Masimo O3 Serie Instrucciones De Uso página 5

ENVIRONMENTAL
Storage Temperature
Operating temperature
Storage humidity
SPECIFICATIONS
When used with Masimo O3 Regional Oximeter, the O3® Sensors have the following performance specifications:
rSO Adhesive Sensor
2
+70 C
Body Weight
-40 C
+1060 hPa - +500 hPa
795 mmHg - 375 mmHg
Application Site
NON
STERILE
5%-95% RH
Trending Regional Oxygen Saturation (rSO LATEX
Accuracy (RMS)*
95%
%
Absolute Regional Oxygen Saturation (rSO
Accuracy(RMS)**
5%
*Note: Arms accuracy is a statistical calculation of the difference between device measurements and reference measurements.
Approximately two-thirds of the device measurements fell between +/- Arms of the reference measurements in a controlled study.
**Absolute rSO accuracy (RMS) was determined by testing on healthy adult volunteers with light to dark pigmentation in the range of
2
45% 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.
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 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.
NO IMPLIED LICENSE
This single-patient sensor is licensed to you under the patents owned by Masimo for single-patient use only. By acceptance or
use of this product, you acknowledge and agree that no license is granted for use of this product with more than a single patient.
After single patient use, discard sensor.
Purchase or possession of this sensor confers no express or implied license to use the sensor with any device which is not
separately authorized to use O3 Sensors.
-40 C to +60 C, (-40°F to 140°F), ambient humidity
+5 C to +40 C, (41°F to 104°F ), ambient humidity
+30 to +60 C, (86˚F to 140˚F), 15 to 95% humidity
)
2
)
2
O3 Sensor
Adult
≥ 40 kg ≥ 5 kg and < 40 kg
Forehead
3%
4%
5
Pediatric
Forehead Gut (optional), and
Kidney (optional)
3%
5%
Neonatal
< 10 kg
Forehead,
3%
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