NeoLight SKYLIFE User manual

© 2022 by NeoLight LLC.
All rights reserved.
Page 1 of 43
500050 Rev A
Skylife™Infant Phototherapy System
Service Manual
Service Manual English
500050 Rev A
© 2021 by NeoLight LLC.
All rights reserved.

© 2022 by NeoLight LLC.
All rights reserved.
Page 2 of 43
500050 Rev A
Caution: Federal Law (U.S.) restricts this device to sale or use by or on the order of a physician (or properly
licensed practitioner).
Skylife is a registered trademark of NeoLight LLC
© 2021 by NeoLight LLC. All rights reserved.
This manual may not be reprinted or copied in whole or in part without written consent from NeoLight
LLC. The content of this manual may change without notice.
NeoLight LLC
1475 N Scottsdale Rd,
Suite 110,
Scottsdale, AZ 85257
Customer Support: [phone]x 1
Technical Support: [phone]x 2

© 2022 by NeoLight LLC.
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Page 3 of 43
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Table of Contents
Contents
Table of Contents...............................................................................................................................................................3
User Responsibility ............................................................................................................................................................4
Chapter 1: About this Manual .........................................................................................................................................6
1.1 Indications for Use..................................................................................................................................................6
1.2 Intended Users ........................................................................................................................................................6
1.3 Purpose .....................................................................................................................................................................6
1.4 Product Description ...............................................................................................................................................6
Chapter 2: Safety Information .........................................................................................................................................7
2.1 Symbols.....................................................................................................................................................................7
2.2 Warnings...................................................................................................................................................................9
Chapter 3: Components and Controls ........................................................................................................................ 12
3.1 System Components: .......................................................................................................................................... 13
Chapter 4: Routine Maintenance Procedures ........................................................................................................... 18
4.1 Assembling and Disassembling Skylife ............................................................................................................ 18
4.2 Cleaning and Disinfection Procedure (for both professional and home use): ......................................... 20
4.3 Performance Verification ................................................................................................................................... 22
4.4 Replacing the GelMat.......................................................................................................................................... 24
4.5 Replacing Light Modules .................................................................................................................................... 26
4.6 Logging the Light Module Use-life................................................................................................................... 28
4.7 Homecare Providers............................................................................................................................................ 30
Chapter 5: Troubleshooting .......................................................................................................................................... 31
Chapter 6: Accessories and Replacement Parts........................................................................................................ 36
Chapter 7: Product Specification ................................................................................................................................. 37
Chapter 8: Technical Reference ................................................................................................................................... 38
Chapter 9: Compliance Declaration............................................................................................................................. 39
Chapter 10: Warranty .................................................................................................................................................... 41
Customer Service:....................................................................................................................................................... 41
Appendix A: Service Guide - System Evaluation....................................................................................................... 42
Appendix B: Service Guide - GelMat and Light Module Use-life Log .................................................................. 43

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© 2022 by NeoLight LLC.
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Page 5 of 43
500050 Rev A
User Responsibility
Skylife will perform in conformity with the description contained in the instructions for use, service
manual, and accompanying labels and/or guides, when assembled, operated, maintained, and repaired in
accordance with the instructions provided. This Product must be checked periodically. 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, NeoLight recommends
making a service request by contacting Customer Service. This Product or any of its parts should not be
repaired other than in accordance with written instructions provided by NeoLight and by NeoLight trained
personnel. The Product must not be altered without NeoLight's prior written approval. NeoLight LLC is not
responsible for any damages or consequences resulting from unauthorized attempts to open, modify, or
repair the device. This unauthorized service of the Product also voids the warranty.
The user of this product shall have the sole responsibility for any malfunction that results from improper
use, faulty maintenance, improper repair, damage, or alteration by anyone other than NeoLight. The user is
also responsible for ensuring the manual version they reference is the most up-to-date and that the
instructions and requirements are followed. Service Maintenance can only be performed by a Biomed
technician or other medical professional. The components of the Skylife System must be replaced as
directed for the proper function of the system. Please complete service checks listed in Appendix A every
half a year (6 months) to ensure all components of the Skylife device are correctly functioning, and
replacements are made accordingly.
CAUTION:
U.S. Federal law restricts this device to sale by or on the order of a licensed medical
practitioner.

