MASIMO SET GE Patient Cables User Guide
- June 7, 2024
- MASiMO
Table of Contents
Masimo SET® GE
Patient Cables
© 2021 Masimo Corporation
Masimo SET ® GE
Patient Cables
Masimo SET® GE
Patient Cables
DIRECTIONS FOR USE
Reusable
LATEX
Not made with natural rubber latex
Non-Sterile
INDICATIONS
The 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.
DESCRIPTION
Masimo SET® GE Patient Cables are for use with Masimo® LNOP and LNCS sensors
and with GE Healthcare devices containing
Masimo 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 Cables
Attaching the Masimo SET® GE Patient Cable to the Device
- 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
- Refer to Fig. 2. Insert the sensor connector completely into the GE patient cable connector.
- Refer to Fig. 3. Completely close the protective cover.
Attaching the Masimo SET® GE Patient Cables to an LNOP Sensor
- 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.
- 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
- Refer to Fig. 4. Lift the protective cover to gain access to the sensor connector.
- 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 Sensor
1. 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.
CLEANING
Clean 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
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 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 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 LICENSE
Purchase 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 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| | Catalogue number (model number)| | Authorized representative
in the
European 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 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.htm
Masimo, SET, Masimo SET, X-Cal, , LNOP, and LNCS are federally registered
trademarks of Masimo Corporation.
GE is a trademark of General Electric Corporation.