Cuda surgical LLS-LHD-30 Manual Del Usuario página 3

1. INTRODUCTION
Thank you for the purchase of a new Wireless LED Headlight Camera System!
The Wireless LED Headlight Camera System is an LED headlight-mounted surgical camera
used to capture still and video images of surgical procedures.
You have chosen the best and we would like to make sure you receive optimal results with
your new camera system through correct operation.
1.1. Indications for Use
The LLS-LHD-30 is intended to display and record surgical procedures. This device is
not intended to diagnose, prevent, monitor, treat or alleviate disease, injuries or
handicaps, nor for the investigation, replacement or modification of the anatomy or of a
physiological process, and is not to be used with or as an endoscope or related system.
The LLS-LHD-30 has no essential performance as defined by IEC 60601-1. Users are
advised that should this system fail to operate, have suitable backup systems available
for any procedure in which this device may be used.
1.2. Contraindications
There are no know contraindications associated with this device.
1.3. Function of Design
The Wireless LED Headlight Camera System comprises of a Recording Unit, HD
Camera, Wireless HD Video Receiver, and the base.
• The Main Recording unit is powered by two rechargeable lithium-ion batteries and
can be attached to the operator via rear clip.
• The HD camera can be attached to a headlight through various connectors
depicted later in this manual and is also connected to the main recording unit.
• The HD video receiver is connected to a monitor.
• Once communication between the main recording unit and the wireless HD video
receiver has been established, images and video captured by the HD camera can
be displayed on a remote monitor.
1.4. Classifications
Requirements
Radio Spectrum
EMC
Safety
Health
General
®
LIT-247 -
CUDA SURGICAL
Rev. C
Standard
ETSI EN 301 893 V1.6.1
ETSI EN 301 489-1 V1.8.1
ETSI EN 301 489-17 V2.1.1
FCC 47 CFR Part 15 E
EN 60950-1:2006 + A11:2009 +
A1:2010
EN 62311:2008
CE Directive 1999/5/EC, RoHS
2011/65/EU
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