Professional Documents
Culture Documents
Lullaby™
LED Phototherapy System
Maintenance and Service Manual
CAUTION
The procedure described in this service manual should be performed by trained and
authorized personnel only.Maintenance should only be undertaken by a competent
individual who has general knowledge of and experience with devices of this nature. No
repair should ever be undertaken or attempted by anyone not having such qualifications.
Genuine replacement parts manufactured or sold by GE Healthcare must be used for all
repairs. Read completely through each step in every procedure; any exceptions may result
in failure to properly and safely complete the attempted procedure. After repair, test the
equipment to ascertain that it complies with the published specifications
Do not use malfunctioning equipment. If the unit is under warranty, contact GE Healthcare
technical support at the number given at back of the manual PRIOR to performing any
repair on the unit.
w
GE Healthcare has declared that this product confirms with the European Council Directive
93/42/EEC Medical Device Directive when it is used in accordance with the instructions
provided in the Maintenance and service Manual.
This symbol indicates that the waste of electrical and electronic equipment must not
be disposed as unsorted municipal waste and must be collected separately. Please
contact an authorized representative of the manufacturer for information concerning the
decommissioning of your equipment.
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.
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
WARNING:
HOIATUS
ATTENTION
• Si le technicien d’un client a besoin de ce manuel dans une langue autre que
(FR)
l’anglais, il incombe au client de le faire traduire.
• Ne pas tenter d’intervenir sur les équipements tant que ce manuel d’installation et
de maintenance n’a pas été consulté et compris.
• Le non-respect de cet avertissement peut entraîner chez le technicien, l’opérateur
ou le patient des blessures dues à des dangers électriques, mécaniques ou autres.
WARNUNG
• 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
(HU)
a fordítás elkészíttetése.
• Ne próbálja elkezdeni használni a berendezést, amíg a karbantartási kézikönyvben
leírtakat nem értelmezték.
• Ezen figyelmeztetés figyelmen kívül hagyása a szolgáltató, működtető vagy a beteg
áramütés, mechanikai vagy egyéb veszélyhelyzet miatti sérülését eredményezheti.
AÐVÖRUN
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
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!
• Ako klijentov serviser zahteva neki drugi jezik, klijent je dužan da obezbedi
(SR)
prevodilačke usluge.
• Ne pokušavajte da opravite uređaj ako niste pročitali i razumeli ovo servisno
uputstvo.
• Zanemarivanje ovog upozorenja može dovesti do povređivanja servisera, rukovaoca
ili pacijenta usled strujnog udara ili mehaničkih i drugih opasnosti.
UPOZORNENIE
ATENCION
VARNING
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 5: Troubleshooting...........................................................................................37
Chapter 6: Replacement Procedures...........................................................................47
6.1 Preliminary Operation....................................................................................................................47
6.2 Replacing parts in Lamp Enclosure..........................................................................................48
Warranty...............................................................................................................................83
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
All phototherapy methods have possible risks, therefore it is important to know and
understand the safety measures to be followed before using the phototherapy device. The
precautions mentioned below are to prevent possible risk of injury to the patient or the
operator and ensure correct usage of the equipment.
Note: This service manual is available only in English.
1.1 WARNING
• No modification of this equipment is allowed. Do not modify this equipment
without authorization of the manufacturer. If this equipment is modified,
appropriate inspection and testing must be conducted to ensure continued safe
use of the equipment.
• Unplug the power cord from the mains before opening the device for service.
• Do not lean against the side of LED Phototherapy system as it may cause it to tip
over.
• This device is for professional use only.
• Hot surface : The lens surface on the lamp enclosure assembly could be as hot as
70 °C during operation. Do not touch the lens when the lamps are in ON condition.
• Do not place lamp unit directly under any heat source such as a Radiant Warmer.
• No repair should ever be taken by unqualified personnel.
• To avoid over heating, do not cover any of the vents.
• Do not use the Lullaby LED Phototherapy System in the presence of flammable
anesthetics or gases to prevent any possibility of explosion under these
conditions.
The Lullaby LED Phototherapy System, as with any other electrical equipment, must
be handled with care to avoid damage to the equipment. Follow the below mentioned
precautions with regard to the device.
1.2 CAUTION q
• Servicing of this product in accordance with the service manual should never be
undertaken without the proper tools, test equipment, and the most recent revision
of the service manual, which has been clearly and thoroughly understood.
• Detailed drawings and the procedures for more extensive repairs are included
herein solely for service personnel having proper knowledge, tools, and test
equipment, and for service representative specially trained by GE Healthcare.
• To ensure the proper operation and light intensity, replace the LED Lamp only with
GE Healthcare replacement lamps.
• Use only the SMPS and power cord provided with the device to power the device.
• Operator Safety: Users may experience headache, nausea or mild vertigo if
the user remains in the irradiated area for a prolonged period of time. Using the
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.
