Bruder Cold Therapy Eye Compress

About the Product

A reusable cold compress for the eye area, chilled in a freezer and applied over the eyes. It uses a proprietary non-gel pad that stays soft and flexible when frozen and can be applied directly to the skin without a cover. It is condensation free, double sealed and latex free, and it is washable and reusable.

This is the cold version rather than a warm compress, kept in the freezer and applied over the eye area for 15 to 20 minutes, and not more than 20 minutes in any 2 hour period. Because the pad stays soft and dry straight from the freezer, it is applied directly to the skin without a cover or a wrapped towel.

Materials

• Non-gel cold pad The Protocold pad, which stays soft and flexible at freezer temperature and gives up its cold on a timed release rather than all at once.
• Double sealed outer construction The condensation free sealed shell, which keeps the outside dry so the compress can sit against the skin without a cover.
• Securing straps The straps that hold the compress in position over the eye area during use.

What Is Included

• One Bruder Cold Therapy Eye Compress with securing straps

Specifications

How to Use

1. Place in the freezer for 2 hours, or store in the freezer between uses.
2. Apply over your eyes for 15 to 20 minutes.
3. Do not use for more than 20 minutes in a 2 hour period.

Care and Cleaning

• Wipe clean with an antiseptic, or surface wash with cold water as needed.
• Do not machine wash.
• Allow the surface to dry completely before returning the compress to the freezer.
• Wash if the compress becomes soiled rather than after every use.

Warnings

• Do not use for more than 20 minutes in a 2 hour period.
• After surgery, every case is different, so consult your surgeon or support staff for instruction.

Regulatory

This product is listed with the FDA by The Hilsinger Company Parent, LLC, 575 West Street, Suite 120, Mansfield, MA 02048, under FDA establishment registration number 1039131. That registration lists the proprietary names Bruder, Protocold, Thermalon and MediBeads under product code IME, device name "Pack, Hot Or Cold, Reusable", regulation number 21 CFR 890.5700, device class 1.

21 CFR 890.5700 classifies the device as Class I (general controls) and states that the device is exempt from the premarket notification procedures in subpart E of part 807. There is therefore no 510(k) number for this product, and none is required. Nothing here should be read as a statement of FDA approval or clearance.