Applied Medical Technology CINCH 930L Instrucciones Para Su Utilización página 2

ENGLISH
Intended Use
The tube securement device is intended to provide external securement of
medical tubes and lines.
Indications for Use
The tube securement device is indicated for use in patients of all ages who
require external securement and strain relief of medical tubing.
Contraindications
Contraindications for the tube securement device include but are not limited to:
• Known allergies to silicone or silicone based adhesive • Compromised skin conditions such as open wounds /
sores, rash, infection, or burns • Placement closer than 5 cm to any tubing insertion site
Clinical Benefits
Clinical benefits to be expected when using the tube securement device include but are not limited to:
• Prevents lines from becoming tangled or snagged • Provides motion control where the lines enter the body •
Provides external strain relief of medical tubing • Initial defense for inadvertent pulls that could otherwise displace
the line
Performance Characteristics
Performance characteristics of the tube securement device include but are not limited to:
• Accommodate pertinent tubing size • Comfortable when not in use • Permit multiple external securement cycles •
Non-irritating to skin for majority of patient population
Placing the tube securement device
Note: This device is intended to be used by qualified professionals and lay users.
Note: Remove tube securement device from backing. Tube securement device should be placed on clean,
healthy, intact skin at a minimum of 5 cm from any tube insertion points.
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Caution: If redness or irritation occurs, stop use and consult a healthcare professional.
Device Longevity
The tube securement device is meant to be periodically replaced for optimal performance, functionality, and clean-
liness. Typical device longevity ranges from 3-5 days. The tube securement device should be replaced if tears,
adhesive is separating from the skin, or other signs of failure are noted. To replace the device, first remove the
device by releasing the clasping mechanism and gently removing the device from the skin. The device can be
placed in conventional waste for disposal. The skin should be cleaned and a new device applied if needed.
WARNING: This device is intended for single use. Do not reuse, reprocess or re-sterilize 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.
®
CINCH 930L
Tube Securement Device
Instructions for Use
Clean Surface
Place tube on device
(perpendicular to the
strap)
CINCH
CINCH
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4
®
417M
Tubing size
range
®
CINCH 930L 9F - 30F
®
417M 4F - 17F
Apply device to surface
Pull the tip of the strap
through the slit in the device
Caution: Do not overtighten
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