FCC ID: 2AV6V-M110 BioAerosol Monitoring System

BioAerosol Monitoring System | BAMS User Manual Version: 1.2.1 Mar 2020 Doc No. YM1108112 Disclaimer 1. This instrument must be operated by trained laboratory personnel only. 2. Please power off the instrument when an exception occurs. 3. Read all instructions in this user manual carefully before unpacking and operating the instrument. The MICRON VIEW LIMITED is not liable for any responsibility of system malfunction and its safety and effectiveness caused by violating the above disclaimer. Content CHAPTER 1 INTRODUCTION ........................................................................................................................................ 1 1.1 OVERVIEW.................................................................................................................................................................... 1 1.2 NOTES ......................................................................................................................................................................... 1 1.3 FCC PART 15 INSTRUCTION .......................................................................................................................................... 2 CHAPTER2 SPECIFICATIONS ......................................................................................................................................... 3 2.1 PARTS LIST .................................................................................................................................................................... 3 2.2 TECHNICAL SPECIFICATION ............................................................................................................................................... 4 CHAPTER3 SAFETY INSTRUCTIONS .............................................................................................................................. 6 3.1 INSTALLATION ................................................................................................................................................................ 6 3.2 POWER SUPPLY .............................................................................................................................................................. 6 3.3 OPERATION .................................................................................................................................................................. 6 3.4 MAINTENANCE AND INSPECTION ....................................................................................................................................... 7 CHAPTER4 INSTALLATION ........................................................................................................................................... 8 4.1 BATTERY INSTALLATION .................................................................................................................................................... 8 4.2 ISOKINETIC PROBE INSTALLATION ....................................................................................................................................... 8 4.3 COMMUNICATION INTERFACE ........................................................................................................................................... 9 CHAPTER5 OPERATION ..............................................................................................................................................10 5.1 STARTUP .................................................................................................................................................................... 10 5.2 FUNCTION KEYPAD ....................................................................................................................................................... 10 5.3 SETTING ..................................................................................................................................................................... 11 5.3.1 Zone ................................................................................................................................................................. 12 5.3.2 Sampling SCM .................................................................................................................................................. 14 5.3.3 Data SCM ......................................................................................................................................................... 15 5.3.4 Display ............................................................................................................................................................. 16 5.3.5 Time ................................................................................................................................................................. 17 5.3.6 Info Alert .......................................................................................................................................................... 17 5.3.7 Audit Trail ........................................................................................................................................................ 17 5.3.8 Device .............................................................................................................................................................. 18 5.3.9 Operator .......................................................................................................................................................... 19 5.3.10 WIFI ............................................................................................................................................................... 20 5.3.11 MV Connect ................................................................................................................................................... 21 5.4 SAMPLING .................................................................................................................................................................. 22 5.5 DATA ......................................................................................................................................................................... 24 5.6 SHUTDOWN ................................................................................................................................................................ 27 CHAPTER 6 PRINTER ..................................................................................................................................................29 6.1 EXTERNAL DIMENSIONS ................................................................................................................................................ 29 6.2 OPERATING PROCEDURE................................................................................................................................................ 29 6.3 INSTALL PAPER ROLL ...................................................................................................................................................... 29 6.4 SPECIFICATIONS ........................................................................................................................................................... 29 CHAPTER 7 TROUBLESHOOTING AND MAINTENANCE ...............................................................................................31 7.1 TROUBLESHOOTING ...................................................................................................................................................... 31 7.2 MAINTENANCE ............................................................................................................................................................ 33 7.3 RETURN FOR SERVICE ................................................................................................................................................... 34 CHAPTER 8 WARRANTY .............................................................................................................................................35 Chapter 1 Introduction 1.1 Overview The BioAerosol Monitoring System (BAMS) is used to detect both inert and microbial particles in real-time, primarily in clean room environments. It is appropriate for use across many industries, such as aerospace, biopharmaceutical, medicine & health, electronics, food, and optics. Its main applications are clean class classification, clean room validation, contaminant source tracking, indoor-air quality monitoring, contaminant trend analysis, etc. The instrument provides the real-time feedback of air quality in clean rooms by monitoring both inert and microbial particles and can run 24x7. Contaminants can therefore be found early because of the continuous and real-time monitoring. BAMS saves users time and enables more immediate action and resolution. Without traditional culturing methodology and consumables, BAMS helps reduce both costs and reaction times. General BAMS characteristics and specifications Particluate size ranges measured: 0.5m to 25.0m Simultaneous detection of 6 channels Inert and microbial particle counts in real-time, without cultivation 24x7 continuous monitoring On-screen, real-time data curves Easy data review and printing Reporting standards: ISO/EUGMP/CHINESEGMP/Fed Std Minimalism design, weighing only 12.8lbs (5.8Kg) 1.2 Notes power grid does not meet the requirements. 2. The device should be stored away from direct sunlight. 3. Do not allow corrosive gases, fume and liquid into the inlet. 4. Make sure the sample tubing is free from obstruction when connecting. 5. Only use in clean room environments to avoid inner contamination. 1. The power supply requires AC 100-240V, 50/60Hz. The regulated power supply is recommended if the local 6. BAMS and the inlet must be placed in the same pressure, temperature and humidity. 7. The USB flash drive is only used for system software upgrade and storage of BAMS technical documents. We recommend that it is not for any other use. 8. If not installed and used in accordance with the instructions, may cause harmful interference to radio communications. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, or remove the equipment to the other place. 1 1.3 FCC Part 15 Instruction NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Any changes or modifications not expressly approved by the party responsible for compliance could void the users authority to operate the equipment. The product model and approval code are displayed on the back of the device by laser engraving. Produce name: BioAerosol Monitoring System Model: M110 Manufacturer: Micron View Limited Address: Suite 1, 3rd Floor,11-12 St. James's Square, London, SW1Y 4LB, United Kingdom 2 Chapter2 Specifications 2.1 Parts List 1. BioAerosol Monitoring System (BAMS) Part No: MACHM110 2. Isokinetic probe Part No: J26A020004a 3. Adapter for filter Part No: J05A020008a 4. HEPA filter Part No: W0204000001 5. AC adapter Part No: BD14010002 6. Power cord Part No: XA1106081(CN), XA1106082(EU), XA1106083(US) 7. Sample tubing (3 meters) Part No: W0302000002 8.Rechargeable lithium battery Part No: BD14020004 9. USB flash drive (include User Manual) Part No: BD17030001 10. Carry case Part No: W0701050001 11. Documents: a. Quick start guide, b. Certificate of calibration 3 2.2 Technical specification Specification BioAerosol Monitoring System Size range 0.5m - 25m Size channels 0.5m, 1.0m, 2.0m, 3.0m, 5.0m, 10.0m Laser source Long life laser Size resolution

