Masimo O3 Instrucciones De Uso página 3

• This O3 Sensor is for single patient use only - do not clean.
• If using the O3 Sensor during full body irradiation, keep the sensor out of the radiation field.
• Disposal of product – Comply with local laws in the disposal of the instrument and/or its accessories.
• rSO readings represent a small volume of tissue beneath the O3 Sensor site and may not reflect oxygenation elsewhere.
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• Do not attempt to reprocess, recondition or recycle any Masimo sensors or patient cables as these processes may damage the electrical
components, potentially leading to patient harm.
• Do not expose the Sensor to excessive humidity. It should be used and stored in a cool, dry place.
• Replace the sensor when a replace sensor or equivalent message is displayed consistently. Consult monitoring device operator's manual for
more information.
NOTES
• The sensor is provided with X-Cal® technology to minimize the risk of inaccurate readings and unanticipated loss of patient monitoring. The
sensor will provide up to 72 hours of patient monitoring time. After single-patient use, discard sensor.
• The value of data from the system has not been demonstrated in specific disease states, under conditions of hemoglobinopathies or clinical
conditions that may affect blood volume, or under hypocapnic and hypercapnic conditions.
• If the desired tissues cannot be palpated or visualized, it is recommended to use a secondary method of confirmation, such as ultrasound
or X-ray.
• The O3 Sensor duration of use is dependent on the condition of the sensor site and patient's skin integrity and sensor adhesion quality.
The O3 Sensor has been biocompatibility tested for the intended continuous use up to 72 hours.
INSTRUCTIONS
Applying the Sensor on the Patient
• Ensure that the patient's skin is clean, dry, and free of debris and oil.
• The preferred measuring site is the forehead, above the eyebrows.
• Remove the sensor from the release liner.
• Apply the sensor to the forehead. Sensor should be just above each of the eyebrows.
• The cable portion should be routed such that it does not apply pressure to the skin and is not pulling on the sensor.
Connecting the Sensor to the O3 Module
• Up to two Sensors can be connected to the O3 Module simultaneously.
• Align the connector at the end of the Sensor's cable portion to the sensor connection on the Module.
• Insert the connector securely into the sensor connection.
• The Sensor Site screen will display on Root each time a new Sensor is connected to the Module.
Disconnecting the Sensor from the O3 Module
• Gently pull the Sensor connector out of the sensor connection on the Module.
Sensor Removal
Gently peel off the Sensor from the application site. If the Sensor is difficult to remove, use alcohol to assist in removal.
Note: The Sensor is not reusable. Dispose of the sensor according to local laws.
ENVIRONMENTAL
Operating Temperature
Storage Temperature
Storage Humidity
SPECIFICATIONS
When used with Masimo O3 Regional Oximeter, the O3® pediatric sensor has the following performance specifications:
rSO Adhesive Sensor
2
Body Weight
Application Site
Trending Regional Oxygen Saturation (rSO
Absolute Regional Oxygen Saturation (rSO
Note: A
accuracy is a statistical calculation of the difference between device measurements and reference measurements. Approximately two-
rms
thirds of the device measurements fell between +/- A
Absolute rSO accuracy (A
1
2
rms
to 85% SavO against 30% arterial and 70% jugular venous blood oxygen saturations, measured with a laboratory CO-Oximeter.
2
COMPATIBILITY
This sensor is intended for use only with devices containing Masimo SET oximetry or pulse oximetry monitors licensed to use O3 Sensors.
Each sensor is designed to operate correctly only on the pulse oximetry systems from the original device manufacturer. Use of this sensor
with other devices may result in no or improper performance.
WARRANTY
Masimo warrants to the initial buyer only that this product, when used in accordance with the directions provided with the Products by Masimo, will
be free of defects in materials and workmanship for a period of six (6) months.
Single use products are warranted for single patient use only.
The foregoing is the sole and exclusive warranty applicable to the products sold by Masimo to buyer. Masimo expressly disclaims all other oral, express
or implied warranties, including without limitation any warranties of merchantability or fitness for particular purpose. Masimo's sole obligation and
buyer's exclusive remedy for breach of any warranty shall be, at Masimo's option, to repair or replace the product.
41°F to 104°F (5°C to 40°C)
-40°F to 140°F (-40°C to 60°C)
15% to 90% humidity, 86˚F to 140˚F (30˚C to 60˚C)
O3® Sensor
) Accuracy (A
2
) Accuracy (A
2
of the reference measurements in a controlled study.
rms
) was determined by testing on pediatric patients ≥5 kg, <40 kg with varying skin pigmentation in the range of 45%
Adult
≥ 40 kg
Forehead
) 3%
rms
)
4%
rms
3
Pediatric
≥ 5 kg and < 40 kg
Forehead
3%
5%
1
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