Air Sampler 5j1a41

ENGLISH

“SAS SUPER ISO 100” “SAS SUPER ISO 180” Code n. 86279/86834 INSTRUCTIONS MANUAL

Carefully read this Manual before operating your instrument. This document is the property of International pbi Spa Milan It may not be duplicated or distributed without the owner’s authorisation Patent Pending Manufactured by International pbi Spa Milan, Italy REFERENCES FDA – 1987 Guideline on Sterile Drug Products produced by Aseptic Process ACGIH – Guideline for the Assessment of Bioaerosol in the Indoor Environment ASTM – Draft Protocol – Committee D22.05.06 USP 24-NF 19 par.1116– Microbiological Evaluation of Clean Rooms and other Controlled Environments EU Guide for GMP – Manufacture of Sterile Medicinal Products Control of Medicines and Inspection CEN/TC 243 Norms for Clean Room Technology ISO/DIS 14698-1 ISO EN-17025 Good Laboratori Practice Your local distributor:

International PBI S.p.A.

International pbi S.p.A.

Via Novara, 89 – 20153 Milano – Italy – Tel + 39 02 48779-1 – Fax + 39 02 40090010 E-mail: [email protected] – www.internationalpbi.it

« Sas Super Iso 100/180 »

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1

INSTRUCTION MANUAL

READ THIS BOOK CAREFULLY It is intended to help you operate and maintain your new instrument properly. Keep it handy for answers to your questions. IMPORTANT SAFETY INSTRUCTIONS When using this appliance, always exercise basic safety precautions, including the following: ƒ ƒ ƒ

Use this appliance only for its intended purpose as described in this Use and Care book. This instrument must be properly installed in accordance with the Installation Instructions before it is used. Repair or replace immediately all electric service cords that have become frayed or otherwise damaged. Do not use cord that shows cracks or abrasion damage along its length or at either the plug or connector end.

Turn off your instrument: A. Before making any repair. Note: We strongly recommend that any servicing be performed by a qualified individual. B. Before cleaning. C. Before replacing any accessories. • Do not operate your instrument in the presence of explosive fumes.

LEGGERE ATTENTAMENTE QUESTO MANUALE Lo scopo è quello di aiutarVi ad usare e conservare il Vostro nuovo strumento nelle migliori condizioni. Il Manuale deve essere tenuto sempre a portata di mano per ogni esigenza. INFORMAZIONI DI SICUREZZA ƒ Usare lo strumento solo per gli scopi indicati e come descritto nel Manuale. ƒ Lo strumento deve essere correttamente installato secondo quanto indicato nel manuale,prima di procedere al suo impiego. ƒ Riparare o sostituire immediatamente il cavo elettrico di allacciamento nel caso sia danneggiato; non usare mai un cavo che presenti incrinature,abrasioni sia nella sua lunghezza che in corrispondenza della spina o del connettore terminale. Spegnere il Vostro strumento ogniqualvolta: A. Si deve provvedere ad una riparazione le riparazioni dovrebbero sempre essere affidate solo a personale qualificato; B. Si deve provvedere alla pulizia; C. Si devono sostituire parti di ricambio od accessori; • Non utilizzare questo strumento in presenza di fumi esplosivi.

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MANUALE ISTRUZIONI

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SUMMARY TABLE OF CONTENTS SECTION ONE Brief Operating Instructions Visual Display Presentation

PAGE 5 5

SECTION TWO Operating Instructions 1. Principle 2. The basic idea 3. Installation 3.1 The Practical Use 3.2. List of MENU and SUB-MENU 3.3. Preliminary Inspection 3.4. 55 mm Plate holder adjusting 3.5. 84 mm Maxi Plate use (optional) 3.6. Petri: head adapter (optional) 3.7. 90 mm Petri Dishes filling 3.8. Tripod Installation (optional) 4. Software Function 4.1. Routine Sampling 4.2. Select Volume function 4.3. Utility Mode function 4.3.1. Set Time 4.3.2. Sampling Site 4.3.3. Operator Identification 4.3.4. Language 4.3.5. Display Record 4.3.6. Clear Record 4.3.7. Remote Control 4.3.8. Calibration 4.4. Program Volume function 4.5. Set Delay function 4.6. Multi Mode function 4.7. Configuration function 4.8. Power Off function 5. Operations 5.1. Plate holder adjustment 5.2. Plate handling 5.3. Sanitation of air sampler 5.4. Use in Clean Rooms 5.5. Plate Preparation 5.6. Total Bacterial Count and/or Micro-organisms identification by dilution 5.7. Multi Point Sampling with several indipendent air samplers 5.8. Multi-Point Sampling with several connected air samplers 5.9. Final Operations 6. Result Calculation and Recording 6.1. CFU/1000 Litres 6.2. Data Recording

6 6 6 7 7 8 9 10 10 10 10 10 11 11 12 13 13 14 15 16 16 17 17 17 18 19 20 22 25 26 26 26 27 27 28 28 28 29 29 29 29 31

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32 35 35 35 36 36 36

SECTION FOUR 8. Maintenance 8.1. Cleaning 8.2. Validation and Calibration 8.3. Performance Routine Monitoring 8.4. Trouble Shooting 8.5. Battery Replacement 8.6. Accessory and Spare Part List

37 37 37 38 38 38 38

SECTION FIVE EN 17025 Documentation

39

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SECTION THREE 7. Specifications 7.1. Sampling Time Requested For Different Air Volumes 7.2. Battery Charger Operation 7.3. Automatic Switch OFF 7.4. Sampling at High Altitude Over The Sea Level 7.5. Automatic Flux Control 7.6. Calibration Reminder

4

SECTION ONE BRIEF OPERATING INSTRUCTIONS FOR SAS SUPER ISO 100 AND 180

The air flow is visualized on digital display at the fourth automatic succession presentation each time the instrument is switched on. Touch the screen for at least two seconds to switch on the instrument. Press START to sample the same air volume as the last sampling cycle. To change the volume of air, touch MENU, to reach “select volume”, touch ENTER and use arrows to choose the desired new volume of air. Refer to instruction manual to change settings. Touch ENTER to confirm selection. Touch MENU and arrows for menu selection to modify other pre-set parameters: SELECT VOLUME POWER OFF UTILITY MODE CONFIGURATION MULTI MODE SET DELAY PROGRAM VOLUME Touch ENTER to reach the sub-menu of the chosen parameter. Refer to instruction manual to change settings. Touch STOP each time you need to end an action. Then the unit will come back to the initial configuration. Touch MENU, then arrows to reach POWER OFF, and ENTER to switch off the unit. ƒ

VISUAL DISPLAY PRESENTATION

(Touch the screen for at least two seconds). Each time the screen is touched, a five seconds visual display presentation will appear displaying the following information (this is just an example, the information provided may be different):

S-SAS

S-SAS 180 Rev. 5.1 – 5.00 S/N 05-01-1013

08/31/06

11.31

SITE AAAAAAAA 500 Lt. ID 12345678

DELAY 00 MIN

START

MENU

This information appears in automatic succession.