<15% @ 0.5m (meets ISO 21501-4) Flow rate 5LPM3%

Flow rate control Electronic, automatic closed-loop Zone/Location 20,000 rooms and 200,000 locations Sampling time 0.1 seconds to 999 hours 59 minutes 59 seconds Delay Cycles Interval 0-99 hours 59 minutes 59 seconds 1000 samples on one location 0-99 hours 59 minutes 59 seconds Count efficiency 50% 20% for 0.5m, 100% 10% for >0.75m (meets ISO 21501-4 and JIS B9921) Sampling mode Manual, auto, beep, cumulative count / differential count or concentration Zero count

<1count/5min Concentration limit 4,000,000 particles/ftat 10% coincidence loss Exhaust Display Internal HEPA filter (>99.997%@0.3m) 8 LCD capacitive touch screen Language Chinese, English Communication RJ45, USB, SENSER-HUB, WIFI Capture the biological Contamination sample Connect the BioAerosol Sampler (BAS) via WIFI/USB to collect the biological contamination sample in real time Reports Export file Compliant with ISO/EUGMP/CHINESEGMP/Fed Std PDF file or EXCEL file Data storage 119G Data security Authority management, authority level divide into admin, operator and supervisor Data reliability Compliant with 21 CFR Part 11 Print Auto or Off-line 4 Alarm Audible built-in alarm Calibration frequency Recommend once a year Dimensions (HxWxD) 10x7.87x10.39 in/255x200x264mm (with handle and foot mat) Weight Enclosure Power Battery Safety 12.8lbs/5.8Kg (without battery) 316L Stainless Steel and anodized aluminum AC 100-240V, 50 Hz/60 Hz 10.8V, 9Ah, rechargeable lithium battery Power consumption AC 32W Operating conditions Storage conditions Temperature: 5C -35 C / 41F - 95F Relative humidity: 5-90% non-condensing Temperature: 0C -40 C / 32F - 104F Relative humidity: 5-90% non-condensing EN 61010-1:2010, EN 61326-1:2013, EN 61326-2:2:2013, EN 60825-1:2014, EN 61000-6-1:2007, EN 61000-6-3:2007+A1, FCC Part 15, Subpart B, EN 300 328 V2.1.1: 2016, ETSI EN 301 489-1 V2.2.0: 2017, ETSI EN 301 489-17 V3.2.0: 2017, EN 62311:2008, EN 62479: 2010 Warranty One year after activation 5 Chapter3 Safety Instructions 3.1 Installation Caution Do not use the device near ethyl alcohol, paint thinners or any other inflammable materials. If inflammable materials come into contact with the electrical components inside the device, it could be a fire hazard. Do not place any containers with water or liquid on the device. Shut down the device immediately when any liquid falls into or splashes into the device. In addition, if the power cord or any cables are connected, disconnect immediately. Unplug the power cord entirely. Do not place the device on an unstable location (such as an unstable platform or sloped surface). Do not place the device where is vulnerable to severe vibration. Any of these conditions can result in damage to the device or personal injury for those nearby. The rear exhaust ensures the proper gas path function. Blockage the exhaust could cause overheating and malfunction, potentially creating a fire hazard. Do not place the device on the following location, or it could be a fire hazard. Direct sunlight Locations susceptible to high temperatures. Close to any open flame. 3.2 Power supply Caution Do not disassemble or modify the cable. Do not place the heavy objects on the cable. Keep the cable away from heat source. Otherwise, the insulating layer of the cord may melt and could be an electric shock hazard or a fire hazard. Do not stretch the cable, or it may become loose, overheating and could be a fire hazard. The cable may be damaged if it is placed under strain. Using a damaged cable may result in accidents such as fire or electric shock. Do not handle the power cord or cable with wet hands, or it could be an electric shock hazard. Do not place any items on the AC adapter. It could cause overheating and result in fire or electric shock. Do not use an AC adapter that is not supplied by MicronView, or it could be a fire hazard. Do not use the supply voltage out of range of AC adapter, or it could be a fire hazard or an electric shock hazard. To unplug, always grasp the power cord. Do not stretch the cable, as it may expose the core of the cable or damage the insulation. It may result in electric leakage, and it could be a fire hazard or an electric shock hazard. 3.3 Operation Do not disassemble or modify the device. Exposure to the high temperature parts, mechanical parts and laser inside the device could result in personal injuries such as burns, blindness, etc. Caution 6 If abnormal noise, fume, overheat or strange odors are detected, shut down the device and disconnect the attached cords or cables immediately. Contact the local distributor. If continue to use, it may result in fire. Do not use the inflammable spray near the device. If the inflammable materials contact the electrical components, it may result in a fire hazard or electric shock hazard. 3.4 Maintenance and Inspection Caution Use only MICRONVIEW-supplied battery when the battery needs replacement. Shut down the device and disconnect the attaching plug to avoid the electric shock. To avoid fierce collision and keep from source of heat, or it could be a fire hazard or an explosion hazard. Wet the clean wiper with 70-80% ethyl alcohol or isopropyl alcohol and clean the device surface. Do not allow the ethyl alcohol or isopropyl alcohol to have contact the electrical components inside the device, or it may result in malfunction. 7 Chapter4 Installation External view of BAMS. Sample inlet Battery cabin Power button Exhaust Port panel 4.1 Battery installation

