neoBLUEcozy User Manual Rev B

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. © 2006 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 Inc. The content of this manual may change without notice. Natus Medical Inc. 1501 Industrial Road San Carlos, CA 94070 USA Telephone +1 650 802 0400 Fax +1 650 802 0401 Technical Service +1 888 496 2887 Technical Service Fax +1 650 802 8680 E-mail: [email protected] Customer Service +1 888 622 2427 Customer Service Fax +1 650 802 6620 E-mail: [email protected] International Support - Please contact your local Distributor. Distributor locations can be found at www.natus.com 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® cozy LED Phototherapy User Manual PN 051914 Rev. B

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Contents

Contents 1 Product Description ... 1 2 Safety Information ... 3 2.1 Explanation of Terminology... 3 2.2 General Safety Information ... 3

3 Components and User Controls ... 7 3.1 Light Enclosure and Accessories ... 7 3.2 Panel Controls... 7

4 Assembly and Operating Instructions ... 9 5 Troubleshooting Guide ... 11 6 Routine Cleaning and Maintenance... 12 6.1 Checking the Light Intensity... 12 6.2 Adjusting the Light Intensity ... 12 6.3 Cleaning ... 12

7 Technical Reference... 14 8 Specifications ... 15

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Product Description The neoBLUE® cozy LED Phototherapy System consists of four components: the neoBLUE cozy phototherapy light source (light), the neoPAD mattress, the disposable mattress cover and the power supply. Intended Use The neoBLUE cozy LED phototherapy light is intended for the treatment of neonatal hyperbilirubinemia. The light can be used for infants in a bassinet, open bed, or radiant warmer. The neoBLUE cozy device can be used in incubators under certain conditions. Warning! Placement Within an Incubator: The light is not designed to be used in an oxygen-enriched environment. Only use in the presence of room oxygen. The operating temperature for the neoBLUE cozy device is 68º – 86º F (20º – 30º C). Though the device will initially operate in warmer conditions when new, use in warmer environments will shorten the life of the LED panel. Monitor patient temperature when used in warmer environments. Important! Before assembling the neoBLUE cozy 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 cozy Phototherapy System is a 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. The neoBLUE cozy light was designed for use within a patient enclosure, positioned under the baby. 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) region of the spectrum, so there is no concern about UV exposure to the infant. As with all phototherapy lights, protective eyeshades must be used to protect the infant’s eyes from excessive light exposure. LEDs have minimal light output degradation over their lifetime with proper use. Nevertheless, the biomedical engineer can adjust the output of the LEDs using the potentiometer located behind the filter housing at the flat end of the light enclosure. The light is expected to operate on high intensity approximately 3,000 hours with an additional 6,000 hours of use at intensities below 30 µW/cm2/nm. Use in warmer environments may become more limited after 3,000 hours in use.

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Warning! Do Not Use as a Bed: The light must be placed securely within patient enclosures (such as a bassinet) to prevent patient injury.

Power Requirement Information The light is mains-power operated to the power supply, which is doubleinsulated for Class II equipment. The power supply provides 12 V to the device at up to 65W. The power cord plugs into a receptacle at the power inlet at the underside of the light enclosure. Warning! Use Care When Handling the Power Supply: The power supply will get hot under certain conditions (e.g. warm operating environment). Use the power supply holder to minimize handling of the power supply itself.

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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 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. The neoBLUE cozy light is a Class B device (CISPR 11 Classification), which is allowed in domestic establishments when used under the jurisdiction of a health care professional. Warning! Do Not Use as a Bed: The light must be placed securely within patient enclosures (such as a bassinet) to prevent patient injury. Warning! Placement Within an Incubator: The light is not designed to be used in an oxygen-enriched environment. Only use in the presence of room oxygen. Warning! Eye Protection: Do not look directly into the LEDs. During treatment, always protect the baby’s eyes with eye patches or neoBLUE® cozy LED Phototherapy User Manual PN 051914 Rev. B

