Nonin 3230 Instructions For Use

Model 3230
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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3230 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% 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
Indications for Use/Intended Use/Intended Purpose
The NoninConnect Model 3230 Finger Pulse Oximeter is a small, lightweight, portable device indicated for use in
measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate of patients who
are well or poorly perfused. It is intended for spot-checking of adult and pediatric patients with digits between 0.8 – 2.5
cm (0.3 – 1.0 inch) thick.
NOTE: Use Environment—Home healthcare environments under the supervision of qualified medical professionals.
Users include current/potential users of pulse oximetry in the home and caregivers/potential caregivers of such a user.
P/N 115094-001-02 05/2023 13700 1st Avenue North, Plymouth, MN 55441-5443 USA
Warnings
• Do not use the device in an MR environment, in an explosive atmosphere, or on neonatal patients.
• This device is not defibrillation proof per IEC 60601-1.
• Use the Model 3230 within its designated range (approximately 10 m/32 ft, spherical radius, line of sight when connected to a Bluetooth Smart
Ready device). Moving outside this range may cause missing, lost, and/or inaccurate data.
• Inspect the sensor application site at least every 4 hours to ensure correct sensor alignment and skin integrity. Patient sensitivityto sensor may
vary due to medical status or skin condition.
• Avoid excessive pressure to the sensor application site as this may cause damage to the skin beneath the sensor.
• This device is intended only as an adjunct in patient assessment. It must be used in conjunction with other methods of assessing clinical signs
and symptoms.
• The device must be able to measure the pulse properly to obtain an accurate SpO2 measurement. Verify that nothing is hindering the pulse
measurement before relying on the SpO2 measurement.
• Operation of this device below the minimum amplitude of 0.3% modulation may cause inaccurate results.
• General operation of the device may be affected by the use of an electrosurgical unit (ESU).
• Keep the oximeter away from young children. Small items such as the battery door and battery are choking hazards.
• Before changing batteries, make sure the device is off and is not applied to a digit.
• Portable RF communications equipment such as cell phones or radios (including peripherals such as antenna cables and external antennas)
should be used no closer than 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
• This device has no audible alarms and is intended only for spot-checking.
• This device is designed to determine the percentage of arterial oxygen saturation of functional hemoglobin. Factors that may degrade pulse
oximeter performance or affect the accuracy of the measurement include the following:
• Excessive ambient light • Improperly applied sensor
• Incorrect sensor type
• Excessive motion
• 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
• The device may not work when circulation is reduced. Warm or rub the finger, or re-position the device.
• The device is designed to be attached only to a digit.
• This device's display will shut off after 30 seconds of no readings or poor readings.
• In some circumstances, the device will interpret motion as good pulse quality. Minimize patient motion as much as possible.
• Clean the device before applying it to a new patient.
• Do not sterilize, autoclave, or immerse this device in liquid. Do not pour or spray any liquids into the device.
• Do not use caustic or abrasive cleaning agents, or any cleaning products containing ammonium chloride or isopropyl alcohol.
• Do not use cleaning solutions other than those recommended here, as permanent damage could result.
• This device is a precision electronic instrument and must be repaired by Nonin Technical Service. Field repair of the device is not possible. Do
not attempt to open the case or repair the electronics. Opening the case may damage the device and void the warranty.
• This equipment complies with 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.
• When device is connected via Bluetooth, other Wi-Fi devices within 6 meters (20 feet) could interrupt the Bluetooth connection.
• Portable and mobile RF communications equipment including CT, diathermy, RFID, and electronic article security systems can affect medical
electrical equipment.
• Batteries may leak or explode if used or disposed of improperly. Remove batteries if the device will be stored for more than 30 days. Do not
use different types of batteries at the same time. Do not mix fully charged and partially charged batteries at the same time. These actions may
cause the batteries to leak.
• Follow local, state, and national governing ordinances and recycling instructions regarding disposal or recycling of the device and device 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.
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. U.S. Patents 10,624,583; D718,455; other patents pending.
Bluetooth is a registered trademark of Bluetooth SIG, Inc.
nonin.com
All trademarks are the property of Nonin Medical, Inc. unless otherwise noted.
Model 3230
Instructions for Use
ENG – Translations of the IFU can be found using this QR code.
• Carboxyhemoglobin
FRE – Les traductions de cette notice d'utilisation peuvent être retrouvées à l'aide de ce code QR.
• Methemoglobin
GER – Übersetzungen dieses Handbuchs können über diesen QR-Code abgerufen werden.
• Dysfunctional hemoglobin
• Artificial nails or fingernail polish
ITL – Utilizzando questo codice QR, è possibile trovare le traduzioni delle Istruzioni per l'uso.
• Residue (e.g., dried blood, dirt, grease, oil)
SPA – Las traducciones de este manual se pueden encontrar utilizando este código QR.
in the light path
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 – Με τη χρήση αυτού του κωδικού QR μπορείτε να βρείτε μεταφράσεις
των οδηγιών χρήσης (IFU).
DAN – Scan denne QR-kode for at finde oversættelser af denne brugsvejledning.
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 2 years.
nonin.com/warranty
For summary of safety and clinical data see above QR code.
EC REP
P/N 115094-001-02 05/2023
Instructions for Use / Operator's Manual
https://www.nonin.com/support/3230
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