Air IDEAL®3P
TM
www.biomerieux.com
Traceability
Solution
AeroBioCollector
User's Manual
96307 - I – en - 2013/09 — P/N 161150 - 190
Distributed by :
LCB 71260 La Salle France
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
7BRevisions
The list of revisions below summarizes replacements or additional pages in your User’s
Manual
Version
Date of
printing
Modifications Pages modified
A 2001/01 Bilingual
(FR / EN)
B 2001/04 Multilingual
(FR / EN / ES / IT / DE / PT)
C 2005/11 Update of the manual
(FR / EN / ES)
D 2006/03 Update of the manual
(FR / EN / ES / IT / DE / PT)
E 2008/03 Environmental conditions
(FR / EN / ES / IT / DE / PT)
F 2010/10 Addition of a remote user interface device (RUID)
to ensure sampling traceability.
G 2011/04 Regulatory modifications:
FCC (USA) and IC (Canada).
All
All
All
All
2-12
All
Pages 2-7, 2-8, 2-11, 2-13
Pages 3-2 and 5-1
H 2011/11 Airflow control 5-1
I 2013/09 Modification of spelling:
- airIDEAL
®
3PTM Traceability
becomes
- Air IDEAL®3PTM Traceability.
Software version change from V9 to V10.
Modification of agar plate references: 96302
becomes 410175 and 96303 becomes
410174.
Deletion of ref 43018
Modification of serial number label
Addition of figure "Diameter of Petri dishes".
Modification of section:
- "Characteristics of materials".
Modification of sections:
- "Cleaning and decontamination procedure"
- "Decontamination of the external part".
All
Warning
3-1
3-2
3-2
3-4
3-6
5-1
5-2
Air IDEAL
®
3P™ Traceability Solution AeroBioCollector User's Manual Revisions-1
Warning
IMPORTANT! Use of the instrument and manual implies acceptance of the clauses below and the
The content of this manual is based on the Software release 10.
This manual is periodically updated. The updates shall be included in the new releases of
the Software.
Information supplied in this manual may be subject to modifications before the products
described become available.
This manual may contain information or references relating to certain bioMérieux SA
products, software or services which are not available in the country of release; this shall not
mean that bioMérieux SA intends to market such products, software or services in such
country
To request copies of publications or for any technical request, contact bioMérieux SA or your
local distributor.
clauses set out in the regulatory booklet. Users are invited to refer to these clauses.
DANGER! To ensure user safety, the instrument must be used in accordance with this manual.
Trademarks
BIOMERIEUX, the blue logo, 3P, Air IDEAL and Count-Tact are used, pending and/or
registered trademarks belonging to bioMérieux, or one of its subsidiaries, or one of
its companies.
ClearKlens IPA is a trademark belonging to Johnson Diversey.
Any other name or trademark is the property of its respective owner.
© 2010 - 2013 bioMérieux SA
Photos: bioMérieux / Printed in France / bioMérieux SA RCS Lyon 673 620 399
Table of contents
1 How to use this manual ........................................................................................................................ 1-1
Finding topics and procedures ......................................................................................................................................1-1
Glossary .......................................................................................................................................................................1-2
Typographic conventions ..............................................................................................................................................1-3
Air IDEAL®3P™ Traceability keypad ............................................................................................................................1-3
2 Functional description .......................................................................................................................... 2-1
Presentation .................................................................................................................................................................2-1
Principle of use .........................................................................................................................................................2-1
Operating principle ...................................................................................................................................................2-2
Performance .............................................................................................................................................................2-2
Collection efficiency validated according to the ISO 14698 standard ...................................................................2-3
Physical efficiency testing approach .....................................................................................................................2-3
Biological efficiency testing approach ...................................................................................................................2-3
Use in glove boxes ...............................................................................................................................................2-3
Applications ..............................................................................................................................................................2-3
3 Using Air IDEAL®3P™ Traceability ...................................................................................................... 3-1
Description ....................................................................................................................................................................3-1
Consumables ............................................................................................................................................................3-2
Culture media for general use ..............................................................................................................................3-2
Irradiated media ....................................................................................................................................................3-2
Identification of the instrument ..................................................................................................................................3-2
Front face of the Air IDEAL®3P™ Traceability ..........................................................................................................3-3
Rear face of the Air IDEAL®3P™ Traceability ..........................................................................................................3-3
Keypad .....................................................................................................................................................................3-4
Sampling grid ................................................................................................................................................................3-4
Configuration for 65, 70 or 90 mm Petri dishes ........................................................................................................3-4
Tripod assembly .......................................................................................................................................................3-5
General specifications ..................................................................................................................................................3-6
Environmental conditions..........................................................................................................................................3-6
Physical features ......................................................................................................................................................3-6
Dimensions ...........................................................................................................................................................3-6
Mass .....................................................................................................................................................................3-6
Materials ...............................................................................................................................................................3-6
Characteristics of materials ..................................................................................................................................3-6
Technical characteristics ..........................................................................................................................................3-7
Electrical characteristics ...........................................................................................................................................3-8
Functional specifications...........................................................................................................................................3-8
Unpacking Air IDEAL®3P™ Traceability .......................................................................................................................3-9
Recommendations for installation and use ...................................................................................................................3-9
Sampling positions .....................................................................................................................................................3-11
Screwing on the sampling grid ....................................................................................................................................3-12
Electrical power supply ...............................................................................................................................................3-12
Operation on the battery .........................................................................................................................................3-12
Low battery signals .............................................................................................................................................3-13
Charging .............................................................................................................................................................3-13
Operation using mains power .................................................................................................................................3-14
Automatic standby ..................................................................................................................................................3-14
Automatic switch off ................................................................................................................................................3-14
Operation in slave mode .............................................................................................................................................3-15
Operation in manual mode .........................................................................................................................................3-15
Programming ..........................................................................................................................................................3-15
Programming characteristics ..............................................................................................................................3-15
Sampling controls ...............................................................................................................................................3-15
Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual I-1
Table of contents
Air IDEAL®3P™ Traceability menus ...................................................................................................................... 3-16
Turning on Air IDEAL®3P™ Traceability ................................................................................................................ 3-17
Standby .................................................................................................................................................................. 3-18
Turning off Air IDEAL®3P™ Traceability ................................................................................................................ 3-18
Selection of one of the 4 pre-programmed sample volumes (Menu 1) .................................................................. 3-18
Programming a sample volume not in memory (Menu 2) ...................................................................................... 3-19
Modification of the 4 pre-programmed sample volumes (Menu 3) ......................................................................... 3-20
Programming delayed start-up (Menu 4) ............................................................................................................... 3-22
Programming sequenced sampling (Menu 5) ........................................................................................................ 3-23
Battery autonomy test (Menu 6) ............................................................................................................................. 3-25
Starting sampling ....................................................................................................................................................... 3-26
Stopping the motor ................................................................................................................................................ 3-28
Setting Air IDEAL®3P™ Traceability parameters (summary diagram) ....................................................................... 3-29
Maintenance Menu .................................................................................................................................................... 3-31
Navigation using < + > and< - > keys .................................................................................................................... 3-31
4 Procedure ............................................................................................................................................... 4-1
Principle ....................................................................................................................................................................... 4-1
Procedure .................................................................................................................................................................... 4-1
How to obtain a good quality sample ........................................................................................................................... 4-2
Precautions of use ................................................................................................................................................... 4-2
Sampling in manual mode ....................................................................................................................................... 4-2
Incubation and reading ............................................................................................................................................ 4-2
Sampling plan .............................................................................................................................................................. 4-3
Recording and evaluating results ................................................................................................................................. 4-3
5 Maintenance ........................................................................................................................................... 5-1
Preventive maintenance .............................................................................................................................................. 5-1
Routine servicing ......................................................................................................................................................... 5-1
Cleaning and decontamination procedure ............................................................................................................... 5-1
Sterilization of grids ................................................................................................................................................. 5-1
Decontamination of external parts ........................................................................................................................... 5-2
Decontamination of the air circuit ............................................................................................................................. 5-2
Decontamination in a glove box ............................................................................................................................... 5-2
Airflow control .......................................................................................................................................................... 5-2
6 Troubleshooting .................................................................................................................................... 6-1
7 Appendix ................................................................................................................................................ 7-1
Using the reading table ................................................................................................................................................ 7-1
Information on FELLER’s law ...................................................................................................................................... 7-1
Reading tables ............................................................................................................................................................. 7-2
I-2 Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual
List of figures
Note: Screenshots and figures are given as examples only.
