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GE Healthcare

Lullaby™
LED Phototherapy System
Service Manual

Service Manual
English
2054622-001
Rev J
© 2015 by General Electric Company.
All rights reserved.
© 2015 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.

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.

Warranty

This product is sold by GE Healthcare with a period of 12-month* warranty that covers labor
and parts under the terms and conditions set forth in the GE Healthcare Warranty Statement
presented to the customer at the point of sale.

* 12-month is the minimum warranty period offered. Warranty period may vary from region to region.
Refer to GE Healthcare Warranty Statement presented to the customer at the point of sale for details.

q CAUTION
In the United States of America, Federal Law restricts this device to sale by or on the order
of a Physician.

2 2054622-001 Rev J © 2015 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 клиента


(BG) 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.

© 2015 by General Electric Company. All rights reserved. 2054622-001 Rev J 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 verantwoordelijk
(NL)
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, vastutab
(ET)
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 J © 2015 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 l’anglais,
(FR)
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.

© 2015 by General Electric Company. All rights reserved. 2054622-001 Rev J 5


FIGYELMEZTETÉS

Ezen karbantartási kézikönyv kizárólag angol nyelven érhető el.

• Ha a vevő szolgáltatója angoltól eltérő nyelvre tart igényt, akkor a vevő felelőssége a
(HU)
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 è


(IT)
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 J © 2015 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.

© 2015 by General Electric Company. All rights reserved. 2054622-001 Rev J 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 idioma,
(PT-PT)
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.

UPOZORENJE

Ovo servisno uputstvo je dostupno samo na engleskom jeziku.

• Ako klijentov serviser zahteva neki drugi jezik, klijent je dužan da obezbedi prevodilačke
(SR)
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.

8 2054622-001 Rev J © 2015 by General Electric Company. All rights reserved.


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.

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.

© 2015 by General Electric Company. All rights reserved. 2054622-001 Rev J 9


This page is left blank intentionally.

10 2054622-001 Rev J © 2015 by General Electric Company. All rights reserved.


Table of Contents
About this Manual����������������������������������������������������������������������������������������������������������13
Important Safety Information��������������������������������������������������������������������������������������17
Chapter 1: Product Description������������������������������������������������������������������������������������21
1.1 Features����������������������������������������������������������������������������������������������������������������������������������������������� 21
1.3 Controls, Indicators, Mechanical controls��������������������������������������������������������������������������� 22
1.3.1 Controls��������������������������������������������������������������������������������������������������������������������������������� 22
1.3.2 Indicators����������������������������������������������������������������������������������������������������������������������������� 23
1.3.3 Mechanical Controls������������������������������������������������������������������������������������������������������� 24

Chapter 2: Installation and Setup��������������������������������������������������������������������������������25


2.1 Installation Instructions���������������������������������������������������������������������������������������������������������������� 25
2.1.1 Tool Requirements���������������������������������������������������������������������������������������������������������� 25
2.1.2 Installation Duration������������������������������������������������������������������������������������������������������� 25
2.2 Unpacking the box������������������������������������������������������������������������������������������������������������������������� 26
2.3 Assembling the LED Phototherapy System������������������������������������������������������������������������� 26
2.3.1 Fixing the Pedestal Assembly to the Base ����������������������������������������������������������� 27
2.4 Fixing the Arm and Lamp Enclosure�������������������������������������������������������������������������������������� 29
2.5 Attaching the Power Supply������������������������������������������������������������������������������������������������������� 31
2.6 Turning ON the System���������������������������������������������������������������������������������������������������������������� 32
2.7 Adjusting the height of the pedestal�������������������������������������������������������������������������������������� 32
2.8 Tilting the Lamp Enclosure��������������������������������������������������������������������������������������������������������� 33
2.9 Moving the Unit�������������������������������������������������������������������������������������������������������������������������������� 34
2.10 Using the Lamp enclosure without the Pedestal����������������������������������������������������������� 34
2.11 Repacking the LED Phototherapy System for Local Transportation�������������������� 35

Chapter 3: Maintenance and Checkout����������������������������������������������������������������������37


3.1 Procedure Schedules��������������������������������������������������������������������������������������������������������������������� 37
3.2 Tool Requirements�������������������������������������������������������������������������������������������������������������������������� 37
3.3 Maintenance and Checkout Procedures������������������������������������������������������������������������������ 38
3.3.1 Visual Inspection�������������������������������������������������������������������������������������������������������������� 38
3.3.2 Functional Checks������������������������������������������������������������������������������������������������������������ 38
3.3.3 Light Intensity Check������������������������������������������������������������������������������������������������������ 38
3.3.4 Electrical Safety Test������������������������������������������������������������������������������������������������������� 38

Chapter 4: Calibration����������������������������������������������������������������������������������������������������39
Chapter 5: Troubleshooting������������������������������������������������������������������������������������������41
Chapter 6: Replacement Procedures���������������������������������������������������������������������������49
6.1 Preliminary Operation������������������������������������������������������������������������������������������������������������������� 49

11 2054622-001 Rev J © 2015 by General Electric Company. All rights reserved.


