IQ and OQ Protocol MET ONE 3413 Counters

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Installation Qualification/ Table of Contents

Operation Qualification 1 Preface ............................................................................................................................... 5


1.1 Installation Qualification Purpose ................................................................................ 5
(IQ/OQ) Protocol 1.2 Operation Qualification Purpose.................................................................................. 5
1.3 Disclosures .................................................................................................................. 5
1.4 Revision History .......................................................................................................... 5
MET ONE 3400 Series Airborne 1.5.1 Verifier Responsibilities .......................................................................................... 6
Portable Particle Counters 1.5.2 Customer Responsibilities...................................................................................... 6
1.5.3 Signature Log......................................................................................................... 6
2 Procedure Guidelines ......................................................................................................... 7
2.1 Test Execution............................................................................................................. 7
Note: Use this document for
2.2 Pass/Fail Criteria ......................................................................................................... 7
instruments with a Part Number
2.3 Test Acceptance.......................................................................................................... 7
of 2088900-xx, 2088900-xx-W,
2.4 Required Documents................................................................................................... 8
2088800-xx (3411) using firmware
2.4.1 Required Documents ............................................................................................. 8
level 4.08.XX or higher
2.5 Optional Documents .................................................................................................... 8
2.5.1 Optional Documents .............................................................................................. 8
3 Installation Qualification Test Procedure ............................................................................ 9
This validation document is approved for use to qualify this instrument 3.1 System Documentation Verification............................................................................. 9
Manufacturer Brand Model Number Serial Number Date Received 3.1.1 System Documentation ........................................................................................ 10
HACH MET ONE 3.2 Utilities Verification .................................................................................................... 11
3.2.1 Power Supply Specifications ................................................................................ 12
3.2.2 Battery Specifications .......................................................................................... 12
This instrument is located at 3.3 Hardware Description/Identification ........................................................................... 13
Customer Name Customer Address Dept or Area 3.3.1 Particle Counter ................................................................................................... 14
3.3.2 Hardware Accessories ......................................................................................... 15
3.4 Software Description/Identification ............................................................................ 16
3.4.1 Installed Software/Firmware................................................................................. 17
3.4.2 Available Optional Software ................................................................................. 17
3.4.3 Optional: FTP Settings ......................................................................................... 18
The key department or individual responsible for this instrument
3.5 Calibration Verification .............................................................................................. 19
Name Department Phone Number Email 3.5.1 Calibration Certification ........................................................................................ 20
3.5.2 Calibration Verification ......................................................................................... 21
3.6 Preventive Maintenance Procedures......................................................................... 22
3.6.1 Preventive Maintenance ...................................................................................... 23
This document is approved for use by the following 3.7 Recommended Spare Parts ...................................................................................... 24
3.7.1 Recommended Spare Parts List .......................................................................... 25
Name Signature Initials Title Company Date
4 Operation Qualification ..................................................................................................... 26
4.1 Operator Interface Verification .................................................................................. 26
4.1.1 Screen Navigation ................................................................................................ 27
4.2 System Security ........................................................................................................ 52
4.2.1 User Roles and User IDs ..................................................................................... 53
4.2.2 Security Verification (Administrator Level Logged On) ......................................... 54
4.2.3 Security Verification (No User Logged On) .......................................................... 60

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4.2.4 Security Verification (Operator Level Logged On)................................................ 62 5.10.1 Testing Option: RS232 Port Operation ........................................................... 174
4.3 Group Settings .......................................................................................................... 64 5.11 Option: Sample Comments ..................................................................................... 177
4.3.1 Group Settings ..................................................................................................... 68 5.11.1 Testing Option: Sample Comments ................................................................ 179
4.4 Operating Modes ....................................................................................................... 73 5.12 Option: Data Export ................................................................................................ 184
4.4.1 Auto Mode............................................................................................................ 74 5.12.1 Testing Option: Data Export, USB .................................................................. 186
4.4.2 Manual Mode ....................................................................................................... 77 5.12.2 Testing Option: Data Export, FTP ................................................................... 195
4.4.3 Beep Mode........................................................................................................... 78 6 Discrepancies ................................................................................................................. 199
4.4.4 Test Wizard Data: Averages ................................................................................ 82 7 Approval of Completed Protocol ..................................................................................... 200
4.4.5 Test Wizard Data: EU GMP ................................................................................. 85 8 References ..................................................................................................................... 201
4.4.6 Test Wizard Data: ISO 14644-1 ........................................................................... 88 9 Appendices ..................................................................................................................... 202
4.5 Test Wizard Verification ............................................................................................ 91
4.5.1 Print Averages Report Data Calculations ............................................................. 93
4.5.2 ISO 14644-1 Report Verification .......................................................................... 94
4.5.3 EU GMP Report Verification ................................................................................ 98
4.6 Optional: USB Data Download Verification ............................................................. 100
4.6.1 USB Data Download Verification ....................................................................... 101
4.6.2 USB Data Verification ........................................................................................ 102
4.7 Alarm Testing .......................................................................................................... 105
4.7.1 Alarm Testing ..................................................................................................... 106
4.8 Power Failure and Recovery Testing ...................................................................... 111
4.8.1 Response to Power Loss ................................................................................... 112
5 Tests for Certain Options................................................................................................ 117
5.1 Option: User Selectable Size Channels .................................................................. 118
5.1.1 Option: User Selectable Channels ..................................................................... 119
5.2 Option: RH/T Sensor ............................................................................................... 122
5.2.1 Option: RH/T Sensor .......................................................................................... 123
5.3 Option: Network Connection ................................................................................... 128
5.3.1 Option: Wired Ethernet Connection ................................................................... 129
5.3.2 Option: Wired Serial [RS-485] Connection ......................................................... 131
5.3.3 Option: Wireless Ethernet Connection ............................................................... 132
5.4 Option: Filter Scan Probe Operation ....................................................................... 135
Option: Filter Scan Probe Setup ..................................................................................... 136
5.5 Option: FS209E & BS5295 Reports ........................................................................ 137
5.5.1 Obtaining Sample Data for Tests ....................................................................... 139
5.5.2 FS 209E Report Verification............................................................................... 146
5.5.3 BS5295 Report Verification ................................................................................ 150
5.6 Option: Partial Data Capture ................................................................................... 152
5.6.1 Testing Option: Partial Data Capture ................................................................. 153
5.7 Option: Alarm Reasons ........................................................................................... 156
5.7.1 Testing Option: Alarm Reasons ......................................................................... 157
5.8 Option: Batch ID ...................................................................................................... 160
5.8.1 Testing Option: Batch ID entry ........................................................................... 161
5.9 Option: PDF/Excel Real-time USB Data Output ...................................................... 164
5.9.1 Option: PDF/EXCEL Real-time USB Data Output ................................................. 167
5.10 RS232 port operation .............................................................................................. 172

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1 Preface 1.5 Protocol User Responsibilities and SignaturesVerifier Responsibilities
This document is a Protocol to generate the necessary data to verify the installation and operation of the The responsibilities of the Verifier are as follows:
MET ONE 3400 Series Particle Counters. The Protocol is divided into two major sections. x Execute this Protocol
x Provide test data for review upon request by customer
1.1 Installation Qualification Purpose x Analyze and compile data into the summary report
To verify that the MET ONE 3400 Series Particle Counter received is identified in the purchase
documents, properly unpacked, installed and ready for operation. From this point forward the unit will be 1.5.2 Customer Responsibilities
referred to as the MET ONE 3400.
The responsibilities of the Customer are as follows:
1.2 Operation Qualification Purpose x Supply all relevant documentation, standard operating procedures, manuals, drawings and
To qualify the operation of the MET ONE 3400 by testing the mechanical and software/firmware schematics necessary for the completion of this Protocol
components of the particle counter and verify its operation to provide evidence that the particle counter x Provide personnel when necessary to assist in operation of the particle counter for the
performs according to the manufacturer’s specifications. completion of this Protocol
x Review and approve this Protocol and the final summary report
1.3 Disclosures
The material in this publication is for informational purposes only. The contents and the product it 1.5.3 Signature Log
describes are subject to change without notice. HACH makes no representations or warranties with
respect to this document. In no event shall HACH be held liable for any damages, direct or incidental,
arising out of or related to the use of this document. Signatures indicate the intent, authority, and ability to complete all qualification tasks.
This Protocol is to be used with the appropriate Operator or User Manual for the MET ONE 3400 Series.
Name Signature Initials Title Company Date
1.4 Revision History

Revision Date of Release


Edition 1 September 2005
Edition 2 May 2006
Edition 3 November 2007
Edition 4 March 2009
Edition 5 May 2009
Edition 5.1 June 2009
Edition 5.2 December 2009
Edition 5.2.1 February 2010
Edition 5.2.2 March 2010
Edition 6.0 April 2010
Edition 6.1 November 2011
Edition 6.2 March 2012
Edition 6.3 May 2012
Edition 6.4 August 2012
Edition 6.5 June 2013

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2 Procedure Guidelines 2.4 Required Documents
The Installation and Operational Qualification Protocol will be executed by physically observing This section lists all documents required to execute this Protocol. Assemble these documents
and operating the particle counter and any associated equipment, comparing observations and and instruments before executing the Protocol.
operations to the relevant documentation (operator manual, etc.) for intended performance and
2.4.1 Required Documents
documenting the results on the attached data sheets.

Name Publisher
This document does not address requirements for systems and/or components that are
networked to the particle counter, such as distributed control systems (DCS), remote alarm User Manual MET ONE 3400 Series Hach
devices, programmable logic controllers (PLC) and/or supervisory control and data acquisition Calibration Certificate
(SCADA) systems. Copy of Purchase Order
Copy of Shipping/Receiving Documents

2.1 Test Execution


Only personnel authorized in the Signature Log (1.5.3) of this Protocol may collect, comment
on and/or review data.
2.5 Optional Documents
All data and comments shall be entered, dated and initialed in ink by the person who is Use this section to list optional documents to execute this Protocol. Assemble these
collecting, commenting on, and/or reviewing information. Entry errors shall be corrected by documents and instruments before executing the Protocol.
drawing a single line through the incorrect information and initialing and dating the entry. All
data shall be recorded “as found” at the time of task execution. If any discrepancies occur, the 2.5.1 Optional Documents
executor will complete the Discrepancies Log (6), including corrective actions taken.
Name Publisher
2.2 Pass/Fail Criteria
ISO 21501 Calibration Certificate
Test functions that meet the specified criteria (Pass) shall be indicated with the word “Pass”
while test functions not meeting the specified criteria (Fail) shall be so indicated with the word
“Fail” in the appropriate column. All test functions must be marked Pass, Fail, or N/A (not
applicable).

2.3 Test Acceptance


After completion of the data sheets, a reviewer other than the person(s) executing the test
functions will review for completeness and ensure all acceptance criteria are met.

This Protocol is complete when all discrepancies within the Protocol have been resolved and
corrective actions have been implemented. The “Approval of Completed Protocol” (7) section
is then signed by all signatories to indicate agreement that all acceptance criteria have been
met and all discrepancies have been resolved with appropriate corrective action.

A final report will be generated once this Protocol has been executed and corrective actions
completed. A summary of the results obtained will be compiled and a conclusion drawn based
on these results.

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3 Installation Qualification Test Procedure 3.1.1 System Documentation

3.1 System Documentation Verification Document Type Unique Identifying Number File Location Quantity Initial Date
User Manual MET ONE 3400
Series
Purpose:
The purpose of this section is to identify the filing location of the MET ONE 3400
documentation.
Calibration Certificate
Execution Materials, Documents, and Instruments:
Not Applicable for this test procedure.
Purchase Order
Test Setup:
None.

Test Method: Shipping/Receiving


1. Perform an inspection of the MET ONE 3400 system’s documentation. Documents
2. Document the filing location of each item listed in section 3.1.1 System Documentation.
3. Where applicable, document the unique identifying number. If a document does not have
a unique identifying number, write N/A in the appropriate section.

Acceptance Criteria:
1. The filing location of the MET ONE 3400 documentation has been identified. List any observed deviations or comments.

Reviewed By: Date:

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3.2 Utilities Verification 3.2.1 Power Supply Specifications

Purpose: Parameter Specified Actual


The purpose of this verification is to document the power requirements for the AC to DC power
Power Supply Manufacturer Record Brand Name
converter and the type of battery(s) utilized by the MET ONE 3400.
Part Number Record Part Number
Execution Materials and Documentation Required: Model Number Record Model Number
1. The AC to DC power converter supplied with the unit.
Input Voltage 100 to 240 VAC As Specified Deviation
2. AC power cord for converter
3. System battery (or batteries) Test Completed by: Date:
4. Copy of Purchase Order
List any observed deviations or comments.

Test Setup:
None.

Test Method:
1. Complete section 3.2.1 Power Requirements and section 3.2.2 Battery Specifications.
Actual data values entered in the sections should be taken directly from the hardware
labels. Reviewed By: Date:

Acceptance Criteria:
1. Actual is equivalent to Specified as defined in section 3.2.1 Power Requirements and 3.2.2 Battery Specifications
section 3.2.2 Battery Specifications.
Parameter Specified Actual

Battery Manufacturer Record Brand Name

Model Number Record Model Number

Output Voltage 14.4 VDC As Specified Deviation

Number of Batteries Verify Against


Supplied Purchase Order

Test Completed by: Date:

List any observed deviations or comments.

Reviewed By: Date:

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3.3 Hardware Description/Identification 3.3.1 Particle Counter

Purpose: Actual from Actual from


Parameter Specified
Rear Panel or Label Printout
The purpose of this section is to verify and document that the MET ONE 3400 and any
purchased accessories match the criteria specified in the purchase order. Model number from
Unit Model Number
rear panel
Execution Materials, Documents and Instruments:
Serial number from
1. Copy of Purchase Order for MET ONE 3400 Unit Serial Number
rear panel
2. User Manual MET ONE 3400 Series
3. Copy of Checklist from Accessory Kit Additional Identifying Company ID or
N/A
Number Asset Tag Number
Test Setup: Test Completed by: Date:
1. Set up the MET ONE 3400 on an appropriate work surface and connect the power
supply. List any observed deviations or comments.

Test Method:
1. Verify the unit’s Model and Serial Numbers from the rear panel of the instrument.
2. Connect the AC power supply; turn unit on.
3. Follow procedures under “Configuration” in Operator Manual.
4. On the Counter Navigation screen, touch the Factory icon.
5. Log on as an ADMINISTRATOR by setting admin as User Name and setting Password Reviewed By: Date:
to 123456.
6. Print a copy of the Factory Settings using the Printer icon in the lower right corner.
Attach the printout to this test section.
7. Print a second copy of the Factory Settings; set aside for use in Section 3.5
8. Return to the Counter Navigation screen using the Return (bent arrow) icon at the
bottom of the screen.
9. Document the model number, serial number and any other unique identifying number in
section 3.3.1 Particle Counter.
10. For items or parameters that have not been specified (“Not Specified”) record the actual
information (or N/A if not applicable) from the installed system components in the “Actual”
column of section 3.3.2 Hardware Accessories.
11. Document additional information where appropriate.
12. For component information not obtained through direct observation of the hardware or
via the operator interface, note in the Comments section how the information was
obtained, and attach copies of the information source used.

Acceptance Criteria:
1. Actual is equivalent to Specified.

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3.3.2 Hardware Accessories 3.4 Software Description/Identification

Description Parameter Specified Actual Purpose:


Included The purpose of this section is to document the Software and Firmware Versions for the MET
Battery Battery 1 each As Specified Deviation
ONE 3400 unit and any additional software provided for data collection and control of the unit.

Isokinetic probe Accessory 1 each As Specified Deviation


Execution Materials, Documents, and Instruments:
Tubing for isokinetic probe Accessory 1 each As Specified Deviation 1. User Manual MET ONE 3400 Series
AC power cord Accessory (1)110 VAC;
As Specified Deviation
(1) 220 VAC Test Setup:
AC/DC converter Accessory 1 each As Specified Deviation None.
Printer Paper Accessory 2 each As Specified Deviation
Test Method:
Zero count filter Accessory 1 each As Specified Deviation 1. From the Counter Navigation screen, select the Diagnostics icon to go to System
Stylus for touch screen Accessory 1 each As Specified Deviation Diagnostics screen to determine the Software and Firmware Versions supplied on the
unit using the User Manual MET ONE 3400 Series.
Flash Memory [USB] Drive Accessory 1 each As Specified Deviation 2. Document the Software Version (Version: #.##.###), the Operating System Version
Nozzle Cleaning Brush Accessory 1 each As Specified Deviation (OS:#.##.##.#) and Firmware Version (CC: ###) in section 3.4.1 Installed
Software/Firmware.
User Manual Manual 1 each As Specified Deviation
3. Return to the Counter Navigation screen. Select the Network icon. The Ethernet MAC
Purchased address is located on the Ethernet tab.
4. Perform an inspection of the optional software supplied with the unit. Commonly this will
be the PortAll software CD but other software may have been provided and should be
recorded here.

Acceptance Criteria:
1. The actual Software and Firmware Versions are documented in section 3.4.1 Installed
Test Completed by: Date: Software/Firmware and any optional software in section 3.4.2 Available Software.
List any observed deviations or comments.

Received by: Date:

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3.4.1 Installed Software/Firmware

MET ONE 3400 Installed 3.4.3 Optional: FTP Settings


Parameter Specified Actual
Software/Firmware
Firmware Version 04.07.00 or higher The settings noted below are needed only when the FTP server data transfer function is in use at your
facility. The values to be entered below would normally be supplied by your facility’s IS/IT department.
Operating Software OS: 5.00.54 or higher Some values will be global – used for all Met One 3400 instruments – and certain values, such as the
IP address and user logon, will be unique for each particle counter. In order to change the FTP setup
Firmware, Core Counter CC: 309 or higher values, the user needs to have System Admin enabled under Access Rights (or have User Logon
Required disabled). To simply view the settings needed for the list below, the user only needs Export
enabled under Access Rights.
Ethernet, wired MAC address As displayed on
NETWORK >
These values will be found under the EXPORT icon by pressing the Configure FTP button at the
Ethernet tab
bottom of the Export Sample Data screen.; the Network Server Enabled box needs to be checked to
Test Completed by: Date: enter values;
List any observed deviations or comments.

FTP Settings Specified Actual

Host/IP Address:

Port:

Protocol:
Reviewed By: Date:
Initial Folder:

Authentication:
3.4.2 Available Optional Software
User Name:

Available Software Password:


Parameter Specified Actual
Description
PortAll Version 2 PN 2087090
Test Completed by: Date:

Test Completed by: Date: List any observed deviations or comments.

List any observed deviations or comments.

Reviewed By: Date:

Reviewed By: Date:

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3.5.1 Calibration Certification
3.5 Calibration Verification
Certificate of
Purpose: Parameter MET ONE 3400 Memory/Specified Pass /Fail
Calibration
The purpose of this verification is to document that the MET ONE 3400 is properly calibrated,
the calibration is current and that the information contained in the system’s memory matches Calibration
Pass Fail
Date
the calibration certificate.

Calibration Due Pass Fail


Execution Materials and Documentation Required:
1. Copy of the current Certificate of Calibration for the unit.
Is today’s date between the Today’s date is between the
2. User Manual MET ONE 3400 Series Calibration Date and the Calibration Calibration Date and the Calibration
Pass Fail
Due date? Due date
Test Setup:
Test Completed by: Date:
None.
List any observed deviations or comments.
Test Method:
1. Use the instructions in the MET ONE 3400 User Manual to access Factory Settings.
Verify the unit’s calibration date and calibration due date from its memory.
2. Attach a copy of the FACTORY SETTINGS printout to this test section.
3. Record the calibration date and calibration due date from the FACTORY SETTINGS
printout and the Certificate of Calibration in section 3.5.1 Calibration Certification.
4. Record and compare the Channel Sizes and Thresholds from the Certificate of Reviewed By: Date:
Calibration with the values from the second FACTORY SETTINGS printout saved from
section 3.3.

Note: There may be some threshold values recorded in “volts” and some in “millivolts”, depending on the
software or instrument. This difference in the presentation of the data is not a cause for a deviation or
rejection. Example: a threshold voltage may be presented both as “42 millivolts” and as “0.042 volts”.
Electronically, these values are equal.

Acceptance Criteria:
1. The calibration dates contained within the system’s memory match the dates from the
Certificate of Calibration. The current date is within the range recorded.
2. Attach a copy of the Certificate of Calibration and all generated printouts to this Protocol.

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3.5.2 Calibration Verification
3.6 Preventive Maintenance Procedures
Note: In many cases, fewer than 12 Thresholds will be used. Mark extraneous Size Thresholds as “n/a” if not
used. Purpose:
Note: There may be some threshold values recorded in “volts” and some in “millivolts”, depending on the software The purpose of this section is to identify the preventive maintenance procedures for the MET
or instrument. This difference in the presentation of the data is not a cause for a deviation or rejection. Example:
a threshold voltage may be presented both as “42 millivolts” and as “0.042 volts”. Electronically, these values are
ONE 3400.
equal.
Execution Materials, Documents, and Instruments:
Customer Standard Operating Procedures
Certificate of
Parameter MET ONE 3400 Memory Pass /Fail
Calibration Test Setup:
Size Threshold Size Threshold Pass Fail None.
Size 1 Pass Fail
Test Method:
Size 2 Pass Fail 1. Review the MET ONE 3400’s recommended preventive maintenance procedures contained
Size 3 Pass Fail
in your company’s standard operating procedures.
2. Determine if these preventive maintenance procedures have been created in the
Size 4 Pass Fail appropriate PM system.
Size 5 Pass Fail 3. Where applicable document the procedure numbers and effective dates. If a document
does not exist, N/A the appropriate section.
Size 6 Pass Fail

Size 7 Pass Fail Acceptance Criteria:


1. The preventive maintenance procedures for the MET ONE 3400 have been identified and
Size 8 Pass Fail
documented as applicable.
Size 9 Pass Fail

Size 10 Pass Fail

Size 11 Pass Fail

Size 12 Pass Fail

Test Completed by: Date:

List any observed deviations or comments.

Reviewed By: Date:

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3.6.1 Preventive Maintenance 3.7 Recommended Spare Parts

Maintenance Purpose:
Frequency PM Number Effective Date
Procedure The purpose of this section is to identify the recommended spare parts for the MET ONE 3400
Purging the counter Daily or at an and document the quantity of each delivered with the unit.
with a zero count appropriate
filter frequency Execution Materials, Documents, and Instruments:
Charging the Daily or at an 1. User Manual MET ONE 3400 Series
battery appropriate 2. Copy of the purchase order.
frequency

Test Setup:
None.

Test Method:
1. Review the spare parts list in section 11 of the User Manual.
2. Determine which (if any) parts were purchased with the system by reviewing the copy of
the purchase order.

Test Completed by: Date:


Acceptance Criteria:
1. The spare parts for the MET ONE 3400 have been identified and the actual parts
List any observed deviations or comments. delivered with the unit have been compared against the purchase order.

Reviewed By: Date:

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3.7.1 Recommended Spare Parts List
4 Operation Qualification
Recommended Quantity or Specified in 4.1 Operator Interface Verification
Spare Part Item Quantity on Hand
Purchase Order

Spare Battery Purpose:


This section verifies the operator interface with the MET ONE 3400 by testing the navigation of
External Battery Charger screens.

2-roll Pack of Thermal Execution Materials, Documents, and Instruments:


Paper 1. Met One 3400 Particle Counter
2. User Manual MET ONE 3400 Series
USB Flash Drive 3. One or more rolls of printer paper
4. Zero count filter
Zero Count Filter
Test Setup:
Isokinetic Probe stand, Note:
Heavy Duty, Stainless
Steel When there is a possibility to enable or disable a function on the particle counter, the
presence of a checkmark 9 within the adjacent box ; indicates that the function is
ENABLED; an empty box … indicates the function is DISABLED.
Isokinetic Probe, Light
Duty
1. Verify that the power supply is properly set up and connected.
Test Completed by: Date: 2. Unit is powered on.
List any observed deviations or comments.
3. Verify that at least one battery is installed. The green light for Battery status (below the
Power button) may blink if the battery or batteries are not at full charge. The Battery status
LED should be a steady green light when the installed battery or batteries are fully charged.
Note: These tests can be conducted whether charging is in progress or completed.
4. Verify that the printer has a roll of paper installed with at least half a roll of unused paper
remaining.
5. Check the Counter Navigation>System>System Settings screens to confirm that the 3400
has been configured so a) no user login is required, b) values for Date and Time are set
Reviewed By: Date: correctly, c) Sleep Time and Backlight Timeout are set to 0, d) that the language for
display is English, e) that no sound parameters are set to None and f) that the volume is
set to an audible level.
6. Press the Return icon followed by selecting the Sample icon to go to the Sample Screen.
7. Install the zero-count filter on sample inlet if not already in place.

Test Method:
1. Execute the test scripts in section 4.1.1 Screen Navigation and record all the Actual results.

Acceptance Criteria:
1. Actual is equivalent to Specified.
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Test Action Specified Actual Pass/Fail
4.1.1 Screen Navigation
13. Select the Users tab on The System Settings
the System Settings screen is displayed with the As Specified Deviation Pass Fail
Test Action Specified Actual Pass/Fail screen Users tab visible
1. From the current screen, The Counter Navigation 14. Select user Highlight bar appears in
As Specified Deviation Pass Fail
select the Return (bent screen displays. blue
As Specified Deviation Pass Fail
arrow) icon at the lower left 15. Select Edit The Manage User Account
corner As Specified Deviation Pass Fail
screen appears
2. Select the System icon The System Settings 16. Select the User Name The screen does not
screen displays with the field change. An error tone As Specified Deviation Pass Fail
As Specified Deviation Pass Fail
Options and Accessories tab sounds
visible
17. Select the Password The Enter Password screen
3. Select the Basic tab, The Enter Current Time As Specified Deviation Pass Fail
As Specified Deviation Pass Fail field appears
then Time field screen appears
18. Select Cancel The Manage User Account
4. Select Cancel and then The Enter Current Date As Specified Deviation Pass Fail
As Specified Deviation Pass Fail screen appears
select the Date field screen appears
19. Select the Access The screen changes to
5. Select Cancel and then The Enter Sleep Time Rights tab display the Access Rights As Specified Deviation Pass Fail
As Specified Deviation Pass Fail
the Sleep Time field screen appears tab
6. Select Cancel and then The Enter Backlight Time 20. Select Cancel button The System Settings
select the Backlight screen appears As Specified Deviation Pass Fail As Specified Deviation Pass Fail
screen is displayed
Timeout field
21. Select the Options and The System Settings
7. Select Cancel and then The System Settings Accessories tab on the screen is displayed with the
select the Sounds tab screen is displayed with the As Specified Deviation Pass Fail As Specified Deviation Pass Fail
System Settings screen Options and Accessories tab
Sounds tab visible visible
8. Select asterisk from 22. Select Clear Buffer The Clear Sample Buffer
the User Feedback Asterisk is selected As Specified Deviation Pass Fail As Specified Deviation Pass Fail
popup opens
dropdown menu
23. Select Yes Popup display closes and
9. Select default from the the value listed for Data As Specified Deviation Pass Fail
Default is selected As Specified Deviation Pass Fail
Stop Error dropdown menu Buffer is “0”
10. Select critical from the 24. Select the Data Buffer The Enter Buffer Size
Critical is selected As Specified Deviation Pass Fail As Specified Deviation Pass Fail
Warning dropdown menu Size field screen appears
11. Select LoudBeep from 25. Enter value of 5000, A message box Set Sample
the Alarm Limit dropdown LoudBeep is selected As Specified Deviation Pass Fail As Specified Deviation Pass Fail
then select Enter Buffer Size appears
menu
26. Select Yes Message box disappears As Specified Deviation Pass Fail
12. Use the Volume slider Touching the Test icon
and the Test icon to set the produces an audible sound 27. Select English from the English is selected
As Specified Deviation Pass Fail As Specified Deviation Pass Fail
volume at a tolerable Language dropdown box
audible level Test Completed by: Date:
Test Completed by: Date: List any observed deviations or comments.
List any observed deviations or comments.

Reviewed By: Date: Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 27 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 28 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail Test Action Specified Actual Pass/Fail
28. Select the Units and The System Settings 40. Select the checkbox A checkmark appears or
Alarms tab on the screen appears with the next to Store Partial disappears with As Specified Deviation Pass Fail
As Specified Deviation Pass Fail
System Settings screen Units and Alarms tab Data twice consecutive selections.
visible 41. Select 1000 from the 1000 is selected
As Specified Deviation Pass Fail
29. Select Deg C from Deg C is selected Altitude dropdown menu
the Temperature As Specified Deviation Pass Fail
42. Select Air from the Gas Air is selected
dropdown menu dropdown menu
30. Select mm/Sec from mm/Sec is selected Note: Most counters will not have
the Air Velocity dropdown As Specified Deviation Pass Fail alternative gases as optional function. As Specified Deviation Pass Fail
In that case, only Air will be displayed
menu and an ERROR beep will sound when
trying to access other value from the
31. Select LPM from the LPM is selected Gas dropdown menu
As Specified Deviation Pass Fail
Flow Rate dropdown menu
43. From the System Screen changes to
32. In the Flow Rate Alarm A “check” or “tick” mark is Settings>Custom screen, Counter Navigation screen As Specified Deviation Pass Fail
section, verify that the present in the Flow Rate select the Return icon
Enabled field contains a Alarm>Enabled field As Specified Deviation Pass Fail
“check” mark; if not, touch 44. Select the Factory icon The User Logon screen
As Specified Deviation Pass Fail
the empty field appears

33. Verify that the Low and Values are set to -5.00% 45. Log on at the The Factory Settings screen
High fields are set to - and +5.00% As Specified Deviation Pass Fail Administrator level appears
Note: Default logon is User Name As Specified Deviation Pass Fail
5.00% and +5.00% = admin; Password = 123456,
34. Select the checkbox A checkmark appears or followed by the OK button
next to HMP RH/T twice disappears with consecutive As Specified Deviation Pass Fail 46. Select the Counter tab The Factory Settings screen
selections. is displayed with the Counter As Specified Deviation Pass Fail
35. Select the Reasons Screen changes to Enter tab visible
As Specified Deviation Pass Fail
icon Alarm Reason 47. Select the Model field The screen does not
36. Select the Add button Screen changes to Alarm change. An error tone As Specified Deviation Pass Fail
As Specified Deviation Pass Fail sounds
Reasons screen
37. Enter Reason 1, Screen changes to Alarm 48. Select the Serial The screen does not
followed by the Enter Reasons screen, with As Specified Deviation Pass Fail Number field change. An error tone As Specified Deviation Pass Fail
button Reason 1 displayed in list sounds
38. From the Alarm Screen changes to System 49. Select the Calibration The screen does not
Reasons screen, select the Settings screen As Specified Deviation Pass Fail Date field change. An error tone As Specified Deviation Pass Fail
Return icon sounds
39. From the System Screen changes to display 50. Select the Calibration The screen does not
Settings screen, select the Custom tab As Specified Deviation Pass Fail Due field change. An error tone As Specified Deviation Pass Fail
Custom tab sounds
Test Completed by: Date: Test Completed by: Date:
List any observed deviations or comments. List any observed deviations or comments.

Reviewed By: Date:


Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 29 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 30 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail Test Action Specified Actual Pass/Fail
51. Select the Nominal The screen does not 62. Select any one of the The Size value is
Flow field change. An error tone As Specified Deviation Pass Fail Size values highlighted; no other activity As Specified Deviation Pass Fail
sounds occurs
52. Select the Sensor The screen does not 63. Select the Control tab The Factory Settings screen
Serial field change. An error tone As Specified Deviation Pass Fail appears with the Control tab As Specified Deviation Pass Fail
sounds visible
53. Select the HeNe check The screen does not 64. Touch the Main Pump Check mark appears in box;
box change. An error tone As Specified Deviation Pass Fail box the vacuum pump turns ON As Specified Deviation Pass Fail
sounds
54. Select the WiFi The screen does not 65. Touch the Main Pump The box is unmarked; the
Enabled check box change. An error tone As Specified Deviation Pass Fail box vacuum pump turns OFF As Specified Deviation Pass Fail
sounds
66. Touch the Laser Power Check mark appears in box;
55. Select the Calibration The Factory Settings screen
box the Laser Cal. (VDC) value
tab is displayed with the As Specified Deviation Pass Fail increases to value in range Actual Value:_________ Pass Fail
Calibration tab visible of 0.9 to 1.1
Record actual value.
56. Select any one of the The Size and the Threshold
Size values values are highlighted for As Specified Deviation Pass Fail 67. Touch the Laser Power The box is unmarked; the
that size box Laser Cal. (VDC) value
decreases to value in range Actual Value:_________ Pass Fail
57. Select each one of The screen does not of 0.4 to 0.6
icons on the right side in change. An error tone Record actual value.
As Specified Deviation Pass Fail
turn, with a “+”, “triangle” sounds 68. Model 3411 only: Touch Check mark appears in box;
and “X” symbol the Purge Pump box the purge pump turns ON. As Specified Deviation
Pass Fail
Note: Mark n/a if not Model 3411 N/A
58. Select the The screen does not
Configurable Channels change. An error tone As Specified Deviation Pass Fail
69. Model 3411 only: Touch The box is unmarked; the
check box sounds As Specified Deviation
the Purge Pump box purge pump turns OFF. Pass Fail
59. Select the Test tab The Factory Settings screen Note: Mark n/a if not Model 3411
N/A
is displayed with the Test As Specified Deviation Pass Fail
tab visible 70. Model 3411 only: Touch Check mark appears in box;
the Fan box the fan turns ON. As Specified Deviation
Pass Fail
60. Select the Large The screen does not Note: Mark n/a if not Model 3411 N/A
Increments field, the “+”, “-“ change. An error tone
As Specified Deviation Pass Fail
and Flow Calibration fields sounds 71. Model 3411 only: Touch The box is unmarked; the
in turn the Fan box fan turns OFF. As Specified Deviation
Pass Fail
Note: Mark n/a if not Model 3411
N/A
61. Select the Run The Factory Settings screen
Voltages tab appears with the Run As Specified Deviation Pass Fail 72. Select the Printer icon. Printout marked Factory
Voltages tab visible Settings is generated. As Specified Deviation Pass Fail
Test Completed by: Date:
List any observed deviations or comments. Test Completed by: Date:
List any observed deviations or comments.

