Masimo RD SET Adapter Cable Operator's Manual

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RD SET™

Adapter Cable Series

Images 2

English 3-5

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RD SET™

Adapter Cable Series

Fig. 1

Fig. 2

Fig. 4

Fig. 5 Fig. 6

Fig. 3

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RD SET™

Adapter Cable Series

DIRECTIONS FOR USE

Reusable

LATEX

Not made with natural rubber latex Non-Sterile

INDICATIONS

The RD SET™ Adapter 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.

DESCRIPTION

The RD SET Adapter cables allow Masimo RD SET sensors to be used on PC or M-LNC and RC patient cables on Masimo® SET® or Masimo rainbow® SET devices.

RD SET Adapter Cable Series consist of the following:

• RD to PC Adapter Cable

• RD to M-LNC Adapter Cable

The RD SET Adapter Cable Series have been veried using Masimo SET or Masimo rainbow SET technology. WARNING: Masimo sensors and cables are designed for use with devices containing Masimo rainbow SET oximetry or

licensed to use Masimo sensors.

WARNINGS

• 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 specic 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.

INSTRUCTIONS

Attaching the RD SET Adapter Cable to a Patient Cable

to PC Adapter Cable

1. Refer to Fig. 1. Orient the connecting tab so that the “shiny” contacts are facing up and mate to the patient cable.

2. Insert the connector into the patient cable connector until there is a tactile or audible click of connection.

3. Gently tug on the connectors to ensure a positive contact.

to M-LNC Adapter Cable

1. Refer to Fig. 2. Properly orient and insert the connector completely into the patient cable connector.

2. Refer to Fig. 3. Completely close the protective latch.

B) Disconnecting the RD SET Adapter Cable from a Patient Cable

RD to PC Adapter Cable

Refer to Fig. 4.

2. Press firmly on the buttons and pull to remove.

to a M-LNC Adapter Cable

1. Refer to Fig. 5. Lift the protective latch to gain access to the connector.

2. Refer to Fig. 6. Pull firmly on the connector to remove from the patient cable. To avoid damage, pull on the connector, not the cable.

Place thumb and index finger on the buttons on either side of the connector.

CLEANING

1. Remove the sensor from the patient and disconnect it from the adapter 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 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.

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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% non-condensing

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 instrument device or system, has been modied, or has been disassembled or reassembled. This warranty does not extend to sensors or 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 PPRODUCTS LIABILITY LAW, CANNOT LEGALLY BE PRECLUDED BY CONTRACT.

NO IMPLIED LICENSE

Purchase or possession of this RD SET Adapter Cable does not carry any express or implied license to use this RD SET Adapter Cable with any device that is not an authorized device or separately authorized to use RD SET Adapter 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.

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

-40 C

+70 C

5%-95% RH

SYMBOL DEFINITION SYMBOL DEFINITION

(blue background)

Consult Instructions for Use

Follow Instructions for Use

Manufacturer

Date of Manufacture Masimo reference number

Use By YYY Y-MM Body weight

Do not discard

Non-Sterile

LATEX

Rx Only

EC REP

Patents: http://www.masimo.com/patents.htm Masimo, SET, , and rainbow are federally registered trademarks of Masimo Corporation. RD SET and rainbow SET are trademarks of Masimo Corporation. Printed in USA.

Not made with natural rubber latex Storage Humidity Limitation

Federal law (USA) restricts this device to sale by or on the order of a physician

Mark of Conformity to European Medical Device Directive 93/42/EEC

Authorized representative in the European community Do not use if package is damaged

Light Emitting Diode (LED) LED emits light when current ows through

LOT

REF

Separate collection for electrical and electronic equipment (WEEE).

Lot code

Catalogue number (model number)

Greater than

Less than

Storage Temperature Limitation

Keep Dry

Instructions/Directions for Use/Manuals are available in electronic format @ http://www.Masimo.com/TechDocs

Note: eIFU is not available for CE mark countries.

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Manufacturer:

Masimo Corporation 40 Parker Irvine, CA 92618 USA

www.masimo.com

EU Authorized Representative for Masimo Corporation:

EC REP

MDSS GmbH Schigraben 41 D-30175 Hannover, Germany

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