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EN ‐ English
INSTRUCTIONS FOR USE –
LMA Unique PreCurved™ & LMA Unique
PreCurved™ Cuff Pilot™
CAUTION: Federal (USA) law restricts this device to sale by or on the
order of a physician.
WARNING: LMA Unique PreCurved™ and LMA Unique PreCurved™ Cuff Pilot™
are supplied sterile for single use only, should be used straight from the pack
and should be discarded after use. They must not be re‐used. Reuse may cause
cross infection and reduce product reliability and functionality.
WARNING: Re‐processing of LMA Unique PreCurved™ and LMA Unique
PreCurved™ Cuff Pilot™ intended for single use only may result in degraded
performance or loss of functionality. Re‐use of single use only products may
result in exposure to viral, bacterial, fungal, or prionic pathogens. Validated
cleaning and sterilisation methods and instructions for reprocessing to original
specifications are not available for these products. LMA Unique PreCurved™ and
LMA Unique PreCurved™ Cuff Pilot™ are not designed to be cleaned, disinfected,
or re‐sterilised.
GENERAL INFORMATION:
Unless otherwise stated, the reference to "device" stated on this IFU applies to
both versions of LMA Unique PreCurved™ and LMA Unique PreCurved™ Cuff
Pilot™.
The devices are only for use by medical professionals trained in airway
management.
DEVICE DESCRIPTION:
Both the LMA Unique PreCurved™ and LMA Unique PreCurved™ Cuff Pilot™ are
not made with natural rubber latex and phthalates. They are supplied sterile
(sterilised by Ethylene Oxide) for single use only.
LMA Unique PreCurved™ and LMA Unique PreCurved™ Cuff Pilot™ provide easy
insertion without the need for digital or introducer tool guidance.
LMA Unique PreCurved™ and LMA Unique PreCurved™ Cuff Pilot™ have three
main components: airway tube, cuff and inflation system.
The inflation system of LMA Unique PreCurved™ consists of an Inflation Line with
Pilot Balloon and Check Valve for cuff inflation and deflation. The Pilot Balloon
provides a rough indication of the pressure within the cuff and the Check Valve
prevents leakage of air and maintains the pressure in cuff.
The inflation system of LMA Unique PreCurved™ Cuff Pilot™ consists of an
Inflation Line with a Cuff Pilot™. The Cuff Pilot™ enables constant visualisation of
pressure inside the mask cuff. It replaces the standard pilot balloon and is to be
used in the same way for cuff inflation and deflation.
LMA Unique PreCurved™ is MR conditional. Refer to MRI information section prior
to using the device in MRI environment.
LMA Unique PreCurved™ Cuff Pilot™ is MR Safe. The term 'MR Safe' means that it
poses no known hazards in all MR environments.
Figure 1: The LMA Unique PreCurved™ components
LMA Unique PreCurved™ components (Figure 1):
a)
Connector
b)
Airway Tube
c)
Backplate
d)
Cuff
e)
Inflation Line
f)
Pilot Balloon
g)
Check Valve
Figure 2: LMA Unique PreCurved™ Cuff Pilot™ components
LMA Unique PreCurved™ Cuff Pilot™ components (Figure 2):
a)
Connector
b)
Airway Tube
c)
Backplate
d)
Cuff
e)
Inflation Line
f)
Cuff Pilot™
Page 1 of 5
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Related Manuals for Teleflex LMA Unique PreCurved
Summary of Contents for Teleflex LMA Unique PreCurved
- Page 1 EN ‐ English Figure 1: The LMA Unique PreCurved™ components INSTRUCTIONS FOR USE – LMA Unique PreCurved™ & LMA Unique PreCurved™ Cuff Pilot™ CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. WARNING: LMA Unique PreCurved™ and LMA Unique PreCurved™ Cuff Pilot™ are ...
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Page 2: Indication For Use
Table 1: Specification for the device RISK‐BENEFIT INFORMATION: Device Size When used in the profoundly unresponsive patient in need of resuscitation or in a 1 1.5 2 2.5 3 4 difficult airway patient on an emergency pathway (i.e., “cannot intubate, cannot Patient ventilate”), the risk of regurgitation and aspiration must be weighed against the Up to 5‐10 10‐20 20‐30 30‐50 50‐70 70‐100 potential benefit of establishing an airway. Weight (kg) 5 Airway 15 mm male (ISO 5356‐1) CONTRAINDICATIONS: Connector Due to the potential risk of regurgitation and aspiration, do not use the device as a Inflation Luer cone (ISO 594‐1) substitute for an endotracheal tube in the following elective or difficult airway Valve ... -
Page 3: Preparation For Use
6. Careful handling is essential. Avoid contact with sharp or pointed objects at all Warning: A water‐soluble lubricant, such as K‐Y Jelly®, should be used. Do not use times to prevent tearing or perforation of the device. Do not insert the device silicone‐based lubricants as they degrade the device components. Lubricants unless the cuffs are fully deflated as described in the instructions for insertion. containing Lidocaine are not recommended for use with the device. Lidocaine can 7. Gloves should be worn during preparation and insertion to minimize delay the return of the patient’s protective reflexes expected prior to removal of contamination of the airway. ... - Page 4 MAINTAINING THE AIRWAY: 1. Obstruction can occur if the device becomes dislodged or is incorrectly inserted. The epiglottis may be pushed down with poor insertion technique. Check by auscultation of the neck and correct by re‐insertion or elevation of the epiglottis using a laryngoscope. 2. Malposition of mask tip into the glottis may mimic laryngospasm and/or bronchospasm. Figure 7: Swing the device Figure 8: Advance the 3. Avoid moving the device about in the pharynx when the patient is at a light inward with circular ...
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Page 5: Symbol Definition
Manufacturer publisher. LMA, LMA Better by Design, LMA Unique PreCurved, Cuff Pilot and Teleflex are Consult IFU on this website: www.LMACO.com trademarks or registered trademarks of Teleflex Incorporated or its affiliates. The information given in this document is correct at the time of going to press. ...
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