2. Functional description
Figure 2-1: Principle of the impaction biocollector ............................................................................................................2-2
3. Using Air IDEAL®3P™ Traceability
Figure 3-1: Air IDEAL®3P™ Traceability in its carrying case ............................................................................................3-1
Figure 3-2: Identification of the instrument .......................................................................................................................3-2
Figure 3-3: Front face .......................................................................................................................................................3-3
Figure 3-4: Rear face ........................................................................................................................................................3-3
Figure 3-5: Keypad ...........................................................................................................................................................3-4
Figure 3-6: Diameter of Petri dishes .................................................................................................................................3-4
Figure 3-7: Sampling head and grid – 65, 70 or 90 mm Petri dishes ................................................................................3-5
Figure 3-8: Tripod assembly .............................................................................................................................................3-5
Figure 3-9: Sampling positions .......................................................................................................................................3-11
Figure 3-10: Screwing on the sampling grid ...................................................................................................................3-12
Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual II-1
Apart from the first page of every chapter, each page of the manual includes a page header
Each page header includes the chapter title and the title of a procedure or its corresponding
1 How to use this manual
IMPORTANT! Please read the "General safety and regulatory information" booklet provided with the
instrument.
Finding topics and procedures
This manual is divided into 7 chapters.
Table of contents
The table of contents of the manual is located on pages I-1 to I-2.
It lists each chapter and the procedures within each chapter.
List of figures
Warnings
Page headers and
page footers
The list of figures for the manual is located on page II-1.
Different types of warnings are used throughout the manual:
- for safety reasons (DANGER!),
- to ensure that the instruments are maintained in good working condition (CAUTION!),
- for regulatory reasons (WARNING!) or,
- for optimum performance of operations, procedures, etc. (IMPORTANT!).
and a footer.
description.
The footers contain the title of the manual, the name of the product and the page number.
Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual 1-1
How to use this manual
instrument used to collect and count viable bacterial and
organisms collected. Statistical correction of the CFU
arithmetic mean of all profile deviations, positive or
their diameter and
arrangement, guarantee a CFU count (positive clusters) and a flow of air corresponding to
(AeroBioCollector) + RUID (remote control) +
Glossary
Glossary
ABS
AeroBioCollector or
Air sampler
CFU
Acrylonitrile butadiene styrene.
Air IDEAL®3P™ Traceability,
fungal particles in a known and precise volume of air.
Number of Colony Forming Units read on the agar plate.
The number of CFU corresponds to the number of clusters that have grown on the agar.
Delayed start-up
Li-ion
MPN
PVDF
Ra coefficient
Time between pressing the START button and the motor starting up.
Lithium ion
Most Probable Number of microvalue (FELLER’s law).
Polyvinylidene fluoride.
Roughness factor of a surface. It is the
negative, compared to the mean line.
RUID "Remote User Interface Device"
Remote control containing the user interface.
Sampling grid
Solution Air IDEAL®3P™
Traceability
Time-delay
Perforated and calibrated plastic device. The number of orifices,
the motor setting.
Air IDEAL®3P™ Traceability
Air IDEAL®3P™ Traceability software.
Two seconds required by the software to record a parameter.
1-2 Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual
•
Typographic conventions
These conventions are used in the different chapters of the manual.
How to use this manual
Typographic conventions
Press
PROGRAM 1
A bullet point is used to denote an action to be performed.
This typography is used to represent messages which appear on the display.
Air IDEAL®3P™ Traceability keypad
There are 5 keys on the instrument keypad. (See page 3-4 of the manual).
In this manual, the keys are referred to by their individual names, enclosed in angle brackets
"< >".
Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual 1-3
2 Functional description
Presentation
"Pharmaceutical manufacturing evolves from an art to a science".
This sentence alone from the FDA Guideline “Pharmaceutical cGMPs for the 21
A Risk-Based Approach” summarizes the current revolution in the Pharmaceutical industry.
Conscious of these changes and remaining attentive to its customers, bioMérieux decided to
improve its Air IDEAL
new needs.
The instrument was thus developed and validated in order to provide a tool to the
pharmaceutical industry that would guarantee a scientifically proven method of air sampling.
This instrument evidently remains perfectly suited to the enumeration of airborne microorganisms in less demanding work environments such as agribusiness.
In addition and in order to continue its universal application,
Air IDEAL®3P™ Traceability is still available in two versions:
− one for the use of culture media in 90 mm diameter Petri dishes,
− the other designed for use with 65 or 70 mm plates.
The aspiration flow-rate of Air IDEAL
impact velocity of less than 20 m/s.
According to good sterilization practices, sampling grids can be sterilized in an autoclave,
see "Sterilization of grids" on page 5-1.
®
3P™ Traceability AeroBioCollector in order to best respond to these
st
century –
®
3P™ Traceability is calibrated at 100 l/min with an
Principle of use
Air IDEAL®3P™ Traceability can operate in 2 modes:
• Slave mode: using Air IDEAL
• Manual mode: autonomous operation using the keypad.
®
3P™ Traceability with the RUID.
The present manual describes how to use the instrument in manual mode;
for use of the instrument in slave mode, please refer to the RUID User
Manual.
Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual 2-1
Functional description
Calibrated orifice
Air inlet
Nutrient medium
Air jets
Micro-organisms
Air outlet
90 or 65/70 mm diameter
Presentation
Operating principle
Air IDEAL®3P™ Traceability is an impaction AeroBioCollector used to detect the presence
of viable micro-organisms in the environment to be tested, by precise sampling of a given
volume of air.
Air is taken up with a turbine through a grid surface. The acceleration of airflow results in the
impaction of airborne micro-organisms on the agar. Passage of the air through the grid filters
out particles, thereby facilitating the enumeration of CFU (colony forming units) after
incubation of the medium.
A reading and statistical correction table is used to convert the number of CFU to the most
probable number of micro-organisms collected per m
Impaction
3
of air.
Petri dishes
Figure 2-1: Principle of the impaction biocollector
Performance
The performance characteristics of an AeroBioCollector depend on its capacity to collect
micro-organisms in the air without compromising their viability during impaction on the agar.
This property can be obtained only with a perfect compromise between the high aspiration
velocity leading to effective collection, and a sufficiently low impaction velocity to guarantee
the revivification of collected micro-organisms.
Air IDEAL
®
3P™ Traceability was developed in close cooperation with aeraulics experts in
order to optimize this ratio.
Since the industry has increasing needs for scientifically proven methods, bioMérieux
commissioned two recognized independent organizations
∗
to validate the physical and
biological efficiency of the instrument.
∗
CETIAT: Centre Technique des Industries Aérauliques et Thermiques/Technical Center of Aeraulic and Thermal Industries
HPA : Health Protection Agency - Porton Down - Wiltshire SP4 0JG Salisbury - UK
2-2 Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual
Domaine Scientifique de la Doua, 69603 Villeurbanne, France
Collection efficiency validated according to the ISO 14698 standard
Functional description
Presentation
Air IDEAL
®
3P™ Traceability was third party validated by the Health Protection Agency
(UK) to meet the requirements of ISO 14698-1 for the control of clean rooms. Both the
physical and biological efficiencies of the equipment have been validated according to this
standard.
Physical efficiency testing approach
The physical efficiency of an air sampler for collecting airborne bacteria is evaluated by
comparison with a membrane filter sampler. Uniform particles of different diameters
containing bacterial spores of Bacillus subtilis var niger were generated in a controlled room.
The physical efficiency of the instrument was determined by comparison with the membrane
filtration standard operating side-by-side.
Biological efficiency testing approach
Air sampler inefficiency can either be due to a failure of the sampler to capture particles
containing micro-organisms (physical loss), or to inactivation of viable micro-organisms
during collection, so that formation of visible colonies on agar will not occur (biological loss).
To address this point, Air IDEAL
of Bacillus subtilis (standard indicator for physical loss) and Staphylococcus epidermidis
(standard indicator for biological loss).
The ratio of S. epidermidis / B. subtilis for the test samplers was divided by the ratio
obtained with the reference standard membrane filter sampler to give a comparative
biological efficiency.
®
3P™ Traceability was evaluated for recovery of a mixture
Use in glove boxes
Applications
In order to be used to test glove boxes, the design and materials of
Air IDEAL
®
3P™ Traceability had to be entirely reviewed in order to optimize system air
tightness.
In addition and in order to guarantee the optimal operation of the instrument in this
application, the system underwent a complete validation in a glove box (SKAN AG, model
ARIS glove box).
Air IDEAL
®
3P™ Traceability enables precise and reproducible air sampling.
The volumes taken can be set in 10 l steps up to a maximum volume of 2000 l.
