natus neoBLUEmini User manual

____________________________________________________________
User Manual

neoBLUE
®
mini System User Manual P/N 051440D
ii
Caution: Federal Law (U.S.) restricts this device to sale or use by or
on the order of a physician (or properly licensed practitioner).
Natus is a registered trademark of Natus Medical Incorporated
neoBLUE mini is a trademark of Natus Medical Inc.
Biliband is a trademark of Nascor Pty, Ltd
BiliBlanket is a registered trademark of Ohmeda.
Bili-Meter is a trademark of Olympic Medical.
© 2006 Natus Medical Inc. All rights reserved.
This manual may not be reprinted or copied in whole or in part
without written consent from Natus Medical Inc. The content of this
manual may change without notice.
Natus Medical Inc.
1501 Industrial Road
San Carlos, CA 94070 USA
Telephone [phone]
Fax [phone]
Technical Service [phone]
Technical Service Fax [phone]
E-mail: [email protected]
Customer Service [phone]
Customer Service Fax [phone]
E-mail: [email protected]
International Support - Please contact your local Distributor.
Distributor locations can be found at www.natus.com
EU Representative
Fischer-Zoth Diagnosesysteme GmbH
Walter-Kolbenhoff-Str. 34
D-82110 Germering
Germany

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Contents
1 Product Description
1.1 Intended Use
1.2 Physical Characteristics
1.3 Light Source
1.4 Adjustable Arm
1.5 Power Requirements and Accessories
1.6 Accessory Pack
2 Safety Information
2.1 Explanation of Terminology
2.2 General Safety Information
2.3 Safety Symbols
3 Components and User Controls
3.1 Components
3.2 User Controls
4 Assembly and Operating Instructions
4.1 Setting Up the Device
4.2 Preparing Infant for Phototherapy
4.3 Administering Phototherapy
5 Troubleshooting Guide
6 Routine Cleaning & Maintenance
6.1 Checking the Light Intensity
6.2 Adjusting the Light Intensity
6.3 Cleaning
7 Technical Reference
8 Specifications
9 Measuring the neoBLUE mini Light with a Photometer

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1 Product Description
The neoBLUE

mini LED Phototherapy System consists of two components – the neoBLUE
mini phototherapy light source and the adjustable arm with pole mount.
1.1 Intended Use
The neoBLUE mini LED Phototherapy System is intended for the treatment of neonatal
hyperbilirubinemia. The light can be used for infants in an open bed, incubator, bassinet, or
radiant warmer.
Important! Before administering phototherapy with the neoBLUE mini light, read
all sections of this manual carefully. There are safety considerations that should be
read and understood before use.
1.2 Physical Characteristics
The neoBLUE mini device is a mobile phototherapy light that delivers a narrow band of
high-intensity blue light via light emitting diodes (LEDs) to provide treatment for neonatal
hyperbilirubinemia.
1.3 Light Source
The light is housed in a lightweight plastic enclosure. When used with the arm, the light
can be positioned in multiple positions and used with a variety of patient enclosures such as
open beds, incubators, bassinets, or radiant warmers.
The light output is optimized to provide a peak intensity of 30-35 µW/cm
2
/nm. Blue LEDs
emit light in the range of 400 – 550 nm (peak wavelength 450-470 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. Blue LEDs do not emit significant energy
in the ultraviolet (UV) or the infrared (IR) region of the spectrum, so there is no concern
about UV or IR exposure to or excessive warming of the infant. As with all phototherapy
lights, protective eyeshades must be used to protect the infant’s eyes from excessive light
exposure.
Warning! Eye Protection: Do not look directly into the LEDs. During
treatment, always protect the baby’s eyes with eye patches or equivalent.
Periodically and/or per your hospital protocol, verify that the baby’s eyes are
protected and free of infection. Patients adjacent to the light may also need to be
protected with eye patches or equivalent.
LEDs have minimal light output degradation over their lifetime with proper use.
Nevertheless, the user can adjust the output of the LEDs using the potentiometer located on
the side of the light enclosure. The light is expected to operate as specified for at least
3,000 hours.

