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Appendix 1
Product Classification:
• According to the type of protection against electrical shock, this device is
classified as a Class II Equipment, and Type B Equipment that is powered by an
external electrical power source.
• According to the degree of protection against harmful ingress of water
this system is classified as Ordinary Equipment (IPXO: without protection
against ingress of water)
•
CAUTION:
This device has been tested and confirmed to comply with the
IEC 60601-1-2:2007 and essential requirements of Medical Device Directive
93/42/EEC. However with the proliferation of radio-frequency transmitting
equipment, and other sources of electrical noise in a healthcare environ-
ment, high levels of interference may induce an abnormal stoppage or other
disruption of this device. This device may also cause adverse effects in other
nearby equipment. It is strongly recommended that this device be isolated
from other electromagnetic equipment when in use.
• This system is classified as Equipment not Suitable for use in the presence
of a Flammable Anesthetic Mixture with Air or Oxygen or Nitrous Oxide.
• According to the mode of operation this system is classified as Equipment
that can be used for Continuous Operation.
•
CAUTION:
In the USA, Federal Law restricts this device to sale, by or on the
order of a physician.
• Unit is packaged for transportation by common carrier.
