Anthogyr SAFE User manual

SafE
IMPACTEUR AUTOMATIQUE
AUTOMATIC IMPACTOR
AUTOMATISCHER IMPAKTOR
IMPACTADOR AUTOMÁTICO
IMPATTATORE AUTOMATICO
IMPACTADOR AUTOMÁTICO
AUTOMATISCHE IMPACTOR
自动敲击器

FR - NOTICE D’INSTRUCTION
EN - INSTRUCTIONS FOR USE
US - INSTRUCTIONS FOR USE
DE - GEBRAUCHSANWEISUNG
ES - INSTRUCCIONES DE USO
IT - ISTRUZIONI PER L'USO
PT - INSTRUÇÕES DE USO
NL - GEBRUIKSAANWIJZING
ZH - 使用说明
AR - 

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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 (Impactor + 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 intendedfor 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 densityis 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
inhazardous 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 concerningthe 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-protectionandin the protectionof patients.
Inaccordance 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 (Impactor +
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 (Impactor + 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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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

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VI. MD START UP PROCEDURE
TheMD (Impactor+Instruments)aresupplied non-sterile and
non-lubricated*.
Before using for the first time, the MD (Impactor + Instruments)
must be cleaned, decontaminated, lubricated* and sterilised (see
the section on "Hygiene and maintenance").
*: for the “Impactor SAFE3” MD only
Resterilisation of reusable MD (Impactor + Instruments)
must be performed by properly trained and protected
personnel, in accordance with the applicable regulations. The
resterilisation protocol must be adapted for a risk of infection.
Before use, check that the MD (Impactor + Instruments)
and/or the osteotomes are not damaged and that no parts
are missing. Check the condition of the instruments used and
handle them with caution and care. (The list of accessories is
included in paragraph IX)
6.1. Motor connection:
Protective gloves should preferably be used whenever the
tools are handled.
Check the condition of the MD Impactor used and handle it with due
care and attention.
The MD (Impactor) may only be connected to the motor
outside of the patient's mouth and when the motor has been
stopped.
Position the MD (Impactor) on the motor coupling (in accordance
with EN 23964 - ISO 3964) until it clicks into place. Keep the motor
and the MD (Impactor) on the same axis for this purpose.
For certain motors, it is necessary to activate the side button to
facilitate the connection.
Pull gently on the MD (Impactor) every time before use in order to
verify that it is correctly engaged on the motor coupling.
Functional test
Run the motor in the normal direction (the device will not
operate if the motor is in "reverse" mode). Check that the
MD (Impactor) properlygeneratesregular micro-impacts.
NOTE: If you notice overheating, irregularities, vibrations or abnor-
mal sounds during operation of the MD (Impactor), immediately
contact your authorised technical service centre.
6.2. Disconnecting the motor:
CAUTION: The MD (Impactor) may only be disconnected
when the motor has been stopped, and outside of the
patient's mouth. Withdraw the MD (Impactor) while maintaining the
axis of the motor. For certain motors, it is necessary to activate the
side button to enable the MD (Impactor) to be disconnected.
NOTE: To prevent oil from leaking into the motor, do not leave the
MD (Impactor) connected to the motor if the MD (Impactor) is not
used for prolonged periods.
6.3. Connecting / disconnecting the instrument:
The instruments may only be connected to the MD Impactor
when the motor is switched off and outside the patient’s
mouth.
Protective gloves should preferably be used whenever the
tools are handled.
Check the condition of the instruments used and handle
them with caution and care.
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6.4. Locking/unlocking the MD (Instruments) in the MD
(Impactor) :
Positioning a tool:
Align the arrow on the ferrule with the open padlock
If the MD (Instruments) has a trefoil symbol, align the symbol on
the MD (Instruments) with the symbol at the end of the MD Im-
pactor connection and insert the MD (Instruments).
If the MD (Impactor) is standard, insert the tool by locating the
drive bar.
• Turn the collet to align the arrow with the closed padlock and
lock the MD(Impactor) on the MD (Impactor).
Check that the MDs (Instruments) are firmly in place by applying
gentle traction to them.

