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bioMerieux Air IDEAL 3P Traceability Solution User Manual

bioMerieux Air IDEAL 3P Traceability Solution
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Air IDEAL
®
3P
TM
Traceability
Solution
AeroBioCollector
User's Manual
96307 - I en - 2013/09 P/N 161150 - 190
LCB 71260 La Salle France
Distributed by :
bioMérieux SA Chemin de l'Orme
69280 Marcy-l'Étoile - France
RCS Lyon 673 620 399
Tel. 33 (0)4 78 87 20 00
Fax 33 (0)4 78 87 20 90
www.biomerieux.com

Table of Contents

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bioMerieux Air IDEAL 3P Traceability Solution Specifications

General IconGeneral
BrandbioMerieux
ModelAir IDEAL 3P Traceability Solution
CategoryAccessories
LanguageEnglish

Summary

Revisions

Warning

Trademarks

1 How to Use This Manual

Finding Topics and Procedures

Explains how to navigate the manual using the table of contents, list of figures, and warnings.

Glossary

Defines key terms and abbreviations used throughout the manual.

Typographic Conventions

Explains formatting conventions for text, actions, and display messages.

Keypad Overview

Describes the instrument's keypad layout and button functions.

2 Functional Description

Product Presentation and Principle of Use

Introduces the AeroBioCollector, its purpose, and operational modes (slave/manual).

Operating Principle

Details the impaction mechanism and airflow process for sampling airborne microorganisms.

Performance Characteristics

Discusses the instrument's efficiency in collecting viable microorganisms with optimal impaction velocity.

Validation and Testing Approaches

Covers ISO 14698 validation, physical, and biological efficiency testing methods.

Glove Box Compatibility

Highlights design modifications and validation for use in glove box environments.

Instrument Applications

Outlines the broad range of environments and applications suitable for the air sampling instrument.

3 Using Air IDEAL®3P ™ Traceability

Instrument Description and Accessories

Describes the instrument's packaging, versions, and available accessories.

Consumables and Identification

Lists compatible consumables and how to identify the instrument.

Instrument Views and Controls

Illustrates front/rear views, keypad, sampling grid, and Petri dish configurations.

Sampling Head and Tripod Assembly

Details the sampling head and the optional tripod assembly for instrument positioning.

General Specifications

Provides technical, environmental, and physical characteristics, dimensions, mass, and materials.

Technical and Ergonomic Features

Details keypad, display, user interface, and ergonomic handle of the instrument.

Electrical Characteristics

Covers voltage, power supply, and adapter specifications for the instrument.

Functional Specifications

Details flow-rate, autonomy, charge time, sound level, and security features.

Unpacking and Initial Setup

Instructions for unpacking, initial setup, and important first-time usage recommendations.

Sampling Positions

Illustrates various ways to position the instrument for sampling, including in glove boxes.

Sampling Grid Attachment

Provides instructions and cautions for securely attaching the sampling grid to the instrument.

Power Supply and Battery Operation

Explains how the instrument operates using its internal battery or external mains power.

Low Battery Indicators

Describes the visual and audible signals indicating low battery status and remaining life.

Battery Charging Procedures

Outlines the steps and precautions for charging the instrument's battery.

Mains Power Operation and Standby

Details operating the instrument from mains power and its automatic standby mode.

Automatic Switch Off

Explains the instrument's automatic shutdown feature after a period of inactivity.

Slave Mode Operation

Instructions for using the instrument when controlled by a RUID.

Manual Mode Operation

Explains how to operate the instrument autonomously using its keypad.

Programming Instrument Functions

Covers programming options, characteristics, and control features for sampling operations.

Air IDEAL®3P™ Traceability Menus

Presents a diagram illustrating the instrument's menu structure and navigation flow.

Turning On the Instrument

Step-by-step guide on powering on the instrument and interpreting the initial display.

Instrument Standby and Reactivation

Explains how to put the instrument into standby mode and how to reactivate it.

Turning Off the Instrument

Instructions on how to properly power down the instrument.

Selecting Pre-programmed Sample Volumes (Menu 1)

Guides the user on selecting one of the four factory-set sample volumes via Menu 1.

Programming Sample Volumes (Menu 2)

Instructions for programming a custom sample volume not stored in memory using Menu 2.

Modifying Pre-programmed Sample Volumes (Menu 3)

Details how to change the four pre-programmed sample volume settings using Menu 3.

Programming Delayed Start-up (Menu 4)

Explains how to set a delayed start time for sampling operations using Menu 4.

Programming Sequenced Sampling (Menu 5)

Guides the user on setting up multiple sampling sequences with specific intervals using Menu 5.

Battery Autonomy Test (Menu 6)

Describes how to perform a battery life test and check its compliance with specifications.

Starting Sampling Operation

Step-by-step instructions on how to initiate a sampling cycle on the instrument.

Stopping the Sampling Motor

Explains how to safely stop an ongoing sampling operation.

Parameter Setting Summary Diagram

Provides a visual overview of how to navigate and set various instrument parameters.

Maintenance Menu Navigation

Illustrates how to access and navigate the instrument's maintenance menu using the keypad.

4 Procedure

Procedure Principle and Requirements

Outlines the principles of aerobiocontamination measurement and requirements for quality sampling.

Detailed Sampling Procedure

Covers precautions, manual sampling steps, and instrument handling during the process.

Incubation and Reading of Samples

Instructions on proper incubation of Petri dishes and how to read and interpret results.

Sampling Plan Development

Guidance on creating a sampling plan, including critical points, frequency, and volume.

Recording and Evaluating Results

Details the documentation required for recording and evaluating air sampling results.

5 Maintenance

Preventive and Routine Servicing

Information on user-performed maintenance tasks like battery charging and cleaning.

Cleaning and Decontamination

Procedures for cleaning external parts, air circuits, and use in glove boxes.

Sterilization of Grids

Guidelines on sterilizing the sampling grids via autoclaving.

Airflow Control Procedure

Specifies when and how airflow control should be performed by authorized personnel.

6 Troubleshooting

Troubleshooting Indicator Lights and Error Messages

Lists error messages and indicator light statuses with possible causes and actions.

Motor Jamming and Calibration Issues

Addresses issues related to motor jams and expired calibration dates.

Battery Status and Serial Number Errors

Covers troubleshooting for low battery, unknown serial numbers, and missing calibration data.

7 Appendix

Using the Reading Table

Explains how to use the provided tables to interpret CFU counts.

Information on Feller's Law

Provides the formula and context for Feller's law used in MPN calculations.

Reading Tables Data

Presents the actual data tables used for converting CFU counts to MPN values.