The Lullaby LED Phototherapy System is intended to treat infants suffering from neonatal
hyperbilirubinemia, commonly known as neonatal jaundice. This section describes, in brief, the
various parts of the Lullaby LED Phototherapy System.
NOTE: Before using this device read the safety information.
2.1 Features
The Lullaby LED Phototherapy System consists of the Lamp enclosure, Pedestal Assembly and
Base assembly.
Part Illustration Function
1.1 1. Lamp Enclosure: The Lamp enclosure has
2.1
2.2 10 LED lamps enclosed in a plastic housing,
2.3 which forms the light source. It consists of
two parts- the upper enclosure and the lower
1.2 1 2.4 enclosure. The lamp enclosure can be tilted to
2.5 approximately 90° from the horizontal position.
1.1 Air-vent: The air vents provide ventilation to
2.6 the device when it is in use.
2 1.2 Handle: Depression provided on either side
to help hold the Lamp enclosure.
2. Pedestal Assembly: The pedestal consists of
the following parts:
• Knobs: The knobs secure the Lamp
2.7 enclosure to the Arm (2.3). By removing
the knobs the Lamp enclosure can be
2.8
detached and used independently.
2.1 Tilt knob: This knob can be loosened to tilt
the lamp enclosure.
3 2.2 Securing Knob: The retaining knob secures
the lamp enclosure to the Arm (2.3).
2.3 Arm: The Arm is fixed to the pedestal and
supports the lamp enclosure.
3.1
2.4 Inner tube: This part supports the Arm (2.3).
The inner tube can be adjusted to vary the
height of the lamp enclosure.
2.5 Height Adjust Lock: This part secures the
Figure 2-1 : LED phototherapy System inner tube at the desired height.
2.6 Outer tube: This part is fixed to the Base.
2.7 SMPS Holder: This part is attached to the
outer tube to place the SMPS (DC power
supply).
2.8 SMPS with power cord: The power unit with
power cables to supply power to the unit.
2.7
2.8
3.1
2.3.1 Controls
WARNING
Ensure that the air vents are not covered or
obstructed when the unit is being used.
2.3.2 Indicators
Over Temperature Cut-Off Indicator (Refer
Figure 2-4): This indicator glows when the device
shuts down due to over temperature (exceeds
85°C) inside the lamp enclosure.
NOTE: In normal operating condition this indicator
is OFF.
WARNING
Always support the lamp enclosure with one hand
when releasing the lock to adjust the height.
WARNING:
Installation must be carried out by qualified service personnel. Before assembling the
Lullaby LED Phototherapy System and administering phototherapy, carefully read all
sections of this manual.
Description Quantity
Lamp enclosure 1
Outer tube assembly 1
Inner tube assembly 1
Base assembly 1
Lower Arm 1
Upper Arm 1
SMPS 1
SMPS Holder 1
Power Cord 1
Fastener Kit 1
Operation & Maintenance Manual 1
Maintenance & Service Manual 1
Top cover
Height lock
Outer tube
SMPS holder Inner tube
Upper & Lower arm
Base
SMPS
Foam
Lamp
enclosure
Box
WARNING
The LED Phototherapy system should not be subjected to outdoor transport, in the
assembled condition.
Base
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 3-10 : DC jack
SMPS
AC power cord
point
Note : After the installation of the device service check out procedure per section 4.3 of this
manual shall be performed.
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. Ensure that the Height lock is tightened thoroughly.
2. Maintain the minimum distance of 35 cms between
the patient and the Lamp enclosure.
WARNING
1. Always support the Lamp enclosure with
one hand when loosening or tightening the
knob.
Figure 3-14 : Front knob
2. Ensure that the knob is tightened
thoroughly.
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
q CAUTION
Detailed information for more extensive repairs is included in this manual solely for the
convenience of users having proper knowledge, tools, and test equipment, and for service
representatives trained by GE Healthcare.
WARNING
Do not perform any checkout procedure with the patient under the unit. If the equipment
fails any of the checkout procedure it must be removed from use and replaced.
q CAUTION
Always use the personnel protection equipment when installing, dismantling,
q CAUTION
It is important to check the electrical safety test and light intensity measurement procedure
to assure that the unit is functioning properly at the time of servicing.
4.3.2.3 Lamp Life Timer
The Lamp Life timer indicates the number of hours the lamp has been used.
1. Connect the power cord and turn ON the unit.
2. Check if the timer is ON. Check the Lamp life timer increments after 6 minutes to
ensure the counter working.
4.4 Maintenance
The Lullaby LED Phototherapy System should be maintained in accordance with the
preventative maintenance procedures detailed in this manual. Service maintenance must
be performed by a technically competent individual.
