neoBLUE blanket Service Manual Rev B Nov 2018

Federal Law (U.S.) restricts this device to sale or use by or on the order of a physician (or properly licensed practitioner). Natus, Biliband and neoBLUE are registered trademarks of Natus Medical Incorporated. © 2018 Natus Medical Incorporated. All rights reserved.

This manual may not be reprinted or copied in whole or in part without written consent from Natus Medical Incorporated. The content of this manual may change without notice. Natus Medical Incorporated 5900 First Avenue South Seattle, WA 98108 USA Telephone +1 650 802 0400 Fax +1 650 802 0401 Technical Service +1 888 496 2887 E-mail: [email protected] Customer Service +1 800 303 0306 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 Natus Manufacturing Limited IDA Business Park Gort, Co.Galway Ireland 0086

neoBLUE blanket LED Phototherpay System Service Manual P/N 023854 Rev B

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1.

Product Description ... 4

1.1.

Intended Use ... 4

1.2.

Indications for Use ... 4

1.3.

Patient Population ... 4

1.4.

General Characteristics ... 4

1.5.

Light Source ... 4

1.6.

Power Requirement Information... 5

1.7.

Additional References ... 5

1.8.

Safety Symbols ... 6

2.

Routine Maintenance Procedures ... 7

2.1.

Cleaning ... 7

2.2.

Performance Verification... 8

2.3.

Safety Testing ... 11

3.

Troubleshooting the neoBLUE blanket Light... 11

4.

Repair Procedures ... 15

4.1.

General disassembly ... 16

4.2.

Removing/Replacing the Unit Power Jack (PN 007672) ... 20

4.3.

Removing/Replacing the ON/Standby Switch (PN 007670) ... 20

4.4.

Removing/Replacing the Coupling (PN 017944) ... 21

4.5.

Removing/Replacing the Fan (PN 007673) ... 22

4.6.

Removing/Replacing the PCB Assembly (PN 019492) ... 22

4.7.

Removing/Replacing the Timer (PN 017945) ... 23

4.8.

About the Device Timer/Resetting the Timer (PN 017945) ... 23

4.9.

Spare Parts List ... 24

5.

Specifications ... 25

5.1.

Regulatory Standards ... 26

6.

Technical Reference ... 27

7.

APPENDIX A: Verify Light Intensity ... 28

8.

APPENDIX B: Electromagnetic Compatibility (EMC) Specifications ... 29

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1. Product Description The neoBLUE® blanket LED Phototherapy System consists of five components: the neoBLUE blanket phototherapy light box, the fiber-optic blanket with cable, the blanket mattress, the disposable mattress covers and the power supply. 1.1. Intended Use The neoBLUE blanket LED Phototherapy System is intended for the treatment of unconjugated hyperbilirubinemia in premature babies and neonates. It is intended for use with patients up to 3 months of age, weighing less than 22 lb (10 kg). 1.2. Indications for Use The neoBLUE blanket LED Phototherapy System is indicated for the treatment of unconjugated hyperbilirubinemia in a hospital environment, and administered by trained professional medical staff, on the order of a physician, or in the home environment administered by a trained caregiver. The neoBLUE blanket device provides intensive phototherapy underneath the patient and can be used with a bassinet, open bed, radiant warmer, incubator, or while holding the patient. 1.3. Patient Population When treating term and near-term neonates with intensive phototherapy for treatment guidance, please refer to the AAP Guidelines (American Academy of Pediatrics Clinical Practice Guideline – Management of Hyperbilirubinemia in the Newborn Patient 35 or More Weeks of Gestation). When treating preterm neonates with intensive phototherapy, please seek guidance from physician on duration of the treatment as well as appropriate patient monitoring. Note: Under the direction of a physician, the neoBLUE blanket device may be used in the home environment. Refer to your hospital policy and procedure regarding user training for caregiver and service of the device when used at home. The caregiver must be provided with the ‘neoBLUE blanket Guide for Home Use’ for adequate use of the device and must follow the direction provided by physician for duration of the treatment. 1.4. General 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. 1.5. Light Source The blue LED emits light in the range of 400 – 550 nm (peak wavelength 450 – 475 nm). This range corresponds to the spectral absorption of light by bilirubin, and is thus considered to be the most effective for the degradation of bilirubin. The blue LED does not emit significant energy in the ultraviolet (UV) region of the spectrum, so there is no concern about UV exposure to the infant. As with all phototherapy lights, protective eyeshades such as the Natus Biliband® Eye Protectors 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 LED is expected to operate on high intensity (≥30 µW/cm2/nm) approximately 20,000 hours. Actual results will vary based on environmental factors and

