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EMTEK V100 Product Manual FEB2011

1. NOTE There is no check valve in place to cause back pressure on the system at the completion of the sample period The compressed gas air will continue to flow through the system The diffuser will allow the excess pressure from the compressed air gas system to vent until the air gas supply is turned off 10 7 4 3 10 7 4 4 Note 10 7 4 5 10 7 4 6 Page 45 of 75 EMTEK V100 001v01 FEB2011 Remove the dome assembly retention clip and place on the edge of the blue dome seal Aseptically remove the test plate from the turntable as follows Gloved hands should be rinsed with secondary disinfectant immediately prior to performing these steps 10 7 4 4 1 Remove the dome from the RCG sampler with one hand and with the other hand replace the lid of the test plate being careful not to touch the inside of the lid or the agar surface Do not move your hand over the exposed surface of the test plate Allow the lid to lead your hand over the test plate as you replace it 10 7 4 4 2 Remove the test plate with the lid in place from the turntable and place the dome back on the RCG sampler 10 7 4 4 3 Secure the lid to the test plate with tape Assure all applicable information is recorded on the test plate as required Upon completion of the test period a printout label or Paper tape is generated from the on board thermal printer with the sample parameter information e g Sample Start Stop Time Site Date Oper
2. 1 5 3 Aseptically place the test plate e g 90 mm TSA plate on the turntable as follows NOTE Gloved hands should be cleaned with secondary disinfectant immediately prior to performing these steps 1 5 4 Lift up the dome assembly just high enough to place the test plate on the turntable and remove its lid Without inverting place the lid of the test plate face down on a pre sanitized surface NOTE Removing and holding the dome only a few inches directly over the turntable will minimize the chance of contaminants settling on the sanitized components under the dome and on the test plate during this manipulation 1 5 5 Place the dome assembly down over the test plate and turntable 1 5 6 Securely seat the dome assembly in the dome to base seal and assure that the dome is properly seated in the seal 1 5 7 Replace the dome assembly retention clip 1 5 8 Adjust the Turntable Test Plate Height Adjustment as follows 1 5 8 1 View the test plate distance indicator through the side of the dome to assure that test plate is at the proper height 1 5 8 2 Rotate the turntable adjustment knob clockwise or counter clockwise until the top of the test plate just touches the distance indicator on the interior center of the dome This adjustment will assure the required distance of approximately 2 3 mm from the test plate surface to the opening of the sample slit 1 5 9 Press Start on the V100 or on the remote to initiate the blower motor Page 51
3. The sampled air volume passes through the system and is then exhausted from the V100 located outside of or away from the critical environment or test area through a 0 2 micron HEPA filter Upon completion of the test period the test plate is removed from the RAS and is incubated for a designated time period at a specified temperature Following the required incubation period the number of bacterial Colony Forming Units CFU are enumerated The density of air borne bacteria per volume of air tested can then determined Page 54 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual C 2 Materials e EMTEK RAS Air Sampler and V100 Controller Calibrated for operation at 28 3 50 or 100 LPM with vacuum tubing assembly e Standard 90 mm TSA Agar Test Plates e 30 35 C and or 20 25 C Incubators e Gloves Sterile or Clean e Low Particulate Shedding Wipes e g Wipe All Gamma Wipes or equivalent better e Disinfectants e g Quaternary Amonium Compounds 70 0 2um Filtered or sterilized alcohol e Lab Marker and or Pre Printed Labels e Adhesive Tape C 3 Maintenance Inspection To assure appropriate operation of the RAS sampling assembly prior to each days use sampling personnel should inspect the unit for any obvious physical defect This inspection shall include but not be limited to the following e A visual check of the base seal to a
4. V100 Controller and Air Sampler Users Manual 7 5 Connecting the Samplers Attach the appropriate end of the power supply cable to the connector on the R2S RCG samplers power is not required for the RAS Align the two keys of the cable connector with the key way Firmly press the cable end connector onto the R2S RCG connector while threading the collar clockwise until it becomes finger tight Figs 7 5 2 R2S and 7 5 3 RCG Attach the vacuum supply tubing to the R2S RCG RAS sampler by placing tubing over the barb and pressing firmly to achieve an airtight fit Figs 7 5 1 7 5 2 and 7 5 3 Fig 7 5 1 RAS Vacuum Supply Connection Fig 7 5 2 R2S Power and Vacuum Supply Connection Fig 7 5 3 RCG Power and Vacuum Supply Connection Page 28 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual To connect to the V100 unit attach the end of the power supply cable to the connector on the V100 R2S and RCG Align the two keys of the cable connector with the key way Firmly press the cable end connector into the power connector while threading the collar clockwise until it becomes finger tight Figs 7 5 5 Attach the vacuum supply tubing RAS R2S and RCG to the V100 by placing the tubing into the tube connector and pressing down firmly to achieve an airtight fit Fig 7 5 4 RAS and 7 5 5 R2S RCG SINGLE RAS HEAD OPERATION VACUUM CONNECTIO
5. V100 and primary AC power supply cord 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 English WARNING DO NOT DIRECTLY SPRAY THE V100 with any disinfectants or other liquids Francais ATTENTION NE PAS pulv riser directement Le V100 avec les d sinfectants ou d autres liquides Important Note Spraying the unit would potentially allow the disinfectant to enter into the interior of the case and damage its components causing it to fail Note Importante La pulv risation de l unit permet ventuellement le d sinfectant pour entrer dans l int rieur de l esp ce et les d g ts de ses composants provoquant son chec 3 Air Sampler Sanitization 3 1 Remove the R2S RCG dome assembly from the sampler or RAS top cover 3 2 Sanitize the exterior surfaces of the sampler 1 e the body dome to base seal turntable turntable adjustment knob RAS cover and base exterior RAS base seal etc with a new wipe saturated with secondary disinfectant WARNING Be careful not to saturate the air passageway opening located beneath the R2S RCG turntable or in the RAS base as this would allow the disinfectant to be drawn into the pump and pose an electrical hazard ATTENTION Soyez prudent de ne pas saturer l ouverture de passage d air situ sous le R2S RCG tourne disque ou dans la base de RAS car cela
6. allowing appropriate contact time Wipe off residual disinfectant with a new wipe 3 5 Next saturate a wipe with a sterile secondary disinfectant e g 70 alcohol and wipe all surfaces of the dome assembly and sample chamber Allow for the appropriate contact time and allow to dry 3 7 Following sanitization replace the dome to base seal on the sampler if applicable and then place the dome and sample chamber assembly back on the sampler For the RCG assure that the dome is properly seated in the seal and the spring clip is place For the RAS replace the top cover over the base and base seal 3 8 For the RCG sampler the sanitary sample tubing assembly may be autoclaved before use each day if desired Page 69 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual Appendix F Suggested Sample Submission and Results Recording This section applies to all sampler types 1 Submit the test plate s and test parameter information to in the appropriate lab for recording and further testing 2 Qualified personnel record the required test parameter information on the appropriate electronic or hard copy test report form and place the test plates On Test in incubation 3 Incubate the test plates with an appropriate incubation scheme e g 30 35 C for a minimum of 5 days other incubation requirements or schedules may be used as ap
7. de disposition du public apr s le 12 ao t 2005 En conformit avec les r glementations locales europ ennes et nationales Directive europ enne 2002 96 CE les utilisateurs europ ens d quipements lectriques doivent maintenant retourner vieux ou en fin de vie des quipements au producteur pour l limination sans frais pour l utilisateur Page 9 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 Page 10 of 75 V100 Controller and Air Sampler Users Manual Note Pour le retour pour recyclage s il vous pla t contacter le producteur ou le fournisseur du mat riel pour obtenir des instructions sur la fa on de revenir en fin de vie des quipements producteurs fournis accessoires lectriques et tous les l ments auxiliaires pour une limination appropri e English This is the safety alert symbol Obey all safety messages that follow this symbol to avoid potential injury If on the instrument refer to the instruction manual for operating on or safety information Francais Ceci est le symbole de s curit Respectez tous les messages de s curit qui suivent ce symbole afin d viter d ventuelles blessures Si sur l instrument se reporter au manuel d instructions pour l exploitation ou de l information sur la s curit English This symbol indicated the presence of devices sensitive to Electro static Discharge ESD and indicated that care must be taken to pr
8. may be operated from the controller During testing the sampled air volume drawn through each air sampler is HEPA filtered before being exhausted within the V100 The V100 also supplies power and stepper motor rotational control of the turntable platform of both the R2S and RCG air samplers Based on the set sampling period the turntable and a test plate located on the turntable will rotate a approximately 355 degrees within the defined sampling period This 355 degree rotation creates a none sampled buffer zone on the test plate between the starting point and finishing point This allows for the determination of the time of recovery of bacterial or fungal colony forming units CFU captured during the sampling period based upon the time recorded for the sample period and the location of the CFU on the test plate This determination allows the operator to tie the contamination recovery event with operations that may have occurred at the time of the CFU recovery event Page 6 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual The V100 software allows for sampling periods of up to 240 minutes at the 28 3 LPM sample rate while sample times are limited to 40 minutes at 50 LPM and 20 minutes at 100 LPM EMTEK strongly suggests that all sampling periods employed by be qualified by the user to verify appropriate organismal recovery In addition the V100 offers t
9. 1 4 A cover e g sanitary cap or bio shield may be placed over the sanitary fitting opening of the sample conduit of the RCG dome assembly during transport and storage to minimize contamination Store the V100 and RCG assemblies in a clean and dry place 3 The sanitary sample tubing assembly attaching the RCG to sample location may be autoclaved or chemically sanitized before or after each use Itis ideal to package and store the assembly to minimize the contaminant load Page 53 of 75 Autoclave pouches may be used for this purpose EMTEK V100 001vOI FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual Appendix C Remote Autoclavable Sampler RAS Operation PURPOSE To describe the procedure to monitor for viable airborne bacteria with the Remote Autoclavable Sampler Assembly RAS from EMTEK LLC C 1 RAS Operating Principles A 90 mm agar based test plate is placed on the base plate of the RAS underneath the top cover assembly The required sample time period is set on the V100 controller and the testing period is initiated During testing the vacuum pump of the V100 draws 28 3 50 or 100 SLPM into the RAS sampler s through the sample inlets Airborne bacteria in the sampled volume of air become impinged captured on the test plate The sampled air volume is then drawn through the vacuum line into the vacuum inlet of the V100 and through the controller
10. Components Component Tray bi Tray Cover Foam Manual Cable Tray Tray w Manual amp Cables Page 73 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual Appendix 3 Packaging Components and Packaging continued NOTES e Place V100 and Air Sampler Components Packaging in the EMTEK Shipping box in the following order e Components are not shown as packaged in additional protective clear bags Itis strongly suggested to additionally package components in appropriately size bags for storage and or shipment 1 V100 in Cage 2 Component Tray 3 Component Tray Cover 4 Manual Cable Tray Page 74 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63
11. LLC Versatile 100 is an air sampler controller that operates the EMTEK line of microbial air samplers It is an extremely versatile air sampling system that operates on AC power Its enclosure is comprised of a top cover that is made of Kydex that lies over a 316 Stainless Steel chassis The Kydex cover contains Microban an antimicrobial agent that minimizes and or reduces the growth of microbial contaminants that may come in contact with the Kydex cover The user interfaces with the V100 through a color LCD touch screen for entering user defined sample parameters and for the initiation and termination of sample runs During operation the LCD displays key sample information as well as a visual sample progress indicator The V100 offers three 3 sample flow rates 28 3 50 and 100 Liters Per Minute LPM The highest flow rate 100 LPM allows for the collection of a cubic meter of air in 10 minutes The flow is controlled through a proprietary control system which offers automatic flow control of the three defined flow rates Flow rates are calibrated and set against traceable standards through the use of an external software program and may not be altered through the user interface on the unit Sample rates and total volume sampled maybe displayed and output in Cubic Feet Liters or Cubic Meters Alarm settings are available for the flow rates which will produce both an audible and visual alarm during operation and will then be output
12. Place the RCG at the desired compressed air or gas test site e g on a bench cart table etc within the constraints of the vacuum power cable assembly and sanitary sample tubing e g 2 feet 3 Following the EMTEK 50 LPM Microbial High Pressure Diffuser Procedure to attach the RCG to the sample point In general attach the tubing end of the sanitized or autoclaved sanitary sample tubing to the EMTEK Microbial High Pressure Diffuser which has been attached to the compressed air gas drop using a sanitary clamp assembly Attach the end of the sample tubing with the sanitary fitting to the sanitary fitting on the RCG sample inlet using a sanitary seal and clamp Page 42 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual 4 Ifthe dome assembly has been chemically sanitized assure residual disinfectant and particulate matter from cleaning and set up are removed from the sample chamber and dome assembly by purging the unit prior to attaching the vacuum tubing to the RCG sampler 5 Assure that the dome assembly retention clip is in place and then slowly open the compressed air or gas drop The drop should be regulated to between 15 and 115 PSI This can be accomplished by having the system or drop regulated to the required PSI or by using the EMTEK Microbial High Pressure Diffuser to reduce the sampled flow of the drop Note The dome assembly reten
