Medartis MODUS 90° Instructions For Use

Instructions for Use for
MODUS 90° Screwdriver
Introduction
These instructions for use are for a product line of
Medartis AG, Hochbergerstrasse 60E, 4057 Basel/Switzerland
Phone +41 61 633 34 34, Fax +41 61 633 34 00, www.medartis.com.
All instructions provided in this document must be followed.
Description of the MODUS 90° Screwdriver
The MODUS 90° Screwdriver consists of the following parts:
1 = Screwdriver (M-2410) 2 = Sliding button (M-2414); 3 = Slider; 4 = Neck;
5 = Push rod; 6 = Rotation knob (M-2430); 7 = Torque-limiting knob (M-2438)
8 = Screwholding fork (M-2412)
The MODUS 90° Screwdriver is designed for intraoral drilling and screw insertion as described
in the section entitled "Intended Use".
The MODUS 90° Screwdriver is comprised of interchangeable twist drills and screwdriver
blades with a dental shaft end as well as a screwholding fork that holds the screw securely
during insertion. Optionally, self-holding blades can also be used without the screwholding fork.
MODUS 90° Screwdriver (M-2410) with screw secured with screw holding fork:
MODUS 90° Screwdriver with screw on self-holding blade:
Notes Regarding the Delivered Goods
The individual parts of the system may only be accepted when the manufacturer's label and
packaging are undamaged and unopened at the time of delivery. If this is not the case, the
rejected goods must be returned to Medartis AG, Basel/Switzerland or to the relevant Medartis
branch or distribution partner within ten working days.
All components are delivered NON-STERILE and must be appropriately prepared before first
use.
All packaging must be removed before preparation.
Product Materials
The 90° Screwdriver is made from stainless steel and aluminum. The neck is made from brass
(plated with nickel and chrome).
Intended Use
The MODUS 90° Screwdriver was developed for pre-drilling and for the insertion of implant
screws via intraoral access. It is designed for use with MODUS screws together with 1.5/2.0
cross-drive screwdriver blades, HexaDrive 4 (HD4) and HexaDrive 6 (HD6) (including TriLock
screws). Failure to use the screwdriver as intended may damage the hand piece and result in
risks and hazards for users and/or the patient.
Indications
The MODUS 90° Screwdriver can be used for intraoral access for the following purposes:
• Osteosyntheses in area of the mandibular angle
• Sagittal split osteotomies
• Distractions
• Screw and plate removal
Contraindications
There are no known product-specific contraindications.
MANDIBLE-00000801_RevB
Instructions for Use for MODUS 90° Screwdriver
Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks and brands of Medartis AG, 4057 Basel/Switzerland
Potential complications with the MODUS
90° Screwdriver
•
If the screwholding fork is not retracted after a few turns during the screw insertion process,
the MODUS 90° Screwdriver may become wedged together with the plate. In this case,
releasing the screwholding fork will be extremely difficult
•
Incorrect cleaning and/or care may possibly result in the drive seizing
•
When loosening the sliding button for the cleaning process, lifting the button with too much
force (bending the spring too far) may result in damage to the sliding button and a loss of
functionality
Warnings and Precautionary Measures
• The products may only be used by medical personnel who hold relevant qualifications
• Medartis, as a private label manufacturer, recommends that the user carefully reads all
available documents before first use and contacts other users who have practical experience
with this type of treatment
• Never use products that have been damaged by transport, improper handling in the hospital,
or in any other way!
• All components of the screwdriver have been developed and manufactured for a specific
purpose and are therefore precisely adapted to each other. The user may not alter any of
the components or replace them with a product from another manufacturer even if the size
or shape is similar or exactly corresponds to that of the original product. Utilized materials
from other manufacturers, structural changes resulting from the use of third-party products
and/or material impurities as well as minor deviations or imprecise fit can represent a risk for
the user, the patient or to third parties
• Unless otherwise expressly stated on the label, the screwdriver can be reused
• Medartis recommends that the maximum initial speed in the handset for pre-drilling should
not exceed 1'700 revolutions per minute . This corresponds to an initial speed at the drill of
approximately 1'000 revolutions per minute (translation ratio: 1.66:1)
• The maximum permissible torque for the drive in the screwdriver is 100 Ncm to avoid a risk
of damage
• The screwdriver may only be operated on drive units that are compliant with the guidelines
for medical devices
• Always ensure that the operating conditions are correct
• Before each use, inspect the screwdriver for damage and loose parts (e.g. the sliding button,
screwholding fork)
Instruction for Selecting the Appropriate Product
This medical device is intended solely for use by medical professionals. The operating surgeon
is responsible for the correct patient selection and proper use of the MODUS 90° Screwdriver.
Medartis, as a private label manufacturer, does not recommend a specific surgical procedure for
a specific patient.
The treating physician should beforehand become thoroughly familiarized with the procedure,
for example by:
•
Carefully studying all the product documentation
•
Carefully reviewing the current professional literature
Additional Information
Additional information on the product can be requested from your local Medartis branch or your
distribution partner. In addition, all relevant information can be found on the internet at
.www.medartis.com.
Commencing Operation
Medartis recommends working with two MODUS 90° Screwdrivers (one set up for drilling and
one for screw insertion).
Installation and Removal
• When using with the power drive, do not install or remove during operation!
• Fit the screwdriver with the power drive or rotation knob (1)
• Check that it is seated firmly on the power drive or rotation knob (2)
• Remove the screwdriver by pulling it off or, if applicable for your power drive, by pressing the
release button (3)
Instructions for the Use of Drills
• Only use Medartis twist drills with dental shaft end
•
Only use twist drills that are completely free of defects
When drilling with a power drive, only attach the drill when the screwdriver is not in
operation
Never touch drills while running or in the process of stopping
Never operate the sliding button while the screwdriver is in use. This will result in the
drill being released
•
Fitting the twist drill
Open sliding button
Insert twist drill until it stops (slightly rotating the drill if necessary)
Close sliding button
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