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adjustments to the potentiometer. Due to the nature of the LED light source, this device does not require a pre-ageing period prior to initial use. It also does not require a stabilization (burn-in) period prior to each use. The neoBLUE blanket system comes with a large or small size blanket. The life expectancy of the fiber-optic blanket will vary with use conditions and adjustments to the potentiometer. Pole-Mounting Hardware (optional) Optional hardware is available for pole-mounting applications. The neoBLUE blanket pole-mounting hardware is designed to attach to poles with 0.75 to 1.5 inch (1.91 to 3.81 cm) diameters. 1.6. Power Requirement Information Mains-power (100-240 VAC) at either 50 or 60 Hz is provided to the external power supply, which is double-insulated for Class II equipment. The external power supply provides 12 VDC to the light box at up to 72 W. The power cord from the external power supply connects to a receptacle at the rear of the light box. 1.7. Additional References Note: neoBLUE blanket device User Manual is available separately. Contact Natus Global Sales & Support: +1 (800)-303-0306 (toll-free, USA only) or +1 (650)-802-0400, or E-mail: [email protected]. (U.S., Asia, Australia, South America). Outside the US, please contact your local distributor for service.

FIGURE 1

neoBLUE blanket LED Phototherapy System Service Manual P/N 023854 Rev B

FIGURE 2

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1.8. Safety Symbols Symbol

Meaning Refer to instruction manual Consult Instructions for Use Caution Warning Type BF patient-applied part On (power on) Standby (power off)

IPX3

Protected against spraying water

IP21

Protected from condensation Protected against insertion of fingers or become unsafe during dripping water Protect the patient's eyes with eye patches or equivalent Single-use only Operating conditions DC Voltage Authorized European Representative

Manufacture Date

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Symbol

Meaning Manufacturer

Double-insulated (Class II)

Prescription use only

Do not use in MRI Environments

Disposal at end of life instructions

Disposal of Equipment: When the equipment comes to the end of its operating life, it should be disposed of in accordance with local waste regulation authority, which is typically within the local government office. 2. Routine Maintenance Procedures This section describes routine maintenance procedures for the neoBLUE blanket light box. • • •

Cleaning (Section 2.1) Performance Verification (Section 2.2) Safety Testing (Section 2.3)

These procedures must be performed after any of the following events and/or as prescribed by the institution’s maintenance schedule. • • • •

Initial receipt of the light box at the institution. Every 6 months for light intensity. Light box has been physically damaged or subjected to mechanical shock (i.e., being dropped). Light Box has been submitted for maintenance or scheduled performance verification.

2.1. Cleaning Cleaning of the light box should be performed on a routine basis or whenever any foreign material or liquid has been deposited on the light box. Disconnect power cord from light box before cleaning. 2.1.1 Cleaning the exterior of the Light Box and Blanket/Mattress Remove the blanket/mattress from the light box. Remove and discard the disposable mattress cover if necessary. Clean the exterior of the light box and blanket/mattress with

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a mild solution of detergent and water, non-caustic commercial cleaner, or hospital disinfectant. Observe the following precautions: • • • • • •

While the light box is splash resistant to IP21 standards, avoid spraying liquids directly onto the light box, and do not 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 mattress, the light box, or its component parts in any liquid. The mattress is not machine washable. The disposable mattress cover is single patient use only and should not be reused.

