Nonin TruO2 OTC Instructions For Use

TruO2 OTC
Model 3250 Instructions for Use
Indications for Use
The Nonin Medical 3250 Finger Pulse Oximeter is a small, portable device indicated for use
in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO
pulse rate of individuals who are well or poorly perfused under no motion conditions for medical
use without a prescription. It is intended for spot-checking of individuals 18 years and older with
finger thickness between 0.8-2.5 cm (0.3-1.0 inch). It is not intended for the diagnosis or
screening of lung disease, for use in treatment decisions, and should only be used for making
healthcare decisions under the advice of a healthcare provider.
Clinical Benefits
Nonin pulse oximeters provide fast, accurate, real-time, professional grade noninvasive oxygen
measurement for individuals who are well or poorly perfused, with all skin colors, and under no
motion conditions for medical use without a prescription. It is intended for spot-checking of
individuals 18 years and older with finger thickness between 0.8-2.5 cm (0.3-1.0 inch).
The Monk Scale shows the range of all skin colors. Additional performance information is
included in the Operator's Manual (see QR code).
Specifications
*Additional specifications are available in the Operator's Manual that can be located using the
QR Code on the front cover.
Accuracy
)*: 70 to 100% ±2 digits.
• SpO Low Perfusion Accuracy (A
2 rms
)*: 20 to 250 BPM ±3 digits.
• Pulse Rate Declared Accuracy Range (A
rms
• Low Perfusion Pulse Rate Declared Accuracy Range (A
rms
• Clinical studies have shown that the device's accuracy is not affected by differences in
skin pigmentation.
Operating Conditions
• Temperatures no lower or higher than -5°C to 40°C
(23°F to 104°F).
• Humidity no lower or higher than 10 to 95%.
Battery Life
• Approximately 2,200 uses or stored for 1 month.
• If stored for more than 30 days, remove the batteries.
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P/N 114718-001-03 11/2024 13700 1st Avenue North, Plymouth, MN 55441-5443 USA
Warnings
• SpO provides an estimate of oxygen levels in the blood but should always be used together with other health information
2
• When using the Bluetooth® connection, keep the device within 10 meters (32 feet) of the connected device. Moving outside
this range may cause missing and/or loss of data to the connected device.
• Avoid excessive pressure to the application site as this may cause damage to the skin and/or cause inaccurate readings.
• Keep the device away from young children. Small items such as the battery door and batteries are choking hazards.
• Do not use the device in a Magnetic Resonance (MR) setting or in an explosive area.
• Do not use the device when defibrillation is applied.
• Skin sensitivity to the device may vary based on your medical status or skin condition.
• Do not only rely on this device for determining your health status. This device is to be used in combination with other
) and
methods to properly determine your health status. Contact your healthcare provider for medical advice as needed.
2
• Before changing the batteries, make sure the device is not on a finger and is turned off.
• Always inspect the device before use. Do not use a damaged device. If the device is damaged or has unacceptable
deterioration (e.g. cracking, corrosion, discoloration), discontinue use immediately.
• Self-monitoring does not mean diagnosis or treatment. Unusual values must always be discussed with your healthcare
provider. Under no circumstances should you independently alter oxygen delivery settings or medical treatment prescribed
by your healthcare provider.
• Pulse oximeter measurements can vary depending on age and medical history.
• Normal resting SpO
for individuals with lung disease, advanced age, or those living in high altitude. Please consult with your healthcare provider
to define your normal values. You should be aware of your normal (baseline) SpO
meaningful.
• A pulse oximeter measurement should be interpreted while considering other signs and symptoms and health history.
Otherwise, the measurement may be misleading. You should also focus on the change from your baseline level over time
and not solely on a single measurement at any given time.
• Focusing solely on a pulse oximeter measurement may give a false sense of security. This is because in some cases one
may have lung problems before you have trouble breathing. It can also show normal measurements while you could be
struggling to breathe. Seek medical attention if you are not feeling well even if your reading is normal.
