Attachment 1 Requirements Traceability Matrix.pdf
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- Request for Information-Radioisotope Detection & Identification Devices (RIIDs) Federal contract opportunity
- Solicitation number
- 70RWMD20RFI00000001
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| File | Type | Posted |
|---|---|---|
| RIIDs Q&A.pdf | ||
| STC RIIDs RFI (Amended).pdf | ||
| Attachment 2 - NDA Template.docx | DOCX document | |
| STC RIIDs RFI.pdf |
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Request for Information # 70RWMD20RFI00000001 Attachment 1-STC RIID Minimum Requirements Traceability Matrix
Table 1: STC RIID Minimum Requirements Traceability Matrix
Requirement # Description Threshold Objective Clarification
SL-01 The RIID shall be a portable, battery powered instrument for field use.
The RIID shall not require any external devices or power supplies (e.g., laptop personal computer, mobile device) for the detection, identification and display of the presence of radioactive material.
Objective=Threshold None
SL-02 The RIID shall be hand held and easily distinguishable from a Personal Radiation Detector or Spectroscopic Personal Radiation Detector, for rapid field responses.
The RIID shall have a mass of less than 3.3 pounds.
Objective=Threshold This mass shall include the batteries and any kind of protective rubber bumper or sleeve for the RIID, but not an external carrying case.
SL-03 The RIID shall have a form factor which enables it to be used and secured with one hand.
The RIID shall have a handle which can be easily gripped with one hand and secured with a detachable wrist lanyard.
Objective=Threshold The wrist lanyard shall be adjustable or large enough to be worn if an operator is wearing a hazardous materials technician style glove.
SL-04 The RIID shall be wearable in holster.
The RIID shall be comfortably wearable in a holster to be clipped on the waist or strapped around an arm or leg of an operator. The purpose of the holster is to transport the RIID.
Objective=Threshold
The RIID is not intended to be used while in the holster.
Dimensions of the RIID shall be less than 4” x 11” x 5 “.
SL-05 The RIID shall be constructed to endure the rigors of daily field use by first responders.
The body of the RIID shall be made of a ruggedized material (such as metal) designed to be used in first responder environments and built as one factory sealed enclosure, with no user serviceable/interchangeable parts or pieces accessible to the user.
Objective=Threshold The housing must be constructed as one factory sealed enclosure. It is acceptable to have a battery compartment door or handle which is removable from the body of the RIID.
It is not acceptable to offer a modular solution using a more lightweight RIID, e.g. a handle “housing” or grip option which can be attached/unattached by the operator or a technician, to smaller RIID.
SL-06 The RIID shall have its own display.
The RIID shall have a display face which is a permanent part of the housing.
Objective=Threshold The RIID must have the display on the body of the RIID which is independent of any mobile phone or tablet it may connect to.
SL-07 The RIID display shall be visible in low and bright light conditions.
The display and external control functions shall be visible and fully usable in low light (<150 lx) and bright light (>10 000 lx) conditions. The bright light condition requirements includes having the RIID display being fully visible while an operator is wearing polarized sunglasses.
SL-08 The RIID shall have more than one option for batteries used.
The RIID shall use rechargeable and/or alkaline batteries.
Objective=Threshold
SL-09 The RIID shall have Environmental Protection from dust.
The RIID shall be in compliance with IP53.
The RIID shall be in compliance with IP67.
SL-10 The RIID shall have a way to function on battery power for 5 hours or more.
The requirements for battery power are as follows:
a) RIIDs shall have the ability to operate for a minimum of 5 hours of continuous use (non-alarm state) in standard test conditions (see Table 1 of ANSI N42.34- 2015).
b) The manufacturer shall state the expected continuous operating time using the recommended batteries at standard test temperature conditions and at −20 °C. The batteries selected should enable the RIID to operate for at least 1 h at −20 °C.
c) RIIDs shall have a low-battery indication.
d) Non-rechargeable batteries shall be widely available, shall not
The RIID shall have the ability to operate for a minimum of 8 hours of continuous use, in standard test conditions.
IAW ANSI N42.34-2015,
Section 5.11.1
Standard operating conditions here is assumed to IAW Table 1 of ANSI N42.34-2015).
Bluetooth (if available) shall be activated for occasional transfer of static, saved files.
The RIID shall operate in the default mode (often called a Dose Rate or measurement mode) with periodic use of a search mode.
If the RIID can use more than one type of battery, it is necessary for only one of those types of batteries to power the RIID for 8 hours or more.
be unique to the RIID, and shall be field replaceable (e.g., AA, 9 V) without the use of special tools.
e) Battery chargers for rechargeable batteries shall meet applicable US electrical standards.
f) RIIDs should be capable of operating from an external dc source (e.g., 12 V vehicle electrical system, battery pack, ac converter).
g) It should be possible to switch batteries without having to shut down the RIID (not swappable)
The RIID batteries shall be hot swappable, meaning that the batteries shall be replaceable while the RIID is turned ON, such that the insertion of new batteries does not force the RIID to power OFF and perform a cold start, with re calibration and test screens.
