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Before changing back of the device and the batteries, make sure the device is arrows on the battery door point away from you. off and is not applied to a digit.
If the device does not turn on or if it shuts off unexpectedly:
If the problem persists, remove the batteries and contact Nonin Technical Service.
NOTE: While on the finger, do not press the device against any surface and do not squeeze or hold it together. The internal spring provides the correct pressure; additional pressure may cause inaccurate readings.
The NoninConnect Elite Model 3240 Finger Pulse Oximeter is a small, lightweight, portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate of patients who are well or poorly perfused. It is intended for spot-checking of adult and pediatric patients with digits between 0.8 – 2.5 cm (0.3 – 1.0 inch) thick.
Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner.
NOTE: Use Environment—Home healthcare environments under the supervision of qualified medical professionals. Users include current/potential users of pulse oximetry in the home and caregivers/potential caregivers of such a user.
Do not use the device in an MR environment, in an explosive atmosphere, or on neonatal patients.
Symbol | Definition |
Caution! | |
Follow Instructions for Use. | |
Consult Instructions for Use. | |
MR unsafe | |
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. | |
Radio Equipment Class Identifier | |
Non-ionizing electromagnetic radiation. Equipment includes RF transmitters. Interference may occur in the vicinity of equipment marked with this symbol. | |
Indicates separate collection for electrical and electronic equipment (WEEE) | |
Date of Manufacture | |
Medical Device | |
Catalogue number | |
Symbol | Definition |
Not for continuous monitoring (no alarm for SpO2) | |
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 |
BDA | Bluetooth Device Address |
Storage/shipping temperature range | |
Handle with Care | |
Keep Dry | |
RCM Australia | |
Medical prescription required | |
Manufacturer | |
Authorized Representative in the European Community | |
Importer | |
Unique Device Identifier | |
Country of Manufacture |
Oxygen Saturation Display Range: 0% to 100% SpO2
Pulse Rate Display Range: 18 to 321 beats per minute (BPM)
Declared Accuracy*: The table below shows Arms values measured using the Model 3240 in a clinical study.
NOTE: If your national regulatory authority recognizes accuracy in motion, please contact regulatory@nonin.com for accuracy data.
Range | Specified Oxygen Saturation (Arms) | Finger Oxygen Saturation (Arms) | Thumb Oxygen Saturation (Arms) | Low Perfusion Oxygen Saturation (Arms) |
70 – 100% | ± 2 | ± 1.31 | ± 1.56 | ± 2 |
70 – 80% | ± 2 | ± 1.65 | ± 1.91 | ± 2 |
80 – 90% | ± 2 | ± 1.05 | ± 1.21 | ± 2 |
90 – 100% | ± 2 | ± 1.18 | ± 1.49 | ± 2 |
This graph shows plots of the error (SpO2 – SaO2 ) by SaO2 using the 3240 with a linear regression fit and upper 95% and lower 95% limits of agreement. Each sample data point is identified by subject from a clinical study in non-motion conditions.
Pulse Rate Declared Accuracy Range (Arms)*:
20 to 250 BPM ±3 digits
Low Perfusion Pulse Rate Declared Accuracy Range (Arms)*: 4
0 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
Temperature:
Operating. -5°C to 40°C / 23°F to 104°F
Storage/Transportation. -40°C to 70°C / -40°F to 158°F
Humidity:
Operating. 10% to 95% non-condensing
Storage/Transportation. 10% to 95% non-condensing
Altitude:
Operating. Up to 4,000 meters / 13,123 feet
Hyperbaric Pressure. Up to 4 atmospheres
Battery Life:
Operating. Approximately 2,200 spot checks (25 sec. per spot-check), within 10 meters/32 feet of collector with streaming data
Storage. 1 month, with batteries installed.
Remove batteries if the device will be stored for more than 30 days.
* ±1 Arms represents approximately 68% of measurements.
