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ATTENTION - This sensor does NOT monitor ICP in mmHg and therefore the waveform shown in a monitor should be assessed only by its morphology and NOT absolute value. |
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3.1.1 indications for use
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WARNING - This sensor must only be operated by trained and qualified health professionals, who are responsible for knowing the protocol guiding usage of the sensor as well as the care related to its purpose and use in patients. |
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3.1.2 target population
Adult patients ages 18 years of age or older with suspected intracranial hypertension or changes in intracranial compliance.
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3.1.3 collateral or side effects
Allergic reactions due to hypersensitivity to sensor components.
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3.1.4 contraindications
The system is contraindicated for use in patients under 18 years of age.
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Undergone decompression craniectomy;
Cranial defects (portions of skull missing);
Patients with hypersensitivity to sensor components;
Any other conditions that the healthcare professional deems unsuitable for use of this device.