Product Information
About the Product
The TearRestore Thermal Mask is a reusable open eye warm compress frame made from a flexible and resilient polymer, in a single size shaped to anatomical standards. This listing is the mask with its reusable heat pack. It holds a TearRestore heat pack, which is what supplies the warmth and is sold separately, as is the reactivation kettle.
The distinguishing feature is the open eye design. The mask has eye openings, so the wearer keeps both eyes open and can read, work or watch television for the whole session instead of lying down with the eyes covered. A warmed heat pack clips into the mask and rests against the eyelids for a session of 10 to 15 minutes, once daily, or twice daily as needed. Flexing the metal disc inside a pack starts the sodium acetate crystallising, and the pack heats without a microwave. Between sessions the pack is returned to liquid in boiling water and used again, so the system runs without a microwave.
Materials
- Flexible and resilient polymer The material of the reusable mask frame.
Specifications
| Type | Reusable open eye warm compress frame |
| Sizing | One size, shaped to anatomical standards |
| Mask material | Flexible and resilient polymer |
| Session length | 10 to 15 minutes |
| Frequency | Once daily, or twice daily as needed |
| Heat source | TearRestore heat pack, sold separately |
| Heating method | Metal disc flexed by hand, no microwave |
| Reactivation | Boiling water, 5 to 10 minutes, or the TearRestore reactivation kettle |
How to Use
- Flex the metal disc back and forth until crystals start to form. The pack will begin to heat.
- Massage the pack until it is heated evenly.
- Test the temperature of the heat pack with the back of your hand. If too warm, wait 1 minute before placing.
- Place the heat pack into the mask and position the mask over the eyelids, with the eyes open.
- Wear for 10 to 15 minutes, once daily, or twice daily as needed.
Care and Cleaning
Reset each heat pack in boiling water for 5 to 10 minutes, or in the TearRestore reactivation kettle. Do not microwave.
If the contents have not fully liquefied, boil for a few extra minutes, 15 minutes maximum. All contents of the heat pack should be completely liquid before removing from the boiling water.
Let the heat packs cool to room temperature after boiling before using them again. Each pack can be reactivated up to 90 times.
Warnings
- Do not microwave the heat packs.
- Test the temperature of the heat pack with the back of your hand. If too warm, wait 1 minute before placing.
- All contents of the heat pack should be completely liquid before removing from the boiling water.
- Let the heat packs cool to room temperature after boiling before using them again.
Storage
Store the heat packs as a liquid, fully reset and cooled, if you are not using them every day.
Regulatory
TearRestore Inc is a registered device establishment, registration number 3017978518, Arden Hills, Minnesota. The TearRestore Thermal Mask is listed under product code IME, pack, hot or cold, reusable, 21 CFR 890.5700, device class 1.
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NDC 24208-730-06
NDC 24208-585-64
NDC 24208-295-25
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