2.2. Performance Verification This section discusses the tests necessary to verify Light Box performance. • Verifying General Performance (Section 2.2.1) • Adjusting the Light Intensity (Section 2.2.2) All tests can be conducted without removing the light box light enclosure. If the light box fails to conform or cannot be adjusted to conform, repairs must be made to correct the problem before the instrument is returned to the user. Tools and Test Equipment

Type

Radiometer

Natus neoBLUE® Radiometer (P/N 53870)

Potentiometer Adjustment Tool

GC Electronics 8608 or equivalent

Safety Glasses

Guard Dog Bones glasses are recommended and are available online at www.safetyglassesusa.com or via phone at 1-800-8706189.

Thermometer

Use a model appropriate for measuring surface temperature

Work Pad

Any non-abrasive non-static surface

Multimeter

CAT II Rated

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. Intensity measurements are based on the patient surface using Natus mattress and disposable mattress cover. Use of other components may produce unexpected levels of light intensity.

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2.2.1 Verifying General Performance 1. Confirm air vents are not blocked. 2. Connect the power supply DC power cord to the light box DC input and the power supply AC cord to an AC receptacle. 3. Switch the light on and plug in the fiber-optic blanket. 4. Verify the ventilation fan is running and the fiber-optic blanket lights up. 5. If necessary, remove the mattress and mattress cover from the fiber-optic blanket. 6. Examine light panel geometry for unlit fibers. Note: The light box can conform to specifications with some fibers unlit. However, if a large number are unlit, the light box may not meet minimum values. Light intensity may need to be increased if many fibers are unlit. Increasing intensity will reduce LED life. 7. Place the mattress and mattress cover back on the device. 8. Place the radiometer sensor lens facing down, in the approximate center, on top of the mattress/cover. Note: It is important that the radiometer sensor be parallel to the blanket/mattress plane. 9. After a stable reading is attained, move the radiometer to find the peak light intensity reading. The peak intensity location should be in the approximate center of the mattress. 10. If the radiometer reading is between 35 ± 5 µW/cm2/nm, skip to step 12. 11. If the reading is not within range, leave the radiometer in position and skip to Section 2.2.2, Adjusting Light Intensity. 12. If all previous steps generate satisfactory results, the light box performance has been verified and the light box can be returned to the user. Switch the light box off and return it to service. 2.2.2 Adjusting Light Intensity Light intensity is controlled by a potentiometer located on the underside of enclosure, inside a recess (see Figure 3). Please follow ESD safe procedures when adjusting this potentiometer. Note: It is optional to get 1” inch thick foam and cut a rectangle to fit the light box handel and lay the unit upside down as Figure 3. Using the potentiometer adjustment tool, adjust the potentiometer marked with a “II” to a light intensity of 35 ± 5 μW/cm2/nm, or as directed by a physician, by following the instructions below, (Note: potentiometer marked by “I” is for future use.) Place the radiometer sensor lens facing down on top of the mattress provided with a disposable cover.

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FIGURE 3 1.

Switch the light on and plug in the fiber-optic blanket.

2.

Measure and record the light intensity at 5 Points as shown in Figure 4.

FIGURE 4 EXAMPLE: Point 1: 27 µW/cm2/nm Point 2: 31 µW/cm2/nm Point 3: 30 µW/cm2/nm Point 4: 26 µW/cm2/nm Point 5: 25 µW/cm2/nm 3.

Place the radiometer sensor over the location of the median value and adjust the intensity of this location to 35 µW/cm²/nm. EXAMPLE: Point 1(27 µW/cm2/nm) is the median value since there are two points with higher readings and two points with lower readings. Increase Point 1’s measured intensity until the radiometer reads 35 µW/cm2/nm.

4.

Turn the potentiometer clockwise to increase the intensity, or counterclockwise to decrease the intensity.

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Note: Adjusting the potentiometer so that intensity is greater than 35 µW/cm2/nm will decrease life of the LED component and of the blanket. 5.

Repeat step 1. Remeasure the five points and confirm the median value of the light output reads 35 µW/cm2/nm.

6.

If step 4 complies, return the light box to service.

