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Lullaby LED PT Service Manual
Lullaby LED PT Service Manual
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.
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
• 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.
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
• 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:
HOIATUS
• 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.
ATTENTION
• 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
• 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
• 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.
• 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
AVVERTENZA
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。
BRĪDINĀJUMS
ĮSPĖJIMAS
• 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
• 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
• 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.
ATENÇÃO
• 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
• 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!
UPOZORENJE
• 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.
ATENCION
VARNING
OPOZORILO
DİKKAT
• 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.
Chapter 4: Calibration����������������������������������������������������������������������������������������������������39
Chapter 5: Troubleshooting������������������������������������������������������������������������������������������41
Chapter 6: Replacement Procedures���������������������������������������������������������������������������49
6.1 Preliminary Operation������������������������������������������������������������������������������������������������������������������� 49
Appendix A: Specifications�������������������������������������������������������������������������������������������������69
Appendix B: Technical Reference��������������������������������������������������������������������������������������71
B.1 Effective Surface Area������������������������������������������������������������������������������������������������������������������������� 71
B.1.1 Spectral Irradiance vs Distance��������������������������������������������������������������������������������������� 71
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.
Symbol Description
Power OFF
Power ON
Low Irradiance
High Irradiance
WEEE Symbol
CE Mark
DC Current
Symbol Description
To indicate mass
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.
When grouped, cautions and warnings are listed alphabetically and do not imply any order
of importance.
Do not lean against the side of LED Phototherapy system as it may cause it
to tip over.
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.
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.
Effect of blue light: Blue light can hinder clinical observations by masking skin
color changes, such as cyanosis.
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.
Medical Electrical Equipment needs to be installed and put into service strictly
according to the EMC information provided in this manual.
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.
2.7
2.8
3.1
1.3.1 Controls
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.
WARNING
Always support the lamp enclosure with one hand
when releasing the lock to adjust the height.
Top Foam
Outer Tube
SMPS
SMPS holder
Inner Tube
Base
Lamp
enclosure Bottom Foam
Box
End Fitting
(Dead Weight)
M6 Screws
Clearance in Slide
inner
Welded seam on
Outer tube
:
Lamp
Instructions to fix the Lamp
enclosure enclosure on the Lower arm
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
Note : Upon completing the installation, perform the checkout procedures as described in
“Chapter 3”.
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.
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.
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.
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.
*Lamp unit must not be tilted without the knobs being loosened. It could result in cracking of the lamp
enclosure and the tilt mechanism
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.
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
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
Inner tube
Inner tube
Slide inner
M6 Flat washer
M6 Screw
SMPS
holder
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).
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).
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.
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
Knobs
Upper arm
Lamp enclosure
Horizontal hinge
Lower arm
Figure 6-2 : Removing the Lamp enclosure from the Lower arm
Upper enclosure
Screw
Lower enclosure
Screw Cap
M3 Screw
M4 Screw
Lower
enclosure
M3 Flat washer
Driver board
M4 Screw
While replacement, ensure the lens is properly fixed on to the Metal Clad PCB
and there is no damage observed on the lens surface.
Base
Caster
M10 Screw
3. Remove the M4 cap screw and M4 flat washer to remove the lower arm from the inner
tube.
M4 Screw
Pin 1
Pin 2
Figure 6-12 : Lamp hour timer
MCPCB J2 J3
Harness
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
Switch rocker
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.
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
7.2 Base
7.4 Power
7.5 Caster
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
3 DC Current label
4 Irradiance indicator
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
© 2015 by General Electric Company. All rights reserved. 2054622-001 Rev J 67
Illustrated Parts
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Over temperature protection Power cutoff at temperature greater than or equal to 85°C
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; 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
35 50 x 30 45 35
40 50 x 30 40 31
50 50 x 30 31 25
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.
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.
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
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.
EC Representative
GE Medical Systems SCS
283 Rue de la Minière
78530 BUC
FRANCE
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