MASiMO RD SET Cabled Sensor Instructions

: June 7, 2024
: MASiMO

Table of Contents

DIRECTIONS FOR USE
INSTRUCTIONS
SPECIFICATIONS
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

RD SET™ Cabled Sensor Series
Adt, Pdt, Inf, Neo, and NeoPt SpO2 Disposable Sensors

MASiMO RD SET Cabled Sensor - Sensor Series

MASiMO RD SET Cabled Sensor - Sensor Series3

MASiMO RD SET Cabled Sensor - Sensor Series5

DIRECTIONS FOR USE

| Single patient use only
---|---
| Not made with natural rubber latex
| Non-sterile

Prior to using this sensor, the user should read and understand the Operator’s Manual for the device and these Directions for Use.
INDICATIONS
The RD SET™ Cabled Sensor Series disposable sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
CONTRAINDICATIONS
The RD SET Cabled sensors are contraindicated for patients who exhibit allergic reactions to foam rubber products and/or adhesive tape.
DESCRIPTION
The RD SET Cabled sensors are for use with devices containing Masimo SET oximetry or licensed to use RD SET Cabled sensors. Consult individual device
manufacturers for compatibility of a particular device and sensor models. Each device manufacturer is responsible for determining whether its devices are compatible with each sensor model.
WARNING: Masimo sensors and cables are designed for use with devices containing Masimo SET oximetry or licensed to use Masimo sensors.

WARNINGS

All sensors and cables are designed for use with specific monitors. Verify the compatibility of the monitor, cable, and sensor before use, otherwise degraded performance and/or patient injury can result.
The sensor should be free of visible defects, discoloration and damage. If the sensor is discolored or damaged, discontinue use. Never use a damaged sensor or one with exposed electrical circuitry.
The site must be checked frequently or per clinical protocol to ensure adequate adhesion, circulation, skin integrity, and correct optical alignment.
Exercise caution with poorly perfused patients; skin erosion and pressure necrosis can be caused when the sensor is not frequently moved. Assess site as frequently as every (1) hour with poorly perfused patients and move the sensor if there are signs of tissue ischemia.
Circulation distal to the sensor site should be checked routinely.
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 reading may read lower than core arterial oxygen saturation.
Do not use tape to secure the sensor to the site; this can restrict blood flow and cause inaccurate readings. The use of additional tape can cause skin damage, and/or pressure necrosis or damage the sensor.
Sensors applied too tightly or that become tight due to edema will cause inaccurate readings and can cause pressure necrosis.
Misapplied sensors or sensors that become partially dislodged may cause incorrect measurements.
Misapplications due to wrong sensor types can cause inaccurate or no readings.
Venous congestion may cause by the reading of actual arterial oxygen saturation. Therefore, assure proper venous outflow from the monitored site. The sensor should not be below heart level (e.g. sensor on hand of a patient in a bed with an arm dangling to the floor).
Venous pulsations may cause erroneous low SpO2 readings (e.g. tricuspid valve regurgitation).
The pulsations from intra-aortic balloon support can affect the pulse rate displayed on the oximeter. Verify the patient’s pulse rate against the ECG heart rate.
Carefully route cable and patient cable to reduce the possibility of patient entanglement or strangulation.
Avoid placing the sensor on an extremity with an arterial catheter or blood pressure cuff.
If using pulse oximetry during full body irradiation, keep the sensor out of the radiation field. If the sensor is exposed to the radiation, the reading might be
inaccurate or not provided for the duration of the active radiation period.
Do not use the sensor during MRI scanning or in an MRI environment.
High ambient light sources such as surgical lights (especially those with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, and direct sunlight can interfere with the performance of the sensor.
To prevent interference from ambient light, ensure that the sensor is properly applied, and cover the sensor site with opaque material if required. Failure to take this precaution in high ambient light conditions may result in inaccurate measurements.
High levels of COHb or MetHb may occur with a seemingly normal SpO2. When elevated levels of COHb or MetHb are suspected, laboratory analysis
(CO-Oximetry) of a blood sample should be performed.
Elevated levels of Carboxyhemoglobin (COHb) may lead to inaccurate SpO2 measurements.
Elevated levels of Methemoglobin (MetHb) will lead to inaccurate SpO2 measurements.
Elevated Total Bilirubin levels may lead to inaccurate SpO2 measurements.
Abnormal fingers, Intravascular dyes such as indocyanine green or methylene blue, or externally applied coloring and texture such as nail polish, acrylic
nails, glitter, etc. may lead to inaccurate SpO2 measurements.
Inaccurate SpO2 readings may be caused by severe anemia, low arterial perfusion, or motion artifact.
To prevent damage, do not soak or immerse the sensor in any liquid solution.
Do not modify or alter the sensor in any way. Alteration or modification may affect performance and/or accuracy.
Do not attempt to reuse on multiple patients, reprocess, recondition or recycle Masimo sensors or patient cables as these processes may damage the electrical components, potentially leading to patient harm.
High oxygen concentrations may predispose a premature infant to retinopathy. Therefore, the upper alarm limit for the oxygen saturation must be carefully selected in accordance with accepted clinical standards.
Caution: Replace the sensor when a replace sensor message is displayed, or when a low SIQ message is consistently displayed 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 168 hours of patient monitoring time or up to 336 hours for sensors with a replaceable tape. After single-patient use, discard the sensor.