** This information is especially useful for clinicians performing photodynamic therapy.
Bluetooth Compliance: | Version 4.0 single mode low energy |
Operating Frequency: | 2.4 to 2.4835 GHz |
Output Power: | TX: +3 dBM |
Operating Range: | 10 meter radius (line of sight) |
Network Topology: | Star - bus |
Operation: | Slave Model 3240 |
Antenna Type: | Integrated chip type antenna |
Modulation Type: | Frequency Hopping Spread Spectrum |
Data Rate: | 1 Mbit/second |
Data Latency: | 6 ms |
Data Integrity: | Adaptive Frequency Hopping 24-bit CRC (cyclic redundancy check) 32-bit message integrity check |
Data Format: | 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. |
Quality of Service: | This device uses Bluetooth Smart technology for wireless communications, which allows for reliable communications in electrically noisy environments, and transmits physiological data once per second. If data is lost, the device will transmit data again one second later. If the connection is lost, the device will change the Bluetooth symbol from green to white and become available for a connection in a few seconds. |
Bluetooth Profiles Supported: | GATT-based proprietary Nonin profile |
Authentication and Encryption: | Supported |
Encryption Key Size: | 128 bits AES (advanced encryption standard) |
The Bluetooth radio contained in the 3240 is a Bluetooth Smart single-mode, low-energy radio. It supports a GATT-based, proprietary Nonin profile to transmit current readings from the patient. Data is not stored by the 3240 to be transferred at a later time. The 3240 supports an encryption key size of 128 bits. While the 3240 is in a Bluetooth connection, it will be unavailable for other connections. Apart from the standard Bluetooth security measures, Nonin has implemented a non-standard security measure to the 3240 that, if used, will restrict the transfer of data to only devices with a specified organizationally unique identifier (OUI).
For additional technical information, please see the insert, "NoninConnect Elite Model 3240 Technical Description."
NOTE: Where applicable, an additional label bearing your country radio communications license information will appear on the side of your device. This is not a serial number or device identifier.
Symbol | Description |
Nonin's CorrectCheck™ senses that the finger has not been correctly inserted. If you see this symbol, slide finger further into device. | |
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 3240 is unable to detect a usable signal. | |
White symbol – Radio is on. Green symbol – 3240 is connected. Flashing white symbol – Connection error. The radio will reset. | |
Poor signal. Steady your hand, reposition finger, warm finger by rubbing, or select a different finger. | |
Low battery. Replace batteries. | |
Critical battery. Flashing indicator on full screen. The device will not work until the batteries are replaced. |
Use only alkaline batteries. When batteries are low, displays. Replace low batteries as soon as possible. See the "Installing AAA Batteries" instructions and figures at left.
See the "Turning on the NoninConnect Elite Model 3240" instructions and figures at left.
When the Model 3240 is placed on the finger and turns on, it is ready for a Bluetooth wireless connection. The 3240 stays in this mode until it is shut off. The symbol is white when the Bluetooth radio is on, green when the 3240 is connected, and flashes white when there is a communication error.
The Bluetooth symbol is useful for the product installer.
Due to the wide variety of wireless environments, the Bluetooth connection between the 3240 and the host device must be tested before using the 3240's Bluetooth capabilities.
The Model 3240 will automatically turn off approximately 10 seconds after the digit is removed, or after a 2-minute period of poor signals.
NOTE: The hand dishwashing detergent that was tested includes these ingredients: Sodium Lauryl Sulfate, Sodium Laureth Sulfate, Lauramine Oxide, Sodium Chloride, PPG-26, PEG-8 Propylheptyl Ether, and Phenoxyethanol.
NONIN MEDICAL, INCORPORATED, (Nonin) warrants to the purchaser, for a period of 2 years from the date of purchase, each Model 3240 exclusive of the batteries and spring. The device's expected service life is 5 years.
Nonin shall repair or replace any 3240 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. If unable to repair, Nonin shall replace with a 3240 or a comparable device. This warranty shall be the sole and exclusive remedy by the purchaser hereunder for any 3240 delivered to the purchaser which is found to be defective in any manner whether such remedies be in contract, tort or by law.
This warranty excludes cost of delivery to and from Nonin. All repaired units shall be received by the purchaser at Nonin's place of business. Nonin reserves the right to charge a fee for a warranty repair request on any 3240 found to be within specifications.
Model 3240 is a precision electronic instrument and must be repaired by trained Nonin personnel only. Any sign or evidence of opening the 3240, field service by non-Nonin personnel, tampering, or any kind of misuse of the 3240, shall void the warranty. All non-warranty work shall be done at Nonin's standard rates and charges in effect at the time of delivery to Nonin.
Users and/or patients should report adverse events involving their Nonin device to Nonin Medical, Inc. and the competent authority of the EU Member State in which the user and/or patient is established, if applicable.
Nonin Medical, Inc. 13700 1st Avenue North Plymouth, Minnesota 55441-5443 USA (800) 356-8874 (USA/Canada) +1 (763) 553-9968 (outside USA and Canada) | Nonin Medical B.V. Doctor Paul Janssenweg 150 5026 RH Tilburg, Netherlands +31 (0)13 - 45 87 130 (Europe) E-mail: technicalserviceintl@nonin.com |
E-mail: technicalservice@nonin.com
nonin.com
Here you can download full pdf version of manual, it may contain additional safety instructions, warranty information, FCC rules, etc.
Download Nonin Connect Elite 3240 - Bluetooth Smart Pulse Oximeter Manual
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