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USER MANUAL (FCC STATEMENT IC STATEMENT) This is a copy of the page where the FCC statement is included:
User_Manual_-_161150-190_-_I_-_en_-_96307_-_air_IDEAL_3P_Traceability User_Manual_-_161150-190_-_I_-_fr_-_96307_-_air_IDEAL_3P_Traceability FCC ID: Y4A-AI3PTRA1 IC: 9411A-AI3PTRA1 Page 1/2 FCC ID: Y4A-AI3PTRA1 IC: 9411A-AI3PTRA1 Page 2/2
1 2 | User Manual | Users Manual | 2.30 MiB |
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Air IDEAL3PTM Traceability Solution AeroBioCollector User's Manual LCB 71260 La Salle France bioMrieux SA Chemin de l'Orme 69280 Marcy-l'toile - 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 Version A B C D E F G H I BRevisions The list of revisions below summarizes replacements or additional pages in your Users Manual Modifications Pages modified Date of printing 2001/01 Bilingual
(FR / EN) 2001/04 Multilingual
(FR / EN / ES / IT / DE / PT) 2005/11 Update of the manual
(FR / EN / ES) 2006/03 Update of the manual
(FR / EN / ES / IT / DE / PT) 2008/03 Environmental conditions
(FR / EN / ES / IT / DE / PT) All All All All 2-12 2010/10 Addition of a remote user interface device (RUID) to ensure sampling traceability. All 2011/04 Regulatory modifications:
FCC (USA) and IC (Canada). Pages 2-7, 2-8, 2-11, 2-13 Pages 3-2 and 5-1 2011/11 Airflow control 2013/09 Modification of spelling:
- airIDEAL 3PTM Traceability becomes
- Air IDEAL3PTM 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". 5-1 All Warning 3-1 3-2 3-2 3-4 3-6 5-1 5-2 Air IDEAL3P Traceability Solution AeroBioCollector User's Manual Revisions-1 7 W a r n i n g 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 bioMrieux SA products, software or services which are not available in the country of release; this shall not mean that bioMrieux SA intends to market such products, software or services in such country To request copies of publications or for any technical request, contact bioMrieux SA or your local distributor. IMPORTANT! Use of the instrument and manual implies acceptance of the clauses below and the 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. T r a d e m a r k s BIOMERIEUX, the blue logo, 3P, Air IDEAL and Count-Tact are used, pending and/or registered trademarks belonging to bioMrieux, 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 bioMrieux SA Photos: bioMrieux / Printed in France / bioMrieux 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 IDEAL3P 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 IDEAL3P 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 IDEAL3P Traceability ..........................................................................................................3-3 Rear face of the Air IDEAL3P 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 IDEAL3P 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 IDEAL3P Traceability Solution AeroBioCollector User's Manual I-1 Table of contents Air IDEAL3P Traceability menus ...................................................................................................................... 3-16 Turning on Air IDEAL3P Traceability ................................................................................................................ 3-17 Standby .................................................................................................................................................................. 3-18 Turning off Air IDEAL3P 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 IDEAL3P 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 FELLERs law ...................................................................................................................................... 7-1 Reading tables ............................................................................................................................................................. 7-2 I-2 Air IDEAL3P 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 IDEAL3P Traceability Figure 3-1: Air IDEAL3P 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 IDEAL3P Traceability Solution AeroBioCollector User's Manual II-1 1 How to use this manual IMPORTANT! Please read the "General safety and regulatory information" booklet provided with the instrument. F i n d i n g t o p i c s a n d p r o c e d u r e s Table of contents List of figures Warnings Page headers and page footers table of contents of This manual is divided into 7 chapters. The It lists each chapter and the procedures within each chapter. The list of figures for the manual is located on page II-1. the manual is located on pages I-1 to I-2. 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!). Different types of warnings are used throughout the manual:
Apart from the first page of every chapter, each page of the manual includes a page header and a footer. Each page header includes the chapter title and the title of a procedure or its corresponding description. The footers contain the title of the manual, the name of the product and the page number. Air IDEAL3P Traceability Solution AeroBioCollector User's Manual 1-1 How to use this manual Glossary G l o s s a r y ABS Acrylonitrile butadiene styrene. AeroBioCollector or Air sampler Air IDEAL3P Traceability, instrument used to collect and count viable bacterial and fungal particles in a known and precise volume of air. CFU 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 Time between pressing the START button and the motor starting up. Li-ion MPN PVDF Ra coefficient RUID Sampling grid Solution Air IDEAL3P Traceability Lithium ion Most Probable Number of micro-organisms collected. Statistical correction of the CFU value (FELLERs law). Polyvinylidene fluoride. Roughness factor of a surface. It is the arithmetic mean of all profile deviations, positive or negative, compared to the mean line.
