Documente Academic
Documente Profesional
Documente Cultură
MANUAL
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
Embrace Nest Operation Manual (0602-50001-002)
Page 2
Page 3
Page 4
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.
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.
Page 5
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.
Page 6
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
WarmPak
AccuTemp Heater
A precision conduction
heater that heats the
WarmPak to the
operating temperature
before every use
Page 7
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.
Page 8
To provide warmth to clinically stable pre-term and low birth weight newborns 3 in a clinical setting:
On examination tables
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.
Page 9
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.
Page 10
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
Page 11
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.
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.
Page 12
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.
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.
Page 13
The water layer eliminates the presence of hotspots, and thus provides a surface of uniform
heat to the newborn.
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:
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.
Page 14
The WarmPak
Temperature Indicator
indicates to the user if
the WarmPak can be
used or if it needs to
be reheated.
Page 15
Page 16
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.
Page 17
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.
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 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.
Page 18
Page 19
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.
Page 20
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.
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.
Page 21
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.
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.
Page 22
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.
Ensure that the WarmPak does not have any tears or leaks before using it
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
Page 23
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
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 have been known to injure infant skin or are toxic to infants
Page 24
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.
Page 25
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
Page 26
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.
Page 27
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.
Page 28
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.
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.
Page 29
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.
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.
Page 30
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.
WARNING
Ensure that straps are not so tight that they hamper the natural breathing mechanics of the
newborn.
Page 31
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.
Page 32
AccuTemp Heater
CAUTION
Do not use cloth saturated in excess liquid or immerse the AccuTemp Heater in water.
WarmPak
Page 33
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
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.
Page 34
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
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.
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
Page 35
Periodically check the BabyWrap to ensure that it is free of dust, insects etc.
NOTE
The WarmPak may turn slightly yellow over time. This is normal and will not affect product
functionality in any way.
Page 36
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
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
WARMPAK
Dimensions: 380 mm x 220 mm
Weight: 1.3 kg
Operating Conditions:
Temperature: 10 to 34C
Humidity: 30 to 75%
Embrace Nest Operation Manual (0602-50001-002)
Page 37
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)
Page 38
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
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.
Embrace Nest Operation Manual (0602-50001-002)
Page 39
WATER LAYER
Water layer is comprised of potable water.
NOTE: Specifications are subject to change at any time
Page 40
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.
Page 41
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.
Page 42
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.
Page 43
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
Page 44
Page 45