Intended use
4 Description
Introduction
Thopaz is a high-quality digital chest drainage system. The compact system provides
regulated negative pressure close to the patient's chest. It monitors the air leak and only
applies the suction required to maintain the negative pressure prescribed and set by the
managing physician. The digital display provides objective data in real time as well as a
24-hour historical graph of the air leak, which allows easy tracking of the therapy progress.
The system combines easy handling and cleaning with safety features to ensure optimal
operation.
Intended use / indications
Thopaz is intended to be used for aspiration and removal of surgical fluids, tissue, gases,
bodily fluids or infectious materials. Thopaz is indicated for all situations where chest drains
are applied - especially for thoracic drainage in the pleural and mediastinal cavity in situations
such as pneumothorax, after cardiac or thoracic surgery (post-operative), thorax injury,
pleural effusion, pleural empyema or other related conditions.
Thopaz is intended for use on patients in appropriate care settings.
Contraindications
There are no known contraindications for the Thopaz digital chest drainage system.
Intended user
Thopaz should only be operated by trained users. These persons must not be hard of hearing
or deaf and must have adequate visual faculty.
Intended patient population
Thopaz is intended to be used on patients only exhibiting conditions as described in
the indications for use.
Important note
Compliance with proper surgical procedures and techniques is the responsibility of the
physician. Each physician must evaluate the appropriateness of the treatment based on
his own knowledge and experience.
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Description