neoBLUE LED Phototherapy System Service Manual Rev C

Caution: Federal Law (U.S.) restricts this device to sale or use by or on the order of a physician (or properly licensed practitioner). neoBLUE and Bili-meter are registered trademarks of Natus Medical Inc. Biliblanket is a registered trademark of Ohmeda Medical.

© 2008 Natus Medical, Inc. 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. Corporate Headquarters Natus Medical Inc. 1501 Industrial Road San Carlos, CA 94070 USA Telephone +1 (650) 802-0400 Fax +1 (650) 802-0401 Technical Service Technical Service Fax E-mail Customer Service Customer Service Fax E-mail

+1 (888) 496-2887 +1 (650) 802 8680 [email protected] +1 (888) 622 2427 +1 (650) 802 6620 [email protected]

International Support- Please contact your local Distributor Distributor locations can be found at www.natus.com

www.natus.com Phototherapy System and Device: Patent Application Pending 10/265,9

Table of Contents

List of Figures

5

Chapter 1 Introduction

6

1.1 About this manual 1.1.1 Overview 1.1.2 Intended users 1.1.3 Manual conventions 1.2 Product description 1.3 Pictorial introduction to the neoBLUE system 1.4 Before you start 1.5 Contacting Natus Technical Support

Chapter 2 Routine Maintenance Procedures 2.1 Cleaning 2.1.1 Cleaning the light enclosure and accessories 2.1.2 Cleaning the light enclosure air filters 2.2 Safety testing 2.3 Performance Verification 2.3.1 Verifying general performance 2.3.2 Checking the light intensity 2.4 Adjusting light intensity ®

neoBLUE LED Phototherapy System Service Manual PN 001320 Rev C

6 6 7 7 7 8 14 15

16 16 17 17 18 19 20 21 24

3

Chapter 3 Troubleshooting Guide

25

3.1 Troubleshooting the neoBLUE light 3.2 Troubleshooting the LED light current assembly

Chapter 4 Repair Procedures

25 29

31

4.1 Removing the lens 4.2 Removing the LED light panel 4.3 Removing components from the enclosure 4.3.1 Removing the enclosure fan 4.3.2 Removing the AC power entry module 4.3.3 Removing the switches 4.3.4 Removing the timer

32 34 35 36 37 37 38

Chapter 5 Parts and Specifications

39

5.1 How to order parts 5.2 Parts in context 5.3 Parts list 5.4 Illustrations of major parts 5.5 Accessory pack 5.6 Specifications

39 39 42 45 47 49

Chapter 6 Technical Note on Radiometers

51

Index

53

4

neoBLUE LED Phototherapy System Service Manual PN 001320 Rev C

List of Figures

Figure 1-1 External, front view Figure 1-2 External, rear view Figure 1-3 Internal, view from top Figure 1-4 Power supply Figure 1-5 LED light current assembly Figure 1-6 Block diagram Figure 2-1 Locating the filter Figure 2-2 Measuring distance Figure 2-3 Adjusting the potentiometers Figure 4-1 Removing the diffuser Figure 4-2 Removing the LED light panel Figure 5-2 Enclosure and its attachments Figure 5-3 LED light panel (item #1) Figure 5-4 Enclosure (item #2)

®

neoBLUE LED Phototherapy System Service Manual PN 001320 Rev C

9 10 11 12 13 14 17 22 24 33 34 41 45 46

5

Introduction

Chapter 1

In this chapter: 1.1 1.2 1.3 1.4 1.5

About this manual Product description Pictorial introduction to the neoBLUE system Before you start Contacting Natus Technical Support

1.1 About this manual 1.1.1 Overview This manual contains information needed for servicing the neoBLUE Phototherapy System. • • • • • • •

6

Description of the product and overview illustrations (0) Maintenance procedures (Chapter 2) Troubleshooting guide (Chapter 3) Repair procedures (Chapter 4) Parts and ordering information. (Chapter 5) Conversion chart for photometers of various brands. (Chapter 6) Index

neoBLUE LED Phototherapy System Service Manual PN 001320 Rev C

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.

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.

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 ®

neoBLUE LED Phototherapy System Service Manual PN 001320 Rev C

7

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 is optimized to provide an average intensity of 30-35 µW/cm2/nm at the high setting and 12-15 µW/cm2/nm at the low setting at 30 cm (12 inches) distance from the light enclosure. 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 technician can adjust the output of the LEDs using two potentiometers located on the side of the light enclosure. The light is expected to operate as specified at least 10,000 hours at the low setting, and at least 4,000 hours at the high setting. 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.

