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EN – English
INSTRUCTIONS FOR USE –
LMA
Unique™ (S) & LMA
Cuff Pilot™
CAUTION: Federal (USA) law restricts this device to sale by or on the
order of a physician.
WARNING: LMA
Unique™ (S) and LMA
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
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
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™ (S) & LMA
The devices are only for use by medical professionals trained in airway
management.
DEVICE DESCRIPTION:
Both LMA
Unique™ (S) and LMA
silicone and are supplied sterile (sterilised by Ethylene Oxide) for single use only.
The devices are not made with natural rubber latex and phthalates.
LMA
Unique™ (S) and LMA
components: airway tube, cuff and inflation system.
The inflation system of LMA
Unique™ (S) consists of an Inflation Line with Pilot
Balloon and Check Valve for cuff inflation and deflation. The Pilot Balloon provides
an indication of the pressure within the cuff and the Check Valve prevents leakage
of air and maintains the pressure in cuff.
Unique™ (S) Cuff Pilot™ consists of an Inflation Line
The inflation system of LMA
with Cuff Pilot™ technology. Cuff Pilot™ technology enables constant visualisation
of inside mask cuff pressure. It replaces the standard pilot balloon and to be used
in the same way for cuff inflation and deflation.
LMA
Unique™ (S) is MR conditional. Refer to MRI information section prior using
the device in MRI environment.
Unique™ (S) Cuff Pilot™ is MR Safe. The term 'MR Safe' means that it poses
LMA
no known hazards in all MR environments.
Unique™ (S)
Unique™ (S) Cuff Pilot™ are supplied
Unique™ (S) and LMA
Unique™ (S) Cuff
Unique™ (S) and LMA
Unique™ (S) Cuff
Unique™ (S) Cuff Pilot™.
Unique™ (S) Cuff Pilot™ are made primarily of
Unique™ (S) Cuff Pilot™ have three main
Figure 1: LMA
Unique™ (S) components
LMA
Unique™ (S) components (Figure 1):
a)
Connector
b)
Airway Tube
c)
Backplate
d)
Cuff
e)
Inflation Line
f)
Pilot Balloon
g)
Check Valve
Unique™ (S) Cuff Pilot™ components
Figure 2: LMA
Unique™ (S) Cuff Pilot™ components (Figure 2):
LMA
a)
Connector
b)
Airway Tube
c)
Backplate
d)
Cuff
e)
Inflation Line
f)
Cuff Pilot™
Page 1 of 5
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Summary of Contents for Teleflex LMA Unique Cuff Pilot
- Page 1 Figure 1: LMA Unique™ (S) components EN – English INSTRUCTIONS FOR USE – Unique™ (S) & LMA Unique™ (S) Cuff Pilot™ CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. ...
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Page 2: Adverse Effects
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 Patient difficult airway patient on an emergency pathway (i.e., “cannot intubate, cannot Weight 5-10 >100 ventilate”), the risk of regurgitation and aspiration must be weighed against the to 5 potential benefit of establishing an airway. -
Page 3: Preparation For Use
6. Careful handling is essential. Avoid contact with sharp or pointed objects at all the device, may possibly provoke an allergic reaction, or may affect the times to prevent tearing or perforation of the device. Do not insert the device surrounding structures, including the vocal cords. - Page 4 Thumb Insertion Method: Warning NEVER OVERINFLATE THE CUFF. This technique is suitable for patients in whom access to the head from behind is difficult or impossible and during cardiopulmonary resuscitation. The device is held with the thumb in the position occupied by the index finger in the standard MAINTAINING THE AIRWAY: technique (Fig.8).
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Page 5: Symbol Definition
Manufacturer publisher. Consult IFU on this website: www.LMACO.com Teleflex, the Teleflex logo, LMA, LMA Unique and Cuff Pilot are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the US and/or other countries. Air inflation volume/Intra-cuff pressure ...