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1.4 Adjustable Arm
The arm is designed to attach to poles with 0.75 to 1.5 inch (1.91 to 3.81 cm) diameters.
1.5 Power Requirements and Accessories
The light runs off a 12V DC power supply. The power supply is mains-power operated.
The power unit is supplied pre-attached to the pole mount portion of the arm. Grooves in
the bottom of the arm hold the power cord for safe cable management.
1.6 Accessory Pack
An accessory pack is included with each light. The accessory pack contains the following
items: a CD containing the user manual and service manual and a power cord.
2. Safety Information
2.1 Explanation of Terminology
This manual presents three types of precautionary information. The three types of
statements carry equal weight; that is, they are of equal importance to the safe and effective
use of the light. Each statement is categorized by using an introductory word in boldface as
follows:
Warning! Identifies conditions or practices that might present danger or
possible injury to the patient and/or user.
Important! An instruction provided to help ensure correct clinical results and
provide quality assurance to the phototherapy procedures.
Caution: An instruction that, if not followed, can result in a condition that could
damage the light.
Other explanatory information is highlighted with the word Note. Information in this
category is not considered precautionary.
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.
Warning! Incorrect use of the light, or the use of parts and accessories that are not
manufactured or supplied by Natus Medical Inc., can damage the light, and may cause
injury to the patient and/or user.
Do not use the light if any parts appear damaged or if there is any reason to believe that it
is not functioning properly. Contact Natus Medical Technical Service or your authorized
service provider.

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Warning! Attachment of Arm with Pole Mount: When attaching the light
to any floor standing pole, the user must validate that EN 60601-1/UL2601-1
standards for stability in normal use is met.
Warning! Attachment of Arm with Pole Mount: Ensure that the pole
mount is properly seated around the pole prior to use to prevent slippage during
use. Ensure that all screws and bolts are secure prior to use.
Warning! Weight Limitations of Arm: The arm has been validated to hold
the weight of the light enclosure only. Do not hang anything from the arm or
power cord.
Warning! Arm Adjustments: The arm folds into itself for optimal space
utilization. Use care when repositioning the arm to prevent pinching yourself.
Warning! Eye Protection: Do not look directly into the LEDs. During
treatment, always protect the baby’s eyes with eye patches or equivalent.
Periodically and/or per your hospital protocol, verify that the baby’s eyes are
protected and free of infection. Patients adjacent to the light may also need to be
protected with eye patches or equivalent.
Warning! Skin Temperature: The use of skin-controlled mode of the
incubator or radiant warmer is recommended. In addition, use of reflective foils
may cause hazardous body temperatures. Monitor the infant’s skin temperature per
your hospital policy during phototherapy to avoid fluctuations in body
temperature.
Warning ! Heat Supply: The phototherapy light may impact the heat supply
in thermotherapy devices (incubators, radiant warmers, or heated mattresses) and
the patient’s body temperature.
Warning! Use with Radiant Warmers: Do not place the phototherapy light
directly under radiant heat sources. The light should be placed up to 12 inches
(30.5 cm) from the infant, in line with the side of the heat element and angled
toward the infant.
Warning! Ambient Conditions: Varying ambient conditions, such as the
ambient temperature and/or different radiation sources, may adversely affect the
patient. Please refer to your hospital phototherapy policy and procedure regarding
appropriate ambient conditions.
Warning! Operator Safety: Sensitive individuals may experience headache,
nausea or mild vertigo if he/she stays too long in the illuminated area. Using the
neoBLUE mini device in a well-lighted area or wearing glasses with yellow lenses
can alleviate potential effects. Guard Dog Bones glasses (p/n 413BB) are
recommended and are available online at www.safetyglasses.com or via phone at 1-
800-870-6189 (US Only).
Warning! Photoisomers: Bilirubin Photoisomers may cause toxic effects.

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Warning! Clear Lens: Do not use the light if the lens is missing or
damaged. The lens is a plastic shield that provides electrical safety by protecting
the baby, operator and the unit from incidental debris or fluids.
Warning! Photosensitive Drugs: The light generated can degrade
photosensitive medications. Do not place or store any drugs near or in the
illuminated area.
Warning! Combustible Gases: Do not use the light in the presence of gases
that support combustion (for example, oxygen, nitrous oxide, or other anesthetic
agents).
Warning! Disconnect Electrical Power: Always switch off the power and
disconnect the power cord when cleaning the light.
Important! Use of Nonstandard Components: The unit uses a specific type of
LED. Consult the manufacturer for repair and replacement of LEDs. Use of
incorrect LEDs can adversely affect performance and/or damage the light.
2.3 Safety Symbols
Warning! Be aware of the following symbols, which appear on the device.
Symbol Meaning
Type BF rated for patient-applied parts
Double-insulated (Class II)
On (mains power on)
Off (stand-by)
Attention, consult product documentation

