NeoLight SKYLIFE Manual de usuario
SKYLIFETM PHOTOTHERAPY SYSTEM
USER MANUAL
Website: www.theneolight.com
Address:275 N Gateway Drive, Suite #128 Phoenix, AZ 85034
Contact: support@theneolight.com or (480) 626-0304
1 INTRODUCTION 2
2 INTENDED USE 3
3 SKYLIFE SYSTEM COMPONENTS 3
4 EXPLANATION OF SYMBOLS 4
4.1 Warnings & Precauons 5
5 SKYLIFE OPERATING INSTRUCTIONS 6
5.1 Seng up the system 6
5.2 Preparing the baby for phototherapy 8
5.3 Administering phototherapy 9
5.4 Roune maintenance 11
6 CUSTOMER SERVICE AND MAINTENANCE 12
6.1 Customer service 12
6.2 Repair & Maintenance / Alarms 12
6.3 Calibraon 13
6.4 Labeling Standards 13
6.5 Operang condions 13
6.6 Transportaon and storage condions 14
6.7 Expected service life and disposal condions 14
6.8 Replacement parts informaon 14
6.9 Warranty 14
7 TECHNICAL SPECIFICATIONS 15
7.1 Electrical specicaons 15
7.2 Light Distribuon 15
7.3 Physical specicaons 15
7.4 Compliance declaraon 16
7.5 Stabilizaon me
7.6 Guidance & Manufacturer’s Declaraon
16
17
CONTENTS
500007, Rev P, Pg 1
1. INTRODUCTION
The Skylife Phototherapy System is a portable phototherapy device that delivers a narrow band of high-intensity
light via blue light eming diodes (LEDs) to provide treatment for neonatal unconjugated hyperbilirubinemia. The
Skylife system is designed to provide phototherapy treatment from underneath the baby minimizing interference
with other ongoing treatments. The Skylife device must be used within a paent bed, such as a bassinet, an open
crib, a warming table, or incubator and may be used in either hospital or home sengs.
The terms “neonatal” and “neonate” refer to a baby from birth through the rst 28 days of life. The Skylife deviceis
intended for use with all neonatal subpopulaons.
The system ulizes blue LEDs to achieve intensies from 25 µW/cm2/nm to >55 µW/cm²/nm*, eming light in a
narrow bandwidth between 430-475 nm. This light bandwidth corresponds to the spectral absorpon of light by
bilirubin, and is thus considered to be the most eecve for treatment 1,2, 3 . The Skylife system ulizes blue LEDs in
this range to achieve peak intensies between 25 to 35, 35 to 55, and over 55 μw/cm²/nm* at low, high, and very
high sengs.
The Skylife device greatly minimizes the risk of UV exposure typically seen with phototherapy treatment through
the use of Blue LEDs, as this light source does not emit signicant energy in the ultraviolet (UV) spectrum.
However, as with all phototherapy treatment, protecve eye masks must be used to protect the baby’s eyes from
blue light exposure.
Treatment mes can range from hours to weeks and should only be performed under the supervision of a licensed
praconer. Treatment exposures may be applied connuously 24 hours a day or as prescribed by the treang
physician. The Skylife device may be contraindicated for babies with rapidly rising bilirubin levels. Babies with
rapidly rising bilirubin levels must be monitored frequently and may require a more intensive therapy.
Read this User Manual carefully before using the device. Please pay careful aenon to the Safety
Informaon and Warnings throughout the manual.
Cauon: Federal law restricts this device to sale by or on the order of a praconer licensed by the
law of the State in which he/she pracces to use or order the use of the device.
This product is covered by one or more U.S. Patents.
1. Vreman, Hendrik J., et al. “Light-eming diodes: a novel light source for phototherapy.” Pediatric research 44.5 (1998): 804-809.
2. Lee, Kwang-Sun, and Lawrence M. Gartner. “Spectrophotometric characteriscs of bilirubin.” Pediatric research 10.9 (1976): 782-788.
3. Dixon, J. M., M. Taniguchi and J. S. Lindsey (2005), “PhotochemCAD 2. A Rened Program with Accompanying Spectral Databases for
Photochemical Calculaons, Photochem. Photobiol., 81, 212-213.
* Very High seng provides an average intensity of 56.3 μw/cm2/nm over the treatment area with peak intensity at 72.4 μw/cm2/nm.
500007, Rev P, Pg 2
2. INTENDED USE
The Skylife system is intended for the treatment of neonatal unconjugated hyperbilirubinemia. It is designed
to provide phototherapy treatment from underneath the baby. The Skylife unit must be used within a paent
bed, such as a bassinet, an open crib, a warming table or an incubator. The system can be used in a clinical
seng or in the home.
