Medovations innerVision Manual Del Usuario página 2

Medovations InnerVision
Directions for Use and Cleaning. Read carefully prior to use.
CAUTION: Federal (U.S.A.) Law restricts this device to sale by or on the order of a physician.
FIGURE 1. INNERVISION TM TRANSILLUMINATION
SYSTEM*
DESCRIPTION
The Medovations InnerVision TM Transillumination
System is designed to aid in the identification of the
esophagus, rectum and other structures by transillumina-
tion during laparoscopy, thoracoscopy, or open proce-
dures. When used in the esophagus, the InnerVision
also be described as a lighted bougie.
The system consists of two (2) components:
1. InnerVision TM Fiber Optic Cable: Consists of a sili-
cone elastomer fiber optic cable with a built-in exten-
sion 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 pur-
chase. Used with a Circon-ACMI/Olympus cable.
2. InnerVision TM 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 TM Transillumination System can be used
with a Cogent light source, but an adapter must be ordered
from Cogent Light.
All contents of the InnerVision TM Transillumination
System are latex free.
DESCRIPTION OF SYMBOLS USED ON
LABELS
Non-Sterile Device
Caution, Consult Accompanying
Documents
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
INDICATIONS FOR USE
The InnerVision TM 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, thoracoscop-
ic 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 col-
orectal laparoscopic and open procedures.
CONTRAINDICATIONS
Use of the InnerVision TM System is contraindicated in sit-
uations where the size or presence of the device could
cause injury or contamination. The device is contraindi-
cated if the patient has a severe stricture or obstruction
which would not allow any size to be inserted. The devise
is contraindicated if the patient has known or suspected
intubation complications and/or difficulties. Use of the
TM
InnerVision System is contraindicated if resistance is
felt during insertion of this device.
TM
Transillumination System
COMPLICATIONS
• Inability to place the InnerVision
occur. It is possible that several strictures and obstruc-
tions may prevent insertion of the device. It is possi-
ble that a smaller InnerVision TM 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 pos-
sible to perforate tissues with the InnerVision
ed 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 transillumina-
TM can
tion of the esophagus.
W ARNINGS
1. The Fiber Optic Cable CANNOT be used on a patient
without the correctly sized Detachable Tip properly
connected, as a thermal injury will occur.
2. 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.
3. This device is NOT RECOMMENDED for use on
patients with known or suspected intubation compli-
cations and/or difficulties. Discontinue use if resist-
ance 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
tem from the patient, DO NOT ALLOW SHARP
BENDS. The Detachable Tips have become discon-
nected while in the body due to sharp bending.
5. As the InnerVision TM is removed from the esophagus,
the Detachable Tip must NOT be bent past 45 degrees
at the connector; thermal injury would then be possi-
ble 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 open-
ings 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 TM 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 disinfectant 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.
* U.S. Patents #5,624,432; 5,718,666; International Patents #0 568
656; 69225583.4; 659,870; Additional international patents pending.
1
TM System may
TM light-
TM sys-