This chapter lists the possible LED Phototherapy System symptoms as well as the possible
causes and solutions. For any necessary part replacements or adjustments, follow the
instructions provided in Chapter 6. Always read all the warnings, cautions, notes, and
other information provided in “ Safety” section starting on page 15 before starting any
troubleshooting. The following flowcharts describe likely symptoms, their causes and
actions to be taken.
A - Damaged parts
B - Jammed Parts
C- Functionality Issues
A: Damaged Parts
Y
A2- Lower enclosure of the Enclosure,
Remove the unit
Replace with the from service
Enclosure and
Assembly
Lamp is damaged contact GE-authorized
Lamp lower, and trained
FRU No. 2053645-001
service personnel.
A3- Heat sink, MCPCB, Lens,LED is Y Replace with the Heat sink, MCPCB,
damaged Lens,LED ,FRU No. 2053651-001
Y
A4-Driver Board is damaged Replace with Driver Board , FRU No.
2053653-001
A6-Base assembly unit is damaged Y Replace with Base Assembly, FRU No.
2053657-001
A8-Power cord is damaged Y Order for country specific cord from the
kit
Y
A9-Caster is damaged Replace with Caster FRU No.2053662-
001
e
Y
A11-Plastic ring is damaged Replace the Plastic ring with Hardware
FRU No. 2053665-001
B: Jammed Parts
n
Y The knob may be over tightened-try
B1- Lamp enclosure cannot be tilted to release and tighten.
C:Functionality Issues
C1- Lamp unit overheat indicator is Y Turn off the mains switch and
ON disconnect the power cord from the
outlet.
C2- Blue LED light not illuminating Y Check if the Over temperature cut-off
indicator is glowing.
N Y
N Y
C3-Lamp life timer is not functioning Y Check if the blue LED lamps are glowing
N
Replace LED Driver to Lamp Hour Meter Check the LED Driver to Lamp Hour Meter
Assembly from FRU Harness Assembly Harness assembly continuity is available.
Kit 2054787-001
N
Check if the Over Temperature cut off red LED
is illuminating.
C4- Unit will not power ON Remove the DC Plug from the Unit and
measure the voltage and confirm that
the voltage is within 24V ± 1VDC.
WARNING
Before performing any replacement do the following:
1. Always use anti-static material and wear anti-static wrist strap.
2. It is recommended to use safety glasses, safety shoes and safety gloves before
servicing the equipment.
3. Unplug the power supply cord.
4. Set the caster brakes (except when the base or casters require replacement).
CAUTION
The procedures described in this chapter should be performed by trained and authorized
personnel only. Genuine replacement parts sold by GE Healthcare must be used for all
repairs. Read through each step in every procedure before starting, any replacements.
Instructions
1. If the Lamp enclosure is warm, wait for it to cool down before performing any repair.
2. Prepare the following equipment:
• Phillips Screwdriver capable of removing and tightening 4 mm and 6mm screws
(they are preferably torque adjusted)
• Flat blade screwdrivers
Description
Slot Head Screwdriver
Phillips Screw driver #1
Torque wrench - range 2Nm - 8Nm
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
CAUTION
While replacement, ensure the lens is properly fixed on to the Metal Clad PCB and there is
no damage observed on the lens surface.
Switch rocker
Lamp hour timer
3. Unscrew the SMPS holder on the Outer tube with the 2.5 mm hex keys and remove
the M4 Screw, M4 Spring washer, M4 Flat washer and keep it aside, as shown in Figure
6-11.
Base
M6 Screw
Inner tube
Slide inner
M6 Flat washer
M6 Screw
Suspension spring
pedestal
Outer tube
SMPS holder
Base
Caster
M10 Screw
2. Replace the caster and tighten the bolt using the 8mm hex key.
6.2.10 Replacing the Lower arm
1. Remove the upper arm cover as described in section 6.2.1 (Removing the Upper arm).
2. Remove the Lamp enclosure and keep it in a safe place.
Pin 1
Pin 2
Figure 6-18 : Lamp hour timer
J2 J3
MCPCB
Harness
CAUTION
While replacement, ensure the lens is properly fixed on to the Metal Clad PCB and there is
no damage observed on the lens surface.
J5 J6
Pin 1
2 Pin
Pin 2 1 Pin
Pin 1 Pin 4
Pin 4 Pin 1
J2 J3
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
10 Enclosure, Lamp Lower 1
13 Screw cap 5
ENCLOSURE, LAMP
2053645-001 12 M4 Screw 5
LOWER FRU KIT
11 M4 Flat washer 5
14 M3X 6 CSK skt flat head Screw 1
1 Enclosure Assy , Lamp Upper 1
13 Screw cap 5
ENCLOSURE ASSY ,
2053648-001 12 M4 Screw 5
LAMP UPPER FRU KIT
11 M4 Flat washer 5
14 M3X 6 CSK skt flat head Screw 1
Heat Sink, MCPCB Assembly,
5 1
XPE
6 Label, Hot surface 1
7.2 Pedestal
7.3 Base
7.5 Power
7.6 Caster
Figure 7-7 : Harness Assembly
Service Part/FRU Service Part/Kit
Item # Part Description Qty
KIT Number Description
Harness Assembly XPE, PWA
1 to MCPCB
2
3 DC Current label
4 Irradiance indicator
6 ON/OFF switch
Following is the block diagram of the electrical system of the light unit.
