W&H Osstell Beacon User manual

osstell.com
USER MANUAL
Osstell Beacon
GB

25087-01 GB 3
2) Warnings and Precautions
Warnings:
Read all instructions before operating the Osstell Beacon.
 Theinstrumentemitsanalternatingmagneticeldthatpotentially
couldinterferewithcardiacpacemakers!Keeptheinstrumentaway
from implanted electronic devices. Do not place the instrument on
thepatient’sbody.
A transparent, barrier sleeve must be used to cover the Osstell
Beacon when used on patients. See section 11 for recommended
sleeves and section 15 for information on recommended cleaning.
 Onlyusetherecommendedcleaninguidslistedinsection15
whencleaningtheinstrument.Othercleaninguids,mayperma-
nentlydamagethedeviceenclosure.
Do not autoclave the instrument.
The SmartPeg Mount must be sterilized before use.
 Theinstrumentwillashred-yellow-greenduringstart-upasa
functionaltestofthecolorindication.Ifanyorallcolorsarenot
shown, the instrument must not be used. Contact the local sales
representative or distributor for further instructions.
 Alwaysperformameasurementintwodirections,Buccal-lingual
andMesial-Distal,asguidedbytheinstrument.Thisisimportantto
detectthelowestimplantstability.
Table of content
1) Table of content 3
2) Warnings and Precautions 3
3) Intended Use 4
4) Indications for Use 4
5) Description 5
6) SafetySymbols 6
7) Before You Start 7
8) Operation of the Osstell Beacon Instrument 7
9) TestPeg 7
10) SmartPeg 7
11) How to Measure 8
12) How to Measure on an Abutment 10
13) Interpret the Result 10
14) Data Connection to Osstell Connect 10
15) Cleaning and Maintenance 10
16) Technical information 12
17) Troubleshooting 13
18) Service and Support 15
19) Waste and Disposal 15
Welcome
CongratulationsonthepurchaseofyournewOsstell®Beacon.
BeforeyoustartusingyourOsstellBeacon,pleasereadthrough
the entire manual.

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 TheSmartPegs™aredisposableandshouldonlybeusedforone
or multiple measurements at one treatment session, for a single
patientonly(toavoidcross-contamination).Repeatedre-usemay
resultinfalsereadingsduetowearandtearofthesoaluminum
SmartPeg threads.
Do not expose the instrument to extreme high temp, e.g. leaving it in
thecardashboardonawarmsunnyday.
 TheOsstellBeaconisnotprotectedfromingressofuids,e.g.water,
attheUSBconnector(IP20classied).
Mains-operated power supplies or USB cable used for charging, shall
notbereachablebythepatient.
 Alwayschargetheinstrument,usingthesuppliedOsstellUSB-cable,
directlyconnectedtoa5VoltUSBtypeAport.
Splitter cables must never be used as these can lead to
permanent damage to the device.
Precautions:
To avoid interference with other equipment, the instrument should
not be held close to electronic devices.
 Onlyusetheacceptablecleaninguidslistedinsection15
when cleaning the instrument.
Do not use the instrument in the presence of explosive or
ammablematerials.
See section 4, 5 and 10 for information about approved and compat-
ible accessories.
3) Intended Use
OsstellBeaconisintendedforuseasaDentalImplantStabilityAnalyzer.
4) Indication for use
OsstellBeaconisindicatedforuseinmeasuringthestabilityofimplants
intheoralcavityandcraniofacialregion.
Conditions
Surgicallyplacedimplantsorabutmentsforwhichthereisspace
to attach a compatible SmartPeg.
Reasons for use
The Osstell Beacon can add important information to the evaluation of
implantstabilityandcanbeusedaspartofanoveralltreatmentevalua-
tionprogram.Thenalimplanttreatmentdecisionsaretheresponsibility
of the clinician.
Contraindications
OsstellBeaconiscontraindicatedforimplantsystemstowhichthe
SmartPegcouldnotbeattachedformechanicalincompatibilityreasons.
See section 10 for more information about SmartPegs.Osstell Beacon is
contraindicatedwhenusedtogetherwithPegsnotapprovedbyOsstell.
Osstell Beacon is contraindicated where it is not possible to attach the
SmartPegduetolackofspace,orwhereitimpingesonotherarticialor
anatomical structures.

