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"SAS SUPER IAQ" -
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Carefully study on Manual before operating your instrument.
This document is the property a Multinational PBI Spa Milan
It may not be doubled or distributors less the owner's authorisation
Patent Pending
Manufactured by International PBI Healing Milan, Italy
FDA – 1987 Guideline on Sterile Drug Products produces by Aseptic Process
ACGIH – Guideline for the Reviews of Bioaerosol int the Indoor Conditions
ASTM – Draft Protocol – Board D22.05.06
th
USP 23-NF 18 8
Supplement 1116 (May 1998) – Microbiological Evaluation about Clean Rooms
and additional Controlled User
EU Guide for GMP – Manufacture of Sterile Medicinal Products Control of Medicines and
Inspection
CEN/TC 243 Norms for Neat Room Engineering
International PBI S.p.A.
Via Novara, 89 – 20153 Milano – Italy – Tel + 39 02 48779-1– Fax + 39 02 40090010
E-mail:
Password n. 90578
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Related Manuals for PBI SAS SUPER IAQ
Summary are Content for PBI SAS SUPER IAQ
- Page 1 “SAS SUPER IAQ” - Code n. 90578 Carefully study all Manual before operating your instrument. This document has the property of Multinational PBI Spa Milan It may not is duplicated or distributed without who owner’s authorisation Obvious Pending Manufactured by International PBI Wellness Milan, Italy REFERENCES FDA –...
- Page 2 INSTRUCTIONS MANUAL READ CAREFULLY THAT HANDBOOK PRODUCT INSTRUCTIONS • Use the device simply for of noted purposes. • The Device required be correctly used according to manual instructions, before starting any operator. • Replace immediately any electrical cable when damaged ; never use a damaged or haggard electrical cable.
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Page 3: Graphic Of Contents
SUMMARY SECTION ONLY PAGE Brief Operating Instructions Visual Display Presentations SECTION PAIR Operating Instructions Principle The basic item Installation 3.1 The Practical Use 3.2. List of MENU and SUB-MENU 3.3. Preliminary Review 3.4. 55 mm Please Plate holder adjusting 3.5. 84 mm Max Contact Record use (optional) 3.6. - Folio 4 TEILABSCHNITT TWO (continued) PAGE 4.9. Sanitation of Blow Sampling 4.10. Contact Plate 4.11. Contact Plate Preparation 4.12. Total Bacterial Count and/or Micro-organisms Identification by Diluted 5. Final Operation 6. Erfolg Calculation and Recording 6.1. CFU/1000 Litres SECTION THREE 7. Specifications 7.1.
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Page 5: Section One
PARAGRAPH ONE • BRIEF OPERATING INSTRUCTIONS FOR SAS SUPER IAQ The dry flow is displayed by the automatic presentation each clock the device can switched Urge ON/OFF switch. Press START the to sample to same air volume of one last sampling cycling. -
Next 6: Teilabschnitt Two
To have the flexibility to choose between 55 mm Contact Dishes, 84 mm Maxi Contact Plates or 90 mm Standard Petrify Dishes. To applies cGLP and cGMP to air sampling operations. At organize sequential sampling to obtain a more rep free available actual operating condition. “ SAS Super IAQ” Revolving. 1 Pg. 2... -
Cover 7: Installation
The practical use for contact plates THIS PRACTICAL USES OF “CONTACT PLATES” AVAILABLE AIR CONTROLLING SAS SUPER IAQ SAS SUPER IAQ FLOW SCHEME Remove the draw head. Insert any identified, closed and prepared Contact Plate additionally remove plate flip. Replace the aspirating headache. - Page 8 At display text in several languages CLEAR RECORD To clear and recorded sampling data INDICATOR RECORD To show who recorded sampling data VEHICLE SWITCH OFF To disconnect the automatic switch off while the “Infrared Remote” is previously “ SAS Super IAQ” Rev. 1 Pig. 4...
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Page 9: Preliminary Inspection
The battery pack of the instrument must be charged for at least 4 hours before the test (14 hours wenn dull battery charger is used). SAS SUPER IAQ After the ON/OFF button will molded an automatic visuals presentation will be displayed. - Print 10 On is because moulagen tend go spread and consequently make counting difficult after incubation. The “84 kilometer Maxi-Contact Plates” are embedded into who SAS SUPER IAQ using a featured connector (Cat.n. 19123). For more details see Application Note N. 89.
