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GE Healthcare

Lullaby™
LED Phototherapy System
Maintenance and Service Manual

Maintenance and Service Manual


English
2054622-001
Rev E
© 2011 by General Electric Company.
All rights reserved.
Repair Policy and Procedures

CAUTION

The procedure described in this service manual should be performed by trained and
authorized personnel only.Maintenance should only be undertaken by a competent
individual who has general knowledge of and experience with devices of this nature. No
repair should ever be undertaken or attempted by anyone not having such qualifications.
Genuine replacement parts manufactured or sold by GE Healthcare must be used for all
repairs. Read completely through each step in every procedure; any exceptions may result
in failure to properly and safely complete the attempted procedure. After repair, test the
equipment to ascertain that it complies with the published specifications

Do not use malfunctioning equipment. If the unit is under warranty, contact GE Healthcare
technical support at the number given at back of the manual PRIOR to performing any
repair on the unit.

w
GE Healthcare has declared that this product confirms with the European Council Directive
93/42/EEC Medical Device Directive when it is used in accordance with the instructions
provided in the Maintenance and service Manual.

This symbol indicates that the waste of electrical and electronic equipment must not
be disposed as unsorted municipal waste and must be collected separately. Please
contact an authorized representative of the manufacturer for information concerning the
decommissioning of your equipment.

© 2011 General Electric Company

All rights reserved. General Electric Company reserves the right to make changes in
specifications and features shown herein, or discontinue the product described at any
time without notice or obligation. Contact your GE Representative for the most current
information. Lullaby is a trademark owned by Datex-Ohmeda, Inc. GE and GE Monogram
are trademarks of General Electric Company. All other company and product names
mentioned may be trademarks of the companies with which they are associated.

2 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


ПРЕДУПРЕЖДЕНИЕ

Това упътване за работа е налично само на английски език.

• Ако доставчикът на услугата на клиента изиска друг език, задължение на


(BG) клиента е да осигури превод.
• Не използвайте оборудването, преди да сте се консултирали и разбрали
упътването за работа.
• Неспазването на това предупреждение може да доведе до нараняване на
доставчика на услугата, оператора или пациентa в резултат на токов удар,
механична или друга опасност.

警告

本维修手册仅提供英文版本。

• 如果客户的维修服务人员需要非英文版本,则客户需自行提供翻译服务。
(ZH-CN) • 未详细阅读和完全理解本维修手册之前,不得进行维修。
• 忽略本警告可能对维修服务人员、操作人员或患者造成电击、机械伤害或其他形
式的伤害。

警告

本服務手冊僅提供英文版本。

• 倘若客戶的服務供應商需要英文以外之服務手冊,客戶有責任提供翻譯服務。
(ZH-HK) • 除非已參閱本服務手冊及明白其內容,否則切勿嘗試維修設備。
• 不遵從本警告或會令服務供應商、網絡供應商或病人受到觸電、機械性或其他的
危險。

警告

本維修手冊僅有英文版。

• 若客戶的維修廠商需要英文版以外的語言,應由客戶自行提供翻譯服務。
(ZH-TW) • 請勿試圖維修本設備,除非 您已查閱並瞭解本維修手冊。
• 若未留意本警告,可能導致維修廠商、操作員或病患因觸電、機械或其他危險而
受傷。

UPOZORENJE

Ovaj servisni priručnik dostupan je na engleskom jeziku.

• Ako davatelj usluge klijenta treba neki drugi jezik, klijent je dužan osigurati prijevod.
(HR)
• Ne pokušavajte servisirati opremu ako niste u potpunosti pročitali i razumjeli ovaj
servisni priručnik.
• Zanemarite li ovo upozorenje, može doći do ozljede davatelja usluge, operatera ili
pacijenta uslijed strujnog udara, mehaničkih ili drugih rizika.

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 3


VÝSTRAHA

Tento provozní návod existuje pouze v anglickém jazyce.

• V případě, že externí služba zákazníkům potřebuje návod v jiném jazyce, je zajištění


(CS)
překladu do odpovídajícího jazyka úkolem zákazníka.
• Nesnažte se o údržbu tohoto zařízení, aniž byste si přečetli tento provozní návod a
pochopili jeho obsah.
• V případě nedodržování této výstrahy může dojít k poranění pracovníka prodejního
servisu, obslužného personálu nebo pacientů vlivem elektrického proudu, respektive
vlivem mechanických či jiných rizik.

ADVARSEL
Denne servicemanual findes kun på engelsk.
• Hvis en kundes tekniker har brug for et andet sprog end engelsk, er det kundens
ansvar at sørge for oversættelse.
(DA) • Forsøg ikke at servicere udstyret uden at læse og forstå denne servicemanual.
• Manglende overholdelse af denne advarsel kan medføre skade på grund af elektrisk
stød, mekanisk eller anden fare for teknikeren, operatøren eller patienten.

WAARSCHUWING

Deze onderhoudshandleiding is enkel in het Engels verkrijgbaar.

• Als het onderhoudspersoneel een andere taal vereist, dan is de klant


(NL)
verantwoordelijk voor de vertaling ervan.
• Probeer de apparatuur niet te onderhouden alvorens deze onderhoudshandleiding
werd geraadpleegd en begrepen is.
• Indien deze waarschuwing niet wordt opgevolgd, zou het onderhoudspersoneel, de
operator of een patiënt gewond kunnen raken als gevolg van een elektrische schok,
mechanische of andere gevaren.

WARNING:

This service manual is available in English only.

• If a customer’s service provider requires a language other than English, it is the


(EN)
customer’s responsibility to provide translation services.
• Do not attempt to service the equipment unless this service manual has been
consulted and is understood.
• Failure to heed this warning may result in injury to the service provider, operator, or
patient from electric shock, mechanical hazards, or other hazards.

HOIATUS

See teenindusjuhend on saadaval ainult inglise keeles

• Kui klienditeeninduse osutaja nõuab juhendit inglise keelest erinevas keeles,


(ET)
vastutab klient tõlketeenuse osutamise eest.
• Ärge üritage seadmeid teenindada enne eelnevalt käesoleva teenindusjuhendiga
tutvumist ja sellest aru saamist.
• Käesoleva hoiatuse eiramine võib põhjustada teenuseosutaja, operaatori või
patsiendi vigastamist elektrilöögi, mehaanilise või muu ohu tagajärjel.

4 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


VAROITUS

Tämä huolto-ohje on saatavilla vain englanniksi.

• Jos asiakkaan huoltohenkilöstö vaatii muuta kuin englanninkielistä materiaalia,


(FI)
tarvittavan käännöksen hankkiminen on asiakkaan vastuulla.
• Älä yritä korjata laitteistoa ennen kuin olet varmasti lukenut ja ymmärtänyt tämän
huolto-ohjeen.
• Mikäli tätä varoitusta ei noudateta, seurauksena voi olla huoltohenkilöstön,
laitteiston käyttäjän tai potilaan vahingoittuminen sähköiskun, mekaanisen vian tai
muun vaaratilanteen vuoksi.

ATTENTION

Ce manuel d’installation et de maintenance est disponible uniquement en anglais.

• Si le technicien d’un client a besoin de ce manuel dans une langue autre que
(FR)
l’anglais, il incombe au client de le faire traduire.
• Ne pas tenter d’intervenir sur les équipements tant que ce manuel d’installation et
de maintenance n’a pas été consulté et compris.
• Le non-respect de cet avertissement peut entraîner chez le technicien, l’opérateur
ou le patient des blessures dues à des dangers électriques, mécaniques ou autres.

WARNUNG

Diese Serviceanleitung existiert nur in englischer Sprache.

• Falls ein fremder Kundendienst eine andere Sprache benötigt, ist es Aufgabe des
(DE)
Kunden für eine entsprechende Übersetzung zu sorgen.
• Versuchen Sie nicht diese Anlage zu warten, ohne diese Serviceanleitung gelesen
und verstanden zu haben.
• Wird diese Warnung nicht beachtet, so kann es zu Verletzungen des
Kundendiensttechnikers, des Bedieners oder des Patienten durch Stromschläge,
mechanische oder sonstige Gefahren kommen.

ΠΡΟΕΙΔΟΠΟΙΗΣΗ

Το παρόν εγχειρίδιο σέρβις διατίθεται μόνο στα αγγλικά.

• Εάν ο τεχνικός σέρβις ενός πελάτη απαιτεί το παρόν εγχειρίδιο σε γλώσσα εκτός
(EL)
των αγγλικών, αποτελεί ευθύνη του πελάτη να παρέχει τις υπηρεσίες μετάφρασης.
• Μην επιχειρήσετε την εκτέλεση εργασιών σέρβις στον εξοπλισμό αν δεν έχετε
συμβουλευτεί και κατανοήσει το παρόν εγχειρίδιο σέρβις.
• Αν δεν προσέξετε την προειδοποίηση αυτή, ενδέχεται να προκληθεί τραυματισμός
στον τεχνικό σέρβις, στο χειριστή ή στον ασθενή από ηλεκτροπληξία, μηχανικούς ή
άλλους κινδύνους.

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 5


FIGYELMEZTETÉS

Ezen karbantartási kézikönyv kizárólag angol nyelven érhető el.

• Ha a vevő szolgáltatója angoltól eltérő nyelvre tart igényt, akkor a vevő felelőssége
(HU)
a fordítás elkészíttetése.
• Ne próbálja elkezdeni használni a berendezést, amíg a karbantartási kézikönyvben
leírtakat nem értelmezték.
• Ezen figyelmeztetés figyelmen kívül hagyása a szolgáltató, működtető vagy a beteg
áramütés, mechanikai vagy egyéb veszélyhelyzet miatti sérülését eredményezheti.

AÐVÖRUN

Þessi þjónustuhandbók er aðeins fáanleg á ensku.

• Ef að þjónustuveitandi viðskiptamanns þarfnast annas tungumáls en ensku, er það


(IS)
skylda viðskiptamanns að skaffa tungumálaþjónustu.
• Reynið ekki að afgreiða tækið nema að þessi þjónustuhandbók hefur verið skoðuð
og skilin.
• Brot á sinna þessari aðvörun getur leitt til meiðsla á þjónustuveitanda, stjórnanda
eða sjúklings frá raflosti, vélrænu eða öðrum áhættum.

AVVERTENZA

Il presente manuale di manutenzione è disponibile soltanto in lingua inglese.

• Se un addetto alla manutenzione richiede il manuale in una lingua diversa, il cliente


(IT)
è tenuto a provvedere direttamente alla traduzione.
• Procedere alla manutenzione dell’apparecchiatura solo dopo aver consultato il
presente manuale ed averne compreso il contenuto.
• Il mancato rispetto della presente avvertenza potrebbe causare lesioni all’addetto
alla manutenzione, all’operatore o ai pazienti provocate da scosse elettriche, urti
meccanici o altri rischi.

