WARNING
MR UNSAFE. Do not use the LuMon System with magnetic resonance (MR) equipment. Induced current in
the belt and belt connector could potentially cause patient burns, and the MR image quality could be affected
by the LuMon System and the LuMon System by the MR equipment.
WARNING
During normal operation (except intra-hospital transport), it is recommended that the monitor is always
connected to AC mains power.
WARNING
If the monitor is operated on an AC mains power source with a depleted battery and the AC mains power is
subsequently disconnected or lost, the monitor may shut down immediately.
WARNING
Do not connect the LuMon Monitor to an electrical outlet controlled by a wall switch, because the LuMon
Monitor may be unintentionally disconnected from AC mains power and, once the battery is depleted,
accidentally switch off.
WARNING
To avoid risk of electrical shock, this equipment must be connected to AC mains power with protective earth.
Ensure that power and protective ground lines are connected correctly. As a precaution connect this
equipment directly to fixed wall sockets within hospitals or hospital type facilities only. Neither connect it to
portable sockets nor use extension cords or connect it to publicly accessible AC mains power.
For US, respectively Japan: Grounding reliability can only be achieved when the LuMon Monitor is connected
to an equivalent receptacle marked HG (Hospital Grade), respectively HGJ (Hospital Grade Japan).
WARNING
Accessory equipment (e.g. a PC or an externally powered USB memory device) connected to the LuMon
Monitor certified according to the applicable IEC standards (e.g. IEC 60601-1, UL 60601-1,
CSA C22.2 No. 601-1-M90, or IEC 60950). Furthermore, all resulting configurations must comply with the IEC
standard 60601-1 systems requirements. Anyone who connects accessory equipment to the LuMon Monitor
configures a medical system and is, therefore, responsible for ensuring that the resulting system complies with
the IEC standard 60601-1 systems requirements and the electromagnetic compatibility standard IEC 60601-1-
2. Connection of accessory equipment to the LuMon Monitor`s data ports is to be performed by qualified
personnel.
WARNING
SensorBelts and LuMon Belts, are for single patient use only do not attempt to reuse, clean, disinfect, or
sterilize. Using a belt on more than one patient increases the risks of infection and cross-contamination. Using a
belt whose
belt time
has expired may compromise its biological integrity and functionality as well as the overall
system performance. Dispose of the belt when the
belt time
has elapsed or after ending monitoring for a
patient.
WARNING
Do not apply SensorBelts, LuMon Belts, ContactAgent, LuMon Contact Spray or NeoContactAgent on
open, uncovered wounds. Doing so increases the risks of infection and tissue irritation.
CAUTION
Biological evaluation has been conducted in compliance with ISO 10993-1 on the belts and the contact
agents/sprays for their use on the intact skin of an individual patient for up to 30 cumulative days. Nevertheless,
on rare occasions erythema (skin redness) has been observed in neonates and infants on the skin area where
the belt has been applied. Should skin redness occur, it will generally resolve within a few hours after belt
.
WARNING
Wipe off ContactAgent residue from the patient after belt removal.
WARNING
Clean and disinfect the reusable parts of the LuMon System
monitoring for a patient and before use with a new patient, and regularly according to institutional policy during
use with a single patient. Before each use, prepare the LuMon System as described herein. Failure to do so
increases the risk of cross contamination and patient infection.
WARNING
All parts of or removed from the LuMon System must be considered potentially contaminated and a source of
infection risk. Dispose of all parts removed from the device according to local regulations for medical waste.
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