neoBLUE blanket LED Phototherapy User Manual (006281E)

neoBLUE blanket User Manual

TABLE OF CONTENTS 1. PRODUCT DESCRIPTION ... 5 1.1.

Intended Use ... 5

1.2.

Physical Characteristics... 5

1.3.

Power Requirement Information... 5

2. SAFETY INFORMATION... 6 2.1.

Explanation of Terminology ... 6

2.2.

General Safety Information ... 6

2.3.

Safety Symbols ... 9

3. COMPONENTS AND USER CONTROLS ... 11 3.1.

neoBLUE blanket LED Phototherapy System ... 11

3.2.

Light Box ... 11

3.3.

Controls... 12

4. ASSEMBLY AND OPERATING INSTRUCTIONS ... 12 4.1.

Preparing the neoBLUE blanket LED Phototherapy System for use: ... 12

4.2.

Administering phototherapy treatment: ... 13

5. TROUBLESHOOTING GUIDE ... 14 6. ROUTINE CLEANING AND MAINTENANCE... 15 6.1.

Checking the Light Intensity ... 15

6.2.

Adjusting the Light Intensity... 15

6.3.

Cleaning ... 15

7. TECHNICAL REFERENCE ... 16 8. SPECIFICATIONS ... 17 8.1.

Light Source ... 17

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8.2.

Power Supply Specifications ... 17

8.3.

Safety... 17

8.4.

Dimensions ... 17

8.5.

Environmental ... 17

8.6.

Regulatory Standards ... 18

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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 cover and the power supply. 1.1. Intended Use The neoBLUE blanket LED Phototherapy System is intended for the treatment of neonatal hyperbilirubinemia. It can be used in the clinical setting or in the home. The neoBLUE blanket device provides phototherapy underneath the infant and can be used in a bassinet, open bed, radiant warmer, incubator, or while holding the infant. Important! Before assembling the neoBLUE blanket and administering phototherapy, 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 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 neonatal hyperbilirubinemia. 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 infant. As with all phototherapy lights, protective eyeshades must be used to protect the infant’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 rear base of the light box. The light is expected to operate on high intensity 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 preageing period prior to initial use. It also does not require a stabilization (burn-in) period prior to each use. The neoBLUE blanket device comes with a large or small size blanket. The light box automatically recognizes which blanket size is being used to deliver consistent phototherapy levels. Note: Optional mounting hardware is available for pole-mounting applications. 1.3. Power Requirement Information The light is mains-power operated to the power supply 100-240V AC, which is doubleinsulated for Class I equipment. The power supply provides 12V DC to the device at up to 100W. The power cord plugs into a receptacle at the power inlet at the rear of the light box.

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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 device. Note: Information in this category is not considered precautionary, it is 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! The neoBLUE blanket device should be used only by appropriately trained personnel and under the direction of qualified medical personnel familiar with currently known risks and benefits of infant phototherapy equipment use. Warning! 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 the device 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 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. 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. Warning! Select only infants for whom phototherapy has been prescribed. Warning! To avoid any entanglement, always place the infant on the mattress with the head opposite the end where the fiberoptic cable is attached.

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Warning! Monitor infants regularly during treatment per your institution’s procedures. Use the following guidelines:    

Measure the patient’s bilirubin level periodically. Turn the unit off when checking the baby’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, especially when used with thermotherapy. Periodically verify that the baby’s eyes are protected and free of infection.

Warning! Some individuals are sensitive to blue light, so you may need to turn off the neoBLUE blanket LED Phototherapy System while attending to the infant. 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 blanket device in a well-lighted area or wearing glasses with yellow lenses can alleviate potential effects. 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! Eye Protection: Do not look directly into the emitted light. During treatment, protect the baby’s eyes with eye patches or equivalent, when eyes can be exposed to the phototherapy light. Patients adjacent to the light may also need to be protected with eye patches or equivalent. Warning! Do Not Use without blanket mattress and disposable blanket cover: The device must be used with the supplied Natus mattress and cover in place to ensure proper treatment uniformity. Warning! Placement Within an Incubator: The light box is not designed to be used in an oxygen-enriched environment. Only use in the presence of room oxygen. It is acceptable to use the fiberoptic blanket within an incubator. Warning! Combustible Gases: Do not use the light box in the presence of gases that support combustion (for example, oxygen, nitrous oxide, or other anesthetic agents). It is acceptable to use the fiberoptic blanket in the presence of combustible gases. Warning! Skin Temperature: The use of skin-controlled (baby-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 a 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.

