Masimo RD SET DCI Série Mode D'emploi page 4

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B. Attaching the sensor to the patient

1. Refer to Fig. 1a. Open the sensor by pressing on hinge tabs. Place the selected digit over the sensor window of the RD SET DCI or DCI-P. The fleshiest part of

the digit should be covering the detector window in the lower half of the sensor. The top half of the sensor is identified by the cable. On a finger site, the tip of

the finger should touch the raised digit stop inside the sensor. If the fingernail is long, it may extend over and pass the finger stop.

2. Refer to Fig. 1b. The hinged tabs of the sensor should open to evenly distribute the grip of the sensor along the length of the finger. Check position of sensor

to verify correct positioning. Complete coverage of the detector window is needed to ensure accurate data.

3. Refer to Fig. 1c. Orient the sensor so that the cable will be running towards the top of the patient's hand.

NOTE: With smaller digits, in order to completely cover the detector window, it may be necessary to use a lower weight range sensor. The sensor is not intended for use on the

thumb or across a child's hand or foot.

C. Attaching the Sensor to the Patient Cable

1. Refer to Fig. 2a. Properly orient the sensor connector and insert the sensor connector completely into the patient cable connector.

2. Refer to Fig. 2b. Close the protective latch completely.

D. Disconnecting the Sensor from the Patient Cable

1. Refer to Fig. 3a. Lift up the protective latch.

2. Refer to Fig. 3b. Pull firmly on the sensor connector to remove it from the patient cable.

NOTE: To avoid damage, pull on the sensor connector, not the cable.

CLEANING

Remove the sensor from the patient and disconnect it from the patient cable.

Clean the sensor by wiping with a 70% isopropyl alcohol pad.

Allow the sensor to dry thoroughly prior to placement on a patient.

If low-level disinfection is required, use a 1:10 bleach / water solution.

Saturate a cloth or gauze pad with the cleaning solution and wipe all surfaces of the sensor and cable.

Saturate another cloth or gauze pad with sterile or distilled water and wipe all surfaces of the sensor and cable.

Dry the sensor and cable with a clean cloth or dry gauze pad.

CAUTIONS:

Do not use undiluted bleach (5% - 5.25% sodium hypochlorite) or any cleaning solution other than those recommended here because permanent damage to the sensor

•

may occur.

Do not immerse the sensor or connector in any liquid solution.

•

Do not sterilize by irradiation, steam, autoclave or ethylene oxide.

•

SPECIFICATIONS

When used with Masimo SET pulse oximetry monitors or with licensed Masimo SET pulse oximetry modules RD SET DCI® and DCI-P reusable sensors have the following

specifications:

Used with:

Sensor

Body Weight

+70 C

-40 C

+1060 hPa - +500 hPa

795 mmHg - 375 mmHg

Application site

NON

STERILE

SpO

Accuracy, No Motion, (70 - 100%

5%-95% RH

SpO

Accuracy, Motion

LATEX

SpO

Accuracy, Low Perfusion

95%

Pulse Rate

Accuracy, No Motion, (25 - 240 bpm)

Pulse Rate Accuracy, Motion

Title: Graphics, Sensor/Cable symbols, 03/06

Pulse Rate Accuracy, Low Perfusion

GR-14231

DRO-13914

NOTE: The A

Accuracy is calculated based upon measurement values that are statistically distributed; approximately 68% of the measured values fell within +/- the Arms

rms

value when compared to the reference device under a controlled study.

The Masimo SET Technology has been validated for no motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark pigmented skin in

induced hypoxia studies in the range of 70%-100% SpO

population.

The Masimo SET Technology has been validated for motion accuracy in human blood studies on healthy adult male and female volunteers 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

population

The Masimo SET Technology has been validated for low perfusion accuracy in bench top testing against a Biotek 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%. This variation equals plus or minus one standard deviation which encompasses 68%

of the population.

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 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%. This variation equals plus or minus one standard deviation

which encompasses 68% of the population.

COMPATIBILITY

This sensor is intended for use only with devices containing Masimo SET oximetry or pulse oximetry monitors licensed to use RD SET 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.

RD SET DCI

> 30 kg

Finger

)

3 bpm

5 bpm

3 bpm

against a laboratory co-oximeter. This variation equals plus or minus one standard deviation which encompasses 68% of the