User's Manual
Table Of Contents
- About this Manual
- Product Description, Indications for Use, Contraindications, and Features
- Safety Information, Warnings, and Cautions
- Chapter 1: Technology Overview
- Signal Extraction Technology (SET)
- rainbow Pulse CO-Oximetry Technology
- Pulse CO-Oximetry vs. Drawn Whole Blood Measurements
- General Description for Total Hemoglobin (SpHb)
- General Description for Total Arterial Oxygen Content (CaO2)
- General Description for Carboxyhemoglobin (SpCO)
- General Description for Methemoglobin (SpMet)
- SpCO, SpMet, and SpHb Measurements During Patient Motion
- rainbow Acoustic Monitoring (RAM) Technology
- Chapter 2: Radical-7 Descriptions
- Chapter 3: Setup
- Chapter 4: Operation
- Using the Touchscreen and Buttons
- Using Screenlock
- Using the Home Button
- Navigating the Radical-7
- About the Display View
- Accessing the Main Menu
- Navigating the Main Menu
- Parameter Settings
- Sounds
- Device Settings
- Trends
- About
- Chapter 5: Configurations
- Chapter 6: Alarms and Messages
- About Alarms
- Silencing the Alarms
- Adaptive Threshold Alarm (ATA) Feature
- 3D Alarms
- Messages
- Replace Sensor Message
- Replace Cable Message
- Replace Adhesive Sensor Message
- Incompatible Sensor Message
- Incompatible Adhesive Sensor Message
- No Adhesive Sensor Connected Message
- Interference Detected Message
- SpO2 Only Mode Message
- Low Battery Message
- Low Perfusion Index Message
- Low Signal IQ Message
- Low SpCO SIQ Message
- Low SpMet SIQ Message
- Low SpHb SIQ Message
- Speaker Failure Message
- No Cable Connected Message
- No Sensor Connected Message
- Pulse Search Message
- Sensor Initializing Message
- Sensor Off Patient Message
- Service Required Message
- Incompatible Cable Message
- Chapter 7: Troubleshooting
- Troubleshooting Measurements
- Signal Indication and Quality Indicator (SIQ)
- Dimly Lit Parameters
- Low Perfusion
- Low Signal Quality
- SpO2 Values Do Not Correlate With Clinical Assessment or Arterial Blood Gas Measurements
- Unexpected SpO2, SpCO, SpMet, or SpHb Reading
- Unexpectedly High SpCO Reading
- Difficulty Obtaining a Reading
- SpCO Reading Displays as Dashes
- Troubleshooting the Radical-7
- Troubleshooting Measurements
- Chapter 8: Specifications
- Performance
- Accuracy
- Resolution
- Electrical
- Environmental
- Physical Characteristics
- Trending
- Alarms
- Display Indicators
- Compliance
- Output Interface
- Wireless Radio (If Installed)
- Serial Interface Specifications
- Serial Interface Setup
- Analog Output and Nurse Call Specifications
- Symbols
- ISO Country Codes (FCC and EU)
- Citations
- Chapter 9: Service and Maintenance
- Appendix: Best Practices for Comparisons to Reference Measurements
- Index
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Safety Information, Warnings, and
Cautions
The following section lists warnings, caution, notes, and safety information.
The Radical-7 is designed to minimize the possibility of hazards from errors in the software
program by following sound Engineering Design Processes, Risk Analysis and Software
Validation.
The Radical-7 is to be operated by qualified personnel only. The manual, accessories,
directions for use, all precautionary information, and specifications should be read before
use.
Always use the Radical-7 precisely in accordance with the directions in this manual,
including finger selection, finger alignment in the sensor, and subject behavior during
testing. Failure to follow all of the directions in this manual could lead to inaccurate
measurements.
Caution
For SpHb, the Radical-7 should be considered an early warning device. Blood
samples should be analyzed by laboratory instruments prior to clinical
decision making to completely understand the patient’s condition.
Caution
Variation in hemoglobin measurements may be profound and may be
affected by sample type, body positioning, as well as other physiological
conditions. As with most hemoglobin tests, Radical-7 test results should be
scrutinized in light of a specific patient’s condition. Any results exhibiting
inconsistency with the patient’s clinical status should be repeated and/or
supplemented with additional test data.
Parameter Related Safety Information, Warnings, and
Cautions
This section contains parameter related safety information.
Caution
If patient hypoxemia is indicated, blood samples should be analyzed by
laboratory devices to completely understand the patient’s condition.
Caution
Confirm offset values(s) periodically as the difference between the displayed
parameter value and the laboratory reference value may vary over time.