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Idiomas disponibles
Instruction for use - English
Torque Wrench & Driver (35, 45, 70 & 100Ncm)
1
Intended use
A dental torque wrench for placement and adjustment of dental implants,
abutments, abutment screw and prosthetic screws during oral surgery and
prosthetic procedures. By use of exchangeable screwdriver tips and bits the
tool can be used for Astra Tech Implant System.
2
Product Description
The Torque Wrench (main body, head and Driver) is made of lightweight
titanium and stainless steel. The Torque Wrench & Driver product design,
finish and quality make the tool well suited for placement and adjustment of
implants, abutments and screws during surgery and other clinical
procedures. The Torque Wrench & Driver is easy to prepare for cleaning,
disinfection and sterilization.
Exchangeable screwdrivers and the Driver make the tool compatible to
various implant systems. The driver is available for a variety of connections.
For specific product descriptions, please refer to individual product labels.
3
Use
The Torque Wrench & Driver is delivered non-sterile. Prior to use it must be
cleaned with water and brush followed by sterilization according to section 5.
The use of the Torque Wrench & Driver is described below:
1.
After cleaning make sure the first line on the scale of the Torque
Wrench arm aligns with the arrow (see figure 1.A).
2.
Attach the head to the body of the Torque Wrench by pushing the
components together and turning them in opposite direction until an
audible click is achieved (see figure 2).
3.
The arrow on the head of the Torque Wrench shows the direction in
which the Torque Wrench & Driver is functioning, and the head is
labeled "IN" (see figure 3.A) and "OUT" (see figure 3.B). "IN" denotes
clockwise rotation; "OUT" denotes counterclockwise rotation. In order
to change direction, flip the Torque Wrench to the opposite side (see
figure 3) and push the Driver into the head of the Torque Wrench until
an audible click is achieved (see figure 4).
4.
Insert the tool into the Driver.
5.
Place the tool in the implant/screw and turn the Torque Wrench arm
in the direction of the arrow until the desired torque is archived (see
figure 6). The applied torque must be in accordance with the
screw/implant manufacturers' instructions.
6.
After each use clean and sterilize the Torque Wrench & Driver
according to section 5.
7.
Inspect instruments under normal lighting for the removal of visible
soil and for damage or wear: Any instrument showing visible damage
or wear must be disposed of according to section 9
4
Warnings and precautions
Potential adverse occurrences may include but are not limited to the
following list. Proper placement and use of this instrument may help to
mitigate these risks.
•
If overloaded or dropped
If overloaded, dropped or in other way mishandled, the product must no
longer be used since correct functionality can no longer be guaranteed.
•
Do not use hydrogen peroxide
This product must be sterilized prior to use and it must not be cleaned by
using hydrogen peroxide.
•
Scale alignment
The Torque Wrench & Driver does not require recalibration but before each
use, make sure that the Torque Wrench & Driver is fully functional and that
the first line on the scale aligns with the arrow (see figure 1.A).
•
Ensure correct assembly
Before each use, make sure that all parts are correct assembled (no loose
parts are allowed).
•
Do not exceed max scale
The arm of the Torque Wrench must not go beyond the end of the scale
(see figure 6.B), as this could result in permanent deformation of the Torque
Wrench arm i.e. future inaccurate torque readings (see figure 1.B).
•
No scale indication when used as ratchet wrench
Elos Medtech Pinol A/S
Engvej 33
DK - 3330 Gørløse
www.elosmedtech.com
Document ID: DEV-01072 version 3.0
If the Torque Wrench & Driver is used as a ratchet wrench it does NOT
provide the user any indication of what torque that is used.
Notice: the torque applied must not exceed 150Ncm when the Torque
Wrench & Driver is used as a ratchet wrench.
•
Please check the individual screw/screwdriver/ Driver/implant
manufacturers' instruction for use or label regarding the maximum allowed
torque. Do not under any circumstances apply higher torque than stated
even if the Torque Wrench & Driver is used as a ratchet wrench (without
using the Torque Wrench arm).
•
Do not use a metal brush or steel wool to clean the Torque Wrench or Driver
as this will damage the instrument.
•
The Torque Wrench & Driver must only be used by professionals.
5
The following cleaning and disinfection method are recommended.
Further instruction can be found in "Cleaning and sterilization guideline" at
https://elosmedtech.com/IFU/
1.
2.
3.
Note: For US: Steam Sterilization Cycle 132°C (270°F)/4min.
Procedure
Exposure time
Temperature
Drying time
Caution: Accompanying packaging material CANNOT be autoclaved unless
it is explicitly stated that the material is suitable for sterilization.
6
For additional information about the use of the Torque Wrench & Driver,
please contact your local sales representative.
7
Upon publication of this instruction for use, all previous versions are
.
superseded.
8
Recommended storage temperature range is 10-40˚C (50-104˚F) and the
recommended relative humidity range is 0-80%
9
When disposed of The Torque Wrench & Driver may present an infection or
microbial hazard and should therefore be disposed of as biological waste,
according to national requirements.
10
If any serious incidents occur in relation with this device, they should be
reported to Elos Medtech Pinol A/S and to the competent authorities in the
country where the incident occurred. A serious incident is a situation where
the device directly or indirectly led or might have led to death, a serious
deterioration in the health of a person or a serious public health threat.
Contact Elos Medtech Pinol A/S at:
Caution: U.S. Federal Law restricts this device to sale by or on the order of
a licensed dentist or physician.
Use screw/screwdriver/Driver/implant manufacturer torque
recommendations
Cleaning – do not use metal brush or steel wool
Only for use by professionals
Cleaning and sterilization
Disassemble the Torque Wrench (see figure 5)
The separated parts are now ready to be cleaned according to the
"Cleaning and sterilization guideline".
Sterilization according to the "Cleaning and sterilization guideline".
Summary below:
Dynamic-air-removal sterilization Cycle
4 min.
132°C(270°F)
Further information
Validity
Storage and Handling
Disposal
Serious Incidents:
3 min.
134° C(273°F)
20 min.
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