English - Philips 21090A Anwendungsinformation

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Esophageal/Rectal Temperature Probe 21090A, M1837A
With 400 Series Thermistor
Application Note
Description
Hypothermia and hyperthermia are well
recognized clinical conditions necessitating
temperature monitoring.
Philips Medical Systems' 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 sensor is designed for insertion
into esophagus or rectum and consists of an
electrically insulated thermistor permanently
secured within a PVC tube. The bullet tipped
PVC tube provides atraumatic insertion.
Leakage current of the temperature probe
(thermistor and PVC tube) is well within
clinically accepted non-hazardous levels. The
temperature probe is disposable, single patient
use only, packaged sterile and available in 9F
and 12F size.
Range and Accuracy
The accuracy of the thermister is ±0.1°C
from 25°C to 45°C.
Indications
Esophageal/Rectal temperature probe is
intended to be used with Philips Temperature
Monitoring Modules via extension cables
having either 1/4 inch phone jack or two-pin
connectors.
Directions for Use and Precautions
1. If a patient has to be intubated with an E.T.
tube, perform intubation prior to placing
the temperature sensor into esophagus.
2. Lubricate the temperature sensor prior to
insertion, and place the probe in
accordance with currently acceptable
medical procedures.
3. Verify position of the sensor by acceptable
medical procedures.
4. Align the sensor's connector with the
monitor cable's connectors 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 the surgical procedures which
employ 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 sensor is outside of
the radio-frequency current field.
Keep the temperature monitor with its
associated cables separated from
electrocautery systems.
Unusual, fast artificial variations in
temperature readings may occur with
concomitant applications of the
electrocautery system.
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 21090A and M1837A
included testing performed according to the
international standard for EMC with medical
devices. See the Manufacturer's Declaration for
details.
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.
3
Adverse Reactions
Adverse reactions reported during
applications of these sensors include:
accidental tracheal or bronchial intubation
accompanied with airway obstruction,
esophageal or rectal abrasion and or
perforation, pharyngeal abrasion, and tissue
burns due to aberrant electro-cautery RF
current pathways.
Disposal
Follow local regulations for disposal.
Contraindications
The use of the esophageal/rectal sensor may
be contraindicated in neonates and small
infants undergoing tracheostomy or internal
jugular vein catheterization and laser surgical
procedures.
Sterile-Disposable
0123
Do not use if
Do not
seal is broken
reuse
Sterilized
Caution
via irradiation
see documentation