Nonin Connect 3230 - Smart Pulse Oximeter Instructions For Use

Indications for Use

The NoninConnect Model 3230 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.

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.

Clinical Benefits

Nonin pulse oximeters allow for the management of patients' medical conditions by providing fast, accurate, real-time, noninvasive oxygen measurement in order to meet patients' medical needs.

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.
• Use the Model 3230 within its designated range (approximately 10 m/32 ft, spherical radius, line of sight when connected to a Bluetooth Smart Ready device). Moving outside this range may cause missing, lost, and/or inaccurate data.
• Inspect the sensor application site at least every 4 hours to ensure correct sensor alignment and skin integrity. Patient sensitivity to sensor may vary due to medical status or skin condition.
• Avoid excessive pressure to the sensor application site as this may cause damage to the skin beneath the sensor.
• This device is intended only as an adjunct in patient assessment. It must be used in conjunction with other methods of assessing clinical signs and symptoms.
• The device must be able to measure the pulse properly to obtain an accurate SpO₂ measurement. Verify that nothing is hindering the pulse measurement before relying on the SpO₂ measurement.
• Operation of this device below the minimum amplitude of 0.3% modulation may cause inaccurate results.
• General operation of the device may be affected by the use of an electrosurgical unit (ESU).
• Keep the oximeter away from young children. Small items such as the battery door and battery are choking hazards.
• Before changing batteries, make sure the device is off and is not applied to a digit.
• Portable RF communications equipment such as cell phones or radios (including peripherals such as antenna cables and external antennas) should be used no closer than 30cm (12 inches) to any part of the ME system, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

• This device has no audible alarms and is intended only for spot-checking.
• This device is designed to determine the percentage of arterial oxygen saturation of functional hemoglobin. Factors that may degrade pulse oximeter performance or affect the accuracy of the measurement include the following:
  • applying the pulse oximeter on the same arm as a blood pressure cuff, arterial catheter or infusion line(s) (IVs)
  • finger is outside recommended size range
  • methemoglobin
  • dysfunctional hemoglobin
  • poor pulse quality
  • artificial nails or fingernail polish
  • venous pulsations
  • residue (e.g., dried blood, dirt, grease, oil) in the light path
  • excessive light, such as sunlight or direct home lighting
  • cardiogreen and other intravascular dyes
  • excessive motion
  • anemia or low hemoglobin concentrations
  • moisture in the device
  • improperly applied device
  • carboxyhemoglobin
• The device may not work when circulation is reduced. Warm or rub the finger, or re-position the device.
• The device is designed to be attached only to a digit.
• This device's display will shut off after 30 seconds of no readings or poor readings.
• In some circumstances, the device will interpret motion as good pulse quality. Minimize patient motion as much as possible.
• Clean the device before applying it to a new patient.
• Do not sterilize, autoclave, or immerse this device in liquid. Do not pour or spray any liquids into the device.
• Do not use caustic or abrasive cleaning agents, or any cleaning products containing ammonium chloride or isopropyl alcohol.
• Do not use cleaning solutions other than those recommended here, as permanent damage could result.
• This device 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.
• This equipment complies with 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 medical installation. However, because of the proliferation of radio-frequency transmitting equipment and other sources of electrical noise in health care and 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. Medical electrical equipment needs special precautions regarding EMC, and all equipment must be installed and put into service according to the EMC information specified in this manual.
• When device is connected via Bluetooth, other Wi-Fi devices within 6 meters (20 feet) could interrupt the Bluetooth connection.
• Portable and mobile RF communications equipment including CT, diathermy, RFID, and electronic article security systems can affect medical electrical equipment.
• 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. Do not mix fully charged and partially charged batteries at the same time. These actions may cause the batteries to leak.
• Follow local, state, and national governing ordinances and recycling instructions regarding disposal or recycling of the device and device components, including batteries.
• In compliance with the European Directive on Waste Electrical and Electronic Equipment (WEEE) 2002/96/EC, do not dispose of this product as unsorted municipal waste. This device contains WEEE materials; please contact your distributor regarding take-back or recycling of the device. If you are unsure how to reach your distributor, please call Nonin for your distributor's contact information.

Symbols

Symbol	Definition
	Caution!
	Follow Instructions for Use.
	Medical Device
	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.
	Non-ionizing electromagnetic radiation. Equipment includes RF transmitters. Interference may occur in the vicinity of equipment marked with this symbol.
	Date of Manufacture
	Continua Certified™ signifies this device meets Continua certification testing requirements, which support interoperability in personal health devices (continuaalliance.org).
	Indicates separate collection for electrical and electronic equipment (WEEE)
	Not for continuous monitoring (no alarm for SpO 2 )
	Battery orientation
	Importer
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
	Unique Identifier
	Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner.
	Country of Manufacture
	Manufacturer
	Authorized Representative in the European Community
	Catalogue number
	Quantity

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.

Display Symbols

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 3230 is unable to detect a usable signal.
	White symbol – Radio is on. Green symbol – 3230 is connected. Flashing symbol – Connection error. The radio will reset. No symbol – Radio is off.
	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.
	† Spot-check complete. While Spot-check is in progress, a clockwise spinning circular icon displays.
	† Measurement complete (full screen).

† These indicators only display when the associated feature has been activated by an integrator.

Using the NoninConnect Model 3230

Installing AAA Batteries

Use only alkaline batteries. When batteries are low, displays. Replace low batteries as soon as possible.

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

1. Hold the 3230 so you see the back of the device and the arrows on the battery door point away from you.
   
2. Place your thumbs on the ovals.
   
3. Slide the battery door away from you and off the 3230.
   
4. If applicable, remove the old batteries from the 3230. Properly dispose of the batteries.
5. Insert two new 1.5 volt AAA size batteries. Carefully match the polarity markings (+ and -). The 3230 will not work if the batteries are inserted the wrong way.
   
