AccuFIT 9000 Operation Manual Rev 13

Component List ■ Standard ITEM Main Unit AC Adapter（100-240V、12V 2A） Power Cord Zero Filter Alcohol Storage Container Storage Cap Alcohol Cartridge Spare Felt/Wire Mesh Software CD Twin Tube (1m) Carrying Case

MODEL AF90-ADP AF90-AFC AF90-CAP AF90-ACR AF90-AWK

QTY 1 1 1 2 1 1 1 2 1 １ １

■ Consumables ITEM Zero Filter Alcohol Cartridge Spare Felt / Wire Mesh

MODEL

QTY 2 1 2

For more details about the consumables, please contact your distributor.

i

Laser Classification

Laser Classification This device is classified as a Class 1 Laser Product in accordance with the following standards: ● EN60825-1: 2007 ● I EC60825-1: 2007 CLASS 1 LASER PRODUCT EN60825-1 : 2007

*Class 1 Laser: Lasers that are considered to be safe under reasonably foreseeable conditions of operation, including the use of optical device for intrabeam viewing.

Laser Safety Information Warning － This device employs a laser inside the unit as the light source of the sensor. Do not open/close the case of unit or disassemble the optical sensor inside the unit.

Wave length

650nm

Maximum output

20mW

Caution － Any attempt by user to control, adjust, or perform maintenance procedures other than those specified in this manual may result in hazardous exposure to laser radiation.

ii

Important Safety Information

Important Safety Information The symbols for the warnings used in this manual are defined below:

Classifications Warning: Warnings in this classification indicate risks that may result in serious injury or death if not observed.

Caution: Warnings in this classification indicate risks that may result in damage to the product and which may void the product warranty if not observed.

Description of Symbols △ symbol indicates a condition that requires caution (including warning). The subject of each caution is illustrated inside the triangle. (e.g. the high temperature caution symbol is shown on the left.)

symbol indicates a prohibition. this symbol.

Do not take the prohibited action shown inside or near

(e.g. the disassembly prohibition symbol is shown on the left.)

● symbol indicates a mandatory action. A specific action is given near the symbol.

Warning ○ Do not disassemble, modify, or attempt to repair the device.

Do not modify or disassemble

…… A 3B laser diode is used as the optical source inside the device. Never attempt to disassemble the device as it is potentially extremely dangerous. Also, disassembling the unit may result in a malfunction. ○ Use the device properly by carefully following this operation manual.

Handle properly

…… As with any electric device misuse may result in electric shock, fire, damage to the instrument, etc.

iii

Important Safety Information

○ If any abnormal noises, unusual odor or smoke is observed, or any liquid is permitted to enter into the instrument, turn the power off immediately, remove the battery or disconnect the power cable if connected. …… These conditions may result in electric shock, fire, or damage to the instrument. Contact your distributor.

Do not use this instrument in ambient temperature of 37℃ (99℉) or greater. Prohibited installation

…… The performance may deteriorate significantly and component damage may result. ○ When the instrument is not in use, unplug the power cord. …… Failure to observe the above may result in electric shock, fire or damage to the internal circuit. ○ Install the instrument in a location where the power cord is accessible such that you can disconnect the power cord easily. ○ When using the power cord, make sure that the plug is clean and dry. ○ The AC outlet must be within the specified power requirement. …… Failure to observe the above may result in fire. ○ Use only the power cord and/or the AC adapter provided with this instrument. …… Other commercially available cords may have different voltage specifications and polarity, which may result in short circuit, fire or damage to the instrument.

Caution

Prohibition

Prohibition

○ Do not use or leave this instrument in an environment exceeding or falling below the specified temperature/RH levels for the instrument. The instrument should not be exposed to direct sunlight for a prolonged period of time. …… This instrument may not function properly beyond the specified operable environment. (5 to 35℃, 20 to 85％RH, with no condensation) ○ Do not use volatile solvents to clean the instrument. …… The case of the main unit may be damaged by organic solvents. Use a soft dry cloth to remove any dirt. If this is not effective, the user may soak the cloth in neutral detergent or water and wipe the instrument with the cloth. Never use volatile solvents such as thinner or benzene.

Important Safety Information

Prohibition

iv

○ Do not subject the instrument to strong shocks. Do not place heavy objects on the instrument. …… Failure to observe the above may cause malfunction or damage to the instrument.

