GE Lullaby Operation and Maintenance Manual Rev C 2011

© 2011 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.

Table of Contents

About this Manual... 5 Chapter 1: Safety... 7 Chapter 2: Product Description... 9 2.1 Features... 9 2.3 Controls, Indicators, Mechanical controls... 10

Chapter 3: Operating Procedure... 13 3.1 Operating Instructions... 13 3.2 Checking equipment before use... 13 3.3 Preparing an Infant for phototherapy... 13 3.4 Basic Operating Procedure... 14 3.5 Tilting the Lamp enclosure... 17 3.6 Using with other devices... 17 3.7 Using Lamp enclosure in detached condition... 19

Chapter 4: Troubleshooting... 21 Chapter 5: Cleaning and Maintaining... 27 5.1 Cleaning ... 27 5.2 Maintaining... 27

Appendix A: Specifications... 29 Appendix B: Technical Reference... 31 B.1 Effective Surface Area... 31 B.2 Service Maintenance... 33 B.3 Part Replacement... 33

Appendix C: Electromagnetic Compatibility (EMC)...35 C.1 Electromagnetic Emission... 35 C.2 CE Marking Information... 37 C.3 Recommendation... 37

Warranty... 39

© 2011 by General Electric Company. All rights reserved.

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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

q

This symbol denotes “Caution, read accompanying documents.” This 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

© 2011 by General Electric Company. All rights reserved.

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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

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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. 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.

© 2011 by General Electric Company. All rights reserved.

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Safety

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 • • • • •

8

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.

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© 2010 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

Function

1.1

2.1

2.2 2.3

1.2

2.4

1

2.5 2.6 2

2.7 2.8

3

3.1 Figure 2-1 : LED phototherapy System

© 2011 by General Electric Company. All rights reserved.

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 fixed 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 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.

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Product Description

Part Illustration

Function

1.1

2.1

3. Base Assembly: The base is designed to provide stability at any height or angle of the lamp enclosure. 2.2

3.1 Casters with brake: The swivel casters add mobility to the device. The brakes on each caster, when actuated, prevents movement.

2.3 1.2

2.4

1

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

2.5 2.6 2

2.7 2.8

3

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

Figure 2-2 : DC Jack

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. 2. It may also create an unsafe operating condition, exposing a user to electric shock.

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Product Description

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Power ON/OFF Switch (Refer 1 of Figure 2-3): This switch turns ON and OFF the power supply to 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 select light intensitylow or high irradiance.

2

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. 1

Figure 2-3 : Lamp enclosure

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 on 30% reduction of irradiance or after 20000 hours.

Figure 2-5 : Lamp life timer

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Product Description

2.3.3 Mechanical Controls Height Adjust Lock (Refer Figure 2.6): 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 2-6 : Height adjust lock

SMPS Holder (Refer Figure 2-7): The holder is fixed to the outer tube to support the SMPS (power supply unit). To DC Jack

SMPS

SMPS (Refer to Figure 2-7): The power supply unit is connected with power cables. The cable is connected to the DC jack, on the Lamp enclosure, at one end and to the AC power source on the other. CAUTION

SMPS Holder

Wrap the excess cord around the SMPS holder to avoid the cord from trailing when moving or using the device.

To AC Power source

Figure 2-7 : SMPS with power cables in SMPS holder

Base (Refer Figure 2-8): The base keeps the device unit in a stable position. Casters with position lock (Refer Figure 2-9): 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 2-8 : 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 2-9 : Caster with brake lever

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© 2011 by General Electric Company. All rights reserved.

Chapter 3: Operating Procedure

The following section describes the operating procedure of the device. For detailed instructions on installing and setup refer to Chapter 3 : Installing and Setup, in Service manual ( 2054622-001).

3.1 Operating Instructions The following section provides step-by-step instructions to ensure that the Lullaby LED Phototherapy System provides effective phototherapy treatment: • • • • •

Read this manual and all accompanying documents. Note the WARNING and CAUTION statements that appear in this manual and all accompanying documents. Read the User Responsibility Statement available in the beginning of this manual. Read the Warranty: It describes GE Healthcares’ responsibility in case of a functional defect. Keep this manual and all accompanying documents for future reference.

3.2 Checking equipment before use Before using the equipment inspect for the following: • • • • • •

Examine the power cord and the light unit for obvious signs of damage. If damaged, do not put the unit in use and contact GE authorized, service personnel. Verify that air circulation vents on the light unit are not covered or obstructed. Check for the power supply, connect the power supply cord to the DC Jack on the light unit and the other end to the main power supply. Wrap the power cord around the SMPS holder to prevent tripping. Test the lamps, turn On the lamp On/Off switch on the rear end of the Lamp enclosure. Turn on the irradiance selection switch and observe the lamp illumination. Use the Ohmeda Medical Biliblanket Meter II to check the irradiance level. Ensure the light unit is securely locked to the pipe and the pedestal assembly. The light unit can be tilted to a maximum of 90° angle from the horizontal axis of the pedestal. Test the tilting mechanism. Ensure that the brakes on the wheel are actuated.

If any of the above activity does not perform as described , do not use the unit. Contact qualified service personnel.

3.3 Preparing an Infant for phototherapy After completing the checkout procedures on the equipment it is important to follow the below mentioned procedures to get the maximum benefit of the treatment: 1. Remove the infant clothing. Leaving the diaper on is at the discretion of the attending physician. 2. Maximize skin surface area to be exposed to phototherapy treatment. 3. Cover the eyes of the infant using an appropriate eye shield. 4. If the baby has a skin temperature probe in place, ensure this is appropriately applied to the infants skin and cover with a reflective probe cover. © 2011 by General Electric Company. All rights reserved.