SL-11 The RIID shall have an operationally acceptable warm up time.
The RIID shall have a warm up time of 3 minutes or less.
Objective=Threshold Tested IAW ANSI N42.34-2015, Section 5.10.1
SL-12 The RIID shall provide the necessary visual indicators.
The RIID shall provide visual indicators, when required, as referenced in ANSI N42.34-2015.
Objective=Threshold IAW ANSI N42.34-2015, Section 5.7.1
SL-13 The RIID shall detect gamma rays over a relevant range of energies.
25 keV – 3000 keV Objective = Threshold None
SL-14 The RIID shall measure gamma radiation Dose over a wide range.
1 uR/h – 100 R/h
Objective = Threshold None
SL-15 The RIID shall measure gamma radiation Dose Rate over a wide range.
0 nrem/h – 1.0 rem/h 1 uR/h – 1.0 R/h
Objective=Threshold This dose rate range may be achieved by using more than one gamma detector in the RIID (e.g. NaI scintillation detector for identification and Geiger-Mueller detector for high range Dose Rate and Dose).
SL-16 The RIID shall have an Overload Dose Rate of 100 rem/h or greater with one or more unique indications when this occurs.
The RIID shall display a unique overload Dose Rate indication (audible, visible or both) at 100 rem/h or greater.
Objective=Threshold None
SL-17 The detector in the RIID which is used for spectral identification of gamma radiation, shall have a medium resolution as defined here.
The detector used for identification shall have a resolution of less than or equal to 8% and greater than 6.5%, as measured at 662 keV.
Objective=Threshold The RIID shall have the resolution stated here, in keeping with its functional use for this deployment.
Lower resolution offerings shall not be considered. Operators will obtain further assistance from more specialized teams, if lower resolution RIID data are required.
SL-18 The RIID shall detect the presence of neutron radiation.
The RIID shall detect the presence of thermal neutrons with a sensitivity of not less than
2.6 cps/nv; ±20%
Objective=Threshold This requirement is verified using a 20 000 (±20%) neutrons/s 252Cf source.
SL-19 The RIID shall detect Neutrons in the presence of photons.
The neutron detector shall be insensitive to a 10 mR/h 137Cs photon radiation field. In addition, the RIID shall be able to detect an increase in neutron radiation while being exposed to the photon radiation field.
Objective=Threshold This requirement is verified using a 20 000 (±20%) neutrons/s 252Cf source (ANSI N42-34-2015,Table 4) surrounded by a 4-cm thick high density polyethylene (HDPE) with the 252Cf source placed at the center of the moderator center of the moderator and the center of the moderator placed at a distance of 25 cm from the reference point of the RIID. For this test, the alarm or indication shall activate no later than 1 s after the RIID passes through the test point (point of closest approach) or the test point moves past the RIID.
Testing shall be performed in a location where neutron scatter is kept to a minimum. The source assembly, movement device (i.e., track), and the RIID shall be at least 1 m from any item or surface (e.g., storage cabinets, floor, ground surface). One meter was determined to be sufficient to keep scatter to a minimum for this source configuration.
SL-20 The RIID shall have a personal protection alarm which can be set.
An alarm shall be provided to alert the user that the ambient radiation intensity is above a
Objective=Threshold IAW ANSI N42.34-2015 user-selected threshold level (typically 2 mRem/h).
SL-21 The RIID shall have a specialized “search” mode.
• This “search” mode shall be easily accessible from the home screen of Easy User or Basic Mode the RIID (e.g.
one button push to activate it).
• This mode shall have a real time display that shows time (horizontal axis) vs. counts detected (vertical axis).
• This “search” mode must have an accompanying audible tone which varies as the intensity of the radiation does at the center of the centroid of the RIID.
• The operator shall have the ability to turn this tone ON/OFF through the user interface on the RIID, when in Easy or Routine user mode.
• The current gamma dose rate and neutron count rate (in counts per second) shall be visible on the display screen at all times when using this “search” mode.
Objective=Threshold The display can show a vertically changing line or bars. It is not acceptable to use an alternate graphic representational style to visualize the fluctuating radiation levels (e.g. concentric rings, renderings of targets, objects or persons, etc.)
• All (gamma and neutron, over range) alarms must be visible and audible when using this “search” mode.
SL-22 The RIID shall identify gamma radiation sources.
The RIID shall meet or exceed the identification performance standards as stated in IAW ANSI N42.34-2015.
Objective=Threshold
SL-23 The RIID shall display a way to indicate the certainty of an identification result.
The identification results shown on the RIID shall indicate the certainty of the identification result using one of the following methods:
• An integer from 1-10
• A percentage (0-100%)
• A score of “Low”, “Medium” or “High” as long as the documentation clearly articulates the meaning of each term
Objective=Threshold
SL-24 The RIID shall allow the operator to collect and save a background spectrum, collected in an area free of any known radioactive material.
