Nonin G02 ARCHIEVE User Manual

User Guide

i

Table of Contents

Introduction ....................................................................................................1

Contents of Package

.......................................................................................1

Symbols ..........................................................................................................2

Intended Use ...................................................................................................4

Installing the Battery.......................................................................................8

Applying the GO

2

Achieve to Your Finger .....................................................10

Activating the Device ....................................................................................12

Verifying Operation ....................................................................................... 12

Reading Your Results ....................................................................................13

Care and Maintenance ..................................................................................15

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Troubleshooting ............................................................................................ 16

Parts and Accessories ...................................................................................19

Specifications ................................................................................................20

Equipment Response Time ............................................................................23

Testing Summary ..........................................................................................24

SpO2 Accuracy Testing ...............................................................................24

Low Perfusion Testing ................................................................................24

Warranty .......................................................................................................25

1

Introduction

Thank you for buying the GO2 Achieve 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 GO2 Achieve is easy to use and needs no
routine maintenance except battery replacement. This User Guide explains how to use and
care for your GO2 Achieve.

Contents of Package

• GO2 Achieve

• One AAA Alkaline Battery

• User Guide

• Quick Guide

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The following symbols are associated with your GO2 Achieve.

Symbol Definition of Symbol

Consult Instructions for Use

Follow 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)

C

L

A

S

S

I

F

I

E

D

US

C

U

L

UL Mark for Canada and the United States with respect to electric shock, fire, and
mechanical hazards only in accordance with:

- ANSI/AAMI ES60601-1:2005/(R)2012 and CAN/CSA-C22.2 No. 60601-1:14

- ISO 80601-2-61:2011 and IEC 60601-1-11:2015

Symbols

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Symbol Definition of Symbol

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

Temperature Limitation for storage/shipping

Keep dry.

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Intended Use

GO2 Achieve 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 – 2.5 cm) 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.

• Before changing batteries, make sure the GO2 Achieve is off and is not applied to a
digit.

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Cautions

• The GO2 Achieve might misinterpret excessive movement as good pulse strength. Limit
finger movement as much as possible when using the device.

• The GO2 Achieve 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 Achieve 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 Achieve 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 GO2 Achieve:

– 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.

!

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• The GO2 Achieve may not work if you have poor circulation. Rub your finger to
increase circulation, or place the device on another finger.

• The GO2 Achieve 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 Achieve will be stored for more than 30 days.

• Do not use the GO2 Achieve in a combustible environment (oxygen enriched
environment).

• Do not use the GO2 Achieve outside the specified operating and storage temperature
ranges.

• Do not use the GO2 Achieve for more than 30 minutes without relocating the device
to another finger.

• The GO2 Achieve 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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• When using the GO2 Achieve in the home, avoid exposing the GO2 Achieve to lint and
dust.

• 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 Achieve and its components,
including the battery.

• The GO2 Achieve is a precision electronic instrument and must be repaired by Nonin
Technical Service.

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Installing the Battery

One 1.5 volt AAA-size (LR03) battery powers the GO2 Achieve for approximately 2400
measurements. Nonin recommends using alkaline batteries (one is included with each
new GO2 Achieve). 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 Achieve 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

9

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.

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Applying the GO2 Achieve to Your Finger

Hold the GO2 Achieve with the display
facing toward you; slide your finger into
the opening at the bottom of the device, as
shown at right, until the fingertip touches
the built-in stop guide. The index (pointer)
finger is recommended.

Have your forearm parallel to the floor when
you use the GO2 Achieve. Make sure your
finger is centered within the finger guide
and the GO2 Achieve is at heart or chest
level.

GO

2

% SpO

2

11

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

GO

2

% SpO

2

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Activating the Device

The GO2 Achieve automatically turns on when a finger
is inserted. When a finger is inserted, the GO2 Achieve
performs a brief self test, as shown at right. Verify that
all segments of the LCD (Liquid Crystal Display) appear
during the startup sequence.’

Verifying Operation

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

If the GO2 Achieve does not turn on or if it shuts off
unexpectedly, remove the GO2 Achieve from your finger,
remove the battery, and see the Troubleshooting section.
Continually verify operation.

