natus neoBLUE User manual

User Manual
(Revision Date 2020-05-27)

neoBLUE® blanket LED Phototherapy System User Manual 2
PN 029142 Rev A
Federal Law (U.S.) restricts this device to sale or use by or on the order of a physician (or properly licensed
practitioner).
Natus, Biliband and neoBLUE are registered trademarks of Natus Medical Incorporated.
© 2020 Natus Medical Incorporated. All rights reserved.
This manual may not be reprinted or copied in whole or in part without written consent from Natus
Medical Incorporated. The content of this manual may change without notice.
Natus Medical Incorporated
5900 First Avenue South
Seattle, WA 98108 USA
Telephone [phone]
Fax [phone]
Technical Service [phone]
E-mail: [e-mail]
Customer Service [phone]
Customer Service Fax [phone]
E-mail: customer[email protected]
International Support - Please contact your local Distributor.
Distributor locations can be found at www.natus.com
Natus Manufacturing Limited
IDA Business Park
Gort, Co.Galway
Ireland
2797

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TABLE OF CONTENTS
1. PRODUCT DESCRIPTION........................................................................................................................................5
1.1. Intended Use: ...................................................................................................................................................5
1.2. Indications for Use:...........................................................................................................................................5
1.3. Patient Population:...........................................................................................................................................5
1.4. Physical Characteristics ....................................................................................................................................5
1.5. Power Requirement Information .....................................................................................................................6
1.6. Contraindications .............................................................................................................................................6
2. SAFETY INFORMATION...........................................................................................................................................6
2.1. Explanation of Terminology..............................................................................................................................6
2.2. General Safety Information ..............................................................................................................................6
2.3. Safety Symbols .................................................................................................................................................7
3. COMPONENTS AND USER CONTROLS...............................................................................................................12
3.1. neoBLUE blanket LED Phototherapy System..................................................................................................12
3.2. Light Box .........................................................................................................................................................12
3.3. Fiberoptic Blanket ..........................................................................................................................................13
3.4 Controls ..........................................................................................................................................................13
3.5 Pole-Mounting Hardware (optional) ..............................................................................................................14
4. ASSEMBLY AND OPERATING INSTRUCTIONS ..................................................................................................15
4.1. Preparing the neoBLUE blanket LED Phototherapy System for use:..............................................................15
4.2. Administering phototherapy treatment:........................................................................................................15
5. TROUBLESHOOTING GUIDE ................................................................................................................................17
6. ROUTINE CLEANING AND MAINTENANCE.........................................................................................................18
6.1. Checking the Light Intensity ...........................................................................................................................18
6.2. Adjusting the Light Intensity...........................................................................................................................18
6.3. Cleaning..........................................................................................................................................................18
7. TECHNICAL REFERENCE .....................................................................................................................................20
8. SPECIFICATIONS...................................................................................................................................................21
8.1. Light Source ....................................................................................................................................................21
8.2. Power Supply Specifications...........................................................................................................................21
8.3. Safety..............................................................................................................................................................21
8.4. Dimensions .....................................................................................................................................................21

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8.5. Environmental ................................................................................................................................................22
8.6. Safety Standards.............................................................................................................................................22