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ƒ

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OPERATING INSTRUCTIONS

1. PRINCIPLE OF SURFACE AIR SYSTEM The Surface Air System (SAS) encomes several models which use the same principle. Air is aspirated at a fixed speed for variable time through a cover which has been machined with a series of small holes of a special design. The resulting laminar air flow is directed onto the agar surface of a “ Plate” (or Petri dish) containing medium consistent with the microbiological examination to be performed. When the preset sampling cycle is completed, the plate is removed and incubated. The organisms are then visible to the naked eye and can be counted for an assessment of the level of contamination.

2. THE BASIC IDEA The major points of the Surface Air System (SAS) are: A. To use a simple and inexpensive “ Plate” (“SURFAIR PLATE”, “RODAC”) for surface, hands or air control. These plates are very well known and easily available. They can be purchased ready poured with different media. B. To sample a known volume of air for a variable time to provide a range of sampling volumes according to ISO………….. C. To aspirate air in a laminar flow pattern with sufficient velocity to impact organisms onto an agar surface. D. To accumulate data on the level of hygiene in each environment so that fluctuation can be monitored. E. To take advantage of advanced electronics for more reliable results in different operating conditions. F. To have the flexibility to choose between 55 mm Plates, 84 mm Maxi Plates, 90 mm Standard disposable Petri Dishes or glass reusable 100 mm Petri Dishes. G. To apply cGLP and cGMP to air sampling operations. H. To organize sequential sampling to obtain a more representative sample under actual operating conditions.

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SECTION TWO

SAS SUPER ISO 100 and SAS SUPER ISO 180: Two instruments for two different applications.

SAS SUPER ISO 100 = 100 litres of air per minute SAS SUPER ISO 180 = 180 litres of air per minute. The SAS SUPER ISO 180 is appropriate in Clean Rooms and other applications demanding fast sampling times. In Clean Rooms, for example, it is important to test larger volumes of air, because the microbial air contamination is very low.

The SAS SUPER ISO 180 reduces the required time to obtain a sample with an important saving of time. Both SAS SUPER ISO 100 and SAS SUPER ISO 180 are identified by the “SAS SUPER ISO” logo on the front part of the instrument.

3. INSTALLATION 3.1 The practical use of plates

THE PRACTICAL USE OF “ PLATES” FOR AIR CONTROL SAS SUPER ISO 100TM SAS SUPER ISO 180TM

SAS SUPER ISO 100 & SAS SUPER ISO 180 FLOW SCHEME 1. 2. 3. 4.

Remove the aspirating head. Insert an identified, closed and prepared Plate and remove plate lid. Replace the aspirating head. Select required air flow and start the unit. The air flow is directed onto the agar surface of the Plate.

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5. 6. 7. 8.

At the end of the cycle, remove the aspirating head. Close and remove the Plate. Incubate. Count the colonies, record the results on the microbiological air sampling report and interpret results.

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The two air samplers have the same performances with the only difference being in the rate of air aspirated:

SCREEN INDICATIONS START MENU SELECT VOLUME PROGRAM VOLUME SET DELAY MULTIMODE

CONFIGURATION UTILITY MODE

POWER OFF

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DESCRIPTION This message indicates the air sampler is ready to repeat the same volume of prior sampling This message indicates the air sampler is programmed to enter the following Sub-Menus: With this function the volume of aspirated air can be modified according to 8 programmed values With this function the 8 programmed values can be modified With this function the air sampler can be programmed to start sampling after a programmable delay (1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 20, 30, 40, 50, 60 minutes) With this function the air sampler can be programmed to extend the total sampling time using “sequential interval time” sampling by these Sub Menus: INTERVAL TIME It can be programmed from 1 to 59 minutes NUMBERS OF RUNS They can be programmed from 1 to 19 air aspirations SINGLE RUN VOLUME It can be programmed from 1 to 1999 litres TOTAL RUNS It shows the total volume of aspirated air With this function you can use the sas with eight programmable configuration With this function the air sampler is programmed to enter the following SubMenu: SET TIME To program date and time SITE To identify the sampling point IDENTIFY To identify the operator’s name LANGUAGE To display text in different languages DISPLAY RECORD To show the recorded sampling data CLEAR RECORD To clear the recorded sampling data REMOTE CONTROL Not used CALIBRATION To calibrate the volume of aspirated air With this function the air sampler can be switched off by touching the ENTER button.

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3.2. List of menus and utility sub-menus

The apparatus is subject to specific working tests before shipping and it is carefully packed to avoid possible damage during transit. However, a visible check should be carried out as soon as possible to determine any transit damage. This must be reported immediately. The following procedures should be followed to check that the unit is functioning correctly. The battery pack of the instrument must be charged for at least 5 hours before the test

SAS SUPER ISO 100 & SAS SUPER ISO 180 After the screen is touched for at least two seconds, an automatic visual presentation appears. N:B: In the following displays, the entry of “XX” indicates numerical figures.

S-SAS XXX

S-SAS

Rev. X.X – X.XX S/N XX-XX-XXXX

DATE

SITE XXXXXXXX

XXXX Lt.

ID XXXXXXXX

TIME DELAY XX MIN

START

MENU

Touch START on the screen to start air sampling with the last cycle. The motor will run until the figures in the brackets reach the same figure as displayed to the right and then it will stop.

DATE

[ XXXX ]

START

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« Sas Super Iso 100/180 »

TIME

->

XXXX Lt.

STOP

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3.3 Preliminary Inspection

3.4 “55 mm Plates” Holder Adjustment

3.5

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The Plate holders can be adjusted (using a screw driver) in case the available plates slightly different in diameter from the standard 55 mm Plate (see Figure 1 page 26).

“84 mm Maxi- Plates”

If high fungal contamination is expected in the sampled air, Maxi- Plates are suggested. This is because moulds tend to spread and consequently make counting difficult after incubation. The “84 mm Maxi- Plates” are inserted into the SAS SUPER ISO 100 or SAS SUPER ISO 180 using a special adaptor (Cat.n. 19123). For more details see Application Note N. 89.

3.6 Petri head adapter (Optional) An adapter is available in aluminium or stainless steel which allows the use of standard 90 mm Petri Dishes with SAS.

3.7. 90 mm Petri Dishes filling We recommend to fill the standard 90 mm disposable Petri dish with no more than 18-20 ml of agar to avoid that the medium can touch the inside surface of the aspirating head.

3.8 Tripod Installation (Optional) The SAS SUPER ISO 100 & SAS SUPER ISO 180 can be fixed to a table tripod or a floor tripod or a wall . The screw thread connection is located under the unit, between the two front feet. When not in use, the connection cavity is protected by a metal screw insert.

head

55 mm Plate standard version

head 84mm Maxi Adaptor

Maxi System

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4. SOFTWARE FUNCTION

The air sampler is provided with eight programmable air volumes (“Select volume”) stored in the memory and eight sampler configuration (“Configuration”) selected by the operator. The selection of the volume is made by pressing the “UP” or “DOWN” arrows when the program is in the relevant sub-menu. The following volumes of air are suggested: - Contaminated areas (communities, processing rooms, etc.) 10-200 litres of air - Normal areas (laboratory benches, houses, etc.) 200-500 litres of air - Sterile or high risk areas (clean rooms, operating theatres, etc.) 500-1000 litres of air.

SAS SUPER ISO 100 & SAS SUPER ISO 180 4.1. To start with the same air volume as the previous sample

Switch on the unit by touching the screen for at least two seconds. After the visual display presentation you will see the following display with the last aspirated volume of air

Time Date 08/31/06 500 Lt. Last aspirated volume of air

11.31

Battery Status

DELAY 00 MIN

START

MENU

Last delay time set

Touch START on the screen to start air sampling with the last cycle. The motor will run until the figures in the brackets reach the same figure as displayed to the right and then it will stop.

08/31/06 [ 0023 ] Current aspirated volume of air

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START

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11.31

->

0500 Lt.

STOP

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Target volume of air

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Touch the screen for at least two seconds to switch on the unit.

Switch on the unit by touching the screen for at least two seconds. After the visual display presentation you will see the following display with the last aspirated volume of air

08/31/06

11.31

500 Lt.

DELAY 00 MIN

START

MENU

Touch MENU and select SELECT VOLUME function by touching "UP" or "DOWN" arrows

MENU' SELECT VOLUME CLEAR

ENTER

Touch ENTER and select a volume by touching "UP" or "DOWN" arrows (for example 1250 Litres)

SELECT VOLUME [ 1250 ] Litres CLEAR

ENTER

Touch ENTER to select the volume, the display will show the selected volume

08/31/06 1250 Lt.

START

11.31 DELAY 00 MIN

MENU

Touch START to aspirate the selected volume of air

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4.2 . SELECT VOLUME function (To start with one of the eight memorized volume)

4.3 UTILITY MODE function

ENGLISH

In this program the following SUB-MENUS are listed: Set time, Site, Identify, Language, Display Record, Clear Record, Remote Control, Calibration. Always start from UTILITY MODE to reach one of these SUB-MENUS. Switch on the unit by touching the screen for at least two seconds. Touch MENU and select UTILITY MODE function by touching "UP" or "DOWN" arrows

MENU' UTILITY MODE CLEAR

ENTER

Touch ENTER to enter the sub-menu 4.3.1. “SET TIME” This option is used to program day, month, year and time of the day

UTILITY MODE SET TIME CLEAR

ENTER

Touch ENTER to modify the time

MM/DD/YY HH:mm 08/31/06 ^^

11:33

CLEAR

ENTER

Change the number indicated by "^^" by touching "UP" or "DOWN" arrows and touch ENTER to go to the next number.

MM/DD/YY HH:mm 08/31/06 ^^

11:33

CLEAR

ENTER

repeat until you reach the last number and the confirm by touching ENTER. International pbi S.p.A.

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This option is used to memorize the name of the site in the file “DISPLAY RECORD” (see paragraph 4.3.5). The site identification should be changed for samples taken at different sites especially if the results are to be printed. Select SITE function from UTILITY MODE Program.

UTILITY MODE SITE CLEAR

ENTER

Touch ENTER to modify the site

SITE [ ABCDEFGH ] ^ CLEAR

ENTER

Change the figure indicated by "^" by touching "UP" or "DOWN" arrows and touch ENTER to go to the next figure.

SITE [ SBCDEFGH ] ^ CLEAR

ENTER

repeat until you reach the last figure and the confirm by touching ENTER.

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4.3.2. “SITE”

This option is used to identify the operator. This should be changed if different operators use the sampler and especially if the date is to be printed. The data is recorded in the file “DISPLAY RECORD” (see paragraph 4.3.5). Select IDENTIFY function from UTILITY MODE Program.

UTILITY MODE IDENTIFY CLEAR

ENTER

Touch ENTER to modify the identity

IDENTIFY [ 12345678 ] ^ CLEAR

ENTER

Change the figure indicated by "^" by touching "UP" or "DOWN" arrows and touch ENTER to go to the next figure.

IDENTIFY [ 3234578 ] ^ CLEAR

ENTER

repeat until you reach the last figure and the confirm by touching ENTER.

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4.3.3. “IDENTIFY”

ENGLISH

4.3.4. “LANGUAGE” The text of the Menus may be selected choosing from different languages. Select LANGUAGE function from UTILITY MODE Program.

UTILITY MODE LANGUAGE CLEAR

ENTER

Touch ENTER to modify the language

LANGUAGE ENGLISH CLEAR

ENTER

Change the language by touching "UP" or "DOWN" arrows and touch ENTER to select the desired language; the display will be showed in the selected language. Touch CLEAR to exit this function.

4.3.5. “DISPLAY RECORD” The last 300 samples are memorized in the file “DISPLAY RECORD”. Each sample is identified in cronological date order and shows the date, time, operator, site and volume of air sampled (only after a completed run cycle). Select DISPLAY RECORD function from UTILITY MODE Program.

UTILITY MODE DISPLAY RECORD CLEAR

ENTER

Press ENTER to display the data

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Date End sampling time

001 08/31/06 BBCD/3345

Site/Identity

11.31 Lt. 1250 *

ENGLISH

DISPLAY RECORD

Record position number

Multimode indicator

CLEAR

Aspirated Liters You can view all the completed cycle by touching "UP" or "DOWN" arrows. The symbol "*" is displayed near the volume aspirated if the volume was aspirated with the multimode function. Touch CLEAR to exit this function.

4.3.6. “CLEAR RECORD” This option is used to delete all the data memorized in the “DISPLAY RECORD”. Before starting this procedure, be sure that all stored data are not required or have been ed. Select CLEAR RECORD function from UTILITY MODE Program.

UTILITY MODE CLEAR RECORD CLEAR

ENTER

Press ENTER to delete the data

CLEAR RECORD CONFIRM CLEAR

ENTER

Touch ENTER to confirm the deletion of data or touch CLEAR to exit the function

4.3.7. “REMOTE CONTROL” The REMOTE CONTROL function is not operative.

4.3.8. “CALIBRATION” The “Calibration” function is a -protected menu accessible only by an authorized technician.

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4.4.

PROGRAM VOLUME function (modification of the value of a stored volume)

ENGLISH

Using this procedure, it is possible to memorise up to eight different volumes (from 1 to 1999 litres of air). Switch on the unit by touching the screen for at least two seconds. Touch MENU and select PROGRAM VOLUME function by touching "UP" or "DOWN" arrows

MENU' PROGRAM VOLUME CLEAR

ENTER

Touch ENTER to modify the volumes

SELECT VOLUME [ 1250 ] Litres CLEAR

ENTER

select a volume by touching "UP" or "DOWN" arrows and touch ENTER

MODIFY RUN [ 1250 ] ^ CLEAR

ENTER

Change the figure indicated by "^" by touching "UP" or "DOWN" arrows and touch ENTER to go to the next figure.

MODIFY RUN [ 0250 ] ^ CLEAR

ENTER

repeat until you reach the last figure and the confirm by touching ENTER. Note: The maximum air volume is 1999 Liters

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4.5.

Using a “SET DELAY” program to delay instrument start

ENGLISH

This function is used to set a delay time before the sampling cycle. Switch on the unit by touching the screen for at least two seconds. Touch MENU and select SET DELAY function by touching "UP" or "DOWN" arrows

MENU' SET DELAY CLEAR

ENTER

Touch ENTER to modify the delay time

SET DELAY [ 00 ] Minutes CLEAR

ENTER

select the desired delay time by touching the "UP" or "DOWN" button. The available delay time are 0-1-2-3-4-5-6-7-89-10-20-30-40-50-60 minutes. Touch ENTER to confirm. When a delay is set (for example 5 minutes) , on the main display you will see the delay time

08/31/06

11.31

0250 Lt.

DELAY 05 MIN

START

MENU

The message “DELAY” will flash until the selected time is reached. The display flashes to confirm delayed start has been selected.

