Edwards ForeSight IQ Bedienungsanleitung

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English
ForeSight IQ
Large Sensor
FSESLIQ
≥ 40 kg - Adult
Carefully read these instructions for use, which address the warnings, precautions, and residual risks for this medical device.
1.0 Description
The sensor, when used in combination with the ForeSight oximeter cable is a single use applied part that measures hemoglobin allowing the clinician to continuously and accurately determine
absolute levels of blood oxygenation saturation in the tissue (StO 2 ). This device is supplied non-sterile.
Device performance, including functional characteristics, have been verified in a comprehensive series of testing to support the safety and performance of the device for its intended use when used
in accordance with the established Instructions for Use.
The device is used by clinicians who have been trained in the use of tissue oximetry devices in accordance with their institutional policies.
The benefit of using ForeSight sensor is to non-invasively provide tissue oxygen saturation and hemoglobin values to allow clinicians to manage their patients. Potential risks include burns,
electrical shock, tissue damage, transient hypoxia, adverse reaction to device materials, and/or inappropriate/unintended treatment.
2.0 Intended Use/Purpose
When used with the HemoSphere Alta advanced monitoring platform in combination with the ForeSight oximeter cable, the intended purpose is to monitor absolute regional hemoglobin oxygen
saturation of blood under the sensor.
3.0 Indications for Use
When used in conjunction with the ForeSight oximeter cable:
The ForeSight IQ large sensor is indicated for monitoring of absolute regional hemoglobin oxygen saturation of blood under the sensor in individuals at risk for reduced flow or no-flow ischemic
states. It is intended for use on adults and transitional adolescents ≥ 40 kg .
4.0 Contraindications
The sensor is contraindicated for use on patients:
• With a physical site area too limited for proper sensor placement
• With allergic reactions to sensor adhesive
• Undergoing an MRI scan because of associate risk of injury
Edwards, Edwards Lifesciences, the stylized E logo , ForeSight, ForeSight IQ, HemoSphere, and HemoSphere Alta are trademarks of Edwards Lifesciences Corporation. All other trademarks are the
property of their respective owners.
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