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OPERATION

MANUAL

AN AWARD WINNING, AFFORDABLE INFANT WARMER

Disclaimer
All rights reserved. Embrace Innovations reserves the right to revise specifications and
features shown herein, or discontinue the product described herein at any time without
prior notice or obligation. Contact your Embrace Innovations representative for the most
current information. The contents of the document are provided as is. Please check
with Embrace Innovations on the most current information. Embrace Innovations is a
registered trademark of Embrace Innovations. Other products and company names
mentioned herein may be trademarks of their respective owners.

Table of Contents
ABOUT THE COMPANY ................................................................................................................. 4
OVERVIEW........................................................................................................................................... 4
COMPANY CONTACT INFORMATION .................................................................................................. 4
ABOUT THE PRODUCT .................................................................................................................. 4
INTENDED USE AND CONTRAINDICATIONS ........................................................................................ 4
DECLARATION OF SUBSTANCES USAGE .............................................................................................. 4
ABOUT THIS MANUAL .................................................................................................................. 5
SAFETY PRECAUTIONS ......................................................................................................................... 5
DECLARATION OF LANGUAGE TRANSLATION ..................................................................................... 5
INTENDED USERS ................................................................................................................................ 5
USER RESPONSIBILITY ......................................................................................................................... 5
CUSTOMER SERVICE INFORMATION ................................................................................................... 6
CHAPTER 1: INTRODUCTION ......................................................................................................... 7
CHAPTER 2: USES AND APPLICATION ............................................................................................ 9
2.1 IN-CLINIC USAGE ........................................................................................................................... 9
2.2 TRANSPORT USAGE ....................................................................................................................... 9
CHAPTER 3: PRODUCT DESCRIPTION........................................................................................... 10
3.1 PRODUCT OVERVIEW .................................................................................................................. 10
3.2 ACCUTEMP HEATER .................................................................................................................. 11
AccuTemp Heater design features ............................................................................................. 11
AccuTemp Heater user interface ................................................................................................ 12
3.3 WARMPAK ................................................................................................................................ 13
WarmPak design features .......................................................................................................... 13
WarmPak user interface............................................................................................................. 15
3.4 WARMPAK TEMPERATURE INDICATOR .................................................................................... 16
WarmPak temperature indicator design features ..................................................................... 16
WarmPak temperature indicator user interface ........................................................................ 16
3.5 BABYWRAP ............................................................................................................................... 18
BabyWrap design features ......................................................................................................... 18
BabyWrap user interface............................................................................................................ 19
CHAPTER 4: SAFETY INSTRUCTIONS AND ERROR INDICATORS ..................................................... 21
4.1 WARNINGS AND CAUTIONS ON THE EQUIPMENT ...................................................................... 21
4.2 GENERAL EMBRACE NEST SAFETY INSTRUCTIONS ................................................................... 21
4.3 SAFETY INSTRUCTIONS FOR ACCUTEMP HEATER ..................................................................... 21
4.4 ERROR INDICATORS FOR THE ACCUTEMP HEATER ................................................................... 22
4.5 SAFETY INSTRUCTIONS FOR WARMPAK ................................................................................... 23
4.6 SAFETY INSTRUCTIONS FOR BABYWRAP .................................................................................. 25
CHAPTER 5: OPERATING THE WARMER....................................................................................... 26
5.1 CHECKING EQUIPMENT BEFORE USE .......................................................................................... 26
5.2 GETTING READY........................................................................................................................... 26
5.3 USING THE EMBRACE NEST ...................................................................................................... 27
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Setting up the AccuTemp Heater................................................................................................ 27


Starting the heating cycle ............................................................................................................. 27
Removing the heated WarmPak from the AccuTemp Heater ................................................. 29
Ever-ready mode: Keeping the WarmPak warm in the AccuTemp Heater ............................. 29
Setting up the WarmPak in the BabyWrap ............................................................................. 30
Preparation of the newborn .......................................................................................................... 30
Setting up the BabyWrap ........................................................................................................... 31
Monitoring the newborn inside the BabyWrap.......................................................................... 32
CHAPTER 6: CLEANING, MAINTENANCE AND STORAGE ............................................................... 33
6.1 CLEANING .................................................................................................................................... 33
AccuTemp Heater ....................................................................................................................... 33
WarmPak.................................................................................................................................... 33
BabyWrap................................................................................................................................... 34
6.2 MAINTENANCE & STORAGE ........................................................................................................ 35
AccuTemp Heater ....................................................................................................................... 35
WarmPak.................................................................................................................................... 35
BabyWrap................................................................................................................................... 35
6.3 PERIODIC CALIBRATION CHECK ................................................................................................... 36
6.4 PERIODIC REPLACEMENT OF THE WARMPAK ........................................................................... 36
TECHNICAL SPECIFICATIONS ....................................................................................................... 37
ACCUTEMP HEATER........................................................................................................................ 37
WARMPAK ...................................................................................................................................... 37
WARMPAK TEMPERATURE INDICATOR .......................................................................................... 38
BABYWRAP ..................................................................................................................................... 38
MATERIAL SAFETY SPECIFCATIONS ............................................................................................. 39
PCM ................................................................................................................................................... 39
HAZARDS IDENTIFICATION ............................................................................................................ 39
FIRST AID MEASURES .................................................................................................................... 39
TOXICOLOGICAL INFORMATION .................................................................................................. 39
BABYWRAP INNER LINING MATERIAL ............................................................................................ 40
WATER LAYER .................................................................................................................................... 40
LIMITED WARRANTY .................................................................................................................. 41
GLOSSARY OF TERMS ................................................................................................................. 43

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ABOUT THE COMPANY


OVERVIEW
Embrace Innovations provides a line of innovative, affordable and high quality healthcare products.
The Embrace Nest was designed in the U.S. and has received numerous international awards,
including recognition in TIME magazine.
You can find out more at www.embraceinnovations.com

COMPANY CONTACT INFORMATION


Postal Address:
Cambree Life Improvement Technologies Pvt. Ltd.
(100% subsidiary of Embrace Technologies, Inc.)
#18/19, Platinum Square, 2nd Floor
Leonard Lane, Richmond Town
Near Johnson Market
Bangalore 560025
Email Address: sales@embraceinnovations.com or info@embraceinnovations.com
Customer Helpline (toll free): 1800 1033 123

ABOUT THE PRODUCT


INTENDED USE AND CONTRAINDICATIONS
Embrace Nest is intended to provide warmth to clinically stable newborns weighing between 1.5 to
2.5 kilograms. Embrace Nest is designed for use by clinically trained caregivers as an infant warmer
in the clinic, or during transport.
The Embrace Nest is NOT intended to be used by untrained caregivers, or outside of clinical
settings, or sent home with the parents. The product is also not intended to be used on clinically
unstable newborns or on newborns outside of the above specified weight range.

DECLARATION OF SUBSTANCES USAGE


The Embrace Nest is a non-invasive device in which only the BabyWrap comes into contact with
the human body. The product does not include any bio-substances or tissue derivatives.
The product does not need to be sterilized before use.

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ABOUT THIS MANUAL


This manual describes the features and operation of the Embrace Nest. It is important to read it
completely and have a thorough understanding of the product operations to avoid possible risk or
injury to the patient and user.
Note that the illustrations shown in the manual are only indicative of key features of the product,
and not an exact graphical reproduction.

