Nonin NoninConnect Elite 3240 User manual

11038-001-05 03/2022
© 2022 Nonin Medical, Inc.
Nonin Medical, Inc.
13700 1st Avenue North
Plymouth, MN 55441, USA
www.nonin.com
E-mail: [e-mail]
[phone]
[phone] (US and Canada)
Fax: [phone]
Nonin Medical B.V.
Doctor Paul Janssenweg 150
5026 RH Tilburg, Netherlands
Email: [e-mail] (Europe)
+31 (0)13 - 45 87 130 (Europe)
Nonin, NoninConnect Elite, and CorrectCheck are trademarks of Nonin Medical, Inc.
U.S. Patents 5,490,523; 5,792,052; other patents pending.
The Bluetooth® word mark and logo are registered trademarks owned by Bluetooth SIG, Inc.
Installing AAA Batteries
WARNING: Before changing
batteries, make sure the device is
off and is not applied to a digit.
1. Hold the 3240 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 3240.
4. If applicable, remove the
old batteries from the 3240.
Properly dispose of the
batteries.
5. Insert two new 1.5 volt AAA-
size batteries. Carefully match
the polarity markings (+ and -).
The 3240 will not work if the
batteries are inserted the
wrong way.
6. Carefully slide the battery door
back onto the device.
NONINCONNECT ELITE MODEL 3240
NONIN MEDICAL, INC.
PLYMOUTH, MN USA
IP32
NONINCONNECT ELITE MODEL 3240
NONIN MEDICAL, INC.
PLYMOUTH, MN USA
IP32
Turning On the NoninConnect
Elite Model 3240
1. Insert a digit into the Model 3240
until it touches the built-in stop.
NOTE: Make sure the finger is lying
flat (not on its side) and is centered
within the device. 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 3240 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 device 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.
Instructions for Use – English
NoninConnect Elite™ Model 3240
Bluetooth®Smart Pulse Oximeter
Indications for Use
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.
CAUTION: 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.
Contraindications
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.
Warnings
• Use the Model 3240 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 6 to 8 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.
Cautions
• This device has no audible alarms and is intended only for spot-checking.
•
T his 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
followi ng:
• 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 qualified technical professionals. 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.
• Portable and mobile RF communications equipment including CT, diathermy, RFID, and electronic article
security systems can affect medical electrical equipment.
• When device is connected via Bluetooth, other Wi-Fi devices within 6 meters (20 feet) could interrupt the
Bluetooth connection.
• 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
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
Using the NoninConnect Elite Model 3240
Installing AAA Batteries
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.
Turning On the NoninConnect Elite Model 3240
See the “Turning on the NoninConnect Elite Model 3240” instructions and figures at left.
Connection via Bluetooth Wireless Technology
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.
Turning Off the NoninConnect Elite Model 3240
The Model 3240 will automatically turn off approximately 10 seconds after the digit is removed, or after a 2-minute
period of poor signals.
Cleaning the NoninConnect Elite Model 3240
CAUTIONS:
!
• 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
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-warran
ty work shall be done at Nonin’s standard rates and charges in effect at the time
of delivery to Nonin.
www.nonin.com/warranty
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.
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 Arms values measured using the Model 3240 in a
clinical study.
NOTE: If your national regulatory authority recognizes accuracy in motion, please contact
[e-mail] for accuracy data.
Pulse Rate Declared Accuracy Range (Arms)*: 20 to 250 BPM ±3 digits
Low Perfusion Pulse Rate Declared Accuracy Range (Arms)*: 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
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. CAUTION: 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 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 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)
Bluetooth Security
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.”
Symbol Definition Symbol Definition
!
Caution! Not for continuous monitoring (no
alarm for SpO2)
Follow Instructions for Use. Battery orientation
Consult Instructions for Use.
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.
MRMR
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.
SN Serial Number
BDA Bluetooth Device Address
Storage/shipping temperature range
CE Marking indicating conformance to
EC Directive No. 93/42/EEC
concerning medical devices.
Handle with Care
Keep Dry
Radio Equipment Class Identifier RCM Australia
Non-ionizing electromagnetic radiation.
Equipment includes RF transmitters.
Interference may occur in the vicinity of
equipment marked with this symbol.
Medical prescription required
Manufacturer
Indicates separate collection for electrical
and electronic equipment (WEEE)
EC
REP
Authorized Representative in the
European Community
Date of Manufacture Importer
MD
Medical Device
UDIUDI
Unique Device Identifier
REFREF
Catalogue number
CC
Country of Manufacture
MRMR
!
!