Reviewed By: Date:


Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 31 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 32 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail Test Action Specified Actual Pass/Fail
73. Remove the printed Paper tape is saved with 83. Select the Return icon Screen changes to
output and save with this this procedure As Specified Deviation Pass Fail As Specified Deviation Pass Fail
Counter Navigation screen
procedure
74. Select the Return icon The Counter Navigation 84. Select the Locations Screen changes to
As Specified Deviation Pass Fail As Specified Deviation Pass Fail
appears icon Area/Location Setup screen
75. Select the Printer icon. The Print Center screen 85. If one or more Areas The selected Area is
appears As Specified Deviation Pass Fail already exist, touch the highlighted As Specified Deviation Pass Fail
label for the Area
76. Select All from the All is selected
Sample Print Mode As Specified Deviation Pass Fail 86. Select the Remove A pop-up window appears
dropdown menu Area button requiring a YES or NO
As Specified Deviation Pass Fail
77. Select 1-10 from the 1-10 is selected response to execute
Cycle Print Order REMOVE task
dropdown menu
Note: When “1-10” is set for Cycle As Specified Deviation Pass Fail 87. Select the YES button The pop-up window
Print Order during active sampling, Note: If necessary repeat last
disappears; the previously
no printouts occur until end of all
As Specified Deviation Pass Fail
three steps until list is blank. chosen Area is no longer
sample cycles at the current listed.
location.
78. Select the Average Printing message appears 88. When list box is empty, Screen changes to
icon for a moment, then clears; As Specified Deviation Pass Fail
select the Return icon Counter Navigation screen
printout occurs marked As Specified Deviation Pass Fail
“Print Averages” and “No 89. Select the Group icon Screen changes to Group
Data” As Specified Deviation Pass Fail
Setting Management screen
79. Select the Buffer icon Printing message appears
for a moment, then clears; 90. Touch the Default title The Default Group is
As Specified Deviation Pass Fail As Specified Deviation Pass Fail
printout occurs marked highlighted
“No Data”
91. Touch the Load button The words Active Group:
80. Select the Paper Feed Printing message appears
Default are displayed on As Specified Deviation Pass Fail
icon for a moment, then clears; As Specified Deviation Pass Fail
the screen
paper advances
81. Select the Cancel No print activity occurs Test Completed by: Date:
As Specified Deviation Pass Fail
Print icon List any observed deviations or comments.

82. Remove the printed Paper tape is marked as


output messages; mark as PRINTER TEST and saved As Specified Deviation Pass Fail
PRINTER TEST with this Protocol

Test Completed by: Date:


List any observed deviations or comments.

Reviewed By: Date:

Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 33 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 34 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail Test Action Specified Actual Pass/Fail

92. If one or more Groups The selected Group is 99. Select Settings button The Group Settings screen
already exist other than highlighted is displayed with “Default As Specified Deviation Pass Fail
Default, touch the wording Group” in bold.
for one of the Groups other As Specified Deviation Pass Fail
than Default. If no other 100. Select Settings The Sample Setup (Default)
groups exist, skip next two icon near the lower left area screen is displayed with the As Specified Deviation Pass Fail
steps. of the screen General tab open.

93. Select the Delete A pop-up window appears 101. Select the Count The Enter Count Cycles
As Specified Deviation Pass Fail
Cycles field screen is displayed.
button requiring a YES or NO
As Specified Deviation Pass Fail
response to complete 102. Select the number The Sample Setup screen
Delete Group task 3 followed by the Enter key appears and the number “3”
As Specified Deviation Pass Fail
is displayed in the Count
94. Select the YES button The pop-up window Cycles field
Note: If necessary repeat last
disappears; the previously
As Specified Deviation Pass Fail 103. Select Auto from Auto is selected
three steps until only the Default chosen Group is no longer
and <New> are shown on list. listed. the Run Mode dropdown As Specified Deviation Pass Fail
menu.
95. Highlight the Default The selected Group is 104. Select Cumulative Cumulative is selected
group highlighted As Specified Deviation Pass Fail from the Count Display As Specified Deviation Pass Fail
dropdown menu
105. Select Counts Counts is selected
96. Select the Delete A pop-up window appears
from the Count Mode As Specified Deviation Pass Fail
button requiring a YES or NO
As Specified Deviation Pass Fail dropdown menu
response to complete
Delete Group task 106. Select the Timing The Sample Setup (Default)
tab on the Sample Setup screen appears with the As Specified Deviation Pass Fail
97. Select the YES button A new message pop-up screen Timing tab visible
appears stating “Active As Specified Deviation Pass Fail
Group cannot be deleted” 107. Select the Sample The Enter Sample Time
As Specified Deviation Pass Fail
Time field screen appears
98. Click on the OK button Message window 108. Enter “000006” and The Sample Setup>Timing
disappears and the Group then the Enter key screen appears and
Setting Management screen As Specified Deviation Pass Fail
As Specified Deviation Pass Fail “00:00:06” is the value in
is displayed with the Default the Sample Time field
group denoted as the Active
Group. 109. Select the Hold The Enter Hold Time screen
Time field appears As Specified Deviation Pass Fail
Test Completed by: Date:
List any observed deviations or comments. Test Completed by: Date:
List any observed deviations or comments.

Reviewed By: Date:


Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 35 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 36 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail Test Action Specified Actual Pass/Fail
110. Enter “000008” and The Sample Setup>Timing 120. Enter “50” and then The Alarm Settings screen
then the Enter key screen appears and the Enter key appears and “50” is the
As Specified Deviation Pass Fail As Specified Deviation Pass Fail
“00:00:08” is the value in value in the Count Limit field
the Hold Time field for the second size
111. Select the Delay The Enter Delay Time 121. Again, touch the Size label and associated
As Specified Deviation Pass Fail
Time field screen appears first value underneath Size Count and Concentration
As Specified Deviation Pass Fail
112. Enter “000010” and The Sample Setup>Timing Limit values are
then the Enter key screen appears and highlighted
As Specified Deviation Pass Fail
“00:00:10” is the value in 122. Touch the EDIT The Enter Concentration
the Delay Time field button under the Conc. Limit screen appears As Specified Deviation Pass Fail
Limit column
113. Select the Return Screen changes to Group As Specified Deviation Pass Fail
icon Settings screen 123. Enter “2000” and The Alarm Settings screen
then the Enter key appears and “2000” is the
114. Select Alarms icon The Alarm Settings screen is As Specified Deviation Pass Fail
value in the Conc. Limit field
near the lower right area of displayed with the Count tab As Specified Deviation Pass Fail for the first size
the screen open.
124. Again, touch the Size label and associated
115. Touch the first Size label and associated second value underneath Count and Concentration
value underneath Size Count and Concentration As Specified Deviation Pass Fail
As Specified Deviation Pass Fail Size Limit values are
(example “0.50”) Limit values are highlighted
highlighted
125. Touch the EDIT The Enter Concentration
116. Touch the EDIT The Enter Count Limit button under the Conc. Limit screen appears As Specified Deviation Pass Fail
button under the Count screen appears As Specified Deviation Pass Fail Limit column
Limit column
126. Enter “1000” and The Alarm Settings screen
117. Enter “100” and The Alarm Settings screen then the Enter key appears and “1000” is the
then the Enter key appears and “100” is the As Specified Deviation Pass Fail
As Specified Deviation Pass Fail value in the Conc. Limit field
value in the Count Limit field for the second size
for the first size
127. Select the Return Screen changes to Group
118. Touch the second Size label and associated As Specified Deviation Pass Fail
icon Settings screen
value underneath Size Count and Concentration
As Specified Deviation Pass Fail 128. Select the Return Screen changes to Group
Limit values are As Specified Deviation Pass Fail
highlighted icon Setting Management screen
119. Touch the EDIT The Count Limit screen 129. Select the SAVE A message screen appears
button under the Count appears button to confirm intent to As Specified Deviation Pass Fail
As Specified Deviation Pass Fail overwrite
Limit column
130. Select the YES Message Screen
Test Completed by: Date: button disappears; screen returns
As Specified Deviation Pass Fail
List any observed deviations or comments. to Group Setting
Management screen
Test Completed by: Date:
List any observed deviations or comments.

Reviewed By: Date: Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 37 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 38 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail Test Action Specified Actual Pass/Fail

131. Select the PRINT Printout entitled Group 135. Compare REPORT Displayed values matches
As Specified Deviation Pass Fail display to values set values set
icon near the lower right Settings is generated PERIOD __________
Note: Some labels are abbreviated
132. Printout matches set values in this Protocol in order to fit into PERIOD 00:00:06 HOLD __________
Compare printout to values below this column space; PASS is to be
HOLD 00:00:08 DELAY __________
set PERIOD __________ determined solely on matching
values for variable entries, not on DELAY 00:00:10 GROUP NAME __________
Note: Some labels are abbreviated PERIOD 00:00:06 HOLD __________ labels or titles.
in this Protocol in order to fit into GROUP NAME Default CYCLES __________
this column space; PASS is to be HOLD 00:00:08 DELAY __________
CYCLES 003 DATA DPLY __________
determined solely on matching DELAY 00:00:10 GROUP NAME __________
values for variable entries, not on DATA DPLY Cumulative COUNT SCALE __________
labels or titles. GROUP NAME Default CYCLES __________
COUNT SCALE Counts RUN MODE __________
CYCLES 003 DATA DPLY __________ Pass Fail
RUN MODE Auto PRINT MODE __________
DATA DPLY Cumulative COUNT SCALE __________
PRINT MODE All PRINT CY.COUNT __________
COUNT SCALE Counts RUN MODE __________
PRINT MODE __________ PRINT CY.COUNT 001 Count Limit, Ch 1 __________
RUN MODE Auto Pass Fail
PRINT CY.COUNT __________ Count Limit, Ch 1 100 Count Limit, Ch 2 __________
PRINT MODE All
Count Limit, Ch 2 50 Conc. Limit, Ch. 1 __________
PRINT CY.COUNT 001
Count Limit, Ch 1 __________ Conc. Limit, Ch. 1 2000 Conc. Limit, Ch. 2 __________

Count Limit, Ch 1 100 Count Limit, Ch 2 __________ Conc. Limit, Ch. 2 1000 Flow, Low __________
Count Limit, Ch 2 50 Conc. Limit, Ch. 1 __________ Flow, Low 5 Flow, High __________
Conc. Limit, Ch. 1 2000 Conc. Limit, Ch. 2 __________ Flow, High 5
Conc. Limit, Ch. 2 1000 136. Select the OK Display returns to Group
As Specified Deviation Pass Fail
Flow, Low __________ button Setting Management screen
Flow, Low 5.00 Flow, High __________
137. Select the Return Screen changes to As Specified Deviation Pass Fail
Flow, High 5.00 icon Counter Navigation screen

133. Remove printout 138. Select the The Area/Location Setup


As Specified Deviation Pass Fail
from printer; mark as Printout is marked as Locations icon screen appears
As Specified Deviation Pass Fail
“Default Group”; attach to “Default Group” and saved 139. Touch the Add The Enter Area Name
Protocol Area button screen appears As Specified Deviation Pass Fail

134. Select the 140. Use the displayed The Area/Location Setup
REPORT icon [symbolized keypad to enter “Area 1” dialog box is displayed with As Specified Deviation Pass Fail
as sheet of paper in front of Display entitled Group followed by the Enter key “Area 1” displayed
As Specified Deviation Pass Fail
printer] near the lower right Settings is generated 141. Touch the “Area 1” The Area 1 entry is
entry highlighted As Specified Deviation Pass Fail
Note: Use scroll bar to view
complete contents of display.
Test Completed by: Date:
Test Completed by: Date: List any observed deviations or comments.
List any observed deviations or comments.

Reviewed By: Date:


Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 39 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 40 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail Test Action Specified Actual Pass/Fail
142. Select the Add The Sample Location Setup 150. Touch the “Location The Enter Location Name
Location button screen is displayed with no As Specified Deviation Pass Fail
Name” field screen is displayed
entry displayed in the
As Specified Deviation Pass Fail 151. Use the displayed The Sample Location Set
Location Name field and “0”
displayed in the Location ID keypad to enter Location ID Up dialog box is displayed
field “2” in place of “0”, followed with “Location 2” displayed As Specified Deviation Pass Fail
by the Enter key in the Location Name field
143. Touch the “Location The Enter Location Name and “2” displayed in the
As Specified Deviation Pass Fail
Name” field screen is displayed Location ID field
144. Use the displayed The Sample Location Setup 152. Select the Return The Area/Location Setup
keypad to enter “Location 1” screen is displayed with icon screen is displayed with
As Specified Deviation Pass Fail
followed by the Enter key “Location 1” displayed in entries for “Location 1” and
As Specified Deviation Pass Fail “Location 2”
the Location Name field and
“0” displayed in the 153. Touch the “Area 1” “Area 1” is highlighted in
Location ID field entry blue As Specified Deviation Pass Fail
145. Touch the “Location The Enter Location ID
ID” field screen is displayed As Specified Deviation Pass Fail
154. Select the Add The Sample Location Setup
As Specified Deviation Pass Fail
Location button screen is displayed
146. Use the displayed The Sample Location Setup
keypad to enter “1” in place screen is displayed with 155. Touch the “Location The Enter Location Name
of “0”, followed by the Enter “Location 1” displayed in As Specified Deviation Pass Fail
As Specified Deviation Pass Fail Name” field screen is displayed
key the Location Name field and
“1” displayed in the 156. Use the displayed The Sample Location Setup
Location ID field keypad to enter “Location 3” screen is displayed with
followed by the Enter key “Location 3” displayed in
147. Select the Return The Area/Location Setup As Specified Deviation Pass Fail
the Location Name field and
icon screen is displayed with a
As Specified Deviation Pass Fail “0” displayed in the
single entry for “Area
Location ID field
1>Location 1”
148. Touch the “Area 1” “Area 1” is highlighted in 157. Touch the “Location The Enter Location ID
As Specified Deviation Pass Fail
entry blue As Specified Deviation Pass Fail ID” field screen is displayed

158. Use the displayed The Sample Location Setup


149. Select the Add The Sample Location Setup keypad to enter “3” in place screen is displayed with
Location button dialog box is displayed with of “0”, followed by the Enter “Location 3” displayed in
no entry displayed in the As Specified Deviation Pass Fail
As Specified Deviation Pass Fail key the Location Name field and
Location Name field and “0” “3” displayed in the
displayed in the Location ID Location ID field
field
Test Completed by: Date:
Test Completed by: Date:
List any observed deviations or comments.
List any observed deviations or comments.

Reviewed By: Date:


Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 41 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 42 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail Test Action Specified Actual Pass/Fail
159. Select the Return The Area/Location Setup 169. Enter “60” and then The Alarm Settings screen
icon screen is displayed with the Enter key appears and “60” is the
As Specified Deviation Pass Fail
entries for “Location 1”, As Specified Deviation Pass Fail value in the Count Limit field
“Location 2”, and “Location for the first size
3”
170. Touch the white Size label and associated
160. Touch the “Location “Location 1” is highlighted in field next to the second Count and Concentration
As Specified Deviation Pass Fail As Specified Deviation Pass Fail
1” entry blue value underneath Size Limit values are
highlighted
161. Select the Edit The Sample Location Setup
As Specified Deviation Pass Fail 171. Touch the EDIT The Enter Count Limit
Location button dialog box is displayed
button under the Count screen appears As Specified Deviation Pass Fail
162. Touch the Settings The Sample Setup (Location Limit column
icon 1) screen appears with As Specified Deviation Pass Fail
General tab displayed 172. Enter “30” and then The Alarm Settings screen
the Enter key appears and “30” is the
163. Touch the Count The Enter Count Cycles As Specified Deviation Pass Fail
As Specified Deviation Pass Fail value in the Count Limit field
Cycles field. screen is displayed for the second size
164. Use the displayed The Sample Setup (Location 173. Touch the white Size label and associated
keypad to enter “1” followed 1) screen is displayed with field next to the first value Count and Concentration
As Specified Deviation Pass Fail As Specified Deviation Pass Fail
by the Enter key “1” displayed in the Count underneath Size (example Limit values are
Cycles field. “0.5”) highlighted
174. Touch the EDIT The Enter Concentration
165. Select the Return The Sample Location Setup
As Specified Deviation Pass Fail button under the Conc. Limit screen appears As Specified Deviation Pass Fail
icon screen is displayed
Limit column
166. Select Alarms icon The Alarm Settings screen is
near the lower right area of displayed with the Count tab As Specified Deviation Pass Fail 175. Enter “5000” and The Alarm Settings screen
the screen open. then the Enter key appears and “5000” is the
As Specified Deviation Pass Fail
value in the Concentration
167. Touch the white Size label and associated Limit field for the first size
field next to the first value Count and Concentration
As Specified Deviation Pass Fail 176. Touch the white Size label and associated
underneath Size (example Limit values are
“0.5”) highlighted field next to the second Count and Concentration
As Specified Deviation Pass Fail
value underneath Size Limit values are
168. Touch the EDIT The Enter Count Limit highlighted
button under the Count screen appears As Specified Deviation Pass Fail
Limit column 177. Touch the EDIT The Enter Concentration
button under the Conc. Limit screen appears As Specified Deviation Pass Fail
Test Completed by: Date: Limit column
List any observed deviations or comments. Test Completed by: Date:
List any observed deviations or comments.

Reviewed By: Date: Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 43 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 44 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail Test Action Specified Actual Pass/Fail
178. Enter “2500” and The Alarm Settings screen 187. Select the Return The Sample Location Setup
then the Enter key appears and “2500” is the icon screen is displayed As Specified Deviation Pass Fail
value in the Concentration As Specified Deviation Pass Fail
Limit field for the second 188. Select the Return The Area/Location Setup
As Specified Deviation Pass Fail
size icon screen is displayed

179. Select the The Alarm Settings screen 189. Touch the text for Text for Location 1 is
Location 1 highlighted As Specified Deviation Pass Fail
Environmental tab on the appears with the
As Specified Deviation Pass Fail
Alarm Settings screen Environmental tab visible
columns 190. Select the PRINT Printout entitled Location
icon near the lower right Settings is generated for As Specified Deviation Pass Fail
180. Verify that there are All three Enabled boxes are Location 1
no “check” or “tick” marks in empty
any of the three Enabled As Specified Deviation Pass Fail 191. Remove printout Printout is marked and
and mark as Location 1A retained for next steps. As Specified Deviation Pass Fail
boxes; if any are, clear the
box by touching it.
192. Touch the text for Text for Location 2 is
Location 2 highlighted As Specified Deviation Pass Fail
181. One by one, select No screen activity takes
the six larger white fields in place; an audible sound
As Specified Deviation Pass Fail 193. Select the PRINT Printout entitled Location
the Low and High columns plays each time a selection
is attempted icon near the lower right Settings is generated for As Specified Deviation Pass Fail
Location 2
182. In the row for A “check” or “tick” mark
Temperature, select appears in the chosen As Specified Deviation Pass Fail 194. Remove printout Printout is marked and
and mark as Location 2A retained for next steps. As Specified Deviation Pass Fail
Enabled Enabled box
183. Select the Low field The Enter Temperature Low 195. Touch the text for Text for Location 3 is
As Specified Deviation Pass Fail As Specified Deviation Pass Fail
for Temperature Limit screen appears Location 3 highlighted
184. Enter “18” and then The Alarm Settings screen 196. Select the PRINT Printout entitled Location
the Enter key appears and “18.0” is the icon near the lower right Settings is generated for As Specified Deviation Pass Fail
As Specified Deviation Pass Fail
value displayed in the Low Location 3
field for Temperature
197. Remove printout Printout is marked and
185. Select the High The Enter Temperature High As Specified Deviation Pass Fail
As Specified Deviation Pass Fail and mark as Location 3A retained for next steps.
field for Temperature Limit screen appears
198. Touch the text for Text for Location 2 is
186. Enter “22” and then The Alarm Settings screen Location 2 highlighted As Specified Deviation Pass Fail
the Enter key appears and “22.0” is the
value in the High field for As Specified Deviation Pass Fail 199. Touch the Copy Audible confirmation tone is
icon heard As Specified Deviation Pass Fail
Temperature
Test Completed by: Date: 200. Touch the text for Text for Location 1 is
As Specified Deviation Pass Fail
Location 1 highlighted
List any observed deviations or comments.
Test Completed by: Date:
List any observed deviations or comments.

Reviewed By: Date:


Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 45 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 46 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail Test Action Specified Actual Pass/Fail
201. Select the Paste A message appears, “Are 214. Compare printouts Printed data is identical
icon you sure you want to copy As Specified Deviation Pass Fail marked Location 3A and except for Time field As Specified Deviation Pass Fail
settings…” Location 3B Note: Date may also be identical

202. Select Yes Screen closes and 215. Compare printouts Printed data is identical
Area/Location Setup screen As Specified Deviation Pass Fail marked Location 1B and except for Time, Location
is displayed As Specified Deviation Pass Fail
Location 2A ID, Location Name
Note: Date may also be identical
203. Touch the text for Text for Location 1 is
Location 1 highlighted As Specified Deviation Pass Fail
216. Select the Return The Counter Navigation
icon screen is displayed As Specified Deviation Pass Fail
204. Touch the Print Printout entitled Location
icon in the lower right of the Settings is generated for As Specified Deviation Pass Fail
screen Location 1 217. Remove zero count Sample inlet is uncapped
filter if in place on sample and unfiltered
205. Remove printout Printout is marked and inlet
As Specified Deviation Pass Fail
and mark as Location 1B retained for next steps.
Note: The resulting sample data
206. Touch the text for Text for Location 2 is from the next steps may show As Specified Deviation Pass Fail
As Specified Deviation Pass Fail Count Alarm markings and the
Location 2 highlighted
Sample screen may show
207. Select the PRINT Printout entitled Location indications of Count Alarm status.
This is acceptable for this test and
icon near the lower right Settings is generated for As Specified Deviation Pass Fail depends on the cleanliness of the
Location 2 air sampled.
208. Remove printout Printout is marked and 218. Select the Sample The Sample screen is
As Specified Deviation Pass Fail
and mark as Location 2B retained for next steps. icon displayed As Specified Deviation Pass Fail
209. Touch the text for Text for Location 3 is
Location 3 highlighted As Specified Deviation Pass Fail 219. If the location Area The label Area 1\Location 1
1\Location 1 is not the is displayed between the “-“
210. Select the PRINT Printout entitled Location current sample point, use button and the “+” button
icon near the lower right Settings is generated for As Specified Deviation Pass Fail As Specified Deviation Pass Fail
the “+” control to set Area
Location 3 1\Location 1 as the sample
point
211. Remove printout Printout is marked and
As Specified Deviation Pass Fail 220. Select the Run icon After DELAY time expires,
and mark as Location 3B retained for next steps.
sequence of three sample As Specified Deviation Pass Fail
212. Compare printouts Printed data is not identical cycles occurs.
marked Location 1A and As Specified Deviation Pass Fail
Test Completed by: Date:
Location 1B
List any observed deviations or comments.
213. Compare printouts Printed data is identical
marked Location 2A and except for Time field As Specified Deviation Pass Fail
Location 2B Note: Date may also be identical

Test Completed by: Date:


List any observed deviations or comments.

Reviewed By: Date:


Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 47 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 48 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail Test Action Specified Actual Pass/Fail
221. At completion of 3 Printout marked Run 1 is 232. Touch the box next Check box next to Print
cycles, a printout occurs, saved with this Protocol. to Print Averages so that a Averages contains a “check
As Specified Deviation Pass Fail
listing all three samples, “check mark” or “tick mark” mark” or “tick mark”
As Specified Deviation Pass Fail
starting with “Sample 3 of 3” appears within the box
printing out first. Mark as
233. Select the Return The Counter Navigation
Run 1 As Specified Deviation Pass Fail
icon screen is displayed
222. Select the Return The Counter Navigation
icon screen is displayed As Specified Deviation Pass Fail 234. Select the Sample The Sample screen is
As Specified Deviation Pass Fail
icon displayed

223. Select the Printer The Print Center screen is 235. Touch the blank The Select Location screen
icon displayed As Specified Deviation Pass Fail area between the “-“ button is displayed.
and the Area 1\Location 2
Note: It may be necessary to
As Specified Deviation Pass Fail
224. Change the Cycle The value 10-1 is displayed touch differing points within this
Print Order to 10-1 in the Cycle Print Order As Specified Deviation Pass Fail zone to trigger the screen change.
dropdown Using a stylus may help.

225. Select the Return The Counter Navigation 236. Touch the + sign An expanded list with 3
icon screen is displayed As Specified Deviation Pass Fail next to the Area 1 label to locations is shown As Specified Deviation Pass Fail
expand the list
226. Select the Sample The Sample screen is 237. Touch the label for The Location 3 label is
icon displayed As Specified Deviation Pass Fail Location 3 highlighted As Specified Deviation Pass Fail

227. Use the “+” control The label Area 1\Location 2


to set Area 1\Location 2 as is displayed between the “-“ As Specified Deviation Pass Fail 238. Select the OK The Select Location screen
the sample point button and the “+” button button disappears and the
SAMPLE screen is
As Specified Deviation Pass Fail
228. Select the Run icon After DELAY time expires, displayed with Area
sequence of three sample As Specified Deviation Pass Fail 1\Location 3 as the sample
cycles occurs. point label
229. At the end of each Printout containing all three 239. Select the Run icon After DELAY time expires,
cycle, a printout occurs, samples marked Run 2 is sequence of three sample As Specified Deviation Pass Fail
starting with “Sample 1 of 3” saved with this Protocol. As Specified Deviation Pass Fail cycles occurs.
printing out first. Mark as 240. At the end of each Printout with all three
Run 2. cycle, a printout occurs, samples and average data
230. Select the Return The Counter Navigation starting with “Sample 1 of 3” marked Run 3 is saved with
As Specified Deviation Pass Fail As Specified Deviation Pass Fail
icon screen is displayed and including an average of this Protocol.
the three runs. Mark as
231. Select the Printer The Print Center screen is Run 3.
As Specified Deviation Pass Fail
icon displayed
Test Completed by: Date:
Test Completed by: Date: List any observed deviations or comments.
List any observed deviations or comments.

Reviewed By: Date:


Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 49 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 50 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail
241. On the display, Screen changes to
4.2 System Security
touch the empty area enlarged display of only the
between the column for labels and data for Size As Specified Deviation Pass Fail Purpose:
Size and the column for and Cumulative count data
Cumulative.
This section verifies the MET ONE 3400 software security. The MET ONE security testing
includes verification of default user roles and IDs, user login process, controlled access
242. Touch the empty Screen returns to standard
area between the column Sample screen display
verification and user account management verification.
As Specified Deviation Pass Fail
for Size and the column for
Cumulative. Execution Materials, Documents, and Instruments:
243. In the right-hand Tab shows information on 1. User Manual MET ONE 3400 Series
side of the Sample screen, current flow rate, volume As Specified Deviation Pass Fail
touch the Environment tab. sampled, and Count Mode. 2. Zero Count Filter
244. In the right-hand Tab shows: 3. HACH-furnished USB flash drive
side of the Sample screen, Group: ____________ 4. User IDs and Passwords for all User Roles defined in section 4.2.1 User Roles and User
Group: Default
touch the Settings tab. Cycles: ____________
Cycles: 3 IDs.
Delay: ____________ Pass Fail
Delay: 00:00:10
Hold: ____________
Hold: 00:00:08 Test Setup:
Sample: ____________
Sample: 00:00:06
1. Verify that the power supply is properly set up and connected.
245. Select the Quick Message box appears, 2. Verify that all passwords are set to the default password: 123456
Settings text asking “Are you sure you As Specified Deviation Pass Fail
want to continue?” 3. Verify that at least one battery is installed. The green light for Battery status (below the
Power button) may blink if the battery or batteries are not at full charge. The Battery status
246. Select the No Message box disappears
button As Specified Deviation Pass Fail LED should be a steady green light when the installed battery or batteries are fully charged.
These tests can be conducted whether charging is in progress or completed.
247. Select the Return The Counter Navigation 4. Verify that the printer has a roll of paper installed with at least half a roll of unused paper
icon screen is displayed As Specified Deviation Pass Fail remaining.
Test Completed by: Date:
5. Install the zero-count filter on sample inlet.
List any observed deviations or comments.
6. Unit is powered on.

Test Method:
1. Record all User IDs required in section 4.2.1 User Roles and User IDs.
2. Execute the following test scripts:
x Section 4.2.2 Security Verification (Administrator Level Logged On)
x Section 4.2.3 Security Verification (No User Logged On)
x Section 4.2.4 Security Verification (Operator Level Logged On)
Reviewed By: Date:
Acceptance Criteria:
1. Actual is equivalent to Specified.

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 51 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 52 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
4.2.1 User Roles and User IDs 4.2.2 Security Verification (Administrator Level Logged On)
User Role Type Description User ID Default Password Test Action Specified Actual Pass/Fail

Basic This level is active only when the box for User N/A N/A 1. From the Counter System Settings screen
Logon Required is not checked. This is the Navigation screen, appears As Specified Deviation Pass Fail
normal active level when the instrument is select the System icon
first received. The operator has full rights and 2. Select the BASIC tab System Settings screen
this is equivalent to the Administrator level. is displayed with the As Specified Deviation Pass Fail
Operator This user level will have access to start/stop a user 123456 Basic tab on top
sample, Location Name and print reports 3. If no black checkmark A checkmark or “tick”
Administrator In addition to having all the rights of an admin 123456 or “tick” mark is mark is present in the
Operator, the administrator level has access displayed in the white white box to the left of
to make changes on all setup screens except box to the left of User User Logon Required As Specified Deviation Pass Fail
the Factory Setup screen, which is read-only. Logon Required, touch
the white field so that a
Factory This login is for factory service technician use N/A N/A check mark is present
only. The functionality of the Factory user is
beyond the scope of this Protocol. 4. Select the Return The Counter Navigation
As Specified Deviation Pass Fail
icon screen appears
5. Select the Lock icon The Lock icon changes
to a “closed” mode and
a message Admin logged
As Specified Deviation Pass Fail
off appears in red for a
brief time in the lower
left corner
6. Access now limited Only 4 icons now visible:
to 4 icons: Sample, Sample, Historical,
Historical, Printer, Printer, Diagnostics, As Specified Deviation Pass Fail
Diagnostics plus Lock and
Power/Battery icons
7. Select Sample Sample screen is
As Specified Deviation Pass Fail
displayed
8. Attempt to change No changes occur; an
the Location ID by error tone sounds
As Specified Deviation Pass Fail
pressing the + and –
icons
9. Select the Run icon No changes occur; an
As Specified Deviation Pass Fail
error tone sounds
Test Completed by: Date:
List any observed deviations or comments.

Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 53 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 54 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail Test Action Specified Actual Pass/Fail
10. Select the Power The Battery Diagnostics 22. Select the Return The Historical screen
As Specified Deviation Pass Fail
Cord/Battery icon screen appears icon (View Buffered Data) As Specified Deviation Pass Fail
appears
11. Select the Return The Battery Diagnostics
As Specified Deviation Pass Fail
icon screen closes 23. Select the Return The Counter Navigation
As Specified Deviation Pass Fail
icon screen appears
12. Select the The Counter Navigation
As Specified Deviation Pass Fail
Return icon screen appears 24. Select the Lock icon The User Logon screen
As Specified Deviation Pass Fail
appears
13. Select the Historical The View Buffered Data
As Specified Deviation Pass Fail
icon screen is displayed 25. Select the User The Counter Navigation
Name field, enter admin screen appears. An
14. Attempt to scroll The screen scrolls and select Enter. Admin logged on
through available sample through all data buffers message displays
As Specified Deviation Pass Fail Select the Password As Specified Deviation Pass Fail
buffers by pressing the + containing stored count briefly on the bottom of
field, enter 123456 and
and – icons data the screen.
select Enter. Select the
15. Select the Data The Data Filter Setup OK button
Filter icon (with green screen is displayed As Specified Deviation Pass Fail
26. Select the SAMPLE The Sample screen
arrow on bottom row) As Specified Deviation Pass Fail
icon appears
16. Select the check box A “check mark” or “tick
27. Attempt to change Location names change
next to Location 2 in mark” appears in the box As Specified Deviation Pass Fail the Location ID by as the “+” and “-“ buttons
Location Name list box As Specified Deviation Pass Fail
pressing the “+” and “-“ are pressed
buttons
17. Select the Return The View Buffered Data
icon screen is displayed, with 28. Select the Run icon Run icon changes to
As Specified Deviation Pass Fail
entry of Data Filter Active STOP icon; DELAY
As Specified Deviation Pass Fail
on header countdown occurs and
pump starts
18. Select the Print icon The Print Center screen
As Specified Deviation Pass Fail
is displayed 29. Select the Stop icon STOP icon reverts to
As Specified Deviation Pass Fail
Run icon; pump stops
19. Select the Buffer The message Printing
icon (Data Filter Active) 30. Select the Return The Sample screen
As Specified Deviation Pass Fail
appears briefly on the icon closes and the Counter
As Specified Deviation Pass Fail
screen Navigation screen is
displayed
20. Printout is generated Printout is marked “Run
for Location 2; mark it 2B” As Specified Deviation Pass Fail 31. Select the The View Buffered Data
As Specified Deviation Pass Fail
as Run 2B Historical icon screen is displayed
21. Compare values on Printouts of sample data 32. Select the Return The View Buffered Data
printout Run 2 and Run are identical As Specified Deviation Pass Fail icon screen closes and the
As Specified Deviation Pass Fail
2B Counter Navigation
screen is displayed
Test Completed by: Date:
Test Completed by: Date:
List any observed deviations or comments.
List any observed deviations or comments.

