User's Manual
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 120
11.8.
Generating Qualification Reports
Before selecting a report type, the ValProbe RT software permits the user one last opportunity
to verify or edit parameters such as:
• Start / Stop conditions (Marking Cycles)
• Sensor groupings
• Sensor calculations
Using these parameters, any errors or omissions can be corrected before generation of the
report.
These changes do not affect the raw sensor data, or storage rate of the Qualification file. All
changes made during these steps are documented in the report.
To begin the Qualification report generation, perform the following steps.
Selecting a Qualification File
To select the Qualification file, select the Asset where the Qualification was initiated from.
Select the Qualification tile, then the desired raw encrypted Qualification file and press the
Generate Reports button.
Select the Bar Graph icon for the selected Qualification file.
A Select Sensor Type pop-up appears requesting the measurand type to graph when defining
cycles. Select the appropriate sensor type and press OK to open the Mark Cycles Graph. For
sterilizers, the option to use both temperature and pressure provides a better understanding
for when both requirements are reached.
Figure 127: Select Sensor(s) Type
Mark Cycles
Before generating Qualification reports, use the Define Qual/ Exposure screen to review, or
modify, the Qual Start/ End and or Exposure Start / End cycles times from the Qualification
study data. Each cycle is defined with a start and end time which define the cycle duration.
The defined cycles are used in the Qualification Summary and Pass/Fail Criteria report to
provide detailed calculations and analysis during specified cycles.