• applying the pulse oximeter on the
same arm as a blood pressure cuff,
arterial catheter or infusion line(s)
(IVs)
• excessive light, such as sunlight or
direct home lighting
• excessive motion
• moisture in the device
• improperly applied device
• finger is outside recommended size
range
• poor pulse quality
• venous pulsations
• cardiogreen and other intravascular
dyes
• anemia or low hemoglobin
concentrations
• carboxyhemoglobin
• methemoglobin
• dysfunctional hemoglobin
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.
Nonin Medical, Inc.
13700 1st Avenue North
Plymouth, Minnesota 55441-5443 USA
[phone] (USA/Canada)
[phone] (outside USA and Canada)
E-mail: [e-mail]
Nonin Medical B.V.
Doctor Paul Janssenweg 150
5026 RH Tilburg, Netherlands
+31 (0)13 - 45 87 130 (Europe)
E-mail: [e-mail]
nonin.com
70 75 80 85 90 95 100
−6−4−20246
SpO
2
−SaO
2
(%)
Bias=0
Limits of Agreement
Linear Regression
2
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SpO
2
−SaO
2
(%)
Finger
Thumb
Accuracy Summary – Finger and Thumb
Range Specified Oxygen
Saturation (Arms)
Thumb Oxygen
Saturation (Arms)
Low Perfusion
Oxygen Saturation (Arms)
70 – 100% ± 2 ± 1.56 ± 2
70 – 80% ± 2 ± 1.91 ± 2
80 – 90% ± 2 ± 1.21 ± 2
90 – 100% ± 2 ± 1.49 ± 2
Finger Oxygen
Saturation (Arms)
± 1.31
± 1.65
± 1.05
± 1.18
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.
11038-001-05 03/2022
© 2022 Nonin Medical, Inc.
Nonin Medical, Inc.
13700 1st Avenue North
Plymouth, MN 55441, USA
www.nonin.com
E-mail: [e-mail]
[phone]
[phone] (US and Canada)
Fax: [phone]
Nonin Medical B.V.
Doctor Paul Janssenweg 150
5026 RH Tilburg, Netherlands
Email: [e-mail] (Europe)
+31 (0)13 - 45 87 130 (Europe)
Nonin, NoninConnect Elite, and CorrectCheck are trademarks of Nonin Medical, Inc.
U.S. Patents 5,490,523; 5,792,052; other patents pending.
The Bluetooth® word mark and logo are registered trademarks owned by Bluetooth SIG, Inc.
Installing AAA Batteries
WARNING: Before changing
batteries, make sure the device is
off and is not applied to a digit.
1. Hold the 3240 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 3240.
4. If applicable, remove the
old batteries from the 3240.
Properly dispose of the
batteries.
5. Insert two new 1.5 volt AAA-
size batteries. Carefully match
the polarity markings (+ and -).
The 3240 will not work if the
batteries are inserted the
wrong way.
6. Carefully slide the battery door
back onto the device.
NONINCONNECT ELITE MODEL 3240
NONIN MEDICAL, INC.
PLYMOUTH, MN USA
IP32
NONINCONNECT ELITE MODEL 3240
NONIN MEDICAL, INC.
PLYMOUTH, MN USA
IP32
Turning On the NoninConnect
Elite Model 3240
1. Insert a digit into the Model 3240
until it touches the built-in stop.
NOTE: Make sure the finger is lying
flat (not on its side) and is centered
within the device. 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 3240 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 device 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.
Instructions for Use – English
NoninConnect Elite™ Model 3240
Bluetooth®Smart Pulse Oximeter
Indications for Use
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.
CAUTION: 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.
Contraindications
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.
Warnings
• Use the Model 3240 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 6 to 8 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.
Cautions
• This device has no audible alarms and is intended only for spot-checking.
•
T his 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
followi ng:
• 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 qualified technical professionals. 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.
• Portable and mobile RF communications equipment including CT, diathermy, RFID, and electronic article
security systems can affect medical electrical equipment.
• When device is connected via Bluetooth, other Wi-Fi devices within 6 meters (20 feet) could interrupt the
Bluetooth connection.
• 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
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
Using the NoninConnect Elite Model 3240
Installing AAA Batteries
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.
Turning On the NoninConnect Elite Model 3240
See the “Turning on the NoninConnect Elite Model 3240” instructions and figures at left.
Connection via Bluetooth Wireless Technology
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.
Turning Off the NoninConnect Elite Model 3240
The Model 3240 will automatically turn off approximately 10 seconds after the digit is removed, or after a 2-minute
period of poor signals.
Cleaning the NoninConnect Elite Model 3240
CAUTIONS:
!
• 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
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-warran
ty work shall be done at Nonin’s standard rates and charges in effect at the time
of delivery to Nonin.
www.nonin.com/warranty
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.