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500050 Rev A
Chapter 1: About this Manual
1.1 Indications for Use
Skylife is intended for the treatment of neonatal unconjugated hyperbilirubinemia. It is designed to provide
phototherapy treatment from underneath the baby. Skylife must be used within a patient enclosure, such
as a bassinet, an open crib, a warming table, or an incubator. Skylife can be used in a clinical setting or in
the home.
1.2 Intended Users
This device should only be operated by health care providers or others designated by health care
providers* who are trained in its operation and familiar with the risks of this type of device.
1.3 Purpose
The service manual provides a complete guide on troubleshooting and maintaining the Skylife Infant
Phototherapy System.
1.4 Product Description
Skylife is a portable phototherapy light system that delivers a narrow band of high-intensity blue light via
blue light-emitting diodes (LEDs) to provide treatment for neonatal unconjugated hyperbilirubinemia.
Skylife is designed to provide phototherapy treatment from underneath the baby. The system must be
used within a patient enclosure, such as a bassinet, an open crib, a warming table, or an incubator.
Skylife utilizes blue LEDs to achieve intensities from 25 μW/cm2/nm to > 55 μW/cm2/nm, emitting light in
a narrow bandwidth between 430-475 nm. This light bandwidth corresponds to the spectral absorption of
light by bilirubin. SkylifeTM utilizes blue LEDs in this range to achieve peak intensities between 25 to 35,
35 to 55, and over 55 μW/cm2/nm at Low, High, and Very High settings. Skylife at the Very High setting
provides an average intensity of 56.3 μW/cm2/nm over the treatment area with a peak at 72.4
μW/cm2/nm.
Treatment is intended to be applied until the bilirubin levels have dropped sufficiently that the child no
longer has jaundice as determined by the attending physician. Phototherapy treatment of neonatal
jaundice using Skylife can be applied at home or in a hospital.
* Such as those using the product through DME groups

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Chapter 2: Safety Information
2.1 Symbols
The following symbols are used in this Service Manual, on the device packaging, on the device, and
accessory labeling.
Symbol
Description
Reference Number; Part Number
Catalog Identification
Lot Number
Serial Number
Manufacturing Date
Legal Manufacturer Name
Follow Instructions for Use
Prescription-only (USA)
The product contains electrical equipment. Therefore, users should not
discard this product along with other household waste.
Minimum and maximum operating and storage temperature range
Minimum and maximum storage humidity range
Minimum and maximum operating atmospheric pressure range.
Type B.F. Applied parts
CAT

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500050 Rev A
Symbol placed next to CAUTION or WARNING to alert the users to
important statements.
IP23
Protected Electrical shock from touch by hands greater than 12 millimeters.
Protection from water sprays less than 60 degrees from vertical.
Keep the device away from sunlight.
Keep the device dry.
Cover patient's eyes during phototherapy.
Single-use only. Do not reuse.
Hazard of severe electric shock or burn
Non Sterile
Class II Equipment
WARNING
A WARNING statement is used when the possibility of injury exists.
CAUTION
A CAUTION statement is used when the possibility of damage to the
equipment exists.
IMPORTANT!
Instruction provided to help ensure correct clinical results and provide
quality assurance to the phototherapy procedures.
NOTE
Background information provided to clarify a particular step or procedure.
Information in this category is not considered precautionary

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2.2 Warnings
It is important to know and understand the safety measure before using the phototherapy device. The
precautions mentioned below prevent possible risk of injury to the patient or the operator and ensure
correct equipment usage.
WARNING:
Use the Skylife Phototherapy System only for its intended use as described in this manual
WARNING:
Never operate the system if it has a damaged plug, damaged or frayed power cord, or
wires. Do not insert anything into the end of the plug.
WARNING:
Always use the Skylife system in a crib, bassinet, incubator, or warmer where walls protect
the baby from injury.
WARNING:
Do not use the device in the presence of flammable substances such as anesthetics,
cleaning agents, or gases that support combustion.
WARNING:
Keep the Skylife controller in a location that is inaccessible to the baby.
WARNING:
Keep the Skylife controller and cords in a location away from toddlers, children, or pets.
WARNING:
The Skylife Light Bed and GelMat must be used only with the Skylife Disposable Swaddles.
Any other type of cover may cause a reduction in light intensity.
WARNING:
Baby eye protection is required before turning on the Skylife unit.
WARNING:
If the user should experience discomfort from exposure to blue LED light, eye protection is
recommended (yellow lenses) while operating the unit.
WARNING:
The baby should be wearing only a diaper and not otherwise wrapped or clothed during a
treatment.
WARNING:
Ensure baby is secured during treatment.
WARNING:
Ensure that device cords and other equipment cords are outside the treatment area and do
not pose an entanglement, strangulation, or tripping hazard.
WARNING:
Do not use the device while bathing or feeding the baby.
WARNING:
During phototherapy, the baby's water balance may become disturbed. Therefore, before
and during treatment, ensure the baby is adequately hydrated and that their body
temperature is maintained.

