Caution In Endoscopic And Laparoscopic Surgeries; Warnings And/Or Precautions During Disinfection And Cleaning; Equipment Performance Related To Essential Medical Equipment Safety And Effectiveness Requirements And; Indication, Purpose And Intended Use Of Equipment - WEM SS-200E Manual De Utilización

 Use of accessories and cables not specified in this manual may result in increased emission or
decreased immunity in equipment. WEM does not recommend the use of accessories that are not
specified in this manual.
4.9 – Cautions in endoscopic and laparoscopic surgeries
 After electrosurgical unit deactivation, the electrode tip may remain sufficiently hot and produce burns.
 A negligent activation of electrosurgical unit or the movement of an activated electrode out of the field
of vision may result in harm to the patient.
Deviations of current connected by conductive objects, such as trocars, may produce localized burns in
both the patient and surgeon. Such currents may be generated in two ways: by direct contact of a metallic
object with the active electrode or the proximity of active electrode or its cable in relation of the conductive
object.
4.10 – Warnings and/or precautions during disinfection and cleaning
Before cleaning the equipment, check if it is powered off.
To clean the equipment externally, use a damp cloth. Take care to prevent any liquid from penetrating the
equipment. If liquid penetration cannot be avoided, abstain from switching the equipment on and call
immediately the Authorized Technical Assistance.
Do not use microabrasive material or steel wool for cleaning, or organic solvents or detergents containing
such solvents as ether, cleaner, gasoline, etc. Do not use aerosol or other devices based on liquid spray.
5 – Equipment Performance Related To Essential Medical Equipment Safety and
Effectiveness Requirements and Eventual Undesirable Secondary Effects
5.1 – Indication, purpose and intended use of equipment
Indication...: Removal, cut or coagulation of biological tissues.
Purpose..: Cut and coagulation of biological tissues in diverse surgical procedures.
5.2 – Undesirable secondary or collateral effects and contraindications
The equipment will produce no undesirable secondary or collateral effects if all recommendations of this
User Manual are followed. The equipment has no contraindication. It may only be used or operated by a
qualified professional (physician) or under his/her supervision.
5.3 – Equipment safety and effectiveness
The equipment meets the electromedical equipment safety standards NBR IEC 60601-1, NBR IEC 60601-
2-2 and NBR IEC 60601-1-2, and the effectiveness of its use is obtained as long as the recommendations
set out in this manual are followed.
6 – Installation or Connection To Other Equipment
SS-200E has adequate characteristics that allow its use with argon beam coagulators. Its installation or
connection is made according to the specifications of each manufacturer. It may only be used with
equipment or accessories complying with NBR IEC 60601-1, NBR IEC 60601-2-2 and NBR IEC 60601-1-
2 standards.
WARNING: use of any part, accessory or material not specified is the full responsibility of the user.
7 – Installation, Corrective and Preventive Maintenance
7.1 – Equipment installation
Upon unpacking the equipment, check for any apparent damages caused by falls or inadequate handling
during transportation. Should that occur, contact immediately the carrier to obtain guidance about actions
to be taken.
WEM assumes liability for equipment safety, reliability and performance to the extent that:
1. The equipment is used according to use directions included in this manual.
2. Electrical wiring is in accordance with Brazilian standards in force for hospital facilities.
WARNING: To prevent the risk of electric shock, this equipment should be connected only to a
mains source provided with protective grounding.
ESE protection against effects from defibrillator discharge will depend on the use of appropriate
cables.
A ventilation space of 10-15 cm in sides, base and cover of the chassis should be provided.
WEM / SS-200E User Manual
Rev. 11
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