This sampling range enables the instrument to be used in all types of environments, from
sterile zones to more contaminated surroundings and in all applications, e.g. qualification of
sterile rooms or daily monitoring.
Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual 2-3
3 Using Air IDEAL®3P™ Traceability
Description
Air IDEAL®3P™ Traceability is supplied in a carrying case. Inside the case is a rigid lid
which can be used as a small work surface [dimensions 22.7 x 13.9 cm
(8.9 in. x 5.4 in.)].
The instrument is available in two versions:
− for 90 mm agar plates (product no. 410175)
− for 65/70 mm agar plates Count-Tact
∗ For each product number, please refer to the packing list provided with the instrument.
®
(product no. 410174)
∗ Accessories:
− 65/70 mm Count-Tact diameter additional sampling grid (product No. 96304).
− 90 mm diameter additional sampling grid (product No. 96309).
− Aluminum telescopic tripod with ball joint (product No. 96308).
− Sterile box for transport and incubation of 65/70 mm Count-Tact plates – Kit of 10
− Sterile box for transport and incubation of 90 mm plates – Kit of 10
Figure 3-1: Air IDEAL®3P™ Traceability in its carrying case
(product No. 96301).
*
(product No. 96311
).
*
Availability: consult bioMérieux
Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual 3-1
Using Air IDEAL®3P™ Traceability
Description
Consumables
Air IDEAL®3P™ Traceability is adapted to all types of Petri dishes available on the market:
65, 70 and 90 mm.
Moreover, the use of a large range of ready-to-use culture media – irradiated or classic –
developed and manufactured by bioMérieux, the reference in this field, enables you to
obtain the best possible performance from the instrument.
The media comply with specific industrial and hospital environmental controls.
Culture media for general use
− TSA 20 x 90 mm plates (product No. 43011) / GTS 100 x 90 mm plates (product no.
43019)
− PCA agar 20 x 90 mm plates (product no. 43558)
− Sabouraud Dextrose agar 20 x 90 mm plates (product no. 43555)
− Sabouraud Dextrose Chloramphenicol agar 20 x 90 mm plates (product no. 43596)
− Count-Tact
− Count-Tact TSA agar 20 x 65 mm plates (product no. 43582)
− Count-Tact Sabouraud Dextrose Chloramphenicol agar 20 x 65 mm plates (product no.
43580)
®
agar 20 x 65 mm plates (product no. 43501)
Irradiated media
− Irradiated GTS 3P agar 20 x 90 mm plates (product no. 43711)
− Irradiated GTS 3P agar 100 x 90 mm plates (product no. 43169)
− Irradiated GTS 3P agar with neutralizers 20 plates (product no. 43811)
− Irradiated GTS 3P agar with neutralizers 100 plates (product no. 43819)
− Irradiated Count-Tact 3P agar 20 x 65 mm plates (product no. 43691)
− Irradiated Count-Tact 3P agar 100 x 65 mm plates (product no. 43699)
− irradiated Sabouraud Dextrose agar 20 x 90 mm plates (product no. 43554)
− Irradiated Sabouraud Dextrose 3P agar with neutralizers 20 plates (product no. 43814)
− Irradiated Sabouraud Dextrose Chloramphenicol agar 20 x 90 mm plates (product no.
43595)
− Irradiated Count-Tact Sabouraud Dextrose 3P agar with neutralizers 20 plates (product
no. 43812)
− Irradiated Count-Tact Sabouraud Dextrose Chloramphenicol agar with neutralizers 20 x
65 mm plates (product no. 43581)
Identification of the instrument
Figure 3-2: Identification of the instrument
3-2 Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual
Air outlet
Handle
Threading
for tripod
Jack socket
Front face of the Air IDEAL®3P™ Traceability
Figure 3-3: Front face
Using Air IDEAL®3P™ Traceability
Description
Rear face of the Air IDEAL®3P™ Traceability
Figure 3-4: Rear face
Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual 3-3
Using Air IDEAL®3P™ Traceability
Sampling grid for 65 or 70 mm Petri dishes
Sampling grid for 90 mm Petri dishes
65 or 70 mm (Count-Tact ®) Petri dish
90 mm Petri dish
Sampling grid
Keypad
Figure 3-5: Keypad
Sampling grid
Configuration for 65, 70 or 90 mm Petri dishes
Figure 3-6: Diameter of Petri dishes
3-4 Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual
Stainless steel strip for
Aspiration orifice
attachment
Seal
Using Air IDEAL®3P™ Traceability
Sampling grid
Figure 3-7: Sampling head– 65, 70 or 90 mm Petri dishes
Tripod assembly
Figure 3-8: Tripod assembly
Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual 3-5
Using Air IDEAL®3P™ Traceability
General specifications
General specifications
Environmental conditions
Normal storage conditions ................................................................................ -20° to + 50°C
Inside use in an air class zone, sterile room or glove box.
Normal conditions of use ............................................................. 0 to 40 °C (32 °F to 104 °F)
Relative humidity ...................................................................................................... 0 to 95%
Maximum installation altitude ................................................................................... < 2 000 m
Standards applicable ........................................................................... See product certificate
The instrument must be transported in its specific case.
Physical features
Dimensions
Instrument alone Instrument in its case
Height 128 mm
Width 146 mm
Depth 208 mm
Mass
Instrument alone Instrument in its case Shipping carton
≈ 1.2 kg ≈ 5.5 kg ≈ 7.1 kg
Materials
ABS/Polycarbonate shell
Polycarbonate keypad
PVDF sampling grid
Stainless steel mounting strips and screws
Elastomer jack protection caps
(5.03 in.) 301 mm (11.8 in.)
(5.75 in.) 250 mm (9.84 in.)
(8.18 in.) 400 mm (15.75 in.)
Characteristics of materials
− Shock resistance: shell and keypad.
− Chemical resistance: to most standard disinfectants (70% isopropanol, hydrogen
peroxide, 70% ethanol, quaternary ammoniums).
− Thermal resistance: sampling grid that can be autoclaved using Good Sterilization
Practices, see section "Sterilization of grids" on page 5-1.
Note: With increasing numbers of autoclaving cycles, the grids become increasingly yellow-gray, but this has
no effect on grid performance.
− Surface finish: Ra coefficient of grid = 0.14 micron.
− Fire resistance: ABS/POLYCARBONATE V0 shell (highest grade of fire resistance).
3-6 Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual
Technical characteristics
Keypad Key control.
Display Liquid crystal display (2 x 16 characters).
Sampling grid 1/8-turn screw-on sampling grid.
Possibility of sampling on 90 mm 65/70 mm diameter Petri dishes (specific sampling grids
and fixing strips).
User interface Air IDEAL
• Slave mode: using Air IDEAL
• Manual mode: autonomous operation using the keypad.
®
3P™ Traceability can operate in 2 modes:
®
3P™ Traceability with the RUID.
− 5 buttons for access to all Air IDEAL
An LCD screen is used to program the instrument and follow its operation. Messages are in
English.
− Additional information on instrument operation is given as audible signals.
A flashing indicator light indicates, from a distance, the status of the instrument:
− Green flashing indicator light: sampling in progress. The indicator light changes to
constant green when sampling is performed successfully. In slave mode the green
indicator light continues to flash until sampling is stopped using the RUID.
− Slow flashing green indicator light: the battery is charging. The indicator light changes to
constant green as soon as the battery has been fully charged.
− Constant green indicator light: the instrument is powered on and ready to start sampling
in manual or slave mode.
− Flashing green/red indicator light: the battery is low.
− Flashing or constant red indicator light: a problem has occurred.
− Indicator light off: the instrument is powered off.
Using Air IDEAL®3P™ Traceability
®
3P™ Traceability functions.
General specifications
Language used for the software: English
Ergonomics Ergonomic handle (right hand/left hand).
Possibility of stable sampling with the unit in four positions (see page 3-11).
®
Possibility of suspending Air IDEAL
3P™ Traceability with a hook, especially in a glove
box.
Optionally, the instrument can be mounted on a telescopic tripod equipped with a ball joint
enabling the sampling axis to be orientated through an angle of 0° to 90° (from horizontal to
vertical), and its height to be adjusted (between 0.7 and 2.50 meters).
Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual 3-7
Using Air IDEAL®3P™ Traceability
General specifications
Electrical characteristics
Voltage........................................................................................................... 7.4 VDC nominal
Power supply .............................................................................................................. 1 A max.
®
Air IDEAL
3P™ Traceability is designed to run on a battery (2 Lithium-ion batteries
connected in series, each with a nominal voltage of 3.7 V).