Reviewed By: Date:


Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 55 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 56 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail Test Action Specified Actual Pass/Fail
33. Select the Export The Export Sample Data 43. Select the Return The Group Setting
As Specified Deviation Pass Fail
icon screen appears icon Management screen
closes and the Counter As Specified Deviation Pass Fail
34. If attached, remove If not initially present, or Navigation screen is
the USB flash drive to once the USB drive is displayed
invoke a warning removed, the error
As Specified Deviation Pass Fail
message message “USB Flash 44. Select the System The System Settings
As Specified Deviation Pass Fail
Drive - Not Installed” icon screen appears
appears.
45. Select the Users tab The System Settings
35. Select Return icon The Export Sample Data screen is open with the As Specified Deviation Pass Fail
screen closes and the Users tab on top
As Specified Deviation Pass Fail
Counter Navigation
screen is displayed 46. Select the user The word user is
As Specified Deviation Pass Fail
entry highlighted
36. Select the Printer The Print Center screen
As Specified Deviation Pass Fail 47. Select Edit button The Manage User
icon appears
Account screen is
As Specified Deviation Pass Fail
37. Select the Return The Print Center screen displayed with user in the
icon closes and the Counter User Name field
As Specified Deviation Pass Fail
Navigation screen is
displayed 48. Select the Access The Access Rights tab is
As Specified Deviation Pass Fail
Rights tab displayed
38. Select the Test The Test and Report
As Specified Deviation Pass Fail 49. Select the following Access Rights tab is
Wizard icon Wizard screen appears
rights from the choices displayed with the
39. Select the Return The Test and Report listed by verifying that a following items selected:
icon Wizard screen closes “check mark” or “tick
Sampling is selected
and the Counter As Specified Deviation Pass Fail mark” is present in the
Navigation screen is box preceding these Report Wizard is
displayed titles: selected
As Specified Deviation Pass Fail
Sampling Historical is selected
40. Select the The Area/Location Set-up
As Specified Deviation Pass Fail Report Wizard
Locations icon screen appears
Historical Export is selected
41. Select the Return The Area/Location Set-up Export Printer is selected
icon screen closes and the
As Specified Deviation Pass Fail Printer Diagnostics is selected
Counter Navigation
screen is displayed Diagnostics

42. Select the Group The Group Setting 50. Select the OK button The Manage User
icon Management screen As Specified Deviation Pass Fail Accounts screen closes
As Specified Deviation Pass Fail
appears and the System Settings
screen is displayed
Test Completed by: Date:
Test Completed by: Date:
List any observed deviations or comments.
List any observed deviations or comments.

Reviewed By: Date:


Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 57 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 58 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail 4.2.3 Security Verification (No User Logged On)
51. Select the Return The System Settings Test Action Specified Actual Pass/Fail
icon screen closes and the
As Specified Deviation Pass Fail 1. Access now limited Only 4 icons now visible:
Counter Navigation
screen is displayed to 4 icons: Sample, Sample, Historical,
Historical, Printer, Printer, Diagnostics, As Specified Deviation Pass Fail
52. Select the Sizes The Size Setup screen Diagnostics plus Lock and
icon. appears Power/Battery icons
Note: This option is not As Specified Deviation 2. Select Sample Sample screen is
installed or visible on all units. Pass Fail As Specified Deviation Pass Fail
displayed
Mark as “n/a” if this selectable N/A
channel option is not installed 3. Attempt to change No changes occur; an
on your system. Skip to step #
the Location ID by error tone sounds
54. As Specified Deviation Pass Fail
pressing the + and –
icons
53. Select the Return The Size Setup screen
As Specified Deviation 4. Select the Run icon No changes occur; an
icon closes and the Counter As Specified Deviation Pass Fail
Pass Fail error tone sounds
Navigation screen is
N/A
displayed
5. Select the Power The Battery Diagnostics
As Specified Deviation Pass Fail
Cord/Battery icon screen appears
54. Select the Lock icon The message Admin
logged off appears 6. Select Return icon Sample screen returns As Specified Deviation Pass Fail
briefly at the bottom of 7. Select Return icon Counter Navigation
As Specified Deviation Pass Fail As Specified Deviation Pass Fail
the screen; the Lock icon screen returns
changes to a “closed” or
“locked position 8. Select the The System Diagnostics
As Specified Deviation Pass Fail
Diagnostics icon screen appears
Test Completed by: Date:
9. Select the Return The System Diagnostics
List any observed deviations or comments. icon screen closes and the
As Specified Deviation Pass Fail
Counter Navigation
screen is displayed
10. Unplug the power Battery icon(s) appears
supply and wait 10 at bottom of the screen As Specified Deviation Pass Fail
seconds
11. Select Battery icon The Battery Diagnostics
As Specified Deviation Pass Fail
screen appears
Reviewed By: Date: 12. Select Return icon The Counter Navigation
As Specified Deviation Pass Fail
screen returns
13. Plug in the power Power Cord icon appears
supply to the unit at bottom of the screen As Specified Deviation Pass Fail
and wait 10 seconds
Test Completed by: Date:
List any observed deviations or comments.

Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 59 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 60 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail 4.2.4 Security Verification (Operator Level Logged On)
14. Select the Lock icon User Logon screen Test Action Specified Actual Pass/Fail
As Specified Deviation Pass Fail
appears 1. Select the Lock icon User Logon screen
As Specified Deviation Pass Fail
appears
15. Select the User A message display 2. Select User Name The message Operator
Name field. appears with the field, enter user and logged on appears
message select Enter briefly at the bottom of
Enter user and select
“Invalid User Name or the screen
Enter. 3. Select the Password As Specified Deviation Pass Fail
Password” As Specified Deviation Pass Fail field, enter 123456 and
Touch Password field
select Enter. Select the
and enter 34567 and
OK button
select Enter.
4. Select the Sample The Sample screen is
Select the OK button. As Specified Deviation Pass Fail
icon displayed
16. Select OK Message display closes As Specified Deviation Pass Fail 5. Attempt to change The Location ID changes
Location ID by pressing by increment and As Specified Deviation Pass Fail
17. Select Cancel The Counter Navigation the + and – icons decrement
As Specified Deviation Pass Fail
screen is displayed 6. Touch the screen on Screen shifts to an
or near one of the enlarged view of only As Specified Deviation Pass Fail
Test Completed by: Date:
displayed Size labels the count data
List any observed deviations or comments.
7. Again, touch the The screen returns to
screen on or near one of the standard display with
As Specified Deviation Pass Fail
the displayed Size labels multiple information
panels
8. Select the Run icon The particle counter
As Specified Deviation Pass Fail
starts a count cycle
9. When the pump The particle counter
Reviewed By: Date: starts, select the Stop stops collecting As Specified Deviation Pass Fail
icon samples; pump stops
10. Select the Power The Battery Diagnostics
As Specified Deviation Pass Fail
Cord/Battery icon screen appears
11. Select the Return The Sample screen is
icon displayed As Specified Deviation Pass Fail

12. Select the Return The Counter Navigation


As Specified Deviation Pass Fail
icon screen is displayed
13. Select the Test The Test and Report
Wizard icon Wizard screen is As Specified Deviation Pass Fail
displayed
Test Completed by: Date:
List any observed deviations or comments.

Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 61 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 62 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail
14. Select the Return The Counter Navigation
4.3 Group Settings
As Specified Deviation Pass Fail
icon screen is displayed
Purpose:
15. Select the Export The Export Sample Data As Specified Deviation Pass Fail
icon screen is displayed This section verifies that the Group Settings feature of the MET ONE 3400 functions per
manufacturer’s specifications.
16. Select the Return The Counter Navigation As Specified Deviation Pass Fail
icon screen is displayed
Execution Materials, Documents, and Instruments:
17. Select the Printer The Print Center screen As Specified Deviation Pass Fail 1. User Manual MET ONE 3400 Series
icon appears.

18. Select the Return The Counter Navigation As Specified Deviation Pass Fail Test Setup:
icon screen is displayed
1. Verify that the power supply is properly set up and connected.
19. Select the The System Diagnostics As Specified Deviation Pass Fail 2. Verify that at least one battery is installed. The green light for Battery status (below the
Diagnostics icon screen appears Power button) may blink if the battery or batteries are not at full charge. The Battery status
20. Press the Print icon A SYSTEM STATUS LED should be a steady green light when the installed battery or batteries are fully charged.
in the lower right printout is created, These tests can be conducted whether charging is in progress or completed.
corner showing the system
status, including the
3. Verify that the printer has a roll of paper installed with at least half a roll of unused paper
serial number, date, time, As Specified Deviation Pass Fail remaining.
firmware version, OS 4. Unit is powered on. Power Cord icon displays if battery is fully charged.
version, CC version, and
the System Diagnostics
5. Log out all current users.
values. 6. Log in at the Administrator level.
21. Remove the printout Printout is attached to 7. Check the Counter Navigation>System>System Settings screen to confirm that no sound
and attach to this this procedure As Specified Deviation Pass Fail parameters are set to None and that the volume is set to an audible level. Return to the
procedure Counter Navigation screen.
22. Select the Return The Counter Navigation 8. Select the Group icon on the Counter Navigation menu.
As Specified Deviation Pass Fail
icon screen is displayed 9. Set up a new group name with the title Group 1 by selecting the <New> item in the list box.
23. Log off the MET The message Operator 10. Configure the parameters for Group 1 as defined in the tables below using the instructions
ONE 3400 by logged off appears found in the User Manual MET ONE 3400 Series. The procedure assumes that the Unit
As Specified Deviation Pass Fail
pressing the Lock briefly at the bottom of
Under Test [UUT] is set up with 8 size channels. If the UUT has fewer size channels, modify
icon the screen
the procedure by marking the unused channel entries as “not applicable” or “n/a”.
Test Completed by: Date:
List any observed deviations or comments.

General Tab Parameters


Parameter Setting
Count Cycles 1
Run Mode Auto
Reviewed By: Date: Count Display Cumulative
Count Mode Counts

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 63 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 64 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Timing Tab Parameters 15. Set up a new group name with the title Group 2 by selecting the <New> item in the list box.
Parameter Setting 16. Configure the parameters for Group 2 as defined in the following tables using the User
Sample Time 00:01:00 Manual MET ONE 3400 Series instructions.
Hold Time 00:01:00
Delay Time 00:01:00
General Tab Parameters
Parameter Setting
Count Cycles 2
Alarm Settings for Count Parameters
Run Mode Manual
Count Conc.
Parameter
Limit Limit Count Display Differential
Size Channel 1 1 8 Count Mode Counts/Cu ft.
Size Channel 2 2 7
Size Channel 3 3 6
Size Channel 4 4 5 Timing Tab Parameters
Size Channel 5 5 4 Parameter Setting
Size Channel 6 6 3 Sample Time 00:02:00
Size Channel 7 7 2 Hold Time 00:02:00
Size Channel 8 8 1 Delay Time 00:02:00

Note: Enter the High alarm value for each parameter first,
before setting the Low alarm, or an error message might be generated. Alarm Settings for Count Parameters
Alarm Settings for Environmental Tab Parameters Count Conc.
Parameter
Parameter Low High Enabled Limit Limit
Temperature 1.0 10.0 yes Size Channel 1 8 1
Relative Humidity 1.0 10.0 yes Size Channel 2 7 2
Air Velocity 1.0 10.0 yes Size Channel 3 6 3
Size Channel 4 5 4
Size Channel 5 4 5
Size Channel 6 3 6
Group Settings > Locations
Size Channel 7 2 7
Parameter Setting
Size Channel 8 1 8
Location Area 1\Location 1

11. Return to the Counter Navigation screen. Select the Printer icon; set the Sample Print
Mode to None
12. Return to Group Setting Management screen. Save these values as Group 1 by selecting
the Group icon, highlighting the Group 1 entry in the list box, and then selecting the Save
button.
13. Select the Print icon in the lower right corner to generate a printout of this configuration.
14. Label the printout as Group 1 A. Save with this procedure.
IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 65 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 66 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Note: Enter the High alarm value for each parameter first, 4.3.1 Group Settings
before setting the Low alarm, or an error message might be generated.
Test Action Specified Actual Pass/Fail
Alarm Settings for Environmental Tab Parameters
1. Load Group 1, verify Group 1 As Specified Deviation Pass Fail
Parameter Low High Enabled
Active Group:
Temperature 2.0 9.0 yes
Relative Humidity 2.0 9.0 yes 2. Select the Print icon Printout of Group Settings As Specified Deviation Pass Fail
is generated
Air Velocity 2.0 9.0 yes
3. Mark as Group 1 B Printout marked as As Specified Deviation Pass Fail
“Group 1 B”

4. Compare printout All entries match with the


Sample Location Parameters
marked Group 1 A with exclusion of the DATE As Specified Deviation Pass Fail
Parameter Setting printout marked Group and TIME values
Location Area 1\Location 2 1B

5. Save Printouts with Printouts attached As Specified Deviation Pass Fail


this procedure
17. Return to the Counter Navigation screen. Select the Printer icon; set the Sample Print 6. Select the Return The Counter Navigation As Specified Deviation Pass Fail
Mode to All icon screen appears
18. Select the Group icon. Save the parameters that have been entered above under the Group 7. Select the Sample The Sample screen As Specified Deviation Pass Fail
2 entry in the Group Setting Management screen. icon appears
19. Select the Print icon in the lower right corner to generate a printout of this configuration.
8. Select the Quick A message box appears to
20. Label the printout as Group 2 A and save with this procedure. Settings text on the confirm “Are you sure As Specified Deviation Pass Fail
Settings tab you want to continue?”
Test Method: 9. Select the YES The message box closes;
1. Load Group 1 settings and record all setup parameters as specified in section 4.3.1 Group button the Sample Setup (Group As Specified Deviation Pass Fail
Settings. Select the Group>Print icon to create printed copy of settings and label the 1 Group) screen appears
printouts manually as Group 1 B. Confirm the settings match those specified. 10. Verify the General
2. Load Group 2 settings and record all setup parameters as specified in section 4.3.1 Group tab parameters: Count Cycles 1
Count Cycles Count Cycles __________
Settings. Select the Group>Print icon to create printed copy of settings and label the Run Mode Auto
Run Mode Run Mode __________
printouts manually as Group 2 B. Confirm the settings match those specified. Count Dis. Cumulative Pass Fail
Count Display Count Display __________
Count Mode Counts
Count Mode Count Mode __________
Acceptance Criteria:
1. Actual is equivalent to Specified. Test Completed by: Date:
List any observed deviations or comments.

Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 67 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 68 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail Test Action Specified Actual Pass/Fail
11. Verify the Timing 19. Verify the
tab parameters: 00:01:00 Sample Time: __________ Environmental tab Low High Low High
Sample Time: 00:01:00 Hold Time: __________ Pass Fail parameters: ______ _______
Hold Time: 00:01:00
Measurement
1 10 Pass Fail
Delay Time: __________ Temperature: ______ _______
Delay Time: 1 10
Relative Humidity: ______ _______
12. Select the Return The Sample screen 1 10
As Specified Deviation Pass Fail Air Velocity:
icon appears
20. Select the Return The Group Settings screen
13. Select the Return The Counter Navigation As Specified Deviation Pass Fail
As Specified Deviation Pass Fail icon appears
icon screen appears
21. Select the Return The Group Setting
14. Select the Group The Group Setting icon Management screen As Specified Deviation Pass Fail
icon Management screen As Specified Deviation Pass Fail appears
appears
22. Select the Return The Counter Navigation
As Specified Deviation Pass Fail
15. Select the Settings The Group Settings screen icon screen appears
As Specified Deviation Pass Fail
button appears 23. Select the Printer The Print Center screen
As Specified Deviation Pass Fail
16. Verify the Sample icon appears
Location parameters: Area 1\Location 1 24. Verify Print Center Sample Print Mode is
As Specified Deviation Pass Fail
Sample for the Sample Print “None” As Specified Deviation Pass Fail
Location Mode parameter:
17. Select the Alarms The Alarm Settings screen 25. Select the Return The Counter Navigation
As Specified Deviation Pass Fail As Specified Deviation Pass Fail
icon appears icon screen appears
18. Verify the Count 26. Select the Group The Group Setting
tab parameters: Count Conc. Count Conc. icon Management screen As Specified Deviation Pass Fail
Size appears
Limit Limit Limit Limit
Size Channel 1 27. Load Group 2,
1 8 ______ _______ Group 2 As Specified Deviation Pass Fail
Size Channel 2 verify Active Group:
2 7 ______ _______
Size Channel 3 28. Select the Print Printout of System
3 6 As Specified Deviation Pass Fail
Size Channel 4 ______ _______ icon Settings is generated
Size Channel 5 4 5 Pass Fail
______ _______ 29. Mark as Group 2 B Printout marked as Group
Size Channel 6 5 4 As Specified Deviation Pass Fail
6 3 ______ _______ 2B
Size Channel 7
Size Channel 8 7 2 ______ _______ 30. Compare printout All entries match with the
marked Group 2 A exclusion of the DATE
8 1 ______ _______ As Specified Deviation Pass Fail
with printout and TIME values
N/A any channels that marked Group 2 B
are not used. ______ _______
31. Save Printouts with Printouts attached
As Specified Deviation Pass Fail
this procedure
Test Completed by: Date:
Test Completed by: Date:
List any observed deviations or comments.
List any observed deviations or comments:

Reviewed By: Date:


Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 69 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 70 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail Test Action Specified Actual Pass/Fail
32. Select the Return The Counter Navigation 44. Verify the Count Count Conc.
As Specified Deviation Pass Fail Count Conc
icon screen appears tab parameters:
Limit Limit Limit Limit
Size
33. Select the Sample The Sample screen
As Specified Deviation Pass Fail Size Channel 1 ______ _______
icon appears 8 1
Size Channel 2 ______ _______
34. Select the Quick A message box appears to 7 2
Settings text on the confirm “Are you sure As Specified Deviation Pass Fail Size Channel 3
6 3 ______ _______
Settings tab you want to continue?” Size Channel 4 Pass Fail
5 4 ______ _______
Size Channel 5
35. Select the YES The message box closes; 4 5
button the Sample Setup (Group As Specified Deviation Pass Fail Size Channel 6 ______ _______
3 6
2 Group) screen appears Size Channel 7 ______ _______
2 7
36. Verify the General Size Channel 8
1 8 ______ _______
tab parameters: Count Cycles __________ N/A any channels that
are not used. ______ _______
Count Cycles 2 Run Mode __________
Run Mode Manual Pass Fail 45. Verify the
Count Display __________ Environmental tab
Count Display Differential Low High Low High
Count Mode __________ parameters:
Count Mode Counts/Cu. Ft. 2 9
Measurement ______ _______ Pass Fail
Temperature: 2 9
37. Verify the Timing ______ _______
Relative Humidity: 2 9
tab parameters: Sample Time: __________ ______ _______
Air Velocity:
Sample Time: 00:02:00 Hold Time: __________ Pass Fail
Hold Time: 00:02:00 46. Select the Return The Group Settings screen
Delay Time: __________ As Specified Deviation Pass Fail
Delay Time: icon appears
00:02:00
47. Select the Return The Group Setting
38. Select the Return The Sample screen icon Management screen As Specified Deviation Pass Fail
As Specified Deviation Pass Fail appears
icon appears
39. Select the Return The Counter Navigation 48. Select the Return The Counter Navigation
As Specified Deviation Pass Fail As Specified Deviation Pass Fail
icon screen appears icon screen appears

40. Select the Group The Group Setting 49. Select the Printer The Print Center screen
As Specified Deviation Pass Fail
icon Management screen As Specified Deviation Pass Fail icon appears
appears 50. Verify Print Center Sample Print Mode is
41. Select the Settings The Group Settings screen for the Sample “All”
As Specified Deviation Pass Fail As Specified Deviation Pass Fail
button appears Print Mode
parameter:
42. Verify the Sample
Location parameters: 51. Select the Return The Counter Navigation
Area 1\Location 2 As Specified Deviation Pass Fail As Specified Deviation Pass Fail
icon screen appears
Sample Location
Test Completed by: Date:
43. Select the Alarms The Alarm Settings screen List any observed deviations or comments.
As Specified Deviation Pass Fail
icon appears
Test Completed by: Date:
List any observed deviations or comments.

Reviewed By: Date:

Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 71 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 72 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
4.4 Operating Modes 4.4.1 Auto Mode
Test Action Specified Actual Pass/Fail
Purpose: 1. Remove zero count Zero count filter is not
As Specified Deviation Pass Fail
This section verifies that the Auto, Manual and Beep run modes for the MET ONE 3400 function filter if installed attached to the unit
as specified in the Operator Manual. 2. Log on as an Admin The message Admin
Logged on is briefly As Specified Deviation Pass Fail
displayed
Execution Materials, Documents, and Instruments:
3. On the Counter The System Setting
1. User Manual MET ONE 3400 Series Navigation screen, screen is displayed As Specified Deviation Pass Fail
2. Zero Count Filter select the System icon
4. Select the Options The Options and
and Accessories tab Accessories tab is now As Specified Deviation Pass Fail
Test Setup: on top
1. Verify that the power supply is properly set up and connected. 5. Select the Clear The Clear Sample Buffer
2. Verify that at least one battery is installed. The green light for Battery status (below the Buffer button message box is As Specified Deviation Pass Fail
Power button) may blink if the battery or batteries are not at full charge. The Battery status displayed
LED should be a steady green light when the installed battery or batteries are fully charged. 6. Select the Yes The Options and
These tests can be conducted whether charging is in progress or completed. button Accessories tab is
displayed; statement As Specified Deviation Pass Fail
3. Verify that the printer has a roll of paper installed with at least half a roll of unused paper Data Buffer: 0 is
remaining. displayed
4. Unit is powered on. Power Cord icon displays if battery is fully charged. 7. Select the Return The Counter Navigation
As Specified Deviation Pass Fail
icon screen appears
5. Check the Counter Navigation>System>System Settings screen to confirm that the 3400 8. Select the Historical Message box appears:
icon As Specified Deviation Pass Fail
has been configured so that a user login is required, that no sound parameters are set to “NO DATA”
None, and that the volume is set to an audible level. Return to the Counter Navigation 9. Select the OK button Message box
As Specified Deviation Pass Fail
screen. disappears
6. Log out current user. 10. On the Counter The Group Setting
Navigation screen, Management screen is As Specified Deviation Pass Fail
select the Group icon displayed
11. Load the Default Active group equals
Test Method: As Specified Deviation Pass Fail
group Default
1. Execute the test scripts in section 4.4.1 Auto Mode. 12. Select the Return The Counter Navigation
As Specified Deviation Pass Fail
2. Print and save Average report for section 4.5 Test Wizard Verification. icon screen appears
3. Execute the test scripts in section 4.4.2 Manual Mode. 13. Select the Printer The Print Center screen
As Specified Deviation Pass Fail
icon is displayed.
4. Execute the test scripts in section 4.4.3 Beep Mode.
14. Set the Sample Print The Sample Print Mode
5. Print ISO 14644-1, FS 209E, BS5295 and Buffer reports and save for section 4.5 Test As Specified Deviation Pass Fail
Mode to All is set to “All”
Wizard Verification.
Test Completed by: Date:
List any observed deviations or comments.
Acceptance Criteria:
1. Actual is equivalent to Specified.

Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 73 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 74 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail Test Action Specified Actual Pass/Fail
15. Set the Print A “check mark” or “tick 25. Start an Auto sample Sample run begins and
Averages function mark” is present in the run by selecting the collects a set of 3
As Specified Deviation Pass Fail
box next to Print Run icon samples before stopping
Averages As Specified Deviation Pass Fail
Note: It is acceptable for
16. Select the Return The Counter Navigation Count Alarm to occur during
As Specified Deviation Pass Fail test; audible alarm may be
icon screen appears silenced if desired

17. Select the Sample The Sample screen As Specified Deviation Pass Fail
icon appears 26. Tear off printout and Printed Average report
mark as 4.4.1 Auto marked as “4.4.1 Auto
18. Touch Quick A message box appears Mode. Save printout Mode” and is saved as As Specified Deviation Pass Fail
Settings on the to confirm “Are you sure As Specified Deviation Pass Fail for section 4.5 Test source data for 4.5 Test
Settings tab you want to continue?” Wizard Verification. Wizard Verification
19. Select the YES The message box
Test Completed by: Date:
button closes; the Sample
As Specified Deviation Pass Fail List any observed deviations or comments.
Setup (Default Group)
screen appears
20. Program these
Count cycles
General tab parameters Count cycles 3
Count Cycles Run Mode Auto Run Mode
Pass Fail
Run Mode Count Display Cumulative Count Display
Count Display Count Mode Counts
Count Mode Count Mode Reviewed By: Date:
21. Program these
Sample Time
Timing tab parameters Sample Time 00:01:00
Sample Time Hold Time 00:00:00 Hold Time Pass Fail
Hold Time Delay Time 00:00:06 Delay Time
Delay Time

22. Select the Return The Sample screen is


As Specified Deviation Pass Fail
icon displayed

23. Remove any All printouts have been


printouts from the removed As Specified Deviation Pass Fail
front of the MET
ONE 3400

24. Verify the sample Sample point is set to


point is set to Area Area 1\Location 1 As Specified Deviation Pass Fail
1\Location 1, or use
the “+” button to set
Test Completed by: Date:
List any observed deviations or comments.

Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 75 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 76 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
4.4.2 Manual Mode 4.4.3 Beep Mode
Test Action Specified Actual Pass/Fail Test Action Specified Actual Pass/Fail
1. Install the Zero Zero Count Filter is 1. Install the Zero Count Zero Count Filter is
As Specified Deviation Pass Fail
Count Filter attached to counter inlet Filter if it is not already attached to counter inlet As Specified Deviation Pass Fail
2. Set the sampling The Location ID is set to installed
point to Area Area 1\Location 2 2. Set the sample point The sample point is set
1\Location 2 by As Specified Deviation Pass Fail to Area 1\Location 3 by to “Area 1\Location 3”
As Specified Deviation Pass Fail
using the “+” on the using the “+” on the
Sample screen Sample screen
3. Touch Quick A message box appears 3. Select the Return icon The Counter Navigation
As Specified Deviation Pass Fail
Settings on the to confirm “Are you sure As Specified Deviation Pass Fail screen is displayed
Settings tab you want to continue?” 4. Select the Group icon The Group Setting
4. Select the YES The message box Management screen is As Specified Deviation Pass Fail
button closes; the Sample displayed
As Specified Deviation Pass Fail
Setup (Default Group) 5. Verify Active Group: Text Active Group:
screen appears As Specified Deviation Pass Fail
Default Default is displayed
5. Program these Count Cycles 3 Count Cycles __________ 6. Select the Settings The Group Settings
General tab Run Mode Manual Run Mod __________ As Specified Deviation Pass Fail
Pass Fail button screen is displayed
parameters Count Display Cumulative Count Display __________
7. Select the Settings The Sample Setup
Count Mode Counts Count Mode __________ icon (Default) screen is As Specified Deviation Pass Fail
6. Select the Return The Sample screen is displayed
As Specified Deviation Pass Fail
icon displayed 8. Program these General 5 Count Cycles __________
7. Remove any All printouts have been tab parameters
printouts from the removed Count Cycles Beep Run Mode __________
As Specified Deviation Pass Fail
front of the MET Run Mode Count Display __________
Cumulative Pass Fail
ONE 3400
Count Display Counts Count Mode __________
8. Start a Manual Sample run begins and Count Mode
sample run by collects only 1 sample 1 Interval __________
As Specified Deviation Pass Fail Interval
selecting the Run before stopping and
icon. printing result 9. Select the Return icon The Group Settings
As Specified Deviation Pass Fail
9. Start another Sample run begins and screen is displayed
Manual sample run collects only 1 sample
As Specified Deviation Pass Fail
by selecting the Run before stopping and 10. Select the Alarms The Alarm Settings
As Specified Deviation Pass Fail
icon. printing result icon screen is displayed
10. Tear off printout and Printout marked as “4.4.2 11. Select the first entry of Label for Size 1 and
mark as 4.4.2 Manual Mode” and is the Size column alarm values are As Specified Deviation Pass Fail
Manual Mode. Save saved as source data highlighted
As Specified Deviation Pass Fail
printout for section for Report Verification
4.5 Test Wizard test 12. Select the Edit button Enter Count Limit screen
Verification. in the Count Limit is displayed As Specified Deviation Pass Fail
column
Test Completed by: Date:
Test Completed by: Date:
List any observed deviations or comments.
List any observed deviations or comments.

Reviewed By: Date: Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 77 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 78 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail Test Action Specified Actual Pass/Fail
13. Select “1” then Enter The Size Channel 1 25. Select the Sample The Sample screen is
As Specified Deviation Pass Fail
key Count Limit on the Alarm icon displayed
As Specified Deviation Pass Fail
Settings screen is set to 26. Start a Beep sample Sample run begins and
“1”. run by selecting the Run collects 5 samples
14. Select the Return icon The Group Settings icon. before stopping.
As Specified Deviation Pass Fail
screen is displayed. Listen for the unit to beep
during the run. As Specified Deviation Pass Fail
15. Select the Return icon The Group Setting
Management screen is As Specified Deviation Pass Fail Note: Jiggle the filter assembly at
top of counter to dislodge a few
displayed particles. Unit beeps when count
16. Select the Print icon A printout of Group is detected.
As Specified Deviation Pass Fail
Settings is generated 27. Tear off printout and Printout marked as “4.4.3
17. Verify printout shows Printout shows: mark as 4.4.3 Beep Beep Mode” and is
Cycles = __________ Mode. Save printout for saved as source data As Specified Deviation Pass Fail
Cycles = 005
Cycles = 005 section 4.5 Test Wizard for Report Verification
Run Mode = Beep Run Mode = __________ Pass Fail
Run Mode = Beep Verification. test
Count Limit = 1
Count Limit = 1 Count Limit = __________
(for 1st Size) 28. Once final run has The Counter Navigation
completed, select the screen is displayed As Specified Deviation Pass Fail
18. Mark printout 4.4.3 Printout is marked 4.4.3
Return icon
Beep Mode Settings Beep Mode Settings
As Specified Deviation Pass Fail 29. Select the System The System Settings
and save with this and saved As Specified Deviation Pass Fail
procedure icon screen is displayed
30. Access the Sounds Use Test button to verify
19. Select the Return icon The Counter Navigation
As Specified Deviation Pass Fail tab, and set the volume nominal 50% volume As Specified Deviation Pass Fail
screen is displayed
to 50%
20. Select the System The System Settings 31. Select the Return icon The Counter Navigation
As Specified Deviation Pass Fail As Specified Deviation Pass Fail
icon screen is displayed screen is displayed
21. Select the Sounds tab The System Settings 32. Select the Historical The View Buffered Data
screen is displayed with As Specified Deviation Pass Fail
As Specified Deviation Pass Fail icon screen is displayed
the Sounds tab to the
33. Verify the current data Display is showing the
front.
displayed is Record #1 of first of 10 records in
22. Set the volume to Sound level is set to 10 as indicated by the buffer, denoted as “1/10” As Specified Deviation Pass Fail
maximum. Use Test maximum values between the “-“
As Specified Deviation Pass Fail
button to verify maximum and the +” symbols
volume
34. Select the Printer icon The Print Center screen
23. Select the Return icon The Counter Navigation As Specified Deviation Pass Fail
As Specified Deviation Pass Fail is displayed
screen is displayed
35. De-select Print The selection box next to
24. Remove any printouts All printouts have been As Specified Deviation Pass Fail
Averages Print Averages is empty
from the front of the MET removed As Specified Deviation Pass Fail
Test Completed by: Date:
ONE 3400
List any observed deviations or comments.
Test Completed by: Date:
List any observed deviations or comments.

