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Copyright © 

November 

202

1

Little Sparrows Technologies

288 Walnut St

,

 Suite 300

Newton

ville, MA 02

460

bili-hut™

 is a trademark of Little Sparrows Technologies.

Date of Issue:
Doc# BH-IFU-002

Rev D DRAFT, 2020-04-XX

CAUTION U.S. federal law restricts this device to sale 

by or on the order of a physician or properly 

licensed practitioner. 

Содержание Bili-hut Home

Страница 1: ...bili hut Home Use Guide Little Sparrows Big ideas for little babies Technolog es ...

Страница 2: ... St Suite 300 Newtonville MA 02460 bili hut is a trademark of Little Sparrows Technologies Date of Issue Doc BH IFU 002 Rev D DRAFT 2020 04 XX CAUTION U S federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner ...

Страница 3: ...to be defective DO NOT make changes to the bili hut DO NOT alter the bili hut Changes to the bili hut should only be made by a Little Sparrows Technologies representative Damage to this device due to improper use is solely the responsibility of the user Little Sparrows Technologies is not responsible for damage from the user making repairs or taking any action not stated in this guide bili hut lab...

Страница 4: ...6 2 5GeneralCautions 17 2 5 1 Electrical Cautions 17 2 5 2 Cautions About Your Baby 17 2 5 3 User Cautions 17 3 Using the bili hut 18 3 1 Assembling and Setting up the bili hut 18 3 2 Operating the bili hut 22 3 3 Removing Your Baby from the bili hut 26 3 4 Actions for an Environment High Temperature Warning 28 3 5 Disassembly 30 4 Maintenance 32 4 1 Cleaning 32 4 1 1 Cleaning the shell 34 4 1 2 C...

Страница 5: ...arnings describe serious adverse reactions and potential safety hazards limitations in use imposed by them and steps that should be taken if they occur Single use Consult instructions for use Eye protection IEC Type BF applied part IEC Class II equipment Direct current CAUTION Federal law restricts this device to sale by or on the order of a physician Temperature limit Manufacturer ...

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Страница 7: ... baby s jaundice The bili hut should only be used by individuals who have read and thoroughly understand this guide 1 2 1 Purpose of this Guide 1 2 2 What is Jaundice Jaundice is a condition that causes yellow discoloration of the skin eyes and mucus membranes It is caused by increased blood levels of bilirubin Jaundice is treated with phototherapy Bilirubin is a yellow pigment that occurs natural...

Страница 8: ... 2 4 What is Phototherapy 1 2 5 What is the bili hut The bili hut is a portable device that uses a curved blue LED light array It is specially designed to deliver high intensity phototherapy treatment to more quickly decrease the amount of bilirubin in a baby s body The bili hut is easy to use clean and transport The bili hut allows for safe and effective treatment in either the clinical environme...

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Страница 10: ...attress shell power supply NOTE Only use the components provided by Little Sparrows Technologies shown in this section with the bili hut The diagrams on this page and the next page show the location of all bili hut components shell power supply base mattress base ...

Страница 11: ...5 Section 1 Overview nest components nest nest mattress nest mattress nest ...

Страница 12: ...iption 1 Magnetic clasps on the base attach to the shell clasps for assembly 2 Red and gray straps signal proper assembly of the shell and allow easy disassembly 3 Handle enables surface free assembly of the shell 4 Slots in the base allow easy attachment of the base mattress 3 1 1 4 4 2 2 Section 1 Overview ...

Страница 13: ...rea Feature Description 5 Straps slide through slots in the base to attach the base to the base mattress 6 Snaps attach the straps to secure the base to the base mattress 7 The bumper helps properly align the nest for treatment Section 1 Overview 6 7 5 6 5 ...

Страница 14: ...8 The shell provides high intensity phototherapy treatment with blue LED treatment lights 1 3 2 shell shell exterior shell interior 10 9 10 13 13 12 11 8 8 11 14 Section 1 Overview ...

Страница 15: ... indicator light alerts you to an Environment High Temperature Warning See Section 3 4 of this guide for more information The yellow indicator light is not visible unless the bili hut is used in a too hot environment 13 The power cord connects the assembled hut to a safe power supply After the power supply is plugged in to a safe and active outlet the power switch controls whether the bili hut is ...