Table of Contents
6.2 Replacing parts in Lamp Enclosure����������������������������������������������������������������������������������������������� 50
6.2.1 Removing the Upper Arm ������������������������������������������������������������������������������������������������� 50
6.2.2 Removing the Lamp enclosure upper cover�������������������������������������������������������������� 50
6.2.3 Removing the Driver Board����������������������������������������������������������������������������������������������� 51
6.2.4 Removing the Heat sink ������������������������������������������������������������������������������������������������������ 53
6.2.5 Replacing the Base����������������������������������������������������������������������������������������������������������������� 54
6.2.6 Replacing the Casters����������������������������������������������������������������������������������������������������������� 54
6.2.7 Replacing the Lower arm �������������������������������������������������������������������������������������������������� 54
6.2.8 Replacing Lamp Hour Timer���������������������������������������������������������������������������������������������� 55
6.2.9 Replacing the Harness Assembly������������������������������������������������������������������������������������ 55

Chapter 7: Illustrated Parts�����������������������������������������������������������������������������������������������59


7.1 Lamp Unit������������������������������������������������������������������������������������������������������������������������������������������������� 59
7.2 Base�������������������������������������������������������������������������������������������������������������������������������������������������������������� 61
7.3 Torque Wrench���������������������������������������������������������������������������������������������������������������������������������������� 62
7.4 Power����������������������������������������������������������������������������������������������������������������������������������������������������������� 62
7.5 Caster���������������������������������������������������������������������������������������������������������������������������������������������������������� 63
7.6 Lamp Life Timer�������������������������������������������������������������������������������������������������������������������������������������� 63
7.7 Harness Assembly��������������������������������������������������������������������������������������������������������������������������������� 64
7.8 Hardware Assembly������������������������������������������������������������������������������������������������������������������������������ 65
7.9 User Manuals������������������������������������������������������������������������������������������������������������������������������������������� 65
7.10 Product Labels�������������������������������������������������������������������������������������������������������������������������������������� 66

Appendix A: Specifications�������������������������������������������������������������������������������������������������69
Appendix B: Technical Reference��������������������������������������������������������������������������������������71
B.1 Effective Surface Area������������������������������������������������������������������������������������������������������������������������� 71
B.1.1 Spectral Irradiance vs Distance��������������������������������������������������������������������������������������� 71

Appendix C: Electromagnetic Compatibility (EMC)��������������������������������������������������������73


C.1 Electromagnetic Emission����������������������������������������������������������������������������������������������������������������� 73
C.2 Recommendation����������������������������������������������������������������������������������������������������������76

Appendix D: Wiring Diagram���������������������������������������������������������������������������������������������77

12 2054622-001 Rev J © 2015 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

© 2015 by General Electric Company. All rights reserved. 2054622-001 Rev J 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 J © 2015 by General Electric Company. All rights reserved.


About this Manual

Symbol Description

Prescription Device Label for United States.

EurAsian Conformity Mark

To indicate mass

© 2015 by General Electric Company. All rights reserved. 2054622-001 Rev J 15


About this Manual
This page is left blank intentionally.

16 2054622-001 Rev J © 2015 by General Electric Company. All rights reserved.


Important Safety Information

The information presented in this section is important for the safety of both the patient and
operator and also serves to enhance equipment reliability.
Before servicing the Lullaby LED Phototherapy system, read through this entire manual. As
with all medical equipment, attempting to use this device without a thorough understanding
of its operation may result in patient or user injury. This device should only be serviced by
authorized service personnel. Additional precautions specific to certain procedures are found
in the text of this manual.
The information contained in this service manual pertains only to those models of products,
which are marketed by GE Healthcare as of the effective date of this manual or the latest
revision thereof. This service manual was prepared for exclusive use by GE Healthcare service
personnel in light of their training and experience as well as the availability to them of parts,
proper tools, and test equipment. Consequently, GE Healthcare provides this service manual
to its customers purely as a business convenience and for the customer’s general information
only without warranty of the results with respect to any application of such information.
Furthermore, because of the wide variety of circumstances under which maintenance and
repair activities may be performed and the unique nature of each individual’s own experience,
capacity, and qualifications, the fact that a customer has received such information from GE
Healthcare does not imply in any way that GE Healthcare deems said individual to be qualified
to perform any such maintenance or repair service. Moreover, it should not be assumed that
every acceptable test and safety procedure or method, precaution, tool, equipment or device
is referred to within, or that abnormal or unusual circumstances may not warrant or suggest
different or additional procedures or requirements. This manual is subject to periodic review,
update and revision. Customers are cautioned to obtain and consult the latest revision before
undertaking any service of the equipment
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.

