GO2 Model 9570 User Guide 6963-001-03

Introduction

Contents of Package • GO2 Model 9570 • One AAA Alkaline Battery

Symbols

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Thank you for buying the GO2 Model 9570 Fingertip Pulse Oximeter. This small, portable device will give you important information about your oxygen saturation (the amount of oxygen in your blood) and pulse rate at your fingertip! The Model 9570 is easy to use and needs no routine maintenance except battery replacement. This User Guide explains how to use and care for your GO2 Model 9570.

The following symbols are associated with your GO2 Model 9570. Symbol

Definition of Symbol Consult Instructions for Use Caution!

! 0123

CE Marking: conformance to EC Directive No. 93/42/EEC for medical devices

• User Guide • Quick Guide

Type BF Applied Part (patient isolation from electrical shock). Not for Continuous Monitoring (no alarm for SpO2) UL Mark for Canada and the United States with respect to electric shock, fire, and mechanical hazards only in accordance with IEC 60601-1, UL 60601-1 and CAN/CSA-C22.2 No. 601.1.

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Intended Use

Indicates separate collection for electrical and electronic equipment (WEEE).

IP33

Protected against spraying water and against access to hazardous parts with a tool, per IEC 60529.

SN

Serial Number Sensor disconnect; the pulse signal is not detected or there is excessive motion.

EC

REP

Authorized Representative in the European Community

+70°C

-30°C

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GO2 Model 9570 is intended to measure blood oxygen saturation (%SpO2) (the amount of oxygen in your blood) and pulse rate of both adults and children. It is designed for fingers (not the thumb) between 0.3 and 1.0 inch (0.8 – 2.5cm) thick. The index finger (pointer finger) is most recommended. Contact your licensed health care professional for your expected oxygen saturation level (to compare with your readings). The GO2 Model 9570 is intended for Home Health Care Only.

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Battery

Contraindications • Do not use the GO2 in a magnetic resonance (MR) environment. Warnings • 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 the lanyard should become wrapped around your neck. Use the lanyard with caution.

Temperature Limitation for storage/shipping

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- low hemoglobin;

• Do not use the GO2 as the only basis for making medical decisions. It is intended only to be used as additional information that you can give to your licensed health care professional.

- arterial catheters;

• The GO2 might misinterpret excessive movement as good pulse strength. Limit finger movement as much as possible when using the device. • The GO2 must be able to measure your pulse properly to give you an accurate reading. Do not put the device on the same hand/arm when using a blood pressure cuff or monitor. • The GO2 has no alarms. It will not sound if the amount of oxygen in your blood is low or if your pulse rate is too high or too low. • Do not place the GO2 in liquid or clean it with agents containing ammonium chloride, isopropyl alcohol, or products that are not listed in this User’s Guide. • The GO2 is not intended for use in institutions. • Any of the following conditions may reduce the performance of the GO2: - flickering or very bright light; - weak pulse quality (low perfusion); 5 6963-001-03 ENG.indd 5-6

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Cautions

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- nail polish, and/or artificial nails; and - any tests recently performed on you that required an injection of intravascular dyes. • The GO2 may not work if you have poor circulation. Rub your finger to increase circulation, or place the device on another finger. • The GO2 measures oxygen saturation of functional hemoglobin. High levels of dysfunctional hemoglobin (caused by sickle cell anemia, carbon monoxide, etc.) could affect the accuracy of the measurements. • Batteries can leak or explode if used or disposed of improperly. Remove the battery if the GO2 will be stored for more than 30 days. • Do not use the GO2 in a combustible environment (oxygen enriched environment). • Do not use the GO2 outside the specified operating and storage temperature ranges. • Do not use the GO2 for more than 30 minutes without relocating the device to another finger.

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• Radios and cell phones or similar devices may affect the GO2 and should be kept at least 2 meters (7 feet) away from the device. • 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 towers and TV broadcast towers may affect accuracy. • Use in emergency vehicles with communication systems may affect accuracy. • Functional tester cannot be used to assess the accuracy of this pulse oximeter. • Follow local disposal and recycling laws for the GO2 and its components, including the battery. • The GO2 is a precision electronic instrument and must be repaired by Nonin Technical Service.

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• Do not tamper with, or hang lanyard from the flexible circuit.

Installing the Battery One 1.5 volt AAA-size (LR03) battery powers the GO2 for approximately 2400 measurements. Nonin recommends using alkaline batteries (one is included with each new GO2). NOTE: You may use rechargeable batteries; however, they may require more frequent replacement. 1. Remove the battery door located on the left side of the GO2 by sliding it towards you. 2. Insert one new 1.5 volt AAA-size battery. Follow the plus (+) and minus (-) markings for battery direction (as shown inside of the battery compartment).