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 Arms values measured using the Model 3240 in a
clinical study.
NOTE: If your national regulatory authority recognizes accuracy in motion, please contact
[e-mail] for accuracy data.
Pulse Rate Declared Accuracy Range (Arms)*: 20 to 250 BPM ±3 digits
Low Perfusion Pulse Rate Declared Accuracy Range (Arms)*: 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
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. CAUTION: 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 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 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)
Bluetooth Security
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.”
Symbol Definition Symbol Definition
!
Caution! Not for continuous monitoring (no
alarm for SpO2)
Follow Instructions for Use. Battery orientation
Consult Instructions for Use.
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.
MRMR
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.
SN Serial Number
BDA Bluetooth Device Address
Storage/shipping temperature range
CE Marking indicating conformance to
EC Directive No. 93/42/EEC
concerning medical devices.
Handle with Care
Keep Dry
Radio Equipment Class Identifier RCM Australia
Non-ionizing electromagnetic radiation.
Equipment includes RF transmitters.
Interference may occur in the vicinity of
equipment marked with this symbol.
Medical prescription required
Manufacturer
Indicates separate collection for electrical
and electronic equipment (WEEE)
EC
REP
Authorized Representative in the
European Community
Date of Manufacture Importer
MD
Medical Device
UDIUDI
Unique Device Identifier
REFREF
Catalogue number
CC
Country of Manufacture
MRMR
!
!
• applying the pulse oximeter on the
same arm as a blood pressure cuff,
arterial catheter or infusion line(s)
(IVs)
• excessive light, such as sunlight or
direct home lighting
• excessive motion
• moisture in the device
• improperly applied device
• finger is outside recommended size
range
• poor pulse quality
• venous pulsations
• cardiogreen and other intravascular
dyes
• anemia or low hemoglobin
concentrations
• carboxyhemoglobin
• methemoglobin
• dysfunctional hemoglobin
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.
Nonin Medical, Inc.
13700 1st Avenue North
Plymouth, Minnesota 55441-5443 USA
[phone] (USA/Canada)
[phone] (outside USA and Canada)
E-mail: [e-mail]
Nonin Medical B.V.
Doctor Paul Janssenweg 150
5026 RH Tilburg, Netherlands
+31 (0)13 - 45 87 130 (Europe)
E-mail: [e-mail]
nonin.com
70 75 80 85 90 95 100
−6−4−20246
SpO
2
−SaO
2
(%)
Bias=0
Limits of Agreement
Linear Regression
2
2
2
2
2
2
2
2
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SpO
2
−SaO
2
(%)
Finger
Thumb
Accuracy Summary – Finger and Thumb
Range Specified Oxygen
Saturation (Arms)
Thumb Oxygen
Saturation (Arms)
Low Perfusion
Oxygen Saturation (Arms)
70 – 100% ± 2 ± 1.56 ± 2
70 – 80% ± 2 ± 1.91 ± 2
80 – 90% ± 2 ± 1.21 ± 2
90 – 100% ± 2 ± 1.49 ± 2
Finger Oxygen
Saturation (Arms)
± 1.31
± 1.65
± 1.05
± 1.18
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.
11038-001-05 03/2022
© 2022 Nonin Medical, Inc.
Nonin Medical, Inc.
13700 1st Avenue North
Plymouth, MN 55441, USA
www.nonin.com
E-mail: [e-mail]
[phone]
[phone] (US and Canada)
Fax: [phone]
Nonin Medical B.V.
Doctor Paul Janssenweg 150
5026 RH Tilburg, Netherlands
Email: [e-mail] (Europe)
+31 (0)13 - 45 87 130 (Europe)
Nonin, NoninConnect Elite, and CorrectCheck are trademarks of Nonin Medical, Inc.
U.S. Patents 5,490,523; 5,792,052; other patents pending.
The Bluetooth® word mark and logo are registered trademarks owned by Bluetooth SIG, Inc.
Installing AAA Batteries
WARNING: Before changing
batteries, make sure the device is
off and is not applied to a digit.
1. Hold the 3240 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 3240.
4. If applicable, remove the
old batteries from the 3240.
Properly dispose of the
batteries.
5. Insert two new 1.5 volt AAA-
size batteries. Carefully match
the polarity markings (+ and -).
The 3240 will not work if the
batteries are inserted the
wrong way.
6. Carefully slide the battery door
back onto the device.
NONINCONNECT ELITE MODEL 3240
NONIN MEDICAL, INC.
PLYMOUTH, MN USA
IP32
NONINCONNECT ELITE MODEL 3240
NONIN MEDICAL, INC.
PLYMOUTH, MN USA
IP32
Turning On the NoninConnect
Elite Model 3240
1. Insert a digit into the Model 3240
until it touches the built-in stop.