The instrument can also be powered and/or recharged using one of the adapters indicated
or an equivalent one.
CAUTION! The AC-DC power supply adapter must have the following characteristics:
- Voltage: 12 VDC
- Power: 2 A max.
- Plug mod. Jack 12.0 x 2.1 mm
- AC input voltage corresponding to the characteristics of the power supply in the
country where the instrument is installed.
Note: It is recommended to use the adapter provided with the instrument. You will find the details of its
characteristics below.
POWER SUPPLY complying with - UL/CSA standards
INPUT 100 – 240 VAC 0.7 A – 0.4 A 47 – 63 Hz
UL STD plug or STD European plug
OUTPUT 12 VDC 2 A max.
d = 2.1 mm JACK plug
Functional specifications
Flow- rate 100 ± 6.4 liters per minute regardless of the grid used.
Flow-rate measured and adjusted according to the bioMérieux quality control protocol
reference 96302-protocol.
Autonomy More than or equal to 4 hours, enabling at least 24 consecutive 1000 liter samples to be
collected.
Specification valid for a new battery not having undergone a thermal shock or a prolonged
period of inactivity.
Charge time It takes 3 hours to fully charge the battery.
Sound level < 50 dB
Security Male plug outlet serves as the power supply sectioning device.
3-8 Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual
Using Air IDEAL®3P™ Traceability
•
•
•
•
Unpacking Air IDEAL®3P™ Traceability
Unpacking Air IDEAL®3P™ Traceability
The instrument is supplied in a carrying case and box.
∗ When opening the box:
• Make sure you have all the items described in the packing list.
• Keep the shipping carton in case you need to ship the instrument back to bioMérieux.
CAUTION! Any damage directly or indirectly resulting from the transport of the instrument
without adequate containers will not be covered by the warranty or maintenance
contract.
DANGER! Do not use the instrument in an explosive atmosphere as sparks could cause an
explosion.
Recommendations for installation and use
• Install the instrument on a flat, perfectly horizontal surface, on its tripod or by its hook.
• Avoid locations directly exposed to sunlight, excessive heat, damp or dust.
• The instrument must not be used near strong sources of electromagnetic interference.
• Do not use the instrument with its original protective cover cap, but with a grid.
IMPORTANT! When the instrument is used for the first time, it is imperative to perform 1 battery
charge-discharge cycle.
Charge the battery for 3 hours.
Discharge the battery by performing successive sampling
(see page 3-25 "Battery autonomy test (Menu 6)").
Recharge for 3 hours.
Make sure the grid holes are not blocked.
Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual 3-9
Using Air IDEAL®3P™ Traceability
Recommendations for installation and use
WARNING! The user’s manual or instruction manual for an intentional or unintentional radiator
shall caution the user that changes or modifications not expressly approved by the
party responsible for compliance could void the user’s authority to operate the
equipment.
In cases where the manual is provided only in a form other than paper, such as on a
computer disk or over the Internet, the information required by this section may be
included in the manual in that alternative form, provided the user can reasonably be
expected to have the capability to access information in that form.
This equipment has been tested and found to comply with the limits for a Class B
digital device, pursuant to part 15 of the FCC Rules. These limits are designed to
provide reasonable protection against harmful interference in a residential
installation. This equipment generates, uses and can radiate radio frequency energy
and, if not installed and used in accordance with the instructions, may cause harmful
interference to radio communications. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment does cause
harmful interference to radio or television reception, which can be determined by
turning the equipment off and on, the user is encouraged to try to correct interference
by one or more of the following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment
n outlet on a different circuit to the one to which the
to a
receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.
WARNING! I
ndustry Canada requirements:
RSS-Gen - General Requirements and Information for the Certification of Radio
Apparatus, Clause 7.1.2 statement:
Under Industry Canada regulations, this radio transmitter may only operate using an
antenna of a type and maximum (or lesser) gain approved for the transmitter by
Industry Canada. To reduce potential radio interference to other users, the antenna
type and its gain should be so chosen that the equivalent isotropically radiated power
(e.i.r.p.) is not more than that necessary for successful communication.
RSS-Gen - General Requirements and Information for the Certification of Radio
Apparatus, Clause 7.1.3 statement:
This device complies with Industry Canada licence-exempt RSS standard(s).
Operation is subject to the following two conditions: (1) this device may not cause
interference, and (2) this device must accept any interference, including interference
that may cause undesired operation of the device.
This device complies with FCC and Industry Canada RF radiation exposure limits set
forth for general population (uncontrolled exposure). This device must not be
collocated or operating in conjunction with any other antenna or transmitter.
3-10 Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual
Sampling positions
Using Air IDEAL®3P™ Traceability
Sampling positions
IMPORTANT! Air IDEAL
during decontamination phases. Even though sampling can be done while
suspended, it is preferable to position the instrument along the axis of one-way flow
at the air outlets. This configuration is the worst case scenario since the air sampled
has swept the entire volume of the glove box before emerging.
Do not obstruct the air outlet during use to respect operating parameters.
Figure 3-9: Sampling positions
®
3P™ Traceability is delivered with a hook for suspending it in a glove box
Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual 3-11
Using Air IDEAL®3P™ Traceability
Screwing on the sampling grid
Screwing on the sampling grid
CAUTION! Do not insert any foreign objects into the aspiration orifice located under the grid (see
page 3-5).
∗ To screw on the sampling grid easily,
• Position the grid on the threading of the shell and turn it clockwise by 1/8 of a turn
without forcing or pressing.
Electrical power supply
Air IDEAL®3P™ Traceability operates self-sufficiently through a Lithium-ion battery pack.
It can also run off the mains using the charger/adapter.
Operation on the battery
The microprocessor manages and displays the available battery life at all times, on the basis
of a theoretical autonomy of 4 hours for sampling cycles of 1000 liters.
As soon as the flashing symbol appears , there are 20 minutes of autonomous running
remaining.
Immediately put the battery on charge; if a sampling cycle is in progress it will be completed
just the same.
A sampling cycle cannot start if its duration exceeds the remaining battery life displayed.
Figure 3-10: Screwing on the sampling grid
3-12 Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual
Low battery signals
IMPORTANT! In slave mode, if the battery is low at the beginning of an analysis, the operator is
Charging
Using Air IDEAL®3P™ Traceability
Electrical power supply
∗ When the battery life has expired, the following low battery signals are output:
Visual signal on the welcome message display:
Flashing symbol
Visual signal on the sample in progress display:
Flashing symbol
Audible signal when the instrument is turned on: 2 long beeps emitted each time the
instrument is powered on.
warned by a message displayed on the RUID (please refer to the remote control user
manual).
∗ To charge the battery,
• Use the charger supplied or one with the same specifications.
• During the charging phase, the instrument can be either switched on or switched off.
• Connect the charger to the instrument jack connector after removing the protection cap.
• Connect the charger to the power outlet.
The display indicates:
The normal time required to completely charge a discharged battery pack is 3 hours.
During the charging phase, it is possible to perform sampling with Air IDEAL®3P™
Traceability running off the mains. The charging process will be suspended during sampling
and will restart automatically when sampling is finished.
IMPORTANT! During sampling with Air IDEAL®3P™ Traceability running off the mains, do not
disconnect the instrument from the mains as there is a risk of it switching off and the
sampling cycle in progress would be definitively lost.
Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual 3-13
Using Air IDEAL®3P™ Traceability
Electrical power supply
∗ At the end of the operation,
• Disconnect the charger from the power outlet.
• Disconnect the charger from the the instrument jack connector.
• Install the protection cap.
• Check that the battery life displayed is again 4 hours.
IMPORTANT! If Air IDEAL®3P™ Traceability is not used for more than 10 days, the battery must be
totally recharged (3 hours).
Operation using mains power
Connection to the mains is carried out in the same way as for charging the battery.
The display indicates:
• Press the <START> or <MENU> button to return to the welcome message.
Then
• Press the <START> button to start (the volume sampled will be the last recorded).
or,
• Select the sample volume by means of MENU 1 or MENU 2, and then start by pressing
<START> button.
the
∗ To turn off,
IMPORTANT! During sampling with Air IDEAL®3P™ Traceability running off the mains, do not
Automatic standby
Automatic switch off
• Disconnect the charger from the Jack socket on the instrument.
disconnect the instrument from the mains as there is a risk of it switching off and the
sampling cycle in progress would be definitively lost.
To preserve the battery life, the instrument automatically goes into standby mode after 5
minutes of inactivity.
Pressing any key will reactivate the instrument.
The RUID can activate the instrument so that it is ready for sampling.