(1) Remove the battery cover at the rear of the device and insert the battery (note the installation direction). See chart 4-1.

(2) Close the battery cover. Chart 4-1 Battery installation 4.2 Isokinetic probe installation

(1) Connect the isokinetic probe and sample inlet with a sample tubing. See chart 4-2.

(2) Fix the isokinetic probe on the adjustable tripod mount (optional), and connect the isokinetic probe and sample inlet with a sample tubing. Chart 4-2 Isokinetic probe installation 8 4.3 Communication interface The applications of interfaces on the back of the device are described as blow. Title Description TEST For calibration SENSER HUB External sensor, beep sensor controller and other communication application RJ45 USB A Network connection For data export and software upgrade POWER 24V AC adapter input 9 Chapter5 Operation 5.1 Startup Press the power button in the lower-right corner of the front of the device. The white indicator lights up to indicate the device is switched on and the login interface appears. See chart 5-1-1. Input the username and password to enter the sampling interface. (The factory default username is ADMIN, and password is 0.) There are three functional tabs on the bottom of the screen: data, sampling and setting, respectively. Touch any tab to enter the corresponding functional interface. See chart 5-1-2. If ADMIN password is forgotten, please contact us to retrieve the password byForgot your passwordicon. Chart 5-1-1 Login Chart 5-1-2 Functional tabs 5.2 Function keypad Touch an input area to activate the soft keyboard. TouchOKicon and the soft keyboard will be hidden. See chart 5-2-1. Chart 5-2-1 Soft keyboard When inputting the time, the time keyboard will be activated. Select the number via the up arrow/down arrow, or directly input the number with the number keyboard on the right side. TouchOKicon and the number keyboard will be hidden. See chart 5-2-2. 10 The function and interface of the date keyboard are similar to the time keyboard. See chart 5-2-3. Chart 5-2-2 Time keyboard Chart 5-2-3 Date keyboard 5.3 Setting Chart 5-3-1 Setting 11 5.3.1 Zone Zone is used for setting up and managing the room where the sample is being taken. The information can be added, amended or removed in this menu. The sampling scheme can be associated with the room here. Touch Zoneicon of the left menu in the setting interface to set up the room information. See chart 5-3-2. Chart 5-3-2 Zone Description Title Name The name of the room where the sample is being taken. Touch the input area to enter a new room and add room information, touch icon to save the settings. Touch icon to select an existing room from the pull-down menu. Touch icon to find a room, and touch OKicon to confirm. The room default is a system default room. It can be modified, but it cannot be deleted. See chart 5-3-3. Area The area of the sampling room. Select the standard from the pull-down menu. The standards include ISO 14644-1: 1999, ISO Standards 14644-1: 2015, EUGMP-ISO: 1999, EUGMP-ISO: 2015, Chinese GMP 2010-ISO: 1999, Chinese GMP 2010-ISO: 2015, Fed Std 209E F, Fed Std 209E M. The number of locations in the sampling room. If the area is entered, locations will be Locations calculated automatically depending on the selected standard. The number can be modified. The minimum value is 1. Class Air Flow accordingly. Unidirectional. Select the class from the pull-down menu. If the standard is changed, the class will change, The direction of the air flow in the sampling room. The options are Non-unidirectional and Status The status of the sampling room. The options are Operational, At-Rest and As-Built. Largest selected The size channel, according to the standard, is used to calculate the minimum sampling size volume. Definition See chart 5-3-4. Channels Turn on/off the display and alert of the size channel and set the threshold of the alert value. Sampling SCM Select an existing sampling scheme from the pull-down menu, or touch icon to add a new 12 scheme. One room can be associated with several schemes. See chart 5-3-5. Export zone information and sampling scheme as db files to USB flash drive, or import it from the USB flash drive to the device. When importing the exported db files to the device, the contents of zone information and sampling scheme in the file will overwrite the original Note: When the software version of the device changes, such as the Settings of the zone information and sampling scheme, it may cause import and export failures, or cause device content in the device. crashes. Save new or modified rooms. Delete current room. Empty the current content. Chart 5-3-3 Zone name Chart 5-3-4 Channels Definition Chart 5-3-5 Sampling SCM When modify a room settings, touch icon to select the save method. Select Cover the original zone to save the changes in the original room. And select Save as a new zone to create a new room. See chart 5-3-6 13 Chart 5-3-6 Save options Sampling SCM is used for setting up the scheme for sampling. The scheme consists of volume, sample time, delay, etc. It can be added, amended or removed in this menu. The sampling SCM can be associated with zoom here. TouchSamplingicon of the left menu in the setting interface to set the scheme. See chart 5-3-7. 5.3.2 Sampling SCM Title Name Chart 5-3-7 Sampling SCM Description The name of sampling SCM. Touch the input area to enter a new scheme, touch icon to save the settings. Touch icon to select an existing scheme from the pull-down menu. Touch icon to find a scheme, and touchOKicon to confirm. The scheme named default is a system default sampling scheme. It can be modified, but it cannot be deleted. See chart 5-3-8. Volume The volume of air collected in each sampling. Sample Time The time of each sampling. Delay The time period before the first sampling is being taken. Samples The number of samples on one location. Interval The time period between the samples on one location. Select Auto or Manual from the pull-down menu. Pumping Mode Auto: on one location, the sampling will stop after all the samples are finished. Manual: on one location, the sampling will continue after pressing the start icon, when one 14 sample is completed. Zone Info several rooms. Select an existing room from the pull-down menu. One sampling scheme can be associated with Chart 5-3-8 Sampling SCM name 5.3.3 Data SCM Data SCM is used for configurating the data for reviewing, printing, exporting, print language and storing. Chart 5-3-9 Data SCM Title Description REC rate: the recording rate of real-time data. The minimum is 00:00:05. Real-time data is recorded every 5 seconds. Touch the time area to activate the time keyboard and input the time. Counting Mode Setting the differential/cumulative count mode, particle unit and size channel for the data displaying during the sampling. See chart 5-3-10. Cumulative count: the number of particles in and above the selected channel. Differential count:

