GE BiliSoft, Operation And Maintenance Manual

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9-2 M1110147 Rev. 5 © 2007 Datex-Ohmeda. All rights reserved.
Performance Specifications
Spectral Irradiance (bare fiberoptic pad)*
*Using an Ohmeda Medical BiliBlanket
Meter II Large Fiberoptic Pad – 49 µW • cm
-2
• nm
-1
(+/-
25%) 9-point check
Small Fiberoptic Pad – 70 µW • cm
-2
• nm
-1
(+/-
25%) 6-point check
Note: When the BiliSoft fiberoptic light pad is
inserted into a BiliSoft Pad Cover or BiliSoft
Nest, the nominal spectral irradiance is 35
µW•cm
-2
•nm
-1
(large pad) and 50 µW•cm
-
2
•nm
-1
(small pad)
Wavelength 430-490 nm (peak 440-460 nm)
LED module estimated life
*
Under continuous use, tested at room
temperature, a typical LED module will run for
approximately 8,000 to 10,000 hours before
the light intensity drops 25%.
Sound level < 44 dB(A) at 1 meter
X-ray X-ray compatible
Physical Specifications
Light box (W x H x L) 16.5 x 21 x 16.5 cm
Light box weight (excluding fiberoptic pad) < 2.5 kg
Fiberoptic Pad weight < 1.1 kg
Fiberoptic light pad, small 15 x 30 cm (light-emitting area)
Fiberoptic light pad, large 25 x 30 cm (light-emitting area)
Fiberoptic cable length 137 ± 5 cm
Regulatory Standards
IEC Type B equipment.
IEC Class 1 (continuous operation)
FDA Class II Product certified to the following
standards:
EN60601-1; EN60601-1-2; EN60601-2-50; ISO
10993-5; ISO 10993-10; UL 60601-1; CSA
C22.2 No 601.1-M90; IEC 60601-1-8; BS EN
980; 16CFR Part 1632.6 (for BiliSoft Pad
Covers and BiliSoft Nests)
*
The LED module life may vary when used in the actual clinical environment. Factors such as duty cycle and
ambient temperature may impact the life of the LED module. Measure the irradiance of the BiliSoft System and
replace the LED module when the system is below specifications.