natus neoBLUE User manual

Service Manual

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, neoBLUE and Bili-Meter are registered trademarks of Natus Medical Incorporated.
BiliBlanket is a registered trademark of GE Healthcare.
Joey is a registered trademark of Philips Healthcare.
© 2015 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 [phone]
Fax [phone]
Technical Service [phone]
Technical Service Fax [phone]
E-mail: [e-mail]
Customer Service [phone]
Customer Service Fax [phone]
E-mail: [e-mail]
International Support - Please contact your local Distributor.
Distributor locations can be found at www.natus.com
EU Representative
Natus Europe GmbH
Robert-Koch-Str. 1
82152 Planegg
Germany
Phototherapy System and Device: Patent Application Pending 10/265,9

Table of Contents
List of Figures 2
Chapter 1 Introduction 3
1.1 About this manual 3
1.2 Product description 5
1.3 Pictorial introduction to the neoBLUE system 5
1.4 Before you start 11
1.5 Contacting Natus Technical Support 12
Chapter 2 Routine Maintenance Procedures 13
2.1 Cleaning 14
2.2 Safety testing 15
2.3 Performance Verification 16
2.4 Adjusting light intensity 19
Chapter 3 Troubleshooting Guide 20
3.1 Troubleshooting the neoBLUE light 20
3.2 Troubleshooting the LED light current assembly 23
Chapter 4 Repair Procedures 26
4.1 Removing the lens 27
4.2 Removing the LED light panel 28
4.3 Removing components from the enclosure 29
Chapter 5 Parts and Specifications 32
5.1 How to order parts 32
5.2 Parts in context 32
5.3 Parts list 35
5.4 Illustrations of major parts 37
5.5 Accessory pack 39
5.6 Specifications 40
Chapter 6 Measuring the neoBLUE light with a radiometer 41
Chapter 7 Electromagnetic Specifications 42
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Chapter 1 Introduction
List of Figures
Figure 1-1 External, front view 6
Figure 1-2 External, rear view 6
Figure 1-3 Internal, view from top 8
Figure 1-4 Power supply 9
Figure 1-5 LED light current assembly 10
Figure 1-6 Block diagram 11
Figure 2-1 Locating the two filters on backside of enclosure 14
Figure 2-2 Measuring distance 18
Figure 2-3 Adjusting the potentiometers 19
Figure 4-1 Removing the lens 28
Figure 4-2 Removing the LED light panel 29
Figure 5-1 Enclosure and its attachments 33
Figure 5-2 Enclosure and its attachments 34
Figure 5-3 LED light panel (item # 1) 37
Figure 5-4 Enclosure (item # 2) 38
Figure 5-5 LED light current assembly (item # 3) 38
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Chapter 1 Introduction
In this chapter:
1.1 About this manual
1.2 Product description
1.3 Pictorial introduction to the neoBLUE system
1.4 Before you start
1.5 Contacting Natus Technical Support
1.1 About this manual
1.1.1 Overview
This manual contains information needed for servicing the neoBLUE Phototherapy System.
•Description of the product and overview illustrations (Chapter 1)
•Maintenance procedures (Chapter 2)
•Troubleshooting guide (Chapter 3)
•Repair procedures (Chapter 4)
•Parts and ordering information. (Chapter 5)
•Measuring the neoBLUE light with a radiometer (Chapter 6)
•Electromagnetic Specifications (Chapter 7)
1.1.2 Intended users
This service manual is written for qualified biomedical technicians. It describes service tasks which could
lead to injury, or which could damage the device, if attempted by a person without the requisite skills.
1.1.3 Manual conventions
Precautionary information is emphasized by being labeled as warning, caution or important. Other
explanatory information is highlighted with the word Note.
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Chapter 1 Introduction
Type of information
Usage
WARNING
Identifies conditions or practices that may result in injury or
death to the patient and/or user. Warnings are boxed and
preceded by a hazard symbol.
CAUTION:
Precedes an action that may result in damage to or
malfunction of the device.
Important!
An instruction provided to help ensure correct clinical results
and provide quality assurance to the phototherapy
procedures.
Note:
Background information provided to clarify a particular step
or procedure. Information in this category is not considered
precautionary.
