iProven OXI-27 User manual

Battery
%SpO2 or oxygen saturation
Pulse rate per minute
Pulse rate intensity graph
Power button
Battery compartment
What’s in the box?
Intended use
Components of the device
How to increase oxygen saturation in a
natural way?
What is oxygen saturation?
How to take a measurement
Please note
FAQ
• Oximeter iProvèn OXI-27
• Two AAA-batteries
• Lanyard
• Oximeter case
The iProvèn Fingertip Pulse Oximeter is a digital monitor that
measures the level of oxygen saturation of haemoglobin in the arterial
blood. The monitor detects signs of low levels of oxygen in the body.
It measures the pulse rate in beats per minute, and also displays a bar
graph that illustrates the strength of the pulse signal.
The OXI-27 is intended for use on children above four years old and
adults whose weight is be between 15kg and 110kg.
The device should be used in the home/domestic setting only, and is
not intended for continuous monitoring.
This device is intended for non-invasive measuring and monitoring of
the oxygen saturation of haemoglobin in arterial blood and the pulse
rate in beats per minute.
• Measurements may be inaccurate in the following situations:
• When you’re moving your ngers
• In a very cold environment
• When your nger isn’t placed properly into the device (see
above)
• Excessive ambient light, such as a uorescent lamp or direct
sunlight, may aect the result
• Enamel or acrylic ngernail polish or other ngernail applications
may give inaccurate readings
• For sport and aviation use only
Q: How do I clean the device?
A: You can use medical alcohol to disinfect it. Please use a soft cloth to
clean the whole unit. Don’t use any abrasive or volatile cleaners.
Q: How can I replace the batteries?
A: Open the battery cover.
Insert the batteries according to the polarity indications.
Close the battery cover
Q: When do I replace the batteries?
A: - Low battery sign shows on the display.
- The LED display dims.
- When powering on the monitor, the LED display doesn’t light up.
Q: How do I attach the lanyard?
A: Put the thin end of the rope through the hole.
Then put the thick end of the rope through the loop, and pull the end to
secure it.
1. Open the clip and place your nger inside the oximeter. Make
sure your nail touches the upper part of the clip, see image
2. Press the button and wait for 10 seconds
3. Read your saturation level and heart rate from the display
1. Try to breathe more slowly and more deeply. In through the nose,
out through the mouth. Guess you heard that before. But being
aware of your respiration can already improve its quality!
2. Add green to your world! Consider buying some (extra) plants. Open
your window more often. Take a walk in the park. Being in the green
can improve your oxygen levels. It will also help you to feel more
relaxed. Which will help you to breathe more deeply, and as said,
that can also improve your oxygen levels!
3. Stay hydrated! The O in H2O stands for the oxygen molecules in
water. So drinking water will help to keep your oxygen levels up.
Hydrating yourself has quite a few extra benets. It can help to ght
fatigue. It may keep a headache away. And it can even help you to
lose weight
Oxygen saturation indicates how much oxygen the blood is carrying
as a percentage of the maximum it could carry. Red blood cells
contain iron-containing protein haemoglobin. Haemoglobin (hb)
attaches oxygen to the red blood cell and carries it through the body.
1 haemoglobin molecule can attach up to 4 oxygen molecules. If all
the haemoglobin molecules are carrying 4 oxygen molecules, it is said
that you have a saturation of 100%. A healthy person with healthy
lungs, breathing air at sea level, will have an oxygen saturation of
between 95% and 100%.
iProvèn OXI-27BLU
Manual ver 1.0 US
Warehouse
9450 SW Gemini DR
Beaverton, Or 97008-7105
Call us toll free if you have any questions or concerns.
[phone]
O2
O2
“Oh 2, you’re
breathtaking!”
O2O2
O2
O2
O2
O2O2O2
O2
Professional Care Brought Home

CAUTION
Technical Specications
Measurement principle
Extra notes on the device
Symbols Description
Error messages Warranty
EMC Guidance
• This device is not intended for use on extremities other than the ngertip.
• Do not confuse self-monitoring with self-diagnosis. Do not begin or end
medical treatment without asking a physician for treatment advice.
• If you are taking medication, consult your physician to determine the most
appropriate time to measure the oxygen levels in your body and pulse rate.
Never change a prescribed medication without consulting your physician.
• The user must check that the equipment functions safely and see that it is in
proper working order before use.
• Avoid shaking and collisions.
• If you have any problems with this device, such as setup, maintenance, or use,
please contact customer support. Don’t open or repair the device by yourself.
• Please report to iProvèn if any unexpected operations or events occur.
• Place the device in a dry environment. Avoid sunlight and do not immerse in
water. Also avoid dusty environments and unstable temperatures. All of these
factors can impact and reduce the performance and lifetime of the device.
