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Summary of Contents for Nonin TruO2 3250
- Page 1 Operator’s Manual Model 3250 ® TruO2 OTC Pulse Oximeter English...
- Page 2 Phone: 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. 115500-001-01 11/2024 ©2024 Nonin Medical, Inc. U.S. Patents 10,624,583; D718,455. Bluetooth is a registered trademark of Bluetooth SIG, Inc.
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Page 3: Table Of Contents
Contents Glossary ............................3 Displays and Indicators ....................... 4 Indications for Use ........................5 Clinical Benefits ........................... 5 Warnings ............................6 Limitations - Device Accuracy ..................... 7 Cautions............................7 Installing Batteries ........................8 Using the Device .......................... 9 Cleaning Instructions ......................... 10 How to know if the device is clean? .................. -
Page 4: Glossary
Glossary Accuracy How close the displayed value is to the true value. The value that represents accuracy (Accuracy Root Mean Square). Arterial Oxygen Saturation (SaO Percentage of oxygen measured in blood circulating in arteries. Bias How much the displayed value is expected to shift from the true value. -
Page 5: Displays And Indicators
Symbols Displays and Indicators Nonin’s CorrectCheck™ senses that the finger has not been correctly inserted. The number next to this symbol is the amount of oxygen measured in the blood (functional oxygen saturation of arterial hemoglobin). The number next to this animated symbol is the measured pulse rate. -
Page 6: Indications 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 and pulse rate of individuals who are well or poorly perfused under no motion conditions for medical use without a prescription. -
Page 7: Warnings
Warnings provides an estimate of oxygen levels in the blood but should always be used together with other health information. 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. -
Page 8: Limitations - Device 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. -
Page 9: Installing Batteries
To set up and use the TruO2 OTC (Model 3250) pulse oximeter, please follow the simple instructions below. Installing Batteries 1. Hold the device so the back is facing up and the arrows on the battery door point away from you. 2. -
Page 10: Using The Device
3. The device begins sensing the pulse and displaying readings. 4. If the device does not turn on or if it shuts off unexpectedly: • Check batteries are installed correctly. • Replace batteries. • If the problem persists, remove the batteries, and contact Nonin Technical Service. -
Page 11: Cleaning Instructions
Cleaning Instructions To avoid damaging the device, follow the warnings, cautions, and cleaning instructions as described. Gently wipe the display screen with a soft, clean, dry cloth. 1. Clean all other surfaces of the device with a soft, clean cloth that is lightly dampened with warm, soapy water (use liquid dish soap) for general cleaning. - Page 12 Table 1. Table 2. Accuracy of 3250 Device Bias Accuracy Summary Range Measured Skin Pigmentation 70-85% 85-100% Accuracy (A Light 0.98 70 – 100% 2.27 Medium 1.14 0.43 70 – 80% 2.85 Dark 2.57 1.08 80 – 90% 1.86 Bias: The table above shows the Bias values measured during 90 –...
- Page 13 Figure 2. This graph is a representation of Figure 1 broken down by skin pigmentation. Figure 3. This graph is a representation of Figure 1 broken down by gender.
- Page 14 These graphs (Figures 4-8) show the Oxygen Saturation (SpO ) versus the Co-Oximeter (SaO utilized in a clinical study. Each point is a measurement for a subject and the diagonal line represents SpO and SaO being equal. Ideally, points should be randomly scattered about the diagonal line with no apparent trends.
- Page 15 Figure 6. This graph is a representation of dark skin pigmentation. Figure 7. This graph is a representation of females. Figure 8. This graph is a representation of males.
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Page 16: Testing Summary
Testing Summary Accuracy Testing accuracy testing was conducted during studies on healthy, male and female, non- smoking, light, medium, and dark-skinned subjects that were 18 years of age and older. The values determined from blood samples. measured SpO of the device was compared to SaO The accuracy of the device was compared to the blood samples measured over the SpO range of 70 –... -
Page 17: Connecting Via Bluetooth® Wireless Technology
32-bit: message integrity check security measures, Nonin has two non-standard security measures that are available. Data Format: Nonin Proprietary: Sends data packets once per second. Includes a second counter that allows the host to detect if packets are missing and the device to retransmit. -
Page 18: Electromagnetic Emissions
Table 3. Table 4. Electromagnetic Emissions Electromagnetic Immunity This device is intended for use in the Immunity Test Compliance home healthcare environment. The user of this device should ensure that it is Electrostatic Discharge ±8kV contact used in such an environment. (ESD) ±15 kV air IEC 61000-4-2... -
Page 19: Warranty
If the device is defective during the warranty period, please contact Nonin Medical (https://www.nonin.com/technical-support). If Nonin Medical determines that the device is defective, it will be repaired or replaced with the same or similar model, free of charge, during the warranty period.
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