SunTech Oscar2 - Safety and Effectiveness Considerations; Disposal; Adverse Reactions

Safety and Effectiveness Considerations
The following safety and effectiveness issues are to be considered
prior to the usage of the Oscar 2 unit.
•Thisdeviceisdefibrillatorprotected.
NOTE:NoprecautionsspecifictotheOscar 2 are required during
defibrillation, and defibrillation discharge has no effect on the Oscar 2.
•Themonitorisintendedforusefollowingconsultationandinstructionbya
physician.
•Thereliabilityofthedeviceisdependentuponconformancewiththeoperation
and service instructions, as detailed in this manual.
•Thisdevicehasbeendesignedforuseonpatientswithnormalsinusrhythms.
•Theinterpretationofbloodpressuremeasurementsshouldonlybemadebya
physician. The accuracy of any blood pressure recording may be affected by
the position of the subject, his or her physical condition, and use outside the
operating instructions detailed in this manual.
•Safetyandeffectivenessonpregnantwomenandneonates
have not been tested.
Disposal
This symbol indicates that the monitor contains materials (such
as electrical components) which are hazardous. Please return to
SunTechMedicalforproperdisposal.
Adverse Reactions
Allergicexanthema(symptomaticeruption)intheareaofthecuffmayresult,
including the formation of urticaria (allergic reaction including raised edematous
patches of skin or mucous membranes and intense itching) caused by the fabric
material of the cuff.
Petechia (a minute reddish or purplish spot containing blood that appears in the
skin) formation or Rumple-Leede phenomenon (multiple petechia) on the forearm
following the application of the cuff, which may lead to Idiopathic thrombocytopenia
(spontaneous persistent decrease in the number of platelets associated with
hemorrhagic conditions) or phlebitis (inflammation of a vein) may be observed.
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