ZOLL R Series User Manual

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Pulse Oximetry (SpO2)

December 2008

9650-0901-01 Rev. D

An issue date and revision level for this manual appear on the front cover. If more than three years have elapsed since this date, contact ZOLL Medical Corporation to determine if additional product information updates are available.

ZOLL, R Series, and “Advancing Resuscitation. Today.” are registered trademarks, and OneStep is a trademark of ZOLL Medical Corporation. All other trademarks and registered trademarks are property of their respective owners.

Copyright © 2008 ZOLL Medical Corporation. All rights reserved.

Pulse Oximetry (SpO2)

Product Description

The R Series® pulse oximeter continuously and noninvasively measures the oxygen saturation of arteriolar hemoglobin at a peripheral site (e.g., foot, toe, or finger). It is used to monitor patients at risk of developing hypoxemia. SpO2 monitoring provides information about the circulatory and respiratory systems and supplies details of oxygen transportation in the body. This option is widely used because it is noninvasive, continuous, easily applied, and painless.

The oximeter sensor contains two emitters that transmit red and infrared light through the monitored site. This light passes through the patient’s tissues and is received by a photodetector in the sensor. Because oxygen-saturated blood absorbs light differently than unsaturated blood, the amount of red and infrared light absorbed by blood flowing through the monitored site can be used to calculate the ratio of oxygenated hemoglobin to total hemoglobin in arterial blood. The monitor displays this ratio as percent SpO2. Normal values typically range from 95% to 100% at sea level.

The quality of SpO2 measurements depends on the correct size and application of the oximetry sensor, adequate blood flow through the sensor site, and the sensor’s exposure to ambient light. For correct placement and location of the sensors, refer to the Directions for Use contained in all LNCS® oximetry sensor packages.

How to Use This Insert

This insert supplements your defibrillator’s R Series Operator’s Guide and describes how to set up, use, and maintain the R Series pulse oximeter. Keep this insert with your defibrillator’s

R Series Operator’s Guide and all other inserts for R Series options.

Your defibrillator’s R Series Operator’s Guide provides information that users need for the safe and effective use and care of R Series products. Important safety information related to use of the R Series pulse oximeter appears in “Safety Considerations” on page 3. Additional important safety information is packaged with each oximetry sensor.

SpO2 Intended Use

The R Series pulse oximeter, with the Masimo® SET® technology and the LNCS series of oximeter sensors, is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate.

The R Series pulse oximeter is indicated for use with adult, pediatric, and neonatal patients during both no-motion and motion conditions, and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, and mobile environments.

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R SERIES — PULSE OXIMETRY (SPO2) OPTION INSERT

Oxygen saturation measurements derived from pulse oximetry are highly dependent on patient conditions and proper placement of the sensor. Patient conditions such as smoke inhalation might result in erroneous oxygen saturation readings. If the accuracy of any reading is in doubt, verify the reading using another clinically accepted method, such as arterial blood gas measurements.

The R Series Pulse Oximetry option is intended for use only with ZOLL/Masimo LNCS sensors.

Measurement Complications

If the accuracy of any reading is suspect, first check the patient’s vital signs by alternate means and then check the R Series Pulse Oximeter for proper functioning.

Inaccurate measurements may be caused by:

Incorrect sensor application or use.

Significant levels of dysfunctional hemoglobins (for example, carboxyhemoglobin or methemoglobin).

Intravascular dyes, such as indocyanine green or methylene blue.

Exposure to excessive illumination, such as surgical lamps (especially those with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, or direct sunlight.

Excessive patient movement.

Patient conditions, such as smoke inhalation.

Venous pulsations.

Certain nail aberrations, nail polish, fungus, and so on.

Placement of a sensor on a limb with restricted blood flow, a blood pressure cuff, an arterial catheter, or an intravascular line.

A weak pulse signal on the display might indicate a poorly applied sensor or a poorly chosen monitoring site. Loss of pulse signal can occur when:

The sensor is applied too tightly.

There is excessive illumination from light sources, such as a surgical lamp, a bilirubin lamp, or sunlight.

A blood pressure cuff is inflated on the limb used for the oximeter sensor.

Excessive patient movement.

The patient has hypotension, severe vasoconstriction, or hypothermia.

An arterial occlusion exists proximal to the sensor.

The patient is in cardiac arrest or shock.

SPO2 Connector and Sensors

The SpO2 connector is located on the rear panel of the R Series unit. Use only ZOLL or Masimo accessories and sensors with the R Series Pulse Oximetry option.

Each sensor is designed for application to a specific anatomical site on patients within a certain weight range. To ensure optimal performance, use an appropriate sensor, apply it as described in the sensor’s Directions for Use, and always observe all warnings and cautions.

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ZOLL R Series User Manual

Safety Considerations

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 SpO2 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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R Series Pulse Oximetry (SpO2)

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R SERIES — PULSE OXIMETRY (SPO2) OPTION INSERT

Do not attach the oximeter sensor to a limb being monitored with a pressure cuff or with restricted blood flow.

A poorly applied sensor might give incorrect saturation readings. A weak pulse signal on the display might indicate a poorly applied sensor or a poorly chosen monitoring site.

Choose a site with sufficient perfusion to ensure accurate oximetry values.

Certain nail aberrations, nail polish, fungus, and so on might cause inaccurate oximetry readings. Remove any nail polish or move the sensor to an unaffected digit.

Exposure to high ambient light from surgical lamps (especially those with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, or direct sunlight can affect the accuracy of oximetry readings. To prevent interference from ambient light, ensure that the sensor is properly applied. If necessary, cover the sensor with opaque material.

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