3. SYSTEM COMPONENTS
No. Part Name Descripon
1. Light Bed Top part of main device that emits blue light
2. GelMat Protecve cushion aached to the top of the bed
3. Light Bed Cable Connects device to Skylife controller
4. Light Modules Modules hold the light source inside the Light Bed
5. Controller Allows user to operate/control the device
6. Cloud Swaddle / Cloud
Swaddle Plus
Disposable swaddle that covers the device and ensures hygienic use
for baby
500007, Rev P, Pg 3
4. EXPLANATION OF SYMBOLS
The following symbols are used in this user manual, on the device packaging, on the device and
accessory labeling.
Symbol Descripon
Reference number; part number
Lot number
Serial number
Manufacturing date
Legal Manufacturer name and address
Follow instrucons for use
Prescripon only (USA)
Product contains electrical and electronic
equipment. User should not discard
this product along with other household
waste; it must be collected and treated
separately
Minimum and maximum operang and
storage temperature range
Minimum and maximum storage
humidity range
Minimum and maximum operang
atmospheric pressure range
Symbol Descripon
Type BF applied parts
Cauon
IP23
Protected electrical shock from touch
by hands greater than 12 millimeters.
Protected from water spray less than 60
degrees from vercal
Keep the device away from sunlight
Keep the device dry
Baby Eye Protecon Required
Single use only. Do not reuse.
Hazard of severe electric shock or burn
Non Sterile
Class II equipment
500007, Rev P, Pg 4
4.1 WARNINGS & PRECAUTIONS
1. Use the Skylife Phototherapy System only for its intended use as described in this manual.
2. 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.
3. Always connect the device to a properly grounded outlet. Do not use an extension cord.
4. Always use the Skylifesystem in a crib, bassinet, incubator, or warmer where walls protect the baby from injury.
These environments must have a stable base that does not rock or p, as in the case of a rocking cradle.
5. Avoid using the device adjacent to or stacked on other equipment (except for incubators, warmers, bassinets, or
crib) as it could result in improper operaon.
6. Do not use the device in the presence of ammable substances such as anesthecs, cleaning agents and gases
that support combuson.
7. Do not disassemble the Skylife device unless you are a cered technician.
8. Do not use items such as blankets to cover the device.
9. Do not place the device where it can fall or be pulled into a tub, sink, or other liquid source.
10. Keep the Skylife controller in a locaon that is inaccessible to the baby.
11. Keep the Skylife controller and cords in a locaon away from toddlers, children and pets.
12. The Skylife Light Bed and GelMat must be used only with the Cloud Swaddle / Cloud Swaddle Plus provided. Any
other type of cover may cause a reducon in light intensity.
13. Baby eye protecon is required prior to turning on the Skylife unit.
14. If the user should experience discomfort from exposure to blue LED light, eye protecon is recommended
(yellow lenses) while operang the unit .
15. Baby should be wearing only a diaper and not otherwise wrapped or clothed during treatment.
16. Ensure baby is secured during treatment.
17. Ensure that device cords and any other equipment cords are outside treatment area and do not pose an
entanglement, strangulaon, or tripping hazard.
18. Do not operate the Skylife unit in temperatures above 37oC (98.6oF). Keep the device away from heated
surfaces, heaters, and other heat sources (like replaces or warming blankets).
19. Do not use the device while bathing or feeding the baby.
20. During phototherapy, the baby’s water balance may become disturbed. Before and during treatment, make sure
the baby is properly hydrated and that his or her body temperature is maintained.
21. During phototherapy, monitor baby’s bilirubin levels according to your praconer’s recommendaons.
22. The Skylife device should be turned o prior to evaluang baby’s skin color, as lighng will eect visual color
evaluaon. Parents should contact their medical praconer if needed.
23. Turn o and unplug the unit during device servicing.
24. If the Light Bed is exposed to liquid (falling into water or uid is spilled on the device), immediately unplug the
unit from the power source prior to taking any other acon. Disconnue use of the device immediately.
25. Store the device in dry locaon away from direct sunlight. Avoid exposure to dust, lint or other parculates.
26. Do not place heavy objects on the Light Bed. This can damage the panel and may aect light output.
27. Do not place sharp objects on any element of the deviceas it may cause damage.
28. Do not drop the device. If the system is dropped, contact your hospital technician or the manufacturer for
further informaon prior to resuming use of the Skylife unit.
29. Ensure that the device is inaccessible to children or pets when not in use.
30. Handle GelMat with care. Do not stretch, twist, or fold the GelMat.
31. Keep sharp objects away from GelMat.
32. Do not clean the Light Bed top surface with any liquids. Use dry cloth wipes only on the cloudy area
of the Light Bed.
33. Due to photo eects, drugs should not be stored in treatment area.
34. Not for use with babies greater than 10kg (22 lbs).
35. Do not use the Skylife system without GelMat and Cloud Swaddle, or place baby directly on the Light Bed.
36. Always ensure to rmly secure the neonate’s arms, legs, and body using use Cloud Swaddle Plus.
500007, Rev P, Pg 5
5. SKYLIFE OPERATING INSTRUCTIONS
(Steps 1 - 6 are applicable in both home and hospital sengs.)