○ If the instrument has been stored in a cold environment, allow the instrument to come to temperature equilibrium with the environment in which it will be operated before turning it on. Prohibition

……Even when the instrument is used in the specified operating temperature and humidity, a sudden temperature change may cause condensation. Condensation on the sensor may cause inaccurate measurements or in extreme situations, could damage the internal components. ○ Do not allow static electrical discharge to the instrument. …… Failure to observe the above may affect the measurement value and cause damage to the instrument circuitry. ○ Do not let the instrument draw in highly concentrated particles that exceed the specification level. (i.e., >100,000 particles/cc)

Handle properly

○ Do not dispose of the instrument as Non-electronic waste.

Prohibition

…… Please note that any disposal of the instrument should be in line with your local or national regulation. For details, please contact your local distributor.

Table of Contents 1. Part Names and Functions ... 1 1.1 Main Unit ... 1 1.2 Software Screen ... 2

2. Principle of Measurement ... 4 2.1 Principle ... 4

3. Getting Started ... 5 3.１Recharging the Alcohol Cartridge ... 5 3.1.1 Preparation ... 5 3.1.2 Recharging the Alcohol Cartridge ... 6 3.1.3 Installing the Alcohol Cartridge ... 7

3.2 Getting Started (Main Unit) ... 8 3.2.1 Confirming the External Memory ... 8 3.2.2 Database Selection ... 9 3.2.3 Particle Check ... 9 3.2.4 Zero Check ... 9 3.2.5 Fit Factor ... 10 3.2.6 Validation Check Settings ... 10

3.3 Get the Person being Tested Ready ... 10

4. Measurement ... 12 4.1 Step 1 ... 12 4.2 Step 2 ... 12 4.3 Step 3 ... 13 4.4 Step ４ ... 14 4.5 Record ... 14 4.6 Print... 15 4.7 Real-time Measurement ... 15 4.8 Toolbox (Advanced Modes) ... 16 4.9 Remote Control Mode ... 16

5. Administration and Setup ... 17 5.1 Administration ... 17

5.1.1 People ... 17 5.1.2 Respirators ... 17 5.1.3 Protocols ... 18 5.1.4 Fit Test Reports ... 19 5.1.5 Select Database ... 19 5.1.6 Toolbox ... 20

5.2 Setup ... 20 5.2.1 Printer Setup ... 20 5.2.2 Communication ... 20 5.2.3 Settings ... 23 5.2.4 Date and Time ... 23 5.2.5 Touch Screen Calibration ... 24 5.2.6 Device Info ... 24

6．Maintenance ... 25 6.1 Calibration ... 25 6.2 Alcohol Cartridge ... 25 6.3 Mesh (Inlet) ... 27

7. Specifications ... 28 8. Troubleshooting ... 29 9. Contact Information ... 31

1

1. Part Names and Functions

1. Part Names and Functions 1.1 Main Unit A ・Front B

C

D E

F

G

H

I

J

・Back

K

(A)

Power button

On/Off switch

(B)

Touch panel

Use this screen to operate the system.

(C)

Inlet nozzle (ambient)

Instrument

uses

this

inlet

to

sample

the

particle

sample

the

particle

concentration in the ambient air. (D)

Inlet nozzle (sample)

Instrument

uses

this

inlet

to

concentration inside of the mask. (E)

Stylus

Use this pen to operate the touch panel (B).

(F)

Alcohol cartridge

Contains alcohol that is necessary for measurement

(G)

USB port (Type B)

Connects to the PC

(H)

USB port (Type A)

Connects to the USB flash drive or the printer

(I)

LAN port

Connects to the LAN cable

(J)

AC jack

Supplies power from the provided AC adapter

(K)

Cooling fan

Maintains correct operating temperature (This cooling fan is to maintain appropriate processing temperatures.)

2

1. Part Names and Functions

1.2 Software Screen ①Activities （1）

（4）

（2）

（3）

（5）

(1)

Fit Test

Allows the user to perform respirator fit test

(2)

Validation Check

Allows user to conduct a system check prior to performing series of measurements

(3)

Realtime

Displays the fit factor graph or particlulate concentration of the ambient air on a real time basis

(4)

Administration

Proceeds to the screen ② (Refer to 5. Administration and Setup for details.)

