Labguard 3D Technical brochure

How will Labguard® watch over your quality?

bioM

erieu

x will a

ssist you as a partner using

the full range of dedicated services.

BIOMERIEUX PERFORMANCE SOLUTIONS™ • Quality & Compliance Services

How will Labguard® watch over your quality?

EVALUATIONl Pre-installation evaluation with our experts

to assess the installation constraints of your infrastructure

l Complete configuration of the network

SERVICE AGREEMENTl Specialists dedicated to Labguard® systemsl International hotline for assistancel Remote engineering, applications, software supportl Contract for adjustments and preventive maintenance

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 protocoll Test sheets (for each qualification phase)l Phase conclusion sheets

TRAININGl Complete training on the equipment for users and

administratorsl Dedicated training for metrology

METROLOGY SERVICESbioMérieux offers a full range of metrology services adapted to your needs and regulatory requirements:l Temperature reference sensorl Calibration/adjustment & characterization kitl Calibration/adjustment & characterization license l External or internal calibration & adjustments sensorsl ISO 17025 accredited or traceable metrology available

LABGUARD® 3D SERVICES

l Record all equipment needs in the Labguard® software l Configuration of monitoring (set points, alarm thresholds ...)

and metrological parameters

2

Please ask your bioMérieux contact for more information.

bioM

erieu

x will a

ssist you as a partner using

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 PERFORMANCE SOLUTIONS™ • Quality & Compliance Services

MOBILITY

HARDWARE

SOFTWARE

METROLOGY

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

• Complete range of tools

• bioMérieux quality services

• ISO or Traceable metrology

MOBILITY

HARDWARE

SOFTWARE

METROLOGY

• Unique innovative design

• High performance battery

• High-tech with visual alarms

• True web server

• Flexibility and scalability

• 24/7 real-time monitoring

HAR

DW

ARE

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 transmitter

IIIIIIIII Scalable - radio & Ethernet transmitter - battery, power supply & Power Over Ethernet connection

IIIIIIIII Metrology - certificate embedded in the sensor

• True web server

• Flexibility and scalability

• 24/7 real-time monitoring

4 parameters on the same transmitter

4 differents chambers monitered on the same transmitter

3

Reference 416010 416013 416017 416011 416014 416016 416012 416015 416018

Communication

Radio Band 868 Mhz 915 Mhz 433 Mhz 868 Mhz 915 Mhz 433 Mhz 868 Mhz 915 Mhz 433 MhzPower (up to) 25 mW 25 mW 10 mW 25 mW 25 mW 10 mW 25 mW 25 mW 10 mW Type Radio frequencyConnectivity USB / Radio frequencyTransmission Rate 9600 bps

Display No Yes Yes

ChannelNumber 1 2 4Connectivity M8 Male 4 Points

TransmitterDimension (HxWxD) 123 X 107 X 31 mmWeight 190 g

Comsumption

Connectivity Lithium Battery / USB / SectorBattery 2 Lithium Battery Li AA 3,6 V, 2600 mAh Sector 5VDC, 1A with power supplyStandby 5 µATransmission 50 mABattery Lifetime Until 2 years

Internal Memory Data stored in the sensorsProtection Index IP55Software Compatibility All Labguard® Software Pack From Fuchsia VersionIncluded Lithium Battery, Wall Mount

l No display & one input availablel 360° - projected visual alarmsl 3 radio frequencies availablel Automatic detection of new sensorsl Real time or data logging

communication

l Alert for battery & lost communication l Simple action buttonsl Lithium battery, USB or power supplyl Wall mounted kit

l Display with 2 universal inputs

l All type of sensors in the same transmitter

l Plug & play sensors

l Display with 4 universal inputs

l Worldwide innovation

Conformities

CE 868 Mhz FCC 915 Mhz IC 915 Mhz

DIRECTIVESR&TTE 1999/5/CE

STANDARDS RADIO & EMCCFR 47 FCC

Part 15STANDARDS RADIO & EMC

RSS-Gen / RSS-210

Issue 8 : DEC10

Low Voltage 2006/95/CEEMC 2004/108/CE

STANDARDS

EN 301 489-3 V 1.4.1 : 2002EN 300 220-1 V2.4.1 : 2012EN 300 220-2 V2.4.1 : 2012

EN 61010-1 : 2010EN 61326-1 : 2006EN 62479 : 2010

Radio Transmitter IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII

4

l Display with 4 universal inputsl Power Over Ethernet / USB or Power supply l 360° - projected visual alarmsl Automatic detection of sensorsl Real time or data logging communicationl Simple action buttonsl Wall mounted kit

