NeoLight SKYLIFE User Manual
Phototherapy system
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Also See for SKYLIFE:
- Quick reference manual (2 pages) ,
- Quick reference manual (2 pages) ,
- Service manual (43 pages)
Related Manuals for NeoLight SKYLIFE
Summary of Contents for NeoLight SKYLIFE
- Page 1 SKYLIFE PHOTOTHERAPY SYSTEM USER MANUAL Website: www.theneolight.com Address:275 N Gateway Drive, Suite #128 Phoenix, AZ 85034 Contact: support@theneolight.com or (480) 626-0304...
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Page 2: Table Of Contents
CONTENTS INTRODUCTION INTENDED USE SKYLIFE SYSTEM COMPONENTS EXPLANATION OF SYMBOLS 4.1 Warnings & Precautions SKYLIFE OPERATING INSTRUCTIONS 5.1 Setting up the system 5.2 Preparing the baby for phototherapy 5.3 Administering phototherapy 5.4 Routine maintenance CUSTOMER SERVICE AND MAINTENANCE 6.1 Customer service 6.2 Repair &... -
Page 3: Introduction
The terms “neonatal” and “neonate” refer to a baby from birth through the first 28 days of life. The Skylife device is intended for use with all neonatal subpopulations. -
Page 4: Intended Use
The Skylife system is intended for the treatment of neonatal unconjugated hyperbilirubinemia. It is designed to provide phototherapy treatment from underneath the baby. The Skylife unit must be used within a patient bed, such as a bassinet, an open crib, a warming table or an incubator. The system can be used in a clinical setting or in the home. -
Page 5: Explanation Of Symbols
4. EXPLANATION OF SYMBOLS The following symbols are used in this user manual, on the device packaging, on the device and accessory labeling. Symbol Description Symbol Description Type BF applied parts Reference number; part number Lot number Caution Protected electrical shock from touch Serial number by hands greater than 12 millimeters. -
Page 6: Warnings & Precautions
11. Keep the Skylife controller and cords in a location away from toddlers, children and pets. 12. The Skylife Light Bed and GelMat must be used only with the Cloud Swaddle / Cloud Swaddle Plus provided. Any other type of cover may cause a reduction in light intensity. -
Page 7: Skylife Operating Instructions
(Steps 1 - 6 are applicable in both home and hospital settings.) 5.1 SETTING UP THE SYSTEM Place the Skylife device in a location with walls (e.g. bassinet, warmer, crib, or incubator). Caution: Do not allow items such as blankets to cover the outside edges of the device. - Page 8 (Steps 5 - 6 are applicable in a hospital setting only, including technical references on this page.) Light Sensor Prior to placing the baby on the device, turn on the device to the desired treatment level(s). To check the light intensity, follow institutional practices. Recommended Spectrophotometer Specifications Ohmeda Medical Recommended Model...
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Page 9: Preparing The Baby For Phototherapy
PREPARING BABY FOR PHOTOTHERAPY Before starting treatment, always shield the baby’s eyes with a protective eye mask designed for use during phototherapy. During phototherapy treatment, regularly remove the coverings according to hospital policy to assess the baby’s eyes for signs of irritation or infection. Important! Eye Protection: Do not look directly into the blue light for a prolonged period of time. -
Page 10: Administering Phototherapy
Once baby is secure, turn on the device and use the controller to administer therapy. Follow the steps below and set light intensity level as directed by physician to achieve desired results*. Normal use cycle: NEOLIGHT SKYLIFE PHOTOTHERAPY LED LIFETIME SELF TEST PASSED VERSION 1.0... - Page 11 Resume treatment. If high temperature condition persists, power OFF the device and remove the baby from the Skylife device. Contact treating physician, technician, or manufacturer. System Failure Condition: If any part of the device fails to perform as expected, a “System Failure’ alarm will sound, LED indicators on controller will flash and the device will shut OFF automatically.
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Page 12: Routine Maintenance
For healthcare and home use, make sure to use the disposable Cloud Swaddle according to the directions above. The Skylife device is to be cleaned using standard cleaning cloths (such as Super Sani Cloth®) prior to use. You may clean the non-body contact areas such as the Light Bed, GelMat, controller, and power supply of the Skylife™... -
Page 13: Customer Service And Maintenance
Please contact NeoLight Customer Service in case of any damage or failure of the Skylife system. • Do not attempt to repair any part of your Skylife unit(s). Never dismantle the system due to risk of electric shock. NeoLight LLC declines all responsibilities for any damages or consequences resulting from unauthorized attempts to open, modify, or repair the device. -
Page 14: Calibration
Skylife device labels have been designed to ISO 15223-1. 6.5 OPERATING CONDITIONS The Skylife system should be operated in temperatures between 50°F and 98.6°F (10°C and 37°C), atmospheric pressures between 50 and 106 kPa (7.25psi to 15.37psi), and relative humidity between 15% and 90% RH. -
Page 15: Transportation And Storage Conditions
Follow instructions supplied with parts to replace them. 6.9 WARRANTY NeoLight offers a warranty of 1 year for the Skylife system. In addition, Neolight warrants the light modules for 25,000 hours*. Should your Skylife unit develop a fault within the warranty period, NeoLight will replace your Skylife device free of charge, provided the system: •... -
Page 16: Technical Specifications
7. TECHNICAL SPECIFICATIONS* 7.1 ELECTRICAL AC Power 90-264 VAC, 50-60 Hz, 1.0A/115V- 0.5A/230V Type of Protection Against Electrical Shock Class II Equipment Degree of Protection Against Electrical Shock Type BF Applied Part Degree of Protection Against Ingress of Water IP23 Mode of Operation Continuous 7.2 LIGHT DISTRIBUTION... -
Page 17: Compliance Declaration
Medical device software — Software life cycle processes 7.5 STABILIZATION TIME The Skylife Phototherapy System does not require a pre-aging time. It is ready for use immediately after it is turned on the initial time. The Skylife Phototherapy System does not require a stabilization period. It is ready for use immediately after it is powered ON. -
Page 18: Guidance & Manufacturer's Declaration
Complies emissions IEC 61000-3-3 Electromagnetic Immunity Skylife™ is intended for use in the electromagnetic environment specified below. The customer or the user of Skylife™ should assure that it is used in such an environment. Immunity Test Compliance Level Electromagnetic Environment –... - Page 19 SKYLIFE PHOTOTHERAPY SYSTEM Skylife is a trademark of Neolight LLC U.S.A. This Skylife Phototherapy System is protected by US Patent ID: 15/143,277 and 15/882,485.