SAFETY PRECAUTIONS
Please take good note of all Warnings, Caution and Notes provided in this manual before using the
equipment. The terms WARNING, CAUTION and NOTES have specific meanings in this manual.

CAUTION
CAUTION advises against actions or situations that could damage equipment or produce inaccurate
measurements or invalidate a procedure, although personal injury is unlikely.
WARNING
WARNING advises against certain actions or situations that could result in serious personal injury.
NOTE
NOTE provides useful additional information regarding a function or procedure.

DECLARATION OF LANGUAGE TRANSLATION


The Embrace Nest comes to you as a package, complete with labels, user manuals and related
documents, all which are in English. The product targets doctors and nurses who are proficient in the
language, and can read and understand the instructions.

About the User


INTENDED USERS
This product should only be operated by personnel trained in its operation and familiar with the risks
and benefits of this type of device. This product is to be operated only by clinically trained
caregivers.
WARNING
Under no circumstances should the Embrace Nest be lent or rented to parents of low birth weight
newborns for use at home. Using the product without medical supervision exposes the newborn and
the user to risk of injury or death.

USER RESPONSIBILITY
This product must not be altered or used for any purpose other than as described in this manual.
The individual components of the Embrace Nest (as described in CHAPTER 1: INTRODUCTION) must
only be purchased as refills, once the Starter Pack has already been purchased.

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This product will perform in conformity with the description contained in this manual and
accompanying labels and/or inserts when assembled, operated, maintained, and repaired in
accordance with the instructions provided.
This product must be checked before use. A defective product should not be used. Parts that are
broken, missing, plainly worn, distorted, or contaminated should be replaced immediately. Should
such repair or replacement become necessary, Embrace Innovations recommends that a telephone
or written request for service advice be made to Embrace Innovations.

CUSTOMER SERVICE INFORMATION


Embrace Innovations Customer Service
#18/19, Platinum Square, 2nd Floor
Leonard Lane, Richmond Town
Near Johnson Market
Bangalore 560025
Customer Helpline: 1-800-1033123
The user of this product shall bear the sole responsibility for any malfunction that results from
improper use, faulty maintenance, improper repair, damage, or alteration by anyone other than
authorized personnel.

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CHAPTER 1: INTRODUCTION
The Embrace Nest is an innovative, affordable and easy to use solution for warming of clinically
stable premature and low birth weight (LBW) newborns. Specifically, the Embrace Nest can be
used either as:
1. An in-clinic warming solution
2. In facilitating transport of LBW newborns between or within sites of care
Embrace Nest is intended to provide warmth to clinically stable newborns weighing between 1.52.5 kilograms. Embrace Nest is designed for use by clinically trained caregivers as an infant warmer
in the clinic, or during transport.
The Embrace Nest is NOT intended to be used by untrained caregivers, or outside of clinical
settings, or sent home with the parents. The product is also not intended to be used on clinically
unstable newborns or on newborns outside of the above specified weight range.
The Embrace Nest consists of three components:

BabyWrap

An interface in which the


newborn rests

WarmPak

A removable pack of phasechange material (PCM) and


water which, when heated,
serves as the source of
warmth

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AccuTemp Heater

A precision conduction
heater that heats the
WarmPak to the
operating temperature
before every use

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The WarmPak is placed in a compartment of the BabyWrap that is separate from, but in thermal
contact with the newborn. The WarmPak and BabyWrap work together to maintain a warm
microclimate around the newborn while also providing the newborn warmth through dorsal thermal
conduction.
Once heated, the WarmPak maintains a temperature of ~37C for at least 4 hours 1 without the
need to be reheated. This is the same temperature range as recommended by the World Health
Organization (WHO) for a heated water mattress 2.

WarmPak Temperature Performance

Temperature stays at ~37C for at least 4 hours


(when ambient temperature is 25C or higher)

The Key Features of Embrace Nest are:


Maintains a temperature of ~37C for at least 4 hours1
Does not require a constant supply of electricity
Ensures no electricity near the newborn
Enables mother-to-child bonding
Portable for in-clinic or transport usage

Reusable and easy to sanitize

duration of at least 4 hours when ambient temperature is 25 C or higher


WHO reference number: WS 420 97TH Thermal protection of the newborn: a practical guide

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CHAPTER 2: USES AND APPLICATION


Embrace Nest is intended to provide warmth to clinically stable newborns weighing between 1.5 to
2.5 kilograms. Embrace Nest is designed for use by clinically trained caregivers as an infant warmer
in the clinic, or during transport.
This product is designed to be used in clinics under medical supervision and not, in any
circumstances, be lent to parents of low birth weight or healthy newborns for use at home.
The Embrace Nest can be used to provide warmth to newborns in the following scenarios:

2.1 IN-CLINIC USAGE

To provide warmth to clinically stable pre-term and low birth weight newborns 3 in a clinical setting:

In rooms where the ambient temperature is low

After C-section deliveries

On examination tables

In maternity wards before discharge

To enable mother-to-child bonding while providing warmth

2.2 TRANSPORT USAGE


When transferring newborns between different settings of care, or within the same setting of care:
Inter-hospital usage: For transport from the site of birth (maternity clinic, nursing home) to referral
hospitals / tertiary care hospitals.
Intra-hospital use: Transfers between Neonatal Intensive Care Unit (NICU), x-ray , scan and MRI
facilities, or maternity wards.

NOTE
It is recommended that the Embrace Nest is to be used only when the ambient temperature is
between 10 to 34 C, as higher temperatures may not necessitate the use of additional warming.
The use of the Embrace Nest contrary to these recommendations is ultimately at the doctors
discretion.

clinically stable newborns weighing between 1.5 to 2.5 kilograms

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CHAPTER 3: PRODUCT DESCRIPTION


The Embrace Nest starter pack consists of the components listed below. Check the contents upon
unpacking and verify that all components are available. Check for any damage that may have
occurred during shipping.
Product

Quantity

AccuTemp Heater

WarmPak

BabyWrap + cushion

1+1

Instructional Poster

Operation Manual

WarmPak Bag

The following section provides an overview of the Embrace Nest with a brief functional description
of each of the above components.

3.1 PRODUCT OVERVIEW


As stated earlier, the Embrace Nest consists of three components: AccuTemp Heater, WarmPak
and BabyWrap.
The AccuTemp Heater is used to heat the WarmPak to operating temperature (defined below).
This heated WarmPak serves as the source of warmth in the Embrace Nest.
The BabyWrap serves as an interface to ensure good thermal contact between the newborn and
the WarmPak, and to offer additional insulation to the ventral surface of the newborn.
The heated WarmPak is inserted into the WarmPak compartment of the BabyWrap. The
newborn is secured in the newborn compartment of the BabyWrap. The device (heated
WarmPak + BabyWrap) thus prepared may now be used to provide thermoregulatory support to
the newborn.
For in-clinic usage, it is recommended to use two WarmPaks in tandem, one after the other (one
being warmed in the AccuTemp Heater, while the other is being used on the newborn). This way
the newborn can be provided with a continuous supply of heat.

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3.2 ACCUTEMP HEATER


The AccuTemp Heater warms the
WarmPak to the operating temperature 4.
This is the only component of the Embrace
Nest that requires access to an AC power
source. It can however also be run off of a
generator or any alternate AC power source
that can provide a 230 V AC supply.

