Vascular Dopplers
Surgical Dopplers
Fetal Dopplers

INDICATIONS & PRECAUTIONS

Indications

The Smartdop® XT 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-Link software that includes capabilities to print waveforms and export into the facility's electronic health records.

Contraindications

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

Precautions

  • Do not perform any modifications to the unit.
  • Do not place near water or other liquid, where atmospheric pressure, temperature, humidity, ventilation, sunlight, dust, salt, or sulfur, etc. may cause damage or where chemicals are stored or gas may be generated.
  • Do not drop or place in an area where the unit may fall.
  • Protect the unit from vibration and shock during transport.
  • The Doppler box should not have direct contact with the patient or be placed in the sterile area. The Doppler box cannot be sterilized or reprocessed.
  • Do not leave patient unattended during operation.
  • Do not use simultaneously with an electrocautery defibrillator, other ultrasonic device, or a mobile phone.
  • Do not use in area where a strong electromagnetic field is present. Doing so may cause incorrect measurements.
  • Use only designated Smartdop® XT accessories.
  • Use the Smartdop® XT as specified in the operation manual and under the operating conditions stated in the product specifications.
  • In case of emergency or unexpected situations, stop cuff inflation by pressing the STOP button the front panel, disconnect the tubing from the unit, and turn the unit off.
  • Do not use excessive force when disconnecting cables.
  • The Doppler box and noninvasive probes should be cleaned following any patient contact.
  • Clean probes with a recommended probe cleaner before use.
  • The probe transducer tip is thin and delicate. Please handle with care and use the probe cap when not in use.
  • Use ultrasound gel. Other materials such as baby oil or cream may produce incorrect sounds or damage the probe.
  • The ultrasound gel enclosed is non-sterile and should only be used noninvasively.
  • Incidence of allergy: disconinue use of ultrasound gel if an allergic reaction occurs.
  • Repairs should only be attempted by authorized personnel.

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

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

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. Rx only.

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




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