NeoLight Skylife Service Manual
Infant phototherapy system
Hide thumbs
Also See for Skylife:
- User manual (19 pages) ,
- Quick reference manual (2 pages) ,
- Quick reference manual (2 pages)
Related Manuals for NeoLight Skylife
Summary of Contents for NeoLight Skylife
- Page 1 Skylife™ Infant Phototherapy System Service Manual Service Manual English 500050 Rev A © 2021 by NeoLight LLC. All rights reserved. © 2022 by NeoLight LLC. Page 1 of 43 All rights reserved. 500050 Rev A...
- Page 2 Skylife is a registered trademark of NeoLight LLC © 2021 by NeoLight LLC. All rights reserved. This manual may not be reprinted or copied in whole or in part without written consent from NeoLight LLC. The content of this manual may change without notice.
-
Page 3: Table Of Contents
Chapter 3: Components and Controls ........................12 3.1 System Components: ............................13 Chapter 4: Routine Maintenance Procedures ......................18 4.1 Assembling and Disassembling Skylife ......................18 4.2 Cleaning and Disinfection Procedure (for both professional and home use): ......... 20 4.3 Performance Verification ........................... 22 4.4 Replacing the GelMat............................ - Page 4 This page is left intentionally blank. © 2022 by NeoLight LLC. Page 4 of 43 All rights reserved. 500050 Rev A...
-
Page 5: User Responsibility
The components of the Skylife System must be replaced as directed for the proper function of the system. Please complete service checks listed in Appendix A every half a year (6 months) to ensure all components of the Skylife device are correctly functioning, and replacements are made accordingly. -
Page 6: Chapter 1: About This Manual
Skylife is intended for the treatment of neonatal unconjugated hyperbilirubinemia. It is designed to provide phototherapy treatment from underneath the baby. Skylife must be used within a patient enclosure, such as a bassinet, an open crib, a warming table, or an incubator. Skylife can be used in a clinical setting or in the home. -
Page 7: Chapter 2: Safety Information
Minimum and maximum operating and storage temperature range Minimum and maximum storage humidity range Minimum and maximum operating atmospheric pressure range. Type B.F. Applied parts © 2022 by NeoLight LLC. Page 7 of 43 All rights reserved. 500050 Rev A... - Page 8 Background information provided to clarify a particular step or procedure. NOTE Information in this category is not considered precautionary © 2022 by NeoLight LLC. Page 8 of 43 All rights reserved. 500050 Rev A...
-
Page 9: Warnings
WARNING: Use the Skylife Phototherapy System only for its intended use as described in this manual WARNING: Never operate the system if it has a damaged plug, damaged or frayed power cord, or wires. - Page 10 Monitor the baby's bilirubin levels during phototherapy according to your practitioner's recommendations. WARNING: The Skylife device should be turned off before evaluating the baby's skin color, as lighting will affect visual color evaluation. Parents should contact their medical practitioner if needed.
- Page 11 CAUTION: Do not drop the device. If the system is dropped, contact your hospital technician or the manufacturer for further information before using the Skylife unit. CAUTION: Ensure that the device is inaccessible to children or pets when not in use.
- Page 12 This page is left blank intentionally. © 2022 by NeoLight LLC. Page 12 of 43 All rights reserved. 500050 Rev A...
-
Page 13: Chapter 3: Components And Controls
The Controller allows the operator to turn the device on/off and set the treatment dosage. 4. AC/DC Adapter This module converts A.C. power to DC power © 2022 by NeoLight LLC. Page 13 of 43 All rights reserved. 500050 Rev A... - Page 14 8. Vent Holes a. Provide ventilation for the thermal management of the Light Modules b. Feet to elevate the Light Bed © 2022 by NeoLight LLC. Page 14 of 43 All rights reserved. 500050 Rev A...
- Page 15 Surface Area. It's located beneath the GelMat. 11. Skylife Disposable A disposable product that fits the Light Bed isolates it from the Swaddle: CloudCover neonate. © 2022 by NeoLight LLC. Page 15 of 43 All rights reserved. 500050 Rev A...