Warnings, Cautions and Notes


The following safety precautions must be observed during all phases of operation, service,
and repair of this equipment. Failure to comply with these precautions, or with specific
warnings elsewhere in this manual, violates safety standards of design, manufacture, and
intended use of the equipment.
The warnings and cautions in this section relate to the equipment in general and apply to all
aspects of the equipment. Be sure to read the other chapters because there are additional
warnings and cautions that relate to specific features of the equipment.

© 2015 by General Electric Company. All rights reserved. 2054622-001 Rev J 17


Important Safety Information

When grouped, cautions and warnings are listed alphabetically and do not imply any order
of importance.

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.
To avoid the risk of electric shock, this equipment must only be connected to a
supply mains with protective earth.

Do not modify this equipment without authorization of the manufacturer.

Effect of blue light: Blue light can hinder clinical observations by masking skin
color changes, such as cyanosis.

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.

18 2054622-001 Rev J © 2015 by General Electric Company. All rights reserved.


Important Safety Information

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 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.

Medical Electrical Equipment needs to be installed and put into service strictly
according to the EMC information provided in this manual.

Portable and mobile RF communications equipment can affect Medical


Electrical Equipment.

© 2015 by General Electric Company. All rights reserved. 2054622-001 Rev J 19


Important Safety Information
This page is left blank intentionally.

20 2054622-001 Rev J © 2015 by General Electric Company. All rights reserved.


Chapter 1: 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.

1.1 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 10
2.1
2.2 LED lamps enclosed in a plastic housing, which
2.3 forms the light source. It consists of two parts-
the upper enclosure and the lower enclosure. The
1.2 1 2.4 lamp enclosure can be tilted to approximately
2.5 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 detached
2.8
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 1-1 : 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.

© 2015 by General Electric Company. All rights reserved. 2054622-001 Rev J 21


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

1.3 Controls, Indicators, Mechanical controls


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

1.3.1 Controls

DC Jack (Refer Figure 1-2): 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 1-2 : DC Jack 2. It may also create an unsafe operating
condition, exposing a user to electric shock.

22 2054622-001 Rev J © 2015 by General Electric Company. All rights reserved.


Product Description

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


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

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

1.3.2 Indicators
Over Temperature Cut-Off Indicator (Refer Figure
1-4): 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 1-4 : Over temperature cut-off


indicator

Lamp Life Timer (Refer Figure 1-5): 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 1-5 : Lamp life timer

© 2015 by General Electric Company. All rights reserved. 2054622-001 Rev J 23


Product Description

1.3.3 Mechanical Controls


Height Adjust Lock (Refer Figure 1-6): 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 1-6 : Height adjust lock


SMPS Holder (Refer Figure 1-7): The holder is
To DC Jack fixed to the outer tube to support the SMPS (power
supply unit).
SMPS (Refer to Figure 1-7): 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 1-7 : SMPS with power cables in the device.
SMPS holder
Base (Refer Figure 1-8): The base keeps the device
unit in a stable position.
Casters with position lock (Refer Figure 1-9):
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 1-8 : 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 1-9 Caster with brake lever

24 2054622-001 Rev J © 2015 by General Electric Company. All rights reserved.


Chapter 2: Installation and Setup

2.1 Installation Instructions


This chapter provides information required to prepare for and perform installation of Lullaby
LED Phototherapy system.

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.

2.1.1 Tool Requirements


Standard service tool kit(1), Torque Wrench 2Nm-8Nm range (1)

2.1.2 Installation Duration


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

Section 2.2 begins in the next page.

© 2015 by General Electric Company. All rights reserved. 2054622-001 Rev J 25


Installing and Setup

2.2 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 Foam

Upper & Lower Arm Height Lock

Outer Tube
SMPS
SMPS holder
Inner Tube

End Fitting (Dead Weight)

Base
Lamp
enclosure Bottom Foam

Box

Figure 2-1 : Unpacking the box


Follow the below instructions to unpack the box:
1. Cut the straps and remove the top foam out of the box.
2. Lift all the parts from the box and place it on a clean flat surface.
3. Remove the shrink wrap on the parts before assembly.
Preserve the packaging so that it can be used to repack when the LED Phototherapy System
when it is being transported locally.

The LED Phototherapy system should not be subjected to outdoor transport in


assembled condition.

2.3 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.

26 2054622-001 Rev J © 2015 by General Electric Company. All rights reserved.