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1. Product Description
The neoBLUE®blanket LED Phototherapy System consists of five components: the neoBLUE
blanket phototherapy light box, the fiberoptic blanket with cable, the blanket mattress, the
disposable mattress covers and the power supply.
Before assembling the neoBLUE blanket device and administering phototherapy, read all
sections of this manual carefully. There are safety considerations that should be read and
understood before use.
1.1. Intended Use:
The neoBLUE blanket LED Phototherapy System is intended for the treatment of
unconjugated hyperbilirubinemia in premature babies and neonates. It is intended for use with
patients up to 3 months of age, weighing less than 22 lb (10 kg).
1.2. Indications for Use:
The neoBLUE blanket LED Phototherapy System is indicated for the treatment of
unconjugated hyperbilirubinemia in a hospital environment, and administered by trained
professional medical staff, on the order of a physician, or in the home environment
administered by a trained caregiver. The neoBLUE blanket device provides intensive
phototherapy underneath the patient and can be used with a bassinet, open bed, radiant
warmer, incubator, or while holding the patient.
1.3. Patient Population:
When treating term and near-term neonates with intensive phototherapy for treatment
guidance, please refer to the AAP Guidelines (American Academy of Pediatrics Clinical
Practice Guideline –Management of Hyperbilirubinemia in the Newborn Patient 35 or More
Weeks of Gestation).
When treating preterm neonates with intensive phototherapy, please seek guidance from
physician on duration of the treatment as well as appropriate patient monitoring.
Note: Under the direction of a physician, the neoBLUE blanket device may be used in the
home environment. Refer to your hospital policy and procedure regarding user training for
caregiver and service of the device when used at home.
The caregiver must be provided with the ‘neoBLUE blanket Guide for Home Use’ for adequate
use of the device and must follow the direction provided by physician for duration of the
treatment.
1.4.Physical Characteristics
The neoBLUE blanket device is a portable phototherapy light that delivers a narrow band of
high-intensity blue light via a blue light emitting diode (LED) to provide treatment for
unconjugated hyperbilirubinemia.
Light Source
The blue LED emits light in the range of 400 –550 nm (peak wavelength 450-475 nm). This
range corresponds to the spectral absorption of light by bilirubin and is thus considered to be
the most effective for the degradation of bilirubin. The blue LED does not emit significant
energy in the ultraviolet (UV) region of the spectrum, so there is no concern about UV
exposure to the patient. As with all phototherapy lights, protective eyeshades such as the
Natus Biliband® Eye Protectors must be used to protect the patient’s eyes from excessive
light exposure.
The LED has minimal light output degradation over its lifetime with proper use. Nevertheless,
the biomedical engineer can adjust the output of the LED using a potentiometer located at the

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rear base of the light box. The LED is expected to operate on high intensity (≥30 µW/cm2/nm)
approximately 20,000 hours. Actual results will vary based on environmental factors and
adjustments to the potentiometer. Due to the nature of the LED light source, this device does
not require a pre-ageing period prior to initial use. It also does not require a stabilization
(burn-in) period prior to each use.
The neoBLUE blanket system comes with a large or small size fiberoptic blanket. The life
expectancy of the fiberoptic blanket will vary with use conditions and adjustments to the
potentiometer.
Pole-Mounting Hardware (optional)
Optional hardware is available for pole-mounting applications. The neoBLUE blanket pole-
mounting hardware is designed to attach to poles with 0.75 to 1.5 inch (1.91 to 3.81 cm)
diameters.
1.5.Power Requirement Information
The neoBLUE blanket device can be directly connected to nominal voltages readily available
throughout the world as the external power supply provided with this device is rated for use
with 100-240 Volts at either 50 or 60 Hz. This external power supply provides 12 VDC to the
light box and plugs in to a receptacle at the rear of the light box.
1.6.Contraindications
Congenital porphyria or a family history of porphyria is an absolute contraindication to the use
of phototherapy, as is the concomitant use of drugs or agents that are photosensitizers. ²
Do not use the light box or fiberoptic blanket in or near high strength magnetic fields (for
example, in or near MRI machines). This product is considered to be “MR Unsafe”.
2. Safety Information
2.1. Explanation of Terminology
This manual presents two types of precautionary information. The Warning and Caution
statements are both important to the safe and effective use of the light. Each statement is
categorized by using an introductory word in boldface as follows:
Warning! A statement which describes serious adverse reactions and potential safety
hazards, limitations in use imposed by them, and steps that should be taken if they occur.
Caution: A statement which includes information regarding any special care to be
exercised by the practitioner, user, and/or patient for the safe and effective use of the device.
Note: Background information provided to clarify a particular step or procedure.
2.2.General Safety Information
Before administering phototherapy, read all sections of this manual carefully. Observe all
precautions to ensure the safety of the patient and those near the instrument. In addition,
please refer to your hospital policy and procedure for phototherapy administration.
Note: Refer to the jaundice management guidelines or regulations in your country to
determine best treatment path for neonatal hyperbilirubinemia; such as the AAP Guidelines
(American Academy of Pediatrics Clinical Practice Guideline –Management of
Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation); or NICE guidelines
(National Institute for Health and Clinical Excellence –Neonatal Jaundice).