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1 2 345 6
5) Description
The Osstell Beacon is a handheld instrument that involves the use
ofthenon-invasivetechnique,ResonanceFrequencyAnalysis.
ThesysteminvolvestheuseofaSmartPegattachedtothedental
implantorabutmentbymeansofanintegratedscrew.TheSmartPegis
excitedbyamagneticpulsefromtheinstrumenttip.
Theresonancefrequency,whichisthemeasureofimplantstability,
iscalculatedfromtheresponsesignal.Resultsaredisplayedonthe
instrumentastheImplantStabilityQuotient(ISQ).TheISQisscaledfrom
1to100.Itisameasurementofthestabilityoftheimplantandisderived
fromtheresonancefrequencyvalueobtainedfromtheSmartPeg.The
higherthenumber,thegreaterthestability.Theinstrumentsowarecan
beupdatedbyusingtheOsstellUSBcable.
YourOsstellBeaconsystemincludesthe
following items:
1Osstell Beacon Instrument
2Osstell USB cable
3Osstell SmartPeg Mount
4Osstell TestPeg
5OsstellKey
6Osstell Beacon Manual
AppliedParts:OsstellBeaconinstrumenttipandthinpartofbody.

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Caution
Follow instructions for use
Consult instructions for use
See section 2) Warnings and Precautions
TypeBFappliedpart
Manufacturer
YYYY-MM-DD
Date of manufacture
SN Serial number
Donotdisposeofwithdomesticwaste.Li-ionbattery.
CEmarkwithidenticationnumberofthenotiedbody.
ThiselectronicproductisapprovedbyFederal
CommunicationsComission(FCC)
FCCID:QOQBLE113IC:5123A-BGTBLE113
Non-ionizing electromagnetic radiation
Not Sterilizable
Temperature limitation
Humiditylimitation
Atmospheric pressure limitation
IP20 Protected against solid foreign objects of 12.5mm ∅ and
greater. No protection against water.
Usebydate
Lot/batch code
Sterilized using irradiation
RX-
Only
ForUSmarketonly:Prescriptionuseonly.U.S.FederalLaw
restrictsthisdevicetosalebyorontheorderofalicensed
practitioner
REF Catalog Number
2
Do not reuse
RegulatoryComplianceMark(RCM)indicatescompliance
withtheAustralianandNewZealandelectricalsafety,EMC,
EME and telecommunications requirements.
6)SafetySymbols

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7) Before You Start
TheOsstellBeaconisdeliveredfromfactoryina“transport”mode,
where the built-in motion sensor is deactivated.
To de-activate the transport mode and start charging, connect the small
USB connector of the Osstell USB cable to wide end of the instrument.
ConnectthelargeUSBconnectortoastandardUSBtypeAportofaPC,
laptop or charger.
The Osstell Beacon will start-up and enter charging mode. Charge the
Osstell Beacon for at least 3 hours or until the Osstell Beacon indicates
full charge. Remove the Osstell USB cable.
Note!ItisnotpossibletoperformanISQmeasurementduring
charging.
8) Operation of the Osstell Beacon
Instrument
TheOsstellBeaconisactivatedbyabuilt-inmotionsensor.Assoonas
the motion sensor detects movement, the Osstell Beacon will start-up,
ashred-yellow-greenandshortlyshowbatterystatusinthelower
displayandthenbereadyformeasurementintheBL(Buccal–Lingual)
direction,whichisindicatedintheupperdisplay.
TheOsstellBeaconwillstarttomeasure,indicatedbyanaudiblesound,
when near an Osstell Smartpeg or Testpeg due to a built-in magnetic
detector that senses the magnet on the top of the Osstell Smartpeg/
TestPeg.Measureddatawillbeshownintheupperdisplaycombined
with a colored light indication below the instrument tip.
Thered,yellowandgreencolorrepresentslow,mediumorhighimplant
stability.Aer60secondsofnomotion,theOsstellBeaconwillturno
automatically.
9) TestPeg
TheOsstellTestPegmaybeusedfortestingandlearninghowto
usethesystem.PlacetheOsstellTestPegonthetableorholditinyour
hand.ActivatetheOsstellBeaconbymovingitandholdtheinstrument
tipapproximately3-5mmawayfromthetopoftheOsstellTestPeg.The
OsstellBeaconshouldstarttomeasureandpresentanISQvalueof55
+/-2ISQ.
10) SmartPeg
TheSmartPegisavailablewithdierentconnectiongeometriestot
allmajorimplantproductsonthemarket.Youcanndallavailable
SmartPegs on osstell.com/smartpegguide.
TheSmartPegs™aredisposableandshouldonlybeusedforoneor
multiple measurement at one treatment session, for a single patient
only(toavoidcross-contamination).Repeatedre-usemayresultinfalse
readingsduetowearandtearofthesoaluminiumSmartPegthreads.

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11) How to Measure
Prior to use on a patient, place a barrier sleeve over the Osstell Beacon.
The barrier sleeve helps prevent cross-contamination and helps keep
dental composite material from adhering to the surface of the
instrumenttipandbody,anddiscolorationanddegradationsfrom
cleaning solutions.
Note:
•Barriersleevesaresinglepatientuseonly.
•Discardusedbarriersleevesinstandardwasteaereachpatient.
• Do not leave barrier sleeves on the instrument for extended periods.
• See below for recommended barrier sleeves.
Omnia: Non sterile cover, Art No 30.Z0600.00, Sterile cover Art No
22.Z0600.00. www.omniaspa.eu
TIDIshield, Art no: 21021, Art no: 20987. www.tidiproducts.com
PremiumPlus: 123, Small short 123, Small
Please also see additional recommended barrier sleeves on:
osstell.com/get-started-beacon
• The Osstell Beacon instrument must be cleaned and sanitized with
 appropriatecleaningand/orsanitizingagentsaereachpatient.
See section 15) Cleaning and Maintenance for acceptable agents.
Arstmeasurementshouldbetakenatimplantplacementtogeta
baseline for future measurements throughout the healing process.
Beforethenalrestoration,anothermeasurementistakenwhichmakes
itpossibletoobservethestabilitydevelopmentoftheimplant.
It is recommended to measure in both Buccal-Lingual and Mesial-
Distaldirectiontondtheloweststability.Therefore,theOsstellBeacon
prompts the user to measure in both these directions.
Werecommendyoustudyingthemoredetailedinformation(videosand
quick guides) available on osstell.com/get-started-beacon,
toutilizethefullfunctionalityofyourOsstellBeacon.
1.ActivatetheOsstellBeaconbypickingitup.Theinstrumentwill
start-upandaershowingthebatterystatus,theinstrumentwillbe
readyformeasurementintheBL(Buccal–Lingual)direction,whichis
promptedintheupperdisplayaswellasoptimalangleoftheinstru-
ment tip towards the Smartpeg.
2. Place a barrier sleeve over the Osstell Beacon instrument. See g 1.
3. Place the SmartPeg into the SmartPeg Mount. The SmartPeg is
magnetic, and the SmartPeg Mount will hold the SmartPeg. See g
2. AttachtheSmartPegtotheimplantorabutmentbyscrewingthe
SmartPegMountusingngerforceofapproximately4-6Ncm.
Do not over-tighten, to avoid damaging the SmartPeg threads.
4. Bring the instrument inside the mouth and hold the instrument tip
close(3-5mm)tothetopoftheSmartPegwithouttouchingit.
Hold the tip at approx. 45º angle towards the SmartPeg top as indicated
intheupperdisplayandshowning 3 and g 8a. Do not measure in
thewaysindicateding 8b or g 8c.
An audible sound indicates when measurement has started, and
measureddatawillbeshownintheupperdisplaycombinedwith
a colored light indication below the instrument tip. See g 4. Bring
theinstrumentoutofthemouthtoclearlyreadtheISQvalueandthe
colored indication.

