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SHIELS INTUSSUSCEPTION AIR REDUCTION SYSTEM PRECAUTIONS 1.
Do not use this pneumatic insufflation device with patients who
are in septic shock or have radiographic evidence of bowel perforation. 2.
Colonic decompression should be performed by use of the stopcock
handle only. Do not decompress the
colon by turning the circular air release valve on the insufflator / gauge
assembly. 3.
If using a pressure relief valve, forceful air delivery may cause
the unit to exceed selected pressure level. Insufflate with caution when
sustaining high pressures during pneumatic reduction. 4.
Always have an 18 gauge or larger needle immediately available for
peritoneal decompression in the event of bowel perforation. Caution: Federal
law restricts this device to sale on or by the order of a physician. Directions for Use Shiels Intussusception Air Reduction
System without pressure relief valve 1.
Prepare supplies which include air reduction tubing set,
insufflator / gauge assembly, lubricant and tape. To avoid accidental damage to
the pressure gauge, do not connect insufflator / gauge assembly until enema tip
is secured in the rectum. 2.
Place enema tip into the rectum and securely tape the buttocks.
The stopcock handle may be turned to the forward position to prevent
reflux of stool into the tubing set. If
stool should reflux into the tubing set, pump air forward to clear the tubing.
During normal use, stool will not permeate the filter, nor will it
interfere with proper filter function. 3.
Using the alignment dots and a clockwise turning motion, connect
the insufflator / gauge assembly to the tubing set.
Proper mounting will place the stopcock handle on the underside of the
assembled pneumatic reduction system. DO
NOT over-tighten the threaded mount, as this will result in suboptimal stopcock
handle placement. 4.
Before beginning colonic insufflation, check to be sure that the
stopcock handle is aligned with the sideport, thus insuring forward air flow for
insufflation. Check to insure that
the black circular air release valve is completely closed and that the gauge is
properly calibrated. The zero point
for the gauge needle should be over the small rectangular box at the 5.
A quick system check for air leaks can be completed by folding the
tubing closed while pumping a small amount of air.
If an air leak is encountered, recheck the stopcock handle and
insufflator / gauge air release valve for proper and secure positioning. 6.
The underside placement of the stopcock handle allows for one
–handed operation and fingertip control for colonic decompression.
The stopcock handle is precisely positioned so that the device can be
held and operated in either the right of left hand. During the enema, if the
monitored pressure exceeds the operator’s desired level, decompression is
instantly accomplished by pulling the stopcock handle backward in a trigger-like
fashion. The airtight stopcock, when
pulled back, will close the gauge, registering the intracolonic pressure at the
time of decompression. 7.
The device can be held at any level which facilitates simultaneous
viewing of the pressure gauge and fluoroscopic monitor. 8.
Upon completion of the air enema, if the radiologist desires to
add positive contrast media the enema tip need not be removed.
To convert to a positive contrast enema, simply cut the clear tubing
between the filter and enema tip, attach the “Christmas tree” step connector
(included in package) and connect the positive contrast tubing. 9.
Upon completion of the air enema, the entire tubing system should
be discarded. Do not attempt to
sterilize the tubing system for reuse. Directions for use with Pressure Relief Valve 1.
Follow all instructions for Shiels intussusception system without
relief valve. 2.
Attach the valve in between the stopcock and the insufflater /
gauge device. 3.
During the enema, if the intracolonic pressure rises to 120mm +/-
10%, the valve opens reducing the risk of unexpected pressure increase.
A hissing or whistling sound can be heard when the device opens. 4.
Remember: Although
this device is equipped with a pressure limiting device which opens
approximately at 120 mmHg forceful air delivery may cause the unit to exceed
this level. Use caution when
inflating the device and inflate slowly. 5.
After enema is complete, remove the entire tubing system retaining
the valve and insufflator / gauge. The tubing system is for single patient use
only. Note: This safety valve is for releasing
the pressure during intussusception procedures. The valve is a spring-loaded
system incorporated in the t-connector before the stopcock.
The valve is calibrated to open at 2.5 atm (129mmHG), + / - 10%.
This means the circuit could open anywhere in the range of 116 – 142
mmHG. Before performing the procedure it is recommended that you test the valve
by closing the stopcock to the circuit facing the inflator, and pumping the
inflator until you here a hiss. Most
clinicians agree that the maximum pressure for this procedure is 120mm HG when
the child is at rest. Therefore,
you must be vigilant of the pressure gauge as you pump air into this system.
Failure to do so could cause
perforation. The valve can be reused if desired, since
it is at the back end of the .22 micron filter on the kit. If you have any questions, do not hesitate
to contact GRI at 800-291-9425 or email snider@grimedical.com |