6. Carefully slide the battery door back onto the device.
   

Turning On the NoninConnect Model 3230

1. Insert a digit into the Model 3230 until it touches the built-in stop.
   
   NOTE: Make sure the finger is centered within the finger guide and flat (not on its side). For best results, keep the device at heart or chest level.
2. If the CorrectCheck screen (see Display Symbols table) displays, slide finger further into device. Correct positioning of the finger is critical for accurate measurements.
3. The 3230 begins sensing the pulse and displaying readings.
   
4. View about 4 seconds of readings before relying on the displayed values. Continually verify operation. It is common for the displayed values to vary slightly over a period of several seconds. If the 3230 does not turn on or if it shuts off unexpectedly:
   • Verify batteries are correctly inserted.
   • The batteries are depleted. Replace batteries.
     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.

Connection via Bluetooth Wireless Technology

When the Model 3230 is placed on the finger and turns on, it is ready for a Bluetooth wireless connection. The 3230 stays in this mode until it is shut off or the Bluetooth radio turns off. The symbol is white when the Bluetooth radio is on, green when the 3230 is connected, and flashes 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 3230 and the host device must be tested before using the 3230's Bluetooth capabilities.

Turning Off the NoninConnect Model 3230

The Model 3230 will automatically turn off approximately 10 seconds after the digit is removed, or after a 2-minute period of poor signals.

Cleaning the NoninConnect Model 3230

• Clean the device before applying it to a new patient.
• Do not sterilize, autoclave, or immerse this device in liquid. Do not pour or spray any liquids into the device.
• Do not use caustic or abrasive cleaning agents, or any cleaning products containing ammonium chloride or isopropyl alcohol.
• Do not use cleaning solutions other than those recommended here, as permanent damage could result.

1. To clean, wipe the device's surfaces with a soft cloth dampened with one of the following:
   • A 10% bleach solution (household bleach [5.25% sodium hypochlorite]).
   • Warm, soapy water (hand dishwashing detergent – see note below), and then rinse the cleaned surfaces with a soft cloth dampened with water (home use only).
2. Dry with a soft cloth, or allow to air dry. Ensure that all surfaces are completely dry.

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.

Warranty

For warranty information please refer to: http://www.nonin.com/warranty.

All non-warranty work shall be done at Nonin's standard rates and charges in effect at the time of delivery to Nonin. All repairs include a complete restest of the Nonin 3230 using factory test fixtures.

Users and/or patients should report adverse events involving their Nonin device to Nonin Medical, Inc.

Nonin Medical, Inc.
13700 1st Avenue North
Plymouth, Minnesota 55441, USA

(800) 356-8874 (USA/Canada)
+1 (763) 553-9968 (outside USA and Canada)
E-mail: technicalservice@nonin.com

Nonin Medical B.V.
Doctor Paul Janssenweg 150
5026 RH Tilburg, Netherlands

+31 (0)13 - 45 87 130 (Europe)
E-mail: technicalserviceintl@nonin.com

nonin.com

Specifications

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 A_rms values measured using the Model 3230 in a clinical study.

NOTE: If your national regulatory authority recognizes accuracy in motion, please contact regulatory@nonin.com for accuracy data.

Accuracy Summary – Finger and Thumb

This graph shows plots of the error (SpO₂ – SaO₂) by SaO₂ using the 3230 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.

SpO₂ Low Perfusion Accuracy (A_rms)*: 70 to 100% ±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

Temperature:
Operating: -5°C to 40°C / 23°F to 104°F
Storage/Transportation: -40°C to 70°C / -40°F to 158°F
Time (from storage) for device to be ready for its intended use:
3 minutes to warm from -40°C to -5°C
8 minutes to cool from 70°C to 40°C

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 A_rms represents approximately 68% of measurements at zero bias.

** This information is especially useful for clinicians performing photodynamic therapy.

Bluetooth Wireless Technology Information

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 3230

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: 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. Bluetooth SIG Standard: Compliant with Bluetooth SIG Pulse Oximeter Profile specifications adopted by Continua.

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. If the connection is lost, the device will become available for a connection in a few seconds.

Bluetooth Profiles Supported: GATT-based Nonin Proprietary Oximeter Profile; GATT-based Bluetooth SIG Pulse Oximeter Profile

Authentication and Encryption: Supported

Encryption Key Size: 128 bits AES (advanced encryption standard)

Bluetooth Security

The Bluetooth radio contained in the 3230 is a Bluetooth Smart single-mode, low-energy radio. The 3230 supports an encryption key size of 128 bits. While the 3230 is in a Bluetooth connection, it will be unavailable for other connections. Apart from the standard Bluetooth security measures, Nonin has two non-standard security measures that are available.

For additional technical information, please see the insert, "NoninConnect Model 3230 Technical Description."

Portable RF communications equipment such as cell phones or radios (including peripherals such as antenna cables and external antennas) should be used no closer than 30cm (12 inches) to any part of the ME system, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

Manufacturer's Declaration

Refer to the following tables for specific information regarding this device's compliance to 60601-1-2. Component compliance level is determined by system compliance level.

Essential Performance

Essential performance of the 3230 is defined as SpO₂ accuracy and pulse rate accuracy or an indication of abnormal operation. Accuracies may be affected as a result of exposure to electromagnetic disturbances that are outside of the environments listed in the Indications For Use. If issues are experienced, move the Nonin system away from the source of electromagnetic disturbances.

Table 1: Electromagnetic Emissions

Table 2: Electromagnetic Immunity

Table 3: Not Applicable