Medartis MODUS 90° User manual

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
Page 1 of 4
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 [phone], Fax [phone], 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.
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

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
Page 2 of 4
•Attaching to a power drive
{For the purpose of drilling, the MODUS 90° Screwdriver can be fitted to a power drive
with a standard ISO 3964 connection
{Remove the rotation knob and connect the drive coupling to the MODUS 90°
Screwdriver
•Trial
Start the screwdriver (maximum initial speed: 1’700 revolutions per minute). If the
screwdriver is not functioning properly (e.g. vibration, unusual noises, heating up or similar),
contact your relevant Medartis branch or distribution partner
•Drilling
Drill to the desired depth (recommended initial drill speed: < 1’000 revolutions per minute)
Instructions on the Use of Screwdriver Blades
•Only use Medartis screwdriver blades with dental shaft end
•Only use screwdriver blades that are completely free of defects
•The screwdriver is designed for manual insertion of implant screws using the appropriate
screwdriver blades. Using a power drive for the insertion of implant screws may cause
undesirable side effects or have a negative impact on the outcome of the surgery
•Inserting the screwdriver blade:
{Open sliding button
{Insert screwdriver blade until it stops (slightly rotating the blade if necessary)
{Close sliding button
Instructions for Changing Twist Drills/Screwdriver Blades
•Slide the sliding button axially forward until it stops and then insert the instrument
(screwdriver blade or twist drill) into the head until it stops (a). Twist the instrument to ensure
that it is fully inserted (X)
•Pull the sliding button all the way back in an axial direction until it catches (Y)
•Pull to check that the instrument is securely seated (Z)
•To remove the instrument, pull the sliding button forwards again and pull the instrument out
([)
Instructions for Use of the Screwholding Fork
•Fitting the screwholding fork:
{The screwholding fork must be fitted if a non-self holding screwdriver blade is used
{Fit screwholding fork from below perpendicular to the longitudinal axis of the
instrument onto the neck. In doing this, ensure that the front attachment of the push
rod comes to rest beneath the screwholding fork
The small ring must engage with the notch on the inside of the screwholding fork
{Couple the rotation knob and insert the screwdriver blade
{Advance the blade toward the head of the implant screw; place the blade on the
screw and push the slider forward until the screw holding fork is holding the implant
screw
{Withdraw the slider after the first few turns of the screw in order to release the screw,
then insert the screw completely
{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
•Removing the Screwholding Fork
To remove, pull the screwholding fork downwards in a direction perpendicular to the
longitudinal axis of the instrument
Instructions for Picking Up Screws
Only MODUS screws together with 1.5/2.0 cross-drive screwdriver blades, HexaDrive 4 (HD4)
and HexaDrive 6 (HD6) (including TriLock screws) can be used.
Non Self-Holding Blades
•Fit screwdriver blade at a 90° angle to the head of the screw and slide the
screwholding fork over the sliding collar until it stops
•If available, use the loading module in the container
•Screw is secured with screwholding fork
Self-Holding Blades
•Fit screwdriver blade at a 90° angle to the screw head and pick up the screw by briefly
applying gentle pressure
•The screw is securely held in the blade
Instructions for Us of the MODUS 90° Screwdriver for Screw Insertion/Extraction
The screwdriver has two available rotation knobs, one without and one with a torque-limiting
knob. Both are screwed on/removed from the screwdriver in the same manner.
To protect the drive, Medartis recommends the use of the rotation knob with the torque-limiting
knob.
•Push rotation knob until it clicks into place
•Screw insertion: Rotate to the right (clockwise)
•Screw extraction: Rotate to the left (counterclockwise)

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
Page 3 of 4
As soon as the screw is fixed in the bone with its first screw threads, the screwholding
fork must be retracted over the sliding collar. Only then can the screw be fully inserted
without obstruction
Instructions Regarding Cleaning, Disinfection and Sterilization
All instruments in the MODUS systems are delivered NON-STERILE and must be cleaned,
disinfected and sterilized before each use. This also holds true for the first use after the delivery
(cleaning and disinfection after removing the protective transport packaging, lubrication and
sterilization). Thorough cleaning and disinfection are essential for effective sterilization.