NOTE: Make sure the finger is lying
flat (not on its side) and is centered
within the device. 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 3240 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 device 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.
Instructions for Use – English
NoninConnect Elite™ Model 3240
Bluetooth®Smart Pulse Oximeter
Indications for Use
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.
CAUTION: 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.
Contraindications
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.
Warnings
• Use the Model 3240 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 6 to 8 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.
Cautions
• This device has no audible alarms and is intended only for spot-checking.
•
T his 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
followi ng:
• 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 qualified technical professionals. 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.
• Portable and mobile RF communications equipment including CT, diathermy, RFID, and electronic article
security systems can affect medical electrical equipment.
• When device is connected via Bluetooth, other Wi-Fi devices within 6 meters (20 feet) could interrupt the
Bluetooth connection.
• 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
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
Using the NoninConnect Elite Model 3240
Installing AAA Batteries
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.
Turning On the NoninConnect Elite Model 3240
See the “Turning on the NoninConnect Elite Model 3240” instructions and figures at left.
Connection via Bluetooth Wireless Technology
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.
Turning Off the NoninConnect Elite Model 3240
The Model 3240 will automatically turn off approximately 10 seconds after the digit is removed, or after a 2-minute
period of poor signals.
Cleaning the NoninConnect Elite Model 3240
CAUTIONS:
!
• 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
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-warran
ty work shall be done at Nonin’s standard rates and charges in effect at the time
of delivery to Nonin.
www.nonin.com/warranty
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.
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 Arms values measured using the Model 3240 in a
clinical study.
NOTE: If your national regulatory authority recognizes accuracy in motion, please contact
[e-mail] for accuracy data.
Pulse Rate Declared Accuracy Range (Arms)*: 20 to 250 BPM ±3 digits
Low Perfusion Pulse Rate Declared Accuracy Range (Arms)*: 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
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. CAUTION: 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 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 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)
Bluetooth Security
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.”
Symbol Definition Symbol Definition
!
Caution! Not for continuous monitoring (no
alarm for SpO2)
Follow Instructions for Use. Battery orientation
Consult Instructions for Use.
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.
MRMR
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.
SN Serial Number
BDA Bluetooth Device Address
Storage/shipping temperature range
CE Marking indicating conformance to
EC Directive No. 93/42/EEC
concerning medical devices.
Handle with Care
Keep Dry
Radio Equipment Class Identifier RCM Australia
Non-ionizing electromagnetic radiation.
Equipment includes RF transmitters.
Interference may occur in the vicinity of
equipment marked with this symbol.
Medical prescription required
Manufacturer
Indicates separate collection for electrical
and electronic equipment (WEEE)
EC
REP
Authorized Representative in the
European Community
Date of Manufacture Importer
MD
Medical Device
UDIUDI
Unique Device Identifier
REFREF
Catalogue number
CC
Country of Manufacture
MRMR
!
!
• applying the pulse oximeter on the
same arm as a blood pressure cuff,
arterial catheter or infusion line(s)
(IVs)
• excessive light, such as sunlight or
direct home lighting
• excessive motion
• moisture in the device
• improperly applied device
• finger is outside recommended size
range
• poor pulse quality
• venous pulsations
• cardiogreen and other intravascular
dyes
• anemia or low hemoglobin
concentrations
• carboxyhemoglobin
• methemoglobin
• dysfunctional hemoglobin
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.
Nonin Medical, Inc.
13700 1st Avenue North
Plymouth, Minnesota 55441-5443 USA
[phone] (USA/Canada)
[phone] (outside USA and Canada)
E-mail: [e-mail]
Nonin Medical B.V.
Doctor Paul Janssenweg 150
5026 RH Tilburg, Netherlands
+31 (0)13 - 45 87 130 (Europe)
E-mail: [e-mail]
nonin.com
70 75 80 85 90 95 100
−6−4−20246
SpO
2
−SaO
2
(%)
Bias=0
Limits of Agreement
Linear Regression
2
2
2
2
2
2
2
2
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2
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33
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SpO
2
−SaO
2
(%)
Finger
Thumb
Accuracy Summary – Finger and Thumb
Range Specified Oxygen
Saturation (Arms)
Thumb Oxygen
Saturation (Arms)
Low Perfusion
Oxygen Saturation (Arms)
70 – 100% ± 2 ± 1.56 ± 2
70 – 80% ± 2 ± 1.91 ± 2
80 – 90% ± 2 ± 1.21 ± 2
90 – 100% ± 2 ± 1.49 ± 2
Finger Oxygen
Saturation (Arms)
± 1.31
± 1.65
± 1.05
± 1.18
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.

