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500050 Rev A

Appendix A: Service Guide - System Evaluation

Lot/Serial #

Date

Controller Evaluation:

Controller Serial #

Step

Criteria

Pass

Fail

The Controller performs as per instructions in the User Manual

Light Module Use is <24,900 hrs.

Record Light Module
Hours:

LM1: _________(hrs.) LM2: __________(hrs.)

Light Bed Evaluation:

Light Bed Serial #

Step

Criteria

Pass

Fail

GelMat is clear and not yellow/discolored

GelMat is adhered to the Light Bed and not damaged (tears or holes)

GelMat is no older than 6 months, has not undergone more than 1,500
treatment hours, or does not affect calibrated light intensity levels.

All the measured, averaged, and adjusted light intensities per section 4.3
pass the acceptance criteria

Service Performed/Notes:

Summary of Contents for SKYLIFE

Page 1: ... 2022 by NeoLight LLC All rights reserved Page 1 of 43 500050 Rev A Skylife Infant Phototherapy System Service Manual Service Manual English 500050 Rev A 2021 by NeoLight LLC All rights reserved ...

Page 2: ...itioner 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 NeoLight LLC 1475 N Scottsdale Rd Suite 110 Scottsdale AZ 85257 Customer Support 1 866 934 8945x 1 Technical Support 1 866 934 8945x 2 ...

Page 3: ... 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 24 4 5 Replacing Light Modules 26 4 6 Logging the Light Module Use life 28 4 7 Homecare Providers 30 Chapter 5 Troubleshooting 31 Chapter 6 Accessories and Replacement Parts 36 Chapter 7 Product Specification 37 Chapt...

Page 5: ...en approval NeoLight LLC is not responsible for any damages or consequences resulting from unauthorized attempts to open modify or repair the device This unauthorized service of the Product also voids the warranty 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 tha...

Page 6: ... blue light emitting diodes LEDs to provide treatment for neonatal unconjugated hyperbilirubinemia Skylife is designed to provide phototherapy treatment from underneath the baby The system must be used within a patient enclosure such as a bassinet an open crib a warming table or an incubator Skylife utilizes blue LEDs to achieve intensities from 25 μW cm2 nm to 55 μW cm2 nm emitting light in a nar...

Page 7: ...Part Number Catalog Identification Lot Number Serial Number Manufacturing Date Legal Manufacturer Name Follow Instructions for Use Prescription only USA The product contains electrical equipment Therefore users should not discard this product along with other household waste Minimum and maximum operating and storage temperature range Minimum and maximum storage humidity range Minimum and maximum o...

Page 8: ...t s eyes during phototherapy Single use only Do not reuse Hazard of severe electric shock or burn Non Sterile Class II Equipment WARNING A WARNING statement is used when the possibility of injury exists CAUTION A CAUTION statement is used when the possibility of damage to the equipment exists IMPORTANT Instruction provided to help ensure correct clinical results and provide quality assurance to th...

Page 9: ...essible to the baby WARNING Keep the Skylife controller and cords in a location away from toddlers children or pets WARNING The Skylife Light Bed and GelMat must be used only with the Skylife Disposable Swaddles Any other type of cover may cause a reduction in light intensity WARNING Baby eye protection is required before turning on the Skylife unit WARNING If the user should experience discomfort...

Page 10: ...incubators warmers bassinets or crib as it could result in improper operation CAUTION Do not disassemble the Skylife device unless you are a certified technician following NeoLight service instructions CAUTION Do not use items such as blankets to cover the device CAUTION Do not place the device where it can fall or be pulled into a tub sink or other liquid sources CAUTION Do not operate the Skylif...

Page 11: ...turer for further information before using the Skylife unit CAUTION Ensure that the device is inaccessible to children or pets when not in use CAUTION Handle GelMat with care Do not stretch twist or fold the GelMat CAUTION Keep sharp objects away from 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 CAUT...

Page 13: ...t b GelMat Placement Indicator Stickers c Handles for Light Bed 2 GelMat This is a soft transparent gel mattress attached to the top plastic enclosure of the Light Bed The mattress helps distribute pressure underneath the body prominences of the baby to offer comfort 3 Controller The Controller allows the operator to turn the device on off and set the treatment dosage 4 AC DC Adapter This module c...

Page 14: ...tat Port c Light Module Printed Circuit Board PCB d LEDs 6 Power Cord This cord plugs into the electrical outlet 7 Power and Data Cable This cable connects the Controller and the Light Bed It carries power and data signals to operate the device 8 Vent Holes a Provide ventilation for the thermal management of the Light Modules b Feet to elevate the Light Bed a b a b c d d d d d d d d ...

Page 15: ... b Increase Light Intensity g Treatment setting Indicator c Decrease Light Intensity h LCD Display d Access to System Settings i Removable Controller connector e Power Indicator light 10 Diffuser Channels the LED light to create a uniform Treatment Effective Surface Area It s located beneath the GelMat 11 Skylife Disposable Swaddle CloudCover A disposable product that fits the Light Bed isolates i...

