ZeroWire® Embedded Technology | 25
ZeroWire® Embedded Technology
Note: Information and procedures in this section apply only to use of Radiance Ultra displays configured with the
optional pre-installed embedded ZeroWire Receiver.
Warnings and Cautions
This product is a Class I medical device according to M.D.D. in Europe. No modifications are allowed.
This product is a Class II medical device in the United States and Canada. No modifications are allowed
.
This equipment/system is intended for use by healthcare professionals only.
Federal law restricts this device to sale by or on the order of a medical practitioner.
These are the European countries that accept CE marked devices: Belgium, Bulgaria, Croatia, Cyprus, Germany,
Hungary, Iceland, Macedonia, Montenegro, Norway, Romania, Slovakia, Spain, Switzerland and United Kingdom.
Safety Compliance:
This product is T.U.V. approved with respect to electric shock, fire and mechanical hazards only in
accordance with CAN/CSA C22.2 No. 60601-1 and ANSI/AAMI ES60601-1.
Safety Compliance:
This device meets the requirements of EN60601-1 so as to conform to the Medical Device Directive 93/
42/EEC and 2007/47/EC (general safety information).
Radio Approval:
This device meets the requirements of EN 302 065 V1.2.1 and conforms to Radio and
Telecommunications Terminal Equipment (R&TTE) Directive 1999/5/EC.
FCC Identification: UK2-SII-SK63102, UK2-SII-SK63101
Industry Canada: 6705A-SIISK63102, 6705A-SIISK63101
The ZeroWire Transmitter complies to the above standards only
when used with the supplied medical grade
power supply:
Intended Use and Contraindications
Intended Use
The Radiance Ultra series ZeroWire Embedded and ZeroWire G2 is a paired wireless video communication
transmitter and receiver, intended for delivery of video signals from a source such as an endoscopy camera/
processor, or other video source over a radio-frequency link to a ZeroWire Receiver for display of images during
endoscopic and general surgical procedures. The Radiance Ultra series and ZeroWire G2 wireless video system is
a non-sterile reusable device not intended for use in the sterile field.
Contraindications
1. This equipment may not be used in the presence of flammable anesthetics mixture with air, oxygen or
nitrous oxide.
2. No part of this product may come in contact with a patient. Never touch the product and a patient at the
same time.
Warnings
Do not use in MR environments.
For mission critical applications, we strongly recommend that a replacement ZeroWire transmitter and
receiver pair, and a DVI cable, be immediately available. Additionally, we recommend that a display that
is hard wired to the video source be immediately available whenever a surgical procedure is in progress.
At any time, a minimum separation of 20 cm must be maintained from the operating device and the user
or patient.
Model ZeroWire
Power Supply Ault MW172KB2400B02 or GlobTek GTM91120-3024-T3A
AC Input 100 to 240 Volts at 50 to 60 Hz
DC Output Ault 24 Volts at 0.75 Amps / GlobTek 24 Volts at 1.25 Amps
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