The RIID shall be able to save a “clean” background spectrum.
• The RIID shall display a text message which indicates that there are no gamma radiation sources detected, such as “Counts too low” or “No nuclide found” (or similar)
• When this text message is generated, the RIID shall
• After saving a clean background spectrum, the operators shall have the ability to tag the spectrum as “background” by selecting from a dropdown list or allow the operator to continue saving the spectrum.
• The spectrum shall be given a name which is in keeping with the naming convention of the RIID (time, date) manually naming the spectrum.
• The spectrum name shall include text to indicate that the spectrum is of a clean background. (e.g.
“bkg”, “background” or similar)
SL-25 The RIID shall have at least two different access modes.
RIIDs shall have at least two different access modes as follows:
a) Easy Mode: A mode that enables the user to perform detection and identification of radionuclides, measure exposure or ambient dose equivalent rate, save spectral files and if applicable, detect the presence of neutrons. Routine mode may also be called “simple” or “automatic” or “easy” mode.
b) Advanced Mode: A mode that enables an expert user (i.e., via password) to control parameters that can affect the result of a measurement (e.g., radionuclide library, routine function control, calibration parameters, alarm
Objective=Threshold IAW ANSI N42.34 Section 5.3.1 and STC Requirements The ANSI standard refers to one mode as “Routine or Easy Mode”.
For the sake of simplicity, this mode will be referred to only as “Easy Mode” in this document.
The other mode is “Restricted/Expert or Advanced”. This shall be referred to as “Advanced Mode” in this document.
thresholds). Restricted mode may also be called the “advanced” or “expert” mode. Advanced-mode functions may be performed by connecting the RIID to a computer.
Any other available access modes should be described (e.g., maintenance mode).
SL-26 The RIID shall have an Easy Mode.
The vendor shall provide the menu directory for Easy Mode with the response to this RFI.
Easy Mode of the RIID shall allow the operator to do the following:
• Power the RIID OFF
• View current gamma dose rate and neutron count rate at all times
• View the current date, time and battery status
• Access the Search Mode, Identification Mode and Advanced or Other Menus, with one button push
• Return to the Home screen from Search Mode, Identification Mode or Advanced or Other Menu screens with one button push
• Adjust the date, time and time zone
• Perform a functional field check/calibration with a small, unlicensed gamma radiation source
Objective=Threshold Additional details about required download settings are provided in the Data Transfer requirements of this document.
• Select a method to transfer to use to transfer saved files from the RIID to an approved mobile phone/tablet or PC/laptop.
• Adjust the time of the sample to be collected o The time range should be from 0-300 seconds at a minimum, for sample collection times
• Collect and save:
o A clean
“background” spectrum o A “known” spectrum o An “unknown” spectrum
• Choose from a drop down or radio button list to name each spectrum as one of the following:
o “Background” o “Known” o “Unknown”
• Adjust download file options o Operator shall be able to select “.zip” file for any files on the RIID (spectral files, images and voice messages if available)
SL-27 The RIID shall have download file options accessible to the operator while using Easy Mode.
The RIID (while in Easy Mode) shall allow the operator to select:
• file type for download (e.g.
N42, .zip or .pdf)
• download various spectral and report files as one bulk compressed file or as individual files and
• the date of collected files to download.
The name for this file(s) shall follow the pre-established naming convention used by the RIID, which is some variation of a time/date stamp.
Objective=Threshold For example, if an operator needs to quickly download all the files saved on the current date, the operator shall be able to access the download file options from the home screen of Easy/Routine mode (one button push) and select:
• Download files collected by today’s date
• Download as one .zip file
• Download as individual .zip files
SL-28 The RIID shall have an Advanced Mode.
The Advanced Mode shall be a mode that enables an expert user (i.e., via password) to control parameters that can affect the result of a measurement (e.g., editing of the radionuclide library, routine function control, calibration parameters, alarm thresholds). Advanced-Mode functions may be performed by connecting the RIID to a computer or Android OS device as described in this specification.
Any other available access modes should be described (e.g., maintenance mode).
Objective=Threshold
SL-29 The RIID shall have certain markings.
The RIID shall follow the general requirements for markings IAW ANSI N42.34-2015, Section 5.4.1 as well as providing the following markings on the RIID when the
Section 5.4.1 and STC requirement
RIID uses a web based interface as one method of connecting to and configuring the RIID:
1) IP address to use for access to web based interface via a USB connection to a PC or mobile device, if there is such an interface available
2) IP address to use to access web based interface via WiFi, if it is different than what is used for USB connectivity
SL-30 The RIID shall provide methods to transfer saved files to acceptable interfaces, as specified.
The RIID shall provide the operator with at least two methods of transferring files from the RIID to an approved mobile device or PC/laptop. One method shall be using a cable and the other method shall be using a media stick or one of the wireless methods listed below.
