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© 2013 Nonin Medical, Inc.7750-101-04MPS, Medical Product Service GmbHBorngasse 20D-35619 Braunfels, GermanyNonin and Onyx are registered trademarks of Nonin Medical, Inc.U.S. Patents 5,490,523; 5,792,052ECREPNonin Medical, Inc.13700 1st Avenue NorthPlymouth, Minnesota 55441-5443 USAnonin.com+1 (763) 553-9968 (outside US and Canada)+31 (0)13 - 79 99 040 (Europe)(800) 356-8874 (US and Canada)Fax: +1 (763) 553-7807 +31 (0)13 - 79 99 042 (Europe)E-mail: info@nonin.com infointl@nonin.com (Europe)Instructions for UseOnyx® II Model 9550 Finger Pulse OximeterIndications for UseThe Nonin® Onyx II Model 9550 Finger Pulse Oximeter is a small, lightweight, portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate of patients who are well or poorly perfused. It is intended for spot-checking of adult and pediatric patients on fingers (other than the thumb) between 0.3 – 1.0 inch (0.8 – 2.5 cm) thick. The device’s intended use environments include hospitals, clinics, long-term care facilities, skilled nursing facilities, emergency medical services, and home healthcare services.Caution: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner.Contraindications• Do not use the device in an MR environment, in an explosive atmosphere, or on infant or neonatal patients.• This device is not defibrillation proof per IEC 60601-1.Warnings• Inspect the sensor application site at least every 6 to 8 hours to ensure correct sensor alignment and skin integrity. Patient sensitivity to the sensor may vary due to medical status or skin condition.• Avoid excessive pressure to the sensor application site as this may cause damage to the skin beneath the sensor.• This device is intended only as an adjunct in patient assessment. It must be used in conjunction with other methods of assessing clinical signs and symptoms.• The device must be able to measure the pulse properly to obtain an accurate SpO2 measurement. Verify that nothing is hindering the pulse measurement before relying on the SpO2 measurement. • Operation of this device below the minimum amplitude of 0.3% modulation may cause inaccurate results. • General operation of the device may be affected by the use of an electrosurgical unit (ESU).• The use of accessories other than those specified in these instructions may result in increased electromagnetic emission and/or decreased immunity of this device. • 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.• Keep the oximeter away from young children. Small items such as the battery door, battery, and lanyard are choking hazards.• Certain activities may pose a risk of injury, including strangulation, if lanyard should become wrapped around your neck.Cautions• This device has no audible alarms and is intended only for spot-checking.• This device is designed to determine the percentage of arterial oxygen saturation of functional hemoglobin. Factors that may degrade pulse oximeter performance or affect the accuracy of the measurement include the following:• The device may not work when circulation is reduced. Warm or rub the finger, or re-position the device.• This device’s display will go blank after 30 seconds of no readings or poor readings.• In some circumstances, the device may interpret motion as good pulse quality. Minimize patient motion as much as possible.• Cardiogreen and other intravascular dyes may affect the accuracy of the SpO2 measurement.• Clean the device before applying it to a new patient.• Do not sterilize, autoclave, or immerse this device in liquid. Do not pour or spray any liquids onto the device.• Do not use caustic or abrasive cleaning agents, or any cleaning agent containing ammonium chloride or isopropyl alcohol. • This device is a precision electronic instrument and must be repaired by qualified technical professionals. Field repair of the device is not possible. Do not attempt to open the case or repair the electronics. Opening the case may damage the device and void the warranty.• A flexible circuit connects the two halves. Do not twist or pull the flexible circuit or overextend the device’s spring.• Do not hang the lanyard from the device’s flexible circuit.• A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor or sensor.• This equipment complies with IEC 60601-1-2 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 such interference due to close proximity or strength of a source might disrupt the performance of this device. 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 manual. • Portable and mobile RF communications equipment can affect medical electrical equipment.• Batteries may leak or explode if used or disposed of improperly. Remove batteries if the device will be stored for more than 30 days. Do not use different types of batteries at the same time. Do not mix fully charged and partially charged batteries at the same time. These actions may cause the batteries to leak.• Follow local, state and national governing ordinances and recycling instructions regarding disposal or recycling of the device and device components, including batteries.• In compliance with the European Directive on Waste Electrical and Electronic Equipment (WEEE) 2002/96/EC, do not dispose of this product as unsorted municipal waste. This device contains WEEE materials; please contact your distributor regarding take-back or recycling of the device. If you are unsure how to reach your distributor, please call Nonin for your distributor’s contact information.SymbolsSymbolDefinition of SymbolConsult Instructions for UseFollow Instructions for Use !Caution!Type BF Applied Part (patient isolation from electrical shock)Not for Continuous Monitoring (no alarm for SpO2)SNSerial NumberBattery OrientationCLASSIFIEDUSCULUL Mark for Canada and the United States with respect to electric shock, fire, and mechanical hazards only in accordance with UL 60601-1 and CAN/CSA C22.2 No. 601.1.Non-ionizing electromagnetic radiation. Equipment includes RF transmitters. Interference may occur in the vicinity of equipment marked with this symbol.Indicates separate collection for electrical and electronic equipment (WEEE).ECREPAuthorized Representative in the European CommunityIPX2Protected against vertically falling water drops when enclosure is tilted up to 15 degrees, per IEC 60529.IP32Protected against vertically falling water drops when enclosure is tilted up to 15 degrees and ingress of solid foreign objects greater than 2.5 mm (0.1 in.) diameter per IEC 60529.RoHS Compliant (China)II!