VIA Technologies Warmilu IncuBlanket User manual
Spread the warmth. Save lives.
IncuBlanket Kit User Manual
IncuBlanket Kit User Manual
Our Mission
Contact Us
At Warmilu LLC, our goal is to provide non-electric, safe and instant
warmth to infants around the world.
Address
Warmilu LLC
8186 Jackson Rd. Suite C
Ann Arbor, MI 48103 USA
Website
www.warmilu.com
Phone
+1-855-927-6458
Email
Manufacturer Representative
Grace Hsia
CEO/Co-Founder
+1-855-927-6458 ex. 700
Version 4.0 Kenyan
Date Drafted: 3/9/2017
Date Revised: 10/1/2017
Page 1
Table of Contents
IncuBlanket Kit Introduction
Using Your IncuBlanket and InstaWarmer
IncuBlanket and InstaWarmer Information
Company Overview
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8
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11
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Product Description
Boiling the InstaWarmer Pack
IncuBlanket Materials
Caring for Your IncuBlanket and InstaWarmer
Contact Information
Intended Use
Activating the InstaWarmer Pack
Safety
Washing Your IncuBlanket
Denition of Hypothermia
Prepping and Using the IncuBlanket
Disclaimer
Caring for Your InstaWarmer
IncuBlanket Kit User Manual Page 2
Use Instructions (Visual Guide)
4
Positioning the Infant10
Clinical Trials6
8 Autoclaving the InstaWarmer Pack
IncuBlanket Kit User Manual Page 3
The Warmilu IncuBlanket kit is safe, non-electric, and reusable. This kit consists of a blanket
which has been specially designed to accommodate an infant. This blanket provides instant
warmth to assist in maintaining an infant’s body temperature (between 97.5-99.5ºF (36.4-
37.5ºC)) by using an InstaWarmer pack which is installed in the back zipper pocket.
Specications for Preterm IncuBlanket and InstaWarmer:
Total Weight: 5 lbs (2.3 kg)
IncuBlanket Weight: 1.1 lbs (0.5 kg)
IncuBlanket Dimensions: 17.5 in x 10 in x 2.5 in
(44.45 cm x 25.4 cm x 6.35 cm)
InstaWarmer Weight: 3.9 lbs (1.8 kg)
InstaWarmer Dimensions: 16 in x 9 in x 1 in
(40.6 cm x 22.8 cm x 2.5 cm)
Peak Temp: 102.2°F (39°C)
Time Duration: 5-8 Hours
Product Description
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2
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InstaWarmer
IncuBlanket
IncuBlanket Kit User Manual Page 4
Use Instructions (Visual Guide)
The Warmilu IncuBlanket is intended to assist in maintaining an
infant’s core body temperature for 5-8 hours. Upon receiving the
Warmilu IncuBlanket, please check to make sure you have received
its two components including:
Newborns, infants, preterm infants, and young children are more likely
to develop hypothermia. Neonates particularly low birth weight infants
(2,500 g or less), very low birth weight infants (1,500 g or less),
extremely low birth weight infants (less than 1,000 g), and preterm
infants (<37 weeks) are more likely to develop hypothermia due
to limited capacity to thermoregulate. Infants up to about 32 weeks
of gestation do not have the ability to warm themselves effectively. Normal infants weigh
2,500 - 4,200 g at term delivery. Infants risk hypothermia if they are left in close proximity to
cold surfaces, are stressed, or exposed to room temperature air and if the infant is not
immediately dried and swaddled to prevent evaporative, conductive, and convective heat
losses. Hypothermia may be caused by environmental factors, disorders that impair
thermoregulation (i.e. sepsis, intracranial hemorrhage, drug withdrawal, and/or combinations
of the above). The World Health Organization suggests different temperature values to assess
the degree of hypothermia in infants:
Risk factors for hypothermia in infants include maternal hypertension, Cesarean section,
and low Apgar scores. IncuBlankets and InstaWarmers may be used on infants weighing
2,500 g or less. Babies keep a normal heart rate when their body temperature is between
36.7-36.8°C.
1) InstaWarmer: Warmilu warming pack
2) IncuBlanket: Warmilu infant warming blanket.
