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Repair
Do not attempt to service the medical monitor yourself, as opening or removing covers may
expose you to dangerous voltages or other hazards, and will void the warranty. Refer all servicing
to qualifi ed service personnel. Unplug the medical monitor from its power source and refer
servicing to qualifi ed personnel under the following conditions:
- If the power cord or plug is damaged or frayed.
- If liquid has been spilled into the medical monitor.
- If objects have fallen into the medical monitor.
- If the medical monitor has been exposed to rain or moisture.
- If the medical monitor has been subjected to excessive shock by being dropped.
- If the cabinet has been damaged.
- If the medical monitor seems to be overheated.
- If the medical monitor emits smoke or abnormal odor.
- If the medical monitor fails to operate in accordance with the operating instructions.
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 monitor and return it to FSN using the
original packaging. Include the accessories that came with the monitor 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 medical monitor.
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 monitor 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.
