English; Electromagnetic Compatibility - Philips 21091A Anwendungsinformation

ENGLISH

Skin Temperature Probe 21091A
With 400 Series Thermistor temperature probe
Application Note
Description
Monitoring of skin surface temperature is a
well accepted procedure for the detection of
hypothermic or hyperthermic conditions. The
Philips Medical Systems skin temperature
probe is designed for placement on the surface
of the skin and consists of a thermistor, plastic
film, and foam covered with a metallic layer.
The surface of the plastic is coated with
medical grade hypoallergenic adhesive suitable
for skin application. The hypoallergenic
adhesive holds the sensor in situ. The foam
thermally insulates the sensor and the metallic
layer reflects external infrared heat energy,
thus providing accurate measurement of body
temperature. Leakage currents of the device is
of magnitude well within clinically acceptable
non-hazardous levels. The device is disposable,
single patient use only and it is packaged
sterile.
Range and Accuracy
The accuracy of the thermister is ±0.1°C
from 25°C to 45°C.
Indications
Philips skin temperature probe is intended to
be used with Philips Temperature Monitoring
Modules via extension cables. Skin probe is
specially designed for monitoring neonates and
infants.
Directions for Use and Precautions
1. Dry skin completely in area of intended
sensor placement.
2. Remove protective paper backing and place
the sensor over previously dried skin area.
3. Align the sensor's connector with the
monitor cable's 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.
4. During surgical procedures which employ
electro-cautery, use currently acceptable
procedures to minimize conditions of the
thermistor and a lead wire functioning as an
alternate path for radio-frequency current
to return to ground, causing localized tissue
burns.
Here are several procedures which may
minimize risk of electro-surgical burns:
Keep both active and ground electrodes of
the electro-cautery system in close
proximity so that the skin temperature
sensor is outside of the radio-frequency
current field.
Keep the temperature monitor with its
associated cables separated from
electrocautery systems.
Unusual, fast variations in temperature
reading may occur with concomitant
applications of electro-cautery systems.
5. Reuse may cause degradation of adhesive
or electrical properties. Do not reuse on
another patient due to risk of cross-
infection.

Electromagnetic Compatibility

The electromagnetic compatibility (EMC)
validation of the 21091A 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.
Adverse Reactions
Adverse reactions reported during
applications of skin temperature probes
include skin abrasion reaction and tissue burns
due to aberrant electro-cautery RF current
pathways.
3
Disposal
Follow local regulations for disposal.
Sterile-Disposable
0123
Do not use if
Do not
seal is broken
reuse
Caution
see documentation via irradiation
Sterilized