7.

If step 4 does not comply, refer to Section 3, Troubleshooting the neoBLUE blanket.

2.3. Safety Testing The safety tests listed below meet the standards of, and should be performed in accordance with IEC 60601-1 for instruments identified as Class II, TYPE BF. Note: The power supply is double insulated. Applicable tests for these standards are listed below (Table 2.1). Technicians must be familiar with local and national standards applicable to the institution. Test equipment and its application must comply with the applicable standard. Maximum Current Limits are listed below for each test and standard. TABLE 2.1

Touch Current AC Line Cord Polarity Normal Normal Reversed Reversed

AC Line Cord Neutral Conductor Closed Open Closed Open

IEC 60601-1 100 µA 500 µA 100 µA 500 µA

3. Troubleshooting the neoBLUE blanket Light Potential Electric Shock: Disconnect power cord before opening the light box enclosure for repair. The following symptoms are discussed in this section: • • • • • • • • •

Light does not appear when device is turned on Not all fibers are producing light Over-temperature indicator light is flashing Over-temperature indicator light is double blinking Excessive noise Light intensity is below 30 µW/cm2/nm Light intensity will not adjust to 35 µW/cm2/nm Device does not operate at higher temperatures even though the ambient is less than 30°C Blue light blinks / flickers

When opening the neoBLUE blanket light box to examine the LED, follow the procedures described in section 2, Routine Maintenance Procedures and section 4, Repair Procedures.

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TABLE 3.1

Troubleshooting Guide

Potential Electric Shock: Disconnect power cord before opening the light box enclosure 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.

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 and on the other end at the AC mains outlet. If the device still will not turn on, check to see if socket or plug pins are damaged or try another power cord.

Fiber-optic cable is not properly inserted into the Light Box

Check to make sure the fiber-optic cable is fully inserted into the fiber-optic coupling in the light box.

If none of the above restores the light, open the main enclosure and check for the following:

LIGHT DOES NOT APPEAR WHEN DEVICE IS TURNED ON

Damaged power supply cable

Damaged Power Switch or PCB Assembly

Damaged Optic Module

Plug power cord in, exercising caution due to live circuit (12V DC). Check the voltage at the power jack red wire for 12 volts and black wire for GND (11.4 V To 12.6 V is an acceptable range). If an incorrect voltage is present, remove external cable from the jack and check open circuit voltage at the end of the power supply cable connector. See Figure 4a bellow (4 pins on the left side of the notch are +12 volt and 3 pins on the right side of the notch are GND). If the voltage is still incorrect, replace the power supply. Contact Natus Technical Service or authorized service provider. Plug power cord in, exercising caution due to live circuit (12V DC). Check voltage at the quick connect J4 (red wire +12V) & J5 (white wire GND) at the back side of the driver board for the following values when the switch is in the ON ( | ) position. If voltage is correct, replace the PCB. If the voltage is incorrect, verify that the power switch cable is plugged in securely and is not damaged. Unplug the red wire from the J4 and measure its voltage again for +12V. If it is incorrect, replace the power switch. Contact Natus Technical Service or authorized service provider. Contact Natus Technical Service or authorized service provider.

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SYMPTOM

NOT ALL FIBERS ARE PRODUCING LIGHT

PROBABLE CAUSE

CORRECTIVE ACTION

Individual fiber has a break in it

The device can conform to specifications with some fibers unlit. If the customer is no longer able to reach the desired treatment level, replace the fiber-optic blanket.

Connector/Coupler end has been damaged or scratched

Replace fiber-optic blanket

To reset the flashing light, turn the device off and on again.

OVER-TEMPERATURE INDICATOR LIGHT IS FLASHING

Air vents are blocked

Verify that vents are not blocked.

Device not used within specified operating temperature

Make sure that the device is not used in ambient temperature greater than 30°C. The device will turn itself off in such an ambient environment in order to prevent overheating.

Main enclosure fan is not running

Verify that fan is able to spin freely. Replace the fan if necessary. Contact Natus Technical Service or authorized service provider.

