Onyx Vantage 9590 Finger Pulse Oximeter Instructions for Use

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Description Caution!

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Follow Instructions for Use EC

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0123

Authorized Representative in the European Community CE Marking indicating conformance to EC Directive No. 93/42/EEC concerning medical devices. Type BF Applied Part (patient isolation from electrical shock) Not for Continuous Monitoring (no alarm for SpO2)

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Serial Number Battery orientation 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. Indicates separate collection for electrical and electronic equipment (WEEE).

IP32

Protected against vertically falling water drops when enclosure is tilted up to 15 degrees and ingress of solid foreign objects greater than or equal to 2.5 mm (0.1 in.) diameter per IEC 60529. RoHS compliant (China) Latex Free

Installing Batteries Two 1.5 volt AAA-size batteries power the 9590 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 9590 as shown in figure A. To release the device’s 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 then 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 Vantage 9590 and Verifying Operation section for more information.

B C A

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Activating the Onyx Vantage 9590 and Verifying Operation %SpO2

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 9590 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. Pulse Quality Indicator

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 9590 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 device 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 9590; 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 2minute period of inadequate pulse signals.

Using the Lanyard WARNING: Certain activities may pose a risk of injury, including strangulation, if lanyard should become wrapped around your neck.

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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 is provided for convenience. The device will function with or without the lanyard. If lanyard use is desired, thread the lanyard as shown below.

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Onyx Vantage 9590 Care, Maintenance, and Cleaning The advanced digital circuitry within the device requires no calibration or periodic maintenance other than battery replacement. Field repair of the 9590 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 9590 more than 90°, and do not twist or pull on the device when cleaning.

Cleaning the Onyx Vantage 9590 !

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CAUTIONS: Clean the device before applying it to a 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 mild detergent or 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.

Testing Summary SpO2 accuracy, motion, and low perfusion testing was conducted by Nonin Medical, Inc. as described below.

SpO2 Accuracy Testing During Motion and Non-motion SpO2 accuracy testing is conducted during induced hypoxia studies on healthy, non-smoking, light-to-dark-skinned 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-mean-squared (Arms value) for all subjects, per ISO 9919, Standard Specification for Pulse Oximeters for Accuracy.

Pulse Rate Motion Testing This test measures pulse rate oximeter accuracy with motion artifact simulation introduced by a pulse oximeter tester. This test determines whether the oximeter meets the criteria of ISO 9919 for pulse rate during simulated movement, tremor, and spike motions.

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 9919 for pulse rate and SpO2 at the lowest obtainable pulse amplitude (0.3% modulation).

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Specifications Oxygen Saturation Display Range:

0% to 100% SpO2

Pulse Rate Display Range:

18 to 321 beats per minute (BPM)

Declared Accuracy: The tables below show Arms values measured using the Onyx Vantage 9590 in a clinical study in motion and non-motion conditions. Accuracy Summary by Decade – Finger and Thumb Decade

Oxygen Saturation (Arms)

70 – 80%

±2

Low Perfusion Motion Oxygen Saturation Motion Oxygen Saturation Oxygen Saturation (Arms) (Arms) (Finger) (Arms) (Thumb) ±2

±3

±3

80 – 90%

±2

±2

±3

±4

90 – 100%

±2

±2

±2

±3

70 – 100%

±2

±2

±3

±3

Accuracy Summary by Decade – Toe Decade

Oxygen Saturation (Arms)

70 – 80%

±2

80 – 90%

±3

90 – 100%

±3

70 – 100%

±3

This graph shows plots of the error (SpO2 – SaO2) by SaO2 using the 9590 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.

This graph shows plots of the error (SpO2 – SaO2) by SaO2 using the 9590 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 motion conditions.

This graph shows plots of the error (SpO2 – SaO2) by SaO2 using the 9590 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 using toes in non-motion conditions.