Страница 16: ...osable The nest properly positions your baby for treatment and improves light array efficacy The nest is disposable for when soiled and between patients Please see the contact information in Section 6 of this gude to order additional nests ...

Страница 17: ...e for when soiled and between patients Please see Section 6 of this guide to order additional nest mattresses 1 3 4 nest mattress disposable Feature Description 15 The dark section of the nest mattress guides proper placement of your baby within the nest Specifically your baby s head and neck are placed entirely within the dark section of the nest mattress 15 ...

Страница 18: ...ure 13 of Section 1 3 2 to a safe and active electrical outlet The power supply is composed of the power brick and AC cord 1 3 5 power supply Feature Description 16 Power brick connects to the bili hut power cord and the AC cord 17 AC cord connects the power brick to a safe and active electrical outlet 16 17 ...

Страница 19: ...t in the home use setting 2 2 Contraindications Little Sparrows Technologies recommends that the bili hut be used for patients with a birthweight of more than 2500 grams 5 5 pounds and with a gestational age of greater than or equal to 35 weeks However the prescribing clinician defines the need for phototherapy with each patient Use the bili hut in these environments recommended room temperature s...

Страница 20: ...s DO NOT operate the bili hut if any of the below are present nitrous oxide an oxygen rich environment a flammable anesthetic mixture of gases flammable cleaning agents Doing so could result in danger to you and or your baby Only use the power supply supplied by Little Sparrows Technologies Using non standard electrical parts may result in undertreatment or electrical shock of your baby Only plug ...

Страница 21: ...d result in over heating of both your baby and the device as well as suffocation of your baby DO NOT use or store the bili hut in direct sunlight Doing so could damage the device or result in over heating of your baby NEVER stack the assembled bili hut on top of other equipment Doing so could result in damage to the device During treatment this could result in injury to your baby DO NOT transport ...

Страница 22: ... equipment should be placed in the bili hut Your baby s water balance may be altered by phototherapy treatment A baby will typically have a wet diaper about every three hours if he or she is well hydrated Wet diapers should be changed so that you can keep track of fluid output Changing wet diapers also prevents your baby from becoming too cold during treatment Note that the reflective interior of ...

Страница 23: ...described in this guide and only for the intended use as specified in Sections 1 1 3 1 and 3 2 Using the bili hut for other purposes may be harmful to you and or your baby The bili hut flaps shield the area around it from the blue treatment lights so that only a small amount of blue light will be seen by you However some people are very sensitive to blue light and may experience discomfort such as...

Страница 24: ...ot already attached pull the base mattress straps through the slots in the base The red trim on the base mattress should face up and align with the side of the base with red straps Secure the snaps 2 Align the red striped shell tab with the matching red straps on the base Attach the magnetic clasps The clasps will click and mechanically lock when in place 3 NOTE The nest may require a short time t...

Страница 25: ... clasps are still in place If any of the four clasps are not in place reference troubleshooting item 8 in Section 5 of this guide Holding the base by the handle align the solid gray tab of the shell with the matching gray straps on the base Attach the magnetic clasps The clasps will click and mechanically lock when in place 4 ...

Страница 26: ...that are cold or cool the air Also DO NOT place the bili hut in extremely low room temperatures Doing so could lead to your baby becoming too cold The Environment High Temperature Warning is NOT caused by cooling sources or low room temperatures WARNING DO NOT place the bili hut on an uneven surface or a surface smaller than 2 x 4 feet 0 6 m x 1 2 m without barriers Doing so could result in injury...

Страница 27: ...embled hut on a smooth sturdy even surface such as a table measuring at least 2 x 4 feet 0 6 m x 1 2 m 5 Alternatively the bili hut can be used in a crib 4 feet 1 2 m 2 feet 0 6 m 6 To assemble the power supply connect the AC cord to the power brick Assembling the power supply ...

Страница 28: ... occurs when a person has poor circulation or is not receiving enough oxygen resulting in blue discoloration of the person s skin WARNING DO NOT put any creams or lotions on your baby s skin before or during treatment Doing so could change the effectiveness of the phototherapy resulting in less treatment for your baby than desired CAUTION DO NOT place items in the assembled hut or nest that could ...

Страница 29: ...3 1 and placed in an appropriate location follow the next six 6 steps Place the nest mattress in the nest so that the dark section of the nest mattress is facing up 1 Place the nest partially into the head end of the assembled hut The dark section of the nest mattress should stick out of the assembled hut 2 ...