11038-001-05 03/2022
© 2022 Nonin Medical, Inc.
Nonin Medical, Inc.
13700 1st Avenue North
Plymouth, MN 55441, USA
www.nonin.com
E-mail: [e-mail]
[phone]
[phone] (US and Canada)
Fax: [phone]
Nonin Medical B.V.
Doctor Paul Janssenweg 150
5026 RH Tilburg, Netherlands
Email: [e-mail] (Europe)
+31 (0)13 - 45 87 130 (Europe)
Nonin, NoninConnect Elite, and CorrectCheck are trademarks of Nonin Medical, Inc.
U.S. Patents 5,490,523; 5,792,052; other patents pending.
The Bluetooth® word mark and logo are registered trademarks owned by Bluetooth SIG, Inc.
Installing AAA Batteries
WARNING: Before changing
batteries, make sure the device is
off and is not applied to a digit.
1. Hold the 3240 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 3240.
4. If applicable, remove the
old batteries from the 3240.
Properly dispose of the
batteries.
5. Insert two new 1.5 volt AAA-
size batteries. Carefully match
the polarity markings (+ and -).
The 3240 will not work if the
batteries are inserted the
wrong way.
6. Carefully slide the battery door
back onto the device.
NONINCONNECT ELITE MODEL 3240
NONIN MEDICAL, INC.
PLYMOUTH, MN USA
IP32
NONINCONNECT ELITE MODEL 3240
NONIN MEDICAL, INC.
PLYMOUTH, MN USA
IP32
Turning On the NoninConnect
Elite Model 3240
1. Insert a digit into the Model 3240
until it touches the built-in stop.
NOTE: Make sure the finger is lying
flat (not on its side) and is centered
within the device. 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 3240 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 device 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.
Instructions for Use – English
NoninConnect Elite™ Model 3240
Bluetooth®Smart Pulse Oximeter
Indications for Use
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.
CAUTION: 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.
Contraindications
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.
Warnings
• Use the Model 3240 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 6 to 8 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.
Cautions
• This device has no audible alarms and is intended only for spot-checking.
•
T his 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
followi ng:
• 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 qualified technical professionals. 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.
• Portable and mobile RF communications equipment including CT, diathermy, RFID, and electronic article
security systems can affect medical electrical equipment.
• When device is connected via Bluetooth, other Wi-Fi devices within 6 meters (20 feet) could interrupt the
Bluetooth connection.
• 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
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
Using the NoninConnect Elite Model 3240
Installing AAA Batteries
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.
Turning On the NoninConnect Elite Model 3240
See the “Turning on the NoninConnect Elite Model 3240” instructions and figures at left.
Connection via Bluetooth Wireless Technology
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.
Turning Off the NoninConnect Elite Model 3240
The Model 3240 will automatically turn off approximately 10 seconds after the digit is removed, or after a 2-minute
period of poor signals.
Cleaning the NoninConnect Elite Model 3240
CAUTIONS:
!
• 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
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-warran
ty work shall be done at Nonin’s standard rates and charges in effect at the time
of delivery to Nonin.
www.nonin.com/warranty
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.
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 Arms values measured using the Model 3240 in a
clinical study.
NOTE: If your national regulatory authority recognizes accuracy in motion, please contact
[e-mail] for accuracy data.
Pulse Rate Declared Accuracy Range (Arms)*: 20 to 250 BPM ±3 digits
Low Perfusion Pulse Rate Declared Accuracy Range (Arms)*: 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
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. CAUTION: 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 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 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)
Bluetooth Security
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.”
Symbol Definition Symbol Definition
!
Caution! Not for continuous monitoring (no
alarm for SpO2)
Follow Instructions for Use. Battery orientation
Consult Instructions for Use.
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.
MRMR
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.
SN Serial Number
BDA Bluetooth Device Address
Storage/shipping temperature range
CE Marking indicating conformance to
EC Directive No. 93/42/EEC
concerning medical devices.
Handle with Care
Keep Dry
Radio Equipment Class Identifier RCM Australia
Non-ionizing electromagnetic radiation.
Equipment includes RF transmitters.
Interference may occur in the vicinity of
equipment marked with this symbol.
Medical prescription required
Manufacturer
Indicates separate collection for electrical
and electronic equipment (WEEE)
EC
REP
Authorized Representative in the
European Community
Date of Manufacture Importer
MD
Medical Device
UDIUDI
Unique Device Identifier
REFREF
Catalogue number
CC
Country of Manufacture
MRMR
!
!