"Remote User Interface Device"
Remote control containing the user interface. Perforated and calibrated plastic device. The number of orifices, their diameter and arrangement, guarantee a CFU count (positive clusters) and a flow of air corresponding to the motor setting. IDEAL3P Traceability Air Air IDEAL3P Traceability software.
(AeroBioCollector) + RUID
(remote control) +
Time-delay Two seconds required by the software to record a parameter. 1-2 Air IDEAL3P Traceability Solution AeroBioCollector User's Manual How to use this manual Typographic conventions T y p o g r a p h i c c o n v e n t i o n s These conventions are used in the different chapters of the manual. 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. A i r I D E AL 3 P T r a c e a b i l i t y k e y p a d 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 IDEAL3P Traceability Solution AeroBioCollector User's Manual 1-3 2 Functional description P r e s e n t a t i o n
"Pharmaceutical manufacturing evolves from an art to a science". This sentence alone from the FDA Guideline Pharmaceutical cGMPs for the 21st century A Risk-Based Approach summarizes the current revolution in the Pharmaceutical industry. Conscious of these changes and remaining attentive to its customers, bioMrieux decided to improve its Air IDEAL3P Traceability AeroBioCollector in order to best respond to these 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 micro-
organisms in less demanding work environments such as agribusiness. In its Air IDEAL3P Traceability is still available in two versions:
one for the use of culture media in 90 mm diameter Petri dishes, The aspiration flow-rate of Air IDEAL3P Traceability is calibrated at 100 l/min with an 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. the other designed for use with 65 or 70 mm plates. universal continue addition order and to in application, Principle of use Air IDEAL3P Traceability can operate in 2 modes:
Slave mode: using Air IDEAL3P Traceability with the RUID. Manual mode: autonomous operation using the keypad. 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 IDEAL3P Traceability Solution AeroBioCollector User's Manual 2-1 Functional description Presentation Operating principle Performance Air IDEAL3P 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 m3 of air. Air inlet Calibrated orifice Micro-organisms Impaction Nutrient medium Air jets 90 or 65/70 mm diameter Petri dishes Air outlet Figure 2-1: Principle of the impaction biocollector 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 IDEAL3P 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, bioMrieux commissioned two recognized independent organizations to validate the physical and biological efficiency of the instrument. CETIAT: Centre Technique des Industries Arauliques et Thermiques/Technical Center of Aeraulic and Thermal Industries Domaine Scientifique de la Doua, 69603 Villeurbanne, France HPA : Health Protection Agency - Porton Down - Wiltshire SP4 0JG Salisbury - UK 2-2 Air IDEAL3P Traceability Solution AeroBioCollector User's Manual Collection efficiency validated according to the ISO 14698 standard Air IDEAL3P 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. Functional description Presentation 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 IDEAL3P Traceability was evaluated for recovery of a mixture 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. Use in glove boxes Applications to to be used test glove boxes, the design and materials of In order Air IDEAL3P 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). IDEAL3P Traceability enables precise and Air 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. reproducible air sampling. Air IDEAL3P Traceability Solution AeroBioCollector User's Manual 2-3 3 Using Air IDE AL 3P Traceability D e s c r i p t i o n Air IDEAL3P 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 (product no. 410174) For each product number, please refer to the packing list provided with the instrument. Figure 3-1: Air IDEAL3P Traceability in its carrying case 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
(product No. 96301). Sterile box for transport and
(product No. 96311*). incubation of 90 mm plates Kit of 10
