Masimo Rad-5 User manual

signal extraction pulse oximeters
OPERATOR’S MANUAL

Signal Extraction Pulse Oximeter
OPERATOR’S MANUAL

i
The Rad-5 and Rad-5v Operating Instructions intend to provide the necessary information for proper opera-
tion of all Rad-5 and Rad-5v pulse oximeter models. There may be information provided in this manual that
is not relevant for your pulse oximetry system.
General knowledge of pulse oximetry and an understanding of the features and functions of the Rad-5 and
Rad-5v Pulse Oximeter are prerequisites for proper use.
Do not operate the Rad-5 or Rad-5v Pulse Oximeter without completely reading and understanding
these instructions.
NOTICE
Purchase or possession of this device does not carry any express or implied license to use with replace-
ment parts which would, alone or in combination with this device, fall within the scope of one of the relating
patents.
CAUTION:
FEDERAL LAW (U.S.) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A
PHYSICIAN.
For further information contact:
Masimo Corporation
40 Parker
Irvine, CA 92618
USA
Tel.: [phone]
Fax.: [phone]
www.masimo.com
EU Authorized Representative for Masimo Corporation:
MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany
Tel.: [phone]
Fax.: [phone]
MEDICAL ELECTRICAL EQUIPMENT WITH RESPECT TO ELECTRIC
SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE
WITH UL 60601-1/CAN/CSA C22.2 No. 601.1
Covered by one or more of the following U.S. Patents: RE38,492, RE38,476, 6,850,787, 6,826,419, 6,816,741,
6,699,194, 6,684,090, 6,658,276, 6,654,624, 6,650,917, 6,643,530, 6,606,511, 6,501,975, 6,463,311, 6,430,525,
6,360,114, 6,263,222, 6,236,872, 6,229,856, 6,206,830, 6,157,850, 6,067,462, 6,011,986, 6,002,952, 5,919,134,
5,823,950, 5,769,785, 5,758,644, 5,685,299, 5,632,272, 5,490,505, 5,482,036, international equivalents, or one
or more of the patents referenced at www.masimo.com/patents.htm. Other patents pending.
© 2009 Masimo Corporation. All rights reserved. Masimo, SET, , Radical, Rad-5, Signal IQ, APOD,
LNOP, LNCS, DCI and FastSat are federally registered trademarks of Masimo Corporation.
Rad-5v, TrendCom, SatShare, Discrete Saturation Transform (DST), DCIP, RED, M-LNCS and SIQ are
trademarks of Masimo Corporation.
EC REP
Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual

Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual ii
The Rad-5/5v Handheld Pulse Oximeter’s software program is designed to minimize the pos-
sibility of hazards from errors by following sound engineering design processes, Risk Analysis
and Software Validation.
■Explosion hazard. Do not use the Pulse Oximeter in the presence of flammable anes-
thetics or other flammable substance in combination with air, oxygen-enriched environ-
ments, or nitrous oxide.
■The Pulse Oximeter is NOT intended for use as an apnea monitor.
■A Pulse Oximeter should be considered an early warning device. As a trend towards
patient hypoxemia is indicated, blood samples should be analyzed by laboratory
instruments to completely understand the patient’s condition.
■Pulse rate measurement is based on the optical detection of a peripheral flow pulse
and therefore may not detect certain arrhythmias. The pulse oximeter should not be
used as a replacement or substitute for ECG based arrhythmia analysis.
■The Pulse Oximeter is to be operated by qualified personnel only. This manual, acces-
sory directions for use, all precautionary information, and specifications should be
read before use.
■Electric shock hazard. Do not open the pulse oximeter cover except to replace the
battery of the unit. Only a qualified operator may perform maintenance procedures
specifically described in this manual. Refer servicing to Masimo for repair of this
equipment.
■As with all medical equipment, carefully route patient cabling to reduce the possibility
of patient entanglement or strangulation.
■Do not place the pulse oximeter or accessories in any position that might cause it to
fall on the patient. Do not lift the pulse oximeter by the patient cable.
■Interfering Substances: Carboxyhemoglobin may erroneously increase readings. The
level of increase is approximately equal to the amount of carboxyhemoglobin present.
Dyes, or any substance containing dyes, that change usual blood pigmentation may
cause erroneous readings.
■Severe anemia may cause erroneous SpO2readings.
■Do not use the pulse oximeter or oximetry sensors during magnetic resonance imag-
ing (MRI) scanning. Induced current could potentially cause burns. The pulse oximeter
may affect the MRI image, and the MRI unit may affect the accuracy of the oximetry
measurements.
■If using pulse oximetry during full body irradiation, keep the sensor out of the irradia-
tion field. If sensor is exposed to the irradiation, the reading might be inaccurate or
the unit might read zero for the duration of the active irradiation period.
■Always remove the sensor from the patient and completely disconnect the patient
from the pulse oximeter before bathing the patient.
■Do not place the pulse oximeter where the controls can be changed by the patient.
SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES