Precautions - Hologic Aquilex Fluid Control System Instrucciones De Uso Y Manual Del Operador

WARNING!
Hypothermia (monitoring body temperature)
Continuous flow of distention fluids can lead to a lowering of the patient's body
temperature during hysteroscopic surgery. Lower body temperatures can cause
coronary and cardiovascular problems. Always monitor the patient's body temper-
ature during the entire surgery. Make especially sure that the following, hypother-
mia promoting, operation conditions are avoided as best as possible:
• longer operating times
• use of cold irrigation fluid.
WARNING!
Rupture of the fallopian tube secondary to tubal obstruction
Distention of the uterus may lead to a tear of the fallopian tube should there be an
obstruction or permanent occlusion. The rupture could lead to irrigation fluid flow-
ing into the patient's peritoneal cavity, resulting in a fluid overload. It is critical to
closely monitor the input and outflow of the distending liquid at all times.
WARNING!
Air embolism
An air embolism can be the result of air contained in the tube set or connected in-
strument reaching the patient. Ensure there is always fluid in the bag to prevent air
from being pumped into the patient.
WARNING!
Hysteroscope
The system may only be connected with hysteroscopes designed for and featuring
the technical specification permitting such a combined use. Any utilized hystero-
scopes must comply with the most recent versions of IEC 60601-2-18 and ISO 8600.

3.1.3 Precautions

CAUTION!
Federal Law (only for U.S. market)
Federal law restricts this device to sale by or on the order of a physician.
CAUTION!
Indoor climate
Before switching on the device, sufficient time must have passed to adjust to the
indoor climate.
CAUTION!
Instrument recognition
The instrument recognition must be performed outside and at the level of the pa-
tient.
Purpose
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