Страница 30: ... protecting your baby s eyes using eye protection Treatment without eye protection could damage your baby s vision WARNING Only place a single diapered baby in the bili hut Placing any other objects in the bili hut could result in suffocation of your baby over heating or other injury It could also damage the bili hut WARNING NEVER place your baby in the assembled hut without the nest Only use the ...

Страница 31: ...d Route the power supply and cord in such a way as to not interfere with the operation of the bili hut 5 6 Press the power switch on the power cord to turn on the blue treatment lights Check to make sure the blue treatment lights are on Gently slide the nest into the bili hut until the nest touches the bumper at the foot end of the base mattress Ensure that the shell front flap is pushed down and ...

Страница 32: ...switch on the power cord 1 WARNING Phototherapy may alter your baby s body temperature Therefore check the following every 2 to 4 hours your baby s body temperature your baby s diaper ensure your baby s head and neck lie entirely within the dark section of the nest mattress ensure the Environment High Temperature Warning s yellow indicator light is NOT on CAUTION Phototherapy treatment should only...

Страница 33: ... the nest and place your baby in a safe location Remove your baby s eye protection 2 NOTE Record any treatment interruptions using the bili hut Home Record Sheet WARNING Avoid interrupting treatment unless necessary Resume therapy as soon as possible after the interruption If treatment is interrupted for a long period or is interrupted too frequently it could reduce the effectiveness of the treatm...

Страница 34: ...lowers to a safe range the yellow indicator light will turn off At that time the blue treatment lights will automatically turn back on Follow the flowchart instructions starting at the top of the next page when the Environment High Temperature Warning occurs This warning is visible when the yellow indicator light turns on and the blue treatment lights turn off The Environment High Temperature Warn...

Страница 35: ...TREATMENT The yellow indicator light turns off and the blue treatment lights turn back on Place eye protection over your baby s eyes Place your baby in the nest and gently slide the nest into the assembled hut until the nest touches the bumper at the foot end of the base mattress Wait for the blue treatment lights to turn back on This may take a few minutes The bili hut must be left on during this...

Страница 36: ...tions to remove your baby from the bili hut in Section 3 3 1 Unplug the bili hut from the electrical outlet and disconnect the power supply from the bili hut power cord 2 Completely remove the nest from the assembled hut 3 Dispose of the nest and nest mattress in your trash bin 4 NOTE Record the end of treatment on the bili hut Home Record Sheet WARNING DO NOT disassemble the bili hut while your b...

Страница 37: ...hell from the base 5 Clean the shell base and base mattress according to the instructions in Section 4 1 of this guide 6 Return the bili hut components using the information provided to you by the medical personnel who provided you with the bili hut 7 CAUTION DO NOT store the bili hut near open water such as a tub or sink where it could fall in Doing so could damage the device and or its component...

Страница 38: ...ice Only use the cleaning agents and tools specified in Section 4 1 to clean the bili hut WARNING DO NOT use a soiled bili hut Failure to complete the cleaning described in Section 4 1 could lead to undertreatment skin irritation and or infection of your baby CAUTION Disconnect the bili hut from the power supply when the device is not in use and before cleaning CAUTION DO NOT immerse any bili hut ...

Страница 39: ...onents are clean and dry Use a cleaning agent with one of the following active ingredients quaternary ammonium OR bleach DO NOT use cleaning agents containing ethanol or hydrogen peroxide abrasive cleaning agents or abrasive cleaning tools to clean the bili hut because these may damage the device Follow the instructions provided by the manufacturer of the cleaning agent including any instructions ...

Страница 40: ... to air dry If dirtied wipe down the exterior of the shell DO NOT use excess cleaning agent Allow to air dry 4 2 Disposal Dispose of the nest and nest mattress when soiled and at the end of treatment To dispose of a soiled nest or nest mattress place the item in your trash bin Please see the contact information in Section 6 of this guide to order additional disposable nest packages For questions r...

Страница 41: ...Warning remains on after following the troubleshooting instructions in Section 3 4 Contact Little Sparrows Technologies for assistance 2 Your baby is too cold 1 Remove your baby from the bili hut and warm your baby ideally using skin to skin care 2 If possible adjust the ambient temperature of the room or move the bili hut to a warmer area NEVER place the bili hut near a space heater or other heat...