13. Touch Screen Interface 6 KYDEX Cover with MICROBAN antimicrobial protection Page 18 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual 5 2 V100 Rear View 2 3 4 5 7 6 8 9 Fig 5 2 1 V100 Rear View l Transport Handle 2 Sampler Transport Cup 3 Sampler Vacuum Connection 4 Sampler Electrical Connection 5 Ethernet Port 6 Power Supply Fan 7 Cooling Fan 8 USB Port 9 Power Switch Primary AC Power Inlet Page 19 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual Section6 Quick Start Guide English DANGER Electric shock hazard Always disconnect power to the instrument when making electrical connections Francais DANGER Un choc lectrique risque Toujours couper l alimentation de l instrument lors des branchements lectriques If you are already familiar with the V100 Controller follow these steps to get your controller running l Connect the sampler power cable as applicable and vacuum supply tubing to the V100 Controller Fig 5 2 1 4 and 3 pA Connect the sampler power cable s as applicable and vacuum supply tubing to the R2S RCG or RAS sampler Section 7 5 3 Plug the primary AC power cable into the power supply on the back panel of the V100 Fig 5 2 1 9 and then attach to an appro
14. Without inverting place the lid of the test plate face down on a pre sanitized surface next to the RAS NOTE Removing and holding the top sampling cover only a few inches directly over the base plate holder will minimize the chance of contaminants settling on the sanitized components under the dome and on the test plate during this manipulation 1 5 4 Place the top sampling cover down over the test plate and onto the seal on the base plate holder 1 5 5 Assure that the top sampling cover is properly seated on the seal Page 57 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual 1 6 Starting the Testing Period 1 6 1 Press the Start button on the V100 or remote control to begin the test cycle 1 6 2 If desired the test period can be paused resumed by pressing the pause resume key on the V100 or remote control at any time during the testing period 1 7 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 timer or on the remote 1 7 2 If desired the test period can be Pause Resume by pressing the Pause Resume key on the V100 or remote control at any time during the testing period 1 8 Aseptically remove the test plate as follows NOTE Gloved hands should be rinsed with secondary disinfectant and all
15. are missing or damaged contact the manufacturer A user manual is also shipped with the V100 Air Sampler Controller Fig 3 3 1 Packaged Items Figure 3 3 1 Instrument Components V100 Controller 2 One or more of the following depending on purchase Air Sampler and Dome R2S RCG RAS Sieve Sampler 3 Power Vacuum Supply Cable Tubing R2S and RCG Vacuum Supply Tubing Only for RAS Various lengths depending on purchase V100 Primary AC Power Cord 6ft 5 Optional Additional Dome R2S RCG 28 3 50 100 LPM or Additional RAS Cover RAS 28 3 50 100 LPM 6 IR Remote Control 7 Paper Rolls 2 Label Rolls 2 Not Shown User s Manual NIST Traceable Calibration Reports s NOTE See Appendix 3 for Component Packaging Page 14 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual Section 4 Installation English Danger Only qualified personnel should perform the tasks specified in this section Francais Danger Le personnel seulement qualifi devrait ex cuter les t ches sp cifi es dans cette section 4 1 Wiring safety information Follow all warnings and notes when making wiring connections to the instrument Safety information on page 8 English DANGER Electric shock hazard Always disconnect power to the instrument when making electrical connections Francais DANGER Un choc lectrique risque Toujours cou
16. attempt any repairs 3 Contact EMTEK LLC or other qualified service personnel if the unit malfunctions 4 Do not submerse the V100 controller or any sampler in any liquid Francais DANGER D charge lectrique ou Hasards d Electrocution 1 D brancher toutes les sources de pouvoir avant le fait d assurer l entretien le V100 ou le collectionneur a rien Ne d sassembler pas le V100 ou de collectionneur a rien pour faire des r parations Contacter EMTEK LLC ou d autre personnel de service qualifi pour la r paration si l unit mal fonctionne 4 Ne faire pas submerse le V100 ou le collectionneur dans aucun liquide 2 1 Referenced hazard information English DANGER Indicates a potentially or imminently hazardous situation which 1f not avoided will result in death or serious injury Francais DANGER Indique une situation potentiellement dangereuse ou imminent qui si elle n est pas vit e entrainer la mort ou des blessures graves English WARNING Indicates a potentially or imminently hazardous situation which if not avoided could result in death or serious injury Page 8 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual Francais AVERTISSEMENT Indique une situation potentiellement dangereuse ou imminent qui si elle n est pas vit e pourrait entra ner la mort ou des blessures graves English CAUTIO
17. by the user or the memory capacity is exceeded The number of samples maintained within the systems internal memory is based upon available memory and can be viewed and output to a common spreadsheet through an Ethernet connection The data maintained in the system includes set actual flow rate set actual sample volume sample start end times set delay test and hold period equipment and serial numbers calibration date and due date of the controller air sampler s and alarms during sampling Each sample may also be assigned a user defined site identifier description which will be output on the sample label and or maintained within the system memory with key sample run parameters An alphanumeric keypad is provided on the touch screen for entering user defined site identifiers descriptions All sample runs are date and time stamped and are also assigned a unique sample identification string which is comprised of the units assigned serial number and a non repeating character string up to 99 999 samples This data cannot be altered within the system of the V100 It may only be output or cleared from the system The V100 comes with a thermal printer which can utilize both paper or label stock available from EMTEK The printer outputs the defined key sample parameter data following each run if desired Additionally the user can output duplicate labels data from sample data stored in the memory buffer based on a user entered date and time range or r
18. cable end connector onto the R2S connector while threading the collar clockwise until it becomes finger tight Attach the vacuum supply tubing to the R2S sampler by placing tubing over the barb and pressing firmly to achieve an airtight fit See Section 7 5 for connection images 1 1 1 3 Attach the other end of the power supply cable to the connector on the V100 Align the two keys of the cable connector with the key way Firmly press the cable end connector in to the front panel connector while threading the collar clockwise until it becomes finger tight Attach the vacuum supply tubing to the V100 by placing the tubing into the tube connector and pressing down firmly to achieve an airtight fit See Section 7 5 for connection images 1 2 Upon completion of sanitization and set up If applicable place the R2S at the desired test site 1 3 Place the V100 outside or below e g on a cart the testing area within the constraints of the power supply cord and vacuum supply line NOTE Various lengths of power supply cable and vacuum tubing can be employed if desired dependant upon flow rate Contact EMTEK LLC for additional information 1 4 If the dome assembly has been chemically sanitized assure residual disinfectant and particulate matter from cleaning and set up are removed from the sample chamber by purging the unit prior to initiating testing 1 4 1 Plug the V100 into an available power supply 1 4 2 Turn on the V100 power sw
19. condition and the sample cycle is also terminated The alarms require an acknowledgement by pressing the OK button see Blower to High Fig 7 7 1 a and Blower too Low 7 7 1 c 02 072011 R2S 13 31 43 02 07 2011 R2S 13 30 23 ALARM Blower too high Check system ALARM Blower too low Check system for obstructions for loose connections Delay 00 00 00 Fig 7 7 1 b Blower Alarm Screens Fig 7 7 1 c Page 32 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual Test in Progress Ifa sample is in progress the set up screens cannot be accessed until the sampling period has completed or the sample is stopped Pressing the set up key while a sample is in progress activates a warning screen and requires an acknowledgement by pressing the OK button see Fig 7 7 2 cannot access the setup screens Fig 7 7 2 Test in Progress No Labels Detected Should the unit attempt to print or should the user attempt to advance a label paper and the unit is out of labels paper a warning screen will appear notifying the user see Fig 7 7 3 Fig 7 7 3 Paper Label Out Page 33 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 7 8 V100 Controller and Air Sampler Users Manual Loading Printer Paper Labels Printer Operation The V100 features an integrated thermal printer located
20. for proper operation Fig 7 9 1 Fig 7 9 2 Page 35 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual 7 10 Touch Screen Sensor Calibration The touch screen on the V100 is equipped with a calibration program To perform the calibration ensure that the main Test Sample screen is selected Fig 7 2 1 Hold one finger on the touch screen for approximately 3 seconds An indicator beep will start After the 7 beep remove your finger from the touch screen This activates the sequence of screens shown in Fig 7 10 1 Follow the on screen instructions in selecting and holding each of the cross hairs Fig 7 10 1 Steps 1 5 Once complete press the accept key Fig 7 10 1 Step 6 If the calibration sequence is not followed within 15 seconds after initiated the program returns to the Test Sample screen Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Fig 7 10 1 Touch Screen Calibration Page 36 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual 7 11 Transporting the V100 and R2S RCG Samplers The V100 comes equipped with a transport cup mounted to the top of the unit This cup is designed to securely support both the R2S and RCG samplers for transport with the aid of the collapsible handle Both the R2S and the RCG samplers slide into the transport cup from th
21. label can be affixed to the bottom of the agar plate The operator may initial and date the label if desired 1 6 5 Carefully inspect the test plate 1 6 6 Without taking the lid off the test plate assure that impingement marks are present on the agar surface and that they are reflective of the sampling period EXAMPLE 1 The plate should make one full revolution if the sample completed its set time period and air impingement marks should be present around 355 of the plate A 5 buffer is present to determine the representative start and stop time EXAMPLE 2 If the test period was stopped prior to its set time period the impingement marks should be visible around the corresponding time period as represented on the plate Half of the time period sampled would be indicative of almost half of the plate exhibiting impingement marks due to the 5 buffer EMTEK V100 001vOI FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 1 6 7 NOTE 1 6 8 1 6 9 1 6 10 1 6 11 V100 Controller and Air Sampler Users Manual If impingement marks are not present the sample test should be considered invalid unless impingement marks were noted during sampling Excessive moisture can cause issues with retaining the impingement marks see note below Due to excessive moisture of a test plate impingement marks may be erased from the agar surface Ensure that plates with excessive moisture are not us
22. on the side of the unit 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 not be operated without paper labels If the unit must be operated without paper labels in the printer set the Print Mode to Off Important Note Paper used in this printer is temperature sensitive on one side and must go into the printer as explained in the instructions Do not substitute other types of paper Important Note Due to the paper label properties it is not compatible with or intended for permanent data recording archival To install a roll of printer paper labels Fig 7 8 1 Note a Locate the printer on the back left side of the unit Pull up the handle in the center of the paper cover until a click is heard Fold the door down and remove the core from the previous roll Install the new paper or label roll so the paper feeds from the top of the roll Position the end of the paper over the black roller at the end of the printer feed door Do not thread the paper under the roller If label stock is used align the leading edge of a black Top of Form TOF mark with the center of the printer door Push the printer door back until it clicks into place Press the LABEL FEED key once on the V100 front display to align the labels The printer is now ready for operation If the paper does not feed out or
23. the selected sample time period for samplers possessing this functionality R2S RCG 3 1 Feature Summary Touch Screen Interface User friendly touch screen for intuitive operation Storage Functions 1 GB of internal flash memory for the storage of user sample sites and sample runs The quantity of the sample sites and sample runs is limited only by the available storage Compatible with Multiple EMTEK Sampling Heads Remote Slit Sampler R2S Remote Autoclavable Sampler RAS Remote Compressed Gas Confined Space Sampler RCG May operate one 1 or two 2 of the same sampling heads at the same time Can be updated to support future EMTEK samplers Thermal Printer An internal thermal paper label printer can record sample parameter information such as the sample identification unit identification set flow rate actual flow rate sample volume collected and high low flow alarms Network Input Functions Supports USB calibration programming and firmware updates Remotely view download sample parameter information Software is updatable through Ethernet connectivity IR Remote Control Supports Start Stop of the sample period Supports Pause Resume of the sample period Operates up to five 5 V100 Units Page 12 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual 3 2 Sampler Compatibility Matrix Maximum Sample Volume Collected