the number of particles between the selected channel and adjacent channel. Particle unit: #,

#/ft3, #/m3. Size channel: 0.5/1.0/2.0/3.0/5.0/10.0m. All of the particle size channel or part of the particle size channel can be selected to display. Data Review Auto Print Data Review is used for setting review mode in the data interface. The function and interface of the data review are similar to the counting mode. The data will be printed automatically after each sampling is completed. If NORM mode is selected, data of one location will be printed when sampling(s) of this location are all completed. 15 If the Custom mode is selected, data of each sample will be printed when this sample is completed. ONindicates the auto-print is turned on.OFFindicates the auto-print is turned off. The print information such as Device Model, Calibration Date, Serial NO and statistics

(Average, 95%UCL) can be set. The settings of differential/cumulative count mode, particle unit and size channel are the same as Counting Mode. OffLine Print The function and interface of the OffLine Print are similar to the Auto Print. Export Data The function and interface of the Export Data are similar to the Auto Print. Print Language Chinese and English are supported. Chart 5-3-10 Counting Mode 5.3.4 Display Chart 5-3-11 Display Description Title Sampling Standby If there is no operation within the set time, the device will be in standby during the sampling. If a password is selected, username and password should be entered to wake up the device. Leisure If there is no operation within the set time, the device will be in standby. If a password is selected, 16 username and password should be entered to wake up the device. In standby mode, if no operation is performed on the device within the set time, the device will be Shutdown shut down automatically. Brightness Move the progress bar to adjust the brightness of the screen. Language Chinese and English are supported. Standby Auto 5.3.5 Time Time is used for setting up the system time on the device. Touch the input box on the right of the date and enter the current date. Touch the pull-down menu and select the date format of YY-MM-DD, DD-MM-YY, MM-DD-YY. Touch icon to save the settings. The setting of the time is the same as the date. See chart 5-3-12. Chart 5-3-12 Time 5.3.6 Info Alert Title Chart 5-3-13 Info Alert Description The reminder starts reminding when the next calibration date is a certain number of days CAL. Remind away. If it is less than the set days, " ** days since the last calibration" will display upon startup.ONindicates reminder is turned on.OFFindicates reminder is turned off. Error Alarm

: Audible alarm is turned on.

: Audible alarm is turned off. If laser or flow error occurs during sampling, the alarm will buzz when the audible alarm is turned on. Counting Alarm

: Audible alarm is turned on.