GO2

• The GO2 needs to be used according to information provided in the User Guide.

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Applying the GO2 Model 9570 to Your Finger Hold the GO2 with the display facing toward you; slide your finger into the opening at the bottom of the device, as shown below, until the fingertip touches the built-in stop guide.

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3. Carefully reposition the battery door. NOTE: Do not force it into place; it fits only when positioned correctly.

For best results, make sure the finger is centered within the finger guide; keep the GO2 at heart or chest level. The index (pointer) finger is recommended.

% Sp

O2

GO

2

When battery is low, the battery indicator symbol on the display will flash. Remove battery if the device will be stored for more than 30 days. Replace low battery as soon as possible.

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Activating the Device and Verifying Operation The GO2 automatically turns on when a finger is inserted. When a finger is inserted, the GO2 performs a brief self test, as shown below. Verify that all segments of the LCD (Liquid Crystal Display) appear during the startup sequence.

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NOTE: Correct positioning of the device on your finger is critical for accurate measurements. While on the finger, do not press the GO2 against any surface and do not squeeze or hold it together. The internal spring provides the correct pressure; additional pressure may cause inaccurate readings.

% SpO

2

% SpO2

GO2

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GO2

The GO2 LCD has an integrated backlight that turns on automatically in low light conditions. This allows the display to be visible in dark spaces.

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Reading Your Results

Percent Oxygen Saturation

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When you put your finger in the GO2 , you’ll notice an LCD display come on. The numbers you see show:

excessive motion. If this symbol does not turn off while your finger is in the device, reposition your finger or switch to a different finger. Pulse Quality Indicator

• the amount of oxygen in your blood, displayed as %SpO2; and • your Pulse Rate, displayed as a 2 or 3 digit number, measuring the number of times your heart beats per minute. The Pulse Quality indicator ( ) displays the strength of the pulse rate signal. Bars will display after the , indicating pulse signal strength ( ); the greater the number of bars indicates a greater pulse quality signal strength. If you are not getting a pulse rate reading and your pulse quality indicator is weak, warm the finger or reposition to another finger. While the GO2 is formulating its reading immediately after activating the device, the sensor disconnect indicator ( ) will appear. The sensor disconnect indicator also appears when you remove your finger to indicate the pulse signal is not detected or when there is 13 6963-001-03 ENG.indd 13-14

Sensor Disconnect Indicator Pulse Rate Battery Indicator

The Battery indicator symbol shows the battery strength (the less the symbol is filled – the less battery capacity is available – see chart below). Replace the battery when this symbol begins to flash. = full capacity = half capacity = near empty, replace (flashing) = empty, replace

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Care and Maintenance

Caution: Do not place the GO2 in liquid or clean it with agents containing ammonium chloride, isopropyl alcohol, or products that are not listed in this User’s Guide. !

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The GO2 requires no calibration or periodic maintenance other than battery replacement. Wipe the device with a soft cloth dampened with a mild detergent or 10% bleach solution. Do not use undiluted bleach or any cleaning solution other than those recommended here, as permanent damage could result. Dry with a soft cloth, or allow to air dry. Clean once per week or more frequently if handled by multiple users.

Troubleshooting Problems

Possible Cause

Possible Solutions

Display Lockup

Display does not appear to change (you should see a change to the pulse indicator if the device is on the finger).

Reposition finger or change fingers. Remove and replace battery. If the problem persists contact Nonin Technical Service.

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Troubleshooting

Display blank

Possible Cause

Nothing appears on the display.

Possible Solutions

Problems

Possible Cause

Possible Solutions

Reposition finger to activate the device.

Missing segments on LCD display.

Faulty display.

Contact Nonin Technical Service.

Verify battery is correctly inserted. Note: If battery is installed backwards, the unit will not function. Dead battery. Replace battery. May be too cold. Allow device to sit at room temperature for at least 30 minutes. If the problem persists contact Nonin Technical Service.

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Problems

Troubleshooting

No readings

Low pulse quality (no reading).

