Masimo Rad-87 User manual

OPERATOR’S MANUAL
Rad-87™
Pulse CO-Oximeter

OPERATOR’S MANUAL
Rad-87™
Pulse CO-Oximeter

Rad-87 Pulse CO-Oximeter Operator’s Manual i
The Rad-87 Operating Instructions provide the necessary information for proper operation of all models of the
Rad-87 device. General knowledge of pulse CO-Oximetry and an understanding of the features and functions of the
Rad-87 are a prerequisite for its proper use. Do not operate the Rad-87 without completely reading and understanding
the instructions in this manual.
NOTICE:
Purchase or possession of this device does not carry any express or implied license to use this device with
replacement parts which would, alone or in combination with this device, fall within the scope of one of the patents
relating to this device.
CAUTION:
Federal law (U.S.) restricts this device to sale by or on the order of a physician.
Masimo Corporation
40 Parker
Irvine, CA 92618
USA
Tel.: [phone]
Fax.: [phone]
www.masimo.com
EU Authorized Representative for Masimo Corporation:
EC REP
MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany
Tel.: [phone]
Fax.: [phone]
3149433
CONFORMS TO UL STD 60601-1, UL STD 763
UL STD 963 AND NSF STD 12;
CERTIFIED TO CAN/CSA STD C22.2 NO. 601.1
Covered by one or more of the following U.S. Patents: RE38,492, RE38,476, 7,221,971, 7,215,986, 7,215,984,
7,186,966, 6,979,812, 6,861,639, 6,850,787, 6,826,419, 6,816,741, 6,745,060, 6,699,194, 6,684,090, 6,654,624,
6,650,917, 6,643,530, 6,606,511, 6,515,273, 6,501,975, 6,463,311, 6,430,525, 6,388,240, 6,360,114, 6,263,222,
6,236,872, 6,229,856, 6,157,850, 6,067,462, 6,011,986, 6,002,952, 5,919,134, 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.
© 2008 Masimo Corporation. Masimo, Discrete Saturation Transform, DST, DCI, Signal Extraction Technology, SET,
Radical, , Signal IQ, SIQ, FastSat, LNOP and LNCS are federally registered trademarks of Masimo Corporation.
Rainbow and SpCO are federally registered trademarks of Masimo Laboratories.
Rad-87, Pleth Variability Index, PVI, Patient SafetyNet, RadNet, LNOPv and APOD are trademarks of Masimo
Corporation. Rainbow SET, SpMet, SpHb, SpOC, Pulse CO-Oximeter and Signal Extraction Pulse CO-Oximeter
are trademarks of Masimo Laboratories.

