Masimo Red DCI Manual Del Usuario página 4

Adult and Pediatric Reusable SpO2 Sensors
WARNINGS
• The site must checked at least every four (4) hours to ensure proper adhesion, skin integrity and proper alignment.
• Exercise extreme caution with poorly perfused patients; skin erosion and pressure necrosis can be caused when the sensor is not frequently
moved. Assess site at least every two (2) hours with poorly perfused patients.
• During low perfusion, the sensor site needs to be assessed frequently for signs of tissue ischemia, which can lead to pressure necrosis.
• With very low perfusion at the monitored site, the readings may read lower than core arterial oxygen saturation.
• Misapplied sensors or sensors that become partially dislodged may cause either over or under reading of actual arterial oxygen saturation.
• Do not use tape to secure the sensor to the site; this can restrict blood flow and cause inaccurate readings. Use of additional tape can cause
skin damage or damage the sensor.
• The sensor should be free of visible defects. Never use a damaged sensor or one with exposed electrical circuitry.
• Do not attempt to reprocess, recondition or recycle Masimo sensors or patient cables as these processes may damage the electrical compo-
nents, potentially leading to patient harm.
• To prevent damage, do not soak or immerse the sensor in any liquid solution. Do not attempt to sterilize.
• Carefully route cable and patient cable to reduce the possibility of patient entanglement or strangulation.
• Intravascular dyes or externally applied coloring (such as nail polish) may lead to inaccurate SpO2 measurements.
• Elevated levels of Carboxyhemoglobin (COHb) may lead to inaccurate SpO2 measurements.
• Elevated levels of Methemoglobin (MetHb) will lead to inaccurate SpO2 measurements.
• Failure to apply the sensor properly may cause incorrect measurements.
• Do not use the sensor during MRI scanning.
• Avoid placing the sensor on any extremity with an arterial catheter or blood pressure cuff.
• The pulsations from intra-aortic balloon support can be additive to the pulse rate on the oximeter pulse rate display. Verify patient's pulse
rate against the ECG heart rate.
• Venous congestion may cause under reading of actual arterial oxygen saturation. Therefore, assure proper venous outflow from monitored
site. Sensor should be not below heart level (e.g. sensor on hand of a patient in a bed with arm dangling to the floor)
• Venous pulsations may cause erroneous low readings (e.g. tricuspid value regurgitation).
• Do not modify or alter the sensor in any way. Alterations or modification may affect performance and/or accuracy.
• Caution: Replace the sensor when a replace sensor message is displayed, or when a low SIQ message is consistently displayed while monitoring
consecutive patients after completing the low SIQ troubleshooting steps identified in the monitoring device operator's manual.
• Note: 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 8,760 hours of patient monitoring time. Replace the sensor when the patient monitoring time is exhausted.
SPECIFICATIONS
When used with Pulse CO-Oximetry monitors containing Masimo Rainbow SET Technology Pulse CO-Oximetry monitors or with licensed Masimo
Rainbow SET pulse co-oximetry modules, during no motion, the accuracy of the Red reusable DCI and DCIP sensors is from 70% to 100% SpO2
is ± 2 digits (± 1 Std. Dev.) for adults. Pulse rate accuracy from 25-240 bpm is ± 3 digits, (±1 Std. Dev.).
The Saturation accuracy of Red reusable DCI and DCIP sensors during motion from 70% to 100% SpO2 is ±3 digits (±1 Std. Dev.) for adults.
The pulse rate accuracy of Red reusable DCI and DCIP sensors during motion from 25-240 bpm is ±5 digits (± 1 Std. Dev.). Red reusable DCI
and DCIP sensors have been validated on the Radical-7 Pulse CO-Oximeter.
INSTRUMENT CAPABILITY
These sensors are intended for use only with instruments containing Masimo Rainbow SET Technology or pulse oximetry monitors
licensed to use Rainbow compatible sensors. Each sensor is designed to operate correctly only on the pulse oximetry systems from
the original instrument manufacturer. Use of this sensor with other instruments may result in no or improper performance.
WARRANTY
Masimo warrants to the initial buyer only that each product it manufactures, 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.
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.
WARRANTY EXCLUSIONS
This warranty does not extend to any product that has been used in violation of the operating instructions supplied with the product, or has
been subject to misuse, neglect, accident or externally created damage. This warranty does not extend to any product that has been connected
to any unintended instrument or system, has been modified, or has been disassembled or reassembled. This warranty does not extend to sensors
or patient cables that have been reprocessed, reconditioned or recycled.
IN NO EVENT SHALL MASIMO BE LIABLE TO BUYER OR ANY OTHER PERSON FOR ANY INCIDENTAL, INDIRECT, SPECIAL OR CONSEQUENTIAL
DAMAGES (INCLUDING WITHOUT LIMITATION LOST PROFITS), EVEN IF ADVISED OF THE POSSIBILITY THEREOF. IN NO EVENT SHALL MASIMO'S
LIABILITY ARISING FROM ANY PRODUCTS SOLD TO BUYER (UNDER A CONTRACT, WARRANTY, TORT OR OTHER CLAIM) EXCEED THE AMOUNT PAID
BY BUYER FOR THE LOT OF PRODUCT(S) INVOLVED IN SUCH CLAIM. IN NO EVENT SHALL MASIMO BE LIABLE FOR ANY DAMAGES ASSOCIATED
WITH A PRODUCT THAT HAS BEEN REPROCESSED, RECONDITIONED OR RECYCLED. THE LIMITATIONS IN THIS SECTION SHALL NOT BE DEEMED
TO PRECLUDE ANY LIABILITY THAT, UNDER APPLICABLE PRODUCTS LIABILITY LAW, CANNOT LEGALLY BE PRECLUDED BY CONTRACT.
Red DCI® and DCIP™
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