* Availability: consult bioMrieux Air IDEAL3P Traceability Solution AeroBioCollector User's Manual 3-1 Using Air IDEAL3P Traceability Description Consumables Air IDEAL3P 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 bioMrieux, 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 Irradiated media 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 agar 20 x 65 mm plates (product no. 43501) 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) 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 IDEAL3P Traceability Solution AeroBioCollector User's Manual Front face of the Air IDEAL 3P Traceability Using Air IDEAL3P Traceability Description Rear face of the Air IDEAL 3P Traceability Figure 3-3: Front face Handle Air outlet Threading for tripod Jack socket Figure 3-4: Rear face Air IDEAL3P Traceability Solution AeroBioCollector User's Manual 3-3 Using Air IDEAL3P Traceability Sampling grid Keypad Figure 3-5: Keypad S a m p l i n g g r i d Configuration for 65, 70 or 90 mm Petri dishes 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 Figure 3-6: Diameter of Petri dishes 3-4 Air IDEAL3P Traceability Solution AeroBioCollector User's Manual Stainless steel strip for attachment Seal Using Air IDEAL3P Traceability Sampling grid Aspiration orifice Figure 3-7: Sampling head 65, 70 or 90 mm Petri dishes Tripod assembly Figure 3-8: Tripod assembly Air IDEAL3P Traceability Solution AeroBioCollector User's Manual 3-5 Using Air IDEAL3P Traceability General specifications G e n e r a l s p e c i f i c a t i o n s Environmental conditions Normal storage conditions ................................................................................ -20 to + 50C 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 Mass Materials Height Width Depth Instrument alone 128 mm (5.03 in.) 146 mm (5.75 in.) 208 mm (8.18 in.) Instrument in its case 301 mm (11.8 in.) 250 mm (9.84 in.) 400 mm (15.75 in.) Instrument alone 1.2 kg Instrument in its case 5.5 kg Shipping carton 7.1 kg ABS/Polycarbonate shell Polycarbonate keypad PVDF sampling grid Stainless steel mounting strips and screws Elastomer jack protection caps 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 IDEAL3P Traceability Solution AeroBioCollector User's Manual Using Air IDEAL3P Traceability General specifications Technical characteristics Keypad Key control. Display Sampling grid User interface Ergonomics Liquid crystal display (2 x 16 characters). 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). Air IDEAL3P Traceability can operate in 2 modes:
Slave mode: using Air IDEAL3P Traceability with the RUID. Manual mode: autonomous operation using the keypad. 5 buttons for access to all Air IDEAL3P Traceability functions. 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. Language used for the software: English Ergonomic handle (right hand/left hand). Possibility of stable sampling with the unit in four positions (see page 3-11). Possibility of suspending Air IDEAL3P 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 IDEAL3P Traceability Solution AeroBioCollector User's Manual 3-7 Using Air IDEAL3P Traceability General specifications Electrical characteristics Voltage........................................................................................................... 7.4 VDC nominal Power supply .............................................................................................................. 1 A max. Air IDEAL3P 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. 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. It is recommended to use the adapter provided with the instrument. You will find the details of its characteristics below. CAUTION!
Note:
POWER SUPPLY complying with 100 240 VAC INPUT UL STD plug or STD European plug 12 VDC OUTPUT d = 2.1 mm JACK plug
- UL/CSA standards 0.7 A 0.4 A 47 63 Hz 2 A max. Functional specifications Flow-rate 100 6.4 liters per minute regardless of the grid used. Flow-rate measured and adjusted according to the bioMrieux quality control protocol reference 96302-protocol. Autonomy Charge time Sound level Security 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. It takes 3 hours to fully charge the battery.
< 50 dB Male plug outlet serves as the power supply sectioning device. 3-8 Air IDEAL3P Traceability Solution AeroBioCollector User's Manual U n p a c k i n g Ai r I D E AL 3 P T r a c e a b i l i t y Using Air IDEAL3P Traceability Unpacking Air IDEAL3P 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 bioMrieux. 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. R e c o m m e n d a t i o n s f o r i n s t a l l a t i o n a n d u s e 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 IDEAL3P Traceability Solution AeroBioCollector User's Manual 3-9 Using Air IDEAL3P Traceability Recommendations for installation and use WARNING! The users 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 users 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 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 to an outlet on a different circuit to the one to which the interference receiver is connected. WARNING!
is not more Consult the dealer or an experienced radio/TV technician for help. Industry 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.) for successful communication. RSS-Gen - General Requirements and Information for the Certification of Radio Apparatus, Clause 7.1.3 statement:
This device complies with 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. Industry Canada that necessary than 3-10 Air IDEAL3P Traceability Solution AeroBioCollector User's Manual S a m p l i n g p o s i t i o n s Using Air IDEAL3P Traceability Sampling positions Figure 3-9: Sampling positions IMPORTANT! Air IDEAL3P Traceability is delivered with a hook for suspending it in a glove box 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. Air IDEAL3P Traceability Solution AeroBioCollector User's Manual 3-11 Using Air IDEAL3P Traceability Screwing on the sampling grid S c r e w i n g o n t h e s a m p l i n g g r i d 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. Figure 3-10: Screwing on the sampling grid E l e c t r i c a l p o w e r s u p p l y Air IDEAL3P 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 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.
, there are 20 minutes of autonomous running 3-12 Air IDEAL3P Traceability Solution AeroBioCollector User's Manual Low battery signals Using Air IDEAL3P Traceability Electrical power supply When the battery life has expired, the following low battery signals are output:
Visual signal on the welcome message display:
Visual signal on the sample in progress display:
Flashing symbol Flashing symbol IMPORTANT!
Audible signal when the instrument is turned on: 2 long beeps emitted each time the instrument is powered on. In slave mode, if the battery is low at the beginning of an analysis, the operator is warned by a message displayed on the RUID (please refer to the remote control user manual). Charging 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 IDEAL3P 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 IDEAL3P 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 IDEAL3P Traceability Solution AeroBioCollector User's Manual 3-13 Using Air IDEAL3P 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. Check that the battery life displayed is again 4 hours. Install the protection cap. IMPORTANT!
If Air IDEAL3P 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 the <START> button. To turn off, Disconnect the charger from the Jack socket on the instrument. IMPORTANT! During sampling with Air IDEAL3P 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. Automatic standby Automatic switch off 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 IDEAL3P Traceability cannot communicate with a RUID. 3-14 Air IDEAL3P Traceability Solution AeroBioCollector User's Manual Using Air IDEAL3P Traceability Operation in slave mode O p e r a t i o n i n s l a v e m o d e In slave mode, the Air IDEAL3P Traceability is used with a RUID. Please refer to the RUID User Manual. O p e r a t i o n i n m a n u a l m o d e In manual mode the Air IDEAL3P Traceability operates autonomously. Programming Air IDEAL3P 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. 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 IDEAL3P Traceability Solution AeroBioCollector User's Manual 3-15 Using Air IDEAL3P Traceability Operation in manual mode Air IDEAL 3P Traceability menus Turning on. WELCOME MESSAGE MENU 1:
MENU 2:
MENU 3:
MENU 4:
MENU 5:
Last sample taken. Remaining autonomy. Selection of one of 4 sample volumes among the 4 volumes pre-
programmed in menu 3. Programming 1 sample volume not in memory. Modification of the 4 pre-programmed sample volumes. Programming delayed start-up. Programming sequenced sampling. MENU 6:
Battery autonomy test. Turning off. 3-16 Air IDEAL3P Traceability Solution AeroBioCollector User's Manual Turning on Air IDEAL 3P Traceability Using Air IDEAL3P Traceability Operation in manual mode To turn on the instrument, Press <ON/OFF>. The display indicates:
Note:
The symbol is displayed if a delayed start-up is programmed. ZZZL corresponds to the last sample volume recorded. XHXX corresponds to remaining battery life. If the symbol appears:
Recharge the instrument. 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 IDEAL3P Traceability Solution AeroBioCollector User's Manual 3-17 Using Air IDEAL3P 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 IDEAL3P Traceability:
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. 3-18 Air IDEAL3P Traceability Solution AeroBioCollector User's Manual Using Air IDEAL3P Traceability Operation in manual mode Example:
To select stored volume No. 2 from menu 1, Press < + > twice. Note:
Wait 2 seconds. 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 IDEAL3P Traceability Solution AeroBioCollector User's Manual 3-19 Using Air IDEAL3P 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 < + > or < - > buttons immediately to program a new volume. 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 IDEAL3P Traceability Solution AeroBioCollector User's Manual Using Air IDEAL3P 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 < + > or < - > buttons immediately to program a new 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. To program a new volume for program 2, Press < + > or < - > until the desired volume is displayed. IMPORTANT!
It is imperative to press the < + > or < - > buttons immediately to program a new volume. After a 2-second delay, the volume displayed is recorded. The display indicates:
To program a new volume for program 3, Press < + > or < - > until the desired volume is displayed. IMPORTANT!
It is imperative to press the < + > or < - > buttons immediately to program a new volume. After a 2-second delay, the volume displayed is recorded. The display indicates:
Air IDEAL3P Traceability Solution AeroBioCollector User's Manual 3-21 Using Air IDEAL3P 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 < + > or < - > buttons immediately to program a new 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. Possibility of going directly to "MENU 4", once selected volumes are modified:
When "END" is displayed on the screen, Menu 4 is displayed. Immediately press <MENU>. 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 IDEAL3P Traceability Solution AeroBioCollector User's Manual Using Air IDEAL3P 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 < + > or < - > to program a new volume. After 2-seconds, the delay value is recorded. The display indicates:
The screen returns to the welcome message. The delay is recorded: the symbol appears in the welcome message. 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. 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 IDEAL3P Traceability Solution AeroBioCollector User's Manual 3-23 Using Air IDEAL3P 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. The "INTXHXX" (INTERVAL) field flashes. 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 IDEAL3P Traceability Solution AeroBioCollector User's Manual Battery autonomy test (Menu 6) Using Air IDEAL3P Traceability Operation in manual mode 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:
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 IDEAL3P Traceability turns off. To turn it back on, press
. Air IDEAL3P Traceability Solution AeroBioCollector User's Manual 3-25 Using Air IDEAL3P Traceability Starting sampling S t a r t i n g s a m p l i n g CAUTION!
Before starting, check that Air IDEAL3P Traceability is fitted with a sampling grid and not its protective cover otherwise it could undergo irreversible damage which is not covered by the bioMrieux 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. Press <MENU> to return to the welcome message. Install the grid. 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 IDEAL3P Traceability Solution AeroBioCollector User's Manual 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. Using Air IDEAL3P Traceability Starting sampling 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. The motor stops 2 liters before the total volume has been sampled. Note:
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 IDEAL3P Traceability Solution AeroBioCollector User's Manual 3-27 Using Air IDEAL3P 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 IDEAL3P Traceability Solution AeroBioCollector User's Manual Using Air IDEAL3P Traceability Setting Air IDEAL3P Traceability parameters (summary diagram) S e t t i n g Ai r I D E A L 3 P T r a c e a b i l i t y p a r a m e t e r s ( s u m m a r y d i a g r a m ) 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") 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. 4 x Air IDEAL3P Traceability Solution AeroBioCollector User's Manual 3-29 Using Air IDEAL3P Traceability Setting Air IDEAL3P Traceability parameters (summary diagram) 4 x Menu 4 : Programming delayed start-up. Select delay before starting Press < + > or < - > until the delay value is displayed. 5 x Menu 5 : Programming sequenced samplings. Press < + > or < - > until the desired number is displayed. 6 x Menu 6 : Battery autonomy test. Select number of sequences 1 x Press < + > or < - > until the desired time is displayed. Select time between sequences 3-30 Air IDEAL3P Traceability Solution AeroBioCollector User's Manual M a i n t e n a n c e M e n u Using Air IDEAL3P Traceability Maintenance Menu NEXT CALIBRATION MM/DD/YYYY XXXX Serial number STORED VOL: ZZZL BATTERYLIFE :XHXX Navigation using < + > and< - > keys XXXXYXXXXYXX MAC ADRESS FREE MEMORY XXXX WORDS FSE (Field Service Engineer) XXXXXX RUID Serial XXXXXXXXX FRMB Serial XX Soft Version X.X LAST CALIBRATION MM/DD/YYYY IMPORTANT!
This information can be viewed by the user, but it can only be updated by bioMrieux Technical Assistance or the local bioMrieux representative. Air IDEAL3P Traceability Solution AeroBioCollector User's Manual 3-31 Using Air IDEAL3P 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 IDEAL3P Traceability firmware version Air IDEAL3P Traceability available memory size MAC address (Media Access Control) Air IDEAL3P Traceability serial number Air IDEAL3P Traceability Solution AeroBioCollector User's Manual 3-32 4 Procedure P r i n c i p l e 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. P r o c e d u r e 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 IDEAL3P Traceability Solution AeroBioCollector User's Manual 4-1 Procedure How to obtain a good quality sample H o w t o o b t a i n a g o o d q u a l i t y s a m p l e 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 IDEAL3P Traceability Solution AeroBioCollector User's Manual S a m p l i n g p l a n Procedure 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.). R e c o r d i n g a n d e v a l u a t i n g r e s u l t s If unacceptable results are obtained, corrective action may be necessary. The person in charge of controlling the quality of air collects the results recorded. Results which give expected values are validated. The document for recording results must include:
date and time of sample, operators name, critical point controlled, the situation of the control in relation to the activity (production cycle, pre or post-
operative, etc.), level of internal activity (number of people present, number of lines running, etc.), thermohygrometric conditions (real or reference), detailed stages of the procedure, micro-organism to be isolated, culture medium used, date and time of incubation, date and time of reading, decision: validation/ corrective action. reference level and alert level, result: acceptable/unacceptable, incubation conditions (duration, temperature), Air IDEAL3P Traceability Solution AeroBioCollector User's Manual 4-3 5 Maintenance P r e v e n t i v e m a i n t e n a n c e CAUTION!
No preventive maintenance needs to be performed by the user. If an anomaly occurs on your instrument, call bioMrieux 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 bioMrieux or your local distributor. R o u t i n e s e r v i c i n g 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 IDEAL3P Traceability is delivered with a set of 5 grids. They can be sterilized by autoclaving at 134C for 18 min. bioMrieux has validated that the grid specifications and performance are not altered after autoclaving up to:
40 times at 134C for 18 minutes 200 times at 121C 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 IDEAL3P 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 bioMrieux. 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 IDEAL3P 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:
boxes. The capacity of the instrument to withstand standard decontamination cycles in glove 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 The airflow control must be performed once a year from the date of the last control or adjustment. IMPORTANT!