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Note: Any serious incident that has occurred in relation to the device should be reported, to
the manufacturer and the competent authority of the Member State in which the user and/or
patient is established.
2.3.Safety Symbols
Be aware of the following symbols, which appear on the device/accessories.
Symbol
Meaning
Refer to instruction manual
Consult Instructions for Use
Caution
Warning
Type BF patient-applied part
On (power on)
Standby (power off)
IPX3
Protected against spraying water
IP21
Protected from condensation
Protected against insertion of fingers or become unsafe during
dripping water
Protect the patient's eyes with eye patches or equivalent
Single-use only
Operating conditions
DC Voltage

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Symbol
Meaning
Authorized European Representative
Manufacture Date
Manufacturer
Double-insulated (Class II)
Prescription use only
Do not use in MRI Environments
Waste Electrical and Electronic Equipment (WEEE)
Medical
Device
Indication that device is a Medical Device
WEEE Statement
Natus is committed to meeting the requirements of the European Union WEEE (Waste Electrical and
Electronic Equipment) Regulations 2014. These regulations state that electrical and electronic waste
must be separately collected for the proper treatment and recovery to ensure that WEEE is reused or
recycled safely. In line with that commitment Natus may pass along the obligation for take back and
recycling to the end user, unless other arrangements have been made. Please contact us for details on
the collection and recovery systems available to you in your region at www.natus.com.
Electrical and electronic equipment (EEE) contains materials, components and substances that may be
hazardous and present a risk to human health and the environment when WEEE is not handled correctly.
Therefore, end users also have a role to play in ensuring that WEEE is reused and recycled safely. Users
of electrical and electronic equipment must not discard WEEE together with other wastes. Users must use
the municipal collection schemes or the producer/importers take-back obligation or licensed waste
carriers to reduce adverse environmental impacts in connection with disposal of waste electrical and
electronic equipment and to increase opportunities for reuse, recycling and recovery of waste electrical
and electronic equipment.
Equipment marked with the crossed-out wheeled bin (WEEE symbol above) is electrical and electronic
equipment. The crossed-out wheeled bin symbol indicates that waste electrical and electronic equipment
should not be discarded together with unseparated waste but must be collected separately.

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Warning!
Risk of injury to the patient under phototherapy treatment:
➢Intensive phototherapy (≥30 µW/cm2/nm), may not be appropriate for all neonates (i.e.
preterm neonates ≤1000g). ¹
➢Duration of the treatment must be prescribed by the physician for each patient.
➢Monitor all patients during intensive phototherapy treatment as directed by physician.
•Measure the patient’s bilirubin level periodically.
Note: Turn the unit off when checking the patient’s condition and visualizing
skin color; blue light can hinder clinical observations by masking skin color
changes, such as cyanosis.
•Monitor patient temperature and fluid status.
•Periodically verify that the patient’s eyes are protected and free of infection.
➢To avoid eye-damage during phototherapy treatment, protect the patient’s eyes with
appropriate size eye protection.
Note: Refer to the instruction that comes with the eye protector for proper fit.
➢Bilirubin photoisomers may cause toxic effects.
➢To avoid any entanglement, always place the patient on the blanket mattress with
their head opposite the end where the fiberoptic cable is attached.
➢Incorrect use of the device, or the use of parts and accessories that are not
manufactured or supplied by Natus Medical Incorporated, can damage the light, and
may cause injury to the patient and/or user.
➢Do not use without blanket mattress and disposable blanket cover (intended for
single-use only). The device must be used with the supplied Natus blanket mattress
and cover in place to ensure proper treatment uniformity.
➢Do not use reflective foils to increase the effectiveness of phototherapy treatment; it
may affect the patient’s body temperature.
➢In order to ensure proper dosage is delivered to the patient, it is recommended to
measure the intensity before each use with a radiometer. Not measuring may lead to
providing less intensity than the dose prescribed by the physician.
➢Follow physician instructions when using neoBLUE blanket system in conjunction with
an overhead neoBLUE light or other intensive phototherapy systems.
_________________________________________________________________
Warning!
Risk of injury to the other patients or the operator:
➢Do not look directly into the emitted light from the light box. Light output from the light
box is intense and could lead to eye-damage.
➢Do not use the device if any parts appear damaged or if there is any reason to believe
that it is not functioning properly. Contact Natus Medical Incorporated Technical
Service or your authorized service provider.