Reviewed By: Date:


Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 79 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 80 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail 4.4.4 Test Wizard Data: Averages
36. Select the Buffer icon Printing message Test Action Specified Actual Pass/Fail
appears briefly; printout
As Specified Deviation Pass Fail 1. Install the Zero Count Zero Count Filter is
of 10 samples is
generated Filter if it is not already attached to counter inlet As Specified Deviation Pass Fail
installed
37. Mark the printout as Printout is marked as 2. Select the Test Test and Report Wizard
4.4.3 Buffer Printout, “4.4.3 Buffer Printout” As Specified Deviation Pass Fail
As Specified Deviation Pass Fail Wizard icon screen appears
tear off and save with and saved with
procedure procedure 3. From the Standard Averages is selected
dropdown window, select As Specified Deviation Pass Fail
38. Compare entries of 1st All data matches Averages
three records on 4.4.3 including Date and Time 4. Touch the Grade An audible error tone
Buffer Printout with stamps As Specified Deviation Pass Fail
As Specified Deviation Pass Fail dropdown window sounds; no action occurs
three sample records on
printout marked 4.4.1 5. Touch the Occupancy An audible error tone
As Specified Deviation Pass Fail
Auto Mode dropdown window sounds; no action occurs
6. Touch the Sizes An audible error tone
39. Compare entries of 4th All data matches As Specified Deviation Pass Fail
dropdown window sounds; no action occurs
and 5th records on 4.4.3 including Date and Time
Buffer Printout with two stamps 7. Touch the Right A new entry screen is
As Specified Deviation Pass Fail Arrow button near the presented starting with
sample records on As Specified Deviation Pass Fail
printout marked 4.4.2 middle bottom of the Locations
Manual Mode screen
8. Touch the area The Enter Number of
40. Compare entries of All data matches within the white boxed Samples screen appears As Specified Deviation Pass Fail
remaining five records on including Date and Time region
4.4.3 Buffer Printout stamps As Specified Deviation Pass Fail 9. Enter the value 99 The “Samples per
with five sample records followed by the Location” screen is
on printout marked 4.4.3 As Specified Deviation Pass Fail
ENTER key displayed with the value
Beep Mode 99
41. Select the Return icon The View Buffered Data 10. Touch the Right A new entry screen is
As Specified Deviation Pass Fail Arrow button near presented starting
screen is displayed As Specified Deviation Pass Fail
the middle bottom of with Locations
42. Select the Return Icon The Counter Navigation the screen
As Specified Deviation Pass Fail
screen is displayed 11. Touch the Add Area The Select Area screen
button appears As Specified Deviation Pass Fail
Test Completed by: Date:
List any observed deviations or comments.
12. Touch the text Area 1 The text Area 1 is
highlighted As Specified Deviation Pass Fail

Test Completed by: Date:


List any observed deviations or comments.

Reviewed By: Date:

Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 81 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 82 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail Test Action Specified Actual Pass/Fail
13. Touch the OK button The Select Area screen 21. Touch the Print icon A printout of the summary
As Specified Deviation Pass Fail
disappears; the three data is generated.
locations belonging to Area As Specified Deviation Pass Fail 22. Tear off the printout Printout of the summary
1 are present in the and compare to the data and data on screen
Locations entry box As Specified Deviation Pass Fail
results shown on the are an exact match
14. Touch the Right A new entry screen allows screen.
Arrow button near the user to choose Begin 23. Mark printout as 4.4.4 Printout is marked as
As Specified Deviation Pass Fail
middle bottom of the Sampling [gather new data] Averages Wizard and “4.4.4 Averages Wizard”
screen or Use Existing Data As Specified Deviation Pass Fail
save printout with this and saved
15. Touch the selection A “check mark” or “tick procedure
box for Use Existing mark” appears in the box As Specified Deviation Pass Fail
Data 24. Touch the Export icon The Export Sample Data
As Specified Deviation Pass Fail
screen appears
16. Touch the Date From: The Date From: entry
As Specified Deviation Pass Fail
field screen appears 25. Select the Return icon The Export Sample Data
17. Touch the Enter key if A entry screen for Use screen disappears and the
As Specified Deviation Pass Fail
the default date is correct Existing Data is displayed report summary screen is
for the buffered data to again with date entry for re-displayed
be used, or enter the Date From: visible As Specified Deviation Pass Fail
correct starting date, 26. Touch the Return icon The Counter Navigation
followed by the Enter As Specified Deviation Pass Fail
screen is displayed
key
Test Completed by: Date:
18. Touch the Date To: The Date To: entry screen
As Specified Deviation Pass Fail List any observed deviations or comments.
field appears
19. Touch the Enter key if A entry screen for Use
the default date is correct Existing Data is displayed
for the buffered data to again with date entries for
be used, or enter the Date From: and Date To:
correct ending date, visible
followed by the Enter As Specified Deviation Pass Fail
key
Note: For data taken on the same
calendar date, it may be Reviewed By: Date:
necessary to input the “collection
date + 1” as the Date to: entry
20. Touch the Right A new summary screen
Arrow button near the appears showing the
middle bottom of the calculation results. Scroll
As Specified Deviation Pass Fail
screen bar on right edge allows
user to review
calculations.
Test Completed by: Date:
List any observed deviations or comments.

Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 83 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 84 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
4.4.5 Test Wizard Data: EU GMP Test Action Specified Actual Pass/Fail
Test Action Specified Actual Pass/Fail 13. Touch the Right A new entry screen is
Arrow button near presented starting with
1. Install the Zero Zero Count Filter is As Specified Deviation Pass Fail
the middle bottom of Locations
Count Filter if it is attached to counter inlet As Specified Deviation Pass Fail
the screen
not already installed
14. Touch the Add Area The Select Area screen
2. Select the Test Test and Report Wizard As Specified Deviation Pass Fail
As Specified Deviation Pass Fail button appears
Wizard icon screen appears
15. Touch the text Area The text Area 1 is
3. From the Standard As Specified Deviation Pass Fail
1 highlighted
dropdown window, EU GMP is selected As Specified Deviation Pass Fail
select EU GMP 16. Touch the OK button The Select Area screen
disappears; the three
4. From the Grade
locations belonging to Area As Specified Deviation Pass Fail
dropdown window, Grade D is selected As Specified Deviation Pass Fail
1 are present in the
select D
Locations entry box
5. From the
17. Touch the Right A summary screen shows
Occupancy
At Rest is selected As Specified Deviation Pass Fail Arrow button near the selected parameters:
dropdown window, Standard = __________
the middle bottom of
select At Rest Standard = EU GMP Grade = __________
the screen
6. From the Sizes Grade = D Room Status = __________ Pass Fail
dropdown window, “0.5” is selected As Specified Deviation Pass Fail Room Status = At Rest Sizes (um) = __________
select 0.5 Criteria = __________
Sizes (um) = 0.5; 5
7. Touch the Add “0.5” is placed in the and __________
As Specified Deviation Pass Fail Criteria = 3 520 000
button Considered Sizes box
and 29 000
8. From the Sizes
18. Touch the Right A new entry screen allows
dropdown window, “5” is selected As Specified Deviation Pass Fail
Arrow button near user to choose Begin
select 5 As Specified Deviation Pass Fail
the middle bottom of Sampling [gather new data]
9. Touch the Add “5” is placed in the the screen or Use Existing Data
As Specified Deviation Pass Fail
button Considered Sizes box 19. Touch the selection A “check mark” or “tick
box for Use mark” appears in the box As Specified Deviation Pass Fail
10. Touch the Right An audible tone sounds Existing Data
Arrow button near and new entry screen is
As Specified Deviation Pass Fail 20. Touch the Date The Date From: entry
the middle bottom of presented starting with As Specified Deviation Pass Fail
the screen Room Area From: field screen appears
11. Touch the empty The Enter Room Area 21. Touch the Enter key A entry screen for Use
Entry Box for Room screen appears As Specified Deviation Pass Fail if the default date is Existing Data is displayed
Area correct for the again with date entry for
buffered data to be Date From: visible
12. Touch the number 8 “8” is placed in the Room As Specified Deviation Pass Fail
used, or enter the
followed by the Area box As Specified Deviation Pass Fail correct starting date,
Enter button followed by the
Test Completed by: Date: Enter key
List any observed deviations or comments. Test Completed by: Date:
List any observed deviations or comments.

Reviewed By: Date:


Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 85 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 86 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail 4.4.6 Test Wizard Data: ISO 14644-1
22. Touch the Date To: The Date To: entry screen Test Action Specified Actual Pass/Fail
As Specified Deviation Pass Fail
field appears
1. Install the Zero Zero Count Filter is
23. Touch the Enter key A entry screen for Use Count Filter if it is not attached to counter inlet As Specified Deviation Pass Fail
if the default date is Existing Data is displayed already installed
correct for the again with date entries for
buffered data to be Date From: and Date To: 2. Select the Test Test and Report Wizard
As Specified Deviation Pass Fail
used, or enter the visible Wizard icon screen appears
correct ending date, 3. From the Standard
followed by the As Specified Deviation Pass Fail dropdown window, ISO 14644-1 is selected As Specified Deviation Pass Fail
Enter key select ISO 14644-1
Note: For data taken on the 4. From the Grade
same calendar date, it may be dropdown window, ISO Class 8 is selected As Specified Deviation Pass Fail
necessary to input the
“collection date + 1” as the select ISO Class 8
Date to: entry 5. From the
24. Touch the Right A new summary screen Occupancy dropdown At Rest is selected As Specified Deviation Pass Fail
Arrow button near appears showing the window, select At Rest
the middle bottom of calculation results. Scroll 6. From the Sizes
As Specified Deviation Pass Fail
the screen bar on right edge allows dropdown window, “0.5” is selected As Specified Deviation Pass Fail
user to review calculations select 0.5
and PASS/FAIL decision.
7. Touch the Add “0.5” is placed in the
25. Touch the Print icon A printout of the summary As Specified Deviation Pass Fail
As Specified Deviation Pass Fail button Considered Sizes box
data is generated.
8. Touch the Right An audible tone sounds
26. Tear off the printout Printout of the summary Arrow button near the and new entry screen is
and compare to the data and data on screen As Specified Deviation Pass Fail
As Specified Deviation Pass Fail middle bottom of the presented starting with
results shown on the are an exact match screen Room Area
screen.
9. Touch the empty The Enter Room Area
27. Mark printout as EU Printout is marked as “EU
Entry Box for Room screen appears As Specified Deviation Pass Fail
GMP Wizard and GMP Wizard” and saved
As Specified Deviation Pass Fail Area
save printout with
this procedure 10. Touch the number 8 “8” is placed in the
28. Touch the Export The Export Sample Data followed by the Enter Room Area box As Specified Deviation Pass Fail
As Specified Deviation Pass Fail button
icon screen appears
29. Select the Return The Export Sample Data 11. Touch the Right A new entry screen is
(bent arrow) icon screen disappears and the Arrow button near the presented starting with
As Specified Deviation Pass Fail As Specified Deviation Pass Fail
report summary screen is middle bottom of the Locations
re-displayed screen
30. Touch Return icon The Counter Navigation 12. Touch the Add Area The Select Area screen
As Specified Deviation Pass Fail As Specified Deviation Pass Fail
again screen is displayed button appears
Test Completed by: Date: Test Completed by: Date:
List any observed deviations or comments. List any observed deviations or comments.

Reviewed By: Date: Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 87 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 88 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail Test Action Specified Actual Pass/Fail
13. Touch the text Area The text Area 1 is 21. Touch the Enter key A entry screen for Use
As Specified Deviation Pass Fail
1 highlighted if the default date is Existing Data is displayed
14. Touch the OK button The Select Area screen correct for the buffered again with date entries
disappears; the three data to be used, or for Date From: and Date
locations belonging to As Specified Deviation Pass Fail enter the correct To: visible
Area 1 are present in the ending date, followed As Specified Deviation Pass Fail
Locations entry box by the Enter key
15. Touch the Right A summary screen shows Note: For data taken on the
Arrow button near the Standard = ____________ same calendar date, it may be
the selected parameters: necessary to input the
middle bottom of the Grade = ____________ “collection date + 1” as the
screen Standard = ISO 14644-1 Date to: entry
Grade = ISO Class 8 Room Status = ____________ Pass Fail
Sizes (um) = ____________ 22. Touch the Right A new summary screen
Room Status = At Rest
Arrow button near the appears showing the
Sizes (um) = 0.5 Criteria = ____________ middle bottom of the calculation results. Scroll
Criteria = 3 520 000 screen bar on right edge allows As Specified Deviation Pass Fail
user to review
16. Touch the Right A new entry screen
calculations and
Arrow button near the allows user to choose
PASS/FAIL decision.
middle bottom of the Begin Sampling [gather As Specified Deviation Pass Fail
screen new data] or Use Existing 23. Touch the Print icon A printout of the summary
Data As Specified Deviation Pass Fail
data is generated.
17. Touch the selection A “check mark” or “tick 24. Tear off the printout Printout of the summary
box for Use Existing mark” appears in the box As Specified Deviation Pass Fail
and compare to the data and data on screen As Specified Deviation Pass Fail
Data results shown on the are an exact match
18. Touch the Date The Date From: entry screen.
As Specified Deviation Pass Fail
From: field screen appears
25. Mark printout as ISO
Printout is marked and As Specified Deviation Pass Fail
19. Touch the Enter key A entry screen for Use 14644 and save with
is saved
if the default date is Existing Data is displayed this procedure
correct for the buffered again with date entry for 26. Touch the Return The Counter Navigation
data to be used, or Date From: visible As Specified Deviation Pass Fail As Specified Deviation Pass Fail
icon screen is displayed
enter the correct
starting date, followed Test Completed by: Date:
by the Enter key List any observed deviations or comments.
20. Touch the Date To: The Date To: entry As Specified Deviation Pass Fail
field screen appears
Test Completed by: Date:
List any observed deviations or comments.

Reviewed By: Date:

Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 89 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 90 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
4.5 Test Wizard Verification Acceptance Criteria:
1. Printed and manually calculated values are less than 1% different.
Purpose:
Note:
This section verifies that the MET ONE 3400 pre-configured reports accurately calculate and
1. Because the conversion values used for the manual calculation of the normalized count values may not be
report particle data collected during a typical run or from data stored in the buffer.
precisely identical to the values and precision used in the instrument’s firmware, small rounding or calculation
differences may be observed. To simplify the calculations and to save time, the manual calculations below
Execution Materials, Documents, and Instruments: use fixed conversion values whereas the instrument will normalize based on the recorded sample volume for
each sample. These differences should be less than 1%. A Pass should be given if the printed and manually
1. The printed particle count data and Average report from section 4.4.1 Auto Mode calculated values are less than 1% apart. If a closer match is desired, then the normalized sample data must
2. The printed particle count data from section 4.4.2 Manual Mode be calculated based on the sample volume recorded for each specific sample.
3. The printed particle count data from section 4.4.3 Beep Mode 2. A short discussion of the mathematics involved for these calculations is given in Appendix Q of this document
4. The printed particle count data from section 4.4.4 Test Wizard Data: Averages
5. The printed particle count data from section 4.4.5 Test Wizard Data: EU GMP
6. The printed particle count data from section 4.4.6 Test Wizard Data: ISO 14644-1
7. Annex C and Annex D of ISO 14644-1
8. EU GMP Annex 1

Note: The test is designed with the assumption that the instrument has 6 size channels. If the Unit
Under Test has a different number of channels, mark the unused channels as “not applicable” or
“n/a” for the case of fewer channels, and use only the initial 6 channels in the case of a unit with
more than 6 size channels.

Test Setup:
1. Execute Test Scripts from section 4.4 Operating Modes prior to execution of section 4.5.
2. Refer to the printed tapes collected during execution of section 4.4 for data to be entered in
this section.

Test Method:
1. Record the printed cumulative particle count data from section 4.4.1 Auto Mode as required
in section 4.5.1 Report Data Calculations.
2. Calculate the mean, mean of the averages, standard deviation and standard error of the
cumulative data as required in section 4.5.1 Report Data Calculations.
3. Compare the manually calculated results with the Print Averages values and verify that they
are equivalent.
4. Transfer recorded cumulative count values to the ISO 14644-1 Report Verification.
5. Calculate the averages of the recorded counts at each sample location and normalize values
to counts per cubic meter.
6. Calculate the mean of these normalized averages as well as the Standard Deviation,
Standard Error and 95% UCL (following methods as described in ISO 14644-1)
7. Compare the manually calculated results with the printed ISO 14644-1 report values and
verify that they are equivalent.

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 91 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 92 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
4.5.1 Print Averages Report Data Calculations 4.5.2 ISO 14644-1 Report Verification
Size Size Size Size Size Size
Size Size Size Size Size Size Test Action
Test Action Ch 1 Ch 2 Ch 3 Ch 4 Ch 5 Ch 6
Ch 1 Ch 2 Ch 3 Ch 4 Ch 5 Ch 6
1. Record the
1. Record the cumulative data from
cumulative data from section 4.4.3 [Location
section 4.4.1 for 3] for cycle 1 of 5
cycle 1 of 3
2. Record the
2. Record the
cumulative data from
cumulative data from
section 4.4.3 [Location
section 4.4.1 for
3] for cycle 2 of 5
cycle 2 of 3
3. Record the 3. Record the
cumulative data from cumulative data from
section 4.4.1 for section 4.4.3 [Location
cycle 3 of 3 3] for cycle 3 of 5
4. Calculate the 4. Record the
average for the 3 cumulative data from
cycles, rounding to section 4.4.3 [Location
one decimal place 3] for cycle 4 of 5
5. Record the 5. Record the
cumulative average cumulative data from
values shown on the section 4.4.3 [Location
Print Averages 3] for cycle 5 of 5
printout marked
4.4.1 Auto Mode 6. Calculate the
cumulative Average
for the 5 cycles of
6. Compare Location 3 (entry 1
calculated through 5 above)
cumulative average
from the printed 7. Record the
average and record cumulative data from
any difference. section 4.4.2 [Location
Rounded values 2] for first sample
should match. 8. Record the
Test Completed by: Date: cumulative data from
List any observed deviations or comments. section 4.4.2 [Location
2] for second sample
Test Completed by: Date:
List any observed deviations or comments.

Reviewed By: Date:

Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 93 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 94 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Size Size Size Size Size Size Size Size Size Size Size Size
Test Action Test Action
Ch 1 Ch 2 Ch 3 Ch 4 Ch 5 Ch 6 Ch 1 Ch 2 Ch 3 Ch 4 Ch 5 Ch 6
9. Calculate the 14. Calculate the
cumulative average mean of the
values for Location 2 cumulative averages
recorded at 4.5.2.7 in the preceding 3
and 4.5.2.8 rows
10. Write the 15. Calculate the
cumulative average Standard Deviation of
values for Location 1 the cumulative
recorded at 4.5.1.4 averages
above
16. Calculate the
11. To normalize the Standard Error
data to counts per
cubic meter, multiply 17. Using a Student’s
the results in step T value of 2.9 (for
4.5.2.6 [Location 3] by sample results based
35.3 (for 1 CFM on 3 locations),
models), 20 (for 50 calculate the 95%
LPM models) or 10 UCL
(for 100 LPM models) Test Completed by: Date:
12. To normalize the List any observed deviations or comments.
data to counts per
cubic meter, multiply
the results in step
4.5.2.9 [Location 2] by
35.3 (for 1 CFM
models), 20 (for 50
LPM models) or 10
(for 100 LPM models)
13. To normalize the
data to counts per Reviewed By: Date:
cubic meter, multiply
the results in step
4.5.2.10 [Location 1]
by 35.3 (for 1 CFM
models), 20 (for 50
LPM models) or 10
(for 100 LPM models)
Test Completed by: Date:
List any observed deviations or comments.

Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 95 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 96 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail
4.5.3 EU GMP Report Verification
18. Compare calculated Calculated and printed
normalized cumulative normalized cumulative Size Size Size Size Size Size
Test Action
average with printed average values match As Specified Deviation Pass Fail Ch 1 Ch 2 Ch 3 Ch 4 Ch 5 Ch 6
average for Location 3 for all sizes within 1% 1. Write the
[ISO 14644-1] normalized
cumulative average
19. Compare calculated Calculated and printed values for Location 3
normalized cumulative normalized cumulative recorded at 4.5.2.11
average with printed average values match As Specified Deviation Pass Fail above
average for Location 2 for all sizes within 1%
[ISO 14644-1] 2. Write the
normalized
cumulative average
20. Compare calculated Calculated and printed values for Location 2
normalized cumulative normalized cumulative recorded at 4.5.2.12
average with printed average values match As Specified Deviation Pass Fail above
average for Location 1 for all sizes within 1%
[ISO 14644-1] 3. Write the
normalized
Calculated and printed cumulative average
21. Compare calculated
Mean of the Averages values for Location 1
Mean of the Averages
As Specified Deviation Pass Fail recorded at 4.5.2.13
values with printed Mean values match for all
sizes within 1% above
of Averages [ISO 14644-1]
4. Write the mean of
22. Compare calculated Calculated and printed the normalized
Standard Deviation values Standard Deviation cumulative averages
As Specified Deviation Pass Fail recorded at 4.5.2.14
with printed Standard values match for all
Deviation [ISO 14644-1] sizes within 1% above
Test Completed by: Date:
23. Compare calculated Calculated and printed
List any observed deviations or comments.
Standard Error values with Standard Error values
As Specified Deviation Pass Fail
printed Standard Error match for all sizes
[ISO 14644-1] within 1%

24. Compare calculated Calculated and printed


UCL values with printed UCL values match for As Specified Deviation Pass Fail
UCL values [ISO 14644-1] all sizes within 1%

Test Completed by: Date: Reviewed By: Date:


List any observed deviations or comments.

Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 97 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 98 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail 4.6 Optional: USB Data Download Verification
5. Compare calculated Calculated and printed
normalized cumulative normalized cumulative Purpose:
average with printed average values match As Specified Deviation Pass Fail This section verifies that the data is correctly transferred when downloaded from the MET ONE
average for Location 3 [EU for all sizes within 1% 3400 onto the HACH-supplied USB flash drive and then onto a computer running Microsoft Excel
GMP]
or similar spreadsheet software capable of reading a .csv file.
6. Compare calculated Calculated and printed
normalized cumulative normalized cumulative Execution Materials, Documents, and Instruments:
average with printed average values match As Specified Deviation Pass Fail
1. The printed particle count data from section 4.4.1 Auto Mode
average for Location 2 [EU for all sizes within 1%
GMP] 2. USB flash drive as supplied with Model 3400
3. Computer with
7. Compare calculated Calculated and printed a. Operating System: Microsoft® Windows
normalized cumulative normalized cumulative
average with printed average values match As Specified Deviation Pass Fail b. USB 1.1 or 2.0 port
average for Location 1 [EU for all sizes within 1% c. Microsoft Excel or similar spreadsheet software capable of reading a .csv file
GMP]
4. Operator has proper permissions on computer to transfer data via USB and has permission to
8. Compare calculated Calculated and printed
access the spreadsheet program
Mean of the Averages Mean of the Averages
As Specified Deviation Pass Fail
values with printed Mean values match for all Test Setup:
of the Averages [EU GMP] sizes within 1%
1. Execute Test Scripts from section 4.4 Operating Modes prior to execution of section 4.6.
Test Completed by: Date: 2. Refer to the printed tape collected during execution of section 4.4.1 for data to be entered in
List any observed deviations or comments. this section.
3. Computer is on and Microsoft Excel is open
4. Operator is logged onto Model 3400 as ADMINISTRATOR
5. USB Flash Drive is available but not plugged in

Test Method:
1. Record the printed cumulative particle count data from section 4.4.1 Auto Mode
Reviewed By: Date: 2. Transfer 3400 buffer data to USB flash drive as a comma separated file.
3. Download .csv file to computer through USB port.
4. Compare the manually recorded results with the memory drive records for Location 001 and
verify that they are equivalent. These data values should be an exact match.

Acceptance Criteria:
1. Actual is equivalent to Specified or
2. If the certification is not performed then write “verification not performed” on each page of
Table 4.6.1 and sign.

Note:
If Unit-under-test has fewer than 6 channels, record the actual channels and mark the spaces for
entry of extra channels as “n/a”. If the unit-under-test has more than 6 channels, record only the
first 6 size channels for this test.

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 99 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 100 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
4.6.1 USB Data Download Verification 4.6.2 USB Data Verification

Test Action Expected Results Actual Results Pass / Fail Expected Results Actual – Location 1 Pass/
Test Action
(Data from 4.4.1 Cycle 1) (Computer Data: Cycle 1) Fail
1. Start at the Counter The Counter Navigation
As Specified Deviation Pass Fail
Navigation screen screen is displayed 1. Record the Size
Channel 1 particle count
2. Select the Export icon The Export Sample Data Pass Fail
values as indicated and
screen appears. The error verify they are equivalent
message, “USB Flash As Specified Deviation Pass Fail
Drive - Not Installed”
appears 2. Record the Size
Channel 2 particle count
3. Insert USB flash drive Error message Pass Fail
values as indicated and
into the 3400 disappears; USB Flash As Specified Deviation Pass Fail verify they are equivalent
Drive - Installed appears

4. In drop down for File Excel (.csv) is shown as 3. Record the Size
As Specified Deviation Pass Fail
Type, select Excel (.csv) File Type Channel 3 particle count
Pass Fail
values as indicated and
5. Select the EXPORT File Export screen verify they are equivalent
button appears; progress of
export shown as
As Specified Deviation Pass Fail
successive entries: 4. Record the Size
Building file; Uploading Channel 4 particle count
file; Validating file Pass Fail
values as indicated and
verify they are equivalent
6. File Export screen Counter Navigation is
disappears; Counter displayed As Specified Deviation Pass Fail
Navigation is displayed 5. Record the Size
Channel 5 particle count
7. Remove USB flash Memory drive is Pass Fail
values as indicated and
drive from Model 3400 recognized by computer verify they are equivalent
As Specified Deviation Pass Fail
and insert into USB port
on computer
6. Record the Size
8. Transfer data to Channel 6 particle count
spreadsheet aoftware Data appears in Pass Fail
As Specified Deviation Pass Fail values as indicated and
using comma-delimited spreadsheet display. verify they are equivalent
selection

Test Completed by: Date: Test Completed by: Date:


List any observed deviations or comments. List any observed deviations or comments.

Reviewed By: Date:


Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 101 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 102 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Expected Results Actual – Location 1 Pass/ Expected Results Actual – Location 1 Pass/
Test Action Test Action
(Data from 4.4.1 Cycle 2) (Computer Data: Cycle 2) Fail (Data from 4.4.1 Cycle 3) (Computer Data: Cycle 3) Fail

7. Record the Size 13. Record the Size


Channel 1 particle count Channel 1 particle count
Pass Fail Pass Fail
values as indicated and values as indicated and
verify they are equivalent verify they are equivalent

8. Record the Size 14. Record the Size


Channel 2 particle count Channel 2 particle count
Pass Fail Pass Fail
values as indicated and values as indicated and
verify they are equivalent verify they are equivalent

9. Record the Size 15. Record the Size


Channel 3 particle count Channel 3 particle count
Pass Fail Pass Fail
values as indicated and values as indicated and
verify they are equivalent verify they are equivalent

10. Record the Size 16. Record the Size


Channel 4 particle count Channel 4 particle count
Pass Fail Pass Fail
values as indicated and values as indicated and
verify they are equivalent verify they are equivalent

11. Record the Size 17. Record the Size


Channel 5 particle count Channel 5 particle count
Pass Fail Pass Fail
values as indicated and values as indicated and
verify they are equivalent verify they are equivalent

12. Record the Size 18. Record the Size


Channel 6 particle count Channel 6 particle count
Pass Fail Pass Fail
values as indicated and values as indicated and
verify they are equivalent verify they are equivalent

Test Completed by: Date: Test Completed by: Date:


List any observed deviations or comments. List any observed deviations or comments.

Reviewed By: Date: Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 103 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 104 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
4.7.1 Alarm Testing
4.7 Alarm Testing Test Action Specified Actual Pass/Fail
1. Remove zero count Zero count filter is not
As Specified Deviation Pass Fail
Purpose: filter if installed attached to the unit
This section verifies that the MET ONE 3400 generates and reports alarms as specified in the 2. Select the Printer The Print Center screen is
As Specified Deviation Pass Fail
operator manual. icon displayed
3. Set the Sample The Sample Print Mode is
As Specified Deviation Pass Fail
Print Mode to All set to “All”
Execution Materials, Documents, and Instruments:
4. Set Cycle Print The Cycle Print Order is
1. User Manual MET ONE 3400 Series. As Specified Deviation Pass Fail
order to 10-1 set to “10-1”
5. If needed, touch the The Print Averages box
Test Setup: select box next to Print contains a “check mark” or As Specified Deviation Pass Fail
1. Verify that the power supply is properly set up and connected. Averages to set “tick mark”
2. Verify that at least one battery is installed. The green light for Battery status (below the 6. Select the Return The Counter Navigation
As Specified Deviation Pass Fail
Power button) may blink if the battery or batteries are not at full charge. The Battery icon screen is displayed
status LED should be a steady green light when the installed battery or batteries are fully 7. Select the Group The Group Setting
charged. These tests can be conducted whether charging is in progress or completed. icon Management screen is As Specified Deviation Pass Fail
displayed
3. Verify that the printer has a roll of paper installed with at least half a roll of unused paper
8. Access the screen Active group equals
remaining. and load the Default Default group As Specified Deviation Pass Fail
4. Unit is powered on. Power Cord icon displays if battery is fully charged. group
5. Log out the current user. 9. Select the Settings The Group Settings screen
As Specified Deviation Pass Fail
6. Log in at the Administrator level. button is displayed
7. Check the Counter Navigation>System>System Settings screen to confirm that the 10. Select the Settings The Sample Setup
icon (Default) screen is As Specified Deviation Pass Fail
3400 has been configured so that a user login is required, that no sound parameters are displayed
set to None, and that the volume is set to an audible level.
11. Set Count Cycles to The value for Count Cycles
8. Check the Counter Navigation>System>Custom screen to confirm that the 3400 has As Specified Deviation Pass Fail
2 is set to “2”
been configured so that Store Partial Data is not enabled (no check mark in selection
12. Set Run Mode to The Run Mode is set to
box). Return to the Counter Navigation screen. As Specified Deviation Pass Fail
Auto “Auto”
13. Select the Timing
Test Method: tab and set the Sample Time is set to
As Specified Deviation Pass Fail
1. Execute the following test scripts in section 4.7.1 Alarm Testing. Sample Time to “00:01:00”
00:01:00
14. Set Hold Time to Hold Time is set to
Acceptance Criteria: As Specified Deviation Pass Fail
00:00:00 “00:00:00”
1. Actual is equivalent to Specified. 15. Set Delay Time to Delay Time is set to
As Specified Deviation Pass Fail
00:00:10 “00:00:10”
Test Completed by: Date:
List any observed deviations or comments.

Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 105 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 106 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail Test Action Specified Actual Pass/Fail
16. Select the Return The Group Settings screen 29. Select the Return The Counter Navigation
As Specified Deviation Pass Fail As Specified Deviation Pass Fail
icon is displayed icon screen is displayed
17. Select the Alarms The Alarm Settings screen 30. Remove any All printouts have been
As Specified Deviation Pass Fail
icon is displayed printouts from the front removed As Specified Deviation Pass Fail
18. Set the Size The Size Channel 1 Count of the MET ONE 3400
Channel 1 Count Limit Limit on the Alarm Settings As Specified Deviation Pass Fail 31. Select the Sample The Sample screen is
on the screen to 20,000 screen is set to “20,000” As Specified Deviation Pass Fail
icon displayed
19. Set the Size The Size Channel 2 Count 32. Start sample run by Sample run begins and
Channel 2 Count Limit Limit on the Alarm Settings As Specified Deviation Pass Fail selecting the Run icon collects 2 sets of samples As Specified Deviation Pass Fail
on the screen to 10,000 screen is set to “10,000” before stopping
20. Select the Return The Group Settings screen
As Specified Deviation Pass Fail 33. Ensure that particle Data Display area of the
icon is displayed
counts exceed the Main screen turns red and
21. Select the Return The Group Setting previously set alarm the size channel(s) that has
As Specified Deviation Pass Fail
icon Management screen is As Specified Deviation Pass Fail settings exceeded the alarm limit
displayed displays the count reading
22. Select the Return The Counter Navigation in yellow
As Specified Deviation Pass Fail
icon screen is displayed 34. Verify that the The Count Alarm message
23. Select the System The System Settings Count Alarm message blinks in a red color when
As Specified Deviation Pass Fail appears in red during the activated As Specified Deviation Pass Fail
icon screen is displayed
run when an alarm
24. On the Options The message screen Clear
occurs
and Accessories Sample Buffer is displayed As Specified Deviation Pass Fail
tab, select the Clear 35. Verify that touching The Count Alarm message
Buffer button the flashing Count continues to blink in a red
25. Select Yes Clear Sample Buffer Alarm message during color but there is no As Specified Deviation Pass Fail
screen disappears; the run silences the audible alarm
As Specified Deviation Pass Fail
Data Buffer value is 0. audible alarm
36. Verify that the Printout shows COUNT
26. Select the Units and Flow Rate Alarm set to printout shows a COUNT ALARM at the top of each
Alarms tab and set the “Enabled” ALARM heading for sample record and
As Specified Deviation Pass Fail
Flow Rate Alarm to sample cycle(s) that channel(s) in alarm are
Enabled exceeded the alarm indicated by a “>” mark in As Specified Deviation Pass Fail
27. Touch the Low% Flow Rate Alarm Low % is threshold; size(s) in the left margin of the
value field for Flow set to “5” alarm are indicated by a printout
As Specified Deviation Pass Fail “>” mark in the left
Rate Alarm; set value
to 5 margin of the printout
28. Touch the High% Flow Rate Alarm High% is 37. Remove printout and Printout marked as
value field for Flow set to “5” mark as COUNT “COUNT ALARM TEST” As Specified Deviation Pass Fail
As Specified Deviation Pass Fail ALARM TEST and save. and saved
Rate Alarm; set value
to 5 Test Completed by: Date:
Test Completed by: Date: List any observed deviations or comments.
List any observed deviations or comments.