Ethernet Transmitter IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII

Reference 416019

Communication

Type Ethernet

Connectivity Ethernet/USB

Transmission rate 10/100Mbps

Interface Ethernet Connecteur RJ45

Network protocol TCP/IP

Port used 5807

Display Yes

ChannelNumber 4

Connectivity M8 Male 4 Points

TransmitterDimension (HxWxD) 135 x 93 x 33mm

Weight 195g

ConsumptionConnectivity Ethernet/USB/sector

Power Over Ethernet Power Classe 1 (3,84W max)

Internal memory Data stored in the sensors

Software compatibility All Labguard® Software Pack From Fuchsia Version

Included Lithium battery, Wall mount, RJ45 3m cable

Conformities

CE FCC IC

DIRECTIVES Low Voltage 2006/95/CE

STANDARDS EMCCFR 47 FCC

Part 15STANDARDS EMC

ICES 003 : 2012

EMC 2004/108/CE

STANDARDSEN 61010-1 : 2010EN 61326-1 : 2006EN 62311 : 2008

HAR

DW

ARE

Name of channel

Level of radiocommunication

Number of channel

Alarm & status Data measurement & unit

Level of battery

5

l Coloured visual alarms

l USB or Ethernet available connection

l USB - Ethernet adapters included - Power-over Ethernet

l Wall mounted kit

Radio Receiver IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII

Reference 416035 416036 416037

Communication

Radio Band 868 Mhz 915 Mhz 433 Mhz

Power (up to) 25 mW 25 mW 10 mW

Connectivity Ethernet/USB/Radio frequence

Port used 5807

Network protocol TCP/IP

IP address allocation DHCP or fixed

ReceiverDimension (HxWxD) 55 x 103 x 31 mm

Weight 90 g

Consumption

Sector 5VDC, 1A with power supply & POE

Power Over Ethernet Power Classe 1 (3,84W max)

Connectivity Ethernet/USB

Consumption 300 mA


Included Wall mount, RJ45 & USB 2m cable

6

Conformities

CE FCC IC




RSS-Gen / RSS-210


STANDARDS

EN 301 489-3 : 2002 V 1.4.1EN 300 220-2 V2.4.1

EN 61010-1 : 2010EN 61326-1 : 2006

l Numeric sensor with unique IDl Internal memory (3800 data)l Metrology certificate inside

l Calibration ISO 17025 availablel Fully plug & play sensorl Large range of sensors

Sensors IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII

HAR

DW

ARE

Sensor Temp Sensor PT100 Sensor Humidity Sensor Humidity Sensor Co2 Sensor Co2

Reference 416038 416042 416039 416045 416043 416044Application Temperature High Temperature Humidity & Temperature Humidity & Temperature CO2 CO2

Operating range -30° to +80°C -90° to +130°C20 to 80 % HR &

0° to 60°C0 to 100 % HR &-40° to +80°C

0 to 10% CO2

-20° to +60°C0 to 20% CO2

-20° to +60°CDimensions of sensor L = 45 mm L = 30 mm L = 55 mm L = 80 mm L = 100 mm L = 100 mmDiameter of sensor 10 mm 3 mm 12 mm 12 mm 18 mm 18 mmFilter N/A N/A PTFE 1µm PTFE 0,2 µm PTFE 0,2 µm PTFE 0,2 µmLength of cable 2 m 2,5 m 2 m 2 m 2 m 2 mFlat cable YES NO YES YES NO NOSize 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

Best accuracy ±0,20°C* ±0,15°C*±0,30°C* ±5% RH

±0,20°C* < ±2.5% RH

1,5% of range +2% of reading

1,5% of range +2% of reading

Resolution 0,06°C 0,01°C 0,1% RH 0,1% RH 0,1% CO2 0,1% CO2

Power supply N/A N/A N/A N/A** Included IncludedProtection index IP68 IP68 N/A IP65 IP65 IP65

Sensor differentialpressure

Adapter Thermocouple K

Adapter input for dry contact

Adapter relay for dry contact

Adapter PT100

Adapter 0-10 V

Adapter 0-20 mA

Reference 416046 416052 416047 416050 416051 416041 416040

ApplicationDifferentialpressure

Very High Temperature

IN IN/OUTHigh

TemperatureSignal Signal

Operating range Adjustable -200° to +1 200°C N/A2 A to 30 V DC/AC

0,3 A to 230 V DC/AC-200° to +300°C

0 - 10 V 0-20 mA

Dimensions of sensorL x W x H =

90 x 71,5 x 36 mmN/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 mFlat cable NO YES NO NO NO NO NOSize 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

Best accuracy±0,5% Pa

+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 0,001Power supply Included N/A N/A N/A N/A N/A N/AProtection index IP54 N/A N/A N/A N/A N/A N/A

* bioMérieux calibration. ** Power supply transmitter recommended. 7

Temperature sensor

PT 100 Humidity sensor

MOBILITY

l Radio communicationl 360° - projected visual alarms &

acquisition buttonl Alarms provided in real time to the userl Replaceable batteryl Temperature or/& humidity monitoringl Waterproof

Mobiguard for temperature & humidityMobiguard for temperature

Mobiguard IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII

Reference 416026 416027 416028 416029 416030 416031

Communication

Type Radio frequencyRadio Band 868 Mhz 915 Mhz 433 Mhz 868 Mhz 915 Mhz 433 MhzTransmission rate 9600 bpsPower (up to) 25mW 25mW 10mW 25mW 25mW 10mW

Sensors range

Application Temperature Temperature / Humidity

Temperature -30° +60°C -30° +60°C

Humidity N/A 20 ~ 80 % RH

Best accuracy* ±0.20°C ≤ 0.5°C* ±5 % RH

Protection index IP67 IP44

MaterialDimension (HxWxD) 61 x 94 x 23 mmWeight 110 g

Consumption

Type 2 Battery Li AAA 1,5 V, 1200 mA Standby 5 µATransmission 50 mABattery lifetime 1 year

Internal memory Around 3800 measurements


Included Lithium battery, Wall mount

8

Conformities

CE FCC IC




RSS-Gen / RSS-210


STANDARDS

EN 301 489-3 : 2002 V 1.4.1EN 300 220-2 V2.4.1

EN 61010-1 : 2010EN 61326-1 : 2006

* bioMérieux calibration.

MO

BIL

ITY

Tomkey data loggerl 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 loggerl Comes in a button cell formatl Can be connected to a PC via a USB adapter

Others solutions IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII

Reference 416049 MD30101 MD31011 MD31121 MD31020Name Tomkey Tomprobe Tomprobe Tomclave Interface USB

Application Temperature Temperature High Temperature Capsule Interface

Memory (values) 8000 2048 2048 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 MD6188Name Mobility Manager license

ApplicationStandalone availability for Labguard Mobiguard,

Tomkey & Tomprobe

9

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

IIIIIIIII Traceability - fully compatible with Labguard® Software and Mobility Manager

IIIIIIIII Compliance - calibration ISO17025 available

IIIIIIIII Flexibility - no installation needed

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)

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Alarm notification by widget

Full web - based installation

Notification via email

SOFT

WAR

E

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: allows 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 automa-tically updated from your company/database.

Modbus license: communication protocol used for Building Management System (BMS) including HVAC (Heating, Ventilation, Air Conditioning). Allows Labguard software to communicate data to the customer’s BMS infrastructure.

Calibration license: allows to carry out Labguard sensors calibration and adjustment.

Characterization license: allows to carry out temperature characterization (mapping) of thermostatic chambers using FDX 15140 or IEC 60068-3-X standards, with up to 15 temperature points.

License WELCOME

License EXECUTIVE

License INTEGRAL

Reference MD6111 MD6171 MD6179

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

MD6180 21 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

MD6105 MASTER LABGUARD SOFTWARE CD + book jacket + mouse pad

l Included l Optional l Non applicable

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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°2-5717) Jan. 2014

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).

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).