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➢Light sensitive individuals may experience headache, nausea or mild vertigo if he/she
stays too long in the illuminated area. Using the neoBLUE blanket device in a well-
lighted area or wearing glasses with yellow lenses can alleviate potential effects.
➢The unit should be turned off when patient is not on the blanket mattress or when the
caregiver is attending to the patient.
➢To avoid overheating the light box, check that the air vents are not covered with
blankets, clothing, dust and lint, or positioned against obstructing surfaces.
➢When attaching the light box with the optional pole-mounting hardware to any pole or
roll stand, confirm the weight capacity and stability of the overall assembly before
using.
__________________________________________________________________
Warning!
Risk of injury when using the device with other devices:
➢The light box is not designed to be used in an oxygen-enriched environment such as
an incubator.
Note: It is acceptable to use the fiberoptic blanket mattress within an incubator with
the light box positioned outside the incubator.
➢Do not use the light box in the presence of gases that support combustion (for
example, oxygen, nitrous oxide, or other anesthetic agents).
Note: It is acceptable to use the fiberoptic blanket mattress in the presence of
combustible gases.
➢Do not use the light box or fiberoptic blanket in or near high strength magnetic fields
(for example, in or near MRI machines). This product is considered to be “MR
Unsafe”.
➢This system may cause radio interference or may disrupt the operation of nearby
equipment. It may be necessary to take mitigation measures, such as reorienting or
relocating the device or shielding the location.
➢Device is suitable for hospital and home environment except for near active HF
surgical equipment and the RF shielded room of an ME system for magnetic
resonance imaging, where the intensity of EM disturbance is high
➢Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this equipment
and the other equipment should be observed to verify that they are operating
normally.”
➢Use of accessories, transducers and cables other than those specified or provided by
the manufacturer of this equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this equipment and result in
improper operation
➢Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to
any part of the neoBLUE blanket, including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment could result.

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_________________________________________________________________
Caution:
➢When the over-temperature indicator light double blinks, the fiberoptic blanket is at the
end of its useful life and needs to be replaced.
➢Do not use the light box under a radiant warmer.
Note: When the light box is placed directly under radiant heat source, it can damage
the light box and possibly trigger the over-temperature indicator light which may cause
the blue treatment light to turn off.
➢The light generated can degrade photosensitive medications. Do not place or store
any drugs near or in the illuminated area.
➢Never place flammable objects on the light box.
➢When inserting or removing the fiberoptic cable from the light box, hold the light box
with one hand to secure and prevent from moving.
➢The use of power supply, cables or accessories other than the ones supplied by
Natus Medical Incorporated is not recommended and could result in poor performance
and change the EMC performance with respect to emissions and immunity of this
product. Only use with cables and accessories provided by Natus Medical
incorporated.
➢Only qualified personnel should perform service and repair of the light box and LED.
Consult Natus Medical Incorporated for repair and replacement.
➢The neoBLUE blanket device is a Class B device (CISPR 11 Classification), which is
allowed in domestic establishments when used under the jurisdiction of a health care
professional.
➢Degradation of the performance of this equipment could result if precautions not taken
regarding EMC environment and RF communications equipment. See Service manual
Appendix B for details
➢Do not clean the light box, blanket or mattress with caustic or abrasive cleaners,
alcohol, acetone, or other solvents. Always switch off the power and disconnect the
power cord from the light box when cleaning the device.
➢While the light box is splash resistant to IP21 and blanket pad is protected against
spraying water to IPX3 requirements per standard IEC60529, avoid spraying liquids
directly onto the light box, and do not allow them to seep into the interior.
➢Varying environmental conditions, may adversely affect the performance of this
equipment. Please be aware the operating temperature and humidity for the neoBLUE
blanket light box is 41°- 86° F (5°- 30° C) / 10% - 90% non-condensing; and the
operating altitude and atmospheric pressure is 700 hPa to 1060 hPa (about -1,000 to
+10,000 feet).

