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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 BF Equipment that is powered by
anexternal electrical power source.
• According to the degree of protection against harmful ingress of water
this system is classified as Ordinary Equipment (IP22: Protected against
foreign objects equal to or greater than 12.5mm and against falling drops of
water when enclosure tilted up to 15°.)
•
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
environment, 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.
• For reusable medical devices (such as the pump), it will have an estimated
useful life of 3 years. For disposable medical devices (such as the dressings
and canisters), the shelf life expires at their respective expiration dates,
which can be found on the package labeling.
• Unit is packaged for transportation by common carrier.