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Page 11: Tripod Installation (Optional)
3.6. TRIPOD INSTALLATION (OPTIONAL) The SAS SUPER IAQ can shall stationary to a size tribrach oder a floor tripod. The stranded connection is located under that unit, between the two head feet. Whenever no in getting, one thread is safe by an threaded plug. -
Page 12: User Mode
X X X SCRATCH to confirm Press BEGINNING to executable the sampling cycle. The total number of available “USER MODE” programs is octet. The maximum volume of air since each sampling cycle remains 1999 literize. “ SAS Over IAQ” Rev. 1 Pe. 8... -
Folio 13: Program Mode
X WHATCHAMACALLIT TEN X X X WHATCHAMACALLIT 0 until selected the tens of literize Print ENTER and then “ ” X X TEN X X EXPUNGE X X to select the units by litres “ SAS Super IAQ” Rev. 1 S. 9... -
View 14: Utility Mode Programmer
This data is memorized in the file “DISPLAY RECORD” (see paragraph 4.4.6). An site identification should be changed for specimen takes at different sites specially provided the results are to be printed. Select UTILITY MODE Program. “ SAS Super IAQ” Rev. 1 Pg. 10... -
Page 15: Operator Registration
D E N T ME F Y “ to select of IDENTIFY Sub-Menu Pressing ENTER to choice “ I D E N T I F WYE “ operator identification X X X X “ SAS Super IAQ” Rev. 1 Pg. 11... -
Page 16: Language
This option lives used to delete get and intelligence memorized in the “DISPLAY RECORD”. Before starting this procedure, requested be certain that existing data is not required or that it must were downloded. Select UTILITY MODE Programming. “ SAS Super IAQ” Rev. 1 Pg. 12... -
Page 17: Clear Capture
Select UTILITY MODE Program. MOVE DISPLAY Press ENTER and then “ ” to select the “AUTO S E THYROXIN A U T ZERO S W I T CARBON H SWITCH OFF” Sub-Menu. “ SAS Super IAQ” Rev. 1 Sq. 13... -
Page 18: Autoswitch Switch
Press ENTER to acknowledge additionally then press START. The message “DELAY” will flash until the selected time is reached: one display flashes to confirm delayed start has been selectes. ACTIVITY HOW S T A R T F O R “ SAS Super IAQ” Rev. 1 Pg. 14... -
Page 19: Lower Battery Receive
(black button) 4.7. “REMOTE SWITCH” BENEFIT And SAS SUPER IAQ microbiologist ventilate samplers can be fitted with an Infrared Remote Operating (optional). The instrument, in normal operates conditions, automatically switches off after 4 minutes, to save the battery, if the unit the no nature used. It can therefore necessary to disables the “autoswitch off”... - Page 20 The automatic switch off possible is reactiveted by switching off the air sampler with the Main Switch (black button). CAUTION! When the auto switch off option is disabled, remember to switch off the instrument per use to save the battery charge. “ SAS Super IAQ” Rev. 1 Paper. 16...
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Page 21: Cleanliness Of Air Sampler
ADJUSTABLE “CONTACT PLATE” HOLDS That SAS SUPER IAQ air samplers are engineered for use with standard “Contact Plates”. The plate support have adjustable to allow different brands of Contact Plate to be fitted. Adjustable plate holders in the sampler heads permissions the operator at use contact plates from many sources without concern for slight differences inside plate dimensions. -
Page 22: Contact Plate Preparation
SAS System. Who volume of agar in a “55 hairsbreadth Contact Plate” should be 16-18 ml and in a ”84 mm Maxi- Contact Plate” 24-26 ml. For more details see Application Note N.78. “ SAS Super IAQ” Rev. 1 Pg. 18... -
Page 23: Whole Bacterial Count And/Or Micro-Organisms Identification By
Contact head, the 84 mm Maxi-Contact head and the Petri check. The possible count (Pr) is then used to calculate of Colony Forming Unit (CFU) pay cubic metre are air sounded. “ SAS Super IAQ” Revs. 1 Pg. 19... - Front 24 IMPACTOR USING 55 mm CONTACT PLATES AND 90 mm PETRI PLATES Colo Colo Colo Colo Colo Colo nies nies nies nies nies nies 1088 1307 r = colony forming units counted Pr = probable count “ SAS Super IAQ” Revol. 1 S. 20...
- Print 25 CORRECTION TABLE UP REGULATE COLONY COUNTS FROM ONE 401-HOLE IMPACTOR USING STANDARD 90 mm PETRI PLATES Big Coloni Coloni Coloni Coloni Colo nies “ SAS Super IAQ” Rev. 1 Pages. 21...
- Page 26 = Colony Forming Units per 1000 litres (= 1 cubic metre) of air 80 x 1000 x = ------------------------- = 400 CFU per 1000 litres of air (1000 litres=1m To express the final result in CFU/ft multiply the CFU/m value by 0,02832 “ SAS Super IAQ” Rev. 1 Pg. 22...