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ThemeasuredISQvalueswillbedisplayedintheupperdisplayfora
coupleofsecondsandthenswitchtoindicatereadyformeasurement
in mesial-distal direction. See g 5.
Note! Donotbringtheinstrumentbackinthemouthuntilthedisplay
has switch to the next direction.
5. Repeat step 4 to measure in the mesial-distal direction, see g. 6,
andthenthesequencestartsoverandtheOsstellBeaconisreadyfor
measurementintheBL(Buccal-Lingual)directionagain.See g 7.
6. When measurements in both directions are performed, remove the
SmartPegbyusingtheSmartPegMount.
7.Theinstrumentisautomaticallyturnedoaer60secondsofno
motion.
8b
8a
8c
MD
2
1
6
3
BL
4
5
7approx. 45º
3-5 mm

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12) How to Measure on an Abutment
When a measurement is made on an abutment or on an implant with a
“built-in”abutment,theISQvaluewillbelowercomparedtoameasure-
mentmadeontheimplant.Thisisduetothedierenceinheightabove
bonelevel.TondouttheISQdierencetothemeasurementperformed
at implant level, a measurement should be taken on the implant before
the abutment is attached and then a second measurement on the
abutment.
13) Interpret the Result
Implant Stability
Animplantcanhavedierentstabilityindierentdirections.Thestabil-
ityoftheimplantisdependentofthesurroundingboneconguration.
Thereisoenadirectionwherethestabilityislowest,andadirection
wherethestabilityishighestandthesetwodirectionsaremostoen
perpendicular to each other.
Tondtheloweststability(lowestISQvalue)itisrecommendedto
measurefromtwodierentdirections.Theloweststabilityisinmost
cases found in the buccal-lingual direction. The highest
stabilityisinmostcasesfoundinthemesial-distaldirection.
The ISQ Value
Assumingthereisaccesstotheimplant,ISQmeasurementsshouldbe
performed at implant placement and before the implant is loaded or
theabutmentisconnected.Aereachmeasurement,theISQvaluesare
used as the baseline for the next measurement performed. A change
intheISQvaluereectsachangeinimplantstability.Ingeneral,an
increaseinISQvaluesfromonemeasurementtimetothenextindicates
aprogressiontowardshigherimplantstabilitywhileadecreaseinISQ
valuesindicatesalossinstabilityand,possibly,implantfailure.Astable
ISQvaluewouldindicatenochangeinstability.
14) Data Connection to Osstell Connect
The Osstell Connect (osstellconnect.com) is an online tool for statisti-
calanalysisandvaluableinsightsbasedonyourdata,withbenchmarks
againsttheentireOsstellConnectdatabase.YoucanhaveyourOsstell
Beacon online connected to Osstell Connect for data collection.
BeforeyoucanstartusingdataconnectiontoOsstellConnectyouhave
toregisteryourOsstellBeacon.Theserialnumbercanbefoundonthe
back of the instrument. For registration assistance and features of data
connection to Osstell Connect, please visit:
osstell.com/get-started-beacon
15) Cleaning and Maintenance
Beforeeachuse,moistenagauzeorsoclothwitharecommended
(seelistbelow)surfacecleanerandwipethewholeOsstellBeacon
instrument.
Note! Do not autoclave the Osstell Beacon instrument.
Routinelycheckthesurfaceoftheinstrumenttipandoverallsurfacefor
possible cracks and residuals.

