neoBLUE LED Phototherapy System User Manual Rev C

Natus is a registered trademark of Natus Medical Incorporated © 2008 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 Incorporated. 1501 Industrial Road San Carlos, CA USA 94070 Telephone +1(650) 802-0400 Fax +1(650) 802-0401 Technical Service +1(888)-496-2887 E-mail: [email protected] www.natus.com. EU Representative Fischer-Zoth Diagnosesysteme, GmbH Walter-Kolbenhoff Str. 34 D-82110 Germering Germany Phone: +49 (89) 89 45 97 3 Fax: +49 (89) 89 45 97 59

neoBLUE® LED Phototherapy System User Manual PN 001364 Rev. C

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Contents 1 Product Description ... 1 2 Safety Information ... 4 2.1 Explanation of Terminology ...4 2.2 General Safety Information ...4

3 Components and User Controls... 7 3.1 Light Enclosure and Roll Stand...7 3.2 Front Panel Controls ...8 3.3 Rear Panel ...8

4 Assembly and Operating Instructions…………………………………………………..10 5 Troubleshooting Guide ... 12 6 Routine Cleaning & Maintenance ... 13 6.1 Checking the Light Intensity...13 6.2 Cleaning ...13

7 Technical Reference ... 15 8 Specifications ... 17 9 Index………………………………………………………………………………………………….18

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Product Description The neoBLUE® Phototherapy System consists of two products – the neoBLUE LED Phototherapy light source (light) and the neoBLUE LED Phototherapy roll stand. Intended Use The neoBLUE LED Phototherapy System is intended for the treatment of neonatal hyperbilirubinemia. The light can be used for infants in a bassinet, incubator, open bed, or radiant warmer. Important! Before assembling the neoBLUE light and administering phototherapy, read all sections of this manual carefully. There are safety considerations that should be read and understood before use.

Physical Characteristics The neoBLUE LED Phototherapy System is a floor-standing, mobile phototherapy light that delivers a narrow band of high-intensity blue light via blue light emitting diodes (LEDs) to provide treatment for neonatal hyperbilirubinemia.

Light Source The light consists of a lightweight plastic light enclosure. When used with the neoBLUE roll stand, the light can be tilted and adjusted both horizontally and vertically on the roll stand assembly. The light enclosure can be tilted to approximately 40° up from horizontal (the resting position). The light enclosure height can be adjusted vertically along the roll stand post, as well as horizontally out from the roll stand post (proximity adjustment) to aid in positioning the light. To help position the light over the infant, a red target light can be briefly illuminated using the right rocker switch on the front panel. The light can be used for infants in a bassinet, incubator, open bed, or radiant warmer. The light can be used independently of the roll stand. The light enclosure can be placed directly on an incubator with a flat-topped surface. Warning! Placement directly on incubator: The enclosure can be placed on flat surfaces only. Confirm all rubber feet are fully seated on the top of the enclosure to prevent slippage. When placing light enclosure directly on incubator, care must be taken to ensure a safe operating environment. Secure power cord to minimize risk of tripping. Warning! Placement directly on incubator: The use of skin-controlled mode (patient servo) of the incubator or radiant warmer is recommended unless manual mode (air servo) is specifically prescribed. While both modes require patient monitoring, manual mode requires constant attention. In manual mode, care must be taken to observe any changes in ambient conditions (drafts, sunlight, phototherapy light usage, etc) as small changes can have an effect on patient temperature. While patient servo also requires attention, the radiant warmer is designed to keep the patient’s skin temperature controlled, reducing (but not eliminating) the need to monitor the patient. In addition, use of reflective foils may cause hazardous body neoBLUE® LED Phototherapy System User Manual PN 001364 Rev. C

