EyeGiene Insta-Warmth Starter System (1 Mask and 10 Pairs of Warming Wafers)

About the Product

A reusable eye mask with an adjustable strap, used with single use disposable warming wafers that are inserted into a pouch on each side of the mask. No microwave, hot water or stove is required.

People shop this as a warm compress system for use away from a microwave, hot water or a stove. A pair of wafers is dropped into the pouches, warms on contact with the air, and the mask is worn over closed eyelids for at least 10 minutes. The starter system pairs the reusable mask with 10 pairs of wafers, enough for 10 uses.

Materials

• Reusable eye mask A hand washable mask with an adjustable strap and a pouch on each side that each hold one warming wafer.
• Air activated warming wafers Single use wafers that warm on contact with the air and activate automatically once they are taken out of their sealed package and placed into the mask.
• Sealed foil pouch Each pair of wafers is sealed in a foil pouch, and the wafers stay inert until the pouch is opened and they meet the air.

What Is Included

• One (1) EyeGiene Eye Mask
• 10 pairs (20) of Warming Wafers

Specifications

• Warming wafers: single use, disposable, supplied two per foil pouch.
• Heat duration: 10 to 15 minutes, with the warmth continuing for over 10 minutes.
• Suggested wear time: at least 10 minutes.
• Mask: reusable, hand washable, adjustable strap.
• No microwave, hot water or stove required.

How to Use

1. Prior to opening the warming wafers foil pouch, adjust the strap so eye mask fits snugly and comfortably against your eyelids.
2. Open the foil pouch, remove the two warming wafers, and insert one into the right side of the eye mask, and the other one into the left side of the eye mask.
3. Find a comfortable position and relax. Place the eye mask over both eyes with eyelids gently closed. For maximum effectiveness, we suggest that you wear the eye mask for at least 10 minutes.
4. When finished, discard the warming wafers. The eye mask can be used multiple times, and is washable by hand.

Care and Cleaning

• The EyeGiene Eye Mask can be hand washed in cold water with dishwashing or delicate laundry detergent, and air dried.
• The mask may last 3 to 6 months or longer depending on the frequency of washings.
• The warming wafers are for one time use only and are discarded after each use.

Warnings

• Remove contact lenses or other devices prior to use. If you had recent cataract or other eye surgery, ask your eyecare specialist before use.
• Avoid additional pressure on the eye mask once it is in use. System is to be used with eyelids closed. Use only one (1) warming wafer at a time in each pouch of the eye mask.
• Do not use on unhealthy, numb, damaged, or broken skin. Do not use after eyelid surgery or eye surgery without approval by your eye surgeon.
• Do not microwave or attempt to reheat. Warming units are for one-time use only. Discard appropriately after use.
• Do not use if eyelids do not close normally. Do not share the eye mask.

Regulatory

• FDA establishment registration number 3011298700, Shanghai Warmyou Industry Co., Ltd., listing the proprietary name EyeGiene.
• Product code IMD, device name "Pack, Hot Or Cold, Disposable".
• Device class: Class I.
• Classification regulation: 21 CFR 890.5710.
• Under 21 CFR 890.5710(b) this device type is exempt from the premarket notification procedures of 21 CFR part 807 subpart E, except when intended for use on infants. No 510(k) number applies.