25087-01 GB 11
Recommended Cleaners:
Isopropylalcohol
Lowfoaming,neutralpH,enzymaticdetergentslike:
Medizime LF
Enzol
Do not use:
Acidic or phenolic based cleaners/disinfectants.
Strongalkalidetergentofanytype,includinghandsoapsanddishsoaps
Bleach based cleaners
HydrogenPeroxidebasedcleaners
Abrasive cleaners
Acetoneofhydrocarbonbasedcleaners
MEK(MethylEthylKetone)
Birex
Gluteraldehyde
QuaternaryAmmoniumChloridesalt-basedcleaners
The instrument does not require regular maintenance. In the event of
an instrument malfunction, contact the local sales representative or
distributor for further instructions.
SmartPegs: Delivered sterile. The SmartPegs™ are disposable
andshouldonlybeusedforoneormultiple
measurements at one treatment session, for a single
patientonly(toavoidcross-contamination).
TestPeg: Isnotusedintra-orally,doesnotrequiresterilization.
The Smartpeg Mount should be cleaned and sterilized before each use
according to the instructions below.
SmartPeg Mount: Must be autoclaved according to the recom-
mendedsterilizationmethod,validatedtosterilityassurancelevels
(SAL),accordingtoISO17665-1andISO17664.TheSmartPegMount
should be placed in suitable packaging for the sterilization process.
Sterilization Exposure Exposure
Method: temperature time
Pre-vacuum 132°C(270°F) 4 min
Pre-vacuum 134°C(273°F) 3 min
Gravity 134°C(273°F) 10 min
Warnings:donotexceed135°C(275°F).Dryingtime:30minutes
CarefullyinspecttheSmartpegMountfordamageorwear.Hand
wash the Smartpeg Mount using a neutral instrument detergent.
Rinseanddry;carefullyinspecttheSmartpegMountfordamage
and wear. Sterilize the Smartpeg Mount according to the autoclave
manufacturer´s instructions. Do not wash in dishwasher.
Storesterilegoodsdust-freeanddry.

25087-01 GB12
16) Technical information
Technical description
OsstellBeaconisCE-markedaccordingtoMDDinEurope(ClassIIa,
internallypowered,typeBFappliedparts.NotAPorAPGequipment,
not protected against ingress of water).
Osstell Beacon is in accordance with applicable parts of IEC 60601-
1/ANSI/AAMI ES 60601-1.
Thesymbolsused,followtheEuropeanstandardEN60601-1andISO
standards 9687 and 15223 as far as possible.
Notes on electromagnetic compatibility (EMC)
Medical electrical equipment is subjected to particular precautions with
regards to EMC and must be put into operation in accordance with the
EMC notes included below:
Osstell guarantees the compliance of the device with the EMC require-
mentsonlywhenusedwithoriginalaccessoriesandspareparts.Theuse
of other accessories / other spare parts can lead to an increased emis-
sion of electromagnetic interference or to a reduced resistance against
electromagnetic interference.
YoucanndthecurrentEMCmanufacturer’sdeclarationonourwebsite
at osstell.com/products/Osstell-Beacon.
Alternatively,youcanobtainitdirectlyfromyourlocalsales
representative or distributor.
The Osstell Beacon contains a Bluetooth module.
FCCID:QOQBLE113,IC5123A-BGTBLE113
Battery
Theinstrumentcontainsarechargeablelithium-ionbattery.
TheinstrumentshouldbechargedusingtheOsstellUSBcabledirectly
connectedtoastandardUSB2.0or3.0,5VoltUSBtypeAport.Battery
statusandchargingisindicatedinthelowerdisplaywithabattery
symbolhaving4levels:100%(fullycharged),75%,50%andlessthan
25%.Whenthelevelislessthan10%,theOsstellBeaconwillchangethe
batterysymboltoalertthatitistimetochargetheinstrument.
Note!ItisnotpossibletoperformanISQmeasurementduring
charging.
Transport mode
Transportmodecanbeusedwhen,e.g.traveltodierentplacesoutside
theclinicandtherebyfrequentlymovetheOsstellBeacon,whichwill
wakeuptheinstrumentmorefrequentthanregularuseandthereby
drainingthebatteryfaster.
ThetransportmodeisactivatedbyconnectingtheOsstellUSBcable
(whenconnectedtoanUSBport)andremovingitwithin5secondsas
illustratedbyacount-downsequenceinthelowerdisplay.Thetwo
displayswillturndarkandtheinstrumentwillnolongerwakeupby
motion.
If the Osstell USB cable is not removed within these 5 seconds, the
instrument will enter charging mode.
To deactivate transport mode, connect the cable again, as is described
section 7.
Accuracy
TheOsstellBeaconinstrumenthasanISQaccuracy/resolutionof+/-1
ISQ.WhentheSmartPegisattachedtoanimplant,theISQvaluecan
varyupto2ISQdependingonSmartPegattachmenttorque.