Reviewed By: Date:


Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 107 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 108 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail Test Action Specified Actual Pass/Fail
38. Install a zero count Zero count filter is 46. Silence the audible Audible alarm stops;
filter on the inlet port to installed. As Specified Deviation Pass Fail alarm by touching the message Alarm Silenced
the counter flashing Flow Alarm! appears at top of screen; As Specified Deviation Pass Fail
39. Select the Environment tab is text Flow Alarm! continues to
Environment tab displayed with Flow and As Specified Deviation Pass Fail flash
Volume entries visible 47. When second count During second count cycle,
40. Start sample run by Sample run begins: pump cycle begins, Flow no Flow Alarm! Message is
As Specified Deviation Pass Fail
selecting the Run icon starts operating after Delay As Specified Deviation Pass Fail Alarm! Message clears displayed
time reaches 6 seconds
41. Wait until Run Flow value displayed 48. Allow both count Printout of first cycle has
begins, then completely decreases; pump stops; cycles to complete. Flow Alarm indication at
block the inlet with a display field for Examine printout for top of printout; none for
As Specified Deviation Pass Fail As Specified Deviation Pass Fail
finger or by crimping Environment changes both cycles second count cycle.
tubing (if connected) for color to red
at least 5 seconds
42. Flow Error is Flow Error message is 49. Remove printout and Printout marked as “FLOW
As Specified Deviation Pass Fail
displayed on the top line. displayed on the top line mark as FLOW ALARM ALARM TEST” and saved As Specified Deviation Pass Fail
43. Start sample run by Sample run begins: pump TEST and save.
selecting the Run icon starts operating after Delay As Specified Deviation Pass Fail
Test Completed by: Date:
time reaches “6” seconds
List any observed deviations or comments.
44. After Run begins, Flow value displayed
restrict the sample inlet decreases; display field for
with a finger or by Environment changes
crimping tubing but do color to red
not shut off flow entirely
Note: Intention is to restrict
flow to less than 95% of As Specified Deviation Pass Fail
nominal but not enough to
trigger automatic shut-off of
pump. This step may require
more than one attempt to Reviewed By: Date:
achieve an appropriate level of
restriction. If necessary, restart
sample run.

45. Remove the flow Flow value displayed


restriction returns to nominal;
display field for As Specified Deviation Pass Fail
Environment stays red;
count cycle continues

Test Completed by: Date:


List any observed deviations or comments.

Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 109 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 110 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
4.8.1 Response to Power Loss
4.8 Power Failure and Recovery Testing Test Action Specified Actual Pass/Fail
1. Remove zero count Zero count filter is not
Purpose: As Specified Deviation Pass Fail
filter if installed attached to the unit
This section verifies that the behavior of the MET ONE 3400 when power is lost. Because the unit 2. Verify battery is The battery is installed
was designed to operate from either an AC to DC power adapter and/or a battery, power loss will installed in the unit and and the battery indicator is As Specified Deviation Pass Fail
be tested both with and without the battery. fully charged green
3. Verify that the AC to The Power Cord icon
Execution Materials, Documents, and Instruments: DC power adapter is appears near the bottom of
As Specified Deviation Pass Fail
supplying power to the the Counter Navigation
None.
unit screen
4. Select the Printer The Print Center screen is
Test Setup: As Specified Deviation Pass Fail
icon displayed
Note:
5. Set the Sample Print The Sample Print Mode is
When there is a possibility to enable or disable a function on the particle counter, the As Specified Deviation Pass Fail
Mode to All set to “All”
presence of a checkmark 9 within the adjacent box ; indicates that the function is
6. Set Cycle Print The Cycle Print Order is
ENABLED; an empty box … indicates the function is DISABLED. order to 10-1 set to “10-1”
As Specified Deviation Pass Fail

7. If needed, touch the The Print Averages box


1. Verify that the power supply is properly set up and connected. select box next to Print does not contain a “check As Specified Deviation Pass Fail
2. Verify that at least one battery is installed and fully charged. The green light for Battery Averages to set off mark” or “tick mark”
status (below the Power button) may blink if the battery or batteries are not at full charge. 8. Select the Return The Counter Navigation
As Specified Deviation Pass Fail
The Battery status LED should be a steady green light when the installed battery or batteries icon screen is displayed
are fully charged. 9. Touch the System The System Settings
3. Verify that the printer has a roll of paper installed with at least half a roll of unused paper icon screen is shown with the
As Specified Deviation Pass Fail
Options and Accessories
remaining. tab on top
4. Unit is powered on. 10. Touch the Options The System Settings
5. If a logon is required, log in at the Administrator level. and Accessories tab screen is shown with the
As Specified Deviation Pass Fail
6. Check the Counter Navigation>System>System Settings screen, Basic tab to confirm Options and Accessories
tab on top
that the 3400 has been configured so that a) User Logon Required is enabled, b) that no
sound parameters are set to None and c) that the volume is set to an audible level. 11. Select the Clear A warning message entitled
Buffer button “Clear Sample Buffer” As Specified Deviation Pass Fail
7. Return to the Counter Navigation screen. appears
8. Near the bottom of the screen, the Power Cord icon is displayed if battery is fully charged. 12. Select the Yes Text states that Data
As Specified Deviation Pass Fail
9. Select the Printer icon to go to the Print Center screen; enable Repeat Sample Headers. button Buffer: “0”
10. Return to the Counter Navigation screen. 13. Select the Return The Counter Navigation
As Specified Deviation Pass Fail
icon screen is displayed

Test Completed by: Date:


Test Method: List any observed deviations or comments.
1. Execute the following test scripts in section 4.8.1 Response to Power Loss.

Acceptance Criteria:
1. Actual is equivalent to Specified.
Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 111 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 112 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail Test Action Specified Actual Pass/Fail
14. Touch the The Area/Location Setup 29. Set Hold Time to Hold Time is set to
As Specified Deviation Pass Fail As Specified Deviation Pass Fail
Locations icon screen is shown 00:00:08 “00:00:08”
30. Set Delay Time to Delay Time is set to
As Specified Deviation Pass Fail
15. Touch the Add The Sample Location Setup As Specified Deviation Pass Fail 00:00:10 “00:00:10”
Location button screen is shown
31. Select the Return The Group Settings screen
As Specified Deviation Pass Fail
16. Touch the selection The Enter Location Name icon is displayed
As Specified Deviation Pass Fail
box for Location Name screen is shown 32. Select the Return The Group Setting
icon Management screen is As Specified Deviation Pass Fail
17. Type in Location 5, The Add Sample Location
As Specified Deviation Pass Fail displayed
followed by the Enter screen is shown with
key Location 5 visible 33. Select the Return The Counter Navigation
As Specified Deviation Pass Fail
icon screen is displayed
18. Touch the selection The Enter Location ID As Specified Deviation Pass Fail
box for Location ID screen is shown 34. Select the Sample The Sample screen is
As Specified Deviation Pass Fail
icon displayed
19. Type in 5, followed The Add Sample Location
by the Enter key screen is shown with As Specified Deviation Pass Fail 35. Set the sample The sample point is set to
Location ID = 5 visible point to Area “Area 1\Location 5”
1\Location 5 by using As Specified Deviation Pass Fail
20. Select the Return The Area/Location screen
As Specified Deviation Pass Fail the “+” on the Sample
icon is displayed
screen
21. Select the Return The Counter Navigation
As Specified Deviation Pass Fail 36. Remove any All printouts have been
icon screen is displayed
printouts from the front removed As Specified Deviation Pass Fail
22. Select the Group The Group Setting of the MET ONE 3400
icon Management screen is As Specified Deviation Pass Fail
displayed 37. Start an Auto Sample run begins and
sample run by collects 5 sets of samples As Specified Deviation Pass Fail
23. Load the Default Active group equals
As Specified Deviation Pass Fail selecting the Run icon before stopping
group Default group
24. Select the The Group Settings screen 38. Remove the Printed particle count data
As Specified Deviation Pass Fail printout; mark as is marked as “POWER As Specified Deviation Pass Fail
Settings button is displayed
POWER LOSS A LOSS A” and saved
25. Select the The Sample Setup screen
Settings icon is displayed with the As Specified Deviation Pass Fail 39. Select the Return The Counter Navigation
As Specified Deviation Pass Fail
General tab on top icon screen is displayed
26. Set the Count The value for Count Cycles 40. Select the Printer The Print Center screen is
As Specified Deviation Pass Fail As Specified Deviation Pass Fail
Cycles to 5 is set to “5” icon displayed
27. Set the Run Mode The Run Mode is set to 41. Print the Buffer Printout generated and
As Specified Deviation Pass Fail
to Auto “Auto” report; mark as marked as “POWER LOSS As Specified Deviation Pass Fail
28. Select the Timing Sample Time is set to POWER LOSS B B”
tab and set the “00:00:06” Test Completed by: Date:
As Specified Deviation Pass Fail
Sample Time to
00:0:06 List any observed deviations or comments.

Test Completed by: Date:


List any observed deviations or comments.

Reviewed By: Date:


Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 113 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 114 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail Test Action Specified Actual Pass/Fail
42. Compare data of Data printed shall match 53. Clear the The box adjacent to
POWER LOSS B and POWER LOSS A As Specified Deviation Pass Fail checkmark in the box Repeat Sample Headers
POWER LOSS A As Specified Deviation Pass Fail
next to Repeat is empty
Sample Headers
43. Select the Return The Counter Navigation
As Specified Deviation Pass Fail
icon screen is displayed
54. Select the Buffer Printout occurs. Both
44. Unplug the AC to The Power Cord icon on icon to print the buffer header text and numerical
DC power adapter the Main screen changes As Specified Deviation Pass Fail count data of first sample
to a Battery icon printed matches printout
marked POWER LOSS B;
As Specified Deviation Pass Fail
45. Select the Printer The Print Center screen is remaining 4 sample records
As Specified Deviation Pass Fail
icon displayed have foreshortened header
text; numerical count data
46. Reprint the Buffer Data printed matches the matches printout marked
report; mark as Buffer report from step 41; As Specified Deviation Pass Fail POWER LOSS B
POWER LOSS C marked and saved
47. Remove the 55. Mark as POWER Printout marked and
As Specified Deviation Pass Fail
battery (or batteries) The unit shuts off As Specified Deviation Pass Fail LOSS E saved
from the unit
48. Reconnect the AC The Mode of Operation 56. Re-install the The battery indicator LED
to DC power adapter; screen appears battery on the front of the unit As Specified Deviation Pass Fail
wait about 30 seconds As Specified Deviation Pass Fail changes to green
for the counter to
Test Completed by: Date:
initialize
List any observed deviations or comments.
49. Log into the 3400 The Power Cord icon
with: User Name = appears on the Counter
admin Navigation screen and the As Specified Deviation Pass Fail
Password = 123456 battery status LED on the
front of the unit is not lit

50. Select the Printer The Print Center screen is


As Specified Deviation Pass Fail
icon displayed
Reviewed By: Date:
51. Reprint the Buffer Data printed matches the
Report; mark as Buffer Report from step 41; As Specified Deviation Pass Fail
POWER LOSS D marked and saved

52. Select the Printer The Print Center screen is


As Specified Deviation Pass Fail
icon displayed

Test Completed by: Date:


List any observed deviations or comments.

Reviewed By Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 115 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 116 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
5.1 Option: User Selectable Size Channels
5 Tests for Certain Options Purpose:
The 3400 Particle Counter being qualified under this Protocol may be equipped with optional This section verifies the functionality of the option for the user selection of size channel values if
accessories such as a RH/Temperature sensor and/or an Air Velocity sensor as well as the unit is supplied with user selectable size channel option.
enhanced functionality such as Selectable Size Channels or Ethernet Wireless Connectivity.
Execution Materials, Documents, and Instruments:
In the cases where these options are not installed, or in cases where functions will not be used, 1. User Manual MET ONE 3400 Series
the following procedures should not be executed and should be marked as “not applicable” or
“n/a” Test Setup:
1. Verify that the power supply is properly set up and connected.
In the instances were one or more of these features or functions are added after the initial 2. Unit is powered on. Power Cord icon displays if battery is fully charged.
qualification, a limited IQ/OQ can be conducted using the appropriate procedure in this section. 3. Verify that at least one battery is installed. The green light for Battery status (below the
Power button) may blink if the battery or batteries are not at full charge. The Battery status
LED should be a steady green light when the installed battery or batteries are fully charged.
Note: These tests can be conducted whether charging is in progress or completed.
4. Log in at the Administrator level.
5. Go to the Counter Navigation screen
6. Select the Factory Icon
7. Under the Calibration tab, verify that the box adjacent to the words Configurable Channels
contains a “check” or “tick” mark. If not, then this feature is not installed. Do not continue this
procedure until this optional feature is installed and the box adjacent to the words
Configurable Channels contains a “check” or “tick” mark. It will usually be necessary to
provide an expanded calibration data set with 12 or more calibration points.
8. Check the Counter Navigation>System>System Settings screens to confirm that the 3400
has been configured so a) that the language for display is English, b) that no sound
parameters are set to None, and c) that the volume is set to an audible level.
9. Return to the Counter Navigation screen

CAUTION: Changing size channel information will delete all previously recorded sample records. If important count
records are still present in the counter’s memory, print or export the data before continuing procedure.

Test Method:
1. Execute the test scripts in section 5.1.1 User Selectable Channels and record all the Actual
results.

Acceptance Criteria:
1. Actual is equivalent to Specified or write n/a and sign on each page of Table 5.1.1.

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 117 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 118 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
5.1.1 Option: User Selectable Channels Test Action Specified Actual Pass/Fail
Test Action Specified Actual Pass/Fail 13. Enter a value different The Enter Channel Size
than the remaining size screen closes; the Size
1. Record the code word Code word recorded Code word
and within the range Setup screen is displayed
used to activate this ____________________ Pass Fail As Specified Deviation Pass Fail
posted at the top of the with the newly entered
function
screen; select Enter channel value displayed
2. On the Counter Group Setting in the list box
Navigation screen, select Management screen is As Specified Deviation Pass Fail
14. Select the Add Size The Enter Channel Size
the Group icon. displayed As Specified Deviation Pass Fail
icon screen appears
3. Touch the Print icon to Group SETTINGS
15. Enter a value the The Enter Channel Size
create a Group printout is generated As Specified Deviation Pass Fail
same as the only size screen closes; a message
SETTINGS printout.
listed; select Enter screen is displayed As Specified Deviation Pass Fail
4. Attach printout to this Printout attached to this stating that the channel
section, making note of section As Specified Deviation Pass Fail entered already exists
the existing size channels
16. Select the OK button The message box closes
5. Select the Return icon Counter Navigation to close the message box As Specified Deviation Pass Fail
As Specified Deviation Pass Fail
screen is displayed
6. Select the Sizes icon Size Setup screen is 17. Select the Add Size The Enter Channel Size
As Specified Deviation Pass Fail icon screen appears As Specified Deviation Pass Fail
displayed
7. Select one of the The selected size is 18. Enter a value different The Enter Channel Size
displayed sizes in the list highlighted in blue As Specified Deviation Pass Fail than the remaining size screen closes; the Size
box and within the range Setup screen is displayed
8. Select the Delete Size An audible tone is posted at the top of the with the newly entered As Specified Deviation Pass Fail
icon generated; the selected screen; select Enter channel value displayed
As Specified Deviation Pass Fail in the list box
size is removed from the
list.
9. Repeat the previous Only one size remains in 19. Enter 6 more values, Each value is added to
step until only one size the list box As Specified Deviation Pass Fail one at a time, within the the list box; eight values
remains visible range stated at the top of are displayed after the
the screen entries are all completed As Specified Deviation Pass Fail
10. Select the remaining The selected size is Note: The allowable range is set
As Specified Deviation Pass Fail
size highlighted in blue by the smallest and largest sizes
entered for the calibration curve.
11. Select the Delete An audible tone is
Size icon generated; the selected 20. Select the Add Size A message screen is
As Specified Deviation Pass Fail icon displayed: Already 8 As Specified Deviation Pass Fail
size remains highlighted
on the list. channels in list
12. Select the Edit Size The Enter Channel Size 21. Select the OK button The message box closes
As Specified Deviation Pass Fail As Specified Deviation Pass Fail
icon screen appears to close the message box
Test Completed by: Date: Test Completed by: Date:
List any observed deviations or comments. List any observed deviations or comments.

Reviewed By: Date:


Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 119 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 120 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail
22. Select the Return The Counter Navigation 5.2 Option: RH/T Sensor
icon screen is displayed As Specified Deviation Pass Fail
Purpose:
23. Select the Sizes icon Size Setup screen is
As Specified Deviation Pass Fail This section verifies the functionality of the option for RH/Temperature measurement
displayed
24. Enter the original Channel sizes returned Execution Materials, Documents, and Instruments:
channel size values as to original values As Specified Deviation Pass Fail
recorded in step 5.1.1.4 1. User Manual MET ONE 3400 Series
25. Verify that the list Visible list matches 2. Compatible RH/Temperature sensor [not initially connected]
contains the original set of printed list of size labels Note: The user can now connect one of two types of RH/Temperature probes to this version of the 3400. If the
sizes by comparing to the As Specified Deviation Pass Fail RH/Temperature probe is marked as “HMP50”, then confirm that the selection box marked HMP50 is checked
printout generated at the on the SYSTEM>UNITS AND ALARMS tab. Incorrect RH and Temperature values will be displayed when the
start of this procedure probe is connected if the incorrect type is set on this screen. If the checkbox for the HMP50 probe is not
26. Select the Return Counter Navigation marked, then the calibration curve used is for the standard RH/T probe.
As Specified Deviation Pass Fail
icon screen is displayed
Test Setup:
Test Completed by: Date:
1. Verify that the power supply is properly set up and connected.
List any observed deviations or comments.
2. Unit is powered on. Power Cord icon displays if battery is fully charged.
3. Install a zero-count filter on the sample inlet.
4. Log in at the Administrator level.
5. Check the Counter Navigation>System>System Settings screen to confirm that the 3400
has been configured so a) that the language for display is English, b) that no sound
Reviewed By: Date: parameters are set to None, and c) that the volume is set to an audible level.
6. Return to the Counter Navigation screen
7. Select the Sample icon

Test Method:
1. Execute the test scripts in section 5.2.1 RH/T Sensor and record all the Actual results.

Acceptance Criteria:
1. Actual is equivalent to Specified.

Note: For RH values in particular, the sensor data is rapidly changed by changes in the ambient conditions. The
displayed values and the printout values may not always match precisely because the readings are updated
each second and the printout values are those that occur exactly at the completion of the count cycle.
However, the values should be reasonably close.

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 121 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 122 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
5.2.1 Option: RH/T Sensor Test Action Specified Actual Pass/Fail
Test Action Specified Actual Pass/Fail 15. Select Settings icon Sample Setup (Default)
is displayed with General As Specified Deviation Pass Fail
1. On Sample display, Only values for Flow and
tab
with RH/T sensor not Volume are displayed
connected, verify that only 16. Program Count Count Cycles is set to 1
As Specified Deviation Pass Fail As Specified Deviation Pass Fail
Flow and Volume entries Cycles to 1
exist on right-side 17. Select Timing tab Sample Setup is
Environment panel As Specified Deviation Pass Fail
displayed with Timing tab
2. Connect the RH/T Values for Flow, Volume, 18. Program Sample Sample Time is set to
sensor; wait for 10 Temp and RH are As Specified Deviation Pass Fail As Specified Deviation Pass Fail
Time to 00:00:05 00:00:05
seconds displayed
19. Program Delay Time Delay Time is set to
3. Select the Return icon Counter Navigation As Specified Deviation Pass Fail
As Specified Deviation Pass Fail to 00:00:06 00:00:06
screen is displayed
20. Select the Return Group Settings screen is
4. Select Printer icon Print Center is displayed As Specified Deviation Pass Fail As Specified Deviation Pass Fail
icon displayed
5. Set Sample Print Sample Print Mode is set 21. Select the Alarms Alarm Settings screen is
As Specified Deviation Pass Fail As Specified Deviation Pass Fail
Mode to Alarms to Alarms icon displayed
6. Select the Return icon Counter Navigation 22. Select Alarm Settings is
As Specified Deviation Pass Fail
screen is displayed Environmental tab displayed with As Specified Deviation Pass Fail
7. Select System icon System Settings is Environmental tab
As Specified Deviation Pass Fail
displayed 23. Set Temperature to Temperature set to
As Specified Deviation Pass Fail
8. Select Units and System Settings is Enabled Enabled
Alarms tab displayed with Units and As Specified Deviation Pass Fail 24. Set Relative Relative Humidity set to
Alarms tab As Specified Deviation Pass Fail
Humidity to Enabled Enabled
9. Set Temperature Temperature units are 25. Set Low value for High value for
As Specified Deviation Pass Fail As Specified Deviation Pass Fail
units to Deg C set to Deg C Temperature to 0 Temperature set to 0
10. Verify if RH/T probe is White box next the HMP 26. Set High value for High value for
marked HMP RH/T. If RH/T text has a “check As Specified Deviation Pass Fail
Temperature to 10 Temperature set to 10
yes, then touch empty mark” or “tick mark” As Specified Deviation Pass Fail
box next to HMP RH/T 27. Set Low value for High value for Relative
As Specified Deviation Pass Fail
text Relative Humidity to 0 Humidity set to 0
11. Select the Return Counter Navigation 28. Set High value for High value for Relative
As Specified Deviation Pass Fail As Specified Deviation Pass Fail
icon screen is displayed Relative Humidity to 10 Humidity set to 10
12. Select Group icon Group Setting 29. Select the Return Group Settings screen is
As Specified Deviation Pass Fail As Specified Deviation Pass Fail
Management is displayed icon displayed
13. Load Default group Active Group is Default As Specified Deviation Pass Fail 30. Select the Print icon Group Settings printout
As Specified Deviation Pass Fail
is generated
14. Select Settings Group Settings is
As Specified Deviation Pass Fail Test Completed by: Date:
button displayed
Test Completed by: Date: List any observed deviations or comments.
List any observed deviations or comments.

Reviewed By: Date:


Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 123 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 124 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail Test Action Specified Actual Pass/Fail
31. Verify alarm and Period = 00:00:05 Period = ____________ 43. Select the Alarms Alarm Settings screen is
As Specified Deviation Pass Fail
count cycle settings icon displayed
Delay = 00:00:06 Delay = ____________
Count cycles = 1 Count cycles = ____________ 44. Select Alarm Settings is
Environmental tab displayed with As Specified Deviation Pass Fail
Temp High = 10 Temp High = ____________ Pass Fail
Environmental tab
Temp Low = off Temp Low = ____________
45. Set High value for High value for
RH High = 10 RH High = ____________ As Specified Deviation Pass Fail
Temperature to 100 Temperature set to 100
RH Low = off RH Low = ____________
46. Set High value for High value for Relative
As Specified Deviation Pass Fail
32. Select the Return Group Setting Relative Humidity to 100 Humidity set to 100
icon Management screen is As Specified Deviation Pass Fail 47. Select the Return Group Settings screen is
displayed As Specified Deviation Pass Fail
icon displayed
33. Select the Return Counter Navigation 48. Select the Print icon Group Settings printout
As Specified Deviation Pass Fail As Specified Deviation Pass Fail
icon screen is displayed is generated
34. Select the Sample Sample screen is 49. Verify alarm and
As Specified Deviation Pass Fail Period = 00:00:05 Period = ____________
icon displayed count cycle settings
Delay = 00:00:06 Delay = ____________
35. Initiate a count cycle Count cycle starts and
As Specified Deviation Pass Fail Count cycles = 1 Count cycles = ____________
by selecting the Run icon completes
Temp High = 100 Temp High = ____________ Pass Fail
36. Temperature alarm is Environmental panel
indicated on screen by turns red during count As Specified Deviation Pass Fail Temp Low = off Temp Low = ____________
color change cycle RH High = 100 RH High = ____________
37. Temperature alarm is Temp. Alarm flashes RH Low = off RH Low = ____________
indicated on screen by under Environmental As Specified Deviation Pass Fail 50. Select the Return Group Setting
color change panel during count cycle icon Management screen is As Specified Deviation Pass Fail
38. Temperature alarm is Heading on printout is displayed
indicated on printout “Temperature Alarm” 51. Select the Return Counter Navigation
As Specified Deviation Pass Fail
As Specified Deviation Pass Fail icon screen is displayed
Note: RH or “Relative Humidity
Alarm” may also be indicated if 52. Select the Sample Sample screen is
As Specified Deviation Pass Fail
the local RH value exceeds 10. icon displayed
39. RH and Temperature Values for RH and 53. Initiate a count cycle Count cycle starts and
As Specified Deviation Pass Fail As Specified Deviation Pass Fail
data recorded on printout Temperature data printed by selecting the Run icon completes
40. Select the Return Counter Navigation 54. No screen alarms are Environmental panel
As Specified Deviation Pass Fail
icon screen is displayed indicated stays yellow during count As Specified Deviation Pass Fail
41. Select the Group Group Setting cycle
icon Management screen is As Specified Deviation Pass Fail Test Completed by: Date:
displayed
List any observed deviations or comments.
42. Select the Settings Group Settings screen is
As Specified Deviation Pass Fail
button displayed
Test Completed by: Date:
List any observed deviations or comments.

Reviewed By: Date:

Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 125 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 126 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail
55. No printout occurs No printout generated at 5.3 Option: Network Connection
end of count cycle
Note: Unless an alarm occurs Purpose:
for counts or environmentals, As Specified Deviation Pass Fail
the printer setting of Alarms This section verifies the functionality of the optional use of network connections.
inhibits printer output for normal
readings.
Execution Materials, Documents, and Instruments:
56. Select the Return Counter Navigation
icon screen is displayed
As Specified Deviation Pass Fail 1. User Manual MET ONE 3400 Series
57. Select Printer icon Print Center is displayed As Specified Deviation Pass Fail 2. Correct cables for type of network connection

58. Set Sample Print Sample Print Mode is set 3. Permissions (as required in your company) for access to network connections
As Specified Deviation Pass Fail
Mode to All to All
Test Setup:
59. Select the Return Counter Navigation
As Specified Deviation Pass Fail 1. Verify that the power supply is properly set up and connected.
icon screen is displayed
60. Select the Sample Sample screen is 2. Unit is powered on. Power Cord icon displays if battery is fully charged.
As Specified Deviation Pass Fail
icon displayed 3. Install a zero-count filter on the sample inlet.
61. Initiate a count cycle Count cycle starts and
As Specified Deviation Pass Fail
4. Log in at the Administrator level.
by selecting the Run icon completes 5. Check the Counter Navigation>System>System Settings screen to confirm that the 3400
62. No screen alarms are Environmental panel has been configured so a) that the language for display is English, b) that no sound
indicated stays yellow during count As Specified Deviation Pass Fail parameters are set to None, and c) that the volume is set to an audible level.
cycle
6. Return to the Counter Navigation screen
63. Printout occurs Printout generated at end
of count cycle with RH As Specified Deviation Pass Fail 7. Select the Network icon
and Temperature values
64. Detach printer tape Printout attached to
and save with this procedure As Specified Deviation Pass Fail Test Method:
procedure 1. Execute the test scripts in section 5.3 Network Connection and record all the Actual results.
65. Remove the RH/T Only values for Flow and 2. If a specific communications Protocol will not be employed at this facility, mark the unused
sensor; wait for 10 Volume are displayed on As Specified Deviation Pass Fail
section or sections “n/a” or “not applicable” and sign and date the remark.
seconds Environment tab
Test Completed by: Date:
Acceptance Criteria:
List any observed deviations or comments.
1. Actual is equivalent to Specified.

Note: Not all potential network connections are tested in this set of procedures as the range of potential variations is
too great. This procedure is intended to verify more simply the availability of the settings and user access to
making the needed changes to implement the required network connection(s).

Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 127 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 128 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
5.3.1 Option: Wired Ethernet Connection Test Action Specified Actual Pass/Fail
9. Attempt to enter an Entry screen entitled Enter
Note: The user’s IT/IS Department or Network Administrator will need to verify or establish connections onto a Subnet mask by touching Subnet Mask is displayed
As Specified Deviation Pass Fail
community network. In the case of Ethernet connections, that person will need to know the MAC address of the the white field next to the
instrument. text Subnet Mask
This address should be visible on the Ethernet screen under Counter Navigation>Network>Ethernet 10. Select Cancel Entry screen closes and
Communication Settings As Specified Deviation Pass Fail
screens are visible
Test Action Specified Actual Pass/Fail
11. Attempt to enter an Entry screen entitled Enter
1. Select Ethernet tab Ethernet tab is on top of
Gateway address by Gateway Address is
Communication Settings As Specified Deviation Pass Fail As Specified Deviation Pass Fail
touching the white field displayed
screen
next to the text Gateway
2. Select DHCP function DHCP activated as
12. Select Cancel Entry screen closes and
by touching the white box denoted by the presence of
As Specified Deviation Pass Fail Communication Settings As Specified Deviation Pass Fail
adjacent to the text a “check mark” or “tick
screens are visible
mark” in the box
13. Touch circle next to Smaller black circle is
3. Attempt to enter an IP Error tone sounds; no
text FX located within larger “radio As Specified Deviation Pass Fail
address by touching the action occurs
As Specified Deviation Pass Fail button” to indicate selection
white field next to the text
IP Address 14. Attempt to enter a Entry screen entitled Enter
Config. Port address Configuration Port is As Specified Deviation Pass Fail
4. Attempt to enter an Error tone sounds; no
displayed
Subnet mask by touching action occurs
As Specified Deviation Pass Fail
the white field next to the 15. Select Cancel Entry screen closes and
text Subnet Mask Communication Settings As Specified Deviation Pass Fail
5. Attempt to enter an Error tone sounds; no screens are visible
Gateway address by action occurs 16. Touch circle next to Smaller black circle is
As Specified Deviation Pass Fail
touching the white field text Modbus located within larger “radio As Specified Deviation Pass Fail
next to the text Gateway button” to indicate selection
6. De-select DHCP DHCP de-activated as 17. Attempt to enter a Entry screen entitled Enter
As Specified Deviation Pass Fail
function by touching the denoted empty white Modbus Port address Modbus Port is displayed
As Specified Deviation Pass Fail
white box adjacent to the selection box next to DHCP 18. Select Cancel Entry screen closes and
text text Communication Settings As Specified Deviation Pass Fail
7. Attempt to enter an IP Entry screen entitled Enter screens are visible
address by touching the IP address is displayed Test Completed by: Date:
As Specified Deviation Pass Fail
white field next to the text
IP Address List any observed deviations or comments.
8. Select Cancel Entry screen closes and
Communication Settings As Specified Deviation Pass Fail
screens are visible
Test Completed by: Date:
List any observed deviations or comments.
Reviewed By: Date:

Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 129 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 130 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
5.3.2 Option: Wired Serial [RS-485] Connection 5.3.3 Option: Wireless Ethernet Connection
Test Action Specified Actual Pass/Fail Note: This option may not exist on all instruments. If this function is not activated, or is not used at this
location, marked through Section 5.3.3 and note as “n/a”
1. Select Serial tab Serial tab is on top of
Communication As Specified Deviation Pass Fail
Settings screen Test Action Specified Actual Pass/Fail
2. Touch circle next to text Smaller black circle is 1. Select WiFi WiFi Configuration tab is
FX located within larger Configuration tab on top of
As Specified Deviation Pass Fail As Specified Deviation Pass Fail
“radio button” to indicate Communication
selection Settings screen
3. Attempt to enter a FX ID Entry screen entitled 2. Attempt to enter a Entry screen entitled
As Specified Deviation Pass Fail Network Name (SSID) Enter Network Name As Specified Deviation Pass Fail
address Enter FX ID is displayed
address (SSID) is displayed
4. Select Cancel Entry screen closes and
Communication Settings As Specified Deviation Pass Fail 3. Select Cancel Entry screen closes and
screens are visible Communication Settings As Specified Deviation Pass Fail
screens are visible
5. Attempt to enter a Error tone sounds; no
As Specified Deviation Pass Fail 4. Touch circle next to text Smaller black circle is
Modbus ID address action occurs
Infrastructure located within larger
6. Touch circle next to text Smaller black circle is As Specified Deviation Pass Fail
“radio button” to indicate
Modbus RTU located within larger selection
As Specified Deviation Pass Fail
“radio button” to indicate
selection 5. Attempt to enter a Error tone sounds; no
As Specified Deviation Pass Fail
Channel address action occurs
7. Attempt to enter a FX ID Error tone sounds; no
As Specified Deviation Pass Fail 6. Touch circle next to text Smaller black circle is
address action occurs
Ad Hoc located within larger
8. Attempt to enter a Entry screen entitled As Specified Deviation Pass Fail
“radio button” to indicate
Modbus ID address Enter Modbus ID is As Specified Deviation Pass Fail selection
displayed
7. Attempt to enter a Select 9; dropdown
9. Select Cancel Entry screen closes and Channel address window collapses and 9 is
Communication Settings As Specified Deviation Pass Fail displayed
screens are visible Dropdown window As Specified Deviation Pass Fail
becomes available with
10. Touch Baud rate Select 19200; dropdown possible selection from 1
dropdown window collapses and 19200 is As Specified Deviation Pass Fail to 11
displayed
8. Attempt to enter a Data Error tone sounds; no
11. Select Manifold A check mark appears or Rate value. action occurs As Specified Deviation Pass Fail
Support by touching the disappears after each As Specified Deviation Pass Fail
adjacent box twice touch
9. Attempt to select Auto Error tone sounds; no
12. Select Auto Increment A check mark appears or Fallback by touching the action occurs
Port by touching the disappears after each As Specified Deviation Pass Fail adjacent box As Specified Deviation Pass Fail
adjacent box twice touch
Test Completed by: Date:
Test Completed by: Date:
List any observed deviations or comments.
List any observed deviations or comments.

