v
NOTE
In addition to these precautions, cautions and warnings are
located in paragraphs 3.1 (Page 3-1), 4.0 (Page 4-1), Section
6 (Pages 6-1 through 6-10) and Appendix B (Page B-2).
CAUTION
Federal law in the USA and Canada restricts this device to sale by, or on the
order of, a licensed medical practitioner.
NOTE
Use only Invivo Research Fiber Optic Sensors with this monitor.
MRI SERVICE PRECAUTIONS
This monitor is not intended for use in the presence of
FLAMMABLE ANESTHETICS
.
An
explosion hazard exists.
Never immerse the monitor in any fluid or attempt to clean it with liquid cleaning agents.
An
electrical hazard exists.
Do not remove the monitor's cover.
A shock hazard exists
. Refer servicing to qualified personnel
only. No repair should be undertaken or attempted by anyone not having a thorough understanding
of the repair and safety assurance of patient monitors.
Risk of RF current burn.
Cables which become inadvertently looped during MRI act as conductive
lines for RF induced currents. When lead wires or other cables form conductive loop in contact with
the patient's tissue, minor to severe burning can result.
Perform the following to minimize risk of RF current burn:
1.
Place cables and lead wires neatly in straight alignment with no looping.
2.
Keep the length of lead wires and patient cable within the bore to a minimum.
3.
RF burn risk increases when multiple sensors/cables are in use. Such combinations
are not recommended.
4.
The high radio frequency (RF) power used in MR scanning poses an ever-present risk
of excessive heat at the monitoring sites and, therefore, the risk of RF current burn.
Should power levels greater than S.A.R. of 4 w/kg peak (0.4 w/kg average) be
used, the risk of patient burn greatly increases.
As a result, monitoring of ECG
or Respiration (derived from ECG leads) at power levels of greater than 4 w/kg peak
(0.4 w/kg average) is not recommended for the general patient population. Such
monitoring should only be attempted on conscious patients with good temperature
reflex so they may warn the operator of excessive heat at the monitoring sites.
5.
High RF Power may cause patient heating or burns. For scans with average
S.A.R. > 1 w/kg, limit scan time to 5 minutes and pause at least 3 minutes
between scans to allow ECG Cable to cool.
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