Medovations innerVision Manual Del Usuario página 3

10. The Fiber Optic Cable cannot be used on a patient without
the Detachable Tip connected, as thermal injury will occur.
11. When using the Circon-ACMI light source, half of the
stainless steel connector on the Circon-ACMI Fiber Optic
Cable is still visible (1 inch section). Do not force the
cable into the Circon-ACMI/Olympus light source any
further than 1 inch. Do not touch the visible part of the
stainless steel connector on the cable, as it will cause ther-
mal injury.
12. When removing the Fiber Optic Cable from the light
source, hold the black grip to pull the cable. Pulling on any
other part of the cable will result in damage to the fiber
optics in the cable.
13. When inserting and removing the InnerVision TM System
from the patient, DO NOT ALLOW SHARP BENDS.
The Detachable Tips have become disconnected
while in the body due to sharp bending.
14. This device is NOT RECOMMENDED for use on
patients with known or suspected intubation complica-
tions and/or difficulties. Discontinue use if resistance is
felt during insertion of this device. Resistance may cause
the Detachable Tip to become separated from the Fiber
Optic Cable.
Fiber optic breakage can result in light and function loss.
Hold the tip connector of the Fiber Optic Cable towards a
regular light and examine the light source connector end of
the cable for broken fibers. Small black dots on the surface
of the glass fibers indicate broken fibers (see Figure 2). Do
not use the fiber optic light source for this test as the intense
light can cause eye damage. A damaged Fiber Optic Cable
must not be used and must be replaced.
Replace
Good Soon Replace
FIGURE 2. FIBER OPTIC CABLE REPLACEMENT
CHART
CLEANING & STERILIZING THE FIBER
OPTIC CABLE
1. Cleaning is recommended for new and used
TM
InnerVision Fiber Optic Cables prior to use. Clean
the cable thoroughly, immediately after use, with a
soft-bristle brush in lukewarm soapy water to remove
contaminants. Use a non-oily cleaner or mild non-
abrasive soap. Do not use synthetic detergents or oil-
based soaps as these may be absorbed by the cable
surface and may subsequently leach out and cause tis-
sue reaction.
2. Rinse thoroughly in lukewarm water. Follow with a
thorough rinse in distilled water.
3. Sterilize the Fiber Optic Cable using a steam auto-
clave or STERRAD® Sterilization System. Use the
"STERRAD®100 System Operator's Manual" when
sterilizing the Fiber Optic Cable with a STERRAD®
System. Whichever sterilization method is used, the
institutional protocols and instructions in the appro-
priate owner's manual should be followed.
Medovations' validated gravity-type steam steriliza-
tion settings are 132 degrees Celsius for a cycle time
of 15 minutes. Prevacuum steam sterilization settings
are 132 degrees Celsius for a cycle time of 4 minutes.
Cables sterilized by gravity-type or prevacuum steam
sterilization machines should be individually
wrapped. Medovations relies on the user to properly
validate the sterilization method selected and equip-
ment used at the user facility.
4. If sterilization is being done by steam autoclave, allow
the Fiber Optic Cable to completely cool to room tem-
perature (25 0 C). Our testing indicated that a cooling
time of 20 minutes at room temperature is required.
Do not immerse in cold liquids. Avoid contact with
the metal tips. Do not attempt to attach a Detachable
Tip until it is cooled to avoid burns to user and patient.
5. Do not use any solvent except isopropyl alcohol.
6. Do not soak in any solution including disinfectant
such as glutaraldehyde.
7. Do not use germicides such as bichloride of mercury
or other corrosive solutions.
8. Do not clean in an ultrasonic cleaning device.
9. Do not clean or sterilize the Detachable Tips.
Detachable Tips can not be reused due to both the silicone
elastomer absorbing the disinfectant solutions and the
small openings in the tip retaining some of the disin-
fectant solution, which subsequently would allow the
chemicals to leach out and cause tissue reaction in
patients.
PRIOR TO USE
1. Ensure that a functional 250-300 watt fiber optic light
source is available that will accommodate the connec-
tor on the Fiber Optic Cable. An additional adapter
will need to be used with a Wolf light source or a Cogent
light source. A lower-power light source or an incor-
rect adapter will result in a lower level of illumination.
2. Inspect the Fiber Optic Cable for defects by the fol-
lowing steps. Damaged cables must be discarded. A
backup cable should be available at time of use.
a. Examine the cable for cracks, splits, gouges,
and tears.
b. Examine the junction between the connector tips
and the cable for cracks, peeling, gaps or general
deterioration and loosening.
c. Hold the tip connector towards a regular light and
examine the light source adapter end of the Fiber
Optic Cable for broken fibers. Replace the cable
if too many fibers are broken (see Figure 2).
Damage to the fibers will reduce the amount of
light transmitted so that the bougie may not pro-
vide adequate illumination. If light transmission is
decreased, replace the Fiber Optic Cable.
3. Attach the Detachable Tip to the Fiber Optic Cable by
grasping the tip at the socket end and the cable at the
connector tip and pushing the tip socket onto the mat-
ing connector tip of the cable (see Figure 3). Do NOT
lubricate the metal connector of the Fiber Optic Cable
OR any part of the connection between the Fiber
Optic Cable & Detachable Tip. The outside of the
assembled System must be lubricated before
passage.The connector on the 40 Fr. tip is different from
the connector on the 50 Fr. and the 56 Fr.; however, the
tips are attached in exactly the same way. The Fiber
Optic Cable cannot be used on a patient without the
Detachable Tip connected, as thermal injury will occur.
FIGURE 3. ATTACHMENT OF THE DETACHABLE
TIP TO THE FIBER OPTIC CABLE.
4. Attach the Fiber Optic Cable to the light source by plug-
ging the connector into the light source in the same man-
ner as a standard light source extension cable. An adapter
needs to be attached to the Circon-ACMI/Olympus cable
before plugging into a Wolf/Dyonics light source or
Cogent light source. When using the Circon-ACMI light
source, half of the stainless steel connector on the Circon-
ACMI Fiber Optic Cable is still visible (1 inch section).
Do not force the cable into the Circon-ACMI/Olympus
light source any further than 1 inch. Do not touch the vis-
ible part of the stainless steel connector on the cable, as it
will cause thermal injury.
ESOPHAGEAL TRANSILLUMINATION
1. The patient is prepared for surgery and the surgical
procedure initiated. The tipped end of the
InnerVision TM lighted bougie is passed into the
esophagus typically by an anesthesiologist. The
InnerVision TM lighted bougie must be lubricated for
passage down the esophagus. Water, sterile saline or a
clear medical lubricating gel can be used to lubricate
the lighted bougie.
2. The light source is turned on when appropriate, but
always before passage of the bougie into the stomach.
3. When inserting and removing the InnerVision
System from the patient, DO NOT ALLOW SHARP
BENDS. The Detachable Tips have become discon-
nected while in the body due to sharp bending.
4. Discontinue use if the resistance if felt during inser-
tion of this device, Resistance may cause the
Detachable Tip to become separated from the Fiber
Optic Cable.
FIGURE 4. REMOVE THE DETACHABLE
TIP WITH A PEELING MOTION
2
TM