Safety And Effectiveness Considerations; Indications For Use; User Responsibility - SunTech Tango+ STRESS BP Gebrauchsanweisung

Safety and Effectiveness Considerations

Indications for Use

Consider the following safety and effectiveness issues prior to using the Tango+
Stress Test Blood Pressure Monitor:
• Use Tango+ only with adult patients, while they undergo a cardiac or exercise
stress test under the supervision of a physician. Ensure that appropriate
resuscitation equipment and personnel are available at all times during the
procedure.
• The Tango+ BP monitor is defibrillator protected. The pulse oximeter is not
defibrillator protected.
• All alarms indicate an increasing risk of injury if the test is continued.
• The reliability of the device depends upon conformance with the operation and
service instructions, as detailed in this manual.

User Responsibility

Your Tango+ is designed to perform in conformity with the description thereof
contained in this operation manual and accompanying labels and inserts, when
assembled, operated, maintained and repaired in accordance with the instructions
provided. It is your responsibility to:
• Check calibration of this device annually.
• Never knowingly use a defective device.
• Immediately replace parts that are broken, warn, missing, incomplete, damaged
or contaminated.
• Contact the nearest factory approved service center should repair or replacement
become necessary. A list of approved service centers appears on page 38 or on
our website at www.SunTechMed.com.
• The reliability of the device depends upon conformance with the operation and
service instructions, as detailed in this manual.
Further, the user of the device bears sole responsibility for any malfunction that results
from improper use, fault maintenance, improper repair, damage or alteration by
anyone other than SunTech Medical or authorized service personnel.
is a non-invasive multi-parameter
monitor measuring blood pressure and
oxygen saturation for use in cardiac
or exercise stress testing. It measures
and displays an adult patient's systolic
and diastolic blood pressure and the
percent oxygen saturation of arterial
blood.
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