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ii Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual iii

SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES

The Radical-7 Signal Extraction Pulse CO-Oximeter is designed to minimize the pos-

sibility 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 CO-Oximeter in the presence of ﬂ am-

mable anesthetics or other ﬂ ammable 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 CO-Oximeter to obtain vital sign readings.

■ The Pulse CO-Oximeter 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.

■ The Pulse CO-Oximeter is to be operated by qualiﬁ ed personnel only. This manu-

al, accessory directions for use, all precautionary information, and speciﬁ cations

should be read before use.

■ Electric shock hazard. Do not open the Pulse CO-Oximeter cover except to

replace the battery of the Handheld unit. Only a qualiﬁ ed operator may perform

maintenance procedures speciﬁ cally 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 pos-

sibility of patient entanglement or strangulation.

■ Do not place the Pulse CO-Oximeter or accessories in any position that might

cause it to fall on the patient. Do not lift the Pulse CO-Oximeter by the power

cord or any other cable.

■ Interfering Substances: SpO

is a functional calculation of arterial oxygen satura-

tion. Carboxyhemoglobin and Methemoglobin may erroneously increase SpO

readings. The level of increase is approximately equal to the amount of car-

boxyhemoglobin and/or methemoglobin that is present. Dyes, or any substance

containing dyes, that change usual blood pigmentation may cause erroneous

readings.

■ Elevated levels of Methemoglobin (MetHb) will lead to inaccurate SpO

measure-

ments.

■ Elevated levels of Carboxyhemoglobin (COHb) will lead to inaccurate SpO

mea-

surements.

■ Severe anemia may cause erroneous SpO

readings.

■ Do not use the Pulse CO-Oximeter or oximetry sensors during magnetic reso-

nance imaging (MRI) scanning. Induced current could potentially cause burns.

The Pulse CO-Oximeter may affect the MRI image, and the MRI unit may affect

the accuracy of the oximetry measurements.

■ If using Pulse CO-Oximetry during full body irradiation, keep the sensor out of

the irradiation ﬁ eld. 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.

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■ For home use, ensure that the Pulse CO-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 operating.

■ Always remove the sensor from the patient and completely disconnect the patient

from the Pulse CO-Oximeter before bathing the patient.

■ Do not place the Pulse CO-Oximeter where the controls can be changed by the

patient.

■ Do not place the Pulse CO-Oximeter face against a surface. This will cause the

alarm to be mufﬂ ed.

■ Do not place the Pulse CO-Oximeter on electrical equipment that may affect the

Pulse CO-Oximeter, preventing it from working properly.

■ Do not expose the Pulse CO-Oximeter to excessive moisture such as direct

exposure to rain. Excessive moisture can cause the Pulse CO-Oximeter to per-

form inaccurately or fail.

■ Do not place containers with liquids on or near the Pulse CO-Oximeter. Liquids

spilled on the Pulse CO-Oximeter may cause it to perform inaccurately or fail.

■ Failure of Operation - If the Pulse CO-Oximeter fails any part of the setup proce-

dures or leakage tests, remove the Pulse CO-Oximeter from operation until quali-

ﬁ ed 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 CO-Oximeter can be used during deﬁ brillation, 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 interfer-

ence 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 CO-

Oximeter or any sensors.

SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES

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