• applying the pulse oximeter on the
same arm as a blood pressure cuff,
arterial catheter or infusion line(s)
(IVs)
• excessive light, such as sunlight or
direct home lighting
• excessive motion
• moisture in the device
• improperly applied device
• finger is outside recommended size
range
• poor pulse quality
• venous pulsations
• cardiogreen and other intravascular
dyes
• anemia or low hemoglobin
concentrations
• carboxyhemoglobin
• methemoglobin
• dysfunctional hemoglobin
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.
Nonin Medical, Inc.
13700 1st Avenue North
Plymouth, Minnesota 55441-5443 USA
[phone] (USA/Canada)
[phone] (outside USA and Canada)
E-mail: [e-mail]
Nonin Medical B.V.
Doctor Paul Janssenweg 150
5026 RH Tilburg, Netherlands
+31 (0)13 - 45 87 130 (Europe)
E-mail: [e-mail]
nonin.com
70 75 80 85 90 95 100
−6−4−20246
SpO
2
−SaO
2
(%)
Bias=0
Limits of Agreement
Linear Regression
2
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SpO
2
−SaO
2
(%)
Finger
Thumb
Accuracy Summary – Finger and Thumb
Range Specified Oxygen
Saturation (Arms)
Thumb Oxygen
Saturation (Arms)
Low Perfusion
Oxygen Saturation (Arms)
70 – 100% ± 2 ± 1.56 ± 2
70 – 80% ± 2 ± 1.91 ± 2
80 – 90% ± 2 ± 1.21 ± 2
90 – 100% ± 2 ± 1.49 ± 2
Finger Oxygen
Saturation (Arms)
± 1.31
± 1.65
± 1.05
± 1.18
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.

11038-001-05 03/2022
© 2022 Nonin Medical, Inc.
Nonin Medical, Inc.
13700 1st Avenue North
Plymouth, MN 55441, USA
www.nonin.com
E-mail: [e-mail]
[phone]
[phone] (US and Canada)
Fax: [phone]
Nonin Medical B.V.
Doctor Paul Janssenweg 150
5026 RH Tilburg, Netherlands
Email: info[email protected] (Europe)
+31 (0)13 - 45 87 130 (Europe)
Nonin, NoninConnect Elite, and CorrectCheck are trademarks of Nonin Medical, Inc.
U.S. Patents 5,490,523; 5,792,052; other patents pending.
The Bluetooth® word mark and logo are registered trademarks owned by Bluetooth SIG, Inc.
Installing AAA Batteries
WARNING: Before changing
batteries, make sure the device is
off and is not applied to a digit.
1. Hold the 3240 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 3240.
4. If applicable, remove the
old batteries from the 3240.
Properly dispose of the
batteries.
5. Insert two new 1.5 volt AAA-
size batteries. Carefully match
the polarity markings (+ and -).
The 3240 will not work if the
batteries are inserted the
wrong way.
6. Carefully slide the battery door
back onto the device.
NONINCONNECT ELITE MODEL 3240
NONIN MEDICAL, INC.
PLYMOUTH, MN USA
IP32
NONINCONNECT ELITE MODEL 3240
NONIN MEDICAL, INC.
PLYMOUTH, MN USA
IP32
Turning On the NoninConnect
Elite Model 3240
1. Insert a digit into the Model 3240
until it touches the built-in stop.
NOTE: Make sure the finger is lying
flat (not on its side) and is centered
within the device. 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 3240 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 device 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.
Instructions for Use – English
NoninConnect Elite™ Model 3240
Bluetooth®Smart Pulse Oximeter
Indications for Use
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.
CAUTION: 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.
Contraindications
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.
Warnings
• Use the Model 3240 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 6 to 8 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.
Cautions
• This device has no audible alarms and is intended only for spot-checking.
•
T his 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
followi ng:
• 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 qualified technical professionals. 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.
• Portable and mobile RF communications equipment including CT, diathermy, RFID, and electronic article
security systems can affect medical electrical equipment.
• When device is connected via Bluetooth, other Wi-Fi devices within 6 meters (20 feet) could interrupt the
Bluetooth connection.
• 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
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
Using the NoninConnect Elite Model 3240
Installing AAA Batteries
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.
Turning On the NoninConnect Elite Model 3240
See the “Turning on the NoninConnect Elite Model 3240” instructions and figures at left.
Connection via Bluetooth Wireless Technology
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.
Turning Off the NoninConnect Elite Model 3240
The Model 3240 will automatically turn off approximately 10 seconds after the digit is removed, or after a 2-minute
period of poor signals.
Cleaning the NoninConnect Elite Model 3240
CAUTIONS:
!
• 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
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-warran
ty work shall be done at Nonin’s standard rates and charges in effect at the time
of delivery to Nonin.
www.nonin.com/warranty
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.