Always protect the baby's eyes with
eye patches or equivalent
Authorized European Representative
XXXX
Manufacture Date

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Natus
Manufacturer
WEEE Directive (Waste from Electrical and Electronic Equipment
Directive) Symbol – Product should not be disposed of in normal
waste

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3. Components and User Controls
3.1 Components
The neoBLUE mini phototherapy system includes the components shown in the following
figure.
Main Device Components
Light Enclosure: The light enclosure can be tilted by grasping the device and/or
gooseneck. Gross movements should be made with the arm while finer adjustments can be
made with the light enclosure and gooseneck. The light enclosure swivels around the
gooseneck to facilitate proper targeting.
Clear Lens: The lens is a plastic shield that provides electrical safety by protecting the
baby and the unit from incidental debris or fluids.
Arm: The adjustable arm allows positioning of the light in multiple locations and angles.
The arm is adjustable in five locations. A hex wrench is required. The light can be
positioned vertically by moving it up and down the pole.
Note: The optimal position for the arm is parallel to the desired light height.
Vents : There are multiple vents at the back of the light enclosure.
Caution: To avoid overheating the light, do not cover vents.
3.2 User Controls
On/Off Switch : Use this switch to turn the light ON ( |) or OFF ( ). The switch is
located on the top of the light enclosure.
Potentiometer: The potentiometer is used to adjust the light intensity as necessary.
(See Service Manual for more details)

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4. Assembly and Operating Instructions
4.1 Setting Up the Device
1. Attach the arm only to the manufacturer’s specified location on the radiant warmer or
incubator. If an open bed or bassinet is being used, attach the arm to a free-standing pole
that meets the requirements for safety listed below. Attach the power cord to the power
supply and plug into AC outlet.
Warning! Attachment of Arm with Pole Mount: When attaching the light
to any floor standing pole, the user must validate that EN 60601-1/UL2601-1
standards for stability in normal use is met.
Warning! Attachment of Arm with Pole Mount: Ensure that the pole
mount is properly seated around pole prior to use to prevent slippage during use.
Ensure that all screws and bolts are secure prior to use.
Warning! Weight Limitations of Arm: The arm has been validated to hold
the weight of the light enclosure only. Do not hang anything from the arm or
power cord.
Warning! Arm Adjustments: The arm folds into itself for optimal space
utilization. Use care when repositioning the arm to prevent pinching yourself.
2. Check intensity. Before use, check the intensity of the light using a spectrophotometer per
your institution’s procedures (see Section 6.1, “Checking the Light Intensity”). The light
has been calibrated with the Ohmeda BiliBlanket® Meter II to deliver a peak intensity of
30-35 µW/cm2/nm at a 12 inch (30.5 cm) distance from the baby. Please refer to section 9
of this manual or Tech Note, P/N 051124 for information on other meters.
4.2 Preparing Infant for Phototherapy
1. Prepare infant. The infant may lie in an open bed, incubator, bassinet, or radiant warmer.
Warning! Select only infants for whom phototherapy has been prescribed.
2. Shield infant’s eyes with protective eye shields, such as Biliband™ Eye Protectors,
designed for use during phototherapy.
Warning! Eye Protection: Do not look directly into the LEDs. During treatment,
always protect the baby’s eyes with eye patches or equivalent. Periodically and/or per
your hospital protocol, verify that the baby’s eyes are protected and free of infection.
3. Position light over infant. Position the face of the light enclosure towards the infant. The
light enclosure can be tilted by grasping the device and/or gooseneck. Gross movements
should be made with the arm while finer adjustments can be made with the light enclosure
and gooseneck. The light enclosure swivels around the gooseneck to facilitate proper
targeting.

