RODUCT ESCRIPTION ESCRIPTION The neoBLUE cozy LED Phototherapy System is a mobile phototherapy light that delivers The neoBLUE cozy LED Phototherapy System is a mobile phototherapy light that delivers narrow band high-intensity blue light via L narrow band high-intensity blue light via Light Emitting Diodes (LEDs) providing treatment for neonatal hyperbilirubinemia.
Page 5
The light operates using a 12V DC medical grade power supply that plugs into the main power source (100 – 240V ~, 50 / 60 Hz). Only a Natus-approved power supply specifically for the neoBLUE cozy device can be used (Natus P/N 600157). A holder for the power supply is provided for attachment to the side of a bassinet or railing.
Page 6
Ambient Operating Temperature DC Voltage Authorized European Representative Manufacture Date XXXX Manufacturer Natus WEEE Directive (Waste from Electrical and Electronic Equipment Directive) Symbol – Product should not be disposed of in normal waste Hot Surface neoBLUE® cozy Service Manual P/N 051915 Rev. D...
CHAPTER 2 OUTINE AINTENANCE ROCEDURES This chapter describes routine maintenance procedures for the neoBLUE cozy device, referred to as the UUT (Unit Under Test) in this chapter: 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.
2.1.2 Cleaning the Filter 2.1.2 Cleaning the Filter The filter housing is located at the flat end of the UUT and held in place magnetically. Locate The filter housing is located at the flat end of the UUT and held in place magnetically. Locate the hole on the standoff, indicated in Figure 1.
Note: *If a different radiometer is used, please refer to the Conversion Chart in Appendix If the meter is not listed, please contact Natus Technical Service before adjusting light intensity. Use of a radiometer with a HOLD feature is necessary if the radiometer display cannot be read while the radiometer sensor is faced down.
Note: The UUT can conform to specifications with some components unlit. However, if a large number are unlit, the UUT may not meet minimum values. Light intensity may need to be increased if many components are unlit. Note: Increasing intensity will reduce LED life.
LED components. If steps 1-4 comply, replace the filter housing and return the UUT to service. If steps 1-4 do not comply, refer to Chapter 3, Troubleshooting the neoBLUE cozy light. Safety Testing The safety tests listed below meet the standards of, and should be performed in accordance with, IEC 60601-1, Amendment 1, Amendment 2, and UL 60601-1, for instruments as Class 2 and TYPE BF and ANSI/NFPA Standard 99.
Page 12
Maximum Current Limits are listed below for each test and standard. TABLE 2.1 Power Cord Ground Integrity 100 milliohms or less TABLE 2.2 Earth Leakage Current AC Line Cord UL 2601-1 ANSI/NFPA Line Cord Neutral Cord IEC 60601-1 Polarity Normal Closed Closed 500 µA...
Excess noise When opening the neoBLUE cozy to examine the LED Panel, follow the procedures described in chapter 2, Routine Maintenance Procedures and chapter 4, Repair Procedures. The following illustration is provided to help the Biomedical Equipment Technician locate major measurement points.
Page 14
If the voltage is still LIGHT DOES NOT incorrect, replace the power supply. Contact APPEAR WHEN DEVICE Natus Technical Service or authorized IS TURNED ON service provider. Plug power cord in, exercising caution due to live circuit (12V DC, up to 5.4A). Check...
Page 15
Air vents are If the patient surface is above 40°C (104°F), blocked verify that the fan is functioning correctly. Operating conditions for the neoBLUE cozy Device not used light are 20 – 30°C (68 - 86°F). Verify that within specified...
Page 16
READS BELOW 30 µW/cm Light intensity needs to be Adjust light intensity per Section 2.2.2. adjusted The neoBLUE cozy mattress and disposable Natus approved are specially designed to transmit the mattress / greatest intensity possible. Use with disposable cover alternate materials will decrease the efficacy not used of the device.
Page 17
LED short or open If the device does not produce enough light, ONE OR MORE LED STRINGS GO OUT; replace the LED light panel. Contact Natus CANNOT ATTAIN Technical Service or authorized service APPROPRIATE provider.
EPAIR ROCEDURES This section presents procedures for repairing the neoBLUE cozy light, referred to as the UUR (Unit Under Repair) in this chapter. 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.
The plastic cover is removed by gently pulling it up from the base. Use caution; the cover may fit tightly onto the enclosure. If you are replacing the plastic cover, obtain the replacement and reverse the previous steps. During replacement, take care to place the cover over the foam cushioning strips. Verify that the foam strips are properly adhered to the base.
CAUTION: Do not grasp the LED components to remove the LED PCB from the light enclosure. Pull up from the edges of the PCB, starting from the end under the fan. If you are replacing the LED PCB, obtain the replacement and place into enclosure. Reconnect connectors to JP1, JP2, JP3, and JP4 and secure the ferrite with a new cable tie.
About the Device 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.
Spare Parts List Spare Parts List ITEM PART DESCRIPTION NUMBER 001092 PLASTIC COVER 030755 MATTRESS (NOT SHOWN) 040875 FILTER HOUSING 030775 FILTER 040912 REPLACEMENT LED PCB 040874 MATTRESS (BOX OF 2) (NOT SHOWN) 600165 ROCKER SWITCH 600157 POWER SUPPLY (NOT SHOWN) 800248 SCREW, 18-8 SS PAN HEAD SCREW, M4, 8MM 800247...
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 <...
(typically on an annual basis). Checking intensity before each use will confirm the “dosage” of light being delivered. The neoBLUE cozy LED Phototherapy system can be adjusted to a greater intensity, delivering a higher dosage treatment. Please refer to the Section 2.2.2, Adjusting Light Intensity.