Forum Technologies Implant Locator User manual

Implant Locator
User Manual

IT ES FRENG 2-16 18-32 33-48 49-64

Introduction
1. Indications for use
2. Contraindications
3. Warnings
4. Precautions
5. Adverse Reactions
6. Step-by-Step Instructions
6.1. Packaging Box Content
6.2. Implant Locator outlook
6.3. Installing / Replacing the Battery
6.4. Getting Started
6.5. Device operation
6.6. Audio feedback
6.7. Automatic Shutdown
7. Maintenance, cleaning and sterilization
8. Troubleshooting
9. Warranty
10. Disclaimer
11. Certification
12. European Authorized Representative
13. Technical Specifications
14. Standard symbols
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Table of Contents
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6.5. Device operation
6.6. Audio feedback
6.7. Automatic Shutdown
7. Maintenance, cleaning and sterilization
8. Troubleshooting
9. Warranty
10. Disclaimer
11. Certification
12. European Authorized Representative
13. Technical Specifications
14. Standard symbols
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Congratulations, you have made a good
choice with Implant Locator – innovative
device for precise localization of implants
buried under gum tissue. Ergonomic user-
friendly design of Implant Locator makes it a
choice of preference in modern dental clinic.
Utilizing the advanced technology,
Implant Locator is a precise, user-friendly,
affordable device suitable both for skilled
implantologists and for general practitioners
working with implants.
Implant Locator
Pic.1
FOR DENTAL USE ONLY

4
Implant Locator is an electronic device used for localization of implants covered by gum tissue during two-stage implantology. The device enables to obtain
good results with various implant systems.
Implant Locator is not recommended for use in patients or by personnel having a pacemaker or other implanted electrical devices.
This product must only be used in hospital environments, clinics or dental offices by qualified dental personnel.
• Do not use Implant Locator near devices emitting electromagnetic noise such as uorescent lamps, lm viewers, ultrasonic devices, etc. Cellular phones, remote
controls or other devices generating electromagnetic waves may cause abnormal operation of Implant Locator. Such devices should be turned off.
• During device operation protect Implant Locator from occasional spillage of liquids.
• Do not use Implant Locator in presence of ammable materials.
• Implant Locator should be used with the manufacturer’s original accessories only.
• In order to prevent infectious agent transmission, the sensor should be changed or sterilized between patients.
• Presence of metallic bodies near the sensor may distort device indication. Avoid presence of metallic items in the vicinity of the sensor during device operation.
• For your own safety, please use personal protection gear (gloves, mask).
Indications for use
Contraindications
Warnings
Precautions
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None.
Adverse Reactions
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6.1. Packaging Box Content
6.2. Implant Locator outlook
Check the content of the packaging box before use:
• Implant Locator - 1 pc.
• AA alkaline battery - 1 pc.
• Sensor holder - 1 pc.
• Sensor - 1 pc.
• User Manual - 1 pc.
General view of Implant Locator is shown on Pic. 2.
Note: Sensor is an Applied Part of the device.
Step-by-Step Instructions6
Sensor
Sensor Holder
Handle
Protective Cap
LED Indicators
Holder lock button
On/Off button
Pic. 2

6
6.3. Installing / Replacing the Battery
6.4. Getting Started
Prior to battery replacement the device must be turned off.
Take care for correct polarity during battery insertion (”+” must be
towards the inner part of the battery compartment). Implant Locator
is protected against incorrect battery polarity. In case of polarity error,
remove the battery and reinsert it correctly.
Prior the first use and between the patients, the device and sensor
holder should be cleaned and disinfected using wipes moisturized
by disinfectant. The sensor should be cleaned and autoclaved as
described in §7.4
Implant Locator is powered by one 1.5V AA alkaline primary battery.
• Remove old battery from the battery compartment
• Insert new battery into the battery compartment according to the
marking on the device as shown on Pic. 4
• Screw in the battery cap and close the protective cap until click.
6.3.1. To install / replace the battery, remove the
protective cap and unscrew the battery cap Pic. 3.
Battery Cap
Protective Cap
Pic. 3 Pic. 4
+

6.4.1. Gently attach the sensor holder to the device as shown on Pic. 5. 6.4.2. Insert the sensor into the holder until stop as shown on Pic. 6.
For lower jaw implants For lower jaw implants For upper jaw implants
For upper jaw implants
Device configuration for lower jaw implants
Pic. 5 Pic. 6
Pic. 7
• To remove the sensor holder press the holder lock
button and gently pull the holder from the device.
6.4.3. Correct device configurations are shown on Pic. 7.
Device configuration for upper jaw implants 7

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6.4.4. Turn the device on by pressing the button. One short beep
indicates that audio feedback is enabled. To disable the audio feedback hold
the button pressed for about 1 sec.
After turning the device on, the battery status is checked. If the battery is
depleted, or at, 4 segments are ashing red 3 times accompanied by 3 beeps.
• In case of depleted battery the device may continue normal operation
before the battery is replaced.
• In case of at battery the device turns off and cannot operate before
battery replacement.
• If calibration error is detected, it is indicated by running orange segment. After 10 sec. the device turns off automatically.
To correct calibration error, turn the device off, check proper connection of the sensor holder and of the sensor. If required, replace the sensor. Verify that there are
no metallic objects in the vicinity of the sensor and turn the device on again.
Before starting device operation the self-test is performed
• If sensor holder is not properly connected to the device or sensor is not
inserted into the holder, the error is indicated by running red segment.
After 10 sec. the device turns off automatically.
To correct the error, turn the device off, connect the sensor holder, insert
the sensor until stop and turn the device on again.
After the self-test the device performs automatic calibration.
• Running green segment indicates calibration in progress. When calibration
is completed, 4 segments blink green indicating that
the device is ready for operation.
Pressing the button will restart automatic calibration cycle described above.
6.4.5. Battery check-up
6.4.6. Self-test and calibration.
Take care that no metallic object will be closer than
10 cm to the sensor.
Presence of metallic objects close to the sensor during self-test and calibration may prevent correct device operation or reduce precision of implant localization.

Pic. 9 9
6.5. Device operation
6.5.1. When Implant Locator is ready, 4 segments blink green (Pic. 8).
6.5.3. Implant localization
• When the sensor is approaching the implant, 4 segments turn steady green (Pic. 10a).
• Continue uent movement of the sensor in the same direction without stopping
until the segments turn orange indicating that the sensor has passed the
implant position (Pic. 10b).
• Reverse direction and slowly move the sensor back along the same path. Four
segments turn green again indicating sensor movement towards the implant
(Pic. 10c). Continue sensor movement in reverse direction without stopping.
• When the sensor returns to the implant position, 4 segments turn off and the
central dot turns green indicating detection of implant location (Pic. 10d). The
visual indication is accompanied by solid audio signal.
• Through the hole in the middle of the sensor mark on the gum location of the
implant using dental probe.
6.5.2. Insert the device into the mouth cavity and place the
sensor plane onto the gum at some distance from the estimated
position of the implant. The central hole of the sensor should be
approximately in the middle of the jaw ridge. Slowly move
the sensor along the jaw towards estimated position
of hidden implant (Pic. 9).
Pic. 8
To ensure correct measurements, take care that the sensor plane will
be always slightly pressed to the gum without gap.
Thick gum layer covering the implant may prevent correct implant
localization or reduce precision.

Pic. 10
The sensor movement should be smooth without
stopping or unnecessary reversing the direction of the
movement. This may cause incorrect readings.
Stopping sensor movement for more than 3 sec. before completing detection of implant
location is indicated (central green dot turns on) will cause automatic reset
(4 segments blink green). Implant localization should be repeated from the beginning.
10
A C D
B
Sensor is approaching
the implant
Continue in the same
direction
GREEN
Sensor has passed
the implant position
Reverse direction
ORANGE
Sensor moves back to
the implant position
Continue in the
reversed direction
GREEN
Detection of
implant location
GREEN DOT

6.5.4. Cross-scanning
• To improve the precision of implant localization it is possible to
perform additional cross-scanning in Buccal-Lingual direction as
shown schematically on Pic. 11.
6.5.5. Localization of multiple implants
In case of multiple implants, after locating and marking the first implant continue
to the estimated position of the next implant.
• Slowly move the sensor along the jaw ridge. The central dot will turn off and
4 segments will turn orange; then the segment will blink green indicating that
the Implant Locator is ready for detection of the next implant.
• Perform implant localization as described in § 6.5.3. and 6.5.4.
• After initial implant localization as shown on Pic. 10d slowly move the
sensor in Buccal-Lingual direction pressing it slightly to the gum. The
operating sequence is similar to the sequence described in § 6.5.3.
Pic. 11
Presence of metal crown, abutment, tooth with large amalgam
filling, metallic instrument close to the implant may prevent
correct implant localization or reduce precision.
Correct localization of implant position may be impossible when 2 or
more implants are too close.
6.6. Audio feedback
Implant Locator is equipped with an audio feedback which enables monitoring of
device operation additionally to visual indication. Audio feedback may be disabled
as described in s. 6.4. above.
6.7. Automatic Shutdown
Implant Locator automatically shuts down after 2 minutes without use. In order to
prolong the battery life, it is recommended to switch off the device after completing
implant localization by pressing the button and holding it for about 1 sec.
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Use of agents other than specified in this section may
cause damage to the equipment and its accessories.
No visible impurities should remain on the sensor holder after cleaning
and disinfection process.
The sensor is intended for 10 sterilization cycles maximum
Maintenance, cleaning and sterilization7
7.1. General
7.2. Device cleaning
7.4. Disinfection and sterilization procedure for sensor
7.3. Sensor holder cleaning and disinfection
• The device does not contain user serviceable parts. The service and
repair should be provided by factory trained service personnel only.
• All objects that were in contact with potentially infectious agents
should be cleaned and disinfected after each use.
Before the first use and between treatments the device should be
cleaned using tissue or soft cloth impregnated with aldehyde free
disinfecting and detergent solution (a bactericidal and fungicidal).
Before the first use and between treatments the Sensor should be disinfected and
sterilized by autoclaving as described below:
Before the first use and between treatments the sensor holder should
be separated from the device, cleaned and disinfected using tissue or
soft cloth impregnated with aldehyde free disinfecting and detergent
solution (a bactericidal and fungicidal).
Details and
Warnings
InstructionsOperation
No particular requirementsPreparation at the point of use
prior to processing
1
No particular requirementsPreparation for decon-
tamination/ preparation before
cleaning
2
The sensor is not intended for
automated cleaning
Cleaning: Automated3

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Details and WarningsInstructionsOperation
After cleaning no visible impurities should remain on the sensor, in particular
inside and near the central hole
Clean the sensor with an adequate brush or towel soaked in a
disinfectant solution
Cleaning: Manual4
- Follow instructions given by the disinfectant manufacturer
(concentration, immersion time, etc.)
- Do not use disinfectant solution containing aldehyde, phenol or any
products which may damage the items
- Soak the sensor in a disinfectant solution combined with
proteolytic enzyme if possible
- Rinse well the sensor in owing water
Disinfection5
No particular requirementsDrying6
- Sensors with damages or scratches on the coating or on the contacts must
be discarded
- Sensors with damages to the gold plating of the contacts or of the central
hole must be discarded
Visually inspect the sensor to detect possible damage to the
sensor coating or to the gold plating of the contacts and the
central hole
Maintenance, inspection and
testing of the sensor
7
- Check the validity period of the pouch given by the manufacturer to
determine the shelf life of the sterilized items.
- Use packaging which is resistant up to a temperature of 141°C (286°F)
Pack the sensor in sterilization pouchesPackaging8
- Follow maintenance and operation procedures of the autoclave provided
by the manufacturer
- The only sterilization parameters to be used are those that have been
validated and provided to the user in this User Manual
Steam sterilization at 134°C (273.2°F) during 18 minutes in
gravity type autoclave. (Table Top, N type)
Sterilization9
Sterility cannot be guaranteed if packaging is open or damaged (check the
packaging before using the sensors)
Keep sensors in sterilization packaging in a dry and clean
environment
Storage10

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SolutionPossible CauseProblem
1. Press the On/OFF button several times.
2. Replace the battery
3. Contact your customer service
1. Button malfunction
2. Flat battery
3. Electronic malfunction
The device does not turn on
by pressing On/Off button
1
Turn the device Off and then turn it On. One short beep indicates that audio
feedback is enabled
Audio feedback is disabledNo sound while measuring2
1. Turn the device Off, remove the sensor, clean contact surfaces of the
sensor and reinsert it. Turn the device On again
2. Replace the Sensor
3. Replace the Sensor holder
4. Contact your customer service
1. Sensor is disconnected
2. Damage to the Sensor, sensor coating or sensor contacts
3. Sensor holder is damaged; Bad contact
4. Electronic malfunction
Device cannot indicate the
location of the implant
3
Troubleshooting
Warranty
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Please review the suggested solutions before calling customer service.
Implant Locator is warranted for 24 months from the date of purchase. The accessories (sensor holder and battery) are warranted for 6 months from the date of
purchase. The warranty is valid for normal usage conditions. Any damage caused by accident, abuse, misuse, or as a result of service or modification other than by
a person authorized by the manufacturer will render the warranty void.
The warranty is in lieu of any other warranty expressed or implied. Sensors are disposable and are not covered by warranty.

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The manufacturer, its representatives and its dealers shall have no liability or
responsibility to customers or any other person or entity with respect to any
liability, loss or damage caused or alleged to be caused directly or indirectly by
equipment sold or furnished by us, including, but not limited to, any interruption
of service, loss of business or anticipatory profits, or consequential damages
resulting from the use or operation of the equipment.
The manufacturer reserves the right to implement changes and modifications
of the product at any time, to revise this publication and to make changes in
the contents hereof without obligation to notify any person of such changes,
modifications or revisions.
European Authorized Representative who has been
empowered to enter into commitments on our behalf:
EASYDENT
13 Place de la Nation 75011 Paris, France.
Tel. & Fax [phone]
R.C.S. Paris B 397 769 480 (94B09899)
Email: [email protected]
President: Iris BAT-GENSTEIN
Implant Locator complies with IEC 60601-1 (Safety) and IEC 60601-1-2
(Electromagnetic compatibility) standards, including conducted and radiated
immunity tests as specified for equipment of Group 1 Class B.
Disclaimer European Authorized Representative
Certification
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Implant Locator belongs to the following category of medical devices:
• Internally powered equipment
• Type B applied parts
• Not suitable for use in the presence of ammable anesthetic
mixtures with air, oxygen or nitrous oxide
• Continuous operation
• Ingress of liquids – not protected
• The device is intended for indoor use only
• Environmental conditions during storage/transportation:
- Temperature: -20 ºC to +60 ºC (-4 ºF to 140 ºF)
- Relative humidity: 10% to 90%, non-condensing
- Atmospheric pressure: 106 kPa to 19 kPa
• Operational ambient environmental conditions:
- Temperature 10 ºC to +40 ºC (50 ºF to 104 ºF)
- Relative humidity: 10% to 90%, non-condensing
- Atmospheric pressure: 106 kPa to 70 kPa
Device marking includes the following standard symbols:
Type B applied part
Direct current
Manufacturer
Recycling: PLEASE DO NOT THROW AWAY! This product and all its
components must be recycled through your supplier
Date of manufacture
Consult instructions for use
Implant Locator is intended for use in electromagnetic environment specified
for equipment of Group 1 Class B.
Specifications:
Dimensions: 215 x 45, dia. 21 mm
Weight: 60 gr.
Type of display: LED segments
Power source: 1 x 1.5V AA alkaline primary battery
Technical Specifications
Standard symbols
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Device label includes the following standard symbol:

Recycling: PLEASE DO NOT THROW AWAY! This product and all its
components must be recycled through your supplier
Specifications:
Dimensions: 215 x 45, dia. 21 mm
Weight: 60 gr.
Type of display: LED segments
Power source: 1 x 1.5V AA alkaline primary battery
IT 18-32
Manuale di istruzioni

1. Introduzione
2. Controindicazioni
3. Avvertenze
4. Precauzioni
5. Reazioni avverse
6. Istruzioni passo dopo passo
6.1. Contenuto della confezione
6.2. Presentazione del prodotto
6.3. Installazione / Sostituzione della batteria
6.4. Prima di iniziare
6.5. Funzionamento del dispositivo
6.6. Feedback Aud
6.7. Spegnimento automatico
7. Manutenzione, igiene e sterilizzazione
8. Individuazione di inconvenienti
9. Garanzia
10. Liberatoria
11. Certificazione
12. Rappresentante Europeo autorizzato
13. Specifiche tecniche
14. Simboli standard
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Indice
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