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| Warning |
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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. |
3.1.2 target population
Patients Adult patients ages 18 years of age or older with suspected intracranial hypertension or changes in intracranial compliance.
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The system is contraindicated for use in patients under 18 years of age.
The system is contraindicated for use in adult patients 18 years of age or older who have:
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.