Little Sparrows Technologies Bili-hut Home Operating manual

bili-hut™ Home Use Guide
Little Sparrows
Big ideas for little babies
Technolog es

Copyright © November 2021
Little Sparrows Technologies
288 Walnut 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.

Product Responsibility
The bili-hut™ was designed by Little Sparrows
Technologies. This guide provides information on how to
assemble, operate, disassemble, clean, and store the
bili-hut™. Follow all instructional materials and labels
provided with the bili-hut™. Check this device regularly
for defects. NEVER use a bili-hut™ or any bili-hut™
components that appear 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™ labels,
or other instructional materials prepared by Little Sparrows
Technologies.
See Section 5 for instructions on troubleshooting problems
with the bili-hut™.
i

Table of Contents
ii
Product Responsibility..............................................................................................i
Label Symbols Key................................................................................................iii
1.Overview..............................................................................................................1
1.1 Intended Use...............................................................................................1
1.2 Introduction..................................................................................................1
1.2.1 Purpose of this Guide........................................................................1
1.2.2 What is Jaundice?..............................................................................1
1.2.3 What is Bilirubin?...............................................................................1
1.2.4 What is Phototherapy?.......................................................................2
1.2.5 What is the bili-hut™?......................................................................2
1.3 Components................................................................................................4
1.3.1 base and base mattress...................................................................6
1.3.2 shell...................................................................................................8
1.3.3 nest (disposable)...........................................................................10
1.3.4 nest mattress (disposable)............................................................11
1.3.5 power supply..................................................................................12
2. Safety................................................................................................................13
2.1 Indications for Use....................................................................................13
2.2 Contraindications.......................................................................................13
2.3 Recommendations....................................................................................13
2.4 General Warnings......................................................................................14
2.4.1 Electrical Warnings..........................................................................14
2.4.2 Environmental Warnings..................................................................14
2.4.3 Warnings About Your Baby..............................................................16
2.5 General Cautions.......................................................................................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 Cleaning the base and base mattress...........................................34
4.2 Disposal.....................................................................................................34
5. Troubleshooting................................................................................................35
6. Contact and Reorder Information......................................................................38
7. Specications...................................................................................................39
7.1Electrical....................................................................................................40
7.2 shell.........................................................................................................40
7.3 base..........................................................................................................40
7.4 base mattress..........................................................................................41
7.5 disposable nest package........................................................................41
7.6 bili-hut™ (assembled)..............................................................................41
7.7 Environmental...........................................................................................42
7.8 E󰀨ects.......................................................................................................43
7.8.1 Wavelength......................................................................................43
7.8.2 Irradiance Map.................................................................................44
7.8.3 Spectral Sensitivity of the Irradiance Measurement Device...........45
Index....................................................................................................................47

iii
Label Symbols Key
Symbol Meaning
Cautions draw your attention to any hazards
that could damage the device or could result in
severe but reversible injury to you and/or your
baby.
Warnings 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

Section 1: Overview
1.1 Intended Use
The intended use of the bili-hut™ is for the treatment of
neonatal hyperbilirubinemia.
Use the bili-hut™ only as directed by your healthcare
provider. Not doing so may result in too much or too little
treatment for your baby.
The bili-hut™ is not intended to prevent the onset of
jaundice.
1.2 Introduction
The purpose of this guide is to show you how to use the
bili-hut™ to treat your 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 naturally in the body
as a product of red blood cells, which break down over time.
Bilirubin is normally broken down by the liver and passed out
of the body through urine and stool.
1.2.3 What is Bilirubin?
Section 1: Overview
1

Phototherapy exposes a jaundiced baby’s skin to a bright
blue LED (Light Emitting Diode) light. The light converts
bilirubin in the blood into a form that can naturally pass
through the body. Nearly all babies with jaundice can be
treated with phototherapy.
1.2.4 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 e󰀨ective treatment in
either the clinical environment or home when used as
instructed.
Section 1: Overview
2

4
Section 1: Overview
1.3 Components
assembled hut
base
base mattress
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

5
Section 1: Overview
nest components
nest
nest mattress
nest mattress nest

6
The base maintains the structure of the shell during
treatment.
1.3.1 base and base mattress
Feature # Description
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

7
The base mattress cushions and aligns the treatment area.
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
75
6
5

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
88
11
14
Section 1: Overview

9
Section 1: Overview
Feature # Description
8 Magnetic clasps on the shell pair with the
base clasps for secure attachment.
9Blue LED (Light Emitting Diode) treatment
lights form the light array to administer
high-intensity phototherapy to your baby.
10 Back and front aps focus light on the
treatment area. The aps also shield the area
around the bili-hut™ so that you will only see
a small amount of blue light.
11 Red and gray tabs indicate proper shell
assembly.
12 The yellow 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 “ON” or “OFF”. A small blue
indicator light on the power switch illuminates
when the power cord is plugged in and the
power switch is in the “ON” position.
14 The timer tracks the total use of the blue LED
treatment lights in hours. The timer does NOT
track individual treatment times.

10
Section 1: Overview
1.3.3 nest (disposable)
The nest properly positions your baby for
treatment and improves light array e󰀩cacy. 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.

11
Section 1: Overview
The nest mattress provides cushioning for
your baby and uses color-blocking to guide
placement of your baby. The nest mattress
is disposable 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.
Specically, your baby’s head and neck are
placed entirely within the dark section of the
nest mattress.
15

12
Section 1: Overview
The medical-grade power supply attaches the bili-hut™
power cord on the shell (see Feature #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

13
Section 2: Safety
Section 2: Safety
The bili-hut™ provides phototherapy for the treatment of
neonatal hyperbilirubinemia, commonly known as neonatal
jaundice, during the newborn period in the clinical or home
setting.
2.1 Indications for Use
Contraindications are conditions when the bili-hut™ should
not be used because the risks outweigh the benets of using
it.
There are no known contraindications for the bili-hut™ 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
denes the need for phototherapy with each patient.
Use the bili-hut™ in these environments:
• recommended room temperature: select a location
where the room temperature can be maintained
between 70°F and 76°F (21.1° C and 24.4°C) for your
baby’s comfort and safety during treatment
• humidity range: 10 to 90% rH non-condensing
2.3 Recommendations

14
Section 2: Safety
Warnings describe serious adverse reactions and potential
safety hazards, limitations in use imposed by them, and
steps that should be taken if they occur. General warnings
are listed in this section. Specic warnings are listed with the
relevant device use instructions.
2.4 General Warnings
2.4.1 Electrical Warnings
2.4.2 Environmental Warnings
DO NOT operate the bili-hut™ if any of the below
are present:
• nitrous oxide
• an oxygen-rich environment
•a ammable anesthetic mixture of gases
•ammable 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 the bili-hut™ into a properly grounded
electrical outlet. Plugging the bili-hut™ into an
unsafe outlet could result in malfunction of the
device or injury to your baby.