V Series Operating Instructions 13 - 9
Temperature (Temp) Measuring Temperature
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 radio frequency 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 procedures employing electro-cautery, 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 temperature sensor is outside the radio-frequency 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
electro-cautery system.
WARNING: Temperature probes are sterile unless unit container is opened or
damaged.
CAUTION: Temperature probes are for single use only. Reuse may cause a risk of
contamination and affect the measurement accuracy. Destroy after
single use. Do not re-sterilize.
13.4.3 Esophageal/Rectal Temperature Probe with 400 Series
Thermistor
Description (P/Ns 0206-03-0209-02, 0206-03-0212-02)
Hypothermia and hyperthermia are well recognized clinical conditions necessitating temperature
monitoring. The economical and disposable Esophageal/Rectal Temperature Probe is a sensitive and
accurate temperature transducer, to be used clinically where continuous temperature monitoring is
required.
The temperature sensor is in the form of an electrically insulated “400” series thermistor, which is
permanently secured within a PVC tube. The bullet tipped PVC tube provides for atraumatic insertion.
The thermistor is placed at the distal end of the tube. The accuracy of the thermistor is ± 0.2°C in the
range of 5 - 45°C.
The assembly is disposable, single use only, and packaged sterile. It is available in sizes 9 and 12
French.
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