このサービスマニュアルには英語版しかありません。
(JA) • サービスを担当される業者が英語以外の言語を要求される場合、翻訳作業はそ
の業者の責任で行うものとさせていただきます。
• このサービスマニュアルを熟読し理解せずに、装置のサービスを行わないでく
ださい。
• この警告に従わない場合、サービスを担当される方、操作員あるいは患者 さん
が、感電や機械的又はその他の危険により負傷する可能性があります。

6 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


경고

본 서비스 매뉴얼은 영어로만 이용하실 수 있습니다.

• 고객의 서비스 제공자가 영어 이외의 언어를 요구할 경우, 번역 서비스를


(KO)
제공하는 것은 고객의 책임입니다.
• 본 서비스 매뉴얼을 참조하여 숙지하지 않은 이상 해당 장비를 수리하려고
시도하지 마십시오.
• 본 경고 사항에 유의하지 않으면 전기 쇼크, 기계적 위험, 또는 기타 위험으로
인해 서비스 제공자, 사용자 또는 환자에게 부상을 입힐 수 있습니다.

BRĪDINĀJUMS

Šī apkopes rokasgrāmata ir pieejama tikai angļu valodā.

• Ja klienta apkopes sniedzējam nepieciešama informācija citā valodā, klienta


(LV)
pienākums ir nodrošināt tulkojumu.
• Neveiciet aprīkojuma apkopi bez apkopes rokasgrāmatas izlasīšanas un saprašanas.
• Šī brīdinājuma neievērošanas rezultātā var rasties elektriskās strāvas trieciena,
mehānisku vai citu faktoru izraisītu traumu risks apkopes sniedzējam, operatoram
vai pacientam.

ĮSPĖJIMAS

Šis eksploatavimo vadovas yra tik anglų kalba.

• Jei kliento paslaugų tiekėjas reikalauja vadovo kita kalba – ne anglų, suteikti vertimo
(LT)
paslaugas privalo klientas.
• Nemėginkite atlikti įrangos techninės priežiūros, jei neperskaitėte ar nesupratote šio
eksploatavimo vadovo.
• Jei nepaisysite šio įspėjimo, galimi paslaugų tiekėjo, operatoriaus ar paciento
sužalojimai dėl elektros šoko, mechaninių ar kitų pavojų.

ADVARSEL

Denne servicehåndboken finnes bare på engelsk.

• Hvis kundens serviceleverandør har bruk for et annet språk, er det kundens ansvar å
(NO)
sørge for oversettelse.
• Ikke forsøk å reparere utstyret uten at denne servicehåndboken er lest og forstått.
• Manglende hensyn til denne advarselen kan føre til at serviceleverandøren,
operatøren eller pasienten skades på grunn av elektrisk støt, mekaniske eller andre
farer.

OSTRZEŻENIE

Niniejszy podręcznik serwisowy dostępny jest jedynie w języku angielskim.

• Jeśli serwisant klienta wymaga języka innego niż angielski, zapewnienie usługi
(PL)
tłumaczenia jest obowiązkiem klienta.
• Nie próbować serwisować urządzenia bez zapoznania się z niniejszym
podręcznikiem serwisowym i zrozumienia go.
• Niezastosowanie się do tego ostrzeżenia może doprowadzić do obrażeń serwisanta,
operatora lub pacjenta w wyniku porażenia prądem elektrycznym, zagrożenia
mechanicznego bądź innego.

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 7


AVISO

Este manual de assistência técnica encontra-se disponível unicamente em inglês.

• Se outro serviço de assistência técnica solicitar a tradução deste manual, caberá ao


(PT-BR)
cliente fornecer os serviços de tradução.
• Não tente reparar o equipamento sem ter consultado e compreendido este manual
de assistência técnica.
• A não observância deste aviso pode ocasionar ferimentos no técnico, operador ou
paciente decorrentes de choques elétricos, mecânicos ou outros.

ATENÇÃO

Este manual de assistência técnica só se encontra disponível em inglês.

• Se qualquer outro serviço de assistência técnica solicitar este manual noutro


(PT-PT)
idioma, é da responsabilidade do cliente fornecer os serviços de tradução.
• Não tente reparar o equipamento sem ter consultado e compreendido este manual
de assistência técnica.
• O não cumprimento deste aviso pode colocar em perigo a segurança do técnico, do
operador ou do paciente devido a choques eléctricos, mecânicos ou outros.

ATENŢIE

Acest manual de service este disponibil doar în limba engleză.

• Dacă un furnizor de servicii pentru clienţi necesită o altă limbă decât cea engleză,
(RO)
este de datoria clientului să furnizeze o traducere.
• Nu încercaţi să reparaţi echipamentul decât ulterior consultării şi înţelegerii acestui
manual de service.
• Ignorarea acestui avertisment ar putea duce la rănirea depanatorului, operatorului
sau pacientului în urma pericolelor de electrocutare, mecanice sau de altă natură.

ОСТОРОЖНО!

Данное руководство по техническому обслуживанию представлено только на


английском языке.
(RU)
• Если сервисному персоналу клиента необходимо руководство не на английском,
а на каком-то другом языке, клиенту следует самостоятельно обеспечить
перевод.
• Перед техническим обслуживанием оборудования обязательно обратитесь к
данному руководству и поймите изложенные в нем сведения.
• Несоблюдение требований данного предупреждения может привести к тому,
что специалист по техобслуживанию, оператор или пациент получит удар
электрическим током, механическую травму или другое повреждение.

8 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


UPOZORENJE

Ovo servisno uputstvo je dostupno samo na engleskom jeziku.

• Ako klijentov serviser zahteva neki drugi jezik, klijent je dužan da obezbedi
(SR)
prevodilačke usluge.
• Ne pokušavajte da opravite uređaj ako niste pročitali i razumeli ovo servisno
uputstvo.
• Zanemarivanje ovog upozorenja može dovesti do povređivanja servisera, rukovaoca
ili pacijenta usled strujnog udara ili mehaničkih i drugih opasnosti.

UPOZORNENIE

Tento návod na obsluhu je k dispozícii len v angličtine.

• Ak zákazníkov poskytovateľ služieb vyžaduje iný jazyk ako angličtinu, poskytnutie


(SK)
prekladateľských služieb je zodpovednosťou zákazníka.
• Nepokúšajte sa o obsluhu zariadenia, kým si neprečítate návod na obluhu a
neporozumiete mu.
• Zanedbanie tohto upozornenia môže spôsobiť zranenie poskytovateľa služieb,
obsluhujúcej osoby alebo pacienta elektrickým prúdom, mechanické alebo iné
ohrozenie.

ATENCION

Este manual de servicio sólo existe en inglés.

• Si el encargado de mantenimiento de un cliente necesita un idioma que no sea el


(ES)
inglés, el cliente deberá encargarse de la traducción del manual.
• No se deberá dar servicio técnico al equipo, sin haber consultado y comprendido
este manual de servicio.
• La no observancia del presente aviso puede dar lugar a que el proveedor de
servicios, el operador o el paciente sufran lesiones provocadas por causas
eléctricas, mecánicas o de otra naturaleza.

VARNING

Den här servicehandboken finns bara tillgänglig på engelska.

• Om en kunds servicetekniker har behov av ett annat språk än engelska, ansvarar


(SV)
kunden för att tillhandahålla översättningstjänster.
• Försök inte utföra service på utrustningen om du inte har läst och förstår den här
servicehandboken.
• Om du inte tar hänsyn till den här varningen kan det resultera i skador på
serviceteknikern, operatören eller patienten till följd av elektriska stötar, mekaniska
faror eller andra faror.

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 9


OPOZORILO

Ta servisni priročnik je na voljo samo v angleškem jeziku.·

• Če ponudnik storitve stranke potrebuje priročnik v drugem jeziku, mora stranka


(SL)
zagotoviti prevod.·
• Ne poskušajte servisirati opreme, če tega priročnika niste v celoti prebrali in
razumeli.·
• Če tega opozorila ne upoštevate, se lahko zaradi električnega udara, mehanskih ali
drugih nevarnosti poškoduje ponudnik storitev, operater ali bolnik.

DİKKAT

Bu servis kılavuzunun sadece ingilizcesi mevcuttur.

• Eğer müşteri teknisyeni bu kılavuzu ingilizce dışında bir başka lisandan talep ederse,
(TR)
bunu tercüme ettirmek müşteriye düşer.
• Servis kılavuzunu okuyup anlamadan ekipmanlara müdahale etmeyiniz.
• Bu uyarıya uyulmaması, elektrik, mekanik veya diğer tehlikelerden dolayı teknisyen,
operatör veya hastanın yaralanmasına yol açabilir.

10 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


Table of Contents
About this Manual...........................................................................................................13
Chapter 1: Safety.............................................................................................................15
1.1 WARNING.........................................................................................................................................15
1.2 CAUTION............................................................................................................................................15

Chapter 2: Product Description....................................................................................17


2.1 Features................................................................................................................................................17
2.3 Controls, Indicators, Mechanical controls............................................................................18

Chapter 3: Installing and Setup....................................................................................21


3.1 Installing Instructions.....................................................................................................................21
3.2 Contents of Lullaby LED Phototherapy Packaging.........................................................21
3.3 Unpacking the box..........................................................................................................................22
3.4 Assembling the LED Phototherapy System.........................................................................22
3.5 Fixing the Arm and Lamp Enclosure.......................................................................................25
3.6 Attaching the Power Supply........................................................................................................27
3.7 Functional Description...................................................................................................................28
3.8 Using the Lamp enclosure without the Pedestal...............................................................30
3.9 Repacking the LED Phototherapy System for Local Transportation.......................31

Chapter 4: Maintenance and Service Checkout........................................................33


4.1 Repair Policy.......................................................................................................................................33
4.2 Required Tools and Personnel Protection Equipment.....................................................33
4.3 Service Checkout Procedure.......................................................................................................34
4.4 Maintenance......................................................................................................................................35

Chapter 5: Troubleshooting...........................................................................................37
Chapter 6: Replacement Procedures...........................................................................47
6.1 Preliminary Operation....................................................................................................................47
6.2 Replacing parts in Lamp Enclosure..........................................................................................48

Chapter 7: Illustrated Parts...........................................................................................61


7.1 Lamp Unit...........................................................................................................................................61
7.2 Pedestal................................................................................................................................................63
7.3 Base........................................................................................................................................................64
7.4 Torque Wrench..................................................................................................................................64
7.5 Power.....................................................................................................................................................65
7.6 Caster.....................................................................................................................................................66
7.7 Lamp Life Timer.................................................................................................................................66
11 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.
Table of Contents
7.8 Harness Assembly...................................................................................................................................67
7.9 Hardware Assembly...............................................................................................................................68
7.10 User Manuals.........................................................................................................................................68

Chapter 8: Product Label.....................................................................................................69


Chapter 9: System Electrical...............................................................................................71
Appendix A: Specifications..................................................................................................73
Appendix B: Technical Reference.......................................................................................75
B.1 Effective Surface Area..........................................................................................................................75
B.2 Service Maintenance.............................................................................................................................77
B.3 Part Replacement....................................................................................................................................77

Appendix C: Electromagnetic Compatibility (EMC)........................................................79


C.1 Electromagnetic Emission..................................................................................................................79
C.2 CE Marking Information.......................................................................................................................81
C.3 Recommendation...................................................................................................................................82

Warranty...............................................................................................................................83

12 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


About this Manual

Scope
This manual provides a comprehensive description of the components of Lullaby LED
Phototherapy System and its operation and maintenance details.

Intended Users
This device should only be operated by health care providers who are trained in its
operation and familiar with the risks of this type of device.

Purpose
The manual provides a complete guide on how to install, use and maintain the Lullaby LED
Phototherapy System. Detailed technical information has been enumerated for the benefit
of the user to facilitate correct and effective application of the device.

Symbol Definition
The following table describes the symbols and its inferences.
Symbol Description
This symbol denotes “Caution, read accompanying documents.” This

q
applies also to when the Caution symbol appears on an equipment
. label. It means additional information is found in the accompanying
documents.

WARNING A WARNING statement is used when the possibility of injury exists.

A General Warning statement is used to inform the users of the


equipment on possible risk or injury.

NOTE A NOTE provides additional information to clarify a point in the text.

Cover the patient’s eyes while administering phototherapy.

Over Temperature Cut-off Indicator

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 13


About this Manual

Symbol Description

Power OFF

Power ON

Low Irradiance

High Irradiance

Maintain 35 cm minimum distance between light source and infant

European Union Representative

Manufacturer—The symbol shall be accompanied by the name and


the address of the manufacturer.

WEEE Symbol

CE Mark

DC Current

Part number of Lullaby LED Phototherapy System

Serial Number of Lullaby LED Phototherapy System

Lamp life timer

Refer to instruction manual/booklet

Do not move the incubator with the device on it.

Do not cover the vent

14 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


Chapter 1: Safety

All phototherapy methods have possible risks, therefore it is important to know and
understand the safety measures to be followed before using the phototherapy device. The
precautions mentioned below are to prevent possible risk of injury to the patient or the
operator and ensure correct usage of the equipment.
Note: This service manual is available only in English.

1.1 WARNING
• No modification of this equipment is allowed. Do not modify this equipment
without authorization of the manufacturer. If this equipment is modified,
appropriate inspection and testing must be conducted to ensure continued safe
use of the equipment.
• Unplug the power cord from the mains before opening the device for service.
• Do not lean against the side of LED Phototherapy system as it may cause it to tip
over.
• This device is for professional use only.
• Hot surface : The lens surface on the lamp enclosure assembly could be as hot as
70 °C during operation. Do not touch the lens when the lamps are in ON condition.
• Do not place lamp unit directly under any heat source such as a Radiant Warmer.
• No repair should ever be taken by unqualified personnel.
• To avoid over heating, do not cover any of the vents.
• Do not use the Lullaby LED Phototherapy System in the presence of flammable
anesthetics or gases to prevent any possibility of explosion under these
conditions.
The Lullaby LED Phototherapy System, as with any other electrical equipment, must
be handled with care to avoid damage to the equipment. Follow the below mentioned
precautions with regard to the device.

1.2 CAUTION q
• Servicing of this product in accordance with the service manual should never be
undertaken without the proper tools, test equipment, and the most recent revision
of the service manual, which has been clearly and thoroughly understood.
• Detailed drawings and the procedures for more extensive repairs are included
herein solely for service personnel having proper knowledge, tools, and test
equipment, and for service representative specially trained by GE Healthcare.
• To ensure the proper operation and light intensity, replace the LED Lamp only with
GE Healthcare replacement lamps.
• Use only the SMPS and power cord provided with the device to power the device.
• Operator Safety: Users may experience headache, nausea or mild vertigo if
the user remains in the irradiated area for a prolonged period of time. Using the

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 15


Safety

Lullaby LED Phototherapy System in a well-lit area or wearing glasses with yellow
lenses can alleviate potential effects.
• Disconnect the power unit before removing the Lamp enclosure.
• Use only hospital grade grounded receptacles.

16 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


Chapter 2: Product Description

The Lullaby LED Phototherapy System is intended to treat infants suffering from neonatal
hyperbilirubinemia, commonly known as neonatal jaundice. This section describes, in brief, the
various parts of the Lullaby LED Phototherapy System.
NOTE: Before using this device read the safety information.

2.1 Features
The Lullaby LED Phototherapy System consists of the Lamp enclosure, Pedestal Assembly and
Base assembly.
Part Illustration Function
1.1 1. Lamp Enclosure: The Lamp enclosure has
2.1
2.2 10 LED lamps enclosed in a plastic housing,
2.3 which forms the light source. It consists of
two parts- the upper enclosure and the lower
1.2 1 2.4 enclosure. The lamp enclosure can be tilted to
2.5 approximately 90° from the horizontal position.
1.1 Air-vent: The air vents provide ventilation to
2.6 the device when it is in use.
2 1.2 Handle: Depression provided on either side
to help hold the Lamp enclosure.
2. Pedestal Assembly: The pedestal consists of
the following parts:
• Knobs: The knobs secure the Lamp
2.7 enclosure to the Arm (2.3). By removing
the knobs the Lamp enclosure can be
2.8
detached and used independently.
2.1 Tilt knob: This knob can be loosened to tilt
the lamp enclosure.
3 2.2 Securing Knob: The retaining knob secures
the lamp enclosure to the Arm (2.3).
2.3 Arm: The Arm is fixed to the pedestal and
supports the lamp enclosure.
3.1
2.4 Inner tube: This part supports the Arm (2.3).
The inner tube can be adjusted to vary the
height of the lamp enclosure.
2.5 Height Adjust Lock: This part secures the
Figure 2-1 : LED phototherapy System inner tube at the desired height.
2.6 Outer tube: This part is fixed to the Base.
2.7 SMPS Holder: This part is attached to the
outer tube to place the SMPS (DC power
supply).
2.8 SMPS with power cord: The power unit with
power cables to supply power to the unit.

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 17


Product Description

Part Illustration Function


1.1 2.1 3. Base Assembly: The base is designed to
2.2 provide stability at any height or angle of the
2.3 lamp enclosure.
3.1 Casters with brake: The swivel casters
1.2 1 2.4 add mobility to the device. The brakes
on each caster, when actuated, prevents
2.5
movement.
2.6 Note: To move the equipment hold the unit below
2 the height adjust lock.

2.7

2.8

3.1

2.3 Controls, Indicators, Mechanical controls


This section describes, in detail, the components of the Lullaby LED Phototherapy System.

2.3.1 Controls

DC Jack (Refer Figure 2-2): The device is powered


by a 24V SMPS. The power supply cable from the
SMPS is connected to the DC jack on the lamp
enclosure.
WARNING
1. The use of power cords and SMPS other than
those specified by the manufacturer might
affect the performance of the unit and could
result in damage to the unit.
Figure 2-2 : DC Jack 2. It may also create an unsafe operating
condition, exposing a user to electric shock.

18 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


Product Description

Power ON/OFF Switch (Refer 1 of Figure 2-3):


This switch turns ON and OFF the power supply to
3 the device.
WARNING
Disconnect the power cord to completely cut-off
the power supply to the device.
Irradiance Selection Switch (Refer 2 of Figure
2-3): The irradiance selection switch is used to
select light intensity-low or high irradiance.
2 1
Air Vent (Refer 3 of Figure 2-3): The air vents
helps to circulate the air inside the lamp enclosure
Figure 2-3 : Lamp enclosure
and maintain its temperature when in use.

WARNING
Ensure that the air vents are not covered or
obstructed when the unit is being used.

2.3.2 Indicators
Over Temperature Cut-Off Indicator (Refer
Figure 2-4): This indicator glows when the device
shuts down due to over temperature (exceeds
85°C) inside the lamp enclosure.
NOTE: In normal operating condition this indicator
is OFF.

Figure 2-4 : Over temperature cut-off


indicator

Lamp Life Timer (Refer Figure 2-5): The Lamp


life timer indicates the number of hours the LED
lamps have been used.
NOTE: GEHC recommends, replacing the lamp
after 50000 hours.

Figure 2-5 : Lamp life timer

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 19


Product Description

2.3.3 Mechanical Controls


Height Adjust Lock (Refer Figure 2.6): This part
secures the inner tube at the desired height. The
inner tube is released when the lock is turned
counterclockwise allowing the height of the lamp
enclosure to be adjusted.

WARNING
Always support the lamp enclosure with one hand
when releasing the lock to adjust the height.

Figure 2-6 : Height adjust lock


SMPS Holder (Refer Figure 2-7): The holder is
To DC Jack fixed to the outer tube to support the SMPS (power
supply unit).
SMPS (Refer to Figure 2-7): The power supply
SMPS unit is connected with power cables. The cable is
SMPS Holder connected to the DC jack, on the Lamp enclosure,
at one end and to the AC power source on the
other.

To AC Power source CAUTION


Wrap the excess cord around the SMPS holder to
avoid the cord from trailing when moving or using
Figure 2-7 : SMPS with power cables in the device.
SMPS holder
Base (Refer Figure 2-8): The base keeps the
device unit in a stable position.
Casters with position lock (Refer Figure 2-9):
The swivel centre casters offer easy mobility in
all directions. The casters can be kept in place by
locking it in position using the brake lever.
Figure 2-8 : Base Assembly WARNING
1. Always support the pedestal with one hand
while locking or unlocking the casters.
2. Ensure that the brakes on all four casters are
unlocked before moving the unit.

Figure 2-9 Caster with brake lever

20 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


Chapter 3: Installing and Setup

3.1 Installing Instructions


Lullaby LED Phototherapy System should be installed by qualified personnel. Follow the
instructions carefully to ensure proper mounting and safe operation.

WARNING:
Installation must be carried out by qualified service personnel. Before assembling the
Lullaby LED Phototherapy System and administering phototherapy, carefully read all
sections of this manual.

3.1.1 Required Tools and Personal Protective equipment (PPE)


S.No Description
1 Standard Service Tool Kit
2 Ohmeda Medical BiliBlanket Meter II
3 Safety shoes, safety gloves and safety glasses
4 Torque Wrench - range 2Nm - 8Nm

3.1.2 Installation Duration


The average time for installing and performing mandatory check out procedure for a
Lullaby LED Phototherapy System is 45 minutes.

