GE Healthcare
Giraffe, Lullaby and Panda Neonatal Systems
Giraffe Shuttle Operation and Maintenance Manual
Operation and Maintenance Manual
68 Pages
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GE Healthcare
Giraffe Shuttle
Operation and Maintenance Manual
To reorder this manual, order kit M1188819. Copyright 2009 by General Electric Company All rights reserved. M1187805 004
© 2009 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® and Panda iRes® are trademarks owned by DatexOhmeda, 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...vii User Responsibility... vii Definition of Terms Used... viii Symbol Definitions... viii
Chapter 1: Product Description... 1 Product Definition...1 Use Environment...1 Product Compatibility...1 Giraffe OmniBed...2 Giraffe Incubator...3 Giraffe and Panda iRes Warmers...4 References... 4
Chapter 2: Safety... 5 Warnings... 5 Cautions... 10 Using the Patient Restraint... 12 Using the Shelf Restraint... 13
Chapter 3: Installation and Setup ... 15 Battery Connection and Charge... 15 Avoiding Physical Interference... 15 Cord and Hose Routing... 16 OmniBed and Incubator O2 Connection... 16 DIN Rail... 17 Center Shelf Installation... 18
Chapter 4: Shuttle Components... 19 Shuttle Component Overview... 19 Shuttle Accessories... 20
© 2009 by General Electric Company. All rights reserved.
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Table of Contents Battery Runtime Indicator... 21 LED Display During Charging... 21 LED Display During Use... 22 Battery Health Indicator... 23 Estimated Battery Life... 24 Typical Use Scenarios and Power Loads... 24
Chapter 5: Transport... 27 Confirming Shuttle Functionality... 27 Preparing for Transport... 28 Recommendations for Thermal Management During Transport... 30 Transporting... 31
Chapter 6: Post-transport... 33 Chapter 7: Maintenance and Cleaning... 35 Battery Replacement... 35 Shuttle Storage... 35 Maintenance Schedule ... 35 Cleaning and Disinfecting... 35 Equipment-safe Cleaning Solutions... 36 Repair Policy... 36
Chapter 8: Troubleshooting... 37 Chapter 9: Accessories... 39 Appendix A: Specifications... 47 Input Power Requirements... 47 Shuttle Output Power... 47 Environmental Requirements... 48 Battery Specifications... 48 Estimated Battery Life... 48 Mechanical Specifications... 49 Service Life... 49 Standards... 49
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© 2009 by General Electric Company. All rights reserved.
Table of Contents
Appendix B: Electromagnetic Compatibility... 51 Electromagnetic compatibility (EMC) guidance... 51 Manufacturer’s guidance and declaration regarding electronic emissions ... 52 Manufacturer’s guidance and declaration regarding electromagnetic immunity... 53 International Electronic Commission (IEC) guidance and manufacturer’s declaration regarding electronic immunity... 54 Recommended separation distance between portable and mobile RF communications equipment and the Shuttle... 55
Appendix C: Warranty... 57
© 2009 by General Electric Company. All rights reserved.
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Table of Contents
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© 2009 by General Electric Company. All rights reserved.
About This Manual
Before using the Giraffe Shuttle (Shuttle), read this entire manual. As with all medical equipment, attempting to use this device without a thorough understanding of its operation may result in patient or user injury. This device should only be operated by personnel trained in its operation and familiar with the risks and benefits of this type of device. Additional precautions specific to certain procedures are found in the text of this manual.
User Responsibility This Product will perform in conformity with the description thereof contained in this Operation and Maintenance 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 GE Healthcare’s prior written approval. The user of this Product shall have the sole responsibility for any malfunction that results from improper use, faulty maintenance, improper repair, damage, or alteration by anyone other than GE Healthcare. CAUTION: U.S. Federal law restricts this device to sale by or on the order of a licensed medical practitioner. For professional use only
© 2009 by General Electric Company. All rights reserved.
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About This Manual
Definition of Terms Used Term Intra-hospital transport
Definition
Bed North end of bed South end of bed Lock
Any microenvironment listed in “Product Compatibility” on page 1.
Unlock
The process of detaching the Shuttle from a bed. Unlocking is accomplished by pressing the Unlock Pedal. Confirmation of successful Shuttle detachment is indicated by the red light next to STOP above the Shuttle pedals.
Patient
An infant receiving care and requiring transport between care areas.