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Warning! Ambient Conditions: Varying 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 blanket is 68°- 86° F (20°- 30° C). 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! Power Supply Type: Use device only with provided Natus power supply P/N 007121. Warning! Fiberoptic Blanket Type: Use device only with provided Natus neoBLUE fiberoptic blanket(s). Warning! Power Supply Placement: Take care to route cables so that they do not pose any hazards. Warning! To avoid overheating the light box, check that the air vents are not covered with blankets or clothing or positioned against obstructing surfaces. Warning! Disconnect Electrical Power: Always switch off the power and disconnect the power cord when cleaning the device. Warning! Disconnect power cord before opening the light box for repair. Warning! The use of 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. Warning! The neoBLUE blanket device should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the device should be observed to verify normal operation in the configuration in which it will be used. Important! Use of Nonstandard Components: The unit uses a specific type of LED. Consult the manufacturer for repair and replacement. 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. Important! Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in accompanying documents.

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Important! Portable or mobile RF communications equipment can affect the performance of the neoBLUE blanket. If used in the presence of RF communications equipment, the device should be observed to verify normal operation. Caution: Only qualified personnel should perform service and repair. Caution: Avoid spraying liquids directly onto the light box, or allowing them to seep into the interior. Caution: Never immerse the light box or any component parts in liquid. Caution: Do not use caustic or abrasive cleaners. Caution: Do not clean with alcohol, acetone, or other solvents. Caution: The mattress is not machine washable. Caution: The mattress cover is disposable, intended for single-use only, and should be discarded according to hospital policy.

2.3. Safety Symbols Warning! Be aware of the following symbols, which appear on the device/accessories. Symbol

Meaning Type BF rated for patient-applied parts

On (power on)

Standby (power off)

Attention, consult product documentation

Consult Instructions for Use

Protect the baby's eyes with eye patches or equivalent

Single-use only

Operating conditions

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Symbol

Meaning DC Voltage

Authorized European Representative

Manufacture Date YYYY

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. neoBLUE blanket LED Phototherapy System

3.2. Light Box

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3.3. Controls On/Standby Switch: Use this switch to turn the unit ON ( | ) or place on 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 treatment light until the switch is ON and a fiberoptic cable is inserted into the fiberoptic coupler. Power Cord Attachment: The power cord attachment is at the rear of the light box. Over-Temperature Indicator Light: The indicator light located next to the switch at the rear of the light box provides visual feedback by blinking amber if the unit has overheated. The blue treatment light automatically turns 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 light turns back on automatically. The indicator light will continue blinking amber to indicate that an overheating situation has occurred. This may be reset by toggling the On/Standby switch off and back on. Vents: There are vents located at the sides of the light box. A ventilating fan prevents the unit from overheating. Warning! To avoid overheating the light box, check that the air vents are not covered with blankets or clothing or positioned against obstructing surfaces. Timer: The neoBLUE blanket 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 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.

4. Assembly and Operating Instructions 4.1. Preparing the neoBLUE blanket LED Phototherapy System for use:  Place the neoBLUE fiberoptic blanket with mattress in a bassinet, open bed, warming table or incubator. 

Position the neoBLUE blanket light box so that the air vents have unobstructed air movement and insert fiberoptic cable into 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: The light box may be placed on a flat surface or mounted to a pole using optional hardware. 

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The power cord should be routed to safely exit the patient area and plugged into outlet.

Warning! To avoid overheating the light box, check that the air vents are not covered with blankets or clothing or positioned against obstructing surfaces. 

Apply disposable mattress cover to blanket mattress (Replacement covers can be ordered from Natus Medical Incorporated). Note: Mattress comes already installed over fiberoptic blanket. Mattress is semidurable (replacement mattresses can be ordered from Natus Medical Incorporated).

 

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

4.2. Administering phototherapy treatment: Warning! Select only infants for whom phototherapy has been prescribed. Warning! To avoid any entanglement, always place the infant on the mattress with the head opposite the end where the fiberoptic cable is attached. 

Cover the infant’s eyes with protective eye shields prior to initiating phototherapy. Note: During periods when the infant is being held and positioned so that their eyes cannot be exposed to the light, protective eye shields can be removed.

