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Esophageal Stethoscope Temperature Probe 21093A, 21094A, 21095A
With 400 Series Thermistor
Application Note
Description
The Philips Medical Systems esophageal
stethoscope with temperature probe is a
disposable device which provides for accurate
measurement of core body temperature as
well as transmission of heart and lung sounds.
Heart and lung sounds are transmitted across
a thin cuff wall, through the side and distal
openings of the tube. Made of a special
material which optimizes sound transmission
and remains both durable and flexible, the cuff
maintains its integrity and prevents secretion
from entering the tube. For connection to any
standard ear piece, a male luer adapter is
attached to the proximal end of the
esophageal stethoscope. The stethoscope is
19 in. (48.3 cm) long. The tube, the cuff and
luer adapter are made of light weight,
nontoxic, implant tested, pyrogen free
material.
The temperature transducer is in the form of
an electrically insulated thermistor, which is
permanently secured within the lumen of the
esophageal stethoscope. The thermistor itself
is placed toward the distal end of the tube but
not outside the distal end. Leakage current of
the Philips temperature probe (thermistor and
stethoscope) is of a magnitude well within
accepted nonhazardous levels.
Range and Accuracy
The accuracy of the thermister is ±0.1°C
from 25°C to 45°C.
Indications
The Philips esophageal stethoscope
temperature probe is suitable for usage with
Philips Temperature Monitoring Modules via
extension cables.
Directions for Use and Precautions
1. If a patient has to be intubated with an E.T.
tube, perform intubation prior to placing
the esophageal stethoscope.
2. Lubricate the stethoscope prior to
insertion, and place the probe in
accordance with currently acceptable
medical procedures.
3. Verify position of the stethoscope by direct
laryngoscopy or other medical techniques.
4. Align the stethoscope's connector with
cable connector and push firmly to assure a
full contact. Forced mating of the
connectors without proper alignment may
cause damage to the connectors and
interruption in electrical continuity.
5. During surgical procedures which employ
electro-cautery, use currently acceptable
procedures to minimize the situation in
which the thermistor and a lead wire may
function as an alternate path for
radiofrequency current to return to ground,
which may cause localized tissue burns.
Here are several procedures which may
minimize risk of electro-surgical burns:
Keep both active and ground electrodes of
electro-cautery system in close proximity
so that the esophageal stethoscope is
outside of the radiofrequency current field.
Keep the temperature monitor with
associated cables separated from electro-
cautery systems.
Unusual, fast artificial variations in
temperature reading may occur with
concomitant applications of electrocautery
systems.
6. Reuse may cause degradation of physical or
electrical properties. Do not reuse on
another patient due to risk of cross-
infection.
Electromagnetic Compatibility
The electromagnetic compatibility (EMC)
validation of the 21093A, 21094A and 21095A
included testing performed according to the
international standard for EMC with medical
devices. See the Manufacturer's Declaration for
details.
3
Avoiding Electromagnetic
Interference
If electromagnetic interference (EMI) is
encountered there are a number of things that
can be done to mitigate the problem.
• Eliminate the source. Possible sources of
EMI can be turned off or moved away to
reduce their strength.
• Attenuate the coupling. If coupling is
through accessory leads, the interference
may be reduced by moving and/or
rearranging the leads.
• Add external attenuators. If EMI becomes
an unusually difficult problem, external
devices may be of help. A Philips Customer
Engineer can be of help in determining the
need for external devices.
Adverse Reactions
Adverse reactions reported during
applications of esophageal stethoscope with or
without temperature probes include accidental
tracheal; or bronchial intubation accompanied
with airway obstruction, esophageal abrasion,
and tissue burns due to aberrant electro-
cautery RF current pathways.
Contraindications
The use of the esophageal stethoscope may be
contraindicated in neonates and small infants
undergoing tracheostomy or internal jugular
vein catheterization.
Disposal
Follow local regulations for disposal.
Sterile-Disposable
0123
Do not use if
Do not
seal is broken
reuse
Caution
via irradiation
see documentation
Sterilized