Operator's Manual

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-MWM2 | Model: Rad-97 | IC: 7362A-MWM2
Masimo Corporation
52 Discovery
Irvine, CA 92618, USA
Tel.: [phone]
Fax.: [phone]
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 IEC 80601-2-30:2013) 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®, Kite®, Masimo®, NomoLine®, Pulse CO-Oximeter®, PVi®, rainbow®,
rainbow Acoustic Monitoring®, rainbow Resposable®, RAM®, RRa®, RRp®, SET®, Signal
Extraction Technology®, Signal IQ®, SpCO®, SpHb®, and SpMet®, and X-Cal® are federally
registered trademarks of Masimo Corporation.