08/31/06

11.31 **DELAY**

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MENU March 2007

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Switch on the unit by touching the screen for at least two seconds. Touch MENU and select MULTI MODE function by touching "UP" or "DOWN" arrows

MENU'

MULTI MODE CLEAR

ENTER

Touch ENTER to enter the multiode function

INTERVAL TIME

[ 00 ] Minutes ^ CLEAR

ENTER

select the desired interval time between sampling by touching the "UP" or "DOWN" button. Touch the ENTER button to go to the next digit. The interval time can be set from 0 to 59 minutes. Touch ENTER to confirm.

NUMBERS OF RUNS

[ 01 ] RUN ^ CLEAR

ENTER

select the desired numbers of sampling cycles by touching the "UP" or "DOWN" button. Touch the ENTER button to go to the next digit. The maximum nubers of cylce is 19. Touch ENTER to confirm.

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4.6. MULTI MODE function This program is very useful for extending the time of sampling with the purpose of obtaining a more representative environmental sample “in actual operating conditions”. The total air volume to be sampled is aspirated with two or more sub-volume aspirations (E.g.:1000 litres in ten runs of 100 litres at five minute intervals).Before entering the MULTI MODE Program you should therefore decide (a) total volume of air to be sampled onto the Plate; (b) number of runs; (c) interval time. See Application Note N.95 for more details.

SINGLE RUN VOLUME

CLEAR

ENGLISH

[ 0000 ] Litres ^ ENTER

select the desired volume of aspirated air for each sampling by touching the "UP" or "DOWN" button. Touch the ENTER button to go to the next digit. The maximum aspirated volume of cylce is 1999 Litres. Touch ENTER to confirm The display will show the TOTAL volume of air to be aspirated at the end of the cycles. Check if it is correct volume. If not, touch the CLEAR button and start again. For example if you set 5 cycle of 200 liters each you will aspirate 1000 liters of air

TOTAL RUN

[ 1000 ] Litres CLEAR

ENTER

Touching ENTER to confirm it will set the SAS in the multi mode

08/31/06

11.31 RUN 05 x 200 Lt.

START

MENU

Touch START to run the multimode

08/31/06 [ 0023 ]

11.31 ->

START

200 Lt.

STOP

At the end of the run the SAS will display a flashing delay before the next cycle; and the number of completed cycles and residual cycles (runs) are also displayed.

08/31/06

11.31

DELAY RUNS

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02/05

STOP March 2007

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CONFIGURATION function

4.7.1 To start with one of the eight operator programmable configuration memorised If the operator requires to use a preset configuration (composed of site, identity, numbers of runs, numbers of cycle) up to 8 additional configuration can be programmed into the unit. Switch on the unit by touching the screen for at least two seconds. Touch MENU and select CONFIGURATION function by touching "UP" or "DOWN" arrows

MENU' CONFIGURATION CLEAR

ENTER

Touch ENTER to enter the function

CONFIGURATION SELECT CLEAR

ENTER

select SELECT function by touching "UP" or "DOWN" arrows and touch ENTER

Record position number

Site/Identity

CONFIGURATION [1]

Start delay

ABCDEFGH/1234568 01 02 0111 0222

Numbers of cycle

CLEAR

Total air volume

Air volume per cycle

ENTER

select the preset configuration desired (between 1 and 8) by touching "UP" or "DOWN" arrows and touch ENTER to confirm Touch START to run the sampling cycle.

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4.7.

ENGLISH

4.7.2 Modify the of the eight operator programmable configuration memorised If you want to modify the preset configuration (composed of site, identity, numbers of runs, numbers of cycle) you must use the MODIFY function Switch on the unit by touching the screen for at least two seconds. Touch MENU and select CONFIGURATION function by touching "UP" or "DOWN" arrows

MENU' CONFIGURATION CLEAR

ENTER

Touch ENTER to enter the function

CONFIGURATION

MODIFY CLEAR

ENTER

select the SET function by touching "UP" or "DOWN" arrows and touch ENTER

MODIFY CONFIGURATION [1] CLEAR

ENTER

You must choose the configuration that you want to modify function by touching "UP" or "DOWN" arrows and touch ENTER; now you can modify the site name

SITE [ ABCDEFGH ] ^ CLEAR

ENTER

Change the figure indicated by "^" by touching "UP" or "DOWN" arrows and touch ENTER to go to the next figure.

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SITE ENGLISH

[ SBCDEFGH ] ^ CLEAR

ENTER

repeat until you reach the last figure and the confirm by touching ENTER; now you can modify the identity

IDENTIFY [ 12345678 ] ^ CLEAR

ENTER

Change the figure indicated by "^" by touching "UP" or "DOWN" arrows and touch ENTER to go to the next figure.

IDENTIFY [ 3234578 ] ^ CLEAR

ENTER

repeat until you reach the last figure and the confirm by touching ENTER; now you can choose to program the SAS in single mode or multimode.

INTERVAL TIME [ 00 ] Minutes ^ CLEAR

ENTER

select the desired interval time between sampling by touching the "UP" or "DOWN" button. Touch the ENTER button to go to the next digit. The interval time can be set from 0 to 59 minutes. Note: If you want to program a single cycle set INTERVAL TIME to 0 minutes Touch ENTER to confirm.

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NUMBERS OF RUNS [ 01 ] RUN ^ CLEAR

ENTER

select the desired numbers of sampling cycles by touching the "UP" or "DOWN" button. Touch the ENTER button to go to the next digit. The maximum nubers of cylce is 19. Note: If you want to program a single cycle set NUMBERS OF RUN to 1 Touch ENTER to confirm.

SINGLE RUN VOLUME [ 0000 ] Litres ^ CLEAR

ENTER

select the desired volume of aspirated air for each sampling by touching the "UP" or "DOWN" button. Touch the ENTER button to go to the next digit. The maximum aspirated volume of cylce is 1999 Litres. Touch ENTER to confirm The display will show the TOTAL volume of air to be aspirated at the end of the cycles. Check if it is correct volume. If not, touch the CLEAR button and start again. For example if you set 5 cycle of 200 liters each you will aspirate 1000 liters of air

TOTAL RUN [ 1000 ] Litres CLEAR

ENTER

Touch ENTER to confirm and save the configuration. See paragraph 4.7.1 for the procedure to run a preset configuration. 4.8. POWER OFF function With this function the instrument can be switched off. Touch MENU and select POWER OFF function by touching "UP" or "DOWN" arrows

MENU' POWER OFF CLEAR

ENTER

Touch ENTER to switch off the instrument. International pbi S.p.A.

« Sas Super Iso 100/180 »

March 2007

Rev. 3

25

Note: The instrument will automatically switches off after 5 minutes of idle mode

5.1 Adjustable “ Plate” holders The SAS SUPER ISO 100 and SAS SUPER ISO 180 air samplers are designed for use with standard “ Plates”. The plate holders are adjustable to allow different brands of Plates to be fitted.

FIG. 1 Adjustable plate holders in the sampler head allow the operator to use plates from many sources without concern for slight differences in plate size.

5.2 “ Plate” handling (a) Insure head has no obstructed holes (foreign matter, agar,etc). Hold up to light to visually inspect. (b) Disinfect the cover of the air sampler at the beginning of each sampling program treating the inside and the outside part with a disinfecting alcohol wipe or swab. (c) The cover with its protective plastic lid can be autoclaved at 121°C for 15 minutes. If this procedure is to be repeated regularly, a s/s head is reccomended. It is therefore useful to have available several heads ready to use. Alternatively, the unit can be sanitised using a disinfecting aerosol at about 30 cm from the head when the fan is running. Thirty seconds are sufficient to disinfect the air path. (d) Remove the cover of the air sampler by unscrewing it, holding the edge of the cover. Avoid touching the inside and outside of the drilled area. (e) Insert a closed filled “ Plate” into the retaining slots and then remove its lid. Avoid contamination from droplets and aerosol infection. (f) Replace the sampling head and start the air aspiration cycle. At the end of the cycle, unscrew the sampling head, replace the “ Plate” lid and remove the “ Plate”. (g) Be sure each “ Plate” is identified with the appropriate sample data. (h) Incubate the “ Plate” for the specified time at the appropriate temperature. (i) At the end of incubation count the number of visible organisms (C.F.U.) and relate this number to the volume of air sampled.

International pbi S.p.A.

« Sas Super Iso 100/180 »

March 2007

Rev. 3

26

ENGLISH

5. OPERATIONS

Sanitation of the air sampler

A. COVER OF THE HEAD The sampling head with its protective plastic lid can be autoclaved at 121°C for 15 min. Alternatively, the sampling head can be sanitised by treating the inside and outside surfaces with a disinfecting alcohol wipe or swab.

B. PLATE HOUSING HEAD The unit complete with the sampling head can be sanitised using a disinfecting aerosol (e.g.: Isopropyl alcohol sterile spray cod. 18223) held at about 30 cm from the head when the fan is running. 30 seconds are sufficient to disinfect the air path. C. BODY OF THE UNIT The plastic body of the unit can be wiped with a mild chemical agent.

5.4. Use of the air sampler in Clean Areas The sampling head should be autoclaved and the body of the unit wiped with a mild chemical disinfecting agent. NB: The air sampler is a scientific instrument and its surface should be disinfected using an aerosol or a damp cloth. Liquid should not be applied directly ! The unit should be protected with a sterile bag and then transferred into the Clean Area. It is important to wear sterile gloves when handling the “ Plates” and the head of the air sampler to prevent bacteriological contamination. Use double or triple packed, gamma irradiated “ Plates” to avoid possible clean environment contamination. For more details see Application Notes N.15, 31, 55, 63, 68, 83, 95, 99.

International pbi S.p.A.

« Sas Super Iso 100/180 »

March 2007

Rev. 3

27

ENGLISH

5.3.

5.6 Total Bacterial Count and/or micro-organisms identification by dilution In normal conditions, if sampling is correctly performed, the colonies are easily counted and collected for identification on the agar surface of the Plate. If very high colony count is expected, if inhibitors are expected in the air being sampled or if the micro-organisms are to be incubated at different temperatures, the dilution method should be applied. The total amount of agar of the Plate is aseptically transferred to a Stomacher bag, sterile diluent is added and the Somacher treatment is applied for one minute. The usual plating technique and/or identification procedures are applied to the processed diluent.

5.7 Multi Point Sampling with several independent air samplers A progressive simultaneous operation monitoring in a closed environment can be organised using several SAS Super ISO 100 / SAS SUPER ISO 180 air samplers programmed with different starting delay times and sequential interval steps. The air samplers can be positioned on a different walls using a arm (cat. n. 19834) to allow 45°C inclination. At the end of operation, the air samplers are collected for Plate transfer and / data export to paper by printer or PC. This type of organisation allows: (a) to reduce staff labor involved in sampling; (b) to reduce microbial contamination risk because the enclosed environment is monitored “in operation” ; (c) to obtain complete written report on air sampling.

AREA

Position

SAS s/n

Single Air Total Air Sub Sample Sampling Volume Volume number interval

Start delay

A

A1

1.210

-

1.000

-

-

5

A2

1.211

200

1.000

5

30

-

A3

1.213

250

1.000

4

30

-

B1

1.214

250

1.000

4

30

-

B2

1.215

200

1.000

5

30

-

C1

1.216

-

1.000

-

-

20

B C

(a) Air sampler SAS SUPER ISO 100 Serial Number 1210 was positioned in AREA A on site A1 and programmed for a total air volume of 1000 litres in one run, starting after 5 minutes from the switching on of the instrument. (b) Air sampler SAS SUPER ISO 100 Serial Number 1211 was positioned in AREA A on site A2 and programmed for a total air volume of 1000 litres in five times (200 litres during each run) with interval times of 30 minutes. (c) Air sampler SAS SUPER ISO 100 Serial Number 1213 was positioned in AREA A on site A3 and programmed for a total air volume of 1000 litres in four times (250 litres during each run) with interval times of 30 minutes. (d) Air sampler SAS SUPER ISO 100 Serial Number 1214 was positioned in AREA B on site B1 and programmed for a total air volume of 1000 litres in four times (250 litres during each run) with interval times of 30 minutes. (e) Air sampler SAS SUPER 100 ISO Serial Number 1215 was positioned in AREA B on site B2 and programmed for a total air volume of 1000 litres in five times (200 litres during each run) with interval times of 30 minutes. (f) Air sampler SAS SUPER 100 ISO Serial Number 1216 was positioned in AREA C on site C1 and programmed for a total air volume of 1000 litres in one run, starting after 20 minutes from the switching on of the instrument.

International pbi S.p.A.

« Sas Super Iso 100/180 »

March 2007

Rev. 3

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ENGLISH

5.5. “ Plates” preparation It is important that the volume of media dispensed into a “ Plate” is constant for the type of plate used. An excess volume can create a convex surface that is too high and which may touch the inside of the sampler head. An insufficient volume will create a concave surface, unsuitable for representative colony growth using SAS System. The volume of agar in a “55 mm Plate” should be 16-18 ml and in a ”84 mm Maxi- Plate” 24-26 ml. For more details see Application Note N.78.

5.9. Final Operations Switch off the unit by touching the STOP message during the sampling cycle or touching first MENU and then the arrow to reach Power Off message; press ENTER to confirm. The unit will switch off automatically after 5 minutes. 6. CALCULATION OF RESULTS 6.1. Colony Forming Units per 1000 litres of air The number of organisms counted on the surface of the “ Plate” must first be corrected for the statistical possibility of multiples particles ing through the same hole. The statistical formula is taken from work by J. Macher. Correction Tables are given below for both the 55 mm standard head, the 84 mm Maxi- head and the Petri head. The probable count (Pr) is then used to calculate the Colony Forming Unit (CFU) per cubic metre of air sampled.

CORRECTION TABLE TO ADJUST COLONY COUNTS FROM A 219-HOLE IMPACTOR USING STANDARD 55 mm PLATES AND 90mm PETRI PLATES Colonies r

MPN Pr

Colonies r

MPN Pr

Colonies r

MPN Pr

Colonies r

MPN Pr

Colonies r

MPN Pr

Colonies r

MPN Pr

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 37 38 39 40

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 17 18 19 20 21 22 23 24 25 26 28 29 30 31 32 33 34 36 37 38 39 40 42 43 44

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 73 74 75 76 77 78 79 80

45 46 48 49 50 51 53 54 55 57 58 59 60 62 63 64 66 67 69 70 71 73 74 76 77 78 80 81 83 84 86 87 88 90 92 93 95 96 98 99

81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120

101 102 104 106 107 109 110 112 114 116 117 119 121 122 124 126 128 130 131 133 135 137 139 141 142 144 146 148 150 152 154 156 158 160 162 165 167 169 171 173

121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160

175 178 180 182 185 187 189 192 194 196 199 201 204 206 209 212 214 217 220 222 225 228 231 234 237 240 243 246 249 252 255 258 261 265 268 271 275 278 282 286

161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200

289 293 297 301 305 309 313 317 322 326 331 335 340 344 349 354 359 365 370 375 381 387 393 399 405 412 418 425 432 439 447 455 463 471 480 489 499 508 519 530

201 202 203 204 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219

542 554 567 580 595 611 627 646 666 687 712 739 770 807 851 905 978 1088 1307

r = colony forming units counted Pr = probable count

International pbi S.p.A.

« Sas Super Iso 100/180 »

March 2007

Rev. 3

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ENGLISH

5.8 Multi Point Sampling with several connected air samplers Several SAS Super ISO 100 air samplers can be connected and controlled by PC.

Colonies r

MPN Pr

Colonies r

MPN Pr

Colonies r

MPN Pr

Colonies r

MPN Pr

Colonies r

MPN Pr

Colonies r

MPN Pr

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 37 38 39 40

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 40 41 42

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 73 74 75 76 77 78 79 80

43 44 45 46 47 48 49 50 52 53 54 55 56 57 58 59 61 62 63 64 65 66 67 69 70 71 72 73 74 75 77 78 79 80 81 83 84 85 86 87

81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120

88 90 91 92 93 95 96 97 98 99 101 102 103 104 106 107 108 109 111 112 113 114 116 117 118 119 121 122 123 125 126 127 128 130 131 132 134 135 136 138

121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160

139 140 142 143 144 146 147 148 150 151 152 154 155 157 158 159 161 162 163 165 166 168 169 171 172 173 175 176 178 179 181 182 183 185 186 188 189 191 192 194

161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200

195 197 198 200 201 203 204 206 207 209 210 212 213 215 217 218 220 221 223 224 226 228 229 231 232 234 236 237 239 241 242 244 245 247 249 250 252 254 255 257

201 202 203 204 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 221 222 223 224 225 226 227 228 229 230 231 232 233 234 235 236 237 238 239 240

259 261 262 264 266 267 269 271 273 274 276 278 280 281 283 285 287 289 290 292 294 296 298 300 301 303 305 307 309 311 313 315 317 318 318 320 322 324 326 330

Example of calculation of results Pr x 1000 X =---------------------V Where: V = Volume of sampled air = 200 litres of air r = Colony Forming Units counted on “ 55 mm Plates” = 67 Pr = Probable count obtained by positive hole correction = 80 x = Colony Forming Units per 1000 litres (= 1 cubic metre) of air 80 x 1000 x = ------------------------- = 400 CFU per 1000 litres of air (1000 litres=1m3) 200 To express the final result in CFU/ft3 multiply the CFU/m3 value by 0,02832 [Note: conversion formula = 1 cubic Foot = 28.32 litres]

International pbi S.p.A.

« Sas Super Iso 100/180 »

March 2007

Rev. 3

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ENGLISH

CORRECTION TABLE TO ADJUST COLONY COUNTS FROM A 487-HOLE IMPACTOR USING 84 mm MAXI- PLATES

CORRECTION TABLE TO ADJUST COLONY COUNTS FROM A 401- HOLE IMPACTOR USING STANDARD 90mm PETRI PLATES r 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 37 38 39 40 41 42 43 44

Pr 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 22 23 24 25 26 27 28 29 30 31 32 33 34 35 37 38 39 40 41 42 43 44 45 47

r 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 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89

International pbi S.p.A.

Pr 48 49 50 51 52 53 54 56 57 58 59 60 61 63 64 65 66 67 68 70 71 72 73 74 76 77 78 79 80 82 83 84 85 87 88 89 90 92 93 94 95 97 98 99 100

r 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134

Pr 102 103 104 106 107 108 110 111 112 114 115 116 118 119 120 122 123 124 126 127 128 130 131 133 134 135 137 138 140 141 142 144 145 147 148 150 151 152 154 155 157 158 160 161 163

« Sas Super Iso 100/180 »

r 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179

Pr 164 166 167 169 170 172 173 175 177 178 180 181 183 184 186 188 189 191 192 194 196 197 199 201 202 204 206 207 209 211 212 214 216 217 219 221 223 224 226 228 230 231 233 235 237

r 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 221 222 223 224

Pr 239 240 242 244 246 248 250 251 253 255 257 259 261 263 265 267 269 271 272 274 276 278 280 282 284 287 289 291 293 295 297 299 301 303 305 307 310 312 314 316 318 321 323 325 327

March 2007

r 225 226 227 228 229 230 231 232 233 234 235 236 237 238 239 240 241 242 243 244 245 246 247 248 249 250 251 252 253 254 255 256 257 258 259 260 261 262 263 264 265 266 267 268

Pr 330 332 334 336 339 341 343 346 348 351 353 355 358 360 363 365 368 370 373 375 378 380 383 386 388 391 393 396 399 402 404 407 410 413 415 418 421 424 427 430 433 436 439 442

r 269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 288 289 290 291 292 293 294 295 296 297 298 299 300 301 302 303 304 305 306 307 308 309 310 311 312

Rev. 3

Pr 445 448 451 454 457 460 463 466 470 473 476 479 483 486 489 493 496 500 503 507 510 514 517 521 525 528 532 536 540 544 548 551 555 559 563 568 572 576 580 584 589 593 597 602

r 313 314 315 316 317 318 319 320 321 322 323 324 325 326 327 328 329 330 331 332 333 334 335 336 337 338 339 340 341 342 343 344 345 346 347 348 349 350

Pr 606 611 616 620 625 630 635 639 644 649 654 660 665 670 675 681 686 692 698 703 709 715 721 727 733 740 746 752 759 766 772 779 786 794 801 808 816 823

r= colony forming units counted Pr= probable count

31

ENGLISH

6.2. Data recording All data related to instrument identification, operator’s name, sampling site, date and hour of sampling, type of media, CFU may be reported on the specific software.

ENGLISH

SECTION THREE 7. SPECIFICATIONS Principle Air-borne micro-organisms are collected on microbiological agar by impaction produced by aspiration. Nominal Air Flow Rate SAS SUPER ISO 100 = 100 litres of air per minute SAS SUPER ISO 180 = 180 litres of air per minute

Range of Air Sample Volume Eight air sample -programmable volume can be memorized (Select volume); Eight air sample -programmable SAS configuration (air volum, site,identity,number of run, volume of single run) can be selected and memorised by the operator (Configuration). Maximum volume of air per single cycle is 1999 litres. Voltage 8,4 Volts – 2,7 amp/h Battery Pack Rechargeable Nickel Metal Hydride (without memory effect). Battery Autonomy Aspiration of approx. 70.000 litres of air Motor 6 Volts, 2,8 Watts Size 120x125x275 mm Weight 1850 g Construction Aspirating Head: aluminium or stainless steel Turbine: antistatic plastic resin Housing: polyurethane resin Acoustic signal An acoustic signal alerts the operator each time the screen has been touched and command accepted and at the end of each aspirating cycle. 3,0 Volts Flat Battery Date and hours are updated, even when air sampler is switched off, by a 3,0 Volt flat battery. The instrument should be switched on during the 3,0 Volt flat battery replacement, to avoid loosing date and hours.