Installing and Setup

2.3.1 Fixing the Pedestal Assembly to the Base


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

End Fitting
(Dead Weight)

M6 Screws

Figure 2-3 : Fixing the Outer tube and End


Fitting

© 2015 by General Electric Company. All rights reserved. 2054622-001 Rev J 27


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 figure
Slide inner 2-4 and insert it into the Outer tube
M6 Flat washer along the orientation. Orient the
M6 Screw clearance provided in slide inner to
Suspension spring the weld line inside the outer tube
pedestal (See figure 2-5).
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 2-4 :Fitting the Inner tube into the


Outer tube

Clearance in Slide
inner
Welded seam on
Outer tube
:

Figure 2-5 Orientation of the Outer tube

28 2054622-001 Rev J © 2015 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 out.
M4 Screws
Instructions to dismantle the Pedestal
assembly
1. When dismantling the Inner tube
remove the Lamp enclosure and the
Arm. (Do the reverse of procedures in
Figure 2-6 :Fixing the SMPS Holder section 2.4 and 2.5)
2. Loosen the Height lock and reverse
the procedure of installing the Inner
tube.

2.4 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, the
M4
lower arm and the upper arm that are held
Screws
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 2-7.
2. Fasten the two M4 screws by
applying tightening torque of 2 Nm
Inner tube using torque wrench.
NOTE: Before fixing the upper arm, place
the Lamp enclosure on the horizontal
groove in the lower arm (Figure 2-8).

Figure 2-7 : Fixing the lower arm to the


pedestal

© 2015 by General Electric Company. All rights reserved. 2054622-001 Rev J 29


Installing and Setup

Product Illustration Instruction

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

The Lamp enclosure is a fully assembled


unit.
Horizontal
hinge 3. Hold the Lamp enclosure vertically
Grooves as shown in Figure 2-8 and place 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 2-8 : Fixing the Lamp enclosure upper arm. This secures the Lamp
enclosure on the pedestal. Refer
Knobs figure 2-9.
NOTE: For tilting the Lamp enclosure, refer
Upper arm to section “2.8”.

Figure 2-9 : 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.

30 2054622-001 Rev J © 2015 by General Electric Company. All rights reserved.


Installing and Setup

2.5 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 2-10.
3. Fix the power cord to the SMPS as shown in
Figure 2-11. 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 2-10 : DC jack

SMPS

AC power cord
point

Figure 2-11 : SMPS unit

Note : Upon completing the installation, perform the checkout procedures as described in
“Chapter 3”.

© 2015 by General Electric Company. All rights reserved. 2054622-001 Rev J 31


Installing and Setup

2.6 Turning ON the System


Product Illustration Description
Instructions to switch-ON the unit
1. Connect the power cables as
described in section “2.5”.
2. Turn ON the Power ON/OFF switch.
(Figure 2-12)
Power 3. Select the irradiance level with the
switch Irradiance selection switch. The
Irradiance nominal output at high intensity is:
Lamp hour Over temperature select 45 µW/ cm2/nm and 22 µW/ cm2/
meter cut-off indicator switch nm at low intensity setting.
4. The Overheat 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 2-12 :Switches and Indicator
5. The Lamp Hour Meter displays 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.

2.7 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 counterclockwise.
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 2-13 :Height Lock
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.
32 2054622-001 Rev J © 2015 by General Electric Company. All rights reserved.
Installing and Setup

2.8 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
2-14 by turning it counterclockwise.
2. Tilt the Lamp enclosure about the hinge to
the desired angle, see Figure 2-15. 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 2-14 : Front knob
2. Ensure that the knob is tightened
thoroughly.

Figure 2-15 : Tilting the Lamp


enclosure at an angle

© 2015 by General Electric Company. All rights reserved. 2054622-001 Rev J 33


Installing and Setup

2.9 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 2-16 :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.

2.10 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.

34 2054622-001 Rev J © 2015 by General Electric Company. All rights reserved.


Installing and Setup

Product Illustration Description


Instructions to detach the Lamp
enclosure from the pedestal
1. Switch off the power from the wall
power plug and disconnect the
power supply cord.
2. Remove the power supply cord
from the DC jack.
3. Remove the upper arm (Refer to
instructions in section 2.4).
4. Hold Lamp enclosure, tilt and lift it
off from the arm.
5. 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.

2.11 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.

© 2015 by General Electric Company. All rights reserved. 2054622-001 Rev J 35


Installing and Setup

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

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.

36 2054622-001 Rev J © 2015 by General Electric Company. All rights reserved.


Chapter 3: Maintenance and Checkout
This chapter includes preventive maintenance procedures as well as checkout procedures
required after installation, repair, or corrective maintenance.

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.

