Masimo RD SET User manual

© 2019 Masimo Corporation
RD SET™ DBI
Reusable Soft Sensors
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Performance Specications 95

29022B-eIFU-0119
RD SET™ DBI
Reusable Soft Sensors
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Fig. 1 Fig. 2

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en
RD SET™ DBI
Reusable Soft Sensors
DIRECTIONS FOR USE
Reusable
LATEX
PCX-2108A
02/13
Not made with natural rubber latex
NON
STERILE
LATEX
Title:Graphics, Sensor/Cable symbols, 03/06
GR-14231
DRO-13914
-40 C
+70 C
+1060 hPa - +500 hPa
795 mmHg - 375 mmHg
5%-95% RH
5%
95%
%
Non-sterile
Prior to using this sensor, the user should read and understand the Operator’s Manual for the monitor and this Directions for Use.
INDICATIONS
When used with Masimo SET® or Masimo rainbow® SET:
The RD SET™ DBI Reusable Soft Sensors are indicated for the continuous noninvasive monitoring and spot-checking of functional oxygen
saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2sensor) for use with adult and pediatric patients during no motion
conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
When used with Nellcor and Nellcor Compatible Pulse Oximeters or Philips FAST SpO2Technology:
RD SET DBI Reusable Soft Sensors are indicated for the continuous noninvasive monitoring and spot-checking of functional oxygen saturation of
arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2sensor) for use with patients during no motion conditions, in hospitals, hospital-
type facilities, mobile, and home environments.
CONTRAINDICATIONS
The RD SET DBI Reusable Soft Sensors are contraindicated for use on active patients or for prolonged periods of use. The sensor site must be
inspected at least every four (4) hours or sooner, and if the circulatory condition or skin integrity is compromised, the sensor should be applied
to a dierent site.
DESCRIPTION
The RD SET DBI Reusable Soft Sensors are for use only with devices containing or licensed to use Masimo SET technology. Consult individual
device manufacturer for compatibility of particular device and sensor models. Each device manufacturer is responsible for determining whether
their devices are compatible with each sensor model.
RD SET DBI sensors have been veried using Masimo rainbow SET™ technology.
RD SET DBI sensors have been veried on the Nellcor N-200 and N-395 Pulse Oximeter.
WARNING: Masimo sensors and cables are designed for use with devices containing Masimo SET® oximetry or licensed to use Masimo sensors.
WARNINGS, CAUTIONS AND NOTES
• 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 circulation, skin integrity and correct optical alignment.
• Exercise extreme caution; skin erosion, tissue ischemia, and/or pressure necrosis can be caused when the sensor is not frequently moved,
applied too tightly, or becomes too tight due to edema. Assess site as frequently as every (1) hour and move the sensor if there are signs of
loss of skin integrity and/or loss of circulation or perfusion.
• Do not use tape to secure the sensor to the site; this can restrict blood flow and cause inaccurate readings. Use of tape can cause skin
damage, and/or pressure necrosis or damage the sensor.
• Carefully route sensor and patient cable to reduce the possibility of patient entanglement or strangulation.
• Misapplied sensors or sensors that become partially dislodged may cause incorrect readings.
• Misapplications due to wrong sensor types can cause inaccurate or no readings.
• Inaccurate SpO2readings may be caused by abnormal venous pulsation or venous congestion.
• Venous congestion may cause under reading of actual arterial oxygen saturation. Therefore, assure proper venous outflow from monitored
site. Sensor should not be 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 SpO2readings (e.g. tricuspid valve regurgitation, Trendelenburg position).
• The pulsations from intra-aortic balloon support can affect the pulse rate displayed on the oximeter. Verify patient’s pulse rate against the
ECG heart rate.
• Avoid placing the sensor on any 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 sensor is exposed to the radiation, the
reading might be inaccurate or not provided for the duration of the active radiation.
• If using pulse oximetry during full body irradiation, keep the sensor out of the radiation field. If sensor is exposed to the radiation, the
reading might be inaccurate or the unit might read zero for the duration of the active radiation period.
• Do not use the sensor during MRI scanning or in a MRI environment as it may result in physical harm.
• 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.
• Inaccurate readings may be caused by EMI radiation interference.
• 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 or no readings.
• 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 SpO2readings.
• Elevated levels of Methemoglobin (MetHb) may lead to inaccurate SpO2readings.
• Elevated levels of total bilirubin may lead to inaccurate SpO2readings.

