The Rad-8 Compact pulse 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 pulse oximeter in the presence of flammable anes-
thetics or other flammable substance in combination with air, oxygen-enriched environ-
ments, or nitrous oxide.
■
High intensity extreme lights (such as pulsating strobe lights) directed on the sensor,
may not allow the pulse oximeter to obtain vital sign readings.
■
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.
■
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 and understood 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.
■
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 and Methemoglobin may erroneously
increase readings. The level of increase is approximately equal to the amount of car-
boxyhemoglobin present. Dyes, or any substance containing dyes, that change usual
blood pigmentation may cause erroneous readings.
■
Severe anemia may cause erroneous SpO
2
readings.
■
Do not use the pulse oximeter or oximetry sensors during magnetic resonance
imaging (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 irradiation
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.
■
Do not place the pulse oximeter face against a surface. This will cause the alarm to
be muffled.
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Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual
Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual
iii
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Do not place the pulse oximeter on electrical equipment that may affect the pulse
oximeter, preventing it from working properly.
■
Do not expose the pulse oximeter to excessive moisture such as direct exposure to
rain. Excessive moisture can cause the pulse oximeter to perform inaccurately or fail.
■
Do not place containers containing liquids on or near the pulse oximeter. Liquids
spilled on the pulse oximeter may cause it to perform inaccurately or fail.
■
Failure of Operation - If the pulse oximeter fails any part of the setup procedures remove the
pulse oximeter from operation until qualified service personnel have corrected the situation.
■
Patient Safety - If a sensor or cable is damaged in any way, discontinue use
immediately.
■
Disposal of product - Comply with local laws in the disposal of the unit and/or its
accessories.
■
The pulse oximeter can be used during defibrillation, but the readings may be inac-
curate 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. These limits
are designed to provide reasonable protection against harmful interference in a typical
medical installation. This equipment generates, uses and can radiate radio frequency
energy and, if not installed and used in accordance with the instructions, may cause
harmful interference to other devices in the vicinity. However, there is no guarantee
that interference will not occur in a particular installation. If this equipment does cause
harmful interference to other devices, which can be determined by turning the equip-
ment off and on, the user is encouraged to try to correct the interference by one or
more of the following measures:
■
Reorient or relocate the receiving device.
■
Increase the separation between the equipment.
■
Consult the manufacturer for help.
■
A functional tester cannot be utilized to assess the accuracy of the pulse oximeter or
any sensors.
SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES
SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES
