically updated from your company/database. Modbus license: communication protocol used for Building Management System (BMS) including HVAC (Heating, Ventilation, Air Conditioning). Allow Labguard software to communicate data to the customer s BMS infrastructure. Calibration license: allow to carry out Labguard sensors calibration and adjustment. Characterization license: allow to carry out temperature characterization (mapping) of thermostatic chambers using FDX or IEC X standards, with up to 15 temperature points. 11

14 Metrology A complete range of Metrology equipment for thermostatic chambers with internal instrumentation and services is part of the Labguard 3D range. The benefits of biomérieux Metrology solutions are: IIIIIIIII biomérieux has an internal laboratory accredited by COFRAC* to provide calibration services ISO17025 in temperature (n ) IIIIIIIII Efficient, simple & easy to use thanks to the Labguard software compatibility IIIIIIIII Used by the majority of our clients that need to be compliant with the ISO standards * Member of ILAC Organization (International Laboratory Accreditation Cooperation). Calibration kit IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII l A complete solution to calibrate, check and adjust all Labguard range monitoring and transport sensors. l Labguard software automatically configures and manages the calibration bath. l Automate your calibrations via the bath control and automatic stage stability detection systems. l Manage calibration certificate validity periods. Calibration kit: composed by temperature reference sensor with high accuracy to calibrate and adjust temperature sensors within the range of -90 C to +200 C. Calibration bath: used to calibrate and adjust several temperature sensors at the same time, with several different temperature settings. Range: -30 C to +130 C (silicone oil included). Reference MD4001 Designation Calibration kit Calibration bath 12

15 Characterization (mapping) kit IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII l Manage all the thermostatic chambers and mapping traceability (from 9 to 15 sensors). l Centralize your mapping data in the Labguard software solution, for data sharing. l Comply with the FDX and IEC X standards. l Carry out mapping operations on a laptop disconnected from the main system, with data synchronization when the laptop is reconnected to the system. Temperature reference sensor is a high accuracy reference sensor to calibrate and adjust temperature sensors within the range of - 80 C to C. Metrology Reference Designation Mapping kit (PT100 only) PT100 sensor for Mapping kit (x1) Metrology Services IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII Metrology ISO C/ F Temperature calibration services available for Labguard 3D Reference Type of allocation All applications Deep freezer Freezer Refrigerator Ambiant Incubator Sterilization Calibration points -30 /+5 / +23 /+44 C -80 C -30 /-25 / -20 C +2 /+5 / +8 C +18 /+23 / +28 C +30 /+37 / +44 C +40º/+121ºC Sensor Temp -30 to +80 C l l l l l Sensor PT to +130 C l l l l l l l Adapter PT to +200 C l l l l l l l Mobiguard to +40 C l l l l l Mobiguard to +40 C l l l l l Mobiguard to +40 C l l l l l Reference Type of allocation Point on request Point on request Point on request Calibration points -40 C < 1Pt < +150 C -40 C < 1Pt > +150 C -40 C < 1Pt > +150 C Characterization kit (9 or 15 probes) 20 /+5 /+44 C Characterization kit (9 or 15 probes) -80 /-20 / +5 /+44 /+110 C Reference kit (Standard sensor) 5 points chosen within the range -30 C/+130 C (By default -30 /0 /+20 / +44 /+125C) Sensor Temp -30 to +80 C l Sensor PT to +130 C l l Adapter PT to +200 C l l Mobiguard to +40 C l Mobiguard to +40 C l Mobiguard to +40 C l Calibration Kit l l l Characterization Kit l l l 13

16 Humidity calibration services available for Labguard 3D Reference Type of allocation Ambiant 1 point on request Calibration points 55% / 23 C 5% < 1Pt HR < 95% Sensor Temp/Humidity 20 to 80% l l Sensor Temp/Humidity 0 to 100% l l Mobiguard 868 TEMP/HUM l l Mobiguard 915 TEMP/HUM l l Mobiguard 433 TEMP/HUM l l C0 2 C0 2 calibration services available for Labguard 3D Reference Type of allocation 1 point (at 37 C) Calibration points 0,5%, 5% or 10% Sensor CO 2 0 to 10% l Sensor CO 2 0 to 10% l TRACEABLE METROLOGY Reference Type of allocation Calibration points Global all applications -30º/+5º/ +23º/+44ºC Freezer Refrigerator Ambiant Incubator Sterilization -30º/-25º/ -20ºC +2º/+5º/ +8ºC +18º/+23º/ +28ºC +30º/+37º/ +44ºC +40º/+121ºC Point on request -40ºC < 1Pt < +150ºC Characterization Kit (9 or 15 probes) Sensor Temp -30 to +80 C l l l l l l Mobiguard to +40 C l l l l l l Mobiguard to +40 C l l l l l l Mobiguard to +40 C l l l l l l Sensor PT to +130 C l l l l l l l Adapter PT to +200 C l l l l l l l Characterization Kit l -20º/+5º/ +44ºC Important: references are presented as example. We can provide more calibrations for non-iso standards (named traceable). Please advise your biomérieux contact for the complete offer with more information. Qualification Guide IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII Reference Version DE SP IT PT FR EN 14

17 accessories accessories Reference Name Number of unity Power Supply UK Battery Li Transmitter Battery Li Mobiguard Adapter Relay for Receiver Cable µusb/usb Cable Ethernet Sensor Mounting Clamp Cap Protect Usb Connector Cap Protect Sensor Connector Probe Pt to +200 C Power Supply EU Power Supply US Power Supply UK Power Supply AU/CN Transmitter Radio Wall Mount Transmitter Ethernet Wall Mount Receiver Wall Mount Mobiguard Wall Mount Power Supply Au/Cn Cable Extension for Sensor 1M 1 MD12301 Probe Pt100 Nitro Tank 1 MD12313 Probe Tck +200 to C 1 MD13411 Probe Pt100 Calib Kit 1 MD4001 Calibration Bath Tpm 165S 1 MD4002 Silicone Oil 1 Liter (-30C to +130 C) 1 MD4003 Tripod For Bath Tpm 165S 1 MD4004 Perforated Cap For Bath Tpm 165S 1 MD4005 Calibration Bath Interface 1 MD5041 Gprs Modem (Sms + Voice) 1 15

18 04-14 / /011/GB/A / Document and/or pictures not legally binding. Modifications by biomérieux can be made without prior notice / biomérieux, the blue logo, Labguard and BIOMERIEUX PERFORMANCE SOLUTIONS are used, pending and/or registered trademarks belonging to biomérieux, or one of its subsidiaries, or one of its companies. Any other name or trademark belonging to the property of its respective owner / biomérieux S.A. RCS Lyon / Photos: GraphicObsession, Fotolia / Printed in France / THERA Conseil RCS Lyon B biomérieux S.A Marcy l Etoile France Tel. : 33 (0) Fax : 33 (0)