5.1 SETTING UP THE SYSTEM
1 Place the Skylife device in a locaon with walls
(e.g. bassinet, warmer, crib, or incubator).
Cauon: Do not allow items such as blankets to cover
the outside edges of the device.
2Visually inspect Light Bed and GelMat
for damage or wear. If GelMat becomes
damaged, torn, or develops a yellowish
discoloraon, refer to secon 6.2, steps
#1 - 4 for replacement informaon. A home
user should contact the system provider for
replacement.
Place the Cloud Swaddle on the device
over the GelMat. Secure the Cloud Swaddle
to the device using the corner pockets like a
ed bed sheet.
3
Aach the Controller and Power Supply
to the device and place the Controller
outside the enclosing walls of the treatment
area. Ensure that the cord does not pose a
hazard to the baby. Plug the Power Supply
into the wall outlet.
4
500007, Rev P, Pg 6
Light Sensor
500007, Rev P, Pg 7
(Steps 5 - 6 are applicable in a hospital seng only, including
technical references on this page.)
5 Prior to placing the baby on the device, turn on the
device to the desired treatment level(s). To check the
light intensity, follow instuonal pracces.
The device has been calibrated to deliver the
following light Intensity levels
Low 30 ± 5 µW/cm²/nm
High 45 ± 10 µW/cm²/nm
Very High >55 µW/cm²/nm*
Cauon: If device does not meet the desired intensity range for treatment, replace GelMat
and repeat setup. If device sll fails to meet the required levels contact Customer Service.
Warning: Varying ambient lighng (including exposure to sunlight and other
photoradiaon sources) and varying temperature condions may aect paent response to
treatment, monitor paent closely.
Recommended Spectrophotometer Specicaons
Recommended Model Ohmeda Medical
BiliBlanket Meter
Spectral Response 400-520 nm
Center Wavelength 450 nm
Bandwidth 60 nm
Light Acceptance Angle
Cosine Characteriscs
±2% @ 30° angle
±7% @ 60° angle
±25% @ 80° angle
Receptor Type Silicon Photocell
Measuring Funcon Spectral Irradiance
μW•cm-2•nm-1
Accuracy Within ± 3% of reading ±1
digit in the last posion
6 Measurements should be taken on the surface of
the GelMat. The Cloud Swaddle must be on the device
when taking readings and be sure to focus the light
sensor towards the GelMat.
* Very High seng provides an average intensity of 56.3 μw/cm2/nm over the treatment area with peak intensity at 72.4 μw/cm2/nm.
5.2 PREPARING BABY FOR PHOTOTHERAPY
1Before starng treatment, always shield the
baby’s eyes with a protecve eye mask
designed for use during phototherapy. During
phototherapy treatment, regularly remove the
coverings according to hospital policy to assess
the baby’s eyes for signs of irritaon or infecon.
Important! Eye Protecon: Do not look directly
into the blue light for a prolonged period of me.
3 To power on the device, press and
hold the power buon on the controller
unl you hear a beep and the lights
come on.
2 Posion the baby on the Cloud Swaddle.
Ensure that only the Cloud Swaddle is directly
under the baby. Do not use blankets, swaddles,
bumpers, etc. to cover the device.
Important: During treatment, always ensure
to completely secure the neonate using Cloud
Swaddle Plus
500007, Rev P, Pg 8
The device has been calibrated to deliver the
following light Intensity levels:
Low 30 ± 5 µW/cm²/nm
High 45 ± 10 µW/cm²/nm
Very High >55 µW/cm²/nm*
5.3 ADMINISTERING PHOTOTHERAPY TREATMENT
Normal use cycle:
Press and hold power buon unl a
beep is heard to start device. NOTE:
Soware version may dier than
version displayed above.
The device is now ready for use.
Press ‘+’ buon once to begin treatment.
Use ‘+’ and ‘-’ buons to increase or
decrease light intensity. LED indicators will
glow to show corresponding levels. Keep
device at a seng recommended by the
treang physician.
To pause treatment, press power buon
once. To resume treatment, press power
buon once again.
Press hold the power buon for a longer
duraon to power OFF the device.
* Actual display may vary based on soware revisions.
** LED lifeme refers to the number of hours the LED modules have been used to date.
Once baby is secure, turn on the device and use the controller to administer therapy. Follow the steps below and
set light intensity level as directed by physician to achieve desired results*.
SELF TEST PASSED LED LIFETIME
2,435 HRS
System performs self-check and buzzer
beeps if passed. In case of failure, a sys-
tem alarm is generated, refer to secon
for 6.2 for more informaon.
System will display LED lifeme**.
Verify that the me is less than 25,000
hrs.
NEOLIGHT SKYLIFE PHOTOTHERAPY
VERSION 1.0
500007, Rev P, Pg 9
Otros manuales para SKYLIFE
3
Este manual sirve para los siguientes modelos
1
Tabla de contenidos
Otros manuales de Equipo médico de NeoLight
