Sensitivity To Foreseeable Environmental Conditions Under Normal Use Conditions; Cautions In Case Of Equipment Disability; Liability Statement - WEM SS-200E Manual De Utilización

12 – Sensitivity To Foreseeable Environmental Conditions Under Normal Use
Conditions
The Microprocessed Electrosurgical Unit model SS-200E has been designed to avoid sensitivity such as
interferences as magnetic fields, extreme electrical influences, electrostatic discharges, pressure or
pressure variation, provided that the equipment is installed, kept clean, preserved, transported and
operated according to this User Manual.
13 – Cautions In Case of Equipment Disability
The following risks are identified, which are associated with disposal of disposable products, residues, etc,
the equipment and accessories, at the end of their life cycle:
Contamination
-
Improper reuse or use after the life cycle, and consequent malfunction of equipment and accessories,
-
resulting in injuries/burns to user or patient
To minimize the risks above, the following actions should be taken:
a. Equipment
Equipment uses no disposable items or generates no residues after its use; however, after its life cycle, the
equipment must be disposed in an appropriate area (according to local law).
b. Accessories
For accessories coupled to the equipment, the following actions should be taken:
Disposable items
-
Those include disposable pencils, disposable patient plates and disposable electrodes.
All such items, after their use, should be disposed to an appropriate area as hospital waste and identified
as such, and then removed by entities authorized to remove hospital waste.
Reusable items
-
Those include reusable pencils, reusable patient plates and reusable electrodes.
All such items, after their life cycle, should be disposed to an appropriate area as hospital waste and
identified as such, and then removed by entities authorized to remove hospital waste.
14 – Liability Statement
The company WEM Equipamentos Eletrônicos Ltda, represented by its Technical Officer, Engineer Thiago
Soares da Silva Fernandes and its Legal Representative, Gustavo de Paula e Silva Rahal, assume the
technical and legal responsibility for the equipment and for the veracity of all information related to the
equipment Microprocessed Electrosurgical Unit model SS-200E, provided in this User Manual.
Eng. Thiago Soares da Silva Fernandes
CREA-SP No. 5063009837
Technical Representative
Gustavo de Paula e Silva Rahal
Legal Representative
WEM / SS-200E User Manual
Rev. 11
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