3.2 Contents of Lullaby LED Phototherapy Packaging


Verify the following parts are included in the packaging box:

Description Quantity
Lamp enclosure 1
Outer tube assembly 1
Inner tube assembly 1
Base assembly 1
Lower Arm 1
Upper Arm 1
SMPS 1
SMPS Holder 1
Power Cord 1
Fastener Kit 1
Operation & Maintenance Manual 1
Maintenance & Service Manual 1

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 21


Installing and Setup

3.3 Unpacking the box


The system is shipped in one box. Check the contents of the box after opening, if any of the
components are missing contact your local customer care at the number provided at the
end of this document.

Top cover
Height lock
Outer tube
SMPS holder Inner tube
Upper & Lower arm
Base
SMPS
Foam
Lamp
enclosure
Box

Figure 3-1 : Unpacking the container


Follow the below instructions to unpack the box:
1. Remove the top cover and the rectangular protective cardboard piece from the box.
2. Lift the parts from the box and place it on a clean flat surface.
3. Remove the shrink wrap on the parts.
Preserve the packaging so that it can be used to repack when the LED Phototherapy
System when it is being transported locally.

WARNING
The LED Phototherapy system should not be subjected to outdoor transport, in the
assembled condition.

3.4 Assembling the LED Phototherapy System


The components have to be assembled as per instructions provided in the following
sections. The assembly is done from Base upwards.

22 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


Installing and Setup

3.4.1 Fixing the Pedestal Assembly to the Base


Product Illustration Instructions
Instructions to fit the outer tube
to the Base assembly
1. Place the base assembly on a flat
surface.
.
2. Tilt the base and insert the tube from
Brake below as shown in the Figure 3-3.
Caster 3. Align the holes of the outer tube to
that on the Base, fasten the M6 screws
by applying tightening torque of 8 Nm
Figure 3-2 : Base Assembly using torque wrench until the spring
washers bottoms out.
4. Place the Base upright.
5. Apply the caster brakes.
Outer Tube

Base

M6 Screws

Figure 3-3 : Fixing the Outer tube

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 23


Installing and Setup

Product Illustration Instructions


Height lock inner Instructions to fix the Inner tube
Height lock outer
into the Outer tube
Inner tube 6. Assemble the suspension spring
into the Outer tube, hold the Inner
tube assembly upright as shown in
Slide inner figure 3-4 and insert it into the Outer
M6 Flat washer tube along the orientation. Orient
M6 Screw the clearance provided in slide inner
Suspension spring to the weld line inside the outer tube
pedestal (See figure 3-5).
Outer tube 7. Place the Height lock on the threads
provided on the outer tube.
8. Adjust the height of the Inner tube.
9. Tighten the Height lock by turning it
SMPS clockwise. This will hold the tube in
holder place at the desired height,

Figure 3-4 :Fitting the Inner tube into the


Outer tube

Clearance in Slide
inner
Welded seam on
Outer tube
:

Figure 3-5 Orientation of the Outer tube

24 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


Installing and Setup

Product Illustration Instructions


Instructions to fix the SMPS holder on
Outer tube the Outer tube
SMPS holder
1. Align the holes in the holder to that
on the outer tube.
2. Fix the M4 screws. Tighten the
screws with the 2.5 mm hex keys
until the spring washers bottoms
M4 Screws out.
Instructions to dismantle the Pedestal
assembly
1. When dismantling the Inner tube
remove the Lamp enclosure and the
Figure 3-6 :Fixing the SMPS Holder Arm. (Do the reverse of procedures
in section 3.5 and 3.6)
2. Loosen the Height lock and reverse
the procedure of installing the Inner
tube.

3.5 Fixing the Arm and Lamp Enclosure


Product Illustration Instruction
The Arm is fixed to the top end of the
Inner tube. The Arm has two components,
M4
the lower arm and the upper arm that are
Screws
held together with two knobs.

Instructions to fix the Arm to the


Inner tube
Lower arm 1. Align the holes on top of the Inner
tube to the holes in the lower arm as
shown in Figure 3-7.
2. Fasten the two M4 screws by
applying tightening torque of 2 Nm
Inner using torque wrench.
tube
NOTE: Before fixing the upper arm, place
the Lamp enclosure on the horizontal
groove in the lower arm (Figure 3-8).

Figure 3-7 : Fixing the lower arm to the


pedestal

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 25


Installing and Setup

Product Illustration Instruction

Lamp
Instructions to fix the Lamp
enclosure enclosure on the Lower arm

The Lamp enclosure is a fully


Horizontal
assembled unit.
3. Hold the Lamp enclosure vertically
hinge
as shown in Figure 3-8 and place
Grooves
the horizontal hinge on the groove in
the lower arm.
Lower arm 4. Place the Upper arm on top of the
Lower arm. Fasten the knobs on the
Figure 3-8 : Fixing the Lamp enclosure upper arm. This secures the Lamp
enclosure on the pedestal. Refer
Knobs figure 3-9.
NOTE: For tilting the Lamp enclosure,
Upper arm refer to section 3.7.3 Tilting the Lamp
enclosure.

Figure 3-9 : Placing the Upper arm and


tightening the knobs

Instructions to dismantle the Arm and


Lamp enclosure
1. To remove the arm, unscrew the
knobs to open the upper arm.
2. Remove the Lamp enclosure.
3. Unscrew the Lower arm from the
Pedestal.

26 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


Installing and Setup

3.6 Attaching the Power Supply


Product Illustration Description
Instructions to attach the power cord
1. Place the SMPS in the SMPS holder.
2. Connect the DC plug of the SMPS cable into
the DC jack as shown in Figure 3-10.
3. Fix the power cord to the SMPS as shown in
Figure 3-11. Connect the other end of the
power cord to the mains supply.
DC Plug

DC Plug CAUTION
Ensure that the power cord is not in the way of
frequent movement to avoid accidental tripping.
Figure 3-10 : DC jack

SMPS

AC power cord
point

Figure 3-11 : SMPS unit

Note : After the installation of the device service check out procedure per section 4.3 of this
manual shall be performed.

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 27


Installing and Setup

3.7 Functional Description


The following section describes certain useful functions of the Lullaby LED Phototherapy
System.

3.7.1 Switching-ON the System


Product Illustration Description
Instructions to switch-ON the unit
1. Connect the power cables as
described in section 3.6.
2. Turn ON the Power ON/OFF
switch. (Figure 3-12)
Power 3. Select the irradiance level with
switch the Irradiance selection switch.
Irradiance The nominal output at high
Lamp hour Over temperature select switch intensity is: 45 µW/ cm2/nm
meter cut-off indicator and 22 µW/ cm2/nm at low
intensity setting.
4. The Overheat Indicator glows
when the temperature in the
Lamp enclosure rises above the
maximum limit of 85°C.
5. The Lamp Hour Meter displays
Figure 3-12 :Switches and Indicator
the number of hours the light
unit has been used.

CAUTION
There could be a reduction in
irradiance up to 30% at 50,000
hours. It is recommended to check
the irradiance of the lights after
50,000 hours of use.

3.7.2 Adjusting the height of the pedestal


Product Illustration Description
The height of the Pedestal can be adjusted to suit any
requirement.
Instructions to adjust the height of the Pedestal
1. Hold the inner tube of the pedestal with one hand and
loosen the Height lock by turning it anti-clockwise.
2. Move the inner tube upward to increase the height
and downward to reduce the height.
3. After adjusting to the desired height tighten the Height
lock by turning it clockwise.
Figure 3-13 :Height Lock

28 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


Installing and Setup

Product Illustration Description

WARNING
1. Ensure that the Height lock is tightened thoroughly.
2. Maintain the minimum distance of 35 cms between
the patient and the Lamp enclosure.

3.7.3 Tilting the Lamp Enclosure


Product Illustration Description
The Lamp enclosure can be tilted up to an
angle of 90°.
Instructions to tilt the Lamp enclosure
Tilt knob
1. Loosen the Tilt knob indicated in Figure
3-14 by turning it anti clockwise.
2. Tilt the Lamp enclosure about the hinge to
the desired angle, see Figure 3-15. Tighten
the knob to fix the Lamp enclosure in the
selected angle.

WARNING
1. Always support the Lamp enclosure with
one hand when loosening or tightening the
knob.
Figure 3-14 : Front knob
2. Ensure that the knob is tightened
thoroughly.

Figure 3-15 : Tilting the Lamp


enclosure at an angle

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 29


Installing and Setup

3.7.4 Moving the Unit


Product Illustration Description
The wheels at the base allows easy
mobility.
Instructions on moving the unit
1. Base: The base is designed to prevent
tipping when the Lamp enclosure is
placed at an angle or the pedestal
is extended to its maximum height.
The wheels on the base allows easy
manoeuvring of the light unit.
2. Swivel casters with brake: The
casters helps to move the unit in any
direction. The brake lever over each
caster, when applied keeps the unit
fixed in one place. The brake lever can
be applied by foot.

Figure 3-16 :Base assembly

WARNING
1. Always support the device with one
hand while applying the brakes on the
casters.
2. Ensure that the brakes on all casters
are unlocked before moving the unit.

3.8 Using the Lamp enclosure without the Pedestal


The Lamp enclosure can be separated from the Pedestal and used independently such as
when placing it over an incubator.

30 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


Installing and Setup

Product Illustration Description

Instructions to detach the Lamp


enclosure from the pedestal
1. Remove the power supply cord
from the DC jack.
2. Remove the upper arm (Refer to
instructions in section 3.5).
3. Hold Lamp enclosure, tilt and lift it
off from the arm.
4. The Lamp enclosure can now be
used safely over an incubator.
Attach the DC power supply cord
in the DC jack and insert the plug
to the main power supply, all
other functionality of the Lamp
enclosure remain the same.

WARNING

1. It is advisable not to move the


incubator when using the light unit
as mentioned above.
2. Ensure that the air vents are not
covered or obstructed when the
unit is being used.

3.9 Repacking the LED Phototherapy System for Local


Transportation
The unit is tall and has moveable parts and therefore should not be transported in
assembled condition. It is best to assemble the whole unit at the customer site but if it is not
feasible follow the below process for local transportation.
Product Illustration Description
Packing the Lamp enclosure
1. Dismantle the Lamp enclosure from
the pedestal. Refer to section 6.2.2 in
Chapter 6- Replacement Procedure.
2. Wrap it in bubble wrap and secure the
ends with a tape.
3. Handle the lamp unit with care to
ensure it does not get damaged during
transportation

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 31


Installing and Setup

Product Illustration Description


Packing the Arm
1. Remove the Lower arm from the
pedestal. Refer to section 6.2.10 in
Chapter 6- Replacement Procedure.
2. Secure the knobs on the dismantled
arm and place it with the packed Lamp
enclosure.

