August 11, 2016
1-5
Introduction
Regulatory notices
This device has been designed and certified to comply with the requirements of
the international standard IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC
60601-1-4, IEC 60601-1-6, IEC 60601-2-26 the United States standard
UL60601-1, and the Canadian standard CAN/CSA22.2 No.601.1.
The device is classified: CLASS IIA, Type BF
100-250 VAC, 50/60 Hz, 80 VA
The above classification is based on the condition that this device is installed and
configured according to the instructions supplied. In order for the complete
system to maintain compliance with the relevant standards, the host computer
must be approved to the Nationally Recognized Testing Laboratory IEC60950-1
2nd Edition standard.
Equipment classifications
Shock Prevention:
Class 1
Degree of Protection Against Harmful Ingress of Water:
Ordinary
Equipment, IPX0
Degree of Safety in the Presence of Flammable Anesthetic Mixture with Air
or with Oxygen or Nitrous Oxide:
Equipment not suitable for use in the
presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide.
Mode of Operation:
Continuous
Federal law restricts this device to sale by or on the order of
a licensed physician.
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