Reviewed By: Date:


Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 131 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 132 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail Test Action Specified Actual Pass/Fail
10. Select Enable Radio Status checkmark 16. When Security is Encryption can be
by touching the adjacent changes from initial state equal to WPA, changed from TKIP to
As Specified Deviation Pass Fail
box twice to alternate state, then Authentication cannot TKIP/WEP, and back to
returns to initial state. be changed but all other TKIP; Key Type can be
As Specified Deviation Pass Fail
11. Attempt to enter a Select US; dropdown fields can be modified either HEX or
Country value. window collapses and US Passphrase; the Key
is displayed and Retype Key fields
Dropdown window
As Specified Deviation Pass Fail are open for user entry
becomes available with 6
possible selections of 17. When Security is Encryption can be
abbreviated country equal to WPA2/802.11i, chosen from list of CCMP,
names Authentication cannot CCMP/TKIP,
be changed but all other CCMP/WEP, TKIP,
12. Select WiFi Security WiFi Security tab is on
fields can be modified TKIP/WEP; Key Type As Specified Deviation Pass Fail
tab top of Communication As Specified Deviation Pass Fail
can be either HEX or
Settings screen
Passphrase; the Key
13. Attempt to enter a Select Disabled; and Retype Key fields
Security value. dropdown window are open for user entry
Dropdown window collapses and Disabled is
As Specified Deviation Pass Fail Test Completed by: Date:
becomes available with 4 displayed
possible selections of List any observed deviations or comments.
security Protocols
14. When Security is Authentication can be
equal to Disabled, the changed from Open to
only option is to change Shared, and back to As Specified Deviation Pass Fail
Authentication Open; no other choices
are available in this mode
15. When Security is Encryption can be Reviewed By: Date:
equal to WEP, changed from 64-bit to
128-bit, and back to 64-
bit; Key Type can be
As Specified Deviation Pass Fail
either HEX or
Passphrase; the Key
and Retype Key fields
are open for user entry
Test Completed by: Date:
List any observed deviations or comments.

Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 133 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 134 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Option: Filter Scan Probe Setup
5.4 Option: Filter Scan Probe Operation Test Action Specified Actual Pass/Fail
1. Connect accessory Filter Scan Probe is
Purpose: probe tubing to sample connected to sample inlet
This section verifies the functionality of the optional use of a filter scan probe. inlet and electrical wiring and DB9 connector
As Specified Deviation Pass Fail
to DB9 Female
Execution Materials, Documents, and Instruments: connection on rear panel
marked AUX. IO
1. User Manual MET ONE 3400 Series
2. Select Sample icon Sample screen is As Specified Deviation Pass Fail
2. Correct Filter scan probe displayed
3. Select Filter Test icon Filter Probe Scan
Test Setup: As Specified Deviation Pass Fail
screen is displayed
1. Verify that the power supply is properly set up and connected. 4. Select Start Filter Sample Pump starts;
2. Unit is powered on. Power Cord icon displays if battery is fully charged. Probe Test button control button changes As Specified Deviation Pass Fail
to red with text Stop
3. Install a zero-count filter on the sample inlet. Filter Probe Test
4. Log in at the Administrator level. 5. If filter available, Electronic light and
5. Check the Counter Navigation>System>System Settings screen to confirm that the 3400 move hand-held probe audible alarm
has been configured so a) that the language for display is English, b) that no sound steadily across filter face indicate presence of As Specified Deviation Pass Fail
at a rate of particles during
parameters are set to None, and c) that the volume is set to an audible level. approximately 4 to 6 sampling.
6. Return to the Counter Navigation screen cm per second
6. Select Stop Filter Sample Pump stops;
Probe Test button control button changes As Specified Deviation Pass Fail
Test Method: to green with text Start
Filter Probe Test
1. Execute the test scripts in section 5.4 Filter Scan Probe Operation and record all the Actual
7. Select Printer icon Printout is generated with
results. Sample actual filter if possible for more effective test results. Date, Time test was
started; Period (duration As Specified Deviation Pass Fail
Note: If a simple particle challenge method is needed in very clean area, consider gently tearing a small of sampling); Count
piece of paper upstream from the probe. Alternately, a source of “canned aerosol” such as compressed Data obtained during the
sampling period
gas for cleaning, IPA or “freeze spray” used to cool electronics can be carefully used to create a
momentary burst of particles to use in testing the function of the Filter Scan Probe. 8. Remove printout; Printout is marked as
mark with Filter Scan Filter Scan Probe As Specified Deviation Pass Fail
Probe Test and save Test and saved with
Acceptance Criteria: with this procedure this procedure
1. Actual is equivalent to Specified. Test Completed by: Date:
List any observed deviations or comments.

Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 135 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 136 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
5.5 Option: FS209E & BS5295 Reports
Note:
1. Because the conversion values used for the manual calculation of the normalized count values may not be
Purpose:
precisely identical to the values and precision used in the instrument’s firmware, small rounding or calculation
This section verifies that the instrument will correctly determine the classifications as dictated by differences may be observed. To simplify the calculations and to save time, the manual calculations below use
the USA FS209E and the British BS 5295 documents. fixed conversion values whereas the instrument will normalize based on the recorded sample volume for each
sample. These differences should be less than 1%. A Pass should be given if the printed and manually
calculated values are less than 1% apart. If a closer match is desired, then the normalized sample data must be
Execution Materials, Documents, and Instruments: calculated based on the sample volume recorded for each specific sample.
1. User Manual MET ONE 3400 Series 2. A short discussion of the mathematics involved for these calculations is given in Appendix Q of this document

Test Setup:
1. Verify that the power supply is properly set up and connected.
2. Verify that at least one battery is installed. The green light for Battery status (below the
Power button) may blink if the battery or batteries are not at full charge. The Battery status
LED should be a steady green light when the installed battery or batteries are fully charged.
These tests can be conducted whether charging is in progress or completed.
3. Verify that the printer has a roll of paper installed with at least half a roll of unused paper
remaining.
4. Unit is powered on. Power Cord icon displays if battery is fully charged.
5. Operator is logged onto Model 3400 as ADMINISTRATOR
6. Check the Counter Navigation>System>System Settings screen to confirm that the 3400
has been configured so that a user login is required, that no sound parameters are set to
None, and that the volume is set to an audible level. Return to the Counter Navigation
screen.
7. Add two additional locations to Area 1 using the Locations> Area/Location Setup. Label the
new locations Location 4 and Location 5 and assign the Location ID as 4 and 5
respectively. Copy the Location 3 settings to locations 4 and 5.
8. Return to the Counter Navigation screen.
9. Touch Lock icon to log off as Administrator.

Test Method:
1. Execute the test scripts in section 5.5.1 Obtaining Sample Data for Tests.
2. Print and save Average report for section 5.5.2 FS209E Report Verification and 5.5.3 BS5295
Report Verification.
3. Execute the test scripts in section 5.5.2 FS209E Report Verification.
4. Execute the test scripts in section 5.5.3 BS5295 Report Verification.

Acceptance Criteria:
1. Actual is equivalent to Specified.
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Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
5.5.1 Obtaining Sample Data for Tests Test Action Specified Actual Pass/Fail
Test Action Specified Actual Pass/Fail 14. Set the Sample Print The Sample Print Mode
As Specified Deviation Pass Fail
Mode to All is set to All
1. Remove zero count Zero count filter is not
As Specified Deviation Pass Fail 15. Set the Print A “check mark” or “tick
filter if installed attached to the unit
Averages function mark” is present in the
2. Log on as an Admin The message Admin As Specified Deviation Pass Fail
box next to Print
Logged on is briefly As Specified Deviation Pass Fail
Averages
displayed
16. Select the Return icon The Counter Navigation
3. On the Counter The System Setting As Specified Deviation Pass Fail
screen appears
Navigation screen, screen is displayed
As Specified Deviation Pass Fail 17. Select the Sample The Sample screen
select the System As Specified Deviation Pass Fail
icon icon appears
4. Select the Options The Options and 18. Select the Settings The Settings tab is now
As Specified Deviation Pass Fail
and Accessories tab Accessories tab is now As Specified Deviation Pass Fail tab on top
on top 19. Touch Quick Settings A message box appears
5. Select the Clear The Clear Sample on the Settings tab to confirm “Are you sure As Specified Deviation Pass Fail
Buffer button Buffer message box is As Specified Deviation Pass Fail you want to continue?”
displayed 20. Select the YES button The message box closes;
6. Select the Yes button The Options and the Sample Setup
As Specified Deviation Pass Fail
Accessories tab is (Default Group) screen
displayed; statement As Specified Deviation Pass Fail appears
Data Buffer: 0 is 21. Program these General
displayed Count Cycles ____________
tab parameters
7. Select the Return icon The Counter Navigation Count Cycles 2 Run Mode ___________
As Specified Deviation Pass Fail Pass Fail
screen appears Run Mode Auto Count Display ___________
8. Select the Historical Message box appears: Count Display Cumulative
icon As Specified Deviation Pass Fail Count Mode ____________
NO DATA Count Mode Counts
9. Select the OK button Message box disappears As Specified Deviation Pass Fail 22. Select the Timing tab Sample Time set to
10. On the Counter The Group Setting and set the Sample 00:01:00 As Specified Deviation Pass Fail
Navigation screen, Management screen is As Specified Deviation Pass Fail Time to 00:01:00
select the Group icon displayed 23. Select the Return icon The Sample screen is
As Specified Deviation Pass Fail
11. Load the Default Active group equals displayed.
As Specified Deviation Pass Fail
group Default 24. Remove any printouts All printouts have been
12. Select the Return icon The Counter Navigation from the front of the removed As Specified Deviation Pass Fail
As Specified Deviation Pass Fail MET ONE 3400
screen appears
13. Select the Printer icon The Print Center screen Test Completed by: Date:
As Specified Deviation Pass Fail
is displayed. List any observed deviations or comments.
Test Completed by: Date:
List any observed deviations or comments.

Reviewed By: Date:


Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 139 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 140 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail Test Action Specified Actual Pass/Fail
25. Verify the sample point Sample point is set to 33. Increment the Location Area 1\Location 5
is set to Area Area 1\Location 1 with the “+” icon to Area displayed As Specified Deviation Pass Fail
As Specified Deviation Pass Fail
1\Location 1, or use 1\Location 5
the “+” button to set 34. Start an Auto sample Sample run begins and
26. Start an Auto sample Sample run begins and run by selecting the Run collects a set of 2
run by selecting the Run collects a set of 2 icon samples before stopping
icon samples before stopping Note: It is acceptable for Count As Specified Deviation Pass Fail
Note: It is acceptable for Count As Specified Deviation Pass Fail Alarm to occur during test;
Alarm to occur during test; audible alarm may be silenced if
audible alarm may be silenced if desired
desired
35. Tear off printout and Printed Average report
27. Increment the Location Area 1\Location 2 mark as 5.5.1 Data Set. marked as 5.5.1 Data Set
with the “+” icon to Area displayed As Specified Deviation Pass Fail Save printout for section and is saved as source As Specified Deviation Pass Fail
1\Location 2 5.5.2 FS209E Report data for 5.5.2 FS209E
28. Start an Auto sample Sample run begins and Verification. Report Verification
run by selecting the Run collects a set of 2 36. Select the Return icon The Counter Navigation
As Specified Deviation Pass Fail
icon samples before stopping screen is displayed
Note: It is acceptable for Count As Specified Deviation Pass Fail
Alarm to occur during test;
37. Select the Test Wizard The Test and Report
audible alarm may be silenced if icon Wizard screen is As Specified Deviation Pass Fail
desired displayed
29. Increment the Location Area 1\Location 3 38. In the Standard drop- FS209E is displayed in
As Specified Deviation Pass Fail
with the “+” icon to Area displayed As Specified Deviation Pass Fail down box select FS209E the Standard field.
1\Location 3 39. Select M7 in the M7 is displayed in the
30. Start an Auto sample Sample run begins and Grade/Class drop-down Grade/Class field. As Specified Deviation Pass Fail
run by selecting the Run collects a set of 2 box
icon samples before stopping 40. Select At Rest in the At Rest is displayed in
Note: It is acceptable for Count As Specified Deviation Pass Fail
Alarm to occur during test;
Occupancy drop-down the Occupancy field As Specified Deviation Pass Fail
audible alarm may be silenced if box
desired
41. Select 0.5 in the Sizes 0.5 is displayed in the
As Specified Deviation Pass Fail
31. Increment the Location Area 1\Location 4 drop-down box. Sizes field
with the “+” icon to Area displayed As Specified Deviation Pass Fail 42. Click the Add button 0.5 is shown in the
1\Location 4 As Specified Deviation Pass Fail
Considered Sizes field.
32. Start an Auto sample Sample run begins and 43. Click the right-facing The Room Area field is
run by selecting the Run collects a set of 2 As Specified Deviation Pass Fail
arrow displayed.
icon samples before stopping
Note: It is acceptable for Count As Specified Deviation Pass Fail 44. Touch the blank Room Keypad appears for data
As Specified Deviation Pass Fail
Alarm to occur during test; Area field entry
audible alarm may be silenced if
desired Test Completed by: Date:
Test Completed by: Date: List any observed deviations or comments.
List any observed deviations or comments.

Reviewed By: Date: Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 141 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 142 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail Test Action Specified Actual Pass/Fail
45. Enter 8 followed by the Room Area now displays 58. Open the Standard BS5295 shown in
Enter button for the Room 8 As Specified Deviation Pass Fail drop-down box and select Standard field. As Specified Deviation Pass Fail
Area BS5295
46. Click the right-facing The Locations field 59. Open the Grade/Class L is shown in the
As Specified Deviation Pass Fail
arrow for the next screen appears drop-down box and select Grade/Class field As Specified Deviation Pass Fail
47. Touch Add Area The Select Area screen L
As Specified Deviation Pass Fail
appears 60. Open the Occupancy At Rest is shown in the
48. Select Area 1 followed Area 1 and Location 1-5 drop-down box and select Occupancy field As Specified Deviation Pass Fail
by OK are shown in the As Specified Deviation Pass Fail At Rest
Locations field. 61. Open the Sizes field 5 is shown in the Sizes
49. Click the right-facing The test criteria is and select the 5 micron field As Specified Deviation Pass Fail
size
arrow displayed ____________
FS209E ____________ 62. Click the Add button 5 is shown in the
Pass Fail As Specified Deviation Pass Fail
M7 Considered Sizes field
____________
At Rest ____________ 63. Click the right-facing The Room Area field is
As Specified Deviation Pass Fail
0.5µ 10000000 arrow displayed.
50. Click the right-facing The Test and Report 64. Enter 8 followed by the Room Area now displays
arrow Wizard screen with the Enter button for the Room 8 As Specified Deviation Pass Fail
As Specified Deviation Pass Fail Area
Begin Sampling button
appears 65. Click the right-facing The Locations field
As Specified Deviation Pass Fail
51. Check or Tick the blank Tick or check mark arrow for the next screen appears
box for Use Existing Data present for Use Existing As Specified Deviation Pass Fail 66. Touch Add Area The Select Area screen
Data As Specified Deviation Pass Fail
button appears
52. Enter the valid dates Dates entered 67. Select Area 1 followed Area 1 and Location 1-5
for Date From and Date As Specified Deviation Pass Fail by the OK button are shown in the As Specified Deviation Pass Fail
To fields. Locations field.
53. Click the right-facing A FS209E Statistics 68. Click the right-facing The test criteria is
As Specified Deviation Pass Fail
arrow report is displayed. arrow displayed ____________
54. Click the Printer icon FS209E Statistics report BS5295 ____________
As Specified Deviation Pass Fail Pass Fail
to print the report is generated and printed. L ____________
55. Tear off the report and Report labeled as At Rest ____________
As Specified Deviation Pass Fail
label FS209E FS209E. 5.00 200000
56. Select the Return icon Counter Navigation 69. Click the right-facing The Test and Report
As Specified Deviation Pass Fail
screen displayed arrow Wizard screen with the
As Specified Deviation Pass Fail
57. Select the Test Wizard Test and Report Wizard Begin Sampling button
As Specified Deviation Pass Fail appears
icon screen displayed
Test Completed by: Date: Test Completed by: Date:

List any observed deviations or comments. List any observed deviations or comments.

Reviewed By: Date:


Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 143 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 144 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail 5.5.2 FS 209E Report Verification
70. Check or Tick the blank Tick or check mark
box for Use Existing Data present for Use Existing As Specified Deviation Pass Fail Test Action Size Ch 1 Size Ch 2 Size Ch 3 Size Ch 4 Size Ch 5 Size Ch 6
Data
1. Multiply the
71. Enter the valid dates Dates entered
cumulative average
for Date From and Date As Specified Deviation Pass Fail
values for Location 1 on
To fields.
the printout labeled 5.5.1
72. Click the right-facing A BS5295 Statistics by 35.3 (for 1 CFM
As Specified Deviation Pass Fail
arrow report is displayed. models), 20 (for 50 LPM
73. Click the Printer icon BS5295 Statistics report models) or 10 (for 100
As Specified Deviation Pass Fail LPM models)
to print the report is generated and printed.
74. Tear off the report and Report labeled BS5295 2. Multiply the
As Specified Deviation Pass Fail cumulative average
label BS5295 and saved
values for Location 2 on
75. Select the Return Counter Navigation
As Specified Deviation Pass Fail the printout labeled 5.5.1
(bent arrow) icon screen displayed
by 35.3 (for 1 CFM
Test Completed by: Date: models), 20 (for 50 LPM
List any observed deviations or comments. models) or 10 (for 100
LPM models)
3. Multiply the
cumulative average
values for Location 3 on
the printout labeled 5.5.1
by 35.3 (for 1 CFM
models), 20 (for 50 LPM
models) or 10 (for 100
Reviewed By: Date: LPM models)
4. Multiply the
cumulative average
values for Location 4 on
the printout labeled 5.5.1
by 35.3 (for 1 CFM
models), 20 (for 50 LPM
models) or 10 (for 100
LPM models)
Test Completed by: Date:
List any observed deviations or comments.

Reviewed By: Date:

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Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Size Ch 1 Size Ch 2 Size Ch 3 Size Ch 4 Size Ch 5 Size Ch 6 Test Action Specified Actual Pass/Fail
5. Multiply the 10. Compare calculated Calculated and printed
cumulative average normalized cumulative normalized cumulative
values for Location 5 on average with printed average values match As Specified Deviation Pass Fail
the printout labeled 5.5.1 average for Location 1 for all sizes within 1%
by 35.3 (for 1 CFM [FS209E]
models), 20 (for 50 LPM
11. Compare calculated Calculated and printed
models) or 10 (for 100
normalized cumulative normalized cumulative
LPM models)
average with printed average values match As Specified Deviation Pass Fail
6. Calculate the mean average for Location 2 for all sizes within 1%
of the cumulative [FS209E]
averages in the
12. Compare calculated Calculated and printed
preceding 5 rows
normalized cumulative normalized cumulative
7. Calculate the average with printed average values match As Specified Deviation Pass Fail
Standard Deviation of average for Location 3 for all sizes within 1%
the cumulative averages [FS209E]
8. Calculate the 13. Compare calculated Calculated and printed
Standard Error normalized cumulative normalized cumulative
average with printed average values match As Specified Deviation Pass Fail
9. Using a Student’s T
average for Location 4 for all sizes within 1%
value of 2.13 (for sample
[FS209E]
results based on 5
locations), calculate the 14. Compare calculated Calculated and printed
95% UCL normalized cumulative normalized cumulative
average with printed average values match As Specified Deviation Pass Fail
Test Completed by: Date:
average for Location 5 for all sizes within 1%
List any observed deviations or comments. [FS209E]
15. Compare calculated Calculated and printed
Mean of the Averages Mean of the Averages
As Specified Deviation Pass Fail
values with printed Mean values match for all
of Averages [FS209E] sizes within 1%
16. Compare calculated Calculated and printed
Standard Deviation Standard Deviation
values with printed values match for all As Specified Deviation Pass Fail
Reviewed By: Date: Standard Deviation sizes within 1%
[FS209E]
Test Completed by: Date:
List any observed deviations or comments.

Reviewed By: Date:

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Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail 5.5.3 BS5295 Report Verification
17. Compare calculated Calculated and printed Test Action Size Ch 1 Size Ch 2 Size Ch 3 Size Ch 4 Size Ch 5 Size Ch 6
Standard Error values Standard Error values
As Specified Deviation Pass Fail 1. Write the normalized
with printed Standard match for all sizes
cumulative average
Error [FS209E] within 1%
values for Location 1
18. Compare calculated Calculated and printed recorded at 5.5.2.1
UCL values with printed UCL values match for As Specified Deviation Pass Fail above
UCL values [FS209E] all sizes within 1%
2. Write the normalized
Test Completed by: Date: cumulative average
values for Location 2
List any observed deviations or comments. recorded at 5.5.2.2
above
3. Write the normalized
cumulative average
values for Location 3
recorded at 5.5.2.3
above
Reviewed By: Date: 4. Write the normalized
cumulative average
values for Location 4
recorded at 5.5.2.4
above
5. Write the normalized
cumulative average
values for Location 5
recorded at 5.5.2.5
above
6. Write the mean of the
cumulative averages
recorded at 5.5.2.6
above
Test Completed by: Date:
List any observed deviations or comments.

Reviewed By: Date:

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Test Action Specified Actual Pass/Fail
7. Compare calculated Calculated and printed
5.6 Option: Partial Data Capture
normalized cumulative normalized cumulative
average with printed average values match As Specified Deviation Pass Fail Purpose:
average for Location 1 for all sizes within 1%
[BS 5295]
This section verifies that the instrument will correctly save and display data records from sample
cycles that are either aborted manually by the operator or stopped due to a system fault such as
8. Compare calculated Calculated and printed a FLOW RATE problem. When this option is not selected, the counter will not save records from
normalized cumulative normalized cumulative
average with printed average values match As Specified Deviation Pass Fail cycles that are incomplete due whether to an operator-based (manual) or system-based
average for Location 2 for all sizes within 1% (automatic) abort of the sample cycle.
[BS 5295]
9. Compare calculated Calculated and printed Execution Materials, Documents, and Instruments:
normalized cumulative normalized cumulative
1. User Manual MET ONE 3400 Series
average with printed average values match As Specified Deviation Pass Fail
average for Location 3 for all sizes within 1%
[BS 5295] Test Setup:
10. Compare calculated Calculated and printed 1. Verify that the power supply is properly set up and connected.
normalized cumulative normalized cumulative 2. Verify that at least one battery is installed. The green light for Battery status (underneath the
average with printed average values match As Specified Deviation Pass Fail
average for Location 4 for all sizes within 1% Power ON/OFF button) may blink if the battery or batteries are not at full charge. The
[BS 5295] Battery status LED should be a steady green light when the installed battery or batteries are
11. Compare calculated Calculated and printed
fully charged. These tests can be conducted whether charging is in progress or completed.
normalized cumulative normalized cumulative 3. Verify that the printer has a roll of paper installed with at least half a roll of unused paper
average with printed average values match As Specified Deviation Pass Fail remaining.
average for Location 5 for all sizes within 1%
4. Unit is powered on.
[BS 5295]
5. If a logon is required, log in at the Adminstrator level
12. Compare calculated Calculated and printed
Mean of the Averages Mean of the Averages 6. Check the Counter Navigation>System>System Settings screens to confirm that the
values with printed values match for all As Specified Deviation Pass Fail 3400 has been configured so that a) a user login is required, b) that each sound parameter
Mean of the Averages sizes within 1% is set to some value other than None, and that c) the volume is set to an audible level.
[BS 5295]
7. On the System>System Settings, Custom tab, verify that there is a checkmark next to the
Test Completed by: Date: Store Partial Data option (option is ENABLED).
List any observed deviations or comments. 8. Return to the Counter Navigation screen.
9. Select the Printer Center icon, verify or set the Sample Print Mode to All.
10. Return to the Counter Navigation screen.
11. Remove any printouts from the printer.
12. If not already executed, log in at the Adminstrator level

Test Method:
1. Execute the test scripts in section 5.6.1
Reviewed By: Date:
Acceptance Criteria:
1. Actual is equivalent to Specified.

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5.6.1 Testing Option: Partial Data Capture Test Action Specified Actual Pass/Fail
Test Action Specified Actual Pass/Fail 12. After a few seconds, Count cycle stops; Stop
stop the sample cycle displayed at top left
1. Remove zero count Zero count filter is not
As Specified Deviation Pass Fail by blocking the sample As Specified Deviation Pass Fail
filter if installed attached to the unit
inlet for about 5
2. On the Counter The Sample screen is seconds
Navigation screen, displayed
As Specified Deviation Pass Fail 13. Examine printout; Messages FLOW
select the Sample
icon messages FLOW ALARM and SAMPLE
ALARM and SAMPLE ABORTED printed at top As Specified Deviation Pass Fail
3. On the Settings tab, Dialog screen is of printout
As Specified Deviation Pass Fail ABORTED printed at
select Quick Settings displayed
top of printout
4. Select the YES button Dialog screen disappears As Specified Deviation Pass Fail
14. Remove printout; mark Printout removed and
5. Select the Timing tab The TIMING tab screen is as PARTIAL marked as PARTIAL As Specified Deviation Pass Fail
As Specified Deviation Pass Fail
displayed RECORD test RECORD test
6. Set the values to Values set to
Sample Time ____________ 15. Printout saved with Printout saved with this
Sample Time 00:01:00 Sample Time 00:01:00 procedure As Specified Deviation Pass Fail
Hold Time ____________ Pass Fail this procedure
Hold Time 00:00:00 Hold Time 00:00:00
Delay time ____________ 16. Select Return (bent Counter Navigation
Delay time 00:00:06 Delay time 00:00:06
arrow) icon to go to screen is displayed
7. Select the Return (bent The Sample screen is As Specified Deviation Pass Fail
As Specified Deviation Pass Fail Counter Navigation
arrow) icon displayed screen
8. Start a sample cycle by Count cycle begins after 17. Select Historical icon Historical screen is
pressing the RUN icon DELAY time expires; As Specified Deviation Pass Fail to go to Historical displayed As Specified Deviation Pass Fail
RUN displayed at top left screen
9. After a few seconds, Count cycle stops; Stop Most recent sample is
displayed at top left 18. Select “-“ button to go
stop the sample cycle displayed As Specified Deviation Pass Fail
As Specified Deviation Pass Fail to most recent sample
by pressing the STOP
icon 19. Verify panel is colored Environmental panel is
red; Sample Aborted! colored red; Sample
10. Examine printout; Message SAMPLE Aborted! message is
message is displayed As Specified Deviation Pass Fail
message SAMPLE ABORTED printed at top displayed at bottom of
of printout As Specified Deviation Pass Fail
ABORTED printed at Environmental panel
top of printout
20. Select “-“ button to go Next sample is displayed
11. Start a sample cycle Count cycle begins after As Specified Deviation Pass Fail
to next stored sample
by pressing the RUN DELAY time expires; As Specified Deviation Pass Fail
icon RUN displayed at top left Test Completed by: Date:

Test Completed by: Date: List any observed deviations or comments.

List any observed deviations or comments.

Reviewed By: Date:


Reviewed By: Date:

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Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail 5.7 Option: Alarm Reasons
21. Verify panel is colored Environmental panel is
green; Sample colored green; Sample Purpose:
Aborted! message is Aborted! message is As Specified Deviation Pass Fail
displayed displayed at bottom of This section verifies that the operator can create custom messages describing data or system
Environmental panel alarms and that these messages can be displayed and printed as part of the data record. If no
22. Select the Return The Counter Navigation messages are present in the list (“null set”) then there will be no opportunity to list a message to
screen is displayed As Specified Deviation Pass Fail further describe the alarm.
(bent arrow) icon
Test Completed by: Date:
Execution Materials, Documents, and Instruments:
List any observed deviations or comments.
1. User Manual MET ONE 3400 Series

Test Setup:
1. Verify that the power supply is properly set up and connected.
2. Verify that at least one battery is installed. The green light for Battery status (underneath the
Power ON/OFF button) may blink if the battery or batteries are not at full charge. The
Battery status LED should be a steady green light when the installed battery or batteries are
Reviewed By: Date: fully charged. These tests can be conducted whether charging is in progress or completed.
3. Verify that the printer has a roll of paper installed with at least half a roll of unused paper
remaining.
4. Unit is powered on.
5. If a logon is required, log in at the Adminstrator level
6. Check the Counter Navigation>System>System Settings screens to confirm that the
3400 has been configured so that a) a user login is required, b) that each sound parameter
is set to some value other than None, and c) that the volume is set to an audible level.
7. On the System>System Settings, Custom tab, verify that there is a checkmark next to the
Store Partial Data option.
8. On the System>System Settings, Basic tab, verify that there is a checkmark next to the
Confirm Sample Batch ID, Comments, and Alarm Reasons option.
9. Return to the Counter Navigation screen.
10. Select the Printer icon, verify or set the Sample Print Mode to All.
11. Return to the Counter Navigation screen.
12. Remove any printouts from the printer.
13. If not already executed, log in at the Adminstrator level

Test Method:
1. Execute the test scripts in section 5.7.1

Acceptance Criteria:
1. Actual is equivalent to Specified.

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Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
5.7.1 Testing Option: Alarm Reasons Test Action Specified Actual Pass/Fail
Test Action Specified Actual Pass/Fail 12. Select the Sample The Sample screen
As Specified Deviation Pass Fail
1. Remove zero count Zero count filter is not icon is displayed
As Specified Deviation Pass Fail
filter if installed attached to the unit 13. Start a sample cycle Count cycle begins after
2. On the Counter The System Settings by pressing the RUN DELAY time expires; As Specified Deviation Pass Fail
Navigation screen, screen is displayed icon RUN displayed at top left
As Specified Deviation Pass Fail
select the System Count cycle stops; Stop
icon 14. After a few seconds,
stop the sample cycle displayed at top left
3. On the Options and The message screen As Specified Deviation Pass Fail
by pressing the stop
Accessories tab, Clear Sample Buffer As Specified Deviation Pass Fail icon
select the Clear is displayed
Buffer button 15. Examine printout; Message SAMPLE
message SAMPLE ABORTED printed at
4. Select Yes Clear Sample Buffer As Specified Deviation Pass Fail
ABORTED printed at top of printout
screen disappears; As Specified Deviation Pass Fail
Data Buffer value is 0. top of printout
5. Select the Units and The Units and Alarms 16. Examine display; Message screen titled
As Specified Deviation Pass Fail Unassigned Alarms is
Alarms tab screen is displayed message screen titled
displayed. As Specified Deviation Pass Fail
6. Select the Reasons Alarm Reasons Unassigned Alarms
As Specified Deviation Pass Fail is displayed.
icon screen appears
7. Select the Add button The Enter 17. Select Yes; message View Buffered Data
Note: If the alarm reason Alarm Reason screens disappears screen is displayed
list already has the As Specified Deviation Pass Fail
screen is As Specified Deviation Pass Fail and View Buffered
maximum of 6 entries,
delete any 1 of them before
displayed Data screen appears.
proceeding with next step. 18. Select “-“ button to go Most recent sample is
displayed As Specified Deviation Pass Fail
8. Enter Operator Text string Operator to most recent sample.
stopped sample stopped sample As Specified Deviation Pass Fail Environmental panel is
19. Verify panel is colored
cycle as text; select cycle appears in list colored green; Sample
green; Sample
Enter button box Aborted! message is As Specified Deviation Pass Fail
Aborted! message is
9. Select the arrow on The drop-down box displayed displayed at bottom of
the drop-down box opens. After Required Environmental panel
in the lower right selected, list closes As Specified Deviation Pass Fail
20. Select the area on the The Alarm Reasons
corner; select and Required is
screen where the screen is displayed
Required displayed. As Specified Deviation Pass Fail
message Sample
10. Select the Return The System Settings Aborted! is displayed
(bent arrow) icon screen is displayed As Specified Deviation Pass Fail
Test Completed by: Date:

The Counter List any observed deviations or comments.


11. Select the Return
(bent arrow) icon Navigation As Specified Deviation Pass Fail
screen is displayed
Test Completed by: Date:
List any observed deviations or comments.

