W&H Osstell Beacon User manual

osstell.com
USER MANUAL
Osstell Beacon
US
US only

25087-05 US
3
Note!
Any serious incident that has occurred in relation to the medical device
should be reported to the manufacturer and the competent authority!
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
and disinfection procedure before attaching a new sleeve.
 Onlyusetheacceptablecleaninganddisinfectantuidslistedin
section 15 when cleaning and disinfecting the instrument. Using
notacceptablecleaninganddisinfectantuids,could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 14
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 use if the product sterile barrier system or
its packaging is compromised.
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.
Precautions:
To avoid interference with other equipment, the instrument should
not be held close to electronic devices.
Do not use the instrument in the presence of explosive or
ammablematerials.
See section 4, 5 and 10 for information about approved and com-
patible 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 maxillofacial 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
evaluation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 instru-
ment 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,typeA-C.
Your Osstell Beacon system includes the
following items:
1Osstell Beacon Instrument
2OsstellUSBcable,typeA-C
3Osstell SmartPeg Mount
4Osstell TestPeg
5Osstell Key
6Osstell Beacon User 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
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
Sterilizable up to 135 degrees Celsius
Temperature limitation
Humidity limitation
Atmospheric pressure limitation
IP20 Protected against solid foreign objects of 12.5mm Øand
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
Catalog Number
Do not reuse
Regulatory Compliance Mark (RCM) indicates compliance
with the Australian and New Zealand electrical safety, EMC,
EME and telecommunications requirements.
Medical device
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,typeA-C,towideendofthe
instrument. Connect the large USB connector to a standard USB type A
outlet 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,typeA-C.
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 indications are to be used only as visual
aid in what range the measured ISQ values are, where red is the lower
range, yellow is the middle range and green is the higher range of the
ISQscale.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2-4mm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 instru-
ment 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.
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-us.
• The Osstell Beacon instrument must be cleaned and disinfected with
 appropriatecleaninganddisinfectantuids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-us,
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 screw-
ing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(2-4mm)tothetopoftheSmartPegwithouttouchingit.
Hold the tip at approx. 45º angle towards the SmartPeg top as indicat-
ed 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.
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.

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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
7
approx. 45º
2-4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
stabilityoftheimplantisdependentofthesurroundingbonecong-
uration.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 meas-
urement 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. ISQ values have not been correlated with other methodes of
mobility measurements.
Note!Thenalimplanttreatmentdecisionsaretheresponsibilityofthe
clinician.
14) Data Connection to Osstell Connect
The Osstell Connect is an online service for data transfer, storage, display
and overview of your data.You can have your Osstell Beacon online
connected to Osstell Connect by the Osstell Key.
Before you can start using 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,pleasevisit:
osstell.com/get-started-beacon-us.
15) Cleaning and Maintenance
Aereachuse,followthebelowcleaninganddesinfectionprocedures.
Note! Do not autoclave the Osstell Beacon instrument.
Routinely check the surface of the instrument tip and overall surface for
possible cracks and residuals.
7,5 cm
Critical sites