MASiMO 4071 RD rainbow SET Series User Guide
- June 7, 2024
- MASiMO
Table of Contents
RD rainbow SET® Series
Patient Cables
© 2021 Masimo Corporation
DIRECTIONS FOR USE
Reusable
Not made with natural rubber latex
Non-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.
DESCRIPTION
The 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.
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 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 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 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 LICENSE
Purchase 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 REQUIREMENT
RD rainbow SET series patient cables are compatible with software MX V7.1.1.4
and higher.
COMPATIBILITY
RD 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:
Patents: http://www.masimo.com/patents.htm
Masimo, SET, X-Cal, RD SET, RD rainbow SET and are federally registered
trademarks of Masimo Corporation.
© 2021 Masimo Corporation
Manufacturer: Masimo Corporation
52 Discovery Irvine, CA 92618 USA
www.masimo.com
EU Authorized Representative for Masimo Corporation:
MDSS GmbH
Schiffgraben 41
D-30175 Hannover, Germany
9000G-eIFU-0121