If the indicator is visible and the pulse quality bar graph does not show more than 2 bars, try the following: 1. Reposition finger. 2. Warm finger by rubbing. 3. Select a different finger. For more information, please see Reading Your Results. 18 11/18/2009 4:12:42 PM

Parts and Accessories

GO2L

GO2R

Black neoprene carrying case with belt loop

Black 20” lanyard

Clip on retractable holder

Oxygen Saturation Display Range

0% to 100%

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% to 100% SpO2 ± 2 digits

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

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GO2CC

Specifications

Measurement Wavelengths and Output Power WARNING: Certain activities may pose a risk of injury, including strangulation, if the lanyard should become wrapped around your neck. Use the lanyard with caution. For more information about Nonin parts and accessories, contact your distributor, or contact Nonin at (877) 577-2635 (USA and Canada) or (763) 553-9968. 19 6963-001-03 ENG.indd 19-20

Red

660 nanometers @ 0.8mW Max Average

Infrared

910 nanometers @ 1.2mW Max Average

*± 1 Arms represents approximately 68% of measurements.

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+41°F to +104°F (5°C to +40°C)

Storage/Transportation

-22°F to +158°F (-30°C to +70°C)

Device temperature will not exceed 41°C as measured during a controlled environment test. Humidity (Operating)

10% to 90% relative humidity, non-condensing

Storage/Transportation

10% to 95% relative humidity, non-condensing

Operating Altitude

Up to 40,000 feet /12,192 meters

Battery Life (Continuous)

Approximately 2400 spot checks based on ~21 hours of operation using one AAAsize alkaline battery, calculated at 30 seconds per use.

Battery Life (Storage)

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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

IP33

Mode of Operation

Continuous

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Temperature (Operating)

This equipment complies with International Standard IEC 60601-1-2:2004 for electromagnetic compatibility for medical electrical equipment and/or systems. This standard is designed to provide reasonable protection against harmful interference in a typical installation. However, because of the proliferation of radio-frequency transmitting equipment and other sources of electrical noise in health care, home, and many 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. This product complies with ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing.

6 months minimum

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Equipment Response Time

Testing Summary 4 Beat Average

SpO2 Accuracy Testing SpO2 accuracy testing is conducted during induced hypoxia studies on healthy, non-smoking, light- to darkskinned subjects during motion and no-motion conditions 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 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, Medical Electrical Equipment–Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use.

100 95 90

SpO2

85 80

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SaO2 Reference

SpO2 accuracy and low perfusion testing were conducted by Nonin Medical, Inc., as described below:

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 9919:2005 for pulse rate during simulated movement, tremor, and spike motions.

75 70

Low Perfusion Testing This test uses a SpO2 Simulator to provide a simulated pulse rate, with adjustable amplitude settings at various SpO2 levels for the oximeter to read. The oximeter must maintain accuracy in accordance with ISO 9919:2005 for heart rate and SpO2 at the lowest obtainable pulse amplitude (0.3% modulation).

65 60 80.0

72.0

64.0

56.0

48.0

40.0

32.0

24.0

16.0

8.0

0.0

Time in seconds 23 6963-001-03 ENG.indd 23-24

Specific to this example: The response of the 4-beat average is 1.5 seconds.

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Warranty Nonin Medical, Inc. 13700 1st Avenue North Plymouth, MN 55441-5443

This warranty excludes cost of delivery to and from Nonin. Nonin reserves the right to charge a fee for a warranty repair request on any GO2 Model 9570 found to be within specifications. GO2 Model 9570 is a precision electronic instrument and must be repaired by Nonin Technical Service. Any sign or evidence of opening the GO2 Model 9570, field service by non-Nonin personnel, tampering, or any kind of misuse of the GO2 Model 9570, shall void the warranty. The GO2 Model 9570 is warranted for Home Health Care Use Only. All non-warranty work shall be done at Nonin’s standard rates and charges in effect at the time of delivery to Nonin.

web site: www.nonin.com e-mail: [email protected]

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Nonin warrants to the purchaser, for 2 years from the date of purchase, each GO2 Model 9570 exclusive of the battery. Nonin will repair or replace any GO2 Model 9570 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.

(763) 553-9968 (877) 577-2635

EC

REP

Authorized EC Representative: MPS, Medical Product Service GmbH Borngasse 20 D-35619 Braunfels, Germany ©2009 Nonin Medical, Inc. 6963-001-03

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Please take a moment to find and record the 9-digit serial number found on the back of your GO2 Model 9570. You’ll need this number if you have to contact Nonin with technical service issues or if you have any questions regarding the use or performance of your pulse oximeter. Nonin’s technical service department can be reached at (877) 577-2635.

My Serial Number: _________________________________________________

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1.

2.

2

% SpO

-30°C

2

GO

+70°C 0123

GO2

2

% SpO

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Warning: Keep away from small children; this device contains small parts that may pose a choking hazard.

www.go2nonin.com

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GO2