NOTE: Be aware of the many factors listed in the Limitations section that can limit or lower this device's accuracy.
Limitations - Device Accuracy
Some things can limit or decrease the device's accuracy. Examples of such things may include:
• Simultaneous use of a blood pressure cuff on the same arm.
• Direct exposure of the device to sunlight or home lighting while in use.
• Movement, including tremors, of the hand or finger on which the device is being used.
• Moisture or wetness in the device.
• Placing the device on a toe instead of a finger.
• A fingertip that is thinner or thicker than 0.8 – 2.5 cm (or 0.3 – 1.0 inch).
• Nail polish or fake/glued-on fingernails.
• A weak/poor pulse or an irregular heartbeat.
• Use of the device after recently receiving dyes used for medical imaging of heart-function.
• Use of the device on a person with a blood disorder such as anemia.
• Use of the device when blood circulation is lower than usual (e.g., when hands are cold). In such a case, warm or rub
hands/finger before using the device.
• Skin pigmentation at low oxygen saturation levels (less than 80%).
• Carbon monoxide.
• Smoking and smoke inhalation.
)*: 40 to 240 BPM ±3 digits.
Cautions
• This device has no alarms and is not meant for continuous monitoring (monitoring for a long period of time).
• Keep the device away from flammables, sources of fire, or direct heat.
Accuracy Summary
• The device is designed to be attached to one finger at a time.
SaO Measured Accuracy • This device will shut off after 30 seconds of poor or no readings.
2
• In some circumstances, motion will affect the accuracy of the device. Minimize motion during use as much as possible.
(A )
• Clean the device promptly after each use to prevent dirt from drying on the device.
rms
• Do not drop the device in liquid. Do not pour or spray any liquids directly onto the device.
70-100% 2.27
• Use only recommended cleaning solutions, as permanent damage could happen.
• Do not heat-sterilize the device.
70-80% 2.85
• Device repairs must be done by a qualified technical professional. Do not attempt to open the case or repair the device as
it may cause damage and void the warranty.
80-90% 1.86
• When the device is connected via Bluetooth, other Wi-Fi devices within 6 meters (20 feet) could interrupt the
Bluetooth connection.
1.97
90-100%
• Batteries may leak or explode if used or disposed of improperly. Remove batteries if the device will be stored for more
than 30 days. Do not use different types of batteries at the same time. Use only alkaline batteries. Do not use 1 new and 1
old battery at the same time. These actions may cause the batteries to leak.
• Follow local, state, and national rules regarding disposal or recycling of the device and device components,
including batteries.
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levels are typically 95% or greater. This can vary from person to person. Normal values can be lower
2
levels for the device's reading to be most
2
U.S. Patents 10,624,583; D718,455.
Bluetooth is a registered trademark of Bluetooth SIG, Inc.
All trademarks are the property of Nonin Medical, Inc. unless otherwise noted.
TruO2 ® OTC
Model 3250 Instructions for Use
Thank you for trusting Nonin with your healthcare needs.
We sincerely appreciate your business. Please read this document carefully
and direct any further questions to a Nonin Technical Service representative.
More information can be found using this QR code.
https://www.nonin.com/support/truo2-otc
For summary of safety and clinical data see above QR code.
Please refer to the Operator' s Manual on nonin.com/support/truo2-otc
for troubleshooting guidance and more detailed operating instructions.
Contact Customer Service or Technical Service
Toll Free: 800.356.8874
(U.S. and Canada only)
Phone: +1 763.553.9968
Email: customerservice@nonin.com
Have other questions or want to learn more?
Visit nonin.com to read more about our history, product offerings, and more.
Warranty
Symbol
The device warranty
Glossary
is 2 years.
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P/N 114718-001-03 11/2024 13700 1st Avenue North, Plymouth, MN 55441-5443 USA
MR MR
Nonin Medical Inc.
13700 1st Avenue North
Plymouth, MN 55441-5443, USA
Compliance
This product complies
with ISO 10993.
Not made from
natural rubber latex.
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