• Make sure children do not use the device unsupervised.
The ngertip pulse oximeter contains a microprocessor and a display. The display
shows the oxygen saturation, the pulse rate and the intensity of your heart beat.
The display continuously gives information about the level of oxygen in your body
and your pulse rate per minute. The monitor updates its calculations regularly
during use to show immediate readings. The monitor starts to beep if the value
of the oxygen saturation 94% or lower. It will also beep when your heartbeat is
below 50 or above 130.
(Infra)red Signal Transmitter
(Infra)red Signal Detector
Display format
The Pulse Oxygen Saturation (SpO2)
Pulse Rate (PR)
Pulse intensity (bar-graph)
The SpO2 and Pulse
Rate cannot be
displayed normally
The SpO2 and
Pulse Rate are not
displayed constantly
The device cannot
be turned on
The display is o
suddenly
1) The nger is not
positioned properly
2) The user’s SpO2 is too
low to be detected
3) Poor blood circulation
in ngers
1) The nger is not placed
inside deep enough
2) The nger is shaking or
the user is moving
1) The batteries are low,
or there are no batteries
in the device
2) The batteries are not
inserted properly
3) The device does not
work properly
1) The device powers o
automatically when there
is no signal within 16
seconds
2) The batteries are low
1) Place the nger properly
and try again
2) Try again; consult your
doctor if you are sure the
device works correctly
3) Move your ngers to
stimulate blood circulation
1) Place the nger properly
and try again
2) Try to calm down and stop
moving your nger
1) Change batteries
2) Reinstall batteries
3) Contact customer support
via www.iproven.com
1) This is normal
Measuring range
Accuracy
Dimensions
Weight
Measuring range
Accuracy
Range
2x 1.5V (AAA size) alkaline battery
Smaller than 35 mA
Two batteries can work continuously for 24 hours
The ngertip pulse oximeter can be powered o in case no nger is placed within
the device for 16 seconds.
Red light (wavelength is 660nm)
Infrared (wavelength is 905nm)
Display information
Guidance and manufacturer’s declaration — electromagnetic emission
Emission test Compliance Electromagnetic environment — guidance
Problem Possible reason Solution
SpO2 Parameter Specication
Dimensions and Weight
Pulse Parameter Specication
Pulse Intensity
Battery requirement
Power Consumption
Battery Life
Power o
Optical Sensor
LED display
Digital
Dihgital
Digital bar-graph display
The iProvèn OXI-27 is intended for use in the electromagnetic environment
specied below. The customer of the user of the iProvèn OXI-27 should assure
that it is used in such an environment.
RF emissions CISPR 11
RF emission CISPR 11
Group 1
Class B
The OXI-27 uses RF energy only for its
internal function. Therefore, its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.
The OXI-27 is suitable for use in all establis-
hments, including domestic establishments
and those directly connected to the public
low-voltage power supply network that sup-
plies buildings used for domestic purposes.
35%-100% (resolution is 1%)
70%-100%; +/-2%
Below 70%; unspecied
62 (L) x 37 (W) x 32 (H) mm
About 50 gram with the batteries
25bpm-250bpm (resolution is 1bpm)
+/-2bpm
Continuous bar-graph display; the
higher the bar on the display, the
stronger the pulse
This device is subject to Limited Warranty. This covers any defects in materials or
workmanship under normal use during the Warranty Period. iProvèn will either
replace the product or repair the product at no charge, using new or refurbished
replacement parts. The Warranty Period of this iProvèn product is 2 years from the
date of purchase. A replacement product or product part assumes the remaining
warranty of the original product purchase. This Limited Warranty does not cover
batteries and packaging, nor any problem that is caused by conditions, malfuncti-
ons, or damage not resulting from defects in material or workmanship.
To obtain warranty service, contact our customer support at www.iproven.com to
determine the problem and the most appropriate solution for your situation.
iProvèn owns and reserves the rights comprised in the copyright of this
document. No part of this document may be changed, copied, reproduced, or
imitated in any form or by any means without the prior written consent of iProvèn.
All statements, information, and recommendations in this document are provided
“AS IS” without warranties, guarantees or representations of any kind, either
express or implied. The information in this document is subject to change without
notice. iProvèn reserves the right of nal interpretation of this document.
1. Remove batteries if the device is not likely to be used for some time.
2. Worn batteries are harmful to the environment. Do not dispose with daily
garbage.
3. Remove the old batteries from the device following your local recycling
guidelines.
4. Do not dispose of batteries in re. Batteries may explode or leak.
5. The operator should not touch output of batteries /adapter and the
user simultaneously. To avoid measurement errors, please avoid strong
electromagnetic elds, radiated interference signal, or electrical fast transient/
burst signal.
Type BF applied part
Attention must be paid
%SpO2 The Pulse Oxygen saturation (%)
/min Pulse rate (beats per minute)
The battery voltage indication is decient (change the
battery in time to avoid inexact measurements)
1. No nger inserted
2. An indicator of signal inadequacy
Waste electrical materials should be sent to a dedica-
ted collection point for recycling
IP22 anti-dust and anti-water class
PulseOximeter JPD-500E
IssuingDate:July,2017ManualVersion:1.0
InstructionstoUser
Dearusers,thankyouverymuchforpurchasingthePulseOximeter.
ThisManualiswrittenandcompiledinaccordancewiththecouncildirective
MDD93/42/EECformedicaldevicesandharmonizedstandards.Incaseof
modificationsandsoftwareupgrades,theinformationcontainedinthis
documentissubjecttochangewithoutnotice.
PleasereadtheUserManualcarefullybeforeusingthisproduct.
WARNING:
■Uncomfortableorpainfulfeelingmayappearifusingthedevice
ceaselessly,especiallyforthemicrocirculationbarrierpatient.Itis
recommendedthatthesensorshouldnotbeappliedtothesamefingerfor
over2hours.
■Thelight(theinfraredisinvisible)emittedfromthedeviceisharmfulto
theeyes,sotheuserandthemaintenancemanshouldnotstareatthe
light.
■EnamelorAcrylicfingernailpolishorotherfingernailapplicationsmay
distortand/orproduceinaccuratereadings.
■Pleaserefertothecorrelativeliteratureabouttheclinicalrestrictions
andcaution.
■Thisdeviceisnotintendedfortreatment.
1Safety
1.1InstructionsforSafeOperations
■
Checkthemainunitandallaccessoriesperiodicallytomakesurethat
thereisnovisibledamagethatmayaffectpatient
’ssafetyandmonitoring
performanceaboutcableandtransducers.Itisrecommendedthatthe
deviceshouldbeinspectedonceaweekatleast.Whenthereisobvious
damage,stopusingthemonitor.
■
Necessarymaintenancemustbeperformedbyqualifiedservice
engineersONLY.Usersarenotpermittedtomaintainitbythemselves.
■
TheoximetercannotbeusedtogetherwithdevicesnotspecifiedinUser
Manual.Onlytheaccessorythatappointedorrecommen
datoryby
manufacturecanbeusedwiththisdevice.
■
Thisproductiscalibratedbeforeleavingfactory.
1.2Warning
■
Explosivehazard---DONOTusetheoximeterinenvironmentwith
inflammablegassuchassomeignitableanestheticagents.
■
DONOTusetheoximeterwhiletheuserismeasuredbyMRIandCT.
■
Thepersonwhoisallergictorubbercannotusethisdevice.
■
Thedisposalofscrapinstrumentanditsaccessoriesandpacking
(includingbattery,plasticbags,foamsandpaperboxes)shouldfoll
owthe
locallawsandregulations.
■
Pleasecheckthepackingbeforeusetomakesurethedeviceand
accessoriesaretotallyinaccordancewiththepackinglist,orelsethe
devicemayhavethepossibilityofworkingabnormally.
1.3Attentions
●
Keeptheoximeterawayfromdust,vibration,corrosivesubstances,
explosivematerials,
hightemperatureandmoisture.
●
Iftheoximetergetswet,pleasestopoperatingit.
●
Whenitiscarriedfromcoldenvironmenttowarmorhumidenvironment,
pleasedonotus
eitimmediately.
●Hightemperatureorhighpressuresteamdisinfectionoftheoximeteris
notpermitted.RefertoUserManualintherelativechapterforinstructions
ofcleaninganddisinfection.
●Donothavetheoximeterimmergedinliquid.Whenitneedscleaning,
pleasewipeitssurfacewithmedicalalcoholbysoftmaterial.Donotspray
anyliquidonthedevicedirectly.
●Donotusethedeviceoninfantorneonatalpatients.
●Theproductissuitableforchildrenabovefouryearsoldand
adults(Weightshouldbebetween15kgto110kg).
●Thedevicemaynotworkforallpatients.Ifyouareunabletoachievestable
readings,discontinueuse.
●Theupdateperiodofdataislessthan5seconds,whichischangeable
accordingtodifferentindividualpulserate.
●Thedevicehasnormalusefullifeforfiveyearssincethefirstelectrifieduse.
●Theinstrumentdoesnothavelow-voltagealarmfunction,itonlyshowsthe
low-voltage,pleasechangethebatterywhenthebatteryenergyisusedout.
