Masimo Rad-G Directions For Use

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9399E-eIFU-0820
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The Masimo SET Technology has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimo’s simulator
with signal strengths of greater than 0.02% and transmission of greater than 5% for saturations ranging from 70% to 100%.
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The Masimo SET Technology has been validated for pulse rate accuracy for the range of 25-240 bpm in bench top testing against aBiotek Index 2 simulator
and Masimo’s simulator with signal strengths of greater than 0.02% and transmission of greater than 5% for saturations ranging from 70% to 100%.
COMPATIBILITY
This sensor is intended for use only with Rad-G devices containing Masimo SET technology. Each sensor is designed to operate correctly only on the
pulse oximetry systems from the original device manufacturer. Use of this sensor with other devices may result in no or improper performance.
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 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 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 PRODUCTS LIABILITY LAW, CANNOT LEGALLY BE PRECLUDED BY CONTRACT.
NO IMPLIED LICENSE
Purchase or possession of this sensor confers no express or implied license to use the sensor with any device which is not separately authorized to use
Masimo sensors.
For professional use. See instructions for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.
If you encounter any serious incident with 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 YYYY-MM-DD Masimo reference number Body weight
Use-by YYYY-MM-DD Caution Storage temperature range
Do not discard Greater than Keep dry
Non-Sterile Less than
Do not use if package is damaged and
consult instructions for use
LATEX
PCX-2108A
02/13
Not made with natural rubber latex Storage humidity limitation Atmospheric pressure limitation
Fragile, handle with care
Medical device
Unique device identier
X
Light Emitting Diode(LED)
LED emits light when current ows through
Instructions/Directions for Use/Manuals are available in electronic format @
http://www.Masimo.com/TechDocs
Note: eIFU is not available in all countries.
Patents: http://www.masimo.com/patents.htm.
Masimo, SET, , Rad, Pulse CO-Oximeter, X-Cal and rainbow are federally registered trademarks of Masimo Corporation.
Rad-G is a trademark of Masimo Corporation.

Masimo Rad-G Specifications

General

Type	Handheld Pulse Oximeter
Ingress Protection	IP22
Operating Temperature	5°C to 40°C
Storage Temperature	-20°C to 60°C
SpO2 Range	0% to 100%
Pulse Rate Range	25 – 240 bpm
Battery Type	Rechargeable Lithium-ion
Connectivity	Bluetooth
Perfusion Index Range	0.02% to 20%
PVI Range	0% - 100%
Humidity	10% to 95% (non-condensing)