Giraffe Blue Spot PT Lite Operation Maintenance and Service Manual Rev C

© 2012 by 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. Giraffe® is a registered 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. Warranty This product is sold by GE Healthcare with a period of 12-month of GE depot repair warranty that covers labor and parts (except for the LED Module assembly which has a 24-month warranty and the expendable parts like fan which have a 30-day warranty) under the terms and conditions set forth in the GE Healthcare Warranty Statement presented to the customer at the point of sale. The product warranty is only offered through GE service depot. Field service is not covered under warranty for this product.

Table of Contents

About this Manual...5 Scope and Intended Users...5 Conventions...5 User Responsibility...6

Part I: Operation and Maintenance... 7 Important Operation Safety Information...9 Contraindications... 11 Symbol Definitions... 11 Chapter 1: Product Overview... 13 1.1 Intended Use... 13 1.2 Product Description... 13 1.3 Controls, Indicators, and Connections... 14 Chapter 2: Product Setup and Operation... 17 2.1 Pre-use Checkout Procedure... 17 2.2 Operation... 19 Chapter 3: Operator’s Maintenance... 23 3.1 Cleaning and Maintenance... 23 3.2 Options... 25 Chapter 4: Operator Troubleshooting... 27 Chapter 5: Specifications... 29 5.1 Electrical Specifications... 29 5.2 Environmental Specifications... 29 5.3 Performance Specifications... 30 5.4 Standards... 31

Part II: Service... 33 Important Service Safety Information... 35 Chapter 6: System Description... 45 Chapter 7: Installation... 47 7.1 Time Required for Installation... 47

3

Table of Contents 7.2 Environmental Requirements... 47 7.3 Tool Requirements... 47 7.4 Installation Procedure... 48 Chapter 8: Service Maintenance and Checkout... 51 8.1 Procedures Schedule... 51 8.2 Environmental Requirements... 51 8.3 Tool Requirements... 52 8.4 Maintenance and Checkout Procedures... 52 Chapter 9: Calibration... 55 Chapter 10: Diagnostics and Troubleshooting... 57 10.1 Troubleshooting Fuses... 61 10.2 Test Points and Adjustment Point Locations... 62 Chapter 11: Replacement Procedures... 63 11.1 Air Filter Replacement... 64 11.2 Fuse Replacement... 64 11.3 Light Pipe / O-ring / Ground Clip Replacement... 65 11.4 Light Shade Replacement... 66 11.5 Unit Cover / Control Board Replacement... 67 11.6 Power Inlet Module / AC and DC Harness Replacement... 68 11.7 LED Module, LED Driver Board, Fan Replacement... 69 11.8 Power Supply Replacement ... 71 Chapter 12: Service Parts... 73 12.1 Illustrated Parts... 74 12.2 Labels... 84 12.3 Power Cords... 85 12.4 FRU List... 85 12.5 Wiring Diagram... 88 Chapter 13: Electromagnetic Compatibility... 89

4

About this Manual

Scope and Intended Users This operation, maintenance, and service manual describes how to use, maintain, and service the Giraffe Blue Spot PT Lite Phototherapy System. This manual has two parts, one for Operation and Maintenance and one for Service. The intended users for the Operation and Maintenance part of this manual are end users of the equipment, primarily care providers in the hospital setting. The intended users for the Service part of this manual are hospital biomedical engineering services and GE Service personnel. This device should only be operated by personnel trained in its operation and familiar with the risks and benefits of this type of device.

Conventions Various types of pictures or icons are used in this manual wherever they reinforce the printed message to alert you to potential safety hazards in one of the following ways: WARNING: A WARNING statement is used when the possibility of injury to the patient or the operator exists. CAUTION: A CAUTION statement is used when the possibility of damage to the equipment exists. SENSITIVE TO ELECTROSTATIC DISCHARGE CAUTION An Electrostatic Discharge (ESD) Susceptibility symbol is displayed to alert service personnel that the part(s) are sensitive to electrostatic discharge and that static control procedures must be used to prevent damage to the equipment.

5

About this Manual

User Responsibility This Product will perform in conformity with the description thereof contained in this operating manual and accompanying labels and/or inserts, when assembled, operated, maintained and repaired in accordance with the instructions provided. This Product must be checked periodically. A defective Product should not be used. Parts that are broken, missing, plainly worn, distorted or contaminated should be replaced immediately. Should such repair or replacement become necessary, GE Healthcare recommends that a telephone or written request for service advice be made to the nearest GE Healthcare Regional Service Center. This Product or any of its parts should not be repaired other than in accordance with written instructions provided by GE Healthcare and by GE Healthcare trained personnel. The Product must not be altered without the prior written approval of GE Healthcare’s Quality Assurance Department. The user of this Product shall have the sole responsibility for any malfunction which results from improper use, faulty maintenance, improper repair, damage, or alteration by anyone other than GE Healthcare. WARNING: No modification of this device is allowed. CAUTION: U.S Federal law restricts this device to sale by or on the order of a licensed medical practitioner.

