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Emtek R100 User Manual

Remote microbial air sampler
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R100 Remote Microbial Air Sampler
EMTEK, LLC - R100 USERS MANUAL / AUG2019.REV01
User's Manual
Contact Us for Customer Service and Technical Support
1500 Kansas Ave. Suite 4-C
Longmont, CO 80501
Website:
Phone:
Email:
Fax:
EMTEK, LLC
http://www.emtekair.com
+1.877.850.4244 / +1.303.682.3168
sales@emtekglobal.com
303.223.2804
1

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  • Page 1 R100 Remote Microbial Air Sampler User’s 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 Fax: 303.223.2804 EMTEK, LLC - R100 USERS MANUAL / AUG2019.REV01...

  • Page 2: Table Of Contents

    Touch Screen Description and Function ..............23 7.1.1 Setup Screen (Main Menu) ................24 7.1.2 Run Display..................……25 7.1.3 Set Sample Parameters ................. 26 7.1.4 Printer ......................28 7.1.5 Alarm (Flow) & IR Remote Settings ............. 28 EMTEK, LLC - R100 USERS MANUAL / AUG2019.REV01...
  • Page 3 7.1.13 Save (Sample) Programs (Select, Add, Delete) ..........41 IR Remote Control ..................... 43 7.2.1 Loading the Batteries into the Remote Control ..........43 7.2.2 Operating the R100 with the Remote Control ..........44 Alarms/ Warning Screens ................... 45 Optional Thermal Printer Operation ................46 HEPA Filter Replacement ...................

  • Page 4: Specifications

    Section 1 Specifications R100 Air Sampler Controller & Remote Air Sampler (RAS) Motor Type Blower Motor Display/Interface Two Color LCD with Touch Screen (Blue on White), CPU Current Firmware Version 1.097 (or later versions, until otherwise revised) Sample Time/Volume Variable (User Defined), Maximums: 120-minutes/3396 Liters* @ 28.3 LPM, 30-min/3000L @ 100 LPM...

  • Page 5: General Information

    © 2019 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: R100 Technical Description

    100 LPM. The highest flow rate, 100 LPM, allows for the collection of a cubic meter of air in 10-minutes, while the 28.3 LPM (1 CFM) flow rate takes approximately 35 minutes to capture a cubic meter. At the 100LPM flow rate the R100 is capable of sampling with a maximum tubing length of 10 feet (3 meters), while at the 28.3LPM flow rate the R100 is capable of...
  • Page 7 R100 IR Receiver window located just above the touch screen display on the R100. The supplied single IR remote can operate up to 5 R100’s with different IR ID#’s set on the unit (user selectable IR ID#’s 1 through There are several options available for the R100.

  • Page 8: Safety Notices

    2. Do not disassemble the R100 controller to attempt any repairs. 3. Contact EMTEK, LLC or other qualified service personnel if the unit malfunctions. 4. Do not submerse the R100 controller or any sampler in any liquid. Français DANGER: un choc électrique ou des dangers d'électrocution 1.

  • Page 9: 2.6.2 Precautionary Labels

    Remarque: Pour le retour pour recyclage, s'il vous plaît contacter le producteur ou le fournisseur du matériel pour obtenir des instructions sur la façon de revenir en fin de vie des équipements, producteurs-fournis accessoires électriques, et tous les éléments auxiliaires pour une élimination appropriée. EMTEK, LLC - R100 USERS MANUAL / AUG2019.REV01...
  • 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. EMTEK, LLC - R100 USERS MANUAL / AUG2019.REV01...

  • Page 11: Standards And Regulation

    EMTEK, LLC does not provide software utilities to comply with the requirements of 21 CFR Part 11 after the data is transferred from a R100 controller 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 R100 to an external source.

  • Page 12: Section 3 Product Introduction

    Section 3 Product Introduction The R100 is a state-of-the-art Microbial Air Sampler controller 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 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). Instrument Component Checklist – Standard R100 Package Components 3.2.1...
  • Page 14 PORT PLUG: The supplied threaded plug shown is included with the RAS, and can be removed and used as desired to plug the unused connector port (Plug shown in bottom connector port). EMTEK, LLC - R100 USERS MANUAL / AUG2019.REV01...

  • Page 15: Optional Accessories

    (w/3 O-Rings) Remote Exhaust Kit (w/5 Feet of Tubing) Additional RAS Sampler Remote Sampling Adpater (Comes with or w/o tubing) Inlet Cover Lid NOTE: See Appendix C for description/use of R100 Optional Components EMTEK, LLC - R100 USERS MANUAL / AUG2019.REV01...