3.1 Procedure Schedules


The following table lists all maintenance and checkout procedures, and specifies when and
how often each procedure should be performed.
For good care and maintenance of the LED Phototherapy system, perform preventive
maintenance procedures at specific time intervals. The checkout procedures shall be
performed after any installation, repair, maintenance, or part replacement as specified below.
Table 3-1 Checkout Procedure Schedule
Checkout to be performed
Checkout Procedure Name after first as Preventive after Repair or
Installation Maintenance Part Replacement
3.3.1 Visual Inspection YES Annually YES
3.3.2 Functional Checks YES Annually YES
3.3.3 Light Intensity Check YES Annually YES
3.3.4 Electrical Safety Test NO 1
Annually YES
1
Electrical safety test is not required after the first installation of the product. Each product unit is tested
in the factory prior to shipment to the customer.

3.2 Tool Requirements


Table 3-2 Checkout Procedure Tool Requirements
Checkout Procedure Name Service Tools Needed Quantity Needed
3.3.1 Visual Inspection None Not applicable
3.3.2 Functional Checks None Not applicable
Ohmeda Medical BiliBlanket
3.3.3 Light Intensity Check 1
Meter II
3.3.4 Electrical Safety Test Safety Analyzer 1

© 2015 by General Electric Company. All rights reserved. 2054622-001 Rev J 37


Maintenance and Checkout

3.3 Maintenance and Checkout Procedures


3.3.1 Visual Inspection
1. Examine the power cord for obvious signs of damage. Replace the power cord if damage
is evident.
2. Examine both the systems for any damaged (cracked or broken) or missing parts. If any
part is damaged or missing, replace it.
3. Examine the air vent for any obstruction and clear them, if any.
4. Loosen the knobs*, check the tilting mechanism of the Lamp enclosure and ensure that
it remains in the selected angle when the knobs are tightened.
5. Check the height adjust function to ensure that the pedestal tube slides and stays in
place at the chosen height, when locked.
6. Check the casters and the brakes for proper functioning.
7. Examine both the systems for any missing labels. Make sure the labels are attached in
the proper locations.
8. For a list of labels and their proper locations, refer to section “7.11”.
3.3.2 Functional Checks
The electrical controls are mounted on the Lamp enclosure.
1. Connect the power supply cable from the SMPS to the DC jack on the lamp enclosure.
2. Turn ON the Power ON/OFF switch. Check all the LED lamps are lit.
3. Check if the lamp life timer is ON and confirm that the timer increments after 6 minutes.
3.3.3 Light Intensity Check
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 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%.
3.3.4 Electrical Safety Test
Use an approved electrical safety analyzer and follow the operating instructions supplied
by the manufacturer of the electrical safety analyzer to perform the earth leakage current
check.
1. In normal conditions and in all possible operating modes, the earth leakage current shall
be less than 5mA.
2. If required by local ordinances, in single fault condition and in all possible operating
modes, the earth leakage current shall be less than 10mA.

*Lamp unit must not be tilted without the knobs being loosened. It could result in cracking of the lamp
enclosure and the tilt mechanism

38 2054622-001 Rev J © 2015 by General Electric Company. All rights reserved.


Chapter 4: Calibration

Lullaby LED Phototherapy system does not need any calibration.

© 2015 by General Electric Company. All rights reserved. 2054622-001 Rev J 39


Calibration
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40 2054622-001 Rev J © 2015 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 “Important Safety Information” on page 17 before starting any
troubleshooting.

ID Symptom Possible Causes Actions and Solutions

Tilt knobs are not Loosen, tilt and hold the lamp unit in desired
loosened position and tighten the knob.
Replace the knobs (See Hardware FRU kit).
Knobs

Upper arm
Lamp enclosure
S1
cannot be tilted
Damaged knobs

Check if the thread on the knob is damaged.


Damaged knobs
Replace the knobs if necessary.
Replace the Enclosure Assembly Lamp
Upper.

Lamp enclosure Lamp enclosure


Hinge is damaged
does not or the upper
S2
remain at the enclosure
selected angle around the hinge
is cracked or Horizontal hinge
damaged.
Grooves

Lower arm

© 2015 by General Electric Company. All rights reserved. 2054622-001 Rev J 41


Troubleshooting

ID Symptom Possible Causes Actions and Solutions

Replace Lower Arm.

Lamp
enclosure

Damaged Lower
Arm
Horizontal hinge

Lower arm

Lamp Enclosure Remove the upper arm cover and check the
S3
is drooping screws. If being loose, tighten screws using
2.5mm hex keys, using a torque of 2 Nm.
M4 Screws

Lower Arm not


properly engaged
to the inner tube Lower arm

Inner tube

42 2054622-001 Rev J © 2015 by General Electric Company. All rights reserved.


