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Emtek P100 User Manual

Portable microbial air samplers
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Portable Microbial Air Samplers
P100 USERS MANUAL / FW 2.014 / DEC.2024.V03
P100 & P100ss
Users Manual
Contact Us for Customer Service and Technical Support
1500 Kansas Ave., Suite 4-C
Longmont, CO 80501
Website:
Phone:
Email:
EMTEK, LLC 
http://www.emtekair.com
+1.877.850.4244 / +1.303.682.3168
sales@emtekglobal.com
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Summary of Contents for Emtek P100

  • Page 1 P100 & P100ss Portable Microbial Air Samplers Users Manual Contact Us for Customer Service and Technical Support EMTEK, LLC  1500 Kansas Ave., Suite 4-C Longmont, CO 80501 Website: http://www.emtekair.com Phone: +1.877.850.4244 / +1.303.682.3168 Email: sales@emtekglobal.com P100 USERS MANUAL / FW 2.014 / DEC.2024.V03...
  • Page 2 Section 7 Operating Instructions ........................24 Touch Screen Description and Function ..............24 7.1.1 Setup Screen (Main Menu) ................25 7.1.2 Run Display………………………………………………………………...26 7.1.3 Set Sample Parameters ................. 27 7.1.4 Printer ......................29 P100 USERS MANUAL / FW 2.014 / DEC.2024.V03...
  • Page 3 7.1.13 Save (Sample) Programs (Select, Add, Delete) ..........46 IR Remote Control ..................... 48 7.3.1 Loading the Batteries into the Remote Control ..........48 7.3.2 Operating the P100/P100ss with the Remote Control ........49 Alarms/ Warning Screens ................... 50 Optional Thermal Printer Operation ................51 HEPA Filter &...
  • Page 4 Internal (with User Volume Control) Alarms Flow Alarm +5% (On/Off) P100: 7.5 x 5.5 x 6 inches (19.0 x 13.4 x x 15.3 cm) / P100ss: 7 x 5.375 x 5.5 inches (17.8 x 13.7 x 14 cm) Dimensions Enclosure Materials...
  • Page 5 © 2024 by EMTEK, LLC. All rights reserved. Disclaimer It is the policy of EMTEK, LLC to improve this manual and the products it describes as new technology, components, software, and firmware become available. EMTEK, LLC reserves the right to make changes to any products herein at any time without notice.
  • Page 6 The P100 operates with separate sieve impaction inlet covers for each of the two flow rates, 28.3 LPM (1 CFM) and 100 LPM. The inlet covers include a 300 hole pattern with appropriate inlet hole sizing for each flow rate to assure optimal physical and biological recovery capabilities.
  • Page 7 99,999 samples. The run data cannot be altered within the CPU system of the P100/P100ss. It may only be output (via USB Drive, Printer, or PC), viewed (via LCD, or PC), or cleared from the system.
  • Page 8 1. Débranchez toutes les sources d'alimentation avant d'intervenir sur le P100/P100ss 2. Ne démontez pas l'échantillonneur P100/P100ss pour tenter de le réparer. 3. Contacter EMTEK, LLC ou autres membres du personnel d'entretien qualifié en cas de dysfonctionnement de l'appareil. 4. Ne pas immerger l'échantillonneur P100/P100ss dans un liquide 2.6.1 Referenced hazard information...
  • Page 9 Producer for disposal at no charge to the user. Note: For return for recycling, please contact the equipment producer or supplier for instructions on how to return end-of-life equipment, producer-supplied electrical accessories, and all auxiliary items for proper disposal. P100 USERS MANUAL / FW 2.014 / DEC.2024.V03...
  • Page 10 être prises pour prévenir les dommages aux équipements. English This symbol indicates that a risk of electrical shock and/or electrocution exists. Français Ce symbole signifie qu'il existe un risque de choc électrique et/ou d'électrocution existe. P100 USERS MANUAL / FW 2.014 / DEC.2024.V03...
  • Page 11 PDF output file cannot be altered once generated. EMTEK, LLC does not provide software utilities to comply with the requirements of 21 CFR Part 11 after the data is transferred from a P100/P100ss sampler as a .CSV file to an external source. Users that are subject to FDA regulations are responsible for maintaining compliance with 21 CFR Part 11 after the data is transferred from the P100/P100ss to an external source.
