Nonin GO2 Achieve User manual

User Guide
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Introduction....................................................................................................1
Contents of Package.......................................................................................1
Symbols ..........................................................................................................2
Intended Use...................................................................................................4
Installing the Battery.......................................................................................8
Applying the GO2Achieve to Your Finger ......................................................10
Activating the Device and Verifying Operation..............................................12
Reading Your Results ....................................................................................13
Care and Maintenance..................................................................................15
Specifications................................................................................................20
Equipment Response Time ............................................................................23
Testing Summary ..........................................................................................24
SpO2Accuracy Testing ...........................................................................24
Pulse Rate Motion Testing ......................................................................24
Low Perfusion Testing.............................................................................24
Warranty.......................................................................................................25
Table of Contents
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Introduction
Thank you for buying the GO2Achieve 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 GO2Achieve is easy to use and needs no
routine maintenance except battery replacement. This User Guide explains how to use and
care for your GO2Achieve.
Contents of Package
 • GO2Achieve
 • One AAA Alkaline Battery
 • User Guide
 • Quick Guide
Symbols
The following symbols are associated with your GO2Achieve.
Symbol Definition of Symbol
Consult Instructions for Use
! Caution!
0123
CE Marking: conformance to EC Directive No. 93/42/EEC for medical devices
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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Battery
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
Temperature Limitation for storage/shipping
Intended Use
GO2Achieve 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.
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.
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Cautions
• The GO2Achieve might misinterpret excessive movement as good pulse strength. Limit
finger movement as much as possible when using the device.
• The GO2Achieve 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 GO2Achieve 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 GO2Achieve in liquid or clean it with agents containing ammonium
chloride, isopropyl alcohol, or products that are not listed in this User’s Guide.
• Any of the following conditions may reduce the performance of the GO2Achieve:
– flickering or very bright light;
– weak pulse quality (low perfusion);
– low hemoglobin;
– arterial catheters;
– nail polish, and/or artificial nails; and
– any tests recently performed on you that required an injection of intravascular dyes.
• The GO2Achieve may not work if you have poor circulation. Rub your finger to
increase circulation, or place the device on another finger.
• The GO2Achieve 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 GO2Achieve will be stored for more than 30 days.
• Do not use the GO2Achieve in a combustible environment (oxygen enriched
environment).
• Do not use the GO2Achieve outside the specified operating and storage temperature
ranges.
• Do not use the GO2Achieve for more than 30 minutes without relocating the device
to another finger.
• The GO2Achieve needs to be used according to information provided in the User
Guide.
• Do not tamper with, or hang lanyard from the flexible circuit.
!
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• Radios and cell phones or similar devices may affect the GO2Achieve and should be kept
at least 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 GO2Achieve and its components,
including the battery.
• The GO2Achieve is a precision electronic instrument and must be repaired by Nonin
Technical Service.
Installing the Battery
One 1.5 volt AAA-size (LR03) battery powers the GO2Achieve for approximately 2400
measurements. Nonin recommends using alkaline batteries (one is included with
each new GO2Achieve). 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 GO2Achieve 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).
GO
2
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3. Carefully reposition the battery door. NOTE: Do not force it into place; it fits only
when positioned correctly.
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.
Applying the GO2Achieve to Your Finger
Hold the GO2Achieve 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.
For best results, make sure the finger is centered within the finger guide; keep the
GO2Achieve at heart or chest level. The index (pointer) finger is recommended.
GO
2
%SpO
2
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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 GO2Achieve against any surface and do not squeeze
or hold it together. The internal spring provides the correct pressure; additional pressure may
cause inaccurate readings.
Activating the Device and Verifying Operation
The GO2Achieve automatically turns on when a finger is inserted. When a finger is
inserted, the GO2Achieve performs a brief self test, as shown below. Verify that all
segments of the LCD (Liquid Crystal Display) appear during the startup sequence.
The GO2Achieve LCD has an integrated backlight that turns on automatically in low light
conditions. This allows the display to be visible in dark spaces.