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The adjustable arm allows positioning of the light in multiple positions. The arm is
adjustable in five locations. The light can be positioned vertically by moving it along the
pole.
The following table outlines the changes in surface area and intensity based on distance
from the light to the infant. The light has been calibrated with the Ohmeda BiliBlanket®
Meter II to deliver a peak intensity of 30-35 µW/cm2/nm at a 12 inch (30.5 cm) distance
from the baby. Please refer to section 9 of this manual or Tech Note, PN 051124 for
information on other meters.
The light intensity can be adjusted with the potentiometer during routine
service/maintenance.
Distance from Infant Peak Intensity Surface Area
8 inches (20.3 cm) 37-40 µW/cm2/nm
35 square inches (225.8 cm²) Approximately 5” x 7”
(12.7 cm x 17.8 cm)
12 inches (30.5 cm) 30-35 µW/cm2/nm 40 square inches (258.1 cm²)
Approximately 5” x 8”
(12.7 cm x 20.3 cm)
18 inches (45.7 cm) 22-25 µW/cm2/nm 48 square inches (309.7 cm²)
Approximately 6” x 8”
(15.2 cm x 20.3 cm)
4.3 Administering Phototherapy
1. Switch on power, using the power switch.
Warning! Operator Safety: Sensitive individuals may experience headache, nausea
or mild vertigo if he/she stays too long in the illuminated area. Using the neoBLUE mini
device in a well-lighted area or wearing glasses with yellow lenses can alleviate potential
effects. Guard Dog Bones glasses (p/n 413BB) are recommended and are available online
at www.safetyglasses.com or via phone at 1-800-870-6189 (US Only).
2. Monitor the patient during treatment.
Warning! Regular monitoring during treatment is recommended. Use the
following guidelines:
• Measure the patient’s bilirubin level periodically during treatment per your institution’s
procedures.
• Turn off the light when checking the baby’s condition and assessing skin color.
• Follow standard procedures for monitoring patient temperature and fluid status.
• Verify that the baby’s eyes are protected and free of infection per your institution’s
procedures.
3. When finished, switch the power off and remove the light from the therapy area.

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5. Troubleshooting Guide
Note: neoBLUE mini device Service Manual available separately. In the USA, contact
Natus Technical Service at [phone] or E-mail: [e-mail].
International Support - Please contact your local Distributor.
Distributor locations can be found at www.natus.com
Warning! Disconnect power cord before opening the light for repair .
Symptom Probable Cause Corrective Action
No power Verify that the AC outlet is functioning.
Power switch not in
correct position Ensure that the power switch is in ON (|) position
Light does
not appear when
device is turned
on Power cord not
plugged in all the
way; or is defective
Check to make sure that the power cord is
plugged in all the way to the device socket. If
the device will still not turn on try another
power cord.
Lens has become
excessively hot
(above
50°C/122°F)
Fan not working
Verify that vents are not blocked.
If the lens surface has become hotter than
50°C (122°F), verify that the fan is functioning
correctly.
Baby becomes too
warm Fan not working
Verify that vents are not blocked.
If the baby becomes too warm, verify that the
fan is functioning correctly.
Enclosure bubbles
or starts to deform Light too close to radiant heat source
Reposition the light to the side of radiant
warmer - no farther than 12 inches (30.5 cm)
from the infant.
LED string(s)
goes out LED short or open Increase the intensity if necessary.
If the device still produces enough light there
is no need to replace the panel.
Multiple LED
strings go
out; cannot attain
appropriate
intensity
Damaged LED light
panel Replace LED light panel
Arm tight
Arm loose
Check bolts, loosen as necessary
Check bolts, tighten as necessary
Light does not
hold position
Light drifts
Gooseneck has memory that may prevent it
from holding certain positions. Reposition
gooseneck or use the arm to achieve desired
location.
Optimal position for the arm is parallel to the
light height.

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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 per hospital protocol or at least
every six months.
Have a qualified technician test the intensity level and readjust the intensity
potentiometer to achieve the desired output, if required
Caution: Only qualified personnel should perform service and repair. Use extreme
care when working with exposed circuitry.
6.2 Adjusting the Light Intensity
If the intensity of light falls to less than 30 µW/cm2/nm, the light may be readjusted to
increase its intensity. Refer to the neoBLUE mini device Service Manual for more
information.
Note: The light will continue to operate with minimal degradation over time. Timing of
potentiometer adjustments is per hospital protocol.
Note: The light has been calibrated with the Ohmeda BiliBlanket® Meter II to deliver a
peak intensity of 30-35 µW/cm2/nm at a 12 inch (30.5 cm) distance from the baby. Please
refer to section 9 of this manual or Tech Note, PN 051124 for information on other meters.
6.3 Cleaning
Warning! Disconnect light from AC power before cleaning.
Remove dust from the exterior of the light with a soft brush or soft cloth dampened with
water. Sponge away remaining debris with a mild solution of detergent and water, a
noncaustic commercial cleaner, or hospital disinfectant.
Clean the lens with a soft cloth dampened with water. If water alone is ineffective in
removing fingerprints or other markings, use a mild solution of detergent and water, a
noncaustic commercial cleaner, or hospital disinfectant.
Caution: Observe the following precautions:
• Do not spray liquids directly onto the light, or allow them to seep into the interior.
• Do not use caustic or abrasive cleaners.
• Do not clean with alcohol, acetone, or other solvents.
• Never immerse the light or its component parts.