Calibration kit IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII

Reference 415431 MD4001Designation Calibration kit Calibration bath

12

★★★★

★★★★

MET

ROLO

GY

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 15-140 and IEC 60068-3-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 calibration services available for Labguard 3D®

Characterization (mapping) kit IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII

Metrology Services IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII

Reference 415432 415002Designation Mapping kit (PT100 only) PT100 sensor for Mapping kit (x1)

Reference 415431 MD4001Designation Calibration kit Calibration bath

Reference 2300847 2300848 417493 2300843 2300844 2300849

Type of allocation Point on request Point on request Point on requestCharacterization kit(9 or 15 probes)

Characterization kit(9 or 15 probes)

Reference kit(Standard sensor)

Calibration points -40°C < 1Pt <

+150°C -40°C < 1Pt >

+150°C -40°C < 1Pt >

+150°C20°/+5°/+44°C

-80°/-20°/ +5°/+44°/+110°C

5 points chosen within the range-40°C/+150°C

(By default -30°/0°/+20°/ +44°/+125C)

416038 Sensor Temp -30° to +80°C l

416042 Sensor PT100 -90° to +130°C l l

416051 Adapter PT100 -200° to +200°C l l

416026 Mobiguard 868 -30° to +40°C l

416027 Mobiguard 915 -30° to +40°C l

416028 Mobiguard 433 -30° to +40°C l

415431 Calibration Kit l l l

415432 Characterization Kit l l l

Reference 2300845 2300846 2300834 2300814 2300835 2300841 2300842Type 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

416038 Sensor Temp -30° to +80°C l l l l l

416042 Sensor PT100 -90° to +130°C l l l l l l l

416051 Adapter PT100 -200° to +200°C l l l l l l l

416026 Mobiguard 868 -30° to +40°C l l l l l



Temperature reference sensor is a high accuracy reference sensor to calibrate and adjust temperature sensors within the range of - 80°C to + 200°C.

°C/°F

13

METROLOGY ISO 17025

Humidity calibration services available for Labguard 3D®

C02 calibration services available for Labguard 3D

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.

Reference 417496 417495Type of allocation Ambiant 1 point on request

Calibration points 55% at 23°C 5% < 1Pt HR < 95%

416039 Sensor Temp/Humidity 20 to 80% l l

416045 Sensor Temp/Humidity 0 to 100% l l

416029 Mobiguard 868 TEMP/HUM l l



Reference 417494Type of allocation 1 point (at 37°C)

Calibration points 0,5%, 5% or 10%

416043 Sensor CO2 0 to 10% l

416044 Sensor CO2 0 to 20% l

Reference 416058 416059 416060 416061 416065 416066

Version DE SP IT PT FR EN

14

TRACEABLE METROLOGY

Qualification Guide IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII

Reference 2300856 2300850 2300851 2300852 2300853 2300854 2300857 2300855

Type of allocationGlobal all

applicationsFreezer Refrigerator Ambiant Incubator Sterilization

Point on request

Characterization Kit (9 or

15 probes)

Calibration points-30º/+5º/

+23º/+44ºC-30º/-25º/

-20ºC+2º/+5º/

+8ºC+18º/+23º/

+28ºC+30º/+37º/

+44ºC +40º/+121ºC

-40ºC < 1Pt < +150ºC

-20º/+5º/ +44ºC

416038 Sensor Temp -30° to +80°C l l l l l l

416026 Mobiguard 868 -30° to +40°C l l l l l l



416042 Sensor PT100 -90° to +130°C l l l l l l l

416051 Adapter PT100 -200° to +200°C l l l l l l l

415432 Characterization Kit l

C02

ACC

ESSO

RIES

ACCESSORIES

Reference Name Number of unity

416067 Battery LI Transmitter 2

416068 Battery LI Mobiguard 2

416069 Adapter Relay for Receiver 1

416070 Cable µUSB/USB 1

416072 Cable Ethernet 1

416073 Sensor Mounting Clamp 20

416074 Cap Protect USB Connector 3

416075 Cap Protect Sensor Connector 10

415002 Probe PT100 -200° to +200°C 1

416053 Power Supply EU 1

416054 Power Supply US 1

416055 Power Supply UK 1

416056 Power Supply AU/CN 1

416020 Transmitter Radio Wall Mount 1

416021 Transmitter Ethernet Wall Mount 1

416022 Receiver Wall Mount 1

416023 Mobiguard Wall Mount 1

416057 Cable Extension for Sensor 1M 1

MD12301 Probe PT100 Nitro Tank 1

MD12313 Probe TCK 0 to +1100°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

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Qualification Guide IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII

bioMérieux S.A.69280 Marcy l’EtoileFranceTel. : 33 (0)4 78 87 20 00Fax : 33 (0)4 78 87 20 90www.biomerieux.com www.labguard.com01

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Labguard 3D Technical brochure

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Transcript of Labguard 3D Technical brochure