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 Arms values measured using the Model 3240 in a
clinical study.
NOTE: If your national regulatory authority recognizes accuracy in motion, please contact
[email protected] for accuracy data.
Pulse Rate Declared Accuracy Range (Arms)*: 20 to 250 BPM ±3 digits
Low Perfusion Pulse Rate Declared Accuracy Range (Arms)*: 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
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. CAUTION: 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 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 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)
Bluetooth Security
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.”
Symbol Definition Symbol Definition
!
Caution! Not for continuous monitoring (no
alarm for SpO2)
Follow Instructions for Use. Battery orientation
Consult Instructions for Use.
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.
MRMR
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.
SN Serial Number
BDA Bluetooth Device Address
Storage/shipping temperature range
CE Marking indicating conformance to
EC Directive No. 93/42/EEC
concerning medical devices.
Handle with Care
Keep Dry
Radio Equipment Class Identifier RCM Australia
Non-ionizing electromagnetic radiation.
Equipment includes RF transmitters.
Interference may occur in the vicinity of
equipment marked with this symbol.
Medical prescription required
Manufacturer
Indicates separate collection for electrical
and electronic equipment (WEEE)
EC
REP
Authorized Representative in the
European Community
Date of Manufacture Importer
MD
Medical Device
UDIUDI
Unique Device Identifier
REFREF
Catalogue number
CC
Country of Manufacture
MRMR
!
!
• applying the pulse oximeter on the
same arm as a blood pressure cuff,
arterial catheter or infusion line(s)
(IVs)
• excessive light, such as sunlight or
direct home lighting
• excessive motion
• moisture in the device
• improperly applied device
• finger is outside recommended size
range
• poor pulse quality
• venous pulsations
• cardiogreen and other intravascular
dyes
• anemia or low hemoglobin
concentrations
• carboxyhemoglobin
• methemoglobin
• dysfunctional hemoglobin
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.
Nonin Medical, Inc.
13700 1st Avenue North
Plymouth, Minnesota 55441-5443 USA
[phone] (USA/Canada)
[phone] (outside USA and Canada)
E-mail: [email protected]
Nonin Medical B.V.
Doctor Paul Janssenweg 150
5026 RH Tilburg, Netherlands
+31 (0)13 - 45 87 130 (Europe)
E-mail: [email protected]
nonin.com
70 75 80 85 90 95 100
−6−4−20246
SpO
2
−SaO
2
(%)
Bias=0
Limits of Agreement
Linear Regression
2
2
2
2
2
2
2
2
2
2
2
2
2
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SpO
2
−SaO
2
(%)
Finger
Thumb
Accuracy Summary – Finger and Thumb
Range Specified Oxygen
Saturation (Arms)
Thumb Oxygen
Saturation (Arms)
Low Perfusion
Oxygen Saturation (Arms)
70 – 100% ± 2 ± 1.56 ± 2
70 – 80% ± 2 ± 1.91 ± 2
80 – 90% ± 2 ± 1.21 ± 2
90 – 100% ± 2 ± 1.49 ± 2
Finger Oxygen
Saturation (Arms)
± 1.31
± 1.65
± 1.05
± 1.18
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.

11038-001-05 03/2022
© 2022 Nonin Medical, Inc.
Nonin Medical, Inc.
13700 1st Avenue North
Plymouth, MN 55441, USA
www.nonin.com
E-mail: [e-mail]
[phone]
[phone] (US and Canada)
Fax: [phone]
Nonin Medical B.V.
Doctor Paul Janssenweg 150
5026 RH Tilburg, Netherlands
Email: info[email protected] (Europe)
+31 (0)13 - 45 87 130 (Europe)
Nonin, NoninConnect Elite, and CorrectCheck are trademarks of Nonin Medical, Inc.
U.S. Patents 5,490,523; 5,792,052; other patents pending.
The Bluetooth® word mark and logo are registered trademarks owned by Bluetooth SIG, Inc.
Installing AAA Batteries
WARNING: Before changing
batteries, make sure the device is
off and is not applied to a digit.
1. Hold the 3240 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 3240.
4. If applicable, remove the
old batteries from the 3240.
Properly dispose of the
batteries.
5. Insert two new 1.5 volt AAA-
size batteries. Carefully match
the polarity markings (+ and -).
The 3240 will not work if the
batteries are inserted the
wrong way.
6. Carefully slide the battery door
back onto the device.
NONINCONNECT ELITE MODEL 3240
NONIN MEDICAL, INC.
PLYMOUTH, MN USA
IP32
NONINCONNECT ELITE MODEL 3240
NONIN MEDICAL, INC.
PLYMOUTH, MN USA
IP32
Turning On the NoninConnect
Elite Model 3240
1. Insert a digit into the Model 3240
until it touches the built-in stop.
