Prior To Use - Medovations Innervision Mode D'emploi

3. Sterilize the Fiber Optic Cable using a steam autoclave 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 appropriate owner's manual should be followed. Medovations' validated gravity-type steam sterilization 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 equipment used at the user facility.
4. If sterilization is being done by steam autoclave, allow the Fiber Optic Cable to completely cool to room temperature (25
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 disinfectants 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 reused due to both the silicone elastomer absorbing the disinfectant
solutions and the small openings in the tip retaining some of the disinfectant 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 connector 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 incorrect adapter will
result in a lower level of illumination.
2. Inspect the Fiber Optic Cable for defects by the following 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
provide 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 mating connector tip of the cable (see Figure 3). DO NOT lubricate the connection between the Fiber Optic Cable & Detachable
Tip. 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 plugging the connector into the light source in the same manner 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 visible 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 lighted bougie is passed into the
esophagus typically by an anesthesiologist. The InnerVision 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
disconnected while in the body due to sharp bending.
4. 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.
5. When the surgical procedure or use of the bougie is completed, turn the light source off and disconnect the InnerVision System from the light
source. Hold the black finger grip and pull the connector away from the light source. Pulling on any other part of the cable will result in damage to
the fiber optics in the cable.
6. As the InnerVision is removed from the esophagus, the Detachable Tip must not be bent past 45 degrees at the connector; thermal injury would
then be possible through the sidewall of the tip.
7. To remove the Detachable Tip, grasp the tip near the proximal end of the Fiber Optic Cable. With hands close together, rotate the hand holding the
tip in a peeling motion (see Figure 4). Do not pull the tip horizontally as damage to the connector on the cable and damage to the fiber optics will
occur (see Figure 5). The Detachable Tip is discarded and the Fiber Optic Cable is cleaned and sterilized for future use.
UNCONTROLLED COPY
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C). Our testing indicated
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