Moving the rest of the unit


1. The base and the pedestal assembly
can be shifted in the assembled
condition, if a suitable mode of
transport is available to accommodate
it.
2. Reduce the height of the inner pedestal
to the minimum.
3. Preferably place the unit in an upright
position when transporting and
provide support to avoid movement or
tipping.
4. Or place it horizontally and provide
suitable support at both the ends to
avoid scratches and to prevent it from
moving.

32 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


Chapter 4: Maintenance and Service Checkout
This chapter includes preventive maintenance procedures as well as checkout procedures
required after installation, repair, or corrective maintenance.

q CAUTION
Detailed information for more extensive repairs is included in this manual solely for the
convenience of users having proper knowledge, tools, and test equipment, and for service
representatives trained by GE Healthcare.

WARNING
Do not perform any checkout procedure with the patient under the unit. If the equipment
fails any of the checkout procedure it must be removed from use and replaced.

4.1 Repair Policy


Warranty repair and service should be performed by a GE Healthcare Service
Representative or at the GE Healthcare Service and Distribution Center. To contact a GE
Healthcare Service Representative, call the GE Healthcare Service Office listed on the rear
cover of this manual.
• Do not use malfunctioning equipment, including equipment that does not pass
the checkout procedure.
• Non-warranty repairs may be performed by a GE Healthcare Representative or
by a competent, trained person who has experience in repairing devices of this
nature.
• Refer to the list of service parts and for instructions on how to service the device
in this manual.
• After service, follow the checkout procedures before using the Lullaby LED
Phototherapy System.
4.2 Required Tools and Personnel Protection Equipment
S.No Description
1 Standard Service Tool Kit
2 Ohmeda Medical BiliBlanket Meter II
3 Antistatic Mat
4 Anti- Static Wrist Strap
5 Safety shoes, safety gloves and safety glasses
Torque Wrench - range 2Nm - 8Nm
6 Note: Available as orderable part (Part No. 2055914-001) or Feild Engineer can
use suitable tool from their tool kit.

q CAUTION
Always use the personnel protection equipment when installing, dismantling,

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 33


Maintenance and Service Checkout

4.3 Service Checkout Procedure


Perform this activity every time the unit has to be serviced.

4.3.1 Mechanical Checkout


1. Examine the power cord for obvious signs of damage. Replace the power cord if
damage is evident.
2. Check for worn out or defective parts.
3. Tighten any loose screws.
4. Examine the air vent for any obstruction and clear them, if any.
5. Check the tilting mechanism of the Lamp enclosure and ensure that it remains in the
selected angle when the knobs are tightened.
6. Check the height adjust function to ensure that the pedestal tube slides and stays in
place at the chosen height, when locked.
7. Check the casters and the brakes for proper functioning.
4.3.2 Controls Checkout
The electrical controls are mounted on the Lamp enclosure.
4.3.2.1 Power ON/OFF
Connect the power supply cable from the SMPS to the DC jack on the lamp enclosure. Turn
ON the Power ON/OFF switch. Check all the LED lamps are lit.
4.3.2.2 Light intensity check out procedure
To check the light intensity:
1. Place the device over the bassinet/bed. Adjust the distance between bassinet/bed to
35 cm from the lamp enclosure. Ensure that the lamp assembly is directly over the bed
and horizontal to the bed surface.
2. Let the device to stabilize for 15 minutes.
3. Use properly calibrated Ohmeda Medical Biliblanket Meter II to check irradiance level
of the unit by keeping approximately in line with the lamp unit center. The measured
irradiance shall be 45 µW/ cm2/nm ± 25%.
4. Select the Irradiance switch to low irradiance. Let the device to stabilize for 15 minutes.
The measured irradiance shall be 22 µW/ cm2/nm ± 25%.
5. Once the check is complete, turn the unit OFF. The unit is ready to use.

q CAUTION
It is important to check the electrical safety test and light intensity measurement procedure
to assure that the unit is functioning properly at the time of servicing.
4.3.2.3 Lamp Life Timer
The Lamp Life timer indicates the number of hours the lamp has been used.
1. Connect the power cord and turn ON the unit.
2. Check if the timer is ON. Check the Lamp life timer increments after 6 minutes to
ensure the counter working.

34 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


Maintenance and Service Checkout

4.4 Maintenance
The Lullaby LED Phototherapy System should be maintained in accordance with the
preventative maintenance procedures detailed in this manual. Service maintenance must
be performed by a technically competent individual.

4.4.1 Operator maintenance


This schedule lists the recommended times for regular maintenance. Always follow hospital
and local regulations for required frequency of regular maintenance.
4.4.1.1 Cleaning
For cleaning instructions , refer section 5.1 of the Lullaby LED Phototherapy System
Operation & Maintenance manual.
4.4.1.2 Every week
Clean and disinfect the Lullaby LED Phototherapy System as required, or before a new
patient is admitted.

4.4.2 Service maintenance


This schedule lists the minimum frequencies. Always follow hospital and local regulations
for required frequencies.
4.4.2.1 Annually
GE Healthcare does not recommend any specific preventive maintenance for this product.
However please follow local regulations or hospital guidelines for preventive maintenance.
The following section can be followed for electrical safety as a part of preventive
maintenance as applicable.
Earth Leakage Current (Standard EN 60601)
The earth leakage current should be less than 5 mA in Normal Condition and it should be
less than 10 mA in Single Fault Condition.
NOTE: The earth leakage current should never exceed the limit. The data should be
recorded in an equipment log. If the device is not functioning properly or fails any the above
test, the device has to be repaired.

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 35


Maintenance and Service Checkout
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36 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


Chapter 5: Troubleshooting

This chapter lists the possible LED Phototherapy System symptoms as well as the possible
causes and solutions. For any necessary part replacements or adjustments, follow the
instructions provided in Chapter 6. Always read all the warnings, cautions, notes, and
other information provided in “ Safety” section starting on page 15 before starting any
troubleshooting. The following flowcharts describe likely symptoms, their causes and
actions to be taken.
A - Damaged parts
B - Jammed Parts
C- Functionality Issues
A: Damaged Parts

A1- Upper enclosure of the Enclosure, Y


Replace with the Enclosure Assembly
Lam Lamp is damaged
Lamp upper, FRU No. 2053648-001

Y
A2- Lower enclosure of the Enclosure,
Remove the unit
Replace with the from service
Enclosure and
Assembly
Lamp is damaged contact GE-authorized
Lamp lower, and trained
FRU No. 2053645-001
service personnel.

A3- Heat sink, MCPCB, Lens,LED is Y Replace with the Heat sink, MCPCB,
damaged Lens,LED ,FRU No. 2053651-001

Y
A4-Driver Board is damaged Replace with Driver Board , FRU No.
2053653-001

A5-Pedestal assembly parts are Y


Replace with Pedestal Assembly, FRU
damaged No. 2053655-001

A6-Base assembly unit is damaged Y Replace with Base Assembly, FRU No.
2053657-001

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 37


Troubleshooting

A7-SMPS is damaged Y Replace with Power supply, FRU No.


2053659-001

A8-Power cord is damaged Y Order for country specific cord from the
kit

Y
A9-Caster is damaged Replace with Caster FRU No.2053662-
001

A10-Switches are broken Y


Replace the switches with Harness
assembly FRU No. 2054787-001

e
Y
A11-Plastic ring is damaged Replace the Plastic ring with Hardware
FRU No. 2053665-001

B: Jammed Parts

n
Y The knob may be over tightened-try
B1- Lamp enclosure cannot be tilted to release and tighten.

If the above does not solve the issue,


replace the knobs from the Hardware
FRU kit, No. 2053665-001

Y Check if the thread on the knob is


B1.1- Lamp enclosure does not damaged. If yes, replace the knobs from
remain at the selected angle the Hardware FRU kit, No. 2053665-001.

Check if the hinge is damaged or the


Upper enclosure around the hinge is
cracked or damaged. If yes, replace with
the Enclosure Assembly Lamp Upper, FRU
No. 2053648-001

38 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


Troubleshooting

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 39


Troubleshooting

C:Functionality Issues

C1- Lamp unit overheat indicator is Y Turn off the mains switch and
ON disconnect the power cord from the
outlet.

Ensure that the air vents on the light unit


are not obstructed.

Ensure the area around the equipment


is not congested and is well ventilated
by air conditioning or natural means.

Allow the unit to cool down.

Plug the power cord and turn the


mains switch ON.

C2- Blue LED light not illuminating Y Check if the Over temperature cut-off
indicator is glowing.

N Y

Check if the Lamp life timer is Refer Troubleshoot reference C1.


functioning and displaying the number
of hours.

N Y

Refer Troubleshoot reference Refer Troubleshoot reference


C3. C2.1 and C2.2.

40 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


Troubleshooting

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 41


Troubleshooting

42 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


Troubleshooting

C3-Lamp life timer is not functioning Y Check if the blue LED lamps are glowing

Dismantle the Lamp enclosure and remove the


upper cover.

N
Replace LED Driver to Lamp Hour Meter Check the LED Driver to Lamp Hour Meter
Assembly from FRU Harness Assembly Harness assembly continuity is available.
Kit 2054787-001

N
Check if the Over Temperature cut off red LED
is illuminating.

Replace the Hour Meter from the FRU Kit


2054784-001 Y

Refer Troubleshoot reference C1.

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 43


Troubleshooting

C4- Unit will not power ON Remove the DC Plug from the Unit and
measure the voltage and confirm that
the voltage is within 24V ± 1VDC.

Check if the AC power cord is inserted


N properly at both ends, Mains and in the
SMPS.

Insert the connections and redo Y


the check.

N Remove the AC plug and check


continuity of the terminals at both end.

Replace the power cord


Y

Remove the Upper Lamp enclosure and


N check if there is electrical continuity
between the LED Driver to switches
Harness assembly.

Replace LED Driver to Switches


Harness Assembly from the FRU Y
Kit 2054787-001

Replace the SMPS from the Power Supply


FRU kit 2053659-001.

44 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


Troubleshooting

Y Check if the blue LEDs on the right


C5- Irradiance control is not working
(Harness Assembly 1) and left (Harness
Assembly 2) side are working.Refer Fig 6-5.

Refer Troubleshoot reference C2. N


Y

Replace LED Driver to Switches N Visually check the LED Driver to


Harness Assembly from Harness Switches Harness assembly connection
Assembly FRU Kit 2054787-001 is fine.

Replace LED Driver to Switches N Check the continuity of Single Pole


Harness assembly from the Harness Switch in the LED Driver to Switches
assembly FRU kit no 2054787-001 Harness Assembly

Replace LED Driver (2053653-001).

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 45


Troubleshooting

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46 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


Chapter 6: Replacement Procedures

6.1 Preliminary Operation

WARNING
Before performing any replacement do the following:
1. Always use anti-static material and wear anti-static wrist strap.
2. It is recommended to use safety glasses, safety shoes and safety gloves before
servicing the equipment.
3. Unplug the power supply cord.
4. Set the caster brakes (except when the base or casters require replacement).