International pbi S.p.A.

« Sas Super Iso 100/180 »

March 2007

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1 Adjustable holders to accommodate “ Plates” of different diametres 2 Air turbine 3 Plate fixing spring clip

1

3

FIG.2

2

SAS Super ISO 100 / SAS Super ISO 180 Rear

4 Feet for sampling in upright position 5 Infrared window for PC connection 6 Battery charger connection

4 6

5

International pbi S.p.A.

« Sas Super Iso 100/180 »

FIG. 3

March 2007

Rev. 3

33

ENGLISH

SAS Super ISO 100 / SAS Super ISO 180 Plate Chamber

ENGLISH

SAS Super ISO 100 / SAS Super ISO 180 Front Control

7 Infrared sensor for remote control 8 Touch screen display

7

8

FIG. 4

SAS Super ISO 100 / SAS Super ISO 180 Bottom

9 10

Protecting screw cap for tripod connection Instrument feet

9

10

International pbi S.p.A.

FIG. 5

« Sas Super Iso 100/180 »

March 2007

Rev. 3

34

Sampling time required for different air volumes

SAS SUPER ISO 100 LITRES OF AIR 50 100 200 300 400 500 600 700 800 900 1000

7.2.

SAS SUPER ISO 180

TIME REQUIRED 30 seconds 1 minutes 2 minutes 3 minutes 4 minutes 5 minutes 6 minutes 7 minutes 8 minutes 9 minutes 10 minutes

LITRES OF AIR 90 180 360 540 720 900 1000

ENGLISH

7.1.

TIME REQUIRED 30 seconds 1 minute 2 minutes 3 minutes 4 minutes 5 minutes 5 minutes 30 seconds

Battery charger operations

When the battery charge is not enough to start a cycle, the instrument will show the following flashing message: 08/31/06

11.31

LOW BATTERY !!

START

MENU

The air sampler must be charged 1. Switch off the unit. 2. Connect the smaller plug of the battery charger to the battery socket on the SAS SUPER ISO 100 or SAS SUPER ISO 180. 3. Connect the battery charger to the main supply (220 or 110 Volts): that the RED LED on the charger is lit correctly (see label on charger). 4. The air sampler is recharged after 5 hours using the supplyied battery charger 5. Disconnect the battery charger from the mains supply. 6. At the end of operation, disconnect the battery charger plug from the socket of the air sampler. NOTES (a) The correct metal hydride battery charger must be used to charge the SAS SUPER ISO 100 or SAS SUPER ISO 180! (b) If the air sampler has not been used for several weeks, check the battery status! (c) The efficiency of the battery is reduced when operating at temperatures below 0 °C. ƒ ƒ ƒ ƒ

Battery performance will degrade at extreme temperatures like +60° or – 20 °C. The Metal Hydride battery has a self-discharge rate and, without use, will lose about 2% of its charge per day. To prevent injury or burns, do not allow metal objects to or short circuit the battery terminals. The Metal Hydride battery may explode if disposed in fire. Use acceptable method for disposing of batteries.

7.3. Automatic switch off The instrument will automatically switch off after 5 minutes to save the battery. International pbi S.p.A.

« Sas Super Iso 100/180 »

March 2007

Rev. 3

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7.5. Automatic Flux Control The SAS is equipped with a special flux sensor. If there is a flux variation during the sampling (because of an obstruction or beacuse of the abscnce of Plate), the display will show:

08/31/06

11.31 FLUX ERROR !

START

MENU

Check for air path obstruction or presence of Plate and repeat the cycle.

7.6. Calibration Reminder If the calibration is expired, when you turn on the instrument the followin screen will be displayed:

08/31/06

11.31

CALIBRATION EXPIRED CLEAR

This message remind you that you should send the instrument to International PBI or authorized dealer for calibration; however touching CLEAR will let you use the instrument.

International pbi S.p.A.

« Sas Super Iso 100/180 »

March 2007

Rev. 3

36

ENGLISH

7.4. Sampling at high altitude over the sea level The aspirated volume of air at high altitude could be different from the the declared instrument figures due to the different barometric pressure and temperature. It is therefore necessary to re-validate the instrument at this specific altitude to know the true value of aspirated air. The re-validation is performed using the “Pyramid” Unit. (See chapter 8.2)

SECTION FOUR 8.1 Cleaning The SAS SUPER ISO 100 and SAS SUPER ISO 180 do not require special care and maintenance procedures. Clean the outside surface with a normal mild NON CORROSIVE detergent. ƒ ƒ ƒ ƒ

To clean the instrument you can use Isopropilic alchool (30% concentration), Sodium Ipoclorite (0,5% concentration), Hydrogen Peroxide (3%-6% concentration) Clean the air sampler with a soft damp cloth and a mild detergent. Do not use harsh abrasives. Do not submerge in water; do not pour or spray water directly on the air sampler. Do not use acetone or other volatile solvents for cleaning.

8.2 Validation and Calibration The motor speed and consequently the air flow are related to the electrical power supply, motor bearing conditions, etc. It is therefore suggested that the unit should be validated at least every six/twelve months. The validation of the air flow rate should be done by a certified anemometer in a wind tunnel. This type of certification may be performed by PBI International or an official PBI distributor. NOTE: The “Pyramid kit” is to be used for internal validation only (i.e. to the correct working conditions of the air sampler). When an Official Calibration is requested, a certified anemometer must be used to meet the required traceability characteristics (i.e. FDA inspections require a Calibration Certificate that is traceable to know standard such as the NIST).

International pbi S.p.A.

« Sas Super Iso 100/180 »

March 2007

Rev. 3

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ENGLISH

8. MAINTENANCE

8.4 Calibration frequency Generally, if instruments are used daily, calibrations should be performed every 6 months. Monthly or interval weekly usage require annual calibrations. 8.5 Trouble shooting – problems and actions PROBLEM Unit does not start

SUGGESTED ACTION - Touch the screen for at least two seconds - Recharge battery - Check the battery charger - Replace battery. Battery discharges after few minutes - Recharge battery working - Check the battery charger - Replace the charger or battery “LOW BATTERY” message - Recharge battery “FLUX ERROR” message - Check if air path is obstructed - Check if plate is in position - Send the instrument to PBI or an authorized dealer “CALIBRATION EXPIRED” - Send the instrument to PBI or an authorized dealer message Infrared remote switch doesn’t switch - Replace infrared remote battery on the unit Microbiological media is dehydrated - Control expiration date of media and that the agar is not dehydrated before after sampling sampling

8.6 Accessory list Accessories Cat.n. 15931 Cat.n. 15503 Cat.n. 19123 Cat.n. 18148 Cat.n.19117 Cat.n.19119 Cat.n.19115 Cat.n. 6064 Cat.n.19239 Cat.n. 5214 Cat.n. 5215 Cat.n.20153 Cat.n.18143 Cat.n.18950 Cat.n.19834 Cat.n.20093 Cat.n.20094

55 mm aluminium certified drilled head 55 mm stainless steel certified drilled head 84 mm aluminium certified drilled head complete with adaptor for Maxi Plate 84 mm stainless steel certified drilled head – complete with adapter for Maxi Plate 90 mm aluminium standard Petri dish head and adaptor 90 mm stainless steel standard Petri dish head and adaptor Atrium chamber for Clean Room application Autoclavable plastic cover for sampling head Compressed air head Table tripod Floor tripod Aluminium carrying case Soft carrying case Infrared remote control “ARM” System to fix SAS Super ISO 100 to wall Installation Qualification manual Operator Qualification manual

Control and Validation Systems Cat.n. 86666 Pyramid

International pbi S.p.A.