  • Page 12 Section 3 Product Introduction The P100/P100ss is a state-of-the-art Portable Microbial Air Sampler for use with the EMTEK, LLC line of microbial sampling devices. It uses mass flow control to accurately regulate the selected air-flow for precise measurement of the collected volume.
  • Page 13 Remove all items from the carrying case, and/or other shipping container and inspect them for damage. Make sure that all of the items listed are included (Fig 3.2.1), dependent upon purchase options. If any of the items not marked (optional) are missing or damaged, contact your distributor, or EMTEK (sales@emtekglobal.com). 3.2.1 Instrument Component Checklist –P100/P100ss Complete Package Components...
  • Page 14 Cord (1), Label Rolls (3) Horizontal Flow Inlet (w/3 O-Rings) Compressed Air/Gas Sampling Kit (100 LPM): 100 LPM Microbial HPD (316SS Electropolished), P100 Inlet Adapter (w/3 O-Rings), HEPA Exhaust Filters (2), Sanitary Clamp/Gasket (304SS/PTFE), ½ ID Tubing (30”) Fig. 1a-Inlet Cover (AA) Fig.
  • Page 15 Component Carry Case General Description The P100/P100ss comes packaged in a customer carrying case (Fig. 1). The case has custom cut outs in the insert, which will safely hold for transport, and shipping. The insert will hold all of the standard P100/P100ss components, as well as one set of optional accessories.
  • Page 16 2) The P100/P100ss power cord, for the P100/P100ss power supply/charger, should be placed in the P100/P100ss Charger opening, and then the power supply/charger block, as shown in the images to the right of the case.
  • Page 17 Important Note: To minimize hazards and ESD risks, maintenance procedures not requiring power to the P100/P100ss should be performed with power removed. Delicate internal electronic components can be damaged by static electricity, resulting in degraded instrument performance or eventual failure.
  • Page 18 To discharge static electricity from the body and keep it discharged, wear a wrist strap connected by a wire to earth ground. • Handle all static-sensitive components in a static-safe area. If possible, use anti-static floor pads and work bench pads. P100 USERS MANUAL / FW 2.014 / DEC.2024.V03...
  • Page 19 Attach DC Power Input Plug If the P100/P100ss is powered on the Green LED in the upper left corner of the LCD window frame will blink when the unit is charging. You can check the charged status of the unit, by viewing the battery life percentage indicator during the charge cycle.
  • Page 20 DC Input Port: AC/DC Power Supply (Battery Charging, Power Connected Operation) USB Port (W/Port Protection Plug): Data Output to USB drive, firmware updates Ethernet Port (W/Protection Cap): Calibration, Optional Printer Connection, Remote PC Operations P100 USERS MANUAL / FW 2.014 / DEC.2024.V03...
  • Page 21 6. Unit Power On/Off 7. Enclosure (316SS on P100ss, KYDEX Cover with MICROBAN on P100) 8. IR Remote Receiving Sensor 9. USB Port (w/Port Protection Plug): Data Output to USB drive, firmware updates P100 USERS MANUAL / FW 2.014 / DEC.2024.V03...
  • Page 22 Cover with MICROBAN on P100) Transport Handle Ethernet Port (P100ss w/Protective Threaded Cap, or P100 w/Port Plug): For Calibration, Optional Printer Connection, Remote PC Operations DC Input Port: AC/DC Power Supply (Battery Charging, Power Connected Operation) P100 USERS MANUAL / FW 2.014 / DEC.2024.V03...
  • Page 23 Section 6 Quick Start Guide If you are already familiar with the P100/P100ss air sampler, follow these steps to get your P100 or P100ss running: Turn the P100/P100ss power on using the On/Off power button on the right side of the unit. (Fig 5.1.1, NOTE: If the unit is not charged, plug the primary AC/DC power adapter cable into the power receptacle on the rear of the P100/P100ss (Fig 5.2.1, #8), and then attach to an appropriate AC power supply source...
