Warnings And Contraindications - SunTech Tango+ STRESS BP Gebrauchsanweisung

6

Warnings and Contraindications

CAUTION: Federal (U.S.) law restricts this device to
sale by or on the order of a physician.
DO NOT USE THE MONITOR IF it
has failed its diagnostic self test or if it
displays a greater than zero pressure
with no cuff attached or a value of
saturation with no sensor attached.
The values displayed by such a unit
may be inaccurate.
DO NOT USE ON NEONATES, CHILDREN, and
patients known to be readily susceptible to bruising.
DO NOT ATTACH THE CUFF to a limb being used
for IV infusions as the cuff inflation can block the
infusion, causing harm to the patient.
DO NOT ATTACH THE PULSE OXIMETER
SENSOR to the same limb as the CUFF or any other
blood flow restrictors. Loss of monitoring can occur
due to the hindering of pulse measurements.
DO NOT USE IN THE PRESENCE OF FLAMMABLE
anesthetics; this could cause an explosion.
DO NOT IMMERSE the monitor in any fluid, place
fluids on top of, or attempt to clean the unit with any
liquid detergents or cleaning agents. This may cause
an electrical hazard. Refer to Maintenance & Cleaning
for instructions on cleaning. If any of these situations
occur, please contact SunTech Medical.
DO NOT REMOVE UNIT COVERS.
Doing so may expose hazardous voltage and cause
electrical shock. The monitor does not contain any
user serviceable components. Refer to Maintenance &
Cleaning for service instructions.
DO NOT MAKE REPAIRS YOURSELF: No repair
should be undertaken or attempted by anyone not
having been service trained by SunTech Medical or
having a thorough understanding of the repair and
operation of automatic blood pressure equipment.
(Substitution of a component different from that
supplied might result in measurement error).
DO NOT allow the pulse oximeter sensor to become
wet.
DO NOT use a damaged pulse oximeter sensor.
DO NOT CONNECT THE MONITOR TO
EqUIPMENT THAT DOES NOT MEET EN60601-1.
WHEN THE MONITOR IS ATTACHED TO A
PATIENT, THE MONITOR'S RS-232 CONNECTOR
CAN ONLY BE CONNECTED TO EqUIPMENT
THAT MEETS EN60601-1.
PRECAUTIONS
Observe the patient carefully during the procedure.
Ensure pressure compatibility to all patients. If any
abnormality occurs, either in the unit or the patient,
suspend the operation immediately and disconnect
the cuff, pulse oximeter sensor, and electrodes (if
applicable) from the patient.
Accuracy of any blood pressure recording or oxygen
saturation measurement may be affected by the
position of the subject, his or her physical condition
and use outside of the operating instructions detailed
in this manual. The interpretation of blood pressure
and oxygen saturation measurements should only be
made by a physician.
Safety and effectiveness in pregnant women, children
under the age of 18 years of age and neonates have
not been established.
Only use pulse oximeter sensors supplied by SunTech
Medical.
Check the application site of the pulse oximeter
sensor frequently to determine the positioning of the
sensor and the circulation and skin sensitivity of the
patient.
Factors that may affect the accuracy of pulse
oximetry:
• electrosurgical interference
• arterial catheters, blood pressure cuffs, infusion
lines, etc.
• moisture in the sensor
• improperly attached sensor
• incorrect sensor type
• poor pulse quality
• venous pulsations
• anemia or low hemoglobin concentrations
• cardiovascular dyes
• sensor not at heart level
ERSE REACTIONS
Adverse Reactions
In the area of the cuff or sensor, allergic exanthema
(symptomatic eruption) may result, including the
formation of urticaria (allergic reaction including raised
edematous patches of skin or mucous membrane and
intense itching) caused by the fabric
material of the cuff, sensor, or electrodes.
Following the application of the cuff, petechia (a
minute reddish or purplish spot containing blood
that appears in the skin) formation or Rumpel-Leede
phenomenon (multiple petechia) on the arm, 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.