6

Part I: Operation and Maintenance

7

Part I: Operation and Maintenance

This page is intentionally left blank.

8

Important Operation Safety Information

WARNING: Do not use the Giraffe Blue Spot PT Lite in the presence of flammable anesthetics (e.g. ether) mixture with air or with oxygen or nitrous oxide which can support combustion; a possible explosion hazard exists under these conditions. WARNING: Blue light can hinder clinical observations by masking skin color changes, such as cyanosis. WARNING: Do not block the power cord plug. It may be needed for emergency power shutoff. WARNING: Prolonged exposure to any phototherapy light may cause eye damage. Prolonged stay in the area irradiated by the phototherapy equipment may cause some effects on the operator. Never look directly at the light. Infants should wear eye protection during therapy. Take care to protect the eyes of infants adjacent to the treatment area. WARNING: Regularly measure the bilirubin levels of infants receiving phototherapy according to hospital policy and procedure. WARNING: All phototherapy methods have possible risks including, but not limited to bronze baby syndrome, diarrhea (loose green stool), hyperpigmentation-reddening, skin blistering (oxidative tissue damage), skin irritation(rashes), water loss, and dehydration. Monitor the baby closely for signs of these conditions during phototherapy. WARNING: Bilirubin photoisomers may cause toxic effects. WARNING: Porphyrins are by-products of the photochemical break down of the bilirubin molecule. In some cases, exposure of porphyrins to phototherapy may result in localized reddening of the infant’s skin. Therefore, skin assessment is indicated with all types of phototherapy. WARNING: Take appropriate measures to maintain the patient’s fluid balance while administering phototherapy. WARNING: To avoid patient injury, do not mount the system while a patient occupies the bed. WARNING: To avoid the risk of electrical shock, the system must only be connected to a supply mains with protective earth.

9

Important Operation Safety Information WARNING: Light can adversely affect drugs and other infusion liquids. When using intravenous delivery systems during phototherapy, shield any tubing with appropriate material. Do not store drugs or infusion liquids directly in the light path. WARNING: When using the device with a radiant warmer, make sure the light shade is not directly in the path of the radiant heat rays. If the light shade is in the path, it will block heat to the patient and may damage the light shade. WARNING: It is recommended to set the incubator or warmer in baby controlled (servo) mode when these devices are used with phototherapy light. Always monitor the infant’s temperature and make the appropriate adjustments to avoid temperature fluctuations during phototherapy. WARNING: Phototherapy light can affect the temperature in the thermoregulation devices (incubators, radiant warmers or heated mattresses) and may raise the patient’s body temperature. Always monitor the infant’s temperature and make the appropriate adjustments to these devices to avoid temperature fluctuations during phototherapy. WARNING: Using reflective foils to increase the efficacy of phototherapy may cause hazardous patient body temperatures. WARNING: Oxygen enriched environments greatly reduce the temperature at which materials burn. Be extremely careful to remove all opaque materials from the immediate light path when using the light while administering oxygen. WARNING: If the system is mounted on a portable roll stand, lock the wheels to prevent movement of the device during the therapy. WARNING: The power cord presents a trip hazard. Do not leave the cord unattended when located in traffic areas. WARNING: Periodically check that the patient is in the treatment area of the device. WARNING: Follow hospital policy and procedure for bilirubin, temperature, skin and eye assessments during use of phototherapy. WARNING: Never use flammable cleaning solutions to clean the Giraffe Blue Spot PT Lite.

10

Important Operation Safety Information CAUTION: Service this product in accordance with the service manual only with the proper tools, test equipment and the most recent revision of the service manual, which is clearly and thoroughly understood. CAUTION: To avoid the device overheating, do not block any of the vents on the light box. CAUTION: Do not place opaque objects in the direct light path. Light energy can cause heating and damage to nontransparent materials. CAUTION: Only use GE Healthcare approved spare parts.

