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ADDENDUM FOUR P/N CLA318 Rev.001
Portex
®
Point-Lok
®
- SHARPS SAFETY DEVICE (STERILE)
Read Completely Before Use
Description
The Portex
®
Point-Lok
®
needle protection device is designed to provide needle stick
protection utilizing a simple one-handed technique. The design will accommodate most
style needles in the size range of 16 to 30 gauge.
The Point-Lok
®
device will help users to comply with the following OSHA rules and
r
egulations:
(OSHA Rules and Regulations on Bloodborne Pathogens)*
Needle Sticks:
“(A) Contaminated needles ... shall not be bent, recapped or removed unless the employer
can demonstrate that no alternative is feasible or that such action is required by a specific
medical or dental procedure.”
“(B) Such bending, recapping or needle removal must be accomplished through the use
of a mechanical device or a one-handed technique.”
Exposure to contaminated blood:
“(XI) All procedures involving blood or other potentially infectious materials shall be
performed in such a manner as to minimize splash, spray, splattering, and generation of
droplets of these substances.”
*U.S. Labor Occupational Safety and Health Administration, OSHA Rules and Regulations
Of Bloodborne Pathogens 29CFR1910.1030
Indications For Use
This device is intended as a single use needle protection device, which covers the end of
the needle after use to help prevent needle sticks. This device is designed for use with 16
gauge through 30 gauge needles.
Contraindications
None known.
Warnings
A needle stick with a contaminated needle may cause infectious diseases.
Intentional misuse of the Point-Lok
®
needle protection device may result in a needle stick
with a contaminated needle.
Bent or damaged needles cannot be properly secured in this device. If the needle is bent,
do not try to straighten the needle or attempt to engage the needle into this protective
device. The Point-Lok
®
device may not properly contain a bent and / or damaged needle.
If a bent or damaged needle was forced in to this device, it could cause a needle to
protrude through the device, which could result in a contaminated needle stick.
Do not ever attempt to place needle into Point-Lok
®
device while holding the device. This
may result in an accidental needle stick injury.
Use this device only on a flat, secure, sturdy surface when attempting to engage needle in
the Point-Lok
®
device. Attempting to do so otherwise could possibly lead to a
contaminated needle stick.
Do not forcibly insert needles into Point-Lok
®
device as this may lead to accidental
penetration of base unit and could result in an accidental needle
stick injury.
Proofed by: Date:
Dimensions checked: Copy checked:
RC041264
McGaw Park, IL
Richard Cisneroz
04-05-12
361-26801
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