25087-01 GB 13
Power, weight & size:
Lithium-ionbattery: 3.7VDC
Charging: UseonlyOsstellUSBcable(USBtypeC/USB
typeA)connectedtostandardUSB2.0or3.0
(typeA)port(Max5,2VDC).
Instrument size: 210 x 35 x 25 mm
Package size: 272 x 140,2 x 74,60 mm
Instrument weight: 0,07 kg
Gross weight: 0,75 kg
Environmental conditions during transport:
Temperature: -40º C to +70º C
Relativehumidity: 10%to95%
Pressure: 500 hPa to 1060 hPa
Environmental conditions during use:
Temperature: +10º C to +35º C
Relativehumidity: 30%to75%
Pressure: 700 hPa to 1060 hPa
IP class: IP20
17) Troubleshooting
No measurement or unexpected value
Re-Used SmartPeg.
TheSmartPegs™aredisposableandshouldonlybeusedforoneor
multiple measurement at one treatment session, for a single patient
only.Repeatedre-usemayresultinfalsereadingsduetowearand
tearofthesoaluminiumSmartPegthreads.
Wrong SmartPeg type selected for the Implant.
See SmartPeg reference list, osstell.com/smartpegguide
Bone or so tissue in between SmartPeg and Implant.
Make sure to clean the Implant prosthetic connection before attach-
ing the SmartPeg.
Electromagnetic interference.
Remove the source of electromagnetic interference.
Instrument tip is held too far away from the SmartPeg.
Holdtheinstrumenttip3-5mmawayfromtheSmartPeg.
Instrument does not sense the SmartPeg, hence no
measurement.
Bring the instrument out of the mouth and then in the mouth again.
Trytomeasurewithapprox.45ºangletowardstheSmartPegtopas
indicatedintheupperdisplay.

25087-01 GB14
Unit is not charging when USB cable is connected
Wrong USB cable used.
OnlyuseOsstellUSBcableconnectedtoastandardUSB2.0or3.0
(typeA)port(Max5,2VDC).
Instrument does not start
Uncharged battery.
Charge the Osstell Beacon.
Instrument in transport mode.
See section 7 for instruction on how to de-activate transport mode.
Instrument starts up with
Self-tests failed
Contact the local sales representative or distributor for further
instructions.
The instrument does not show red-green-yellow color
during start-upn
Theinstrumentwillashred-yellow-greenduringstart-upasa
functionaltestofthecolorindication.Ifanyorallcolorsarenot
shown, the instrument must not be used. Contact the local sales
representative or distributor for further instructions.
Diicult to measure in an exact recommended directionn
No space, e.g. due to adjacent teeth.
Trytomeasureataslightlydierentangle.
Diiculties attaching the SmartPeg
Wrong SmartPeg
EnsurethattheSmartPegiscompatiblewiththeimplantsystem.
See osstell.com/smartpegguide

25087-01 GB 15
18) Service and Support
In the event of an instrument malfunction contact the local sales repre-
sentative or distributor for further instructions.
19) Waste and Disposal
TheOsstellBeaconinstrumentshouldberecycledaselectricalequip-
ment.SmartPegsshouldberecycledasmetal.Wheneverpossible,the
batteryshouldbedisposedinadischargedstatetoavoidheatgenera-
tion through inadvertent short-circuiting.
Followyourlocalandcountry-speciclaws,directives,standardsand
guidelines for disposal.
• Waste electrical equipment
• Accessories and spare parts
• Packaging

