Instructions for Use Installing Batteries Two 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. Onyx® II Model 9550 Finger Pulse Oximeter Indications for Use II The 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. 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. 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. B C A Activating the Onyx II 9550 and Verifying Operation II 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: • do not apply the pulse • excessive motion • anemia or low hemoglobin oximeter on the same arm as • moisture in the device concentrations a blood pressure cuff, arterial • improperly applied device • cardiogreen and other catheter or infusion line(s) • finger is outside intravascular dyes (IVs) recommended size range • carboxyhemoglobin • excessive light, such as • poor pulse quality • methemoglobin sunlight or direct home • venous pulsations • dysfunctional hemoglobin lighting • artificial nails or fingernail polish • 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 radiofrequency 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. Pulse Quality Indicator The 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 Case WARNING: 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. Symbols Symbol Definition of Symbol Consult Instructions for Use Onyx II 9550 Care, Maintenance, and Cleaning Follow Instructions for Use The 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. Caution! ! Type BF Applied Part (patient isolation from electrical shock) Cleaning the Onyx II 9550 Not for Continuous Monitoring (no alarm for SpO2) SN ! Serial Number • 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. C UL D C Battery Orientation SSIFIE LA US UL 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. 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. 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). EC REP Equipment Response Time Authorized Representative in the European Community IPX2 Protected against vertically falling water drops when enclosure is tilted up to 15 degrees, per IEC 60529. IP32 Protected 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. nonin.com +1 (763) 553-9968 (outside US and Canada) +31 (0)13 - 79 99 040 (Europe) (800) 356-8874 (US and Canada) SpO2 Values Average Standard/Fast Averages SpO2 4 beat exponential 2 beats Pulse Rate Values Response Latency Latency Standard/Fast Averages Pulse Rate 4 beat exponential 2 beats Example: SpO2 Exponential Averaging SpO2 decreases 0.75% per second; pulse rate = 75 BPM The response of the 4-beat average is 1.5 seconds. RoHS Compliant (China) Nonin Medical, Inc. 13700 1st Avenue North Plymouth, Minnesota 55441-5443 USA CAUTIONS: Fax: +1 (763) 553-7807 +31 (0)13 - 79 99 042 (Europe) E-mail: email@example.com firstname.lastname@example.org (Europe) EC REP MPS, Medical Product Service GmbH Borngasse 20 D-35619 Braunfels, Germany Nonin and Onyx are registered trademarks of Nonin Medical, Inc. U.S. Patents 5,490,523; 5,792,052 © 2013 Nonin Medical, Inc. 7750-101-04 Manufacturer’s Declaration Testing Summary Refer to the following tables for specific information regarding this device’s compliance to IEC 60601-1-2. SpO2 accuracy and low perfusion testing was conducted by Nonin Medical, Incorporated as described below. Table 1: Electromagnetic Emissions Emissions Test SpO2 Accuracy Testing SpO2 accuracy testing is conducted during induced hypoxia studies on healthy, non-smoking, light-to-darkskinned subjects in an independent research laboratory. The measured arterial hemoglobin saturation value (SpO2) of the device is compared to arterial hemoglobin oxygen (SaO2) value, determined from blood samples with a laboratory co-oximeter. The accuracy of the device is in comparison to the co-oximeter samples measured over the SpO2 range of 70-100%. Accuracy data is calculated using the root-meansquared (Arms value) for all subjects, per ISO 80601-2-61 and ISO 9919, Standard Specification for Pulse Oximeters for Accuracy. Low Perfusion Testing This test uses an SpO2 Simulator to provide a simulated pulse rate, with adjustable amplitude settings of various SpO2 levels. The device must maintain accuracy in accordance with ISO 80601-2-61 and ISO 9919 for pulse rate and SpO2 at the lowest obtainable pulse amplitude (0.3% modulation). Principles of Operation Pulse oximetry is a non-invasive method that passes red and infrared light through perfused tissue and detects the fluctuating signals caused by arterial pulses. Well-oxygenated blood is bright red, while poorly oxygenated blood is dark red. The pulse oximeter determines functional oxygen saturation of arterial hemoglobin (SpO2) from this color difference by measuring the ratio of absorbed red and infrared light as volume fluctuates with each pulse. Compliance Electromagnetic Environment—Guidance This device is intended for use in the electromagnetic environment specified below. The customer and/or user of this device should ensure that it is used in such an environment. RF Emissions CISPR 11 Group 1 RF Emissions CISPR 11 Class B Harmonic Emissions IEC 61000-3-2 N/A Voltage Fluctuations/Flicker Emissions IEC 61000-3-3 N/A This device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. This device is suitable for use in all establishments, including domestic and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes. Table 2: Electromagnetic Immunity Immunity Test Compliance Level IEC 60601 Test Level Electromagnetic Environment— Guidance This device is intended for use in the electromagnetic environment specified below. The customer and/or user of this device should ensure that it is used in such an environment. Specifications Oxygen Saturation Display Range: 0% to 100% SpO2 Pulse Rate Display Range: 18 to 321 beats per minute (BPM) Declared Accuracy: The table below shows Arms values measured using the Onyx II 9550 in a clinical study in non-motion conditions. Accuracy Summary by Decade Decade Oxygen Saturation (Arms) 70 – 80% 80 – 90% 90 – 100% 70 – 100% ±2 ±2 ±2 ±2 Low Perfusion Oxygen Saturation (Arms) ±2 ±2 ±2 ±2 This graph shows plots of the error (SpO2 – SaO2) by SaO2 using the 9550 with a linear regression fit and upper 95% and lower 95% limits of agreement. Each sample data point is