  • Page 24 Selecting “”or“” arrows, brings up the previous, or next keypad views. NOTE: If the touchscreen does not appear to be tracking properly, please follow the Touchscreen Calibration procedure described in section 7.6 P100 USERS MANUAL / FW 2.014 / DEC.2024.V03...
  • Page 25 UNIT INFO Unit Serial Number, Equipment Number, Firmware Version SAVE PRGM Save specific sampling programs, which include: Sample Flow Rate, selected or Set Volume, Delay/Test/Hold periods, Units for Flow and Volume P100 USERS MANUAL / FW 2.014 / DEC.2024.V03...
  • Page 26 START SAMPLE RUN key.    = Start Sample Run, KEYS: = Stop Sample Run, =Pause Sample Run  = Resume Sample Run , =Go to SETUP Screen P100 USERS MANUAL / FW 2.014 / DEC.2024.V03...
  • Page 27 Maximum Volume Allowed: @ 28.3 = 3396 L, @ 100 LPM = 3000 L, or 3 Cubic Meters VOLUME: Can be entered in 1, 2, 3, or 4 characters, from left to right. Example: 1_ _ _ , 10_ _, 100_, or 1000 liters. P100 USERS MANUAL / FW 2.014 / DEC.2024.V03...
  • Page 28 FLOW UNITS = Pick from LOV: Liters Per Minute (LPM), or Cubic Feet/Minute (CFM) Line 6: VOL UNITS = Pick from LOV: Liters, Cubic Meters, or Cubic Feet (shown as L, CM, or CF on Run/Display Screen) P100 USERS MANUAL / FW 2.014 / DEC.2024.V03...
  • Page 29 SET IR CHANNEL= Set the IR remote channel 1-5, default of 1 (See section 7.3 for IR Remote operation) Line 3: Turn flow alarm ON or OFF. Flow alarm is a fixed +-5% set flow. P100 USERS MANUAL / FW 2.014 / DEC.2024.V03...
  • Page 30 To quickly ZERO out the time (00:00:00) for each parameter, simply select a single numeric character in the first entry field and hit return. This will ZERO out the time for that parameter. P100 USERS MANUAL / FW 2.014 / DEC.2024.V03...
  • Page 31 16 Characters to fit screen views. SITE ID Keypad Views/Entry NOTE: Create site names by using the available characters on the keypads. Hit return to save the site ID, or program, on the list of values. P100 USERS MANUAL / FW 2.014 / DEC.2024.V03...
  • Page 32 12-Hour Time Base Example: For a time of 6:15pm, enter: 06:15:00, then “1” (for PM), for 6:15am, enter 06:15:00, then “0” (for AM) 24-Hour Time Base Example: For a time of 6:15pm, enter 18:15:00, for 6:15am, enter 06:15:00 P100 USERS MANUAL / FW 2.014 / DEC.2024.V03...
  • Page 33 3) After a minimum of 7 FULL DAYS (i.e., 168 hours or a full 604,800 seconds), if a drift is noted from the RTS originally used, reset the time, again as accurately as possible based on the RTS. 4) The correction required for the RTC circuit of the P100/P100ss will be calculated and will compensate for the drift going forward.
  • Page 34 General: DATA STORAGE The P100/P100ss CPU will store up to 500 samples in its’ internal memory. A warning will occur at power up, which requires acknowledgement, when memory hits 450 samples. The CPU will delete oldest sample runs to add new ones once 500 samples has been stored in the memory or will prevent new runs from being taken once 500 runs have been stored.
  • Page 35 Select YES on the Confirmation window. The number of samples being printed will be briefly shown. EX: “1..2..3..4..5 of 5”. Once the data output is complete, you will be returned to the main DATA screen view. P100 USERS MANUAL / FW 2.014 / DEC.2024.V03...
  • Page 36 IMPORTANT NOTE: The sample run data cannot be modified and then saved in the P100/P100ss CPU memory. It may only be deleted. The .PDF file output is encrypted (locked) and may not be modified. Downloaded sample run data in .CSV file format is not controlled data and must be handled by the user in a compliant manner.
  • Page 37 (See details in ADMIN screen view for ADMIN OPTIONS, 7.1.11). The CALIB DUE DATE is entered through the P100/P100ss Calibration Software during the P100/P100ss calibration process and is stored in the unit memory. This is not alterable by a User or Administrator.