(5)

Proceeds to the screen ③

Setup

(Refer to 5. Administration and Setup for details.) ② Administration

(6)

People

（6）

（7）

（8）

（9）

（10）

（11）

Confirm and selects the list of people being tested. Portal to enter a new person to database

(7)

Respirators

Confirm and selects the list of respirators Portal to enter a new respirator to database

3

1. Part Names and Functions (8)

Protocols

Confirm, edit, and select the test protocol Portal to enter a new test protocol to database

(9)

Fit Test Reports

Display and print the reports of conducted fit tests

(10)

Select Database

Select database to load as active; create new database

(11)

Toolbox

Proceed to the advanced mode

③ Setup

（12）

（13）

（14）

（15）

（16）

（17）

(12)

Printer Setup

Configure the printer setting

(13)

Communication

Configure and set the PC communication environment

(14)

Settings

Configure the settings for the device

(15)

Date and Time

Edit the date and time setting

(16)

Touch Screen Calibration

Calibrate the touch screen

(17)

Device Info

Check the device information

4 2. Principle of Measurement

2. Principle of Measurement 2.1 Principle This device measures particle concentration in the ambient air and inside of the mask, and determines how well a mask fits by comparing the ratio of these particle concentrations. ratio of the above concentrations is called "fit factor".

The

If the fit factor is 100, it essentially means

that the inside of the mask is 100 times as clean as the ambient air.

Fit factor＝

𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃 𝑃𝑃𝑐𝑐𝑐𝑐𝑃𝑃𝑃𝑃𝑐𝑐𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑐𝑐𝑐𝑐 𝑃𝑃𝑐𝑐 𝑃𝑃ℎ𝑃𝑃 𝑃𝑃𝑎𝑎𝑎𝑎𝑃𝑃𝑃𝑃𝑐𝑐𝑃𝑃 𝑃𝑃𝑃𝑃𝑃𝑃 𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃 𝑃𝑃𝑐𝑐𝑐𝑐𝑃𝑃𝑃𝑃𝑐𝑐𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑐𝑐𝑐𝑐 𝑃𝑃𝑐𝑐𝑖𝑖𝑃𝑃𝑖𝑖𝑃𝑃 𝑐𝑐𝑜𝑜 𝑃𝑃ℎ𝑃𝑃 𝑎𝑎𝑃𝑃𝑖𝑖𝑚𝑚

In the older protocols, the device measures particle concentration in the ambient air twice in total, before and after each mask fit test exercise.

Particle concentration in the ambient air can be

variable over time; therefore this device measures the particle concentration in the ambient air before and after each measurement, and uses the average value.

The particle concentration in

the ambient air must be measured for the first measurement. For the second measurement and subsequent measurements, the concentration after the previous measurement will be used and there is no need for a redundant second measurement of the ambient air.

The sequence would thus be as follows: Cambient // Cmask // Cambient // Cmask // Cambient …etc. F: Fit factor C b e f o r e ：Particle concentration in the ambient air before measurement C a f t e r：Particle concentration in the ambient air after measurement C m a s k：Particle concentration inside of the mask Note: Newer OSHA protocols approved in 2019 consist of 4 30-second exercises with the ambient measurements taken before and after the complete suite of exercises. Empirical data show that the ambient particulate concentration varies very little over two minutes, which is the time required to perform the exercises. Careful observation shows that the preliminary value of the fit factor for each exercise will change slightly as the test finishes when the two ambient values are averaged.

3. Getting Started 5

3. Getting Started 3.１Recharging the Alcohol Cartridge Isopropyl alcohol used for this device is a hazardous material. Do not allow the alcohol to contact your eyes and skin. Warning

Refer to the Safety Data Sheet (SDS) for chemical material when storing alcohol in a special container and when using it. Recap the alcohol container immediately after use to prevent the alcohol from absorbing moisture and from evaporating.

Caution

The AccuFIT 9000 must be operated on a level surface, since tipping the unit may allow alcohol to enter the optic bench.

The CPC (Condensation Particle Counter) in this device detects particles using isopropyl alcohol vapor. Installing the alcohol cartridge soaked in the alcohol solution to this device will provide the alcohol vapor in the CPC. When the alcohol vapor and an airborne particle come in contact, a cloud which has the particle at its center will be formed. As this cloud passes into the condenser the alcohol becomes tightly bound to the particle, thus increasing its diameter several orders of magnitude. If the alcohol solution in the alcohol cartridge becomes depleted, the device cannot measure particles correctly. To avoid this, please recharge the alcohol cartridge before using the device. 3.1.1 Preparation Isopropyl alcohol and the following components are required. ・Alcohol storage container ・Storage cap ・Alcohol cartridge The isopropyl alcohol used for this device must be a high-purity guaranteed reagent alcohol. Please do not use isopropyl alcohol that is available from pharmacies or supermarkets.