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• Inaccurate SpO2readings may be caused by severe anemia, very low arterial perfusion, or extreme motion artifact.
• Hemoglobinopathies and synthesis disorders such as thalassemias, Hb s, Hb c, sickle cell, etc. may cause inaccurate SpO2readings.
• Inaccurate SpO2readings may be caused by vasospastic disease such as Raynaud’s, and peripheral vascular disease.
• Inaccurate SpO2readings may be caused by elevated levels of dyshemoglobin, hypocapnic or hypercapnic conditions and severe
vasoconstriction orhypothermia.
• SpO2readings may be affected under very low perfusion conditions at the monitored site.
• Readings provided with a low signal confidence indicator may not be accurate.
• Do not modify or alter the sensor in any way. Alteration or modification may affect performance and/or accuracy.
• Clean the sensors prior to reuse on multiple patients.
• To prevent damage, do not soak or immerse the sensor in any liquid solution.
• Do not attempt to sterilize by irradiation, steam, autoclave or ethylene oxide as it will damage the sensor.
• Do not attempt to reprocess, recondition or recycle Masimo sensors or patient cables as these processes may damage the electrical
components, potentially leading to patient harm.
• 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.
INSTRUCTIONS
A) Site Selection
• Choose a site that is well perfused and least restricts a conscious patient’s movements.The ring finger of the non-dominant hand is preferred.
• Site should be cleaned of debris prior to sensor placement.
B) Attaching the sensor to the patient
1. Refer to Fig. 1. Hold the sensor with star and cable on top. Open the sensor by pressing on the sides of the sensor. Insert the selected digit
into the sensor.
2. Refer to Fig. 2. Orient the sensor so that the cable runs toward the top of the patient’s hand. The tip of the finger should touch the raised
digit stop inside the bottom of the sensor. If the fingernail is long, it may extend through the opening at the end of the sensor. Check the
arrangement of the sensor to verify correct positioning. Release the sides of the sensor. Complete coverage of the detector is needed to
ensure accurate data.
C) Attaching the Sensor to the Patient Cable
1. Refer to Fig. 3. Properly orient the sensor connector and insert the sensor connector completely into the patient cable connector.
2. Refer to Fig. 4. Close the protective latch cover completely.
D) Disconnecting the Sensor from the Patient Cable
1. Refer to Fig. 5. Lift up the protective cover.
2. 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.
CLEANING
To surface clean the sensor:
1. Remove the sensor from the patient and disconnect it from the patient cable.
2. Clean the sensor surface by wiping it with a 70% isopropyl alcohol pad.
3. Allow the sensor to dry prior to placement on a patient. If low-level disinfection is required, proceed to steps 4 through 7.
4. Saturate a cloth or gauze pad with one of the following solutions:
• Glutaraldehyde (such as Metrex, Metricide 28 or Cidex 2250)
• Ammonium Chlorides (such as ECOLAB, Huntington Brand, Aspeti-Wipe)
• 1:10 bleach/water solution
5. Wipe all surfaces of the sensor and cable.
6. Saturate another cloth or gauze pad with sterile or distilled water and wipe all surfaces of the sensor and cable.
7. Dry the sensor and cable by wiping all surfaces with a clean cloth or dry gauze pad.
To clean or disinfect the sensor using a soaking method:
1. Place the sensor in one of the following cleaning solutions, so that the sensor and desired length of cable are completely immersed.
• Glutaraldehyde (such as Metrex, Metricide 28 or Cidex 2250)
• Ammonium Chlorides (such as ECOLAB, Huntington Brand, Aspeti-Wipe)
• 1:10 bleach/water solution
2. Dislodge air bubbles by gently shaking the sensor and cable.
3. Soak the sensor and the cable for at least 10 minutes and not greater than 24 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 by wiping all surfaces 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 cable in any liquid solution.
• Do not sterilize by irradiation, steam, autoclave, or ethylene oxide.

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SPECIFICATIONS
The RD DBI sensors have the following specications:
RD SET DBI Sensor Masimo SET Technology Nellcor Technology
Body Weight > 30 kg > 30 kg
Application Site Middle or Ring Finger Middle or Ring Finger
SpO2Accuracy, No Motion 2%12%4
SpO2Accuracy, Low Perfusion 2%2--
Pulse Rate Accuracy, No Motion 3 bpm33 bpm4
Pulse Rate Accuracy, Low Perfusion 3 bpm3--
NOTE: Arms accuracy is a statistical calculation of the dierence between device measurements and reference measurements. Approximately two-
thirds of the device measurements fell within ± Arms of the reference measurements in a controlled study.
1The 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% SpO2against a laboratory CO-Oximeter.
2The 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%.
3The 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%.
4Not validated for Motion and Low Perfusion accuracy using Nellcor Technology.
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
ENVIRONMENTAL
Operating Temperature 41°F to 104°F (5°C to 40°C)
Storage Temperature -40°F to 158°F (-40°C to 70°C)
Relative Humidity 10% to 95% noncondensing
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 device or system, has been modied, 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.
NO IMPLIED LICENSE
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 SET DBI SENSORS.