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3. Components and User Controls
3.1. neoBLUE blanket LED Phototherapy System
3.2.Light Box

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3.3.Fiberoptic Blanket
3.4 Controls
On/Standby Switch: Use this switch to turn the unit ON ( |) or place in STANDBY ( ). The
switch is located on the top of the light box. The green indicator light located on the switch,
when lit, indicates the unit is ON. The unit will not emit the blue phototherapy treatment light
until the switch is ON and a fiberoptic cable is fully inserted into the fiberoptic coupling in the
light box.
Power Cord Attachment: The power cord attachment is at the rear of the light box.
Vents: There are vents located at the sides of the light box. A ventilating fan prevents the LED
from overheating.
Over-Temperature Indicator Light: The Over Temperature Indicator Light located next to the
switch at the rear of the light box can indicate two different temperature related conditions with
the light box. One indication is for a condition when the temperature inside the light box,
especially the therapy LED, is getting too warm. In this case, the amber indicator light will
blink ON and OFF and the blue treatment light will automatically turn Off to reduce the
temperature while the fan will continue to run. Should this happen, the vents should be
checked to ensure they are not blocked. When the unit has cooled down sufficiently, the blue
treatment light will turn back on automatically. The amber indicator light will continue blinking
to indicate that an overheating situation has occurred. This amber indicator light can be reset
by toggling the On/Standby switch to Standby and then back On.
A second condition is if the lens interface overheats. In that event, the amber indicator light
will double-blink, however, the blue treatment light will continue operating. In the event that
the interface continues to heat and reaches a cut-off temperature, the amber indicator light will
continue to double-blink but the blue therapy light will turn Off. The blue therapy light and the
amber indicator light can be reset by toggling the On/Standby switch to Standby and back On
once the light box has sufficiently cooled down.
Warning! To avoid overheating the light box, check that the air vents are not covered
with blankets, clothing, dust and lint, or positioned against obstructing surfaces.
Caution: When the over-temperature indicator light double blinks, the fiberoptic blanket
is at the end of its useful life and needs to be replaced.
Coupler tip
Fiberoptic
cable

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Timer: The neoBLUE blanket is equipped with a timer to track the total number of hours the
blue therapy light is switched on. The timer will count up to a maximum of 9999999.9 hours.
The decimal point will be flashing at a steady rate when the timer is counting. When the timer
is not counting, the decimal point will not flash. The timer will count any time that light is
emitted from the light box. The last digit refers to tenths of hours, with 0.1 = 6 minutes.
3.5 Pole-Mounting Hardware (optional)
The neoBLUE blanket Light Box can be mounted to poles (such as the pole attachment
accessory on incubators and patient warmers) by using the optional pole-mounting hardware.
This hardware is designed to clamp to poles with 0.75 to 1.5 inch (1.91 to 3.81 cm) diameters.
Warning! When attaching the light box with the optional pole-mounting hardware to any
pole or roll stand, confirm the weight capacity and stability of the overall assembly before using.

