GE Lullaby Phototherapy System User and maintenance manual
GE Healthcare
Lullaby™
LED Phototherapy System
Operation and Maintenance Manual
Operation and Maintenance Manual
English
2051539-001
Rev F
© 2011 by General Electric Company. All
rights reserved.
© 2011 General Electric Company
All rights reserved. General Electric Company reserves the right to make changes in
specications 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.
Table of Contents
About this Manual......................................................................................................5
Chapter 1: Safety........................................................................................................9
Chapter 2: Product Description.............................................................................11
2.1 Features......................................................................................................................................11
2.3 Controls, Indicators, Mechanical controls...................................................................12
Chapter 3: Operating Procedure............................................................................15
3.1 Operating Instructions.........................................................................................................15
3.2 Checking equipment before use.....................................................................................15
3.3 Preparing an Infant for phototherapy..........................................................................15
3.4 Basic Operating Procedure................................................................................................16
3.5 Tilting the Lamp enclosure.................................................................................................19
3.6 Using with other devices.....................................................................................................19
3.7 Using Lamp enclosure in detached condition...........................................................21
Chapter 4: Troubleshooting....................................................................................23
Chapter 5: Cleaning and Maintaining...................................................................29
5.1 Cleaning ....................................................................................................................................29
5.2 Maintaining................................................................................................................................29
Appendix A: Specifications......................................................................................31
Appendix B: Technical Reference...........................................................................33
B.1 Effective Surface Area.........................................................................................................33
B.2 Service Maintenance............................................................................................................35
B.3 Part Replacement..................................................................................................................35
Appendix C: Electromagnetic Compatibility (EMC)............................................37
C.1 Electromagnetic Emission..................................................................................................37
C.2 CE Marking Information......................................................................................................39
C.3 Recommendation.............................................................................................40
Warranty...................................................................................................................41
© 2011 by General Electric Company. All rights reserved. 2051539-001 Rev F 3
Table of Contents
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4 2051539-001 Rev F © 2011 by General Electric Company. All rights reserved.
About this Manual
Scope
This manual provides a comprehensive description of the components of Lullaby LED
Phototherapy System and its operation and maintenance details.
Indications for Use
The Lullaby LED Phototherapy System is used for the treatment of indirect hyperbilirubinemia in term and pre-term infants, in a hospital environment – NICUs, PICUs and
Well-baby Nurseries - administered by trained, professional medical sta, on the order of a
licensed medical practitioner.
The Lullaby LED PT system is intended for use under the direct supervision of a licensed
healthcare practitioner.
The Lullaby LED PT system device is not intended to be operated in mobile vehicles
including ambulances or other vehicles associated with health care facilities.
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 benet
of the user to facilitate correct and eective application of the device.
Symbol Denition
The following table describes the symbols and its inferences.
Symbol Description
This symbol denotes “Caution, read accompanying documents.” This
applies also to when the Caution symbol appears on an equipment
q .
WARNING A WARNING statement is used when the possibility of injury exists.
© 2011 by General Electric Company. All rights reserved. 2051539-001 Rev F 5
label. It means additional information is found in the accompanying
documents.
A General Warning statement is used to inform the users of the
equipment on possible risk or injury.
About this Manual
Symbol Description
NOTE A NOTE provides additional information to clarify a point in the text.
Cover the patient’s eyes while administering phototherapy.
Over Temperature Cut-o Indicator
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
6 2051539-001 Rev F © 2011 by General Electric Company. All rights reserved.
Symbol Description
Refer to instruction manual/booklet
Do not move the incubator with the device on it.
Do not cover the vent
Prescription Device Label for United States.
About this Manual
© 2011 by General Electric Company. All rights reserved. 2051539-001 Rev F 7
About this Manual
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8 2051539-001 Rev F © 2011 by General Electric Company. All rights reserved.
Chapter 1: Safety
It is important to know and understand the safety measure 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.
WARNINGS
• Possible Risks: All phototherapy methods have possible risks including, but not limited
to, bronze baby syndrome, diarrhea, hyper-pigmentation, minor erythema, skin
reddening, skin blistering, and potential retinal damage. Monitor the patient closely for
signs of these conditions during phototherapy.
• Photo Isomers: Bilirubin photo isomers might cause toxic eects.
• Porphyrins: Porphyrins are the by-products of the photochemical break down of
the bilirubin molecule. In some cases, exposure of porphyrins to phototherapy could
result in a localized reddening of the patient's skin. Therefore, skin assessment is
recommended with all types of phototherapy per hospital policy.
• Photosensitive Drugs: The light generated can degrade photosensitive medications.
Do not place or store any drugs near or in the illuminated area.
• Dehydration and Insensible Water Loss: The radiant energy from phototherapy lights
can increase a patient's insensible water loss. Take appropriate measures to maintain
the patient's uid balance while administering phototherapy.
• Skin Temperature: Phototherapy light may aect the temperature in thermoregulation
devices (incubator, radiant warmers or heated mattresses) and could result in raising
the patient's body temperature when the device is in use. It is recommended to use
an incubator, warmer or bassinet in skin controlled (servo) mode. Always monitor the
patient's temperature to avoid temperature uctuations during phototherapy as per
hospital policy.
• Reective Foils: Using reective foils to increase the ecacy of phototherapy may
cause hazardous increase in patient’s body temperature.
