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
https://www.nonin.com/support/8500
P/N 114855-001-01 11/2022 13700 1st Avenue North, Plymouth, MN 55441-5443 USA nonin.com
Instructions for Use
Model 8500
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
For summary of safety and clinical data see above QR code.
To set up and use the Nonin Model 8500 handheld pulse oximeter, please
follow the simple instructions below.
Install Batteries
Power On and Off
• TurnonthedevicebypressingtheON(|)button
• TurnoffthedevicebypressingtheOFF(Ø)button
The device automatically powers off after 10 minutes of inactivity.
Instructions for Use
Model 8500
P/N 114855-001-01 11/2022 13700 1st Avenue North, Plymouth, MN 55441-5443 USA nonin.com
The Model 8500 is powered by six AA-size alkaline batteries.
Insert the batteries as indicated inside the battery compartment.
Proper battery positioning is essential for correct operation.
When batteries are critically low, the digital displays will go blank
and the Pulse Quality Indicator will blink amber or red, but not green.
Connect the Sensor
Connect the pulse oximeter sensor with the Nonin logo
facing up to the top of the device as shown. Ensure the
sensorisrmlypluggedin.
Refer to sensor’s Instructions for Use for sensor
positioning information.
Taking Measurements
Verify the pulse oximeter sensor is properly positioned on the
patient. If the Pulse Quality Indicator is blinking red or amber
or is blinking erratically, reposition or replace the sensor. The
SpO2 and Pulse Rate readings will display a single dash until
a valid pulse signal is detected, which takes about 5 seconds.
Care and Maintenance
Clean the device separately from the sensors. For instructions
on cleaning sensors, refer to the respective instructions for use.
Clean the device with a soft cloth dampened with isopropyl
alcohol or a mild detergent. Do not pour or spray any liquids
onto the device, and do not allow any liquid to enter any
openings in the device. Allow the device to dry thoroughly
before reusing.
Pulse Rate
On Button
Off Button
% Oxygen
Saturation
Pulse Quality
Indicator
Advanced
Dimmer Button
Figure 1: Front View
Please refer to the Operator’s Manual on nonin.com/support/8500
for troubleshooting guidance and more detailed operating instructions.
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.
P/N 114855-001-01 11/2022 13700 1st Avenue North, Plymouth, MN 55441-5443 USA nonin.com
Instructions for Use
Model 8500
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
Nonin Model 8500 Handheld Pulse Oximeter is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin
(SpO2)andpulserateforadult,pediatric,andneonatalpatientsinhospitals,ambulatory,home,andEMSenvironments.Model8500isintended
for continuous monitoring and/or spot-checking of patients when attended by a healthcare professional.
Warnings
• Donotuseinanexplosiveatmosphereorinthepresenceofammableanestheticsorgasses.
• Do not use this device in an MR environment.
• ThisdeviceisnotdebrillationproofperIEC60601-1.
• 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.
• Inspect the sensor application site at least every 4 hours to ensure correct sensor alignment and skin integrity. Patient sensitivity to the sensor
may vary due to medical status or skin condition.
• Oximeterreadingsofthisdevicemaybeaffectedbytheuseofanelectrosurgicalunit(ESU).
• To avoid patient injury, use only with Nonin-branded PureLight® pulse oximeter sensors. These sensors are manufactured to meet the accuracy
specicationsforNoninPulseOximeters.Usingothermanufacturers’sensorscanresultinimproperpulseoximeterperformance.
• Topreventimproperperformanceand/orpatientinjury,verifycompatibilityofthemonitor,sensor(s),andaccessoriesbeforeuse.
• Nomodicationstothisdeviceareallowedasitmayaffectdeviceperformance.
• Do not use a damaged sensor. If the sensor is damaged in any way, discontinue use immediately and replace the sensor.
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.
8500 Specications
*AdditionalspecicationsareavailableintheOperator’sManualthatcanbelocatedusingtheQRCode.
• 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
Warnings (continued)
• As with all medical equipment, carefully route patient cabling to reduce the possibility of entanglement, strangulation, or injury to the patient.
• 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.
