Onyx II Model 9550 Finger Pulse Oximeter Instructions for Use

EC

REP

IPX2

Authorized Representative in the European Community Protected against vertically falling water drops when enclosure is tilted up to 15 degrees, per IEC 60529.

Installing Batteries

Two 1.5 volt AAA-size batteries power the Onyx® II for about 2,500 spot checks or 21 hours of operation. NONIN® recommends using alkaline batteries (included with each new Onyx II). 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

11

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1. Hold the Onyx® II as shown at left, pressing upward and then pulling outward slightly with the thumb to release the device’s battery tray. 2. Remove the battery tray and the old batteries, disposing of the batteries properly. 3. Insert two new 1.5 volt AAA-size batteries. Follow the polarity markings (+ and -) as illustrated. Proper positioning of the batteries is essential for operation. 4. Carefully guide the battery tray back onto the Onyx® II, pressing downward and pushing inward slightly to re-secure the battery tray. Do not force it into place; it fits only when properly positioned. 5. Insert your finger into the device to verify operation.

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4

Perfusion Indicator

Activating the Onyx® II and Verifying Operation

The Onyx® II contains numeric LEDs that display oxygen saturation and pulse rate. A tricolor LED display 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, and red indicates an inadequate pulse signal. Activate the Onyx® II by inserting the patient’s finger into the unit. The Onyx® II detects the inserted finger and automatically illuminates the displays. Correct positioning of the light emitter and photodetector on the finger is critical for accurate measurements. All emitted light must pass through the fingertip. While on the finger, do not press the Onyx® II 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 Onyx® II 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 Onyx® II 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 Onyx® II performs a brief startup sequence. Verify that all LEDs illuminate during the startup sequence. If any LED is not lit, do not use the Onyx® II; contact NONIN® Customer Support for repair or replacement. After the startup sequence, the Onyx® II begins sensing the pulse (indicated by the blinking pulse quality display). Allow the device to stabilize, observing 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 display blinks yellow or red, try another finger. A minus sign (-) appears in the left-most digit of the %SpO2 display when the Onyx® II senses that the finger has been removed. The last measured SpO2 and pulse rate values freeze for 10 seconds, and then “OFF” will appear in the display while the device 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

A lanyard and carrying case are provided for convenience. The Onyx® II will function with or without the lanyard. • If lanyard use is desired, thread the lanyard as shown below.

Onyx® II Care, Maintenance, and Cleaning

The advanced digital circuitry within the Onyx® II requires no calibration or periodic maintenance other than battery replacement. Field repair of the Onyx® II circuitry is not possible. Do not attempt to open the Onyx® II case or repair the electronics. Opening the case will damage the Onyx® II and void the warranty. Do not open the Onyx® II more than 90°, and do not twist or pull on the device when cleaning.

Cleaning the Inner Surfaces of the Onyx® II 1. Wipe the surfaces with a soft cloth dampened with a mild detergent or isopropyl alcohol solution. If low-level disinfection is required, a cloth dampened with 10% bleach / 90% water solution may also be used. 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. !

Caution

Do not use caustic or abrasive cleaning agents. 3. Ensure that all surfaces are completely dry.

Testing Summary SpO2 accuracy and low perfusion testing was conducted by NONIN® Medical, Incorporated as described below.

SpO2 Accuracy Testing 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 sensors is compared to arterial hemoglobin oxygen (SaO2) value, determined from blood samples with a laboratory co-oximeter. The accuracy of the sensors 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 9919:2005, 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 module must maintain accuracy in accordance with ISO 9919:2005 for pulse rate and SpO2 at the lowest obtainable pulse amplitude (0.3% modulation).

Specifications Oxygen Saturation Display Range:

0% to 100% SpO2

Pulse Rate Display Range:

18 to 321 beats per minute (bpm)

Oxygen Saturation Declared Accuracy Range: (Arms*):

70% to 100% SpO2 ±2 digits

Low Perfusion Oxygen Saturation Declared Accuracy Range (Arms*):

70-100% SpO2 ±2 digits

Pulse Rate Declared Accuracy Range (Arms*):

20-250 BPM ±3 digits

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

40-240 ±3 digits

Measurement Wavelengths and Output Power**: Red: Infrared:

660 nanometers @ 0.8 mw maximum average 910 nanometers @ 1.2 mw maximum average

Temperature (Operating):

+32° to +104°F / 0° to +40°C

Temperature (Storage/Transportation): Humidity (Operating): Humidity (Storage/Transportation): Altitude (Operating): (Hyperbaric Pressure): Battery Life (Continuous): Battery Life (Storage): Classifications per IEC 60601-1 / CSA 601.1/ UL 60601-1: Degree of Protection:

-22° to +122°F / -30° to +50°C 10% to 90% non-condensing 10% to 95% non-condensing Up to 40,000 feet / 12,192 meters Up to 4 atmospheres Approximately 2,500 spot checks based on ~21 hours of operation using two AAA-size alkaline batteries, calculated at 30 seconds per spot check. 4 years, minimum Type BF-Applied Part

Enclosure Degree of Ingress Protection:

IPX2

Mode of Operation:

Continuous

This product complies with ISO 10993-1. *± 1 Arms represents approximately 68% of measurements. **This information is especially useful for clinicians performing photodynamic therapy.

Warranty

NONIN® MEDICAL, INCORPORATED, (NONIN®) warrants to the purchaser, for a period of two years from the date of purchase, each Onyx® exclusive of the batteries, spring, carrying case, lanyard, and lanyard lock. 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. 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®.

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 61000-3-3

N/A

This device is suitable for use in all establishments, including domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Voltage Fluctuations/Flicker Emissions IEC 61000-3-3

N/A

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 ±8 kV air

Floors should be wood, concrete, or 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 ±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.

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

3 A/m

3 A/m

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

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

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 150 kHz to 80 MHz

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

N/A

d = 1.17 P

[3] V/m

d = 1.17 P

80 MHz to 800 MHz 800 MHz to 2.5 GHz

d = 3.50 P

[2] V/m 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 [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.

Table 4: Recommended Separation Distances The following table details the recommended separation distances between portable and mobile RF communications equipment and this device. 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

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 = 3.50 P

0.01

0.12

0.12

0.35

0.1

0.37

0.37

1.11

1

1.2

1.2

3.5

10

3.7

3.7

11.1

100

12

12

35

W

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.

NONIN® Medical, Inc. 13700 1st Avenue North Plymouth, MN 55441-5443 USA

+1 (763) 553-9968 800-356-8874 (US and Canada) Fax +1 (763) 553-7807 E-mail: [email protected] www.nonin.com

EC

REP

Authorized EC Representative: MPS, Medical Product Service GmbH Borngasse 20 D-35619 Braunfels, Germany

©2008 5104-001-04