Indications; Contraindications; Intended User; Intended Patient Population - Medela Vario Instrucciones De Uso

Indications

Thoracic drainage: For thoracic drainage, the Vario 8 must be used in combination with
components of the Medela Thorax Drainage System (disposable canister, trolley). Otherwise
Medela cannot guarantee a safe function of the system.
Gastric suction: Only with Vario 18 c / i: When the device is used for gastric suction, the patient's
condition and correct functioning of the pump (on the basis of acoustic and visual signs) must be
checked at least once every four hours.
ENT indications: For patients for whom a breakdown of the device can lead to a critical situa-
tion (e.g. patients with acute dyspnoea or severe catarrhal congestion), a replacement device
must always be available.

Contraindications

Not suitable for setting at a low vacuum, as needed for example for thoracic drainage without
specialized accessories.

Intended user

The Vario should only be operated by properly trained staff. These persons must not be hard
of hearing or deaf and must have adequate visual faculty. The training has to be refreshed at
least once a year.

Intended Patient Population

The Vario 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.
Service life
The service life of the device is three years.
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