4
We at
Limbs & Things Ltd
of
Sussex Street, St. Philips, Bristol, BS2 0RA
Declare under our sole responsibility that the product described below:
Brand and Model
Name
FLS (Fundamentals of Laparoscopic Surgery) Trainer, Part
numbers: 50301,50302, 50306
Has been tested and is in conformity with the following standards:
SUBJECT
STANDARD
Electrical Safety
LVD Directive – 2014/35/EU
EN 61010: 2010 + A1:2019 Clause
5,6,7,8,9,10,11,12,13,14,15,16 & 17
Electromagnetic
Compatibility
EMC Directive – 2014/30/EU
Conducted emissions:
EN 55011:2009 + A1:2010
Radiated emissions:
EN 55011:2009 + A1:2010
Voltage Fluctuations (Composite Video and USB Mode):
EN 61000-3-3:2013
Electrostatic Discharge (Composite Video and USB Mode)
EN 61000-4-2:2009
EFT/Bursts (Composite Video and USB Mode)
EN 61000-4-4:2004 + A1:2010
Surge Immunity (Composite Video and USB Mode)
EN 61000-4-5:2006
Conducted Immunity (Composite Video and USB Mode)
EN 61000-4-6:2009
Dips & Interruptions (Composite Video and USB Mode)
EN 61000-4-11:2004
Radio performance
N/A
RoHS
RoHS - Directive 2011/65/EU, as amended (by Directive
2015/863)
I hereby declare that the equipment named above has been designed to comply with the relevant
sections of the above referenced Standards.
Signed
Nick Hull
Signature
..................
Position
Managing Director
Location
Limbs & Things, Bristol, England
Date
..................
EC DECLARATION OF CONFORMITY
In accordance with ISO IEC 17050-1 : 2010
13 July 2021