24. to the printer upon completion termination of the sample period Alarm occurrences are maintained within the systems internal memory with the associated sample parameter information until the memory buffer is cleared Additionally a blower alarm is also present which will produce both an audible and visual alarm if the appropriate blower speed is not maintained during operation The V100 operates the current line of EMTEK microbial air sampling heads including the R2S a slit to agar sampler RAS a sieve impaction sampler and RCG a compressed air gas and confined space sampler Each of the air samplers may be employed for testing with standard 90mm 100mm agar based microbial test plates e g Trypticase Soy Agar TSA The V100 may operate a single air sampling head at any of the three flow rates or two air sampling heads at the same time at either the 28 3 LPM or 50 LPM flow rates During single head operation an air sampler may be operated from the V100 at a distance of up to 75 feet when using at 28 3 LPM flow rate through supplied vacuum tubing and power cables For dual air sampler operation the maximum sampling distance is approximately 50 feet to each sampling head when using the 28 3 LPM flow rate In both instances the 28 3 LPM flow rate allows for the greatest distance with a reduction in the distance at 50 LPM and then again at 100 LPM for single head operation In general the lower the flow rate the farther the air sampler
25. 00 to attempt any repairs Contact EMTEK LLC or other qualified service personnel if the unit malfunctions DO NOT SUBMERSE the V100 or RCG in any liquids TAKE ALL OTHER STANDARD ELECTRICAL SAFETY PRECAUTIONS when operating the RCG Sampling Assembly with the V100 controller Francais Pour minimiser le risque DE DANGER LECTRIQUE s assurer que les primaires d alimentation Cordon d alimentation secteur n est pas branch au cours de d sinfection NE PAS retirer les panneaux ou les couvertures de la V100 de tenter toute r paration Contact Emtek LLC ou de tout autre personnel de maintenance qualifi si les dysfonctionnements unit NE PAS immerger le V100 ou RCG dans tous les liquides PRENDRE TOUTES LES AUTRES MESURES DE S CURIT lectriques standard pendant le fonctionnement du RCG chantillonnage Assembl e avec le contr leur V100 Page 41 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual A 4 RCG Sampler Assembly Set Up and Testing NOTES Before sampling with the V100 and RCG e Perform the sanitization procedure in Appendix E e The V100 and RCG Air Sampler s must be calibrated as a system with the desired configuration This includes calibration of the V100 with the air sampling head including the vacuum tubing length that will be employed during use English WARNING During compressed air gas sampling follow the proc
26. 1 6 PRINTER Turns the Printer function ON and OFF ROLL TYPE Selects either paper or labels for print function REPLICATES Set number of replicate labels 1 10 CLEAR MEMORY Clears data held in memory REPRINT Selects mode of reprint by date range and time period by number of samples or all samples LAST NUMBER OF SAMPLES Selects the number of samples to print DATE RANGE Select the date range to print TIME PERIOD Select the time period to print Note For Index 1 3 descriptions see Table 7 2 1 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual 7 3 Making Selections through Touch Screen Control Using the Function Keys SET UP NEXT SCREEN and PREVIOUS SCREEN go to the required screen Set the desired parameter using either of the following methods 1 Use the Scroll Keys lt 4 and P to highlight the desired parameter 2 Directly touch either the parameter itself or the name identifier of the parameter The method used to specify a parameter s value depends on the function of the parameter Some parameters use the Selection Keys A and V to chose the pre populated parameter value such as the Flow Rate Other parameters require the use of an alpha numeric keyboard see section 4 2 2 7 4 Using the Keyboard Function for Entering Parameters Some parameters such as the Site Sample Description require an alpha numeric entry In these cases upon
27. 1 766 or 3 531 cubic feet per minute CFM Flow Rate Control Electronic Closed Loop Mass Flow Control Maximum Tube Length Single Sampler 75 28 3 LPM 60 50 LPM 15 100 LPM Dual Sampler 50 28 3 LPM 30 50 LPM Thermal Printer Memory 1 GB flash RAM Unit ID User Defined Selectable Site ID User Defined Selectable Sample ID Unique System Generated Unit Serial 5 digit string Input Output USB Client 1 1 Ethernet 10BaseT 100 BaseT Audible Alarm Internal Alarm Limits High and Low Flow Rates User Defined Enclosure Dimensions H W D 7 x 8 x 10 inches 17 8 x 20 3 x 25 4 cm Enclosure Materials Chassis 316 Stainless Steel Cover Kydex with Microban Handle Aluminum and Nylon Weight 12 Pounds Power Ratings Auto switching 100 240 VAC 50 60 Hz 3 6 1 8A Operating Range 5 40 C 10 80 RH non condensing Indoor Use Max Altitude 6560 feet 2000 meters Calibration Flow Rate with each specific sampler hose length Calibration Frequency User Defined Recommended every 6 months Verification Turntable Rotation Timer Verification Frequency User Defined Recommended every 6 months Gas Compatibility Air and inert gases such as carbon dioxide and nitrogen Installation Category Category 2 1 and 2 Pollution Degree Air Samplers Remote Slit Sampler R2S Size 5 127mm OD 5 75 146mm H Weight 21bs 120z 1247g Materials Base Turntable Epoxy Polyester Coate
28. 63 Section 8 Appendix Appendix B Appendix C Appendix D Appendix E Appendix F Appendix 1 Appendix 2 Appendix 3 Page 3 of 75 V100 Controller and Air Sampler Users Manual Network Operation Gt the V0 tuceseketetessxccccssnaveuecesessesedcetcecssdecescteeneesseesivenseaveeeaes 38 RCG Sampler Operation for Compressed Air Gas Samp ling ccccccsssssccccssssscsccccessssssecseees 39 Al RCG Operanne Principles ae 39 Aa Me a a E E E A E E E A 40 Ao IMamtenance INSD CCONR ad de sinon desert eur uni 41 A4 RCG Sampler Assembly Set Up and Testing cc cecccccccccceeeeseeeeeeeeeeeeeeaas 42 AS SOA and Bcc 0 Fo 010 6 ae ee E 46 RCG Sampler Operation for Confined Space Sampling ccccccssssssccccssscssccccccsssssccscseeeesees 47 BL ICG Ope rari PAROISSE E ee a no tue 47 B2 NS ESS E E EE 48 B3 Mamnenance TRS D CO ae ee E E abs 49 B 4 RCG Sampler Assembly Set Up and Testing cc cecccccccccceeeeeeeeeeeeeeeeeeeaas 50 DS SOS AO POS DO a ee a er nn ane ere 53 Remote Autoclavable Sampler RAS Operation scssccssssssccsssscccssssscccsssssccecssssccsesssccssesssces 54 Cl RAS Operating Principles ecccscsicsvaccssendvnsatinevsassdannecsdinudgacdnsvenssdnabeassenpenatnaeinesdixsnies 54 CR A a eee ee 55 Co Minen IS O66 0 1 a ab oo ene ee 55 C 4 RAS Sampler Assembly Set Up and Testing 56 Go Soage and Transpor srren Eae r E A EE EEEE ER EER 59 Remote Slit Sample
29. 7 2 1 Setup Screen 1 Sampler Selection Sample and Test Information Table 7 2 1 Items on Setup Screen 1 Function EXIT SETUP Return to Main Sample Test Information Screen Keys NEXT SCREEN Move to next setup screen PREVIOUS Move to previous setup screen SCREEN Control SCROLL KEYS Move between the selectable fields left to right and top to lt and P bottom of screen Keys Control SELECTION Scroll through either a pre populated list or through KEYS numerical values depending upon the field selected Keys A and V DUE due for calibration TUBING Identifies the calibrated tubing length LENGTH SAMPLER Identifies the sampler equipment number EQUIPMENT NUMBER V100 Identifies the V100 equipment number EQUIPMENT NUMBER 5 Parameter SELECT Used to select desired sampler from list SAMPLER Keys FLOW RATE Identifies the flow rate of the selected sampler SERIAL Identifies the serial number of the selected sampler NUMBER V100 SERIAL Identifies the serial number of the V100 Controller NUMBER CALIBRATION Identifies the date that the selected sampler V100 were DATE calibrated CALIBRATION Identifies the date that the selected sampler V100 are next Page 22 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual sec ASA Screen 2 ieee e i SE De CELL CULTURE 3 Current Device R25 cae 6 NEXT Unit
30. General Requirements Issued 2004 07 01 Ed 2 The technical documentation required to demonstrate that the products meet the requirements of the Low Voltage Equipment directive has been compiled and is available for inspection by the relevant enforcement authorities It is held at the manufacturers given address The CE mark was first applied in 2010 Signed SS Date 4 March 2010 Name Erik Swenson Position Managing Member EMTEK LLC Attention The attention of the specifier purchaser installer or user is drawn to special measures and limitations to use which must be observed when these products are taken into service to maintain compliance with the above directives Details of these special measures and limitations to use are available on request and are also contained in the product manuals EMTEK LLC 1430 Nelson Rd Suite 210A Longmont Colorado USA www emtekair c Telephone 303 682 3168 Fax 303 223 2804 E mail sample Page 71 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual Appendix 2 Two Year Warranty EMTEK LLC 1430 Nelson Rd Suite 210A Longmont Colorado 80501 USA TEL 877 850 4244 e mail sample emtekair com www emtekair com Standard Two Year Warranty Customer satisfaction is a prime objective of EMTEKEK LLC EMTEK Toward that objective the products offered by EMTEK have been designed manufactur
31. Mount is color coded for each flow rate as follows 28 3 LPM Dome White 50 LPM Dome Green 100 LPM Dome Blue e Sanitary Sample Tubing Assembly and sanitary fitting clamps single or multiple Autoclaved or Chemically Sanitized for use e Standard 90 mm Test Plates e g TSA Agar e Incubator s e g 30 35 C and or 20 25 C e Gloves Sterile or Clean e Low Particulate Shedding Wipes e g Wipe All Gamma Wipes or equivalent better e Disinfectants e g Quaternary Ammonia Compounds 70 0 2um filtered or sterilized alcohol Important Note Phenolic disinfectants should not be used on the Clear Dome Assembly as they will cause them to become brittle e Lab Marker e Adhesive Tape Page 48 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual B 3 Maintenance Inspection To assure appropriate operation of the RCG sampling assembly prior to each days use sampling personnel should inspect the unit for any obvious physical defect This inspection shall include but not be limited to the following e A visual check of the dome to base seal or dome assembly to assure it is not visibly damaged in a way that would keep it from sealing appropriately tears in the seal cracks or chips in the dome etc e A visual check that the spring loaded dome assembly retention clip is functional and free from defect e The sample slit of the sample
32. N Fig 7 5 4 a RAS With and Without Vacuum Supply Connection DUAL RAS HEAD OPERATION VACUUM TUBING CONNECTIONS Fig 7 5 4 b Dual RAS Tubing Connection Steps Page 29 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual SINGLE R2S RCG HEAD OPERATION CONNECTIONS FOR POWER AND VACUUM Fig 7 5 5 a R2S RCG With and Without Power and Vacuum Supply Connection DUAL R2S HEAD OPERATION CONNECTIONS FOR VACUUM AND POWER SPLITTERS Fig 7 5 5 b Fig 7 5 5 c Connecting Vacuum Tubing and Power Cables to Splitters on V100 Page 30 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual 7 6 IR Remote Control Fig 7 6 1 IR Remote Control Table 7 6 1 Functions of Remote Control Operation of 1 to 5 V100 Units Identifies Unit 2 for On Off and Pause Resume Functions Identifies Unit 3 for On Off and Pause Resume Functions Identifies Unit 4 for On Off and Pause Resume Functions Identifies Unit 5 for On Off and Pause Resume Functions 7 6 1 Loading the Batteries into the Remote Control iF 2 ee Remove the battery cover Insert two AAA batteries Ensure that the poles and are correctly positioned Replace the battery cover 7 6 2 Operating the V100 Unit 1 with the Remote Control I 2 Page 31 of 75 To start the sampling period pr
33. N Indicates a potentially hazardous situation that may result in minor or moderate injury Francais ATTENTION Indique une situation potentiellement dangereuse qui mai entra ner des blessures plus ou mod r e blessure Important Note Indicates a situation which if not avoided may cause damage to the instrument Information that requires special emphasis Note Importante Indique une situation qui si non vit peut provoquer le dommage a le instrument Les informations qui exigent l accentuation sp ciale Note Information that supplements points in the main text 2 2 Precautionary labels Read all labels and tags attached to the instrument Personal injury or damage to the instrument could occur if not observed English Electrical equipment marked with this symbol may not be disposed of in European public disposal systems after 12 August of 2005 In conformity with European local and national regulations EU Directive 2002 96 EC European electrical equipment users must now return old or end of life equipment to the 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 Francais Les quipements lectriques marqu s de ce symbole mai ne pas tre limin s dans les syst mes europ ens
34. Sample i Sampler Part Rate Max Sample Period i i Period Liters min Minutes Liters m3 ft3 60 1700 1 7 60 V100 R2S 28 28 3 r 240 6800 6 8 240 20 1000 1 35 V100 R2S 50 50 40 2000 2 70 10 1000 1 35 V100 R2S 100 100 20 2000 2 70 20 1000 1 35 V100 RCG 50 507 40 2000 2 70 10 1000 1 35 V100 RCG 100 100 20 2000 2 70 Note The RCG is only available for Compressed Air Gas sampling at 50 LPM in conjunction with EMTEK s Micro High Pressure Diffuser for pressure ranges from approximately 15 115 PSI 1 Test Delay Hold Run function allows for extension of total sample hold time period to 120 minuites with the RAS and RCG and 480 minutes per test plate when sampling with the R2S All Test Delay Hold Run cycles should be qualified by the user 2 The V100 software allows for extended sampling periods up to 240 minutes with the R2S 3 All Sampling periods should be qualified by the user Note Additional Domes for the 28 3 50 and 100 LPM Sample Rates for the R2S and RCG can be purchased separately Page 13 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual 3 3 Unpacking or Packing Remove all items from the shipping container and inspect them for damage Make sure that all of the items listed are included Fig 3 3 1 dependent upon purchase options If any of the items not marked optional
35. Sampler Assembly Set Up and Testing NOTES Before sampling with the V100 and RCG Perform the sanitization procedure in Appendix E The V100 and RCG Air Sampler s must be calibrated as a system with the desired configuration This includes calibration of the V100 with either single or dual air sampling heads including the vacuum tubing length that will be employed during use 1 RCG Sampling Assembly Set Up and Testing 1 1 1 2 1 3 1 4 Attach the RCG power supply cable and vacuum supply tubing 1 1 1 Attach the appropriate end of the power supply cable to the connector on the RCG sampler Firmly press the cable end connector onto the RCG connector while threading the collar clockwise until it becomes finger tight Attach the vacuum supply tubing to the RCG sampler by placing tubing over the barb and pressing firmly to achieve an airtight fit See Section 7 5 for connection images Attach the other end of the power supply cable to the connector on the V100 Firmly press the cable end connector in to the front panel connector while threading the collar clockwise until it becomes finger tight Attach the vacuum supply tubing to the V100 by placing the tubing into the tube connector and pressing down firmly to achieve an airtight fit See Section 7 5 for connection images Place the RCG at the desired test site e g on a bench cart table etc within the constraints of the vacuum power cable assembly and sanitary sa
