Passport® - Mindray

Temperature Monitoring Temperature Probes
Indications
The esophageal stethoscope with temperature sensor is indicated where patient temperature
monitoring is desired along with accurate heart and lung sound monitoring. The sensor is
designed for insertion into the esophagus.
Contraindications
The use of the esophageal stethoscope may be contraindicated in neonates and small infants
undergoing tracheostomy or internal jugular artery catheterization or remote surgical
procedures.
Adverse Reactions
Adverse reactions reported during applications of esophageal stethoscopes with or without
temperature sensors include accidental tracheal or bronchial intubation accompanied with
airway obstruction, esophageal abrasion and or perforation, pharyngeal abrasion and
tissue burns due to aberrant electro-cautery radiofrequency current pathways.
Directions for Use and Precautions
1. If a patient has to be intubated with an endotracheal tube, perform the intubation prior
to the placement of the esophageal stethoscope.
2. Lubricate the stethoscope prior to the insertion and place the stethoscope in accordance
with currently acceptable medical procedures.
3. Verify position of the stethoscope by direct laryngoscopy or other acceptable medical
techniques.
4. Align the sensor’s connector with the monitor cable’s connector and push firmly to assure
full contact. Forced mating of the connectors without proper alignment may cause
damage to the connectors and interruption in electrical continuity.
WARNING: During the surgical procedures which employ electrocautery,
use currently acceptable procedures to minimize
conditions of the thermistor and lead wires functioning as
an alternate path for radio-frequency current to return to
ground, causing localized tissue burns. Procedures which
may minimize risk of electro-surgical burns are: keep both
active and ground electrodes of the electro-cautery system
in close proximity so that the sensor is outside the radiofrequency
current field; keep temperature monitor with its
associated cables separated from electro-cautery systems.
Unusual, fast artificial variations in temperature readings
may occur with concomitant applications of the electrocautery
system.
WARNING: Sterile unless unit container is opened or damaged.
CAUTION: Single use.
Destroy after single use.
Do not resterilize.
Federal (U.S.A.) law restricts this device to sale by or on the
order of a physician.
Passport V Operating Instructions 0070-10-0704-02 8 - 5