The acceptable methods are:
• USB cable to Android phone/tablet (OS 8.0 or later) and Windows OS computer (Windows 10.0 or later)
• USB stick/drive or media card
• Bluetooth 4.0 or later (Bluetooth tethering is not an allowable a
The RIID shall provide the operator with three or four of the methods described in the Threshold requirement of SL-30.
If additional data transfer methods are available on the RIID, they shall be deleted from all user interface menus, web interface menus and these features should be suppressed at the factory so as to ensure that they cannot be enabled in the field.
For example, if a RIID has been designed to allow an operator or local administrator to configure the RIID to use a mobile phone as a hotspot, in conjunction with a server (vendor provided or user configurable) to send RIID data directly from the RIID to a server or website, this feature shall not be visible and/or deleted from all accessible RIID menus – on the RIID and via any other web or application interface.
communications method.
It shall be disabled on the
RIID.)
• Secure WIFI
When using wireless data transfer techniques, the data shall be able to be encrypted, to FIPS level security or better.
The vendor shall provide a detailed description of the Bluetooth protocols used, to include but not limited to: the level of security, method of pairing and type of encryption used.
SL-31 The RIID shall be able to function as an external (mass)storage drive to allow files transfer from the RIID to an approved laptop or Android device.
The user shall be able to enable the RIID to function as a mass storage drive, while in Easy Mode so that files can be transferred to a mobile device or laptop without the use of any vendor proprietary software or web interfaces
Objective=Threshold This function shall be accessible in the Easy Mode.
The file transfer is one directional:
from the RIID to a laptop or mobile device.
The “RIID kit” should include any adapter cables, SD card and/or USB stick, which may be required to interface with an Android phone or tablet (OS 8.0 or later).
SL-32 If the RIID uses Bluetooth, then the vendor shall provide the Bluetooth communications protocols to ensure that
If the RIID uses Bluetooth, it shall be at least level II, to ensure FIPS compliance. The vendor shall provide the Bluetooth communications protocols to ensure this.
The RIID shall use Bluetooth communications protocol of level III or
IV.
If there are other available applications which allow a system or server to talk to the RIID, e.g. control the RIID remotely, the vendor must provide documentation and verification of how this feature would be securely disabled at the factory.
these transmissions can be encrypted.
SL-33 The RIID shall have a method for an administrator to configure operational parameters.
The RIID shall have be fully configurable (change alarm thresholds, edit identification settings, download saved files, etc.) via an Android tablet or phone (OS 8.0 or later) and laptop/PC (Windows 10 or later).
The configuration parameters shall be saved as a parameter file which can be used to quickly configure RIIDs by loading one set up file. (instead of individually configuring each feature)
The use of Bluetooth shall be for transmitting data from the RIID, only.
Bluetooth shall not be used for sending data to the RIID for configuring the RIID via mobile application or any other method.
SL-34 The RIID shall have well documented communications protocols which can be individually disabled from the factory, if they are deemed insufficiently secure.
If the RIID has additional ports and communication options not listed in this document, they shall listed in the response from the vendor and shown that they can be factory disabled.
Objective=Threshold This could include additional communications ports on the RIID and unapproved mobile applications.
SL-35 The RIID shall not transmit real time or near real time data.
The RIID shall not transfer real time or near real time data of any type – spectral or measurement values. Any existing configuration menus on the RIID shall be deleted or not visible/accessible, if they currently exist.
Objective=Threshold If the RIID has the ability to use a commercial cellular SIM card, this feature shall be factory disabled, to prevent its unauthorized use in the field.
If the RIID has Bluetooth, this shall be for the purpose of transmitting saved, static files on the RIID to an approved device.
SL-36 The RIID shall be configured to transfer files per the STC Program requirements, as stated in this RFI.
If the RIID user interface, mobile application or webserver, has menus/configurations which allow the operator to automatically upload, post or share saved files of any type (spectral, voice messages, screen shots, imagery) to any server, application or website not specified in this document, these features shall be deleted, factory suppressed and/or disabled from the RIID and all its interfaces.
Objective=Threshold The RIID shall not be able to export files to any system, service or application, not fully specified in this requirements document.
This includes the use of any special “Reachback” modes or data collection process designed by the vendor. Any such modes should be deleted or suppressed from RIID and interface menus.
All Reachback shall be conducted in accordance with National and local protocols. Data collection and storage methods shall be in accordance with the requirements, as stated in this document.
SL-37 The RIID shall have certain functions available on through the Advanced Mode.
The following information and control shall be provided for the restricted access user through access controls or special commands that are described in the manufacturer provided technical manual:
a) Access to and control of operating parameters (e.g., radionuclide library, integration time)
b) Access to and control of data logging process
c) Access to status indication criteria including the ability to set the exposure rate for activation of the radiation protection alarm
d) Access to energy and/or efficiency calibration information
Section 5.8.1
SL-38 The RIID shall have other indicators as required.