AccuTemp Heater design features


The AccuTemp Heater uses a sophisticated proportional control mechanism to ensure the
WarmPak is heated to the operating temperature (between 37 C and 40 C) and is not, under any
circumstances, overheated (greater than 41 C).
Under normal operating conditions 5 it takes approximately 35 minutes for the AccuTemp Heater to
heat the WarmPak to the operating temperature.

Automatically resumes heating in case of power outage

Ever-ready technology ensures heated WarmPak always ready for use

Simple one-button operation

Built-in safety features

It is engineered to operate with minimal maintenance and is robust enough to withstand most
power surges and fluctuations.
In the case of a deviation from regular operation, the AccuTemp Heater will inform the user of an
error through its inbuilt alarms and indicators. For more information on safety features and alarms,
please refer to 4.3 SAFETY INSTRUCTIONS FOR ACCUTEMP HEATER and 4.4 ERROR INDICATORS
FOR THE ACCUTEMP HEATER.

NOTE
Heating times will vary with varying input voltage. In brown out conditions with lower voltage
supply, the heating cycle may take significantly longer than 35 minutes.
Heating times will also vary as the WarmPak ages, and the water level in the WarmPak is
reduced. Heating cycle may take significantly longer than 35 minutes.

4
5

See Glossary for definition of operating temperature


See Glossary for definition of normal operating conditions

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WARNING
It is important to only use the Embrace AccuTemp Heater to warm the WarmPak in order to
avoid over-heating of the WarmPak. Do not use any other method to heat up the WarmPak.

AccuTemp Heater user interface


The Start/Stop button should be pushed to initiate the heating cycle, when the user wants to heat
up the WarmPak. The same button can be used to interrupt the heating cycle.
The progress of the heating cycle is monitored using the two indicators on the lid that indicate when
the heating cycle is in progress and when the WarmPak is ready. The amber HEATING CYCLE ON
indicator will light up when the heating process is on.
The clear viewing window allows the user to perform a quick visual check on the progress of heating.
Once ready, the AccuTemp Heater will beep two times once when ready, and once a minute after
being ready. The green WARMPAK READY indicator will remain illuminated.
The AccuTemp Heater will provide heat to maintain the WarmPak at the operating temperature,
as long as the AccuTemp Heater remains switched on and the green Ready indicator is still
illuminated.
In case of a power outage, the AccuTemp Heater automatically resumes its heating cycle when the
power returns.

NOTE
Pressing the Start/Stop button or opening the lid will turn off the AccuTemp Heater cycle and the
cycle must be re-initiated (by pressing the button again) in order to maintain the WarmPak
temperature. Refer to the figure below.
Start/Stop Button - Push this button to start or
stop the heating cycle.
HEATING CYCLE ON
Indicator - This indicator
glows amber to indicate
heating cycle is in
progress.
POWER ON Indicator - This
indicator glows blue to
indicate unit is receiving AC
mains supply.

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WARMPAK READY Indicator - This indicator


glows green when the WarmPak has reached
operating temperature and is ready to use.

Sliding Latch- Push this


sideways to open the lid of
the AccuTemp Heater.
Viewing Window Transparent window to
observe the progress of
WarmPak heating.

3.3 WARMPAK
The WarmPak absorbs heat from the AccuTemp
Heater, and slowly releases this heat over a period
of time to the newborn, when placed in the
BabyWrap. Under normal operating conditions,
over a period of at least 4 hours, the WarmPak
will provide a warm surface for the newborn to lie
on. Once heated there is no need of power supply
to provide warmth. The WarmPak thus provides a
passive source of heat to the newborn, without any
electricity near the newborn.

WarmPak design features

The WarmPak is made of heat resistant polyurethane. It has two compartments: one
containing PCM and the other containing water.

When the WarmPak is heated using the AccuTemp Heater the PCM melts and stores
energy. When the heated WarmPak is placed inside the BabyWrap, it slowly releases the
stored heat energy to the newborn, through the water layer.

The PCM has been specially engineered to release or absorb heat at the operating
temperature.

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The water layer eliminates the presence of hotspots, and thus provides a surface of uniform
heat to the newborn.

Several safety features have been engineered into the WarmPak:

The polyurethane cover has a high melting point in excess of 120 oC and is at no risk of
melting, as the temperature of the AccuTemp Heater surface does not rise beyond 85o C
during normal operation.

The WarmPak does not have any electrical circuits providing an additional element of
safety from electrical hazards.

The WarmPak is a passive heat source, thus once heated and removed from the AccuTemp
Heater, it cannot get any hotter, thus greatly mitigating the risk of overheating the newborn.
Some other unique design features of the WarmPak are:

User-friendly indicator displays WarmPak readiness

Certified non-toxic materials

Convenient SIM-card design for ease of orientation

NOTE
The heat-providing capacity of the WarmPak, mentioned here and elsewhere in the document,
depends on factors such as weight and health of the newborn and operating conditions.
The WarmPak, when in the BabyWrap, has been proven through bench tests to maintain the
operating temperature for at least four hours at an ambient temperature of 25 C.
Lower ambient temperatures may cause faster heat loss from the WarmPak, thereby reducing the
usable duration.
Embrace Innovations recommends that the user must bear in mind all these factors when using the
WarmPak and periodically check the temperature indicator of the WarmPak and closely monitor
the vital signs of the newborn placed in the BabyWrap.

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WarmPak user interface


The SIM-card shaped
WarmPak makes it
easy to align it in the
right position inside the
AccuTemp Heater.

The WarmPak
Temperature Indicator
indicates to the user if
the WarmPak can be
used or if it needs to
be reheated.

The SIM-card shape also serves


to help the user in correctly
orienting the WarmPak when
placing it into the BabyWrap.

Embrace Nest Operation Manual (0602-50001-002)

The WarmPak has two layers


a water layer and the PCM layer.
Whenever placing the
WarmPak either into the
AccuTemp Heater, or into the
BabyWrap, ensure that the
water layer is facing up.

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3.4 WARMPAK TEMPERATURE INDICATOR


The WarmPak contains a WarmPak temperature indicator at the bottom left hand corner. The
function of the WarmPak temperature indicator is to alert the user to the feasibility of use of the
WarmPak.

WarmPak temperature indicator design features


The temperature indicator has been positioned such that it will be visible to the user ONLY when the
WarmPak is correctly inserted into the BabyWrap, as seen below.
The WarmPak temperature indicator alerts the user to potentially hazardous situations, if the user
has over-heated the WarmPak. The indicator also serves to indicate to the user when the
WarmPak is at the right temperature and may be used, and when it has run out of stored heat, and
needs to be reheated.

WarmPak temperature indicator user interface


The WarmPak temperature indicator will display one of three states:

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OK TO USE STATE: When the WarmPak is within the correct operating temperature range,
the temperature indicator bar will be in the OK region as shown on the left. This indicates that
the WarmPak is ready to use, and can be placed into the BabyWrap.

TOO COLD STATE: When the WarmPak has given up all the stored heat energy, and drops
below the operating temperature threshold, the temperature indicator bar will be in the TOO
COLD region as shown on the left. This indicates that the WarmPak has run out of energy,
and must be immediately removed from the BabyWrap. The WarmPak will need to be
recharged in the AccuTemp Heater before it can be re-used.

TOO HOT STATE: There is a third state that will not be seen if the WarmPak is used
correctly as indicated with the AccuTemp Heater.
In the event that the heater malfunctions due to improper use, or an alternate heating method
is used to heat the WarmPak, the WarmPak temperature may rise above 41 C. The
WarmPak indicator will be as shown on the left.
This indicates to the user that the WarmPak is too hot to be used, and under no
circumstances should the WarmPak be used, if the overheating indicator is displayed.

WARNING
It is important to pay careful attention to the WarmPak temperature indicator. The WarmPak
must be used only if the temperature indicator indicates that the WarmPak is ready for use.
When in use for warming newborns, it is important to observe the temperature indicator at regular
intervals (every 30 minutes) to ensure that the WarmPak is within the operating temperature.

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3.5 BABYWRAP
The BabyWrap has compartments that hold
the newborn and the heated WarmPak, and
ensure that the two are in good thermal contact
with each other. The BabyWrap also traps the
heat from the WarmPak and provides a warm,
insulating microclimate to the newborn.
The contour of the BabyWrap fits snugly
around the newborn and the tapered ends
prevent accidental slipping. The spacious,
insulated hood region minimizes risk of
suffocation, while at the same time controlling
heat loss through the head.
The BabyWrap has been engineered to minimize heat loss from the WarmPak to the
surroundings, thus ensuring that the WarmPak stays effective for a long time.

BabyWrap design features

The BabyWrap is reusable and easy to sanitize with a disinfecting cotton swab.

The WarmPak compartment is heavily insulated on the outside to minimize heat loss from
the WarmPak. The flaps that cover the newborn also are sufficiently insulated so as to
minimize heat loss, and trap the heat, creating a warm microclimate for the newborn.

The WarmPak compartment is also made of waterproof material. In the event the
WarmPak were to develop a leak, the newborn would be protected from being exposed to
the contents of the WarmPak.

The thin fabric between the newborn and the WarmPak compartment facilitates maximum
heat transfer from the WarmPak to the newborn in the BabyWrap.

The newborn compartment is made of fluid-proof, bacteria-resistant, skin-safe TPU fabric.

The inner surface of the newborn compartment has been designed to minimize seams, and
potential dirt traps.

The BabyWrap is compatible with oxygen and IV lines. It also has an observation window
to facilitate newborn monitoring.

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BabyWrap user interface

Hood- The hood is meant to insulate the


head and control heat loss from the
head.
Observation widow- The observation
window provides a view of the newborn
inside the BabyWrap. The medical staff
can monitor the newborns breathing,
skin color and general movement
through this window.
Adjustable Straps- The adjustable straps
help secure the flaps in position. The
flaps allow the user to accommodate
newborns of different girths, by suitably
adjusting the flaps.

Pillow: A pillow is provided


to cushion the head of the
newborn.
Newborn Compartment- A
compartment to place a
newborn and secure it in
the BabyWrap.
WarmPak CompartmentAn insulated compartment
to place the heated
WarmPak. The
compartment can be
opened and closed with a
zip.
WarmPak temperature
indicator window- Once the
WarmPak is inserted correctly
into the BabyWrap, the
WarmPak temperature
indicator can be seen through
this window. The user can
monitor the temperature of the
WarmPak through this
window.

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WARNING
Do not use the BabyWrap if the fabric is torn, or if the insulation is spilling out.
Always ensure that the BabyWrap is washed thoroughly between uses across different babies.
Always periodically sanitize the interior surface of the BabyWrap compartment to mitigate the risk
of accumulation of dirt and bacterial contaminants.

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CHAPTER 4: SAFETY INSTRUCTIONS AND ERROR INDICATORS


It is important to understand and follow certain safety measures before using the Embrace Nest.
The precautions mentioned below are to prevent possible risk of injury to the patient or the
operator and ensure correct usage of the device.

4.1 WARNINGS AND CAUTIONS ON THE EQUIPMENT


Note carefully the various warning, caution and information labels that have been placed on the
AccuTemp Heater, WarmPak and BabyWrap.

4.2 GENERAL EMBRACE NEST SAFETY INSTRUCTIONS

Read this user manual before using the device.

Read all labels/warnings/cautions on the AccuTemp Heater, WarmPak and BabyWrap


before use.

Do not attempt to use the device if an error indicator is displayed or if any component is
damaged.

Do not heat the WarmPak in any way other than described here.

Replace any part that is worn out. Replace WarmPak after 6 months from date of first use

Monitor the vital signs (such as body temperature, skin color, breathing) of the newborn in the
BabyWrap at regular intervals.

Remove the newborn when the temperature of the WarmPak drops below the operating
temperature.

Sanitize the WarmPak and the BabyWrap before every use as described in instructions for
cleaning in 6.1 CLEANING.

4.3 SAFETY INSTRUCTIONS FOR ACCUTEMP HEATER

Only trained professionals, who have read this manual thoroughly should operate The
AccuTemp Heater

Do not attempt to use the AccuTemp Heater if an error is indicated (see 4.4 ERROR
INDICATORS FOR THE ACCUTEMP HEATER)

Do not open the lid during the heating process. Touching the heating surface during the heating
process may cause burn injury.

Use a dry cloth to clean the AccuTemp Heater. Do not pour water on the unit or immerse the
unit in water.

Keep the AccuTemp Heater away from exposure to external heat sources, sunlight, or rain.

Only use the AccuTemp Heater to heat the WarmPak. Heating any other substance or using it
inappropriately may damage the equipment and/or cause injury to the user.

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Check the electrical cords for exposed wires before using the AccuTemp Heater. Do not tamper
with the grounding pin of the power outlet. Tampering with the electronics or electrical
components of the unit may result in hazards to the user and/or cause the unit to malfunction.

The temperature performance of the unit is critically dependent on the temperature sensor on
the lid. Do not tamper with this sensor and ensure that it is cleaned periodically.

Ensure that the AccuTemp Heater is adequately packed when transporting the device.

Do not use the AccuTemp Heater if it is cracked or broken.

Unplug the AccuTemp Heater when it is not in use and store it in a cool, dry place.

Always use authorized technical assistance for repairing the AccuTemp Heater.

Check the calibration of the Heater every six months as described in 6.3 PERIODIC CALIBRATION
CHECK

Make sure the AccuTemp Heater is unplugged when replacing the fuse.

4.4 ERROR INDICATORS FOR THE ACCUTEMP HEATER


Upon switching on, the AccuTemp Heater will exist in one of the three modes below:
AccuTemp Heater works correctly:
When the AccuTemp Heater is switched on, all three LEDs will light up, and buzzer will beep for
one second. The Heater performs a self-check routine on itself. If the AccuTemp Heater finds that
all internal systems are working correctly, it will transition to the POWER ON state. This is indicated
by the absence of any audio alarm, and the presence of an illuminated blue POWER ON indicator.
AccuTemp Heater displays a malfunction error:
In the case of a malfunction error detected either during startup or during regular operation, the
AccuTemp Heater will indicate this to the user by means of an intermittent beeping sound. In
addition to the beeping, all the three icons POWER ON (blue), HEATING CYCLE ON (amber) and
WARMPAK READY (green) will keep flashing.
This indicates that the AccuTemp Heater has malfunctioned, and will need to be replaced or
repaired. If alerted to this error indicator, the user is advised to switch off the AccuTemp Heater,
and call the Customer Helpline (1800 1033 123)
AccuTemp Heater does not turn on:
In case the Power ON indicator does not turn on even after the AccuTemp Heater is switched on,
then the following scenarios are likely to have happened:
1. The fuse has blown
In the event the fuse has blown, the user should replace the fuse, and try turning the
AccuTemp Heater on again.