identified by subject from a clinical study in non-motion conditions. Electrostatic Discharge (ESD) IEC 61000-4-2 ±6 kV contact ±8 kV air Floors should be wood, concrete, or ±6 kV contact ceramic tile. If floors are covered with synthetic material, relative humidity ±8 kV air should be at least 30%. Electrical Fast Transient/Burst IEC 61000-4-4 ±2 kV for power supply lines ±1 kV for input/output lines N/A Mains power quality should be that of a typical commercial or hospital environment. Surge IEC 61000-4-5 ±1 kV differential mode ±2 kV common mode N/A Mains power quality should be that of a typical commercial or hospital environment. Voltage dips, short interruptions, and voltage variations on power supply input lines IEC 61000-4-11 ±5% UT (>95% dip in UT) for 0.5 cycle ±40% UT (60% dip in UT) for 5 cycles ±70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec. N/A Mains power quality should be that of a typical commercial or hospital environment. 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Power Frequency (50/ 60 Hz) Magnetic Field 3 A/m IEC 61000-4-8 NOTE: UT is the AC mains voltage before application of the test level. Table 3: Guidance and Manufacturer’s Declaration—Electromagnetic Immunity Immunity Test Pulse Rate Declared Accuracy Range (Arms*): Low Perfusion Pulse Rate Declared Accuracy Range (Arms*): Measurement Wavelengths and Output Power**: Red: Infrared: Temperature: Operating Storage/Transportation: Humidity: Operating: Storage/Transportation: Altitude: Operating Hyperbaric Pressure: Battery Life: Operating 20 to 250 BPM ±3 digits 40 to 240 ±3 digits 660 nanometers @ 0.8 mW maximum average 910 nanometers @ 1.2 mW maximum average IEC 60601 Test Level Compliance Level Electromagnetic Environment—Guidance This device is intended for use in the electromagnetic environment specified below. The customer and/or user of this device should ensure that it is used in such an environment. Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended Separation Distance -5 °C to 40 °C (23 °F to 104 °F) -40 °C to 70 °C (-40 °F to 158 °F) Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz 10% to 95% non-condensing 10% to 95% non-condensing Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.5 GHz Radiated RF per ISO 9919 clause 36 and ISO 80601-2-61 clause 18.104.22.168 20 V/m 80 MHz to 2.5 GHz Up to 40,000 feet / 12,192 meters Up to 4 atmospheres Approximately 6,000 spot checks, or 36 hours of continuous operation using new alkaline batteries. Storage: 48 months Classifications per IEC 60601-1 / CAN/CSA-C22.2 No. 601.1 / UL 60601-1: Degree of Protection: Type BF-Applied Part Enclosure Degree of Ingress Protection: IP32 Mode of Operation: Continuous This product complies with ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing. This device is not made with natural rubber latex. *± 1 Arms represents approximately 68% of measurements. **This information is especially useful for clinicians performing photodynamic therapy. Warranty d = 1.17 P N/A  V/m  V/m 80 MHz to 800 MHz 800 MHz to 2.5 GHz d = 1.17 P d = 2.33 P where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol: a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than  V/m. NONIN MEDICAL, INCORPORATED, (Nonin) warrants to the purchaser, for a period of 7 years from the date of purchase, each Onyx II 9550 exclusive of the batteries, spring, carrying case, lanyard, and lanyard lock. NOTES: • At 80 MHz and 800 MHz, the higher frequency range applies. • These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. Nonin shall repair or replace any Onyx found to be defective in accordance with this warranty, free of charge, for which Nonin has been notified by the purchaser by serial number that there is a defect, provided notification occurs within the applicable warranty period. This warranty shall be the sole and exclusive remedy by the purchaser hereunder for any Onyx delivered to the purchaser which is found to be defective in any manner whether such remedies be in contract, tort or by law. The following table details the recommended separation distances between portable and mobile RF communications equipment and this device. This warranty excludes cost of delivery to and from Nonin. All repaired units shall be received by the purchaser at Nonin’s place of business. Nonin reserves the right to charge a fee for a warranty repair request on any Onyx found to be within specifications. Onyx is a precision electronic instrument and must be repaired by trained Nonin personnel only. Any sign or evidence of opening the Onyx, field service by non-Nonin personnel, tampering, or any kind of misuse of the Onyx, shall void the warranty. All non-warranty work shall be done at Nonin’s standard rates and charges in effect at the time of delivery to Nonin. Nonin Medical, Inc. Nonin Medical B.V. 13700 1st Avenue North Prins Hendriklaan 26 Plymouth, Minnesota 55441-5443 USA 1075 BD Amsterdam, Netherlands (800) 356-8874 (USA and Canada) +1 (763) 553-9968 (outside USA and Canada) Fax: +1 (763) 553-7807 E-mail: email@example.com +31 (0)13 - 79 99 040 (Europe) Fax: +31 (0)13 - 79 99 042 E-mail: firstname.lastname@example.org www.nonin.com Military/Safe-to-Fly Information Nonin Medical’s Onyx II 9550 has completed aeromedical test and evaluation by the U.S. Department of Army and has received a “Safe-to-Fly” recommendation from the Department of the Air Force. The Onyx II 9550 carries a NATO Stock Number or National Stock Number (NSN). For additional information, contact email@example.com Table 4: Recommended Separation Distances This device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. Users of this device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and the device as recommended below, according to maximum output power of the communications equipment. Separation Distance According to Frequency of Transmitter Rated Maximum Output Power of Transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz d = 1.17 P d = 1.17 P d = 2.33 P 0.01 0.12 0.12 0.23 0.1 0.37 0.37 0.74 1 1.2 1.2 2.3 10 3.7 3.7 7.4 100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTES: • At 80 MHz and 800 MHz, the higher frequency range applies. • These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.