Indications for Use

The Smartdop™ XT6 is intended for use in the noninvasive evaluation of peripheral vascular pathology in patients. It detects systolic pressures for Ankle Brachial Index (ABI), Toe Brachial Index (TBI), and arterial and venous blood flow in extremities. Measurements are provided utilizing cuffs, photoplethysmography (PPG) and/or Doppler probe. The foot temperature probe (optional) provides skin temperature readings on the foot. Collected data is captured and stored with the Smart-XT-Link6 software that includes capabilities to print waveforms and export into the facility's electronic health records.

Contraindications

The Smartdop™ XT6 is not intended to be used in fetal applications or used inside the sterile field.

CAUTION: The Smartdop™ XT6 should only be used by skilled personnel.

CAUTION: Perform ultrasound testing/procedures prudently using the principle of ALARA (As Low As Reasonably Achievable).

CAUTION: The Smartdop™ XT6 has not been evaluated for safety and compatibility in the MR environment. The Smartdop™ XT6 has not been tested for heating or migration in the MR environment.

For a complete listing of indications, contraindications, cautions and warnings, please refer to the operation manual provided with this product.