In manual or slave mode, the instrument switches off after 1 hour of inactivity.
While it is switched off, Air IDEAL®3P™ Traceability cannot communicate with a RUID.
3-14 Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual
Operation in slave mode
− In slave mode, the Air IDEAL®3P™ Traceability is used with a RUID.
− Please refer to the RUID User Manual.
Operation in manual mode
In manual mode the Air IDEAL®3P™ Traceability operates autonomously.
Programming
Air IDEAL®3P™ Traceability enables sampling to be programmed and monitored.
This section describes how to program the instrument.
Programming characteristics
− Sample volumes adjustable from 5 to 10 liters in 1-liter steps.
− Sample volumes adjustable from 10 to 2000 liters in 10-liter steps.
− Automatic selection of last sample volume used.
− Storage of 4 sample volumes in the memory.
− Delayed start-up (maximum 60 minutes).
• 0 to 60 seconds in 1-second steps
• 1 minute to 60 minutes in 1-minute steps
− Sequenced sampling.
Using Air IDEAL®3P™ Traceability
Operation in slave mode
Sampling controls
− Volume counter.
− Volume of air sampled remains on display after sampling is interrupted.
− Sampling status is indicated by an indicator light.
− Possibility of interrupting and resuming a sample in progress (only in manual mode).
− End of sample buzzer (6 short beeps).
− Count-down of time.
Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual 3-15
Using Air IDEAL®3P™ Traceability
Operation in manual mode
Air IDEAL®3P™ Traceability menus
Turning on.
WELCOME
MESSAGE
MENU 1:
MENU 2: Programming 1 sample volume not in memory.
MENU 3: Modification of the 4 pre-programmed sample volumes.
MENU 4: Programming delayed start-up.
Last sample taken.
Remaining autonomy.
Selection of one of 4 sample volumes among the 4 volumes preprogrammed in menu 3.
MENU 5: Programming sequenced sampling.
MENU 6: Battery autonomy test.
Turning off.
3-16 Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual
Turning on Air IDEAL®3P™ Traceability
∗ To turn on the instrument,
• Press <ON/OFF>.
The display indicates:
Using Air IDEAL®3P™ Traceability
Operation in manual mode
Note: The
− ZZZL corresponds to the last sample volume recorded.
−
∗ If the symbol
• Recharge the instrument.
symbol is displayed if a delayed start-up is programmed.
XHXX corresponds to remaining battery life.
appears:
∗ If the last sample did not terminate correctly (sampling stopped before the end, protection
cap in place of the grid, motor blocked),
AND
∗ If the instrument is then switched off or put on standby,
The following message will appear when the instrument is switched on again or is
reactivated:
In this case, press <MENU> once to display the welcome message.
DANGER! Do not insert any foreign objects into the motor compartment when the instrument
is running.
Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual 3-17
Using Air IDEAL®3P™ Traceability
∗
Operation in manual mode
Standby
To put the instrument on standby,
• Briefly press <ON/OFF>, the indicator light must not go off.
or
• Wait for 5 minutes.
∗ To reactivate the instrument,
• Press any key.
Turning off Air IDEAL®3P™ Traceability
∗ To turn off the instrument,
• Press <ON/OFF> until the indicator light goes off.
Selection of one of the 4 pre- programmed sample volumes (Menu 1)
∗ Factory programming memorizes the following 4 volumes in Air IDEAL
100, 500, 1000, 2000 liters.
∗ To select menu 1,
• Press <MENU>.
The display indicates:
• Press the < + > button to select 1 of the 4 volumes memorized.
®
3P™ Traceability:
3-18 Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual
Using Air IDEAL®3P™ Traceability
Operation in manual mode
Example:
∗ To select stored volume No. 2 from menu 1,
• Press < + > twice.
• Wait 2 seconds.
Note: If you did not wait for the end of the first timeout, in other words if you pressed another button before the
2 seconds, the new value selected (
YYY) is not recorded. The initial value (ZZZ) remains in memory.
The value YYY selected is recorded.
The display indicates:
∗ There are 3 possibilities:
• Start sampling immediately by pressing the <START> button.
• Wait: the selected sampling can be started at a later time.
• Press the <ON/OFF> button to turn off the instrument. The volume selected will be
displayed the next time it is turned on.
Programming a sample volume not in memory (Menu 2)
∗ To select menu 2,
• Press <MENU> twice.
The display indicates:
Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual 3-19
Using Air IDEAL®3P™ Traceability
Operation in manual mode
∗ To program a new volume,
• Press < + > or < - > until the desired volume is displayed.
IMPORTANT! It is imperative to press the
volume.
< + > or < - > buttons immediately to program a new
After a 2-second delay, the volume displayed is recorded.
The display indicates:
∗ There are 3 possibilities:
• Start sampling immediately by pressing <START>.
• Wait: the selected sampling can be started at a later time.
• Press the <ON/OFF> button to turn off the instrument. The volume selected will be
displayed the next time it is turned on.
Modification of the 4 pre- programmed sample volumes (Menu 3)
∗ To select menu 3,
• Press <MENU> 3 times.
The display indicates:
• Wait 2 seconds.
The display indicates:
3-20 Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual
Using Air IDEAL®3P™ Traceability
Operation in manual mode
∗ To program a new volume for program 1,
• Press < + > or < - > until the desired volume is displayed.
IMPORTANT! It is imperative to press the
volume.
After a 2-second delay, the volume displayed is recorded.
The display indicates:
Note: If the <MENU>, < + > or < - >, buttons are not pressed, each of the 4 pre-programmed volumes is
displayed every 2 seconds.
< + > or < - > buttons immediately to program a new
∗ To program a new volume for program 2,
• Press < + > or < - > until the desired volume is displayed.
IMPORTANT! It is imperative to press the
volume.
After a 2-second delay, the volume displayed is recorded.
The display indicates:
< + > or < - > buttons immediately to program a new
∗ To program a new volume for program 3,
• Press < + > or < - > until the desired volume is displayed.
IMPORTANT! It is imperative to press the
volume.
After a 2-second delay, the volume displayed is recorded.
The display indicates:
< + > or < - > buttons immediately to program a new
Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual 3-21
Using Air IDEAL®3P™ Traceability
Operation in manual mode
∗ To program a new volume for program 4,
• Press < + > or < - > until the desired volume is displayed.
IMPORTANT! It is imperative to press the
volume.
After a 2-second delay, the volume displayed is recorded.
The display indicates:
The screen the returns to the welcome message.
Note: If the < + > or < - > buttons are not pressed, the pre-programmed volumes are sequentially displayed
without modification.
< + > or < - > buttons immediately to program a new
∗ Possibility of going directly to "MENU 4", once selected volumes are modified:
When "END" is displayed on the screen,
• Immediately press <MENU>.
Menu 4 is displayed.
Programming delayed start- up (Menu 4)
∗ Delayed start-up can be programmed for up to 60 minutes:
− 0 to 60 seconds in 1-second steps
− 1 minute to 60 minutes in 1-minute steps.
∗ To select menu 4,
• Press <MENU> 4 times.
The display indicates:
3-22 Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual
Using Air IDEAL®3P™ Traceability
Operation in manual mode
∗ To program a delay value,
• Press < + > or < - > until the desired delay value is displayed.
IMPORTANT! It is imperative to immediately press
After 2-seconds, the delay value is recorded.
The display indicates:
The screen returns to the welcome message.
The delay is recorded: the symbol
∗ There are 3 possibilities:
• Start sampling immediately by pressing <START>.
• Wait: the selected sampling can be started at a later time.
• Press the <ON/OFF> button to turn of the instrument. The volume selected will be
displayed the next time it is turned on.
< + > or < - > to program a new volume.
appears in the welcome message.
Programming sequenced sampling (Menu 5)
Menu 5 is used to sample a selected volume several times.
∗ This sequencing is defined with 3 parameters:
− The unit volume (of each sequence).
This volume is defined with menus 1 or 2 (see pages 3-18 and 3-19).
− The number of sequences.
This number is included between 2 and 5.
− The time interval between each sequence.
It is included between 10 minutes and 4 hours, in 10-minute steps.
Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual 3-23
Using Air IDEAL®3P™ Traceability
Operation in manual mode
∗ Total sampling time must be less than 5 hours otherwise an error message will appear.
∗ To select menu 5,
• Press <MENU> 5 times.
The following message appears and the 1st line flashes:
The unit volume is shown on the lower left and cannot be modified in this menu.
∗ To modify the number of sequences,
• Press < + > or < - > until the desired number is displayed.