Cold stress or mild hypothermia: 36.0°C to 36.4°C (96.8°F - 97.5°F)
Moderate hypothermia: 32.0°C to 35.9 C (89.6°F to 96.6°F)
Severe hypothermia: <32°C (89.6°F)
Source: Merck Manual 2017. http://www.merckmanuals.com/professional/pediatrics/perinatal-problems/hypothermia-in-neonates
Intended Use
IncuBlanket Kit User Manual Page 5
IncuBlanket
InstaWarmer
Warmilu IncuBlanket Clinical Trials
Clinical trials were conducted January – March 2013 at the Kempegowda Institute of Medical
Sciences (KIMS) in Bangalore, India. The IncuBlanket kept 20 low birthweight and preterm
infants warm between 36.4°C – 37.5°C. (97.5°F – 99.5°F) for 5 hours and sucessfully
prevented hypothermia. The average weight of the infants was 1.75 kg (range 1.3 kg – 2.4 kg)
and average gestational age 35.25 weeks (range 31-38 weeks). The trial was conducted on 10
boys and 10 girls. There was no case of overheating, skin rashes, hypothermia,
hyperthermia, or erythema of signicance noticed during or immediately after the study
period. The interior temperature of the IncuBlanket will not exceed 39ºC.
The Warmilu IncuBlanket and InstaWarmer have successfully cleared the Kenya Pharmacy
and Poisons Board. Application Number: 9737.
The Warmilu InstaWarmer is a registered FDA Class I reusuable device.
The Warmilu is in the process of ling for USA FDA 510(k) clearance and CE Mark for the
IncuBlanket and InstaWarmer.
IncuBlanket Kit User Manual Page 6
Step 1: To boil your pack, ll a medium to large sufuria (metal pot) with enough water to com-
pletely cover the InstaWarmer, and heat until it begins to boil. Reduce heat. Step 2: Roll your
pack into thirds and carefully place into the boiling water. Step 3: Boil the pack. The length of
time needed to reset your pack by boiling is determined by your altitude. Please refer to the
image below to nd the correct boiling time for your location.
Step 4: Stir the pack several times during the boiling process to ensure all of the warming
solution is heated, and that the pack does not stick to the sufuria (metal pot). Step 5: When
the pack has nished boiling, remove it from the water and check to make sure the entire
contents of the pack have become a clear liquid. If white crystals are observed, continue
boiling for another 5 minutes, then check again. CAUTION: PACK WILL BE HOT, USE A
PLASTIC OR WOOD UTENSIL TO REMOVE IT FROM THE WATER. Once the pack has
cooled to room temperature, you will see two distinct materials within the pack: 1) The clear
liquid phase-change material 2) The semi-solid thermal buffer that is an semi-transparent
white color. Step 6: Before use, the pack MUST BE COOLED TO ROOM TEMPERATURE.
Lay the boiled pack at with the activator disk slightly lower than the rest of the pack (such as
off the edge of a counter or shelf). Once the pack feels room temperature to the touch (ap-
proximately 25°C), it is ready for use. Packs can be stored for up to 1 year, and used when
needed.
To watch a video on how to boil the pack, visit:
https://www.youtube.com/watch?v=qnYURGBWICI
IncuBlanket Kit User Manual Page 7
Resetting Option 1: Boiling Your InstaWarmer
Using Your InstaWarmer
The InstaWarmer is activated before shipping to help prevent damage. When you receive your
InstaWarmer pack you will need to reset it before use by boiling or autoclaving.
When you are ready to use your InstaWarmer pack, lay it on a surface and grasp the metal
activator disk (located in one corner of the pack) between both thumbs. Click it a few times to
activate the phase change and generate heat. You will hear a clicking sound. The liquid in the
pack will begin turning into a solid. You will feel warmth in seconds. Knead the InstaWarmer
for 30 seconds to evenly distribute the thermal buffer before using the InstaWarmer in the
IncuBlanket. If you experience any difculty 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 Your InstaWarmer Pack
IncuBlanket Kit User Manual Page 8
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Activator Disk
Resetting Option 2: Autoclaving Your InstaWarmer
The InstaWarmer pack can be reset in a hospital autoclave as an alternative to boiling. Step
1: Wipe InstaWarmer clean with soap and water. Step 2: Wrap InstaWarmer in a sterlization
pouch or autoclave wrap.
Autoclave Settings: Use gravity cycle at 121ºC for 15 minutes, and a 15 minute dry time.
IncuBlanket Kit User Manual Page 9
Prepping and Using the IncuBlanket
Unzip the back pocket of your IncuBlanket.
Zip the pocket closed completely.
Place your InstaWarmer in the pocket.