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WARNING
Use utmost care while replacing the fuse.
Ensure that the heater power cord is unplugged from the socket. Ensure that your hands are dry,
before removing the fuse-holder cap.
Place the Heater on an insulated surface before unscrewing the fuse cap.
After replacing the fuse, ensure that the fuseholder cap is screwed in completely and tighly.
Only use a 3.15 slow blow fuse as a replacement, DO NOT use a higher or lower rated fuse.

2. The electronic circuit is damaged


Exposure to adverse power conditions may sometimes do more damage than simply blowing the
fuse. These may damage the internal circuitry of the AccuTemp Heater. In the event the
internal circuit is damaged, and the AccuTemp Heater does not turn on even after replacing
the fuse, the AccuTemp Heater will need to be repaired or replaced
In case of such an event occurring, the user is advised to switch off power, unplug the AccuTemp
Heater, and contact our Customer Helpline (1800 1033 123)

4.5 SAFETY INSTRUCTIONS FOR WARMPAK

Ensure that the WarmPak does not have any tears or leaks before using it

Do not bring any sharp-edged objects near the WarmPak

Place the WarmPak with the PCM side on the AccuTemp Heater surface. Align the
WarmPak when placing in the AccuTemp Heater, as shown below

Only use the AccuTemp Heater provided with the unit to heat the WarmPak. Heating it by
other methods is not safe and may result in injury to the newborn

Use the WarmPak only in conjunction with the BabyWrap. Do not use the WarmPak with
any other newborn interface. Embrace Innovations cannot guarantee the performance of the
WarmPak when used with a newborn interface other than the BabyWrap

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Do not place the newborn directly on the WarmPak

Always insert the WarmPak in the WarmPak compartment of the BabyWrap. Make sure
that the WarmPak is correctly oriented when inserting. The water layer of the WarmPak
faces the newborn, as shown below

Before using the WarmPak, check the WarmPak temperature indicator and ensure that it
indicates that the WarmPak is ready to use. Do not use the WarmPak if the temperature
indicator is damaged or torn or peeling off from the WarmPak

Do not expose the WarmPak to Ultraviolet rays or leave it under the sun

Store the WarmPak in a dry place, preferably at room temperature. Do not refrigerate the
WarmPak

Always store the WarmPak flat on a clean flat surface. Do not fold it, or store it in the
AccuTemp Heater

Do not consume the contents of the WarmPak

Use the WarmPak only for the purpose of providing warmth to a newborn in the BabyWrap.
Do not use it in any manner other than as prescribed

Replace the WarmPak immediately if the temperature indicator peels off or is damaged

Refer to 6.2 MAINTENANCE AND STORAGE for directions on when to discard WarmPak.

CAUTION
Do not use the following cleaning solutions for cleaning:

Solutions that contain Methyl Ethyl Ketones, tolulene and/or acetones.

Solutions that have been known to injure infant skin or are toxic to infants

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4.6 SAFETY INSTRUCTIONS FOR BABYWRAP


1. Check the BabyWrap for wear and tear before using it. Do not use the BabyWrap if there is
any damage to the straps, buckles, Velcro, plastic window, or cloth.

2. Place the newborn with the head in the hood and secure the flaps as indicated below.

3. If newborn is smaller than the length of the BabyWrap, use a cushion to prop up the newborn
as shown here.

cushion

4. Ensure that the temperature indicator is visible through the temperature indicator-viewing
window.
5. Do not place more than one newborn in a BabyWrap simultaneously.
6. Use newborn-safe cleaning liquid as described in 6.1 CLEANING to sanitize the BabyWrap. Do
not use harsh cleaning liquids or bleach that may harm the newborns skin.
7. Do not use the BabyWrap if there is bacterial growth, or any visual contamination in it.
8. Always ensure that a fresh, washed and sanitized BabyWrap is used for every new newborn.
There is a risk of cross infection if these washing and sanitizing instructions are not followed.

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CHAPTER 5: OPERATING THE WARMER


This chapter contains step-by-step instructions on operating the Embrace Nest. It is advisable to go
through this chapter in detail and clarify any questions or concerns with an Embrace Innovations
representative before operating the device.
The illustrated instructions-for-use section, at the beginning of this manual, can be used as a quick
reference once the user is more comfortable with the detailed instructions described below.

5.1 CHECKING EQUIPMENT BEFORE USE


Before operating the Embrace Nest check for the following and do not use if there are any signs of
damage as described below:
1. BabyWrap - Examine the lining material for signs of deterioration and any wear and tear of the
BabyWrap. Ensure that the BabyWrap has been washed and disinfected before use
(especially the inner areas of the newborn compartment).
2. WarmPak - Examine for any wear and tear or leakage. Also ensure that the WarmPak
temperature indicator is firmly attached to the WarmPak and is not peeling off.
3. AccuTemp Heater- Plug in the device and switch on the main power supply. Check that the
Power ON indicator illuminates. This ensures that the AccuTemp Heater is receiving power
and functioning properly. In case of an error indicator (see 4.4 ERROR INDICATORS FOR THE
ACCUTEMP HEATER), turn the AccuTemp Heater off and contact the Customer Helpline
1800 1033 123.
Refer to 6.2 MAINTENANCE & STORAGE for directions on when to discard WarmPak.

CAUTION
Do not use the following cleaning solutions for cleaning:
- Solutions that contain Methyl Ethyl Ketones, tolulene and/or acetones.
- Solutions that have been known to injure infant skin or are toxic to infants

5.2 GETTING READY


Before using the Embrace Nest complete the following steps:
1. Ensure that all the components of the Embrace Nest are in good condition as mentioned in the
section above.
2. Sanitize the WarmPak and the BabyWrap using one of the recommended cleaning liquids 6.
For detailed instructions refer to 6.1 CLEANING.
3. Ensure that the AccuTemp Heater WarmPak tray is clean.
The metal sensor on the inside of the AccuTemp Heater lid must be cleaned before use. It is what
detects the WarmPak temperature and ensures it is heated to the correct temperature.

Refer to Glossary of terms for a list of recommended cleaning liquids

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5.3 USING THE EMBRACE NEST


Prepare the unit as described above.

Setting up the AccuTemp Heater


1. Place the AccuTemp Heater on a flat surface.
2. Plug in the AccuTemp Heater to the main power supply (wall socket) and ensure that the
POWER ON indicator is illuminated (blue).
3. Ensure that there are no error indicators as indicated in 4.4 ERROR INDICATORS FOR THE
ACCUTEMP HEATER
4. To open the lid push the sliding latch sideways and lift the lid.
5. Place the WarmPak into the AccuTemp Heater WarmPak Tray with the PCM layer touching
the heating surface. To assist proper positioning of the WarmPak note the two indicators:

The Embrace Innovations logo should be upright, and the word Embrace should be
readable.

The notch on the top right corner of the WarmPak aligns with the notch on the
WarmPak cavity tray on the AccuTemp Heater, very much like a cell phone SIM-card.

6. Close the lid. Ensure that the latch clicks back to position. If the WarmPak is slightly crumpled
after use, you may have to use both hands to push down on the lid when closing the
AccuTemp Heater.

Starting the heating cycle


7. Press the Start/Stop button on the AccuTemp Heater to begin the heating process. The
HEATING CYCLE ON indicator glows (amber) to indicate that the heating cycle is in progress.