Movement of the Shuttle between defined care areas within a hospital building (examples include but are not limited to: Labor and Delivery, NICU, Radiology, and Operating Room). The Shuttle is not intended for use in and shall not be exposed to the external environment. Use of the Shuttle outside of a hospital building or in uncontrolled climates is considered misuse. The end of the bed where the displays are located. The end of the bed opposite the displays. The process of attaching the Shuttle to a bed. Locking is accomplished by pressing the Lock Pedal. Confirmation of a secure lock is indicated by the green light next to GO above the Shuttle pedals.
Symbol Definitions This section identifies the symbols that are displayed on the Panda iRes and Giraffe Warmers: Symbol
Definition 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 Consult instructions in Operation and Maintenance Manual Protective earth terminal Alternating current
MAX
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Identifies the maximum of the specified value (height, weight, and so on)
M1187805 004
© 2009 by General Electric Company. All rights reserved.
About This Manual Symbol
Definition This red light has two meanings, depending on whether you are attaching or detaching the Shuttle: 1) When you are attaching the Shuttle to a bed, the red light indicates that the Shuttle is properly positioned for locking but is NOT YET LOCKED. You can now proceed to the next step - locking the Shuttle to the bed.
STOP
GO
2) When you are detaching the Shuttle from the bed, the red light indicates that the unlock pedal has been pressed and the Shuttle is UNLOCKED. You can now move the Shuttle away from the bed. Green light - indicates that the Shuttle is LOCKED to the bed, and the bed can be transported.
GO The Lock Pedal is used to lock the Shuttle to a bed
The Unlock Pedal used to unlock the Shuttle from a bed.
Do not step or stand on surface
European Union representative Serial number Manufacturer
For professional use only Equipment shall be used only by qualified, trained medical personnel LATEX FREE
NON STERILE
Latex free Non-sterile
© 2009 by General Electric Company. All rights reserved.
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About This Manual Symbol
Definition Battery Runtime Indicator Battery Health Indicator
Ground Equalization Potential Post
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© 2009 by General Electric Company. All rights reserved.
Chapter 1: Product Description
Product Definition The Giraffe Shuttle is a transportable power source that is an accessory to the Giraffe OmniBed, Incubator, Warmer, and Panda iRes Warmer. The Shuttle connects to the bed and provides electrical power to the bed and other auxiliary equipment, as well as provisions for medical gas management, required for patient care during transport. The Shuttle facilitates the mobility of these beds within the hospital building. This reduces the potential for clinical problems associated with intra-hospital transport that result from interrupted patient thermal regulation. It also eliminates the need to transfer the infant to and from a transport incubator, reducing the potential for clinical problems associated with patient touch, handling, and movement.
Use Environment The Shuttle is used in conjunction with the bed to assist in the transport of patients between care areas within the hospital (intra-hospital) only. These areas include, but are not limited to Labor and Delivery, NICU, Radiology, and Operating Room. The Shuttle is not intended for use outside of the hospital building or in any area where fluctuation in temperature, exposure to water, or other hazards may occur. Use of the Shuttle in uncontrolled climates is considered misuse.
Product Compatibility The Shuttle is compatible only with the following beds:
Giraffe OmniBed
Giraffe Incubator
© 2009 by General Electric Company. All rights reserved.
Giraffe Warmer M1187805 004
Panda iRes Warmer 1
Chapter 1: Product Description
Giraffe OmniBed
The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user’s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermoregulate based on their own physiology. Incubators provide an enclosed, temperature-controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate’s transition from the uterus to the external environment. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide a stable oxygen concentration within the infant compartment at the value set by the operator (2165%). When used with the Shuttle The Giraffe OmniBed can be used with the Giraffe Shuttle, a mobile power source that allows for transport of the patient between care areas within the hospital building and provides power to the OmniBed. These areas include, but are not limited to Labor and Delivery, NICU, Radiology, and Operating Room. The OmniBed with the Shuttle is not intended for use outside of the hospital building.
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© 2009 by General Electric Company. All rights reserved.