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Removing a tool:
Align the arrow on the ferrule with the open padlock
Withdraw the tool by pulling on it
After insertion of an instrument, check its correct retention
with a slight axial movement.
It is essential that the motor is stopped and outside of the patient's
mouth whenever the instrument is inserted or extracted.
The MD (Impactor + Instruments) does not require maintenance
work. Nevertheless, should you notice a functional defect in the
locking or gripping mechanism, this could mean that it is dam-
aged. In this case, immediately return the device to the Anthogyr
after-sales service department.
Make sure that the device does not have any areas of corrosion or
cracks, and check that it is working properly.
MD lifecycle
If used in a proper manner, all MD parts have a lifecycle corre-
sponding to 250 sterilisation cycles.
However, these indications are not a warranty because wear may
appear prematurely, depending on how the MD is maintained
(cleaning and sterilisation).
VII. HYGIENE AND MAINTENANCE
Sterilisation of MD (Impactor + Instruments) must be per
formed by properly trained and protected personnel, in
accordance with the applicable regulations. The sterilisation
protocol must be adapted for the risk of infection.
In order to avoid any risk of infection and injury, it is essen-
tialto wear protective gloves.
Refer to the manufacturer’s instructions for each product
used. Observe the concentrations, lengths of exposure and
the lifespan of the products. Do not combine products and ob-
serve the provisions regarding their disposal.
Only use products that are intendedfor the maintenance of
medical and surgical equipment, compatible with stainless
steel (no chlorine compounds), and compatible with aluminium
(no soda).
Avoid the use of antiseptics that are intended for use on the skin
and on mucous membranes.
Avoid the use of products containing aldehydes, alcohol or other
products that are likelyto bind proteins.
Preference should be given to detergents / disinfectants that are
pH neutral or slightly alkaline.
The device must be cleaned and sterilised after every procedure.
The motor must be disconnected or stopped before handling.
Instruments must not be connected to the MD Impactor.
The MD Impactor is not removable and is not submersible.
The instrumentsare submersible.
7.1. Manual preparation for sterilisation:
Reprocessing of the MD (Impactor + Instruments) must be carried
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out as soon as possible after treatment (within max. 2 hours).
By brushing:
Brush under running water using a soft brush.
Clean the entire MD (Impactor + Instruments) using a disinfectant
wipe.
Or by spraying:
Spray the disinfectant on to the MD (Impactor + Instruments) and
wipe using a clean cloth.
Rinsing and drying
Rinse properly1
Dry the entire MD (Impactor + Instruments).
7.2. Automatic preparation for sterilisation:
Only use a washer-disinfector appropriate for the repro-
cessing of this type of MD (Impactor + Instruments). Follow
the instructions provided by the manufacturer of the unit.
If the unit is equipped with nozzles for contra-angles: Fit the MD
Impactor onto the nozzle of the device.
If the unit is not equipped with nozzles for contra-angles: without
disassembling the MD impacor, position it with the tool connection
component pointing upwards. Position the parts so that any reten-
tion of fluid is avoided. Immobilise each part.
The thermal disinfection cycle must be at least 10 minutes at 93°
C (203°F).
Follow the instructionsfor use provided by the thermal disinfector
manufacturer, and in particular the recommendations regarding
the products that shouldorshould not be used with the unit.
Observe the drying cycle (Caution: Do not exceed 140°C (284°F)
during the drying cycle)
Check that there is no residue and that all parts of the MD
(Impactor + Instruments) are perfectly dry at the end of the cycle.
The MD impactor is not submersible.
7.3. Lubrication:
Wear a protective face mask.
Disconnect the MD (Impactor) from the motor before handling.
Remove the connected instrument in the MD (Impactor)
Check that the nozzle of the spray is the correct one for use with
the MD (Impactor).
Insert the aerosolspray at the back of the MD (Impactor).
Cover the head (connecting part) of the MD (Impactor) with a wipe.
Position the head (connecting part) of the MD (Impactor) down-
ward.
Spray several times, keeping the MD (Impactor) closed.
Wipe off surplus oil with a soft cloth or a wipe.
Lubricate after each decontamination and before each
sterilisation,and repeat in the event of prolonged use.
Keep away from heat and ignition sources. Smoking is
strictly prohibited!
7.4. Functional test:
This test must be performed every time prior to sterilisation.
Connect the MD (Impactor) to the motor and point the head
downwards. Run at low speed (5000 motor rpm) for 30 seconds in
order to clear the excess oil, then at full speed (10,000 motor rpm)
for 30 seconds. Wipe the MD (Impactor) with a disinfectant wipe if
the oil has dripped.
Note: If you notice overheating, irregularities, vibrations or abnor-
mal sounds during operation of the MD (Impactor) , immediately
contact your authorised technical service centre.
7.5. Sterilisation:
Resterilisation of reusable MDs must be performed by
properly trained and protected personnel, in accordance
with the applicable regulations. The resterilisation protocol must
be adapted for a risk of infection.
The MD (Impactor + Instruments) and the accessories must
be sterilised before they are used for the first time, and
every time after they are used (after cleaning and disinfection).
Do not sterilise instruments unless theyhave been pre-disinfected,
cleaned, decontaminated, lubricated (only the MD Impactor) and
tested.
No disassembly of the MD is envisaged prior to performing