Troubleshooting

ID Symptom Possible Causes Actions and Solutions

Disengage Height Lock and tighten again


Height lock inner
Height lock outer

Inner tube

Slide inner
M6 Flat washer
M6 Screw

Height Lock is not Suspension spring


properly engaged pedestal

Inner tube is Outer tube


S4
sliding down

SMPS
holder

Threads of Height Replace Height Lock using Hardware FRU


Lock is damaged kit.
Height Lock Inner is Order Height Lock Inner (Hardware FRU Kit)
not installed and install it.
Brakes applied Release brakes on all four wheels.
Replace castors.
If the castor Manufacturer Symbol in castor
S5 No Mobility Damaged Castors,
is TENTE, order 2053657-001 BASE FRU KIT.
or jammed Wheel
brake levers If the castor Manufacturer Symbol in castor
is SCHIOPPA, order 2060215-001 BASE FRU
KIT.

© 2015 by General Electric Company. All rights reserved. 2054622-001 Rev J 43


Troubleshooting

ID Symptom Possible Causes Actions and Solutions

1. Turnoff Mains Switch, disconnect


power cord from outlet
2. Ensure Air Vents on the light units are
not blocked
Overheat 3. Ensure area around the equipment is
S6 Unit is overheated
Indicator is ON not congested and is well ventilated by
air conditioning or by natural means
4. Allow the unit to cool down
5. Plug the power cord and turn the unit
back ON
Check if over temperature cut-off indicator
Unit is overheated is ON. Allow the unit to cool down (Refer to
Blue LED light is S6).
S7
not illuminating
Defective lamp life
Refer S10
timer.

44 2054622-001 Rev J © 2015 by General Electric Company. All rights reserved.


Troubleshooting

ID Symptom Possible Causes Actions and Solutions

Loose connection Remove the lamp enclosure and the upper


inside Lamp cover. Visually check for loose connectors.
enclosure Fix if any.
Do a continuity check on the harness
assembly. Replace LED driver to MCPCB
Harness Assembly (See FRU Harness
Assembly Kit), if necessary.

Broken connection
MCPCB
between LED driver Harness
to MCPCB harness J2 J3
assembly

Right group of
LED lights or
S8 1. Remove Harness assembly connected
Single LED is
not illuminating to J2 connector of LED driver.
2. Measure voltage across pins 3 (1A) & 4
LED Driver board (1C) of J2. The voltage should be in 16V
failure DC - 24V DC range.
3. If measured voltage is outside of the
above-mentioned range, replace the
LED driver board.
1. In Power OFF mode, Remove Harness
assembly connected to J3 connector
of LED Driver and connect J2 Harness
assembly
MCPCB failure 2. Power ON and check if MCPCB
assembly is functioning (i.e. LED lights
are illuminating). If not, replace MCPCB
(new versions of MCPCB and LED driver
boards are not backward compatible).

© 2015 by General Electric Company. All rights reserved. 2054622-001 Rev J 45


Troubleshooting

ID Symptom Possible Causes Actions and Solutions

Loose connection Remove the lamp enclosure and the upper


inside Lamp cover. Visually check for loose connectors.
Enclosure Fix if any.
Do a continuity check on the harness
assembly. Replace LED driver to MCPCB
Harness Assembly (See FRU Harness
Assembly Kit), if necessary.

Broken connection
MCPCB
between LED driver
Harness
to MCPCB harness J2 J3
assembly

Left Group of
LED lights or
S9 1. Remove Harness assembly connected
Single LED is
not illuminating to J3 connector of LED driver.
2. Measure voltage across pins 3 (1A) & 4
(1C) of J3. The voltage should be in 16V
LED Driver failure
DC - 24V DC range.
3. If measured voltage is outside of the
above-mentioned range, replace LED
driver.
1. In Power OFF mode, Remove Harness
assembly connected to J2 connector
of LED Driver and connect J3 Harness
assembly.
MCPCB failure 2. Power ON and check if MCPCB
assembly is functioning (i.e. LED lights
are illuminating). If not, replace MCPCB.
(new versions of MCPCB and LED driver
boards are not backward compatible).

46 2054622-001 Rev J © 2015 by General Electric Company. All rights reserved.


Troubleshooting

ID Symptom Possible Causes Actions and Solutions

Broken connection
Dismantle Lamp Enclosure, remove upper
between LED driver
cover. Check the LED driver to Lamp Hour
to Lamp Hour
Lamp life meter Harness assembly for continuity. If
meter Harness
timer is not defective, replace the harness assembly.
assembly.
S10 functioning, but
Check if Over temperature cut-off indicator
LED blue lights
Unit is overheated (RED color) is lit. If lit, allow the unit to cool
are ON.
down (Refer to S6).
Lamp Hour Meter
Replace the Lamp Hour Meter.
is defective
AC Power cord is Check the power cord and insert properly if
inserted loosely needed; both at Mains and in SMPS
Defective Power Remove AC power cord, check for continuity,
cord and replace if needed.