36. V100 001v01 FEB2011 FLOW RATE TEST VOLUME SAMPLE TIME TEST HOLD DELAY START STOP PAUSE RESUME SETUP LABEL FEED PLATE SAMPLE TIME TRACKING Indicates the current state of a test period Ramp Delay Test Hold Pause Abort and countdown of a test period Indicates the selected flow rate and actual flow rate during the sample period Indicates the selected volume Liters Cubic Feet Cubic Meters and actual volume collected during the sample period Indicated the selected sample time and the elapsed time of the sample period Indicates the selected test period hold period and initial delay before test period Start Stop sample period Key changes to read Start or Stop upon activation Pause Resume sample period Key changes to read Pause or Resume upon activation Access to setup screens See 3 2 Advances individual labels Visual indication of elapsed sample period for RAS or plate rotation for R2S RCG plate or period not completed plate or period completed Test period completed V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual 7 2 Touch Screen Setup Screens 1 4 2 1 liCal ed Flow Rate 28 3 Do 5 Bi iR2S Serial 02345 V100 Serial 01234 Calibration Date 01 02 10 i i 2 PREVIOUS i Calibration Due 07 02 10 0124 ee Tubing Length 12 0 R25 Equipment 02345 V100 Equipment 9876543210 Fig
37. V100 Controller and Air Sampler Users Manual CAA I Care MICROBIAL AIR SAMPLERS V100 Controller and Air Sampler Users Manual Contact Us for Customer Service and Technical Support EMTEK LLC 1430 Nelson Dr Suite 210A Longmont CO 80501 Website http www emtekair com Phone 877 850 4244 Email emtek emtekglobal com Fax 303 223 2804 Page 1 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual Table of Contents Section 1 Section 2 Section 3 Section 4 Section 5 Section 6 Section 7 Page 2 of 75 DS PG CURL C AGUNG assassinas aaa AANEEN 4 CTE AA T CE MAGE TE eee Re 5 2 1 Document DESCHO TOM ei ccccinsdstsonvacdertduedddsadeailndtostseradardacdatsdatieeddedsaneestentdusdddeasiondsiadds 5 22 PAN SUS in nt 5 2 5 COD o 0 Sane eee ee ete ne ned ee Ree E ee ee ee oe ere enter 5 2 4 DSC ARR a de nn ao bi 5 2 5 LICE DSC RSA OM ae eee ee ee er ee ra a ere 0 5 2 6 V 100 Technical Des er POM ride nsc atedinserne une 6 2 NOR ot 8 2 1 WReterenced Hazard Informal Omsen sner aAA EE EER 8 212 Precautionary LaDelS reenson ne te tr en ccm ae 9 26 SAndardsand RG OU IAG OM ee nee en bete etat 11 26 1 CE Declaration of Conformity nn tee n ia 11 20 2 ACPRPIA IT 8 40 9 02 0 rs ae ee AE O 11 L A aE E EE E E TEE 11 Produce PA 0 20 L DO COM ES et een ee ee Een en 12 3 1 PANN SAV a 12 3 2 Samp
38. activation of the selected parameter a screen displays a variety of options Add Entry Edit Entry Delete Entry Cancel see Figure 4 5 e Selecting Add Entry allows you to create an additional Site Sample e Selecting Edit Entry allows you to edit the chosen Site Sample description e Selecting Delete Entry allows you to delete the chosen Site Sample description e Selecting Cancel returns you to the previous screen kn Figure 7 4 1 Site Sample Description Parameter Screen Page 26 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual When you select the Add Entry or Edit Entry button a keyboard is displayed see Figures 7 4 2 and 7 4 3 Fig 7 4 2 Keyboard Alpha Display The keyboard allows input using a standard QWERTY keyboard If numerical values are required select the 123 button 1 in the lower left corner and a numeric keyboard is displayed see Figure 4 7 Fig 7 4 3 Keyboard Numeric Symbol Display In the numeric symbol mode the original entry is retained and additional numbers or symbols can be added to the text To switch back to the alpha keyboard select the ABC button in the lower left corner 1 When you finish creating the entry select Enter 2 and the entry is saved Page 27 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63
39. ator Initials etc The paper can be retained or the label can be affixed to the bottom of the agar plate or required paperwork For sinlge head sampler operation it is ideal to set the Replicate Label Count to 1 for labeling of each plate see Section 7 2 Setup Screen 4 details The operator may initial and date the printout if desired Carefully inspect the test plate 10 7 4 6 1 Without taking the lid off the test plate assure that impingement marks are present on the agar surface and that they are reflective of the sampling period EXAMPLE The plate should make one full revolution if the sample completed its set time period and air impingement marks should be present around approximately 355 of the plate A 5 buffer is present to determine the representative start and stop time V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual EXAMPLE 2 If the test period was stopped prior to its set time period the impingement marks should be visible around the corresponding time period as represented on the plate Half of the time period sampled would be indicative of almost half of the plate exhibiting impingement marks due to the 5 buffer 10 7 4 6 2 If impingement marks are not present the sample test should be considered invalid unless impingement marks were noted during sampling Excessive moisture can cause issues with retaining the impingement marks s
40. d Aluminum 316SS Aluminum Components Inlet Dome Clear Polycarbonate Seal Blue Fluorosilicone Drive Motor Stepper Electrical Connector 4 Pin Remote Compressed Size 5 127mm OD 6 75 171mm H Weight 3lbs 20z 1417g Materials Base Turntable Epoxy Polyester Gas Confined Space Sampler Coated Aluminum 316SS Aluminum Components Inlet Dome Clear Polycarbonate with aluminum 316 SS RCG inlet throat Seal Blue Fluorosilicone Drive Motor Stepper Electrical Connector 4 Pin Remote Autoclavable Sampler Base Inlet Cover Barb 316 Stainless Steel or Aluminum Seals Blue Fluorosilicone Dimensions 4 125 105mm RAS OD x 1 5 38mm H Weight 3lbs 5oz 1503g 316SS Page 4 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual Section 2 General Information 2 1 Document Description Document EMTEK V100 001v01 Second Edition February 2011 This document remains the official reference source for all revisions releases of this product until rescinded by an update including current and updated versions of the operating firmware and software 2 2 Patents e The R2S sampling technology is patented U S Patent No 5831182 e V100 Controller Patent Pending 2 3 Copyright 2011 by EMTEK LLC All rights reserved 2 4 Disclaimer It is the policy of EMTEK LLC to improve this manual and the products it describes as new
41. d or the label can be affixed to the bottom of the agar plate or required paperwork For dual sampler operation it is ideal to set the Replicate Label Count to 2 for labeling of each plate see Section 7 2 Setup Screen 4 details The operator may initial and date the printout if desired 1 9 If additional samples are to be taken at the same location during the same test period e g for continuous process monitoring repeat Steps 2 4 through 2 4 5 for each additional sample required 1 10 When testing is complete at a specified location 1 10 1 Turn off unit power and disconnect from AC power supply 1 10 2 Sanitize the RAS sampling assembly to remove any contaminants or test media 1 11 If additional samples are to be taken at different locations in the same area on the same day move the RAS Sampling Assembly 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 1 e moved from one classified area to another it is suggested to repeat applicable sanitization procedures in the next area prior to monitoring C 5 Storage and Transport I For transport convenience 1 1 The RAS sampler should be placed in a clean sterile bag for transport 1 2 The V100 vacuum tube sampler cable and power cord can be coiled and can be placed over the V100 handle when in the extend position for transport if desired or within a clean sterile bag 2 For transport outside
42. e rear and seat under a supporting rim on the transport cup The bottom of both the R2S and RCG samplers are concave and accept the raised circular center of the transport cup for a secure fit Once secure within the transport cup the transport handle can be extended and raised to a position above the sampler Use the handle to transport the V100 and R2S RCG sampler to the desired location Once in the desired location the handle can be returned the rear of the V100 and collapsed into its storage position When removing the samplers ensure that the handle is out of the path of the sampler lift the sampler up slightly and slide to the rear of the transport cup Page 37 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual Section 8 Network Operation of the V100 The V100 controller stores Sample Run Data Run Data up to the limit of the internal 1 GB memory This memory is flash RAM that is not removable or alterable by the user The USB port is provided to allow for the Calibration of the unit via an external Calibration Software Program Contact EMTEK LLC for more information regarding the Calibration Software Program The Run Data maintained in the system includes set actual flow rate set actual sample volume sample start end times set delay test and hold period calibration date and due date of the controller alarms during sampling user samp
43. ed and field tested with care and technical competence 1 In any instance where an EMTEK instrument fails to perform to the customer s satisfaction itis EMTEK S policy to provide prompt and effective investigation of the situation 2 EMTEK warrants that products of its manufacture will perform according to stated specifications and that the products will be free from defects in workmanship and materials provided that the defect of malperformance occurred under normal and proper use of the products Decision regarding such normal and proper use will be made by EMTEK following factory inspection and investigation of the application 3 Claims under the terms of this warranty must be submitted in writing within a period not not exceeding 24 months following dateof shipment of the product from EMTEK to the purchaser All products on which warranty claims are established must be submitted to EMTEK within the specified time period to the EMTEK business address unless otherwise specified by EMTEK in writing with freight transportation charges prepaid Products judged by EMTEK to be defective will be repaired or replaced and returned to the customer with return freight transportation charges prepaid by the customer 4 EMTEK reserves the right to disallow claims for warranty coverage in instances where there is evidence that the EMTEK product has been placed in a severe or corrosive atmosphere outside the specified operating parameters spec
44. ed to avoid this situation Assure all applicable information is recorded on the test plate as required Upon completion of the test period a printout label or Paper tape is generated from the on board thermal printer with the sample parameter information e g Sample Start Stop Time Site Date Operator Initials etc The paper can be retained or the label can be affixed to the bottom of the agar plate or required paperwork For dual head sampler operation it is ideal to set the Replicate Label Count to 1 for labeling of each plate see Section 7 2 Setup Screen 4 details The operator may initial and date the printout if desired Repeat the applicable portions of this procedure for additional samples A newly sanitized sample tubing assembly may be used for each sample Chemical sanitization or at least purging of the dome assembly should be performed at each sample location to assure a representative sample from that location following each set up B 5 Storage and Transport 1 For transport convenience 1 1 The RCG sampler should be placed in the transport mount located at the top of the V100 controller for transport or for storage see Section 7 11 1 2 The V100 vacuum tube sampler cable and power cord should be coiled and can be placed over the V 100 in the transport mount 1 3 For transport outside of the facilities the entire assembly may be placed in a bag to minimize possible contamination of the unit
45. edure as stated to minimize the risk of injury from testing of these high pressure systems Safety glasses and or a face shield should be worn at all times Francais AVERTISSEMENT Lors de l air comprim d chantillonnage de gaz de suivre la proc dure comme il est indiqu pour r duire au minimum le risque de blessures en cas de test de ces syst mes haute pression Lunettes de s curit et ou un masque facial doit tre port en tout temps 1 Attach the RCG power supply cable and vacuum supply tubing as follows 1 1 Attach the appropriate end of the power supply cable to the connector on the RCG sampler Align the two keys of the cable connector with the key way Firmly press the cable end connector onto the RCG connector while threading the collar clockwise until it becomes finger tight Attach the vacuum supply tubing to the RCG sampler by placing tubing over the barb and pressing firmly to achieve an airtight fit See Section 7 5 for connection images 1 2 Attach the other end of the power supply cable to the connector on the V100 Align the two keys of the cable connector with the key way Firmly press the cable end connector in to the front panel connector while threading the collar clockwise until it becomes finger tight Attach the vacuum supply tubing to the V100 by placing the tubing into the tube connector and pressing down firmly to achieve an airtight fit See Section 7 5 for connection images 2
46. ee note below Note Due to excessive moisture of a test plate impingement marks may be erased from the agar surface Ensure that plates with excessive moisture are not used to avoid this situation 10 7 5 Ensure that all applicable information is recorded on the test plate The printer in the V100 can be used to print a printout label with this information 10 7 6 Repeat the applicable portions of this procedure for additional samples A newly sanitized sample tubing assembly may be used for each sample Chemical sanitization or at least purging of the dome assembly should be performed at each sample location to assure a representative sample from that location following each set up A 5 Storage and Transport 1 For transport convenience 1 1 The RCG sampler should be placed in the transport mount located at the top of the V100 controller for transport or for storage see Section 7 11 1 2 The V100 vacuum tube sampler cable and power cord should be coiled and can be placed over the V 100 in the transport mount 1 3 For transport outside of the facilities the entire assembly may be placed in a bag to minimize possible contamination of the unit 1 4 A cover e g sanitary cap or bioshield may be placed over the sanitary fitting opening of the sample conduit of the RCG dome assembly during transport and storage to minimize contamination 2 Store the V100 and RCG assemblies in a clean and dry place 3 The sanitary
47. equested number of samples The user may also set a specified number of replicate samples that will print at the end of each run This is convenient when operating two sampling head with one controller when setting the replicate value to print two labels Sample runs on the V100 can be initiated through either the V100 touch screen Run Display screen or the supplied Infrared Remote IR Remote From either the V100 display or the IR Remote the user can START PAUSE RESUME or STOP a sampling session The IR Remote allows for these functions at a distance of up to 40 Feet or approximately 12 meters with line of site to the V100 IR Receiver window located just above the touch screen display on the V100 Page 7 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual 2 7 Safety Notices Please read this entire manual before operating this equipment Pay attention to all danger warning and caution statements Failure to do so could result in serious injury to the operator or damage to the equipment To make sure that the protection provided by this equipment is not impaired do not use or install this equipment in any manner other than that specified in this manual English DANGER Electric Shock or Electrocution Hazards 1 Disconnect all power sources before servicing the V100 or any sampler 2 Do not disassemble the V100 controller or any sampler to
48. ess the Start key of the unit to be operated To start the sampling period press the Start On P key To pause the sampling period press the On P key while the unit is sampling To resume the sampling period press the On P key and the sample period resumes To stop the sampling period press the End key EMTEK V100 001vOI FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual 7 7 Alarms Warning Screens Flow Alarms During operation the V100 detects high and low flow rates Alarms are triggered based on user defined thresholds between 0 25 see Fig 7 2 3 7 If the required flow rate differs by more that the defined threshold for more than ten seconds an alarm screen appears and requires an acknowledgement by pressing the OK button see Fig 7 7 1 a 31 08 2009 R2S E ALARM Flow rate too low Check systen for obstructions Fig 7 7 1 a Flow Alarm Screen Blower Alarms CONTACT EMTEK FOR USE OF BLOWER ALARMS If blower Alarms are set through the unit internal Configuration File not through the Set Up Menu screens During operation the V100 detects high and low blower power voltages conditions Alarms are triggered based on set threshold values ranging from 5 to 50 100 blower alarms off If the required flow rate differs by more that the defined threshold for more than ten seconds an alarm screen appears stating the high or low blower
49. etter e Disinfectants e g Quaternary Ammonia Compounds 70 0 2um filtered or sterilized alcohol Important Note Phenolic disinfectants should not be used on the Clear Dome Assembly as they will cause the dome to become brittle in a short period of use e Lab marker Page 40 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual A 3 Maintenance Inspection To assure appropriate operation of the RCG sampling assembly prior to each days use sampling personnel should inspect the unit for any obvious physical defect This inspection shall include but not be limited to the following e A visual check of the dome to base seal or dome assembly to assure it is not visibly damaged in a way that would keep it from sealing appropriately tears in the seal cracks or chips in the dome etc e A visual check that the spring loaded dome assembly retention clip is functional and free from defect e The sample slit of the sample throat shall be visually inspected to assure that it is free of occlusions to assure proper sample flow through the slit If any maintenance need be performed contact appropriate service or repair personnel IMPORTANT SAFETY PRECAUTIONS English TO MINIMIZE THE CHANCE OF ELECTRICAL HAZARD assure that the primary AC power supply cord is not plugged in during sanitization DO NOT REMOVE THE PANELS or COVERS of the V1
50. event damage with the equipment Fran ais Ce symbole indique la pr sence de dispositifs sensibles Electro Static Discharge ESD et a indiqu que les soins doivent tre prises pour pr venir les dommages aux quipements English This symbol indicates that a risk of electrical shock and or electrocution exists Fran ais Ce symbole signifie qu il existe un risque de choc lectrique et ou d lectrocution existe EMTEK V100 001vOI FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual 2 8 Standards and Regulation 2 8 1 CE Declaration of Conformity See Appendix 1 2 8 2 21 CFR Part 11 Compliance Sample Parameter Information and Electronic Records The V100 controller stores sample parameter information up to the limit of the internal 1 GB memory This memory is flash RAM that is not removable or alterable by the user The sample parameter information maintained in the system includes set actual flow rate set actual sample volume sample start end times set delay test and hold period calibration date and due date of the controller alarms during sampling user sample description and unique sample identifier The stored sample parameters can be cleared deleted by the user but cannot be edited Further sample parameter information of a specific sampling event cannot be selectively deleted or altered by the user The V100 can re print sample parameter i
51. g and download copying of the Run Data stored in the V100 s configuration file While connected to a LAN or Hub as described above perform the following 1 Open the Run Command Line on a PC and enter emt runs 2 The represents the setting of the IR ID on Set up Screen 4 Example If your V100 is set to IR ID 1 you would enter emtl runs 3 The first time you connect with your computer you will be asked for a user ID and Password Use emtek in both the User ID and Password prompts The PC will likely remember the User ID Password 4 Selecting OK will take you to the following Directory on the V100 These files are the individual sample run files 5 Double clicking a sample run file brings up the sample run parameter data for that run 6 The data files can be saved to your desktop or specified file The data cannot be modified and saved on the V100 unit IMPORTANT NOTE Once the data is saved outside of the V100 system the data integrity is not guaranteed by EMTEK EMTEK LLC does not provide outside software that is 21 CFR Part 11 compliant Downloaded sample parameter data must be handled by the user in a compliant manner Page 38 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual Appendix A Remote Compressed Gas RCG Sampler Operation for Compressed Air Gas Systems This section describes the procedure to monit
52. he user the capability of entering an initial sample delay as well as hold and test periods for each sample run This initial sample delay allows the user time to exit the immediate area of the sample location while the hold and test period settings allows for intermittent sampling of an area or process for an extended time period as determine appropriate by the user For an example the user may set an initial delay period of 3 minutes and then opt to sample for 5 minute periods with 5 minute hold periods between each 5 minute sampling period which will occur for a period up to the maximum total sampling period defined for the flow rate chosen If the flow rate chosen is 28 3 LPM the maximum active sampling period allowed is 60 minutes This would allow for twelve 12 5 minute test periods followed by eleven 11 5 minute hold periods for a total plate exposure time of 118 minutes including the 3 minute initial delay This would result in a total of 60 minutes of active sampling The motor powers down during hold periods EMTEK recommends only 120 minutes of total plate exposure including sampling and hold periods but users may qualify other total plate exposure periods if longer hold periods are desired At the 28 3 LPM sample rate the software allows for up to 8 Hours of total plate exposure which includes total sampling and hold periods The V100 maintains key sample parameter data within its internal memory until the memory buffer is cleared
53. ified for the product 5 Similarly this warranty will be invalidated in instances where the malperformance is attributable to tampering or adjustment by other than factory approved personnel 6 EMTEK s Liability under the terms of this warranty is limited to repair or replacement of defective of products at no charge to the customer EMTEK expressly disclaims any liability to its customers sales representatives or users of its products or to any other person or persons for consequential damages of any kind arising out of or in any way connected with the use or EMTEK s products Representations and warranties made by any person including sales representatives of EMTEK which are inconsistent or in conflict with the terms of this warranty shall not be binding upon EMTEK unless specifically stated in writing and approved as a document supplementary to this warranty by an authorized officer of the EMTEK organization EMTEK WRNT MAR 2010 Page 72 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual Appendix 3 Packaging Materials and Packaging of Components Maintain all Custom Packaging Components for System Shipments V100 Controller Shipping Cage Load Cage Base into Shipping Box place V100 Place Cage Top BASE TOP V100 in Bottom of Cage Cage Top On Air Sampler Component Trays Tray Cover Manual Cable Tray amp Loading Air Sampler
54. itch at the bottom back corner of the unit 1 4 3 Set the sample parameters on the V100 to sample for approximately 2 minutes See Section 7 Page 63 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 1 4 4 1 4 5 1 4 6 1 4 7 V100 Controller and Air Sampler Users Manual Press the Start key on the V100 or on the remote to start the blower Once the blower ramps up to the appropriate flow rate sampling on the V100 will begin The V100 will stop once the selected sample volume is attained Check to ensure that the dome assembly is physically dry Repeat steps 1 4 4 through 1 4 7 if necessary 1 5 Begin testing by following the steps below 1 5 1 Page 64 of 75 Set the sample parameters on the V100 to sample for the desired flow rate and sample volume sample time etc see Section 7 NOTE An initial sample delay can be set to allow for clearance of the area by personnel prior to the start of sampling A test hold function is also available as well as IR remote control see Section 7 Aseptically place the test plate e g 90 mm TSA plate on the turntable as follows NOTE Gloved hands should be cleaned with a disinfectant e g 70 alcohol immediately prior to performing these steps Lift up the dome assembly just high enough to place the test plate on the turntable and remove its lid Without inverting place the lid of the test plate face down on a pre sani
55. le description and unique sample identifier The stored sample parameters can be cleared deleted by the user but cannot be edited Further sample parameter information of a specific sampling event cannot be selectively deleted or altered by the user The V100 is equipped with an Ethernet 10BaseT 100 BaseT Port that will allow for an outside program to view or extract the Sample Run Data Run Data The Sample Run Data can be downloaded or viewed but cannot be modified while within the units memory The Run Data may be viewed through a WEB browser as follows 1 Attach the V100 to a Local Area Network LAN connection or to a separate Ethernet hub through the Ethernet port 2 Connect a computer PC to the LAN or to the Ethernet Hub 3 Open up a WEB browser e g Windows Explorer on the PC 4 Inthe Address Line of the browser enter the following URL http emt runs where the is equal to the Infrared Remote IR Number IR ID as selected displayed on Set Up Screen 4 Fig 7 2 4 8 5 This will display the Run Files currently stored in the V100 memory Double clicking on each Run File will open a new window view of the individual sample run parameters 6 If viewing the run data while a run is in progress on the V100 you will be able to see the current run data only when the run is complete by using the refresh button on the browser The Run Data may be viewed through PC Command Line access allowing direct viewin
56. ler COMPANY WI ALIX sesers nr ed ont 13 3 3 Wimp ae ki or PACKS cds en A ae era ee ee 13 DVS EI PT 0 ne cneecas E E E 15 4 1 Wiring Safety Information o5 cinsecrsnesazoghagrencycnwentsnsesavviehrancioa vaverdabieactexaseasabwaesseees 15 4 2 Electrostatic Discharge ESD Considerations 15 4 3 Tiec iea C one OS enra E E er er 17 Dy CS CR POND sosire n ane en 18 5 1 OO PARENT ee eyo E ae em ot pot sus E een A E OE ESR 18 22 VIDOR y O a e E E E te aedselne ae 19 OUE SCAT E aee sss cavecvanncaceasesseecsnasacs 20 Operae Tas a OS sss 21 7 1 Touch Screen Test Sample Screen 5 animes AE E AAE 21 T2 Touch Screcn Setup Screens 14 eneeier niaan E T 72 7 3 Making Selections Through Touch Screen Control 26 7 4 Using the Keyboard Function fo Entering Parameters 26 7 5 Connecting the SAMPEL S a sb act A ane 28 7 6 MS IS E a E E A E oo 31 7 6 1 Loading the Batteries into the Remote Control 31 7 6 2 Operating the V100 with the Remote Control 31 7 7 Arms WW at CT C11 a ES 32 7 8 Loading Printer Paper Labels Printer Operation 34 7 9 Replacing be HEPA Fite i ss ndine TENA ESE i ea remets 35 TAO Touch Sereen Sensor CalibratiOl 2 Ern nianna NEA ANARA ENE Aia E 36 7 11 Transporting the V100 and R2S RCG Samplers 37 EMTEK V100 001vOI FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1
57. m the V100 located outside of or away from the critical environment or test area through a 0 2 micron HEPA filter During testing the test plate rotates on the turntable with one full revolution in the time period selected This rotation removes recovered organisms from the direct path of incoming air to help prevent their desiccation allows for easier enumeration of isolates recovered and for the determination of the approximate time of their recovery Upon completion of the test period the test plate is removed from the R2S and is incubated for a designated time period at a specified temperature Following the required incubation period the numbers of bacterial Colony Forming Units CFU are enumerated for the sampled volume of air The density of air borne bacteria per volume of air tested can then determined based upon the total CFU recovered in the total volume of air sampled Page 60 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual D 2 Materials e EMTEK R2S Air Sampler and V100 Controller calibrated for operation at 28 3 50 and or 100 LPM with power cable and vacuum tubing assembly e R2S Dome for 28 3 50 or 100 LPM Distance Indicator Mount is color coded for each flow rate as follows e Standard 90 mm Test Plates e g TSA Agar e Incubators e g 30 35 C and or 20 25 C e Gloves Sterile or Clean e Low Particulate Sheddi
