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.

25087-01 GB4
 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.

25087-01 GB 5
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.

25087-01 GB6
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

25087-01 GB 7
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.

25087-01 GB8
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.

25087-01 GB 9
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

25087-01 GB10
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.