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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! Place Infant with Head at Rounded End of Device: The infant should be placed with the head at the curved end of the device. The fan, located at the wider foot of the device may generate higher levels of noise. The device has an outline of a baby’s head and feet to indicate proper orientation of the baby. Warning! Do Not Use without Mattress and Mattress Cover: The device must be used with the supplied Natus neoPAD mattress and mattress cover in place to reduce potential overheating of the infant and the potential for sore spots. 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. Infants with high fever should be carefully monitored. 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! 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. The operating temperature for the neoBLUE cozy device is 68º – 86º F (20º – 30º C). Warning! Operator Safety: Sensitive individuals may experience headache, nausea or mild vertigo if he/she stays too long in the illuminated area. Use of blanket rolls, bumpers or specially designed accessories will help block light to the caregiver. The unit should be turned off when a baby is not on the mattress or when the caregiver is attending to the baby. Warning! Photoisomers: Bilirubin Photoisomers may cause toxic effects. 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). neoBLUE® cozy LED Phototherapy User Manual PN 051914 Rev. B

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Warning! Power Supply Type: Use device only with provided Natus power supply P/N 600157. Warning! Power Supply Placement: Use the supplied holder for the power supply to hook the power supply to the outside of the bassinet or suitable location. Take care to route cables so that they do not pose any hazards. Warning! Use Care When Handling the Power Supply: The power supply will get hot under certain conditions (e.g. warm operating environment). Use the power supply holder to minimize handling of the power supply itself. 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. The service manual is available on the CD that shipped with the device. Safety Symbols Warning! Be aware of the following symbols, which appear on the light/accessories. Symbol Meaning Type BF rated for patient-applied parts Double-insulated (Class II) On (power on) Standby (power off) Attention, consult product documentation Consult Instructions for Use Always protect the baby's eyes with eye patches or equivalent Single-use only neoBLUE® cozy LED Phototherapy User Manual PN 051914 Rev. B

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Symbol

Meaning Do not use in presence of enriched oxygen or flammable anesthetic gases Operating conditions DC Voltage Authorized European Representative

Manufacture Date YYYY

Manufacturer natus

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

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Components and User Controls

3.1 Light Enclosure and Accessories The neoBLUE cozy includes the components shown in the following figure.

Main Device Components

Mattress Cover:

neoPAD Mattress:

Light Enclosure:

Power Supply:

Timer

Front vent & filter:

3.2 Panel Controls On/Standby Switch: Use this switch to turn the unit ON ( | ) or to place the unit on STANDBY ( ). The switch is located on the top of the enclosure. Power Cord Attachment: The power cord attachment is at the bottom of the device on the side marked with a plug symbol. Indicating LED: The red indicator light located at the top of the enclosure provides visual feedback by blinking if the unit has overheated (surface temperature is above 40° C / 104° F). It turns on whenever the surface temperature is too warm. The blue treatment LEDs automatically turn off to reduce the temperature while the fan will continue to run. The vents should be checked to ensure they are not blocked. When the unit has cooled down sufficiently, the blue treatment LEDs turn back on automatically. The indicating LED stays on to indicate that an overheating situation has occurred. This may be reset by toggling the On/Standby switch off and back on. neoBLUE® cozy LED Phototherapy User Manual PN 051914 Rev. B

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Vents: There are vents located at the front and back of the light enclosure. A ventilating fan prevents the unit from overheating. If the fan ceases to operate, contact Natus Technical Service or your authorized service provider. Warning! To avoid overheating the light, do not cover vents (refer to section 6.3, “Cleaning” for more information on vents). Timer : The neoBLUE cozy 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 on/standby switch is in the ON position. The last digit refers to tenths of hours, with 0.1 = 6 minutes. The timer cannot be reset and is replaced along with the LED board during service. Warning! The device should be in the STANDBY ( ) position whenever the timer is read to avoid looking directly at the light.

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Assembly and Operating Instructions

Operating Instructions The neoBLUE cozy phototherapy device can be used in a bassinet, open bed or on a warming table. Preparing the neoBLUE cozy phototherapy device for use: • • •

Place the neoBLUE cozy phototherapy device in a bassinet, open bed or on a warming table. Position the neoBLUE cozy phototherapy device so that the air vents have unobstructed air movement. The power cord of the neoBLUE cozy phototherapy device should be routed to safely exit the patient area, with the power supply hanging from the outside of the bassinet or other appropriate location, and plugged into a medical-grade power outlet.

Warning! When in use, check that the air vents are not covered with blankets or clothing or positioned against obstructing surfaces. • • • •

Attach the mattress cover onto the mattress. Place the mattress flat into the neoBLUE cozy phototherapy device. Check that the mattress and cover are flat and in position within the neoBLUE cozy phototherapy device. Place blanket rolls or bumpers around the inside perimeter of the device as desired.

Caution: Use care to not block the vents and light delivery to the infant when using blankets and/or bumpers. • •

Turn on the neoBLUE cozy phototherapy device by moving the power switch to the ON ( | ) position. Measure the light intensity of the neoBLUE cozy phototherapy device. Refer to Section 6.1, “Checking the Light Intensity.”

Warning! Some individuals are sensitive to blue light, so you may need to turn the neoBLUE cozy phototherapy device to the STANDBY ( ) position while preparing the infant. Administering phototherapy treatment: Warning! Select only infants for whom phototherapy has been prescribed.

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• • • • •

Cover the infant’s eyes with protective eye shields prior to initiating phototherapy. Place the infant in the neoBLUE cozy phototherapy device on top of the covered mattress. The infant’s head should be positioned at the curved end of the device. Blankets, rolls, head protectors or bumpers can be placed within the device as needed. Ensure that they do not compromise the phototherapy treatment to the infant. Turn on the neoBLUE cozy phototherapy device by moving the power switch to the ON (I) position.

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.

•

Place the unit on STANDBY ( 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.

•

Measure patient temperature regularly, especially when used with thermotherapy.

) when checking the baby’s condition and visualizing

Warning! When in use, check that the air vents are not covered with blankets or clothing or positioned against obstructing surfaces. Warning! Some individuals are sensitive to blue light, so you may need to turn the neoBLUE cozy phototherapy device to the STANDBY ( ) position while attending to the infant.

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Troubleshooting Guide Note: Service Manual available separately on CD. In the USA, contact Natus Technical Service at +1 (888) 496-2887 or +1 (650) 802-0400, or E-mail: [email protected]. Outside of the USA, contact your local distributor. Warning! Disconnect power cord before opening the light for repair. Problem

Probable Cause

The unit does not turn No power on, fan is off. Defective switch Defective power supply

Action • 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.

Some LEDs are not lit.

One LED may have • Have a qualified technician test the burned out, causing three intensity level and readjust the LEDs to go off. intensity potentiometers to achieve the desired output, if required.

The light turns on but the fan is off.

Defective fan

• Clean fan (Refer to section 6.3)

Defective wiring Fan is jammed due to debris.

• Contact Natus Technical Service or authorized service provider if problem persists.

Device has overheated, caused by:

• Remove any material that may be blocking airflow through the vents.

The fan turns on but the blue lights are off. Red indicator LED is blinking. Blue lights may turn on and back off after a few minutes.

Blocked vents

• Remove the filter housing from the device and wash the filter. Allow Filter is clogged filter to dry before placing back on Device being used in device. operating temperature • Excessive heat may be trapped above 30ºC underneath the neoBLUE cozy LED panel near end of life device if it is placed directly on top PCB board is damaged of a soft mattress. Try removing any mattress underneath the device and allowing the device to lie on a flat, hard surface. • Use the device in a cooler environment. • Replace LED panel. • Contact Natus Technical Service or authorized service provider if problem persists.

All blue LED's flashing, red light not blinking, fan running

PCB board is damaged

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• Contact Natus Technical Service or authorized service provider if problem persists.

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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 before each use, and at least every six months. Place photometer in center of mattress, on top of disposable cover to take measurement. The light intensity output of the neoBLUE cozy 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. Note: The intensity of the light is not adversely affected if a few LEDs burn out. (The LEDs are installed in groups of three, so failure of a single LED normally causes three to fail.) 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, then the light should be readjusted. Please refer to the Service Manual.