As part of your responsibility for ensuring instrument sterility, please always ensure during use
that only adequate and suitable product-specific procedures are used for cleaning and
disinfection and that only sterilization procedures that have undergone adequate equipment and
product-specific validation are employed. Also ensure that the equipment used (sterilizer) is
regularly serviced and inspected, and that the validated parameters are met during each cycle.
The statutory regulations applicable in your country and the hospital's hygiene requirements
must also be observed. This applies in particular to the various instructions for effectively
deactivating prions.
•The screwdriver may only be prepared manually
•Remove the rotating instrument
•Remove the screwdriver from the power drive
•Clean the screwdriver and accessories immediately after treatment (within 2 hours) in
order to rinse out any penetrating fluids (such as blood, saliva, etc.) and to prevent the
internal parts from seizing
•Sterilize the screwdriver after manual cleaning and disinfection, as well as lubrication
Preliminary Disinfection
In case of stronger contamination, pre-clean with disinfection wipes (see "Disinfection" for
instructions regarding disinfectants).
Manual Cleaning
•Dismantle the instrument as far as possible (screwdriver, rotation knob and screwholding
fork)
•Rinse off and brush off the screwdriver, screw holding fork and rotation knob using
demineralized water (< 38 °C)
•Push the sliding button forwards, gently lift the sliding button from the neck and pull the
sliding button forwards and away from the screwdriver head
•If necessary, clean the exposed head area once more using a nylon brush
•Clean the sliding button for 5 minutes in an ultrasound bath (see below for general
information regarding ultrasound)
Never clean the whole screwdriver using ultrasound!
Warning:
lifting the sliding button with too much
force (bending the spring too far) may
result in damage and a loss of
functionality
Ultrasound Cleaning and Disinfection
Ultrasound is particularly suited for the cleaning of instruments made from stainless steel and
hard plastics. Mechanically sensitive instruments can be cleaned and disinfected gently and
thoroughly with the aid of ultrasound.
Ultrasound cleaning is used
•as mechanical support for manual cleaning processes
•to remove stubborn spots or after machine cleaning
•as a supportive cleaning measure for mechanical preparatory procedures
When performing ultrasound cleaning, please note the following:
•the ultrasound bath must be prepared according to the manufacturer's instructions and
refreshed each day; depending on the usage conditions, changing the bath more frequently
may be advantageous
•warm water is recommended for filling the bath
•a suitable cleaning agent or combined disinfectant/cleaning agent must be added
•when using agents of this type, the concentration, temperature and ultrasound application
time must be appropriately set according to the manufacturer's instructions
Workflow
1. Dismantle the instruments and open the joint instruments as much as possible (if this
has not already been done)