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WARNING:
Monitor the baby's bilirubin levels during phototherapy according to your practitioner's
recommendations.
WARNING:
The Skylife device should be turned off before evaluating the baby's skin color, as lighting
will affect visual color evaluation. Parents should contact their medical practitioner if
needed.
WARNING:
Due to photo effects, drugs should not be stored in the treatment area.
WARNING:
Do not use the Skylife system without GelMat and Skylife Disposable Swaddles, or place
baby directly on the Light Bed.
WARNING:
Always ensure to firmly secure the neonate's arms, legs, and body using the Cloud
Swaddle Plus.
CAUTION:
Always connect the device to a properly grounded outlet. Do not use an extension cord.
CAUTION:
Avoid using the device adjacent to or stacked on other equipment (except incubators,
warmers, bassinets, or crib) as it could result in improper operation.
CAUTION
Do not disassemble the Skylife device unless you are a certified technician following
NeoLight service instructions.
CAUTION
Do not use items such as blankets to cover the device.
CAUTION:
Do not place the device where it can fall or be pulled into a tub, sink, or other liquid
sources.
CAUTION:
Do not operate the Skylife unit in temperatures above 37°C (98.6°F). Keep the device
away from heated surfaces, heaters, and other heat sources (like fireplaces or warming
blankets).
CAUTION:
Turn off and unplug the unit during device servicing.
CAUTION:
If the Light Bed is exposed to liquid (falling into water or fluid is spilled on the device),
immediately unplug the unit from the power source before taking any other action.
Discontinue use of the device immediately.
CAUTION:
Store the device in a dry location away from direct sunlight. Avoid exposure to dust, lint, or
other particulates.
CAUTION:
Do not place heavy objects on the Light Bed. This can damage the panel and may affect
light output.

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CAUTION:
Do not place sharp objects on any device element as it may cause damage.
CAUTION:
Do not drop the device. If the system is dropped, contact your hospital technician or the
manufacturer for further information before using the Skylife unit.
CAUTION:
Ensure that the device is inaccessible to children or pets when not in use.
CAUTION:
Handle GelMat with care. Do not stretch, twist, or fold the GelMat.
CAUTION:
Keep sharp objects away from the GelMat
CAUTION:
Do not clean the Light Bed top surface with any liquids. Instead, use dry cloth wipes only
on the cloudy area of the Light Bed.
CAUTION:
Not for use with babies greater than 10 kg (22 lbs.).

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Chapter 3: Components and Controls
3.1 System Components:
1. Light Bed
The Light Bed is the device's body that houses the light sources and
provides a surface to position the patient.
a. GelMat
b. GelMat Placement Indicator
Stickers
c. Handles for Light Bed
2. GelMat
This is a soft transparent gel mattress attached to the top plastic
enclosure of the Light Bed. The mattress helps distribute pressure
underneath the body prominences of the baby to offer comfort.
3. Controller
The Controller allows the operator to turn the device on/off and set the
treatment dosage.
4. AC/DC Adapter
This module converts A.C. power to DC power
c
b
a
6
4
3
9
1
2
10
8
5
5
7

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5. Light Modules
The two Light Modules house 7 LEDs that provide the therapy
a. Light Module Bank Data Port
b. Thermostat Port
c. Light Module Printed Circuit
Board (PCB)
d. LEDs
6. Power Cord
This cord plugs into the electrical outlet
7. Power and Data Cable
This cable connects the Controller and the Light Bed. It carries power
and data signals to operate the device.
8. Vent Holes
a. Provide ventilation for the
thermal management of the
Light Modules
b. Feet to elevate the Light Bed
a
b
a
b
c
d
d
d
d
d
d
d
d