Component on PCB board has become faulty.

Replace PCB Assembly (see Section 4). Contact Natus Technical Service or authorized service provider.

Internal lens interface has overheated, caused by: Connector/Coupler end of fiber-optic cable is damaged and is at the end of its useful life

Inspect the fiber-optic cable end for signs of damage, including any signs of melting of the fibers or heavy discoloration. Replace fiber-optic blanket if there are any signs of damage.

Internal wires are in contact with the fan

Open device and verify that internal wires that are close to the fan are not damaged. Replace wires if necessary. Route wires away from fan.

Improper fit of the cover

Verify that the device is assembled correctly with no loose screws. Open the device and inspect contact points. Reassemble the device. If still noisy, contact Natus Technical Service or authorized service provider.

Device requires cleaning

Clean the surface of the blanket per Section 2.1. Replace the disposable cover if soiled and clean or replace the mattress if necessary.

Light intensity needs to be adjusted

Adjust light intensity per Section 2.2.2.

Near the end of life of the LED

LEDs slowly dim as they age and may have exceeded their useful life. Contact Natus Customer Service or authorized service provider to purchase a replacement light box.

EXCESSIVE NOISE

LIGHT INTENSITY READS BELOW 30 µW/cm2/nm

(continued on next page)

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(continued from previous page)

Damaged PCB

Replace PCB Assembly (see Section 4). Contact Natus Technical Service or authorized service provider.

Internal lens interface has overheated, caused by: Connector/Coupler end of fiber-optic cable is damaged and is at the end of its useful life

Inspect the fiber-optic cable end for signs of damage, including any signs of melting of the fibers. Replace fiber-optic blanket if there are any signs of damage.

PROBABLE CAUSE

CORRECTIVE ACTION

Light intensity needs to be adjusted

During the life of the fiber-optic pad there can be fluctuation increases of intensity readings up to 10%. Adjust light intensity per Section 2.2.2.

Natus approved mattress / disposable cover is missing

Confirm the correct mattress and cover is being used.

Natus approved mattress / disposable cover not used

The neoBLUE blanket mattress and disposable cover are specially designed for use with the neoBLUE fiber-optic blanket. Use with alternate materials will decrease the efficacy of the device.

Device requires cleaning

Clean the surface of the blanket per Section 2.1. Replace the disposable cover if soiled and clean or replace the mattress if necessary.

Damaged PCB

Replace PCB Assembly (see Section 4). Contact Natus Technical Service or authorized service provider.

Near the end of life of the LED

LEDs slowly dim as they age and may have exceeded their useful life. Contact Natus Customer Service or authorized service provider to purchase a replacement light box.

DEVICE DOES NOT OPERATE AT HIGHER TEMPERATURES EVEN THOUGH WITHIN 30°C

Near the end of life of the LED

As the device ages, the operating temperature range decreases due to the increased amount of heat generated by the Optics Module. This poses no danger to the patient as the device will automatically turn off when it reaches an overtemperature condition, the device can no longer operate at the higher temperature range. Place the device in a cooler location or Contact Natus Customer Service or authorized service provider to purchase a replacement light box.

BLUE LIGHT BLINKS / FLICKERS

PCB Assembly or Optics Module damaged

Replace the PCB assembly (see above and Section 4). Contact Natus Customer Service or authorized service provider to purchase a replacement.

SYMPTOM

LIGHT INTENSITY READS ABOVE FACTORY SETTNG (35 ± 5 µW/cm2/nm )