CAUTION
The procedures described in this chapter should be performed by trained and authorized
personnel only. Genuine replacement parts sold by GE Healthcare must be used for all
repairs. Read through each step in every procedure before starting, any replacements.
Instructions
1. If the Lamp enclosure is warm, wait for it to cool down before performing any repair.
2. Prepare the following equipment:
• Phillips Screwdriver capable of removing and tightening 4 mm and 6mm screws
(they are preferably torque adjusted)
• Flat blade screwdrivers

Description
Slot Head Screwdriver
Phillips Screw driver #1
Torque wrench - range 2Nm - 8Nm

• Hex Keys of sizes 2.5mm, 4mm and 8mm


3. Use safety materials to avoid any damages to the equipment.
4. Check that you have taken the necessary safety measures.
5. Confirm that the supply plug of the LED Phototherapy is not connected and there is no
electricity supply to the unit.

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 47


Replacement Procedure

6.2 Replacing parts in Lamp Enclosure


The procedure to disassemble each part in order to replace is described in the following
sections.

6.2.1 Removing the Upper Arm


1. Support the Lamp enclosure with one hand and unscrew and remove both the knobs.
2. Lift the Upper arm and place it aside.

Knobs

Upper arm

Figure 6-1 : Replacing the Upper arm cover


3. To reinstall the Upper arm, reverse the procedure.
6.2.2 Removing the Lamp enclosure upper cover
1. Follow step 1 and 2 in section 6.2.1.
2. Hold the Lamp enclosure on either side with both hands, tilt it upwards and lift it off the
Lower arm (Figure 6-2). Place it on a clean and flat surface.

Lamp enclosure

Horizontal hinge

Lower arm

Figure 6-2 : Removing the Lamp enclosure from the Lower arm

48 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


Replacement Procedure
3. The screws are located on the lower part of the Lamp enclosure, see Figure 6-3. Lift the
Lamp enclosure on its sides and hold it with one hand. Remove the screw caps using
the flat end of a screw driver.

Upper enclosure

Screw

Lower enclosure
Screw Cap

Figure 6-3 : Screw caps


4. Remove the five M4 screws and one M3 screw. Lower the enclosure on the flat surface.

M3 Screw
M4 Screw

Lower
enclosure

Figure 6-4 ; Removing the screws


5. Hold the upper cover of the Lamp enclosure on either side and pull it to separate it
from the lower cover and place it aside.
6. To install the upper cover, reverse the procedure.
NOTE: When installing ensure that the five M4 screws are tightened by applying 2 Nm
torque. The screw caps should be flushed with the surface as shown in the Figure 6-3.

6.2.3 Removing the Driver Board


1. Remove the upper cover of the Lamp enclosure as described in section 6.2.2 (Removing
the Lamp enclosure upper cover).
2. Detach the harness assembly connected to the Driver board.

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 49


Replacement Procedure

Switch and MCPCB harness Lamp life time harness

Heat sink assembly 2


Heat sink assembly 1 MCPCB
harness

Figure 6-5 The Driver board with Harness assembly


3. Using a Phillips screw driver remove the M3 screw and M3 Flat washer from the Driver
board.
M3 Screw

M3 Flat washer

Driver board

Figure 6-6 : Removing the Driver board


4. Lift the Driver board off the lower enclosure and place it aside.

50 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


Replacement Procedure
5. To reinstall the Driver board, reverse the above procedure.
NOTE: During installation ensure that the wires are routed through the slots provided on the
lower cover.

Figure 6-7 :Routing the wires

6.2.4 Removing the Heat sink


1. Follow the steps as described in section 6.2.2 (Removing the Lamp enclosure upper
cover) to remove the upper cover of the Lamp enclosure.
2. Detach the MCPCB harness from the Driver board.
3. Use a 2.5 mm hex keys to unscrew M4 Screw.

M4 Screw

Figure 6-8 :Removing the Heat sink


4. Remove the Heat sink from the lower cover. Follow the same procedure to remove the
other Heat sink.
5. Reverse the procedure to install the Heat sink. Orient the LED lamps in the recess
provided on the lower enclosure cover when installing.

CAUTION
While replacement, ensure the lens is properly fixed on to the Metal Clad PCB and there is
no damage observed on the lens surface.

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 51


Replacement Procedure

6.2.5 Replacing the lower cover of Lamp Enclosure


All the electronic controls are fixed to the lower enclosure, perform all the dismantling
procedures detailed in section 6.2.1 to 6.2.4.
1. Detach the switch harness and pull out the Switch rocker array.
2. Detach the harness to the Lamp life timer and pull it out and place it aside.

Switch rocker
Lamp hour timer

Figure 6-9 :Switch with harness


3. Replace the lower enclosure and install the parts removed from it. Follow the
procedures in section 6.2.1 to 6.2.4 in the reverse order. To fix the harness in the correct
sequence see section 6.2.11 and 6.2.12.
NOTE: Orient the switches as shown in Figure 6-10.

Figure 6-10 Position of the switches

6.2.6 Replacing the Outer tube of the Pedestal assembly


1. Remove the Lamp enclosure, follow steps 1 and 2 of section 6.2.2 (Removing the Lamp
enclosure upper cover).
2. Detach the Inner tube from the Outer tube. For details on the procedure to detach the
Inner tube, see section 6.2.7.

52 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


Replacement Procedure

3. Unscrew the SMPS holder on the Outer tube with the 2.5 mm hex keys and remove
the M4 Screw, M4 Spring washer, M4 Flat washer and keep it aside, as shown in Figure
6-11.

M4 Flat washer SMPS holder


M4 Spring washer
M4 Screw

Figure 6-11 : Removing the SMPS holder


4. Tilt the base making sure that the outer tube is suitably supported or rest it on the
ground.
5. Use the 4mm hex keys to unscrew the M6 screw and M6 flat washer from the Base.
Outer tube

Base

M6 Screw

Figure 6-12 : Replacing the Outer tube


6. Hold the base with one hand and pull out the Outer tube.
7. To install the Outer tube, ensure that the plastic ring is in flush with the Base and
follow the above procedure in reverse order. Apply tightening torque of 8 Nm to the M6
screws during installation.
8. Place the base unit upright on a flat surface and set the caster brakes. Fix the Inner
tube as described in section 6.2.7.
9. Fix the SMPS holder to the Outer tube.

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 53


Replacement Procedure

6.2.7 Replacing the Inner tube of the Pedestal assembly


1. Follow steps 1 and 2 of section 6.2.2. to disengage the Lamp enclosure. Remove the
lower arm. Refer to section 6.2.10 for details.
2. Actuate the caster brakes.
3. Hold the Inner tube with one hand and release the height lock by turning it
counterclockwise. Remove the height lock from the Inner tube and place it aside.
4. Pull the Inner tube & suspension spring from the Outer tube of the Pedestal assembly,
see Figure 6-13
Height lock inner
Height lock outer

Inner tube

Slide inner

M6 Flat washer

M6 Screw
Suspension spring
pedestal

Outer tube

SMPS holder

Figure 6-13 :Replacing the Inner tube


5. To install the inner tube, insert the Height lock inner and Height lock outer on the Inner
tube.

54 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


Replacement Procedure
6. Assemble the suspension spring into the Outer tube, hold the Inner tube assembly
upright and insert it into the Outer tube along the orientation as shown in figure 6-13.
Ensure that the clearance provided in slide inner is aligned with the weld line inside the
outer tube. Refer figure 6-14.

Clearance in Slide inner

Welded seam on Outer tube

Figure 6-14 : Orienting the Inner tube to the Outer tube


7. Place the Height lock on the threads on the Outer tube.
8. Adjust the height of the Inner tube.
9. Tighten the Height lock by turning it clockwise to hold the tube in place at the desired
height,
10. Fix the lower arm to the top end of the Inner tube. For details on fixing the lower arm,
see section 6.2.10.
6.2.8 Replacing the Base
1. Dismantle the Lamp enclosure (refer section 6.2.2) and Pedestal assembly (refer section
6.2.6 & 6.2.7).
2. Unscrew the casters from the Base using the 8 mm hex key and keep it aside.
3. Replace the Base and assemble the casters on the new Base. For details on replacing
the casters, see section 6.2.9.

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 55


Replacement Procedure
4. Assemble the Pedestal assembly as per section 6.2.6 and place the Lamp enclosure
into position.

Figure 6-15 : Fixing Base

6.2.9 Replacing the Casters


Note: Remove the Lamp enclosure from the Pedestal before attempting to change the
casters.
1. Tilt the Base and unscrew the bolt on the caster with a 8 mm hex key.

Base

Caster

M10 Screw

Figure 6-16 :Fixing the caster

2. Replace the caster and tighten the bolt using the 8mm hex key.
6.2.10 Replacing the Lower arm
1. Remove the upper arm cover as described in section 6.2.1 (Removing the Upper arm).
2. Remove the Lamp enclosure and keep it in a safe place.

56 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


Replacement Procedure
3. Remove the M4 cap screw and M4 flat washer to remove the lower arm from the inner
tube.
M4 Screw

Figure 6-17 : Lower arm


NOTE: During installation apply tightening torque of 2 Nm using torque wrench on the M4
cap screw.

6.2.11 Replacing Lamp Hour Timer


1. Follow the steps in section 6.2.1 (Removing the Upper arm ) and 6.2.2 (Removing the
Lamp enclosure upper cover).
2. Disconnect the Lamp hour timer harness from the Driver board and pull out the Lamp
hour timer from the lower enclosure.
3. Replace with a new FRU. Connect the red color harness to Pin 1 and black harness to
Pin 2.
4. Reverse step 1 to install.

Lamp hour timer

Pin 1
Pin 2
Figure 6-18 : Lamp hour timer

6.2.12 Replacing the Harness Assembly


Following steps enumerate the procedure to replace the Harness Assembly.

6.2.12.1 Replacing MCPCB harness


1. Follow the steps in section 6.2.1 (Removing the Upper arm ) and 6.2.2 (Removing the
Lamp enclosure upper cover) and 6.2.4 (Removing the Heat sink).

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 57


Replacement Procedure
2. Disconnect the harness from the MCPCB. Reconnect the new harness. The right side (
Group 1) harness is connected to the J2 connector of the Driver board and the left side
( Group 2) harness is connected to the J3 connector.
3. Reverse step 1 to install.

J2 J3
MCPCB
Harness

Figure 6-19 MCPCB harness and connectors

CAUTION
While replacement, ensure the lens is properly fixed on to the Metal Clad PCB and there is
no damage observed on the lens surface.

