Neo Blue Blanket Manual

broken image


Manual
Neo blue blanket manual pdf
  • Compatible with PowerSeries Neo, PowerSeries Pro and Qolsys panels. PG9905-PG8905-PG4905 Installation Manual ENG FRE SPA POR - 29008705R001.
  • NeoBLUE blanket, large pad kit 006245 neoBLUE blanket, small pad kit 006898 Mattress, large (Qty 2) 007281 Mattress, small (Qty 2) 007283 Disposable covers, large (Qty 50) 005989 Disposable covers, small (Qty 50) 006897 neoBLUE blanket Swaddle.- Newborn (fits large pad) 008424 neoBLUE blanket Swaddle.- Preemie (fits small pad) 008425.
  • 6182-1GE Neo-Drone Wifi App - Download. 6182-1GE Neo-Drone Wifi Instruction Manual - Download. 6182-1GHB VideoDrone GPS Instruction Manual - Download. 6182-1GXA Air Hover Racer Instruction Manual - Download. 6182-1GXA Air Hover Racer Lap Counter Instructions - Download. 6182-2BD Explorer GPS - Download. 6182-2BEA Rover GX - Download.

The BiliLux is a compact and lightweight LED phototherapy light system for the treatment of neonatal jaundice. It provides superior phototherapy performance, individualised therapy with electronic documentation capabilities and the flexibility for seamless integration into practically every workplace. Canopus advc 55 driver windows 7. Page 6 Ambient Operating Temperature DC Voltage Authorized European Representative Manufacture Date XXXX Manufacturer Natus WEEE Directive (Waste from Electrical and Electronic Equipment Directive) Symbol – Product should not be disposed of in normal waste Hot Surface neoBLUE® cozy Service Manual P/N 051915 Rev.

-
510(k)|DeNovo|Registration & Listing|Adverse Events|Recalls|PMA|HDE|Classification|Standards
CFR Title 21|Radiation-Emitting Products|X-Ray Assembler|Medsun Reports|CLIA|TPLC

Neo Blue Blanket Manual Parts


Neo Blue Blanket Manual Transmission

New SearchBack to Search Results
Class 2 Device Recall Natus neoBLUE blanket LED Phototherapy system
Date Initiated by FirmMarch 16, 2015
Date PostedApril 10, 2015
Recall Status1Terminated 3 on December 20, 2016
Z-1412-2015
Recall Event ID70810
K103589
Unit, neonatal phototherapy - Product CodeLBI
ProductNatus neoBLUE blanket LED Phototherapy system which includes the following items:
006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad
006254 neoBLUE blanket LED Light Box
006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad
007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR
007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR
007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK
007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK
007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS
007302 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS
Code InformationNone
Recalling Firm/
Manufacturer
Natus Medical Incorporated
5900 1st Ave S
Seattle WA 98108-3248
For Additional Information ContactTechnical Service
888-496-2887
neoBLUE blanket LED Phototherapy System is recalled because Natus has received feedback from some customers about early failure of the neoBLUE blanket system fiberoptic pads. These failures involve discoloration and melting of the fiberoptic bundle at the connector that is inserted in the neoBLUE blanket light box.
Other
Natus sent the PRODUCT RELIABILITY ALERT neoBLUE blanket system performance along with an attached Technical Bulletin, Instructions for Use, and Service Manual to consignees via email during the week of March 16, 2015. Natus emailed the Distribution Partner (DP) letter to all Natus International Distribution Partners, requiring that they notify their customers (at Biomedical Department and Neonatal Intensive Care Unit) with copies of the Field Safety Notice, customer letter, the Technical Bulletin, Instructions for Use, and Service Manual. The technical bulletin asks the customer to visually and tactilely inspect the fiber optic cable connector before use, and to call Natus if they notice a failing pad. This procedure will prevent the complete degradation and therapy will not be compromised. U.S. customers should contact Natus Technical Service at 888-496-2887 with any questions regarding this notification. International customers should contact their local distributors or contact Natus Technical Service at (888) 496-2887 or Technical_Service@natus.com.
2611 units (1911 units in the US and 700 units outside the US)
distributed worldwide
TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LBI and Original Applicant = NATUS MEDICAL INCORPORATED




broken image