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 105
Lethality
The Accumulated Lethality graph displays lethality totals for each included sensors at
each timestamp programmed or defined to calculate lethality. Alternatively, the lethality
accumulation can be displayed as a bar graph.
Sat P
The Saturation Pressure calculation is only available if the study includes at least one
temperature sensor and pressure sensors.
The Saturation Pressure vs. Measured Pressure graph displays measured pressure from
the selected pressure sensor and the saturation pressure calculated from the temperature
sensors selected in the Edit Sensors screen. To access the Saturation Pressure vs.
Measured Pressure graph, select Temp and Pressure Sensors group from Select Group
drop-down list.
Sat T
The Saturation Temperature calculation is only available if the study includes at least one
pressure sensor along with temperature sensors.
The Saturation Temperature vs. Measured Temperature graph displays the saturation
temperature calculated from the selected pressure sensor and the measured temperature
from the sensors selected in the Edit Sensors screen. Red horizontal lines on the graph
display the base temperature (Tb) entered during the study setup, and the base
temperature +3 K. The text at the bottom of the graph displays if the data passed or failed
three conditions:
• All measured temperatures and the calculated saturation temperature are
within the specified sterilization temperature band.
• Each measured temperature and the calculated saturation temperature do
not fluctuate more than 1 K.
• All measured temperatures and the calculated saturation temperature do not
differ from each other by more than 2 K.
Equilibrium
The Equilibration Time graph displays whether all temperature sensors in the Edit
Sensors list reached the lethality base temperature within a 15 or 30 second time period,
satisfying the equilibration conditions.
Regulations require that sterilization chambers less than 800 liters have an equilibration
time no greater than 15 seconds; sterilization chambers greater than 800 liters should
have an equilibration time of no more than 30 seconds.
This graph is only available if the sensors had a one second sampling rate, and at least
one sensor reached the lethality base temperature. If you did not define the lethality base
temperature during the study setup, the default temperature of 121.1°C is used.