6963-101-1
© 2019 Nonin Medical, Inc.
MPS, Medical Product Service GmbH
Borngasse 20
D-35619 Braunfels, Germany
Nonin Medical, Inc.
13700 1st
Plymouth, MN 55441, USA
Phone: +1 (763) 553-9968
(800) 356-8874 (US and Canada)
+31 (0)13 - 79 99 040 (Europe)
E-mail: info@nonin.com
infointl@nonin.com (Europe)
www
Indications for Use
The GO
2
Model 9570 is intended to measure blood oxygen saturation (%SpO
2
) (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. Contact your licensed health care professional for your expected oxygen saturation level (to compare with your readings).
The GO
2
Model 9570 is intended for Home Health Care only.
W
• 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.
• Avoid excessive pressure to the sensor application site as this may cause damage to the skin beneath the sensor.
• Before changing batteries, make sure the device is off and is not applied to a digit.
Cautions
• Do not use the device in an MR environment, in an explosive atmosphere, or on neonatal patients.
• This device is not defibrillation proof per IEC 60601-1.
• Do not use the GO
2
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.
• The GO
2
might misinterpret excessive movement as good pulse strength. Limit finger movement as much as possible when using the device.
• The GO
2
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 GO
2
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 sterilze, autoclave, or place the GO
2
in liquid or clean it with agents containing ammonium chloride, or products that are not listed in this
instruction. Do not pour or spray any liquids onto the GO
2
.
• The GO
2
is not intended for use in institutions.
•
Any of the following conditions may reduce the performance of the GO
:
• The GO
2
may not work if you have poor circulation. Rub your finger to increase circulation, or place the device on another finger.
• The GO
2
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 GO
2
will be stored for more than 30 days.
• Do not use the GO
2
in a combustible environment (oxygen enriched environment).
• Do not use the GO
2
outside the specified operating and storage temperature ranges.
• Do not use the GO
2
for more than 30 minutes without relocating the device to another finger.
• The GO
2
needs to be used according to information provided in this instruction.
• Do not tamper with, or hang lanyard from the flexible circuit.
• When using the GO
2
in the home, avoid exposing the GO
2
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 GO
2
and its components, including the battery.
• The GO
2
is a precision electronic instrument and must be repaired by Nonin Technical Service. Field repair of the device is not possible. Do not
attempt to open the case or repair the electronics. Opening the case may damage the device and void the warranty.
Symbols
Display Symbols
Using the Model 9570 GO
2
Activating the Device:
The GO
2
automatically turns on when a finger is inserted. When a finger is inserted, the GO
2
performs a brief self
test (Figure D ). Verify that all segments of the LCD (Liquid Crystal Display) appear during the startup sequence. If any part of the screen is
not lit, do not use the device; contact Nonin Technical Service for repair or replacement.
V
The GO
2
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 device does not turn on or if it shuts off unexpectedly:
• Verify batteries are correctly inserted.
• The batteries are depleted. Replace batteries.
Continually verify operation. If the problem persists remove the batteries and contact Nonin Technical Service.
The Oxitest
Plus7
by Datrend Systems, Inc. can be used to verify operation of the pulse oximeter.
Reading Y
When you put your finger in the GO
2
, you’ll notice an LCD display come on (Figure E ). The numbers you see
show:
• the amount of oxygen in your blood, displayed as %SpO
2
; 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 GO
2
is formulating its reading immediately after activating the device, the inadequate signal indicator ( ) will appear. The inadequate
signal 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
“Display Symbols” table). Replace the battery when this symbol begins to flash.
TGO
2
9570:
The GO
2
will automatically turn off approximately 10 seconds after the digit is removed, or after a 2-
minute period of poor signals.
Care and Maintenance
The GO
2
requires no calibration or periodic maintenance other than battery replacement. The device’s expected service life is 2 years.
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.
Do not sterilize, autoclave, or place the GO
2
in liquid or clean it with agents containing ammonium chloride, or products that are not listed
in this instruction. Do not pour or spray any liquids onto the GO
2
.
Specifications
Oxygen Saturation Display Range:
0% to 100%
Pulse Rate Display Range:
18 to 321 beats per minute (BPM)
Oxygen Saturation Declared
A
rms
*
)
:
70% to 100% SpO2 ±2 digits
Low Perfusion Oxygen Saturation Declared
A
rms
*
)
:
70% to 100% SpO2 ±2 digits
Pulse Rate Declared
A
rms
*
)
:
20 to 250 BPM±3 digits
Low Perfusion Pulse Rate Declared
rms
*):
40 to 240 BPM ±3 digits
Measurement W
Red: 660 nanometers @ 0.8 mW Max. average
Infrared: 910 nanometers @ 1.2 mW Max. average
T
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
NOTE: 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:
Operating: Up to 4,000 meters / 13,123 feet
Battery Life:
Continuous: Approximately 2,400 spot checks based on ~21 hours of operation using one AAA-size alkaline
battery, calculated at 30 seconds per use.
Storage: 6 months minimum
Classifications per
Operating: 41 °F to 104 °F (5 °C to 40 °C)
Storage/Transportation: -22 °F to 158 °F (-30 °C to 70 °C)
Enclosure Degree of
Ingress Protection: IP33
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 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, Biographical evaluation of medical devices - Part1: Evaluation and testing.
*±1 A
rms
represents approximately 68% of measurements.
**This information is especially useful for clinicians performing photodynamic therapy.
This device is not made with natural latex.
