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Defines the intended use of the LINA Librata device for treating menorrhagia in pre-menopausal women.
Lists patient conditions and situations where the LINA Librata device should not be used.
Provides critical safety information regarding device handling, sterility, and usage limitations.
Details possible adverse events and complications associated with the endometrial ablation procedure.
Advises on precautions for patients with certain uterine conditions, history, or anatomical variations.
Step-by-step guide on how to safely abort the treatment process using the device's abort function.
Detailed sequence of actions for preparing and performing the LINA Librata endometrial ablation.
Explains device alarm patterns, their associated error reasons, and recommended user instructions.
States the device's compliance with the European Medical Device Directive and relevant standards.
Defines the meaning and significance of various symbols found on the LINA Librata device labeling.
General| Brand | LiNA |
|---|---|
| Model | Librata |
| Category | Medical Equipment |
| Language | English |
