AMT Clamp Instrucciones Para Su Utilización página 2

ENGLISH
INDICATIONS, CONTRAINDICATIONS, DEVICE LONGEVITY
Intended Use
The AMT Clamp™ is intended to maintain the connection between feeding set insertion points.
Indications for Use
The AMT Clamp™ is indicated for use in patients of all ages with a history of their feeding set becoming disconnected from
their feeding device.
Contraindications for Use
The AMT Clamp™ is contraindicated for use in patients with a history of their feeding tubes being pulled out.
Device Longevity
The AMT Clamp™ is meant to be periodically replaced for optimal performance, functionality, and cleanliness. AMT recom-
mends that the clamp be changed at least every 4 weeks or as often as indicated by your healthcare professional. Device
performance and functionality can degrade over time depending on usage and environmental conditions. Some factors that
can lead to reduced longevity include: frequency of use, trauma to the device, and overall care of the AMT Clamp™.
The AMT Clamp™ should be replaced if tears or other signs of failure are noted. The device can be placed in conventional
waste for disposal.
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.
CLINICAL BENEFITS, PERFORMANCE CHARACTERISTICS
Clinical Benefits
Clinical benefits to be expected when using the AMT Clamp™ include but are not limited to:
 Prevents feeding set from becoming disconnected from feeding device
 Ensures the patient receives the essential nutrients while avoiding the mess of lost formula.
Performance Characteristics
Performance characteristics of the AMT Clamp™ include but are not limited to:
 Soft, comfortable, no slip material
 Allows multiple removal and placement cycles
 Compatible with various manufacturers' enteral feeding tubes, christmas tree adapters, y-ports and g-tubes.
Note: This device is intended to be used by qualified professionals and lay users.
1. Make sure the christmas tree adapter (A) and the feeding set/G-tube (B) are connected securely per original manufactur-
er's directions.
2. Place the small bottom ring of the AMT Clamp™ (C) around the base of the feeding set/G-tube (B) just below the side port.
3. Secure the wrap-strap (D) around the bottom ring of the AMT Clamp™ by tucking the strap into the slot and placing the tab
into pocket (E).
4. Stretch the main straps so the large top ring (F) is above the christmas tree adapter (A) and snap the top ring around the
tubing.
5. Secure the wrap-strap (G) around the top ring of the AMT Clamp™ by tucking the strap into the slot and placing the tab into
pocket (H).
6. Ensure your feed set connection and AMT Clamp™ is not bent and all parts appear to be in their proper places before you
begin enteral feeding.
WARNING: Excessive tension may inadvertently remove the feeding device from the patient thereby disrupting the
gastrostomy site, which could result in tissue necrosis, infection, peritonitis, sepsis, and associated sequelae.
WARNING: Improper placement of the AMT Clamp™ may result in occlusion of the feeding device.
WARNING: If unable to replace feeding device easily, contact your physician immediately.
Note: Feeding system should be checked every two hours (or as needed) to ensure safe delivery of nutritional formula.
Medical Device
Non-Sterile
AMT Clamp™ Feeding Tube Connector
INSTRUCTIONS FOR USE
PLACING THE AMT CLAMP™
Not made with DEHP (Di
(2-ethylhexyl)Phthalate)
Not made with natural
rubber latex
Prescription
Only
MR Safe
Single
Patient
Use Only
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