GO
2
%SpO
2
GO
2
%SpO
2
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Reading Your Results
When you put your finger in the GO2Achieve, you’ll notice an LCD display come on.
The numbers you see show:
 • 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 GO2Achieve is calculating 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
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.
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
Pulse Quality Indicator
Percent Oxygen Saturation
Pulse Rate
Battery Indicator
Sensor Disconnect Indicator
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Care and Maintenance
The GO2Achieve 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.
Caution: Do not place the GO2Achieve in liquid or clean it with agents containing
ammonium chloride, isopropyl alcohol, or products that are not listed in this User’s Guide.
Problems Possible Cause Possible Solutions
Troubleshooting
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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Problems Possible Cause Possible Solutions
Problems Possible Cause Possible Solutions
Troubleshooting
Display blank Nothing appears on
the display.
Reposition finger to activate
the device.
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.
Troubleshooting
Missing segments
on LCD display.
No readings
Faulty display.
Low pulse quality
(no reading).
Contact Nonin Technical
Service.
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.
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Specifications
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
Measurement Wavelengths and Output Power
Red 660 nanometers @ 0.8mW
Max Average
Infrared 910 nanometers @ 1.2mW
Max Average
*± 1 Arms represents approximately 68% of measurements.
Parts and Accessories
GO2CC Black neoprene carrying case with belt loop
GO2L Black 20” lanyard
GO2R Clip on retractable holder
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 [phone] (USA and Canada) or [phone].
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Temperature (Operating) +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 AAA-
size alkaline battery, calculated
at 30 seconds per use.
Battery Life (Storage) 6 months minimum
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
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.
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Equipment Response Time Testing Summary
SpO2accuracy and low perfusion testing were conducted by Nonin Medical, Inc., as described below:
SpO2Accuracy Testing
SpO2accuracy testing is conducted during induced hypoxia studies on healthy, non-smoking, light- to dark-
skinned 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 SpO2range 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.
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.
Low Perfusion Testing
This test uses a SpO2Simulator to provide a simulated pulse rate, with adjustable amplitude settings at various
SpO2levels for the oximeter to read. The oximeter must maintain accuracy in accordance with ISO 9919:2005
for heart rate and SpO2at the lowest obtainable pulse amplitude (0.3% modulation).
100
95
90
85
80
75
70
65
60
0.0 8.0 16.0 24.0 32.0 40.0 48.0 56.0 64.0 72.0 80.0
SaO2Reference 4 Beat Average
Time in seconds
SpO2
Specific to this example: The response of the 4-beat average is 1.5 seconds.
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Warranty
Nonin warrants to the purchaser, for 2 years from the date of purchase, each GO2Achieve
exclusive of the battery. Nonin will repair or replace any GO2Achieve 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 excludes cost of delivery to and from Nonin. Nonin reserves the right
to charge a fee for a warranty repair request on any GO2Achieve found to be within
specifications. GO2Achieve is a precision electronic instrument and must be repaired by
Nonin Technical Service. Any sign or evidence of opening the GO2Achieve, field service by
non-Nonin personnel, tampering, or any kind of misuse of the GO2Achieve, shall void the
warranty. The GO2Achieve is warranted for consumer 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.
Nonin Medical, Inc.
13700 1st Avenue North
Plymouth, MN 55441-5443
[phone]
[phone]
web site: www.nonin.com
e-mail: [email protected]
Authorized EC Representative:
MPS, Medical Product Service GmbH
Borngasse 20
D-35619 Braunfels, Germany
©2009 Nonin Medical, Inc.
7077-000-02
EC
REP
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Please take a moment to find and record the 9-digit serial number found on the back of your GO2Achieve.
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 [phone].
My Serial Number: _________________________________________________
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GO
2
1. www.go2nonin.com
+70°C
-30°C 0123 !
GO
2
%SpO
2
GO
2
%SpO
2
2.
Warning: Keep away from small children; this device contains small parts that may pose a choking hazard.
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