Unit will not LED Driver to Remove Upper Lamp Enclosure. Check for
S11 power ON Switches Harness continuity of LED driver to Switches Harness
assembly is Assembly. Replace LED driver to Switches
defective Harness Assembly.
Remove DC plug from the unit and measure
Defective SMPS the voltage. Confirm the voltage is 24V +/-
1V DC. Replace SMPS if necessary.
Defective LEDs on
either left or right Refer to S8 and S9.
side
LED Driver to
Visually check the harness assembly for
Switches Harness
Irradiance loose connection, rectify if any. Replace the
Assembly is
S12 control is not harness if necessary.
defective
working
Defective Switch
Check for continuity of single pole switch
on LED Driver to
in the LED Driver to Switches Harness
Switches Harness
Assembly. Replace the harness if necessary.
Assembly
LED Driver failure. Replace LED driver.

© 2015 by General Electric Company. All rights reserved. 2054622-001 Rev J 47


Troubleshooting
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48 2054622-001 Rev J © 2015 by General Electric Company. All rights reserved.


Chapter 6: Replacement Procedures

6.1 Preliminary Operation


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).

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
• 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.

© 2015 by General Electric Company. All rights reserved. 2054622-001 Rev J 49


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

50 2054622-001 Rev J © 2015 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.

© 2015 by General Electric Company. All rights reserved. 2054622-001 Rev J 51


Replacement Procedure

Switch and MCPCB harness Lamp life time harness

Heat sink assembly 2


Heat sink assembly 1 M C P C B
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.

52 2054622-001 Rev J © 2015 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.

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

© 2015 by General Electric Company. All rights reserved. 2054622-001 Rev J 53


Replacement Procedure

6.2.5 Replacing the Base


1. Actuate the caster brakes.
2. 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.
3. Pull the Inner tube & suspension spring from the Outer tube of the Pedestal assembly
4. Once the inner parts of the outer tube are safely dismantled and removed, proceed as
below.
5. Unscrew the casters from the Base using the 8 mm hex key and keep it aside.
6. Replace the Base and assemble the casters on the new Base. For details on replacing
the casters, see section “6.2.6”.
7. Assemble the Pedestal assembly and place the Lamp enclosure into position.

Figure 6-9 : Fixing Base

6.2.6 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 6-10 :Fixing the caster


2. Replace the caster and tighten the bolt using the 8mm hex key.
6.2.7 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.

54 2054622-001 Rev J © 2015 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 6-11 : Lower arm


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

6.2.8 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 6-12 : Lamp hour timer

6.2.9 Replacing the Harness Assembly


Following steps enumerate the procedure to replace the Harness Assembly.

6.2.9.1 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).
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.

© 2015 by General Electric Company. All rights reserved. 2054622-001 Rev J 55


Replacement Procedure
3. Reverse step 1 to install.

MCPCB J2 J3
Harness

Figure 6-13 MCPCB harness and connectors

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 6-14 : Pin location on the Driver board

56 2054622-001 Rev J © 2015 by General Electric Company. All rights reserved.


Replacement Procedure

6.2.9.2 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 6-15 : Switch harness

© 2015 by General Electric Company. All rights reserved. 2054622-001 Rev J 57


Replacement Procedure
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58 2054622-001 Rev J © 2015 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

© 2015 by General Electric Company. All rights reserved. 2054622-001 Rev J 59


Illustrated Parts

Service Part/
Service Part/Kit
FRU KIT Item # Part Description Qty
Description
Number
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
PWA, LED PT DRIVER FOR
9 1
FRU, CKT BD PCP XPE-A01
2072988-001
Lullaby LED PT Driver*** 7 M3 Screw 4
8 Flat Washer, M3 4
*Part carries the product serial number label. So Lamp Upper FRU Kit (2053648-001) can only be replaced
in a GE service depot for product traceability purposes.
**For units with LED driver board part number 2063015-001 or 2051642-001, Order two MCPCB FRU kits
(2053651-001) and replace both MCPCBs even if only one is defective and also replace the LED driver
board with a new driver board FRU part number 2072988-001.
***For product serial numbers starting from SGT12501505PA, user FRU part number 2072988-001 to
order LED driver board.

60 2054622-001 Rev J © 2015 by General Electric Company. All rights reserved.


Illustrated Parts

7.2 Base

Figure 7-2 : 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.

© 2015 by General Electric Company. All rights reserved. 2054622-001 Rev J 61


Illustrated Parts

7.3 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

7.4 Power

Figure 7-3 : 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

62 2054622-001 Rev J © 2015 by General Electric Company. All rights reserved.


Illustrated Parts

7.5 Caster

Figure 7-4 : 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.