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4. Assembly and Operating Instructions
4.1.Preparing the neoBLUE blanket LED Phototherapy System for use:
1. Position fiberoptic blanket with mattress in a bassinet, open bed, radiant warmer, or
incubator.
2. Position light box and insert fiberoptic cable into the fiberoptic coupling.
Note: If using an incubator, position fiberoptic cable through one of the incubator ports then
insert into light box located outside the incubator.
Note: Place the light box away from patient, on a flat, stable, surface, free from obstruction
and clutter, or mount to a pole using optional hardware.
Warning! When attaching the light box with the optional pole-mounting hardware to any
pole or roll stand, confirm the weight capacity and stability of the overall assembly before using.
Warning! To avoid overheating the light box, check that the air vents are not covered with
blankets, clothing, dust and lint, or positioned against obstructing surfaces.
Caution: When inserting or removing the fiberoptic cable from the light box hold the light
box with one hand to secure and prevent from moving.
3. Connect power supply to suitable wall outlet and to light box. Power supply cords should
be safely routed.
4. Apply disposable cover,by slipping over the blanket mattress. Replacement covers are
consumable products to be discarded after single-use (replacement covers can be
ordered from Natus Medical Incorporated).
Warning! Do not use without blanket mattress and disposable blanket cover (intended
for single-use only). The device must be used with the supplied Natus mattress and cover in
place to ensure proper treatment uniformity.
Note: The mattress comes already installed over fiberoptic blanket. The mattress is semi-
durable (replacement mattresses can be ordered from Natus Medical Incorporated).
5. Switch on power, by moving the power switch to the ON ( | ) position.
6. Check intensity of the light using a radiometer per your institution’s procedures. Refer to
Section 6.1, “Checking the Light Intensity.”The light intensity output of the neoBLUE
blanket system was factory set to 35 ±5 μW/cm2/nm using a neoBLUE Radiometer.
4.2.Administering phototherapy treatment:
Warning! Intensive phototherapy (≥30 µW/cm2/nm), may not be appropriate for all
patients (i.e. preterm patients ≤1000g).¹
Warning! Duration of the treatment must be prescribed by the physician for each
patient.

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Warning! In order to ensure proper dosage is delivered to the patient, it is
recommended to measure the intensity before each use with a radiometer. Not measuring
may lead to providing less intensity than the dose prescribed by the physician.
7. Shield patient’s eyes with protective eye shields prior to initiating phototherapy.
Natus suggests using:
Biliband® Eye Protectors
Sizes: Micro (P/N 900644)
Premature (P/N 900643)
Regular (P/N 900642)
Warning! To avoid eye-damage during phototherapy treatment, protect the patient’s
eyes with appropriate size eye protection.
Note: Refer to the instruction that comes with the eye protector for proper fit.
Note: During periods when the patient is being held and positioned so that their eyes cannot
be exposed to the light, protective eye shields can be removed.
8. Place patient on top of neoBLUE blanket covered mattress.
Warning! To avoid any entanglement, always place the patient on the blanket mattress
with their head opposite the end where the fiberoptic cable is attached.
9. Monitor patient during treatment.
Warning! Monitor all patients during intensive phototherapy treatment as directed by
physician.
•Measure the patient’s bilirubin level periodically.
Note: Turn the unit off when checking the patient’s condition and visualizing
skin color; blue light can hinder clinical observations by masking skin color
changes, such as cyanosis.
•Monitor patient temperature and fluid status.
•Periodically verify that the patient’s eyes are protected and free of infection.

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Warning! Light sensitive individuals may experience headache, nausea, or mild vertigo
if they stay too long in the illuminated area. Using the neoBLUE blanket device in a well-
lighted area or wearing glasses with yellow lenses can alleviate potential effects.
Warning! The unit should be turned off when patient is not on the mattress or as
necessary when the caregiver is attending to the patient.
10. When finished, switch power to stand-by and remove light from therapy area.
5. Troubleshooting Guide
Note: Service Manual available separately on CD. In the USA, contact Natus Technical
Service at [phone] or [phone], or E-mail: technical_serv[email protected].
Outside of the USA, contact your local distributor.
Caution: Only qualified personnel should perform service and repair of the light box and
LED. Consult Natus Medical Incorporated for repair and replacement.
Problem
Probable Cause
Action
The unit does not turn
on, fan is off.
No power
Defective switch
Defective power supply
•Verify that unit is plugged in.
•Verify that the plug into the device is
making good contact and is secure.
•Have a qualified technician check the
components and replace as
necessary.
The blue light does not
turn on, but fan is on.
Fiberoptic cable is not
attached to light box.
Circuit board is damaged
•Insert fiberoptic cable into fiberoptic
coupling in light box.
•Contact Natus Technical Service or
authorized service provider if problem
persists.
The blue light turns on,
but fan is off.
Defective fan
Defective wiring
•Contact Natus Technical Service or
authorized service provider if problem
persists.
Amber indicator light is
blinking (single blink
pattern). Blue light may
be on or off.
Device LED has overheated,
caused by:
Blocked vents,
Device being used in
operating temperature above
30ºC or
Circuit board is damaged
Fan failure
•Remove any material that may be
blocking airflow through the vents.
•Use the device in a cooler
environment.
•Contact Natus Technical Service or
authorized service provider if problem
persists.
Amber indicator light is
blinking (double blink
pattern). Blue light may
be on or off.
Internal lens interface has
overheated, caused by:
Fiberoptic pad is damaged at
coupler tip and is at the end
of its useful life
•Replace fiberoptic pad.
•Contact Natus Technical Service or
authorized service provider if problem
persists.

