GE BiliSoft LED Phototherapy System Operation and Maintenance Addendum Rev B April 2017

English

Additional Safety Information

Statements This device should only be operated by personnel trained in its operation and familiar with the risks and benefits of this type of device. Warning: To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Warning: The user or service staff should dispose all the waste properly as per federal, state, and local waste disposal regulations. Improper disposal could result in personal injury and environmental impact. Warning: Prolonged exposure to any phototherapy light may cause eye damage. Infants should wear eye protection during therapy. Care should also be taken to protect the eyes of infants adjacent to the treatment area Warning: Exposure to any phototherapy device for prolonged periods may cause side effects in some caregivers and visitors. Warning: The bilirubin levels of infants receiving phototherapy should be regularly measured. Warning: All phototherapy methods have possible risks including, but not limited to apnea, bronze baby syndrome, cellular DNA disruption, diarrhea, hyperpigmentation-reddening, patent ductus arteriosus, riboflavin-calcium and other deficiencies, skin blistering, skin irritation and thrombocytopenia. Monitor the baby closely for signs of these conditions during phototherapy. Warning: Bilirubin photoisomers may cause toxic effects.

Warning: Porphyrins are the by-products of the photochemical break down of the bilirubin molecule. In some cases, exposure of porphyrins to phototherapy may result in a localized reddening of the infant’s skin. Therefore, skin assessment is indicated with all types of phototherapy. Warning: Light can adversely affect drugs and other infusion liquids. When using intravenous delivery systems during phototherapy, shield any tubing with an appropriate material. Do not store drugs or infusion liquids directly in the light path.

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English Additional Safety Information Warning: Phototherapy light can affect the temperature in thermoregulation devices (incubator, radiant warmers or heated mattresses) and may raise the patient’s body temperature. Always monitor the infant’s temperature to avoid temperature fluctuations during phototherapy. Warning: The radiant energy from phototherapy lights can increase an infant’s insensible water loss. Take appropriate measures to maintain the patient’s fluid balance while administering phototherapy. Warning: It is recommended to use the incubator or warmer in skin controlled (servo) mode. Always monitor the infant’s temperature to avoid temperature fluctuations during phototherapy. Warning: Never use flammable solutions to clean the BiliBlanket Plus Phototherapy System or any of its parts. Warning: Using reflective foils to increase the efficacy of phototherapy may cause hazardous patient body temperatures. Warning: Do not use the phototherapy system in the presence of flammable anesthetics or gases which can support combustion; a possible explosion hazard exists under these conditions.. No additional tasks are required to power down the device after clinical use, other than turning off the unit. Isolation of the unit from the supply mains can be achieved by turning off the device with the power switch. Warning: Electrical shock hazard: Before servicing, always unplug the unit from wall power. Phototherapy light can hinder clinical observations by masking skin color changes, such as cyanosis. This device shall be used only by appropriately trained personnel and under the direction of qualified medical personnel familiar with currently known risks and benefits of infant phototherapy equipment use.

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English Additional Safety Information

Symbols This section identifies the symbols that are displayed on the device: Symbol

Description Consult Manual Do Not Place Objects Under Radiant Heat Cover Patient Eyes

Checkout Procedures Examine the unit for any missing or damaged labels.

Specifications The product is designed to meet a life span of 7 years. However, with proper maintenance and repairs, the service life can be extended as long as service parts are available. Noise level <60dB(A) (measured 90 cm from the unit)

The following information is provided for compliance to IEC 60601-2-50:

BiliBlanket Spectral Intensity Distribution

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English Additional Safety Information

Total Spectral Irradiance (measure with a spectroradiometer between 400550nm) is 6.86 milliwatts per square cm.

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