User's Manual Part 1

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Contraindications
A contraindication is any circumstance that indicates a form of treatment
may be inappropriate.
• The VS-XHR Sensor is contraindicated for the detection of Heart Rate
due to bigeminal arrhythmias or systoleic arrhythmias.
• The VS-XHR Sensor is contraindicated for use in conjunction with
pacemakers, electrosurgical equipment, and defibrillators.
• VS-XHR Sensor is contraindicated for use in measuring ST segment
shifts.
• VS-XHR Sensor is contraindicated for use in measuring ventricular
ectopic beats, ventricular flutter or fibrillation; or supraventricular
ectopic beats, atrial flutter, or fibrillation.
• VS-XHR Sensor is contraindicated for use with neonatal or infant
subjects whose body mass is 10 kg or less.
• VS-XHR Sensor is contraindicated for patients with current or known
history of dermal allergies, dermal sensitivity to ECG electrodes, or
dermal lesions. Consult ECG electrode manufacturer’s directions for
appropriate ECG electrode type and usage. Discontinue use if dermal
irritation or allergic reaction to ECG electrode occurs.
Warnings
A warning indicates a condition that may endanger the subject.
Pacemaker Patients - This device does not reject pacemaker pulses.
Rate meters may continue to count the pacemaker rate during occurrences
of cardiac arrest or some arrhythmias. Do not rely entirely upon rate
meters to measure heart rate for pacemaker patients. Keep pacemaker
patients under close surveillance.
Magnetic Resonance Imaging (MRI)
DO NOT attempt an MRI (magnetic resonance imaging) if a VS-XHR
Sensor has been affixed. Remove the device prior to MRI.
Affix an MRI Warning wrist band (supplied) to the subject with
instructions to wear it until the VS-XHR Sensor has been removed.
Cardiac Arrhythmias
This devices does not provide alarms that signal the onset or presence of
cardiac arrhythmias, including tachycardia.
Electrosurgical Equipment
Electrosurgery or electrocautery equipment may interfere with or damage
this device. Do not rely on this device to measure heart rate or respiration
rate when electrosurgery equipment is being used.