AMT Bridle Standard Directions, Indications, & Contraindications For Use Download Page 6

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Family of Nasal Tube Retaining Systems

AMT

Bridle

™

Vomer

Bone

Attached Clip

Probe

Stylet

Flexible

Bridle

Catheter

Magnetic

Connection

Made in America

Cleveland, Ohio

Caution: Federal (USA) law restricts this device to sale, distribution, and use by or on the order of a physician.

A thorough nasal exam is recommended before AMT Bridle

™

or AMT Bridle Pro

placement in patients to ensure that adequate bone remains in the posterior septum to support

the AMT Bridle System. A nasal exam should also be conducted after AMT Bridle

™

or AMT Bridle Pro

placement to ensure that the umbilical tape or bridle tubing loop has

passed behind the nasal septum rather than through a septal perforation.

NOTE: System is supplied non-sterile, for single use only. Please inspect all contents of the kit for damage. If damaged, do not use product.
INTENDED USE - The Bridle Family is intended to be used by pediatric and adult patients to secure nasal feeding tubes in place in order to optimize nutrient delivery

and reduce feeding tube pull out.

WARNING: Excessive traction on the AMT Bridle

™

or AMT Bridle Pro

may cause tube displacement or nasal injury; an alternative means of securing the nasal

tube should be explored.

WARNING: This device is intended for single use. Do not reuse or reprocess this medical device. Doing so may compromise biocompatibility characteristics,

device performance and/or material integrity; any of which may result in potential patient injury, illness and/or death.
NOTE: Please contact AMT, our Authorized Representative (EC Rep), and/or the competent authority of the member state in which you are established if a serious

incident has occurred in relation to the device.

NOTE: These devices are intended to be placed only by qualified professionals.

NOTE: No patient sedation is required for placement of the AMT Bridle

™

or AMT Bridle Pro

. However, sedation may be used at the healthcare provider’s

discretion if appropriate.

WARNING: Placement of the bridle may be very difficult or impossible for pediatric patients who are nasally intubated.

It is recommended that the bridle is placed prior to any nasal tubes for pediatric patients.

INDICATIONS FOR USE - The AMT Bridle™ or AMT Bridle Pro

- Nasal Tube Retention System is indicated to prevent inadvertent displacement or removal of

Nasogastric/Nasointestinal (NG/NI) tubes.
CONTRAINDICATIONS FOR USE - This device is contraindicated for patients with nasal airway obstructions or abnormalities, and facial and/or cranial fractures.

Do not use on patients with thrombocytopenia (<100 k/ul) or immediately post septoplasty. Do not use on patients with a graft vomer bone. Extreme caution

should be used with premature infants and neonatal patients. Do not use on patients that may pull on the AMT Bridle™ or AMT Bridle Pro

to such a degree

as to cause serious injury.
CLINICAL BENEFITS

Clinical benefits to be expected when using the AMT Bridle

™

or AMT Bridle

Pro

include but are not limited to:

• Dramatically reduces nasal tube pullout
• Minimizes interruption of tube feedings
• No tape or sutures necessary for securement
• Optimal nutrition leads to optimal recovery
• Savings on tubes, x-rays, and nursing time

PERFORMANCE CHARACTERISTICS

Performance characteristics of the AMT Bridle

™

or AMT Bridle Pro

include

but are not limited to:

• MR safe after proper placement
• No patient sedation required
• May be placed in less than a minute
• Unique design with firm grip to secure nasal tubes from sizes 5F to 18F
• Secured without messy adhesive tape or sutures
• Designed for use with ANY brand of nasal tube

WARNING: It is critical that the device is properly secured around the vomer bone and that a nasal exam is performed after placement to ensure placement is correct.

If the device is not properly secured around the vomer bone, such as through a septal deviation, excessive tension applied to the device may cause extreme damage

to or removal of the septum.

The Bridle clip, tape, and catheter tubing are MR safe
The Bridle probe, catheter, and stylet are MR unsafe
Not made with DEHP

Not made with natural rubber latex

Medical Device
Single Use Only