Safety considerations, Warnings – ZOLL R Series Monitor Defibrillator Rev D User Manual

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Safety Considerations

9650-0901-01 Rev. D

R Series Pulse Oximetry (SpO

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)

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Safety Considerations

Warnings

General

Carefully read your defibrillator’s R Series Operator’s Guide, these operating instructions, and
the Directions for Use that accompany the Masimo oximeter sensors.

Only qualified personnel should operate the R Series pulse oximeter.

Do not use the pulse oximeter as an apnea monitor.

Do not immerse the R Series defibrillator, cables, or sensors in water, solvents, or cleaning
solutions.

Consider a pulse oximeter an early warning device. When a trend toward patient deoxygenation
is indicated, blood samples should be analyzed by a laboratory co-oximeter to completely
understand the patient’s condition.

If an alarm occurs while audible alarms are suspended, only visual alarm indicators are
provided.

Interfering substances: Carboxyhemoglobin and methemoglobin can erroneously alter SpO

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readings. The level of change is approximately equal to the amount of carboxyhemoglobin or
methemoglobin present. Dyes or any substance containing dyes that alter arterial pigmentation
might cause erroneous readings.

Do not use the R Series pulse oximeter or oximeter sensors during magnetic resonance imaging
(MRI). Induced current could cause burns. The pulse oximeter might affect the MRI image and
the MRI unit might interfere with the accuracy of oximetry measurements.

Carefully arrange patient cabling to reduce the possibility of patient entanglement or
strangulation.

Use only the line cord supplied by ZOLL Medical Corporation for continued safety and EMC
performance.

Oximeter sensors

Use only ZOLL/Masimo LNCS oximeter sensors. Other manufacturers’ sensors might not
perform properly with the R Series oximeter.

Tissue damage can result from incorrect application or use of a sensor (for example, wrapping
the sensor too tightly, applying supplemental tape, failing to periodically inspect the sensor
site). To ensure skin integrity, correct positioning, and sensor adhesion, inspect the sensor site
as directed in the Directions for Use provided with the sensor.

Do not use damaged sensors or cables.

Do not use a sensor with exposed optical components.

Do not sterilize a sensor by irradiation, steam, or ethylene oxide. Refer to the cleaning
instructions in the Directions for Use for reusable LNCS sensors.

Do not allow the sensor to remain on the same site for a prolonged period, especially when
monitoring neonates. Check the application site at regular intervals (at least every 2 hours) and
change the site if any compromise in skin quality occurs.

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