• Eye Protection: Do not look directly into the lamps. During treatment, always protect
the patient’s eyes with protective eyewear. Periodically, as per hospital protocol, verify
that the patient’s eyes are protected and free of irritation.
• 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 eects.
• Regular monitoring: During treatment it is recommended to follow the measures as
specied in the following guidelines:
• Measure the patient’s bilirubin level periodically during treatment per hospital
guidelines.
• Turn o the light when checking the patient’s condition and skin color.
• Follow standard procedures for monitoring patient temperature and uid status.
• Verify that the patient’s eyes are protected and free of irritation as per hospital
guidelines.
• Maintain a distance of 35 cm between the light unit and the patient for optimal
light intensity.
© 2011 by General Electric Company. All rights reserved. 2051539-001 Rev F 9
Safety
• Adjusting Height: Do not adjust the height of the equipment with the patient directly
under the unit. Secure the light unit in position before placing the patient under the
device for therapy.
• Do not place the device in the path of any elevating bed.
• 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.
The LED Phototherapy system , as with any electrical equipment must be must be handled
with care to avoid damage to the equipment. Follow the below mentioned precautions with
regard to the device.
q CAUTION
• Following EMC Regulation: 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 aect Medical Electrical
Equipment.
• Environment: When using the Lullaby LED Phototherapy System adjacent to other
equipment, it is important to verify normal operation in the conguration in which
it is used.
• Do not use the Lullaby LED Phototherapy System in the presence of ammable
anesthetics or gases to prevent any possibility of explosion under these
conditions.
• When using the Lullaby LED Phototherapy System with Warmer ensure that the
Lamp enclosure is not in the heat path of the Warmer.
10 2051539-001 Rev F © 2011 by General Electric Company. All rights reserved.
Chapter 2: Product Description
The Lullaby LED Phototherapy System is intended to treat infants suering 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
3
Figure 2-1 : LED phototherapy System
2.1
2.2
2.3
11.2
2
2.4
2.5
2.6
2.7
2.8
3.1
1. Lamp Enclosure: The Lamp enclosure has
10 LED lamps enclosed in a plastic housing,
which forms the light source. It consists of
two parts- the upper enclosure and the lower
enclosure. The lamp enclosure can be tilted to
approximately 90° from the horizontal position.
1.1 Air-vent: The air vents provide ventilation to
the device when it is in use.
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
enclosure to the Arm (2.3). By removing
the knobs the Lamp enclosure can be
detached and used independently.
2.1 Tilt knob: This knob can be loosened to tilt
the lamp enclosure.
2.2 Securing Knob: The retaining knob secures
the lamp enclosure to the Arm (2.3).
2.3 Arm: The Arm is xed to the pedestal and
supports the lamp enclosure.
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
inner tube at the desired height.
2.6 Outer tube: This part is xed to the Base.
2.7 SMPS Holder: This part is attached to the
outer tube to place the SMPS (DC power
supply).
2.8 SMPS with power cord: The power unit with
power cables to supply power to the unit.
© 2011 by General Electric Company. All rights reserved. 2051539-001 Rev F 11
Product Description
Part Illustration
1.1
1.2
1
2
3
2.1
2.2
2.3
2.4
2.5
2.6
2.7
2.8
3.1
Function
3. Base Assembly: The base is designed to
provide stability at any height or angle of the
lamp enclosure.
3.1 Casters with brake: The swivel casters
add mobility to the device. The brakes
on each caster, when actuated, prevents
movement.
Note: To move the equipment hold the unit below
the height adjust lock.
2.3 Controls, Indicators, Mechanical controls
This section describes, in detail, the components of the Lullaby LED Phototherapy System.
2.3.1 Controls
DC Jack (Refer Figure 2-2): The device is powered
by a 24V SMPS. The power supply cable from the
SMPS is connected to the DC jack on the lamp
enclosure.
WARNING
1. The use of power cords and SMPS other than
those specied by the manufacturer might
aect the performance of the unit and could
result in damage to the unit.
Figure 2-2 : DC Jack
12 2051539-001 Rev F © 2011 by General Electric Company. All rights reserved.
2. It may also create an unsafe operating
condition, exposing a user to electric shock.
2
1
Figure 2-3 : Lamp enclosure
2.3.2 Indicators
Product Description
Power ON/OFF Switch (Refer 1 of Figure 2-3):
3
This switch turns ON and OFF the power supply to
the device.
WARNING
Disconnect the power cord to completely cut-o
the power supply to the device.
Irradiance Selection Switch (Refer 2 of Figure
2-3): The irradiance selection switch is used to
select light intensity-low or high irradiance.
Air Vent (Refer 3 of Figure 2-3): The air vents
helps to circulate the air inside the lamp enclosure
and maintain its temperature when in use.
WARNING
Ensure that the air vents are not covered or
obstructed when the unit is being used.
Over Temperature Cut-O Indicator (Refer
Figure 2-4): This indicator glows when the device
shuts down due to over temperature (exceeds
85°C) inside the lamp enclosure.
NOTE: In normal operating condition this indicator
is OFF.
Figure 2-4 : Over temperature cut-o
indicator
Lamp Life Timer (Refer Figure 2-5): The Lamp
life timer indicates the number of hours the LED
lamps have been used.
NOTE: GEHC recommends, replacing the lamp
after 50000 hours.
Figure 2-5 : Lamp life timer
© 2011 by General Electric Company. All rights reserved. 2051539-001 Rev F 13
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