  • Page 38 NOTE: This alarm function is controlled by the unit Administrator. It can only be turned OFF if ADMIN OPTION control for the CAL DUE ALM is OFF (requires ADMIN ID and Password). Fig. 7.1.10.1 Fig. 7.1.10.2 P100 USERS MANUAL / FW 2.014 / DEC.2024.V03...
  • Page 39 ADMIN ID = EMTEK ADMIN PASSWORD = 12345_ NOTE IMPORTANTE: Chaque P100 est livré avec un compte admin temporaire initial. Ce compte permettra la création d'un compte d'administrateur par le client. Ce compte doit être supprimé une fois un nouveau compte administrateur a été...
  • Page 40 Line 3: Del Admin = Delete the currently viewed ADMIN:. Example as Above: EMTEK Selecting this option brings up the following confirmation screen. Select “YES” or “NO”...
  • Page 41 Line 3: Del User = Delete the currently viewed USER:. Example as Above: EMTEK Selecting this option brings up the following confirmation screen. Select “YES” or “NO”...
  • Page 42 CLEAR DATA: Controls whether or not the user can clear stored data (OFF=User, ON=Admin Only). DATA STORAGE: The P100/P100ss will store up to 500 samples in its internal memory. A warning will occur at power up, which requires acknowledgement, when memory hits 450 samples.
  • Page 43 USER PASSWORD entry screen. Once entered, the USER may then operate the P100/P100ss as normal, within the operations allowed, as set through ADMIN Options. The USER is logged out by powering off the P100/P100ss. If this option is set to OFF, the unit will be useable at Power Up.
  • Page 44 1, or 2 characters (e.g., 198.195.001.015 = 198.195.1.15). NOTE: Once the options are set as desired, the P100/P100ss must be power cycled (Turned OFF then ON) to log out the ADMIN and lock these functions as set, otherwise they can still be modified (turned ON or OFF) by the user.
  • Page 45 Unit Information Screen Options (view only) Firmware 2.00 (and later) View Line 1: SERIAL NO. = Unit Serial number (5 Characters, assigned by EMTEK) Line 2: EQUIP NO = Unit equipment number, if desired. (can be assigned by/for end user during...
  • Page 46 NOTE: Create Program names by using the available characters on the keypads. Hit return to save the new program on the list of values. EXAMPLE PROGRAM: Name: IS08, Flow Rate: 100, Volume: 1000, Delay: 00:00:15, Units: Flow in LPM, Volume in L P100 USERS MANUAL / FW 2.014 / DEC.2024.V03...
  • Page 47 DELETE PROGRAM: Delete the currently shown program under SAVED PROGRAMS. The following confirmation window will appear. Select “YES” or “NO” to delete or retain the program. NOTE: Assure that a “blank” program is retained, or created for ad hoc entries. P100 USERS MANUAL / FW 2.014 / DEC.2024.V03...
  • Page 48 Loading the Batteries into the Remote Control 1. Remove the battery cover. 2. Insert two AAA batteries. Ensure that the poles (+ and -) are correctly positioned. 3. Replace the battery cover. P100 USERS MANUAL / FW 2.014 / DEC.2024.V03...
  • Page 49 7.2.2 Operating the P100/P100ss with the Remote Control 1. Set the IR Channel on the P100/P100ss (under ALARM RMT) to the desired ID (1-5). (See Section 7.1.5) 2. To start the sampling period, press the Start key of the unit to be operated (1-5).
  • Page 50 LOW BATTERY WARNING This alarm may not be turned “ON” or “OFF”. When the battery voltage of the P100/P100ss gets down to a set level during a sample run (13.5 V), the LOW BATTERY warning screen appears, the run is paused and the user is prompted to “ATTACH CHARGER TO CONTINUE”. If a power supply is attached within 60 seconds, the blower will restart and continue the sample.
  • Page 51 7.4.1 Loading Printer Paper/Labels The P100/P100ss may be used with an optional thermal printer. The printer has the option for normal thermal paper operation or can be utilized with specified thermal labels. Important Note: To prevent damage to the print head, the printer should never be operated without paper/labels.