« Sas Super Iso 100/180 »

March 2007

Rev. 3

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ENGLISH

8.3 Performance routine monitoring The SAS SUPER ISO 100, SAS SUPER ISO 180 may be checked monthly / bimonthly (depending how often they are used) using the “Pitot Kit” or “PYramid” units to monitor that they are working correctly and their performances has not been affected by bad handling or damage. (See chapter 8.2)

CAT N° 5210 7426 17354 17573

TYPE PCA 60 PCA TW 60 TSA TW 60 SDA TW 60

7427

Gram 60

DESCRIPTION With “Plate Count Agar” for total viable count With “Plate Count Agar” and neutralizing agent for total viable count With “Tryptone Soy Agar” and neutralizing agent for total viable count With “Sabouraud Dextrose Agar” for fungi (yeasts and moulds) count and neutrilizing agent for total viable count With “Violet Red Bile Agar” for gram negative count

PACK 80 80 80 80 80

Cat.n. 19810 Surfair Plate - Empty Plates

SECTION FIVE AIR SAMPLER IDENTIFICATION SHEET ACCORDING TO EN 17025 According to the Document EN 17025, to apply the current Good Laboratory Practice, it is necessary to identify each instrument with a specific sheet. An example is here reported.

EN45001 Instrument Identification Sheet

Form n.

XXXX

Date

XXXX

Company / Institute

XXXX

Laboratory

XXXX

Name of Instrument

Microbiological Air Sampler

Model

SAS SUPER ISO 100

Serial Number

XXXX

Name of Producer

International pbi

Name of Distributor

XXXX

Condition at the moment of arrival

(X) new; (x) used; (x) reconditioned

Date of Arrival

/

/

Date of initial use

/ /

Usual collocation

Room XXXX

Servicing details

See servicing POS

Instrument to be calibrated

(X) Yes; (X) No

Periodic Calibration

(X) monthly; (X) quaterly; (X) Yearly

Instrument to be validated

(X) Yes; (X) No

Periodic Validation

(X) half year; (X) yearly

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« Sas Super Iso 100/180 »

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Rev. 3

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ENGLISH

Consumables “AGAR ” READY TO USE MEDIA FILLED STERILE PLATES

To the attention of: Technical department International pbi S.p.A. Via Novara, 89 - 20153 - Milano - Tel + 39 02/48.779.1-Fax +39 02/400.900.10 ENGLISH

AUTHORISATION RETURN NUMBER TO BE ASKED TO THE EXPORT DPT Company: Address: City:

Zip Code

Phone

Fax

State

Email

Name to : Lab/Division: † return

† request of technical service

Equipment: Model for

Serial Number:

† calibration

† repair

† other (specify)

NOTE OF MALFUNCTIONING † ELECTRICAL PART

† ELECTRONICAL PART

† MECHANICAL PART

† HYDRAULICS PART

NOTES:

ATTENTION: THE INSTRUMENT MUST BE SENT TO INT.PBI C/O STATIM VIA SAN GIUSTO 85 20153 MILANO ITALY SIGNATURE

NAME

DATE Mod. PQ09.9

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« Sas Super Iso 100/180 »

March 2007

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ENGLISH International pbi S.p.A.

« Sas Super Iso 100/180 »

March 2007

Rev. 3

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WARRANTY CONDITIONS International pbi warrants this product to be free of defects in materials and functionality The repairs will be effected by International pbi or by authorized dealers as follows: -

Faulty components free replacement The labour is always at customer's expense The equipment will be sent at buyer's expenses and risk and the return will be ex-works This warranty does not apply to damages resulting from tamperings,abnormal use and installation and does not cover transport damages International pbi shall not be liable for any commercial damages, whether incidental, consequential or otherwise derived from the use of instruments

ATTENTION TO OUR NEW CUSTOMER As a of our equipment you are covered for a 12 months guarantee for all spare parts as a result of mechanical failure of the machine during normal use. In order to provide you with first class service, it is essential for us to know all your references and which equipment you have. We kindly ask you therefore to fill in the attached guarantee and return the card to us by first class mail. A NOTRE NOUVEAU CLIENT En tant que utilisateur de notre appareil vous êtes couvert par une garantie de 12 mois pour toutes pièces de recharge eventuelles resultant de defauts mecaniques en utilisation normale. Dans le but de vous fournir un service impeccable il est essenciel que nous sachions qui vous êtes, ou vous êtes situes et quel equipment vous possedez. Voudriez vous remplir cette carte de garantie et nous la retourner. Le service PBI peut vous proposer un service d’entretien vous assurant un fonctionnement parfait rapide en cas de panne. Votre distributeur local peut vous fornir tous renseignements au sujet de ce contrat d’entretien et des prix appliqués. FUR UNSERE NEUEN KUNDEN Für Benutzer unserer Apparate sind alle ersatzteilen die sich aus mechanischen Fehlern in normalen Gerbrauch ergeben., für zen Monate garantiert. Damit wir Ihnen einem erstklassigen Service dienen konnen, ist es unbedingnotwending, dass wir wissen wo Sie sind und welches Gerat Sie haben. Darum bitten wir Sie, die beiliegende Garantiekarte auszufullen, und Sie uns per Post zuzuschicken. PBI bietet Ihnen auch einen vorbeugenden Kundendienst, um dafur zu sorgen, dass Ihre Apparate zu allen Zeiten in Ordun sind, dass Sie regelmassig kontrolliert werden, einen Express –Krisen-Service, wenn ein Apparat ausfallt. Ihr Verkaufs Agent hat alle Details des Service Kontraktes und kann Ihnen Preise offerieren. A TODOS NUESTROS NUEVOS CLIENTES El equipo adquirido por Vd. Está garantizado por doce meses contra cualquier defecto de fabricación que pudiera producir avería durante el uso normal. Con el fin de poderle ofrecer un servicio eficiente, es esencial que sepamos su nombre o razón social, dirección y equipo adquirido. Para ello, rogamos que por favor rellene el certificado de garantía adjunto y nos lo envíe por correro certificado. PBI también puede ofrecer un servicio postventa de mantenimiento preventivo para mantener el perfecto estado de funcionamento de su equipo, asì como ofrecerle una atencion normal y un rapido servicio en el caso de que su equipo falle.

International pbi S.p.A.

« Sas Super Iso 100/180 »

March 2007

Rev. 3

42

ENGLISH

WARRANTY