GE Lullaby Phototherapy System User and maintenance manual

4.8 (6)

GE Healthcare

Lullaby™

LED Phototherapy System

Operation and Maintenance Manual

Operation and Maintenance Manual English

2051539-001 Rev F

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.

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 detachedcondition...........................................................	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

2051539-001 Rev F

Table of Contents

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2051539-001 Rev F

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 staff, 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 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.

2051539-001 Rev F

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-off 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

2051539-001 Rev F

GE Lullaby Phototherapy System User and maintenance manual

About this Manual

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.

2051539-001 Rev F

About this Manual

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2051539-001 Rev F

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 effects.

•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 fluid balance while administering phototherapy.

•Skin Temperature: Phototherapy light may affect 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 fluctuations during phototherapy as per hospital policy.

•Reflective Foils: Using reflective foils to increase the efficacy 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 effects.

•Regular monitoring: During treatment it is recommended to follow the measures as specified in the following guidelines:

•Measure the patient’s bilirubin level periodically during treatment per hospital guidelines.

•Turn off the light when checking the patient’s condition and skin color.

•Follow standard procedures for monitoring patient temperature and fluid 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.

2051539-001 Rev F

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.

qCAUTION

•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 affect Medical Electrical

Equipment.

•Environment: When using the Lullaby LED Phototherapy System adjacent to other equipment, it is important to verify normal operation in the configuration in which it is used.

•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.

•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 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

1.12.1

2.2

2.3

1.2	1	2.4
		2.5

2.6

2.7

2.8

3.1

Figure 2-1 : LED phototherapy System

Function

1.Lamp Enclosure: The Lamp enclosure has 10 LED lamps enclosed in a plastic housing, which forms the light source. It consists of two partsthe upper enclosure and the lower enclosure. The lamp enclosure can be tilted to approximately 90° from the horizontal position.

1.1Air-vent: The air vents provide ventilation to the device when it is in use.

1.2Handle: 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.

2.1Tilt knob: This knob can be loosened to tilt the lamp enclosure.

2.2Securing Knob: The retaining knob secures the lamp enclosure to the Arm (2.3).

2.3Arm: The Arm is fixed to the pedestal and supports the lamp enclosure.

2.4Inner tube: This part supports the Arm (2.3). The inner tube can be adjusted to vary the height of the lamp enclosure.

2.5Height Adjust Lock: This part secures the inner tube at the desired height.

2.6Outer tube: This part is fixed to the Base.

2.7SMPS Holder: This part is attached to the outer tube to place the SMPS (DC power supply).

2.8SMPS with power cord: The power unit with power cables to supply power to the unit.

2051539-001 Rev F

2.2

2.3

2.4

Product Description

Part Illustration

1.1 2.1

1.21

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

2.5on each caster, when actuated, prevents movement.

2.6Note: To move the equipment hold the unit below the height adjust lock.

2.7

2.8

3.1

2.3 Controls, Indicators, Mechanical controls

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

2.3.1 Controls

DC Jack (Refer Figure 2-2): The device is powered by a 24V SMPS. The power supply cable from the SMPS is connected to the DC jack on the lamp enclosure.

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


12	2051539-001 Rev F	© 2011 by General Electric Company. All rights reserved.

Product Description

		Power ON/OFF Switch (Refer 1 of Figure 2-3):
	3	This switch turns ON and OFF the power supply to
	3	the device.
		the device.

		WARNING
		Disconnect the power cord to completely cut-off
		the power supply to the device.
		Irradiance Selection Switch (Refer 2 of Figure
		2-3): The irradiance selection switch is used to
2	1	select light intensity-low or high irradiance.
2	1	Air Vent (Refer 3 of Figure 2-3): The air vents
		Air Vent (Refer 3 of Figure 2-3): The air vents

	Figure 2-3 : Lamp enclosure	helps to circulate the air inside the lamp enclosure
	Figure 2-3 : Lamp enclosure	and maintain its temperature when in use.
		and maintain its temperature when in use.
		WARNING
		Ensure that the air vents are not covered or
		obstructed when the unit is being used.

2.3.2 Indicators

Over Temperature Cut-Off Indicator (Refer Figure 2-4): This indicator glows when the device shuts down due to over temperature (exceeds 85°C) inside the lamp enclosure.

NOTE: In normal operating condition this indicator is OFF.

Figure 2-4 : Over temperature cut-off indicator

Lamp Life Timer (Refer Figure 2-5): The Lamp life timer indicates the number of hours the LED lamps have been used.

NOTE: GEHC recommends, replacing the lamp after 50000 hours.

Figure 2-5 : Lamp life timer

2051539-001 Rev F

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