  • Page 52 NOTE: Select and use the “LABEL” setting for “ROLL TYPE” in the P100/P100ss Printer Settings. 6b. If paper, or label stock without backing is used, no specific label alignment is required.
  • Page 53 Attach Ethernet Plug End to P100/P100SS Ethernet Port Attach RJ11 Connector End to P100 Printer Port & Pull Cable into Cable Pass Through Slot NOTE: The printer batteries have to be partially charged to be able to run the unit while charging, if desired.
  • Page 54 2) Power on the P100/P100ss 3) Fully discharge the P100/P100ss. This is best achieved by entering a sample volume of “0”, and a flow rate of 100 LPM, if the 100 LPM inlet is available. This will run the battery down, without multiple interactions by the user.
  • Page 55 Use the handle to transport between sampling locations, or facilities. transporting the P100/P100ss outside of a controlled environment, it is ideal to use the Inlet Cover Lid in place and place the P100 within a clean or sterile transport bag, or supplied custom carrying case, to minimize potential contamination.
  • Page 56 The P100/P100ss is equipped with an Ethernet 10Base-T/100Base-T Port that will allow for optional PC based software programs to view or extract the Sample Run Data and/or operate the P100/P100ss units connected to a Local Area Network (LAN). The Sample Run Data can be downloaded or viewed but cannot be modified while within the units memory. Contact EMTEK, LLC for more information regarding the P100/P100ss Sample Run Data and PDF Report Export Software and/or the Network Control Center Software programs.
  • Page 57 The required plate height is set with the aid of the adjustable stage and media distance indicator on the inside top of the inlet lid. The required sample volume or time period is set on the P100/P100ss set up screen and the testing period is initiated.
  • Page 58 Materials  EMTEK P100/P100ss Air Sampler Calibrated for operation at 28.3 LPM (1 CFM), or 100 LPM with applicable inlet cover. 100 LPM Inlet Cover – Blue Anodized 28.3 LPM (1CFM) Inlet Cover – Clear Anodized 28.3 or 100 LPM 316SS Inlet Cover NOTE: If remote exhaust tubing will be used with the unit, it is ideal that the unit is calibrated with the exhaust tubing in place.
  • Page 59 AC / DC n'est pas branché au cours de désinfection. Ne pas retirer les panneaux ou le capot de la P100/P100ss pour tenter une réparation. Contacter EMTEK, LLC ou autres membres du personnel d'entretien qualifié en cas de dysfonctionnement de l'appareil.
  • Page 60 Perform the sanitization procedure in Appendix B.  The P100/P100ss must be calibrated as a system with the desired configuration (28.3 LPM (1CFM) or 100 LPM inlet cover). Both the 28.3 LPM and 100 LPM can be calibrated on each unit.
  • Page 61 1.4.4.1 With the inlet lid in place and no media on the stage, start the P100/P100ss and run the P100/P100ss for 1-2 minutes (see Section 7).
  • Page 62 Ending the Testing Period: 1.7.1 When the required volume is attained the blower motor automatically shuts off. If desired the test period can be terminated by pressing the Stop key on the P100/P100ss, or on the IR remote. 1.7.2 If desired, the test period can be Pause/Resume by pressing the Pause/Resume key on the P100/P100ss or IR remote control at any time during the testing period.
  • Page 63 Remove the test plate, with the lid in place (Fig A), from the base plate holder and replace the P100 inlet cover (Fig B). Fig A Fig B 1.8.3 Secure the test plate lid to the test plate with tape. P100 USERS MANUAL / FW 2.014 / DEC.2024.V03...
  • Page 64 If additional samples are to be taken at different locations in the same area on the same day, move the P100/P100ss sampler to the next location and repeat applicable portions of this procedure. If the unit is to be used in a different area on the same day (i.e., moved from one classified area to another) it is suggested to repeat applicable sanitization procedures in the next area prior to monitoring.
  • Page 65  P100/P100ss Horizontal Inlet (Optional) 3. A P100 Inlet Cover Lid or other cover (e.g., sanitary cap, or bioshield) may be placed over the sample Inlet of the P100/P100ss during transport and storage to minimize the potential of contamination. 4. Store the P100/P100ss and associated components in a clean and dry place.