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7. Technical Reference
The following graph shows the normalized spectra of the blue LEDs and the spectral
sensitivity of the spectrophotometer.
Measurements for this light were made using a standard spectrophotometer.
The intensity of the light is set at the factory to 30-35 µW/cm2/nm at a 12 inch (30.5 cm)
distance from the light enclosure. This measurement is taken at the central area of the
effective surface area for phototherapy.
The following table shows the approximate intensity in the center of the effective surface
area with respect to distance from the light enclosure.
Distance in Inches
(cm) Intensity (µW/cm
2
/nm)
8 in (20.3 cm) 40
12 in (30.5 cm) 35
18 in (45.7 cm) 25



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8. Specifications
Light Source Blue and Yellow LEDs
Wavelength Blue: Peak between 450 and 470 nm
Yellow: Peak between 585 and 595 nm
Intensity Peak central intensity at 12 inches (30.5 cm)
30-35 µW/cm2/nm
Variation in intensity over 6 hrs < ± 10% (within illumination area)
Effective surface area at 12 in (30cm) 40 Square inches (258.1 cm²)
Approximately 8 x 5 in (20.3 cm x 12.7 cm)
Intensity ratio > 0.4 (minimum to maximum)
Heat output (at 12 in over 6 hrs) < 18° F (10° C) warmer than ambient
(at 30.5 cm over 6 hrs)
Electrical Mains 85–264 VAC, 47 to 63 Hz
Maximum Rating 0.7A, 100-240V~, 50/60 Hz
Safety
Leakage current < 100 µA
Audible Noise < 60 dB
Dimensions
Light 7.5 x 5.5 x 2 inches (19 x 14 x 5 cm) +/- 10%
Light with Arm < 6 lbs (< 2.7 kg)
Arm
Length Extends to >32 inches (>81cm)
The arm is designed to attach to poles with 0.75 to 1.5
inch (1.91 to 3.81 cm) diameters
Environmental
Operating Temperature/Humidity 59° F to 95° F (15 to 35°C) / 0% to 90% non condensing
Storage Temperature/Humidity -22° F to 122° F (-30 to 50°C) / 0% to 90% non condensing
Regulatory Standards
Type BF
EN 60601-1-1, EN60601-1-2
EN60601-2-50
UL2601-1
CSA C22.2 606.1

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9. Measuring the neoBLUE mini Light with a Photometer
This section provides important information about using photometers to measure the light
intensity output of the neoBLUE

mini LED Phototherapy device.
Natus recommends that the neoBLUE mini light intensity output be checked with a photometer per hospital
protocol or at least every six months. In addition, your photometer should be calibrated according to the
manufacturer’s specifications (typically on an annual basis). Checking intensity before each use will
confirm the “dosage” of light being delivered. In addition, by checking the intensity at the center of the
infant and at the infant’s head and feet, you can confirm proper placement of the light.
The intensity of the light source is inversely related to the distance from the source. The neoBLUE mini
LED Phototherapy System can be placed closer to the infant yielding a higher intensity or higher dosage
treatment. To adjust the neoBLUE mini light to the desired intensity when changing the distance, please
refer to the service manual.
The light intensity output of the neoBLUE mini device is measured at Natus prior to shipment with the
Ohmeda BiliBlanket® Meter II. Because your facility may use a different photometer to measure the light
intensity output, it is necessary to understand how your reading correlates to the Ohmeda reading. The
following table provides a light intensity output conversion chart, when measured at 12 inches (30 cm) from
the center of the neoBLUE mini light enclosure.
neoBLUE mini Light Intensity Output Conversion Chart
Photometer: Ohmeda BiliBlanket®
Meter II Joey Dosimeter Model JD100 Olympic Bili-Meter™
Intensity:
(µW/cm
2
/nm)
35 90.6 20.6
30 77.6 17.6
25 64.5 14.2
20 51.2 10.9
15 38.0 7.8
10 25.5 4.9
Reading Tolerance
as per manufacturer: +/- 3 % +/- 2 % +/-1.9 %
If needed, please call Natus Medical Technical Service at [phone] (US only) or your authorized
service representative.