sterilisation.
1 : Temperature <38°C, demineralised water is recommended instead of running water, for example
ifthelatter contains too much chlorine (see the FD98-135 standard)
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We stronglyadvise the use of a class B autoclave.
All other methods of sterilisation must be avoided.
Read the instructions for use provided by the autoclave manufac-
turer.
Maintain the space between the bags and do not overload the
autoclave.
Only sterilise instruments that have been predisinfected, cleaned,
lubricated and tested.
Remove the instruments from the MD Impactor before sterilisa-
tion (See Section 5.5).
Make sure that the MD (Impactor + Instruments) do not have any
areas of corrosion or cracks, and checkthat it is working properly.
Ensure that the MD (Impactor + Instruments) are dry; if necessary,
dry any residual waterusing medical quality pressurised air.
Use the sterilisation bags that are designed for the MD (Impactor+
Instruments) and for the autoclave, or use a sterilisation cassette.
Each bag should always only contain one MD or sterilisation tray.
In order to avoid any retention of water, place the bag in the
autoclave in such a way that any hollow parts are face
down.
If the pre-vacuum autoclave offers a number of different cycles,
choose a cycle for MD (at least 135°C at 2.13 bar (275°F at 30.88
psi) for 3 minutes with a drying timeof 16 minutes).
After every sterilisation cycle, check that there is no water re-
maining on the inside and outside of the packaging.
Check that the change in colour of the flow indicator is correct.
7.6. Storage:
Keep the MD (Impactor + Instruments) in the sterilisation
bags away from light, moisture and contamination of any
kind. Follow the recommendations of the packaging manufacturer.
The duration for which the MD (Impactor + Instruments) may be
kept after sterilisation may not exceed 1 month.
Label the MD (Impactor + Instruments), specifying the expiration
date. After the expiration date, repeat the cleaning and sterilisa-
tion cycle.
VIII. REPAIRS
In the case of device failure, please contact your authorised
distributor, or contact our after-sales service department directly.
Repairs may only be carriedout by an authorised repair service or
by the Anthogyr after-sales service department, and only using
original Anthogyr replacement parts.
For any servicing or repair work, the MD must be returned com-
plete and sterile with proof of sterility. It must be accompanied by
a document that describes the problem in question and also
includes the complete contact details of the practitioner who used
the device.
Exchange of replacement parts is possible for 7 years after sales
discontinuation.
CONTACT DETAILS: AFTER-SALES SERVICE
AFTER-SALES SERVICE DEPARTMENT
Anthogyr
2237 Avenue André Lasquin -74700 Sallanches - FRANCE
Direct line: [phone]
Mail: [e-mail]
IX. GUARANTEE
These MD (Impactor + Instruments) are guaranteed for parts and
labour against any defect in manufacture for a period of 12
months from the date of invoicing. This guarantee does not apply
to wear parts and does not cover transport costs. For claims to be
considered under the guarantee, please enclose a copy of the
invoice or the delivery note with the MD (Impactor + Instruments) .
Any modification of or addition to the product without the express
consent of Anthogyr will nullify this guarantee.
The guarantee shall become null and void if the technical instruc-
tions supplied with all of our equipment are not observed.
Anthogyr cannot be held responsible for damage and ensuing
damage resulting or possibly resulting from normal wear and
tear, incorrect use, cleaning or maintenance, non-compliance
with the provisions regarding use or connection, scaling or corro-
sion, impurities in the water supply system or abnormal chemical
or electrical effects, or non-compliance with the instructions for
use, maintenance or installation provided by Anthogyr, and other
manufacturer instructions.
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X. ACCESSORIES - INSTRUMENTS
Instruments
Accessories
XI. CONDITIONS OF STORAGE & TRANSPORT
XII. DISPOSAL OF THE PRODUCT
The MD (Impactor + Instruments) must be sterilised before dispos-
al in order to prevent the risk of third-party contamination.
On the basis of current knowledge, the product does not contain
any substances that are harmful to the environment. Observe
national legislation, standards and provisions with regard to
disposal.
References Designation
OSTSCC34 OsteotomeØ3.4 concavestraight
OSTEOSAFE Solution
OSTSCC40 OsteotomeØ4.0 concavestraight
OSTSCC46 OsteotomeØ4.6 concavestraight
OSTSCC52 OsteotomeØ5.2 concavestraight
OSTSCX34 OsteotomeØ5.2 convex straight
OSTSCX40 OsteotomeØ4.6 convex straight
OSTSCX46 OsteotomeØ4.0 convex straight
OSTSCX52 OsteotomeØ3.4 convex straight
OSTECC34 Osteotome Ø3.4 concave bayonet
OSTECC40 Osteotome Ø4.0 concave bayonet
OSTECC46 Osteotome Ø4.6 concave bayonet
OSTECC52 Osteotome Ø5.2 concave bayonet
OSTECX34 Osteotome Ø3.4 convex bayonet
OSTECX40 Osteotome Ø4.0 convex bayonet
OSTECX46 Osteotome Ø4.6 convex bayonet
OSTECX52 Osteotome Ø5.2 convex bayonet
OPIP100 Tip for abutment 0°/7°
SAFELOCK®
Solution
OPIP200 Tip for abutment 15°/23°
OPIP400 Tip for extra-orally cemented prosthesis
PERIO01 Cx right Fine Periotome
EXO SAFE Solution
PERIO02 Cx rightWide Periotome
PERIO03 Cx Ang. Vertical Periotome
PERIO04 Cx Ang. Horizontal Periotome
PERIO05 Cc right Fine Periotome
PERIO06 Cc right Medium Periotome
References Designation
1930X Lubricating spray All
solutions
1932X ISO type E connection tip

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REF 1636920SAFE_NOT-2016-03 Made in France
2237 avenue André Lasquin
74700 SALLANCHES - FRANCE
Tél. [phone]
Fax [phone]
N°SAV / Repairs :
[phone]
E-mail : [email protected]
www.anthogyr.com