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should be removed. Do not use the airway if the blockage or
particle cannot be removed.
• Deflate the cuff completely. Once deflated, check the cuff for
spontaneous inflation. Do not use the airway if the cuff
spontaneously inflates.
9. DEFLATING THE DEVICE PRIOR TO INSERTION
- After firmly connecting a syringe of at least 50ml to the inflation port,
hold the syringe and the LMA Supreme™ exactly as shown in figure 4.
Move the connected syringe away from the device until the inflation
line is slightly stretched as shown. Compress the distal end of the
device in between the index finger and thumb while withdrawing air
until a vacuum has been obtained.
- While deflating, hold the device so that the distal end is curled slightly
anteriorly as shown in Figure 4
- Deflate the device until the tension in the syringe indicates a vacuum
has been created in the mask. Keep the syringe under tension while
rapidly disconnecting it from the inflation port. This will ensure the
mask remains correctly deflated, as shown in Fig 5.
Figure 4: LMA Supreme™ deflation
Figure 5: After achieving wedge
shape cuff during deflation,
disconnect the syringe from the
inflation line
10. INSERTION
- Lubricate the posterior surface of the mask and airway tube just prior
to insertion.
- Stand behind or beside patient's head.
- Place the head in the neutral or slight "sniffing" position (Sniffing =
extension of head + flexion of neck).
- Hold the device exactly as shown in figure 6.
- Press the distal tip against the inner aspect of the upper teeth or
gums.
- Slide inwards using a slightly diagonal approach (direct the tip away
from the mid-line).
- Continue to slide inwards rotating the hand in a circular motion so
that the device follows the curvature behind the tongue.
- Resistance should be felt when the distal end of the device meets the
upper esophageal sphincter. The device is now fully inserted
Figure 6: Press the tip of the
Figure 7: Press the cuff further
mask against the hard palate.
into the mouth, maintaining
pressure against the
Figure 8: Swing the device inward
Figure 9: Advance the device
with a circular motion, pressing
into the hypopharynx until
against the contours of the hard
resistance is felt.
and the soft palate.
11. FIXATION
Secure the LMA Supreme™ to patient's face using adhesive tape as
follows:
- Use a piece of adhesive tape 30-40cm long, holding it horizontally by
both ends.
- Press the adhesive tape transversely across the fixation tab,
continuing to press downwards so that the ends of the tape adhere
to each of the patient's cheeks and the device itself is gently pressed
inwards by the tape.
- Do not rotate the tape around the proximal end of the device.
- Do not use a Guedel airway; the device has an integral bite block.
Figure 10a
Figure 10b
Figure 10: Fix the device in place using adhesive tape. Stretching the
adhesive tape vertically downwards (See Figure 10a) ensures that the
middle of the tape is pressed vertically downwards over the tab as
shown in Figure 10b.
12. INFLATION
Inflate the cuff with air until the appropriate intra-cuff pressure is
reached. The recommended intra-cuff pressure should never exceed
60cm H₂O. If no manometer is by hand, inflate with just enough air to
achieve a seal sufficient to permit ventilation without leaks.
Airway
Patient
Max
Size
Weight
Size OG
Tube
1
< 5kg
6Fr
1.5
5-10kg
6Fr
2
10-20kg
10Fr
2.5
20-30kg
10Fr
3
30-50kg
14Fr
4
50-70kg
14Fr
5
70-100kg
14Fr
Table 1: LMA Supreme™ selection guide
13. CORRECT POSITION
Correct placement should produce a leak-free seal against the glottis
with the mask tip at the upper esophageal sphincter. The integral bite
block should lie between the teeth.
To facilitate diagnosis of correct mask placement, place a small bolus
(1-2ml) of suitably viscous water soluble lubricant in the proximal end
of the drain tube. In a properly placed mask, there should be a slight
up-down meniscus movement of the lubricant following the
application and release of gentle pressure on the suprasternal notch.
This indicates that the distal end of the drain tube is correctly placed so
that it seals around the upper esophageal sphincter (the 'suprasternal
notch test'). A similar movement may also be seen when gentle manual
positive pressure is applied to the airway through the device.
14. GASTRIC DRAINAGE
The drain tube facilitates channeling of fluids and gases emerging from
the stomach. To facilitate gastric drainage, a gastric tube may be
passed through the drain tube into the stomach at any time during the
anesthetic procedure. Refer to Table 1 for maximum gastric tube sizes.