The RIID shall have the following indicators IAW ANSI N42.34- 2015:
• RIIDs shall provide an audible alarm to alert an operator to different types of conditions (e.g., detection of gamma radiation, detection of neutron radiation, battery low, and fault detection).
• Different techniques shall be used by the RIID to differentiate between each type of event that caused an audible alarm.
• The description shall be provided in the manual.
• The frequency of an audible alarm shall be from 1000 Hz to at least 4000 Hz. Where an intermittent alarm signal is provided, the interval shall not exceed 2 s. The A-weighted volume at a distance of 30 cm from the RIID shall be at least 80 dB(A) and shall not exceed 100 dB(A).
• It shall not be possible to disable both the vibration and audible alarm indications simultaneously, except through the restricted mode.
When both alarm signals are off, an indication shall be provided on the display
Objective=Threshold IAW ANSI N42.34-2015, Section 5.9.1 and STC Requirements
The earphone connection may be a physical connection or via Bluetooth connectivity.
to inform the user of this condition.
• An earphone connection should be available to enable use of the audible function in a high-noise environment.
SL-39 The RIID shall have a wide range of measurement of gamma and neutron radiation.
The manufacturer shall state the range for gamma-ray exposure rate or dose-equivalent rate measurement and for neutron count rate indication. The exposure rate range (or equivalent dose-equivalent rate range) should be at least 1 nR/h to 100 R/h.
Objective = Threshold IAW ANSI N42.34-2015, Section 5.12.1 and STC Requirements
SL-40 Data file configuration The RIID shall have the ability to internally store at least 100 complete identification data files and deliver them in the ANSI N42.42 and .zip format.
The .zip format shall be for individual or bulk download of file(s).
For the neutron detection capabilities, the data file shall include the following information:
1) Neutron detector kind (e.g., He-3, Li-Glass) and volume (when applicable)
2) Measured neutron radiation levels (e.g., count rate)
Objective=Threshold IAW ANSI N42.34-2015, Section 5.13.1 Each data record shall contain the following information:
a) RIID manufacturer name, model, and serial number
b) Software version
c) Gamma detector kind (e.g., NaI, polyvinyl toluene [PVT])
d) Date and time of measurement
e) Measured gamma-ray radiation level (e.g., exposure rate)
f) Background spectrum
g) Live time and real time for background spectrum
h) Measured spectrum
i) Live time and real time for measured spectrum
j) Energy calibration for the background and measured spectrum
k) Radionuclide identification results
l) Confidence indication
SL-41 The RIID shall be marked as suitable or not suitable for use in explosive atmospheres.
The manufacturer shall state in its manual whether or not the RIID is certified for use in explosive atmospheres. If certification is claimed, documentation shall be provided by the manufacturer.
Certification shall be based on UL 913.
Objective=Threshold IAW ANSI N42.34-2015, Section 5.15.1
SL-42 The RIID shall have a minimal amount of false gamma alarms.
While in a scan or search mode, the alarm rate providing an indication of radiation field changes shall be less than one alarm over a period of 1 h when tested in an area with a stable background (only natural fluctuations) at the levels stated in Table 1 of ANSI N42.34-2015.
The test method of two alarms over a time period of 5 h is based on a 95% upper confidence bound for a one-sided Poisson distribution.
Objective=Threshold IAW ANSI N42.34-2015, Section 6.2.1
SL-43 The RIID shall have a photon alarm or indication.
While searching, RIIDs shall alarm or provide an indication when the radiation field changes from ambient background to that with a source present.
Objective=Threshold IAW ANSI N42.34-2015, Section 6.3.1 For this test, the alarm or indication shall activate no later than 1 s after the RIID passes through the test point (point of closest approach) or the test point moves past the RIID.
The radiation field at the test point shall be 10 μR/h and the transient speed 0.5 m/s.
SL-44 The RIID shall display exposure rate or ambient dose equivalent, accurately.
If the RIID displays the exposure rate or ambient dose equivalent rate [H*(10)], the displayed readings shall meet the accuracy requirements (±10% of the conventionally true value) for photon dose-rate instruments as stated in ANSI N42.17A, American National Standard for Performance Specifications for Health Physics Instrumentation- Portable Instrumentation for Use in Normal Environmental Conditions, for exposure rates from 0.1 mR/h to the manufacturer-stated maximum response of the instrument.
The manufacturer shall provide calibration results as part of their report.
Objective=Threshold
SL-45 The RIID shall have an over range alarm and function in accordance with the requirements stated here.
If an RIID is exposed to a radiation field that is greater than the manufacturer-stated maximum when performing measurements, an alarm indicating for example “over-range” or “high counts” shall be activated and shall remain activated until the radiation field is reduced or the alarm is reset or acknowledged by the user.