DO NOT USE THE INSTAWARMER IMMEDIATELY AFTER BOILING. IT
MUST BE ALLOWED TO COOL TO ROOM TEMPERATURE BEFORE
ACTIVATING.
Flip the blanket so the pack is on the bottom. Open the blanket.
Place the infant into the blanket on their back. Make sure the infant’s head
is in a neutral position, and their legs and hips are in a relaxed, exed
position. Fold the leg pouch over the infant’s torso.
Fold the right wing across the infant’s body. Repeat with the left wing
and clip buckle. Pull the nylon strap down the tighten aps. Make sure
the blanket is closed snuggly around the infant, but that they are able to
breathe freely.
Step 1:
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Step 2:
Step 3:
Step 4:
Step 5:
Step 6:
IncuBlanket Kit User Manual Page 10
Positioning the Infant
Completely open blanket aps before placing infant. Place infant in the blanket on their back
with head at end A and feet pointing towards end B. The infant’s head should be in a neutral
position and their airway must be clear and unblocked. Their legs and hips should be in a
relaxed, exed position. When infant is correctly positioned, fold leg pouch up over infant, and
close wings. Make sure infant is able to breath freely.
A
B
Leg Pouch
Wing
Wing
IncuBlanket Kit User Manual Page 11
Remove the InstaWarmer pack from the back pocket of your IncuBlanket, and leave the
pocket unzipped. Open blanket aps. Hand wash: Wash in hot water (a minimum of 160ºF or
70ºC) by hand for a minimum of 25 minutes with mild detergent. Agitate frequently. Machine
wash: wash on normal cycle on hot with mild detergent. DO NOT BLEACH. Machine dry on
low heat or hang dry. Store in clean, dry location.
DO NOT wash the InstaWarmer in the washing machine; wipe down with sanitizing solution
and rinse with water. Do not use acetone to clean your InstaWarmer. Return to ready-to-acti-
vate liquid state by boiling before storing. Store out of direct sunlight in clean, dry location.
Caring for your IncuBlanket
Washing your InstaWarmer
INSTAWARMER
WIPE DOWN ONLY
INCUBLANKET
WASHABLE
Caring for your IncuBlanket and InstaWarmer
IncuBlanket Kit User Manual Page 12
Materials are all 100% non-toxic. All materials are made in the USA.
All components are assembled and manufactured in Ann Arbor, MI, in the United States.
This product does not contain any rubber or latex.
External fabric:
64% polyester, 36% polyurethane
CPSIA certied
Contains no lead, BPA, phthalates or other harmful chemicals
Lining fabric:
Face: 70% bamboo viscose, 30% organic cotton
Back: wicking polyester
CPSIA certied
Contains no lead, BPA, phthalates or other harmful chemicals
Batting fabric one:
65% olen, 35% polyester
Batting fabric two:
93.75% polyester and 6.25% metalized polyethylene lm
External exible polymer lm:
100% medical grade polyurethane
Latex Free
Pack contents:
Non-toxic materials
Metal disk
IncuBlanket Materials
InstaWarmer Materials
IncuBlanket Information
IncuBlanket Kit User Manual Page 13
All intellectual property belongs to Warmilu LLC. Warmilu reserves the right to make
changes to the specications 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 IncuBlanket and InstaWarmer when treating a particular patient. Warmilu does not
dispense medical advice and recommends that medical professionals be trained in the
use of the IncuBlanket and InstaWarmer before using it with a patient. Do not use the
IncuBlanket and InstaWarmer on infants without rst seeking advice from a medical
professional.
a. When boiling your InstaWarmer, do not grab pack directly or touch the sufuria (metal pot) or
boiling water. 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. If pack contents
come in contact with skin, rinse immediately 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.
c. Monitor infant’s temperature frequently while using the IncuBlanket. Temperature can be
monitored with an external thermometer. If infant’s core body temperature reaches 38°C or
above and does not return to a safe range within 30 minutes, remove infant from blanket. Do
not place infant directly on InstaWarmer.
d. Follow proper cleaning and sanitizing instructions for your IncuBlanket and InstaWarmer to
prevent cross infection or damage to the product.
e. Do not use IncuBlanket on infants who are febrile, having seizures, at risk for respiratory or
cardiac arrest, have a brain injury, or are experiencing internal hemorrhage.
f. Only activate the InstaWarmer once it has completely cooled to room temperature to
prevent over heating.
Safety
Disclaimer
Table of contents