The airflow control must be performed by bioMrieux Technical Assistance or the local bioMrieux representative. 5-2 Air IDEAL3P Traceability Solution AeroBioCollector User's Manual 6 Troubleshooting Indicator light status Flashing red Error message Possible cause Action in MANUAL mode Action in SLAVE mode LAST SAMPLING NOT COMPLETED Sampling is interrupted in MANUAL mode. Press <MENU> to return to the welcome message. Press <MENU> to return to the welcome message. LAST SAMPLING NOT COMPLETED Sampling is interrupted in SLAVE mode. N/A ERROR BATTERYLIFE There is insufficient battery life to perform the sampling program. Connect the instrument to the mains power so that sampling can start or put the battery on charge. ERROR TIME >
5H Flashing volume is displayed The total duration of sequenced samplings programmed in MENU 5 has exceeded 5 hours. Sampling has been accidentally interrupted by the operator. 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>. Acknowledge the fault on the 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. Not applicable as the battery autonomy test can only be performed in MANUAL mode. To continue the battery autonomy test, press
<START>. 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. 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. 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 supplier. Air IDEAL3P Traceability Solution AeroBioCollector User's Manual 6-1 Troubleshooting Routine servicing Indicator light status Error message Possible cause Action in MANUAL mode Action in SLAVE mode MOTOR JAMMED Sampling has been interrupted as the motor has jammed. Inspect the black grid under the Petri dish retaining claws. Press <MENU> to return to the welcome message. Inspect the black grid under the Petri dish retaining claws. Acknowledge the fault using the RUID. CALIBRATION DATE EXPIRED The calibration date has expired. Can only be detected by the RUID in slave mode. Not applicable as the instrument cannot detect when the calibration date has expired. Sampling can be performed. 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. Green / Red flashing Welcome message with battery symbol crossed out and sound signal
(2 long beeps). Battery is low. 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. 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. SERIAL NUMBER UNKNOWN The serial number is undefined. Contact your supplier. Contact your supplier. NO CALIBRATION DATA Screen off No calibration data stored in the instrument memory. Sampling has been interrupted as the instrument was disconnected from the mains power 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. Screen off Battery is low. Charge the battery. Charge the battery. Constant red Off 6-2 Air IDEAL3P Traceability Solution AeroBioCollector User's Manual 7 Appendix U s i n g t h e r e a d i n g t a b l e 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 FELLERs 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 I n f o r m a t i o n o n F E L L E R s l a w The formula for FELLERs 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 IDEAL3P Traceability Solution AeroBioCollector User's Manual 7-1 Appendix Reading tables The probability pi decreases as i increases. It is therefore particularly relevant to apply the statistical correction using FELLERs 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. IMPORTANT!
In practice, and whenever possible, to minimize statistical correction, is recommended to adjust the sample volume so that the CFU count does not exceed 100. it R e a d i n g t a b l e s CFU count corrected MPN CFU count corrected MPN CFU count corrected MPN CFU count corrected MPN 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 1 2,003788 3,011392 4,022843 5,038168 6,057399 7,080565 8,107697 9,138825 10,173982 11,213197 12,256504 13,303935 14,355523 15,411300 16,471300 17,535557 18,604105 19,676979 20,754215 21,835848 22,921913 24,012448 25,107490 26,207075 27,311241 28,420028 29,533473 30,651617 31,774498 32,902158 34,034636 35,171976 36,314217 37,461403 38,613577 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 39,770782 40,933063 42,100464 43,273030 44,450808 45,633844 46,822184 48,015878 49,214973 50,419519 51,629564 52,845161 54,066359 55,293211 56,525769 57,764087 59,008218 60,258218 61,514142 62,776047 64,043990 65,318028 66,598221 67,884629 69,177312 70,476332 71,781750 73,093631 74,412039 75,737039 77,068698 78,407081 79,752259 81,104300 82,463274 83,829254 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 85,202311 86,582519 87,969954 89,364690 90,766807 92,176381 93,593494 95,018225 96,450657 97,890875 99,338962 100,795006 102,259094 103,731317 105,211764 106,700528 108,197703 109,703385 111,217670 112,740659 114,272451 115,813148 117,362856 118,921679 120,489727 122,067108 