Cooper Surgical LEEP System 1000, Руководство по эксплуатации

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LEEP System 1000
®
Workstation • Model KH1000A • Operating Manual • English
(continued)
Section 8 KH1000A Accessories
NOTE: Use only genuine CooperSurgical KH1000A accessories (patient return pads, hand pencils,
electrodes and smoke evacuation disposables) for optimal system performance and patient safety. The
use of non-CooperSurgical authorized and genuine accessories is not recommended nor have been
tested and verified to the level of safety and performance of a genuine CooperSurgical accessory.
Contact CooperSurgical for a list of current genuine KH1000A accessories.
Section 9 Periodic Safety Checks and Maintenance
9.1 LEEP System 1000
®
Electrosurgical Generator
The following safety checks should be performed at least every 24 months by a qualified person who has
adequate training, knowledge and practical experience to perform these tests.
•
Inspect the equipment and accessories for mechanical and functional damage
•
Inspect the relevant safety labels for legibility
•
Inspect the fuse to verify compliance with rated current and breaking characteristics
•
Inspect acoustical and visual alarms/displays
•
Verify that the device functions properly as described in the Directions for Use
•
Verify that the device shuts down the applied part circuit if the neutral electrode is disconnected
•
Test the protection earth resistance according to IEC 601-1/1988: Limit 0.2 ohm
•
Check that the output power is within tolerance versus the output control setting at a specified
load resistance
•
Check the power output at full and half setting of the output control over the range of load resistance
as specified in the instructions for use (max. deviation is ± 20%)
•
Test the enclosure leakage current according to IEC 601-1/1988: Limit 100µA
•
Test the leakage current according to IEC 601-1/1988: Limit 100µA (BF)
•
Test the patient leakage current under single fault condition with main voltage on the applied part
according to IEC 601-1/1988: Limit: 5mA (BF)
The leakage current should never exceed the limit. The data should be recorded in an equipment log. If the
device is not functioning properly or fails any of the above tests, the device must be repaired.
9.2 Smoke Evacuator
No maintenance is required during normal operation other than ensuring that ample space is
maintained around the Smoke Evacuator to allow for free air flow and adequate cooling.
CAUTION
Make sure that the Smoke Evacuator unit is not operated for more than 15 minutes at a time.
Allow the Smoke Evacuator to cool off a minimum of 15 minutes before turning back on.
Section 10 Safety Circuits
The Electrosurgical Generator is equipped with two safety circuits. The first one checks the Dispersive Patient
Plate connection. The second one turns off the power in case of an internal failure. When activating the
Electrosurgical Generator by the Foot Pedal, a power delivery higher than the one selected will stop power
delivery and at the same time give an audible signal similar to the Patient Plate alarm, but at a higher
frequency.