: Audible alarm is turned off. If the number of particles is over the threshold during the sampling, the alarm will buzz when audible alarm is turned on. 5.3.7 Audit Trail An audit trail is a security-relevant chronological record, set of records that provide documentary evidence of the sequence of activities that have affected at any time a specific operation, procedure, or event. All the operations from login to logout can be recorded. It consists of setting, sampling, export data, etc. Each line of 17 the record shows the operators ID and the login time. The records are listed in chronological order. The first line is the latest one. Touch the icon to review the details. See chart 5-3-14, 5-3-15. Chart 5-3-14 Audit Trail 5.3.8 Device Chart 5-3-15 Detailed Audit Trail Device is used for displaying the information of the software and firmware. It includes device name, model, serial number, firmware version, software version, etc. The software can be upgraded on this interface. See chart 5-3-16. Update is used for upgrading the software version. BAMS supports continuous version upgrades and cross version upgrades. Insert the MicronView USB into the USB A port on the back of the device. Touch the Updateicon, search and select the upgrade file, touchicon to confirm. See chart 5-3-17. 18 Chart 5-3-16 Device Chart 5-3-17 Upgrade Operator is used to create and modify accounts. Only the ADMIN account has the right to enter this interface for relevant settings. Description The default account is ADMIN, and the password is 0. The password can be changed, but the ADMIN account cannot be deleted. When creating a new account, enter the account name. Group The level of account is classified as admin, supervisor and operator. Enabled ON: indicates the current account is enabled.OFF: indicates the current account is disabled. The operator account can be configured for different access authority. Access authority include zone, sampling SCM, data SCM, display, time, info alert, device, WIFI,MV connect, audit trail, offline print, export data and clear samples. 5.3.9 Operator Title Account Access Authority 19 Password/

Re-Confirm Set and confirm the password, the two passwords must be the same. Chart 5-3-18 Operator 5.3.10 WIFI WIFI is used for connecting with the wireless network. TouchScanicon to search the wireless network nearby, select the wireless network need to be connected and enter the password. TouchConnecticon to icon on the top right corner of the screen means the network is connected. connect to the internet. The See chart 5-3-19. Chart 5-3-19 WIFI 20 When connecting to the Data Acquisition system of MicronView, enter the IP address of the device. Touch Connecticon to connect to the device. See chart 5-3-20. Chart 5-3-20 Connect MicronView Data Acquisition system Connect to an external device is used for setting IP address of an external device which is ready for receiving the data from the device in the same LAN. The data can be transferred when the IP is set and tested. See chart 5-3-21. Chart 5-3-21 Connect to an external device Description Title IP Shared folder Input the IP address. IP indicates the IP address of the external device (Linux systems) which is ready for receiving the data from the BAMS in the same LAN. Input the NFS (Network File System) shared directory of the external device (Linux systems).

(Note: The share function of the associated device should be turned on.) Touch this icon to open or close the file transfer function. If on is selected, it is divided into two Transfer file cases. (a) With external device is connected, the sample data will be transferred to shared directory during sampling. (b) With no external device is connected, the sample data will be transferred to temporary directory of BAMS during sampling. Touch this icon to detect if the BAMS can connect with the external device in this LAN. If touched, the message Detecting appears. If the connection is correct, the message Click to detect Communication successful. Please save the setting. is displayed. Otherwise, the message Link failed is displayed. When connection failed and Transfer File icon is on, the files can also be saved, but the files cannot be transferred. Re-enter Touch this icon to clear the current content. Touch this icon to clear all the junk files locally cached in the BAMS. (Note: sample data will not Clear File be affected. 5.3.11 MV Connect 21 MV connect is used for the collaborative work of BAMS and BAS by network interconnection. Need to connect the BAMS and BAS in the same wireless network. Enter the IP address of BAS that need to be connected. Set the threshold of the particle/BIO, the threshold can be concentration limit and particle in unit time, set the time unit and sampling volume. See chart 5-3-21. TouchConnecticon to connect the BAMS and BAS, the start sampling, the BAS will start sampling automatically when the particles exceed the threshold. icon will display on the upper-right of the screen after successfully connecting. When BAMS Chart 5-3-21 MV Connect 5.4 Sampling Chart 5-4-1 Sampling 22 Description Title Zone Status TouchZoneicon to open the room list, and select the sampling room. TouchStatusicon to select the status of the sampling room. The options are Operational, At-Rest and As-Built. Sampling SCM TouchSampling SCMicon to open the sampling scheme list, and select the sampling scheme. Sampling rule consists of NORM mode and Custom mode. The NORM mode is used for the samplings per ISO/EUGMP/CHINESEGMP/Fed Std. Under this mode, parameters cannot be modified after the room and sampling scheme are selected (the background of sampling Sampling Rule conditions turn to grey.) If the sampling process is stopped, the result of the standard report is invalid. The Custom mode is used for sampling for other purposes. Under this mode, sampling parameters such as location, volume, sample time can be modified and a sampling can be stopped at any moment. Locations the Custom mode. The location cannot be changed under the NORM mode. It can be a selection list option under In auto mode, the first sample of each location complies with the delay. The following samples Delay/

