Addendum
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For future reference, add to your Giraffe® OmniBed or Giraffe Incubator, Giraffe Warmer, Panda® iRes Warmer operation and maintenance manual.
Addendum Product Definition The Shuttle is a transportable power source that is an accessory to the Giraffe OmniBed, Incubator, Warmer, and Panda iRes Warmer. The Shuttle facilitates the mobility of these beds within the hospital building. 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.
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 When a bed is used with the Shuttle, the intended use of the bed is different from when the bed is used as a stationary device. The Shuttle is compatible only with the following beds:
Giraffe OmniBed
Giraffe Incubator
© 2010 by General Electric Company. All rights reserved.
Giraffe Warmer
Panda iRes Warmer
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Addendum
Giraffe OmniBed The following table describes the intended use for Giraffe OmniBed: Intended use without the Shuttle
When used with the Shuttle
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 (21-65%). 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.
Giraffe Incubator The following table describes the intended use for Giraffe Incubator: Intended use without the Shuttle
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.
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© 2010 by General Electric Company. All rights reserved.
Addendum
Giraffe and Panda Warmers The following table describes the intended use for Giraffe and Panda Warmers: Intended use without the Shuttle
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 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.
© 2010 by General Electric Company. All rights reserved.
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World Headquarters
EC Representative
GE Healthcare 9900 West Innovation Drive Wauwatosa, WI 53226-4856 USA Tel 1 800 345 2700
Datex-Ohmeda Ltd. Ohmeda House 71 Great North Road Hatfield Hertfordshire AL9 5EN Tel +44 1707 263570 Fax +44 1707 260065
Europe, Middle East, Africa
Germany
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Latin America Representatives
Asia Representative
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GE Healthcare Shanghai GE (China) Hi-tech Park No1 Huatuo Road, Zhangjiang Hi-tech Park Pudong, Shanghai, P.R.China 201203 上海 GE 中国科技园 地址:中国上海市浦东张江高科技园华佗路 1 号 , 201203 Tel + (8621) 38777888 Fax + (8621) 38777402
Brazil Only
GE Healthcare Clinical Systems Equipamentos Médicos Australia: Ltda Av. Paulista, 37 - 13º andar China: CEP: 01311-902 - Cerqueira César India: São Paulo, SP - Brasil Korea: Tel +55 11 3053 2500 South Eastern Asia: Fax +55 11 3053 2573
Ohmeda Medical, a Division of Datex-Ohmeda, Inc., a General Electric Company 8880 Gorman Road Laurel MD 20723 USA
1300 722 229 800 810 8188 1 800 425 7255 (02) 1544 4564 (65) 6277 3444
Giraffe OmniBed, Incubator, Warmer, and Panda iRes Warmer Addendum Intended Use with and without Shuttle Printed in USA Copyright 2010 by General Electric Company All rights reserved.
M1205712 001 Language: English Printing instructions: Black on white 8.5” x 11” paper size Two (2) sides print Three (3) hole punch Stapled or shrink wrapped