- Page 16 A disposable product that fits on the Light Bed firmly holds the neonate. Note: Velcro is highlighted in Blue only visualization purposes. The fully engaged CloudCover Plus is shown below. © 2022 by NeoLight LLC. Page 16 of 43 All rights reserved. 500050 Rev A...
- Page 17 13. Skylife Carrying Case High-density plastic case with foam inserts to carry Skylife conveniently for administering Home Phototherapy 14. Skylife Travel Case High-density plastic case with foam inserts, rollers, and telescopic handles to carry Skylife safely and conveniently for administering Home Phototherapy.
-
Page 18: Chapter 4: Routine Maintenance Procedures
Chapter 4: Routine Maintenance Procedures This chapter includes procedures for routine maintenance of the Skylife system. These procedures may be performed after any of the following events and/or as prescribed by the institution's maintenance schedule: • Initial receipt of the Skylife at the institution. - Page 19 Sleeve IMPORTANT! Disconnect the Controller from the Light Bed only when the device has to be packaged for shipment. © 2022 by NeoLight LLC. Page 19 of 43 All rights reserved. 500050 Rev A...
-
Page 20: Cleaning And Disinfection Procedure (For Both Professional And Home Use)
Ensure that the disposables do not cover the vents 4. Connect the power cord to the electrical outlet 5. Using the Controller, ensure that Skylife can be turned on/off, the light intensity can be increased/decreased, and the treatment can be paused/un-paused. - Page 21 GelMat may require cleaning. Do not remove the GelMat during cleaning. CAUTION: Do not immerse the Skylife or its accessories in liquid or clean with caustic or abrasive cleaners. Likewise, do not spray or pour any liquid on the Skylife enclosure.
-
Page 22: Performance Verification
Skylife Disposable Swaddle. Please ensure Skylife is operating at optimum levels using the following procedure: 1. Skylife's performance is evaluated by measuring its light intensity across twenty-six 1x1" cells at each treatment setting (Low, High, and Very High) ©... - Page 23 2. Apply a disposable swaddle over the Skylife Light Bed as described in section 4.1. Using a pencil, draw a twenty-six cell grid as shown. Each cell is 1" x 1". Ensure that the 7 cell in both rows is located at the center as shown.
-
Page 24: Replacing The Gelmat
8. Spectral measurements are prone to variation in measurement techniques. If the device fails to meet the requirements a 2 time, contact NeoLight customer support. 4.4 Replacing the GelMat CAUTION: Do not clean the Light Bed top surface with any liquids. Instead, use dry cloth wipes only on the cloudy area of the Light Bed. - Page 25 6. Ensure that the GelMat's Q.R. code label does not overlap any of the existing warning labels on the Light Bed. © 2022 by NeoLight LLC. Page 25 of 43 All rights reserved. 500050 Rev A...
-
Page 26: Replacing Light Modules
2. 40 in-oz Torque Driver with Torx 10 Tip 3. Tweezers 4. Spare screws - 18-8 Stainless Steel Low-Profile Socket Head Screw with Hex Drive, 6-32 Thread Size, 3/8" Long © 2022 by NeoLight LLC. Page 26 of 43 All rights reserved. 500050 Rev A... - Page 27 CAUTION: Only use the NeoLight issued light module replacements for the device as any other part may result in the device being ineffective or dangerous to the user. CAUTION: Ensure that the device is turned off and unplugged before proceeding.
-
Page 28: Logging The Light Module Use-Life
It is advised to document the Light Module Hours in the provided Service Guide whenever a maintenance check occurs. To check the hours: 1. Ensure that the Skylife system has been powered on as per operating instructions. 2. Once the device is on, begin a standard treatment by pressing the "+" button. Then pause the treatment by pressing the power button once to prevent eye strain from blue light. - Page 29 If any errors arise during this process, proceed to **(Troubleshooting Section) * for further instructions. 4.7 Packaging Instructions for Skylife Carrying and Travel Cases NOTE This procedure applies to both the Skylife Carrying Case (SKY-CAS) and Skylife travel Case (SKY-TRV) 1. Open out the case on a sufficiently large work surface.