Interval comply with the interval. In the case of manual mode, all samples comply with the delay. The sampling can be stopped during delay and interval. Press the start icon again to continue the sampling. In the case of custom mode, delay and interval can be changed at any moment. The countdown mode is used for delay and interval. Volume Sample Time Samples This shows the current sampled volume (above the line) and total volume of the sample (below the line). In NORM mode, the volume cannot be changed. This shows the current sampled time (above the line) and total time of the sample (below the line). In NORM mode, the sample time cannot be changed. This shows the number of samples which are being taken in the current location (left of the split) and the total number of the samples (right of the split). Operator The operators account. Beep BEEP Mode: a beep will emit when sampling value of preset particle size range reaches the threshold. TouchBeepicon to select the beep mode, and the parameter menu will display. See chart 5-4-2. Set the particle type, particle range and threshold. Auto Sample If checked, the sampling will stop after all the samples on one location are finished. Auto Print If checked, the data will be printed automatically after each sampling is complete. If NORM mode is selected, data of one location will be printed when sampling(s) of this location are all completed. If manual mode is selected, data of each sample will be printed when this sample is completed. Graph channel in real time. The curves show the instantaneous data of the 0.5m particle, 5.0m particle and bioparticle Location display It shows the number of locations in the sampling room. Flashing green light indicates the sampling is underway in this location. Green light indicates the location which the sampling has completed. Flashing red light indicates alarm appears during the sampling, and this location should appear in red. In NORM mode, the location will appear in red light if sampling is artificially terminated. See chart 5-4-3. Set the counting mode, counting unit and size channel for the data displaying during the sampling. Counting mode consists of cumulative count and differential count. Cumulative count: the 23 number of particles in and above the selected channel. Differential count: the number of particles between the selected channel and adjacent channel. Counting unite: #, #/ft3, #/m3. Size channel: 0.5/1.0/2.0/3.0/5.0/10.0m. All of the particle size channel or part of the particle size channel can be selected to display Print the sample data. Chart 5-4-2 Beep mode Chart 5-4-3 Location display When all the sampling conditions are set, touch icon to start sampling. Touch icon to stop sampling. If over-limit alarm occurs during the sampling process, the background of over-limit value will turn to red. If the audible alarm is turned on, the buzzing alarm will be continuous. Touch red area to turn it off. 5.5 Data Data is used for reviewing, exporting and printing the sampling records and alarm records. See chart 5-5-1. 24 Chart 5-5-1 Data Title Description TouchMore functionicon to open the extended menu bar, touch again to close it. The extended function includes Error RECs, Print Data, Export Data, Delete Data and Graphs. Touch the corresponding function icon to open the function interface. See chart 5-5-2. To review the list of error records. The errors consist of flow errors and laser errors. Touch any record to view all the content for that record. When there are more records than shown on the screen, touch the up arrow or down arrow to move up and down the screen. Print the data, touchOKicon to print out. Export PDF file is used for exporting the period records to a USB flash drive as PDF files. One or multiple period records can be exported. multiple period records can be exported. Export Excel file is used for exporting the period records to a USB flash drive as Excel files. One or Export data file is used for exporting the data source (db file) of period records to a USB flash drive. Deleteicon, touch it and the prompt According to data management, all sample data of this device will be deleted will pop up, touchOKicon to delete. Graphicon, touch it to gathering the real time data in graphical form. See chart 5-5-3. 25 Returnicon ,return to the previous menu. Searchicon, find the required records via search criteria such as start/end date, operator and zone. Clearicon, clear the current content. Set the counting mode, counting unit and size channel for the data displaying during the sampling. To generate the standard report compliance with ISO, EUGMP, CHINESEGMP and Fed Std. The data will be analyzed statistically to determine if the samples meet the requirements according to the selected standard. The result shows Pass when the requirements are met, otherwise the result shows Fails. If the sampling conditions do not meet the minimum requirements, the result shows Invalid. Chart 5-5-2 More function Touch any data to open the detailed data table. See chart 5-5-4. Touchicon to review the real time data. See chart 5-5-5. Chart 5-5-3 Graph 26 Chart 5-5-4 Detailed data Chart 5-5-5 Real time data 5.6 Shutdown Press the power button, and the shutdown prompt appear. 27 Chart 5-6-1 Shutdown Title Description Shutdown Shut down the device. Standby The screen dims and goes into standby mode. Touch the screen to light up again. Lock If the screen is locked, no operation can be performed. Touch the screen to login again, and unlock it. Operator Login screen pop up to change the users account. 28 Chapter 6 Printer 6.1 External Dimensions Part Name 1. Paper Cover 3. USB Port 5. Battery Indicator 7. Error Indicator 9. Power Port 6.2 Operating Procedure 6.3 Install paper roll 6.4 Specifications Printing method Printing width Resolution Printing speed Paper requirements 29 Dimensions (lengthwidthheight) 120mm 97mm 49mm 2. Paper Exit 4. Power Button 6. Mode Indicator 8. Feed Button 10. RS232 Port 1) Press the POWER button to turn on the printer. 2) TouchWIFIicon in the settings interface of BAMS, then touchScanicon, select the WIFI named RG-MDP58B, touchConnecticon (no password needed). After the connection is successful, the WIFI logo will appear in the upper right corner of the screen. 3) Make sure the paper has been installed. Print the data via BAMSs print function. 4) Press the POWER button to power off after printing is completed. To install the paper roll into the printer, pinch each end of the paper cover to open it, and insert the paper roll