Страница 42: ...tance 5 The bili hut is not turning on or the light array is not emitting light 1 Check to see if the Environment High Temperature Warning is on If it is on follow the instructions in Section 3 4 2 Ensure the power supply is properly assembled AC cord is fully plugged in to the power brick Ensure the power supply is properly connected to a safe and active outlet and the bili hut power cord 3 Ensur...

Страница 43: ...shell 9 Blue LED treatment lights flicker or substantially increase decrease in brightness 1 Ensure only the power supply supplied by Little Sparrows Technologies for use with the bili hut is used 2 Ensure the power supply is properly assembled AC cord is fully plugged in to the power brick Ensure the power supply is properly connected to a safe and active outlet and the bili hut power cord 3 Ensu...

Страница 44: ...st disposable and 1 nest mattress disposable To contact Little Sparrows Technologies Phone 781 725 2460 Email info littlesparrowstech com Mailing address Little Sparrows Technologies 288 Walnut St suite 300 Newton MA 02460 Website www littlesparrowstech com Twitter TechSparrows Facebook Little Sparrows Technologies Copies of this guide and other instructional materials to be available electronical...

Страница 45: ...Specifications Component PN or REF base base mattress carrier disposable nest package power supply power switch shell IEC Type BF applied part CE EN IEC Class II equipment FDA Class II Direct Current 0106C 0109H NA 0116CPS NA 0102D 0133AFD ...

Страница 46: ...mylar polycarbonate foam Service Life Up to 3 years of continuous use if used with care and within the ranges recommended in this document 7 1 Electrical Power Consumption 20 Watts LED Module Estimated Life Up to 50 000 hours Size of Light Source 16 x 6 inches 40 6 x 15 2 cm bili hut Fuses 3 0A32Vdc and 2 5A40Vdc on DC input Power Supply Fuses 2 0A 250Vac on Line and 2 0A 250Vac on Neutral Degree ...

Страница 47: ...t package Dimensions assembled Materials Polypropylene foam Service Life Single use disposable nest and nest mattress 7 6 bili hut assembled Dimensions 25 x 16 x 12 inches 63 5 x 40 5 x 30 5 cm Weight 8 lbs 3 5 kg Estimated Device Lifetime Up to 3 years of continuous use if used with care and within the ranges recommended in this document Maximum Noise Level 0 5 dB Treatment Distance 8 7 inches 22...

Страница 48: ...be used around high intensity EM disturbances e g HF equipment near a shielded room of an MRI system Internal Temperature of the bili hut that triggers the Environment High Temperature Warning 109 4 F 43 C in accordance with IEC 60601 2 50 Ingress Protection IP23 protects against solid objects over 12 mm and sprays of water from any angle up to 60 from the vertical NOTE The recommended room temper...

Страница 49: ...ations 0 10 20 30 40 50 60 70 80 90 100 400 420 440 460 480 500 520 540 bili hut NormalizedSpectral Irradiance Distribution Wavelength nm Max bili hut Normalized Spectral Irradiance Distribution 7 8 Effects 7 8 1 Wavelength ...

Страница 50: ...ap Total Treatment Area 228 in2 1470 cm2 Effective Treatment Area 170 in2 1097 cm2 Ebi max 57 6 μW cm2 nm 40 Ebi max 23 0 μW cm2 nm Effective Area Average 45 1 μW cm2 nm Measured at a distance of 22 cm from the blue LED treatment lights µW cm 2 nm ...

Страница 51: ...ce The following graph shows the nominal response characteristics of the GE BiliBlanket Light Meter II which corresponds to the peak absorption spectrum of bilirubin The irradiance of every bili hut device is measured with the BiliBlanket Light Meter II at the manufacturer prior to shipment ...

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Страница 53: ...ationalAge 13 H Handle 6 19 Hyperbilirubinemia 1 13 I Indications for Use 13 Intended Use 1 17 Interruptions 26 27 29 Irradiance 43 45 Map 44 M Magnetic clasps 6 9 18 19 31 37 N nest disposable 5 7 10 11 16 18 22 25 27 29 30 33 34 36 38 41 nest mattress disposable 5 11 22 24 26 30 33 34 36 38 41 P power supply 4 9 12 14 17 21 25 30 32 36 37 39 40 Product Responsibility i R Recommendations 13 42 Re...

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