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 125
• If the MKT calculation is desired the value of Heat activation can be set.
Note: Changes to lethality calculations are permitted only if given permission inside
preferences. Changes to D-Value can be permitted inside policies.
Lethality and Time of Sterilization
New European regulation have placed and emphasis
on ensuring you have proper steam quality when
calculating lethality. For this reason, we have added
additional options which if checked will only calculated
the Instantaneous lethality for the time stamp if the
Saturation Pressure and Temperature are within
defined limits set in the Time of Sterilization
calculation.
The Time of Sterilization calculates the total time of sterilization by combining the Steam quality
criterion, along with the measured reference temperature. Time is counted if the measured reference
temperature is at or above the process temperature and the steam quality as defined by Temperature
minus calculated Saturation Temperature (T-Sat) is within the specified range.
Figure 136: Time of Sterilization – Definition of Limits
Press Back to return to the Edit Parameters screen.
If Edits are completed or no edits were required press the Next arrow to proceed.