Chapter 1: Product Description
Giraffe Incubator
The Giraffe Incubator is an infant incubator, incubators provide heat in a controlled manner to neonates who are unable to thermoregulate based on their own physiology. They achieve this by providing an enclosed temperature controlled environment to the infant. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide a stable oxygen concentration within the infant compartment at the value set by the operator (21-65%). When used with the Shuttle The Giraffe Incubator can be used with the Giraffe Shuttle, a mobile power source that allows for transport of the patient between care areas within the hospital building and provides power to the incubator. These areas include, but are not limited to Labor and Delivery, NICU, Radiology, and Operating Room. The incubator with the Shuttle is not intended for use outside of the hospital building.
© 2009 by General Electric Company. All rights reserved.
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Chapter 1: Product Description
Giraffe and Panda iRes Warmers
Infant radiant warmers provide heat in a controlled manner to neonates who are unable to thermoregulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate’s transition to the external environment or to provide a controlled open environment. An optional integrated SpO2 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). An optional integrated resuscitation system may be used to provide the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant. When used with the Shuttle The Giraffe or Panda iRes Warmer can be used with the Giraffe Shuttle, a mobile power source that allows for transport of the patient between care areas within the hospital building and provides power to the Warmer. These areas include, but are not limited to Labor and Delivery, NICU, Radiology, and Operating Room. The Warmer with the Shuttle is not intended for use outside of the hospital building.
References Refer to Giraffe OmniBed, Incubator, Warmer, or Panda iRes Warmer operation and service manuals for more information about the products that are used with the Shuttle. Refer to the Giraffe Shuttle Service Manual for repair and service information.
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© 2009 by General Electric Company. All rights reserved.
Chapter 2: Safety
Warnings
The following table contains warnings for this manual. A Warning statement is used when the possibility of injury to the patient or the operator exists. Warning
General
Transport
Posttransport
Maintenance and Cleaning
Before using the Shuttle, read this entire manual. As with all medical equipment, attempting to use the Shuttle without a thorough understanding of its operation may result in patient or user injury. The Shuttle should be operated only by personnel trained in its operation and familiar with the risks and benefits of this type of device.
Do not use the Shuttle in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. An explosion hazard exists under these conditions.
Do not leave the patient unattended.
Patient Restraints are intended as single-patientuse only. Discard if soiled.
Complete the instructions in “Confirming Shuttle Functionality” on page 27 before putting the Shuttle into operation. If the Shuttle fails any step, it must be removed from use and repaired.
Before transport, stop using the humidifier and empty the humidifier reservoir. The humidifier reservoir may open during the transport, resulting in spilled water and potential burns from hot water. Monitor patient temperature when humidity is discontinued.
© 2009 by General Electric Company. All rights reserved.
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Chapter 2: Safety
Warning
General
Use the Shuttle only with the power cord supplied.
Before each use, inspect power cords, hoses and gas lines for signs of wear or other damage.
Do not use power outlet strips with the Shuttle.
Note the DIN Rail Load Limit Label and follow guidance. Do not mount more than 25 kg per any Shuttle dovetail rail.
Do not use the Shuttle outside of the hospital building. Do not use the Shuttle for intra-hospital transport through non-environmentally controlled areas where fluctuation in temperature, exposure to water, or other hazards may occur.
Medical Electrical Equipment needs special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in “Appendix B: Electromagnetic Compatibility” starting on page 51.
Do not stand on or place objects onto the lower front cover (arrows). This may cause injury (due to instability) or damage the Shuttle.
Transport
Always perform the instructions in “Confirming Shuttle Functionality” on page 27 prior to connecting the Shuttle to a bed that is occupied by a patient.
The pedals DO NOT assist in stopping the bed during transport. They CANNOT be used as a brake.
Ensure that no power cords, tubes, hoses, gas lines, or any other accessories (including south end DIN rail not compatible with the Shuttle) are mounted between the Shuttle and the bed before connecting the Shuttle to the bed.
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Posttransport
Maintenance and Cleaning
© 2009 by General Electric Company. All rights reserved.
Chapter 2: Safety
Warning
General
Transport
Ensure that all loose hanging power cords, tubes, hoses, gas lines and other lines are safely wrapped before transport.
Ensure that all patient tubings and lines have slack to prevent accidental dislodgement.
Do not mount accessories over the patient compartment.
Ensure that all devices connected to the Shuttle have power fail and/or power fault alarms or independent back-up power.
Unplug the Shuttle from wall outlet before transport.
Observe the patient during transport. If an alarm condition on the bed occurs, stop transport and remedy the primary alarm.
Do not use the Shuttle for emergency evacuation.
Ensure that the Shuttle and the bed are securely locked before transport.
Make sure to disconnect any stationary equipment or equipment not secured to the bed before beginning transport.
Ensure that all accessories are securely mounted and all overhanging arms are folded back to clear doorways and not over the patient compartment. Accessories that do not have a locking mechanism can freely move during transport and may present an impact hazard to the caregiver.
Ensure that there is enough room between the Shuttle and the bed before lowering the bed.
Move all phototherapy and light sources away from patient area during transport.
Hallways, door clearances, elevators, and thresholds may present obstacles during intrahospital transport. Be sure to adjust the height of the bed prior to transport with these conditions in mind.
© 2009 by General Electric Company. All rights reserved.
M1187805 004
Posttransport
Maintenance and Cleaning
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Chapter 2: Safety
Warning
General
Transport
Do not place other medical devices in the patient compartment. Movement of a medical device inside the patient compartment could cause injury to the patient. Interaction of a medical device with an oxygen-concentrated environment could cause fire.
Do not place any equipment on top of the Giraffe OmniBed canopy or Giraffe Incubator hood during transport. Unsecured items placed on the canopy or hood area may fall off or vibrate during transport.
Use Shelf Restraints during transport. Ensure all objects on shelves are secured per Shelf Restraint instructions.
Before transport, ensure that cylinder holders are secured on the rails and that cylinders are mounted evenly and at the right height on both sides (if multiple cylinders are used) before transport.
The Shuttle and the bed are securely locked when the Lock Pedal is in the complete down position and the green light next to GO is illuminated. Moving the Shuttle in any other state could result in partial or complete separation of the Shuttle from the bed.
When transporting, temperature and oxygen levels of the bed may not be maintained. Take appropriate precautions when transporting.
The Shuttle and connected bed are intended for single patient transport only.
Never move the bed with the Shuttle connected when the red light next to STOP is on.
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Posttransport
Maintenance and Cleaning
© 2009 by General Electric Company. All rights reserved.
Chapter 2: Safety
Warning
General
Transport
Posttransport
The combined weight of the Shuttle and bed may exceed 295 kg. Safely transporting the bed requires close attention. To avoid patient or caregiver injury, it is essential that at least two people be involved in the transport process. If an incline or decline will be encountered during transport, it is highly recommended that additional staff be ready to assist.
Do not use humidifier reservoir as a handle during transport.
Do not travel on inclines greater than 5 degrees. Interference between the Shuttle, the bed, and ancillary equipment may be experienced when traveling up inclines greater than 5 degrees.
Always lock both Shuttle wheels for safe and effective parking.
Never attempt to unlock the Shuttle on inclined pathways unless the wheel locks on the bed are activated.
The use of open bed warmers during transport may result in patient cooling or overheating. Follow hospital policies and procedures for transportation in warmers.
Never leave a bed unattended when transporting a patient.
Use Patient Restraint during transport to secure the patient to the mattress and bed. Ensure that it does not interfere with patient-connected devices.
When moving patient between care areas, physiological monitoring (including temperature measurement) should be continuously employed.
Do not use the Shelf Restraint to secure the patient.
Always ensure sufficient slack of the Silo support to prevent unintended tension to abdominal wall.
© 2009 by General Electric Company. All rights reserved.
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Maintenance and Cleaning
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Chapter 2: Safety
Warning
General
Transport
Posttransport
Ensure that all appropriate power cords, tubes, hoses, gas lines, and other lines are disconnected from the Shuttle before disconnecting the Shuttle from the bed.
To prevent inadvertent motion of the bed and ensure patient safety, wheel locks on the end of the bed must be set before disconnecting the Shuttle.
Maintenance and Cleaning
The Shuttle must be serviced only by authorized service personnel.
Do not service the Shuttle while it is in clinical use.
Always wear gloves when disinfecting the Shuttle.
Do not disinfect the Shuttle when the possibility of direct patient contact with disinfecting agents exists.
Cautions
The following table contains cautions for this manual. A Caution statement is used when the possibility of damage to the equipment exists. Caution
General Do not block the cooling fan vent (arrow).
The Shuttle will not protect the bed during low line voltage (brownouts).
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Posttransport
Maintenance and Cleaning
The Shuttle will not support low line voltage (brownouts).
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Transport
© 2009 by General Electric Company. All rights reserved.