Medela Thopaz+ - 3 Description; Intended use;indications

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Description | 13
3 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 the fluid
collection. Thopaz
+
only applies vacuum required to maintain the negative pressure pre-
scribed and set by the managing physician. The digital colour display provides objective data
in real time as well as in historical graphs, which allows easy tracking of the therapy progress.
It 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.
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.
Service life
The service life of the device is five years.
Intended patient population
Thopaz
+
is intended to be used on patients only exhibiting conditions as described in the
indications for use.
Intended user
Thopaz
+
should only be operated by properly instructed users. These persons must not be
hard of hearing or deaf and must have adequate visual faculty.