© 2021 Masimo Corporation
rainbow® Series Patient Cables, EMS For Pulse Oximeters with rainbow Technology
DIRECTIONS FOR USE
LATEX Not made with natural rubber latex
INDICATIONS The rainbow® Series Patient Cables, EMS has 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 rainbow Series Patient Cables, EMS are used with Masimo® rainbow and M-LNCS® Sensors. rainbow Series Patient Cables, EMS are for use only with devices containing 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 sensor and device models. Each device manufacturer is responsible for determining whether their devices are compatible with each sensor model.rainbow Series Patient Cables, EMS 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 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 patient cable 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.
CABLE AND SENSOR SELECTION NOTE:The maximum length for the sensor, cable and extension cable combination is 15 feet. Refer to the table below for correct examples:
|Length||18 inches||3 feet||6 feet|
A. Connect the rainbow patient cable, EMS 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 rainbow patient cable, EMS to the SensorsConnect the rainbow patient cable, EMS to an M-LNCS disposable sensor:
- 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.
Connect the rainbow patient cable, EMS to a rainbow disposable sensor:
- Refer to Fig. 3. Orient the sensor connector (1) to the patient cable connector (2) as shown.
- Refer to Fig. 4. Insert the sensor connector (1) completely into the patient cable connector (2) until it locks in place as shown.
Connect the rainbow patient cable, EMS to a reusable M-LNCS or a reusable rainbow sensor:
- Refer to Fig. 5. Orient sensor connector (1) to patient cable connector (2) as shown.
- Refer to Fig. 6. Insert the sensor connector (1) completely into the patient cable connector (2) until it locks in place.
C. Disconnecting the rainbow patient cable, EMS from the SensorsNOTE: Pull on the connectors only, do not pull the cables.Disconnect the M-LNCS disposable sensor:
- Refer to Fig. 2. Pull firmly on the sensor connector to remove it from the patient cable.
Disconnect the rainbow disposable sensor:
- Refer to Fig. 4. While holding the sides of cable connector, place a thumb on latch (1) and press to disconnect sensor connector from patient cable connector.
Disconnect the reusable M-LNCS or reusable rainbow sensor:
- Refer to Fig. 5. While holding the sides of patient cable connector (2), lift sensor connector cover (3) from patient cableconnector (2). Disconnect sensor connector (1) from patient cable connector (2).
- 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.
- 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.
|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% non-condensing|
rainbow series patient cables, EMS is intended for use only with devices containing Masimo SET or Masimo Rainbow SET technology and 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
Masimo 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 24 months (2 years). 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 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 ORCONSEQUENTIAL 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 this rainbow 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 rainbow 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:
|Follow instructions for use||Separate collection for electrical and electronic equipment (WEEE).||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||Catalog number (model number)||Authorized Representative in the European community|
|Date of manufacture YYYYMM-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
|Fragile, handle with care||Greater than||Less than|
|Non-sterile||Not made with natural
|Atmospheric pressure limitation|
|Medical device||Unique device identifier||
Instructions/Directions for Use/Manuals are available in electronic format @http://www.Masimo.com/TechDocsNote: eIFU is not available in all countries.
Patents: http://www.masimo.com/patents.htmMasimo, rainbow SET, M-LNCS, X-Cal, SET, , and rainbow 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, Germany9877B-eIFU-0321