ENG – Translations of the IFU can be found using this QR code.
FRE – Les traductions de cette notice d’utilisation peuvent être retrouvées à l’aide de ce code QR.
GER – Übersetzungen dieses Handbuchs können über diesen QR-Code abgerufen werden.
ITL – Utilizzando questo codice QR, è possibile trovare le traduzioni delle Istruzioni per l’uso.
SPA – Las traducciones de este manual se pueden encontrar utilizando este código QR.
POR – Pode aceder às traduções das instruções de utilização através deste código QR.
DUT – Vertalingen van de handleiding zijn te vinden met behulp van deze QR-code.
GRK – ΜετηχρήσηαυτούτουκωδικούQRμπορείτεναβρείτεμεταφράσεις
τωνοδηγιώνχρήσης(IFU).
DAN – ScandenneQR-kodeforatndeoversættelserafdennebrugsvejledning.
SWE – Översättningar av den här guiden kan hittas med denna QR-kod.
FIN – Käyttöohjeen käännökset löytyvät tällä QR-koodilla.
POL – TłumaczeniategoprzewodnikamożnaznaleźćzapomocątegokoduQR.
NOR – OversettelseravdennebruksanvisningenkannnesvedåbrukedenneQR-koden.
Instructions for Use / Operator’s Manual
P/N 114989-001-01 03/2023 13700 1st Avenue North, Plymouth, MN 55441-5443 USA nonin.com
Instructions for Use
Model 3150
REPEC
Warranty
The device warranty
is 3 years.
nonin.com/warranty
Symbol
Glossary
nonin.com/symbols
Compliance
This product complies
with ISO 10993.
Not made from
natural rubber latex.
MPS, Medical Product Service GmbH
Borngasse 20
D-35619 Braunfels, Germany
MedEnvoy Switzerland
Gotthardstrasse 28, 6302 Zug
Switzerland
REP
CH
Warnings (continued)
• This device should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the device should be
observed carefully to verify normal operation.
• The use of accessories, sensors, and cables other than those listed in the Parts and Accessories List may result in increased electromagnetic
emission and/or decreased immunity of this device.
• Do not use the device when alarms are required.
• Do not use a damaged sensor. If the sensor is damaged in any way, discontinue use immediately and replace the sensor.
• ThisequipmentcomplieswithInternationalIEC60601-1-2forelectromagneticcompatibility(EMC)formedicalelectricalequipmentand/or
systems. This standard is designed to provide reasonable protection against harmful interference in a typical medical installation. However, be-
cause of the proliferation of radio-frequency transmitting equipment and other sources of electrical noise in healthcare 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
theEMCinformationspeciedinthismanual.
• Only use Nonin-branded sensors with a length of 1 meter or less. Accuracy may degrade if sensor cable is over 1 meter in length. Using the
sensor cable adapter does not affect accuracy.
• PortableRFcommunicationsequipmentsuchascellphonesorradios(includingperipheralssuchasantennacablesandexternalantennas)
shouldbeusednocloserthan30cm(12inches)toanypartoftheMEsystem,includingcablesspeciedbythemanufacturer.Otherwise,
degradation of the performance of this equipment could result.
Cautions
• If this device fails to respond as described, refer to “Troubleshooting” or discontinue use until the situation has been corrected. Contact Nonin
Technical Service.
• This device has motion tolerant software that minimizes the likelihood of motion artifact being misinterpreted as good pulse quality. In some
circumstances, however, the device may still interpret motion as good pulse quality.
• Do not place liquids on top of this device.
• When setting the clock in Programmed Activation Mode using nVISION software, verify all set times and dates are valid.
• Do not place the WristOx2, Model 3150, in liquid or clean it with agents containing ammonium chloride or isopropyl alcohol. Refer to the “Care
and Maintenance” section of this operator’s manual.
• Use a detergent that is safe for skin and washable surfaces. Most detergents can be high sudsing, so use sparingly. Wipe with a damp, deter-
gent free cloth to remove residue.
• After cleaning the multiple use wristband, it should only be applied to the same patient; do not apply it to a different patient.
• Follow local, state, and national governing ordinances and recycling instructions regarding disposal or recycling of the device and device compo-
nents, including batteries.