 

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Place the infant on top of the neoBLUE blanket covered mattress. Blankets, rolls, head protectors or bumpers can be placed around the neoBLUE blanket mattress as needed. Ensure that they do not compromise the phototherapy treatment to the infant

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

Turn on the neoBLUE blanket LED Phototherapy System by moving the power switch to the ON ( | ) position

Warning! Monitor infants regularly during treatment per your institution’s procedures. Use the following guidelines:    

Measure the patient’s bilirubin level periodically. Turn the unit off when checking the baby’s condition and visualizing skin color; blue light can hinder clinical observations for masking skin color changes, such as cyanosis. Monitor patient temperature and fluid status (water balance), especially when used with thermotherapy. Periodically verify that the baby’s eyes are protected and free of infection.

Warning! Some individuals are sensitive to blue light, so you may need to turn off the neoBLUE blanket LED Phototherapy System while attending to the infant.

5. Troubleshooting Guide Note: Service Manual available separately on CD. In the USA, contact Natus Technical Service at +1 (800) 303-0306 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 box for repair.

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. Blue light may be on or off.

Device has overheated,  Remove any material that may be caused by: blocking airflow through the vents. Blocked vents  Use the device in a cooler environment. Device being used in operating temperature above  Contact Natus Technical Service or 30ºC authorized service provider if problem Circuit board is damaged persists. Fan failure

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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, 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 blanket is measured at Natus prior to shipment with the Natus neoBLUE Radiometer. 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 neoBLUE Radiometer reading. 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. 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 Electrical Power: Always switch off the power and disconnect the power cord when cleaning the device. Using a soft cloth dampened with mild detergent or 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 be accomplished with standard hospital disinfectants. Caution: Avoid spraying liquids directly onto the light box, or allowing them to seep into the interior. Caution: Never immerse the light box or any component parts in liquid. Caution: Do not use caustic or abrasive cleaners. Caution: Do not clean with alcohol, acetone, or other solvents. Caution: The mattress is not machine washable. Caution: The mattress cover is disposable, intended for single-use only, and should be discarded according to hospital policy.

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7. Technical Reference The following graph shows the total spectral irradiance for bilirubin of the neoBLUE blanket LED Phototherapy System.

The intensity of the light is > 30 μW/cm2/nm at the patient surface. This measurement is taken with a radiometer at the central area 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. The light intensity output of the neoBLUE blanket device is measured at Natus prior to shipment with the neoBLUE Radiometer.

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8. Specifications 8.1. Light Source Blue LED Wavelength Blue: Peak between 450 and 475 nm Peak intensity at patient surface: >30 µW/cm2/nm (factory set to 30-35 µW/cm2/nm; adjustable to > 50 µW/cm2/nm) Variation in intensity over 6 hrs: < 10% (within illumination area) Light emitting area (large blanket): Approximately 9.5 in (24.1 cm) x 14.5 in (36.8 cm), 127 in2 (819 cm2) Light emitting area (small blanket): Approximately 6.75 in (17.1 cm) x 12.75 in (32.4 cm), 84 in2 (542 cm2) Effective treatment area (large blanket): Approximately 78.1 in2 (504 cm2) Effective treatment area (small blanket): Approximately 45.9 in2 (296 cm2)

Intensity ratio: > 0.4 (minimum to maximum) Heat output: 104° F (40° C) maximum surface temperature 8.2. Power Supply Specifications Input Voltage: 100 – 240VAC Current: 1.5A Frequency: 50 – 60 Hz Output Voltage: 12 V Power: 100W maximum Current: 8.3A 8.3. Safety Main enclosure leakage current < 100 μA Earth leakage current < 250 A Audible Noise < 40 dB 8.4. Dimensions Size - Light Box (W x L x H): 4.5 in x 9 in x 5.5 in (11.4 cm x 22.9 cm x 14 cm) Weight - Light Box: 3.3 lb (1.5 kg) 8.5. 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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8.6. Regulatory Standards FDA classification: Class II/21CFR 880.5700 MDD Classification: IIa, (Annex IX, Rule 9, active therapeutic device) Electrical Safety: UL60601-1:2006, CSA C22.2 601-1-M90:2005, IEC 60601-1:1988; A1:1991; A2:1995 EMC [Class B]: IEC 60601-1-2:2007 Device specific safety: IEC 60601-2-50:2000 Biocompatibility: ISO10993-1:2003; ISO10993-5:1999; ISO10993-10:2002 with respect to electrical shock, fire and mechanical hazards only in accordance with UL 60601-1, IEC 60601-2-50.

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