Reviewed By: Date:


Reviewed By: Date:

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Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail
21. Select the text Dialog screen appears to 5.8 Option: Batch ID
Operator stopped verify selection
sample cycle; then As Specified Deviation Pass Fail Purpose:
select the Return
This section verifies that the operator can create custom text strings of up to 29 characters to label a
(bent arrow) icon
sample series and that these messages can be displayed and printed as part of the data record. If no
22. Select Yes Dialog screen disappears As Specified Deviation Pass Fail messages are present in the field (“null set”) then no text string will be displayed or printed.
23. Select OK Message screen titled
Unassigned Alarms As Specified Deviation Pass Fail
disappears
Execution Materials, Documents, and Instruments:
1. Met One 3400 series counter
24. Select Return arrow Sample screen is
displayed As Specified Deviation Pass Fail 2. User Manual MET ONE 3400 Series
3. 1 or more rolls of printer paper
25. Select Return (bent Counter Navigation
arrow) icon to go to screen is displayed
As Specified Deviation Pass Fail
Counter Navigation Test Setup:
screen. Note:
26. Select the Printer The Print Center screen When there is a possibility to enable or disable a function on the particle counter, the
As Specified Deviation Pass Fail
icon. is displayed presence of a checkmark 9 within the adjacent box ; indicates that the function is
The Printing message is ENABLED; an empty box … indicates the function is DISABLED.
27. Select the Buffer icon. As Specified Deviation Pass Fail
momentarily displayed
28. Printout is generated Printout contains Alarm 1. Verify that the power supply is properly set up and connected.
with Alarm Reason Reason entry followed 2. Verify that at least one battery is installed.
As Specified Deviation Pass Fail
entry printed. by text Operator 3. Verify that the printer has a roll of paper installed with at least half a roll of unused paper remaining.
stopped sample cycle
4. Unit is powered on.
29. Remove printout; mark Printout removed 5. If a logon is required, log in at the Adminstrator level
as ALARM REASON and marked as
As Specified Deviation Pass Fail 6. Check the Counter Navigation>System>System Settings screens, Basic tab, to confirm that the
test. ALARM REASON
test 3400 has been configured so that a) User Logon Required is ENABLED, and b) Confirm Sample
Batch ID, Comments, and Alarm Reasons is ENABLED.
30. Printout attached to Printout attached to
this procedure As Specified Deviation Pass Fail 7. On the System>System Settings screens, Sounds tab, verify that each sound parameter is a) set
this procedure.
to some value other than None, and b) that the volume is set to an audible level.
31. Select Return (bent Counter Navigation
8. On the System>System Settings screens, Custom tab, verify that the Store Partial Data option is
arrow) icon to go to screen is displayed As Specified Deviation Pass Fail
ENABLED
Counter Navigation
9. Return to the Counter Navigation screen.
Test Completed by: Date: 10. Select the Printer icon, verify or set the Sample Print Mode to All.
List any observed deviations or comments. 11. Return to the Counter Navigation screen.
12. Remove any printouts from the printer.

Test Method:
1. Execute the test scripts in section 5.8.1

Reviewed By: Date: Acceptance Criteria:


1. Actual is equivalent to Specified.

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Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
5.8.1 Testing Option: Batch ID entry Test Action Specified Actual Pass/Fail
Test Action Specified Actual Pass/Fail 15. Select Yes The Sample Setup As Specified Deviation Pass Fail
screen is displayed
1. Remove zero count filter Zero count filter is not
As Specified Deviation Pass Fail 16. Select the Timing tab The TIMING tab screen
if installed attached to the unit As Specified Deviation Pass Fail
is displayed
2. On the Counter The System Settings
As Specified Deviation Pass Fail 17. Set the values to Values set to Sample Time ____________
Navigation screen, screen is displayed
select the System icon Sample Time 00:01:00 Sample Time 00:01:00 Hold Time ____________ Pass Fail
3. On the Options and The message screen Hold Time 00:00:00 Hold Time 00:00:00 Delay time ____________
Accessories tab, Clear Sample Buffer Delay time 00:00:06 Delay time 00:00:06
As Specified Deviation Pass Fail
select the Clear Buffer is displayed 18. Select the Return The Sample screen
button As Specified Deviation Pass Fail
(bent arrow) icon is displayed
4. Select Yes Clear Sample Buffer
screen disappears; As Specified Deviation Pass Fail 19. Start a sample Count cycle begins after
Data Buffer value is 0. cycle by pressing DELAY time expires;
As Specified Deviation Pass Fail
the RUN icon RUN displayed at top
5. Select the Units and The Units and Alarms As Specified Deviation Pass Fail left
Alarms tab screen is displayed
6. Select the Reasons Alarm Reasons 20. After a few seconds, Count cycle stops; Stop
As Specified Deviation Pass Fail stop the sample displayed at top left
icon screen appears As Specified Deviation Pass Fail
The drop-down box cycle by pressing the
7. Select the arrow on the
opens. After Disabled STOP icon
drop-down box in the As Specified Deviation Pass Fail
lower right corner; selected, list closes; 21. Examine printout; Message SAMPLE
select Disabled Disabled is displayed. message SAMPLE ABORTED printed at
As Specified Deviation Pass Fail
The System Settings ABORTED printed top of printout
8. Select the Return As Specified Deviation Pass Fail
(bent arrow) icon screen is displayed at top of printout
9. Select the Return The Counter Navigation 22. On the Settings tab, Enter Batch ID screen
As Specified Deviation Pass Fail As Specified Deviation Pass Fail
(bent arrow) icon screen is displayed press Batch ID is displayed
10. On the Counter The Sample screen 23. Enter the text The entry box contains
Navigation screen, is displayed As Specified Deviation Pass Fail TEST BATCH 001 the text string TEST As Specified Deviation Pass Fail
select the Sample icon BATCH 001
11. On the Settings tab, Enter Batch ID screen 24. Select the Enter button The Sample screen is As Specified Deviation Pass Fail
press underlined is displayed displayed
phrase displayed As Specified Deviation Pass Fail
25. Verify the string The string TEST BATCH
below Quick Settings TEST BATCH 001 is 001 is now displayed
Note: usually Batch ID As Specified Deviation Pass Fail
now displayed below below QUICK SETTINGS
12. Select the DEL button The entry box is empty As Specified Deviation Pass Fail QUICK SETTINGS
of text characters Message screen Batch
26. Start a sample cycle by As Specified Deviation Pass Fail
13. Select the Enter The Sample screen pressing the RUN icon Begin is displayed
As Specified Deviation Pass Fail
button is displayed
Test Completed by: Date:
14. Select the Quick Message box is
Settings text on displayed to As Specified Deviation Pass Fail List any observed deviations or comments.
the Settings tab confirm choice
Test Completed by: Date:
List any observed deviations or comments.

Reviewed By: Date:

Reviewed By: Date:

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Test Action Specified Actual Pass/Fail
27. Select the EDIT ID The Enter Batch ID 5.9 Option: PDF/Excel Real-time USB Data Output
As Specified Deviation Pass Fail
button screen is displayed
28. Enter the text The entry box contains
TEST BATCH 002 the text string TEST As Specified Deviation Pass Fail Purpose:
BATCH 002 This section verifies data output setup and operation on the MET ONE 3400 by testing the relevant
functions of the counter and subsequent real-time data output in the form of PDF and .csv files.
29. Select the Enter The Enter Batch ID
button screen disappears;
message screen appears As Specified Deviation Pass Fail Execution Materials, Documents, and Instruments:
“Are you aure you wish
to proceed using Batch 1. Met One 3400 series counter
ID: Test Batch 002”? 2. User Manual MET ONE 3400 Series
30. Select the Yes The message screen 3. Zero count filter
button disappears; count cycle As Specified Deviation Pass Fail 4. Computer station with at least one open USB port
begins 5. USB Flash Drive with at least 100 MB of available free space. A completely blank USB Flash Drive
31. After at least 10 Count cycle stops; Stop is preferred whenever possible.
seconds, stop the displayed at top left 6. 1 or more rolls of printer paper
sample cycle by As Specified Deviation Pass Fail
pressing the
STOP icon Test Setup:
32. Examine printout; Message SAMPLE Note:
message SAMPLE ABORTED printed at top When there is a possibility to enable or disable a function on the particle counter, the
As Specified Deviation Pass Fail
ABORTED printed of printout presence of a checkmark 9 within the adjacent box ; indicates that the function is
at top of printout ENABLED; an empty box … indicates the function is DISABLED.
33. Examine printout; entry BATCH ID printed
for BATCH ID printed followed by TEST 1. Verify that the power supply is properly set up and connected.
As Specified Deviation Pass Fail
followed by TEST BATCH 002
BATCH 002 2. Met One 3400 is powered on. Install batteries if commonly used but battery operation is not
mandatory for this process.
34. Remove printout; Printout removed and
mark as BATCH ID marked as BATCH ID As Specified Deviation Pass Fail 3. Verify that the printer has a roll of paper installed with at least half a roll of unused paper remaining.
test test
4. Go to Counter Navigation>System>System Settings, Custom tab. Verify that the Basic Mode is
35. Printout saved Printout saved with this DISABLED and that Hide Mode Prompt is ENABLED.
with this procedure As Specified Deviation Pass Fail
procedure
5. Confirm that PDF functionality has been activated by verifying the presence of a tab under
System>System Settings titled PDF
36 On message screen Message screen
Batch End, select No disappears, Test Batch 6. Verify or set the following parameters on the PDF tab screen so that a check mark (tick mark) is
As Specified Deviation Pass Fail
002 still displayed below visible in the selection box:
Quick Settings.
a. PDF on USB detect
Test Completed by: Date: b. Export Averages
List any observed deviations or comments. c. Export to EXCEL
d. Warn when USB drive is XX % full
e. Warn on missing USB
7. IMPORTANT: Save existing configuration !!!
Reviewed By: Date: To save the current configuration, install a USB Flash Drive in the front panel port of the Met One
3400. Go to the Counter Navigation>System>System Settings, Configuration tab. Press the
Copy Configuration to USB button on the screen. If needed, acknowledge screen at end of
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transfer. Remove the USB drive when the process is completed. The existing configuration can be 19. Select the RETURN (bent arrow) icon in the lower left corner of the screen to return to the
restored at the end of this test procedure using this stored configuration. Sample Location Setup screen, then RETURN again to return to the Area/Location Setup
8. Under Counter Navigation>System>System Settings, go to Basic tab screen to confirm that the screen.
3400 has been configured so a) User Logon Required is DISABLED, b) values for Date and Time 20. Under the AREA named PDF Test, create another new LOCATION entry:
are set correctly, c) Sleep Time and Backlight Timeout are set to 0, and d) Confirm Sample
Batch ID, Comments, and Alarm Reasons is DISABLED. Next, access the Options and - Location Name = PDF Test 2
Accessories tab to verify d) that the language for display is English, and finally go to the Sounds - Location ID = 2
tab screen to verify that e) that no sound parameters are set to None and f) that the volume is set to 21. Select the Settings icon, and set the following specifications for this location (same settings
an audible level. as for PDF Test 1):
9. Select the Units and Alarms tab; select the Reasons icon. Select Disabled on the drop- down - On the General tab
window in the lower right corner. a. Count Cycles = 3
10. Select the RETURN icon in the lower left corner of the screen to go to the SystemSettings screen. b. Run Mode = Auto
11. Select the Options and Accessories tab; select the Clear Buffer button c. Count Display = Cumulative
d. Count Mode = Counts
CAUTION:
- On the Timing tab
If there is a need to save any of the existing data, a. Sample Time = 00:00:10
be sure to print or export the buffered data before executing this step. b. Hold Time = 00:00:05
c. Delay time = 00:00:06
Touch the Yes button to clear the buffer. The value for the Data Buffer should now be “0”
12. Select the RETURN (bent arrow) icon in the lower left corner of the screen to go to the Counter
Navigation screen. 22. When finished, select the RETURN icon; select the Alarms icon and set a COUNT ALARM for the
13. Select the Printer icon, then verify or set the Sample Print Mode to All. Verify or set the Cycle Print first size to a value of 1000.
Order to 1-10. Verify that there is no check mark/tick mark in the box for Print Averages or else set 23. When finished, select the RETURN icon two times to go to the Counter Navigation screen.
box to empty state.
14. Select the RETURN (bent arrow) icon in the lower left corner of the screen to go to the Counter 24. Select the GROUP icon. Delete any existing groups except for the DEFAULT group.
Navigation screen.
Create a new group, PDF TEST. Touch the LOAD button to make it the active group then touch
15. Select the LOCATIONS icon. Use the Remove Area and/or Remove Location button to remove all
the SETTINGS button. On the Group Settings screen, set a check mark/ tick mark in the Use
AREAS or LOCATIONS that exist.
Location Settings box. Use the Add Location button to add the area PDF Test. Both PDF Test
16. Create new AREA named PDF Test. Under this AREA add a new LOCATION entry:
1 and PDF Test 2 should now be displayed within the Locations box.
- Location Name = PDF Test 1
- Location ID = 1
25. When finished, select the RETURN (bent arrow) icon in the lower left corner of the screen to go to
17. Select the Settings icon, and set the following specifications for this location: the Group Setting Management screen. Select the RETURN (bent arrow) icon again to go to the
- On the General tab Counter Navigation screen.

a. Count Cycles = 3 26. Remove any printouts from the printer; discard or file separately
b. Run Mode = Auto 27. Install the zero-count filter on the sample inlet if not already in place.
c. Count Display = Cumulative
d. Count Mode = Counts
Test Method:
- On the Timing tab 1. Execute the test scripts in section 5.9.1 PDF/EXCEL Data Output and record all the Actual results.
a. Sample Time = 00:00:10
b. Hold Time = 00:00:05 Acceptance Criteria:
c. Delay time = 00:00:06 1. Actual is equivalent to Specified.
18. Select the RETURN (bent arrow) icon in the lower left corner of the screen to return to the Sample
Location Setup screen. Select the Alarms icon, and set the Count Limit for the first size to 1000.

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 165 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 166 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail
5.9.1 Testing Option: PDF/EXCEL Real-time USB Data Output
9. Type pdf_test, followed The letters pdf_test appear in As Specified Deviation Pass Fail
Test Action Specified Actual Pass/Fail by the Enter key. the Text window
1. From the current screen, The System Settings screen is As Specified Deviation Pass Fail 10. Use the dropdown The word (space) appears in
select the System icon displayed. selection box to set the the As Specified Deviation Pass Fail
value of the Field Field Separator window
2. Select the PDF tab The PDF screen appears in As Specified Deviation Pass Fail Separator to be (space)
the foreground of the display
11. Touch the Return (bent The Counter Navigation
3. Use the New Document Location Change is displayed arrow) icon two times to screen is displayed.
On drop-down to select in the drop-down box As Specified Deviation Pass Fail
return to the Counter
Location Change As Specified Deviation Pass Fail Navigation window
Note: Make sure the Use
Date box is not selected 12. Touch the SAMPLE icon The SAMPLE As Specified Deviation Pass Fail
screen is displayed.
4. Touch the window area A new screen appears with
13. Use the Settings tab to Sample parameters are: Group = ____________
next to the phrase Output the words Enter a folder As Specified Deviation Pass Fail
verify the sample setup. Group = PDF TEST Cycles = ___________
File Folder name to store PDF files at
Cycles = 3
the top Note: If needed, clear any Delay = ____________
existing characters from Delay = 00:00:06 Pass Fail
5. Enter the words “test pdf The entry screen disappears BATCH ID by touching the Hold = 00:00:05 Hold = ____________
function” and press the and the words “test pdf words Batch ID and Sample = 00:00:10 Sample = ____________
As Specified Deviation Pass Fail removing any entry on the
ENTER button function” appear in the Output Enter Batch ID screen.
Batch ID = (null) or (empty) Batch ID = ____________
File Folder window
14. Verify that there is no USB USB Flash Drive is
6. Touch the Configure File A new window appears with Flash drive inserted on the not installed. As Specified Deviation Pass Fail
Name button the title Configure File Name As Specified Deviation Pass Fail
front panel.
on top
15. Start a sample run by Pump starts and (3) runs are
7. Using the dropdown Seven (7) dropdown boxes pressing the green executed. Message box
selection windows, enter are displayed showing this START icon. appears, stating that an error
the following series of sequence: Area, Location, Note: during one or more of the occurred while attempting to
choices to build a file Date, Time, User Name, As Specified Deviation Pass Fail
runs, temporarily remove the zero- save PDF file.
name: Area, Location, Serial, Text As Specified Deviation Pass Fail count filter to allow particles to be
Date, Time, User Name, counted. For at least one run,
allow at least 1000 particles to be
Serial, Text sampled, triggering alarm event.
Note: If any entries already exist,
enter <None> to clear previous 16. Remove paper printout and Paper printout is removed
selections.
mark as “1st run; no USB and marked as “1st run; no As Specified Deviation Pass Fail
8. Touch the window area A new screen appears with the drive” and save with USB drive”; saved with
next to the word Text words Enter a text label to be procedure procedure
As Specified Deviation Pass Fail
used in PDF file names at the 17. On message box, press Message box closes and
top As Specified Deviation Pass Fail
“OK” on upper right corner. SAMPLE screen is in view.
Test Completed by: Date: Test Completed by: Date:
List any observed deviations or comments. List any observed deviations or comments.

Reviewed By: Date:


Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 167 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 168 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail Test Action Specified Actual Pass/Fail

18. Touch the Return (bent The Counter Navigation 30. Press the Export button File Export screen appears;
arrow) icon to go to screen is displayed. As Specified Deviation Pass Fail progress reporting with As Specified Deviation Pass Fail
Counter Navigation entries: Building file;
Uploading file Validating file;
19. Touch the Historical icon The View Buffered Data As Specified Deviation Pass Fail
screen is displayed. 31. Export transfer Message box disappears and
complete the View Buffered Data screen As Specified Deviation Pass Fail
20. Touch the Printer icon near The Print Center As Specified Deviation Pass Fail is displayed.
the bottom of the screen. screen is displayed.
32. Remove USB drive; install Printed page is marked Printed
21. Touch the Buffer icon Printout of 1st run As Specified Deviation Pass Fail into computer or printer and
st
PDF: 1 run no USB drive
data is generated. As Specified Deviation Pass Fail
print out file named pdf 1st
22. Remove paper printout Paper printout is removed and run no usb.PDF
and mark as “Buffer: 1st marked as “Buffer: 1st run; no As Specified Deviation Pass Fail 33. Compare data and alarm All data entries and alarm
run; no USB drive” and USB drive”; saved with markings for all three runs status agree.
save with procedure procedure among the (2) paper tape Note: Not all information on
printouts is available on View
As Specified Deviation Pass Fail
23. Touch RETURN (bent The View Buffered Data printouts, PDF printed
As Specified Deviation Pass Fail Buffered Data screen but count
arrow) icon screen is displayed. page and View Buffered data and alarm status should
Data screen agree.
24. Touch the Export icon The Export Sample Data
(near bottom of screen screen is displayed. As Specified Deviation Pass Fail 34. Re-install a USB Flash USB Flash Drive is present
with red arrow) Drive in the port on the in front panel port of As Specified Deviation Pass Fail
USB Flash Drive - Not Installed front of the instrument instrument
25. Set Export to: USB Flash As Specified Deviation Pass Fail
Drive - Not Installed is selected 35. Touch the Return (bent The Counter Navigation
arrow) icon to return to screen is displayed. As Specified Deviation Pass Fail
26. Set the file type to PDF From the list under Output File As Specified Deviation Pass Fail Counter Navigation
Type, select PDF
36. Touch the Printer icon The Print Center As Specified Deviation Pass Fail
27. Touch the window next to Entry screen marked Enter As Specified Deviation Pass Fail screen is displayed.
FILE NAME Export Filename appears
37. Place a check mark/tick A check mark/tick mark is
28. Use the letter keys to The phrase pdf 1st run no mark in the box next to present in the box next to As Specified Deviation Pass Fail
enter the title pdf 1st run USB appears in the As Specified Deviation Pass Fail Print Averages Print Averages.
no USB; press the ENTER window next to FILE NAME
button 38. Touch the Return (bent The Counter Navigation
arrow) icon to return to screen is displayed. As Specified Deviation Pass Fail
29. Install a USB Flash Drive After a short interval, the red
Counter Navigation
in the port on the front of lettering disappears and USB As Specified Deviation Pass Fail
the instrument Flash Drive - Installed 39. Touch the SAMPLE icon The SAMPLE As Specified Deviation Pass Fail
message is displayed screen is displayed.
Test Completed by: Date: Test Completed by: Date:
List any observed deviations or comments. List any observed deviations or comments.

Reviewed By: Date:


Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 169 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 170 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail
40. Touch the “+” icon The location name changes to As Specified Deviation Pass Fail
PDF Test 2 5.10 RS232 port operation
41. Start a sample run by Pump starts and (3) runs are
pressing the green executed. Message box Purpose:
START icon. appears briefly after third run This section verifies serial communications interface with the MET ONE 3400 by testing the
Note: during one or more of the completes, warning not to As Specified Deviation Pass Fail function of the RS232 port
runs, temporarily remove the zero- remove USB drive during the
count filter to allow particles to be
counted. For at least one run,
process of saving PDF file.
allow at least 1000 particles to be Execution Materials, Documents, and Instruments:
sampled, triggering alarm event.
1. User Manual MET ONE 3400 Series
42. Remove paper printout Paper printout is removed 2. Zero count filter
and mark as “2nd run; and marked as “2nd run; USB As Specified Deviation Pass Fail
USB installed” and save installed””; saved with 3. Computer or terminal with one or more open RS-232 or USB ports
with procedure procedure 4. USB<>Serial adapter cable or RS-232 cable from computer or terminal with correct
43. Remove USB drive; install Printed page is marked Printed connector and null modem adapter (when required; see Appendix R)
into computer or printer; PDF: 2nd run; USB installed 5. Serial communications software such as ProComm, TeraTerm or equivalent, set to
open folder marked test pdf As Specified Deviation Pass Fail operate through the USB<>serial adaptor or RS-232 cable with these settings:
function and print out PDF
file. Mark as Printed PDF: a. parity = none
2nd run; USB installed b. data bits = 8
44. Compare data and alarm All data entries and alarm c. stop bits = 1
markings for all three runs status agree. d. baud rate = 9600
among the (2) paper tape Note: Not all information on
printouts is available on View
As Specified Deviation Pass Fail
printouts, PDF printed
Buffered Data screen but count Test Setup:
page and View Buffered data and alarm status should
Data screen agree. 1. Verify that the Met One 3400 power supply is properly set up and connected.
NOTE: 2. Met One 3400 is powered on.
As needed, restore the original configuration. Install the USB drive on which that configuration was saved. Go to
SYSTEM>SYSTEM SETTINGS>CONFIGURATION and press the READ CONFIGURATION FROM USB button. Remove
3. Verify that at least one battery is installed. The green light for Battery status (below the
USB drive when complete. Power button) may blink if the battery or batteries are not at full charge. The Battery
status LED should be a steady green light when the installed battery or batteries are fully
Test Completed by: Date:
charged. Note: These tests can be conducted whether charging is in progress or
List any observed deviations or comments. completed.
4. Verify that the printer has a roll of paper installed with at least half a roll of unused paper
remaining.
5. Check the Counter Navigation>System>System Settings screen to confirm that the
3400 has been configured so a) no user login is required, b) values for Date and Time
are set correctly, c) Sleep Time and Backlight Timeout are set to 0, d) that the
language for display is English, e) that no sound parameters are set to None and f)
that the volume is set to an audible level.
Reviewed By: Date:
6. Select the Options and Accessories tab; select the Clear Buffer button and then select
Yes to clear the buffer.
7. Select the RETURN (bent arrow) icon in the lower left corner of the screen to go to the
Counter Navigation screen.
8. Install the zero-count filter on sample inlet if not already in place.

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 171 of 223
Edition 6.5 Released June 2013 For proprietary use only. IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 172 of 223
Edition 6.5 Released June 2013 For proprietary use only.
Test Method: 5.10.1 Testing Option: RS232 Port Operation
1. Execute the test scripts in section 5.10.1 Testing Option: RS232 Port Operation and Test Action Specified Actual Pass/Fail
record all the Actual Results.
1. From the current screen, The Communication Settings
As Specified Deviation Pass Fail
select the Network icon screen is displayed.
Acceptance Criteria: 2. Select the Serial tab The Serial screen appears in
1. Actual is equivalent to Specified. As Specified Deviation Pass Fail
the foreground of the display
3. Touch the circular area to A black dot is within the white
the left of FX circular area and a dotted
As Specified Deviation Pass Fail
outline box surrounds the
word FX
4. Select the FX ID: field The Enter FX ID screen
As Specified Deviation Pass Fail
appears
5. Select 0 then press the The Communication Settings
Enter button screen is displayed; FX ID: As Specified Deviation Pass Fail
value is 0.
6. Select the small arrow on A dropdown selection window
the right side of the Baud appears with numeric entries of As Specified Deviation Pass Fail
Rate dropdown several baud rates
7. Touch the number 9600 in The dropdown window closes
the dropdown window and 9600 is displayed in the As Specified Deviation Pass Fail
Baud Rate window
8. Touch the circular area to A black dot is within the white
the left of RS-232 circular area and a dotted box As Specified Deviation Pass Fail
surrounds the word RS-232
9. Touch the square box to An error tone sounds; Screen
the left of the words does not change. As Specified Deviation Pass Fail
Manifold Support
10. Touch the square box to An error tone sounds; Screen
the left of the words Auto does not change. As Specified Deviation Pass Fail
Increment Port

Test Completed by: Date:


List any observed deviations or comments.

Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 173 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 174 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail Test Action Specified Actual Pass/Fail

11. Select the RETURN (bent The Counter Navigation 19. Verify that the serial Software is running and can
arrow) icon screen is displayed. As Specified Deviation Pass Fail communication software locate Met One 3400
(ProComm, TERATERM As Specified Deviation Pass Fail
or similar) is set for the
12. From the current screen, The Sample screen is correct port
select the Sample icon displayed. As Specified Deviation Pass Fail 20. Type a capital letter “U” in Capital letter “U” is seen in the
the transmit window of the transmit window, then “A”;
software, followed by the response from counter is a
13. Select the Settings tab, A message box appears “You As Specified Deviation Pass Fail
capital letter “A” “pound” or “hash” sign (“#”)
and then Quick Settings are about to edit the settings…” As Specified Deviation Pass Fail Note:
Do not type the quotation (“”) marks

14. Select the YES button The message box disappears 21. Type a lower case “c”, Typed letters are seen in
and the Sample Setup As Specified Deviation Pass Fail pause for 4 or 5 seconds, transmit window; pump starts
(“groupname”) appears then type “ehA” on counter; data record As Specified Deviation Pass Fail
Note: appears in software; pump is
15. Select the dropdown Counts is displayed in the Do not type the quotation (“”) marks stopped
arrow under Count Mode; window under Count mode As Specified Deviation Pass Fail 22. Compare the count data Data match
then select Counts
on the Sample screen and
As Specified Deviation Pass Fail
the data record shown in
16. Select the dropdown Cumulative is displayed in the
the software window
arrow under Count window under Count display
As Specified Deviation Pass Fail
Display; then select Test Completed by: Date:
Cumulative
List any observed deviations or comments.
17. Select the RETURN (bent The Sample screen is
arrow) icon displayed. As Specified Deviation Pass Fail

18. Verify that the correct type Cabling is in place to connect


of cable is connected from computer or terminal to Met
the computer or terminal One 3400 particle counter
to the DB9 connector on As Specified Deviation Pass Fail
the rear panel marked Reviewed By: Date:
either Manifold or
RS232/Manifold
Test Completed by: Date:

List any observed deviations or comments.

Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 175 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 176 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
5.11 Option: Sample Comments 13. Select the Printer icon, verify or set the Sample Print Mode to All and Cycle Print Order
to 10-1.
Purpose: 14. Using the Return icon, return to the Counter Navigation screen.
This section verifies that the operator can create custom messages describing data and that 15. If not already executed, log on as Administrator.
these messages can be displayed and printed as part of the data record. If no preset 16. Remove any printouts from the printer.
messages are present in the list (“null set”) then there is an opportunity for the user to create a
message to further describe the sample.

Execution Materials, Documents, and Instruments:


4. Met One 3400 series counter Test Method:
5. User Manual MET ONE 3400 Series 1. Execute the test scripts in section 5.11.1
6. 1 or more rolls of printer paper
Acceptance Criteria:
Test Setup: 1. Actual is equivalent to Specified.
Note:
When there is a possibility to enable or disable a function on the particle counter, the
presence of a checkmark 9 within the adjacent box ; indicates that the function is
ENABLED; an empty box … indicates the function is DISABLED.

1. Verify that the power supply is properly set up and connected.


2. Verify that at least one battery is installed. The green light for Battery status (underneath
the Power ON/OFF button) may blink if the battery or batteries are not at full charge. The
Battery status LED should be a steady green light when the installed battery or batteries
are fully charged. These tests can be conducted whether charging is in progress or
completed.
3. Verify that the printer has a roll of paper installed with at least half a roll of unused paper
remaining.
4. Touch front panel POWER button to turn ON. Counter will boot-up to Counter Navigation
screen. If required, log on as Administrator.
5. On the Counter Navigation screen, select the System icon.
6. On the Sounds tab, verify that each sound parameter is set to some value other than None
and that the volume is set to an audible level.
7. On the Basic tab, ENABLE both User Logon Required and the Confirm Sample Batch
ID, Comments and Alarm Reasons options.
8. On the Custom tab, ENABLE the Store Partial Data option.
9. On the PDF tab, DISABLE the PDF on USB detect option.
10. On the Units and Alarms tab, select the Reasons (“bell”) icon. Using the drop-down
menu at the lower right corner, set the value to Disabled.
11. Using the Return (bent arrow) icon, return to the System Settings screen.
12. Using the Return again, return to the Counter Navigation screen.

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 177 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 178 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
5.11.1 Testing Option: Sample Comments Test Action Specified Actual Pass/Fail
Test Action Specified Actual Pass/Fail 12. Select Yes Message screen disappears;
SAMPLE SETUP screen As Specified Deviation Pass Fail
1. Remove zero count filter if Zero count filter is not
As Specified Deviation Pass Fail appears
installed attached to the unit
2. On the Counter The System Settings screen 13. Select the Timing tab The TIMING tab screen is
As Specified Deviation Pass Fail
Navigation screen, select is displayed As Specified Deviation Pass Fail displayed
the System icon 14. Set the values to Values set to Sample Time ____________
3. On the Options and The message screen Sample Time 00:00:10 Sample Time 00:00:10 Hold Time ____________ Pass Fail
Accessories tab, select Clear Sample Buffer is As Specified Deviation Pass Fail Hold Time 00:00:00 Hold Time 00:00:00 Delay time ____________
the Clear Buffer button displayed Delay time 00:00:06 Delay time 00:00:06
4. Select Yes Clear Sample Buffer 15. Select the General tab The General tab screen is As Specified Deviation Pass Fail
screen disappears; Data As Specified Deviation Pass Fail displayed
Buffer value is 0. 16. Set the values to Values set to Count Cycles ____________
5. Select the Sample Sample Comment screen As Specified Deviation Pass Fail Count Cycles 3 Count Cycles 3
Comments icon appears Run Mode ____________
Run Mode Auto Run Mode Auto Pass Fail
Count Display ____________
6. Select the Add button The Enter Sample Comment Count Display Cumulative Count Display Cumulative
Note: If the list already has the screen is displayed Count Mode ______________
maximum of 16 entries, delete As Specified Deviation Pass Fail Count Mode Counts Count Mode Counts
any 1 of them before 17. Select the Return The Sample screen is
proceeding with next step.
As Specified Deviation Pass Fail
icon displayed
7. Enter test message 1 Text string test message 1 18. Start a sample cycle by Count cycle begins after
as text; select Enter appears in list box As Specified Deviation Pass Fail pressing the RUN icon DELAY time expires; RUN As Specified Deviation Pass Fail
button displayed at top left
8. Select the arrow on the The drop-down box opens. Count cycle stops; Stop
19. After a few seconds,
drop-down box in the After Required selected, displayed at top left As Specified Deviation Pass Fail
As Specified Deviation Pass Fail stop the sample cycle by
lower right corner; list closes and Required is
pressing the stop icon
select Required displayed.
20. Examine printout; Message SAMPLE
Select the RETURN (bent The System Settings ABORTED printed at top of
As Specified Deviation Pass Fail message SAMPLE As Specified Deviation Pass Fail
arrow) icon screen is displayed printout
ABORTED printed at top
9. Select Return again The Counter Navigation of printout
As Specified Deviation Pass Fail
screen is displayed Message screen titled
21. Examine display;
10. Select the Sample The Sample screen is message screen titled Sample Comment is
As Specified Deviation Pass Fail displayed. As Specified Deviation Pass Fail
icon displayed Sample Comment is
displayed.
11. Select Quick Settings Message screen appears
“You are about to edit …Are Test Completed by: Date:
you sure you want to As Specified Deviation Pass Fail
continue?” List any observed deviations or comments.

Test Completed by: Date:


List any observed deviations or comments.