• IncompliancewiththeEuropeanDirectiveonWasteElectricalandElectronicEquipment(WEEE)2002/96/EC,donotdisposeofthisproductas
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.
• This device is designed to determine the percentage of arterial oxygen saturation of functional hemoglobin. Factors that may degrade pulse
oximeter performance or affect the accuracy of the measurement include the following:
• When using the monitor in the home, avoid exposing the monitor to lint and dust.
• When using the monitor around small children and pets, avoid leaving the monitor unattended. Cables pose a risk of injury, including strangulation.
• Do not perform any testing or maintenance on this device while it is being used to monitor a patient.
• This device is a precision electronic instrument and must be repaired by Nonin Technical Service. Field repair of this device is not possible.
Except to replace batteries, do not attempt to open the case or repair the electronics. Opening the case may damage the device and void the
warranty.
• Verifyallvisibleindicatorsappearduringthestart-up(initialization)sequence.Ifanyindicatordoesnotappear,donotusethedevice.Contact
Nonin Technical Service for assistance.
• 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.
• To avoid the risk of confusing or misinterpreting patient data when transmitting data via Bluetooth, verify the device is paired with the correct
display unit.
• Thepulseoximetermaynotworkwhencirculationisreduced.Warmorrubthengerorrepositionthesensor.
• A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor or sensor.
• Do not fasten the device too tightly around the patient’s wrist. Inaccurate readings and patient discomfort could result.
• If the WristOx2, Model 3150 BLE is being used with wireless communication, use the device within its designated range of approximately 60
meters(sphericalradius).Movingoutsidethisrangemaycauselossofthewirelessconnection.
• Failureofanetworkdatacoupling(serialcable/connectors/wirelessconnections)willresultinlossofdatatransfer.
• If the time and date settings are lost while in Programmed Activation Mode, the device will revert to Spot Check Activation Mode.
• AllpartsandaccessoriesconnectedtotheserialportofthisdevicemustbecertiedaccordingtoatleastIECStandardEN60950,
IEC 62368-1, or UL 1950 for data-processing equipment.
Adverse Event Statement
Users and/or patients should report adverse events involve 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.
©2023 Nonin Medical, Inc. All trademarks are the property of Nonin Medical, Inc. unless otherwise noted.
• Excessive ambient light • Improperly applied sensor • Carboxyhemoglobin
• Excessive motion • Incorrect sensor type • Methemoglobin
• Electrosurgical interference • Poor pulse quality • Dysfunctional hemoglobin
• Bloodowrestrictors(arterialcatheters,
bloodpressurecuffs,infusionlines,etc.)
• Venous pulsations • Articialnailsorngernailpolish
• Anemia or low hemoglobin concentrations • Residue(e.g.,driedblood,dirt,grease,oil)
in the light path
• Moisture in the sensor • Cardiogreen and other intravascular dyes
P/N 114989-001-01 03/2023 13700 1st Avenue North, Plymouth, MN 55441-5443 USA nonin.com
Instructions for Use
Model 3150
Thank you for trusting Nonin with your patients’ healthcare needs. We sincerely
appreciate your business. Please read your Operator’s Manual carefully and direct any
further questions to a Nonin Technical Service representative. If you would like to order
products or check the status of a current order, please contact Customer Service.
Indications for Use/Intended Use/Intended Purpose
The Nonin WristOx2®, Model 3150 Pulse Oximeter is a small, wrist-worn device indicated for use in measuring, displaying, and storing functional
oxygensaturationofarterialhemoglobin(%SpO2)andpulserate.Itisintendedforspot-checkingand/ordatacollectionandrecordingofadultand
pediatric patients, during both no motion and motion conditions, and for patients who are well or poorly perfused. The intended use environments are
hospitals, medical facilities,ambulatory, subacute, sleep study environments, and mobile units.
Warnings
• Donotuseinanexplosiveatmosphereorinthepresenceofammableanestheticsorgases.
• ThisdeviceisnotdebrillationproofperIEC60601-1.
• This device is intended only as an adjunct device in patient assessment. It must be used in conjunction with other methods of assessing clinical
signs and symptoms.
• Inspect the sensor application site at least every 4 hours to ensure correct sensor alignment and skin integrity. Patient sensitivity to sensors
and/or double-backed adhesive strips 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.
