Indications For Use; Contraindications - Medovations Innervision Mode D'emploi

CAUTION: Federal (U.S.A.) Law restricts this device to sale by or on the order of a physician.
U.S. Patents #5,624,432; 5,718,666;
International Patents #0 568 656; 69225583.4; 659,870;
Additional international patents pending.
FIGURE 1. INNERVISION TRANSILLUMINATION SYSTEM
DESCRIPTION
The Medovations InnerVision Transillumination System is designed to aid in the identification of the esophagus, rectum and other structures by
transillumination during laparoscopy, thoracoscopy, or open procedures. When used in the esophagus, the InnerVision can also be described as a
lighted bougie.
The system consists of two (2) components:
1. InnerVision Fiber Optic Cable: Consists of a silicone elastomer fiber optic cable with a built-in extension cable, having a stainless steel tip connector
at one end and a light source connector at the other end. Provided non-sterile. Reusable. Packaged one (1) cable per box.

Available in 40 French, 50 French, and 56 French sizes

Available with a Circon-ACMI/Olympus light source connector, or

Available with a Storz light source connector

Wolf/Dyonics light source adapter available for purchase. Used with a Circon-ACMI/Olympus cable.
2. InnerVision Detachable Tip: Clear, flexible silicone tip that fits on the tip of the Fiber Optic Cable. Sterile, single use only. Packaged five (5) tips per
box.

Available in 40 French, 50 French, and 56 French sizes
InnerVision Transillumination System can be used with a Cogent light source, but an adapter must be ordered from Cogent Light.
All contents of the InnerVision Transillumination System are not made with natural rubber latex.
DESCRIPTION OF SYMBOLS USED ON LABELS
Caution, Consult Accompanying Documents

INDICATIONS FOR USE

The InnerVision Transillumination System is intended for use:
1. To transilluminate the esophagus and assist in the identification and location of the esophagus and its surrounding tissues during laparoscopic,
thoracoscopic and open procedures.
2. To transilluminate the rectum and rectosigmoid and assist in the identification and location of these and the surrounding tissues during
gynecological and colorectal laparoscopic and open procedures.

CONTRAINDICATIONS

Use of the InnerVision System is contraindicated in situations where the size or presence of the device could cause injury or contamination. The device
is contraindicated if the patient has a severe stricture or obstruction which would not allow any size to be inserted. The device is contraindicated if the
Meodvations Innervision® Transillumination System
Instructions for Use and Cleaning.
Read carefully prior to use.
Non-Sterile Device
Fragile, Handle with Care
Consult Operating Instructions
Do Not Re-Use
Do Not Use if Package is Damaged
Do Not Re-Sterilize
Sterilized Using Ethylene Oxide
UNCONTROLLED COPY
2