User's Guide
4
radio frequency energy and, if not installed and used in accordance with the provided
instructions, may cause harmful interference to radio communications.
• Portable and mobile RF communications equipment can affect medical electrical
equipment. If you encounter RF interference from a mobile or stationary RF transmitter,
move away from the RF transmitter that is causing the interference.
• Be careful when using the Simplera™ sensor closer than 30cm (12in) to portable radio
frequency (RF) equipment or electrical equipment. If the sensor must be used next to
portable RF equipment or electrical equipment, observe the sensor to verify correct
system operation. Degradation of the performance of the sensor could result.
• The essential performance (EP) of the Simplera™ sensor is to measure and transmit to
a monitoring device the sensing device’s signal value(s) within the sensor’s accuracy
requirements under the specified use conditions outlined in the Simplera™ system
user guide and for the duration of the expected service life. If the sensor experiences
electromagnetic disturbances, either no or incorrect data may be transmitted. In such
situations, refer to the operation, maintenance, and troubleshooting instructions within
the applicable user guides. If the sensor is damaged or if it cannot communicate with
the display device, contact 24‑Hour Technical Support for assistance.
Risks
General risks with Simplera™ sensor use include the following:
• Skin irritation or other reactions
• Bruising
• Discomfort
• Redness
• Bleeding
• Pain
• Rash
• Infection
• Raised bump
• Appearance of a small freckle‑like dot where needle was inserted
• Allergic reaction
• Fainting secondary to anxiety or fear of needle insertion
• Soreness or tenderness
• Swelling at insertion site
• Sensor filament fracture, breakage, or damage
• Minimal blood splatter associated with sensor needle removal
• Residual redness associated with adhesive or tapes or both
• Scarring