●Theinstrumentdoesnothavealarmfunction.Donotusethedevicein
situationswherealarmarerequired.
●Batteriesmustberemovedifthedeviceisgoingtobestoredformorethan
oncemonth,orelsebatteriesmayleak.
1.4Indicationforuse
TheFingertipPulseOximeterisanon-invasivedeviceintendedforthe
spot-checkofoxygensaturationofarterialhemoglobin(SpO2)andthepulse
rateofadultandpediatricpatientsinhomeandhospitalenvironments(including
clinicaluseininternist/surgery,anesthesia,intensivecareect.).Thisdeviceis
notintendedforcontinuousmonitoring.
2Overview
ThepulseoxygensaturationisthepercentageofHbO2inthetotalHbinthe
blood,so-calledtheO2concentrationintheblood.Itisanimportant
bio-parameterfortherespiration.ForthepurposeofmeasuringtheSpO2more
easilyandaccurately,ourcompanydevelopedthePulseOximeter.Atthesame
time,thedevicecanmeasurethepulseratesimultaneously.
ThePulseOximeterfeaturesinsmallvolume,lowpowerconsumption,
convenientoperationandbeingportable.Itisonlynecessaryforpatienttoput
oneofhisfingersintoafingertipphotoelectricsensorfordiagnosis,anda
displayscreenwilldirectlyshowmeasuredvaluedofHemoglobinSaturation.
2.1Classification:
ClassIIb(MDD93/42/EECIXRule10)
ClassII(U.S.FDA)
2.2Feature
■Operationoftheproductissimpleandconvenient.
■Theproductissmallinvolume,lightinweight(totalweightisabout50g
includingbatteries)andconvenientincarrying.
■Powerconsumptionoftheproductislow.
■Theproductwillautomaticallybepoweredoffwhennosignalisinthe
productwithin16seconds.
2.3MajorApplicationsandScopeofApplication
ThePulseOximetercanbeusedtomeasurehumanHemoglobinSaturation
andpulseratethroughfinger,andindicatethepulseintensitybythebar-display.
Theproductissuitableforuseinfamily,hospital(Ordinarysickroom),Oxygen
Bar,socialmedicalorganizationsandalsothemeasureofsaturationoxygen
andpulserate.
Theproductisnotsuitableforuseincontinuoussupervisionforpatients.
2.4EnvironmentRequirements
OperationTemperature:5℃-40℃
StorageTemperature:-10℃-50℃
AmbientHumidity:15%-80%RH,nocondensationinoperation
10%-93%RH,nocondensationinstorage
AtmosphericPressure:70kPato106kPa,inoperation
50kPa–106kPa,instorage
3PrincipleandCaution
3.1PrincipleofMeasurement
PrincipleoftheOximeterisasfollow:Anexperienceformulaofdataprocessis
establishedtakinguseofLambertBeerLawaccordingtoSpectrum
AbsorptionCharacteristicsofReductiveHemoglobin(Hb)and
Oxyhemoglobin(HbO2)inglow&near-infraredzones.Operationprincipleof
theinstrumentis:PhotoelectricOxyhemoglobininspectionTechnologyis
adoptedinaccordancewithCapacityPulseScanning&Recording
Technology,sothattwobeamsofdifferentwavelengthoflightscanbe
focusedontohumanfingertipthroughperspectiveclampfinger-typesensor.
Thenmeasuredsignalcanbeobtainedbyaphotosensitiveelement,
informationacquiredthroughwhichwillbeshowonscreenthrough
treatmentinelectroniccircuitsandmicroprocessor.
Figure1Operatingprinciple
3.2Caution
1.Thefingershouldbeplacedproperly(seetheattachedillustrationof
thismanual,Figure5),orelseitmaycauseinaccuratemeasurement.
2.TheSpO2sensorandphotoelectricreceivingtubeshouldbearrangedin
awaywiththesubject’sarterioleinapositiontherebetween.
3.Excessiveambientlightmayaffectthemeasuringresult.Itincludes
fluorescentlamp,dualrubylight,infraredheater,directsunlightandetc.
4.Strenuousactionofthesubjectorextremeelectrosurgicalinterference
mayalsoaffecttheaccuracy.
4Accessories
■Onehangingrope;
■Twobatteries(optional);
■OneUserManual.
5Installation
5.1ViewoftheFrontpanel
Figure2.FrontView
5.2Battery
Step1.RefertoFigure3.andinsertthetwoAAAsizebatteriesproperlyin
therightdirection.
Step2.Replacethecover.
Pleasetakecarewhenyouinsertthebatteriesfortheimproper
insertionmaydamagethedevice.
Figure3.BatteriesInstallation