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temperatures. Monitor the infant’s skin temperature per your hospital policy during phototherapy to avoid fluctuations in body temperature. Warning! Use with Radiant Warmer: Do not place the neoBLUE light directly under radiant heat source. There are two intensity settings, high and low. The desired setting is selected using the left rocker switch on the front panel of the light. The light output is optimized to provide a peak intensity of > 30 µW/cm2/nm at the high setting and > 12 µW/cm2/nm at the low setting at 30.5 cm (12 inch) distance from the light enclosure. A lens panel protects the light from incidental debris or fluid exposure. 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 energy in the ultraviolet (UV) region of the spectrum, so there is no UV exposure to the infant. In addition, blue LEDs do not emit energy in the infrared (IR) region of the spectrum, minimizing concern about 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 two potentiometers located on the side of the light enclosure. The light is expected to operate at the specified intensities approximately 10,000 hours at the low setting, and approximately 4,000 hours at the high setting.

Timer The neoBLUE light is equipped with a timer to track the total number of hours it is switched on. The timer will count up to a maximum of 99999.9 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 the lighted green on/standby switch is in the on position. The timer will count at the same rate regardless of the intensity setting at which the device is being used. The last digit refers to tenths of hours, with 0.1 = 6 minutes. To reset the timer, please refer to the service manual.

Phototherapy Roll Stand The roll stand is designed to hold the neoBLUE light with a base designed to accommodate the weight distribution of the light enclosure at any height or angle. Warning! If an alternative stand is used, care must be taken to validate the load capacity. See Regulatory/Safety Standards (Section 8). Caution: Use care when repositioning the roll stand around other equipment to prevent accidental change or damage to surrounding equipment.

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The roll stand operates on a gas shock to maintain a safe pole height during adjustments. The roll stand incorporates features to adjust the height, tilt and proximity of the light source as described in Section 3.1.

Power Requirement and Accessories The light is mains-power operated. The power cord plugs into a receptacle at the power inlet at the back of the light enclosure. There are no single-use components for the light. A power cord strain relief bracket is provided to hold the power cord in place. Lighted Green On/Stand-by Switch The lighted green switch (between the target light switch and the intensity switch) is used to turn the device on or put it in stand-by mode. The switch should only be illuminated when in the on position. When in the stand-by position, line voltages are still present inside the device if the device is plugged in, but no DC voltage is being switched to the LED panel, fans or timer.

Accessory Pack An accessory pack is included with each light enclosure. The accessory pack contains the following items: a CD, a power cord, a power cord strain relief bracket to hold the power cord in place, vent filters and extra thumb screws and mounting posts for attaching the light enclosure to the roll stand.

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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 Incorporated, 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. The neoBLUE light is a Class A device (CISPR Classification), which is allowed in domestic establishments when used under the jurisdiction of a health care professional. This light may cause radio interference, in which case adequate measures may be required to prevent interference. Warning! Placement directly on incubator: The enclosure can be placed on flat surfaces only. Confirm all rubber feet are fully seated on the top of the enclosure to prevent slippage. When placing light enclosure directly on incubator, care must be taken to ensure a safe operating environment. Secure power cord to minimize risk of tripping. neoBLUE® LED Phototherapy System User Manual PN 001364 Rev. C

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Warning! Placement directly on incubator: The use of skin-controlled mode (patient servo) of the incubator or radiant warmer is recommended unless manual mode (air servo) specifically prescribed. While both modes require patient monitoring, manual mode requires constant attention. In manual mode, care must be taken to observe any changes in ambient conditions (drafts, sunlight, phototherapy light usage, etc) as small changes can have an effect on patient temperature. While patient servo also requires attention, the radiant warmer is designed to keep the patient’s skin temperature controlled, reducing (but not eliminating) the need to monitor the patient. 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! Use with Radiant Warmer: Do not place the neoBLUE light directly under radiant heat source. Warning! Attachment of Light Enclosure: When attaching the light to any floor stand other than the neoBLUE roll stand, confirm weight capacity of stand. Tippage test must be done with the light in the fully extended position to conform to Regulatory/Safety Standards noted in Specifications (Section 8). 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 light may impact the heat supply in thermotherapy devices (incubators, radiant warmers, or heated mattresses) and the patient’s body temperature. 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 irradiated area. Using the neoBLUE system in a well-lighted area or wearing glasses with yellow lenses can alleviate potential effects. The neoBLUE light drapes may be used and are available through Natus Medical, Inc. (P/N 001241) or Wrapped in Comfort (www.wrappedincomfort.com). Caution: To avoid overheating, do not cover vents by drapes. Guard Dog Bones glasses (P/N 413BB) are recommended and are available online at www.safetyglasses.com or www.safetyglassesusa.com. neoBLUE® LED Phototherapy System User Manual PN 001364 Rev. C

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Warning! Photoisomers: Bilirubin Photoisomers may cause toxic effects. Warning! Lens: Do not use the light if the lens is missing or damaged. The lens is a plastic shield that protects the baby 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. Important! The light was factory calibrated to deliver intensive phototherapy at a distance of 30.5 cm (12 inches) from the baby. Refer to the service manual for information on adjusting the intensity if using the light at other distances. Caution: Other equipment: Do not attach other equipment not supplied by Natus Medical Inc. and indicated for use with the light to the neoBLUE system, or place anything on top of the light. The roll stand and light are not designed to support additional equipment.

Safety Symbols Warning! Be aware of the following symbols, which appear on the light and/or the roll stand. Symbol

Meaning Type BF rated for patient-applied parts On Stand-by Attention, consult product documentation Always protect the baby's eyes with eye patches or equivalent

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Components and User Controls

3.1 Light Enclosure and Roll Stand The neoBLUE LED 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 on either side and torquing to desired angle. Use an allen wrench to adjust the tension of the roll stand/enclosure attachment to facilitate positioning. To remove the light from the roll stand, loosen the top two thumb screws and lift the enclosure up and away from the roll stand. Lens: The lens is a plastic shield that protects the baby and the unit from incidental debris or fluids. Height Adjustment: This knob allows you to adjust the height of the light enclosure. First loosen the knob, then adjust the height of the light enclosure, and finally tighten the knob to lock the height. Proximity Adjustment: This knob allows you to adjust the distance between the light enclosure and the roll stand post. To adjust, loosen the knob, adjust the position of the light enclosure, and then tighten the knob once the desired distance is achieved. Locking Casters (two): Once the light is in place for phototherapy, these casters should be locked to prevent the light from rolling around freely. Casters lock and unlock with slight foot pressure on the locking ring. neoBLUE® LED Phototherapy System User Manual PN 001364 Rev. C

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Roll Stand Base: The low profile circular base is designed to prevent tipping when the light is at any angle or distance from roll stand. Base fits under standard incubators to allow easy placement.

3.2 Front Panel Controls

Front Panel Controls

Irradiance Level Control: Use this switch to select between two intensity settings. Low (Ζ) / High (ΖΖ) On/Stand-by Switch: Use this switch to turn the main power ON ( | ) or to Stand-by ( ). The switch is located in the front of the light enclosure between the irradiance level control and target illuminate switch. Target Illumination Switch: To help center the light over the infant, press this switch to project a red light over the centrally illuminated area.

3.3

Rear Panel Power cord attachment

Timer

Fan inlet vents with filters

Passive air conduction vents (along bottom sides, front, and back edges)

Timer: The neoBLUE light is equipped with a timer to track the total number of hours it is switched on. The timer will count up to a maximum of 99999.9 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 neoBLUE® LED Phototherapy System User Manual PN 001364 Rev. C

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the lighted green on/standby switch is in the on position. The timer will count at the same rate regardless of the intensity setting at which the device is being used. The last digit refers to tenths of hours, with 0.1 = 6 minutes. To reset the timer, please refer to the service manual. Vents: There are two fan inlet vents at the back of the light enclosure. The ventilation fans prevent the unit from overheating. The inflow vents have filters that should be cleaned on a regular basis (see section 6.3 Cleaning). Along the bottom front, sides, and back edges are passive air conduction vents. If the fans cease to operate, contact Natus Technical Service or your authorized service provider. Caution: To avoid overheating the light, do not cover vents (refer to Section 6.3, “Cleaning” for more information on vents).

