Contraindications - Covidien SomaSensor Instructions D'emploi

Pediatric Single-Use Regional Oxygen Saturation Sensor (English GB)
For use with INVOS 5100/5100B/5100C Systems ONLY. The SomaSensor
®
been designed for cerebral – somatic monitoring of site-specific regional oxygen saturation (rSO
weighing < 40 kilograms. For additional information regarding setup and use of the INVOS System, consult the
Operations Manual.
CONTRAINDICATIONS: None
WARNING: The sensor is designed for single use only and may not be reused. Reuse may cause inaccurate
readings, erratic readings, or no readings at all. Also, reuse may cause an increased risk of cross-contamination
among patients. Do not autoclave or gas sterilize the sensors.
WARNING: The sensor is designed for external use only as described in the instructions. Do not use the sensors
internally for any reason.
WARNING: Do not immerse the INVOS System or sensor in any liquids as they may cause electric shock hazard
or damage the device.
WARNING: Do not use the INVOS System in the presence of flammable anesthetics or in other flammable
environments.
PRECAUTION: INVOS readings represent a small volume of tissue beneath the sensor and may not reflect
oxygenation disturbances that occur elsewhere.
PRECAUTION: Make sure all connectors are fully engaged and free from moisture. Moisture intrusion may cause
inaccurate readings, erratic readings or no readings at all.
PRECAUTION: Different INVOS System sensors (adult, pediatric and neonatal) cannot be used simultaneously
on the same monitor.
PRECAUTION: Use only Covidien recommended or provided accessories. Use of the INVOS
System with any other sensor will compromise accuracy.
PRECAUTION: Use care when placing or removing sensor. Do not place on broken or undeveloped skin.
PRECAUTION: If present, the following may cause inaccurate readings:
o "Cardiogreen," "Indigo Carmine," "Methylene Blue" or other intravascular dyes
o Carboxyhemoglobin or other dyshemoglobins
o Hemoglobinopathies
o Conjugated hyperbilirubinemia (direct)
o Myoglobin (Mb) in muscle tissues
PRECAUTION: Do not place the sensor on regions with severe tissue edema to reduce the possibility of skin
lesions.
PRECAUTION: Use of an electrosurgical/electrocautery instrument in the vicinity of the INVOS System may
interfere with the signal and result in no readings.
PRECAUTION: Environments with excessive ambient light such as bright sunlight or strong operating room
lighting may require loosely covering the area of the sensor with an opaque drape.
PRECAUTION: To avoid pressure sores do not apply pressure (e.g. headbands, wraps, tape) to sensor.
PRECAUTION: Sensors do not need to be removed for X-ray or CT Scan. However, sensors will appear on
image. Sensors must be removed for MRI.
Pre-use Check: Remove the sensor from the package and examine for visual signs of damage. If any signs of
damage are observed, select another sensor.
PRECAUTIONS
INSTRUCTIONS FOR USE
disposable sensor Model SPFB has
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) in pediatric patients
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