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7. A continuous outflow of irrigation from the body cavity (operative site) is necessary to prevent
excessive pressure buildup.
8. Never attempt to service the device when it is connected to a power source. Hazardous voltages
inside the device may cause severe electrical shock. Disconnect the power cord before servicing.
9. As a Type BF applied part, this instrument must never be applied directly to the heart and must
not be used in procedures involving cardiac observation or surgery. Do not use electrically active
devices, such as electrosurgical units, on the patient during lithotripsy.
10. The housing of the generator must be properly grounded to ensure safe operation. To reduce the
risk of electric shock, be sure to connect the power cord to a properly grounded 3-pin receptacle.
Do not use a 3-pin /2-pin adapter.
11. The receptacle to which this product is connected should have enough power capacity to fulfill
the total power requirements of all equipment connected to it. If the capacity is insufficient,
the circuit breaker of the medical facility may be tripped, cutting off the power supply to all
equipment connected to the same power source.
12. To minimize the risk of electric shock and generator damage, keep all liquids away from the
generator. If liquid is spilled into this product, immediately stop the procedure and contact Gyrus
ACMI. If the power cord gets wet, fully dry it before use. Otherwise the user may receive an
electric shock.
13. This product is provided with air vents for heat release on the rear panel and bottom. Do not
block the air vents.
14. This product is a precision device; handle it with care. Avoid rough or violent handling, which
may cause equipment damage.
15. If you suspect any abnormality while using this product, immediately stop the procedure, and if
the trouble persists, contact Gyrus ACMI.
16. Keep the tip of probe in the field of view at all times when the CyberWand system is being used.
17. This equipment has been tested and found to comply with the EMC limits for the Medical Device
(EN55011 Class A and EN 60601-1-2 2004). The limits are designed to provide reasonable
protection against harmful interference in a typical medical installation. The equipment generates
and can radiate radio frequency energy and, if not installed and used in accordance with these
instructions, may cause harmful interference to other devices in the vicinity. However, there is no
guarantee that interference will not occur in a particular installation. If this equipment does cause
harmful interference with another device, which can be determined by turning the equipment off
and on, the user is encouraged to try to correct the interference by one or more of the following
methods:
a. Reorient or relocate the receiving device.
b. Increase the separation between instruments.
c. Connect the equipment into an outlet on a circuit different from that to which the other
devices are connected.
d. Consult the manufacturer or field service technician for help.
18. As with any lithotripter device, adverse events may occur, such as, bleeding and/or damage in
the kidney, and other potential events associated with endoscopy.
19. If a probe breaks during a procedure, use a grasping device to remove it. Always maintain a
spare probe set to finish the procedure.
