Anthogyr Xpert Unit User manual

fr - Manuel d’utilisation
en - User manual
de - Gebrauchsanweisung
es - Manual de uso
it - Manuale d'uso
pt - Manual de utilização
nl - Gebruikershandleiding
zh - 使用说明
- ar
hu - Felhasználói útmutató
pl -
ro - Manual de utilizare
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TABLE OF CONTENTS
Implantology motor
1. DESCRIPTION OF SYMBOLS 22
2. INTRODUCTION 23
3. AREA OF USE 23
4. INDICATIONS AND CONTRAINDICATIONS 23
5. SAFETY 24
6. DESCRIPTION 27
7. CONNECTIONS - INSTALLATION 28
8. INITIALISING THE CONSOLE 30
9. USE 31
10. PARAMETER MANAGEMENT 35
11. CLEANING, DISINFECTING AND STERILISATION 35
12. CONDITIONS OF USE AND STORAGE 36
13. WARRANTY 36
14. MANUFACTURER'S RESPONSIBILITIES 37
15. REGULATIONS 37
16. ANOMALIES AND FAULTS 37
17. TROUBLESHOOTING OPERATIONS BY THE USER 39
18. TECHNICAL SAFETY INSPECTION BY AGENCY 39
19. ELECTROMAGNETIC COMPATIBILITY 39
20. REFERENCE 41
1. DESCRIPTION OF SYMBOLS
n Alternating current h Fragile iTransport in standing position; with the top
facing the direction of the arrow
C Type B equipment. Z Store in a dry place Q Sterile device
E Warning : Follow the operating
instructions J Maximum permitted stack load 50 kg W Do not reuse, single-use device
m Protective earth k Handle with care xDo not place in domestic dustbin
A Manufacturer V Device expiry date tDo not tilt
M Class IIa device in compliance
with European directive
93/42CEE O Device manufacturing lot
number IP4x Protection against foreign bodies > 1 mm
f Thermodisinfectable device P Serial number IPx6 Protection against strong water spurts in all
directions
g Sterilisable at a specific tem-
perature DHumidity limit D Follow the operating instructions.
X Do not use if the packaging is
damaged EAtmospheric pressure limit ù Do not sterilise
Y Protect from light N Commercial reference num-
ber of the device Refer the instruction manual/brochure
k Permissible temperature
limits Risk of crushing - Do not touch rotating parts with your finger when the pump is on
MD Medical Device

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2. INTRODUCTION
You have just acquired your new dental implantology motor, XPERT UNIT®.
Anthogyr congratulates you for your choice and thanks you for your confidence in this product.
In order to complete and sustainable benefit from this product, it is recommended that you read this user manual first and perform the
recommended inspection and maintenance tasks.
This Anthogyr product is to be used exclusively with the accessories provided by Anthogyr (micromotor, pedal, power supply cable). The
use of any other accessories is prohibited.
This equipment is compatible with most of the surgical contra-angles and handpieces available on the market. However, the technical
features (torque and speed) of this product can only be used with the Anthogyr Mont Blanc®contra-angle.
It is mandatory to use the irrigation lines supplied by Anthogyr. The use of any other irrigation lines can create malfunctioning for which
Anthogyr cannot be held responsible in any way.
It is essential to take all the precautions mentioned with the symbols Ein order to keep the equipment in optimal condition with total safety.
The manufacturer reserves the right to make changes or improvements in the equipment as a result of from new technical developments.
This does not give retrospective rights to equipment already installed.
To ensure that the Anthogyr product is operational at all times and to maintain it in good working condition, adhere to the maintenance,
disinfection, and sterilisation instructions (see section “11 - Cleaning, disinfecting, and sterilisation”).
Only Anthogyr technicians or those trained by Anthogyr are authorised to repair the medical device (Check your equipment control
parameters after maintenance operations; it is possible that it has been set to default values).
These instructions may not by copied and distributed without the prior written consent the Anthogyr .
The user is under obligation to :
→Use only products that are free of defects.
→Protect patients, third parties, and oneself from any danger.
→Avoid any contamination to spread through the product.
The user is responsible for checking the operating safety and the condition of the equipment before each use.
While using the product, it is essential to adhere to the national legal provisions and particularly :
→Provisions applicable to connecting and starting the MD.
→Provisions applicable to safety at work.
→Provisions for prevention of accidents.
3. AREA OF USE
3.1. PATIENT POPULATION AND CONDITION TO BE TREATED
Patients in need for dental, maxillofacial or implant surgery.
3.2. INTENDED USER
Dental surgeon or Oral and maxillofacial surgeon.
3.3. INTENDED USE
XPERT UNIT®motors are intended to drive dental handpieces equipped with instruments to cut hard and soft tissues in the mouth and to
insert dental implants, with a control of the tool speed and irrigation supply.
The device also provides an indication of the torque applied at implant placement when used in combination with Anthogyr Mont Blanc®
contra-angle handpieces.
An interface (screen or pedal) allows the user to adjust and memorize different settings for the parameters of speed, torque, pump flow,
and reduction gear.
4. INDICATIONS AND CONTRAINDICATIONS
4.1. INDICATIONS
XPERT UNIT®motors are indicated to perform surgeries in patients requiring a dental surgery or dental implant placement.
4.2. CONTRAINDICATIONS
Patient presenting contra-indications to an oral surgical procedure.

