9
8/2021
Underwriters Laboratories (UL) Classifi cation:
UL safety Compliance:
This system is U.L. Classifi ed WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL
HAZARDS ONLY IN ACCORDANCE WITH UL 60601-1/CAN/CSA C22.2 NO. 601.1
EU Conformity and EMC Compliance:
This system meets the requirements of EN-60601-1 so as to conform to the Medical Device
Directive 93/42/EEC (general safety information).
In addition this system conforms with the essential requirements of Annex 111, Module B, of
the Council Directive 2014/53/EU on Radio Equipment (RED) and the mutual recognition of
their conformity, in relation to the essential requirements of:
Article 3.1 (a) Health and Safety
EN 62311 :2008
EN 60950-1 :2006 +A11:2009 + A12:2011 + A1:2010 + A2:2013
Article 3.1(b) EMC
Draft EN 301 489-17 v3.2.0, Draft EN 301 489-1 V2.2.0
Article 3.2 Radio Spectrum
EN 302 567 V2.1.1
Article 3.3 a-i (Special Features)
None are applicable.
This unit uses plug for US: 120V rating 5-15P type only.
This system complies to the above standards only when used with the supplied medical grade
power supply.
Wireless Imaging System
Power Supply
WUH4000
Adapter Technology ATM036T-P050
WUH4060
CUI INC SDM36-12-U-P5
Caution: Make sure the power cord is the correct type that is required in your area.
This system has a universal power supply that allows operation in either 100-120V AC or 200-
240V AC voltage areas (no user adjustment is required).
Use the proper power cord with correct attachment plug type. If the power source is 120V AC,
use a Hospital Grade Power Cord with NEMA 5-15 style plug, labeled for 125 volts AC with UL and
C-UL approvals.
If the power source is a 240 V AC supply, use the tandem (T blade) type attachment plug with
ground conductor power cord that meets the respective European country’s safety regulations.
Classifi cation
- Protection against electrical shock: Class I including AC/DC power.
- Applied parts: no applied parts.
- Degree of safety in the presence of fl ammable anesthetics mixture with air or with oxygen or
with nitrous oxide. Not suitable for use in the presence of a fl ammable anesthetics mixture
with oxygen or with nitrous oxide.
- Mode of operation: continuous
Summary of Contents for FHD-1TX-1RX
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