• do not apply the pulse oximeter on the same arm as a blood pressure cuff, arterial catheter or infusion line(s) (IVs)• excessive light, such as sunlight or direct home lighting• excessive motion• moisture in the device• improperly applied device• finger is outside recommended size range• poor pulse quality• venous pulsations• anemia or low hemoglobin concentrations• cardiogreen and other intravascular dyes• carboxyhemoglobin• methemoglobin• dysfunctional hemoglobin• artificial nails or fingernail polishInstalling BatteriesTwo 1.5 volt AAA-size batteries power the 9550 for about 6,000 spot checks or 36 hours of operation. Nonin recommends using alkaline batteries (included with each new device). When batteries are low, the numeric displays flash once per second. Remove batteries if the device will be stored for more than 30 days. Replace low batteries as soon as possible, using the instructions below. NOTE: Rechargeable batteries may be used; however, they require more frequent replacement.1. Hold the 9550 as shown in figure A. To release the battery tray, press upward and then pull outward slightly with the thumb.2. Remove the old batteries from the battery tray. Dispose of the batteries properly.3. Insert two new 1.5 volt AAA-size batteries. Follow the polarity markings (+ and -) as illustrated in figure B. Proper positioning of the batteries is essential for operation.4. Carefully guide the battery tray back onto the device. Press downward and push inward slightly to re-secure the battery tray (figure C). Do not force it into place; it fits only when properly positioned.5. Insert your finger into the device to verify operation. See the Activating the Onyx II 9550 and Verifying Operation section for more information.Activating the Onyx II 9550 and Verifying OperationThe device contains numeric Light-Emitting Diodes (LEDs) that display oxygen saturation and pulse rate. A tricolor LED display (pulse quality indicator, shown at left) provides a visual indication of the pulse signal quality, while blinking at the corresponding pulse rate. This display changes colors to alert you to changes in pulse quality that may affect the readings:•Green indicates a good pulse signal. •Yellow indicates a marginal pulse signal. •Red indicates an inadequate pulse signal.Activate the 9550 by inserting the patient’s finger into the device. The device detects the inserted finger and automatically illuminates the displays. Correct positioning of the device on the finger is critical for accurate measurements. NOTE: While on the finger, do not press the device against any surface and do not squeeze or hold it together. The internal spring provides the correct pressure; additional pressure may cause inaccurate readings.1. Insert the patient’s finger, nail side up, into the 9550 until the fingertip touches the built-in stop guide.2. Make sure the finger is lying flat (not on its side) and is centered within the device. For best results, keep the 9550 at the patient’s heart or chest level.3. If the device does not turn on, remove the finger and wait a few seconds before reinserting it.When a finger is inserted, the device performs a brief startup sequence. Verify that all LEDs illuminate during the startup sequence. If any LED is not lit, do not use the 9550; contact Nonin Customer Support for repair or replacement. After the startup sequence, the device begins sensing the pulse (indicated by the blinking pulse quality indicator). Allow the device to stabilize and observe about 4 seconds of continuous green-colored pulse quality before relying on the displayed values. It is common for the displayed values to fluctuate slightly over a period of several seconds. If the pulse quality indicator blinks yellow or red, try another finger. A minus sign (-) appears in the left-most digit of the %SpO2 display when the device senses the finger has been removed. The last measured SpO2 and pulse rate values display for 10 seconds while the device automatically turns off. The device will automatically shut off (to conserve battery life) approximately 10 seconds after the finger is removed, or after a 2-minute period of inadequate pulse signals.Using the Lanyard and Carrying CaseWARNING: Certain activities my pose a risk of injury, including strangulation, if lanyard should become wrapped around your neck.CAUTION: A flexible circuit connects the two halves. Do not twist or pull the flexible circuit or overextend the device’s spring. Do not hang the lanyard from the device’s flexible circuit.A lanyard and carrying case are provided for convenience. The device will function with or without the lanyard.If lanyard use is desired, thread the lanyard as shown below.Onyx II 9550 Care, Maintenance, and CleaningThe advanced digital circuitry within the device requires no calibration or periodic maintenance other than battery replacement. Field repair of the 9550 circuitry is not possible. Do not attempt to open the case or repair the electronics. Opening the case will damage the device and void the warranty. Do not open the 9550 more than 90°, and do not twist or pull on the device when cleaning.Cleaning the Onyx II 9550CAUTIONS:!• Clean the device before applying it to a new patient.• Do not sterilize, autoclave, or immerse this device in liquid. Do not pour or spray any liquids onto the device.•Do not use caustic or abrasive cleaning agents, or any cleaning agent containing ammonium chloride or isopropyl alcohol. 1. To clean, wipe the surfaces with a soft cloth dampened with a 10% bleach solution (household bleach [5.25% sodium hypochlorite]). Do not use undiluted bleach or any cleaning solution other than those recommended here, as permanent damage could result.2. Dry with a soft cloth, or allow to air dry. Ensure that all surfaces are completely dry.Equipment Response TimeExample: SpO2Exponential AveragingSpO2 decreases 0.75% per second; pulse rate = 75 BPMThe response of the 4-beat average is 1.5 seconds.BCAIIPulse Quality Indicator!SpO2 ValuesAverageLatencyStandard/Fast Averages SpO24 beat exponential 2 beatsPulse Rate ValuesResponseLatencyStandard/Fast Averages Pulse Rate 4 beat exponential 2 beats