• Press <MENU> once the number of sequences is selected.
INTXHXX" (INTERVAL) field flashes.
The "
• Press < + > or < - > to define the time interval between each sequence.
IMPORTANT! Check that the remaining battery life is sufficient to carry out complete sampling
(base: 10 min/1000 liters).
∗ Once sequenced sampling has been correctly programmed,
• Press the <START> button to start sampling.
The total duration of sequences and intervals must not exceed 5 hours otherwise an error
message will appear:
• Press <MENU> to return to menu 5.
Correct the settings (number of sequences / delay) so that sampling can be performed.
IMPORTANT! A sequenced sampling is run from the specific menu, without returning to the main
menu.
If the last sampling was sequenced, the menu 5 screen is displayed when the
instrument is turned on.
3-24 Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual
∗
Battery autonomy test (Menu 6)
This menu is used to verify that the battery is still compliant with specifications of new
material (battery life ≥ 4 hours).
The battery autonomy test can be performed using a volume chosen by the operator.
1000 liters is the reference volume for verifying that specifications have been respected
(4 hours of battery life for 1000-liter samples).
If the volume generally used is, for example, 100 liters, then it is wiser to perform the test on
100 liter volumes.
∗ To check battery life:
− Note the battery life displayed when the instrument is turned on.
− Using Menu 1, select a 1000 liter sample volume.
− Go to Menu 6.
To select menu 6,
• Press <MENU> 7 times.
The display indicates:
Using Air IDEAL®3P™ Traceability
Operation in manual mode
• Press the <START> button to run the battery discharge cycle.
∗ The battery discharge cycle can be stopped as follows:
• Press <STOP>.
∗ To resume at a later time,
• Press <START>.
CAUTION! After more than 5 minutes of inactivity, Air IDEAL
To turn it back on, press .
®
3P™ Traceability turns off.
Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual 3-25
Using Air IDEAL®3P™ Traceability
Starting sampling
Starting sampling
CAUTION! Before starting, check that Air IDEAL®3P™ Traceability is fitted with a sampling grid
and not its protective cover otherwise it could undergo irreversible damage which is
not covered by the bioMérieux warranty.
∗ If the protective cover remains on the instrument, the following alarm message is displayed
after several seconds and sampling stops automatically:
The indicator light flashes red.
• Remove the protection cover.
• Install the grid.
• Press <MENU> to return to the welcome message.
∗ To start sampling,
• Turn on the instrument,
• Press <ON/OFF>.
The indicator light is constant green and the following message appears:
• Press <START/STOP>.
∗ During sampling, the display indicates:
The indicator light changes to flashing green.
The
SAMPLE VOL display flashes during the sampling phase and the volume counter is
displayed.
− The last sample volume recorded is automatically displayed (shown as ZZZL).
3-26 Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual
Using Air IDEAL®3P™ Traceability
Starting sampling
− A buzzer indicates the end of sampling (6 short buzzes) and the display returns to the
original message with automatic correction of the remaining battery life.
The indicator light changes to constant green. The instrument is free to perform a new
sampling cycle.
∗ If a delayed start-up has been programmed, the display indicates:
TIMED flashes during the count-down phase.
Note: The motor stops 2 liters before the total volume has been sampled.
∗ Last sampling not terminated:
If the instrument was turned off during sampling, the following message appears the next
time the instrument is turned on:
The indicator light changes to flashing red.
CAUTION! In this case, the user must take all necessary precautions to deal with this interrupted
sampling.
• Press <MENU> to return to the welcome message.
Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual 3-27
Using Air IDEAL®3P™ Traceability
Starting sampling
Stopping the motor
• Press <START/STOP>.
Note: It is always possible to stop a sampling operation in progress by pressing <START/STOP>.
If the motor is stopped during the program, i.e. during the delayed start-up count-down
phase or during the sampling phase, the value displayed freezes and the display continues
to flash.
∗ To resume sampling,
• Press <START/STOP>.
If the motor is restarted after being stopped during a program, the program will resume from
the point where it was stopped.
Note: If stoppage during sampling is more than 5 minutes, the instrument will go into standby mode and the
sampling program will not be able to resume.
3-28 Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual
Using Air IDEAL®3P™ Traceability
Setting Air IDEAL®3P™ Traceability parameters (summary diagram)
Setting Air IDEAL®3P™ Traceability parameters (summary
diagram)
1 x
Menu 1: Selection of one of
the 4 sampling volumes
among the 4 pre-programmed
volumes.
Press < + > or < - > until the
desired volume in memory is
displayed.
("Preset volume")
2 x
Menu 2: Selection of a
sampling volume not in
memory.
Press < + > or < - > until the
desired volume is displayed.
("CHOSEN VOLUME")
4 x
3 x
Menu 3: Modification of the 4
pre-programmed sampling
volumes.
PROGRAM 1, 2, 3 and 4
Press < + > or < - > until the
chosen volume is displayed.
Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual 3-29
Using Air IDEAL®3P™ Traceability
Setting Air IDEAL®3P™ Traceability parameters (summary diagram)
Select delay before starting
4 x
Menu 4 : Programming
delayed start-up.
Press < + > or < - > until the
delay value is displayed.
5 x
Menu 5 : Programming
sequenced samplings.
Press < + > or < - > until the
desired number is displayed.
1 x
6 x
Menu 6 : Battery autonomy
Select number of
sequences
test.
Press < + > or < - > until the
desired time is displayed.
Select time between
sequences
3-30 Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual
STORED VOL: ZZZL
BATTERYLIFE
NEXT CALIBRATION
FSE (Field Service
RUID Serial
MAC ADRESS
FREE MEMORY
Soft Version
LAST CALIBRATION
Serial number
FRMB Serial
M aintenance Menu
Navigation using < + > and< - > keys
:XHXX
XXXX
XXXXYXXXXYXX
MM/DD/YYYY
XXXX WORDS
Using Air IDEAL®3P™ Traceability
Engineer) XXXXXX
X.X
Maintenance Menu
XXXXXXXXX
XX
MM/DD/YYYY
IMPORTANT! This information can be viewed by the user, but it can only be updated by bioMérieux
Technical Assistance or the local bioMérieux representative.
Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual 3-31
Using Air IDEAL®3P™ Traceability
Maintenance Menu
Welcome message
Date of next calibration (Month/Day/Year)
ID of operator who performed calibration
Serial number of RUID used for calibration
Flow Rate Measurement Bench serial number
Date of last calibration
Air IDEAL
Air IDEAL®3P™ Traceability available memory size
MAC address (Media Access Control)
Air IDEAL®3P™ Traceability serial number
®
3P™ Traceability firmware version
Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual 3-32
4 Procedure
Principle
Implementation and following of a procedure to measure aerobiocontamination corresponds
to a process based on prevention, which involves:
• Evaluating the current level and standard of hygiene and controls.
• Selecting the critical areas to be controlled.
• Establishing a reference level and an alert level for each of the critical points.
• Developing a sampling plan.
• In manual mode, preparing a document for recording air sampling results.
• In slave mode, recording of air sampling results using the RUID.
• Preparing a plan for corrective action in case of deviation.
The result of sampling should provide information on the level of risk, global hygiene
conditions and environment.
Procedure
The procedure must be adapted to the actual conditions in which air sampling will take place
(contaminated areas, clean areas, sterile areas, etc.)
When strictly followed, the procedure guarantees good quality sampling and should include:
− Operators’ qualifications.
− Names of qualified operators.
− Hygiene of operators (clothes, hands, etc.).
− Protocol for disinfection of the AeroBioCollector.
− Detailed steps of the procedure.
Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual 4-1
Procedure
How to obtain a good quality sample
How to obtain a good quality sample
Precautions of use
• Check the condition of the instrument and sampling grid.
• When unscrewing and screwing on the sampling grid, avoid touching the perforated
zone.
The choice of medium depends on the area to be controlled and the type of micro-organism
to be isolated.
The agar in 90 mm Petri dishes, must be at least 2.5 mm thick at the center and have a flat
surface. It should not present dehydration or humidity droplets.
• During sampling, avoid any unnecessary movement, do not pass in front of the
instrument or cough etc.
• Begin by collecting from low contaminated areas.
• Collect several samples in each zone in order to obtain results that can be used for
statistical studies.
• Clean the instrument after use and sterilize sampling grids.
• Recharge the battery if necessary.
• Place the instrument in its carrying case and store it in a suitable place.
Sampling in manual mode
Note: For slave mode, please refer to the RUID User Manual.
Turn on the instrument.
•
• Check the remaining battery life.