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8. If for some reason the heating cycle needs to be paused, press the Start/Stop button to pause
the heating cycle. This will turn off the HEATING CYCLE ON indicator. Press the Start/ Stop
button again when you wish to restart the heating cycle.

NOTE
The Start/Stop button will only work when the AccuTemp Heater lid is closed and latched in place.
Press the Start/Stop button and ensure that your action has registered correctly by checking to see if
the HEATING CYCLE ON indicator has turned on/off.

9. After approximately 35 minutes, the buzzer will beep once to indicate that the heating cycle is
complete, and will beep once again a minute after that. The WARMPAK READY indicator will
turn on and stay illuminated (green) indicating the WarmPak is ready for use.

NOTE
Some un-melted wax may remain in the WarmPak even after the AccuTemp Heater indicates the
heating is complete. This is completely normal, and should not be treated as an error.
The WarmPak may be slightly distorted or crumpled after use. This is perfectly normal, and the
WarmPak may be reused as usual.

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CAUTION
It is not advisable to open the AccuTemp Heater lid during the heating cycle, as the heating surface
gets very hot while heating up the WarmPak.
If the user opens the lid without pressing the Start/Stop button, then the AccuTemp Heater will
automatically turn off the heating cycle, and give off a continuous high pitched warning beep. This is
to warn the user that the heating surface may be very hot to touch, and can cause burns, should the
user accidentally touch the heating surface in the process of retrieving the WarmPak. The alarm
will sound even if the user presses the Start/Stop button before opening the lid, as the heating plate
will still be hot and pose a burn risk to the user.

Removing the heated WarmPak from the AccuTemp Heater


10. The WARMPAK READY indicator will remain illuminated (green) until the lid is lifted or the
Start/Stop button is pressed. This indicates that the AccuTemp Heater is maintaining the
WarmPak at the operating temperature.
11. Open the lid and remove the heated WarmPak when ready to use.

Ever-ready mode: Keeping the WarmPak warm in the AccuTemp Heater


After approximately 35 minutes, when the heating cycle is complete, the WarmPak will be at the
operating temperature and ready to use. However, as long as the user does not press the Start/Stop
button or lift the lid the AccuTemp Heater will continue to maintain the WarmPak at the
operating temperature, until the user needs to use the WarmPak.

This allows the user to place a WarmPak in the AccuTemp Heater and heat it up well in
advance rather than planning to heat it right before the WarmPak is needed.
It is recommended to leave the WarmPak in the AccuTemp Heater until it needs to be used as
the ever-ready mode has very low power consumption.

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CAUTION
Do not open lid until heating cycle is complete.
Every time the user opens the lid, the heating cycle will get turned off. Therefore, in the event the
user opens the lid but changes their mind and decides to let the WarmPak stay in the AccuTemp
Heater, it is imperative that they close the lid, and then press the Start/Stop button to ensure that
the heating cycle is turned back on again.
This will enable the AccuTemp Heater to maintain the WarmPak at the operating temperature,
until the user needs to retrieve the WarmPak.

Setting up the WarmPak in the BabyWrap


1. Remove the heated WarmPak from the AccuTemp Heater. Check the WarmPak
temperature indicator. The indicator bar should be in the OK region.
2. If the instructions for heating have not been followed correctly, the WarmPak may be
overheated beyond the safe operating temperature. If the indicator bar is in the TOO HOT
state, DO NOT use the WarmPak.
3. Insert the heated WarmPak in the WarmPak compartment of the BabyWrap. Ensure that it
lies flat inside the WarmPak compartment.

NOTE
Ensure the WarmPak is in the proper orientation to ensure the water layer is facing up.

4. Once the WarmPak is inserted, ensure that the temperature indicator is visible through the
transparent viewing window at the bottom right corner of the BabyWrap.

CAUTION
Do not place the newborn directly on the WarmPak. The heated WarmPak should not be used in
any other manner except with the Embrace BabyWrap.
Remember to monitor the temperature of the WarmPak by periodically (every 30 minutes)
checking the WarmPak temperature indicator, to ensure that it is within the operating range. As
the indicator bar drops below the OK state, the user must keep in mind that the WarmPak is
running out of charge.
As soon as the indicator bar drops into the TOO COLD state, it is time to remove the WarmPak,
and replace with a reheated WarmPak.

Preparation of the newborn


1. Ensure that the newborn has been fed, and is clinically stable.
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2. Ensure that the newborn has a fresh diaper on.


3. Wrap the newborn in a light cotton cloth as shown below. In case of a newborn with an IV line
attached, thread the IV line through the cotton wrap as shown below.

CAUTION
Do not bundle up the newborn with several layers of the cotton wrap. Ensure that there is only a
thin layer of cloth between the newborn and the BabyWrap cloth in contact with the newborns
back. This will ensure adequate thermal contact between the newborn and the WarmPak.
If the caregiver feels that additional insulation is needed, additional blankets can be placed over the
ventral surface (chest and stomach) of the newborn.

Setting up the BabyWrap


1. After placing the heated WarmPak in the WarmPak compartment, place the BabyWrap on a
flat surface with the newborn compartment facing up.
2. Place the newborn with its head in the hood of the BabyWrap.
3. Wrap the left flap on the newborn (as shown below) and then bring the right flap over it.
4. Pass the strap through the buckle and secure it on the Velcro strap. Repeat the process for all
the three straps. Tuck the tail flap towards the back. Ensure a snug yet comfortable fit for the
newborn by appropriately tightening or loosening the flaps and straps.
5. In case the newborn is smaller than the BabyWrap size, use the cushion provided to shore up
the legs of the newborn, to prevent it from slipping down when inside the BabyWrap.

WARNING
Ensure that straps are not so tight that they hamper the natural breathing mechanics of the
newborn.

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Monitoring the newborn inside the BabyWrap


Monitor the breathing and skin color of the newborn through the observation window on the
BabyWrap.
To check the temperature using a thermometer, loosen the BabyWrap as necessary to collect the
axillary temperature.
To check the temperature of the newborn by hand, loosen or remove the tail flap and feel the
newborns feet.

NOTE
The BabyWrap (and WarmPak) will maintain the operating temperature for at least 4 hrs in
normal operating conditions 7. In colder environments the WarmPak may not last as long and may
need to be replaced with a freshly heated WarmPak sooner than the 4 hour recommendation.
It is therefore imperative to keep monitoring the WarmPak temperature indicator (every 30
minutes) to ensure that the WarmPak is within the operating temperature range.
It is also imperative to periodically monitor the newborns vitals while in the BabyWrap to ensure
that it is healthy, and to pre-empt sudden changes in the vitals.
See Table 1 in TECHNICAL SPECIFICATIONS for details on WarmPak performance at different
ambient temperatures.

Refer Glossary for definition of normal operating conditions

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CHAPTER 6: CLEANING, MAINTENANCE AND STORAGE


6.1 CLEANING
It is recommended to use one of the following to periodically sanitize the various components of the
Embrace Nest:
Commercially available brands such as Lysol, Dettol or any newborn-friendly cleaning solutions that
you normally use for cleaning plastics and other surface that the newborn comes in contact with.

AccuTemp Heater

Sanitize AccuTemp Heater frequently:


All exposed surfaces of the AccuTemp Heater may be cleaned with a dry cotton swab/ cloth.

CAUTION
Do not use cloth saturated in excess liquid or immerse the AccuTemp Heater in water.

WarmPak

Sanitize WarmPak thoroughly before use:


The WarmPak may be sanitized as shown above with a damped cotton swab/ cloth dipped in one
of the above-mentioned cleaning solutions.

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CAUTION
Do not use cloth saturated in excess liquid or immerse the WarmPak in water.
Pay careful attention that the temperature indicator is not damaged or does not peel off in the
process of cleaning the WarmPak.

BabyWrap
Soak in solution

Scrub/Rinse

Wash BabyWrap thoroughly in-between use across different newborns:

Before use across different newborns, the BabyWrap must be washed using a solution of
water and one of the above-mentioned cleaning agents, for each new use.

Before placing a newborn in the BabyWrap, sanitize the BabyWrap with a damp cotton
swab/ cloth dipped in one of the above-mentioned cleaning solutions.
Sanitize inner lining

Sanitize BabyWrap thoroughly for prolonged use with the same newborn:

For use with the same newborn, periodically sanitize the BabyWrap with a damp cotton
swab/ cloth dipped in one of the above-mentioned cleaning solutions.

Pay careful attention to areas with seams, and to creases which tend to accumulate dirt.

It is recommended that the BabyWrap be replaced every 24 hours with a fresh, washed
and sanitized unit in order to avoid build-up of contamination in the BabyWrap.

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NOTE
The user of the Embrace Nest equipment must not use any methods for cleaning and
decontamination other than those recommended by Embrace Innovations without first checking
with Embrace Innovations that these methods do not harm the device. It is important to regularly
clean and disinfect the device to ensure safety and efficacy.
CAUTION
Do not use the following cleaning solutions for cleaning:
Solutions that contain Methyl Ethyl Ketones, tolulene and/or acetones.
Solutions that have been known to injure infant skin or are toxic to infants

6.2 MAINTENANCE & STORAGE


AccuTemp Heater

Keep the AccuTemp Heater in a cool, dry place

Do not expose it to extreme temperature conditions outside of the recommended storage


and operating range

Do not handle roughly or drop the unit

Do not place heavy objects on the AccuTemp Heater

Avoid subjecting the AccuTemp Heater to extreme vibrations during transport

Do not attempt to repair or modify the AccuTemp Heater

WarmPak

The WarmPak must be stored as a separate unit in the WarmPak bag provided

When not in use, ensure that the WarmPak is wrapped in plastic, and kept away from
insects, rodents etc.

Ensure that the WarmPak is stored in a dry place, preferably at room temperature. Do not
refrigerate the WarmPak. Keep away form sunlight.

Do not fold the WarmPak. Always store in a flat position.

If the water layer shows any signs of bacterial growth within it, please discard the
WarmPak

BabyWrap

Ensure that the BabyWrap is completely dry (no damp spots) before storing it

When not in use, keep the BabyWrap wrapped in plastic, and store in a cool, dry place

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Periodically check the BabyWrap to ensure that it is free of dust, insects etc.

6.3 PERIODIC CALIBRATION CHECK


Once every three months, verify the temperature of a heated WarmPak with a standard
clinical thermometer to ensure that it is within the recommended operating range.
If the temperature of the heated WarmPak is not within the recommended operating range,
i.e. if the AccuTemp Heater is over- or under- heating the WarmPak, do not use the
AccuTemp Heater.
Contact us using the information in the section on CUSTOMER SERVICE INFORMATION to report
the problem.

6.4 PERIODIC REPLACEMENT OF THE WARMPAK


Please replace the WarmPak after 6 months from the date of first use. DO NOT use the
WarmPak after its expiry date, under any circumstances.

NOTE
The WarmPak may turn slightly yellow over time. This is normal and will not affect product
functionality in any way.

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TECHNICAL SPECIFICATIONS
ACCUTEMP HEATER
Operating Voltage: 230 V AC, 50 Hz
Fuse Rating: 3.15 A Time-lag/ Slow Blow fuse
Power Consumption: 500 Watt (peak power consumption at 230 V, approx. 15 Watt power
consumption in dwell mode)
Dimensions: 440 mm x 290 mm x 70 mm
Weight: 2.5 Kg
Heat-up time:
May vary depending on ambient temperature, and supply voltage. On an average, the heat up time
is approximately 35 minutes under 230 V AC input and 25 C ambient operating temperature.
Table 1: Performance at varying ambient temperatures
Time taken to heat WarmPak to
ready state in AccuTemp Heater

WarmPak duration in OK range

10 C

approximately 35 minutes

~1.5 hours

25 C

approximately 35 minutes

at least 4 hours

34 C

approximately 25 minutes

over 10 hours

Low Voltages may take longer.


Heating Element:
Heating element has been designed to withstand up to 1.5 kV breakdown voltage.
Aluminum plate has been grounded, and connected to the ground pin of the power cord
Operating Conditions:
Temperature: 10 to 34C
Humidity: 30 to 75%
Shipping and Storage Conditions:
Temperature: -20 to 40C
Humidity: 10 to 90% (non condensing)

WARMPAK
Dimensions: 380 mm x 220 mm
Weight: 1.3 kg
Operating Conditions:
Temperature: 10 to 34C
Humidity: 30 to 75%
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Shipping and Storage Conditions:


Temperature: -20 to 40C
Humidity: 10 to 90% (non condensing)
Chemical contents:
The WarmPak contains two compartments, one containing a non-toxic phase change material
(PCM), and the other containing potable drinking water. (Please refer to the section on MATERIAL
SAFETY at the end of this chapter for material safety information.

WARMPAK TEMPERATURE INDICATOR


Dimensions: 40 mm x 60 mm
Weight: 2 gm
Operating Conditions:
Temperature: 10 to 34C
Humidity: 30 to 75%
Shipping and Storage Conditions:
Temperature: -20 to 40C
Humidity: 10 to 90% (non condensing)

BABYWRAP
Dimensions: 520 mm x 250 mm
Weight: 0.31 kg
Operating Conditions:
Temperature: 10 to 34C
Humidity: 30 to 75%
Shipping and Storage Conditions:
Temperature: -20 to 40C
Humidity: 10 to 90% (non-condensing)

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MATERIAL SAFETY SPECIFCATIONS


PCM
HAZARDS IDENTIFICATION
EUROPEAN HAZARD CLASSIFICATION
This product is not classified as dangerous according to Directive 67/548/EEC
NORTH AMERICA
Non-Hazardous

EMERGENCY OVERVIEW
Potential Health Effects
Eye - Accidental exposure to the eyes may produce a mild but transient irritation
Skin Very mild to no irritation expected.
Inhalation - No harmful effects expected with normal use
Ingestion - May cause gastrointestinal irritation
If product is heated, vaporization can occur. Eye, skin, and upper respiratory irritation
can occur
PHYSICAL/CHEMICAL HAZARDS:
None identified
ENVIRONMENTAL HAZARDS
None identified

FIRST AID MEASURES


Eye - In case of contact, immediately flush eyes with plenty of water for at least 15 minutes.
Get medical attention.
Skin - Wash skin with soap and water upon contact. Remove contaminated clothing. If irritation
persists, get medical attention. Wash clothing before reuse.
Inhalation - Remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult,
give oxygen. Get medical attention immediately.
Ingestion - If swallowed, do NOT induce vomiting. Get medical attention. Never give anything by
mouth to an unconscious person.