2. Place the dismantled instruments in the appropriate container in the ultrasound bath.
When doing this, ensure that:
{the instruments are completely covered with cleaning solution
{instruments with a large area must be positioned in such a way as to avoid
ultrasound shadows or ultrasound dead zones
{do not overload the sieve trays
{to maximize cleaning performance, different materials and surface qualities should
not be mixed
If the ultrasound unit does not have a rinsing and drying chamber, follow steps 3 and 4:
3. The products must be rinsed under sterile or low microbial count (max. 10
microbes/ml) and low-endotoxin (max. 0.25 endotoxin units/ml) water (e.g. purified
water) until all residues have been removed
4. The products must then be dried with a lint-free cloth or with medical-grade
compressed air. Drying using compressed air is particularly gentle and effective, and
is therefore preferable to any other drying method, e.g. using a cloth
Pressure Rinsing the Screwdriver
•Once the sliding retaining spring has been removed, subject the screwdriver to a pressure
rinse with W&H Service Oil MD-400
•Follow the instructions listed below, as well as the operating instructions for the oil spray can
•For the rinse process, wrap the screwdriver head with a clean cloth to catch the oil
discharged from the head
•Insert the spray nozzle of the oil spray can into the grip of the screwdriver and spray for
approximately 2 seconds
•In certain positions, the screwdriver is leak tight. In these positions, pressure rinsing is not
possible. Couple the rotation knob and turn the drive 90°. In this new position, the pressure
rinse can be completed successfully
•After the rinse process, wait 2 - 3 seconds before removing the spray nozzle from the
instrument again so that the pressure built up inside the instrument can subside
•Repeat the pressure rinse until clean oil is discharged from the head
•Between rinse procedures, couple the rotation knob and use this to turn the drive a few more
times to loosen any contamination in the drive
•Note: for technical reasons, opening the drive is not permitted. This can only be done by
trained service personnel. For service and repairs, please send the instrument to your
nearest Medartis branch or distribution partner
Drying After the Pressure Rinse
•Place the sliding retaining spring back on the head from the front, attach the rotation knob
and verify that the drive operates freely
•Remove the rotation knob again
•Remove any excess oil,
{inside:
by carefully blowing out with compressed air (there must be no more oil
discharged from the head)
{outside:
by wiping off with cellulose or a soft cloth
•Store the screwdriver with the head downward
Disinfection
•Disinfection with surface disinfectants (wiping disinfection is recommmended!)
•Only use surface disinfectants which do not contain chlorine and are certified by officially
recognized institutions
•Use a disinfectant with proven effectiveness (such as VAH/DGHM or FDA approval or a CE
marking)
•Follow the manufacturer's instructions for the use of the surface disinfectant!
Checks
After cleaning or cleaning and disinfection, check the screwdriver for corrosion, damage to
surfaces, chipping, contaminants and function. Damaged screwdrivers may need to be
removed. Screwdrivers which are still dirty must be cleaned and disinfected again.

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
Page 4 of 4
Lubricating the Screwdriver
The correct lubrication is essential to ensure long service life of the product.
•Lubrication must be performed according to the instructions provided above ("Pressure
rinsing the screwdriver"), as well as in accordance with the directions in the operating
instructions for the oil spray can
•Perform lubrication with W&H Service Oil F1, MD-400
•Recommended care cycles: before each sterilization (spray into the instrument's coupling
tube)
Note on Packaging for Sterilization
Place the screwdriver, rotation knob and screwholding fork (separated from each other) in EN
868-5 compliant sterile device pouches and weld the seam to seal.
Sterilization
Only use the following sterilization methods. Other sterilization methods are not allowed.
Steam Sterilization
All NON-STERILE products can be steam sterilized in an autoclave (EN 13060). For both initial
and subsequent sterilization, the following parameters were verified by the manufacturer in
accordance with the requirements of the current sterilization standard:
Procedure Fractionated Vacuum
Procedure Flow Procedure
Exposure time > 3 min. > 3 min.
Temperature 134°C (273°F)
(+3°C) (37.4°F)
134°C (273°F)
(+3°C) (37.4°F)
Drying time > 20 min. - 30 min. > 20 min. - 30 min.
Medartis recommends using the fractionated vacuum procedure for sterilization with an
exposure time of ≥18 minutes.
Steam sterilization with the gravitation procedure needs to be verified by additional product-,
sterilizer- and process-specific validation.
In addition, do not use hot-air sterilization, radiation sterilization, formaldehyde sterilization,
ethylene oxide sterilization or substitute procedures for sterilizing thermolabile goods such as
plasma or peroxide sterilization.
Flash sterilization is not recommended. If this procedure is used, observe the respective
country-specific laws, standards, guidelines and instructions. The user is responsible for
reviewing these requirements and for obtaining the corresponding information.
After sterilization, the MODUS 90° Screwdriver must be stored in a dry environment.
Private Label Manufacturing and Sales Company
Medartis AG
Hochbergerstrasse 60E
4057 Basel/Switzerland
Caution: Consult accompanying documents
Batch number
Non-sterile
Do not reuse
Manufacturer:
Medartis AG,
4057 Basel/Switzerland
Marking for risk Class I medical devices, non-sterile and
without measuring function.