NOTE: Make sure the finger is lying
flat (not on its side) and is centered
within the device. 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 3240 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 device 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.
Instructions for Use – English
NoninConnect Elite™ Model 3240
Bluetooth®Smart Pulse Oximeter
Indications for Use
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.
CAUTION: 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.
Contraindications
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.
Warnings
• Use the Model 3240 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 6 to 8 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.
Cautions
• This device has no audible alarms and is intended only for spot-checking.
•
T his 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
followi ng:
• 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 qualified technical professionals. 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.
• Portable and mobile RF communications equipment including CT, diathermy, RFID, and electronic article
security systems can affect medical electrical equipment.
• When device is connected via Bluetooth, other Wi-Fi devices within 6 meters (20 feet) could interrupt the
Bluetooth connection.
• 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
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
Using the NoninConnect Elite Model 3240
Installing AAA Batteries
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.
Turning On the NoninConnect Elite Model 3240
See the “Turning on the NoninConnect Elite Model 3240” instructions and figures at left.
Connection via Bluetooth Wireless Technology
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.
Turning Off the NoninConnect Elite Model 3240
The Model 3240 will automatically turn off approximately 10 seconds after the digit is removed, or after a 2-minute
period of poor signals.
Cleaning the NoninConnect Elite Model 3240
CAUTIONS:
!
• 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
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-warran
ty work shall be done at Nonin’s standard rates and charges in effect at the time
of delivery to Nonin.
www.nonin.com/warranty
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.
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 Arms values measured using the Model 3240 in a
clinical study.
NOTE: If your national regulatory authority recognizes accuracy in motion, please contact
[e-mail] for accuracy data.
Pulse Rate Declared Accuracy Range (Arms)*: 20 to 250 BPM ±3 digits
Low Perfusion Pulse Rate Declared Accuracy Range (Arms)*: 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
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. CAUTION: 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 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 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)
Bluetooth Security
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.”
Symbol Definition Symbol Definition
!
Caution! Not for continuous monitoring (no
alarm for SpO2)
Follow Instructions for Use. Battery orientation
Consult Instructions for Use.
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.
MRMR
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.
SN Serial Number
BDA Bluetooth Device Address
Storage/shipping temperature range
CE Marking indicating conformance to
EC Directive No. 93/42/EEC
concerning medical devices.
Handle with Care
Keep Dry
Radio Equipment Class Identifier RCM Australia
Non-ionizing electromagnetic radiation.
Equipment includes RF transmitters.
Interference may occur in the vicinity of
equipment marked with this symbol.
Medical prescription required
Manufacturer
Indicates separate collection for electrical
and electronic equipment (WEEE)
EC
REP
Authorized Representative in the
European Community
Date of Manufacture Importer
MD
Medical Device
UDIUDI
Unique Device Identifier
REFREF
Catalogue number
CC
Country of Manufacture
MRMR
!
!
• applying the pulse oximeter on the
same arm as a blood pressure cuff,
arterial catheter or infusion line(s)
(IVs)
• excessive light, such as sunlight or
direct home lighting
• excessive motion
• moisture in the device
• improperly applied device
• finger is outside recommended size
range
• poor pulse quality
• venous pulsations
• cardiogreen and other intravascular
dyes
• anemia or low hemoglobin
concentrations
• carboxyhemoglobin
• methemoglobin
• dysfunctional hemoglobin
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.
Nonin Medical, Inc.
13700 1st Avenue North
Plymouth, Minnesota 55441-5443 USA
[phone] (USA/Canada)
[phone] (outside USA and Canada)
E-mail: [email protected]
Nonin Medical B.V.
Doctor Paul Janssenweg 150
5026 RH Tilburg, Netherlands
+31 (0)13 - 45 87 130 (Europe)
E-mail: [email protected]
nonin.com
70 75 80 85 90 95 100
−6−4−20246
SpO
2
−SaO
2
(%)
Bias=0
Limits of Agreement
Linear Regression
2
2
2
2
2
2
2
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SpO
2
−SaO
2
(%)
Finger
Thumb
Accuracy Summary – Finger and Thumb
Range Specified Oxygen
Saturation (Arms)
Thumb Oxygen
Saturation (Arms)
Low Perfusion
Oxygen Saturation (Arms)
70 – 100% ± 2 ± 1.56 ± 2
70 – 80% ± 2 ± 1.91 ± 2
80 – 90% ± 2 ± 1.21 ± 2
90 – 100% ± 2 ± 1.49 ± 2
Finger Oxygen
Saturation (Arms)
± 1.31
± 1.65
± 1.05
± 1.18
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.