If the alarm is reset or acknowledged by the user without the radiation field being reduced, a visual indication shall be provided indicating that the radiation field is still present.
Objective=Threshold The maximum rate must be provided by the manufacturer.
The time required to return to non-alarm condition after the radiation field is returned to background levels without any user interaction (other than acknowledging an audible alarm) shall not be greater than 30 min.
SL-46 The RIID shall identify gamma radionuclides.
The general requirements for radionuclide identification are as follows:
a) An indication shall be displayed (e.g., “not identified”) if the RIID indicates the presence of a source but is not able to identify a radionuclide.
b) The RIID should indicate if the exposure rate is too low or too high for radionuclide identification.
c) An indication should be displayed as to the confidence of the radionuclides identified. The indication should be numeric (e.g., 1 to 10). The manufacturer shall state the basis of the value.
The manufacturer shall state the radionuclides that the RIID can identify. The list of radionuclides and materials shall include those listed in Table 3 of ANSI N42.34- 2015, as a minimum. Verification testing shall include those radionuclides listed in Table 4, except for 252Cf.
6.8.3
SL-47 The RIID shall identify gamma radio nuclides.
The RIID shall be able to identify the radionuclides listed in Table 4 of ANSI N42.34-2015, (except for 252Cf) at an exposure rate of 50 μR/h above background established at the reference point of the RIID within an integration time of 2 min or that stated by the manufacturer whichever is shorter.
The medical radionuclides (99mTc, 67Ga, 131I, and 201Tl) shall be surrounded by 8 cm of PMMA for test purposes as a means to represent in-vivo conditions.
Objective=Threshold IAW ANSI N42.34-2015, Section 6.9.1
SL-48 The RIID shall be able to identify shielded gamma radiation sources.
RIIDs shall be able to identify 137Cs and 60Co while those sources are shielded by a 5 mm steel plate.
Objective=Threshold ANSI N42.34-2015, Section 6.8.4.1
SL-49 The RIID shall be able to perform simultaneous gamma radionuclide identification.
RIIDs shall be able to identify a minimum of two radionuclides simultaneously within an integration time of 2 min or that stated by the manufacturer, whichever is shorter.
Objective=Threshold IAW ANSI N42.34-2015, Section 6.9.1
SL-50 The RIID shall meet the requirements for false identification.
RIIDs shall not identify a radionuclide that is not present when operated in a stable and low ambient radiation background.
6.10.1
SL-51 The RIID shall be able to have full functionality across a wide range of operational temperatures.
RIIDs shall be able to function (including having a readable display) over an ambient temperature range from −20 °C to +50 °C.
Objective=Threshold IAW ANSI N42.34-2015, Section 7.1 If the manufacturer claims a broader range of operation, the vendor should provide 3rd party verification results.
SL-52 The RIID shall pass the test for temperature shock.
The RIID shall be fully functional within 1 h of exposure to rapid temperature changes from 22 °C to –20 °C, –20 °C to 22 °C, 22 °C to 50 °C, and 50 °C to 22 °C with each change being made in less than 5 min. The RIID shall provide an indication if it is not fully functional.
The RIID shall be fully functional within 30 minutes of exposure to rapid temperature changes from 22 °C to –20 °C, –20 °C to 22 °C, 22 °C to 50 °C, and 50 °C to 22 °C with each change being made in less than 5 min. The RIID shall provide an indication if it is not fully functional.
IAW ANSI N42.34-2015, Section 7.2.1
SL-53 The RIID shall meet the requirements for extreme temperature start up.
The RIID shall be able to operate when switched on at the cold temperature limit (−20 °C) or high temperature limit (50 °C).
Objective=Threshold ANSI N42.34-2015, Section 7.5.1
SL-54 The RIID shall function properly after exposure to certain levels of mechanical shock.
The RIID shall function properly after exposure to shock pulses of 50 g peak acceleration, each applied for a nominal 11 ms in each of three mutually orthogonal axes.
The physical condition of an RIID shall not be affected by these shocks (e.g., solder joints shall hold; nuts and bolts shall not come loose).
9.2.1
SL-55 The RIID shall pass the microphonic test.
The RIID’s response, both gamma-ray and neutron, shall be unaffected by microphonic conditions such as those that may occur from low-intensity impacts from sharp contact with hard surfaces.
Objective = Threshold IAW ANSI N42.34-2015, Section 9.3.1
Documentation and Related
SL-56 The vendor shall provide the required documentation accompanying the RIID.
The manufacturer shall provide the following information, as a minimum:
a) Contact information for the manufacturer including name, address, telephone number, fax number, e-mail address, etc.
b) Model name or number, serial number, and software and firmware version numbers.
c) Type of radiation detector(s) used (e.g., NaI, CZT, HPGe, etc).
