www.masimo.com 1 Masimo
These operating instructions provide the necessary information for proper operation of all
models of the Rad-97. There may be information provided in this manual that is not relevant
for your system. General knowledge of pulse oximetry and an understanding of the features
and functions of Rad-97 are prerequisites for its proper use. Do not operate Rad-97 without
completely reading and understanding these instructions.
Note: Cleared Use Only: The device and related accessories are cleared by the Food and Drug
Administration (FDA) and are CE Marked for noninvasive patient monitoring and may not be
used for any processes, procedures, experiments, or any other use for which the device is not
intended or cleared by the applicable regulatory authorities, or in any manner inconsistent
with the directions for use or labeling.
Notice: Purchase or possession of this device does not carry any express or implied license to
use with replacement parts which would, alone or in combination with this device, fall within
the scope of one of the relating patents.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. See
instructions for use for full prescribing information, including indications, contraindications,
warnings and precautions.
For professional use. See instructions for use for full prescribing information, including
indications, contraindications, warnings, and precautions.
Wireless Radio
Contains: FCC ID: VKF-MWM1 | Model: Rad-97 | IC: 7362A- MWM1 | IC Model: MWM1
Masimo Corporation
40 Parker
Irvine, CA 92618, USA
Tel.: 949-297-7000
Fax.: 949-297-7001
www.masimo.com
EU authorized representative for Masimo Corporation:
MDSS GmbH
Schiffgraben 41
D-30175 Hannover, Germany
3149433
MEDICAL ELECTRICAL EQUIPMENT
WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH
ANSI/AAMI ES 60601-1:2005,CAN/CSA C22.2 No. 60601-1:2008, and
applicable Particular (EN/ISO 80601-2-61:2011) and related Collateral (IEC
60601-1-8:2006) Standards for which the product has been found to comply by
Intertek.
Patents: www.masimo.com/patents.htm
®, Adaptive Probe Off Detection®, APOD®, Discrete Saturation Transform®, DST®,
FastSat®, FST®, Masimo®, Pulse CO-Oximeter®, PVi®, rainbow®, rainbow Resposable®,
RRa®, SET®, Signal Extraction Technology®, Signal IQ®, SpCO®, SpHb®, and SpMet® are
federally registered trademarks of Masimo Corporation.
Rad-97™, rainbow Acoustic Monitoring™, rainbow SET™, RAM™, Adaptive Threshold Alarm™, In
Vivo Adjustment™, ORi™, X-Cal™, Kite™, SpOC™, and RRp™ are trademarks of Masimo
Corporation. All other trademarks and registered trademarks are property of their respective
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