King Systems LT-D Instrucciones De Uso

KING LT(S)-D
Caution: Federal law restricts this device to
sale by or on the order of a physician.
DESCRIPTIONS
The KING LT(S)-D is a single use device
intended for airway management.
KING LT-D: Consists of a curved tube with
ventilation apertures located between two
inflatable cuffs. Both cuffs are inflated using
a single valve / pilot balloon. The distal cuff is
designed to seal the esophagus, while the
proximal cuff is intended to seal the
oropharynx. Attached to the proximal end of
the tube is a 15 mm connector for
attachment to a standard breathing circuit or
resuscitation bag.
KING LTS-D: Consists of a curved double-
lumen tube with separate pathways for
ventilation and access to the stomach. The
ventilation lumen ends between the two
inflatable cuffs with a variety of openings
intended to align with the laryngeal inlet.
Attached to the proximal end of the
ventilation lumen is a 15 mm connector for
attachment to a standard breathing circuit or
resuscitation bag. The gastric access lumen is
a separate conduit that allows passage of up
to an 18 Fr standard gastric tube from its
external proximal opening to the distal tip of
the KING LTS-D, which is intended to be
positioned in the upper esophagus. This
allows the gastric tube to be easily inserted
into the stomach for removal of fluids. In the
absence of a gastric tube, the gastric access
lumen allows channeling of gases and fluids
from the esophagus and stomach to a point
outside the patient's mouth.
The KING LT(S)-D stand-alone product is
provided sterile (sterilization is by ethylene
oxide). The KING LT(S)-D Kit is provided non-
sterile. Sterilization is indicated on packaging.
Single Valve / Pilot Balloon:
Inflates both cuffs.
Orientation / X-ray Line
Ventilatory Openings:
In front of the larynx
for efficient ventilation
Proximal Cuff:
and allows passage
Stabilizes
of fiberoptic
tube and seals
bronchoscope
the oropharynx.
or tube
exchange
catheter.
Bi-lateral Eyes:
Additional eyelets
to supplement
ventilation.
Distal Cuff: Blocks entry of esophagus.
Reduces the possibility of gastric
insufflation.
Distal Opening of Gastric Access Lumen
(KING LTS-D only)
KING LT-D
Distal cuff
INDICATIONS FOR USE
The KING LT(S)-D is indicated for airway
management by providing a patent airway to
allow patient ventilation.
TM Airway - INSTRUCTIONS FOR USE
Proximal Cuff
Inflates at the
base of the
tongue.
Isolates the
laryngopharynx
from the
oropharynx and
nasopharynx.
Distal Cuff
Inflates in the esophagus. Isolates the
laryngopharynx from the esophagus.
CONTRAINDICATIONS
The following contraindications are applicable
for routine use of the KING LT(S)-D:
• Responsive patients with an intact gag
reflex.
• Patients with known esophageal disease.
• Patients who have ingested caustic
substances.
• The KING LT(S)-D is not proven to
protect the airway from the effects of
regurgitation and aspiration. The risk of
regurgitation and aspiration must be
weighed against the potential benefit of
establishing an airway.
WARNINGS/PRECAUTIONS
• High airway pressures may divert gas
to the atmosphere (or stomach with
KING LT-D).
• Intubation of the trachea cannot be
ruled out as a potential complication of
the insertion of the KING LT(S)-D.
• After placement, perform standard
checks for breath sounds and utilize an
appropriate carbon dioxide monitor as
required by protocol.
• Lubricate only the posterior surface of
the KING LT(S)-D to avoid blockage of
the ventilation apertures or aspiration
of the lubricant.
• The KING LT(S)-D is not intended for
re-use.
Proximal
During transition to spontaneous
Opening of
ventilation, airway manipulations or
Gastric Access
other methods may be needed to maintain
Lumen: Allows
airway patency.
passage of 18 Fr
gastric tube
(KING LTS-D
only).