If pressurized detectors are used (e.g., 3He), the manufacturer shall state the size, pressure, and volume of the detector.
d) Size and weight (with batteries installed).
e) Manufacturer’s website information.
f) Battery requirements.
g) Recommended operational parameters such as detector response, false alarm probability, alarm thresholds, operating
10.1 parameters, and radionuclide library(s).
h) Static measurement time.
i) Complete description of the
RIID.
j) Case specification classification.
k) Inclusion of any hazardous material that may require additional regulation (such as radionuclide check source, pressurized gases, corrosive materials).
l) List of radionuclides that are identified by the RIID.
m) Description of the confidence level indication.
n) Exposure or dose-equivalent rate range.
o) Exposure or dose-equivalent rate calibration results.
p) Over-range exposure rate values for gross counting and identification.
q) Energy range.
r) Full width-half max (FWHM) value for 137Cs
SL-57 The vendor shall provide the appropriate manuals for the RIID, in electronic and hard copy form, as required.
The manufacturer shall supply an operation and maintenance manual (paper or electronic) containing the following information for the user:
a) Operating instructions and restrictions
b) Functional verification process
c) Spare parts list
d) Troubleshooting guide
10.2
e) Description and protocol for communication methods of transmitting and receiving data
f) Photos or schematic drawings that describe the location of the detector(s) and associated reference point(s)
SL-58 The RIID shall be able to transfer files to approved cellular phones and tablets.
The RIID shall be able to connect phones and tablets (Android OS
8.0 or better) via Bluetooth 4.0 or better and transfer saved files in a native (N42 or pdf) and zip format.
Objective=Threshold STC Requirement
The RIID shall be able to be configured by the operator to transfer files from the RIID to the “Photos” or “Media” folder on the root directory of the phone/tablet. The saved files referenced shall include spectral files, images, voice memos and any other files stored on the RIID.
One use case for uploading spectral files involves using the mobile application Survey123 by ESRI. More detailed information will be provided upon request.
SL-59 RIIDs shall have DHS/ CWMD/STC approved inventory control stickers and be recorded on an inventory data file.
RIIDs shall be delivered with CWMD approved inventory control stickers adhered to the RIIDs and with a CD containing completed relevant sections of a bulk upload inventory spreadsheet.
Objective=Threshold STC Requirement
SL-60 The vendor shall ensure that the RIID data can be ingested and used by various smart phone applications.
Vendor shall provide smart phone application for logging/storing stored data and alarms, with the ability to track events on integrated mapping systems. Application shall have the ability to send RIID data and associated
Objective=Threshold STC Requirement geospatial information from smart phone to a CWMD STC data center.
SL-61 The vendor shall supply electronic training as a smart phone application.
Vendor shall provide a user manual/basic functional training in the form of a mobile application, for both iOS ( 9.3 or later) and Android operating systems (8.0 or later)
Objective=Threshold
SL-62 Record and track student training and test scores taken via the interactive smart phone application.
Tracking process shall be compatible with and/or able to export compatible files to DHS/CWMD/STC's student tracking application.
Objective=Threshold STC Requirement
SL-63 Maintenance and Service 1 year, 3 year and 5 year extended warranty options shall be provided by vendor, with a list of parts and services which are included. Warranty should include a list of any parts/services which are excluded under the terms presented, if any exist. Warranty should include a way to provide pre-paid shipping labels to and from the STC region to which the RIID is assigned.
Objective=Threshold
SL-64 Service and repairs A fixed price list of replaceable parts and labor rates shall be provided, in addition to the warranty options.
SL-65 Maintenance and Service CWMD shall reserve the right to determine when and if detector crystals need replacement. This will be based on acceptable resolution thresholds as determined by CWMD. Vendor is responsible for servicing RIID if crystal resolution is within a range deemed acceptable by CWMD
STC.
Objective=Threshold STC requirement
SL-66 The RIID shall be delivered as part of a kit.
The RIID shall be delivered in a ruggedized Pelican type case with custom foam cutouts to house any cables, media, chargers, manuals, straps, protective boot/sleeve, spare batteries which are required for use of the RIID.
Objective=Threshold STC Requirement
The kit shall include any K40 or related tools needed for field operators to use for functional testing of the RIID.
SL-67 RIIDs shall have DHS/ CWMD/STC approved inventory control stickers and be recorded on an inventory data file.
RIIDs shall be delivered with CWMD approved inventory control stickers adhered to the PRDs and with a CD containing completed relevant sections of a bulk upload inventory spreadsheet.
Objective=Threshold STC Requirement
SL-68 The RIID shall be able to transfer data using the CWMD STC mobile application.
The RIID shall be able to connect to the CWMD/STC mobile application using Bluetooth 4.0 or better
Objective=Threshold Engineering work may be required on the part of the vendor to complete this requirement.
SL-69 System shall be reliable. Mean Time Between Failure [MTBF] rate of 8,760 operating hours.
Mean Time Between Failure [MTBF] rate of 17,520 operating hours.