123,653934 125,250320 126,856380 128,472234 130,098001 131,733803 133,379766 135,036016 136,702683 138,379898 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 140,067796 141,766514 143,476191 145,196971 146,928997 148,672418 150,427385 152,194051 153,972575 155,763115 157,565836 159,380905 161,208491 163,048769 164,901916 166,768113 168,647546 170,540403 172,446878 174,367167 176,301474 178,250003 180,212966 182,190578 184,183059 186,190635 188,213536 190,251998 192,306261 194,376574 196,463188 198,566362 200,686362 202,823459 204,977931 207,150062 Air IDEAL3P Traceability Solution AeroBioCollector User's Manual 7-2 Appendix Reading tables CFU count corrected MPN CFU count corrected MPN CFU count corrected MPN CFU count corrected MPN 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 209,340144 211,548478 213,775369 216,021131 218,286089 220,570571 222,874919 225,199481 227,544613 229,910685 232,298072 234,707163 237,138356 239,592059 242,068695 244,568695 247,092504 249,640581 252,213397 254,811436 257,435198 260,085198 262,761966 265,466048 268,198007 270,958423 273,747897 276,567046 279,416508 282,296943 285,209031 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 288,153475 291,131003 294,142367 297,188344 300,269739 303,387386 306,542148 309,734919 312,966627 316,238232 319,550732 322,905162 326,302598 329,744156 333,230999 336,764332 340,345413 343,975550 347,656105 351,388500 355,174214 359,014794 362,911853 366,867077 370,882228 374,959151 379,099776 383,306125 387,580319 391,924581 396,341248 207 208 209 210 211 212 213 214 215 216 217 218 219 220 221 222 223 224 225 226 227 228 229 230 231 232 233 234 235 236 237 400,832773 405,401739 410,050862 414,783004 419,601186 424,508594 429,508594 434,604748 439,800826 445,100826 450,508989 456,029823 461,668120 467,428990 473,317879 479,340606 485,503397 491,812921 498,276335 504,901335 511,696207 518,669891 525,832053 533,193165 540,764593 548,558711 556,589014 564,870264 573,418651 582,251984 591,389915 238 239 240 241 242 243 244 245 246 247 248 249 250 251 252 253 254 255 256 257 258 259 260 261 262 263 264 265 600,854201 610,669016 620,861324 631,461324 642,502990 654,024729 666,070184 678,689231 691,939231 705,886600 720,608822 736,197057 752,759557 770,426224 789,354796 809,739411 831,822744 855,913653 882,413653 911,858098 944,983098 982,840241 1027,006907 1080,006907 1146,256907 1234,590241 1367,090241 1632,090241 Air IDEAL3P Traceability Solution AeroBioCollector User's Manual 7-3
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2014-02-19 | JBP - Part 15 Class B Computing Device Peripheral | Original Equipment | |
2 | 2400 ~ 2483.5 | DSS - Part 15 Spread Spectrum Transmitter |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 2 | Effective |
2014-02-19
|
||||
1 2 | Applicant's complete, legal business name |
LCB
|
||||
1 2 | FCC Registration Number (FRN) |
0020401394
|
||||
1 2 | Physical Address |
Eaux Mortes
|
||||
1 2 |
LA SALLE, N/A 71260
|
|||||
1 2 |
France
|
|||||
app s | TCB Information | |||||
1 2 | TCB Application Email Address |
c******@curtis-straus.com
|
||||
1 2 | TCB Scope |
A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices
|
||||
1 2 |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
|||||
app s | FCC ID | |||||
1 2 | Grantee Code |
Y4A
|
||||
1 2 | Equipment Product Code |
AI3PTRA1
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 2 | Name |
E******** C********
|
||||
1 2 | Title |
Managing director
|
||||
1 2 | Telephone Number |
3 85 ******** Extension:
|
||||
1 2 | Fax Number |
3 85 ********
|
||||
1 2 |
e******@lcbfoodsafety.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 2 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 2 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 2 | Equipment Class | JBP - Part 15 Class B Computing Device Peripheral | ||||
1 2 | DSS - Part 15 Spread Spectrum Transmitter | |||||
1 2 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Digital Device | ||||
1 2 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 2 | Modular Equipment Type | Does not apply | ||||
1 2 | Purpose / Application is for | Original Equipment | ||||
1 2 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | Yes | ||||
1 2 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 2 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 2 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 2 | Firm Name |
LCIE Sud-Est
|
||||
1 2 | Name |
J**** L****
|
||||
1 2 | Telephone Number |
33-4-********
|
||||
1 2 | Fax Number |
33-4-********
|
||||
1 2 |
j******@Lcie.fr
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15B | CC | ||||||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
2 | 1 | 15C | CC | 2400.00000000 | 2483.50000000 | 0.0010000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC