Embrace Opertations Manual

OPERATIONMANUAL

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.

Embrace™ Nest Operation Manual (0602-50001-002) Page 2

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


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


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: [email protected] or [email protected] 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.


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.


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 1.5-2.5 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. The Embrace™ Nest consists of three components:

BabyWrap™ An interface in which the newborn rests

WarmPak™ A removable pack of phase-change material (PCM) and water which, when heated, serves as the source of warmth

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


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 ~37⁰C for at least 4 hours1 without the need to be reheated. This is the same temperature range as recommended by the World Health Organization (WHO) for a heated water mattress2

.

1 duration of at least 4 hours when ambient temperature is 25 ⁰C or higher 2 WHO reference number: WS 420 97TH “Thermal protection of the newborn: a practical guide”

Temperature stays at ~37⁰C for at least 4 hours (when ambient temperature is 25⁰C or higher)

WarmPak™ Temperature Performance

The Key Features of Embrace™ Nest are:

• Maintains a temperature of ~37⁰C 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


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 newborns3

• In rooms where the ambient temperature is low

in a clinical setting:

• 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 ⁰C, 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 doctor’s discretion.

3 clinically stable newborns weighing between 1.5 to 2.5 kilograms


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 1

WarmPak™ 1

BabyWrap™ + cushion 1 + 1

Instructional Poster 1

Operation Manual 1

WarmPak Bag 1

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.


3.2 ACCUTEMP™ HEATER

The AccuTemp™ Heater warms the WarmPak™ to the operating temperature4

. 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 ⁰C and 40 ⁰C) and is not, under any circumstances, overheated (greater than 41 ⁰C).

Under normal operating conditions5

• Automatically resumes heating in case of power outage

it takes approximately 35 minutes for the AccuTemp™ Heater to heat the WarmPak™ to the operating temperature.

• 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 See Glossary for definition of operating temperature 5 See Glossary for definition of normal operating conditions


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.

“POWER ON” Indicator - This indicator glows blue to indicate unit is receiving AC mains supply.

“HEATING CYCLE ON” Indicator - This indicator glows amber to indicate heating cycle is in progress.


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.

“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.


• 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™.


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™.

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.


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:


“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.


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.


BabyWrap™ user interface

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.

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 newborn’s 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™ Compartment-An insulated compartment to place the heated WarmPak™. The compartment can be opened and closed with a zip.


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.


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.


• 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:

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 works correctly:

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.

AccuTemp™ Heater displays a malfunction error:

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)

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:

AccuTemp™ Heater does not turn on:

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.


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™


• 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


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.

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 newborn’s 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.

cushion


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


- 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 liquids6

6.1 CLEANING.

For detailed instructions refer to .

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.

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


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.


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.


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.


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.


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 newborn’s 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.


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 newborn’s feet.

NOTE

The BabyWrap™ (and WarmPak™) will maintain the operating temperature for at least 4 hrs in normal operating conditions7

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.

. 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 also imperative to periodically monitor the newborn’s 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.

7 Refer Glossary for definition of normal operating conditions


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.


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™

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 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™.

Soak in solution Scrub/Rinse

Sanitize inner lining


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


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


• 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.


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 34°C Humidity: 30 to 75% Shipping and Storage Conditions: Temperature: -20 to 40°C Humidity: 10 to 90% (non condensing) WARMPAK™ Dimensions: 380 mm x 220 mm Weight: 1.3 kg Operating Conditions: Temperature: 10 to 34°C Humidity: 30 to 75%


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


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 rabbit’s eye produced only mild transient irritation.


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


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 Manufacturer’s 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.


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.


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.


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

P

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.

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.

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

Embrace Opertations Manual

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