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IMporTAnT sAfeguArds/InTroduCTIon
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WArnIng
• This oximeter is an accessory to the DV5M SmartLink Module. Only connect to this approved product.
• Do not use the XPOD oximeter in an MRI environment.
• Explosion Hazard– Do not use the XPOD oximeter in an explosive atmosphere or in the presence of flammable
anesthetics or gases.
• Strangulation Hazard– As with all medical equipment, carefully route cables and connections to reduce the
possibility of entanglement or strangulation.
• Inspect the sensor application site at least every 6 to 8 hours to ensure correct sensor alignment and skin integrity.
Patient sensitivity may vary due to medical status or skin condition. Discontinue use of adhesive tape strips if the
patient exhibits an allergic reaction to the adhesive material.
• Pacemaker Patients – Rate meters may continue to count the pacemaker rate during occurrences of cardiac arrest
or some arrhythmias. Do not rely entirely upon rate meter alarms. Keep pacemaker patients under close
surveillance.
CAuTIon
• To prevent product damage, do not submerse device in either water or any other fluid and do not use caustic or abrasive cleaning agents.
• Loss of monitoring can result if any objects hinder the pulse measurement. Ensure that no blood flow restrictors (e.g., blood pressure cuff)
hinder pulse measurements.
• Use only NONIN-manufactured PureLight® pulse oximeter sensors. These sensors are manufactured to meet the accuracy specifications for
NONIN pulse oximeters. Using other manufacturers’ sensors can result in improper pulse oximeter performance.
• This device does not meet defibrillation-proof requirements per IEC 60601-1: 1990, clause 17.h. To prevent product damage, do not defibrillate
a patient while attached to the XPOD oximeter.
• This device should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the device should be
observed carefully to verify normal operation.
• The accuracy of the SpO
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measurement may be affected if the total cable length (including extension cables) is greater than 3 meters.
• The use of accessories, sensors, and cables other than those specified by NONIN (except transducers and cables sold by NONIN as
replacement parts for internal components) may result in increased emission and/or decreased immunity of this device.
• This pulse oximetry system is designed to determine the percentage of arterial oxygen saturation of functional hemoglobin. Significant levels of
dysfunctional hemoglobin, such as methemoglobin, might affect the accuracy of the measurement.
• The XPOD oximeter has motion tolerant software that minimizes the likelihood of motion artifact being misinterpreted as good pulse quality. In
some circumstances, however, the XPOD oximeter may still interpret motion as good pulse quality. This covers all available outputs.
• This equipment complies with International Standard EN 60601-1-2:2001 for electromagnetic compatibility for medical electrical equipment and/
or systems. This standard is designed to provide reasonable protection against harmful interference in a typical medical installation. However,
because of the proliferation of radio frequency transmitting equipment and other sources of electrical noise in healthcare and other
environments, it is possible that high levels of interference due to close proximity or strength of a source might disrupt the device’s
performance. Medical electrical equipment needs special precautions regarding EMC, and all equipment must be installed and put into service
according to the EMC information specified in this document. Portable and mobile RF communications equipment can affect medical electrical
equipment.
For more information about required safety and regulatory requirements for medical devices, refer to EN865 and IEC 60601-1. Additional safety
information can be found in the labeling provided with each Nonin sensor.
InTRoDUCTIon
Your clinician may have supplied an oximeter for use with the DV5M SmartLink system. Connecting an oximeter to the SmartLink allows collection
and storage of oximetry data (oxygen saturation and pulse rate).
When using the optional oximeter with the SmartLink, follow the directions below for connecting the oximeter. The only oximeter compatible with
this product is the Nonin XPOD Oximeter. Use only the Nonin 7000A, 8000AA, or 8000J sensors. Once the oximeter is plugged into the
SmartLink, the oximeter will be powered and ready for use.