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Assembly and Operating Instructions Assembly The neoBLUE system consists of two products shipped in two separate boxes. One box contains the light enclosure and the other box contains the roll stand (post/attachment arm and base). To assemble the light, follow these steps: 1

Unpack the shipping boxes. Check contents against the packing lists.

2

Refer to assembly instructions enclosed in the roll stand box.

Operating Instructions 1

Check intensity. Check the intensity of the light using a radiometer per your institution’s procedures (see Section 6.1, “Checking the Light Intensity”). The light provides an intensity of 12-15 µW/cm2/nm at the Low setting and > 30 µW/cm2/nm at the High setting at a 30.5 cm (12 inch) distance from the baby.

2

Prepare infant. Infant may lie in an open crib, a bassinet, an incubator, or under a radiant warmer. Warning! Select only infants for whom phototherapy has been prescribed.

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Shield infant’s eyes with protective eye shields designed for use during phototherapy. Biliband® Eye Protectors Sizes: Micro (P/N 900644) Premature (P/N 900643) Regular (P/N 900642) 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.

4

Position light over infant. Important! The light was factory calibrated to deliver intensive phototherapy at a distance of 30.5 cm (12 inches) from the baby. Refer to the service manual for information on adjusting the intensity if using the light at other distances.

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Switch on power, using the power switch in the front of the light enclosure. Warning! Operator Safety: Sensitive individuals may experience headache, nausea or mild vertigo if he/she stays too long in the irradiated area. Using the neoBLUE system in a well-lighted area or

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wearing glasses with yellow lenses can alleviate potential effects. The neoBLUE light drapes may be used and are available through Natus (P/N 001241) or Wrapped in Comfort (www.wrappedincomfort.com). Caution: To avoid overheating, do not cover vents by drapes Guard Dog Bones glasses (P/N 413BB) are recommended, and are available online at www.safetyglasses.com or www.safetyglassesusa.com. 6

Press the target light switch to center the light over the infant. Tilt or position the light enclosure as desired. Important! The light was factory calibrated to deliver intensive phototherapy at a distance of 30.5 cm (12 inches) from the baby. Refer to the service manual for information on adjusting the intensity if using the light at other distances.

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Select High or Low intensity setting, as appropriate for the patient.

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Monitor the patient during treatment. Warning! Regular monitoring during treatment is recommended. Use the following guidelines:

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•

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 visualizing 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.

When finished, switch power to stand-by and remove light from the therapy area.

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Troubleshooting Guide Note: neoBLUE device Service Manual available separately. In the USA, contact Natus Technical Service at +1 (888)-496-2887 or E-mail: [email protected]. 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. Problem

Probable Cause

Action

The unit does not turn on; fan is off.

No power

• Verify that unit is plugged in.

Defective switch

• Check fuses in the fuse box.

Defective power supply

• Have a qualified technician check the components and replace as necessary.

One LED may have burned out, causing six LEDs to go off

• Have a qualified technician test the intensity level and readjust the intensity potentiometers to achieve the desired output, if required.

Some LEDs are not lit.

The light turns on but the Defective fan fan is off. Defective wiring Fan is jammed due to debris

• Clean fan (Refer to Section 6.3) • Contact Natus Technical Service or authorized service provider if problem persists.

Target light switch does Defective circuitry not work.

• Contact Natus Technical Service or authorized service provider.

The unit will not move Casters are locked around on the neoBLUE roll stand.

• Unlock the two casters.

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Routine Cleaning and Maintenance

6.1 Checking the Light Intensity It is recommended that the intensity of the light be checked per your hospital protocol, or at least every six months to ensure proper light intensity. Have a qualified technician test the intensity level and readjust the intensity potentiometers to achieve the desired output, if required. Checking intensity before each use is recommended; however, as LEDs have very gradual degradation over time, it is not mandatory. Note: The intensity of the light is not adversely affected if a few LEDs burn out. The LEDs are installed in groups of six, so failure of a single LED normally causes six to fail. 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 below hospital-defined minimums, then the light should be readjusted. Please refer to the neoBLUE 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 neoBLUE® Radiometer to deliver a peak intensity of 30-35 µW/cm2/nm at a 30.5 cm (12 inch) distance from the baby. Please refer to Section 7 of this manual or Tech Note P/N 051124 for information on other meters.