Rad-87 Pulse CO-Oximeter Operator’s Manualii
SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES
The Rad-87 Pulse CO-Oximeter is designed to minimize the possibility of hazards from errors in the software
program by following sound engineering design processes, Risk Analysis and Software Validation.
■Explosion hazard. Do not use the Rad-87 in the presence of flammable anesthetics or other flammable
substance in combination with air, oxygen-enriched environments, or nitrous oxide.
■High intensity extreme lights (including pulsating strobe lights) directed on the sensor, may not allow
the Pulse CO-Oximeter to obtain readings.
■The Rad-87 is NOT intended for use as an apnea monitor.
■The Pulse CO-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 Rad-87 is to be operated by qualified personnel only. This manual, accessory directions for use,
all precautionary information, and specifications should be read before use.
■Electric shock hazard. Do not open the Rad-87 device. 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 Rad-87 or accessories in any position that might cause it to fall on the patient. Do not
lift the Rad-87 by the power cord or any other cable.
■Interfering Substances: Dyes, or any substance containing dyes, that change usual blood pigmentation
may cause erroneous readings.
■SpO2is empirically calibrated to functional arterial oxygen saturation in healthy adult volunteers with
normal levels of carboxyhemoglobin (COHb) and methemoglobin (MetHb). A pulse oximeter can
not measure elevated levels of COHb or MetHb. Increases in either COHb or MetHb will affect the
accuracy of the SpO2measurement.
■For increased COHb: COHb levels above normal tend to increase the level of SpO2. The level
of increase is approximately equal to the amount of COHb that is present. NOTE: High levels of
COHb may occur with a seemingly normal SpO2. When elevated levels of COHb are suspected,
laboratory analysis (CO-Oximetry) of a blood sample should be performed.
NOTE: High levels of COHb may occur with a seemingly normal SpO2. When elevated levels of
COHb are suspected, laboratory analysis (CO-Oximetry) of a blood sample should be performed.
■For increased MetHb: the SpO2may be decreased by levels of MetHb of up to approximately 10%
to 15%. At higher levels of MetHb, the SpO2may tend to read in the low to mid 80s.When elevated
levels of MetHb are suspected, laboratory analysis (CO-Oximetry) of a blood sample should be
performed.
■Elevated levels of Methemoglobin (MetHb) will lead to inaccurate SpO2and SpCO
measurements.
■Elevated levels of Carboxyhemoglobin (COHb) will lead to inaccurate SpO2measurements.
■Elevated levels of Total Bilirubin may lead to inaccurate SpO2, SpMet, SpCO, SpHb and SpOC
measurements.
■Motion artifact may lead to inaccurate SpMet, SpCO, SpHb and SpOC measurements.

Rad-87 Pulse CO-Oximeter Operator’s Manual iii
■Very low arterial Oxygen Saturation (SpO2) levels may cause inaccurate SpCO and SpMet
measurements.
■Severe anemia may cause erroneous SpO2readings.
■ Hemoglobin synthesis disorders may cause erroneous SpHb readings.
■Do not use the Rad-87 or sensors during magnetic resonance imaging (MRI) scanning. Induced
current could potentially cause burns.The Rad-87 may affect the MRI image and the MRI device may
affect the accuracy of the Pulse CO-Oximetry parameters and measurements.
■If using Rad-87 during full body radiation, keep the sensor out of the radiation field. If the sensor is
exposed to the radiation, the reading might be inaccurate or the device might read zero for the duration
of the active irradiation period.
■For home use, ensure that the Rad-87’s alarm can be heard from other rooms in the house especially
when noisy appliances such as vacuum cleaners, dishwashers, clothes dryers, televisions, or radios
are operating.
■Always remove the sensor from the patient and completely disconnect the patient from the Rad-87
before bathing the patient.
■Additional information specific to Masimo sensors including information about parameter/measurement
performance during motion and low perfusion, may be found in the sensor's Directions For Use
(DFU).
■Do not place the Rad-87 where the controls can be changed by the patient.
■Do not place the Rad-87's face against a surface. This will cause the alarm to be muffled.
■Do not place the Rad-87 on electrical equipment that may affect the Pulse CO-Oximeter, preventing it
from working properly.
■Do not expose the Rad-87 to excessive moisture such as direct exposure to rain. Excessive moisture
can cause the device to perform inaccurately or fail.
■Do not place containers with liquids on or near the Rad-87. Liquids spilled on the device may cause it
to perform inaccurately or fail.
■If the Rad-87 fails any part of the setup procedures or leakage tests, remove the device from operation
until qualified service personnel have corrected the situation.
■Patient Safety - If a sensor is damaged in any way, discontinue use immediately.
■Disposal of product - Comply with local laws in the disposal of the device and/or its accessories.
■The Rad-87 can be used during defibrillation, but the readings may be inaccurate for up to 20
seconds.
■This equipment has been tested and found to comply with the limits for medical devices to the
EN 60601-1-2: 2002, Medical Device Directive 93/42/EEC and Class B digital device, Part 15,
FCC Rules/USA. These limits are designed to provide reasonable protection against harmful
interference in a typical medical installation.
SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES (CONTINUED)