58. mple tubing e g 2 feet Attach one end of the sanitized or autoclaved sanitary sample tubing seal to the desired location using a sanitary clamp assembly Attach the other end of the sample tubing assembly to the sanitary fitting on the RCG sample inlet using a sanitary clamp If the dome assembly has been chemically sanitized assure residual disinfectant and particulate matter from cleaning and set up are removed from the sample chamber and dome assembly by purging the unit prior to attaching the vacuum tubing to the RCG sampler 1 4 1 1 4 2 1 4 3 NOTE Page 50 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 Turn on the V100 power switch at the bottom back corner of the unit Set the sample time for 2 3 minutes at the desired flow rate see Section 7 Assure that the dome assembly retention clip is in place The dome assembly retention clip is intended to retain the dome in place during set up and purging V100 Controller and Air Sampler Users Manual 1 4 4 Press Start on the V100 or on the remote to initiate the blower motor 1 4 5 Once the sample completes determine if the inside of the RCG 1s visibly dry Repeat steps 1 4 2 through 1 4 4 as required until dry 1 5 Initiating Testing 1 5 1 Set the desired sample parameters on the V100 See Section 7 1 52 Remove the retention clip from the top of the dome assembly and place it on the edge of the dome seal
59. n etc as applicable The printer in the V100 can be used to print a label or paper tape with this information 1 6 6 Repeat the applicable portions of this procedure for additional samples A newly sanitized dome assembly may be used for each sample Chemical sanitization or at least purging of the dome assembly should be performed at each sample location to assure a representative sample from that location following each set up D 5 Storage and Transport 1 For transport convenience 1 1 The R2S sampler can be placed in the transport mount located at the top of the V100 controller for transport or for storage see Section 7 11 1 2 The V100 vacuum tube sampler cable and power cord can be coiled and can be placed over the V100 in the transport mount 2 For transport outside of the facilities the entire assembly may be placed in a bag to minimize possible contamination of the unit 3 A cover e g sanitary cap or bioshield may be placed over the sample conduit of the R2S dome assembly during transport and storage to minimize the potential of contamination Page 66 of 75 EMTEK V100 001v01 FEB2011 Store the V100 and R2S assemblies in a clean and dry place V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual Appendix E V100 Controller and Air Sampler Sanitization This section applies to the V100 Controller and all air samplers as specified V100 Ai
60. n automatically stop 1 6 1 1 If desired the test period can be terminated by pressing the Stop key on the V100 or remote control at any time during the testing period Aseptically remove the test plate from the turntable as follows NOTE Gloved hands should be rinsed with disinfectant immediately prior to performing these steps 1 6 2 1 Remove the dome from the R2S sampler with one hand and with the other hand replace the lid of the test plate being careful not to touch the inside of the lid or the agar surface Do not move your hand over the exposed surface of the test plate Allow the lid to lead your hand over the test plate as you replace it 1 6 2 2 Remove the test plate with the lid in place from the turntable and place the dome back on the R2S sampler 1 6 2 3 Secure the lid to the test plate with tape Assure all applicable information is recorded on the test plate as required Upon completion of the test period a printout label or Paper tape is generated from the on board thermal printer with the sample parameter information e g Sample Start Stop Time Site Date Operator Initials etc The paper can be retained or the label can be affixed to the bottom of the agar plate or required paperwork For dual sampler operation it is ideal to set the Replicate Label Count to 2 for labeling of each plate see Section 7 2 Setup Screen 4 details The operator may initial and date the printout if desired Carefully ins
61. nformation using a built in thermal printer The user can select a date and time range or specify the number of samples to be printed The sample parameter information stored in the internal memory of the V100 controller can be either printed to the onboard thermal printer or transferred to an external computer through an Ethernet connection This sample parameter information can be deleted but cannot be altered while residing within the internal memory of the V100 controller This sample parameter information may be exported from the internal memory EMTEK LLC does not provide software utilities to comply with the requirements of 21 CFR Part 11 after the data is transferred from a V100 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 a V100 controller to an external source 2 9 Warranty EMTEK LLC provides a 2 Year Limited Warranty See Appendix 2 Page 11 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual Section 3 Product Introduction The V100 is a state of the art 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 Stepper motor control ensures a complete rotation of the testing plate in
62. ng Wipes e g Wipe All Gamma Wipes e Disinfectants e g Quaternary Ammonium Compounds 70 0 2um filtered or sterilized alcohol e Lab Marker as required e Adhesive Tape Page 61 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual D 3 Maintenance Inspection To assure appropriate operation of the R2S sampling assembly prior to each day s use sampling personnel should inspect the unit for any obvious physical defect This inspection shall include but not be limited to the following e A visual check of the dome to base seal or dome assembly to assure it is not visibly damaged in a way that would keep it from sealing appropriately tears in the seal cracks or chips in the dome etc e A visual check of the sample throat to assure that it is free of occlusions to assure proper sample flow through the slit If any maintenance need be performed contact appropriate service or repair personnel IMPORTANT SAFETY PRECAUTIONS English TO MINIMIZE THE CHANCE OF ELECTRICAL HAZARD assure that the primary AC power supply cord is not plugged in during sanitization DO NOT REMOVE THE PANELS or COVERS of the V100 to attempt any repairs Contact EMTEK LLC or other qualified service personnel if the unit malfunctions DO NOT SUBMERSE the V100 or RCG in any liquids TAKE ALL OTHER STANDARD ELECTRICAL SAFETY PRECAUTIONS when operati
63. ng the RCG Sampling Assembly with the V100 controller Francais Pour minimiser le risque DE DANGER ELECTRIQUE s assurer que les primaires d alimentation Cordon d alimentation secteur n est pas branch au cours de d sinfection NE PAS retirer les panneaux ou les couvertures de la V100 de tenter toute r paration Contact Emtek LLC ou de tout autre personnel de maintenance qualifi si les dysfonctionnements unit NE PAS immerger le V100 ou RCG dans tous les liquides PRENDRE TOUTES LES AUTRES MESURES DE SECURITE lectriques standard pendant le fonctionnement du RCG chantillonnage Assembl e avec le contr leur V100 Page 62 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual D 4 R2S Sampler Assembly Set Up and Testing NOTES Before sampling with the V100 and R2S e Perform the sanitization procedure in Appendix E e The V100 and R2S Air Sampler s must be calibrated as a system with the desired configuration This includes calibration of the V100 with either single or dual air sampling heads including the vacuum tubing length that will be employed during use 1 R2S Sampling Assembly Set Up and Testing 1 1 Attach the R2S power supply cable and vacuum supply tubing 1 1 1 Attach the R2S power supply cable and vacuum supply tubing as follows 1 1 1 2 Align the two keys of the cable connector with the key way Firmly press the
64. no image appears on the paper after a print command has been sent perform the described steps but check the orientation of the paper roll in the printer assembly Page 34 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 Fig 7 8 1 Printer Paper Label Installation V100 Controller and Air Sampler Users Manual 7 9 Replacing the HEPA Filter English DANGER Electric Shock or Electrocution Hazard exists Disconnect all power sources before repair or service to the instrument Francais DANGER Le Hasard d Electrocution ou de D charge lectrique existe D branchez toutes les sources de pouvoir avant la r paration ou le service l instrument English Important Note Take steps outlined in Step 4 2 to avoid ESD damage Francais Note Importante Voir la section 4 2 pour viter le dommage d ESD The V100 is equipped with a HEPA filter exhaust It is recommended to replace this filter every 6 to 12 months as part of periodic maintenance To replace the HEPA filter remove the filter door Fig 7 9 1 and 7 9 2 1 Release the filter from its connection port by gently pulling the filter straight out of the opening Fig 7 9 3 1 Once the filter is out of the unit carefully remove the flow control tubing Fig 7 9 3 2 Replace the new filter by first connecting the flow control tubing and gently pushing the filter onto its connection port A snug and complete fit is required
65. of 75 EMTEK V100 001vOI FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 1 6 Page 52 of 75 V100 Controller and Air Sampler Users Manual 1 5 10 If desired the test period can be paused resumed by pressing the pause resume key on the V100 or remote control at any time during the testing period Ending the Testing Period 1 6 1 When the set volume is achieved the blower and the plate rotation automatically stop If desired the test period can be terminated by pressing the Stop key on the V100 or on the remote 1 6 2 Remove the dome assembly retention clip and place on the edge of the blue dome seal 1 6 3 Aseptically remove the test plate from the turntable as follows Note Gloved hands should be rinsed with secondary disinfectant immediately prior to performing these steps 1 6 3 1 Remove the dome from the RCG sampler with one hand and with the other hand replace the lid of the test plate being careful not to touch the inside of the lid or the agar surface Do not move your hand over the exposed surface of the test plate Allow the lid to lead your hand over the test plate as you replace it 1 6 3 2 Remove the test plate with the lid in place from the turntable and place the dome back on the RCG sampler 1 6 3 3 Secure the lid to the test plate with tape 1 6 4 Upon completion of the test period a label is generated from the on board thermal label printer with the sample parameter information This
66. of air gas become impinged captured on the test plate within the RCG Dome assembly The sampled air volume is then drawn through the vacuum line into the vacuum inlet of the V100 and through the controller The sampled air volume passes through the system and is then exhausted from the V100 located outside of or away from the critical environment or test area through a 0 2 micron HEPA filter During testing the test plate rotates on the turntable This rotation removes recovered organisms from the direct path of incoming air to help prevent their desiccation allows for easier enumeration of isolates recovered and for the determination of the approximate time of their recovery Upon completion of the test period the test plate is removed from the RCG and is incubated for a designated time period at a specified temperature Following the required incubation period the numbers of bacterial Colony Forming Units CFU are enumerated for the sampled volume of air gas The density of air borne bacteria per volume of air gas tested can then determined using the provided formula Page 47 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual B 2 Materials e EMTEK RCG Confined Space Air Sampler and V100 Controller Calibrated for operation at 28 3 50 and or 100 LPM with power cable and vacuum tubing assembly e RCG Dome for 28 3 50 or 100 LPM Distance Indicator
67. of the facilities the entire assembly may be placed in a bag to minimize possible contamination of the unit 3 A cover e g sanitary cap or bioshield may be placed over the sample inlet cover of the RAS during transport and storage to minimize the potential of contamination 4 Store the V100 and RAS assemblies in a clean and dry place Page 59 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual Appendix D Remote Slit Sampler R2S Operation PURPOSE To describe the procedure to monitor for viable airborne bacteria with the Remote Slit Sampler Assembly R2S from EMTEK LLC D 1 R2S Operating Principles A 90 mm agar based test plate is placed on the turntable of the R2S underneath the dome assembly The required sample time period is set on the V100 Controller and the testing period is initiated During testing the V100 operates at a flow rate of either 28 3 LPM 50 LPM or 100 LPM as regulated by the setting on the V100 controller This sample volume passes into the R2S dome assembly through the sample chamber and sample slit Airborne bacteria in the sampled volume of air become impinged captured on the test plate within the R2S Dome assembly The sampled air volume is then drawn through the vacuum line into the vacuum inlet of the V100 and through the controller The sampled air volume passes through the system and is then exhausted fro
68. or for viable airborne bacteria on a Compressed Air Gas System with the Remote Compressed Gas RCG sampler from EMTEK LLC A 1 RCG Operating Principles The RCG compressed gas sample chamber is attached to a compressed gas drop through a short length of sample tubing and EMTEK s microbial high pressure diffuser with the aid of sanitary connectors gaskets and clamps A 90 mm agar based test plate is placed on the turntable of the RCG underneath the dome assembly and the dome assembly retention clip is put in place The required sample time period is set on the V100 Controller and the testing period is initiated With the EMTEK diffuser compressed air gas system may be tested at pressures ranging from approximately 15 115 PSI with the V100 using a flow rate of 50 LPM See EMTEK Microbial High Pressure Diffuser Procedure for diffuser use and maintenance The sample volume passes into EMTEK diffuser which steps down the pressure that then passes through the sample tubing and into the RCG dome assembly through the sample chamber and sample slit Airborne bacteria in the sampled volume of air gas become impinged captured on the test plate within the RCG Dome assembly The sampled air volume is then drawn through the vacuum line into the vacuum inlet of the V100 and through the controller The sampled air volume passes through the system and is then exhausted from the V100 located outside of or away from the critical environment or test area thro
69. owed to dry immediately prior to performing these steps 1 8 1 Remove the top sampling cover with one hand and with the other hand replace the lid of the test plate Be careful not to touch the inside of the lid or the agar surface Do not move your hand over the exposed surface of the test plate Allow the lid to lead your hand over the test plate as you replace it 1 8 2 Remove the test plate with the lid in place from the base plate holder and replace the top sampling cover 1 8 3 Secure the lid to the test plate with tape 1 8 4 Carefully inspect the test plate 1 8 4 1 Without taking the lid off the test plate assure that impingement marks are present on the agar surface 1 8 4 2 Ifimpingement marks are not present the sample test may be considered invalid NOTE Due to excessive moisture of a test plate impingement marks may be erased from the agar surface Ensure that plates with excessive moisture are not used to avoid this situation Page 58 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual 1 8 5 Assure all applicable information is recorded on the test plate as required Upon completion of the test period a printout label or Paper tape is generated from the on board thermal printer with the sample parameter information e g Sample Start Stop Time Site Date Operator Initials etc The paper can be retaine
70. pect the test plate 1 6 4 1 Without taking the lid off the test plate assure that impingement marks are present on the agar surface and that they are reflective of the sampling period EXAMPLE 1 The plate should make one full revolution if the sample completed its set time period and air impingement marks should be present around 355 of the plate A 5 buffer is present to determine the representative start and stop time EMTEK V100 001vOI FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 1 6 4 2 NOTE V100 Controller and Air Sampler Users Manual EXAMPLE 2 If the test period was stopped prior to its set time period the impingement marks should be visible around the corresponding time period as represented on the plate Half of the time period sampled would be indicative of almost half of the plate exhibiting impingement marks due to the 5 buffer If impingement marks are not present the sample test should be considered invalid unless impingement marks were noted during sampling Excessive moisture can cause issues with retaining the impingement marks see note below Due to excessive moisture of a test plate impingement marks may be erased from the agar surface Ensure that plates with excessive moisture are not used to avoid this situation 1 6 5 Assure all applicable information is recorded on the test plate e g Sample Start Stop Time Site Date Product informatio
71. per l alimentation de l instrument lors des branchements lectriques 4 2 Electrostatic discharge ESD considerations Page 15 of 75 Important Note To minimize hazards and ESD risks maintenance procedures not requiring power to the V100 should be performed with power removed Delicate internal electronic components can be damaged by static electricity resulting in degraded instrument performance or eventual failure Note Importante Pour minimiser les dangers et les risques de l EDD les proc dures d entretien non n cessitant une alimentation la V100 devrait tre ex cut avec la puissance retir s Interne sensible composants lectroniques peuvent tre endommag s par l lectricit statique r sultant en instrument une d gradation des performances ou de l chec ventuel EMTEK V100 001vOI FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual The manufacturer recommends taking the following steps to prevent ESD damage to your instrument e Before touching any instrument electronic components such as printed circuit cards and the components on them discharge static electricity from the body To discharge static electricity touch an earth grounded metal surface such as the chassis of an instrument or a metal conduit or pipe e To reduce static build up avoid excessive movement Transport static sensitive components in anti static container
72. permettrait au d sinfectant d tre entra n dans la pompe et de pr senter un danger lectrique Important Note Saturating the air passageway opening located beneath the R2S RCG turntable or in the RAS base would potentially allow the disinfectant to be drawn into the pump and damage it Note Importante Saturant l ouverture de passage d air situ sous le R2S RCG tourne disque ou dans la base de RAS permet ventuellement le d sinfectant d tre entra n dans la pompe et l endommager Page 68 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual 3 3 For initial cleaning each testing day the R2S RCG dome to base seal or the RAS base seal may be removed for sanitization Sanitize the surfaces of the seal with a wipe saturated with secondary disinfectant Alternatively the R2S RCG dome to base seal and RAS base seal may be autoclaved for each use 3 4 Interior Dome Assembly RAS Base Sanitization 3 4 1 The entire RAS sampler and the R2S RCG dome assembly may be autoclaved prior to each days testing if desired or chemical sanitized 3 4 2 With a new saturated wipe sanitize the interior surfaces of the sampler 3 4 3 For chemical sanitization of the R2S RCG dome assembly and interior of the RAS saturate a wipe with a primary disinfectant e g Quaternary Ammonium Compound and wipe all surfaces of the dome and sample chamber assembly
73. priate AC power source 110 240 VAC 50 60 Hz Turn the controller on using the power switch on the back panel of the V100 Fig 5 2 1 9 5 Set required parameters using the touch screen interface Section 7 2 If a label paper output is desired ensure that the printer is turned on Fig 7 2 4 8 and that the unit has and adequate supply of paper labels Section 7 5 7 Follow the appropriate procedure to collect the required samples See appendices for operating instructions for each sampler Page 20 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 Section 7 Operating Instructions V100 Controller and Air Sampler Users Manual 7 1 Touch Screen Test Sample Screen 91 02 2010 State Test Mi Test 00 03 05 01 05 19 PM 3 PLATE ROTATION Flow Rate LPM bet 28 3 Actual 28 3 est Volume Liters Set 283 0 Total 54 8 Sample Time HH MM S Set 00 10 00 j Elapsed 00 01 55 ABEL FEED 4 e A 4 cy Q o Ay is a tanao Q Test 00 05 00 Hold 00 05 00 Fig 7 1 1 Touch Screen User Interface UI Test Sample Screen Table 7 1 1 Items on Test Sample Screen Type Name Description CURRENT DATE 1 Displays date set by user Sampler Indicator SAMPLER 1 Displays sampler type selected by user IDENTIFICATION CURRENT TIME 1 Displays time set by user l Sample Test Information Function Keys Sample Progress Indicator Page 21 of 75 EMTEK
74. propriate 4 Following the required incubation period count all Colony Forming Units CFU found within the air impingement zone 5 Determine Total CFU Specified Volume and record the results in the appropriate section of the electronic or hard copy test report form This result is calculated as follows Total CFU per Test Plate CFU Identified Volume L ft m Volume Sampled EXAMPLE If the test period was set to sample at 100 LPM for 10 minutes the total volume collected would be 1000 Liters L or 1 cubic meter m If following incubation 20 CFU were recovered in the impingement zone of the plate The calculation would be e Total CFU Test Plate 20 e Total Volume 1000 L or 1 m 20 CFU Test Plate 20 CFU 0 02 CFU L or 20 CFU m 1000 L or 1 m 1000 L or 1 m 6 Record date Off Test in the appropriate section of the test report form 7 If Microbial Identification of organism recovered is required submit plate for ID according to applicable procedures related for sample submission and processing for Microbial Identification Discard all other plates in an appropriate Bio Hazard container for disposal 8 Test Report Forms once completed should be reviewed for accuracy and completeness and signed by a second qualified analyst Page 70 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Man
75. r R2S Operation s essssssessssecccssecosseccssscccsssecosscecossecocsssesssescossecossessesssseesssse 60 DI R25 Oprane Pinciples ne nt ea TE AAEE 60 D E E E 6l D3 Mamnenance Ts D6 CUO ere E A aE R i 62 D 4 R2S Sampler Assembly Set Up and Testing 63 D gt SIDE And TTAN PO a de nd dun 66 Suggested Sampler SamitatiOn secssscacssasessscaccsnsacesaisencanesascoaeandavanceasesneseauessassscodacasusaseoiseasenssioesasasates 67 EL Ma e A es A E O 67 P2 pan Zao POCE E ees E E NE 67 Suggested Sample Submission and Results Recording ccccccccssssssccccssssssccccccesssscsccseeeeees 70 CE Declaration Of CONIOFMICY sssisicesesesstcecasrcavsecsccbeaseacebinassenssvebscsesadavcenessaseasancacesscoasesaassascisoaessancons 71 VAR ANY EE ER 72 Packing Materials and Packaging of Components ccccssssssccccrcscssccccccsssscccccccesssssccceeeesscceees 73 EMTEK V100 001vOI FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual Section 1 Specifications V100 Air Sampler Controller Motor Type Blower Motor Display Color 4 VGA TFT LCD touch screen Interface Windows CE based Sample Time Volume Variable User Defined Maximums 60 minutes 1700 Liters 28 3 LPM 40 min 2000L 50 LPM and 20 min 2000L 100 LPM software allows for 240 min 6800L Delay Hold Times Variable User Defined Sample Flow Rates 28 3 50 or 100 liters per minute LPM 1
76. r Sampler Controller R2S Remote Slit Sampler RCG Remote Compressed Gas Confined Space Sampler RAS Remote Autoclavable Sampler E 1 Materials Gloves Sterile or Clean Low Particulate Shedding Wipes e g Wipe All Gamma Wipes Primary Disinfectants e g Quaternary Ammonium Compounds Important Note Phenolic disinfectants should not be used on the Clear Dome Assembly as it will cause the dome to become very brittle in a short period of use Secondary Disinfectants e g 70 0 2um filtered or sterilized alcohol E 2 Sanitization Procedure l Don a pair of clean or sterile gloves Note Gloved hands should be sanitized with a disinfectant e g 70 alcohol throughout this procedure English DANGER TO MINIMIZE THE CHANCE OF ELECTRIC SHOCK disconnect the V100 primary AC power supply cord during sanitization DANGER DO NOT SUBMERSE the V100 controller or sampler in any liquids Fran ais DANGER pour minimiser le risque d lectrocution V100 primaires d connectez le cordon d alimentation AC au cours de d sinfection DANGER NE PAS immerger le contr leur de V100 ou de l chantillonneur dans tous les liquides Page 67 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual 2 V100 Sanitization 2 1 To sanitize the V100 Controller sanitize the exterior of the sampler vacuum tubing power supply cable IR Remote
77. retention clip from the top of the dome assembly and place it on the edge of the dome seal 10 2 Aseptically place the test plate e g 90 mm TSA plate on the turntable as follows NOTE Gloved hands should be cleaned with secondary disinfectant immediately prior to performing these Steps Page 43 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual 10 3 Lift up the dome assembly just high enough to place the test plate on the turntable and remove its lid Without inverting place the lid of the test plate face down on a pre sanitized surface NOTE Removing and holding the dome only a few inches directly over the turntable will minimize the chance of contaminants settling on the sanitized components under the dome and on the test plate during this manipulation 10 4 Place the dome assembly down over the test plate and turntable 10 5 Securely seat the dome assembly in the dome to base seal and assure that the dome is properly seated in the seal 10 6 Replace the dome assembly retention clip 10 7 Adjust the Turntable Test Plate Height Adjustment as follows 10 7 1 View the test plate distance indicator through the side of the dome to assure that test plate is at the proper height 10 7 2 Rotate the turntable adjustment knob clockwise or counter clockwise until the top of the test plate just touches the distance indicator on
78. s Liters EH SCREEN EXIT SETUP Sample Rate LPM 28 3 Sample Volume Liters 56 6 ii i a PREVIOUS j Sample Time 00 02 00 Wee Set Delay 00 00 00 A Test Hold Test 00 00 00 s E Hold 00 00 00 Fig 7 2 2 Setup Screen 2 Sample and Test Information Table 7 2 2 Items on Setup Screen 2 Parameter SAMPLE SITE Used to input sample and or site identifier DESC Keys CURRENT Indicates sampling head in use R2S RAS or RCG DEVICE UNITS Select units Liters Cubic Feet Cubic Meters SAMPLE Select sample flow rate 28 3 50 or 100 LPM RATE 1 1 766 or 3 531 CFM 0 0283 0 05 0 1 CM SAMPLE Selects a specified total sample volume to be collected VOLUME Based upon the selected sample rate setting a specific sample volume changes the SAMPLE TIME required The maximum volume is 2000 liters 79 7 cubic feet 2 cubic meters Larger total volumes are possible at the 28 3 LPM sampling rate SAMPLE TIME Set desired sample time Based upon the selected flow rate setting a specific time changes the SAMPLE VOLUME SET DELAY Set an initial delay period prior to initiating the sample period OPTIONAL TEST HOLD Set a specified test period and a specified hold of the test period OPTIONAL Note For Index 1 3 descriptions see Table 7 2 1 Page 23 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Man
79. s or packaging e To discharge static electricity from the body and keep it discharged wear a wrist strap connected by a wire to earth ground e Handle all static sensitive components in a static safe area If possible use anti static floor pads and work bench pads Page 16 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual 4 3 Electrical Data Connections English DANGER Electric shock hazard Always disconnect power to the instrument when making electrical connections Francais DANGER Un choc lectrique risque Toujours couper l alimentation de l instrument lors des branchements lectriques Connect external power plug 4 air sampler electrical connection 1 USB cable 2 or Ethernet cable 3 to the V100 to enable functionality or to download data Make connections where indicated Figure 4 3 1 ie Le a 4 Page 17 of 75 EMTEK V100 001v01 FEB2011 Fig 4 3 1 V100 Rear View Air Sampler RCG R2S Electrical Connector Ethernet Port USB Port Primary Power Inlet Power Switch V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual Section 5 V100 Description 5 1 V100 Front View Fig 5 1 1 V100 Front View l Sampler Transport Cup 2 Retractable Extendable Transport Handle 3 IR Remote Receiving Sensor 4 Thermal Label Paper Printer 5
80. sample tubing assembly attaching the RCG to the diffuser and the diffuser may be autoclaved or chemically sanitized before or after each use It is ideal to package and store the assembly to minimize the contaminant load Autoclave pouches may be used for this purpose See EMTEK Microbial High Pressure Diffuser Procedure Page 46 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual Appendix B Remote Compressed Gas Confined Space RCG Sampler Operation for Confined Spaces This section describes the procedure to monitor for viable airborne bacteria in a Confined Space with the Remote Compressed Gas Confined Space RCG sampler from EMTEK LLC B 1 RCG Operating Principles The RCG Confined Space sampling head 1s attached to a critical zone or location using a short length of sample tubing with sanitary connectors or barbed fittings A 90 mm agar based test plate is placed on the turntable of the RCG underneath the dome assembly and the dome assembly retention clip is put in place The required sample time period is set on the V100 Controller and the testing period is initiated During testing of the critical zone the V100 operates at a flow rate of 28 3 50 and 100 LPM as regulated by the V100 controller This sample volume passes into the RCG dome assembly through the sample chamber and sample slit Airborne bacteria in the sampled volume