TOXICOLOGICAL INFORMATION
ACUTE ORAL TOXICITY (TESTED ON RATS)
Practically non-toxic. The acute oral LD50 was greater than 20 ml/kg body weight.
EYE IRRITATION (TESTED ON RABBITS)
The application of undiluted material to the rabbits eye produced only mild transient irritation.
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SKIN IRRITATION (TESTED ON HUMANS)


A 24 hour human patch test indicated that undiluted PCM produced very mild irritation. The
irritation was less than the result produced by a 4% aqueous soap solution.

BABYWRAP INNER LINING MATERIAL


BACTERIAL RESISTANCE OK as per AATCC 6538/9642
SKIN IRRITATION ISO 10993-10: Certified Safe (NEGATIVE)
CYTOTOXICITY ISO 10993-5: Certified Safe (NEGATIVE)
SKIN SENSITIZATION ISO 10993-10: Certified Safe (NEGATIVE)
Inner lining material used as a covering for hospital beds and surgical tables.

WATER LAYER
Water layer is comprised of potable water.
NOTE: Specifications are subject to change at any time

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LIMITED WARRANTY
Embrace Technologies, Inc. (the Manufacturer) warrants to the Original Purchaser of the
Embrace Nest infant warmer the following:
AccuTemp Heater: The AccuTemp Heater shall be free from defects in materials and
workmanship under normal use, if used in accordance with this Operation Manual, for a period of
one year from the date of sale to the Original Purchaser. THERE ARE NO OTHER WARRANTIES.
WarmPak: The WarmPak shall be free from defects in materials and workmanship under normal
use, if used in accordance with this Operation Manual, for a period of six months from the date of
sale to the Original Purchaser. THERE ARE NO OTHER WARRANTIES.
BabyWrap: The BabyWrap shall be free from defects in materials and workmanship under
normal use, if used in accordance with this Operation Manual, for a period of six months from the
date of sale to the Original Purchaser. THERE ARE NO OTHER WARRANTIES.
THIS WARRANTY ON THE ABOVE THREE COMPONENTS DOES NOT COVER NORMAL WEAR AND TEAR
AND MAINTENANCE ITEMS, AND EXCLUDES ACCESSORY OR EQUIPMENT USED ALONG WITH THE
EMBRACE NEST INFANT WARMER.
Subject to the conditions of, and upon compliance with this Limited Warranty, the Manufacturer will
repair or replace at its option without charge (except for postage/ courier & handling) any
Embrace Nest infant warmer (not including accessories) which is defective if a claim is made during
above mentioned period.
The following conditions, procedures & limitations apply to the Manufacturers obligation under this
warranty:
A. Parties covered by this warranty: This warranty extends only to the Original Purchaser of
the Embrace Nest infant warmer. This warranty does not extend to any subsequent
purchasers. The Original Purchaser may be medical personnel, a hospital, clinic or other
medical institution which purchases the Embrace Nest infant warmer for treatment of
patients. The Original Purchaser should retain the invoice or sales receipt as proof of the
actual date of purchase.
B. Warranty Performance Procedure: Notice of the claimed defect must be made to the
Manufacturer by calling the Manufacturer Customer Helpline toll free number 1800 1033
123 or by writing to the Manufacturer at the following address: Embrace Customer Service,
#18/19, Platinum Square, 2nd Floor, Leonard Lane, Richmond Town, Near Johnson Market,
Bangalore 560025 Notice to the Manufacturer must include the date of purchase, serial
number and a description of the claimed defect in sufficient detail to allow the manufacturer
to determine and facilitate any repairs which may be necessary. The warranty claim will be
registered by the Customer Service Department and a warranty claim reference number will
be given to the customer for future reference and use. Authorization must be obtained prior
to returning part or whole of the Embrace Nest infant warmer.

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C. Conditions of Warranty: The Warranty is void if any of the components have been 1)
repaired by someone other than the Manufacturer or its authorised agent; 2)altered so that
its stability or reliability is affected; 3) misused; or 4)damaged by negligence or accident.
Misuse includes, but is not limited to, use not in compliance with this Operation Manual or
use with non-approved accessories. Removal or damage to any of the components serial
number will invalidate this warranty.
D. Limitations and Exclusions: Repair or replacement of the Embrace Nest infant warmer
or any component thereof is the EXCLUSIVE remedy offered by the Manufacturer. The
following exclusions and Limitations shall apply:
1. No agent, representative or employee of the Manufacturer has authority to bind the
Manufacturer to any representation or warranty expressed or implied.
2. The Embrace Nest infant warmer can only be used in a clinic, hospital, nursing home or
other medical institution under the supervision of the medical personnel who have been
trained on using the product and whose skill and judgement determine the suitability of the
product for use in caring for hypothermic newborns.
3. All recommendations, information and descriptive literature supplied by the
Manufacturer or its agents are believed to be accurate and reliable, but do not constitute
warranties.
4. Warranty claims are not valid against intentional damage or damage by use of force,
damage by pests, accident or the components not being used as prescribed in the Operation
Manual.
5. Warranty claims are not valid against acts of nature like fire, floods etc.
The Manufacturer disclaims responsibility for the suitability of the Embrace Nest for any
particular medical treatment not indicated in this Operation Manual, or for any medical
complications resulting from the use of the Embrace Nest. The Manufacturer shall not be
responsible for any incidental damages or consequential damages to property, loss of
profits, or loss of use caused by any defect or malfunction of the Embrace Nest.

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GLOSSARY OF TERMS
H
Hypothermia
A term used to refer to subnormal temperature of the body i.e. temperature less than 36.5 C. It is a
condition widely prevalent in newborns that do not have enough subcutaneous fat to sustain body
temperature during the first few days after birth.
The newborn loses its thermal balance due to factors such as evaporation of amniotic fluid,
convection of air current or conduction through contact with cold objects. Such babies need to be
provided external source of warmth until the body temperature stabilizes.
Hypothermic
A condition denoting a patient suffering from hypothermia

N
Normothermia
The human body functions at its optimum when the core body temperature is between 36.5 C and
37.5 C. This core-body temperature condition is referred to as Normothermia.
Normal Operating Conditions
With reference to the Embrace Nest the normal operating conditions are defined as shown below:

The input voltage supplied to the AccuTemp Heater for heating up the WarmPak will be
230V AC, 50 Hz. Further, the AccuTemp Heater is operated at an ambient temperature of
25 C.
The BabyWrap, heated WarmPak and newborn are at an ambient temperature of 25 C.

Under these normal operating conditions, the expected performance of the Embrace Nest is as
below:

The AccuTemp Heater has been designed to heat the WarmPak up to a temperature
between 37 C and 40 C in approximately 35 minutes.
The heated WarmPak, when placed in the BabyWrap, along with the newborn, will stay
at the operating temperature (defined below) for at least 4 hours.

Embrace Nest Operation Manual (0602-50001-002)

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O
Operating Temperature
The operating temperature with reference to the Embrace Nest is when the temperature of the
WarmPak, when placed inside the BabyWrap, is approximately 37 C. 8 When the WarmPak is at
this temperature, it is safe to keep the newborn inside the BabyWrap. The WarmPak should not
be used if the WarmPak temperature indicator indicates that the WarmPak is outside the
operating temperature range.

P
Phase Change Material (PCM): A phase change material is a substance that melts and solidifies at a
certain temperature. Heat is absorbed or released when the material changes from solid to liquid
and vice versa.

WHO reference number: WS 420 97TH Thermal protection of the newborn: a practical guide

Embrace Nest Operation Manual (0602-50001-002)

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Embrace Nest Operation Manual (0602-50001-002)

Page 45

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