Intended Use - GCE MEDIEVAC+ Betriebsanleitung

ENGLISH
INSTRUCTION FOR USE: MEDIEVAC+
1. FOREWORD
GCE Vacuum regulators are medical devices classified as class IIa
according to the Medical Device Directive 93/42/EEC.
Their Compliance with essential requirements of 93/42/EEC Medical De-
vice Directive is based upon EN ISO 10079-3 standard.

2. INTENDED USE

MediEvac+ is a variable control medical suction equipment powered from
a vacuum source used for vacuum regulation.
MediEvac+ is intended for suction of blood and body liquids from any parts
of patient´s body mainly during surgical operations, resuscitation, chesty
and gastritic drainage, etc.
The product is not intended to be powered from:
• a venturi vacuum source
• a pressure gas source.
The product is not intended for:
• field use
• direct(*) use during thoracic drainage
The "250mbar" variant is not intended to be used for Pharyngeal suction.
(*) For thoracic drainage therapy, MediEvac+ can be used as a first stage
vacuum source setting device to power a thoracic drainage system.
In this case, the user must ensure that the complete set (MediEvac+ + Tho-
racic drainage system) meets the requirement of ISO 10079-3 appropriate
sections
Read this instruction before use of the product. Always follow this in-
struction!
The product shall only be used for the purpose described in this instruc-
tion!
The product must be installed and used by a qualified person and by
compliance of all requirements of standards EN ISO 10079-3 as amended!
Before use, to guarantee the safety of the patient, check the equipment
and the accessories used with the product, so that data and performance
comply with the intended use of the product!
The product must not, under any circumstances be modified by other
than the manufacturer!
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EN