Masimo Red PC Series Red Patient Cables User Guide

Masimo Red PC Series Red Patient Cables
User Guide

DIRECTIONS FOR USE

Reusable          Not made with natural rubber latex         Non-Sterile

INDICATIONS

The Red PC patient cables and the Red LNC 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 Red PC patient cables are used with Masimo® LNOP® sensors and the Red LNC patient cables are used with Masimo LNCS® sensors.

The Red series of patient cables were verified using Masimo rainbow SET® Technology.

WARNING: Masimo sensors and cables are designed for use with devices containing Masimo SET® or Masimo rainbow 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 signs of deterioration 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 patient cables to reduce the possibility of patient entanglement or strangulation.
  • Failure to properly connect the sensor or the oximeter module to the cable will 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 replace sensor or similar message could pertain either to the sensor or the cable.

INSTRUCTIONS

A. Connecting the Red patient cable to the Device

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

B. Connecting the Red patient cable to the Sensors

Connect the Red PC Cable to the LNOP Sensor:

  1. Orient the connecting tab of the sensor so that the “shiny” contacts are pointed up. Mate the logo on the sensor to the logo on the patient cable.
  2. Adhesive Sensor (Fig. 1a). Reusable Sensor (Fig. 1b). Insert the tab of the sensor into the patient cable connector until there is a tactile or audible click of connection.
  3. Gently tug on the patient cable connector to ensure a positive contact. Tape may be used to secure the cable to the patient for ease of movement.

Connect the Red LNC Cable to the LNCS Sensor:

  1. Orient the connector of the sensor to mate with the connector on the extension cable.
  2. Press firmly to ensure the patient cable is fully engaged with the sensor connector (Fig. 2a) .
  3. Close the clear plastic cover to lock the sensor connector into place (Fig. 2b).
  4. Gently tug on the patient cable connector to ensure a positive contact. Do not pull on the patient cable.

C. Disconnecting the Red patient cable from the Masimo Sensor

NOTE: Pull on the connectors only, do not pull the cables.

Disonnect the Red PC patient cable from the LNOP Sensor:

  1. Place thumb and index finger on the buttons on either side of the patient cable connector .
  2. Adhesive Sensor (Fig. 3a). Reusable Sensor (Fig. 3b). Press firmly on the buttons and pull to remove the sensor.

Disonnect the Red LNC patient cable from the LNCS Sensor:

  1. Lift the clear plastic locking cover (Fig. 4a).
  2. Pull firmly on the patient cable connector and sensor connector to disconnect the sensor (Fig.  4b). Do not pull on the patient cable.

CLEANING

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

CAUTION:

  • Do not immerse the connectors 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

COMPATIBILITY

Masimo Patient Cables are for use only with devices containing Masimo SET or Masimo rainbow 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/or cable model. Use of this cable 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.

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 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 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 Red patient cable does not carry any express or implied license to use this cable with any device that is not an authorized device or separately authorized to use Red patient cables.

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 product, please notify the competent authority in your country and the manufacturer.

The following symbols may appear on the product or product labeling:

http://www.Masimo.com/TechDocs

Patents: http://www.masimo.com/patents.htm

Masimo, X-Cal, rainbow, rainbow Acoustic Monitoring, RRa and SET are federally registered trademarks of Masimo Corporation.

Manufacturer:Masimo Corporation52 DiscoveryIrvine, CA 92618USAwww.masimo.com

EU Authorized Representative for Masimo Corporation:MDSS GmbHSchiffgraben 41D-30175 Hannover, Germany

References

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