Masimo Centroid Mode D'emploi page 3

Centroid™
Patient Position Tracker
Single patient use only
Prior to using this sensor, the user should read and understand the Operator's Manual for the Device and this
Directions for Use.
INDICATIONS
The Centroid™ System is intended for monitoring the orientation and activity of patients. The Centroid System is intended
to provide alerts when patient orientation or activity deviates from parameters set by healthcare providers. The Centroid
System is indicated for monitoring the orientation and activity of patients including those susceptible to pressure ulcers.
The Centroid System is intended for use in healthcare environments.
The Centroid System is also indicated for the measurement of respiration rate of adults in healthcare environments.
CONTRAINDICATIONS
Centroid sensors are contraindicated for patients who exhibit allergic reactions to adhesive tape.
DESCRIPTION
Centroid sensors are battery powered, disposable sensors that can track the patient's posture, orientation and activity.
The sensors are intended to transmit data wirelessly via Bluetooth to the paired Masimo® device.
Note: Centroid sensors are designed to be compatible with specific Masimo devices. See Compatibility section.
WARNINGS, CAUTIONS, AND NOTES
• Centroid sensors are to be used with specific monitors. Verify compatibility before use to ensure the sensors function properly.
• The Centroid sensor should be free of visible defects, discoloration and damage. If the sensor is discolored or damaged,
discontinue use. Never use a damaged sensor or one with exposed electrical circuitry.
• Avoid contact with the sensor during defibrillation.
• Do not modify or alter the Centroid sensor in any way. Alteration or modification may affect performance and/or accuracy.
• Do not use the Centroid sensor during surgical procedures.
• Do not use the Centroid sensor in the presence of flammable anesthetics or other flammable substances in combination with air,
oxygen-enriched environments or nitrous oxide to avoid risk of exposure.
• Do not use the sensor during MRI scanning or in a MRI environment as it may result in physical harm.
• The Respiration Rate (RR) feature available on the Centroid system does not provide alarms therefore it should be used for
informational purposes only.
• The Respiration Rate (RR) feature should not be used as the sole basis for medical decisions. It must be used in conjunction with
clinical signs and symptoms.
• Do not use Centroid as an apnea monitor. The Centroid system does not have alarms to alert you when patients are not breathing
properly.
• Always ensure settings including alarms are appropriate for each patient and facility's protocols prior to use. Centroid has not
been validated for ambulatory use or for use on pediatric populations.
• Do not place the Centroid sensor on garments. Apply directly to the skin. Choose a site on the chest where the skin is clean and
dry prior to sensor placement.
• Do not use additional tape to secure the sensor to the site. Use of additional tape can cause skin damage, and/or pressure
necrosis or damage the sensor.
• Check the sensor site to ensure skin integrity and to avoid damage or irritation to the skin.
• The site must be checked frequently or per clinical protocol to ensure adequate circulation, skin integrity and correct alignment.
• Exercise caution with poorly perfused patients. Assess site frequently and move the sensor if there are signs of tissue ischemia.
• Misapplied sensors or sensors that become partially dislodged may cause incorrect readings.
• Inaccurate readings may be caused by misaligned sensor and/or EMI interference.
• Inaccurate or no Respiration Rate (RR) readings may be caused by: improper placement; motion induced artifact.
• Periodically check the sensor site for proper adhesion to minimize the risk of inaccurate Respiration Rate (RR) readings or no
readings.
• Do not attempt to reuse on multiple patients, reprocess, recondition or recycle Masimo sensors or patient cables as these
processes may damage the electrical components, potentially leading to patient harm.
• To prevent damage, do not soak or immerse the sensor in any liquid solution.
• Do not attempt to sterilize by irradiation, steam, autoclave or ethylene oxide as it will damage the sensor.
• Do not modify or alter the sensor in any way. Alteration or modification may affect performance and/or accuracy.
D I R E C T I O N S F O R U S E
LATEX
Not made with natural rubber latex
PCX-2108A
02/13
3
en
Non-sterile
9836D-eIFU-0421