  • Page 16: Component Packaging

    Component Packaging General Description The R100 comes packaged in an a custom foam box insert (Fig. 1). The foam has custom cut outs for the included components, R100 Controller, RAS, as well as some additional accessories, which will safely hold for transport, and shipping. If numerous optional accessories are ordered, the additional components may be delivered in an oversized box, along with the R100 Package, or a separate extra box, if they do not all fit in one package.

  • Page 17: Section 4 Installation

    Note Importante: Pour minimiser les dangers et les risques de l'EDD, les procédures d'entretien non nécessitant une alimentation à la R100 devrait être exécuté avec la puissance retirés. Interne sensible composants électroniques, peuvent être endommagés par l'électricité statique, résultant en instrument une dégradation des performances ou de l'échec éventuel.
  • 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. EMTEK, LLC - R100 USERS MANUAL / AUG2019.REV01...

  • Page 19: Electrical/Data Connections

    R100 Side View Connections: DC Input Port: AC/DC Power Supply (Power Connected Operation) USB Port: Data Output to USB stick, firmware updates Ethernet Port: Calibration, Optional Printer Connection, Remote PC Operations Power On/Off Button EMTEK, LLC - R100 USERS MANUAL / AUG2019.REV01...

  • Page 20: R100 Description

    1. RAS Inlet Cover (100 LPM in 316SS Shown) 2. RAS Remote Base (316SS Shown) 3. Unit Power ON Indicator Green LED (Power On=Solid, Sample Run=Flashing) 4. IR Remote Receiving Sensor 5. LCD/ Touchscreen Interface 6. 316 Stainless Steel Enclosure EMTEK, LLC - R100 USERS MANUAL / AUG2019.REV01...

  • Page 21: R100 Rear View

    Sanitary Clamp for R100, or RAS 316 SS Sanitary Tubing Connector for R100, or RAS Sanitary Seals 316 SS Sanitary Tubing Connector (Barb for RAS, or R100 Sanitary Clamp for RAS, or R100 RAS 316 SS Sanitary Connector RAS Sampler R100 Controller EMTEK, LLC - R100 USERS MANUAL / AUG2019.REV01...

  • Page 22: Quick Start Guide

    If the R100 is plugged in to its’ power supply, press the ON/OFF power button on the right side of the unit (Fig 4.3.1, #4). If not plugged in, plug the primary AC/DC power adapter cable into the power receptacle on the right side of the R100, and then attach to an appropriate AC power supply source that is 100-240 VAC, and 50/60 Hz.

  • Page 23: Operating Instructions

    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 EMTEK, LLC - R100 USERS MANUAL / AUG2019.REV01...

  • Page 24: Setup Screen (Main Menu)

    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 EMTEK, LLC - R100 USERS MANUAL / AUG2019.REV01...

  • Page 25: Run Display

    START SAMPLE RUN key. ◼  KEYS: = Start Sample Run, = Stop Sample Run, =Pause Sample Run  = Resume Sample Run , =Go to SETUP Screen EMTEK, LLC - R100 USERS MANUAL / AUG2019.REV01...

  • Page 26: Set Sample Parameters

    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. EMTEK, LLC - R100 USERS MANUAL / AUG2019.REV01...
  • Page 27 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) EMTEK, LLC - R100 USERS MANUAL / AUG2019.REV01...

  • Page 28: Printer

    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. EMTEK, LLC - R100 USERS MANUAL / AUG2019.REV01...

  • Page 29: Delay, Test, & Hold Settings

    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. EMTEK, LLC - R100 USERS MANUAL / AUG2019.REV01...

  • Page 30: Site Descriptions

    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. EMTEK, LLC - R100 USERS MANUAL / AUG2019.REV01...

  • Page 31: Date & Time Settings

    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 EMTEK, LLC - R100 USERS MANUAL / AUG2019.REV01...

  • Page 32: Data Output (Printer & Usb)

    General: DATA STORAGE The R100 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 33 Microsoft Excel. IMPORTANT NOTE: The data cannot be modified and then saved on the R100 unit. Once the data is saved outside of the R100 system, the data integrity is not guaranteed by EMTEK. EMTEK. LLC does not provide external software that is 21 CFR Part 11 compliant.

  • Page 34: Calibration (Due & Notification)

    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. 7.10.1.1 Fig. 7.10.1.2 EMTEK, LLC - R100 USERS MANUAL / AUG2019.REV01...

  • Page 35: Administrative (Admin & User)

    ADMIN ID = EMTEK ADMIN PASSWORD = 12345_ NOTE IMPORTANTE: Chaque R100 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 établi. Le compte provisoire est le suivant:...
  • Page 36 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 37 Enter desired USER PASSWORD, of 3-5 NUMERIC characters, through the keypad, then press the return key to save, and/or exit the keypad screens. 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 38: Administrative Control Options

    NOTE: Once the options are set as desired, the R100 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 39 Line 2: CONTRAST: Adjust character contrast to general screen brightness. Line 3: BUZZER: ON/OFF selection for Keypad “Beeps”, Flow Alarm, End of Run Alarm Line 4: VOLUME: Adjust volume of Alarm, Buzzer, Beeps (scaled 1-20). EMTEK, LLC - R100 USERS MANUAL / AUG2019.REV01...

