SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES
The Radical Signal Extraction 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 anesthetics or
other flammable substance in combination with air, oxygen-enriched environments, 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, accessory
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
Handheld 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 power cord or any other cable.
■
Interfering Substances: SpO
2
is a functional calculation of arterial oxygen saturation.
Carboxyhemoglobin and Methemoglobin may erroneously increase SpO
2
readings. The level of
increase is approximately equal to the amount of carboxyhemoglobin and/or methemoglobin that
is 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
the 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.
■
For home use, ensure that the pulse oximeter’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 being operating.
■
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.
■
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.
ii
Radical Signal Extraction Pulse Oximeter Operator’s Manual
Radical Signal Extraction Pulse Oximeter Operator’s Manual
iii
■
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 or leakage tests,
remove the pulse oximeter 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 unit and/or its accessories.
■
The Pulse Oximeter Module 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. 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 equipment 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.
❚
Connect the equipment into an outlet on a circuit different from that to which the other
device(s) are connected.
❚
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 (CONTINUED)
