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25087-00 ML

2

2) Warnings and Precautions

Warnings:

  Read all instructions before operating the Osstell Beacon.

  The instrument emits an alternating magnetic field that poten

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tially could interfere with cardiac pacemakers! Keep the instru-

ment 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 recommend-

ed sleeves and section 15 for information on recommended 

cleaning.

  Do not autoclave the instrument.
  The SmartPeg Mount must be sterilized before use.

  The instrument will flash 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 impor-

tant to detect the lowest implant stability.

  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 

soft aluminum SmartPeg threads.

Table of content

1)  Table of content 

2

2)  Warnings and Precautions 

3

3)  Intended Use 

3

4)  Indications for Use 

3

5) Description 

3

6)  Safety Symbols 

4

7)  Before You Start 

5

8)  Operation of the Osstell Beacon Instrument 

5

9) TestPeg 

5

10)  SmartPeg  

11)  How to Measure 

12)  How to Measure on an Abutment 

7

13)  Interpret the Result 

7

14)  Data Connection to Osstell Connect 

8

15)  Cleaning and Maintenance 

8

16)  Technical information 

9

17) Troubleshooting 

10

18)  Service and Support 

11

19)  Waste and Disposal 

11

Welcome

 

Congratulations on the purchase of your new 

Osstell® Beacon.  Before you start using your Osstell 

Beacon, please read through the entire manual.

Summary of Contents for Beacon

Page 1: ...osstell com USER MANUAL Osstell Beacon GB ...

Page 2: ...rm a measurement in two directions Buccal lingual and Mesial Distal as guided by the instrument This is impor tant to detect the lowest implant stability 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 soft al...

Page 3: ...verall treatment evaluation program The final 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 ...

Page 4: ...lectronic 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 6 Safety Symbols 1 2 3 4 5 6 Your Osstell Beacon system includes the following items 1 Osstell Beacon Instrument 2 Osstell USB cable 3 Osstell SmartPeg Mount 4 Oss...

Page 5: ...acon 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 flash 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 aud...

Page 6: ...implant placement to get a baseline for future measurements throughout the healing process Before the final 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 find the lowest stability Therefore the Osstell Beacon prompts the user to measure in both t...

Page 7: ...ould 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 different stability in different directions The stability of the implant is dependent of the surrounding bone configuration There is often a direction where the stability is lowest and a direction where the stability is highest and...

Page 8: ...ze or soft cloth with an acceptable see list below surface disinfectant 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 Acceptable Cleaners Isopropyl alcohol Ethyl alcohol based cleaners Do not use Strongalkalidetergentofanytype includinghandsoaps...

Page 9: ...mbols 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 requirements only when use...

Page 10: ... 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 soft aluminium SmartPeg threads Wrong SmartPeg type selected for the Implant See SmartPeg ref...

Page 11: ...t the local sales representative or distributor for further instructions Difficult to measure in an exact recommended directionn No space e g due to adjacent teeth Try to measure at a slightly different angle Difficulties attaching the SmartPeg Wrong SmartPeg Ensure that the SmartPeg is compatible with the implant system 18 Service and Support In the event of an instrument malfunction contact the ...

Page 12: ...Osstell AB Stampgatan 14 411 01 Göteborg Sweden Phone 46 31 340 82 50 info osstell com www osstell com Osstell AB Date of issue 2018 05 25 25087 00 ML OSSTELL Beacon USER MANUAL ...

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