Medovations Innervision Mode D'emploi page 3

patient has known or suspected intubation complications and/or difficulties. Use of the InnerVision System is contraindicated if resistance is felt during
insertion of this device.
COMPLICATIONS

Inability to place the InnerVision System may occur. It is possible that several strictures and obstructions may prevent insertion of the device. It is
possible that a smaller InnerVision System may be inserted more easily. This device should not be used if resistance is felt during insertion of the
device.

It has been reported that non-illuminated bougies have perforated the walls of the esophagus. It may be possible to perforate tissues with the
InnerVision lighted bougie.

Active severe inflammation may interfere with the passage of the larger devices and may require the use of device with a smaller diameter.

Active bleeding may interfere with the transillumination of the esophagus.
WARNINGS
1. The Fiber Optic Cable CANNOT be used on a patient without the correctly sized Detachable Tip properly connected, as thermal injury will occur.
2. Do NOT lubricate the connection between the Fiber Optic Cable & Detachable Tip.
3. This device is NOT RECOMMENDED for use on patients with known or suspected intubation complications 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.
4. 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.
5. 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.
PRECAUTION
The Detachable Tips are sterile and single use only. Dispose the tip after use. DO NOT REUSE. 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 disinfectant solution, which subsequently
would allow the chemicals to leach out and cause tissue reaction in patients.
A damaged Detachable Tip must not be used. Using a damaged Detachable tip could result in unintentional detachment of the tip or exposure of the
patient to the fiber optic bundle with the possible result of injury to the patient.
The Fiber Optic Cable is a delicate device. Meticulous care must be taken to prevent damage from occurring. The cable must be handled and cleaned
carefully. Improper maintenance will not only affect the function of the Medovations InnerVision Transillumination System, but can also cause harm to
the patient. Any damage will render the cable unusable. A damaged Fiber Optic Cable must not be used and must be replaced.
1. Avoid contact with any sharp edges or pointed objects. Any cut or puncture can expose the optical fibers.
2. Do not use any solvent except isopropyl alcohol.
3. Do not soak in any solution including disinfectants such as glutaraldehyde.
4. Do not use germicides such as bichloride of mercury or other corrosive solutions.
5. Do not clean in an ultrasonic cleaning device.
6. Do not use clamps or forceps on the Fiber Optic Cable or Detachable Tips.
7. Do not twist, stretch, kink, squeeze, scratch or shake the Fiber Optic Cable. Do not pull, tightly coil or severely bend the cable as irreversibly
damage to the glass fibers will occur.
8. Take care in preventing any scratching from occurring on the face of glass fibers at the connector or adapter ends of the Fiber Optic Cable.
9. Cracking, discoloration, and broken fibers are the most obvious indications of aging and will affect the safety and effectiveness of the cable.
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 thermal 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 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 complications 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.
Good Replace
Soon
FIGURE 2. FIBER OPTIC CABLE REPLACEMENT CHART
CLEANING & STERILIZING THE FIBER OPTIC CABLE
1. Cleaning is recommended for new and used 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 tissue reaction.
2. Rinse thoroughly in lukewarm water. Follow with a thorough rinse in distilled water.
Replace
UNCONTROLLED COPY
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