MTBF is defined for a particular interval, as the total operating time (time that the system is operating or capable of operating) of the population of Basic Handheld devices divided by the total number of failures (requiring corrective maintenance actions). MTBF can be calculated, but acceptance of stated values is based on an explanation of the methodology used and supporting data. Field data is preferred and, if available, should be provided as justification to any specified MTBF.
SL-70 System reliability shall support a high fleet Operational Availability
[AO].
0.99 0.994 Operational Availability [AO] indicates the percentage of time that a system is operationally capable of performing an assigned mission and can be expressed as (uptime/ (uptime + downtime)). High fleet operational availability, given that the device requires no scheduled maintenance, is across the entire fleet including those devices unavailable because they are in maintenance or being shipped to and from the maintenance repair facility.
SL-71 System shall operate without scheduled maintenance.
Maintenance limited to battery replacement and external cleaning in the field without any special tools, procedures, or test equipment.
Objective = Threshold None
ANSI N42.34-2015, Section 6.8.3.2 – Used as Test method for identification of single radionuclides
aa) Analyze the results using the technique described in ANSI N42.34-2015, Annex B, step B.2.3, and Table 4a. listed below.
bb) The results are acceptable when they meet the acceptance criteria as shown in Table 4a in at least 9 of 10 trials.
Table 2a—Identification acceptance criteria1,2
Source Required identification (at least one)
Additional acceptable identification3
NORM None Thorium, Radium, 232Th, 226Ra, 40K, NORM
241Am 241Am 232Th, 226Ra, 40K, NORM 133Ba 133Ba 232Th, 226Ra, 40K, NORM 60Co 60Co 232Th, 226Ra, 40K, NORM 137Cs 137Cs 232Th, 226Ra, 40K, NORM 67Ga 67Ga 232Th, 226Ra, 40K, NORM 131I 131I 232Th, 226Ra, 40K, NORM 99mTc 99mTc 99Mo, 232Th, 226Ra, 40K, NORM 201Tl 201Tl 202Tl, 232Th, 226Ra, 40K, NORM 226Ra 226Ra, Radium 232Th, 40K, NORM
232Th 232Th, Thorium 226Ra, 40K, NORM
DU DU, U, 238U,
Uranium
235U,234mPa, 232Th, 226Ra, 40K, NORM
HEU HEU, U, 235U,
Uranium
238U, 234mPa, 232Th, 226Ra, 40K, NORM
WGPu WGPu, Pu, 239Pu, Plutonium
241Pu, 240Pu, 238Pu, 241Am, 237U, 242Pu, neutron, 233U, 232Th, 226Ra, 40K, NORM
137Cs +
DU
DU, U, 238U,
Uranium
137Cs, 235U,234mPa, 232Th, 226Ra, 40K, NORM
99mTc +
HEU
HEU, U, 235U,
Uranium
99mTc, 238U, 234mPa, 99Mo, 232Th, 226Ra, 40K, NORM
201Tl + HEU HEU, U, 235U, Uranium
201Tl, 202Tl, 238U, 234mPa, 232Th, 226Ra, 40K, NORM
67Ga + HEU HEU, U, 235U, Uranium
67Ga, 238U, 234mPa, 232Th, 226Ra, 40K, NORM
131I + WGPu WGPu, Pu, 239Pu, Plutonium
131I, 241Pu, 240Pu, 238Pu, 241Am, 237U, 242Pu, neutron, 233U, 133Ba, 232Th, 226Ra, 40K, NORM
NORM +
HEU
HEU, U, 235U,
Uranium
238U, 234mPa, NORM, Thorium, Radium, 232Th, 226Ra, 40K
NORM +
WGPu
WGPu, Pu, 239Pu, Plutonium
241Pu, 240Pu, 238Pu, 241Am, 237U, 242Pu, neutron, 233U, NORM, Thorium, Radium, 232Th, 226Ra, 40K
1 – identification of naturally occurring radioactive materials (NORM) such as 40K, 226Ra and/or 232Th is acceptable 2 – identification results may be notated differently. For example, 241Am may be shown as Am-241; “neutron” may be abbreviated to “neutr”.
3 – sources used for testing shall be checked for gamma-ray emitting impurities using a high purity germanium (HPGe) detector. Sources with impurities not listed in the table and not in the decay chain of the radionuclide(s) should not be used for testing. Medical sources may contain impurities. Identification of those impurities is acceptable.
ANSI N42.34-2015, Section 6.8.4.2 Test method for identification of shielded sources
i) Analyze the results using the technique described in Annex B, step B.2.3, and Table 4a.
ii)The results are acceptable when they meet the acceptance criteria as shown in Table 4a in at least 9 of 10 trials.
ANSI N42.34-2015, Section 6.9.2 Test method for identification of simultaneous radionuclides i)Analyze the results using the technique described in Annex B, step B.2.3, and Table 4a.
ii)The results are acceptable when they meet the acceptance criteria as shown in Table 4a in at least 9 of 10 trials.
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