-
Page 30: Homecare Providers
4.8 Homecare Providers Ensure when you deliver Skylife for use in the home that you provide adequate in-service training for parents or guardians. Be sure to provide all the Instructions for Use, Quick Reference Guides, Skylife Disposable Swaddles, and eye covers. -
Page 31: Chapter 5: Troubleshooting
Pressing any key will mute the Warning for 180 seconds " REPLACE!" module is exceeded the Turn-off device recommended limit of Contact NeoLight to order replacement light modules 25,000 hours Follow the "Replacing Light Modules" procedure in Chapter 4.5 to replace the old light modules. - Warning Message:... - Page 32 "!! SYSTEM FAILURE Line Failure Data Port 2. 00004" Data Port 2 is designed with a jumper wire between pin 6 and 7 on the cable connector © 2022 by NeoLight LLC. Page 32 of 43 All rights reserved. 500050 Rev A...
- Page 33 00004 and SYSTEM FAILURE 00008 00024" Error - Warning Message: Bank 1 EEPROM error Restart the system "!! SYSTEM FAILURE If the error persists, contact NeoLight 00032" © 2022 by NeoLight LLC. Page 33 of 43 All rights reserved. 500050 Rev A...
- Page 34 Likely Cause Trouble Shooting Steps Functionality Issues - Warning Message: Bank 2 EEPROM error Restart the system "!! SYSTEM FAILURE If the error persists, contact NeoLight 00064" - Warning Message: Loose Controller J1 Contact NeoLight "!! SYSTEM FAILURE Connector 00120"...
- Page 35 Damaged Parts Cables or Connectors, Incorrect method Remove the unit from service and contact NeoLight or or excessive force trained service personnel. used on All damaged parts must be replaced and the unit checked to attachment and ensure no internal damage has occurred.
-
Page 36: Chapter 6: Accessories And Replacement Parts
Chapter 6: Accessories and Replacement Parts Please contact NeoLight customer Service for any replacements and parts needed. The following parts are critical components to the efficacy and safety of our products and must be replaced as directed. Part Name Catalog Number... -
Page 37: Chapter 7: Product Specification
15% and 90% R.H. Stabilization Time The Skylife Phototherapy System does not require a pre-aging time. It is ready for use immediately after turning on the initial time. The Skylife Phototherapy System does not require a stabilization period. It is... -
Page 38: Chapter 8: Technical Reference
>0.4 (avg. 0.79). Note: The CloudCover Light Intensity distribution on Lightbed (with GelMat and attenuates an average of 0.4 CloudCover). μW/cm²/nm. Spectral Properties of Light © 2022 by NeoLight LLC. Page 38 of 43 All rights reserved. 500050 Rev A... -
Page 39: Chapter 9: Compliance Declaration
Portable R.F. communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Skylife device, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. - Page 40 Electromagnetic Emissions Skylife™ is intended for use in the electromagnetic environment specified below. Therefore, the customer or the user of Skylife™ should ensure that it is used in such an environment. Emission Tests Compliance Electromagnetic Environment – Guidance Skylife™ uses R.F. energy only for its internal function.
-
Page 41: Chapter 10: Warranty
Product, excluding the Disposable Parts (collectively with the Light Modules, the "Covered Components"). The GelMat, the Skylife Disposable Swaddles, or other expendable or disposable parts of the Product are the "Disposable Parts." NeoLight will replace your Skylife device free of charge, provided the system: •... -
Page 42: Appendix A: Service Guide - System Evaluation
All the measured, averaged, and adjusted light intensities per section 4.3 pass the acceptance criteria Service Performed/Notes: © 2022 by NeoLight LLC. Page 42 of 43 All rights reserved. 500050 Rev A... -
Page 43: Appendix B: Service Guide - Gelmat And Light Module Use-Life Log
IMPORTANT! The routine maintenance must be performed at the time of replacing the GelMat every 6 months, 1,500 hours of use, or if damaged, whichever comes first © 2022 by NeoLight LLC. Page 43 of 43 All rights reserved. 500050 Rev A...