MASiMO R25-12 RD RAM rainbow SET Instruction Manual

RAM® Dual Cable SeriesRD RAM rainbow SET®

DIRECTIONS FOR USE

ReusableNot made with natural rubber latexNon-SterileINDICATIONSThe RAM® Dual 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.DESCRIPTIONThe RAM Dual Cable RD rainbow SET® cables are for use with the rainbow Acoustic® Respiration Sensors )RAS( and RD SET® sensors.Refer to Fig. 1. The RAM Dual Cable RC provides two )2( types of sensor connections:

  1. An ( A connection to the Acoustic Respiration Sensor )RAS( and
  2. B( A connection to the RD SET sensor.

The RAM Dual Cable series has been verified using Masimo® SET® Technology.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.

INSTRUCTIONSNOTE: Connect the RD rainbow SET RAM Dual Cable to the rainbow Acoustic Monitoring® enabled device before connecting the sensors.A. Connecting to the rainbow Acoustic Monitoring Enabled Device1. 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 RD rainbow SET RAM Dual Cable to the Sensors Connect to a RAS sensor:

  1.  Refer to Fig. 2. Orient the arrow on the RAM Dual Cable acoustic connector )A( with the arrow on the RAS sensor )B(.
  2.  Insert the sensor connector completely into the acoustic connector until it locks in place.

Connect to an RD SET disposable sensor:

  1. Refer to Fig. 3. Orient the sensor’s connector tab with the “shiny” contacts facing up. Orient the cable with the color bar and finger grips facing up.
  2.  Refer to Fig. 4. Insert the sensor tab into the cable until there is a tactile or audible click of connection. Gently tug on the connectors to ensure positive contact.C. Disconnecting from the SensorsNOTE: Pull on the connectors only, do not pull the cables.

Disconnect from the RAS sensor:

  1.  Refer to Fig. 5. Hold the center of the RAM Dual Cable RC connector )A( and the acoustic respiration sensor connector(B.)  Pull the connectors apart to disconnect.Disconnect from the RD SET disposable sensor:1. Refer to Fig. 6. Pull firmly on the sensor connector to remove it from the patient cable.NOTE: The RAM Dual Cable RD RAM rainbow SET cable can be connected/disconnected while the device is operational.

CLEANING

  1. Remove the sensors from the patient and disconnect them 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.

COMPATIBILITY

This cable is intended for use only with rainbow Acoustic Monitoring enabled devices containing Masimo rainbow SET technology or pulse oximetry monitors licensed to use Acoustic Respiration compatible cables and sensors. Each cable is designed to operate correctly only on the pulse oximetry systems from the original device manufacturer. Use of this cable with other devices may result in no or proper performance.For Compatibility Information Reference: www.Masimo.com

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% non-condensingWARRANTYMasimo 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 BUYERS. MASIMO EXPRESSLY DISCLAIMS ALL OTHER ORAL, EXPRESS, OR IMPLIED WARRANTIES, INCLUDING WITHOUT LIMITATION ANY 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 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 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 BUYER (UNDER A CONTRACT, WARRANTY, TORT OR OTHER CLAIM) EXCEED THE AMOUNT PAID BY THE BUYER FOR THE LOT OF PRODUCT(S) INVOLVED IN THE UCH 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 PRECLUDEANY LIABILITY THAT, UNDER APPLICABLE PRODUCTS LIABILITY LAW, CANNOT LEGALLY BE PRECLUDED BY CONTRACT.NO IMPLIED LICENSEPurchase or possession of this RAM Dual Cable RD RAM rainbow SET does not carry any express or implied license to use thiscable with any device that is not an authorized device or separately authorized to use RAM Dual Cable Series 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

and electronic equipment (WEEE)

 RX ONLY Caution: Federal law (USA) restricts this

device to sale by or on the order of a physician
Consult instructions for use Lot code Mark of conformity to European Medical Device

Directive 93/42/EEC
Manufacturer Catalogue number

(model number)

 Mark of conformity to European Medical Device

Directive 93/42/EEC

 
Date of manufacture

YYYY-MM-DD

 Masimo reference number Bodyweight
Caution Storage humidity limitation Storage temperature range
Do not discard Do not use if the package is damaged

and 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 electronic format @ http://

www.Masimo.com/TechDocs

Note: eIFU is not available in all countries.
Importer Distributor

Patents: http://www.masimo.com/patents.htmMasimo, SET, , rainbow, rainbow Acoustic Monitoring, rainbow Acoustic, rainbow SET, RD SET, RD rainbow SET, X-Cal, RAM, and Ra are federally registered trademarks of Masimo Corporation.

References

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