GE Giraffe Blue Spot PT Lite Manual

Girae® Blue Spot PT Lite™
Operation, Maintenance, and Service Manual
GE Healthcare

© 2012 by General Electric Company
All rights reserved. General Electric Company reserves the right to make changes in specications 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. Girae® 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 oered through GE service depot. Field service is not covered under warranty
for this product.

3
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 Denitions .................................................................................................................................................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: Specications ............................................................................................................................................... 29
5.1 Electrical Specications...................................................................................................... 29
5.2 Environmental Specications ............................................................................................ 29
5.3 Performance Specications ............................................................................................... 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

4
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

5
About this Manual
Scope and Intended Users
This operation, maintenance, and service manual describes how to use, maintain, and service the Girae
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
benets 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.

6
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 modication 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.

7
Part I: Operation and Maintenance

8
Part I: Operation and Maintenance
This page is intentionally left blank.

9
Important Operation Safety Information
WARNING:
Do not use the Girae Blue Spot PT Lite in the presence of ammable 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 shuto.
WARNING:
Prolonged exposure to any phototherapy light may cause eye damage. Prolonged stay in the area
irradiated by the phototherapy equipment may cause some eects 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 eects.
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 uid 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.

10
Important Operation Safety Information
WARNING:
Light can adversely aect 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 uctuations during phototherapy.
WARNING:
Phototherapy light can aect 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
uctuations during phototherapy.
WARNING:
Using reective foils to increase the ecacy 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 trac
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 ammable cleaning solutions to clean the Girae Blue Spot PT Lite.

11
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 eectiveness may be decreased in presence of cholestasis (direct hyperbilirubinemia).
* MacDonald & Ramasethu (2007). Atlas of Procedures in Neonatology, Lippincott Williams & Wilkins, Philadelphia, PA
Symbol Denitions
This section identies the symbols that are displayed on the Girae Blue Spot PT Lite Phototherapy System:
Symbol Description
Consult accompanying documents.
Do not place the Girae 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

12
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.

Chapter 1: Product Overview
1.1 Intended Use
The GE Healthcare Girae® 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 sta, 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
o.
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 ash 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 lter 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 exible
light pipe bends to a new position and then holds the light shade in place. The exible 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
Figure 1-1
1. Light shade
2. Light pipe
3. Hour meter display
4. Exhaust vents
5. Over/under temperature indicator
6. Standby/on indicator
7. Standby/on switch*
8. Light box
9. Power cord inlet*
10. Fuses Compartment
11. Intake vents/air lter
12. Potential equalization stud
13. Light pipe port
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 o the mains switch on the back of the
microenvironment.
1
2
3
4
5
6
7
FRONT BACK BOTTOM
8
13
14
12
11 9
10
14
Chapter 1: Product Overview

The following table describes the meaning of each status for each indicator:
Table 1-1: Indicators
Indicator Status What it Normally Means
Standby/on indicator
O The device has no power.
Green The device is in standby and not emitting light.
Blue The device is emitting light.
Hour meter display
O 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.
Over/under temperature indicator
O No temperature problems detected.
Steady red Under-temperature condition
Flashing red* Over-temperature condition
*The over/under temperature red indicator briey ashes every time the Standby/On switch is depressed to turn
on the therapeutic light in order to conrm 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 1: Product Overview

Chapter 2: Product Setup and Operation
Upon shipment, the light pipe is detached from the light box. Prior to rst 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 rst 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 deection (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 briey illuminate.
6. Conrm that the fan is operating by momentarily placing your hand close to the exhaust vent when
the device is on to feel the air ow 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

8. Allow the Girae 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. Conrm that the average is at least 27 μW · cm-2 · nm-1. If not, refer to
symptom OS4 on Chapter 4.
1
3
2
4
5
3.5”
3.5”
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, sucient irradiance for
eective 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 eects 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 aect 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 uctuations during phototherapy.
WARNING:
Phototherapy light can aect 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 uctuations during phototherapy.
WARNING:
Using reective foils to increase the ecacy 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 specic 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 uid intake and output during phototherapy treatment.
20
Chapter 2: Product Setup and Operation