  • Page 66 AFIN DE RÉDUIRE LES RISQUES DE CHOC ÉLECTRIQUE débrancher le P100/P100ss Cordon d'alimentation AC / DC, et l'appareil hors tension pendant la désinfection DANGER: NE PAS immerger le contrôleur de P100/P100ss Air Samplre dans tous les liquides! P100 USERS MANUAL / FW 2.014 / DEC.2024.V03...
  • Page 67 2. P100/P100ss Sanitization: 2.1 Before sanitizing the P100/P100ss, insert the supplied Blower Inlet Plug (Fig. 1), USB Port Plug (P100 - Fig. 3) and Ethernet (RJ45) Port Plug (P100 - Fig. 3a), or RJ45 Port Threaded Cap (P100ss – Fig. 3b), into/onto the...
  • Page 68 2.2 Sanitize the exterior of the P100/P100ss, power supply and associated cables (if applicable), and IR Remote (if applicable), with a wipe saturated with disinfectant. It is ideal to wipe the components with a primary disinfectant (Quaternary Ammonium) followed by a secondary disinfectant (70% IPA, or Ethanol).
  • Page 69 Next, saturate a wipe with a sterile secondary disinfectant (e.g., 70% alcohol) and wipe all surfaces of the inlet cover, inlet base, and media stage. Allow for the appropriate contact time and allow to dry. Remove the receptacle plugs, if applicable (ie., Blower Inlet, Ethernet, and USB port plugs). P100 USERS MANUAL / FW 2.014 / DEC.2024.V03...
  • Page 70  Remote Exhaust Kit (C.4) Compressed Air/Gas Sampling Kit The P100/P100ss may be used for Compressed Air/Gas system testing. This can be performed with the following components, supplied with the kit: EMTEK MICRO HPD (High pressure diffuser) A – Exhaust Filters B –...
  • Page 71 Using pre sanitized, or sterilized components, as described above, 1) Attach the inlet adapter (1) to the P100/P100ss pre sanitized or sterilized P100/P100ss inlet cover. Press the inlet Adapter down firmly and evenly, from the top of the inlet, until it seats with the P100/P100ss inlet cover.
  • Page 72 O-ring evenly sitting at the rim of the opening. 6) Press the inlet down firmly and evenly, from the top of the inlet, until it seats with the P100/P100ss inlet cover. 7) Sanitize again if desired, purge the assembly for 30-60 seconds, and then perform sampling per Appendix A, General Sampling with the P100/P100ss.
  • Page 73 The supplied tubing may be autoclaved as well. For use: 1) Simply set the inlet adapter on top of a sanitized P100/P100ss 100 LPM, or 28.3 LPM inlet cover, with the O-ring evenly sitting at the rim of the opening in the inlet cover.
  • Page 74 For use: 1) Simply thread the exhaust adapter into the exhaust port on the P100/P100ss. This should be finger tight only. Tools shoot not be used, or needed, to attach, or detach the fitting. Note, the nut, retaining the tubing, can be threaded off first, and the male/male fitting can be attached to the exhaust port, and then the exhaust tubing/nut assembly can be threaded into the P100/P100ss adapter fitting.
  • Page 75 Microbial Identification. Discard all other plates in an appropriate Bio-Hazard container for disposal. Test Report Forms, once completed, should be reviewed for accuracy and completeness, and signed by a second qualified analyst. P100 USERS MANUAL / FW 2.014 / DEC.2024.V03...
  • Page 76 P100 USERS MANUAL / FW 2.014 / DEC.2024.V03...
  • Page 77 Appendix 1: CE Declaration of Conformity P100 USERS MANUAL / FW 2.014 / DEC.2024.V03...
  • Page 78 Appendix 2: Two Year Warranty P100 USERS MANUAL / FW 2.014 / DEC.2024.V03...
  • Page 79 Appendix 3: .PDF Data File Export - Sample Run Data Report Example P100 USERS MANUAL / FW 2.014 / DEC.2024.V03...
  • Page 80 Appendix 4: .CSV Data File Export - Sample Run Data Output Example Note: Opened and Formatted in MS Excel P100 USERS MANUAL / FW 2.014 / DEC.2024.V03...

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