Reviewed By: Date:


Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 179 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 180 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail Test Action Specified Actual Pass/Fail
22. Select OK; message View Buffered Data/Sample 32. Start a sample cycle by Count cycle begins after
screen disappears; in a Comment Mode pressing the RUN icon DELAY time expires; RUN
As Specified Deviation Pass Fail
few seconds the View screen is displayed displayed at top left; 3
As Specified Deviation Pass Fail sample runs completed
Buffered Data/Sample
Comment Mode screen 33. Examine display; Message screen titled
appears. message screen titled Sample Comment is
displayed. As Specified Deviation Pass Fail
23. Verify panel is colored Environmental panel is Sample Comment is
green; Sample Aborted! colored green; Sample displayed.
message is displayed Aborted! message is As Specified Deviation Pass Fail 34. Select OK; message View Buffered Data/Sample
displayed at bottom of
screen disappears and Comment Mode
Environmental panel
View Buffered screen is displayed As Specified Deviation Pass Fail
24. Select the icon on the The Enter Sample Comment Data/Sample Comment
bottom of the screen that screen is displayed Mode screen appears.
As Specified Deviation Pass Fail
looks like a yellow sheet Most recent sample is
35. Select “-“ button to go to
of paper displayed As Specified Deviation Pass Fail
most recent sample.
25. Select test message 1 Entry box at bottom of screen
displays test message 1 As Specified Deviation Pass Fail 36. Select the icon on the The Enter Sample Comment
bottom of the screen that screen is displayed
View Buffered Data/Sample As Specified Deviation Pass Fail
26. Select the Return (bent looks like a yellow sheet
arrow) icon Comment Mode As Specified Deviation Pass Fail of paper
screen is displayed
37. Touch area within text Keyboard entry screen titled
27. Select Return again A message box appears “Are entry box at bottom of Enter Sample Comment As Specified Deviation Pass Fail
you sure you wish to proceed screen displayed.
using Sample Comment: “test As Specified Deviation Pass Fail
message 1”? 38. Type Manual Entry Entry box at bottom of screen
Example; select Enter displays Manual Entry As Specified Deviation Pass Fail
28. Select Yes button Sample screen is displayed As Specified Deviation Pass Fail Example
key
29. Printout is generated with Printout is generated with 39. Select the Return (bent View Buffered Data/Sample
test message 1 printed. As Specified Deviation Pass Fail
test message 1 printed. arrow) icon Comment Mode screen is As Specified Deviation Pass Fail
30. Remove printout; mark as Printout removed and displayed
Sample Comments Test marked as Sample As Specified Deviation Pass Fail 40. Select Return again A message box appears “Are
1 Comments Test 1. you sure you wish to proceed
using Sample Comment: As Specified Deviation Pass Fail
31. Attach printout to this Printout attached to this “Manual Entry Example”?
As Specified Deviation Pass Fail
procedure. procedure
41. Select Yes button Sample screen is displayed As Specified Deviation Pass Fail
Test Completed by: Date:
Test Completed by: Date:
List any observed deviations or comments. List any observed deviations or comments.

Reviewed By: Date: Reviewed By: Date:

IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 181 of 223 IQ/OQ Protocol for MET ONE 3400 Series Particle Counters Page 182 of 223
Edition 6.5 Released June 2013 For proprietary use only. Edition 6.5 Released June 2013 For proprietary use only.
Test Action Specified Actual Pass/Fail 5.12 Option: Data Export
42. Printout is generated with Printout is generated with
Manual Entry Example Manual Entry Example As Specified Deviation Pass Fail Purpose:
printed. printed.
This section verifies that the operator can export acquired data in several formats, using USB memory
43. Remove printout; mark as Printout removed and drive, FTP via Ethernet connections, or both.
Sample Comments Test marked as Sample As Specified Deviation Pass Fail
2 Comments Test 2. 1. The possible data formats for USB are:
44. Attach printout to this Printout attached to this a) PDF
procedure As Specified Deviation Pass Fail
procedure.
b) CSV (comma separated variable)
45. Select Return to go to Counter Navigation
screen is displayed
c) TSV (Tab-separated variable)
Counter Navigation As Specified Deviation Pass Fail
screen. d) XML
46. Select the Printer icon. The Print Center screen is e) PortAll (HACH utility software)
displayed As Specified Deviation Pass Fail
2. The first four formats will be tested in this procedure. The PortAll format is unique to that
47. Select the Buffer icon. The Printing message is
As Specified Deviation Pass Fail software and, when PortAll software is used, the PortAll data format is tested as part of the
momentarily displayed
validation of PortAll software.
48. Printout is generated Printout is generated with As Specified Deviation Pass Fail
data headers Manual Entry 3. The possible data formats for FTP are limited to:
Example and test message a. PDF
1.
Note: If Export to Excel option is ENABLED on the PDF tab under System Settings, a .csv file will
49. Remove printout; mark as Printout removed and marked As Specified Deviation Pass Fail also be transmitted via FTP in addition to the PDF file. In this test, the option of Export to Excel will
Sample Comments Test as Sample Comments Test be disabled so the FTP transmission will only contain a PDF file.
3 3.
b. XML
50. Compare first two printout Data and comment fields
examples with buffer match As Specified Deviation Pass Fail 4. If the FTP option will not be used, mark Section 5.12.2 as “N/A”.
printout
51. Printout attached to this Printout attached to this Execution Materials, Documents, and Instruments:
As Specified Deviation Pass Fail
procedure. procedure 1. Met One 3400 series counter, configured by IS/IT for FTP transfer if required
Test Completed by: Date: 2. User Manual MET ONE 3400 Series
3. USB Flash Drive with at least 100 MB of available space. A memory drive that is empty is
List any observed deviations or comments.
preferred.
4. Computer with appropriate software to read and display these file types: PDF, .csv, .tsv, XML
5. Printer connected to computer, local or on network

Test Setup:

Note:
Reviewed By: Date: When there is a possibility to enable or disable a function on the particle counter, the
presence of a checkmark 9 within the adjacent box ; indicates that the function is
ENABLED; an empty box … indicates the function is DISABLED.

1. Verify that the power supply is properly set up and connected.


2. Verify that at least one battery is installed. The green light for Battery status (underneath the
Power ON/OFF button) may blink if the battery or batteries are not at full charge. The Battery

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status LED should be a steady green light when the installed battery or batteries are fully
5.12.1 Testing Option: Data Export, USB
charged. These tests can be conducted whether charging is in progress or completed.
3. Verify that the printer has a roll of paper installed with at least half a roll of unused paper remaining. Test Action Specified Actual Pass/Fail
4. Touch front panel POWER button to turn ON. Counter will boot-up to Counter Navigation screen. 1. Remove zero count filter if Zero count filter is not
As Specified Deviation Pass Fail
5. On the Counter Navigation screen, select the System icon. installed attached to the unit
6. On the Sounds tab, verify that each sound parameter is set to some value other than None and 2. On the Counter The System Settings screen
that the volume is set to an audible level. Navigation screen, select is displayed As Specified Deviation Pass Fail
the System icon
7. On the Basic tab, confirm that User Logon Required is ENABLED. User is logged onto Model
3. On the Options and The message screen
3400 as Administrator (“admin”). Accessories tab, select Clear Sample Buffer is As Specified Deviation Pass Fail
8. On the Basic tab, ENABLE the Confirm Sample Batch ID, Comments and Alarm Reasons the Clear Buffer button displayed
option. 4. Select Yes Clear Sample Buffer
screen disappears; Data As Specified Deviation Pass Fail
9. On the Custom tab, ENABLE the Store Partial Data option.
Buffer value is 0.
10. On the PDF tab, ENABLE PDF on USB detect option, then DISABLE the Export to Excel option, 5. Select the Sample Sample Comment screen
then DISABLE PDF on USB detect option. As Specified Deviation Pass Fail
Comments icon appears
11. On the Units and Alarms tab, select the Reasons (“bell”) icon. Using the drop-down menu at the 6. Select the arrow on the The drop-down box opens.
lower right corner, set the value to Disabled. drop-down box in the After Required selected,
As Specified Deviation Pass Fail
lower right corner; list closes and Required is
12. Using the Return (“bent arrow”) icon, return to the System Settings screen.
select Required displayed.
13. Using the Return again, return to the Counter Navigation screen.
7. Select the RETURN (bent The System Settings
14. Select the Print icon, verify or set the Sample Print Mode to All and Cycle Print Order to 10-1. As Specified Deviation Pass Fail
arrow) icon screen is displayed
15. Using the Return icon, return to the Counter Navigation screen. 8. Select Return again The Counter Navigation
As Specified Deviation Pass Fail
16. Remove any printouts from the printer. screen is displayed
9. Select the Sample The Sample screen is
As Specified Deviation Pass Fail
icon displayed
Test Method: Message screen appears
10. Select Quick Settings
“You are about to edit …Are
1. If only USB transfer mode will be employed, execute only the test scripts in section 5.12.1. Do not you sure you want to As Specified Deviation Pass Fail
execute Section 5.12.2; marked that section as “not applicable” (“n/a”) continue?”
2. IF FTP transfer will be used, execute Section 5.12.1 first, followed by Section 5.12.2 Message screen disappears;
11. Select Yes
SAMPLE SETUP screen As Specified Deviation Pass Fail
Acceptance Criteria: appears
1. Actual is equivalent to Specified. 12. Select the General tab The General tab screen is As Specified Deviation Pass Fail
2. Some file formats such as XML will contain additional information compared to printouts. In displayed
comparing the various output types, the acceptance criteria will be that the export format accurately Test Completed by: Date:
includes all data present on the printout; it will be acceptable if the file format includes information
List any observed deviations or comments.
above and beyond the printout.

Reviewed By: Date:

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Test Action Specified Actual Pass/Fail Test Action Specified Actual Pass/Fail
13. Set the values to Values set to 22. Verify panel is colored Environmental panel is
Count Cycles 1 Count Cycles 1 Count Cycles ____________ green; Sample Aborted! colored green; Sample
Run Mode Auto Run Mode Auto Run Mode ____________ Pass Fail message is displayed Aborted! message is As Specified Deviation Pass Fail
Count Display ____________ displayed at bottom of
Count Display Cumulative Count Display Cumulative
Environmental panel
Count Mode Counts Count Mode Counts Count Mode ______________
14. Select the Timing tab The TIMING tab screen is 23. Select the icon on the The Enter Sample Comment
As Specified Deviation Pass Fail bottom of the screen that screen is displayed
displayed As Specified Deviation Pass Fail
looks like a yellow sheet
15. Set the values to Values set to
of paper
Sample Time 00:00:10 Sample Time 00:00:10 Sample Time ____________
Pass Fail Keyboard entry screen titled
Hold Time 00:00:00 Hold Time 00:00:00 Hold Time ____________ 24. Touch area within text
Delay time ____________ entry box at bottom of Enter Sample Comment As Specified Deviation Pass Fail
Delay time 00:00:06 Delay time 00:00:06 displayed.
screen
16. Select the Return The Sample screen is
As Specified Deviation Pass Fail 25. Type Manual Entry 1; Entry box at bottom of screen
icon displayed
displays Manual Entry 1 As Specified Deviation Pass Fail
select Enter key
17. Start a sample cycle by Count cycle begins after
pressing the RUN icon DELAY time expires; RUN As Specified Deviation Pass Fail 26. Select the Return (bent View Buffered Data/Sample
displayed at top left arrow) icon Comment Mode screen is As Specified Deviation Pass Fail
displayed
18. After a few seconds, Count cycle stops; Stop
stop the sample cycle by displayed at top left As Specified Deviation Pass Fail 27. Select Return again A message box appears “Are
pressing the stop icon you sure you wish to proceed
using Sample Comment: As Specified Deviation Pass Fail
19. Examine printout; Message SAMPLE “Manual Entry1”?
message SAMPLE ABORTED printed at top of
As Specified Deviation Pass Fail 28. Select Yes button Sample screen is displayed As Specified Deviation Pass Fail
ABORTED printed at top printout
of printout 29. Printout is generated with Printout is generated with
Manual Entry 1 printed. As Specified Deviation Pass Fail
20. Examine display; Message screen titled Manual Entry 1 printed.
message screen titled Sample Comment is
displayed. As Specified Deviation Pass Fail 30. Remove printout; mark as Printout removed; marked as
Sample Comment is As Specified Deviation Pass Fail
Export Test 1 Export Test 1
displayed.
31. Attach printout to this Printout attached to this
21. Select OK; message View Buffered Data/Sample As Specified Deviation Pass Fail
procedure. procedure
screen disappears; in a Comment Mode
few seconds the View screen is displayed 32. Start a sample cycle by Count cycle begins after
As Specified Deviation Pass Fail
Buffered Data/Sample pressing the RUN icon DELAY time expires; RUN
As Specified Deviation Pass Fail
Comment Mode screen displayed at top left; one
appears. sample run completed
Test Completed by: Date: Test Completed by: Date:
List any observed deviations or comments.
List any observed deviations or comments.

Reviewed By: Date: Reviewed By: Date:

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Test Action Specified Actual Pass/Fail Test Action Specified Actual Pass/Fail
33. Examine display; Message screen titled 44. Select the Return (bent Counter Navigation
message screen titled Sample Comment is arrow) icon to go to screen is displayed As Specified Deviation Pass Fail
displayed. As Specified Deviation Pass Fail
Sample Comment is Counter Navigation
displayed.
45. Select the Printer icon. The Print Center screen is
displayed As Specified Deviation Pass Fail
34. Select OK; message View Buffered Data/Sample
screen disappears and Comment Mode The Printing message is
46. Select the Buffer icon. As Specified Deviation Pass Fail
View Buffered screen is displayed As Specified Deviation Pass Fail momentarily displayed
Data/Sample Comment
Mode screen appears. 47. Printout is generated Printout is generated with As Specified Deviation Pass Fail
data headers Manual Entry 1
35. Select the icon on the The Enter Sample Comment and Manual Entry 2
bottom of the screen that screen is displayed
As Specified Deviation Pass Fail 48. Remove printout; mark as Printout removed and marked As Specified Deviation Pass Fail
looks like a yellow sheet
of paper Export Test 3 as Export Test 3.

36. Touch area within text Keyboard entry screen titled 49. Compare first two printout Data and comment fields
entry box at bottom of Enter Sample Comment As Specified Deviation Pass Fail examples with buffer match As Specified Deviation Pass Fail
screen displayed. printout

37. Type Manual Entry 2; Entry box at bottom of screen 50. Printout attached to this Printout attached to this
As Specified Deviation Pass Fail As Specified Deviation Pass Fail
select Enter key displays Manual Entry 2 procedure. procedure

38. Select Return (bent View Buffered Data/Sample 51. Select the Return (bent Counter Navigation
arrow) icon Comment Mode screen is As Specified Deviation Pass Fail arrow) icon to go to screen is displayed As Specified Deviation Pass Fail
displayed Counter Navigation
39. Select Return again A message box appears “Are 52. Select the Export icon. The Export Sample Data
screen is displayed As Specified Deviation Pass Fail
you sure you wish to proceed
using Sample Comment: As Specified Deviation Pass Fail
“Manual Entry 2”? 53. Set Export to: USB Flash USB Flash Drive - Not
As Specified Deviation Pass Fail
Drive - Not Installed Installed is selected
40. Select Yes button Sample screen is displayed As Specified Deviation Pass Fail
54. From the list under File File Type is set to PDF As Specified Deviation Pass Fail
41. Printout is generated with Printout is generated with Type, select PDF
Manual Entry 2 printed. As Specified Deviation Pass Fail
Manual Entry 2 printed.
55. From the list under The phrase All Records
42. Remove printout; mark as Printout removed and Records to Export: appears in the box As Specified Deviation Pass Fail
marked as Export Test 2. As Specified Deviation Pass Fail
Export Test 2 select All Records
43. Attach printout to this Printout attached to this 56. Remove checkmark in Box next to Use PDF Page
As Specified Deviation Pass Fail box next to Use PDF and File Break Rules is
procedure. procedure As Specified Deviation Pass Fail
Page and File Break empty
Test Completed by: Date: Rules or leave empty
List any observed deviations or comments. Test Completed by: Date:
List any observed deviations or comments.

Reviewed By: Date:


Reviewed By: Date:

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Test Action Specified Actual Pass/Fail Test Action Specified Actual Pass/Fail
57. Touch the window under Entry screen marked Enter 68. Select the Export icon. The Export Sample Data
As Specified Deviation Pass Fail screen is displayed As Specified Deviation Pass Fail
File Name Export Filename appears
58. Use the letter keys to The phrase Export Test 69. From the list under File File Type is set to Excel As Specified Deviation Pass Fail
enter the title Export USB appears in the As Specified Deviation Pass Fail Type, select Excel (.tsv) (.tsv)
Test USB; press the window below File Name:
ENTER button 70. Touch the window under Entry screen marked Enter As Specified Deviation Pass Fail
File Name Export Filename appears
59. Install a USB Flash After a short interval, the red
Drive in the port on the lettering disappears and 71. Use the letter keys to The phrase Export Test
As Specified Deviation Pass Fail enter the title Export USB appears in the
front of the instrument USB Flash Drive - Installed As Specified Deviation Pass Fail
message is displayed Test USB; press the window below File Name:
ENTER button
60. Press the Export button File Export screen appears;
progress reporting with 72. Press the Export button File Export screen appears;
As Specified Deviation Pass Fail progress reporting with
entries: Building file; As Specified Deviation Pass Fail
Uploading file; Validating file; entries: Building file;
Uploading file; Validating file;
61. Export transfer Message box disappears
complete and Counter Navigation As Specified Deviation Pass Fail 73. Export transfer Message box disappears
complete and Counter Navigation As Specified Deviation Pass Fail
screen is displayed.
screen is displayed.
62. Select the Export icon. The Export Sample Data
screen is displayed As Specified Deviation Pass Fail 74. Select the Export icon. The Export Sample Data
screen is displayed As Specified Deviation Pass Fail
63. From the list under File File Type is set to Excel As Specified Deviation Pass Fail
Type, select Excel (.csv) (.csv) 75. From the list under File File Type is set to XML As Specified Deviation Pass Fail
Type, select XML
64. Touch the window under Entry screen marked Enter As Specified Deviation Pass Fail
File Name Export Filename appears 76. Touch the window under Entry screen marked Enter As Specified Deviation Pass Fail
File Name Export Filename appears
65. Use the letter keys to The phrase Export Test
USB appears in the 77. Use the letter keys to The phrase Export Test
enter the title Export As Specified Deviation Pass Fail
Test USB; press the window below File Name: enter the title Export USB appears in the As Specified Deviation Pass Fail
ENTER button Test USB; press the window below File Name:
ENTER button
66. Press the Export button File Export screen appears;
progress reporting with 78. Press the Export button File Export screen appears;
As Specified Deviation Pass Fail progress reporting with
entries: Building file; As Specified Deviation Pass Fail
Uploading file; Validating file; entries: Building file;
Uploading file; Validating file;
67. Export transfer Message box disappears
complete and Counter Navigation As Specified Deviation Pass Fail 79. Export transfer Message box disappears
complete and Counter Navigation As Specified Deviation Pass Fail
screen is displayed.
screen is displayed.
Test Completed by: Date:
Test Completed by: Date:
List any observed deviations or comments. List any observed deviations or comments.

Reviewed By: Date:


Reviewed By: Date:

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Test Action Specified Actual Pass/Fail Test Action Specified Actual Pass/Fail
80. Remove USB drive USB drive is mounted on 91. Compare data on All of the data on Export
from particle computer and list of files file printout with Test 3 is present and is
counter; install on can be observed on As Specified Deviation Pass Fail data on printout accurate on file printout As Specified Deviation Pass Fail
computer; verify computer screen marked Export
access to files Test 3
81. Verify PDF file on PDF file type named Export As Specified Deviation Pass Fail 92. Mark file printout Printed output is marked
USB Drive Test USB is observed as Export Test 6; and saved As Specified Deviation Pass Fail
save with test
82. Print file in Printed version of file is As Specified Deviation Pass Fail
readable form available 93. Verify XML file on XML file type named
USB Drive Export Test USB is As Specified Deviation Pass Fail
83. Compare data on All of the data on Export observed
file printout with Test 3 is present and is
data on printout accurate on file printout 94. Print file in Printed version of file is As Specified Deviation Pass Fail
marked Export As Specified Deviation Pass Fail readable form available
Note: Sample Comment may be
Test 3 printed after data on Export PDF
instead of above as on particle 95. Compare data on All of the data on Export
counter printer output file printout with Test 3 is present and is
data on printout accurate on file printout As Specified Deviation Pass Fail
84. Mark file printout Printed output is marked
As Specified Deviation Pass Fail marked Export
as Export Test 4; and saved
Test 3
save with test
96. Mark file printout Printed output is marked
85. Verify .csv file on .csv file type named Export As Specified Deviation Pass Fail As Specified Deviation Pass Fail
as Export Test 7; and saved
USB Drive Test USB is observed
save with test
86. Print file in Printed version of file is As Specified Deviation Pass Fail Test Completed by: Date:
readable form available
List any observed deviations or comments.
87. Compare data on All of the data on Export
file printout with Test 3 is present and is
data on printout accurate on file printout As Specified Deviation Pass Fail
marked Export
Test 3
88. Mark file printout Printed output is marked
as Export Test 5; and saved As Specified Deviation Pass Fail
save with test Reviewed By: Date:
89. Verify.tsv file on .tsv file type named Export As Specified Deviation Pass Fail
USB Drive Test USB is observed
90. Print file in Printed version of file is As Specified Deviation Pass Fail
readable form available
Test Completed by: Date:
List any observed deviations or comments.

Reviewed By: Date:

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Test Action Specified Actual Pass/Fail
5.12.2 Testing Option: Data Export, FTP
7. Use the letter keys to The phrase Export Test
enter the title Export FTP appears in the As Specified Deviation Pass Fail
Test FTP; press the window below File Name:
ENTER button
Note:
8. Press the Configure FTP FTP Setup screen appears As Specified Deviation Pass Fail
This portion of the test requires that the particle counter be connected directly by Ethernet wiring or by 802.11 b/g button
wireless connection to your company’s network. The network connection will generally require the participation of 9. Press the Test FTP Test Connection
your company’s IT/IS department to provide critical parameters such as IP address, passwords, etc. Please do Connection button screen appears; multiple
not proceed with this test unless the particle counter is already connected to the network and the FTP connectivity text lines should appear, As Specified Deviation Pass Fail
Note: If this step fails, STOP test
has been proven. For additional information on the FTP connection requirements, please consult the user and consult with IS/IT group to ending with “Test
manual or other technical support. resolve connection issues. Connection Succeeded”
The previous test section, 5.12.1, must be completed previous to executing this test; this test depends upon the 10. Press the Return arrow FTP Setup screen appears As Specified Deviation Pass Fail
test data generated in the previous section in order to prove this function.
11. Press Return again The Export Sample Data As Specified Deviation Pass Fail
screen is displayed
12. Select the Export button File Export screen appears;
progress reporting with
Test Action Specified Actual Pass/Fail entries: Building file; As Specified Deviation Pass Fail

1. On the Counter The Export Sample Data Uploading file; Validating file;
Navigation screen, select screen is displayed As Specified Deviation Pass Fail
13. Export transfer Message box disappears
the Export icon. complete and Counter Navigation As Specified Deviation Pass Fail
2. Set Export to: Network screen is displayed.
Network Server is selected As Specified Deviation Pass Fail
Server 14. On the Counter The Export Sample Data
Navigation screen, select screen is displayed As Specified Deviation Pass Fail
3. From the list under File File Type is set to PDF As Specified Deviation Pass Fail
Type, select PDF the Export icon.

4. From the list under The phrase All Records 15. From the list under File File Type is set to XML As Specified Deviation Pass Fail
Records to Export: appears in the box As Specified Deviation Pass Fail Type, select XML
select All Records 16. From the list under The phrase All Records
5. Remove checkmark in Box next to Use PDF Page Records to Export: appears in the box As Specified Deviation Pass Fail
box next to Use PDF and File Break Rules is select All Records
empty As Specified Deviation Pass Fail
Page and File Break 17. Remove checkmark in Box next to Use PDF Page
Rules or leave empty box next to Use PDF and File Break Rules is
empty As Specified Deviation Pass Fail
6. Touch the window under Entry screen marked Enter Page and File Break
As Specified Deviation Pass Fail Rules or leave empty
File Name Export Filename appears
Test Completed by: Date: Test Completed by: Date:

List any observed deviations or comments. List any observed deviations or comments.

Reviewed By: Date: Reviewed By: Date:

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Test Action Specified Actual Pass/Fail Test Action Specified Actual Pass/Fail
18. Touch the window under Entry screen marked Enter As Specified Deviation Pass Fail 28. Compare data on All of the data on Export
File Name Export Filename appears file printout with Test 3 is present and is
data on printout accurate on file printout As Specified Deviation Pass Fail
19. Use the letter keys to The phrase Export Test
marked Export
enter the title Export FTP appears in the As Specified Deviation Pass Fail Test 3
Test FTP; press the window below File Name:
ENTER button 29. Compare data on All of the data on Export
20. Select the Export button File Export screen appears; file printout with Test 3 is present and is
progress reporting with data on printout accurate on file printout As Specified Deviation Pass Fail
entries: Building file; As Specified Deviation Pass Fail marked Export
Uploading file; Validating file; Test 3

21. Export transfer Message box disappears 30. Mark file printout Printed output is marked
complete and Counter Navigation As Specified Deviation Pass Fail as Export Test 9; and saved As Specified Deviation Pass Fail
screen is displayed. save with test

22. Verify PDF file on PDF file type named Export Test Completed by: Date:
As Specified Deviation Pass Fail
network Drive Test FTP is observed List any observed deviations or comments.
23. Print file in Printed version of file is As Specified Deviation Pass Fail
readable form available
24. Compare data on All of the data on Export
file printout with Test 3 is present and is
data on printout accurate on file printout As Specified Deviation Pass Fail
marked Export
Test 3 Reviewed By: Date:
25. Mark file printout Printed output is marked
as Export Test 8; and saved As Specified Deviation Pass Fail
save with test
26. Verify XML file on XML file type named
network Drive Export Test FTP is As Specified Deviation Pass Fail
observed
27. Print file in Printed version of file is As Specified Deviation Pass Fail
readable form available
Test Completed by: Date:
List any observed deviations or comments.

Reviewed By: Date:

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6 Discrepancies 7 Approval of Completed Protocol

Discrepancy Protocol
Protocol
Date of Date Signatures ensure that all test scripts in this Installation / Operational Qualification met the
page Initial Date Acceptance Criteria and all discrepancies have been resolved with appropriate corrective
number section occurrence approved
number
action.

Name Department/Role Signature Date Verified

List any observed deviations or comments.

Reviewed By: Date:

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8 References 9 Appendices

1. User Manual MET ONE 3400 Series, Edition 5 Appendix Description Protocol Section Reference
2. ISO 14644-1:1999
3. EU GMP Annex 1:2008 Appendix A: System Documentation Verification ..............................................3.1
4. FS 209E Appendix E [obsolete]
5. BS 5295 [obsolete] Appendix B: Utilities Verification .......................................................................3.2

Appendix C: Hardware Description/Identification ..............................................3.3

Appendix D: Software Description/Identification................................................3.4

Appendix E: Calibration Verification ..................................................................3.5

Appendix F: Preventive Maintenance Procedures ............................................3.6

Appendix G Recommended Spare Parts..........................................................3.7

Appendix H Operator Interface Verification ......................................................4.1

Appendix I System Security ...........................................................................4.2

Appendix J Group Settings ..............................................................................4.3

Appendix K Operating Modes ..........................................................................4.4

Appendix L Test Wizard Verification ................................................................4.5

Appendix M USB Data Download Verification ..................................................4.6

Appendix N Alarm Testing................................................................................4.7

Appendix O Power Failure and Recovery Testing ............................................4.8

Appendix P Tests for Certain Options .................................................................5

Appendix Q Informative: SD and SE Calculations

Appendix R Informative: Null Modem Wiring

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Appendix A:
Appendix B:
Protocol Section 3.1
Protocol Section 3.2
System Documentation Verification
Utilities Verification
Total number of packets in this appendix: ____
Total number of packets in this appendix: ____

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Appendix C: Appendix D:

Protocol Section 3.3 Protocol Section 0

Hardware Description/Identification Software Description/Identification

Total number of packets in this appendix: ____ Total number of packets in this appendix: ____

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Appendix E: Appendix F:

Protocol Section 3.5 Protocol Section 3.6

Calibration Verification Preventive Maintenance Procedures

Total number of packets in this appendix: ____ Total number of packets in this appendix: ____

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Appendix G: Appendix H:

Protocol Section 3.7 Protocol Section 4.1

Recommended Spare Parts Operator Interface Verification

Total number of packets in this appendix: ____ Total number of packets in this appendix: ____

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Appendix I: Appendix J:

Protocol Section 4.2 Protocol Section 4.3

System Security Group Settings

Total number of packets in this appendix: ____ Total number of packets in this appendix: ____

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Appendix K: Appendix L:

Protocol Section 4.4 Protocol Section 4.5

Operating Modes Test Wizard Verification

Total number of packets in this appendix: ____ Total number of packets in this appendix: ____

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Appendix M: Appendix N:

Protocol Section 4.6 Protocol Section 4.7

USB Data Download Verification Alarm Testing

Total number of packets in this appendix: ____ Total number of packets in this appendix: ____

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Appendix O: Appendix P:

Protocol Section 4.8 Protocol Section 5

Power Failure and Recovery Testing Tests for Certain Options

Total number of packets in this appendix: ____ Total number of packets in this appendix: ____

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1. Calculation of Standard Deviation (SD)
In Sections 4.5.2 and 4.5.3 covering ISO 14644-1 and Section 5.5.2 Federal Standard 209E
Report Verification, reference is made to calculation of a Standard Deviation (SD). Examples
of this calculation are given in ISO 14644-1, Annex C and FS 209E, 5.4.2 and Appendix E. A
brief explanation of this calculation is given; users should refer to the appropriate standard for
additional details.
Standard deviation is a measurement of the variability of repeated measurements of a
parameter, in this case, particle counts. The ideal cleanroom or zone would have similar count
values in all areas of that room or zone. The real cleanroom or zone will have some variability
and SD is an indicator of that variability.
The SD measurement is a comparison of the average count value for each sampled location
Appendix Q (A1, A2, A3, A4,...) with the Mean of the Averages (M). The SD is determined by the following
formula, where L is the number of locations sampled, Ax is the average of the samples taken at
Informative – SD and SE Calculations Location x, and M is the Mean of Averages.

(A1-M)2 + (A2-M)2 + (A3-M)2 + (A4-M)2 ,...


SD =
L-1

2. Calculation of Standard Error (SE)


In Sections 4.5.2 and 4.5.3 covering ISO 14644-1 and Section 5.5.2 Federal Standard 209E
Report Verification, reference is made to calculation of a Standard Error (SE). Examples of
this calculation are given in ISO 14644-1, Annex C and FS 209E, 5.4.2 and Appendix E. A
brief explanation of this calculation is given; users should refer to the appropriate standard for
additional details.
The SE represents the variability of the data with an additional adjustment based on the
number of locations (L) sampled.
SE = SD
¥L

where SD is the Standard Deviation previously calculated and L is the number of sample
Locations used in this classification effort.

3. Calculation of the 95 % Upper Confidence Limit (UCL)


An added calculation is required by these standards to compensate for a sampling plan in
which only a few sampling locations are used to profile an area. In effect, the 95% UCL is a
“statistician’s penalty” to create a high level of assurance that the classification obtained when
only a few sample points are used is statistically sound enough to represent the true character
of the room in terms of airborne particle counts. There are two slight differences between the
ISO standard and the Federal Standard in the calculation of the UCL so the results of both
methods can differ slightly, but not usually enough to change the major classification of an
area.

The basic calculation for the 95% UCL is given by


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UCL = M + (SE*t0.95)

Where t0.95 is the Student’s t factor value for the number of sampling positions used in the
classification method, M is the Mean of the Averages of the sample count data and SE is the
Standard Error calculated below. The formula above shows that the “statistician’s penalty”
creates an additive term that increases for larger values of Standard Error and also increases
when fewer number of sampling points are used, as dictated by the tables below for the
Student’s t factor (t0.95).

Difference 1: Number of sample points that trigger the use of the UCL
For the Federal Standard 209E, the UCL is used for a sampling method in which there are
between 2 [minimum number of points required by FS209E] and 9 sampling points. For
sampling methods in which there are 10 or more sampling points, the UCL does not need to be Appendix R
calculated; the classification is based only on the mean of the averages of the count data from
each position. Informative – Null Modem Wiring
For the ISO 14644-1 standard, a single position is acceptable for cleanrooms or zones with an
area equal to or less than one square meter. When only one sampling point is used to classify
the clean area, the result is determined by the average of three or more samples at that point
[see ISO 14644-1, Annex B.4.3.4].
The calculation of the UCL is required for any sampling method in which there are at least 2
but less than 10 positions used to categorize the cleanroom or zone.

Difference 2: Values of Student’s t factor used for 95% UCL calculation


There is a very minor variation in the Student’s t factor values used in Federal Standard 209E
and in ISO 14644-1. In almost all cases, this difference in values will not change the
classifications obtained using one method or the other.

Student’s t factor for Federal Standard 209E and ISO 14644-1


Number of
sample 10 or
positions > 1 2 3 4 5 6 7 8 9 more

FS 209E n/a 6.31 2.92 2.35 2.13 2.02 1.94 1.90 1.86 n/a

ISO 14644-1 n/a 6.3 2.9 2.4 2.1 2.0 1.9 1.9 1.9 n/a

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Appendix R: Null modem wiring (Informative)

Type 1

DB 9 pins Type 1
1 4
2 3
3 2
4 6,1
5 5
6 4
7 8
8 7
9 no connection

Type 2

DB 9 pins Type 2
1 4
2 3
3 2
4 1
5 5
6 no connection
7 8
8 7
9 no connection

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Edition 6.5 Released June 2013 For proprietary use only.

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