• Place the instrument on a flat surface (work bench, table, etc.) in a vertical or horizontal
position, or set it up on its tripod.
• Select the sample volume according to the critical area to be controlled.
• Remove the protective cover or the sampling grid.
• Record the date, time and sample location on the Petri dish.
• Place the Petri dish with its cover between the attachment clips and make sure it is
correctly positioned.
• Remove the Petri dish cover and place it on a clean surface.
• Screw on the sampling grid corresponding to the type of plate used.
• Perform sampling.
• The instrument indicates the end of sampling (6 beeps and a constant green indicator
light).
• Unscrew the sampling grid.
• Carefully remove the Petri dish without touching the agar.
• Put the cover back on the Petri dish used.
• Put the protective cover back on.
Incubation and reading
The Petri dishes must be placed in the incubator as rapidly as possible.
After incubation, read as follows:
− Count the number of CFU (Colony Forming Units) which have grown and refer to the
reading table for the final result (see page 7-1).
− If results are not acceptable, proceed with colony identification to orientate corrective
action.
4-2 Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual
Sampling plan
The sampling plan must be drawn up very carefully and followed strictly. The aim is to
guarantee that the values obtained are comparable. Any discrepancy between values
should reveal a variation in aerobiocontamination.
A sampling plan must include:
− the critical points to be controlled
− the following must be mentioned for each point controlled:
• the time and frequency,
• the micro-organism(s) to be isolated,
• the media used,
• the revivification conditions,
• the sample volume,
• the number of samples per area controlled,
• the reference level and the alert level,
In practice, the alert level can be fixed at 3 times the reference level.
• sampling conditions (temperature, hygrometry, staff numbers, activity, etc.).
Recording and evaluating results
Procedure
Sampling plan
The person in charge of controlling the quality of air collects the results recorded.
− Results which give expected values are validated.
− If unacceptable results are obtained, corrective action may be necessary.
The document for recording results must include:
− date and time of sample,
− operator’s name,
− critical point controlled,
− the situation of the control in relation to the activity (production cycle, pre or post-
operative, etc.),
− detailed stages of the procedure,
− level of internal activity (number of people present, number of lines running, etc.),
− thermohygrometric conditions (real or reference),
− micro-organism to be isolated,
− culture medium used,
− incubation conditions (duration, temperature),
− date and time of incubation,
− date and time of reading,
− reference level and alert level,
− result: acceptable/unacceptable,
− decision: validation/ corrective action.
Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual 4-3
5 Maintenance
Preventive maintenance
CAUTION! No preventive maintenance needs to be performed by the user.
If an anomaly occurs on your instrument, call bioMérieux or your local distributor. Do
not open the shell of the instrument.
Always use a replacement battery of the same type (Li-on 7.4 V – 4.4 to 5Ah) to avoid the
risk of explosion.
Used batteries must be returned to bioMérieux or your local distributor.
Routine servicing
The routine servicing operations to be carried out by the user are:
− Battery charging.
− Cleaning and disinfection.
− Sampling grid sterilization.
Cleaning and decontamination procedure
All parts, including the case (inside and outside), can be cleaned with soapy water, rinsed
and dried.
The stainless steel strip for attachment of Petri dishes can be dismantled for cleaning.
IMPORTANT! Do not use concentrated peracetic acid, acetone or chlorinated solvents (chloroform,
etc.) on the shell or keyboard.
Sterilization of grids
Air IDEAL®3P™ Traceability is delivered with a set of 5 grids. They can be sterilized by
autoclaving at 134°C for 18 min.
bioMérieux has validated that the grid specifications and performance are not altered after
autoclaving up to:
• 40 times at 134°C for 18 minutes
• 200 times at 121°C for 20 minutes
After autoclaving 14 times or more, the grid may begin to turn yellow and may become
difficult to screw onto the instrument.
IMPORTANT! Do not sterilize under a flame.
Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual 5-1
Maintenance
Routine servicing
Decontamination of external parts
All the external parts of the instrument can be decontaminated with most of the usual
disinfectants at the usual effective concentration (70% isopropanol, hydrogen peroxide, 70%
ethanol, quaternary ammonium).
Decontamination of the air circuit
Decontamination of the instrument according to this protocol with ClearKlens IPA (Johnson
Diversey) has been validated by bioMérieux. A summary of this validation is available on
request.
∗ Decontamination protocol:
• Spray twice with 70% isopropyl alcohol with the motor off: one spray at the air inlet, the
other at the outlet.
• Allow to react for 15 minutes before using the instrument.
Decontamination in a glove box
Air IDEAL®3P™ Traceability was specially developed for use in production or control glove
boxes. The suitability of this instrument for use in glove boxes was evaluated by the SKAN
AG "Center of Competence for Isolator Technology".
∗ Two parameters were tested:
− The capacity of the instrument to withstand standard decontamination cycles in glove
boxes.
− The capacity of a standard decontamination cycle to disinfect the different types of
materials that compose the instrument.
• A summary of this validation is available on request.
Airflow control
IMPORTANT! The airflow control must be performed by bioMérieux Technical Assistance or the
The airflow control must be performed once a year from the date of the last control or
adjustment.
local bioMérieux representative.
5-2 Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual
supplier.
6 Troubleshooting
Indicator light
status
Flashing red
Error message Possible cause
LAST SAMPLING
NOT
COMPLETED
LAST SAMPLING
NOT
COMPLETED
ERROR
BATTERYLIFE
ERROR TIME >
5H
Flashing volume
is displayed
Sampling is
interrupted in
MANUAL mode.
Sampling is
interrupted in
SLAVE mode.
There is insufficient
battery life to
perform the
sampling program.
The total duration
of sequenced
samplings
programmed in
MENU 5 has
exceeded 5 hours.
Sampling has been
accidentally
interrupted by the
operator.
Press <MENU> to return to
the welcome message.
N/A Acknowledge the fault on the
Connect the instrument to the
mains power so that sampling
can start or put the battery on
charge.
Reprogram so that the total
duration does not exceed 5
hours.
To continue sampling, press
<START>. The volume collected
will flash on the display.
To stop sampling, press
<STOP>.
Action
in MANUAL mode
Action
in SLAVE mode
Press <MENU> to return to
the welcome message.
RUID and stop the sampling
cycle with the RUID that was
used to start it.
If this RUID is not
available, press <MENU> for
10 seconds on the instrument
and then select "Yes" to return
to the welcome message.
Acknowledge the fault on the
RUID and then connect the
instrument to the mains so
that sampling can start, or to
charge the battery.
Not applicable as the fault is
detected when the sampling
campaign is programmed on
the PC application.
Acknowledge the fault on the
RUID and then close the
sampling cycle with the RUID
that was used to start it.
If this RUID is not
available, press <MENU> for
10 seconds on the instrument
and then select "Yes" to return
to the welcome message.
Sampling cannot
continue. The volume collected
flashes on the instrument.
Screen is frozen
on "MENU 6"
REMOVE
PROTECTION
COVER
The battery
autonomy test
started from MENU
6 has been
interrupted using
the <STOP> key.
Sampling has been
interrupted as the
protective cover
has been detected.
To continue the battery
autonomy test, press
<START>.
Replace the protective cover
with the grid and then press
<MENU> to return to the
welcome message.
If the message appears when
the protective cover has been
removed, please contact your
supplier.
Not applicable as the battery
autonomy test can only be
performed in MANUAL mode.
Acknowledge the fault to allow
another sampling cycle to
start. Close the sampling
cycle using the RUID.
Replace the protective cover
with the sampling grid in order
to start sampling.
If the message appears when
the protective cover has been
removed, contact your
Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual 6-1
Troubleshooting
Routine servicing
Indicator light
status
Green / Red
flashing
Error message Possible cause
MOTOR JAMMED
CALIBRATION
DATE EXPIRED
Welcome
message with
battery symbol
crossed out and
sound signal
(2 long beeps).
Sampling has been
interrupted as the
motor has jammed.
The calibration date
has expired.
Can only be
detected by the
RUID in slave
mode.
Battery is low. Charge the instrument battery.
Action
in MANUAL mode
Inspect the black grid under
the Petri dish retaining claws.
Press <MENU> to return to
the welcome message.
Not applicable as the instrument
cannot detect when the
calibration date has expired.
Sampling can be performed.
Sampling is allowed, unless
the remaining battery life is
shorter than the battery life
required to perform the
requested sampling cycle.
Action
in SLAVE mode
Inspect the black grid under
the Petri dish retaining claws.
Acknowledge the fault using
the RUID.
Use the RUID to acknowledge
the fault and allow another
sampling cycle to start.