The

purity of this alcohol is low (about 70%), and may cause damage to the CPC. Any problems caused by a use of alcohol other than specified below is not covered by the warranty. Please be sure to use the appropriate alcohol with strict adherence to the handling directions. The alcohol used for this device must be a guaranteed reagent satisfying at least the following requirements: Chemical name:

2-Propanol

Synonym:

Isopropyl alcohol

Chemical formula: (CH3)2CHOH Formula weight:

60.10

Assay:

99.5% or better

3. Getting Started 6 When the device is not in use, the alcohol cartridge must be stored in the alcohol storage container and the alcohol cartridge inlet must be sealed with the storage cap to keep dust out. When the device is in use, the storage cap must be used to seal the alcohol storage container. 3.1.2 Recharging the Alcohol Cartridge

Do not leave the alcohol cartridge inlet open. Failure to observe the above may cause contamination of the optical Caution

system or a malfunction.

1. Turn the device off. 2. Open the alcohol storage container by turning the storage cap (or the alcohol cartridge) about 45° counterclockwise.

Stand the storage cap (or the alcohol cartridge) straight up in a clean place.

3. Pour isopropyl alcohol in the alcohol storage container up to the marked level. Be careful not to tip the bottle and spill the alcohol prior to seating the wick or storage cap, Once the wick assembly or storage cap is seated securely in the capsule the alcohol will not leak.

Fill level 4. Insert the alcohol cartridge into the alcohol storage container, and turn it about 45° clockwise until it is firmly locked. Do not use excessive force.

5. After the alcohol cartridge is inserted, the felt in the cartridge will be soaked in alcohol.

You can use the device after a few minutes of

soaking the felt in alcohol.

3. Getting Started 7

3.1.3 Installing the Alcohol Cartridge 1. Remove the alcohol cartridge from the alcohol storage container and gently shake off any excess alcohol solution. Failure to do this may cause the absorbed alcohol to clog the front of the alcohol cartridge.

As a result, the flow of the

incoming airborne particles and alcohol vapor will be disturbed, making it impossible to measure correctly. Please wait until the outer surface of the alcohol cartridge dries or wipe the excess alcohol off with a non-abrasive lint-free wipe. The front of the Alcohol cartridge

2. Insert the alcohol cartridge into the inlet as shown on the right, and turn the alcohol cartridge clockwise about 45°.

To install the alcohol cartridge correctly, be sure to turn it firmly until it stops. (See the picture at right.) 【Caution】 If alcohol accumulates inside the cartridge inlet, wipe the alcohol off with a non-abrasive, lint-free wipe.

3. Getting Started 8 ・ To prevent the alcohol from absorbing moisture and from evaporating, always recap the alcohol storage container with the storage cap. Contaminated alcohol must be disposed of. Caution

・When the device is not in use, the alcohol cartridge must be stored in the alcohol storage container. To keep the inside of the instrument clean, seal the cartridge inlet with the storage cap. ・Do not carry or store the device with the alcohol cartridge installed. Failure to observe the above may allow the alcohol solution to get into the optical system and affect measurements. When carrying or storing the device, seal the alcohol cartridge inlet with the storage cap to keep dust out. ・Always keep the storage cap and alcohol cartridge clean. (Refer to 6. Maintenance.) If dust sticks to the side of the cartridge or inside of the cap, it may get into the device during operation, affecting measurtement. ・After measuring for a long period of time, alcohol may accumulate inside the cartridge inlet. If you notice that the measured value of the ambient particle concentration has shifted dramatically check the cartridge inlet, and wipe the accumulated alcohol off with a non-abrasive, lint-free wipe before restarting the device.