  • Page 40: Unit Information (Firmware Version)

    Unit Information Screen Options (view only) Firmware 1.092 (and later) View Line 1: SERIAL NO. = Unit Serial number (5 Characters, assigned by EMTEK) Line 2: EQUIP NO = Unit equipment number, if desired. (assigned by end user during calibration) Line 3: FIRMWARE = Current Firmware Version of unit (ex: 1.097)

  • Page 41: Save (Sample) Programs (Select, Add, Delete)

    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 EMTEK, LLC - R100 USERS MANUAL / AUG2019.REV01...
  • Page 42 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. EMTEK, LLC - R100 USERS MANUAL / AUG2019.REV01...

  • Page 43: Ir Remote Control

    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. EMTEK, LLC - R100 USERS MANUAL / AUG2019.REV01...

  • Page 44: Operating The R100 With The Remote Control

    7.2.2 Operating the R100 with the Remote Control 1. Set the IR Channel on the R100 (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 45: Alarms/ Warning Screens

    “normal” voltage requirement required, the blower will shut down. The unit may be restarted, but the reason for the event should be investigated, and remediated, if possible. EMTEK, LLC - R100 USERS MANUAL / AUG2019.REV01...

  • Page 46: Optional Thermal Printer Operation

    7.4.1 Loading Printer Paper/Labels The R100 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 47 NOTE: Select and use the “LABEL” setting for “ROLL TYPE” in the R100 Printer Settings. 6b. If paper, or label stock without backing is used, no specific label alignment is required.
  • Page 48 Attaching the Ethernet-to-RJ11 Communication Cable Between R100 & Printer Attach Ethernet Plug End to R100 Ethernet Port Attach RJ11 Connector End to P100 Printer Port & Pull Cable into Cable Pass Through Slot NOTE: The printer batteries must be partially charged to be able to run the unit while charging, if desired.

  • Page 49: Hepa Filter Replacement

    Seuls les techniciens de maintenance certifié doit effectuer un remplacement du filtre. HEPA FILTER: The R100 is equipped with a HEPA filter exhaust. It is recommended to replace the HEPA filter every 12-36 months as part of periodic maintenance. EMTEK, LLC - R100 USERS MANUAL / AUG2019.REV01...

  • Page 50: Touch Screen Sensor Calibration

    Touch Screen Sensor Calibration The touch screen on the R100 is equipped with a calibration program. To perform the calibration, hold down the unit primary power button for approximately 6 seconds. The touch screen calibration screen should appear. Immediately release the power button at that point. The screen will show the first calibration point at the upper left hand side of the screen.

  • Page 51: Network Operation Of The R100

    The R100 is equipped with an Ethernet 10Base-T/100Base-T Port that will allow for the P100 PC CONTROL SOFTWARE program to view or extract the Sample Run Data (Run Data), and/or operate the R100 units connected to the Ethernet. The Sample Run Data can be downloaded or viewed but cannot be modified while within the unit’s memory. See the P100 PC CONTROL SOFTWARE Procedure included on the USB drive that shipped with the R100 Package.

  • Page 52: Appendix A R100 Sampler - General Sampling Procedure

    An additional option allows for attachment of remote exhaust tubing to move the exhaust well away from the test location. Upon completion of the test period, the test plate is removed from the R100 RAS and is incubated for a designated time period at a specified temperature.

  • Page 53: Materials

    EMTEK R100 Air Sampler, RAS, and power supply, Calibrated for operation at 28.3 LPM (1 CFM), or 100 LPM with applicable inlet cover. NOTE: If remote exhaust tubing will be used with the R100, it is ideal that the unit is calibrated with the exhaust tubing in place.