INSTRUCTIONS

A) Site Selection

Always choose a site that is well perfused and will completely cover the sensor’s detector window.
Site should be cleaned of debris and dry prior to sensor placement.

RD SET Cabled Adt: Adult Sensor

30 kg The preferred site is the middle or ring finger of the non-dominant hand.
RD SET Cabled Pdt: Pediatric Sensor
10-50 kg The preferred site is the middle or ring finger of the non-dominant hand.
RD SET Cabled Inf: Infant Sensor
3-10 kg The preferred site is the great toe. Alternatively, the toe next to the great toe, or the thumb can be used.
10 – 20 kg The preferred site is the middle or ring finger of the non-dominant hand. Alternatively, the toe can be used.
RD SET Cabled Neo: Neonatal/Adult Sensor
< 3 kg The preferred site is the foot. Alternatively, across the palm and back of the hand can be used.
40 kg The preferred site is the middle or ring finger of the non-dominant hand.
RD SET Cabled NeoPt: Preterm Sensors
< 1 kg The preferred site is the foot. Alternatively, across the palm and back of the hand can be used.
B) Attaching the sensor to the patient

Open the pouch and remove the sensor. Remove the backing from the sensor, if present.
Add sensor for ADULTS (> 30 kg) and Pdt sensor for PEDIATRICS (10 – 50 kg)
Refer to Fig. 1a. Orient the sensor so that the detector can be placed first. Place the tip of the finger on the dashed line with the fleshy part of the finger
covering the finger outline and detector window.
Refer to Fig. 1b. Press the adhesive wings, one at a time, onto the finger. Complete coverage of the detector window is needed to ensure accurate data.
Refer to Fig. 1c. Fold the sensor over the finger with the emitter window ( ) positioned over the fingernail. Secure the wings down, one at a time, around
the finger.
Refer to Fig. 1d. When properly applied, the emitter and detector should be vertically aligned (the black lines should align). Reposition if necessary.

Inf sensor for INFANTS (3 – 10 kg)

Refer to Fig. 2a. Direct the sensor cable so that it runs along the top of the foot. Position the detector on the fleshy pad of the great toe. Alternatively, the the toe next to the great toe or the thumb can be used (not shown).
Refer to Fig. 2b. Wrap the adhesive wrap around the toe so the emitter is positioned on the nailbed of the great toe. Complete coverage of the detector the window is needed to ensure accurate data.
Refer to Fig. 2c. Ensure that the emitter window ( ) aligns on the top of the toe directly opposite the detector. Verify correct positioning and reposition if necessary.

Neo sensor for NEONATES ( < 3 kg) and NeoPt sensor for PRETERMS (< 1 kg)

Refer to Fig. 3a. For fragile skin, the stickiness of the medical-grade adhesive can be diminished or eliminated by daubing the adhesive areas with a cotton
ball or gauze.
Refer to Fig. 3b. Direct the sensor cable toward the ankle (or wrist). Apply the sensor around the lateral aspect of the foot (or hand), aligned with the fourth
toe (or finger). Complete coverage of the detector window is needed to ensure accurate data.
Refer to Fig. 3c. Wrap the adhesive/foam wrap around the lateral aspect of the foot (or hand) and ensure that the emitter window ( ) aligns directly
opposite of the detector. Be careful to maintain proper alignment of the detector and emitter windows while attaching adhesive/foam wrap to secure the
sensor.
Refer to Fig. 3d. Verify correct positioning and reposition if necessary.