Item Size 2
cm Depth
KLTD KLTD202 KLTD2025 KLTD203
Markings
KLTD Kit KLTD212 KLTD2125 KLTD213
KLTSD n/a
KLTSD Kit n/a
KLT(S)D kit is non-sterile and contains a KING LT(S)-D, syringe for cuff
inflation, lubricant, and abbreviated instructions for use.
Size Product
2 KLTD
2.5 KLTD
KLTD
3
KLTSD
KLTD
4
KLTSD
KLTD
5
KLTSD
KING LTS-D: For size 3, 4, and 5 the OD is 18 mm and the ID of the
Ventilation Lumen is equivalent to 10 mm. Gastric Tube Size <18 Fr
LATEX-FREE
The KING LT(S)-D is 100% latex-free and
should be considered safe to use on patients
who are latex sensitive.
ENGLISH
PRODUCT INFORMATION
Size 2.5 Size 3 Size 4 Size 5
KLTD204 KLTD205
KLTD214 KLTD215
n/a KLTSD403 KLTSD404 KLTSD405
n/a KLTSD413 KLTSD414 KLTSD415
SIZING INFORMATION
Patient Connector Inflation
Criteria Color Volumes
35-45 in
Green 25-35 ml
(90-115 cm)
41-51 in
Orange 30-40 ml
(105-130 cm)
45-60 ml
4-5 ft
Yellow
(122-155 cm)
40-55 ml
60-80 ml
5-6 ft
Red
(155-180 cm)
50-70 ml
70-90 ml
greater than 6 ft
Purple
(>180 cm) 60-80 ml
KING LT(S)-D INSERTION INSTRUCTIONS
1. Using the information provided, choose
the correct KING LT(S)-D size, based on
patient height.
2. Test cuff inflation system by injecting
the maximum recommended volume of
air into the cuffs (refer to Sizing
Information chart). Remove all air from
cuffs prior to insertion.
3. Apply a water-based lubricant to the
beveled distal tip and posterior aspect of
the tube, taking care to avoid
introduction of lubricant in or near the
ventilatory openings.
4. Have a spare KING LT(S)-D ready and
prepared for immediate use.
5. Pre-oxygenate.
6. Achieve the appropriate depth of
anesthesia. (An adequate level of
anesthesia is required before attempting
insertion of the KING LT(S)-D. Standard
monitoring techniques should be
followed when inducing anesthesia. In
general, the depth of anesthesia needed
is a little more than that required for the
insertion of a Guedel-type airway. It is
recommended that the less experienced
user choose a slightly deeper level of
anesthesia.)
7. Position the head. The ideal head
position for insertion of the KING LT(S)-D
is the "sniffing position". However, the
angle and shortness of the tube also
allows it to be inserted with the head in a
neutral position.
8. Hold the KING LT(S)-D at the connector
with dominant hand. With non-
dominant hand, hold mouth open and
apply chin lift unless contraindicated by
C-spine precautions or patient position.
9. With the KING
LT(S)-D rotated
laterally 45-90º
such that the
blue orientation
line is touching
the corner of the mouth, introduce tip
into mouth and advance behind base of
tongue. Never force the tube into
position.
10. As tube
tip
passes
under
tongue,
rotate
tube back
to midline (blue orientation line faces
chin).
11. Without exerting
excessive force,
advance KING LT(S)-D
until base of connector
aligns with teeth or
gums.
12 Using the KLT 900 Cuff
Pressure Gauge, inflate cuffs
of the KING LT(S)-D to 60
cm H 2 O. If the KLT 900 Cuff
Pressure Gauge is not
available and
a syringe is being used to
inflate the KING LT(S)-D, inflate cuffs
with the minimum volume necessary to
seal the airway at the peak ventilatory
pressure employed (just seal volume).
13. Attach the breathing circuit or
resuscitator bag to the 15 mm connector
of the KING LT(S)-D. While gently
bagging the patient to assess ventilation,