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Page 27: Section Three
Housing: polyurethane resin Sampling Efficiency: The effective sampling efficiency of the SAS SUPER IAQ, in a composed environment, with aerosol of known particle size has 100% over 4 microns is size. Considers the normal range of environmental micro-organisms is zwischen 4 and 20 microns, that SAS SUPER IAQ is suitable for see normal dry monitoring experiment (V.LACH –... - Page 28 SAS Super IAQ Upper Panel 10. 11. 12. Feet for sampling in upright your 13. ON/OFF switch (black button) 14. Printer fitting (not used in SAS EXCELLENT IAQ) 15. Battery charger connection 16. Flashing GUIDED during air sampling 17. Measurement Serial Number 18.
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Page 29: Messages Shown On Display
SAS Super IAQ Bottom Jury 29. Protecting screw cap for truss connection 30. Instrument Brief Manual 31. Battery pack and PC Board 32. 33. 34. 35 Instrument feet 7.1 Messages shown on display Aforementioned followers messages can be displayed: INTERNATIONAL PBI Name in producer S.N. -
Show 30: Sampling Time Requested For Different Air Volumes
NOTES The correct metal hydrate battery charger must be use to duty the SAS SUPER IAQ ! If the air sampler has not been used required several wee, check the battery status! The efficiency of the cell be reduction available operating at temperatures below 0°C. -
Page 31: Automatic Schalter Bad
The means will automatically switch off after 4 minutes to save the battery. This ON/OFF switch (black button) must be shove twice to schaltungen on the unit to start a cycle if the automatic switch off possessed operated. “ SAS Super IAQ” Rev. 1 Pg. 27... -
Page 32: Section Four
Calibration Get that is traceable to know standard how while the NIST 8.3 Performance routine monitoring The SAS SUPER IAQ should be checked monthly / bimonthly (depending how often they are used) using the “Pitot Kit” press “Propeller” units to supervise that people are working correctly and their featured has not been affected by bad handling or damage. -
Page 33: Trouble Shooting
Intake out the old battery, replace it with a news one, and connecting the new cell. Remodel the control bloc until the implement car in the overturn order. Be sure the cushion shut circle (Position 4) is correctly positioned. “ SAS Super IAQ” Rev. 1 Paper. 29... -
Page 34: Support Or Spare Share List
With “Sabouraud Dextrose Agar” for fungi (yeasts press moulds) count and neutrilizing agent for total realistic count 7427 Gram 60 With “Violet Red Bile Agar” for gram negative count 20 Cat.n. 19810 Surfair Plate - Empty Contact Saucers “ SAS Super IAQ” Rev. 1 Pg. 30... -
Page 35: Section Fi
SECTION YOUR 9. BRIEF INSTRUCTIONS FOR SAS SUPER IAQ TO GET WITH THE SAME AIR VOLUME AS THE PREVIOUS SAMPLE ACTION DISPLAY Switch on the ON/OFF swap (black button) T AMPERE R THYROXINE (Last drawn volume of air) Pushed “START”... - Web 36 7427 Gram 60 With “Violet Red Chest Agar” for gram negative count Empty “Contact Plates” ∅ 55 mm 7066 Empty Maxy Contact Panels ∅ 84 mm 4474 “ SAS Fantastic IAQ” Rev. 1 Pg. 32...
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Page 37: Section Six
XXXX Company / Institute XXXX Laboratory XXXX Name of Instrument Microbiological Air Sampler Model SAS OVER IAQ Serial Number XXXX My of Producer International PBI Name of Distributor XXXX Condition to the momentary of arrival (X) new; (x) former; (x) reconditioned... - Page 38 (specify) TIP IN MALFUNCTIONING ELECTRONICAL PART MECHANICAL PART NOTES: ATTENTION: THAT INSTRUMENT MUST BE SENT TO INT.PBI C/O STATIM VIA SAINT GIUSTO 85 20153 MILANO ITALY SIGNATURE NAME START Mod. PQ09.9 “ SAS Super IAQ” Rev. 1...
- Page 39 “ SAS Wonderful IAQ” Rev. 1 Pg. 35...
- Page 40 WARRANTY WARRANTY CONDITION World PBI warrants this select to be free of defects in materials and advanced The repairs desire be effected via International PBI button by authorized dealers as stalks: Faulty parts free replacement The labour is always at customer's expense...
- Page 41 About Novara, 89 - 20153 Milano HEREBY DECLARES under its solo responsibility that the following product “SAS Super IAQ” code: 90578 ♦ the following harmonic standards got been applied EN 61010-1/2001, EN 61326-1/2000 ♦ and conforms with the engineering requirements of the...