  • Page 54: R100 Sampler Assembly Set-Up And Testing

    Ne pas retirer les panneaux ou le capot de la R100 pour tenter une réparation. Contacter EMTEK, LLC ou autres membres du personnel d'entretien qualifié en cas de dysfonctionnement de l'appareil. Ne plonger le R100 dans les liquides! Utiliser des bouchons de protection fourni pour Ethernet, USB et ports d'entrée du ventilateur.
  • Page 55 EMTEK. Smaller ID tubing will be too restrictive to achieve the desired flow rate at the RAS. Connect the tubing to the R100 and the RAS using the supplied sanitary connector fittings, seals, and clamps, as shown in the following examples for flexible tubing (Fig 1) and rigid tubing (Fig ).
  • Page 56 Fig 2 -RIGID TUBING (RAS Bottom Connection Port Used) EMTEK, LLC - R100 USERS MANUAL / AUG2019.REV01...
  • Page 57 1.5.1.1 The stage should be lowered or raised to a point that the distance gauge, located on the interior center surface of the R100 RAS inlet cover (FIG B), makes a mark on the center of the surface of a test media plate (FIG C) that looks like FIG D. If the media stage is too high, you will see a mark on the media surface similar to FIG E (media crushed).
  • Page 58 1.5.2.1 With the inlet lid in place and no media on the RAS stage, start the R100 and run the R100 for 1-2 minutes (see Section 7).
  • Page 59 1.8.1 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 R100, or on the IR remote. 1.8.2 If desired, the test period can be Pause/Resume by pressing the Pause/Resume key on the R100 or IR remote control at any time during the testing period.
  • Page 60 Remove the test plate, with the lid in place (Fig A-Fig B), from the base plate holder and replace the RAS inlet cover (Fig C). Fig A Fig B Fig C 1.9.3 Secure the test plate lid to the test plate with tape. EMTEK, LLC - R100 USERS MANUAL / AUG2019.REV01...
  • Page 61 RAS 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. EMTEK, LLC - R100 USERS MANUAL / AUG2019.REV01...

  • Page 62: Storage And Transport

    1. For transport or storage outside of a facility the entire assembly may be placed in a clean or sterile bag, or container, to minimize possible contamination of the unit. Be sure to transport the RAS and R100 separately or with proper protection between them to ensure neither of them come in contact and cause damage to each other.

  • Page 63: Appendix B Suggested R100 Sampler Sanitization

    • Primary Disinfectants (e.g., Quaternary Ammonium Compounds) Important Note: Phenolic disinfectants should not be used on the R100 LCD/Touchscreen overlay, as it will cause the overlay to become very brittle in a short period of time. • Secondary Disinfectants (e.g., 70% 0.2µm filtered or sterilized alcohol, EtOH, or IPA) •...
  • Page 64 Port Plugs 2.2 Sanitize the exterior of the R100, 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 (eg., Quaternary Ammonium) followed by a secondary disinfectant, preferably 70% IPA, or...
  • Page 65 Note : To best protect the electronics of the R100 Controller, it is ideal to have the USB Port Plug always plugged in the port, until the port is required for data acquisition. And, the Ethernet Port Cap should be in place as well, unless the R100 is being operated remotely via ethernet connection.
  • Page 66 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. EMTEK, LLC - R100 USERS MANUAL / AUG2019.REV01...

  • Page 67: Appendix C Optional Sampling Components

    Remote Exhaust Kit (C.2) Horizontal Flow Inlet The R100 may be used for monitoring in a horizontal airflow environment (e.g., LAF Hood, HEPA Wall Filtration Suite, etc.) with the aid of the P100 RAS Horizontal Flow Inlet (P100.HRZINLT), depicted below.

  • Page 68: Remote Exhaust Kit

    For use: 1) Simply thread the exhaust adapter into the exhaust port on the R100. 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 R100 adapter fitting.

  • Page 69: Appendix D Suggested Sample Submission And Results Recording

    Test Report Forms, once completed, should be reviewed for accuracy and completeness, and signed by a second qualified analyst. NOTE: If Feller Calculations are required by your procedures, a Feller table follows. Please use at your discretion. EMTEK, LLC - R100 USERS MANUAL / AUG2019.REV01...

  • Page 70: Feller Calculation Tables

    FELLER CALCULATION TABLE (1-100 CFU) Applies to R100 300 Hole inlet Covers: R100.INLT.28 (28.3 LPM/1 CFM) & R100.INLT.100 (100 LPM) Description 1500 Kansas Ave. Suite 3F, Longmont, CO 80501• TEL (303)682-3168 / FAX (303)223.2804 Feller conversions are calculations performed, per the formula below, to allow for potential coincidence capture events,...

  • Page 71: Appendix E Warranty

    Appendix E: Two Year Warranty EMTEK, LLC - R100 USERS MANUAL / AUG2019.REV01...

  • Page 72: Appendix F Packaging

    -Maintain all Custom Packaging Components for System Shipments- NOTE: Components are not shown as packaged in additional protective clear bags, as they will be packaged and shipped from EMTEK. It is strongly suggested to keep all supplied bags for storage and/or shipment.
  • Page 73 Appendix F: Packaging Components and Packaging (continued) Packaging Insructions: 1) Place R100 and RAS Air Sampler Components in the Component Tray, and tubing in the Spacer pocket, as shown on the previous page. 2) Assemble the packaging contents as shown below, and described in steps A-D A) Place Component Tray Cover on Component Tray and set Carboard Spacer on top of Component tray B) Lay the outer shipping box flat on its’...

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