81. ssure it is not visibly damaged in a way that would keep it from sealing appropriately tears in the seal etc e The sample inlets shall be visually inspected to assure that they are free of occlusions to assure proper sample flow If any maintenance need be performed contact appropriate service or repair personnel IMPORTANT SAFETY PRECAUTIONS English TO MINIMIZE THE CHANCE OF ELECTRICAL HAZARD assure that the primary AC power supply cord is not plugged in during sanitization DO NOT REMOVE THE PANELS or COVERS of the V100 to attempt any repairs Contact EMTEK LLC or other qualified service personnel if the unit malfunctions DO NOT SUBMERSE the V100 or RCG in any liquids Page 55 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual TAKE ALL OTHER STANDARD ELECTRICAL SAFETY PRECAUTIONS when operating the RCG Sampling Assembly with the V100 controller Francais Pour minimiser le risque DE DANGER ELECTRIQUE s assurer que les primaires d alimentation Cordon d alimentation secteur n est pas branch au cours de d sinfection NE PAS retirer les panneaux ou les couvertures de la V100 de tenter toute r paration Contact Emtek LLC ou de tout autre personnel de maintenance qualifi si les dysfonctionnements unit NE PAS immerger le V100 ou RCG dans tous les liquides PRENDRE TOUTES LES AUTRES MESURES DE SECURITE lectriques s
82. t the bottom back corner of the V100 controller unit 1 4 3 If the RAS has been chemically sanitized ensure residual disinfectant and particulate matter from cleaning and set up are removed from the sample chamber by purging the unit prior to initiating testing 1 4 3 1 Set the sample parameters on the V100 to sample for 2 3 minutes see Section 7 1 4 3 2 Press the Start key on the V100 to start the blower motor 1 4 3 3 Once the blower ramps up to the appropriate flow rate approx 2 5 seconds sampling on the V100 will begin 1 4 3 4 The V100 will stop once the selected sample volume is attained 1 4 3 5 Check to ensure that the RAS is physically dry Repeat steps 1 4 3 2 through 1 4 3 4 as necessary until visibly dry 1 5 Begin testing by following the steps below 1 5 1 Set the sample parameters on the V100 to sample for the desired flow rate and sample volume sample time etc see Section 7 NOTE An initial sample delay can be set to allow for clearance of the area by personnel prior to the start of sampling A test hold function is also available as well as IR remote control see Section 7 1 5 2 Aseptically place the test plate 1 e 90 mm TSA plate on the turntable as follows NOTE Gloved hands should be cleaned with secondary disinfectant and allowed to dry immediately prior to performing these steps 1 5 3 Lift up the top sampling cover just high enough to place the test plate on the turntable and remove its lid
83. tandard pendant le fonctionnement du RCG chantillonnage Assembl e avec le contr leur V100 C 4 RAS Sampler Assembly Set Up and Testing NOTES Before sampling with the V100 and RAS e Perform the sanitization procedure in Appendix E e The V100 and RAS Air Sampler s must be calibrated as a system with the desired configuration This includes calibration with either single or dual air sampling heads including the vacuum tubing length that will be employed during use 1 RAS Sampling Assembly Set Up and Testing 1 1 Attach the RAS Vacuum Supply Tubing for single or dual head operations see Section 7 5 images 1 1 1 Attach one end of the vacuum tubing to the vacuum tube connection on the V100 1 1 2 Attach the other end of the vacuum tubing to the barb on the RAS Sampler 1 2 Upon completion of sanitization per Appendix E If applicable place the RAS at the desired test site 1 3 Place the V100 outside or below 1 e on a cart the testing area within the constraints of the power supply cord and vacuum supply line NOTE Contact EMTEK LLC for additional information on the maximum length of the vacuum supply line allowable 1 4 Initiate unit power as follows 1 4 1 Plug the Primary AC Power Supply Cord into an appropriate power outlet Page 56 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual 1 4 2 Turn on the unit power switch found a
84. technology components software and firmware become available EMTEK LLC reserves the right to make changes to any products herein at any time without notice In some instances photographs and figures are of equipment prototypes Therefore before using this document consult your EMTEK LLC representative for information that is applicable and current The information in this manual is believed to be accurate However EMTEK LLC assumes no responsibility for any inaccuracies that may be contained in this manual In no event will EMTEK LLC be liable for direct indirect special incidental or consequential damages resulting from any defect or omission in this manual even if advised of the possibility of such damages In the interest of continued product development EMTEK LLC reserves the right to make improvements in this manual and the products it describes at any time without notice or obligation No part of the contents of this manual may be reproduced or transmitted in any form or by any means without the written permission of EMTEK LLC 2 5 License Restriction The purchase or use of an EMTEK LLC product does not convey a license under any patent copyright trademark or other intellectual property right of EMTEK LLC or third parties Page 5 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual 2 6 V100 Technical Description The V100 EMTEK
85. the interior center of the dome This adjustment will assure the required distance of approximately 2 3 mm from the test plate surface to the opening of the sample slit 10 7 3 Starting the Testing Period 10 7 3 1 Assure that the sample time is set to the desired sample period and the drop is 10 7 3 2 10 7 3 3 regulated to the predetermined rate then slowly open the flow on the compressed air gas drop and press the Start button on the V100 or remote to begin the test cycle Assure that the sampling assembly is not over or under pressurized Air will be noted to escape from the base of the clear dome assembly if the system pressure is too high and or the Actual Flow indicator on the V100 will register higher than the selected In addition high and low flow alarms can be set by the user to alert if the condition exists See Section 7 If desired the test period can be paused resumed by pressing the pause resume key on the V100 or remote control at any time during the testing period 10 7 4 Ending the Testing Period 10 7 4 1 When the selected volume is achieved the blower and the plate rotation Page 44 of 75 EMTEK V100 001v01 FEB2011 automatically stop If desired the test period can be terminated by pressing the Stop key on the V100 or remote V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 10 7 4 2 V100 Controller and Air Sampler Users Manual Immediately turn off the compressed air gas supply
86. throat shall be visually inspected to assure that it is free of occlusions to assure proper sample flow through the slit If any maintenance need be performed contact appropriate service or repair personnel IMPORTANT SAFETY PRECAUTIONS English TO MINIMIZE THE CHANCE OF ELECTRICAL HAZARD assure that the primary AC power supply cord is not plugged in during sanitization DO NOT REMOVE THE PANELS or COVERS of the V100 to attempt any repairs Contact EMTEK LLC or other qualified service personnel if the unit malfunctions DO NOT SUBMERSE the V100 or RCG in any liquids TAKE ALL OTHER STANDARD ELECTRICAL SAFETY PRECAUTIONS when operating the RCG Sampling Assembly with the V100 controller Francais Pour minimiser le risque DE DANGER LECTRIQUE s assurer que les primaires d alimentation Cordon d alimentation secteur n est pas branch au cours de d sinfection NE PAS retirer les panneaux ou les couvertures de la V100 de tenter toute r paration Contact Emtek LLC ou de tout autre personnel de maintenance qualifi si les dysfonctionnements unit NE PAS immerger le V100 ou RCG dans tous les liquides PRENDRE TOUTES LES AUTRES MESURES DE SECURITE lectriques standard pendant le fonctionnement du RCG chantillonnage Assembl e avec le contr leur V100 Page 49 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 B 4 V100 Controller and Air Sampler Users Manual RCG
87. tion clip is intended to retain the dome in place curing set up and purging while allowing excess pressure to escape between the dome flange and seal 6 Run air gas through the unit for approximately 2 3 minutes or until physically dry within the RCG dome assembly and then turn off the air gas supply 7 Turn on the V100 power switch at the bottom back corner of the unit 8 Set the desired sample parameters on the V100 see Section 7 9 Verifying the flow rate to the desired flow 50 or 100 LPM for compressed air gas sampling 9 1 Slowly open the compressed air gas drop regulated to 15 115 PSI and then press the Start key on the V100 or remote to start the blower 9 2 Once the blower ramps up to the appropriate flow rate approximately 2 to 5 seconds sampling on the V100 will begin 9 3 Ensure that the flow on the compressed air gas drop is achieving the required airflow on the V100 controller NOTE Over pressurization of the drop will be evident by a higher registered flow rate than that set Under pressurization will be evident by a lower registered flow rate than that set In addition low and high flow alarms can be set to alert the user of these conditions see Section 7 9 4 Once the set volume is achieved the blower motor will stop To stop the unit sooner press the Stop key on the V100 or remote to stop the unit and turn off the flow from the compressed air gas drop 10 Initiating Sampling 10 1 Remove the
88. tized surface NOTE Removing and holding the dome only a few inches directly over the turntable will minimize the chance of contaminants settling on the sanitized components under the dome and on the test plate during this manipulation Place the dome assembly down over the test plate and turntable Securely seat the dome assembly in the dome to base seal and assure that the dome is properly seated in the seal Adjust the Turntable Test Plate Height Adjustment as follows 1 5 6 1 View the test plate distance indicator through the side of the dome to assure that test plate is at the proper height 1 5 6 2 Rotate the turntable adjustment knob clockwise or counter clockwise until the top of the test plate moves to just touch the distance indicator pin This adjustment will assure the required distance of approximately 2 3 mm from the test plate surface to the opening of the sample slit EMTEK V100 001vOI FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual Press the Start button on the V100 or remote control to begin the test cycle If desired the test period can be paused resumed by pressing the pause resume key on the V100 or remote control at any time during the testing period 1 6 Ending the Testing Period 1 6 1 Page 65 of 75 When the timer counts down from the set time period or the required volume is attained the blower and the plate rotatio
89. ual Appendix 1 CE Declaration of Conformity Declaration of Conformity The Manufacturer of the Products covered by this Declaration is EMI CIE MICROBIAL AIR SAMPLERS EMTEK LLC located at 1430 Nelson Rd Suite 210A Longmont CO 80501 The Directives covered by this Declaration 2004 108 EC Electromagnetic Compatibility Directive EMC 2006 95 EC Low Voltage Directive LVD The Products Covered by this Declaration V100 Air Sampler Controller Model number 001 Serial Numbers 00001 99999 The Basis on which Conformity is being Declared The manufacturer hereby declares under his sole responsibility that the products identified above comply with the protection requirements of the EMC directive and with the principal elements of the safety objectives of the LVD directive and that the following standards have been applied CENELEC EN 61010 1 BEI Safety Requirements for Electrical Equipment for Measurement Control and Laboratory Use Part 1 General Requirements Issued 2001 03 01 BSI BS EN 61326 1 BEI Electrical equipment for measurement control and laboratory use EMC requirements Part 1 General requirements 1998 Issued 2006 06 30 UL 61010 1 EEI UL Standard for Safety Electrical Equipment For Measurement Control and Laboratory Use Part 1 General Requirements Issued 2004 07 12 Ed 2 Rev 2008 10 28 CAN CSAC22 2 61010 1 AEI Standard for Safety Electrical Equipment For Measurement Control and Laboratory Use Part 1
90. ual Setup Screen 2 2 1 i Set Time Format Sleueele 7 Set Date Format MM DD YY i Set Time 06 22 58 AM i 3 Set Date 01 02 2010 i Alarm Level Flow Alarm Fig 7 2 3 Setup Screen 3 Time Date and Alarm Information Table 7 2 3 Items on Setup Screen 3 Parameter SET TIME Select the time format Military or Standard FORMAT Keys SET DATE Select the date format MM DD YY DD MM YY FORMAT Sets the current time SET TIME Sets the current date SET DATE Select to adjust speaker volume ALARM LEVEL Select to turn flow alarm on off FLOW ALARM Select to set low flow alarm from set flow LOW Select to set high flow alarm from set flow HIGH Note For Index 1 3 descriptions see Table 7 2 1 Page 24 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 Parameter Keys Parameter Keys Page 25 of 75 EMTEK V100 001v01 FEB2011 V100 Controller and Air Sampler Users Manual Setup Screen 4 2 IR Remote 8 i IR ID i Printer F SCREEN PRG Type ELLE LLLELEELEELEECLEEE 568 munmnnnnnns if Replicates fi anO REPRINT Time Date Rangi i 9 eS Last Samples 2 x B i Date Range 02 03 2010 To 02 CO han ET SEMT EK Sanno Fig 7 2 4 Screen 4 IR Remote Printer Function and Reprint Settings Table 7 2 4 Items on Setup Screen 4 IR REMOTE Turns the IR remote function ON and OFF IR ID Sets the units IR ID
91. ugh a 0 2 micron HEPA filter During testing the test plate rotates on the turntable This rotation removes recovered organisms from the direct path of incoming air to help prevent their desiccation allows for easier enumeration of isolates recovered and for the determination of the approximate time of their recovery Upon completion of the test period the test plate is removed from the RCG and is incubated for a designated time period at a specified temperature Following the required incubation period the numbers of bacterial Colony Forming Units CFU are enumerated for the sampled volume of air gas The density of air borne bacteria per volume of air gas tested can then determined Page 39 of 75 EMTEK V100 001v01 FEB2011 V100 Model V100 001 SFTWRE 2 76 2 79 FRMWRE 1 59 1 63 V100 Controller and Air Sampler Users Manual A 2 Materials e EMTEK RCG Compressed Air Sampler and V100 calibrated for operation at 50 LPM with power cable vacuum tubing assembly e 50 LPM RCG Dome Assembly with Green Distance Indicator Mount for 50 LPM 50 LPM RCG Dome Green e EMTEK Microbial High Pressure Diffuser Sanitary sample tubing assembly and sanitary fitting clamps single or multiple autoclaved or chemically sanitized for use e Gloves Sterile or Clean Standard 90 mm agar test plates e g TSA Agar e Incubator s e g 30 35 C or 20 25 C e Low Particulate Shedding Wipes e g Wipe All Gamma Wipes or equivalent or b

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