Neo sensor for ADULTS ( > 40 kg) Inf Sensor for INFANTS (10 – 20 kg)

Refer to Fig. 4a. Direct the sensor cable so that it runs along the top of the hand. Position the detector on the fleshy part of the finger. Alternatively, the
sensor may also be applied to the toe (not shown).
Refer to Fig. 4b. Wrap the adhesive wrap around the finger so the emitter window ( ) aligns on the top of the finger directly opposite the detector.
Complete coverage of the detector window is needed to ensure accurate data.
Refer to Fig. 4c. Check the sensor to verify correct positioning and reposition if necessary.

C) Attaching the Sensor to the Patient Cable

Refer to Fig. 5a. Orient the sensor’s connector tab so that the side with the “shiny” contacts is facing up. Orient the patient cable with the color bar and finger grips facing up.
Refer to Fig. 5b. Insert the sensor tab into the patient cable until there is a tactile or audible click of connection. Gently tug on the connectors to ensure a positive contact. Tape may be used to secure the cable to the patient for ease of movement.

D) Reattachment

The sensor may be reapplied to the same patient if the emitter and detector windows are clear and the adhesive still adheres to the skin.
If the adhesive no longer adheres to the skin, use a new sensor.
NOTE: When changing application sites, or reattaching sensor, first disconnect the sensor from the patient cable.

E) Disconnecting the Sensor from the Patient Cable

Refer to Fig. 6. 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.

SPECIFICATIONS

When used with Masimo SET pulse oximetry monitors, or with licensed Masimo SET pulse oximetry modules the RD SET Cabled Sensors have the following specifications:

RD SET Cabled Sensor	Adt	Pdt	Id	Neo
Body Weight	> 30 kg	10-50 kg	3-10 kg	10-20 kg
Application Site	Finger or Toe	Finger or Toe	Thumb or
Great Toe	Finger or
Toe	Hand or
Foot	Finger or

Toe
SpO2 Accuracy,
No Motion, (70 – 100%1‘5)| 2%| 2%| 2%| 2%| 3%| 2%
SpO2 Accuracy, Motion2| 3%| 3%| 3%| 3%| 3%| 3%
SpO2 Accuracy,
Low Perfusion3| 2%| 2%| 2%| 2%| 3%| 2%
Pulse Rates Accuracy,
No Motion, (25 – 240 bpm)| 3 bpm| 3 bpm| 3 bpm| 3 bpm| 3 bpm| 3 bpm
Pulse Rate Accuracy, Motion’s| 5 bpm| 5 bpm| 5 bpm| 5 bpm| 5 bpm| 5 bpm
Pulse Rate Accuracy, Low Perfusion3| 3 bpm| 3 bpm| 3 bpm| 3 bpm| 3 bpm| 3 bpm

NOTE: Arms accuracy is a statistical calculation of the difference between device measurements and reference measurements. Approximately two- thirds of the device measurements fell within ± Arms of the reference measurements in 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 darkly pigmented skin in induced hypoxia studies in the range of 70%-100% SpO2 against a laboratory co-oximeter.
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% SpO2 against a laboratory co-oximeter.
The Masimo SET Technology has been validated for low perfusion accuracy in benchtop 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%.
The Masimo SET Technology has been validated for pulse rate accuracy for the range of 25-240 bpm in benchtop 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%.
The saturation accuracy of the Neonate and Preterm sensors were validated on adult volunteers and 1% was added to account for the properties of fetal
hemoglobin.

COMPATIBILITY
This sensor is intended for use only with devices containing Masimo SET oximetry or pulse oximetry monitors licensed to use RD SET Cabled 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 THE BUYER. MASIMO EXPRESSLY DISCLAIMS ALL OTHER ORAL,
EXPRESS OR IMPLIED WARRANTIES, INCLUDING WITHOUT LIMITATION ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A 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 THE 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 THE BUYER (UNDER A CONTRACT, WARRANTY, TORT OR OTHER CLAIM) EXCEED THE AMOUNT PAID BY THE 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.

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 THE USE OF THIS PRODUCT WITH MORE THAN A SINGLE PATIENT.
AFTER SINGLE-PATIENT USE, DISCARD THE 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 RD SENSORS.
CAUTION: FEDERAL LAW (U.S.A.) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.
For professional use. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions, and adverse events.
The following symbols may appear on the product or product labeling:

MASiMO RD SET Cabled Sensor - tabile

Patents: http://www.masimo.com/patents.htm
Masimo, SET, , and X-Cal are federally registered trademarks of Masimo Corporation.
RD SET is a trademark of Masimo Corporation.

PERFORMANCE SPECIFICATIONS
The table below shows Arms (Accuracy Root Mean Square) values measured using representative Masimo Sensors with Masimo SET Oximetry Technology in a clinical study.