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Operating Procedure

5. Position the phototherapy unit over the infant and turn it ON. It is recommended to measure the irradiance level after positioning the device.

NOTE : Factors to consider when using any phototherapy device to ensure proper treatment include: • • • • • •

Maximum body surface area exposed to phototherapy light Distance between the infant from the light source Intensity of light Duration of exposure to phototherapy Total serum bilirubin Skin thickness and pigmentation

3.4 Basic Operating Procedure Below mentioned are the basic operating procedure of the Lullaby LED Phototherapy System.

3.4.1 Adjusting the height of the Lamp enclosure WARNING Adjust the height and distance of the Lamp enclosure before positioning the Lullaby LED Phototherapy System in therapy area. NOTE: Do not adjust the height of the equipment with the patient directly under the unit. 3.4.1.1 Height Adjust Lock The height of the Inner tube can be altered with the Height adjust lock. 1. Hold the Inner tube with one hand. 2. Unscrew the Height adjust lock by turning it anticlockwise. Adjust the inner-tube of the pedestal to increase or decrease the height. 3. Tighten the Height adjust lock by turning it clockwise at the desired height. WARNING 1. Ensure that the Height adjust lock is secured tightly.

Figure 3-1 : Height Adjust Lock

2. Ensure that the distance of the Lamp enclosure is not less than 35 cm from the patient.

3.4.2 Moving the device The swivel casters allows to move the unit with ease in any direction, position the device in the intended location and actuate the brakes. NOTE: Before moving the device ensure that the brakes on all four casters are unlocked. 14

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© 2011 by General Electric Company. All rights reserved.

Operating Procedure

3.4.2.1 Swivel casters with brake 1. Support the light unit with one hand. 2. Apply slight foot pressure on the locking lever to actuate or unlock the casters.

Figure 3-2 : Base with casters

Figure 3-3 : Casters with brakes actuated

3.4.3 Powering-ON the system Connecting the power cord 1. Place the SMPS in the SMPS holder (Figure 3-4). 2. Connect the DC plug of the SMPS cable into the DC jack (Figure 3-5). 3. Fix the power cord to the SMPS (Figure 3-4) and connect the other end of the power cord to the mains supply.

q CAUTION Ensure that the power cord is not in the way of frequent movement to avoid accidental tripping.

Figure 3-4 : SMPS Holder

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Operating Procedure

4. Turn ON the mains and the Power ON/OFF switch on the Lamp enclosure (Refer Figure 3-6). The blue LED lamps will glow (Figure 3-7).

Figure 3-5 : DC Jack

Figure 3-6 : Power ON/OFF switch

Figure 3-7 : LED Phototherapy System with lamps ON

3.4.4 Selecting Irradiance level The intensity of the blue LED lamps can be controlled using the Irradiance selection switch. 3.4.4.1 Irradiance level 1. Select the irradiance level. The symbol II on the switch indicates high intensity and I for low intensity. The nominal output at high intensity is: 45 µW/ cm2/nm ±25% and 22 µW/ cm2/nm ±25% at low intensity setting. NOTE: Monitor the patient during treatment as per hospital guidelines.

Figure 3-8 : Irradiance selection switch

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Operating Procedure

3.5 Tilting the Lamp enclosure The Lamp enclosure can be tilted at an angle up to 900. 3.5.4.1 Tilting the light unit: 1. To tilt the Lamp enclosure loosen the Tilt knob, indicated in the figure, by turning it counter clockwise. 2. Tilt the unit to the desired angle as shown in Figure 3-9. 3. Tighten the Tilt knob by turning it clockwise. WARNING Always support the light unit with one hand when loosening or tightening the tilting knob.

Figure 3-9 : Tilt knob

Figure 3-10 : Tilted at an angle

3.6 Using with other devices The device can be used independently or with other devices such as radiant warmer or incubator. When using it in such situations ensure that the heat source of the devices do not conflict or interfere with the functioning of other equipment.

q CAUTION Follow hospital guidelines and medical protocol when using LED Phototherapy System with other device.

© 2011 by General Electric Company. All rights reserved.

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Operating Procedure

NOTE: The Over heat indicator in the LED Phototherapy System may be activated if the device is not correctly aligned to the heat path of the Warmer. The Figure 3-12 shows the LED Phototherapy System in the path of the Warmer, which is incorrect.

Figure 3-11 : Correct positioning of the LED phototherapy System when used with an Infant Warmer

Figure 3-12 : Incorrect positioning of the LED phototherapy System when used with an Infant Warmer

Figure 3-13 : Using the LED Phototherapy with an Incubator 18

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Operating Procedure

3.7 Using Lamp enclosure in detached condition The Lamp enclosure can be detached from the pedestal and used as a standalone unit. This provides the flexibility to adapt the device to suit any environment. 1. Unplug the power cord from the DC jack. 2. Unscrew both the knobs (Tilt and Securing knob) on the Lamp enclosure (Figure 3-14). 3. Remove the upper arm (Figure 3-15) 4. Hold Lamp enclosure, tilt and lift it off from the Arm (Figure 3-16).

Figure 3-14 : Removing the knobs

5. The Lamp enclosure can now be used safely over an incubator as shown in Figure 3-17. 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. Note: Ensure the SMPS ( power supply ) is properly supported and is not hanging free when used in detach mode. WARNING

Figure 3-15 : Removing the upper arm

1. Do 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. 3. When used on top of an incubator there is a possibility of reduction in the peak irradiance at the incubator bed level. The irradiance will depend on the type of material and design of the incubator canopy.

Figure 3-16 : Detaching the Lamp enclosure

4. 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. 5. Do not detach the unit whilst it is in ON condition. 6. Do not detach the unit whilst it is placed over an infant bed device.

Figure 3-17 : Using on an Incubator

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Operating Procedure

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