8

neoBLUE LED Phototherapy System Service Manual PN 001320 Rev C

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. FIGURE 1-1 EXTERNAL, FRONT VIEW 2

8 33

9

Item

Description

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

®

Notes

neoBLUE LED Phototherapy System Service Manual PN 001320 Rev C

9

FIGURE 1-2 EXTERNAL, REAR VIEW 12 7 29 12

2

30

34 6

Item

10

2

Description Enclosure

Notes

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

neoBLUE LED Phototherapy System Service Manual PN 001320 Rev C

FIGURE 1-3 INTERNAL, VIEW FROM TOP 8 33

9

4

A 5

11 7 34 6

1

Item 1

Description 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

®

Notes

neoBLUE LED Phototherapy System Service Manual PN 001320 Rev C

11

FIGURE 1-4 POWER SUPPLY

B A

C

s

Item

12

Description

A

24 volt ground Pins 5-8

B

24 volts + Pins 1-4

C

AC inlet

neoBLUE LED Phototherapy System Service Manual PN 001320 Rev C

FIGURE 1-5 LED LIGHT CURRENT ASSEMBLY E

F

H

B

D

C

G

Item

A

A

Description 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

®

neoBLUE LED Phototherapy System Service Manual PN 001320 Rev C

13

The block diagram, Figure 1-6, lays out the electrical connections. FIGURE 1-6 BLOCK DIAGRAM

1.4 Before you start WARNING

14

Observe Electrostatic Discharge (ESD) precautions when handling, adjusting, or performing any procedure with the device internal components.

neoBLUE LED Phototherapy System Service Manual PN 001320 Rev C

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 Inc. 1501 Industrial Road San Carlos, CA 94070 USA Telephone +1 (650) 802-0400 Fax +1 (650) 802-0401 Technical Service Technical Service Fax E-mail Customer Service Customer Service Fax E-mail

+1 (888) 496-2887 +1 (650) 802 8680 [email protected] +1 (888) 622 2427 +1 (650) 802 6620 [email protected]

International Support- Please contact your local Distributor Distributor locations can be found at www.natus.com

®

neoBLUE LED Phototherapy System Service Manual PN 001320 Rev C

15

Routine Maintenance Procedures

Chapter 2

In this chapter: 2.1 2.2 2.3 2.4

Cleaning Safety testing Performance Verification 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.

2.1 Cleaning Cleaning the UUT incorporates two different tasks:

• • 16

Cleaning the light enclosure and accessories (Section 2.1.1) Cleaning the light enclosure air filters (Section 2.1.2) neoBLUE LED Phototherapy System Service Manual PN 001320 Rev C

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.

FIGURE 2-1 LOCATING THE TWO FILTERS ON BACKSIDE OF ENCLOSURE

2

Inspect filters for damage. If damaged, they must be replaced.

®

neoBLUE LED Phototherapy System Service Manual PN 001320 Rev C

17

3

Clean the filter by holding it under warm running water to clean away dust and other foreign materials.

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, Amendment 1, Amendment 2,) and UL 2601, for instruments as Class 1 and TYPE BF and ANSI/NFPA Standard 99. 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 Normal

Line cord

Neutral cord

IEC 60601-1

UL 2601-1 ANSI/NFPA 99

Closed

Closed

500 µA

300 µA

Reversed

Closed

Closed

500 µA

300 µA

Normal

Open

Closed

1000 µA

500 µA

Normal

Closed

Open

1000 µA

500 µA

18

neoBLUE LED Phototherapy System Service Manual PN 001320 Rev C

TABLE 2-3 ENCLOSURE LEAKAGE CURRENT AC line cord polarity

AC line cord neutral conductor

AC line cord ground conductor

IEC 60601-1

UL 2601-1 ANSI/NFPA 99

Normal

Closed

Closed

100 µA

300 µA

Normal

Closed

Open

500 µA

300 µA

Normal

Open

Closed

100 µA

300 µA

Reversed

Closed

Open

500 µA

300 µA

Reversed

Open

Closed

500 µA

300 µA

Reversed

Closed

Open

500 µA

300 µA

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.

®

neoBLUE LED Phototherapy System Service Manual PN 001320 Rev C

19

TABLE 2-4 EQUIPMENT Tools and test equipment

Type

Screwdriver

Phillips, medium

Radiometer

neoBLUE Radiometer, Ohmeda BiliBlanket® Meter II 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/ photometer is used please refer to Technical Note on Radiometers on page 51. If the meter is not listed in the conversion chart, please contact Natus Technical Service before adjusting the LED light panel intensity.

2.3.1 Verifying general performance 1 2

Turn off the Illuminated On/Standby switch and disconnect the AC power cord. Remove the UUT from its roll stand by removing the thumbscrews, seen in Figure 1-2 on page 10.

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 9 shows the location of the rocker switches.

6

Turn on the lighted On/Standby Switch.

7

Verify that the enclosure fans are running.

20

neoBLUE LED Phototherapy System Service Manual PN 001320 Rev C