Throughout the manual, when parts are referred to in figures or in the text, the Item Number from the
Parts List (Chapter 5) is used to identify the part.
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1.2 Product description
The neoBLUE®LED Phototherapy System consists of two products – the neoBLUE Phototherapy light
source (light) and the neoBLUE Phototherapy Roll Stand (roll stand). These components provide 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.
Blue LEDs emit light in the range of 400 – 550 nm (peak wavelength 450-475 nm). There are two light
intensity settings, high and low. The light output was factory calibrated with the neoBLUE®Radiometer to
provide an initial intensity of 35 µW/cm2/nm at the high setting and 15 µW/cm2/nm at the low setting at a
distance of 12 inches (30.5 cm) from the light enclosure to the baby. The light output can also be adjusted
using the two potentiometers (located on the side of the light enclosure) to accommodate different
distances.
WARNING Eye Protection: Do not look directly into the LEDs. Some
people are sensitive to blue light in the environment. Amber
safety glasses shield sensitive eyes, minimizing the effects of
the blue light.
LEDs have minimal light output degradation over their lifetime with proper use. Nevertheless, the user
can adjust the output of the LEDs for any degradation using the two potentiometers. Life testing has
shown neoBLUE LEDs can emit high intensity phototherapy for over 40,000 hours. Actual results may
vary based on environmental factors and adjustments to the potentiometers.
The roll stand is designed to hold 8 lbs of weight 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.
The light is mains-power operated. The power cord plugs into a receptacle at the power inlet at the back
of the light enclosure. A power cord strain relief bracket is provided to hold the power cord in place.
1.3 Pictorial introduction to the neoBLUE system
This section is meant to acquaint you with the various views of the neoBLUE light that you will see in the
course of troubleshooting and repairing it. The item numbers and names used in the Parts List (see
Chapter 5) are used throughout the book whenever parts are discussed.
These pictures show the front and rear views of the light enclosure, and internal views showing where the
major components are located and some details. Also included is a block diagram.
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Chapter 1 Introduction
FIGURE 1-1 EXTERNAL,FRONT VIEW
Item
Description
Notes
2
Enclosure
8
Light intensity rocker switch
Sets intensity to high or low
9
Target light rocker switch
Controls red target light; momentary action
33
On/standby switch
Lights up when device is on
FIGURE 1-2 EXTERNAL,REAR VIEW
8
33
9
2
12
7
29
6
12
34
30
2
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Item
Description
Notes
2
Enclosure
6
Lens
7
AC power entry module
Includes fuses
12
Enclosure fan filter assembly
Consists of a cover, filter, and backplate
29
Thumbscrew
For attaching enclosure to roll stand
30
Locating post screw
Slotted
34
Timer
Counts hours device is on
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Chapter 1 Introduction
FIGURE 1-3 INTERNAL,VIEW FROM TOP
Item
Description
Notes
1
LED light panel
4
LED light current assembly
5
Power supply
6
Lens
7
AC power entry module
Includes fuses
8
Light intensity rocker switch
For selecting intensity level
9
Target light rocker switch
Indicates center of treatment area
11
Vent Guard
A
Mounting plate
Mounts light to roll stand
33
On/standby switch
Lights up when device is on
34
Timer
Counts the hours the device is on
8
33
9
A
11
34
4
6
5
1
7
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FIGURE 1-4 POWER SUPPLY
s
Item
Description
A
24 volt ground Pins 5-8
B
24 volts + Pins 1-4
C
AC inlet
C
B
A
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Chapter 1 Introduction
FIGURE 1-5 LED LIGHT CURRENT ASSEMBLY
Item
Description
A
LED light panel header, J8
B
Main power, fan header, J2
C
Front panel switch header, J3
D
Light intensity adjustment potentiometers
E
On/standby header, J4
F
Timer power header, J5
G
Fan power header, J6
H
Timer reset header, J7
H
E
F
D
G
C
B
A
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The block diagram, Figure 1-6, lays out the electrical connections.
FIGURE 1-6 BLOCK DIAGRAM
1.4 Before you start
WARNING Observe Electrostatic Discharge (ESD) precautions when
handling, adjusting, or performing any procedure with the
device internal components.