(the glossy side of the paper face down). Pull out a small amount of paper, then close the cover. In the power-on state, press the Feed button to feed the paper and release it to stop. Lattice stylus printing 48mm 127 dpi (5 dot/mm), 240 dot/line 6.6 mm/sec Width: 58mm, thickness: 60-85m Connection Supply mode WIFI DC 12V 2A or 2000mAh, 7.4V rechargeable lithium battery. Operating temperature/humidity Storage temperature/humidity 0C~50C/10~80% RH 20C~70C/10~95% RH Approx. 250g ((without paper roll and battery) Weight 30 Chapter 7 Troubleshooting and Maintenance 7.1 Troubleshooting Hardware and software No. Common Problem Possible Cause Corrective Action Communication fault, please see Section '6.1 Troubleshooting' of the BAMS users manual is displayed. The loading bar is no response when export too much data. Battery information error;

The remaining charge

(available) time is in error;

Battery abnormal. Please shut down to check. is displayed. Severe electromagnetic interference or system malfunction. Internal parts are damaged. Confirm to shut down the device and restart. If the problem persists after restart, return to MicronView or the local distributor for service. AC adapter is not plugged or the battery is dead Check the AC adapter and re-plug it,. Then re-start the device. Too much data is selected to export. The USB flash drive is damaged. The USB port is damaged. Too much data may cause long delays. If there is no response, touch the return button to export again. Contact MicronView or the local distributor. Return to MicronView or the local distributor for service. System malfunction. Shut down and restart the device. The battery is in poor contact. Internal parts are damaged. Standby is not turned on. Shut down the device. Reinstall the battery and restart. Return to MicronView or the local distributor for service. Turn on the standby in the setting interface. Internal parts are damaged. Return to MicronView or the local distributor for service. System malfunction. Shut down and restart the device. 4 Unable to standby. System malfunction. Shut down and restart the device. 5 Device does not turn on. Internal parts are damaged. Device does not shut down. System malfunction. Internal parts are damaged. Wired or wireless network error Network configuration settings are not in accordance with the user manual. Return to MicronView or the local distributor for service. Touch the shutdown icon repeatedly. If the problem persists, long press the power icon for 10 seconds to force a shutdown and restart. Return to MicronView or the local distributor for service. Set the network configuration in accordance with the user manual. 1 2 3 6 7 31 8 9 11 12 13 14 Network cable is in poor contact. Severe environment interference. Internal parts are damaged. Reconnect the network cable or replace with another one. Move the device away from the metal shield of the environment. Return to MicronView or the local distributor for service. System malfunction. Shut down and restart the device. Return to MicronView or the local distributor for service. Turn on the audible alarm in the setting interface. Audible alarm is not turned on. System malfunction. Shut down and restart the device. Internal parts are damaged. Return to MicronView or the local distributor for service. Blower does not work when sampling. Internal parts are damaged. Error alarm or counting alarm is without voice prompt. Hardware Internal short circuit. 10 Device does not turn on. The AC adapter does not work. Internal parts failure. Power button failure. Battery failure. Battery aging. AC adapter failure. Battery cannot be charged when AC adapter is working properly. Battery cannot be fully charged when AC adapter supply. Device suddenly power off when AC adapter is connected. Device suddenly powers off when battery is connected. Low battery Battery failure. 15 Flow error Inlet is blocked. Internal gas path failure. Battery is in poor contact. Check and plug in the battery again. Internal parts failure. Return to MicronView for service. Operating environment does not meet requirements. Operate the device in the required environment. Observe the indicator light when supply with AC adapter. If the light is off, return to MicronView for service. If the light is on, an internal short circuit is not the issue. If the problem persists after plugging in the AC adapter again, replace the AC adapter. Return to MicronView for service. Return to MicronView for service. Contact the factory to replace the battery Contact the factory to replace the battery If the problem persists after replacing another AC adapter, return to MicronView for service. Plug in the AC adapter and restart the device. Contact the factory to replace the battery Check if there is any blockage inside the inlet. If not, Return to MicronView or the local distributor for service. Return to MicronView or the local distributor for service. 32 Sensor failure. Device has been in use for a long time. Internal parts are damaged. Return to MicronView or the local distributor for service. This is a normal phenomenon. Operate the device in the specified environment in accordance with the user manual. Shut down the device and do not operate for a period of time (can vary). If the problem persists after restart, return to MicronView for service. 16 Enclosure of the device is overheating 17 Touch screen failure or insensitive touch Touch screen needs adjusting. Adjust the touch screen. Touch screen is damaged Return to MicronView for service. Temperature or relative humidity does not meet the requirements. Operate the device in the required environment. 18 Counts are too low. Internal parts are damaged caused by high concentration sample or sample condensation. Return to MicronView for service. 19 Fail to zero count when HEPA filter is connecting. Laser is damaged. Return to MicronView for service. Device needs calibration. Return to MicronView for service. Flow error. HEPA filter is not installed properly. Return to MicronView for service. Check the connection of HEPA filter and the position of black O-ring seal. HEPA filter exceeds service time. Replace the HEPA filter. Optical part is polluted. Return to MicronView for service. Internal parts are damaged caused by collisions, or excessive vibration. Return to MicronView for service. Internal gas path leak. Return to MicronView for service. 20 Display screen is blurred. System malfunction. Touch screen is in poor contact or it is damaged. If the problem persists after shutdown and restart, return to MicronView for service. Return to MicronView for service. 7.2 Maintenance Item Frequency Operation Zero count After each use or as needed. Connect the HEPA filter to the inlet using short tubing. Start sampling for 5 minutes. If the result <1count, the zero count is completed. Clean the surface According to operating conditions or as needed Clean the device surface with a clean wipe wet with 70-80%