Even if the calibration
date is not updated, the
instrument returns to the
welcome message and is able
to perform the programmed
sampling cycle.
However, the calibration date
expiry is recorded in the
sampling data.
Charge the instrument battery.
Sampling is allowed, unless
the remaining battery life is
shorter than the battery life
required to perform the
requested sampling cycle.
Constant red
Off
SERIAL NUMBER
UNKNOWN
NO
CALIBRATION
DATA
Screen off Sampling has been
Screen off Battery is low. Charge the battery. Charge the battery.
The serial number
is undefined.
No calibration data
stored in the
instrument memory.
interrupted as the
instrument was
disconnected from
the mains power
Contact your supplier. Contact your supplier.
Contact your supplier. Contact your supplier.
Reconnect the instrument to
the mains and press
<ON/OFF> to turn it on.
Sampling cannot continue.
Reconnect the instrument to
the mains and press
<ON/OFF> to switch it on.
Acknowledge the fault on the
RUID to allow another
sampling cycle to start and
then close the sampling cycle
using the RUID.
Sampling cannot
continue.
6-2 Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual
7 Appendix
Using the reading table
The following reading tables indicate the most probable number of micro-organisms
collected per plate (MPN collected) with respect to the number of agglomerates of colonies
counted on the agar (CFU read).
The MPN value is calculated from the CFU count, using FELLER’s law. This statistical
correction corresponds to the random passing of bacteria through the orifices of the grid.
It quantifies for each “visited” orifice, (i.e. for each cluster counted) and as a function of the
total number of clusters counted, the most probable number of bacteria which make up the
cluster concerned, i.e. the number of bacteria having passed through the same orifice.
The application of the statistical correction assumes that the CFU count on the agar
concerns the number of colony clusters, i.e. the number of orifices with a positive impact,
without distinguishing, within a given cluster, the number of confluent colonies of which it is
made up.
In order to determine the most probable number of micro-organisms collected per
cubic meter, the most probable number of micro-organisms collected per plate (MPN
collected) must be multiplied by 1000 and divided by the volume sampled in liters.
Example: Volume of air sampled = 50 liters
CFU count: 120
MPN value: 159, 380905
Result expressed as the MPN collected per cubic meter = 159 x 1000 / 50 = 3180
Information on FELLER’s law
The formula for FELLER’s law is the following:
MPN = N . (1/N + 1/N-1 + 1/N-2 + ………. + 1/N-CFU+1)
where:
MPN = most probable number of bacteria having passed through the orifices of the grid
N = number of orifices on the grid.
CFU = colony forming units, value obtained by the laboratory.
In the case of a sampling grid for which the passage of a particle through a given orifice of
the grid is purely random, there is a probability that, during a sampling cycle, several
particles pass through the same orifice and are therefore counted as a single and unique
CFU, while other orifices are not passed through by any particles.
The closer the CFU count obtained by the laboratory is to N, (total number of orifices on the
grid), the higher the probability is.
Moreover, the notion of probability density arises:
Example: for a given CFU value:
− there is a probability p2 that the same orifice is passed through by 2 particles
− there is a probability p3 that the same orifice is passed through by 3 particles
− there is a probability pi that the same orifice is passed through by i particles etc…
Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual 7-1
Appendix
1 1 37
39,770782
73
85,202311
109
140,067796
2
2,003788
38
40,933063
74
86,582519
110
141,766514
3
3,011392
39
42,100464
75
87,969954
111
143,476191
4
4,022843
40
43,273030
76
89,364690
112
145,196971
5
5,038168
41
44,450808
77
90,766807
113
146,928997
6
6,057399
42
45,633844
78
92,176381
114
148,672418
7
7,080565
43
46,822184
79
93,593494
115
150,427385
8
8,107697
44
48,015878
80
95,018225
116
152,194051
9
9,138825
45
49,214973
81
96,450657
117
153,972575
10
10,173982
46
50,419519
82
97,890875
118
155,763115
11
11,213197
47
51,629564
83
99,338962
119
157,565836
12
12,256504
48
52,845161
84
100,795006
120
159,380905
13
13,303935
49
54,066359
85
102,259094
121
161,208491
14
14,355523
50
55,293211
86
103,731317
122
163,048769
15
15,411300
51
56,525769
87
105,211764
123
164,901916
16
16,471300
52
57,764087
88
106,700528
124
166,768113
17
17,535557
53
59,008218
89
108,197703
125
168,647546
18
18,604105
54
60,258218
90
109,703385
126
170,540403
19
19,676979
55
61,514142
91
111,217670
127
172,446878
20
20,754215
56
62,776047
92
112,740659
128
174,367167
21
21,835848
57
64,043990
93
114,272451
129
176,301474
22
22,921913
58
65,318028
94
115,813148
130
178,250003
23
24,012448
59
66,598221
95
117,362856
131
180,212966
24
25,107490
60
67,884629
96
118,921679
132
182,190578
25
26,207075
61
69,177312
97
120,489727
133
184,183059
26
27,311241
62
70,476332
98
122,067108
134
186,190635
27
28,420028
63
71,781750
99
123,653934
135
188,213536
28
29,533473
64
73,093631
100
125,250320
136
190,251998
29
30,651617
65
74,412039
101
126,856380
137
192,306261
30
31,774498
66
75,737039
102
128,472234
138
194,376574
31
32,902158
67
77,068698
103
130,098001
139
196,463188
32
34,034636
68
78,407081
104
131,733803
140
198,566362
33
35,171976
69
79,752259
105
133,379766
141
200,686362
34
36,314217
70
81,104300
106
135,036016
142
202,823459
35
37,461403
71
82,463274
107
136,702683
143
204,977931
36
38,613577
72
83,829254
108
138,379898
144
207,150062
Reading tables
IMPORTANT! In practice, and whenever possible, to minimize statistical correction, it is
Reading tables
The probability pi decreases as i increases.
It is therefore particularly relevant to apply the statistical correction using FELLER’s law
when high CFU values are read, i.e. close to N, i.e. in the case of agar plates almost
completely saturated with colonies.
recommended to adjust the sample volume so that the CFU count does not exceed
100.
CFU
count
corrected
MPN
CFU
count
corrected
MPN
CFU
count
corrected
MPN
CFU
count
corrected
MPN
7-2 Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual
Appendix
145
209,340144
176
288,153475
207
400,832773
238
600,854201
146
211,548478
177
291,131003
208
405,401739
239
610,669016
147
213,775369
178
294,142367
209
410,050862
240
620,861324
148
216,021131
179
297,188344
210
414,783004
241
631,461324
149
218,286089
180
300,269739
211
419,601186
242
642,502990
150
220,570571
181
303,387386
212
424,508594
243
654,024729
151
222,874919
182
306,542148
213
429,508594
244
666,070184
152
225,199481
183
309,734919
214
434,604748
245
678,689231
153
227,544613
184
312,966627
215
439,800826
246
691,939231
154
229,910685
185
316,238232
216
445,100826
247
705,886600
155
232,298072
186
319,550732
217
450,508989
248
720,608822
156
234,707163
187
322,905162
218
456,029823
249
736,197057
157
237,138356
188
326,302598
219
461,668120
250
752,759557
158
239,592059
189
329,744156
220
467,428990
251
770,426224
159
242,068695
190
333,230999
221
473,317879
252
789,354796
160
244,568695
191
336,764332
222
479,340606
253
809,739411
161
247,092504
192
340,345413
223
485,503397
254
831,822744
162
249,640581
193
343,975550
224
491,812921
255
855,913653
163
252,213397
194
347,656105
225
498,276335
256
882,413653
164
254,811436
195
351,388500
226
504,901335
257
911,858098
165
257,435198
196
355,174214
227
511,696207
258
944,983098
166
260,085198
197
359,014794
228
518,669891
259
982,840241
167
262,761966
198
362,911853
229
525,832053
260
1027,006907
168
265,466048
199
366,867077
230
533,193165
261
1080,006907
169
268,198007
200
370,882228
231
540,764593
262
1146,256907
170
270,958423
201
374,959151
232
548,558711
263
1234,590241
171
273,747897
202
379,099776
233
556,589014
264
1367,090241
172
276,567046
203
383,306125
234
564,870264
265
1632,090241
173
279,416508
204
387,580319
235
573,418651
174
282,296943
205
391,924581
236
582,251984
175
285,209031
206
396,341248
237
591,389915
Reading tables
CFU
count
corrected
MPN
CFU
count
corrected
MPN
CFU
count
corrected
MPN
CFU
count
corrected
MPN
Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual 7-3
Loading...