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Chapter 1 Introduction
1.5 Contacting Natus Technical Support
Should you encounter situations that are not covered by this Service Manual, contact a Natus Technical
Support representative.
Please have your Natus device model and serial number available when calling Technical Support.
Natus Medical Incorporated
5900 First Avenue South
Seattle, WA 98108 USA
Telephone [phone]
Fax [phone]
Technical Service [phone]
Technical Service Fax [phone]
E-mail [e-mail]
Customer Service [phone]
Customer Service Fax [phone]
E-mail [e-mail]
International Support- Please contact your local Distributor
Distributor locations can be found at www.natus.com
EU Representative
Natus Europe GmbH
Robert-Koch-Str. 1
82152 Planegg
Germany
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Chapter 2 Routine Maintenance Procedures
In this chapter:
2.1 Cleaning
2.2 Safety testing
2.3 Performance Verification
2.4 Adjusting light intensity
This chapter includes procedures for routine maintenance of the neoBLUE light, hereafter called the Unit
Under Test (UUT). 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 UUT at the institution.
• Foreign material or liquid has been deposited on the UUT.
• UUT has been visually damaged or subjected to mechanical shock (e.g., being dropped).
• UUT has been submitted for maintenance or scheduled performance verification.
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Chapter 2 Routine Maintenance Procedures
2.1 Cleaning
Cleaning the UUT incorporates two different tasks:
• Cleaning the light enclosure and accessories (Section 2.1.1)
• Cleaning the light enclosure air filters (Section 2.1.2)
WARNING Disconnect UUT from AC power before cleaning.
WARNING Biohazard. Until UUT is disinfected per institutional
requirements, gloves and other appropriate safeguards
must be employed.
CAUTION: Do not immerse the UUT or its accessories in liquid, or clean with caustic or abrasive
cleaners. Do not spray or pour any liquid on the UUT enclosure.
2.1.1 Cleaning the light enclosure and accessories
Clean the UUT enclosure using a cloth dampened with Germiocide™ or an equivalent product. Wipe the
exterior plastic surfaces lightly. Do not allow any liquid to penetrate the power connector, switches, fans,
connectors, or openings on the enclosure.
2.1.2 Cleaning the light enclosure air filters
The air filters should be cleaned at least every 30 days to prevent possible instrument overheating.
1 Remove the covers from the enclosure fan filter assemblies, shown below in Figure 2-1.
2 Inspect filters for damage. If damaged, they must be replaced.
1 Clean the filter by holding it under warm running water to clean away dust and other foreign materials.
FIGURE 2-1 LOCATING THE TWO FILTERS ON BACKSIDE OF ENCLOSURE
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4 Place the filter in a clean environment and allow it to air dry. The process can be expedited by having
extra filters available for immediate replacement.
5 Return a dry filter to the fan assembly and press the filter cover firmly into place.
2.2 Safety testing
The safety tests meet the standards of, and are performed in accordance with, IEC 60601-1, for
instruments as Class 1 and TYPE BF.
Applicable tests for these standards are listed below. Technicians must be familiar with the standards
applicable to the technician’s institution and country. Test equipment and its application must comply with
the applicable standard in:
• Table 2-1 Ground Integrity
• Table 2-2 Earth leakage current
• Table 2-3 Enclosure leakage current
TABLE 2-1 GROUND INTEGRITY
100 milliohms or less
TABLE 2-2 EARTH LEAKAGE CURRENT
AC
Polarity
Line cord Neutral cord IEC 60601-1
Normal
Closed
Closed
500 µA
Reversed
Closed
Closed
500 µA
Normal
Open
Closed
1000 µA
Normal
Closed
Open
1000 µA
TABLE 2-3 ENCLOSURE LEAKAGE CURRENT
AC line cord
polarity
AC line cord
neutral
conductor
AC line cord
ground
conductor
IEC 60601-1
Normal
Closed
Closed
100 µA
Normal
Closed
Open
500 µA
Normal
Open
Closed
100 µA
Reversed
Closed
Open
500 µA
Reversed
Open
Closed
500 µA
Reversed
Closed
Open
500 µA
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Chapter 2 Routine Maintenance Procedures
2.3 Performance Verification
This section discusses the tests used to verify UUT performance
• Verifying general performance (Section 2.3.1)
• Checking the light intensity (Section 2.3.2)
All tests can be conducted without removing the UUT enclosure. If the UUT 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.