Performance Specifications
Physical Specification
Overall dimension (Lx Bx H) 530 mmx 550 mmx 1700 mm (at maximum height)
Regulatory Standards
IEC Class 1 (continuous TÜV Rheinland CB certified to the following standards: IEC
operation) 60601-2-50; IEC 60601-1; IEC 60601-1-2
EMC Class -A, CISPR 11, Certified under IECEE CB scheme
Group 1
35 50 x 30 45 35
40 50 x 30 40 31
50 50 x 30 31 25
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.3 Recommendation
Users should be aware of known RF sources, such as radio or TV stations and hand-held or
mobile two-way radios, and consider them when installing a medical device or system. Be
aware that adding accessories or components, or modifying the medical device or system
may degrade the EMI performance. Consult with qualified personnel regarding changes to
the system configuration.
Operating the system near radio frequency (RF) electromagnetic interference (EMI) above
the conditions defined in the EMC Standard EN60601-1-2 for Radiated Immunity (field
strengths above 3 V/m) may cause malfunctions.
Medical Electrical Equipment needs special precautions regarding EMC and needs to
be installed and put into service according to the EMC information provided in this
manual. Review the AAMI Committee Technical Information Report (TIR) 18, “Guidance on
Electromagnetic Compatibility of Medical Devices for Clinical/Biomedical Engineers”. This
guidance document provides a means to evaluate and manage the EMI environment in the
hospital. The following actions can be taken to reduce the risk of medical device EMI and
achieve EMC:
• Assess the EMC environment of the healthcare facility (e.g., identify radio
transmitters in around the facility) and identify areas where critical medical
devices are used (e.g., ER, ICU, CCU, NICU).
• Increase the distance between sources of EMI and susceptible devices.
• Remove the devices that are highly susceptible to EMI.
• Lower the power transmitted from electrical and electronic equipment (EMI
sources) under hospital control (i.e. paging systems).Label devices susceptible to
EMI.
• Educate healthcare facility staff (nurses and doctors) to be aware of, and to
recognize, potential EMI related problems.
Notes
Description Number
Serial number of the unit
NOTE: For the serial number of the device, refer to the rating label on the Lamp assembly.
Record the serial number of the device in the space provided above for reference.
82 2054622-001 Rev E © 2011 by General Electric Company. All rights reserved.
Warranty
This Product is sold by GE Healthcare under the warranties set forth in the following
paragraphs. Such warranties are extended only with respect to the purchase of this Product
directly from GE Healthcare or GE Healthcare’s Authorized Dealers as new merchandise
and are extended to the Buyer thereof, other than for the purpose of resale. For a period
of twelve (12) months for the light unit from the date of original delivery to Buyer or to
Buyer’s order, but in no event for a period of more than two years from the date of original
delivery by GE Healthcare to a GE Healthcare Authorized Dealer, this Product, other than
its expendable parts, is warranted to be free from functional defects in materials and
workmanship and to conform to the description of the Product contained in this operation
manual and accompanying labels and/or inserts, provided that the same is properly
operated under the conditions of normal use, that regular periodic maintenance and
service is performed and that replacements and repairs are made in accordance with the
instructions provided.
The foregoing warranties shall not apply if the Product has been repaired other than by
GE Healthcare or in accordance with written instructions provided by GE Healthcare, or
altered by anyone other than GE Healthcare, or if the Product has been subject to abuse,
misuse, negligence, or accident. GE Healthcare’s sole and exclusive obligation and Buyer’s
sole and exclusive remedy under the above warranties is limited to repairing or replacing,
free of charge, at GE Healthcare’s option, a Product, which is telephonically reported to the
nearest GE Healthcare Regional Service Office and which, if so advised by GE Healthcare,
is thereafter returned with a statement of the observed deficiency, not later than seven (7)
days after the expiration date of the applicable warranty, to the designated GE Healthcare
Service Center during normal business hours, transportation charges prepaid, and which,
upon GE Healthcare’s examination, is found not to conform with above warranties. GE
Healthcare shall not be otherwise liable for any damages including but not limited to
incidental damages, consequential damages, or special damages. There are no express
or implied warranties, which extend beyond the warranties hereinabove, set forth. GE
Healthcare makes no warranty of merchantability or fitness for a particular purpose with
respect to the product or parts thereof.
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