Osstell AB
Stampgatan 14, 411 01 Göteborg, Sweden
Phone: [phone] | [email protected]om
www.osstell.com
Osstell AB Date of issue: 2019-05-03 25087-01 GB OSSTELL Beacon USER MANUAL

osstell.com
使用說明書
植體穩固度檢測儀
ATZH

25087-01 ATZH 3
2) 警告與注意事項
警告：
操作植體穩固度檢測儀前請仔細閱讀說明書。
此器械發出的互動式磁場可能對心臟節律調節器產
生潛在干擾！為避免受到其他設備的干擾，此器械不
應貼近植入電子設備。請不要將此器械放置於患者身
上。
患者使用時，必須使用透明的隔離套覆蓋在植體穩固
度檢測儀上。相關資訊，請參閱第11部分：套管和第
15部分：建議清潔資訊。
清潔儀器時，只能使用第15節中列出的推薦清潔液。
其他清潔液可能會對儀器外殼造成永久性損壞。
請勿使用高壓蒸汽滅菌器對器械進行滅菌。
在使用前必須保證感應器支架是無菌的。
啟動時，器械將閃爍紅-黃-綠作為顏色指示的功能測
試。如果沒有顯示任何顏色或所有顏色，請勿使用該
器械。請聯繫當地銷售代表或經銷商獲取更多指南。
在器械的指導下，通常對頰舌側和近遠側兩個方位進
行測量。這對於檢測最低的植體穩固度非常重要。
目錄
1) 目錄 3
2) 警告與注意事項 3
3) 預期用途 4
4) 適應症 4
5) 描述 5
6) 安全性標識 6
7) 運行前 7
8) 植體穩固度檢測儀的操作 7
9) 操作 7
10) 感應器 7
11) 測量 8
12) 支台齒測量 10
13) 結果解釋 10
14) 連接到電腦 10
15) 清潔和保養 10
16) 技術資訊 12
17) 故障排除 14
18) 服務和支援 15
19) 廢棄與處理 15
致謝
恭喜您購買植體穩固度檢測儀 (Osstell ® Beacon)！
在您開始使用植體穩固度檢測儀之前，請您仔細
閱讀本產品的使用說明書。

25087-01 ATZH 25087-01 ATZH45
感應器（SmartPegs™）為一次性使用產品或一次治療過
程中多次測量，多次測量的感應器僅能用於同一患者
（以避免交叉感染）。由於軟鋁材質感應器螺紋會有磨
損，所以重複使用可能導致錯誤的測量結果。
不要將器械暴露在極高的溫度下，例如在晴天時將器械
放置在汽車儀錶板上。
植體穩固度檢測儀無防止液體進入的防護措施，例如
水，在USB連接器（等級IP20）
患者不能接觸主機電源或用於充電的USB數據線。
充電時，請務必使用隨附的Osstell USB數據線，直接連
接到5 伏特 USB A型插槽。切勿使用分離器電纜，此電
纜將有可能導致儀器的永久性損害。
注意事項：
為了避免受到其他設備的干擾，此器械不應貼近電子設
備。
請勿在易爆或易燃材料下使用本器械。
相關批准和相容的產品附件資訊，請參見本說明書第4、第
5和第10部分。
3) 預期用途
植體穩固度檢測儀為牙科植體穩固度的分析器。
4) 適應症
植體穩固度檢測儀用於檢測口腔和顱面區域植入物的穩固度檢
測。
條件
外科植入的植體或支台齒間的空間附上可相容的感應器。
使用理由
植體穩固度檢測儀可以為植體穩固度評估提供重要資訊，可以
作為整體治療評估計畫的一部分。由臨床醫生負責植體治療的
最終決策。
禁忌症
植體穩固度檢測儀的禁忌包含：由於機械不相容性，感應器無
法連接到植體系統中。相關感應器的詳細資訊，請參見本說明
書第10部分。植體穩固度檢測儀禁止本產品與未經本公司批准
的感應器一起使用。植體穩固度檢測儀禁止由於空間不足無法
連接感應器，或感應器撞擊其他人造或解剖組織部位。
1 2 345 6
5) 描述
植體穩固度檢測儀（Osstell Beacon）是一種掌上型的檢測儀，
它使用無創技術以及牙科植體穩固度測量的共振頻率分析。該
檢測儀是將感應器（SmartPegs™)附著在植體或支台齒上。通
過掌上型檢測儀上的測量探針產生的磁脈衝來啟動感應器。通
過反應信號來計算共振頻率，該頻率用於測量植體穩固度。檢
測儀上的顯示結果為植體穩固度係數（ISQ），數值在1~100之
間。它是對植體穩固度的測量，由感應器獲得共振頻率匯出。
數值越高，表示穩固度越高。此器械軟體可以通過Osstell USB
數據線進行更新。
植體穩固度檢測儀（Osstell Beacon）包
含下列元件：
1 Osstell 植體穩固度檢測儀主機
2 Osstell USB數據線
3 Osstell 感應器支架
4 Osstell 檢測器
5 Osstell USB插頭
6 Osstell 植體穩固度檢測儀使用說明書
適用組件：Osstell植體穩固檢測儀尖端及機身較薄部分