The gastric tube should be well lubricated and passed slowly and
carefully. Suction should not be performed until the gastric tube has
reached the stomach. Suction should not be applied directly to the end
of the drain tube, as this may cause the drain tube to collapse and
might theoretically cause injury to the upper esophageal sphincter.
15. ANESTHESIA MAINTENANCE
The LMA Supreme™ is well tolerated in spontaneously breathing
patients when used with volatile agents or intravenous anesthesia,
provided anesthesia is adequate to match the level of surgical stimulus
and the cuff is not over-inflated.
During PPV using the LMA Supreme™ tidal volumes should not exceed
8ml/kg and peak inspiratory pressures should be kept below the
maximum airway seal pressure.
If leaks occur during PPV, this may be due to light anaesthesia causing a
degree of glottic closure, severe reduction in lung compliance related
to the procedure or patient factors or displacement or migration of the
cuff by head turning or traction in an inadequately fixed mask.
16. RECOVERY
Removal should always be carried out by trained personnel. Although
the device may not be removed in the operating theatre, its low
invasivity makes it a good device to maintain the airway during
recovery in the Post Anesthetic Care Unit (PACU) provided staff are
appropriately trained and equipped. Because recovery involves
palate.
increase in pharyngeal tone, it makes sense to reduce the volume of air
in the cuff before sending the patient to the PACU; however, the cuff
must never be fully deflated at this point.
Fully deflate the cuff and simultaneously remove the device ONLY
when the patient can open the mouth on command. If the cuff is FULLY
deflated before the return of effective swallowing and cough reflexes,
secretions in the upper pharynx may enter the larynx, provoking
coughing or laryngeal spasm.
Patient monitoring should continue throughout the recovery stage.
Where appropriate, oxygen may be continuously administered through
the anaesthetic circuit or via a T-piece attached to the proximal end of
the airway device.
17. USE WITH MAGNETIC RESONANCE IMAGING (MRI)
Testing has been performed to determine the compatibility of LMA
Supreme™ with MRI. Prior to using LMA Supreme™ in this environment,
the user should carefully compare the equipment and test conditions
described with those planned for use in the actual clinical environment.
Refer to the below for detailed results of device testing in the MRI
environment.
The LMA Supreme™ was determined to be MR-conditional. Non-
clinical testing demonstrated that the LMA Supreme™ is MR
Conditional. A patient with this device can be scanned safely
immediately after placement under the following conditions:
Static Magnetic Field
-Static magnetic field of 3-Tesla or less
-Maximum spatial gradient magnetic field of 720-Gauss/cm or less
MRI-Related Heating
In non-clinical testing, the device produced the following temperature
rise during MRI performed for 15-min of scanning (i.e., per pulse
sequence) in the 3-Tesla (3-Tesla/128-MHz, Excite, HDx, Software
14X.M5, General Electric Healthcare, Milwaukee, WI) MR system:
Highest temperature change +1.6°C
Therefore, the MRI-related heating experiments for the device at 3-
Tesla using a transmit/receive RF body coil at an MR system reported
whole body averaged SAR of 2.9 -W/kg (i.e., associated with a
calorimetry measured whole body averaged value of 2.7-W/kg)
indicated that the greatest amount of heating that occurred in
association with these specific conditions was equal to or less than
+1.6°C.
Recommended
Optimum
Maximum
Intra-Cuff
Inflation
Pressure
Volume
5 ml
8ml
12 ml
20ml
60cm H₂O
30 ml
45 ml
45 ml
Page 2 of 3
Artifact Information
MR image quality may be compromised if the area of interest is in the
exact same area or relatively close to the position of the device.
Therefore, optimization of MR imaging parameters to compensate for
the presence of this device may be necessary.
Pulse
T1-SE
T1-SE
Sequence
Signal Void
5,481-
12,343-
2
3,400-mm
2
Size
mm
mm
Plane
Parallel
Perpendicular
Orientation
18. SYMBOLS DEFINITION
Manufacturer
Authorized representative in the
European Community
Consult IFU on this website:
www.LMACO.com
Air inflation volume
Patient weight
Read Instruction before use
Not made with natural rubber latex
Fragile, handle with care
Keep away from sunlight
Keep dry
This way up
Product Code
Lot Number
CE Mark
Do not Re-use
Contains or Presence of Phthalates:
Bis(2-ethylhexyl) phthalate (DEHP)
Sterilized by Ethylene Oxide
Use By
Do not use if package is damaged
GRE
GRE
2
7,394-mm
2
Parallel
Perpendicular
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