LIT-246 CUDA
®
Surgical
Rev. E (English)
Page 5 of 80
2.3. Notes
•
Battery packs supplied from the manufacturer and approved vendors are
distributed in a discharged state. Please fully charge the battery packs before
using the headlight for the first time.
•
The headlight produces some heat in addition to light, which causes the module and/or
holster to become warm. This is normal operation.
•
This device may interfere with other electrical equipment if used outside a hospital
setting.
•
The LED headlight is not provided sterile, nor is sterilizable.
3. SPECIFICATIONS
PARAMETER
VALUE
Light Output
70,000 lux (0-100% infinitely adjustable)
40cm / 16 inch working distance
Runtime
3hr at full intensity (6hr at 50% intensity) with standard battery
6hr at full intensity (12hr at 50% intensity) with extended life
battery pack
Color Temperature
4500K typ.
CRI
75 typ.
Spot Diameter
20-110mm (infinitely adjustable)
Operating Conditions
32 to 86⁰F (0 to 30⁰C)
30 to 75% RH, non-condensing
4. CERTIFICATIONS
PARAMETER
VALUE
System Classification
FDA Class I, Device Listing 125713
EU Class I, Active device per Annex IX, rule 1
EMC Certifications
CISPR 11 Class A
CE Marking
CE Marking for MDD 93/42/EEC and AMD 2007/47/CE
Degree of protection against
harmful ingress of water
IPX-0; no protection.
Degree of safety in the
presence of Flammable
Anesthetics
Equipment is NOT suitable for use in the presence of
flammable anesthetics.
Mode of operation
Continuous
Summary of Contents for LLS-LLX
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Page 73: ...LIT 246 CUDA Surgical E 73 80 1 LLS LLX LED 3 6 LED 1 1 LLS LLX LLS LLX LLS LLX 1 2 LLS LLX...
Page 74: ...LIT 246 CUDA Surgical E 74 80 2 2 1 CISPR 11 A RF RF RF 2 2...
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