Users Manual Part 2
Table Of Contents
- Appendix B. Regulatory Compliance and Agency Approvals
- Chapter 1. Kaye ValProbe RT System
- Chapter 2. Kaye ValProbe RT Hardware
- Chapter 3. ValProbe RT System Connections
- Chapter 4. Creating User Accounts
- Chapter 5. Defining Equipment
- Chapter 6. Defining Assets
- Chapter 7. Defining Study Setups
- Chapter 8. Viewing Live Data
- Chapter 9. Qualification Study
- Chapter 10. Sensor Verification
- Chapter 11. Qualification Reports
- Appendix A. Specifications
- A.1 Kaye ValProbe RT System
- A.1.1 List of Certified Countries
- A.1.2 Regulatory Compliance
- A.1.3 RF System Operating Frequency and Modulation
- A.1.4 RF Channels
- A.1.5 RF Network Topology and PAN ID (Network ID)
- A.1.6 Antenna Diversity
- A.1.7 Data Rate and Data Encryption
- A.1.8 RF Range (Line of Sight and Outdoor)
- A.1.9 Number of Loggers and Sensors Supported
- A.1.10 Sensor Sampling Rate
- A.1.11 Data Transmission Rate
- A.1.12 Sensor Samples Data Storage Capacity
- A.1.13 Optional Extendable Base Station Antenna
- A.2 Kaye ValProbe RT Base Station
- A.2.1 Input Power and Adaptor Ratings
- A.2.2 Installation Category
- A.2.3 Overvoltage Category and Electrical Safety Protection Class
- A.2.4 Input DC Power On/Off Switch
- A.2.5 Front Panel LED Indications and Buzzer
- A.2.6 Bath and IRTD Interface Ports
- A.2.7 USB Port
- A.2.8 Ethernet Communication Port
- A.2.9 Reset Switch to Reload Default Factory Settings
- A.2.10 Wakeup Magnet
- A.2.11 Batteries
- A.2.12 Unit Dimensions
- A.2.13 Enclosure Material
- A.2.14 Environmental Ratings
- A.3 Kaye ValProbe RT Logger
- A.3.1 Installation Category
- A.3.2 Overvoltage Category and Electrical Safety Protection Class
- A.3.3 Magnetic Switch
- A.3.4 LED Indications
- A.3.5 Calibration
- A.3.6 Real Time Clock Accuracy
- A.3.7 Sensing Elements
- A.3.8 Housing Material
- A.3.9 Logger Base Dimensions
- A.3.10 Ingress Protection
- A.3.11 Insulating Canister X2545
- A.3.12 Battery
- A.3.13 Shelf Life
- A.3.14 Battery Life
- A.4.1 Measurement Accuracy
- A.4.2 Body Environmental Ratings:
- A.4.3 Number of Input Channels
- A.4.4 Sensor Types and Measurement Range
- A.4.5 Sensor Lengths
- A.5.1 Measurement Accuracy
- A.5.2 Body Environmental ratings:
- A.5.3 Number of Input Channels
- A.5.4 Sensor Types and Measurement Range
- A.5.5 Sensor Lengths
- A.6.1 Measurement Accuracy
- A.1 Kaye ValProbe RT System
- Appendix B. Regulatory Compliance and Agency Approvals
- B.1 Electrical Safety Approvals:
- B.2 Radio and EMC Certification Approvals:
- B.3 Ingress Protection for Kaye ValProbe RT Logger
- B.4 United States FDA 21 CFR Part 11 Complaint Software Application
- B.5 Transportation Regulations
- B.6 FCC Compliance Statement
- B.7 ISED Canada Compliance Statement
- B.8 EU Compliance Statement:
- B.9
- Product Certification Labels
- Appendix C. Environnemental Compliance
- Appendix D. Warranty and Returns:
- Appendix E. Service Information
Chapter 11: Qualification Reports
Kaye ValProbe RT User Manual 114
Figure 124: Template to Group Screen
Users can return to and select different templates for different groups (i.e. Distribution,
Penetration or different chambers in one study.
Pass / Fail Criteria Calculations
A User can select up to 16 commonly utilized and regulatory driven criteria to customize their
reports based on their specific needs. The following definitions help clarify how these criteria
are utilized and applied:
Note: Only values that are outside the defined criteria are considered “Failed”. All values that
are equal to or within the defined criteria defined criteria are considered as “Pass”.
Each Group included in the Pass/Fail Criteria Report shall have a separate analysis
and report based on each group of sensors.
Process Temp Band: Using the defined process temperature as a basis, the criterion
describes an allowable temperature band above and below the process temperature. The
criterion is defined as the number of degrees above or below the criteria. For example, if the
Process Temperature is 121°C and you enter a max value of 2 and min value of –2, the
application checks whether all the sensor values are within 123 (121 + 2) and 119 (121 - 2).
The criterion only “Passes” if all sensor readings are equal to or within the range of 119°C to
123°C.
Temperature Fluctuation (Max-Min) per Sensor: The Temperature Fluctuation (Max-Min)
per Sensor field defines the max fluctuation allowed for each sensor during the cycle. The
criterion “Passes” if all sensors (Max – Min) readings are equal to or less than the defined
criteria.
Temperature at / above Process Temp per Sensor: The Time at/above Process
Temperature per Sensor calculates for each sensor the total time for each sensor equal to or
above the process temperature during the cycle. The criteria fields allow the definition of the
maximum time, the minimum time or both. To meet the minimum criteria all sensor calculated
times must be equal to or above the minimum criteria. To meet the maximum criteria all
sensor calculated times must be equal to or below the maximum criteria. If both maximum and
minimum are specified, then all sensor calculated time must be equal to or within the defined
range.