Masimo Rad-G YI Manual De Instrucciones página 6

3. Soak the sensor and the cable for at least 10 minutes and not greater than 2 hours. Do not immerse the connector.
4. Remove from cleaning solution.
5. Place the sensor and the cable in room temperature sterile or distilled water for 10 minutes. Do not immerse the connector.
6. Remove from the water.
7. Dry the sensor and cable with a clean cloth or dry gauze pad.
CAUTION:
• Do not use undiluted bleach (5%–5.25% sodium hypochlorite) or any cleaning solution other than those recommended herein
because permanent damage to the sensor could occur.
• Do not immerse the connector on the YI cable in any liquid solution.
• Do not sterilize by irradiation, steam, autoclave, or ethylene oxide.
• Using excessive force when removing the attachment wrap may damage the sensor.
SPECIFICATIONS
When used with Masimo SET
the YI sensors have the following specifications:
Rad-G YI Sensor:
Body Weight
Application Site
SpO Accuracy, No Motion
1
2
SpO Accuracy, Motion
2
2
SpO Accuracy, Low Perfusion
2
Pulse Rate Accuracy, No Motion
Pulse Rate Accuracy, Motion
Pulse Rate Accuracy, Low Perfusion
NOTE: A
accuracy is a statistical calculation of the difference between device measurements and reference measurements.
rms
Approximately two-thirds of the device measurements fell within ± A
The Masimo SET technology has been validated for no motion accuracy in human blood studies on healthy adult male and female volunteers
1
with light to dark pigmented skin in induced hypoxia studies in the range of 70–100% SpO
The Masimo SET technology has been validated for motion accuracy in human blood studies on healthy adult male and female volunteers
2
with light to dark pigmented skin in induced hypoxia studies while performing rubbing and tapping motions, at 2 to 4 Hz at an amplitude of
1 to 2 cm and a non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70–100%
SpO against a laboratory CO-Oximeter.
2
The Masimo SET technology has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and
3
Masimo's simulator with signal strengths of greater than 0.02% and transmission of greater than 5% for saturations ranging from 70% to
100%.
The Masimo SET technology has been validated for pulse rate accuracy for the range of 25–240 bpm in bench top testing against a Biotek
4
Index 2 simulator and Masimo's simulator with signal strengths of greater than 0.02% and transmission of greater than 5% for saturations
ranging from 70% to 100%.
ENVIRONMENTAL
Storage/Transport Temperature
Storage Humidity
Operating Temperature
Operating Humidity
COMPATIBILITY
This sensor is intended for use only with devices containing Masimo SET oximetry or pulse oximetry monitors licensed to
use Rad-G YI 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.
For Compatibility Information Reference: www.Masimo.com
WARRANTY
Masimo warrants to the initial buyer only that these products, 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 device 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.
pulse oximetry monitors, or with licensed Masimo SET pulse oximetry modules and patient cables,
®
3
4
4
4
-40°C to +70°C, ambient humidity
10% to 95% relative humidity (non-condensing)
+5°C to +40°C, ambient humidity
10% to 95% relative humidity (non-condensing)
Adults / Pediatrics / Infants
> 3 kg
Finger, Hand, Thumb, Toe, Foot
2%
3%
2%
3 bpm
5 bpm
3 bpm
of the reference measurements in a controlled study.
rms
6
Neonates
1–3 kg
Foot, Hand
3 bpm
5 bpm
3 bpm
against a laboratory CO-Oximeter.
2
3%
3%
3%
9987E-eIFU-1221