Instruction For Use - English - Elos Torque Wrench Instructions For Use Manual

Instruction for use - English

Elos Torque Wrench & Driver
1 Intended use
The Elos Torque Wrench & Driver is adaptable to a variety of tools in order
to apply torque for either tightening/loosening/removing a screw and or
implant during a surgical procedure.
2 Product Description
The Elos Torque Wrench (main body, head and Elos Driver) is made of
lightweight titanium and stainless steel. The Elos 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 Elos Torque Wrench & Driver is easy to prepare for
cleaning, disinfection and sterilization.
Exchangeable screwdrivers and the Elos Driver make the tool compatible to
various implant systems.
3 Use
The Elos 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 and 6. The use of the Elos Torque Wrench & Driver is described
below:
1. After cleaning make sure the first line on the scale of the Elos Torque
Wrench arm aligns with the arrow (see figure 1.A).
2. Attach the head to the body of the Elos 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 Elos Torque Wrench shows the
direction in which the Elos 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 Elos Torque Wrench to the
opposite side (see figure 3) and push the Elos Driver into the head of
the Elos Torque Wrench until an audible click is achieved (see figure
4).
4. Insert the tool into the Elos Driver.
5. Place the tool in the implant/screw and turn the Elos 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 Elos Torque Wrench & Driver
according to section 5 and 6.
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 Elos Torque Wrench & Driver does not require recalibration but before
each use, make sure that the Elos 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).
Elos Medtech Pinol A/S
Engvej 33
DK - 3330 Gørløse
www.elosmedtech.com
Electronic IFU can be accessed at http://elosmedtech.com/IFU/
Document ID: DEV-00275 version 3.0

Do not exceed max scale
The arm of the Elos Torque Wrench must not go beyond the end of the
scale (see figure 6.B), as this could result in permanent deformation of the
Elos Torque Wrench arm i.e. future inaccurate torque readings (see figure
1.B).

No scale indication when used as ratchet wrench
If the Elos 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 Elos Torque
Wrench & Driver is used as a ratchet wrench.

Use screw/screwdriver/Driver/implant manufacturer torque
recommendations
Please check the individual screw/screwdriver/Elos 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 Elos Torque Wrench & Driver is used as a ratchet wrench
(without using the Elos Torque Wrench arm).

Cleaning – do not use metal brush or steel wool
Do not use a metal brush or steel wool to clean the Elos Torque Wrench or
Driver as this will damage the instrument.

Only for use by professionals
The Elos Torque Wrench & Driver must only be used by professionals.
5 Cleaning and disinfection
The following cleaning and disinfection method is recommended:
1. The body and head of the Elos Torque Wrench are assembled by
delivery. To remove the head from the body of the Elos Torque
Wrench press into the recess area of the head/main body and gently
pull the two parts from each other.
If the Elos Driver is attached to the head of the Elos Torque Wrench
the Elos Driver must be removed before the head and body of the
Elos Torque Wrench are disassembled.
Press the Elos Driver to remove it from the head of the Elos Torque
Wrench (see figure 5).
2. The three separated parts are now ready to be cleaned with water
and brush and sterilized according to section 6.
6 Sterilization
The Elos Torque Wrench & Driver is delivered non-sterile. Steam sterilize
with a pressure of 2 atm. for 15 min. at 121°C or with a pressure of 3 atm.
for 3 min. at 134°C, according to EN ISO 17665-1:2006 is recommended.
Caution: Accompanying packaging material CANNOT be autoclaved unless
it is explicitly stated that the material is suitable for sterilization.
7 Further information
For additional information about the use of the Elos Torque Wrench &
Driver, please contact your local sales representative.
8 Validity
Upon publication of this instruction for use, all previous versions are
superseded.
9 Storage and Handling
The Elos Torque Wrench & Driver should be stored at room temperature.
Store at 10°- 40°C (50°-104°F).
10 Disposal
The Elos Torque Wrench & Driver must be disposed as biological waste.
Caution: U.S. Federal Law restricts this device to sale by or on the order of
a licensed dentist or physician.
5 / 19