instructions for use - warmilu.com · at warmilu, our goal is to provide non-electric, safe and...
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InstaWarmer PackInstructions for Use
Warmth when you need it.
Our Mission
Contact Us
At Warmilu, our goal is to provide non-electric, safe and instant warmth to patients around the world.
AddressWarmilu8186 Jackson Rd. Suite C Ann Arbor, MI 48103 USA
Websitewww.warmilu.com Phone+1-855-927-6458
Email [email protected]
Manufacturer Representative Grace HsiaCEO/Co-Founder+1-855-927-6458 ex. [email protected] Version 1.0 Date Drafted: 12/4/2017
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Table of Contents
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6
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Product Description
Activating the InstaWarmer
Disposal
Contact Information
Product Specification
Using the InstaWarmer
Safety
Warnings
Autoclaving the InstaWarmer
Disclaimer
Product Contents4
Storage
Intended Use4
6677
4 FDA Cleared
The InstaWarmer is a semi-transparent film warming pack containing the proprietary Warmilu non-toxic heat solu-tion (US utility patented US 9,605,874), and a metal disk activator contained in one corner of the pack. The pack can be observed in two states: pre-activation (liquid state) and post-activation (solid state). While in a liquid state, the pack will appear clear with an opaque white gel distributed throughout. While in a solid state, the heat solution will be hard and white in color, with a crystalline texture. The In-staWarmer generates warmth instantly at the press of the disk. The heat pack can be reset and sterilized up to 100 times through autoclave, and is designed to not exceed a temperature of 109.4ºF (43ºC) +/- 1º and remain warm for 2-4 hours.
Product Description
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Activator Disk
Serial #
Use Tracking
InstaWarmer Pack
InstaWarmer Pack Weight: 3.9 lbs (1.8 kg)InstaWarmer Pack Dimensions: 16 in x 9 in x 1 in(40.6 cm x 22.8 cm x 2.5 cm)Peak Temp: 109.4°F (43°C) +/- 1º (From a start temp of 64-68-75ºF (20-24ºC))Duration: 2-4 Hours
Warnings
DO NOT use the InstaWarmer pack directly on a patient’s skin or on broken skin. Monitor patients for signs of redness and swelling. Remove InstaWarmer pack if patient expresses discomfort or irritation. Use under the supervision of medical personnel.
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Sodium acetate (food grade), water and thermal buffer.Do not swallow. All contents are non-toxic. However, if contents come in contact with skin or eyes, flush with water.
Product Specifications
Product Contents
The InstaWarmer provides non-electric warmth to patients to aid in reducing pain and discomfort from arthritis, surgical operation, delivery and labor, and other applica-tions as determined by a physician. To avoid possible injury, follow all directions carefully. Retain this insert for future reference.
Intended Use
Warmilu is a FDA registered and listed manufacturer. The InstaWarmer is a FDA Class 1 registered hot reusuable pack.
FDA Cleared
The InstaWarmer pack is ready to be activated when it is in a liquid state and at room temperature. DO NOT activate an InstaWarmer pack that is hot to the touch. Step 1(option A): Lay the InstaWarmer pack on a flat surface and grasp the metal activator disk (located in one corner of the pack) be-tween the thumb and forefinger of both hands. Step 2: Click it a few times to activate the phase-change and generate warmth. You will hear a clicking sound. Step 3: The liquid in the pack will begin turning into a solid. You will feel warmth in seconds. Step 4: Knead the InstaWarmer for 30 seconds to evenly distribute the thermal buffer before use. Step 5: Mark off corresponding use on label with permanent marker, and wrap InstaWarmer pack in clean hospital linens.
Step 1 (option B): If you experience difficulty in activating the InstaWarmer pack, roll the pack starting from the end opposite the activator, to force the phase-change liquid into the space around the activator disk. Then click the disk again.
Activating the InstaWarmer Pack
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1A 2 3
4 5 1B
Autoclaving the InstaWarmerThe InstaWarmer pack can be reset and sterilized in a stan-dard hospital autoclave cycle. Step 1: Wipe InstaWarmer clean with alcohol wipes, or other sanitizing solution. Step 2: Wrap InstaWarmer in a standard sterilization pouch or autoclave wrap. Autoclave Settings: Use gravity cycle at 121ºC for 15 minutes, with a 15 minute dry time. Step 3: Let cool to room temperature.
Check the InstaWarmer for any signs of stress or damage before using on patient. Dispose of pack if any is observed.
Autoclave sterilization and reset validated by Pacific Bio-
Once the InstaWarmer pack is activated, it is now ready for use. Wrap the InstaWarmer pack in a blanket, towel, pillow case, or other clean hospital linen. Apply the InstaWarmer to the location requiring warmth. Check the patient periodically for signs of irritation.
Once the InstaWarmer pack has cooled, remove and reset it for the next use. If patient still requires warmth, activate a second InstaWarmer pack while the first is being reset.
Using the InstaWarmer
StorageStore the InstaWarmer in the liquid (unactivated) state at room temperature for up to two years.
DisposalPlease dispose of pack in general hospital waste when the InstaWarmer pack has been used 100 times or has become damaged, unusually soiled, or expires.
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All intellectual property belongs to Warmilu. Warmilu reserves the right to make changes to the specifications shown herein. Please contact Warmilu to receive updates and learn about changes to our products and procedures. A medical professional must always rely on his or her own professional clinical judgment when deciding whether to use the InstaWarmer pack when treating a particular patient. Warmilu does not dispense medical advice and recommends that medical professionals be trained in the use of the InstaWarmer before using it with a patient. Do not use the InstaWarmer on patients without first seeking advice from a medical professional.
a. When resetting your InstaWarmer, follow proper autoclave safety procedures. Do not grab a hot pack directly. Use appropriate safety gear, such as hot pads or non-metallic utensils, to protect hands and body from making contact with heated surfaces.
b. Do not stab, cut, or perforate the external material of your InstaWarmer pack. If pack contents come in contact with skin or eyes, rinse under cool water. If pack is damaged or leaking, discontinue use immediately and allow pack contents to return to room temperature before disposing of pack with general waste. Do not place pack contents into sink.
d. Follow proper cleaning and sanitizing instructions for your InstaWarmer to prevent cross infection or damage to the product.
f. Only activate the InstaWarmer pack once it has completely cooled to room temperature to prevent over heating.
Safety
Disclaimer
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www.warmilu.com [email protected] +1-855-927-64588186 Jackson Rd., Suite C Ann Arbor, MI 48103 USA