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Summary of Contents for embrace nest
- Page 1 OPERATION MANUAL AN AWARD WINNING, AFFORDABLE INFANT WARMER...
- Page 2 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.
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Page 3: Table Of Contents
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™... - Page 4 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 Embrace™ Nest Operation Manual (0602-50001-002) Page 3...
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Page 5: About The Company
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. -
Page 6: About This Manual
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. -
Page 7: Customer Service Information
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 8: Chapter 1: Introduction
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. - Page 9 Temperature stays at ~37⁰C for at least 4 hours (when ambient temperature is 25⁰C or higher) The Key Features of Embrace™ Nest are: • Maintains a temperature of ~37⁰C for at least 4 hours • Does not require a constant supply of electricity •...
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Page 10: Chapter 2: Uses And Application
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. -
Page 11: Chapter 3: Product Description
CHAPTER 3: PRODUCT DESCRIPTION The Embrace™ Nest starter pack consists of the components listed below. Check the contents upon unpacking and verify that all components are available. Check for any damage that may have occurred during shipping. Product Quantity AccuTemp™ Heater WarmPak™... -
Page 12: Accutemp™ Heater
WarmPak™ to the operating temperature 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. -
Page 13: Accutemp™ Heater User Interface
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™. -
Page 14: Warmpak
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. Embrace™ Nest Operation Manual (0602-50001-002) Page 13... - Page 15 Lower ambient temperatures may cause faster heat loss from the WarmPak™, thereby reducing the usable duration. Embrace Innovations recommends that the user must bear in mind all these factors when using the WarmPak™ and periodically check the temperature indicator of the WarmPak™ and closely monitor the vital signs of the newborn placed in the BabyWrap™.
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Page 16: Warmpak™ User Interface
The SIM-card shape also serves AccuTemp™ Heater, or into the BabyWrap™, ensure that the to help the user in correctly water layer is facing up. orienting the WarmPak™ when placing it into the BabyWrap™. Embrace™ Nest Operation Manual (0602-50001-002) Page 15... -
Page 17: Warmpak™ Temperature Indicator
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: Embrace™ Nest Operation Manual (0602-50001-002) Page 16... - Page 18 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. Embrace™ Nest Operation Manual (0602-50001-002) Page 17...
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Page 19: 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 Embrace™ Nest Operation Manual (0602-50001-002) -
Page 20: Babywrap™ User Interface
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. Embrace™ Nest Operation Manual (0602-50001-002) Page 19... - Page 21 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. Embrace™ Nest Operation Manual (0602-50001-002) Page 20...
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Page 22: Chapter 4: Safety Instructions And Error Indicators
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. -
Page 23: Error Indicators For The Accutemp™ Heater
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. Embrace™ Nest Operation Manual (0602-50001-002) Page 22... -
Page 24: Safety Instructions For Warmpak
• 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™ Embrace™ Nest Operation Manual (0602-50001-002) - Page 25 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 Embrace™ Nest Operation Manual (0602-50001-002) Page 24...
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Page 26: Safety Instructions For Babywrap
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. Embrace™ Nest Operation Manual (0602-50001-002) Page 25... -
Page 27: Chapter 5: Operating The Warmer
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. -
Page 28: Using The Embrace™ Nest
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. •... - Page 29 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. Embrace™ Nest Operation Manual (0602-50001-002) Page 28...
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Page 30: Removing The Heated Warmpak™ From The Accutemp™ Heater
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. Embrace™ Nest Operation Manual (0602-50001-002) Page 29... -
Page 31: Setting Up The Warmpak™ In 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”... -
Page 32: Setting Up The Babywrap
BabyWrap™. WARNING Ensure that straps are not so tight that they hamper the natural breathing mechanics of the newborn. Embrace™ Nest Operation Manual (0602-50001-002) Page 31... -
Page 33: Monitoring The Newborn Inside The Babywrap
See Table 1 in TECHNICAL SPECIFICATIONS for details on WarmPak™ performance at different ambient temperatures. Refer Glossary for definition of normal operating conditions Embrace™ Nest Operation Manual (0602-50001-002) Page 32... -
Page 34: Chapter 6: Cleaning, Maintenance And Storage
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. Page 33 Embrace™ Nest Operation Manual (0602-50001-002) -
Page 35: Babywrap
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™. Embrace™ Nest Operation Manual (0602-50001-002) Page 34... -
Page 36: Maintenance & Storage
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. -
Page 37: Periodic Calibration Check
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. Embrace™ Nest Operation Manual (0602-50001-002) Page 36... -
Page 38: Technical Specifications
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% Embrace™ Nest Operation Manual (0602-50001-002) Page 37... -
Page 39: Warmpak™ Temperature Indicator
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) Embrace™ Nest Operation Manual (0602-50001-002) Page 38... -
Page 40: Material Safety Specifcations
ACUTE ORAL TOXICITY (TESTED ON RATS) EYE IRRITATION (TESTED ON RABBITS) Practically non-toxic. The acute oral LD50 was greater than 20 ml/kg body weight. The application of undiluted material to the rabbit’s eye produced only mild transient irritation. Embrace™ Nest Operation Manual (0602-50001-002) Page 39... -
Page 41: Babywrap™ Inner Lining Material
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 Embrace™ Nest Operation Manual (0602-50001-002) Page 40... -
Page 42: Limited Warranty
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. - Page 43 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.
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Page 44: Glossary Of Terms
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. - Page 45 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. 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™...
- Page 46 Embrace™ Nest Operation Manual (0602-50001-002) Page 45...
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