Nonin 3150 Instructions For Use

Model 3150
Instructions for Use
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.
Contact Customer Service or Technical Service
(U.S. and Canada only)
Toll Free: 800.356.8874
Phone: +1 763.553.9968
Email: customerservice@nonin.com
Nonin Medical Inc. Nonin B.V.
13700 1st Avenue North Doctor Paul Janssenweg 150
Plymouth, MN 55441-5443, USA 5026 RH Tilburg, Netherlands
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3150 Specifications
*Additional specifications are available in the IFU/Operator's Manual that can be located using the QR Code.
Oxygen saturation measured from 0%-100% SpO
• . With an accuracy typically ± 2 with a maximum of ± 3.
2
• 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
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
oxygen saturation of arterial hemoglobin(%SpO2) and pulse rate. It is intended for spot-checking and/or data collection and recording of adult and
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
• Do not use in an explosive atmosphere or in the presence of flammable anesthetics or gases.
• This device is not defibrillation proof per IEC 60601-1.
• 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
specifications for Nonin pulse oximeters. Using other manufacturers' sensors can result in improper pulse oximeter performance.
• To prevent improper performance and/or patient injury, verify compatibility of the monitor, sensor(s), and accessories before use.
• No modifications to this device are allowed as it may affect device performance.
• 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.
P/N 114989-001-01 03/2023 13700 1st Avenue North, Plymouth, MN 55441-5443 USA
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.
• This equipment complies with International IEC 60601-1-2 for electromagnetic compatibility (EMC) for medical electrical equipment and/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
the EMC information specified in this manual.
• 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.
• Portable RF communications equipment such as cell phones or radios (including peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any part of the ME system, including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
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.
• 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.
• 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:
• Excessive ambient light • Improperly applied sensor
• Excessive motion • Incorrect sensor type
• Electrosurgical interference • Poor pulse quality
• Blood flow restrictors (arterial catheters, • Venous pulsations
blood pressure cuffs, infusion lines, etc.)
• Anemia or low hemoglobin concentrations
• Moisture in the sensor • Cardiogreen and other intravascular dyes
• 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.
• Verify all visible indicators appear during the start-up (initialization) sequence. If any indicator does not appear, do not use the device. 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.
• The pulse oximeter may not work when circulation is reduced. Warm or rub the finger or reposition the sensor.
• 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 (spherical radius). Moving outside this range may cause loss of the wireless connection.
• Failure of a network data coupling (serial cable/connectors/wireless connections) will result in loss of data transfer.
• If the time and date settings are lost while in Programmed Activation Mode, the device will revert to Spot Check Activation Mode.
• All parts and accessories connected to the serial port of this device must be certified according to at least IEC Standard EN 60950,
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.
nonin.com
©2023 Nonin Medical, Inc. All trademarks are the property of Nonin Medical, Inc. unless otherwise noted.
Model 3150
Instructions for Use
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.
• Carboxyhemoglobin
• Methemoglobin DUT – Vertalingen van de handleiding zijn te vinden met behulp van deze QR-code.
• Dysfunctional hemoglobin
GRK – Με τη χρήση αυτού του κωδικού QR μπορείτε να βρείτε μεταφράσεις
• Artificial nails or fingernail polish
των οδηγιών χρήσης (IFU).
• Residue (e.g., dried blood, dirt, grease, oil)
DAN – Scan denne QR-kode for at finde oversættelser af denne brugsvejledning.
in the light path
SWE – Översättningar av den här guiden kan hittas med denna QR-kod.
F IN – Käyttöohjeen käännökset löytyvät tällä QR-koodilla.
POL – Tłumaczenia tego przewodnika można znaleźć za pomocą tego kodu QR.
NOR – Oversettelser av denne bruksanvisningen kan finnes ved å bruke denne QR-koden.
Warranty
The device warranty
is 3 years.
nonin.com/warranty
For summary of safety and clinical data see above QR code.
EC REP
P/N 114989-001-01 03/2023
Instructions for Use / Operator's Manual
https://www.nonin.com/support/wristworn
Symbol Compliance
Glossary
This product complies
with ISO 10993.
nonin.com/symbols
Not made from
natural rubber latex.
MPS, Medical Product Service GmbH MedEnvoy Switzerland
CH REP
Borngasse 20 Gotthardstrasse 28, 6302 Zug
D-35619 Braunfels, Germany Switzerland
13700 1st Avenue North, Plymouth, MN 55441-5443 USA nonin.com