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Table 1: Specification for the device
1
1.5
Patient
Up
Weight
5-10
to 5
(kg)
Airway
Connector
Inflation
Valve
Internal
Volume of
ventilator
4
5
pathway
(ml)
Pressure
< 2.7
< 1.1
drop
cm
cm
(cm H
O
H
O
H
O
2
2
2
at l/min)
at 15
at 15
l/min
l/min
l/min
Min.
interdental
16
18
gap (mm)
Normal
length of
the
internal
10.5
12.0
ventilatory
pathway
(cm)
A summary of the methods, materials, data and results of clinical studies that
validate the requirements of this international standard is available on request, if
applicable.
Figure 3: Correct Position of the device in relation to anatomical landmarks
Table 2: Description of anatomical landmarks
Anatomical Landmarks
1 - Esophagus
2 - Trachea
3 - Cricoid cartilage
4 - Thyroid cartilage
5 - Laryngeal inlet
6 - Epiglottis
Table 3: Description of the device parts
a - Patient end
b - Ventilatory opening
c - Sealing mechanism
INDICATION FOR USE:
LMA
Unique™ (S) and LMA
achieving and maintaining control of the airway during routine and emergency
anaesthetic procedures in fasted patients using either spontaneous or Positive
Pressure Ventilation (PPV).
They are also indicated for securing the immediate airway in known or unexpected
difficult airway situations.
They are best suited for use in elective surgical procedures where tracheal
intubation is not necessary.
They may be used to establish an immediate, clear airway during cardiopulmonary
resuscitation (CPR) in the profoundly unconscious patient with absent
glossopharyngeal and laryngeal reflexes requiring artificial ventilation. In these
cases, the devices should be used only when tracheal intubation is not possible.
Device Size
2
2.5
3
4
10-
20-
30-
50-
20
30
50
70
15 mm male (ISO 5356-1)
Luer cone (ISO 594-1)
7
11
18
18
< 2.1
< 1.0
< 1.6
< 1.6
cm
cm
cm
cm
H
O
H
O
H
O
H
O
2
2
2
2
at 30
at 30
at 60
at 60
l/min
l/min
l/min
21
24
25
30
13.8
15.0
19.5
19.5
7 - Hyoid bone
8 - Tongue
9 - Buccal cavity
10 - Nasopharynx
11 - Incisors
d - Ventilatory pathway
e - External end connector
Unique™ (S) Cuff Pilot™ are indicated for use in
RISK-BENEFIT INFORMATION:
5
6
When used in the profoundly unresponsive patient in need of resuscitation or in a
difficult airway patient on an emergency pathway (i.e., "cannot intubate, cannot
70-
>100
ventilate"), the risk of regurgitation and aspiration must be weighed against the
100
potential benefit of establishing an airway.
CONTRAINDICATIONS:
Due to the potential risk of regurgitation and aspiration, do not use LMA®
Unique™ (S) and LMA® Unique™ (S) Cuff Pilot™ as a substitute for an endotracheal
tube in the following elective or difficult airway patients on a non-emergency
pathway:
1. Patients who have not fasted, including patients whose fasting cannot be
25
28
confirmed.
2. Patients who are grossly or morbidly obese, more than 14 weeks pregnant or
emergency and resuscitation situations or any condition associated with delayed
< 1.0
< 1.0
gastric emptying, or using opiate medication prior to fasting.
cm
cm
H
O
H
O
The device is also contraindicated in:
2
2
at 60
at 60
3. Patients with fixed decreased pulmonary compliance, or peak insufflation
l/min
l/min
pressure anticipated to exceed 20 cm H
pressure seal (approximately 20 cm H
34
38
4. Adult patients who are unable to understand instructions or cannot adequately
answer questions regarding their medical history, since such patients may be
contraindicated for the device.
5. The device should not be used in the resuscitation or emergency situation in
patients who are not profoundly unconscious and who may resist device insertion.
21.3
21.8
ADVERSE EFFECTS:
There are reported adverse reactions associated with the use of laryngeal mask
airways. Standard textbooks and published literature should be consulted for
specific information.
WARNINGS:
1. To avoid trauma, excessive force must be avoided at all times.
2. Do not use if the device is damaged or its unit packaging is damaged or opened.
3. When using the device in special environmental conditions, such as enriched
oxygen, ensure that all necessary preparation and precautions have been taken,
especially with regard to fire hazards and prevention. The device may be
flammable in the presence of lasers and electrocautery equipment.
4. 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. Failure of any one test
indicates the device should not be used.
5. Do not immerse or soak the device in liquid prior to use.
6. When applying lubricant avoid blockage of the airway aperture with the
lubricant.
7. After the pre-use checks are complete never overinflate the cuff over 60cm H
Excessive intra-cuff pressure can result in malposition and pharyngo-laryngeal
morbidity, including sore throat, dysphagia and nerve injury.
8. 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
the device, may possibly provoke an allergic reaction, or may affect the
surrounding structures, including the vocal cords.
9. The device does not prevent regurgitation or aspiration. Its use in anaesthetised
patients should be restricted to fasting patients. A number of conditions
predispose to regurgitation under anaesthesia. Do not use the devices without
taking appropriate precautions to ensure the stomach is empty.
10. Diffusion of nitrous oxide, oxygen, or air may increase or decrease cuff volume
and pressure. In order to ensure that cuff pressures do not become excessive, cuff
pressure should be measured regularly during a case with a cuff pressure monitor.
11. Refer to MRI information section prior to using the devices in MRI
environment.
CAUTIONS:
1. Laryngeal spasm may occur if the patient becomes too lightly anaesthetized
during surgical stimulation or if bronchial secretions irritate the vocal cords during
emergence from anaesthesia. If laryngeal spasm occurs, treat the cause. Only
remove the device when airway protective reflexes are fully competent.
2. Do not pull or use undue force when handling the inflation line or try to remove
the device from patient by the inflation line as it may detach from the cuff spigot.
3. Only use a syringe with standard luer taper tip for inflation or deflation.
4. Only use with the recommended manoeuvres described in the instructions for
use.
5. If airway problems persist or ventilation is inadequate, the device should be
removed and an airway established by some other means.
Page 2 of 5
O, because the device forms a low-
2
O) around the larynx.
2
O.
2
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