ethyl alcohol or isopropyl alcohol. Battery charging Recommend once 3-5 month Plug in the AC adapter for charging. If the battery is not in use for a long time, the battery will start self-protection. Connect the AC adapter to activate the battery. 33 Calibration Once a year Return the instrument to the factory or a qualified company. 7.3 Return for Service If the instrument failure cannot be solved and needs to be returned to us, please contact. Contact information: service@micronview.com. 34 Chapter 8 Warranty We offer a one-year warranty for the BAMS including hardware and software from the date of activation. It is considered activation when cumulative sampling for 30 minutes. The repair service and parts replacement are warranted for 6 months from the date of the shipment. In these cases, the warranty is void. a. The warranty is void if the BAMS is repaired and disassembled by the company or person without authorization. b. Damage is due to mishandling or operator misuse. We offer the free remote upgrade service for life when the users require during use. The BAMS is a precision instrument. It must be operated by trained laboratory personnel only. 35

MICRONVIEW BioAerosol Monitoring System |BAMS Model M110 CHANNELS 0.5/1.0/2.0/ AC Adapter 3.0/5.0/10.0um, SLPM INPUT 100-240VAC S0/60Hz INPUT DC 24V 375A 1.30.68 BATTERY 11.1V 7.8Ah OUTPUT 24V3.75A 90W MAX Manufactured:February 2019 CMIIT ID. 110 ll AUN ==>" == ID2AHRO-EPNSS0ECS mm PE CE Micron View Ltd /)

Micron View limited Agent Authorization Company: Micron View Limited Address: Suite 1, 3rd Floor,11-12 5 t. James's Square, London, SW1Y 4LB, United Kingdom Product Name: BioAerosol Monitoring System Model Nurnber(s):M110 Product Description The BioAer~l Monitoring System (BAM'S) is used to detect both inert and microbial particles in real-time, primarily in clean rQom environments. It is appropriate for use across many industries, such as aerospace, biopharmaceutical, medicine & health, electronics d and optics. Its maio applications are clean class cl sification clean room validation, contaminant source trackir ind air quality monitoring, contaminant trend analysis C. The instrument providesthe al-time feedback ofair quality in clean rooms by monitoring both inert and microbial particles and can run 24x7 Contaminants can therefore be found early because ofthe contnuous andreal-tme monitoring BAM'!>S saves users time and enables more immediateactionand resolution. Withouttraditional culturingmethodology andconsumable BAMo!I$ helps reduce both costs and reaction times We aulhorize MiCOM labs Inc., 575 Boulder Court, Pleasanlon , California 94566 , USA, 10 acl on ur behalf on all malters concerning the ceficalion of above named equipment We declare thal MiCOM labs Inc. is allowed 10 forward all information reJaled 10 Ihe approval and certification of equipmenl 10 the regulatory agencies as required and 10 discuss any issues concerning the approval appficalion. Any and all acls carried out by MiOM labs on our behalf shall have the same effect as acts of our own Slgnature Name

Company: M rn I, ",) Da A4

Micron View Limited Office of Engineering Technology Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 USA Date: 2020.04.21 Subject; Request for Confidentiality FCC ID: 2AV6V-M110 To Whom It May Concern, Pursuant to the provisions of the Commissions rules Title 47 Sections 0.457 and 0.459, we are requesting the Commission to withhold the following attachment(s) as confidential documents from public disclosure indefinitely. These documents contain detailed system and equipment descriptions and are considered as proprietary information in operation of the equipment. The public disclosure of these documents might be harmful to our company and would give competitors an unfair advantage in the market.

[XX] Schematic Diagram

[X] Block Diagram

[_] Parts List Operational Description _] Tune-up Procedure In additional to above mentioned documents, in order to comply with the marketing regulations in Title 47 CFR 2.803 and the importation rules in Title 47 CFR 2.1204, while ensuring that business sensitive information remains confidential until the actual marketing of newly authorized devices, we request Short Term Confidentiality of the following attachment(s):

XX] External Photos XX] Test Setup Photos XX] Internal Photos X] User Manual _] For 45 days, pursuant to Public Notice DA 04-1705. OR

(X] For 180 days pursuant to KDB 726920 DO1. It is our understanding that all measurement test reports, FCC ID label format and correspondence during the certification review process cannot be granted as confidential documents and this information will be available for public review once the grant of equipment authorization is issued. Sincerely, Signature: 3 shot chen Name: Dong STM chen Title: production mandhor