Contraindications Contraindications to phototherapy*: • • •

Congenital porphyria or family history of porphyria Concomitant use of drugs or agents that are photosensitive Concurrent therapy with metalloporphyrin heme oxygenase inhibitors

Phototherapy effectiveness may be decreased in presence of cholestasis (direct hyperbilirubinemia). * MacDonald & Ramasethu (2007). Atlas of Procedures in Neonatology, Lippincott Williams & Wilkins, Philadelphia, PA

Symbol Definitions This section identifies the symbols that are displayed on the Giraffe Blue Spot PT Lite Phototherapy System:

Symbol

Description Consult accompanying documents. Do not place the Giraffe Blue Spot PT Lite in the path of radiant heat from another device. High voltage, electrical shock hazard

~

Indicates alternating current European Union Representative Hour meter display Standby/on switch Cover infant’s eyes during phototherapy. Over-temperature / under-temperature condition

11

Important Operation Safety Information Symbol

Description Potential equalization stud

Recommended distance from the light shade to the patient

This symbol indicates that the waste of electrical and electronic equipment must not be disposed as an unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment.

12

Chapter 1: Product Overview

Chapter 1: Product Overview

1.1 Intended Use The GE Healthcare Giraffe® Blue Spot PT LiteTM Phototherapy System provides light therapy for the treatment of hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in the hospital. This therapy is to be administered by trained, professional medical staff, on the order of a licensed medical practitioner.

1.2 Product Description An LED provides the therapeutic light source. A fan cools the LED and extends LED life. As soon as the device is connected to a power outlet, it is ready for use. A standby/on switch on the front of the device turns the therapeutic light on and off. Located near the switch, a non-resettable hour meter display shows how long the device has been emitting therapeutic light during the life of the product. Below the hour meter display, a green indicator lights when the device is on standby, a blue indicator lights when the device is emitting therapeutic light, and a red indicator will flash if the fan fails to operate correctly or the device overheats. The red indicator will illuminate continuously, while the fan operates, if the device is too cold. The fan will operate in an attempt to cool, or warm, the system into the proper operating temperature. Underneath, on the base of the device are the IEC power inlet, two fuses, potential equalization stud, and the fan filter retainer. A mounting bracket on the back of the device allows the device to be positioned and secured in the dovetail slot of an accessory rail. It can be mounted on any GE Healthcare system with dovetail rails. Tightening two socket head mounting screws holds the device in position. The light intensity delivered to the patient varies directly with the distance of the light shade from the mattress. The intensity and spot size can be changed by manually adjusting this distance. The flexible light pipe bends to a new position and then holds the light shade in place. The flexible light pipe transmits the light from the LED to the light shade, where it can be directed at the patient.

13

Chapter 1: Product Overview

1.3 Controls, Indicators, and Connections

2

1

13 3

14 4 5 6 7 12

8

11 FRONT

BACK

10

9

BOTTOM

Figure 1-1

1. Light shade

8. Light box

2. Light pipe

9. Power cord inlet*

3. Hour meter display

10. Fuses Compartment

4. Exhaust vents

11. Intake vents/air filter

5. Over/under temperature indicator

12. Potential equalization stud

6. Standby/on indicator

13. Light pipe port

7. Standby/on switch*

14. Light shade protective cover

* To isolate the device from the supply mains: • For a wall-connected device, unplug the power cord. • For a device connected to a microenvironment’s accessory outlet, switch off the mains switch on the back of the microenvironment.

14

Chapter 1: Product Overview The following table describes the meaning of each status for each indicator: Table 1-1: Indicators

Indicator Standby/on indicator

Hour meter display

Over/under temperature indicator

Status

What it Normally Means

Off

The device has no power.

Green

The device is in standby and not emitting light.

Blue

The device is emitting light.

Off

The device has no power.

Displaying numbers

The device is in standby or emitting light. The number represents the number of hours the device has been emitting light during the the life of the device.

Off

No temperature problems detected.

Steady red

Under-temperature condition

Flashing red*

Over-temperature condition

*The over/under temperature red indicator briefly flashes every time the Standby/On switch is depressed to turn on the therapeutic light in order to confirm the function of the alarm indicator.

For operator troubleshooting instructions, refer to Chapter 4.

15

Chapter 1: Product Overview

This page is intentionally left blank.

16

Chapter 2: Product Setup and Operation

Upon shipment, the light pipe is detached from the light box. Prior to first use, the light pipe needs to be attached and secured to the light box and then the device needs to be mounted on the dovetail rail of a microenvironment or a portable roll stand. Installing the device shall be performed by authorized service personnel only. For instructions, refer to section 7.4. WARNING: To avoid patient injury, do not mount the system while a patient occupies the bed. WARNING: To avoid the risk of electrical shock, the system must only be connected to a supply mains with protective earth, using the power cord supplied.

2.1 Pre-use Checkout Procedure Follow below checkout instructions prior to first system use and then before any time the system is put into operation: 1. Examine the device for missing parts or obvious signs of damage, including power cord, light pipe, light box, and labels. If damage is found, do not use the device and contact service personnel. 2. Check that the light box is securely attached to the accessory dovetail rail or roll stand, i.e. the device does not slide up or down the dovetail rail. 3. Move the light pipe to verify that it moves freely and stays in position. NOTE: The light pipe will typically experience some minor deflection (less than 1.3cm) after positioning. 4. Connect the power cord to an appropriate power source. The standby/on indicator will light green to indicate standby mode. 5. Press the standby/on switch to turn on the therapeutic light. The standby/on indicator will change from green to blue and the over-temperature/under-temperature indicator will briefly illuminate. 6. Confirm that the fan is operating by momentarily placing your hand close to the exhaust vent when the device is on to feel the air flow coming out of the device. 7. Focus the therapeutic light such that the spot diameter is 35.5 cm (14 in) or the shade is 38 cm (15 in) from the bed surface. 17

Chapter 2: Product Setup and Operation 8. Allow the Giraffe Blue Spot Pt Lite to warm-up 5 minutes. 9. Using a calibrated Biliblanket Light Meter II, measure the light at the 5 points indicated in Figure 2-1 and calculate their average. Confirm that the average is at least 27 μW · cm-2 · nm-1. If not, refer to symptom OS4 on Chapter 4.

2

5

3.5”

1

3.5” 4

3

3.5”

3.5”

Figure 2-1 Light Measurement Points 10. Divide the lowest reading by the highest reading. If the LED light is functioning properly, the result should be greater than 0.4. If the result is not greater than 0.4, contact service. NOTE: IEC standards recommend LED module replacement at 25% output reduction, which corresponds to 27 μW · cm-2 · nm-1 and occurs at approximately 10000 hours. However, sufficient irradiance for effective phototherapy continues well after 25% reduction

18

Chapter 2: Product Setup and Operation

2.2 Operation WARNING: Prolonged exposure to any phototherapy light may cause eye damage. Prolonged stay in the area irradiated by the phototherapy equipment may cause some effects on the operator. Never look directly at the light. Infants should wear eye protection during therapy. Take care to protect the eyes of infants adjacent to the treatment area. WARNING: Light can adversely affect drugs and other infusion liquids. When using intravenous delivery systems during phototherapy, shield any tubing with appropriate material. Do not store drugs or infusion liquids directly in the light path. WARNING: It is recommended to set the incubator or warmer in baby controlled (servo) mode when these devices are used with phototherapy light. Always monitor the infant’s temperature and make the appropriate adjustments to avoid temperature fluctuations during phototherapy. WARNING: Phototherapy light can affect the temperature in the thermoregulation devices (incubators, radiant warmers or heated mattresses) and may raise the patient’s body temperature. Always monitor the infant’s temperature and make the appropriate adjustments to these devices to avoid temperature fluctuations during phototherapy. WARNING: Using reflective foils to increase the efficacy of phototherapy may cause hazardous patient body temperatures. WARNING: Oxygen enriched environments greatly reduce the temperature at which materials burn. Be extremely careful to remove all opaque materials from the immediate light path when using the light while administering oxygen. WARNING: Follow hospital policy and procedure for bilirubin, temperature, skin and eye assessments during use of phototherapy. CAUTION: To avoid the device overheating, do not block any of the vents on the light box. CAUTION: Do not place opaque objects in the direct light path. Light energy can cause heating and damage to nontransparent materials.

19

Chapter 2: Product Setup and Operation WARNING: When using the device with a radiant warmer, make sure the light shade is not directly in the path of the radiant heat rays. If the light shade is in the path, it will block heat to the infant and may damage the light shade.

1. Place the infant in the center of the bed mattress. 2. Cover the infant’s eyes with eye protection. Clinicians should refer to the instructions for use provided with the specific eye protection being used for proper application and use. 3. Maximize the infant’s skin exposure to the therapeutic light. For example, use the smallest size diapers and avoid blanket rolls or positioning aids that block the light source. 4. If the system is mounted on a portable roll stand, lock the wheels to prevent the movement of the device during the therapy. 5. Press the standby/on switch to turn on the therapeutic light. 6. Position the light shade at 38cm from the infant and aim the light towards the infant. The spot diameter will be 35.5cm. 7. Using a calibrated Biliblanket Light Meter II, measure irradiance at the umbilicus when the infant is supine and the lumbar area when the infant is prone. 8. The light shade may be raised to adjust light output and desired surface coverage. 9. Monitor the infant’s temperature during phototherapy treatment. 10. Monitor patient’s fluid intake and output during phototherapy treatment.

20