LIGHT INTENSITY WILL NOT ADJUST TO 35 ± 5 µW/cm2/nm

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Figure 4a – Photos of the power supply connector and its pin assignment. 4. Repair Procedures This section presents procedures for repairing the neoBLUE blanket light, referred to as the UUR (Unit Under Repair) in this section. Only qualified technical personnel should open the light enclosure, remove and/or replace components or make adjustments. If the medical facility does not have qualified personnel, please contact Natus Technical Service or your authorized service representative for further assistance. Tools Required Screwdriver – Phillips, #1 Screwdriver-- Flat Wrench -- 18mm open Pliers – Needle nose Wire cutter The Biomedical Equipment Technician must complete Performance Verification and Safety Testing procedures listed in Section 2 after any repair is completed and the UUR is reassembled. The UUR can be disassembled down to all major component parts, including: o General disassembly (Section 4.1) o Removing/Replacing the Unit Power Jack (Section 4.2) o Removing/Replacing the ON/Standby Switch (Section 4.3) o Removing/Replacing the Coupler (Section 4.4) o Removing/Replacing the Fan (Section 4.5) o Removing/Replacing the PCB Assembly (Section 4.6) o Removing/Replacing the Timer (Section 4.7) o Resetting the Timer (Section 4.8) Potential Electric Shock: Disconnect power cord before opening the light box enclosure for repair. Internal components may be hot. Exercise caution during servicing. Approved anti-static measures must be used anytime the light box is disassembled.

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1.

2.

4.1. General disassembly Place the UUR on a suitable work surface (non-abrasive, non-static). It is optional to use a 1” thick foam with a cut a rectangle shape to fit the light box handle into it for stability. Remove the five Phillips head screws on the bottom of the enclosure. Locations are indicated in Figure 5.

FIGURE 5 3.

The bottom half of the enclosure is removed by gently pulling it up from the upper half of the enclosure. Use caution; the cover may fit tightly onto the enclosure. Flip the bottom half of the enclosure over and lay it next to the unit as shown in Figure 6. Note: Be careful not to bend or deform the vent grill covers.

FIGURE 6

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4.

Disconnect brown flex cable by releasing connector clasp ends and lifting the cable as shown in Figure 7.

FIGURE 7

Note: During reassembly be extra careful as it is very easy to pinch this cable between the standoffs where the screw hold the housing together. 5.

Use a needle nose plier to gently disconnect the red and black wire terminal connectors as shown in Figure 8.

FIGURE 8 6.

Disconnect header connector with 2 white wires as shown in Figure 9.

FIGURE 9

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7.

Disconnect header connector with red and black wires as shown in Figure 10.

FIGURE 10 8.

Remove/lift Light Engine sub assembly and Coupler sub assembly as shown in Figure 11. It is easier to left the Light Engine by grabbing both side of the cooling grill while holding the base cover.

FIGURE 11 9.

Disconnect terminal connector with black wire from switch and red wire from the Driver sub assembly as shown in Figure 12.

FIGURE 12

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10.

Disconnect the white wire from switch terminal as shown in Figure 13. If the connection is tight use cation to not damage the switch or the components on the PCB.

FIGURE 13 11.

Lift out Driver PCB sub assembly from top enclosure and disconnect connector with green and orange wires as shown in Figure 14.

FIGURE 14

Note: During re-assembling install the connectors to the board before putting the board spacer back in. Then put the spacer on the board before inserting it into the unit. 12.

Push light pipe out from enclosure as shown in Figure 15.

FIGURE 15

Note: During reassembly it is important for this light tube to be lined up with the on board amber led. neoBLUE blanket LED Phototherapy System Service Manual P/N 023854 Rev B

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4.2. Removing/Replacing the Unit Power Jack (PN 007672) 1.

Steps 1-9 in Section 4.1 must be completed before beginning these steps.

2.

Separate the Unit Power Jack from the bottom enclosure by removing the hex nut (counterclockwise with 18mm open wrench).

FIGURE 16 3.

Feed replacement Unit Power Jack through hole of bottom housing, align with interlocking notch, thread hex hut (clockwise) and secure tight.

4.

Reassemble by following 4.1 steps 1-9 in reverse. Return to section 2 and complete Performance Verification and Safety Tests.

4.3. Removing/Replacing the ON/Standby Switch (PN 007670) 1.

Steps 1-12 in Section 4.1 must be completed before beginning these steps.

2.

The switch is held in the light enclosure by spring tabs, on each side of the switch. Use needle nose plier to squeeze the snaps to remove the switch, See Figure 17.

FIGURE 17

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