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Cautions (continued)
• 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
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 electri-
cal equipment needs special precautions regarding EMC, and all equipment must be installed and put into service according to the
EMCinformationspecied.
• 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’s display will go blank after 10 seconds of inadequate signals. The data update period is every 1.5 seconds.
• 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:
• A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor or sensor.
• AllpartsandaccessoriesconnectedtotheserialportofthisdevicemustbecertiedaccordingtoatleastIEC60950orUL1950for
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.
• Replacebatterieswithin30secondstoavoidlosingsettings(date,time,andpatientdatastoredinmemory)orcorruptingdata.
• Radiosandcellphonesorsimilardevicescanaffecttheequipmentandmustbekeptatleast2meters(6.5feet)awayfromequipment.
• Failureofanetworkdatacoupling(serialcable/connectors/wirelessconnections)willresultinlossofdatatransfer.
Cautions – only for the Model 2500A PalmSAT Pulse Oximeter with Alarms
• Setting alarm limits to extremes can render the alarm system useless.
•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 •A sensor not at heart level
Nonin Model 2500C Charger Stand
Indications for Use/Intended Use/Intended Purpose
The Nonin Model 2500C Charger Stand is intended for use with the PalmSAT Models 2500 and 2500A Pulse Oximeters and the Model 2500B
RechargeableNiMH(NickelMetalHydride)BatteryPack.
Warnings
• Do not use this product in an MR environment.
• Do not use this product in an explosive atmosphere.
• ThisproductisnotdebrillationproofperIEC60601-1.
• As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement, strangulation, or injury to
the patient.
• This product should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the product should be
observed carefully to verify normal operation.
• The use of accessories, sensors, cables, and power supplies other than those listed in the Parts and Accessories List may result in increased
electromagnetic emission and/or decreased immunity of this product.
• Topreventimproperperformanceand/orpatientinjury,verifycompatibilityofthemonitor,sensor(s),andaccessoriesbeforeuse.
• Nomodicationstothisdeviceareallowedasitmayaffectdeviceperformance.
• PortableRFcommunicationsequipmentsuchascellphonesorradios(includingperipheralssuchasantennacablesandexternalantennas)
shouldbeusednocloserthan30cm(12inches)toanypartoftheMEsystem,includingcablesspeciedbythemanufacturer.Otherwise,
degradation of the performance of this equipment could result.
Cautions
• This equipment complies with International Standard 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 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 product. Medical electrical equipment needs special precautions regarding EMC, and all equipment must be installed and put into
serviceaccordingtotheEMCinformationspeciedinthismanual.
• Do not connect this product to an AC outlet controlled by a wall switch. If the switch is accidentally turned off before the battery pack is
recharged, the pulse oximeter may not function.
• Grounding reliability can only be achieved when the equipment is connected to an equivalent receptacle marked “Hospital Only” or “Hospital Grade”.
• This product contains sensitive electronic components and must be repaired by trained Nonin personnel only.
• Do not immerse this product in liquid.
• Do not place liquids on top of this product.
• Do not use caustic or abrasive cleaning agents on this product.
• Do not remove any covers from the product. There are no user-serviceable parts inside the unit.
• Do not attempt to charge disposable batteries. Disposable batteries may leak or explode if used improperly.
• Follow local, state and national governing ordinances and recycling instructions regarding disposal or recycling of the product and product com-
ponents, including batteries. Use only Nonin-approved battery packs.
• IncompliancewiththeEuropeanDirectiveonWasteElectricalandElectronicEquipment(WEEE)2002/96/EC,donotdisposeofthisproductas
unsorted municipal waste. This product contains WEEE materials; please contact your distributor regarding take-back or recycling of the prod-
uct. If you are unsure how to reach your distributor, please call Nonin for your distributor’s contact information.
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.
anddisplayingfunctionaloxygensaturationofarterialhemoglobin(SpO )andpulserateforadult,pediatric,andneonatalpatients.Thesedevices
Donotuseinanexplosiveatmosphereorinthepresenceofammableanestheticsorgasses.
• ThisdeviceisnotdebrillationproofperIEC60601-1.
• Oximeterreadingsofthisdevicemaybeaffectedbytheuseofanelectrosurgicalunit(ESU).
specicationsforNoninPulseOximeters.Usingothermanufacturers’sensorscanresultinimproperpulseoximeterperformance.
• Topreventimproperperformanceand/orpatientinjury,verifycompatibilityofthemonitor,sensor(s),andaccessoriesbeforeuse.
• Nomodicationstothisdeviceareallowedasitmayaffectdeviceperformance.
• Theuseofaccessories,sensors,cables,andpowersuppliesotherthanthosespeciedinthePartsandAccessoriesListmayresultinincreased
• PortableRFcommunicationsequipmentsuchascellphonesorradios(includingperipheralssuchasantennacablesandexternalantennas)
shouldbeusednocloserthan30cm(12inches)toanypartoftheMEsystem,includingcablesspeciedbythemanufacturer.Otherwise,
• Donotplacethisdeviceinanenvironmentwhereitsspeakeropeningmaybecomeblocked;alarmsmaybecomemufedorinaudible.
Verifythatallvisibleindicatorsilluminateandthatanaudibleindicatorsoundsduringthestartup(initialization)sequence.Ifanyindicatoris
Thepresenceofadebrillatormayinterferewiththeperformanceofthisdevice.
EarClipandReectancesensorsarenotrecommendedforpediatricorneonataluse.Theaccuracyofthesesensorshasnotbeenestablished
Theoximetersensormightnotworkoncoldextremitiesduetoreducedcirculation.Warmorrubthengertoincreasecirculation,orreposition
UseonlyNonin-speciedbatterytypeswiththisdevice.
withISO10993.
D-35619Braunfels,Germany