MASiMO 4071 RD rainbow SET Series User Guide

Table of Contents

RD rainbow SET® SeriesPatient Cables

DIRECTIONS FOR USE

ReusableNot made with natural rubber latexNon-Sterile

INDICATIONS

The RD rainbow SET® Series patient cables have the same indications for use as the applicable sensors. Please see the compatible sensor’s directions for use for indications for use and prescribed information.DESCRIPTIONThe RD rainbow SET Series patient cables are used with RD SET® Series sensors.RD rainbow SET Series patient cables are for use only with devices containing Masimo® SET® or Masimo rainbow SET® technology Version 7.1 or higher or licensed to use rainbow® compatible sensors. Consult individual oximetry system manufacturers for compatibility of particular devices and sensor models. Each device manufacturer is responsible for determining whether their devices are compatible with each sensor model.RD rainbow SET Series patient cables have been verified using Masimo Rainbow SET technology.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

Always refer to the oximeter module operator’s manual for complete instructions or additional instructions.
Ensure the cable is physically intact, with no broken or frayed wires or damaged parts. Visually inspect the cable and discard if cracks or discoloration are found.
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.
Carefully route the patient cable to reduce the possibility of patient entanglement or strangulation.
Failure to properly connect the sensor or the oximeter module to the cable may result in intermittent readings, inaccurate results, or no reading.
To avoid damage to the cable, always hold it by the connector rather than the cable when connecting or disconnecting either end.
To prevent damage, do not soak or immerse the sensor or cable in any liquid solution. Do not attempt to sterilize the cable or 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 cable when a replace cable 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 cable is provided with X-Cal® technology to minimize the risk of inaccurate readings and unanticipated loss of patient monitoring. The cable will provide up to 17,520 hours of patient monitoring time. Replace the cable when the patient monitoring time is exhausted. Some legacy monitoring devices do not distinguish between the cable and the sensor. In these devices, a replacement sensor or similar message could pertain either to the sensor or the cable.

INSTRUCTIONS

A) Connect the RD rainbow SET Series patient cable to the Device

Connect the device connector of the patient cable to the mating connector of the device.
Ensure the patient cable connector is fully engaged with the device. A tactile or audible click of connection should be heard.

B) Connect the RD rainbow SET Series patient cable connector to an RD SET disposable sensor connector

Refer to Fig. 1. Orient the sensor connector to the patient cable connector as shown.
Refer to Fig. 2. Insert the sensor connector completely into the patient cable connector until it locks in place as shown.

C) Connect the RD rainbow SET Series patient cable connector to the RD SET reusable sensor connector

Refer to Fig 3. Orient the sensor connector to the patient cable connector, as shown.
Refer to Fig. 4. Insert the sensor connector completely into the patient cable connector. Close the sensor connector cover over the patient cable connector until it locks in place.

D) Disconnect the RD rainbow SET Series patient cable connector from the RD SET disposable sensor connector

Refer to Fig 5. Pull firmly on the sensor connector to remove it from the patient cable.

E) Disconnect the RD rainbow SET Series patient cable connector from the RD SET reusable sensor connector

Refer to Fig. 6. While holding the sides of the patient cable connector, lift the sensor connector cover from the patient cable connector.
Refer to Fig. 7. Pull firmly on the sensor connector to remove it from the patient cable.

CLEANING

Remove the sensor from the patient and disconnect it from the patient cable.
Clean the surface of the cable by wiping it with a 70% isopropyl alcohol pad.
Wipe all surfaces of the cable.
Saturate another cloth or gauze pad with sterile or distilled water and wipe all surfaces of the cable.
Dry the cable by wiping all surfaces with a clean cloth or dry gauze pad.

CAUTION

Do not immerse the connector on the cable in any liquid solution.
Do not sterilize by irradiation, steam, autoclave, or ethylene oxide.
Do not clean with chemicals not approved above.

ENVIRONMENTALOperating 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% noncondensingWARRANTYMasimo 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 BUYERS. MASIMO EXPRESSLY DISCLAIMS ALL OTHER ORAL, EXPRESS, OR IMPLIED WARRANTIES, INCLUDING WITHOUT LIMITATION ANY WARRANTIES 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 EXCLUSIONSThis 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 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 LICENSEPurchase or possession of these patient cables does not carry any express or implied license to use these cables with any device that is not an authorized device or separately authorized to use RD rainbow SET Patient Cable.SOFTWARE REQUIREMENTRD rainbow SET series patient cables are compatible with software MX V7.1.1.4 and higher.COMPATIBILITYRD rainbow SET series patient cables are intended for use only with devices containing Masimo SET technology and with compatible sensors. Consult individual oximetry system manufacturers for compatibility of particular devices and sensor models. Each device manufacturer is responsible for determining whether their devices are compatible with each sensor and cable model. Use of this cable with other devices may result in no or improper performance. For Compatibility Information Reference: www.Masimo.com

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.If you encounter any serious incident with the product, please notify the competent authority in your country and the manufacturer. The following symbols may appear on the product or product labeling: