18
TABLE OF CONTENTS
I. DESCRIPTION OF SYMBOLS USED
II. INDICATIONS FOR USE
III. AREA OF APPLICATION
IV. GENERAL SAFETY INFORMATION
V. TECHNICAL SPECIFICATIONS
VI. MD START UP PROCEDURE
VII. HYGIENE AND MAINTENANCE
VIII. REPAIRS
IX. GUARANTEE
X. ACCESSORIES - INSTRUMENTS
XI. CONDITIONS OF STORAGE & TRANSPORT
XII. DISPOSAL OF THE PRODUCT
I. DESCRIPTION OF SYMBOLS USED
II. INDICATIONS FOR USE
The MD (Im Instruments) is intended for dental surgery.
The MD Impactor is designed to generate shocks with a controlled
intensity and duration. The number of micro-impacts is regulated
by the motor speed.
It is intended for use in the following areas:
Osteotomy:
Combined with the “osteotome” instruments, this MD impactor will
facilitate the performance of the “tapping” type osteotome tech-
nique without the need for a mallet. It will enable sinus lift proce-
dures to be performed using the crestal approach and osseous
condensations in the jaw where bone mineral density is low.
Tooth extraction:
Combined with the “periotome” instruments, this MD impactor will
initiate tooth mobility by enlarging the desmodontal space in the
interproximal, lingual and distal areas with the ultimate aim of
atraumatic extraction. The use of periotomes helps preserve the
alveolar bone.
The prosthesis:
Combined with the “end-piece impaction” instruments, this MD
impactor will facilitate the placement of prosthetic components by
means of impaction for the Axiom 2.8 range.
III. AREA OF APPLICATION
This MD (impactor + instruments) is intended exclusively for
professional use in the field of dental surgery.
Inappropriate or incorrect use could damage this device and result
in hazardous risks to the user and to third parties.
In accordance with these provisions, the MD (impactor +
instruments) may only be used by a user with experience in
dental medicine, for the described application, and in line with
applicable provisions concerning the prevention of accidents at work,
and protection at work, as well as the indications in these operating
instructions. Preparation and maintenance of this MD (impactor) may
only be carried out by persons who have been trained in the field of
infection control, in self-protection and in the protection of patients.
In accordance with these provisions, the user must:
Use working instruments solely without defects,
Observe the correct intended use
Protect themselves, as well as the patient or third parties,
against any dangers
Prevent any contamination by the product
The following situations:
Inappropriate use,
Lack of maintenance,
Use of accessories, instruments and spare parts that have not
DANGER
Please wear gloves
Visual examination
Please read this!
Batch number of the device
Device reference
Sterilisable up to 135°C
Heat disinfectable
Manufacturing date
Manufacturer
Medical Device (Im
Instruments)
Non-sterile device
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been authorised by Anthogyr.
Use of accessories and instruments from this MD with other
devices.
Modifications or additions not validated by Anthogyr to MD
relieve Anthogyr of any obligation with regard to the guarantee or
other claims.
This MD comply with Community Directive 93/42/EEC, amended by
Directive 2007/47/EEC.
IV. GENERAL SAFETY INFORMATION
Before use, ensure that the MD (Im Instruments) is
not damaged and that there are no parts missing. Check
the condition of the instruments used and handle them with due
care and attention.
The practitioner should test the MD Impactor without the patient to
ensure that it is working properly.
Protective gloves should preferably be used whenever the
tools are handled. Wear suitable protective clothing, partic-
ularly gloves, a mask and goggles.
After insertion of an instrument, check its correct retention
with a slight axial movement.
Resterilisation of reusable MD must be performed by
properly trained and protected personnel, in accordance
with the applicable regulations.
In the case of visible malfunctions or damage, stop using the
instrument immediately and inform your authorised distributor or
the manufacturer.
In the case of any questions regarding the device, contact either
your authorised distributor or the manufacturer.
All repairs must be carried out using parts and subassemblies
certified by the manufacturer.
The use of a rubber dam in order to prevent tools falling into
the mouth is strongly recommended.
Only use MDs (Instruments) that are compatible with the
MD (Impactor).
Do not use instruments from this device on any other type or brand
of MD or with any other device.
V. TECHNICAL SPECIFICATIONS
1 — Tool connection
3 — Sleeve
2 — Ferrule
4 — Motor connection
Relationship between the input rotational speed (motor) and the
output impact frequency
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2
3
4
1
REFERENCE
6920OST/6920
Total length (mm)
142
Sleeve length (mm)
124
Maximum sleeve diameter (mm)
20
Rod diameter (mm)
7
Weight (g)
195
Connection tool
Standardised mandrel (ISO 1797-1)
Mandrel with tri-lobe (proprietary
Anthogyr connection)
Locking through rotation of the ring
Connection motor
ISO 3964
Maximum torque transfer with the
MD
Using the "tri-lobe" tools: 200 N.cm
Using the ISO-standard tools: 80 N.cm
Energy
Mechanics (impacts)
Ratio 1:1
Safe Impactor
rpm
Impacts per minute
2 000
20
5 000
50
10 000
100
15 000
150
MAX