Page 16: ...43 500050 Rev A 12 Skylife Disposable Swaddle CloudCover Plus 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 1 2 3 5 ...

Page 17: ...ic 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 The case also comes with a TSA approved padlock ...

Page 18: ...tenance should be performed according to each section s requirements Cleaning and disinfection should occur between patients or if the Skylife Disposable Swaddles are soiled or damaged 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 NOTE Please record the Light Module hours of use in our S...

Page 19: ...eatment 3 Connect the Controller and Light bed Power and Data Cable a Light Bed Cable b Ensure the Arrow is facing up when connecting IMPORTANT When disconnecting pull the sleeve to properly disconnect the cable from the port to avoid damaging the connection lock a Sleeve IMPORTANT Disconnect the Controller from the Light Bed only when the device has to be packaged for shipment b a a ...

Page 20: ...that the Controller beeps for each button press Contact NeoLight if the Controller does not provide this audible feedback 4 2 Cleaning and Disinfection Procedure for both professional and home use It is recommended to use Super Sani Cloth however similar quaternary ammonium disinfectants can be used provided they have similar Isopropyl Alcohol concentration around 55 Quaternary ammonium compounds ...

Page 21: ...e Skylife mattress cover instead of Skylife Disposable Swaddles refer to its reprocessing instructions 2 Using recommended pre moistened disinfection wipes such as Super Sani Cloth remove all visible contamination from the GelMat and verify under standard lighting 3 After all visible contamination has been removed use disinfection wipes to thoroughly wet the exposed surfaces of the GelMat and edge...

Page 22: ...s neoBLUE Radiometer μW cm2 nm Respironics Joey Dosimeter μW cm2 nm 20 0 18 1 52 7 25 0 22 4 65 8 30 0 26 8 78 9 35 0 31 2 92 0 40 0 35 5 105 1 45 0 39 9 118 2 50 0 44 2 131 3 55 0 48 6 144 4 60 0 52 9 157 5 65 0 57 3 170 6 70 0 61 7 183 7 75 0 66 0 196 9 80 0 70 4 210 0 IGE Conversion Formula INN 0 8713 IGE 0 6617 Conversion Formula IRJ 2 6214 IGE 0 2450 IMPORTANT Skylife is factory calibrated wi...

Page 23: ...y press on the swaddle surface until you feel the swaddle fabric s tension Then measure the light intensity at this cell Repeat the same to collect irradiance measurements from all 26 points on the grid NOTE If your facility uses light meters others than GE Ohmeda Biliblanket Mater ii refer to the table above for conversion or contact customer support 4 Determine the average of the measurements fr...

Page 24: ... 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 Tools and Materials Required 1 70 Iso Propyl Alcohol 2 Microfiber cloth NOTE GelMat should only be replaced by a Biomed technician or other medical professional Please document this replacement in the Service Guide provided in Appendices A B 1 R...

Page 25: ... is recommended to hold the shorter edges with your fingers and place the GelMat down with its center hanging creating a U shape Once the position is finalized gently place the GelMat onto the Light Bed 5 Ensure the position of the GelMat is in the center of the Light Bed using the blue lines as indicators 6 Ensure that the GelMat s Q R code label does not overlap any of the existing warning label...

Page 26: ...remove any bubbles continue with the same motion on the other side and then move until all edges have adhered 9 Firmly press the GelMat onto the Light Bed to finish 10 Perform a final check by running a finger against the edge of the GelMat to ensure it has securely adhered 4 5 Replacing Light Modules Tools and Materials Required 1 Nose pliers 2 40 in oz Torque Driver with Torx 10 Tip 3 Tweezers 4...

Page 27: ...ews next to the straight rubber feet holding the light modules Do not unscrew the screws shown with the red x marks NOTE If only one Light Module needs to be replaced they can be differentiated before removing the screws Light Module 1 a can be accessed with the screws closest to the power and data cable Therefore Light Module 2 b is housed farther from the cable 2 Carefully remove the old Light M...

Page 28: ...weezers flathead screwdriver or very carefully with the tips of your fingers Make sure to not press on the wires down during this process 5 Gently place the Light module back into the Light Bed Tighten the screws to 40 in oz by using a calibrated torque screwdriver IMPORTANT Do not over torque the light module screws as they may damage the device 4 6 Logging the Light Module Use life It is advised...

Page 29: ...ided Appendices A B for this purpose Ensure to start a new sheet after replacing Light Modules NOTE 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 sufficie...

Page 30: ...own below Note that the Controller and Lightbed are still connected Then start tucking the cable connecting the Lightbed and Controller into the slot as shown You will have to hold the Lightbed very close to the case while performing this step 6 Gently place the Skylife unit on the foam as shown close the lid and secure with latches lock 4 8 Homecare Providers Ensure when you deliver Skylife for u...

