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6. Careful handling is essential. Avoid contact with sharp or pointed objects at all
times to prevent tearing or perforation of the device. Do not insert the device
unless the cuffs are fully deflated as described in the instructions for insertion.
7. Gloves should be worn during preparation and insertion to minimize
contamination of the airway.
8. Used device shall follow a handling and elimination process for bio-hazard
products, in accordance with all local and national regulations.
9. Store the device in a dark cool environment, avoiding direct sunlight or
extremes of temperatures.
10. Ensure all removable denture work is removed before inserting the device.
11. An unreliable or obstructed airway may result in cases where the device has
been incorrectly inserted.
PREPARATION FOR USE:
Choose the correct size of device. Refer to Table 1 for patient weight and size
information.
Keep a clearly marked syringe for inflation and deflation of the cuff.
PRE-USE CHECKS:
Warning: It is most important that pre-use checks are carried out on the device
prior to use, in order to establish whether it is safe for use.
Warning: Failure of any one test indicates the device should not be used.
These tests should be carried out as follows:
1. Examine the interior of the airway tube to ensure it is free from blockage or
loose particles. Examine the tube throughout its length. Should any cuts or
indentations be found, discard the device.
2. Holding at each end flex the airway tube to increase its curvature up to but not
o
beyond 180
. Should the tube kink during this procedure, discard the device.
3. Deflate the cuff fully.
For LMA
Unique™ (S)
Re-inflate the device with a volume of air 50% greater than the maximum inflation
value for each size.
Table 4: Test cuff over-inflation volumes
1
1.5
2
Over-
inflation
cuff
6
10
15
volumes
(ml)
Examine the cuff for leaks, herniations and uneven bulging. If any indications of
these problems exist, discard the device. A herniating mask may cause obstruction
during use.
While the device remains 50% over-inflated, examine the inflation pilot balloon.
The balloon shape should be elliptical, not spherical. Then, deflate the mask again.
For LMA
Unique™ (S) Cuff Pilot™
Re-inflate the device to Red Zone of Cuff Pilot™ (Fig 14) with a volume of air >
70cmH
0.
2
Examine the cuff for leaks, herniations and uneven bulging. If any indications of
these problems exist, discard the device. A herniating mask may cause obstruction
during use. Then, deflate the mask again.
4. Examine the airway connector. It should fit securely into the airway tube and it
should not be possible using reasonable force, to remove. Do not use excessive
force or twist the connector as this may break the seal. If the connector is loose,
discard the device to avoid the risk of accidental disconnection during use.
5. Discoloration. Discoloration affects visibility of fluid in the airway tube.
6. Gently pull the inflation line to ensure it is securely attached to both the cuff
and balloon.
7. Examine the aperture in the mask. Gently probe the two flexible bars
traversing the mask aperture to ensure they are not broken or otherwise damaged.
If the aperture bars are not intact, the epiglottis may obstruct the airway. Do not
.
use if the aperture bar is damaged
PRE-INSERTION PREPARATION:
Deflate the cuff completely in order to create the stiff thin leading edge necessary
to wedge the tip behind the cricoid cartilage. The cuff should fold back away from
the aperture bars. Lubricate the back of the cuff thoroughly just before insertion.
Do not lubricate the front as this may result in blockage of aperture bar or
aspiration of lubricant.
Warning: A water-soluble lubricant, such as K-Y Jelly®, should be used. Do not use
silicone-based lubricants as they degrade the device components. Lubricants
containing Lidocaine are not recommended for use with the device. Lidocaine can
delay the return of the patient's protective reflexes expected prior to removal of
Device Size
2.5
3
4
5
21
30
45
60
the device, may possibly provoke an allergic reaction, or may affect the
surrounding structures, including the vocal cords.
Caution: Ensure all removable denture work is removed before inserting the
device.
INSERTION:
Caution: Gloves should be worn during preparation and insertion to minimize
contamination of the airway.
Caution: The patency of this device should be reconfirmed after any change in the
patient's head or neck position.
Standard Insertion Method:
1. Anaesthesia must be deep enough to permit insertion.
Do not try to insert immediately following barbiturate induction, unless a relaxant
drug has been given.
2. Position the head and neck as for normal tracheal intubation.
Keep the neck flexed and the head extended by pushing the head from behind
with one hand while inserting the mask into the mouth with the other hand (Fig.4).
3. When inserting the mask, hold it like a pen with the index finger placed
anteriorly at the junction of the cuff and tube (Fig.4). Press the tip up against the
hard palate and verify it lies flat against the palate and that the tip is not folded
over, before pushing further into the pharynx.
4. Using the index finger, push the mask backwards still maintaining pressure
against the palate (Fig.5).
5. As the mask moves downwards, the index finger maintains pressure backwards
against the posterior pharyngeal wall to avoid collision with the epiglottis. Insert
the index finger fully into the mouth to complete insertion (Fig.6). Keep other
fingers out of the mouth. As insertion progresses, the flexor surface of the whole
index finger should lie along the tube, keeping it firmly in contact with the palate.
(Fig.6).
AVOID INSERTING WITH SEVERAL MOVEMENTS OR JERKING UP AND DOWN IN
THE PHARYNX AFTER RESISTANCE IS FELT.
When resistance is felt the finger should already have been fully inserted into the
mouth. Use the other hand to hold the tube while withdrawing the finger from the
mouth (Fig.7).
6
6. Check that the black dotted line on the tube faces the upper lip.
Now immediately inflate the cuff without holding the tube.
Do this BEFORE connection to the gas supply. This will permit the device to
75
position itself correctly. Inflate the cuff with sufficient air to obtain a low pressure
seal. Refer to Table 5 for inflation information. During cuff inflation, do not hold
the tube as this prevents the device from settling into its correct location.
Warning: NEVER OVERINFLATE THE CUFF.
Table 5: Inflation Information
Product
Recommended
LMA
Maximum Cuff
inflation
Unique™
volume
(S)
(ml/60cmH
LMA
Uniq
Intracuff
ue™ (S)
pressure
Cuff Pilot™
(cmH
O)
2
7. Connect to the gas supply, holding the tube, to prevent displacement. Gently
inflate the lungs to confirm correct placement. Insert a roll of gauze as a bite-block
(ensuring adequate thickness), and tape the device into place, ensuring that the
proximal end of the airway tube is pointing caudally. When correctly placed, the
tube should be pressed back into the palate and posterior pharyngeal wall. When
using the device, it is important to remember to insert a bite block at the end of
the insertion procedure.
Figure 4
Figure 6
Page 3 of 5
Device Size
1
1.5
2
2.5
4
7
10
14
0)
2
60
60
60
60
Figure 5
Figure 7
3
4
5
6
20
30
40
50
60
60
60
60
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