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Pulse Rate Declared Accuracy Range (Arms*):

20 to 250 BPM ±3 digits

Low Perfusion Pulse Rate Declared Accuracy Range (Arms*):

40 to 240 BPM ±3 digits

Motion Pulse Rate Declared Accuracy Range (Arms*):

40 to 240 BPM ±3 digits

Measurement Wavelengths and Output Power**: Red:

660 nanometers @ 0.8 mW maximum average

Infrared:

910 nanometers @ 1.2 mW maximum average

Operating:

-5 °C to 40 °C (23 °F to 104 °F)

Storage/Transportation:

-40 °C to 70 °C (-40 °F to 158 °F)

Operating:

10% to 90% non-condensing

Storage/Transportation:

10% to 95% non-condensing

Operating:

Up to 12,192 meters (40,000 feet)

Hyperbaric Pressure:

Up to 4 atmospheres

Operating:

Approximately 6,000 spot checks or 36 hours of continuous operation using new alkaline batteries.

Storage:

12 months

Temperature:

Humidity:

Altitude:

Battery Life:

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. *± 1 Arms represents approximately 68% of measurements. **This information is especially useful for clinicians performing photodynamic therapy.

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Warranty NONIN MEDICAL, INCORPORATED, (Nonin) warrants to the purchaser, for a period of 4 years from the date of purchase, each Onyx Vantage 9590 exclusive of the batteries, spring, lanyard, and lanyard lock. Nonin shall repair or replace any Onyx Vantage 9590 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 Vantage 9590 delivered to the purchaser which is found to be defective in any manner whether such remedies be in contract, tort or by law. 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 Vantage 9590 found to be within specifications. Onyx Vantage 9590 is a precision electronic instrument and must be repaired by trained Nonin personnel only. Any sign or evidence of opening the Onyx Vantage 9590, field service by non-Nonin personnel, tampering, or any kind of misuse of the Onyx Vantage 9590, 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. 13700 1st Avenue North Plymouth, Minnesota 55441-5443 USA (800) 356-8874 (USA and Canada) +1 (763) 553-9968 (outside USA and Canada) Fax: +1 (763) 553-7807 E-mail: [email protected] www.nonin.com

Nonin Medical AB Fibervägen 2 82450 Hudiksvall, Sweden +46 650 401500 (Europe) Fax: +46 650 401514 E-mail: [email protected] www.nonin.com

Manufacturer’s Declaration Refer to the following tables for specific information regarding this device’s compliance to IEC 60601-1-2. Table 1: Electromagnetic Emissions Emissions Test

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

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.

RF Emissions CISPR 11

Class B

Harmonic Emissions IEC 61000-3-2

N/A

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.

Voltage Fluctuations/Flicker Emissions IEC 61000-3-3

N/A

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Table 2: Electromagnetic Immunity Immunity Test

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. Electrostatic Discharge (ESD) IEC 61000-4-2

±6 kV contact ±8 kV air

±6 kV contact Floors should be wood, concrete, or ±8 kV air ceramic tile. If floors are covered with synthetic material, relative humidity 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 N/A ±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.

Mains power quality should be that of a typical commercial or hospital environment.

Power Frequency (50/60 Hz) Magnetic Field IEC 61000-4-8

3 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

3 A/m

NOTE: UT is the AC mains voltage before application of the test level.

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Table 3: Guidance and Manufacturer’s Declaration-Electromagnetic Immunity Immunity Test

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 Conducted RF IEC 61000-4-6

3 Vrms N/A 150 kHz to 80 MHz

d = 1.17 P

Radiated RF IEC 61000-4-3

3 V/m [3] V/m 80 MHz to 2.5 GHz

80 MHz to 800 MHz d = 1.17 P

Radiated RF per ISO 9919 clause 36 and ISO 80601-2-61 clause 202.6.2.3

20 V/m [20] V/m 80 MHz to 2.5 GHz

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).

800 MHz to 2.5 GHz d = 2.33 P

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 [3] V/m.

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.

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The following table details the recommended separation distances between portable and mobile RF communications equipment and this device. 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 d = 1.17 P

80 MHz to 800 MHz d = 1.17 P

800 MHz to 2.5 GHz 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.

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