Page 31: ...4 Clear the area around the device and restart the device after 10 mins 5 If the issue persists contact NeoLight Warning Message HIGH TEMP ALARM TURN DEVICE OFF Repetitively beep the buzzer and flash the alarm indicator LEDs The treatment indicator LEDs shall turn off The LED banks have exceeded threshold temperature for Alarms 1 Turn off the device 2 Check if vents are blocked 3 Clear the area ar...

Page 32: ...rt 1 is designed with a jumper wire between pin 8 and 7 on the cable connector 3 Inspect the connector for sufficient contact 4 If the connector is not seated correctly reconnect the bank properly per the provided instructions in Chapter 4 5 and restart the device 5 If wiring damage is seen or if the error persists after correction contact NeoLight Warning Message SYSTEM FAILURE 00004 LED Bank 2 C...

Page 33: ...s If the thermostat module was not disconnected try disconnecting the module using either tweezers or a small flat head screwdriver Then reconnect and restart the system 3 If the wires are damaged or if the issue persists after reconnection contact NeoLight Warning Message SYSTEM FAILURE 00016 Bank 2 temperature sensor error 1 Refer to the instructions provided for SYSTEM FAILURE 00008 but access ...

Page 34: ...g Message SYSTEM FAILURE 00120 Loose Controller J1 Connector 1 Contact NeoLight Warning Message SYSTEM FAILURE 00128 Stalled Fan 1 Restart the system 2 If the error persists contact NeoLight Warning Message SYSTEM FAILURE 00256 Temperature sensor error 1 Turn off the device 2 Check if vents are blocked 3 Clear the area around the device and restart the device after 10 mins 4 If the issue persists ...

Page 35: ...Enclosure or Diffuser damaged is cracked 1 The unit was dropped or sustained damage through impact with another object 1 Remove the unit from service and contact NeoLight or trained service personnel 2 All damaged parts must be replaced and the unit checked to ensure no internal damage has occurred Out of Specification Light Output measurement is out of specification 1 Improper measurement setup 2...

Page 36: ...librated levels whichever occurs first CloudCover CC 1 single unit CC 5 5 pack 24 hours of use if soiled or between each patient CloudCover Plus CCP 1 single unit CCP 5 5 pack 24 hours of use if soiled or between each patient Newborn Eye Protection NL EP 01 NEWBORN1 Per patient or if soiled Preemie Eye Protection NL EP 01 PREMIE Per patient or if soiled Micro Eye Protection NL EP 01 MICRO Per pati...

Page 37: ... cm Length of connecting cord between controller and power adapter 53 134 62 cm Length of the power cord from the adapter to plug 66 5 168 91 cm Transportation and Storage The Skylife device should be transported and stored in temperatures between 13 F and 122 F 25 C and 50 C atmospheric pressures between 50 and 106 kPa 7 25 psi to 15 37 psi and relative humidity between 10 and 93 R H Operating Co...

Page 38: ...ace Area is 119 in2 represented by the blue grid Maximum intensity in the center The minimum to maximum measured intensity ratio across the effective surface area is 0 4 avg 0 79 Note The CloudCover attenuates an average of 0 4 μW cm nm Light Intensity distribution on Lightbed with GelMat and CloudCover Spectral Properties of Light ...

Page 39: ...d guidance for alarm systems in medical electrical equipment and medical electrical systems IEC 62304 2006 Medical device software Software life cycle processes Electromagnetic Compatibility EMC The Skylife system is suitable for the electromagnetic environment of typical homes commercial or hospital settings During the immunity testing described below the Skylife device delivered treatment at a 4...

Page 40: ...cial or hospital environment Surge IEC 61000 4 5 1 kV differential mode The mains power quality should be that of a typical home commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 0 5 Periods 0 1 Period 70 25 Periods 0 5 sec The mains power quality should be that of a typical home commercial or hospital environment ...

Page 41: ...nual Has regular periodic maintenance and service and disposable parts are replaced and repairs are made according to the service or user manual Has not been connected to an unsuitable power source Has not been subjected to misuse Has not been modified or repaired by any unauthorized party without prior consent from NeoLight Actual results may vary Such warranties are extended only with respect to...

Page 42: ...d Light Module Hours LM1 _________ hrs LM2 __________ hrs Light Bed Evaluation Light Bed Serial Step Criteria Pass Fail 1 GelMat is clear and not yellow discolored 2 GelMat is adhered to the Light Bed and not damaged tears or holes 3 GelMat is no older than 6 months has not undergone more than 1 500 treatment hours or does not affect calibrated light intensity levels 4 All the measured averaged an...

Page 43: ...cement Expected GelMat Replacement Schedule Light Module use life in Hours Date Light Module 1 Life hours Light Module 2 Life hours 1 1 500 2 3 000 3 4 500 4 6 000 5 7 500 6 9 000 7 10 500 8 12 000 9 13 500 10 15 000 11 16 500 12 18 000 13 19 500 14 21 000 15 22 500 16 24 000 17 25 000 IMPORTANT The routine maintenance must be performed at the time of replacing the GelMat every 6 months 1 500 hour...

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