• Theuseofaccessories,sensors,andcablesotherthanthosespeciedinthePartsandAccessoriesListmayresultinincreased
electromagnetic emission and/or decreased immunity of this device.
• This 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.
• Discontinue use of adhesive tape strips if the patient exhibits an allergic reaction to the adhesive material.
• Avoid excessive pressure to the sensor application site as this may cause damage to the skin beneath the sensor.
• The device turns off after approximately 10 minutes when at critically low battery capacity.
• Before changing the batteries, make sure the device is off and the sensor is not applied to a digit.
• PortableRFcommunicationsequipmentsuchascellphonesorradios(includingperipheralssuchasantennacablesandexternal
antennas)shouldbeusednocloserthan30cm(12inches)toanypartoftheMEsystem,includingcablesspeciedbythemanufacturer.
Otherwise, degradation of the performance of this equipment could result.
Cautions
• Before use, carefully read the Instructions for Use provided with the sensors.
• Whenmountingthemonitortoamobilepole,mountingthemonitorhigherthan1.5meters(5feet)ormountingmorethan2kilograms
(4.5pounds)ofequipmentontothepolemayresultintipping,damagetotheequipment,orinjury.
• This device is not an apnea monitor.
• Verifythatallvisibleindicatorsilluminateduringthestartup(initialization)sequence.Ifanyindicatorisnotlit,donotusethedevice.
Contact Nonin Technical Service for assistance.
• Thepresenceofadebrillatormayinterferewiththeperformanceofthisdevice.
• This device may not work on all patients. If you are unable to achieve stable readings, discontinue use.
• 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. Minimize patient motion as much as possible.
• EarClipandReectancesensorsarenotrecommendedforpediatricorneonataluse.Theaccuracyofthesesensorshasnotbeen
established for pediatric or neonatal use.
• Do not autoclave or immerse the device or sensors in liquid. Do not expose the device or components to excessive moisture or liquids.
• Do not use caustic or abrasive cleaning agents on the device or the sensors.
• Theoximetersensormightnotworkoncoldextremitiesduetoreducedcirculation.Warmorrubthengertoincreasecirculation,or
reposition the sensor.
• Always replace the batteries with fully charged batteries. Do not use fully charged and partially charged batteries at the same time as this
may cause the batteries to leak.
• UseonlyNonin-speciedbatterytypeswiththisdevice.
• Do not remove any covers other than the battery cover when replacing batteries. There are no user-serviceable parts inside other than the
replaceable batteries.
• Follow local, state and national governing ordinances and recycling instructions regarding disposal or recycling of the device and device
components, including batteries.
• Batteries may leak or explode if used or disposed of improperly.
• Remove the batteries if the device will be stored for more than 1 month.
• 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 prolifera-
tion 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
specied.
• 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.
• A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor or sensor.
• AllpartsandaccessoriesconnectedtotheserialportofthisdevicemustbecertiedaccordingtoatleastIECStandardEN60950,IEC62368-1,
or UL1950 for data-processing equipment.
• This device is a precision electronic instrument and must be repaired by trained Nonin personnel only. 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.
• Anysignorevidenceofopeningthesystem,eldservicebynon-Noninpersonnel,tampering,oranykindofmisuseorabuseofthesystem,shall
void the warranty in its entirety.
• Failureofanetworkdatacoupling(serialcable/connectors)willresultinlossofdatatransfer.
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.
©2022 Nonin Medical, Inc. All trademarks are the property of Nonin Medical, Inc. unless otherwise noted.
• Excessive ambient light • Moisture in the sensor • Cardiogreen and other intravascular dyes
• Excessive motion • Improperly applied sensor • Carboxyhemoglobin
• Electrosurgical interference • Incorrect sensor type • Methemoglobin
• Bloodowrestrictors(arterialcatheters,
blood pressure - carboxyhemoglobin cuffs,
infusionlines,etc.)
• Inadequate signal • Dysfunctional hemoglobin
• Venous pulsations • Articialnailsorngernailpolish
• Anemia or low hemoglobin concentrations • Residue(e.g.,driedblood,dirt,grease,
oil)inthelightpath
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