25087-01 ATZH 25087-01 ATZH67
警告
遵循使用說明書
參見使用說明書
參見說明書第2) 部分：警告與注意事項
BF型設備
生產企業
YYYY-MM-DD 生產日期
SN 序號
請勿與生活垃圾一同處理。鋰電池
標有公告機構識別號的CE標誌
此電子產品已獲得聯邦通信委員會(FCC)的批准
FCC ID: QOQBLE113 IC: 5123A-BGTBLE113
非電離電磁輻射
禁止高溫滅菌
溫度限制
濕度限制
大氣壓力限制
IP20 防止固體異物：直徑為12.5mm或更大直徑的固體，
無防水
有效期限
批號/批次
使用輻照滅菌
RX-
Only 僅限美國市場：處方使用。美國聯邦法律限制這一
設備的銷售或僅能銷售給有執照的醫生
REF 產品型號
2
不得重複使用
法規符合性標誌（RCM）代表符合澳大利亞和紐西
蘭的電氣安全、EMC、EME和電信要求。
7) 運行前
植體穩固度檢測儀從工廠以“運輸”模式交付，其中內置的運
動感應器未被啟動。
要解除運輸模式並開始充電，將小型USB連接器插入到器械的
底部。連接大型USB連接器到標準 插槽 USB類型的個人電腦、
筆記型電腦或充電器上。
植體穩固度檢測儀將啟動並進入充電模式。植體穩固度檢測
儀充電至少3小時或直到此器械指示充滿為止，移除USB電源
線。
注意！在充電過程中不可執行ISQ測量。
8) 植體穩固度檢測儀
（Osstell Beacon）的操作
植體穩固度檢測儀由內置的運動感應器啟動，一旦運動感應器
檢測到活動，植體檢測儀將啟動，閃爍紅黃藍色，並在下方顯
示電池狀態，然後準備在BL（頰舌方位）測量。
當靠近植體穩固度檢測儀感應器或檢測器時，植體穩固度檢測
儀將開始測量（通過聲音指示），這是由於內置的磁性探測器
能夠感知Osstell感應器/檢測器頂部的磁鐵。測量資料將顯示在
上部顯示器中，並在器械尖端下方顯示彩色光進行指示。
紅色、黃色和綠色分別表示種植體穩固度低等、中等或高等。
停止移動60秒後，種植體穩固度檢測儀將自動關閉。
9) 檢測器（TestPeg）
Osstell檢測器可以用於測試和學習如何使用該系統。把Osstell檢
測器放在桌子上或拿在手中。本器械通過移動檢測器啟動，並
將器械尖端保持距離檢測器頂部約3-5mm。植體穩固度檢測儀
應該開始測量並顯示ISQ值為55+/-2ISQ。
10) 感應器（SmartPeg）
感應器有不同的幾何形狀連接，適用於市場上的所有主流植體
產品。您可以在osstell.com/smartpegguide網站上找到所有可用
的感應器。
感應器（SmartPegs™）為一次性使用產品，一次治療過程中多
次測量，多次測量的感應器僅能用於同一患者（以避免交叉感
染）。由於軟鋁材質感應器螺紋會有磨損，所以重複使用可能
導致錯誤的測量結果。
6) 安全性標識