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 non-caustic commercial cleaner, or hospital disinfectant. Caution: Observe the following precautions: • • • • • •

While the device is splash resistant to IPX4 standards, avoid spraying 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. The mattress is not machine washable. The disposable mattress cover is single patient use only and should not be reused.

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Note: To ensure correct operating temperature, the front and rear vents should be kept clear and free of dust. As part of routine maintenance, the vent filter should be cleaned every month: The filter housing is located at the flat end of the device and held in place magnetically. Locate the hole on the standoff, indicated in the figure below. Remove the filter housing from the device by inserting a pen or other pointed tool into the hole and pull away from the enclosure.

Removing the Filter Housing

Remove the filter from the housing and rinse under warm water. Initially dry the filter with paper towels, and allow to air dry before placing back into the housing. An extra filter is provided so the device can be used while a filter is being cleaned. Place the filter back into the housing ensuring it completely covers all the vents. Place the filter housing back onto the device so that it is flush with the enclosure. •

Cleaning the neoBLUE cozy phototherapy device and mattress may be accomplished with standard hospital disinfectants.

•

The mattress cover is disposable, intended for single-use only, and should be discarded according to hospital policy.

Caution: Do not submerge the mattress or the neoBLUE cozy phototherapy device under water and avoid getting fluids in air vent areas. The device complies with IPX4 water ingress safety requirements. The filter housing must be properly installed for proper protection against water ingress.

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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 > 30 µW/cm2/nm at the patient surface. This measurement is taken at the central area of the effective surface area for phototherapy.

Photometer: Intensity (µW/cm2/nm):

neoBLUE® cozy LED Phototherapy User Manual PN 051914 Rev. B

Ohmeda BiliBlanket® Meter

Joey Dosimeter Model JD-100

Olympic Bili-Meter™

35

91

approx. 14-20

15

38

approx. 4-8

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Specifications Light Source

Blue LEDs

Wavelength

Blue: Peak between 450 and 470 nm

Intensity

Peak intensity at patient surface > 30 µW/cm2/nm

Variation in intensity over 6 hrs

± 10% (within illumination area)

Effective treatment surface area

>Approximately 17.5 in (44.5 cm) X 8.5 in (21.6cm), >95 in2 (613 cm2)

Patient area

10.7 in (27.18 cm) x 22 in (55.85 cm)

Intensity ratio

> 0.4 (minimum to maximum)

Heat output

104° F (40° C) maximum surface temperature

Electrical Specifications Input Voltage

100 – 240 V~

Current

2.0 A maximum @ 100 – 240 V ~

Frequency

50 – 60 Hz

Power Supply Output

(use only with Natus Power Supply 600157)

Voltage

12 V

Power

65 W maximum

Current

5.4 A @ maximum @ 12 V

Safety Main enclosure leakage current

< 100 μA

Earth leakage current

< 250 μA

Audible Noise

< 60 dB

Dimensions Width x Length x Height (Enclosure):

12 in (30.5 cm) x 25.5 in (64.8 cm) x 4.0 in (10.2 cm)

Weight:

< 11.0 lbs (5.0 kg) (Enclosure + Power Supply)

Environmental Operating Temperature/Humidity

68° to 86° F (20 to 30° C) / 10% to 90% non condensing

Storage Temperature/Humidity

-22° to 122° F (-30 to 50° C) / 10% to 90% non condensing

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Regulatory Standards FDA classification: Electrical Safety: Type BF MDD Classification: Electrical Safety: EMC [Class B]: Labeling: Risk Analysis: Device specific safety: Biocompatibility:

neoBLUE® cozy LED Phototherapy User Manual PN 051914 Rev. B

Class II/21CFR 880.5700 UL60601-1:2003, CSA C22.2 601-1-M90 IIa, (Annex IX, Rule 9, active therapeutic device) EN 60601-1:1990; A1:1993; A2:1995; A13:1996 EN 60601-1-2:2002 EN1041:1998, EN980:2003 ISO 14971:2000; A1:2003 EN60601-2-50:2002 EN ISO10993-1:2003; EN ISO10993-5:1999; EN ISO10993-10:2002

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