• To avoid patient injury, use only Nonin-branded PureLight® pulse oximeter sensors. These sensors are manufactured to meet the accuracy
specicationsforNoninpulseoximeters.Usingothermanufacturers’sensorscanresultinimproperpulseoximeterperformance.
• Topreventimproperperformanceand/orpatientinjury,verifycompatibilityofthemonitor,sensor(s),andaccessoriesbeforeuse.
• Nomodicationstothisdeviceareallowedasitmayaffectdeviceperformance.
• The USB cable must be unplugged from the device before replacing batteries.
• Before changing the batteries, make sure the device is off and the sensor is not applied to a digit.
Contact Customer Service or Technical Service
Toll Free: 800.356.8874 (U.S.andCanadaonly)
Phone: +1 763.553.9968
Email: [email protected]
Nonin Medical Inc.
13700 1st Avenue North
Plymouth, MN 55441-5443, USA
Nonin B.V.
Doctor Paul Janssenweg 150
5026 RH Tilburg, Netherlands
Have other questions or want to learn more?
Visit nonin.com to read more about our history, product offerings, and more.
Nonin is committed to sustainable practices. This paper is made with
FSC-certiedmaterials,printedwithsoyink,andis100%recyclable.
For summary of safety and clinical data see above QR code.
3150 Specications
*AdditionalspecicationsareavailableintheIFU/Operator’sManualthatcanbelocatedusingtheQRCode.
• Oxygensaturationmeasuredfrom0%-100%SpO2. With an accuracy typically ± 2 with a maximum of ± 3.
• Pulse rate measured from 18bpm-321bpm. With an accuracy data is typically ± 3 with a maximum of ± 5.
Measurement Wavelengths and Output Power:
• Red: 660 nanometers @ 0.8 mW maximum average
• Infrared: 910 nanometers @ 1.2 mW maximum average
https://www.nonin.com/support/wristworn
To set up and use the Nonin Model 3150 pulse oximeter, please
follow the simple instructions below.
Instructions for Use
Model 3150
P/N 114989-001-01 03/2023 13700 1st Avenue North, Plymouth, MN 55441-5443 USA nonin.com
Installing Batteries
1. Open the battery compartment by sliding the battery door off the back of the device.
2. Insert 2 new AAA batteries. Battery orientation is shown inside the battery
compartment.
3. Replace battery door by sliding it back into place.
4. Inserting batteries does not turn the device on. In Spot Check Activation Mode, the device
turnsonwhenangerisinsertedinthesensor.
P/N 114989-001-01 03/2023 13700 1st Avenue North, Plymouth, MN 55441-5443 USA nonin.com
Instructions for Use
Model 3150
Displays, Controls, and Indicators
Please refer to the Operator’s Manual on nonin.com/support/wristworn
for troubleshooting guidance and more detailed operating instructions.
P/N 114989-001-01 03/2023 13700 1st Avenue North, Plymouth, MN 55441-5443 USA nonin.com
Instructions for Use
Model 3150
Bluetooth Connection (BLE Model only)
Before a Bluetooth collector device can connect and obtain data from the 3150 BLE the devices must
bepaired.The3150BLEwillbeinpairingmodethersttimeitisactivatedfollowingthedetectionof
batteryinsertion.WheninpairingmodetheBluetoothicononthedisplaywillashoncepersecond.
After a connection and successful pairing, the Bluetooth icon will remain solid.
Nonin’s WristOx2Model3150BLE,usesaBluetoothLowEnergyradiowithamaximumrange(spherical
radius)ofabout60meters(196feet).Obstaclesandotherconditionsmayaffectrangeandbatterylife.
Operating Modes
The WristOx2 Model 3150, has two types of mode settings: Activation and Display, which are described
below. Activation modes determine how the 3150 turns off and on.
Spot Check Activation Mode is the factory default. Additional modes are available for the 3150, refer to
the Operator’s Manual for more information.
Memory Features
The WristOx2 Model 3150 measures, collects, and stores up to 1,080 hours of SpO2 and pulse rate data
with a 4-second data collection rate. Data collected at a 1 or 2-second rate reduces memory capacity to
270 or 540 hours, respectively.