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9. Keypad
The Keypad mounted on the Controller has buttons that allow the
device the turn on/off and adjust treatment dosage
a. On/Off Button
f. Warning Indicator light
b. Increase Light Intensity
g. Treatment setting Indicator
c. Decrease Light Intensity
h. LCD Display
d. Access to System Settings
i. Removable Controller
connector
e. Power Indicator light
10. Diffuser
Channels the LED light to create a uniform Treatment / Effective
Surface Area. It's located beneath the GelMat.
11. Skylife Disposable
Swaddle: CloudCover
A disposable product that fits the Light Bed isolates it from the
neonate.
a
b
c
d
f
g
e
h
i

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500050 Rev A
12. Skylife Disposable
Swaddle: CloudCover Plus
A disposable product that fits on the Light Bed firmly holds the
neonate.
Note: Velcro is highlighted in Blue only visualization purposes. The fully
engaged CloudCover Plus is shown below.
1
2
3
5

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13. Skylife Carrying Case
High-density plastic case with foam inserts to carry Skylife conveniently
for administering Home Phototherapy
14. Skylife Travel Case
High-density plastic case with foam inserts, rollers, and telescopic
handles to carry Skylife safely and conveniently for administering Home
Phototherapy. The case also comes with a TSA approved padlock

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500050 Rev A
Chapter 4: Routine Maintenance Procedures
This chapter includes procedures for routine maintenance of the Skylife system. These procedures may be
performed after any of the following events and/or as prescribed by the institution's maintenance
schedule:
•Initial receipt of the Skylife at the institution.
•Skylife has been visually damaged or subjected to mechanical shock (e.g., dropped).
•Skylife has been submitted for maintenance or scheduled performance verification.
IMPORTANT!
Routine maintenance should be performed according to each section's requirements.
Cleaning and disinfection should occur between patients or if the Skylife Disposable
Swaddles are soiled or damaged.
IMPORTANT!
The routine maintenance must be performed at the time of replacing the GelMat every
6 months, 1,500 hours of use, or if damaged, whichever comes first
NOTE:
Please record the Light Module hours of use in our Service Guide in Appendices A & B,
when the GelMat is replaced. Also, please follow the instructions for each section
closely to prevent damage or harm.
4.1 Unpacking and Packing Skylife
1. Skylife is shipped in the
following shown packaging
schema. Please save all the
boxes after unpacking for
future shipment of Skylife
for possible service and
repair activity.

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500050 Rev A
2. Unpack the device and place it on an uncluttered and non-abrasive surface or inside a four-walled
enclosure for treatment
3. Connect the Controller and
Light bed Power and Data
Cable.
a: Light Bed Cable
b: Ensure the Arrow is
facing up when connecting
IMPORTANT!
When disconnecting, pull
the sleeve to properly
disconnect the cable from
the port to avoid damaging
the connection lock.
a: Sleeve
IMPORTANT!
Disconnect the Controller
from the Light Bed only
when the device has to be
packaged for shipment.
b
a
a

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Place the disposable on the
device. Hold the ends of a
longer edge and slide the
distal end beneath the
device as shown. Using the
Skylife to secure the distal
end, pull the proximal end
and slide it beneath the
device.
NOTE:
Ensure that the disposables do not cover the vents
4. Connect the power cord to the electrical outlet
5. Using the Controller, ensure that Skylife can be turned on/off, the light intensity can be
increased/decreased, and the treatment can be paused/un-paused.
WARNING!
During this procedure, ensure that the Controller beeps for each button press. Contact
NeoLight if the Controller does not provide this audible feedback.
4.2 Cleaning and Disinfection Procedure (for both professional and home use):
It is recommended to use Super Sani-Cloth®; however, similar quaternary ammonium disinfectants can be
used provided they have similar Isopropyl Alcohol concentration around 55%, Quaternary ammonium
compounds concentration of 0.25%, and n-Alkyl Dimethyl Benzyl Ammonium Chloride concentration
around 0.25%.
CAUTION:
Unplug the device. Always turn off and disconnect the device from the power outlet
before cleaning.
CAUTION:
Skylife consists of the Lightbed with a controller, GelMat, Skylife Disposable Swaddles, and
the Power Supply. Only the Light Bed, GelMat, and Power Supply are designed to be
reused.