3.2 Getting Started (Main Unit) Turn on the device to display the Activities screen (①).

Prior to performing a series of fit tests,

you should perform Validation Check (2) to confirm that the device is operating correctly and the environment is appropriate for measurements (i.e., that there are sufficient particles present and the instrument can measure them). The Validation Check also tests the MAC valve which cycles between the ambient sample and mask sample. Failure to perform the Validation Test may cause unreliable test results. The results of the Validation Check are saved to the database and can be referred to in future to prove that the instrument was operating properly at the time of the fit test. Always ensure that a Validation Check is performed prior to conducting a mask fit test or a series of fit tests. If the AccuFIT 9000 is connected to and is being controlled by the PC, the results will be saved to the database in use in the PC-based software, but if the instrument is being operated in stand alone mode the user should ensure that a properly configured USB thumb drive has been inserted and that a database has been loaded. 3.2.1 Confirming the External Memory This device does not have a built-in memory to record the measurement results. Before starting a measurement, make sure that a USB flash drive that has been configured with the required information to perform measurement is connected to the device.

3. Getting Started 9 3.2.2 Database Selection

Insert the USB flash drive into a USB port Type A (H) of the device, prior to performing Validation Check (2). Select the desired database and tap [Load] then tap [Fit Test] or [Exit] button. By tapping the [Refresh] button, the databases in the pull-down menu box will be updated to display the databases stored in the USB flash drive.

3.2.3 Particle Check

Remove the HEPA filter or the mask if attached, and tap the [Start] button to check that the particle concentration in the ambient air is sufficiently high enough to calculate the mask fit factor. Depending on the ambient particle concentration (i.e., outside of the mask), the environment may be inappropriate to perform a mask fit test. This process also confirms that the device is operating properly. When this measurement is complete, procede to the Zero Check

3. Getting Started 10 3.2.4 Zero Check If a leak occurs in the sample train of the device, the test result may be affected. The Zero Check determines that there are no internal leaks or loose connections. Install the HEPA filter to the clear sample inlet line (making sure that the arrow on the HEPA cartridge is aligned with the flow), and tap [Next] to begin the Zero Check measurement. When the Zero Check is complete the AccuFit 9000 automatically continues to the next check.

3.2.5 Fit Factor

To confirm whether the device performs correctly, this test confirms the fit factor using the HEPA filter. The instrument measures the particle concentration in the ambient air and calculates the ratio to the particle concentration via the HEPA Filter. By determining this ratio, the device confirms that it is correctly performing this function. If the Validation Check is passed, a message "Test Passed" will appear. If no message appears, perform Validation Check again. *If there is no database, the alarm appears. Execute the Save As command from Toolbox (11) to create a database.

3. Getting Started 11 3.2.6 Validation Check Settings By tapping the [Setting] button on the Validation Check screen, you can change the value(s) for the check as necessary. After changing the value(s), tap the [Save] button to save the change(s). Recommended

values

are

>/=

1000

Minumum particles, </= 20 Zero particles, and >/= 100,000 Max Fit factor

3.3 Get the Person being Tested Ready Prior to a mask fit test, attach the mask to the inlet of the Device using the appropriate adapter, have the person being tested don the mask and check the seal of the mask by himself or herself, and confirm that he or she is wearing the mask properly.

After that, the person being tested

must continue to wear the mask for approximately 5 minutes (29 CFR 1910.134) to clear the respirable particles from inside of the mask, and then proceed to the measurement process. Every person being tested for respirator fit must have been previously trained in the proper procedures for wearing respiratory protective devices. measurements.

Inappropriate use may result in inaccurate

The mask may not be adjusted once a fit test is initiated in order to ensure the

reliability of the fit test results.

12 4. Measurement

4. Measurement 4.1 Step 1

Fit Test Tap Fit Test icon (1) on the Activity screen ① to start a measurement. *If Validation Check (2) has not been completed, the screen for the check will be displayed. Refer to 3.2 Getting Started (Main Unit) to conduct the check prior to a measurement. SELECT PEOPLE If the person to be tested is already in the database, select the name from the pull-down menu. When the person is being tested for the first time, or is not in your database the subject's data must be entered prior to the fit test. Tapping the [New] button allows these data to be entered. Use the provided touch pen (stylus) and display keypad to enter the personal information. When the entry is complete, tap the [Save] button to finish the entry.

4.2 Step 2

Mask size Select the size (Small, Medium, Large, Other, or One Size Fits All) Note: User may enter another size (e.g., “Regular”) which will be saved in the database, but which will not be available in the drop-down menu. SELECT RESPIRATOR Select the mask to use for the test. If the mask is already in the database, you can select it.

If the

mask is not already in the database it must be entered prior to the test.