13.01.2021»»среда

Biliblanket Light Meter Ii User Manual

13.01.2021

We have biliblankets in our trust, but I thought we did not need to spend a lot of money on the calibrator as we just change the bulbs after so many hours. /volleyball-games-for-ppsspp.html. The trouble was one of my collegues thought that the fibre optic cable was damaged, and we had no way of testing if all the light was.

Which biliblanket do I have and how do I set it up?

Wookie kodi download for windows. Please click “CC” when video begins for captions in Spanish.

Meter
  • Ii 6600-0361-000 08/10/02 ii Next to each warning or caution, we have placed an attention, read accompanying documents symbol to alert you to the presence of these important statements. When the attention symbol appears in front of the text that is printed on the system itself, it means that the text is elaborated upon in the operation manual.
  • Of each region with Ohmeda Biliblanket Light Meter II ™. Bottom light irradiance measured on inside bottom of infant bed, top light irradiance measured on a plane 5cm above. Region sizes determined by phototherapy international standard IEC 60601-2-50. American Academy of Pediatrics 2006 definitions Standard Intensive Average: 23 μW/cm2/nm.
  • You can reading online Biliblanket meter ii manual either download. Therewith, on our website you can read manuals and different art eBooks online, either download their. We will to draw on your regard what our website does not store the eBook itself, but we grant link to the site where you can downloading or read online.
  • You can reading online Biliblanket meter ii manual either download. Therewith, on our website you can read manuals and different art eBooks online, either download their. We will to draw on your regard what our website does not store the eBook itself, but we grant link to the site where you can downloading or read.
  • The flexible fiberoptic light pad is placed in a soft BiliSoft Pad Cover or BiliSoft Nest that is then brought into contact with the patient’s skin. The patient is exposed to light in the wavelength of 430-490 nanometer range (peak 440-460 nanometer). Units are available with two fiberoptic pad sizes: large (25cm x 30cm) and small (15cm x 30cm).

The information on this site is not intended or implied to be a substitute for professional medical advice, diagnosis or treatment. All content, including text, graphics, images and information, contained on or available through this web site is for general information purposes only.

BiliTx Professional Manual

Medical Disclaimer. The information on this site is not intended or implied to be a substitute for professional medical advice, diagnosis or treatment. All content, including text, graphics, images and information, contained on or available through this web site is for general information purposes only.

-

Ohmeda Medical Biliblanket Meter Ii

510(k)DeNovoRegistration & ListingAdverse EventsRecallsPMAHDEClassificationStandards
CFR Title 21Radiation-Emitting ProductsX-Ray AssemblerMedsun ReportsCLIATPLC

Biliblanket Light Meter Ii User Manual

Biliblanket Light Meter


Biliblanket Light Meter Ii Manual

New SearchBack to Search Results
Class 2 Device Recall Giraffe Blue Spot PT LiteTM Phototherapy System
Date Initiated by FirmDecember 11, 2019
Create DateJanuary 31, 2020
Recall Status1Open3, Classified
Z-0923-2020
Recall Event ID84562
K120820
Unit, neonatal phototherapy - Product CodeLBI
ProductGiraffe Blue Spot PT LiteTM Phototherapy System, Model Numbers M1224917, M1231533, M1225025, M1224961, M1224958, M1224957, M1224959, M1224963, M1225773, M1225066, M1224960, M1225059, M1225023, M1225060, M1225063, M1225064, M1225024, M1231622, M1236303, M1238489, M1238490, M1238492, M1238493, M1238495, M1238499, M1238503, M1238505, M1238507, M1238508, 2063860-001, 2063862-001, 2063870-001, 2063873-001, 2063874-001, 2071393-001, 2080916-001, 2089424-001
Code Information2014 Production Serial Numbers: All Serial numbers beginning with QAAT; 2015 Production Serial Numbers: All Serial numbers beginning with QAAU; 2016 Production Serial Numbers: All Serial numbers beginning with QAAV; 2017 Production Serial Numbers: All Serial numbers beginning with QAAW; 2018 Production Serial Numbers: Serial numbers QAAT60001 through QAAT60156
Recalling Firm/
Manufacturer
Lumitex Inc
8300 Dow Cir
Strongsville OH 44136-6600
For Additional Information Contact
440-243-8401
There is a potential for some systems built between 2014 and Jan 2018 to have a light output falling below the recommended minimum output. This problem has been associated with exposure of the light pipe to elevated temperatures, which is contra-indicated in the Operation, Maintenance, and Service Manual.
Device Design
An Urgent Medical Device Correction notification letter was sent to the customer. Actions to be taken by the Customer/User: Please notify all end users, that have received the above listed product that to ensure the patient gets proper levels of treatment they should take the following actions. 1. Immediately check all your device outputs using a BiliBlanket Meter II bilimeter and continue to do so prior to every use, as listed in the Instructions for Use as well as during the treatment session. Instructions as to how to measure your device0019s output are provided in both the Operation, Maintenance, and Service Manual Section 2.1 001cPre-Use Checkout Procedure001d and in the Quick Reference Guide attached to every unit and are detailed below in Appendix 1. Take out of service any units found to have irradiance levels less than 27¿W/cm2/nm and await the free kit to correct the unit that GE Healthcare will be sending for all potentially affected units. Elevated heat can cause the light pipe optical fiber to protrude through its reflector aperture, creating an unfocused spot with less than 27¿W/cm2/nm output as described above. The photos below show the effect and can be used in conjunction with the BiliBlanket Meter II bilimeter to identify units with a low light condition due to elevated heat exposure. 2. As previously stated, exposing the shade head to elevated heat from the warmer is contra-indicated with this device. To prevent potential damage to light pipes due to elevated heat, we remind that care should be taken to position the light pipe, as shown in the Instructions for Use Section 2.2 001cOperation001d and in the Quick Reference Guide, keeping the light pipe Shade head outside the direct path of warmers. Product Correction: To correct any existing devices experiencing low light output due to fiber protrusion and to prevent potential future low light output due to fiber protrusion, GE Healthcare will send a kit to fix all potentially affected units free of c
6837
The products were distributed to the following US states: WI.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LBI and Original Applicant = LUMITEX, INC.