00732467 Rev. D
Page
53
of
110
Essential Performance
The gi4000 ESU is intended to operate in a flexible endoscopic clinical environment using high
frequency energies that preform cutting and coagulation therapeutic effects at the surgical site.
Safe and efficacious use of the gi4000 is directly controlled by the physician or the operating
personnel and when in a non-activated state poses negligible risk to the patient, surgical staff or
environment. The clinical essential performance of the gi4000 is directly related to proper use,
setup and immunity to external environmental (EMC) disturbances.
The gi4000’s essential performance is providing proper method of operation, e.g., monopolar or
bipolar, when selected by the operator, for a specific desired clinical result; providing proper mode
of operation, e.g., argon, cutting or coagulation, when selected by the operator, for a specific
desired clinical result; operating in the requested state only during user activation; providing proper
output characteristics, including power settings and surgical energies, when the operator has
activated the desired clinical characteristics at the lowest setting and shortest activation time to
achieve desired clinical effect; providing safe and efficacious surgical effects when the generator
is placed into and setup properly for flexible endoscopic surgical procedures; providing safe and
efficacious surgical effects, only when activated, while subjected to external EMC disturbances;
providing safe and efficacious monopolar surgical effects when proper placement and use of a
sensing return electrode or non-sensing return electrode thus minimizing alternate surgical site
injuries; ensuring the generator deactivates all output characteristics when an internal or external,
such as EMC disturbances or dislodging of return pad, fault is detected by the internal sensing
systems.
Observing the essential performance of the gi4000 provides a high level of protection of health
and safety while conducting flexible endoscopic clinical procedures. Any risks which may be
associated with the use of the generator, has been reduced to a level of “As Low As Possible”,
and any residual risk is outweighed by the benefits and safety of the clinical procedure.
Содержание G1110001
Страница 1: ...gi4000 Electrosurgical Unit Reference Reorder No G1110001 User and Maintenance Manual ...
Страница 6: ... This page is intentionally left blank ...
Страница 54: ...00732467 Rev D Page 48 of 110 8 11 9 Bipolar Method Figure 8 25 Figure 8 26 Figure 8 27 ...
Страница 109: ...00732467 Rev D Page 103 of 110 Figure 13 21 Argon RF Output Test Diagram ...