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6. Routine Cleaning and Maintenance
6.1.Checking the Light Intensity
It is recommended that the intensity of the light be checked before each use, to ensure the
light is providing the intended dose of treatment as prescribed by the physician. This
measurement is taken near the center of the effective treatment area on top of the mattress
and disposable cover.
neoBLUE Radiometer
Natus recommends using a properly calibrated neoBLUE Radiometer for measuring the
intensity of the neoBLUE blanket light. If this meter is not available, it is important to measure
the intensity with a radiometer specifically designed to measure the narrow wavelength
spectrum of blue LEDs. Radiometers designed to measure the broadband spectrum found in
fluorescent or halogen lights will result in inaccurate intensity measurements.
If the intensity measured falls below factory setting or hospital minimum have a qualified
technician test the intensity level and readjust the intensity to achieve the desired output, if
required.
Note: The light intensity output of the neoBLUE blanket system was factory set to 35 ±5
μW/cm2/nm using a neoBLUE Radiometer.
6.2.Adjusting the Light Intensity
The light output can be adjusted using a potentiometer located at the rear base of the light
box. Please refer to the Service Manual for instructions on how to adjust the light output.
Caution: Only qualified personnel should perform service and repair of the light box
and LED. Consult Natus Medical Incorporated for repair and replacement.
If the desired intensity output cannot be attained after several adjustments of the
potentiometer, contact Natus Technical Service or authorized service provider.
6.3.Cleaning
Caution: While the light box is splash resistant to IP21 and blanket pad is protected
against spraying water to IPX3 requirements per standard IEC60529, avoid spraying liquids
directly onto the light box, and do not allow them to seep into the interior.
Caution: Do not clean the light box, blanket or mattress with caustic or abrasive
cleaners, alcohol, acetone, or other solvents. Always switch off the power and disconnect the
power cord from the light box when cleaning the device.

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Using a soft cloth dampened with a mild detergent solution or with soap-and-water, wipe the
exterior of the neoBLUE blanket, including the light box, fiberoptic blanket / cable, mattress
and power cord. Cleaning the neoBLUE blanket device and mattress may also be
accomplished with standard hospital disinfectants.
Note: The following hospital disinfectants are safe to use on this product
(Cavicide/CaviWipes, PDI Sani-Cloth wipes, Clorox Germicidal wipes, Sporicidin, 5%
bleach).

neoBLUE® blanket LED Phototherapy System User Manual 20
PN 029142 Rev A
7. Technical Reference
The following graph shows the spectral irradiance for bilirubin of the neoBLUE blanket LED
Phototherapy System; and the peak absorption wavelength of bilirubin (458 nm). ³
The intensity of the light is factory set to 35 ±5 µW/cm2/nm at the patient surface. This
measurement is taken with a radiometer near the center of the effective surface area for
phototherapy. The following graph shows the nominal response characteristics of the
neoBLUE Radiometer, which corresponds to the peak absorption spectrum of bilirubin.
Note: During the life of the fiberoptic pad the intensity readings can vary from the factory
setting up to 10%. Please refer to the Service Manual for instructions on how to adjust the
light output.
Natus recommends using the neoBLUE Radiometer for measuring the intensity of the
neoBLUE LED Phototherapy System. If this meter is not available, it is important to measure
the intensity with a radiometer specifically designed to measure the narrow wavelength
spectrum of blue LEDs. Radiometers designed to measure the broadband spectrum found in
fluorescent or halogen lights will result in inaccurate intensity measurements.