GO

2

% SpO

2

13

Reading Your Results

When you put your finger in the GO2 Achieve, 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 GO2 Achieve 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

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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.

Pulse Quality Indicator

Percent Oxygen Saturation

Pulse Rate

Battery Indicator

Sensor Disconnect Indicator

= full capacity

= half capacity

= near empty, replace

(flashing) = empty, replace

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Care and Maintenance

The GO2 Achieve 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 GO2 Achieve 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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Troubleshooting

Problems Possible Cause Possible Solution

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.

Display blank Finger not properly

inserted.

Reposition finger to activate
the device.

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Troubleshooting

Problems Possible Cause Possible Solution

Display blank Battery. Verify battery is correctly

inserted. Note: If battery is
installed backwards, the unit
will not function.

Dead battery. Replace battery.

If the problem persists, remove
the battery and contact Nonin

Technical Service.

Device may be too cold
to operate.

Allow device to sit at room
temperature for at least
10 minutes.

Missing segments
on LCD display.

Faulty display. Contact Nonin Technical

Service.

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Troubleshooting

Problems Possible Cause Possible Solution

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.

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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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Specifications

Oxygen Saturation Display Range 0% to 100%

Pulse Rate Display Range 18 to 321 beats per minute (BPM)

Oxygen Saturation Declared
Accuracy Range (A

rms

*) 70% to 100% SpO2 ± 2 digits

Low Perfusion Oxygen Saturation
Declared Accuracy Range (A

rms

*) 70% to 100% SpO2 ± 2 digits

Pulse Rate Declared Accuracy Range (A

rms

*) 20 to 250 BPM ± 3 digits

Low Perfusion Pulse Rate
Declared Accuracy Range (A

rms

*) 40 to 240 BPM ± 3 digits

Measurement Wavelengths and Output Power

Red 660 nanometers @ 0.8 mW Max. Average

Infrared 910 nanometers @ 1.2 mW Max. Average

*± 1 A

rms

represents approximately 68% of measurements.

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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)

Time (from storage) for monitor to be ready for its intended use:

7 minutes to warm from -30 °C to 5 °C
12 minutes to cool from 70 °C to 40 °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 13,123 feet /4,000 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

This product is not made with natural rubber latex.

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Classifications per ANSI/AAMI ES60601-1 and CAN/CSA-C22.2 No. 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 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 radio­frequency 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

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

SaO2 Reference

4 Beat Average

Time in seconds

SpO

2

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

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Testing Summary

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

SpO2 Accuracy Testing

During no-motion conditions at an independent research laboratory, SpO2 accuracy testing is conducted
during induced hypoxia studies on healthy, male and female, non-smoking, light- to dark-skinned subjects
that are 18 years of age and older. 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 80601-2-61 and ISO 9919, Medical Electrical Equipment–Particular requirements for the
basic safety and essential performance of pulse oximeter equipment for medical use.

Low Perfusion Testing

This test uses a SpO2 Simulator to provide a simulated pulse rate, with adjustable amplitude settings at
various SpO

2

levels for the oximeter to read. The oximeter must maintain accuracy in accordance with

ISO 80601-2-61 and ISO 9919 for heart rate and SpO

2

at the lowest obtainable pulse amplitude (0.3%

modulation).

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Warranty

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

2

Achieve 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. Nonin reserves the right to replace the device with a suitable
alternative.

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 Achieve found to be within
specifications. GO2 Achieve is a precision electronic instrument and must be repaired by
Nonin Technical Service. Any sign or evidence of opening the GO

2

Achieve, field service by
non-Nonin personnel, tampering, or any kind of misuse of the GO2 Achieve, shall void the
warranty. The GO2 Achieve 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.

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Nonin Medical, Inc.

13700 1st Avenue North

Plymouth, MN 55441-5443

[phone]
[phone]

web site: www.nonin.com

e-mail: [e-mail]

MPS, Medical Product Service GmbH

Borngasse 20

D-35619 Braunfels, Germany

©2016 Nonin Medical, Inc.

7077-000-06

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 GO

2

Achieve.

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

!

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.