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5. SAFETY
5.1. RESIDUAL RISKS AND SIDE EFFECTS
Surgical motors misuse (error in the selection or tuning of predefined surgical sequence, rotation speed or direction, pre-selection of
operating limits) may lead to patient injury.
5.2. WARNING SIGN
In order to avoid any physical or material damage, this document divides the safety instructions into three levels of danger.
5.3. SAFETY INSTRUCTIONS
5.3.1 - External interference
The equipment is certified to comply with the electromagnetic compatibility standards currently in force.
5.3.2 - Electrical connection
However, the user must ensure that no further risk is created by electromagnetic disturbance.
To avoid disturbing the proper functioning of the electromagnetic equipment, it is recommended to adhere to the stipulated distances
among devices (“see section 19. ”Electromagnetic compatibility”).
ATTENTION
This equipment is not designed to withstand shocks from an electric defibrillator.
WARNING
ELECTRIC SHOCK / ELECTROCUTION
Non-compliant electrical connection
Compulsorily check that the power supply voltage is identical to that whitch is indicate on the control box.
Check the power supply cable before every use.
Never insert or pull the plug from the wall socket with wet hands.
DANGER
To avoid any risk of an electric shock, this equipment must only be connected to a power supply network equipped with protective
earthing.
WARNING
E
Warning sign
Indicates a hazardous situation that may cause material damage or from minor to moderate injuries.
ATTENTION
Indicates a hazardous situation that may cause serious/fatal injuries.
WARNING
Indicates maximum danger created by a situation that may immediately cause serious/fatal injuries.
DANGER

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5.3.3 - Environment
5.3.4 - Use of the device
5.3.5 - Storage conditions
5.3.6 - Peristaltic pump
5.3.7 - Micromotor and micrometer cable
Recommended conditions : protect from moisture and store at room temperature.
Keep away from sunlight, sparks and other sources of ignition.
Temperature : from -20 °C to +70 °C.
Air humidity level : from 5% to 95%.
Incompatible materials : acids and other solvents.
ATTENTION
Do not operate the pump if the irrigation line is blocked or closed by a clamp.
Always place the fluid to be pumped above the pump, in order to ensure optimal operation of the latter.
Always keep the pump head rollers and all moving parts clean and free of contamination and debris.
ATTENTION
Do not open the guard when the pump is rotating.
Do not touch the rotating parts with your fingers when the pump is in operation.
ATTENTION
Refer to the instructions for use supplied with the micromotor and/or micromotor cable to familiarise yourself with all safety and usage
aspects.
ATTENTION
Never attempt any repair alone.
DANGER
Do not tilt the device.
Ensure that the cords do not obstruct the free movement of persons.
Do not use the device near ionising radiation.
The device must be connected to a nearby wall socket that is easily accessible. The required power cords include a plug that can bear at
least 125% of the rated current of the device.
Use a maximum impedance network of 4Ω.
ATTENTION
Do not use this product in premises with explosion hazards.
Do not expose the equipment to water splashes or water mist.
In order to avoid risk of electric shock, short-circuit, or emission of dangerous substances, do not insert metalic objects into the equip-
ment.
DANGER
ELECTROCUTION
Accidental penetration of liquid in the fuse box.
Before every use, check and ensure impermeability of containers of liquids. If any liquid should penetrate the equipment, do not touch it
and immediately disconnect the power supply cable from the electricity network. Make sure that the surface of the equipment is
completely dry before reconnecting the power supply cable.
DANGER
Do not move the device while in use.
We strongly recommend that the torque be limited so as not to exceed the manufacturers’ recommendations for the instrumentation
used. This is to limit the risk of injury and deterioration of instruments.
ATTENTION
Once the servicing work is completed, switch off the device. Unplug it from the electrical mains in the event of prolonged non-use.
WARNING