When the memory is full, the device overwrites the oldest existing data with the new data. Each time
the device is turned on, data are automatically stored in memory. Data collection of less than 1 minute
is not retained in memory.
Nonin’s nVISION® software allows users to transfer recorded patient data from the device to a PC and
then analyze, report, and archive the data. The software is required to access the device’s additional
modes of operation and advanced features. See Operator’s Manual for more information on nVISION®.
Care and Maintenance
Clean the Model 3150 separately from the sensors. Please refer to the sensor’s Operator’s Manual for
information on how to clean the sensors and multiple use wristband.
To clean the Model 3150:
Wipethedevicewithasoftclothdampenedwitha10%bleach/90%watersolution(householdbleach
[containinglessthan10%sodiumhypochlorite]).Donotuseundilutedbleachoranycleaningsolution
other than those recommended here, as permanent damage could result. Dry with a soft cloth, or allow
to air dry. Clean once per week or more frequently if handled by multiple users.
Error Codes
This device includes error codes that indicate problems with the unit. See “Troubleshooting”
section with Operator’s Manual for codes and discriptions. If any indicator does not display, do not use
the device. Contact Nonin Technical Service for assistance.
Clinical Benets
Nonin pulse oximeters allow for the management of patients’ medical conditions by providing fast,
accurate, real-time, noninvasive oxygen measurement in order to meet patients’ medical needs.
Attaching the Wristband
The WristOx2 Model 3150, is designed to be applied to the patient’s wrist using a wristband.
There are two wristbands available for the use with the WristOx2 Model 3150 - a multiple use
wristband and a single use disposable wristband.
Long
Segment
Short
Segment
Thread Short
Segment Secure Long
Segment
Front View Back View
For more information on the displays, indicators, and controls, please refer to the Operator’s
Manual.
Sensor Port
Attaching the Sensor
1. Insert the sensor connector into the sensor port at the top of the device.
The Nonin logo on the sensor connector should face the front of the device.
2. Push the connector until it clicks into place.
3. The device is ready to use.
The sensor can be connected to the device before or after applying the device to the patient.
Refer to Operator’s Manual for applicable sensors and sizing.
%SpO2
Display
This 3-digit display, located in the upper left corner of the LCD, shows percent blood oxygen satu-
ration(%SpO2).Therangeisfrom0to100%
Pulse Rate
Display
This3-digitdisplay,locatedbelowthe%SpO2 display, shows the pulse rate in beats per minute
(BPM).Therangeisfrom18to321BPM.
Activation Switch The activation switch is located next to the sensor port at the top of the WristOx2 Model 3150.
Pressing the switch will turn on the device.
Sensor
Fault Indicator
Thisindicatordisplaysifthedevicedeterminesasensorfaultexists(e.g.,sensordisconnect,misalign-
ment,orincompatibilitywiththedevice).Italsodisplayswhenthengerisremovedfromthesensor.
Pulse Strength Indicator
- Full/Partial Display mode
- Memory Volume Display mode
A pulse strength indicator displays when the device is recording data. The bars on the display
depends on the pulse strength as determined by the oximeter.
This heart-shaped indicator is followed by up to nine curved bars and displays next to the pulse
rate.
This indicator consists of up to nine curved bars and displays next to the minutes of stored data.
Poor Pulse Signal
Indicator
This indicator displays when the pulse signal is inadequate or the device does not sense a pulse.
It may also display if there is excessive motion at the sensor site.
Battery Indicator Thisindicatorshowsremainingbatterylifeaseitherfull,half,low,andcritical(asshownatleft).
Replace the batteries when device reaches low state.
Bluetooth
Indicator
(BLEModelonly)
The Bluetooth indicator is used to show the current condition of the Bluetooth radio.
SmartPoint Indicator This indicator displays during the startup sequence.
Activation Switch
Patient Application
1. Verify the wristband has been attached properly to the device.
2. Place the device on the patient’s wrist.
3. If using the multiple use wristband, thread the rounded end of the wristband through the
plasticring.Pullthestrapthroughtheplasticringuntilthedevicetscomfortablyonthe
wrist.
4. Fold the wristband back over the plastic ring and attach the fastener to the wristband.
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