Gyrus Acmi PlasmaKinetic SuperPulse, Руководство пользователя

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SECTION 3 INSTALLATION
Gyrus ACMI PlasmaKinetic SuperPulse Generator USER MANUAL
Part Number: 144012-MB
Page 3-1
The electrosurgical generator described in this manual, in conjunction with the Gyrus ACMI PK
Instruments, is designed to provide advanced electrosurgical effects during endoscopic surgery.
3A. Responsibility of the Manufacturer
The manufacturer is responsible for safety, reliability and performance of the equipment
only if:

Installation procedures in this manual are followed.

Assembly operations, extensions, re-adjustments, modifications or repairs are
carried out by persons authorized by the manufacturer and the electrical
installation of the relevant operating room complies with local codes and
regulatory requirements.

The equipment is used in accordance with this User Manual and the Instructions
For Use that accompany all system accessories.
3B. Generator Power Requirements
Please refer to section 10-1 for full voltage details.
Check the Generator Power Connection
The power connector meets all requirements for safe grounding. Its purpose should not be
defeated by using extension cords or any form of adaptor. When disconnecting from the
mains socket or from the generator, cords should always be grasped by the plug. Do not
pull on the cord itself.
3C. Grounding of the Generator
To ensure user safety, the generator must be properly grounded through the inlet plug and
power cord. Use only hospital grade power cords.
IMPORTANT
Ensure that the electrical installation of the relevant room complies with
local codes and regulatory requirements.
3D. Routine Maintenance of the Superpulse Generator
It is recommended that the generator be inspected by qualified service personnel in
accordance with Section 13, Periodic Equipment Safety Checks.
3E. Medical Electrical Systems
When the Superpulse generator forms part of a medical electrical system (as defined in EN
60601-1 2.201) or is used with an endoscope that is compliant with EN 60601 2-18 the
following applies:

The Superpulse generator is to be placed outside the patient environment.

The Superpulse generator footswitch accessory is to be placed outside the sterile field.

The instruments intended for use with the Superpulse generator are suitable for use
inside the patient environment.
WARNING
Multiple portable socket outlets shall not be placed on the floor.
WARNING
Additional multiple portable socket outlets or extension cords shall NOT be
connected to the system.
SECTION 3
INSTALLATION