Principles of Operation
Pulse oximetry is a non-invasive method that passes red and infrared light through perfused tissue and detects the fluctuating signals caused by
arterial pulses. Well-oxygenated blood is bright red, while poorly oxygenated blood is dark red. The pulse oximeter determines functional oxygen
saturation of arterial hemoglobin (SpO
2
) from this color difference by measuring the ratio of absorbed red and infrared light as volume
fluctuates with each pulse.
Equipment Response T
If the signal from the sensor is inadequate, the last measured SpO
2
and pulse rate values freeze for ten seconds and are then replaced with dashes.
Example: SpO
2
Exponential Averaging
SpO
2
decreases 0.75% per second; pulse rate = 75 BPM
The response of the 4-beat average is 1.5 seconds.
T
SpO
2
accuracy and low perfusion testing were conducted by Nonin Medical, Inc., as described below:
SpO2 Accuracy
During no-motion conditions at an independent research laboratory, SpO
2
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 (SpO
2
) of the sensors is compared to arterial hemoglobin
oxygen (SaO
2
) 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 SpO
2
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 T
This test uses a SpO
2
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).
W
Nonin warrants to the purchaser, for 2 years from the date of purchase, each GO
2
Model 9570 exclusive of the battery. Nonin will repair or
replace any GO
2
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. 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
GO
2
Model 9570 found to be within specifications. GO
2
Model 9570 is a precision electronic instrument and must be repaired by Nonin
Technical Service. Any sign or evidence of opening the GO
2
Model 9570, field service by non-Nonin personnel, tampering, or any kind of
misuse of the GO
2
Model 9570, shall void the warranty. The GO
2
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
www.nonin.com
Manufacturer
Refer to the following table for specific information regarding this device’s compliance to IEC 60601-1-2.
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects, and people.
• 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.
Symbol Definition
Caution!
Follow Instructions for Use.
Type BF Applied Part (patient isolation from electrical shock)
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.
CE Marking indicating conformance to EC Directive No. 93/42/EEC concerning medical devices.
EC
REP
Authorized Representative in the European Community
Temperature Limitation for storage/shipping
Inadequate signal; the pulse signal is not detected or there is excessive motion.
Indicates separate collection for electrical and electronic equipment (WEEE)
Not for continuous monitoring (no alarm for SpO
2
)
Battery orientation
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.) in diameter per IEC 60529.
SN
Serial Number
Medical prescription required
Symbol Description
The number next to this symbol is the amount of oxygen in your blood (functional oxygen saturation of arterial
hemoglobin).
The number next to this animated symbol is your pulse rate. Pulse rate is the number of times your heart beats per
minute.
– – –
Dashes replace the readings when the GO
2
is unable to detect a usable signal.
Inadequate signal. Steady your hand, reposition finger, warm finger by rubbing, or select a different finger.
Full capacity
Half capacity
Near empty capacity, replace.
(Flashing) Empty capacity, replace.
SpO2 V A Latency
Standard/Fast Averages SpO2 4-beat Exponential 2 beats
Pulse Rate V A Latency
Standard/Fast Averages SpO2 4-beat Exponential 2 beats
Equipment Delays Delay
Standard/Fast Averages SpO2 1.5 seconds
Electromagnetic Emissions
Emissions T 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 environement.
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
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.
Electromagnetic Immunity
Immunity T Compliance Electromagnetic Environment-Guidance
Electrostatic Discharge
(ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic
material, relative himidty should be at least 30%.
Power Frequency (50/60
Hz)
Magnetic Field
IEC 61000-4-8
30 A/m
Power frequency magnetic fields should be at levels characteristic of a typical location in a
typical commercial or hosipital environment.
Electromagnetic Immunity
Immunity T Compliance Electromagnetic Environment-Guidance
Radiated RF
IEC 61000-4-3
10 V/m
Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part of the 9570.
Otherwie, degradation of the performance of this equipment could result.
Not Applicable
IEC 61000-3-2, IEC 61000-3-3, IEC 61000-4-4, IEC 61000-4-5, IEC 61000-4-11, IEC 61000-4-6
Nonin Medical, Inc.
13700 1st Avenue North
Plymouth, Minnesota 55441 USA
(800) 356-8874 (USA/Canada)
+1 (763) 553-9968 (outside USA and
Canada)
Fax: +1 (763) 553-7807
E-mail: technicalservice@nonin.com
Nonin Medical B.V.
Prins Hendriklaan 26
1075 BD Amsterdam, Netherlands
+31 (0)13 - 79 99 040 (Europe)
Fax: +31 (0)13 - 79 99 042
E-mail: technicalserviceintl@nonin.com
Installing the
Use only alkaline batteries. One 1.5 volt AAA-size (LR03)
battery powers the GO
2
for approximately 2400 measurements.
1. Remove the battery door located on the left side of the GO
2
by sliding it towards you.
2. Insert one new 1.5 volt AAA-size battery (Figure A ). Follow the plus (+) and minus
(-) markings for battery direction (as shown inside of the battery compartment).
3. Carefully reposition the battery door (Figure B ).
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 GO
2
to Y
Hold the GO
2
with the display facing toward you;
slide your finger into the opening at the bottom of the device, until the fingertip touches
the built-in stop guide (Figure C ). The index (pointer) finger is recommended.
Have your forearm parallel to the floor when you use the GO
2
. Make sure your finger is
centered within the finger guide and the GO
2
is at heart or chest level.
NOTE: Correct positioning of the device on your finger is critical for
accurate measurements. While on the finger, do not press the GO
2
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
% SpO
2
% SpO
2
Instructions for Use - English
GO
2
Model 9570 Fingertip Pulse Oximeter
