Nonin 3230 User manual

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 – ΜετηχρήσηαυτούτουκωδικούQRμπορείτεναβρείτεμεταφράσεις
τωνοδηγιώνχρήσης(IFU).
DAN – ScandenneQR-kodeforatndeoversættelserafdennebrugsvejledning.
SWE – Översättningar av den här guiden kan hittas med denna QR-kod.
FIN – Käyttöohjeen käännökset löytyvät tällä QR-koodilla.
POL – TłumaczeniategoprzewodnikamożnaznaleźćzapomocątegokoduQR.
NOR – OversettelseravdennebruksanvisningenkannnesvedåbrukedenneQR-koden.
Instructions for Use / Operator’s Manual
P/N 115094-001-02 05/2023 13700 1st Avenue North, Plymouth, MN 55441-5443 USA nonin.com
Instructions for Use
Model 3230
REPEC
Warranty
The device warranty
is 2 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
• Do not use the device in an MR environment, in an explosive atmosphere, or on neonatal patients.
• Thisdeviceisnotdebrillation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specied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:
• Thedevicemaynotworkwhencirculationisreduced.Warmorrubthenger,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specied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.
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
• Bloodowrestrictors(arterialcatheters,
bloodpressurecuffs,infusionlines,etc.)
•Venous pulsations •Articialnailsorngernailpolish
•Anemia or low hemoglobin concentrations • Residue(e.g.,driedblood,dirt,grease,oil)
in the light path
•Moisture in the sensor •Cardiogreen and other intravascular dyes
P/N 115094-001-02 05/2023 13700 1st Avenue North, Plymouth, MN 55441-5443 USA nonin.com
Instructions for Use
Model 3230
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 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qualiedmedicalprofessionals.
Users include current/potential users of pulse oximetry in the home and caregivers/potential caregivers of such a user.
Contact Customer Service or Technical Service
Toll Free: 800.356.8874 (U.S.andCanadaonly)
Phone: [phone]
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-certiedmaterials,printedwithsoyink,andis100%recyclable.
For summary of safety and clinical data see above QR code.
3230 Specications
*Additionalspecications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
https://www.nonin.com/support/3230

To set up and use the Nonin Model 3230 pulse oximeter, please
follow the simple instructions below.
Instructions for Use
Model 3230
P/N 115094-001-02 05/2023 13700 1st Avenue North, Plymouth, MN 55441-5443 USA nonin.com
Installing AAA Batteries
1. Hold the 3230 so you see the back of the device and the arrows on the battery door point
away from you.
2. Place your thumbs on the ovals.
3. Slide the battery door away from you and off the 3230.
4. If applicable, remove the old batteries from the 3230. Properly dispose of the batteries.
5.Inserttwonew1.5voltAAA-sizebatteries.Carefullymatchthepolaritymarkings(+and-).
The 3230 will not work if the batteries are inserted the wrong way.
6. Carefully slide the battery door back onto the device.
P/N 115094-001-02 05/2023 13700 1st Avenue North, Plymouth, MN 55441-5443 USA nonin.com
Instructions for Use
Model 3230
Displays and Indicators
Please refer to the Operator’s Manual on nonin.com/support/3230
for troubleshooting guidance and more detailed operating instructions.
P/N 115094-001-02 05/2023 13700 1st Avenue North, Plymouth, MN 55441-5443 USA nonin.com
Instructions for Use
Model 3230
† These indicators only display when the associated feature has been activated by an integrator.
To Clean the NoninConnect Model 3230
Wipethedevicewithasoftclothdampenedwitha10%bleach/90%watersolution(householdbleach
[containinglessthan10%sodiumhypochlorite]).Donotuseundilutedbleachoranycleaningsolution
other than those recommended, 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.
Connection via Bluetooth Wireless Technology
WhentheModel3230isplacedonthengerandturnson,itisreadyforaBluetoothwireless
connection. The 3230 stays in this mode until it is shut off or the Bluetooth radio turns off. The symbol
iswhitewhentheBluetoothradioison,greenwhenthe3230isconnected,andasheswhenthereisa
communication error.
Clinical Benets
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.
For more information on the displays, indicators, and controls, please refer to the Operator’s
Manual.
Nonin’sCorrectCheck™sensesthatthengerhasnotbeencorrectlyinserted.Ifyouseethis
symbol,slidengerfurtherintodevice.
Thenumbernexttothissymbolistheamountofoxygeninyourblood(functionaloxygen
saturationofarterialhemoglobin).
The number next to this animated symbol is your pulse rate. Pulse rate is the number of times
your heart beats per minute.
Dashes replace the readings when the 3230 is unable to detect a usable signal.
White symbol – Radio is on.
Green symbol – 3230 is connected.
Flashing symbol – Connection error. The radio will reset.
No symbol – Radio is off.
Poorsignal.Steadyyourhand,repositionnger,warmngerbyrubbing,orselectadifferentnger.
Low battery. Replace batteries.
Critical battery. Flashing indicator on full screen. The device will not work until the batteries are
replaced.
† Spot-check complete. While Spot-check is in progress, a clockwise spinning circular icon
displays.
†Measurementcomplete(fullscreen).
Turning on the NoninConnect Model 3230
1. Insert a digit into the Model 3230 until it touches the built-in stop.
NOTE:Makesurethengeriscenteredwithinthengerguideandat(notonitsside).Forbest
results, keep the device at heart or chest level.
2. IftheCorrectCheckscreen(seeDisplaySymbolstable)displays,slidengerfurtherinto
device.Correctpositioningofthengeriscriticalforaccuratemeasurements.
3. The 3230 begins sensing the pulse and displaying readings.
4. View about 4 seconds of readings before relying on the displayed values. Continually verify
operation. It is common for the displayed values to vary slightly over a period of several
seconds. If the 3230 does not turn on or if it shuts off unexpectedly:
• Verify batteries are correctly inserted.
• If the batteries are depleted, replace batteries.
If the problem persists, remove the batteries and contact Nonin Technical Service.
NOTE:Whileonthenger,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.
IP32
IP32
IP32
IP32
MODEL 3230 OXIMETER
NONIN MEDICAL, INC.
PLYMOUTH, MN USA
IP32
R-NZ
1 2 3
5 6
WARNING:
Before changing batteries, make sure the device is off and is not applied to a digit.