7.6 Lamp Life Timer

Figure 7-5 : Lamp life timer

© 2015 by General Electric Company. All rights reserved. 2054622-001 Rev J 63


Illustrated Parts

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

7.7 Harness Assembly
















Figure 7-6 : Harness Assembly

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

HARNESS Harness Assembly, PWA to


2054787-001
ASSEMBLY FRU KIT
2 Hour Meter
1

Harness Assembly, PWA to


3 Switch & LED
1

64 2054622-001 Rev J © 2015 by General Electric Company. All rights reserved.


Illustrated Parts

7.8 Hardware Assembly















Figure 7-7 : 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

© 2015 by General Electric Company. All rights reserved. 2054622-001 Rev J 65


Illustrated Parts

7.9 Product Labels


Label on the lower lamp enclosure

Figure 7-8 : Printed symbols and warnings on Lamp Upper Enclosure

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

66 2054622-001 Rev J © 2015 by General Electric Company. All rights reserved.


Illustrated Parts
Labels on the back panel of the Lamp enclosure

Figure 7-9 : 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

Location of
rating label
Figure 7-10 : Labels and printing on Lamp Lower Enclosure
Label Label Description on Lower Lamp enclosure

Maintain minimum distance of 35 cms between


1
the light source and the patient label


© 2015 by General Electric Company. All rights reserved. 2054622-001 Rev J 67
Illustrated Parts
This page is left blank intentionally.

68 2054622-001 Rev J © 2015 by General Electric Company. All rights reserved.


Appendix A: Specifications

NOTE: The specifications are subject to change without notice


Specifications
Device Input : 45 VA @ 100-240V~ 50/60Hz
Lamp Unit I/P : 24V/1.0A (SMPS O/P)

Over temperature protection Power cutoff at temperature greater than or equal to 85°C

Less than 100uA at mains power (100-240Vac) during


normal condition
Touch current
Less than 500uA at mains power (100-240Vac) during
single fault condition.

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)

© 2015 by General Electric Company. All rights reserved. 2054622-001 Rev J 69


Appendix A

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; UL 60601-1:2003
R6.03; CAN/CSA-C22.2 No. 601.1 - M90; CAN/CSA-C22.2 No.
60601-2-50-03 (2007); IEC 60601-1:2005; IEC 60601-2-50:
2009; EN 60601-1:2006; EN 60601-2-50: 2009
EMC Class -A, CISPR 11, Certified under IECEE CB scheme
Group 1

70 2054622-001 Rev J © 2015 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 surface
W) (cm) (µW/ cm2/nm) 15) (µW/ cm2/nm )
(cm)

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

© 2015 by General Electric Company. All rights reserved. 2054622-001 Rev J 71


Appendix B

Figure B-2 : Spectral Irradiance Vs Distance

Figure B-3 : Spectral Response Curve

72 2054622-001 Rev J © 2015 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 %.

© 2015 by General Electric Company. All rights reserved. 2054622-001 Rev J 73


Appendix C

Immunity Test EN 60601 Test Compliance Level Electromagnetic


Level Environment -
Guidance
±2kV for power ±2kV for power
supply lines supply lines Mains power quality
Electrical fast
should be that of
transient/burst EN
a typical hospital
61000-4-4 ± 1kV for input/ ± 1kV for input/ environment.
output lines output lines
± 1kV differential ± 1kV differential
mode mode Mains power quality
Surge EN 61000- should be that of
4-5 a typical hospital
± 2kV common ± 2kV common environment.
mode mode
<5% UT (>95% dip <5% UT (>95% dip
in UT ) for 0.5 cycles in UT ) for 0.5 cycles Mains power should
be that of a typical
hospital environment. If
40% U (60% dip in 40% UT (60% dip in the equipment requires
Voltage dips, short T
UT ) for 5 cycles UT ) for 5 cycles continued operation
interruptions and
during power mains
voltage variations
interruptions, it is
on power supply 70% UT (30% dip in recommended that
input lines EN 70% UT (30% dip in
UT ) for 25 cycles the Lullaby LED
61000-4-11 UT ) for 25 cycles
Phototherapy be
powered from an
<5% UT (>95% dip uninterrupted power
<5% UT (>95%
in U ) for 5 seconds supply.
dip in UT ) for 5 T
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 fields should
magnetic field EN be at levels of a typical
61000-4-8 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

74 2054622-001 Rev J © 2015 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
(W)

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.

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.

© 2015 by General Electric Company. All rights reserved. 2054622-001 Rev J 75


Appendix C

C.2 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.

76 2054622-001 Rev J © 2015 by General Electric Company. All rights reserved.


Appendix D: Wiring Diagram

© 2015 by General Electric Company. All rights reserved. 2054622-001 Rev J 77


Appendix D

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78 2054622-001 Rev J © 2015 by General Electric Company. All rights reserved.


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

Black on white
A5 paper size
Two (2) sides print
Coil Binding
Made in India Printed in India

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