J5 J6
Pin 1

2 Pin
Pin 2 1 Pin

Pin 1 Pin 4
Pin 4 Pin 1
J2 J3

Figure 6-20 : Pin location on the Driver board

58 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


Replacement Procedure

6.2.12.2 Replacing Switch and LED harness


1. Follow the steps in section 6.2.1 (Removing the Upper arm ) and 6.2.2 (Removing the
Lamp enclosure upper cover).
2. Disconnect the harness connected to the switches and LED indicator from the Driver
board and pull out the switch panel from the lower enclosure.
3. Replace with a new switch panel and reconnect the harness to the Driver board.
4. Reverse step 1 to install.
NOTE: Orient the position of the switches in the right direction when installing the switch
panel.

Switch rocker

Figure 6-21 : Switch harness

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 59


Replacement Procedure
This page is left blank intentionally.

60 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


Chapter 7: Illustrated Parts

This section lists the orderable parts of the Phototherapy System. When placing an order
for a FRU (Field Replaceable Unit), mention the Service FRU Kit Number given in the table
below.
NOTE: Only the Service FRU kits can be ordered and not the individual sub parts of the kits.

7.1 Lamp Unit

Figure 7-1 : Parts of Light unit

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 61


Illustrated Parts

Service Part/
Service Part/Kit
FRU KIT Item # Part Description Qty
Description
Number
10 Enclosure, Lamp Lower 1
13 Screw cap 5
ENCLOSURE, LAMP
2053645-001 12 M4 Screw 5
LOWER FRU KIT
11 M4 Flat washer 5
14 M3X 6 CSK skt flat head Screw 1
1 Enclosure Assy , Lamp Upper 1
13 Screw cap 5
ENCLOSURE ASSY ,
2053648-001 12 M4 Screw 5
LAMP UPPER FRU KIT
11 M4 Flat washer 5
14 M3X 6 CSK skt flat head Screw 1
Heat Sink, MCPCB Assembly,
5 1
XPE
6 Label, Hot surface 1

Heat sink and MCPCB, 15 Lens, XPE 5


2053651-001
Lens, LED FRU KIT 16 Adaptor, Lens 5
2 M4 Screw 4
3 M4 Split LK Washer 4
4 M4 Flat washer 4
9 PWA, LED PT Driver 1
LED Driver Board FRU
2053653-001 7 M3 Screw 4
KIT
8 Flat Washer, M3 4

62 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


Illustrated Parts

7.2 Pedestal

Figure 7-2 : Parts of the pedestal


Service Part/
Service Part/Kit
FRU KIT Item # Part Description Qty
Description
Number
3 Assy Inner Tube 1
8 Assy Outer Tube 1
7 Suspension Spring Pedestal 1
2 Height Lock outer 1
4 Slide, Inner 1
PEDESTAL ASSY FRU 1 Height Lock Inner 1
2053655-001
KIT 6 M6X20 Socket HD Cap Screw 1
5 M6 Flat washer 1
10 M4 Screw 2
8 HLDR SMPS 1
9 M4 Flat washer 2
11 M4 Split LK Washer 2

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 63


Illustrated Parts

7.3 Base

Figure 7-3 : Parts of the Base


Service Part/
Service Part/Kit
FRU KIT Item # Part Description Qty
Description
Number
1 Assembly Base 1
2053657-001 BASE FRU KIT 2 M6 Flat washer 3
3 M6X20 Socket HD Cap Screw 3
1 Assembly Base 1
2060215-001 BASE FRU KIT 2 M6 Flat washer 3
3 M6X20 Socket HD Cap Screw 3
NOTE: 1. If the castor Manufacturer Symbol in castor is TENTE, order 2053657-001 BASE
FRU KIT.
NOTE: 2. If the castor Manufacturer Symbol in castor is SCHIOPPA, order 2060215-001
BASE FRU KIT.

7.4 Torque Wrench


Service Part/
Service Part/Kit
FRU KIT Item # Part description Qty
Description
Number
TORQUE WRENCH
2055914-001 1 Torque Wrench 1
FRU KIT

64 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


Illustrated Parts

7.5 Power

Figure 7-4 : SMPS

Service Part/FRU Service Part/Kit


Item # Part Description Qty
KIT Number Description
2053659-001 POWER SUPPLY FRU KIT 1 Pwr Sply SW , Desktop 1

7.5.1 Country Specific Power Supply Cord


Description Part Number

Power Supply Cord Europe 2037672-001


Power Supply Cord UK 2037674-001
Power Supply Cord Nema 2044041-001
Power Supply Cord Israel 401855-104
Power Supply Cord Argentina 2037679-001
Power Supply Cord India 2037676-001

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 65


Illustrated Parts

7.6 Caster

Figure 7-5 : Caster


Service Part/FRU Service Part/Kit
Item # Part Description Qty
KIT Number Description
1 Pivotal caster wheel with brake 1
2053662-001 CASTER FRU KIT 2 M 10 Flat washer 1
3 M10 Socket Head Screw 1
1 Pivotal caster wheel with brake 1
2060213-001 CASTER FRU KIT
3 M8 Socket Head Screw 1
NOTE: 1. If the castor Manufacturer Symbol in castor is TENTE, order 2053662-001 Castor
FRU KIT.
NOTE: 2. If the castor Manufacturer Symbol in castor is SCHIOPPA, order 2060213-001
Castor FRU KIT.

7.7 Lamp Life Timer

Figure 7-6 : Lamp life timer

Service Part/FRU Service Part/Kit


Item # Part Description Qty
KIT Number Description

Lamp Hour Meter,


2054784-001 HOUR METER FRU KIT 1 1
Electronic

66 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


Illustrated Parts

7.8 Harness Assembly
















Figure 7-7 : Harness Assembly

Service Part/FRU Service Part/Kit
Item # Part Description Qty
KIT Number Description
Harness Assembly XPE, PWA
1 to MCPCB
2

HARNESS Harness Assembly, PWA to


2054787-001
ASSEMBLY FRU KIT
2 Hour Meter
1

Harness Assembly, PWA to


3 Switch & LED
1

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 67


Illustrated Parts

7.9 Hardware Assembly
















Figure 7-8 : Hardware Assembly
Service Part/FRU KIT Service Part/Kit
Item # Part Description Qty
Number Description
1 Knob 2
2 Arm Upper 1
3 Arm Lower 1
HARD WARE FRU 7 Height lock outer 1
2053665-001
KIT 6 Plastic, Ring 1
5 Slide, Inner 1
4 Height Lock Inner 1
Fastener Kit, LED PT 1

7.10 User Manuals


List of user manual in different languages that can be ordered.
Part Number Languages
2051539-001 Lullaby LED PT Operation & maintenance Manual-English
2053788-001 Lullaby LED PT Operation & maintenance Manual- French
2053789-001 Lullaby LED PT Operation & maintenance Manual - Spanish
2056306-001 Lullaby LED PT Operation & maintenance Manual - Indonesian
2053790-001 Lullaby LED PT Operation & maintenance Manual - Portuguese
2053791-001 Lullaby LED PT Operation & maintenance Manual - Turkish
2053792-001 Lullaby LED PT Operation & maintenance Manual - Chinese
2054622-001 Lullaby LED PT Maintenance & service Manual-English


68 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.
Chapter 8: Product Label

Label on the upper cover of the Lamp enclosure

Figure 8-1 : Labels on the upper cover

Label Label Description on the Upper Lamp enclosure


GE lullaby logo
1

Maintain minimum distance of 35 cms between the


2 light source and the patient label

Eye protection label


3

4 Do not move the incubator with the device on it label

5 Refer to instruction manual/booklet label

6 Do not cover vent

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 69


Product Label

Labels on the back panel of the Lamp enclosure

Figure 8-2 : Rear View labels


Label Label Description on Lower Lamp enclosure

1 Over Temperature cut off Indicator

2 Lamp life Timer label

3 DC Current label

4 Irradiance indicator

5 Irradiance selection switch

6 ON/OFF switch

Labels on the bottom panel of the device.

Figure 8-3 : Labels on the bottom panel


Label Label Description on Lower Lamp enclosure

Maintain minimum distance of 35 cms between the light


1
source and the patient label

70 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


Chapter 9: System Electrical

Following is the block diagram of the electrical system of the light unit.

Figure 9-1 : System Electrical

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 71


System Electrical

This page is left blank intentionally.

72 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


Appendix A: Specifications

NOTE: The specifications are subject to change without notice


Specifications
20 W maximum at 100-240 V ~, 50/60 Hz
Power cutoff for temperature greater than or equal to
Over temperature protection
85°C
Less than 500 μA at 264 VAC RMS (power on) with ground
Touch current intact for normal and reverse polarity and with ground
open for normal and reverse polarity.

Environmental Operating Specification


Ambient temperature +10°C to +40°C
Humidity 20% to 95% RH non-condensing
Atmospheric pressure 70 kPa to 106 kPa

Storage and Transportation Requirements


Temperature 0°C to +70°C
Humidity 10% to 95% RH non-condensing
Atmospheric pressure 50 kPa to 106 kPa

Performance Specifications

Spectral Irradiance High Irradiance Mode: 45 µW/ cm2/nm ±25%, 15-point


check at a distance of 35 cm from the light unit
*Using an Ohmeda Medical Low Irradiance Mode: 22 µW/ cm2/nm ±25%, 15-point check
BiliBlanket Meter II at a distance of 35 cm from the light unit
Wavelength range 400 - 550 nm (Dominant wavelength range is 450 - 465 nm)
Typical lamp life is approximately 50000 hours before an
LED Lamps
irradiance drop of 30%

Physical Specification
Overall dimension (Lx Bx H) 530 mmx 550 mmx 1700 mm (at maximum height)

Regulatory Standards
IEC Class 1 (continuous TÜV Rheinland CB certified to the following standards: IEC
operation) 60601-2-50; IEC 60601-1; IEC 60601-1-2
EMC Class -A, CISPR 11, Certified under IECEE CB scheme
Group 1

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 73


Appendix A
This page is left blank intentionally.

74 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


Appendix B: Technical Reference

B.1 Effective Surface Area


The effective surface area of irradiance at a distance of 35 cm from the bed surface is 50
cm x 30 cm, and the maximum irradiance is 45 μW/cm2/nm ±25% at the high irradiance
mode. Once the phototherapy light is on and positioned over the patient, measure the
spectral irradiance with Ohmeda Medical BiliBlanket Meter II.

Figure B-1 : Effective Surface Area

B.1.1 Spectral Irradiance vs Distance

Distance from hood


Surface Area (L x Irradiance Ebi max Mean Irradiance (Ebi
bottom to bed
W) (cm) (µW/ cm2/nm) 15) (µW/ cm2/nm )
surface (cm)

35 50 x 30 45 35
40 50 x 30 40 31
50 50 x 30 31 25

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 75


Appendix B

Figure B-2 : Spectral Irradiance Vs Distance

Figure B-3 : Spectral Response Curve

76 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


Appendix B

B.2 Service Maintenance


The unit should be serviced and maintained by qualified service personnel. Follow hospital
and local regulations for scheduled maintenance frequency.

