9
9/2021
Biohazards
To prevent spreading of infections, this device should only be used in environments where
biological decontamination can be successfully performed.
Returned Product
After troubleshooting, if problems persist, disinfect the device and return it to FSN using the
original packaging. Include the accessories that came with the device in the return shipment.
Please enclose a brief explanation of the malfunction.
Contact FSN Medical Technologies for a Return Authorization Number and instructions, prior to
returning the device.
Accessories
Use only accessories specifi ed by the manufacturer, or sold with the device.
Classifi cation for Safety Compliance
- Protection against electric shock : Class I including AC/DC adapter. This medical equipment is in
accordance with ANSI/AAMI ES60601‐1 (2005) + AMD 1 (2012) and CAN/CSA‐C22.2 No. 60601‐1
(2014) in regards to electric shock, fi re hazards, and mechanical hazard.
- 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.
- For critical applications, it is recommended to have a replacement device available.
- Mode of operation : Continuous.
Notice to the user:
Any serious incident that has occurred in relation to the device should be reported to the manu-
facturer and the competent authority of the Member State in which the user and/or patient is
established. Contact your local FSN Medical Technologies sales representative for information on
changes and new products.