TABLE 2-4 EQUIPMENT
Tools and test equipment
Type
Screwdriver
Phillips, medium
Radiometer
neoBLUE Radiometer or equivalent (see Note below)
Potentiometer adjustment tool
GC Electronics 8608 or small flat head screwdriver
Allen wrench
5/16” 90 degree or equivalent
Safety glasses
Amber
Work pad
Any non-abrasive non-static surface
Note: If a different radiometer is used, please refer to the Conversion Chart in chapter 6.If the
meter is not listed, please contact Natus Technical Service before adjusting light intensity..
2.3.1 Verifying general performance
1 Turn off the Illuminated On/Standby switch and disconnect the AC power cord.
2 Remove the UUT from its roll stand by removing the thumbscrews, seen in Figure 1-2 on page 6.
3 Place the UUT on the work pad so the diffuser/LED light panel can be examined. Verify that the air
vents, Figure 2-1, are not blocked.
4 Connect the AC power cord to the UUT and to an AC receptacle.
WARNING It is strongly recommended the amber safety glasses be worn
at this time. Some people are affected by the blue color of the
light source. The technician should notify others in the
immediate area of this fact.
5 Place the light intensity rocker switch in the LOW position. Figure 1-1 on page 6 shows the location of
the rocker switches.
6 Turn on the lighted On/Standby Switch.
7 Verify that the enclosure fans are running.
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8 Confirm that the LED light panel lights are on and operating properly.
• Confirm the presence of both blue and yellow LEDs lighted in rows.
• Examine panel geometry for uniform light spacing and unlighted LEDs.
Note: The UUT can conform to specifications with some LEDs not lighted. However, if a large
number of LEDs are not lighted it may prevent the UUT from meeting minimum values required
during testing. If enough LEDs are missing the LED intensity adjustment may need to be
adjusted higher than necessary, which would reduce panel life.
• Press the target light rocker switch and verify that a diamond shaped group of RED LEDs is
lighted in the center of the LED light panel. The light must extinguish when the rocker switch is
released.
9 Verify that the Illuminated On/standby switch lights up.
10 Verify the timer is operating. The decimal point should be flashing if the device is on and not flashing
when the device is off. Turn off the UUT by turning off the Illuminated On/standby switch.
11 Check the light intensity. (See below.)
2.3.2 Checking the light intensity
Important! Initial intensity measurements were factory calibrated with the neoBLUE®Radiometer and
were based on the patient being 12 inches (30.5 cm) from the light panel diffuser of the UUT. The
light output can also be adjusted using the two potentiometers on the device (Section 2.4 Adjusting
Light Intensity) to accommodate different distances. Adjusting the UUT light intensity higher will
decrease expected LED light panel life.
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. Please refer to the
Conversion Chart in chapter 6 for information on other meters.
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Chapter 2 Routine Maintenance Procedures
FIGURE 2-2 MEASURING DISTANCE
Item
Description
Notes
6
Lens
8
Light intensity rocker switch
Sets intensity to high or low
9
Target light rocker switch
Controls red target light; momentary action
33
On/standby switch
Lights up when device is on
A
Radiometer
B
Distance
1 Determine the distance (B), which corresponds to how far the LED light panel will be from the patient
during therapy.
Important! The light intensity was factory calibrated with the neoBLUE®Radiometer and was based off
the distance (B) of 12 inches (30.5 cm).
2 Position the stand to suspend the light panel over the work pad.
3 Place the radiometer on the work pad under the light panel. The distance (B) should be measured from
the work pad surface to the bottom of the lens (6) as shown in Figure 2-2.
4 Check the intensity on the HIGH setting:
• Place the light intensity rocker switch (8) in the HIGH position.
• Turn on the illuminated On/standby switch. Verify that the enclosure fan is running and that the
LED light panel lights up.
• Power on the radiometer and place it in the approximate center of the work surface below the
UUT.
• After a stable reading is attained the radiometer should be moved as necessary to establish a
peak light reading. This should be in the approximate center of the area beneath the UUT
diffuser.
A
6
8
33
B
9
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