B.3 Part Replacement


There are specific parts that can be replaced when it is damaged or is not performing as
described. Contact a GE authorized personnel to know more about replaceable parts and
when a replacement is required.
Note: Always use only GE Healthcare replacement parts. Failure to use authentic parts may
result in malfunctioning of the equipment.

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 77


Appendix B
This page is left blank intentionally.

78 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


Appendix C: Electromagnetic Compatibility (EMC)

Changes or modifications to this system not expressly approved by GEHealthcare could


cause EMC failures with this or other equipment. This system is designed and tested to
comply with applicable regulation regarding EMC and needs to be installed and put into
service according to the EMC information stated as follows:

q CAUTION
1. Use of portable phones or other radio frequency (RF)-emitting equipment near the
system could cause unexpected or adverse operation.
2. The equipment or system should not be used adjacent to, or stacked with, other
equipment. If adjacent or stacked use is necessary, the equipment or system should
be tested to verify normal operation in the configuration in which it is being used.

C.1 Electromagnetic Emission


The Lullaby LED Phototherapy System is intended for use in the electromagnetic
environment specified below. It is the responsibility of the customer or user to ensure that
the Lullaby LED Phototherapy System is used in such an environment.

Emission Test Compliance Electromagnetic Environment -Guidance


The equipment uses RF energy only for
its internal function. Therefore, its RF
RF emissions EN 55011 Group 1 emissions are very low and are not likely
to cause any interference in nearby
electronic equipment.
RF emissions EN 55011 Class A The equipment is suitable for hospital
Harmonic Emissions EN or clinic use only. The equipment should
Class A not be used on public, low-voltage power
61000-3-2
networks that supply domestic buildings
Voltage fluctuations/ Flicker
Complies
emissions EN 61000-3-3

Immunity Test EN 60601 Test Compliance Level Electromagnetic


Level Environment -
Guidance
Electrostatic ± 6kV contact ± 6 kV contact Floors should be wood,
discharge (ESD)EN ± 8kV air ±8 kV air concrete or air ceramic
61000-4-2 tile. If floors are covered
with synthetic material,
the relative humidity
should be at least 20 %.

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 79


Appendix C

Immunity Test EN 60601 Test Compliance Level Electromagnetic


Level Environment -
Guidance
Electrical fast ±2kV for power ±2kV for power Mains power quality
transient/burst EN supply lines supply lines should be that of
61000-4-4 ± 1kV for input/ ± 1kV for input/ a typical hospital
output lines output lines environment.
Surge EN 61000-4-5 ± 1kV differential ± 1kV differential Mains power quality
mode mode should be that of
± 2kV common ± 2kV common a typical hospital
mode mode environment.
Voltage dips, short <5% UT (>95% <5% UT (>95% Mains power should
interruptions and be that of a typical
dip in UT ) for 0.5 dip in UT ) for 0.5
voltage variations on hospital environment.
cycles cycles
power supply input If the equipment
lines EN 61000-4-11 40% U (60% dip 40% UT (60% dip requires continued
T operation during power
in UT ) for 5 cycles in UT ) for 5 cycles
mains interruptions,
70% UT (30% it is recommended
70% UT (30%
dip in UT ) for 25 that the Lullaby LED
dip in UT ) for 25 Phototherapy be
cycles
cycles powered from an
<5% UT (>95% uninterrupted power
<5% UT (>95%
dip in UT) for 5 supply.
dip in UT ) for 5
seconds
seconds
NOTE: UT is the a.c mains voltage prior to application of test level.
Power frequency 3A / m 3A / m Power frequency
(50/60 Hz) magnetic magnetic fields should
field EN 61000-4-8 be at levels of a typical
hospital environment.
Conducted RF EN 3 V rms, 150kHz to 3 V rms Interference could
61000-4-6 80MHz occur in the vicinity of
Radiated RF EN 3V / m, 80MHz to 3V / m, 10 V / m equipment marked with
61000-4-3 EN 2.5GHz 10V / m, the following symbol:
60601-2-50

80 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.


Appendix C

Recommended separation distances between portable and mobile RF


communications equipment and the Lullaby LED PT
The Lullaby LED PT is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the Lullaby LED
PT can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the
Lullaby LED PT as recommended below, according to the maximum output power of the
communications equipment.
Separation distance according to frequency of transmitter
(Meters)
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
Rated maximum
output power of
transmitter  3. 5   3. 5  7
d=  P d=  P d=  P
(W)  V1   E1   E1

3Vrms 3V/m 10V/m 3V/m 10V/m


0.01 0.12 0.12 0.04 0.23 0.07
0.1 0.38 0.38 0.11 0.73 0.22
1 1.2 1.2 0.35 2.3 0.7
10 3.8 3.8 1.11 7.3 2.2
100 12 12 1.11 23 7
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in Meters (m) can be estimated using the equation applicable to
the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is

affected by absorption and reflection from structures, objects and people.

C.2 CE Marking Information


Compliance
The Lullaby LED Phototherapy System bears the CE mark, indicating its conformity with
the provisions of the Council Directive 93/42/EEC, concerning medical devices and fulfills
the essential requirements of Annex I of this directive. Any other directive(s) and all the
standards the product complies to are listed in the general information of the operator’s
manual. The country of manufacture can be found on the equipment labeling. The
safety and effectiveness of this device has been verified against previously distributed
devices. Although all the standards applicable to presently marketed devices may not be
appropriate for prior devices (i.e. electromagnetic compatibility standards), this device will
not impair the safe and effective use of those previously distributed devices.
© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 81
Appendix C

C.3 Recommendation
Users should be aware of known RF sources, such as radio or TV stations and hand-held or
mobile two-way radios, and consider them when installing a medical device or system. Be
aware that adding accessories or components, or modifying the medical device or system
may degrade the EMI performance. Consult with qualified personnel regarding changes to
the system configuration.
Operating the system near radio frequency (RF) electromagnetic interference (EMI) above
the conditions defined in the EMC Standard EN60601-1-2 for Radiated Immunity (field
strengths above 3 V/m) may cause malfunctions.
Medical Electrical Equipment needs special precautions regarding EMC and needs to
be installed and put into service according to the EMC information provided in this
manual. Review the AAMI Committee Technical Information Report (TIR) 18, “Guidance on
Electromagnetic Compatibility of Medical Devices for Clinical/Biomedical Engineers”. This
guidance document provides a means to evaluate and manage the EMI environment in the
hospital. The following actions can be taken to reduce the risk of medical device EMI and
achieve EMC:
• Assess the EMC environment of the healthcare facility (e.g., identify radio
transmitters in around the facility) and identify areas where critical medical
devices are used (e.g., ER, ICU, CCU, NICU).
• Increase the distance between sources of EMI and susceptible devices.
• Remove the devices that are highly susceptible to EMI.
• Lower the power transmitted from electrical and electronic equipment (EMI
sources) under hospital control (i.e. paging systems).Label devices susceptible to
EMI.
• Educate healthcare facility staff (nurses and doctors) to be aware of, and to
recognize, potential EMI related problems.

Notes

LED Phototherapy System

Description Number
Serial number of the unit
NOTE: For the serial number of the device, refer to the rating label on the Lamp assembly.
Record the serial number of the device in the space provided above for reference.
82 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.
Warranty

This Product is sold by GE Healthcare under the warranties set forth in the following
paragraphs. Such warranties are extended only with respect to the purchase of this Product
directly from GE Healthcare or GE Healthcare’s Authorized Dealers as new merchandise
and are extended to the Buyer thereof, other than for the purpose of resale. For a period
of twelve (12) months for the light unit from the date of original delivery to Buyer or to
Buyer’s order, but in no event for a period of more than two years from the date of original
delivery by GE Healthcare to a GE Healthcare Authorized Dealer, this Product, other than
its expendable parts, is warranted to be free from functional defects in materials and
workmanship and to conform to the description of the Product contained in this operation
manual and accompanying labels and/or inserts, provided that the same is properly
operated under the conditions of normal use, that regular periodic maintenance and
service is performed and that replacements and repairs are made in accordance with the
instructions provided.
The foregoing warranties shall not apply if the Product has been repaired other than by
GE Healthcare or in accordance with written instructions provided by GE Healthcare, or
altered by anyone other than GE Healthcare, or if the Product has been subject to abuse,
misuse, negligence, or accident. GE Healthcare’s sole and exclusive obligation and Buyer’s
sole and exclusive remedy under the above warranties is limited to repairing or replacing,
free of charge, at GE Healthcare’s option, a Product, which is telephonically reported to the
nearest GE Healthcare Regional Service Office and which, if so advised by GE Healthcare,
is thereafter returned with a statement of the observed deficiency, not later than seven (7)
days after the expiration date of the applicable warranty, to the designated GE Healthcare
Service Center during normal business hours, transportation charges prepaid, and which,
upon GE Healthcare’s examination, is found not to conform with above warranties. GE
Healthcare shall not be otherwise liable for any damages including but not limited to
incidental damages, consequential damages, or special damages. There are no express
or implied warranties, which extend beyond the warranties hereinabove, set forth. GE
Healthcare makes no warranty of merchantability or fitness for a particular purpose with
respect to the product or parts thereof.

© 2011 by General Electric Company. All rights reserved. 2054622-001 Rev E 83


North America Asia Pacific
Datex-Ohmeda, Inc. China
PO Box 7550 GE Healthcare
Madison, Wisconsin 53707-7550 Maxdo Center No. 8 Xing Yi Road,
USA Hong Qiao Development Zone
Tel +1 800 345 2700 Shanghai , China
Tel + 65 62773444
Europe, Middle East, Africa
GE Healthcare Japan
P.O. Box 900 67-4 Takakura-cho, Hachioji-shi,
FIN-00031 GE Tokyo, 192-0033, Japan
Finland
Tel +358 10 39411 Australia & New Zealand
Fax +358 9 146 3310 Unit 3, 310 Ferntree Gully Road,
Nottinghill, Victoria, 3168, Australia
Latin America
GE Healthcare South East Asia
Av. Das Nacoes Unidas, 8501 - 3rd Floor Singapore
Sao Paulo - SP Tiong Bahru Road Central Plaza
Brazil - 05425-070 #12-01/06, 168730, Singapore
Tel: (55-11) 3067-8000
Korea
Ohmeda Medical, 7th Floor, GE Tower 71-3, Cheongdam-
A Division of Datex-Ohmeda, Inc., dong, Gangnam-gu,
A General Electric Company Seoul, 135-100, Korea
8880 Gorman Road
Laurel MD 20723
USA

EC Representative
GE Medical Systems SCS
283 Rue de la Minière
78530 BUC
FRANCE

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