6.3 Cleaning Warning! Disconnect the 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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Note: To ensure correct operating temperature, the vent filter on the back of the light should be kept clear and free of dust. As part of routine maintenance, the vent filters should be cleaned every month: • • • •

Remove black filter cover. Remove filter and run under water to rinse away dust. Allow filter to air dry before placing back in the vent. Place filter back in vent and snap filter cover back in place.

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Technical Reference The following graph shows the normalized spectra of the blue LEDs and the spectral sensitivity of the radiometer.

% Normalized Response/Intensity

100 Radiometer Response

80

neoBLUE Intensity

60 40 20 0 380

420

460

500

540

Wavelength (nm) Measurements for this light were made using a standard radiometer.

The peak intensity of the light is > 12 µW/cm2/nm at the Low setting and > 30 µW/cm2/nm at the High setting, at a 30.5 cm (12 inch) 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, cm (Inches)

Intensity (µW/cm2/nm) Low High

15.2 cm (6 in)

24.0

54.2

30.5 cm (12 in)

15.0

35.0

45.7 cm (18 in)

8.7

20.3

61.1 cm (24 in)

4.9

11.5

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The light intensity output of neoBLUE devices is measured at Natus prior to shipment with the neoBLUE® Radiometer. Because your facility may use a different radiometer to measure the light intensity output, it is necessary to understand how your reading may differ from the neoBLUE Radiometer reading. The following table provides a guideline on how light intensity may vary. Given variations in radiometers and light sources, this should be used as a guideline only with a tolerance of +/- 10%.

neoBLUE Light Intensity Output Chart Radiometer: (µW/cm2/nm)

neoBLUE® Radiometer

Ohmeda BiliBlanket® Meter II

Olympic Bili-Meter™

34.7

34.7

22.7

neoBLUE overhead light measured at 12 inches / 30.5 cm distance

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Specifications Light Source Wavelength

Blue and Yellow LEDs Blue: Peak between 450 and 470 nm Yellow: Peak between 585 and 595 nm

Intensity Low setting High setting

Peak intensity at 12 in (30.5 cm) > 12 µW/cm2/nm > 30 µW/cm2/nm

Variation in intensity over 6 hrs

< 10% (within illumination area)

Effective surface area

20 x 10 in (50 x 25 cm)

Intensity ratio

> 0.4 (minimum to maximum)

Heat output (at 11.8 in over 6 hrs) (at 30 cm over 6 hrs)

< 18° F (10° C) warmer than ambient

Electrical Mains

85–264 VAC, 47 to 63 Hz

Maximum Rating

3A, 100-240V~, 50/60 Hz

Fuses

4A @ 100-120V~, 50/60 Hz 2A @ 200-240V~, 50/60 Hz

Safety Leakage current

< 100 μA

Audible Noise

< 60 dB

Dimensions Maximum Height

< 6 ft (1.83 m)

Weight

< 8.0 lbs (3.6 kg) (light enclosure only) < 40 lbs (18 kg) (with roll stand)

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

Roll Stand Height of lens from ground

adjustable from 42 to 59 ± 3 inches (1.07 m to 1.50 m ± 7.6 cm)

Center of lens from post

adjustable from less than 9 to 13 ± 1 inches (22.9 cm to 33 cm ± 2.5 cm)

Tilt adjustment of enclosure

0º (horizontal) to approx. 40º

Clearance of base from floor

< 4 inches (10.2 cm)

Base

5 legs with casters (2 locking casters)

Regulatory Standards

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Type BF EN 60601-1-1, EN60601-1-2 EN60601-2-50 UL2601-1 CSA C22.2 601.1 17