MASIMO SET GE Patient Cables User Guide

Table of Contents

Masimo SET® GEPatient Cables

© 2021 Masimo Corporation

Masimo SET ® GEPatient Cables

Masimo SET® GEPatient Cables

DIRECTIONS FOR USE

Reusable

LATEX

Not made with natural rubber latex

 

Non-Sterile

 

INDICATIONSThe Masimo® SET® GE Patient Cables (LNOP® Patient Cable Series and LNCS® Patient Cable Series) 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.

DESCRIPTIONMasimo SET® GE Patient Cables are for use with Masimo® LNOP and LNCS sensors and with GE Healthcare devices containingMasimo SET® Technology.The Masimo SET® GE Patient Cables and Masimo sensors have been validated on devices with Masimo SET® technology.

WARNINGS, CAUTIONS, AND NOTES

  • 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.
  • Carefully route the patient cable to reduce the possibility of patient entanglement or strangulation.
  • 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.
  • Masimo sensors and cables are designed for use with devices containing Masimo SET® oximetry or licensed to use Masimo sensors.
  • 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.
  • 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.
  • Always refer to the oximeter module operator’s manual for complete instructions or additional instructions.
  • 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.
  • 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

Attaching the Masimo SET® GE Patient CablesAttaching the Masimo SET® GE Patient Cable to the Device

  1. Refer to Fig. 1. Orient the connector of the cable to mate with the patient cable connector on the device and innert.

Attaching the Masimo SET® GE Patient Cable to an LNCS Sensor

  1. Refer to Fig. 2. Insert the sensor connector completely into the GE patient cable connector.
  2. Refer to Fig. 3. Completely close the protective cover.

Attaching the Masimo SET® GE Patient Cables to an LNOP Sensor

  1. Refer to Fig. 6. 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. Refer to Fig. 7. Insert the tab of the sensor into the patient cable connector until there is a tactile or audible click of connection. 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.

Disconnecting the Masimo SET® GE Patient Cable

Disconnecting the Masimo SET® GE Patient Cable from a LNCS Sensor

  1. Refer to Fig. 4. Lift the protective cover to gain access to the sensor connector.
  2. Refer to Fig. 5. Pull firmly on the sensor connector to remove from the patient cable.Disconnecting the Masimo SET® GE Patient Cable from the LNOP Sensor1. Refer to Fig. 8. Place thumb and index finger on the buttons on either side of the patient cable connector.2. Press firmly on the buttons and pull to remove the sensor.

CLEANINGClean the Masimo SET® GE patient cable by wiping it with a 70% isopropyl alcohol pad and allowing to dry thoroughly.

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 5% to 95% non-condensing

COMPATIBILITY

Masimo SET® GE Patient Cables are 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/or cable model. For Compatibility Information Reference:www.masimo.com

WARRANTYMasimo 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 LIMITATIONANY 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 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 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 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 this Masimo SET® GE 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 SL 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 the product, please notify the competent authority in your country and the manufacturer.The following symbols may appear on the product or product labeling:

SYMBOL DEFINITION SYMBOL DEFINITION SYMBOL DEFINITION
Follow instructions for use Separate collection for electrical andelectronic equipment (WEEE). Caution: Federal law (USA) restrictsthis device to sale by or on theorder of a physician
Consult instructions for use Lot code Mark of conformity to EuropeanMedical Device Directive 93/42/EEC
Manufacturer Catalogue number (model number) Authorized representative in theEuropean community
Date of manufacture YYYYMM-DD Masimo reference number Body weight
Caution Storage humidity limitation Storage temperature range
Do not discard Do not use if package is damagedand consult instructions for use Keep dry
Fragile, handle with care Greater than Less than
 Non-sterile Not made with natural rubber latex Atmospheric pressure limitation
Medical device Unique device identifier Instructions/Directions for Use/Manuals are available in electronicformat @ http://www.Masimo.com/TechDocsNote: eIFU is not available in all countries.
Importer Distributor

Patents: http://www.masimo.com/patents.htmMasimo, SET, Masimo SET, X-Cal, , LNOP, and LNCS are federally registered trademarks of Masimo Corporation.GE is a trademark of General Electric Corporation.

References

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